id|nct_id|ctgov_group_code|result_type|title|description
623569|NCT03125031|B1|Baseline|Test Subject|All subjects are enrolled into the test group and receive the Rainbow Adhesive Sensors (Rainbow Disposable Butterfly and Rainbow Disposable L).
623570|NCT03125031|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and receive the Rainbow Adhesive Sensors (Rainbow Disposable Butterfly and Rainbow Disposable L).
623571|NCT03125031|O2|Outcome|Group-Sensor 2|All subjects are enrolled into the test group and receive the Rainbow Adhesive Sensors (Rainbow Disposable L).
623572|NCT03125031|O1|Outcome|Group-Sensor 1|All subjects are enrolled into the test group and receive the Rainbow Adhesive Sensors (Rainbow Disposable Butterfly).
623573|NCT03125031|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and receive the Rainbow Adhesive Sensors (Rainbow Disposable Butterfly and Rainbow Disposable L).
623574|NCT03125005|B1|Baseline|Test Group|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
623575|NCT03125005|P1|Participant Flow|Test Group|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
623576|NCT03125005|O1|Outcome|Test Group|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
623577|NCT03125005|E1|Reported Event|Test Group|"All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.~Rainbow Universal Pulse Oximeter Sensor"
623578|NCT03124966|B1|Baseline|Test Group|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
623579|NCT03124966|P1|Participant Flow|Test Group|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
623580|NCT03124966|O1|Outcome|Test Group|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
623581|NCT03124966|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all will receive the pulse oximeter sensor.
623582|NCT03124927|B1|Baseline|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623583|NCT03124927|P1|Participant Flow|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623584|NCT03124927|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623585|NCT03124927|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623586|NCT03124901|B1|Baseline|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623587|NCT03124901|P1|Participant Flow|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623588|NCT03124901|O1|Outcome|Test Group|All subject are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623589|NCT03124901|E1|Reported Event|Test Group|All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.
623590|NCT03124771|B1|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow Reposable Adhesive Sensor.
623591|NCT03124771|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow Reposable Adhesive Sensor.
623592|NCT03124771|O1|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow Reposable Adhesive Sensor.
623593|NCT03124771|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the Rainbow Reposable Adhesive Sensor.
623594|NCT03124758|B1|Baseline|Test Subject|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
623595|NCT03124758|P1|Participant Flow|Test Subject|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
623596|NCT03124758|O1|Outcome|Test Subject|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
623597|NCT03124758|E1|Reported Event|Test Subject|All subjects are enrolled into the test group and all subjects received the Noninvasive Hemoglobin Sensor (Rainbow Reusable DCI, DCIP)
623598|NCT03124693|B1|Baseline|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
623599|NCT03124693|P1|Participant Flow|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
623600|NCT03124693|O1|Outcome|Test Group|All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.
623601|NCT03124693|E1|Reported Event|Test Group|"All subjects are enrolled into the test group and all subjects received the Rainbow DCI pulse oximeter sensor.~Rainbow DCI pulse oximeter sensor"
623602|NCT03106870|B3|Baseline|Total|Total of all reporting groups
623603|NCT03106870|B2|Baseline|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
623604|NCT03106870|B1|Baseline|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
623605|NCT03106870|P2|Participant Flow|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
623825|NCT03039179|B1|Baseline|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
623606|NCT03106870|P1|Participant Flow|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
623607|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
623608|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
623609|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
623610|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
623611|NCT03106870|O2|Outcome|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
623612|NCT03106870|O1|Outcome|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
623613|NCT03106870|E2|Reported Event|Insulin Therapy Only|"Intervention 'Insulin Mixtard' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
623614|NCT03106870|E1|Reported Event|Oral Metformin and Insulin|"Intervention 'Insulin Mixtard' and Intervention 'metformin' had included~Insulin Mixtard: Insulin dose:~0.7 IU/Kg (at the second trimester of pregnancy).~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration.~Metformin: Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
623615|NCT03106337|B1|Baseline|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
623616|NCT03106337|P1|Participant Flow|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
623617|NCT03106337|O2|Outcome|Shear-Wave Elastography, Malignant Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort Includes all participants with malignant lesions.
623618|NCT03106337|O1|Outcome|Shear-Wave Elastography, Benign Lesions|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort includes all participants with benign lesions.
623619|NCT03106337|E1|Reported Event|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
623620|NCT03072719|B3|Baseline|Total|Total of all reporting groups
623621|NCT03072719|B2|Baseline|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
623622|NCT03072719|B1|Baseline|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
623623|NCT03072719|P2|Participant Flow|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
623624|NCT03072719|P1|Participant Flow|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100 parts per million [ppm] as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
623625|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
623626|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
623627|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
623628|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
623629|NCT03072719|O2|Outcome|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
623630|NCT03072719|O1|Outcome|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
623631|NCT03072719|E2|Reported Event|Reference Dentifrice|Participants were instructed to dose a dry toothbrush according to their normal habit with reference dentifrice (0.76% sodium monofluorophosphate, 1000ppm as fluoride) and brushed the whole mouth thoroughly (as per the manufacturer’s instructions), for at least 1 minute.
623632|NCT03072719|E1|Reported Event|Experimental Dentifrice|Participants were instructed to dose a dry toothbrush with at least a 1-inch strip of the experimental dentifrice (0.454% Stannous Fluoride, 1100ppm as fluoride) and then to brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least 1 minute.
623633|NCT03070730|B4|Baseline|Total|Total of all reporting groups
623634|NCT03070730|B3|Baseline|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623635|NCT03070730|B2|Baseline|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623636|NCT03070730|B1|Baseline|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623637|NCT03070730|P3|Participant Flow|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623638|NCT03070730|P2|Participant Flow|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623639|NCT03070730|P1|Participant Flow|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623640|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623641|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623642|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623643|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623644|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623645|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623646|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623647|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623648|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623649|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623650|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623651|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623652|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623653|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623654|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623655|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623656|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623657|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623658|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623659|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623826|NCT03039179|P2|Participant Flow|Standard Care|Only application of the Walker in the immediate postoperative period.
623827|NCT03039179|P1|Participant Flow|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
623828|NCT03039179|O2|Outcome|Standard Care|
625917|NCT02724449|E1|Reported Event|Open-label Study|Single arm study
623660|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623661|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623662|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623663|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623664|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623665|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623666|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623667|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623668|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623669|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623670|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623671|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623672|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623673|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623674|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623829|NCT03039179|O1|Outcome|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
623830|NCT03039179|O2|Outcome|Standard Care|
623831|NCT03039179|O1|Outcome|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
623675|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623676|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623677|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623678|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623679|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623680|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623681|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623682|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623683|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623684|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623685|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623686|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623687|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623688|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623689|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623832|NCT03039179|E2|Reported Event|Standard Care|
623833|NCT03039179|E1|Reported Event|Polyurethane Foam|polyurethane foam dress: Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
623847|NCT03035955|B1|Baseline|Azelaic Acid Left/No Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
623690|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623691|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623692|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623693|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623694|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623695|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623696|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623697|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623698|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623699|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623700|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623701|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623702|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623703|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623704|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623835|NCT03037541|B2|Baseline|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
623836|NCT03037541|B1|Baseline|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
625918|NCT02723188|B4|Baseline|Total|Total of all reporting groups
623705|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623706|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623707|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623708|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623709|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623710|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623711|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623712|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623713|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623714|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623715|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623716|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623717|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623718|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623719|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623837|NCT03037541|P2|Participant Flow|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
623838|NCT03037541|P1|Participant Flow|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
623720|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623721|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623722|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623723|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623724|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623725|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623726|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623727|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623728|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623729|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623730|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623731|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623732|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623733|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623734|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623839|NCT03037541|O2|Outcome|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
623840|NCT03037541|O1|Outcome|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
626911|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
623735|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623736|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623737|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623738|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623739|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623740|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623741|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623742|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623743|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623744|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623745|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623746|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623747|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623748|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623749|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623841|NCT03037541|O2|Outcome|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
623842|NCT03037541|O1|Outcome|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
626912|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
623750|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623751|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623752|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623753|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623754|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623755|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623756|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623757|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623758|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623759|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623760|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623761|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623762|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623763|NCT03070730|O3|Outcome|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623764|NCT03070730|O2|Outcome|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623843|NCT03037541|E2|Reported Event|Group 2 Placebo|"Placebo Cetaphil cream applied daily on the face for one week~Placebo Cetaphil cream: Placebo Cetaphil Cream will be used once daily for seven consecutive days"
623844|NCT03037541|E1|Reported Event|Group 1 Carac (Fluorouracil) 0.5% Cream|"Carac cream (fluorouracil) 0.5% applied daily on the face for one week~Carac Cream: Carac Cream will be used once daily for seven consecutive days"
623765|NCT03070730|O1|Outcome|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623766|NCT03070730|E3|Reported Event|Droxidopa|"In this arm subjects are randomized to droxidopa 100 mg/300 mg tid, atenolol 50 mg qd, and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623767|NCT03070730|E2|Reported Event|Placebos|"In this arm subjects are randomized to placebo tid.~Placebo is used to control the administration effect.~Placebos: Placebo: t.i.d"
623768|NCT03070730|E1|Reported Event|Atenolol|"In this arm subjects are randomized to atenolol 50 mg qd, droxidopa 100 mg/300 mg tid and placebo tid.~Atenolol is used to examine the effect of non-selective beta adrenoreceptor antagonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia patients.~Droxidopa is used to examine the effect of direct alpha-1 adrenoreceptor agonist on primary and secondary endpoints in neuropathic and non-neuropathic postural tachycardia (POTS) patients.~Droxidopa: Droxidopa: 100 mg or 300 mg t.i.d~Atenolol: Atenolol: 50 mg Q.D.~Placebos: Placebo: t.i.d"
623769|NCT03065933|B1|Baseline|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
623770|NCT03065933|P1|Participant Flow|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
623771|NCT03065933|O1|Outcome|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
623772|NCT03065933|E1|Reported Event|Clonidine as an Antimanic Agent|"Subjects with Bipolar Disorder, Mania receive an extended-release form of clonidine on the second day of this 3-day study. Rating scales, record of sleep, and a questionnaire of adverse effects is recorded on each of the three days.~extended-release clonidine: Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study."
623773|NCT03061513|B3|Baseline|Total|Total of all reporting groups
623774|NCT03061513|B2|Baseline|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
623775|NCT03061513|B1|Baseline|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
623776|NCT03061513|P2|Participant Flow|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
623777|NCT03061513|P1|Participant Flow|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
623778|NCT03061513|O2|Outcome|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
623779|NCT03061513|O1|Outcome|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
623780|NCT03061513|O2|Outcome|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
623781|NCT03061513|O1|Outcome|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
623782|NCT03061513|E2|Reported Event|Placebo|"Placebo daily for 24 weeks~Placebo: placebo"
623783|NCT03061513|E1|Reported Event|Ubiquinol|"600mg ubiquinol daily for 24 weeks~Ubiquinol: Ubiquinol caplets 600mg/day"
623784|NCT03048006|B1|Baseline|All Included Patients|All included patients underwent MRI with Dotarem
623785|NCT03048006|P1|Participant Flow|All Included Patients|All included patients underwent MRI with Dotarem
623786|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
623787|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
623788|NCT03048006|O1|Outcome|All Included Patients|All included patients underwent MRI with Dotarem
623789|NCT03048006|E1|Reported Event|All Included Patients|All included patients underwent MRI with Dotarem
623790|NCT03047447|B4|Baseline|Total|Total of all reporting groups
623791|NCT03047447|B3|Baseline|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623792|NCT03047447|B2|Baseline|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623845|NCT03035955|B3|Baseline|Total|Total of all reporting groups
623846|NCT03035955|B2|Baseline|Azelaic Acid Right/No Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
623950|NCT03022435|O4|Outcome|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623793|NCT03047447|B1|Baseline|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623794|NCT03047447|P3|Participant Flow|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623795|NCT03047447|P2|Participant Flow|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623796|NCT03047447|P1|Participant Flow|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623797|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623798|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623799|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623800|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623801|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623802|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623803|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623804|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
626913|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
623805|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623806|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=.211"
623807|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.11"
623808|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.00"
623809|NCT03047447|O3|Outcome|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=.211"
623810|NCT03047447|O2|Outcome|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.11"
623811|NCT03047447|O1|Outcome|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes.~p=0.00"
623812|NCT03047447|E3|Reported Event|Non-exercise|"Non-exercise group maintained normal diet for 10-weeks with no exercise. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623813|NCT03047447|E2|Reported Event|Exercise Group|"Exercise group maintained normal diet for 10-weeks and exercised 3-5 days per week. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623814|NCT03047447|E1|Reported Event|Ketogenic Group|"10-week diet with controlled glycemic indices provided for ketogenic group. Baseline triglyceride, HgA1c, VO2 max, body mass index (BMI), resting metabolic rate (RMR), blood ketone levels and body fat mass measurements were assessed at week 0 and week 3, 6 and 10.~Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome: 30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant’s normal diet with no exercise, or participant’s normal diet with 3-5 days per week of exercise for 30 minutes"
623815|NCT03041298|B1|Baseline|All Included Patients|All included patients underwent MR mammography with Dotarem.
623816|NCT03041298|P1|Participant Flow|All Included Patients|All included patients underwent MR mammography with Dotarem.
623817|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
623818|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
623819|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
623820|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
623821|NCT03041298|O1|Outcome|All Included Patients|All included patients underwent MR mammography with Dotarem.
623822|NCT03041298|E1|Reported Event|All Included Patients|All included patients underwent MR mammography with Dotarem.
623823|NCT03039179|B3|Baseline|Total|Total of all reporting groups
623824|NCT03039179|B2|Baseline|Standard Care|
623834|NCT03037541|B3|Baseline|Total|Total of all reporting groups
623848|NCT03035955|P2|Participant Flow|Azelaic Acid Right/No Treatment Left|"azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face~Azelaic acid: 15% gel twice daily for four weeks to the right side of face"
623849|NCT03035955|P1|Participant Flow|Azelaic Acid Left/No Treatment Right|"azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face~Azelaic acid: 15% gel twice daily for four weeks to the left side of face"
623850|NCT03035955|O2|Outcome|Azelaic Acid Right /no Treatment Left|azelaic acid (Finacea® Gel, 15%) twice daily on the right side side of the face and no treatment on the left side of the face
623851|NCT03035955|O1|Outcome|Azelaic Acid Left/no Treatment Right|azelaic acid (Finacea® Gel, 15%) twice daily on the left side side of the face and no treatment on the right side of the face
623852|NCT03035955|E2|Reported Event|no Treatment|no treatment on the other side of the face
623853|NCT03035955|E1|Reported Event|Azelaic Acid|"azelaic acid (Finacea® Gel, 15%) twice daily on either the left side or the right side of the face and no treatment on the other side of the face~Azelaic acid: 15% gel twice daily for four weeks to one side of face"
623854|NCT03026803|B1|Baseline|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
623855|NCT03026803|P1|Participant Flow|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
623856|NCT03026803|O1|Outcome|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
623857|NCT03026803|E1|Reported Event|Oxaliplatin and Capecitabine|"21 day cycle with Oxaliplatin 50mg/m^2 day 1 and day 8 administered IV, Capecitabine 750 mg/m^2 bid p.o. daily from day 1 to day 14~Oxaliplatin: Given IV~Capecitabine: Given PO"
623858|NCT03023709|B3|Baseline|Total|Total of all reporting groups
623859|NCT03023709|B2|Baseline|Study Phase (LAIV4)|"Participants will be given quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
623860|NCT03023709|B1|Baseline|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
623861|NCT03023709|P2|Participant Flow|Study Phase (LAIV4)|"Participants will be given the quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4), FluMist®, intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
623862|NCT03023709|P1|Participant Flow|Pilot Phase (IIV4)|"Participants will receive the seasonal quadrivalent, inactivated influenza vaccine (IIV4), Fluzone®, given intramuscularly to confirm the safety of administering licensed seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
623863|NCT03023709|O2|Outcome|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
623864|NCT03023709|O1|Outcome|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
623865|NCT03023709|O2|Outcome|Study Phase|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
623866|NCT03023709|O1|Outcome|Pilot Phase|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
623867|NCT03023709|E2|Reported Event|Study Phase (LAIV4)|"Participants will be given the current year's quadrivalent, live, attenuated seasonal influenza vaccine (LAIV4)/FluMist® intranasally 3-14 days prior to tonsillectomy.~FluMist®: quadrivalent, live, attenuated influenza vaccine, intranasal spray"
623868|NCT03023709|E1|Reported Event|Pilot Phase (IIV4)|"Participants will receive the current seasonal quadrivalent, inactivated influenza vaccine (IIV4)/Fluzone® given intramuscularly to confirm the safety of administering the seasonal influenza vaccine 3-14 days prior to tonsillectomy.~Fluzone®: quadrivalent, inactivated influenza virus vaccine, intramuscular"
623869|NCT03023683|B3|Baseline|Total|Total of all reporting groups
623870|NCT03023683|B2|Baseline|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623871|NCT03023683|B1|Baseline|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623872|NCT03023683|P2|Participant Flow|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623873|NCT03023683|P1|Participant Flow|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623874|NCT03023683|O2|Outcome|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623875|NCT03023683|O1|Outcome|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623876|NCT03023683|O2|Outcome|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623877|NCT03023683|O1|Outcome|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623878|NCT03023683|E2|Reported Event|Group B: 18-49 yo Healthy Non-twins|"Participants will be given seasonal LAIV, FluMist® .~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623879|NCT03023683|E1|Reported Event|Group A: 2-8 yo Healthy Non-twins|"Participants will be given seasonal live, attenuated influenza vaccine (LAIV), FluMist® . Children with no prior influenza vaccine history will receive a second dose of LAIV at least 28 days after the first study dose.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623880|NCT03023553|B3|Baseline|Total|Total of all reporting groups
623881|NCT03023553|B2|Baseline|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623882|NCT03023553|B1|Baseline|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623883|NCT03023553|P2|Participant Flow|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623884|NCT03023553|P1|Participant Flow|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623885|NCT03023553|O2|Outcome|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623886|NCT03023553|O1|Outcome|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623887|NCT03023553|O2|Outcome|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623888|NCT03023553|O1|Outcome|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623889|NCT03023553|E2|Reported Event|LAIV Group|"Healthy adult males and females, 18-30 years of age. Immunize with intranasal live, attenuated influenza vaccine (LAIV), FluMist®.~FluMist®: Influenza Virus Vaccine Live, Intranasal Spray"
623890|NCT03023553|E1|Reported Event|TIV/ Control Group|"Healthy adult males and females, 18-30 years of age. Immunization with standard trivalent, inactivated influenza vaccine (TIV), Fluzone®.~Fluzone®: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623891|NCT03023488|B1|Baseline|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623892|NCT03023488|P1|Participant Flow|Flexible Ureteroscopy Arm|"Doppler Ultrasound examination was performed in both the pre-operative and post-operative periods on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623893|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The number of patients who had a complication after the flexible ureteroscopy operation in the first month following the operation.~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623894|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The number of patients that had a complication intraoperatively.~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
625496|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
623895|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The pressure applied to the irrigation solution during a flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623896|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The duration of the flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623897|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"The type of the ureteroscope used for the flexible ureteroscopy operation~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623898|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623899|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623900|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623901|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623902|NCT03023488|O1|Outcome|Flexible Ureteroscopy Arm|"pre-operative and post-operative findings of renal Doppler Ultrasound examination on the operated kidney of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
625497|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
623903|NCT03023488|E1|Reported Event|Flexible Ureteroscopy Arm|"findings of patients undergoing flexible ureteroscopy + laser lithotripsy for renal stones according to EAU Guidelines~Flexible ureteroscopy is an endourological procedure performed for kidney stones. flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and to provide clear vision.~Doppler Ultrasound examination: peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.~laser lithotripsy: The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and trans"
623904|NCT03023176|B1|Baseline|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
623905|NCT03023176|P1|Participant Flow|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
623906|NCT03023176|O1|Outcome|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
623907|NCT03023176|O1|Outcome|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
623908|NCT03023176|E1|Reported Event|Healthy 1-8 Year-old Twins|"Healthy 1-8 yr old identical and fraternal twin pairs given trivalent, inactivated influenza (Fluzone® standard IIV3 0.5ml or Fluzone® standard IIV3 Pediatric Dose) per participant age and standard of care.~Fluzone® standard IIV3: Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection~Fluzone® standard IIV3 Pediatric Dose: Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection"
623909|NCT03023137|B3|Baseline|Total|Total of all reporting groups
623910|NCT03023137|B2|Baseline|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623911|NCT03023137|B1|Baseline|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrolment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623912|NCT03023137|P2|Participant Flow|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623913|NCT03023137|P1|Participant Flow|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623914|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623915|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623916|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623951|NCT03022435|O3|Outcome|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
623952|NCT03022435|O2|Outcome|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
627133|NCT02656485|B5|Baseline|Total|Total of all reporting groups
623917|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623918|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623919|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623920|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623921|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623922|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623923|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623924|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623925|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623926|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623927|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623928|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623953|NCT03022435|O1|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray
623954|NCT03022435|O5|Outcome|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
623929|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623930|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623931|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623932|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623933|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623934|NCT03023137|O2|Outcome|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623935|NCT03023137|O1|Outcome|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet would be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages and large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623936|NCT03023137|E2|Reported Event|Controls|No recommendations regarding diet or physical activity were given to controls. Antiemetics such as ondansetron would be given to controls complaining of vomiting.
623937|NCT03023137|E1|Reported Event|Walking & Dietary Modification (W&D)|"The intervention was standardized by training of research staff and should begin when participants wish to conceive. Careful instructions about walking speed and diet will be given to participants assigned to W&D at enrollment and at each consultation.~Walking & dietary modification: 1. Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those whose jobs required them to seat for long periods should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, such as near term.~2. At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water, sugar-sweetened beverages or large amount of fruits. Sucralose could be used as a sweetener. Participants were recommended to use ondansetron for nausea and vomiting prevention"
623938|NCT03022435|B6|Baseline|Total|Total of all reporting groups
623939|NCT03022435|B5|Baseline|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
623940|NCT03022435|B4|Baseline|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623941|NCT03022435|B3|Baseline|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623942|NCT03022435|B2|Baseline|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623943|NCT03022435|B1|Baseline|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
623944|NCT03022435|P5|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
623945|NCT03022435|P4|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623946|NCT03022435|P3|Participant Flow|Group D: 40 - 64 yo Identical Twins|Participants to receive Fluzone® standard TIV
623947|NCT03022435|P2|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623948|NCT03022435|P1|Participant Flow|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
623949|NCT03022435|O5|Outcome|Group F: 65 - 100 yo Identical Twins (High Dose TIV)|Participants to receive High-Dose Fluzone® standardTIV
623955|NCT03022435|O4|Outcome|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623956|NCT03022435|O3|Outcome|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623957|NCT03022435|O2|Outcome|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623958|NCT03022435|O1|Outcome|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
623959|NCT03022435|E5|Reported Event|Group F: 65 - 100 yo Identical Twins (High-Dose TIV)|Participants to receive High-Dose Fluzone® standard TIV
623960|NCT03022435|E4|Reported Event|Group F: 65 - 100 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623961|NCT03022435|E3|Reported Event|Group D: 40 - 64 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623962|NCT03022435|E2|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|Participants to receive Fluzone® standard TIV
623963|NCT03022435|E1|Reported Event|Group B: 18-30 yo Identical Twins (LAIV)|Participants to receive FluMist® LAIV by nasal spray.
623964|NCT03022422|B7|Baseline|Total|Total of all reporting groups
623965|NCT03022422|B6|Baseline|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Participants will receive Fluzone® high-dose TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
623966|NCT03022422|B5|Baseline|Group F: 65-100 yo Identical Twins (TIV)|Participants will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
623967|NCT03022422|B4|Baseline|Group E: 40-64 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623968|NCT03022422|B3|Baseline|Group D: 40-64 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623969|NCT03022422|B2|Baseline|Group C: 18-30 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623970|NCT03022422|B1|Baseline|Group B: 18-30 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623971|NCT03022422|P6|Participant Flow|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
623972|NCT03022422|P5|Participant Flow|Group F: 65-100 yo Identical Twins (TIV)|Participants will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
623973|NCT03022422|P4|Participant Flow|Group E: 40-64 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623974|NCT03022422|P3|Participant Flow|Group D: 40-64 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623975|NCT03022422|P2|Participant Flow|Group C: 18-30 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623976|NCT03022422|P1|Participant Flow|Group B: 18-30 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623977|NCT03022422|O6|Outcome|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
623978|NCT03022422|O5|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Participants will receive Fluzone® TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
623979|NCT03022422|O4|Outcome|Group E: 40-64 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623980|NCT03022422|O3|Outcome|Group D: 40-64 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623981|NCT03022422|O2|Outcome|Group C: 18-30 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623982|NCT03022422|O1|Outcome|Group B: 18-30 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623983|NCT03022422|O6|Outcome|Group F: 65-100 yo Identical Twins (High-DoseTIV)|Participants will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
623984|NCT03022422|O5|Outcome|Group F: 65-100 yo Identical Twins (TIV)|Participants will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
623985|NCT03022422|O4|Outcome|Group E: 40-64 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623986|NCT03022422|O3|Outcome|Group D: 40-64 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623987|NCT03022422|O2|Outcome|Group C: 18-30 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623988|NCT03022422|O1|Outcome|Group B: 18-30 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623989|NCT03022422|E6|Reported Event|Group F: 65-100 yo Identical Twins (High-Dose TIV)|Participants will receive High-Dose Fluzone® TIV: High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for Intramuscular Injection
623990|NCT03022422|E5|Reported Event|Group F: 65-100 yo Identical Twins (TIV)|Participants will receive Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection
623991|NCT03022422|E4|Reported Event|Group E: 40-64 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
625498|NCT02750709|E3|Reported Event|Reference Product|ORFADIN® hard capsule, 10 mg
623992|NCT03022422|E3|Reported Event|Group D: 40-64 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623993|NCT03022422|E2|Reported Event|Group C: 18-30 yo Fraternal Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623994|NCT03022422|E1|Reported Event|Group B: 18-30 yo Identical Twins (TIV)|"Participants to receive Fluzone® standard TIV~Fluzone® standard TIV: Influenza Virus Vaccine Suspension for Intramuscular Injection"
623995|NCT03020537|B3|Baseline|Total|Total of all reporting groups
623996|NCT03020537|B2|Baseline|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
623997|NCT03020537|B1|Baseline|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
623998|NCT03020537|P2|Participant Flow|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
623999|NCT03020537|P1|Participant Flow|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
624000|NCT03020537|O2|Outcome|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
624001|NCT03020537|O1|Outcome|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
624002|NCT03020537|O2|Outcome|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
624003|NCT03020537|O1|Outcome|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
624004|NCT03020537|E2|Reported Event|Group B: 18-30 Years Old|"Group B: 18-30 years old, who did not receive the 20l2-2013 seasonal influenza vaccine. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone.~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
624005|NCT03020537|E1|Reported Event|Group A: 1 - 2 Years Old|"Group A: 1-2 years old, seasonal influenza vaccine-naive. Given intramuscular,inactivated influenza vaccine-trivalent (IM IIV3) - Fluzone (pediatric formulation).~Fluzone: Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula."
624006|NCT03020498|B4|Baseline|Total|Total of all reporting groups
624007|NCT03020498|B3|Baseline|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
624008|NCT03020498|B2|Baseline|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624009|NCT03020498|B1|Baseline|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624010|NCT03020498|P3|Participant Flow|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
624011|NCT03020498|P2|Participant Flow|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624012|NCT03020498|P1|Participant Flow|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624013|NCT03020498|O3|Outcome|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
624014|NCT03020498|O2|Outcome|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624015|NCT03020498|O1|Outcome|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624016|NCT03020498|O3|Outcome|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
624017|NCT03020498|O2|Outcome|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624018|NCT03020498|O1|Outcome|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624019|NCT03020498|E3|Reported Event|Group C: 70-100 yo Non-twin|"Group C: 70-100 years old non-twin elderly adults given Fluzone (trivalent, inactivated influenza vaccine (TIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection"
624020|NCT03020498|E2|Reported Event|Group B: 8-30 yo Non-twin|"Group B: 8-30 years old non-twin individuals given Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV))~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624021|NCT03020498|E1|Reported Event|Group A: 8-17 yo Identical Twins|"Group A: 8-17 year-old identical twin pairs randomly assigned to Fluzone (trivalent, inactivated influenza vaccine (TIV)) or FluMist (live, attenuated influenza vaccine (LAIV)) within the pair~Fluzone: Influenza Virus Vaccine Suspension for Intramuscular Injection~FluMist: Influenza Virus Vaccine Live, Intranasal Intranasal Spray"
624022|NCT03020472|B1|Baseline|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
624023|NCT03020472|P1|Participant Flow|2008-2009 FluMist LAIV (Intranasal)|"Seasonal live, attenuated influenza vaccine (LAIV)~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
624024|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
624025|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
624026|NCT03020472|O1|Outcome|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
624027|NCT03020472|E1|Reported Event|2008-2009 FluMist LAIV (Intranasal)|"2008-2009 FluMist LAIV (Intranasal) Seasonal live, attenuated influenza vaccine~2008-2009 FluMist LAIV (Intranasal): 2008-2009 FluMist vaccine delivered intranasally"
624028|NCT03019783|B3|Baseline|Total|Total of all reporting groups
624029|NCT03019783|B2|Baseline|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
624030|NCT03019783|B1|Baseline|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
624031|NCT03019783|P2|Participant Flow|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
624032|NCT03019783|P1|Participant Flow|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
624033|NCT03019783|O2|Outcome|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
624034|NCT03019783|O1|Outcome|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
624035|NCT03019783|O2|Outcome|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
624036|NCT03019783|O1|Outcome|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
624037|NCT03019783|E2|Reported Event|Atazanavir Switch|"These subjects are switched to an atazanavir-based regimen.~Atazanavir: The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen."
624038|NCT03019783|E1|Reported Event|Remains on Baseline HIV Regimen|"Subjects are enrolled and either kept on their baseline regimen. This is being designated the placebo comparator.~Placebo: The control group will stay on their baseline regimen"
624039|NCT03001674|B3|Baseline|Total|Total of all reporting groups
624040|NCT03001674|B2|Baseline|Control|Conductance catheterization: CD Leycom Conductance Catheter
624041|NCT03001674|B1|Baseline|IABP Recipient|Conductance catheterization: CD Leycom Conductance Catheter
624042|NCT03001674|P2|Participant Flow|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
624043|NCT03001674|P1|Participant Flow|IABP Recipient|"Prospective, double-arm, pilot study.~Conductance catheterization: CD Leycom Conductance Catheter"
624044|NCT03001674|O2|Outcome|Control|"Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.~Conductance catheterization: CD Leycom Conductance Catheter"
624045|NCT03001674|O1|Outcome|IABP Recipient|"Referred for clinically indicated right heart catheterization with intervention of IABP placement prior to LVAD surgery.~Conductance catheterization: CD Leycom Conductance Catheter"
624046|NCT03001674|E2|Reported Event|Control Group|Control subjects undergoing left heart catheterization with an LV ejection fraction > 50%, and without a history of heart failure symptoms who did not receive IABP therapy were enrolled.
624047|NCT03001674|E1|Reported Event|IABP Recipient|"Prospective, double-arm, pilot study.~Conductance catheterization: CD Leycom Conductance Catheter"
624048|NCT03001258|B4|Baseline|Total|Total of all reporting groups
624049|NCT03001258|B3|Baseline|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
624050|NCT03001258|B2|Baseline|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity."
624051|NCT03001258|B1|Baseline|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity.~A total of 40 eye camps were held in two sub districts by eight POs."
624052|NCT03001258|P3|Participant Flow|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
624053|NCT03001258|P2|Participant Flow|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, 20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the total 40 eye camps.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as"
624054|NCT03001258|P1|Participant Flow|PO (Program Organizers)|"PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided.~A total of eight POs organized eye camps in two sub districts. POs were responsible for identifying the presbyopia patients through screening and SS assisted in organizing and mobilizing the community people for the eye camps, and glass sale (on the spot). Four camps were organized per day for five days by four POs in each sub-district. A total of 40 eye camps were held in two sub districts by eight POs.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and managemen"
624055|NCT03001258|O3|Outcome|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
624077|NCT02988219|O2|Outcome|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
624078|NCT02988219|O1|Outcome|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624364|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624056|NCT03001258|O2|Outcome|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new caddre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
624057|NCT03001258|O1|Outcome|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity. A total of 40 eye camps were held in two sub districts by eight POs.
624058|NCT03001258|E3|Reported Event|SS (Shashthya Shebika)|"SS: Community health workers of Brac. A two day presbyopia screening training were provided.~In this arm, the SS, undertook the screening of potential presbyopia cases. A total of 27 SS organized 25 eye camps in eight days in two upazilas.~Presbyopia screening training: The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
624059|NCT03001258|E2|Reported Event|USS (Upgraded Shashthya Shebika)|"USS (Upgraded Shashthya Shebika): A new cadre of community health workers of Brac. A two day presbyopia screening training were provided.~20 USSs were assigned in two upazillas to run the two camp-day i.e. screening patients and selling glasses during the eye camps.~The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity"
624060|NCT03001258|E1|Reported Event|PO (Program Organizers)|PO (program organizers): Employed by Brac as field level organizers. A two day presbyopia screening training were provided. The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity A total of 40 eye camps were held in two sub districts by eight POs.
624061|NCT03000088|B3|Baseline|Total|Total of all reporting groups
624062|NCT03000088|B2|Baseline|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
624063|NCT03000088|B1|Baseline|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
624064|NCT03000088|P2|Participant Flow|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
624065|NCT03000088|P1|Participant Flow|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
624066|NCT03000088|O2|Outcome|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
624067|NCT03000088|O1|Outcome|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
624068|NCT03000088|E2|Reported Event|90°Angle Group|"intubate using McGrath Videolaryngoscope with 90° angled stylet~intubate with 60° angled stylet"
624069|NCT03000088|E1|Reported Event|60° Angle Group|"intubate using McGrath Videolaryngoscope with 60° angled stylet~intubate with 60° angled stylet"
624070|NCT02988219|B3|Baseline|Total|Total of all reporting groups
624071|NCT02988219|B2|Baseline|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624072|NCT02988219|B1|Baseline|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624073|NCT02988219|P2|Participant Flow|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624074|NCT02988219|P1|Participant Flow|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624075|NCT02988219|O2|Outcome|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position General anesthesia
624076|NCT02988219|O1|Outcome|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624079|NCT02988219|E2|Reported Event|Combined General/Epidural (G/E)|General anesthesia Epidural anesthesia: Local anesthetic Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624080|NCT02988219|E1|Reported Event|General Anesthesia (G)|General anesthesia Holter ECG monitor: 3-chanel, CM5 leads Open kidney cancer surgery: Lateral position
624081|NCT02987374|B1|Baseline|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
624082|NCT02987374|P1|Participant Flow|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
624083|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
624084|NCT02987374|O1|Outcome|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
624085|NCT02987374|E1|Reported Event|2011-2012 Fluzone IIV3 (IM)|"2011-2012 Fluzone IIV3 NDC No 49281-011-50~2011-2012 Fluzone IIV3: This vaccine is given intramuscularly (IM)"
624086|NCT02974543|B3|Baseline|Total|Total of all reporting groups
624087|NCT02974543|B2|Baseline|Sham 1st (Auditory Only) Then Active (Bimodal)|To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. During active treatment, the device will deliver electric somatosensory and auditory stimulation. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
624088|NCT02974543|B1|Baseline|Active 1st (Bimodal) Then Sham (Auditory Only)|During active treatment the device will deliver electric somatosensory and auditory stimulation. To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab. Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment. Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, determined by how the subject can modulate the tinnitus. The auditory stimulus will be individualized based on subjects' tinnitus spectrum.
624089|NCT02974543|P2|Participant Flow|Active (Bimodal) Then Sham (Auditory Only)|"During active treatment, the device will deliver electric somatosensory and auditory stimulation.~To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.~Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.~Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.~The auditory stimulus will be individualized based on s"
624090|NCT02974543|P1|Participant Flow|Sham 1st (Auditory Only) Then Active (Bimodal)|"To mitigate potential placebo effects, subjects receive both a sham treatment and an active treatment. The subjects will be blinded to which treatment they are receiving. Both treatments are delivered using a take-home device programmed in the lab.~During active treatment, the device will deliver electric somatosensory and auditory stimulation.~Sham Treatment: unimodal auditory stimulation: All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.~Active Treatment: Bimodal auditory-somatosensory stimulation: Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.~The auditory stimulus will be individualized based on s"
624091|NCT02974543|O6|Outcome|Active After Sham|
624092|NCT02974543|O5|Outcome|Washout After Sham|
624093|NCT02974543|O4|Outcome|Sham Before Active|
624094|NCT02974543|O3|Outcome|Sham After Active|
624095|NCT02974543|O2|Outcome|Washout After Active|
624096|NCT02974543|O1|Outcome|Active Before Sham|
624097|NCT02974543|O6|Outcome|Active After Sham|
624098|NCT02974543|O5|Outcome|Washout After Sham|
624099|NCT02974543|O4|Outcome|Sham Before Active|
624100|NCT02974543|O3|Outcome|Sham After Active|
624101|NCT02974543|O2|Outcome|Washout After Active|
624102|NCT02974543|O1|Outcome|Active Before Sham|
624103|NCT02974543|E6|Reported Event|Active After Sham|
624104|NCT02974543|E5|Reported Event|Washout After Sham|
624105|NCT02974543|E4|Reported Event|Sham Before Active|
624106|NCT02974543|E3|Reported Event|Sham After Active|
624107|NCT02974543|E2|Reported Event|Washout After Active|
624108|NCT02974543|E1|Reported Event|Active Before Sham|
624109|NCT02971670|B5|Baseline|Total|Total of all reporting groups
624110|NCT02971670|B4|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624155|NCT02958995|E1|Reported Event|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
624111|NCT02971670|B3|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624112|NCT02971670|B2|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624113|NCT02971670|B1|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624114|NCT02971670|P4|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624115|NCT02971670|P3|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624116|NCT02971670|P2|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624117|NCT02971670|P1|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624118|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624119|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624120|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624121|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624122|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624123|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624124|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624125|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624126|NCT02971670|O4|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624127|NCT02971670|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624128|NCT02971670|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624156|NCT02958956|B3|Baseline|Total|Total of all reporting groups
625499|NCT02750709|E2|Reported Event|Test Product 2|Nitisinone Tablet (High Compritol), 10 mg
624129|NCT02971670|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624130|NCT02971670|E4|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624131|NCT02971670|E3|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624132|NCT02971670|E2|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624133|NCT02971670|E1|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 – 3) from Phase I."
624134|NCT02961244|B3|Baseline|Total|Total of all reporting groups
624135|NCT02961244|B2|Baseline|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
624136|NCT02961244|B1|Baseline|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
624137|NCT02961244|P2|Participant Flow|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
624138|NCT02961244|P1|Participant Flow|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
624139|NCT02961244|O2|Outcome|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
624140|NCT02961244|O1|Outcome|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
624141|NCT02961244|O2|Outcome|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
624142|NCT02961244|O1|Outcome|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
624143|NCT02961244|E2|Reported Event|Intervention Group|"Perioperative management and warming was performed according to a standard normothermia protocol with active prewarming.~Prewarming and perioperative warming with Forced Air Warming device and its blankets.~Forced Air Warming blanket"
624144|NCT02961244|E1|Reported Event|Control Group|Perioperative management and warming was not performed according to a standard normothermia protocol, with our clinic's traditional methods except prewarming.
624145|NCT02958995|B3|Baseline|Total|Total of all reporting groups
624146|NCT02958995|B2|Baseline|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
624147|NCT02958995|B1|Baseline|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
624148|NCT02958995|P2|Participant Flow|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
624149|NCT02958995|P1|Participant Flow|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
624150|NCT02958995|O2|Outcome|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
624151|NCT02958995|O1|Outcome|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
624152|NCT02958995|O2|Outcome|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
624153|NCT02958995|O1|Outcome|Full KPNC Cohort|Participants who were members of the KPNC registry (with or without diabetes) were followed up to 15 years (1997-2011) in this epidemiological study.
624154|NCT02958995|E2|Reported Event|Survey Responders Cohort|A subset of KPNC members who completed the Kaiser Diabetes Registry Survey in 1994-1996 and among a random sample of KPNC members who completed the Member Health Survey (MHS), in 1996, 1999, 2002, or 2005 were followed up to 15 years (1997-2011) in this epidemiological study.
624358|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624157|NCT02958956|B2|Baseline|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
624158|NCT02958956|B1|Baseline|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
624159|NCT02958956|P2|Participant Flow|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
624160|NCT02958956|P1|Participant Flow|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
624161|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
624162|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
624163|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
624164|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
624165|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
624166|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
624167|NCT02958956|O2|Outcome|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
624168|NCT02958956|O1|Outcome|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
624169|NCT02958956|O1|Outcome|Full Cohort|Participants with diabetes who were members of the KPNC registry, who received (ever use) at least 2 prescriptions for pioglitazone within a 6-month period or who did not receive pioglitazone were followed up to 15.5 years (1997-2012) in this observational study.
624170|NCT02958956|E2|Reported Event|Never User of Pioglitazone|Never user of pioglitazone, which included participants receiving no diabetes medications, with fewer than 2 pioglitazone prescription fills in a 6-month period, and with use of diabetes medications other than pioglitazone.
624171|NCT02958956|E1|Reported Event|Ever User of Pioglitazone|Ever user of pioglitazone was defined as having filled 2 prescriptions for the drug within a 6-month period.
624172|NCT02951767|B1|Baseline|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624173|NCT02951767|P1|Participant Flow|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624174|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624175|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624176|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624177|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624178|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624179|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624180|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624181|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624363|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624182|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624183|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624184|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624185|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624186|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624187|NCT02951767|O1|Outcome|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624188|NCT02951767|E1|Reported Event|Cohort 1: Treatment-naive Cisplatin Ineligible Participants|Participants with advanced disease who were treatment-naive for advanced urothelial carcinoma and cisplatin ineligible received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
624189|NCT02947984|B3|Baseline|Total|Total of all reporting groups
624190|NCT02947984|B2|Baseline|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
624191|NCT02947984|B1|Baseline|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
624192|NCT02947984|P2|Participant Flow|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
624193|NCT02947984|P1|Participant Flow|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
624194|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
624195|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
624196|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
624197|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
624198|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
624199|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
624200|NCT02947984|O2|Outcome|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
624201|NCT02947984|O1|Outcome|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
624202|NCT02947984|E2|Reported Event|Higher Dose Treatment|"63 CGE in 35 treatments of 1.8 CGE given once a day, for five days of each week.~Higher Dose: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT."
624203|NCT02947984|E1|Reported Event|Standard Treatment|"Standard radiation therapy: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Standard Treatment: 55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week.~Treatment based upon a treatment planning CT."
624204|NCT02941640|B5|Baseline|Total|Total of all reporting groups
624205|NCT02941640|B4|Baseline|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624206|NCT02941640|B3|Baseline|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
625500|NCT02750709|E1|Reported Event|Test Product 1|Nitisinone Tablet, 10 mg
624207|NCT02941640|B2|Baseline|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624208|NCT02941640|B1|Baseline|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624209|NCT02941640|P4|Participant Flow|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624210|NCT02941640|P3|Participant Flow|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624211|NCT02941640|P2|Participant Flow|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624212|NCT02941640|P1|Participant Flow|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624213|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624214|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624215|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624216|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624217|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624218|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624219|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624220|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624221|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624222|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624223|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624224|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624225|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624226|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624227|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624228|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624229|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624230|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624231|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624232|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624233|NCT02941640|O4|Outcome|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624234|NCT02941640|O3|Outcome|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624235|NCT02941640|O2|Outcome|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624236|NCT02941640|O1|Outcome|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624237|NCT02941640|E4|Reported Event|Laparoscopic Appendectomy. DS Clip|"Laparoscopic appendectomy.The securing the base of appendix by DS clip.~Laparoscopic appendectomy: The securing the base of appendix by DS clip.~DS clip"
624238|NCT02941640|E3|Reported Event|Laparoscopic Appendectomy. Hem-o-lok Clip|"Laparoscopic appendectomy. The securing the base of appendix by Hem-o-lok clip.~Laparoscopic appendectomy: The securing the base of appendix by Hem-o-lok clip.~Hem-o-lok clip"
624239|NCT02941640|E2|Reported Event|Laparoscopic Appendectomy. Stapler|"Laparoscopic appendectomy. The securing the base of appendix by stapler.~Laparoscopic appendectomy: The securing the base of appendix by Stapler.~Stapler"
624240|NCT02941640|E1|Reported Event|Laparoscopic Appendectomy. Endoloop.|"Laparoscopic appendectomy. The securing the base of appendix by endo-loop.~Laparoscopic appendectomy: The securing the base of appendix by endoloop.~Endoloop"
624241|NCT02934347|B3|Baseline|Total|Total of all reporting groups
624242|NCT02934347|B2|Baseline|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
624243|NCT02934347|B1|Baseline|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
624244|NCT02934347|P2|Participant Flow|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
624245|NCT02934347|P1|Participant Flow|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
624246|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
624247|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
624248|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
624249|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
624250|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
624251|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
624252|NCT02934347|O2|Outcome|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
624253|NCT02934347|O1|Outcome|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
624254|NCT02934347|E2|Reported Event|Back-up|A subsequent group of similar the patients who had their anaesthesia induced and tracheas intubated in a 25 degree back-up position achieved by flexion of the operating table at the hips
624255|NCT02934347|E1|Reported Event|Supine|A baseline group of adult patients who required intubation as part of their routine anaesthesia who were intubated in the standard horizontal sniffing position.
624256|NCT02920749|B5|Baseline|Total|Total of all reporting groups
624257|NCT02920749|B4|Baseline|Group D|Anaesthesia was maintained with propofol and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
624258|NCT02920749|B3|Baseline|Group C|General anaesthesia was maintained with propofol.
624259|NCT02920749|B2|Baseline|Group B|Anaesthesia was maintained with sevoflurane and the depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too.
624260|NCT02920749|B1|Baseline|Group A|General anaesthesia was maintained with sevoflurane.
624261|NCT02920749|P4|Participant Flow|Group D|In this group anaesthesia was maintained with propofol. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Propofol and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
624262|NCT02920749|P3|Participant Flow|Group C|Anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol and fentanyl dosing was adjusted for the same MAP range. Atracurium was administered at regular intervals.
624263|NCT02920749|P2|Participant Flow|Group B|In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. The depth of anaesthesia (BIS® Quatro Brain Monitoring Sensor, Covidien) and the neuromuscular blocking status (Infinity®, Trident® NMT SmartPod®, Dräger Medical) was monitored too. Sevoflurane and fentanyl dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg. Neuromuscular blocking was maintained with a TOF monitor at the level of one or no response.
624264|NCT02920749|P1|Participant Flow|Group A|Anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane and fentanyl dosing was adjusted for the same MAP range for controlled hypotension within 60-85 mmHg. Atracurium was administered at regular intervals.
624265|NCT02920749|O4|Outcome|Group D|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
624266|NCT02920749|O3|Outcome|Group C|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with propofol 1%, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
624267|NCT02920749|O2|Outcome|Group B|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros. In this group BIS sensor and TOF monitoring was used."
629825|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
624268|NCT02920749|O1|Outcome|Group A|"Drugs at induction were: fentanyl, propofol 1%, atracurium. Anaesthesia was maintained with sevoflurane, fentanyl and atracurium.~Cost was calculated in euros/1 hour. Disposable cost was calculated in euros."
624269|NCT02920749|O4|Outcome|Group D|Fentanyl consumption was studied during total intravenous anaesthesia with BIS and TOF monitoring. It was registered in milligram.
624270|NCT02920749|O3|Outcome|Group C|Fentanyl consumption was studied during total intravenous anaesthesia. It was registered in milligram.
624271|NCT02920749|O2|Outcome|Group B|Fentanyl consumption was studied during sevoflurane anaesthesia with BIS and TOF monitoring. It was registered in milligram.
624272|NCT02920749|O1|Outcome|Group A|Fentanyl consumption was studied during sevoflurane anaesthesia. It was registered in milligram.
624273|NCT02920749|E4|Reported Event|Group D|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
624274|NCT02920749|E3|Reported Event|Group C|During anaesthesia TIVA was applied with a protocol (6 to 8 mg/kg/h propofol). Fentanyl consumption was studied during anaesthesia. It was registered in milligram.
624275|NCT02920749|E2|Reported Event|Group B|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
624276|NCT02920749|E1|Reported Event|Group A|"Anaesthesia was maintained with sevoflurane (1-2% end-tidal concentration, MAC 1.0-1.5) in 50% air and 50% oxygen mixture.~Fentanyl consumption was studied during anaesthesia. It was registered in milligram."
624277|NCT02919657|B1|Baseline|All Participants|All participants were given a baseline blood analysis
624278|NCT02919657|P2|Participant Flow|Whey Protein Isolate Then Genepro Gen2 Protein|"30g Serving of Whey Isolate Protein will be used daily in each subject.~1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject."
624279|NCT02919657|P1|Participant Flow|Genepro Gen2 Protein Then Whey Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~30g Serving of Whey Isolate Protein will be used daily in each subject."
624280|NCT02919657|O2|Outcome|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
624281|NCT02919657|O1|Outcome|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
624282|NCT02919657|E2|Reported Event|Whey Protein Isolate|"30g Serving of Whey Isolate Protein will be used daily in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Whey Protein: weekly blood draws to measure blood protein levels"
624283|NCT02919657|E1|Reported Event|Genepro Gen2 Protein|"1 tablespoon Serving of Genepro Gen2 Protein daily will be used in each subject.~Intervention: Weekly blood draws will determine the effect on blood protein levels.~Genepro Protein: weekly blood draws to measure blood protein levels"
624284|NCT02903238|B1|Baseline|Placebo|"placebo capsule~placebo: lactose containing capsule"
624285|NCT02903238|P1|Participant Flow|Placebo|"placebo capsule~placebo: lactose containing capsule"
624286|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule~placebo: lactose containing capsule"
624287|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule~placebo: lactose containing capsule"
624288|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule~placebo: lactose containing capsule"
624289|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule~placebo: lactose containing capsule"
624290|NCT02903238|O2|Outcome|Placebo Non-responders|"placebo capsule~placebo: lactose containing capsule"
624291|NCT02903238|O1|Outcome|Placebo Responders|"placebo capsule~placebo: lactose containing capsule"
624292|NCT02903238|E1|Reported Event|Placebo|"placebo capsule~placebo: lactose containing capsule"
624293|NCT02895347|B3|Baseline|Total|Total of all reporting groups
624294|NCT02895347|B2|Baseline|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
624295|NCT02895347|B1|Baseline|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
624296|NCT02895347|P2|Participant Flow|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
624297|NCT02895347|P1|Participant Flow|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
624298|NCT02895347|O1|Outcome|Experimental Group|"Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then they were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until they reached proficiency (91%) in all 4 activities. 4. Participants were asked to return where they were filmed and timed completing a suturing activity on the porcine model.~Surgical Simulation Practice Modules: The surgical simulation practice modules simulate surgical settings for suturing."
624359|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624360|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624299|NCT02895347|O2|Outcome|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
624300|NCT02895347|O1|Outcome|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
624301|NCT02895347|O2|Outcome|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
624302|NCT02895347|O1|Outcome|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
624303|NCT02895347|E2|Reported Event|Experimental Group|Participants in the Experimental Group (EG) were asked to attend an orientation reviewing the study. Then participants were instructed to complete 4 activities on the dvSS ® that modeled suturing techniques in minimally invasive robotics-assisted surgery. EG participants repeated these 4 activities over a period of 2 weeks until proficiency (91%) in all 4 activities was reached. Participants were asked to return and were filmed and timed completing a suturing activity on the porcine model.
624304|NCT02895347|E1|Reported Event|Control Group|Participants in the Control Group (CG) were asked to attend an orientation reviewing the study. Three weeks later participants returned and were filmed timed completing a suturing activity on the porcine model.
624305|NCT02889289|B1|Baseline|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624306|NCT02889289|P1|Participant Flow|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624307|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624308|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624309|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624310|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624361|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624362|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624311|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624312|NCT02889289|O1|Outcome|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624313|NCT02889289|E1|Reported Event|Xbox One Kinect Gaming|"15 sessions of supervised physical therapy using 2 commercially available Xbox One Kinect game.~Xbox One Kinect Gaming: The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called “Shape Up” and “Kinect Sports: Rivals” to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant’s abilities."
624314|NCT02882152|B3|Baseline|Total|Total of all reporting groups
624315|NCT02882152|B2|Baseline|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
624316|NCT02882152|B1|Baseline|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
624317|NCT02882152|P2|Participant Flow|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
624318|NCT02882152|P1|Participant Flow|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
624319|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
624320|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
624321|NCT02882152|O2|Outcome|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
624322|NCT02882152|O1|Outcome|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
624323|NCT02882152|E2|Reported Event|Morphine|"intrathecal morphine~morphine: Intrathecal morphine injection"
624324|NCT02882152|E1|Reported Event|Femoral Blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve~femoral nerve blockade: femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
624325|NCT02863198|B3|Baseline|Total|Total of all reporting groups
624326|NCT02863198|B2|Baseline|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624327|NCT02863198|B1|Baseline|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624328|NCT02863198|P2|Participant Flow|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624329|NCT02863198|P1|Participant Flow|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624330|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624331|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624332|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624333|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624334|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624335|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624336|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624337|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624338|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624339|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624340|NCT02863198|O2|Outcome|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624341|NCT02863198|O1|Outcome|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624342|NCT02863198|E2|Reported Event|Non Endometrial Injury|non endometrial injury was done only for patient of the control group
624343|NCT02863198|E1|Reported Event|Endometrial Injury|"Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle).~endometrial injury: Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10–15 mm from the fundus using pipelle endometrial sampling (Pipelle)."
624344|NCT02862106|B7|Baseline|Total|Total of all reporting groups
624345|NCT02862106|B6|Baseline|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624346|NCT02862106|B5|Baseline|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624347|NCT02862106|B4|Baseline|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624348|NCT02862106|B3|Baseline|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624349|NCT02862106|B2|Baseline|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624350|NCT02862106|B1|Baseline|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624351|NCT02862106|P2|Participant Flow|Follow-up Group|Do not give any intervention, follow-up observation only
624352|NCT02862106|P1|Participant Flow|εPA-44 900μg|"Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128~εPA-44: Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128"
624353|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624354|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624355|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624356|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624357|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624365|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624366|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624367|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624368|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624369|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624370|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624371|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624372|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624373|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624374|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624375|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624376|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624377|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624378|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624379|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624380|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624381|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624382|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624383|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624384|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from theεPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624385|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624386|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624387|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624388|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624389|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624390|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624391|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624392|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624393|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624394|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624395|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624396|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624397|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the placebo group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624398|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624399|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624400|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
626662|NCT02684942|O1|Outcome|Meperidine|Separate analysis in meperidine group.
624401|NCT02862106|O6|Outcome|εPA-44 900μg Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624402|NCT02862106|O5|Outcome|εPA-44 900μg Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624403|NCT02862106|O4|Outcome|εPA-44 900μg Group-placebo|These subjects from the εPA-44 600μg group of protocol 71006.01 Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
624404|NCT02862106|O3|Outcome|Follow-up Group-εPA-44 900μg|These subjects from the εPA-44 900μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624405|NCT02862106|O2|Outcome|Follow-up Group-εPA-44 600μg|These subjects from the εPA-44 600μg group of protocol 71006.01 Do not give any intervention, follow-up observation only
624406|NCT02862106|O1|Outcome|Follow-up Group-placebo|These subjects from the placebo group of protocol 71006.01 Do not give any intervention, follow-up observation only
624407|NCT02862106|E2|Reported Event|εPA-44 900μg Group|Inject εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128 All safety analyzes were analyzed in a safe population, and since 5 subjects had no safety data, they were excluded from the safety population
624408|NCT02862106|E1|Reported Event|Follow-up Group|Do not give any intervention, follow-up observation only All safety analyzes were analyzed in a safe population, and since 1 subjects had no safety data, they were excluded from the safety population
624409|NCT02856880|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline evaluation.
624410|NCT02856880|P1|Participant Flow|Overall Study|This was a single-centre, analyst and examiner (plaque sample collector)-blind, randomized, five-treatment, five-period, cross-over study in healthy adult participants. Each participant received each of the five interventions i.e., Test Zinc-isopropylmethylphenol (IPMP), Test Zinc non-IPMP, Positive control, non-sodium lauryl sulphate (SLS) negative control, SLS negative control.
624411|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624412|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624413|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
624414|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624415|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624416|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624417|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624418|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
624419|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624420|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624421|NCT02856880|O5|Outcome|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150ppm fluoride as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624422|NCT02856880|O4|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624423|NCT02856880|O3|Outcome|Positive Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100ppm F as stannous fluoride) in 10mL water for 60 sec followed by rinse with 10mL water
624424|NCT02856880|O2|Outcome|Test Zinc Non- IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624425|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm F as sodium fluoride in 10mL water for 60 sec followed by rinse with 10mL water
624426|NCT02856880|O2|Outcome|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624427|NCT02856880|O1|Outcome|Test Zinc-IPMP|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
624428|NCT02856880|E5|Reported Event|SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
625061|NCT02796092|E2|Reported Event|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
624429|NCT02856880|E4|Reported Event|Non-SLS Negative Control|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624430|NCT02856880|E3|Reported Event|Positive Control Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.454% w/w stannous fluoride (1100 ppm F as stannous fluoride) in 10 mL water for 60 sec followed by rinse with 10 mL water
624431|NCT02856880|E2|Reported Event|Test Zinc Non- IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624432|NCT02856880|E1|Reported Event|Test Zinc-IPMP Toothpaste|Participants were instructed to rinse their mouth with prepared slurry of toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426 ppm F as sodium fluoride in 10 mL water for 60 sec followed by rinse with 10 mL water
624433|NCT02849678|B3|Baseline|Total|Total of all reporting groups
624434|NCT02849678|B2|Baseline|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
624435|NCT02849678|B1|Baseline|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
624436|NCT02849678|P2|Participant Flow|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
624437|NCT02849678|P1|Participant Flow|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
624438|NCT02849678|O2|Outcome|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
624439|NCT02849678|O1|Outcome|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
624440|NCT02849678|E2|Reported Event|Ropivacaine|"Ropivacaine is a local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.~Ropivacaine has been safely used in the paravertebral nerve blocks at our institution for several years.~Ropivacaine: 0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared."
625274|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
624441|NCT02849678|E1|Reported Event|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia.Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use.~Lidocaine: Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
624442|NCT02847169|B1|Baseline|Overall Participants|"Participants are randomized to wear filcon IV1 or ocufilcon D toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
624443|NCT02847169|P2|Participant Flow|Ocufilcon D Toric Lens, Then Filcon IV1 Toric Lens|"Participants are randomized to wear ocufilcon D toric lens, then filcon IV1 lens pair for 1 week each during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
624444|NCT02847169|P1|Participant Flow|Filcon IV1 Toric Lens, Then Ocufilcon D Toric Lens|"Participants are randomized to wear filcon IV1 toric lens, then ocufilcon D toric lens pair for 1 week each during the cross over study.~filcon IV1: toric contact lens~ocufilcon D: toric contact lens"
624445|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
624446|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
624447|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
624448|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
624449|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was gathered at baseline.
624450|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
624451|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
624452|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
624453|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
624454|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was gathered at baseline.
624455|NCT02847169|O2|Outcome|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
624456|NCT02847169|O1|Outcome|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
624457|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|Data collected at 1 week for ocufilcon D toric lens.
624458|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|Data collected at 1 week for filcon IV1 toric lens.
624459|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|Data collected at baseline for ocufilcon D toric lens.
624460|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|Data collected at baseline for filcon IV1 toric lens.
624461|NCT02847169|O1|Outcome|Habitual Toric Lens|Habitual data was assessed at baseline.
624462|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
624463|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
624464|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
624465|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
624466|NCT02847169|O1|Outcome|Habitual Lens (Baseline)|Habitual lens assessed at baseline.
624467|NCT02847169|O3|Outcome|Substantially Decentered|Lens centration
624468|NCT02847169|O2|Outcome|Decentered Slightly|Lens centration
624469|NCT02847169|O1|Outcome|Optimal Centration|Lens centration
624470|NCT02847169|O5|Outcome|Ocufilcon D Toric Lens (1 Week)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
624471|NCT02847169|O4|Outcome|Filcon IV1 Toric Lens (1 Week)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
624472|NCT02847169|O3|Outcome|Ocufilcon D Toric Lens (Baseline)|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D: toric contact lens"
624473|NCT02847169|O2|Outcome|Filcon IV1 Toric Lens (Baseline)|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1: toric contact lens"
624474|NCT02847169|O1|Outcome|Habitual Lens (Baseline)|Habitual data was assessed at baseline.
624475|NCT02847169|E2|Reported Event|Ocufilcon D Toric Lens|"Participants are randomized to wear ocufilcon D toric lens pair for 1 week during the cross over study.~ocufilcon D toric lens: toric contact lens"
624476|NCT02847169|E1|Reported Event|Filcon IV1 Toric Lens|"Participants are randomized to wear filcon IV1 toric lens pair for 1 week during the cross over study.~filcon IV1 toric lens: toric contact lens"
624477|NCT02840916|B3|Baseline|Total|Total of all reporting groups
624478|NCT02840916|B2|Baseline|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
624479|NCT02840916|B1|Baseline|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
624480|NCT02840916|P2|Participant Flow|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
624481|NCT02840916|P1|Participant Flow|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
624482|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
624483|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
624484|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
624485|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
624486|NCT02840916|O2|Outcome|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
624487|NCT02840916|O1|Outcome|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
624488|NCT02840916|E2|Reported Event|Sham Laser Acupuncture|"sham laser acupuncture (no laser output)~sham laser acupuncture: Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group."
624489|NCT02840916|E1|Reported Event|Verum Laser Acupuncture|"verum laser acupuncture~laser acupuncture: Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total."
624490|NCT02839772|B3|Baseline|Total|Total of all reporting groups
624491|NCT02839772|B2|Baseline|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
624492|NCT02839772|B1|Baseline|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
624493|NCT02839772|P2|Participant Flow|Current Skin Regimen Plus 2% Glycerine|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
624494|NCT02839772|P1|Participant Flow|Current Skin Care Regimen|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
624495|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624496|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624497|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624498|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624499|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624500|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
625501|NCT02750345|B1|Baseline|All Study Participants|Grouped by all participants as this is how overall data has been collected.
624501|NCT02839772|O1|Outcome|Correlation Between Number of Wounds and Days Lost Due to ADL|Correlation between nuumber of work days lost in previous month due to ADL and number of wounds (all skin breaches including areas of fungal infection)
624502|NCT02839772|O2|Outcome|Number of Days Lost by All Participants at 4th Visit|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624503|NCT02839772|O1|Outcome|Number of Days Work Days Lost by All Participants Baseline|Number of days work lost in previous month due to adeno-lymphangitis. Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624504|NCT02839772|O2|Outcome|Number of Wounds 4th Visit|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at 4th visit.
624505|NCT02839772|O1|Outcome|Number of Wounds at Baseline|The total number of wounds (skin breaches including areas of fungal infection) of all participants on all legs/feet at baseline.
624506|NCT02839772|O2|Outcome|Participants With Bad Odour From Legs/Feet at 4th Visit|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
624507|NCT02839772|O1|Outcome|Participants With Bad Odour From Legs/Feet at Baseline|Presence of a bad odour emanating from legs/feet of all participants as determined by clinic nurse.
624508|NCT02839772|O2|Outcome|Total Number of Trophic Skin Changes at 4th Visit|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported. A reduction in the number of legs/feet with mossy changes would denote an improvement in the condition.
624509|NCT02839772|O1|Outcome|Total Number of Trophic Skin Changes at Baseline|Trophic (mossy) skin changes on the lower legs/feet are a characteristic of podoconiosis. The total number of all participants with trophic changes in their lower legs/feet is reported.
624510|NCT02839772|O2|Outcome|Stage of Podoconiosis 4th Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
624511|NCT02839772|O1|Outcome|Stage of Podoconiosis 1st Visit|The number of legs with each stage of podoconiosis (1-5) and those with no disease
624512|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624513|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624514|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624515|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624516|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624517|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624518|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624519|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624520|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624521|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624522|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624523|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624524|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624682|NCT02813070|B3|Baseline|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624525|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624526|NCT02839772|O2|Outcome|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and 2% glycerine and frequently splashed up legs, air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624527|NCT02839772|O1|Outcome|Control Group|Legs/feet washed daily for 3 months with soapy water, soak for 30 mins in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%), air dried, thin layer of petrolatum jelly applied. Whitfields ointment applied if required to any area of fungal infection.
624528|NCT02839772|E2|Reported Event|Experimental Group|Legs/feet washed daily for 3 months with soapy water, soaked in 1 litre of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
624529|NCT02839772|E1|Reported Event|Control Group|Legs/feet washed daily for 3 months with soapy water, soaked in 6 litres of water with added sodium hypochlorite (NaOCI) (0.0125%) and splashed up the lower legs with the hands for 30 mins, then air dried, a thin layer of petrolatum jelly applied. Whitfields ointment was applied if required to any areas of fungal infection.
624530|NCT02834624|B3|Baseline|Total|Total of all reporting groups
624531|NCT02834624|B2|Baseline|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624532|NCT02834624|B1|Baseline|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624533|NCT02834624|P2|Participant Flow|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624534|NCT02834624|P1|Participant Flow|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624535|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624536|NCT02834624|O1|Outcome|Poractant|Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624537|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624538|NCT02834624|O1|Outcome|Poractant|Randomized to receive poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624539|NCT02834624|O2|Outcome|Calfactant|Randomized to receive calfactant (Infasurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624540|NCT02834624|O1|Outcome|Poractant|Randomized to receive Poractant alfa (Curosurf) as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
624541|NCT02834624|E2|Reported Event|Poractant Alfa|"Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.~Poractant alfa: Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist."
624542|NCT02834624|E1|Reported Event|Calfactant|"Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.~calfactant: Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist"
624543|NCT02832375|B3|Baseline|Total|Total of all reporting groups
624544|NCT02832375|B2|Baseline|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624545|NCT02832375|B1|Baseline|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624546|NCT02832375|P2|Participant Flow|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624547|NCT02832375|P1|Participant Flow|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% weight by weight (w/w) of SnF (1100 parts per million [ppm] fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624548|NCT02832375|O2|Outcome|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624683|NCT02813070|B2|Baseline|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624549|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624550|NCT02832375|O2|Outcome|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624551|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624552|NCT02832375|O2|Outcome|Control: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624553|NCT02832375|O1|Outcome|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624554|NCT02832375|E2|Reported Event|Standard: Sodium Monofluorophosphate(SMFP)|Participants were instructed to dose a dry toothbrush containing 0.76% w/w SMFP (1000ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed their whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624555|NCT02832375|E1|Reported Event|Experimental: Stannous Fluoride(SnF)|Participants were instructed to dose a dry toothbrush containing 0.454% w/w of SnF (1100ppm fluoride) with a full strip (1 inch) of toothpaste. Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
624556|NCT02829775|B1|Baseline|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
624557|NCT02829775|P1|Participant Flow|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
624558|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study will continue to receive the same treatment in this study. Pegylated interferon alfa-2A will be administered subcutaneously once weekly and recombinant interferon alfa 2A will be administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
624559|NCT02829775|O1|Outcome|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
624560|NCT02829775|E1|Reported Event|Interferon Alfa-2A in Cancer Participants|Participants who responded to interferon alfa-2A (either pegylated interferon alfa-2A or recombinant interferon alfa 2A) treatment during the parent study continued to receive the same treatment in this study. Pegylated interferon alfa-2A was administered subcutaneously once weekly and recombinant interferon alfa 2A was administered subcutaneously once daily, until disease progression, withdrawal, or death whichever occurred first (up to approximately 3 years).
624561|NCT02829463|B3|Baseline|Total|Total of all reporting groups
624562|NCT02829463|B2|Baseline|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624563|NCT02829463|B1|Baseline|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624564|NCT02829463|P2|Participant Flow|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624565|NCT02829463|P1|Participant Flow|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624566|NCT02829463|O2|Outcome|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624567|NCT02829463|O1|Outcome|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624568|NCT02829463|E2|Reported Event|Healthy Controls|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients without osteoarthritis. It's not the intervention the study applied, but the subjects' non-osteoarthritis knee symptom demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624569|NCT02829463|E1|Reported Event|Osteoarthritis Patients|"3.0 Tesla Magnetic resonance imaging was analyzed. It's the documentation from the outpatients and inpatients with osteoarthritis. It's not the intervention the study applied, but the subjects' disease demands.~Magnetic resonance imaging: 3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects."
624570|NCT02828137|B4|Baseline|Total|Total of all reporting groups
624571|NCT02828137|B3|Baseline|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
624572|NCT02828137|B2|Baseline|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
624573|NCT02828137|B1|Baseline|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
624574|NCT02828137|P3|Participant Flow|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
624575|NCT02828137|P2|Participant Flow|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
624576|NCT02828137|P1|Participant Flow|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
624577|NCT02828137|O3|Outcome|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90 IMR 32.95 ± 20.60
624578|NCT02828137|O2|Outcome|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90 IMR 23.22 ± 12.73
624579|NCT02828137|O1|Outcome|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78 IMR 21.94 ± 12.87
624580|NCT02828137|E3|Reported Event|High NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio > 3.90
624581|NCT02828137|E2|Reported Event|Intermediate NLR Group|1.78 < Neutrophil-to-Lymphocyte (NLR) Ratio < 3.90
624582|NCT02828137|E1|Reported Event|Low NLR Group|Neutrophil-to-Lymphocyte (NLR) Ratio < 1.78
624583|NCT02823080|B3|Baseline|Total|Total of all reporting groups
624584|NCT02823080|B2|Baseline|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624585|NCT02823080|B1|Baseline|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624586|NCT02823080|P2|Participant Flow|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624587|NCT02823080|P1|Participant Flow|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD(maximal ovarian diameter) were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624588|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624589|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624590|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624591|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624592|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624593|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624594|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624595|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624596|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
626663|NCT02684942|E2|Reported Event|Fentanyl|Analyze in fentanyl group.
624597|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-days Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624598|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624599|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624600|NCT02823080|O2|Outcome|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624601|NCT02823080|O1|Outcome|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624602|NCT02823080|E2|Reported Event|no Cetrotide|control group (24 patients) did not receive 3-daysCetrorelix Acetate (no intervention). Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624603|NCT02823080|E1|Reported Event|Cetrotide|study group (24 patients = intervention) received intervention for 3-daysCetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites grading were re-evaluated on Day-3, 6 and 8.
624604|NCT02822885|B1|Baseline|Ultrasonography|"Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries~Ultrasonography: Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries"
624605|NCT02822885|P1|Participant Flow|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
624606|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
624607|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
624608|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
624609|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
624610|NCT02822885|O1|Outcome|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
624611|NCT02822885|E1|Reported Event|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
624612|NCT02822287|B1|Baseline|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624613|NCT02822287|P1|Participant Flow|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624614|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624615|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624616|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624617|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624618|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624619|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624620|NCT02822287|O1|Outcome|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624621|NCT02822287|E1|Reported Event|2% Acetylcystine Solution|Participants received a single dose of 200 mg (10 mL) of Acetylcysteine 2% oral solution.
624622|NCT02821403|B3|Baseline|Total|Total of all reporting groups
624623|NCT02821403|B2|Baseline|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
624684|NCT02813070|B1|Baseline|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
629826|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
624624|NCT02821403|B1|Baseline|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
624625|NCT02821403|P2|Participant Flow|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624626|NCT02821403|P1|Participant Flow|Young Adults|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~Cross-over study design: The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624627|NCT02821403|O2|Outcome|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
624628|NCT02821403|O1|Outcome|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
624629|NCT02821403|O6|Outcome|Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624630|NCT02821403|O5|Outcome|Middle-aged Adults: Regular Coating Lens With Yellow Tint|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624631|NCT02821403|O4|Outcome|Middle-aged Adults: Clear Lens With Regular Coating|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624632|NCT02821403|O3|Outcome|Young Adults: Clear Lens With Blue-light Blocking Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624633|NCT02821403|O2|Outcome|Young Adults: Regular Coating Lens With Yellow Tint|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624634|NCT02821403|O1|Outcome|Young Adults: Clear Lens With Regular Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624635|NCT02821403|O6|Outcome|Middle-aged Adults: Clear Lens With Blue-light Blocking Coatin|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624636|NCT02821403|O5|Outcome|Middle-aged Adults: Regular Coating Lens With Yellow Tint|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624637|NCT02821403|O4|Outcome|Middle-aged Adults: Clear Lens With Regular Coating|"adults with presbyopia who aged over 40 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624638|NCT02821403|O3|Outcome|Young Adults: Clear Lens With Blue-light Blocking Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624639|NCT02821403|O2|Outcome|Young Adults: Regular Coating Lens With Yellow Tint|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624640|NCT02821403|O1|Outcome|Young Adults: Clear Lens With Regular Coating|"adults without presbyopia who aged 18-35 years~Three types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating.~The sequence of lens types was pseudo-randomized for each individual, i.e., participants were allocated in different sequences of lens wear by the date of admission."
624641|NCT02821403|E2|Reported Event|Middle-aged Adults|"adults with presbyopia who aged over 40 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
624642|NCT02821403|E1|Reported Event|Young Adults|"adults without presbyopia who aged 18-35 years~Three spectacle lens designs: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating: 3 types of spectacle lenses were given to all participants: 1) clear lens with regular coating; 2) regular coating lens with yellow tint; 3) clear lens with blue-light blocking coating"
624643|NCT02817763|B3|Baseline|Total|Total of all reporting groups
624644|NCT02817763|B2|Baseline|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624645|NCT02817763|B1|Baseline|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624646|NCT02817763|P2|Participant Flow|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624647|NCT02817763|P1|Participant Flow|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624648|NCT02817763|O2|Outcome|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624649|NCT02817763|O1|Outcome|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624650|NCT02817763|O2|Outcome|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624685|NCT02813070|P3|Participant Flow|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624651|NCT02817763|O1|Outcome|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624652|NCT02817763|E2|Reported Event|CTG Plus Resin Composite Restoration|"After local anesthesia, a sterile rubber dam was placed to isolate the operative field and the coronal zone of the non-carious cervical lesion restoration was performed with a nanocomposite resin, following the manufacturer's instructions. The apical margin of the restoration was place 1 millimeter beyond to the cemento-enamel junction estimation. In the next session, the surgical procedure performed was the trapezoidal-type of CAF. After the trapezoidal-type of CAF flap was raised, a thin and small connective tissue graft that was sutured over the restoration surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~CTG plus resin composite restoration: Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624653|NCT02817763|E1|Reported Event|Connective Tissue Graft (CTG)|"After local anesthesia, the surgical procedure performed was the trapezoidal-type of Coronally advanced flap (CAF). After the flap was raised, the exposed root surface was gently scaled and planed until it became smooth. Afterward, a thin and small connective tissue graft that was sutured over the root surface. Then, the flap was coronally positioned and sutured to completely cover the graft.~Connective tissue graft (CTG): Periodontal surgical technique to treat gingival recessions~sodium dipyrone: sodium dipyrone was recommended for all participants after the surgical procedures."
624654|NCT02815735|B1|Baseline|Overall Participants|"Participants wear comfilcon A and lotrafilcon B lens for 4 weeks during the cross over study.~comfilcon A: contact lens~lotrafilcon B: contact lens"
624655|NCT02815735|P2|Participant Flow|Lotrafilcon B, Then Comfilcon A|"Participants wear lotrafilcon B lens, then comfilcon A lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens~comfilcon A: contact lens"
624656|NCT02815735|P1|Participant Flow|Comfilcon A, Then Lotrafilcon B|"Participants wear comfilcon A lens, then lotrafilcon B for 4 weeks during the cross over study.~comfilcon A: contact lens~lotrafilcon B: contact lens"
624657|NCT02815735|O6|Outcome|Lotrafilcon B (Day 26)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
624658|NCT02815735|O5|Outcome|Comfilcon A (Day 26)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
624659|NCT02815735|O4|Outcome|Lotrafilcon B (Day 12)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
624660|NCT02815735|O3|Outcome|Comfilcon A (Day 12)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
624661|NCT02815735|O2|Outcome|Lotrafilcon B (Day 3)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
624662|NCT02815735|O1|Outcome|Comfilcon A (Day 3)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
624663|NCT02815735|O5|Outcome|Lotrafilcon B (4 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
624664|NCT02815735|O4|Outcome|Comfilcon A (4 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
624665|NCT02815735|O3|Outcome|Lotrafilcon B (2 Weeks)|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
624666|NCT02815735|O2|Outcome|Comfilcon A (2 Weeks)|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
624667|NCT02815735|O1|Outcome|Habitual (Baseline)|Habitual data assessed at baseline.
624668|NCT02815735|E2|Reported Event|Lotrafilcon B|"Participants wear lotrafilcon B lens for 4 weeks during the cross over study.~lotrafilcon B: contact lens"
624669|NCT02815735|E1|Reported Event|Comfilcon A|"Participants wear comfilcon A lens for 4 weeks during the cross over study.~comfilcon A: contact lens"
624670|NCT02814279|B3|Baseline|Total|Total of all reporting groups
624671|NCT02814279|B2|Baseline|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624672|NCT02814279|B1|Baseline|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624686|NCT02813070|P2|Participant Flow|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of amnestic mild cognitive impairment (aMCI), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624831|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
624673|NCT02814279|P2|Participant Flow|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624674|NCT02814279|P1|Participant Flow|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624675|NCT02814279|O2|Outcome|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624676|NCT02814279|O1|Outcome|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624677|NCT02814279|O2|Outcome|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624678|NCT02814279|O1|Outcome|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624679|NCT02814279|E2|Reported Event|Tunnel Plus Connective Tissue Graft|"The tunnel flap was performed according to Zuhr et al., 2007. Following initial sulcular incisions, spit thickness flap was prepared using specific tunneling knives beyond the mucogingival junction and until flap gain mobility. The flap was laterally extended to adjacent papillae that were carefully detached by means of a full-thickness preparation. The connective tissue graft was insert into the tunnel. Sling sutures were performed involving the flap and graft to coronally cover 2 mm above the CEJ.~Tunnel plus connective tissue graft: Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624680|NCT02814279|E1|Reported Event|CAF Plus Connective Tissue Graft|"CAF treatment was performed by starting with two divergent releasing incisions lateral to the recessed area. A sulcular incision was made to unite the releasing incisions and the flap was raised beyond the mucogingival junction (MGJ) in split-full-split thickness. The connective tissue graft was removed from the palate according to Bruno technique (1994) and sutured in position. Sling sutures were placed to stabilize the flap in a coronal position 2 mm above the CEJ, followed by interrupted sutures to close the releasing incisions.~CAF plus connective tissue graft: Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.~Sodium dipyrone: All participants were instructed to take 500 mg sodium dipyrone just in case of pain.~chlorhexidine rinse: All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures."
624681|NCT02813070|B4|Baseline|Total|Total of all reporting groups
625383|NCT02753699|P1|Participant Flow|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
624687|NCT02813070|P1|Participant Flow|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of probable Alzheimer's disease (pAD), received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent Positron emission tomography (PET) imaging.
624688|NCT02813070|O2|Outcome|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624689|NCT02813070|O1|Outcome|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624690|NCT02813070|O2|Outcome|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624691|NCT02813070|O1|Outcome|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624692|NCT02813070|E3|Reported Event|Healthy Volunteers|Healthy Volunteers at baseline, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624693|NCT02813070|E2|Reported Event|Participants With Amnestic Mild Cognitive Impairment|Participants with baseline diagnosis of aMCI, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624694|NCT02813070|E1|Reported Event|Participants With Probable Alzheimer's Disease|Participants with baseline diagnosis of pAD, received a single intravenous administration of Flutemetamol F 18 injection. Ninety minutes post-injection, participants underwent PET imaging.
624695|NCT02809911|B3|Baseline|Total|Total of all reporting groups
624696|NCT02809911|B2|Baseline|Active Provant|"Active Provant Treatment~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
624697|NCT02809911|B1|Baseline|Sham of Provant|"Sham of Provant Therapy System~Due to an error in the randomization for this study, results are based upon data only for the Initial Treatment population (those subjects treated with either active or sham at the Enrollment Visit). Data from the cross-over was not included since the majority of subjects were not crossed-over to the other treatment."
624698|NCT02809911|P2|Participant Flow|Active Provant|"Active Provant Treatment~Provant"
624699|NCT02809911|P1|Participant Flow|Sham of Provant|"Sham of Provant Therapy System~Provant"
624700|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment~Provant"
624701|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System~Provant"
624702|NCT02809911|O2|Outcome|Active Provant|"Active Provant Treatment~Provant"
624703|NCT02809911|O1|Outcome|Sham of Provant|"Sham of Provant Therapy System~Provant"
624704|NCT02809911|E2|Reported Event|Active Provant|"Active Provant Treatment~Provant"
624705|NCT02809911|E1|Reported Event|Sham of Provant|"Sham of Provant Therapy System~Provant"
624706|NCT02809833|B1|Baseline|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624707|NCT02809833|P1|Participant Flow|Tocilizumab for Rheumatoid Arthritis (RA) in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to the Summary of Product Characteristics (SmPC) were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
624708|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624709|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624710|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624711|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624712|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624713|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
625736|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
624714|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624715|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624716|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624717|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624718|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624719|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624720|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624721|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624722|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624723|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624724|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624725|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624726|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624727|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624728|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624729|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624730|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624731|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624732|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624733|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624734|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624735|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624736|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624737|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624738|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624739|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624740|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624741|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624742|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624743|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624744|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624745|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624746|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624747|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624748|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624749|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624750|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624751|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624752|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624753|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624754|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624755|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624756|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624757|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624758|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624759|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624760|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624761|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624762|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624763|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624764|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624765|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624766|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624767|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624768|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624769|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624770|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624771|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624772|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624773|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624774|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624775|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624776|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624777|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624778|NCT02809833|O1|Outcome|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624779|NCT02809833|E1|Reported Event|Tocilizumab for RA in Routine Practice|Participants from routine clinical practice in Germany who received tocilizumab for RA according to SmPC were observed for up to 12 months. Tocilizumab must have been selected by the treating physician in advance of the study and was not provided by the Sponsor. According to SmPC, tocilizumab was given as 8 mg/kg via IV infusion at 4-week intervals.
624780|NCT02808130|B7|Baseline|Total|Total of all reporting groups
624781|NCT02808130|B6|Baseline|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624782|NCT02808130|B5|Baseline|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624829|NCT02806505|P2|Participant Flow|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
624830|NCT02806505|P1|Participant Flow|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
624783|NCT02808130|B4|Baseline|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624784|NCT02808130|B3|Baseline|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624785|NCT02808130|B2|Baseline|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624786|NCT02808130|B1|Baseline|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624787|NCT02808130|P6|Participant Flow|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624788|NCT02808130|P5|Participant Flow|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624789|NCT02808130|P4|Participant Flow|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624790|NCT02808130|P3|Participant Flow|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624791|NCT02808130|P2|Participant Flow|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
625384|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
624792|NCT02808130|P1|Participant Flow|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624793|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624794|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624795|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624796|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624797|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624798|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624799|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624800|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624801|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624802|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624803|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624804|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624805|NCT02808130|O6|Outcome|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624806|NCT02808130|O5|Outcome|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624807|NCT02808130|O4|Outcome|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic lipid profile and the following cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624808|NCT02808130|O3|Outcome|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624809|NCT02808130|O2|Outcome|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
625737|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
624810|NCT02808130|O1|Outcome|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624811|NCT02808130|E6|Reported Event|Group HCP|"Group HCP: hyperlipidemic + generalized chronic periodontitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624812|NCT02808130|E5|Reported Event|Group HG|"Group HG: hyperlipidemic + gingivitis individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624813|NCT02808130|E4|Reported Event|Group HH|"Group HH: hyperlipidemic + periodontally healthy individuals Hyperlipidemic cut-off values were used according to the laboratory’s recommendation: TC>200mg/dl; TG>200mg/dl; LDL cholesterol >130 mg/dl; HDL <35mg/dl) (29). The diagnosis of the hyperlipidemia had been made at least 3 months before the study, and no distinction was drawn among the hyperlipidemia types. The samples were obtained after a 12-h fasting period from an antecubital vein.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624814|NCT02808130|E3|Reported Event|Group CP|"Group CP: normolipidemic + generalized chronic periodontitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624815|NCT02808130|E2|Reported Event|Group G|"Group G: normolipidemic + gingivitis individuals the healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624816|NCT02808130|E1|Reported Event|Group H|"Group H: normolipidemic+ periodontally healthy individuals The healthy controls were randomly selected from among individuals referred to the Periodontology Department for either dental treatment or check-up.~Periodontal status was assessed by clinical examination and classified according to criteria proposed by the 1999 International World Workshop for a Classification of Periodontal Disease and Conditions.~hyperlipidemia, periodontitis, gingivitis: GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva"
624817|NCT02806544|B1|Baseline|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624818|NCT02806544|P1|Participant Flow|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624819|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624820|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624821|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624822|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624823|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624824|NCT02806544|O1|Outcome|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624825|NCT02806544|E1|Reported Event|Tamoxifen|"Tamoxifen 20mg by mouth daily~Tamoxifen: Tamoxifen 20mg by mouth daily"
624826|NCT02806505|B3|Baseline|Total|Total of all reporting groups
624827|NCT02806505|B2|Baseline|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
624828|NCT02806505|B1|Baseline|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
626664|NCT02684942|E1|Reported Event|Meperidine|Analyze in meperidine group.
624832|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
624833|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
624834|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
624835|NCT02806505|O2|Outcome|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
624836|NCT02806505|O1|Outcome|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
624837|NCT02806505|E2|Reported Event|Peginterferon Alfa-2a 90 mcg|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 90 mcg SC once weekly up to Week 48.
624838|NCT02806505|E1|Reported Event|Peginterferon Alfa-2a 135 Microgram (mcg)|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a 135 mcg subcutaneously (SC) once weekly up to Week 48.
624839|NCT02805907|B3|Baseline|Total|Total of all reporting groups
624840|NCT02805907|B2|Baseline|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
624841|NCT02805907|B1|Baseline|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
624842|NCT02805907|P2|Participant Flow|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
624843|NCT02805907|P1|Participant Flow|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
624844|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
624845|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
624846|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
624847|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
624848|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
624849|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
624850|NCT02805907|O2|Outcome|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
624851|NCT02805907|O1|Outcome|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
624852|NCT02805907|E2|Reported Event|Control Group (CG)|"Placebo in a presentation with an identical appearance taken weekly by the oral route~Placebo"
624853|NCT02805907|E1|Reported Event|Intervention Group (IG)|"Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route~Calcifediol"
624854|NCT02801396|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
624855|NCT02801396|P6|Participant Flow|Control/Test2/Test1|Subjects that received the Control lens during the first period, Test 2 lens during the second period and Test lens 1 during the third period.
624856|NCT02801396|P5|Participant Flow|Control/Test1/Test2|Subjects that received the Control lens during the first period, Test lens 1 during the second period and Test lens 2 during the third period.
624857|NCT02801396|P4|Participant Flow|Test2/Control/Test1|Subjects that received Test lens 2 during the first period, the Control lens during the second and the Test 1 lens during the third period.
624858|NCT02801396|P3|Participant Flow|Test2/Test1/Control|Subjects that received Test lens 2 during the first period, Test lens 1 during the second period and the Control lens during the third period.
624859|NCT02801396|P2|Participant Flow|Test1/Control/Test2|Subjects that received Test lens 1 during the first period, the Control lens during the second period and Test lens 2 during the third period.
624860|NCT02801396|P1|Participant Flow|Test1/Test2/Control|Subjects that received Test lens 1 during the first period, Test lens 2 during the second period and the Control lens during the third period.
624861|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
624862|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
624863|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
624864|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
624865|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
624866|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
624867|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
624868|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
624869|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
624870|NCT02801396|O3|Outcome|Control|Subjects that wore the control lens during any of the 3 study periods.
624871|NCT02801396|O2|Outcome|Test 2|Subjects that wore the Test 2 lens during any of the 3 study periods.
624872|NCT02801396|O1|Outcome|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
624873|NCT02801396|E3|Reported Event|Control|Subjects that wore the control lens during any of the 3 periods.
624874|NCT02801396|E2|Reported Event|Test2|Subjects that wore the Test 2 lens during any of the 3 periods.
624875|NCT02801396|E1|Reported Event|Test1|Subjects that wore the Test 1 lens during any of the 3 study periods.
624876|NCT02799082|B3|Baseline|Total|Total of all reporting groups
624877|NCT02799082|B2|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624878|NCT02799082|B1|Baseline|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624879|NCT02799082|P2|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624880|NCT02799082|P1|Participant Flow|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624881|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624882|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624883|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624884|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624885|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624886|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624887|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624888|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624889|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624890|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624891|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624892|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624893|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624894|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
625054|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
624895|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624896|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624897|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624898|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624899|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624900|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624901|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624902|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624903|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624904|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624905|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624906|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624907|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624908|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624909|NCT02799082|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624910|NCT02799082|O1|Outcome|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624911|NCT02799082|E2|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624912|NCT02799082|E1|Reported Event|Vehicle|"Topical application of matched placebo gel (without containing active ingredient). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1.0 cm surrounding margin.~Vehicle: topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation)."
624913|NCT02799069|B4|Baseline|Total|Total of all reporting groups
625738|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
624914|NCT02799069|B3|Baseline|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624915|NCT02799069|B2|Baseline|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624916|NCT02799069|B1|Baseline|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624917|NCT02799069|P3|Participant Flow|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624918|NCT02799069|P2|Participant Flow|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624919|NCT02799069|P1|Participant Flow|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624920|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624921|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624922|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624923|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624924|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624925|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624926|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624927|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624928|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624929|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624930|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624931|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625055|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
624932|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624933|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624934|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624935|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624936|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624937|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624938|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624939|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624940|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624941|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624942|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624943|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624944|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624945|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624946|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624947|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624948|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624949|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625056|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
624950|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624951|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624952|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624953|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624954|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624955|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624956|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624957|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624958|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624959|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624960|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624961|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624962|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624963|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624964|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624965|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624966|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624967|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625057|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
624968|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624969|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624970|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624971|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624972|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624973|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624974|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624975|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624976|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624977|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624978|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624979|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624980|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624981|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624982|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624983|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624984|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624985|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625058|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
624986|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624987|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624988|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624989|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624990|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624991|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624992|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624993|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624994|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624995|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624996|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624997|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624998|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
624999|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625000|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625001|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625002|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625003|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625059|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625004|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625005|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625006|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625007|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625008|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625009|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625010|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625011|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625012|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625013|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625014|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625015|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625016|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625017|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625018|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625019|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625020|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625021|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625060|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625022|NCT02799069|O3|Outcome|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625023|NCT02799069|O2|Outcome|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625024|NCT02799069|O1|Outcome|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625025|NCT02799069|E3|Reported Event|MAL Cream|"Topical application of MAL cream (Metvix) containing 160 mg/g methyl-aminolevulinate (MAL). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~MAL: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625026|NCT02799069|E2|Reported Event|BF-200 ALA|"Topical application of BF-200 ALA gel containing 78 mg/g 5-aminolevulinic acid (ALA). Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA: topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625027|NCT02799069|E1|Reported Event|Vehicle|"Topical application of BF-200 ALA matched placebo gel without active ingredient. Application of a 1 mm thick layer covering each lesion and a 0.5 cm to 1 cm surrounding margin.~BF-200 ALA matched placebo: topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source."
625028|NCT02796092|B3|Baseline|Total|Total of all reporting groups
625029|NCT02796092|B2|Baseline|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625030|NCT02796092|B1|Baseline|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625031|NCT02796092|P2|Participant Flow|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625032|NCT02796092|P1|Participant Flow|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625033|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625034|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625035|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625036|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625037|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625038|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625039|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625040|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625041|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625042|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625043|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625044|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625045|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625046|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625047|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625048|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625049|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625050|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625051|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
625052|NCT02796092|O1|Outcome|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625053|NCT02796092|O2|Outcome|Vascular Plugs|"Embolization of the pelvic veins with vascular plugs (Amplatzer Vascular Plugs II. St. Jude Medical. St. Paul, MN, USA)~Vascular plugs"
626665|NCT02684630|B3|Baseline|Total|Total of all reporting groups
625062|NCT02796092|E1|Reported Event|Fibered Platinum Coils|"Embolization of the pelvic veins with platinum fibered coils (Nester. Cook Europe, Bjaeverskov, Denmark)~Fibered platinum coils"
625063|NCT02792049|B3|Baseline|Total|Total of all reporting groups
625064|NCT02792049|B2|Baseline|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
625065|NCT02792049|B1|Baseline|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
625066|NCT02792049|P2|Participant Flow|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
625067|NCT02792049|P1|Participant Flow|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
625068|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
625069|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
625070|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
625071|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
625072|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
625073|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
625074|NCT02792049|O2|Outcome|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
625075|NCT02792049|O1|Outcome|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
625076|NCT02792049|O2|Outcome|Conventional Ambu Spur II Bag Valve Mask|A health volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
625077|NCT02792049|O1|Outcome|Modified Ambu Spur II Bag Valve Mask|A health volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model).
625078|NCT02792049|E2|Reported Event|Unmodified Ambu Bag Valve Mask (BVM) First Then Modified BVM|A healthcare provider volunteer uses a conventional Ambu Spur II bag valve mask to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using a modified Ambu Spur II bag valve mask with integrated handle.
625079|NCT02792049|E1|Reported Event|Modified Ambu Bag Valve Mask (BVM) First Then Unmodified BVM|A healthcare provider volunteer uses a modified Ambu Spur II bag valve mask with integrated internal handle (experimental device, not yet FDA approved) to deliver 10 breaths per minute for 3 minutes to a manikin (IngMar RespiTrainer manikin model). The subject then repeats these procedures using an unmodified Ambu bag valve mask.
625080|NCT02791659|B3|Baseline|Total|Total of all reporting groups
625081|NCT02791659|B2|Baseline|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625082|NCT02791659|B1|Baseline|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625113|NCT02788097|B2|Baseline|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
625083|NCT02791659|P2|Participant Flow|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625084|NCT02791659|P1|Participant Flow|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625085|NCT02791659|O2|Outcome|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625086|NCT02791659|O1|Outcome|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625087|NCT02791659|E2|Reported Event|Prone|"In this group, the position will be assigned to Prone during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625088|NCT02791659|E1|Reported Event|Left Lateral Decubitus|"In this group, the position will be assigned to Left lateral decubitus during ERCP. The radiation from fluoroscopy will be adjusted by automatic beam adjustment function to obtain the image quality.~Automatic beam adjustment function: The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output."
625089|NCT02791269|B3|Baseline|Total|Total of all reporting groups
625090|NCT02791269|B2|Baseline|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625091|NCT02791269|B1|Baseline|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625092|NCT02791269|P2|Participant Flow|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625093|NCT02791269|P1|Participant Flow|HBeAg Negative Participants|Hepatitis B e antigen (HBeAg) negative participants received peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625094|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625095|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625096|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625097|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625098|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625099|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625100|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625101|NCT02791269|O2|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625102|NCT02791269|O1|Outcome|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period
625103|NCT02791269|O1|Outcome|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625104|NCT02791269|E2|Reported Event|HBeAg Positive Participants|HBeAg positive participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625105|NCT02791269|E1|Reported Event|HBeAg Negative Participants|HBeAg negative participants received peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
625106|NCT02790281|B1|Baseline|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
625107|NCT02790281|P1|Participant Flow|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
625108|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
625109|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
625110|NCT02790281|O1|Outcome|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
625111|NCT02790281|E1|Reported Event|Overall Study|Subjects included were diagnosed with active moderate to severe ulcerative colitis or Crohn’s disease and C-reactive protein (CRP) >5 mg/L.
625112|NCT02788097|B3|Baseline|Total|Total of all reporting groups
626712|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
625114|NCT02788097|B1|Baseline|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers"
625115|NCT02788097|P2|Participant Flow|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
625116|NCT02788097|P1|Participant Flow|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
625117|NCT02788097|O2|Outcome|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
625118|NCT02788097|O1|Outcome|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
625119|NCT02788097|E2|Reported Event|Progesterone + 5|"the transfer of day 5 blastocysts on the 6th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~69 patients randomized to this group"
625120|NCT02788097|E1|Reported Event|Progesterone + 4|"the transfer of day 5 blastocyst on the 5th day of progesterone supplementation~Progesterone supplementation: artificial frozen embryo transfers~61 patients randomized to this group"
625121|NCT02780622|B1|Baseline|All Participants|Participants were randomized to 1 of 2 treatment sequences: warfarin then oseltamivir 75 mg and warfarin; or oseltamivir 75 mg and warfarin then warfarin.
625122|NCT02780622|P2|Participant Flow|First Warfarin and Oseltamivir Then Warfarin|Participants received oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received warfarin (on Days 1-5) in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
625123|NCT02780622|P1|Participant Flow|First Warfarin Then Warfarin and Oseltamivir|Participants received warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants then received oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attended a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants continued to receive warfarin once daily at a prescribed usual dose throughout the study.
625124|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625125|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625126|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625127|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625128|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625129|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625130|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625131|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625132|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625133|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625134|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625135|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625136|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625137|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625138|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625139|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625140|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625141|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625142|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625143|NCT02780622|O1|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625144|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625145|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625146|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625147|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625148|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625149|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625150|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625151|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625152|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625153|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625154|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625155|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625156|NCT02780622|O2|Outcome|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625157|NCT02780622|O1|Outcome|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625158|NCT02780622|E2|Reported Event|Warfarin and Oseltamivir|Participants who received warfarin at a prescribed usual dose along with oseltamivir 75 mg, orally twice daily on Days 1-4 and once on Day 5 in treatment period 1 or treatment period 2.
625159|NCT02780622|E1|Reported Event|Warfarin|Participants who received Warfarin alone at a prescribed usual dose in treatment period 1 or treatment period 2.
625160|NCT02774278|B1|Baseline|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625161|NCT02774278|P1|Participant Flow|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625162|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625163|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625164|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625165|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625166|NCT02774278|O1|Outcome|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625167|NCT02774278|E1|Reported Event|Erlotinib|Erlotinib was administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
625168|NCT02773758|B3|Baseline|Total|Total of all reporting groups
625169|NCT02773758|B2|Baseline|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
625170|NCT02773758|B1|Baseline|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
625171|NCT02773758|P2|Participant Flow|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush containing 0.76% sodium monofluorophosphate (1000ppm fluoride), and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
625172|NCT02773758|P1|Participant Flow|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride), then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
625173|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
625174|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
625175|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
626713|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
625176|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
625177|NCT02773758|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Participants were instructed to apply a full brush head of toothpaste to a dry toothbrush, and then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
625178|NCT02773758|O1|Outcome|Stannous Fluoride Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
625179|NCT02773758|E2|Reported Event|Sodium Monofluorophosphate Dentifrice|Participants were instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water.
625180|NCT02773758|E1|Reported Event|Stannous Fluoride Dentifrice|Participants were instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants were permitted to rinse with tap water.
625181|NCT02772666|B1|Baseline|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
625182|NCT02772666|P1|Participant Flow|All Study Participants|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were enrolled.
625183|NCT02772666|O2|Outcome|Swinging Flashlight Test|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with manual swinging flashlight test(SFT).
625184|NCT02772666|O1|Outcome|O-Glass|44 patients diagnosed with relative afferent pupillary defect (RAPD- positive) were examined with O-Glass.
625185|NCT02772666|E1|Reported Event|All Study Participants|This diagnostic intervention is just an inspection and taking picture of the eye.
625186|NCT02767843|B1|Baseline|Treatment|"continuous negative external pressure (cNEP) at various negative pressures~continuous negative external pressure (cNEP): soft silicone collar placed on the anterior neck, to which a negative pressure is introduced"
625187|NCT02767843|P1|Participant Flow|Subjects|Only four subjects completed the study.
625188|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study. No efficacy data could be analyzed because of technical problems with the data collection equipment.
625189|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study.
625190|NCT02767843|O1|Outcome|Subjects|Only four subjects were entered into the study. None had outcome measure (2) collected because of technical problems with data collection. Thus no interpretable data were collected.
625191|NCT02767843|E1|Reported Event|All Subjects|Only four subjects completed the study.
625192|NCT02767765|B1|Baseline|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625193|NCT02767765|P1|Participant Flow|Recombinant Human Erythropoietin Beta (r-HuEPO)|Anemic cancer participants received r-HuEPO (NeoRecormon) as subcutaneous (SC) or intramuscular (IM) injection for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625194|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625195|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625196|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625197|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625198|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625199|NCT02767765|O1|Outcome|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625214|NCT02766244|O4|Outcome|Patient 2 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625739|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625200|NCT02767765|E1|Reported Event|r-HuEPO|Anemic cancer participants received r-HuEPO as SC or IM injection for 4 weeks, at a dose of 10000 IU/day according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
625201|NCT02766400|B3|Baseline|Total|Total of all reporting groups
625202|NCT02766400|B2|Baseline|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
625203|NCT02766400|B1|Baseline|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
625204|NCT02766400|P2|Participant Flow|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
625205|NCT02766400|P1|Participant Flow|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
625206|NCT02766400|O2|Outcome|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
625207|NCT02766400|O1|Outcome|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
625208|NCT02766400|E2|Reported Event|Directed Training|"Directed training is a rehabilitation approach that maximizes the expertise of the rehabilitation practitioner. Rehabilitation practitioners identify and prioritize problematic activities, identify barriers to performing these activities, generate strategies to address these barriers and instruct patients in these strategies, and repeat the process with a variety of problematic activities identified during the rehabilitation program. Directed training promotes independence with training activities, however the benefits of direct training are likely to be activity-specific (i.e., only promote improvement on the trained activity) and not generalizable to other daily activities. This therapist-directed approach is currently the method used most frequently in acute rehabilitation.~Directed Training"
625209|NCT02766400|E1|Reported Event|Guided Training|"Guided training is a rehabilitation training approach that maximizes the expertise of the patient, by teaching patients to identify and prioritize activities, identify barriers to performing activities, generate their own strategies for addressing these barriers, and apply this process through iterative practice. Guided training equips patients with practical skills that have the potential to generalize beyond activities addressed during the intervention program to novel problematic activities that arise after the intervention program, thereby promoting long-term independence.~Guided Training"
625210|NCT02766244|B1|Baseline|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625211|NCT02766244|P1|Participant Flow|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625212|NCT02766244|O6|Outcome|Patient 3 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625213|NCT02766244|O5|Outcome|Patient 3 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625740|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625215|NCT02766244|O3|Outcome|Patient 2 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625216|NCT02766244|O2|Outcome|Patient 1 Deep Tissue|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625217|NCT02766244|O1|Outcome|Patient 1 Superficial|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625218|NCT02766244|E1|Reported Event|ICG/SPY|"Daily wound care with antibiotic ointments after cleansing plus evaluation using ICG/SPY fluorescence.~ICG/SPY: indocyanine green fluorescence imaging~Antibiotic Ointment: Antibiotic ointment"
625219|NCT02765269|B3|Baseline|Total|Total of all reporting groups
625220|NCT02765269|B2|Baseline|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
625221|NCT02765269|B1|Baseline|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
625222|NCT02765269|P2|Participant Flow|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
625223|NCT02765269|P1|Participant Flow|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
625224|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
625225|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
625226|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
625227|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
625228|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
625229|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
625230|NCT02765269|O2|Outcome|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
625231|NCT02765269|O1|Outcome|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
625232|NCT02765269|E2|Reported Event|Control Group|The control group are communicated through conventional method such as telephone calls or door-to-door visit to collect the pain assessment to guide doctors' therapy.
625233|NCT02765269|E1|Reported Event|IPMS Group|"Cancer patients with pain are asked to use the Intelligent Pain Management System as much as possible to record the degree and location of pain at least once every day. Through assessments of these pain record, physicians could give the patients appropriate advice.~Intelligent Pain Management System: A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly."
625234|NCT02763189|B3|Baseline|Total|Total of all reporting groups
625235|NCT02763189|B2|Baseline|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
625236|NCT02763189|B1|Baseline|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
625237|NCT02763189|P2|Participant Flow|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
625238|NCT02763189|P1|Participant Flow|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
625741|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625239|NCT02763189|O2|Outcome|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
625240|NCT02763189|O1|Outcome|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
625241|NCT02763189|O2|Outcome|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
625242|NCT02763189|O1|Outcome|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
625243|NCT02763189|E2|Reported Event|Mentored|"Mentored group will study the learning materials and then receive expert mentoring~Expert mentoring: Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.~Self-study: All subjects will receive self-study"
625244|NCT02763189|E1|Reported Event|Control|"Control group will study the learning material independently. 'Self-study'.~Self-study: All subjects will receive self-study"
625245|NCT02761733|B5|Baseline|Total|Total of all reporting groups
625246|NCT02761733|B4|Baseline|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625247|NCT02761733|B3|Baseline|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625248|NCT02761733|B2|Baseline|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625249|NCT02761733|B1|Baseline|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625250|NCT02761733|P4|Participant Flow|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625251|NCT02761733|P3|Participant Flow|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625252|NCT02761733|P2|Participant Flow|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625253|NCT02761733|P1|Participant Flow|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625254|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625255|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625256|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625257|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625258|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625259|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625260|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625261|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625262|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625263|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625264|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625265|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625266|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625267|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625268|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625269|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625270|NCT02761733|O4|Outcome|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625271|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625272|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625273|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625742|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625275|NCT02761733|O3|Outcome|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625276|NCT02761733|O2|Outcome|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625277|NCT02761733|O1|Outcome|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625278|NCT02761733|E4|Reported Event|Control Site - Rural Setting|Treatment as usual. This site is based in rural New Mexico. (Mental Health Resources in Clovis, NM)
625279|NCT02761733|E3|Reported Event|Intervention Site - Rural Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in rural New Mexico. (Tri-County Community Services in Taos, NM)
625280|NCT02761733|E2|Reported Event|Control Site - Urban Setting|Treatment as usual. This site is based in inner city San Francisco, CA. (Gough Street Clinic)
625281|NCT02761733|E1|Reported Event|Intervention Site - Urban Setting|The clinical case mangers at this site were trained to implement the intervention. This site is based in inner city San Francisco, CA. (Geriatric Services West)
625282|NCT02761629|B3|Baseline|Total|Total of all reporting groups
625283|NCT02761629|B2|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625284|NCT02761629|B1|Baseline|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625285|NCT02761629|P2|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625286|NCT02761629|P1|Participant Flow|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received peg-interferon alpha-2A (Peg-IFN-Alpha-2A) and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 micrograms (mcg) once weekly via subcutaneous injection. Ribavirin was administered as either 1000 milligrams (mg) per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg.
625287|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625288|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625289|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625290|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625291|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625292|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625293|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625294|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625295|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625296|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625297|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625298|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625299|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625300|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625301|NCT02761629|O2|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625302|NCT02761629|O1|Outcome|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625303|NCT02761629|E2|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 72 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 72 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kg or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625304|NCT02761629|E1|Reported Event|Peg-IFN-Alpha-2A+Ribavirin - 48 Weeks|Participants received Peg-IFN-Alpha-2A and ribavirin for 48 weeks. Peg-IFN-Alpha-2A was administered at 180 mcg once weekly via subcutaneous injection. Ribavirin was administered as either 1000 mg per day (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing <75 kilograms (kg) or as 1200 mg per day (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing >/=75 kg.
625305|NCT02760654|B3|Baseline|Total|Total of all reporting groups
625306|NCT02760654|B2|Baseline|Control|Treatment as usual
625307|NCT02760654|B1|Baseline|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625308|NCT02760654|P2|Participant Flow|Control|Treatment as usual
625309|NCT02760654|P1|Participant Flow|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625310|NCT02760654|O2|Outcome|Control|Treatment as usual
625311|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625312|NCT02760654|O2|Outcome|Control|Treatment as usual
625313|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625314|NCT02760654|O2|Outcome|Control|Treatment as usual
625315|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625316|NCT02760654|O2|Outcome|Control|Treatment as usual
625317|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625318|NCT02760654|O2|Outcome|Control|Treatment as usual
625319|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625320|NCT02760654|O2|Outcome|Control|Treatment as usual
625321|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625322|NCT02760654|O2|Outcome|Control|Treatment as usual
625323|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625324|NCT02760654|O2|Outcome|Control|Treatment as usual
625325|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625326|NCT02760654|O2|Outcome|Control|Treatment as usual
625327|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625328|NCT02760654|O2|Outcome|Control|Treatment as usual
625329|NCT02760654|O1|Outcome|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625330|NCT02760654|E2|Reported Event|Control|Treatment as usual
625331|NCT02760654|E1|Reported Event|Online Self Management|"Participants will interact with an online self management program based on cognitive behavioral principles for 8 weeks as much as they want.~Proactive Self Management Program for Effects of Cancer Treatment"
625332|NCT02759471|B1|Baseline|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
625333|NCT02759471|P1|Participant Flow|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
625334|NCT02759471|O1|Outcome|Investigator Rating of Fit Preference|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
625335|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
625336|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
625337|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
625338|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
625339|NCT02759471|O2|Outcome|Comfilcon A Asphere (Test)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
625340|NCT02759471|O1|Outcome|Comfilcon A Sphere (Control)|habitual wearers of comfilcon A sphere are refitted with comfilcon A asphere
625341|NCT02759471|E1|Reported Event|Comfilcon A Sphere (Control) and Comfilcon A Asphere (Test)|"Habitual wearers of comfilcon A sphere lens (control) are refitted with comfilcon A asphere lens (test).~comfilcon A sphere lens (control): contact lens~comfilcon A asphere lens (test): contact lens"
625342|NCT02756637|B3|Baseline|Total|Total of all reporting groups
625343|NCT02756637|B2|Baseline|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
625344|NCT02756637|B1|Baseline|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
625345|NCT02756637|P2|Participant Flow|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
625346|NCT02756637|P1|Participant Flow|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
625347|NCT02756637|O2|Outcome|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
625348|NCT02756637|O1|Outcome|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
625349|NCT02756637|E2|Reported Event|Predictive Cohort|Patients with NLR who were assigned to a trial arm (chemo or no chemo)
625350|NCT02756637|E1|Reported Event|Prognostic Cohort|Patients with NLR who completed curative therapy (surgery with or without chemo)
625351|NCT02756351|B3|Baseline|Total|Total of all reporting groups
625352|NCT02756351|B2|Baseline|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
625353|NCT02756351|B1|Baseline|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
625354|NCT02756351|P2|Participant Flow|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
625355|NCT02756351|P1|Participant Flow|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
625356|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
625357|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
625358|NCT02756351|O2|Outcome|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
625359|NCT02756351|O1|Outcome|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
625360|NCT02756351|E2|Reported Event|Reference Nasal Prong|"Inspiration Healthcare Inspire nCPAP Nasal Prong consists of silicone. Is a Conformité Européenne marked (CE-marked) commercially available medical device.~Inspiration Healthcare Inspire nCPAP Nasal Prong"
626714|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
625361|NCT02756351|E1|Reported Event|CytaCoat Nasal Prong|"The CytaCoat Nasal Prong is composed of the reference device coated with CytaCoat technology.~CytaCoat Nasal Prong"
625362|NCT02755805|B3|Baseline|Total|Total of all reporting groups
625363|NCT02755805|B2|Baseline|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
625364|NCT02755805|B1|Baseline|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
625365|NCT02755805|P2|Participant Flow|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
625366|NCT02755805|P1|Participant Flow|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
625367|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
625368|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
625369|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
625370|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
625371|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
625372|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
625373|NCT02755805|O2|Outcome|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
625374|NCT02755805|O1|Outcome|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
625375|NCT02755805|E2|Reported Event|Attention Control|"The attention control intervention controls for the non-specific effects of strategy training. The therapists administer the standardized and dose-matched protocol, using scripted open-ended questions to facilitate participants' reflections on their rehabilitation activities and experiences. Participants complete a daily journal, merely reviewing their rehabilitation activities.~Attention Control"
625376|NCT02755805|E1|Reported Event|CO-OP|"Cognitive Orientation to daily Occupational Performance (CO-OP) is a strategy training approach that trains individuals to identify problems in the performance of their daily activities, develop strategies to address these problems, and monitor their own performance in the course of their daily routines. Participants use a workbook to support their application of the strategy training.~CO-OP"
625377|NCT02753699|B4|Baseline|Total|Total of all reporting groups
625378|NCT02753699|B3|Baseline|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
625379|NCT02753699|B2|Baseline|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
625380|NCT02753699|B1|Baseline|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
625381|NCT02753699|P3|Participant Flow|From Study 2211|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
625382|NCT02753699|P2|Participant Flow|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
626715|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
625385|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
625386|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
625387|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
625388|NCT02753699|O4|Outcome|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
625389|NCT02753699|O3|Outcome|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
625390|NCT02753699|O2|Outcome|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
625391|NCT02753699|O1|Outcome|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
625392|NCT02753699|E4|Reported Event|From Study 2211 Overall|All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study.
625393|NCT02753699|E3|Reported Event|From Study 2211 IFN-free|Participants enrolled from CDEB025A2211 (n=54) who had been treated with alisporivir in interferon-free (INF-free) regimens during the feeder study.
625394|NCT02753699|E2|Reported Event|From Study 2301|All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study.
625395|NCT02753699|E1|Reported Event|From Study 2210|All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study.
625396|NCT02753075|B4|Baseline|Total|Total of all reporting groups
625397|NCT02753075|B3|Baseline|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625398|NCT02753075|B2|Baseline|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625399|NCT02753075|B1|Baseline|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625400|NCT02753075|P3|Participant Flow|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625401|NCT02753075|P2|Participant Flow|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625402|NCT02753075|P1|Participant Flow|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F]) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625403|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625404|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625405|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625406|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625407|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625408|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625427|NCT02752802|B2|Baseline|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625409|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625410|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625411|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625412|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625413|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625414|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625415|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625416|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625417|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm fluoride F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625418|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625419|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625420|NCT02753075|O3|Outcome|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625421|NCT02753075|O2|Outcome|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625422|NCT02753075|O1|Outcome|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, 0 ppm F) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625423|NCT02753075|E3|Reported Event|Placebo Oral Rinse|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625424|NCT02753075|E2|Reported Event|Experimental Oral Rinse 2|Participants were instructed to brush their teeth with fluoride toothpaste for 1 min and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 mL of Experimental Oral Rinse 2 (2% w/w KOX, 45ppm F, pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625425|NCT02753075|E1|Reported Event|Experimental Oral Rinse 1|Participants were instructed to brush their teeth with fluoride toothpaste for 1 minute (min) and expectorate. They then rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated followed by rinsing with 10 milliliter (mL) of Experimental Oral Rinse 1 (1.5% weight by weight [w/w] dipotassium oxalate monohydrate [KOX], 0 parts per million [ppm] fluoride [F], pH 4.5) for 1 min and expectorated. This regimen was performed twice daily for 8 weeks.
625426|NCT02752802|B3|Baseline|Total|Total of all reporting groups
625492|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
625493|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
625428|NCT02752802|B1|Baseline|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625429|NCT02752802|P2|Participant Flow|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625430|NCT02752802|P1|Participant Flow|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625431|NCT02752802|O1|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625432|NCT02752802|O2|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625433|NCT02752802|O1|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625434|NCT02752802|O2|Outcome|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625435|NCT02752802|O1|Outcome|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625436|NCT02752802|E2|Reported Event|Control|"The control group will include standard of care for diagnostic coronary angiograms.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625437|NCT02752802|E1|Reported Event|Treatment|"The treatment group will include standard of care for diagnostic angiogram along with the utilizization of the DyeVert system.~Diagnostic Coronary Angiogram: Diagnostic angiographic procedure with the use of the DyeVert System."
625438|NCT02751450|B3|Baseline|Total|Total of all reporting groups
625439|NCT02751450|B2|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625440|NCT02751450|B1|Baseline|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625441|NCT02751450|P2|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625442|NCT02751450|P1|Participant Flow|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million, ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625443|NCT02751450|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625444|NCT02751450|O1|Outcome|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625445|NCT02751450|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625446|NCT02751450|O1|Outcome|Stannous Fluoride Dentifice|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625494|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
625447|NCT02751450|O2|Outcome|Sodium Monofluorophosphate Dentifrice|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625448|NCT02751450|O1|Outcome|Stannous Fluoride Dentifice|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625449|NCT02751450|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625450|NCT02751450|O1|Outcome|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625451|NCT02751450|E2|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625452|NCT02751450|E1|Reported Event|Stannous Fluoride|Experimental: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. Participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
625453|NCT02750943|B3|Baseline|Total|Total of all reporting groups
625454|NCT02750943|B2|Baseline|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625455|NCT02750943|B1|Baseline|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625456|NCT02750943|P2|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625457|NCT02750943|P1|Participant Flow|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% weight by weight (w/w) stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625458|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625459|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625460|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625461|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625462|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625463|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625464|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625465|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625495|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
625466|NCT02750943|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625467|NCT02750943|O1|Outcome|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625468|NCT02750943|E2|Reported Event|Sodium Monofluorophosphate|Participants were instructed to apply a full ribbon of dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625469|NCT02750943|E1|Reported Event|Stannous Fluoride|Participants were instructed to apply a full ribbon of dentifrice containing 0.454% w/w stannous fluoride to the study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) for 12 weeks.
625470|NCT02750709|B1|Baseline|All Study Participants|
625471|NCT02750709|P6|Participant Flow|Treatment Sequence C (Reference) - B (TP 2) - A (TP 1)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
625472|NCT02750709|P5|Participant Flow|Treatment Sequence C (Reference) - A (TP 1) - B (TP 2)|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
625473|NCT02750709|P4|Participant Flow|Treatment Sequence B (TP 2) - C (Reference) - A (TP 1)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
625474|NCT02750709|P3|Participant Flow|Treatment Sequence B (TP 2) - A (TP 1) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
625475|NCT02750709|P2|Participant Flow|Treatment Sequence A (TP 1) - C (Reference) - B (TP 2)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
625476|NCT02750709|P1|Participant Flow|Treatment Sequence A (TP 1) - B (TP 2) - C (Reference)|"Subjects will receive a single 10 mg tablet of Nitisinone 10 mg Tablet (Test Product 1) in treatment period 1, 10 mg tablet of Nitisinone 10 mg Tablet High Compritol (Test Product 2) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.~Nitisinone 10 mg Tablet High Compritol: A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state."
625477|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
625478|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
625479|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
625480|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
625481|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
625482|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
625483|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
625484|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
625485|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
625486|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
625487|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
625488|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
625489|NCT02750709|O3|Outcome|Reference Product|ORFADIN® hard capsule, 10 mg
625490|NCT02750709|O2|Outcome|Treatment Period 2|Nitisinone Tablet (High Compritol), 10 mg
625491|NCT02750709|O1|Outcome|Treatment Period 1|Nitisinone Tablet, 10 mg
625502|NCT02750345|P6|Participant Flow|Sequence Reference - TP 2 - TP 1|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
625503|NCT02750345|P5|Participant Flow|Sequence Reference - TP 1 - TP 2|"Subjects will receive a single 10 mg hard capsule of Orfadin (Reference) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
625504|NCT02750345|P4|Participant Flow|Sequence TP 2 - Reference - TP 1|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone (Test Product 1) in treatment period 3, and under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
625505|NCT02750345|P3|Participant Flow|Sequence TP 2 - TP 1 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 1, 10 mg tablet of Nitisinone (Test Product 1) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
625506|NCT02750345|P2|Participant Flow|Sequence TP 1 - Reference - TP 2|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1) in treatment period 1, 10 mg hard capsule of Orfadin (Reference) in treatment period 2, and 10 mg tablet of Nitisinone Baked Tablet (Test Product 2) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
625507|NCT02750345|P1|Participant Flow|Sequence TP 1 - TP 2 - Reference|"Subjects will receive a single 10 mg tablet of Nitisinone (Test Product 1 (TP 1)) in treatment period 1, 10 mg tablet of Nitisinone Baked Tablet (Test Product 2 (TP 2)) in treatment period 2, and 10 mg hard capsule of Orfadin (Reference) in treatment period 3 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered.~Nitisinone Baked Tablet: A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.~Orfadin: A single oral dose of Orfadin 10 mg hard capsule will be administered."
625508|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
625509|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625510|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
625511|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
625512|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625513|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
625514|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
625515|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625516|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
625517|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
625518|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625519|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
625520|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
625521|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625522|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
625523|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
625524|NCT02750345|O2|Outcome|Treatment Period 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625525|NCT02750345|O1|Outcome|Treatment Period 1|10 mg Nitisinone Tablet
625526|NCT02750345|O3|Outcome|Reference Product|ORFADIN®, 10 mg hard capsule
625527|NCT02750345|O2|Outcome|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625528|NCT02750345|O1|Outcome|Test Product 1|10 mg Nitisinone Tablet
625529|NCT02750345|E3|Reported Event|Reference Product|ORFADIN®, 10 mg hard capsule
625530|NCT02750345|E2|Reported Event|Test Product 2|Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH)
625531|NCT02750345|E1|Reported Event|Test Product 1|10 mg Nitisinone Tablet
625532|NCT02750332|B1|Baseline|All Study Participants|
625533|NCT02750332|P2|Participant Flow|Treatment Sequence B (Fasted) - A (Fed)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fasting conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fed conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
625641|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625642|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625534|NCT02750332|P1|Participant Flow|Treatment Sequence A (Fed) - B (Fasted)|"Subjects will receive a single 10 mg tablet of Nitisinone in treatment period 1 under fed conditions, and 10 mg tablet of Nitisinone in treatment period 2 under fasting conditions. Each treatment period will be separated by at least 23 calendar days of washout period.~Nitisinone: A single oral dose of Nitisinone 10 mg Tablet will be administered."
625535|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625536|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625537|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625538|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625539|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625540|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625541|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625542|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625543|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625544|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625545|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625546|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625547|NCT02750332|O2|Outcome|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625548|NCT02750332|O1|Outcome|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625549|NCT02750332|E2|Reported Event|Test Product (Fed)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fed conditions.
625550|NCT02750332|E1|Reported Event|Test Product (Fasted)|A single oral dose of Nitisinone 10 mg Tablet will be administered under fasted conditions.
625551|NCT02748213|B3|Baseline|Total|Total of all reporting groups
625552|NCT02748213|B2|Baseline|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625553|NCT02748213|B1|Baseline|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625554|NCT02748213|P2|Participant Flow|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625555|NCT02748213|P1|Participant Flow|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via intravenous (IV) infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 milligrams per kilogram (mg/kg) in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 milligrams per meter-squared (mg/m^2), with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625556|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625557|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625558|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625559|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625560|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625561|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625562|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625563|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625564|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625565|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625566|NCT02748213|O2|Outcome|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625567|NCT02748213|O1|Outcome|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625568|NCT02748213|E2|Reported Event|Herceptin + Taxotere|Participants received dual therapy with Herceptin and Taxotere until disease progression, unmanageable toxicity, or withdrawal. Treatments were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 100 mg/m^2, with adjustments allowed only for toxicity.
625569|NCT02748213|E1|Reported Event|Herceptin + Taxotere + Xeloda|Participants received triple therapy with Herceptin, Taxotere, and Xeloda until disease progression, unmanageable toxicity, or withdrawal. Herceptin and Taxotere were given via IV infusion on Day 1 of each 21-day cycle. The first dose of Herceptin was a loading dose of 8 mg/kg in Cycle 1, and a maintenance dose of 6 mg/kg was given from Cycle 2 through the end of treatment. The dose of Taxotere was 75 mg/m^2, with adjustments allowed only for toxicity. Xeloda was given orally as 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle, with adjustments allowed only for toxicity.
625570|NCT02746679|B3|Baseline|Total|Total of all reporting groups
625571|NCT02746679|B2|Baseline|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625572|NCT02746679|B1|Baseline|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625573|NCT02746679|P2|Participant Flow|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625643|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625644|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625645|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625574|NCT02746679|P1|Participant Flow|MBSR Group|"The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.~Mindfulness Based Stress Reduction: Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this"
625575|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625576|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625577|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625578|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625579|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625580|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625581|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625582|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625583|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625584|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625585|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625586|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625587|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625646|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625588|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625589|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625590|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625591|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625592|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625593|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625594|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625595|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625596|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625597|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625598|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625599|NCT02746679|O2|Outcome|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625600|NCT02746679|O1|Outcome|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625601|NCT02746679|E2|Reported Event|Wait-list Control Group|The patients assigned to the wait-list control group did not receive MBSR intervention for 8 weeks when participants in MBSR were engaged in the MBSR intervention.They only received conventional therapy.
625647|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625648|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
629827|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
625602|NCT02746679|E1|Reported Event|MBSR Group|The Mindfulness Based Stress Reduction program consisted of eight weekly sessions, each 2.5 hours long, and delivered on consecutive weeks.The Mindfulness Based Stress Reduction therapist participated in the mindfulness exercises with group members during the weekly sessions, and group members were instructed to practice these mindfulness exercises outside group meetings for at least 45 minutes per day, 6 days per week.Group members were taught three main varieties of mindfulness skills: the body scan exercise, sitting meditation, and yoga exercises.The daily homework exercises consisted of repeating body scan work, sitting meditation and yoga exercises at home to provide practice and generalization of the skills.
625603|NCT02746406|B1|Baseline|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
625604|NCT02746406|P1|Participant Flow|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
625605|NCT02746406|O1|Outcome|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
625606|NCT02746406|E1|Reported Event|Peritron+|"SMIP assessment using Peritron+, Air-Trap Tubing, and a conventional CIC catheter~Peritron+: Peritron+ device to measure intravesical pressure"
625607|NCT02746107|B1|Baseline|All Participants|all participants in the study (968)
625608|NCT02746107|P1|Participant Flow|All Study Participants|all study participants were 968 (in all arms of this factorial RCT)
625609|NCT02746107|O5|Outcome|CHA2D2S-VASC Risk Score 5|
625610|NCT02746107|O4|Outcome|CHA2D2S-VASC Risk Score 4|
625611|NCT02746107|O3|Outcome|CHA2D2S-VASC Risk Score 3|
625612|NCT02746107|O2|Outcome|CHA2D2S-VASC Risk Score 2|
625613|NCT02746107|O1|Outcome|CHA2D2S-VASC Risk Score 1|
625614|NCT02746107|O2|Outcome|Prescription to Physician Himself|the participants had to imagine that they had atrial fibrillation, the risk from the diagram was theirs, and had to decide to take or not the OACs
625615|NCT02746107|O1|Outcome|Prescription to Patient|the participant physician were randomized to prescribe OAC to virtual patients
625616|NCT02746107|O2|Outcome|1 Year Risk Estimation on DA (CHA2D2S-VASC Score)|participants deciding to prescribe or not OAC after seeing the stroke risk estimation on 1 year (classical CHA2D2S-VASC score)
625617|NCT02746107|O1|Outcome|5 Years Risk Estimation on DA|participants had to prescribe or not OAC after seeing the risk estimated on 5 years
625618|NCT02746107|O2|Outcome|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams"
625619|NCT02746107|O1|Outcome|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams"
625620|NCT02746107|E2|Reported Event|Two Diagrams|"classical decision aid with 2 diagrams (risk without treatment, and risk with treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 406 of 482 (83.5%)"
625621|NCT02746107|E1|Reported Event|One Diagram|"decision aid with one diagram (risk under treatment)~decision aid: decision aid with one/two diagrams~OAC prescribed: 400 of 486 (83%)"
625622|NCT02745626|B4|Baseline|Total|Total of all reporting groups
625623|NCT02745626|B3|Baseline|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625624|NCT02745626|B2|Baseline|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625625|NCT02745626|B1|Baseline|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625626|NCT02745626|P3|Participant Flow|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625627|NCT02745626|P2|Participant Flow|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625628|NCT02745626|P1|Participant Flow|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625629|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625630|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625631|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625632|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625633|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625634|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625635|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625636|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625637|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625638|NCT02745626|O3|Outcome|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625639|NCT02745626|O2|Outcome|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625640|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
626716|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
625649|NCT02745626|O1|Outcome|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625650|NCT02745626|E3|Reported Event|Conventional Bracket Appliance|"Preadjusted edge wise brackets using elastomeric ties.~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625651|NCT02745626|E2|Reported Event|Self-ligating Appliance|"Carriere Self-Ligating Bracket, Carlsbad, CA~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625652|NCT02745626|E1|Reported Event|Clear Aligner Appliance|"Clear Aligners, Align Technology Inc., Santa Clara, California~Appliance: Orthodontic appliance to carry out orthodontic tooth movement."
625653|NCT02743702|B3|Baseline|Total|Total of all reporting groups
625654|NCT02743702|B2|Baseline|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
625655|NCT02743702|B1|Baseline|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
625656|NCT02743702|P2|Participant Flow|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
625657|NCT02743702|P1|Participant Flow|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his"
625658|NCT02743702|O2|Outcome|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
625659|NCT02743702|O1|Outcome|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for one year. Sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
625660|NCT02743702|E2|Reported Event|GROUP RECEIVING THEIR USUAL THERAPIES|"This group received no approach of their respiratory difficulties by Physiotherapy. Only continued their usual therapies.~USUAL THERAPIES"
625661|NCT02743702|E1|Reported Event|GROUP RECEIVING RESPIRATORY PHYSIOTHERAPY|"Respiratory Physiotherapy sessions were held once a week by the physiotherapist, and four times more for the family at home, for 1 year. The sessions have a duration between 30-45 minutes, varying according to the level of patient cooperation. The exercise program should be repeated in three cycles, although younger children took longer than older in performing them.~RESPIRATORY PHYSIOTHERAPY: The protocol designed was composed of the following exercises:~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mou"
625662|NCT02743936|B3|Baseline|Total|Total of all reporting groups
625663|NCT02743936|B2|Baseline|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625664|NCT02743936|B1|Baseline|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625665|NCT02743936|P2|Participant Flow|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625666|NCT02743936|P1|Participant Flow|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
626717|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
625667|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625668|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625669|NCT02743936|O2|Outcome|NIPPV Without Nasal Cannula|"Non-invasive positive pressure ventilation without nasal cannula~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625670|NCT02743936|O1|Outcome|NIPPV With Nasal Cannula|"Non-invasive positive pressure ventilation with nasal cannula in place~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625671|NCT02743936|E2|Reported Event|NIPPV Without Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) without nasal cannula first then NIPPV with nasal cannula~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625672|NCT02743936|E1|Reported Event|NIPPV With Nasal Cannula First|"Non-invasive positive pressure ventilation (NIPPV) with nasal cannula in place followed by NIPPV without nasal cannula in place.~Nasal cannula: Placement of nasal cannula under non-invasive positive pressure ventilation mask~Non-invasive positive pressure ventilation: Non-invasive positive pressure ventilation"
625673|NCT02739594|B3|Baseline|Total|Total of all reporting groups
625674|NCT02739594|B2|Baseline|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625675|NCT02739594|B1|Baseline|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625676|NCT02739594|P2|Participant Flow|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625677|NCT02739594|P1|Participant Flow|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625678|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625679|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625680|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625681|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625682|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625683|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625684|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625685|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625686|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625734|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
629828|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
625687|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625688|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625689|NCT02739594|O1|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625690|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625691|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625692|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625693|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625694|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625695|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625696|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625697|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625698|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625699|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625700|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625701|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625702|NCT02739594|O2|Outcome|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625703|NCT02739594|O1|Outcome|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625704|NCT02739594|E2|Reported Event|Zoledronate|Participants with multiple myeloma received zoledronate via 15-minute IV infusion as 4 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625735|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625705|NCT02739594|E1|Reported Event|Ibandronate|Participants with multiple myeloma received ibandronate via 15-minute IV infusion as 6 mg every 4 weeks for up to 92 weeks. As a result of slow recruitment, the treatment duration was shortened to 40 weeks for participants who had not yet received 48 weeks of treatment. All participants returned for an additional follow-up observation 4 weeks after the end of treatment.
625706|NCT02737592|B1|Baseline|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
625707|NCT02737592|P1|Participant Flow|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
625708|NCT02737592|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
625709|NCT02737592|O1|Outcome|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
625710|NCT02737592|E1|Reported Event|Healthy Subject|"Healthy subject exposed to Trojan Simply Pleasures Personal Lubricant at least four times weekly for two weeks~Trojan Simply Pleasure Personal Lubricant: silicone base without sensate"
625711|NCT02736721|B1|Baseline|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625712|NCT02736721|P1|Participant Flow|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544 (NCT number not available), NO16006 (NCT number not available) or ML17228 (NCT number not available) and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 microgram (mcg) once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625713|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625714|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625715|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625716|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625717|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625718|NCT02736721|O1|Outcome|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625719|NCT02736721|E1|Reported Event|Peginterferon Alfa-2a|Participants who have previously participated in study ML16544, NO16006, or ML17228 and deemed to be a responder, received peginterferon alfa-2a subcutaneously in doses between 90 and 450 mcg once weekly until medically indicated as judged by the treating investigator. Maximum treatment duration was approximately up to 7 years.
625720|NCT02735200|B3|Baseline|Total|Total of all reporting groups
625721|NCT02735200|B2|Baseline|Application of Aloe Vera Gel|Intervention: aloe vera gel administration 1 gram
625722|NCT02735200|B1|Baseline|Topical Application of Vitamin D3|this arm received topical vitamin D3 1gram (5000IU)
625723|NCT02735200|P2|Participant Flow|Topical Application of Vitamin D3|topical vitamin D3 in intervention group: local application of Top-D, 1 gram (5000 IU) was applied every day, for 120 days.
625724|NCT02735200|P1|Participant Flow|Application of Aloe Vera Gel|Intervention: aloe vera gel administration was applied 1 gram daily for 120 days.
625725|NCT02735200|O2|Outcome|Application of Aloe Vera Gel|Intervention: aloe vera gel administration
625726|NCT02735200|O1|Outcome|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU~topical vitamin D3 in intervention group: local application"
625727|NCT02735200|E2|Reported Event|Application of Aloe Vera Gel|"Intervention: aloe vera gel administration~topical vitamin D3 in intervention group: local application"
625728|NCT02735200|E1|Reported Event|Topical Application of Vitamin D3|"Intervention: patients will be administered topical vitamin D3 5000 IU~topical vitamin D3 in intervention group: local application"
625729|NCT02734355|B3|Baseline|Total|Total of all reporting groups
625730|NCT02734355|B2|Baseline|Placebo|"Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days~Placebo (for telmisartan and amlodipine): Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet"
625731|NCT02734355|B1|Baseline|Therapy|"Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days~Telmisartan 80 mg and amlodipine 5 mg"
625732|NCT02734355|P2|Participant Flow|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625733|NCT02734355|P1|Participant Flow|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625743|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625744|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625745|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625746|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625747|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625748|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625749|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625750|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625751|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625752|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625753|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625754|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625755|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625756|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625757|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625758|NCT02734355|O2|Outcome|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625759|NCT02734355|O1|Outcome|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625760|NCT02734355|E2|Reported Event|Placebo|Placebo (for telmisartan 80 mg and amlodipine 5 mg) tablet by mouth every 24 hours for 7 days
625761|NCT02734355|E1|Reported Event|Therapy|Telmisartan 80 mg and amlodipine 5 mg tablet by mouth every 24 hours for 7 days
625762|NCT02734056|B3|Baseline|Total|Total of all reporting groups
625763|NCT02734056|B2|Baseline|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
625764|NCT02734056|B1|Baseline|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
625765|NCT02734056|P2|Participant Flow|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
625766|NCT02734056|P1|Participant Flow|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
625767|NCT02734056|O2|Outcome|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
625768|NCT02734056|O1|Outcome|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
625769|NCT02734056|E2|Reported Event|Control|"There is no intervention listed here because this is the control group, in which there will be no intervention.~Control: Control"
625770|NCT02734056|E1|Reported Event|Music|"The intervention to be administered is music~Music: Listening to music that the patient likes"
625771|NCT02732639|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625772|NCT02732639|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625773|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625774|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625775|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625776|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625777|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625778|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625779|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625780|NCT02732639|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625781|NCT02732639|E1|Reported Event|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 48 weeks, followed by 24 weeks of treatment-free follow-up.~Pegylated Interferon (PEG-IFN) alfa-2a: Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks."
625782|NCT02732561|B3|Baseline|Total|Total of all reporting groups
625783|NCT02732561|B2|Baseline|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
625784|NCT02732561|B1|Baseline|Sham Device|"Sham device~Sham device: Sham device"
625785|NCT02732561|P2|Participant Flow|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
625786|NCT02732561|P1|Participant Flow|Sham Device|"Sham device~Sham device: Sham device"
625787|NCT02732561|O2|Outcome|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
625788|NCT02732561|O1|Outcome|Sham Device|"Sham device~Sham device: Sham device"
625789|NCT02732561|O2|Outcome|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
625790|NCT02732561|O1|Outcome|Sham Device|"Sham device~Sham device: Sham device"
625791|NCT02732561|E2|Reported Event|Intervention|"CES device. cranial electrotherapy stimulation device. Alpha Stim device~Alpha Stim device: cranial electrotherapy stimulation device"
625792|NCT02732561|E1|Reported Event|Sham Device|"Sham device~Sham device: Sham device"
625793|NCT02732210|B3|Baseline|Total|Total of all reporting groups
625794|NCT02732210|B2|Baseline|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625795|NCT02732210|B1|Baseline|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625796|NCT02732210|P2|Participant Flow|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625797|NCT02732210|P1|Participant Flow|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625798|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625799|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625800|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625801|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625802|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625803|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625804|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625805|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625806|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625807|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625808|NCT02732210|O2|Outcome|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625809|NCT02732210|O1|Outcome|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625810|NCT02732210|E2|Reported Event|United States|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in the United States.
625811|NCT02732210|E1|Reported Event|Canada|Postmenopausal women with osteoporosis treated with Prolia® 60 mg administered subcutaneously every 6 months (Q6M) in routine clinical practice at study sites in Canada.
625812|NCT02731833|B3|Baseline|Total|Total of all reporting groups
625813|NCT02731833|B2|Baseline|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625814|NCT02731833|B1|Baseline|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625815|NCT02731833|P2|Participant Flow|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625816|NCT02731833|P1|Participant Flow|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625817|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625818|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625819|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625820|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625821|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625822|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625823|NCT02731833|O2|Outcome|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625824|NCT02731833|O1|Outcome|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625825|NCT02731833|E2|Reported Event|Sodium Monofluorophosphate|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride). Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625826|NCT02731833|E1|Reported Event|Stannous Fluoride|Participants were instructed to dose a dry toothbrush with a full strip (1 inch) of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
625827|NCT02731313|B1|Baseline|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma Samples|"Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned~Trastuzumab: Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions."
625828|NCT02731313|P1|Participant Flow|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
625829|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
625830|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
625831|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
625832|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
625833|NCT02731313|O1|Outcome|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
625834|NCT02731313|E1|Reported Event|Gastric and Gastro-Esophageal Junction (GEJ) Carcinoma|Tumor samples with histologically confirmed gastric or GEJ adenocarcinoma, any stage, were collected and analyzed. No study visits or interventions were planned
625835|NCT02731300|B3|Baseline|Total|Total of all reporting groups
625836|NCT02731300|B2|Baseline|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625837|NCT02731300|B1|Baseline|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
629829|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
625838|NCT02731300|P2|Participant Flow|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625839|NCT02731300|P1|Participant Flow|Active tDCS|"2 milliampere (mA) of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625840|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625841|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625842|NCT02731300|O2|Outcome|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625843|NCT02731300|O1|Outcome|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625844|NCT02731300|E2|Reported Event|Sham tDCS|"0 mA of sham tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625845|NCT02731300|E1|Reported Event|Active tDCS|"2 mA of cathodal tDCS placed over M1 for 20 mins~tDCS: brain stimulation by cathodal electrode at motor cortex"
625846|NCT02731131|B3|Baseline|Total|Total of all reporting groups
625847|NCT02731131|B2|Baseline|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625848|NCT02731131|B1|Baseline|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625849|NCT02731131|P2|Participant Flow|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 milligrams (mg) per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625850|NCT02731131|P1|Participant Flow|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
625851|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625852|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625853|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625854|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625855|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625856|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625857|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625858|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625859|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625860|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625861|NCT02731131|O2|Outcome|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625862|NCT02731131|O1|Outcome|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625863|NCT02731131|E2|Reported Event|Group B: Combination With Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a plus ribavirin for 48 weeks. Peginterferon alfa-2a was given as 180 mcg once weekly via SC injection. Ribavirin was administered as 1000 to 1200 mg per day in divided (morning/evening) oral doses. The specific dose was determined according to the participant's body weight at Baseline.
625864|NCT02731131|E1|Reported Event|Group A: Monotherapy With Peginterferon Alfa-2a|Participants received peginterferon alfa-2a for 48 weeks as 180 mcg once weekly via SC injection.
625865|NCT02730260|B3|Baseline|Total|Total of all reporting groups
625866|NCT02730260|B2|Baseline|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
625919|NCT02723188|B3|Baseline|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
625867|NCT02730260|B1|Baseline|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
625868|NCT02730260|P2|Participant Flow|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
625869|NCT02730260|P1|Participant Flow|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
625870|NCT02730260|O2|Outcome|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
625871|NCT02730260|O1|Outcome|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
625872|NCT02730260|E2|Reported Event|Nondirective|"Participants receive up to 7 nondirective smoking cessation coaching telephone calls from the quitline over 9 weeks.~Nondirective smoking cessation coaching: Quitline coach allows participant to set agenda for each call."
625873|NCT02730260|E1|Reported Event|Directive|"Participants receive up to 7 directive smoking cessation coaching telephone calls from the quitline over 9 weeks.~Directive smoking cessation coaching: Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda."
625874|NCT02726971|B3|Baseline|Total|Total of all reporting groups
625875|NCT02726971|B2|Baseline|6mg Estradiol Therapy(High Dose)|"mean Age(y):32.3 Gender:Female BMI:21.0 mean Number of miscarriage: 2.1~BMI=body mass index"
625876|NCT02726971|B1|Baseline|2mg Estradiol Therapy(Low Dose)|"mean Age(y):31.9 Gender:Female BMI:21.2 mean Number of miscarriage: 2.3~BMI=body mass index"
625877|NCT02726971|P2|Participant Flow|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625878|NCT02726971|P1|Participant Flow|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625879|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625880|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625881|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625882|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625883|NCT02726971|O2|Outcome|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625884|NCT02726971|O1|Outcome|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625885|NCT02726971|E2|Reported Event|6mg Estradiol Therapy(High Dose)|"6mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625886|NCT02726971|E1|Reported Event|2mg Estradiol Therapy(Low Dose)|"2mg oral E2 (Femoston, Abbott Biologicals B.V.) daily for 21 days, followed by 20mg dydrogesterone daily for the last 10 days of hormone treatment.~Femoston: Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone."
625887|NCT02726178|B3|Baseline|Total|Total of all reporting groups
625888|NCT02726178|B2|Baseline|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625889|NCT02726178|B1|Baseline|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625890|NCT02726178|P2|Participant Flow|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625914|NCT02724449|B1|Baseline|Cavilon Advanced Barrier Film|"Cavilon Advanced Barrier Film applied to areas of IAD~Cavilon Advanced Barrier Film: Cavilon Advanced Barrier Fim's application applied twice a week"
625915|NCT02724449|P1|Participant Flow|Open-label Study|No competitive products evaluated.
625891|NCT02726178|P1|Participant Flow|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625892|NCT02726178|O2|Outcome|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625893|NCT02726178|O1|Outcome|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625894|NCT02726178|E2|Reported Event|Control|"Oral placebo: composed of sodium stearate 0.25g + lactose 0.5g + 15 ml of simple syrup, with a measured osmolarity of about 750 mosml/kg.~The drug (or placebo) was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Placebo: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625895|NCT02726178|E1|Reported Event|Advil® Pediatric Drops for Infants|"Oral ibuprofen (Advil® Pediatric drops for infants less than 3 months of age; Wyeth-Ayerst 40 mg/ml, DIN 2242522), at a dosage of 5 mg/kg/dose.~The drug was administered 30 minutes prior to immunization, and then at 8 and 16 hours following the immunization for a total of 3 doses.~Advil® Pediatric drops for infants: Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants"
625896|NCT02726022|B1|Baseline|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625897|NCT02726022|P1|Participant Flow|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a (Pegasys) and ribavirin (Copegus) for four weeks, were observed up to 24 weeks after end of treatment (EOT) (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625898|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625899|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625900|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625901|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625902|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625903|NCT02726022|O1|Outcome|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625904|NCT02726022|E1|Reported Event|Chronic Hepatitis C Participants|Participants with chronic hepatitis C, who were under treatment with peg-interferon alfa-2a and ribavirin for four weeks, were observed up to 24 weeks after EOT (up to 72 weeks). Peg-interferon alfa-2a and ribavirin were administered as per treating physician discretion and according to summary of product characteristics.
625905|NCT02725788|B3|Baseline|Total|Total of all reporting groups
625906|NCT02725788|B2|Baseline|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
625907|NCT02725788|B1|Baseline|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
625908|NCT02725788|P2|Participant Flow|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
625909|NCT02725788|P1|Participant Flow|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
625910|NCT02725788|O2|Outcome|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
625911|NCT02725788|O1|Outcome|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
625912|NCT02725788|E2|Reported Event|Standard PIV Dressing|Film adhesive dressing used with medical grade tape and sized to cover, secure peripheral (PIV) catheters
625913|NCT02725788|E1|Reported Event|New Dressing|Bordered, notched film dressing sized to cover, secure peripheral venous (PIV) catheters
625916|NCT02724449|O1|Outcome|Open Label Study|
625920|NCT02723188|B2|Baseline|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
625921|NCT02723188|B1|Baseline|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
625922|NCT02723188|P3|Participant Flow|AC (Alternating Current)|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
625923|NCT02723188|P2|Participant Flow|DC (Direct Current)|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
625924|NCT02723188|P1|Participant Flow|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
625925|NCT02723188|O3|Outcome|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
625926|NCT02723188|O2|Outcome|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
625927|NCT02723188|O1|Outcome|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
625928|NCT02723188|O3|Outcome|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
625929|NCT02723188|O2|Outcome|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
625930|NCT02723188|O1|Outcome|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
625931|NCT02723188|E3|Reported Event|AC: Alternating Current|"Alternating current electrical stimulation~AC stimulation (1.5 milliampere,1.5 Hertz frequency)"
625932|NCT02723188|E2|Reported Event|DC: Direct Current|"Direct current electrical stimulation~DC stimulation (1.5 milliampere, 20 minutes)"
625933|NCT02723188|E1|Reported Event|Sham|"Sham electrical stimulation~Sham stimulation (1.5 milliampere,30 seconds)"
625934|NCT02722564|B1|Baseline|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
625935|NCT02722564|P1|Participant Flow|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
625936|NCT02722564|O1|Outcome|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
625937|NCT02722564|E1|Reported Event|All Study Participants|"subject will self estimate breath alcohol content after each beer ingested~self estimation of breath alcohol content~record breath alcohol content as measured by breathalyzer~drink a beer: drink a beer, repeat until breath alcohol content 0.1"
625938|NCT02721641|B1|Baseline|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
625939|NCT02721641|P1|Participant Flow|Herceptin|Participants received intravenous (IV) Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
625940|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
625941|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
625942|NCT02721641|O1|Outcome|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
625943|NCT02721641|E1|Reported Event|Herceptin|Participants received IV Herceptin until disease progression, unacceptable toxicity, death, or decision by the investigator or participant to discontinue treatment. Herceptin was administered at the discretion of the investigator as either 2 mg/kg once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
625944|NCT02721277|B1|Baseline|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625974|NCT02720952|P1|Participant Flow|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
626718|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
625945|NCT02721277|P1|Participant Flow|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625946|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625947|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625948|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625949|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625950|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625951|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625975|NCT02720952|O4|Outcome|Question 4|Percentage of parents/carers that agreed, or strongly agreed with the statement: Overall, I would prefer Infacort for my child over the usual hydrocortisone medication.
625976|NCT02720952|O3|Outcome|Question 3|Percentage of parents/carers that agreed, or strongly agreed with the statement: I would be happy to give my child Infacort in the future.
625977|NCT02720952|O2|Outcome|Question 2|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child showed a positive reaction after Infacort was given.
625978|NCT02720952|O1|Outcome|Question 1|Percentage of parents/carers that agreed, or strongly agreed with the statement: My child found swallowing easy.
625952|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625953|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625954|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625955|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625956|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625957|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625958|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625979|NCT02720952|O1|Outcome|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
626153|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626154|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
629830|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
625959|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625960|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625961|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625962|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625963|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625964|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625965|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625980|NCT02720952|O1|Outcome|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
626155|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626156|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
629831|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
625966|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625967|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625968|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625969|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625970|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625971|NCT02721277|O1|Outcome|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625972|NCT02721277|E1|Reported Event|SMOFlipid|"Subjects with cholestasis will receive 3 G/kg/day of intravenous SMOFlipid daily until parenteral nutrition (PN) is discontinued. In addition, the following monitoring for effects of SMOFlipid will be performed: total days of parenteral nutrition, maximum conjugated bilirubin, time to resolution of bilirubin, time to liver transplant, time to death, positive blood cultures, rates of increase in weight, length, and head circumference, time dependent changes in liver function tests, including triglycerides, and length of hospital stay.~SMOFlipid: SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids."
625973|NCT02720952|B1|Baseline|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
626157|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626158|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
629832|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
625981|NCT02720952|E1|Reported Event|Infacort|"Infacort® is a dry granule formulation of hydrocortisone stored in capsules that will be available in different strengths (0.5, 1.0, 2.0 and 5.0mg).~The clinically-appropriate dose, based on standard individualised treatment, will be administered, given as a single dose orally. This will usually be equivalent to the previous day’s dose.~Infacort®: dry granule formulation of hydrocortisone"
625982|NCT02717754|B7|Baseline|Total|Total of all reporting groups
625983|NCT02717754|B6|Baseline|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
625984|NCT02717754|B5|Baseline|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
625985|NCT02717754|B4|Baseline|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
625986|NCT02717754|B3|Baseline|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
625987|NCT02717754|B2|Baseline|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
625988|NCT02717754|B1|Baseline|Placebo|Participants received oseltamivir matched placebo BID for 5 days.
625989|NCT02717754|P6|Participant Flow|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
625990|NCT02717754|P5|Participant Flow|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
625991|NCT02717754|P4|Participant Flow|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
625992|NCT02717754|P3|Participant Flow|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
625993|NCT02717754|P2|Participant Flow|Oseltamivir 100 mg|Participants received 100 milligrams (mg) oseltamivir intravenous BID for 5 days.
625994|NCT02717754|P1|Participant Flow|Placebo|Participants received oseltamivir matched placebo twice daily (BID) for 5 days.
625995|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
625996|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
625997|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
625998|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
625999|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626000|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626001|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626002|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626003|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626004|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626005|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626006|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626007|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626008|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626009|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626010|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626011|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626012|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626013|NCT02717754|O2|Outcome|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626014|NCT02717754|O1|Outcome|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626015|NCT02717754|E6|Reported Event|Oseltamivir 200 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 200 mg intravenous BID for 5 days but received incorrect infusion duration.
626016|NCT02717754|E5|Reported Event|Oseltamivir 100 mg (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir 100 mg intravenous BID for 5 days but received incorrect infusion duration.
626017|NCT02717754|E4|Reported Event|Placebo (Incorrect Infusion Duration)|Participants were randomized to receive oseltamivir matched placebo intravenous BID for 5 days but received incorrect infusion duration.
626018|NCT02717754|E3|Reported Event|Oseltamivir 200 mg|Participants received 200 mg oseltamivir intravenous BID for 5 days.
626019|NCT02717754|E2|Reported Event|Oseltamivir 100 mg|Participants received 100 mg oseltamivir intravenous BID for 5 days.
626020|NCT02717754|E1|Reported Event|Placebo|Participants received oseltamivir matched placebo for 5 days.
626021|NCT02716779|B4|Baseline|Total|Total of all reporting groups
626022|NCT02716779|B3|Baseline|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626023|NCT02716779|B2|Baseline|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626024|NCT02716779|B1|Baseline|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626025|NCT02716779|P3|Participant Flow|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626026|NCT02716779|P2|Participant Flow|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626027|NCT02716779|P1|Participant Flow|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626028|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626029|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626030|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626159|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626160|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626719|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626031|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626032|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626033|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626034|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626035|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626036|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626037|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626038|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626090|NCT02713594|P1|Participant Flow|Control|Participants in the Control condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
626720|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626039|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626040|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626041|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626042|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626043|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626044|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626045|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626046|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626142|NCT02708524|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626143|NCT02708524|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626144|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
629833|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
626047|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626048|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626049|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626050|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626051|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626052|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626053|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626054|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626145|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626146|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626147|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626055|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626056|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626057|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626058|NCT02716779|O3|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626059|NCT02716779|O2|Outcome|Placebo|"Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626060|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626061|NCT02716779|O3|Outcome|Total Participant Group|Combined group of PEG IFN alfa-2a, matching placebo and ribavirin arms.
626062|NCT02716779|O2|Outcome|Ribavirin|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626063|NCT02716779|O1|Outcome|Pegylated Interferon (PEG-IFN) Alfa-2a|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy."
626148|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626149|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626721|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626064|NCT02716779|E6|Reported Event|Ribavirin, Period 2 Combination Therapy|"In period 2 participants, who received ribavirin monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
626065|NCT02716779|E5|Reported Event|Placebo, Period 2 Combination Therapy|"In period 2 participants, who received placebo in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
626066|NCT02716779|E4|Reported Event|PEG-IFN Alfa-2a, Period 2 Combination Therapy|"In period 2 participants, who received PEG-IFN monotherapy in period 1, received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
626067|NCT02716779|E3|Reported Event|Ribavirin, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks in period 1.~Ribavirin: Ribavirin, 1000 mg PO (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks."
626068|NCT02716779|E2|Reported Event|Placebo, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received placebo PO for 6 weeks in period 1.~Placebo: Ribavirin matching placebo orally (PO) twice daily for 6 weeks."
626069|NCT02716779|E1|Reported Event|PEG-IFN Alfa-2a, Period 1 Monotherapy|"Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks in period 1.~Pegylated Interferon (PEG-IFN) alfa-2a: Pegylated Interferon (PEG-IFN) alfa-2a (40KD) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks."
626070|NCT02716298|B1|Baseline|Overall Participants|"Study participants are randomized to wear fanfilcon A lens or lotrafilcon B lens for 1 month during the crossover study~fanfilcon A: contact lens lotrafilcon B: contact lens"
626071|NCT02716298|P2|Participant Flow|Lotrafilcon B Then Fanfilcon A|"Study participants are randomized to wear lotrafilcon B for 1 month, then fanfilcon A lens for 1 month during the crossover study.~lotrafilcon B: contact lens fanfilcon A: contact lens"
626072|NCT02716298|P1|Participant Flow|Fanfilcon A Then Lotrafilcon B|"Study participants are randomized to wear fanfilcon A lens for 1 month, then lotrafilcon B for 1 month during the crossover study~fanfilcon A: contact lens lotrafilcon B: contact lens"
626073|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.~lotrafilcon B: contact lens"
626074|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
626075|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.~lotrafilcon B: contact lens"
626076|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
626077|NCT02716298|O5|Outcome|Strongly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study~lotrafilcon B: contact lens"
626078|NCT02716298|O4|Outcome|Slightly Prefer Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study~lotrafilcon B: contact lens"
626079|NCT02716298|O3|Outcome|No Preference|
626080|NCT02716298|O2|Outcome|Slightly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
626081|NCT02716298|O1|Outcome|Strongly Prefer Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
626082|NCT02716298|O2|Outcome|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens for 1 month during the crossover study.~lotrafilcon B: contact lens"
626083|NCT02716298|O1|Outcome|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens for 1 month during the crossover study~fanfilcon A: contact lens"
626084|NCT02716298|E2|Reported Event|Lotrafilcon B|"Study participants are randomized to wear lotrafilcon B lens during the crossover study.~lotrafilcon B: contact lens"
626085|NCT02716298|E1|Reported Event|Fanfilcon A|"Study participants are randomized to wear fanfilcon A lens during the crossover study~fanfilcon A: contact lens"
626086|NCT02713594|B3|Baseline|Total|Total of all reporting groups
626087|NCT02713594|B2|Baseline|Incentive|Counseling from WTQL; Financial incentive to participate
626088|NCT02713594|B1|Baseline|Control|Counseling from WTQL
626089|NCT02713594|P2|Participant Flow|Incentive|"Participants in the Incentive Condition received counseling from the Wisconsin Tobacco Quit Line (WTQL) consisting of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.~Participants in the Incentive condition also received financial incentives to complete proactive counseling calls from the WTQL received ($30 per completed call); in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit."
626150|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626091|NCT02713594|O2|Outcome|Incentive|"Counseling from WTQL; Financial incentive to participate~Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.~Financial incentive to participate: Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.)"
626092|NCT02713594|O1|Outcome|Control|"Counseling from WTQL~Counseling from WTQL: Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant’s initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking."
626093|NCT02713594|O2|Outcome|Incentive|Counseling from WTQL; Financial incentive to participate
626094|NCT02713594|O1|Outcome|Control|Counseling from WTQL
626095|NCT02713594|O2|Outcome|Incentive|Counseling from WTQL; Financial incentive to participate
626096|NCT02713594|O1|Outcome|Control|Counseling from WTQL
626097|NCT02713594|E2|Reported Event|Incentive|Counseling from WTQL; Financial incentive to participate
626098|NCT02713594|E1|Reported Event|Control|Counseling from WTQL
626099|NCT02712099|B3|Baseline|Total|Total of all reporting groups
626100|NCT02712099|B2|Baseline|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626101|NCT02712099|B1|Baseline|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626102|NCT02712099|P2|Participant Flow|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626103|NCT02712099|P1|Participant Flow|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626104|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626105|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626151|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626152|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626722|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626106|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626107|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626108|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626109|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626110|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626111|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626112|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626113|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626114|NCT02712099|O2|Outcome|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626115|NCT02712099|O1|Outcome|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626116|NCT02712099|E2|Reported Event|Women With Placenta Previa Who Had Difficult Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~When not separated easily manual removal was done, with uterotonics, together with uterine massage.~20 Women with placenta previa who had difficult placenta delivery"
626117|NCT02712099|E1|Reported Event|Women With Placenta Previa Who Had Easily Placenta Delivery|"This is a prospective study which will include 50 patients who will be selected from the outpatient and inpatient obstetric Ain Shams university maternity hospital.~• All patients will undergo the following : For each patient, the whole placenta will be scanned in a systematic fashion using both 2D grayscale and 2D power Doppler ultrasound then displayed by 3D TUI to determine whether those patients suspected of having advanced invasive placentation.~Intraoperative:~Delivery of the fetus through the placenta.~15 minutes for spontaneous separation of the placenta were waited, if easily separated hot packs then rapid closure of the uterus in 2 layers.~30 Women with placenta previa who had easily placenta delivery"
626118|NCT02709577|B3|Baseline|Total|Total of all reporting groups
626119|NCT02709577|B2|Baseline|Sham: Endoscopy and Standard of Care|"Subjects randomized to sham arm received an upper GI examination and were evaluated for study endpoints.~Sham: endoscopy and standard of care: Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes"
626120|NCT02709577|B1|Baseline|EndoBarrier Gastrointestinal Liner|"Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 weeks to 52 weeks and evaluated for study endpoints.~EndoBarrier Gastrointestinal Liner: The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum."
626121|NCT02709577|P4|Participant Flow|Cohort B Control Sham|Device not implanted.
626122|NCT02709577|P3|Participant Flow|Cohort A Control Sham|Device was not implanted
626123|NCT02709577|P2|Participant Flow|Cohort B:EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
626124|NCT02709577|P1|Participant Flow|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
626125|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was 12 months.
626126|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation. Follow-up after treatment phase was originally 6 months and then extended to 12 months based on physician discretion.
626127|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
626128|NCT02709577|O1|Outcome|Cohoart A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
626129|NCT02709577|O4|Outcome|Cohort B Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
626130|NCT02709577|O3|Outcome|Cohort A Control Sham: Endoscopy and Standard of Care|Subjects received only an upper GI endoscopic examination with no device implantation.
626131|NCT02709577|O2|Outcome|Cohort B: EndoBarrier Gastrointestinal Liner|Subjects in Cohort B had a 52 week implant period. Follow-up after device removal was originally 6 months and then extended to 12 months based on physician discretion.
626132|NCT02709577|O1|Outcome|Cohort A: EndoBarrier Gastrointestinal Liner|Subjects in Cohort A were implanted with the device for 24 weeks and given the option to continue for up to 52 weeks.
626133|NCT02709577|E2|Reported Event|Cohorts A and B Sham: Endoscopy and Standard of Care|Subjects randomized to sham and underwent an endoscopy procedure and then received standard of care treatment for their diabetes
626134|NCT02709577|E1|Reported Event|Cohorts A and B: EndoBarrier Gastrointestinal Liner|Subjects randomized and implanted with the EndoBarrier Gastrointestinal liner; subjects will be implanted for 24 or 52 weeks and evaluated for study endpoints
626135|NCT02708524|B5|Baseline|Total|Total of all reporting groups
626136|NCT02708524|B4|Baseline|Samfilcon A|All subjects that wore the samfilcon A lens throughout the duration of the study.
626137|NCT02708524|B3|Baseline|Lotrafilcon B|All subjects that wore the lotrafilcon B lens throughout the duration of the study.
626138|NCT02708524|B2|Baseline|Comfilcon A|All subjects that wore the comfilcon A lens throughout the duration of the study.
626139|NCT02708524|B1|Baseline|Senofilcon C|All subjects that wore the senofilcon C lens throughout the duration of the study.
626140|NCT02708524|P4|Participant Flow|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626141|NCT02708524|P3|Participant Flow|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
629834|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
626161|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626162|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626163|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626164|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626165|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626166|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626167|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626168|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626169|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626170|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626171|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626172|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626173|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626174|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626175|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626176|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626177|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626178|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626179|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626180|NCT02708524|O4|Outcome|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626181|NCT02708524|O3|Outcome|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626182|NCT02708524|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626183|NCT02708524|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626184|NCT02708524|E4|Reported Event|Samfilcon A|Subjects that were randomized to receive the samfilcon A lens throughout the duration of the study.
626185|NCT02708524|E3|Reported Event|Lotrafilcon B|Subjects that were randomized to receive the lotrafilcon B lens throughout the duration of the study.
626186|NCT02708524|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
626187|NCT02708524|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
626188|NCT02708355|B4|Baseline|Total|Total of all reporting groups
626189|NCT02708355|B3|Baseline|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
626190|NCT02708355|B2|Baseline|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
626191|NCT02708355|B1|Baseline|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
626192|NCT02708355|P3|Participant Flow|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
626193|NCT02708355|P2|Participant Flow|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
626194|NCT02708355|P1|Participant Flow|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
626195|NCT02708355|O3|Outcome|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
626196|NCT02708355|O2|Outcome|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
626197|NCT02708355|O1|Outcome|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
626198|NCT02708355|O3|Outcome|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
626199|NCT02708355|O2|Outcome|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
626200|NCT02708355|O1|Outcome|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
626201|NCT02708355|E3|Reported Event|Placebo|Placebo matched to esomeprazole capsules administered orally twice daily from Day 1 to 14.
626202|NCT02708355|E2|Reported Event|Esomeprazole 20 mg Once Daily + Placebo|Esomeprazole 20 mg capsule administered orally once daily in the morning and placebo matched to esomeprazole capsule once daily in the evening from Day 1 to 14.
626203|NCT02708355|E1|Reported Event|Esomeprazole 20 mg Twice Daily|Esomeprazole 20 milligram capsules administered orally twice daily from Day 1 to 14.
626204|NCT02708277|B3|Baseline|Total|Total of all reporting groups
626387|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
626205|NCT02708277|B2|Baseline|Group B|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
626206|NCT02708277|B1|Baseline|Group A|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
626207|NCT02708277|P2|Participant Flow|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
626208|NCT02708277|P1|Participant Flow|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
626209|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
626210|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
626211|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
626212|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
626213|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
626214|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
626215|NCT02708277|O2|Outcome|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
626216|NCT02708277|O1|Outcome|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
626217|NCT02708277|E2|Reported Event|Intrauterine Balloon Group|"At the end of the procedure the surgery an intrauterine balloon (Cook Medical) was placed in the uterine cavity.~intrauterine balloon (Cook Medical): The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device."
626218|NCT02708277|E1|Reported Event|Loop-shaped Intrauterine Device Group|"At the end of the procedure the surgery loop-shaped intrauterine contraceptive device (IUCD) was placed in the uterine cavity.~loop-shaped intrauterine contraceptive device: Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation."
626219|NCT02708238|B4|Baseline|Total|Total of all reporting groups
626220|NCT02708238|B3|Baseline|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
626221|NCT02708238|B2|Baseline|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
626222|NCT02708238|B1|Baseline|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
626223|NCT02708238|P3|Participant Flow|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
626467|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626224|NCT02708238|P2|Participant Flow|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
626225|NCT02708238|P1|Participant Flow|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
626226|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
626227|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
626228|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
626229|NCT02708238|O3|Outcome|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
626230|NCT02708238|O2|Outcome|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
626231|NCT02708238|O1|Outcome|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
626232|NCT02708238|E3|Reported Event|Group C|"All enrolled infants randomized to Group C will receive simethicone, given at a dose of 60 mg in 20 drops four times per day of a commercially available solution~Simethicone"
626233|NCT02708238|E2|Reported Event|Group B|"All enrolled infants randomized to Group B will receive Lactobacillus reuteri DSM 17938 administered at the dose of 108 colony-forming units (CFU)/day in 5 drops of a commercially available oil suspension~Lactobacillus reuteri DSM 17938 (108 CFU)"
626234|NCT02708238|E1|Reported Event|Group A|"All enrolled infants randomized to Group A will receive a standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized Lactobacillus Acidophilus (H122), administered at the dose of 1 ml twice a day of a commercially available solution~Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)"
626235|NCT02708212|B3|Baseline|Total|Total of all reporting groups
626236|NCT02708212|B2|Baseline|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
626237|NCT02708212|B1|Baseline|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received moderate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
626238|NCT02708212|P2|Participant Flow|Colonoscopy-EGD Group|In this study group, 60 patients received a colonoscopy followed by and an EGD during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insufflation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during EGD and colonoscopy examinations. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, were recorded. Recovery time to discharge was also recorded.
626239|NCT02708212|P1|Participant Flow|EGD-colonoscopy Group|In this study group, 60 patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients received modeate conscious sedation with fentanyl and midazolam and carbon dioxide insullfation. Interventions with cold forceps polypectomy, cold snare polypectomy or hot snare polypectomy were performed for gastric and/or colon polyps during endoscopy procedures. Patients' heart rate, respiratory rate, blood pressure, and oxygen saturation were recorded every 60 seconds during endoscopic examinations. Patients' tolerability to both endoscopy examinations was scaled by patients and endoscopists after examinations. Aldrete scores, at 15 minutes and 25 minutes after entering the recovery room, was recorded. Recovery time to discharge was also recorded.
626240|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|The duration of both colonoscopy and EGD examinations was recorded and compared.
626241|NCT02708212|O1|Outcome|EGD-colonoscopy Group|The duration of both EGD and colonoscopy examinations was recorded and compared.
626259|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626242|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
626243|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of midazolam after the completion of the bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
626244|NCT02708212|O2|Outcome|Colonoscopy-EGD Group|"In this group, patients received a colonoscopy followed by an EGD during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
626245|NCT02708212|O1|Outcome|EGD-colonoscopy Group|"In this group, patients received an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Moderate conscious sedation with fentanyl and midazolam was provided. The total doses of fentanyl after the completion of bidirectional endoscopy were recorded.~EGD and colonoscopy: Gastric polypectomy was provided when gastric polyps were found during an EGD study. Colon polypectomy was provided when colon polyps were found during a colonoscopy study."
626246|NCT02708212|E2|Reported Event|Colonoscopy-EGD Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
626247|NCT02708212|E1|Reported Event|EGD-colonoscopy Group|Patients received moderate conscious sedation with fentanyl and midazolam. Blood pressure, heart rate, and oxygen saturation were monitored and recorded during the endoscopic procedures. Supplemental oxygen (2 L/min) by nasal cannula was provided for every patient. The following adverse events were recorded during conscious sedation: 1) oxygen desaturation: < 90% persisting for more than 60 s; 2) hypotension: < 90 mm Hg systolic blood pressure for more than 60 s; 3) hypertension: > 180 mm Hg systolic blood pressure for more than 60 s; 4) tachycardia: > 120 beats per minute, lasting more than 60 s; and 5) bradycardia: < 50 beats per minute, lasting more than 60 s.
626248|NCT02707640|B3|Baseline|Total|Total of all reporting groups
626249|NCT02707640|B2|Baseline|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626250|NCT02707640|B1|Baseline|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626251|NCT02707640|P2|Participant Flow|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626252|NCT02707640|P1|Participant Flow|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626253|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626254|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626255|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626256|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626257|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626258|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626260|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626261|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626262|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626263|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626264|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626265|NCT02707640|O2|Outcome|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626266|NCT02707640|O1|Outcome|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626267|NCT02707640|E2|Reported Event|Placebo|Participants randomized to this arm were administered matching placebo orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626268|NCT02707640|E1|Reported Event|N–Acetylcysteine (NAC)|Participants randomized to this arm were administered 600 milligram (mg) NAC orally three times daily and a dose of pirfenidone of at least 1602 mg/day for 24 weeks. Participants were to be on a dose of pirfenidone of at least 1602 mg/day for a minimum of 8 weeks prior to randomization and were followed until 4 weeks after last study treatment dose.
626269|NCT02707172|B1|Baseline|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.~The placebo is handwashing with water using the 6-step standardized handwashing technique.~The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
626270|NCT02707172|P1|Participant Flow|All Participants|"All participants underwent two experiments, one with placebo (handwashing with water) and one with intervention (handwashing with soap), but in different order.~28 participants underwent placebo first and crossed-over to received intervention; while the other 28 participants underwent intervention first and then placebo. There was one day wash-out period between the two sets of experiment.~In each set of the experiment, each participant was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo or intervention by a standardized hand washing technique depending on the sequence assignment.~A total of 56 placebo experiments were performed and a total of 56 intervention experiments were performed in the study."
626271|NCT02707172|O1|Outcome|All Participants|"A total of 28 participants were recruited and were divided into two groups, one group receiving placebo first and then intervention, the other group receiving intervention first and then placebo.~The placebo is handwashing with water using the 6-step standardized handwashing technique.~The intervention is handwasahing with soap using the 6-step standardized handwashing technique."
626272|NCT02707172|E2|Reported Event|Placebo|"Subject was exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the placebo, handwashing with water, by a standardized hand washing technique.~Then the subjects in this arms are crossover to perform the intervention, handwashing with soap.~handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique~handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
626273|NCT02707172|E1|Reported Event|Intervention|"Subject was first exposed to 1000 microgram of diethylhexyl phthalate on both hands, and was asked to perform the intervention, handwashing with soap, by a standardized hand washing technique.~Then the subjects in this arms are crossover to receive placebo, handwashing with water only.~handwashing with soap: handwashing with soap by a standardized 6-step handwashing technique~handwashing with water: handwashing with water by a standardized 6-step handwashing technique"
626274|NCT02705807|B1|Baseline|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626275|NCT02705807|P1|Participant Flow|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626468|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626276|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626277|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626278|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626279|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626280|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626281|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626282|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626283|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626284|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626285|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626286|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626287|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626288|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626323|NCT02701556|O1|Outcome|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626723|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626289|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626290|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626291|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626292|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626293|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626294|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626295|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626296|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626297|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626298|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626299|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626300|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626301|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626324|NCT02701556|E2|Reported Event|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626724|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
626302|NCT02705807|O1|Outcome|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626303|NCT02705807|E1|Reported Event|FLOLAN With New Diluent|Japanese par. with pulmonary arterial hypertension (PAH) received FLOLAN prepared with the current marketed diluent (epoprostenol sodium + Potential of Hydrogen [pH] 10.2-10.8 diluent) for Injection in run-in period for a maximum of 30 days, and then switched to FLOLAN prepared with new diluent (epoprostenol sodium + pH 11.7-12.3 diluent) for Injection for 4-weeks in the treatment period. Par. received dose of 47.6 to 113.8 nanogram per kilogram per minute (ng/kg/min) during the treatment period.
626304|NCT02705716|B3|Baseline|Total|Total of all reporting groups
626305|NCT02705716|B2|Baseline|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626306|NCT02705716|B1|Baseline|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626307|NCT02705716|P2|Participant Flow|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626308|NCT02705716|P1|Participant Flow|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626309|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626310|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626311|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626312|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626313|NCT02705716|O2|Outcome|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626314|NCT02705716|O1|Outcome|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626315|NCT02705716|E2|Reported Event|Control Dentifrice|Participants were instructed to apply a full brush head of control dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants then brushed the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626316|NCT02705716|E1|Reported Event|Test Dentifrice|Participants were instructed to dose a dry toothbrush with a full strip of test dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants then brushed each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Participants were permitted to rinse with tap water after brushing.
626317|NCT02701556|B3|Baseline|Total|Total of all reporting groups
626318|NCT02701556|B2|Baseline|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626319|NCT02701556|B1|Baseline|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626320|NCT02701556|P2|Participant Flow|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626321|NCT02701556|P1|Participant Flow|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626322|NCT02701556|O2|Outcome|COMPLETE Multi-Purpose Solution|"B&L Multi-Purpose Solution as a rub care regimen (Control)~Complete Multi-Purpose Solution: a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626325|NCT02701556|E1|Reported Event|Bausch & Lomb Investigational NNR06 Multi-Purpose Solution|"B & L investigational NNR06 used as a rub care regimen (Test)~NNR06: an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses."
626326|NCT02701387|B1|Baseline|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
626327|NCT02701387|P1|Participant Flow|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
626328|NCT02701387|O2|Outcome|EZ Plus Implant|"Comparative implant (Megagen EZ Plus dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen EZ Plus dental implant: EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market."
626329|NCT02701387|O1|Outcome|AnyRidge Implant|"Experimental implant (Megagen AnyRidge dental implant) placed in a healed edentulous site to replace a missing tooth.~Megagen AnyRidge dental implant: AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth)."
626330|NCT02701387|E1|Reported Event|All Participants|Patients presenting to the study site in need of at least two dental implants received one of each implant type: Easy (EZ) Plus and AnyRidge (AR).
626331|NCT02701296|B3|Baseline|Total|Total of all reporting groups
626332|NCT02701296|B2|Baseline|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626333|NCT02701296|B1|Baseline|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626334|NCT02701296|P2|Participant Flow|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626335|NCT02701296|P1|Participant Flow|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626336|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626337|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626338|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626339|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626340|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626341|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626342|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626343|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626344|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626345|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626346|NCT02701296|O2|Outcome|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626347|NCT02701296|O1|Outcome|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626348|NCT02701296|E2|Reported Event|Tibial Nerve Block|"Ultrasound selective tibial nerve block of ropivacaine~Ropivacaine: Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa"
626349|NCT02701296|E1|Reported Event|Posterior Capsular Injection|"Ultrasound guided posterior capsular injection of ropivacaine with epinephrine~Ropivacaine with Epinephrine: Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles"
626350|NCT02701270|B1|Baseline|All Study Participants|All participants received every study intervention in randomized order: Experimental Dietary Fibre 1 and 2, Polydextrose and Dextrose
626351|NCT02701270|P4|Participant Flow|Fibre 2 First, Then Polydextrose, Dextrose and Fibre1|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Dietary Fibre 2, at second visit 21.48 g Polydextrose Control, at third visit 23.89 g Dextrose Control and at fourth visit 22.17 g Dietary Fibre 1.
626352|NCT02701270|P3|Participant Flow|Fibre1 First, Then Fibre 2, Polydextrose and Dextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 22.17 g Dietary Fibre 1, at second visit 21.48 g Dietary Fibre 2, at third visit 21.48 g Polydextrose Control and at fourth visit 23.89 g Dextrose Control.
626353|NCT02701270|P2|Participant Flow|Dextrose First, Then Fibre1, Fibre 2 and Polydextrose|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 23.89 g Dextrose Control, at second visit 22.17 g Dietary Fibre 1, at third visit 21.48 g Dietary Fibre 2 and at fourth visit 21.48 g Polydextrose Control.
626354|NCT02701270|P1|Participant Flow|Polydextrose First, Then Dextrose, Fibre1 and Fibre 2|Participant received study products at 4 visits, always diluted in 250 ml of water. Minimum washout period was 48 hours between consecutive visits. At first visit participant received 21.48 g Polydextrose Control, at second visit 23.89 g Dextrose Control, at third visit 22.17 g Dietary Fibre 1 and at fourth visit 21.48 g Dietary Fibre 2.
626355|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
626356|NCT02701270|O3|Outcome|Polydextrose|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
626357|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
626358|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
626359|NCT02701270|O4|Outcome|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
626360|NCT02701270|O3|Outcome|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
626361|NCT02701270|O2|Outcome|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
626362|NCT02701270|O1|Outcome|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
626363|NCT02701270|E4|Reported Event|Dextrose Control|Dextrose: 23.89 g of dextrose diluted in 250 ml of water taken once orally.
626364|NCT02701270|E3|Reported Event|Polydextrose Control|Polydextrose: 21.48 g of product diluted in 250 ml of water taken once orally.
626365|NCT02701270|E2|Reported Event|Experimental Dietary Fibre 2|Experimental Dietary Fibre 2: 21.84 g of product diluted in 250 ml of water taken once orally.
626366|NCT02701270|E1|Reported Event|Experimental Dietary Fibre 1|Experimental Dietary Fibre 1: 22.17 g of product diluted in 250 ml of water taken once orally.
626367|NCT02699892|B1|Baseline|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
626368|NCT02699892|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
626369|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
626370|NCT02699892|O1|Outcome|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
626371|NCT02699892|E1|Reported Event|Rheumatoid Arthritis Participants|Participants who were on rituximab for rheumatoid arthritis and who continued receiving rituximab treatment (at the discretion of treating physician) according to approved label were observed for a period of 72 weeks.
626372|NCT02699593|B1|Baseline|Dispensed Subjects|
626373|NCT02699593|P2|Participant Flow|Senofilcon A(Control)/Senofilcon A(Test)|Subjects that were randomized to receive the control lens senofilcon A first and then the test lens senofilcon A lens second.
626374|NCT02699593|P1|Participant Flow|Senofilcon A(Test)/Senofilcon A(Control)|Subjects that were randomized to receive the test lens senofilcon A lens first and then the control lens senofilcon A lens second.
626375|NCT02699593|O2|Outcome|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
626376|NCT02699593|O1|Outcome|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
626377|NCT02699593|O2|Outcome|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A lens during the first or second period of the study.
626378|NCT02699593|O1|Outcome|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A during either the first or second period of the study.
626379|NCT02699593|E2|Reported Event|Senofilcon A (Control)|Subjects that wore the control lens senofilcon A in either the first or second period of the study.
626380|NCT02699593|E1|Reported Event|Senofilcon A (Test)|Subjects that wore the test lens senofilcon A in either the first or second period of the study.
626381|NCT02697890|B3|Baseline|Total|Total of all reporting groups
626382|NCT02697890|B2|Baseline|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
626383|NCT02697890|B1|Baseline|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
626384|NCT02697890|P2|Participant Flow|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
626385|NCT02697890|P1|Participant Flow|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
626386|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
629835|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
626388|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
626389|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
626390|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
626391|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
626392|NCT02697890|O2|Outcome|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
626393|NCT02697890|O1|Outcome|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
626394|NCT02697890|E2|Reported Event|FDBA (MinerOss®) + Mucograft® Seal|"Interventions:~Device: Mucograft® seal Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Mucograft® seal: Collagen matrix membrane for soft-tissue regeneration"
626395|NCT02697890|E1|Reported Event|FDBA(MinerOss®) + Collagen Sponge(HeliPLUG®)|"Interventions:~Procedure: Ridge preservation procedure~FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®): Standard of Care"
626396|NCT02694718|B1|Baseline|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626397|NCT02694718|P1|Participant Flow|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 milligrams per square meter (mg/m^2) on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 twice a day (bid) orally, along with oxaliplatin as a 2-hour intravenous (iv) infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 gray (Gy)/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626398|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626399|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626400|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626401|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626402|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626403|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626404|NCT02694718|O1|Outcome|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626405|NCT02694718|E1|Reported Event|Capecitabine + Oxaliplatin|Eligible participants received capecitabine 1000 mg/m^2 on Days 1-14, and 825 mg/m^2 on Days 22-35 and 43-56 bid orally, along with oxaliplatin as a 2-hour iv infusion of 130 mg/m^2/once a day (d) on Day 1 and 50 mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy. Participants received radiation therapy having a fraction dose of 1.8 Gy/day, 5 days a week, for five consecutive weeks starting on Day 22 of the treatment period. Participants, who completed the treatment period, underwent surgery at Week 14.
626406|NCT02694536|B1|Baseline|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626407|NCT02694536|P1|Participant Flow|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 milligrams (mg) orally (PO) once daily. Gemcitabine was administered as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626408|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626409|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626410|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626411|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626412|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626413|NCT02694536|O1|Outcome|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626414|NCT02694536|E1|Reported Event|Erlotinib + Gemcitabine|Participants with locally advanced, unresectable, or metastatic pancreatic cancer received erlotinib in combination with standard of care chemotherapy (gemcitabine) until disease progression, unacceptable toxicity, or withdrawal for any reason. Erlotinib was administered as 100 mg PO once daily. Gemcitabine was administered as 1000 mg/m^2 via IV infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
626415|NCT02694315|B1|Baseline|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
626416|NCT02694315|P1|Participant Flow|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
626417|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
626418|NCT02694315|O1|Outcome|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
626419|NCT02694315|E1|Reported Event|Induction of Labor|"200 women all are primigravida between 37-42 weeks gestation to whom induction of labor will be carried out in the casualty of Ain Shams University Maternity Hospital. All participants will have an assessment of the cervix by both Bishop score system and transvaginal measurement of cervical length.~Bishop score: calculation of modified Bishop score in numbers by digital vaginal examination~cervical length: measuring cervical length by trans-vaginal ultrasound"
626469|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626420|NCT02694198|B1|Baseline|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
626421|NCT02694198|P1|Participant Flow|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
626422|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
626423|NCT02694198|O1|Outcome|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
626424|NCT02694198|E1|Reported Event|Mid-trimester Abortion|The population of the study comprised 135 pregnant women attending Ain Shams University Maternity hospital at labor and delivery ward diagnosed with mid-trimester missed miscarriage confirmed by transabdominal ultrasound who will undergo termination by misoprostol
626425|NCT02693704|B5|Baseline|Total|Total of all reporting groups
626426|NCT02693704|B4|Baseline|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626427|NCT02693704|B3|Baseline|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626428|NCT02693704|B2|Baseline|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626429|NCT02693704|B1|Baseline|Normal Hearing|People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.
626430|NCT02693704|P4|Participant Flow|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626431|NCT02693704|P3|Participant Flow|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626432|NCT02693704|P2|Participant Flow|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626433|NCT02693704|P1|Participant Flow|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
626470|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626471|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
629836|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
626434|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626435|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626436|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626437|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
626438|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626439|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626440|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626441|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
626442|NCT02693704|O4|Outcome|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626443|NCT02693704|O3|Outcome|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626472|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626444|NCT02693704|O2|Outcome|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626445|NCT02693704|O1|Outcome|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
626446|NCT02693704|E4|Reported Event|Profound Hearing Impaired|"Patients showing profound hearing loss (> 80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626447|NCT02693704|E3|Reported Event|Severe Hearing Impaired|"Patients showing severe hearing loss (60-80 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626448|NCT02693704|E2|Reported Event|Moderate Hearing Impaired|"Patients showing moderate hearing loss (40-60 dB HL).~Introduction of speech signal via the DAI of two hearing aids among:~PhonakAudéo V-13 Phonak Baseo Q-P, Q-SP, Q-M13 Phonak Bolero Q-P, Q-SP, Q-M13, Boléro V-P, V-SP Phonak Naida Q-CRT, Q-SP, Q-UP Phonak Sky Q-RIC, Q-SP, Q-UP, Q-M13 Phonak Ambra microP, SP, M H20 Phonak Cassia microP, SP, M H20 Phonak Dalia microP, SP, M H20 Phonak Naida S SP, S UP, S CRT Phonak Solana microP, SP, M H20 Phonak Certéna micro, Art M, Art P, Art SP, Art micro Phonak Exélia micro, Art M, Art P, Art SP, Art micro Phonak Milo Plus micro, Plus SP, Plus UP Phonak Naida SP, SP Junior, UP, UP Junior Phonak Nios micro, S H20 Phonak Versata micro, Art M, Art P, Art SP, Art micro"
626449|NCT02693704|E1|Reported Event|Normal Hearing|"People showing no hearing loss (< 20 dB HL). Introduction of speech signal via the DAI of two hearing aids Phonak Naida IX SP.~Hearing Aids: The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment."
626450|NCT02691507|B3|Baseline|Total|Total of all reporting groups
626451|NCT02691507|B2|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626452|NCT02691507|B1|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626453|NCT02691507|P2|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626454|NCT02691507|P1|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626455|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626456|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626457|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626458|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626459|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626460|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626461|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626462|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626463|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626464|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626465|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626466|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626658|NCT02684942|O1|Outcome|Meperidine|Analyze in meperidine group.
626473|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626474|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626475|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626476|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626477|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626478|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626479|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626480|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626481|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626482|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626483|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626484|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626485|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626486|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626487|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626488|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626489|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626490|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626491|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626492|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626493|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626494|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626495|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626496|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626497|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626498|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626499|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626500|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626501|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626502|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626503|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626504|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626505|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626506|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626507|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626508|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626509|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626510|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626511|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626512|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626659|NCT02684942|O2|Outcome|Fentanyl|Separate analyze in fraction that patient received fentanyl.
626513|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626514|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626515|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626516|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626517|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626518|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626519|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626520|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626521|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626522|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626523|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626524|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626525|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626526|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626527|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626528|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626529|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626530|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626531|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626532|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626533|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626534|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626535|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626536|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626537|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626538|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626539|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626540|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626541|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626542|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626543|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626544|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626545|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626546|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626547|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626548|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626549|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626550|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626551|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626552|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626660|NCT02684942|O1|Outcome|Meperidine|Separate analyze in fraction that patient receive meperidine.
626553|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626554|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626555|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626556|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626557|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626558|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626559|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626560|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626561|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626562|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626563|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626564|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626565|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626566|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626567|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626568|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626569|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626570|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626571|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626572|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626573|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626574|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626575|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626576|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626577|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626578|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626579|NCT02691507|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626580|NCT02691507|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626581|NCT02691507|E2|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day (or as needed)
626582|NCT02691507|E1|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once per day (or as needed)
626583|NCT02691416|B3|Baseline|Total|Total of all reporting groups
626584|NCT02691416|B2|Baseline|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626585|NCT02691416|B1|Baseline|Propofol Postconditioning|1.2ug/ml propofol Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
626586|NCT02691416|P2|Participant Flow|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626587|NCT02691416|P1|Participant Flow|Propofol Postconditioning|Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately.
626588|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626589|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
626590|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626591|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal"
626592|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
629837|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
626593|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
626594|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626595|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
626596|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626597|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
626598|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626599|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately"
626600|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626601|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/mL propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
626602|NCT02691416|O2|Outcome|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626603|NCT02691416|O1|Outcome|Propofol Postconditioning|"1.2ug/ml propofol~propofol: Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
626604|NCT02691416|E2|Reported Event|Sevoflurane|"0.5%-2% sevoflurane~sevoflurane: 0.5%-2% sevoflurane with BIS 40-60"
626605|NCT02691416|E1|Reported Event|Propofol Postconditioning|"1.2ug/mL propofol~propofol:Group propofol postconditioning was administrated TCI of propofol (Cp 1.2ug/ml) and decreased sevoflurane concentration with a BIS value of 40-60 to maintain anesthesia after clamp removal immediately."
626606|NCT02691143|B3|Baseline|Total|Total of all reporting groups
626607|NCT02691143|B2|Baseline|Manipulation Only|The control group received manipulation from a licensed chiropractor only
626608|NCT02691143|B1|Baseline|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
626609|NCT02691143|P2|Participant Flow|Manipulation Only|The control group received manipulation from a licensed chiropractor only
626610|NCT02691143|P1|Participant Flow|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
626611|NCT02691143|O2|Outcome|Manipulation Only|The control group received manipulation from a licensed chiropractor only
626612|NCT02691143|O1|Outcome|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
626613|NCT02691143|O2|Outcome|Manipulation Only|The control group received manipulation from a licensed chiropractor only
626614|NCT02691143|O1|Outcome|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
626615|NCT02691143|E2|Reported Event|Manipulation Only|The control group received manipulation from a licensed chiropractor only
626616|NCT02691143|E1|Reported Event|Manipulation Plus Tape|The Tape Group had TheraBand® Kinesiology Tape, an elastic therapeutic tape (ETT), applied immediately following cervical manipulation from a licensed chiropractor. The taping protocol was applied by the investigator and consist of a “Y” strip applied at 25% tension running superior to inferior from the hair line to T1-2 and a horizontal “I” strip applied at 50% tension at the site of pain.
626617|NCT02690727|B1|Baseline|RP6530 in Fasting and Fed Conditions|"A single dose of RP6530 following fasting and Fed condition~RP6530: Single oral dose"
626618|NCT02690727|P2|Participant Flow|RP6530 in Fed Condition|"Fed Condition first, then Fast Condition...~RP6530: Single oral dose"
626619|NCT02690727|P1|Participant Flow|RP6530 in Fast Condition|"Fast Condition first, then Fed Condition~RP6530: Single oral dose"
626620|NCT02690727|O2|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
626621|NCT02690727|O1|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
626622|NCT02690727|O2|Outcome|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
626623|NCT02690727|O1|Outcome|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
626624|NCT02690727|E2|Reported Event|RP6530 in Fed Condition|"A single dose of RP6530 following fed condition~RP6530: Single oral dose"
626625|NCT02690727|E1|Reported Event|RP6530 in Fast Condition|"A single dose of RP6530 following fast condition~RP6530: Single oral dose"
626626|NCT02687217|B3|Baseline|Total|Total of all reporting groups
626661|NCT02684942|O2|Outcome|Fentanyl|Separate analysis in fentanyl group.
626627|NCT02687217|B2|Baseline|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
626628|NCT02687217|B1|Baseline|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
626629|NCT02687217|P2|Participant Flow|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
626630|NCT02687217|P1|Participant Flow|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
626631|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
626632|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
626633|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
626634|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
626635|NCT02687217|O2|Outcome|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
626636|NCT02687217|O1|Outcome|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
626637|NCT02687217|E2|Reported Event|Group B: Test|"Group B: Test- Received hyperoxygenation more than or equal to 50% throughout the surgery and received oxygen at 6l/min. upto 2 hrs postoperatively.~oxygen: Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
626638|NCT02687217|E1|Reported Event|Group A: Control|Group A: Control- Received no supplemental oxygen throughout the surgery and received oxygen at 4l/min. in 2hrs postoperatively
626639|NCT02687126|B1|Baseline|Demographic Variables|gender, age, weight, height, cross sectional area, body surface area
626640|NCT02687126|P1|Participant Flow|Ultrasound Guided Central Venous Catheterization|Six month study of ultrasound guided internal jugular venous catheterization in pediatric cardiac surgical patients
626641|NCT02687126|O1|Outcome|Correlation|Correlation of cross sectional area of internal jugular vein with number of attempts, time taken for successful cannulation and complication rate
626642|NCT02687126|O1|Outcome|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
626643|NCT02687126|O1|Outcome|Time to Successful Cannulation|Time taken in seconds from skin prick to aspiration of blood from catheter
626644|NCT02687126|O1|Outcome|Number of Attempts|An attempt is considered unsuccessful if complete withdrawal of the puncture needle out of skin occurs
626645|NCT02687126|E1|Reported Event|Number of Complications|Complications were defined as arterial puncture, hemothorax, pneumothorax and local site hematoma
626646|NCT02684942|B1|Baseline|All Participants|All participants who enrolled to this study.
626647|NCT02684942|P6|Participant Flow|Fentanyl,Meperidine,Meperidine,Fentanyl|"First and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
626648|NCT02684942|P5|Participant Flow|Meperidine,Fentanyl,Fentanyl,Meperidine|"First and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Third Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
626649|NCT02684942|P4|Participant Flow|Fentanyl,Fentanyl,Meperidine,Meperidine|"First and Second Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Third and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
626650|NCT02684942|P3|Participant Flow|Meperidine,Meperidine,Fentanyl,Fentanyl|"First and Second Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Third and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
626651|NCT02684942|P2|Participant Flow|Fentanyl,Meperidine,Fentanyl,Meperidine|"First and Third Intervention inject inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Fourth Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
626652|NCT02684942|P1|Participant Flow|Meperidine,Fentanyl,Meperidine,Fentanyl|"First and Third Intervention inject meperidine 1 mg./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4.~Second and Fourth Intervention inject fentanyl 1 ug./kg. to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4."
626653|NCT02684942|O1|Outcome|Fentanyl|Analyze in fentanyl group.
626654|NCT02684942|O1|Outcome|Meperidine|Analyze in meperidine group.
626655|NCT02684942|O2|Outcome|Fentanyl|Separate analyze in fraction that patient received fentanyl.
626656|NCT02684942|O1|Outcome|Meperidine|Separate analyze in fraction that patient receive meperidine.
626657|NCT02684942|O2|Outcome|Fentanyl|Analyze in fentanyl group.
626666|NCT02684630|B2|Baseline|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
626667|NCT02684630|B1|Baseline|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
626668|NCT02684630|P2|Participant Flow|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
626669|NCT02684630|P1|Participant Flow|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
626670|NCT02684630|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
626671|NCT02684630|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel System.~Trima Accel System: Platelet Apheresis Procedure"
626672|NCT02684630|O2|Outcome|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
626673|NCT02684630|O1|Outcome|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
626674|NCT02684630|E2|Reported Event|Double Platelet Product|"Healthy adult volunteer blood donors that qualify for a double unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
626675|NCT02684630|E1|Reported Event|Single Platelet Product|"Healthy adult volunteer blood donors that qualify for a single unit platelet collection, with or without other components, will undergo plateletpheresis on the Trima Accel® Automated Blood Collection System (Trima Accel System).~Trima Accel System: Platelet Apheresis Procedure"
626676|NCT02684604|B3|Baseline|Total|Total of all reporting groups
626677|NCT02684604|B2|Baseline|Fertile Women|44 fertile women
626678|NCT02684604|B1|Baseline|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
626679|NCT02684604|P2|Participant Flow|Fertile Women|44 fertile women
626680|NCT02684604|P1|Participant Flow|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
626681|NCT02684604|O2|Outcome|Fertile Women|44 fertile women
626682|NCT02684604|O1|Outcome|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
626683|NCT02684604|E2|Reported Event|Fertile Women|44 fertile women
626684|NCT02684604|E1|Reported Event|Unexplained Infertility Patients|44 patients diagnosed to have unexplained infertility
626685|NCT02684396|B7|Baseline|Total|Total of all reporting groups
626686|NCT02684396|B6|Baseline|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
626687|NCT02684396|B5|Baseline|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626688|NCT02684396|B4|Baseline|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626689|NCT02684396|B3|Baseline|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626690|NCT02684396|B2|Baseline|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626691|NCT02684396|B1|Baseline|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626692|NCT02684396|P6|Participant Flow|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
626693|NCT02684396|P5|Participant Flow|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626694|NCT02684396|P4|Participant Flow|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626695|NCT02684396|P3|Participant Flow|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626696|NCT02684396|P2|Participant Flow|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626697|NCT02684396|P1|Participant Flow|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626698|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626699|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626700|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626701|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626702|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626703|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626704|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626705|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626706|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626707|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626708|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626709|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626710|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626711|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
629838|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
626725|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626726|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626727|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626728|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626729|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626730|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
626731|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626732|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626733|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626734|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626735|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626736|NCT02684396|O6|Outcome|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
626737|NCT02684396|O5|Outcome|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626738|NCT02684396|O4|Outcome|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626739|NCT02684396|O3|Outcome|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626740|NCT02684396|O2|Outcome|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626741|NCT02684396|O1|Outcome|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626742|NCT02684396|E6|Reported Event|Cohort 1-5: Placebo|TAK-648 placebo-matching solution, orally, once on Day 1.
626743|NCT02684396|E5|Reported Event|Cohort 5: TAK-648 0.85 mg|TAK-648 0.85 mg, solution, orally, once on Day 1.
626744|NCT02684396|E4|Reported Event|Cohort 4: TAK-648 0.7 mg|TAK-648 0.7 mg, solution, orally, once on Day 1.
626745|NCT02684396|E3|Reported Event|Cohort 3: TAK-648 0.35 mg|TAK-648 0.35 mg, solution, orally, once on Day 1.
626746|NCT02684396|E2|Reported Event|Cohort 2: TAK-648 0.15 mg|TAK-648 0.15 mg, solution, orally, once on Day 1.
626747|NCT02684396|E1|Reported Event|Cohort 1: TAK-648 0.05 mg|TAK-648 0.05 mg, solution, orally, once on Day 1.
626748|NCT02683954|B3|Baseline|Total|Total of all reporting groups
626749|NCT02683954|B2|Baseline|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626750|NCT02683954|B1|Baseline|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626751|NCT02683954|P2|Participant Flow|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626752|NCT02683954|P1|Participant Flow|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626753|NCT02683954|O2|Outcome|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626754|NCT02683954|O1|Outcome|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626755|NCT02683954|E2|Reported Event|Control|30 women without any laparoscopically detected pelvic endometriotic pathology. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626756|NCT02683954|E1|Reported Event|Endometriosis|30 women with laparoscopically diagnosed endometriosis. This group will be categorized into 3 sub-groups according to the BMI: i) Lean: BMI <25.0 kg/m2. ii) Overweight: BMI ≥25.0 kg/m2 but less than 30 kg/m2. iii) Obese: BMI ≥30 kg/m2.
626757|NCT02681458|B3|Baseline|Total|Total of all reporting groups
626758|NCT02681458|B2|Baseline|Non-drug Users|"Control group that consisted of non drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626759|NCT02681458|B1|Baseline|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626760|NCT02681458|P2|Participant Flow|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626761|NCT02681458|P1|Participant Flow|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626762|NCT02681458|O2|Outcome|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626763|NCT02681458|O1|Outcome|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626764|NCT02681458|E2|Reported Event|Non-drug Users|"Control group that consisted of non-drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626765|NCT02681458|E1|Reported Event|Drug Users|"Case group that consisted of drug users with fungal infections~Direct Examination: It was an observational study and subjects received their routine treatment."
626766|NCT02679976|B1|Baseline|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626767|NCT02679976|P1|Participant Flow|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626768|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626769|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626770|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626771|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626772|NCT02679976|O2|Outcome|Etafilcon A (Multi-focal)- Myopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626773|NCT02679976|O1|Outcome|Etafilcon A (Multi-focal)- Hyperopes|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626774|NCT02679976|E1|Reported Event|Etafilcon A (Multi-focal)|All subjects wore etafilcon A(multi-focal) during the study. Subjects were stratified as either Myopes or Hyperopes based on their sphere power.
626775|NCT02679469|B1|Baseline|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
626776|NCT02679469|P1|Participant Flow|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
626777|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
626778|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
626779|NCT02679469|O1|Outcome|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
626780|NCT02679469|E1|Reported Event|Nalmefene Hydrochloride 10 mg|"nalmefene 10 mg tablet~nalmefene hydrochloride 10 mg"
626781|NCT02678676|B3|Baseline|Total|Total of all reporting groups
626782|NCT02678676|B2|Baseline|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
626783|NCT02678676|B1|Baseline|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
626784|NCT02678676|P2|Participant Flow|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
626785|NCT02678676|P1|Participant Flow|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
626786|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
626787|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
626788|NCT02678676|O2|Outcome|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
626789|NCT02678676|O1|Outcome|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
626790|NCT02678676|E2|Reported Event|Placebo|Participants who were previously treated with placebo-matching pioglitazone tablets, orally, once daily during the PROactive (NCT00174993) study were followed up to 10 years.
626791|NCT02678676|E1|Reported Event|Pioglitazone|Participants who were previously treated with pioglitazone 15, 30, or 45 milligram tablets, orally, once daily during the PROactive study (NCT00174993) were followed up to 10 years in this observational study.
626792|NCT02677779|B3|Baseline|Total|Total of all reporting groups
626793|NCT02677779|B2|Baseline|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626794|NCT02677779|B1|Baseline|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
626795|NCT02677779|P2|Participant Flow|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626796|NCT02677779|P1|Participant Flow|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
626797|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626798|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
626799|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626800|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
626801|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626802|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
626803|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626804|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
629839|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
626805|NCT02677779|O2|Outcome|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626806|NCT02677779|O1|Outcome|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
626807|NCT02677779|E2|Reported Event|Traditional Surgery|"Ulcer debridement with traditional surgery~traditional surgery: Single session of traditional debridement"
626808|NCT02677779|E1|Reported Event|CO2 Laser|"Ulcer debridement with laser-CO2 (DEKA SmartXide2 c80-El.En, Florence Italy)~CO2 laser: Single session of CO2 laser debridement"
626809|NCT02677493|B4|Baseline|Total|Total of all reporting groups
626810|NCT02677493|B3|Baseline|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626811|NCT02677493|B2|Baseline|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
626812|NCT02677493|B1|Baseline|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626813|NCT02677493|P3|Participant Flow|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626814|NCT02677493|P2|Participant Flow|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
626815|NCT02677493|P1|Participant Flow|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626816|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626817|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
626818|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626819|NCT02677493|O3|Outcome|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626820|NCT02677493|O2|Outcome|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
626821|NCT02677493|O1|Outcome|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626822|NCT02677493|E3|Reported Event|IL-YANG Trivalent Influenza Vaccine|"This TIV is included the B/Victoria strain.~IL-YANG Trivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626823|NCT02677493|E2|Reported Event|IL-YANG Flu Vaccine Prefilled Syringe|"This TIV is included the B/Yamagata strain, and it was approved for commercial sale by MFDS.~IL-YANG Flu Vaccine Prefilled Syringe: A single 0.5mL dose administrated as an intramuscular injection."
626824|NCT02677493|E1|Reported Event|IL-YANG Quadrivalent Influenza Vaccine|"The QIV is included both B strain (Yamagata, Victoria).~IL-YANG Quadrivalent Influenza Vaccine: A single 0.5mL dose administrated as an intramuscular injection."
626825|NCT02675543|B3|Baseline|Total|Total of all reporting groups
626826|NCT02675543|B2|Baseline|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
626827|NCT02675543|B1|Baseline|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
626828|NCT02675543|P2|Participant Flow|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
626829|NCT02675543|P1|Participant Flow|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
626830|NCT02675543|O2|Outcome|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
626831|NCT02675543|O1|Outcome|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
626832|NCT02675543|E2|Reported Event|Heavy Silicone Oil|"after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68)~Vitreous Tamponade with Silicone Oil"
626833|NCT02675543|E1|Reported Event|Standard Silicone Oil|"after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS)~Vitreous Tamponade with Silicone Oil"
626834|NCT02673944|B1|Baseline|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
626835|NCT02673944|P1|Participant Flow|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
626836|NCT02673944|O2|Outcome|Standard Urodynamic Analyzer|Patients will undergo a routine urodynamic evaluation, which will collect both Peritorn+ and UDS data.
626837|NCT02673944|O1|Outcome|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
626850|NCT02670811|B1|Baseline|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626838|NCT02673944|E1|Reported Event|Peritron+|"Patients will undergo a routine urodynamic evaluation, the Peritron+ will be used in conjunction with a water-based urodynamic catheter~Peritron+: Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure"
626839|NCT02672514|B3|Baseline|Total|Total of all reporting groups
626840|NCT02672514|B2|Baseline|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
626841|NCT02672514|B1|Baseline|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
626842|NCT02672514|P2|Participant Flow|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
626843|NCT02672514|P1|Participant Flow|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
626844|NCT02672514|O2|Outcome|Group A|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
626845|NCT02672514|O1|Outcome|Group B|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
626846|NCT02672514|E2|Reported Event|CECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the conventional extracorporeal circulation system (CECC). The CECC is an opened circulation system. The basic elements are a membrane oxygenator, a centrifugal pump, an open perfusion system containing the venous hard shell cardiotomy reservoir and the arterial line filter.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation, leading to a reduction of the priming volume. The CECC flow was set as required in order to maintain a mean arterial pressure (MAP) between 50 and 75 mmHg.~Conventional extracorporeal circulation (CECC): Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass."
626847|NCT02672514|E1|Reported Event|MiECC|"Coronary artery bypass grafting is used with the help of cardiopulmonary bypass (CPB). The technique used in this arm based on the minimally invasive extracorporeal circulation system (MiECC). MiECC has been developed based on the concept of a closed total CPB circuit. The basic elements are a centrifugal pump, a membrane oxygenator and an arterial filter. The priming volume compared to CECC could be reduced. The complete circuit is heparin-coated for maximizing the biocompatibility.~CPB was performed under normothermic conditions of 36°C. Retrograde autologous priming was performed for all patients with stable hemodynamic circulation.~Minimally invasive extracorporeal circulation (MiECC): Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass."
626848|NCT02670811|B3|Baseline|Total|Total of all reporting groups
626849|NCT02670811|B2|Baseline|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626851|NCT02670811|P2|Participant Flow|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626852|NCT02670811|P1|Participant Flow|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626853|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626854|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626855|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626856|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626857|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626858|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626859|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626860|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626861|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626862|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626863|NCT02670811|O2|Outcome|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626864|NCT02670811|O1|Outcome|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626865|NCT02670811|E2|Reported Event|Placebo|"Daily consumption of 150 mL of artificially acidified milk~Acidified milk: 150 mL daily of artificially acidified milk"
626866|NCT02670811|E1|Reported Event|Intervention|"Daily consumption of 150 mL of fermented milk with Lactococcus lactis for 8 weeks~Fermented milk: 150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571"
626867|NCT02670473|B1|Baseline|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
626868|NCT02670473|P1|Participant Flow|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
626869|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626870|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626871|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626872|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626873|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626874|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626875|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626876|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626877|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626878|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626879|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626880|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626881|NCT02670473|O2|Outcome|Fanfilcon A Lens (Test)|fanfilcon A lens (test)
626882|NCT02670473|O1|Outcome|Habitual Lenses|enfilcon A habitual lens (control)
626883|NCT02670473|O4|Outcome|Completely Dissatisfied|
626884|NCT02670473|O3|Outcome|Somewhat Dissatisfied|
626885|NCT02670473|O2|Outcome|Somewhat Satisfied|
626886|NCT02670473|O1|Outcome|Completely Satisfied|
626887|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626888|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626889|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626890|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626891|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626892|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626893|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626894|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626895|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626896|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626897|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626898|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626899|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626900|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626901|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626902|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626903|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626904|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626905|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626906|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626907|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626908|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626909|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626910|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626914|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626915|NCT02670473|O4|Outcome|Fanfilcon A: 4 Weeks|fanfilcon A lens (test)
626916|NCT02670473|O3|Outcome|Fanfilcon A: 2 Weeks|fanfilcon A lens (test)
626917|NCT02670473|O2|Outcome|Fanfilcon A: 1 Week|fanfilcon A lens (test)
626918|NCT02670473|O1|Outcome|Habitual Lenses: Baseline|enfilcon A habitual lens (control)
626919|NCT02670473|E1|Reported Event|Overall Participants|"Participants are habitual wearers of enfilcon A lens and refitted with fanfilcon A lens.~fanfilcon A (test): contact lens"
626920|NCT02669095|B3|Baseline|Total|Total of all reporting groups
626921|NCT02669095|B2|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
626922|NCT02669095|B1|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
626923|NCT02669095|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
626924|NCT02669095|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
626925|NCT02669095|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
626926|NCT02669095|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
626927|NCT02669095|O2|Outcome|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
626928|NCT02669095|O1|Outcome|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
626929|NCT02669095|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the entire duration of the study.
626930|NCT02669095|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the entire duration of the study.
626931|NCT02669043|B1|Baseline|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
626932|NCT02669043|P1|Participant Flow|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
626933|NCT02669043|O1|Outcome|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
626934|NCT02669043|E1|Reported Event|Ketamine|"All participants receive open-label ketamine~Ketamine: Intravenous ketamine 0.5mg/kg over 40 minutes"
626935|NCT02667704|B1|Baseline|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
626936|NCT02667704|P1|Participant Flow|Nintedanib (Reference (R)) / Bosentan+Nintedanib (Test (T))|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 and then multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 of period 2 administered orally with 240 millilitre (mL) of water
626937|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
626938|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
626939|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
626940|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
626941|NCT02667704|O2|Outcome|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 8 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
626942|NCT02667704|O1|Outcome|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 administered orally with 240 millilitre (mL) of water.
626943|NCT02667704|E3|Reported Event|Bosentan+Nintedanib (T)|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 7 and 8 of period 2 plus single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 7 administered orally with 240 mL of water
626944|NCT02667704|E2|Reported Event|Bosentan|Subject received multiple doses of 250 mg Bosentan (2 x 1 film-coated tablets) on days 1 to 6 of period 2 administered orally with 240 mL of water
626945|NCT02667704|E1|Reported Event|Nintedanib (R)|Subject received single dose of 150 milligram (mg) Nintedanib (1 x 1 soft gelatin capsule) on day 1 of period 1 administered orally with 240 millilitre (mL) of water.
626946|NCT02666560|B1|Baseline|All Study Participants|"Participants performed a functional task with auditory cueing set at self paced cadence and 20% above self paced cadence.~Auditory Cueing: This was delivered by a metronome producing a beat which was set at the participant's baseline cadence or 20% above baseline cadence.~This was a crossover design where participants completed both arms in the trial."
626947|NCT02666560|P2|Participant Flow|Cueing at 20% Above Self Paced Cadence Then Self Based Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence. Five days following participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: This was delivered by a metronome, which was set at a beat frequency rate 20% above baseline cadence or that matched the participant's baseline cadence."
627002|NCT02664532|B2|Baseline|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
626948|NCT02666560|P1|Participant Flow|Cueing Self Paced Then Cueing 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence. Five days following participants performed a functional task with auditory cueing set at 20% above self paced cadence.~Auditory Cueing: This was was delivered by a metronome, which was set at a beat frequency rate that matched the participant's baseline cadence or 20% above baseline cadence."
626949|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
626950|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
626951|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
626952|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
626953|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
626954|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
626955|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
626956|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
626957|NCT02666560|O2|Outcome|AC20|Auditory cueing at 20% above self paced cadence
626958|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
626959|NCT02666560|O2|Outcome|AC20|Auditory cueing set at 20% above self paced cadence
626960|NCT02666560|O1|Outcome|ACSC|Auditory cueing at self paced cadence
626961|NCT02666560|E2|Reported Event|Cueing at 20% Above Self Paced Cadence|"Participants performed a functional task with auditory cueing set at 20% above self paced cadence whilst performing a functional task.~Auditory Cueing: Auditory cueing set at different frequency rates"
626962|NCT02666560|E1|Reported Event|Auditory Cueing at Self Paced Cadence|"Participants performed a functional task with auditory cueing set at self paced cadence.~Auditory Cueing: Auditory cueing set at different frequency rates"
626963|NCT02666222|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626964|NCT02666222|P1|Participant Flow|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626965|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626966|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626967|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626968|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626969|NCT02666222|O1|Outcome|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626970|NCT02666222|E1|Reported Event|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
626971|NCT02665260|B5|Baseline|Total|Total of all reporting groups
626972|NCT02665260|B4|Baseline|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
626973|NCT02665260|B3|Baseline|Placebo|Patients treated with placebo without occlusion
626974|NCT02665260|B2|Baseline|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
626975|NCT02665260|B1|Baseline|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
626976|NCT02665260|P4|Participant Flow|Placebo Without Occlusion|Patients treated with placebo without conclusion
626977|NCT02665260|P3|Participant Flow|Placebo With Occlusion|Patients treated with placebo and occlusion
626978|NCT02665260|P2|Participant Flow|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
626979|NCT02665260|P1|Participant Flow|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
626980|NCT02665260|O4|Outcome|Placebo With Occlusion|Patients treated with placebo vehicle with occlusion
626981|NCT02665260|O3|Outcome|Placebo|Patients treated with placebo without occlusion
626982|NCT02665260|O2|Outcome|Cantharidin With Occlusion|Patients treated with 0.7% topical cantharidin with occlusion
626983|NCT02665260|O1|Outcome|Cantharidin|Patients treated with 0.7% topical cantharidin without occlusion
626984|NCT02665260|O4|Outcome|Placebo Without Occlusion|Patients treated with placebo without conclusion
626985|NCT02665260|O3|Outcome|Placebo With Occlusion|Patients treated with placebo and occlusion
626986|NCT02665260|O2|Outcome|Cantharidin Without Occlusion|Patients treated with cantharidin 0.7% topical without occlusion
626987|NCT02665260|O1|Outcome|Cantharidin With Occlusion|Patients treated with cantharidin 0.7% topical with occlusion
626988|NCT02665260|E4|Reported Event|Placebo With Occlusion|Subjects treated with placebo with occlusion
626989|NCT02665260|E3|Reported Event|Placebo|Subjects treated with placebo without occlusion
626990|NCT02665260|E2|Reported Event|Cantharidin With Occlusion|Subjects treated with topical cantharidin 0.7% with occlusion
626991|NCT02665260|E1|Reported Event|Cantharidin|Subjects treated with topical cantharidin 0.7% without occlusion
626992|NCT02664987|B1|Baseline|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
626993|NCT02664987|P1|Participant Flow|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
626994|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
626995|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
626996|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
626997|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
626998|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
626999|NCT02664987|O1|Outcome|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
627000|NCT02664987|E1|Reported Event|Patients Receiving Cancer Pain Treatment|Single arm -- Patients receiving cancer pain treatment
627001|NCT02664532|B3|Baseline|Total|Total of all reporting groups
627022|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
627003|NCT02664532|B1|Baseline|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
627004|NCT02664532|P2|Participant Flow|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
627005|NCT02664532|P1|Participant Flow|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
627006|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
627007|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
627008|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
627009|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
627010|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
627011|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
627012|NCT02664532|O2|Outcome|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
627013|NCT02664532|O1|Outcome|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
627014|NCT02664532|E2|Reported Event|Macintosh Group|"In Macintosh group, the curved blade was introduced to lift the base of the epiglottis to visualize larynx and then trachea intubated conventionally.After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Macintosh group: Macintosh blade was used for laryngoscopy"
627015|NCT02664532|E1|Reported Event|Miller Group|"In Miller group, no 3 Miller blade was used for laryngoscopy by paraglossal technique. While intubating, the endotracheal tube (ETT) was directed underneath the laryngoscope blade without allowing it to go lateral to the blade. The curvature of the ETT automatically brings the tip towards the vocal cords as it was advanced. After successful endotracheal intubation, the ETT was attached to the circuit and anaesthesia continued as per plan.~Miller group: Miller blade was used for laryngoscopy"
627016|NCT02664311|B3|Baseline|Total|Total of all reporting groups
627017|NCT02664311|B2|Baseline|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
627018|NCT02664311|B1|Baseline|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
627019|NCT02664311|P2|Participant Flow|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
627020|NCT02664311|P1|Participant Flow|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
627021|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
627134|NCT02656485|B4|Baseline|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627023|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
627024|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
627025|NCT02664311|O2|Outcome|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
627026|NCT02664311|O1|Outcome|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
627027|NCT02664311|E2|Reported Event|Jet Ventilation|"Patients receiving Jet ventilation while under general anesthesia and during mapping and ablation in the left atrium~Jet Ventilation: Patients are randomized to receive either jet or conventional ventilation during this study"
627028|NCT02664311|E1|Reported Event|Conventional Ventilation|"Patients receiving conventional ventilation for the duration of this study~Conventional ventilation: Conventional ventilator - control arm"
627029|NCT02663453|B3|Baseline|Total|Total of all reporting groups
627030|NCT02663453|B2|Baseline|Control Group|"pure soybean oil lipid emulsion(intralipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~pure soybean oil lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
627031|NCT02663453|B1|Baseline|Study Group|"multicomponent lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~multicomponent lipid emulsion: Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached."
627032|NCT02663453|P2|Participant Flow|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627033|NCT02663453|P1|Participant Flow|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627034|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627035|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627036|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627037|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627067|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627135|NCT02656485|B3|Baseline|Dose III|"B244 dose strength III~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
629840|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
627038|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627039|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627040|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627041|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627042|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627043|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627044|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627045|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627046|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627047|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627048|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627049|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627050|NCT02663453|O2|Outcome|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627051|NCT02663453|O1|Outcome|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627052|NCT02663453|E2|Reported Event|Control Group|"pure soybean oil lipid emulsion was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5gm/kg/day was reached.The macronutrients and micronutrients were provided using the same products in both groups.~Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day"
627053|NCT02663453|E1|Reported Event|Study Group|multi component lipid emulsion composed of 30% soybean oil, 30% MCTs, 25% olive oil and 15% fish oil (SMOF lipid) was administered at a dose of 1 gm/kg/day within 24 hours after birth; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.The macro nutrients and micro nutrients were provided using the same products in both groups. Parenteral lipid was temporarily stopped when plasma triglyceride (TG) concentrations exceeded 250 mg/dL. Minimal enteral feeding was initiated on the day of birth and intake was advanced with 20 ml/ kg/day of breast milk or preterm formula. Parenteral nutrition was stopped when the oral feeding reached 120 ml/kg/day
627054|NCT02663232|B1|Baseline|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627055|NCT02663232|P1|Participant Flow|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627056|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627057|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627058|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627059|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627060|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627061|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627062|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627063|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627064|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627065|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627066|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627289|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
627068|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627069|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627070|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627071|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627072|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627073|NCT02663232|O1|Outcome|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627074|NCT02663232|E1|Reported Event|Metastatic Melanoma|Participants with metastatic melanoma who attended their physicians during the 18-month recruitment period and had valid biological samples available for BRAF mutation testing were included in the study. There was no intervention in this study.
627075|NCT02662608|B1|Baseline|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
627076|NCT02662608|P1|Participant Flow|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
627077|NCT02662608|O1|Outcome|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
627078|NCT02662608|E1|Reported Event|Brontictuzumab|Brontictuzumab 1.5 mg/Kg intravenously every 3 weeks.
627079|NCT02662556|B1|Baseline|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
627080|NCT02662556|P1|Participant Flow|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
627081|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
627082|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
627083|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
627084|NCT02662556|O1|Outcome|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: one sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
627085|NCT02662556|E1|Reported Event|Sufentanil Sublingual Tablet (SST) 30 mcg|"Sufentanil sublingual tablet (SST) 30 mcg~Sufentanil sublingual tablet (SST) 30 mcg: sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours."
627086|NCT02658461|B4|Baseline|Total|Total of all reporting groups
627087|NCT02658461|B3|Baseline|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627088|NCT02658461|B2|Baseline|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627089|NCT02658461|B1|Baseline|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627090|NCT02658461|P3|Participant Flow|Trastuzumab Intravenous (IV) Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed greater than (>) 1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627091|NCT02658461|P2|Participant Flow|Trastuzumab Subcutaneous (SC) Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627092|NCT02658461|P1|Participant Flow|Trastuzumab Single-Use Injection Device|Participants with human epidermal growth factor receptor 2 (HER2)-positive early breast cancer (EBC) received trastuzumab via single-use injection device as 600 milligrams (mg) on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627113|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
629841|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
627093|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627094|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627095|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627096|NCT02658461|O3|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627097|NCT02658461|O2|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627098|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627099|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627100|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627101|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627102|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627103|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627104|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627105|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627106|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627107|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627108|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627109|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627110|NCT02658461|O1|Outcome|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627111|NCT02658461|O1|Outcome|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627112|NCT02658461|O1|Outcome|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627114|NCT02658461|E3|Reported Event|Trastuzumab IV Infusion|Participants with HER2-positive EBC received trastuzumab via IV infusion as 6 mg/kg on Day 1 of each 3-week cycle for a total of 18 cycles. An initial loading dose of 8 mg/kg was given during the first cycle, and also reserved as a reloading dose if treatment was delayed >1 week. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627115|NCT02658461|E2|Reported Event|Trastuzumab SC Injection|Participants with HER2-positive EBC received trastuzumab via SC injection using vial/syringe as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627116|NCT02658461|E1|Reported Event|Trastuzumab Single-Use Injection Device|Participants with HER2-positive EBC received trastuzumab via single-use injection device as 600 mg on Day 1 of each 3-week cycle for a total of 18 cycles. Trastuzumab was supplied in the MO22982 (NCT01401166) trial and dosed according to local labeling.
627117|NCT02657629|B3|Baseline|Total|Total of all reporting groups
627118|NCT02657629|B2|Baseline|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627119|NCT02657629|B1|Baseline|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627120|NCT02657629|P2|Participant Flow|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627121|NCT02657629|P1|Participant Flow|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627122|NCT02657629|O2|Outcome|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627123|NCT02657629|O1|Outcome|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627124|NCT02657629|E2|Reported Event|Intermittent Bolus Feeding Regimen|"Enteral feedings given as intermittent bolus feedings for entire 24 hour period.~Intermittent Bolus Feeding Regimen: Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627125|NCT02657629|E1|Reported Event|Continuous Feeding Regimen|"Enteral feedings given as combination of continuous nocturnal feedings and intermittent bolus daytime feedings.~Continuous Feeding Regimen: Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d."
627126|NCT02657538|B1|Baseline|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
627127|NCT02657538|P1|Participant Flow|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
627128|NCT02657538|O1|Outcome|All Study Participants|"35 participants with either initial caries and/or no carious lesion were included in this study.~The participants had to be at least 14 years old, in good health (ASA-Status 1) and they had to give their informed consent."
627129|NCT02657538|O2|Outcome|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
627130|NCT02657538|O1|Outcome|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
627131|NCT02657538|E2|Reported Event|Visual Caries Detection + BW|"visual caries detection + bite wing radiography (BW): considered as gold standard in caries diagnostics.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Visual examination and bitewing (BW) radiography: established diagnostic methods"
627132|NCT02657538|E1|Reported Event|Near Infrared Transillumination|"Near infrared transillumination is applied for initial enamel caries lesion detection.~Non invasive caries treatment: If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.~Invasive caries treatment: If the active comparator does detect cavitation, a composite restauration is placed~Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)"
627136|NCT02656485|B2|Baseline|Dose II|"B244 dose strength II~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627137|NCT02656485|B1|Baseline|Dose I|"B244 dose strength I~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627138|NCT02656485|P4|Participant Flow|Placebo|Placebo: 10 pumps of spray applied BID twice a day to the entire face for 14 days
627139|NCT02656485|P3|Participant Flow|Dose III|BB244 Dose III: 10 pumps of spray applied BID twice a day to the entire face for 14 days
627140|NCT02656485|P2|Participant Flow|Dose II|BB244 Dose II : 10 pumps of spray applied BID twice a day to the entire face for 14 days
627141|NCT02656485|P1|Participant Flow|Dose I|BB244 Dose I : 10 pumps of spray applied BID twice a day to the entire face for 14 days
627142|NCT02656485|O2|Outcome|Placebo|Placebo Arm
627143|NCT02656485|O1|Outcome|Pooled Active Doses|Pooled Active Doses (Doses I, II, III)
627144|NCT02656485|O4|Outcome|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627145|NCT02656485|O3|Outcome|Dose III|"B244 dose III~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627146|NCT02656485|O2|Outcome|Dose II|"B244 dose II~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627147|NCT02656485|O1|Outcome|Dose I|"B244 dose I~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627148|NCT02656485|E4|Reported Event|Placebo|"Placebo~Placebo: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627149|NCT02656485|E3|Reported Event|Dose III|"B244 Dose 3 (dose level [cells/mL] 80,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627150|NCT02656485|E2|Reported Event|Dose II|"B244 Dose 2 (dose level [cells/mL] 40,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627151|NCT02656485|E1|Reported Event|Dose I|"B244 Dose 1 (dose level [cells/mL] 20,000,000,000)~B244: 10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days"
627152|NCT02656160|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis.
627153|NCT02656160|P2|Participant Flow|Placebo First, 4-AP Second|Placebo-matching 4-AP administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then 4-AP administered 3 hours before normal sleep time on second study night.
627154|NCT02656160|P1|Participant Flow|4-AP First, Placebo Second|4-AP 10 mg administered 3 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching 4-AP administered 3 hours before normal sleep time on second study night.
627155|NCT02656160|O2|Outcome|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
627156|NCT02656160|O1|Outcome|Placebo|Placebo: Placebo 3 hrs before sleep
627157|NCT02656160|O2|Outcome|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
627158|NCT02656160|O1|Outcome|Placebo|Placebo: Placebo 3 hrs before sleep
627159|NCT02656160|E2|Reported Event|Dalfampridine|Dalfampridine: Dalfampridine 10 mg extended release 3 hrs before sleep
627160|NCT02656160|E1|Reported Event|Placebo|Placebo: Placebo 3 hrs before sleep
627161|NCT02653560|B1|Baseline|All Study Participants|Participants took Potassium magnesium Citrate (KMgCit), potassium citrate (KCit), potassium chloride (KCl) and placebo each for 4 weeks in a randomized crossover design.
627162|NCT02653560|P4|Participant Flow|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
627163|NCT02653560|P3|Participant Flow|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
627164|NCT02653560|P2|Participant Flow|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
627165|NCT02653560|P1|Participant Flow|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
627166|NCT02653560|O4|Outcome|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
627167|NCT02653560|O3|Outcome|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
627168|NCT02653560|O2|Outcome|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
627169|NCT02653560|O1|Outcome|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
627290|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
627291|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
627170|NCT02653560|E4|Reported Event|Placebo|"Placebo will comprise microcrystalline cellulose, equivalent in volume in each sachet as other test products. During the Placebo Phase, subjects will dissolve the entire content of a sachet in 250 ml water and drink it with breakfast and again with dinner for 4 weeks.~Placebo"
627171|NCT02653560|E3|Reported Event|Potassium Chloride Arm|"Potassium chloride will contain 20 meq KCl per sachet. During the Potassium Chloride Phase, subjects will dissolve the content of each sachet in 250 ml water and ingest it with breakfast and again with dinner, to deliver 40 meq K (as chloride) per day for 4 weeks~Potassium chloride powder"
627172|NCT02653560|E2|Reported Event|Potassium Citrate Arm|"A special sachet formulation containing 20 meq K/sachet will be made for the study by Meta Pharm Development. The contents of a sachet will be added to 250 ml water and drunk with breakfast and dinner, to deliver 40 meq K (as citrate) per day during the Potassium Citrate Phase for 4 weeks.~Potassium citrate powder"
627173|NCT02653560|E1|Reported Event|Potassium Magnesium Citrate (KMgCit) Arm|"Potassium magnesium citrate will be prepared by mixing potassium citrate, magnesium citrate and/or citric acid by Meta Pharm Development. The content of each sachet will be dissolved in 250 ml water and will be drunk with breakfast and again with dinner during the KMgCit Phase, to deliver 40 meq K, 20 meq Mg and 74 meq citrate per day for 4 weeks~Potassium magnesium Citrate (KMgCit)"
627174|NCT02651467|B4|Baseline|Total|Total of all reporting groups
627175|NCT02651467|B3|Baseline|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627176|NCT02651467|B2|Baseline|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627177|NCT02651467|B1|Baseline|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627178|NCT02651467|P3|Participant Flow|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627179|NCT02651467|P2|Participant Flow|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627180|NCT02651467|P1|Participant Flow|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% weight by weight [w/w] KOX, 0 parts per million [ppm], pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627181|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627182|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627183|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627292|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
627293|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
627294|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
627295|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
629842|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
627184|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )(using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627185|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627186|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627187|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627188|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627189|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627190|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627191|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627192|NCT02651467|O3|Outcome|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 ) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627193|NCT02651467|O2|Outcome|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (Oral rinse 2.0% w/w KOX, 45ppm F, pH 4.5) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627194|NCT02651467|O1|Outcome|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (Oral rinse 1.5% w/w KOX, 0ppm F, pH 7.0) (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627195|NCT02651467|E3|Reported Event|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Placebo oral rinse (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627296|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
627297|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
627298|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
627299|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
627196|NCT02651467|E2|Reported Event|Treatment 2 (Oral Rinse 2.0% w/w KOX, 45ppm F, pH 4.5)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20mL of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 2 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627197|NCT02651467|E1|Reported Event|Treatment 1 (Oral Rinse 1.5% w/w KOX, 0ppm F, pH 7.0)|Participants applied a strip of standard fluoride toothpaste to cover the full head of the toothbrush and brushed their teeth for one timed minute and expectorated. After that, they rinsed with 20millilitre (mL) of tap water (using the dosing cap provided) for 10 seconds and expectorated, then again rinsed with 10mL of Treatment 1 (using the second dosing cap provided) for one timed minute and expectorated. No further rinsing was allowed. This regimen was performed twice daily for 8 weeks.
627198|NCT02650219|B3|Baseline|Total|Total of all reporting groups
627199|NCT02650219|B2|Baseline|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
627200|NCT02650219|B1|Baseline|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
627201|NCT02650219|P2|Participant Flow|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
627202|NCT02650219|P1|Participant Flow|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
627203|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
627204|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
627205|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
627206|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
627207|NCT02650219|O2|Outcome|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
627208|NCT02650219|O1|Outcome|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
627209|NCT02650219|E2|Reported Event|Control|"healthy subjects intervention: genetic analyses~genetic analyses"
627210|NCT02650219|E1|Reported Event|Gaucher Disease Type 1|"Inclusion criteria:~Adult patients >= 18 years old~Gaucher disease type 1, proved by low betaglucosidase, with or without treatment~Patients must have read, understood and signed informed consent. intervention : genetic analyses~genetic analyses"
627211|NCT02649634|B3|Baseline|Total|Total of all reporting groups
627212|NCT02649634|B2|Baseline|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627213|NCT02649634|B1|Baseline|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627214|NCT02649634|P2|Participant Flow|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627215|NCT02649634|P1|Participant Flow|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627300|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
627216|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627217|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627218|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627219|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627220|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627221|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627222|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627223|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627301|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
627302|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
627303|NCT02648438|O2|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
627304|NCT02648438|O1|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
627305|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
627224|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627225|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627226|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627227|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627228|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627229|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627230|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627231|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627306|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
627307|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
627308|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
627309|NCT02648438|E6|Reported Event|pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (separate treatment)
627310|NCT02648438|E5|Reported Event|Oral Formulation|AZD7594 1200 μg oral formulation
627232|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627233|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627234|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627235|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627236|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627237|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627238|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627239|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627311|NCT02648438|E4|Reported Event|pMDI|AZD7594 400 μg delivered dose pMDI
627312|NCT02648438|E3|Reported Event|DPI Device 2|AZD7594 400 μg delivered dose multiple-dose DPI
627313|NCT02648438|E2|Reported Event|DPI Device 1|AZD7594 400 μg delivered dose monodose inhaler
627314|NCT02648438|E1|Reported Event|IV Formulation|AZD7594 150 μg IV formulation
627315|NCT02648022|B3|Baseline|Total|Total of all reporting groups
629843|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
627240|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627241|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627242|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627243|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627244|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627245|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627246|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627247|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627316|NCT02648022|B2|Baseline|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
627433|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
629844|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
627248|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627249|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627250|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627251|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627252|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627253|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627254|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627255|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627330|NCT02646449|B1|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
627434|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627256|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627257|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627258|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627259|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627260|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627261|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627262|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627263|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627331|NCT02646449|P2|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
628066|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
627264|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627265|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627266|NCT02649634|O2|Outcome|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627267|NCT02649634|O1|Outcome|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627268|NCT02649634|E2|Reported Event|Attention Control|"Two 45-60 minute semi-structured interviews ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits, acting as a pseudo-intervention.~Attention Control: The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues)."
627269|NCT02649634|E1|Reported Event|Motivational Interviewing|"Two 45-60 minute motivational interviewing sessions focusing on ambivalence towards change.~Motivational Interviewing: The semi-structured MI protocol was a 45-minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components."
627270|NCT02648438|B4|Baseline|Total|Total of all reporting groups
627271|NCT02648438|B3|Baseline|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
627272|NCT02648438|B2|Baseline|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
627273|NCT02648438|B1|Baseline|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
627274|NCT02648438|P3|Participant Flow|pMDI (Additional)|Pressurized metered-dose inhaler (pMDI)
627275|NCT02648438|P2|Participant Flow|IV, DPI 1, pMDI, Oral|IV formulation, monodose inhaler, pMDI, oral formulation
627276|NCT02648438|P1|Participant Flow|IV, DPI 1, DPI 2, Oral|IV formulation, monodose inhaler, multiple-dose DPI, oral formulation
627277|NCT02648438|O6|Outcome|1200 µg Oral Formulation|AZD7594 1200 μg oral formulation
627278|NCT02648438|O5|Outcome|150 µg IV Formulation|AZD7594 150 µg IV formulation
627279|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
627280|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
627281|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
627282|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
627283|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
627284|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
627285|NCT02648438|O2|Outcome|400 µg DPI Device 2|AZD7594 400 μg delivered dose via Multiple dose inhaler
627286|NCT02648438|O1|Outcome|400 µg DPI Device 1|AZD7594 400 μg delivered dose via Monodose inhaler
627287|NCT02648438|O4|Outcome|400 µg pMDI (Additional)|AZD7594 400 μg delivered dose pMDI (Separate treatment)
627288|NCT02648438|O3|Outcome|400 µg pMDI|AZD7594 400 μg delivered dose pMDI
627317|NCT02648022|B1|Baseline|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
627318|NCT02648022|P2|Participant Flow|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
627319|NCT02648022|P1|Participant Flow|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
627320|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
627321|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
627322|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
627323|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
627324|NCT02648022|O2|Outcome|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
627325|NCT02648022|O1|Outcome|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
627326|NCT02648022|E2|Reported Event|Usual Care|"The usual care group received standard of care required for HCV patients as currently performed in each clinic. All usual care patients were evaluated by their HCV Clinic treatment team, usually consisting of clinical nursing staff, the treating physician, and a clinic psychiatrist or psychologist"
627327|NCT02648022|E1|Reported Event|Integrated Care|"Consisted of brief mental health interventions and case management provided in a collaborative treatment environment.~Brief mental health interventions and case management: The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians."
627328|NCT02646449|B3|Baseline|Total|Total of all reporting groups
627329|NCT02646449|B2|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
627435|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
629845|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
627332|NCT02646449|P1|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
627333|NCT02646449|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
627334|NCT02646449|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
627335|NCT02646449|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
627336|NCT02646449|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
627337|NCT02646449|E2|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
627338|NCT02646449|E1|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2."
627339|NCT02645760|B3|Baseline|Total|Total of all reporting groups
627340|NCT02645760|B2|Baseline|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
627341|NCT02645760|B1|Baseline|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
627342|NCT02645760|P2|Participant Flow|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
627343|NCT02645760|P1|Participant Flow|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
627344|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
627345|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
627346|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
627363|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
628067|NCT02621034|E3|Reported Event|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
627347|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) in
627348|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
627349|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
627350|NCT02645760|O2|Outcome|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
627351|NCT02645760|O1|Outcome|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
627352|NCT02645760|E2|Reported Event|Conventional Treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack Participants were received 5 minutes of therapeutic ultrasound which used a 1-MHz ultrasound frequency with the intensity of 0.8-1.0 W/cm2 by continuous mode. The sound head moved in small circles or longitudinal strokes around the painful area of lower back in a side lying position. The participant was received 15 minutes of the hydrocollator pack therapy (60 °C) which placed under the painful area of lower back in a supine lying position after receive therapeutic ultrasound.
627353|NCT02645760|E1|Reported Event|Core Stabilization Exercise|7-weeks of core stabilization exercise Participants were received treatment with Core stabilization exercise (CSE) which applied from the treatment approaches of Puntumetakul et al (2013). 20-minute sessions, 2 sessions per week all over 7 weeks by a physical therapist (researcher number 2) and home exercises every day with recording this practice (duration and frequency of exercise) in the diary over the study period. This exercise aims for training the activation of the local muscle system (the deep muscle layer) including the transversus abdominis (TrA) and lumbar multifidus (LM) muscles.
627354|NCT02645123|B4|Baseline|Total|Total of all reporting groups
627355|NCT02645123|B3|Baseline|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627356|NCT02645123|B2|Baseline|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627357|NCT02645123|B1|Baseline|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627358|NCT02645123|P3|Participant Flow|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)~Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692~swedish type massage: petrissage, effleurage, tapotement~muscle stretching: static hamstring stretching"
627359|NCT02645123|P2|Participant Flow|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes~sham treatment: touching of the skin overlying the lumbar area"
627360|NCT02645123|P1|Participant Flow|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration~spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
627361|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627362|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627386|NCT02644109|B3|Baseline|Total|Total of all reporting groups
628068|NCT02621034|E2|Reported Event|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
627364|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627365|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627366|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627367|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627368|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627369|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627370|NCT02645123|O3|Outcome|Classic Physiotherapy|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627371|NCT02645123|O2|Outcome|Sham Treatment|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627372|NCT02645123|O1|Outcome|Spinal Mobilization|The individuals of the group were asked to fill-in the Roland-Morris and the Oswestry questionnaires. The researcher assessed the baseline pain using the numerical pain rating scale. In addition, the gait of all subjects was assessed using 3D kinematic analysis and force platforms to assess kinetic values.
627373|NCT02645123|E3|Reported Event|Classic Physiotherapy|"This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)~Transcutaneous electrical nerve stimulation: Enraf-Nonius Sonopuls 692~swedish type massage: petrissage, effleurage, tapotement~muscle stretching: static hamstring stretching"
627374|NCT02645123|E2|Reported Event|Sham Treatment|"The investigator touched the skin overlying the low back statically for 10 minutes~sham treatment: touching of the skin overlying the lumbar area"
627375|NCT02645123|E1|Reported Event|Spinal Mobilization|"The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration~spinal mobilization: passive physiological intervertebral movements and passive accessory posteroanterior mobilization"
627376|NCT02644356|B1|Baseline|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627377|NCT02644356|P1|Participant Flow|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627378|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627379|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627380|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627381|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627382|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627383|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627384|NCT02644356|O1|Outcome|Online CE/CME Course|"Participant in taking the three course modules and completing pre- and post-course data collection.~Online CE/CME course: Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions"
627385|NCT02644356|E1|Reported Event|Online CE/CME Course|All subjects were assigned to take the three course modules of an online CE/CME course and complete pre- and post-course data collection. Module topics consisted of acupuncture, massage, and music-related interventions
627387|NCT02644109|B2|Baseline|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
627388|NCT02644109|B1|Baseline|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
627389|NCT02644109|P2|Participant Flow|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols.~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
627390|NCT02644109|P1|Participant Flow|Phytosterols|"Milk powder: subjects will consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols).~Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire), presence of symptoms and side effects will be determined. Then will be randomly assigned to one of the groups.~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
627391|NCT02644109|O2|Outcome|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
627392|NCT02644109|O1|Outcome|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
627393|NCT02644109|E2|Reported Event|Placebo|"Milk powder: subjects will be instructed to consume 22 g/day of the product, without phytosterols. The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day without phytosterols. Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
627394|NCT02644109|E1|Reported Event|Phytosterols|"Milk powder: subjects will be instructed to consume 22 g/day of the product, with 0.65 g of esterified phytosterols (0.39 g of free equivalent sterols). The product will be reconstituted with 200 ml of water at time of consumption, preferably at breakfast or tea time. The total amount of product will be provided at the beginning of the study (day 1), together with instructions, material for preparation, and storage.~Drinking yoghurt: the daily volume consumed will be 90 ml/day with 1.3 grs of esterified phytosterols (0.78 g of free equivalent phytosterols). Subjects will be instructed to consume this beverage with main meal (not later than 15 min after it. The product should be kept refrigerated. Products will be distributed to subjects on a weekly basis."
627395|NCT02644096|B3|Baseline|Total|Total of all reporting groups
627396|NCT02644096|B2|Baseline|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
627397|NCT02644096|B1|Baseline|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
627398|NCT02644096|P2|Participant Flow|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR"
627399|NCT02644096|P1|Participant Flow|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
627400|NCT02644096|O2|Outcome|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation.after THR."
627401|NCT02644096|O1|Outcome|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
627402|NCT02644096|E2|Reported Event|Intervention|"counselling and support after discharge from hospital~counselling and support after discharge from hospital: patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR."
627403|NCT02644096|E1|Reported Event|Conventional Treatment|After surgery, patients with total hip replacement are only seen once 3 months after surgery, and they have no further contact with the hospital.
627404|NCT02643225|B3|Baseline|Total|Total of all reporting groups
627405|NCT02643225|B2|Baseline|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627406|NCT02643225|B1|Baseline|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627407|NCT02643225|P2|Participant Flow|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
627408|NCT02643225|P1|Participant Flow|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed twice at 27-28 weeks and 36-37 weeks of gestation prospectively.~During ultrasound, fetal biometry (biparietal diameter, abdominal circumference, femur length) and estimated fetal weight will be calculated automatically according to hadlock’s formula additionally, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device.~The cross sectional area of Wharton’s jelly will be computed by subtracting the cross sectional area of the vessels from that of the umbilical cord and the interventricular septum thickness will be measured.~HbA1c levels will be measured for diabetes patients."
627409|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627410|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627411|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627412|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627431|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627432|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627413|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627414|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627415|NCT02643225|O2|Outcome|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627416|NCT02643225|O1|Outcome|Pregnant Women With Gestational Diabetes|"case group The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627417|NCT02643225|E2|Reported Event|Non Diabetic Pregnant Women|"control group~The investigation will be performed to non diabetic pregnant women:~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627418|NCT02643225|E1|Reported Event|Pregnant Women With Gestational Diabetes|"case group~The investigation will be performed to pregnant women with gestational diabetes~Calculation of gestational age will be based on the last reliable menstrual period or the first trimester ultrasound.~Ultrasound examination will be performed at 36-37 weeks of gestation prospectively.~During ultrasound, the sonographic cross sectional area of umbilical cord, the umbilical arteries and umbilical vein will be measured in a free loop of the umbilical cord using the software of the ultrasound device and the interventricular septum thickness will be measured.~HbA1c levels will be measured for participants."
627419|NCT02643199|B1|Baseline|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
627420|NCT02643199|P1|Participant Flow|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
627421|NCT02643199|O1|Outcome|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
627422|NCT02643199|O1|Outcome|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
627423|NCT02643199|E1|Reported Event|Pregnant Women From 20 to 36 Weeks of Pregnancy|"This is a Prospective pilot study that was performed at the Fetal Care Unit at Ain Shams University Maternity Hospital.~90 pregnant women were recruited from the Fetal Care Unit who will fulfill the inclusion criteria.~Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal Heart."
627424|NCT02643004|B1|Baseline|Overall Baseline Characteristics|"Participants were randomized to wear senofilcon A or stenfilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens~Stenfilcon A: contact lens"
627425|NCT02643004|P2|Participant Flow|Stenfilcon A, Then Senofilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens~Senofilcon A: contact lens"
627426|NCT02643004|P1|Participant Flow|Senofilcon A, Then Stenfilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens~Stenfilcon A: contact lens"
627427|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627428|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627429|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627430|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627436|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627437|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627438|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627439|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627440|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627441|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627442|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627443|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627444|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627445|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627446|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627447|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627448|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627449|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627450|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627451|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627452|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627453|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627454|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627455|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627456|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627457|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627458|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627459|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627460|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627461|NCT02643004|O2|Outcome|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627462|NCT02643004|O1|Outcome|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627463|NCT02643004|E2|Reported Event|Stenfilcon A|"Participants were randomized to wear stenfilcon A lens pair for one week during the crossover study.~Stenfilcon A: contact lens"
627464|NCT02643004|E1|Reported Event|Senofilcon A|"Participants were randomized to wear senofilcon A lens pair for one week during the crossover study.~Senofilcon A: contact lens"
627465|NCT02642575|B1|Baseline|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
627466|NCT02642575|P1|Participant Flow|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
627467|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
627468|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
627492|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
629846|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
627469|NCT02642575|O1|Outcome|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
627470|NCT02642575|E1|Reported Event|Folliculometry in Women With Unexplained Infertility|67 women who were recruited from the Fetal Care Unit who fulfilled the inclusion criteria, would be receiving ovarian stimulation using clomiphene citrate (clomid 50 mg) for ≥5 days starting from 5th day of the cycle then they will be scanned by the same physician using Two Dimensional Ultrasound then Five Dimensional Ultrasound.
627471|NCT02641912|B3|Baseline|Total|Total of all reporting groups
627472|NCT02641912|B2|Baseline|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627473|NCT02641912|B1|Baseline|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627474|NCT02641912|P2|Participant Flow|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627475|NCT02641912|P1|Participant Flow|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 milliliter (mL) of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627476|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
627477|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
627478|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
627479|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
627480|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
627481|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
627482|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627483|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627484|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627485|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627486|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627487|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627488|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627489|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627490|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627491|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627493|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627494|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627495|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627496|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
627497|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
627498|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627499|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627500|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627501|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627502|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627503|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627504|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
627505|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
627506|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
627507|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
627508|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
627509|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
627510|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
627511|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
627512|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drunken water as often as required. Participants consumed their own water for home use.
627513|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were used per day.
627514|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627515|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
628069|NCT02621034|E1|Reported Event|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
628070|NCT02619812|B5|Baseline|Total|Total of all reporting groups
627516|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627517|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627518|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
627519|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
627520|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627521|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627522|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627523|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627524|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627525|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627526|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627527|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627528|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627529|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627530|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627531|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627532|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627533|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627534|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627535|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627536|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627537|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627538|NCT02641912|O2|Outcome|Mineral Water|During supervised product use: Participants took a dose (drink) of one measured sip of 15mL of water. At Home: Participants drank water as often as required. Participants consumed their own water for home use.
627837|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627539|NCT02641912|O1|Outcome|Experimental Mouthwash|During supervised product use: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. No rinsing with water immediately after product usage was permitted. At Home: Participants rinsed with 15 mL of mouthwash for 30 seconds and spat out. A maximum of two doses were used per day.
627540|NCT02641912|E2|Reported Event|Mineral Water|During supervised product use: Participants were instructed to take a dose (drink) of one measured sip of 15mL of water. At Home: Participants were instructed to drink water as often as required. Participants consumed their own water for home use.
627541|NCT02641912|E1|Reported Event|Experimental Mouthwash|During supervised product use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. Immediate rinsing with water after product usage was not permitted. At Home use: Participants were instructed to rinse their mouth with 15 mL of mouthwash for 30 seconds and spit out. A maximum of two doses were allowed to use per day.
627542|NCT02641379|B12|Baseline|Total|Total of all reporting groups
627543|NCT02641379|B11|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627544|NCT02641379|B10|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
627545|NCT02641379|B9|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627546|NCT02641379|B8|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627547|NCT02641379|B7|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627548|NCT02641379|B6|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627549|NCT02641379|B5|Baseline|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627550|NCT02641379|B4|Baseline|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627551|NCT02641379|B3|Baseline|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
627552|NCT02641379|B2|Baseline|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
629847|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
627553|NCT02641379|B1|Baseline|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627554|NCT02641379|P11|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627555|NCT02641379|P10|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (≤ 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
627556|NCT02641379|P9|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627557|NCT02641379|P8|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627558|NCT02641379|P7|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627559|NCT02641379|P6|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (≥ 15 IU/ml, TaqMan® HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627560|NCT02641379|P5|Participant Flow|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627561|NCT02641379|P4|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a rapid virological response (RVR) at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627562|NCT02641379|P3|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (≥ 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
627563|NCT02641379|P2|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627693|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
628599|NCT02604264|P2|Participant Flow|Control|Standard hemodialysis end cap
627564|NCT02641379|P1|Participant Flow|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received pegylated interferon alpha-2a (PEG-IFN alfa-2a) at a dose of 180 microgram (mcg) subcutaneously (SC) once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 milligram/day (mg/day) [for participants with a body weight </= 75 kilogram (kg)] or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an early virological response (EVR) defined as non-detectable serum hepatitis C virus ribonucleic acid (HCV RNA) [< 600 international units/milliliter (IU/ml)] by quantitative polymerase chain reaction (PCR) or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627565|NCT02641379|O6|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627566|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
627567|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627568|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627569|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627570|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627571|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
627572|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627573|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627574|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627694|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627695|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627575|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627576|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627577|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627578|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627579|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627580|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627581|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627582|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627583|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627584|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627585|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627838|NCT02632812|E2|Reported Event|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
629137|NCT02576639|O4|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
627586|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627587|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627588|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627589|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627590|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627591|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627592|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
627593|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627594|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627595|NCT02641379|O5|Outcome|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627596|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627696|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
629138|NCT02576639|O3|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
627597|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
627598|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627599|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627600|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627601|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627602|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627603|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627604|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627605|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
627606|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627607|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627608|NCT02641379|O4|Outcome|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627609|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
627610|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627611|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627612|NCT02641379|O3|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight ≤ 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (≥ 15 IU/ml) and negative HCV RNA level at Week 8 (≤ 15 IU/ml) were assigned to group E. Participants had a treatment-free follow-up period of 24 weeks.
627613|NCT02641379|O2|Outcome|PEG-IFN Alfa 2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627614|NCT02641379|O1|Outcome|PEG-IFN Alfa 2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627615|NCT02641379|O2|Outcome|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627616|NCT02641379|O1|Outcome|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627617|NCT02641379|E11|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Assigned) (Part 2)|Eligible participants who were not assigned to any treatment group in Part 2 were included in this group. These participants were a part of the safety analysis population which included all participants who received at least on dose of (either) study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
628600|NCT02604264|P1|Participant Flow|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
627618|NCT02641379|E10|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group E) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dosage of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants with a positive HCV RNA level at Week 4 (>/= 15 IU/ml, TaqMan HCV Test) and negative HCV RNA level at Week 8 (</= 15 IU/ml, TaqMan HCV Test) were assigned to Group E. Participants had a treatment-free follow-up period of 24 weeks.
627619|NCT02641379|E9|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a negative HCV-RNA level at Week 4 (< 15 IU/ml, TaqMan HCV Test) were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627620|NCT02641379|E8|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without a > 2-log10 drop of HCV RNA level at Week 12 were assigned to Group C (Part 2). For participants who were HCV RNA-positive at Week 24, treatment was stopped. For participants who were negative for HCV RNA at Week 24, treatment was continued for a total of 72 weeks. Participants had a treatment-free follow-up period of 24 weeks.
627621|NCT02641379|E7|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 72 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. Participants were randomized to Group B1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627622|NCT02641379|E6|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A1) (Part 2)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A1 if they showed positive HCV RNA level (>/= 15 IU/ml, TaqMan HCV Test) at Week 4 and at Week 8, a negative HCV RNA level or > 2-log10 decline (TaqMan HCV test) at Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627623|NCT02641379|E5|Reported Event|PEG-IFN Alfa-2a + Ribavirin (Not Randomized) (Part 1)|Eligible participants who were not randomized to any treatment group in Part 1 of the study were included in this group. These participants were a part of the safety analysis population which included participants who received at least on dose of (either) the study drug (PEG-IFN alfa-2a and/or ribavirin) and had at least one post-baseline safety assessment.
627624|NCT02641379|E4|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24 Weeks (Group D) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 24 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 24 weeks. Participants with a RVR at Week 4 of treatment [HCV RNA level, <50 IU/ml by qualitative PCR assay, COBAS Amplicor HCV Test, version 2.0] were assigned to Group D. Participants had a treatment-free follow-up period of 24 weeks.
627625|NCT02641379|E3|Reported Event|PEG-IFN Alfa-2a + Ribavirin 24/72 Weeks (Group C) (Part 1)|Eligible participants were administered PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally; initially for 24 weeks. Participants without an EVR at Week 12 (< 2-log10 decrease in HCV RNA as compared with baseline) were assigned to Group C and received treatment until Week 24. If HCV RNA became non-detectable at Week 24 then treatment was continued for a total of 72 weeks. Participants were administered a lower dose of PEG-IFN alfa-2a after Week 48 (135 mcg/week, until Week 72). Participants with detectable HCV RNA (>= 50 IU/ml) at Week 24 were required to discontinue treatment. Participants had a treatment-free follow-up period of 24 weeks.
627626|NCT02641379|E2|Reported Event|PEG-IFN Alfa-2a + Ribavirin 72 Weeks (Group B) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for 48 weeks and also received ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 72 weeks. After Week 48, participants were administered a lower dose of PEG-IFN alfa-2a of 135 mcg/week until Week 72. Participants were randomized to Group B based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline in serum HCV RNA by quantitative PCR, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627627|NCT02641379|E1|Reported Event|PEG-IFN Alfa-2a + Ribavirin 48 Weeks (Group A) (Part 1)|Eligible participants received PEG-IFN alfa-2a at a dose of 180 mcg SC once weekly for a total of 48 weeks and ribavirin at a dose of 1,000 mg/day (for participants with a body weight </= 75 kg) or 1,200 mg/day (for participants with a body weight > 75 kg) orally for a total of 48 weeks. Participants were randomized to Group A based on the presence of an EVR defined as non-detectable serum HCV RNA (< 600 IU/ml) by quantitative PCR or a 2-log10 decrease or greater compared to baseline serum HCV RNA, shortly after Week 12. Participants had a treatment-free follow-up period of 24 weeks.
627628|NCT02641249|B1|Baseline|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627697|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
628601|NCT02604264|O2|Outcome|Control|Standard hemodialysis end cap
627629|NCT02641249|P1|Participant Flow|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627630|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627631|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627632|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627633|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627634|NCT02641249|O2|Outcome|Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627635|NCT02641249|O1|Outcome|No Vibration|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627636|NCT02641249|E1|Reported Event|All Subjects|"In the same subject cardiorespiratory parameters - heart rate, respiratory rate and oxygen saturation were compared during the procedure (vibration) and without procedure (no vibration). The same subject had both control and treatment periods.~Vibration: A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject."
627637|NCT02639052|B1|Baseline|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.~Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.~Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
627638|NCT02639052|P1|Participant Flow|Botox and Saline Vehicle Control|"10 units of both Botox and a saline vehicle will be intradermally injected into one forearm or the other on the first study visit. The subject will be blinded to which forearm receives the Botox and which forearm receives the saline vehicle.~Botox: 10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.~Saline: 10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit."
627639|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
627640|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
627641|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
627642|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
627643|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
627644|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
627645|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
627646|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
627647|NCT02639052|O2|Outcome|Saline|Saline vehicle intradermally injected into the other forearm
627648|NCT02639052|O1|Outcome|Botox|10 units of Botox intradermally injected into one forearm
627649|NCT02639052|E2|Reported Event|Saline|Saline vehicle intradermally injected into the other forearm
627650|NCT02639052|E1|Reported Event|Botox|10 units of Botox intradermally injected into one forearm
627651|NCT02638129|B3|Baseline|Total|Total of all reporting groups
627698|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627839|NCT02632812|E1|Reported Event|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
627652|NCT02638129|B2|Baseline|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
627653|NCT02638129|B1|Baseline|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
627654|NCT02638129|P2|Participant Flow|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
627655|NCT02638129|P1|Participant Flow|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
627656|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
627657|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
627658|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
627659|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
627660|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
627661|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
627662|NCT02638129|O2|Outcome|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
627699|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627700|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627663|NCT02638129|O1|Outcome|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
627664|NCT02638129|E2|Reported Event|Placebo|"Naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, one tablet in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone/bupropion placebo-matching tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Placebo: Naltrexone HCl/bupropion HCl placebo-matching tablets"
627665|NCT02638129|E1|Reported Event|Naltrexone/Bupropion|"Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet, in the morning (AM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, one tablet in the AM and one in the evening (PM), daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and one in the PM, daily, for 1 week, followed by naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets, orally, two tablets in the AM and two in the PM, daily, for up to 6 years.~Naltrexone HCl/Bupropion HCl ER: Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets"
627666|NCT02638051|B3|Baseline|Total|Total of all reporting groups
627667|NCT02638051|B2|Baseline|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
627668|NCT02638051|B1|Baseline|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
627669|NCT02638051|P2|Participant Flow|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter was occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
627670|NCT02638051|P1|Participant Flow|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
627671|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
627672|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
627673|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
627701|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627702|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627703|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627674|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
627675|NCT02638051|O2|Outcome|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
627676|NCT02638051|O1|Outcome|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
627677|NCT02638051|E2|Reported Event|Control Group|"IPCI: CDDP (30-60 mg) with 5FU (500-600 mg/sqm of body surface), both dissolved in 100 mL of normal saline, after abdominal paracentesis and catheterization with following closed drainage of the ascites up to small amount of remaining liquid. After IPCI, the catheter occluded. Administered biweekly during four weeks of the course, totally two times.~IPCI (CDDP+5FU): Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm)."
627678|NCT02638051|E1|Reported Event|Study Group|"Modulated Electro-Hyperthermia (mEHT): 150 Watt x 60 min/session every 2nd day for 4 weeks (14 sessions); TCM Herbal Decoction: Shi Pi Decoction administered orally twice a day (200 mL x 2) 30 min after breakfast and supper, for 4 weeks.~Modulated Electro-Hyperthermia (mEHT): MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.~TCM Herbal Decoction (Shi Pi): Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang."
627679|NCT02637063|B4|Baseline|Total|Total of all reporting groups
627680|NCT02637063|B3|Baseline|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627681|NCT02637063|B2|Baseline|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627682|NCT02637063|B1|Baseline|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627683|NCT02637063|P3|Participant Flow|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627684|NCT02637063|P2|Participant Flow|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627685|NCT02637063|P1|Participant Flow|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627686|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627687|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627688|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627689|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627690|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627691|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627692|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627704|NCT02637063|O3|Outcome|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
629139|NCT02576639|O2|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
627705|NCT02637063|O2|Outcome|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627706|NCT02637063|O1|Outcome|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627707|NCT02637063|E3|Reported Event|Usual Care|"No intervention beyond the participants' personal medical care.~Usual care: No intervention beyond participants' own medical care."
627708|NCT02637063|E2|Reported Event|BlipHub Mobile-web App + Health Coaching|"Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app + health coaching: Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627709|NCT02637063|E1|Reported Event|BlipHub Mobile-web App|"Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.~BlipHub mobile-web app: Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss."
627710|NCT02635828|B1|Baseline|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
627711|NCT02635828|P1|Participant Flow|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
627712|NCT02635828|O1|Outcome|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
627713|NCT02635828|O1|Outcome|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
627714|NCT02635828|E1|Reported Event|Triple Therapy PONV Prohylaxis|"At induction of anesthesia, a triple therapy of palonosetron 0.075 mg IV, dexamethasone 10 mg IV and promethazine 25 mg IV was given as PONV prophylaxis.~Palonosetron 0.075 mg IV: At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.~Dexamethasone 10 mg IV: At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.~Promethazine 25 mg IV: At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis."
627715|NCT02635425|B3|Baseline|Total|Total of all reporting groups
627716|NCT02635425|B2|Baseline|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
627717|NCT02635425|B1|Baseline|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
627718|NCT02635425|P2|Participant Flow|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
627719|NCT02635425|P1|Participant Flow|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
627720|NCT02635425|O2|Outcome|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
627721|NCT02635425|O1|Outcome|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
627722|NCT02635425|E2|Reported Event|Full Eggs Collection|"Aspiration of all eggs~Full eggs collection: vaginal US"
627723|NCT02635425|E1|Reported Event|7 Eggs Collection|"Aspiration of 7 eggs only~7 eggs collection: vaginal US"
627724|NCT02634073|B1|Baseline|All Treatment Groups Combined|Sixteen participants were randomized to receive one of the following 4 treatment sequences : Treatment sequence 1 : ABCD; Treatment sequence 2: DABC; Trearment sequence 3: BCDA; Treatment sequence 4: CDAB; where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g.
627725|NCT02634073|P4|Participant Flow|Treatment Sequence 4: DCAB|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
627726|NCT02634073|P3|Participant Flow|Treatment Sequence 3: CBDA|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
627727|NCT02634073|P2|Participant Flow|Treatment Sequence 2: BACD|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
627728|NCT02634073|P1|Participant Flow|Treatment Sequence 1: ADBC|Participants were randomized to receive a single dose of each of the four treatments where A: Lamivudine 300 mg, B: Lamivudine 300 mg+ Sorbitol 3.2 g, C: Lamivudine 300 mg+ Sorbitol 10.2 g, D: Lamivudine 300 mg+ Sorbitol 13.4 g. All doses were administered after an overnight fast and there was >=7days washout between each period
627729|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627730|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627731|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627732|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627733|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627734|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627735|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627736|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627737|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627738|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627739|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627740|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627741|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627742|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627743|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627744|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627745|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627746|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627747|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627748|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627749|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627840|NCT02630563|B1|Baseline|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
627750|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627751|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627752|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627753|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627754|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627755|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627756|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627757|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627758|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627759|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627760|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627761|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627762|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627763|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627764|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627765|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627766|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627767|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627768|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627769|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627870|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
629211|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
627770|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627771|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627772|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627773|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627774|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627775|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627776|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627777|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627778|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627779|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627780|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627781|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627782|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627783|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627784|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627785|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627786|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627787|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627788|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627789|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627871|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
629212|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
627790|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627791|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627792|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627793|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627794|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627795|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627796|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627797|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627798|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627799|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627800|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627801|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627802|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627803|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627804|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627805|NCT02634073|O4|Outcome|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627806|NCT02634073|O3|Outcome|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627807|NCT02634073|O2|Outcome|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627808|NCT02634073|O1|Outcome|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627809|NCT02634073|E4|Reported Event|D: Lamivudine 300 mg + Sorbitol 13.4 g|After overnight fasting, participants received a single dose of treatment D: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 13.4 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627872|NCT02629354|E2|Reported Event|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
629213|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
627810|NCT02634073|E3|Reported Event|C: Lamivudine 300 mg + Sorbitol 10.2 g|After overnight fasting, participants received a single dose of treatment C: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 10.2 g in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627811|NCT02634073|E2|Reported Event|B: Lamivudine 300 mg + Sorbitol 3.2 g|After overnight fasting, participants received a single dose of treatment B: lamivudine 300 mg (30 mL of 10 mg/mL oral solution) and an oral solution containing sorbitol 3.2 grams (g) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627812|NCT02634073|E1|Reported Event|A: Lamivudine 300 mg|After overnight fasting, participants received a single dose of treatment A: lamivudine 300 milligram (mg) (30 millilitre (mL) of 10 mg/mL oral solution) in one of the four treatment periods according to randomisation. There was a washout period of 7 days between the doses.
627813|NCT02633787|B1|Baseline|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
627814|NCT02633787|P1|Participant Flow|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
627815|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
627816|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
627817|NCT02633787|O1|Outcome|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 (NCT01442675) and were enrolled in MTA00093.
627818|NCT02633787|E1|Reported Event|All Subjects; Menactra Vaccine|Participants who received a booster dose of Menactra vaccine in trial MTA77 and were enrolled in MTA00093.
627819|NCT02632812|B3|Baseline|Total|Total of all reporting groups
627820|NCT02632812|B2|Baseline|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
627821|NCT02632812|B1|Baseline|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
627822|NCT02632812|P2|Participant Flow|Placebo|"Placebo effervescent granules (oral) Twice daily~Placebo effervescent granules~Naproxen tablet"
627823|NCT02632812|P1|Participant Flow|Rebamipide 200 mg|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg)~Rebamipide effervescent granules~Naproxen tablet"
627824|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627825|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627826|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627827|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627828|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627829|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627830|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627831|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627832|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627833|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627834|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627835|NCT02632812|O1|Outcome|Rebamipide & Naproxen|"Rebamipide 100 mg effervescent granules (oral) Twice daily (total dose = 200 mg) for 7 days~Rebamipide effervescent granules: Rebamipide effervescent granules 100mg (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627836|NCT02632812|O2|Outcome|Placebo & Naproxen|"Sugar pill manufactured to mimic Rebamipide 100 mg effervescent granules (oral) Twice daily for 7 days~Placebo effervescent granules: Placebo effervescent granules (oral), twice daily for 7 days~Naproxen tablet: Naproxen tablet 550mg (tablet), twice daily for 7 days"
627873|NCT02629354|E1|Reported Event|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627874|NCT02628938|B4|Baseline|Total|Total of all reporting groups
627841|NCT02630563|P1|Participant Flow|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
627842|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
627843|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16.
627844|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
627845|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
627846|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
627847|NCT02630563|O1|Outcome|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
627848|NCT02630563|E1|Reported Event|Drug MMF|Participants receiving drug MMF twice daily along with stable concomitant doses of cyclosporine (for at least 2 full days) and corticosteroids as per center practice for at least 7 days prior to Pharmacokinetic (PK) sampling were observed up to Day 16
627849|NCT02629354|B3|Baseline|Total|Total of all reporting groups
627850|NCT02629354|B2|Baseline|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
627851|NCT02629354|B1|Baseline|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
627852|NCT02629354|P2|Participant Flow|Test - Ref|Subjects received the test product (Test) which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a FDC under fed conditions. After a washout period of at least 6 calendar days, the subjects received the reference product (Ref), which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
627853|NCT02629354|P1|Participant Flow|Ref - Test|Subjects received the reference product (Ref) which was a single oral dose (1 film-coated tablet) of 400 milligram (mg) ibuprofen (equivalent to 684 mg ibuprofen lysinate, trade name: Dolormin® Extra) under fed conditions. After a washout period of at least 6 calendar days, the subjects received the test product (Test), which was a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine in a film coated tablet as a fixed dose combination (FDC), under fed conditions. Finally the subjects had a follow-up phase of 72 hours.
627854|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627855|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627856|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627857|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627858|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627859|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627860|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627861|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627862|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627863|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627864|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627865|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627866|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627867|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
627868|NCT02629354|O2|Outcome|Test Product|Subjects received a single oral dose of 400 mg ibuprofen acid and 100 mg caffeine as a FDC under fed condition.
627869|NCT02629354|O1|Outcome|Reference Product|Subjects received a single oral dose of 400 mg ibuprofen (trade name: Dolormin® Extra), under fed condition.
629848|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
627875|NCT02628938|B3|Baseline|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
627876|NCT02628938|B2|Baseline|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
627877|NCT02628938|B1|Baseline|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
627878|NCT02628938|P3|Participant Flow|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
627879|NCT02628938|P2|Participant Flow|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
627880|NCT02628938|P1|Participant Flow|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
627881|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
627882|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
627883|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
627884|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
627885|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
627886|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
627887|NCT02628938|O3|Outcome|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
627888|NCT02628938|O2|Outcome|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
627889|NCT02628938|O1|Outcome|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
627890|NCT02628938|E3|Reported Event|Chlorohexidine Gluconate Mouth Wash|"0.2% mouth wash aqueous solution (Oraxine ®) 5 ml twice a day for 7 days~Chlorohexidine gluconate: 5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days"
627891|NCT02628938|E2|Reported Event|Miswak Sticks|"Sticks twice a day for 7 days~Miswak stick: Miswak stick twice a day for 7 days"
627892|NCT02628938|E1|Reported Event|Miswak Extract Mouth Wash|"50% mouthwash aqueous solution 5ml twice a day for 7 days~Miswak extract mouth wash: 50% Miswak extract mouth wash (5ml) twice a day for 7 days"
627893|NCT02628418|B3|Baseline|Total|Total of all reporting groups
627894|NCT02628418|B2|Baseline|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific Hand Rehabilitation (SHR) performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627895|NCT02628418|B1|Baseline|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627896|NCT02628418|P2|Participant Flow|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627897|NCT02628418|P1|Participant Flow|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627917|NCT02628106|B1|Baseline|Lipo-prostaglandin E1|"all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days.~Lipo-PGE1: all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days"
627898|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627899|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627900|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627901|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627902|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist. GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627903|NCT02628418|O1|Outcome|Gloreha Group|"TThe patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627904|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627905|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627906|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627907|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation (SHR) performed by physiotherapist GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR on performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627908|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627909|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627910|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627911|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627912|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627913|NCT02628418|O2|Outcome|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation (GR)~Specific hand rehabilitation performed by physiotherapist (SHR) GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627914|NCT02628418|O1|Outcome|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept.~SHR by Gloreha device: Each training session consisted of six parts:~1.A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min); 2.7 min of a number sequence (counting from one to five); 3.A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min) 4.A sequence of wave-like finger movements (7 min) 5.A sequence of fist opening/closing (7 min) 6.A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
627915|NCT02628418|E2|Reported Event|Control Group|"The patients in the Control Group underwent to following interventions:~General Rehabilitation~Specific hand rehabilitation performed by physiotherapist~General Rehabilitation: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~Specific hand rehabilitation performed by physiotherapist: The activities were:~Flexion-extension of the fingers (10 min);~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);~Adduction and abduction of the fingers (10 min);~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
627916|NCT02628418|E1|Reported Event|Gloreha Group|"The patients in the Gloreha Group underwent to following interventions:~General Rehabilitation (GR)~Specific Hand Rehabilitation (SHR) by Gloreha device~GR: All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.~SHR by Gloreha device: Each training session consisted of six parts:~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);~7 min of a number sequence (counting from one to five);~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)~A sequence of wave-like finger movements (7 min)~A sequence of fist opening/closing (7 min)~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
629214|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
627918|NCT02628106|P1|Participant Flow|Diabetic Nephropathy,Chronic Kidney Disease|all patients receivedlipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
627919|NCT02628106|O1|Outcome|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
627920|NCT02628106|E1|Reported Event|Diabetic Nephropathy,Chronic Kidney Disease|all patients received lipo-prostaglandin E1,10ug per day, iv for 14 consecutive days.renal hypoxia in patients with diabetic nephropathy was improves evaluate via blood oxygenation level dependent magnetic resonance imaging
627921|NCT02627144|B1|Baseline|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627922|NCT02627144|P1|Participant Flow|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627923|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627924|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627925|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627926|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627927|NCT02627144|O1|Outcome|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627928|NCT02627144|E1|Reported Event|Advanced and/or Metastatic RCC Participants|Participants with metastatic renal cell cancer (mRCC) who were treated with bevacizumab at the recommended dose of 10 milligram per kilogram (mg/kg) of body weight once every 2 weeks as an intravenous infusion, in combination with interferon alpha-2a at the recommended starting dose of 9 million international units (MIU) 3 times a week until disease progression were observed. No diagnostic or therapeutic interventions were given other than used in normal daily routine.
627929|NCT02627001|B3|Baseline|Total|Total of all reporting groups
627930|NCT02627001|B2|Baseline|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a Nu-Mask Intraoral Airway Device.~Bag Valve Mask: Conventional bag valve mask"
627931|NCT02627001|B1|Baseline|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. The Medic then performs the same procedures using a standard bag valve mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
627932|NCT02627001|P2|Participant Flow|Standard Bag Valve Mask First, Then Numask Intraoral Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using an intraoral mask.~Bag Valve Mask: Conventional bag valve mask"
627933|NCT02627001|P1|Participant Flow|NuMask Intraoral Mask First, Then Standard Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each. After a 5 minute rest period, the subject performs the same procedures using a conventional cuffed face mask.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
627934|NCT02627001|O2|Outcome|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
629849|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
627935|NCT02627001|O1|Outcome|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
627936|NCT02627001|E2|Reported Event|Bag Valve Mask|"A United States Army Combat Medic uses a single hand technique to hold a conventional bag valve mask on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~Bag Valve Mask: Conventional bag valve mask"
627937|NCT02627001|E1|Reported Event|NuMask Intraoral Airway Device|"A United States Army Combat Medic uses a single hand technique to hold a Nu-Mask Intraoral Airway Device on a cadaver while an Impact 731 ventilator delivers 10 standardized breaths with tidal volumes of 750 ml each.~NuMask Intraoral Airway Device: NuMask Intraoral Airway Device"
627938|NCT02625844|B1|Baseline|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
627939|NCT02625844|P1|Participant Flow|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
627940|NCT02625844|O1|Outcome|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
627941|NCT02625844|E1|Reported Event|Erythropoiesis Stimulating Agents (ESAs)|Healthcare personnel performing anemia care for patients.
627942|NCT02625220|B1|Baseline|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
627943|NCT02625220|P1|Participant Flow|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
627944|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
627945|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
627946|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
627947|NCT02625220|O1|Outcome|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
627948|NCT02625220|E1|Reported Event|Prototype Toric Lens Senofilcon A|All subjects in this study were dispensed the prototype toric lens senofilcon A in this study.
627949|NCT02625207|B5|Baseline|Total|Total of all reporting groups
627950|NCT02625207|B4|Baseline|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627951|NCT02625207|B3|Baseline|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
627952|NCT02625207|B2|Baseline|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627953|NCT02625207|B1|Baseline|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
627954|NCT02625207|P4|Participant Flow|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627955|NCT02625207|P3|Participant Flow|Part 1 and 2: Cohort 3 - Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
627956|NCT02625207|P2|Participant Flow|Part 1: Cohort 2 - One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627957|NCT02625207|P1|Participant Flow|Part 1 and Part 2: Cohort 1 -No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 milligram (mg) tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1, followed by maraviroc 150 mg tablet once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
627958|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
627959|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
627960|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627961|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627962|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627963|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627964|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
629215|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
627965|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
627966|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627967|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627968|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627969|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627970|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
627971|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
627972|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627973|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627974|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627975|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627976|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
627977|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
627978|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627979|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627980|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627981|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627982|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627983|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627984|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627985|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627986|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627987|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627988|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627989|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627990|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627991|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627992|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627993|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628065|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
627994|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627995|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627996|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627997|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627998|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
627999|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628000|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628001|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628002|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628003|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628004|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628005|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628006|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628007|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628008|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628009|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628010|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628011|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628012|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628013|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628014|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628015|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
628016|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628017|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628018|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628019|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628020|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
628021|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
628022|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
629850|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
628023|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628024|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628025|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628026|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628027|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628028|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628029|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628030|NCT02625207|O2|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2.
628031|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628032|NCT02625207|O4|Outcome|Cohort 4- No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628033|NCT02625207|O3|Outcome|Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628034|NCT02625207|O2|Outcome|Cohort 2- One CYP3A5*1 Allele|African-American participants with one CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628035|NCT02625207|O1|Outcome|Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628036|NCT02625207|E6|Reported Event|Part 2: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628037|NCT02625207|E5|Reported Event|Part 2: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 150 mg tablet orally once daily along with darunavir/cobicistat 800/150 mg tablet once daily from Day 1 to Day 10 in Part 2 .
628038|NCT02625207|E4|Reported Event|Part 1: Cohort 4 - No CYP3A5*1 Alleles|Caucasian participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628039|NCT02625207|E3|Reported Event|Part 1: Cohort 3- Two CYP3A5*1 Alleles|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628040|NCT02625207|E2|Reported Event|Part 1: Cohort 2- One CYP3A5*1 Allele|African-American participants with two CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628041|NCT02625207|E1|Reported Event|Part 1: Cohort 1- No CYP3A5*1 Alleles|African-American participants with no CYP3A5*1 alleles, received maraviroc 300 mg tablet orally twice daily from Day 1 to Day 4 and once only in the morning of Day 5 in Part 1.
628042|NCT02624791|B1|Baseline|All Study Participants|
628043|NCT02624791|P6|Participant Flow|Lens Sequence 6|Toric; Sphere; None
628044|NCT02624791|P5|Participant Flow|Lens Sequence 5|Toric; None; Sphere
628045|NCT02624791|P4|Participant Flow|Lens Sequence 4|Sphere; Toric; None
628046|NCT02624791|P3|Participant Flow|Lens Sequence 3|Sphere; None; Toric
628047|NCT02624791|P2|Participant Flow|Lens Sequence 2|None; Toric; Sphere
628048|NCT02624791|P1|Participant Flow|Lens Sequence 1|None; Sphere; Toric
628049|NCT02624791|O1|Outcome|Contact Lens Rx|All study participants
628050|NCT02624791|O1|Outcome|Contact Lens Rx|All study participants
628051|NCT02624791|E1|Reported Event|Contact Lens Rx|None; Sphere; Toric
628052|NCT02621034|B4|Baseline|Total|Total of all reporting groups
628053|NCT02621034|B3|Baseline|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
628054|NCT02621034|B2|Baseline|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
628055|NCT02621034|B1|Baseline|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
628056|NCT02621034|P3|Participant Flow|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
628057|NCT02621034|P2|Participant Flow|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
628058|NCT02621034|P1|Participant Flow|k File|"hand instrumentation~k file: hand instrumentation"
628059|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
628060|NCT02621034|O2|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
628061|NCT02621034|O1|Outcome|Control|"K-file hand instrumentation~Control: K-file hand instrumentation"
628062|NCT02621034|O2|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
628063|NCT02621034|O1|Outcome|Reciproc|"rotary reciprocating protocol~Reciproc: reciprocating rotary instrument"
628064|NCT02621034|O3|Outcome|One Shape|"one shape continuous rotation protocol~One shape: full rotation protocol"
628071|NCT02619812|B4|Baseline|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
628072|NCT02619812|B3|Baseline|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
628073|NCT02619812|B2|Baseline|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
628074|NCT02619812|B1|Baseline|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
628075|NCT02619812|P4|Participant Flow|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
628076|NCT02619812|P3|Participant Flow|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
628077|NCT02619812|P2|Participant Flow|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
628078|NCT02619812|P1|Participant Flow|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
628079|NCT02619812|O4|Outcome|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
628080|NCT02619812|O3|Outcome|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
628081|NCT02619812|O2|Outcome|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
628082|NCT02619812|O1|Outcome|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
628083|NCT02619812|O4|Outcome|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
628084|NCT02619812|O3|Outcome|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
628085|NCT02619812|O2|Outcome|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
628086|NCT02619812|O1|Outcome|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
628087|NCT02619812|E4|Reported Event|Group D: Double Placebo|Double Placebo: Double placebo twice per day (Subjects took a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
628088|NCT02619812|E3|Reported Event|Group C: Colesevelam + SBI|Colesevelam 1.875 g + SBI 10 grams twice per day.
628089|NCT02619812|E2|Reported Event|Group B: Colesevelam + Placebo|Colesevelam 1.875 g + Placebo twice per day
628090|NCT02619812|E1|Reported Event|Group A: SBI + Placebo|SBI 10 grams + placebo twice per day.
628091|NCT02619799|B3|Baseline|Total|Total of all reporting groups
628092|NCT02619799|B2|Baseline|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628093|NCT02619799|B1|Baseline|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628094|NCT02619799|P2|Participant Flow|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628095|NCT02619799|P1|Participant Flow|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628096|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628097|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628098|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628099|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628121|NCT02618772|B1|Baseline|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
629851|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
628100|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628101|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628102|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628103|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628104|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628105|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628106|NCT02619799|O2|Outcome|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628107|NCT02619799|O1|Outcome|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628108|NCT02619799|E2|Reported Event|GROUP B(MIDAZOLAM GROUP)|"MIDAZOLAM GROUP received 1mg(0.2ml) of intrathecal midazolam diluted to 1ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~Intrathecal midazolam: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628109|NCT02619799|E1|Reported Event|GROUP A(MAGNESIUM GROUP)|"MAGNESIUM GROUP received 50 mg(0.1 ml) of intrathecal magnesium sulphate diluted to 1 ml with 0.9% normal saline combined with 14-16 ml of epidural 0.75% ropivacaine as a part of combined spinal epidural technique at L2-L3/L3-L4 interspace.~intrathecal magnesium sulphate,: comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine"
628110|NCT02619591|B3|Baseline|Total|Total of all reporting groups
628111|NCT02619591|B2|Baseline|Ultrasound Imaging - Multiple Views|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
628112|NCT02619591|B1|Baseline|Ultrasound Imaging - Single View|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging: views of a hemithorax was obtained using the Zonare Ultrasound machine."
628113|NCT02619591|P2|Participant Flow|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
628114|NCT02619591|P1|Participant Flow|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
628115|NCT02619591|O2|Outcome|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
628116|NCT02619591|O1|Outcome|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
628117|NCT02619591|E2|Reported Event|"Device - Ultrasound Imaging - Multiple Views"|"Ultrasound performed on patient. Multiple view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Multiple Views: Multiple views of a hemithorax was obtained using the Zonare Ultrasound machine."
628118|NCT02619591|E1|Reported Event|"Device - Ultrasound Imaging - Single View"|"Ultrasound performed on patient. A single view of each hemithorax with ultrasound was performed on patient~Ultrasound Imaging Technique - Single View: A single view of a hemithorax was obtained using the Zonare Ultrasound machine."
628119|NCT02618772|B3|Baseline|Total|Total of all reporting groups
628120|NCT02618772|B2|Baseline|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628122|NCT02618772|P2|Participant Flow|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628123|NCT02618772|P1|Participant Flow|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628124|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628125|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628126|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628127|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628128|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628129|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628130|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628131|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628132|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628133|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628134|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628135|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628136|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628137|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628138|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628139|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628140|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628141|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628142|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628143|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628144|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628145|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628225|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
629852|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
628146|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628147|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628148|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628149|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628150|NCT02618772|O2|Outcome|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628151|NCT02618772|O1|Outcome|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628152|NCT02618772|E2|Reported Event|Intranasal Midazolam|"0.08ml/kg (0.4mg/kg of 5mg/ml IV solution) intranasal midazolam, to a maximum of 2ml (10mg), with an atomizer MAD-300~Midazolam: Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair"
628153|NCT02618772|E1|Reported Event|Intranasal Saline|"0.08ml/kg of saline to a maximum of 2ml intranasally with an atomizer MAD-300~Saline: Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo, 10 minutes prior to laceration repair"
628154|NCT02617888|B3|Baseline|Total|Total of all reporting groups
628155|NCT02617888|B2|Baseline|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
628156|NCT02617888|B1|Baseline|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
628157|NCT02617888|P2|Participant Flow|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
628158|NCT02617888|P1|Participant Flow|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
628159|NCT02617888|O2|Outcome|Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
628160|NCT02617888|O1|Outcome|No Breast Shields|"Within female subset, randomization to wearing bismuth breast shield or not wearing bismuth breast shield (standard of care).~CCTA: Breast shield placement (randomized) among women."
628161|NCT02617888|E2|Reported Event|CCTA No Breast Shields|Within female subset, randomization to not wearing bismuth breast shield (standard of care).
628162|NCT02617888|E1|Reported Event|CCTA Breast Shields|Within female subset, randomization to wearing bismuth breast shield.
628163|NCT02617784|B3|Baseline|Total|Total of all reporting groups
628164|NCT02617784|B2|Baseline|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628165|NCT02617784|B1|Baseline|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628166|NCT02617784|P2|Participant Flow|Oseltamivir With CAPD|Participants on continuous ambulatory peritoneal dialysis (CAPD) received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628167|NCT02617784|P1|Participant Flow|Oseltamivir With HD|Participants on hemodialysis (HD) received 9 doses of 30-milligram (mg) oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628168|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628169|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628170|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628171|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628172|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628173|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628174|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628294|NCT02614222|B3|Baseline|Total|Total of all reporting groups
628175|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628176|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628177|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628178|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628179|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628180|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628181|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628182|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628183|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628184|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628185|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628186|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628187|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628188|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628189|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628190|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628191|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628192|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628193|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628194|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628195|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628196|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628197|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628198|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628295|NCT02614222|B2|Baseline|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628199|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628200|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628201|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628202|NCT02617784|O1|Outcome|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628203|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628204|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628205|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628206|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628207|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628208|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628209|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628210|NCT02617784|O1|Outcome|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628211|NCT02617784|E2|Reported Event|Oseltamivir With CAPD|Participants on CAPD received 6 doses of 30-mg oseltamivir oral suspension, given once weekly after dialysis exchange. All CAPD participants underwent routine CAPD sessions (four exchanges per 24 hours) during the 6-week study period.
628212|NCT02617784|E1|Reported Event|Oseltamivir With HD|Participants on HD received 9 doses of 30-mg oseltamivir oral suspension, given 1 hour after completion of alternating HD sessions. All HD participants were planned to receive 19 routine HD sessions (three per week) during the 6.5-week study period.
628213|NCT02616523|B4|Baseline|Total|Total of all reporting groups
628214|NCT02616523|B3|Baseline|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628215|NCT02616523|B2|Baseline|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628216|NCT02616523|B1|Baseline|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628217|NCT02616523|P3|Participant Flow|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628218|NCT02616523|P2|Participant Flow|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628219|NCT02616523|P1|Participant Flow|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628220|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
628221|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
628222|NCT02616523|O1|Outcome|Dexmedetomidine|Participants received dexmedetomidine infusion intraoperatively 0,5 mcg/kg/h
628223|NCT02616523|O3|Outcome|Placebo|Participants received fentanyl boluses during the operation
628224|NCT02616523|O2|Outcome|Lidocaine|Participants received lidocaine infusion intraoperatively 1,5 mg/kg/h
629853|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
628226|NCT02616523|O3|Outcome|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628227|NCT02616523|O2|Outcome|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628228|NCT02616523|O1|Outcome|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628229|NCT02616523|E3|Reported Event|Placebo|"The placebo group will receive intravenous infusion of normal saline only.~placebo: The participants will be given infusion of normal saline intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628230|NCT02616523|E2|Reported Event|Lidocaine|"Lidocaine group will receive lidocaine infusion 1,5 mg/kg/h during the laparoscopic intestine resection.~Lidocaine: The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628231|NCT02616523|E1|Reported Event|Dexmedetomidine|"The investigators will compare fentanyl consumption in participants undergoing laparoscopic intestine resection intra and postoperatively. Dexmedetomidine group will receive dexmedetomidine infusion 0,5 mcg/kg/h beside boluses of fentanyl.~Dexmedetomidine: The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.~Fentanyl: Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50."
628232|NCT02615717|B3|Baseline|Total|Total of all reporting groups
628233|NCT02615717|B2|Baseline|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
628234|NCT02615717|B1|Baseline|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
628235|NCT02615717|P2|Participant Flow|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
628236|NCT02615717|P1|Participant Flow|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
628237|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
628238|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
628239|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
628394|NCT02611765|O2|Outcome|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
628240|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
628241|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
628242|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
628243|NCT02615717|O2|Outcome|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
628244|NCT02615717|O1|Outcome|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
628245|NCT02615717|E2|Reported Event|Attentional Control Condition|"Participants will have four 20-minute in-lab treatment conditions across two weeks. Within the Attention Bias Modification control sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target appears in the location of the neutral word in 50% of the trials. Complete Stroop and 3-back task, etc.~Attention Bias Modification: comparison of treatment versus control"
628246|NCT02615717|E1|Reported Event|Attentional Bias Modification|"In the ABM treatment condition, participants will have four 20-minute in-lab treatment conditions across two weeks. Within these Attention Bias Modification sessions, participants will be presented with a fixation cross for 500 ms. The fixation cross will then be replaced with a word pair consisting of either a threat/neutral pair or a neutral/neutral word for 500 ms, followed by a probe in the location of one of the two words (80% threat/neutral pairs, 20% neutral/neutral pairs; the target will always appear in the location of the neutral word).~Attention Bias Modification: comparison of treatment versus control"
628247|NCT02614924|B3|Baseline|Total|Total of all reporting groups
628248|NCT02614924|B2|Baseline|Pentax AWS Videolaryngoscope Group|Randomly allocated Pentax AWS videolaryngoscope and intubated using Pentax AWS videolaryngoscope
628249|NCT02614924|B1|Baseline|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
628250|NCT02614924|P2|Participant Flow|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
628251|NCT02614924|P1|Participant Flow|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
628252|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS
628253|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
628254|NCT02614924|O2|Outcome|Pentax AWS Videolaryngoscope|randomly allocated to Pentax AWs
628255|NCT02614924|O1|Outcome|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
628256|NCT02614924|E2|Reported Event|Pentax AWS Videolaryngoscope|Randomly allocated to Pentax AWS group Pentax AWS videolaryngoscope group: Patient intubated with Pentax AWS
628257|NCT02614924|E1|Reported Event|Flexible Fibre-optic Scope|"Randomly allocated to fibreoptic group~Flexible fibreoptic scope: Patient intubated using fibreoptic scope"
628258|NCT02614586|B1|Baseline|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
628259|NCT02614586|P1|Participant Flow|Part-1: Screening Phase|Participants received 2 P50 electroencephalography (EEG) sessions, first session was conducted in the morning, and second session was conducted in the afternoon. Participants did not receive any study medication in Screening Phase (Part-1) of the study.
628393|NCT02611765|P1|Participant Flow|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
629140|NCT02576639|O1|Outcome|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
628260|NCT02614586|O1|Outcome|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
628261|NCT02614586|O1|Outcome|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
628262|NCT02614586|E1|Reported Event|Part 2: TAK-058 and Ondansetron|In Treatment Phase (Part 2) of the study, participants were planned to be randomized into 3-period cross-over treatment phase with single oral dose of 1 of the 3 regimens in each period: TAK-058, ondansetron, and placebo. Participants were planned to receive treatment in following 6 sequences: placebo, TAK-058, and ondansetron; TAK-058, placebo, and ondansetron; ondansetron, placebo, and TAK-058; placebo, ondansetron, and TAK-058; TAK-058, ondansetron, and placebo; and ondansetron, TAK-058, and placebo in intervention period 1, 2, and 3 respectively. A washout period of at least 7 days was planned to be maintained between each intervention period.
628263|NCT02614469|B3|Baseline|Total|Total of all reporting groups
628264|NCT02614469|B2|Baseline|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and will take a second dose of inosine with food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
628265|NCT02614469|B1|Baseline|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and will take a second dose of inosine without food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
628266|NCT02614469|P2|Participant Flow|Group 2, Inosine Without Food Then With Food|"Group 2 subjects will take inosine without food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine with food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
628267|NCT02614469|P1|Participant Flow|Group 1, Inosine With Food Then Without Food|"Group 1 subjects will take inosine with food on day 1 after an overnight fast and after a 7 day washout, will take a second dose of inosine without food on day 8 after an overnight fast.~Inosine: Inosine, 1000 mg"
628268|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628269|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628270|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628271|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628272|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628273|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628274|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628275|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628276|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628277|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628278|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628279|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628280|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628281|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628282|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628283|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628284|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628285|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628286|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628287|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628288|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628289|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628290|NCT02614469|O2|Outcome|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628291|NCT02614469|O1|Outcome|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628292|NCT02614469|E2|Reported Event|Inosine Fasted|Inosine, 1000 mg tablet, in fasted condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628293|NCT02614469|E1|Reported Event|Inosine Fed|Inosine, 1000 mg tablet, in fed condition, orally once on Day 1 in Period 1 or Day 8 in Period 2.
628296|NCT02614222|B1|Baseline|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628297|NCT02614222|P2|Participant Flow|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628298|NCT02614222|P1|Participant Flow|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628299|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628300|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628301|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628302|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628303|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628304|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628305|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628306|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628307|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628308|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628309|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628310|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628311|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628312|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628313|NCT02614222|O2|Outcome|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628314|NCT02614222|O1|Outcome|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628315|NCT02614222|E2|Reported Event|Peripheral Nerve Block Without CAIG|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628316|NCT02614222|E1|Reported Event|Peripheral Nerve Block With CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Peripheral Nerve Blocks with CAIG: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628317|NCT02613910|B1|Baseline|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628318|NCT02613910|P1|Participant Flow|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628319|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628320|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628321|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628322|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628323|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628324|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
629141|NCT02576639|E5|Reported Event|CNP520 85mg|CNP520 85 mg was taken qd orally for 13 weeks.
628325|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628326|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628327|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628328|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628329|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628330|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628331|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628332|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628385|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
629142|NCT02576639|E4|Reported Event|CNP520 35mg|CNP520 35 mg was taken qd orally for 13 weeks.
628333|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628334|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628335|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628336|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628337|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628338|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628339|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628340|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628386|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
629143|NCT02576639|E3|Reported Event|CNP520 10mg|CNP520 10 mg was taken qd orally for 13 weeks.
628341|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628342|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628343|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628344|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628345|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628346|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628347|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628348|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628387|NCT02612064|E2|Reported Event|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
629144|NCT02576639|E2|Reported Event|CNP520 2mg|CNP520 2 mg was taken qd orally for 13 weeks.
628349|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628350|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628351|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628352|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628353|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628354|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628355|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628356|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628388|NCT02612064|E1|Reported Event|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
628389|NCT02611765|B3|Baseline|Total|Total of all reporting groups
628357|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628358|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628359|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628360|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628361|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628362|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628363|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628364|NCT02613910|O1|Outcome|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628390|NCT02611765|B2|Baseline|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
628391|NCT02611765|B1|Baseline|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
629145|NCT02576639|E1|Reported Event|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
628365|NCT02613910|E1|Reported Event|Ofatumumab|At Baseline and Week 4 visits, participants were planned to receive 40 milligrams (mg) ofatumumab SC (2 X 20 mg); and 20 mg ofatumumab SC injections every 4 weeks from Week 8 through Week 56. Participants planned to return to clinic 4 weeks after the last dose for a Follow-up visit (Week 60). Antihistamine 10 mg and acetaminophen/paracetamol 1 grams (g) would be given 1-2 hours before and 4 hour after each dose of ofatumumab SC injection. Acetaminophen/paracetamol 1 g were to be self administered. Prednisone/prednisolone dose were to be tapered during core study period by 1 dose level every 2 weeks to <= 10 mg/day from Baseline through Week 60. Upon completion of the core study period, participants were to enter individualized Follow-up period, where participants were to be monitored every 12 weeks for a minimum of 1 year and up to 2 years.
628366|NCT02612077|B1|Baseline|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
628367|NCT02612077|P1|Participant Flow|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
628368|NCT02612077|O1|Outcome|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
628369|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
628370|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
628371|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
628372|NCT02612077|O3|Outcome|Bevacizumab With 3rd Line Treatment|Patients treated with bevacizumab during third line treatment of chemotherapy
628373|NCT02612077|O2|Outcome|Bevacizumab With 2nd Line Treatment|Patients treated with bevacizumab during second line treatment of chemotherapy
628374|NCT02612077|O1|Outcome|Bevacizumab With 1st Line Treatment|Patients treated with bevacizumab during first line treatment of chemotherapy
628375|NCT02612077|E1|Reported Event|Observational Chemotherapy/Bevacizumab|Observed patients receiving chemotherapy with concomitant bevacizumab
628376|NCT02612064|B3|Baseline|Total|Total of all reporting groups
628377|NCT02612064|B2|Baseline|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
628378|NCT02612064|B1|Baseline|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
628379|NCT02612064|P2|Participant Flow|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
628380|NCT02612064|P1|Participant Flow|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
628381|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
628382|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
628383|NCT02612064|O2|Outcome|Sodium Monofluorophosphate|Control: Participants were instructed to apply a pea-sized dose of dentifrice containing 0.76% w/w sodium monofluorophosphate (1000 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with tap water.
628384|NCT02612064|O1|Outcome|Stannous Fluoride|Test: Participants were instructed to apply a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth’s cervical margin for the allocated time. No rinsing was permitted after direct application with treatment. For at home use, participants then brushed their whole mouth for at least 1 minute and were permitted to rinse with 5ml tap water (room temperature) for 5 seconds maximum after brushing.
628392|NCT02611765|P2|Participant Flow|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
628602|NCT02604264|O1|Outcome|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
628395|NCT02611765|O1|Outcome|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
628396|NCT02611765|E2|Reported Event|Standard Therapy|"A single intramuscular injection of 2.4 million units of benzathine penicillin G~Standard therapy: A single dose of intramuscular 2.4 million units of benzathine penicillin G"
628397|NCT02611765|E1|Reported Event|Enhanced Therapy|"Three doses of 2.4 million units of intramuscular benzathine penicillin G administered weekly (a total of 7.2 million units)~Enhanced therapy: Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units)."
628398|NCT02611154|B1|Baseline|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
628399|NCT02611154|P1|Participant Flow|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
628400|NCT02611154|O2|Outcome|Serum Testosterone - Day 19|Serum Testosterone at Day 19
628401|NCT02611154|O1|Outcome|Serum Testosterone - Day 0|Serum Testosterone at Day 0
628402|NCT02611154|O6|Outcome|5βAdiol|5βAdiol level will be measured in the urine sample.
628403|NCT02611154|O5|Outcome|5αAdiol|5αAdiol level will be measured in the urine sample.
628404|NCT02611154|O4|Outcome|Etiocholanolone|Etiocholanolone level will be measured in the urine sample.
628405|NCT02611154|O3|Outcome|Androsterone|Androsterone level will be measured in the urine sample.
628406|NCT02611154|O2|Outcome|Epitestosterone|Epitestosterone level will be measured in the urine sample.
628407|NCT02611154|O1|Outcome|Testosterone|Testosterone level will be measured in the urine sample.
628408|NCT02611154|O8|Outcome|Urine Steroid Profile - Day 42|Urine was collected at Day 42 to identify any suppression of endogenous testosterone production following administration.
628409|NCT02611154|O7|Outcome|Urine Steroid Profile - Day 35|Urine was collected at Day 35 to identify any suppression of endogenous testosterone production following administration.
628410|NCT02611154|O6|Outcome|Urine Steroid Profile - Day 30|Day 30 steroid level in urine. Urine sample analyzed within the 48-72 hour window post-administration.
628411|NCT02611154|O5|Outcome|Urine Steroid Profile - Day 29|Day 29 steroid level in urine. Urine sample analyzed within the 24-48 hour window post-administration.
628412|NCT02611154|O4|Outcome|Urine Steroid Profile - Day 28|Day 28 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
628413|NCT02611154|O3|Outcome|Urine Steroid Profile - Day 21|Day 21 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
628414|NCT02611154|O2|Outcome|Urine Steroid Profile - Day 13|Day 13 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
628415|NCT02611154|O1|Outcome|Urine Steroid Profile - Day 6|Day 6 steroid level in urine. Urine sample analyzed within 24 hours of dosing.
628416|NCT02611154|E1|Reported Event|Intranasal Testosterone|"All participants will be receiving intranasal testosterone and will follow the same study procedures.~Testosterone: Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks."
628417|NCT02610634|B3|Baseline|Total|Total of all reporting groups
628418|NCT02610634|B2|Baseline|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
628419|NCT02610634|B1|Baseline|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
628420|NCT02610634|P2|Participant Flow|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
628421|NCT02610634|P1|Participant Flow|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
628422|NCT02610634|O2|Outcome|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
628423|NCT02610634|O1|Outcome|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
628424|NCT02610634|E2|Reported Event|Older Adults|Aged-matched older adults (≥ 50 years old) who are cognitively intact (MoCA ≥26).
628425|NCT02610634|E1|Reported Event|Parkinson's Disease|People with Parkinson's disease (≥ 50 years old) who do not have dementia (MoCA ≥ 21).
628426|NCT02609672|B3|Baseline|Total|Total of all reporting groups
628427|NCT02609672|B2|Baseline|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628428|NCT02609672|B1|Baseline|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628471|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
628472|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
628603|NCT02604264|E2|Reported Event|Control|Standard hemodialysis end cap
628429|NCT02609672|P2|Participant Flow|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee osteoarthritis, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628430|NCT02609672|P1|Participant Flow|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628431|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628432|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628433|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628434|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628435|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628436|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628437|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628473|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
628474|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
628438|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628439|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628440|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628441|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628442|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628443|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628444|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628445|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628446|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628475|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
628476|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
628604|NCT02604264|E1|Reported Event|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
629854|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
628447|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628448|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628449|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628450|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628451|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628452|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628453|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628454|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628455|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628477|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
628478|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
628456|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628457|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628458|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628459|NCT02609672|O2|Outcome|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628460|NCT02609672|O1|Outcome|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628461|NCT02609672|E2|Reported Event|No Exercise|"The participants in this arm were asked to refrain from changing their physical activity over the 12 weeks and maintain any strategies typically used to manage knee and/or hip pain. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the no exercise group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~No Exercise: A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628462|NCT02609672|E1|Reported Event|Exercise|"The participants in this arm were asked to attend 3 group classes per week for 12 weeks taught by a certified exercise instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes included clinical mobility; pain; isometric leg strength; cardiovascular fitness; and resilience.~Exercise: A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience."
628463|NCT02609178|B1|Baseline|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
628464|NCT02609178|P6|Participant Flow|CON First, Then AVR, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: CON, AVR, FGP, a 5-min washout period would be given between each crown.
628465|NCT02609178|P5|Participant Flow|CON First, Then FGP, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: CON, FGP, AVR, a 5-min washout period would be given between each crown.
628466|NCT02609178|P4|Participant Flow|AVR First, Then CON, Then FGP|Tried in the artificial crowns for the same participant as the following sequence: AVR, CON, FGP, a 5-min washout period would be given between each crown.
628467|NCT02609178|P3|Participant Flow|AVR First, Then FGP, Then CON|Tried in the artificial crowns for the same participant as the following sequence: AVR, FGP, CON, a 5-min washout period would be given between each crown.
628468|NCT02609178|P2|Participant Flow|FGP First, Then CON, Then AVR|Tried in the artificial crowns for the same participant as the following sequence: FGP, CON, AVR, a 5-min washout period would be given between each crown.
628469|NCT02609178|P1|Participant Flow|FGP First, Then AVR, Then CON|Tried in the artificial crowns for the same participant as the following sequence: FGP, AVR, CON, a 5-min washout period would be given between each crown.
628470|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
628479|NCT02609178|O3|Outcome|CON Designed Surface|The occlusal surface of the artificial crown was fabricated based on the technicians' experience.
628480|NCT02609178|O2|Outcome|AVR Designed Surface|The occlusal surface of the artificial crown was designed by setting the virtual articulator at average values, that is, 30° for the angles of the sagittal condyle and 15° for the lateral Bennett angle, and 30° for the incisal path, respectively.
628481|NCT02609178|O1|Outcome|FGP Designed Surface|The occlusal surface of the artificial crown was designed by FGP technique.
628482|NCT02609178|E1|Reported Event|Occlusal Surface Design|use computer-aided design and computer-aided manufacturing technique (CAD/CAM) to execute different occlusal surface designs of the artificial crown, including FGP design (FGP and AVR) and conventional design (CON), and evaluate their efficacy, separately
628483|NCT02608489|B3|Baseline|Total|Total of all reporting groups
628484|NCT02608489|B2|Baseline|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628485|NCT02608489|B1|Baseline|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628486|NCT02608489|P2|Participant Flow|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628487|NCT02608489|P1|Participant Flow|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628488|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628489|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628490|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628491|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628492|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628493|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628494|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628495|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628496|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628497|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628498|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628499|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628500|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628501|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628502|NCT02608489|O2|Outcome|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628503|NCT02608489|O1|Outcome|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628504|NCT02608489|E2|Reported Event|Hyaluronate|"0.1% Sodium Hyaluronate Ophthalmic Solution~Sodium Hyaluronate (Hyalein): Hyaluronate group used sodium hyaluronate 6 times a day during study period."
628505|NCT02608489|E1|Reported Event|Diqufosol|"3% Diquafosol Tetrasodium Ophthalmic Solution~Diquafosol (Diquas): Diquafosol group used diquafosol 6 times a day during study period."
628506|NCT02606838|B1|Baseline|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
628507|NCT02606838|P1|Participant Flow|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
628508|NCT02606838|O1|Outcome|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
628509|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
629216|NCT02575911|E2|Reported Event|LenSx|All subjects treated with LASIK surgery in both eyes using LenSx® Femtosecond Laser System
628510|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
628511|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
628512|NCT02606838|O1|Outcome|Persons With Diabetes|Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (i.e., error messages), or not obtained at all.
628513|NCT02606838|E1|Reported Event|Persons With Diabetes|"Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.~Styx Lancing Device System: Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all."
628514|NCT02606734|B1|Baseline|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
628515|NCT02606734|P1|Participant Flow|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
628516|NCT02606734|O1|Outcome|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
628517|NCT02606734|E1|Reported Event|Treatment Arm|"All subjects enrolled in the trial will use the DyeVert System.~Coronary Angiography: The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases."
628518|NCT02605928|B1|Baseline|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
628519|NCT02605928|P1|Participant Flow|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
628520|NCT02605928|O1|Outcome|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
628521|NCT02605928|E1|Reported Event|BIP Needle|"Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It measures bioimpedance and detects synovial fluid during inta-articular injection.~Injeq Bioimpedance Probe (BIP) Needle: Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid."
628522|NCT02604589|B4|Baseline|Total|Total of all reporting groups
628523|NCT02604589|B3|Baseline|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628524|NCT02604589|B2|Baseline|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628525|NCT02604589|B1|Baseline|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628526|NCT02604589|P3|Participant Flow|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628527|NCT02604589|P2|Participant Flow|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
629634|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
628528|NCT02604589|P1|Participant Flow|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628529|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628530|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628531|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628532|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628533|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628534|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628535|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628536|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628537|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628538|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628539|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628540|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628541|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628542|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628543|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628544|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628545|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628546|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628547|NCT02604589|O3|Outcome|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628548|NCT02604589|O2|Outcome|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628549|NCT02604589|O1|Outcome|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628550|NCT02604589|E3|Reported Event|Bupivicaine 0.5% (HIGH DOSE)|"bupivicaine 0.5%: High dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.5% 4 ml/hr total for dual chamber catheter."
628598|NCT02604264|B1|Baseline|Treatment|ClearGuard HD end cap: The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
628551|NCT02604589|E2|Reported Event|Bupivicaine 0.25% (LOW DOSE)|"bupivicaine 0.25%: Low Dose analgesia~Standard PCA infusion 0.1 mg hydromorphone hydrochloride, every 6 minutes. Bolus 0.1 mg hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.~PLUS Infusion catheter placement. Bupivacaine 0.25% 4 ml/hr total for dual chamber catheter."
628552|NCT02604589|E1|Reported Event|PCA Only|Procedure: Standard of care - Intravenous Patient Controlled Anesthesia (PCA) 0.1 mg hydromorphone hydrochloride, every 6 minutes. Boluses of 0.1 mg IV hydromorphone for uncontrolled pain up to a maximum of 2.5 mg/hr.
628553|NCT02604550|B3|Baseline|Total|Total of all reporting groups
628554|NCT02604550|B2|Baseline|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628555|NCT02604550|B1|Baseline|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628556|NCT02604550|P2|Participant Flow|Adductor Canal Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the adductor canal
628557|NCT02604550|P1|Participant Flow|Femoral Nerve Block|Participants randomized to receive 20 milliliter (mL) of ropivacaine 0.5% in the femoral nerve.
628558|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628559|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628560|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628561|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628562|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628563|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628564|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628565|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628566|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628567|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628568|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628569|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628570|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628571|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628572|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628573|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628574|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628575|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628576|NCT02604550|O2|Outcome|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628577|NCT02604550|O1|Outcome|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628578|NCT02604550|E2|Reported Event|Adductor Canal Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the adductor canal
628579|NCT02604550|E1|Reported Event|Femoral Nerve Block|Participants randomized to receive 20mL of ropivacaine 0.5% in the femoral nerve.
628580|NCT02604407|B4|Baseline|Total|Total of all reporting groups
628581|NCT02604407|B3|Baseline|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
628582|NCT02604407|B2|Baseline|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
628583|NCT02604407|B1|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
628584|NCT02604407|P3|Participant Flow|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
628585|NCT02604407|P2|Participant Flow|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
628586|NCT02604407|P1|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
628587|NCT02604407|O3|Outcome|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
628588|NCT02604407|O2|Outcome|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
628589|NCT02604407|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
628590|NCT02604407|O3|Outcome|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
628591|NCT02604407|O2|Outcome|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 mg orally once daily for 4 weeks.
628592|NCT02604407|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
628593|NCT02604407|E3|Reported Event|SHP465 37.5 mg|Participants received SHP465 capsule of 12.5 mg during week 1 and 25 mg at week 2 followed by 37.5 mg at weeks 3 and 4 orally once daily.
628594|NCT02604407|E2|Reported Event|SHP465 12.5 mg|Participants received SHP465 capsule 12.5 milligram (mg) orally once daily for 4 weeks.
628595|NCT02604407|E1|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
628596|NCT02604264|B3|Baseline|Total|Total of all reporting groups
628597|NCT02604264|B2|Baseline|Control|Standard hemodialysis end cap
629635|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
628605|NCT02603666|B1|Baseline|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
628606|NCT02603666|P1|Participant Flow|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
628607|NCT02603666|O1|Outcome|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
628608|NCT02603666|E1|Reported Event|Elastography|"Fibroscan elastography device for evaluation of liver disease in CF patients.~Fibroscan: Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions."
628609|NCT02602223|B1|Baseline|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
628610|NCT02602223|P1|Participant Flow|Amnion Chorion Membrane & d-PTFE|"Amnion chorion membrane or d-PTFE will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane or d-PTFE over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM or d-PTFE (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed."
628611|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628612|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628613|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628614|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628645|NCT02598622|E2|Reported Event|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
628646|NCT02598622|E1|Reported Event|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
628689|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628615|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628616|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628617|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628618|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628619|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628620|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628621|NCT02602223|O2|Outcome|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628622|NCT02602223|O1|Outcome|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
629855|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
628623|NCT02602223|E2|Reported Event|d-PTFE Membrane|"dense polytetrafluoroethylene membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the Experimental side~Placing d-PTFE membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628624|NCT02602223|E1|Reported Event|Amnion Chorion Membrane|"Amnion chorion membrane will be placed over bone graft after socket preservation on randomly assigned side of the mouth i.e., contra-lateral to the active comparator.~Placing Amnion chorion membrane over grafted site: Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed"
628625|NCT02598934|B3|Baseline|Total|Total of all reporting groups
628626|NCT02598934|B2|Baseline|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
628627|NCT02598934|B1|Baseline|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
628628|NCT02598934|P2|Participant Flow|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
628629|NCT02598934|P1|Participant Flow|Ibandronate (Consult Group)|Participants received ibandronate 150-milligram (mg) tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on bone turnover marker (BTM) response.
628630|NCT02598934|O2|Outcome|Ibandronate (Non-consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and did not receive physician consultation on BTM response.
628631|NCT02598934|O1|Outcome|Ibandronate (Consult Group)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months, and received physician consultation on BTM response.
628632|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
628633|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
628634|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
628635|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
628636|NCT02598934|O1|Outcome|Ibandronate (All Participants)|"Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months.~Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group."
628637|NCT02598934|E1|Reported Event|Ibandronate (All Participants)|Participants received ibandronate 150-mg tablet once a month and a combination of calcium plus vitamin D supplement twice daily for 6 months. Depending on the physician consultation on BTM response, participants were randomized into consult group and non-consult group.
628638|NCT02598622|B3|Baseline|Total|Total of all reporting groups
628639|NCT02598622|B2|Baseline|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
628640|NCT02598622|B1|Baseline|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
628641|NCT02598622|P2|Participant Flow|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
628642|NCT02598622|P1|Participant Flow|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
628643|NCT02598622|O2|Outcome|Acetyl-L-Carnitine or Placebo|"Subjects 16-30 will be randomized to receive drug or placebo.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21.~Placebo: Placebo is taken 2 times a day for days 1 through 21."
628644|NCT02598622|O1|Outcome|Acetyl-L-Carnitine Only|"The first 15 subjects participating in this study will receive Acetyl-L-Carnitine and pharmacokinetic testing will be done.~Acetylcarnitine: Acetylcarnitine is taken 2 times a day for days 1 through 21."
629636|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
628647|NCT02598128|B1|Baseline|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
628648|NCT02598128|P4|Participant Flow|Period C: Clinical Treatment Practice + RELiZORB (Days 12-20)|Period C was the open label clinical treatment period with RELiZORB. All patients used RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
628649|NCT02598128|P3|Participant Flow|Crossover Period B: RELiZORB Then Placebo|Eligible subjects were randomized to RELiZORB then Placebo.
628650|NCT02598128|P2|Participant Flow|Crossover Period B: Placebo Then RELiZORB|Eligible subjects were randomized to Placebo then RELiZORB.
628651|NCT02598128|P1|Participant Flow|Period A: Clinical Treatment Practice (Days -7 to -1)|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
628652|NCT02598128|O1|Outcome|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
628653|NCT02598128|O2|Outcome|Control|Subjects receiving placebo at any time in the study.
628654|NCT02598128|O1|Outcome|RELiZORB|Subjects receiving RELiZORB at any time in the study.
628655|NCT02598128|O4|Outcome|Clinical Treatment Practice + RELiZORB: Period C: Days 12-20|Non-gastrointestinal adverse events during CTP+RELiZORB administration.
628656|NCT02598128|O3|Outcome|Crossover Period B: RELiZORB|Non-gastrointestinal adverse events during administration.
628657|NCT02598128|O2|Outcome|Crossover Period B: Placebo|Non-gastrointestinal adverse events during administration.
628658|NCT02598128|O1|Outcome|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
628659|NCT02598128|E3|Reported Event|Clinical Treatment Practice and Relizorb: Period C: Days 12-20|Period C was the open label clinical treatment period with RELiZORB. All patients received RELiZORB with Impact Peptide 1.5 at their normal volume as in Period A up to a maximum of 1000 mL per feeding. Patients were instructed to use the same daily dose and schedule of oral PERT taken in Period C as in Period A. There were no dietary restrictions. A gastrointestinal symptom diary was completed for 7 consecutive days. Patients received enteral feeding at home from Days 12 to 18 and returned to clinic for their end of study Day 19.
628660|NCT02598128|E2|Reported Event|Double-Blind Crossover: Period B: Days 1 to 11|Period B was the randomized, double-blind, placebo-controlled crossover period. Eligible patients were randomized in a 1:1 ratio to either Placebo-RELiZORB or RELiZORB-Placebo treatment sequences. On two separate administration Days 1 and 9, patients received 500 mL of Impact Peptide1.5 in clinic over a 4h period. Motility and acid suppression medications were discontinued 24h before arrival in clinic. No nocturnal feeding occurred between Days 1-2 and Days 9-10. During the home washout period Days 2 to 8, patients received Peptamen 1.5 for enteral nutrition up to a maximum volume of 1000 mL per feeding. Safety follow up calls were conducted on Days 2 and 10.
628661|NCT02598128|E1|Reported Event|Clinical Treatment Practice: Period A: Days -7 to -1|Period A was a 7-day baseline period. Patients received Peptamen 1.5 at their normal volume of enteral formula administration up to a maximum of 1000 mL per feeding. Current treatment practice was followed with normal use of oral pancreatic enzyme replacement therapy (PERT) during daily meals and nightly enteral feedings. A gastrointestinal symptom diary was completed for 7 consecutive days. Baseline Day -7 required a clinic visit followed by Days -6 to -1 at home.
628662|NCT02597907|B3|Baseline|Total|Total of all reporting groups
628663|NCT02597907|B2|Baseline|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
628664|NCT02597907|B1|Baseline|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
628665|NCT02597907|P2|Participant Flow|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
628666|NCT02597907|P1|Participant Flow|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
628667|NCT02597907|O2|Outcome|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
629637|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
628668|NCT02597907|O1|Outcome|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
628669|NCT02597907|E2|Reported Event|Aprepitant Plus Ramosetron|"aprepitant 80 mg ramosetron 0.3 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~Ramosetron: ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia"
628670|NCT02597907|E1|Reported Event|Aprepitant Plus Palonosetron|"aprepitant 80 mg palonosetron 0.075 mg~aprepitant: aprepitant 80 mg is given to all patients before surgery~palonosetron: palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia"
628671|NCT02597855|B3|Baseline|Total|Total of all reporting groups
628672|NCT02597855|B2|Baseline|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628673|NCT02597855|B1|Baseline|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628674|NCT02597855|P2|Participant Flow|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628675|NCT02597855|P1|Participant Flow|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months. Indocyanine green angiography was used to classify the type of PCV and evaluate the polyp closure rate.~Aflibercept: Total 4 times of intravitreal aflibercept injection was performed~Indocyanine green angiography (intraveonus indocyanine green dye): At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628676|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628677|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628678|NCT02597855|O2|Outcome|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628679|NCT02597855|O1|Outcome|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628680|NCT02597855|E2|Reported Event|Type 2 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628681|NCT02597855|E1|Reported Event|Type 1 Polypoidal Choroidal Vasculopathy|"Monthly intravitreal aflibercept injection for 3 months and 1 additional injection after 2 months from third injection.~At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure."
628682|NCT02597582|B3|Baseline|Total|Total of all reporting groups
628683|NCT02597582|B2|Baseline|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628684|NCT02597582|B1|Baseline|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628685|NCT02597582|P2|Participant Flow|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628686|NCT02597582|P1|Participant Flow|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628687|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628688|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628690|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628691|NCT02597582|O2|Outcome|Conventional Neck Dissection|"The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628692|NCT02597582|O1|Outcome|Ligusure Assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Participants were asked to take a Voren enteric-microencapsulated (Diclofenac 50 mg/capsule) capsule 3 times a day for pain relief postoperatively. An additional capsule before sleep was allowed if persistent pain was told by the patient. When intolerable pain was complained in spite of oral analgesic, pethidine (meperidine 50 mg/ampule) injection was prescribed every 6 hours.~Neck dissection: The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628693|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628694|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628695|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628696|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628697|NCT02597582|O2|Outcome|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628698|NCT02597582|O1|Outcome|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628699|NCT02597582|E2|Reported Event|Conventional Neck Dissection|The control group patients were treated using conventional cold instrument dissection, monopolar electrocautery hemostasis, and suture ligation during neck dissection.
628700|NCT02597582|E1|Reported Event|Ligusure-assisted Neck Dissection|"The study group patients were treated using the LigaSure vessel sealing system (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) for dissection and hemostasis throughout the whole procedures during neck dissection.~Ligasure small jaw (Covidien, Colorado, USA): The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device."
628701|NCT02596958|B1|Baseline|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628702|NCT02596958|P1|Participant Flow|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current summary of product characteristics (SmPC).
628703|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628704|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628705|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628706|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628751|NCT02591238|B4|Baseline|Ismoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628707|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628708|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628709|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628710|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628711|NCT02596958|O1|Outcome|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628712|NCT02596958|E1|Reported Event|Bevacizumab|Participants received bevacizumab (Avastin) in addition to platinum based chemotherapy for up to 6 cycles (21-day cycles) followed by bevacizumab as a single agent until disease progression. The dose and administration schedule was at the discretion of the treating physician and as per the recommendations given in the current SmPC.
628713|NCT02596945|B1|Baseline|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
628714|NCT02596945|P1|Participant Flow|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC) were observed for a period of 9 months.
628715|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
628716|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
628717|NCT02596945|O1|Outcome|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
628718|NCT02596945|E1|Reported Event|Peritoneal Dialysis Participants|Participants who were on peritoneal dialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion in accordance with the SmPC were observed for a period of 9 months.
628719|NCT02596620|B3|Baseline|Total|Total of all reporting groups
628720|NCT02596620|B2|Baseline|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
628721|NCT02596620|B1|Baseline|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
628722|NCT02596620|P2|Participant Flow|Triple Therapy|levofloxacin 500 mg qd, amoxicillin 1 g bid, and esomeprazole 40 mg bid
628723|NCT02596620|P1|Participant Flow|Sequential Therapy|esomeprazole 40 mg bid and amoxicillin 1 g bid for 5 days, followed by esomeprazole 40 mg bid, levofloxacin 500 mg qd, and metronidazole 500 mg tid, for 5 days
628724|NCT02596620|O2|Outcome|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
628725|NCT02596620|O1|Outcome|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
628752|NCT02591238|B3|Baseline|IIsmoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628726|NCT02596620|E2|Reported Event|Triple Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily; amoxicillin (Amolin)(500 mg) 2 tablets twice daily and levofloxacin(Cravit)(500 mg), 1 tablet once daily for 10 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm"
628727|NCT02596620|E1|Reported Event|Sequential Therapy|"Esomeprazole (Nexium)(40 mg) 1 tablet twice daily, amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 5 days followed by esomeprazole (Nexium) (40 mg) twice daily, levofloxacin(Cravit)(500 mg), 1 tablet once daily and metronidazole (Flagyl)(250 mg) 2 tablets three times daily for 5 days~Nexium: Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms~Amolin: Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm~Cravit: Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm~Flagyl: Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm"
628728|NCT02595502|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the duration of the study.
628729|NCT02595502|P2|Participant Flow|Senofilcon A/Delefilcon A/Senofilcon A|Subjects that wore the senofilcon A lens first, the delefilcon A lens second and then wore the senofilcon A lens again, third.
628730|NCT02595502|P1|Participant Flow|Delefilcon A /Senofilcon A/Delefilcon A|Subjects that wore the delefilcon A lens first, the senofilcon A lens second and then wore the delefilcon A lens again, third.
628731|NCT02595502|O2|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
628732|NCT02595502|O1|Outcome|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
628733|NCT02595502|E2|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in any of the 3 periods during the course of this study.
628734|NCT02595502|E1|Reported Event|Delefilcon A|Subjects that wore the delefilcon A lens in any of the 3 periods during the course of this study.
628735|NCT02595450|B1|Baseline|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
628736|NCT02595450|P1|Participant Flow|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
628737|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
628738|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
628739|NCT02595450|O1|Outcome|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
628740|NCT02595450|E1|Reported Event|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer were treated with erlotinib according to the product label. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported retrospective data, which already existed in the participants' medical files.
628741|NCT02594826|B3|Baseline|Total|Total of all reporting groups
628742|NCT02594826|B2|Baseline|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
628743|NCT02594826|B1|Baseline|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
628744|NCT02594826|P2|Participant Flow|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
628745|NCT02594826|P1|Participant Flow|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
628746|NCT02594826|O2|Outcome|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
628747|NCT02594826|O1|Outcome|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
628748|NCT02594826|E2|Reported Event|General Health Education Control|"General health and cancer education on nutrition, regular check-ups, tobacco use, and cancer screening.~General health education control: General health and cancer education"
628749|NCT02594826|E1|Reported Event|Culturally Appropriate Intervention|"Culturally appropriate, church-based intervention focused on cervical cancer and navigation assistance.~Culturally appropriate intervention: Church-based educational intervention combined with navigation assistance"
628750|NCT02591238|B5|Baseline|Total|Total of all reporting groups
628753|NCT02591238|B2|Baseline|IIInon-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628754|NCT02591238|B1|Baseline|IVnon-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628755|NCT02591238|P4|Participant Flow|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628756|NCT02591238|P3|Participant Flow|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628757|NCT02591238|P2|Participant Flow|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628758|NCT02591238|P1|Participant Flow|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628759|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628760|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628761|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628762|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628763|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628764|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628765|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628766|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628767|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628768|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628769|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628770|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628771|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628772|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628773|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628774|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628775|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628776|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628777|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628778|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628779|NCT02591238|O4|Outcome|I Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628780|NCT02591238|O3|Outcome|II Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628781|NCT02591238|O2|Outcome|III Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628782|NCT02591238|O1|Outcome|IV Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628783|NCT02591238|E4|Reported Event|Smoker + Melatonin|"smoker oral melatonin~smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628784|NCT02591238|E3|Reported Event|Smoker + Placebo|"smoker oral placebo~smoker oral placebo: Participants oral placebo last 2 weeks."
628785|NCT02591238|E2|Reported Event|Non-smoker + Melatonin|"non-smoker oral melatonin~non-smoker oral melatonin: Participants oral melatonin 3 mg/day last 2 weeks."
628786|NCT02591238|E1|Reported Event|Non-smoker + Placebo|"non-smoker oral placebo~non-smoker oral placebo: Participants oral placebo last 2 weeks."
628787|NCT02591056|B1|Baseline|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
628788|NCT02591056|P1|Participant Flow|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
628812|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628813|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628789|NCT02591056|O1|Outcome|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
628790|NCT02591056|E1|Reported Event|Erchonia Verju Laser + Green PRESS 8|"All subjects receive 12 combination treatments over 6 weeks (two per week) with the Erchonia® Verju™ Laser and the Green PRESS 8 devices simultaneously.~Erchonia Verju Laser + Green PRESS 8: There are 12 combined procedure administrations with the Erchonia® Verju™ Laser and the Green PRESS 8 simultaneously across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes front and 15 minutes back, followed by administration of the Green PRESS 8 to the midsection for 30 minutes. All subjects receive the combination Erchonia Verju Laser + Green PRESS 8 treatment for all 12 procedure administrations."
628791|NCT02590588|B1|Baseline|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628792|NCT02590588|P1|Participant Flow|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628793|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628794|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628795|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628796|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628797|NCT02590588|O1|Outcome|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628798|NCT02590588|E1|Reported Event|Idelalisib|"Idelalisib 100 mg twice daily with possible escalation after 3 months to 150 mg twice daily at investigator discretion.~Idelalisib: Idelalisib daily until unacceptable toxicity or disease progression."
628799|NCT02590562|B1|Baseline|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628800|NCT02590562|P1|Participant Flow|Overall Population|Participants diagnosed with rheumatoid arthritis (RA) according to American College of Rheumatology (ACR) 1987 criteria who were using biological disease-modifying anti-rheumatic drugs (DMARDs) approved in China for RA treatment were observed at the single study visit (enrollment visit).
628801|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628802|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628803|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628804|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628805|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628806|NCT02590562|O2|Outcome|Biological Agent as Combination With csDMARDs|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent with concomitant csDMARDs.
628807|NCT02590562|O1|Outcome|Biological Agent as Monotherapy|Participants were divided into two groups according to whether using biological agent (namely, biological agent concomitant with csDMARDs treatment group and biological agent without csDMARDs treatment group). This group included participants using biological agent without concomitant csDMARDs.
628808|NCT02590562|O4|Outcome|Duration of Biological Treatment >=12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=12 months.
628809|NCT02590562|O3|Outcome|Duration of Biological Treatment >=6 to <12 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=6 to <12 months.
628810|NCT02590562|O2|Outcome|Duration of Biological Treatment >=3 to <6 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment >=3 to <6 months.
628811|NCT02590562|O1|Outcome|Duration of Biological Treatment <3 Months|Participants were divided into groups with different duration of treatment according to the months of using biological agent. This group included participants with duration of biological treatment <3 months.
629206|NCT02575911|O2|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
628814|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628815|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628816|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628817|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628818|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628819|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628820|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628821|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628822|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628823|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628824|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628825|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628826|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628827|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628828|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628829|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628830|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628831|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628832|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628833|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628834|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628835|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628836|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628837|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628838|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628839|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628840|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628841|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628842|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
629207|NCT02575911|O1|Outcome|Baseline|Prior to LASIK surgery
628843|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628844|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628845|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628846|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628847|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628848|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628849|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628850|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628851|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628852|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628853|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628854|NCT02590562|O1|Outcome|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628855|NCT02590562|E1|Reported Event|Overall Population|Participants diagnosed with RA according to ACR 1987 criteria who were using biological DMARDs approved in China for RA treatment were observed at the single study visit (enrollment visit).
628856|NCT02588872|B3|Baseline|Total|Total of all reporting groups
628857|NCT02588872|B2|Baseline|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628858|NCT02588872|B1|Baseline|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628859|NCT02588872|P2|Participant Flow|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628860|NCT02588872|P1|Participant Flow|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628861|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628862|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628863|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628864|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628865|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628866|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628867|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628868|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628869|NCT02588872|O2|Outcome|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628870|NCT02588872|O1|Outcome|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628871|NCT02588872|E2|Reported Event|Platelet-rich Plasma (PRP)|"Platelet-rich plasma administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of leukocyte poor, buffer/additive free, singe spin, platelet-rich plasma averaging 4mL in volume.~Platelet-rich Plasma (PRP)"
628872|NCT02588872|E1|Reported Event|Hyaluronic Acid (HA)|"Hyaluronic acid administered as an intra-articular injection under ultrasound guidance as a series of three weekly injections to the affected knee. 3 weekly injections are of ultra high molecular weight hyaluronan (16mg) in a 2mL injection.~Hyaluronic Acid"
628873|NCT02588599|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
628874|NCT02588599|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
628875|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
628876|NCT02588599|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
628877|NCT02588599|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
628878|NCT02587819|B1|Baseline|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
628879|NCT02587819|P1|Participant Flow|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
628880|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
628881|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
628882|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
628883|NCT02587819|O1|Outcome|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days post baseline to all subjects. All (21 of 21) subjects returned for safety and tolerability assessments at days 3, 8, 15 and 29 post-Baseline. 20 of 21 patients returned for final safety assessments at 57 days post-Baseline.
628884|NCT02587819|E1|Reported Event|Treatment With BSCT|BSCT (anti-nf-P2X7) 10% Ointment topically applied twice daily for 28 consecutive days
628885|NCT02587117|B3|Baseline|Total|Total of all reporting groups
628886|NCT02587117|B2|Baseline|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
628887|NCT02587117|B1|Baseline|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
628888|NCT02587117|P2|Participant Flow|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
628889|NCT02587117|P1|Participant Flow|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
628890|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months~Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
628891|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months~lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
628892|NCT02587117|O2|Outcome|Prednisolone Group|"Prednisolone- 40 mg capsule by mouth single dose per day for 2 months~Prednisolone: Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
628893|NCT02587117|O1|Outcome|Lycopene Group|"Lycopene- 4 mg capsule by mouth single dose per day for 2 months~lycopene: Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy."
628894|NCT02587117|E2|Reported Event|Prednisolone Group|Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
628895|NCT02587117|E1|Reported Event|Lycopene Group|Lycopene- 4 mg capsule by mouth single dose per day for 2 months
628896|NCT02586506|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
628897|NCT02586506|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
629208|NCT02575911|O2|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
628898|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
628899|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
628900|NCT02586506|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
628901|NCT02586506|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled asthma medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation. Questionnaire A & B have the same questions and in the same order, they only differ with response sequence.
628902|NCT02586493|B1|Baseline|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
628903|NCT02586493|P1|Participant Flow|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
628904|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
628905|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
628906|NCT02586493|O1|Outcome|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
628907|NCT02586493|E1|Reported Event|Placebo ELLIPTA Inhaler|Participants received study placebo via ELLIPTA inhaler at Visit 1 (Day 1) for use with their current daily inhaled COPD medication(s) that were to be continued during the study. Participants were instructed to take one inhalation from the ELLIPTA inhaler once daily at the same time each day until Day 28. At Visit 2 (Day 28), participants completed Version A or B of the ELLIPTA Inhaler Questionnaire as per randomisation.
628908|NCT02585999|B1|Baseline|Xulane|"Participants exposed to contraceptive patch, Xulane.~Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
628909|NCT02585999|P1|Participant Flow|Xulane|"Participants exposed to contraceptive patch, Xulane.~Xulane Contraceptive Patch (generic version of Ortho Evra®*): Extended use (12 Weeks) of Contraceptive Patch"
628910|NCT02585999|O1|Outcome|Xulane|"All participants using the Xulane contraceptive patch for 12 continuous weeks~Xulane Contraceptive Patch: Extended use (12 weeks) of contraceptive patch"
628911|NCT02585999|O1|Outcome|Xulane|Participants exposed to Xulane Contraceptive Patch for 12 weeks of continuous use
628912|NCT02585999|E1|Reported Event|Xulane|All participants using the Xulane contraceptive patch for 12 continuous weeks
628913|NCT02584686|B3|Baseline|Total|Total of all reporting groups
628914|NCT02584686|B2|Baseline|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628915|NCT02584686|B1|Baseline|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628916|NCT02584686|P2|Participant Flow|Control Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628917|NCT02584686|P1|Participant Flow|Study Group|"The treatment group, 12 patients will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628918|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628919|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628920|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628921|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628922|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628923|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628924|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628925|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628926|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628927|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628928|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628929|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628930|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628931|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628932|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628979|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
628933|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628934|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628935|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628936|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628937|NCT02584686|O1|Outcome|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628938|NCT02584686|O2|Outcome|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628939|NCT02584686|O1|Outcome|(BTX) A|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628940|NCT02584686|E2|Reported Event|Saline Group|"The control group, 12 patients, will be injected with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) during penile colour Doppler assessment followed on a separate day with a normal saline injection.~Normal Saline: The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection."
628941|NCT02584686|E1|Reported Event|(BTX) A Group|"The treatment group will be injected intracavernously with a trimix solution for colour Doppler assessment, followed, on a separate day by 50 units of Botulinum toxin (BTX) A.~Botulinum Toxin Type A: The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A."
628942|NCT02584673|B3|Baseline|Total|Total of all reporting groups
628943|NCT02584673|B2|Baseline|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628944|NCT02584673|B1|Baseline|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628945|NCT02584673|P2|Participant Flow|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628946|NCT02584673|P1|Participant Flow|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628947|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628948|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628949|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628950|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628951|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
629035|NCT02578992|O1|Outcome|Neutral Head Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
628952|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628953|NCT02584673|O2|Outcome|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628954|NCT02584673|O1|Outcome|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628955|NCT02584673|E2|Reported Event|Control|The participants in the control group will receive the procedure with traditional ultrasound methods and equipment.
628956|NCT02584673|E1|Reported Event|CAIG|"The participants in this group (test group) will utilize the same procedure utilizing existing ultrasound equipment with the supplemental CAIG system.~Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.: The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure."
628957|NCT02582983|B1|Baseline|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
628958|NCT02582983|P1|Participant Flow|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
628959|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
628960|NCT02582983|O1|Outcome|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
628961|NCT02582983|E1|Reported Event|Enfuvirtide|Participants received Enfuvirtide 90 mg subcutaneously (SC) twice daily (BID)
628962|NCT02582970|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628963|NCT02582970|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 2 weeks (q2w) in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628964|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628965|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628966|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628967|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628968|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628969|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628970|NCT02582970|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab at a dose of 5 mg/kg q2w in combination with standard chemotherapy regimen (5-Fluorouracil/Irinotecan/Oxaliplatin) until disease progression or until termination of the study.
628971|NCT02582970|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received IV bevacizumab at a dose of 5 mg/kg q2w in combination with standard of care chemotherapy regimen until disease progression or until termination of the study.
628972|NCT02581475|B3|Baseline|Total|Total of all reporting groups
628973|NCT02581475|B2|Baseline|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
628974|NCT02581475|B1|Baseline|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
628975|NCT02581475|P2|Participant Flow|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
628976|NCT02581475|P1|Participant Flow|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
628977|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
628978|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
628980|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
628981|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
628982|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
628983|NCT02581475|O2|Outcome|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
628984|NCT02581475|O1|Outcome|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
628985|NCT02581475|E2|Reported Event|Segmental Examination Twice|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then the colonoscopy is intubated to the cecum again. The same procedure is performed in the colonic segment from hepatic flexure to splenic flexure.
628986|NCT02581475|E1|Reported Event|Extending Withdrawal Time|After cecal intubation, the colonoscopy is withdrawn to the hepatic flexure and then to the splenic flexure with an extended withdrawal time during colonoscopy.
628987|NCT02580799|B1|Baseline|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628988|NCT02580799|P1|Participant Flow|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628989|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628990|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628991|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628992|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628993|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628994|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628995|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628996|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628997|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628998|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
628999|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629000|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629001|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629002|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629003|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629004|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629005|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629006|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629007|NCT02580799|O1|Outcome|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629008|NCT02580799|E1|Reported Event|Breast Cancer Pathology Participants|Breast cancer pathology participants were evaluated for a period of 70 days.
629009|NCT02580357|B4|Baseline|Total|Total of all reporting groups
629010|NCT02580357|B3|Baseline|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629011|NCT02580357|B2|Baseline|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629034|NCT02578992|O2|Outcome|Head-lift Position|The laryngeal view was graded by the observer with modified Cormack-Lehane grade after epiglottis was identified on the video monitor.
629135|NCT02576639|O1|Outcome|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
629012|NCT02580357|B1|Baseline|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629013|NCT02580357|P3|Participant Flow|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629014|NCT02580357|P2|Participant Flow|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629015|NCT02580357|P1|Participant Flow|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629016|NCT02580357|O3|Outcome|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629017|NCT02580357|O2|Outcome|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629018|NCT02580357|O1|Outcome|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629019|NCT02580357|O3|Outcome|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629020|NCT02580357|O2|Outcome|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629021|NCT02580357|O1|Outcome|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629022|NCT02580357|E3|Reported Event|GaAlAs Laser Therapy (LLLT) 30 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 30 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 30 J/cm2 and a time of 30 seconds (15 J/cm2 per point and an application time of 15 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629023|NCT02580357|E2|Reported Event|GaAlAs Laser Therapy (LLLT) 60 J/cm²|"The irradiation was performed with a GaAlAs diode laser that continuously emitted a wavelength of 660 nm with a power of 30 mW. The patients allocated for the group 60 received the following protocol for laser application: Two (2) points of irradiation were performed using a total energy density (fluence) of 60 J/cm2 and a time of 60 seconds (30 J/cm2 per point and an application time of 30 seconds per point). During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications. The power of the equipment was calibrated prior to each application.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629024|NCT02580357|E1|Reported Event|Low Level Laser Therapy (LLLT) Sham|"The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue. The applications were performed by a different operator (CAS) from the one who measured the study parameters. During irradiation, the tip of the laser probe was placed perpendicularly with slight contact on the area. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was repeated by six more applications performed every other day, with a total of 7 laser applications.~Low Level Laser Therapy: Low Level Laser Therapy on the palatal donor site of connective tissue graft.~GaAlAs laser: Utilization of GaAlAs laser to irradiation on the palatal donor site."
629025|NCT02578992|B3|Baseline|Total|Total of all reporting groups
629026|NCT02578992|B2|Baseline|Neutral Position|The patients’ head was placed in the neutral position and then the patient was intubated with Trachway by single-handed chin lift technique
629027|NCT02578992|B1|Baseline|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position) and then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
629028|NCT02578992|P2|Participant Flow|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
629029|NCT02578992|P1|Participant Flow|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
629030|NCT02578992|O2|Outcome|Head-lift Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
629031|NCT02578992|O1|Outcome|Neutral Head Position|All patients were asked to rate the degree of sore throat, using a visual analogue scale after anesthesia emergence in the post-anesthesia care unit
629032|NCT02578992|O2|Outcome|Head-lift Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
629033|NCT02578992|O1|Outcome|Neutral Head Position|Hemodynamic variables were recorded 3 min before, and 1, 3, and 5 min after intubation.
629136|NCT02576639|O5|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629856|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629036|NCT02578992|O2|Outcome|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
629037|NCT02578992|O1|Outcome|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
629038|NCT02578992|E2|Reported Event|Neutral Position|The patients’ head was placed in the neutral position.An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique
629039|NCT02578992|E1|Reported Event|Head-lift Position|"The patients’ head was placed in the head-lift position(A 7 cm high pillow was set beneath the patients’ head with head in neutral position). An assistant anesthesiologist standing beside the patient and opposite to the left of the head anesthesiologist performed the manual in-line stabilization to simulate the scenario of intubation in patients with cervical spine injury. Then the patient was intubated with Trachway by single-handed chin lift technique~Head-lift position: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation.~7cm high pillow: A 7 cm high pillow was set beneath the patients’ head with head in neutral position for intubation."
629040|NCT02578186|B1|Baseline|Entire Study Population|Entire Study Population Includes groups that received Placebo and Drug First
629041|NCT02578186|P2|Participant Flow|Placebo, Then Diphenhydramine Hydrochloride|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: Placebo once a day at bedtime in first intervention period and DPH (50 mg) once a day at bedtime for the second intervention period (after 5 day washout period)."
629042|NCT02578186|P1|Participant Flow|Diphenhydramine Hydrochloride, Then Placebo|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: DPH (50 mg) once a day at bedtime in first intervention period and Placebo once a day at bedtime for the second intervention period (after 5 day washout period)."
629043|NCT02578186|O2|Outcome|Placebo|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: 30 mL at bedtime"
629044|NCT02578186|O1|Outcome|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: 30 mL at bedtime"
629045|NCT02578186|E2|Reported Event|Placebo|"Placebo elixir taken when subjects had trouble falling asleep~Placebo: 30 mL at bedtime"
629046|NCT02578186|E1|Reported Event|Diphenhydramine Hydrochloride|"Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep~Diphenhydramine Hydrochloride: 30 mL at bedtime"
629047|NCT02577445|B3|Baseline|Total|Total of all reporting groups
629048|NCT02577445|B2|Baseline|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
629049|NCT02577445|B1|Baseline|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
629050|NCT02577445|P2|Participant Flow|CSA Patients With remedē System|"For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.~Patients will be asked to complete quality of life questionnaires at baseline and during follow-up visits.~Patients will be evaluated at the time of therapy activation which may be followed by one or more titration visits. Patient follow-ups will be programmed at 6 and 12 months, and yearly, up to 5 years post-implant, until the last patients reach their 2-year follow-up.~Echocardiogram for patients with reduced ejection fraction (≤ 45%) and follow-up respiratory polygraphy are considered standard of care, however, to ensure sufficient data, related to the study objectives, are being collected, baseline and 12-months echocardiogram for a subgroup of patients and respiratory polygraphy at 12-month follow-up for all patients must be done when participating in this study:"
629051|NCT02577445|P1|Participant Flow|CSA Patients NOT Implanted With remedē System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
629052|NCT02577445|O2|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
629053|NCT02577445|O1|Outcome|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
629054|NCT02577445|O1|Outcome|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
629055|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
629056|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
629857|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629057|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
629058|NCT02577445|O1|Outcome|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
629059|NCT02577445|E2|Reported Event|CSA Patients With remedē System|For all patients diagnosed with CSA and referred for implant / or have already been implanted with remedē system, information from the implant procedure will be collected.
629060|NCT02577445|E1|Reported Event|CSA Patients NOT Implanted With remedē® System|For all patients diagnosed with CSA who will not move forward with remedē® system therapy, the intention is to obtain information on their alternate therapy, if any, and safety information, including all cause mortality and all cause hospitalizations during phone calls at 6, 12 and 24 months after enrollment.
629061|NCT02577315|B3|Baseline|Total|Total of all reporting groups
629062|NCT02577315|B2|Baseline|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
629063|NCT02577315|B1|Baseline|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
629064|NCT02577315|P2|Participant Flow|Empagliflozin + Metformin / Fixed Dose Combination (FDC)|Participants first received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose, then they received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
629065|NCT02577315|P1|Participant Flow|Fixed Dose Combination (FDC) / Empagliflozin + Metformin|Participants first received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC), then they received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal. Single dose in each treatment period was separated by a washout phase of at least 5 days between drug administrations.
629066|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629067|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629068|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629069|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629070|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629071|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629072|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629073|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629074|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629075|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629076|NCT02577315|O2|Outcome|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629077|NCT02577315|O1|Outcome|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629078|NCT02577315|E2|Reported Event|Empagliflozin + Metformin Free Combination|Participants received free combination of 1 film-coated tablet of 25 mg Empagliflozin and 1 film-coated tablet of 1000 mg Metformin (brand name: Glucophage) as a single dose. The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629079|NCT02577315|E1|Reported Event|Empagliflozin / Metformin (FDC)|Participants received 2 film-coated tablets of 12.5 milligram (mg) Empagliflozin and 500 mg Metformin as a single dose in a fixed dose combination (FDC). The study medication was administered orally in the morning with 200 mL of water after intake of a high-fat, high-caloric meal.
629080|NCT02576639|B6|Baseline|Total|Total of all reporting groups
629081|NCT02576639|B5|Baseline|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629082|NCT02576639|B4|Baseline|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629083|NCT02576639|B3|Baseline|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629084|NCT02576639|B2|Baseline|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629085|NCT02576639|B1|Baseline|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
629086|NCT02576639|P5|Participant Flow|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629087|NCT02576639|P4|Participant Flow|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629088|NCT02576639|P3|Participant Flow|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629089|NCT02576639|P2|Participant Flow|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629090|NCT02576639|P1|Participant Flow|Placebo|Matching placebo to CNP520 was taken once daily (qd) orally for 13 weeks.
629091|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629092|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629093|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629094|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629095|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629096|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629097|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629098|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629099|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629100|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629101|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629102|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629103|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629104|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629105|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629106|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629107|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629108|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629109|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629110|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629111|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629112|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629113|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629114|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629115|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629116|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629117|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629118|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629119|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629120|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629121|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629122|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629123|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629124|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629125|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629126|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629127|NCT02576639|O4|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629128|NCT02576639|O3|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629129|NCT02576639|O2|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629130|NCT02576639|O1|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629131|NCT02576639|O5|Outcome|CNP520 85 mg|CNP520 85 mg was taken qd orally for 13 weeks.
629132|NCT02576639|O4|Outcome|CNP520 35 mg|CNP520 35 mg was taken qd orally for 13 weeks.
629133|NCT02576639|O3|Outcome|CNP520 10 mg|CNP520 10 mg was taken qd orally for 13 weeks.
629134|NCT02576639|O2|Outcome|CNP520 2 mg|CNP520 2 mg was taken qd orally for 13 weeks.
629858|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629146|NCT02576535|B1|Baseline|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629147|NCT02576535|P1|Participant Flow|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629148|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629149|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629150|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629151|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629152|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629153|NCT02576535|O1|Outcome|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629154|NCT02576535|E1|Reported Event|Fractionated Stereotactic Radiosurgery|"The radiation dose will be delivered by the standard, FDA approved Leksell gamma unit (Gamma knife; Elekta Instruments, Atlanta, GA). Treatment dose and volume will be determined using the Gamma Plan software provided with the unit (Elekta Instruments, Atlanta, GA).~Fractionated stereotactic radiosurgery~Leskell gamma unit: FDA approved device"
629155|NCT02576145|B3|Baseline|Total|Total of all reporting groups
629156|NCT02576145|B2|Baseline|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629157|NCT02576145|B1|Baseline|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629158|NCT02576145|P2|Participant Flow|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629159|NCT02576145|P1|Participant Flow|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629160|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629161|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629162|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629163|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629164|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629638|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
629165|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629166|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629167|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629168|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629169|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629170|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629171|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629172|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629173|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629174|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629175|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629176|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629177|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629178|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629179|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629180|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629181|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629182|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629209|NCT02575911|O1|Outcome|LenSx - Month 1 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
629210|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
629183|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629184|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629185|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629186|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629187|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629188|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629189|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629190|NCT02576145|O2|Outcome|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629191|NCT02576145|O1|Outcome|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629192|NCT02576145|E2|Reported Event|Group B (Post Daclizumab Therapy)|Participants who had a renal transplant and who were within 4 to 18 months of completing daclizumab therapy were included. Participants were vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine on Day 1 and Day 29.
629193|NCT02576145|E1|Reported Event|Group A (With Daclizumab Therapy)|Participants who had a renal transplant prior to 6 weeks of study vaccine administration and who were receiving daclizumab therapy were included. Participants were initially vaccinated with Diphtheria Tetanus Toxoid (DT) vaccine and Keyhole Limpet Hemocyanin (KLH) vaccine at least 30 minutes prior to fifth-dose of daclizumab infusion (i.e. Day 1). The next vaccination with DT and KLH was done on Day 29.
629194|NCT02576041|B1|Baseline|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
629195|NCT02576041|P1|Participant Flow|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
629196|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
629197|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
629198|NCT02576041|O1|Outcome|Bilastine|Patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3) day treatment period with Bilastine
629199|NCT02576041|E1|Reported Event|Placebo (run-in); Bilastine|"At V0, the enrolled patient received the complete drug-kit and started a 7 (+3)-day wash-out period with placebo. At the end of the 7 (+3)-days of placebo-treatment period, patients repeated the F1-high speed simulator test at Visit V1, and afterwards initiated the 7 (+3)-day treatment period with active treatment (bilastine).~Bilastine: Bilastine tablets once a day for 7+3 days~Placebo: Placebo tablets once a day during 7+3 days run in period"
629200|NCT02575911|B1|Baseline|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
629201|NCT02575911|P1|Participant Flow|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
629202|NCT02575911|O2|Outcome|LenSx - 3 Months Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
629203|NCT02575911|O1|Outcome|LenSx - 1 Month Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 1 month post-operative
629204|NCT02575911|O1|Outcome|LenSx|LASIK surgery in both eyes using LenSx® Femtosecond Laser System
629205|NCT02575911|O3|Outcome|LenSx - Month 3 Postoperative|LASIK surgery in both eyes using LenSx® Femtosecond Laser System, 3 months post-operative
629639|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
629217|NCT02575911|E1|Reported Event|Pre-treatment|All who consented to participate in the study prior to the initiation of study treatment
629218|NCT02574845|B7|Baseline|Total|Total of all reporting groups
629219|NCT02574845|B6|Baseline|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629220|NCT02574845|B5|Baseline|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629221|NCT02574845|B4|Baseline|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629222|NCT02574845|B3|Baseline|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629223|NCT02574845|B2|Baseline|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629224|NCT02574845|B1|Baseline|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629225|NCT02574845|P6|Participant Flow|REF-T1-T2-T3-T4-T5|The subjects received REF alone, followed by T1, followed by T2, followed by T3, followed by T4 and followed by T5. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629226|NCT02574845|P5|Participant Flow|T5-T4-T3-T2-T1-REF|The subjects received T5, followed by T4, followed by T3, followed by T2, followed by T1 and followed by REF alone. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629227|NCT02574845|P4|Participant Flow|T4-T2-T5-REF-T3-T1|The subjects received T4, followed by T2, followed by T5, followed by REF alone, followed by T3 and followed by T1. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629228|NCT02574845|P3|Participant Flow|T3-T5-T1-T4-REF-T2|The subjects received T3, followed by T5, followed by T1, followed by T4, followed by REF alone and followed by T2. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629229|NCT02574845|P2|Participant Flow|T2-REF-T4-T1-T5-T3|The subjects received T2, followed by REF alone, followed by T4, followed by T1, followed by T5 and followed by T3. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629230|NCT02574845|P1|Participant Flow|Treatment (T) 1-T3-Reference (REF)-T5-T2-T4|The subjects received test treatment 1 (T1) which is 10 milligram (mg) metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor) followed by test treatment 3 (T3) which is 500mg metformin hydrochloride together with REF followed by REF alone followed by test treatment 5 (T5) which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with REF followed by test treatment 2 (T2) which is 50 mg of metformin hydrochloride together with REF followed by test treatment 4 (T4) which is 1mg of furosemide together with REF. Trial medication was administered as a single oral dose in the fasted state in each treatment period. The six single dose treatment periods were separated from each other by a wash-out period of at least 6 days between the drug administrations.
629231|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629232|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629233|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629279|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
629234|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629235|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629236|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629237|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629238|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629239|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629240|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629241|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629242|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629243|NCT02574845|O6|Outcome|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629244|NCT02574845|O5|Outcome|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629245|NCT02574845|O4|Outcome|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629246|NCT02574845|O3|Outcome|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629247|NCT02574845|O2|Outcome|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629248|NCT02574845|O1|Outcome|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629249|NCT02574845|E6|Reported Event|Treatment 5|The subjects received test treatment 5 which is 5 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629250|NCT02574845|E5|Reported Event|Treatment 4|The subjects received test treatment 4 which is 1 mg furosemide (oral solution, brand name: Lasix liquidum) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629251|NCT02574845|E4|Reported Event|Treatment 3|The subjects received test treatment 3 which is 500 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629252|NCT02574845|E3|Reported Event|Treatment 2|The subjects received test treatment 2 which is 50 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629253|NCT02574845|E2|Reported Event|Treatment 1|The subjects received test treatment 1 which is 10 mg metformin hydrochloride (oral solution, brand name: MetfoLiquid GeriaSan) together with the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629254|NCT02574845|E1|Reported Event|REF Alone|The subjects received the reference treatment (REF) which is rosuvastatin (film-coated, brand name: Crestor). Trial medication was administered as a single oral dose in the fasted state.
629255|NCT02574260|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
629256|NCT02574260|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ plaque forming units (PFU)/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
629257|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
629258|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
629259|NCT02574260|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
629260|NCT02574260|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec 10⁸ PFU/mL (up to 4 mL depending on tumor size) administered intratumorally every 2 weeks, on Day 1 and Day 15 of 28-day cycles until discontinuation criteria were met.
629261|NCT02573870|B3|Baseline|Total|Total of all reporting groups
629262|NCT02573870|B2|Baseline|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
629263|NCT02573870|B1|Baseline|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
629264|NCT02573870|P2|Participant Flow|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed,while receiving investigational product.
629265|NCT02573870|P1|Participant Flow|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
629266|NCT02573870|O2|Outcome|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
629267|NCT02573870|O1|Outcome|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
629268|NCT02573870|E2|Reported Event|BAT/FF 300/100 µg|Participants received oral inhalation of BAT/FF 300/100 µg via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
629269|NCT02573870|E1|Reported Event|Placebo|Participants received oral inhalation of placebo via a dry powder inhaler once daily in the morning for 6 weeks. Participants also received albuterol as a rescue medication throughout the study as needed, while receiving investigational product.
629270|NCT02572752|B4|Baseline|Total|Total of all reporting groups
629271|NCT02572752|B3|Baseline|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
629272|NCT02572752|B2|Baseline|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
629273|NCT02572752|B1|Baseline|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
629274|NCT02572752|P3|Participant Flow|Nin 1x200 mg(T) / Nin 2x100 mg(R1) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water, followed in Period 2 (Reference treatment (R1)) and Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
629275|NCT02572752|P2|Participant Flow|Nin 2x100 mg(R1) / Nin 1x200 mg(T) / Nin 2x100 mg(R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water, followed in Period 2 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water and in Period 3 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
629276|NCT02572752|P1|Participant Flow|Nin 2x100 mg(R1) / Nin 2x100 mg(R2) / Nin 1x200 mg(T)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) and Period 2 (Reference treatment (R2)) with nintedanib (nin) soft gelatine capsule, 200 mg (2x100 mg) with about 240 mL of water, followed in Period 3 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water. Treatment periods were separated by a wash-out phase of at least 12 days.
629277|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
629278|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
629815|NCT02555722|O1|Outcome|Week 1|fanfilcon A lens (test)
629280|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
629281|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
629282|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
629283|NCT02572752|O3|Outcome|Nintedanib, Reference Treatment (R2)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R2)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
629284|NCT02572752|O2|Outcome|Nintedanib, Reference Treatment (R1)|Subjects were treated with single oral dose, started in Period 1 (Reference treatment (R1)) with nintedanib soft gelatine capsule, 200 mg (2x100mg) with about 240 mL of water.
629285|NCT02572752|O1|Outcome|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose, started in Period 1 (Test treatment (T)) with nintedanib soft gelatine capsule, 200 mg (1x200mg) with about 240 mL of water.
629286|NCT02572752|E2|Reported Event|Nintedanib, Reference Treatment (R1 & R2)|Subjects were treated twice with single oral dose of nintedanib soft gelatine capsule (Reference treatment (R1 & R2)), 200 mg (2x100mg) with about 240 mL of water.
629287|NCT02572752|E1|Reported Event|Nintedanib, Test Treatment (T)|Subjects were treated with single oral dose of nintedanib soft gelatine capsule (Test treatment (T)) , 200 mg (1x200mg) with about 240 mL of water.
629288|NCT02572609|B3|Baseline|Total|Total of all reporting groups
629289|NCT02572609|B2|Baseline|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
629290|NCT02572609|B1|Baseline|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
629291|NCT02572609|P2|Participant Flow|Sequence: RT|"2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 1 and 01 pastille, single dose, of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 2.~Washout period: 7 days"
629292|NCT02572609|P1|Participant Flow|Sequence: TR|"01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product) in period 1 and 2.5 mL, single dose, of Mucosolvan ® adult syrup (Reference product) in period 2.~Washout period: 7 days"
629293|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
629294|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
629295|NCT02572609|O2|Outcome|Ambroxol Hydrochloride Soft Pastille|01 pastille, single dose of Ambroxol hydrochloride soft pastille 15 mg (Test product).
629296|NCT02572609|O1|Outcome|Mucosolvan ® Adult Syrup|2.5 mL, single dose, of Mucosolvan ® adult syrup 6 mg/mL (Reference product).
629297|NCT02572609|E2|Reported Event|Ambroxol Hydrochloride Soft Pastille|
629298|NCT02572609|E1|Reported Event|Mucosolvan® Adult Syrup|
629299|NCT02572427|B3|Baseline|Total|Total of all reporting groups
629300|NCT02572427|B2|Baseline|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
629301|NCT02572427|B1|Baseline|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
629302|NCT02572427|P2|Participant Flow|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
629303|NCT02572427|P1|Participant Flow|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
629304|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
629305|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
629306|NCT02572427|O2|Outcome|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
629342|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629816|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629307|NCT02572427|O1|Outcome|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
629308|NCT02572427|E2|Reported Event|No Added Education for Intubation Skills|"Interventions: Training for Routine Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP) training; no additional training for intubating newborns.~No added education for intubation skills: Routine training in neonatal resuscitation but no added experience in simulation lab."
629309|NCT02572427|E1|Reported Event|Education for Intubation Skills|"Interventions: Training for Pediatric Advanced Life Support (PALS) and Neonatal Resuscitation Program (NRP); 7 minute excerpt from the NRP training video regarding intubation; cognitive instruction which consisted of equipment needed for intubation; hands on instruction using the Storz video laryngoscope with manikins in simulation lab.~Education for intubation skills: Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab."
629310|NCT02571634|B1|Baseline|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
629311|NCT02571634|P1|Participant Flow|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
629312|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control."
629313|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
629314|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
629315|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
629316|NCT02571634|O1|Outcome|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
629317|NCT02571634|E1|Reported Event|Open Label|"Open label, no blinding, everyone receives Lazanda.~Lazanda: Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.~There were no adverse events."
629318|NCT02571153|B4|Baseline|Total|Total of all reporting groups
629319|NCT02571153|B3|Baseline|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629320|NCT02571153|B2|Baseline|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629321|NCT02571153|B1|Baseline|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629322|NCT02571153|P3|Participant Flow|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629323|NCT02571153|P2|Participant Flow|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629324|NCT02571153|P1|Participant Flow|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629325|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629326|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629327|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629328|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629329|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629330|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629331|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629332|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629333|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629334|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629335|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629336|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629337|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629338|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629339|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629340|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629341|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629817|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629343|NCT02571153|O3|Outcome|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629344|NCT02571153|O2|Outcome|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629345|NCT02571153|O1|Outcome|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629346|NCT02571153|E3|Reported Event|Ketamine 0.4|"ketamine 0.4 mg/kg (5 mL)~Ketamine 0.4 mg/kg: Intravenous ketamine 0.4 mg/kg after induction of anesthesia"
629347|NCT02571153|E2|Reported Event|Ketamine 0.2|"ketamine 0.2 mg/kg (5 mL)~Ketamine 0.2 mg/kg: Intravenous ketamine 0.2 mg/kg after induction of anesthesia"
629348|NCT02571153|E1|Reported Event|Saline Group|"Normal saline 0.9% (5 mL)~Normal saline: Intravenous normal saline 0.9% 5 mL"
629349|NCT02570425|B3|Baseline|Total|Total of all reporting groups
629350|NCT02570425|B2|Baseline|Budesonide/Formoterol (BF) Spiromax® First, Then Turbohaler®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629351|NCT02570425|B1|Baseline|SYMBICORT Turbohaler® First, Then Spiromax®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629352|NCT02570425|P2|Participant Flow|Placebo Comparator: Turbohaler Followed by Spiromax|Training on SYMBICORT Turbohaler followed by BF Spiromax
629353|NCT02570425|P1|Participant Flow|Placebo Comparator: Spiromax Followed by Turbohaler|Training on BF Spiromax followed by SYMBICORT Turbohaler
629354|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629355|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629356|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629357|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629409|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629818|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629358|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629359|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629360|NCT02570425|O3|Outcome|No Preference|"HCPs indicated no preference of device during training with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device or placebo comparator: SYMBICORT® Turbohaler using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629361|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629362|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629363|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629364|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629365|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629410|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629444|NCT02570165|O2|Outcome|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629366|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629367|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629368|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629369|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629370|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629371|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629372|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629411|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629412|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629413|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629373|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629374|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629375|NCT02570425|O2|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629376|NCT02570425|O1|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Training HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training."
629377|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629378|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629379|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629414|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629415|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629416|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629819|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629380|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629381|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629382|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629383|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629384|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629385|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629386|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629417|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629820|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629387|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629388|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629389|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629390|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629391|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629392|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629393|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629418|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629445|NCT02570165|O1|Outcome|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
629821|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629394|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629395|NCT02570425|O2|Outcome|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629396|NCT02570425|O1|Outcome|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629397|NCT02570425|E2|Reported Event|Budesonide/Formoterol (BF) Spiromax®|"Traing HCPs with a placebo comparator: Budesonide/Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device"
629398|NCT02570425|E1|Reported Event|SYMBICORT Turbohaler®|"Training HCPs with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: Budesonide/Formoterol (BF) Spiromax®: Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Placebo Comparator: SYMBICORT® Turbohaler: Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.~Training HCPs: Training HCPS with both devices using a 6-level system to examine the number of levels required to acquire mastery of device at baseline"
629399|NCT02570295|B3|Baseline|Total|Total of all reporting groups
629400|NCT02570295|B2|Baseline|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629401|NCT02570295|B1|Baseline|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629402|NCT02570295|P2|Participant Flow|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629403|NCT02570295|P1|Participant Flow|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629404|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629405|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629406|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629407|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629408|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629473|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629419|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629420|NCT02570295|O2|Outcome|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629421|NCT02570295|O1|Outcome|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629422|NCT02570295|E2|Reported Event|Traditional Sport Concept|Sport according to the traditional sport concept of the Swiss Armed Forces
629423|NCT02570295|E1|Reported Event|Swiss Army Physical Fitness Training|"Sport according to the new sport concept (Swiss Army Physical Fitness Training) of the Swiss Armed Forces~Swiss Army Physical Fitness Training: 2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training"
629424|NCT02570165|B8|Baseline|Total|Total of all reporting groups
629425|NCT02570165|B7|Baseline|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
629426|NCT02570165|B6|Baseline|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629427|NCT02570165|B5|Baseline|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629428|NCT02570165|B4|Baseline|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629429|NCT02570165|B3|Baseline|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629430|NCT02570165|B2|Baseline|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629431|NCT02570165|B1|Baseline|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
629432|NCT02570165|P7|Participant Flow|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
629433|NCT02570165|P6|Participant Flow|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629434|NCT02570165|P5|Participant Flow|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629435|NCT02570165|P4|Participant Flow|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629436|NCT02570165|P3|Participant Flow|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629437|NCT02570165|P2|Participant Flow|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629438|NCT02570165|P1|Participant Flow|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
629439|NCT02570165|O7|Outcome|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
629440|NCT02570165|O6|Outcome|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629441|NCT02570165|O5|Outcome|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629442|NCT02570165|O4|Outcome|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629443|NCT02570165|O3|Outcome|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629474|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629446|NCT02570165|O7|Outcome|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
629447|NCT02570165|O6|Outcome|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629448|NCT02570165|O5|Outcome|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629449|NCT02570165|O4|Outcome|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629450|NCT02570165|O3|Outcome|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629451|NCT02570165|O2|Outcome|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629452|NCT02570165|O1|Outcome|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
629453|NCT02570165|E7|Reported Event|UMEC/VI 62.5/25 µg|Participants received 1 actuation of UMEC/VI 62.5/25 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained UMEC blended with lactose and magnesium stearate. Second strip contained VI blended with lactose and magnesium stearate.
629454|NCT02570165|E6|Reported Event|Batefenterol 600 µg|Participants received 1 actuation of batefenterol 600 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629455|NCT02570165|E5|Reported Event|Batefenterol 300 µg|Participants received 1 actuation of batefenterol 300 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629456|NCT02570165|E4|Reported Event|Batefenterol 150 µg|Participants received 1 actuation of batefenterol 150 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629457|NCT02570165|E3|Reported Event|Batefenterol 75 µg|Participants received 1 actuation of batefenterol 75 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained btefenterol blended with lactose.
629458|NCT02570165|E2|Reported Event|Batefenterol 37.5 µg|Participants received 1 actuation of batefenterol 37.5 µg inhalation powder administered via DPI (containing 2 strips) once daily in the morning for 42 days. First strip contained lactose and second strip contained batefenterol blended with lactose.
629459|NCT02570165|E1|Reported Event|Placebo|Participants received 1 actuation of placebo inhalation powder via Dry Powder Inhaler (DPI) (containing 2 strips) once daily in the morning for 42 days.
629460|NCT02570022|B3|Baseline|Total|Total of all reporting groups
629461|NCT02570022|B2|Baseline|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
629462|NCT02570022|B1|Baseline|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
629463|NCT02570022|P2|Participant Flow|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
629464|NCT02570022|P1|Participant Flow|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
629465|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
629466|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
629467|NCT02570022|O2|Outcome|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
629468|NCT02570022|O1|Outcome|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
629469|NCT02570022|E2|Reported Event|Inter-scalene Nerve Block|"Patients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.~Inter-scalene nerve block: Pre-operative inter-scalene nerve block~Ropivacaine: Ropivicaine was used for the inter-scalene nerve block."
629470|NCT02570022|E1|Reported Event|Liposomal Bupivacaine|"Patients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.~Liposomal bupivacaine: Local infiltration of liposomal bupivacaine"
629471|NCT02569996|B1|Baseline|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629472|NCT02569996|P1|Participant Flow|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629475|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629476|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629477|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629478|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629479|NCT02569996|O1|Outcome|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629480|NCT02569996|E1|Reported Event|Rituximab|Participants received rituximab 375 milligrams per meter square (mg/m^2) every 8 weeks for 24 months
629481|NCT02569658|B3|Baseline|Total|Total of all reporting groups
629482|NCT02569658|B2|Baseline|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629483|NCT02569658|B1|Baseline|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629484|NCT02569658|P2|Participant Flow|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629485|NCT02569658|P1|Participant Flow|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629486|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629487|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629488|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629489|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629490|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629491|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629492|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629493|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629494|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629495|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629496|NCT02569658|O2|Outcome|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629497|NCT02569658|O1|Outcome|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629498|NCT02569658|E2|Reported Event|Placebo Group|"Group will be administered 10 ml normal saline placebo IV bolus 10 minutes prior to incision~Placebo"
629499|NCT02569658|E1|Reported Event|Tranexamic Acid Group|"Group will be administered 1 gram tranexamic acid IV bolus (10 ml solution) 10 minutes prior to incision.~Tranexamic Acid"
629500|NCT02568852|B3|Baseline|Total|Total of all reporting groups
629501|NCT02568852|B2|Baseline|Group 2|Laparoscopic cholecystectomy in under 14 mmHg pneumoperitoneum
629502|NCT02568852|B1|Baseline|Group 1|Laparoscopic cholecystectomy in under 10 mmHg pneumoperitoneum
629503|NCT02568852|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy under combined anaesthesia (Spino epidural).
629504|NCT02568852|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy under general anaesthesia
629505|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629506|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629507|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629508|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629509|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629510|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629511|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629512|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629513|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629514|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629515|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629516|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629822|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629517|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629518|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629519|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629520|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629521|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629522|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629523|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629524|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629525|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629526|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629527|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629528|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629529|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629530|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629531|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629532|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629533|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629534|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629535|NCT02568852|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anaesthesia (Spino epidural).~General anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under general anesthesia"
629536|NCT02568852|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in general anaesthesia~Combined anaesthesia: 10 mmHg pressure, laparoscopic cholecystectomy under combined spinal epidural anaesthesia"
629537|NCT02568852|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in under spinal epidural anaesthesia.(10 mmHg CO2 pneumoperitoneum)
629538|NCT02568852|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in under general anaesthesia.(10 mmHg CO2 pneumoperitoneum)
629539|NCT02567188|B1|Baseline|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629540|NCT02567188|P1|Participant Flow|Chronic Kidney Disease (CKD) Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629541|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629542|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629543|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629544|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629545|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629546|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629547|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629548|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629592|NCT02563093|B4|Baseline|Fluzone High-Dose Vaccine|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629549|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629550|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629551|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629552|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629553|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629554|NCT02567188|O1|Outcome|Cohort of CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629555|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629556|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629557|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629558|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629559|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629560|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629561|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629562|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629563|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629564|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629565|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629566|NCT02567188|O1|Outcome|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629567|NCT02567188|E1|Reported Event|CKD Participants|Pre-dialysis participants with CKD treated with MIRCERA according to the current standard of care and in line with the current local summary of product characteristics were observed for maximum of 12 months.
629568|NCT02568345|B1|Baseline|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
629569|NCT02568345|P1|Participant Flow|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
629570|NCT02568345|O1|Outcome|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
629590|NCT02563834|E1|Reported Event|Saline|"Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
629591|NCT02563093|B5|Baseline|Total|Total of all reporting groups
629823|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629571|NCT02568345|E1|Reported Event|Sugammadex ED90|"Sequential design method up-and-down of the biased coin aimed to determine the minimum effective dose in 90% of patients (ED90).~The following doses were chosen: 2.0 mg/kg, 2.2 mg/kg, 2.4 mg/kg, 2.6 mg/kg, 2.8 mg/kg.~sugammadex ED90: The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
629572|NCT02563834|B3|Baseline|Total|Total of all reporting groups
629573|NCT02563834|B2|Baseline|Type 2 Diabetes|Participants with Type 2 diabetes treated with any combination of oral agents and insulin except PPARgamma agonists.
629574|NCT02563834|B1|Baseline|Lean Controls|Lean non-diabetic control participants, taking no regular medications.
629575|NCT02563834|P2|Participant Flow|Type 2 DM|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
629576|NCT02563834|P1|Participant Flow|Lean Control|"Studies will be performed on 2 separate days under fasting conditions, using a saline infusion on Day 1 and insulin infusion on Day 2. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate) on both study days.~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
629577|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
629578|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
629579|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
629580|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
629581|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
629582|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
629583|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
629584|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
629585|NCT02563834|O4|Outcome|Type 2 DM - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
629586|NCT02563834|O3|Outcome|Type 2 DM - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms"
629587|NCT02563834|O2|Outcome|Lean Control - Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
629588|NCT02563834|O1|Outcome|Lean Control - Saline|"Studies will be performed on a separate day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Saline: Saline infusion for control"
629589|NCT02563834|E2|Reported Event|Insulin Clamp|"Studies will be performed on a separate day under fasting conditions, using an insulin infusion to achieve steady state insulin/glucose clamp conditions. Studies will be performed on one day under fasting conditions, using a saline infusion. All subjects will receive infusions of radiolabeled acetate and radiolabeled thiapalmitate tracer (16-18-F-fluoro-4-thiapalmitate).~thiapalmitate tracer: Radiolabeled tracer infusion; occurs in all treatment arms~Insulin: Insulin infusion for insulin/glucose clamp procedure"
629824|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629593|NCT02563093|B3|Baseline|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629594|NCT02563093|B2|Baseline|Fluzone Quadrivalent Intradermal Vaccine|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629595|NCT02563093|B1|Baseline|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629596|NCT02563093|P4|Participant Flow|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629597|NCT02563093|P3|Participant Flow|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629598|NCT02563093|P2|Participant Flow|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629599|NCT02563093|P1|Participant Flow|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629600|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629601|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629602|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629603|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629604|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629605|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629606|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629607|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629608|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629609|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629610|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629611|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629612|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629613|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629614|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an Intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629615|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629616|NCT02563093|O4|Outcome|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629617|NCT02563093|O3|Outcome|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629618|NCT02563093|O2|Outcome|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629619|NCT02563093|O1|Outcome|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629620|NCT02563093|E4|Reported Event|Fluzone High-Dose Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone High-Dose vaccine
629621|NCT02563093|E3|Reported Event|Fluzone Quadrivalent Vaccine (≥ 65 Years)|Adults ≥ 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629622|NCT02563093|E2|Reported Event|Fluzone Quadrivalent Intradermal Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intradermal injection of a dose of Fluzone Intradermal Quadrivalent vaccine
629623|NCT02563093|E1|Reported Event|Fluzone Quadrivalent Vaccine (18 to < 65 Years)|Adults 18 to < 65 years of age who received an intramuscular injection of a dose of Fluzone Quadrivalent vaccine
629624|NCT02561572|B3|Baseline|Total|Total of all reporting groups
629625|NCT02561572|B2|Baseline|Control|No intervention for 30 minutes.
629626|NCT02561572|B1|Baseline|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
629627|NCT02561572|P2|Participant Flow|Control|No intervention for 30 minutes.
629628|NCT02561572|P1|Participant Flow|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
629629|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
629630|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
629631|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
629632|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
629633|NCT02561572|O2|Outcome|Control|No intervention for 30 minutes.
629640|NCT02561572|O1|Outcome|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
629641|NCT02561572|E2|Reported Event|Control|No intervention for 30 minutes.
629642|NCT02561572|E1|Reported Event|Intervention|"Acupuncture at the Yintang point for 30 minutes.~Acupuncture: Yintang point acupuncture"
629643|NCT02557698|B3|Baseline|Total|Total of all reporting groups
629644|NCT02557698|B2|Baseline|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629645|NCT02557698|B1|Baseline|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629646|NCT02557698|P2|Participant Flow|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629647|NCT02557698|P1|Participant Flow|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629648|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629649|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629650|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629651|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629652|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629653|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629654|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629655|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629656|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629657|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629658|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629659|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629660|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629661|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629662|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629663|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629664|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629665|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629666|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629667|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629668|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629669|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629670|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629671|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629672|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629673|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629674|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629675|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629676|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629677|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629678|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629679|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629680|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629681|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629682|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629683|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629684|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629685|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629686|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629687|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629688|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629689|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629690|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629691|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629692|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629693|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629694|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629695|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629696|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629697|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629698|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629699|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629700|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629701|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629702|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629703|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629704|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629705|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629706|NCT02557698|O2|Outcome|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629707|NCT02557698|O1|Outcome|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629708|NCT02557698|E2|Reported Event|Standard Skin Cleanser|Usual skin cleanser (non-oil containing), bathing or showering every other day for four weeks
629709|NCT02557698|E1|Reported Event|Balneum Oil Bath|"Balneum oil bath, bathing every other day for four weeks~Balneum oil bath"
629710|NCT02557646|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629711|NCT02557646|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a (Pegasys) and ribavirin (Copegus) in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629712|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629713|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629714|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629715|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629716|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629717|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629718|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629719|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629720|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629721|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629722|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629723|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629724|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629725|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629726|NCT02557646|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629727|NCT02557646|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Treatment naive participants with confirmed chronic hepatitis C who started combination therapy with peginterferon alfa 2a and ribavirin in accordance with current guidelines and summary of product characteristics, upon decision of the treating physician, considering each participant’s individual response, received combination therapy for 24, 48 or 72 weeks, followed by a 24-week follow-up period.
629728|NCT02555228|B3|Baseline|Total|Total of all reporting groups
629729|NCT02555228|B2|Baseline|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy."
629730|NCT02555228|B1|Baseline|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy."
629731|NCT02555228|P2|Participant Flow|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629732|NCT02555228|P1|Participant Flow|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629733|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629734|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629735|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629736|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629737|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629738|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629739|NCT02555228|O2|Outcome|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629740|NCT02555228|O1|Outcome|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629741|NCT02555228|E2|Reported Event|Placebo|"Just 5 mls of water~Water: 5mls of water is given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629742|NCT02555228|E1|Reported Event|Simethicone Premedication|"Liquid simethicone (1ml volume) in 5mls of water~Simethicone: 100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.~27 patients randomized to this group."
629743|NCT02556307|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629744|NCT02556307|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
629745|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629746|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629747|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629748|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629749|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629750|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629751|NCT02556307|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629752|NCT02556307|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received peginterferon alfa-2a and ribavirin according to the standard practice in line with current SPCs/local labeling.
629753|NCT02555722|B3|Baseline|Total|Total of all reporting groups
629754|NCT02555722|B2|Baseline|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
629755|NCT02555722|B1|Baseline|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
629756|NCT02555722|P2|Participant Flow|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
629757|NCT02555722|P1|Participant Flow|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
629758|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629759|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629760|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629761|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629762|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629763|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629764|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629765|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629766|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629767|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629768|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629769|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629770|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629771|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629772|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629773|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629774|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629775|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629776|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629777|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629778|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629779|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629780|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629781|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629782|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629783|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629784|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629785|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629786|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629787|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629788|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629789|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629790|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629791|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629792|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629793|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629794|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629795|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629796|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629797|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629798|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629799|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629800|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629801|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629802|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629803|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629804|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629805|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629806|NCT02555722|O5|Outcome|Month 3|enfilcon A lens (control)
629807|NCT02555722|O4|Outcome|Month 2|enfilcon A lens (control)
629808|NCT02555722|O3|Outcome|Month 1|enfilcon A lens (control)
629809|NCT02555722|O2|Outcome|Week 2|enfilcon A lens (control)
629810|NCT02555722|O1|Outcome|Week 1|enfilcon A lens (control)
629811|NCT02555722|O5|Outcome|Month 3|fanfilcon A lens (test)
629812|NCT02555722|O4|Outcome|Month 2|fanfilcon A lens (test)
629813|NCT02555722|O3|Outcome|Month 1|fanfilcon A lens (test)
629814|NCT02555722|O2|Outcome|Week 2|fanfilcon A lens (test)
629859|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629860|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629861|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629862|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629863|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629864|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629865|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629866|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629867|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629868|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629869|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629870|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629871|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629872|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629873|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629874|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629875|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629876|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629877|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629878|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629879|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629880|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629881|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629882|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629883|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629884|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629885|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629886|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629887|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629888|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629889|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629890|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629891|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629892|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629893|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629894|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629895|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629896|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629897|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629898|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629899|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629900|NCT02555722|O6|Outcome|Month 3|enfilcon A lens (control)
629901|NCT02555722|O5|Outcome|Month 2|enfilcon A lens (control)
629902|NCT02555722|O4|Outcome|Month 1|enfilcon A lens (control)
629903|NCT02555722|O3|Outcome|Week 2|enfilcon A lens (control)
629904|NCT02555722|O2|Outcome|Week 1|enfilcon A lens (control)
629905|NCT02555722|O1|Outcome|Baseline|enfilcon A lens (control)
629906|NCT02555722|O6|Outcome|Month 3|fanfilcon A lens (test)
629907|NCT02555722|O5|Outcome|Month 2|fanfilcon A lens (test)
629908|NCT02555722|O4|Outcome|Month 1|fanfilcon A lens (test)
629909|NCT02555722|O3|Outcome|Week 2|fanfilcon A lens (test)
629910|NCT02555722|O2|Outcome|Week 1|fanfilcon A lens (test)
629911|NCT02555722|O1|Outcome|Baseline|fanfilcon A lens (test)
629912|NCT02555722|E2|Reported Event|Enfilcon A (Control)|"Subjects will be randomized to wear enfilcon A lens (control) for one month of daily wear during the study.~enfilcon A (control): silicone hydrogel lens"
629913|NCT02555722|E1|Reported Event|Fanfilcon A (Test)|"Subjects will be randomized to wear fanfilcon A lens (test) for one month of daily wear during the study.~fanfilcon A (test): silicone hydrogel lens"
629914|NCT02555618|B3|Baseline|Total|Total of all reporting groups
629915|NCT02555618|B2|Baseline|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629916|NCT02555618|B1|Baseline|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629917|NCT02555618|P2|Participant Flow|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629918|NCT02555618|P1|Participant Flow|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629919|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629920|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629921|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629922|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629923|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629924|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629925|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629926|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629927|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629928|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629929|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629930|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629931|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629932|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629933|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629934|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629935|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629936|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629937|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629938|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629939|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629940|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629941|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629942|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629943|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629944|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629945|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629946|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629947|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629948|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629949|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629950|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629951|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629952|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629953|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629954|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629955|NCT02555618|O2|Outcome|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629956|NCT02555618|O1|Outcome|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629957|NCT02555618|E2|Reported Event|Influenza HA Vaccine|A single dose of the 0.5 mL influenza HA vaccine (15 μg of HA antigen per strain) is injected subcutaneously into the upper arm.
629958|NCT02555618|E1|Reported Event|TAK-850|A single dose of 0.5 mL TAK-850 (15 μg of hemagglutinin [HA] antigen per strain) is injected subcutaneously into the upper arm.
629959|NCT02554981|B1|Baseline|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629960|NCT02554981|P1|Participant Flow|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629961|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629962|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629963|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629964|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629965|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629966|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629967|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629968|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629969|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
630531|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
629970|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629971|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629972|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629973|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629974|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629975|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629976|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629977|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629978|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629979|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629980|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629981|NCT02554981|O1|Outcome|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629982|NCT02554981|E1|Reported Event|RESTASIS®|1 drop of RESTASIS® ophthalmic emulsion instilled in each eye twice a day for 6 months.
629983|NCT02553629|B3|Baseline|Total|Total of all reporting groups
629984|NCT02553629|B2|Baseline|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629985|NCT02553629|B1|Baseline|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
629986|NCT02553629|P2|Participant Flow|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629987|NCT02553629|P1|Participant Flow|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
629988|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629989|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
629990|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629991|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
629992|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629993|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
629994|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629995|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
629996|NCT02553629|O2|Outcome|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629997|NCT02553629|O1|Outcome|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
629998|NCT02553629|E2|Reported Event|Deep Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a post tetanic count of 1 - 2 twitches~Rocuronium"
629999|NCT02553629|E1|Reported Event|Moderate Neuromuscular Block|"rocuronium 0.1-0.6 mg/kg aimed at a train of four of 1 - 2 twitches~Rocuronium"
630000|NCT02553512|B1|Baseline|Helius|Ingestible Sensor and Wearable Sensor
630001|NCT02553512|P1|Participant Flow|Helius|Ingestible Sensor and Wearable Sensor
630002|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
630003|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
630004|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
630005|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
630006|NCT02553512|O1|Outcome|Helius|Ingestible Sensor and Wearable Sensor
630007|NCT02553512|E1|Reported Event|Helius|Ingestible Sensor and Wearable Sensor
630008|NCT02553421|B3|Baseline|Total|Total of all reporting groups
630009|NCT02553421|B2|Baseline|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
630010|NCT02553421|B1|Baseline|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
630011|NCT02553421|P2|Participant Flow|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
630012|NCT02553421|P1|Participant Flow|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
630013|NCT02553421|O1|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
630584|NCT02540356|B3|Baseline|Total|Total of all reporting groups
630014|NCT02553421|O2|Outcome|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
630015|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
630016|NCT02553421|O1|Outcome|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
630017|NCT02553421|E2|Reported Event|Alarming|"The IV sites will be monitored with the ivWatch Model 400 infiltration notifications enabled.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses."
630018|NCT02553421|E1|Reported Event|Non-alarming|"The ivWatch device will monitor the IV sites but will not issue infiltration notifications.~ivWatch Model 400: The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.~Patients enrolled into the pilot and non-alarming portion of the study were combined for analysis due to no protocol changes between the study arms."
630019|NCT02552810|B3|Baseline|Total|Total of all reporting groups
630020|NCT02552810|B2|Baseline|Control Group|Control group were cleaned by steam for 30s 7 by the dental technician in the laboratory located in the same clinic, but in a different room, immediately before delivering to the clinician. Then all the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
630021|NCT02552810|B1|Baseline|Test Group|Test group abutments, after milled, polished and cleaned for 30s in the same laboratory, underwent argon plasma treatment (75 W of power and -10 MPa of pressure for 12 minutes at room temperature) in a plasma reactor8 located in the same clinic but in a different room. All the abutments were then handed to the clinician in a sterile envelope, without the possibility to evaluate the treatment undergone.
630022|NCT02552810|P2|Participant Flow|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630023|NCT02552810|P1|Participant Flow|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630024|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630025|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630026|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630027|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630042|NCT02551887|P3|Participant Flow|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
630028|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630029|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630030|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630031|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630032|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630033|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630034|NCT02552810|O2|Outcome|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630035|NCT02552810|O1|Outcome|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630036|NCT02552810|E2|Reported Event|Steam Clean|"Cleaning protocol by steaming.~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Steam cleaning: Control group abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 MPa."
630037|NCT02552810|E1|Reported Event|Plasma of Argon|"Abutment cleaning by plasma of Argon protocol .~Dental implant placement: Using a surgical stent, patients received one implant in the anterior or premolar region of the maxilla.~Second stage surgery: After 3 months of healing, a minimally invasive flap for the second surgery procedure was performed.~Abutment connection: Abutments were randomly allocated to control (subjected only to the usually adopted steam cleaning) and test groups (subjected to plasma of argon cleaning).~Plasma of Argon: Test group abutments underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes."
630038|NCT02551887|B4|Baseline|Total|Total of all reporting groups
630039|NCT02551887|B3|Baseline|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
630040|NCT02551887|B2|Baseline|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
630041|NCT02551887|B1|Baseline|Usual Care|Non-interventional study arm. Patients receive usual care.
630585|NCT02540356|B2|Baseline|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630043|NCT02551887|P2|Participant Flow|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
630044|NCT02551887|P1|Participant Flow|Usual Care|Non-interventional study arm. Patients receive usual care.
630045|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
630046|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
630047|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
630048|NCT02551887|O3|Outcome|Automated Reminder Plus Recommended Script|Automated Reminder Plus Recommended Script: In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
630049|NCT02551887|O2|Outcome|Automated Reminder|Automated Reminder: Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
630050|NCT02551887|O1|Outcome|Usual Care|Non-interventional study arm. Patients receive usual care.
630051|NCT02551887|E3|Reported Event|Automated Reminder Plus Recommended Script|In addition to the list of vaccines, health care providers were given a suggested script for recommending vaccination.
630052|NCT02551887|E2|Reported Event|Automated Reminder|Health care providers were given a list of vaccines to consider for administration (MCV4; HPV; Tdap) and asked to check the shots given.
630053|NCT02551887|E1|Reported Event|Usual Care|Patients receive usual care.
630054|NCT02550197|B3|Baseline|Total|Total of all reporting groups
630055|NCT02550197|B2|Baseline|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630056|NCT02550197|B1|Baseline|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630057|NCT02550197|P2|Participant Flow|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630058|NCT02550197|P1|Participant Flow|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630059|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630060|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630061|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630062|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630063|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630064|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630065|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630066|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630067|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630068|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630069|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630070|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630071|NCT02550197|O2|Outcome|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630072|NCT02550197|O1|Outcome|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630073|NCT02550197|E2|Reported Event|Trivalent Influenza Vaccine Group|Participants received one dose of the trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation by the Intramuscular route.
630074|NCT02550197|E1|Reported Event|Quadrivalent Influenza Vaccine Group|Participants received one dose of the quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 formulation by the intramuscular route.
630075|NCT02550132|B1|Baseline|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630076|NCT02550132|P1|Participant Flow|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630077|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630078|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630079|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630080|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630081|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630082|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630083|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630084|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630085|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630086|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630087|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630088|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630089|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630090|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630108|NCT02549027|P5|Participant Flow|MK-6096 20 mg (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of 20 mg of MK-6096 in Period 5.
630586|NCT02540356|B1|Baseline|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630091|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630092|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630093|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630094|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630095|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630096|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630097|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630098|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630099|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630100|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630101|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630102|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630103|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630104|NCT02550132|O1|Outcome|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630105|NCT02550132|E1|Reported Event|Participants|All volunteers will participate in an experimental session. Participants will be delivered four different spinal manipulations (SMT) at T7 with a rate of force application of about 2200 Newtons/seconds and a preload force of 25 Newtons (N). SMTs will differed in their time to peak force (ms) and peak force (N), respectively fixed as follow for each applied SMT: (1)57 ms / 150 N, (2)80 ms / 200 N, (3)102 ms / 250 N and (4)125 ms / 300 N.
630106|NCT02549027|B1|Baseline|All Study Participants|
630107|NCT02549027|P6|Participant Flow|Placebo (Period 5)|Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of placebo in Period 5.
633664|NCT02467777|E1|Reported Event|Forced Air|"Bair Hugger~Bair Hugger"
630109|NCT02549027|P4|Participant Flow|MK-1064: 250 mg→120 mg→50 mg→Placebo (Period 1-4)|Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo.
630110|NCT02549027|P3|Participant Flow|MK-1064: 120 mg→Placebo→250 mg→50 mg (Period 1-4)|Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064.
630111|NCT02549027|P2|Participant Flow|MK-1064: Placebo→50 mg→120 mg→250 mg (Period 1-4)|Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064.
630112|NCT02549027|P1|Participant Flow|MK-1064: 50 mg→250 mg→Placebo→120 mg (Period 1-4)|Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064.
630113|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
630114|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
630115|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
630116|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
630117|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
630118|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
630119|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
630120|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
630121|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
630122|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
630123|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
630124|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
630125|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
630126|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
630127|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
630128|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
630129|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
630130|NCT02549027|O5|Outcome|Placebo|Single dose of placebo
630131|NCT02549027|O4|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
630132|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
630133|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
630134|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
630135|NCT02549027|O2|Outcome|Placebo|Single dose of placebo
630136|NCT02549027|O1|Outcome|MK-6096 20 mg|Single dose of 20 mg MK-6096
630137|NCT02549027|O4|Outcome|Placebo|Single dose of placebo
630138|NCT02549027|O3|Outcome|MK-1064 250 mg|Single dose of 250 mg MK-1064
630139|NCT02549027|O2|Outcome|MK-1064 120 mg|Single dose of 120 mg MK-1064
630140|NCT02549027|O1|Outcome|MK-1064 50 mg|Single dose of 50 mg MK-1064
630141|NCT02549027|E5|Reported Event|Placebo|Single dose of placebo
630142|NCT02549027|E4|Reported Event|MK-6096 20 mg|Single dose of 20 mg MK-6096
630143|NCT02549027|E3|Reported Event|MK-1064 250 mg|Single dose of 250 mg MK-1064
630144|NCT02549027|E2|Reported Event|MK-1064 120 mg|Single dose of 120 mg MK-1064
630145|NCT02549027|E1|Reported Event|MK-1064 50 mg|Single dose of 50 mg MK-1064
630146|NCT02549014|B3|Baseline|Total|Total of all reporting groups
630147|NCT02549014|B2|Baseline|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
630148|NCT02549014|B1|Baseline|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
630149|NCT02549014|P2|Participant Flow|Panel B: MK-1064|Panel B: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 10, 50, 150 and 250 mg over Periods 1-4, in the morning with participants in fasted condition. In Period 5, a single MK-1064 dose of 50 mg or placebo was administered to participants in the evening after a 4-hour fast. Dosing periods alternated with Panel A. There was to be a minimum 7 day wash-out between treatment periods for any given participant.
630150|NCT02549014|P1|Participant Flow|Panel A: MK-1064|Panel A: Eight (8) participants were included in this panel. Within each of up to 5 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 and 2 participants were randomly assigned to receive single oral doses of matching placebo. MK-1064 was administered in rising single doses of 5, 25, 100 and 200 mg over Periods 1-4, in the morning with participants in a fasted condition. In Period 5, a single MK-1064 dose of 25 mg or placebo was administered to participants in the morning following a standard high-fat breakfast. Dosing periods alternated with Panel B. There was to be a minimum 7-day washout between treatment periods for any given participant.
630151|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630152|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630153|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630154|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630155|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630156|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630157|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630158|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630159|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630160|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630161|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630162|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630163|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630164|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630165|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630166|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630167|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630168|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630169|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630170|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630171|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630172|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630173|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630174|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630175|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630176|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630177|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630178|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630256|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
630179|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630180|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630181|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630182|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630183|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630184|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630185|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630186|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630187|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630188|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630189|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630190|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630191|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630192|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630193|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630194|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630195|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630196|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630197|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630198|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630199|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630200|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630201|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630202|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630203|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630204|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630533|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
630205|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630206|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630207|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630208|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630209|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630210|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630211|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630212|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630213|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630214|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630215|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630216|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630217|NCT02549014|O11|Outcome|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630218|NCT02549014|O10|Outcome|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630219|NCT02549014|O9|Outcome|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630220|NCT02549014|O8|Outcome|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630221|NCT02549014|O7|Outcome|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630222|NCT02549014|O6|Outcome|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630223|NCT02549014|O5|Outcome|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630224|NCT02549014|O4|Outcome|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630225|NCT02549014|O3|Outcome|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630226|NCT02549014|O2|Outcome|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630227|NCT02549014|O1|Outcome|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630228|NCT02549014|E11|Reported Event|Panels A & B: Placebo|Within each of up to 5 treatment periods, 2 participants were randomly assigned to receive single oral doses of matching placebo in a fasted stated. There was to be a minimum 7-day washout between treatment periods for any given participant.
630229|NCT02549014|E10|Reported Event|Panel B: MK-1064 50 mg (Night)|In Period 5, 6 participants received a single MK-1064 dose of 50 mg administered in the evening after a 4-hour fast.
630230|NCT02549014|E9|Reported Event|Panel A: MK-1064 25 mg (Fed)|In Period 5, 6 participants received a single MK-1064 dose of 25 mg administered in the evening following a standard high-fat breakfast.
630231|NCT02549014|E8|Reported Event|Panel B: MK-1064 250 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 250 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630232|NCT02549014|E7|Reported Event|Panel A: MK-1064 200 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 200 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630233|NCT02549014|E6|Reported Event|Panel B: MK-1064 150 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 150 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630234|NCT02549014|E5|Reported Event|Panel A: MK-1064 100 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 100 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630235|NCT02549014|E4|Reported Event|Panel B: MK-1064 50 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 50 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630236|NCT02549014|E3|Reported Event|Panel A: MK-1064 25 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 25 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630237|NCT02549014|E2|Reported Event|Panel B: MK-1064 10 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 10 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630238|NCT02549014|E1|Reported Event|Panel A: MK-1064 5 mg|Within each of up to 4 treatment periods, 6 participants were randomly assigned to receive single oral doses of MK-1064 5 mg in a fasted state. There was to be a minimum 7-day washout between treatment periods for any given participant.
630239|NCT02548156|B1|Baseline|Overall Study|All the participants randomized in this study.
630240|NCT02548156|P6|Participant Flow|Sequence 6: Reference/Comparator/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
630241|NCT02548156|P5|Participant Flow|Sequence 5: Reference/Test/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
630242|NCT02548156|P4|Participant Flow|Sequence 4: Comparator/Reference/Test: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
630243|NCT02548156|P3|Participant Flow|Sequence 3: Comparator/Test/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
630244|NCT02548156|P2|Participant Flow|Sequence 2: Test/Reference/Comparator: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse; thirdly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
630245|NCT02548156|P1|Participant Flow|Sequence 1: Test/Comparator/Reference: Dentifrice|Firstly 1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; secondly 1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse; thirdly 1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL DI water rinse were given to participants in Period 1, Period 2 and Period 3 respectively. Each period was separated by washout period of 7+/-1 day.
630246|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630247|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
630248|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630249|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630250|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
630251|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630252|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630253|NCT02548156|O2|Outcome|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
630254|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630255|NCT02548156|O3|Outcome|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
639380|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
630257|NCT02548156|O1|Outcome|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630258|NCT02548156|E3|Reported Event|Comparator Dentifrice|1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630259|NCT02548156|E2|Reported Event|Reference Dentifrice|1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
630260|NCT02548156|E1|Reported Event|Test Dentifrice|1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
630261|NCT02547454|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630262|NCT02547454|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with chronic kidney disease (CKD), who did not require dialysis, received methoxy polyethylene glycol-epoetin beta (Mircera) either intravenously (IV) or subcutaneously (SC), as per routine clinical practice, and were followed for approximately 36 months.
630263|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630264|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630265|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630266|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630267|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630268|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630269|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630270|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630271|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630272|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630273|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630274|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630275|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630276|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630277|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630278|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630279|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630280|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630281|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630282|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630283|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630284|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
639381|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
630285|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630286|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630287|NCT02547454|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630288|NCT02547454|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with CKD, who did not require dialysis, received methoxy polyethylene glycol-epoetin beta either IV or SC, as per routine clinical practice, and were followed for approximately 36 months.
630289|NCT02547064|B3|Baseline|Total|Total of all reporting groups
630290|NCT02547064|B2|Baseline|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630291|NCT02547064|B1|Baseline|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630292|NCT02547064|P2|Participant Flow|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630293|NCT02547064|P1|Participant Flow|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630294|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630295|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630296|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630297|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630298|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630299|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630300|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630301|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630302|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630303|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630304|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630305|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630306|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630307|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630308|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630309|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630310|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630311|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630312|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630313|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630314|NCT02547064|O2|Outcome|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630315|NCT02547064|O1|Outcome|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630316|NCT02547064|E2|Reported Event|70 Degree|"The ETT was bent by 70° at a point 6 cm from its distal end and the proximal portion of the ETT was formed as the shape of the GL blade until the point of the handle.~Glidescope guided intubation~GlideScope®"
630317|NCT02547064|E1|Reported Event|90 Degree|"The ETT with the 90° angle stylet was bent at a point 8 cm from its distal end.~Glidescope guided intubation~GlideScope®"
630318|NCT02545543|B3|Baseline|Total|Total of all reporting groups
639382|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
630319|NCT02545543|B2|Baseline|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630320|NCT02545543|B1|Baseline|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630321|NCT02545543|P2|Participant Flow|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630322|NCT02545543|P1|Participant Flow|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630323|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630324|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630325|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630326|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630327|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630328|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630354|NCT02543918|B3|Baseline|Total|Total of all reporting groups
630902|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630534|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
630329|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630330|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630331|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630332|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630333|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630334|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630335|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630336|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630337|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630338|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630355|NCT02543918|B2|Baseline|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
630589|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630339|NCT02545543|O2|Outcome|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630340|NCT02545543|O1|Outcome|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630341|NCT02545543|O1|Outcome|SCR Difference = Comparator QIV SCR % Minus Seqirus QIV SCR %|Seroconversion rate difference = Comparator QIV SCR percentage minus Seqirus QIV SCR percentage
630342|NCT02545543|O1|Outcome|GMT Ratios: GMT Comparator QIV Over GMT Seqirus QIV|GMT Ratios: GMT Comparator Quadrivalent Influenza Vaccine over GMT Seqirus Quadrivalent Influenza Vaccine
630343|NCT02545543|E2|Reported Event|Comparator Quadrivalent Influenza Vaccine|"The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season.~Comparator QIV: The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630344|NCT02545543|E1|Reported Event|Seqirus Quadrivalent Influenza Vaccine|"The Seqirus study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2015/2016 influenza season).~Seqirus QIV: Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.~The subject’s age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
630345|NCT02545322|B1|Baseline|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
630346|NCT02545322|P1|Participant Flow|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
630347|NCT02545322|O1|Outcome|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
630348|NCT02545322|O1|Outcome|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
630349|NCT02545322|E1|Reported Event|Adaptive Radiotherapy|"Follow-up CT scans during week 3 and week 5 of Treatment~Image-guided adaptive Radiotherapy arm:~Follow-up CT scans are performed on a conventional CT-simulator. Deformable Image Registration between the planning-CT and the follow-up CT (fCT) is done using a dedicated Software package. Delineations for target volumes and organs at risk are transferred to the fCT based on the Deformation vector fields calculated during deformable Image registration. Volumetric changes in target volumes and organs-at-risk are assessed. The initial treatment plan is transferred to the fCT scan. Dosimetric consequences of morphologic changes are analysed with the Focus on target dose coverage for the planning target volume. Adaption and plan re-optimisation are performed."
630356|NCT02543918|B1|Baseline|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
630357|NCT02543918|P2|Participant Flow|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by intramuscular (IM) injection into opposing arms at week 2.
630358|NCT02543918|P1|Participant Flow|Ixekizumab + Boostrix® + Pneumovax®23|"Ixekizumab administered once by subcutaneous injection (SQ) at week 0 and once at week 2.~Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2."
630359|NCT02543918|O2|Outcome|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
630360|NCT02543918|O1|Outcome|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
630361|NCT02543918|E2|Reported Event|Boostrix® + Pneumovax®23|Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
630362|NCT02543918|E1|Reported Event|Ixekizumab + Boostrix® + Pneumovax®23|Ixekizumab administered once by SQ at week 0 and once at week 2. Boostrix® and Pneumovax®23 administered once by IM injection into opposing arms at week 2.
630363|NCT02543437|B1|Baseline|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
630364|NCT02543437|P1|Participant Flow|Trident Acetabular X3 Insert|Trident Acetabular X3 Insert 28mm, 32mm and 36mm liner
630365|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
630366|NCT02543437|O1|Outcome|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
630367|NCT02543437|E1|Reported Event|X3 Liner|"X3 28mm, 32mm and 36mm liner~Trident Acetabular X3 Insert"
630368|NCT02542943|B4|Baseline|Total|Total of all reporting groups
630369|NCT02542943|B3|Baseline|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630370|NCT02542943|B2|Baseline|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630371|NCT02542943|B1|Baseline|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630372|NCT02542943|P3|Participant Flow|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630373|NCT02542943|P2|Participant Flow|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630374|NCT02542943|P1|Participant Flow|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% weight by weight (w/w) dipotasium oxalate monohydrate [KOX], pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630375|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630376|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630377|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630378|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630379|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630380|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630381|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630382|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630383|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630384|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630385|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630386|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630387|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630388|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
639383|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
630389|NCT02542943|O1|Outcome|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630390|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630391|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630392|NCT02542943|O3|Outcome|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630393|NCT02542943|O2|Outcome|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630394|NCT02542943|O1|Outcome|Experimental Oral Rinse1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630395|NCT02542943|E3|Reported Event|Placebo Oral Rinse|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Placebo Oral Rinse (0% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630396|NCT02542943|E2|Reported Event|Experimental Oral Rinse 2|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 2 (1.5% w/w KOX, pH 7) for 1 minute. This regimen was performed twice daily for 8 weeks.
630397|NCT02542943|E1|Reported Event|Experimental Oral Rinse 1|Brushing with fluoride toothpaste for 1 minute followed by rinsing with 10 mL of Experimental Oral Rinse 1 (1.5% w/w KOX, pH 4.5) for 1 minute. This regimen was performed twice daily for 8 weeks.
630398|NCT02542280|B3|Baseline|Total|Total of all reporting groups
630399|NCT02542280|B2|Baseline|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630400|NCT02542280|B1|Baseline|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630401|NCT02542280|P2|Participant Flow|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630402|NCT02542280|P1|Participant Flow|Endometrial Injury|"Endometrial injury during ovarian stimulation cycle combined with intrauterine insemination.~endometrial injury: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by clomiphene citrate 100mg orally (from cycle day 2 for 5 days) and human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630403|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630404|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630405|NCT02542280|O2|Outcome|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630406|NCT02542280|O1|Outcome|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630407|NCT02542280|E2|Reported Event|no Endometrial Injury|"Ovarian stimulation combined with intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630408|NCT02542280|E1|Reported Event|Endometrial Injury|"Endometrial injury during ovarian stimulation combined with intrauterine insemination.~endometrial injury.: Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.~intrauterine insemination: Placement of washed sperm in the uterus using a catheter, around the time of ovulation.~ovarian stimulation: Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm."
630409|NCT02542072|B1|Baseline|Overall Baseline Characteristics|"Participants were randomized to wear the comfilcon A lens pair or samfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lenses~samfilcon A: contact lenses"
630410|NCT02542072|P2|Participant Flow|Samfilcon A, Then Comfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month then cross over to the comfilcon A lens pair.~samfilcon A: contact lens~comfilcon A: contact lens"
630411|NCT02542072|P1|Participant Flow|Comfilcon A, Then Samfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month, then cross over to the samfilcon A lens pair.~comfilcon A: contact lens~samfilcon A: contact lens"
630412|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630413|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630414|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630415|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630416|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
630417|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630418|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630419|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630420|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630421|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630422|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630423|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630424|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630425|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630426|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630427|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630428|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630429|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630430|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630431|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630432|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630433|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630434|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630435|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630436|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630437|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630438|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630439|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630440|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630441|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630442|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630443|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630444|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630530|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
630445|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630446|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630447|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630448|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630449|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630450|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630451|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630452|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630453|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630454|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630455|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630456|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630457|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
630458|NCT02542072|O4|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630459|NCT02542072|O3|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630460|NCT02542072|O2|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630461|NCT02542072|O1|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630462|NCT02542072|O4|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630463|NCT02542072|O3|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630464|NCT02542072|O2|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630465|NCT02542072|O1|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630466|NCT02542072|O6|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630467|NCT02542072|O5|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630468|NCT02542072|O4|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630469|NCT02542072|O3|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630470|NCT02542072|O2|Outcome|Samfilcon A (Baseline)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630471|NCT02542072|O1|Outcome|Comfilcon A (Baseline)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630472|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630473|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630474|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630475|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630476|NCT02542072|O1|Outcome|Habitual Lenses (Baseline)|Habitual data were collected of participants before lens dispensed.
630477|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630478|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630479|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630480|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630481|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
630482|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630483|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630484|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630485|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630486|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
630487|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630488|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630489|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630490|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630491|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
630492|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630493|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630494|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630495|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630496|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
630497|NCT02542072|O6|Outcome|Samfilcon A (Day 26)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630498|NCT02542072|O5|Outcome|Comfilcon A (Day 26)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630499|NCT02542072|O4|Outcome|Samfilcon A (Day 12)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630500|NCT02542072|O3|Outcome|Comfilcon A (Day 12)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630501|NCT02542072|O2|Outcome|Samfilcon A (Day 3)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630502|NCT02542072|O1|Outcome|Comfilcon A (Day 3)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630503|NCT02542072|O5|Outcome|Samfilcon A (4 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630504|NCT02542072|O4|Outcome|Comfilcon A (4 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630505|NCT02542072|O3|Outcome|Samfilcon A (2 Weeks)|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630506|NCT02542072|O2|Outcome|Comfilcon A (2 Weeks)|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630507|NCT02542072|O1|Outcome|Habitual Lens (Baseline)|Habitual data were collected of participants before lens dispensed.
630508|NCT02542072|E2|Reported Event|Samfilcon A|"Participants were randomized to wear the samfilcon A lens pair for one month during the cross over study.~samfilcon A: contact lens"
630509|NCT02542072|E1|Reported Event|Comfilcon A|"Participants were randomized to wear the comfilcon A lens pair for one month during the cross over study.~comfilcon A: contact lens"
630510|NCT02540850|B4|Baseline|Total|Total of all reporting groups
630511|NCT02540850|B3|Baseline|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630512|NCT02540850|B2|Baseline|Precancerous Disease Group|subjects with adenoma or polyps
630513|NCT02540850|B1|Baseline|CRC Group|stage 0-IV CRC subjects
630514|NCT02540850|P3|Participant Flow|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630515|NCT02540850|P2|Participant Flow|Precancerous Disease Group|subjects with adenoma or polyps
630516|NCT02540850|P1|Participant Flow|CRC Group|stage 0-IV CRC subjects
630517|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630518|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
630519|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
630520|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630521|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
630522|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
630523|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630524|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
630525|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
630526|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630527|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
630528|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
630529|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630532|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630535|NCT02540850|O3|Outcome|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630536|NCT02540850|O2|Outcome|Precancerous Disease Group|subjects with adenoma or polyps
630537|NCT02540850|O1|Outcome|CRC Group|stage 0-IV CRC subjects
630538|NCT02540850|E3|Reported Event|Other Disease Group|subjects with other bowel diseases, other cancers, and subjects with no evidence of disease
630539|NCT02540850|E2|Reported Event|Precancerous Disease Group|subjects with adenoma or polyps
630540|NCT02540850|E1|Reported Event|CRC Group|stage 0-IV CRC subjects
630541|NCT02540772|B3|Baseline|Total|Total of all reporting groups
630542|NCT02540772|B2|Baseline|No Treatment|Patients in the control group only performed the baselines.
630543|NCT02540772|B1|Baseline|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
630544|NCT02540772|P2|Participant Flow|No Treatment|Patients in the control group only performed the baselines.
630545|NCT02540772|P1|Participant Flow|Neuropsychological Treatment|"The tested treatment is a combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.~Neuropsychological treatment: Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors. This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment."
630546|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
630547|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
630548|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
630549|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
630550|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
630551|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
630552|NCT02540772|O2|Outcome|No Treatment|Patients in the control group only performed the baselines.
630553|NCT02540772|O1|Outcome|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
630554|NCT02540772|E2|Reported Event|No Treatment|Patients in the control group only performed the baselines.
630555|NCT02540772|E1|Reported Event|Neuropsychological Treatment|Combination of neuropsychological rehabilitation procedures: learning, episodic memory recall after a delay, selective attention, inhibition of predominant responses and awareness of deficits.
630556|NCT02540447|B3|Baseline|Total|Total of all reporting groups
630557|NCT02540447|B2|Baseline|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630558|NCT02540447|B1|Baseline|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630559|NCT02540447|P2|Participant Flow|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630560|NCT02540447|P1|Participant Flow|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630587|NCT02540356|P2|Participant Flow|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630561|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630590|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630562|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630563|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630564|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630565|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630566|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630567|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630568|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630569|NCT02540447|O2|Outcome|No Purge|Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630570|NCT02540447|O1|Outcome|Purge|"Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630571|NCT02540447|E2|Reported Event|No Purge|The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold Custodiol (4°C solution, Both portal vein and RHV were completely anastomosed prior to portal declamping and the graft preservative contents were washed into the systemic circulation by the portal blood at portal declamping.
630572|NCT02540447|E1|Reported Event|Purge|"The donor surgical team excised the right liver lobe (without inclusion of the middle hepatic vein) and preserved it on the back table with cold custodiol (4°C solution, Portal vein (PV) was completely anastomosed and the right hepatic vein (RHV) was anastomosed with the recipient hepatic vein apart from last suture” that was left for drainage of the liver graft contents of the preservative solution into the peritoneal cavity using portal blood after portal declamping based on the graft volume and suctioned through an external sucker, then completed the RHV anastomosis.~Purge of graft contents out of the circulation: In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping"
630573|NCT02540434|B3|Baseline|Total|Total of all reporting groups
630574|NCT02540434|B2|Baseline|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
630588|NCT02540356|P1|Participant Flow|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
639384|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
630591|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
639389|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
630575|NCT02540434|B1|Baseline|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
630576|NCT02540434|P2|Participant Flow|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
630577|NCT02540434|P1|Participant Flow|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
630578|NCT02540434|O2|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cry"
630579|NCT02540434|O1|Outcome|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
630580|NCT02540434|O2|Outcome|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if the ROTEM FIBTEM A10 value less than or equal to 10 mm and microvascular bleeding is present.~ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate"
630581|NCT02540434|O1|Outcome|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.~ROTEM: ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.~RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen"
630582|NCT02540434|E2|Reported Event|RiaSTAP Arm|"Subjects will be infused with RiaSTAP if the ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present.RiaSTAP: Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen.~Only enrolled patients randomized to RiaSTAP are at risk for riastap-related adverse events. 0 subjects out of total 22 consented were randomized to this arm, so no subjects were at risk to adverse events from this arm."
630583|NCT02540434|E1|Reported Event|Cryopreciptiate Arm|"Subjects will be infused with cryoprecipitate if ROTEM FIBTEM A10 value is less than or equal to 10 mm and microvascular bleeding is present. ROTEM delta will be used to identify intraoperative coagulation abnormalities. Cryoprecipitate: Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate.~Only enrolled patients randomized to cryoprecipitate arm are at risk for cryoprecipitate-related adverse events. 1 subject out of total 22 consented were randomized to this arm, so 1 subject was at risk to adverse events from this arm. No events were reported."
630592|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630593|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630594|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630595|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630596|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630597|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630598|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630599|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630600|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630601|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630602|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630603|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630604|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630605|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630606|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630607|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630608|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630609|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630610|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630611|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630612|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630613|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630614|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630615|NCT02540356|O2|Outcome|Double-Route Arm|BAX69 administered weekly by intravenous (IV) infusion + intraperitoneal (IP) infusion
630616|NCT02540356|O1|Outcome|Single-Route Arm|BAX69 administered weekly by intraperitoneal (IP) infusion only
630617|NCT02540356|E1|Reported Event|Overall Trial|Treatment with Imalumab (BAX69) over a 4-week treatment period.
630618|NCT02540265|B4|Baseline|Total|Total of all reporting groups
630619|NCT02540265|B3|Baseline|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630620|NCT02540265|B2|Baseline|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630621|NCT02540265|B1|Baseline|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630622|NCT02540265|P3|Participant Flow|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630623|NCT02540265|P2|Participant Flow|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630624|NCT02540265|P1|Participant Flow|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630625|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630626|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630627|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630628|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630629|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630630|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630631|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630632|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630633|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630634|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630635|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630636|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630637|NCT02540265|O3|Outcome|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630638|NCT02540265|O2|Outcome|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630639|NCT02540265|O1|Outcome|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630640|NCT02540265|E3|Reported Event|IV Placebo|"IV Placebo every 24 hours for up to 3 doses.~Intravenous Placebo"
630641|NCT02540265|E2|Reported Event|N1539 60mg|"N1539 (Intravenous meloxicam) 60mg every 24 hours for up to 3 doses.~N1539"
630642|NCT02540265|E1|Reported Event|N1539 30mg|"N1539 (Intravenous meloxicam) 30mg every 24 hours for up to 3 doses.~N1539"
630678|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630748|NCT02537522|P2|Participant Flow|Control/Test - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 9.0 Base Curve in their left eye and then wore the narafilcon A with 8.5 Base Curve in their right eye.
630643|NCT02540213|B1|Baseline|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630644|NCT02540213|P1|Participant Flow|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 micrograms per kilogram (mcg/kg) body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 grams per deciliter (g/dL), the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight)..
630645|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630646|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630647|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630648|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630649|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630650|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630651|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630652|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630653|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630654|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630655|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630656|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630657|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630747|NCT02537522|P3|Participant Flow|Test/Control - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 8.5 Base Curve in both eyes and then wore narafilcon A lens with 9.0 Base Curve in both eyes.
639385|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
630658|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630659|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630660|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630661|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630662|NCT02540213|O1|Outcome|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630663|NCT02540213|E1|Reported Event|MIRCERA|Participants receiving MIRCERA ready-to-use-syringes (methoxy polyethylene glycol epoetin beta) at the discretion of treating physician were followed for 9 months. The recommended starting dose for MIRCERA in naive participants was 0.6 mcg/kg body weight, administered at intervals of 2 weeks. After hemoglobin value reached the target level of 11 g/dL, the interval of administration could be adopted to one monthly dose (1.2 mcg/kg body weight).
630664|NCT02539992|B4|Baseline|Total|Total of all reporting groups
630665|NCT02539992|B3|Baseline|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630666|NCT02539992|B2|Baseline|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630667|NCT02539992|B1|Baseline|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630668|NCT02539992|P3|Participant Flow|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630669|NCT02539992|P2|Participant Flow|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630670|NCT02539992|P1|Participant Flow|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630671|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630672|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630673|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630674|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630675|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630676|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630677|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
639705|NCT02359955|O3|Outcome|Group 1 Anatomic Teeth|
630679|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630680|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630681|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630682|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630683|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630684|NCT02539992|O2|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630685|NCT02539992|O1|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630686|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630687|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630688|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630689|NCT02539992|O3|Outcome|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630690|NCT02539992|O2|Outcome|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630691|NCT02539992|O1|Outcome|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630692|NCT02539992|E3|Reported Event|Triathlon® CR/Conventional Limb Alignment|"Receive the Triathlon® CR device in a procedure using traditional instrumentation intended to achieve a neutral overall limb alignment of the knee.~Triathlon® CR/Conventional Limb Alignment: Total knee replacement using traditional instrumentation"
630693|NCT02539992|E2|Reported Event|Triathlon® CR/Neutral Overall Limb Alignment|"Receive the Triathlon® CR device in a procedure using patient-specific cutting guides modified to provide neutral overall limb alignment of the knee.~Triathlon® CR/Neutral Overall Limb Alignment: Total knee replacement using patient-specific cutting guides"
630694|NCT02539992|E1|Reported Event|Triathlon® CR/Kinematic Alignment|"Receive the Triathlon® Cruciate Retaining Total Knee System (Triathlon® CR) in a procedure using patient-specific cutting guides to reproduce the natural kinematic alignment of the knee.~Triathlon® CR/Kinematic Alignment: Total knee replacement using patient-specific cutting guides"
630695|NCT02539108|B3|Baseline|Total|Total of all reporting groups
630696|NCT02539108|B2|Baseline|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630697|NCT02539108|B1|Baseline|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630698|NCT02539108|P2|Participant Flow|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630699|NCT02539108|P1|Participant Flow|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630700|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630899|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630701|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630702|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630703|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630704|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630705|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630706|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630707|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630708|NCT02539108|O2|Outcome|3 to <9 Years of Age|Children 3 to <9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630709|NCT02539108|O1|Outcome|6 to <36 Months of Age|Children 6 to <36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630710|NCT02539108|E2|Reported Event|3 to <9 Years of Age|Children 3 to < 9 years of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630711|NCT02539108|E1|Reported Event|6 to <36 Months of Age|Children 6 to < 36 months of age received 1 intramuscular dose of Fluzone Quadrivalent Vaccine. A second dose was administered 28 days after the first vaccination in participants for whom a second dose was recommended according to Advisory Committee on Immunization Practices guidelines.
630712|NCT02538107|B1|Baseline|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630713|NCT02538107|P1|Participant Flow|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630714|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630715|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630716|NCT02538107|O2|Outcome|GFR (30-60 mL/Min)-Kidney Transplant Participants|Participants with GFR in the range of 30-60 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630717|NCT02538107|O1|Outcome|GFR (<30 mL/Min)-Kidney Transplant Participants|Participants with GFR <30 mL/min with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630718|NCT02538107|O2|Outcome|Presence of Acute Bleeding-Kidney Transplant Participants|Participants with presence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630719|NCT02538107|O1|Outcome|Absence of Acute Bleeding-Kidney Transplant Participants|Participants with absence of acute bleeding episodes during the study with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630720|NCT02538107|O2|Outcome|Other Reason-Kidney Transplant Participants|Participants with unspecified other reasons as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630721|NCT02538107|O1|Outcome|Glomerulonephritis-Kidney Transplant Participants|Participants with glomerulonephritis as the cause of chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630722|NCT02538107|O2|Outcome|Inflammatory Diseases Absent-Kidney Transplant Participants|Participants with chronic kidney disease and absence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630900|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630723|NCT02538107|O1|Outcome|Inflammatory Diseases Present-Kidney Transplant Participants|Participants with chronic kidney disease and presence of other inflammatory diseases at baseline who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630724|NCT02538107|O2|Outcome|Cadaveric Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'cadaveric donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630725|NCT02538107|O1|Outcome|Living Donation-Kidney Transplant Participants|Participants with chronic kidney disease who underwent 'living donation' type of kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630726|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630727|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630728|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630729|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630730|NCT02538107|O1|Outcome|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630731|NCT02538107|E1|Reported Event|Kidney Transplant Participants|Participants with chronic kidney disease who underwent kidney transplantation and received methoxy polyethylene glycol epoetin beta (Mircera) as part of their medical care were observed and documented for up to 15 months.
630732|NCT02537730|B1|Baseline|Overall Participants|Participants were randomized to the Bioclean MPS VII / comfilcon A combination or Aosept Clearcare / comfilcon A combination for one week, then cross over to the alternative combination.
630733|NCT02537730|P2|Participant Flow|Aosept Clearcare Combo, Then Bioclean MPS VII Combo|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week then cross over to the alternative Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
630734|NCT02537730|P1|Participant Flow|Bioclean MPS VII Combo, Then Aosept Clearcare Combo|"Participants were randomized to the Bioclean MPS (Multi-Purpose Solution) VII / comfilcon A combination for one week, then cross over to the alternative Aosept Clearcare / comfilcon A combination~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
630735|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
630736|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
630737|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
630738|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
630739|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
630740|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
630741|NCT02537730|O2|Outcome|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
630742|NCT02537730|O1|Outcome|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
630743|NCT02537730|E2|Reported Event|Aosept Clearcare / Comfilcon A Combination|"Participants were randomized to the Aosept Clearcare / comfilcon A combination for one week during the cross over study.~Aosept Clearcare: Hydrogen Peroxide Disinfecting and Cleaning system~comfilcon A: contact lens"
630744|NCT02537730|E1|Reported Event|Bioclean MPS VII / Comfilcon A Combination|"Participants were randomized to the Bioclean MPS VII / comfilcon A combination for one week during the cross over study.~Bioclean MPS VII: PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system~comfilcon A: contact lens"
630745|NCT02537522|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens throughout the course of the study.
630746|NCT02537522|P4|Participant Flow|Control/Test - Phase 2|Subjects randomized to this sequence in Phase II wore the narafilcon A lens with 9.0 Base Curve in both eyes and then wore narafilcon A lens with 8.5 Base Curve in both eyes.
630749|NCT02537522|P1|Participant Flow|Test/Control - Phase 1|Subjects randomized to this sequence in Phase I wore the test lens narafilcon A with 8.5 Base Curve in their left eye and then wore the narafilcon A with 9.0 Base Curve in their right eye.
630750|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
630751|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
630752|NCT02537522|O2|Outcome|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during Phase II.
630753|NCT02537522|O1|Outcome|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during Phase II.
630754|NCT02537522|E2|Reported Event|Narafilcon A- 9.0 Base Curve|Subjects that wore the narafilcon A lens with 9.0 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
630755|NCT02537522|E1|Reported Event|Narafilcon A- 8.5 Base Curve|Subjects that wore the narafilcon A lens with 8.5 Base Curve in either the 1st or 2nd period of the study during either Phase I or II.
630756|NCT02536664|B3|Baseline|Total|Total of all reporting groups
630757|NCT02536664|B2|Baseline|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630758|NCT02536664|B1|Baseline|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630759|NCT02536664|P2|Participant Flow|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630760|NCT02536664|P1|Participant Flow|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the cluster of differentiation (CD) 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630761|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630762|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630763|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630764|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630765|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630766|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630767|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630768|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630769|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630770|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630771|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630772|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630773|NCT02536664|O2|Outcome|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630774|NCT02536664|O1|Outcome|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630775|NCT02536664|E2|Reported Event|Relapsed/Refractory Stratum|Participants who relapsed after treatment with chemotherapeutic regimens with or without Rituximab and were decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630776|NCT02536664|E1|Reported Event|First-line Stratum|Participants who were untreated and decided by the treating physician to be treated with Rituximab for the CD 20-positive follicular lymphoma condition, were observed for a maximum of 2 years.
630777|NCT02535741|B1|Baseline|Triathlon CR Total Knee System|Progressive data: Primary total knee replacement
630778|NCT02535741|P1|Participant Flow|Triathlon CR Total Knee System|"Primary total knee replacement~Triathlon CR Total Knee System: Primary total knee replacement"
630779|NCT02535741|O1|Outcome|Triathlon CR Total Knee System|Prospective data of the Triathlon CR primary total knee replacement
630780|NCT02535741|E1|Reported Event|Triathlon CR Total Knee System|Triathlon CR Primary total knee replacement
630781|NCT02535026|B1|Baseline|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
630782|NCT02535026|P1|Participant Flow|Breast Cancer (BC) Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
630783|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
630784|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
630785|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
630786|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
630787|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
630788|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
630789|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
630790|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
630791|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
630792|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
630793|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
630794|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
630795|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
630796|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
630797|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
630798|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
630799|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
630800|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
630801|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
630901|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630802|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
630803|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
630804|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
630805|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
630806|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
630807|NCT02535026|O4|Outcome|BC Participants-Triple Negative Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with triple negative phenotype were included in this group.
630808|NCT02535026|O3|Outcome|BC Participants-HER2 Enriched Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2 phenotype were included in this group.
630809|NCT02535026|O2|Outcome|BC Participants-Luminal B Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal B phenotype were included in this group.
630810|NCT02535026|O1|Outcome|BC Participants-Luminal A Phenotype|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with luminal A phenotype were included in this group.
630811|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
630812|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
630813|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
630814|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
630815|NCT02535026|O2|Outcome|Breast Cancer Participants (HER2+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2+ status were included in this group.
630816|NCT02535026|O1|Outcome|Breast Cancer Participants (HER2-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with HER2- status were included in this group.
630817|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
630818|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
630819|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
630820|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
630821|NCT02535026|O2|Outcome|Breast Cancer Participants (PR+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR+ status were included in this group.
630822|NCT02535026|O1|Outcome|Breast Cancer Participants (PR-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with PR- status were included in this group.
630823|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
630824|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
630825|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
630826|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
630827|NCT02535026|O2|Outcome|Breast Cancer Participants (ER+)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER+ status were included in this group.
630828|NCT02535026|O1|Outcome|Breast Cancer Participants (ER-)|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies with ER- status were included in this group.
630829|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
630830|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
630831|NCT02535026|O1|Outcome|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
630832|NCT02535026|E1|Reported Event|Breast Cancer Participants|Breast tissue samples from female participants with a breast cancer diagnosis that underwent an anatomopathological examination of surgical specimens and/or core needle biopsies were considered for analysis in this study.
630833|NCT02534324|B3|Baseline|Total|Total of all reporting groups
630834|NCT02534324|B2|Baseline|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630835|NCT02534324|B1|Baseline|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630836|NCT02534324|P2|Participant Flow|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630837|NCT02534324|P1|Participant Flow|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630838|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630839|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630840|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630841|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630842|NCT02534324|O2|Outcome|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630843|NCT02534324|O1|Outcome|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630844|NCT02534324|E2|Reported Event|Severely High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge >= 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630867|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630868|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630845|NCT02534324|E1|Reported Event|High SBP+Antihypertensive Meds|"Patients with pre-discharge systolic blood pressure at discharge < 180 mmHg~Antihypertensive meds: Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians."
630846|NCT02533466|B3|Baseline|Total|Total of all reporting groups
630847|NCT02533466|B2|Baseline|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
630848|NCT02533466|B1|Baseline|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush and swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630849|NCT02533466|P2|Participant Flow|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630850|NCT02533466|P1|Participant Flow|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630851|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
630852|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
630853|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
630854|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water
630855|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630856|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630857|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630858|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630859|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630860|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630861|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630862|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630863|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630864|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630865|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630866|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630897|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630898|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630869|NCT02533466|O2|Outcome|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630870|NCT02533466|O1|Outcome|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630871|NCT02533466|E2|Reported Event|Reference Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630872|NCT02533466|E1|Reported Event|Test Product|Participants applied a full ribbon of dentifrice and brushed their teeth for 1 timed minute using a wet toothbrush, swished the resulting slurry around the mouth for 30 seconds making sure it contacted the selected teeth, spitted out slurry and rinsed mouth for 10 seconds with water.
630873|NCT02533401|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630874|NCT02533401|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via intravenous (IV) infusion as 375 milligrams per meter-squared (mg/m^2) on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630875|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630876|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630877|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630878|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630879|NCT02533401|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630880|NCT02533401|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|Participants with CLL received 6 treatment cycles of chemotherapy. Rituximab was administered via IV infusion as 375 mg/m^2 on Day 1 of Cycle 1 and as 500 mg/m^2 on Day 1 of Cycles 2 to 6. Fludarabine was given as 25 mg/m^2 daily and cyclophosphamide as 250 mg/m^2 daily, each via IV infusion on Days 2 to 4 during Cycle 1 and on Days 1 to 3 during Cycles 2 to 6. The length of each cycle was 28 days.
630881|NCT02532998|B1|Baseline|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
630882|NCT02532998|P1|Participant Flow|All Particpants|Twenty three healthy male participants aged 18 to 50 years who satisfied all the study inclusion criteria were included in the study
630883|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630884|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630885|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630886|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630887|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630888|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630889|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630890|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630891|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630892|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630893|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630894|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630895|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630896|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630903|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630904|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
640299|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
630905|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630906|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630907|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630908|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630909|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630910|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630911|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630912|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630913|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630914|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630915|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630916|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630917|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630918|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630919|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630920|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630921|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630922|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630923|NCT02532998|O4|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630924|NCT02532998|O3|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630925|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630926|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630927|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630928|NCT02532998|O1|Outcome|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
630929|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630930|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630931|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630932|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630933|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630934|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630935|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630936|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630937|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630938|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630939|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630940|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630941|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630942|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630943|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630944|NCT02532998|O1|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630945|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630946|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630947|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630948|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630949|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630950|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630951|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630952|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630953|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630954|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630955|NCT02532998|O2|Outcome|Treatment B|Participants received fludrocortisone + AZD9977
630956|NCT02532998|O1|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630957|NCT02532998|O2|Outcome|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630958|NCT02532998|O1|Outcome|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630959|NCT02532998|E4|Reported Event|Treatment D|Participants received fludrocortisone + eplerenone + AZD9977
630960|NCT02532998|E3|Reported Event|Treatment C|Participants received fludrocortisone + eplerenone + AZD9977 Placebo.
630961|NCT02532998|E2|Reported Event|Treatment B|Participants received fludrocortisone + AZD9977
630962|NCT02532998|E1|Reported Event|Treatment A|Participants received fludrocortisone + AZD9977 Placebo
631026|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
631027|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
640256|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
631030|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
640300|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
630963|NCT02532374|B1|Baseline|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.~Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).~P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
630964|NCT02532374|P1|Participant Flow|Nicorette® Inhalator Then P3L|"Each subject will use the Nicorette® inhalator (15 mg) on Visit 3, and then use the P3L aerosol at nicotine dose levels of approximately 50 µg/puff, 80 µg/puff and 150 µg/puff on Visits 4, 5 and 6, respectively.~Nicorette® inhalator: Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).~P3L: Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total)."
630965|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630966|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630967|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630968|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
630969|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630970|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630971|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630972|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
630973|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630974|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630975|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630976|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
630977|NCT02532374|O1|Outcome|P3L 150 µg/Puff|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630978|NCT02532374|O1|Outcome|P3L 80 µg/Puff|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630979|NCT02532374|O1|Outcome|P3L 50 µg/Puff|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630980|NCT02532374|O1|Outcome|Nicorette® Inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
630981|NCT02532374|E6|Reported Event|Safety Follow-up Period|All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator entered a 7-day safety follow-up period during which (serious) adverse events can be spontaneously reported by the subjects.
630982|NCT02532374|E5|Reported Event|P3L 150 µg/Puff Period|Subjects inhaled P3L 150 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630983|NCT02532374|E4|Reported Event|P3L 80 µg/Puff Period|Subjects inhaled P3L 80 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630984|NCT02532374|E3|Reported Event|P3L 50 µg/Puff Period|Subjects inhaled P3L 50 µg/puff at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
630985|NCT02532374|E2|Reported Event|Nicorette® Inhalator Period|Subjects inhaled the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
630986|NCT02532374|E1|Reported Event|Enrolment Period|"All subjects who have signed the ICF, and who have been exposed to P3L and/or Nicorette® inhalator.~Product test period - from enrolment to admission."
630987|NCT02531867|B1|Baseline|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
630988|NCT02531867|P1|Participant Flow|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
630989|NCT02531867|O1|Outcome|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
640257|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
630990|NCT02531867|E1|Reported Event|Overall Study|Patients enrolled in this study received a total of 6 mg/kg/week asfotase alfa by SC injection. At the Investigator’s discretion, patients were continued on the dose established in the Investigator-initiated studies, receiving either 1 mg/kg asfotase alfa 6 times per week or 2 mg/kg asfotase alfa 3 times per week.
630991|NCT02531646|B4|Baseline|Total|Total of all reporting groups
630992|NCT02531646|B3|Baseline|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
630993|NCT02531646|B2|Baseline|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
630994|NCT02531646|B1|Baseline|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
630995|NCT02531646|P3|Participant Flow|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
630996|NCT02531646|P2|Participant Flow|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
630997|NCT02531646|P1|Participant Flow|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
630998|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
630999|NCT02531646|O1|Outcome|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631000|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631001|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631002|NCT02531646|O1|Outcome|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631003|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631004|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631028|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
631029|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
640258|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
631005|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631006|NCT02531646|O1|Outcome|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631007|NCT02531646|E3|Reported Event|Predicate & Invest. DT - Phantom Images|"Radiation - Eleven (11) phantoms of various anatomy will be imaged with linear tomography (LT) as predicate and DT for investigational.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631008|NCT02531646|E2|Reported Event|Predicate & Invest. DT – Human Subjects|"Radiation - Fifteen to twenty (15-20) patients will receive a DR standard of care chest exam using the DRX Plus detector, and a DT exam. Each DT patient exam includes a scout image (chest PA) and a DT scan using the investigational DT SW. The DT scan is used by the DT console software to generate tomographic images.~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631009|NCT02531646|E1|Reported Event|Predicate & Invest. DE – Human Subjects|"Radiation -Thirty to forty (30-40) patients will receive a DR standard of care chest exam using the DRX Plus detector and a DE exam. Each DE patient exam includes high energy and low energy image exposures using the investigational device. These images are used by the DE console software to generate additional DE images (e.g. bone and soft tissue).~Radiation: Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure."
631010|NCT02531308|B1|Baseline|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
631011|NCT02531308|P1|Participant Flow|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
631012|NCT02531308|O1|Outcome|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study."
631013|NCT02531308|E1|Reported Event|R-CHOP With Metformin|"Rituximab 375 mg/m2 IV infusion Day 1 Cyclophosphamide 750 mg/m2 IV Day 1 Doxorubicin 50 mg/m2 IV Day 1 Vincristine 1.4 mg/m2 (2 mg cap) IV Day 1 Prednisone 100 mg PO Days 1-5 Pegfilgrastim 6 mg subcutaneous within 72 hours of cyclophosphomide Metformin 500 mg PO daily D 1-7, 500 mg twice daily D8-21, 850 mg twice daily D22 - 30days post study.~Cycles are 21 days. Above treatment given for 4 cycles, then restaging done. If complete response (CR) or partial response (PR), 2 more cycle given; stable disease (SD) or progressive disease (PD)- salvage therapy off study.~Metformin: Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.~Rituximab: monoclonal antibody against protein CD20~Cyclophosphamide: Interferes with DNA replication~Doxorubicin: anthracycline antitumor antibiotic~Vincristine: Inhibits cell mitosis causing cell death.~Prednisone: a synthetic cortic"
631014|NCT02530671|B3|Baseline|Total|Total of all reporting groups
631015|NCT02530671|B2|Baseline|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
631016|NCT02530671|B1|Baseline|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
631017|NCT02530671|P2|Participant Flow|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
631018|NCT02530671|P1|Participant Flow|Manual Toothbrush|"ADA (American Dental Association) reference manual toothbrush~Toothbrushing with manual toothbrush"
631019|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
631020|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
631021|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
631022|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
631023|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
631024|NCT02530671|O1|Outcome|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
631025|NCT02530671|O2|Outcome|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
631031|NCT02530671|E2|Reported Event|Power Toothbrush|"Multi-directional power toothbrush~Toothbrushing with power toothbrush"
631032|NCT02530671|E1|Reported Event|Manual Toothbrush|"ADA reference manual toothbrush~Toothbrushing with manual toothbrush"
631033|NCT02530450|B3|Baseline|Total|Total of all reporting groups
631034|NCT02530450|B2|Baseline|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631035|NCT02530450|B1|Baseline|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631036|NCT02530450|P2|Participant Flow|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631037|NCT02530450|P1|Participant Flow|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631038|NCT02530450|O2|Outcome|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631039|NCT02530450|O1|Outcome|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631040|NCT02530450|E2|Reported Event|Group 2|"Never blinded to continuous glucose monitoring data~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631041|NCT02530450|E1|Reported Event|Group 1|"Initially blinded to continuous glucose monitoring data after 1st use Not blinded to continuous glucose monitoring data after 2nd and 3rd use~continuous glucose monitoring (CGM): All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points."
631042|NCT02529995|B3|Baseline|Total|Total of all reporting groups
631043|NCT02529995|B2|Baseline|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631044|NCT02529995|B1|Baseline|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631045|NCT02529995|P2|Participant Flow|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631046|NCT02529995|P1|Participant Flow|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631047|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631048|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631049|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631050|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631051|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631052|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631053|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631054|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631055|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631056|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631057|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631058|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631059|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631060|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631061|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631062|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631063|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631064|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631065|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631066|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631067|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631068|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631069|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631070|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631071|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631072|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631073|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631074|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631075|NCT02529995|O2|Outcome|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631076|NCT02529995|O1|Outcome|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631077|NCT02529995|E2|Reported Event|AZD9291 80mg|Single oral dose of AZD9291 80mg on Cycle 0 Day 1
631078|NCT02529995|E1|Reported Event|AZD9291 40mg|Single oral dose of AZD9291 40mg on Cycle 0 Day 1
631079|NCT02528721|B3|Baseline|Total|Total of all reporting groups
631080|NCT02528721|B2|Baseline|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631081|NCT02528721|B1|Baseline|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631082|NCT02528721|P2|Participant Flow|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631083|NCT02528721|P1|Participant Flow|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631084|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631085|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631086|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631087|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631088|NCT02528721|O2|Outcome|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631089|NCT02528721|O1|Outcome|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631090|NCT02528721|E2|Reported Event|Post Therapy Subjects|"Patients wishing to confirm eradication of initially diagnosed H.pylori infection that are after treatment within the last 6 months~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631091|NCT02528721|E1|Reported Event|Initial Diagnosis Subjects|"Patients with clinical indication for H.pylori infection~Dual Mode BreathID Hp System: The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device"
631092|NCT02528331|B1|Baseline|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
631093|NCT02528331|P1|Participant Flow|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
631094|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
631095|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
631096|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
631097|NCT02528331|O1|Outcome|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
631098|NCT02528331|E1|Reported Event|rTMS and Cognitive Behavior Therapy|"Transcranial magnetic stimulation~Cognitive behavioral therapy"
631099|NCT02528097|B3|Baseline|Total|Total of all reporting groups
631100|NCT02528097|B2|Baseline|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
631101|NCT02528097|B1|Baseline|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
631102|NCT02528097|P2|Participant Flow|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
631103|NCT02528097|P1|Participant Flow|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
631369|NCT02518048|E1|Reported Event|All Subjects|All subjects received both medication and reporting is on the entire population.
632729|NCT02484729|P1|Participant Flow|Part A- Placebo|Subjects received matching placebo under fasted conditions
631104|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
631105|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
631106|NCT02528097|O2|Outcome|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
631107|NCT02528097|O1|Outcome|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
631108|NCT02528097|E2|Reported Event|Experimental|"Albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline). If albumin not administered at 48 hours, BUN and Cr will be monitored daily for 72 hours and will be administered if Cr > 1.0 or BUN or Cr are above baseline.~Experimental: 25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)"
631109|NCT02528097|E1|Reported Event|Active Comparator Standard Care|"albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)~Standard Care: Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)"
631110|NCT02527161|B1|Baseline|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631111|NCT02527161|P1|Participant Flow|ShapeMatch® Cutting Guides With Triathlon®|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631112|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631113|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631114|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631115|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631116|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631117|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631118|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631119|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631120|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631121|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631122|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631123|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631124|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631125|NCT02527161|O1|Outcome|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631126|NCT02527161|E1|Reported Event|ShapeMatch Cutting Guides With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System using the ShapeMatch® Cutting Guides.
631127|NCT02527148|B3|Baseline|Total|Total of all reporting groups
631128|NCT02527148|B2|Baseline|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631129|NCT02527148|B1|Baseline|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631130|NCT02527148|P2|Participant Flow|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631131|NCT02527148|P1|Participant Flow|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631132|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631133|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631134|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631135|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631136|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631137|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631138|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631139|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631140|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631141|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631142|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631143|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631144|NCT02527148|O2|Outcome|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631145|NCT02527148|O1|Outcome|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631146|NCT02527148|E2|Reported Event|Stryker Precision Knee Navigation|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System guided by Stryker Precision Knee Navigation.
631147|NCT02527148|E1|Reported Event|OtisMed® ShapeMatch® With Triathlon|Participants who underwent Total Knee Replacement (TKR) with the Stryker Triathlon® Total Knee System and OtisMed® ShapeMatch® Technology.
631148|NCT02526550|B1|Baseline|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
631149|NCT02526550|P1|Participant Flow|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
631150|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
631151|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
631152|NCT02526550|O1|Outcome|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
631174|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631370|NCT02516306|B3|Baseline|Total|Total of all reporting groups
631153|NCT02526550|E1|Reported Event|Imojev|"Live attenuated chimeric Japanese Encephalitis vaccine, 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh and Simultaneous administration of Inactivated Hepatitis A vaccine, 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh~Live attenuated chimeric Japanese Encephalitis vaccine: 0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh~Inactivated Hepatitis A vaccine: 0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh"
631154|NCT02525536|B4|Baseline|Total|Total of all reporting groups
631155|NCT02525536|B3|Baseline|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631156|NCT02525536|B2|Baseline|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631157|NCT02525536|B1|Baseline|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631158|NCT02525536|P3|Participant Flow|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631159|NCT02525536|P2|Participant Flow|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631160|NCT02525536|P1|Participant Flow|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631161|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631162|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631163|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631164|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631165|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631166|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631167|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631168|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631169|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631170|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631171|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631172|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631173|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631175|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631176|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631177|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631178|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631179|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631180|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631181|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631182|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631183|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631184|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631185|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631186|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631187|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631188|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631189|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631190|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631191|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631192|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631193|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631194|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631195|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
632717|NCT02484729|B3|Baseline|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
631196|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631197|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631198|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631199|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631200|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631201|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631202|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631203|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631204|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631205|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631206|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631207|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631208|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631209|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631210|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631211|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631212|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631213|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631214|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631215|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631216|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
632718|NCT02484729|B2|Baseline|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
631217|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631218|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631219|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631220|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631221|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631222|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631223|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631224|NCT02525536|O3|Outcome|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631225|NCT02525536|O2|Outcome|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631226|NCT02525536|O1|Outcome|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631227|NCT02525536|E3|Reported Event|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631228|NCT02525536|E2|Reported Event|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631229|NCT02525536|E1|Reported Event|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, 60-minute infusion, intravenously once weekly on Days 1, 8, 15 and 22 and thereafter once weekly starting from Day 36 (Week 6) until intolerance to investigational product, progressive disease, consent withdrawn, or lost to follow-up (up to approximately 249 weeks).
631230|NCT02524665|B1|Baseline|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631231|NCT02524665|P1|Participant Flow|MAXCLARITY II + Murad|MaxClarity II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MaxClarity II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631232|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631233|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
631234|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631235|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
631236|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631237|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
631238|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631239|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
631240|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631241|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
631242|NCT02524665|O2|Outcome|Murad|Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. It was applied topically to 1 side of face BD for 8 weeks. In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631243|NCT02524665|O1|Outcome|MAXCLARITY II|MAXCLARITY II was a 2.5% BPO foam cleanser and foam treatment, 0.5% SA toner foam. It was applied topically to 1 side of face BD for 8 weeks. Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in AM and toner foam in PM.
631244|NCT02524665|E1|Reported Event|MAXCLARITY II + Murad|MAXCLARITY II was a 2.5 percent (%) benzoyl peroxide (BPO) foam cleanser and foam treatment, 0.5% salicylic acid (SA) toner foam. Murad clarifying cleanser was a 1.5% SA plus exfoliating acne treatment gel (1% SA) and skin perfecting lotion. Both treatments were applied topically to 1 side of face twice daily (BD) for 8 weeks. MAXCLARITY II application: Participants washed the assigned side of face with the foam cleanser, patted dry twice and then applied foam treatment in ante meridiem (AM) and toner foam in post meridiem (PM). Murad application: In first week of treatment, participants washed the assigned side of face with the clarifying cleanser, patted dry twice and applied acne treatment gel, then applied skin perfecting lotion in AM and skin perfecting lotion only in PM. During weeks 2-8, in AM and PM, participants washed assigned side of the face with clarifying cleanser, patted dry, applied acne treatment gel, then applied skin perfecting lotion.
631245|NCT02524561|B4|Baseline|Total|Total of all reporting groups
631246|NCT02524561|B3|Baseline|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
631247|NCT02524561|B2|Baseline|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
631248|NCT02524561|B1|Baseline|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
631249|NCT02524561|P3|Participant Flow|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
631269|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631250|NCT02524561|P2|Participant Flow|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
631251|NCT02524561|P1|Participant Flow|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
631252|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
631253|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
631254|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
631255|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
631256|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
631257|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
631258|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
631259|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
631260|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
631261|NCT02524561|O3|Outcome|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
631262|NCT02524561|O2|Outcome|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
631263|NCT02524561|O1|Outcome|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
631264|NCT02524561|E3|Reported Event|Placebo|"Placebo tablet, placebo patch, placebo progesterone~Placebo tablet: Placebo tablet~Placebo patch: placebo patch~Placebo progesterone: placebo progesterone"
631265|NCT02524561|E2|Reported Event|Estradiol Patch, Active Progesterone|"Transdermal estradiol, 50 mcg/day, placebo tablet, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Estradiol patch: Climara 50 mcg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo tablet: Placebo tablet"
631266|NCT02524561|E1|Reported Event|CEE Pill, Active Progesterone|"Conjugated equine estrogens 0.45 mg/day, placebo patch, Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~CEE pill: Conjugated equine estrogens 0.45 mg/day~Active Progesterone: Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime~Placebo patch: placebo patch"
631267|NCT02524418|B1|Baseline|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631268|NCT02524418|P1|Participant Flow|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
640259|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
631270|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631271|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631272|NCT02524418|O2|Outcome|Pancreatoscopy|Subject who had a Pancreatoscopy as part of their ERCP
631273|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631274|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631275|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631276|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631277|NCT02524418|O1|Outcome|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631278|NCT02524418|O2|Outcome|Pancreatoscopy|These are the subjects who had evaluation of their pancreas ducts during the Spyglass ERCP
631279|NCT02524418|O1|Outcome|Cholangioscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631280|NCT02524418|E1|Reported Event|Cholangiopancreatoscopy|"A standard of care Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) will be performed using the Spyglass DS. The clinical outcomes will be collected and analyzed.~Cholangiopancreatoscopy: An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed."
631281|NCT02522624|B3|Baseline|Total|Total of all reporting groups
631282|NCT02522624|B2|Baseline|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631283|NCT02522624|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631284|NCT02522624|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631285|NCT02522624|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631286|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631287|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631288|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631289|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631290|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631291|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631292|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631293|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631333|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631294|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631295|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631296|NCT02522624|O2|Outcome|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631297|NCT02522624|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631298|NCT02522624|E2|Reported Event|Control|Participants randomized to the control group will receive usual care. They will be directed to the healthcare.gov website and asked to follow the prompts to view and select (if applicable) a health insurance plan.
631299|NCT02522624|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to participants randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care."
631300|NCT02520414|B1|Baseline|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
631301|NCT02520414|P1|Participant Flow|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
631302|NCT02520414|O1|Outcome|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
631303|NCT02520414|E1|Reported Event|Symphion®|"Patients treated in-office with Symphion® Bipolar Hysteroscopic Tissue Resection System.~Symphion® Bipolar Hysteroscopic Tissue Resection System"
631304|NCT02519855|B3|Baseline|Total|Total of all reporting groups
631305|NCT02519855|B2|Baseline|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631306|NCT02519855|B1|Baseline|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631307|NCT02519855|P2|Participant Flow|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631308|NCT02519855|P1|Participant Flow|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631309|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631310|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631311|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631312|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631313|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631314|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631315|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631316|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631317|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631318|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631319|NCT02519855|O2|Outcome|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631320|NCT02519855|O1|Outcome|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631321|NCT02519855|E2|Reported Event|Nonconcomitant Vaccination|Influenza vaccine and placebo to ZOSTAVAX™ on Day 1, ZOSTAVAX™ at Week 4
631322|NCT02519855|E1|Reported Event|Concomitant Vaccination|ZOSTAVAX™ concomitantly with influenza vaccine on Day 1, placebo to ZOSTAVAX™ at Week 4
631323|NCT02519595|B4|Baseline|Total|Total of all reporting groups
631324|NCT02519595|B3|Baseline|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631325|NCT02519595|B2|Baseline|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631326|NCT02519595|B1|Baseline|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631327|NCT02519595|P3|Participant Flow|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631328|NCT02519595|P2|Participant Flow|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631329|NCT02519595|P1|Participant Flow|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631330|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631331|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631332|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631334|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631335|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631336|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631337|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631338|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631339|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631340|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631341|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631342|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631343|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631344|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631345|NCT02519595|O3|Outcome|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631346|NCT02519595|O2|Outcome|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631347|NCT02519595|O1|Outcome|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631348|NCT02519595|E3|Reported Event|Ketamine IV 2 mg/kg|"Intervention: A blinded dose of 2 mg/kg IV ketamine is administered to patients~Ketamine IV 2mg/kg: Intervention: Ketamine IV 2 mg/kg"
631349|NCT02519595|E2|Reported Event|Ketamine IV 1.5 mg/kg|"Intervention: A blinded dose of 1.5mg/kg IV ketamine is administered to patients~Ketamine IV 1.5mg/kg: Intervention: Ketamine IV 1.5 mg/kg"
631350|NCT02519595|E1|Reported Event|Ketamine IV 1 mg/kg|"Intervention: A blinded dose of 1mg/kg IV ketamine is administered to patients~Ketamine IV 1mg/kg: Intervention: Ketamine IV 1mg/kg"
631351|NCT02519387|B1|Baseline|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631352|NCT02519387|P1|Participant Flow|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631353|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631354|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631355|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631356|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631357|NCT02519387|O1|Outcome|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631358|NCT02519387|E1|Reported Event|Buprenorphine Transdermal Patch|"Buprenorphrine transdermal patch 5mg/10mg, every 7 days, for 3 months~Buprenorphine Transdermal Patch"
631359|NCT02518048|B1|Baseline|All Study Participants|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam~Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
631360|NCT02518048|P1|Participant Flow|LEO 90100 Aerosol Foam; Betesil® 2.25 mg|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam~Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
631361|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
631362|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
631363|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
631364|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
631365|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
631366|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
631367|NCT02518048|O2|Outcome|Betesil® 2.25 mg|"Betamethasone (as valerate). Each 7.5 cm x 10 cm medicated plaster contains: 2.250 mg of betamethasone valerate (corresponding to 1.845 mg of betamethasone)~Betesil® 2.25 mg"
631368|NCT02518048|O1|Outcome|LEO 90100 Aerosol Foam|"Calcipotriol (as monohydrate) 50 mcg/g and betamethasone (as dipropionate) 0.5 mg/g (LEO 90100 Aerosol foam)~LEO 90100 Aerosol foam"
640260|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
631371|NCT02516306|B2|Baseline|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
631372|NCT02516306|B1|Baseline|EV06 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop in one eye twice per day for 7 days; Period 2 (Day 8 - 91) one drop in both eyes twice per day for 84 days.
631373|NCT02516306|P2|Participant Flow|Placebo|Placebo Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye. Day 8 - 91 one drop administered twice per day in both eyes.
631374|NCT02516306|P1|Participant Flow|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Day 1 - 7 one drop twice per day in one eye; Day 8 - 91 one drop twice per day in both eyes.
631375|NCT02516306|O2|Outcome|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
631376|NCT02516306|O1|Outcome|EVO6 Ophthalmic Solution|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day in one eye; Period 2 (Day 8 - 91) one drop twice per day in both eyes.
631377|NCT02516306|E2|Reported Event|Placebo|Placebo Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
631378|NCT02516306|E1|Reported Event|EVO6|EV06 Ophthalmic Solution: Period 1 (Day 1 - 7) one drop twice per day to one eye; Period 2 (Day 8 - 91) one drop twice per day to both eyes.
631379|NCT02516163|B1|Baseline|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
631380|NCT02516163|P1|Participant Flow|Shapematch Cutting Guides|The ShapeMatch® Cutting Guides are patient-specific surgical instruments to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.They are single use only. Participants undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology is implemented in which the position of the femoral and tibial cutting guides is measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and instruments. No post-operative evaluations will be undertaken as part of this sub-study.
631381|NCT02516163|O1|Outcome|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only."
631382|NCT02516163|E1|Reported Event|Shapematch Cutting Guides|"The ShapeMatch® Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of knee arthroplasty components intra-operatively and in guiding the marking of bone before cutting.~They are intended for single use only.~Shapematch Cutting Guides: Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system instruments. No post-operative evaluations will be undertaken as part of this sub-study"
631383|NCT02516098|B3|Baseline|Total|Total of all reporting groups
631384|NCT02516098|B2|Baseline|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
631385|NCT02516098|B1|Baseline|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
631386|NCT02516098|P2|Participant Flow|T-REF|"The subjects received test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days followed by the reference treatment (REF) which was 20 mg of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
631387|NCT02516098|P1|Participant Flow|REF-T|"The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) followed by a washout period of 7 to 14 days followed by the test treatment (T) which was 20 mg of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) followed by a washout period of 7 to 14 days.~All medications were administered as a single oral dose in the fasted state via a sugar coated tablet."
631388|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
631389|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
631390|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
631391|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
631617|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631392|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
631393|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
631394|NCT02516098|O2|Outcome|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
631395|NCT02516098|O1|Outcome|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
631396|NCT02516098|E2|Reported Event|Buscapina® (T)|The subjects received the test treatment (T) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscapina®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet
631397|NCT02516098|E1|Reported Event|Buscopan® (REF)|The subjects received the reference treatment (REF) which was 20 milligram (mg) of hyoscine butylbromide (trade name: Buscopan®, 2*10mg) which was administered as a single oral dose in the fasted state via a sugar coated tablet.
631398|NCT02515994|B3|Baseline|Total|Total of all reporting groups
631399|NCT02515994|B2|Baseline|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
631400|NCT02515994|B1|Baseline|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
631401|NCT02515994|P2|Participant Flow|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
631402|NCT02515994|P1|Participant Flow|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
631403|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
631404|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
631405|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
631406|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
631407|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
631408|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
631409|NCT02515994|O2|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens throughout the entire study.
631410|NCT02515994|O1|Outcome|Senofilcon C|Subjects that wore the senofilcon C lens throughout the entire study.
631411|NCT02515994|E2|Reported Event|Comfilcon A|Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
631412|NCT02515994|E1|Reported Event|Senofilcon C|Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.
631413|NCT02515279|B1|Baseline|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
631414|NCT02515279|P1|Participant Flow|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
631415|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
631416|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
631417|NCT02515279|O1|Outcome|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
631418|NCT02515279|E1|Reported Event|Participants With Hepatitis C|All participants were treated with Peginterferon alfa-2a+Ribavirin (Pegasys/Copegus) according to the summary of product characteristics and to the investigator’s discretion. The daily recommended dose for Pegasys, for the treatment of chronic Hepatitis C, was 180 micrograms once weekly by subcutaneous administration. Copegus was administered orally in doses according to the physician’s decision (depending on the participant’s weight and genotype). All participants were observed for 12 months.
631419|NCT02513095|B3|Baseline|Total|Total of all reporting groups
631420|NCT02513095|B2|Baseline|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
632719|NCT02484729|B1|Baseline|Part A- Placebo|Subjects received matching placebo under fasted conditions
631421|NCT02513095|B1|Baseline|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
631422|NCT02513095|P2|Participant Flow|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
631423|NCT02513095|P1|Participant Flow|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
631424|NCT02513095|O2|Outcome|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
631425|NCT02513095|O1|Outcome|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
631426|NCT02513095|E2|Reported Event|Standard of Care Only (SOC)|Standard of Care (SOC) treatment only, consisting of body cooling and supportive measures implemented immediately.
631427|NCT02513095|E1|Reported Event|Ryanodex|"Ryanodex (dantrolene sodium) for injectable suspension administered as an IV bolus, in addition to standard of care (SOC) treatment.~Dantrolene sodium for injectable suspension: Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg."
631428|NCT02512900|B3|Baseline|TOTAL|Total of all reporting groups
631429|NCT02512900|B2|Baseline|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631430|NCT02512900|B1|Baseline|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631431|NCT02512900|P2|Participant Flow|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631432|NCT02512900|P1|Participant Flow|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631433|NCT02512900|O1|Outcome|MEDI9929|On Day 1, a single dose of MEDI9929 was administered subcutaneously to participants, aged 12 to 17 years, inclusive.
631434|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631435|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631436|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631437|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631438|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631439|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631440|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631441|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631442|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631443|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631444|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631445|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631446|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631447|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631448|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631449|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631450|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631451|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631452|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631453|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631454|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631455|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631456|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631457|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631458|NCT02512900|O2|Outcome|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631459|NCT02512900|O1|Outcome|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631460|NCT02512900|E2|Reported Event|Cohort 2|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631461|NCT02512900|E1|Reported Event|Cohort 1|On Day 1, a single dose of MEDI9929 was administered subcutaneously to all participants.
631462|NCT02512783|B3|Baseline|Total|Total of all reporting groups
631463|NCT02512783|B2|Baseline|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631464|NCT02512783|B1|Baseline|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631465|NCT02512783|P2|Participant Flow|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631466|NCT02512783|P1|Participant Flow|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631467|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631468|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631469|NCT02512783|O2|Outcome|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631470|NCT02512783|O1|Outcome|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631471|NCT02512783|E2|Reported Event|Normal Saline|"Administration of 1ml of pre-treatment normal saline immediately prior to propofol induction.~Normal Saline: Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631472|NCT02512783|E1|Reported Event|Lidocaine|"Administration of 1ml of pre-treatment 1% lidocaine immediately prior to propofol induction.~Lidocaine: Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation~Propofol: Intravenous administration of propofol according to standard care to sedate patient."
631473|NCT02512679|B1|Baseline|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631474|NCT02512679|P2|Participant Flow|Cyclophosphamide Dose Level 2|"De-escalation of Cyclophosphamide given by Intravenous (IV) at a total dose of 70 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 75 mg/kg, to be divided into two doses of one 35 mg/kg dose per day, for 2 days. After ten patients the de-escalation will begin if the stopping rule is not met."
631475|NCT02512679|P1|Participant Flow|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631476|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631477|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631478|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631479|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631480|NCT02512679|O1|Outcome|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631481|NCT02512679|E1|Reported Event|Cyclophosphamide Dose Level 1|"Cyclophosphamide given by Intravenous (IV) at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level.~Drug to be given in combination of Busulfan, Campath and Fludarabine~Cyclophosphamide Dose Level 1: given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met."
631482|NCT02512224|B3|Baseline|Total|Total of all reporting groups
631483|NCT02512224|B2|Baseline|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631484|NCT02512224|B1|Baseline|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631485|NCT02512224|P2|Participant Flow|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631486|NCT02512224|P1|Participant Flow|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631487|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631488|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631489|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631490|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631491|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631492|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631493|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631494|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631495|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631496|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631497|NCT02512224|O2|Outcome|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631498|NCT02512224|O1|Outcome|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631499|NCT02512224|E2|Reported Event|Enteral Nutrition|"investigators selected participants aged 20 years or older who had undergone enteral nutrition by percutaneous endoscopic gastrostomy, percutaneous transesophageal gastrotubing, or ileostomy between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631500|NCT02512224|E1|Reported Event|Parenteral Nutrition|"investigators selected participants aged 20 years or older who had undergoneparenteral nutrition by central venous port insertion between April 1, 2012, and March 31, 2013.~Parenteral nutrition and Enteral nutrition: Participants are retrospectively selected with propensity score matching"
631501|NCT02511782|B4|Baseline|Total|Total of all reporting groups
631529|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631530|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631564|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631502|NCT02511782|B3|Baseline|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631503|NCT02511782|B2|Baseline|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631504|NCT02511782|B1|Baseline|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631505|NCT02511782|P3|Participant Flow|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631506|NCT02511782|P2|Participant Flow|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631507|NCT02511782|P1|Participant Flow|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631508|NCT02511782|O2|Outcome|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631509|NCT02511782|O1|Outcome|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631510|NCT02511782|O3|Outcome|Chronic Graft Versus Host Disease|This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease.
631531|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631532|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631511|NCT02511782|O2|Outcome|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631512|NCT02511782|O1|Outcome|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631513|NCT02511782|E3|Reported Event|Healthy Controls|"This study arm includes healthy age matched controls as comparisons to study participants who develop graft versus host disease. These controls may be either healthy age matched siblings of patients who develop acute graft versus host disease or healthy age matched siblings of patients that are seen in the bone marrow transplant, oncology, or hematology clinics. A one-time single skin cell sample will be collected using a D-SQUAME Skin Sampling Disc. Blood samples will not be collected from the healthy controls.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631514|NCT02511782|E2|Reported Event|Chronic Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop chronic graft versus host disease. Skin cell samples will be collected weekly for 4 weeks using the D-SQUAME Skin Sampling Discs. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631515|NCT02511782|E1|Reported Event|Acute Graft Versus Host Disease|"This study arm includes patients who undergo allogeneic hematopoietic cell transplantation at CCHMC and develop acute graft versus host disease. Skin cell samples will be collected using the D-SQUAME Skin Sampling Discs. The first baseline skin sample will be obtained prior to the preparative regimen for stem cell transplant. Samples will be collected weekly after stem cell infusion until 8 weeks, if acute GVHD does not develop. If acute GVHD does develop, weekly samples will continue to be collected until resolution of acute GVHD or development of chronic GVHD, whichever occurs first. Blood samples will be collected at these same time points.~D-SQUAME Skin Sampling Discs: A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application."
631516|NCT02510820|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear either the Synergi/comfilcon A or Biotrue/comfilcon A combination for one month, then cross over to the alternative combination.
631517|NCT02510820|P2|Participant Flow|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|Participants were randomized to wear Biotrue/comfilcon A combination for one month, then cross over to the alternative Synergi/comfilcon A combination.
631518|NCT02510820|P1|Participant Flow|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|Participants were randomized to wear Synergi/comfilcon A combination for one month, then cross over to the alternative Biotrue/comfilcon A combination.
631519|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631520|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631521|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631522|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631523|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631524|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631525|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631526|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631527|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631528|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631533|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631534|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631535|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631536|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631537|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631538|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631539|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631540|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631541|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631542|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631543|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631544|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631545|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631546|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631547|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631548|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631549|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631550|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens Synergi: Multipurpose solution"
631551|NCT02510820|O2|Outcome|Biotrue / Comfilcon A|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution"
631552|NCT02510820|O1|Outcome|Synergi / Comfilcon A|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution"
631553|NCT02510820|E2|Reported Event|Biotrue/Comfilcon A Combo, Then Synergi/Comfilcon A Combo|"Participants were randomized to wear the Biotrue / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Biotrue: Multipurpose solution~Synergi: Multipurpose solution"
631554|NCT02510820|E1|Reported Event|Synergi/Comfilcon A Combo, Then Biotrue/Comfilcon A Combo|"Participants were randomized to wear the Synergi / comfilcon A combination for one month during the cross over study.~comfilcon A: soft contact lens~Synergi: Multipurpose solution~Biotrue: Multipurpose solution"
631555|NCT02507752|B1|Baseline|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631556|NCT02507752|P1|Participant Flow|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631557|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631558|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631559|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631560|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631561|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631562|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631563|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
633977|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
631565|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631566|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631567|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631568|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631569|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631570|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631571|NCT02507752|O1|Outcome|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631572|NCT02507752|E1|Reported Event|Rituximab|Participants with rheumatoid arthritis, who were treated with rituximab according to standard medical practice, were included in this cohort.
631573|NCT02507375|B3|Baseline|Total|Total of all reporting groups
631574|NCT02507375|B2|Baseline|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
631575|NCT02507375|B1|Baseline|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
631576|NCT02507375|P2|Participant Flow|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
631577|NCT02507375|P1|Participant Flow|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
631578|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
631579|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
631580|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
631581|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
631582|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
631583|NCT02507375|O1|Outcome|Pertuzumab + Erlotinib|In cycle 1 day 1 pertuzumab was administered at a dose of 840mg over 60 min. All patients included in the pharmacokinetic (PK) analyses of pertuzumab (cycle 2 only), tolerated the infusion in cycle 1 as the cycle 2 dose of 420mg was administered over 30 mins in all but one patient, who was dosed over 33 minutes. Serum samples for pertuzumab were taken for pharmacokinetic analysis on day 1 of cycle 2, 1 hour pre-dose and 0.5, 1.5, 4, 8, 24, 168, 336 and 504 hours after the start of the infusion. Four participants in each cohort (8 total) had adequate data to be included in the PK analyses.
631584|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
631616|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
640261|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
631585|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
631586|NCT02507375|O3|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
631587|NCT02507375|O2|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
631588|NCT02507375|O1|Outcome|Total Population|Erlotinib + pertuzumab
631589|NCT02507375|O2|Outcome|Erlotinib 150 mg + Pertuzumab 420 mg|Participants received erlotinib 150 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously.
631590|NCT02507375|O1|Outcome|Erlotinib 100 mg + Pertuzumab 420 mg|Participants received erlotinib 100 mg orally once daily plus pertuzumab 420 mg intravenously every 3 weeks until disease progression, unacceptable toxicity, or the participant withdrew from the study. The first dose of pertuzumab was a loading dose of 840 mg intravenously
631591|NCT02507375|E2|Reported Event|Cohort 2|Erlotinib 150 mg + pertuzumab 420 mg
631592|NCT02507375|E1|Reported Event|Cohort 1|Erlotinib 100 mg + pertuzumab 420 mg
631593|NCT02506881|B5|Baseline|Total|Total of all reporting groups
631594|NCT02506881|B4|Baseline|Aranesp → BCD-066 - Intravenous|Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
631595|NCT02506881|B3|Baseline|BCD-066 → Aranesp - Intravenous|Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
631596|NCT02506881|B2|Baseline|Aranesp → BCD-066 - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.
631597|NCT02506881|B1|Baseline|BCD-066 → Aranesp - Subcutaneous|Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.
631598|NCT02506881|P4|Participant Flow|Aranesp → BCD-066 - Intravenous|"Volunteers in this group initially will receive a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
631599|NCT02506881|P3|Participant Flow|BCD-066 → Aranesp - Intravenous|"Volunteers in this group initially will receive a single iv injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single iv injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
631600|NCT02506881|P2|Participant Flow|Aranesp → BCD-066 - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
631601|NCT02506881|P1|Participant Flow|BCD-066 → Aranesp - Subcutaneous|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-066 (darbepoetin alfa) at a dose of 1 µg/kg (on Day 1) and then, after at least 25 days, a single sc injection of the reference drug Aranesp® (darbepoetin alfa) at a dose of 1 µg/kg.~Darbepoetin alfa"
631602|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631603|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631604|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631605|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631606|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631607|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631608|NCT02506881|O2|Outcome|Aranesp® - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631609|NCT02506881|O1|Outcome|BCD-066 - Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631610|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631611|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631612|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631613|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631614|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631615|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631618|NCT02506881|O4|Outcome|Aranesp® - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631619|NCT02506881|O3|Outcome|BCD-066 - Intravenous|Pharmacodynamics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631620|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.
631621|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|Pharmacodynamics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.
631622|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
631623|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 72 hours is reported."
631624|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
631625|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~Cmax of darbepoetin alfa 0 to 336 hours is reported."
631626|NCT02506881|O4|Outcome|Aranesp® - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
631627|NCT02506881|O3|Outcome|BCD-066 - Intravenous|"Pharmacokinetics of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 72 hours is reported."
631628|NCT02506881|O2|Outcome|Aranesp® Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
631629|NCT02506881|O1|Outcome|BCD-066 Subcutaneous|"Pharmacokinetics of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg was analysed.~AUC of darbepoetin alfa 0 to 336 hours is reported."
631630|NCT02506881|E4|Reported Event|Aranesp® - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of Aranesp® in a dose of 1 µg/kg are presented.
631631|NCT02506881|E3|Reported Event|BCD-066 - Intravenous|Safety parameters of darbepoetin alfa after intravenous injection of BCD-066 in a dose of 1 µg/kg are presented.
631632|NCT02506881|E2|Reported Event|Aranesp® Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of Aranesp® in a dose of 1 µg/kg are presented.
631633|NCT02506881|E1|Reported Event|BCD-066 Subcutaneous|Safety parameters of darbepoetin alfa after subcutaneous injection of BCD-066 in a dose of 1 µg/kg are presented.
631634|NCT02506309|B3|Baseline|Total|Total of all reporting groups
631635|NCT02506309|B2|Baseline|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631636|NCT02506309|B1|Baseline|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631637|NCT02506309|P2|Participant Flow|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631638|NCT02506309|P1|Participant Flow|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631639|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631640|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631641|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631642|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631643|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631644|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631645|NCT02506309|O2|Outcome|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631646|NCT02506309|O1|Outcome|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631647|NCT02506309|E2|Reported Event|TOT Trans Obturato Tape/Sling|"TOT - inside-out trans-obturator tape/sling Trans-obturator slings (TOT) now represent a gold standard in the treatment of female stress urinary incontinence (SUI).~TOT - inside-out trans-obturator tape/sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631648|NCT02506309|E1|Reported Event|SIS Single Incision Sling|"SIS - Innovative fixation single incision sling A third generation of the Mid-urethral slings inserted through a SIS single incision sling (SIS) to treat female stress urinary incontinence (SUI).~SIS - Innovative fixation single incision sling: Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)"
631649|NCT02506257|B5|Baseline|Total|Total of all reporting groups
631650|NCT02506257|B4|Baseline|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631651|NCT02506257|B3|Baseline|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631652|NCT02506257|B2|Baseline|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631653|NCT02506257|B1|Baseline|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631654|NCT02506257|P4|Participant Flow|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631655|NCT02506257|P3|Participant Flow|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631656|NCT02506257|P2|Participant Flow|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631657|NCT02506257|P1|Participant Flow|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631658|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631659|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631660|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631661|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631662|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631663|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631664|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631665|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631666|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631692|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631667|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631668|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631669|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631670|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631671|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631672|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631673|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631674|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631675|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631676|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631677|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631678|NCT02506257|O4|Outcome|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631679|NCT02506257|O3|Outcome|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631680|NCT02506257|O2|Outcome|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631681|NCT02506257|O1|Outcome|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631682|NCT02506257|E4|Reported Event|PHMB Vehicle|"PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~PHMB Vehicle: PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631683|NCT02506257|E3|Reported Event|0.08% PHMB|"0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.08% PHMB: 0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631684|NCT02506257|E2|Reported Event|0.06% PHMB|"0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.06% PHMB: 0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631685|NCT02506257|E1|Reported Event|0.04% PHMB|"0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days~0.04% PHMB: 0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days"
631686|NCT02504775|B1|Baseline|Overall Participants|Total number of participants who were randomized and received treatment.
631687|NCT02504775|P2|Participant Flow|Mejoral® 500 Tablets (Test), Then Tylenol® Caplets (Reference)|Participants first received one tablet of Mejoral® Tablets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Tylenol® 500 Caplets (500 mg of paracetamol), orally with 250 ml of water at room temperature, in a single dose, under minimum 10 h of fasting.
631688|NCT02504775|P1|Participant Flow|Tylenol® Caplets (Reference), Then Mejoral® 500 Tablets (Test)|Participants first received one tablet of Tylenol® Caplets [500 milligram (mg) of paracetamol], orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting. After a washout period of 72 h, they then received one tablet of Mejoral® 500 tablets (500 mg of paracetamol), orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h of fasting.
631689|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631690|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631691|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631744|NCT02503865|O3|Outcome|Healthy People|64 healthy people
640262|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
631693|NCT02504775|O2|Outcome|Mejoral® 500 Tablets|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631694|NCT02504775|O1|Outcome|Tylenol® Caplets|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631695|NCT02504775|O2|Outcome|Mejoral® 500 Tablets (Test)|Participants were orally administered with one tablet of Mejoral® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631696|NCT02504775|O1|Outcome|Tylenol® Caplets (Reference)|Participants were orally administered with one caplet of Tylenol® Caplets (500 mg of paracetamol) with 250 mL of water at room temperature, in a single dose, after minimum 10 h of fasting
631697|NCT02504775|E2|Reported Event|Mejoral® 500 Tablets|Participants will first receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
631698|NCT02504775|E1|Reported Event|Tylenol® Caplets|Participants will first receive one tablet [500 milligram (mg) of paracetamol] of Tylenol® Caplets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting. After a washout period of 72 h, they then will receive one tablet (500 mg of paracetamol) of Mejoral® 500 tablets, orally with 250 mL of water at room temperature, in a single dose, under minimum 10 h fasting.
631699|NCT02504502|B3|Baseline|Total|Total of all reporting groups
631700|NCT02504502|B2|Baseline|Enhanced Genomic Report|"Those resulting in variants of significance will received routine clinical care and access to the enhanced genomic lab report.~Enhanced Genomic Report: Routine clinical care vs. enhanced genomic report"
631701|NCT02504502|B1|Baseline|Routine Clinical Care|"Those resulting in variants of significance will receive routine clinical care and receive the enhanced genomic report in 6 months.~Routine Clinical Care: Participants will receive routine clinical care. After 6 months the participants will also receive the enhanced genomic report."
631702|NCT02504502|P2|Participant Flow|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
631703|NCT02504502|P1|Participant Flow|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
631704|NCT02504502|O2|Outcome|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
631705|NCT02504502|O1|Outcome|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
631706|NCT02504502|E2|Reported Event|Routine Clinical Care Plus Enhanced Genomic Report|Routine clinical care and access to the enhanced genomic lab report upon completion of the baseline survey. Participants in this arm will receive only one survey at 3 months post enhanced report.
631707|NCT02504502|E1|Reported Event|Routine Clinical Care First, Then Enhanced Report|Participants will receive routine clinical care with a copy of their standard laboratory report. After completion of the 3 month survey, participants will receive the enhanced report, followed by another survey 3 months after receiving the enhanced report.
631708|NCT02504320|B5|Baseline|Total|Total of all reporting groups
631709|NCT02504320|B4|Baseline|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
631710|NCT02504320|B3|Baseline|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
631711|NCT02504320|B2|Baseline|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
631712|NCT02504320|B1|Baseline|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
631713|NCT02504320|P4|Participant Flow|Treatment Sequence BCAD|Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 1 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3 orally, once on Day 1 of Period 2 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 3 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 4 (D).
631745|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
632723|NCT02484729|P7|Participant Flow|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
631714|NCT02504320|P3|Participant Flow|Treatment Sequence CDBA|Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 1 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F4 orally, once on Day 1 of Period 2 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 3 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1, orally, once on Day 1 of Period 4 (A).
631715|NCT02504320|P2|Participant Flow|Treatment Sequence DACB|Febuxostat XR 80 mg capsule F4, orally, once on Day 1 of Period 1 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F1 orally, once on Day 1 of Period 2 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F3, orally, once on Day 1 of Period 3 (C), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule F2, orally, once on Day 1 of Period 4 (B).
631716|NCT02504320|P1|Participant Flow|Treatment Sequence ABDC|Febuxostat XR 80 mg capsule Formulation 1 (F1), orally, once on Day 1 of Period 1 (A), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 2 (F2), orally, once on Day 1 of Period 2 (B), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 4 (F4), orally, once on Day 1 of Period 3 (D), followed by at least a 7-day washout period, followed by Febuxostat XR 80 mg capsule Formulation 3 (F3), orally, once on Day 1 of Period 4 (C).
631717|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
631718|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
631719|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
631720|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
631721|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
631722|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
631723|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
631724|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
631725|NCT02504320|O4|Outcome|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
631726|NCT02504320|O3|Outcome|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
631727|NCT02504320|O2|Outcome|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
631728|NCT02504320|O1|Outcome|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
631729|NCT02504320|E4|Reported Event|Regimen D: Febuxostat XR 80 mg Formulation 4|Febuxostat XR 80 mg capsule formulation 4 (F4), orally, once on Day 1 of periods 1, 2, 3 or 4.
631730|NCT02504320|E3|Reported Event|Regimen C: Febuxostat XR 80 mg Formulation 3|Febuxostat XR 80 mg capsule formulation 3 (F3), orally, once on Day 1 of periods 1, 2, 3 or 4.
631731|NCT02504320|E2|Reported Event|Regimen B: Febuxostat XR 80 mg Formulation 2|Febuxostat XR 80 mg capsule formulation 2 (F2), orally, once on Day 1 of periods 1, 2, 3 or 4.
631732|NCT02504320|E1|Reported Event|Regimen A: Febuxostat XR 80 mg Formulation 1|Febuxostat XR 80 mg capsule formulation 1 (F1), orally, once on Day 1 of periods 1, 2, 3 or 4.
631733|NCT02503982|B1|Baseline|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
631734|NCT02503982|P1|Participant Flow|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
631735|NCT02503982|O1|Outcome|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
631736|NCT02503982|E1|Reported Event|Solid Organ Transplanted Children|"Intervention: treatment with prophylactic oral valganciclovir with a fixed dose of 17 mg/kg once daily for prophylaxis. Max dose was 900 mg.~prophylactic Valganciclovir: The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis. Max dose was 900 mg."
631737|NCT02503865|B4|Baseline|Total|Total of all reporting groups
631738|NCT02503865|B3|Baseline|Healthy People|64 healthy people
631739|NCT02503865|B2|Baseline|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
631740|NCT02503865|B1|Baseline|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631741|NCT02503865|P3|Participant Flow|Healthy People|64 healthy people
631742|NCT02503865|P2|Participant Flow|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
631743|NCT02503865|P1|Participant Flow|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631746|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631747|NCT02503865|O3|Outcome|Healthy People|64 healthy people
631748|NCT02503865|O2|Outcome|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
631749|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631750|NCT02503865|O3|Outcome|Healthy People|64 healthy people
631751|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
631752|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631753|NCT02503865|O3|Outcome|Healthy People|64 healthy people
631754|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
631755|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631756|NCT02503865|O3|Outcome|Healthy People|64 healthy people
631757|NCT02503865|O2|Outcome|"Analimentary Detoxication Weight Loss"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
631758|NCT02503865|O1|Outcome|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631759|NCT02503865|E3|Reported Event|Healthy People|64 healthy people
631760|NCT02503865|E2|Reported Event|"Analimentary Detoxication"|"Dietary Supplement - Vegetable and salt diet. Weight loss program Analimentary detoxication~Analimentary detoxication: Vegetable and salt diet"
631761|NCT02503865|E1|Reported Event|Conventional Patient Group|"Xenical (Orlistat) 120 mg a day for 6 months with antidiabetes, antihypertensive therapy~Xenical (Orlistat): Xenical (Orlistat) - 120 mg/day, Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day"
631762|NCT02503254|B3|Baseline|Total|Total of all reporting groups
631763|NCT02503254|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
631764|NCT02503254|B1|Baseline|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
631765|NCT02503254|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
631766|NCT02503254|P1|Participant Flow|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
631767|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
631768|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
631769|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
631770|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
631771|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
631772|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
631773|NCT02503254|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
631774|NCT02503254|O1|Outcome|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
631775|NCT02503254|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.0 at Admission (Day -3) but were not randomized
631776|NCT02503254|E2|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
631777|NCT02503254|E1|Reported Event|CHTP 1.0|Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
631778|NCT02503215|B1|Baseline|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
631779|NCT02503215|P1|Participant Flow|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
631780|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
631781|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
631782|NCT02503215|O1|Outcome|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
631783|NCT02503215|E1|Reported Event|Compression Stockings|"Patients wore graduated lower limb compression stockings for a week. The investigators evaluated if such procedure caused better sleep performance~Compression Stockings: To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea"
631784|NCT02502487|B4|Baseline|Total|Total of all reporting groups
631785|NCT02502487|B3|Baseline|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631786|NCT02502487|B2|Baseline|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631787|NCT02502487|B1|Baseline|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631788|NCT02502487|P3|Participant Flow|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631789|NCT02502487|P2|Participant Flow|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631790|NCT02502487|P1|Participant Flow|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631791|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631792|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631793|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631794|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631795|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631796|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631797|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631798|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631799|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631800|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631801|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
634446|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
631802|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631803|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631804|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631805|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631806|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631807|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631808|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631809|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631810|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631811|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631812|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631813|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631814|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631815|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631816|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631817|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631818|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631819|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631820|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631821|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
640263|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
631822|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631823|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631824|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631825|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631826|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631827|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631828|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631829|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631830|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631831|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631832|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631833|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631834|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631835|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631836|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631837|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631838|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631839|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631840|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631841|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
634447|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
631842|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631843|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631844|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631845|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631846|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631847|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631848|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631849|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631850|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631851|NCT02502487|O3|Outcome|Combination Group|"Dorsal penile nerve block with ropivacaine and tetracaine gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis~Tetracaine: 1% Tetracaine gel instilled into urethra"
631852|NCT02502487|O2|Outcome|Dorsal Penile Nerve Block Group|"Dorsal penile nerve block with ropivacaine and plain lubricating gel into urethra before rigid cystoscopy~Dorsal Penile Nerve Block: Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis~Ropivacaine: 0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis"
631853|NCT02502487|O1|Outcome|Tetracaine Gel Group|"Dorsal penile nerve block with saline and tetracaine gel into urethra before rigid cystoscopy~Tetracaine: 1% Tetracaine gel instilled into urethra"
631854|NCT02502487|E3|Reported Event|Combination Group|DPNB with ropivacaine plus tetracaine gel
631855|NCT02502487|E2|Reported Event|DPNB Group|DPNB with ropivacaine plus plain lubricant
631856|NCT02502487|E1|Reported Event|Tetracaine Group|tetracaine gel plus DPNB with saline
631857|NCT02502734|B1|Baseline|Fluticasone Furoate and Placebo in Any of the Two Sequences|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 2. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
631858|NCT02502734|P2|Participant Flow|Fluticasone Furoate Followed by Placebo|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 2 participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 1 followed by oral inhalation of placebo, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
631859|NCT02502734|P1|Participant Flow|Placebo Followed by Fluticasone Furoate|Participants received oral inhalation of 50 microgram (mcg) fluticasone furoate (FF) once daily (OD) or placebo for 14 days in either of the treatment periods in a two-way crossover design. Sequence 1 participants received oral inhalation of placebo OD for 14 days +/- 4 days in Treatment Period 1, followed by oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days in Treatment Period 2. The two treatment periods were separated by a two-week wash-out period. Additionally, all participants were provided a salbutamol inhaler for symptomatic relief of asthma symptoms during the 2-week run-in, washout, and treatment periods as needed.
631860|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
631861|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
635555|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
631862|NCT02502734|O2|Outcome|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2.
631863|NCT02502734|O1|Outcome|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2.
631864|NCT02502734|E2|Reported Event|Fluticasone Furoate|Participants received oral inhalation of FF 50 mcg, OD for 14 days +/- 4 days during Period 1 or Period 2
631865|NCT02502734|E1|Reported Event|Placebo|Participants received oral inhalation of placebo OD for 14 days +/- 4 days during Period 1 or Period 2
631866|NCT02500836|B4|Baseline|Total|Total of all reporting groups
631867|NCT02500836|B3|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
631868|NCT02500836|B2|Baseline|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
631869|NCT02500836|B1|Baseline|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
631870|NCT02500836|P3|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
631871|NCT02500836|P2|Participant Flow|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
631872|NCT02500836|P1|Participant Flow|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
631873|NCT02500836|O2|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
631874|NCT02500836|O1|Outcome|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
631875|NCT02500836|O2|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
631876|NCT02500836|O1|Outcome|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
631877|NCT02500836|E3|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
631878|NCT02500836|E2|Reported Event|Cocaine HCI 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
631879|NCT02500836|E1|Reported Event|Cocaine HCI 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
631880|NCT02500758|B3|Baseline|Total|Total of all reporting groups
631881|NCT02500758|B2|Baseline|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
631882|NCT02500758|B1|Baseline|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
631883|NCT02500758|P2|Participant Flow|Chlorhexidine Digluconate Then Parachlorometaxylenol|"Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).~After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol."
631884|NCT02500758|P1|Participant Flow|Parachlorometaxylenol Then Clorhexidine Digluconate|Participants first scrubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with parachlorometaxylenol After a washout period of 1 week, to allow reconstruction of the normal skin flora, they then scubbed their hands, for 2 minutes, using a sterile disponsable surgical scrub with chlorhexidine digluconato (matching parachlorometaxylenol).
631885|NCT02500758|O2|Outcome|Chlorhexidine Digluconate|"Change in bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
631886|NCT02500758|O1|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
635556|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
631887|NCT02500758|O2|Outcome|Chlorhexidine Digluconate|"Change in bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
631888|NCT02500758|O1|Outcome|Parachlorometaxylenol|"Change in bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard"
631889|NCT02500758|E2|Reported Event|Chlorhexidine Digluconate|"Reducing bacterial load after preoperative surgical scrubbing using 4% chlorhexidine digluconate. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
631890|NCT02500758|E1|Reported Event|Parachlorometaxylenol|"Reducing bacterial load after preoperative surgical scrubbing using 3% parachlorometaxylenol. Both hands have been prepared by preparatory handwash.~Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.~Preparatory handwash follows the UNE-EN 12791 standard."
631891|NCT02500537|B3|Baseline|Total|Total of all reporting groups
631892|NCT02500537|B2|Baseline|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631893|NCT02500537|B1|Baseline|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631894|NCT02500537|P2|Participant Flow|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631895|NCT02500537|P1|Participant Flow|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631896|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631897|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631898|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631899|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631900|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
632271|NCT02493036|O2|Outcome|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
631901|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631902|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631903|NCT02500537|O1|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631904|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631905|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631906|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631907|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631908|NCT02500537|O2|Outcome|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631909|NCT02500537|O1|Outcome|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631910|NCT02500537|E2|Reported Event|Thoracic Procedures|"Thoracic procedures may include, but are not limited to wedge resection and lobectomy, and may include video assisted thoracic surgery (VATS) or open procedures~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631911|NCT02500537|E1|Reported Event|Abdominal Procedures|"Abdominal procedures may include, but are not limited to, laparoscopic sleeve gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LRYGB), and biliopancreatic diversion, as well as hepatic and pancreatic resection~Endo GIA™ Reinforced Reload with Tri-Staple™ Technology: Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)"
631912|NCT02500368|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear silicone hydrogel lens (test) or enfilcon A lens (control) for 1 week during the cross over study.
631913|NCT02500368|P2|Participant Flow|Enfilcon A Lens (Control), Then Silicone Hydrogel Lens (Test)|"Participants were randomized to wear enfilcon A lens (control) for 1 week, then cross over to the silicone hydrogel lens (test).~enfilcon A lens (control): contact lens~silicone hydrogel lens (test): contact lens"
631914|NCT02500368|P1|Participant Flow|Silicone Hydrogel Lens (Test), Then Enfilcon A Lens (Control)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week, then cross over to the enfilcon A lens (control).~silicone hydrogel lens (test): contact lens~enfilcon A lens (control): contact lens"
631915|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631916|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631917|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631918|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631919|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631920|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631921|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631922|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631923|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631924|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631925|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631926|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631927|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631928|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631929|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631930|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631931|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631932|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631933|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631934|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631935|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631936|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631937|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631938|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631939|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631940|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631941|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631942|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631943|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631944|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631945|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631946|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631947|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631948|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631949|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631950|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631951|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631952|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631953|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631954|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631955|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631956|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631957|NCT02500368|O2|Outcome|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631958|NCT02500368|O1|Outcome|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631959|NCT02500368|E2|Reported Event|Enfilcon A Lens (Control)|"Participants were randomized to wear enfilcon A lens (control) for 1 week during the cross over study.~enfilcon A lens (control): contact lens"
631960|NCT02500368|E1|Reported Event|Silicone Hydrogel Lens (Test)|"Participants were randomized to wear silicone hydrogel lens (test) for 1 week during the cross over study.~silicone hydrogel lens (test): contact lens"
631961|NCT02500056|B3|Baseline|Total|Total of all reporting groups
631962|NCT02500056|B2|Baseline|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
631963|NCT02500056|B1|Baseline|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
631964|NCT02500056|P2|Participant Flow|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
631965|NCT02500056|P1|Participant Flow|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
631966|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
631967|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
631968|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
631969|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
631970|NCT02500056|O2|Outcome|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
631971|NCT02500056|O1|Outcome|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
631972|NCT02500056|E2|Reported Event|UM Group|"Ultrapro mesh~Ultrapro mesh: Lichtenstein hernioplasty"
631973|NCT02500056|E1|Reported Event|OM Group|"Optilene LP mesh~Optilene LP mesh: Lichtenstein hernioplasty"
631974|NCT02499692|B1|Baseline|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631975|NCT02499692|P1|Participant Flow|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631976|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631977|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631978|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631979|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631980|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631981|NCT02499692|O1|Outcome|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631982|NCT02499692|E1|Reported Event|SYNERGYTM Coronary Stent System|"Device:SYNERGY MONORAIL Everolimus-Eluting Platinum Chromium Coronary Stent System~SYNERGYTM Coronary Stent System: SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System"
631983|NCT02499575|B3|Baseline|Total|Total of all reporting groups
631984|NCT02499575|B2|Baseline|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
631985|NCT02499575|B1|Baseline|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
631986|NCT02499575|P2|Participant Flow|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
631987|NCT02499575|P1|Participant Flow|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
631988|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
631989|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
631990|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
631991|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
631992|NCT02499575|O2|Outcome|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
631993|NCT02499575|O1|Outcome|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
631994|NCT02499575|E2|Reported Event|Regional Block Plus Exparel|"Group B patients will receive the standard of care pre-operative adductor and popliteal block as described (40 mL/200 mg of 0.5% ropivacaine) in addition to a postoperative pericapsular injection of Exparel using 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl), per the same total dose as provided in manufacturer recommendations.~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine~Exparel: 106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)"
631995|NCT02499575|E1|Reported Event|Regional Block|"Group A patients will receive only a pre-operative adductor canal block with 10 mL 0.5% ropivacaine plus a popliteal block with 30 mL 0.5% ropivacaine (total block 40 mL/200 mg).~0.5% ropivacaine: Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine"
631996|NCT02498821|B3|Baseline|Total|Total of all reporting groups
631997|NCT02498821|B2|Baseline|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
631998|NCT02498821|B1|Baseline|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
631999|NCT02498821|P2|Participant Flow|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® Tip Confirmation System (TCS) magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632000|NCT02498821|P1|Participant Flow|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632001|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632002|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632003|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632057|NCT02497235|B1|Baseline|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632299|NCT02492451|B4|Baseline|Total|Total of all reporting groups
632004|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632005|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632006|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632007|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632008|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632009|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632010|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632011|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632012|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632013|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632059|NCT02497235|P4|Participant Flow|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
640264|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
632014|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632015|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632016|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632017|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632018|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632019|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632020|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632021|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632022|NCT02498821|O2|Outcome|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632023|NCT02498821|O1|Outcome|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632060|NCT02497235|P3|Participant Flow|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
640265|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
632024|NCT02498821|E2|Reported Event|Sherlock 3CG® TCS|"Correct placement of the Peripherally Inserted Central Catheter (PICC)will be confirmed using Sherlock 3CG® TCS magnetic tracking PICC placement and ECG-based tip confirmation.~Sherlock 3CG® TCS: The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632025|NCT02498821|E1|Reported Event|Standard of Care (Chest X-ray)|"Correct placement of the Peripherally Inserted Central Catheter (PICC) will be confirmed using standard of care (Chest X-ray).~X-ray: A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.~Peripherally Inserted Central Catheter (PICC): A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)"
632026|NCT02498678|B3|Baseline|Total|Total of all reporting groups
632027|NCT02498678|B2|Baseline|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632028|NCT02498678|B1|Baseline|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632029|NCT02498678|P2|Participant Flow|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632030|NCT02498678|P1|Participant Flow|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632031|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632032|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632033|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632034|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632035|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632058|NCT02497235|P5|Participant Flow|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
640266|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
632036|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632037|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632038|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632039|NCT02498678|O2|Outcome|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632040|NCT02498678|O1|Outcome|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632041|NCT02498678|E2|Reported Event|Tetanus Group|"After verifying the absence of sevoflurane through the gas analyzer, a 50-Hz tetanic stimulation will be applied for 5 s and followed after 1 min by TOF stimulation every 15 s. After 1 minute (min) calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.~Tetanus: tetanic electric stimulation"
632042|NCT02498678|E1|Reported Event|Control Group|After verifying the absence of sevoflurane through the gas analyzer, TOF monitor mode starts with stimuli every 12 to 15 seconds. After 1 minute (min) stimulation, calibration and supramaximal stimulation will be ensured by the built-in calibration function (CAL 2) of the TOF-Watch®. The stability of the response will be documented by at least 2 to 5 min [< 5% variation in the first response (T1) in the TOF]. Monitoring of neuromuscular junction will be held until recovery of the TOF ratio to 0.9 (90%), an expected average of 60 minutes.
632043|NCT02498522|B3|Baseline|Total|Total of all reporting groups
632044|NCT02498522|B2|Baseline|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632045|NCT02498522|B1|Baseline|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632046|NCT02498522|P2|Participant Flow|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632047|NCT02498522|P1|Participant Flow|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632048|NCT02498522|O2|Outcome|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632049|NCT02498522|O1|Outcome|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632050|NCT02498522|E2|Reported Event|Control Arm|"83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632051|NCT02498522|E1|Reported Event|Metformin Arm|"83 patients will continue metformin until end of 1st trimester (14 weeks gestation)~Metformin: 83 patients will continue metformin until end of 1st trimester"
632052|NCT02497235|B6|Baseline|Total|Total of all reporting groups
632053|NCT02497235|B5|Baseline|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
632054|NCT02497235|B4|Baseline|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632055|NCT02497235|B3|Baseline|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632056|NCT02497235|B2|Baseline|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632300|NCT02492451|B3|Baseline|Control Group|Only intrauterine insemination
632061|NCT02497235|P2|Participant Flow|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632062|NCT02497235|P1|Participant Flow|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632063|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
632064|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632065|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632066|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632067|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632068|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
632069|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632070|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632071|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632072|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632073|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
632074|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632075|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632076|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632077|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632078|NCT02497235|O1|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants.
632079|NCT02497235|O5|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
632080|NCT02497235|O4|Outcome|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632081|NCT02497235|O3|Outcome|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632082|NCT02497235|O2|Outcome|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at Baseline, 2 hours and 24 hours post-TAK-935 dose.
632083|NCT02497235|O1|Outcome|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632084|NCT02497235|O1|Outcome|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at Baseline, 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants.
632085|NCT02497235|E6|Reported Event|TAK-935 600 mg|TAK-935 600 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to first PET imaging at 45 minutes and 10 hours post-TAK-935 dose for the first 2 enrolled participants and at 2 hours and 24 hours post-TAK-935 dose for the participant enrolled later.
632724|NCT02484729|P6|Participant Flow|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632086|NCT02497235|E5|Reported Event|TAK-935 300 mg|TAK-935 300 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632087|NCT02497235|E4|Reported Event|TAK-935 200 mg|TAK-935 200 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632088|NCT02497235|E3|Reported Event|TAK-935 100 mg|TAK-935 100 mg, solution, orally, once on Day 1 and up to 370 MBq (10mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632089|NCT02497235|E2|Reported Event|TAK-935 50 mg|TAK-935 50 mg, solution, orally, once on Day 1 and up to 370 MBq (10 mCi) of [18F]MNI-792 with a mass of up to 5 mcg, injection, intravenously, prior to PET imaging at 2 hours and 24 hours post-TAK-935 dose.
632090|NCT02497235|E1|Reported Event|Baseline [18F]MNI-792|[18F]MNI-792 up to 370 MBq (10mCi) with a mass of up to 5 mcg, injection, intravenously, prior to Positron Emission Tomography (PET) imaging at Baseline.
632091|NCT02496533|B3|Baseline|Total|Total of all reporting groups
632092|NCT02496533|B2|Baseline|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
632093|NCT02496533|B1|Baseline|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
632094|NCT02496533|P2|Participant Flow|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
632095|NCT02496533|P1|Participant Flow|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
632096|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
632097|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
632098|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
632099|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
632100|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
632101|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
632102|NCT02496533|O2|Outcome|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
632103|NCT02496533|O1|Outcome|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
632104|NCT02496533|E2|Reported Event|No Massage|Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before and after imaging. The anxiety VAS will be repeated after the imaging procedure. Subjects in this arm will not receive the hand massage prior to the imaging procedure.
632128|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632105|NCT02496533|E1|Reported Event|Hand Massage|"Subjects in this arm will complete rate their anxiety by visual analog scale (VAS). Blood pressure, pulse and respiration will be recorded before massage, after massage but before imaging, and after imaging.The subjects will receive hand massage prior to the imaging procedure. The anxiety VAS will be repeated after the imaging procedure.~Hand Massage: The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff."
632106|NCT02496221|B1|Baseline|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
632107|NCT02496221|P2|Participant Flow|Placebo Followed by Albiglutide 50 mg|Participants received Placebo in Treatment Period 1 and Albiglutide 50 mg in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
632108|NCT02496221|P1|Participant Flow|Albiglutide 50 mg Followed by Placebo|Participants received Albiglutide 50 milligrams (mg) in Treatment Period 1 and Placebo in Treatment Period 2, each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in each period.
632109|NCT02496221|O3|Outcome|Albiglutide 50 mg and Placebo|Participants were assessed at Follow-up after 28 days following the last dose of albiglutide or placebo.
632110|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632111|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632112|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632113|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632114|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632115|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632116|NCT02496221|O1|Outcome|Albiglutide 50 mg and Placebo|In a total of two treatment periods, participants received Albiglutide 50 mg (A) and Placebo (P) (in a sequence of either A-P or P-A), each administered subcutaneously as a single dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of a cholecystokinin (sincalide) in each period.
632117|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632118|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632119|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632120|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632121|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632122|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632123|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632124|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632125|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632126|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632127|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632266|NCT02493036|B1|Baseline|42-mg SYN-010/42-mg SYN-010|42-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
632129|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632130|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632131|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632132|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632133|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632134|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632135|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632136|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632137|NCT02496221|O2|Outcome|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632138|NCT02496221|O1|Outcome|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632139|NCT02496221|E2|Reported Event|Albiglutide 50 mg|In one of the two treatment periods, participants received Albiglutide 50 mg as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632140|NCT02496221|E1|Reported Event|Placebo|In one of the two treatment periods, participants received Placebo as a single subcutaneous dose, using a fully disposable pen injector system. Participants also received an intravenous infusion of cholecystokinin (sincalide) in this period.
632141|NCT02496000|B4|Baseline|Total|Total of all reporting groups
632142|NCT02496000|B3|Baseline|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
632143|NCT02496000|B2|Baseline|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
632144|NCT02496000|B1|Baseline|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
632145|NCT02496000|P3|Participant Flow|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
632146|NCT02496000|P2|Participant Flow|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
632147|NCT02496000|P1|Participant Flow|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
632148|NCT02496000|O4|Outcome|ORMD-0801 Doses 1 and 2 Combined|The combined measurements of dose 1 and dose 2, in units of mg/dL
632149|NCT02496000|O3|Outcome|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
632150|NCT02496000|O2|Outcome|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
632151|NCT02496000|O1|Outcome|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
632152|NCT02496000|E3|Reported Event|ORMD-0801 Dose 2 = 1.5 * Dose 1|"three identical capsules, as follows: capsule #1, 2, and 3: one half of Dose 1~ORMD-0801: Oral Insulin"
632153|NCT02496000|E2|Reported Event|ORMD-0801 Dose 1|"three identical capsules, as follows: capsule #1: one half of Dose 1 capsule #2: one half of Dose 1 capsule #3: placebo~ORMD-0801: Oral Insulin"
632154|NCT02496000|E1|Reported Event|Placebo Comparator|"three identical capsules containing placebo~Placebo Comparator: Placebo"
632155|NCT02495948|B1|Baseline|Overall|Lotrafilcon B and samfilcon A contact lenses worn during Period 1 and Period 2 in a crossover assignment, as randomized.
632156|NCT02495948|P2|Participant Flow|ULTRA Then AOA|Samfilcon A contact lenses worn first, followed by lotrafilcon B contact lenses. Each product worn bilaterally for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
632157|NCT02495948|P1|Participant Flow|AOA Then ULTRA|Lotrafilcon B contact lenses worn first, followed by samfilcon A contact lenses. Each product worn bilaterally (in both eyes) for a minimum of 5 days/week, 8 hours/day for 30 days in a daily wear modality.
632158|NCT02495948|O2|Outcome|ULTRA|Samfilcon A contact lenses worn during Period 1 or Period 2 for 30 days
632159|NCT02495948|O1|Outcome|AIR OPTIX AQUA (AOA)|Lotrafilcon B contact lenses worn during Period 1 or Period 2 for 30 days
632160|NCT02495948|E3|Reported Event|ULTRA|All subjects exposed to samfilcon A contact lenses during Period 1 or Period 2
632161|NCT02495948|E2|Reported Event|AIR OPTIX AQUA|All subjects exposed to lotrafilcon B contact lenses during Period 1 or Period 2
632162|NCT02495948|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
632267|NCT02493036|P3|Participant Flow|Placebo|Placebo
632163|NCT02495831|B1|Baseline|Intervention|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium 50 mg oral tablets, single dose and safinamide 200 mg oral tablets, single dose"
632164|NCT02495831|P2|Participant Flow|Safinamide + Diclofenac Sodium First, Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose Safinamide 200 mg oral tablets, single dose
632165|NCT02495831|P1|Participant Flow|Diclofenac Sodium First, Safinamide + Diclofenac Sodium Second|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
632166|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
632167|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
632168|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
632169|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
632170|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
632171|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
632172|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
632173|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
632174|NCT02495831|O2|Outcome|Diclofenac Sodium and Safinamide|"Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose~Diclofenac sodium and safinamide: Diclofenac 50 mg single dose and safinamide 200 mg single dose"
632175|NCT02495831|O1|Outcome|Diclofenac Sodium|"Diclofenac sodium 50 mg oral tablets, single dose~Diclofenac sodium: Diclofenac sodium 50 mg single dose"
632176|NCT02495831|E2|Reported Event|Diclofenac Sodium and Safinamide|Diclofenac sodium 50 mg oral tablets, single dose, and safinamide 200 mg oral tablets, single dose
632177|NCT02495831|E1|Reported Event|Diclofenac Sodium|Diclofenac sodium 50 mg oral tablets, single dose
632178|NCT02495623|B4|Baseline|Total|Total of all reporting groups
632179|NCT02495623|B3|Baseline|Placebo|Placebo
632180|NCT02495623|B2|Baseline|High Dose|42 mg SYN-010
632181|NCT02495623|B1|Baseline|Low Dose|21 mg SYN-010
632182|NCT02495623|P3|Participant Flow|Placebo|Placebo
632183|NCT02495623|P2|Participant Flow|High Dose|42 mg SYN-010
632184|NCT02495623|P1|Participant Flow|Low Dose|21 mg SYN-010
632185|NCT02495623|O3|Outcome|Placebo|"Placebo~Placebo"
632186|NCT02495623|O2|Outcome|High Dose|"42 mg SYN-010~SYN-010 42 mg"
632187|NCT02495623|O1|Outcome|Low Dose|"21 mg SYN-010~SYN-010 21 mg"
632188|NCT02495623|E3|Reported Event|Placebo|"Placebo~Placebo"
632189|NCT02495623|E2|Reported Event|High Dose|"42 mg SYN-010~SYN-010 42 mg"
632190|NCT02495623|E1|Reported Event|Low Dose|"21 mg SYN-010~SYN-010 21 mg"
632191|NCT02493855|B4|Baseline|Total|Total of all reporting groups
632192|NCT02493855|B3|Baseline|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
632193|NCT02493855|B2|Baseline|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
632194|NCT02493855|B1|Baseline|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
632195|NCT02493855|P3|Participant Flow|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
632196|NCT02493855|P2|Participant Flow|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
632197|NCT02493855|P1|Participant Flow|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
632198|NCT02493855|O3|Outcome|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
632199|NCT02493855|O2|Outcome|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
632200|NCT02493855|O1|Outcome|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
632201|NCT02493855|E3|Reported Event|Arm C: Ribavirin Low-dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and 600 mg ribavirin once daily for 12 weeks.
632202|NCT02493855|E2|Reported Event|Arm B: Ribavirin Full Dose for 12 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) and weight-based ribavirin (1000 mg or 1200 mg split BID) for 12 weeks.
632268|NCT02493036|P2|Participant Flow|Low Dose SYN-010|21-mg SYN-010
632269|NCT02493036|P1|Participant Flow|High Dose SYN-010|42-mg SYN-010
632203|NCT02493855|E1|Reported Event|Arm A: Ribavirin Full Dose for Last 10 Weeks|Participants received ombitasvir/ABT-450/ritonavir 25 mg/150 mg/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) for 12 weeks and weight-based ribavirin (1000 mg or 1200 mg split BID) for the last 10 weeks.
632204|NCT02494596|B1|Baseline|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632205|NCT02494596|P3|Participant Flow|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632206|NCT02494596|P2|Participant Flow|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632207|NCT02494596|P1|Participant Flow|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 milligrams per square meter (mg/m^2) orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632208|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632209|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632210|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632211|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632212|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632213|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632214|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632215|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632216|NCT02494596|O1|Outcome|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632217|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632218|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632219|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632270|NCT02493036|O3|Outcome|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
632220|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632221|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632222|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632223|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825, 1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632224|NCT02494596|O3|Outcome|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632225|NCT02494596|O2|Outcome|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632226|NCT02494596|O1|Outcome|Capecitabine 825 Plus (+) Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg intravenous (IV) infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632227|NCT02494596|O1|Outcome|Capecitabine + Pertuzumab|Participants received a single dose of capecitabine either 825,1000 or 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632228|NCT02494596|E3|Reported Event|Capecitabine 1250 + Pertuzumab 1050|Participants received a single dose of capecitabine 1250 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632229|NCT02494596|E2|Reported Event|Capecitabine 1000 + Pertuzumab 1050|Participants received a single dose of capecitabine 1000 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632230|NCT02494596|E1|Reported Event|Capecitabine 825 + Pertuzumab 1050|Participants received a single dose of capecitabine 825 mg/m^2 orally on Day -7 and subsequently on Days 1 to 14 of each 3-week cycle administered twice daily. Participants also received pertuzumab on Day 1 of each 3-week cycle as a fixed-dose of 1050-mg IV infusion until progression of the disease, occurrence of unacceptable toxicity or withdrawal of consent.
632231|NCT02494440|B1|Baseline|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
632232|NCT02494440|P1|Participant Flow|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
632233|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
632234|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
632235|NCT02494440|O1|Outcome|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
632236|NCT02494440|E1|Reported Event|Pregnant Women at Third Trimester of Pregnancy|"Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were done for all cases for assessment of fetal femur length.~The estimation of gestational age by femur length by Two-Dimensional Ultrasound and Five-Dimensional Ultrasound were compared to gestational age calculated by accurate dates of the last menstrual period."
632237|NCT02494323|B1|Baseline|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
632238|NCT02494323|P1|Participant Flow|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
632239|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
632240|NCT02494323|O1|Outcome|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
632241|NCT02494323|E1|Reported Event|Functional Electrical Stimulation|"Dual channel stimulation of the peroneal nerve to improve dropfoot~Functional Electrical Stimulation: Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot"
632242|NCT02493127|B3|Baseline|Total|Total of all reporting groups
632243|NCT02493127|B2|Baseline|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
632244|NCT02493127|B1|Baseline|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
632245|NCT02493127|P2|Participant Flow|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
632246|NCT02493127|P1|Participant Flow|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
632247|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
632248|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
632249|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
632250|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
632251|NCT02493127|O2|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
632252|NCT02493127|O1|Outcome|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
632253|NCT02493127|O1|Outcome|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
632254|NCT02493127|O1|Outcome|Standard Pain Catastrophizing Scale (PCS)|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
632255|NCT02493127|E2|Reported Event|Positive PCS|"Grip strength measurements and completes positively adjusted PCS~Grip Strength: Research Assistant takes Grip Strength Measurements~Positively Adjusted PCS: Subject completes the positively-adjusted version of the PCS Questionnaire"
632256|NCT02493127|E1|Reported Event|Standard PCS|"Grip strength measurements and completes standard PCS~Standard PCS: Subject completes the standard version of the PCS Questionnaire~Grip Strength: Research Assistant takes Grip Strength Measurements"
632257|NCT02493088|B1|Baseline|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
632258|NCT02493088|P1|Participant Flow|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
632259|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
632260|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
632261|NCT02493088|O1|Outcome|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Antisocial personality recording of behavior and contextual elements: aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study"
632262|NCT02493088|E1|Reported Event|Antisocial Personality|"Individuals Diagnosed with Antisocial Personality Disorder~Aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder were recorded during the study.~Adverse events were not related to the study.~Recorded adverse events were situations where subjects were harmed and required medical intervention."
632263|NCT02493036|B4|Baseline|Total|Total of all reporting groups
632264|NCT02493036|B3|Baseline|Placebo/42-mg SYN-010|Placebo in study NCT02495623 followed by 42-mg SYN-010 in current study
632265|NCT02493036|B2|Baseline|21-mg SYN-010/42-mg SYN-010|21-mg SYN-010 in study NCT02495623 followed by 42-mg SYN-010 in current study
632272|NCT02493036|O1|Outcome|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
632273|NCT02493036|E3|Reported Event|Placebo/42-mg SYN-010|Subjects were on placebo in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
632274|NCT02493036|E2|Reported Event|21-mg SYN-010/42-mg SYN-010|Subjects were on 21 mg in the 4-week (double-blind) study and then received 42 mg in the 8-week extension study
632275|NCT02493036|E1|Reported Event|42-mg SYN-010/42-mg SYN-010|Subjects were on 42 mg in the 4-week (double-blind) study and were continued on 42 mg in the 8-week extension study
632276|NCT02492984|B3|Baseline|Total|Total of all reporting groups
632277|NCT02492984|B2|Baseline|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632278|NCT02492984|B1|Baseline|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632279|NCT02492984|P2|Participant Flow|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632280|NCT02492984|P1|Participant Flow|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632281|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632282|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632283|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632284|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632285|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632286|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632287|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632288|NCT02492984|O1|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632289|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632290|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632291|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632292|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632293|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632294|NCT02492984|O2|Outcome|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632295|NCT02492984|O1|Outcome|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632296|NCT02492984|E3|Reported Event|Total|Treatment Group Description TBD
632297|NCT02492984|E2|Reported Event|Surgical Prophylaxis Group|Participants were treated with intravenous infusions of Xyntha 500 IU/vial. The treatment duration for surgical prophylaxis was decided by the investigator depending on surgery nature and participant conditions.
632298|NCT02492984|E1|Reported Event|On-Demand Group|Participants were treated with intravenous infusions of Xyntha 500 International Unit (IU)/vial at a dose and frequency prescribed by the participant's treating physician in accordance with the China Xyntha Package Insert for approximately 6 months or approximately 50 exposure days (EDs).
632301|NCT02492451|B2|Baseline|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
632302|NCT02492451|B1|Baseline|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
632303|NCT02492451|P3|Participant Flow|Control Group|Only intrauterine insemination
632304|NCT02492451|P2|Participant Flow|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
632305|NCT02492451|P1|Participant Flow|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
632306|NCT02492451|O3|Outcome|Control Group|Only intrauterine insemination
632307|NCT02492451|O2|Outcome|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
632308|NCT02492451|O1|Outcome|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
632309|NCT02492451|E3|Reported Event|Control Group|Only intrauterine insemination
632310|NCT02492451|E2|Reported Event|Luteal Phase Support|"Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.~progesterone (Crinone® %8 vaginal progesterone gel): Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy."
632311|NCT02492451|E1|Reported Event|Endometrial Injury|"Endometrial injury in luteal phase of preceding IUI cycle~Endometrial Injury: Endometrial injury in luteal phase of preceding cycle by pipelle canula"
632312|NCT02492165|B5|Baseline|Total|Total of all reporting groups
632313|NCT02492165|B4|Baseline|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632314|NCT02492165|B3|Baseline|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632315|NCT02492165|B2|Baseline|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632316|NCT02492165|B1|Baseline|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632317|NCT02492165|P4|Participant Flow|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632318|NCT02492165|P3|Participant Flow|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632319|NCT02492165|P2|Participant Flow|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632320|NCT02492165|P1|Participant Flow|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632321|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632322|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632323|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632324|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632325|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632326|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632327|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632328|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632329|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632330|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632331|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632332|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632333|NCT02492165|O4|Outcome|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632334|NCT02492165|O3|Outcome|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632335|NCT02492165|O2|Outcome|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632336|NCT02492165|O1|Outcome|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632337|NCT02492165|E4|Reported Event|18 to 60 Years|Healthy participants aged 18 to 60 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632338|NCT02492165|E3|Reported Event|12 to 17 Years|Healthy participants aged 12 to 17 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632339|NCT02492165|E2|Reported Event|5 to 11 Years|Healthy participants aged 5 to 11 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632340|NCT02492165|E1|Reported Event|9 Months to 4 Years|Healthy participants aged 9 months to 4 years who received a single primary dose of a live attenuated Japanese Encephalitis Chimeric Virus Vaccine (IMOJEV®).
632341|NCT02491944|B1|Baseline|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632342|NCT02491944|P1|Participant Flow|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632343|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632344|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632345|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632346|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632347|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632348|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632349|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632350|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632351|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632352|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632353|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632354|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632355|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632356|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632357|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632358|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
640267|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
632359|NCT02491944|O1|Outcome|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632360|NCT02491944|E1|Reported Event|AZD9291 and [14C]AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 and a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
632361|NCT02491892|B3|Baseline|Total|Total of all reporting groups
632362|NCT02491892|B2|Baseline|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632363|NCT02491892|B1|Baseline|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632364|NCT02491892|P2|Participant Flow|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632365|NCT02491892|P1|Participant Flow|Pertuzumab 420 mg|Participants received a loading dose of 840 milligrams (mg) via intravenous (IV) infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632366|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632367|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632368|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632369|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632370|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632371|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632372|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632373|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632374|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632375|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632376|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632377|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632378|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632379|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632380|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632381|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632382|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632383|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632384|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632385|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632386|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632387|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632388|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632725|NCT02484729|P5|Participant Flow|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632389|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632390|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632391|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632392|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632393|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632394|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632395|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632396|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632397|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632398|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632399|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632400|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632401|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632402|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632403|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632404|NCT02491892|O2|Outcome|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632405|NCT02491892|O1|Outcome|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632406|NCT02491892|E2|Reported Event|Pertuzumab 1050 mg|Participants did not receive a loading dose, but received pertuzumab 1050 mg via IV infusion every 3 weeks until unacceptable toxicity or disease progression.
632407|NCT02491892|E1|Reported Event|Pertuzumab 420 mg|Participants received a loading dose of 840 mg via IV infusion at the first infusion of pertuzumab, followed by a maintenance dose of 420 mg every 3 weeks until unacceptable toxicity or disease progression.
632408|NCT02490670|B3|Baseline|Total|Total of all reporting groups
632409|NCT02490670|B2|Baseline|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
632410|NCT02490670|B1|Baseline|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
632411|NCT02490670|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).
632412|NCT02490670|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
632413|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
632414|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
632415|NCT02490670|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
632416|NCT02490670|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
632417|NCT02490670|E2|Reported Event|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods.
632418|NCT02490670|E1|Reported Event|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
632419|NCT02490475|B5|Baseline|Total|Total of all reporting groups
632487|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
632726|NCT02484729|P4|Participant Flow|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632420|NCT02490475|B4|Baseline|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632421|NCT02490475|B3|Baseline|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632422|NCT02490475|B2|Baseline|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632423|NCT02490475|B1|Baseline|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632424|NCT02490475|P4|Participant Flow|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632425|NCT02490475|P3|Participant Flow|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632426|NCT02490475|P2|Participant Flow|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632427|NCT02490475|P1|Participant Flow|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 milligrams per square meter (mg/m^2) docetaxel and 1050 mg of pertuzumab as an intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 hours (h) apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632428|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632429|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632430|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632431|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632488|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632489|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632432|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632433|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632434|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632435|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632436|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632437|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632438|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632439|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632440|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632441|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632442|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632443|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632490|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
632727|NCT02484729|P3|Participant Flow|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632444|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632445|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632446|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632447|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632448|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632449|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632450|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632451|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632452|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632453|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632454|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632455|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632491|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632492|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632456|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632457|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632458|NCT02490475|O4|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632459|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632460|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632461|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632462|NCT02490475|O6|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632463|NCT02490475|O5|Outcome|Docetaxel 100 Alone|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632464|NCT02490475|O4|Outcome|Docetaxel 75+ Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632465|NCT02490475|O3|Outcome|Docetaxel 75 Alone|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632466|NCT02490475|O2|Outcome|Docetaxel 60 + Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632467|NCT02490475|O1|Outcome|Docetaxel 60 Alone|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632493|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
632728|NCT02484729|P2|Participant Flow|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632468|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632469|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632470|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632471|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632472|NCT02490475|O4|Outcome|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632473|NCT02490475|O3|Outcome|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632474|NCT02490475|O2|Outcome|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632475|NCT02490475|O1|Outcome|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632476|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632477|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632478|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
632479|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632480|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632481|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
632482|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632483|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632484|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
632485|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632486|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632494|NCT02490475|O3|Outcome|Pertuzumab 420|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632495|NCT02490475|O2|Outcome|Pertuzumab 840|Participants received pertuzumab 840 mg by IV infusion over approximately 90 minutes in Cycle 1 followed by a three weekly dose (Cycle 2) of 420 mg by IV infusion over approximately 30 minutes.
632496|NCT02490475|O1|Outcome|Pertuzumab 1050|Participants received 1050 mg of pertuzumab in Cycle 1 Day 2 (24 h after the administration of docetaxel) as an IV infusion over approximately 90 minutes and in Cycle 2 on Day 1, (immediately before docetaxel) infused over 30 minutes.
632497|NCT02490475|O1|Outcome|Entire Study Population|Participants received escalating dose levels of combination of docetaxel and pertuzumab. Participants received docetaxel 60 mg/m^2 and pertuzumab 1050 mg at dose level 1, docetaxel 75 mg/m^2 and pertuzumab 1050 mg at dose level 2, docetaxel 75 mg/m^2 and pertuzumab 420 mg at dose level 3 or 100 mg/m^2 and pertuzumab 420 mg at dose level 4 until DLTs were observed.
632498|NCT02490475|E4|Reported Event|Docetaxel 100 + Pertuzumab 420|Participants received 100 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632499|NCT02490475|E3|Reported Event|Docetaxel 75 + Pertuzumab 420|Participants received 75 mg/m^2 docetaxel and 420 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 participants received a loading dose of 840 mg of pertuzumab as an IV infusion. Further in Cycle 1 Docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632500|NCT02490475|E2|Reported Event|Docetaxel 75 + Pertuzumab 1050|Participants received 75 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632501|NCT02490475|E1|Reported Event|Docetaxel 60 Plus (+) Pertuzumab 1050|Participants received 60 mg/m^2 docetaxel and 1050 mg of pertuzumab as an IV infusion every 3 weeks until disease progression, unacceptable toxicity, or consent withdrawal. In Cycle 1 docetaxel was administered on Day 1 and pertuzumab was administered at least 24 h apart on Day 2. Cycle 2 onwards pertuzumab was administered on Day 1 immediately followed by docetaxel. In addition all participants received 8 mg of dexamethasone or its equivalent as corticosteroid premedication.
632502|NCT02490293|B3|Baseline|Total|Total of all reporting groups
632503|NCT02490293|B2|Baseline|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
632504|NCT02490293|B1|Baseline|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
632505|NCT02490293|P2|Participant Flow|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
632506|NCT02490293|P1|Participant Flow|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
632507|NCT02490293|O2|Outcome|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
632508|NCT02490293|O1|Outcome|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
632720|NCT02484729|P10|Participant Flow|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632509|NCT02490293|O2|Outcome|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
632510|NCT02490293|O1|Outcome|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
632511|NCT02490293|E2|Reported Event|Group B (Placebo)|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days.~Placebo: During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
632512|NCT02490293|E1|Reported Event|Group A (Cephalosporin)|"During the period of hospitalization, intake of active drug ('pacetin', 2nd generation cephalosporin). 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days.~Cephalosporin: During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
632513|NCT02488980|B4|Baseline|Total|Total of all reporting groups
632514|NCT02488980|B3|Baseline|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
632515|NCT02488980|B2|Baseline|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
632516|NCT02488980|B1|Baseline|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
632517|NCT02488980|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
632518|NCT02488980|P2|Participant Flow|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
632519|NCT02488980|P1|Participant Flow|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
632520|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
632521|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
632522|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
632523|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
632524|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
632525|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
632526|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
632527|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
632528|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
632529|NCT02488980|O3|Outcome|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
632530|NCT02488980|O2|Outcome|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
632531|NCT02488980|O1|Outcome|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
632532|NCT02488980|E3|Reported Event|Mefloquine|"Mefloquine 250 mg for three days followed by Mefloquine 250 once a week for 24 weeks.~Mefloquine: Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks."
632533|NCT02488980|E2|Reported Event|Tafenoquine|"Tafenoquine 200 mg for three days followed by Tafenoquine 200 once a week for 24 weeks.~Tafenoquine: Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks."
632534|NCT02488980|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo for three days followed by placebo once a week for 24 weeks"
632535|NCT02488317|B3|Baseline|Total|Total of all reporting groups
632583|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
640268|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
632536|NCT02488317|B2|Baseline|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632537|NCT02488317|B1|Baseline|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632538|NCT02488317|P2|Participant Flow|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632539|NCT02488317|P1|Participant Flow|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632540|NCT02488317|O1|Outcome|Intervention Post-test|Intervention arm after reviewing the decision aid
632541|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632542|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632543|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632544|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632545|NCT02488317|O2|Outcome|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632546|NCT02488317|O1|Outcome|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632547|NCT02488317|O3|Outcome|Control|Control arm with no decision aid.
632548|NCT02488317|O2|Outcome|Intervention Post-test|Intervention arm responses after accessing the decision aid (N=63)
632549|NCT02488317|O1|Outcome|Intervention Pre-test|Intervention arm responses prior to accessing the decision aid (N=70)
632721|NCT02484729|P9|Participant Flow|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632550|NCT02488317|E2|Reported Event|Control Arm|"These patients will not receive the decision aid tool and will be asked to test their knowledge without it. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632551|NCT02488317|E1|Reported Event|Intervention Arm|"These patients will receive the decision aid tool. Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.~Decision Aid: Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid."
632552|NCT02488070|B1|Baseline|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
632553|NCT02488070|P1|Participant Flow|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Undergo PET/CT~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Given IV~Laboratory Biomarker Analysis: Correlative studies~Magnetic Resonance Imaging: Undergo PET/MRI~Positron Emission Tomography: Undergo PET/CT~Positron Emission Tomography: Undergo PET/MRI"
632554|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
632555|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Part of PET/CT scan~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope~Magnetic Resonance Imaging: Part of PET/MRI scan~Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
632556|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Part of PET/CT scan~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope~Magnetic Resonance Imaging: Part of PET/MRI scan~Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
632557|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|"Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.~Computed Tomography: Part of PET/CT scan~Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx): Intravenously-administered (IV) radioisotope~Magnetic Resonance Imaging: Part of PET/MRI scan~Positron Emission Tomography: Part of PET/CT and/or PET/MRI scans"
632558|NCT02488070|O1|Outcome|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
632559|NCT02488070|E1|Reported Event|Diagnostic (68Ga-PSMA PET/CT or PET/MRI)|Patients receive gallium Ga 68-labeled PSMA ligand Glu-urea-Lys(Ahx) IV and then undergo PET/CT or PET/MRI approximately 45-60 minutes later.
632560|NCT02488018|B1|Baseline|Provision of Experimental Honeys|Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule.
632561|NCT02488018|P1|Participant Flow|Honey Glycemic Index|"Study participants were given 25g available carbohydrate of reference glucose or monofloral honeys of Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense in 250 mL of water, after they have fasted for 11 hours overnight.~Monofloral honeys, namely: collected from honey productive areas; and reference glucose were used as a test food. 25g available carbohydrate of the test foods was provided to all ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
632562|NCT02488018|O1|Outcome|Provision of Experimental Honeys|"Monofloral honeys, namely: Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense collected from honey productive areas; and reference glucose were used as a test food.~25g available carbohydrate of the test foods was provided to ten human subjects after fasted for 11 hours overnight. After fasting blood sample was collected from the finger. Additional blood samples were taken at 15, 30, 45, 60, 90 and 120 minutes. Glucose concentration of blood samples was used to draw a two-hour blood glucose response curve. Area under curve (AUC) for test food and reference glucose was calculated by trapezoidal rule."
632563|NCT02488018|E1|Reported Event|Honey Glycemic Index|Study participants were given 25g available carbohydrate of reference glucose or honey in 250 mL of water, after they have fasted for 11 hours overnight.
632564|NCT02486952|B1|Baseline|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
632722|NCT02484729|P8|Participant Flow|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632565|NCT02486952|P1|Participant Flow|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for diffuse large B cell lymphoma (DLBCL), and received rituximab (MabThera) in combination with Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone (CHOP) or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
632566|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
632567|NCT02486952|O1|Outcome|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
632568|NCT02486952|E1|Reported Event|Diffuse Large B-Cell Lymphoma|Participants, who were not treated previously for DLBCL, and received rituximab in combination with CHOP or CHOP-like chemotherapy at the treating physician’s discretion and according to package labeling, within approved indication and local approval status of respective drugs. Participants were followed up for safety and efficacy in accordance with routine practice until progression of disease, unacceptable toxicity, withdrawal of consent or death from any reason.
632569|NCT02485483|B3|Baseline|Total|Total of all reporting groups
632570|NCT02485483|B2|Baseline|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
632571|NCT02485483|B1|Baseline|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632572|NCT02485483|P2|Participant Flow|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
632573|NCT02485483|P1|Participant Flow|VADERA I|Rheumatoid arthritis (RA) participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the World Health Organization Five Well-Being Index (WHO-5), Patient Health Questionnaire-9 (PHQ-9) and Beck Depression Inventory (2nd edition) (BDI-II) questionnaires and a subsequent structured interview using Montgomery-Åsberg Depression Rating Scale (MADRS) at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632574|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
632575|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
632576|NCT02485483|O1|Outcome|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
632577|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632578|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632579|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632580|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632581|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632582|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632602|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632584|NCT02485483|O1|Outcome|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632585|NCT02485483|E2|Reported Event|VADERA II|All RA participants who were able to complete the PHQ-9 and BDI-II questionnaires, and had been scheduled for a RA consultation at one of the participating clinics were eligible for participation.
632586|NCT02485483|E1|Reported Event|VADERA I|RA participants without a concurrent history of depression and who had not received psychotherapy, antidepressants, or inpatient psychiatric treatment in the 3 months before baseline (T0) were asked to complete the WHO-5, PHQ-9 and BDI-II questionnaires and a subsequent structured interview using MADRS at 2 time-points (T0 and T1 [12 ± 2 weeks]) with a 10-14 week interval between assessments.
632587|NCT02485158|B1|Baseline|Healthy Adult Volunteers|All healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
632588|NCT02485158|P1|Participant Flow|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
632589|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632590|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632591|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632592|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632593|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632594|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632595|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632596|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632597|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632598|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632599|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632600|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632601|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632712|NCT02484729|B8|Baseline|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
635557|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
632603|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632604|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632605|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632606|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632607|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632608|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632609|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632610|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632611|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632612|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632613|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632614|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632615|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632616|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632617|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632618|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632619|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632620|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632621|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632622|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632623|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632713|NCT02484729|B7|Baseline|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632624|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632625|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632626|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632627|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632628|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632629|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632630|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632631|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632632|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632633|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632634|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632635|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632636|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632637|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632638|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632639|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632640|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632641|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632642|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632643|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632644|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
635558|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
632645|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632646|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632647|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632648|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632649|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632650|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632651|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632652|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632653|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632654|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632655|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632656|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632657|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632658|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632659|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632660|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632661|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632662|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632663|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632664|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632665|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632714|NCT02484729|B6|Baseline|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632666|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632667|NCT02485158|O6|Outcome|THC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. THC placebo arm represents a session in which participants received a placebo drug.
632668|NCT02485158|O5|Outcome|ALC Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC placebo arm represents a session in which participants received a placebo beverage.
632669|NCT02485158|O4|Outcome|AMP Placebo Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP placebo arm represents a session in which participants received a placebo drug.
632670|NCT02485158|O3|Outcome|THC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At the THC drug session, they received a capsule containing THC.
632671|NCT02485158|O2|Outcome|ALC Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. ALC arm represents a session in which participants received alcohol beverage.
632672|NCT02485158|O1|Outcome|AMP Arm|All healthy adult volunteers completed a 6 session; The three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. AMP arm represents a amphetamine drug session in which participants received a capsule containing d-amphetamine.
632673|NCT02485158|E1|Reported Event|Healthy Adult Volunteers|24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo.
632674|NCT02484911|B3|Baseline|Total|Total of all reporting groups
632675|NCT02484911|B2|Baseline|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
632676|NCT02484911|B1|Baseline|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.~Olanzapine: 5mg,twice a day orally on day 1 to day 4~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
632677|NCT02484911|P2|Participant Flow|Control Regimen|"Aprepitant in combination with palonosetron and dexamethasone~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
632678|NCT02484911|P1|Participant Flow|Olanzapine Regimen|"Olanzapine in combination with aprepitant ,palonosetron and dexamethasone.~Olanzapine: 5mg,twice a day orally on day 1 to day 4~Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.~Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1~Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4"
632679|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632680|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632681|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632682|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632683|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632684|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632685|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632715|NCT02484729|B5|Baseline|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632716|NCT02484729|B4|Baseline|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632686|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632687|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632688|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632689|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632690|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632691|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632692|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632693|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632694|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632695|NCT02484911|O2|Outcome|Aprepitant Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632696|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632697|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632698|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632699|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632700|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632701|NCT02484911|O2|Outcome|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632702|NCT02484911|O1|Outcome|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632703|NCT02484911|E2|Reported Event|Control Regimen|"Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV~Day2-Day3:~Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV~Day4:~Olanzapine 5mg twice po Dexamethasone: 3.75mg IV"
632704|NCT02484911|E1|Reported Event|Olanzapine Regimen|Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
632705|NCT02484898|B1|Baseline|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
632706|NCT02484898|P1|Participant Flow|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
632707|NCT02484898|O1|Outcome|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
632708|NCT02484898|E1|Reported Event|SEEQ™ MCT/ECM System|SEEQ™ MCT/ECM monitoring for the detection of non-lethal cardiac arrhythmias.
632709|NCT02484729|B11|Baseline|Total|Total of all reporting groups
632710|NCT02484729|B10|Baseline|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632711|NCT02484729|B9|Baseline|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632730|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632731|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632732|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632733|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632734|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632735|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632736|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632737|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632738|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632739|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632740|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632741|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632742|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632743|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632744|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632745|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632746|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632747|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632748|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632749|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632750|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632751|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632752|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632753|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632754|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632755|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632756|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632757|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632758|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632759|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632760|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632761|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632762|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632763|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632764|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632765|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632766|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632767|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632768|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632769|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632770|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632771|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632772|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632773|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632774|NCT02484729|O10|Outcome|Oral Suspension (Part B)|
632817|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632818|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632775|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632776|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632777|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632778|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632779|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632780|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632781|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632782|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632783|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632784|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632785|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632786|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632787|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632788|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632789|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632790|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632791|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632792|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632793|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632794|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632795|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632796|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632797|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632798|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632799|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632800|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632801|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632802|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632803|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632804|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632805|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632806|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632807|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632808|NCT02484729|O6|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632809|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632810|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632811|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632812|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632813|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632814|NCT02484729|O10|Outcome|Oral Suspension (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632815|NCT02484729|O9|Outcome|Intellicap Device (Part B)|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632816|NCT02484729|O8|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632941|NCT02483611|B4|Baseline|Total|Total of all reporting groups
632819|NCT02484729|O5|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632820|NCT02484729|O4|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632821|NCT02484729|O3|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632822|NCT02484729|O2|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632823|NCT02484729|O1|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632824|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632825|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632826|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632827|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632828|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632829|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632830|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632831|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632832|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632833|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632834|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632835|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632836|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632837|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632838|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632839|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632840|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632841|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632842|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632843|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632844|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632845|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632846|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632847|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632848|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632849|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632850|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632851|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632852|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632853|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632854|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632855|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632856|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632857|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632858|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632859|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632860|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632861|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632862|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632863|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632864|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632865|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632866|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632867|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632868|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632869|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632870|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632871|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632872|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632873|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632874|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632875|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632876|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632877|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632878|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632879|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632880|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632881|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632882|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632883|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632884|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632885|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632886|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632887|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632888|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632889|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632890|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632891|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632892|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632893|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632894|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632895|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632896|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632897|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632898|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632899|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632900|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632901|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632902|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632903|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632904|NCT02484729|O10|Outcome|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632905|NCT02484729|O9|Outcome|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632906|NCT02484729|O8|Outcome|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632907|NCT02484729|O7|Outcome|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632908|NCT02484729|O6|Outcome|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632909|NCT02484729|O5|Outcome|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632910|NCT02484729|O4|Outcome|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632911|NCT02484729|O3|Outcome|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
635559|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
632912|NCT02484729|O2|Outcome|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632913|NCT02484729|O1|Outcome|Part A- Placebo|Subjects received matching placebo under fasted conditions
632914|NCT02484729|E10|Reported Event|Part B|Subjects received a single dose of AZD9977, under fasted conditions, on two occasions (40 mg AZD9977, IntelliCap device and 40 mg AZD9977, oral solution) separated by a washout period of at least 7 days
632915|NCT02484729|E9|Reported Event|Part A - 1200 mg AZD9977 (Split Doses)|Subjects received 1200 mg AZD9977 (split doses), oral suspension under fasted conditions
632916|NCT02484729|E8|Reported Event|Part A - 800 mg AZD9977 (Split Doses)|Subjects received 800 mg AZD9977 (split doses), oral suspension under fasted conditions
632917|NCT02484729|E7|Reported Event|Part A - 800 mg AZD9977|Subjects received 800 mg AZD9977, oral suspension under fasted conditions
632918|NCT02484729|E6|Reported Event|Part A - 400 mg AZD9977|Subjects received 400 mg AZD9977, oral suspension under fasted conditions
632919|NCT02484729|E5|Reported Event|Part A - 200 mg AZD9977|Subjects received 200 mg AZD9977, oral suspension under fasted conditions
632920|NCT02484729|E4|Reported Event|Part A - 100 mg AZD9977|Subjects received 100 mg AZD9977, oral suspension under fasted conditions
632921|NCT02484729|E3|Reported Event|Part A - 25 mg AZD9977|Subjects received 25 mg AZD9977, oral suspension under fasted conditions
632922|NCT02484729|E2|Reported Event|Part A - 5 mg AZD9977|Subjects received 5 mg AZD9977, oral suspension under fasted conditions
632923|NCT02484729|E1|Reported Event|Part A- Placebo|Subjects received matching placebo under fasted conditions
632924|NCT02483975|B3|Baseline|Total|Total of all reporting groups
632925|NCT02483975|B2|Baseline|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632926|NCT02483975|B1|Baseline|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632927|NCT02483975|P2|Participant Flow|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632928|NCT02483975|P1|Participant Flow|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 microgram (mcg) in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632929|NCT02483975|O2|Outcome|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632930|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632931|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632932|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632933|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632934|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632935|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632936|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632937|NCT02483975|O2|Outcome|Placebo|Par. received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632938|NCT02483975|O1|Outcome|Fluticasone Furoate 50 mcg|Par. received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Par. also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632939|NCT02483975|E2|Reported Event|Placebo|Participants received one inhalation, once daily of placebo in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
632940|NCT02483975|E1|Reported Event|Fluticasone Furoate 50 mcg|Participants received one inhalation, once daily of FF 50 mcg in the morning via ELLIPTA inhaler for 6 wks. Participants also received open label montelukast throughout the treatment period and were supplied with albuterol/salbutamol inhalation aerosol to use as needed to treat acute asthma symptoms.
635569|NCT02429258|E1|Reported Event|Dapagliflozin|Dapagliflozin + Metformin or Insulin
632942|NCT02483611|B3|Baseline|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632943|NCT02483611|B2|Baseline|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632944|NCT02483611|B1|Baseline|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632945|NCT02483611|P3|Participant Flow|Group C (Control Group - Isotonic Solution)|This group received isotonic solution in a equivalent volume as a bolus over 5 minutes, followed by continuous intravenous infusion of isotonic solution during the surgery.
632946|NCT02483611|P2|Participant Flow|Group ML (Magnesium Sulfate Plus Lidocaine)|This group received Magnesium Sulfate (MS) 40 mg/kg plus lidocaine 3 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h plus lidocaine 3 mg/kg/h during the surgery.
632947|NCT02483611|P1|Participant Flow|Group M (Magnesium Sulfate)|This group received Magnesium Sulfate (MS) 40 mg/kg as a bolus over 5 minutes, followed by continuous intravenous infusion of MS 20 mg/kg/h during the surgery.
632948|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632949|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632950|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632951|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632952|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632953|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632954|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632955|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632956|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632957|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632958|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632959|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632960|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632961|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632962|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632963|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632964|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632965|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632966|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632967|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632968|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632969|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632970|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632971|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632972|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632973|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632974|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632975|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632976|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632977|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632978|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632979|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632980|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632981|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632982|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632983|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632984|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632985|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632986|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632987|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632988|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632989|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632990|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632991|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632992|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632993|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632994|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632995|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632996|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
632997|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
632998|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
632999|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633000|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633001|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
635560|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
633002|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633003|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633004|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633005|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633006|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633007|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633008|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633009|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633010|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633011|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633012|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633013|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633014|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633015|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633016|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633017|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633018|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633019|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633020|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633021|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633022|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633023|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633024|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633025|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633026|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633027|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633028|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633029|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633030|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633031|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
640269|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
633032|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633033|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633034|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633035|NCT02483611|O3|Outcome|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633036|NCT02483611|O2|Outcome|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633037|NCT02483611|O1|Outcome|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633038|NCT02483611|E3|Reported Event|Group C|"Isotonic Solution. In this group, the patients received the volume of isotonic solution equivalent to the volume of solution infused into experimental groups~Isotonic Solution"
633039|NCT02483611|E2|Reported Event|Group ML|"Magnesium Sulfate plus Lidocaine. In this group, the patients received 40 mg/kg of Magnesium Sulfate plus 3 mg kg-1 lidocaine as a bolus and 20 mg/kg/h and 3 mg/kg/h, respectively, by infusion continuously during the surgery~Magnesium Sulfate~Lidocaine"
633040|NCT02483611|E1|Reported Event|Group M|"Magnesium Sulfate. In this group, the patients received magnesium sulfate 40 mg/Kg as a bolus and 20 mg/kg/h by continuous IV infusion during surgery~Magnesium Sulfate"
633041|NCT02481934|B1|Baseline|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive: two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
633042|NCT02481934|P1|Participant Flow|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
633043|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
633044|NCT02481934|O1|Outcome|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
633045|NCT02481934|E1|Reported Event|NKAE Cells Infusion + Chemotherapy|"Expanded and activated autologous NK cells (NKAEs) + chemotherapy (lenalidomide OR bortezomib).~NKAE cells infusion: Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.~Lenalidomide: Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.~Bortezomib: bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles."
633046|NCT02481219|B3|Baseline|Total|Total of all reporting groups
633047|NCT02481219|B2|Baseline|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633048|NCT02481219|B1|Baseline|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633049|NCT02481219|P2|Participant Flow|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633050|NCT02481219|P1|Participant Flow|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633066|NCT02480712|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
635561|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
633051|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633052|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633053|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633054|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633055|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633056|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633057|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure- Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633058|NCT02481219|O1|Outcome|Bowel Preparation Regimen - Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633059|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633060|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633061|NCT02481219|O2|Outcome|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633062|NCT02481219|O1|Outcome|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-CONTROL~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633063|NCT02481219|E2|Reported Event|Bowel Preparation Regimen-Test|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Test~Senna tablets~PEG~Metoclopramide~Erythromycin~Bisacodyl~SUPREP oral sulfate solution with Gastrografin"
633064|NCT02481219|E1|Reported Event|Bowel Preparation Regimen -Control|"Regimen includes administration of:~Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.~PillCam® COLON 2 procedure-Control~Senna tablets~PEG~Metoclopramide~Erythromycin~SUPREP oral sulfate solution~Bisacodyl"
633065|NCT02480712|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
635562|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
633067|NCT02480712|O3|Outcome|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
633068|NCT02480712|O2|Outcome|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
633069|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
633070|NCT02480712|O3|Outcome|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
633071|NCT02480712|O2|Outcome|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
633072|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and ritonavir (RTV) or cobicistat (COBI)-boosted protease inhibitors (PIs) or other agents (eg, elvitegravir (EVG)/COBI)) are summarized in this group.
633073|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
633074|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
633075|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
633076|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
633077|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
633078|NCT02480712|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1
633079|NCT02480712|E3|Reported Event|SOF/VEL 12 Weeks (Non TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants taking regimens that do not contain TDF.
633080|NCT02480712|E2|Reported Event|SOF/VEL 12 Weeks (Non-Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data are summarized for participants who took non-boosted TDF-containing regimens (defined as regimens containing TDF and non-RTV or COBI-boosted PIs or other agents).
633081|NCT02480712|E1|Reported Event|SOF/VEL 12 Weeks (Boosted TDF Containing Regimens)|SOF/VEL (400/100 mg) FDC tablet orally once daily in HCV treatment-naive and treatment-experienced (including treatment intolerant) participants with chronic HCV infection who were coinfected with HIV-1. Data for participants who took boosted TDF-containing regimens (defined as regimens containing TDF and RTV or COBI-boosted PIs or other agents (eg, EVG/COBI)) are summarized in this group.
633082|NCT02480582|B1|Baseline|Overall Sample|Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack.
633083|NCT02480582|P6|Participant Flow|No Food, Then Almond, Then Cheese Savouries|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
633084|NCT02480582|P5|Participant Flow|Almond, Then Cheese Savouries, Then No Food|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.
633085|NCT02480582|P4|Participant Flow|Cheese Savouries, Then No Food, Then Almond|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.
633086|NCT02480582|P3|Participant Flow|No Food, Then Cheese Savouries, Then Almond|Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.
633087|NCT02480582|P2|Participant Flow|Cheese Savouries Then Almond, Then No Food|Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.
633558|NCT02470403|P3|Participant Flow|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633088|NCT02480582|P1|Participant Flow|Almond, Then No Food, Then Cheese Savouries|Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.
633089|NCT02480582|O3|Outcome|No Food|No food provided, just water
633090|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits~Cheese Savouries"
633091|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds~Almonds"
633092|NCT02480582|O3|Outcome|No Food|No food provided, just water
633093|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits~Cheese Savouries"
633094|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds~Almonds"
633095|NCT02480582|O3|Outcome|No Food|No food provided, just water
633096|NCT02480582|O2|Outcome|Cheese Savouries|"Sainsbury's savoury biscuits~Cheese Savouries"
633097|NCT02480582|O1|Outcome|Almonds|"Whole, raw almonds~Almonds"
633098|NCT02480582|O3|Outcome|No Food|No food provided, just water
633099|NCT02480582|O2|Outcome|Cheese Savouries|Sainsbury's savoury biscuits Cheese Savouries
633100|NCT02480582|O1|Outcome|Almonds|Whole, raw almonds Almonds
633101|NCT02480582|E6|Reported Event|No Food, Then Almond, Then Cheese Savouries|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received a mid-morning snack of cheese savouries.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
633102|NCT02480582|E5|Reported Event|Almond, Then Cheese Savouries, Then No Food|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received no food.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
633103|NCT02480582|E4|Reported Event|Cheese Savouries, Then No Food, Then Almond|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of almonds.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
633104|NCT02480582|E3|Reported Event|No Food, Then Cheese Savouries, Then Almond|"Participants first received no food. After a washout period of 5 days, they then received a mid-morning snack of cheese savouries. Finally, after another washout period participants received a mid-morning snack of almonds.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
633105|NCT02480582|E2|Reported Event|Cheese Savouries Then Almond, Then No Food|"Participants first received a mid-morning snack of cheese savouries. After a washout period of 5 days, they then received a mid-morning snack of almonds. Finally, after another washout period participants received no food.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
633106|NCT02480582|E1|Reported Event|Almond, Then No Food, Then Cheese Savouries|"Participants first received a mid-morning snack of almonds. After a washout period of 5 days, they then received no food. Finally, after another washout period participants received a mid-morning snack of cheese savouries.~Dosage was 0.9g/kg of 1) Whole raw almonds, 2) Cheese savoury crackers, 3) no food given in a randomised cross-over design with order determined by Latin square (i.e. 6 order permutations). Doses were administered once as a mid-morning snack."
633107|NCT02480439|B4|Baseline|Total|Total of all reporting groups
633108|NCT02480439|B3|Baseline|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
633109|NCT02480439|B2|Baseline|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
633110|NCT02480439|B1|Baseline|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
633111|NCT02480439|P3|Participant Flow|TAK-648 Sequence CAB|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, after a high fat meal, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 3.
633112|NCT02480439|P2|Participant Flow|TAK-648 Sequence BCA|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 3.
633113|NCT02480439|P1|Participant Flow|TAK-648 Sequence ABC|Regimen A TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, followed by at least 7 day washout period, followed by Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 2, followed by at least 7 day washout period, followed by Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 3.
633114|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633115|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633116|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
633117|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633118|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633119|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
633120|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633121|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633122|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
633123|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633124|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633125|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
633126|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633127|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633128|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
633129|NCT02480439|O3|Outcome|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633130|NCT02480439|O2|Outcome|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633131|NCT02480439|O1|Outcome|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
633132|NCT02480439|E3|Reported Event|TAK-648 Regimen C|Regimen C TAK-648 0.3 mg, solution, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633133|NCT02480439|E2|Reported Event|TAK-648 Regimen B|Regimen B TAK-648 0.3 mg, tablet, orally, in fasted state, once on Day 1 of Period 1, 2 or 3.
633134|NCT02480439|E1|Reported Event|TAK-648 Regimen A|TAK-648 0.3 mg, tablet, orally, 30 minutes after a high fat meal, once on Day 1 of Period 1, 2 or 3.
633135|NCT02480010|B3|Baseline|Total|Total of all reporting groups
633136|NCT02480010|B2|Baseline|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633137|NCT02480010|B1|Baseline|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633138|NCT02480010|P2|Participant Flow|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633139|NCT02480010|P1|Participant Flow|Pertuzumab 420 Milligrams (mg) - Cohort A|Participants in Cohort A received an intravenous (IV) loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633140|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633141|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633142|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633143|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633144|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633145|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633146|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633147|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633148|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633149|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633150|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633151|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633152|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633153|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633154|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633155|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633156|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633157|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633158|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633159|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633160|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633161|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633162|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633163|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633164|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633165|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633166|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633167|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633168|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633169|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633170|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633171|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633172|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633173|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633174|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633175|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633176|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633387|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
633177|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633178|NCT02480010|O2|Outcome|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633179|NCT02480010|O1|Outcome|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633180|NCT02480010|E2|Reported Event|Pertuzumab 1050 mg - Cohort B|Participants in Cohort B received 1050 mg pertuzumab as an IV infusion on Day 1 of each 3-week cycle for a maximum of 36 cycles or until study termination.
633181|NCT02480010|E1|Reported Event|Pertuzumab 420 mg - Cohort A|Participants in Cohort A received an IV loading dose of 840 mg pertuzumab on Day 1 of Cycle 1 (3-week cycles); from Cycle 2 onwards, participants received IV infusions of 420 mg on Day 1. Treatment continued for a maximum of 36 cycles or until study termination.
633182|NCT02479763|B3|Baseline|Total|Total of all reporting groups
633183|NCT02479763|B2|Baseline|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
633184|NCT02479763|B1|Baseline|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
633185|NCT02479763|P2|Participant Flow|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
633186|NCT02479763|P1|Participant Flow|Conventional Loss-of-resistance|Conventional loss-of-resistance: Using tactile feeling to identify thoracic epidural space
633187|NCT02479763|O2|Outcome|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
633188|NCT02479763|O1|Outcome|Conventional Loss-of-resistance|
633189|NCT02479763|E2|Reported Event|Waveform-confirmed Loss-of-resistance|Waveform-confirmed loss-of-resistance: Using waveform analysis to confirm thoracic epidural space
633190|NCT02479763|E1|Reported Event|Conventional Loss-of-resistance|
633191|NCT02478671|B1|Baseline|TR Band|MRI based Radial artery measurement
633192|NCT02478671|P1|Participant Flow|TR Band|MRI based radial artery measurement
633193|NCT02478671|O1|Outcome|TR Band|Pulse Oxymetry
633194|NCT02478671|O1|Outcome|TR Band|MRI based Radial artery measurement
633195|NCT02478671|E1|Reported Event|TR Band|MRI based radial artery measurement
633196|NCT02478580|B3|Baseline|Total|Total of all reporting groups
633197|NCT02478580|B2|Baseline|Control|Placebo in preoperative area
633198|NCT02478580|B1|Baseline|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
633199|NCT02478580|P2|Participant Flow|Control|Placebo in preoperative area
633200|NCT02478580|P1|Participant Flow|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
633201|NCT02478580|O2|Outcome|Control|Placebo in preoperative area
633202|NCT02478580|O1|Outcome|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
633203|NCT02478580|E2|Reported Event|Control|Placebo in preoperative area
633204|NCT02478580|E1|Reported Event|Nuvigil|"A single oral dose of Nuvigil 150mg in preoperative area~NUVIGIL: Patient will receive Nuvigil before the surgery"
633205|NCT02478372|B3|Baseline|Total|Total of all reporting groups
633206|NCT02478372|B2|Baseline|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633207|NCT02478372|B1|Baseline|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633208|NCT02478372|P2|Participant Flow|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633246|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633388|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
633209|NCT02478372|P1|Participant Flow|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633210|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633211|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633212|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633213|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633214|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633215|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633216|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633217|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633247|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633218|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633219|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633220|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633221|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633222|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633223|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633224|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633225|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633226|NCT02478372|O2|Outcome|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633559|NCT02470403|P2|Participant Flow|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
633227|NCT02478372|O1|Outcome|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633228|NCT02478372|E2|Reported Event|Local Infiltration Analgesia (LIA)|"Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine. 50ml injected following bone preparation prior to implant cementation perpendicular to the posterior femur through the posterior joint capsule in 10ml aliquots. 30ml proximal to the suprapatellar pouch down to the femur.100ml spread into subcutaneous tissues including; collateral and cruciate ligaments, fatty and connective tissue on the anterior aspect of the incision. A 16 gauge epidural catheter inserted via a medial portal, 20ml was injected via the catheter following closure of wound. Post-operatively, patients received boluses of 40ml ropivacaine 0.2% via the catheter using a mechanical McKinley 595 pump 4 hours after leaving theatre, at 22:00 and 08:00 on post-operative day one.~Local Infiltration Analgesia (LIA): Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine."
633229|NCT02478372|E1|Reported Event|Patient Controlled Epidural (PCEA)|A lumbar epidural was sited following establishment of the spinal blockade. Following the completion of the operation, patients received 4ml of 0.25% levobupivacaine prior to leaving the operating room. Thereafter they were connected to a PCEA pump (McKinley 545) with no background infusion. Patients could self-medicate with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one). Nurse-administered rescue top-ups of 4ml of 0.25% levobupivacaine were available for insufficient analgesia. The epidural catheter was removed on the morning of post-operative day two (POD2).
633230|NCT02477709|B1|Baseline|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
633231|NCT02477709|P1|Participant Flow|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
633232|NCT02477709|O1|Outcome|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
633233|NCT02477709|E1|Reported Event|Gefapixant|Gefapixant oral tablets (150 mg) administered as a single dose gefapixant: gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
633234|NCT02476422|B3|Baseline|Total|Total of all reporting groups
633235|NCT02476422|B2|Baseline|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633236|NCT02476422|B1|Baseline|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633237|NCT02476422|P2|Participant Flow|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633238|NCT02476422|P1|Participant Flow|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633239|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633240|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633241|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633242|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633243|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633244|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633245|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
635563|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
633248|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633249|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633250|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633251|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633252|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633253|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633254|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633255|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633256|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633257|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633258|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633259|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633260|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633261|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633262|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633263|NCT02476422|O2|Outcome|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633264|NCT02476422|O1|Outcome|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633265|NCT02476422|E2|Reported Event|Ibuprofen + Placebo to Diclofenac Potassium|Single dose of ibuprofen 400 mg tablet was given once patient develops moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule was also given to patient in order to maintain double dummy method.
633266|NCT02476422|E1|Reported Event|Dilcofenac Potassium + Placebo to Ibuprofen|Single dose of diclofenac potassium 50 mg soft gelatin capsule was given once patient developed moderate to severe pain post the extraction of two ipsilateral third molar teeth. Single dose of placebo to ibuprofen 400 mg tablet was also given to patient in order to maintain double dummy method.
633288|NCT02475564|E1|Reported Event|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
633389|NCT02473367|E4|Reported Event|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
633267|NCT02475980|B1|Baseline|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633268|NCT02475980|P1|Participant Flow|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633269|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633270|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633271|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633272|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633273|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633274|NCT02475980|O1|Outcome|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633275|NCT02475980|E1|Reported Event|Adolescent Girls|"Adolescent post-menarchal girls ages 13-18 with Medicaid insurance presenting to a pediatric emergency department for a non-emergent complaint who receive comprehensive contraception counseling~Comprehensive contraception counseling: The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician."
633276|NCT02475564|B3|Baseline|Total|Total of all reporting groups
633277|NCT02475564|B2|Baseline|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
633278|NCT02475564|B1|Baseline|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
633279|NCT02475564|P2|Participant Flow|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
633280|NCT02475564|P1|Participant Flow|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
633281|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
633282|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
633283|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
633284|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
633285|NCT02475564|O2|Outcome|Placebo|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 1 pill of placebo (starch)~Placebo: 40mg of starch"
633286|NCT02475564|O1|Outcome|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
633287|NCT02475564|E2|Reported Event|Resveratrol|"Patients will take once a day a monophasic pill (ethinylestradiol + levonorgestrel) continuously for 42 days with 40mg of resveratrol~Resveratrol: 40mg of resveratrol (powder)"
633560|NCT02470403|P1|Participant Flow|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633289|NCT02475278|B1|Baseline|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633290|NCT02475278|P1|Participant Flow|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633291|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633292|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633293|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633294|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633295|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633296|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633297|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633298|NCT02475278|O1|Outcome|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633299|NCT02475278|E1|Reported Event|NoV Vaccine|Norovirus GI.1/GII.4 bivalent Virus-Like Particle (VLP) vaccine (NoV Vaccine) (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP, adjuvanted with 500 µg aluminum hydroxide), intramuscular (IM) injection, once on Day 1.
633300|NCT02475031|B3|Baseline|Total|Total of all reporting groups
633301|NCT02475031|B2|Baseline|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633302|NCT02475031|B1|Baseline|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633303|NCT02475031|P2|Participant Flow|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633304|NCT02475031|P1|Participant Flow|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633305|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633306|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633353|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633307|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633308|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633309|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633310|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633311|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP-C: TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
633312|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP-S: Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case."
633313|NCT02475031|O2|Outcome|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633314|NCT02475031|O1|Outcome|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633315|NCT02475031|E2|Reported Event|Active Group (TAP-C)|"(TAP-C) - The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633316|NCT02475031|E1|Reported Event|Placebo Group (TAP-S)|"(TAP-S) – the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter~TAP Catheters: Both groups will have catheters inserted into the TAP area after a single shot TAP block~Placebo: Placebo Group (TAP-S) (TAP-S) - the On-Q reservoir will be filled with saline and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~ropivacaine: The On-Q reservoir will be filled with 0.2% ropivacaine and set to infuse at rate of 10 ml/hr through the TAP catheter Both groups will receive single shot TAP block with 30ml 0.5% ropivacaine at the end of case~Oxycodone/Acetaminophen"
633317|NCT02474498|B4|Baseline|Total|Total of all reporting groups
633318|NCT02474498|B3|Baseline|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633319|NCT02474498|B2|Baseline|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
635564|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
633320|NCT02474498|B1|Baseline|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633321|NCT02474498|P3|Participant Flow|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
633322|NCT02474498|P2|Participant Flow|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633323|NCT02474498|P1|Participant Flow|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633324|NCT02474498|O3|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
633325|NCT02474498|O2|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633326|NCT02474498|O1|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633327|NCT02474498|O3|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces.This mixture will be used to completely fill the defect (EMD + βTCP/HA).
633328|NCT02474498|O2|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633354|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633390|NCT02473367|E3|Reported Event|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
633329|NCT02474498|O1|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633330|NCT02474498|O3|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633331|NCT02474498|O2|Outcome|EMD + βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).
633332|NCT02474498|O1|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633333|NCT02474498|O3|Outcome|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633334|NCT02474498|O2|Outcome|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633335|NCT02474498|O1|Outcome|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633336|NCT02474498|E3|Reported Event|EMD Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland) and after the flap will be repositioned.~EMD: During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633337|NCT02474498|E2|Reported Event|βTCP/HA + EMD|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a mixture of enamel matrix derivative proteins (EMD) (Emdogain® Straumann, Basel, Switzerland) and bone substitute consisting of βTCP/HA (Bone Ceramic® Straumann, Basel, Switzerland). Immediately after debridement, EMD will be applied on the root surfaces. The remaining part of the material in the seringe will be then mixed with the bone substitute on a sterile dappen. This mixture will be used to completely fill the defect (EMD + βTCP/HA).~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633338|NCT02474498|E1|Reported Event|βTCP/HA Alone|"During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~βTCP/HA: During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)~Flap access surgery: In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments."
633339|NCT02473523|B1|Baseline|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633340|NCT02473523|P1|Participant Flow|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633341|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633342|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633343|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633344|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633345|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633346|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633347|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633348|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633349|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633350|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633351|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633352|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633385|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
633386|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
633355|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633356|NCT02473523|O1|Outcome|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633357|NCT02473523|E1|Reported Event|Participants|"Leukemia, Hodgkin Lymphoma and non-Hodgkin's Lymphoma patients who meet eligibility requirements and consent to participate in the study.~Participants were to undergo the following interventions: Yoga Therapy, PedsQL Multidimensional Fatigue Scale, PedsQL Cancer Module, Verbal Numeric Pain Scale. Biodex System 3 Dynamometer, Jamar Hydraulic Hand Dynamometer, Sit and Reach Test, and Test of Motor Proficiency."
633358|NCT02473510|B3|Baseline|Total|Total of all reporting groups
633359|NCT02473510|B2|Baseline|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633360|NCT02473510|B1|Baseline|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633361|NCT02473510|P2|Participant Flow|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633362|NCT02473510|P1|Participant Flow|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633363|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633364|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633365|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633366|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633367|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633368|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633369|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633370|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633371|NCT02473510|O2|Outcome|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633372|NCT02473510|O1|Outcome|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633373|NCT02473510|E2|Reported Event|Trivalent Influenza Vaccine|Participants received a single dose of trivalent influenza vaccine [10^7.0 +/- 0.5 fluorescent focus unit (FFU) of each of 3 cold adapted (ca), attenuated (att), temperature sensitive (ts) 6:2 reassortant influenza strains] by intranasal spray on Day 1.
633374|NCT02473510|E1|Reported Event|Placebo|Participants received a single dose of placebo matching with trivalent influenza vaccine by intranasal spray on Day 1.
633375|NCT02473367|B1|Baseline|All Enrolled Participants|All participants who enrolled in the study
633376|NCT02473367|P1|Participant Flow|Four Period Fixed Sequence|All participants entered the first of four treatment periods. Period 1: 1200 mg raltegravir alone; followed by Period 2: 1200 mg raltegravir and TUMS Ultra Strength (US) 1000 taken orally concomitantly; followed by Period 3: 1200 mg raltegravir and 12 hours later with 20 mL Leader Antacid Maximum Strength (MS) taken orally; followed by Period 4: 1200 mg raltegravir and 12 hours later with three tablets of TUMS US 1000 taken orally. There was a maximum 7-day wait between each period where participants were treated once daily with 1200 mg raltegravir.
633377|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
633378|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
633379|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
633380|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
633381|NCT02473367|O4|Outcome|Period 4: Raltegravir + 12 Hrs TUMS|1200 mg raltegravir once at the start of Period 4, and 12 hours later with 3 tablets of TUMS US 1000
633382|NCT02473367|O3|Outcome|Period 3: Raltegravir + 12 Hrs Leader Antacid|1200 mg raltegravir once at the start of Period 3, and 12 hours later with 20 mL Leader Antacid MS
633383|NCT02473367|O2|Outcome|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
633384|NCT02473367|O1|Outcome|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
633391|NCT02473367|E2|Reported Event|Period 2: Raltegravir + TUMS Concomitantly|1200 mg raltegravir and three tablets of TUMS US 1000 concomitantly once at the start of Period 2
633392|NCT02473367|E1|Reported Event|Period 1: Raltegravir Only|1200 mg raltegravir, once at the start of Period 1
633393|NCT02472886|B4|Baseline|Total|Total of all reporting groups
633394|NCT02472886|B3|Baseline|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633395|NCT02472886|B2|Baseline|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633396|NCT02472886|B1|Baseline|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF(90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
633397|NCT02472886|P3|Participant Flow|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir (SOF) study
633398|NCT02472886|P2|Participant Flow|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633399|NCT02472886|P1|Participant Flow|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|Ledipasvir/sofosbuvir (LDV/SOF; Harvoni®) (90/400 mg) fixed dose combination (FDC) tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
633400|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV Experienced)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants were on a stable ARV regimen for at least 8 weeks prior to screening.
633401|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected, ARV- Naive)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1. These participants did not receive any prior ARV therapy.
633402|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633403|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633404|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633405|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosiss
633406|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633407|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633408|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
633409|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633410|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633411|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
633412|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633413|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633414|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
633415|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633416|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633417|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive participants with genotype 1 HCV infection without cirrhosis
633418|NCT02472886|O3|Outcome|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633419|NCT02472886|O2|Outcome|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633420|NCT02472886|O1|Outcome|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
633421|NCT02472886|E3|Reported Event|LDV/SOF + RBV 12 Weeks (TE, SOF-treated, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily + weight-based ribavirin (RBV) (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 or 3 HCV infection who failed to achieve SVR in a previous Gilead sofosbuvir study
633422|NCT02472886|E2|Reported Event|LDV/SOF 8 Weeks (TN, HCV/HIV-coinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment naive participants with genotype 1 HCV infection without cirrhosis and coinfected with HIV-1
633423|NCT02472886|E1|Reported Event|LDV/SOF 8 Weeks (TN, HCV-monoinfected)|LDV/SOF (90/400 mg) FDC tablet once daily for 8 weeks in treatment-naive (TN) participants with genotype 1 HCV infection without cirrhosis
633424|NCT02472847|B3|Baseline|Total|Total of all reporting groups
633425|NCT02472847|B2|Baseline|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
633426|NCT02472847|B1|Baseline|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
633427|NCT02472847|P2|Participant Flow|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
633428|NCT02472847|P1|Participant Flow|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
633429|NCT02472847|O2|Outcome|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
633430|NCT02472847|O1|Outcome|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
633431|NCT02472847|E2|Reported Event|Dronabinol|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning~Dronabinol: Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol."
633432|NCT02472847|E1|Reported Event|Placebo|"In a randomized, double-blind, placebo-controlled, between-subjects design, the investigators will couple a standard Pavlovian fear extinction paradigm in fMRI with an acute pharmacological challenge with oral dronabinol (synthetic THC) or placebo 2 hours prior to extinction learning in healthy adult volunteers and test extinction retention and maintenance 24 hours and 1 week later, respectively, after extinction learning.~Placebo: Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo."
633433|NCT02472756|B1|Baseline|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
633434|NCT02472756|P1|Participant Flow|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician’s discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
633435|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
633436|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
633437|NCT02472756|O1|Outcome|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
633438|NCT02472756|E1|Reported Event|Follicular Lymphoma Participants|Previously treated adult participants with relapsed/refractory follicular lymphoma received induction treatment with rituximab in combination with chemotherapy regimen for approximately 6 months followed by maintenance therapy with rituximab for a maximum of 2 years. All treatments prescribed during the observation period were at the treating physician's discretion. Participants were followed up for safety and efficacy evaluation in accordance with routine practice, up to 30 months.
633439|NCT02472522|B3|Baseline|Total|Total of all reporting groups
633440|NCT02472522|B2|Baseline|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633441|NCT02472522|B1|Baseline|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633442|NCT02472522|P2|Participant Flow|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633443|NCT02472522|P1|Participant Flow|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633444|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633445|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633446|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633458|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633447|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633448|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633449|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633450|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633451|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633452|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633453|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633454|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633455|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633456|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633457|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633561|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633459|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633460|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying the inclusion criteria received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633461|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block was performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will received Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633462|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633463|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633464|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633465|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633466|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633467|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633468|NCT02472522|O2|Outcome|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633469|NCT02472522|O1|Outcome|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633562|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633470|NCT02472522|E2|Reported Event|Ropivacaine + Dexmedetomidine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with addition of Dexmedetomidine 1 micrograms/kg to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block~Ropivacaine + Dexmedetomidine: Addition of Dexmedetomidine 1 micrograms/kg (to with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml ) for the TAP block"
633471|NCT02472522|E1|Reported Event|Ropivacaine|"Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)~Ropivacaine: Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)"
633472|NCT02472366|B3|Baseline|Total|Total of all reporting groups
633473|NCT02472366|B2|Baseline|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633474|NCT02472366|B1|Baseline|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633475|NCT02472366|P2|Participant Flow|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633476|NCT02472366|P1|Participant Flow|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633477|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633478|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633479|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633480|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633481|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633482|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633483|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633484|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633485|NCT02472366|O2|Outcome|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633486|NCT02472366|O1|Outcome|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633487|NCT02472366|E2|Reported Event|Laser and Anti-VEGF|"laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633488|NCT02472366|E1|Reported Event|Laser|"laser with or without prior history of intraocular corticosteroid therapy~ILUVIEN"
633489|NCT02471755|B3|Baseline|Total|Total of all reporting groups
633490|NCT02471755|B2|Baseline|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633491|NCT02471755|B1|Baseline|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633492|NCT02471755|P2|Participant Flow|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633493|NCT02471755|P1|Participant Flow|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633518|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed ventilatory support postoperatively
633494|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633495|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633496|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633497|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633498|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633499|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633500|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633501|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633502|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633519|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed ventilatory support postoperatively
633662|NCT02467777|O1|Outcome|Forced Air|"Bair Hugger~Bair Hugger"
633503|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633504|NCT02471755|O2|Outcome|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633505|NCT02471755|O1|Outcome|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633506|NCT02471755|E2|Reported Event|Sham Electro-acupuncture Group|Sham Eelectro-acupuncture: Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints’ location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
633507|NCT02471755|E1|Reported Event|Electro-acupuncture Group|Eelectro-acupuncture: The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
633508|NCT02471612|B1|Baseline|Emergency Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the APACHE-2 Score & P-POSSUM Score
633509|NCT02471612|P1|Participant Flow|All Patients Who Underwent Emergency Exploratory Laparotomy|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were scored using the P-POSSUM Score APACHE-II
633510|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were observed if they needed re-exploration during the post-operative period.
633511|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were observed if they needed re-exploration during the post-operative period.
633512|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the Acute Kidney Injury
633513|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the Acute Kidney Injury
633514|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
633515|NCT02471612|O1|Outcome|Patients Who Survived|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for Cardiac morbidity (Acute Myocardial Infarction (AMI) or arrhythmias needing treatment)
633516|NCT02471612|O2|Outcome|Patients Who Died|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and died during the study period were monitored for the need for inotropic support during their stay..
633517|NCT02471612|O1|Outcome|Surviving Patients|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria and survived during the study period were monitored for the need for inotropic support during their stay..
633520|NCT02471612|O1|Outcome|Length of Stay|All patients who underwent emergency exploratory laparotomy from December 2013 to November 2014 at the Tata Main Hospital, Jamshedpur, and met the inclusion criteria were observed for their length of stay (LOS)
633521|NCT02471612|O2|Outcome|AUC Using P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery.
633522|NCT02471612|O1|Outcome|AUC Using APACHE II|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
633523|NCT02471612|E2|Reported Event|P-POSSUM|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with P-POSSUM on the day of surgery
633524|NCT02471612|E1|Reported Event|APACHE-2 Scoring|All patients undergoing emergency laparotomy at Tata Main Hospital form 01st December 2013 to 30th November 2014 were included in the study. All patients were scored with APACHE II on the day of surgery.
633525|NCT02470949|B1|Baseline|All Study Participants|High Social Status Condition in Monopoly Game and Low Social Status Condition in Monopoly Game
633526|NCT02470949|P2|Participant Flow|High Social Status, Then Low Social Status|High Social Status Condition in Monopoly Game during the first intervention period and Low Social Status Condition in Monopoly Game during the second intervention period (after washout period).
633527|NCT02470949|P1|Participant Flow|Low Social Status, Then High Social Status|Low Social Status Condition in Monopoly Game during the first intervention period and High Social Status Condition in Monopoly Game during the second intervention period (after washout period).
633528|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633529|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633530|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~High Social Status: The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633531|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Low Social Status: The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633532|NCT02470949|O2|Outcome|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633533|NCT02470949|O1|Outcome|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633534|NCT02470949|E2|Reported Event|High Social Status|"High Social Status Condition in Monopoly Game~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633535|NCT02470949|E1|Reported Event|Low Social Status|"Low Social Status Condition in Monopoly Game.~Manipulated Social Status: The participants will be randomized to either the Low Social Status Condition or the High Social Status condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit."
633536|NCT02470429|B3|Baseline|Total|Total of all reporting groups
633537|NCT02470429|B2|Baseline|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633538|NCT02470429|B1|Baseline|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633539|NCT02470429|P2|Participant Flow|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633540|NCT02470429|P1|Participant Flow|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633541|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633542|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633543|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633544|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633545|NCT02470429|O2|Outcome|Hyabak 0.15%|Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633546|NCT02470429|O1|Outcome|SYSTANE HYDRATION|SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
633547|NCT02470429|E3|Reported Event|Hyabak 0.15%|All subjects treated with Hyabak 0.15% eye drops
633548|NCT02470429|E2|Reported Event|SYSTANE HYDRATION|All subjects treated with SYSTANE HYDRATION lubricant eye drops
633549|NCT02470429|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
633550|NCT02470403|B6|Baseline|Total|Total of all reporting groups
633551|NCT02470403|B5|Baseline|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
633552|NCT02470403|B4|Baseline|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633553|NCT02470403|B3|Baseline|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633554|NCT02470403|B2|Baseline|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
633555|NCT02470403|B1|Baseline|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633556|NCT02470403|P5|Participant Flow|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
633557|NCT02470403|P4|Participant Flow|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633563|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633564|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633565|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633566|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633567|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633568|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633569|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633570|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633571|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633572|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633573|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633574|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633575|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633576|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633577|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633578|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633579|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633580|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633581|NCT02470403|O3|Outcome|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
633582|NCT02470403|O2|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633583|NCT02470403|O1|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633584|NCT02470403|O4|Outcome|Part 1 and 2 : Pooled Placebo|Placebo subjects were pooled between the 2 parts and were considered a single treatment arm for the analyses
633585|NCT02470403|O3|Outcome|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633586|NCT02470403|O2|Outcome|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633587|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633588|NCT02470403|O2|Outcome|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
633589|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633590|NCT02470403|O2|Outcome|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
633591|NCT02470403|O1|Outcome|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633592|NCT02470403|E5|Reported Event|Part 2: Placebo Three Times Daily|Matching placebo tablets tid before meals.
633593|NCT02470403|E4|Reported Event|Part 2: LIK066 50 mg Three Times Daily (Tid)|LIK066 50 mg tid before all 3 meals;
633594|NCT02470403|E3|Reported Event|Part 2: LIK066 75 mg Twice Daily (Bid)|LIK066 75 mg bid before breakfast and dinner
633595|NCT02470403|E2|Reported Event|Part 1: Placebo Once Daily|Matching placebo tablets of LIK066 150 mg within 15 minutes before starting lunch.
633596|NCT02470403|E1|Reported Event|Part 1: LIK066 150 mg Once Daily (qd)|LIK066 150 mg qd within 15 minutes before starting lunch
633597|NCT02469961|B3|Baseline|Total|Total of all reporting groups
633598|NCT02469961|B2|Baseline|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633599|NCT02469961|B1|Baseline|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633600|NCT02469961|P2|Participant Flow|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633601|NCT02469961|P1|Participant Flow|Dexmedetomidne|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633602|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633603|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633604|NCT02469961|O2|Outcome|Dexmedetomidine|Patients who received Dexmedetomidine
633605|NCT02469961|O1|Outcome|Propofol|Patients who received Propofol
633606|NCT02469961|O2|Outcome|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633663|NCT02467777|E2|Reported Event|Conductive Warming|"VitaHeat~VitaHeat"
633607|NCT02469961|O1|Outcome|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633608|NCT02469961|O2|Outcome|Propofol|Number of patients required airway manipulations
633609|NCT02469961|O1|Outcome|Dexmedetomidine|Number of patients required airway manipulation
633610|NCT02469961|E2|Reported Event|Propofol|"Participants will receive an interscalene block and be sedated with propofol~Propofol: Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidme~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633611|NCT02469961|E1|Reported Event|Dexmedetomidine|"Participants will receive an interscalene block and be sedated with dexmedetomidine~Dexmedetomidine: Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol~Interscalene block: Interscalene block is used for the main anesthetic for the case"
633612|NCT02469597|B3|Baseline|Total|Total of all reporting groups
633613|NCT02469597|B2|Baseline|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633614|NCT02469597|B1|Baseline|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633615|NCT02469597|P2|Participant Flow|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633616|NCT02469597|P1|Participant Flow|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633617|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633618|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633619|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633620|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633621|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633622|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633623|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633624|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633625|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633626|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633627|NCT02469597|O2|Outcome|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633628|NCT02469597|O1|Outcome|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633629|NCT02469597|E2|Reported Event|Placebo|"Normal saline 1 dose~Placebo: 0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose"
633630|NCT02469597|E1|Reported Event|Single Dose of Furosemide|"Furosemide 1 dose~Furosemide: 1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose"
633631|NCT02469116|B1|Baseline|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633632|NCT02469116|P1|Participant Flow|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633633|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633634|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633635|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633636|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633637|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633638|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633639|NCT02469116|O1|Outcome|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633640|NCT02469116|E1|Reported Event|Arm 1: (Docetaxel, Carboplatin, Pegylated G-CSF)|"Docetaxel intravenously over 1 hour followed by carboplatin intravenously over 30 minutes-1 hour on day 1 every 21 days for maximum of 6 cycles~Pegylated G-CSF on day 2 every 21 days for maximum of 6 cycles"
633641|NCT02468154|B3|Baseline|Total|Total of all reporting groups
633642|NCT02468154|B2|Baseline|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
633643|NCT02468154|B1|Baseline|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
633644|NCT02468154|P2|Participant Flow|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
633645|NCT02468154|P1|Participant Flow|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
633646|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
633647|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
633648|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
633649|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
633650|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
633651|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
633652|NCT02468154|O2|Outcome|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
633653|NCT02468154|O1|Outcome|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
633654|NCT02468154|E2|Reported Event|Standard Care|"To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane~standard off-load plaster cast: To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane"
633655|NCT02468154|E1|Reported Event|Splint|"Splint is placed under the cast of children affected by spasticity who have to keep the heel unloaded.~custom made splint: Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs."
633656|NCT02467777|B3|Baseline|Total|Total of all reporting groups
633657|NCT02467777|B2|Baseline|Conductive Warming|"VitaHeat~VitaHeat"
633658|NCT02467777|B1|Baseline|Forced Air|"Bair Hugger~Bair Hugger"
633659|NCT02467777|P2|Participant Flow|Conductive Warming|"VitaHeat~VitaHeat"
633660|NCT02467777|P1|Participant Flow|Forced Air|"Bair Hugger~Bair Hugger"
633661|NCT02467777|O2|Outcome|Conductive Warming|"VitaHeat~VitaHeat"
633665|NCT02467491|B1|Baseline|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633666|NCT02467491|P1|Participant Flow|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633667|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633668|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633669|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633670|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633671|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633672|NCT02467491|O1|Outcome|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633673|NCT02467491|E1|Reported Event|Physical Activity Group|"All the participants enrolled in the study will be part of the physical activity group in which they will perform a scheduled exercise program for 4 weeks using a new physical activity technology called Jintronix.~Jintronix: The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity."
633674|NCT02466425|B3|Baseline|Total|Total of all reporting groups
633675|NCT02466425|B2|Baseline|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
633676|NCT02466425|B1|Baseline|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
633677|NCT02466425|P2|Participant Flow|SHP465|Participants received SHP465 capsule (12.5 milligram [mg] during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
633678|NCT02466425|P1|Participant Flow|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
633679|NCT02466425|O2|Outcome|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
633680|NCT02466425|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
633681|NCT02466425|O2|Outcome|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during the dose maintenance phase) orally once daily for 4 weeks.
633682|NCT02466425|O1|Outcome|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
633683|NCT02466425|E2|Reported Event|SHP465|Participants received SHP465 capsule (12.5 mg during dose optimization and 25 mg during dose maintenance phase) orally once daily for 4 weeks.
633684|NCT02466425|E1|Reported Event|Placebo|Participants received placebo matched to SHP465 capsule orally once daily for 4 weeks.
633685|NCT02466412|B3|Baseline|Total|Total of all reporting groups
633686|NCT02466412|B2|Baseline|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
633687|NCT02466412|B1|Baseline|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
633688|NCT02466412|P2|Participant Flow|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
633689|NCT02466412|P1|Participant Flow|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
633690|NCT02466412|O2|Outcome|Menthol Cigarette (mCC)|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
633691|NCT02466412|O1|Outcome|CHTP 1.1 M|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
633692|NCT02466412|O2|Outcome|Menthol Cigarette (mCC)|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of mCC.
633693|NCT02466412|O1|Outcome|CHTP 1.1 M|The geometric least square mean presented below takes into consideration the data of all the subjects included in the PK population after single use of CHTP 1.1 M.
633694|NCT02466412|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the CHTP 1.1 M at Admission but were not randomized in 1 of the 2 sequences as they were back-up subjects
633695|NCT02466412|E2|Reported Event|mCC Then CHTP 1.1 M|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of CHTP 1.1 M)."
633696|NCT02466412|E1|Reported Event|CHTP 1.1 M Then mCC|"Each subject will follow the below study design:~Day -1 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CHTP 1.1 M)~Day 2 = Wash-out~Day 3 = 2nd intervention (single product use of mCC)."
633697|NCT02465866|B1|Baseline|Overall Subjects|
633698|NCT02465866|P4|Participant Flow|Sequence 4: DACB|"Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Dosing in 4 study periods was separated by a 14-day washout period"
633699|NCT02465866|P3|Participant Flow|Sequence 3: CDBA|"Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Dosing in 4 study periods was separated by a 14-day washout period"
633700|NCT02465866|P2|Participant Flow|Sequence 2: BCAD|"Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Dosing in 4 study periods was separated by a 14-day washout period"
633701|NCT02465866|P1|Participant Flow|Sequence 1: ABDC|"Treatment A: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition~Treatment B: CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition~Treatment D: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition~Treatment C: Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition~Dosing in 4 study periods was separated by a 14-day washout period"
633702|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633703|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633704|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633705|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633706|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633707|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633708|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633709|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633710|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633711|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633712|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633713|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633714|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633715|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633716|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633717|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633718|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633719|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633720|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633721|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633722|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633723|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633724|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633725|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633726|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633727|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633728|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633729|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633730|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633731|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633732|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633733|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633734|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633735|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633736|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633737|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633738|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633739|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633740|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633741|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633742|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633743|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633744|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633745|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633746|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633747|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633748|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633749|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633750|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633751|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633752|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633753|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633754|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633755|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633756|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633757|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633758|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633759|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633760|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633761|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633762|NCT02465866|O4|Outcome|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633763|NCT02465866|O3|Outcome|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633764|NCT02465866|O2|Outcome|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633765|NCT02465866|O1|Outcome|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633766|NCT02465866|E4|Reported Event|Treatment D: Vicoprofen, Ultracet and Phenergan (Fed)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fed condition
633767|NCT02465866|E3|Reported Event|Treatment C: Vicoprofen, Ultracet and Phenergan (Fasted)|Vicoprofen 7.5 mg/200 mg + Ultracet 37.5 mg/325 mg + Phenergan 12.5 mg single dose tablets by mouth under fasted condition
633768|NCT02465866|E2|Reported Event|Treatment B: CL-108 (Fed)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fed condition
633769|NCT02465866|E1|Reported Event|Treatment A: CL-108 (Fasted)|CL-108 single dose tablet (7.5 mg/325 mg/12.5 mg) by mouth under fasted condition
633770|NCT02465489|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive five treatments in different orders:~deferiprone ER tablets under fasting conditions~deferiprone ER tablets under fed conditions~deferiprone ER tablets administered as half-tablets under fed conditions~Ferriprox IR tablets under fasting conditions~Ferriprox IR tablets under fed conditions"
633771|NCT02465489|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following five treatments in different orders, with a 7-day washout period between treatments::~A: Deferiprone ER tablets under fasting conditions B: Deferiprone ER tablets under fed conditions C: Deferiprone ER tablets administered as half-tablets under fed conditions D: Ferriprox IR tablets under fasting conditions E: Ferriprox IR tablets under fed conditions~The sequences were as follows;~Sequence 1 (n=4): A-B-E-C-D~Sequence 2 (n=4): B-C-A-D-E~Sequence 3 (n=4): C-D-B-E-A~Sequence 4 (n=4): D-E-C-A-B~Sequence 5 (n=4): E-A-D-B-C"
633772|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633773|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633774|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633775|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633776|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633777|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633778|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633779|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633780|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633781|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633782|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633783|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633784|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633978|NCT02457611|E1|Reported Event|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633785|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633786|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633787|NCT02465489|O5|Outcome|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633788|NCT02465489|O4|Outcome|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633789|NCT02465489|O3|Outcome|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633790|NCT02465489|O2|Outcome|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633791|NCT02465489|O1|Outcome|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633792|NCT02465489|E5|Reported Event|Immediate Release, Fed Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a high-fat breakfast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633793|NCT02465489|E4|Reported Event|Immediate Release, Fasting Conditions|"A single 1000 mg dose of Ferriprox immediate release tablet formulation administered following a 10-hour fast~Deferiprone immediate release: Ferriprox (deferiprone) 500 mg immediate release tablet formulation"
633794|NCT02465489|E3|Reported Event|Extended Release Half-tablets, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation (one 1000 mg tablet divided in two) administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633795|NCT02465489|E2|Reported Event|Extended Release, Fed Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a high-fat breakfast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633796|NCT02465489|E1|Reported Event|Extended Release, Fasting Conditions|"A single 1000 mg dose of deferiprone extended release tablet formulation administered following a 10-hour fast~Deferiprone extended release: Deferiprone 1000 mg extended release tablet formulation"
633797|NCT02465073|B4|Baseline|Total|Total of all reporting groups
633798|NCT02465073|B3|Baseline|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
633799|NCT02465073|B2|Baseline|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
633800|NCT02465073|B1|Baseline|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
633801|NCT02465073|P3|Participant Flow|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
633802|NCT02465073|P2|Participant Flow|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
633803|NCT02465073|P1|Participant Flow|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
633804|NCT02465073|O3|Outcome|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
633805|NCT02465073|O2|Outcome|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
633806|NCT02465073|O1|Outcome|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
633807|NCT02465073|E3|Reported Event|Standard of Care|"This group will receive Standard of Care only.~Standard of Care Group: Subjects will receive Standard of Care only."
633808|NCT02465073|E2|Reported Event|NXTSC Plus SOC|"This group will receive the NXTSC wound gel plus Standard of Care.~NXTSC wound gel plus Standard of Care: Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only."
633809|NCT02465073|E1|Reported Event|NXTSC|"This group will receive the NXTSC gel only.~NXTSC wound gel: Subjects will receive NXTSC wound gel only."
633810|NCT02463409|B1|Baseline|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
633811|NCT02463409|P1|Participant Flow|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
633812|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
633813|NCT02463409|O1|Outcome|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
633814|NCT02463409|E1|Reported Event|Theophylline|"Patients will receive a 24 hour continuous infusion of intravenous theophylline.~Theophylline: 24 hour infusion of IV theophylline"
633815|NCT02463331|B3|Baseline|Total|Total of all reporting groups
633816|NCT02463331|B2|Baseline|Azathioprine Plus Prednisone|"azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
633900|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633817|NCT02463331|B1|Baseline|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
633818|NCT02463331|P2|Participant Flow|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
633819|NCT02463331|P1|Participant Flow|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
633820|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
633821|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
633822|NCT02463331|O2|Outcome|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
633823|NCT02463331|O1|Outcome|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
633824|NCT02463331|E2|Reported Event|Azathioprine Plus Prednisone|"azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses~prednisone: Prednisone 5-15 mg/day until the end of the study~azathioprine: azathioprine 1-2mg/Kg/day until the end of the study"
633825|NCT02463331|E1|Reported Event|Chloroquine Plus Prednisone|"Chloroquine diphosphate 250mg/day associated to prednisone in variable doses~Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study~prednisone: Prednisone 5-15 mg/day until the end of the study"
633826|NCT02463227|B1|Baseline|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633827|NCT02463227|P1|Participant Flow|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633828|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633829|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633830|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633831|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633832|NCT02463227|O1|Outcome|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633833|NCT02463227|E1|Reported Event|VRC01|"Participants received an IV infusion of 40 mg/kg of VRC01 on study days 0, 21, and 42.~VRC01: 40 mg/kg of VRC01 administered IV in 100 mL of 0.9% sodium chloride for injection, USP.~Administered over about 30 to 60 minutes using a volumetric pump."
633834|NCT02463097|B1|Baseline|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
633835|NCT02463097|P1|Participant Flow|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
633836|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
633837|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
633838|NCT02463097|O1|Outcome|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
633839|NCT02463097|E1|Reported Event|Study Arm|"All subjects wearing the MMT-670G insulin pump, using it with the closed loop algorithm~Insulin Pump: Closed Loop Algorithm~i-STAT blood testing: Intravenous i-STAT blood testing is used for reference validation~Blood Glucose Meter testing: Frequent finger stick blood glucose testing using a Blood Glucose meter is required"
633840|NCT02462473|B1|Baseline|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633841|NCT02462473|P1|Participant Flow|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633842|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633843|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633844|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633845|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633846|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633847|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633848|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633849|NCT02462473|O1|Outcome|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633850|NCT02462473|E1|Reported Event|Cohort 1|Participants received treatment as usual (TAU) which include one or more of the 5 antipsychotic medications (aripiprazole, olanzapine, paliperidone, quetiapine, and risperidone) for 12 weeks.
633851|NCT02462291|B3|Baseline|Total|Total of all reporting groups
633852|NCT02462291|B2|Baseline|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
633853|NCT02462291|B1|Baseline|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633854|NCT02462291|P2|Participant Flow|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
633855|NCT02462291|P1|Participant Flow|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633856|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633857|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633858|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633859|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633860|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633861|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633862|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633863|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633864|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633865|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633866|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633867|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633868|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633869|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633870|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
633979|NCT02457247|B5|Baseline|Total|Total of all reporting groups
635565|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
633871|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633872|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633873|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633874|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
633875|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633876|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
633877|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633878|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD was treated with the standard therapy.
633879|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633880|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
633881|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633882|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
633883|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633884|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
633885|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633886|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
633887|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633888|NCT02462291|O2|Outcome|Control Group (CTRL)|A group of 81 patients with AD were treated with the standard therapy.
633889|NCT02462291|O1|Outcome|Experimental Group (TR)|"A group of 82 patients with AD performed a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633890|NCT02462291|E2|Reported Event|Control Group (CTRL)|A group of 81 patients with AD will be treated with the standard therapy.
633891|NCT02462291|E1|Reported Event|Experimental Group (TR)|"A group of 82 patients with AD will perform a program of EET for 2 hours a day, 5 days a week for a total of 6 months.~Ecological Environmental therapy: The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD."
633892|NCT02461992|B1|Baseline|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633893|NCT02461992|P1|Participant Flow|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633894|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633895|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633896|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633897|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633898|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633899|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633901|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633902|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633903|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633904|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633905|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633906|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633907|NCT02461992|O1|Outcome|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633908|NCT02461992|E1|Reported Event|Xyntha 50 IU/kg|Participants were administered a single dose of recombinant antihemophilic factor (Xyntha) at 50 international units per kilogram (IU/kg) infused intravenously over 10 minutes.
633909|NCT02461290|B1|Baseline|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
633910|NCT02461290|P1|Participant Flow|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated follicular lymphoma (FL) received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included cyclophosphamide, vincristine, and prednisone (CVP); cyclophosphamide, doxorubin, vincristine, and predisone (CHOP); or fludarabine, cyclophosphamide, and mitoxantrone (FCM). Rituximab was administered as 375 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
633911|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
633912|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
633913|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
633914|NCT02461290|O1|Outcome|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
633915|NCT02461290|E1|Reported Event|Rituximab + Chemotherapy|Participants with Stage III or IV, previously untreated FL received rituximab in combination with chemotherapy, which was prescribed in accordance with local labeling and standard practice at the study site. Chemotherapy regimens included CVP, CHOP, or FCM. Rituximab was administered as 375 mg/m^2 via IV infusion on Day 1 of each 21-day cycle for 8 cycles of induction therapy. Because the study was noninterventional, the rituximab regimen was also at the discretion of the prescribing physician.
633916|NCT02460822|B1|Baseline|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633917|NCT02460822|P1|Participant Flow|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633938|NCT02458768|E2|Reported Event|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
633918|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633919|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633920|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633921|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633922|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633923|NCT02460822|O1|Outcome|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633924|NCT02460822|E1|Reported Event|MyChemoCare|"Participants will receive access to the the MyChemoCare iPad application, which allows them to track cancer and chemotherapy related symptoms daily, and suggests strategies that may help the participant deal with these symptoms. While using the application, high symptom severity scores will be reported to the participant's medical team, who may intervene to help relieve the symptom. Participants will also be contacted if they have not checked in for 48 hours to make sure they are coping well with their chemotherapy regimen.~MyChemoCare iPad application"
633925|NCT02460458|B1|Baseline|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
633926|NCT02460458|P1|Participant Flow|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
633927|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
633928|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
633929|NCT02460458|O1|Outcome|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
633930|NCT02460458|E1|Reported Event|Type 3 VWD|Diagnosis of Type 3 von Willebrand Disease
633931|NCT02458768|B3|Baseline|Total|Total of all reporting groups
633932|NCT02458768|B2|Baseline|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
633933|NCT02458768|B1|Baseline|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
633934|NCT02458768|P2|Participant Flow|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
633935|NCT02458768|P1|Participant Flow|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
633936|NCT02458768|O2|Outcome|Menopur® Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~Menopur® Inj."
633937|NCT02458768|O1|Outcome|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
633974|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
635566|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
633939|NCT02458768|E1|Reported Event|IVF-M HP Inj.|"Administration was initiated on the mean menstrual cycle day (MCD) 2 or 3 and made by subcutaneous injection.~Although the recommended initial dose of Investigational Product (IP) was 225 IU, adjustment was allowed according to the patient's individual response based on the monitoring (blood estradiol (E2) concentration and ultrasonography results).~IVF-M HP Inj."
633940|NCT02458365|B3|Baseline|Total|Total of all reporting groups
633941|NCT02458365|B2|Baseline|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633942|NCT02458365|B1|Baseline|Intevention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633943|NCT02458365|P2|Participant Flow|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633944|NCT02458365|P1|Participant Flow|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633945|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633946|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633947|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633948|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633949|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633950|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633951|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633952|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633975|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633976|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633953|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633954|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633955|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633956|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633957|NCT02458365|O2|Outcome|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633958|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633959|NCT02458365|O2|Outcome|Comparison: Health in Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633960|NCT02458365|O1|Outcome|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633961|NCT02458365|E2|Reported Event|Comparison: Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
633962|NCT02458365|E1|Reported Event|Intervention: Teen Choices|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
633963|NCT02457728|B1|Baseline|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TransAbdominalPrePeritoneal (TAPP) repair."
633964|NCT02457728|P1|Participant Flow|Inguinal Herniation|"In patients with bilateral herniations it should be explored if one glue device (LiquiBandFix8) for mesh fixation and closure of peritoneum is sufficient.~LiquiBandFix8: Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair."
633965|NCT02457728|O1|Outcome|Single-port TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair using a single-port approach.
633966|NCT02457728|E1|Reported Event|TAPP Repair|LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
633967|NCT02457611|B1|Baseline|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633968|NCT02457611|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered once daily for 6 weeks
633969|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633970|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633971|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633972|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633973|NCT02457611|O1|Outcome|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered once daily for 6 weeks
633980|NCT02457247|B4|Baseline|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
633981|NCT02457247|B3|Baseline|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
633982|NCT02457247|B2|Baseline|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
633983|NCT02457247|B1|Baseline|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
633984|NCT02457247|P4|Participant Flow|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
633985|NCT02457247|P3|Participant Flow|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
633986|NCT02457247|P2|Participant Flow|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
633987|NCT02457247|P1|Participant Flow|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
633988|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
633989|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
633990|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
633991|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
633992|NCT02457247|O4|Outcome|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
633993|NCT02457247|O3|Outcome|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
633994|NCT02457247|O2|Outcome|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
633995|NCT02457247|O1|Outcome|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
633996|NCT02457247|O6|Outcome|Test Group 2: Total|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, for 14 days in either Period 1 or 2 and Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, for 14 days in either Period 1 or 2.
633997|NCT02457247|O5|Outcome|Test Group 1: Total|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2 and Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, for 14 days in either Period 1 or 2.
633998|NCT02457247|O4|Outcome|Test Group 2: Sequence DC|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14, followed by, Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 15 through 28.
633999|NCT02457247|O3|Outcome|Test Group 2: Sequence CD|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14, followed by Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3) [D], chewable tablets, orally, once, daily, on Days 15 through 28.
634000|NCT02457247|O2|Outcome|Test Group 1: Sequence BA|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14, followed by, Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 15 through 28.
634001|NCT02457247|O1|Outcome|Test Group 1: Sequence AB|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14, followed by Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3) [B], chewable tablets, orally, twice, daily, on Days 15 through 28.
634002|NCT02457247|E4|Reported Event|Germany: Kalcipos-D|Kalcipos-D (Calcium 500 mg/800 IU Vitamin D3), chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
634003|NCT02457247|E3|Reported Event|Germany: Calcichew D3 500/800|Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3) [C], chewable tablets, orally, once, daily, on Days 1 through 14 or Days 15 through 28.
634004|NCT02457247|E2|Reported Event|United Kingdom: Adcal-D3|Adcal-D3 (Calcium 600 mg / 400 IU Vitamin D3), chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
634005|NCT02457247|E1|Reported Event|United Kingdom: Calcichew D3 500/400|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) [A], chewable tablets, orally, twice, daily, on Days 1 through 14 or Days 15 through 28.
634006|NCT02455050|B5|Baseline|Total|Total of all reporting groups
634007|NCT02455050|B4|Baseline|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634147|NCT02454127|P2|Participant Flow|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634008|NCT02455050|B3|Baseline|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634009|NCT02455050|B2|Baseline|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634010|NCT02455050|B1|Baseline|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634011|NCT02455050|P4|Participant Flow|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634012|NCT02455050|P3|Participant Flow|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634013|NCT02455050|P2|Participant Flow|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634014|NCT02455050|P1|Participant Flow|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634015|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634016|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634017|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634018|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634019|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634020|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634021|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634022|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634023|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634024|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634025|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634026|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634027|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634028|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634029|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634030|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634031|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634032|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634033|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634034|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634035|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634036|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634037|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634038|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634039|NCT02455050|O1|Outcome|New Eye Drop Formulation and Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Genteal® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634040|NCT02455050|O1|Outcome|New Eye Drop Formulation and Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2 and 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634041|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634042|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634043|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634044|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634045|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634046|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634047|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634048|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634049|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634050|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634051|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634052|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634053|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634054|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634055|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634056|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634057|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634058|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634059|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634060|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634061|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634062|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 or 2.
634063|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634064|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634065|NCT02455050|O4|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634066|NCT02455050|O3|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634067|NCT02455050|O2|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634068|NCT02455050|O1|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634069|NCT02455050|O4|Outcome|Genteal®|1 to 2 drops Genteal® Lubricant Gel drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
634070|NCT02455050|O3|Outcome|New Eye Drop Formulation (Genteal® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
634071|NCT02455050|O2|Outcome|Systane®|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1.
634072|NCT02455050|O1|Outcome|New Eye Drop Formulation (Systane® Group)|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1.
634148|NCT02454127|P1|Participant Flow|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
640270|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
634073|NCT02455050|E4|Reported Event|Genteal® Then New Eye Drop Formulation|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634074|NCT02455050|E3|Reported Event|New Eye Drop Formulation Then Genteal®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634075|NCT02455050|E2|Reported Event|Systane® Then New Eye Drop Formulation|1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634076|NCT02455050|E1|Reported Event|New Eye Drop Formulation Then Systane®|1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks in Period 1 followed by 1 to 2 drops of Systane® in each eye as needed at least 2 times daily for 2 weeks in Period 2.
634077|NCT02454959|B1|Baseline|MITT Population|The Modified ITT (MITT) Population is a subset of the ITT Population including subjects who received treatment and had post dose efficacy data from both Treatment Periods. Data judged to be impacted by major protocol deviations were determined prior to unblinding and excluded. Statistical tabulations and analyses are by randomized treatment, but data obtained after subjects received an incorrect treatment have been excluded from the affected periods.
634078|NCT02454959|P1|Participant Flow|Overall Study|All Randomized Patients
634079|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634080|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634081|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634082|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634083|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634084|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634085|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634086|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634087|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634088|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634089|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634090|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634091|NCT02454959|O2|Outcome|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634092|NCT02454959|O1|Outcome|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634093|NCT02454959|E2|Reported Event|GFF MDI (PT003) Without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID without Aerochamber Plus Valved Holding Chamber
634094|NCT02454959|E1|Reported Event|GFF MDI (PT003) With Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003 (GFF MDI) 14.4/9.6 µg BID with Aerochamber Plus Valved Holding Chamber
634095|NCT02454608|B3|Baseline|Total|Total of all reporting groups
634096|NCT02454608|B2|Baseline|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634097|NCT02454608|B1|Baseline|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634098|NCT02454608|P2|Participant Flow|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634149|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634150|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634151|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634152|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634153|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634099|NCT02454608|P1|Participant Flow|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634100|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634101|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634102|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634103|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634104|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634105|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634106|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634107|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634108|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634109|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634110|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634111|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634112|NCT02454608|O2|Outcome|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634154|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634155|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634156|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
635567|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
634113|NCT02454608|O1|Outcome|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634114|NCT02454608|E2|Reported Event|Control|"Placebo, capsules for oral administration, TID, for 8 weeks~Placebo: Capsule with the same characteristics (size, color, smell) as Verapamil HCl."
634115|NCT02454608|E1|Reported Event|Treatment|"Verapamil HCl, capsules for oral administration, 80mg, TID, for 8 weeks~Verapamil HCl: Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps."
634116|NCT02454296|B3|Baseline|Total|Total of all reporting groups
634117|NCT02454296|B2|Baseline|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
634118|NCT02454296|B1|Baseline|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
634119|NCT02454296|P2|Participant Flow|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
634120|NCT02454296|P1|Participant Flow|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
634121|NCT02454296|O2|Outcome|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
634122|NCT02454296|O1|Outcome|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
634123|NCT02454296|O2|Outcome|Sham Block Group|Participants in this arm had a 20 ml syringe with a capped needle applied to the cervix.
634124|NCT02454296|O1|Outcome|Paracervical Block Group|Participants in this arm received a paracervical block consisting of 18 ml 1% lidocaine and 2 ml 8.4% sodium bicarbonate prior to the placement of laminaria.
634125|NCT02454296|O2|Outcome|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
634126|NCT02454296|O1|Outcome|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
634127|NCT02454296|E2|Reported Event|Sham Paracervical Block|"A sham block will be done prior to the placement of laminaria using a capped needle~Sham paracervical block: A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes"
634128|NCT02454296|E1|Reported Event|Paracervical Block With Lidocaine|"A paracervical block will be done prior to the placement of laminaria with 1% lidocaine and sodium bicarbonate.~Paracervical Block with lidocaine: Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion"
634129|NCT02454283|B3|Baseline|Total|Total of all reporting groups
634130|NCT02454283|B2|Baseline|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
634131|NCT02454283|B1|Baseline|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
634132|NCT02454283|P2|Participant Flow|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
634133|NCT02454283|P1|Participant Flow|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
634134|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
634135|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
634136|NCT02454283|O2|Outcome|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
634137|NCT02454283|O1|Outcome|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
634138|NCT02454283|E2|Reported Event|Placebo|"identically matching placebo capsules, orally, single-dose~Placebo"
634139|NCT02454283|E1|Reported Event|Vanoxerine HCl|"Vanoxerine HCl, 400 mg (2 x 200 mg capsules), orally, single dose~Vanoxerine HCl"
634140|NCT02454127|B5|Baseline|Total|Total of all reporting groups
634141|NCT02454127|B4|Baseline|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634142|NCT02454127|B3|Baseline|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634143|NCT02454127|B2|Baseline|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634144|NCT02454127|B1|Baseline|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634145|NCT02454127|P4|Participant Flow|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634146|NCT02454127|P3|Participant Flow|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634157|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634158|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634159|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634160|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634161|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634162|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634163|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634164|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634165|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634166|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634167|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634168|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634169|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634170|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634171|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634172|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634173|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634174|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634175|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634176|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634177|NCT02454127|O4|Outcome|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634178|NCT02454127|O3|Outcome|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634179|NCT02454127|O2|Outcome|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634180|NCT02454127|O1|Outcome|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634181|NCT02454127|E4|Reported Event|Ornish Diet|"Ornish Diet (dietary counseling)~Ornish Diet: Dietary counseling for 1 year"
634182|NCT02454127|E3|Reported Event|Weight Watchers Diet|"Weight Watchers Diet (dietary counseling)~Weight Watchers Diet: Dietary counseling for 1 year"
634183|NCT02454127|E2|Reported Event|Zone Diet|"Zone Diet (dietary counseling)~Zone Diet: Dietary counseling for 1 year"
634184|NCT02454127|E1|Reported Event|Atkins Diet|"Atkins Diet (dietary counseling)~Atkins Diet: Dietary counseling for 1 year"
634185|NCT02454101|B3|Baseline|Total|Total of all reporting groups
634186|NCT02454101|B2|Baseline|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634187|NCT02454101|B1|Baseline|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634188|NCT02454101|P2|Participant Flow|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634189|NCT02454101|P1|Participant Flow|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634190|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634191|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634192|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634193|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634194|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634195|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634196|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634197|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634198|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634199|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634200|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634201|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634202|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634203|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634204|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634205|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634206|NCT02454101|O2|Outcome|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634207|NCT02454101|O1|Outcome|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634208|NCT02454101|E2|Reported Event|Delayed Cord Clamping|"delayed cord clamping for 120 seconds~cord milking: milking of the cord 5 times toward the neonate"
634209|NCT02454101|E1|Reported Event|Cord Milking|"milking of the umbilical cord 5 times toward the neonate~delayed cord clamping: delay clamping of the cord for 120 seconds"
634210|NCT02453581|B1|Baseline|Randomised Participants|Twenty-four male and female subjects were enrolled in the study.
634211|NCT02453581|P3|Participant Flow|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
634212|NCT02453581|P2|Participant Flow|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
634213|NCT02453581|P1|Participant Flow|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
634214|NCT02453581|O1|Outcome|OZ439 500mg Arm|Cohort 3 - OZ439 500mg
634215|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
634216|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
634217|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
634218|NCT02453581|O3|Outcome|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
634219|NCT02453581|O2|Outcome|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
634220|NCT02453581|O1|Outcome|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
634221|NCT02453581|O8|Outcome|OZ439 500mg - R024|Cohort 3 - OZ439 500mg - Subject R024
634222|NCT02453581|O7|Outcome|OZ439 500mg - R023|Cohort 3 - OZ439 500mg - Subject R023
634223|NCT02453581|O6|Outcome|OZ439 500mg - R022|Cohort 3 - OZ439 500mg - Subject R022
634224|NCT02453581|O5|Outcome|OZ439 500mg - R021|Cohort 3 - OZ439 500mg - Subject R021
634225|NCT02453581|O4|Outcome|OZ439 500mg - R020|Cohort 3 - OZ439 500mg - Subject R020
634226|NCT02453581|O3|Outcome|OZ439 500mg - R019|Cohort 3 - OZ439 500mg - Subject R019
634227|NCT02453581|O2|Outcome|OZ439 500mg - R018|Cohort 3 - OZ439 500mg - Subject R018
634228|NCT02453581|O1|Outcome|OZ439 500mg - R017|Cohort 3 - OZ439 500mg - Subject R017
634229|NCT02453581|E3|Reported Event|OZ439 500mg|OZ439 500mg Powder for Oral Suspension
634230|NCT02453581|E2|Reported Event|OZ439 200mg|OZ439 200mg Powder for Oral Suspension
634231|NCT02453581|E1|Reported Event|OZ439 100mg|OZ439 100mg Powder for Oral Suspension
634232|NCT02452944|B3|Baseline|Total|Total of all reporting groups
634233|NCT02452944|B2|Baseline|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics was injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
634234|NCT02452944|B1|Baseline|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
634235|NCT02452944|P2|Participant Flow|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group)~The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA;1.5% lidocaine + epi 1:200,000) were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected."
634236|NCT02452944|P1|Participant Flow|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis muscles. 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator for confirming the block. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’."
634237|NCT02452944|O2|Outcome|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
634262|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634263|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634264|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634265|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634266|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634238|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
634239|NCT02452944|O2|Outcome|US-NS Group|"ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided m"
634240|NCT02452944|O1|Outcome|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerv"
634241|NCT02452944|E2|Reported Event|US-NS Group|ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis muscles. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
634242|NCT02452944|E1|Reported Event|US-IFI Group|"ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)~The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.~After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as ‘fail’.~nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block~ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run."
634243|NCT02451150|B3|Baseline|Total|Total of all reporting groups
634244|NCT02451150|B2|Baseline|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634245|NCT02451150|B1|Baseline|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634246|NCT02451150|P2|Participant Flow|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634247|NCT02451150|P1|Participant Flow|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634248|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634249|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634250|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634251|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634252|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634253|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634254|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634255|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634256|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634257|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634258|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634259|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634260|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634261|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
635568|NCT02429258|E2|Reported Event|Placebo|Placebo + Metformin or Insulin
634267|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634268|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634269|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634270|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634271|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634272|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634273|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634274|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634275|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634276|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634277|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634278|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634279|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634280|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634281|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634282|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634283|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634284|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634285|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634286|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634287|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634288|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634289|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634290|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634291|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634292|NCT02451150|O2|Outcome|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634293|NCT02451150|O1|Outcome|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634294|NCT02451150|E2|Reported Event|Azilsartan 10 mg|Weight ≥50 kg: azilsartan 10 mg, tablets, orally, once, after breakfast on Day 1.
634295|NCT02451150|E1|Reported Event|Azilsartan 5 mg|Weight <50 kg: azilsartan 5 mg, tablets, orally, once, after breakfast on Day 1.
634296|NCT02450799|B4|Baseline|Total|Total of all reporting groups
634297|NCT02450799|B3|Baseline|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
634298|NCT02450799|B2|Baseline|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
634299|NCT02450799|B1|Baseline|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
634300|NCT02450799|P3|Participant Flow|PMMA|Polymethylmethacrylate (PMMA) IOL, prior implantation (1994-2000) in one or both eyes
634301|NCT02450799|P2|Participant Flow|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
634302|NCT02450799|P1|Participant Flow|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
634303|NCT02450799|O3|Outcome|PMMA|Polymethylmethacrylate IOL, prior implantation (1994-2000) in one or both eyes
634304|NCT02450799|O2|Outcome|Silicone|Silicone IOL, prior implantation (1994-2000) in one or both eyes
634305|NCT02450799|O1|Outcome|AcrySof|Acrylic IOL, prior implantation (1994-2000) in one or both eyes
634306|NCT02450799|E6|Reported Event|PMMA (Prospective)|Subjects with prior implantation of PMMA IOL who experienced an AE with onset after the Informed Consent acquisition
634307|NCT02450799|E5|Reported Event|Silicone (Prospective)|Subjects with prior implantation of Silicone IOL who experienced an AE with onset after the Informed Consent acquisition
634308|NCT02450799|E4|Reported Event|AcrySof (Prospective)|Subjects with prior implantation of acrylic IOL who experienced an AE with onset after the Informed Consent acquisition
634309|NCT02450799|E3|Reported Event|PMMA (Retrospective)|Subjects with prior implantation of PMMA IOL who experienced an AE related to decrease of BCVA in the study eye
634310|NCT02450799|E2|Reported Event|Silicone (Retrospective)|Subjects with prior implantation of Silicone IOL who experienced an AE related to decrease of BCVA in the study eye
634311|NCT02450799|E1|Reported Event|AcrySof (Retrospective)|Subjects with prior implantation of acrylic IOL who experienced an AE related to decrease of BCVA in the study eye
634312|NCT02450747|B1|Baseline|Multi-focal(Etafilcon A)|All subjects wore the Test Contact Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
634313|NCT02450747|P1|Participant Flow|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
634314|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
634315|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
634316|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study Lens, Multi-focal (etafilcon A) as a daily wear modality over a period of four weeks.
634317|NCT02450747|O1|Outcome|Basline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
634318|NCT02450747|O2|Outcome|Multi-focal(Etafilcon A)|All subjects wore the study lens, Multi-focal (etafilcon A ) as daily wear modality over a period of four weeks.
634319|NCT02450747|O1|Outcome|Baseline|Measurements taken at baseline are on all subjects that had already been dispensed the study lens. Only baseline measurements from subject included in the analysis population was reported.
634320|NCT02450747|E1|Reported Event|Multi-focal(Etafilcon A)|All subjects worn the Test Contact Lens, Multi-focal (etafilcon A) as daily wear modality over a period of four weeks.
634321|NCT02449902|B3|Baseline|Total|Total of all reporting groups
634322|NCT02449902|B2|Baseline|Placebo Daily for 14 Days|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
634323|NCT02449902|B1|Baseline|Estradiol 10 μg Daily for 14 Days|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
634324|NCT02449902|P2|Participant Flow|Placebo|Control treatment group. Subjects self-administered the control treatment, a single placebo matching capsule, intravaginally once daily for 14 days.
634325|NCT02449902|P1|Participant Flow|TX-12-004-HR 10μg|Active treatment group. Subjects self-administered the active treatment, a single capsule of 10 μg Estradiol, intravaginally once daily for 14 days.
634326|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634327|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634328|NCT02449902|O2|Outcome|Treatment 2|"Placebo vaginal softgel capsule~placebo: 1 placebo capsule inserted vaginally for 14 days."
634329|NCT02449902|O1|Outcome|Treatment 1|"Estradiol 10 μg vaginal softgel capsule~Estradiol: 1 10 µg capsule inserted vaginally for 14 days."
634330|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634331|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634332|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634333|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634334|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634335|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634336|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634337|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634338|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634339|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634340|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634341|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634342|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634343|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634344|NCT02449902|O2|Outcome|Placebo|Control treatment group.
634345|NCT02449902|O1|Outcome|TX-12-004-HR 10μg|Active treatment group.
634346|NCT02449902|E2|Reported Event|Placebo|Control treatment group.
634347|NCT02449902|E1|Reported Event|TX-12-004-HR|Active treatment group.
634348|NCT02449798|B1|Baseline|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634349|NCT02449798|P1|Participant Flow|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 Blood Control (BC) peripheral intravenous (PIV) device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634350|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634351|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634352|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634353|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634354|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634381|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634355|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634356|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634357|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634358|NCT02449798|O1|Outcome|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634359|NCT02449798|E1|Reported Event|"AccuCath 2.25 BC Intravascular Catheter"|"Use of AccuCath 2.25 BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins.~AccuCath 2.25 BC Intravascular Catheter: Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance."
634360|NCT02449356|B3|Baseline|Total|Total of all reporting groups
634361|NCT02449356|B2|Baseline|Traditional Endotracheal Tube(TT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the traditional endotracheal tube group(TT), in which group the patients were intubated with the routine endotracheal tube.
634362|NCT02449356|B1|Baseline|Prone Position Endotracheal Tube(PPT)|We enrolled total 60 adult patients undergoing prone position ventilation surgery,and randomized to each group.30 subjects were involved in the prone position endotracheal tube group(PPT), in which group the patients were intubated with the custom-designed endotracheal tube.
634363|NCT02449356|P2|Participant Flow|Prone Position Endotracheal Tube(PPT)|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
634364|NCT02449356|P1|Participant Flow|Traditional Endotracheal Tube(TT)|the subjects of this arm are given the routine endotracheal tube.
634365|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
634366|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
634367|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
634368|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
634369|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
634370|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
634371|NCT02449356|O2|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
634372|NCT02449356|O1|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
634373|NCT02449356|O2|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
634374|NCT02449356|O1|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
634375|NCT02449356|O2|Outcome|the Traditional Endotracheal Tube|the subjects of this arm are given the routine endotracheal tube.
634376|NCT02449356|O1|Outcome|Prone Ventilation Endotracheal Tube|"the subjects of this arm are given the prone ventilation endotracheal tube which contains fixed device, fixed rope.~prone ventilation endotracheal tube: some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes"
634377|NCT02449356|E2|Reported Event|Traditional Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
634378|NCT02449356|E1|Reported Event|Prone Position Endotracheal Tube|there was one patient in this group occuring mild sore throat,and none occured dysphagia, dysphonia.
634379|NCT02449044|B1|Baseline|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634380|NCT02449044|P1|Participant Flow|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
640271|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
634382|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634383|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634384|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634385|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634386|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634387|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634388|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634389|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634390|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634391|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634392|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634393|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634394|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634395|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634396|NCT02449044|O1|Outcome|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634397|NCT02449044|E1|Reported Event|Tolvaptan|Participants received 15 mg tolvaptan QD and were titrated from 15mg, 30mg, or 60mg of tolvaptan based on the participant’s response in serum sodium concentration and clinical tolerance of study drug.
634398|NCT02448914|B1|Baseline|TRIGEL and Duodopa in Randomized Order|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone). Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634399|NCT02448914|P2|Participant Flow|Duodopa First, Then TRIGEL|"First Intervention (Day 1): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Second Intervention (Day 2): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634400|NCT02448914|P1|Participant Flow|TRIGEL First, Then Duodopa|"First Intervention (Day 1): TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~Second Intervention (Day 2): Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made. All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634401|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634402|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
634403|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634404|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
634405|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634406|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
634407|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634408|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
634409|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634410|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
634411|NCT02448914|O2|Outcome|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634412|NCT02448914|O1|Outcome|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study.~Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
634443|NCT02447458|P2|Participant Flow|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634413|NCT02448914|E2|Reported Event|Duodopa|"Duodopa, intestinal gel (20 mg/mL levodopa and 5 mg/mL carbidopa monohydrate).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~All Duodopa doses corresponded to 100% of the pre-study individually optimized doses of Duodopa."
634414|NCT02448914|E1|Reported Event|TRIGEL|"TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).~All patients received TRIGEL and Duodopa treatment on two consecutive days in the study. Both TRIGEL and Duodopa were administered during 14 h in total. Each treatment consisted of three individually adjusted and pre-defined doses: a morning dose, a continuous administration, and extra doses (if required).~The TRIGEL doses corresponded to 80% of the pre-study individually optimized doses of Duodopa in the first cohort of 5 patients. After the first cohort, a pre-planned interim analysis was performed. It was decided that the morning dose would be adjusted from 80% to 90% of the corresponding Duodopa dose for the second cohort. No other changes to the dosage regimens were made."
634415|NCT02448862|B3|Baseline|Total|Total of all reporting groups
634416|NCT02448862|B2|Baseline|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634417|NCT02448862|B1|Baseline|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634418|NCT02448862|P2|Participant Flow|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634419|NCT02448862|P1|Participant Flow|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634420|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634421|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634422|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634423|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634444|NCT02447458|P1|Participant Flow|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634445|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634424|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634425|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634426|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634427|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634428|NCT02448862|O2|Outcome|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634429|NCT02448862|O1|Outcome|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634430|NCT02448862|E2|Reported Event|Young Adults|"Patients aged 20 to 39 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634431|NCT02448862|E1|Reported Event|Elderly Patients|"Patients aged over 70 who had used fentanyl based IV-PCA for postoperative pain.~Fentanyl based IV-PCA: We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist’s option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs."
634432|NCT02447458|B7|Baseline|Total|Total of all reporting groups
634433|NCT02447458|B6|Baseline|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
634434|NCT02447458|B5|Baseline|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634435|NCT02447458|B4|Baseline|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634436|NCT02447458|B3|Baseline|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634437|NCT02447458|B2|Baseline|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634438|NCT02447458|B1|Baseline|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634439|NCT02447458|P6|Participant Flow|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
634440|NCT02447458|P5|Participant Flow|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634441|NCT02447458|P4|Participant Flow|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634442|NCT02447458|P3|Participant Flow|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
640272|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
634448|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634449|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634450|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634451|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634452|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634453|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634454|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634455|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634456|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634457|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634458|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634459|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634460|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634461|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634462|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634463|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634464|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634465|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634466|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634467|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634468|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634469|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634470|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634471|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634472|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634473|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634474|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634475|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634476|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634477|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634478|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634479|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634480|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634481|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634482|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634483|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634484|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634485|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634486|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634487|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634488|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634489|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634490|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634491|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634492|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634493|NCT02447458|O6|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634494|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634495|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
640273|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
634496|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634497|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634498|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634499|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634500|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634501|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
634502|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634503|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634504|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634505|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634506|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634507|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634508|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634509|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
634510|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634511|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634512|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634513|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634514|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634515|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634516|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634517|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
634518|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634519|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634520|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634521|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634522|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634523|NCT02447458|O8|Outcome|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634524|NCT02447458|O7|Outcome|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634525|NCT02447458|O6|Outcome|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
634526|NCT02447458|O5|Outcome|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634527|NCT02447458|O4|Outcome|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634528|NCT02447458|O3|Outcome|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634529|NCT02447458|O2|Outcome|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634530|NCT02447458|O1|Outcome|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634531|NCT02447458|E8|Reported Event|Placebo (Fed)|Placebo matching MLN3126 tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634532|NCT02447458|E7|Reported Event|MLN3126 1000 mg (Fed)|MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634533|NCT02447458|E6|Reported Event|Placebo|Placebo-matching MLN3126 tablets, orally, fasting, once on Day 1.
634534|NCT02447458|E5|Reported Event|MLN3126 2000 mg|MLN3126 2000 mg tablets, orally, fasting once on Day 1.
634535|NCT02447458|E4|Reported Event|MLN3126 1500 mg|MLN3126 1500 mg tablets, orally, fasting, once on Day 1.
634536|NCT02447458|E3|Reported Event|MLN3126 1000 mg|MLN3126 1000 mg tablets, orally, fasting, once on Day 1. Participants returned to the clinic then received MLN3126 1000 mg tablets, orally, fed (30 minutes after the start of a high-fat breakfast), once on Day 1.
634537|NCT02447458|E2|Reported Event|MLN3126 600 mg|MLN3126 600 mg tablets, orally, fasting, once on Day 1.
634538|NCT02447458|E1|Reported Event|MLN3126 300 mg|MLN3126 300 mg tablets, orally, fasting, once on Day 1.
634539|NCT02447432|B3|Baseline|Total|Total of all reporting groups
634540|NCT02447432|B2|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of Synflorix™ vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
634541|NCT02447432|B1|Baseline|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch 002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine : right thigh; DTPw-HBV/Hibvaccine : left thigh).
634542|NCT02447432|P2|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634543|NCT02447432|P1|Participant Flow|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634544|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634545|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634546|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634547|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634548|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634549|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634550|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634601|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634682|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634551|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634552|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634553|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634554|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634555|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634556|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634557|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634558|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634559|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634560|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634602|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634683|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634561|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634562|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634563|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634564|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634565|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634566|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634567|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634568|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634569|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634570|NCT02447432|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634603|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634684|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634571|NCT02447432|O1|Outcome|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634572|NCT02447432|E2|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the licensed 1-dose presentation 10Pn-PD-DiT (Synflorix™) vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 1-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634573|NCT02447432|E1|Reported Event|10Pn_4d Group|Healthy male or female subjects between, and including 6 to 10 weeks (42-76 days) of age at the time of first vaccination, received 3 doses of the investigational 4-dose presentation 10Pn-PD-DiT vaccine given approximatively at 6, 10 and 18 weeks of age (primary vaccination – Epoch 001) and 3 doses of DTPw-HBV/Hib vaccine given approximatively at 6, 10 and 14 weeks of age (according to the EPI schedule). They also received a booster dose of the 4-dose presentation 10Pn-PD-DiT vaccine at approximatively 9 months of age (Epoch-002). All vaccines were administered by intramuscular injection in the antero-lateral thigh (10Pn-PD-DiT vaccine: right thigh; DTPw-HBV/Hib vaccine: left thigh).
634574|NCT02447133|B1|Baseline|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
634575|NCT02447133|P1|Participant Flow|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
634576|NCT02447133|O3|Outcome|6x6 Disc Scan|TopQ of 6x6 Disc Scan
634577|NCT02447133|O2|Outcome|6x6 Macula Scan|TopQ of 6x6 Macular Scan
634578|NCT02447133|O1|Outcome|12x9 Wide Scan|TopQ of 12x9 Wide Scan
634579|NCT02447133|E1|Reported Event|Subjects Presenting With Normal Eyes|"Subjects with no known ocular diseases will be scanned on the Maestro device~3D OCT-1 Maestro: OCT Machine used for diagnostic purposes"
634580|NCT02446990|B3|Baseline|Total|Total of all reporting groups
634581|NCT02446990|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634582|NCT02446990|B1|Baseline|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634583|NCT02446990|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634584|NCT02446990|P1|Participant Flow|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634585|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634586|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634587|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634588|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634589|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634590|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634591|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634592|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634593|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634594|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634595|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634596|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634597|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634598|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634599|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634600|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634685|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634604|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634605|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634606|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634607|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634608|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634609|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634610|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634611|NCT02446990|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634612|NCT02446990|O1|Outcome|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634613|NCT02446990|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634614|NCT02446990|E1|Reported Event|Ivabradine|Ivabradine: 5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
634615|NCT02446613|B3|Baseline|Total|Total of all reporting groups
634616|NCT02446613|B2|Baseline|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634617|NCT02446613|B1|Baseline|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634618|NCT02446613|P2|Participant Flow|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 nanograms (ng), i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post NAC.
634619|NCT02446613|P1|Participant Flow|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to nasal allergen challenge (NAC) at Visit 2 to investigate the long term effect of matching placebo, intranasal (i.n.), administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 hours (h) post NAC.
634620|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634621|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634622|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
634623|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634624|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634625|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634626|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
634627|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634628|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym were recorded up to 6 h post-NAC.
640274|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
634629|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
634630|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
634631|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
634632|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym were recorded up to 6 h post-NAC.
634633|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634634|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958) . Total and individual nasal sym. were recorded up to 6 h post-NAC.
634635|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634636|NCT02446613|O2|Outcome|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634637|NCT02446613|O1|Outcome|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634638|NCT02446613|E2|Reported Event|GSK2245035 20 ng, i.n., Once Weekly|Participants were not administered with study medication in the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of GSK2245035 20 ng, i.n., once weekly received during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634639|NCT02446613|E1|Reported Event|Placebo Once Weekly|Participants were not administered with placebo during the current study (204509). Participants were subjected to NAC at Visit 2 to investigate the long term effect of matching placebo, i.n., administered once weekly during the parent study (TL7116958). Total and individual nasal sym. were recorded up to 6 h post-NAC.
634640|NCT02446496|B1|Baseline|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634641|NCT02446496|P1|Participant Flow|Treatment A-cefadroxil 1 gm + Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gram [gm] film coated [F.C.] tablet) or treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 ante meridiem (am) and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634642|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634643|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634644|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634645|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634646|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634647|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634648|NCT02446496|O2|Outcome|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634649|NCT02446496|O1|Outcome|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634650|NCT02446496|E2|Reported Event|Treatment B-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment B (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634651|NCT02446496|E1|Reported Event|Treatment A-cefadroxil 1 gm|In each period of the study, participants received one tablet of treatment A (cefadroxil 1 gm F.C. tablet), given with 240 ml water. Water was at room temperature and measured with a 250 ml cylinder according to a plan of randomization. The study drug administration took place between 09:00 am and 09:46 am for both periods in the morning of study Day 1 of each study period. A washout period of 7 days between the two study drug administrations was allowed.
634652|NCT02446483|B1|Baseline|Treatment A-rabeprazole 20 mg + Treatment B-rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) or treatment B (rabeprazole 20 mg gastro-resistant tablet), given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634653|NCT02446483|P2|Participant Flow|Treatment B-rabeprazole 20mg,Then Treatment A-rabeprazole 20mg|Participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment A (rabeprazole 20 mg enteric coated tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period.
634654|NCT02446483|P1|Participant Flow|Treatment A-rabeprazole 20mg,Then Treatment B-rabeprazole 20mg|Participants received one tablet of treatment A (rabeprazole 20 milligram [mg] enteric coated tablet) given with 240 milliliter (mL) water according to a plan of randomization. Water was at room temperature and measured with a 250 mL cylinder. After a washout period of 7 days, participants then received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) given with 240 mL water. Participants were admitted the night before study drug administration, supervised for at least 10 hours (h) of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 ante meridiem (am) and 10:51 am on Day 1 of each study period.
634655|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634656|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634657|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634658|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634659|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634660|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634661|NCT02446483|O2|Outcome|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634662|NCT02446483|O1|Outcome|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634663|NCT02446483|E2|Reported Event|Treatment B- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment B (rabeprazole 20 mg gastro-resistant tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634664|NCT02446483|E1|Reported Event|Treatment A- Rabeprazole 20 mg|In each period of the study, participants received one tablet of treatment A (rabeprazole 2 mg enteric coated tablet) with 240 mL of water either in sequence of treatment AB or treatment BA as per the randomization. Water was at room temperature and measured with a 250 mL cylinder. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 12 h blood sample during study drug administration of each period. The study drug administration took place between 10:00 am and 10:51 am on Day 1 of each study period. The two treatment periods were separated by a washout period of 7 days.
634665|NCT02446171|B5|Baseline|Total|Total of all reporting groups
634666|NCT02446171|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
634667|NCT02446171|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
634668|NCT02446171|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
634669|NCT02446171|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
634670|NCT02446171|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
634671|NCT02446171|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
634672|NCT02446171|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
634673|NCT02446171|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
634674|NCT02446171|O2|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634675|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634676|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634677|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634678|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634679|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634680|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634681|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634686|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634687|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634688|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634689|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634690|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634691|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634692|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634693|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634694|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634695|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634696|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634697|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634698|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634699|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634700|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634701|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634702|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634703|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634704|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634705|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634706|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634707|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634708|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634709|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634710|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634711|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634712|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634713|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634714|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634715|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634716|NCT02446171|O1|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634717|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634718|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634719|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634720|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634721|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634722|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634723|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634724|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634725|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634726|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634727|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634728|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634729|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634730|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634731|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634732|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634733|NCT02446171|O4|Outcome|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634734|NCT02446171|O3|Outcome|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634735|NCT02446171|O2|Outcome|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634736|NCT02446171|O1|Outcome|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634737|NCT02446171|E4|Reported Event|Treatment D|Participants received Naloxegol 25 mg whole tablet orally.
634738|NCT02446171|E3|Reported Event|Treatment C|Participants received Naloxegol 25 mg of 10 mL oral solution.
634739|NCT02446171|E2|Reported Event|Treatment B|Participants received Naloxegol 25 mg crushed, suspended in water, given via nasogastric tube.
634740|NCT02446171|E1|Reported Event|Treatment A|Participants received Naloxegol 25 mg oral tablet, crushed, suspended in water.
634741|NCT02446015|B3|Baseline|Total|Total of all reporting groups
640275|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
634742|NCT02446015|B2|Baseline|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
634743|NCT02446015|B1|Baseline|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
634744|NCT02446015|P2|Participant Flow|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
634745|NCT02446015|P1|Participant Flow|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days
634746|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
634747|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
634748|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
634749|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
634750|NCT02446015|O2|Outcome|Systane Ultra PRN|SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
634751|NCT02446015|O1|Outcome|Systane Ultra QID|SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days
634752|NCT02446015|E3|Reported Event|Systane Ultra PRN|All subjects treated with SYSTANE® ULTRA lubricant eye drops PRN
634753|NCT02446015|E2|Reported Event|Systane Ultra QID|All subjects treated with SYSTANE® ULTRA lubricant eye drops QID
634754|NCT02446015|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
634755|NCT02445755|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
634756|NCT02445755|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
634757|NCT02445755|O4|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
634758|NCT02445755|O3|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
634759|NCT02445755|O2|Outcome|BiliCare TcB With Infection Control Tip|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device with infection control tip.
634760|NCT02445755|O1|Outcome|BiliCare TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the BiliCare TcB device
634761|NCT02445755|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
634762|NCT02445573|B3|Baseline|Total|Total of all reporting groups
634763|NCT02445573|B2|Baseline|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634764|NCT02445573|B1|Baseline|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634765|NCT02445573|P2|Participant Flow|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634766|NCT02445573|P1|Participant Flow|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634767|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634821|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634822|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
640276|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
634768|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634769|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634770|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634771|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634772|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634773|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634774|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634775|NCT02445573|O2|Outcome|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634776|NCT02445573|O1|Outcome|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634777|NCT02445573|E2|Reported Event|Sham EA Group|sham EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
634823|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634825|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
640277|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
634778|NCT02445573|E1|Reported Event|EA Group|EA: When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 mA for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
634779|NCT02445287|B3|Baseline|Total|Total of all reporting groups
634780|NCT02445287|B2|Baseline|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
634781|NCT02445287|B1|Baseline|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph. Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
634782|NCT02445287|P2|Participant Flow|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM Cone Beam Computed Tomography (CBCT) only.
634783|NCT02445287|P1|Participant Flow|Predicate & Invest.- Cadavers 2D & 3D|Cadaveric specimens will be imaged with 2D devices CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT).
634784|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - SND|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634785|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634786|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - FDK|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634787|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634788|NCT02445287|O2|Outcome|Invest. - Cadavers & Human Subjects 3D - High Res|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634789|NCT02445287|O1|Outcome|Reference - Cadavers 3D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634923|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634790|NCT02445287|O2|Outcome|Investigational - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634791|NCT02445287|O1|Outcome|Predicate - Cadavers 2D|"The study arms are broken out by participants which include cadaveric specimens imaged on both 2D (predicate and investigational) devices and 3D (reference and investigational) devices; and human subjects on 3D investigational device only. The image data is analyzed by comparing the following: 2D images from the predicate device to 2D images of the investigational device, and 3D images from the reference device to 3D images of the investigational device. In addition, the CBCT 3D device has three separate reconstructions that are available, high resolution iterative, Feldkamp, Davis & Kress (FDK), and standard iterative (SND). Therefore the outcome measures required four separate analyses (one for 2D and three for 3D) and are listed accordingly.~All p-values were calculated (and verified) by our statistician and are correct. They were rounded to fit four digits."
634792|NCT02445287|E3|Reported Event|Investigational - Human Subjects 3D|Human subjects will be imaged with 3D investigational device CARESTREAM CBCT only.
634793|NCT02445287|E2|Reported Event|Reference & Invest. - Cadavers 3D|Cadaveric specimens will be imaged with 3D reference device Phillips MDCT and 3D investigational device CARESTREAM CBCT.
634794|NCT02445287|E1|Reported Event|Predicate & Invest.- Cadavers 2D|Cadaveric specimens will be imaged with 2D predicate device CARESTREAM DRX-1 GOS general radiograph and 2D investigational device CARESTREAM CBCT general radiograph.
634795|NCT02445196|B3|Baseline|Total|Total of all reporting groups
634796|NCT02445196|B2|Baseline|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634797|NCT02445196|B1|Baseline|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634798|NCT02445196|P2|Participant Flow|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634799|NCT02445196|P1|Participant Flow|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634800|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634801|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634802|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634824|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634803|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634804|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634805|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634806|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634807|NCT02445196|O2|Outcome|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634808|NCT02445196|O1|Outcome|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634809|NCT02445196|E2|Reported Event|Waitlist Control|"Subjects assigned to this condition are told: You have been randomly assigned to Group 2, the group that does not use the app.~Following their completion of the post-intervention assessment at 3 months, they are told how to access to the publicly available PTSD Coach app in the Apple App Store or Android Play Store, just so that they are made aware of the resources available to them.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634810|NCT02445196|E1|Reported Event|PTSD Coach|"Subjects assigned to this condition receive information about how to download the research app, PTSD Explorer. This research version of PTSD Coach functions exactly the same, however we have the ability to track individual usage of the app. The app contains contains psycho-education about PTSD and the management of symptoms of PTSD along with activities and techniques to address symptoms. Subjects are told to use the app as much or as little as they want over the next three months.~PTSD Coach: PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.~Smartphone: All participants must have a smartphone, either apple or android."
634811|NCT02444715|B3|Baseline|Total|Total of all reporting groups
634812|NCT02444715|B2|Baseline|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634813|NCT02444715|B1|Baseline|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634814|NCT02444715|P2|Participant Flow|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634815|NCT02444715|P1|Participant Flow|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634816|NCT02444715|O1|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634817|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634818|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634819|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634820|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634826|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634827|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634828|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634829|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634830|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634831|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634832|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634833|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634834|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634835|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634836|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634837|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634838|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634839|NCT02444715|O2|Outcome|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634840|NCT02444715|O1|Outcome|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634841|NCT02444715|E2|Reported Event|Interventional Care (IC)|CAPSYS: In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
634842|NCT02444715|E1|Reported Event|Standard Care (SC)|Standard care: Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
634843|NCT02444182|B3|Baseline|Total|Total of all reporting groups
634844|NCT02444182|B2|Baseline|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
634845|NCT02444182|B1|Baseline|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
634846|NCT02444182|P2|Participant Flow|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
634847|NCT02444182|P1|Participant Flow|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
634848|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
634849|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
634850|NCT02444182|O2|Outcome|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
634851|NCT02444182|O1|Outcome|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
634891|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634852|NCT02444182|E2|Reported Event|Control - No Probiotics|"Participants received a control lozenge containing no probiotics. all lozenges were sugar-free; sweetened by xylitol (0.5 g xylitol per piece)~Placebo: A half of the participants was randomly allocated to the placebo group. Lozenges with no probiotics were given twice daily for 4 weeks. Pre and Post intervention clinical exams were conducted"
634853|NCT02444182|E1|Reported Event|Probiotics|"participants received a lozenge containing mixture of probiotic bacteria BB-12 and LGG~Probiotics: A half of the participants was randomly allocated to the probiotics group. They received probiotics lozenges twice a day for 4 weeks. Pre and Post intervention clinical exams were conducted"
634854|NCT02443792|B3|Baseline|Total|Total of all reporting groups
634855|NCT02443792|B2|Baseline|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634856|NCT02443792|B1|Baseline|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634857|NCT02443792|P2|Participant Flow|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634858|NCT02443792|P1|Participant Flow|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634859|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634860|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634861|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634862|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634863|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634864|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634865|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634866|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634867|NCT02443792|O2|Outcome|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634868|NCT02443792|O1|Outcome|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634869|NCT02443792|E2|Reported Event|Open Surgical|"Open surgical circumcision under local anesthetic with suturing~Open Surgical: As above"
634870|NCT02443792|E1|Reported Event|Unicirc With Tissue Adhesive|"Unicirc under topical anesthetic w/ cyanoacrylate wound sealing~Unicirc with tissue adhesive: As above"
634871|NCT02442700|B3|Baseline|Total|Total of all reporting groups
634872|NCT02442700|B2|Baseline|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
634873|NCT02442700|B1|Baseline|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
634874|NCT02442700|P2|Participant Flow|Treatment B, A|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
634875|NCT02442700|P1|Participant Flow|Treatment A, B|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
634876|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
634877|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
634878|NCT02442700|O2|Outcome|Treatment B|Treatment visits were separated by a 2-week washout period. Treatment B = administration placebo for 12 weeks; Treatment A = administration pitavastatin for 12 weeks
634879|NCT02442700|O1|Outcome|Treatment A|Treatment visits were separated by a 2-week washout period. Treatment A = administration pitavastatin for 12 weeks; Treatment B = administration placebo for 12 weeks
634880|NCT02442700|E2|Reported Event|Treatment B|Treatment B = administration placebo for 12 weeks
634881|NCT02442700|E1|Reported Event|Treatment A|Treatment A = administration pitavastatin for 12 weeks
634882|NCT02442349|B1|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
634883|NCT02442349|P1|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
634884|NCT02442349|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
634885|NCT02442349|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
634886|NCT02442349|E1|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
634887|NCT02442310|B1|Baseline|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
634888|NCT02442310|P1|Participant Flow|Healthy Volunteers|"Subjects were randomized to receive the following four treatments in different orders, with a 7-day washout period between treatments:~Deferiprone delayed release tablets under fed conditions.~Deferiprone delayed release tablets under fasting conditions.~Deferiprone delayed release tablets administered as half-tablets, under fed conditions.~Deferiprone oral solution under fasting conditions"
634889|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
634890|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634892|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634893|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
634894|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634895|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634896|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634897|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
634898|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634899|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634900|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634901|NCT02442310|O4|Outcome|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
634902|NCT02442310|O3|Outcome|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634903|NCT02442310|O2|Outcome|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634904|NCT02442310|O1|Outcome|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634905|NCT02442310|E4|Reported Event|Oral Solution, Fasting Conditions|"A single 1200 mg dose of deferiprone oral solution, administered following a 10-hour fast~Deferiprone oral solution: Deferiprone 100 mg/mL oral solution"
634906|NCT02442310|E3|Reported Event|Delayed Release Half-tablets|"A single 1200 mg dose of deferiprone delayed release tablet formulation, following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634907|NCT02442310|E2|Reported Event|Delayed Release, Fasting Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation, administered following a 10-hour fast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634908|NCT02442310|E1|Reported Event|Delayed Release, Fed Conditions|"A single 1200 mg dose of deferiprone delayed release tablet formulation administered following a high-fat breakfast~Deferiprone delayed release tablet formulation: Deferiprone 600 mg delayed release tablet formulation"
634909|NCT02441218|B3|Baseline|Total|Total of all reporting groups
634910|NCT02441218|B2|Baseline|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634911|NCT02441218|B1|Baseline|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634912|NCT02441218|P2|Participant Flow|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634913|NCT02441218|P1|Participant Flow|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634914|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634915|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634916|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634917|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634918|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634919|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634920|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634921|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634922|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634924|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634925|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634926|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634927|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634928|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634929|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634930|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634931|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634932|NCT02441218|O2|Outcome|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634933|NCT02441218|O1|Outcome|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634934|NCT02441218|E2|Reported Event|Placebo|Placebo: Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634935|NCT02441218|E1|Reported Event|Ivabradine|Ivabradine: 2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
634936|NCT02441179|B3|Baseline|Total|Total of all reporting groups
634937|NCT02441179|B2|Baseline|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634938|NCT02441179|B1|Baseline|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634939|NCT02441179|P2|Participant Flow|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634940|NCT02441179|P1|Participant Flow|Acute Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634941|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634942|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634943|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
635356|NCT02431598|P4|Participant Flow|Saline Crossover to Dotarem Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
634944|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634945|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634946|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634947|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634948|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634949|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634950|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634951|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634952|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634953|NCT02441179|O2|Outcome|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634988|NCT02439879|B1|Baseline|Alpha Lipoic Acid Treatment|"After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid~Alpha lipoic acid: Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased >3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks."
635357|NCT02431598|P3|Participant Flow|Eovist Crossover to Saline Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
634954|NCT02441179|O1|Outcome|Intermittent Hypoxia Arm|"IH protocol: it consists of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634955|NCT02441179|E2|Reported Event|Normoxia Arm|"Sham protocol: it consisted of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. After each session, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill. All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected the patient´s posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance."
634956|NCT02441179|E1|Reported Event|Intermittent Hypoxia Arm|"IH protocol: it consisted of 15, 90-second hypoxic episodes (FiO2=0.09) interspersed with 15, 90-second normoxic intervals (FiO2=0.21) for a total time of 45 minutes. This protocol was repeated every day for 5 consecutive days and then 3 times per week for 3 weeks. After each session of IH, patients received body weight-assisted treadmill training (BWSTT) for 45 minutes.~BWSTT: Patient´s gait was trained through a weight-assisted treadmill (BWSTT). All recruited patients started BWSTT at a speed of 0.6 km/hr. The physical therapist manually corrected posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training was done immediately after the protocol of IH."
634957|NCT02441114|B1|Baseline|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
634958|NCT02441114|P1|Participant Flow|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
634959|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
634960|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
634961|NCT02441114|O1|Outcome|Inhalation of HCP0910 and HGP1011|"Single, twice and triple inhalation of HCP0910 and HGP1011 (open-label, single-arm, dose-escalation) at period 1, 2, and 3, respectively.~The periods were separated with a washout period of 14 days."
634962|NCT02441114|E1|Reported Event|HCP0910 and HGP1011|"Single Inhalation of HCP0910 and HGP1011 (Open-label, Single-arm, Single dosing, Dose-escalation)~HCP0910 and HGP1011: Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))"
634963|NCT02440659|B3|Baseline|Total|Total of all reporting groups
634964|NCT02440659|B2|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
634965|NCT02440659|B1|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
634966|NCT02440659|P2|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
634967|NCT02440659|P1|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
634968|NCT02440659|O2|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
634969|NCT02440659|O1|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
634970|NCT02440659|E2|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
634971|NCT02440659|E1|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
634972|NCT02440633|B1|Baseline|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
634973|NCT02440633|P1|Participant Flow|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
634974|NCT02440633|O1|Outcome|Plasma|
634975|NCT02440633|O2|Outcome|Whole Blood|
634976|NCT02440633|O1|Outcome|Plasma|
634977|NCT02440633|O3|Outcome|Total|
634978|NCT02440633|O2|Outcome|Urine|
634979|NCT02440633|O1|Outcome|Feces|
634980|NCT02440633|E1|Reported Event|14C-OPS-2071|"Suspension containing 50 mg of 14C-OPS-2071~14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly."
634981|NCT02440308|B1|Baseline|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
634982|NCT02440308|P1|Participant Flow|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
634983|NCT02440308|O1|Outcome|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
634984|NCT02440308|O1|Outcome|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
634985|NCT02440308|E1|Reported Event|68Ga-DOTA-Bombesin PET/MRI|Patients receive 68Ga-DOTA-Bombesin IV and then undergo PET/MRI approximately 1 hour later.
634986|NCT02439879|B3|Baseline|Total|Total of all reporting groups
634987|NCT02439879|B2|Baseline|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
634989|NCT02439879|P2|Participant Flow|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
634990|NCT02439879|P1|Participant Flow|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
634991|NCT02439879|O2|Outcome|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
634992|NCT02439879|O1|Outcome|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
634993|NCT02439879|E2|Reported Event|Alpha Lipoic Acid Withdrawal|After a decrease in the total symptoms Score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks no treatment
634994|NCT02439879|E1|Reported Event|Alpha Lipoic Acid Treatment|After a decrease in the total symptoms score >3 points with 600 mg orally tid of alpha lipoic acid for 4 weeks patients were randomized to recieve for 16 weeks 600 mg orally once a day of alpha lipoic acid
634995|NCT02439138|B1|Baseline|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
634996|NCT02439138|P1|Participant Flow|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
634997|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
634998|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
634999|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
635000|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
635001|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
635002|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
635003|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
635004|NCT02439138|O1|Outcome|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
635005|NCT02439138|E1|Reported Event|GS-1101|"After the screening procedures confirms eligibility to participate in the research study. Treatment will be administered on an outpatient basis.~-- Idelalisib (GS-11-01) orally, predetermined dose twice daily per cycle for up to 6 cycles. After this initial 6 month period, for Cycles 7 and beyond, Idelalisib will be administered once a day until disease progression.~GS-1101"
635006|NCT02438540|B3|Baseline|Total|Total of all reporting groups
635007|NCT02438540|B2|Baseline|Metformin & Placebo|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and placebo ( for acupuncture treatment including electro body acupuncture and Auricular acupuncture), needling not in right acupoints (for those points that were located in the abdomen, needles were inserted 0.3 cm laterally from the real location and the needling was maximally superficial. Those points that were located on other parts of the body, needles were inserted 0.5 cm up and 0.5 cm laterally from the real location and needling was superficial as well. Electric lines were connected with some of the needles same way they were connected in another case group. EA machine was switched off during 30 minutes of therapeutic time. Ear acupuncture was used on the same location as in the case group however we just used sticky layers without seeds), for 30 minutes, 10 times, every other day, for 3 weeks.~metformin Placebo (for acupuncture including electro"
635088|NCT02437305|E2|Reported Event|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
635008|NCT02438540|B1|Baseline|Metformin & Acupuncture|"Metformin 500 mg, to control their diabetes during the period of this study as previously (with different therapeutic dosage) and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635009|NCT02438540|P2|Participant Flow|Metformin & Placebo|Metformin 500 mg (one/two/three times per day) to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and electro acupuncture (EA) machine was switched off during 30 minutes of therapeutic time. And ear acupuncture was just used sticky layers without seeds. All placebo treatments used for 30 minutes, 10 times, every other day, for 3 weeks.
635010|NCT02438540|P1|Participant Flow|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635011|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635012|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635013|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635014|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635015|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635016|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635017|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635018|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635019|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635020|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635021|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635022|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635023|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635202|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635024|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635025|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635026|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635027|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635028|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635029|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635030|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635031|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635032|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635033|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635034|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635035|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635036|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635037|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635038|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635039|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635203|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635040|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635041|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635042|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635043|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo EA and auricular acupuncture"
635044|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635045|NCT02438540|O2|Outcome|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635046|NCT02438540|O1|Outcome|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635047|NCT02438540|E2|Reported Event|Metformin & Placebo|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and placebo acupuncture treatment, needling not in right acupoints and EA machine was switched off during 30 minutes of therapeutic time. For ear acupuncture was just used sticky layers without seeds. All placebo treatment used for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~Placebo acupuncture including placebo EA and auricular acupuncture"
635048|NCT02438540|E1|Reported Event|Metformin & Acupuncture|"Metformin 500 mg (one/two/three times per day), to control their diabetes during the period of this study as previously, and acupuncture treatment including electro body acupuncture and Auricular acupuncture for 30 minutes, 10 times, every other day, for 3 weeks.~metformin~acupuncture: Electro body acupuncture and auricular acupuncture"
635049|NCT02438137|B3|Baseline|Total|Total of all reporting groups
635050|NCT02438137|B2|Baseline|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
635051|NCT02438137|B1|Baseline|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
635052|NCT02438137|P2|Participant Flow|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
635062|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
635111|NCT02436577|P5|Participant Flow|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635053|NCT02438137|P1|Participant Flow|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
635054|NCT02438137|O2|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Subjects randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Subjects were instructed to take the placebo with food, in the morning and at dinnertime. If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
635055|NCT02438137|O1|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day, though slower dose escalations were possible to increase tolerability, if necessary. Subjects randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance was reconciled at follow-up visits, and recorded in accountability logs. Subjects were instructed to take medication with food, (morning and at dinnertime). If subjects missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
635056|NCT02438137|O2|Outcome|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo will be instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
635057|NCT02438137|O1|Outcome|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
635058|NCT02438137|E2|Reported Event|Placebo|"The placebo is an inert product that looks like a pill and is identical to dimethyl fumarate capsules, but it contains no medicine. Participants randomized to placebo were instructed to take placebo twice a day with breakfast and dinner for a period of 4 months.~Placebo: Placebo capsules were dispensed during routine study appointments. Placebo were dispensed in 1 month supply, so that compliance could be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants were instructed to take the placebo with food, in the morning and at dinnertime. If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously missed a dose."
635059|NCT02438137|E1|Reported Event|Dimethyl Fumarate (Tecfidera®) Capsules|"The starting dose for dimethyl fumarate was 120 mg twice a day orally. After 7 days, the dose was increased to the maintenance dose of 240 mg twice a day. Slower dose escalations were allowed to increase tolerability, if necessary. Participants randomized to dimethyl fumarate were instructed to take this medication twice a day with breakfast and dinner for a period of 4 months.~Dimethyl fumarate: Dimethyl fumarate capsules were dispensed at routine study appointments. 120 mg tablets were dispensed to facilitate dose titrations. Drug was dispensed in 1 month supply, so that compliance could be reconciled at follow-up visits, and recorded in accountability logs. Participants were instructed to take medication with food, (morning and at dinnertime). If participants missed a dose, they were instructed to resume their normal dose at the next scheduled time, and not to take an extra dose at their next dosing interval if they previously miss a dose."
635060|NCT02437903|B1|Baseline|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
635061|NCT02437903|P1|Participant Flow|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
635351|NCT02431741|O1|Outcome|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
640278|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
635063|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
635064|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
635065|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
635066|NCT02437903|O1|Outcome|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12"
635067|NCT02437903|E1|Reported Event|JUVÉDERM VOLUMA™ XC|"Subjects will be injected with JUVÉDERM VOLUMA™ XC to their right and left facial temporal regions at the baseline visit.~JUVÉDERM VOLUMA™ XC: Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, and month 6."
635068|NCT02437409|B1|Baseline|All Patients|Treated with pREset Thrombectomy Retriever
635069|NCT02437409|P1|Participant Flow|All Patients|Treated with pREset Thrombectomy Retriever
635070|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
635071|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
635072|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
635073|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
635074|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
635075|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
635076|NCT02437409|O1|Outcome|Occluded Vessels|100 patients harboured 109 vessel occlusions
635077|NCT02437409|O1|Outcome|All Patients|Treated with pREset Thrombectomy Retriever
635078|NCT02437409|E1|Reported Event|All Patients|Treated with pREset Thrombectomy Retriever
635079|NCT02437305|B3|Baseline|Total|Total of all reporting groups
635080|NCT02437305|B2|Baseline|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
635081|NCT02437305|B1|Baseline|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
635082|NCT02437305|P2|Participant Flow|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
635083|NCT02437305|P1|Participant Flow|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
635084|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
635085|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
635086|NCT02437305|O2|Outcome|ABCDEs of Melanoma|"A conventional melanoma educational intervention using the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation.~ABCDEs of Melanoma: Conventional melanoma educational intervention."
635087|NCT02437305|O1|Outcome|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
640279|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
635089|NCT02437305|E1|Reported Event|ABCDEs of Melanoma Skin Cancer|"A modified melanoma educational intervention that uses the ABCDEs of Melanoma pamphlet from the Skin Cancer Foundation but also incorporates the nomenclature melanoma skin cancer; indicates that melanoma is relevant for everyone regardless of race and ethnicity; includes images of melanoma on ethnic skin; informs people of the likelihood of melanoma developing in acral, subungual and mucosal surfaces; and provides guidance on self-skin examinations.~ABCDEs of Melanoma Skin Cancer: Modified melanoma educational intervention that is targeted towards people of color."
635090|NCT02436811|B4|Baseline|Total|Total of all reporting groups
635091|NCT02436811|B3|Baseline|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
635092|NCT02436811|B2|Baseline|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
635093|NCT02436811|B1|Baseline|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
635094|NCT02436811|P3|Participant Flow|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
635095|NCT02436811|P2|Participant Flow|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
635096|NCT02436811|P1|Participant Flow|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
635097|NCT02436811|O3|Outcome|Control|women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
635098|NCT02436811|O2|Outcome|Written Form Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
635099|NCT02436811|O1|Outcome|Standardized Oral Instruction|women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
635100|NCT02436811|E3|Reported Event|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
635101|NCT02436811|E2|Reported Event|Written Form Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
635102|NCT02436811|E1|Reported Event|Standardized Oral Instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
635103|NCT02436577|B7|Baseline|Total|Total of all reporting groups
635104|NCT02436577|B6|Baseline|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635105|NCT02436577|B5|Baseline|BAC Sequence|Subjects were administered a single dose of Treatment B, A and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635106|NCT02436577|B4|Baseline|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635107|NCT02436577|B3|Baseline|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635108|NCT02436577|B2|Baseline|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635109|NCT02436577|B1|Baseline|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635110|NCT02436577|P6|Participant Flow|CBA Sequence|Subjects were administered a single dose of Treatment C, B and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635352|NCT02431741|E1|Reported Event|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
635112|NCT02436577|P4|Participant Flow|ACB Sequence|Subjects were administered a single dose of Treatment A, C and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635113|NCT02436577|P3|Participant Flow|CAB Sequence|Subjects were administered a single dose of Treatment C, A and B as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635114|NCT02436577|P2|Participant Flow|BCA Sequence|Subjects were administered a single dose of Treatment B, C and A as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635115|NCT02436577|P1|Participant Flow|ABC Sequence|Subjects were administered a single dose of Treatment A, B and C as first, second and third interventions (3 days each) respectively where each intervention is separated by the washout period of minimum 7 days.
635116|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635117|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635118|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635119|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635120|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635121|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635122|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635123|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635124|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635125|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635126|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635127|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635128|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635129|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635130|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635131|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635132|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635133|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635134|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635135|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635136|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635137|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635138|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635139|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635140|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635141|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635142|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635143|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635144|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635353|NCT02431598|B1|Baseline|Eovistvs vs. Dotarem vs. Saline|
635145|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635146|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635147|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635148|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635149|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635150|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635151|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635152|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635153|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635154|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635155|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635156|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635157|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635158|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635159|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635160|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635161|NCT02436577|O3|Outcome|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635162|NCT02436577|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635163|NCT02436577|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635164|NCT02436577|E3|Reported Event|Treatment C|Participants received Ticagrelor IR tablets administered orally with 150 mL of water.
635165|NCT02436577|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with saliva.
635166|NCT02436577|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed with dry hands on the tongue for disintegration and was swallowed subsequently with 150 mL non-carbonated water at room temperature.
635167|NCT02436330|B3|Baseline|Total|Total of all reporting groups
635168|NCT02436330|B2|Baseline|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
635169|NCT02436330|B1|Baseline|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
635170|NCT02436330|P2|Participant Flow|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period.~n = 24 (29%) enrolled within 6 cohorts during the study period from April 2011 to September 2013"
635171|NCT02436330|P1|Participant Flow|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period.~n = 60 (71%) enrolled within 6 cohorts over the study period from April 2011 to September 2013."
635172|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
635173|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
635174|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
635175|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
635176|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Intervention group subjects (exergaming combined with didactic nutrition teaching) with continued participation at 6 months completed this questionnaire regarding attitudes/perceptions towards participation.
635177|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635178|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635179|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635180|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635181|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635182|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635183|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635184|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635185|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635186|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635187|NCT02436330|O2|Outcome|Didactic Health Teaching|Subjects only receiving classroom structured nutrition/health education.
635188|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects attending exergaming/physical activity along with classroom structured nutrition/health education.
635189|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
635190|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
635191|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635192|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635193|NCT02436330|O2|Outcome|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
635194|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
635195|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635196|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635197|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635198|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635199|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635200|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635201|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635204|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635205|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635206|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635207|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Subjects remaining in the study at 1 year post start of participation in the exergaming combined with didactic health teaching sessions, 14 sessions over 6 month period, followed by 6 months of non-participation in group activity.
635208|NCT02436330|O2|Outcome|Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.
635209|NCT02436330|O1|Outcome|Exergaming and Didactic Health Teaching|Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.
635210|NCT02436330|E2|Reported Event|Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting only of didactic teaching.~Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour didactic health teaching sessions for the remainder of the 6 month period."
635211|NCT02436330|E1|Reported Event|Exergaming and Didactic Health Teaching|"Participation of child and parent/guardian in 6 months of weight management programming consisting of exergaming combined with didactic teaching.~Exergaming and Didactic health teaching: 6 months of weight management programming consisting of 10 weekly 2- hour sessions:1 hour of exergaming and 1 hour of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1-hour maintenance didactic teaching for the remainder of the 6 month period."
635212|NCT02436031|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 1 participant was excluded due to insufficient sleep time.
635213|NCT02436031|P2|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
635214|NCT02436031|P1|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
635215|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
635216|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
635217|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
635218|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
635219|NCT02436031|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
635220|NCT02436031|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
635221|NCT02436031|E2|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
635222|NCT02436031|E1|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
635223|NCT02435966|B4|Baseline|Total|Total of all reporting groups
635224|NCT02435966|B3|Baseline|Untreated Control|Natural history of the condition
635225|NCT02435966|B2|Baseline|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635226|NCT02435966|B1|Baseline|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635227|NCT02435966|P3|Participant Flow|Untreated Control|Natural history of the condition
635228|NCT02435966|P2|Participant Flow|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635229|NCT02435966|P1|Participant Flow|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635230|NCT02435966|O3|Outcome|Untreated Control|Natural history of the condition
635231|NCT02435966|O2|Outcome|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635232|NCT02435966|O1|Outcome|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635233|NCT02435966|E3|Reported Event|Untreated Control|Natural history of the condition
635234|NCT02435966|E2|Reported Event|Manual Therapy + Sham Dry Needling|"Manual therapy + Sham Dry needling: after a 7 days interval~Sham Dry needling: Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635235|NCT02435966|E1|Reported Event|Manual Therapy + Dry Needling|"Manual therapy + Dry needling: 2 sessions, after a 7 days interval~Dry needling: Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)~Manual therapy: Standard manual therapy in the upper trapezius or the levator scapulae"
635236|NCT02435836|B1|Baseline|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635237|NCT02435836|P1|Participant Flow|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635238|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635239|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635240|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635241|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635242|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635243|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635244|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635245|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635246|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635247|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635248|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635249|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635250|NCT02435836|O1|Outcome|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635251|NCT02435836|E1|Reported Event|Aripiprazole|All participants began open-label treatment with 30 mg aripiprazole on the first day of participation in the current trial. Once a participant stabilized at the 30 mg per day dose, the study physician could adjust the dose within the range of 10 to 30 mg per day as needed (throughout this long-term trial), to manage adverse events.
635252|NCT02434939|B3|Baseline|Total|Total of all reporting groups
635253|NCT02434939|B2|Baseline|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635409|NCT02431299|O1|Outcome|IMR Clinicians|Clinicians providing IMR to the IMR consumers.
635254|NCT02434939|B1|Baseline|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635255|NCT02434939|P2|Participant Flow|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635256|NCT02434939|P1|Participant Flow|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635257|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635258|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635259|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes . Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635260|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635261|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635262|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635263|NCT02434939|O2|Outcome|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635264|NCT02434939|O1|Outcome|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635265|NCT02434939|E2|Reported Event|Morphine|"Morphine 0.1mg/kg given as an IV infusion via a syringe pump over 10 minutes. Maximum of 2 doses to be given during the study period that will last 2 hours.~Morphine: Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635266|NCT02434939|E1|Reported Event|Low Dose Ketamine|"Low dose ketamine 1mg/kg given as an IV infusion via syringe pump over 10 minutes. Maximum of 2 doses to be given during study period that will last 2 hours.~Low dose ketamine: Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min."
635267|NCT02434523|B3|Baseline|Total|Total of all reporting groups
635268|NCT02434523|B2|Baseline|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635269|NCT02434523|B1|Baseline|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635270|NCT02434523|P2|Participant Flow|Placebo|Subjects in this arm will receive pills composed only of Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635271|NCT02434523|P1|Participant Flow|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635354|NCT02431598|P6|Participant Flow|Saline Crossover to Eovist Crossover to Dotarem|Subjects received the agents in this particular order during their MRI.
635272|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635273|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635274|NCT02434523|O2|Outcome|Placebo|"Subjects in this arm will receive pills composed only of Avicel (cellulose filler)~Placebo: Placebo pill"
635275|NCT02434523|O1|Outcome|Amitriptyline|"Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler)~Amitriptyline"
635276|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635277|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635278|NCT02434523|O2|Outcome|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635279|NCT02434523|O1|Outcome|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635280|NCT02434523|E2|Reported Event|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635281|NCT02434523|E1|Reported Event|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
635282|NCT02434146|B1|Baseline|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635283|NCT02434146|P1|Participant Flow|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635284|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635285|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635286|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635287|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635288|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635289|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635290|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
640280|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
635291|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635292|NCT02434146|O1|Outcome|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635293|NCT02434146|E1|Reported Event|Supportive Care (Topical Phenylephrine Solution)|"Patients undergoing a cyclophosphamide and total body irradiation regimen receive topical phenylephrine solution via spray to the oral mucosa 15-20 minutes prior to each cyclophosphamide infusion, 25-30 minutes after the beginning of each cyclophosphamide infusion, and 15-20 minutes prior to each radiation treatment.~Topical Phenylephrine Solution: Given topically via spray"
635294|NCT02433366|B3|Baseline|Total|Total of all reporting groups
635295|NCT02433366|B2|Baseline|Patients|AF patients on treatment with Pradaxa®.
635296|NCT02433366|B1|Baseline|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
635297|NCT02433366|P2|Participant Flow|Patients|AF patients on treatment with Pradaxa®.
635298|NCT02433366|P1|Participant Flow|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
635299|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
635300|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
635301|NCT02433366|O2|Outcome|Patients|AF patients on treatment with Pradaxa®.
635302|NCT02433366|O1|Outcome|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
635303|NCT02433366|E2|Reported Event|Patients|AF patients on treatment with Pradaxa®.
635304|NCT02433366|E1|Reported Event|Physicians|Current prescribers of Pradaxa® for stroke prevention in patients with atrial fibrillation (AF).
635305|NCT02432040|B3|Baseline|Total|Total of all reporting groups
635306|NCT02432040|B2|Baseline|Placebo|Placebo tablets But patients are still asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635307|NCT02432040|B1|Baseline|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635308|NCT02432040|P2|Participant Flow|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635309|NCT02432040|P1|Participant Flow|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635310|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635311|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635312|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635313|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635314|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635315|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635316|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635317|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635318|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635319|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635320|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635321|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635322|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635323|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635324|NCT02432040|O2|Outcome|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635355|NCT02431598|P5|Participant Flow|Dotarem Crossover to Saline Crossover to Eovist|Subjects received the agents in this particular order during their MRI.
635325|NCT02432040|O1|Outcome|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635326|NCT02432040|E2|Reported Event|Placebo|Placebo tablets Patients are asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most
635327|NCT02432040|E1|Reported Event|Atorvastatin|"Atorvastatin 40 mg once a day at night Patients asked to apply Betamethasone valerate 0.1% ointment twice a day, 3 weeks on, 1 week off, at the most~Atorvastatin: Atorvastatin is an HMG-CoA reductase inhibitor used to treat dyslipidemia"
635328|NCT02431754|B3|Baseline|Total|Total of all reporting groups
635329|NCT02431754|B2|Baseline|Placebo/Tadalafil|"Placebo administered once daily orally for 8 weeks in one of two treatment periods.~5 mg tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635330|NCT02431754|B1|Baseline|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered QD orally for 8 weeks in one of two treatment periods.~Placebo administered once daily orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635331|NCT02431754|P2|Participant Flow|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods.~5 mg tadalafil administered orally QD for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635332|NCT02431754|P1|Participant Flow|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~Placebo administered once daily orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635333|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635334|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635335|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635336|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635337|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635338|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635339|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635340|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635341|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635342|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635343|NCT02431754|O2|Outcome|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635344|NCT02431754|O1|Outcome|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635345|NCT02431754|O2|Outcome|Placebo/Tadalafil|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635346|NCT02431754|O1|Outcome|Tadalafil/Placebo|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635347|NCT02431754|E2|Reported Event|Placebo|"Placebo administered orally QD for 8 weeks in one of two treatment periods. 0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635348|NCT02431754|E1|Reported Event|Tadalafil|"5 milligrams (mg) tadalafil administered once daily (QD) orally for 8 weeks in one of two treatment periods.~0.2 mg tamulosin once daily or 4 mg silodosin twice daily.~Participants will remain on stable dose of alpha1 blocker through both treatment periods."
635349|NCT02431741|B1|Baseline|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
635350|NCT02431741|P1|Participant Flow|Mepilex Transfer Ag|"Non controlled investigation~Mepilex Transfer Ag"
635358|NCT02431598|P2|Participant Flow|Dotarem Crossover to Eovist Crossover to Saline|Subjects received the agents in this particular order during their MRI.
635359|NCT02431598|P1|Participant Flow|Eovist Crossover to Dotarem Crossover to Saline|Subjects received the agents in this particular order during their MRI.
635360|NCT02431598|O4|Outcome|Last Dynamic Phase|Imaging obtained during late dynamic phase
635361|NCT02431598|O3|Outcome|Portal Venous Phase|Imaging obtained during portal venous phase
635362|NCT02431598|O2|Outcome|Arterial Phase|Imaging obtained during arterial phase
635363|NCT02431598|O1|Outcome|Pre-Contrast Phase|Prior to contrast injection
635364|NCT02431598|O3|Outcome|Saline|Injection of normal saline
635365|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
635366|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
635367|NCT02431598|O3|Outcome|Saline|Injection of normal saline
635368|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
635369|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
635370|NCT02431598|O3|Outcome|Saline|Injection of normal saline
635371|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
635372|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
635373|NCT02431598|O3|Outcome|Dotarem (Gadoterate Dimeglumine)|Injection of gadoterate dimeglumine
635374|NCT02431598|O2|Outcome|Saline|Injection of normal saline
635375|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|Injection of gadoxetate disodium
635376|NCT02431598|O3|Outcome|Saline|
635377|NCT02431598|O2|Outcome|Dotarem (Gadoterate Dimeglumine)|
635378|NCT02431598|O1|Outcome|Eovist (Gadoxetate Disodium)|
635379|NCT02431598|E3|Reported Event|Saline|
635380|NCT02431598|E2|Reported Event|Dotarem (Gadoterate Dimeglumine)|
635381|NCT02431598|E1|Reported Event|Eovist (Gadoxetate Disodium)|
635382|NCT02431455|B3|Baseline|Total|Total of all reporting groups
635383|NCT02431455|B2|Baseline|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
635384|NCT02431455|B1|Baseline|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
635385|NCT02431455|P2|Participant Flow|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
635386|NCT02431455|P1|Participant Flow|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
635387|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
635388|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
635389|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
635390|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
635391|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
635392|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
635393|NCT02431455|O2|Outcome|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
635394|NCT02431455|O1|Outcome|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
635395|NCT02431455|E2|Reported Event|No Incentive Spirometry|"No incentive spirometer provided~No incentive spirometer: No incentive spirometer is provided to the patient, this is the study arm."
635396|NCT02431455|E1|Reported Event|Incentive Spirometry|"Incentive spirometry 10 times per hour while awake~Incentive spirometer: Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm."
635397|NCT02431299|B3|Baseline|Total|Total of all reporting groups
635398|NCT02431299|B2|Baseline|IMR Clinicians|Clinicians who provided the IMR intervention to the IMR Consumers
635399|NCT02431299|B1|Baseline|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635400|NCT02431299|P2|Participant Flow|IMR Clinicians|The clinicians who provided IMR intervention to the IMR Consumers
635401|NCT02431299|P1|Participant Flow|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635402|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635403|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635404|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635405|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635406|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635407|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635408|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635410|NCT02431299|O1|Outcome|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635411|NCT02431299|E2|Reported Event|IMR Clinicians|Clinician participants who are providing Illness Management and Recovery (IMR) intervention.
635412|NCT02431299|E1|Reported Event|IMR Consumers|Consumer participants who are engaging in Illness Management and Recovery (IMR) intervention.
635413|NCT02430870|B9|Baseline|Total|Total of all reporting groups
635414|NCT02430870|B8|Baseline|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635415|NCT02430870|B7|Baseline|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635416|NCT02430870|B6|Baseline|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635417|NCT02430870|B5|Baseline|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635418|NCT02430870|B4|Baseline|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635419|NCT02430870|B3|Baseline|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635420|NCT02430870|B2|Baseline|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635421|NCT02430870|B1|Baseline|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635422|NCT02430870|P8|Participant Flow|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635423|NCT02430870|P7|Participant Flow|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635424|NCT02430870|P6|Participant Flow|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635425|NCT02430870|P5|Participant Flow|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635426|NCT02430870|P4|Participant Flow|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635427|NCT02430870|P3|Participant Flow|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635428|NCT02430870|P2|Participant Flow|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635429|NCT02430870|P1|Participant Flow|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635430|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635431|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635432|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635433|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635434|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
640281|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
635435|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635436|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635437|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635438|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635439|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635440|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635441|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635442|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635443|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635444|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635445|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635446|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635447|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635448|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635449|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635450|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635451|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635452|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635453|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635454|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635455|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635456|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635457|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635458|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635459|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635460|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635461|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635462|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635463|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635464|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635465|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635466|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635467|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635468|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635469|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635470|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635471|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635472|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635473|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635474|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635475|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635476|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635477|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635478|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635479|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635480|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635553|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
635481|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635482|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635483|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635484|NCT02430870|O5|Outcome|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635485|NCT02430870|O4|Outcome|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635486|NCT02430870|O3|Outcome|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635487|NCT02430870|O2|Outcome|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635488|NCT02430870|O1|Outcome|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635489|NCT02430870|O3|Outcome|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635490|NCT02430870|O2|Outcome|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635491|NCT02430870|O1|Outcome|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635492|NCT02430870|E8|Reported Event|Part 2: Placebo Cohort 1-4|Healthy participants of Japanese descent in study Part 2, received TAK-648 placebo-matching solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635493|NCT02430870|E7|Reported Event|Part 2 Cohort 4: TAK-648 0.80 mg|Healthy participants of Japanese descent in study Part 2, Cohort 4 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635494|NCT02430870|E6|Reported Event|Part 2 Cohort 3: TAK-648 0.35 mg|Healthy participants of Japanese descent in study Part 2, Cohort 3 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635495|NCT02430870|E5|Reported Event|Part 2 Cohort 2: TAK-648 0.15 mg|Healthy participants of Japanese descent in study Part 2, Cohort 2 received TAK-648 0.15 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635496|NCT02430870|E4|Reported Event|Part 2 Cohort 1: TAK-648 0.05 mg|Healthy participants of Japanese descent in study Part 2, Cohort 1 received TAK-648 0.05 mg, solution , orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by multiple QD doses starting on Day 4 and continuing through Day 10 (7 days).
635497|NCT02430870|E3|Reported Event|Part 1: Placebo Cohort 1-2|Participants with T2DM in study Part 1 received placebo-matching TAK-648, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635498|NCT02430870|E2|Reported Event|Part 1 Cohort 2: TAK-648 0.80 mg|Participants with T2DM in study Part 1, Cohort 2 received TAK-648 0.80 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635499|NCT02430870|E1|Reported Event|Part 1 Cohort 1: TAK-648 0.35 mg|Participants with T2DM in study Part 1, Cohort 1 received TAK-648 0.35 mg, solution, orally, single dose on Day 1, no drug administration on Days 2 to 3, followed by once daily (QD) doses starting on Day 4 and continuing through Day 17 (14 days).
635500|NCT02430532|B3|Baseline|Total|Total of all reporting groups
635501|NCT02430532|B2|Baseline|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635502|NCT02430532|B1|Baseline|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635503|NCT02430532|P2|Participant Flow|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635504|NCT02430532|P1|Participant Flow|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635505|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635506|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635507|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635508|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635509|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635510|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635511|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635512|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635513|NCT02430532|O2|Outcome|Tecfidera 240 mg BID|BG00012 120 mg orally twice daily (BID) for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635514|NCT02430532|O1|Outcome|Placebo|BG00012 120 mg capsule orally once a day (QD) supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635515|NCT02430532|E2|Reported Event|Tecfidera 240 mg BID|BG00012 120 mg orally BID for 1 week, followed by BG00012 240 mg orally BID beginning on Day 8 for up to 108 weeks.
635516|NCT02430532|E1|Reported Event|Placebo|BG00012 120 mg capsule orally QD supplemented with matching placebo capsules for the first 4 weeks of treatment. Matched placebo capsules only thereafter for up to 108 weeks.
635517|NCT02430389|B3|Baseline|Total|Total of all reporting groups
635518|NCT02430389|B2|Baseline|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
635519|NCT02430389|B1|Baseline|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
635520|NCT02430389|P2|Participant Flow|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
635521|NCT02430389|P1|Participant Flow|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
635522|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Normal Saline: Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
635523|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered"
635524|NCT02430389|O2|Outcome|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
635525|NCT02430389|O1|Outcome|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
635526|NCT02430389|E2|Reported Event|Normal Saline|"Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Placebo"
635527|NCT02430389|E1|Reported Event|Remifentanil|"Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).~Remifentanil: To determine if addition of remifentanil as an adjuvant with propofol will attenuate hemodynamic response to head pinning for the next ten minutes during and after pinning."
635528|NCT02430090|B4|Baseline|Total|Total of all reporting groups
635529|NCT02430090|B3|Baseline|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635530|NCT02430090|B2|Baseline|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635531|NCT02430090|B1|Baseline|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635532|NCT02430090|P3|Participant Flow|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635533|NCT02430090|P2|Participant Flow|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635534|NCT02430090|P1|Participant Flow|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635535|NCT02430090|O3|Outcome|Levobupivacaine + Sufentanil|2 ml of 0.5% levobupivacaine was added to 1 ml of 1,5 µcg sufentanil in group III by intrathecal administration
635536|NCT02430090|O2|Outcome|Levobupivacaine + Fentanyl|2 ml of 0.5% levobupivacaine was added to 1 ml of 15 µcg of fentanyl in group II by intrathecal administration
635537|NCT02430090|O1|Outcome|Levobupivacaine|2 ml of 0.5% levobupivacaine was added to 1 ml of saline in group I by intrathecal administration
635538|NCT02430090|E3|Reported Event|Levobupivacaine + Sufentanil|"Sufentanil is a synthetic opioid analgesic. Sufentanil exerts its principal pharmacologic effects on the central nervous system. Its primary actions of therapeutic value are analgesia and sedation.~Maintenance: Additional doses of 0.5-10 mcg/kg may be given if needed. Max (total dose): 30 mcg/kg. Post-op pain Initial: 30-60 mcg. Additional doses of up to 25 mcg may be given at intervals of ≥1 hr if needed. Epidural Pain relief during labour and delivery W/ bupivacaine: 10-15 mcg w/ or w/o epinephrine. May repeat dose twice at intervals of ≥1 hr till delivery. Max (total dose): 30 mcg.~Read more: http://www.ndrugs.com/?s=sufentanil#ixzz3XvqVyLzx~Sufentanil: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635539|NCT02430090|E2|Reported Event|Levobupivacaine + Fentanyl|"Fentanyl - Used for: Producing anesthesia for surgery and treating pain before, during, and after surgery.Fentanyl is a narcotic (opioid) analgesic. It works in the brain and nervous system to cause anesthesia and decrease pain.~Indications:~Adult: PO Breakthrough cancer pain As a loz: Initially, 200 mcg over 15 minutes for an episode of breakthrough pain; may repeat once after 15 minutes if needed. Not more than 4 unit doses/day. IV Adjunct to general anesth Patients w/ spontaneous resp: Initial: 50-200 mcg, w/ supplements of 50 mcg. Patients w/ assisted ventilation: Initial: 300-3,500 mcg (up to 50 mcg/kg), w/ supplements of 100-200 mcg depending on response.~Read more: http://www.ndrugs.com/?s=fentanyl#ixzz3XvpAcULL~Fentanyl: this used in intratechal area and for spinal anesthesia in ceserean section~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635540|NCT02430090|E1|Reported Event|Levobupivacaine|"Levobupivacaine, a local anesthetic agent, is indicated for the production of local or regional anesthesia or analgesia for surgery, for oral surgery procedures, for diagnostic and therapeutic procedures, and for obstetrical procedures.~Injection Surgical anaesthesia~Adult: Epidural block: 50-100 mg (10-20 ml) of a 0.5% solution or 75-150 mg (10-20 ml) of a 0.75% solution. Caesarean section: 75-150 mg (15-30 ml) of a 0.5% solution. Spinal block: 15 mg (3 ml) of a 0.5% solution. Max: 150 mg/dose; 400 mg/day. Injection Peripheral nerve block~Read more: http://www.ndrugs.com/?s=levobupivacaine#ixzz3Xvp0iS5T~Levobupivacaine: this used in intratechal area and for spinal anesthesia in ceserean section"
635541|NCT02429258|B3|Baseline|Total|Total of all reporting groups
635542|NCT02429258|B2|Baseline|Placebo|Placebo + Metformin or Insulin
635543|NCT02429258|B1|Baseline|Dapagliflozin|Dapagliflozin + Metformin or Insulin
635544|NCT02429258|P2|Participant Flow|Placebo|Placebo + Metformin or Insulin
635545|NCT02429258|P1|Participant Flow|Dapagliflozin|Dapagliflozin + Metformin or Insulin
635546|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
635547|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
635548|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
635549|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
635550|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
635551|NCT02429258|O1|Outcome|Dapagliflozin|Dapagliflozin + Metformin or Insulin
635552|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
635554|NCT02429258|O2|Outcome|Placebo|Placebo + Metformin or Insulin
635570|NCT02428478|B1|Baseline|All Analyzed Participants|All participants who were randomized, completed both study nights, and were included in the analysis. 4 participants were excluded: 3 due to intermittent electromyographic amplifier malfunction; and 1 did not sleep on both study nights.
635571|NCT02428478|P2|Participant Flow|Placebo First, Desipramine Second|Placebo-matching desipramine administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then desipramine administered 2 hours before normal sleep time on second study night.
635572|NCT02428478|P1|Participant Flow|Desipramine First, Placebo Second|Desipramine 200 mg administered 2 hours before normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching desipramine administered 2 hours before normal sleep time on second study night.
635573|NCT02428478|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
635574|NCT02428478|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
635575|NCT02428478|O2|Outcome|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
635576|NCT02428478|O1|Outcome|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
635577|NCT02428478|E2|Reported Event|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time on the first study night or second study night.
635578|NCT02428478|E1|Reported Event|Desipramine|Desipramine 200 mg administered 2 hours before normal sleep time on the first study night or second study night.
635579|NCT02428413|B3|Baseline|Total|Total of all reporting groups
635580|NCT02428413|B2|Baseline|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
635581|NCT02428413|B1|Baseline|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
635582|NCT02428413|P2|Participant Flow|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
635583|NCT02428413|P1|Participant Flow|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
635584|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
635585|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
635586|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
635587|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
635588|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
635589|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
635590|NCT02428413|O2|Outcome|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
635591|NCT02428413|O1|Outcome|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
635592|NCT02428413|E2|Reported Event|ISO-Gard Mask|"Face mask to scavenge waste anesthetic gases from patient during recovery from general anesthesia and to provide supplemental oxygen.~ISO-Gard Mask: to scavenge waste anesthetic gases from patients and provide supplemental oxygen"
635593|NCT02428413|E1|Reported Event|Standard Oxygen Mask|"Standard face mask to provide supplemental oxygen~Standard oxygen mask: Provide supplemental oxygen"
635594|NCT02428231|B3|Baseline|Total|Total of all reporting groups
635595|NCT02428231|B2|Baseline|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635596|NCT02428231|B1|Baseline|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635597|NCT02428231|P2|Participant Flow|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635598|NCT02428231|P1|Participant Flow|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg dimethyl fumarate (DMF) twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635599|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635600|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635958|NCT02419001|B2|Baseline|High Dose|1 g ceftriaxone and two high doses of SYN-004
637529|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
635601|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635602|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635603|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635604|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635605|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635606|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635607|NCT02428231|O2|Outcome|Slow Up-Titration (Six-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635608|NCT02428231|O1|Outcome|Standard Treatment (One-Week Titration)|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635609|NCT02428231|E2|Reported Event|6-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF once daily (morning dose) and placebo once daily (evening dose) for 2 weeks, then 120 mg DMF twice daily for 2 weeks, then 240 mg (as 2 120-mg capsules) DMF in the morning and 120 mg in the evening for 2 weeks, then 240 mg (as two 120-mg capsules) DMF twice daily for 6 weeks.
635610|NCT02428231|E1|Reported Event|Standard 1-Week Titration Arm|Following a 2-week placebo run-in baseline period, 120 mg DMF twice daily for 1 week, then 240 mg (as 2 120-mg capsules) DMF twice daily for 11 weeks.
635611|NCT02427984|B4|Baseline|Total|Total of all reporting groups
635612|NCT02427984|B3|Baseline|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
635613|NCT02427984|B2|Baseline|Controls|All the patients of our Division for primary THA
635614|NCT02427984|B1|Baseline|Metal on Metal (MoM)|All the patients of our Division with MoM THA
635615|NCT02427984|P3|Participant Flow|Ceramic on Ceramic (CoC)|All the patients of our Division with CoC THA
635616|NCT02427984|P2|Participant Flow|Controls|
635617|NCT02427984|P1|Participant Flow|Metal on Metal (MoM)|All the patients of our Division with MoM THA
635618|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
635619|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
635620|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
635621|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
635622|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
635623|NCT02427984|O2|Outcome|Metal on Metal (MoM)|
635624|NCT02427984|O1|Outcome|Ceramic on Ceramic (CoC)|
635625|NCT02427984|O2|Outcome|Control|
635626|NCT02427984|O1|Outcome|Metal on Metal (MoM)|
635627|NCT02427984|E3|Reported Event|Controls|
635628|NCT02427984|E2|Reported Event|Ceramic on Ceramic (CoC)|
635629|NCT02427984|E1|Reported Event|Metal on Metal (MoM)|
635630|NCT02427750|B3|Baseline|Total|Total of all reporting groups
635631|NCT02427750|B2|Baseline|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635632|NCT02427750|B1|Baseline|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635633|NCT02427750|P2|Participant Flow|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635634|NCT02427750|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635635|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635636|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635637|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635638|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635639|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635640|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635959|NCT02419001|B1|Baseline|Low Dose|1 g ceftriaxone and two low doses of SYN-004
635641|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635642|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635643|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635644|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635645|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635646|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635647|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635648|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635649|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635650|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635651|NCT02427750|O2|Outcome|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere
635652|NCT02427750|O1|Outcome|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635653|NCT02427750|E3|Reported Event|Total|
635654|NCT02427750|E2|Reported Event|TIV (≥ 61 Years)|Healthy adult subjects ≥ 61 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635655|NCT02427750|E1|Reported Event|TIV (18 to ≤ 60 Years)|Healthy adult subjects 18 to ≤ 60 years who received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2015 Southern Hemisphere.
635656|NCT02427477|B3|Baseline|Total|Total of all reporting groups
635657|NCT02427477|B2|Baseline|Delefilcon A / Senofilcon A / Delefilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
635658|NCT02427477|B1|Baseline|Senofilcon A / Delefilcon A / Senofilcon A|All subjects that randomized to receive this sequence and were dispensed a study lens.
635659|NCT02427477|P2|Participant Flow|Delefilcon A / Senofilcon A / Delefilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore delefilcon A contact lens, then wore the senofilcon A second and then wore the delefilcon A contact lens third.
635660|NCT02427477|P1|Participant Flow|Senofilcon A / Delefilcon A/ Senofilcon A|Subjects were randomly assigned to one of two lens sequences, over three lens wear periods. Subjects randomized to this sequence first wore the senofilcon A contact lens, then wore the delefilcon A contact lens second and then wore the senofilcon A contact lens third.
635661|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
635662|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
635663|NCT02427477|O2|Outcome|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
635664|NCT02427477|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
635665|NCT02427477|E2|Reported Event|Delefilcon A|Subjects that received the delefilcon A contact lens in at least one of the three study periods.
635666|NCT02427477|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in at least one of the three study periods.
635667|NCT02425826|B3|Baseline|Total|Total of all reporting groups
635668|NCT02425826|B2|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635669|NCT02425826|B1|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635670|NCT02425826|P2|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635671|NCT02425826|P1|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice a day (BID) during the placebo-controlled phase (Weeks 0-16)
635672|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635673|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635674|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635675|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635676|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
640282|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
635677|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635678|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635679|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635680|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635681|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635682|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635683|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635684|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635685|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635686|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635687|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635688|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635689|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635690|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635691|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635692|NCT02425826|O2|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635693|NCT02425826|O1|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635694|NCT02425826|E3|Reported Event|Apremilast (Weeks 0 - 52)|Includes participants initially randomized to identically matching placebo tablets in the placebo controlled phase as well as participants who were randomized to apremilast; at week 16, participants who were receiving placebo were switched to Apremilast 30 mg PO QD and received Apremilast 30 mg daily for weeks 16-52.
635695|NCT02425826|E2|Reported Event|Placebo BID|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the placebo-controlled phase (Weeks 0-16)
635696|NCT02425826|E1|Reported Event|Apremilast 30 mg BID|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the placebo-controlled phase (Weeks 0-16).
635697|NCT02423447|B1|Baseline|All Study Participants|"Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines."
635698|NCT02423447|P2|Participant Flow|G5, Then Electro-Flo|"The patients were randomized to a series of airway clearance sessions with G5 on Day 1 and Electro-Flo on Day 2.~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
635699|NCT02423447|P1|Participant Flow|Electro-Flo, Then G5|"The patients were randomized to a series of airway clearance sessions with Electro-Flo on Day 1 and G5 on Day 2.~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
635700|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
635701|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
635702|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
635703|NCT02423447|O1|Outcome|Electro-Flo Arm|Electro-Flo arm Electro-Flo device following the 2012 CFF therapy guidelines
635704|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
635705|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
635706|NCT02423447|O2|Outcome|G5 Arm|"G5 arm~G5 Intervention: An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines"
635707|NCT02423447|O1|Outcome|Electro-Flo Arm|"Electro-Flo arm~Electro-Flo Intervention: An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines"
635708|NCT02423447|O2|Outcome|G5 Flimm Fighter Arm|G5 Flimm Fighter arm
635709|NCT02423447|O1|Outcome|ElectroFlo Arm|ElectroFlo Arm
635710|NCT02423447|E2|Reported Event|G5 Flimm Fighter|G5 Flimm Fighter
635711|NCT02423447|E1|Reported Event|Electro Flo|Electro flo
635712|NCT02423408|B3|Baseline|Total|Total of all reporting groups
635960|NCT02419001|P2|Participant Flow|High Dose|1 g ceftriaxone and two high doses (150 mg) of SYN-004
635713|NCT02423408|B2|Baseline|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
635714|NCT02423408|B1|Baseline|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
635715|NCT02423408|P2|Participant Flow|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
635716|NCT02423408|P1|Participant Flow|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
635717|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
635718|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
635719|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
635720|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
635721|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
635722|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
635723|NCT02423408|O2|Outcome|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
635724|NCT02423408|O1|Outcome|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
635725|NCT02423408|E2|Reported Event|Placebo|"4 X placebo capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~Placebo: Placebo capsule"
635726|NCT02423408|E1|Reported Event|TNX-201|"4 X 35 mg capsules to be taken orally with a minimum of 4 ounces of water when qualifying tension-type headache occurs~TNX-201: TNX-201 capsule"
635727|NCT02423317|B3|Baseline|Total|Total of all reporting groups
635728|NCT02423317|B2|Baseline|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635729|NCT02423317|B1|Baseline|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635730|NCT02423317|P2|Participant Flow|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635731|NCT02423317|P1|Participant Flow|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635732|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635733|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635734|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635735|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635736|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635737|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635765|NCT02424565|O1|Outcome|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
635766|NCT02424565|E2|Reported Event|Placebo Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
635738|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635739|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635740|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635741|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635742|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635743|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635744|NCT02423317|O2|Outcome|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635745|NCT02423317|O1|Outcome|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635746|NCT02423317|E2|Reported Event|Intubation With Airtraq Laryngoscope|"After induction and muscle paralysis, Airtraq laryngoscope's blade was introduced in the patient's mouth. After visualization of vocal cord as a reflected image in the viewfinder of the device, patient was intubated with appropriate sized tracheal tube.~Intubation with Airtraq: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq."
635747|NCT02423317|E1|Reported Event|Intubation With Miller's Blade|"After induction and muscle paralysis, Miller's blade was introduced in the patient's mouth. After visualization of vocal cord, patient was intubated with appropriate sized tracheal tube.~Intubation with Miller's blade: Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade."
635748|NCT02424591|B3|Baseline|Total|Total of all reporting groups
635749|NCT02424591|B2|Baseline|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
635750|NCT02424591|B1|Baseline|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
635751|NCT02424591|P2|Participant Flow|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
635752|NCT02424591|P1|Participant Flow|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
635753|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
635754|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
635755|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
635756|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
635757|NCT02424591|O2|Outcome|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
635758|NCT02424591|O1|Outcome|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
635759|NCT02424591|E2|Reported Event|Placebo|"placebo group will have standard of care rather than ketamine infusion~Placebo: Placebo IV"
635760|NCT02424591|E1|Reported Event|Ketamine|"ketamine group will be infused after intubation and terminated at the start of skin closure~Ketamine: Infusion at a rate of 10 mcg/kg/min"
635761|NCT02424565|B1|Baseline|Overall Participants|Total number of participants randomized and treated in the study.
635762|NCT02424565|P2|Participant Flow|First Placebo Balm Then Test Balm|2 ± 0.2 g of placebo balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of test balm of 9g balm packed in each primary package .
635763|NCT02424565|P1|Participant Flow|First Test Balm Then Placebo Balm|2 ± 0.2 g of test balm of 9g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint, then a gap of 3 days as a washout period, followed by application of 2 ± 0.2 g of placebo balm of 9g balm packed in each primary package .
635764|NCT02424565|O2|Outcome|Placebo Balm|2 ± 0.2 g of placebo balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
635961|NCT02419001|P1|Participant Flow|Low Dose|1 g ceftriaxone and two low doses (75 mg) of SYN-004
635767|NCT02424565|E1|Reported Event|Test Balm|2 ± 0.2 g of test balm of 9 g balm packed in each primary package was gently rubbed for 15 seconds on the affected knee joint.
635768|NCT02424149|B3|Baseline|Total|Total of all reporting groups
635769|NCT02424149|B2|Baseline|Phenazopyridine|Preoperative phenazopyridine
635770|NCT02424149|B1|Baseline|Control|No preoperative phenazopyridine
635771|NCT02424149|P2|Participant Flow|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
635772|NCT02424149|P1|Participant Flow|Control|No preoperative phenazopyridine
635773|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
635774|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
635775|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
635776|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
635777|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
635778|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
635779|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
635780|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
635781|NCT02424149|O2|Outcome|Phenazopyridine|Preoperative oral phenazopyridine: two tablets 97.5 mg each (195 mg total)
635782|NCT02424149|O1|Outcome|Control|No preoperative phenazopyridine
635783|NCT02424149|E2|Reported Event|Phenazopyridine|Preoperative phenazopyridine
635784|NCT02424149|E1|Reported Event|Control|No preoperative phenazopyridine
635785|NCT02423993|B5|Baseline|Total|Total of all reporting groups
635786|NCT02423993|B4|Baseline|CSII + Standart Education|Patients will be transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by HbA1c. The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.
635787|NCT02423993|B3|Baseline|CSII + Group Education|"Patients will be transferred from MDI to CSII with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
635788|NCT02423993|B2|Baseline|SAP + Standart Education|Patients will be transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM will be used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month. All patients from this group should be educated about basic aspects of diabetes self-management at the School of Diabetes at least once earlier. Quality of Life (QoL) will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received
635789|NCT02423993|B1|Baseline|SAP + Group Education|"All patients will be transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life will be assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used.~We will estimate metabolic and QoL parameters in 4 months after education and transferring to CSII."
635790|NCT02423993|P4|Participant Flow|CSII + Standart Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635842|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635791|NCT02423993|P3|Participant Flow|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635792|NCT02423993|P2|Participant Flow|SAP + Standart Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635793|NCT02423993|P1|Participant Flow|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635794|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635795|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635796|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635797|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635843|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635881|NCT02421120|B1|Baseline|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635882|NCT02421120|P1|Participant Flow|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635798|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635799|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635800|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635801|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635802|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635803|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635804|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635844|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635845|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635805|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635806|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635807|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635808|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635809|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635810|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635811|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635846|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635847|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635812|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635813|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635814|NCT02423993|O4|Outcome|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635815|NCT02423993|O3|Outcome|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635816|NCT02423993|O2|Outcome|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635817|NCT02423993|O1|Outcome|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635818|NCT02423993|E4|Reported Event|CSII + Standard Education|Patients were transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) by endocrinologist-specialist in CSII or technical trainer individually and were monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. All patients from this group were educated about basic aspects of diabetes self-management earlier. Quality of Life (QoL) was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.
635848|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635849|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635819|NCT02423993|E3|Reported Event|CSII + Group Education|"Patients was transferred from MDI to CSII (Medtronic Paradigm 712) with self-monitoring of blood glucose (SMBG) using specialised structured education program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. Quality of Life was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes was used.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635820|NCT02423993|E2|Reported Event|SAP + Standard Education|Patients were transferred from MDI to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722) by endocrinologist-specialist in CSII or technical trainer individually and will be monitored by coaching specialist or local endocrinologist within 4 months prior to inclusion. CGM was used for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 months. All patients from this group were educated about basic aspects of diabetes self-management earlier. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes was assessed by HbA1c. The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency were assessed by reports received from insulin pumps. Standard Questionnaire for patients with T1D was used for the knowledge assessment about disease management.
635821|NCT02423993|E1|Reported Event|SAP + Group Education|"All patients were transferred from MDI regimen to sensor-augmented pump (Medtronic Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.) using special structured program for group education for CSII which included basic information about general diabetes self-management and technical aspects of pump therapy for 9 days. QoL was assessed using questionnaire ADDQoL, WB12, SF-36. Glycemic control effectiveness changes were assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring was estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency was assessed by reports received from insulin pumps. Standard Questionnaire for patients with type 1 diabetes was used for the knowledge assessment about disease management.~We estimated metabolic and QoL parameters in 4 months after education and transferring to CSII."
635822|NCT02423980|B3|Baseline|Total|Total of all reporting groups
635823|NCT02423980|B2|Baseline|G-Pen™ (Glucagon Injection) 0.5 mg First, Followed by 1 mg|A 0.5 mg dose of G-Pen was given at an initial clinic visit. After a 1-2 week wash-out, subjects received either a 1 mg dose of G-Pen™ at a second visit.
635824|NCT02423980|B1|Baseline|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of G-Pen was given at an initial clinic visit. After a 1-2 week wash-out, subjects received a 0.5 mg dose of G-Pen™ at a second visit.
635825|NCT02423980|P1|Participant Flow|G-Pen™ (Glucagon Injection) 1 mg First, Followed by 0.5 mg|A 1 mg dose of glucagon at an initial clinic visit, followed by a 0.5 mg dose of glucagon given at a subsequent clinic visit after a 1-2 week wash-out.
635826|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
635827|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
635828|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
635829|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
635830|NCT02423980|O2|Outcome|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
635831|NCT02423980|O1|Outcome|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
635832|NCT02423980|E2|Reported Event|Glucagon 0.5 mg|"0.5 mg G-Pen™ (glucagon injection)~Glucagon"
635833|NCT02423980|E1|Reported Event|Glucagon 1 mg|"1 mg G-Pen™ (glucagon injection)~Glucagon"
635834|NCT02421211|B3|Baseline|Total|Total of all reporting groups
635835|NCT02421211|B2|Baseline|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635836|NCT02421211|B1|Baseline|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635837|NCT02421211|P2|Participant Flow|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635838|NCT02421211|P1|Participant Flow|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635839|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635840|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635841|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
636198|NCT02415439|P9|Participant Flow|VBP15- 1.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
635850|NCT02421211|O1|Outcome|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635851|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635852|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
635853|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635854|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
635855|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635856|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
635857|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635858|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
635859|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635860|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
635861|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635862|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
635863|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635864|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
635865|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635866|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
635867|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635868|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
635869|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635870|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
635871|NCT02421211|O2|Outcome|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635872|NCT02421211|O1|Outcome|Panel 2: LDV 90mg/SOF 400mg (Day 14)|Participants received FDC tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14.
635873|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635874|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
635875|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635876|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
635877|NCT02421211|O2|Outcome|Panel 1: SMV 150mg+LDV 90mg/SOF 400mg (Day 28)|From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635878|NCT02421211|O1|Outcome|Panel 1: SMV 150 mg + SOF 400 mg (Day 14)|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14.
635879|NCT02421211|E2|Reported Event|Panel 2: SMV 150mg+LDV 90mg/SOF 400mg (8 Weeks)|Participants received fixed dose combination (FDC) tablet of 90 mg LDV/400 mg SOF, orally, once daily from Day 1 until Day 14. From Day 15 until Day 56, participants received SMV 150 mg capsule and a FDC tablet of 90 mg LDV/400 mg SOF, orally and once daily.
635880|NCT02421211|E1|Reported Event|Panel 1:SMV 150mg(SOF 400mg[2weeks]+LDV 90/SOF 400mg[8 Weeks])|Participants received simeprevir (SMV) 150 milligram (mg) capsule and sofosbuvir (SOF) 400 mg tablet, orally, once daily from Day 1 until Day 14. From Day 15 until Day 70, participants received SMV 150 mg capsule and a fixed dose combination (FDC) tablet of 90 mg Ledipasvir (LDV)/400 mg SOF, orally and once daily.
635883|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635884|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635885|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635886|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635887|NCT02421120|O1|Outcome|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635888|NCT02421120|E1|Reported Event|Ceftolozane/Tazobactam|"Ceftolozane/Tazobactam 3 grams every 8 hours intravenously for 4-6 doses~Ceftolozane/Tazobactam: 1 hour intravenous infusion"
635889|NCT02420951|B3|Baseline|Total|Total of all reporting groups
635890|NCT02420951|B2|Baseline|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635891|NCT02420951|B1|Baseline|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635892|NCT02420951|P2|Participant Flow|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635893|NCT02420951|P1|Participant Flow|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635894|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635895|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635896|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635897|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635898|NCT02420951|O2|Outcome|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635899|NCT02420951|O1|Outcome|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635900|NCT02420951|E2|Reported Event|No Injection|"Will not receive injection of bupivacaine prior to catheter removal~No Intervention: No injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635901|NCT02420951|E1|Reported Event|Injection|"Will receive injection of 30ml of .5% bupivacaine solution prior to catheter removal~Bupivacaine: Injection of local anesthetic immediately prior to catheter removal, 24 hours postop."
635902|NCT02420093|B3|Baseline|Total|Total of all reporting groups
635903|NCT02420093|B2|Baseline|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635904|NCT02420093|B1|Baseline|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
635905|NCT02420093|P2|Participant Flow|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635906|NCT02420093|P1|Participant Flow|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
635907|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635908|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
636199|NCT02415439|P8|Participant Flow|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
635909|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635910|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
635911|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635912|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
635913|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635914|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
635915|NCT02420093|O2|Outcome|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635916|NCT02420093|O1|Outcome|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
635917|NCT02420093|E2|Reported Event|Control Group|"The control group will not use the Pelvis Support Assembly per US Patent number US 8,857,906 B2 but will continue in their current sitting arrangement during the same 3 week interval"
635918|NCT02420093|E1|Reported Event|Experimental Group|"The experimental group will use the Pelvis Support Assembly per US Patent number US 8,857,906 B2, in the seat of their work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting.~Pelvis Support Assembly: Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
635919|NCT02420041|B3|Baseline|Total|Total of all reporting groups
635920|NCT02420041|B2|Baseline|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635921|NCT02420041|B1|Baseline|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635922|NCT02420041|P2|Participant Flow|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635923|NCT02420041|P1|Participant Flow|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the sacroiliac joint (SIJ)~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635941|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635924|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635925|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635926|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635927|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635928|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635929|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635930|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635931|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635932|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635933|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635934|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635935|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635936|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635937|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635938|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635939|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635940|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635957|NCT02419001|B3|Baseline|Total|Total of all reporting groups
635942|NCT02420041|O2|Outcome|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635943|NCT02420041|O1|Outcome|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635944|NCT02420041|E2|Reported Event|Ultrasound Guidance|"In Group B Ultrasound will be used to Guide Needle Placement to inject steroid into joint.~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer.~Under ultrasound guidance, a Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ."
635945|NCT02420041|E1|Reported Event|Fluoroscopic Guidance|"In Group A : Fluoroscopy will be used to Guide Needle Placement to inject Steroid into joint.~Needle entry point is in the lower one-third of the SIJ~Under fluoroscopic guidance, Havel's Inc. EchoStim 21 gauge 4 needle is inserted in a coaxial fashion into the SIJ"
635946|NCT02419313|B1|Baseline|All Study Participants|All participants included in this crossover design.
635947|NCT02419313|P2|Participant Flow|Incobotulinumtoxin A First, Then Placebo|Subjects will all receive injections with incobotulinumtoxinA injections first. At 12 weeks, these subjects will then cross over and receive placebo in the same distribution as their second treatment.
635948|NCT02419313|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Subjects will all receive injections with saline first. At 12 weeks, these subjects will then cross over and receive Xeomin in the same distribution as their second treatment.
635949|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
635950|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
635951|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
635952|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
635953|NCT02419313|O2|Outcome|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
635954|NCT02419313|O1|Outcome|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
635955|NCT02419313|E2|Reported Event|incobotulinumtoxinA, Xeomin|"Subjects will all receive injections with incobotulinumtoxinA injections, 100unit/cc into 6-10 muscles of the forearm. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. These subjects will then cross over and receive placebo ( saline) in the same distribution as their second treatment.~incobotulinumtoxinA: Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm."
635956|NCT02419313|E1|Reported Event|Placebo, Saline|"Subjects randomized to receive the placebo ( saline) will receive an equivalent volume as the active study drug (1cc). The injections will be into -10 hand and forearm muscles. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment. The subject will then cross over to an Active Intervention arm to receive incobotulinumtoxinA which will be injected in the same pattern as the saline.~Saline: same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance."
635962|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
635963|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
635964|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
635965|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
635966|NCT02419001|O2|Outcome|Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg (2 x 75 mg capsules) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
635967|NCT02419001|O1|Outcome|Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg (1 x 75 mg capsule) orally administered 30 minutes before and 5.5 hours after the start of the ceftriaxone infusion
635968|NCT02419001|E2|Reported Event|High Dose|1 g ceftriaxone and two high doses of SYN-004
635969|NCT02419001|E1|Reported Event|Low Dose|1 g ceftriaxone and two low doses of SYN-004
635970|NCT02418676|B4|Baseline|Total|Total of all reporting groups
635971|NCT02418676|B3|Baseline|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635972|NCT02418676|B2|Baseline|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635973|NCT02418676|B1|Baseline|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635974|NCT02418676|P3|Participant Flow|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635975|NCT02418676|P2|Participant Flow|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
636012|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636013|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636049|NCT02417753|E1|Reported Event|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
635976|NCT02418676|P1|Participant Flow|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635977|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635978|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635979|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635980|NCT02418676|O3|Outcome|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635981|NCT02418676|O2|Outcome|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635982|NCT02418676|O1|Outcome|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635983|NCT02418676|E3|Reported Event|Control Gel|"A quantity of 5 grams of gel without active was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Control gel: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635984|NCT02418676|E2|Reported Event|Gel With Insulin|"A quantity of 5 grams of gel with insulin was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with insulin: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635985|NCT02418676|E1|Reported Event|Gel With HPβCD-I Complex|"A quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer, previously cleaned with saline, and covered with sterile gauze and a transparent film.~Gel with HPβCD-I complex: Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with HPβCD-I complex was placed on the pressure ulcer and covered with sterile gauze and a transparent film.~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
635986|NCT02418234|B1|Baseline|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment
635987|NCT02418234|P1|Participant Flow|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
635988|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
635989|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
635990|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
635991|NCT02418234|O3|Outcome|Other Sites Failures|Other sites failures were defined as PD lesions in other distant site, or multiple sites including chest or intracranial.
635992|NCT02418234|O2|Outcome|Brain Limited|Brain limited was defined as a PD in original site or a new site of metastatic disease in brain, with no evidence of extracranial progression.
635993|NCT02418234|O1|Outcome|Chest Limited|Chest limited was defined as progressive disease (PD) in lung/pleura tissue and lymph nodes limited in chest, and no evidence of progression beyond the chest was identified.
635994|NCT02418234|O1|Outcome|TKI-PD|Patients with advanced or recurrent NSCLC who had progressed during EGFR-TKIs treatment
635995|NCT02418234|O1|Outcome|TKI-PD|
635996|NCT02418234|E1|Reported Event|TKI-PD|Patients with advanced or recurrent NSCLC patients had progressed during EGFR-TKIs treatment.
635997|NCT02418026|B3|Baseline|Total|Total of all reporting groups
635998|NCT02418026|B2|Baseline|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
635999|NCT02418026|B1|Baseline|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636000|NCT02418026|P2|Participant Flow|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636001|NCT02418026|P1|Participant Flow|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636002|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636003|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636004|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636005|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636006|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636007|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636008|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636009|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636010|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636011|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636050|NCT02417532|B1|Baseline|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636014|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636015|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636016|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636017|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636018|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636019|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636020|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636021|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636022|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636023|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636024|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636025|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636026|NCT02418026|O2|Outcome|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636027|NCT02418026|O1|Outcome|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636028|NCT02418026|E2|Reported Event|Hypnosis|"women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from a hypnosis session during the surgery in addition to general care~hypnosis: Conversational hypnotic induction and therapeutic suggestions"
636029|NCT02418026|E1|Reported Event|Control|women who attended the obstetrics department for a scheduled or unplanned cesarean section and who benefited from general care
636030|NCT02417961|B1|Baseline|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636031|NCT02417961|P1|Participant Flow|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636032|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636033|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636034|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636035|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636036|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636037|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636038|NCT02417961|O1|Outcome|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636039|NCT02417961|E1|Reported Event|Benra 30 mg|Benralizumab administered subcutaneously every 4 weeks
636040|NCT02417753|B1|Baseline|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636041|NCT02417753|P1|Participant Flow|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636042|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636043|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636044|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636045|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636046|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636047|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
636048|NCT02417753|O1|Outcome|AZD9150 in People With Malignant Ascites|"AZD9150 over a 28 day cycle~AZD9150: AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle"
637524|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
636051|NCT02417532|P1|Participant Flow|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636052|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636053|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636054|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636055|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636056|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636057|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636058|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636059|NCT02417532|O1|Outcome|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636060|NCT02417532|E1|Reported Event|Rehabilitation Using REX|"Exercises using Rex mobility assist device~Rehabilitation using REX: Exercises of wheelchair dependent subjects using REX"
636061|NCT02417376|B3|Baseline|Total|Total of all reporting groups
636062|NCT02417376|B2|Baseline|Control|No periodontal intervention in any form.
636063|NCT02417376|B1|Baseline|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636064|NCT02417376|P2|Participant Flow|Control|No periodontal intervention in any form.
636065|NCT02417376|P1|Participant Flow|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636066|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636067|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636068|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636069|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636070|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636071|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636072|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636134|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
636161|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636073|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636074|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636075|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636076|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636077|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636078|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636079|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636080|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636081|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636082|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636083|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636084|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636085|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636086|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636087|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636088|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636089|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636090|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636091|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636092|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636093|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636094|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636095|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636096|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636097|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636098|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636099|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636100|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636101|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636102|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636103|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636104|NCT02417376|O2|Outcome|Control|No periodontal intervention in any form.
636105|NCT02417376|O1|Outcome|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636106|NCT02417376|E2|Reported Event|Control|No periodontal intervention in any form.
636107|NCT02417376|E1|Reported Event|Experimental|"Periodontal intervention in the form of scaling and root planing by:~ultrasonic piezoelectric scaler (frequency of 28-36 KHz) and~gracey curets (set of 7 instruments number 1-14) to remove supra and subgingival calculus on teeth, is completed in two appointments of 45 to 60 min, within 24 hours~piezoelectric ultrasonic scaler (frequency of 28-36 KHz): Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.~Gracey curettes: set of 7 instruments number #1-14"
636108|NCT02417129|B1|Baseline|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636109|NCT02417129|P2|Participant Flow|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636110|NCT02417129|P1|Participant Flow|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636111|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636112|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636113|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636114|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636115|NCT02417129|O2|Outcome|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636116|NCT02417129|O1|Outcome|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636117|NCT02417129|E2|Reported Event|Rituximab (US-licensed Rituxan)|Patients received an infusion of 375 milligram (mg)/square meter (m2) of rituximab once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636118|NCT02417129|E1|Reported Event|BI 695500|Patients received an infusion of 375 milligram (mg)/square meter (m2) of BI 695500 once a week intravenously for 4 weeks treatment. These 4 dosages were administered on Days 1, 8, 15, and 22 with 26 weeks follow-up.
636119|NCT02416973|B4|Baseline|Total|Total of all reporting groups
636120|NCT02416973|B3|Baseline|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
636121|NCT02416973|B2|Baseline|Active Treatment|"Active Provant Treatment~Provant"
636122|NCT02416973|B1|Baseline|Sham of Provant|"Sham of Provant~Provant"
636123|NCT02416973|P3|Participant Flow|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
636124|NCT02416973|P2|Participant Flow|Active Treatment|"Active Provant Treatment~Provant"
636125|NCT02416973|P1|Participant Flow|Sham of Provant|"Sham of Provant~Provant"
636126|NCT02416973|O3|Outcome|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
636127|NCT02416973|O2|Outcome|Active Treatment|"Active Provant Treatment~Provant"
636128|NCT02416973|O1|Outcome|Sham of Provant|"Sham of Provant~Provant"
636129|NCT02416973|E3|Reported Event|Active Treatment With Alternative Settings|"Active Provant Treatment with alternative settings~Provant"
636130|NCT02416973|E2|Reported Event|Active Treatment|"Active Provant Treatment~Provant"
636131|NCT02416973|E1|Reported Event|Sham of Provant|"Sham of Provant~Provant"
636132|NCT02416180|B1|Baseline|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
636133|NCT02416180|P1|Participant Flow|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via metered dose inhaler (MDI) for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI Patient Information Leaflet (PIL) and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
636197|NCT02415439|P10|Participant Flow|VBP15- 3.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
636135|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
636136|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
636137|NCT02416180|O1|Outcome|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
636138|NCT02416180|E1|Reported Event|Fluticasone Propionate/Salmeterol MDI|Participants received fluticasone propionate/salmeterol via MDI for 14 days at a dose equivalent to their pre-study fluticasone propionate/salmeterol dose which was administered via DISKUS inhaler. Participants were instructed to read the fluticasone propionate/salmeterol MDI PIL and then to use the provided MDI in accordance with the PIL for approximately 14 days, in replacement of their DISKUS inhaler.
636139|NCT02415959|B6|Baseline|Total|Total of all reporting groups
636140|NCT02415959|B5|Baseline|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636141|NCT02415959|B4|Baseline|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636142|NCT02415959|B3|Baseline|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636143|NCT02415959|B2|Baseline|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636144|NCT02415959|B1|Baseline|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636145|NCT02415959|P5|Participant Flow|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636146|NCT02415959|P4|Participant Flow|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636147|NCT02415959|P3|Participant Flow|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636148|NCT02415959|P2|Participant Flow|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636149|NCT02415959|P1|Participant Flow|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636150|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636151|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636152|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636153|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636154|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636155|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636156|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636157|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636158|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636159|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636160|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636380|NCT02413034|E2|Reported Event|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
636162|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636163|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636164|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636165|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636166|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636167|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636168|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636169|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636170|NCT02415959|O5|Outcome|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636171|NCT02415959|O4|Outcome|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636172|NCT02415959|O3|Outcome|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636173|NCT02415959|O2|Outcome|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636174|NCT02415959|O1|Outcome|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636175|NCT02415959|E5|Reported Event|Creon® (DR/GR)|"Creon® (DR/GR) 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon® (DR/GR)"
636176|NCT02415959|E4|Reported Event|Creon IR Maximum Dose|"Creon IR 4,000 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 400,000 lipase units)~Creon IR"
636177|NCT02415959|E3|Reported Event|Creon IR High Dose|"Creon IR 2,400 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 240,000 lipase units)~Creon IR"
636178|NCT02415959|E2|Reported Event|Creon IR Medium Dose|"Creon IR 1,200 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 120,000 lipase units)~Creon IR"
636179|NCT02415959|E1|Reported Event|Creon IR Low Dose|"Creon IR 300 Ph. Eur. U lipase/g fat, proportionally administered five times daily (during 3 meals and 2 snacks) for 6 to 7 days (target total daily dose of 30,000 lipase units)~Creon IR"
636180|NCT02415439|B14|Baseline|Total|Total of all reporting groups
636181|NCT02415439|B13|Baseline|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions
636182|NCT02415439|B12|Baseline|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions
636183|NCT02415439|B11|Baseline|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions
636184|NCT02415439|B10|Baseline|VBP15 - 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions
636185|NCT02415439|B9|Baseline|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions
636186|NCT02415439|B8|Baseline|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions
636187|NCT02415439|B7|Baseline|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions
636188|NCT02415439|B6|Baseline|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal
636189|NCT02415439|B5|Baseline|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions
636190|NCT02415439|B4|Baseline|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions
636191|NCT02415439|B3|Baseline|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions
636192|NCT02415439|B2|Baseline|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions
636193|NCT02415439|B1|Baseline|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions
636194|NCT02415439|P13|Participant Flow|Placebo MAD|Subjects were orally administered placebo daily for 14 days under fasted conditions.
636195|NCT02415439|P12|Participant Flow|VBP15- 20 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
636196|NCT02415439|P11|Participant Flow|VBP15- 9.0 mg/kg 14 Day MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
636381|NCT02413034|E1|Reported Event|Control Group|No antibiotic prophylaxis
636200|NCT02415439|P7|Participant Flow|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 20.0 mg/kg under fasted conditions.
636201|NCT02415439|P6|Participant Flow|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high fat/high calorie meal.
636202|NCT02415439|P5|Participant Flow|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
636203|NCT02415439|P4|Participant Flow|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
636204|NCT02415439|P3|Participant Flow|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
636205|NCT02415439|P2|Participant Flow|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636206|NCT02415439|P1|Participant Flow|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
636207|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
636208|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
636209|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
636210|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
636211|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
636212|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
636213|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
636214|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
636215|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
636216|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
636217|NCT02415439|O5|Outcome|Placebo MAD|Subjects were orally admistered placebo daily for 14 days under fasted conditions.
636218|NCT02415439|O4|Outcome|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
636219|NCT02415439|O3|Outcome|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
636220|NCT02415439|O2|Outcome|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
636221|NCT02415439|O1|Outcome|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
636222|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
636223|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636224|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
636225|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
636226|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
636227|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
636228|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636229|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
636230|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
636231|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636232|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
636233|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasted SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
636234|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
636235|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
636236|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636237|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
636238|NCT02415439|O8|Outcome|Placebo SAD|Subjects were administered a single dose of placebo under fasted conditions.
636239|NCT02415439|O7|Outcome|VBP15- 20.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636240|NCT02415439|O6|Outcome|VBP15- 8.0 mg/kg Fed SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
636241|NCT02415439|O5|Outcome|VBP15- 8.0 mg/kg Fasting SAD|Subjects were administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
636242|NCT02415439|O4|Outcome|VBP15- 3.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
636243|NCT02415439|O3|Outcome|VBP15- 1.0 mg/kg SAD|Subjects were administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
636244|NCT02415439|O2|Outcome|VBP15- 0.3 mg/kg SAD|Subjects were administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636245|NCT02415439|O1|Outcome|VBP15- 0.1 mg/kg SAD|Subjects were administered single dose of VBP15 at 0.1 mg/kg under fasted conditions.
636382|NCT02412657|B4|Baseline|Total|Total of all reporting groups
636246|NCT02415439|E13|Reported Event|Placebo MAD|Subjects were orally administered a dose of placebo daily for 14 days under fasted conditions.
636247|NCT02415439|E12|Reported Event|VBP15- 20.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 20.0 mg/kg daily for 14 days under fasted conditions.
636248|NCT02415439|E11|Reported Event|VBP15- 9.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 9.0 mg/kg daily for 14 days under fasted conditions.
636249|NCT02415439|E10|Reported Event|VBP15- 3.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 3.0 mg/kg daily for 14 days under fasted conditions.
636250|NCT02415439|E9|Reported Event|VBP15- 1.0 mg/kg 14 Days MAD|Subjects were orally administered a dose of VBP15 at 1.0 mg/kg daily for 14 days under fasted conditions.
636251|NCT02415439|E8|Reported Event|Placebo SAD|Subjects were orally administered a single dose of placebo under fasted conditions.
636252|NCT02415439|E7|Reported Event|VBP15- 20.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636253|NCT02415439|E6|Reported Event|VBP15- 8.0 mg/kg Fed SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg within 30 minutes of beginning a high-fat/high calorie meal.
636254|NCT02415439|E5|Reported Event|VBP15- 8.0 mg/kg Fasted SAD|Subjects were orally administered a single dose of VBP15 at 8.0 mg/kg under fasted conditions.
636255|NCT02415439|E4|Reported Event|VBP15- 3.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 3.0 mg/kg under fasted conditions.
636256|NCT02415439|E3|Reported Event|VBP15- 1.0 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 1.0 mg/kg under fasted conditions.
636257|NCT02415439|E2|Reported Event|VBP15- 0.3 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.3 mg/kg under fasted conditions.
636258|NCT02415439|E1|Reported Event|VBP15- 0.1 mg/kg SAD|Subjects were orally administered a single dose of VBP15 at 0.1 mg/kg under fasted conditions.
636259|NCT02414828|B5|Baseline|Total|Total of all reporting groups
636260|NCT02414828|B4|Baseline|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636261|NCT02414828|B3|Baseline|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636262|NCT02414828|B2|Baseline|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636263|NCT02414828|B1|Baseline|Placebo|Sterile buffer, Intramuscular (IM)
636264|NCT02414828|P4|Participant Flow|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636265|NCT02414828|P3|Participant Flow|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636266|NCT02414828|P2|Participant Flow|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636267|NCT02414828|P1|Participant Flow|Placebo|Sterile buffer, Intramuscular (IM)
636268|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636269|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636270|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636271|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
636272|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636273|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636274|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636275|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
636276|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636277|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636278|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636279|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
636280|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636281|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636282|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636283|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
636284|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636285|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636286|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636287|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
636288|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636289|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636290|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636291|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
636292|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636293|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636294|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636295|NCT02414828|O1|Outcome|Placebo|Sterile buffer, IM
636296|NCT02414828|O4|Outcome|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636297|NCT02414828|O3|Outcome|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636298|NCT02414828|O2|Outcome|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636299|NCT02414828|O1|Outcome|Placebo|Sterile Buffer, Intramuscular (IM)
636300|NCT02414828|E4|Reported Event|AERAS-402 3 x 10^10 vp|AERAS-402, 2 x IM, study days 0 and 42
636301|NCT02414828|E3|Reported Event|AERAS-402 3 x 10^9 vp|AERAS-402, 1 x IM, study day 0
636302|NCT02414828|E2|Reported Event|AERAS-402 3 x 10^8 vp|AERAS-402, 1 x IM, study day 0
636303|NCT02414828|E1|Reported Event|Placebo|Sterile buffer, Intramuscular (IM)
636304|NCT02414152|B1|Baseline|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
636305|NCT02414152|P1|Participant Flow|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
637525|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
636306|NCT02414152|O1|Outcome|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
636307|NCT02414152|E1|Reported Event|Anakinra|"100mg of Anakinra administered as a daily subcutaneous injection~anakinra: 100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response"
636308|NCT02413593|B1|Baseline|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636309|NCT02413593|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636310|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636311|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636312|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636313|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636314|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636315|NCT02413593|O1|Outcome|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636316|NCT02413593|E1|Reported Event|LDV/SOF+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
636317|NCT02413333|B5|Baseline|Total|Total of all reporting groups
636318|NCT02413333|B4|Baseline|PeroxiClear, Then PeroxiClear|PeroxiClear was used in Period 1 and in Period 2.
636319|NCT02413333|B3|Baseline|Clear Care Plus, Then Clear Care Plus|Clear Care Plus was used in Period 1 and in Period 2.
636320|NCT02413333|B2|Baseline|PeroxiClear, Then Clear Care Plus|PeroxiClear was used in Period 1, then Clear Care Plus in Period 2.
636321|NCT02413333|B1|Baseline|Clear Care Plus, Then PeroxiClear|Clear Care Plus was used in Period 1, then PeroxiClear in Period 2.
636322|NCT02413333|P2|Participant Flow|PeroxiClear, Then Clear Care Plus|PeroxiClear contact lens solution in Period 1, followed by Clear Care Plus contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
636323|NCT02413333|P1|Participant Flow|Clear Care Plus, Then PeroxiClear|Clear Care Plus contact lens solution in Period 1, followed by PeroxiClear contact lens solution in Period 2. Each product used daily per packaging instructions with participant's habitual silicone hydrogel contact lenses for approximately 30 cleaning cycles.
636324|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
636325|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
636326|NCT02413333|O2|Outcome|Clear Care Plus|Clear Care Plus Lens Cases
636327|NCT02413333|O1|Outcome|PeroxiClear|PeroxiClear Lens Cases
636328|NCT02413333|E2|Reported Event|Clear Care Plus|While using Clear Care Plus
636329|NCT02413333|E1|Reported Event|PeroxiClear|While using PeroxiClear
636330|NCT02413294|B1|Baseline|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636331|NCT02413294|P1|Participant Flow|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636332|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636333|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636334|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636556|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636335|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636336|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636337|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636338|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636339|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636340|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636341|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636342|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636343|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636344|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636345|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636557|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636346|NCT02413294|O1|Outcome|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636347|NCT02413294|E1|Reported Event|Bright Light Intervention|"Before the bright light intervention is initiated (and during the intervention), participants will wear two wrist bands which measure sleep quality and activity levels- the Fitbit and actigraphy watches. These will be worn for two weeks to assess individuals’ baseline levels of sleep quality and will continue to be worn during the intervention. Following the baseline period, the re-timer glasses will be introduced and worn for a period of 30 to 50 minutes a day for two weeks.~Re-Timer glasses: Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study."
636348|NCT02413203|B3|Baseline|Total|Total of all reporting groups
636349|NCT02413203|B2|Baseline|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636350|NCT02413203|B1|Baseline|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636351|NCT02413203|P2|Participant Flow|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636352|NCT02413203|P1|Participant Flow|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636353|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636354|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636355|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636356|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636357|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636358|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636359|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636360|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636361|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636362|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636363|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636364|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636365|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636366|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636367|NCT02413203|O2|Outcome|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636368|NCT02413203|O1|Outcome|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636369|NCT02413203|E2|Reported Event|Placebo|"Oral administration of a single placebo pill.~Placebo: Blood and urine collections before and 3 hours after placebo administration."
636370|NCT02413203|E1|Reported Event|Celecoxib|"Oral administration of a single pill of celecoxib (200 mg). Celecoxib pills will be over-encapsulated to match the placebo.~Celecoxib: Blood and urine collections before and 3 hours after celecoxib administration."
636371|NCT02413034|B3|Baseline|Total|Total of all reporting groups
636372|NCT02413034|B2|Baseline|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
636373|NCT02413034|B1|Baseline|Control Group|No antibiotic prophylaxis
636374|NCT02413034|P2|Participant Flow|Study Group|Cefazolin: Cefazolin (vancomycin in the case of allergy to cefazolin)
636375|NCT02413034|P1|Participant Flow|Control Group|No antibiotic prophylaxis
636376|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
636377|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
636378|NCT02413034|O2|Outcome|Study Group|Cefazolin prophylaxis (vancomycin in the case of allergy to cefazolin)
636379|NCT02413034|O1|Outcome|Control Group|No antibiotic prophylaxis
636383|NCT02412657|B3|Baseline|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
636384|NCT02412657|B2|Baseline|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636385|NCT02412657|B1|Baseline|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636386|NCT02412657|P3|Participant Flow|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
636387|NCT02412657|P2|Participant Flow|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636388|NCT02412657|P1|Participant Flow|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636389|NCT02412657|O3|Outcome|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
636390|NCT02412657|O2|Outcome|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636391|NCT02412657|O1|Outcome|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636392|NCT02412657|E3|Reported Event|Normal Saline 20 mL Intravenous|"Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Normal Saline"
636393|NCT02412657|E2|Reported Event|Dexamethasone 4 mg Intravenous|"Dexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636394|NCT02412657|E1|Reported Event|Dexamethasone 10 mg Intravenous|"Dexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block~Dexamethasone: After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v."
636395|NCT02411201|B1|Baseline|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636396|NCT02411201|P1|Participant Flow|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636397|NCT02411201|O2|Outcome|Pre- + Post-contrast|Lesion visualization was assessed after DOTAREM injection
636398|NCT02411201|O1|Outcome|Pre-contrast|Lesion visualization was assessed before DOTAREM injection
636399|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636400|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636401|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636402|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636403|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636404|NCT02411201|O1|Outcome|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636405|NCT02411201|E1|Reported Event|DOTAREM|Subjects receiving a single intravenous injection of 0.1 mmol/kg body weight of DOTAREM
636406|NCT02411929|B1|Baseline|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
636435|NCT02411929|E1|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
636436|NCT02411747|B3|Baseline|Total|Total of all reporting groups
636558|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636407|NCT02411929|P1|Participant Flow|Ertugliflozin|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose. → Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart). Dosing in Periods 1 and 2 will be separated by a washout of at least 11 days.
636408|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
636409|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
636410|NCT02411929|O2|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart).
636411|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug IV|Period 1: Oral dose of 15 mg unlabeled ertugliflozin + intravenous (IV) dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. The 14^C IV dose will be administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose.
636412|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636413|NCT02411929|O1|Outcome|14^C-Ertugliflozin 100 ug Oral|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C administered orally after the unlabeled oral dose (no more than 5 minutes apart) on Day 1 of Period 2.
636414|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636415|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636416|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636417|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636418|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636419|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636420|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636421|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636422|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636423|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636424|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636425|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636426|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636427|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636428|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636429|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636430|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636431|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636432|NCT02411929|O2|Outcome|14^C-Ertugliflozin 100 ug IV|100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C IV administered as an infusion over approximately 5 minutes starting at 55 minutes after the unlabeled oral dose on Day 1 of Period 1.
636433|NCT02411929|O1|Outcome|Unlabeled Ertugliflozin 15 mg Oral|Oral dose of 15 mg unlabeled ertugliflozin on Day 1 of Period 1
636434|NCT02411929|E2|Reported Event|Unlabeled Ertugliflozin 15 mg Oral + 14^C-Ert. 100 ug Oral|Period 2: Oral dose 15 mg unlabeled ertugliflozin + oral dose of 100 µg 14^C-labeled ertugliflozin containing approximately 400 nCi 14^C. Both the unlabeled and 14^C-ertugliflozin will be administered at the same time (no more than 5 minutes apart.)
636437|NCT02411747|B2|Baseline|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy by simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by a expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
636438|NCT02411747|B1|Baseline|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with a expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
636439|NCT02411747|P2|Participant Flow|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
636440|NCT02411747|P1|Participant Flow|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
636441|NCT02411747|O2|Outcome|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
636442|NCT02411747|O1|Outcome|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
636443|NCT02411747|E2|Reported Event|Oral Lecture+Simulation Training|"Endoscopic training in flexible cystoscopy simulation training, max. time cap 1h45min after a 15 minute oral theoretical lecture by an expert in the procedure. Total max. time: 2 hours.~Oral expert lecture Simulation training"
636444|NCT02411747|E1|Reported Event|Directed Self-regulated Simulation Training+Testing|"Endoscopic training in flexible cystoscopy by directed self-regulated training with knowledge of a test afterwards, max. time cap 1h45min. 15 minutes of testing with an expert in the procedure. Total max time: 2 hours.~Directed self-regulated simulation training Testing"
636445|NCT02410824|B1|Baseline|Overall Baseline Characteristics|Participants were randomized to wear stenfilcon A toric lens or etafilcon A toric lens bilaterally for one week, then cross over to the alternative pair.
636446|NCT02410824|P2|Participant Flow|Etafilcon A Toric Lens, Then Stenfilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week, then cross over to the stenfilcon A toric lens.~etafilcon A: toric contact lens~stenfilcon A: toric contact lens"
636447|NCT02410824|P1|Participant Flow|Stenfilcon A Toric Lens, Then Etafilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week, then cross over to the etafilcon A toric lens.~stenfilcon A: toric contact lens~etafilcon A: toric contact lens"
636448|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636449|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636450|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636451|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636452|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636453|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636454|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636455|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636456|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636457|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636458|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636459|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636460|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636461|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636462|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636463|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636464|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636465|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636466|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636467|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636468|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
640283|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
636469|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric lens contact lens"
636470|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636471|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636472|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636473|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636474|NCT02410824|O2|Outcome|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636475|NCT02410824|O1|Outcome|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636476|NCT02410824|E2|Reported Event|Etafilcon A Toric Lens|"Participants were randomized to wear etafilcon A toric lens for one week during the cross over study.~etafilcon A: toric contact lens"
636477|NCT02410824|E1|Reported Event|Stenfilcon A Toric Lens|"Participants were randomized to wear stenfilcon A toric lens for one week during the cross over study.~stenfilcon A: toric contact lens"
636478|NCT02410291|B3|Baseline|Total|Total of all reporting groups
636479|NCT02410291|B2|Baseline|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
636480|NCT02410291|B1|Baseline|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
636481|NCT02410291|P2|Participant Flow|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
636482|NCT02410291|P1|Participant Flow|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
636483|NCT02410291|O2|Outcome|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
636484|NCT02410291|O1|Outcome|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
636508|NCT02408692|O3|Outcome|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
636485|NCT02410291|E2|Reported Event|Control Group|Patients in this group will receive the standard care to prepare them for their planning CT scan. They will be presented with the flyer at the consultation. A few days before the CT appointment, patients in this group will also be called and reminded about the required preparations, but will not be told about the video. In addition to the statistics about patient preparedness collected by the radiation therapist conducting the CT scan and stored and secured in an OCC Pinnacle planning system, we will also evaluate: patients’ satisfaction with the preparation instructions, their knowledge (knowledge questionnaire) about the video content and importance of understanding the rectal emptying procedures, and radiation therapists’ satisfaction with patients’ rectal preparation.
636486|NCT02410291|E1|Reported Event|Experimental Group|"Patients will receive the standard are to prepare them for their planning CT scan. They will be presented with the flyer that will be developed based on information about the importance of rectal and bladder preparation that is currently provided to patients and will also watch a youtube video on how to prepare for their CT simulation appointment. A few days before the CT planning appointment, patients in this group will be called by the radiation therapist or RA, reminding them about the rectal preparation for the appointment. Each patient will also be reminded to watch the instructional video on YouTube. Patients will be asked not to share the video link with other patients during the study.~Educational video: Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video"
636487|NCT02410200|B1|Baseline|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636488|NCT02410200|P1|Participant Flow|BG00012|BG00012 taken orally at a dose of 120 mg twice daily (BID) for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636489|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636490|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636491|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636492|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636493|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636494|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636495|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636496|NCT02410200|O1|Outcome|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636497|NCT02410200|E1|Reported Event|BG00012|BG00012 taken orally at a dose of 120 mg BID for the first 7 days and at a dose of 240 mg BID thereafter for 24 weeks.
636498|NCT02408692|B4|Baseline|Total|Total of all reporting groups
636499|NCT02408692|B3|Baseline|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
636500|NCT02408692|B2|Baseline|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636501|NCT02408692|B1|Baseline|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636502|NCT02408692|P3|Participant Flow|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
636503|NCT02408692|P2|Participant Flow|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636504|NCT02408692|P1|Participant Flow|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636505|NCT02408692|O3|Outcome|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
636506|NCT02408692|O2|Outcome|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636507|NCT02408692|O1|Outcome|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636509|NCT02408692|O2|Outcome|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636510|NCT02408692|O1|Outcome|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636511|NCT02408692|E3|Reported Event|Obese BMI ECx2|"5 obese women (BMI >30 kg/m2) taking 3mg LNG~ECx2: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)"
636512|NCT02408692|E2|Reported Event|Obese BMI ECx1|"5 obese women (BMI >30 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636513|NCT02408692|E1|Reported Event|Normal BMI ECx1|"5 normal weight women (BMI<25 kg/m2) taking 1.5mg LNG~ECx1: At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation."
636514|NCT02406937|B4|Baseline|Total|Total of all reporting groups
636515|NCT02406937|B3|Baseline|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636516|NCT02406937|B2|Baseline|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636517|NCT02406937|B1|Baseline|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636518|NCT02406937|P3|Participant Flow|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636519|NCT02406937|P2|Participant Flow|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636520|NCT02406937|P1|Participant Flow|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636521|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Breast Feeding: Oral intake of breast milk"
636522|NCT02406937|O2|Outcome|Feihe Stage 1 Formula|"Oral intake of Feihe stage 1 formula~Oral intake of Feihe Stage 1 Formula: Oral intake of Feihe Stage 1 Formula"
636523|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake of Feihe New Formula: Oral intake of Feihe New Formula"
636524|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636525|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636526|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636527|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636528|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636529|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636530|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636531|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636532|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636533|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636534|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636535|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636536|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636537|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636538|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636539|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636540|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636541|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636542|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636543|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636544|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636545|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636546|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636547|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636548|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636549|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636550|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636551|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636552|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636553|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636554|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636555|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
637526|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
636559|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636560|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636561|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636562|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636563|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636564|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636565|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636566|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636567|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636568|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636569|NCT02406937|O3|Outcome|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636570|NCT02406937|O2|Outcome|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636571|NCT02406937|O1|Outcome|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636572|NCT02406937|E3|Reported Event|Breast Feeding|"Oral intake of breast milk~Oral intake: Oral intake"
636573|NCT02406937|E2|Reported Event|Feihe Formula|"Oral intake of Feihe stage 1 formula~Oral intake: Oral intake"
636574|NCT02406937|E1|Reported Event|Feihe New Formula|"Oral intake of Feihe new formula with hydrolyzed protein supplied by Arla Foods Ingredients.~Oral intake: Oral intake"
636575|NCT02406586|B4|Baseline|Total|Total of all reporting groups
636576|NCT02406586|B3|Baseline|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636577|NCT02406586|B2|Baseline|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636578|NCT02406586|B1|Baseline|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636579|NCT02406586|P3|Participant Flow|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636580|NCT02406586|P2|Participant Flow|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636581|NCT02406586|P1|Participant Flow|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636582|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636583|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636584|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636585|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636586|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636644|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636645|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636587|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636588|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636589|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636590|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636591|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636592|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636593|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636594|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636595|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636596|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636597|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636598|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636599|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636600|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636601|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636602|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636603|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636646|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636604|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636605|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636606|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636607|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636608|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636609|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636610|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636611|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636612|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636613|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636614|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636615|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636616|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636617|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636618|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636619|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636620|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
637527|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
636621|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636622|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636623|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636624|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636625|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636626|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636627|NCT02406586|O3|Outcome|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636628|NCT02406586|O2|Outcome|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636629|NCT02406586|O1|Outcome|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636630|NCT02406586|E3|Reported Event|Placebo|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one placebo tablet twice daily for two weeks. The dose was increased to two placebo tablets twice daily for the remaining four weeks. The subjects also receive another 24-hour IV administration of Intralipid 20% at the 6-week point.
636631|NCT02406586|E2|Reported Event|Carvedilol|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one carvedilol 3.125 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two carvedilol 3.125 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636632|NCT02406586|E1|Reported Event|Salsalate|Obese, normotensive, healthy subjects received an intravenous (IV) administration of Intralipid 20% for 24 hours, and then one salsalate 750 mg tablet twice daily for two weeks. If the subject had no side effects, the dose was increased to two salsalate 750 mg tablets twice daily for the remaining four weeks. The subjects also received another 24-hour IV administration of Intralipid 20% at the 6-week point.
636633|NCT02406495|B1|Baseline|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636634|NCT02406495|P1|Participant Flow|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636635|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636636|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636637|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636638|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636639|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636640|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636641|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636642|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636643|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636647|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636648|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636649|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636650|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636651|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636652|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636653|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636654|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636655|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636656|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636657|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636658|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636659|NCT02406495|O4|Outcome|Ocufilcon D OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636660|NCT02406495|O3|Outcome|Ocufilcon D OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636661|NCT02406495|O2|Outcome|Filcon IV 1 OS|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636662|NCT02406495|O1|Outcome|Filcon IV 1 OD|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636663|NCT02406495|O4|Outcome|Ocufilcon D OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636664|NCT02406495|O3|Outcome|Ocufilcon D OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636665|NCT02406495|O2|Outcome|Filcon IV 1 OS (Oculus Sinister)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636666|NCT02406495|O1|Outcome|Filcon IV 1 OD (Oculus Dexter)|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636667|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636668|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636669|NCT02406495|O2|Outcome|Ocufilcon D|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636670|NCT02406495|O1|Outcome|Filcon IV 1|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636671|NCT02406495|E1|Reported Event|Overall Participants|"Habitual wearers of (FILCON IV 1) sphere lenses refitted with asphere ocufilcon D lenses.~filcon IV 1: contact lens~ocufilcon D: contact lens"
636672|NCT02405429|B1|Baseline|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636673|NCT02405429|P1|Participant Flow|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636674|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636675|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636676|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636677|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636678|NCT02405429|O1|Outcome|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636679|NCT02405429|E1|Reported Event|Hospitalized Neonates|Patients in the neonatal intensive care unit or the newborn nursery
636680|NCT02405390|B3|Baseline|Total|Total of all reporting groups
636681|NCT02405390|B2|Baseline|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
636682|NCT02405390|B1|Baseline|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
636683|NCT02405390|P2|Participant Flow|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
636684|NCT02405390|P1|Participant Flow|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
636685|NCT02405390|O2|Outcome|Direct Laryngoscopy|Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
636686|NCT02405390|O1|Outcome|Video Laryngoscopy|Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
636687|NCT02405390|O2|Outcome|Direct Laryngoscopy|Some patients will be intubated with a direct (conventional) laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
636688|NCT02405390|O1|Outcome|Video Laryngoscopy|Some patients will be intubated with a video laryngoscope. Head motion (extension, Flexion, Roation Right and Rotation Left) will be measured by using Polhemus Patriot™ electromagnetic tracking system
636689|NCT02405390|E2|Reported Event|Direct Laryngoscopy|"Some patients will be intubated with a direct (conventional) laryngoscope~Direct Laryngoscopy: Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords~Storz C-Mac® laryngoscope"
636690|NCT02405390|E1|Reported Event|Video Laryngoscopy|"Some patients will be intubated with a video laryngoscope~Video Laryngoscopy: Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system~Storz C-Mac® laryngoscope"
636691|NCT02404649|B3|Baseline|Total|Total of all reporting groups
636692|NCT02404649|B2|Baseline|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
636693|NCT02404649|B1|Baseline|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
636694|NCT02404649|P2|Participant Flow|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
636695|NCT02404649|P1|Participant Flow|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
636696|NCT02404649|O2|Outcome|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
636697|NCT02404649|O1|Outcome|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
636732|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636733|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636698|NCT02404649|E2|Reported Event|Sinus Elevation Only|"Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.~sinus elevation only"
636699|NCT02404649|E1|Reported Event|Bone Augmention|"Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Thickness of bone surrounding implant body positioned in the sinus will be measured.~Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.~sinus bone augmentation"
636700|NCT02404493|B3|Baseline|Total|Total of all reporting groups
636701|NCT02404493|B2|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636702|NCT02404493|B1|Baseline|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636703|NCT02404493|P2|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636704|NCT02404493|P1|Participant Flow|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636705|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636706|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636707|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636708|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636709|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636710|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636711|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636712|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636713|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636714|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636715|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636716|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636717|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636718|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636719|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636720|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636721|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636722|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636723|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636724|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636725|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636726|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636727|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636728|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636729|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636730|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636731|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636734|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636735|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636736|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636737|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636738|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636739|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636740|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636741|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636742|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636743|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636744|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636745|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636746|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636747|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636748|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636749|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636750|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636751|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636752|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636753|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636754|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636755|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636756|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636757|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636758|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636759|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636760|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636761|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636762|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636763|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636764|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636765|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636766|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636767|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636768|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636769|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636770|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636771|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636772|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636773|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636774|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
637528|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
636775|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636776|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636777|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636778|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636779|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636780|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636781|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636782|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636783|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636784|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636785|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636786|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636787|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636788|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636789|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636790|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636791|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636792|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636793|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636794|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636795|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636796|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636797|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636798|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636799|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636800|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636801|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636802|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636803|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636804|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636805|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636806|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636807|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636808|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636809|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636810|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636811|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636812|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636813|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636814|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636815|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
637578|NCT02392767|B3|Baseline|Total|Total of all reporting groups
636816|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636817|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636818|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636819|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636820|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636821|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636822|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636823|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636824|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636825|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636826|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636827|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636828|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636829|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636830|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636831|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636832|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636833|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636834|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636835|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636836|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636837|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636838|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636839|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636840|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636841|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636842|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636843|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636844|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636845|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636846|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636847|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636848|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636849|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636850|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636851|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636852|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636853|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636854|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636855|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636856|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
638451|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
636857|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636858|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636859|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636860|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636861|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636862|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636863|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636864|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636865|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636866|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636867|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636868|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636869|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636870|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636871|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636872|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636873|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636874|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636875|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636876|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636877|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636878|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636879|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636880|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636881|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636882|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636883|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636884|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636885|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636886|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636887|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636888|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636889|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636890|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636891|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636892|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636893|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636894|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636895|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636896|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636897|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
639524|NCT02366338|P3|Participant Flow|Group 3|Patients on dabigatran therapy
636898|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636899|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636900|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636901|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636902|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636903|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636904|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636905|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636906|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636907|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636908|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636909|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636910|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636911|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636912|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636913|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636914|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636915|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636916|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636917|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636918|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636919|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636920|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636921|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636922|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636923|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636924|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636925|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636926|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636927|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636928|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636929|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636930|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636931|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636932|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636933|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636934|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636935|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636936|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636937|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636938|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
639525|NCT02366338|P2|Participant Flow|Group 2|patients on rivaroxaban therapy
636939|NCT02404493|O2|Outcome|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636940|NCT02404493|O1|Outcome|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636941|NCT02404493|E2|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram skin barrier emulsion applied in a thin layer to affected skin areas two times per day or as needed
636942|NCT02404493|E1|Reported Event|1% Colloidal Oatmeal Balm|1% colloidal oatmeal balm applied in a thin layer to affected skin areas at least once at night or more if needed
636943|NCT02403830|B1|Baseline|Whole Study Population|Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm.
636944|NCT02403830|P2|Participant Flow|Placebo First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received placebo at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (methylnaltrexone).~Placebo: Placebo will be administered as a 0.9% sodium chloride iv injection~Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine~Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
636945|NCT02403830|P1|Participant Flow|Methylnaltrexone First|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. In this arm patients received methylnaltrexone at visit 1. After a 7 ± 2 days wash-out period, patients crossed-over to the alternate study-treatment arm (placebo).~Methylnaltrexone: Methylnaltrexone will be administered diluted with 5 ml of normal saline as a single iv bolus~Morphine: After methylnaltrexone, patients will receive 5-mg intravenous morphine~Ticagrelor: After morphine administration, patients will receive a 180-mg ticagrelor loading dose"
636946|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
636947|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
636948|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
636949|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
636950|NCT02403830|O2|Outcome|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
636951|NCT02403830|O1|Outcome|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
637029|NCT02402127|B3|Baseline|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
636952|NCT02403830|E2|Reported Event|Placebo|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
636953|NCT02403830|E1|Reported Event|Methylnaltrexone|"Patients were randomly assigned in a 1:1 fashion to receive either i.v methylnaltrexone or placebo (0.9% sodium chloride iv injection). Methylnaltrexone, at a dose of 0.3 mg/Kg, was administered diluted with 5 ml of normal saline as a single i.v. bolus over 1 minute followed by morphine (5-mg intravenous bolus). Then patients received iv morphine and a loading dose of ticagrelor. After a 7±2 days wash-out patients received the alternate treatment.~Treatment effects were evaluated comparing the functional parameters observed in the overall patient population after methylnaltrexone therapy with those achieved after placebo therapy regardless of the sequence in which patients received treatment."
636954|NCT02403180|B3|Baseline|Total|Total of all reporting groups
636955|NCT02403180|B2|Baseline|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2.
636956|NCT02403180|B1|Baseline|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2.
636957|NCT02403180|P2|Participant Flow|PROCLEAR 1D MF, Then DACP MF|Omafilcon A contact lenses were worn in Period 1, followed by nelfilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
636958|NCT02403180|P1|Participant Flow|DACP MF, Then PROCLEAR 1D MF|Nelfilcon A contact lenses were worn in Period 1, followed by omafilcon A contact lenses in Period 2. Both products were worn bilaterally (in both eyes) for 5 ±1 days in a daily wear, daily disposable modality.
636959|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
636960|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
636961|NCT02403180|O2|Outcome|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
636962|NCT02403180|O1|Outcome|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
636963|NCT02403180|E2|Reported Event|DACP MF|Nelfilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
636964|NCT02403180|E1|Reported Event|Proclear 1 Day MF|Omafilcon A contact lenses were worn for 5 days in Period 1 or Period 2.
636965|NCT02402764|B1|Baseline|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636966|NCT02402764|P1|Participant Flow|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636967|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636968|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636969|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636970|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636971|NCT02402764|O1|Outcome|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636972|NCT02402764|E1|Reported Event|Selinexor Treatment|Ten patients were treated with oral selinexor 60 mg twice per week (on days 1 and 3) on a schedule of 3 weeks on and 1 week off, each four-week cycle.
636973|NCT02402322|B4|Baseline|Total|Total of all reporting groups
636974|NCT02402322|B3|Baseline|Waiting List|Participants in a waiting list.
636975|NCT02402322|B2|Baseline|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
636976|NCT02402322|B1|Baseline|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636977|NCT02402322|P3|Participant Flow|Waiting List|Participants in a waiting list.
636978|NCT02402322|P2|Participant Flow|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
636979|NCT02402322|P1|Participant Flow|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636980|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
636981|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
637030|NCT02402127|B2|Baseline|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
636982|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636983|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
636984|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
636985|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636986|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
636987|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
636988|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636989|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
636990|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
636991|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636992|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
636993|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
636994|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636995|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
636996|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
636997|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
636998|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
636999|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
637000|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
637001|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
637002|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
637003|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
637004|NCT02402322|O3|Outcome|Waiting List|Participants in a waiting list.
637005|NCT02402322|O2|Outcome|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
637006|NCT02402322|O1|Outcome|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
637007|NCT02402322|E3|Reported Event|Waiting List|Participants in a waiting list.
637031|NCT02402127|B1|Baseline|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
637008|NCT02402322|E2|Reported Event|Scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone weekly.~Scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly."
637009|NCT02402322|E1|Reported Event|Non-scheduled Support|"Participants received an Web-based cognitive behavioral treatment for Panic Disorder with the support of a therapist via phone when they required it.~Non-scheduled support: Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it."
637010|NCT02402296|B3|Baseline|Total|Total of all reporting groups
637011|NCT02402296|B2|Baseline|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
637012|NCT02402296|B1|Baseline|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
637013|NCT02402296|P2|Participant Flow|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
637014|NCT02402296|P1|Participant Flow|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
637015|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
637016|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
637017|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
637018|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
637019|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
637020|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
637021|NCT02402296|O2|Outcome|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
637022|NCT02402296|O1|Outcome|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
637023|NCT02402296|E2|Reported Event|Group II (Test Group)|"Included those patients who received a systemic β-1,3/1,6-D-glucan (100 mg capsule) once/ day for 40 days after scaling and root planing.~β-1,3/1,6-D-glucan: 15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days."
637024|NCT02402296|E1|Reported Event|Group I (Control Group)|"Was assigned for patients who had scaling and root planing and empty capsules filled with carbohydrates (placebo) for 40 days.~Placebo: 15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days."
637025|NCT02402127|B7|Baseline|Total|Total of all reporting groups
637026|NCT02402127|B6|Baseline|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
637027|NCT02402127|B5|Baseline|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
637028|NCT02402127|B4|Baseline|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
637032|NCT02402127|P6|Participant Flow|Clariti 1day, MyDay, TruEye|Somofilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
637033|NCT02402127|P5|Participant Flow|Clariti 1day, TruEye, MyDay|Somofilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
637034|NCT02402127|P4|Participant Flow|MyDay, Clariti 1day, TruEye|Stenfilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and narafilcon A contact lenses in Period 3
637035|NCT02402127|P3|Participant Flow|MyDay, TruEye, Clariti 1day|Stenfilcon A contact lenses in Period 1, followed by narafilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
637036|NCT02402127|P2|Participant Flow|TruEye, Clariti 1day, MyDay|Narafilcon A contact lenses in Period 1, followed by somofilcon A contact lenses in Period 2 and stenfilcon A contact lenses in Period 3
637037|NCT02402127|P1|Participant Flow|TruEye, MyDay, Clariti 1day|Narafilcon A contact lenses in Period 1, followed by stenfilcon A contact lenses in Period 2 and somofilcon A contact lenses in Period 3
637038|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses
637039|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses
637040|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses
637041|NCT02402127|O3|Outcome|Clariti 1day|Somofilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
637042|NCT02402127|O2|Outcome|MyDay|Stenfilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
637043|NCT02402127|O1|Outcome|TruEye|Narafilcon A contact lenses worn for 16 hours in Period 1, Period 2, or Period 3
637044|NCT02402127|E3|Reported Event|Clariti 1day|Somofilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
637045|NCT02402127|E2|Reported Event|MyDay|Stenfilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
637046|NCT02402127|E1|Reported Event|TruEye|Narafilcon A contact lenses worn bilaterally for 1 day (16 hours) in Period 1, Period 2, or Period 3
637047|NCT02401555|B4|Baseline|Total|Total of all reporting groups
637048|NCT02401555|B3|Baseline|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637049|NCT02401555|B2|Baseline|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637050|NCT02401555|B1|Baseline|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637051|NCT02401555|P3|Participant Flow|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637052|NCT02401555|P2|Participant Flow|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637053|NCT02401555|P1|Participant Flow|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637054|NCT02401555|O3|Outcome|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637055|NCT02401555|O2|Outcome|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637056|NCT02401555|O1|Outcome|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637057|NCT02401555|E3|Reported Event|Low Risk (Negatives)|"Individuals at low risk for HIV infection tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637058|NCT02401555|E2|Reported Event|Known AIDS|"Individuals known to meet diagnostic criteria for AIDS tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637059|NCT02401555|E1|Reported Event|Known HIV1 Positives|"Individuals known to the HIV1 positive tested with Geenius HIV1/2 Supplemental Assay~Geenius HIV1/2 Supplemental Assay: The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate)."
637060|NCT02401529|B3|Baseline|Total|Total of all reporting groups
637061|NCT02401529|B2|Baseline|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637062|NCT02401529|B1|Baseline|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637063|NCT02401529|P2|Participant Flow|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637064|NCT02401529|P1|Participant Flow|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637065|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637066|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637067|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637068|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637069|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637070|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~Number of participants when started 59"
637071|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637072|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637073|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637074|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637075|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637076|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637077|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637078|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637079|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637080|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637081|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637082|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637083|NCT02401529|O2|Outcome|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
640284|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
637084|NCT02401529|O1|Outcome|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637085|NCT02401529|E2|Reported Event|Placebo|"Placebo (IV saline) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours~IV saline: IV saline"
637086|NCT02401529|E1|Reported Event|IV Dexamethasone and Oral Prednisolone|"Single dose of intravenous dexamethasone given immediately following surgery (0.15 mg/kg), followed by oral Prednisolone (0.25mg/kg/day for 7 days then tapering for next 7 days) and paracetamol (acetaminophen 15 mg/kg/dose every 6 hours).~IV dexamethasone: 0.15 mg/kg~Oral prednisolone: 0.25mg/kg/day for 7 days then tapering for next 7 days~Paracetamol: acetaminophen 15 mg/kg/dose every 6 hours"
637087|NCT02401464|B5|Baseline|Total|Total of all reporting groups
637088|NCT02401464|B4|Baseline|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637089|NCT02401464|B3|Baseline|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637090|NCT02401464|B2|Baseline|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637091|NCT02401464|B1|Baseline|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637092|NCT02401464|P4|Participant Flow|Granule Cohort: TAK-536 Tablet + TAK-536 Granules|Participants in Sequence b of granules formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days) followed by washout period of at least 6 days, further followed by TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637093|NCT02401464|P3|Participant Flow|Granule Cohort: TAK-536 Granules + TAK-536 Tablet|Participants in Sequence a of granules formulation received TAK-536 10 mg, granules (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637094|NCT02401464|P2|Participant Flow|Dry Syrup Cohort: TAK-536 Tablet + TAK-536 Dry Syrup|Participants in Sequence b of dry syrup formulation received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637095|NCT02401464|P1|Participant Flow|Dry Syrup Cohort: TAK-536 Dry Syrup + TAK-536 Tablet|Participants in Sequence a of dry syrup formulation received TAK-536 10 milligram (mg), dry syrup (pediatric formulation), orally, once on Day 1 of Intervention Period 1 (6 days), followed by washout period of at least 6 days, further followed by TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 2 (6 days).
637096|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637097|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637098|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637099|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
637100|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637101|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637102|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637103|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
637104|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637105|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637106|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637107|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
639526|NCT02366338|P1|Participant Flow|Group 1|patients on warfarin therapy
637108|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637109|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637110|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637111|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
637112|NCT02401464|O4|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637113|NCT02401464|O3|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637114|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637115|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
637116|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637117|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637118|NCT02401464|O2|Outcome|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637119|NCT02401464|O1|Outcome|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637120|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637121|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
637122|NCT02401464|O2|Outcome|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637123|NCT02401464|O1|Outcome|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
637124|NCT02401464|E4|Reported Event|Granule Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637125|NCT02401464|E3|Reported Event|Granule Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, granule (pediatric formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637126|NCT02401464|E2|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Commercial Formulation|Participants received TAK-536 10 mg, tablet (commercial formulation), orally, once on Day 1 of Intervention Period 1 or 2 (6 days).
637127|NCT02401464|E1|Reported Event|Dry Syrup Cohort: TAK-536 10 mg Pediatric Formulation|Participants received TAK-536 10 mg, dry syrup (pediatric formulation), orally, once on Day 1 of either Intervention Period 1 or 2 (6 days).
637128|NCT02400996|B1|Baseline|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
637129|NCT02400996|P1|Participant Flow|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
637130|NCT02400996|O1|Outcome|Patients Operated for Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
637131|NCT02400996|E1|Reported Event|Pancreatic Endocrine Neoplasms|We did an observational analysis from a prospectively maintained database of patients who underwent pancreatic surgery for neoplasms of the pancreas at Sir Ganga Ram Hospital, New Delhi, India from 1995 to 2013 and using pathological reports and preoperative CT scan as gold standard, we identified 40 patients with PENs.
637132|NCT02400710|B3|Baseline|Total|Total of all reporting groups
637133|NCT02400710|B2|Baseline|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
637134|NCT02400710|B1|Baseline|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
637135|NCT02400710|P2|Participant Flow|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
637168|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637136|NCT02400710|P1|Participant Flow|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
637137|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
637138|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
637139|NCT02400710|O2|Outcome|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
637140|NCT02400710|O1|Outcome|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
637141|NCT02400710|E2|Reported Event|Self-Managed PTSD Coach|"One in-person 10-minute session that provides instructions on how to use the PTSD Coach app.~Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app."
637142|NCT02400710|E1|Reported Event|Clinician-Supported PTSD Coach|"Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own.~Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care."
637143|NCT02400333|B5|Baseline|Total|Total of all reporting groups
637144|NCT02400333|B4|Baseline|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
637145|NCT02400333|B3|Baseline|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
637146|NCT02400333|B2|Baseline|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
637147|NCT02400333|B1|Baseline|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
637148|NCT02400333|P4|Participant Flow|DCAB Sequence|Treatment D in Period 1, Treatment C in Period 2, Treatment A in Period 3 and Treatment B in Period 4.
637149|NCT02400333|P3|Participant Flow|CBDA Sequence|Treatment C in Period 1, Treatment B in Period 2, Treatment D in Period 3 and Treatment A in Period 4.
637150|NCT02400333|P2|Participant Flow|BACD Sequence|Treatment B in Period 1, Treatment A in Period 2, Treatment C in Period 3 and Treatment D in Period 4.
637151|NCT02400333|P1|Participant Flow|ADBC Sequence|Treatment A in Period 1, Treatment D in Period 2, Treatment B in Period 3 and Treatment C in Period 4.
637152|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637153|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637154|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637155|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637156|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637157|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637158|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637159|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637160|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637161|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637162|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637163|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637164|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637165|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637166|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637167|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637169|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637170|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637171|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637172|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637173|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637174|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637175|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637176|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637177|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637178|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637179|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637180|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637181|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637182|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637183|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637184|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637185|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637186|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637187|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637188|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637189|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637190|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637191|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637192|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637193|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637194|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637195|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637196|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637197|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637198|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637199|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637200|NCT02400333|O4|Outcome|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637201|NCT02400333|O3|Outcome|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a nasogastric tube (NG) tube into the stomach (total of 200 mL of water).
637202|NCT02400333|O2|Outcome|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637203|NCT02400333|O1|Outcome|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637204|NCT02400333|E4|Reported Event|Treatment D|Participants received Ticagrelor IR tablets administered orally with 200 mL of water.
637205|NCT02400333|E3|Reported Event|Treatment C|Participants received Ticagrelor OD tablets suspended in water to be administered through a NG tube into the stomach (total of 200 mL of water).
637206|NCT02400333|E2|Reported Event|Treatment B|Participants received Ticagrelor OD tablets administered without water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with saliva.
637207|NCT02400333|E1|Reported Event|Treatment A|Participants received Ticagrelor OD tablets administered with water. The OD tablet was placed on the tongue to disintegrate and be swallowed subsequently with 200 mL noncarbonated water at room temperature.
637208|NCT02399345|B1|Baseline|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
637209|NCT02399345|P1|Participant Flow|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
637210|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
637211|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
637212|NCT02399345|O1|Outcome|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
637213|NCT02399345|E1|Reported Event|Ombitasvir/Paritaprevir/r, Dasabuvir, and SOF Plus RBV|Ombitasvir/paritaprevir/ritonavir (ombitasvir/paritaprevir/r) (25 mg/150 mg/100 mg once daily) with dasabuvir (250 mg twice daily) and sofosbuvir (SOF) (400 mg once daily), plus weight-based ribavirin (RBV) (dosed 1,000 or 1,200 mg daily divided twice a day) for 6 weeks.
637214|NCT02399163|B1|Baseline|Overall Participants|All randomized participants were evaluated for baseline characteristics
637215|NCT02399163|P1|Participant Flow|Overall Study|"In this cross-over study, participants were randomized to receive each of following treatments:~Fluoride dentifrice/Fluoride rinse~Placebo dentifrice/Fluoride rinse~Fluoride dentifrice/No rinse~Placebo dentifrice/No rinse"
637216|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
637217|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
637218|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
637219|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
637220|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
637221|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
637222|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
637223|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
637224|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
637225|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
637226|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
637227|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
637228|NCT02399163|O4|Outcome|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
637229|NCT02399163|O3|Outcome|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
637230|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
637231|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
637232|NCT02399163|O2|Outcome|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
637233|NCT02399163|O1|Outcome|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 parts per million (ppm) of fluoride as sodium fluoride
637273|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637234|NCT02399163|E4|Reported Event|Fluoride Dentifrice/Fluoride Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride, followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride.
637235|NCT02399163|E3|Reported Event|Fluoride Dentifrice/No Rinse|Twice daily brushing with a fluoride toothpaste containing 1150 ppm of fluoride as sodium fluoride
637236|NCT02399163|E2|Reported Event|Placebo Dentifrice/No Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste
637237|NCT02399163|E1|Reported Event|Placebo Dentifrice/Fluoride Rinse|Twice daily brushing with a non-fluoride (placebo) toothpaste followed by once daily rinsing (post night time brushing) with a fluoride mouthwash containing 220 ppm of fluoride as sodium fluoride
637238|NCT02399111|B5|Baseline|Total|Total of all reporting groups
637239|NCT02399111|B4|Baseline|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637240|NCT02399111|B3|Baseline|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637241|NCT02399111|B2|Baseline|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
637242|NCT02399111|B1|Baseline|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
637243|NCT02399111|P4|Participant Flow|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637244|NCT02399111|P3|Participant Flow|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637245|NCT02399111|P2|Participant Flow|Obese:BMI≥30; Standard Care|Obese: BMI ≥30; Standard Wound Care
637246|NCT02399111|P1|Participant Flow|Not Obese:BMI<30; Standard Care|Not obese: BMI< 30; Standard Wound Care
637247|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637248|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637249|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Standard Wound Care
637250|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Standard Wound Care
637274|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637275|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637276|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637251|NCT02399111|O4|Outcome|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637252|NCT02399111|O3|Outcome|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637253|NCT02399111|O2|Outcome|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
637254|NCT02399111|O1|Outcome|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
637255|NCT02399111|E4|Reported Event|Obese:BMI≥30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637256|NCT02399111|E3|Reported Event|Not Obese:BMI<30; Wound Vac|"Using Prevena Incision Management System~Prevena Incision Management System: The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period."
637257|NCT02399111|E2|Reported Event|Obese:BMI≥30; Standard Care|Obese:BMI≥30;Standard Wound Care
637258|NCT02399111|E1|Reported Event|Not Obese:BMI<30; Standard Care|Not obese:BMI<30;Standard Wound Care
637259|NCT02397915|B1|Baseline|FF 110 µg /MF 200 µg or MF 200 µg /FF 110 µg|All participants received treatments in one of two treatment sequences, Sequence 1: two sprays of FF (total of 110 µg) in each nostril (total 4 sprays) in Period 1 and two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) in Period 2; Sequence 2: FF (110 µg) followed by MF (total of 200 µg) and MF (total of 200 µg) followed by FF (110 µg) in Period 2. Two study treatments were administered 30 minutes (+/-5) apart by a third party administrator using a metered nasal spray.
637260|NCT02397915|P4|Participant Flow|Period 2: FF 110 µg|Participants received FF (total dose of 110 µg) in each nostril (total 4 sprays).
637261|NCT02397915|P3|Participant Flow|Period 2: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays).
637262|NCT02397915|P2|Participant Flow|Period 1: MF 200 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
637263|NCT02397915|P1|Participant Flow|Period 1: FF 110 µg|Participants received two sprays of FF (total dose of 110 micrograms [µg]) in each nostril (total 4 sprays). Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
637264|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637265|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637266|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637267|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637268|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637269|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637270|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637271|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637272|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637422|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637277|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637278|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637279|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637280|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637281|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637282|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637283|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637284|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637285|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637286|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637287|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637288|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637289|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637290|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637291|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637292|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637293|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637294|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637295|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637296|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637297|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637298|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637299|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637300|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637301|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637302|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637303|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637304|NCT02397915|O2|Outcome|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637305|NCT02397915|O1|Outcome|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637306|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
637307|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
637308|NCT02397915|O2|Outcome|MF 200 µg /FF 110 µg|Participants received two sprays of MF (total dose of 200 µg) in each notstril (total 4 sprays) in Period 1 followed by two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
637336|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637309|NCT02397915|O1|Outcome|FF 110 µg /MF 200 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) in Period 1 followed by two sprays of MF (total dose of 200 µg) in each nostril (total 4 sprays) in Period 2. Two study treatments were administered 30 minutes (+/- 5) apart by a third party administrator using a metered nasal spray.
637310|NCT02397915|E2|Reported Event|MF 200 µg|Participants received two sprays of MF (total of 200 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637311|NCT02397915|E1|Reported Event|FF 110 µg|Participants received two sprays of FF (total dose of 110 µg) in each nostril (total 4 sprays) by the third party administrator using metered nasal spray.
637312|NCT02397655|B1|Baseline|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
637313|NCT02397655|P1|Participant Flow|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
637314|NCT02397655|O1|Outcome|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
637315|NCT02397655|E1|Reported Event|Overall Study|This cross sectional study was totally enrolled 12012 cases. After excluded 1301 cases whose basic clinical information and/or ultrasound examination data not completed, a total of 10711 cases were entered into the final statistical analysis.
637316|NCT02396537|B3|Baseline|Total|Total of all reporting groups
637317|NCT02396537|B2|Baseline|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
637318|NCT02396537|B1|Baseline|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
637319|NCT02396537|P2|Participant Flow|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
637320|NCT02396537|P1|Participant Flow|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
637321|NCT02396537|O2|Outcome|Intranasal 0.9% Saline|Subjects were administered 0.9% saline, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (placebo group).
637322|NCT02396537|O1|Outcome|Intranasal Lidocaine|Subjects were administered 4% lidocaine solution, 0.5 ml in each naris, 5 minutes prior to intranasal midazolam (intervention group).
637323|NCT02396537|E2|Reported Event|Intranasal 0.9% Saline|"Patient to receive 0.9% Saline intranasally prior to midazolam~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.~0.9% Saline: Administered intranasally prior to Midazolam administration."
637324|NCT02396537|E1|Reported Event|Intranasal Lidocaine|"Patient to receive 4% lidocaine intranasally prior to midazolam~Lidocaine: Administered intranasally prior to Midazolam administration.~Midazolam: Administered to all patients immediately after study drug (Lidocaine or Placebo) administered."
637325|NCT02396160|B3|Baseline|Total|Total of all reporting groups
637326|NCT02396160|B2|Baseline|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637327|NCT02396160|B1|Baseline|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637328|NCT02396160|P2|Participant Flow|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637329|NCT02396160|P1|Participant Flow|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637330|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637331|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637332|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637333|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637334|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637335|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637337|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637338|NCT02396160|O2|Outcome|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637339|NCT02396160|O1|Outcome|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637340|NCT02396160|E2|Reported Event|Placebo|"identical placebo vegetarian capsule containing color-matched cellulose~Placebo: Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment"
637341|NCT02396160|E1|Reported Event|Treatment|"2 capsules per day of the herbal formula (Urox®) with each capsule containing 420mg of a concentrated proprietary blend of extracts of Crateva nurvala stem bark, Equisetum arvense stem and Lindera aggregata root~Urox: Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs"
637342|NCT02396147|B3|Baseline|Total|Total of all reporting groups
637343|NCT02396147|B2|Baseline|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
637344|NCT02396147|B1|Baseline|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
637345|NCT02396147|P2|Participant Flow|Arm 2: T2-A + T4C-D + T4C-E|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was 10-day washout period between each dose.
637346|NCT02396147|P1|Participant Flow|Arm 1: T2-A + T4B-B + T4B-C|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, and T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions. There were 6 randomized sequences. Study medication was administered as a single dose on Days 1, 11 and 21. There was a 10-day washout period between each dose.
637347|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637348|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637349|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637350|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637351|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637352|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637353|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637354|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637355|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637356|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637357|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637358|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637359|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637360|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637361|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637362|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637363|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637364|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637365|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637366|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637367|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637368|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637369|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637370|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637371|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637372|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637373|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637374|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637375|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637376|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637377|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637378|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637379|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637380|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637381|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637382|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637383|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637384|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637385|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637386|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637387|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637388|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637389|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637390|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637391|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637392|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637393|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637394|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637395|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637396|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637397|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637398|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637399|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637400|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637401|NCT02396147|O6|Outcome|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637402|NCT02396147|O5|Outcome|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637403|NCT02396147|O4|Outcome|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637404|NCT02396147|O3|Outcome|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637405|NCT02396147|O2|Outcome|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637406|NCT02396147|O1|Outcome|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637407|NCT02396147|E6|Reported Event|Arm 2: T4 Formulation C Fed|T4 Formulation C Regimen E (T4C-E) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637408|NCT02396147|E5|Reported Event|Arm 2: T4 Formulation C Fasted|T4 Formulation C Regimen D (T4C-D) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637409|NCT02396147|E4|Reported Event|Arm 2: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637410|NCT02396147|E3|Reported Event|Arm 1: T4 Formulation B Fed|T4 Formulation B Regimen C (T4B-C) TAK-385, 120 mg tablet, orally, under fed conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637411|NCT02396147|E2|Reported Event|Arm 1: T4 Formulation B Fasted|T4 Formulation B Regimen B (T4B-B) TAK-385, 120 mg tablet, orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637412|NCT02396147|E1|Reported Event|Arm 1: T2 Formulation Fasted|T2 Formulation Regimen A (T2-A) TAK-385, 120 mg tablet (80 mg + 40 mg tablets), orally, under fasted conditions, once on the first day of one of the 3 treatment periods (Day 1, Day 11 or Day 21).
637413|NCT02395302|B1|Baseline|Dual Action Pneumatic Compression|"Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.~Dual Action Pneumatic Compression: Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period."
637414|NCT02395302|P1|Participant Flow|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an alternating current (AC) outlet. Subjects that received the dual action pneumatic compression device were instructed to use the device in sustained mode for fourteen hours per day and in intermittent mode for three hours per day during the four week treatment period.
637415|NCT02395302|O1|Outcome|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
637416|NCT02395302|E1|Reported Event|Dual Action Pneumatic Compression|Dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
637417|NCT02395055|B3|Baseline|Total|Total of all reporting groups
637418|NCT02395055|B2|Baseline|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637419|NCT02395055|B1|Baseline|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637420|NCT02395055|P2|Participant Flow|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637421|NCT02395055|P1|Participant Flow|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637423|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637424|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637425|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637426|NCT02395055|O2|Outcome|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637427|NCT02395055|O1|Outcome|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637428|NCT02395055|E2|Reported Event|Humira Group|Humira (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637429|NCT02395055|E1|Reported Event|BCD-057 Group|BCD-057 (adalimumab) at a dose of 40 mg, administered as a single subcutaneous injection, which will be performed on week 0.
637430|NCT02394925|B1|Baseline|Dispensed Subjects|All subjects in that were dispensed the study lens.
637431|NCT02394925|P1|Participant Flow|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
637432|NCT02394925|O1|Outcome|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
637433|NCT02394925|E1|Reported Event|Etafilcon -PVP (Multi-focal)|All subjects in the study wore the test lens etafilcon- PVP (Multi-focal) throughout the entire duration of the study.
637434|NCT02394756|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least 1 study lens.
637435|NCT02394756|P6|Participant Flow|Comfilcon A/Lotrafilcon B/Senofilcon A|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the lotrafilcon B lens in the second period and the senofilcon A lens in the third period.
637436|NCT02394756|P5|Participant Flow|Comfilcon A/Senofilcon A/ Lotrafilcon B|Subjects randomized to this sequence wore the comfilcon A lens in the first period, the senofilcon A lens in the second period and the lotrafilcon B lens in the third period.
637437|NCT02394756|P4|Participant Flow|Lotrafilcon B/Senofilcon A/Comfilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the senofilcon A lens in the second period and the comfilcon A lens in the third period.
637438|NCT02394756|P3|Participant Flow|Lotrafilcon B/Comfilcon A/Senofilcon A|Subjects randomized to this sequence wore the lotrafilcon B lens in the first period, the comfilcon A lens in the second period and the senofilcon A lens in the third period.
637439|NCT02394756|P2|Participant Flow|Senfilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the comfilcon A lens in the second period and the lotrafilcon B lens in the third period.
637440|NCT02394756|P1|Participant Flow|Senofilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence wore the senofilcon A lens in the first period, the lotrafilcon B lens in the second period and the comfilcon A lens in the third period.
637441|NCT02394756|O3|Outcome|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
637442|NCT02394756|O2|Outcome|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
637443|NCT02394756|O1|Outcome|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
637444|NCT02394756|O3|Outcome|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
637445|NCT02394756|O2|Outcome|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
637446|NCT02394756|O1|Outcome|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
637447|NCT02394756|E3|Reported Event|Comfilcon A|Subjects wore the comfilcon A lens in any of the three periods during the study.
637448|NCT02394756|E2|Reported Event|Lotrafilcon B|Subjects wore the lotrafilcon B lens in any of the three periods during the study.
637449|NCT02394756|E1|Reported Event|Senofilcon A|Subjects wore the senofilcon A lens in any of the three periods during the study.
637450|NCT02394665|B4|Baseline|Total|Total of all reporting groups
637451|NCT02394665|B3|Baseline|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637452|NCT02394665|B2|Baseline|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637453|NCT02394665|B1|Baseline|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637454|NCT02394665|P3|Participant Flow|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637455|NCT02394665|P2|Participant Flow|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637456|NCT02394665|P1|Participant Flow|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637457|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637458|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637459|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637460|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637461|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637462|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637463|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637464|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637465|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637466|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637467|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637468|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637469|NCT02394665|O3|Outcome|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637470|NCT02394665|O2|Outcome|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637471|NCT02394665|O1|Outcome|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637472|NCT02394665|E3|Reported Event|Group 2: SRS Boost + IMRT|"For patients with High-Risk Tumor Volumes (HTV) <= 4cm; or multiple HTVs <= 3 cm:~Stereotactic Radiosurgery Boost (SRS Boost) followed one week later by Fractionated Intensity Modulated Radiation therapy (IMRT), and concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637473|NCT02394665|E2|Reported Event|Group 1: SIB + IMRT|"Simultaneous Integrated Boost (SIB) plus Fractionated Intensity Modulated Radiation therapy (IMRT), with concurrent Temozolomide therapy for 6 weeks;~3D MRSI during week 3, end of RT and other protocol-defined time points during adjuvant Temozolomide therapy;~Functional Assessment of Cancer Therapy-Brain (FACT-Br) questionnaire administered at protocol-defined time points;~Adjuvant Temozolomide Therapy for up to 12 cycles."
637474|NCT02394665|E1|Reported Event|No Treatment Group Assigned|For subject withdrawn from study prior to assignment of treatment group. No protocol therapy received.
637475|NCT02394457|B3|Baseline|Total|Total of all reporting groups
639527|NCT02366338|O3|Outcome|Group 3|Patients on dabigatran therapy
637476|NCT02394457|B2|Baseline|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637477|NCT02394457|B1|Baseline|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637478|NCT02394457|P2|Participant Flow|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637479|NCT02394457|P1|Participant Flow|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637480|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637481|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637482|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637483|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637484|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637485|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637486|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637487|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637488|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637489|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637490|NCT02394457|O2|Outcome|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637491|NCT02394457|O1|Outcome|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637492|NCT02394457|E2|Reported Event|Epidural Blood Patch Group B|"Epidural Blood Patch and I000cc Normal Saline~Epidural Blood Patch: Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel."
637493|NCT02394457|E1|Reported Event|Intravenous Cosyntropin Group A|"Cosyntropin 500 mcg in 1000cc Normal Saline~Cosyntropin: Intravenous Drug Infusion over 1 hour and a half"
637494|NCT02393950|B3|Baseline|Total|Total of all reporting groups
637495|NCT02393950|B2|Baseline|Panel 2|Single oral doses ODM-106 Capsule B 100, 100, 200 mg. ODM-106 Capsule A 100mg, placebo
637496|NCT02393950|B1|Baseline|Panel 1|Single oral doses ODM-106 Capsule B 2, 10, 25, 50mg, placebo
637497|NCT02393950|P2|Participant Flow|Panel 2|Single oral doses ODM-106 Capsule B: 100, 100, 200mg. ODM-106 Capsule A 100 mg , placebo
637498|NCT02393950|P1|Participant Flow|Panel 1|Single oral doses ODM-106 Capsule B: 2, 10, 25, 50 mg , placebo
637499|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
637500|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
637501|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
637502|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
637503|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
637504|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
637505|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
637506|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
637507|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
637508|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
637509|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
637510|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B.
637511|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
637512|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B.
637513|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B.
637514|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B.
637515|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B.
637516|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B.
637517|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
637518|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A.
637519|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
637520|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B.
637521|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
637522|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
637523|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5mg ODM-106 Capsule B
639528|NCT02366338|O2|Outcome|Group 2|patients on rivaroxaban therapy
637530|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
637531|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
637532|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
637533|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
637534|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
637535|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
637536|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
637537|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
637538|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
637539|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
637540|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
637541|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg and 1 x 5 mg ODM-106 Capsule B
637542|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
637543|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
637544|NCT02393950|O9|Outcome|Placebo|2 placebo subjects per Arm with matched number of placebo capsules.
637545|NCT02393950|O8|Outcome|ODM-106 Capsule A 100mg|Single oral dose 10 x 10mg ODM-106 Capsule A
637546|NCT02393950|O7|Outcome|ODM-106 Capsule B 200mg|Single oral dose 20 x 10mg ODM-106 Capsule B
637547|NCT02393950|O6|Outcome|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10mg ODM-106 Capsule B
637548|NCT02393950|O5|Outcome|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100mg ODM-106 Capsule B
637549|NCT02393950|O4|Outcome|ODM-106 Capsule B 50mg|Single oral dose 5 x 10mg ODM-106 Capsule B
637550|NCT02393950|O3|Outcome|ODM-106 Capsule B 25mg|Single oral dose 2 x 10mg 1 x 5 mg ODM-106 Capsule B
637551|NCT02393950|O2|Outcome|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
637552|NCT02393950|O1|Outcome|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
637553|NCT02393950|E9|Reported Event|Placebo|2 placebo subjects per Arm with matched number of placebo capsules
637554|NCT02393950|E8|Reported Event|ODM-106 Capsule A 100mg|Single oral dose 10 x 10 mg ODM-106 Capsule A
637555|NCT02393950|E7|Reported Event|ODM-106 Capsule B 200mg|Single oral dose 20 x 10 mg ODM-106 Capsule B
637556|NCT02393950|E6|Reported Event|ODM-106 Capsule B 100mg (10 x 10mg)|Single oral dose 10 x 10 mg ODM-106 Capsule B
637557|NCT02393950|E5|Reported Event|ODM-106 Capsule B 100mg (1 x 100mg)|Single oral dose 1 x 100 mg ODM-106 Capsule B
637558|NCT02393950|E4|Reported Event|ODM-106 Capsule B 50mg|Single oral dose 5 x 10 mg ODM-106 Capsule B
637559|NCT02393950|E3|Reported Event|ODM-106 Capsule B 25mg|Single oral dose 2 x 10 mg 1 x 5 mg ODM-106 Capsule B
637560|NCT02393950|E2|Reported Event|ODM-106 Capsule B 10mg|Single oral dose 2 x 5 mg ODM-106 Capsule B
637561|NCT02393950|E1|Reported Event|ODM-106 Capsule B 2mg|Single oral dose 2 x 1 mg ODM-106 Capsule B
637562|NCT02393677|B3|Baseline|Total|Total of all reporting groups
637563|NCT02393677|B2|Baseline|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
637564|NCT02393677|B1|Baseline|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
637565|NCT02393677|P2|Participant Flow|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
637566|NCT02393677|P1|Participant Flow|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
637567|NCT02393677|O2|Outcome|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
637568|NCT02393677|O1|Outcome|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
637569|NCT02393677|E2|Reported Event|Ropivacaine With Dexmedetomidine|"combination of amide local anaesthetic and alpha2 agonist~Ropivacaine with Dexmedetomidine: Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus"
637570|NCT02393677|E1|Reported Event|Ropivacaine|"amide local anesthetic~Ropivacaine: Ropivacaine 0.5% 30 ml was used to block brachial plexus"
637571|NCT02393547|B1|Baseline|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
637572|NCT02393547|P1|Participant Flow|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
637573|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
637574|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
637575|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
637576|NCT02393547|O1|Outcome|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
637577|NCT02393547|E1|Reported Event|Varenicline + Lorcaserin|"Open label all subjects receive both Varenicline and Lorcaserin~Varenicline: All subjects receive Varenicline~Lorcaserin: All subjects receive Lorcaserin"
637579|NCT02392767|B2|Baseline|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
637580|NCT02392767|B1|Baseline|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
637581|NCT02392767|P2|Participant Flow|First Placebo, Then Verum|2 times a day 2 placebo tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 verum tablets for 4 weeks.
637582|NCT02392767|P1|Participant Flow|First Verum, Then Placebo|2 times a day 2 verum tablets for 4 weeks. 8 weeks wash out. Then 2 times a day 2 placebo tablets for 4 weeks.
637583|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks~Placebo: corn starch"
637584|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
637585|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
637586|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
637587|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
637588|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
637589|NCT02392767|O2|Outcome|Placebo|2 times 2 tablets a day for 4 weeks. Placebo: corn starch
637590|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
637591|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks~Placebo: corn starch"
637592|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
637593|NCT02392767|O2|Outcome|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
637594|NCT02392767|O1|Outcome|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
637595|NCT02392767|E2|Reported Event|Placebo|"2 times 2 tablets a day for 4 weeks.~Placebo: corn starch"
637596|NCT02392767|E1|Reported Event|Verum|"2 times 2 tablets a day for 4 weeks.~Verum: 2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid."
637597|NCT02392247|B1|Baseline|Cardiac Surgery Patients|Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. Paired blood samples were assessed by thromboelastography (TEG; current care option) and by Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry
637598|NCT02392247|P1|Participant Flow|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
637599|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
637600|NCT02392247|O1|Outcome|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry. Blood was collected at four time points: baseline, during bypass, 10 minutes after heparin reversal just prior to bypass weaning, and off-bypass before transfer to the ICU.~Blood specimen collection"
637601|NCT02392247|E1|Reported Event|Cardiac Surgery Patients|"Single cohort of 50 consecutive cardiac surgery patients undergoing cardiopulmonary bypass. The study compares output of two technologies for determination of point of care coagulation function: thromboelastography (TEG; current care option) and the new technology Sonic Estimation of Elasticity via Resonance (SEER) Sonorheometry~Blood specimen collection"
637602|NCT02392208|B1|Baseline|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637603|NCT02392208|P1|Participant Flow|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637652|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
639529|NCT02366338|O1|Outcome|Group 1|patients on warfarin therapy
637799|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637604|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637605|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637606|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637607|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637608|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637609|NCT02392208|O1|Outcome|All Study Participants|"Period 1: Telavancin Before Hemodialysis Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin (5 mg/kg) administered intravenously (IV) before their normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations.~Period 2: Telavancin After Hemodialysis After a minimum 14-day period, participants from Period 1 receive another dose of telavancin (5 mg/kg). This dose is administered intravenously (IV) after the participant's normally scheduled hemodialysis session. Blood samples are collected over a 48-hour period to assess telavancin plasma concentrations."
637610|NCT02392208|E2|Reported Event|Telavancin After Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin immediately after their normally scheduled hemodialysis session.~Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).~Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
637611|NCT02392208|E1|Reported Event|Telavancin Before Hemodialysis|"Stage 5 Chronic Kidney Disease patients receive a single dose of telavancin before their normally scheduled hemodialysis session.~Telavancin: A single 5 mg/kg dose of telavancin is administered intravenously (IV).~Pharmacokinetic Blood Sampling: Blood samples are collected to assess telavancin plasma concentrations."
637612|NCT02391714|B3|Baseline|Total|Total of all reporting groups
637613|NCT02391714|B2|Baseline|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
637614|NCT02391714|B1|Baseline|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
637653|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637654|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637943|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637615|NCT02391714|P2|Participant Flow|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
637616|NCT02391714|P1|Participant Flow|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
637617|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients"
637618|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
637619|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients"
637620|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Povidone-Iodine: Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.~Chlorhexidine: For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic"
637621|NCT02391714|O2|Outcome|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
637622|NCT02391714|O1|Outcome|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
637623|NCT02391714|E2|Reported Event|Nitrous Oxide (NO)|"Nitrous Oxide in a fixed dose ratio of 50% nitrous/50% oxygen will be administered via disposable scented nasal masks 2 minutes before and throughout the procedure; 100% oxygen will be given after the procedure for 3-5 minutes.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Nitrous oxide: Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask."
637624|NCT02391714|E1|Reported Event|Oxygen (Placebo)|"100% oxygen will be administered via disposable scented nasal masks 2 minutes before, throughout and 3-5 minutes after procedure.~If you are randomized to this group, you will undergo the IUD insertion (including Povidone-Iodine or Chlorhexidine swab) using standard technique.~IUD insertion: The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.~Oxygen: 100% oxygen via nasal mask."
637625|NCT02391311|B3|Baseline|Total|Total of all reporting groups
637626|NCT02391311|B2|Baseline|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637627|NCT02391311|B1|Baseline|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637628|NCT02391311|P2|Participant Flow|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637629|NCT02391311|P1|Participant Flow|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637630|NCT02391311|O2|Outcome|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637631|NCT02391311|O1|Outcome|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637632|NCT02391311|O2|Outcome|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637633|NCT02391311|O1|Outcome|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637634|NCT02391311|E2|Reported Event|Active tDCS + Cognitive Remediation|"Subjects in the active arm will be administered active transcranial direct current stimulation (tDCS) (i.e., 2.0 mA tDCS will be administered for 20 minutes and then will automatically turn off). Active group will have identical intervention engagement in 10 1-hour computerized cognitive remediation therapy sessions during active tDCS as with the sham tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637635|NCT02391311|E1|Reported Event|Sham tDCS + Cognitive Remediation|"Subjects in the sham arm will be administered sham transcranial direct current stimulation (tDCS) (i.e., tDCS will be administered for 30 seconds and then will automatically turn off). Sham group will have identical intervention of engagement in 10 1-hour computerized cognitive remediation therapy sessions during sham tDCS as with the active tDCS condition.~transcranial direct current stimulation (tDCS): tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions."
637636|NCT02391038|B1|Baseline|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637637|NCT02391038|P3|Participant Flow|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637638|NCT02391038|P2|Participant Flow|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637639|NCT02391038|P1|Participant Flow|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637640|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637641|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, injection, intravenously on Day 1 of 3 week cycles of Phase 2, until disease progression or unacceptable toxicity. Dosage for this phase was determined from results of Phase 1 MTD/RP2D.
637642|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637643|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637644|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637645|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637646|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637647|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637648|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637649|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637650|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637651|NCT02391038|O1|Outcome|Phase 2: All Participants|MLN0264, infusion was planned to be administered intravenously on Day 1 of every 3 week cycle for up to 1 year or until disease progression or unacceptable toxicity during Phase 2. Dosage for this phase was to be determined from results of Phase 1 MTD/RP2D.
637798|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637655|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637656|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637657|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637658|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637659|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637660|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637661|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637662|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637663|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637664|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637665|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637666|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637667|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637668|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637669|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637670|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637671|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637672|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637673|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637674|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637675|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637676|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637677|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637678|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637679|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637680|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637681|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637682|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637683|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637936|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637684|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637685|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637686|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637687|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637688|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637689|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637690|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637691|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637692|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637693|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637694|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637695|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637696|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637697|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637698|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637699|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637700|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637701|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637702|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637703|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637704|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637705|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637706|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637707|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637708|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637709|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637710|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637711|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637712|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637937|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637713|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637714|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637715|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637716|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637717|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637718|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637719|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637720|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637721|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637722|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637723|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637724|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637725|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637726|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637727|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637728|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637729|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637730|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637731|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637732|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637733|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637734|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637735|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637736|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637737|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637738|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637739|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637740|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637741|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637938|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637742|NCT02391038|O3|Outcome|Phase 1: MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, infusion, intravenously, over 30 minutes on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637743|NCT02391038|O2|Outcome|Phase 1: MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637744|NCT02391038|O1|Outcome|Phase 1: MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle during the Phase 1, for up to 1 year or until disease progression or unacceptable toxicity
637745|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637746|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637747|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637748|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637749|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637750|NCT02391038|O1|Outcome|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637751|NCT02391038|E1|Reported Event|Phase 1: All Participants|Participants who either received MLN0264 1.2 mg/kg as starting dose, or 1.5 mg/kg, or 1.8 mg/kg infusion, intravenously over 30 minutes, on Day 1 of every 3 week cycle of Phase 1, for up to 1 year or until disease progression or unacceptable toxicity.
637752|NCT02390167|B1|Baseline|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
637753|NCT02390167|P1|Participant Flow|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
637754|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637755|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637756|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637757|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637758|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637759|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637760|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637761|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637762|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637763|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637764|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637765|NCT02390167|O1|Outcome|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637766|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System)."
637767|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
637768|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary palm blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
637769|NCT02390167|O1|Outcome|Persons With Diabetes|"Untrained Subjects WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~ONYX NEXT BGMS: Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
637770|NCT02390167|E1|Reported Event|Persons With and Without Diabetes|"Untrained Subjects WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System).~The ONYX NEXT BGMS: Untrained Persons WITH and WITHOUT Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
637771|NCT02389881|B8|Baseline|Total|Total of all reporting groups
637772|NCT02389881|B7|Baseline|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637773|NCT02389881|B6|Baseline|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
637774|NCT02389881|B5|Baseline|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637775|NCT02389881|B4|Baseline|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637776|NCT02389881|B3|Baseline|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637777|NCT02389881|B2|Baseline|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637778|NCT02389881|B1|Baseline|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637779|NCT02389881|P7|Participant Flow|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637780|NCT02389881|P6|Participant Flow|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
637781|NCT02389881|P5|Participant Flow|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637782|NCT02389881|P4|Participant Flow|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637783|NCT02389881|P3|Participant Flow|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637784|NCT02389881|P2|Participant Flow|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637785|NCT02389881|P1|Participant Flow|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637786|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637787|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637788|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637789|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637790|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637791|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637792|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637793|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637794|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637795|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637796|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637797|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
639530|NCT02366338|E3|Reported Event|Group 3|Patients on dabigatran therapy
637800|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637801|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637802|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637803|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637804|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637805|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637806|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
637807|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637808|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637809|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637810|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637811|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637812|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637813|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
637814|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637815|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637816|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637817|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637818|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637819|NCT02389881|O7|Outcome|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637820|NCT02389881|O6|Outcome|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
637821|NCT02389881|O5|Outcome|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637822|NCT02389881|O4|Outcome|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637823|NCT02389881|O3|Outcome|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637824|NCT02389881|O2|Outcome|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637825|NCT02389881|O1|Outcome|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637826|NCT02389881|E7|Reported Event|Cohort 4 Elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637827|NCT02389881|E6|Reported Event|Cohorts 1, 2, 3 and 5 Non-elderly Healthy: Placebo|TAK-058 placebo-matching solution, orally, once daily on Day 1 and Days 4 through 10 (Cohorts 1, 2 and 3), or TAK-058 placebo-matching solution, orally, once on Day 1 (Cohort 5), in non-elderly healthy participants.
637828|NCT02389881|E5|Reported Event|Cohort 5 Non-elderly Healthy: TAK-058 300 mg|TAK-058 300 mg solution, orally, once on Day 1, in non-elderly healthy participants.
637829|NCT02389881|E4|Reported Event|Cohort 4 Elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in elderly healthy participants.
637830|NCT02389881|E3|Reported Event|Cohort 3 Non-elderly Healthy: TAK-058 150 mg|TAK-058 150 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637831|NCT02389881|E2|Reported Event|Cohort 2 Non-elderly Healthy: TAK-058 75 mg|TAK-058 75 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637832|NCT02389881|E1|Reported Event|Cohort 1 Non-elderly Healthy: TAK-058 25 mg|TAK-058 25 mg solution, orally, once daily on Day 1 and Days 4 through 10, in non-elderly healthy participants.
637833|NCT02389452|B1|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637944|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637834|NCT02389452|P1|Participant Flow|Synvisc-One|Single 6 mL intra-articular (IA) injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52 ) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637835|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637836|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637837|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637838|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637839|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637840|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637841|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637842|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637843|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637844|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637845|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637846|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637847|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637939|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637940|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
639531|NCT02366338|E2|Reported Event|Group 2|patients on rivaroxaban therapy
637848|NCT02389452|O1|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.
637849|NCT02389452|E2|Reported Event|Synvisc-One: Local Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain. Local adverse events were defined as any adverse event which occurred in the treated joint.
637850|NCT02389452|E1|Reported Event|Synvisc-One: Systemic Adverse Event|Single 6 mL IA injection of Synvisc-One at Day 0 (Initial Treatment). Participants received repeat injection based on physician’s discretion of safety and efficacy at Week 26, 39 or 52 (Repeat treatment). Repeat injection was given if there was no major safety concerns and WOMAC A1 subscore (measurement of pain while walking on flat surface) was between 40-80 mm (at Week 26, 39 or 52) when measured on a 0-100 mm scale, where higher score indicate higher pain.Systemic adverse events were defined as any adverse event which occurred anywhere other than in the treated joint.
637851|NCT02389361|B3|Baseline|Total|Total of all reporting groups
637852|NCT02389361|B2|Baseline|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
637853|NCT02389361|B1|Baseline|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
637854|NCT02389361|P2|Participant Flow|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
637855|NCT02389361|P1|Participant Flow|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
637856|NCT02389361|O2|Outcome|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
637857|NCT02389361|O1|Outcome|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
637858|NCT02389361|E2|Reported Event|Group PT|"Postoperative Analgesia with Paracetamol-Tramadol~Paracetamol-Tramadol: Postoperative analgesia with intravenous Paracetamol and Tramadol"
637859|NCT02389361|E1|Reported Event|Group Z|"Postoperative Analgesia with Zaldiar~Zaldiar: Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)"
637860|NCT02389088|B1|Baseline|Phase I|9 PCOS women
637861|NCT02389088|P1|Participant Flow|Phase I - All Study Participants|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
637862|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
637863|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
637864|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
637865|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
637866|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
637867|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
637868|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
637869|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
637870|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
637871|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
637872|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
637873|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
637874|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
637875|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
637876|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
637877|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
637878|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
637879|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
637880|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
637881|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
637882|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
637883|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
637884|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
637885|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
637886|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
637887|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
637888|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
637889|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
637890|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
637891|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
637892|NCT02389088|O10|Outcome|Phase II - Week 6 - 24 Hours|
637893|NCT02389088|O9|Outcome|Phase II - Week 6 - 0 Hours|
637894|NCT02389088|O8|Outcome|Phase II - Week 5 - 24 Hours|
637895|NCT02389088|O7|Outcome|Phase II - Week 5 - 0 Hours|
637896|NCT02389088|O6|Outcome|Phase II - Week 0 - 24 Hours|
637897|NCT02389088|O5|Outcome|Phase I - Week 6 - 24 Hour|
637898|NCT02389088|O4|Outcome|Phase I - Week 6 - 0 Hour|
637899|NCT02389088|O3|Outcome|Phase I - Week 5 - 24 Hour|
637900|NCT02389088|O2|Outcome|Phase I - Week 5 - 0 Hour|
637901|NCT02389088|O1|Outcome|Phase I - Week 0 - 24 Hours|
637941|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637942|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637902|NCT02389088|E2|Reported Event|Phase II|"Women that participated in Phase I will be studied again after a washout of 2 months. On study day one, an FSH stimulation test will be performed as described above.~After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month. Four weeks after administration of Lupron, each subject will receive Letrozole 5mg for 14 days. The FSH stimulation test will be repeated at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function).~Letrozole: In Phase II, letrozole, 5 mg/day, will be given for 14 days"
637903|NCT02389088|E1|Reported Event|Phase I|"9 PCOS women will be studied. On study day one, r-FSH will be administered I.V. at a dose of 150 IU (FSH stimulation test). Blood samples will be obtained before and after FSH administration. After the FSH stimulation test, each subject will receive an I.M. injection of Lupron 3.75 mg. This dose has a duration effect of one month.~The FSH stimulation test will be repeated, as described above, at 5 weeks (early resumption of ovarian function) and 6 weeks (moderate resumption of ovarian function)."
637904|NCT02388815|B1|Baseline|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
637905|NCT02388815|P1|Participant Flow|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
637906|NCT02388815|O1|Outcome|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
637907|NCT02388815|E1|Reported Event|FreeStyle Libre Flash Glucose Monitoring System|"FreeStyle Libre Flash Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
637908|NCT02388763|B1|Baseline|Overall|Habitual contact lenses worn first, followed by stenfilcon A contact lenses and narafilcon A contact lenses in Periods 1 and 2 as randomized. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
637909|NCT02388763|P2|Participant Flow|Habitual, 1DAVTE, MyDay|Habitual contact lenses worn first, followed by narafilcon A contact lenses in Period 1 and stenfilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
637910|NCT02388763|P1|Participant Flow|Habitual, MyDay, 1DAVTE|Habitual contact lenses worn first, followed by stenfilcon A contact lenses in Period 1 and narafilcon A contact lenses in Period 2. Each product worn bilaterally for 10 days in a daily wear, daily disposable modality.
637911|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
637912|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
637913|NCT02388763|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
637914|NCT02388763|O1|Outcome|MyDay|Stenfilcon A contact lenses worn bilaterally for 10 days in a daily wear, daily disposable modality
637915|NCT02388763|E5|Reported Event|1DAVTE|Narafilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
637916|NCT02388763|E4|Reported Event|MyDay|Stenfilcon A contact lenses worn for 10 days during Period 1 or 2 as randomized
637917|NCT02388763|E3|Reported Event|Clariti 1-Day|Somofilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
637918|NCT02388763|E2|Reported Event|Dailies Total 1|Delefilcon A contact lenses per subject's habitual prescription worn for 10 days prior to Period 1
637919|NCT02388763|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
637920|NCT02388347|B6|Baseline|Total|Total of all reporting groups
637921|NCT02388347|B5|Baseline|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637922|NCT02388347|B4|Baseline|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637923|NCT02388347|B3|Baseline|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637924|NCT02388347|B2|Baseline|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637925|NCT02388347|B1|Baseline|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637926|NCT02388347|P5|Participant Flow|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637927|NCT02388347|P4|Participant Flow|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637928|NCT02388347|P3|Participant Flow|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637929|NCT02388347|P2|Participant Flow|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637930|NCT02388347|P1|Participant Flow|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637931|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637932|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637933|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637934|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637935|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637945|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637946|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637947|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637948|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637949|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637950|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637951|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637952|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637953|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637954|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637955|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637956|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637957|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637958|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637959|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637960|NCT02388347|O4|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637961|NCT02388347|O3|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637962|NCT02388347|O2|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637963|NCT02388347|O1|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637964|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637965|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637966|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637967|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637968|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637969|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637970|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637971|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637972|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637973|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637974|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637975|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637976|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637977|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637978|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637979|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637980|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637981|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637982|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637983|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637984|NCT02388347|O5|Outcome|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637985|NCT02388347|O4|Outcome|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637986|NCT02388347|O3|Outcome|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637987|NCT02388347|O2|Outcome|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637988|NCT02388347|O1|Outcome|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
637989|NCT02388347|E5|Reported Event|MEDI7836 Dose 4|Participants received a single-dose of MEDI7836 Dose 4 subcutaneous (SC) injection on Day 1.
637990|NCT02388347|E4|Reported Event|MEDI7836 Dose 3|Participants received a single-dose of MEDI7836 Dose 3 subcutaneous (SC) injection on Day 1.
637991|NCT02388347|E3|Reported Event|MEDI7836 Dose 2|Participants received a single-dose of MEDI7836 Dose 2 subcutaneous (SC) injection on Day 1.
637992|NCT02388347|E2|Reported Event|MEDI7836 Dose 1|Participants received a single-dose of MEDI7836 Dose 1 subcutaneous (SC) injection on Day 1.
637993|NCT02388347|E1|Reported Event|Placebo|Participants received a single-dose of Placebo subcutaneous (SC) injection on Day 1.
638452|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
637994|NCT02388074|B1|Baseline|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
637995|NCT02388074|P1|Participant Flow|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
637996|NCT02388074|O1|Outcome|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
637997|NCT02388074|E1|Reported Event|CyPath® Assay of Deep-Lung Sputum Sample|"Deep-lung sputum was obtained from healthy individuals who had no known lung disease, was labeled with TCPP and evaluated to detect red fluorescent [i.e., cancer] cells (RFCs) from deep-lung sputum samples.~CyPath®: CyPath® diagnostic assay for the early detection of lung cancer using sputum"
637998|NCT02387996|B1|Baseline|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
637999|NCT02387996|P1|Participant Flow|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638000|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638001|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638002|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638003|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638004|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638005|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638006|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638007|NCT02387996|O1|Outcome|Nivolumab 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638008|NCT02387996|E1|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg was administered as a 60 minute IV infusion Q2W
638009|NCT02387801|B3|Baseline|Total|Total of all reporting groups
638010|NCT02387801|B2|Baseline|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638011|NCT02387801|B1|Baseline|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638012|NCT02387801|P2|Participant Flow|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q4W) every 4 weeks through week 44.
638013|NCT02387801|P1|Participant Flow|Ixekizumab Q2W|160 milligrams (mg) ixekizumab given as two subcutaneous (SC) injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once (Q2W) every 2 weeks through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638014|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638015|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638016|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638017|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638018|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638019|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638020|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638021|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638022|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638023|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638024|NCT02387801|O2|Outcome|Ixekizumab Q4W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638025|NCT02387801|O1|Outcome|Ixekizumab Q2W|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638026|NCT02387801|E4|Reported Event|Ixekizumab 80 mg Q4W Post-treatment|All participants receiving at least one dose of ixekizumab entered the post treatment follow-up period for a minimum of 12 weeks.
638027|NCT02387801|E3|Reported Event|Ixekizumab 80 mg Q4W Maintenance|After week 12 all participants are given 80 mg ixekizumab as a single SC injection once Q4W through week 44.
638448|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
638028|NCT02387801|E2|Reported Event|Ixekizumab Q4W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q4W through week 44.
638029|NCT02387801|E1|Reported Event|Ixekizumab Q2W Induction Dosing Period|160 mg ixekizumab given as two SC injections at week 0 followed by 80 mg ixekizumab given as a single SC injection once Q2W through week 12. After week 12 participants will receive 80 mg ixekizumab every 4 weeks through week 44.
638030|NCT02387710|B1|Baseline|All Analyzed Participants|All patients who were randomized, completed both study nights and were included in the analysis
638031|NCT02387710|P2|Participant Flow|Placebo First, Tiagabine Second|Placebo-matching tiagabine administered at normal sleep timeon first study night, then a 1-week non-treatment, then tiagabine 12 mg administered at normal sleep time on second study night
638032|NCT02387710|P1|Participant Flow|Tiagabine First, Placebo Second|Tiagabine 12 mg administered at normal sleep time on first study night, then a 1-week non-treatment period, then placebo-matching tiagabine administered at normal sleep time on second study night.
638033|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or the second study night
638034|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or the second study night
638035|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or second study night
638036|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
638037|NCT02387710|O2|Outcome|Placebo|Placebo administered at sleep time on the first or second study night
638038|NCT02387710|O1|Outcome|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
638039|NCT02387710|E2|Reported Event|Placebo|Placebo administered at sleep time on the first or second study night
638040|NCT02387710|E1|Reported Event|Tiagabine|Tiagabine 12 mg administered at sleep time on the first or second study night
638041|NCT02387580|B7|Baseline|Total|Total of all reporting groups
638042|NCT02387580|B6|Baseline|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
638043|NCT02387580|B5|Baseline|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638044|NCT02387580|B4|Baseline|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638045|NCT02387580|B3|Baseline|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638046|NCT02387580|B2|Baseline|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638047|NCT02387580|B1|Baseline|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638048|NCT02387580|P6|Participant Flow|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638049|NCT02387580|P5|Participant Flow|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638050|NCT02387580|P4|Participant Flow|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638051|NCT02387580|P3|Participant Flow|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638052|NCT02387580|P2|Participant Flow|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638053|NCT02387580|P1|Participant Flow|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638054|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638055|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638056|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638057|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638058|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638059|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638060|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638061|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638062|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638063|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638064|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638065|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
639532|NCT02366338|E1|Reported Event|Group 1|patients on warfarin therapy
638066|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638067|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638068|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638069|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638070|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638071|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638072|NCT02387580|O6|Outcome|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume ) and 960 mg (3 × 320 mg) PQP tablets
638073|NCT02387580|O5|Outcome|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120 mL oral suspension and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638074|NCT02387580|O4|Outcome|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638075|NCT02387580|O3|Outcome|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638076|NCT02387580|O2|Outcome|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638077|NCT02387580|O1|Outcome|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638078|NCT02387580|E6|Reported Event|Regimen F: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638079|NCT02387580|E5|Reported Event|Regimen E: OZ439 Prototype 1 or 3 and PQP - 220mL|800 mg OZ439 Prototype 1 or 3 granules (120mL oral suspension and 100mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638080|NCT02387580|E4|Reported Event|Regimen D: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638081|NCT02387580|E3|Reported Event|Regimen C: OZ439 Prototype 3 and PQP - 110mL|800 mg OZ439 Prototype 3 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638082|NCT02387580|E2|Reported Event|Regimen B: OZ439 Prototype 1 and PQP - 110mL|800 mg OZ439 Prototype 1 granules (oral suspension 60 mL volume and 50 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638083|NCT02387580|E1|Reported Event|Regimen A: OZ439 + TPGS and PQP|800 mg OZ439 + TPGS granules (oral suspension 240 mL volume and 100 mL rinse volume) and 960 mg (3 × 320 mg) PQP tablets
638084|NCT02387554|B5|Baseline|Total|Total of all reporting groups
638085|NCT02387554|B4|Baseline|Sequence 4|Period 1 : ALC Period 2 : A Period 3 : C Period 4 : L
638086|NCT02387554|B3|Baseline|Sequence 3|Period 1 : C Period 2 : ALC Period 3 : L Period 4 : A
638087|NCT02387554|B2|Baseline|Sequence 2|Period 1 : L Period 2 : C Period 3 : A Period 4 : ALC
638088|NCT02387554|B1|Baseline|Sequence 1|Period 1 : A Period 2 : L Period 3 : ALC Period 4 : C
638089|NCT02387554|P4|Participant Flow|Sequence 4|Period 1 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 2 : A (Amlodipine 10mg PO single dose) Period 3 : C (Chlorthalidone 25mg PO single dose) Period 4 : L (Losartan 100mg PO single dose)
638090|NCT02387554|P3|Participant Flow|Sequence 3|Period 1 : C (Chlorthalidone 25mg PO single dose) Period 2 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 3 : L (Losartan 100mg PO single dose) Period 4 : A (Amlodipine 10mg PO single dose)
638091|NCT02387554|P2|Participant Flow|Sequence 2|Period 1 : L (Losartan 100mg PO single dose) Period 2 : C (Chlorthalidone 25mg PO single dose) Period 3 : A (Amlodipine 10mg PO single dose) Period 4 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose)
638092|NCT02387554|P1|Participant Flow|Sequence 1|Period 1 : A (Amlodipine 10mg PO single dose) Period 2 : L (Losartan 100mg PO single dose) Period 3 : ALC (Amlodipine 10mg + Losartan 100mg + Chlorthalidone 25mg PO single dose) Period 4 : C (Chlorthalidone 25mg PO single dose)
638093|NCT02387554|O4|Outcome|EXP3174|EXP3174(losartan active metabolite) ratio in single or combination
638094|NCT02387554|O3|Outcome|HGP1405|HGP1405(chlorthalidone) ratio in single or combination
638095|NCT02387554|O2|Outcome|HGP0608|HGP0608(losartan) ratio in single or combination
638096|NCT02387554|O1|Outcome|HGP0904|HGP0904(amlodipine) ratio in single or combination
638097|NCT02387554|E4|Reported Event|HGP0904+HGP0608+HGP1405|"amlodipine + losartan + chlorthalidone~HGP0904~HGP0608~HGP1405"
638098|NCT02387554|E3|Reported Event|HGP1405|"chlorthalidone~HGP1405"
638099|NCT02387554|E2|Reported Event|HGP0608|"losartan~HGP0608"
638100|NCT02387554|E1|Reported Event|HGP0904|"amlodipine~HGP0904"
638101|NCT02387502|B4|Baseline|Total|Total of all reporting groups
638102|NCT02387502|B3|Baseline|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
638139|NCT02383862|B2|Baseline|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638333|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
638103|NCT02387502|B2|Baseline|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
638104|NCT02387502|B1|Baseline|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
638105|NCT02387502|P3|Participant Flow|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
638106|NCT02387502|P2|Participant Flow|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
638107|NCT02387502|P1|Participant Flow|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
638108|NCT02387502|O3|Outcome|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
638109|NCT02387502|O2|Outcome|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
638110|NCT02387502|O1|Outcome|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
638111|NCT02387502|E3|Reported Event|Intubation With Airtraq Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Airtraq laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Airtraq laryngoscope: In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed."
638112|NCT02387502|E2|Reported Event|Intubation With MacCoy Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with MacCoy laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- MacCoy laryngoscope: In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated."
638334|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
640285|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
638113|NCT02387502|E1|Reported Event|Intubation With Macintosh Laryngoscope|"After randomization, 40 patients were included in this group. After application of rigid neck collar, all patients were intubated with Macintosh laryngoscope. We observed and documented ease of intubation, time of intubation, overall success, number of attempts, Intubation Difficulty Score and POGO score. We also observed hemodynamic response in terms blood pressure and pulse rate. We assessed airway trauma after extubation.~Intubation- Macintosh laryngoscope: Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated."
638114|NCT02387268|B1|Baseline|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
638115|NCT02387268|P1|Participant Flow|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
638116|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
638117|NCT02387268|O1|Outcome|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
638118|NCT02387268|E1|Reported Event|CleanC|"Standard colonoscopy procedure using the CleanC system~CleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure"
638119|NCT02384070|B4|Baseline|Total|Total of all reporting groups
638120|NCT02384070|B3|Baseline|Group 3: Upstream Aspirin Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638121|NCT02384070|B2|Baseline|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638122|NCT02384070|B1|Baseline|Group 1: Upstream Aspirin + Clopidrogel|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
638123|NCT02384070|P3|Participant Flow|Group 3: Upstream Aspirin Plus Bivalirudin|Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
638124|NCT02384070|P2|Participant Flow|Group 2: Upstream Aspirin and Clopidrogel Plus Bivalirudin|Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation
638125|NCT02384070|P1|Participant Flow|Group 1: Upstream Aspirin + Clopidrogel|Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator
638126|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638127|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638128|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
638129|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638130|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638131|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
638132|NCT02384070|O3|Outcome|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638133|NCT02384070|O2|Outcome|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638134|NCT02384070|O1|Outcome|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
638135|NCT02384070|E3|Reported Event|Group 3|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638136|NCT02384070|E2|Reported Event|Group 2|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure~Bivalirudin: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure"
638137|NCT02384070|E1|Reported Event|Group 1|"Aspirin: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure~Clopidogrel: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure"
638138|NCT02383862|B3|Baseline|Total|Total of all reporting groups
638140|NCT02383862|B1|Baseline|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638141|NCT02383862|P2|Participant Flow|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638142|NCT02383862|P1|Participant Flow|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638143|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638144|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638145|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638146|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638147|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638148|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638149|NCT02383862|O2|Outcome|Control Group (EMR)|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638150|NCT02383862|O1|Outcome|Feedback Group (EMR)|Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit, and whose electronic medical record of the baseline clinic visit was available for review
638151|NCT02383862|O1|Outcome|Follow up Sample Responding to SF-36 Vitality Scale (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the SF-36 vitality scale. No group comparisons were made.
638152|NCT02383862|O1|Outcome|Follow up Sample Responding to PHQ-2 (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PHQ-2. No group comparisons were made.
638153|NCT02383862|O1|Outcome|Follow up Sample Responding to GAD-2 (n=256)|Of the 300 participants invited to complete the 3-month follow up assessment, 256 participants responded to items on the GAD-2. No group comparisons were made.
638154|NCT02383862|O1|Outcome|Follow up Sample Responding to PEG (n=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on PEG. No group comparisons were made.
638155|NCT02383862|O1|Outcome|Follow up Sample Responding to PIRS-2 (N=255)|Of the 300 participants invited to complete the 3-month follow up assessment, 255 participants responded to items on the PIRS-2. No group comparisons were made.
638156|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638157|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638158|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638159|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638160|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638161|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638162|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638163|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638164|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638165|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638166|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638167|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638168|NCT02383862|O2|Outcome|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638169|NCT02383862|O1|Outcome|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638170|NCT02383862|E2|Reported Event|Control Group|Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
638335|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638171|NCT02383862|E1|Reported Event|Feedback Group|"Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit~Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores"
638172|NCT02383719|B1|Baseline|Oro-nasal Mask|Oro-nasal Mask
638173|NCT02383719|P1|Participant Flow|Oro-nasal Mask|Oro-nasal Mask
638174|NCT02383719|O1|Outcome|Oro-nasal Mask|All patients in this group received the experimental oro-nasal mask for evaluation of use. Patient's received non-invasive ventilation were switched to this mask upone study initiation.
638175|NCT02383719|E1|Reported Event|Oro-nasal Mask|Oro-nasal Mask
638176|NCT02383420|B4|Baseline|Total|Total of all reporting groups
638177|NCT02383420|B3|Baseline|Predicate & Invest.-Cadavers GOS & CsI|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
638178|NCT02383420|B2|Baseline|Predicate & Invest.-CsI|Radiation - Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
638179|NCT02383420|B1|Baseline|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
638180|NCT02383420|P3|Participant Flow|Predicate & Investigational-Cadavers|Radiation - Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
638181|NCT02383420|P2|Participant Flow|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
638182|NCT02383420|P1|Participant Flow|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
638183|NCT02383420|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-PRO 3543/C (GOS & CsI) and vice versa.
638184|NCT02383420|O2|Outcome|Investigational|DRX PRO 3543/C (GOS & CsI) Detectors, Live Subjects & Cadavers
638185|NCT02383420|O1|Outcome|Predicate|DRX-1 Detector, Live Subjects and Cadavers
638186|NCT02383420|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.
638187|NCT02383420|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
638188|NCT02383420|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
638189|NCT02382913|B11|Baseline|Total|Total of all reporting groups
638190|NCT02382913|B10|Baseline|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638191|NCT02382913|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638192|NCT02382913|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638193|NCT02382913|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638194|NCT02382913|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638195|NCT02382913|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638196|NCT02382913|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638197|NCT02382913|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638198|NCT02382913|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638199|NCT02382913|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638200|NCT02382913|P10|Participant Flow|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638201|NCT02382913|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638336|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
638202|NCT02382913|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638203|NCT02382913|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638204|NCT02382913|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638205|NCT02382913|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638206|NCT02382913|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638207|NCT02382913|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638208|NCT02382913|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638209|NCT02382913|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638210|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638211|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638212|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638213|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638214|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638215|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638216|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638217|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638218|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638219|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638220|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638221|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638222|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638223|NCT02382913|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638224|NCT02382913|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
640286|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
638225|NCT02382913|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638226|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638227|NCT02382913|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638228|NCT02382913|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638229|NCT02382913|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638230|NCT02382913|O4|Outcome|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638231|NCT02382913|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638232|NCT02382913|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638233|NCT02382913|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638234|NCT02382913|E10|Reported Event|Licensed Tdap|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638235|NCT02382913|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638236|NCT02382913|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638237|NCT02382913|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638238|NCT02382913|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638239|NCT02382913|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638240|NCT02382913|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638241|NCT02382913|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638242|NCT02382913|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638243|NCT02382913|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
638244|NCT02382640|B5|Baseline|Total|Total of all reporting groups
638245|NCT02382640|B4|Baseline|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
638256|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638257|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638246|NCT02382640|B3|Baseline|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
638247|NCT02382640|B2|Baseline|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
638248|NCT02382640|B1|Baseline|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
638249|NCT02382640|P4|Participant Flow|Regimen B, Then C, Then A, Then D|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of second intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of third intervention period (3 Days), Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of fourth intervention period (3 Days).
638250|NCT02382640|P3|Participant Flow|Regimen C, Then D, Then B, Then A|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of first intervention period (3 Days), followed by 1 week washout period, Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 of third intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of fourth intervention period (3 Days).
638251|NCT02382640|P2|Participant Flow|Regimen D, Then A, Then C, Then B|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 of first intervention period (3 Days), followed by Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 of second intervention period (3 Days), followed by 1 week washout period, followed by Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 of third intervention period (3 Days), followed by 1 week washout period, followed by Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]).
638252|NCT02382640|P1|Participant Flow|Regimen A, Then B, Then D, Then C|Regimen(Reg)A(Febuxostat XR 80mg,capsule, orally, single dose after a 10hour(hr) fast and concurrently with Maalox 20mL(200mg magnesium hydroxide, 200mg aluminum hydroxide, and 20mg simethicone/5mL)or equivalent brand antacid, suspension, orally, single dose) on Day1 of first intervention period(3 Days),followed by 1week washout period, followed by RegB(Maalox 20mL,suspension,orally, single dose after a 9hr fast,followed by Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast[or 1hr after antacid dose]) on Day1 of second intervention period(3Days),followed by 1 week washout period, followed by RegD(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast) on Day 1 of third intervention period(3Days),followed by 1week washout period, followed by RegC(Febuxostat XR 80mg,capsule, orally, single dose after a 10hr fast followed by Maalox 20mL, suspension, orally, single dose after 11hr fast[or 1hr after Febuxostat dose]) on Day1 of fourth intervention period(3 Days).
638253|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638254|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638255|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638332|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
638258|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638259|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638260|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638261|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638262|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638263|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638264|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638265|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638266|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638267|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638268|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638269|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638270|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638271|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638272|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638273|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638274|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638275|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638276|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638277|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638278|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638279|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638280|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638281|NCT02382640|O4|Outcome|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638282|NCT02382640|O3|Outcome|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638283|NCT02382640|O2|Outcome|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638284|NCT02382640|O1|Outcome|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638285|NCT02382640|E4|Reported Event|Regimen D|Regimen D (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast) on Day 1 in either of the 4 intervention periods.
638286|NCT02382640|E3|Reported Event|Regimen C|Regimen C (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast followed by Maalox 20 mL, suspension, orally, single dose after 11-hour fast [or 1 hour after Febuxostat dose]) on Day 1 in either of the 4 intervention periods.
638287|NCT02382640|E2|Reported Event|Regimen B|Regimen B (Maalox 20 mL, suspension, orally, single dose after a 9-hour fast, followed by Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast [or 1 hour after antacid dose]) on Day 1 in either of the 4 intervention periods.
638288|NCT02382640|E1|Reported Event|Regimen A|Regimen A (Febuxostat XR 80 mg, capsule, orally, single dose after a 10-hour fast and concurrently with Maalox 20 mL, suspension, orally, single dose) on Day 1 in either of the 4 intervention periods
638289|NCT02382133|B1|Baseline|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
638290|NCT02382133|P1|Participant Flow|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
638291|NCT02382133|O1|Outcome|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
638292|NCT02382133|O1|Outcome|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
638293|NCT02382133|E1|Reported Event|Nasal Alar Oxygen Sensor|"Application of a nasal alar oxygen sensor~Nasal alar oxygen sensor: Application of a nasal alar oxygen sensor"
638294|NCT02381678|B1|Baseline|All Patients Enrolled in Study|The whole group included 225 enrolled subjects. All 225 subjects included in the FAS(Full Analysis Set).
638295|NCT02381678|P3|Participant Flow|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
638296|NCT02381678|P2|Participant Flow|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
638297|NCT02381678|P1|Participant Flow|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
638298|NCT02381678|O1|Outcome|One-arm Group Included All Enrolled Subjects|This group included total 225 enrolled participants
638299|NCT02381678|E3|Reported Event|Age Group Above 70 Years Old|32 subjects implanted Perimount Heart Valve when the age was above 70
638300|NCT02381678|E2|Reported Event|Age Group Between 60 and 70 Years Old|139 subjects implanted Perimount Heart Valve when the age was between 60 and 70 years old (>=60,<70)
638301|NCT02381678|E1|Reported Event|Age Group Under 60 Years Old|54 subjects implanted Perimount Heart Valve when the age was under 60.
638302|NCT02381418|B1|Baseline|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
638303|NCT02381418|P1|Participant Flow|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 "
638304|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
638305|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg Hemagglutinin Antigen (HA) per 0.5 ml,trivalent one injection at Day 1 ~Trivalent influenza subunit vaccine Influvac: 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
638306|NCT02381418|O1|Outcome|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
638307|NCT02381418|E1|Reported Event|Influvac|"Trivalent influenza subunit vaccine Influvac. 3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
638308|NCT02381288|B5|Baseline|Total|Total of all reporting groups
638309|NCT02381288|B4|Baseline|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638310|NCT02381288|B3|Baseline|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638311|NCT02381288|B2|Baseline|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
638312|NCT02381288|B1|Baseline|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
638313|NCT02381288|P4|Participant Flow|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638314|NCT02381288|P3|Participant Flow|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638315|NCT02381288|P2|Participant Flow|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
638316|NCT02381288|P1|Participant Flow|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
638317|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638318|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638319|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
638320|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638321|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638322|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
638323|NCT02381288|O3|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638324|NCT02381288|O2|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638325|NCT02381288|O1|Outcome|TAK-448 0.1 µg|TAK-448 0.1 µg, injection, subcutaneously, once daily on Days 1 through 42.
638326|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638327|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638328|NCT02381288|O2|Outcome|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
638329|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
638330|NCT02381288|O4|Outcome|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638331|NCT02381288|O3|Outcome|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638337|NCT02381288|O1|Outcome|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
638338|NCT02381288|E4|Reported Event|TAK-448 1.0 µg|TAK-448 1.0 µg, injection, subcutaneously, once-weekly on Days 1 through 36.
638339|NCT02381288|E3|Reported Event|TAK-448 0.3 µg|TAK-448 0.3 µg, injection, subcutaneously, twice-weekly on Days 1 through 39.
638340|NCT02381288|E2|Reported Event|TAK-448 0.1 µg|TAK-448 0.1 mcg, injection, subcutaneously, once daily on Days 1 through 42.
638341|NCT02381288|E1|Reported Event|Placebo|TAK-448 placebo matching injection, subcutaneously, either once daily on Days 1 through 42, or twice weekly on Days 1 through 39 or once weekly on Days 1 through 36.
638342|NCT02380742|B3|Baseline|Total|Total of all reporting groups
638343|NCT02380742|B2|Baseline|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638344|NCT02380742|B1|Baseline|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638345|NCT02380742|P2|Participant Flow|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638346|NCT02380742|P1|Participant Flow|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638347|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638348|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638349|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638350|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638351|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638403|NCT02379637|E1|Reported Event|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
638404|NCT02378506|B1|Baseline|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638449|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
638352|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638353|NCT02380742|O2|Outcome|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638354|NCT02380742|O1|Outcome|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638355|NCT02380742|E2|Reported Event|Placebo|"4 mL of placebo cream~Placebo cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638356|NCT02380742|E1|Reported Event|Lidocaine-prilocaine|"4 mL of lidocaine-prilocaine cream~lidocaine-prilocaine cream: The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners’ finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners’ usual practice. The patient will be asked to mark her pain score for at this point"
638357|NCT02380287|B9|Baseline|Total|Total of all reporting groups
638358|NCT02380287|B8|Baseline|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
638359|NCT02380287|B7|Baseline|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
638360|NCT02380287|B6|Baseline|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
638361|NCT02380287|B5|Baseline|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
638362|NCT02380287|B4|Baseline|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
638363|NCT02380287|B3|Baseline|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
638364|NCT02380287|B2|Baseline|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
638365|NCT02380287|B1|Baseline|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
638366|NCT02380287|P8|Participant Flow|Cohort no.8|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level.~humanized monoclonal antibody against human IL-17"
638367|NCT02380287|P7|Participant Flow|Cohort no.7|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 8 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 8.~humanized monoclonal antibody against human IL-17"
638368|NCT02380287|P6|Participant Flow|Cohort no.6|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 7 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 7.~humanized monoclonal antibody against human IL-17"
638405|NCT02378506|P1|Participant Flow|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638406|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638450|NCT02375724|O1|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
638369|NCT02380287|P5|Participant Flow|Cohort no.5|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 6 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 6.~humanized monoclonal antibody against human IL-17"
638370|NCT02380287|P4|Participant Flow|Cohort no.4|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 5 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 5.~humanized monoclonal antibody against human IL-17"
638371|NCT02380287|P3|Participant Flow|Cohort no.3|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 4 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 4.~humanized monoclonal antibody against human IL-17"
638372|NCT02380287|P2|Participant Flow|Cohort no.2|"This cohort includes 3 subjects who will receive the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.~If at least 2 subjects are observed to have DLT, this dose level is defined as the MTD (unless only 3 patients have been treated at that level, in which case it is the tentative MTD). If 0 of the 3 subjects are observed to have DLT, the dose level is escalated one step for the next cohort no. 3 of 3 subjects, and the process continues as above. If exactly 1 of the 3 subjects treated show DLT, 3 additional subjects are treated at the current dose level. If none of these additional 3 patients show DLT, the dose level is escalated for the next Cohort no. 3.~humanized monoclonal antibody against human IL-17"
638373|NCT02380287|P1|Participant Flow|Cohort no.1|"This cohort includes just one subject who will receive the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously. If the dose limitating toxicity occurs within the first seven days after injection the study will be stopped. If there is no DLT within mentioned above period then Cohort no.2 is included.~humanized monoclonal antibody against human IL-17"
638374|NCT02380287|O1|Outcome|BCD-085|This cohort includes subjects who received any dose of BCD-085 subcutaneously.
638375|NCT02380287|E8|Reported Event|Cohort no.8|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 3.0 mg/kg.
638376|NCT02380287|E7|Reported Event|Cohort no.7|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 2.25 mg/kg.
638377|NCT02380287|E6|Reported Event|Cohort no.6|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.75 mg/kg.
638378|NCT02380287|E5|Reported Event|Cohort no.5|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 1.25 mg/kg.
638379|NCT02380287|E4|Reported Event|Cohort no.4|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.825 mg/kg.
638380|NCT02380287|E3|Reported Event|Cohort no.3|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.25 mg/kg.
638381|NCT02380287|E2|Reported Event|Cohort no.2|This cohort includes 3 subjects who received the single subcutaneous injection of BCD-085 at a dose of 0.05 mg/kg.
638382|NCT02380287|E1|Reported Event|Cohort no.1|This cohort includes just one subject who received the maximum safe starting dose of BCD-085 (0.05 mg/kg) subcutaneously.
638383|NCT02380261|B1|Baseline|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
638384|NCT02380261|P1|Participant Flow|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
638385|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
638386|NCT02380261|O1|Outcome|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
638387|NCT02380261|E1|Reported Event|Systane|Systane® Lid Wipes, 1 per eyelid, used once and discarded after each use, for 21 days
638388|NCT02380248|B1|Baseline|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
638389|NCT02380248|P1|Participant Flow|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID (4 times/day) in each eye for 90 days
638390|NCT02380248|O1|Outcome|Systane|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops, 1 drop QID in each eye for 90 days
638391|NCT02380248|E2|Reported Event|Systane|All subjects exposed to study treatment
638392|NCT02380248|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
638393|NCT02379637|B3|Baseline|Total|Total of all reporting groups
638394|NCT02379637|B2|Baseline|B Placebo|"Placebo~Placebo"
638395|NCT02379637|B1|Baseline|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
638396|NCT02379637|P2|Participant Flow|B Placebo|"Placebo~Placebo, matching capsules three times daily"
638397|NCT02379637|P1|Participant Flow|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine, capsules, 800 mg 3 times daily"
638398|NCT02379637|O2|Outcome|B Placebo|"Placebo~Placebo"
638399|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
638400|NCT02379637|O2|Outcome|B Placebo|"Placebo~Placebo"
638401|NCT02379637|O1|Outcome|A N-acetylcysteine|"N-acetylcysteine~N-acetylcysteine"
638402|NCT02379637|E2|Reported Event|B Placebo|"Placebo~Placebo"
640287|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
638407|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638408|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638409|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638410|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638411|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638412|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638413|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638414|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638415|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638416|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638417|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638418|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638419|NCT02378506|O1|Outcome|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638420|NCT02378506|E1|Reported Event|Etanercept|Participants with moderate to severe rheumatoid arthritis, received subcutaneous Etanercept 50 milligram (mg) once weekly up to Week 24 and were followed up to Week 28.
638421|NCT02376998|B1|Baseline|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
638422|NCT02376998|P1|Participant Flow|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta.
638423|NCT02376998|O1|Outcome|Patients With Acute Transection of Thoracic Aorta|Patients with a diagnosis of acute transection of thoracic aorta. Mortality 0%
638424|NCT02376998|E1|Reported Event|Valiant™ Endoluminal Procedure|"Data from early and long term complications following endoluminal stent-graft placement for thoracic endovascular aortic repair (TEVAR) procedure (Valiant™ endoluminal procedure) will be collected.~Valiant™ endoluminal procedure: Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:~The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.~After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak."
638425|NCT02376530|B5|Baseline|Total|Total of all reporting groups
638426|NCT02376530|B4|Baseline|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
638427|NCT02376530|B3|Baseline|Price Change|Price changes will be present during shopping session.
638428|NCT02376530|B2|Baseline|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
638429|NCT02376530|B1|Baseline|Usual Shopping|No change in condition.
638430|NCT02376530|P4|Participant Flow|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
638431|NCT02376530|P3|Participant Flow|Price Change|Price changes will be present during shopping session.
638432|NCT02376530|P2|Participant Flow|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
638433|NCT02376530|P1|Participant Flow|Usual Shopping|No change in condition.
638434|NCT02376530|O4|Outcome|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
638435|NCT02376530|O3|Outcome|Price Change|Price changes will be present during shopping session.
638436|NCT02376530|O2|Outcome|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
638437|NCT02376530|O1|Outcome|Usual Shopping|No change in condition.
638438|NCT02376530|E4|Reported Event|Nutrient Profiling and Price Change|Nutrient profiling system and price changes will be present during shopping session.
638439|NCT02376530|E3|Reported Event|Price Change|Price changes will be present during shopping session.
638440|NCT02376530|E2|Reported Event|Nutrient Profiling|Nutrient profiling system will be present during shopping session.
638441|NCT02376530|E1|Reported Event|Usual Shopping|No change in condition.
638442|NCT02375724|B3|Baseline|Total|Total of all reporting groups
638443|NCT02375724|B2|Baseline|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
638444|NCT02375724|B1|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
638445|NCT02375724|P2|Participant Flow|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
638446|NCT02375724|P1|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
638447|NCT02375724|O2|Outcome|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
638453|NCT02375724|E2|Reported Event|Placebo|Placebo BID administered by Genuair® multidose dry powder inhaler
638454|NCT02375724|E1|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg BID administered by Genuair® multidose dry powder inhaler
638455|NCT02375373|B1|Baseline|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
638456|NCT02375373|P1|Participant Flow|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
638457|NCT02375373|O1|Outcome|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
638458|NCT02375373|E1|Reported Event|Obersvational Chickpea Diet|"Observed long-term to study legume intake and GI health (Observational Chickpea Diet)~Observational Chickpea Diet: Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.~Fecal samples collected monthly."
638459|NCT02375347|B1|Baseline|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
638460|NCT02375347|P1|Participant Flow|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
638461|NCT02375347|O1|Outcome|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
638462|NCT02375347|E1|Reported Event|Chickpea Enhanced Diet|"Fed an enhanced Chickpea diet over a short term period (Chickpea Enhanced Diet Short Term)~Chickpea Enhanced Diet (Short term): Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.~Stool Samples collected at Day 1, Day 9, and Day 14."
638463|NCT02374398|B5|Baseline|Total|Total of all reporting groups
638464|NCT02374398|B4|Baseline|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
638465|NCT02374398|B3|Baseline|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638466|NCT02374398|B2|Baseline|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638467|NCT02374398|B1|Baseline|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638468|NCT02374398|P4|Participant Flow|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
638469|NCT02374398|P3|Participant Flow|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638470|NCT02374398|P2|Participant Flow|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638471|NCT02374398|P1|Participant Flow|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638472|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
638473|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638521|NCT02374164|E3|Reported Event|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
639136|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638474|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638475|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638476|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control: Standard Electro-cautery and Saline"
638477|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638478|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638479|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638480|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
638481|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638482|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638483|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638484|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
638485|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638486|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638487|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638488|NCT02374398|O4|Outcome|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
638489|NCT02374398|O3|Outcome|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638490|NCT02374398|O2|Outcome|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638491|NCT02374398|O1|Outcome|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638492|NCT02374398|E4|Reported Event|Control|"Saline will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The saline dose will be administered as a bolus over 20 minutes~Control Group: Saline and Standard Elecdrocautery"
638522|NCT02374164|E2|Reported Event|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
639134|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638493|NCT02374398|E3|Reported Event|TXA Plus Aquamantys|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes.~The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts.~Tranexamic Acid: see arm/group descriptions~Aquamantys System: see arm/group descriptions"
638494|NCT02374398|E2|Reported Event|Aquamantys System|"The Aquamantys system will be used as indicated by orthopedic surgeon intraoperative. Local temperatures under 100°C are sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels. Simultaneous RF power and saline delivery. Power settings from 20–200 watts~Aquamantys System: see arm/group descriptions"
638495|NCT02374398|E1|Reported Event|Tranexamic Acid|"TXA will be provided ready-to-use as IV infusion with instructions written by the pharmacy department. The TXA dose will be 20mg/kg to be administered as a bolus over 20 minutes~Tranexamic Acid: see arm/group descriptions"
638496|NCT02374346|B1|Baseline|Elective Surgery Patients|All adult patients admitted in our hospital for elective general, orthopaedic, gynaecologic, ear-nose-throat (ENT) and vascular procedures.
638497|NCT02374346|P1|Participant Flow|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
638498|NCT02374346|O2|Outcome|Postoperative Headache Patients Without Headache History|Factors for developing postoperative headache in patients without previous history of headache.
638499|NCT02374346|O1|Outcome|Postoperative Headache in the Total Sample|Factors for developing postoperative headache in the total number of participants
638500|NCT02374346|O1|Outcome|Elective Surgery Patients (Total Sample)|postoperative headache in elective surgery patients
638501|NCT02374346|E1|Reported Event|Elective Surgery Patients|A total number of 494 patients full fit the inclusion criteria and 446 completed the study (90.3 %).The 48 patients (9.7%) who did not complete the study were those operated or discharged during weekend.
638502|NCT02374164|B4|Baseline|Total|Total of all reporting groups
638503|NCT02374164|B3|Baseline|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
638504|NCT02374164|B2|Baseline|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
638505|NCT02374164|B1|Baseline|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
638506|NCT02374164|P3|Participant Flow|Treatment Sequence CAB|Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
638507|NCT02374164|P2|Participant Flow|Treatment Sequence BCA|Febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 1 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by Febuxostat XR 80 mg, capsules, orally, once on Day 1 of Period 3 after a high-fat meal.
638508|NCT02374164|P1|Participant Flow|Treatment Sequence ABC|Febuxostat extended release (XR) 80 mg, capsules, orally, once on Day 1 of Period 1 after a high-fat meal, followed by a 7-day washout period, followed by febuxostat XR 40 mg, capsules, orally, once on Day 1 of Period 2 after a 10-hour fast, followed by a 7-day washout period, followed by febuxostat XR 80, capsules, orally, once on Day 1 of Period 3 after a 10-hour fast.
638509|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638510|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638511|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638512|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
638513|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638514|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638515|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638516|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
638517|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638518|NCT02374164|O1|Outcome|B: Febuxostat XR 40 mg (Fasting)|Febuxostat XR 40 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638519|NCT02374164|O2|Outcome|C: Febuxostat XR 80 mg (Fasting)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods after a 10-hour fast.
638520|NCT02374164|O1|Outcome|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
638523|NCT02374164|E1|Reported Event|A: Febuxostat XR 80 mg (Fed)|Febuxostat XR 80 mg, capsules, orally, once on Day 1 in any of the 3 treatment periods 30 minutes after starting to ingest a high-fat meal.
638524|NCT02372344|B1|Baseline|AZD0585|All subjects received a single oral dose of 4 g AZD0585 on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions. Each dose was administered on Day 1 of each separate treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
638525|NCT02372344|P3|Participant Flow|Sequence CAB|"Subjects randomized to treatment sequence CAB: C=after meal / A=fasting / B=before meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
638526|NCT02372344|P2|Participant Flow|Sequence BCA|"Subjects randomized to treatment sequence BCA: B=before meal / C=after meal / A=fasting.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
638527|NCT02372344|P1|Participant Flow|Sequence ABC|"Subjects randomized to treatment sequence ABC: A=fasting / B=before meal / C=after meal.~Following an overnight fast of at least 10 hours, a single oral dose of 4 g AZD0585 was administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions."
638528|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
638529|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
638530|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
638531|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
638532|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
638533|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
638534|NCT02372344|O3|Outcome|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
638535|NCT02372344|O2|Outcome|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
638536|NCT02372344|O1|Outcome|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
638537|NCT02372344|E3|Reported Event|After Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered after consumption of a low calorie, low-fat breakfast (within 30 minutes after starting food intake).
638538|NCT02372344|E2|Reported Event|Before Meal|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered before consumption of a low calorie, low-fat breakfast (within 30 minutes before starting food intake).
638539|NCT02372344|E1|Reported Event|Fasting|Each subject received a single oral dose of 4 g AZD0585 on Day 1 of Visits 2, 3, and 4. Each dose was administered at the end of a 10-hour fast.
638540|NCT02372097|B3|Baseline|Total|Total of all reporting groups
638541|NCT02372097|B2|Baseline|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
638542|NCT02372097|B1|Baseline|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
638543|NCT02372097|P2|Participant Flow|SYR-472 50 mg + SYR-472 25 mg|SYR-472 50 mg, 1 tablet, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 25 mg, 2 tablets, orally on Day 1 of the second intervention period (8 days).
638544|NCT02372097|P1|Participant Flow|SYR-472 25 mg + SYR-472 50 mg|SYR-472 25 mg, 2 tablets, orally, on Day 1 of the first intervention period (8 days), followed by at least 13 days washout period, followed by SYR-472 50 mg, tablet, orally on Day 1 of the second intervention period (8 days).
638545|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638546|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638547|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638548|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638549|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638550|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638551|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
639135|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638552|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638553|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638554|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638555|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638556|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638557|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638558|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638559|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638560|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638561|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638562|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638563|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638564|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638565|NCT02372097|O2|Outcome|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638566|NCT02372097|O1|Outcome|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638567|NCT02372097|E2|Reported Event|SYR-472 50 mg|SYR-472 50 mg, tablet, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638568|NCT02372097|E1|Reported Event|SYR-472 25 mg|SYR-472 25 mg, 2 tablets, once orally, on Day 1 of either Period 1 or Period 2. A washout of 13 days was maintained between the two periods.
638569|NCT02372071|B1|Baseline|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
638570|NCT02372071|P1|Participant Flow|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
638571|NCT02372071|O2|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured routinely for total serum bilirubin
638572|NCT02372071|O1|Outcome|BiliCare TcB Average|"The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
638573|NCT02372071|E1|Reported Event|Preterm, Late Preterm and Term Newborns|The study population will consist of preterm, late preterm and term newborns (infants >=24 weeks gestational age)
638574|NCT02372058|B1|Baseline|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
638575|NCT02372058|P1|Participant Flow|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
638576|NCT02372058|O3|Outcome|Total Serum Bilirubin (TSB)|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured routinely for total serum bilirubin by diazo method.
638577|NCT02372058|O2|Outcome|JM103 TcB|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with the JM103 TcB device
638578|NCT02372058|O1|Outcome|BiliCare TcB Average|"The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age) measured with one BiliCare TcB device without an infection control tip and with one BiliCare TcB device with an infection control tip.~This is the average of both devices"
638579|NCT02372058|E1|Reported Event|Late Preterm and Term Newborns|The study population will consist of term and late preterm newborns (infants >=35 weeks gestational age)
638580|NCT02371876|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
638581|NCT02371876|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
638887|NCT02370615|B2|Baseline|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once on Day 3 to 8.
638582|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
638583|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
638584|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
638585|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject venous blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. BG results were compared to reference method results obtained from subject venous plasma."
638586|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Study staff tested subject fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
638587|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary palm blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
638588|NCT02371876|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick blood using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood."
638589|NCT02371876|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the ONYX PLUS Investigational Blood Glucose Monitoring System.~ONYX PLUS Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
638590|NCT02371759|B9|Baseline|Total|Total of all reporting groups
638591|NCT02371759|B8|Baseline|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638592|NCT02371759|B7|Baseline|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638593|NCT02371759|B6|Baseline|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638594|NCT02371759|B5|Baseline|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638595|NCT02371759|B4|Baseline|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638596|NCT02371759|B3|Baseline|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638597|NCT02371759|B2|Baseline|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638598|NCT02371759|B1|Baseline|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638599|NCT02371759|P8|Participant Flow|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638600|NCT02371759|P7|Participant Flow|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
639123|NCT02369796|B4|Baseline|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
638601|NCT02371759|P6|Participant Flow|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638602|NCT02371759|P5|Participant Flow|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638603|NCT02371759|P4|Participant Flow|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638604|NCT02371759|P3|Participant Flow|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638605|NCT02371759|P2|Participant Flow|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638606|NCT02371759|P1|Participant Flow|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638607|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638608|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638609|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638610|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638611|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638612|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638613|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638614|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638615|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638616|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638617|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638618|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638619|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638620|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638621|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638622|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638623|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638624|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638625|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
639124|NCT02369796|B3|Baseline|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638626|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638627|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638628|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638629|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638630|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638631|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638632|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638633|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638634|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638635|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638636|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638637|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638638|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638639|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638640|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638641|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638642|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638643|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638644|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638645|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638646|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638647|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638648|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638649|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638650|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
639125|NCT02369796|B2|Baseline|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638651|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638652|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638653|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638654|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638655|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638656|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638657|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638658|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638659|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638660|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638661|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638662|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638663|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638664|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638665|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638666|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638667|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638668|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638669|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638670|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638671|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638672|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638673|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638674|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638675|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
639126|NCT02369796|B1|Baseline|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638676|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638677|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638678|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638679|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638680|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638681|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638682|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638683|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638684|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638685|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638686|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638687|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638688|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638689|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638690|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638691|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638692|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638693|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638694|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638695|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638696|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638697|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638698|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638699|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638700|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
639127|NCT02369796|P5|Participant Flow|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
638701|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638702|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638703|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638704|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638705|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638706|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638707|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638708|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638709|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638710|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638711|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638712|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638713|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638714|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638715|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638716|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638717|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638718|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638719|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638720|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638721|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638722|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638723|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638724|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638725|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
639128|NCT02369796|P4|Participant Flow|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
638726|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638727|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638728|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638729|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638730|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638731|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638732|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638733|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638734|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638735|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638736|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638737|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638738|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638739|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638740|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638741|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638742|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638743|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638744|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638745|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638746|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638747|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638748|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638749|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638750|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
639129|NCT02369796|P3|Participant Flow|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638751|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638752|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638753|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638754|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638755|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638756|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638757|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638758|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638759|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638760|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638761|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638762|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638763|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638764|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638765|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638766|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638767|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638768|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638769|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638770|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638771|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638772|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638773|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638774|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638775|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
639130|NCT02369796|P2|Participant Flow|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638776|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638777|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638778|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638779|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638780|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638781|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638782|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638783|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638784|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638785|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638786|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638787|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638788|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638789|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638790|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638791|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638792|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638793|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638794|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638795|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638796|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638797|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638798|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638799|NCT02371759|O8|Outcome|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638800|NCT02371759|O7|Outcome|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
639131|NCT02369796|P1|Participant Flow|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638801|NCT02371759|O6|Outcome|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638802|NCT02371759|O5|Outcome|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638803|NCT02371759|O4|Outcome|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638804|NCT02371759|O3|Outcome|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638805|NCT02371759|O2|Outcome|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638806|NCT02371759|O1|Outcome|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638807|NCT02371759|E8|Reported Event|Healthy: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638808|NCT02371759|E7|Reported Event|Healthy: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638809|NCT02371759|E6|Reported Event|Healthy: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638810|NCT02371759|E5|Reported Event|Healthy: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638811|NCT02371759|E4|Reported Event|Diabetics: L+E Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + epinephrine (1:80.000) for mandibular block anesthesia~L+E mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638812|NCT02371759|E3|Reported Event|Diabetics: L+E Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%)+ epinephrine (1:80.000) for maxillary infiltration anesthesia~L+E maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)"
638813|NCT02371759|E2|Reported Event|Diabetics: L+C Mandibular Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for mandibular block anesthesia~L+C mandibular anesthesia: Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638814|NCT02371759|E1|Reported Event|Diabetics: L+C Maxillary Anesthesia|"Single dose intraoral local anesthesia with 2ml lidocaine (2%) + clonidine (15 mcg/ml) for maxillary infiltration anesthesia~L+C maxillary anesthesia: Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)"
638815|NCT02370914|B1|Baseline|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
638816|NCT02370914|P1|Participant Flow|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
638817|NCT02370914|O1|Outcome|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
638818|NCT02370914|E1|Reported Event|Diagnostic Device - Nautilus NeuroWave|"Nautilus NeuroWave diagnostic device. Recordings were evaluated by a Jan Medical concussion algorithm .~Nautilus NeuroWaveTM System: Recording of subjects with Nautilus NeuroWave diagnostic device"
638819|NCT02370667|B4|Baseline|Total|Total of all reporting groups
638820|NCT02370667|B3|Baseline|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.~Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
638821|NCT02370667|B2|Baseline|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.~Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
638846|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
640288|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
638822|NCT02370667|B1|Baseline|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.~Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
638823|NCT02370667|P3|Participant Flow|Meditation Control (M)|"The participants in this arm will be asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. This will take place at an alternate yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group will be offered a free exercise pass following completion of the study.~Meditation Control (M): A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
638824|NCT02370667|P2|Participant Flow|Traditional Exercise (TE)|"The participants in this arm will be prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program will include 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants will be asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers will be available during all class times for program completion and progression.~Traditional Exercise (TE): A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
638825|NCT02370667|P1|Participant Flow|Biomechanical Exercise (BE)|"The participants in this arm will be asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times will be offered per week. These classes will include a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements will be obtained at baseline (before intervention) and at follow-up (following intervention). Outcomes will include clinical mobility; muscle and fat volumes, and cartilage morphology using MRI; pain; isometric leg strength; cardiovascular fitness; and gait analysis.~Biomechanical Exercise (BE): A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis."
638826|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638827|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638828|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638829|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638830|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638831|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638832|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638833|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638834|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638835|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638836|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638837|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638838|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638839|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638840|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638841|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638842|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638843|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638844|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638845|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638847|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638848|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638849|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638850|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638851|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638852|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638853|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638854|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638855|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638856|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638857|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638858|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638859|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638860|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638861|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638862|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638863|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638864|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638865|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638866|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638867|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638868|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638869|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638870|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638871|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638872|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638873|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638874|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638875|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638876|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638877|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638878|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638879|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638880|NCT02370667|O3|Outcome|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638881|NCT02370667|O2|Outcome|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638882|NCT02370667|O1|Outcome|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638883|NCT02370667|E3|Reported Event|Meditation Control (M)|The participants in this arm were asked to attend 3 meditation classes per week for 12 weeks taught by a certified yoga instructor with a specialization in meditation. These classes took place at an alternate area of the yoga studio to avoid contamination. Since it is known that exercise is beneficial for pain management and strengthening in knee OA, participants randomized to the control group were offered a free exercise pass following completion of the study. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638884|NCT02370667|E2|Reported Event|Traditional Exercise (TE)|The participants in this arm were prescribed an aerobic and strengthening exercise program often prescribed to those with knee OA. The program included 15 minutes of walking per class, closed kinetic chain strengthening exercises on machines, and a cool down consisting of stretching. Participants were asked to come to class 3 times per week for 12 weeks. Certified Kinesiologists as well as student volunteers were available during all class times for program completion and progression. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638885|NCT02370667|E1|Reported Event|Biomechanical Exercise (BE)|The participants in this arm were asked to attend 3 group classes per week for 12 weeks at a local yoga studio taught by a certified yoga instructor. Four class times were offered per week. These classes included a warm-up, static poses shown to decrease knee joint loading, and a cool down including flexibility exercises. Measurements were obtained at baseline (before intervention) and at follow-up (following intervention).
638886|NCT02370615|B3|Baseline|Total|Total of all reporting groups
638888|NCT02370615|B1|Baseline|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638889|NCT02370615|P2|Participant Flow|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638890|NCT02370615|P1|Participant Flow|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638891|NCT02370615|O1|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638892|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638893|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638894|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638895|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638896|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638897|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638898|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638899|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638900|NCT02370615|O2|Outcome|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 1 and 7, followed by Digoxin 0.25 mg, tablet, orally once on Day 1 and 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638901|NCT02370615|O1|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638902|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638903|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
638904|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638905|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
638906|NCT02370615|O2|Outcome|Cohort 2: Midazolam + TAK-272|Midazolam 2 mg, syrup, orally, once on Day 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638907|NCT02370615|O1|Outcome|Cohort 2: Midazolam|Midazolam 2 mg, syrup, orally, once on Day 1.
638908|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638909|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
638910|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638911|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
638912|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638913|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
638914|NCT02370615|O2|Outcome|Cohort 2: Digoxin + TAK-272|Digoxin 0.25 mg, tablet, orally once on Day 7, further followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638915|NCT02370615|O1|Outcome|Cohort 2: Digoxin|Digoxin 0.25 mg, tablet, orally once on Day 1 and 7.
638916|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638917|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
638918|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638919|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
638920|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638921|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
638922|NCT02370615|O2|Outcome|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 mg, tablet, orally, once on Day 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638923|NCT02370615|O1|Outcome|Cohort 1: TAK-272|TAK-272 40 mg, tablet, orally, once on Day 1.
638924|NCT02370615|E2|Reported Event|Cohort 2: Midazolam + Digoxin + TAK-272|Midazolam 2 mg, syrup, and Digoxin 0.25 mg, tablet, orally, once on Day 1 and 7, followed by TAK-272 80 mg, tablet, orally, once from Day 3 to 8.
638925|NCT02370615|E1|Reported Event|Cohort 1: TAK-272 + Itraconazole|TAK-272 40 milligram (mg), tablet, orally, once on Day 1 and 10, followed by Itraconazole 200 mg, solution, orally, twice on Day 4, further followed by Itraconazole 200 mg, solution, orally, once from Day 5 to 12.
638926|NCT02370602|B7|Baseline|Total|Total of all reporting groups
638927|NCT02370602|B6|Baseline|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638928|NCT02370602|B5|Baseline|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638929|NCT02370602|B4|Baseline|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638930|NCT02370602|B3|Baseline|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638931|NCT02370602|B2|Baseline|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638932|NCT02370602|B1|Baseline|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
638933|NCT02370602|P6|Participant Flow|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638934|NCT02370602|P5|Participant Flow|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638935|NCT02370602|P4|Participant Flow|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638936|NCT02370602|P3|Participant Flow|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638937|NCT02370602|P2|Participant Flow|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638938|NCT02370602|P1|Participant Flow|[^11C]T-773 Only|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
638939|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638940|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638941|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638942|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638943|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638944|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638945|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638946|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638947|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638948|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639132|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
638949|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638950|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638951|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638952|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638953|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638954|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638955|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638956|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638957|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638958|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638959|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638960|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638961|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638962|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638963|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638964|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638965|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638966|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638967|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638968|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638969|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638970|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638971|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
640289|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
638972|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638973|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638974|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638975|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638976|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638977|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638978|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638979|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638980|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638981|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638982|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638983|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638984|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638985|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638986|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638987|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638988|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638989|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
638990|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638991|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638992|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638993|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638994|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
640290|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
638995|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638996|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638997|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
638998|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
638999|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
639000|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639001|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639002|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
639003|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
639004|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639005|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
639006|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639007|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639008|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
639009|NCT02370602|O6|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
639010|NCT02370602|O5|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639011|NCT02370602|O4|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
639012|NCT02370602|O3|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639013|NCT02370602|O2|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639014|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
639015|NCT02370602|O2|Outcome|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
639016|NCT02370602|O1|Outcome|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
639017|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639018|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
639019|NCT02370602|O2|Outcome|TAK-063 10 mg + [^11C]T-773|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639020|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639133|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639021|NCT02370602|O5|Outcome|TAK-063 1000 mg + [^11C]T-773|TAK-063 1000 mg, tablets, orally, once, on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 and twice on Day 2 (before and after administration of TAK-063).
639022|NCT02370602|O4|Outcome|TAK-063 100 mg + [^11C]T-773|TAK-063 100 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639023|NCT02370602|O3|Outcome|TAK-063 30 mg + [^11C]T-773|For main cohort, TAK-063 30 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2. For pilot cohort, TAK-063 30 mg, tablets, orally, once on Day 2, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, once on Day 1 (before and after administration of TAK-063) and twice on Day 2.
639024|NCT02370602|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639025|NCT02370602|O1|Outcome|TAK-063 3 mg + [^11C]T-773|TAK-063 3 mg, tablets, orally, once, on Day 1, and [^11C]T-773 <8 μg; 400MBq ± 10%, intravenously (IV), prior to PET scans, twice on Day 1 (before and after administration of TAK-063) and once on Day 2.
639026|NCT02370602|E2|Reported Event|TAK-063|TAK-063 3 to 1000 mg, tablets, orally, once, on Day 1.
639027|NCT02370602|E1|Reported Event|[^11C]T-773|[^11C]T-773 <8 μg; 400MBq ± 10%, intravenous (IV), once on Days 1 and 2 only.
639028|NCT02370537|B4|Baseline|Total|Total of all reporting groups
639029|NCT02370537|B3|Baseline|Normal FEC (EPANOVA® and OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
639030|NCT02370537|B2|Baseline|Intermediate FEC (EPANOVA® and OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
639031|NCT02370537|B1|Baseline|Low FEC (EPANOVA® and OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function.
639032|NCT02370537|P3|Participant Flow|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639033|NCT02370537|P2|Participant Flow|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC as a measure of pancreatic exocrine function in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639034|NCT02370537|P1|Participant Flow|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially triglycerides (TGs) and faecal elastase-1 concentration (FEC) as a measure of pancreatic exocrine function in the study population. Patients in the Low FEC group were determined to have FEC levels <100 microgram per gram (mcg/g). No treatment was administered in Part A which was a recruitment phase for Part B. In Part B, study treatment was administered at Visit 4 and Visit 7 with a randomised crossover design to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639035|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639036|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639037|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639038|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639039|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639040|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
640291|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
639041|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639042|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639043|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639044|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639045|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639046|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639047|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639048|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639049|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639050|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639051|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639052|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639053|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639054|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639055|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639056|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639097|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639057|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639058|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639059|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639060|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639061|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639062|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639063|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639064|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639065|NCT02370537|O6|Outcome|Normal FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639066|NCT02370537|O5|Outcome|Normal FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with normal FEC, ≥ 200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639067|NCT02370537|O4|Outcome|Intermediate FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639068|NCT02370537|O3|Outcome|Intermediate FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with intermediate FEC, ≥ 100 to <200 mcg/g, were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639069|NCT02370537|O2|Outcome|Low FEC (OMACOR®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639070|NCT02370537|O1|Outcome|Low FEC (EPANOVA®)|In Part B, study treatment was administered at Visit 4 (Day 21+5) and Visit 7 (10 to 14 days after Visit 4) with a randomised crossover design. Patients with low FEC, <100 mcg/g were randomised in Part B to a treatment sequence: AB (a single dose of EPANOVA® 4 g followed by a single dose of OMACOR® 4 g) or BA (a single dose of OMACOR® 4 g followed by a single dose of EPANOVA® 4 g).
639071|NCT02370537|O3|Outcome|Normal FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Normal FEC group were determined to have FEC levels ≥200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
639072|NCT02370537|O2|Outcome|Intermediate FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Intermediate FEC group were determined to have FEC levels ≥100 mcg/g to <200 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
639073|NCT02370537|O1|Outcome|Low FEC (EPANOVA® and OMACOR®)|Part A investigated serum lipids, especially TGs and FEC to assess the relationship between serum TGs and degree of pancreatic exocrine function (as measured by FEC) in the study population. Patients in the Low FEC group were determined to have FEC levels <100 mcg/g. No treatment was administered in Part A which was a recruitment phase for Part B.
639074|NCT02370537|E6|Reported Event|Normal FEC (OMACOR®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
639075|NCT02370537|E5|Reported Event|Normal FEC (EPANOVA®)|Patients had normal levels (≥200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
639076|NCT02370537|E4|Reported Event|Intermediate FEC (OMACOR®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
639077|NCT02370537|E3|Reported Event|Intermediate FEC (EPANOVA®)|Patients had intermediate levels (≥100 to <200 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
639078|NCT02370537|E2|Reported Event|Low FEC (OMACOR®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of OMACOR® 4 g at Visit 4 were reported for this group.
639079|NCT02370537|E1|Reported Event|Low FEC (EPANOVA®)|Patients had low levels (<100 mcg/g) of FEC, as determined by the average of the FEC from 2 stool samples collected between Visit 2 and Visit 3 as a measure of pancreatic exocrine function. AEs with an onset date on or after the date of administration of EPANOVA® 4 g at Visit 4 were reported for this group.
639080|NCT02370121|B3|Baseline|Total|Total of all reporting groups
639081|NCT02370121|B2|Baseline|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639082|NCT02370121|B1|Baseline|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639083|NCT02370121|P2|Participant Flow|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639084|NCT02370121|P1|Participant Flow|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639085|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639086|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639087|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639088|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639089|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639090|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639091|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639092|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639093|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639094|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639095|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639096|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
640292|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
639098|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639099|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639100|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639101|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639102|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639103|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639104|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639105|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639106|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639107|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639108|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639109|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639110|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639111|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639112|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639113|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639114|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639115|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639116|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639117|NCT02370121|O2|Outcome|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639118|NCT02370121|O1|Outcome|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639119|NCT02370121|E2|Reported Event|Gymnema Sylvestre|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Gymnema Sylvestre: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639120|NCT02370121|E1|Reported Event|Placebo|"600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.~Placebo: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days."
639121|NCT02369796|B6|Baseline|Total|Total of all reporting groups
639122|NCT02369796|B5|Baseline|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639137|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639138|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639139|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639140|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639141|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639142|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639143|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639144|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639145|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639146|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639147|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639148|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639149|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639150|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639151|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639152|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639153|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639154|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639155|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639156|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639157|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639158|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639159|NCT02369796|O2|Outcome|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639160|NCT02369796|O1|Outcome|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639161|NCT02369796|O3|Outcome|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639162|NCT02369796|O2|Outcome|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639163|NCT02369796|O1|Outcome|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639164|NCT02369796|E5|Reported Event|TAK-448 0.1 µg Twice Weekly|TAK-448 0.1 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639165|NCT02369796|E4|Reported Event|TAK-448 0.3 µg Twice Weekly|TAK-448 0.3 µg, subcutaneous injection, twice weekly on Days 1, 4, 8, 11, 15, 18, 22, and 25.
639166|NCT02369796|E3|Reported Event|TAK-448 0.3 µg Once Weekly|TAK-448 0.3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639167|NCT02369796|E2|Reported Event|TAK-448 1 µg Once Weekly|TAK-448 1 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639168|NCT02369796|E1|Reported Event|TAK-448 3 µg Once Weekly|TAK-448 3 µg, subcutaneous injection, once weekly on Days 1, 8, 15 and 22.
639169|NCT02369341|B3|Baseline|Total|Total of all reporting groups
639170|NCT02369341|B2|Baseline|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639171|NCT02369341|B1|Baseline|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639172|NCT02369341|P2|Participant Flow|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639173|NCT02369341|P1|Participant Flow|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639174|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639175|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639176|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639177|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639388|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639178|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639179|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639180|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639181|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639182|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639183|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639184|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639185|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639186|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639187|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639188|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639189|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639190|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639191|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639192|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639193|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639194|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639195|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639196|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639197|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639198|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639199|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639200|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639201|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639386|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639202|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639203|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639204|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639205|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639206|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639207|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639208|NCT02369341|O4|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_N|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639209|NCT02369341|O3|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group_Y|Subjects aged >60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639210|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_N|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had not received vaccination in 2014.
639211|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group_Y|Subjects aged 18-60 years administered with the study vaccine [1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0, administered intramuscularly in the deltoid of the non-dominant arm] and who had received vaccination in 2014.
639212|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639213|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639214|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639215|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639216|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639217|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639218|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639219|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639220|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639221|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639222|NCT02369341|O2|Outcome|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged >60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639223|NCT02369341|O1|Outcome|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639224|NCT02369341|E2|Reported Event|Fluarix Tetra (Southern Hemisphere) Elderly Group|Subjects aged ˃60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639225|NCT02369341|E1|Reported Event|Fluarix Tetra (Southern Hemisphere) Adult Group|Subjects aged 18-60 years received 1 dose of Fluarix™ Tetra (Southern Hemisphere) vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
639226|NCT02368457|B3|Baseline|Total|Total of all reporting groups
639227|NCT02368457|B2|Baseline|Control Group|No drug treatment
639387|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
640293|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
639228|NCT02368457|B1|Baseline|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
639229|NCT02368457|P2|Participant Flow|Control Group|No drug treatment
639230|NCT02368457|P1|Participant Flow|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
639231|NCT02368457|O2|Outcome|CONTROL|No drug treatment
639232|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
639233|NCT02368457|O2|Outcome|Control Group|Standard treatment
639234|NCT02368457|O1|Outcome|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
639235|NCT02368457|E2|Reported Event|Control Group|Standard treatment
639236|NCT02368457|E1|Reported Event|Pentoxifylline and Tocopherol|"Drug: pentoxifylline with tocopherol Combination of pentoxifylline and tocopherol during a minimum of 6 months and a maximum of 24 months.~Pentoxifylline and Tocopherol: pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum)."
639237|NCT02368314|B3|Baseline|Total|Total of all reporting groups
639238|NCT02368314|B2|Baseline|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639239|NCT02368314|B1|Baseline|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639240|NCT02368314|P2|Participant Flow|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639241|NCT02368314|P1|Participant Flow|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639242|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639243|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639244|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639245|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639246|NCT02368314|O2|Outcome|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639247|NCT02368314|O1|Outcome|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639248|NCT02368314|E2|Reported Event|Clexane|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of Clexane 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery/~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639249|NCT02368314|E1|Reported Event|BCD-080|"Sodium enoxaparine 40 mg (4 000 anti-Xa IU / 0,4 ml) at pre-filled syringe. Administration of BCD-080 30 mg (0,3 ml) every 12 hours during 14 days after surgery for preventing venous thromboembolic complications after surgery.~Sodium Enoxaparine: 30 mg (0,3 ml), subcutaneously, twice a day (every 12 h)."
639250|NCT02368093|B3|Baseline|Total|Total of all reporting groups
639251|NCT02368093|B2|Baseline|Placebo|Placebo pills with the same appearance as Detosiv tablets once daily for 6 months.
639252|NCT02368093|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast for 6 months
639283|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639253|NCT02368093|P2|Participant Flow|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
639254|NCT02368093|P1|Participant Flow|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
639255|NCT02368093|O2|Outcome|Placebo|placebo pills with the same appearance as Detosiv tablets.
639256|NCT02368093|O1|Outcome|Dextromethorphan Hydrobromide|"Dextromethorphan hydrobromide; Detosiv Slow Release® (60mg per tablet, Lotus Pharmaceutical Company, Taipei, Taiwan), 120mg per day with once daily dose taken after breakfast]~Dextromethorphan hydrobromide: 120mg per day with once daily dose taken after breakfast for 6 months"
639257|NCT02368093|E2|Reported Event|Placebo|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Placebo pills with the same appearance as Dextromethorphan hydrobromide tablets once daily were given for 6 months."
639258|NCT02368093|E1|Reported Event|Dextromethorphan|"Biologic-naïve rheumatoid arthritis patients who fulfilled the 2010 criteria of the American College of Rheumatology for RA were enrolled.~Dextromethorphan hydrobromide 120mg once daily were given for 6 months."
639259|NCT02367885|B4|Baseline|Total|Total of all reporting groups
639260|NCT02367885|B3|Baseline|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639261|NCT02367885|B2|Baseline|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639262|NCT02367885|B1|Baseline|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639263|NCT02367885|P3|Participant Flow|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639264|NCT02367885|P2|Participant Flow|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639265|NCT02367885|P1|Participant Flow|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639266|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639267|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639268|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639269|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639270|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639271|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639272|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639273|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639274|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639275|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639276|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639277|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639278|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639279|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639280|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639281|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639282|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639284|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639285|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639286|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639287|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639288|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639289|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639290|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639291|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639292|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639293|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639294|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639295|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639296|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639297|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639298|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639299|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639300|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639301|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639302|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639303|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639304|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639305|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639306|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639307|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639308|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639309|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639310|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639311|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639312|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639348|NCT02367391|E2|Reported Event|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639313|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639314|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639315|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639316|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639317|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639318|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639319|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639320|NCT02367885|O3|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639321|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639322|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639323|NCT02367885|O2|Outcome|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639324|NCT02367885|O1|Outcome|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639325|NCT02367885|O1|Outcome|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639326|NCT02367885|E3|Reported Event|TAK-850 0.5 mL: 13-19 Years|Participants aged 13 to 19 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 in a treatment period of 22 days.
639327|NCT02367885|E2|Reported Event|TAK-850 0.5 mL: 3-12 Years|Participants aged 3 to 12 years received TAK-850 0.5 mL (15 mcg/0.5 mL of HA antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639328|NCT02367885|E1|Reported Event|TAK-850 0.25 mL: 6-35 Months|Participants aged 6 to 35 months received TAK-850 0.25 mL (15 microgram [mcg]/0.5 mL of hemagglutinin [HA] antigen per strain), injection, intramuscularly on Day 1 and 22 in a treatment period of 43 days.
639329|NCT02367391|B3|Baseline|Total|Total of all reporting groups
639330|NCT02367391|B2|Baseline|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639331|NCT02367391|B1|Baseline|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639332|NCT02367391|P2|Participant Flow|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639333|NCT02367391|P1|Participant Flow|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639334|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639335|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639336|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639337|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639338|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639339|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639340|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639341|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639342|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639343|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639344|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639345|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639346|NCT02367391|O2|Outcome|Control|Control: Usual Care. All participants receive the active medication, Varenicline.
639347|NCT02367391|O1|Outcome|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639379|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639349|NCT02367391|E1|Reported Event|Motivational Text Messages|Motivational Text Messages: Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
639350|NCT02367170|B3|Baseline|Total|Total of all reporting groups
639351|NCT02367170|B2|Baseline|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
639352|NCT02367170|B1|Baseline|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
639353|NCT02367170|P2|Participant Flow|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
639354|NCT02367170|P1|Participant Flow|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
639355|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
639356|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
639357|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
639358|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
639359|NCT02367170|O2|Outcome|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
639360|NCT02367170|O1|Outcome|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
639361|NCT02367170|E2|Reported Event|SHAM Group|SHAM training will also be conducted five days per week with an identical training device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout.
639362|NCT02367170|E1|Reported Event|IMST Intervention Group|IMST will be conducted 5 days per week by study staff using a threshold inspiratory muscle training device (Respironics model 735). Prior to training, the tracheal cuff pressure is assessed to ensure no air leakage and appropriate inflation. The IMST training takes approximately 15 minutes to complete. To perform IMST, FiO2 is increased for 2 minutes prior to each training bout to maintain oxygen saturation more than 92%.
639363|NCT02367066|B3|Baseline|Total|Total of all reporting groups
639364|NCT02367066|B2|Baseline|Placebo-AZD1981|Sequence Placebo-AZD1981
639365|NCT02367066|B1|Baseline|AZD1981-Placebo|Sequence AZD1981-Placebo
639366|NCT02367066|P2|Participant Flow|Placebo-AZD1981|Sequence Placebo-AZD1981
639367|NCT02367066|P1|Participant Flow|AZD1981-Placebo|Sequence AZD1981-Placebo
639368|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639369|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
639370|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639371|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
639372|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639373|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
639374|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639375|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
639376|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639377|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639378|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639390|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639391|NCT02367066|O1|Outcome|MMTT|Mixed Meal Tolerance Test (MMTT)
639392|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 Infusion)
639393|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
639394|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded Glucose and GLP1 infusion)
639395|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
639396|NCT02367066|O2|Outcome|GGI (Graded Glucose and GLP1 Infusion)|GGI (Graded glucose and GLP1 infusion)
639397|NCT02367066|O1|Outcome|MMTT|MMTT (Mixed Meal Tolerance Test)
639398|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639399|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639400|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639401|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639402|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639403|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639404|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639405|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639406|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639407|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639408|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639409|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639410|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639411|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639412|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639413|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639414|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639415|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639416|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639417|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639418|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639419|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639420|NCT02367066|O2|Outcome|Placebo|Placebo, oral tablet
639421|NCT02367066|O1|Outcome|AZD1981|AZD1981, oral tablet
639422|NCT02367066|E2|Reported Event|Placebo|Placebo, oral tablet
639423|NCT02367066|E1|Reported Event|AZD1981|AZD1981, oral tablet
639424|NCT02366936|B1|Baseline|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.~Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
639425|NCT02366936|P1|Participant Flow|Use of Tortle Midliner|"This study will be an interventional, longitudinal study of 30 preterm infants using the Tortle Midliner.~Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g."
639426|NCT02366936|O1|Outcome|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
639427|NCT02366936|O1|Outcome|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
639428|NCT02366936|E1|Reported Event|Use of Tortle Midliner|Tortle Midliner: The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant’s head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
639429|NCT02366923|B1|Baseline|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
639430|NCT02366923|P1|Participant Flow|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
639431|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639457|NCT02366767|P2|Participant Flow|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
639432|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639433|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639434|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639435|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639436|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639437|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639438|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639439|NCT02366923|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639440|NCT02366923|O1|Outcome|Stenfilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~stenfilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639441|NCT02366923|E1|Reported Event|Overall Participants|"Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table.~stenfilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table~delefilcon A: Two contact lenses will be randomized to right and left eyes (contra lateral wear) according to the randomization table"
639442|NCT02366910|B1|Baseline|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639443|NCT02366910|P1|Participant Flow|Overall Participants|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye.~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639444|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639445|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639446|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639447|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639448|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639449|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639450|NCT02366910|O2|Outcome|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639451|NCT02366910|O1|Outcome|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639452|NCT02366910|E2|Reported Event|Delefilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~delefilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639453|NCT02366910|E1|Reported Event|Omafilcon A|"Each subject will be randomized to wear the test lens in one eye and control lens in the other eye (contra lateral design).~omafilcon A: Each subject randomized to wear either the test or control in either the left of right eye."
639454|NCT02366767|B3|Baseline|Total|Total of all reporting groups
639455|NCT02366767|B2|Baseline|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
639456|NCT02366767|B1|Baseline|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
639520|NCT02366338|B4|Baseline|Total|Total of all reporting groups
639521|NCT02366338|B3|Baseline|Group 3|Patients on dabigatran therapy
639458|NCT02366767|P1|Participant Flow|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
639459|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
639460|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
639461|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
639462|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
639463|NCT02366767|O2|Outcome|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
639464|NCT02366767|O1|Outcome|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
639465|NCT02366767|E2|Reported Event|Control|"The subjects in the control arm will wear the 530G system using Enlite and MiniLink transmitter and threshold suspend.~Control: Threshold suspend"
639466|NCT02366767|E1|Reported Event|Automatic Closed-loop Insulin Delivery|"The closed-loop arm will consist of participants wearing a sensor and transmitter which transmits sensor glucose data. The algorithm determines insulin delivery rates and this is delivered in microboluses every 5 minutes~Automatic closed-loop insulin delivery: Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes."
639467|NCT02366689|B4|Baseline|Total|Total of all reporting groups
639468|NCT02366689|B3|Baseline|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639469|NCT02366689|B2|Baseline|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639470|NCT02366689|B1|Baseline|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639471|NCT02366689|P3|Participant Flow|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639472|NCT02366689|P2|Participant Flow|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639473|NCT02366689|P1|Participant Flow|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639474|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639475|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639476|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639522|NCT02366338|B2|Baseline|Group 2|patients on rivaroxaban therapy
639523|NCT02366338|B1|Baseline|Group 1|patients on warfarin therapy
639494|NCT02366689|E1|Reported Event|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639477|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639478|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639479|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639480|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639481|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639482|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639483|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639484|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639485|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639486|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639487|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639488|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639489|NCT02366689|O3|Outcome|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639490|NCT02366689|O2|Outcome|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639491|NCT02366689|O1|Outcome|Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration)."
639492|NCT02366689|E3|Reported Event|Fluoride Only Toothpaste + Mouthwash|"Fluoride only toothpaste + Fluoride only Mouthwash~fluoride only toothpaste: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.~Fluoride only mouthwash: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds."
639493|NCT02366689|E2|Reported Event|Toothpaste + Mouthwash|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).~Cetylpyridinium chloride mouthwash: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds."
639495|NCT02366637|B1|Baseline|All Participants|All participants who received at least 1 dose of study drug (PF-03715455 or placebo).
639496|NCT02366637|P2|Participant Flow|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639497|NCT02366637|P1|Participant Flow|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639498|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639499|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639500|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639501|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639502|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639503|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639504|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639505|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639506|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639507|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639508|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639509|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639510|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639511|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639512|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639513|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639514|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639515|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639516|NCT02366637|O2|Outcome|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639517|NCT02366637|O1|Outcome|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639518|NCT02366637|E2|Reported Event|Placebo|Matching placebo was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639519|NCT02366637|E1|Reported Event|PF-03715455 680 mcg Twice Daily|PF-03715455 680 mcg dry powder capsule was administered by oral inhalation twice daily via a Miat mondose inhaler device for 4 weeks in each treatment period. Dosing in each treatment period was separated by a washout period of 28 to 49 days.
639533|NCT02365688|B1|Baseline|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
639534|NCT02365688|P1|Participant Flow|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
639535|NCT02365688|O1|Outcome|Initial Bolus Pre-incision|"Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded~Initial bolus pre-incision: Measured hemodynamic response to pre-incision bolus"
639536|NCT02365688|E1|Reported Event|Pre-surgical Bolus|Pre-surgical bolus of 500 cc before incision rather than during incision for baseline hemodynamic data
639537|NCT02364778|B3|Baseline|Total|Total of all reporting groups
639538|NCT02364778|B2|Baseline|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
639539|NCT02364778|B1|Baseline|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
639540|NCT02364778|P1|Participant Flow|Provisional Stenting Strategy|Patients with stable coronary artery disease with angiographic main vessel lesion not involving side branch (SB) in whom provisional stenting strategy is planned.
639541|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
639542|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
639543|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
639544|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
639545|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
639546|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
639547|NCT02364778|O2|Outcome|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
639548|NCT02364778|O1|Outcome|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
639549|NCT02364778|E2|Reported Event|SB Ostium DS ≤50%|Side branch (SB) ostium diameter stenosis (DS) ≤50%
639550|NCT02364778|E1|Reported Event|SB Ostium DS >50%|Side branch (SB) ostium diameter stenosis (DS) >50%
639551|NCT02364180|B1|Baseline|Pyridostigmine Bromide Treatment Group|All subjects investigated were taking pyridostigmine.
639552|NCT02364180|P1|Participant Flow|Pyridostigmine Bromide Treatment Group|pyridostigmine bromide treatment is a single arm. Subjects must be treated with pyridostigmine for at least 6months and must not be treated for myasthenia gravis.
639553|NCT02364180|O1|Outcome|Pyridostigmine Bromide Treatment Group|Subjects taking pyridostigmine bromide for more than 6 months for a condition other than myasthenia gravis
639554|NCT02364180|E1|Reported Event|Pyridostigmine Bromide Treatment Group|In all enrolled subjects (10), who were known pyridostigmine bromide pts that were observed with Electromyography (EMG), there were no adverse events anticipated.
639555|NCT02363478|B1|Baseline|Buspirone|22 out of 30 participants (19 female) completed the study.
639556|NCT02363478|P1|Participant Flow|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
639557|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
639558|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
639559|NCT02363478|O1|Outcome|Buspirone|"4-weeks buspirone administration (20mg) in patients with SSc and esophageal involvement~buspirone: buspirone 10 mg X2 for 4 weeks"
639560|NCT02363478|O1|Outcome|Buspirone|Participants received buspirone 20 mg/day for 4 weeks
639561|NCT02363478|E1|Reported Event|Buspirone|Participants received bouspirone 20 mg/day for 4 weeks
639562|NCT02362412|B1|Baseline|All Study Participants|Participants who received either FK949E 50 mg tablets or FK949E 150 mg tablets once daily. The analysis population was the Full Analysis Set (FAS), which consisted of all participants who received at least one dose of the study drug and who had at least one efficacy measurement after the start of treatment with the study drug.
639563|NCT02362412|P2|Participant Flow|FK949E 150 mg / FK949E 50 mg|Participants who received the 150 mg tablet once daily during Treatment Period II (8 weeks) and 50 mg tablet once daily during Treatment Period III (8 weeks).
639564|NCT02362412|P1|Participant Flow|FK949E 50 mg / FK949E 150 mg|Participants who received the 50 mg tablet once daily during Treatment Period II (8 weeks) and 150 mg tablet once daily during Treatment Period III (8 weeks).
639565|NCT02362412|O4|Outcome|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
639566|NCT02362412|O3|Outcome|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
639567|NCT02362412|O2|Outcome|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period II (8 weeks).
639568|NCT02362412|O1|Outcome|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
639569|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639570|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639571|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639572|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639573|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639574|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639575|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639699|NCT02359955|O1|Outcome|Duration of Right Masseter of Zero Degree Teeth|emg parameter of patients treated with zero degree teeth
639576|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639577|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639578|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639579|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639580|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639581|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639582|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639583|NCT02362412|O2|Outcome|FK949E 150 mg Tablets|Participants who received FK949E 150 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639584|NCT02362412|O1|Outcome|FK949E 50 mg Tablets|Participants who received FK949E 50 mg tablets once daily in either Treatment Period II (8 weeks) or Treatment Period III (8 weeks).
639585|NCT02362412|E4|Reported Event|Treatment Period III FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period III (8 weeks).
639586|NCT02362412|E3|Reported Event|Treatment Period III FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily during Treatment Period III (8 weeks).
639587|NCT02362412|E2|Reported Event|Treatment Period II FK949E 150 mg|Participants who received FK949E 150 mg tablets once daily duringr Treatment Period II (8 weeks).
639588|NCT02362412|E1|Reported Event|Treatment Period II FK949E 50 mg|Participants who received FK949E 50 mg tablets once daily during Treatment Period II (8 weeks).
639589|NCT02362373|B1|Baseline|Levonorgestrel IUS|"all women in the study underwent placement of the levonorgestrel IUS in an open-label fashion, outcomes were compared before and after placement.~levonorgestrel IUS: placement of levonorgestrel intrauterine system"
639590|NCT02362373|P1|Participant Flow|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
639591|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
639592|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
639593|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
639594|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
639595|NCT02362373|O1|Outcome|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
639596|NCT02362373|E1|Reported Event|Women With Epilepsy Receiving the LNG IUS|There was one group in this pilot study. All women received the LNG IUS.
639597|NCT02362360|B1|Baseline|Overall Study Population|All subjects included in the investigation
639598|NCT02362360|P2|Participant Flow|Comparator Then Coloplast Test Product|"The subject first tests the Comparator and then tests the Coloplast Test Product.~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
639599|NCT02362360|P1|Participant Flow|Coloplast Test Product Then Comparator|"The subject first tests the Coloplast Test Product and then tests the Comparator~Coloplast Test Product: A new 2-piece ostomy appliance developed by Coloplast A/S~Comparator (Hollister): Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag."
639600|NCT02362360|O2|Outcome|Comparator|Answers from subjects testing Comparator
639601|NCT02362360|O1|Outcome|Coloplast Test Product|Answers from subjects testing Coloplast test product
639602|NCT02362360|E2|Reported Event|Comparator|Answers from subjects testing Comparator
639603|NCT02362360|E1|Reported Event|Coloplast Test Product|Answers from subjects testing Coloplast test product
639604|NCT02362321|B3|Baseline|Total|Total of all reporting groups
639605|NCT02362321|B2|Baseline|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
639606|NCT02362321|B1|Baseline|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
639607|NCT02362321|P2|Participant Flow|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
639608|NCT02362321|P1|Participant Flow|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
639609|NCT02362321|O2|Outcome|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
639610|NCT02362321|O1|Outcome|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
639611|NCT02362321|E2|Reported Event|Control|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
639612|NCT02362321|E1|Reported Event|Dexamethasone|"Participants allocated to the treatment group received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).~Dexamethasone: Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs)."
639613|NCT02361736|B3|Baseline|Total|Total of all reporting groups
639614|NCT02361736|B2|Baseline|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639615|NCT02361736|B1|Baseline|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639616|NCT02361736|P2|Participant Flow|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639617|NCT02361736|P1|Participant Flow|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639618|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639619|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639620|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639621|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639622|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639623|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639624|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639625|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639626|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639627|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639628|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639629|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639630|NCT02361736|O2|Outcome|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639631|NCT02361736|O1|Outcome|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639632|NCT02361736|E2|Reported Event|Hydroxyethyl Starch|"6% Hydroxyethyl Starch (HES) is intravenously administrated at a dose of 7.5ml/ kg in the first hour of surgery, and then, Lactate Ringers’ is administrated to the patient until the end of the surgery~Hydroxyethyl Starch: 6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery"
639633|NCT02361736|E1|Reported Event|Lactate Ringers|"Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery~Lactate Ringers: Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery"
639634|NCT02361580|B3|Baseline|Total|Total of all reporting groups
639635|NCT02361580|B2|Baseline|No Diary|Control Group
639636|NCT02361580|B1|Baseline|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
639637|NCT02361580|P2|Participant Flow|No Diary|Control Group
639749|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
639638|NCT02361580|P1|Participant Flow|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
639639|NCT02361580|O2|Outcome|No Diary|Control Group
639640|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
639641|NCT02361580|O2|Outcome|No Diary|Control Group
639642|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
639643|NCT02361580|O2|Outcome|No Diary|Control Group
639644|NCT02361580|O1|Outcome|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
639645|NCT02361580|E2|Reported Event|No Diary|Control Group
639646|NCT02361580|E1|Reported Event|Diary|"Subjects that are randomized to the diary group will be told to keep a diary of their recovery. The study is focusing on the effect of keeping a diary on disability, rather than the content of the diary.~Diary: Subject keeps diary of recovery"
639647|NCT02360995|B4|Baseline|Total|Total of all reporting groups
639648|NCT02360995|B3|Baseline|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639649|NCT02360995|B2|Baseline|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639650|NCT02360995|B1|Baseline|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639651|NCT02360995|P3|Participant Flow|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639652|NCT02360995|P2|Participant Flow|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639653|NCT02360995|P1|Participant Flow|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639654|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639655|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639656|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639657|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639658|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639659|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639660|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639661|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639662|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639700|NCT02359955|O4|Outcome|Amp Value of Left Masseter of Anatomic Teeth|
639663|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639664|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639665|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639666|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639667|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639668|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639669|NCT02360995|O3|Outcome|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639670|NCT02360995|O2|Outcome|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639671|NCT02360995|O1|Outcome|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639672|NCT02360995|E3|Reported Event|Control Group|"fluoride toothpaste +fluoride mouthwash~fluoride toothpaste + fluoride mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time."
639673|NCT02360995|E2|Reported Event|Toothpaste + Mouthwash|"Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration). Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time."
639674|NCT02360995|E1|Reported Event|Total Toothpaste|"Triclosan/fluoride toothpaste~Triclosan/fluoride toothpaste: Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration)."
639675|NCT02360124|B4|Baseline|Total|Total of all reporting groups
639676|NCT02360124|B3|Baseline|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639677|NCT02360124|B2|Baseline|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639678|NCT02360124|B1|Baseline|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
639679|NCT02360124|P3|Participant Flow|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639680|NCT02360124|P2|Participant Flow|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639701|NCT02359955|O3|Outcome|Amp Value of Right Master of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
639702|NCT02359955|O2|Outcome|Amp Value of Left Masseter of Zero Degree Teeth|
639703|NCT02359955|O1|Outcome|Amp Value of Right Masseter of Zero Degree Teeth|emg parameter of edentulous patients treated with zero-degree teeth complete denture
639681|NCT02360124|P1|Participant Flow|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
639682|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces~saturated potassium iodide solution: topical application of SDF solution followed by KI solution onto tooth root surfaces"
639683|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639684|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water as placebo with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
639685|NCT02360124|O3|Outcome|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639686|NCT02360124|O2|Outcome|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639687|NCT02360124|O1|Outcome|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
639688|NCT02360124|E3|Reported Event|Silver Diammine Fluoride and KI|"the subjects will receive the same treatment as those provided to subjects in the control group except that a 38% SDF solution instead of the placebo solution will be painted onto the exposed tooth root surfaces and followed by painting of a saturated potassium iodide solution. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639689|NCT02360124|E2|Reported Event|Silver Diammine Fluoride|"the subjects will receive the same intervention as those provided to subjects in the control group except that a 38% SDF solution (Saforide, Toyo Seiyaku Kasei Co. Ltd, Osaka, Japan) instead of the placebo solution will be painted onto the exposed tooth root surfaces. This treatment will be repeated after 12 and 24 months.~silver diammine fluoride: topical application of the SDF solution onto tooth root surfaces"
639690|NCT02360124|E1|Reported Event|Control|"instructions on oral hygiene (OHI) tailored to the individual’s condition will be given, and a tube of toothpaste containing 1,000 ppm fluoride (the most popular type of adult toothpaste in the Hong Kong market) will be provided. The OHI and provision of toothpaste will be repeated at 6-month intervals. In addition, distilled water with a bitter flavor added (to mimic the bitter metallic taste of SDF) will be painted onto all exposed tooth root surfaces using a small disposable brush. This procedure will be repeated after 12 and 24 months.~Water as placebo: topical application of water as a placebo in the control arm"
639691|NCT02359955|B3|Baseline|Total|Total of all reporting groups
639692|NCT02359955|B2|Baseline|Group 2|"edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
639693|NCT02359955|B1|Baseline|Group 1|"edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture~zero degree teeth: zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture~anatomic teeth: when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture"
639694|NCT02359955|P2|Participant Flow|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
639695|NCT02359955|P1|Participant Flow|Zero-degree Teeth, Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
639696|NCT02359955|O4|Outcome|Duration of Left Masseter of Anatomic Teeth|
639697|NCT02359955|O3|Outcome|Duration of Right Masster of Anatomic Teeth|emg parameter of patients treated with anatomic teeth complete denture
639698|NCT02359955|O2|Outcome|Duration of Left Masseter of Zero Degree Teeth|
639704|NCT02359955|O4|Outcome|Group 2 Zero Degree Teeth|
639706|NCT02359955|O2|Outcome|Group 2 Anatomic Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
639707|NCT02359955|O1|Outcome|Group 1 Zero Degree Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
639708|NCT02359955|E2|Reported Event|Anatomic Teeth, Then Zero-degree Teeth|edentulous patients who were first treated with anatomic teeth complete denture, the with zero degree teeth complete denture
639709|NCT02359955|E1|Reported Event|Zero Degree Teeth,Then Anatomic Teeth|edentulous patients who were first treated with zero-degree teeth complete denture, then with anatomic teeth complete denture
639710|NCT02359903|B3|Baseline|Total|Total of all reporting groups
639711|NCT02359903|B2|Baseline|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
639712|NCT02359903|B1|Baseline|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
639713|NCT02359903|P2|Participant Flow|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
639714|NCT02359903|P1|Participant Flow|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
639715|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
639716|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
639717|NCT02359903|O2|Outcome|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
639718|NCT02359903|O1|Outcome|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
639719|NCT02359903|E2|Reported Event|Remicade Group|"Remicade (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (Remicade)"
639720|NCT02359903|E1|Reported Event|BCD-055 Group|"BCD-055 (infliximab) at a dose of 5 mg/kg, administered as a slow intravenous infusion, which will be performed on week 0, 2, 6, 14 and 22~Infliximab (BCD-055): infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha"
639721|NCT02359877|B5|Baseline|Total|Total of all reporting groups
639722|NCT02359877|B4|Baseline|BCD-054 (Multiple Doses)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
639723|NCT02359877|B3|Baseline|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
639724|NCT02359877|B2|Baseline|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
639725|NCT02359877|B1|Baseline|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
639726|NCT02359877|P4|Participant Flow|BCD-054 (Multiple Dose)|Pegylated interferon beta 1a (BCD-054) Multiple dose - 180 mcg, IM/SC, biweekly, 3 injections
639727|NCT02359877|P3|Participant Flow|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
639728|NCT02359877|P2|Participant Flow|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
639729|NCT02359877|P1|Participant Flow|BCD-054 (Single Doses)|Pegylated interferon beta 1a (BCD-054) Single doses - 60 mcg, IM/SC; or 120 mcg, IM/SC; or 240 mcg, IM/SC; or 360 mcg, IM/SC
639730|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
639731|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
639732|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
639733|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
639734|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
639735|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
639736|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
639737|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
639738|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
639739|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
639740|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
639741|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
639742|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
639743|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
639744|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
639745|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
639746|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
639747|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
639748|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
639750|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
639751|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
639752|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
639753|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
639754|NCT02359877|O2|Outcome|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054)
639755|NCT02359877|O1|Outcome|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054)
639756|NCT02359877|O10|Outcome|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
639757|NCT02359877|O9|Outcome|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
639758|NCT02359877|O8|Outcome|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
639759|NCT02359877|O7|Outcome|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
639760|NCT02359877|O6|Outcome|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
639761|NCT02359877|O5|Outcome|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
639762|NCT02359877|O4|Outcome|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
639763|NCT02359877|O3|Outcome|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
639764|NCT02359877|O2|Outcome|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
639765|NCT02359877|O1|Outcome|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
639766|NCT02359877|E12|Reported Event|BCD-054 - 180 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, intramuscular injection
639767|NCT02359877|E11|Reported Event|BCD-054 - 180 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 180 mcg, subcutaneously
639768|NCT02359877|E10|Reported Event|Avonex|interferon beta 1a (Avonex) 30 mcg, IM, once a week for 2 weeks
639769|NCT02359877|E9|Reported Event|Rebif|interferon beta 1a (Rebif) 44 mcg, SC, 3 times a week for 2 weeks
639770|NCT02359877|E8|Reported Event|BCD-054 - 360 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, intramuscular injection
639771|NCT02359877|E7|Reported Event|BCD-054 - 360 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 360 mcg, subcutaneously
639772|NCT02359877|E6|Reported Event|BCD-054 - 240 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, intramuscular injection
639773|NCT02359877|E5|Reported Event|BCD-054 - 240 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 240 mcg, subcutaneously
639774|NCT02359877|E4|Reported Event|BCD-054 - 120 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, intramuscular injection
639775|NCT02359877|E3|Reported Event|BCD-054 - 120 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 120 mcg, subcutaneously
639776|NCT02359877|E2|Reported Event|BCD-054 - 60 mcg - IM|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, intramuscular injection
639777|NCT02359877|E1|Reported Event|BCD-054 - 60 mcg - SC|Pegylated interferon beta 1a (BCD-054) Single dose - 60 mcg, subcutaneously
639778|NCT02359435|B3|Baseline|Total|Total of all reporting groups
639779|NCT02359435|B2|Baseline|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
639780|NCT02359435|B1|Baseline|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
639781|NCT02359435|P2|Participant Flow|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
639782|NCT02359435|P1|Participant Flow|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
639783|NCT02359435|O2|Outcome|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
639784|NCT02359435|O1|Outcome|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
639785|NCT02359435|E2|Reported Event|Standard Triple Therapy|"pantoprazole 40 mg, clarithromycin 500 mg, and amoxicillin 1 g for 12 days; with all drugs given twice daily~Standard triple therapy: pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days"
639786|NCT02359435|E1|Reported Event|Reverse Hybrid Therapy|"pantoprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg for the first 7 days, followed by pantoprazole 40 mg and amoxicillin 1 g for another 5 days; with all drugs given twice daily~Reverse hybrid therapy: pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days"
639787|NCT02359045|B3|Baseline|Total|Total of all reporting groups
639859|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639788|NCT02359045|B2|Baseline|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.~A-D1400147, B- D14000136 or D14000137 & C- Epanova."
639789|NCT02359045|B1|Baseline|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.~A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
639790|NCT02359045|P2|Participant Flow|Part 2|"Subjects received a single dose of 3 treatments for 3 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the two different prototype capsule formulations (Treatment A, B) in relation to Epanova capsules (Treatment C), under fed conditions.~A-D1400147, B- D14000136 or D14000137 & C- Epanova."
639791|NCT02359045|P1|Participant Flow|Part 1|"Subjects received a single dose of 4 treatments for 4 periods to assess the relative bioavailability and to characterize and compare the PK profiles of the three different prototype capsule formulations (Treatment A, B, C) in relation to Epanova capsules (Treatment D), under fasted conditions.~A- D1400147, B- D14000136, C- D14000137 & D- Epanova."
639792|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639793|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639794|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639795|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639796|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639797|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639798|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639799|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639800|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639801|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639802|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639803|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639804|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639805|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639806|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639807|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639808|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639809|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639810|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639811|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639812|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639813|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639814|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639815|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639816|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639817|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639818|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639819|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639820|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639858|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639821|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639822|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639823|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639824|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639825|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639826|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639827|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639828|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639829|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639830|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639831|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639832|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639833|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639834|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639835|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639836|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639837|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639838|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639839|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639840|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639841|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639842|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639843|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639844|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639845|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639846|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639847|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639848|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639849|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639850|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639851|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639852|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639853|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639854|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639855|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639856|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639857|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639860|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639861|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639862|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639863|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639864|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639865|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639866|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639867|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639868|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639869|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639870|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639871|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639872|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639873|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639874|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639875|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639876|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639877|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639878|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639879|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639880|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639881|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639882|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639883|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639884|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639885|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639886|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639887|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639888|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639889|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639890|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639891|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639892|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639893|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639894|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639895|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
640294|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
639896|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639897|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639898|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639899|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639900|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639901|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639902|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639903|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639904|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639905|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639906|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639907|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639908|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639909|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639910|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639911|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639912|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639913|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639914|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639915|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639916|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639917|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639918|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639919|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639920|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639921|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639922|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639923|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639924|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639925|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639926|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639927|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639928|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639929|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639930|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639931|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639932|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639970|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639971|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639933|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639934|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639935|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639936|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639937|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639938|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639939|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639940|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639941|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639942|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639943|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639944|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639945|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639946|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639947|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639948|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639949|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639950|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639951|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639952|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639953|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639954|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639955|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639956|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639957|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639958|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639959|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639960|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639961|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639962|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639963|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639964|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639965|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639966|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639967|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639968|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639969|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639972|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639973|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639974|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639975|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639976|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639977|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639978|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639979|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639980|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639981|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639982|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639983|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639984|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639985|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639986|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639987|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639988|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639989|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639990|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639991|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639992|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
639993|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
639994|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
639995|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
639996|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
639997|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
639998|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
639999|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
640000|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
640001|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
640002|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
640003|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
640004|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
640005|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
640006|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
640007|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
640295|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640008|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
640009|NCT02359045|O7|Outcome|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
640010|NCT02359045|O6|Outcome|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
640011|NCT02359045|O5|Outcome|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
640012|NCT02359045|O4|Outcome|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
640013|NCT02359045|O3|Outcome|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
640014|NCT02359045|O2|Outcome|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
640015|NCT02359045|O1|Outcome|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
640016|NCT02359045|E7|Reported Event|Treatment C_Part 2|Subjects received a single dose of Treatment C (Epanova capsules 1000 mg) under fed conditions.
640017|NCT02359045|E6|Reported Event|Treatment B_Part 2|Subjects received a single dose of Treatment B as D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1 or D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2, under fed conditions.
640018|NCT02359045|E5|Reported Event|Treatment A_Part 2|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fed conditions.
640019|NCT02359045|E4|Reported Event|Treatment D_Part 1|Subjects received a single dose of Treatment D (Epanova capsules 1000 mg) under fasted conditions.
640020|NCT02359045|E3|Reported Event|Treatment C_Part 1|Subjects received a single dose of Treatment C (D14000137: Omega-3-carboxylic acids 2000 mg coated capsules coat 2) under fasted conditions.
640021|NCT02359045|E2|Reported Event|Treatment B_Part 1|Subjects received a single dose of Treatment B (D14000136: Omega-3-carboxylic acids 2000 mg coated capsules coat 1) under fasted condition.
640022|NCT02359045|E1|Reported Event|Treatment A_Part 1|Subjects received a single dose of Treatment A (D1400147: Omega-3-carboxylic acids 2000 mg uncoated capsules) under fasted condition.
640023|NCT02358876|B1|Baseline|Participants|
640024|NCT02358876|P1|Participant Flow|Participants|
640025|NCT02358876|O1|Outcome|Participants|
640026|NCT02358876|E1|Reported Event|Participants|
640027|NCT02358668|B4|Baseline|Total|Total of all reporting groups
640028|NCT02358668|B3|Baseline|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640029|NCT02358668|B2|Baseline|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640030|NCT02358668|B1|Baseline|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640031|NCT02358668|P3|Participant Flow|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640032|NCT02358668|P2|Participant Flow|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640033|NCT02358668|P1|Participant Flow|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640034|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640035|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640036|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640037|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640038|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640039|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640040|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640041|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640042|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640043|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640297|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640044|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640045|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640046|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640047|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640048|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640049|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640050|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640051|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640052|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640053|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640054|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640055|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640056|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640057|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640058|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640059|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640060|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640061|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640062|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640063|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640064|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640065|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640066|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640067|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640068|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640069|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640070|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640296|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640298|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640071|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640072|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640073|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640074|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640075|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640076|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640077|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640078|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640079|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640080|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640081|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640082|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640083|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640084|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640085|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640086|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640087|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640088|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640089|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640090|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640091|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640092|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640093|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640094|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640095|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640096|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640097|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640181|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640098|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640099|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640100|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640101|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640102|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640103|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640104|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640105|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640106|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640107|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640108|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640109|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640110|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640111|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640112|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640113|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640114|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640115|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640116|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640117|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640118|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640119|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640120|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640121|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640122|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640123|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640124|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640182|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640125|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640126|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640127|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640128|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640129|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640130|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640131|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640132|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640133|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640134|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640135|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640136|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640137|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640138|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640139|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640140|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640141|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640142|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640143|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640144|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640145|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640146|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640147|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640148|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640149|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640150|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640151|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640183|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640152|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640153|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640154|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640155|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640156|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640157|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640158|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640159|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640160|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640161|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640162|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640163|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640164|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640165|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640166|NCT02358668|O3|Outcome|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640167|NCT02358668|O2|Outcome|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640168|NCT02358668|O1|Outcome|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640169|NCT02358668|E3|Reported Event|BTI320 Matching Placebo|"2 tablets three times daily, oral for 16 weeks~BTI320 matching placebo: Placebo"
640170|NCT02358668|E2|Reported Event|BTI320 8 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640171|NCT02358668|E1|Reported Event|BTI320 4 Grams|"three times daily, oral for 16 weeks~BTI320: BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar."
640172|NCT02358044|B3|Baseline|Total|Total of all reporting groups
640173|NCT02358044|B2|Baseline|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640174|NCT02358044|B1|Baseline|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640175|NCT02358044|P2|Participant Flow|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640176|NCT02358044|P1|Participant Flow|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640177|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640178|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640179|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640180|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640255|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640184|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640185|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640186|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640187|NCT02358044|O2|Outcome|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640188|NCT02358044|O1|Outcome|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640189|NCT02358044|E2|Reported Event|SOF + PR|Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
640190|NCT02358044|E1|Reported Event|Grazoprevir + Elbasvir|Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up.
640191|NCT02357940|B3|Baseline|Total|Total of all reporting groups
640192|NCT02357940|B2|Baseline|Babies|Babies - 1% Colloidal Oatmeal Balm
640193|NCT02357940|B1|Baseline|Adults|Adults - 1% Colloidal Oatmeal Balm
640194|NCT02357940|P2|Participant Flow|Babies|Babies - 1% Colloidal Oatmeal Balm
640195|NCT02357940|P1|Participant Flow|Adults|Adults - 1% Colloidal Oatmeal Balm
640196|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640197|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640198|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640199|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640200|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640201|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640202|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640203|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640204|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640205|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640206|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640207|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640208|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640209|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640210|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640211|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640212|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640213|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640214|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640215|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640216|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640217|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640218|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640219|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640220|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640221|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640222|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640223|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640224|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640225|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640226|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640227|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640228|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640229|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640230|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640231|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640232|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640233|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640234|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640235|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640236|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640237|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640238|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640239|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640240|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640241|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640242|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640243|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640244|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640245|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640246|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640247|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640248|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640249|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640250|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640251|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640252|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640253|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640254|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640301|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640302|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640303|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640304|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640305|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640306|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640307|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640308|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640309|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640310|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640311|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640312|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640313|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640314|NCT02357940|O2|Outcome|Babies|Babies - 1% Colloidal Oatmeal Balm
640315|NCT02357940|O1|Outcome|Adults|Adults - 1% Colloidal Oatmeal Balm
640316|NCT02357940|E2|Reported Event|Babies|Babies - 1% Colloidal Oatmeal Balm
640317|NCT02357940|E1|Reported Event|Adults|Adults - 1% Colloidal Oatmeal Balm
640318|NCT02357485|B1|Baseline|Treatment Arm|Single injection of ADSC
640319|NCT02357485|P1|Participant Flow|Treatment Arm|Single injection of Adipose-derived Stromal Cells (ADSC) into intra-articular space of the knee
640320|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
640321|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
640322|NCT02357485|O1|Outcome|Treatment Arm|"Single injection of ADSC~ADSC: Single injection of ADSC"
640323|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
640324|NCT02357485|O1|Outcome|Treatment Arm|Single injection of ADSC
640325|NCT02357485|E1|Reported Event|Treatment Arm|Single injection of ADSC
640339|NCT02357264|B3|Baseline|Total|Total of all reporting groups
640340|NCT02357264|B2|Baseline|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
640341|NCT02357264|B1|Baseline|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
640342|NCT02357264|P2|Participant Flow|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
640343|NCT02357264|P1|Participant Flow|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
640344|NCT02357264|O2|Outcome|Pregnant Females With Suspicion of Pre-eclampsia|Pregnant females who the OB/GYN physician has suspicion that may have pre-eclampsia
640345|NCT02357264|O1|Outcome|Pregnant Females Without Pre-Eclampsia|Pregnant Females who the OB/GYN physician suspects do not have pre-eclampsia
640346|NCT02357264|E2|Reported Event|No Pre-eclampsia.|"Ultrasound of Pregnant Females 18+ with no pre-eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
640347|NCT02357264|E1|Reported Event|Pre-eclampsia|"Ultrasound of Pregnant Females 18+ with pre-Eclampsia~Ultrasound: Ultrasound of the chest for the detection of fluid in the lung"
640348|NCT02356900|B3|Baseline|Total|Total of all reporting groups
640349|NCT02356900|B2|Baseline|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640350|NCT02356900|B1|Baseline|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640351|NCT02356900|P2|Participant Flow|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640352|NCT02356900|P1|Participant Flow|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640353|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640354|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640355|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640356|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
641376|NCT02338336|E1|Reported Event|Placebo|Matching Placebo
640357|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640358|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640359|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640360|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640361|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640362|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640363|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640364|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640365|NCT02356900|O2|Outcome|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
641520|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
640366|NCT02356900|O1|Outcome|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640367|NCT02356900|E2|Reported Event|Normoxic, Normobaric|"Normoxic, normobaric, interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis.~Normoxic, normobaric, interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week."
640368|NCT02356900|E1|Reported Event|Hyperoxic, Hyperbaric|"Hyperoxic hyperbaric interval exercise training Six sessions of 30 min.of High-intensity interval training completed on a 3-times a week basis at 1.4 ATA of oxygen in a hyperbaric chamber.~Hyperoxic hyperbaric interval exercise training: Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.~Oxygen: Used in Hyperoxic hyperbaric interval exercise training intervention"
640369|NCT02356588|B3|Baseline|Total|Total of all reporting groups
640370|NCT02356588|B2|Baseline|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640371|NCT02356588|B1|Baseline|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640372|NCT02356588|P2|Participant Flow|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640373|NCT02356588|P1|Participant Flow|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640426|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
640374|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640375|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640376|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640377|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640378|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640379|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640380|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640414|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
641521|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
640381|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640382|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640383|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640384|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640385|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640386|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640427|NCT02355275|E1|Reported Event|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
640428|NCT02354924|B3|Baseline|Total|Total of all reporting groups
640387|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640388|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640389|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640390|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640391|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640392|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640393|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640394|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640442|NCT02354833|B2|Baseline|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
644208|NCT02307838|B4|Baseline|Total|Total of all reporting groups
640395|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640396|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640397|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640398|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640399|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640400|NCT02356588|O2|Outcome|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640401|NCT02356588|O1|Outcome|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640402|NCT02356588|E2|Reported Event|Placebo Tablet|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Placebo Tablet"
640403|NCT02356588|E1|Reported Event|Sufentanil Tablet 30 mcg|"A stratified randomization will be applied in this study with sex as a stratification factor. Patients who meet all inclusion and none of the exclusion criteria at screening, and following surgery, will be randomly assigned at a 2:1 ratio to treatment with ST 30 mcg or PT within one of two groups (male or female) at each study center. Patients may receive a dose of study medication no more frequently than once per hour. The study may last up to 48 hours.~Sufentanil Tablet 30 mcg"
640404|NCT02355977|B4|Baseline|Total|Total of all reporting groups
640405|NCT02355977|B3|Baseline|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
640406|NCT02355977|B2|Baseline|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
640407|NCT02355977|B1|Baseline|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
640408|NCT02355977|P3|Participant Flow|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
640409|NCT02355977|P2|Participant Flow|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
640410|NCT02355977|P1|Participant Flow|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
640411|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
640412|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
640413|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
640443|NCT02354833|B1|Baseline|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
640415|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
640416|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
640417|NCT02355977|O3|Outcome|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
640418|NCT02355977|O2|Outcome|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
640419|NCT02355977|O1|Outcome|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
640420|NCT02355977|E3|Reported Event|Surface and Root Planning+Minocycline|"surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.~minocycline: Periocline dental ointment"
640421|NCT02355977|E2|Reported Event|Locally Delivered Minocycline|"Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth~minocycline: Periocline dental ointment~surface and root planning: surface and root planning"
640422|NCT02355977|E1|Reported Event|Surface and Root Planning|"surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France)~surface and root planning: surface and root planning"
640423|NCT02355275|B1|Baseline|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
640424|NCT02355275|P1|Participant Flow|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
640425|NCT02355275|O1|Outcome|Home Exercise Program|Home Exercise Program: All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
640467|NCT02354599|P2|Participant Flow|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640429|NCT02354924|B2|Baseline|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640430|NCT02354924|B1|Baseline|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640431|NCT02354924|P2|Participant Flow|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640432|NCT02354924|P1|Participant Flow|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640433|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640434|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640435|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640436|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640437|NCT02354924|O2|Outcome|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640438|NCT02354924|O1|Outcome|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens or one of the study lenses on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640439|NCT02354924|E2|Reported Event|Biofinity Soft Contact Lens|"Comfilcon A, Daily wear, monthly disposable soft contact lens~Biofinity soft contact lens: Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640440|NCT02354924|E1|Reported Event|Visco Soft Contact Lens|"Olifilcon A, Daily wear, monthly disposable soft contact lens~Visco soft contact lens: Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days."
640441|NCT02354833|B3|Baseline|Total|Total of all reporting groups
640444|NCT02354833|P2|Participant Flow|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
640445|NCT02354833|P1|Participant Flow|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
640446|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
640447|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
640448|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
640449|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
640450|NCT02354833|O2|Outcome|Norepinephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
640451|NCT02354833|O1|Outcome|Phenylephrine|Cardiac Output as recorded by a non-invasive hemodynamic monitor
640452|NCT02354833|O2|Outcome|Norepinephrine|"A continuous norepinephrine infusion at 0.05 mcg/kg/min~Norepinephrine"
640453|NCT02354833|O1|Outcome|Phenylephrine|"A continuous phenylephrine infusion at 0.1 mcg/kg/min~Phenylephrine"
640454|NCT02354833|E2|Reported Event|Norepinephrine|Hypotension requiring a rescue bolus
640455|NCT02354833|E1|Reported Event|Phenylephrine|Hypotension requiring a rescue bolus
640456|NCT02354599|B7|Baseline|Total|Total of all reporting groups
640457|NCT02354599|B6|Baseline|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640458|NCT02354599|B5|Baseline|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640459|NCT02354599|B4|Baseline|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640460|NCT02354599|B3|Baseline|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640461|NCT02354599|B2|Baseline|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640462|NCT02354599|B1|Baseline|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640463|NCT02354599|P6|Participant Flow|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640464|NCT02354599|P5|Participant Flow|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640465|NCT02354599|P4|Participant Flow|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640466|NCT02354599|P3|Participant Flow|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640468|NCT02354599|P1|Participant Flow|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640469|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640470|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640471|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640472|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640473|NCT02354599|O6|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640474|NCT02354599|O5|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640475|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640476|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640477|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640478|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640479|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640480|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640481|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640482|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640483|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640484|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640485|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640486|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640487|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640488|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640489|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640490|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640491|NCT02354599|O4|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640492|NCT02354599|O3|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640493|NCT02354599|O2|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640494|NCT02354599|O1|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640495|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640496|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640497|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640498|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640499|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640500|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640501|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640502|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640503|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640504|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640505|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640506|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640507|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640508|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640509|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640510|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640511|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640512|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640513|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640514|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640515|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640516|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640517|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640518|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640519|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640520|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640521|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640522|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640523|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640524|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640525|NCT02354599|O6|Outcome|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640526|NCT02354599|O5|Outcome|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640527|NCT02354599|O4|Outcome|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640528|NCT02354599|O3|Outcome|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640529|NCT02354599|O2|Outcome|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640530|NCT02354599|O1|Outcome|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640531|NCT02354599|E6|Reported Event|Cohort 4: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640532|NCT02354599|E5|Reported Event|Cohort 4: Placebo|MT203 placebo-matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Caucasian participants.
640533|NCT02354599|E4|Reported Event|Cohort 3: MT203 300 mg|MT203 300 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640534|NCT02354599|E3|Reported Event|Cohort 2: MT203 150 mg|MT203 150 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640535|NCT02354599|E2|Reported Event|Cohort 1: MT203 80 mg|MT203 80 mg, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640536|NCT02354599|E1|Reported Event|Cohort 1-3: Placebo|MT203 placebo -matching, injection, subcutaneously, once on Day 1 in the 15 days treatment period in Japanese participants.
640537|NCT02353754|B3|Baseline|Total|Total of all reporting groups
640538|NCT02353754|B2|Baseline|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
640539|NCT02353754|B1|Baseline|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
640540|NCT02353754|P2|Participant Flow|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
640541|NCT02353754|P1|Participant Flow|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
640542|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
640543|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
640544|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
640580|NCT02351817|B1|Baseline|Overall Study Population|The investigation is a cross-over investigation therefore baseline data is presented for the overall population
640545|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
640546|NCT02353754|O2|Outcome|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
640547|NCT02353754|O1|Outcome|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
640548|NCT02353754|E2|Reported Event|EXPAREL/TAP|"Subjects in Group 2 will receive a bilateral TAP infiltration with a single 20 mL dose of EXPAREL 266 mg expanded in volume with 20 mL of normal saline for a total volume of 40 mL (20 mL infiltrated on each side of the abdomen).~EXPAREL: 266 mg"
640549|NCT02353754|E1|Reported Event|Standard of Care|"Subjects in Group 1 (Standard of Care) will receive intrathecal morphine injection (e.g., Duramorph®) 0.2 mg in conjunction with the single-shot spinal anesthesia. No TAP block will be administered.~Intrathecal morphine injection: 0.2 mg"
640550|NCT02353572|B1|Baseline|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
640551|NCT02353572|P1|Participant Flow|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
640552|NCT02353572|O1|Outcome|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
640553|NCT02353572|E1|Reported Event|Melphalan, Bortezomib, Autologous Transplant|Patients received melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also received dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients underwent autologous hematopoietic stem cell transplant.
640554|NCT02353468|B1|Baseline|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
645262|NCT02290821|B3|Baseline|Total|Total of all reporting groups
640555|NCT02353468|P1|Participant Flow|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
640556|NCT02353468|O1|Outcome|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
640557|NCT02353468|E1|Reported Event|Enzyme Inhibitor, Biological Therapy, Chemotherapy|"CONSOLIDATION: Patients received VLD therapy comprising bortezomib IV on days 1, 4, 8, and 11, lenalidomide PO QD on days 1-14, and dexamethasone PO or IV on days 1, 2, 4, 5, 8, 9, 11, and 12. Courses continue for 28 days and repeat every 3 months in the absence of disease progression or unacceptable toxicity.~In between courses of VLD, patients received LD therapy comprising lenalidomide PO QD on days 1-21 and dexamethasone PO QD or IV every Monday (x3). Courses continue for 28 days.~MAINTENANCE: Starting in the third year of therapy, patients received lenalidomide PO QD on days 1-14 and dexamethasone PO QD or IV every Monday (x2). Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Lenalidomide: Given PO~Dexamethasone: Given PO or IV"
640558|NCT02353442|B3|Baseline|Total|Total of all reporting groups
640559|NCT02353442|B2|Baseline|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640560|NCT02353442|B1|Baseline|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640561|NCT02353442|P2|Participant Flow|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640562|NCT02353442|P1|Participant Flow|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640563|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640564|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640565|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640566|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640567|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640568|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640569|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640601|NCT02350881|O2|Outcome|Revisions|Percentage of feet reoperated for implant ablation
640602|NCT02350881|O1|Outcome|Survival|Percentage of feet with implant still in place
640603|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain at rest postoperatively
640570|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640571|NCT02353442|O2|Outcome|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640572|NCT02353442|O1|Outcome|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640573|NCT02353442|E2|Reported Event|Experimental Group|"This group will perform during 4 weeks:~posterior shoulder mobilizations during 5min (mobilizations during 30s and 30s of rest);~external rotators strengthening in sidelying positions with load (3x10repetitions);~posterior capsule stretching (sleeper stretch in sidelying position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640574|NCT02353442|E1|Reported Event|Control Group|"This group will perform during 4 weeks:~placebo ultrasound during 5min ;~scapular squeezing in the sitting position (3x10repetitions);~upper trapezius stretching (in sitting position, 3x30s and 30s of rest).~Posterior shoulder mobilizations: The subjects will be randomized to Experimental or control group."
640575|NCT02352298|B1|Baseline|Dario and Yellow Springs Instrument|Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System and the Yellow Springs Instrument for comparison.
640576|NCT02352298|P1|Participant Flow|Dario and Yellow Springs Instrument|Blood is obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System, blood glucose level is then also analyzed on the Yellow Springs Instrument for comparison.
640577|NCT02352298|O1|Outcome|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System~Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
640578|NCT02352298|E2|Reported Event|YSI STAT|"Blood obtained via fingerstick and blood glucose level is tested on the YSI STAT for comparison to the results obtained with the Dario Blood Glucose Monitoring System~YSI Analyzer: Fingerstick to obtain blood sample for analysis with YSI"
640579|NCT02352298|E1|Reported Event|Dario Blood Glucose Monitoring System|"Blood obtained via fingerstick and blood glucose level is tested on the Dario Blood Glucose Monitoring System~Dario Blood Glucose Monitoring System: Fingerstick to obtain blood sample for analysis with the Dario BGMS"
640581|NCT02351817|P2|Participant Flow|Baseline - Test B - Test A|"First each subject tests baseline product, then Test B and finally Test A.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
640582|NCT02351817|P1|Participant Flow|Baseline - Test A - Test B|"First each subject tests baseline product, then Test A and finally Test B.~Baseline product: the subject's usual product~Test A: A newly developed 1-piece, open ostomy appliance for collecting feces~Test B: A newly developed 1-piece, open ostomy appliance for collecting feces"
640583|NCT02351817|O2|Outcome|Test B|How many subjects preferred Test B over own product
640584|NCT02351817|O1|Outcome|Test A|How many subjects preferred Test A over own product
640585|NCT02351817|E3|Reported Event|Test B|Adverse events reported by subjects testing Test B
640586|NCT02351817|E2|Reported Event|Test A|Adverse events reported by subjects testing Test A
640587|NCT02351817|E1|Reported Event|Baseline|Adverse events reported by subjects testing Own product
640588|NCT02351505|B1|Baseline|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640589|NCT02351505|P1|Participant Flow|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
640590|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640591|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640592|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640593|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640594|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640595|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640596|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640597|NCT02351505|O1|Outcome|Arm A: Selinexor (KPT-330)|"Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Pharmacological Study: Correlative studies"
640598|NCT02351505|E1|Reported Event|Arm A: Selinexor (KPT-330)|Patients receive selinexor PO twice weekly. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
640599|NCT02350881|B1|Baseline|Overall Cohort|one consecutive series of patients were included
640600|NCT02350881|P1|Participant Flow|Overall Cohort|one consecutive series of patients were included
640604|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain at rest postoperatively
640605|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain at rest postoperatively
640606|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain at rest postoperatively
640607|NCT02350881|O4|Outcome|Greater|Number of patients who declared a worsening of pain during walking postoperatively
640608|NCT02350881|O3|Outcome|Same|Number of patients who declared no improvement in pain during walking postoperatively
640609|NCT02350881|O2|Outcome|Less|Number of patients who declared a slight improvement of pain during walking postoperatively
640610|NCT02350881|O1|Outcome|Disappeared|Number of patients who declared an absence of pain during walking postoperatively
640611|NCT02350881|O3|Outcome|Worsened|Number of patients who declared a worsening of their walking perimeter
640612|NCT02350881|O2|Outcome|Same|Number of patients who declared no improvement in their walking perimeter
640613|NCT02350881|O1|Outcome|Improved|Number of patients who declared an improvement in their walking perimeter
640614|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
640615|NCT02350881|O2|Outcome|Moderate|umber of patients reporting a moderate pain
640616|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
640617|NCT02350881|O2|Outcome|Presence|Number of feet where bone resorption was observed
640618|NCT02350881|O1|Outcome|Absence|Number of feet where no bone resorption was observed
640619|NCT02350881|O2|Outcome|Presence|Number of feet where osteolysis was observed
640620|NCT02350881|O1|Outcome|Absence|Number of feet where no osteolysis was observed
640621|NCT02350881|O3|Outcome|Severe|Number of patients reporting a severe pain
640622|NCT02350881|O2|Outcome|Moderate|Number of patients reporting a moderate pain
640623|NCT02350881|O1|Outcome|Absent|Number of patients reporting no pain
640624|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
640625|NCT02350881|O1|Outcome|Overall Cohort|one consecutive series of patients were included
640626|NCT02350881|E1|Reported Event|Overall Cohort|one consecutive series of patients were included
640627|NCT02350569|B1|Baseline|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
640649|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
640696|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640628|NCT02350569|P1|Participant Flow|LDV/SOF|"LDV/SOF for 1 Day: 3 participants were called for transplant, received one dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg), but had their liver transplant cancelled. All 3 participants were rescreened and 2 were subsequently re-enrolled, transplanted, and continued into the Main Study.~Main Study (LDV/SOF 4 Weeks): One dose of ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 hepatitis C virus (HCV) infection.~Retreatment (LDV/SOF 12 Weeks): Participants who completed treatment in the Main Study and experienced virologic failure had the option to be retreated with LDV/SOF for 12 weeks."
640629|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
640630|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
640631|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
640632|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
640633|NCT02350569|O1|Outcome|Main Study (LDV/SOF 4 Weeks)|One dose of LDV/SOF (90/400 mg) immediately prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant in participants with chronic genotype 1 HCV infection
640634|NCT02350569|E3|Reported Event|Retreatment (LDV/SOF 12 Weeks)|Adverse events reported in this group include 1 participant who completed treatment and experienced virologic failure in the Main Study and was retreated with an additional 12 weeks of LDV/SOF.
640635|NCT02350569|E2|Reported Event|Main Study (LDV/SOF 4 Weeks)|Adverse events reported in this group include participants with chronic genotype 1 HCV infection who received one dose of LDV/SOF (90/400 mg) prior to receiving a liver transplant, followed by LDV/SOF (90/400 mg) once daily for 4 weeks following transplant.
640636|NCT02350569|E1|Reported Event|LDV/SOF for 1 Day|Adverse events reported in this group include participants who received LDV/SOF on Day -1, but did not receive a liver transplant. All 3 participants were rescreened, but only 2 were re-enrolled, transplanted, and received LDV/SOF for 4 weeks.
640637|NCT02349711|B3|Baseline|Total|Total of all reporting groups
640638|NCT02349711|B2|Baseline|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
640639|NCT02349711|B1|Baseline|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
640640|NCT02349711|P2|Participant Flow|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
640714|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640641|NCT02349711|P1|Participant Flow|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
640642|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
640643|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
640644|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
640645|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
640646|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
640647|NCT02349711|O1|Outcome|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
640648|NCT02349711|O2|Outcome|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
640733|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640650|NCT02349711|E2|Reported Event|Probiotic Mixture|A 350 mg capsule containing a commercially available probiotic mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Inactive ingredients included gelatin, potato starch, and silica.
640651|NCT02349711|E1|Reported Event|Placebo|Placebo was to be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group was unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
640652|NCT02349685|B4|Baseline|Total|Total of all reporting groups
640653|NCT02349685|B3|Baseline|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
640654|NCT02349685|B2|Baseline|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
640655|NCT02349685|B1|Baseline|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
640656|NCT02349685|P3|Participant Flow|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
640657|NCT02349685|P2|Participant Flow|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
640658|NCT02349685|P1|Participant Flow|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
640659|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.~H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
640660|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
640715|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640661|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
640662|NCT02349685|O3|Outcome|14 Day Tailored Therapy Group|"based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.~H. pylori culture and antimicrobial susceptibility test: Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute."
640663|NCT02349685|O2|Outcome|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
640664|NCT02349685|O1|Outcome|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
640665|NCT02349685|E3|Reported Event|14 Day Tailored Therapy Group|based on H. pylori culture and MIC, select the 2nd rescue regimen between 14 days of bismuth-based quadruple therapy or 14 days moxifloxacin-containing triple therapy according to antibiotics susceptibility.
640666|NCT02349685|E2|Reported Event|14 Day MEA Group|"PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.~14 day MEA group: Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)"
640830|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640831|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640667|NCT02349685|E1|Reported Event|14 Day PBMT Group|"Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d~14 day PBMT group: Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]"
640668|NCT02349438|B1|Baseline|Dispensed|All subjects that were dispensed at least 1 study lens during the course of the study.
640669|NCT02349438|P2|Participant Flow|Lotrafilcon B/Senofilcon A|Subjects that were randomized to receive the lotrafilcon B lens first and then to receive the senofilcon A lens.
640670|NCT02349438|P1|Participant Flow|Senofilcon A/Lotrafilcon B|Subjects that were randomized to receive the senofilcon A lens first and then to receive the lotrafilcon B lens.
640671|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
640672|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
640673|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
640674|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
640675|NCT02349438|O2|Outcome|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
640676|NCT02349438|O1|Outcome|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
640677|NCT02349438|E2|Reported Event|Lotrafilcon B|Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
640678|NCT02349438|E1|Reported Event|Senofilcon A|Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
640679|NCT02349048|B3|Baseline|Total|Total of all reporting groups
640680|NCT02349048|B2|Baseline|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640681|NCT02349048|B1|Baseline|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640682|NCT02349048|P2|Participant Flow|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640683|NCT02349048|P1|Participant Flow|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640684|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640685|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640686|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
645263|NCT02290821|B2|Baseline|Placebo|"Placebo~diclofenac sodium gel 1%"
640687|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640688|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640689|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640690|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640691|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640692|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640693|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640694|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640695|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640832|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640697|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640698|NCT02349048|O2|Outcome|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640699|NCT02349048|O1|Outcome|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640700|NCT02349048|E2|Reported Event|Arm B: Simeprevir/Daclatasvir/Sofosbuvir - 8 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with compensated cirrhosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 8 weeks.
640701|NCT02349048|E1|Reported Event|Arm A: Simeprevir/Daclatasvir/Sofosbuvir - 6 Weeks|Chronic hepatitis C virus (HCV) genotype 1 infected participants with early stages of liver fibrosis received therapy (Simeprevir [SMV] 150 milligram (mg)/Daclatasvir [DCV] 60mg/Sofosbuvir [SOF] 400mg) once daily for 6 weeks.
640702|NCT02348658|B1|Baseline|All Participants|All participants who received either 1 of the two treatment sequences: Sequence 1: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2 or Sequence 2: TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
640703|NCT02348658|P2|Participant Flow|TAK-536TCH Fed + TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 2.
640704|NCT02348658|P1|Participant Flow|TAK-536TCH Fasted + TAK-536TCH Fed|TAK-536TCH (20 milligram [mg]/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in Period 1, followed by 22 days washout period, followed by TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in Period 2.
640705|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640706|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640707|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640708|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640709|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640710|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640711|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640712|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640713|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640716|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640717|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640718|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640719|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640720|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640721|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640722|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640723|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640724|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640725|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640726|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640727|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640728|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640729|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640730|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640731|NCT02348658|O2|Outcome|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640732|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640833|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640734|NCT02348658|O1|Outcome|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640735|NCT02348658|E2|Reported Event|TAK-536TCH Fed|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fed condition, orally, once on Day 1 in either Period 1 or Period 2.
640736|NCT02348658|E1|Reported Event|TAK-536TCH Fasted|TAK-536TCH (20 mg/5 mg/12.5 mg), tablet, in fasted condition, orally, once on Day 1 in either Period 1 or Period 2.
640737|NCT02347488|B1|Baseline|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
640738|NCT02347488|P1|Participant Flow|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
640739|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
640740|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
640741|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
640742|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
640743|NCT02347488|O1|Outcome|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery."
640744|NCT02347488|O2|Outcome|Haider ETT Tube Holder|Following the traction test and measurement of taped ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
640745|NCT02347488|O1|Outcome|Adhesive Tape|Participants had endotracheal tubes secured with tape prior to having surgery, which is the current standard of care. Following the traction test and measurement of ETT tip position displacement, endotracheal tubes were re-secured with a combined Haider ETT Tube Holder and Bite Guard.
640793|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640794|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640795|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640746|NCT02347488|E1|Reported Event|Tape, Followed by ETT Holder and Bite Guard|"Tape: Surgery patients had endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.~Haider ETT Tube Holder and Bite Guard: Surgery patients then had endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard; change in ETT tip position caused by traction up to 15N measured prior to surgery.~Adverse events were not reported per arm because surgery patients were assessed for adverse events after experiencing both methods."
640747|NCT02347176|B5|Baseline|Total|Total of all reporting groups
640748|NCT02347176|B4|Baseline|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640749|NCT02347176|B3|Baseline|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640750|NCT02347176|B2|Baseline|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640751|NCT02347176|B1|Baseline|Placebo|Placebo was administered subcutaneously to participants.
640752|NCT02347176|P4|Participant Flow|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640753|NCT02347176|P3|Participant Flow|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640754|NCT02347176|P2|Participant Flow|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640755|NCT02347176|P1|Participant Flow|Placebo|Placebo was administered subcutaneously to participants.
640756|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640757|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640758|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640759|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640760|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640761|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640762|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640763|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640834|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640764|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640765|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640766|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640767|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640768|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640769|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640770|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640771|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640772|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640773|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640774|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640775|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640776|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640777|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640778|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640779|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640780|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640781|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640782|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640783|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640784|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640785|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640786|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640787|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640788|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640789|NCT02347176|O3|Outcome|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640790|NCT02347176|O2|Outcome|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640791|NCT02347176|O1|Outcome|Placebo|Placebo was administered subcutaneously to participants.
640792|NCT02347176|O4|Outcome|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
652859|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
640796|NCT02347176|E4|Reported Event|Tralokinumab Dose 3|Tralokinumab Dose 3 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640797|NCT02347176|E3|Reported Event|Tralokinumab Dose 2|Tralokinumab Dose 2 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640798|NCT02347176|E2|Reported Event|Tralokinumab Dose 1|Tralokinumab Dose 1 was administered subcutaneously once every 2 Weeks (Q2W) for 12 weeks.
640799|NCT02347176|E1|Reported Event|Placebo|Placebo was administered subcutaneously to participants.
640800|NCT02347085|B1|Baseline|All Subjects|
640801|NCT02347085|P1|Participant Flow|Overall Study|All subjects randomized
640802|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640803|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640804|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640805|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640806|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640807|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640808|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640809|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640810|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640811|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640812|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640813|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640814|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640815|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640816|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640817|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640818|NCT02347085|O2|Outcome|Placebo|Placebo MDI
640819|NCT02347085|O1|Outcome|GFF MD (PT003)|GFF MDI 14.4/9.6 µg
640820|NCT02347085|E2|Reported Event|Placebo|Placebo MDI
640821|NCT02347085|E1|Reported Event|GFF MDI PT003|GFF MDI 14.4/9.6 µg
640822|NCT02347072|B1|Baseline|All Subjects|
640823|NCT02347072|P1|Participant Flow|Overall Study|All Subjects Randomized
640824|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640825|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640826|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640827|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640828|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640829|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640835|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640836|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640837|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640838|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640839|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640840|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640841|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640842|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640843|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640844|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640845|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640846|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640847|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640848|NCT02347072|O3|Outcome|Placebo|Placebo MDI
640849|NCT02347072|O2|Outcome|Spiriva Respimat|Spiriva Respimat 5μg
640850|NCT02347072|O1|Outcome|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640851|NCT02347072|E3|Reported Event|Placebo|Placebo MDI
640852|NCT02347072|E2|Reported Event|Spiriva Respimat|Spiriva Respimat 5μg
640853|NCT02347072|E1|Reported Event|GFF MDI|Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
640854|NCT02346877|B3|Baseline|Total|Total of all reporting groups
640855|NCT02346877|B2|Baseline|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
640856|NCT02346877|B1|Baseline|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
640857|NCT02346877|P2|Participant Flow|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
640858|NCT02346877|P1|Participant Flow|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
640859|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
641522|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
640860|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
640861|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
640862|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
640863|NCT02346877|O2|Outcome|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
640864|NCT02346877|O1|Outcome|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
640865|NCT02346877|E2|Reported Event|Personalized Patient Counselling (Interventional) Cohort|Participants enrolled in the interventional cohort were to receive Enbrel® (etanercept) therapy and personalized patient counselling using the Information-Motivation-Strategy (IMS) model based on Beliefs about Medicines Questionnaire (BMQ) results through a patient assistance program for patients on Enbrel (etanercept) therapy.
640866|NCT02346877|E1|Reported Event|Standard of Care (Control) Cohort|The first 100 participants were to be enrolled in the standard of care cohort. These participants received treatment with Enbrel® (etanercept) in routine clinical practice and were to complete a 52 week study period as per the investigator's standard of care.
640867|NCT02346721|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
640868|NCT02346721|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL; Epclusa®) (400/100 mg) fixed-dose combination (FDC) tablet orally once daily
640869|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
640870|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
640871|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg fixed-dose combination (FDC) tablet orally once daily
640872|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
640873|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
642046|NCT02330588|O3|Outcome|Move It (Injunctive Feedback)|
640874|NCT02346721|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL 400/100 mg FDC tablet orally once daily
640875|NCT02346721|E1|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet orally once daily
640876|NCT02345720|B1|Baseline|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
640877|NCT02345720|P1|Participant Flow|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
640878|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
640879|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
640880|NCT02345720|O1|Outcome|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
640881|NCT02345720|E1|Reported Event|Etafilcon PVP (Multi-focal)|All subjects wore the same study lenses throughout the duration of this study.
640882|NCT02344745|B3|Baseline|Total|Total of all reporting groups
640883|NCT02344745|B2|Baseline|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640884|NCT02344745|B1|Baseline|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640885|NCT02344745|P2|Participant Flow|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640886|NCT02344745|P1|Participant Flow|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640887|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640888|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640889|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
641523|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
640890|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640891|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640892|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640893|NCT02344745|O2|Outcome|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640894|NCT02344745|O1|Outcome|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640895|NCT02344745|E2|Reported Event|Lavender|"Lavandula angustifolia essential oil (Aura Cacia)~Lavandula angustifolia essential oil (Aura Cacia): The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640896|NCT02344745|E1|Reported Event|Control|"Distilled water~Distilled water: The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure."
640897|NCT02344342|B5|Baseline|Total|Total of all reporting groups
640898|NCT02344342|B4|Baseline|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
640899|NCT02344342|B3|Baseline|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
640900|NCT02344342|B2|Baseline|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
640901|NCT02344342|B1|Baseline|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
640902|NCT02344342|P4|Participant Flow|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
640903|NCT02344342|P3|Participant Flow|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
640904|NCT02344342|P2|Participant Flow|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
640905|NCT02344342|P1|Participant Flow|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
640906|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
640907|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
640908|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic Regimen No|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
640909|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
640910|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
640911|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
640912|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
640913|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
640914|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
640915|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
640916|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
640917|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
640918|NCT02344342|O4|Outcome|Health Buddy No and Flexible Diuretic No|"Telemonitoring: No~Flexible Diuretic No"
640919|NCT02344342|O3|Outcome|Health Buddy No and Flexible Diuretic Yes|"Telemonitoring: No~Flexible Diuretic Yes"
640920|NCT02344342|O2|Outcome|Health Buddy Yes and Flexible Diuretic No|"Telemonitoring: Yes~Flexible Diuretic No"
640921|NCT02344342|O1|Outcome|Health Buddy Yes and Flexible Diuretic Yes|"Telemonitoring: Yes~Flexible Diuretic Yes"
640922|NCT02344342|E4|Reported Event|Health Buddy Web NO /Flexible Diuretic NO|"Telemonitoring: These patients will not be assigned to the Health Buddy Web intervention.~Flexible Diuretic Regimen: These patients will not be assigned to follow a flexible diuretic regimen."
640923|NCT02344342|E3|Reported Event|Health Buddy Web NO/Flexible Diuretic YES|"Telemonitoring: These patients will not receive care with the Health Buddy Web intervention.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
640924|NCT02344342|E2|Reported Event|Health Buddy Web YES /Flexible Diuretic NO|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: These patients will not be assigned to receive a flexible diuretic prescription"
640925|NCT02344342|E1|Reported Event|Health Buddy Web YES/Flexible Diuretic YES|"Telemonitoring: The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.~Flexible Diuretic Regimen: Patients will have a prescribed diuretic regimen specified by specific weight ranges."
640926|NCT02343380|B3|Baseline|Total|Total of all reporting groups
640927|NCT02343380|B2|Baseline|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640928|NCT02343380|B1|Baseline|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640929|NCT02343380|P2|Participant Flow|Evening-first, Then Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640930|NCT02343380|P1|Participant Flow|Morning-first, Then Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640931|NCT02343380|O2|Outcome|Evening|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640957|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640932|NCT02343380|O1|Outcome|Morning|"Variation in morning triglyceride and free fatty acid (FFA) Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 am.~The metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640933|NCT02343380|O2|Outcome|Evening|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00 pm
640934|NCT02343380|O1|Outcome|Morning|Variation in morning glucose and insulin Area-Under the Curve (AUC)s after the consumption of a meal at 8:00
640935|NCT02343380|O2|Outcome|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640936|NCT02343380|O1|Outcome|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640937|NCT02343380|E2|Reported Event|Evening|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640938|NCT02343380|E1|Reported Event|Morning|"calorimetric exam after a standard meal~calorimetric exam after a standard meal: The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting"
640939|NCT02343159|B4|Baseline|Total|Total of all reporting groups
640940|NCT02343159|B3|Baseline|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640941|NCT02343159|B2|Baseline|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640942|NCT02343159|B1|Baseline|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640943|NCT02343159|P3|Participant Flow|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640944|NCT02343159|P2|Participant Flow|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640945|NCT02343159|P1|Participant Flow|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
641081|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
640946|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640947|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640948|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640949|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640950|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640951|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640952|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640953|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640954|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640955|NCT02343159|O3|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640956|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640986|NCT02342704|B3|Baseline|Total|Total of all reporting groups
640958|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640959|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640960|NCT02343159|O2|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640961|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640962|NCT02343159|O2|Outcome|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640963|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640964|NCT02343159|O2|Outcome|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640965|NCT02343159|O1|Outcome|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640966|NCT02343159|E3|Reported Event|Arm 3: Smart MEMS Cap + Counseling|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings) and an adherence counseling intervention. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640967|NCT02343159|E2|Reported Event|Arm 2: Smart MEMS Cap|A smart MEMS cap with feedback (an LCD reader that allows the participant to monitor DMF bottle openings). Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640968|NCT02343159|E1|Reported Event|Arm 1: Standard MEMS Cap|A standard MEMS cap that records the time and date when the bottle is opened without a visual LCD reader. Standard-of-care commercial supply of DMF (BID oral capsule) will be used in this study.
640969|NCT02343081|B3|Baseline|Total|Total of all reporting groups
640970|NCT02343081|B2|Baseline|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
641018|NCT02342561|O1|Outcome|Intervention Knees (Drape Side)|"One knee of the patient were randomly selected to be draped with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
641019|NCT02342561|O2|Outcome|Control Knee (No-drape Knees)|The knee that is not drape is left uncovered during the intervention.
640971|NCT02343081|B1|Baseline|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
640972|NCT02343081|P2|Participant Flow|Dralitem, Then Temodal|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A.(Dralitem®). All patients were under fasting conditions two hours before and after each drug administration.
640973|NCT02343081|P1|Participant Flow|Temodal, Then Dralitem|During days 1 and 2, all patients received a single oral dose of 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 3 patients received 200 mg/m2 of Temozolomide from Schering-Plough (Temodal®) as a single oral dose. After a washout period of 10 hours, they then received 200 mg/m2 of Temozolomide from Monte Verde S.A. (Dralitem®). On day 5 all patients received Temozolomide 200 mg/m2 from Monte Verde S.A. (Dralitem®).All patients were under fasting conditions two hours before and after each drug administration.
640974|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
640975|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
640976|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
640977|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
640978|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
640979|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
640980|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
640981|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
640982|NCT02343081|O2|Outcome|Dralitem|"Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose~Temozolomide"
640983|NCT02343081|O1|Outcome|Temodal|"Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.~Temozolomide"
640984|NCT02343081|E2|Reported Event|Dralitem|Temozolomide (Monte Verde S.A.) 200 mg/m2, single oral dose.
640985|NCT02343081|E1|Reported Event|Temodal|Temozolomide (Schering-Plough) 200 mg/m2, single oral dose.
640987|NCT02342704|B2|Baseline|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
640988|NCT02342704|B1|Baseline|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
640989|NCT02342704|P2|Participant Flow|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
640990|NCT02342704|P1|Participant Flow|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
640991|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
640992|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
640993|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
640994|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
640995|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
640996|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
640997|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
640998|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
640999|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641000|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641001|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641002|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641003|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641004|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641005|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641006|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641007|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641008|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641009|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641010|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641011|NCT02342704|O2|Outcome|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641012|NCT02342704|O1|Outcome|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641013|NCT02342704|E2|Reported Event|Fingolimod|Open-label fingolimod 0.5 mg once daily orally
641014|NCT02342704|E1|Reported Event|Natalizumab|Open-label natalizumab 300 mg IV every 4 weeks
641015|NCT02342561|B1|Baseline|Intervention Knees (Draped Knees) and Control Knees (No-draped|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The knee that is not drape is left uncovered during the intervention."
641016|NCT02342561|P1|Participant Flow|Intervention Knee (Drape Side) and Control Knee (No Drape Side|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.~The control knee that is not drape is left uncovered during the intervention."
641017|NCT02342561|O2|Outcome|Control Knees (No-drape Side)|The knees were not drape were left uncovered during the intervention.
641339|NCT02339246|E3|Reported Event|Prograf|Prograf capsules twice daily.
641020|NCT02342561|O1|Outcome|Intervention Knee (Draped Knees)|"One knee of the patient is randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
641021|NCT02342561|E2|Reported Event|Control Knees|The knees that were not drape is left uncovered during the intervention.
641022|NCT02342561|E1|Reported Event|Intervention Knees|"One knee of the patient were randomly selected to be drape with an Ioban 2 incision drape.~Ioban 2 incision drape, 3M: The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions."
641023|NCT02342418|B3|Baseline|Total|Total of all reporting groups
641024|NCT02342418|B2|Baseline|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641025|NCT02342418|B1|Baseline|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641026|NCT02342418|P2|Participant Flow|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641027|NCT02342418|P1|Participant Flow|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641028|NCT02342418|O2|Outcome|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641029|NCT02342418|O1|Outcome|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641030|NCT02342418|O2|Outcome|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641031|NCT02342418|O1|Outcome|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641032|NCT02342418|E2|Reported Event|Non-obese|"Each non-obese subject will be matched to a morbidly obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641033|NCT02342418|E1|Reported Event|Morbidly Obese|"The morbidly obese (BMI ≥ 40 kg/m2) arm will be recruited first. Each morbidly obese subject will be matched to a non-obese subject (BMI 18.5-29.9 kg/m2) based on age (± 5 years), sex, and ideal body weight (± 4.6 kg, i.e. ± 5 cm in height). Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.~Tedizolid phosphate: Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter."
641034|NCT02342288|B3|Baseline|Total|Total of all reporting groups
641035|NCT02342288|B2|Baseline|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641036|NCT02342288|B1|Baseline|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641340|NCT02339246|E2|Reported Event|Astagraf XR|Astagraf XR capsules once daily.
641037|NCT02342288|P2|Participant Flow|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641038|NCT02342288|P1|Participant Flow|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641039|NCT02342288|O2|Outcome|Head in Neutral Position|"Head in neutral position~Head in neutral position: Five minutes after turning prone, an IOP measurement was obtained. After 5 minutes an IOP measurement was taken. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641040|NCT02342288|O1|Outcome|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Five minutes after turning prone, an IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes an IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641041|NCT02342288|E2|Reported Event|Head in Neutral Position|"Head in neutral position~Head in neutral position: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641231|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641042|NCT02342288|E1|Reported Event|Head Raised 10 Degrees|"Head raised 10 degrees from neutral position using Gardner Wells tongs~Head raised 10 degrees: Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration."
641043|NCT02342223|B1|Baseline|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641044|NCT02342223|P1|Participant Flow|Voluma Treatment of HIV Facial Lipoatrophy|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641045|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641046|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641047|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641048|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641049|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641341|NCT02339246|E1|Reported Event|Envarsus XR|Envarsus XR tablets once daily.
652860|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
641050|NCT02342223|O1|Outcome|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641051|NCT02342223|E1|Reported Event|Voluma|"Subjects were screened for severity on their HIV facial lipoatrophy according to the Carruthers Lipoatrophy Severity Scale (CLSS), and received subcutaneous injections of Voluma in the affected facial areas with the smile and fill technique (Jagdeo 2014) based on Carruthers scoring scale.~All subjects received one Voluma treatment at initial time = 0 and may be eligible for touchup treatment, if necessary, at 2 weeks post-initial treatment."
641052|NCT02342197|B3|Baseline|Total|Total of all reporting groups
641053|NCT02342197|B2|Baseline|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
641054|NCT02342197|B1|Baseline|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
641055|NCT02342197|P2|Participant Flow|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
641056|NCT02342197|P1|Participant Flow|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
641057|NCT02342197|O2|Outcome|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
641058|NCT02342197|O1|Outcome|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
641059|NCT02342197|E2|Reported Event|Microdose Flare Protocol|"Half the dose of GnRH agonist (Decapeptyl 0.05) was started on the second day of the cycle together with Gn's~Decapeptyl: half the dose of Gn agonist"
641060|NCT02342197|E1|Reported Event|Minidose Long Protocol|"Half dose of GnRH agonist (Decapeptyl 0.05) was started in the midluteal phase and Gn's was started from the second day of the cycle.~Decapeptyl: half the dose of Gn agonist"
641061|NCT02341859|B1|Baseline|Overall Participant Flow|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
641062|NCT02341859|P2|Participant Flow|Stenfilcon A/Narafilcon A, Then Stenfilcon A/Delefilcon A|"Participants randomized wear the stenfilcon A and narafilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and delefilcon A lens pair contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens~delefilcon A: contact lens"
641063|NCT02341859|P1|Participant Flow|Stenfilcon A/Delefilcon A, Then Stenfilcon A/Narafilcon A|"Participants randomized wear the stenfilcon A and delefilcon A lens pair contralaterally, and then cross over to wear the stenfilcon A and narafilcon A lens pair contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
641064|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641065|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641066|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641067|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641068|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641069|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641070|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641071|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641072|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641073|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641074|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641075|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641076|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641077|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641078|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641079|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641080|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
652861|NCT02204579|O1|Outcome|NPSP795|
641082|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641083|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641084|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641085|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641086|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641087|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641088|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641089|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641090|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641091|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641092|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641093|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641094|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641095|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641096|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641375|NCT02338336|E2|Reported Event|Nowarta110|All combined Nowarta110 doses
641097|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641098|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641099|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641100|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641101|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641102|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641103|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641104|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641105|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641106|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641107|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641108|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641109|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641110|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641111|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641112|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641113|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641114|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641115|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641116|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641117|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
652862|NCT02204579|O1|Outcome|NPSP795|
641118|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641119|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641120|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641121|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641122|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641123|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641124|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641125|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641126|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641127|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641128|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641129|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641130|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641131|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641132|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641133|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641134|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641135|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641136|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641137|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641138|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641139|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641140|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641141|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641142|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641143|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641144|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641145|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641146|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641147|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641148|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641149|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641150|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641151|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641152|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641153|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
652863|NCT02204579|O1|Outcome|NPSP795|
641154|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641155|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641156|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641157|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641158|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641159|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641160|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641161|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641162|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641163|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641164|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641165|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641166|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641167|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641168|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641169|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641170|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641171|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641172|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641173|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641174|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641175|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641176|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641177|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641178|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641179|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641180|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641181|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641182|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641183|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641184|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641185|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641186|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641187|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641188|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641189|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
652864|NCT02204579|O1|Outcome|NPSP795|
641190|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641191|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641192|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641193|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641194|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641195|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641196|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641197|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641198|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641199|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641200|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641201|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641202|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641203|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641204|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641205|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641206|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641207|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641208|NCT02341859|O4|Outcome|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally.~stenfilcon A: contact lens~narafilcon A: contact lens"
641209|NCT02341859|O3|Outcome|Stenfilcon A (Narafilcon A Group)|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641210|NCT02341859|O2|Outcome|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641211|NCT02341859|O1|Outcome|Stenfilcon A (Delefilcon A Group)|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally.~stenfilcon A: contact lens~delefilcon A: contact lens"
641212|NCT02341859|E3|Reported Event|Narafilcon A|"Participants randomized wear the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~narafilcon A: contact lens"
641213|NCT02341859|E2|Reported Event|Delefilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens"
641214|NCT02341859|E1|Reported Event|Stenfilcon A|"Participants randomized wear the stenfilcon A and the delefilcon A contralaterally or the stenfilcon A and the narafilcon A contralaterally~stenfilcon A: contact lens~delefilcon A: contact lens~narafilcon A: contact lens"
641215|NCT02341482|B1|Baseline|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
641216|NCT02341482|P1|Participant Flow|All Subjects|PF-04958242 0.10 milligram (mg) loading dose was administered orally twice daily (BID) on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), once daily (QD).
641217|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
641218|NCT02341482|O3|Outcome|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
641219|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
641220|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641349|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641350|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641221|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
641222|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
641223|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
641224|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
641225|NCT02341482|O1|Outcome|All Subjects|PF-04958242 0.10 mg loading dose was administered orally BID on Day 1. Each participant was given 2 daily doses of PF-04958242 (0.025 mg) orally for 16 subsequent days (Day 2 to Day 17), with the last dose occurring in the morning of Day 17. On Day 4, a 200 mg dose of itraconazole was administered orally approximately 1 hour before PF-04958242 morning administration and for 13 additional days (Day 4 to Day 17), QD.
641226|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
641227|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641228|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
641229|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641230|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
641232|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
641233|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641234|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
641235|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641236|NCT02341482|O2|Outcome|PF-04958242 0.025 mg + Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg BID combined with Itraconazole 200 mg QD orally.
641237|NCT02341482|O1|Outcome|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641238|NCT02341482|E3|Reported Event|PF-04958242 0.025 mg Combined With Itraconazole 200 mg|All participants who received PF-04958242 0.025 mg combined with itraconazole 200 mg orally.
641239|NCT02341482|E2|Reported Event|PF-04958242 0.025 mg|All participants who received PF-04958242 0.025 mg BID orally.
641240|NCT02341482|E1|Reported Event|PF-04958242 0.1 mg|All participants who received PF-04958242 0.1 mg BID orally.
641241|NCT02341144|B3|Baseline|Total|Total of all reporting groups
641242|NCT02341144|B2|Baseline|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641243|NCT02341144|B1|Baseline|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641244|NCT02341144|P2|Participant Flow|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641245|NCT02341144|P1|Participant Flow|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641246|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641247|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641248|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641249|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641250|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641251|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641303|NCT02339831|P1|Participant Flow|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641304|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641252|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641253|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641254|NCT02341144|O2|Outcome|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641255|NCT02341144|O1|Outcome|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641256|NCT02341144|E2|Reported Event|Intra-operative Rectus Sheath Block|"rectus sheath block under direct visualization by the attending surgeon~Intra-operative rectus sheath block: After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.~Ropivacaine"
641257|NCT02341144|E1|Reported Event|Pre-op Percutaneous Rectus Sheath Block|"ultrasound-guided, percutaneous rectus sheath block by a qualified anesthesiologist~Pre-op percutaneous rectus sheath block: After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.~Ropivacaine"
641258|NCT02340338|B8|Baseline|Total|Total of all reporting groups
641259|NCT02340338|B7|Baseline|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641351|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641524|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641260|NCT02340338|B6|Baseline|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641261|NCT02340338|B5|Baseline|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641262|NCT02340338|B4|Baseline|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641305|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641306|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641263|NCT02340338|B3|Baseline|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641264|NCT02340338|B2|Baseline|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641265|NCT02340338|B1|Baseline|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641266|NCT02340338|P7|Participant Flow|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641267|NCT02340338|P6|Participant Flow|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641342|NCT02338713|B1|Baseline|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
641352|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
652865|NCT02204579|E1|Reported Event|NPSP795|
641268|NCT02340338|P5|Participant Flow|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641269|NCT02340338|P4|Participant Flow|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641270|NCT02340338|P3|Participant Flow|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641271|NCT02340338|P2|Participant Flow|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641272|NCT02340338|P1|Participant Flow|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641273|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641274|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641275|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641343|NCT02338713|P1|Participant Flow|Noncarbonated Water+Calcichew D3|Noncarbonated water 200 milliliter (mL), orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period) followed by Calcichew D3 500 milligram (mg)/1000 international units (IU) (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period) of 6 days treatment period.
641344|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
652866|NCT02204449|B3|Baseline|Total|Total of all reporting groups
641276|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641277|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641278|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641279|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641280|NCT02340338|O7|Outcome|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641281|NCT02340338|O6|Outcome|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641282|NCT02340338|O5|Outcome|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641283|NCT02340338|O4|Outcome|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641284|NCT02340338|O3|Outcome|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641285|NCT02340338|O2|Outcome|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641286|NCT02340338|O1|Outcome|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641287|NCT02340338|E7|Reported Event|Dose Group 0|"Control: Al(OH)3 Adjuvant~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641288|NCT02340338|E6|Reported Event|Dose Group 6|"Treatment: rTSST-1 Variant Candidate Vaccine 30 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641289|NCT02340338|E5|Reported Event|Dose Group 5|"Treatment: rTSST-1 Variant Candidate Vaccine 10 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641290|NCT02340338|E4|Reported Event|Dose Group 4|"Treatment: rTSST-1 Variant Candidate Vaccine 3 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641291|NCT02340338|E3|Reported Event|Dose Group 3|"Treatment: rTSST-1 Variant Candidate Vaccine 1 µg~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641292|NCT02340338|E2|Reported Event|Dose Group 2|"Treatment: rTSST-1 Variant Candidate Vaccine 300 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641345|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641346|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641347|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641348|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641293|NCT02340338|E1|Reported Event|Dose Group 1|"Treatment: rTSST-1 Variant Candidate Vaccine 100 ng~rTSST-1 Variant Candidate Vaccine: In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .~Patients 3 µg or more will be randomized."
641294|NCT02340104|B1|Baseline|All Participants|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
641295|NCT02340104|P1|Participant Flow|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and approximately the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours.
641296|NCT02340104|O2|Outcome|[^13C4D3^15N]-Baricitinib IV|Single intravenous (IV) infusion of 4 µg[^13C4D3^15N]-baricitinib over 1.5 hours
641297|NCT02340104|O1|Outcome|Baricitinib Oral Dose|Single oral dose of 4 mg baricitinib
641298|NCT02340104|E1|Reported Event|Baricitinib|Single oral dose of 4 mg baricitinib on Day 1 and at the same time a single intravenous (IV) infusion of 4 µg [^13C4D3^15N]-baricitinib over 1.5 hours
641299|NCT02339831|B3|Baseline|Total|Total of all reporting groups
641300|NCT02339831|B2|Baseline|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641301|NCT02339831|B1|Baseline|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641302|NCT02339831|P2|Participant Flow|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641373|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
641374|NCT02338336|O1|Outcome|Placebo|Matching Placebo
641307|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641308|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641309|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641310|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641311|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641312|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641313|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641314|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641315|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641316|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641317|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641318|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641319|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641320|NCT02339831|O2|Outcome|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641321|NCT02339831|O1|Outcome|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641322|NCT02339831|E2|Reported Event|Passive Motion Device|Patients assigned to this group receive the continuous passive motion device (CPM) after surgery.
641323|NCT02339831|E1|Reported Event|Active Motion Device|Patients assigned to this group receive the active motion device (CAM, Camoped) after surgery.
641324|NCT02339246|B3|Baseline|Total|Total of all reporting groups
641325|NCT02339246|B2|Baseline|Prograf vs Astagraf XL vs Envarsus XR|"Prograf capsules twice daily Astagraf XL capsules once daily Envarsus XR tablets once daily~Prograf vs Astagraf XL vs Envarsus XR: Prograf vs Astagraf XL vs Envarsus XR"
641326|NCT02339246|B1|Baseline|Prograf vs Envarsus XR vs Astagraf XL|"Prograft capsules Twice daily Envarsus XR tablets once daily Astagraf XL capsules once daily~Prograf vs Envarsus XR vs Astagraf XL: prograf vs Envarsus XR vs Astagraf XL"
641327|NCT02339246|P3|Participant Flow|Prograf|Prograf capsules twice daily.
641328|NCT02339246|P2|Participant Flow|Astagraf XL|Astagraf XL capsules once daily.
641329|NCT02339246|P1|Participant Flow|Envarsus XR|Envarsus XR tablets once daily.
641330|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
641331|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
641332|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
641333|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
641334|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
641335|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
641336|NCT02339246|O3|Outcome|Prograf|Prograf capsules twice daily.
641337|NCT02339246|O2|Outcome|Astagraf XL|Astagraf XL capsules once daily.
641338|NCT02339246|O1|Outcome|Envarsus XR|Envarsus XR tablets once daily.
641353|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641354|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641355|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641356|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641357|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641358|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641359|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641360|NCT02338713|O2|Outcome|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641361|NCT02338713|O1|Outcome|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641362|NCT02338713|E2|Reported Event|Calcichew D3|Calcichew D3 500 mg/1000 IU (Calcium 500 mg, chewable tablets and vitamin D3 1000 IU, chewable tablets), orally, once daily on Days 4, 5 and 6 in period 2 (study treatment period).
641363|NCT02338713|E1|Reported Event|Noncarbonated Water|Noncarbonated water 200 mL, orally, once daily on Days 1, 2 and 3 in period 1 (dummy treatment period).
641364|NCT02338336|B3|Baseline|Total|Total of all reporting groups
641365|NCT02338336|B2|Baseline|Nowarta110|All combined Nowarta110 doses
641366|NCT02338336|B1|Baseline|Placebo|Matching Placebo
641367|NCT02338336|P4|Participant Flow|Nowarta110 10 Drops|Nowarta110 10 drops administered topically
641368|NCT02338336|P3|Participant Flow|Nowarta110 6 Drops|Nowarta110 6 drops administered topically
641369|NCT02338336|P2|Participant Flow|Norwarta110 3 Drops|Nowarta110 3 drops administered topically
641370|NCT02338336|P1|Participant Flow|Placebo|Matching Placebo
641371|NCT02338336|O2|Outcome|TREATMENT|Nowarta110
641372|NCT02338336|O1|Outcome|Placebo|Matching Placebo
641377|NCT02338076|B1|Baseline|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641378|NCT02338076|P1|Participant Flow|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641379|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641380|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641381|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641382|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641383|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641503|NCT02336425|P2|Participant Flow|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641384|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641385|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641386|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641387|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641388|NCT02338076|O3|Outcome|Control Arm/Normal Skin|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641429|NCT02336607|B2|Baseline|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641389|NCT02338076|O2|Outcome|Arm With Occlusion Only (Without Petrolatum)|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641390|NCT02338076|O1|Outcome|Interventional Arm With Petrolatum|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641391|NCT02338076|E1|Reported Event|Interventional Arm|"petrolatum application under occlusion~Petrolatum application under occlusion: Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)~1 well will be empty and the other well will contain petrolatum~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
641392|NCT02337959|B4|Baseline|Total|Total of all reporting groups
641393|NCT02337959|B3|Baseline|Predicate & Investigational-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
641394|NCT02337959|B2|Baseline|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
641395|NCT02337959|B1|Baseline|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
641396|NCT02337959|P3|Participant Flow|Predicate & Investigational - Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using the both the GoS and the CsI investigational detector.
641397|NCT02337959|P2|Participant Flow|Predicate & Investigational - CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
641398|NCT02337959|P1|Participant Flow|Predicate & Investigational - GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
641399|NCT02337959|O1|Outcome|Image Pair Preference|Preference for predicate detector DRX-1 image versus preference for investigational DRX-Plus 3543/C (GOS & CsI) and vice versa.
641400|NCT02337959|O2|Outcome|Investigational|DRX Plus 3543/C (GOS & CsI) Detectors, Cadavers & Live Subjects
641401|NCT02337959|O1|Outcome|Predicate|DRX-1 Detector, Cadavers & Live Subjects
641402|NCT02337959|E3|Reported Event|Predicate & Invest.-Cadavers GOS & CsI|Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
641403|NCT02337959|E2|Reported Event|Predicate & Invest.-CsI|Each subject will receive one x-ray using the predicate detector and one x-ray using the CsI investigational detector.
641404|NCT02337959|E1|Reported Event|Predicate & Invest.-GOS|Each subject will receive one x-ray using the predicate detector and one x-ray using the GOS investigational detector.
641405|NCT02336958|B3|Baseline|Total|Total of all reporting groups
641504|NCT02336425|P1|Participant Flow|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641505|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641406|NCT02336958|B2|Baseline|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
641407|NCT02336958|B1|Baseline|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
641408|NCT02336958|P2|Participant Flow|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
641409|NCT02336958|P1|Participant Flow|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
641410|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
641447|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
642047|NCT02330588|O2|Outcome|Eat It (Normative Feedback)|
641411|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
641412|NCT02336958|O2|Outcome|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
641413|NCT02336958|O1|Outcome|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
641414|NCT02336958|E2|Reported Event|Saline|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage.~pericarotidal infiltration (placebo comparator) saline: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration."
641415|NCT02336958|E1|Reported Event|Ropivacaine|"Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%.~intermediate cervical plexus block ropivacaine: 20ml ultrasound guided intermediate cervical plexus block.~pericarotidal infiltration (active comparator) ropivacaine: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.~jugular infiltration prilocaine: 5ml prilocaine 1% jugular infiltration for wound drainage."
641416|NCT02336763|B1|Baseline|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641417|NCT02336763|P1|Participant Flow|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641418|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641419|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641420|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641421|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641506|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641507|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641422|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641423|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641424|NCT02336763|O1|Outcome|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641425|NCT02336763|E1|Reported Event|Treatment (External Beam Radiation Therapy)|"Patients undergo external beam radiation therapy daily over 20 minutes on Monday-Friday for up to 10 fractions over approximately 2 weeks.~External Beam Radiation Therapy: Undergo external beam radiation therapy~Laboratory Biomarker Analysis: Correlative studies"
641426|NCT02336607|B5|Baseline|Total|Total of all reporting groups
641427|NCT02336607|B4|Baseline|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641428|NCT02336607|B3|Baseline|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641542|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641543|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641544|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641545|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641430|NCT02336607|B1|Baseline|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641431|NCT02336607|P4|Participant Flow|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641432|NCT02336607|P3|Participant Flow|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641433|NCT02336607|P2|Participant Flow|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641434|NCT02336607|P1|Participant Flow|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641435|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641436|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641437|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641438|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641439|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641440|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641508|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641509|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641441|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641442|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641443|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641444|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641445|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641446|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641448|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641449|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641450|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641451|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641452|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641453|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641454|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641455|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641456|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641457|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641510|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641511|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641458|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641459|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641460|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641461|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641462|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641463|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641464|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641465|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641466|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641467|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641468|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641469|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641470|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641471|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641472|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641473|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641474|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641475|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641476|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641477|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641478|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641479|NCT02336607|O4|Outcome|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641480|NCT02336607|O3|Outcome|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641481|NCT02336607|O2|Outcome|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641546|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641547|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641482|NCT02336607|O1|Outcome|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641483|NCT02336607|E4|Reported Event|Felodipine Tablet (Plendil)|Felodipine ER 5mg qd, the patients who didn't achive the target blood pressure (140/90) after 2 weeks (week1 and week2), switch to combination thearapies.
641484|NCT02336607|E3|Reported Event|Felodipine Tablet (Plendil)+Hydrochlorothiazide|Felodipine ER 5mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Hydrochlorothiazide 12.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Hydrochlorothiazide 25mg qd till the end of the study (week 14).
641485|NCT02336607|E2|Reported Event|Felodipine Tablets (Plendil)+Lisinopril (Zestril)|Felodipine ER 5mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Lisinopril 10mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Lisinopril 20mg qd till the end of the study ( week 14).
641486|NCT02336607|E1|Reported Event|Felodipine Tablet (Plendil)+Metoprolol Tablet (Betaloc ZOK)|Felodipine ER 5mg qd + Metoprolol ER 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration,rise dose to Felodipine ER 10mg qd + Metoprolol 47.5mg qd; patients who didn't reach the target blood pressure(140/90) after 2 weeks since first administeration, rise the dose to Felodipine 10mg qd + Metoprolol 95mg qd till the end of the study (week 14).
641487|NCT02336438|B1|Baseline|Baseline Phase (Control), Crossover to Treatment (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641488|NCT02336438|P1|Participant Flow|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro® Continuous Glucose Monitor (CGM) device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641512|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641513|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641514|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641515|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641516|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641517|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641518|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641519|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641489|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641490|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641548|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641549|NCT02336425|E4|Reported Event|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641550|NCT02336425|E3|Reported Event|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641551|NCT02336425|E2|Reported Event|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641552|NCT02336425|E1|Reported Event|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
642048|NCT02330588|O1|Outcome|Eat It (Injunctive Feedback)|
641491|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641492|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641493|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641494|NCT02336438|O1|Outcome|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Tests, which includes consumption of a standard meal (Boost) and scheduled blood draws over 3 hours.~Glucomannan:~iPro CGM device will be worn for 5 days. Subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times/day for next 5 days and log this onto the System Patient Log.~Subjects will undergo Mixed Meal Tolerance Testing, which includes consumption of a standard meal (Boost) + 5 grams of Glucomannan soluble fiber powder and scheduled blood draws over 3 hours.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641495|NCT02336438|E1|Reported Event|Baseline Phase (Control) and Treatment Phase (Glucomannan)|"Control:~iPro CGM device will be worn for 5 days. The subjects will maintain a diet history and will be given a One Touch glucometer and strips to check their blood glucose at home four times a day for next five days and log this onto the System Patient Log.~Glucomannan:~For the next five days subjects will take the following amounts of Glucomannan soluble fiber (provided by the investigator) three times a day with meals.~Breakfast: Take 5 grams (1 tsp) of Glucomannan. Lunch: Take 5 grams (1 tsp) of Glucomannan Dinner: Take 5 grams (1 tsp) of Glucomannan.~glucomannan: Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant."
641496|NCT02336425|B5|Baseline|Total|Total of all reporting groups
641497|NCT02336425|B4|Baseline|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641498|NCT02336425|B3|Baseline|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641499|NCT02336425|B2|Baseline|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641500|NCT02336425|B1|Baseline|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641501|NCT02336425|P4|Participant Flow|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641502|NCT02336425|P3|Participant Flow|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
653502|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
641525|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641526|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641527|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641528|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641529|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641530|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641531|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641532|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641533|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641534|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641535|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641536|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641537|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641538|NCT02336425|O3|Outcome|QGE031 24 mg|QGE031 24 mg subcutaneous injection every 4 weeks
641539|NCT02336425|O2|Outcome|QGE031 72 mg|QGE031 72 mg subcutaneous injection every 4 weeks
641540|NCT02336425|O1|Outcome|QGE031 240 mg|QGE031 240 mg subcutaneous injection every 4 weeks
641541|NCT02336425|O4|Outcome|Placebo to QGE031|Placebo subcutaneous injection every 4 weeks
641553|NCT02336178|B1|Baseline|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641554|NCT02336178|P1|Participant Flow|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641555|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641556|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641557|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641558|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641559|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641560|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641561|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641562|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641675|NCT02334982|P2|Participant Flow|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
653719|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
641563|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641564|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641565|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641566|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641567|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641568|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641569|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641647|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641570|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641571|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641572|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641573|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641574|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641575|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641576|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641577|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641578|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641579|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641580|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641581|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641582|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641583|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641584|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641585|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641586|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641587|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641588|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641589|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641590|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641591|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641592|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641593|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received prophylaxis treatment with BeneFIX according to usual care in China and in accord with the China BeneFIX Package Insert. The treatment duration was 6 months (±7 days) or 50 Exposure Days (±5 EDs) whichever occurred first. On-demand treatment was given as needed.
641594|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641595|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641596|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641597|NCT02336178|O5|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641598|NCT02336178|O4|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
642635|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
641599|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641600|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641601|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641602|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641603|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641604|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641605|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
642049|NCT02330588|O6|Outcome|eHealth Control|
641606|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641607|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641608|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641609|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641610|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641611|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641612|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641613|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641614|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641615|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641616|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641617|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641618|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641619|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641620|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641621|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641622|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641623|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641624|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641625|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641626|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641627|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641628|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641629|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641630|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641631|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641632|NCT02336178|O6|Outcome|Overall Participants|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received at least 1 dose of BeneFIX during the study.
641633|NCT02336178|O5|Outcome|Severe Participants (Factor IX Activity <1%)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641634|NCT02336178|O4|Outcome|Participants Receiving Prophylaxis Treatment|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first. This reporting arm included all participants who received prophylaxis treatment after enrollment in the study.
641635|NCT02336178|O3|Outcome|Previously Untreated Participants (PUPs)|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641636|NCT02336178|O2|Outcome|Pediatric Participants ≥6 to ≤12 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641637|NCT02336178|O1|Outcome|Pediatric Participants <6 Years of Age|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641638|NCT02336178|E1|Reported Event|BeneFIX|Participants received intravenous (IV) infusions of BeneFIX for on-demand or prophylaxis treatment at a dose and frequency prescribed by the participant’s treating physician in accordance with the China BeneFIX Package Insert for 6 months (±7 days) or 50 Exposure Days (EDs) (±5 EDs), whichever occurred first.
641639|NCT02335710|B3|Baseline|Total|Total of all reporting groups
641640|NCT02335710|B2|Baseline|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641641|NCT02335710|B1|Baseline|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II bi-cruciate stabilizing (BCS) total knee arthroplasty (TKA) implanted by Dr. Harold Cates~Journey II BCS TKA"
641642|NCT02335710|P2|Participant Flow|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641643|NCT02335710|P1|Participant Flow|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641644|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641645|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641646|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641648|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641649|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641650|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641651|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641652|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641653|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641654|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641655|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641656|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641657|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641658|NCT02335710|O2|Outcome|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641659|NCT02335710|O1|Outcome|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641660|NCT02335710|E2|Reported Event|Normal Knee|Subjects must have a healthy, functioning knee with no osteoarthritis or knee pathologies
641661|NCT02335710|E1|Reported Event|Smith & Nephew Journey II BCS TKA|"Subjects must be implanted with a Smith & Nephew Journey II BCS TKA implanted by Dr. Harold Cates~Journey II BCS TKA"
641662|NCT02334982|B8|Baseline|Total|Total of all reporting groups
641663|NCT02334982|B7|Baseline|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
641664|NCT02334982|B6|Baseline|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
641665|NCT02334982|B5|Baseline|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
641666|NCT02334982|B4|Baseline|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
641667|NCT02334982|B3|Baseline|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641668|NCT02334982|B2|Baseline|Cohort 2: TAK-137 5 mg|TAK-137 5 mg, tablets, orally, once on Day 1.
641669|NCT02334982|B1|Baseline|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
641670|NCT02334982|P7|Participant Flow|Cohorts 1-6: Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
641671|NCT02334982|P6|Participant Flow|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, once on Day 1.
641672|NCT02334982|P5|Participant Flow|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, once on Day 1.
641673|NCT02334982|P4|Participant Flow|Cohort 4: TAK-137 5 mg Food Effect|TAK-137 5 mg, tablets, orally, under fasted conditions, once on Day 1 of Period 1, followed by 14 days of follow-up, followed by TAK-137 5 mg, tablets, orally, under fed conditions, once on Day 1 of Period 2.
641674|NCT02334982|P3|Participant Flow|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
653722|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
641676|NCT02334982|P1|Participant Flow|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, once on Day 1.
641677|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641678|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641679|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641680|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641681|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641682|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641683|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641684|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641685|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641686|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641687|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641688|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641689|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641690|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641691|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641692|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641693|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641694|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641695|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641696|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641697|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641698|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641699|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641700|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641701|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641702|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641703|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641704|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641705|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641706|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641707|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641708|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641709|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641710|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641711|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641712|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641713|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641714|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641715|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641716|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641717|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641718|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641719|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641720|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641721|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641722|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641723|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641724|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641725|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641726|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641727|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641728|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641729|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641730|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641731|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
642636|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
641732|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641733|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641734|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641735|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641736|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641737|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641738|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641739|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641740|NCT02334982|O7|Outcome|Cohort 4: TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641741|NCT02334982|O6|Outcome|Cohort 6: TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641742|NCT02334982|O5|Outcome|Cohort 5: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641743|NCT02334982|O4|Outcome|Cohort 4: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1 of Period 1.
641744|NCT02334982|O3|Outcome|Cohort 3: TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641745|NCT02334982|O2|Outcome|Cohort 2: TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641746|NCT02334982|O1|Outcome|Cohort 1: TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641747|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
641748|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641749|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
641750|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641751|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641752|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641753|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641754|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641755|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
641756|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641757|NCT02334982|O6|Outcome|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
641758|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641759|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641760|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641761|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641762|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641763|NCT02334982|O8|Outcome|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
641764|NCT02334982|O7|Outcome|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641765|NCT02334982|O6|Outcome|TAK-137 Placebo|TAK-137 placebo-matching tablets, orally, once on Day 1.
641766|NCT02334982|O5|Outcome|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641767|NCT02334982|O4|Outcome|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641768|NCT02334982|O3|Outcome|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641769|NCT02334982|O2|Outcome|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641770|NCT02334982|O1|Outcome|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641771|NCT02334982|E8|Reported Event|Placebo (Fed)|TAK-137 placebo-matching tablets, orally, fed, once on Day 1of Period 2.
641772|NCT02334982|E7|Reported Event|TAK-137 5 mg (Fed)|TAK-137 5 mg, tablets, orally, fed, once, on Day 1 of Period 2.
641773|NCT02334982|E6|Reported Event|Placebo Fasting|TAK-137 placebo-matching tablets, orally, fasting, once on Day 1.
641774|NCT02334982|E5|Reported Event|TAK-137 20 mg|TAK-137 20 mg, tablets, orally, fasting, once on Day 1.
641775|NCT02334982|E4|Reported Event|TAK-137 10 mg|TAK-137 10 mg, tablets, orally, once on Day 1.
641776|NCT02334982|E3|Reported Event|TAK-137 5 mg (Fasting)|TAK-137 5 mg, tablets, orally, fasting, once on Day 1.
641777|NCT02334982|E2|Reported Event|TAK-137 2 mg|TAK-137 2 mg, tablets, orally, fasting, once on Day 1.
641778|NCT02334982|E1|Reported Event|TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally, fasting, once on Day 1.
641779|NCT02334813|B3|Baseline|Total|Total of all reporting groups
641780|NCT02334813|B2|Baseline|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
641781|NCT02334813|B1|Baseline|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
641782|NCT02334813|P2|Participant Flow|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
641809|NCT02334787|E8|Reported Event|Placebo Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
641783|NCT02334813|P1|Participant Flow|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
641784|NCT02334813|O2|Outcome|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
641785|NCT02334813|O1|Outcome|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
641786|NCT02334813|E2|Reported Event|Arm B: Pulsed Dexamethasone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm B patients subsequently receive six 21-day courses of pulsed dexamethasone (0.6 mg/kg/d, days 1-4).~Dexamethasone: 4-day pulses every 3 weeks"
641787|NCT02334813|E1|Reported Event|Arm A: Daily Prednisone|"During the first week of treatment patients in both arms receive prednisone at 1 mg/kg/d. In arm A prednisone is continued at 1 mg/kg/d for a second week. If platelets increase to ≥50/nl, its dose is reduced to <25 mg/d by week 14 and <7.5 mg/d by week 20 according to a step-wise reduction scheme provided in the protocol. In patients without response after 2 weeks of treatment, the prednisone dose is increased to 2 mg/kg/d for another 2 weeks, then tapered as described above.~Prednisone: Continuous daily therapy"
641788|NCT02334787|B5|Baseline|Total|Total of all reporting groups
641789|NCT02334787|B4|Baseline|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
641790|NCT02334787|B3|Baseline|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
641791|NCT02334787|B2|Baseline|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
641792|NCT02334787|B1|Baseline|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
641793|NCT02334787|P4|Participant Flow|Placebo|In a single administration period and the multiple administration period, same subjects were treated with assigned placebo ointment.
641794|NCT02334787|P3|Participant Flow|3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
641795|NCT02334787|P2|Participant Flow|1% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
641796|NCT02334787|P1|Participant Flow|0.3% OPA-15406 Ointment|In a single administration period and the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment.
641797|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641798|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641799|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641800|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
641801|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
641802|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
641803|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641804|NCT02334787|O2|Outcome|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641805|NCT02334787|O1|Outcome|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3％OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641806|NCT02334787|O3|Outcome|3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3% OPA-15406 ointment assessed until 48 hours postdose.
641807|NCT02334787|O2|Outcome|1% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1% OPA-15406 ointment assessed until 48 hours postdose.
641808|NCT02334787|O1|Outcome|0.3% OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned0.3％OPA-15406 ointment assessed until 48 hours postdose.
641810|NCT02334787|E7|Reported Event|3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641811|NCT02334787|E6|Reported Event|1 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 1 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641812|NCT02334787|E5|Reported Event|0.3 % OPA-15406 Ointment in the Multiple Administration Period|In the multiple administration period, same subjects were treated with assigned 0.3 % OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
641813|NCT02334787|E4|Reported Event|Placebo in a Single Adminstaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned placebo ointment.
641814|NCT02334787|E3|Reported Event|3% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 3% OPA-15406 ointment.
641815|NCT02334787|E2|Reported Event|1% OPA-15406 Ointment in a Single Administaration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single and administration period, same subjects were treated with assigned 1% OPA-15406 ointment.
641816|NCT02334787|E1|Reported Event|0.3 % OPA-15406 Ointment in a Single Administration Period|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment
641817|NCT02334267|B3|Baseline|Total|Total of all reporting groups
641818|NCT02334267|B2|Baseline|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
642050|NCT02330588|O5|Outcome|Move It (Normative Feedback)|
641819|NCT02334267|B1|Baseline|Group 1Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
641820|NCT02334267|P2|Participant Flow|Group 2 Week 1 NaturaLyte and Week 2 GranuFlo|"Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~NaturaLyte: Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
641821|NCT02334267|P1|Participant Flow|Group 1 Week 1 GranuFlo and Week 2 NaturaLyte|"Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments.~GranuFlow: Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: serum and dialysate samples will be obtained at specific timepoints during the dialysis treatments."
641822|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
641823|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic venous blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
641824|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
641825|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood acetate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
641826|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
641827|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic venous blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
642637|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
641828|NCT02334267|O2|Outcome|NaturaLyte|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte
641829|NCT02334267|O1|Outcome|GranuFlo|The outcome measure was peridialytic arterialized blood bicarbonate concentrations over time in subjects who received a hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo
641830|NCT02334267|E2|Reported Event|NaturaLyte|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate NaturaLyte.
641831|NCT02334267|E1|Reported Event|GranuFlo|The safety reporting group included subjects who received one study related hemodialysis treatment with a hemodialysate solution that was made from the acid dialysate concentrate GranuFlo.
641832|NCT02332902|B1|Baseline|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
641833|NCT02332902|P1|Participant Flow|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
641834|NCT02332902|O1|Outcome|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
641835|NCT02332902|O1|Outcome|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
641836|NCT02332902|E1|Reported Event|Intervention|"This is a single arm intervention using Everolimus.~Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2-week intervals to attain a trough concentration of 5-15 ng/mL."
641837|NCT02332798|B4|Baseline|Total|Total of all reporting groups
641838|NCT02332798|B3|Baseline|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641938|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641839|NCT02332798|B2|Baseline|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641840|NCT02332798|B1|Baseline|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641841|NCT02332798|P3|Participant Flow|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641842|NCT02332798|P2|Participant Flow|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641843|NCT02332798|P1|Participant Flow|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 milligram (mg) twice daily (BID) for 14 consecutive days with the last dose occurring in the morning on Day 14.
641844|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641845|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641846|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641847|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641848|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641849|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641850|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641851|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641852|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641853|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641854|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641855|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641856|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641857|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641858|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641859|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641860|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641861|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641862|NCT02332798|O3|Outcome|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
653791|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
641863|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641864|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641865|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641866|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641867|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641868|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641869|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641870|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641871|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641872|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641873|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641874|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641875|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641876|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641877|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641878|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641879|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641880|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641881|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641882|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641883|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641884|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641885|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641886|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641887|NCT02332798|O2|Outcome|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641888|NCT02332798|O1|Outcome|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641889|NCT02332798|E3|Reported Event|Placebo|All participants who received placebo BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641890|NCT02332798|E2|Reported Event|PF-04958242 0.475 mg|All participants who received PF-04958242 0.475 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641891|NCT02332798|E1|Reported Event|PF-04958242 0.25 mg|All participants who received PF-04958242 0.25 mg BID for 14 consecutive days with the last dose occurring in the morning on Day 14.
641892|NCT02331940|B3|Baseline|Total|Total of all reporting groups
641893|NCT02331940|B2|Baseline|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
641894|NCT02331940|B1|Baseline|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
641895|NCT02331940|P2|Participant Flow|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
641896|NCT02331940|P1|Participant Flow|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
642638|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
641897|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
641898|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
641899|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
641900|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
641901|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
641902|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
641903|NCT02331940|O2|Outcome|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
641937|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
642045|NCT02330588|O4|Outcome|Move It (Normative Feedback)|
641904|NCT02331940|O1|Outcome|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
641905|NCT02331940|E2|Reported Event|Respimat|"Tiotropium was delivered via the Respimat® Soft Mist Inhaler,~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Respimat: Inhalation via the Respimat once daily"
641906|NCT02331940|E1|Reported Event|Handihaler|"Tiotropium was delivered by the HandiHaler® device, a single-dose dry powder inhaler~tiotropium: Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.~Handihaler: Inhalation via the HandiHaler once daily"
641907|NCT02331589|B3|Baseline|Total|Total of all reporting groups
641908|NCT02331589|B2|Baseline|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
641909|NCT02331589|B1|Baseline|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
641910|NCT02331589|P2|Participant Flow|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
641911|NCT02331589|P1|Participant Flow|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
641912|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
641913|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
641914|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
641915|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
641916|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
641917|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
641918|NCT02331589|O2|Outcome|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
641919|NCT02331589|O1|Outcome|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
641920|NCT02331589|E2|Reported Event|Placebo (for KRG)|"placebo (for KRG) for 3 weeks~Placebo (for KRG): Placebos with same shape and size were manufactured and at Korea Ginseng Corporation"
641921|NCT02331589|E1|Reported Event|Korea Red Ginseng (KRG)|"KRG capsule (3,000 mg/day) for 3 weeks~KRG (Korea Red ginseng): 3 weeks of KRG capsule (3,000 mg/day)"
641922|NCT02331446|B5|Baseline|Total|Total of all reporting groups
641923|NCT02331446|B4|Baseline|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641924|NCT02331446|B3|Baseline|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641925|NCT02331446|B2|Baseline|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641926|NCT02331446|B1|Baseline|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
642639|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
641927|NCT02331446|P4|Participant Flow|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641928|NCT02331446|P3|Participant Flow|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641929|NCT02331446|P2|Participant Flow|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641930|NCT02331446|P1|Participant Flow|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641931|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641932|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641933|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641934|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641935|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641936|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641939|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641940|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641941|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641942|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641943|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641944|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641945|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641946|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641947|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641948|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641949|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641950|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641951|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641952|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641953|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641954|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641955|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641956|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641988|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641957|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641958|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641959|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641960|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641961|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641962|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641963|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641964|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641965|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641966|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641967|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641968|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641969|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641970|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641971|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641972|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641973|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641974|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641975|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641976|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641977|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641978|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641979|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641980|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641981|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641982|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641983|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641984|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641985|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641986|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641987|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
653858|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
641989|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641990|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641991|NCT02331446|O4|Outcome|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641992|NCT02331446|O3|Outcome|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641993|NCT02331446|O2|Outcome|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641994|NCT02331446|O1|Outcome|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641995|NCT02331446|E4|Reported Event|210 Minutes Per Week|"The group pf 210 minutes per week will do three sessions of 70 minutes per week, which consists on 35 minutes of aerobic exercise and 35 minutes of strength training.~Physical exercise intervention"
641996|NCT02331446|E3|Reported Event|150 Minutes Per Week|"The group of 150 minutes will do three sessions of 50 minutes per week, which consists on 25 minutes of aerobic exercise and 25 minutes of strength training.~Physical exercise intervention"
641997|NCT02331446|E2|Reported Event|90 Minutes Per Week|"The group of 90 minutes per week will do three sessions of 30 minutes per week of concurrent training, which consists on 15 minutes of aerobic exercise and 15 minutes of strength training.~Physical exercise intervention"
641998|NCT02331446|E1|Reported Event|Control|The control group will be oriented to maintain their normal activity and habits and will not receive the intervention.
641999|NCT02331108|B7|Baseline|Total|Total of all reporting groups
642000|NCT02331108|B6|Baseline|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642001|NCT02331108|B5|Baseline|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642002|NCT02331108|B4|Baseline|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642003|NCT02331108|B3|Baseline|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642004|NCT02331108|B2|Baseline|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642005|NCT02331108|B1|Baseline|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642006|NCT02331108|P6|Participant Flow|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642007|NCT02331108|P5|Participant Flow|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642008|NCT02331108|P4|Participant Flow|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642009|NCT02331108|P3|Participant Flow|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642010|NCT02331108|P2|Participant Flow|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642011|NCT02331108|P1|Participant Flow|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642640|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
653859|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
642012|NCT02331108|O2|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642013|NCT02331108|O1|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642014|NCT02331108|O6|Outcome|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642015|NCT02331108|O5|Outcome|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642016|NCT02331108|O4|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642017|NCT02331108|O3|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642018|NCT02331108|O2|Outcome|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642019|NCT02331108|O1|Outcome|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642020|NCT02331108|O6|Outcome|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642021|NCT02331108|O5|Outcome|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642022|NCT02331108|O4|Outcome|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642023|NCT02331108|O3|Outcome|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642024|NCT02331108|O2|Outcome|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642025|NCT02331108|O1|Outcome|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642026|NCT02331108|E6|Reported Event|Sevoflurane in 50% Nitrous, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642027|NCT02331108|E5|Reported Event|Sevoflurane in 100% Oxygen, Age >55|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age >55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642028|NCT02331108|E4|Reported Event|Propofol With Phenylephrine, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction 2.2 mg/kg propofol immediately preceded by 160 mcg intravenous phenylephrine. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642029|NCT02331108|E3|Reported Event|Propofol, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to intravenous induction with 2.2 mg/kg propofol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642326|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642030|NCT02331108|E2|Reported Event|Sevoflurane in 50% Nitrous, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 50% oxygen and 50% nitrous oxide. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642031|NCT02331108|E1|Reported Event|Sevoflurane in 100% Oxygen, Age <56|"The intervention will be the randomized selection of anesthetic induction technique to sevoflurane in 100% oxygen and temperatures will be recorded per protocol. Age 18-55.~Selection of anesthetic induction technique: Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes"
642032|NCT02330588|B6|Baseline|Total|Total of all reporting groups
642033|NCT02330588|B5|Baseline|eHealth Control Arm (Heads Up)|
642034|NCT02330588|B4|Baseline|Intervention Arm (Move It, Normative Feedback)|
642035|NCT02330588|B3|Baseline|Intervention Arm (Move It, Injunctive Feedback)|
642036|NCT02330588|B2|Baseline|Intervention Arm (Eat It, Normative Feedback)|
642037|NCT02330588|B1|Baseline|Intervention Arm (Eat It, Injunctive Feedback)|
642038|NCT02330588|P5|Participant Flow|eHealth Control|Parents randomly assigned to the control arm will include information on children's lifestyle behaviors only (no intervention questions).
642039|NCT02330588|P4|Participant Flow|Move It (Normative Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with normative feedback (i.e., referent data from Canadian children).
642040|NCT02330588|P3|Participant Flow|Move It (Injunctive Feedback)|Parents are presented with two questions about screen time and moderate-to-vigorous physical activity (MVPA); answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
642041|NCT02330588|P2|Participant Flow|Eat It (Normative Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with normative feedback (i.e., referent data from Canadian children).
642042|NCT02330588|P1|Participant Flow|Eat It (Injunctive Feedback)|Parents are presented with two questions about portion size and sugar-sweetened beverages; answers are contrasted with injunctive feedback (i.e., Canadian guidelines).
642043|NCT02330588|O6|Outcome|All Groups (Total)|
642044|NCT02330588|O5|Outcome|Heads Up (eHealth Control)|
642051|NCT02330588|O4|Outcome|Move It (Injunctive Feedback)|
642052|NCT02330588|O3|Outcome|Eat It (Normative Feedback)|
642053|NCT02330588|O2|Outcome|Eat It (Injunctive Feedback)|
642054|NCT02330588|O1|Outcome|Feasibility (Uptake)|All groups (brief intervention + eHealth control)
642055|NCT02330588|O6|Outcome|eHealth Control|
642056|NCT02330588|O5|Outcome|Move It (Normative Feedback)|
642057|NCT02330588|O4|Outcome|Move It (Injunctive Feedback)|
642058|NCT02330588|O3|Outcome|Eat It (Normative Feedback)|
642059|NCT02330588|O2|Outcome|Eat It (Injunctive Feedback)|
642060|NCT02330588|O1|Outcome|All Groups (Total)|All groups (four brief interventions + eHealth control)
642061|NCT02330588|E5|Reported Event|eHealth Control|
642062|NCT02330588|E4|Reported Event|Move It (Normative)|
642063|NCT02330588|E3|Reported Event|Move It (Injunctive)|
642064|NCT02330588|E2|Reported Event|Eat It (Normative)|
642065|NCT02330588|E1|Reported Event|Eat It (Injunctive)|
642066|NCT02330523|B3|Baseline|Total|Total of all reporting groups
642067|NCT02330523|B2|Baseline|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642068|NCT02330523|B1|Baseline|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642069|NCT02330523|P2|Participant Flow|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642081|NCT02330276|B2|Baseline|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642327|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642070|NCT02330523|P1|Participant Flow|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642071|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642072|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642073|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642291|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
642074|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642075|NCT02330523|O2|Outcome|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642076|NCT02330523|O1|Outcome|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642077|NCT02330523|E2|Reported Event|Xenograft + Non-x-link Collagen|"Xenograft + non-x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642078|NCT02330523|E1|Reported Event|Allograft + X-link Collagen Membrane|"Demineralized freeze-dried allograft + x-linked collagen membrane will be used for guided bone regeneration of dehiscence buccal defects post extraction.~Guided Bone Regeneration: Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Test graft materials will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. The membranes will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0."
642079|NCT02330276|B4|Baseline|Total|Total of all reporting groups
642080|NCT02330276|B3|Baseline|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642328|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
653860|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
642082|NCT02330276|B1|Baseline|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642083|NCT02330276|P3|Participant Flow|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642084|NCT02330276|P2|Participant Flow|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642085|NCT02330276|P1|Participant Flow|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642086|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642292|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642742|NCT02319148|O3|Outcome|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
642087|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642088|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642089|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642090|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642091|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642092|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642093|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642094|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642095|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642283|NCT02329015|B1|Baseline|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
642096|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642097|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642098|NCT02330276|O3|Outcome|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642099|NCT02330276|O2|Outcome|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642100|NCT02330276|O1|Outcome|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642101|NCT02330276|E3|Reported Event|100 mg (+)-Epicatechin|"4 subjects randomized to one dose of 100 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642102|NCT02330276|E2|Reported Event|30 mg (+)-Epicatechin|"4 subjects randomized to one dose of 30 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642103|NCT02330276|E1|Reported Event|10 mg (+)-Epicatechin|"4 subjects randomized to one dose of 10 mg (+)-epicatechin taken orally~(+)-Epicatechin: The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included."
642104|NCT02330172|B3|Baseline|Total|Total of all reporting groups
642105|NCT02330172|B2|Baseline|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642106|NCT02330172|B1|Baseline|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642107|NCT02330172|P2|Participant Flow|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642108|NCT02330172|P1|Participant Flow|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642109|NCT02330172|O2|Outcome|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642284|NCT02329015|P2|Participant Flow|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642110|NCT02330172|O1|Outcome|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642111|NCT02330172|O2|Outcome|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642112|NCT02330172|O1|Outcome|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642113|NCT02330172|E2|Reported Event|Rocuronium 0.9 - Sugammadex|"When anesthetic induction, rocuronium 0.9 mg/kg will be injected to rocuronium 0.9 - sugammadex group for muscle relaxation.~When the end of operation,, a injection of neostigmine or sugammadex be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
645423|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
642114|NCT02330172|E1|Reported Event|Rocuronium 0.45 - Neostigmine|"when anesthetic induction, inrocuronium 0.45 mg/kg will be administered for muscle relaxation.~When the end of operation, a injection of neostigmine or sugammadex will be administered.~Injection of neostigmine or sugammadex: At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
642115|NCT02329964|B3|Baseline|Total|Total of all reporting groups
642116|NCT02329964|B2|Baseline|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642117|NCT02329964|B1|Baseline|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642118|NCT02329964|P2|Participant Flow|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642119|NCT02329964|P1|Participant Flow|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642120|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642121|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642122|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642123|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642329|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642641|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
653861|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
642124|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642125|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642126|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642127|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642293|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
642294|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642128|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642129|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642130|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642131|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642132|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642133|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642134|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642135|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642136|NCT02329964|O2|Outcome|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642137|NCT02329964|O1|Outcome|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642138|NCT02329964|E2|Reported Event|S-C-N Group|"Succinylcholine-Cisatracurium-Neostigmine group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Succinylcholine 1mg/kg~After endotracheal intubation,~Cisatracurium 0.08mg/kg~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Succinylcholine 10mg~Relaxant agent reversal. at the appearance of second TOF twitch (T2).~Neostigmine 0.2 mg/kg with atropine 10μg/kg (for preventing side effects of neostigmine)"
642139|NCT02329964|E1|Reported Event|R-S Group|"Rocuronium-Sugammadex group~Induction agent :~IV Propofol 1.5-2.5 mg/Kg and fentanyl 1.5mcg/kg~During induction of anesthesia, as muscle relaxant agent~Rocuronium 1mg/kg~After endotracheal intubation~normal saline(0.025 ml/kg)~Additive dose, for ensuring that neuromuscular blockade remains below T2 during surgery~Rocuronium 0.15mg/kg~Relaxant agent reversal. at the the end of surgery.~sugammadex 2mg/kg"
642140|NCT02329730|B5|Baseline|Total|Total of all reporting groups
642141|NCT02329730|B4|Baseline|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642142|NCT02329730|B3|Baseline|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642348|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642143|NCT02329730|B2|Baseline|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642144|NCT02329730|B1|Baseline|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642145|NCT02329730|P12|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
642146|NCT02329730|P11|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
642147|NCT02329730|P10|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
642148|NCT02329730|P9|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & Placebo|"The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and placebo of ESAT6-CFP10 only one time .Right arm inject ESAT6-CFP10 and left arm inject placebo. Two drugs must be use in the same subjects.~Left arm intradermal injection of the placebo of ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in same tuberculosis subjects."
642149|NCT02329730|P8|Participant Flow|Tuberculosis Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
642150|NCT02329730|P7|Participant Flow|Tuberculosis Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
642151|NCT02329730|P6|Participant Flow|Tuberculosis Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
642152|NCT02329730|P5|Participant Flow|Tuberculosis Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every subjects ."
642330|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642153|NCT02329730|P4|Participant Flow|Healthy Subjects-20μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 20μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
642154|NCT02329730|P3|Participant Flow|Healthy Subjects-10μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 10μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
642155|NCT02329730|P2|Participant Flow|Healthy Subjects-5μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 5μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject respectively ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
642349|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642156|NCT02329730|P1|Participant Flow|Healthy Subjects-1μg/ml ESAT6-CFP10 & TB-PPD|"The same healthy subjects inject 1μg/ml ESAT6-CFP10 and TB-PPD only one time .Right arm inject ESAT6-CFP10 and left arm TB-PPD.Two drugs must be use in the same subjects.~Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal inject ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and TB-PPD only one time in every healthy subjects ."
642157|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642158|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642159|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642160|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642161|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642162|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642163|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642164|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642165|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642642|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
642166|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642167|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642295|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
648000|NCT02255279|B3|Baseline|Total|Total of all reporting groups
642168|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642169|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642170|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642171|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642172|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642173|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642174|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642175|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642176|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642177|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642285|NCT02329015|P1|Participant Flow|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
642643|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
642178|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642179|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642180|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642181|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642182|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642183|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642184|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642185|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642186|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642187|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642188|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642189|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642286|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642331|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo (Biodal 50,000 IU): 50.000IU Vitamin D3 (Biodal 50.000IU ) placebo once weekly for 3 months"
642645|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
642190|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642191|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642192|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642193|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642194|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642195|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642196|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642197|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642198|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642199|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642200|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642201|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642287|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
642646|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
642202|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642203|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642204|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642205|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642206|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642207|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642208|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642209|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642210|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642211|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642212|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642213|NCT02329730|O4|Outcome|20μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642288|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642332|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
653862|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
642214|NCT02329730|O3|Outcome|10μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642215|NCT02329730|O2|Outcome|5μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642216|NCT02329730|O1|Outcome|1μg/ml ESAT6-CFP10|The healthy subjects and TB subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) or the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD or the placebo .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml) or the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 or the placebo of ESAT6-CFP10 by a syringe(1ml).
642217|NCT02329730|E12|Reported Event|Tuberculosis Subjects- 20μg/ml EC and Placebo|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642218|NCT02329730|E11|Reported Event|Tuberculosis Subjects- 10μg/ml EC and Placebo|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642219|NCT02329730|E10|Reported Event|Tuberculosis Subjects- 5μg/ml EC and Placebo|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642220|NCT02329730|E9|Reported Event|Tuberculosis Subjects- 1μg/ml EC and Placebo|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and the placebo of ESAT6-CFP10 only one time in the different time .Right arm inject ESAT6-CFP10 and left arm the placebo.Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml the placebo by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642221|NCT02329730|E8|Reported Event|Tuberculosis Subjects- 20μg/ml EC and TB-PPD|The tuberculosis subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642222|NCT02329730|E7|Reported Event|Tuberculosis Subjects- 10μg/ml EC and TB-PPD|The tuberculosis subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642223|NCT02329730|E6|Reported Event|Tuberculosis Subjects- 5μg/ml EC and TB-PPD|The tuberculosis subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642224|NCT02329730|E5|Reported Event|Tuberculosis Subjects- 1μg/mlEC and TB-PPD|The tuberculosis subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642225|NCT02329730|E4|Reported Event|Healthy Subjects-20μg/ml EC and TB-PPD|The healthy subjects inject 20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642226|NCT02329730|E3|Reported Event|Healthy Subjects-10μg/ml EC and TB-PPD|The healthy subjects inject 10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642227|NCT02329730|E2|Reported Event|Healthy Subjects-5μg/ml EC and TB-PPD|The healthy subjects inject 5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642647|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
642228|NCT02329730|E1|Reported Event|Healthy Subjects-1μg/ml ECand TB-PPD|The healthy subjects inject 1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative (TB-PPD) only one time in the different time .Right arm inject ESAT6-CFP10 and left arm inject TB-PPD .Two drugs must be use in the same subjects. Left arm intradermally inject with 0.1ml TB-PPD(50IU/ml)by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermally inject with 0.1ml ESAT6-CFP10 by a syringe(1ml).
642229|NCT02329600|B4|Baseline|Total|Total of all reporting groups
642296|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642297|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
645424|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
642230|NCT02329600|B3|Baseline|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642231|NCT02329600|B2|Baseline|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642232|NCT02329600|B1|Baseline|Control Subjects|10 systemically healthy control subjects taking no medication.
642233|NCT02329600|P3|Participant Flow|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642234|NCT02329600|P2|Participant Flow|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642235|NCT02329600|P1|Participant Flow|Control Subjects|10 systemically healthy control subjects taking no medication.
642236|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642237|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642238|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
642239|NCT02329600|O3|Outcome|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642240|NCT02329600|O2|Outcome|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642241|NCT02329600|O1|Outcome|Control Subjects|10 systemically healthy control subjects taking no medication.
642289|NCT02329015|O1|Outcome|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
642290|NCT02329015|O2|Outcome|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
653863|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
642298|NCT02329015|E2|Reported Event|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642299|NCT02329015|E1|Reported Event|Health and Wellness Program|"Behavioral intervention~Yoga-informed Health and Wellness Program: The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June)."
642300|NCT02328937|B1|Baseline|Overall|All subjects that were dispensed at least one study lens.
642242|NCT02329600|E3|Reported Event|OLP and Corticosteroid and Green Tea|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with both topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month in addition to green tea tablets 200 mg (Green tea extract 5:1, El Obour For Modern Pharmaceutical Industries) as one tablet a day also for one month.~green tea tablets (Green tea extract 5:1) 200 mg: Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642243|NCT02329600|E2|Reported Event|OLP and Corticosteroid|"15 Patients who were previously diagnosed with oral lichen planus presented in acute exacerbation were treated with topical corticosteroids; Triamcinolone acetonide (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month.~Triamcinolone Acetonide: topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month"
642244|NCT02329600|E1|Reported Event|Control Subjects|10 systemically healthy control subjects taking no medication.
642245|NCT02329223|B4|Baseline|Total|Total of all reporting groups
642246|NCT02329223|B3|Baseline|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642247|NCT02329223|B2|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642248|NCT02329223|B1|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642249|NCT02329223|P3|Participant Flow|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642250|NCT02329223|P2|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642251|NCT02329223|P1|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642252|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642253|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642254|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642255|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642256|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642257|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642258|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642259|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642260|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642261|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642262|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642263|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642264|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642265|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642266|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642267|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642268|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642269|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642270|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642271|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642272|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642273|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642274|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642275|NCT02329223|O3|Outcome|Placebo|Participants will receive placebo subcutaneously every 4 weeks during the 12 week treatment period.
642276|NCT02329223|O2|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 12 week treatment period.
642277|NCT02329223|O1|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 12 week treatment period.
642278|NCT02329223|E3|Reported Event|Placebo|Placebo
642279|NCT02329223|E2|Reported Event|IGE025 150 mg|IGE025 150 mg
642280|NCT02329223|E1|Reported Event|IGE025 300 mg|IGE025 300 mg
642281|NCT02329015|B3|Baseline|Total|Total of all reporting groups
642282|NCT02329015|B2|Baseline|Physical Education Class|"Behavioral intervention~Physical Education Class: Standard physical education"
642333|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642301|NCT02328937|P6|Participant Flow|Comfilcon A/Lotrafilcon B/Etafilcon A|Subjects randomized to this sequence received comfilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received etafilcon A during the last period.
642302|NCT02328937|P5|Participant Flow|Comfilcon A/Etafilcon A/Lotrafilcon B|Subjects randomized to this sequence received comfilcon A during the 1st period, then received etafilcon A during the 2nd period, and then received lotrafilcon B during the last period.
642303|NCT02328937|P4|Participant Flow|Lotrafilcon B/Comfilcon A/Etafilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received comfilcon A during the 2nd period, and then received etafilcon A during the last period.
642304|NCT02328937|P3|Participant Flow|Lotrafilcon B/Etafilcon A/Comfilcon A|Subjects randomized to this sequence received lotrafilcon B during the 1st period, then received etafilcon A during the 2nd period, and then received comfilcon A during the last period.
642305|NCT02328937|P2|Participant Flow|Etafilcon A/Comfilcon A/Lotrafilcon B|Subjects randomized to this sequence received etafilcon A during the 1st period, then received comfilcon A during the 2nd period, and then received lotrafilcon B during the last period.
642306|NCT02328937|P1|Participant Flow|Etafilcon A/Lotrafilcon B/Comfilcon A|Subjects randomized to this sequence received etafilcon A during the 1st period, then received lotrafilcon B during the 2nd period, and then received comfilcon A during the last period.
642307|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
642308|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
642309|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
642310|NCT02328937|O3|Outcome|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
642311|NCT02328937|O2|Outcome|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
642312|NCT02328937|O1|Outcome|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
642313|NCT02328937|E3|Reported Event|Comfilcon A|Subjects that wore the comfilcon A lens during any of the 3 period over the course of this study.
642314|NCT02328937|E2|Reported Event|Lotrafilcon B|Subjects that wore the lotrafilcon B lens during any of the 3 period over the course of this study.
642315|NCT02328937|E1|Reported Event|Etafilcon A|Subjects that wore the etafilcon A lens during any of the 3 period over the course of this study.
642316|NCT02328404|B3|Baseline|Total|Total of all reporting groups
642317|NCT02328404|B2|Baseline|Placebo (Biodal 50,000IU Placebo)|"Placebo (Biodal 50,000IU Placebo tablets) coated tablets by oral route~Placebo: 50,000IU Vitamin D3 placebo (Biodal 50,000IU placebo) once weekly for 3 months"
642318|NCT02328404|B1|Baseline|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642319|NCT02328404|P2|Participant Flow|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642320|NCT02328404|P1|Participant Flow|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642321|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642322|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642323|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642324|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642325|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642648|NCT02320695|E1|Reported Event|OVERALL|This includes all 60 randomized subjects.
642334|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642335|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642336|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642337|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642338|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50.000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642339|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642340|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50.000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642341|NCT02328404|O2|Outcome|Placebo|"Placebo coated tablet by oral route~Placebo: placebo coated tablet by oral route"
642342|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642343|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642344|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642345|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642346|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642347|NCT02328404|O2|Outcome|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642350|NCT02328404|O1|Outcome|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642351|NCT02328404|E2|Reported Event|Placebo|"placebo coated tablet by oral route~placebo: placebo coated tablet by oral route"
642352|NCT02328404|E1|Reported Event|Vitamin D3 (Biodal 50,000IU)|"50,000 IU vitamin D3 (Biodal 50,000IU) coated tablets by oral route~50,000IU Vitamin D3: 50,000IU Vitamin D3 (Biodal 50,000IU ) once weekly for 3 months"
642353|NCT02327117|B3|Baseline|Total|Total of all reporting groups
642354|NCT02327117|B2|Baseline|Normal Saline|Normal saline
642355|NCT02327117|B1|Baseline|Tranexamic Acid|Tranexamic Acid
642356|NCT02327117|P2|Participant Flow|Normal Saline|Normal saline
642357|NCT02327117|P1|Participant Flow|Tranexamic Acid|Tranexamic Acid
642358|NCT02327117|O2|Outcome|Normal Saline|Normal saline
642359|NCT02327117|O1|Outcome|Tranexamic Acid|Tranexamic Acid
642360|NCT02327117|E2|Reported Event|Normal Saline|Normal saline
642361|NCT02327117|E1|Reported Event|Tranexamic Acid|Tranexamic Acid
642362|NCT02326844|B1|Baseline|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
642363|NCT02326844|P1|Participant Flow|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
642364|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
642365|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
642366|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
642367|NCT02326844|O1|Outcome|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
642368|NCT02326844|E1|Reported Event|Ovarian Cancer Patients|Ovarian cancer patients with germline breast cancer mutation (gBRCAm) who have progressed on prior poly (ADP-ribose) polymerase inhibitor (PARPi) therapy BMN 673 (talazoparib): 1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
642369|NCT02326649|B1|Baseline|Diagnosis, Age, and Body Size of Subjects|Overall
642370|NCT02326649|P1|Participant Flow|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
642371|NCT02326649|O1|Outcome|SMIC and CMR|Participants with various congenital heart disease diagnoses with both signal-morphology IC (SMIC) measurements and cardiac magnetic resonance (CMR) imaging
642372|NCT02326649|E1|Reported Event|CHD Patients Undergoing Cardiac MRI Without Sedation|Physioflow: impedance cardiography instrument that measures cardiac output non-invasively
642373|NCT02325856|B3|Baseline|Total|Total of all reporting groups
642374|NCT02325856|B2|Baseline|Control Group|Dry weight determined by clinical symptoms
642649|NCT02320396|B3|Baseline|Total|Total of all reporting groups
642375|NCT02325856|B1|Baseline|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
642376|NCT02325856|P2|Participant Flow|Control Group|Dry weight determined by clinical symptoms
642377|NCT02325856|P1|Participant Flow|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
642378|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
642379|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
642380|NCT02325856|O2|Outcome|Control Group|Dry weight determined by clinical symptoms
642381|NCT02325856|O1|Outcome|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
642382|NCT02325856|E2|Reported Event|Control Group|Dry weight determined by clinical symptoms
642383|NCT02325856|E1|Reported Event|Study Group|"Dry weight determined by performing Bioimpedance Spectroscopy (intervention is the performance of this tool)~Bioimpedance Spectroscopy: Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients."
642384|NCT02325713|B17|Baseline|Total|Total of all reporting groups
642385|NCT02325713|B16|Baseline|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642743|NCT02319148|O2|Outcome|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
642386|NCT02325713|B15|Baseline|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642387|NCT02325713|B14|Baseline|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642388|NCT02325713|B13|Baseline|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642389|NCT02325713|B12|Baseline|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642390|NCT02325713|B11|Baseline|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642391|NCT02325713|B10|Baseline|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642432|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642644|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
642392|NCT02325713|B9|Baseline|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642393|NCT02325713|B8|Baseline|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642394|NCT02325713|B7|Baseline|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642441|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642442|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
648928|NCT02246114|B1|Baseline|Arm A|no CO monitor
642395|NCT02325713|B6|Baseline|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642396|NCT02325713|B5|Baseline|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642397|NCT02325713|B4|Baseline|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642398|NCT02325713|B3|Baseline|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642399|NCT02325713|B2|Baseline|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642400|NCT02325713|B1|Baseline|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642401|NCT02325713|P16|Participant Flow|Sequence B-A-D2-C2|Subjects randomized to treatment sequence B-A-D2-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642576|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642402|NCT02325713|P15|Participant Flow|Sequence B-A-D1-C2|Subjects randomized to treatment sequence B-A-D1-C2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642403|NCT02325713|P14|Participant Flow|Sequence B-A-D2-C1|Subjects randomized to treatment sequence B-A-D2-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642404|NCT02325713|P13|Participant Flow|Sequence B-A-D1-C1|Subjects randomized to treatment sequence B-A-D1-C1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642405|NCT02325713|P12|Participant Flow|Sequence B-A-C2-D2|Subjects randomized to treatment sequence B-A-C2-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642406|NCT02325713|P11|Participant Flow|Sequence B-A-C2-D1|Subjects randomized to treatment sequence B-A-C2-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642407|NCT02325713|P10|Participant Flow|Sequence B-A-C1-D2|Subjects randomized to treatment sequence B-A-C1-D2 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642408|NCT02325713|P9|Participant Flow|Sequence B-A-C1-D1|Subjects randomized to treatment sequence B-A-C1-D1 received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in first intervention period and then a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642409|NCT02325713|P8|Participant Flow|Sequence A-B-D2-C2|Subjects randomized to treatment sequence A-B-D2-C2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642410|NCT02325713|P7|Participant Flow|Sequence A-B-D1-C2|Subjects randomized to treatment sequence A-B-D1-C2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642411|NCT02325713|P6|Participant Flow|Sequence A-B-D2-C1|Subjects randomized to treatment sequence A-B-D2-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642577|NCT02322775|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks
642412|NCT02325713|P5|Participant Flow|Sequence A-B-D1-C1|Subjects randomized to treatment sequence A-B-D1-C1 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in third intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642413|NCT02325713|P4|Participant Flow|Sequence A-B-C2-D2|Subjects randomized to treatment sequence A-B-C2-D2 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642414|NCT02325713|P3|Participant Flow|Sequence A-B-C2-D1|Subjects randomized to treatment sequence A-B-C2-D1 received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C2) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642415|NCT02325713|P2|Participant Flow|Sequence A-B-C1-D2|Subjects randomized to treatment sequence A-B-C1-D2 received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal (Treatment D2) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642416|NCT02325713|P1|Participant Flow|Sequence A-B-C1-D1|Subjects randomized to treatment sequence A-B-C1-D1 received a single oral dose of 40 milligram per kilogram (40 mg/kg) of test oral dispersible tablet of praziquantel (ODT-PZQ) dispersed in water after a meal (Treatment A) in first intervention period and then reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal (Treatment B) in second intervention period and then a single oral dose 20 mg/kg of test ODT-PZQ dispersed in water after a meal (Treatment C1) in third intervention period and then a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal (Treatment D1) in fourth intervention period. A washout period of 7 days was maintained between each intervention period.
642417|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642418|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642419|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642420|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642421|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642422|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642423|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642424|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642425|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642426|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642427|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642428|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642429|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642430|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642431|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642730|NCT02319148|B4|Baseline|Total|Total of all reporting groups
642433|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642434|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642435|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642436|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642437|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642438|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642439|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642440|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642744|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642443|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642444|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642445|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642446|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642447|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642448|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642449|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642450|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642451|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642452|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642453|NCT02325713|O1|Outcome|PZQ 40 mg/kg (Treatment A and Treatment B)|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal and reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642454|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642455|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642456|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642457|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642458|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642459|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642460|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642461|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642462|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642463|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642464|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642465|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642466|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642467|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642468|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642469|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642470|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642471|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642472|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642473|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642474|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642475|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642476|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642477|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642478|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642479|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642480|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642481|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642482|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642483|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642484|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642485|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642486|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642487|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642488|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642489|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642490|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642491|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642492|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
653864|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
642493|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642494|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642495|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642496|NCT02325713|O6|Outcome|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642497|NCT02325713|O5|Outcome|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642498|NCT02325713|O4|Outcome|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642499|NCT02325713|O3|Outcome|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642500|NCT02325713|O2|Outcome|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642501|NCT02325713|O1|Outcome|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642502|NCT02325713|E6|Reported Event|Treatment D2: 40 mg/kg Cysticide Crushed Tablets After Meal|Subjects who received reference PZQ formulation (Cysticide crushed tablets) at a single dose of 40 mg/kg given with water orally after a meal in either of the four intervention periods.
642503|NCT02325713|E5|Reported Event|Treatment D1: 40 mg/kg Test ODT-PZQ Without Meal|Subjects who received a single oral dose 40 mg/kg of test ODT-PZQ dispersed in water without a meal in either of the four intervention periods.
642504|NCT02325713|E4|Reported Event|Treatment C2: 60 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose 60 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642505|NCT02325713|E3|Reported Event|Treatment C1: 20 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 20 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642506|NCT02325713|E2|Reported Event|Treatment B: 40 mg/kg Cysticide Tablet After Meal|Subjects who received reference PZQ formulation (Cysticide tablet) at a single dose of 40 mg/kg given with water orally after a meal either of the four intervention periods.
642507|NCT02325713|E1|Reported Event|Treatment A: 40 mg/kg Test ODT-PZQ After Meal|Subjects who received a single oral dose of 40 mg/kg of test ODT-PZQ dispersed in water after a meal in either of the four intervention periods.
642508|NCT02325518|B3|Baseline|Total|Total of all reporting groups
642509|NCT02325518|B2|Baseline|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642510|NCT02325518|B1|Baseline|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642511|NCT02325518|P2|Participant Flow|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642512|NCT02325518|P1|Participant Flow|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual prostaglandin-analog (PGA) monotherapy, 1 drop in each eye once daily for 8 weeks.
642513|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642514|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642515|NCT02325518|O2|Outcome|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642516|NCT02325518|O1|Outcome|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642517|NCT02325518|E3|Reported Event|DOR/TIM|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642518|NCT02325518|E2|Reported Event|BRI/TIM|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension, 1 drop in each eye twice daily, and habitual PGA monotherapy, 1 drop in each eye once daily for 8 weeks.
642519|NCT02325518|E1|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
642520|NCT02322892|B3|Baseline|Total|Total of all reporting groups
642521|NCT02322892|B2|Baseline|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642522|NCT02322892|B1|Baseline|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642523|NCT02322892|P2|Participant Flow|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642524|NCT02322892|P1|Participant Flow|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642578|NCT02322775|E1|Reported Event|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642525|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642526|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642527|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642528|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642529|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642530|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642531|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642532|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642533|NCT02322892|O2|Outcome|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642534|NCT02322892|O1|Outcome|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642780|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642535|NCT02322892|E2|Reported Event|Thiamine|"200 mg thiamine in 50 mL normal saline solution~Thiamine: 200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642536|NCT02322892|E1|Reported Event|Control Arm|"50 mL normal saline solution~Normal saline solution: 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)"
642537|NCT02322788|B1|Baseline|Overall|Total number of participants in the Full analysis set
642538|NCT02322788|P4|Participant Flow|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
642539|NCT02322788|P3|Participant Flow|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
642540|NCT02322788|P2|Participant Flow|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
642541|NCT02322788|P1|Participant Flow|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
642542|NCT02322788|O4|Outcome|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
642543|NCT02322788|O3|Outcome|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
642544|NCT02322788|O2|Outcome|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
642545|NCT02322788|O1|Outcome|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
642546|NCT02322788|E4|Reported Event|M3 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M3
642547|NCT02322788|E3|Reported Event|M3 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M3
642548|NCT02322788|E2|Reported Event|M2 1.5 mg|1.5 mg terbutaline sulphate administered via Turbuhaler M2
642549|NCT02322788|E1|Reported Event|M2 0.5 mg|0.5 mg terbutaline sulphate administered via Turbuhaler M2
642550|NCT02322775|B3|Baseline|Total|Total of all reporting groups
642551|NCT02322775|B2|Baseline|Placebo|Placebo administered subcutaneously every 4 weeks
642552|NCT02322775|B1|Baseline|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642553|NCT02322775|P2|Participant Flow|Placebo|Placebo administered subcutaneously every 4 weeks
642554|NCT02322775|P1|Participant Flow|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642555|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642556|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642557|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642558|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642559|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642560|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642561|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642562|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642563|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642564|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642565|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642566|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642567|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642568|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642569|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642570|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642571|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642572|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642573|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642574|NCT02322775|O1|Outcome|Benralizumab 30 mg Q4W|Benralizumab administered subcutaneously every 4 weeks
642575|NCT02322775|O2|Outcome|Placebo|Placebo administered subcutaneously every 4 weeks
642579|NCT02322749|B1|Baseline|Overall Study|All subjects received at least 1 dose of selumetinib. Subjects were randomised in a crossover fashion to receive 1 of 3 treatments during each treatment period: Period 1=Visit 2; Period 2=Visit 3; Period 3=Visit 4.
642580|NCT02322749|P6|Participant Flow|Sequence CBA|Subjects randomized to treatment sequences CBA: C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
642581|NCT02322749|P5|Participant Flow|Sequence CAB|Subjects randomized to treatment sequences CAB: C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
642582|NCT02322749|P4|Participant Flow|Sequence BCA|Subjects randomized to treatment sequences BCA: B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules; A=Selumetinib Blue Reference Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
642583|NCT02322749|P3|Participant Flow|Sequence BAC|Subjects randomized to treatment sequences BAC: B=Selumetinib Blue Free Base Variant Capsules; A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
642584|NCT02322749|P2|Participant Flow|Sequence ACB|Subjects randomized to treatment sequences ACB: A=Selumetinib Blue Reference Capsules; C=Selumetinib Blue TPGS Variant Capsules; B=Selumetinib Blue Free Base Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
642585|NCT02322749|P1|Participant Flow|Sequence ABC|Subjects randomized to treatment sequences ABC: A=Selumetinib Blue Reference Capsules; B=Selumetinib Blue Free Base Variant Capsules; C=Selumetinib Blue TPGS Variant Capsules. Subjects received 75 mg selumetinib (3 x 25 mg capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration) in a crossover fashion. There was a washout period of 7-10 days between administrations.
642586|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642587|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642588|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642589|NCT02322749|O3|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642590|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642591|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642592|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642593|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642594|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642595|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642596|NCT02322749|O2|Outcome|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642597|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642634|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
642598|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642599|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642600|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642601|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642602|NCT02322749|O2|Outcome|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642603|NCT02322749|O1|Outcome|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642604|NCT02322749|E3|Reported Event|Treatment C: Selumetinib Blue TPGS Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg vitamin E polyethylene glycol succinate [TPGS] variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
643264|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
642605|NCT02322749|E2|Reported Event|Treatment B: Selumetinib Blue Free Base Variant Capsules|Subjects received 75 mg selumetinib (3 x 25 mg free base variant capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642606|NCT02322749|E1|Reported Event|Treatment A: Selumetinib Blue Reference Capsules|Subjects received 75 mg selumetinib (3 x 25 mg blue reference capsules) administered as a single oral dose on Day 1 of each period according to their treatment sequence under fasted conditions (10 hours prior to administration).
642607|NCT02322528|B1|Baseline|Administration of Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
642608|NCT02322528|P1|Participant Flow|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
642609|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
642610|NCT02322528|O1|Outcome|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
642611|NCT02322528|E1|Reported Event|Administration of 0.5% Lotemax|An FDA approved drug (Lotemax) will be administered to both eyes to induce an inflammatory mediated response.
642612|NCT02322216|B3|Baseline|Total|Total of all reporting groups
642613|NCT02322216|B2|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
642614|NCT02322216|B1|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
642615|NCT02322216|P2|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
642616|NCT02322216|P1|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
642617|NCT02322216|O2|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution 0.1%, 1 drop in each eye in the morning and evening, for 14 days
642618|NCT02322216|O1|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution 0.2% in the morning and olopatadine 0.2% Vehicle in the evening, 1 drop in each eye for 14 days
642619|NCT02322216|E3|Reported Event|PATANOL|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.1%
642620|NCT02322216|E2|Reported Event|PATADAY|All subjects treated with olopatadine hydrochloride ophthalmic solution 0.2%
642621|NCT02322216|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
642622|NCT02320695|B1|Baseline|OVERALL|This includes all 60 randomized subjects. Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
642623|NCT02320695|P1|Participant Flow|OVERALL|Subjects were assigned to each of the following interventions: Saline, Isopropyl Alcohol, Neosporin Plus Pain Relieving Cream, Neosporin Complete First Aid Antibiotic/Pain Relieving Ointment, Neosporin Original Ointment, Neosporin Plus Pain Relief Ointment. The sequence in which participants received the intervention was randomized.
642624|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
642625|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
642626|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
642627|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
642628|NCT02320695|O2|Outcome|Isopropyl Alcohol|70% Isopropyl Alcohol (0.3 cc)
642629|NCT02320695|O1|Outcome|Saline|0.9% Sodium Chloride Saline Solution (0.3 cc)
642630|NCT02320695|O6|Outcome|Pain Relief Ointment|Neosporin® Plus Pain relief Ointment (0.3 cc)
642631|NCT02320695|O5|Outcome|Original Ointment|Neosporin® Original Ointment (0.3 cc)
642632|NCT02320695|O4|Outcome|Antibiotic/Pain Relieving Ointment|Neosporin® Complete First Aid Antibiotic/Pain Relieving Ointment (0.3 cc)
642633|NCT02320695|O3|Outcome|Pain Relieving Cream|Neosporin® Plus Pain Relieving Cream formula with pH balance technology (0.3 cc)
642650|NCT02320396|B2|Baseline|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642651|NCT02320396|B1|Baseline|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642652|NCT02320396|P2|Participant Flow|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642653|NCT02320396|P1|Participant Flow|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642654|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642655|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642656|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
643265|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
642657|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642658|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642659|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642660|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642661|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642662|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642663|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642664|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642665|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642666|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642667|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642668|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642669|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642670|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642671|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642672|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642673|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642674|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642731|NCT02319148|B3|Baseline|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642675|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642676|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642677|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642678|NCT02320396|O2|Outcome|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642679|NCT02320396|O1|Outcome|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642680|NCT02320396|E2|Reported Event|Placebo|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded placebo (one tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642740|NCT02319148|O5|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642681|NCT02320396|E1|Reported Event|Desloratadine|After a 1-week single-blinded placebo run-in during which SAR symptoms are confirmed (Confirmation of Symptom Period), participants receive double-blinded desloratadine (one 5 mg tablet) PO QD in the morning for 2 weeks during the Treatment Period.
642682|NCT02320227|B1|Baseline|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
642683|NCT02320227|P1|Participant Flow|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
642684|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks.
642685|NCT02320227|O1|Outcome|Miami w/o Frag Personal Lubricant|Healthy subjects use Miami w/o frag Personal lubricant at least 4 times per week for 2 weeks
642686|NCT02320227|E1|Reported Event|Experimental: Healthy Subjects|Novel Personal Lubricant Miami w/o Fragrance
642687|NCT02320214|B1|Baseline|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
642688|NCT02320214|P1|Participant Flow|Novel Lubricant Miami w/ Frag Personal Lubricant|Healthy subjects use Novel lubricant Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
642689|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
642690|NCT02320214|O1|Outcome|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
642691|NCT02320214|E1|Reported Event|Miami w/ Frag Personal Lubricant|Healthy subjects use Miami w/ frag Personal lubricant at least 4 times per week for 2 weeks.
642692|NCT02319668|B3|Baseline|Total|Total of all reporting groups
642693|NCT02319668|B2|Baseline|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
642694|NCT02319668|B1|Baseline|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
642695|NCT02319668|P2|Participant Flow|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
642696|NCT02319668|P1|Participant Flow|Test and Reference Product|Participants rinsed for one timed minute with 10 milliliter (mL) of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
642697|NCT02319668|O2|Outcome|Reference Product|Participants did not receive any product (mouthwash containing Chlorhexidine digluconate or toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
642698|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product only (mouthwash containing Chlorhexidine digluconate). Participants did not receive reference product(toothpaste containing sodium fluoride) during analysis of this outcome as this analysis was performed at baseline.
642699|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
642700|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
642701|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
642732|NCT02319148|B2|Baseline|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642702|NCT02319668|O1|Outcome|Test and Reference Products|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
642703|NCT02319668|O2|Outcome|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
642704|NCT02319668|O1|Outcome|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brush prior to using mouthwash).
642705|NCT02319668|E2|Reported Event|Reference Product|Participants applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes. They then rinsed their mouth thoroughly with water after brushing.
642706|NCT02319668|E1|Reported Event|Test and Reference Product|Participants rinsed for one timed minute with 10 mL of Test product (Mouthwash containing Chlorhexidine digluconate). Participants also applied a strip of reference product (toothpaste containing sodium fluoride) to cover the head of the toothbrush and brushed in their usual manner for two timed minutes first and thoroughly rinsed their mouth with water and waited for 5 timed minutes before using the mouthwash (except when used on site where they did not brushed prior to using mouthwash).
642707|NCT02319525|B3|Baseline|Total|Total of all reporting groups
642708|NCT02319525|B2|Baseline|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642709|NCT02319525|B1|Baseline|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642710|NCT02319525|P2|Participant Flow|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642711|NCT02319525|P1|Participant Flow|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642712|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642713|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642714|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642715|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642716|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642717|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642718|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642719|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642720|NCT02319525|O2|Outcome|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642721|NCT02319525|O1|Outcome|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642722|NCT02319525|E2|Reported Event|Pamphlet|Participants received the standard American College of Rheumatology lupus pamphlet
642723|NCT02319525|E1|Reported Event|Decision Aid|Participants received decision aid tool providing information about medication choices for lupus nephritis
642724|NCT02319486|B1|Baseline|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
642725|NCT02319486|P1|Participant Flow|CEV With/Without Carboplatin|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
642726|NCT02319486|O2|Outcome|CEV With/Without Carboplatin - Stage 3|CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
642727|NCT02319486|O1|Outcome|CEV With/Without Carboplatin- Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
642728|NCT02319486|E2|Reported Event|CEV With/Without Carboplatin-Stage 3|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
642729|NCT02319486|E1|Reported Event|CEV With/Without Carboplatin-Stage 2|"CEV chemotherapy(CEV Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months) together with/without 20mg/2ml carboplatin periocular injection~carboplatin periocular injection: chemotherapy together with/without 20mg/2ml carboplatin periocular injection~CEV chemotherapy: vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2"
642733|NCT02319148|B1|Baseline|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642734|NCT02319148|P4|Participant Flow|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642735|NCT02319148|P3|Participant Flow|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642736|NCT02319148|P2|Participant Flow|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642737|NCT02319148|P1|Participant Flow|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642738|NCT02319148|O7|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642739|NCT02319148|O6|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642741|NCT02319148|O4|Outcome|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
642745|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642746|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642747|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642748|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642749|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642750|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642751|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642752|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642753|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642754|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642755|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642756|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642757|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642758|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642759|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642760|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642761|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642762|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642763|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642764|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642765|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642766|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642767|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642768|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642769|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642770|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642771|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642772|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642773|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642774|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642775|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642776|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642777|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642778|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642779|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642781|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642782|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642783|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642784|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642785|NCT02319148|O4|Outcome|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642786|NCT02319148|O3|Outcome|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642787|NCT02319148|O2|Outcome|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642788|NCT02319148|O1|Outcome|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642789|NCT02319148|E7|Reported Event|PF-00489791 20 mg + Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days and a single-dose of PF-00489791 20 mg on Day 11 during Period 2.
642790|NCT02319148|E6|Reported Event|PF-00489791 20 mg + Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days and a single-dose of PF-00489791 20mg on Day 11 during Period 2
642791|NCT02319148|E5|Reported Event|PF-00489791 20 mg + Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days and a single-dose of PF-00489791 20 mg on Day 5 during Period 2.
642792|NCT02319148|E4|Reported Event|Verapamil 240 mg|All participants who received verapamil 240 mg SR tablet orally once daily for 13 days.
642793|NCT02319148|E3|Reported Event|Diltiazem 240 mg|All participants who received diltiazem 240 mg MR tablet orally once daily for 13 days.
642794|NCT02319148|E2|Reported Event|Itraconazole 200 mg|All participants who received itraconazole 200 mg orally once daily for 7 days.
642795|NCT02319148|E1|Reported Event|PF-00489791 20 mg|All participants who received a single-dose of PF-00489791 20 mg tablet orally during Period 1.
642796|NCT02319031|B3|Baseline|Total|Total of all reporting groups
642797|NCT02319031|B2|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642798|NCT02319031|B1|Baseline|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642810|NCT02318940|B2|Baseline|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
653865|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
642799|NCT02319031|P2|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642800|NCT02319031|P1|Participant Flow|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642801|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642818|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
642802|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642803|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642804|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642805|NCT02319031|O2|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642806|NCT02319031|O1|Outcome|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642807|NCT02319031|E2|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 16 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 16 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642808|NCT02319031|E1|Reported Event|Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks)|Treatment-naïve and treatment-experienced participants with HCV Genotype 3 infection and advanced fibrosis or compensated cirrhosis (F3 or F4) were treated for 12 weeks with oral dosing of Daclatasvir (DCV) 60mg once daily, Sofosbuvir (SOF) 400mg once daily, and Ribavirin (RBV) 1000-1200mg (weight based dosing) split into am and pm dosing. Participants received either 400 mg (2 tablets for participants < 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) of RBV in the morning with food and 600 mg (3 tablets) of RBV in the evening with food. After the completion of the 12 week treatment period, participants were followed off treatment for 24 weeks. mg=milligram; kg=kilogram
642809|NCT02318940|B3|Baseline|Total|Total of all reporting groups
642811|NCT02318940|B1|Baseline|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
642812|NCT02318940|P2|Participant Flow|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
642813|NCT02318940|P1|Participant Flow|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
642814|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
642815|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
642816|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
642817|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
643266|NCT02313558|E2|Reported Event|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
642819|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
642820|NCT02318940|O2|Outcome|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
642821|NCT02318940|O1|Outcome|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
642822|NCT02318940|E2|Reported Event|Ultrasound Method|"installation of Central venous catheter This arm of the catheter is installed using real-time ultrasound. Access will be through the femoral vein only~central venous catheter: installation of Central venous catheter ultrasound guided"
642823|NCT02318940|E1|Reported Event|Landmark Method|"installation of Central venous catheter In this arm the catheter will be installed under the usual method guided by anatomical landmarks.~access will be through the femoral vein only~central venous catheter: installation of Central venous catheter landmark guided"
642824|NCT02318693|B3|Baseline|Total|Total of all reporting groups
642825|NCT02318693|B2|Baseline|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
642826|NCT02318693|B1|Baseline|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642827|NCT02318693|P2|Participant Flow|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days. TDD = Total daily dose.
642828|NCT02318693|P1|Participant Flow|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642829|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
642830|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642831|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
642832|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642833|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
642834|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642835|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
642836|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642837|NCT02318693|O2|Outcome|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
642838|NCT02318693|O1|Outcome|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642839|NCT02318693|E2|Reported Event|Glibenclamide 2.50 mg TDD|Glibenclamide 1.25 mg administered orally twice daily (2.5 mg TDD) for 14 days.
642840|NCT02318693|E1|Reported Event|Sitagliptin 50 mg|Sitagliptin 50 mg administered orally once daily before breakfast for 14 days.
642841|NCT02317809|B1|Baseline|All Subjects|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector or 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first or second intervention period.
642842|NCT02317809|P2|Participant Flow|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
642899|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
642843|NCT02317809|P1|Participant Flow|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
642844|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642845|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642846|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642847|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642848|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642849|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
648929|NCT02246114|P2|Participant Flow|Arm B|CO monitor
642850|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642851|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642852|NCT02317809|O2|Outcome|First Freeze-dried Pergoveris, Then Liquid Pergoveris|Subjects were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
642853|NCT02317809|O1|Outcome|First Liquid Pergoveris, Then Freeze-dried Pergoveris|Subjects were administered with 900 international units (IU) of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in the first intervention period followed by 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in the second intervention period. Both the periods were separated by a washout period of 14 to 17 days.
642854|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642855|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642856|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642857|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642858|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642859|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642860|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642861|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642862|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642863|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642864|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642900|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642901|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
642865|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642866|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642867|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642868|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642869|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642870|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642871|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642872|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642873|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642874|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642875|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642876|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642877|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642878|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642879|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642880|NCT02317809|O2|Outcome|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642881|NCT02317809|O1|Outcome|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642882|NCT02317809|E2|Reported Event|Freeze-dried Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
642883|NCT02317809|E1|Reported Event|Liquid Pergoveris|All subjects who were administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
642884|NCT02317510|B3|Baseline|Total|Total of all reporting groups
642885|NCT02317510|B2|Baseline|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
642886|NCT02317510|B1|Baseline|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
642887|NCT02317510|P2|Participant Flow|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
642888|NCT02317510|P1|Participant Flow|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642889|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
642890|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642891|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
642892|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642893|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
642894|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642895|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
642896|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642897|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
642898|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
653866|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
642902|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642903|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
642904|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642905|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
642906|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642907|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
642908|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642909|NCT02317510|O2|Outcome|Group 2|Laparoscopic cholecystectomy in combined anesthesia (Spinal epidural).
642910|NCT02317510|O1|Outcome|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642911|NCT02317510|O2|Outcome|Group 2|"Laparoscopic cholecystectomy in combined anesthesia (Spino epidural).~general anesthesia: General anesthesia for laparoscopic cholecystectomy"
642912|NCT02317510|O1|Outcome|Group 1|"Laparoscopic cholecystectomy in General Anesthesia~combined anesthesia: Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy"
642913|NCT02317510|E2|Reported Event|Group 2|Laparoscopic cholecystectomy in combined spinal epidural anaesthesia
642914|NCT02317510|E1|Reported Event|Group 1|Laparoscopic cholecystectomy in General Anesthesia
642915|NCT02317016|B1|Baseline|AZD9291 and Rosuvastatin|Sequential treatments of rosuvastatin alone administered as a single dose (Period 1), followed by AZD9291 alone administered once daily (Period 2), followed by rosuvastatin single dose + AZD9291 once daily dosing (Period 3) (Part A).
642916|NCT02317016|P1|Participant Flow|AZD9291 and Rosuvastatin|Sequential treatments of rosuvastatin alone administered as a single dose (Period 1), followed by AZD9291 alone administered once daily (Period 2), followed by rosuvastatin single dose + AZD9291 once daily dosing (Period 3) (Part A).
642917|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642918|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642919|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642920|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642921|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642922|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642923|NCT02317016|O1|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642924|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642946|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
642925|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
642926|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642927|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
642928|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642929|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
643267|NCT02313558|E1|Reported Event|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
642930|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642931|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
642932|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642933|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
642934|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642935|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
642936|NCT02317016|O2|Outcome|AZD9291 + Rosuvastatin (Period 3 [Day 32])|Steady state AZD9291 80 mg in combination with rosuvastatin 20 mg single oral dose on Day 32 (Part A). The Day 32 treatment (AZD9291 plus rosuvastatin) could occur within a window of ±2 days. Treatment was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose. Previously, patients had received AZD9291 80 mg once daily for 28 days during Period 2 (Days 4 to 31), and after Day 32 in Period 3 (Days 33 and 34) patients also received AZD9291 80 mg once daily doses.
642937|NCT02317016|O1|Outcome|Rosuvastatin Alone (Period 1 [Day 1])|Rosuvastatin 20 mg single oral dose on Day 1 (Part A). Rosuvastatin was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after dose.
642938|NCT02317016|E1|Reported Event|AZD9291 and Rosuvastatin|Sequential treatments of rosuvastatin alone administered as a single dose (Period 1), followed by AZD9291 alone administered once daily (Period 2), followed by rosuvastatin single dose + AZD9291 once daily dosing (Period 3) (Part A).
642939|NCT02316769|B3|Baseline|Total|Total of all reporting groups
642940|NCT02316769|B2|Baseline|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
642941|NCT02316769|B1|Baseline|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
642942|NCT02316769|P2|Participant Flow|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
642943|NCT02316769|P1|Participant Flow|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
642944|NCT02316769|O2|Outcome|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
642945|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
643967|NCT02310646|O4|Outcome|Prefer Foam - Not at All Important Factor|Subjects who prefer foam
642947|NCT02316769|O1|Outcome|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
642948|NCT02316769|E2|Reported Event|McGrath MAC Video Laryngoscope|"Patient intubated with the McGrath MAC Video Laryngoscope~Intubation with the McGrath MAC video laryngoscope"
642949|NCT02316769|E1|Reported Event|King Vision Video Laryngoscope|"Patient intubated with the King Vision Video Laryngoscope~Intubation with the King Vision video laryngoscope"
642950|NCT02316678|B3|Baseline|Total|Total of all reporting groups
642951|NCT02316678|B2|Baseline|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
642952|NCT02316678|B1|Baseline|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
642953|NCT02316678|P2|Participant Flow|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
642954|NCT02316678|P1|Participant Flow|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
642955|NCT02316678|O2|Outcome|Steroids|Prolonged users of steroids defined as either >3000 mg of prednisone (or equivalent) or >600 mg of budesonide divided between ≥2 prescriptions within 12 months and absence of any anti-TNF therapy during the same 12 months.
642956|NCT02316678|O1|Outcome|Anti-TNF|New users of anti-TNF therapy defined as ≥ 1 dispensing for an anti-TNF drug with ≥1 filled CS prescription and no dispensing for any anti-TNF medication in the 12 months preceding the first anti-TNF dispensing.
642957|NCT02316678|E2|Reported Event|Corticosteroids - no Intervention|"Patients initiating corticosteroids~No intervention: There is no intervention"
642958|NCT02316678|E1|Reported Event|Anti-TNF - no Intervention|"Patients who are new users of anti-TNF therapy~No intervention: There is no intervention"
642959|NCT02316613|B1|Baseline|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642960|NCT02316613|P1|Participant Flow|All Participants|Participants with histologically confirmed, refractory/relapsed cluster of differentiation-20 (CD20) positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642961|NCT02316613|O2|Outcome|Maintenance Therapy|During maintenance therapy the participants received or did not received treatment with the MabThera.
642962|NCT02316613|O1|Outcome|First Induction|During the induction period participants received either MabThera monotherapy, MabThera combination therapy (chemotherapy and at least one cycle with MabThera), or all cycles performed without MabThera administration.
642963|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642964|NCT02316613|O1|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
642965|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
642966|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
642967|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
642968|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
642969|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
642970|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
642971|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received treatment with MabThera after the first study induction period was reported.
642972|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received treatment with MabThera over the first study induction period was reported.
642973|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
642974|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
642975|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
642976|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
642977|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642978|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642979|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642980|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642981|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642982|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642983|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642984|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period. Participants who received MabThera maintenance therapy after the first study induction was reported.
642985|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years. Participants who received MabThera treatment over the first study induction period was reported.
642986|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642987|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642988|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642989|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
642990|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
642991|NCT02316613|O2|Outcome|MabThera as Maintenance Therapy|Treatment with MabThera was defined as the administration of at least one cycle of MabThera during maintenance therapy or observation period.
642992|NCT02316613|O1|Outcome|Without MabThera|Treatment without MabThera was defined as the absence of MabThera administration during maintenance therapy or observation period.
642993|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin's lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment.
642994|NCT02316613|O1|Outcome|All Participants|Participants with histologically confirmed, refractory/relapsed CD2 0-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642995|NCT02316613|E1|Reported Event|All Participants|Participants with histologically confirmed, refractory/relapsed CD20-positive follicular non-Hodgkin’s lymphoma (grade IIII), whatever the first-line treatment was (chemotherapy and/or immunotherapy and/or radio-immunoconjugate and/or radiochemotherapy), and eligible for salvage treatment were observed for approximately 6 years.
642996|NCT02316470|B5|Baseline|Total|Total of all reporting groups
642997|NCT02316470|B4|Baseline|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
642998|NCT02316470|B3|Baseline|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
642999|NCT02316470|B2|Baseline|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643000|NCT02316470|B1|Baseline|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643001|NCT02316470|P4|Participant Flow|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28~Placebo: phosphate buffered saline (PBS) solution"
643002|NCT02316470|P3|Participant Flow|VLA84 200 mcg w/ Alum|"VLA84 200 mcg w/ (with) Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643003|NCT02316470|P2|Participant Flow|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643027|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643004|NCT02316470|P1|Participant Flow|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 1 injection of 0.75 mL (milliliters) VLA84 w/o Alum and 1 injection of 0.75 mL Placebo Vaccination Days: 0, 7 and 28~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643005|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643006|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643007|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643008|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643009|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643010|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643011|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643012|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643013|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643014|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643015|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643016|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643017|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643018|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643019|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643020|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643968|NCT02310646|O3|Outcome|Prefer Foam - Not Very Important Factor|Subjects who prefer foam
643021|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643022|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643023|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643024|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643025|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643026|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643028|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643029|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643030|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643031|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643032|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643033|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643034|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643035|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643036|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643037|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643038|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643039|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643040|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643041|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643042|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643043|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643196|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643044|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643045|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643046|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643047|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643048|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643049|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643050|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643051|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643052|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643053|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643054|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643055|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643056|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643057|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643058|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643059|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643060|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643061|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643062|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643063|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643064|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643065|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643066|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643197|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643067|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643068|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643069|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643070|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643071|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643072|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643073|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643074|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643075|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643076|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643077|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643078|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643079|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643080|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643081|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643082|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643083|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643084|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643085|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643086|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643087|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643088|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643089|NCT02316470|O4|Outcome|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643198|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
653867|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
643090|NCT02316470|O3|Outcome|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643091|NCT02316470|O2|Outcome|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643092|NCT02316470|O1|Outcome|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643093|NCT02316470|E4|Reported Event|Placebo|"Placebo consists of 2 injections each with 1.0 mL PBS (Phosphate Buffered Saline) Vaccination Days: 0, 7 and 28 each with two injections~Placebo: phosphate buffered saline (PBS) solution"
643094|NCT02316470|E3|Reported Event|VLA84 200 mcg With Alum|"VLA84 200 mcg with Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 with Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643095|NCT02316470|E2|Reported Event|VLA84 200 mcg w/o Alum|"VLA84 200 mcg w/o Alum consists of 2 injections each with 1.0 mL (milliliters) VLA84 w/o Alum Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B"
643268|NCT02313233|B3|Baseline|Total|Total of all reporting groups
643480|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
643096|NCT02316470|E1|Reported Event|VLA84 75 mcg (Microgram) w/o Alum|"VLA84 75 mcg w/o Alum consists of 0.75 mL (milliliters) VLA84 w/o Alum and 0.75 mL Placebo Vaccination Days: 0, 7 and 28 each with two injections~VLA84: a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B~Placebo: phosphate buffered saline (PBS) solution"
643097|NCT02316366|B3|Baseline|Total|Total of all reporting groups
643098|NCT02316366|B2|Baseline|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
643099|NCT02316366|B1|Baseline|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
643100|NCT02316366|P2|Participant Flow|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
643101|NCT02316366|P1|Participant Flow|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
643102|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
643103|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
643104|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
643105|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
643106|NCT02316366|O2|Outcome|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
643107|NCT02316366|O1|Outcome|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
643108|NCT02316366|E2|Reported Event|Room Temperature Fluid|Patients receive intravenous saline at room temperature (22-24 degrees Celsius)
643109|NCT02316366|E1|Reported Event|Warm Fluid|"Patients in this arm of the study receive intravenous saline warmed to 37.5 degrees Celsius by Astoflo Plus fluid warmer~Astoflo Plus fluid warmer: A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius"
643110|NCT02315989|B1|Baseline|Safety|"proton therapy~proton therapy: proton therapy"
643111|NCT02315989|P1|Participant Flow|Safety|"proton therapy~proton therapy: proton therapy"
643112|NCT02315989|O3|Outcome|Inevaluable|Inevaluable (NE), Inevaluable for response: specify reasons (for example: early death, malignant disease; toxicity; tumor assessments not repeated/incomplete; other (specify).
643113|NCT02315989|O2|Outcome|Partial Response|Partial Response(PR), At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
643114|NCT02315989|O1|Outcome|Stable Disease|Stable Disease(SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
643115|NCT02315989|O1|Outcome|The Frequency of Operation of the System Error|6 subjects received a total of 165 proton therapy, a total of 21 times the system running abnormalities. There was no correlation between system abnormalities during the study and the adverse events.
643116|NCT02315989|O1|Outcome|Safety|"proton therapy~proton therapy: proton therapy"
643117|NCT02315989|E1|Reported Event|Safety|"proton therapy~proton therapy: proton therapy"
643118|NCT02315352|B3|Baseline|Total|Total of all reporting groups
643119|NCT02315352|B2|Baseline|Rac-PZQ Then L-PZQ (Day 1)|Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643129|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
643120|NCT02315352|B1|Baseline|L-PZQ Then Rac-PZQ (Day 1)|L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643121|NCT02315352|P8|Participant Flow|Cesol® Then Rac-PZQ Then L-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643133|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
644220|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
643122|NCT02315352|P7|Participant Flow|Cesol® Then L-PZQ Then Rac-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Cesol® 150 mg as a suspension via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Rac -PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643123|NCT02315352|P6|Participant Flow|Rac-PZQ Then L-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643124|NCT02315352|P5|Participant Flow|Rac-PZQ Then Cesol® Then L-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received Rac-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643125|NCT02315352|P4|Participant Flow|L-PZQ Then Cesol® Then Rac-PZQ (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Cesol® 150 mg administered as a suspension via a syringe in the buccal cavity in fourth intervention period and then Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643126|NCT02315352|P3|Participant Flow|L-PZQ Then Rac-PZQ Then Cesol® (Day 2)|Subjects who were randomized to either ‘L-PZQ Then Rac-PZQ’ or ‘Rac-PZQ Then L-PZQ’ sequence on Day 1 received L-PZQ 150 mg ODT as a solution via a syringe in the buccal cavity in third intervention period followed by Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in fourth intervention period and then Cesol® (currently available praziquantel tablet) 150 mg administered as a suspension via a syringe in the buccal cavity in the fifth intervention period. A washout period of 1 hour was maintained between the intervention periods. The interventions were dispersed in water and administered in the buccal cavity using a syringe. Subject was asked to hold the solution/suspension for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643127|NCT02315352|P2|Participant Flow|Rac-PZQ Then L-PZQ (Day 1)|Subjects were administered Rac-PZQ 150 mg ODT in first intervention period followed by L-PZQ 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643128|NCT02315352|P1|Participant Flow|L-PZQ Then Rac-PZQ (Day 1)|Subjects were administered L- Praziquantel (L-PZQ) 150 milligram (mg) oral disintegrating tablet (ODT) in first intervention period followed by racemate praziquantel (Rac-PZQ) 150 mg ODT in the second intervention period. A washout period of 1 hour was maintained between the intervention periods. The intervention was directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643193|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643194|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643130|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643131|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643132|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643240|NCT02313766|P1|Participant Flow|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
643134|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
643135|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643136|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643137|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643138|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643139|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
643140|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643141|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643142|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643143|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643144|NCT02315352|O5|Outcome|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
643145|NCT02315352|O4|Outcome|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643146|NCT02315352|O3|Outcome|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643147|NCT02315352|O2|Outcome|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643148|NCT02315352|O1|Outcome|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643195|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
643149|NCT02315352|E5|Reported Event|Cesol® (With Water) Day 2|All subjects who received Cesol® administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles.
643150|NCT02315352|E4|Reported Event|Rac-PZQ (With Water) Day 2|All subjects who received Rac-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643151|NCT02315352|E3|Reported Event|L-PZQ (With Water) Day 2|All subjects who received L-PZQ 150 mg ODT administered as a solution via a syringe in the buccal cavity in any intervention period. Subject was asked to hold the solution for 10 sec in mouth and then spat out the liquid in a waste container. A mouth check should be performed after the administration to ensure that no particles remain in the oral cavity.
643220|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643152|NCT02315352|E2|Reported Event|Rac-PZQ (Without Water) Day 1|All subjects who received Rac-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643153|NCT02315352|E1|Reported Event|L-PZQ (Without Water) Day 1|All subjects who received L-PZQ 150 mg ODT directly placed on the tongue of the subjects (without water) and the subjects were asked to spit out the tablet in a waste container in any intervention period. A mouth check was performed after the assessment to ensure that no particles remain in the oral cavity.
643154|NCT02314689|B1|Baseline|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
643155|NCT02314689|P1|Participant Flow|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
643156|NCT02314689|O1|Outcome|IV Citrulline|"IV citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.~Intravenous (IV) citrulline"
643157|NCT02314689|E1|Reported Event|Intravenous (IV) Citrulline|Intravenous (IV) citrulline 20 mg/kg bolus with dose escalation of 10 mg/kg to target citrulline concentration of 100 µmol/L with a maximum dose of 60 mg/kg.
643158|NCT02314637|B3|Baseline|Total|Total of all reporting groups
643159|NCT02314637|B2|Baseline|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
643160|NCT02314637|B1|Baseline|Teneligliptin|Teneligliptin for 52 weeks
643161|NCT02314637|P2|Participant Flow|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea (glimepiride)
643162|NCT02314637|P1|Participant Flow|Teneligliptin|Teneligliptin for 52 weeks
643163|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
643164|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
643165|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
643166|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
643167|NCT02314637|O2|Outcome|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
643168|NCT02314637|O1|Outcome|Teneligliptin|Teneligliptin for 52 weeks
643169|NCT02314637|E2|Reported Event|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
643170|NCT02314637|E1|Reported Event|Teneligliptin|Teneligliptin for 52 weeks
643171|NCT02314546|B4|Baseline|Total|Total of all reporting groups
643172|NCT02314546|B3|Baseline|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643173|NCT02314546|B2|Baseline|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643174|NCT02314546|B1|Baseline|Saline Placebo|Control patients received intranasal saline.
643175|NCT02314546|P3|Participant Flow|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643176|NCT02314546|P2|Participant Flow|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643177|NCT02314546|P1|Participant Flow|Saline Placebo|Control patients received intranasal saline.
643178|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643179|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643180|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
643181|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643182|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643183|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
643184|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643185|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643186|NCT02314546|O1|Outcome|Saline Placebo|Control patients will received intranasal saline.
643187|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643188|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643189|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
643190|NCT02314546|O3|Outcome|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643191|NCT02314546|O2|Outcome|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643192|NCT02314546|O1|Outcome|Saline Placebo|Control patients received intranasal saline.
643199|NCT02314546|E3|Reported Event|Midazolam Plus Xylocaine|Patients received 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
643200|NCT02314546|E2|Reported Event|Nasal Midazolam Only|Patients received 0.2 mg/kg of intranasal midazolam
643201|NCT02314546|E1|Reported Event|Saline Placebo|Control patients received intranasal saline.
643202|NCT02314260|B1|Baseline|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
643262|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
645425|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
643203|NCT02314260|P1|Participant Flow|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
643204|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
643205|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
643206|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
643207|NCT02314260|O1|Outcome|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
643208|NCT02314260|E1|Reported Event|Labour Induction|"80 primigravidas undergoing bishop score calculation, trans-vaginal ultrasound assessment of cervical length &, Modified bishop score calculation, then induction of labour at our hospital.~bishop score calculation: Assessment of bishop score by vaginal examination~Trans-vaginal ultrasound: trans-vaginal ultrasound assessment of cervical length.~Modified bishop score calculation: using the cervical length and the original bishop score to calculate modified bishop score~labour induction: Induction of labor was carried out as per our hospital’s standard protocol."
643209|NCT02314104|B4|Baseline|Total|Total of all reporting groups
643210|NCT02314104|B3|Baseline|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643211|NCT02314104|B2|Baseline|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643212|NCT02314104|B1|Baseline|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643213|NCT02314104|P3|Participant Flow|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643214|NCT02314104|P2|Participant Flow|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643215|NCT02314104|P1|Participant Flow|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643216|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643237|NCT02313766|B1|Baseline|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
643217|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643218|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643219|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643221|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643222|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643223|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643224|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643225|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643226|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643227|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643228|NCT02314104|O3|Outcome|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643229|NCT02314104|O2|Outcome|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643230|NCT02314104|O1|Outcome|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643231|NCT02314104|E3|Reported Event|Treatment TAP, Treatment Local Injection|"Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643232|NCT02314104|E2|Reported Event|Placebo TAP, Treatment Local Injection|"Placebo TAP was 30 mL of 0.9% normal saline bilaterally. Treatment local injection was 2 mL of 0.5% ropivacaine at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643233|NCT02314104|E1|Reported Event|Treatment TAP, Placebo Local Injection|"Treatment TAP block was 30 mL 0.5% ropivacaine bilaterally. Placebo local injection was 2 mL of 0.9% normal saline at each port site.~ropivacaine: Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally."
643234|NCT02313766|B4|Baseline|Total|Total of all reporting groups
643235|NCT02313766|B3|Baseline|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
643236|NCT02313766|B2|Baseline|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
643253|NCT02313558|B3|Baseline|Total|Total of all reporting groups
643969|NCT02310646|O2|Outcome|Prefer Foam - Fairly Important Factor|Subjects who prefer foam
643238|NCT02313766|P3|Participant Flow|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
643239|NCT02313766|P2|Participant Flow|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
643263|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
643241|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
643242|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
643243|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
643244|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
643245|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
643246|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
643247|NCT02313766|O3|Outcome|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
643248|NCT02313766|O2|Outcome|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
643249|NCT02313766|O1|Outcome|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
643250|NCT02313766|E3|Reported Event|PPV + PEEP|"PEEP : PPV + PEEP : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) with PEEP at 6 cmH2O.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=6 cmH2O End of preoxygenation FEO2=90%~PEEP : PPV + PEEP: Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)"
643251|NCT02313766|E2|Reported Event|Positive Pressure Ventilation (PPV)|"PPV : positive pressure ventilation : preoxygenation with noninvasive positive inspiratory pressure ventilation (12 cmH2O) without PEEP.~Preoxygenation through a face mask firmly applied and connected to the anaesthesia machine - non invasive inspiratory ventilation mode - inspiratory trigger sensitivity was set at -2 l min-1, the adjustable pressure limiting valve was opened, and maximal airway pressure was limited at 18 cmH2O - PEEP=0 cmH2O End of preoxygenation FEO2=90%~PPV : positive pressure ventilation: Inspiratory pressure support ventilation (12 cmH2O) without PEEP"
643252|NCT02313766|E1|Reported Event|Spontaneous Breathing (SB)|"preoxygenation through a face mask firmly applied and connected to the anaesthesia machine delivering a fresh gas flow of 12 l min-1. The inspired O2 concentration was set at 100%.~End of preoxygenation FEO2=90%"
643254|NCT02313558|B2|Baseline|Control Dentifrice|"use the control dentifrice to brush teeth twice daily for 12 weeks~Control dentifrice: Use the dentifrice to brush teeth twice a day for 12 weeks"
643255|NCT02313558|B1|Baseline|Dentifrice Containing Ilex Rotunda Thunb|"use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks~Dentifrice Containing Ilex Rotunda Thunb: Use the dentifrice to brush teeth twice a day for 12 weeks"
643256|NCT02313558|P2|Participant Flow|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
643257|NCT02313558|P1|Participant Flow|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
643258|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
643259|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
643260|NCT02313558|O2|Outcome|Control Dentifrice|use the control dentifrice to brush teeth twice daily for 12 weeks
643261|NCT02313558|O1|Outcome|Dentifrice Containing Ilex Rotunda Thunb|use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
645426|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
643269|NCT02313233|B2|Baseline|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643270|NCT02313233|B1|Baseline|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643271|NCT02313233|P2|Participant Flow|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643272|NCT02313233|P1|Participant Flow|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is given as add-on therapy for benigh prostate hyperplasia (BPH). All the subjects have the history for this medical condition and receive the medication. Each subject receives Umooze in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643273|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643274|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of the study product was given 2 tablets with about 240 ml of water."
643275|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643276|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. The study product is given as add- on therapy in BPH. All the eligible subjects included in this study have the history for benign prostate hyperplasia (BPH) and receive the medication for this condition. Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643970|NCT02310646|O1|Outcome|Prefer Foam - Very Important Factor|Subjects who prefer foam
643277|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643278|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643279|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643280|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643281|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
648930|NCT02246114|P1|Participant Flow|Arm A|no CO monitor
643282|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643283|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643284|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643285|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643286|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643287|NCT02313233|O2|Outcome|Placebo|Cornstarch is used as placebo. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643288|NCT02313233|O1|Outcome|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy bean Extracts 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643289|NCT02313233|E2|Reported Event|Placebo|Cornstarch is used as placebo. It's taken for the subjects who are diagnosed as benign prostate hyperplasia (BPH) and given medication only once a day before going to bed. Each subject receives the placebo in the morning and evening for a continuous 56- day. Each oral dose of placebo was given 2 tablets with about 240 ml of water.
643324|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643325|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643326|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643290|NCT02313233|E1|Reported Event|Umooze|"Tablet oral dosage. Astragalus radix Extracts 480 mg+ Soy extract 20 mg~Umooze: Umooze is consisted of Astragalus radix extracts and soy isoflavones. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia. Umooze is used as add- on therapy for the subjects who take the medication for benign prostate hyperplasia (BPH). Each subject receives the study product in the morning and evening for a continuous 56- day. Each oral dose of Umooze was given 2 tablets with about 240 ml of water."
643291|NCT02313155|B3|Baseline|Total|Total of all reporting groups
643292|NCT02313155|B2|Baseline|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643293|NCT02313155|B1|Baseline|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643294|NCT02313155|P2|Participant Flow|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643295|NCT02313155|P1|Participant Flow|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643296|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643297|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643298|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
648931|NCT02246114|O2|Outcome|Arm B|CO monitor
643299|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643300|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643301|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643302|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643303|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643304|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643305|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643306|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643307|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643308|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643309|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643310|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643311|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643312|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643313|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643314|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643315|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643316|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643317|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643318|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643319|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643320|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643321|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643322|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643323|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643327|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643328|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643329|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643330|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643331|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643332|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643333|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643334|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643335|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643336|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643337|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643338|NCT02313155|O2|Outcome|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643339|NCT02313155|O1|Outcome|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643340|NCT02313155|E2|Reported Event|TAK-850 Intramuscular Injection|TAK-850 0.5 mL (15 mcg of HA per strain), injection, intramuscular, once on Day 1 in a treatment period of 22 days.
643341|NCT02313155|E1|Reported Event|TAK-850 Subcutaneous Injection|TAK-850 0.5 mL (15 microgram [mcg] of hemagglutinin [HA] per strain), injection, subcutaneous, once on Day 1 in a treatment period of 22 days.
643342|NCT02312739|B3|Baseline|Total|Total of all reporting groups
643343|NCT02312739|B2|Baseline|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643344|NCT02312739|B1|Baseline|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643345|NCT02312739|P2|Participant Flow|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643346|NCT02312739|P1|Participant Flow|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643347|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643378|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643379|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
643348|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643349|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643350|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643351|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643352|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643353|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643354|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643355|NCT02312739|O2|Outcome|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643356|NCT02312739|O1|Outcome|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643380|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643543|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643357|NCT02312739|E2|Reported Event|Placebo Pills and Nitrous Oxide|"Patients in this group will receive two placebo pills, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Nitrous oxide will be administered during the procedure via scented mask.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Placebo pills: Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure~Nitrous Oxide: Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm"
643358|NCT02312739|E1|Reported Event|Vicodin, Lorazepam and Oxygen|"Patients in this group will receive the Standard Oral Pain Medications consisting of Vicodin and Lorazepam, as well as intramuscular ketorolac at least 30 minutes prior to the procedure. Oxygen via scented mask will also given.~All participants randomized to this group will undergo in-office transcervical sterilization (Essure® procedure ) using standard technique.~Standard Oral pain medications: one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure~Intramuscular Ketorolac: 30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure~Oxygen: Oxygen at 5L/min given to patients randomized to the active comparator arm"
643359|NCT02312726|B1|Baseline|Total Participants Enrolled in Study|Participant characteristics for those enrolled in the study, in both the epidural and non-epidural group
643360|NCT02312726|P3|Participant Flow|Excluded|Participants who did not meet inclusion criteria or declined after consent.
643361|NCT02312726|P2|Participant Flow|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
648932|NCT02246114|O1|Outcome|Arm A|no CO monitor
643362|NCT02312726|P1|Participant Flow|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643363|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643364|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643365|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643366|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643367|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643368|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643369|NCT02312726|O2|Outcome|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643370|NCT02312726|O1|Outcome|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion.~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643371|NCT02312726|E2|Reported Event|Non Epidural Group|"Participants who elect not to have epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643372|NCT02312726|E1|Reported Event|Epidural Group|"Participants who elect to have an epidural anesthesia during labor, delivery and postplacental IUD insertion~Postplacental IUD insertion: Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery."
643373|NCT02312154|B1|Baseline|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643374|NCT02312154|P1|Participant Flow|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643375|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
643376|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643377|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
644251|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
643381|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
643382|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643383|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
643384|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643385|NCT02312154|O2|Outcome|Untreated Side|Eligible patients received injections of NASHA into the dermis on one side of the lower part of the cheek in a single session, at the start of the study (visit 1); the other side was left untreated.
643386|NCT02312154|O1|Outcome|Treated Side (Restylane Vital)|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643387|NCT02312154|E1|Reported Event|Restylane Vital|"stabilized hyaluronic acid (HA)-based gel of nonanimal origin~Restylane Vital: stabilized hyaluronic acid (HA)-based gel of nonanimal origin"
643388|NCT02311972|B3|Baseline|Total|Total of all reporting groups
643407|NCT02311972|E1|Reported Event|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
643389|NCT02311972|B2|Baseline|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life. All temperatures entered into the study database.
643390|NCT02311972|B1|Baseline|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on admission, and at 1, 4, 8 and 24 hours. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures. Nurses will record an axillary temperature upon admission to the NICU, and at 1, 4, 8 and 24 hours of age for each infant in both groups on a data sheet at the bedside. These data will be entered into a RedCap data base created for the study.
643391|NCT02311972|P2|Participant Flow|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643392|NCT02311972|P1|Participant Flow|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
643393|NCT02311972|O1|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|The nurse will insert an InnerSense temperature sensor/feeding tube per normal standards as soon after birth as possible, during delivery room stabilization. Nurses will record an axillary temperature upon admission to the NICU, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643394|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643395|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
644408|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
643396|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643397|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
643408|NCT02311907|B3|Baseline|Total|Total of all reporting groups
643409|NCT02311907|B2|Baseline|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643398|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643399|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
643400|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643401|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
643402|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643403|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
643404|NCT02311972|O2|Outcome|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643405|NCT02311972|O1|Outcome|Control - Standard of Care|Infants in the standard of care group will receive no study interventions other than study recorded axillary temperatures on NICU Admission, 1, 4, 8 and 24 hours of age. Infants will receive standard delivery room stabilization and NICU stabilization. Infants in the control group will receive a feeding tube as standard of care, and the standard issue feeding tube used in the Intensive Care Nursery does not have the capability to record or display esophageal temperatures.
644252|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
643406|NCT02311972|E2|Reported Event|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|Infants will have an InnerSense temperature sensor/feeding tube inserted per normal standards as soon after birth as possible, during delivery room stabilization. Axillary temperature will be recorded upon NICU Admission, at 1, 4, 8 and 24 hours of age. The InnerSense tube will be attached to the infant's bedside monitor to continuously display esophageal temperatures. The tube will stay in place until the infant is 24 hours of age. Central body temperature will be displayed continuously for care-providers in the delivery room, through transport from the birthing center to the NICU and through stabilization. Infants will have a thermistor placed on the abdominal skin with standard skin tape once admitted in the NICU. This thermistor will be attached to a Squirrel SQ2010 (Grant Instruments) temperature monitor/data logger to collect abdominal temperatures every minute for the first 24 hours of life.
643410|NCT02311907|B1|Baseline|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643411|NCT02311907|P2|Participant Flow|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643412|NCT02311907|P1|Participant Flow|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643413|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643414|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643415|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643416|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643417|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643418|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643419|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643420|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643421|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643422|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643423|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643424|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643425|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643426|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643427|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643428|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643429|NCT02311907|O2|Outcome|B (Placebo, Paclitaxel)|Patients receive placebo IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes as in arm A.
643430|NCT02311907|O1|Outcome|A (Glutathione, Carboplatin)|Patients receive glutathione IV over 15 minutes, paclitaxel* IV over 3 hours, and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21-28 days for at least 12 weeks in the absence of disease progression or unacceptable toxicity.
643431|NCT02311907|E2|Reported Event|B (Placebo, Paclitaxel)|Quality-of-Life Assessment: Ancillary studies
643432|NCT02311907|E1|Reported Event|A (Glutathione, Carboplatin)|Quality-of-Life Assessment: Ancillary studies
643433|NCT02311881|B4|Baseline|Total|Total of all reporting groups
644409|NCT02305017|E2|Reported Event|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
643434|NCT02311881|B3|Baseline|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643435|NCT02311881|B2|Baseline|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643436|NCT02311881|B1|Baseline|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643437|NCT02311881|P3|Participant Flow|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643438|NCT02311881|P2|Participant Flow|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643479|NCT02311309|P1|Participant Flow|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
643439|NCT02311881|P1|Participant Flow|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 milligram (mg) sustained release (SR) tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 milliliter [mL]) of water/dose for 12 weeks.
643440|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643441|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643442|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643443|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643444|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643445|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643446|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643447|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643448|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643449|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643450|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643451|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643452|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
644077|NCT02310126|O2|Outcome|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
643453|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
643454|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces (~ 240 mL) of water/dose for 12 weeks.
643455|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643456|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643457|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643458|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643459|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643460|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643461|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643462|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643463|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643464|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643465|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643466|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643467|NCT02311881|O3|Outcome|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643468|NCT02311881|O2|Outcome|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643469|NCT02311881|O1|Outcome|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643470|NCT02311881|E3|Reported Event|Placebo|Participants were instructed to take two placebo to match paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643471|NCT02311881|E2|Reported Event|Paracetamol 1330 mg Thrice Daily (TID)|Participants were instructed to take two active paracetamol 665 mg SR tablets orally thrice daily (with 6-8 hours between adjacent doses) and two placebo to match paracetamol 1000 mg SR tablets orally twice daily (with 10-12 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
644200|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
643472|NCT02311881|E1|Reported Event|Paracetamol 2000 mg Twice Daily (BID)|Participants were instructed to take two active paracetamol 1000 mg SR tablets twice daily (with 10-12 hours between adjacent doses) and two placebo to match paracetamol 665 mg SR tablets thrice daily (with 6-8 hours between adjacent doses) orally with approximately 8 ounces ( ̴240 mL) of water/dose for 12 weeks.
643473|NCT02311309|B4|Baseline|Total|Total of all reporting groups
643474|NCT02311309|B3|Baseline|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
643475|NCT02311309|B2|Baseline|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
643476|NCT02311309|B1|Baseline|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
643477|NCT02311309|P3|Participant Flow|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
643478|NCT02311309|P2|Participant Flow|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
645427|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
643481|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
643482|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
643483|NCT02311309|O3|Outcome|No Significant Bleeding|Patients in whom surgery did not resulted in significant bleeding
643484|NCT02311309|O2|Outcome|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
643485|NCT02311309|O1|Outcome|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
643486|NCT02311309|E3|Reported Event|No Peroperative Significant Bleeding|Patients for whom surgery did not result in significant bleeding
643487|NCT02311309|E2|Reported Event|Unanticipated Bleeding|"Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or hemoglobin concentration < 8 g/dL.~Unanticipated bleeding: Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL."
643488|NCT02311309|E1|Reported Event|Control|"Patients with either transfusion with pre ordered packed red blood cells or hemoglobin concentration > 8 g/dL.~Control: Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL."
643489|NCT02310776|B1|Baseline|Automated & Handheld Beast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
643490|NCT02310776|P1|Participant Flow|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
643491|NCT02310776|O1|Outcome|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
643492|NCT02310776|E1|Reported Event|Automated & Handheld Breast US Exams|"Automated breast ultrasound exam: 3D supine automated breast ultrasound scanner; Supine automated breast ultrasound scanner: Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.~Handheld breast ultrasound exam: High-resolution handheld breast ultrasound; Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist"
643493|NCT02310750|B12|Baseline|Total|Total of all reporting groups
643494|NCT02310750|B11|Baseline|PF-06700841: 100 mg Food Effect Cohort|All participants who received either PF-06700841 100 mg tablet under fasted condition or PF-06700841 100 mg tablet under fed condition or PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in any 1 of the 6 treatment sequences in food effects cohort of the study.
643495|NCT02310750|B10|Baseline|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643496|NCT02310750|B9|Baseline|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643497|NCT02310750|B8|Baseline|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643498|NCT02310750|B7|Baseline|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
643499|NCT02310750|B6|Baseline|PF-­06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
643500|NCT02310750|B5|Baseline|PF­-06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
643501|NCT02310750|B4|Baseline|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
643502|NCT02310750|B3|Baseline|PF­-06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
643503|NCT02310750|B2|Baseline|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643504|NCT02310750|B1|Baseline|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643505|NCT02310750|P16|Participant Flow|PF-06700841: 100 mg Tablet Fed, Tablet Fasted, Solution Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
643506|NCT02310750|P15|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fed, Tablet Fasted|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
643507|NCT02310750|P14|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Solution Fasted, Tablet Fed|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
643508|NCT02310750|P13|Participant Flow|PF-06700841: 100 mg Tablet Fed, Solution Fasted, Tablet Fasted|Participants received PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
643509|NCT02310750|P12|Participant Flow|PF-06700841: 100 mg Solution Fasted, Tablet Fasted, Tablet Fed|Participants received PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 2 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
643510|NCT02310750|P11|Participant Flow|PF-06700841: 100 mg Tablet Fasted, Tablet Fed, Solution Fasted|Participants received PF-06700841 100 mg tablet under fasted condition at Day 1 of treatment period 1 (9 days) followed by washout period (5 days) followed by PF-06700841 100 mg tablet under fed condition at Day 1 of treatment period 2 (9 days) followed by second washout period (5 days) followed by PF-06700841 100 mg oral solution/suspension under fasted condition at Day 1 of treatment period 3 (9 days) in food effect cohorts.
643511|NCT02310750|P10|Participant Flow|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643512|NCT02310750|P9|Participant Flow|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643513|NCT02310750|P8|Participant Flow|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643541|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643542|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643514|NCT02310750|P7|Participant Flow|Placebo: SAD Cohort Then MAD Cohort|Healthy participants received placebo matched to PF-06700841 single tablet orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then placebo matched to PF-06700841 tablet once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days followed by placebo matched to PF-06700841 tablet twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
643515|NCT02310750|P6|Participant Flow|PF-­06700841: 200 mg SAD Cohort, 175 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 175 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
643516|NCT02310750|P5|Participant Flow|PF­-06700841: 100 mg SAD, 100 mg MAD, 50 mg MAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 100 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days) followed by washout period of at least 7 days, then PF-06700841 tablet 50 mg orally, twice daily from Day 1 to Day 10 in the treatment period 3 for MAD cohort (28 days).
643517|NCT02310750|P4|Participant Flow|PF-06700841: 30 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 30 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
643518|NCT02310750|P3|Participant Flow|PF­-06700841: 10 mg SAD Cohort Then MAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1 in the treatment period 1 for SAD cohort (8 days) followed by washout period of at least 7 days, then PF-06700841 tablet 10 mg orally, once daily from Day 1 to Day 10 in the treatment period 2 for MAD cohort (28 days).
648933|NCT02246114|E2|Reported Event|Arm B (CO Monitor)|CO monitor
643519|NCT02310750|P2|Participant Flow|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643520|NCT02310750|P1|Participant Flow|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643521|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643522|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643523|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643524|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643525|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643526|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643527|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643528|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643529|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643530|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643531|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643532|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643533|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643534|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643535|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643536|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643537|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643538|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643539|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643540|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
644201|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
643544|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643545|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643546|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643547|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643548|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643549|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643550|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643551|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643552|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643553|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
645428|NCT02288273|E2|Reported Event|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
643554|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643555|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643556|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643557|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643558|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643559|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643560|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643561|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643562|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643563|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643564|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643565|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643566|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643567|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643568|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643569|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643570|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643571|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643572|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643573|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643574|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643575|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643576|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643577|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643578|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643579|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643580|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643581|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643582|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643583|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643584|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643585|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643586|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643587|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643588|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643589|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643590|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643591|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643592|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643593|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643594|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643595|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643596|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643597|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643598|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643599|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643600|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643601|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643602|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643603|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643604|NCT02310750|O7|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643605|NCT02310750|O6|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643606|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643607|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643608|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
653868|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
643609|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643610|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643611|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643612|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643613|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643614|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643615|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643616|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643617|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
648934|NCT02246114|E1|Reported Event|Arm A (no CO Monitor)|no CO monitor
643618|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643619|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643620|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643621|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643622|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643623|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643624|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643625|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643626|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643627|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643628|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643629|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643630|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643631|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643632|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643633|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643634|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643635|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643636|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643637|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643638|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643639|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643640|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
644410|NCT02305017|E1|Reported Event|Opicapone Alone|Opicapone, OPC, BIA 9-1079 alone
643641|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643642|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643643|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643644|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643645|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643646|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643647|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643648|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643649|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643650|NCT02310750|O16|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643651|NCT02310750|O15|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643652|NCT02310750|O14|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643653|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643654|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643655|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643656|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643657|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643658|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643659|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643660|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643661|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643662|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643663|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643664|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643665|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643666|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643667|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643668|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643669|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643670|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643671|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643672|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643673|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643674|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643675|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643676|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643677|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643678|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643679|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643680|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643681|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643682|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643683|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643684|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643685|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643686|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643687|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643688|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643689|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643690|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643691|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643692|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643693|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643694|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643695|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643696|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643697|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643698|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643699|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643700|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643701|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643702|NCT02310750|O7|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643703|NCT02310750|O6|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643704|NCT02310750|O5|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643705|NCT02310750|O4|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643706|NCT02310750|O3|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
644305|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
643707|NCT02310750|O2|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643708|NCT02310750|O1|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643709|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643710|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643711|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643712|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643713|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643714|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643715|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643809|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643716|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643717|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643718|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643719|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643720|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643721|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643722|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643723|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643724|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643725|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643726|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643727|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643728|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643729|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643730|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643731|NCT02310750|O13|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643732|NCT02310750|O12|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643733|NCT02310750|O11|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643734|NCT02310750|O10|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643735|NCT02310750|O9|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643736|NCT02310750|O8|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643737|NCT02310750|O7|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643738|NCT02310750|O6|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
644411|NCT02304926|B3|Baseline|Total|Total of all reporting groups
653869|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
643739|NCT02310750|O5|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643740|NCT02310750|O4|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643741|NCT02310750|O3|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643742|NCT02310750|O2|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643743|NCT02310750|O1|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643744|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643745|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643746|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
644088|NCT02309723|O3|Outcome|No Beta Amyloid Information|
648935|NCT02246062|B5|Baseline|Total|Total of all reporting groups
643747|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643748|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643749|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643750|NCT02310750|O3|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643751|NCT02310750|O2|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643752|NCT02310750|O1|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643753|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643754|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643755|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643756|NCT02310750|O10|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643757|NCT02310750|O9|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643758|NCT02310750|O8|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643759|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643760|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643761|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643762|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643763|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643764|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643765|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643766|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643767|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643768|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643769|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
644926|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
643770|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643771|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643772|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643773|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643774|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643775|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643776|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
644089|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
643777|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643778|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643779|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643780|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643781|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643782|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643783|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643784|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643785|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643786|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643787|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643788|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643789|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643790|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643791|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643792|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643793|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643794|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643795|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643796|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643797|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643798|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643799|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643800|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643801|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643802|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643803|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643804|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643805|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643806|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643807|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643808|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
649227|NCT02242630|B5|Baseline|Total|Total of all reporting groups
643810|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643811|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643812|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643813|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643814|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643815|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643816|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643817|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643818|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643819|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643820|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643821|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643822|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643823|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643824|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643825|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643826|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643827|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643828|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643829|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643830|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643831|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643832|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643833|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643899|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643834|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643835|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643836|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643837|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643838|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643839|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643840|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
650003|NCT02230956|B4|Baseline|Total|Total of all reporting groups
643841|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643842|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643843|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643844|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643845|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643846|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643847|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643848|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643849|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643850|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643851|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643852|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643853|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643854|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643855|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643856|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643857|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643858|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643859|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643860|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643861|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643862|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643863|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643864|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643865|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643866|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643867|NCT02310750|O20|Outcome|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643868|NCT02310750|O19|Outcome|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643869|NCT02310750|O18|Outcome|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643870|NCT02310750|O17|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643871|NCT02310750|O16|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643872|NCT02310750|O15|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
644090|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
643873|NCT02310750|O14|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643874|NCT02310750|O13|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643875|NCT02310750|O12|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643876|NCT02310750|O11|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643877|NCT02310750|O10|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643878|NCT02310750|O9|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643879|NCT02310750|O8|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643880|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643881|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643882|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643883|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643884|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643885|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643886|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643887|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643888|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643889|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643890|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643891|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643892|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643893|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643894|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643895|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643896|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643897|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643898|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643900|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643901|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643902|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643903|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643904|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643905|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643906|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643907|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643908|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643909|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643910|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643911|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643912|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643913|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643914|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643915|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643916|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643917|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643918|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643919|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643920|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643921|NCT02310750|O3|Outcome|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643922|NCT02310750|O2|Outcome|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643923|NCT02310750|O1|Outcome|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643924|NCT02310750|O7|Outcome|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643925|NCT02310750|O6|Outcome|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643926|NCT02310750|O5|Outcome|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643927|NCT02310750|O4|Outcome|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643928|NCT02310750|O3|Outcome|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643929|NCT02310750|O2|Outcome|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643930|NCT02310750|O1|Outcome|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643931|NCT02310750|O7|Outcome|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643932|NCT02310750|O6|Outcome|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643933|NCT02310750|O5|Outcome|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643934|NCT02310750|O4|Outcome|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643935|NCT02310750|O3|Outcome|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643936|NCT02310750|O2|Outcome|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643937|NCT02310750|O1|Outcome|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643938|NCT02310750|E20|Reported Event|PF-06700841: 100 mg Tablet Fed (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fed condition in either 1 of the 3 treatment period in food effects cohort of the study.
643939|NCT02310750|E19|Reported Event|PF-06700841: 100 mg Solution Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg oral solution/suspension under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643940|NCT02310750|E18|Reported Event|PF-06700841: 100 mg Tab Fasted (Food Effect Cohort)|All participants who received PF-06700841 100 mg tablet under fasted condition in either 1 of the 3 treatment period in food effects cohort of the study.
643941|NCT02310750|E17|Reported Event|PF-06700841: 100 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643942|NCT02310750|E16|Reported Event|PF-06700841: 30 mg MAD Psoriasis Cohort|Participants with Psoriasis received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643943|NCT02310750|E15|Reported Event|PF-06700841: 175 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 175 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643944|NCT02310750|E14|Reported Event|PF-06700841: 200 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 200 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643945|NCT02310750|E13|Reported Event|PF-06700841: 50 mg Twice Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 50 mg orally, twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643946|NCT02310750|E12|Reported Event|PF-06700841: 100 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 100 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643947|NCT02310750|E11|Reported Event|PF-06700841: 100 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 100 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643948|NCT02310750|E10|Reported Event|PF-06700841: 30 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 30 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643949|NCT02310750|E9|Reported Event|PF-06700841: 30 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 30 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643950|NCT02310750|E8|Reported Event|PF-06700841: 10 mg Once Daily MAD Cohort|Healthy participants received PF-06700841 tablet of 10 mg orally, once daily from Day 1 to Day 10. Treatment period 2 for MAD period was of 28 days.
643951|NCT02310750|E7|Reported Event|PF-06700841: 10 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 10 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643952|NCT02310750|E6|Reported Event|PF-­06700841: 3 mg SAD Cohort|Healthy participants received PF-06700841 single tablet of 3 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643953|NCT02310750|E5|Reported Event|PF­-06700841: 1 Milligram (mg) SAD Cohort|Healthy participants received PF-06700841 single tablet of 1 mg, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643954|NCT02310750|E4|Reported Event|Placebo: MAD Psoriasis Cohort|Participants with Psoriasis received placebo matched to PF-06700841 tablet orally, once daily from Day 1 to Day 28. Treatment period 2 for MAD Psoriasis cohort was of 56 days.
643955|NCT02310750|E3|Reported Event|Placebo: Twice Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally twice daily from Day 1 to Day 10. Treatment period 3 for MAD cohort was of 28 days.
643956|NCT02310750|E2|Reported Event|Placebo: Once Daily MAD Cohort|Healthy participants received placebo matched to PF-06700841 tablet orally once daily from Day 1 to Day 10. Treatment period 2 for MAD cohort was of 28 days.
643957|NCT02310750|E1|Reported Event|Placebo: SAD Cohort|Healthy participants received single tablet of placebo matched to PF-06700841, orally on Day 1. Treatment period 1 for SAD cohort was of 8 days.
643958|NCT02310646|B3|Baseline|Total|Total of all reporting groups
643959|NCT02310646|B2|Baseline|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
643960|NCT02310646|B1|Baseline|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
643961|NCT02310646|P2|Participant Flow|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
643962|NCT02310646|P1|Participant Flow|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
643963|NCT02310646|O8|Outcome|Prefer Gel - Not at All Important Factor|Subjects who prefer gel
643964|NCT02310646|O7|Outcome|Prefer Gel - Not Very Important Factor|Subjects who prefer gel
643965|NCT02310646|O6|Outcome|Prefer Gel - Fairly Important Factor|Subjects who prefer gel
643966|NCT02310646|O5|Outcome|Prefer Gel - Very Important Factor|Subjects who prefer gel
643971|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
643972|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
643973|NCT02310646|O2|Outcome|All Subjects Gel|Subject assessments of Daivobet® gel compared to latest topical treatment (CLTT analysis set).
643974|NCT02310646|O1|Outcome|All Subjects Foam|Subject assessments of LEO 90100 aerosol foam compared to latest topical treatment (CLTT analysis set).
643975|NCT02310646|O3|Outcome|Daivobet® Gel|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline.~Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group."
643976|NCT02310646|O2|Outcome|LEO 90100 Aerosol Foam|"Subjects who had used topical treatment to treat their psoriasis within 3 months prior to Baseline.~Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 aerosol foam assessments from the foam-gel group as well as the gel-foam group."
643977|NCT02310646|O1|Outcome|Latest Topical Treatment|Subjects who had used topical treatment to treat their psoriasis within 3 months prior to baseline. Assessments of last topical treatment (TPUQ tool) at baseline.
644091|NCT02309723|O3|Outcome|No Beta Amyloid Information|
643978|NCT02310646|O2|Outcome|Daivobet® Gel|Subject assessments of Daivobet® gel. This column shows Daivobet® gel assessments from the foam-gel group as well as the gel-foam group.
643979|NCT02310646|O1|Outcome|LEO 90100 Areosol Foam|Subject assessments of LEO 90100 aerosol foam. This column shows LEO 90100 foam assessments from the foam-gel group as well as the gel-foam group.
643980|NCT02310646|O3|Outcome|Gel - Foam|Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam
643981|NCT02310646|O2|Outcome|Foam - Gel|Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel
643982|NCT02310646|O1|Outcome|All Randomised Subjects|All randomised subjects (foam – gel and gel – foam)
643983|NCT02310646|E2|Reported Event|Gel - Foam|"Day 1 to 7: Daivobet® gel Day 8 to 14: LEO 90100 aerosol foam~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
643984|NCT02310646|E1|Reported Event|Foam - Gel|"Day 1 to 7: LEO 90100 aerosol foam Day 8 to 14: Daivobet® gel~LEO 90100 Aerosol Foam: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week~Daivobet® gel: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week."
643985|NCT02310568|B6|Baseline|Total|Total of all reporting groups
643986|NCT02310568|B5|Baseline|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
643987|NCT02310568|B4|Baseline|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
643988|NCT02310568|B3|Baseline|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
643989|NCT02310568|B2|Baseline|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 2.
643990|NCT02310568|B1|Baseline|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
643991|NCT02310568|P5|Participant Flow|PF-06372865 7.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
643992|NCT02310568|P4|Participant Flow|PF-06372865 2.5 mg + Placebo|Participants received single oral dose of PF-06372865 2.5 mg tablet twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
643993|NCT02310568|P3|Participant Flow|Placebo + PF-06372865 7.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by single oral dose of PF-06372865 2.5 mg tablet twice daily for one week, then single oral dose of PF-06372865 7.5 mg tablet twice daily for 3 weeks during Stage 2.
643994|NCT02310568|P2|Participant Flow|Placebo + PF-06372865 2.5 mg|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by a single oral dose of PF-06372865 2.5 milligram (mg) tablet twice daily for 4 weeks during Stage 2.
643995|NCT02310568|P1|Participant Flow|Placebo + Placebo|Participants received placebo matched to PF-06372865 twice daily for 4 weeks during Stage 1, followed by placebo matched to PF-06372865 twice daily for 4 weeks during Stage 2.
643996|NCT02310568|O6|Outcome|PF­06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
643997|NCT02310568|O5|Outcome|PF­06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
643998|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
643999|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644000|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644001|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
645027|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
644002|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644003|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644004|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644005|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644006|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644007|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644008|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644009|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
650237|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
644010|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644011|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644012|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644013|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644014|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644015|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644016|NCT02310568|O2|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644017|NCT02310568|O1|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644018|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644019|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644020|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644021|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644022|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644023|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644024|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644025|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644026|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644027|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644028|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644029|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644030|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644031|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644032|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644033|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644034|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644035|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644036|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644037|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644038|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644039|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
653870|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
644040|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644041|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644042|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644043|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644044|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644045|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644046|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644047|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644048|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644049|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644050|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644051|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644052|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644053|NCT02310568|O1|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644054|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644055|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644056|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644057|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644058|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644059|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644060|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644061|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644062|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644063|NCT02310568|O6|Outcome|PF-06372865 7.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 7.5 mg tablet, twice daily for 4 weeks during Stage 2.
644064|NCT02310568|O5|Outcome|PF-06372865 2.5 mg (Stage 2)|All participants who received a single dose of PF-06372865 2.5 mg tablet, twice daily for 4 weeks during Stage 2.
644065|NCT02310568|O4|Outcome|Placebo (Stage 2)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 2.
644066|NCT02310568|O3|Outcome|PF-06372865 7.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 7.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644067|NCT02310568|O2|Outcome|PF-06372865 2.5 mg (Stage 1)|All participants who received a single dose of PF-06372865 2.5 mg tablet, orally twice daily for 4 weeks during Stage 1.
644068|NCT02310568|O1|Outcome|Placebo (Stage 1)|All participants who received placebo matched to PF-06372865 2.5 mg or PF-06372865 7.5 mg, orally twice daily for 4 weeks during Stage 1.
644069|NCT02310568|E3|Reported Event|PF-06372865 7.5 mg|All participants received PF-06372865 7.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
644070|NCT02310568|E2|Reported Event|PF-06372865 2.5 mg|All participants received PF-06372865 2.5 mg twice daily for 4 weeks in Stage 1 and Stage 2.
644071|NCT02310568|E1|Reported Event|Placebo|All participants received placebo matched to PF-06372865 twice daily for 4 weeks in Stage 1 and Stage 2.
644072|NCT02310126|B3|Baseline|Total|Total of all reporting groups
644073|NCT02310126|B2|Baseline|Etafilcon A(Sphere) / Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
644074|NCT02310126|B1|Baseline|Etafilcon A(Sphere) / Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A(multi-focal) contact lens and then received the etafilcon A(sphere) contact lens.
644075|NCT02310126|P2|Participant Flow|Etafilcon A(Sphere)/Etafilcon A(Multi-focal)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A(multi-focal) contact lens.
644076|NCT02310126|P1|Participant Flow|Etafilcon A(Multi-focal)/Etafilcon A(Sphere)|Subjects were randomized to one of two possible lens wear sequences. Subjects first received the etafilcon A (sphere) contact lens and then received the etafilcon A (multi-focal) contact lens.
645192|NCT02291679|P3|Participant Flow|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
644078|NCT02310126|O1|Outcome|Etafilcon A(Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
644079|NCT02310126|E2|Reported Event|Etafilcon A (Sphere)|Subjects that received the etafilcon A (sphere) contact lens during either the first or second period of the study.
644080|NCT02310126|E1|Reported Event|Etafilcon A (Multi-focal)|Subjects that received the etafilcon A (multi-focal) contact lens during either the first or second period of the study.
644081|NCT02309723|B4|Baseline|Total|Total of all reporting groups
644082|NCT02309723|B3|Baseline|No Beta Amyloid Information|Survey respondents presented scenario with no beta amyloid information.
644083|NCT02309723|B2|Baseline|Negative Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a negative finding.
644084|NCT02309723|B1|Baseline|Positive Beta Amyloid Findings|Survey respondents presented scenario in which beta amyloid imaging results indicated a positive finding.
644085|NCT02309723|P3|Participant Flow|No Beta Amyloid Information|
644086|NCT02309723|P2|Participant Flow|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
644087|NCT02309723|P1|Participant Flow|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
644092|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
644093|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
644094|NCT02309723|O3|Outcome|No Beta Amyloid Information|
644095|NCT02309723|O2|Outcome|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
644096|NCT02309723|O1|Outcome|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
644097|NCT02309723|E3|Reported Event|No Beta Amyloid Information|
644098|NCT02309723|E2|Reported Event|Negative Beta Amyloid Findings|"Beta amyloid imaging results indicated a negative finding.~Beta amyloid imaging"
644099|NCT02309723|E1|Reported Event|Positive Beta Amyloid Findings|"Beta amyloid imaging results indicated a positive finding.~Beta amyloid imaging"
644100|NCT02309294|B1|Baseline|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
644101|NCT02309294|P1|Participant Flow|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
644102|NCT02309294|O1|Outcome|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
644103|NCT02309294|E1|Reported Event|Healthy Subject|Occlusive patches applied each day for 14 days for each intervention (Experimental: Novel lubricant Miami w/ fragrance, Experimental: Novel lubricant Miami no fragrance, KY Liquid lubricant, Astroglide Gel lubricant, Wet Platinum lubricant).
644104|NCT02309112|B4|Baseline|Total|Total of all reporting groups
644105|NCT02309112|B3|Baseline|Yoga Group C: Maximum Exposure|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644106|NCT02309112|B2|Baseline|Yoga Group B: Medium Exposure|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644107|NCT02309112|B1|Baseline|Yoga Group A: Minimum Exposure|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644108|NCT02309112|P3|Participant Flow|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644109|NCT02309112|P2|Participant Flow|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644110|NCT02309112|P1|Participant Flow|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644111|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
644218|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
645429|NCT02288273|E1|Reported Event|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
644112|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
644113|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
644114|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
644115|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
644116|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
644117|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|"Maximum Yoga Dose~Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)"
644118|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
644119|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
644120|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
644121|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
644122|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
644123|NCT02309112|O3|Outcome|Yoga Group C: Maximum Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga and; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga; 3 x 60-minute yoga sessions (breathing, meditation and physical postures)
644124|NCT02309112|O2|Outcome|Yoga Group B: Medium Exposure|Week 1: 1 x 75-minute introductory yoga session (breathing, meditation and physical postures); recommended community-based resources for in-person yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat) Weeks 1 to 4: pre-paid online yoga Week 2 or 3: 1 x 120-minute yoga session (breathing, meditation and physical postures)
644125|NCT02309112|O1|Outcome|Yoga Group A: Minimum Exposure|Week 1: 1 x 45-minute introductory yoga session (breathing techniques only); recommended community-based resources for in-person yoga and online yoga; equipment to encourage a home-based practice (i.e illustrated manual, yoga mat)
644126|NCT02309112|O1|Outcome|Eligible Participants|The group of eligible participants who agreed to be randomized to ono of three yoga groups.
644202|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
645193|NCT02291679|P2|Participant Flow|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
644127|NCT02309112|E3|Reported Event|Yoga Group C|"The maximum-dose yoga package, this intervention includes the components of Group A, with the same 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. As in Group B, a pre-paid online yoga membership to http://www.myyogaonline.com was also provided for the duration of the study. Participants were then invited to attend three 60-minute yoga group classes led by an expert yoga instructor per week (weeks 1 to 4). These yoga sessions were held in a clinical setting in proximity to their treatment location and delivered at no cost to the patient.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644128|NCT02309112|E2|Reported Event|Yoga Group B|"The medium-exposure yoga package, this intervention includes the components of Group A, with an additional 30-minute orientation and safety training of how to practice yoga dhyana (meditation techniques) and asana (physical postures) in week one. Participants were invited to stay and ask questions following the yoga class. A pre-paid online yoga membership to http://www.myyogaonline.com was offered for the duration of the study. In addition to this, one 120-minute workshop to further develop yoga pranayama, dhyana and asana training was administered by an expert instructor during week 2 or 3.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644219|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
645430|NCT02287779|B9|Baseline|Total|Total of all reporting groups
644129|NCT02309112|E1|Reported Event|Yoga Group A|"The minimum-exposure yoga package, this intervention included 45-minutes of contact time with a trained yoga professional. This session included a 30-minute introductory session focussing on pranayama (breathing techniques), as well as a brief introduction to available community-based and online yoga to encourage a safe home-based practice (15-minutes). Financial subsidy, compensation or special promotion of any particular yoga was not provided. Participants were invited to stay for a social discussion following the yoga class.~Yoga: A mind-body therapy that includes specified breathing, meditation and physical postures."
644130|NCT02308787|B1|Baseline|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644131|NCT02308787|P1|Participant Flow|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644132|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644133|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644134|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644135|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644136|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644137|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644138|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644139|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644140|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644141|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644142|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644143|NCT02308787|O1|Outcome|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644144|NCT02308787|E1|Reported Event|Subjects Who Received a Minimum of 1 PLTD Procedure u|Eligible subjects had received a minimum of 1 PLTD procedure using the Spectra Optia Apheresis System and had available pre- and post-procedure PLT counts.
644145|NCT02308748|B1|Baseline|All Study Participants|Participants who were randomized to receive either dofetilide alone, dofetilide + mexiletine, dofetilide + lidocaine, moxifloxacin + diltiazem or placebo.
644146|NCT02308748|P10|Participant Flow|C-B-D-E-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment A (dofetilide)"
644147|NCT02308748|P9|Participant Flow|B-E-C-A-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem)"
644148|NCT02308748|P8|Participant Flow|A-E-D-B-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine)"
644149|NCT02308748|P7|Participant Flow|E-B-A-C-D|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem)"
644150|NCT02308748|P6|Participant Flow|D-A-C-E-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment B (dofetilide + lidocaine)"
644151|NCT02308748|P5|Participant Flow|E-A-B-D-C|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment E (placebo) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine)"
644152|NCT02308748|P4|Participant Flow|D-C-A-B-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D (moxifloxacin + diltiazem) Treatment C (dofetilide + mexiletine) Treatment A (dofetilide) Treatment B (dofetilide + lidocaine) Treatment E (placebo)"
644153|NCT02308748|P3|Participant Flow|C-D-B-A-E|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C (dofetilide + mexiletine) Treatment D (moxifloxacin + diltiazem) Treatment B (dofetilide + lidocaine) Treatment A (dofetilide) Treatment E (placebo)"
644154|NCT02308748|P2|Participant Flow|B-C-E-D-A|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B (dofetilide + lidocaine) Treatment C (dofetilide + mexiletine) Treatment E (placebo) Treatment D (moxifloxacin + diltiazem) Treatment A (dofetilide)"
644155|NCT02308748|P1|Participant Flow|A-D-E-C-B|"All subjects received the same 5 treatments, separated by 6 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A (dofetilide) Treatment D (moxifloxacin + diltiazem) Treatment E (placebo) Treatment C (dofetilide + mexiletine) Treatment B (dofetilide + lidocaine)"
644156|NCT02308748|O2|Outcome|Moxifloxacin + Diltiazem|Subjects that completed placebo and moxifloxacin + diltiazem interventions
644157|NCT02308748|O1|Outcome|Moxifloxacin Alone|Subjects that completed placebo and moxifloxacin alone interventions
644158|NCT02308748|O3|Outcome|Dofetilide + Lidocaine|Subjects that completed placebo and dofetilide + lidocaine interventions
644159|NCT02308748|O2|Outcome|Dofetilide + Mexiletine|Subjects that completed placebo and dofetilide + mexiletine interventions
644160|NCT02308748|O1|Outcome|Dofetilide Alone|Subjects that completed placebo and dofetilide alone interventions
644161|NCT02308748|E5|Reported Event|Placebo|"Placebo (#2 gelcap and intravenous saline)~Placebo: Placebo (#2 Gelcap or IV saline)"
644162|NCT02308748|E4|Reported Event|Moxifloxacin + Diltiazem|"Moxifloxacin with and without diltiazem.~Moxifloxacin: • 9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)~2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)~Diltiazem: • 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes"
644163|NCT02308748|E3|Reported Event|Dofetilide + Mexiletine|"Dofetilide combined with mexiletine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Mexiletine: • 8 am: weight x 4 mg/kg~12 pm (noon): Same as at 8 am~5:30 pm: Same as at 8 am"
644164|NCT02308748|E2|Reported Event|Dofetilide + Lidocaine|"Dofetilide combined with lidocaine~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg~Lidocaine: • 9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes~2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes~7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes"
644165|NCT02308748|E1|Reported Event|Dofetilide|"Dofetilide alone arm~Dofetilide: • 8 am: Placebo~12 pm (noon): 250 µg~5:30 pm: 250 µg"
644166|NCT02308371|B3|Baseline|Total|Total of all reporting groups
644167|NCT02308371|B2|Baseline|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
644168|NCT02308371|B1|Baseline|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
644169|NCT02308371|P2|Participant Flow|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
644203|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
644204|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
644205|NCT02308124|E3|Reported Event|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
644206|NCT02308124|E2|Reported Event|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
644207|NCT02308124|E1|Reported Event|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
644170|NCT02308371|P1|Participant Flow|Prospective|"Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5ml/kg increments for PPV> 13.~Automated Pulse Pressure Variation: Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours."
644171|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
644172|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
648646|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
644173|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
644174|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
644175|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
644176|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
644177|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data. PPV was not used to guide therapy in this group of patients.
644178|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output) in addition to information provided by automated pulse pressure variation (PPV). PPV will be followed for first 48 hours after recruitment to the study. Fluid (normal saline, albumin 5%, hetastarch per the clinician preference) will be given in 5cc/kg increments for PPV> 13 (in addition to standard clinical data) until PPV < 13.
644179|NCT02308371|O2|Outcome|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
644180|NCT02308371|O1|Outcome|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
644181|NCT02308371|E2|Reported Event|Retrospective|Patients in this arm were previously admitted to the PICU and were given fluid based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam). PPV was not used to guide therapy in this group of patients.
644182|NCT02308371|E1|Reported Event|Prospective|Patients in this arm will have fluid given based on standard clinical data (blood pressure, heart rate, lactate level, urine output, clinical exam) in addition to information provided by automated pulse pressure variation (PPV).
644183|NCT02308124|B4|Baseline|Total|Total of all reporting groups
644184|NCT02308124|B3|Baseline|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
644185|NCT02308124|B2|Baseline|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
644186|NCT02308124|B1|Baseline|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
644187|NCT02308124|P3|Participant Flow|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
644188|NCT02308124|P2|Participant Flow|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
644189|NCT02308124|P1|Participant Flow|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
644190|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
644191|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
644192|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
644193|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
644194|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
644195|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
644196|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
644197|NCT02308124|O2|Outcome|Pyridostigmine Only|Start Pyridostigmine 30mg bid, and then dose up to 60mg bid after one month if necessary.
644198|NCT02308124|O1|Outcome|Midodrine Only|Start midodrine 2.5mg bid, and then dose up to 5mg bid after one month if necessary.
644199|NCT02308124|O3|Outcome|Midodrine + Pyridostigmine|Start midodrine 2.5mg bid+ Pyridostigmine 30mg bid, and then dose up to midodrine 5mg bid+ Pyridostigmine 60mg bid after one month if necessary.
644209|NCT02307838|B3|Baseline|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
644210|NCT02307838|B2|Baseline|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644211|NCT02307838|B1|Baseline|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644212|NCT02307838|P3|Participant Flow|Placebo|In FTY720D2201, participants received matching placebo to FTY720 q.d. for 6 months.
644213|NCT02307838|P2|Participant Flow|FTY720 1.25 mg|In FTY720D2201, participants received FTY720 1.25 mg q.d. oral dose for 6 months.
644214|NCT02307838|P1|Participant Flow|FTY720 5.0 mg|In FTY720D2201, participants received FTY720 5.0 mg every day (q.d.) oral dose for 6 months.
644215|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644216|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644217|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644221|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644222|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644223|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644224|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644225|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644226|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644227|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644228|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644229|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644230|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644231|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644232|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644233|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644234|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644235|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644236|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644237|NCT02307838|O2|Outcome|Non-continuous|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years.
644238|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644239|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
644240|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
644241|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644242|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
644243|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
644244|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644245|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
644246|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
644247|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644248|NCT02307838|O3|Outcome|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
644249|NCT02307838|O2|Outcome|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high efficacy disease modifying therapies (DMTs) for at least 2 years.
644250|NCT02307838|O1|Outcome|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644253|NCT02307838|E3|Reported Event|Non-continuous: Other DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy DMTs for less than 2 years. This group may have included participants who did not report any DMTs at all.
644254|NCT02307838|E2|Reported Event|Non-continuous: High Efficacy DMTs|Participants had exposure to FTY720 (study drug or commercially) for less than 8 years. Also, participants were exposed to high-efficacy disease modifying therapies (DMTs) for at least 2 years.
644255|NCT02307838|E1|Reported Event|Continuous|Participants had exposure to FTY720 (study drug or commercially) for at least 8 years.
644256|NCT02307318|B1|Baseline|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
644257|NCT02307318|P1|Participant Flow|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
644258|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
644259|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
644260|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
644261|NCT02307318|O1|Outcome|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
644262|NCT02307318|E1|Reported Event|SoftSeal Hemostatic Pad|This is a single-arm study. All patients enrolled received the Softseal hemostatic pad for compression of the access site following elective or urgent coronary angiogram.
644263|NCT02307266|B4|Baseline|Total|Total of all reporting groups
644264|NCT02307266|B3|Baseline|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
644265|NCT02307266|B2|Baseline|Standard of Care|Subjects received standard-of-care instructions only.
644266|NCT02307266|B1|Baseline|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
644267|NCT02307266|P3|Participant Flow|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
644268|NCT02307266|P2|Participant Flow|Standard of Care|Subjects received standard-of-care instructions only.
644269|NCT02307266|P1|Participant Flow|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
644270|NCT02307266|O3|Outcome|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
644271|NCT02307266|O2|Outcome|Standard of Care|Subjects received standard-of-care instructions only.
644272|NCT02307266|O1|Outcome|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
644273|NCT02307266|E3|Reported Event|Standard of Care + Additional Visits|Subjects received standard-of-care instructions, and two additional clinical visits.
644274|NCT02307266|E2|Reported Event|Standard of Care|Subjects received standard-of-care instructions only.
644275|NCT02307266|E1|Reported Event|Standard of Care + Supplementary Education|Subjects received supplementary patient educational material in addition to standard-of-care instructions.
644276|NCT02307188|B1|Baseline|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter."
644277|NCT02307188|P1|Participant Flow|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Since enrollment began, a total of five (5) patients consented to enrollment in the study during their atrial fibrillation/tachycardia ablation procedures. The catheter (a new catheter was used for each patient) was used in the left atrium in one patient who met all inclusion criteria and did not have any exclusions."
644278|NCT02307188|O1|Outcome|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~Five (5) patients were enrolled. The catheters were used in the left atrium in one (1) patient. The remaining patients were excluded because of subtherapeutic ACT levels < 300 seconds (3 patients) or presence of prosthetic valve (1 patient).~Due to the paucity of information collected from the one patient for whom the catheter was used in the left atrium, the collected electrogram data were not analyzed further."
644279|NCT02307188|E1|Reported Event|Basket Catheter|"The Constellation Full Contact Mapping Catheter (multipolar catheter) to be utilized for collection of atrial electrograms.~Constellation Full Contact Mapping Catheter: 64-electrode intracardiac mapping catheter.~No adverse events related to this catheter were noted."
644280|NCT02307123|B1|Baseline|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
644281|NCT02307123|P1|Participant Flow|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
644282|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
644283|NCT02307123|O1|Outcome|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
644284|NCT02307123|E1|Reported Event|HEMS Treated Patients|"Patients whose airways were secured by the HEMS physician.~Intubation: HEMS physician prehospital intubation"
644306|NCT02306759|O2|Outcome|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
645194|NCT02291679|P1|Participant Flow|Placebo|Matching placebo, once daily for 12 weeks
644285|NCT02306928|B1|Baseline|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
644286|NCT02306928|P1|Participant Flow|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
644317|NCT02305329|B3|Baseline|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
644318|NCT02305329|B2|Baseline|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
644319|NCT02305329|B1|Baseline|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
644287|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
644288|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
644289|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
644290|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
644291|NCT02306928|O1|Outcome|Piperacillin Pharmacokinetics|"Patients with known or suspected septic shock who who required noradrenaline infusion and who were prescribed piperaillin/tazobactam 4g/0.5g (Tazocin®) by the treating physician were eligible for the study. Patients on renal replacement therapy and patients under the age of 18 were not included.~Included patients had plasma concentrations of piperacillin, being the active β-lactam component, determined. Age, gender, body weight, APACHE (Acute Physiology and Chronic Health Evaluation) score on admission, SOFA (Sequential Organ Failure Assessment) score on day of sampling, amount of noradrenalin-infusion given during the third dosing interval and presence of acute kidney failure (AKI) of each enrolled patient were registered."
644292|NCT02306928|E1|Reported Event|Piperacillin Pharmacokinetics|Serious and non-serious adverse advents were not collected.
644293|NCT02306759|B3|Baseline|Total|Total of all reporting groups
644294|NCT02306759|B2|Baseline|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
644295|NCT02306759|B1|Baseline|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
644296|NCT02306759|P2|Participant Flow|Placebo|"Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Placebo: Normal saline 50ml, administered over 15 minutes"
644297|NCT02306759|P1|Participant Flow|Treatment|"Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
644298|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644299|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644300|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644301|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644302|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644303|NCT02306759|O1|Outcome|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644304|NCT02306759|O2|Outcome|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644307|NCT02306759|O1|Outcome|Treatment|"Ketamine 0.3mg/kg intravenous piggyback (IVPB) in 50ml NS over 15 minutes~Morphine 0.1mg/kg intravenous push (IVP) PRN at designated intervals~Ketamine: Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes"
644308|NCT02306759|E2|Reported Event|Placebo|Normal saline 50ml IVPB over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644309|NCT02306759|E1|Reported Event|Treatment|Ketamine 0.3mg/kg IVPB in 50ml NS over 15 minutes Morphine 0.1mg/kg IVP PRN at designated intervals
644310|NCT02305446|B1|Baseline|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
644311|NCT02305446|P1|Participant Flow|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
644312|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
644313|NCT02305446|O1|Outcome|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
644314|NCT02305446|E1|Reported Event|rMenB+OMV NZ|Subjects who received two doses of rMenB+OMV NZ according to a 0, 2-month schedule
644315|NCT02305329|B5|Baseline|Total|Total of all reporting groups
644316|NCT02305329|B4|Baseline|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
644320|NCT02305329|P4|Participant Flow|Group 2 BIA 9-1067 50 mg|"Period 1 - 1x50 mg OPC Period 2 - 2x25 mg OPC~BIA 9-1067"
644321|NCT02305329|P3|Participant Flow|Group 1 BIA 9-1067 50 mg|"Period 1 - 2x25 mg OPC Period 2 - 1x50 mg OPC~BIA 9-1067"
644322|NCT02305329|P2|Participant Flow|Group 2 BIA 9-1067 25 mg|"Period 1 - 1x25 mg OPC Period 2 - 5x5 mg OPC~BIA 9-1067"
644323|NCT02305329|P1|Participant Flow|Group 1 BIA 9-1067 25 mg|"Period 1 - 5x5 mg OPC Period 2 - 1x25 mg OPC~BIA 9-1067"
644324|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
644325|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
644326|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
644327|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
644328|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
644329|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
644330|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
644331|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
644332|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
644333|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
644334|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
644335|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
644336|NCT02305329|O4|Outcome|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
644337|NCT02305329|O3|Outcome|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
644338|NCT02305329|O2|Outcome|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
644339|NCT02305329|O1|Outcome|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
644340|NCT02305329|E4|Reported Event|1x50 mg BIA 9-1067|1x50 mg BIA 9-1067, OPC
644341|NCT02305329|E3|Reported Event|2x25 mg BIA 9-1067|2x25 mg BIA 9-1067, OPC
644342|NCT02305329|E2|Reported Event|1x25 mg BIA 9-1067|1x25 mg BIA 9-1067, OPC
644343|NCT02305329|E1|Reported Event|5x5mg BIA 9-1067|5x5mg BIA 9-1067, OPC
644344|NCT02305316|B3|Baseline|Total|Total of all reporting groups
644345|NCT02305316|B2|Baseline|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
644346|NCT02305316|B1|Baseline|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
644347|NCT02305316|P2|Participant Flow|BIA 9-1067 Micronized - Non-micronized|"Each subject was orally administered 50 mg OPC micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC non-micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
644348|NCT02305316|P1|Participant Flow|BIA 9-1067 Non-micronized - Micronized|"Each subject was orally administered with 50 mg OPC non-micronized followed by a washout period of 14 days. After washout period each subject was orally administered with 50 mg OPC micronized~BIA 9-1067 non-micronized~BIA 9-1067 micronized"
644349|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
644350|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
644351|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
644352|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
644353|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
644354|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
644355|NCT02305316|O2|Outcome|BIA 9-1067 Micronized|BIA 9-1067 micronized.
644356|NCT02305316|O1|Outcome|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
644357|NCT02305316|E2|Reported Event|BIA 9-1067 Micronized|BIA 9-1067 micronized.
644358|NCT02305316|E1|Reported Event|BIA 9-1067 Non-micronized|BIA 9-1067 non-micronized.
644359|NCT02305277|B7|Baseline|Total|Total of all reporting groups
644360|NCT02305277|B6|Baseline|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644361|NCT02305277|B5|Baseline|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644407|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol acetominophen
644362|NCT02305277|B4|Baseline|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644363|NCT02305277|B3|Baseline|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644364|NCT02305277|B2|Baseline|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644365|NCT02305277|B1|Baseline|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644366|NCT02305277|P6|Participant Flow|BIA 9-1067 50 mg Sequence 2|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644367|NCT02305277|P5|Participant Flow|BIA 9-1067 25 mg Sequence 2|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644473|NCT02303704|P1|Participant Flow|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644368|NCT02305277|P4|Participant Flow|BIA 9-1067 5 mg Sequence 2|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: TBM Formulation Period 2: CM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644369|NCT02305277|P3|Participant Flow|BIA 9-1067 50 mg Sequence 1|"volunteers received a single oral dose of 50 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644370|NCT02305277|P2|Participant Flow|BIA 9-1067 25 mg Sequence 1|"volunteers received a single oral dose of 25 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644371|NCT02305277|P1|Participant Flow|BIA 9-1067 5 mg Sequence 1|"volunteers received a single oral dose of 5 mg BIA 9-1067: Period 1: CM Formulation Period 2: TBM Formulation~CM - clinical micronized TBM - to-be-marketed~BIA 9-1067 (clinical micronized, CM)~BIA 9-1067 (to-be-marketed, TBM)"
644372|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
644373|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
644374|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
644375|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
644376|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
644377|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
644378|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
644379|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
644380|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
644381|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
644382|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
644383|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
644384|NCT02305277|O6|Outcome|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
644385|NCT02305277|O5|Outcome|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
644386|NCT02305277|O4|Outcome|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
644387|NCT02305277|O3|Outcome|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
644388|NCT02305277|O2|Outcome|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
644389|NCT02305277|O1|Outcome|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
644390|NCT02305277|E6|Reported Event|BIA 9-1067 50 mg TBM|BIA 9-1067 50 mg TBM TBM - to-be-marketed
644391|NCT02305277|E5|Reported Event|BIA 9-1067 50 mg CM|BIA 9-1067 50 mg CM CM - clinical micronized
644392|NCT02305277|E4|Reported Event|BIA 9-1067 25 mg TBM|BIA 9-1067 25 mg TBM TBM - to-be-marketed
644393|NCT02305277|E3|Reported Event|BIA 9-1067 25 mg CM|BIA 9-1067 25 mg CM CM - clinical micronized
644394|NCT02305277|E2|Reported Event|BIA 9-1067 5 mg TBM|BIA 9-1067 5 mg TBM TBM - to-be-marketed
644395|NCT02305277|E1|Reported Event|BIA 9-1067 5 mg CM|BIA 9-1067 5 mg CM CM - clinical micronized
644396|NCT02305017|B3|Baseline|Total|Total of all reporting groups
644397|NCT02305017|B2|Baseline|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
644398|NCT02305017|B1|Baseline|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
644399|NCT02305017|P2|Participant Flow|Period 1 OPC; Period 2 OPC+ Paracetamol|"Period 1 BIA 9-1067 (Opicapone, OPC) Period 2 BIA 9-1067 (Opicapone, OPC) + Paracetamol;~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
644400|NCT02305017|P1|Participant Flow|Period 1 OPC + Paracetamol; Period 2 OPC|"Period 1 BIA 9-1067 (Opicapone, OPC) + Paracetamol; Period 2 BIA 9-1067 (Opicapone, OPC)~BIA 9-1067: BIA 9-1067 50 mg~Paracetamol: Paracetamol 1g"
644401|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
644402|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
644403|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1067 50 mg Paracetamol, acetominophen, 1 g
644404|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1067 50 mg
644405|NCT02305017|O2|Outcome|Opicapone Plus Paracetamol|Opicapone, OPC, BIA 9-1079 Paracetamol, acetominphen
644406|NCT02305017|O1|Outcome|Opicapone Alone|Opicapone, OPC, BIA 9-1079
653871|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
644412|NCT02304926|B2|Baseline|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644413|NCT02304926|B1|Baseline|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644414|NCT02304926|P2|Participant Flow|Ezetimibe|"20 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644934|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644415|NCT02304926|P1|Participant Flow|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644416|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644417|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644418|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644419|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644420|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644421|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644422|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644423|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644424|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644425|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644928|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644426|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644427|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644428|NCT02304926|O2|Outcome|Ezetimibe|"19 hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644429|NCT02304926|O1|Outcome|Simvastatin|"20 hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644430|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644431|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644432|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644433|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644434|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644435|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644436|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644437|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644438|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644439|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
645195|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
644440|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644441|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644442|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644443|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644444|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644445|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644446|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644447|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644448|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644449|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644450|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644451|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644452|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644453|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
645196|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
653872|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
644454|NCT02304926|O2|Outcome|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644455|NCT02304926|O1|Outcome|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644456|NCT02304926|E2|Reported Event|Ezetimibe|"Hyperlipidemic patients received ezetimibe (10 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Ezetimibe: ezetimibe (10 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644457|NCT02304926|E1|Reported Event|Simvastatin|"Hyperlipidemic patients received simvastatin (40 mg/day) for 4 weeks, after they were administered combined therapy (simvastatin, 40 mg/day plus ezetimibe,10 mg/day) for an additional 4-week period. Lipid profile, lipoprotein subfractions of LDL and HDL, inflammatory, oxidative stress and endothelial function parameters were evaluated.~Simvastatin: simvastatin (40 mg/day) for 4 weeks~Simvastatin + Ezetimibe: combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period"
644458|NCT02303743|B3|Baseline|Total|Total of all reporting groups
644459|NCT02303743|B2|Baseline|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
644460|NCT02303743|B1|Baseline|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
644461|NCT02303743|P2|Participant Flow|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
644462|NCT02303743|P1|Participant Flow|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
644463|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
644464|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
644465|NCT02303743|O2|Outcome|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
644466|NCT02303743|O1|Outcome|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
644467|NCT02303743|E2|Reported Event|Control Group|"Written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution~Written instructions with visual aids: written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group)."
644503|NCT02302365|E1|Reported Event|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644504|NCT02301975|B4|Baseline|Total|Total of all reporting groups
644662|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644468|NCT02303743|E1|Reported Event|Smart Phone Application (SPA) Group|"Patients assigned to SPA group were instructed on how to free-download the application onto their smartphone. Each patient enters the date and time of his colonoscopy and timed alerts appeared on the phone to alert the patient of the next step in bowel preparation. In addition to the alerts, the app assists in bowel preparation by explaining the procedure, providing tips, examples of low fiber diet, and displaying pictures of preparation quality and educational video to explain how to prepare the purgative solution.Finally, the patient can obtain a checklist to confirm all steps.~Smart Phone Application: Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure"
644469|NCT02303704|B3|Baseline|Total|Total of all reporting groups
644470|NCT02303704|B2|Baseline|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644471|NCT02303704|B1|Baseline|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts
644472|NCT02303704|P2|Participant Flow|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
648647|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
644474|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644475|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644476|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644477|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644478|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644479|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644480|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644481|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644482|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644483|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644484|NCT02303704|O2|Outcome|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644485|NCT02303704|O1|Outcome|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644486|NCT02303704|E2|Reported Event|Aortic Root Antegrade Cardioplegia|Patients who underwent routine conventional CABG with antegrade aortic root cardioplegia without warm blood perfusion
644487|NCT02303704|E1|Reported Event|Multiport Antegrade Cardioplegia|Patients who received multiport antegrade cardioplegia and continuous controlled warm blood perfusion through vein grafts.
644488|NCT02302365|B1|Baseline|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644489|NCT02302365|P1|Participant Flow|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644490|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644491|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644492|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644493|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644494|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644495|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644496|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644497|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644498|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644499|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644500|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644501|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
644502|NCT02302365|O1|Outcome|Subjects Who Received a Minimum of 1 WBCD Procedure u|Eligible subjects had received a minimum of 1 WBCD procedure using the Spectra Optia Apheresis System
645197|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
644505|NCT02301975|B3|Baseline|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644506|NCT02301975|B2|Baseline|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644507|NCT02301975|B1|Baseline|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644508|NCT02301975|P3|Participant Flow|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644509|NCT02301975|P2|Participant Flow|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644936|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644510|NCT02301975|P1|Participant Flow|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644511|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644512|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644513|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644514|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644515|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644516|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644517|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644518|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644519|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644520|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644521|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644522|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644523|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644524|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644525|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644526|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644527|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644528|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
645198|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
644529|NCT02301975|O3|Outcome|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644530|NCT02301975|O2|Outcome|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644531|NCT02301975|O1|Outcome|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644532|NCT02301975|E3|Reported Event|FP 250 mcg Twice Daily|Participants received FP 250 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644533|NCT02301975|E2|Reported Event|FP/S 250/50 mcg Twice Daily|Participants received FP/S 250/50 mcg via ACCUHALER/DISKUS inhaler twice daily along with placebo via ELLIPTA inhaler once daily (at evening) for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644534|NCT02301975|E1|Reported Event|FF/VI 100/25 mcg Once Daily|Participants received FF/VI 100/25 mcg via ELLIPTA® inhaler once daily (at evening) along with placebo via ACCUHALER/DISKUS® twice daily for 24 weeks. Albuterol/Salbutamol inhalation aerosol was also provided to treat acute asthma symptoms.
644535|NCT02301936|B3|Baseline|Total|Total of all reporting groups
644536|NCT02301936|B2|Baseline|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
644537|NCT02301936|B1|Baseline|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
644538|NCT02301936|P2|Participant Flow|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644539|NCT02301936|P1|Participant Flow|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) 90/400 mg fixed dose combination (FDC) tablet once daily for 12 weeks
644540|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644541|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644542|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644543|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644544|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644545|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644546|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644547|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644548|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644549|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644550|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644551|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644552|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644553|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644554|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644555|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644556|NCT02301936|O2|Outcome|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644557|NCT02301936|O1|Outcome|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644558|NCT02301936|E2|Reported Event|LDV/SOF 24 Weeks|Treatment-experienced participants with cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks.
644559|NCT02301936|E1|Reported Event|LDV/SOF 12 Weeks|Treatment-naive or treatment-experienced participants without cirrhosis received LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks.
644560|NCT02301429|B1|Baseline|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
644561|NCT02301429|P1|Participant Flow|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
644562|NCT02301429|O1|Outcome|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
644563|NCT02301429|E1|Reported Event|Model 20105|"Receiving the model 20105 Lead~Model 20105: implant and follow-up of study device"
644564|NCT02301377|B3|Baseline|Total|Total of all reporting groups
644604|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
653873|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
644565|NCT02301377|B2|Baseline|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
644566|NCT02301377|B1|Baseline|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
644580|NCT02301169|P2|Participant Flow|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644567|NCT02301377|P2|Participant Flow|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
644568|NCT02301377|P1|Participant Flow|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
644569|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
644570|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
644571|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
644572|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
644573|NCT02301377|O2|Outcome|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
644574|NCT02301377|O1|Outcome|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
644575|NCT02301377|E2|Reported Event|Control|Subjects in this group had their adherence to inhaled hypertonic saline, dornase alfa and CF multivitamins during the 3-month study duration monitored through the use of prescription refill histories. They filled out a quality of life questionnaire at enrollment and 3 months. Their height, weight, lung function and frequency of hospitalizations over the previous 3 months was obtained at enrollment and 3-months from review of their medical records.
644631|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
653874|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
644576|NCT02301377|E1|Reported Event|Intervention Group|Subjects in this group were asked to use the Spiro PD personal spirometer to check their lung function once a week for 3 months. They were also asked to use the medication reminder feature of their device daily. Participants were trained on the appropriate use of their device at the time of enrollment. They also received weekly telephone calls from a respiratory therapist to review that week's lung function results. They filled out a quality of life questionnaire at enrollment and at 3 months. Information regarding their height, weight, lung function and frequency of hospitalizations over the previous 3 months were obtained at enrollment and 3-months from review of their medical records. Pharmacies were contacted for refill data during the 3-month study duration for inhaled hypertonic saline, dornase alfa and CF multivitamins.
644577|NCT02301169|B3|Baseline|Total|Total of all reporting groups
644578|NCT02301169|B2|Baseline|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644579|NCT02301169|B1|Baseline|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644581|NCT02301169|P1|Participant Flow|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644582|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644583|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644584|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644585|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644586|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644587|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644588|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644589|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644590|NCT02301169|O2|Outcome|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644591|NCT02301169|O1|Outcome|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644592|NCT02301169|E2|Reported Event|Placebo|"Heat pain stimuli B~Video B~Administration of placebo capsules: This treatment is given as add on therapy to patients' regular analgesic"
644593|NCT02301169|E1|Reported Event|T4P1001|"Heat pain stimuli A~Video A~Administration of T4P1001 capsules: This treatment is given as add on therapy to patients' regular analgesic"
644594|NCT02300311|B3|Baseline|Total|Total of all reporting groups
644595|NCT02300311|B2|Baseline|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
644596|NCT02300311|B1|Baseline|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
644597|NCT02300311|P2|Participant Flow|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
644598|NCT02300311|P1|Participant Flow|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
644599|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
644600|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
644601|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
644602|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
644603|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
645199|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
644605|NCT02300311|O2|Outcome|Finalgon® Cream (Nicoboxil/ Nonivamide)|"Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period.~Treatment duration consists of up to 4 days."
644606|NCT02300311|O1|Outcome|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
644607|NCT02300311|E2|Reported Event|Finalgon® Cream (Nicoboxil/ Nonivamide)|Topical administration of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide). One application consists of 2 cm cream line (3.5 mg Nicoboxil/ 0.5 mg Nonivamide) for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
644608|NCT02300311|E1|Reported Event|Placebo|Topical administration of Placebo cream. One application consists of 2 cm cream line for a skin area of approximately 20 x 20 square cm (corresponding to approximately 2 x hand size) up to 3 times in a 24 h period. Treatment duration consists of up to 4 days.
644992|NCT02294604|B4|Baseline|Total|Total of all reporting groups
644609|NCT02300129|B1|Baseline|All Study Participants (Intent To Treat Population)|One subject was excluded from Intent to Treat (ITT) population because he didn't perform any efficacy assessment during the study so N=33 instead of 34 subjects
644610|NCT02300129|P4|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
644611|NCT02300129|P3|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks then 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks."
644612|NCT02300129|P2|Participant Flow|Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo|"Period 1:~Application of 1g of Placebo Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of CD07805/47 0.5% Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
644613|NCT02300129|P1|Participant Flow|CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo|"Period 1:~Application of 1g of CD07805/47 0.5% Gel on full face on Day 1 (cross-over design) and 500mg on a half-face (split-face design) on Day 3.~Application of 500mg of Placebo Gel on a half-face (split-face design) on Day 3 and 1g on full face on Day 5 (cross-over design).~Period 2 (cross-over design):~Application of 1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks then 1g of Placebo Gel on full face once daily 7 days per week for 2 weeks."
644614|NCT02300129|O2|Outcome|Period 2 Placebo Gel Cross-over|CD07805/47 placebo gel
644615|NCT02300129|O1|Outcome|Period 2 CD07805/47 0.5% Gel Cross-over|CD07805/47 0.5% gel (Brimonidine tartrate)
644616|NCT02300129|E6|Reported Event|Period 2 Placebo Gel Cross Over|Period 2 Placebo gel cross over (application on full face) Overall safety population, N=31
644617|NCT02300129|E5|Reported Event|Period 2 CD07805/47 0.5% Gel Cross Over|Period 2 CD07805/47 0.5% gel (application on full face) Overall safety population, N=32
644618|NCT02300129|E4|Reported Event|Period 1 CD07805/47 0.5% Gel Cross-over|Period 1 CD07805/47 0.5% cross over (application on full face) Overall safety population, N=33
644619|NCT02300129|E3|Reported Event|Period 1 Placebo Gel Split Face|Period 1 Placebo gel split face (application on one side of face) Overall safety population, N=33
644620|NCT02300129|E2|Reported Event|Period 1 CD07805/47 0.5% Gel Split Face|Period 1 CD07805/47 0.5% gel split face (application on one side of face) Overall safety population, N=33
644621|NCT02300129|E1|Reported Event|Period 1 Placebo Gel Cross Over|Period 1 Placebo gel cross over (application on full face) Overall safety population, N=34
644622|NCT02300025|B5|Baseline|Total|Total of all reporting groups
644623|NCT02300025|B4|Baseline|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class c, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644624|NCT02300025|B3|Baseline|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644625|NCT02300025|B2|Baseline|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644626|NCT02300025|B1|Baseline|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644627|NCT02300025|P4|Participant Flow|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644628|NCT02300025|P3|Participant Flow|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644629|NCT02300025|P2|Participant Flow|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644630|NCT02300025|P1|Participant Flow|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 milligrams (mg) cobimetinib (two 5 mg capsules) on Day 1 of study.
645200|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
644632|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644633|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644634|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644635|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644636|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644637|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644638|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644639|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644640|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644641|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644642|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644643|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644644|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644645|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644646|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644647|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644648|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644649|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644650|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644651|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644652|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644653|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644654|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644655|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644656|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644657|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644658|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644659|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644660|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644661|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
645201|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
644663|NCT02300025|O4|Outcome|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class C, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644664|NCT02300025|O3|Outcome|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644665|NCT02300025|O2|Outcome|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644666|NCT02300025|O1|Outcome|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644667|NCT02300025|E4|Reported Event|Cohort 4: Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh Class A, score of 10 to 15, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644668|NCT02300025|E3|Reported Event|Cohort 3: Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh Class B, score of 7 to 9, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644669|NCT02300025|E2|Reported Event|Cohort 2: Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh Class A, score of 5 to 6, inclusive) received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644670|NCT02300025|E1|Reported Event|Cohort 1: Normal Hepatic Function|Participants with normal hepatic function received single oral dose of 10 mg cobimetinib (two 5 mg capsules) on Day 1 of study.
644671|NCT02299869|B5|Baseline|Total|Total of all reporting groups
644672|NCT02299869|B4|Baseline|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644673|NCT02299869|B3|Baseline|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644674|NCT02299869|B2|Baseline|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644675|NCT02299869|B1|Baseline|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644676|NCT02299869|P4|Participant Flow|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644677|NCT02299869|P3|Participant Flow|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644678|NCT02299869|P2|Participant Flow|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644679|NCT02299869|P1|Participant Flow|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644680|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644681|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644682|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644683|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644684|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644685|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644686|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644687|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644688|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644689|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644690|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644691|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644692|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644693|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644694|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644695|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644696|NCT02299869|O4|Outcome|Group 4 - Azul (Competitor-control) vs. Blue (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644697|NCT02299869|O3|Outcome|Group 3 - Esmeralda (Competitor-control) vs. Jade (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644698|NCT02299869|O2|Outcome|Group 2 - Cinza (Competitor-control) vs. Grey (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644699|NCT02299869|O1|Outcome|Group 1 - Verde (Competitor-control) vs. Green (CVI-test)|Each subject was randomized to wear the test and control lenses contralaterally.
644700|NCT02299869|E1|Reported Event|Overall Participants|Each subject was randomized to wear the test and control lenses in a series of four short fitting comparisons (pair 1, pair 2, pair 3, and pair 4).
653875|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
644701|NCT02299635|B1|Baseline|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644702|NCT02299635|P1|Participant Flow|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644703|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644704|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644935|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644705|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644706|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644707|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644708|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644709|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644710|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644711|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644712|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644713|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644714|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644715|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644716|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644717|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644718|NCT02299635|O1|Outcome|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644719|NCT02299635|E1|Reported Event|PF-03084014|PF-03084014 at the starting dose of 150 mg twice daily (BID) (in the form of one 100-mg and one 50-mg tablet) was administered orally BID continuously in 21-day cycles until disease progression, patient refusal of further treatment, or unacceptable toxicity, whichever occurred first.
644720|NCT02299427|B3|Baseline|Total|Total of all reporting groups
644721|NCT02299427|B2|Baseline|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
644722|NCT02299427|B1|Baseline|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
644723|NCT02299427|P2|Participant Flow|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
644724|NCT02299427|P1|Participant Flow|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
644725|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
644726|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
644727|NCT02299427|O2|Outcome|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
644728|NCT02299427|O1|Outcome|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks"
644729|NCT02299427|E2|Reported Event|Transportation Safety|"2 weeks of regular use of publicly-available website on child transportation safety~transportation safety: use of transportation safety website at home for about 2 weeks"
644751|NCT02299258|E2|Reported Event|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
644730|NCT02299427|E1|Reported Event|Dog Safety|"2 weeks of regular use of website on child dog safety developed for this research~dog safety: use of dog safety website at home for about 2 weeks~There is a discrepancy in participants at risk compared to the participant flow module because some children were not compliant to the intervention. They did not use the internet website and therefore were excluded from analyses. They did not have adverse events; they merely were not exposed to the intervention and therefore were excluded from analysis."
644731|NCT02299349|B3|Baseline|Total|Total of all reporting groups
644732|NCT02299349|B2|Baseline|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
644733|NCT02299349|B1|Baseline|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
644734|NCT02299349|P2|Participant Flow|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
644735|NCT02299349|P1|Participant Flow|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
644736|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
644737|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
644738|NCT02299349|O2|Outcome|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
644739|NCT02299349|O1|Outcome|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
644740|NCT02299349|E2|Reported Event|Concentrated Multi Drug Injection|"concentrated multi drug periarticular injection~concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL: Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl"
644741|NCT02299349|E1|Reported Event|Bupivacaine Liposome Suspension|"bupivacaine liposome suspension periarticular injection~bupivacaine liposome suspension: bupivacaine liposome suspension periarticular injection"
644742|NCT02299258|B3|Baseline|Total|Total of all reporting groups
644743|NCT02299258|B2|Baseline|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
644744|NCT02299258|B1|Baseline|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
644745|NCT02299258|P2|Participant Flow|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
644746|NCT02299258|P1|Participant Flow|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
644747|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
644748|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
644749|NCT02299258|O2|Outcome|Standard Stents MTN-CG-s-20/100|"Standard uncovered stents were used in the control group. The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm~Standard stents MTN-CG-s-20/100: The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm"
645202|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
644750|NCT02299258|O1|Outcome|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
644782|NCT02298361|E2|Reported Event|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
644783|NCT02298361|E1|Reported Event|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
644752|NCT02299258|E1|Reported Event|Tailored Stents MTN-WE-20/100-A|"The distal portion of the GOO tailored stents was semi-spherical, with a length of 20 mm, and a diameter of 28 mm. The middle segment had a diameter of 20 mm. The overall length of the stents was 100 mm. Both the middle part and the bottom of the proximal cup segment, and a part of the proximal funnel segment, were covered by a polyethylene membrane.~Tailored stents MTN-WE-20/100-A: cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs."
644753|NCT02298868|B1|Baseline|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644754|NCT02298868|P1|Participant Flow|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644755|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644756|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644757|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644758|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644759|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644760|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644761|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644762|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644763|NCT02298868|O1|Outcome|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644764|NCT02298868|E1|Reported Event|Treatment|All patients will be administered a standing dose of Baclofen initially at 5 mg three times a day for the first week and then increased to 10 mg three times a day for the next 3 weeks with a tapering dose the final week, a total of 5 weeks of therapy.
644765|NCT02298361|B4|Baseline|Total|Total of all reporting groups
644766|NCT02298361|B3|Baseline|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
644767|NCT02298361|B2|Baseline|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
644768|NCT02298361|B1|Baseline|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
644769|NCT02298361|P3|Participant Flow|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
644770|NCT02298361|P2|Participant Flow|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
644771|NCT02298361|P1|Participant Flow|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
644772|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
644773|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
644774|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
644775|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
644776|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
644777|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
645203|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
644778|NCT02298361|O3|Outcome|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
644779|NCT02298361|O2|Outcome|Within-clinic Comparison Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were not used
644780|NCT02298361|O1|Outcome|Intervention Patients|Community Health Centers that implemented health insurance outreach IT tools: active patients on whom tools were used
644781|NCT02298361|E3|Reported Event|Control Clinic Comparison Patients|Matched Community Health Centers that did not implement health insurance outreach IT tools: active patients
644784|NCT02298192|B3|Baseline|Total|Total of all reporting groups
644785|NCT02298192|B2|Baseline|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
644786|NCT02298192|B1|Baseline|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
644787|NCT02298192|P2|Participant Flow|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
644788|NCT02298192|P1|Participant Flow|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
644789|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
644790|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
644791|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
644809|NCT02296931|B2|Baseline|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
644810|NCT02296931|B1|Baseline|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
644927|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644792|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
644813|NCT02296931|O2|Outcome|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
644993|NCT02294604|B3|Baseline|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
644793|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
644794|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
644795|NCT02298192|O2|Outcome|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
644796|NCT02298192|O1|Outcome|IDegLira (1WT)|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira once weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on titration day.
644797|NCT02298192|E2|Reported Event|IDegLira|Subjects inadequately controlled on metformin either alone or in combination with pioglitazone were randomized in a 1:1 manner to receive IDegLira once daily. The subjects were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36mg liraglutide), and the maximum dose was 50 dose steps (50units/1.8mg liraglutide) The daily dose for metformin was ≥ 1500mg or max tolerated dose and ≥ 30mg for pioglitazone. In the IDegLira twice weekly titration group (1WT), the dose of IDegLira was adjusted based on the mean of 3 fasting SMPG values measured pre-breakfast in the morning of three consecutive days corresponding to one obtained on each of two days before titration and one obtained on titration day.
644798|NCT02298192|E1|Reported Event|IDegLira (1WT)|Subjects received IDegLira once weekly in combination with metformin alone or in combination with pioglitazone in a 1:1 manner at visit 2 and were stratified by their OAD treatment prior to entering the trial. The starting dose of IDegLira was 10 dose steps (10 units IDeg/0.36 mg liraglutide), and the maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide).The daily dose for metformin (≥1500 mg or max tolerated dose) and pioglitazone (≥30 mg) The dose of IDegLira was to be adjusted once weekly based on the mean of 2 fasting SMPG values measured pre-breakfast in the morning of two consecutive days corresponding to one obtained on the day before titration and one obtained on the titration day. The first dose of trial product was to be administered either on the day of randomisation (visit 2) or the day after.
644799|NCT02297841|B1|Baseline|HRIPT|Novel lubricant Miami w/ fragrance Novel lubricant Miami w/o fragrance 510(k) cleared and currently marketed personal lubricant 510(k) cleared and currently marketed personal lubricant
644800|NCT02297841|P1|Participant Flow|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
644801|NCT02297841|O1|Outcome|Human Repeat Insult Patch Test|"Experimental: Human Repeat Insult Patch Test~Approximately 0.2ml of each intervention (Experimental: Novel lubricant Miami Fragrance, Experimental: Novel lubricant Miami no Fragrance, KY Liquid lubricant, Astroglide Gel lubricant) was applied to an occlusive patch and applied to participant's back."
644802|NCT02297841|E1|Reported Event|HRIPT|Experimental: Novel lubricant Miami w/ frag Experimental: Novel Miami w/o frag KY Liquid lubricant Astroglide Gel lubricant
644803|NCT02297308|B1|Baseline|SoloPath Sheath|The study focuses on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascualar access
644804|NCT02297308|P1|Participant Flow|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
644805|NCT02297308|O1|Outcome|SoloPath Sheath|Rate of VARC-2 defined access site bleeding complications.
644806|NCT02297308|O1|Outcome|SoloPath Sheath|Vascular Complications
644807|NCT02297308|E1|Reported Event|SoloPath Sheath|The study focused on subjects that underwent TAVI with a SoloPath Sheath used for femoral vascular access.
644808|NCT02296931|B3|Baseline|Total|Total of all reporting groups
644811|NCT02296931|P2|Participant Flow|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
644812|NCT02296931|P1|Participant Flow|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
644932|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644814|NCT02296931|O1|Outcome|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
644815|NCT02296931|E2|Reported Event|Pre-eclamptic Pregnant Women|"In Phase 2, the device will deliver MgSO4 to up to 40 women presenting with symptoms of pre-eclampsia.~Magnesium Sulfate: The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)"
644816|NCT02296931|E1|Reported Event|Healthy Adults|"Phase 1 will be an initial validation of the clinical performance of the device delivering only standard IV saline to 10 stable women.~Saline: Standard IV Saline Fluids"
644817|NCT02295774|B1|Baseline|Group A|"Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~No study drug was taken prior to initial Colonoscopy (White light only)~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
644818|NCT02295774|P1|Participant Flow|Group A|"Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to initial colonoscopy the subjects take Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
644819|NCT02295774|O1|Outcome|Group A|"This is a crossover study. Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks. Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets.~Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
644820|NCT02295774|E1|Reported Event|Group A|"This is a crossover study.~Biopsy samples collected during standard white light colonoscopy.~standard white light colonoscopy-equivalent to placebo: standard white light colonoscopy~No study drug was taken prior to initial Colonoscopy (White light only)~Subjects who have had samples collected during initial colonoscopy, who require a second colonoscopy within 2 weeks.~Prior to this second colonoscopy the subjects take Methylene Blue MMX tablets. Biopsies collected are compared to their initial colonoscopy for histone gamma H2AX activity.~Methylene Blue MMX tablets: 8x25mg methylene blue MMX tablets administered before a colonoscopy"
644821|NCT02295644|B5|Baseline|Total|Total of all reporting groups
644822|NCT02295644|B4|Baseline|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644823|NCT02295644|B3|Baseline|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644824|NCT02295644|B2|Baseline|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644825|NCT02295644|B1|Baseline|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644826|NCT02295644|P4|Participant Flow|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644827|NCT02295644|P3|Participant Flow|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644828|NCT02295644|P2|Participant Flow|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644829|NCT02295644|P1|Participant Flow|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644830|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644831|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644832|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644833|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644834|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644835|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644876|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
644836|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644837|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644838|NCT02295644|O4|Outcome|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644839|NCT02295644|O3|Outcome|C (0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644840|NCT02295644|O2|Outcome|B (0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644841|NCT02295644|O1|Outcome|A (0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644842|NCT02295644|E4|Reported Event|D (0.8W/Square Centimeter, 100%)|"0.8 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644843|NCT02295644|E3|Reported Event|C(0.8W/Square Centimeter, 50%)|"0.8 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644844|NCT02295644|E2|Reported Event|B(0.4W/Square Centimeter, 100%)|"0.4 Watts/Sq cm 100% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644845|NCT02295644|E1|Reported Event|A(0.4W/Square Centimeter, 50%)|"0.4 Watts/Sq cm 50% Duty cycle~Ultrasound Sonicator 740: Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes"
644846|NCT02295020|B3|Baseline|Total|Total of all reporting groups
644847|NCT02295020|B2|Baseline|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
644848|NCT02295020|B1|Baseline|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644849|NCT02295020|P2|Participant Flow|Standard Treatment Plus Bioskin Ten-7.|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
644850|NCT02295020|P1|Participant Flow|Standard Treatment Only.|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
644851|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
644852|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
644853|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
644854|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
644855|NCT02295020|O2|Outcome|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
644856|NCT02295020|O1|Outcome|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
644857|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
644858|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644859|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
644860|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644861|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
644862|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644863|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus knee Bioskin Ten-7 knee brace
644864|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644865|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
644866|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections.
644867|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
644868|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644869|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace
644870|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644871|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
644872|NCT02295020|O1|Outcome|Standard Treatment Only|Standard treatment only such as NSAIDs and injections
644873|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
644874|NCT02295020|O1|Outcome|Standard Treatment Only.|Standard treatment only such as NSAIDs and injections.
644875|NCT02295020|O2|Outcome|Standard Treatment Plus Bioskin Ten-7 Knee Brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
644877|NCT02295020|E2|Reported Event|Group B|"Group B will receive standard treatment and the Bioskin Ten-7 knee brace.~Standard treatment: Standard treatment such as NSAIDs and injections~Standard treatment plus Bioskin Ten-7 knee brace: Standard treatment such as NSAIDs and injections plus knee brace"
644878|NCT02295020|E1|Reported Event|Group A|"Group A will receive standard treatment only~Standard treatment: Standard treatment such as NSAIDs and injections"
644879|NCT02294773|B3|Baseline|Total|Total of all reporting groups
644933|NCT02294734|O2|Outcome|GSK2269557 1000 µg|Participants received 1000 µg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
645215|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
644880|NCT02294773|B2|Baseline|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644881|NCT02294773|B1|Baseline|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644882|NCT02294773|P2|Participant Flow|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644883|NCT02294773|P1|Participant Flow|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644884|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644885|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644886|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644887|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644888|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644889|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644890|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644891|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644924|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644925|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
653876|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
644892|NCT02294773|O2|Outcome|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644893|NCT02294773|O1|Outcome|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644894|NCT02294773|E2|Reported Event|Insemination Day After Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day after the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644895|NCT02294773|E1|Reported Event|Insemination Day Of Positive OPK|"This group takes either clomiphene or letrozole on cycle days 3-7 and then receives intrauterine insemination on the day the home ovulation predictor kit first turns positive.~Intrauterine Insemination: Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.~Clomiphene: Patient is to take clomiphene citrate during cycle days 3-7.~Letrozole: Patient is to take letrozole during cycle days 3-7."
644896|NCT02294734|B3|Baseline|Total|Total of all reporting groups
644897|NCT02294734|B2|Baseline|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644898|NCT02294734|B1|Baseline|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644899|NCT02294734|P2|Participant Flow|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644900|NCT02294734|P1|Participant Flow|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644901|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644902|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644903|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644904|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644905|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644906|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644907|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644908|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644909|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644910|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644911|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644912|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644913|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644914|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644915|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644916|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644917|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644918|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644919|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644920|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644921|NCT02294734|O1|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644922|NCT02294734|O1|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644923|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
645204|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
644929|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644930|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644931|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644937|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644938|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644939|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644940|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644941|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644942|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644943|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644944|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644945|NCT02294734|O2|Outcome|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644946|NCT02294734|O1|Outcome|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644947|NCT02294734|E2|Reported Event|GSK2269557 1000 mcg|Participants received 1000 mcg of GSK2269557 two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644948|NCT02294734|E1|Reported Event|Placebo|Participants received placebo two inhalations per day administered via a dry powder inhaler for a duration of 84 days.
644949|NCT02294682|B3|Baseline|Total|Total of all reporting groups
644950|NCT02294682|B2|Baseline|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644951|NCT02294682|B1|Baseline|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644952|NCT02294682|P2|Participant Flow|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644953|NCT02294682|P1|Participant Flow|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644954|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644955|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644956|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
645024|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
644957|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644958|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644959|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
645216|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
644960|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644961|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644962|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644963|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644964|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644965|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644966|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644967|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644968|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644969|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644970|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644971|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644972|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
645025|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
644973|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644974|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644975|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644976|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644977|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644978|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644979|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644980|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644981|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644982|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644983|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644984|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644985|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644986|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644987|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644988|NCT02294682|O2|Outcome|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
645026|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite).
644989|NCT02294682|O1|Outcome|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644990|NCT02294682|E2|Reported Event|GSK2140944 3000 mg|Participants were randomized to receive oral dose of GSK2140944 3000 mg (6 immediate-release capsules of 500 mg each) with food and 240 mL of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644991|NCT02294682|E1|Reported Event|GSK2140944 1500 mg|Participants were randomized to receive oral dose of GSK2140944 1500 mg (3 immediate-release capsules of 500 mg each) with food and 240 milliliters (mL) of water. Additional 100 mL of water was given to assist in swallowing a large number of capsules. Participants who tested positive for chlamydia trachomatis at the Baseline visit, received a single 1 gram dose of azithromycin or local standard of care at the TOC visit.
644994|NCT02294604|B2|Baseline|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
644995|NCT02294604|B1|Baseline|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
644996|NCT02294604|P3|Participant Flow|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
644997|NCT02294604|P2|Participant Flow|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
644998|NCT02294604|P1|Participant Flow|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
644999|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
645000|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
645001|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
645002|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
645003|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
645004|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
645005|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
645006|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
645007|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
645008|NCT02294604|O3|Outcome|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
645009|NCT02294604|O2|Outcome|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
645010|NCT02294604|O1|Outcome|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
645011|NCT02294604|E3|Reported Event|Group C|"Traditional scrub formation with 4% chlorhexidine~chlorhexidine"
645012|NCT02294604|E2|Reported Event|Group I|"Traditional scrub formation with 10 % povidone-iodine~povidone-iodine"
645013|NCT02294604|E1|Reported Event|Group R|"Waterless surgical hand rub formulation containing 61% ethyl alcochol, 1% chlorhexidine and moisturizers~ethyl alcochol, chlorhexidine and moisturizers"
645014|NCT02294461|B3|Baseline|Total|Total of all reporting groups
645015|NCT02294461|B2|Baseline|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645016|NCT02294461|B1|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645017|NCT02294461|P2|Participant Flow|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645018|NCT02294461|P1|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645019|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645020|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645021|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
645022|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
645023|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
645028|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645029|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
645030|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|Active metabolite.
645031|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
645032|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645033|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite.
645034|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite).
645035|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite.
645217|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645218|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
645036|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645037|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
645038|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
645039|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
645040|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645041|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
645042|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
645043|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
645044|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed.
645045|NCT02294461|O4|Outcome|Enzalutamide Plus M2|
645046|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
645047|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
645048|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645049|NCT02294461|O4|Outcome|Enzalutamide Plus M2|Active metabolite
645050|NCT02294461|O3|Outcome|M2- N-Desmethyl Enzalutamide|N-desmethyl enzalutamide (active metabolite)
645051|NCT02294461|O2|Outcome|M1- Carboxylic Acid Metabolite|Inactive metabolite
645052|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645053|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645054|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.disease progression were centrally confirmed.
645055|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645056|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645057|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645058|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645059|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645205|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645206|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
645060|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645061|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645062|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645219|NCT02291679|E3|Reported Event|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
645220|NCT02291679|E2|Reported Event|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645063|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645064|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645065|NCT02294461|O2|Outcome|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645066|NCT02294461|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645067|NCT02294461|E2|Reported Event|Placebo|Participants received matching placebo orally once a day until PSA progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645068|NCT02294461|E1|Reported Event|Enzalutamide|Participants received 160 mg of enzalutamide orally once a day until Prostate-Specific Antigen (PSA) progression and radiographic disease progression were centrally confirmed and 1 of the following 2 events became applicable to the participants: (1) initiation of cytotoxic chemotherapy or (2) initiation of an investigational agent for treatment of prostate cancer.
645069|NCT02294019|B1|Baseline|Ibuprofen|All participants who purchased at least 1 carton of study medication.
645070|NCT02294019|P1|Participant Flow|Ibuprofen|All participants who purchased at least 1 carton of study medication.
645071|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
645072|NCT02294019|O1|Outcome|Ibuprofen|Participants who purchased and used orally 400 mg caplets of Ibuprofen after reading the drug facts label (DFL), and recorded the use of study medication in the diary on or after the first purchase date, and returned the diary.
645073|NCT02294019|E1|Reported Event|Ibuprofen (Safety Population)|Subjects in the actual use population, and any other subject who provided any follow up information indicating that they used the study product at least once during the study
645074|NCT02293538|B3|Baseline|Total|Total of all reporting groups
645075|NCT02293538|B2|Baseline|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645076|NCT02293538|B1|Baseline|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645077|NCT02293538|P2|Participant Flow|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645078|NCT02293538|P1|Participant Flow|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645079|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645080|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645081|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645082|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645083|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645084|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645085|NCT02293538|O1|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645086|NCT02293538|O2|Outcome|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645087|NCT02293538|O1|Outcome|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645088|NCT02293538|E2|Reported Event|FID 114657|Formula Identification (FID) 114657 eye drops (10 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645089|NCT02293538|E1|Reported Event|Saline Control|Saline control eye drops (15 ml), 1-2 drops instilled in each eye 10 minutes prior to inserting a new pair of habitual contact lenses and after removing them, daily for 2 weeks.
645090|NCT02292433|B4|Baseline|Total|Total of all reporting groups
645221|NCT02291679|E1|Reported Event|Placebo|Matching placebo, once daily for 12 weeks
645091|NCT02292433|B3|Baseline|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
645092|NCT02292433|B2|Baseline|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
645093|NCT02292433|B1|Baseline|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
645094|NCT02292433|P3|Participant Flow|Placebo Then PF-04937319 100 mg Then PF-04937319 250 mg|Participants received placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the first intervention period followed by PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
645095|NCT02292433|P2|Participant Flow|PF-04937319 100 mg Then Placebo Then PF-04937319 250 mg|Participants received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the second intervention period, and then PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
645096|NCT02292433|P1|Participant Flow|PF-04937319 100 mg Then PF-04937319 250 mg Then Placebo|Participants received PF-04937319 100 milligram (mg) orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the first intervention period followed by PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon meal at approximately 5 hours of interval) for 7 days in the second intervention period, and then placebo matched to PF-04937319 administered orally with morning and afternoon meals for 7 days in the third intervention period. A washout period of 7 to 14 days was maintained between each intervention.
645097|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
645098|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645099|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645100|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
645101|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645102|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645103|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
645104|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645105|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645106|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
645222|NCT02291510|B5|Baseline|Total|Total of all reporting groups
645357|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
645107|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645108|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645109|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645110|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645111|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645112|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645113|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645114|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645115|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645116|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645117|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645118|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645119|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645120|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645121|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645122|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645123|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645124|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645125|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645126|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645127|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645207|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645128|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645129|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645223|NCT02291510|B4|Baseline|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
654457|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
645130|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645131|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645132|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645133|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645134|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645135|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645136|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645137|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645138|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645139|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645140|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645141|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645142|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645143|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645144|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645145|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645146|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645147|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645148|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645149|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645150|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645151|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
653877|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
645152|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645153|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645154|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645155|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645156|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645157|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
645158|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645159|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645160|NCT02292433|O3|Outcome|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
645161|NCT02292433|O2|Outcome|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645162|NCT02292433|O1|Outcome|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645163|NCT02292433|E3|Reported Event|Placebo|All participants who received placebo matched to PF-04937319 administered orally with morning meal and with afternoon meal for 7 days in either first, second or third intervention period.
645164|NCT02292433|E2|Reported Event|PF-­04937319 250 mg|All participants who received PF-04937319 250 mg orally per day in 2 divided doses (split dose regimen of 150 mg with morning meal and 100 mg with afternoon at approximately 5 hours of interval) for 7 days in either second or third intervention period.
645165|NCT02292433|E1|Reported Event|PF-­04937319 100 mg|All participants who received PF-04937319 100 mg orally per day in 2 divided doses (split dose regimen of 50 mg with morning meal and 50 mg with afternoon meal at approximately 5 hours of interval) for 7 days in either first or second intervention period.
645166|NCT02291718|B4|Baseline|Total|Total of all reporting groups
645167|NCT02291718|B3|Baseline|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
645168|NCT02291718|B2|Baseline|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
645169|NCT02291718|B1|Baseline|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
645170|NCT02291718|P3|Participant Flow|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
645171|NCT02291718|P2|Participant Flow|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
645172|NCT02291718|P1|Participant Flow|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
645173|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645174|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645175|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
645176|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645177|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645178|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
645179|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645180|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645181|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
645182|NCT02291718|O3|Outcome|Isovue 370 60mL|"Isovue 370 60mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645183|NCT02291718|O2|Outcome|Isovue 370 75mL|"Isovue 370 75mL injected 100 kVp 240 mAs~Isovue: iodine contrast"
645184|NCT02291718|O1|Outcome|Isovue 300 75mL|"Isovue 300 75mL injected 120 kVp 250 mAs~Isovue: iodine contrast"
645185|NCT02291718|E3|Reported Event|Isovue 370 (60mL)|60mL Isovue 370 injected 100 kVp, 240 mAs used to obtain CT
645186|NCT02291718|E2|Reported Event|Isovue 370 (75mL)|75mL Isovue 370 injected 100 kVp, 250 mAs used for obtaining CT
645187|NCT02291718|E1|Reported Event|Isovue 300 (75mL)|75mL Isovue 300 injected 120kvp, 250mAs used to obtain CT scan
645188|NCT02291679|B4|Baseline|Total|Total of all reporting groups
645189|NCT02291679|B3|Baseline|145 μg Linaclotide|145 μg oral linaclotide, once daily for 12 weeks
645190|NCT02291679|B2|Baseline|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645191|NCT02291679|B1|Baseline|Placebo|Matching placebo, once daily for 12 weeks
645208|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
645209|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645210|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
645211|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645212|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
645213|NCT02291679|O2|Outcome|72 μg Linaclotide|72 μg oral linaclotide, once daily for 12 weeks
645214|NCT02291679|O1|Outcome|Placebo|Matching placebo, once daily for 12 weeks
645224|NCT02291510|B3|Baseline|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
645225|NCT02291510|B2|Baseline|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
645226|NCT02291510|B1|Baseline|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
645227|NCT02291510|P4|Participant Flow|Sequence 4: DACB|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
645228|NCT02291510|P3|Participant Flow|Sequence 3: CDBA|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
645229|NCT02291510|P2|Participant Flow|Sequence 2: BCAD|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
645230|NCT02291510|P1|Participant Flow|Sequence 1: ABDC|Treatment A = 1000 mg Met IR BID Treatment B = 500 mg Met DR BID Treatment C = 1000 mg Met DR BID Treatment D = 2000 mg Met XR QD
645231|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
645232|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
645233|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
645234|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
645235|NCT02291510|O4|Outcome|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
645236|NCT02291510|O3|Outcome|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
645237|NCT02291510|O2|Outcome|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
645238|NCT02291510|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
645239|NCT02291510|E4|Reported Event|2000 mg Met XR QD|"Single dose of 2000 mg Metformin Extended-Release~Met XR: metformin extended-release tablets"
645240|NCT02291510|E3|Reported Event|1000 mg Met IR BID|"Two doses of 1000 mg Metformin Immediate-Release~Met IR: metformin immediate-release tablets"
645241|NCT02291510|E2|Reported Event|1000 mg Met DR BID|"Two doses of 1000 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
645242|NCT02291510|E1|Reported Event|500 mg Met DR BID|"Two doses of 500 mg Metformin Delayed-Release~Met DR: metformin delayed-release tablets"
645243|NCT02291419|B3|Baseline|Total|Total of all reporting groups
645244|NCT02291419|B2|Baseline|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645245|NCT02291419|B1|Baseline|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645246|NCT02291419|P2|Participant Flow|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645247|NCT02291419|P1|Participant Flow|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645248|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645249|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645250|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645251|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645252|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645253|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645254|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645255|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645256|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645257|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645258|NCT02291419|O2|Outcome|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645259|NCT02291419|O1|Outcome|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645260|NCT02291419|E2|Reported Event|Aspirin|"Patients in the aspirin arm will receive aspirin 81 mg daily orally~aspirin: aspirin 81 mg daily"
645261|NCT02291419|E1|Reported Event|Ticagrelor|"ticagrelor 90mg bid~ticagrelor: ticagrelor 90 mg bid"
645264|NCT02290821|B1|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
645265|NCT02290821|P2|Participant Flow|Placebo|"Placebo~diclofenac sodium gel 1%"
645266|NCT02290821|P1|Participant Flow|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
645267|NCT02290821|O2|Outcome|Placebo|"Placebo~diclofenac sodium gel 1%"
645268|NCT02290821|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
645269|NCT02290821|E2|Reported Event|Placebo|"Placebo~diclofenac sodium gel 1%"
645270|NCT02290821|E1|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1%~diclofenac sodium gel 1%"
645271|NCT02290509|B3|Baseline|Total|Total of all reporting groups
645272|NCT02290509|B2|Baseline|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
645273|NCT02290509|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
648648|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
645274|NCT02290509|P2|Participant Flow|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
645275|NCT02290509|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
645276|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
645277|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
645278|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
645279|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
645280|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
645281|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
645282|NCT02290509|O2|Outcome|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
645283|NCT02290509|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
645284|NCT02290509|E2|Reported Event|Inactivated Influenza Vaccine (IIV4)|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine (IIV4): Intramuscular injection of study vaccine"
645285|NCT02290509|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent: Intramuscular injection of study vaccine"
645286|NCT02289989|B3|Baseline|Total|Total of all reporting groups
645287|NCT02289989|B2|Baseline|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645288|NCT02289989|B1|Baseline|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645289|NCT02289989|P2|Participant Flow|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645346|NCT02289079|B2|Baseline|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
645290|NCT02289989|P1|Participant Flow|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645291|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645292|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645293|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645358|NCT02289079|E2|Reported Event|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
645294|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645295|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645296|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645297|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645298|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645299|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645300|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645301|NCT02289989|O2|Outcome|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645302|NCT02289989|O1|Outcome|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645303|NCT02289989|E2|Reported Event|Experimental: Oregano Extract Cream|"Intervention: Oregano extract cream for mild to moderate atopic dermatitis will be applied to the other patient's forearm~Oregano extract cream: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645304|NCT02289989|E1|Reported Event|Standard: Hydrocortisone 1% Ointment|"Intervention: hydrocortisone 1% ointment will be applied to one patient's forearm~Hydrocortisone: An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment"
645305|NCT02289755|B1|Baseline|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
645306|NCT02289755|P1|Participant Flow|ALLN-177|ALLN-177 (5 capsules; 7,500 units/meal) by mouth 3 times a day with main meals for 4 consecutive days.
645307|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
645308|NCT02289755|O1|Outcome|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
645309|NCT02289755|E1|Reported Event|ALLN-177|ALLN-177 (5 capsules: 7,500 units/meal), 3 times a day with meals, 4 days
645310|NCT02289742|B3|Baseline|Total|Total of all reporting groups
645311|NCT02289742|B2|Baseline|Astigmats|Nelfilcon A contact lenses (toric and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
645312|NCT02289742|B1|Baseline|Presbyopes|Nelfilcon A contact lenses (multifocal and sphere) worn as randomized in a crossover design during Periods 1 and 2, with nelfilcon A sphere contact lenses in Period 3. Each product worn bilaterally (in both eyes) for 12 hours.
645313|NCT02289742|P4|Participant Flow|Astigmats Sphere/Toric|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A toric contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
645314|NCT02289742|P3|Participant Flow|Astigmats Toric/Sphere|Nelfilcon A toric contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
645315|NCT02289742|P2|Participant Flow|Presbyopes Sphere/MF|Nelfilcon A sphere contact lenses in Periods 1 and 3, with nelfilcon A multifocal contact lenses in Period 2. Each product worn bilaterally (in both eyes) for 12 hours.
645316|NCT02289742|P1|Participant Flow|Presbyopes MF/Sphere|Nelfilcon A multifocal contact lenses in Period 1, followed by nelfilcon A sphere contact lenses in Periods 2 and 3. Each product worn bilaterally (in both eyes) for 12 hours.
645317|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
645318|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 ( in a crossover design)
645319|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
645320|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
645321|NCT02289742|O4|Outcome|Astigmats / Sphere|Nelfilcon A spherical contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
645322|NCT02289742|O3|Outcome|Astigmats / Toric|Nelfilcon A toric contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design)
645323|NCT02289742|O2|Outcome|Presbyopes / Sphere|Nelfilcon A spherical contact lenses worn balaterally (in both eyes) for 12 hours during Period 1 or Period 2 (in a crossover design) and in Period 3
645324|NCT02289742|O1|Outcome|Presbyopes / Multifocal|Nelfilcon A multifocal contact lenses worn bilaterally (in both eyes) for 12 hours during Period 1 or 2
645325|NCT02289742|E7|Reported Event|Astigmats / Sphere Second Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
645326|NCT02289742|E6|Reported Event|Astigmats / Sphere First Exposure|All astigmats exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
645327|NCT02289742|E5|Reported Event|Astigmats / Toric|All subjects exposed to nelfilcon A toric contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
645328|NCT02289742|E4|Reported Event|Presbyopes / Sphere Second Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 3
645329|NCT02289742|E3|Reported Event|Presbyopes / Sphere First Exposure|All presbyopes exposed to nelfilcon A spherical contact lenses, worn bilaterally (in both eyes) for 12 hours during Period 1 or Period 2 as randomized
645330|NCT02289742|E2|Reported Event|Presbyopes / Multifocal|All subjects exposed to nelfilcon A multifocal contact lenses, worn bilaterally (in both eyes) for 12 hours during Periods 1 or 2 as randomized
645331|NCT02289742|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
645332|NCT02289105|B3|Baseline|Total|Total of all reporting groups
645333|NCT02289105|B2|Baseline|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
645334|NCT02289105|B1|Baseline|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
645335|NCT02289105|P2|Participant Flow|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
645336|NCT02289105|P1|Participant Flow|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
645337|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
645338|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
645339|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
645340|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
645341|NCT02289105|O2|Outcome|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
645342|NCT02289105|O1|Outcome|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
645343|NCT02289105|E2|Reported Event|Control|Participants in the control group could choose to: complete an AD, confirm prior AD completion, or skip the task.
645344|NCT02289105|E1|Reported Event|Mandatory Active Choice|"The mandatory active choice group could choose to: complete an AD, confirm prior completion of an AD, or complete a form declining AD completion and indicate their reason(s) for doing so.~Mandatory active choice: the mandatory active choice group, unlike the control group, could not simply skip the task. If they didn't want to complete an AD, they had to fill out a declination form."
645345|NCT02289079|B3|Baseline|Total|Total of all reporting groups
645405|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645347|NCT02289079|B1|Baseline|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
645348|NCT02289079|P2|Participant Flow|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
645349|NCT02289079|P1|Participant Flow|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
645350|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
645351|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
645352|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
645353|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
645354|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
645355|NCT02289079|O1|Outcome|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
645356|NCT02289079|O2|Outcome|Bupivacaine TAP|"These patients receive a subcostal TAP with bupivacaine~Bupivacaine"
645359|NCT02289079|E1|Reported Event|Liposomal Bupivacaine TAP|"these patients receive a subcostal TAP with liposomal bupivacaine~liposomal bupivacaine"
645360|NCT02288364|B3|Baseline|Total|Total of all reporting groups
645361|NCT02288364|B2|Baseline|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645362|NCT02288364|B1|Baseline|1% Lidocaine|1% Lidocaine alone.
645363|NCT02288364|P2|Participant Flow|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645364|NCT02288364|P1|Participant Flow|1% Lidocaine|1% Lidocaine alone.
645365|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645366|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645367|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645368|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645369|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645370|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645371|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645372|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645373|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645374|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645375|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645376|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645377|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645378|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645379|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645380|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645381|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645382|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645383|NCT02288364|O2|Outcome|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645384|NCT02288364|O1|Outcome|1% Lidocaine|1% Lidocaine alone.
645385|NCT02288364|E2|Reported Event|1% Lidocaine Plus Sodium Bicarbonate|1% Lidocaine plus 8.4% sodium bicarbonate
645386|NCT02288364|E1|Reported Event|1% Lidocaine|1% Lidocaine alone.
645387|NCT02288312|B4|Baseline|Total|Total of all reporting groups
645388|NCT02288312|B3|Baseline|Sequence C|Period 1 - ESL 800 mg, in fed Period 2 - ESL 800 mg (2x400mg), in fasting Period 3 - ESL 800 mg, in fasting
645389|NCT02288312|B2|Baseline|Sequence B|Period 1 - ESL 800 mg (2x400mg), in fasting Period 2 - ESL 800 mg, in fasting Period 3 - ESL 800 mg, in fed
645390|NCT02288312|B1|Baseline|Sequence A|Period 1 - ESL 800 mg, in fasting Period 2 - ESL 800 mg, in fed Period 3 - ESL 800 mg (2x400mg), in fasting
645391|NCT02288312|P3|Participant Flow|Group C|"Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)~Washout periods - 7 days between dosing days"
645392|NCT02288312|P2|Participant Flow|Group B|"Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)~Washout periods - 7 days between dosing days"
645393|NCT02288312|P1|Participant Flow|Group A|"Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)~Washout periods - 7 days between dosing days"
645394|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
645395|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645396|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645397|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
645398|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645399|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645400|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
645401|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645402|NCT02288312|O1|Outcome|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645403|NCT02288312|O3|Outcome|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
645404|NCT02288312|O2|Outcome|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645406|NCT02288312|E3|Reported Event|BIA 2-093 800 mg (2 x 400 mg)|"Tablets 2 x 400 mg. Administration:Oral.~BIA 2-093"
645407|NCT02288312|E2|Reported Event|BIA 2-093 800 mg Fed|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645408|NCT02288312|E1|Reported Event|BIA 2-093 800 mg Fasting|"Tablets 800 mg. Administration:Oral.~BIA 2-093"
645409|NCT02288273|B3|Baseline|Total|Total of all reporting groups
645410|NCT02288273|B2|Baseline|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
645411|NCT02288273|B1|Baseline|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
645412|NCT02288273|P2|Participant Flow|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
645413|NCT02288273|P1|Participant Flow|Once Weekly (EQW) + Met|Bydureon EQW + Metformin XR 1500-2000 mg
645414|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
645415|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
645416|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
645417|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
645418|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
645419|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
645420|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
645421|NCT02288273|O1|Outcome|EQW + Met|Bydureon EQW + Metformin 1500-2000 mg
645422|NCT02288273|O2|Outcome|Placebo + Met|Placebo + Metformin 1500 + 2000 mg
645431|NCT02287779|B8|Baseline|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645432|NCT02287779|B7|Baseline|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645433|NCT02287779|B6|Baseline|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645434|NCT02287779|B5|Baseline|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645435|NCT02287779|B4|Baseline|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645436|NCT02287779|B3|Baseline|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
645437|NCT02287779|B2|Baseline|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
645438|NCT02287779|B1|Baseline|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
645439|NCT02287779|P8|Participant Flow|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645440|NCT02287779|P7|Participant Flow|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645441|NCT02287779|P6|Participant Flow|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645442|NCT02287779|P5|Participant Flow|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645443|NCT02287779|P4|Participant Flow|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645444|NCT02287779|P3|Participant Flow|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
645445|NCT02287779|P2|Participant Flow|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
645446|NCT02287779|P1|Participant Flow|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645447|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645448|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645449|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645450|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645451|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645452|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
645453|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
645454|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645455|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645456|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645457|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645547|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645458|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645459|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645460|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645461|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645462|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645463|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645464|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645465|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645466|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645467|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645468|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645469|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645470|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645471|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645472|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645473|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645474|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645475|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645476|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645477|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645478|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645479|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645480|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645481|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645482|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645483|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645484|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645485|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645486|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645487|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645488|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645489|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645490|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645491|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645492|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645493|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645494|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645495|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645496|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645497|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645498|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645499|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645500|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645501|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645502|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days
645503|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645504|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645505|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645506|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645507|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645508|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645509|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645510|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645511|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645512|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645513|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645514|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645515|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645516|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645517|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645518|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645519|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645520|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645521|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645522|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645523|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645524|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
645525|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645526|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645527|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645528|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645529|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645530|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645531|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645532|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
645533|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645534|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645535|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645536|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645537|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645538|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645539|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645540|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645541|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645542|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645543|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645544|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645545|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645546|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645548|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
645549|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645550|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645551|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645552|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645553|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645554|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645555|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645556|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally QD for 12 days.
645557|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645558|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645559|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645560|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645561|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645562|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645563|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645564|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
645565|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645566|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645567|NCT02287779|O8|Outcome|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645568|NCT02287779|O7|Outcome|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645569|NCT02287779|O6|Outcome|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645570|NCT02287779|O5|Outcome|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645571|NCT02287779|O4|Outcome|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645572|NCT02287779|O3|Outcome|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule orally once a day (QD) for 12 days.
645573|NCT02287779|O2|Outcome|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 milligram (mg) capsule orally twice a day (BID) for 12 days.
645574|NCT02287779|O1|Outcome|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645575|NCT02287779|E8|Reported Event|Volixibat 80-40-20 mg QD|Participants received volixibat (SHP626) 80 mg capsule orally QD on Day 1, 40 mg capsule orally QD on Day 2, and 20 mg capsule orally QD on Days 3-12.
645576|NCT02287779|E7|Reported Event|Volixibat 40 mg QD|Participants received volixibat (SHP626) 40 mg capsule orally QD for 12 days.
645577|NCT02287779|E6|Reported Event|Volixibat 30 mg QD|Participants received volixibat (SHP626) 30 mg capsule orally QD for 12 days.
645578|NCT02287779|E5|Reported Event|Volixibat 2-5-10-20 mg QD|Participants received volixibat (SHP626) 2 mg capsule orally QD on Days 1-3, 5 mg capsule orally QD on Days 4-6, 10 mg capsule QD orally on Days 7-9, and 20 mg capsule QD orally on Days 10-12.
645579|NCT02287779|E4|Reported Event|Volixibat 20 mg QD|Participants received volixibat (SHP626) 20 mg capsule orally QD for 12 days.
645580|NCT02287779|E3|Reported Event|Volixibat 10 mg QD|Participants received volixibat (SHP626) 10 mg capsule QD for 12 days.
645581|NCT02287779|E2|Reported Event|Volixibat 5 mg BID|Participants received volixibat (SHP626) 5 mg capsule orally BID for 12 days.
645582|NCT02287779|E1|Reported Event|Placebo|Participants received placebo matched to volixibat tablet orally for 12 days.
645583|NCT02287623|B3|Baseline|Total|Total of all reporting groups
645584|NCT02287623|B2|Baseline|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645585|NCT02287623|B1|Baseline|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645586|NCT02287623|P2|Participant Flow|Bupivacaine TAP|Patients will receive a TAP block with bupivacaine bupivacaine: patients will receive a tap with bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine.
645587|NCT02287623|P1|Participant Flow|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine in the preoperative area before the kidney donation. This occurred under ultrasound guidance with the patient sedated. the patient received 30 mL total per tap. Each TAP consisted of 10 mL of liposomal bupivacaine and 20 mL of normal saline."
645588|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645589|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645590|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645591|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645592|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645593|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645594|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645595|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645596|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645597|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645598|NCT02287623|O2|Outcome|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645599|NCT02287623|O1|Outcome|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645600|NCT02287623|E2|Reported Event|Bupivacaine TAP|"Patients will receive a TAP block with bupivacaine~bupivacaine: patients will receive a tap with bupivacaine"
645601|NCT02287623|E1|Reported Event|Liposomal Bupivacaine TAP|"Patients will receive a TAP block with liposomal bupivacaine~liposomal bupivacaine: patients will receive a tap with liposomal bupivacaine"
645602|NCT02287610|B1|Baseline|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645603|NCT02287610|P1|Participant Flow|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645604|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645605|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645606|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645607|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645608|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645609|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645610|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645611|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645612|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645613|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645614|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
648120|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
645615|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645616|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645617|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645618|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645619|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645620|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645649|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645650|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645621|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645622|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645623|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645624|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645625|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645626|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645627|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645628|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645629|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645630|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645631|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645632|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645633|NCT02287610|O1|Outcome|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645634|NCT02287610|E1|Reported Event|Delayed-release Prednisone (RAYOS)|Adult Rheumatoid Arthritis (RA) participants previously receiving immediate release prednisone were enrolled in the trial if they and their physicians both consented. Once entered, participant baseline data were captured and they were switched to delayed-release prednisone at the same dose of prednisone previously received.
645635|NCT02287415|B1|Baseline|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
645636|NCT02287415|P1|Participant Flow|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
645637|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
645638|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
645639|NCT02287415|O1|Outcome|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
645640|NCT02287415|E1|Reported Event|Group 1|"Phase A: Warfarin Phase B: Warfarin + BIA 2-093 (ESL) Phase C: Warfarin~BIA 2-093~Warfarin"
645641|NCT02287402|B1|Baseline|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645642|NCT02287402|P1|Participant Flow|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645643|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645644|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645645|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645646|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645647|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645648|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645651|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645652|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645653|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645654|NCT02287402|O1|Outcome|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645655|NCT02287402|E1|Reported Event|AO-128 0.6 mg|One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
645656|NCT02286518|B15|Baseline|Total|Total of all reporting groups
645657|NCT02286518|B14|Baseline|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645658|NCT02286518|B13|Baseline|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645659|NCT02286518|B12|Baseline|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645660|NCT02286518|B11|Baseline|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645661|NCT02286518|B10|Baseline|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645662|NCT02286518|B9|Baseline|Part 2 Cohort 4: TAK-114 20 mg Fed + TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, once on Day 1, fed state in period 2 (3 days), followed by a 14 day washout period, further followed by TAK-114 20 mg, capsule, orally, once on Day 1 in fasted state in period 1, in healthy Japanese participants.
645663|NCT02286518|B8|Baseline|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
645664|NCT02286518|B7|Baseline|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645665|NCT02286518|B6|Baseline|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645666|NCT02286518|B5|Baseline|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645667|NCT02286518|B4|Baseline|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645668|NCT02286518|B3|Baseline|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645669|NCT02286518|B2|Baseline|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645670|NCT02286518|B1|Baseline|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645671|NCT02286518|P14|Participant Flow|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645672|NCT02286518|P13|Participant Flow|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645673|NCT02286518|P12|Participant Flow|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645674|NCT02286518|P11|Participant Flow|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645675|NCT02286518|P10|Participant Flow|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645676|NCT02286518|P9|Participant Flow|Part 2 Cohort 4: TAK-114 Fed + TAK-114 Fasted|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 2 (3 days), in Japanese participants.
645677|NCT02286518|P8|Participant Flow|Part 2- Cohort 4: TAK-114 Fasted + TAK-114Fed|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of Period 1 (3 days), followed by 14 days washout period, followed by TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of Period 2 (3 days), in Japanese participants.
645678|NCT02286518|P7|Participant Flow|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645679|NCT02286518|P6|Participant Flow|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645680|NCT02286518|P5|Participant Flow|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645681|NCT02286518|P4|Participant Flow|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645682|NCT02286518|P3|Participant Flow|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645683|NCT02286518|P2|Participant Flow|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645684|NCT02286518|P1|Participant Flow|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645685|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
648649|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
645686|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645687|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645688|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645689|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645690|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645691|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645692|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645693|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645694|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645695|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645696|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645697|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645698|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645699|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645700|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645701|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645702|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645703|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645704|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645705|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645706|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645707|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645708|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645709|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645710|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645711|NCT02286518|O4|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645712|NCT02286518|O3|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645713|NCT02286518|O2|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645714|NCT02286518|O1|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645715|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645716|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645717|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645718|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645719|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645720|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645721|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645722|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645723|NCT02286518|O12|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645724|NCT02286518|O11|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645725|NCT02286518|O10|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645726|NCT02286518|O9|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645727|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645728|NCT02286518|O7|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645729|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645730|NCT02286518|O5|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645731|NCT02286518|O4|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645732|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645733|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645734|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645735|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645736|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645737|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645738|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645739|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645740|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645741|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645742|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645743|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645744|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645745|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
653878|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
645746|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645747|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645748|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645749|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645750|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645751|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645752|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645753|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645754|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645755|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645756|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645757|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645758|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645759|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645760|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645761|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645762|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645763|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645764|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645765|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645766|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645767|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645768|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645769|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645770|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645771|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645772|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645773|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645774|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645775|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645776|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645777|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645778|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645779|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645780|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645781|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645817|NCT02286518|E6|Reported Event|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645782|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645783|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645784|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645785|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645786|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645787|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645788|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645789|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645790|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645791|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645792|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645793|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645794|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645795|NCT02286518|O14|Outcome|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645796|NCT02286518|O13|Outcome|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645797|NCT02286518|O12|Outcome|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645798|NCT02286518|O11|Outcome|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645799|NCT02286518|O10|Outcome|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645800|NCT02286518|O9|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645801|NCT02286518|O8|Outcome|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645802|NCT02286518|O7|Outcome|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645803|NCT02286518|O6|Outcome|Part 1 SRD-Cohort 2B: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645804|NCT02286518|O5|Outcome|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645805|NCT02286518|O4|Outcome|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645806|NCT02286518|O3|Outcome|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645807|NCT02286518|O2|Outcome|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645808|NCT02286518|O1|Outcome|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645809|NCT02286518|E14|Reported Event|Part 3 Cohort 6B MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645810|NCT02286518|E13|Reported Event|Part 3 Cohort 5B MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Caucasian participants.
645811|NCT02286518|E12|Reported Event|Part 3 Cohort 6A MRD: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645812|NCT02286518|E11|Reported Event|Part 3 Cohort 5A MRD: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645813|NCT02286518|E10|Reported Event|Part 3 Placebo Cohort 5A – 6A: Placebo|TAK-114 placebo-matching, capsule, orally, twice daily on Days 1-9 and once only in the morning of Day 10 of the 10 days treatment period, in Japanese participants.
645814|NCT02286518|E9|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fed|TAK-114 20 mg, capsule, orally, in fed condition (after food), once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645815|NCT02286518|E8|Reported Event|Part 2 Cohort 4: TAK-114 20 mg Fasted|TAK-114 20 mg, capsule, orally, in fasted condition, once on Day 1 of either Period 1 or 2 of 3 days, in Japanese participants.
645816|NCT02286518|E7|Reported Event|Part 1 SRD-Cohort 3B: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645963|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645818|NCT02286518|E5|Reported Event|Part 1 SRD - Cohort 1B : TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Caucasian participants.
645819|NCT02286518|E4|Reported Event|Part 1 SRD-Cohort 3A: TAK-114 50 mg|TAK-114 50 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645820|NCT02286518|E3|Reported Event|Part 1 SRD-Cohort 2A: TAK-114 20 mg|TAK-114 20 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645821|NCT02286518|E2|Reported Event|Part 1 SRD-Cohort 1A: TAK-114 10 mg|TAK-114 10 mg, capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645822|NCT02286518|E1|Reported Event|Part 1 SRD-Cohort 1A – 3A: Placebo|TAK-114 placebo-matching capsule, orally, once on Day 1 in the 3 days treatment period, in Japanese participants.
645823|NCT02286193|B1|Baseline|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
645824|NCT02286193|P1|Participant Flow|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
645825|NCT02286193|O1|Outcome|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
645826|NCT02286193|O1|Outcome|Patients Presenting to Community Liaison|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
645827|NCT02286193|E1|Reported Event|Patients Presenting to Community Resource Specialist (CRS)|Primary care patients who are referred or self-refer to the CRS for education and linkage to community resources that can help support health goals
645828|NCT02285998|B3|Baseline|Total|Total of all reporting groups
645865|NCT02284880|P3|Participant Flow|800 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
645829|NCT02285998|B2|Baseline|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645830|NCT02285998|B1|Baseline|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645831|NCT02285998|P2|Participant Flow|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645832|NCT02285998|P1|Participant Flow|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645833|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645834|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645835|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645836|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645837|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645838|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645839|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645840|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645841|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645842|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
646046|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
645843|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645844|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645845|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645846|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645847|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645848|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645910|NCT02284854|E1|Reported Event|CBZ 200 mg|Group B CBZ 200 mg
645849|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645850|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645851|NCT02285998|O2|Outcome|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645852|NCT02285998|O1|Outcome|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645853|NCT02285998|E2|Reported Event|Inactivated Influenza Vaccine|"Intramuscular injection of vaccine contains 4 x 15µg (60µg total) of HA derived from the same influenza A/H1N1 and A/H3N2 and influenza B strains in a total volume of 0.5mL.~Inactivated Influenza Vaccine: Intramuscular injection of vaccine"
645854|NCT02285998|E1|Reported Event|Flublok Quadrivalent Influenza Vaccine|"Intramuscular injection of vaccine containing 4 x 45µg (180µg total) of each recombinant hemagglutinin (rHA) derived from influenza A/H1N1 and A/H3N2 and two lineages of influenza B viruses identified for the season in which the trial is conducted in a total volume of 0.5 mL~Flublok Quadrivalent Influenza Vaccine: Intramuscular injection of vaccine"
645855|NCT02285270|B1|Baseline|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
645856|NCT02285270|P1|Participant Flow|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
645857|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
645858|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
648376|NCT02252744|P1|Participant Flow|RA Patients|Adult patients diagnosed with rheumatoid arthritis
645859|NCT02285270|O1|Outcome|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
645860|NCT02285270|E1|Reported Event|Single Group Assignment|"Diagnostic test/procedure - FDG PET/CT~FDG PET/CT: PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan."
645861|NCT02284880|B3|Baseline|Total|Total of all reporting groups
645862|NCT02284880|B2|Baseline|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
645863|NCT02284880|B1|Baseline|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
645864|NCT02284880|P4|Participant Flow|800 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
645866|NCT02284880|P2|Participant Flow|400 mg BIA 2-093 Group 2|In Group 2, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: TBM first, then MF
645867|NCT02284880|P1|Participant Flow|400 mg BIA 2-093 Group 1|In Group 1, subjects received on period 1 and 2: 400 mg BIA 2-093 ESL: MF first, then TBM
645868|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
645869|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
645870|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
645871|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
645872|NCT02284880|O2|Outcome|800 mg BIA 2-093|In Group 2, subjects received randomly on period 1 and period 2, either a single 800 mg tablet of ESL (MF), or a single 800 mg dose of ESL (TBM).
645873|NCT02284880|O1|Outcome|400 mg BIA 2-093|In Group 1, subjects received randomly on period 1 and 2, either a single 400 mg tablet of ESL (MF), or a single 400 mg tablet of ESL (TBM).
645874|NCT02284880|E6|Reported Event|After Follow-up Visit|After Follow-up visit ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation TBM - To be marketed
645875|NCT02284880|E5|Reported Event|800 mg Tablet of ESL (TBM)|800 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
645876|NCT02284880|E4|Reported Event|800 mg Tablet of ESL (MF)|800 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
645877|NCT02284880|E3|Reported Event|400 mg Tablet of ESL (TBM)|400 mg tablet of ESL (TBM) ESL - Eslicarbazepine acetate, BIA 2-093 TBM - To be marketed
645878|NCT02284880|E2|Reported Event|400 mg Tablet of ESL (MF)|400 mg tablet of ESL (MF) ESL - Eslicarbazepine acetate, BIA 2-093 MF - Marketed formulation
645879|NCT02284880|E1|Reported Event|Before Treatment|Before treatment with ESL ESL - Eslicarbazepine acetate, BIA 2-093
645880|NCT02284867|B3|Baseline|Total|Total of all reporting groups
645881|NCT02284867|B2|Baseline|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645882|NCT02284867|B1|Baseline|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645883|NCT02284867|P2|Participant Flow|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645884|NCT02284867|P1|Participant Flow|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645885|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645911|NCT02284828|B1|Baseline|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645912|NCT02284828|P1|Participant Flow|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645913|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645886|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645887|NCT02284867|O2|Outcome|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645888|NCT02284867|O1|Outcome|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645889|NCT02284867|E2|Reported Event|Term Labor|"Patient delivered vaginally at term with no history of having tocolysis for preterm labor at the current pregnancy .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645890|NCT02284867|E1|Reported Event|Preterm Labor|"Patients who has threatened preterm labor and will receive tocolysis and these patients will either not respond to tocolysis and delivered preterm or will respond to tocolysis and will deliver at term .~immunohistochemistry study: After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24–48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department."
645891|NCT02284854|B3|Baseline|Total|Total of all reporting groups
645892|NCT02284854|B2|Baseline|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + 400 mg twice-daily
645893|NCT02284854|B1|Baseline|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645894|NCT02284854|P2|Participant Flow|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645895|NCT02284854|P1|Participant Flow|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645896|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645897|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645898|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645899|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645900|NCT02284854|O1|Outcome|Group B|Day 1 to Day 8 - CBZ 200 mg Day 9 to Day 14 - CBZ 400 mg Day 15 to Day 29 - CBZ 400 mg twice-daily Day 30 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645901|NCT02284854|O1|Outcome|Group A|Day 1 to Day 8 - BIA 2-093 800 mg Day 9 to Day 14 - BIA 2-093 800 mg + CBZ 200 mg Day 15 to Day 22 - BIA 2-093 800 mg + CBZ 400 mg Day 23 to Day 35 - BIA 2-093 800 mg + CBZ 400 mg twice-daily
645902|NCT02284854|E9|Reported Event|After Treatment|Group A and B After treatment
645903|NCT02284854|E8|Reported Event|Before Treatment|Group A and B Before treatment
645904|NCT02284854|E7|Reported Event|ESL 800 mg + CBZ 400 mg|Group A ESL 800 mg + CBZ 400 mg
645905|NCT02284854|E6|Reported Event|ESL 800 mg + CBZ 200 mg|Group A ESL 800 mg + CBZ 200 mg
645906|NCT02284854|E5|Reported Event|ESL 800 mg|Group A ESL 800 mg
645907|NCT02284854|E4|Reported Event|ESL 800 mg + CBZ 400 mg Twice-daily|Group A + B ESL 800 mg + CBZ 400 mg twice-daily
645908|NCT02284854|E3|Reported Event|CBZ 400 mg Twice-daily|Group B CBZ 400 mg twice-daily
645909|NCT02284854|E2|Reported Event|CBZ 400 mg|Group B CBZ 400 mg
645914|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645915|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645916|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645917|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645918|NCT02284828|O1|Outcome|Group 1 BIA 2-093|A single dose of oral BIA 2-093 900 mg was followed by consecutive 7-day periods of: Placebo, ESL 800 mg, and ESL 1200 mg.
645919|NCT02284828|E4|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
645920|NCT02284828|E3|Reported Event|BIA 2-093 800 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
645921|NCT02284828|E2|Reported Event|Placebo|Placebo, PLC
645922|NCT02284828|E1|Reported Event|BIA 2-093 900 mg|BIA 2-093 - ESL, Eslicarbazepine acetate
645923|NCT02284555|B1|Baseline|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
645924|NCT02284555|P1|Participant Flow|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
645925|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
645926|NCT02284555|O1|Outcome|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
645927|NCT02284555|E1|Reported Event|Mupirocin 2% Nasal Ointment|"Mupirocin (Bactroban 2% nasal ointment) will be administered twice daily for 5 days in accordance with the Summary of Product Characteristics (SmPC).~Mupirocin: Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC."
645928|NCT02284516|B3|Baseline|Total|Total of all reporting groups
645929|NCT02284516|B2|Baseline|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645930|NCT02284516|B1|Baseline|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645931|NCT02284516|P2|Participant Flow|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645932|NCT02284516|P1|Participant Flow|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645933|NCT02284516|O2|Outcome|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645934|NCT02284516|O1|Outcome|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645935|NCT02284516|O2|Outcome|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645936|NCT02284516|O1|Outcome|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645937|NCT02284516|E2|Reported Event|Lifitegrast|Lifitegrast 5% Ophthalmic Solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
645938|NCT02284516|E1|Reported Event|Placebo|Placebo ophthalmic solution was administered to the ocular surface as a single eye drop twice daily in both eyes for 84 days.
646208|NCT02281591|E3|Reported Event|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
645939|NCT02284386|B1|Baseline|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645940|NCT02284386|P1|Participant Flow|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645941|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645942|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645943|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645979|NCT02284165|P3|Participant Flow|Discharged Home|Discharged from hospital to home with or without services
645980|NCT02284165|P2|Participant Flow|Skilled Nursing Facility (SNF)|Discharged from hospital to skilled nursing facility
654458|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
645944|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645945|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645946|NCT02284386|O1|Outcome|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645947|NCT02284386|E1|Reported Event|Bupivacaine SNB + EXPAREL Infiltration|"Spinal block with bupivacaine HCl 7.5 mg/mL. Local infiltration of EXPAREL 266 mg.~Bupivacaine SNB: SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.~EXPAREL Infiltration: Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure."
645948|NCT02284347|B1|Baseline|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
645949|NCT02284347|P1|Participant Flow|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
645950|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
645951|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
645952|NCT02284347|O1|Outcome|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
645953|NCT02284347|E1|Reported Event|NuVent™|"Revision patients treated with NuVent™~Electromagnetic Sinus Dilation System (NuVent™): NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia."
645954|NCT02284243|B3|Baseline|Total|Total of all reporting groups
645955|NCT02284243|B2|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645956|NCT02284243|B1|Baseline|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645957|NCT02284243|P2|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645958|NCT02284243|P1|Participant Flow|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645959|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645960|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645961|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645962|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645964|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645965|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645966|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645967|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645968|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645969|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645970|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645971|NCT02284243|O2|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645972|NCT02284243|O1|Outcome|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645973|NCT02284243|E2|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours.~Intranasal Placebo"
645974|NCT02284243|E1|Reported Event|DEX-IN 50mcg|"DEX-IN (Intranasal dexmedetomidine) 50mcg every 6 hours for 48 hours.~Intranasal Dexmedetomidine"
645975|NCT02284165|B4|Baseline|Total|Total of all reporting groups
645976|NCT02284165|B3|Baseline|Discharged Home|Discharged from hospital to home with or without services
645977|NCT02284165|B2|Baseline|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
645978|NCT02284165|B1|Baseline|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
654459|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
645981|NCT02284165|P1|Participant Flow|Inpatient Rehab Facility (IRF)|Discharged from hospital to inpatient rehabilitation facility
645982|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
645983|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
645984|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
645985|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
645986|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
645987|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
645988|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
645989|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
645990|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
645991|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
645992|NCT02284165|O2|Outcome|Skilled Nursing Facility (SNF)|Discharged from hospital to Skilled Nursing Facility
645993|NCT02284165|O1|Outcome|Inpatient Rehab Facility (IRF)|Discharged from hospital to Inpatient Rehabilitation Facility
645994|NCT02284165|O1|Outcome|All Patients|Examined descriptively for all patients in the study in order to differentiate the different types of rehabilitation services for the full stroke patient population.
645995|NCT02284165|E1|Reported Event|All Patients|Not applicable. This was a retrospective analysis of pre-existing data for acute ischemic stroke patients in the Get With the Guidelines registry with 12-month follow-up as part of the Adherence Evaluation After Ischemic Stroke Longitudinal (AVAIL) registry.
645996|NCT02283840|B4|Baseline|Total|Total of all reporting groups
645997|NCT02283840|B3|Baseline|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
645998|NCT02283840|B2|Baseline|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
645999|NCT02283840|B1|Baseline|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646000|NCT02283840|P3|Participant Flow|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646001|NCT02283840|P2|Participant Flow|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646002|NCT02283840|P1|Participant Flow|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646003|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646004|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646005|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646006|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646007|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646008|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646009|NCT02283840|O3|Outcome|Cohort C:BIA 2-093 800 mg|"One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646010|NCT02283840|O2|Outcome|Cohort B:BIA 2-093 600 mg|"One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646011|NCT02283840|O1|Outcome|Cohort A:BIA 2-093 400 mg|"One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (To-Be-Marketed Formulation, TBM)~One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)~BIA 2-093"
646012|NCT02283840|E6|Reported Event|Reference 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg tablet (Clinical Trial Formulation, CTF)
646013|NCT02283840|E5|Reported Event|Reference 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg tablet (Clinical Trial Formulation, CTF)
646014|NCT02283840|E4|Reported Event|Reference 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg tablet (Clinical Trial Formulation, CTF)
646015|NCT02283840|E3|Reported Event|Test 3|One Eslicarbazepine acetate (BIA 2-093) 800 mg To-Be-Marketed Formulation, TBM
646016|NCT02283840|E2|Reported Event|Test 2|One Eslicarbazepine acetate (BIA 2-093) 600 mg To-Be-Marketed Formulation, TBM
646017|NCT02283840|E1|Reported Event|Test 1|One Eslicarbazepine acetate (BIA 2-093) 400 mg To-Be-Marketed Formulation, TBM
646018|NCT02283827|B3|Baseline|Total|Total of all reporting groups
646019|NCT02283827|B2|Baseline|Group B BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 100 mg PHT for 2 days; Treatment 1: 300 mg PHT 6 days; Treatment 2: 600 mg ESL + PHT 300 mg for 2 days; Treatment 3: 1200 mg ESL and PHT 300 mg for 17 days
648650|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
646020|NCT02283827|B1|Baseline|Group A BIA 2-093 + Phenytoin (PHT)|Pre-treatment: 600 mg ESL, 2 days; Treatment 1: 1200 mg ESL 6 days Treatment 2: 1200 mg ESL and PHT 100 mg for 2 days Treatment 3: 1200 mg ESL and PHT 300 mg for17 days
646021|NCT02283827|P2|Participant Flow|Group B BIA 2-093 + Phenytoin (PHT)|"Day 1 to 2: Pre-treatment 2: PHT 100 mg Day 3 to 8: Treatment 2: PHT 300 mg Day 9 to 10: Treatment 2 + Pre-treatment 1: PHT 300 mg~+ ESL 600 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg"
646022|NCT02283827|P1|Participant Flow|Group A BIA 2-093 + Phenytoin (PHT)|Day 1 to 2: Pre-treatment 1: ESL 600 mg Day 3 to 8: Treatment 1:1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ PHT 100 mg Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + PHT 300 mg
646023|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
646024|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
646025|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
646026|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin (PHT)|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
646027|NCT02283827|O2|Outcome|BIA 2-093|BIA 2-093 - ESL, Eslicarbazepine
646028|NCT02283827|O1|Outcome|BIA 2-093 + Phenytoin|Phenytoin - PHT; BIA 2-093 - ESL, Eslicarbazepine
646029|NCT02283827|E7|Reported Event|BIA 2-093 600 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
646030|NCT02283827|E6|Reported Event|Phenytoin 300 mg|Phenytoin - PHT 300 mg
646031|NCT02283827|E5|Reported Event|Phenytoin 100 mg|Phenytoin - PHT 100 mg
646032|NCT02283827|E4|Reported Event|BIA 2-093 1200 mg + Phenytoin 300 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
646033|NCT02283827|E3|Reported Event|BIA 2-093 1200 mg + Phenytoin 100 mg|Phenytoin - PHT BIA 2-093 - ESL, Eslicarbazepine
646034|NCT02283827|E2|Reported Event|BIA 2-093 1200 mg|BIA 2-093 - ESL, Eslicarbazepine
646035|NCT02283827|E1|Reported Event|BIA 2-093 600 mg|BIA 2-093 - ESL, Eslicarbazepine
646036|NCT02283814|B3|Baseline|Total|Total of all reporting groups
646037|NCT02283814|B2|Baseline|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
646038|NCT02283814|B1|Baseline|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
646039|NCT02283814|P2|Participant Flow|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
646040|NCT02283814|P1|Participant Flow|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
646041|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
646042|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
646043|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
646044|NCT02283814|O1|Outcome|BIA 2-093 + TPM|BIA 2-093 - ESL; Eslicarbazepine acetate TPM - Topamax
646045|NCT02283814|O2|Outcome|BIA 2-093|BIA 2-093 - ESL; Eslicarbazepine acetate
646047|NCT02283814|E2|Reported Event|Group B BIA 2-093 + Topamax|"Pre-treatment: 100 mg once daily dose of TPM administered for two consecutive days;~Pre-treatment 2: 100 mg twice daily dose of TPM administered for two consecutive days;~Treatment: 200 mg once daily dose of TPM administered for four consecutive days;~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 600 mg and TPM 200 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200mg for seventeen consecutive days~BIA 2-093~Topamax"
646048|NCT02283814|E1|Reported Event|Group A BIA 2-093 + Topamax|"Group A~Pre-treatment: 600 mg once daily dose of eslicarbazepine acetate (ESL) administered for two consecutive days;~Treatment 1: 1200 mg once daily dose of eslicarbazepine acetate (ESL) administered for six consecutive days~Treatment 2: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg for two consecutive days~Treatment 3: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 100 mg (morning) + 100mg (evening) for two consecutive days~Treatment 4: Concomitant doses of eslicarbazepine acetate (ESL) 1200 mg and TPM 200 mg for fifteen consecutive days~BIA 2-093~Topamax"
646049|NCT02283788|B5|Baseline|Total|Total of all reporting groups
646050|NCT02283788|B4|Baseline|Treatment Sequence DCBA|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
646051|NCT02283788|B3|Baseline|Treatment Sequence CADB|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
646052|NCT02283788|B2|Baseline|Treatment Sequence BDAC|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
646121|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646053|NCT02283788|B1|Baseline|Treatment Sequence ABCD|"A - BIA 2-093 1200 mg once daily × 5 days B - BIA 2-093 2400 mg once daily × 5 days C - Moxifloxacin 400 mg × 1 dose D - placebo once daily × 5 days~BIA 2-093~Moxifloxacin~Placebo"
646054|NCT02283788|P4|Participant Flow|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
646055|NCT02283788|P3|Participant Flow|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
646056|NCT02283788|P2|Participant Flow|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
646057|NCT02283788|P1|Participant Flow|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
646058|NCT02283788|O4|Outcome|Placebo|Placebo, PLC
646059|NCT02283788|O3|Outcome|Moxifloxacin 400 mg|brand names Avelox, Avalox, and Avelon
646060|NCT02283788|O2|Outcome|BIA 2-093 2400 mg|ESL, Eslicarbazepine 1200 mg
646061|NCT02283788|O1|Outcome|BIA 2-093 1200 mg|ESL, Eslicarbazepine 1200 mg
646062|NCT02283788|E4|Reported Event|Group D|Period 1 - placebo once daily × 5 days Period 2 - Moxifloxacin 400 mg × 1 dose Period 3 - BIA 2-093 2400 mg once daily × 5 days Period 4 - BIA 2-093 1200 mg once daily × 5 days
646063|NCT02283788|E3|Reported Event|Group C|Period 1 - Moxifloxacin 400 mg × 1 dose Period 2 - BIA 2-093 1200 mg once daily × 5 days Period 3 - placebo once daily × 5 days Period 4 - BIA 2-093 2400 mg once daily × 5 days
646064|NCT02283788|E2|Reported Event|Group B|Period 1 - BIA 2-093 2400 mg once daily × 5 days Period 2 - placebo once daily × 5 days Period 3 - BIA 2-093 1200 mg once daily × 5 days Period 4 - Moxifloxacin 400 mg × 1 dose
646065|NCT02283788|E1|Reported Event|Group A|Period 1 - BIA 2-093 1200 mg once daily × 5 days Period 2 - BIA 2-093 2400 mg once daily × 5 days Period 3 - Moxifloxacin 400 mg × 1 dose Period 4 - placebo once daily × 5 days
646066|NCT02282982|B1|Baseline|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646067|NCT02282982|P1|Participant Flow|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646068|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646069|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646070|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646071|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646072|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646073|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646074|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646075|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646076|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646077|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646078|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646079|NCT02282982|O1|Outcome|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646080|NCT02282982|E1|Reported Event|Infants at High-risk of Serious RSV Illness|Infants who received immunoprophylaxis during the RSV season
646081|NCT02282813|B4|Baseline|Total|Total of all reporting groups
646082|NCT02282813|B3|Baseline|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
646205|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
646083|NCT02282813|B2|Baseline|CTAP101 Capsules (Monotherapy; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
646084|NCT02282813|B1|Baseline|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
646085|NCT02282813|P3|Participant Flow|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
646086|NCT02282813|P2|Participant Flow|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
646087|NCT02282813|P1|Participant Flow|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
646088|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
654460|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
646089|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
646090|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
646091|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
646092|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
646093|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
646094|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
646095|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
646096|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
646097|NCT02282813|O3|Outcome|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
646098|NCT02282813|O2|Outcome|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
646099|NCT02282813|O1|Outcome|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects continued to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
646100|NCT02282813|E3|Reported Event|CTAP101 Caps 2 x 30 mcg Daily for 12 wk+Adjunctive|CTAP101 Capsules 2 x 30 mcg daily for up to 12 weeks. At week 12, a subset of eligible subjects (N=85) were randomized to take adjunctive therapy (calcitriol 0.25 mcg or doxercalciferol 0.5 mcg or paricalcitol 1 mcg) daily in addition to the CTAP101 capsules.
646101|NCT02282813|E2|Reported Event|CTAP101 Capsules (Not Randomized; 12 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily"
646102|NCT02282813|E1|Reported Event|CTAP101 Capsules (Not Randomized; 6 Mos Treatment)|"CTAP101 Capsules 30 or 60 mcg daily for up to 12 weeks, followed by additional weeks 13-26.~CTAP101 Capsules: At end of week 12, eligible subjects will continue to take 1 or 2 capsules (30 mcg each capsule) CTAP101 daily."
646103|NCT02282631|B3|Baseline|Total|Total of all reporting groups
646104|NCT02282631|B2|Baseline|Intervention School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw. Every trip to school reported by the parent as being active (walking/cycling) corresponds to one ticket entered into the draw. In total, one child can have up to five tickets entered into one draw."
646105|NCT02282631|B1|Baseline|Control School|School with no intervention; ongoing advice on active school travel.
646106|NCT02282631|P2|Participant Flow|Intervention Group School|School with intervention (incentive scheme)
646107|NCT02282631|P1|Participant Flow|Control Group School|School with no intervention (incentive scheme)
646206|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
646108|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646109|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646110|NCT02282631|O2|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646111|NCT02282631|O1|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646112|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
646113|NCT02282631|O1|Outcome|ATS Trips|active trips to school
646114|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
646115|NCT02282631|O1|Outcome|ATS Trips|active trips to school
646116|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
646117|NCT02282631|O1|Outcome|ATS Trips|active trips to school
646118|NCT02282631|O2|Outcome|Non-ATS Trips|non-active trips to school (e.g. car trips)
646119|NCT02282631|O1|Outcome|ATS Trips|active trips to school
646120|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646122|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646123|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646124|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646125|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646126|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646127|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646128|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646129|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646130|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646131|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646132|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646133|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646134|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646135|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646136|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646137|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646138|NCT02282631|O2|Outcome|Intervention Group School|"School where the incentive scheme will be run.~Incentive scheme: Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent."
646139|NCT02282631|O1|Outcome|Control Group School|School with no intervention; ongoing advice on active school travel.
646140|NCT02282631|O1|Outcome|Schools Who Took Part|Schools who took part in this study (two)
646141|NCT02282631|O1|Outcome|Schools Contacted|Primary schools (or equivalent) located in the North East approached in this study
646142|NCT02282631|E2|Reported Event|Intervention Group School|School with intervention (incentive scheme)
646143|NCT02282631|E1|Reported Event|Control Group School|School with no intervention (incentive scheme)
646144|NCT02282605|B4|Baseline|Total|Total of all reporting groups
646145|NCT02282605|B3|Baseline|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646146|NCT02282605|B2|Baseline|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646147|NCT02282605|B1|Baseline|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646148|NCT02282605|P3|Participant Flow|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646149|NCT02282605|P2|Participant Flow|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646150|NCT02282605|P1|Participant Flow|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646151|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646173|NCT02282527|P1|Participant Flow|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
646152|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646153|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646154|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646155|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646156|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646157|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646158|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646159|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646160|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646161|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646162|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646163|NCT02282605|O3|Outcome|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646164|NCT02282605|O2|Outcome|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646165|NCT02282605|O1|Outcome|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646166|NCT02282605|E3|Reported Event|Placebo Nasal Gel|"0.3mL nasal gel will be applied to each naris twice daily for two days. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~Placebo nasal gel~Chlorhexidine gluconate 2% topical cloths"
646207|NCT02281591|E4|Reported Event|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
646167|NCT02282605|E2|Reported Event|XF-73 0.5 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.15mg XF-73 per naris/0.3mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646168|NCT02282605|E1|Reported Event|XF-73 2.0 mg/g Nasal Gel|"0.3mL (nominal 300 microgram) XF-73 nasal gel will be applied to each naris, twice daily for two days. Each dose will be 0.3mL per naris/0.6mL per dose delivering 0.6mg XF-73 per naris/1.2mg XF-73 per dose. Prior to each morning dose, subjects will use chlorhexidine gluconate 2% body and face cloths.~XF-73 nasal gel~Chlorhexidine gluconate 2% topical cloths"
646169|NCT02282527|B3|Baseline|Total|Total of all reporting groups
646170|NCT02282527|B2|Baseline|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
646171|NCT02282527|B1|Baseline|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
646172|NCT02282527|P2|Participant Flow|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
646174|NCT02282527|O2|Outcome|Prolastin-C/Liquid Alpha₁-PI|"Subjects were treated first with Prolastin-C and then treated with Liquid Alpha₁-PI~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
646175|NCT02282527|O1|Outcome|Liquid Alpha₁-PI/Prolastin-C|"Subjects were treated first with Liquid Alpha₁-PI and then treated with Prolastin-C~Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
646176|NCT02282527|O2|Outcome|Prolastin-C|"Subjects treated with Prolastin-C in each treatment sequence~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
646177|NCT02282527|O1|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence~Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions"
646178|NCT02282527|O2|Outcome|Prolastin-C|"Subjects treated with Prolastin-C in each treatment sequence~Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions"
646179|NCT02282527|O1|Outcome|Liquid Alpha₁-PI|"Subjects treated with Liquid Alpha₁-PI in each treatment sequence~Liquid Alpha₁-PI: Liquid Alpha1-PI, 60 mg/kg, 8 weekly intravenous infusions"
646180|NCT02282527|E2|Reported Event|Prolastin-C|Prolastin-C: Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
646181|NCT02282527|E1|Reported Event|Liquid Alpha₁-PI|Liquid Alpha₁-PI: Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
646182|NCT02281591|B5|Baseline|Total|Total of all reporting groups
646183|NCT02281591|B4|Baseline|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
646184|NCT02281591|B3|Baseline|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
646185|NCT02281591|B2|Baseline|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
646186|NCT02281591|B1|Baseline|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
646187|NCT02281591|P4|Participant Flow|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
646188|NCT02281591|P3|Participant Flow|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
646189|NCT02281591|P2|Participant Flow|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
646190|NCT02281591|P1|Participant Flow|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
646191|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
646192|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
646193|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
646194|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
646195|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
646196|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
646197|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
646198|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
646199|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
646200|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
646201|NCT02281591|O2|Outcome|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
646202|NCT02281591|O1|Outcome|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
646203|NCT02281591|O4|Outcome|R-licarbazepine|"450 mg of Rlicarbazepine~R-licarbazepine: capsules containing 225 mg"
646204|NCT02281591|O3|Outcome|S-licarbazepine|"450 mg of S-licarbazepine~S-licarbazepine: capsules containing 225 mg"
646209|NCT02281591|E2|Reported Event|S-licarbazepine R-licarbazepine|"450 mg of S-licarbazepine plus 450 mg of R-licarbazepine~S-licarbazepine: capsules containing 225 mg~R-licarbazepine: capsules containing 225 mg"
646210|NCT02281591|E1|Reported Event|Eslicarbazepine Acetate|"900mg of eslicarbazepine acetate (ESL, BIA 2-093)~BIA 2-093: Tablets containing 900 mg"
646211|NCT02281526|B3|Baseline|Total|Total of all reporting groups
646212|NCT02281526|B2|Baseline|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646213|NCT02281526|B1|Baseline|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646214|NCT02281526|P2|Participant Flow|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646215|NCT02281526|P1|Participant Flow|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646216|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646217|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646218|NCT02281526|O2|Outcome|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
648651|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
646219|NCT02281526|O1|Outcome|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646220|NCT02281526|E2|Reported Event|Subjects - Healthy Controls|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646221|NCT02281526|E1|Reported Event|Subjects With Moderate Hepatic Impairment|"This was an open-label, multiple-dose, single-centre study in 2 groups of subjects: subjects with moderate hepatic impairment and healthy controls~BIA 2-093"
646222|NCT02281448|B3|Baseline|Total|Total of all reporting groups
646223|NCT02281448|B2|Baseline|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
646224|NCT02281448|B1|Baseline|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
646225|NCT02281448|P2|Participant Flow|Treatment Sequence B|"oral single-dose of a contraceptive for 3 days after pre-treatment with an oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days~BIA 2-093~Contraceptives, Oral, Combined"
646226|NCT02281448|P1|Participant Flow|Treatment Sequence A|"oral once daily dose of 1200 mg of BIA 2-093 plus single-dose of a contraceptive for 15 days followed by washout and 3 days of oral single-dose contraceptive~BIA 2-093~Contraceptives, Oral, Combined"
646227|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
646228|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
646229|NCT02281448|O1|Outcome|Overall Population|Overall population - 17 subjects
646230|NCT02281448|O1|Outcome|Cmax (BIA 2-194)|Mean trough (pre-dose) plasma concentrations of BIA 2-194 on Days 1, 2, 4, 6, 8, 10, 12, 14 and 15 during a 15-day oral regimen of BIA 2-093 1200 mg once-daily.
646231|NCT02281448|E2|Reported Event|Microginon®|Microginon® (n=18)
646232|NCT02281448|E1|Reported Event|Eslicarbazepine Acetate 1200 mg + Microginon®|Eslicarbazepine acetate 1200 mg + Microginon® (n=19)
646233|NCT02281422|B6|Baseline|Total|Total of all reporting groups
646234|NCT02281422|B5|Baseline|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
646235|NCT02281422|B4|Baseline|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
646236|NCT02281422|B3|Baseline|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
646237|NCT02281422|B2|Baseline|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
646238|NCT02281422|B1|Baseline|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
646239|NCT02281422|P5|Participant Flow|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
646240|NCT02281422|P4|Participant Flow|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
646241|NCT02281422|P3|Participant Flow|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
646242|NCT02281422|P2|Participant Flow|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
646243|NCT02281422|P1|Participant Flow|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
646244|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
646245|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
646246|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
646247|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
646248|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
646249|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
646250|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
646251|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
646252|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
646253|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
646254|NCT02281422|O5|Outcome|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
646255|NCT02281422|O4|Outcome|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
646256|NCT02281422|O3|Outcome|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
646257|NCT02281422|O2|Outcome|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
646258|NCT02281422|O1|Outcome|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
646259|NCT02281422|E5|Reported Event|Group 5 End Stage Renal Disease|"end stage renal disease, requiring haemodialysis (ESRD)~BIA 2-093"
646260|NCT02281422|E4|Reported Event|Group 4 Severe Renal Impairment|"severe renal impairment (creatinine clearance <30 mL/min)~BIA 2-093"
646261|NCT02281422|E3|Reported Event|Group 3 Moderate Renal Impairment|"moderate renal impairment (creatinine clearance 30-50 mL/min)~BIA 2-093"
646262|NCT02281422|E2|Reported Event|Group 2 Mild Renal Impairment|"mild renal impairment (creatinine clearance 50-80 mL/min)~BIA 2-093"
646263|NCT02281422|E1|Reported Event|Group 1 Normal Renal Function|"normal renal function (creatinine clearance > 80 mL/min)~BIA 2-093"
646264|NCT02281318|B3|Baseline|Total|Total of all reporting groups
646329|NCT02280473|B2|Baseline|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
648652|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
646265|NCT02281318|B2|Baseline|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646266|NCT02281318|B1|Baseline|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646267|NCT02281318|P2|Participant Flow|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646268|NCT02281318|P1|Participant Flow|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646269|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646270|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646271|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646272|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646273|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646274|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646275|NCT02281318|O2|Outcome|Mepolizumab 100 mg|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646276|NCT02281318|O1|Outcome|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646277|NCT02281318|E2|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646278|NCT02281318|E1|Reported Event|Placebo|Participants received placebo subcutaneously in upper arm or thigh following randomization at Visit 2 (Week 0) and every 4 weeks thereafter (last dose at Week 20) along with their standard of care asthma treatment up to 24 weeks.
646279|NCT02281136|B1|Baseline|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646280|NCT02281136|P1|Participant Flow|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646281|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646282|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646283|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646284|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646285|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646286|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646330|NCT02280473|B1|Baseline|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646331|NCT02280473|P2|Participant Flow|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646287|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646288|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646289|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646290|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646291|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646292|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646293|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646294|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646295|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646296|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646297|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646298|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646299|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646300|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646301|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646391|NCT02279667|E3|Reported Event|BIA 2-093 One 800 mg Tablet|BIA 2-093, ESL, Eslicarbazepine acetate 800 mg tablet
646302|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646303|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646304|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646305|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646306|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646307|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646308|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646309|NCT02281136|O1|Outcome|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646310|NCT02281136|E1|Reported Event|Levulan Kerastick|"20% aminolevulinic acid applied via Kerastick to individual AK lesions on the upper extremities and covered with occlusive dressing for 3 hours prior to BLU-U treatment~Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U: 10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2"
646311|NCT02280655|B3|Baseline|Total|Total of all reporting groups
646312|NCT02280655|B2|Baseline|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
646313|NCT02280655|B1|Baseline|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
646314|NCT02280655|P2|Participant Flow|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
646315|NCT02280655|P1|Participant Flow|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
646316|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
646317|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
646318|NCT02280655|O2|Outcome|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
646319|NCT02280655|O1|Outcome|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
646320|NCT02280655|E2|Reported Event|Fresh Red Blood Cells (RBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with fresh red blood cells (RBCs) units. The units had been stored for less than 14 days.~Fresh red blood cells units: Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)"
646321|NCT02280655|E1|Reported Event|Storage-aged Red Blood Cells (saRBCs)|"Subjects with cardiovascular disease (CVD) received a transfusion with older stored red blood cells (RBCs) units. The units had been stored for greater than 21 days.~Storage-aged red blood cells (saRBCs) units: Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)"
646392|NCT02279667|E2|Reported Event|BIA 2-093 - Four 200 mg Tablets|BIA 2-093, ESL, Eslicarbazepine acetate 200 mg tablets
646322|NCT02280499|B1|Baseline|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
646323|NCT02280499|P1|Participant Flow|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
646324|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
646325|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
646326|NCT02280499|O1|Outcome|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
646327|NCT02280499|E1|Reported Event|Promos™ Standard Shoulder System|All participating subjects underwent primary total shoulder arthroplasty after signing informed consent. All subjects received the Promos™ Standard shoulder system.
646328|NCT02280473|B3|Baseline|Total|Total of all reporting groups
646332|NCT02280473|P1|Participant Flow|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646333|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646334|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646335|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646336|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646337|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646338|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646339|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646340|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646341|NCT02280473|O2|Outcome|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646342|NCT02280473|O1|Outcome|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646343|NCT02280473|E2|Reported Event|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646344|NCT02280473|E1|Reported Event|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
646345|NCT02280187|B1|Baseline|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646346|NCT02280187|P1|Participant Flow|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646347|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646348|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646349|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646350|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646351|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646352|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646353|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646354|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646389|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
646390|NCT02279667|E4|Reported Event|Follow-up|Follow-up.
646355|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646356|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646357|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646358|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646359|NCT02280187|O1|Outcome|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646360|NCT02280187|E1|Reported Event|Spine Fusion With InductOs|"Patient has had spinal fusion surgery with InductOs between 1st January 2011 and 31st December 2012~Spine Fusion: All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center."
646361|NCT02280122|B3|Baseline|Total|Total of all reporting groups
646362|NCT02280122|B2|Baseline|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646363|NCT02280122|B1|Baseline|Generalised Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646364|NCT02280122|P3|Participant Flow|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646365|NCT02280122|P2|Participant Flow|Severe Chronic Periodontitis|"Sites with probing PPD ≥ 3.5 mm~PAL-V ≥ 5 mm > 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646366|NCT02280122|P1|Participant Flow|Moderate Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646367|NCT02280122|O2|Outcome|Specificity: Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646368|NCT02280122|O1|Outcome|Sensitivity: Generalised Moderate/Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) ≥ 3 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646369|NCT02280122|E2|Reported Event|Periodontally Healthy|"PPD ≤ 3 mm~PAL-V ≤ 2 mm at < 30% of sites~BOP < 20%~No radiographically detectable bone loss: distance cemento-enamel junction to provided~no Intervention but aMMP-8 test~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646370|NCT02280122|E1|Reported Event|Generalized Moderate to Severe Chronic Periodontitis|"Sites with probing pocket depths (PPD) ≥ 3.5 mm~Attachment loss (PAL-V) 3-4 mm > 30% of sites, PAL-V ≥ 5 mm ≤ 30% of sites~no Intervention provided~no intervention provided: No Intervention was rendered but the aMMP-8 test was made"
646371|NCT02279667|B4|Baseline|Total|Total of all reporting groups
646372|NCT02279667|B3|Baseline|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
646373|NCT02279667|B2|Baseline|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
646374|NCT02279667|B1|Baseline|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
646375|NCT02279667|P3|Participant Flow|Group C|"st period - Four 200 mg tablets~nd period - One 800 mg tablet~rd period - 16 mL oral suspension 50 mg/mL"
646376|NCT02279667|P2|Participant Flow|Group B|"st period - One 800 mg tablet~nd period - 16 mL oral suspension 50 mg/mL~rd period - Four 200 mg tablets"
646377|NCT02279667|P1|Participant Flow|Group A|"st period - 16 mL oral suspension 50 mg/mL~nd period - Four 200 mg tablets~rd period - One 800 mg tablet"
646378|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
646379|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
646380|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
646381|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
646382|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
646383|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
646384|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
646385|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
646386|NCT02279667|O1|Outcome|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093 (ESL, Eslicarbazepine acetate) 16 mL oral suspension 50 mg/mL
646387|NCT02279667|O3|Outcome|BIA 2-093 One 800 mg Tablet|BIA 2-093 (ESL, Eslicarbazepine acetate) - One 800 mg tablet
646388|NCT02279667|O2|Outcome|BIA 2-093 - Four 200 mg Tablets|BIA 2-093 (ESL, Eslicarbazepine acetate) - Four 200 mg tablets
646393|NCT02279667|E1|Reported Event|BIA 2-093 16 mL Oral Suspension 50 mg/mL|BIA 2-093, ESL, Eslicarbazepine acetate oral suspension 50 mg/mL
646394|NCT02279420|B1|Baseline|Essential Study Sham Cross-over|Device: g-Cath EZ™ Suture Anchor Delivery Catheter This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
646395|NCT02279420|P1|Participant Flow|Essential Study Sham Cross-over|Eligible sham subjects from primary study
646396|NCT02279420|O1|Outcome|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
646442|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
646443|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
646444|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation Using XprESS and PathAssist Devices.
646397|NCT02279420|E1|Reported Event|Essential Study Sham Cross-over|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
646398|NCT02279407|B5|Baseline|Total|Total of all reporting groups
646399|NCT02279407|B4|Baseline|Placebo|Placebo to Epanova and placebo to Dapagliflozin
646400|NCT02279407|B3|Baseline|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
646401|NCT02279407|B2|Baseline|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
646402|NCT02279407|B1|Baseline|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
646403|NCT02279407|P4|Participant Flow|Placebo|Placebo to Epanova and placebo to Dapagliflozin
646404|NCT02279407|P3|Participant Flow|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
646405|NCT02279407|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
646406|NCT02279407|P1|Participant Flow|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
646407|NCT02279407|O3|Outcome|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
646408|NCT02279407|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
646409|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
646410|NCT02279407|O2|Outcome|Placebo|Placebo to Epanova and placebo to Dapagliflozin
646411|NCT02279407|O1|Outcome|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
646412|NCT02279407|E4|Reported Event|Placebo|Placebo to Epanova and placebo to Dapagliflozin
646413|NCT02279407|E3|Reported Event|Dapagliflozin|Dapagliflozin 10 mg/day + placebo to Epanova
646414|NCT02279407|E2|Reported Event|Epanova|Epanova 4 g/day + placebo to Dapagliflozin
646415|NCT02279407|E1|Reported Event|Epanova + Dapagliflozin|Epanova 4 g/day + Dapagliflozin 10 mg/day
646416|NCT02278783|B1|Baseline|All Patients|
646417|NCT02278783|P1|Participant Flow|All Patients|
646418|NCT02278783|O1|Outcome|All Patients|
646419|NCT02278783|O1|Outcome|All Patients|
646420|NCT02278783|O1|Outcome|All Patients|
646421|NCT02278783|O1|Outcome|All Patients|
646422|NCT02278783|E1|Reported Event|All Patients|
646423|NCT02278640|B1|Baseline|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
646424|NCT02278640|P1|Participant Flow|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
646425|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
646426|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
646427|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
646428|NCT02278640|O1|Outcome|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
646429|NCT02278640|E1|Reported Event|Harmonic ACE®+7 Shears|"Single Arm study using Harmonic ACE for dissection and transection in Hysterectomy~Harmonic ACE®+7 Shears: Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature."
646430|NCT02278614|B3|Baseline|Total|Total of all reporting groups
646431|NCT02278614|B2|Baseline|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
646432|NCT02278614|B1|Baseline|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
646433|NCT02278614|P2|Participant Flow|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
646658|NCT02275611|P4|Participant Flow|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
646434|NCT02278614|P1|Participant Flow|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
646435|NCT02278614|O2|Outcome|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
646436|NCT02278614|O1|Outcome|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
646437|NCT02278614|E2|Reported Event|Xalacom|"Xalacom®: Latanoprost 0.005% + Timolol 0.5% preserved eye drops~Xalacom: Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container."
646438|NCT02278614|E1|Reported Event|T2347|"T2347: fixed combination Latanoprost 0.005% + Timolol 0.5% unpreserved eye drops~T2347: T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers."
646439|NCT02278484|B1|Baseline|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
646440|NCT02278484|P1|Participant Flow|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
646441|NCT02278484|O1|Outcome|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
646445|NCT02278484|E1|Reported Event|Balloon Sinus Dilation|Balloon Sinus Dilation using XprESS and PathAssist Devices.
646446|NCT02278146|B3|Baseline|Total|Total of all reporting groups
646447|NCT02278146|B2|Baseline|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646448|NCT02278146|B1|Baseline|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646449|NCT02278146|P2|Participant Flow|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646450|NCT02278146|P1|Participant Flow|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646451|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646452|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646453|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646454|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646455|NCT02278146|O2|Outcome|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646456|NCT02278146|O1|Outcome|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646457|NCT02278146|E2|Reported Event|2) Overactive Bladder|"Overactive bladder. Diagnosed with overactive bladder syndrome and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646458|NCT02278146|E1|Reported Event|1) Stress Urinary Incontinence|"Stress urinary incontinence. Diagnosed with urinary stress incontinence and treated with the ParaPatch System~ParaPatch: A device for the treatment of urinary incontinence"
646459|NCT02277626|B1|Baseline|Total Number of Participants|
646460|NCT02277626|P2|Participant Flow|ElectroFlo First Then Vest|"Experimental: ElectroFlo 5000, then VEST 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of ElectroFlo 5000 at one visit and during the second visit, they crossed-over to the Vest.~Electro Flo 5000: Airway clearance device"
646461|NCT02277626|P1|Participant Flow|Vest First Then ElectroFlo|"Experimental: VEST, then ElectroFlo 5000 15 Patients were recruited from the Cystic Fibrosis Program at Stanford. All 15 patients were randomized to a sequence of Vest at one visit and during the second visit, they crossed-over to the ElectroFlo 5000.~EnCourage Vest System: Airway Clearance Device"
646462|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
646463|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~EnCourage Vest System: Airway Clearance Device"
646464|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
646465|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~EnCourage Vest System: Airway Clearance Device"
646466|NCT02277626|O2|Outcome|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
646467|NCT02277626|O1|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
646468|NCT02277626|O2|Outcome|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
646469|NCT02277626|O1|Outcome|Vest Arm|"Vest Arm~Incourage Vest System: Airway Clearance Device"
646470|NCT02277626|O2|Outcome|Elecflo Arm|"Elecflo Arm~Electro Flo 5000: Airway clearance device"
646471|NCT02277626|O1|Outcome|Vest|"VEST Arm~Incourage Vest System: Airway Clearance Device"
646472|NCT02277626|E2|Reported Event|ElectroFlo Arm|"ElectroFlo Arm~Electro Flo 5000: Airway clearance device"
646473|NCT02277626|E1|Reported Event|Vest Arm|"Vest arm~Incourage Vest System: Airway Clearance Device"
646474|NCT02277249|B3|Baseline|Total|Total of all reporting groups
646807|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
646475|NCT02277249|B2|Baseline|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646476|NCT02277249|B1|Baseline|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646477|NCT02277249|P2|Participant Flow|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646478|NCT02277249|P1|Participant Flow|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646669|NCT02275611|E3|Reported Event|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
646479|NCT02277249|O2|Outcome|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646480|NCT02277249|O1|Outcome|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646481|NCT02277249|E2|Reported Event|Transabdominal Digoxin|"Transabdominal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transabdominal administration): Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646482|NCT02277249|E1|Reported Event|Transvaginal Digoxin|"Transvaginal administration of digoxin for inducing fetal death prior to second-trimester abortion~Digoxin (transvaginal administration): Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
646483|NCT02277119|B4|Baseline|Total|Total of all reporting groups
646484|NCT02277119|B3|Baseline|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646485|NCT02277119|B2|Baseline|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646486|NCT02277119|B1|Baseline|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646487|NCT02277119|P3|Participant Flow|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646488|NCT02277119|P2|Participant Flow|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646489|NCT02277119|P1|Participant Flow|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646490|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646491|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646492|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646493|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646494|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646495|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646496|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646497|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646498|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
648377|NCT02252744|O1|Outcome|RA Patients|Adult patients diagnosed with rheumatoid arthritis
646499|NCT02277119|O3|Outcome|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646500|NCT02277119|O2|Outcome|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646501|NCT02277119|O1|Outcome|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646502|NCT02277119|E3|Reported Event|Eyes With Retinal Diseases|"Subjects presenting with Retinal pathological eyes will be scanned on the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646503|NCT02277119|E2|Reported Event|Glaucomatous Eyes|"Subjects presenting with different stages of glaucoma will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646504|NCT02277119|E1|Reported Event|Normal Eyes|"Subjects with no known ocular diseases will be scanned with the iVue and Maestro device~Maestro: OCT machines used for diagnostic purposes~iVue: OCT machines used for diagnostic purposes"
646559|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646505|NCT02277093|B1|Baseline|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646506|NCT02277093|P1|Participant Flow|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646507|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646508|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646509|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646510|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646511|NCT02277093|O1|Outcome|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646512|NCT02277093|E1|Reported Event|Pacritinib|"Pacritinib is an oral drug which will be taken on an outpatient basis daily on a 28-day cycle at a dose of 200 mg twice a day (BID)~Pacritinib should be take at approximately the same times every day with a glass of water, with or without food"
646513|NCT02276560|B4|Baseline|Total|Total of all reporting groups
646514|NCT02276560|B3|Baseline|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
646515|NCT02276560|B2|Baseline|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
646516|NCT02276560|B1|Baseline|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
646517|NCT02276560|P3|Participant Flow|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
646518|NCT02276560|P2|Participant Flow|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
646519|NCT02276560|P1|Participant Flow|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
646520|NCT02276560|O3|Outcome|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
646521|NCT02276560|O2|Outcome|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
646522|NCT02276560|O1|Outcome|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
646523|NCT02276560|E3|Reported Event|Cisplatin+Pemetrexed or Gemcitabine|"Adjuvant cisplatin (75mg/m2) D1, pemetrexed (500mgm2) D1 or; cisplatin (75 mg/m2),Gemcitabine (1000mg/m2) D1, 8 repeat each 21D cycle x 4~Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine: Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4"
653879|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
646524|NCT02276560|E2|Reported Event|Adjuvant Cisplatin,Nab-paclitaxel|"Adjuvant cisplatin (75mg/m2) D1, nab-paclitaxel (125 mg/m2)for D1, 8, 15 repeat each 28D x 2~Adjuvant Cisplatin,nab-paclitaxel: Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2"
646525|NCT02276560|E1|Reported Event|Neoadjuvant Cisplatin,Nab-paclitaxel|"Neoadjuvant cisplatin (75 mg/m2) D1 and nab-paclitaxel (125 mg/m2) D1, 8, 15, repeat each 28D cycle x 3 and then surgery per standard of care~Neoadjuvant Cisplatin, nab-paclitaxel: Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery"
646526|NCT02276274|B3|Baseline|Total|Total of all reporting groups
646527|NCT02276274|B2|Baseline|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
646560|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646817|NCT02273908|E1|Reported Event|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care No intervention: The study is observational
646528|NCT02276274|B1|Baseline|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
646529|NCT02276274|P2|Participant Flow|SYR-322-MET Fed Followed by SYR-322-MET Fasted|A single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of second intervention period.
646530|NCT02276274|P1|Participant Flow|SYR-322-MET Fasted Followed by SYR-322-MET Fed|A single dose of SYR-322 25 milligram (mg) and metformin hydrochloride 500 mg in 1 tablet, orally under fasted condition on Day 1 of first intervention period, followed by at least 15 days of washout period, followed by a single dose of SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally under fed condition on Day 1 of second intervention period.
646531|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646532|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646533|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646534|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646535|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646536|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646537|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646538|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646539|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646540|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646541|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646542|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646543|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646544|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646545|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646546|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646547|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646548|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646549|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646550|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646551|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646552|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646553|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646659|NCT02275611|P3|Participant Flow|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
646554|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646555|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646556|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646557|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646558|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646668|NCT02275611|E4|Reported Event|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
646561|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646562|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646563|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646564|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646565|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646566|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646567|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646568|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646569|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646570|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646571|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646572|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646573|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646574|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646575|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646576|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646577|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646578|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646579|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646580|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646581|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646582|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646583|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646584|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646585|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646586|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646587|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646588|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646808|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646589|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646590|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646591|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646592|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646593|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646594|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646595|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646596|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646597|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646598|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646599|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646600|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646601|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646602|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646603|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646604|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646605|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646606|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646607|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646608|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646609|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646610|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646611|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646612|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646613|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646614|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646615|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646616|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646617|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646618|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646619|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646620|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646621|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646622|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646623|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646809|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
646624|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646625|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646626|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646627|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646628|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646629|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646630|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646631|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646632|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646633|NCT02276274|O2|Outcome|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646634|NCT02276274|O1|Outcome|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646635|NCT02276274|E2|Reported Event|SYR-322-MET Fed|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fed condition on Day 1 of either first or second intervention period.
646636|NCT02276274|E1|Reported Event|SYR-322-MET Fasted|SYR-322 25 mg and metformin hydrochloride 500 mg in 1 tablet, orally, under fasted condition on Day 1 of either first or second intervention period.
646637|NCT02275767|B4|Baseline|Total|Total of all reporting groups
646638|NCT02275767|B3|Baseline|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
646639|NCT02275767|B2|Baseline|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
646640|NCT02275767|B1|Baseline|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
646641|NCT02275767|P3|Participant Flow|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
646642|NCT02275767|P2|Participant Flow|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
646643|NCT02275767|P1|Participant Flow|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
646644|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
646645|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
646646|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
646647|NCT02275767|O3|Outcome|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
646648|NCT02275767|O2|Outcome|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
646649|NCT02275767|O1|Outcome|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
646650|NCT02275767|E3|Reported Event|100% Cancellous FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cancellous FDBA: Ridge preservation after tooth extraction using 100% cancellous FDBA"
646651|NCT02275767|E2|Reported Event|100% Cortical FDBA|"Ridge preservation with 100% cortical freeze-dried bone allograft (FDBA)~100% cortical FDBA: Ridge preservation after tooth extraction using 100% cortical FDBA"
646652|NCT02275767|E1|Reported Event|Combination 50% Cortical/50% Cancellous FDBA|"Ridge preservation with Combination 50% cortical/50% cancellous freeze-dried bone allograft (FDBA)~50% cortical/50% cancellous FDBA: Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA"
646653|NCT02275611|B5|Baseline|Total|Total of all reporting groups
646654|NCT02275611|B4|Baseline|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
646655|NCT02275611|B3|Baseline|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
646656|NCT02275611|B2|Baseline|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal placebo spray. Inpatient Withdrawal
646657|NCT02275611|B1|Baseline|Intranasal Oxytocin Spray (Syntocinon)|Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks intranasal oxytocin spray. Inpatient Withdrawal
646956|NCT02272725|B3|Baseline|Total|Total of all reporting groups
646660|NCT02275611|P2|Participant Flow|Placebo Comparator: Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks Inpatient Withdrawal
646661|NCT02275611|P1|Participant Flow|Active Comparator:Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks.~Inpatient Withdrawal"
646662|NCT02275611|O2|Outcome|Outpatient Treatment Placebo Spray|2 daily doses intranasal placebo spray for 12 weeks
646663|NCT02275611|O1|Outcome|Outpatient Treatment Intranasal Oxytocin Spray (Syntocinon)|2 daily doses intranasal oxytocin spray for 12 weeks
646664|NCT02275611|O2|Outcome|Intranasal Placebo Spray|Placebo spray 3-4 doses daily inpatient
646665|NCT02275611|O1|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|Syntocinon Spray 3-4 doses daily inpatient
646666|NCT02275611|O2|Outcome|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient~intranasal oxytocin spray: Administration of oxytocin in a nasal spray~Intranasal Placebo Spray: Intranasal Placebo Spray"
646667|NCT02275611|O1|Outcome|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient~intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
654461|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
646670|NCT02275611|E2|Reported Event|Intranasal Placebo Spray|"Placebo spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks~intranasal oxytocin spray: Administration of oxytocin in a nasal spray~Intranasal Placebo Spray: Intranasal Placebo Spray"
646671|NCT02275611|E1|Reported Event|Intranasal Oxytocin Spray (Syntocinon Spray)|"Syntocinon Spray 3-4 doses daily inpatient; 2 daily doses outpatient for 12 weeks~intranasal oxytocin spray: Administration of oxytocin in a nasal spray"
646672|NCT02275546|B1|Baseline|All Randomized Participants|
646673|NCT02275546|P2|Participant Flow|No Applicator (Manual)→Applicator|In Treatment Period 1, participants manually inserted the vaginal ring using their fingers only. In Treatment Period 2, participants used the applicator to insert the vaginal ring.
646674|NCT02275546|P1|Participant Flow|Applicator→No Applicator (Manual)|In Treatment Period 1, participants used the applicator to insert the vaginal ring. In Treatment Period 2 participants manually inserted the vaginal ring using their fingers only.
646675|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
646676|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
646677|NCT02275546|O2|Outcome|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
646678|NCT02275546|O1|Outcome|Applicator|Participants used the applicator to insert the vaginal ring.
646679|NCT02275546|E2|Reported Event|No Applicator (Manual)|Participants manually inserted the vaginal ring using their fingers only.
646680|NCT02275546|E1|Reported Event|Applicator|Participants used the applicator to insert the vaginal ring.
646681|NCT02275364|B1|Baseline|Overall|Participants were randomized to receive either Marketed Nasal Strip or Placebo Nasal Strip (to be applied for up to two hours in either of the first two scans only). During the third scanning session, Marketed Nasal Strip was applied for approximately 20 minutes after administration of a Marketed Decongestant.
646682|NCT02275364|P2|Participant Flow|Sequence 2|In the sequence 1 of the crossover part of the study, participants were randomized to receive marketed strip first (period 1) followed by marketed strip (period 2). The marketed strip was applied for up to two hours for the first scanning sessions, and then removed and the placebo strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
646683|NCT02275364|P1|Participant Flow|Sequence 1|In the sequence 1 of the crossover part of the study, participants were randomized to receive placebo strip first (period 1) followed by marketed strip (period 2). The placebo strip was applied for up to two hours for the first scanning sessions, and then removed and the marketed strip applied for the second scanning session. The strip was removed and participants applied the nasal spray (period 3) and then after approximately 30 minutes, applied the marketed nasal strip for the third scanning session (period 4). There was no washout for period 3, as treatment B i.e. marketed nasal strip, was added in period 4 to the nasal decongestant spray that was applied in period 3
646684|NCT02275364|O1|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
646685|NCT02275364|O2|Outcome|Placebo Strip|Placebo nasal strip to be applied for up to two hours in either of the first two scans only.
646686|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646687|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646688|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646689|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646690|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646691|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
646692|NCT02275364|O3|Outcome|Decongestant|A marketed nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
646693|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646694|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646695|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646696|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646697|NCT02275364|O4|Outcome|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
646698|NCT02275364|O3|Outcome|Decongestant|A nasal decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
646699|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646700|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646701|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646702|NCT02275364|O1|Outcome|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646703|NCT02275364|O4|Outcome|Test Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
646704|NCT02275364|O3|Outcome|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
646705|NCT02275364|O2|Outcome|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646706|NCT02275364|O1|Outcome|Test Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, in either of the first two sessions
646707|NCT02275364|E4|Reported Event|Marketed Nasal Strip Plus Decongestant|Marketed Nasal Strip to be applied during the third scanning session for approximately 20 minutes, after administration of a Marketed Decongestant.
646708|NCT02275364|E3|Reported Event|Decongestant|A Nasal Decongestant was administered (one spray per nostril) by the participants 20 mins (+/- 5 mins) prior to the third MRI scanning session.
646709|NCT02275364|E2|Reported Event|Placebo Nasal Strip|Placebo Nasal Strip to be applied for up to two hours in either of the first two scans only.
646710|NCT02275364|E1|Reported Event|Marketed Nasal Strip|Marketed Nasal Strip to be applied for up to two hours, and during the third scanning session for approximately 20 minutes.
646711|NCT02275156|B4|Baseline|Total|Total of all reporting groups
646712|NCT02275156|B3|Baseline|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646713|NCT02275156|B2|Baseline|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646714|NCT02275156|B1|Baseline|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646715|NCT02275156|P3|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646716|NCT02275156|P2|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646717|NCT02275156|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646718|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646719|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646720|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646721|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646722|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646723|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646724|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646725|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646726|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646727|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646728|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646729|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646730|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646731|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646732|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646733|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646734|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646735|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646736|NCT02275156|O3|Outcome|End Stage Renal Disease|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646737|NCT02275156|O2|Outcome|Severe Renal Impairment|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
648653|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
646738|NCT02275156|O1|Outcome|Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646739|NCT02275156|E4|Reported Event|Evolocumab 140 mg - Total|Participants received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646740|NCT02275156|E3|Reported Event|Evolocumab 140 mg - ESRD Requiring Hemodialysis|Participants with end-stage renal disease (ESRD) requiring hemodialysis received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646741|NCT02275156|E2|Reported Event|Evolocumab 140 mg - Severe RI|Participants with severe renal impairment (defined as eGFR 15 to 29 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646742|NCT02275156|E1|Reported Event|Evolocumab 140 mg - Normal Renal Function|Participants with normal renal function (defined as an estimated glomerular filtration rate [eGFR] ≥ 90 mL/min/1.73 m²) received a single 140 mg dose of evolocumab subcutaneously on Day 1.
646743|NCT02275052|B1|Baseline|UMEC/VI 62.5/25 mcg and Placebo in One of the Two Sequences|Par. received a sequence consisting of the following 2 treatments: One inhalation of UMEC/VI 62.5/25 mcg or placebo once daily using a DPI. Each treatment was self-administered in the morning for 12 weeks. The treatments were separated by a 12 to 17 day washout period; all par. were provided with albuterol for use on an ‘as needed’ basis throughout the run-in, washout and study treatment periods while on investigational product.
646744|NCT02275052|P4|Participant Flow|Period 2: Placebo Then UMEC/VI 62.5/25 µg|Participants received placebo and then UMEC/VI 62.5 µg/25 µg each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
646745|NCT02275052|P3|Participant Flow|Period 2: UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/VI 62.5 µg/25 µg and then Placebo each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
646746|NCT02275052|P2|Participant Flow|UMEC/VI 62.5/25 µg Then Placebo|Participants received UMEC/ VI 62.5 µg/25 µg and then placebo each morning (once daily) as one inhalation via the DPI for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
646747|NCT02275052|P1|Participant Flow|Placebo Then UMEC/VI 62.5/25 µg|Participants received Placebo and then umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 micrograms (µg)/25 µg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) for 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
646748|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
646749|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
646750|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
646751|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
646752|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
646777|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646753|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
646754|NCT02275052|O2|Outcome|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
646755|NCT02275052|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
646865|NCT02273167|P2|Participant Flow|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
654462|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
646756|NCT02275052|E2|Reported Event|Placebo|Participants received placebo each morning (once daily) as one inhalation via the DPI in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed' basis throughout the run-in, washout and study treatment periods while on investigational product.
646757|NCT02275052|E1|Reported Event|UMEC/VI 62.5/25 mcg|Participants received umeclidinium (UMEC)/ vilanterol trifenatate (VI) 62.5 mcg/25 mcg each morning (once daily) as one inhalation via the Dry Powder Inhaler (DPI) in one of the 2 treatment periods of 12 weeks. The treatment periods were separated by a washout period of 12-17 days; all par. were provided with albuterol for use on an 'as needed (prn)' basis throughout the run-in, washout and study treatment periods while on investigational product.
646758|NCT02274948|B3|Baseline|Total|Total of all reporting groups
646759|NCT02274948|B2|Baseline|Placebo|"173 were randomized to receive placebo~Metformin and placebo were manufactured by the State Pharmaceutical Manufacturing Corporation, Sri Lanka and both tablets look similar except for the active pharmacological compound in one"
646760|NCT02274948|B1|Baseline|Metformin|"166 were randomized to receive Metformin. After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166) and placebo (173).~Children, 8 to 10.99 years received metformin 250mg daily for a week and increased to 250mg twice daily for a week and thereafter 500 mg twice daily. Eleven to 16 year old children received 500mg of metformin daily for one week and increased to 500mg twice daily for a week and thereafter 1g twice daily. Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia"
646761|NCT02274948|P2|Participant Flow|Placebo|"A placebo tablet which is physically similar to metformin tablets will be given in a similar manner as described above (the placebo is manufactured by the same manufacturer, State Pharmaceutical Manufacturing Corporation)~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
646762|NCT02274948|P1|Participant Flow|Metformin|"8-10.99 year old children will receive metformin. Initially children will be given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children will receive 500mg of metformin daily initially for one week which will be increased to 500mg twice daily for a week and then to 1g twice daily. The medication will be continued for 12 months.~Metformin: A dummy tablet similar to Metformin will be administer to the control group"
646763|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
646764|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
646765|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
646766|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
646767|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
646768|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
646769|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
646770|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metforming (166)
646771|NCT02274948|O2|Outcome|Placebo|173 were randomized to receive placebo
646772|NCT02274948|O1|Outcome|Metformin|After a field survey 500 obese children were identified and invited to this study. 155 declined the invitation so the balance 339 were randomized to receive Metformin (166)
646773|NCT02274948|E2|Reported Event|Placebo|"The placebo group was given medication in a similar manner and the number of tablets to be taken each occasion were similar to the treatment group~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
646774|NCT02274948|E1|Reported Event|Metformin|"8-10.99 year old children received metformin. Initially children were given 250mg of metformin daily for a week and increased to 250mg twice daily for a week and then to 500 mg twice daily there after. 11-16 year old children received 500mg of metformin daily initially for one week increased to 500mg twice daily for a week and then to 1g twice daily.~Children were asked to take medication with their morning and evening meals to reduce gastro intestinal side effects and risk of hypoglycaemia. Effects to medication were evaluated before each dose revision and was monitored for all possible adverse events."
646775|NCT02274792|B1|Baseline|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646776|NCT02274792|P1|Participant Flow|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646806|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646778|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646779|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646780|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646781|NCT02274792|O1|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646782|NCT02274792|E1|Reported Event|Etanercept|Participants received etanercept 50 mg subcutaneously twice a week (BIW) for 12 weeks followed by 50 mg once a week for an additional 12 weeks.
646866|NCT02273167|P1|Participant Flow|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646867|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646783|NCT02274675|B1|Baseline|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646784|NCT02274675|P1|Participant Flow|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646785|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646786|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646787|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646788|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646789|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646790|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646791|NCT02274675|O1|Outcome|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646792|NCT02274675|E1|Reported Event|Robot Group|"Receive 0.5 hour of robot-assisted therapy for wrist and forearm and 1.5 hours of daily standard rehabilitation therapy~Robot-assisted therapy for wrist and forearm: Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.~Standard rehabilitation therapy: Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities"
646793|NCT02273908|B3|Baseline|Total|Total of all reporting groups
646794|NCT02273908|B2|Baseline|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care :no intervention
646795|NCT02273908|B1|Baseline|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care :no intervention
646796|NCT02273908|P2|Participant Flow|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
646797|NCT02273908|P1|Participant Flow|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646798|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care : No intervention
646799|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care : no intervention
646800|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646801|NCT02273908|O2|Outcome|Other Analgesics|2.Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
646802|NCT02273908|O1|Outcome|Pregabalin|1.Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646803|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
646804|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646805|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention
646810|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646811|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
646812|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646813|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
646814|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646815|NCT02273908|O2|Outcome|Other Analgesics|Patients will be treated for 8 weeks with other analgesics in usual care:no intervention.
646816|NCT02273908|O1|Outcome|Pregabalin|Patients will be treated for 8 weeks with pregabalin in primary care:no intervention
646818|NCT02273752|B1|Baseline|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646819|NCT02273752|P1|Participant Flow|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic therapeutic drug monitoring (TDM) on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646820|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646821|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646822|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646823|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646824|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646825|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646826|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646827|NCT02273752|O1|Outcome|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646868|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646869|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646870|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646828|NCT02273752|E1|Reported Event|Supportive Care (Real-time Pharmacokinetic TDM of Everolimus)|"Patients receive everolimus PO daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients also undergo real-time pharmacokinetic TDM on days 4, 8, and 15 of course 1. Dosing adjustments of everolimus will be performed on day 8, if necessary. If the everolimus dose is adjusted, patients will continue to undergo real-time pharmacokinetic TDM weekly until goal concentrations are achieved on 2 consecutive measures. Patients whose everolimus dose is not adjusted undergo real-time pharmacokinetic TDM on day 1 of courses 2-6.~Everolimus: Given PO"
646829|NCT02273323|B1|Baseline|All Study Participants|Participants who were randomised to either receive Tea first followed by Placebo or Placebo first followed by Tea
646830|NCT02273323|P2|Participant Flow|Placebo Then Tea|Subjects first received a single acute dose of placebo consisting of tea flavour, colouring and sugar. After a washout of at least 1 week, they received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar
646831|NCT02273323|P1|Participant Flow|Tea Then Placebo|Subjects first received a single acute dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. After a washout of at least 1 week, they received a single acute dose of placebo consisting of tea flavour, colouring and sugar.
646832|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
646833|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
646834|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
646835|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
646836|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
646837|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
646838|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
646839|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
646840|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
646841|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
646842|NCT02273323|O2|Outcome|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
646843|NCT02273323|O1|Outcome|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
646844|NCT02273323|E2|Reported Event|Placebo Beverage|Participants when they received a single dose of placebo containing tea flavour, colouring and sugar
646845|NCT02273323|E1|Reported Event|Tea Beverage|Participants when they received a single dose of black tea infusion with added sugar
646846|NCT02273310|B3|Baseline|Total|Total of all reporting groups
646847|NCT02273310|B2|Baseline|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
646848|NCT02273310|B1|Baseline|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
646849|NCT02273310|P2|Participant Flow|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
646850|NCT02273310|P1|Participant Flow|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
646851|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day Problem-Solving Skills training for disease management intervention~Problem-Solving Skills Training for Disease Management: Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease."
646852|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
646853|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
646854|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
646855|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
646856|NCT02273310|O2|Outcome|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
646857|NCT02273310|O1|Outcome|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
646858|NCT02273310|E2|Reported Event|Delayed Intervention Control|Families are given the opportunity to complete the problem solving skills training intervention after assessment time 2.
646859|NCT02273310|E1|Reported Event|Families Taking Control|"Families participate in a 1 day problem solving skills training intervention~Problem Solving Training for Disease Management"
646860|NCT02273167|B4|Baseline|Total|Total of all reporting groups
646957|NCT02272725|B2|Baseline|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
646861|NCT02273167|B3|Baseline|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646862|NCT02273167|B2|Baseline|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646863|NCT02273167|B1|Baseline|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646864|NCT02273167|P3|Participant Flow|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646871|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646872|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646873|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646874|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646875|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646876|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646877|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646878|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646879|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646880|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646881|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646882|NCT02273167|O3|Outcome|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646883|NCT02273167|O2|Outcome|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646884|NCT02273167|O1|Outcome|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646885|NCT02273167|E3|Reported Event|NER1006,1-Day Morning Split-Dosing|NER1006: 1-Day Morning Split-Dosing Regimen (to commence in the morning of the day of colonoscopy).
646886|NCT02273167|E2|Reported Event|NER1006, 2-Day Split-Dosing|NER1006: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646887|NCT02273167|E1|Reported Event|MOVIPREP, 2-Day Split-Dosing|MOVIPREP®: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy).
646888|NCT02273141|B3|Baseline|Total|Total of all reporting groups
646889|NCT02273141|B2|Baseline|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646890|NCT02273141|B1|Baseline|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the moring of the day before colonoscopy).
646891|NCT02273141|P2|Participant Flow|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646892|NCT02273141|P1|Participant Flow|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
646893|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646894|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
646895|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646896|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
646897|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646898|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
646899|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646900|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
646901|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646902|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
648378|NCT02252744|E1|Reported Event|RA Patients|Adult patients diagnosed with rheumatoid arthritis
646903|NCT02273141|O2|Outcome|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646904|NCT02273141|O1|Outcome|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
646905|NCT02273141|E2|Reported Event|NER1006, Day Before-Only Dosing|NER1006 1-Day Day Before-Only Split-Dosing Regimen (to commence on the evening of the day before colonoscopy).
646906|NCT02273141|E1|Reported Event|SP+MS, Day Before-Only Dosing|SP+MS 1-Day Day Before-Only Split-Dosing Regimen (to commence on the morning of the day before colonoscopy).
646907|NCT02273115|B5|Baseline|Total|Total of all reporting groups
646908|NCT02273115|B4|Baseline|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646971|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
646909|NCT02273115|B3|Baseline|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646910|NCT02273115|B2|Baseline|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646911|NCT02273115|B1|Baseline|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646912|NCT02273115|P4|Participant Flow|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646913|NCT02273115|P3|Participant Flow|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646914|NCT02273115|P2|Participant Flow|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646915|NCT02273115|P1|Participant Flow|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646958|NCT02272725|B1|Baseline|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
646959|NCT02272725|P2|Participant Flow|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
646960|NCT02272725|P1|Participant Flow|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
646961|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
646916|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646917|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
648654|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
646918|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646919|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646920|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646921|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646922|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646923|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646924|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646925|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646926|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646927|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646928|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646929|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646930|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646931|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646932|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646933|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646934|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646935|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646936|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646937|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646938|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646939|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646940|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646941|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646942|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646943|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646944|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646945|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646946|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646947|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646948|NCT02273115|O4|Outcome|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646949|NCT02273115|O3|Outcome|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646950|NCT02273115|O2|Outcome|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646951|NCT02273115|O1|Outcome|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646952|NCT02273115|E4|Reported Event|Multi(Primi)Parous - Foley and Oxytocin|"Multiparous and primiparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646953|NCT02273115|E3|Reported Event|Multi(Primi)Parous - Foley Only|"Multiparous and primiparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646954|NCT02273115|E2|Reported Event|Nulliparous - Foley and Oxytocin|"Nulliparous women randomized to receive Foley and oxytocin treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol immediately after Foley placement.~Oxytocin~Transcervical Foley catheter"
646955|NCT02273115|E1|Reported Event|Nulliparous - Foley Only|"Nulliparous women randomized to receive Foley only treatment will have a 20 French latex or silicone Foley catheter placed by the provider in the method they are most comfortable (direct visualization or indirectly). Balloons will have the ability to accommodate up to 80 ml of fluid to avoid rupture. The Foley balloon with be instilled with 60 ml of saline. The end of the catheter is then taped to the medial aspect of the patient’s thigh on tension. No additional ripening agents or oxytocin will be administered while the Foley is in place. If spontaneous expulsion has not occurred, the Foley will be removed after 12 hours. Oxytocin will be administered per Christiana Care protocol after Foley removal.~Transcervical Foley catheter"
646962|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
646963|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
646964|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
646965|NCT02272725|O2|Outcome|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
646966|NCT02272725|O1|Outcome|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
646967|NCT02272725|E2|Reported Event|Ibuprofen|"Each tablet containing 400mg of ibuprofen~Ibuprofen: Ibuprofen"
646968|NCT02272725|E1|Reported Event|Placebo|"tasteless and inert tablets~Placebo: Tasteless and inert visually identical (to ibuprofen) pills"
646969|NCT02271854|B1|Baseline|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
646970|NCT02271854|P1|Participant Flow|Diclofenac Sodium Gel 1% and Placebo Gel|This study is a within-subject design i.e. diclofenac sodium gel 1% four times a day applied to one leg and placebo gel four times a day applied to the other leg to the other leg at the same time
646972|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
646973|NCT02271854|O2|Outcome|Placebo|"Placebo gel applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
646974|NCT02271854|O1|Outcome|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
646975|NCT02271854|E1|Reported Event|Diclofenac Sodium Gel 1%|"diclofenac sodium gel 1% applied four times daily~Diclofenac sodium gel 1%: Diclofenac sodium gel 1% four times daily"
646976|NCT02271698|B5|Baseline|Total|Total of all reporting groups
646977|NCT02271698|B4|Baseline|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
646978|NCT02271698|B3|Baseline|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646979|NCT02271698|B2|Baseline|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646980|NCT02271698|B1|Baseline|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646981|NCT02271698|P4|Participant Flow|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
646982|NCT02271698|P3|Participant Flow|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646983|NCT02271698|P2|Participant Flow|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646984|NCT02271698|P1|Participant Flow|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646985|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
646986|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646987|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646988|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
653880|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
646989|NCT02271698|O4|Outcome|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
646990|NCT02271698|O3|Outcome|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646991|NCT02271698|O2|Outcome|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
647106|NCT02268864|P1|Participant Flow|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
654463|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
646992|NCT02271698|O1|Outcome|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646993|NCT02271698|E4|Reported Event|Placebo|"Patients receive a placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Placebo: Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision."
646994|NCT02271698|E3|Reported Event|Dexamethasone 24mg|"Patients receive 24mg iv dexamethasone at surgical incision and a repeat dose of 24mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646995|NCT02271698|E2|Reported Event|Dexamethasone 12mg|"Patients receive 12mg iv dexamethasone at surgical incision and a repeat dose of 12mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646996|NCT02271698|E1|Reported Event|Dexamethasone 6mg|"Patients receive 6mg iv dexamethasone at surgical incision and a repeat dose of 6mg of dexamethasone 24h after incision. Pain scores and opioid consumption will be assessed using iv opioid patient controlled analgesia totals.~Dexamethasone: Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group"
646997|NCT02271529|B1|Baseline|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
646998|NCT02271529|P1|Participant Flow|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
646999|NCT02271529|O1|Outcome|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
647000|NCT02271529|E1|Reported Event|Zilver® Paclitaxel(PTX)® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
647001|NCT02271477|B3|Baseline|Total|Total of all reporting groups
647002|NCT02271477|B2|Baseline|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
647003|NCT02271477|B1|Baseline|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
647004|NCT02271477|P2|Participant Flow|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36%"
647005|NCT02271477|P1|Participant Flow|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
647017|NCT02270684|B2|Baseline|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
647782|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647006|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
647107|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
647007|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
647008|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
647009|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
647010|NCT02271477|O2|Outcome|Echocardiography|"In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation.~Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness"
647011|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
647012|NCT02271477|O2|Outcome|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
647013|NCT02271477|O1|Outcome|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
647014|NCT02271477|E2|Reported Event|Echocardiography|In addition to the current clinical standard, a Trans-Thoracic Echocardiography is performed before spinal anesthesia, with the aim of assessing the patient's volume status; the exam is performed to assess size and collapsing of the Inferior Vena Cava during breathing cycle. According to different pre-established parameters13, the patient is defined as fluid-responsive or unresponsive. If the patient is not responsive, investigators proceed to spinal anesthesia; otherwise they proceed to administration of crystalloid bolus (500 ml of NaCl 0.9% or Hartmann's solution). The patient may receive another bolus so as to reach a non-responsive pattern for echocardiographic evaluation. Ultrasound-guided volemic repletion: After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid).
647015|NCT02271477|E1|Reported Event|Wild-Type|The setting is standard spinal anesthesia and corresponds to our first arm of the study, used as the control sample and statistical reference. During the induction phase, the patient is fitted with non-invasive blood pressure monitoring, three-lead ECG, pulse-oximetry and peripheral intravenous device. Data and vital signs are recorded and an infusion of crystalloid (NaCl 0.9% or Ringer's acetate) is given during the procedure until the beginning of the operation. Total amount of fluid is also recorded before and after the spinal anesthesia.
647016|NCT02270684|B3|Baseline|Total|Total of all reporting groups
647783|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647018|NCT02270684|B1|Baseline|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
647019|NCT02270684|P2|Participant Flow|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
647108|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
647020|NCT02270684|P1|Participant Flow|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
647021|NCT02270684|O2|Outcome|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
647022|NCT02270684|O1|Outcome|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
647023|NCT02270684|E2|Reported Event|Usual and Customary Care|Participants in this arm will undergo usual care and will not be issued with the StepRite device
647024|NCT02270684|E1|Reported Event|Device|"Participants in this arm will receive the StepRite device. They will have a remote visit with their Physical Therapist in place of one in-person visit per week during the outpatient phase of their treatment~StepRite: The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete"
647025|NCT02270515|B1|Baseline|PCMH-KD Dialysis Care|Enrolled patients had access to an expanded care team inlcuding a primary care doctor, nurse coordinator, community health worker, and pharmacist.
647026|NCT02270515|P1|Participant Flow|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and a pharmacist.~Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
647027|NCT02270515|O4|Outcome|Change 0-18 Months|Change of mean score from Baseline (0) to 18 months
647028|NCT02270515|O3|Outcome|Change 12-18 Months|Change of mean score from 12 months to 18 months
647029|NCT02270515|O2|Outcome|Change 6-12 Months|Change of mean score from 6 months to 12 months
647030|NCT02270515|O1|Outcome|Change 0-6 Months|Change of mean score from Baseline (0) to 6 months
647031|NCT02270515|O4|Outcome|18 Months|KDQOL collected at 18 months
647032|NCT02270515|O3|Outcome|12 Months|KDQOL collected at 12 months
647033|NCT02270515|O2|Outcome|6 Months|KDQOL collected at 6 months
647034|NCT02270515|O1|Outcome|Baseline|KDQOL collected at Baseline
647035|NCT02270515|O4|Outcome|18 Months|KDQOL collected at 18 months
647036|NCT02270515|O3|Outcome|12 Months|KDQOL collected at 12 months
647037|NCT02270515|O2|Outcome|6 Months|KDQOL collected at 6 months
647038|NCT02270515|O1|Outcome|Baseline|KDQOL collected at Baseline
647039|NCT02270515|E1|Reported Event|PCMH-KD Dialysis Care|"Dialysis care team is expanded to include a primary care doctor, nurse coordinator, community health worker, and pharmacist.~Patient-Centered Medical Home for Kidney Disease (PCMH-KD): A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team."
647040|NCT02269657|B1|Baseline|Subject Cohort|Two bi-planar full spinal X-rays were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
647041|NCT02269657|P1|Participant Flow|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
647042|NCT02269657|O3|Outcome|Natural Standing Position|Subjects stood with their arms hanging on either side. Images were not taken but a pressure mat recording of the position of the arm center of pressure during this arm position was recorded.
647043|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647044|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647045|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647046|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
648627|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
647047|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647110|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24 week treatment after amendment.
647048|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647049|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647050|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647051|NCT02269657|O2|Outcome|Clavicle Position|Subjects stood with a 45 degree shoulder flexion with their knuckles on their clavicles. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647052|NCT02269657|O1|Outcome|Wall Position|Subjects stood with a 90 degree shoulder and elbow flexion with forearms and palms on the wall in front of them. Bi-planar low dose x-ray images of the spine and pelvis were taken with a pressure mat recording the position of the arm center of pressure in each arm position. Spinal and pelvic parameters and standing balance in different arm positions were measured.
647053|NCT02269657|E1|Reported Event|Subject Cohort|Two bi-planar full spinal X-ray were taken using the EOS® imaging system with subjects standing in two different positions. The first x-ray was taken while the subject's hands and forearms in front of them on the wall vertically. A second image was taken while the subject's knuckles loosely placed on ipsi-lateral clavicles. A pressure mat recorded the magnitude of pressure under the subjects' feet during each set of images.
647054|NCT02269488|B1|Baseline|MEDI3250|MEDI3250 was administered to all subjects.
647055|NCT02269488|P1|Participant Flow|MEDI3250|MEDI3250 was administered to all subjects.
647056|NCT02269488|O1|Outcome|MEDI3250|MEDI3250 was administered to all subjects.
647057|NCT02269488|E1|Reported Event|MEDI3250|MEDI3250 was administered to all subjects.
647058|NCT02269475|B3|Baseline|Total|Total of all reporting groups
647059|NCT02269475|B2|Baseline|Placebo|Placebo, 0.2mL as nasal spray
647060|NCT02269475|B1|Baseline|MEDI3250|MEDI3250, 0.2mL as nasal spray
647061|NCT02269475|P2|Participant Flow|Placebo|Placebo, 0.2mL as nasal spray
647062|NCT02269475|P1|Participant Flow|MEDI3250|MEDI3250, 0.2mL as nasal spray
647063|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
647064|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
647065|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
647066|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
647067|NCT02269475|O2|Outcome|Placebo|Placebo, 0.2mL as nasal spray
647068|NCT02269475|O1|Outcome|MEDI3250|MEDI3250, 0.2mL as nasal spray
647069|NCT02269475|E3|Reported Event|Total Number|
647070|NCT02269475|E2|Reported Event|Placebo|Placebo, 0.2mL as nasal spray
647071|NCT02269475|E1|Reported Event|MEDI3250|MEDI3250, 0.2mL as nasal spray
647072|NCT02269098|B3|Baseline|Total|Total of all reporting groups
647073|NCT02269098|B2|Baseline|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647074|NCT02269098|B1|Baseline|Intervention|"Diabetes survival skills self-management education (G meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED. ; plus diabetes medication management using medication algorithm ( Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
647075|NCT02269098|P2|Participant Flow|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647103|NCT02268864|B1|Baseline|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
647104|NCT02268864|P3|Participant Flow|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
647105|NCT02268864|P2|Participant Flow|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
647109|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
647230|NCT02266381|P3|Participant Flow|Combined-guided Group|Patients in combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
647076|NCT02269098|P1|Participant Flow|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
647077|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647078|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education; plus diabetes medication management using medication algorithm by diabetes educator supervised by endocrinologist, plus health system naviagation.~Metformin, sulfonylureas and basal insulin were included in the algorithm. Survival skills DSME included: BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.~Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Navigation included securing a primary care"
647079|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647080|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
647081|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647082|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
647083|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647084|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
647085|NCT02269098|O2|Outcome|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647178|NCT02267824|P1|Participant Flow|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
647086|NCT02269098|O1|Outcome|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
647087|NCT02269098|E2|Reported Event|Control|Usual ED care was provided to controls. Hyperglycemia was treated with rapid acting insulin and with IV hydration, if indicated. DM medications were added and/or doses were adjusted at the discretion of the ED physician and prescriptions provided. Insulin, however, was not prescribed as a new medication due to staff concerns regarding post-discharge hypoglycemia and lack of certainty of timely medical follow-up. Follow-up with primary care was recommended.
647088|NCT02269098|E1|Reported Event|Intervention|"Diabetes survival skills self-management education (BG meter instruction if the patient did not already have a meter or confirmation of self-BG monitoring technique if they did; instructions on how to self-inject insulin if prescribed; and information on BG targets, signs and treatment of hypoglycemia and hyperglycemia, basic nutrition information and when to call the doctor or go to the ED.); plus diabetes medication management using medication algorithm (Metformin, sulfonylureas and basal insulin were included in the algorithm) by diabetes educator supervised by endocrinologist, plus health system navigation.~.Diabetes medication management: As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care"
647089|NCT02268877|B3|Baseline|Total|Total of all reporting groups
647090|NCT02268877|B2|Baseline|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
647091|NCT02268877|B1|Baseline|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
647092|NCT02268877|P2|Participant Flow|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
647093|NCT02268877|P1|Participant Flow|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
647094|NCT02268877|O2|Outcome|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
647095|NCT02268877|O1|Outcome|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
647096|NCT02268877|O2|Outcome|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
647097|NCT02268877|O1|Outcome|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
647098|NCT02268877|E2|Reported Event|Radiology Tech Ultrasound|"Patients will receive an ultrasound performed by a credentialed radiology department technician. The ultrasound will be transabdominal, transvaginal, or both. This is standard-of-care.~Ultrasound: An ultrasound will be performed by a radiology department technician"
647099|NCT02268877|E1|Reported Event|Emergency Medicine Physician Ultrasound|"Patients will receive an ultrasound performed by a credentialed emergency medicine attending or resident. The ultrasound will be transabdominal, transvaginal, or both. The intervention is the personnel who performs the ultrasound.~Emergency Medicine Physician Ultrasound: An ultrasound will be performed by an emergency medicine resident or attending physician~Ultrasound: An ultrasound will be performed by a radiology department technician"
647100|NCT02268864|B4|Baseline|Total|Total of all reporting groups
647101|NCT02268864|B3|Baseline|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
647102|NCT02268864|B2|Baseline|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
647179|NCT02267824|O2|Outcome|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
647111|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12 week treatment period after amendment.
647112|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12 week treatment before Amendment 3 of the protocol was implemented.
647113|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
647114|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
647115|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
647116|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
647117|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
647118|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
647119|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
647120|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
647121|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
647122|NCT02268864|O3|Outcome|24 Weeks Extension|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for an extended 24-week treatment after amendment.
647123|NCT02268864|O2|Outcome|12 Weeks Post Amendment|Simeprevir 150 mg once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who opted for a 12-week treatment period after amendment.
647124|NCT02268864|O1|Outcome|12 Weeks Prior Amendment|Simeprevir 150 milligram (mg) once daily as an oral capsule in combination with daclatasvir 60 mg once daily as an oral tablet for participants who completed the 12-week treatment before Amendment 3 of the protocol was implemented.
647125|NCT02268864|E2|Reported Event|12-24 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has AEs that started after day 88 on treatment.
647126|NCT02268864|E1|Reported Event|1-12 Weeks|Simeprevir 150 mg once daily as an oral capsule in combination with Daclatasvir 60 mg once daily as an oral tablet for participants who has adverse events (AEs) that started before or on day 88 on treatment.
647127|NCT02268396|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647128|NCT02268396|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647129|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647130|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647131|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647132|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647133|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647134|NCT02268396|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647135|NCT02268396|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 μg
647136|NCT02268058|B5|Baseline|Total|Total of all reporting groups
647137|NCT02268058|B4|Baseline|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
647138|NCT02268058|B3|Baseline|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
647346|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647139|NCT02268058|B2|Baseline|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
647140|NCT02268058|B1|Baseline|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
647141|NCT02268058|P4|Participant Flow|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
647183|NCT02267629|B1|Baseline|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
647142|NCT02268058|P3|Participant Flow|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
647143|NCT02268058|P2|Participant Flow|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
647144|NCT02268058|P1|Participant Flow|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
647145|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
647146|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
647147|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
647148|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
647149|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
647150|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
647151|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
647152|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
647153|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
647154|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
647155|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
647156|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
647157|NCT02268058|O4|Outcome|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
647784|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647158|NCT02268058|O3|Outcome|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
647159|NCT02268058|O2|Outcome|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
647184|NCT02267629|P1|Participant Flow|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
647160|NCT02268058|O1|Outcome|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
647161|NCT02268058|E4|Reported Event|Tx 4: no Routine Meds and Education|"Patient was advised to manage headaches as they typically would. There was no instruction given for the routine administration of either ibuprofen or acetaminophen.~The Patient and family received standard education in the ER department and diarized their headaches and medications they took for a one week period."
647162|NCT02268058|E3|Reported Event|Tx 3: Ibuprofen/Acetaminophen/Education|"Patient took routinely ibuprofen (Q6H) and acetaminophen (Q4H) for when awake for 72 hours post concussion and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency Department.~Acetaminophen: routine administration of medication for a 72 hour period~Ibuprofen: routine administration of medication for a 72 hour period"
647163|NCT02268058|E2|Reported Event|Tx 2: Ibuprofen and Education|"Patient took routinely ibuprofen every 6 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Ibuprofen: routine administration of medication for a 72 hour period"
647164|NCT02268058|E1|Reported Event|tx 1: Acetaminophen and Education|"Patient took routinely acetaminophen every 4 hours when awake for a 72 hour period and documented their headaches for a week.~Patient and family received standard education on concussion management in the Emergency department.~Acetaminophen: routine administration of medication for a 72 hour period"
647165|NCT02267837|B3|Baseline|Total|Total of all reporting groups
647166|NCT02267837|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
647167|NCT02267837|B1|Baseline|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
647168|NCT02267837|P2|Participant Flow|No OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
647169|NCT02267837|P1|Participant Flow|OrthoPulse™|"Subjects assigned to this group receive fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
647170|NCT02267837|O2|Outcome|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
647171|NCT02267837|O1|Outcome|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
647172|NCT02267837|E2|Reported Event|No OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only, and no OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office."
647173|NCT02267837|E1|Reported Event|OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily OrthoPulse™ treatments.~Full mouth fixed orthodontic appliance treatment: Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.~OrthoPulse™: Patients carry out daily OrthoPulse™ treatments at home."
647174|NCT02267824|B3|Baseline|Total|Total of all reporting groups
647175|NCT02267824|B2|Baseline|Control|Subjects assigned to this group receive only full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), and no extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.
647176|NCT02267824|B1|Baseline|Extra-Oral OrthoPulse™|"Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI), in conjunction with receiving daily extra-oral OrthoPulse™ treatments. Treatment and follow-up appointments per the traditional practices of the PI and dental office.~Extra-Oral OrthoPulse™: Patients carry out daily extra-oral OrthoPulse™ treatments at home."
647177|NCT02267824|P2|Participant Flow|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment only.
647180|NCT02267824|O1|Outcome|Extraoral OrthoPulse® PBM and Orthodontic Treatment|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® PBM treatments.
647181|NCT02267824|E2|Reported Event|Orthodontic Treatment (Control)|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment, only.
647182|NCT02267824|E1|Reported Event|Extraoral OrthoPulse® PBM|Subjects assigned to this group receive full mouth fixed orthodontic appliance treatment in conjunction with receiving daily extraoral OrthoPulse® photobiomudulation (PBM) treatments.
648655|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
647185|NCT02267629|O1|Outcome|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
647186|NCT02267629|O1|Outcome|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
647187|NCT02267629|E1|Reported Event|Experimental:Rapastinel (Formerly GLYX-13)|"10 mg/kg IV Rapastinel (formerly GLYX-13) infusion followed by assessments daily for a week, and weekly for a week.~Rapastinel (formerly GLYX-13): 10 mg/kg IV Rapastinel (formerly GLYX-13)"
647188|NCT02266797|B3|Baseline|Total|Total of all reporting groups
647189|NCT02266797|B2|Baseline|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647190|NCT02266797|B1|Baseline|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647191|NCT02266797|P2|Participant Flow|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647192|NCT02266797|P1|Participant Flow|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647193|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647194|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647195|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647196|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647197|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647198|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647199|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647200|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647201|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647347|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647202|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647203|NCT02266797|O2|Outcome|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647228|NCT02266381|B2|Baseline|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
647229|NCT02266381|B1|Baseline|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
648656|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
647204|NCT02266797|O1|Outcome|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647205|NCT02266797|E2|Reported Event|Saline|"Subject will receive doses of intravenous physiological saline solution.~Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose."
647206|NCT02266797|E1|Reported Event|Dexamethasone|"Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.~Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose."
647207|NCT02266472|B3|Baseline|Total|Total of all reporting groups
647208|NCT02266472|B2|Baseline|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
647209|NCT02266472|B1|Baseline|Fed 10mg+1000mg FDC/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
647210|NCT02266472|P2|Participant Flow|Fed 10mg+1000mg Single/FDC (RT)|Subjects received in period 1 a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
647211|NCT02266472|P1|Participant Flow|Fed 10mg+1000mg Fixed Dose Combination (FDC)/Single (TR)|Subjects received in period 1 a single dose of 10 mg empagliflozin/1000 mg metformin hydrochloride (HCl) extended release (XR) (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 10 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal. 2 treatments separated by a wash-out period of at least 7 days.
647212|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
647213|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
647214|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
647215|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
647216|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
647217|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
647218|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
647219|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
647220|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
647221|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
647222|NCT02266472|O2|Outcome|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
647223|NCT02266472|O1|Outcome|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
647348|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647224|NCT02266472|E2|Reported Event|Fed 10mg+ 1000mg FDC (T)|Subjects received a single dose of 10 mg empagliflozin/1000 mg metformin HCl XR (1 tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
647225|NCT02266472|E1|Reported Event|Fed 10mg+1000mg Single (R)|Subjects received a single dose of 10 mg empagliflozin (1 tablet) together with a single dose of 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
647226|NCT02266381|B4|Baseline|Total|Total of all reporting groups
647227|NCT02266381|B3|Baseline|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
654464|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
647231|NCT02266381|P2|Participant Flow|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
647232|NCT02266381|P1|Participant Flow|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
647233|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
647234|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
647235|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
647236|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
647237|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
647238|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
647239|NCT02266381|O3|Outcome|Combined Group|Patients in Combined group undergo MPCNL using US combined with fluoroscopy-guided renal access.
647240|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
647241|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided undergo MPCNL using only US-guided renal access.
647242|NCT02266381|O3|Outcome|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
647243|NCT02266381|O2|Outcome|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
647244|NCT02266381|O1|Outcome|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
647245|NCT02266381|E3|Reported Event|Combined-guided Group|Patients in Combined-guided group undergo MPCNL using US combined with fluoroscopy-guided renal access.
647246|NCT02266381|E2|Reported Event|Fluoroscopy-guided Group|Patients in Fluoroscopy-guided group undergo MPCNL using only fluoroscopy-guided renal access.
647247|NCT02266381|E1|Reported Event|US-guided Group|Patients in US-guided group undergo MPCNL using only US-guided renal access.
647248|NCT02266277|B7|Baseline|Total|Total of all reporting groups
647249|NCT02266277|B6|Baseline|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
647250|NCT02266277|B5|Baseline|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647251|NCT02266277|B4|Baseline|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
647252|NCT02266277|B3|Baseline|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647253|NCT02266277|B2|Baseline|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647254|NCT02266277|B1|Baseline|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647255|NCT02266277|P6|Participant Flow|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
647256|NCT02266277|P5|Participant Flow|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647257|NCT02266277|P4|Participant Flow|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
647258|NCT02266277|P3|Participant Flow|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647785|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647259|NCT02266277|P2|Participant Flow|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647260|NCT02266277|P1|Participant Flow|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with Interactive Voice Recognition (IVR) call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647261|NCT02266277|O2|Outcome|IVR Self-Report|Patients who received IVR questionnaire.
647262|NCT02266277|O1|Outcome|Portal Self-Report|Patients who received portal questionnaire.
647263|NCT02266277|O6|Outcome|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
647264|NCT02266277|O5|Outcome|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647265|NCT02266277|O4|Outcome|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
647266|NCT02266277|O3|Outcome|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647267|NCT02266277|O2|Outcome|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647268|NCT02266277|O1|Outcome|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647269|NCT02266277|O6|Outcome|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
647270|NCT02266277|O5|Outcome|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647271|NCT02266277|O4|Outcome|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
647272|NCT02266277|O3|Outcome|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647273|NCT02266277|O2|Outcome|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647274|NCT02266277|O1|Outcome|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647275|NCT02266277|E6|Reported Event|Arm 6: No IVR Call|Patients identified as non e-portal users will not receive any outreach
647276|NCT02266277|E5|Reported Event|Arm 5: IVR Call|"Patients identified as non e-portal users will receive an IVR call only~Arm 5: IVR call: Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647277|NCT02266277|E4|Reported Event|Arm 4: No E-portal Message With no IVR Call|Patients identified as e-portal users will receive neither an e-portal message nor an IVR call
647278|NCT02266277|E3|Reported Event|Arm 3: No E-portal Message With IVR Call|"Patients identified as e-portal users will receive an IVR call only~Arm 3: No e-portal message with IVR call: Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647279|NCT02266277|E2|Reported Event|Arm 2: E-portal Message With no IVR Call|"Patients identified as e-portal users will receive an e-portal message only~Arm 2: E-portal message with no IVR call: Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647320|NCT02264249|P3|Participant Flow|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647280|NCT02266277|E1|Reported Event|Arm 1: E-portal Message With IVR Call|"Patients identified as e-portal users will receive an e-portal message with IVR call~Arm 1: E-portal message with IVR call: Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers."
647281|NCT02265848|B3|Baseline|Total|Total of all reporting groups
647282|NCT02265848|B2|Baseline|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647283|NCT02265848|B1|Baseline|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647284|NCT02265848|P2|Participant Flow|Treatment Group B|"Subjects randomized to the treatment group B will begin the 7 week study per sequence (e.g., Low frequency first, then High frequency and High frequency first, then Low frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
647285|NCT02265848|P1|Participant Flow|Treatment Group A|"Subjects randomized to the treatment group A will begin the 7 week study per sequence (e.g., High frequency first, then Low frequency and Low frequency first, then High frequency), with each stimulation modes lasting approximately 3 weeks with 7 to 10 days of wash off periods in between. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study."
647286|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647287|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647288|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647289|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647290|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647291|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647292|NCT02265848|O2|Outcome|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647321|NCT02264249|P2|Participant Flow|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647293|NCT02265848|O1|Outcome|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647323|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647324|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647294|NCT02265848|E2|Reported Event|Treatment Group B|Subjects randomized to the treatment group B will begin the 7 week study with low frequency (40 to 50Hz) paresthesia capture stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the high frequency (1000Hz) sub-perception stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647295|NCT02265848|E1|Reported Event|Treatment Group A|Subjects randomized to the treatment group A will begin the 7 week study with high frequency (1000Hz) sub-perception stimulation for first 3 weeks of the study. After first 3 weeks, subject will return to clinic to turn off the SCS device, and will start 7-10 days of wash off period. At the end of the wash off period, subject will return to clinic and have the SCS device turned on to have it programmed to deliver the low frequency stimulation for the next 3 weeks. At the end of the 7th week, the subject will return for final end of treatment visit for conclusion of the study.
647296|NCT02265783|B1|Baseline|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
647297|NCT02265783|P1|Participant Flow|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
647298|NCT02265783|O1|Outcome|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
647299|NCT02265783|E1|Reported Event|The Oxicable Pulse Oximetry Device|The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
647300|NCT02264821|B4|Baseline|Total|Total of all reporting groups
647301|NCT02264821|B3|Baseline|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
647302|NCT02264821|B2|Baseline|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
647303|NCT02264821|B1|Baseline|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
647304|NCT02264821|P3|Participant Flow|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
647305|NCT02264821|P2|Participant Flow|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
647306|NCT02264821|P1|Participant Flow|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
647307|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
647308|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
647309|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
647310|NCT02264821|O3|Outcome|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
647311|NCT02264821|O2|Outcome|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
647312|NCT02264821|O1|Outcome|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
647313|NCT02264821|E3|Reported Event|Placebo|"intrathecal saline and saline infiltration~placebo: placebo in spinal anaesthesia and in wound infiltration"
647314|NCT02264821|E2|Reported Event|Rachi Morphine|"100 µg intrathecal morphine and saline infiltration~intrathecal morphine: 100 µg added to the spinal anaesthesia"
647315|NCT02264821|E1|Reported Event|Ropivacaine Infiltration|"ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline~ropivacaine infiltration: wound infiltration"
647316|NCT02264249|B4|Baseline|Total|Total of all reporting groups
647317|NCT02264249|B3|Baseline|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647318|NCT02264249|B2|Baseline|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647319|NCT02264249|B1|Baseline|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647322|NCT02264249|P1|Participant Flow|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647354|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets given orally (PO) once daily (QD) in the fasted state on Day 1 in one of five periods.
654465|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
647325|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647326|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647327|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647328|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647329|NCT02264249|O3|Outcome|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647330|NCT02264249|O2|Outcome|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647331|NCT02264249|O1|Outcome|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647332|NCT02264249|E3|Reported Event|Same Day Prep Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Same day prep (4L volume or 2L volume or Miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647333|NCT02264249|E2|Reported Event|Evening Before Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - Evening before (4L, 2L or miralax bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647334|NCT02264249|E1|Reported Event|Split Dose Colonoscopy Preparation|"Esophagogastroduodenoscopy and colonoscopy - split dose – ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)~Esophagogastroduodenoscopy and colonoscopy: Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy."
647335|NCT02263911|B1|Baseline|Overall Study|All randomized participants.
647336|NCT02263911|P4|Participant Flow|Baricitinib Dosing Sequence 4|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
647337|NCT02263911|P3|Participant Flow|Baricitinib Dosing Sequence 3|Single oral dose of study drug daily on 5 occasions: T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
647338|NCT02263911|P2|Participant Flow|Baricitinib Dosing Sequence 2|Single oral dose of study drug daily on 5 occasions: R1 = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, T1 = Baricitinib 2 × 4 mg commercial formulation tablets in a fasted state, R2 = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, T2 = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, and T2F = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
647339|NCT02263911|P1|Participant Flow|Baricitinib Dosing Sequence 1|Single oral dose of study drug daily on 5 occasions: Test Treatment 1 (T1) = Baricitinib 2 × 4 milligram (mg) commercial formulation tablets in a fasted state, Reference Treatment 1 (R1) = Baricitinib 1 × 8 mg Phase 2 tablet in a fasted state, Test Treatment 2 (T2) = Baricitinib 1 × 4 mg commercial formulation tablet in a fasted state, Reference Treatment 2 (R2) = Baricitinib 1 × 4 mg Phase 2 tablet in a fasted state, and (T2F) = Baricitinib 2 × 4 mg commercial formulation tablets in a fed state. Dosing occasions were separated by at least 7 days.
647340|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
647341|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647342|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647343|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647344|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647345|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
647349|NCT02263911|O1|Outcome|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
647350|NCT02263911|O5|Outcome|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
647351|NCT02263911|O4|Outcome|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647352|NCT02263911|O3|Outcome|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647353|NCT02263911|O2|Outcome|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
648657|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
647355|NCT02263911|E5|Reported Event|Baricitinib T2F|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD with a low-fat meal on Day 1 in one of five periods.
647356|NCT02263911|E4|Reported Event|Baricitinib R2|Baricitinib 1 × 4 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647357|NCT02263911|E3|Reported Event|Baricitinib T2|Baricitinib 1 × 4 mg commercial formulation tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647358|NCT02263911|E2|Reported Event|Baricitinib R1|Baricitinib 1 × 8 mg Phase 2 tablet administered PO QD in the fasted state on Day 1 in one of five periods.
647359|NCT02263911|E1|Reported Event|Baricitinib T1|Baricitinib 2 × 4 mg commercial formulation tablets administered PO QD in the fasted state on Day 1 in one of five periods.
647360|NCT02263833|B1|Baseline|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
647361|NCT02263833|P1|Participant Flow|Overall Participants|Participants not previously on erythropoietin-stimulating agent (ESA) therapy and participants on ESA therapy who were prescribed Mircera either subcutaneously (SC) or intravenously (IV) according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
647362|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
647363|NCT02263833|O1|Outcome|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
647364|NCT02263833|E1|Reported Event|Overall Participants|Participants not previously on ESA therapy and participants on ESA therapy who were prescribed Mircera either SC or IV according to local Korean Mircera label and at physician’s discretion were observed as per physician’s discretion, approximately up to 4 years.
647365|NCT02263131|B3|Baseline|Total|Total of all reporting groups
647366|NCT02263131|B2|Baseline|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
647367|NCT02263131|B1|Baseline|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
647368|NCT02263131|P2|Participant Flow|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
647369|NCT02263131|P1|Participant Flow|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
647370|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
647371|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
647372|NCT02263131|O2|Outcome|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
647373|NCT02263131|O1|Outcome|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
647374|NCT02263131|E2|Reported Event|TIV PFS|"VAXIGRIP Prefilled Syringe INJ.~VAXIGRIP Prefilled Syringe INJ.: VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL"
647375|NCT02263131|E1|Reported Event|IL-YANG PFS|"IL-YANG FLU Vaccine Prefilled Syringe INJ.~IL-YANG FLU Vaccine Prefilled Syringe INJ.: IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL"
647376|NCT02263118|B5|Baseline|Total|Total of all reporting groups
647377|NCT02263118|B4|Baseline|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
647378|NCT02263118|B3|Baseline|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
647379|NCT02263118|B2|Baseline|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
647380|NCT02263118|B1|Baseline|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
647381|NCT02263118|P4|Participant Flow|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
648628|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
647382|NCT02263118|P3|Participant Flow|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
647383|NCT02263118|P2|Participant Flow|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
654466|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
647384|NCT02263118|P1|Participant Flow|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
647385|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
647386|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
647387|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
647388|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
647389|NCT02263118|O4|Outcome|Control Group|"There were no virtual communities in this group: individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
647390|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
647391|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
647392|NCT02263118|O1|Outcome|Uni-directional SMS|"There were no virtual communities in this group: participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
647393|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
647394|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
647395|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
647396|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
647397|NCT02263118|O4|Outcome|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
647398|NCT02263118|O3|Outcome|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
647399|NCT02263118|O2|Outcome|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
647400|NCT02263118|O1|Outcome|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
647401|NCT02263118|E4|Reported Event|Control Group|"Individuals were given a feature phone (simple mobile phone)~Feature phone: Participants were given a feature phone."
647402|NCT02263118|E3|Reported Event|Hybrid Setup|"Participants were made part of virtual communities in which they could exchange about infant's health as groups, via SMS. Additionally, a health professional was included in the virtual community.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS~Hybrid setup: Exposure to virtual community and access to communications with health professional via SMS"
647434|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
648658|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
647403|NCT02263118|E2|Reported Event|Virtual Communities|"Participants were made part of virtual communities in which could exchange about infant's health as groups, via SMS, following the SHM Foundation's (http://www.shmfoundation.org/) m-health methodology.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone.~Virtual communities: Exposure to virtual community communication via SMS"
647404|NCT02263118|E1|Reported Event|Uni-directional SMS|"Participants in this group received breastfeeding promoting messages based on the MAMA (http://www.mobilemamaalliance.org/) breastfeeding database. Individuals could only receive text messages.~Uni-directional SMS: Exposure to breastfeeding promoting SMSs~Feature phone: Participants were given a feature phone."
647405|NCT02262754|B4|Baseline|Total|Total of all reporting groups
647406|NCT02262754|B3|Baseline|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647407|NCT02262754|B2|Baseline|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647408|NCT02262754|B1|Baseline|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647409|NCT02262754|P3|Participant Flow|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647410|NCT02262754|P2|Participant Flow|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647411|NCT02262754|P1|Participant Flow|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647412|NCT02262754|O1|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647413|NCT02262754|O1|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647414|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647415|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647416|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647417|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647418|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647419|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647420|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647421|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647422|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647423|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647424|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647425|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647426|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647427|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647428|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647429|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647430|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
648629|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
647431|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647432|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647433|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647435|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647436|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647437|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647438|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647439|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647440|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647441|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647442|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647443|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647444|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647445|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647446|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647447|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647448|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647449|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647450|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647451|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647452|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647453|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647454|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647455|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647456|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647457|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647458|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647459|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647460|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647461|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647462|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647463|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647464|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647465|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647466|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647467|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647468|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647469|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647470|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647471|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647472|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647473|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647474|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647475|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647476|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647477|NCT02262754|O3|Outcome|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647478|NCT02262754|O2|Outcome|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647479|NCT02262754|O1|Outcome|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647480|NCT02262754|E3|Reported Event|Naproxen|Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
647481|NCT02262754|E2|Reported Event|PF-06372865|Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
647482|NCT02262754|E1|Reported Event|Placebo|Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.
647483|NCT02262728|B3|Baseline|Total|Total of all reporting groups
647484|NCT02262728|B2|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647485|NCT02262728|B1|Baseline|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647486|NCT02262728|P2|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647487|NCT02262728|P1|Participant Flow|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647488|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647489|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647490|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647491|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647786|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647492|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647493|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647514|NCT02262078|B3|Baseline|Total|Total of all reporting groups
647494|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647495|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647496|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647497|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647498|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647499|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647500|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647501|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647502|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647503|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647504|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647505|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647506|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647507|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647508|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647509|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647510|NCT02262728|O2|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647511|NCT02262728|O1|Outcome|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647787|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647512|NCT02262728|E2|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh B|Participants with Child-Pugh score 7 to 9 (extremes included) received simeprevir (SMV) (150 mg capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647513|NCT02262728|E1|Reported Event|SMV 150mg/DCV 60mg/SOF 400mg - Child-Pugh A|Participants with Child-Pugh score <7 with evidence of portal hypertension (confirmed by presence of esophageal varices or hepatic venous pressure gradient [HVPG] greater than or equal to 10 millimeter of mercury [mm Hg]) received simeprevir (SMV) (150 milligram [mg] capsule), daclatasvir (DCV) (60 mg tablet) and sofosbuvir (SOF) (400 mg tablet) orally once daily for 12 weeks.
647515|NCT02262078|B2|Baseline|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
647516|NCT02262078|B1|Baseline|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
647517|NCT02262078|P2|Participant Flow|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
647518|NCT02262078|P1|Participant Flow|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
647519|NCT02262078|O2|Outcome|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
647520|NCT02262078|O1|Outcome|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
647521|NCT02262078|E2|Reported Event|Sodium Nitrite|"Participants receive Sodium Nitrite inhalation solution, administered by inhalation over 10-15 minutes, using a nebulizer~Sodium Nitrite Inhalation Solution: 90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise."
647522|NCT02262078|E1|Reported Event|Placebo (Saline)|"Participants receive normal saline, administered by inhalation over 10-15 minutes, using a nebulizer~Placebo: Normal saline will be administered (by inhalation) to participants prior to exercise."
647523|NCT02262039|B3|Baseline|Total|Total of all reporting groups
647524|NCT02262039|B2|Baseline|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647525|NCT02262039|B1|Baseline|Conventional Pressure|15mmHg target pressure
647526|NCT02262039|P2|Participant Flow|Low Pressure (VTI)|"10mmHg target pressure~VTI = Valveless recirculating insufflation"
647527|NCT02262039|P1|Participant Flow|Conventional Pressure|15mmHg target pressure
647528|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647529|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
647530|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647531|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
647532|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647533|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
647534|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647535|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
647536|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647537|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
647538|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647539|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
647540|NCT02262039|O2|Outcome|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647541|NCT02262039|O1|Outcome|Conventional Pressure|15mmHg target pressure
647542|NCT02262039|E2|Reported Event|Low Pressure (VTI)|"10mmHg target pressure~VTI= Valveless recirculating insufflation"
647543|NCT02262039|E1|Reported Event|Conventional Pressure|15mmHg target pressure
647544|NCT02261948|B3|Baseline|Total|Total of all reporting groups
647545|NCT02261948|B2|Baseline|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647546|NCT02261948|B1|Baseline|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647730|NCT02258412|E1|Reported Event|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
647588|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647589|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647590|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
648659|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
647547|NCT02261948|P2|Participant Flow|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647548|NCT02261948|P1|Participant Flow|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647549|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647550|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647551|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647552|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647553|NCT02261948|O2|Outcome|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647554|NCT02261948|O1|Outcome|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647586|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647587|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647555|NCT02261948|E2|Reported Event|Placebo|"Placebo must be diluted before the administration (500 ml of glucose). The intravenous infusion may' be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Placebo: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647556|NCT02261948|E1|Reported Event|Levosimendan|"Levosimendan must be diluted before the administration (500 ml of glucose). The intravenous infusion may be administered either by the peripheral or central. The dose and duration of therapy should be decided according to the patient's clinical condition and response to the drug. Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min. A low infusion bolus (6 mcg / kg) is recommended for patients who have a concomitant intravenous treatment with vasodilators or inotropic. The patient's response should be evaluated during the infusion bolus or within 30 to 60 minutes and a dose adjustment based on clinical response.~Levosimendan: Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min."
647557|NCT02261428|B3|Baseline|Total|Total of all reporting groups
647558|NCT02261428|B2|Baseline|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with Suction catheter . After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
647559|NCT02261428|B1|Baseline|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
647560|NCT02261428|P2|Participant Flow|Suction Catheter First, Then Catheter Tiemann|Participants first received nasotracheal suction with suction catheter. After a washout period minimum of half hour they received a second nasotracheal suction with catheter Tiemann.
647561|NCT02261428|P1|Participant Flow|Catheter Tiemann First, Then Suction Catheter|Participants first received nasotracheal suction with catheter Tiemann. After a washout period minimum of half hour they received a second nasotracheal suction with Suction catheter
647562|NCT02261428|O2|Outcome|Suction Catheter|Presence of blood was found on Participants immediately after suctioning with Suction catheter
647563|NCT02261428|O1|Outcome|Catheter Tiemann|Presence of blood was found on Participants immediately after suctioning with catheter Tiemann
647564|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
647565|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of diastolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
647566|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth Suction catheter
647567|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of systolic blood pressure recorded immediately after insertion to trachea wth catheter Tiemann.
647568|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth Suction catheter
647569|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of heart rate recorded immediately after insertion to trachea wth catheter Tiemann.
647570|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth Suction catheter
647571|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of respiratory rate recorded immediately after insertion to trachea wth catheter Tiemann.
647572|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of time required to insert the trachea wth Suction catheter
647573|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of time required to insert the trachea wth catheter Tiemann.
647574|NCT02261428|O2|Outcome|Suction Catheter|The number below represents the mean of attempts made wth Suction catheter.
647575|NCT02261428|O1|Outcome|Catheter Tiemann|The number below represents the mean of attempts made wth catheter Tiemann.
647576|NCT02261428|E2|Reported Event|Suction Catheter|Participants received nasotracheal suction with Suction catheter
647577|NCT02261428|E1|Reported Event|Catheter Tiemann|Participants received nasotracheal suction with catheter Tiemann.
647578|NCT02260882|B3|Baseline|Total|Total of all reporting groups
647579|NCT02260882|B2|Baseline|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647580|NCT02260882|B1|Baseline|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647581|NCT02260882|P2|Participant Flow|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647582|NCT02260882|P1|Participant Flow|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647583|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647584|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647585|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647731|NCT02258334|B5|Baseline|Total|Total of all reporting groups
647591|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647592|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647593|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647594|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647595|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647596|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647597|NCT02260882|O2|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647598|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647599|NCT02260882|O1|Outcome|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647600|NCT02260882|O1|Outcome|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647601|NCT02260882|E2|Reported Event|Primary Vaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who have never received PNEUMOVAX™ 23 vaccination.
647602|NCT02260882|E1|Reported Event|Revaccination Group|0.5 mL intramuscular injection (deltoid or lateral mid-thigh) of PNEUMOVAX™ 23 vaccine on Day 1 for participants who received an initial vaccination at least 5 years prior.
647603|NCT02260492|B4|Baseline|Total|Total of all reporting groups
647604|NCT02260492|B3|Baseline|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
647605|NCT02260492|B2|Baseline|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
647606|NCT02260492|B1|Baseline|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
647607|NCT02260492|P3|Participant Flow|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
647608|NCT02260492|P2|Participant Flow|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
647609|NCT02260492|P1|Participant Flow|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
647610|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
647611|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
647612|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
647613|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
647614|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
647615|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
647616|NCT02260492|O3|Outcome|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
647617|NCT02260492|O2|Outcome|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
647732|NCT02258334|B4|Baseline|Group 4|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
653881|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
647618|NCT02260492|O1|Outcome|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
647619|NCT02260492|E3|Reported Event|Placebo|"Placebo (twice daily inhalation throughout the study)~Placebo: Placebo (lactose) administered via the Solis dry powder inhaler"
647733|NCT02258334|B3|Baseline|Group 3|Adults ≥ 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647620|NCT02260492|E2|Reported Event|Advair Diskus|"Advair Diskus (twice daily inhalation throughout the study)~Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler"
647621|NCT02260492|E1|Reported Event|OT329 Solis|"OT329 Solis (twice daily inhalation throughout the study)~OT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler"
647622|NCT02260440|B1|Baseline|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
647623|NCT02260440|P1|Participant Flow|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
647624|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
647625|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
647626|NCT02260440|O1|Outcome|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
647627|NCT02260440|E1|Reported Event|Pembrolizumab and Azacitidine|"200 mg of Pembrolizumab was administered intravenously over 30 minutes on Day 1 of every 21 day cycle. 100 mg of Azacitidine was given daily via subcutaneous injection on days 1-5 every 21 days.~Treatment continued for 9 cycles (about 27 weeks) or until there was an evidence of progression of disease (PD) or unacceptable toxicity before the completion of the planned 9 cycles."
647628|NCT02260401|B3|Baseline|Total|Total of all reporting groups
647629|NCT02260401|B2|Baseline|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
647630|NCT02260401|B1|Baseline|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
647631|NCT02260401|P2|Participant Flow|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
647632|NCT02260401|P1|Participant Flow|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
647633|NCT02260401|O2|Outcome|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
647634|NCT02260401|O1|Outcome|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
647635|NCT02260401|E2|Reported Event|Individualized Reports After 24 Months|Patients in this group will receive the individualized report, but will not receive it until after the conclusion of the study at 24 months. They will serve as the control group.
647636|NCT02260401|E1|Reported Event|Individualized Report|"Each patient in this group will receive an individualized report with their own outcome data (pain and function) during the first year of the LESS trial. They will receive these reports at 18 months.~Individualized report: Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)"
647637|NCT02259608|B1|Baseline|yBCG|15 healthy volunteers that receive yBCG at baseline. There is no control group included in this trial.
647638|NCT02259608|P1|Participant Flow|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
647639|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
647640|NCT02259608|O1|Outcome|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
647734|NCT02258334|B2|Baseline|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
647641|NCT02259608|E1|Reported Event|BCG Vaccine SSI|"Healthy volunteers are vaccinated with yBCG. Blood will be drawn before and at several timepoints after vaccination. Cytokine production before vaccination will be used as reference to compare later timepoints with.~BCG vaccine SSI: BCG vaccination"
647642|NCT02259400|B3|Baseline|Total|Total of all reporting groups
647643|NCT02259400|B2|Baseline|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647644|NCT02259400|B1|Baseline|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647645|NCT02259400|P2|Participant Flow|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647646|NCT02259400|P1|Participant Flow|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647647|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647648|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647649|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647735|NCT02258334|B1|Baseline|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647736|NCT02258334|P4|Participant Flow|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
647650|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647651|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647652|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647653|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647654|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647655|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647656|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647709|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647781|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647657|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647658|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647659|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647660|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647661|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647662|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647663|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647710|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
648630|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
647664|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647665|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647666|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647667|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647668|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647669|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647670|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647711|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647671|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647672|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647673|NCT02259400|O2|Outcome|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647674|NCT02259400|O1|Outcome|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647675|NCT02259400|E2|Reported Event|BiPAP Group|"The BiPAP is a modality of noninvasive respiratory support that provides two alternate different levels of CPAP in which the babies can breath spontaneously. The BiPAP will be delivered by the Infant Flow-driver device (Infant Flow System, Vyasis Corp,Yorba Linda, California (CA),USA) and bi-nasal prongs as interface (Vyasis Corp,Yorba Linda, CA,USA) with different size according to infants’ weight.~BiPAP: In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3."
647676|NCT02259400|E1|Reported Event|NSIPPV Group|"The NSIPPV is a conventional modality of mechanical ventilation delivered by the nasal ventilator device Giulia (Ginevri, Rome, Italy), that in noninvasive modality detects the inspiratory effort by means of a pneumotachograph, equipped with a fixed orifice (2 mm in diameter), positioned proximally to the nasal interface. Short bi-nasal prongs (NIV set, Ginevri, Rome, Italy), with different size according to infants’weight, will be used as interface.~NSIPPV: In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3."
647677|NCT02259348|B1|Baseline|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647678|NCT02259348|P1|Participant Flow|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647679|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647680|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647681|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647682|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647683|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647684|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647685|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647686|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647687|NCT02259348|O1|Outcome|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
648631|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
647688|NCT02259348|E1|Reported Event|Participants|"Participants undergo a conditioning regimen with cyclophosphamide, fludarabine, aldesleukin (interleukin-2), natural killer cell therapy, anti-thymocyte globulin, rituximab, thiotepa, and melphalan prior to transplantation of T-cell depleted HPC transplant on day 0 and CD45RA-depleted HPC transplant on day 1. Beginning Day 6 post-transplant, patients receive G-CSF daily until ANC recovers to normal level.~Cyclophosphamide: Given intravenously (IV)~Fludarabine: Given IV~G-CSF: Given IV or subcutaneously (SQ)~Interleukin-2: Given SQ~Melphalan: Given IV~Thiotepa: Given IV~Rituximab: Given IV~Natural killer cell therapy: Given IV~T-cell depleted HPC transplant: T-cell depleted hematopoietic stem cells will be infused on day 0.~CD45RA-depleted HPC transplant: CD45RA depleted stem cells will be infused on day 1."
647689|NCT02258529|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647690|NCT02258529|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647691|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647692|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647693|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647694|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647695|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647696|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647697|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647698|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647699|NCT02258529|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647700|NCT02258529|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily for up to 104 weeks + rituximab 375 mg/m^2 intravenously (once weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
647701|NCT02258477|B1|Baseline|All Study Subjects|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Glucose: This is a randomized, double-blind cross-over pilot study involving 40 study subjects. We will compare the efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food. After baseline data collection, eligible participants will be randomized into one of the four sequence group and receive a different beverage each week."
647702|NCT02258477|P4|Participant Flow|Sequence 4 (B-C-D-A)|Subjects in sequence 4 received 10 calorie beverage in week 1, 50 calorie beverage in week 2, 100 calorie beverage in week 3, and 0 calorie control beverage in week 4.
647703|NCT02258477|P3|Participant Flow|Sequence 3 (C-A-B-D)|Subjects in sequence 3 received 50 calorie beverage in week 1, 0 calorie control beverage in week 2, 20 calorie beverage in week 3, and 100 calorie beverage in week 4.
647704|NCT02258477|P2|Participant Flow|Sequence 2 (A-D-C-B)|Subjects in sequence 2 received 0 calorie control beverage in week 1, 100 calorie beverage in week 2, 50 calorie beverage in week 3, and 10 calorie beverage in week 4.
647705|NCT02258477|P1|Participant Flow|Sequence 1 (D-B-A-C)|Subjects assigned to sequence 1 received 100 calorie beverage in week 1, 10 calorie beverage in week 2, 0 calorie control beverage in week 3, and 50 calorie beverage in week 4.
647706|NCT02258477|O4|Outcome|10 cal Glucose Beverage|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647707|NCT02258477|O3|Outcome|50 cal Glucose Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647708|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
648632|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
647712|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
647713|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647714|NCT02258477|O4|Outcome|10 Calorie|"Compare the efficacy of a 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647715|NCT02258477|O3|Outcome|50 Calorie Beverage|"Compare the efficacy of a 50 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647716|NCT02258477|O2|Outcome|100 Calorie Glucose Beverage|"Compare the efficacy of a 100 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence group and receive each treatment for 1 week."
647717|NCT02258477|O1|Outcome|Control|"Compare the efficacy of 0 calorie sucralose-sweetened water on the behavioral ease of resisting problem foods during time of vulnerability to the problem food.~Efficacy of a 100, 50, and 10 calorie glucose beverage versus an identical volume of placebo beverage (0 calorie sucralose-sweetened water) on the behavioral ease of resisting problem foods during time of vulnerability to the problem food was compared. After baseline data collection, eligible participants were randomized into one of the four sequence groups and received each treatment for 1 week."
647718|NCT02258477|E1|Reported Event|All Study Subjects|Subjects were randomized into four possible sequences: subjects assigned to sequence 1 received the control beverage first during week 1, then the 10 calorie beverage during week 2, then the 50 calorie beverage during week 3, and then the 100 calorie beverage during week 4. Subjects assigned to sequence 2 received received the 50 calorie beverage during week 1, then the 100 calorie beverage during week 2, then the control beverage during week 3, and then the 50 calorie beverage during week 4. Subejcts assigned to sequence 3 received the 50 calorie beverage during week 1, then the control beverage during week 2, then the 100 calorie beverage during week 3, and then the 10 calorie beverage during week 4. Subjects assigned to sequence 4 received the 100 calorie beverage during week 1, then the 50 calorie beverage during week 2, then the 10 calorie beverage during week 3, and then the control beverage during week 4.
647719|NCT02258412|B4|Baseline|Total|Total of all reporting groups
647720|NCT02258412|B3|Baseline|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
647721|NCT02258412|B2|Baseline|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
647722|NCT02258412|B1|Baseline|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
647723|NCT02258412|P3|Participant Flow|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
647724|NCT02258412|P2|Participant Flow|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
647725|NCT02258412|P1|Participant Flow|Alcohol + CHG First|Healthcare workers who received product with alcohol + CHG prior to product with alcohol only
647726|NCT02258412|O2|Outcome|Hand Antiseptic With CHG and Alcohol|"Hand antiseptic is applied by dispensing 1 pump into hands, spreading over the hands up to the wrist, and rubbing until dry. Hand antiseptic will be used twice approximately 15-30 minutes apart on one day.~hand antiseptic with CHG and alcohol: HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers."
647727|NCT02258412|O1|Outcome|Alcohol Hand Sanitizer Foam|"Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day.~Alcohol hand sanitizer foam: Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day"
647728|NCT02258412|E3|Reported Event|Patient|Patients received no treatment, but were cared for by healthcare workers who enrolled in the study
647729|NCT02258412|E2|Reported Event|Alcohol Only First|Healthcare workers who received product with alcohol only prior to product with alcohol + CHG
647737|NCT02258334|P3|Participant Flow|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647738|NCT02258334|P2|Participant Flow|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
647739|NCT02258334|P1|Participant Flow|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647740|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
647741|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647742|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
647743|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647744|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
647745|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647746|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
647747|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647748|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
647749|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647750|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal of Fluzone Intradermal vaccine.
647751|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647752|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
647753|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647754|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
647755|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647756|NCT02258334|O4|Outcome|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High-Dose vaccine.
647757|NCT02258334|O3|Outcome|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647758|NCT02258334|O2|Outcome|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
647759|NCT02258334|O1|Outcome|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647760|NCT02258334|E4|Reported Event|Group 4|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone High Dose vaccine.
647761|NCT02258334|E3|Reported Event|Group 3|Adults ≥65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647762|NCT02258334|E2|Reported Event|Group 2|Adults 18 to < 65 years of age randomly assigned to receive an intradermal dose of Fluzone Intradermal vaccine.
647763|NCT02258334|E1|Reported Event|Group 1|Adults 18 to < 65 years of age randomly assigned to receive an intramuscular dose of Fluzone Quadrivalent vaccine.
647764|NCT02257918|B4|Baseline|Total|Total of all reporting groups
647765|NCT02257918|B3|Baseline|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647766|NCT02257918|B2|Baseline|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647767|NCT02257918|B1|Baseline|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647768|NCT02257918|P3|Participant Flow|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647769|NCT02257918|P2|Participant Flow|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647770|NCT02257918|P1|Participant Flow|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647771|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647772|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647773|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647774|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647775|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647776|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647777|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647778|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647779|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647780|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
653882|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
647788|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647789|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647790|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647791|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647792|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647793|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647794|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647795|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647796|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647797|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647798|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647799|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647800|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647801|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647802|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647803|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647804|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647805|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647806|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647807|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647808|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647809|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647810|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647811|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647812|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647813|NCT02257918|O3|Outcome|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647814|NCT02257918|O2|Outcome|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647815|NCT02257918|O1|Outcome|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647816|NCT02257918|E3|Reported Event|Ceftriaxone 500mg|Participants receive single intramuscular dose of 500 mg of ceftriaxone.
647817|NCT02257918|E2|Reported Event|AZD0914/ETX0914 3000mg|Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.
647818|NCT02257918|E1|Reported Event|AZD0914/ETX0914 2000mg|Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.
647819|NCT02257684|B1|Baseline|Pegcrisantaspase|pegcrisantaspase
647820|NCT02257684|P1|Participant Flow|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
647821|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
647822|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
647823|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
647824|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
647825|NCT02257684|O1|Outcome|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
647826|NCT02257684|E1|Reported Event|Pegcrisantaspase|IV administration of pegcrisantaspase in Course 1
647827|NCT02257385|B3|Baseline|Total|Total of all reporting groups
647828|NCT02257385|B2|Baseline|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647829|NCT02257385|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647830|NCT02257385|P2|Participant Flow|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647831|NCT02257385|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647832|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647833|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
648001|NCT02255279|B2|Baseline|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
647834|NCT02257385|O2|Outcome|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647835|NCT02257385|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647836|NCT02257385|E2|Reported Event|Indacaterol 150 µg + Tiotropium Bromide 18 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing placebo, BREEZHALER containing indacaterol 150 µg, and HANDIHALER containing tiotropium bromide 18 µg. The inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647837|NCT02257385|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose each morning from each of the following three inhalers for 12 weeks: ELLIPTA dry powder inhaler containing umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg), BREEZHALER containing placebo, and HANDIHALER containing placebo. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
647838|NCT02257372|B3|Baseline|Total|Total of all reporting groups
647839|NCT02257372|B2|Baseline|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
647840|NCT02257372|B1|Baseline|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
647841|NCT02257372|P2|Participant Flow|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
647842|NCT02257372|P1|Participant Flow|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
647843|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
647844|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
647845|NCT02257372|O2|Outcome|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed
647846|NCT02257372|O1|Outcome|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
647847|NCT02257372|E2|Reported Event|Umeclidinium 62.5 mcg+ICS/LABA|Participants received Umeclidinium 62.5 microgram(mcg) via a DPI once daily and an open-label ICS/LABA administered according to label instructions for 12 weeks. Participants also received albuterol/salbutamol via a MDI or nebules as rescue medication throughout the study for use as needed.
647848|NCT02257372|E1|Reported Event|Placebo+ICS/LABA|Participants received double-blind placebo via a dry powder inhaler (DPI) once daily and an open-label inhaled corticosteriod (ICS)/Long-acting beta2-agonist(LABA) administered according to the label instructions for 12 weeks. Participants also received albuterol/salbutamol via a metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed
647849|NCT02256982|B3|Baseline|Total|Total of all reporting groups
647850|NCT02256982|B2|Baseline|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
647851|NCT02256982|B1|Baseline|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
647885|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
654467|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
647852|NCT02256982|P2|Participant Flow|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
647853|NCT02256982|P1|Participant Flow|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
647854|NCT02256982|O2|Outcome|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
647855|NCT02256982|O1|Outcome|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
647856|NCT02256982|E2|Reported Event|Unresectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to radiation therapy with protons or photons, determined by available resources~Additional cycles of GEM + CDDP on a 21 day cycle as recommended by treating medical oncologist~Gemcitabine~Cisplatin~Radiation: Radiation Therapy"
647857|NCT02256982|E1|Reported Event|Resectable Disease|"Consent and Registration~3 cycles of gemcitabine + cisplatin~Evaluate for surgery* (weeks 10-15)~-- Patients who are eligible for surgery at restaging will receive surgery; patients not eligible for surgery at restaging will receive radiation therapy.~Proceed to surgery~Additional care as recommended; may include additional cycles of GEM + CDDP on a 21 day cycle and/or post-op radiation as recommended by treating medical oncologist and radiation oncologist~Gemcitabine~Cisplatin~Surgery: Surgical Resection and Lymphadenectomy"
647858|NCT02256969|B4|Baseline|Total|Total of all reporting groups
647859|NCT02256969|B3|Baseline|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
647860|NCT02256969|B2|Baseline|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647861|NCT02256969|B1|Baseline|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647862|NCT02256969|P3|Participant Flow|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
647863|NCT02256969|P2|Participant Flow|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647864|NCT02256969|P1|Participant Flow|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647865|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
647866|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647867|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647868|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
647869|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647870|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647871|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
647872|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647873|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647874|NCT02256969|O3|Outcome|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
647875|NCT02256969|O2|Outcome|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647876|NCT02256969|O1|Outcome|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647877|NCT02256969|E3|Reported Event|Meibomian Gland Probing Plus Blephamide|"Meibomian Gland Probing: Stainless steel probes were used to probe the meibomian glands of upper lids of both eyes. All patients were probed with a 1-mm probe followed by a 2-mm probe for all glands.~Blephamide: is a combination of an antibiotic and an anti-inflammatory agent commonly used to treat various ocular conditions. Blephamide was applied topically to both eyes for 4 weeks with a regimen of: twice daily for 2 weeks and then once daily for 2 weeks."
647878|NCT02256969|E2|Reported Event|Sham Meibomian Gland Probing Plus Lubricant|"Sham Meibomian Gland Probing: The patient's the lid margin was touched with the probes without actual probing occurring.~Lubricant: GenTeal PM Night-Time Ointment, ophthalmic lubricant used to relieve symptoms in patients with dry eye disease, was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647879|NCT02256969|E1|Reported Event|Meibomian Gland Probing Plus Lubricant|"Meibomian Gland Probing: Stainless steel probes were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp.~Lubricant: GenTeal PM Night-Time Ointment, an ophthalmic lubricant that is used to relieve symptoms in patients with dry eye disease; was applied topically to both eyes for 4 weeks: twice daily for 2 weeks and then once daily for 2 weeks."
647880|NCT02256553|B1|Baseline|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647881|NCT02256553|P1|Participant Flow|MK-3641+MK-7243|Participants receive one MK-7243 tablet, sublingually (SL) once a day (QD) in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647882|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647883|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647884|NCT02256553|O1|Outcome|MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647886|NCT02256553|E3|Reported Event|Period III: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647887|NCT02256553|E2|Reported Event|Period II: MK-3641+MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647888|NCT02256553|E1|Reported Event|Period I: MK-7243|Participants receive one MK-7243 tablet, SL QD in the evening for 14 days during Period I; one MK-3641 tablet, SL QD in the morning and one MK-7243 tablet, SL QD in the evening for 14 days during Period II; and one MK-3641 tablet, SL QD, and one MK-7243 tablet, SL QD, within 5 minutes of each other for 14 days during Period III.
647889|NCT02256488|B5|Baseline|Total|Total of all reporting groups
647890|NCT02256488|B4|Baseline|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
647891|NCT02256488|B3|Baseline|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
647892|NCT02256488|B2|Baseline|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
647893|NCT02256488|B1|Baseline|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
647894|NCT02256488|P4|Participant Flow|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
647895|NCT02256488|P3|Participant Flow|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
647896|NCT02256488|P2|Participant Flow|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
647897|NCT02256488|P1|Participant Flow|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
647898|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
647899|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
647900|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
647901|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
647902|NCT02256488|O2|Outcome|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf
647903|NCT02256488|O1|Outcome|TIVc (3 TIVc Lots Pooled)|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
647904|NCT02256488|O3|Outcome|TIVc_LOT C|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C
647905|NCT02256488|O2|Outcome|TIVc_LOT B|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B
647906|NCT02256488|O1|Outcome|TIVc_LOT A|Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A
647907|NCT02256488|E3|Reported Event|Total|Total number of subjects
647908|NCT02256488|E2|Reported Event|TIVf|Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf;
647909|NCT02256488|E1|Reported Event|TIVc Pooled|Subjects 18 to ≤ 49 years of age who received one vaccination of an investigational vaccine TIVc
647910|NCT02256358|B3|Baseline|Total|Total of all reporting groups
647911|NCT02256358|B2|Baseline|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
647912|NCT02256358|B1|Baseline|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
647913|NCT02256358|P2|Participant Flow|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
647914|NCT02256358|P1|Participant Flow|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
647915|NCT02256358|O2|Outcome|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
647916|NCT02256358|O1|Outcome|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
647917|NCT02256358|E2|Reported Event|Ketamine|"Intravenous 1 mg/kg ketamine was administered to the patients as premedication drug before entering operating room.~Ketamine: Preoperatively injected intravenous 1mg/kg ketamine"
647918|NCT02256358|E1|Reported Event|Midazolam|"Intravenous 0.1 mg/kg midazolam was administered to the patients as premedication drug before entering operating room.~Midazolam: preoperatively injected intravenous 0.1 mg/kg midazolam"
647919|NCT02256072|B3|Baseline|Total|Total of all reporting groups
647940|NCT02255565|P3|Participant Flow|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647941|NCT02255565|P2|Participant Flow|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647942|NCT02255565|P1|Participant Flow|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
648660|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
647920|NCT02256072|B2|Baseline|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647921|NCT02256072|B1|Baseline|Plan Your Lifespan Website|"Participants in the intervention arm will navigate Planyourlifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
647922|NCT02256072|P2|Participant Flow|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647923|NCT02256072|P1|Participant Flow|Plan Your Lifespan Website|Participants in the intervention arm will navigate PlanYourLifespan.org.
647924|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647925|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate the Plan Your Lifespan website, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas described below.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making."
647926|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647927|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
647928|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647929|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
647930|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647931|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
647932|NCT02256072|O2|Outcome|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647933|NCT02256072|O1|Outcome|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. The Plan Your Lifespan tool is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~Plan Your Lifespan Website: Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also inte"
647934|NCT02256072|E2|Reported Event|Go4Life Website|"Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. Our attention control group will control for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention website.~Go4Life Website: Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started)."
647935|NCT02256072|E1|Reported Event|Plan Your Lifespan Website|"Participants in the intervention arm will navigate PlanYourLifespan.org, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. PlanYourLifespan.org is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.~PlanYourLifespan.org: Participants in the intervention arm will navigate PlanYourLifespan.org, that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer’s, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website."
647936|NCT02255565|B4|Baseline|Total|Total of all reporting groups
647937|NCT02255565|B3|Baseline|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647938|NCT02255565|B2|Baseline|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647939|NCT02255565|B1|Baseline|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647943|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647944|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647945|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647946|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647947|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647948|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647949|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647950|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647951|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647952|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647953|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647954|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647955|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647956|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647957|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647958|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647959|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647960|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
648121|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
647999|NCT02255565|E1|Reported Event|Very Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks.~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647961|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647962|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647963|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647964|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647965|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647966|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647967|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647968|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647969|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647970|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647971|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647972|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647973|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647974|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647975|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647976|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647977|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647978|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647979|NCT02255565|O18|Outcome|Moderate Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647980|NCT02255565|O17|Outcome|Moderate Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647981|NCT02255565|O16|Outcome|Moderate Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647982|NCT02255565|O15|Outcome|Moderate Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647983|NCT02255565|O14|Outcome|Moderate Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647984|NCT02255565|O13|Outcome|Moderate Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647985|NCT02255565|O12|Outcome|Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647986|NCT02255565|O11|Outcome|Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647987|NCT02255565|O10|Outcome|Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647988|NCT02255565|O9|Outcome|Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647989|NCT02255565|O8|Outcome|Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647990|NCT02255565|O7|Outcome|Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
647991|NCT02255565|O6|Outcome|Very Low Dose Quillivant XR - Week 6|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647992|NCT02255565|O5|Outcome|Very Low Dose Quillivant XR - Week 5|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647993|NCT02255565|O4|Outcome|Very Low Dose Quillivant XR - Week 4|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647994|NCT02255565|O3|Outcome|Very Low Dose Quillivant XR - Week 3|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647995|NCT02255565|O2|Outcome|Very Low Dose Quillivant XR - Week 2|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647996|NCT02255565|O1|Outcome|Very Low Dose Quillivant XR - Week 1|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a very low dose level for 6 weeks. The dose titration was based on the physician's discretion and parent-reported Adverse Events (AE's).~Very Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 10mg dose"
647997|NCT02255565|E3|Reported Event|Moderate Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a moderate dose level for 6 weeks.~Moderate Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 40mg dose"
647998|NCT02255565|E2|Reported Event|Low Dose Quillivant XR|"Patients in this treatment arm are given Quillivant XR (a liquid medication) to treat ADHD at a low dose level for 6 weeks.~Low Dose Quillivant XR: Oral suspension dose once a day starting at 5mg and increasing to a 20mg dose"
648633|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648002|NCT02255279|B1|Baseline|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648003|NCT02255279|P2|Participant Flow|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648004|NCT02255279|P1|Participant Flow|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648005|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648006|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648007|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648008|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648009|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648010|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648011|NCT02255279|O2|Outcome|TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648012|NCT02255279|O1|Outcome|aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648013|NCT02255279|O2|Outcome|Non naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648014|NCT02255279|O1|Outcome|Non naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648015|NCT02255279|O2|Outcome|Naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648016|NCT02255279|O1|Outcome|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648017|NCT02255279|O2|Outcome|Non-naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648018|NCT02255279|O1|Outcome|Non-naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648019|NCT02255279|O2|Outcome|Naive_TIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered.
648020|NCT02255279|O1|Outcome|Naive_aTIV (≥36 Months to < 72 Months)|A 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered.
648021|NCT02255279|O2|Outcome|Non-naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
648022|NCT02255279|O1|Outcome|Non-naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
648023|NCT02255279|O2|Outcome|Naive_TIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of TIV to be administered.
648024|NCT02255279|O1|Outcome|Naive_aTIV (6 to <36 Months)|A 0.25 mL (for children 6 to <36 months old) dose of aTIV to be administered.
648025|NCT02255279|E4|Reported Event|Non-naive_TIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Non-naive).
648026|NCT02255279|E3|Reported Event|Non-naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Non-naive).
648027|NCT02255279|E2|Reported Event|Naive_TIV (6 Months to < 72 Months)|"A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV to be administered (Naive).~Enrolled subjects- 79 Exposed subjects- 78 Reason for discrepancy- Before vaccination one subject was withdrawn from study because of the suspected egg allergy."
648028|NCT02255279|E1|Reported Event|Naive_aTIV (6 Months to < 72 Months)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV to be administered (Naive).
648029|NCT02255149|B1|Baseline|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
648030|NCT02255149|P1|Participant Flow|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
648031|NCT02255149|O1|Outcome|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
648032|NCT02255149|E1|Reported Event|Bone/Mesh|"Allograft and Titanium mesh will be used to grow jaw bone vertically.~Bone/Mesh: A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow."
648056|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648057|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648058|NCT02254486|E2|Reported Event|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648059|NCT02254486|E1|Reported Event|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648033|NCT02254551|B1|Baseline|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
648034|NCT02254551|P1|Participant Flow|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
648035|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
648036|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg for 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
648037|NCT02254551|O1|Outcome|LDE225 Plus Bortezomib|"Safety Lead-In: To determine the maximum tolerated dose (MTD), LDE225 will be administered orally at three dose levels: 400mg, 600mg, and 800mg.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Expansion: Patients will receive LDE225 orally once daily for 21 days at the MTD. Bortezomib will be administered SQ at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity"
648038|NCT02254551|E3|Reported Event|Cohort 3: LDE225 800mg/m^2|"Cohort 3 will receive LDE225 orally on a daily basis, at 800mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
648039|NCT02254551|E2|Reported Event|Cohort 2: LDE225 600mg/m^2|Cohort 2 will receive LDE225 orally on a daily basis, at 600 mg every 21 days. Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle.
648040|NCT02254551|E1|Reported Event|Cohort 1: LDE225 400mg/m^2|"Cohort 1 will receive LDE225 orally on a daily basis, at 400mg/m^2 every 21 days.~Bortezomib will be administered by subcutaneous injection (SQ) at a fixed dose of 1.3 mg/m2 on days 1, 4, 8, and 11 of each 21 day cycle."
648041|NCT02254486|B3|Baseline|Total|Total of all reporting groups
648042|NCT02254486|B2|Baseline|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648043|NCT02254486|B1|Baseline|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648044|NCT02254486|P2|Participant Flow|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648045|NCT02254486|P1|Participant Flow|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648046|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648047|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648048|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648049|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648050|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648051|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648052|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648053|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648054|NCT02254486|O2|Outcome|NER1006 2-Day Split-Dosing|NER1006: NER1006 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
648055|NCT02254486|O1|Outcome|Trisulfate Solution 2-Day Split-Dosing|Trisulfate solution: Trisulfate solution 2-Day Split-Dosing Regimen (to commence in the evening of the day before the colonoscopy)
653883|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
648060|NCT02254460|B1|Baseline|Overall|Micronutrient fortified nutritional beverage powder (test) and energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
648061|NCT02254460|P2|Participant Flow|Control Follwed by Test|Patients first received energy, iron and calcium equivalent beverage powder without micronutrient fortification (control) and then micronutrient fortified nutritional beverage powder (test), packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
648062|NCT02254460|P1|Participant Flow|Test Followed by Control|Patients first received micronutrient fortified nutritional beverage powder (test) and then energy, iron and calcium equivalent beverage powder without micronutrient fortification (control), packed as 27 grams (g) individual sachets, administered as a single serve in a total volume of 100 milliliters (mL) lukewarm milk for oral consumption. 1mL solution containing 3 milligrams/milliliters (mg/mL) of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder. Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage
648063|NCT02254460|O2|Outcome|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption.1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
648064|NCT02254460|O1|Outcome|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
648065|NCT02254460|E2|Reported Event|Control|Energy, iron and calcium equivalent beverage powder without micronutrient fortification, packed as 27g individual sachets, administered as a single serve in a total volume of 100mL of lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe, 58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (control). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
648066|NCT02254460|E1|Reported Event|Test|Micronutrient fortified nutritional beverage powder, packed as 27g individual sachets, administered as a single serve in a total volume of 100 mL lukewarm milk for oral consumption. 1mL solution containing 3mg/mL of the stable iron isotope (57Fe,58Fe) was added to the graduated drinking container followed by a sachet of the study beverage powder (test). Lukewarm milk was added to the container to make up the volume to 100mL of reconstituted beverage.
648067|NCT02254252|B3|Baseline|Total|Total of all reporting groups
648068|NCT02254252|B2|Baseline|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
648069|NCT02254252|B1|Baseline|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
648070|NCT02254252|P2|Participant Flow|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
648071|NCT02254252|P1|Participant Flow|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
648072|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
648073|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
648074|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
648075|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
648117|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648076|NCT02254252|O2|Outcome|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
648122|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648123|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648077|NCT02254252|O1|Outcome|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
648078|NCT02254252|E2|Reported Event|Nicorandil|"nicorandil (10mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nicorandil: nicorandil (10mg tablets, two times a day)"
648079|NCT02254252|E1|Reported Event|Nitroglycerin|"sustained-release glyceryl trinitrate (6.4mg tablets, two times a day) + standard treatment (an anti-platelet agent, a beta-blocker, an angiotensin converting enzyme inhibitor, and a 3-hydroxy-3-methyl-glutaryl-CoA reductase inhibitor)~Nitroglycerin: sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)"
648080|NCT02253654|B3|Baseline|Total|Total of all reporting groups
648081|NCT02253654|B2|Baseline|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648082|NCT02253654|B1|Baseline|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648083|NCT02253654|P2|Participant Flow|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648084|NCT02253654|P1|Participant Flow|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648085|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648086|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648087|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648088|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648089|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648090|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648091|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648118|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648119|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
653884|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
648124|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648125|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648092|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648093|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648094|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648095|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648096|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648097|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648098|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648099|NCT02253654|O2|Outcome|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648100|NCT02253654|O1|Outcome|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648101|NCT02253654|E2|Reported Event|Epoetin Alfa USPI Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose decreases were permitted every 2 weeks and beginning at week 5 dose increases could only occur ≥ 4 weeks from the last dose increase, according to the United States package insert (USPI) dosing algorithm which includes four categories of hemoglobin levels.
648102|NCT02253654|E1|Reported Event|Epoetin Alfa Alternative Titration|Participants received epoetin alfa administered intravenously three times a week during hemodialysis for up to 37 weeks. For the first two weeks the dose of epoetin alfa was based on the dose at the time of screening. Beginning at week 3 dose changes may have occurred every 2 weeks according to the alternative dosing algorithm, where smaller, frequent dose adjustments were permitted based on six hemoglobin categories.
648103|NCT02253173|B5|Baseline|Total|Total of all reporting groups
648104|NCT02253173|B4|Baseline|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648105|NCT02253173|B3|Baseline|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648106|NCT02253173|B2|Baseline|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648107|NCT02253173|B1|Baseline|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648108|NCT02253173|P4|Participant Flow|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648109|NCT02253173|P3|Participant Flow|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648110|NCT02253173|P2|Participant Flow|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648111|NCT02253173|P1|Participant Flow|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648112|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648113|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648114|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648115|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648116|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648126|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648127|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648128|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648129|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648130|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648131|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648132|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648133|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648134|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648135|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648136|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648137|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648138|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648139|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648140|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648141|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648142|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648143|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648144|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648145|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648146|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648147|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648148|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648149|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648150|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648151|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648152|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648153|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648154|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648155|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648156|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648157|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648158|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648159|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648160|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648161|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648162|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648163|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648164|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648165|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648166|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648167|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648168|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648169|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648170|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648171|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648172|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648173|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648174|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648175|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648176|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648177|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
653885|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
648178|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648179|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648180|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648181|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648182|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648183|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648184|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648185|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648186|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648187|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648188|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648189|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648190|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648191|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648192|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648193|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648194|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648195|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648196|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648197|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648198|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648199|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648200|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648201|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648202|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648203|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648204|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648205|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648206|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648207|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648208|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648209|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648210|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648211|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648212|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648213|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648214|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648215|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648216|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648217|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648218|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648219|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648220|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648221|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648222|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648223|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648224|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648225|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648226|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648227|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648228|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648229|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648230|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648231|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648232|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648233|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
653886|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
648234|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648235|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648236|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648237|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648238|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648239|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648240|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648241|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648242|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648243|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648244|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648245|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648246|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648247|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648248|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648249|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648250|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648251|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648252|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648253|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648254|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648255|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648256|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648257|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648258|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648259|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648260|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648261|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648262|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648263|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648264|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648265|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648266|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648267|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648268|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648269|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648270|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648271|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648272|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648273|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648274|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648275|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648276|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648277|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648278|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648279|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648280|NCT02253173|O4|Outcome|Placebo Vaginal Softgel Capsule|"Placebo Vaginal Softgel Capsule~Placebo"
648281|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|"Estradiol 25mcg Vaginal Softgel Capsule~Estradiol"
648282|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|"Estradiol 10mcg Vaginal Softgel Capsule~Estradiol"
648283|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|"Estradiol 4mcg Vaginal Softgel Capsule~Estradiol"
648284|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648285|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648286|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648287|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648634|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648288|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648289|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648290|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648291|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648292|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648293|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648294|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648295|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648296|NCT02253173|O4|Outcome|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648297|NCT02253173|O3|Outcome|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648298|NCT02253173|O2|Outcome|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648299|NCT02253173|O1|Outcome|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648300|NCT02253173|E4|Reported Event|Placebo|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648301|NCT02253173|E3|Reported Event|Estradiol 25mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648302|NCT02253173|E2|Reported Event|Estradiol 10mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648303|NCT02253173|E1|Reported Event|Estradiol 4mcg Vaginal Softgel Capsule|Postmenopausal women self-administered intravaginally one capsule daily for 14 days and then bi-weekly for 10 weeks.
648304|NCT02253160|B4|Baseline|Total|Total of all reporting groups
648305|NCT02253160|B3|Baseline|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648306|NCT02253160|B2|Baseline|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648307|NCT02253160|B1|Baseline|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
648308|NCT02253160|P3|Participant Flow|COBE Spectra MNC First, Then Spectra Optia CMNC|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648309|NCT02253160|P2|Participant Flow|Spectra Optia CMNC First, Then COBE Spectra MNC|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648310|NCT02253160|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
648379|NCT02252718|B1|Baseline|Children 2-18 Months of Age|Children between 2 and 18 months of age who were not toilet trained
648354|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648420|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
654468|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
648311|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648312|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648313|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648314|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648315|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648316|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648317|NCT02253160|O2|Outcome|COBE Spectra|Subjects who received an CMNC collection using the COBE Spectra
648318|NCT02253160|O1|Outcome|Spectra Optia|Subjects who received an CMNC collection using the Spectra Optia
648319|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648352|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648353|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648320|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648321|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648322|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648323|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648324|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648325|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648326|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648327|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648328|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648329|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648330|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648331|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648332|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648333|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648334|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648335|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648336|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648337|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648338|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648339|NCT02253160|O2|Outcome|Treatment Assignment 2|"COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648340|NCT02253160|O1|Outcome|Treatment Assignment 1|"Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure.~Spectra Optia CMNC: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.~COBE Spectra MNC: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled."
648341|NCT02253160|E4|Reported Event|Follow up|Subjects who completed cross-over design and were followed for at least 1 day.
648342|NCT02253160|E3|Reported Event|COBE Spectra|Subjects who received COBE Spectra MNC collection procedure.
648343|NCT02253160|E2|Reported Event|Spectra Optia|Subject who received Spectra Optia CMNC collection procedure.
648344|NCT02253160|E1|Reported Event|Pre-collection|Subjects screened and received G-CSF.
648345|NCT02252965|B3|Baseline|Total|Total of all reporting groups
648346|NCT02252965|B2|Baseline|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648347|NCT02252965|B1|Baseline|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648348|NCT02252965|P2|Participant Flow|Metformin XR|Subjects received Metformin Extended Release (XR) tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648349|NCT02252965|P1|Participant Flow|Metformin IR|Subjects received Metformin Immediate Release (IR) tablets, orally once daily (QD) at a dose of 500 milligram (mg) for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648350|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648351|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648355|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648356|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648357|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648358|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648359|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648360|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648361|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648362|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
648363|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648364|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648365|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648366|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16
648367|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648368|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648369|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648370|NCT02252965|O2|Outcome|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648371|NCT02252965|O1|Outcome|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648372|NCT02252965|E3|Reported Event|Metformin IR to XR|Subjects who received Metformin IR tablets initially, but were shifted to Metformin XR group due to intolerance to Metformin IR.
648373|NCT02252965|E2|Reported Event|Metformin XR|Subjects received Metformin XR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for next 2 weeks and maintained at 2000 mg until Week 16.
648374|NCT02252965|E1|Reported Event|Metformin IR|Subjects received Metformin IR tablets, orally QD at a dose of 500 mg for 1 week, and then the dose was increased with increments of 500 mg every week in the first 2 weeks to 1500 mg. After that, the dose was increased up to a maximum dose of 2000 mg for the next two weeks and maintained at 2000 mg until Week 16.
648375|NCT02252744|B1|Baseline|RA Patients|Adult patients diagnosed with rheumatoid arthritis
653887|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
648417|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648418|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648419|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648380|NCT02252718|P1|Participant Flow|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
648381|NCT02252718|O1|Outcome|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
648382|NCT02252718|E1|Reported Event|Children 2-18 Months of Age|"Children aged between 2 and 18 months of age, who were not toilet trained, admitted to the Department of Pediatrics The Medical University of Warsaw~Stool Assessment: After passing a stool by the child participating in the study, within the shortest possible time (<5 min), the stool will be assessed independently and simulataneously by one of the parents and the medical doctor. They were unaware of the evaluation results made by the other. At the same time 2 photos were taken with smartphone camera. Then the photographs were subsequently evaluated by the other physician (MD2), who was unaware of the in vivo stool evaluation."
648383|NCT02252445|B3|Baseline|Total|Total of all reporting groups
648384|NCT02252445|B2|Baseline|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648385|NCT02252445|B1|Baseline|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648386|NCT02252445|P2|Participant Flow|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648387|NCT02252445|P1|Participant Flow|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648388|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648389|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648390|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648391|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648392|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648393|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648394|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648395|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648396|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648397|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648398|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648399|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648400|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648401|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648402|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648403|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648404|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648405|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648406|NCT02252445|O2|Outcome|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648407|NCT02252445|O1|Outcome|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648408|NCT02252445|E2|Reported Event|Sevoflurane|"Sevoflurane will be administered as the anesthetic maintenance agent.~Sevoflurane: Sevoflurane will be administered."
648409|NCT02252445|E1|Reported Event|Propofol|"Propofol will be administered as the anesthetic maintenance agent.~Propofol: Propofol will be administered."
648410|NCT02252354|B3|Baseline|Total|Total of all reporting groups
648411|NCT02252354|B2|Baseline|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648412|NCT02252354|B1|Baseline|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648413|NCT02252354|P2|Participant Flow|Part 2: TAK-385 + [14C]-TAK-385|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648414|NCT02252354|P1|Participant Flow|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648415|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648416|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648421|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648422|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648423|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648424|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648425|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648426|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648427|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648428|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648429|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648430|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648431|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648432|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648433|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648434|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648435|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648436|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648437|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648438|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648439|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648440|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648441|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648442|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648443|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648444|NCT02252354|O1|Outcome|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648445|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648446|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648447|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648448|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648449|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648450|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648451|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648452|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648453|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648454|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648455|NCT02252354|O1|Outcome|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648456|NCT02252354|E2|Reported Event|Part 2: TAK-385 + [14C]-TAK-385 IV|TAK-385 80 mg, tablets, orally, and [14C]-TAK-385 80 mcg, infusion, intravenous single dose on Day 1.
648457|NCT02252354|E1|Reported Event|Part 1: [14C]-TAK-385|[14C]-TAK-385 80 mg, solution, orally, single dose on Day 1.
648458|NCT02252133|B1|Baseline|Overall|DAILIES TOTAL1® and 1-Day Acuvue® TruEye® contact lenses worn during Period 1 and Period 2 in a crossover assignment.
648459|NCT02252133|P2|Participant Flow|1DAVTE, Then DT1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
648460|NCT02252133|P1|Participant Flow|DT1, Then 1DAVTE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product worn bilaterally for 7 days on a daily wear, daily disposable basis.
648461|NCT02252133|O2|Outcome|1DAVTE|Narafilcon A contact lenses worn during Period 1 or Period 2 for 7 days.
648462|NCT02252133|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses during Period 1 or Period 2 for 7 days.
648463|NCT02252133|E2|Reported Event|1DAVTE|All subjects who wore narafilcon A contact lenses
648464|NCT02252133|E1|Reported Event|Dailies Total 1|All subjects who wore delefilcon A contact lenses
648465|NCT02252016|B3|Baseline|Total|Total of all reporting groups
648635|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648636|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648466|NCT02252016|B2|Baseline|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
648497|NCT02251652|B1|Baseline|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
648467|NCT02252016|B1|Baseline|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
648468|NCT02252016|P2|Participant Flow|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
648469|NCT02252016|P1|Participant Flow|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
648470|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
648471|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
648472|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
648473|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
648474|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
648475|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
648476|NCT02252016|O2|Outcome|Deferred Treatment|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
648477|NCT02252016|O1|Outcome|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
648478|NCT02252016|E2|Reported Event|Deferred Treatment: Placebo Phase|Participants took placebo tablets q.d. during the initial 12-week treatment period, and then underwent a 4-week safety monitoring follow-up period. Next, participants took open-label grazoprevir 100 mg + elbasvir 50 mg q.d. for 12 weeks, followed by a 24-week safety monitoring period.
648479|NCT02252016|E1|Reported Event|Immediate Treatment|Participants took grazoprevir 100 mg + elbasvir 50 mg once daily (q.d.) during the initial 12-week treatment period, followed by a 24-week safety monitoring period.
648480|NCT02251886|B5|Baseline|Total|Total of all reporting groups
648481|NCT02251886|B4|Baseline|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
648482|NCT02251886|B3|Baseline|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
648483|NCT02251886|B2|Baseline|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
648484|NCT02251886|B1|Baseline|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
648485|NCT02251886|P4|Participant Flow|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
648486|NCT02251886|P3|Participant Flow|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
648487|NCT02251886|P2|Participant Flow|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
648488|NCT02251886|P1|Participant Flow|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
648489|NCT02251886|O4|Outcome|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
648490|NCT02251886|O3|Outcome|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
648491|NCT02251886|O2|Outcome|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
648492|NCT02251886|O1|Outcome|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
648493|NCT02251886|E4|Reported Event|Control Multiparae|No intervention. Routine control schedule for multiparae with midwife
648494|NCT02251886|E3|Reported Event|Control Primiparae|No intervention. Routine control schedule for primiparae with midwife
648495|NCT02251886|E2|Reported Event|Moxibustion in Multiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in multiparae~Moxibustion in multiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
648637|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648638|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648496|NCT02251886|E1|Reported Event|Moxibustion in Primiparae|"Moxibustion added to the acupuncture point Bl 67 for 15-20 minutes daily from week 32 to 36 in primiparae~Moxibustion in primiparae: Moxibustion at acupuncture point Bl 67 daily for 15-20 minutes for 3-4 weeks in multiparae"
654469|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
648498|NCT02251652|P1|Participant Flow|Actinic Keratosis|Each subject is its own control - left dorsal hand compared to right dorsal hand
648499|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648500|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648501|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648502|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648503|NCT02251652|O2|Outcome|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648504|NCT02251652|O1|Outcome|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648505|NCT02251652|E2|Reported Event|Cryotherapy Alone|"Cryotherapy only~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648506|NCT02251652|E1|Reported Event|Combination Therapy|"Cryotherapy followed by Ingenol Mebutate Gel~Ingenol Mebutate: Ingenol mebutate 0.05% gel~Cryotherapy: 1-2 sprays, 5 seconds each, with a 5 second interval"
648507|NCT02251613|B1|Baseline|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
648508|NCT02251613|P1|Participant Flow|Overall|Olopatadine HCl ophthalmic solution, 0.1%, and Epinastine HCl ophthalmic solution, 0.05%, administered contralaterally (1 drop in each eye), as randomized
648509|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
648510|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
648511|NCT02251613|O2|Outcome|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
648512|NCT02251613|O1|Outcome|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
648513|NCT02251613|E2|Reported Event|Epinastine 0.05%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
648514|NCT02251613|E1|Reported Event|Olopatadine 0.1%|Ophthalmic solution, 1 drop instilled in 1 eye, as randomized.
648515|NCT02251561|B1|Baseline|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
648516|NCT02251561|P1|Participant Flow|FID 109182/Opti-Free Plus|Senofilcon A contact lens pre-soaked in FID 109182 in 1 eye, with senofilcon A contact lens pre-soaked in Opti-Free Plus in the fellow eye. Lenses worn contralaterally for 2 hours.
648517|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
648518|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
648519|NCT02251561|O2|Outcome|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
648520|NCT02251561|O1|Outcome|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
648521|NCT02251561|E2|Reported Event|Opti-Free Plus|Senofilcon A contact lens pre-soaked in Opti-Free Plus worn in 1 eye for 2 hours
648522|NCT02251561|E1|Reported Event|FID 109182|Senofilcon A contact lens pre-soaked in FID 109182 worn in 1 eye for 2 hours
648523|NCT02250807|B1|Baseline|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648524|NCT02250807|P1|Participant Flow|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648525|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648526|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648527|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648528|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648529|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648530|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648531|NCT02250807|O1|Outcome|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648532|NCT02250807|E1|Reported Event|SMV+SOF 12 Weeks|Participants received oral capsule of simeprevir (SMV) 150 milligram (mg) and an oral tablet of sofosbuvir (SOF) 400 mg, once a day from Day 1 through Week 12.
648533|NCT02250274|B3|Baseline|Total|Total of all reporting groups
648561|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648639|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648563|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648534|NCT02250274|B2|Baseline|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
648535|NCT02250274|B1|Baseline|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
648536|NCT02250274|P2|Participant Flow|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
648537|NCT02250274|P1|Participant Flow|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
648538|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
648539|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
648540|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
648541|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
648542|NCT02250274|O2|Outcome|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
648543|NCT02250274|O1|Outcome|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
648562|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648640|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648641|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648544|NCT02250274|E2|Reported Event|IIV 2014-15|"Will receive IIV this year. Includes only 9-17 year olds (unless shortages of LAIV encountered). Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, only 9-17 year olds.~IIV: A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
648545|NCT02250274|E1|Reported Event|LAIV 2014-15|"Will receive LAIV this year. Includes 5-8 year olds and approximately half of the 9-17 year olds. Prior history includes vaccine failures, vaccinated/uninfected and unvaccinated/uninfected last year. PBMC available for those who were infected last year, all ages.~LAIV: Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV."
648546|NCT02249728|B1|Baseline|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
648547|NCT02249728|P1|Participant Flow|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648548|NCT02249728|O1|Outcome|Part Two Radiolabelle AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648549|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648550|NCT02249728|O1|Outcome|All Study Participants|In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Following completion of Part One, participants crossed over into Part Two (Radiolabelled AME), where a single dose of oral PBT2 250 mg 14C suspension was administered.
648551|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648552|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648553|NCT02249728|O1|Outcome|Part Two Radiolabelled AME|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648554|NCT02249728|O1|Outcome|Part One Absolute Bioavailability|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648555|NCT02249728|E1|Reported Event|All Study Participants|"In Part One (Absolute Bioavailability), a single dose of oral PBT2 250 mg capsule administered followed by IV PBT2 microtracer. Participants then proceed into Part Two.~In Part Two (Radiolabelled AME), a single dose of oral PBT2 250mg 14C suspension administered"
648556|NCT02249104|B1|Baseline|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648557|NCT02249104|P1|Participant Flow|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648558|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648559|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648560|NCT02249104|O1|Outcome|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648623|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648624|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648625|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648626|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648564|NCT02249104|E1|Reported Event|Acne Treatment|"Adapalene/benzoyl peroxide gel, 0.1%/2.5%, once daily~Cetaphil Acne Regimen:~Cetaphil® DermaControl™ Moisturizer SPF 30, once daily and additionally 15 minutes prior to participation in outdoor sports if more than 2 hours elapsed since morning application~Cetaphil® DermaControl™ Foam Wash, at least twice daily~Adapalene/benzoyl peroxide gel, 0.1%/2.5%: Topical AV therapy~Cetaphil Acne Regimen: Cleanse, Moisturize, and Protect"
648565|NCT02249052|B1|Baseline|AA4500 and Placebo|"single injection of 0.58 mg study drug and placebo~Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
648566|NCT02249052|P1|Participant Flow|AA4500 and Placebo|"Each subject received a single injection of 1 mL containing 0.58 mg AA4500 in one lipoma and a single injection of 1 mL placebo in another lipoma~Lipoma #1 was randomized to AA4500 or placebo with Lipoma #2 receiving the alternate intervention"
648567|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
648568|NCT02249052|O1|Outcome|AA4500|Each participants received a single injection of 1 mL containing 0.58 mg AA4500
648569|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
648570|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
648571|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
648572|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
648573|NCT02249052|O2|Outcome|Placebo|Each participant received a single injection of 1 mL placebo
648574|NCT02249052|O1|Outcome|AA4500|Each participants received a single injection of 1 mL containing 0.58 mg AA4500
648575|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
648576|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
648577|NCT02249052|O2|Outcome|Placebo|Each subject received a single injection of 1 mL placebo
648578|NCT02249052|O1|Outcome|AA4500|Each subject received a single injection of 1 mL containing 0.58 mg AA4500
648579|NCT02249052|E2|Reported Event|Placebo|"single injection of placebo~placebo: Placebo"
648580|NCT02249052|E1|Reported Event|AA4500|"single injection of 0.58 mg study drug~AA4500: Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously"
648581|NCT02248818|B9|Baseline|Total|Total of all reporting groups
648582|NCT02248818|B8|Baseline|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648583|NCT02248818|B7|Baseline|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648584|NCT02248818|B6|Baseline|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648585|NCT02248818|B5|Baseline|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648586|NCT02248818|B4|Baseline|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648587|NCT02248818|B3|Baseline|AZD8108 95 mg - SAD|AZD8108 95 mg SAD, Cohort 3
648588|NCT02248818|B2|Baseline|AZD8108 60 mg - SAD|AZD8108 60 mg SAD, Cohort 2
648589|NCT02248818|B1|Baseline|AZD8108 20 mg - SAD|AZD8108 20 mg SAD, Cohort 1
648590|NCT02248818|P9|Participant Flow|Screen|Screen - no treatment
648591|NCT02248818|P8|Participant Flow|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648592|NCT02248818|P7|Participant Flow|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648593|NCT02248818|P6|Participant Flow|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648594|NCT02248818|P5|Participant Flow|AZD8108 50 mg|AZD8108 50 mg MAD, Cohort 5
648595|NCT02248818|P4|Participant Flow|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648596|NCT02248818|P3|Participant Flow|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648597|NCT02248818|P2|Participant Flow|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648598|NCT02248818|P1|Participant Flow|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648599|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648600|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648601|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648602|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648603|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648604|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648605|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648606|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648607|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648608|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648609|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648610|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648611|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648612|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648613|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648614|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648615|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648616|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648617|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648618|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648619|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648620|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648621|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648622|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648642|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648643|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648644|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648645|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
654470|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
648661|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648662|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648663|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648664|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648665|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648666|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648667|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648668|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648669|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648670|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648671|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648672|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648673|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648674|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648675|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648676|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648677|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648678|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648679|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648680|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648681|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648682|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648683|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648684|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648685|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648686|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648687|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648688|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648689|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648690|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648691|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648692|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648693|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648694|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648695|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648696|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648697|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648698|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648699|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648700|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648701|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648702|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648703|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648704|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648705|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648706|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648707|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648708|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648709|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648710|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648711|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648712|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648713|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648714|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648715|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648716|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648717|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648718|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648719|NCT02248818|O8|Outcome|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648720|NCT02248818|O7|Outcome|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648721|NCT02248818|O6|Outcome|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648722|NCT02248818|O5|Outcome|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648723|NCT02248818|O4|Outcome|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648724|NCT02248818|O3|Outcome|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648725|NCT02248818|O2|Outcome|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648726|NCT02248818|O1|Outcome|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648727|NCT02248818|E8|Reported Event|Placebo MAD|Placebo MAD, pooled across Cohorts 5 & 7
648728|NCT02248818|E7|Reported Event|AZD8108 90 mg MAD (7)|AZD8108 90 mg MAD, Cohort 7
648729|NCT02248818|E6|Reported Event|AZD8108 90 mg MAD (6)|AZD8108 90 mg MAD, Cohort 6
648730|NCT02248818|E5|Reported Event|AZD8108 50 mg MAD|AZD8108 50 mg MAD, Cohort 5
648731|NCT02248818|E4|Reported Event|Placebo SAD|Placebo SAD, pooled across Cohorts 1 - 3
648732|NCT02248818|E3|Reported Event|AZD8108 95 mg SAD|AZD8108 95 mg SAD, Cohort 3
648733|NCT02248818|E2|Reported Event|AZD8108 60 mg SAD|AZD8106 60 mg SAD, Cohort 2
648734|NCT02248818|E1|Reported Event|AZD8108 20 mg SAD|AZD8108 20 mg SAD, Cohort 1
648787|NCT02248480|B2|Baseline|Placebo|Placebo administered orally once a day for 15 weeks.
648735|NCT02248766|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
648736|NCT02248766|P1|Participant Flow|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
648737|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648738|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648739|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648740|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
648741|NCT02248766|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648742|NCT02248766|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648743|NCT02248766|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648744|NCT02248766|O1|Outcome|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
648745|NCT02248766|E2|Reported Event|Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
648746|NCT02248766|E1|Reported Event|Enfilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~enfilcon A: All participants wear habitual enfilcon A lens first and then refitted with somofilcon A lens"
648747|NCT02248727|B1|Baseline|Enfilcon A / Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
648748|NCT02248727|P1|Participant Flow|Enfilcon A / Somofilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648749|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648750|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648751|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648752|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648753|NCT02248727|O4|Outcome|Somofilcon A at 4 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648754|NCT02248727|O3|Outcome|Somofilcon A at 2 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648755|NCT02248727|O2|Outcome|Somofilcon A at 1 Week|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648756|NCT02248727|O1|Outcome|Enfilcon A|All participants are habitual wearers of enfilcon A lenses and who are then refitted with somofilcon A lenses.
648757|NCT02248727|E1|Reported Event|Enfilcon A to Somofilcon A|"All participants are habitual wearers of enfilcon A lens and who are refitted with somofilcon A lens~somofilcon A: All participants wear habitual enfilcon A lens first then refitted with somofilcon A lens"
648758|NCT02248675|B3|Baseline|Total|Total of all reporting groups
648780|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
648981|NCT02244580|O1|Outcome|Luminal A|Patients subtyped as Luminal A with DDFS determined 5 years after randomisation
648759|NCT02248675|B2|Baseline|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648760|NCT02248675|B1|Baseline|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648995|NCT02243943|E1|Reported Event|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
648761|NCT02248675|P2|Participant Flow|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648762|NCT02248675|P1|Participant Flow|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648763|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648764|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648765|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648766|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648781|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
648820|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648821|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648767|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648768|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648769|NCT02248675|O2|Outcome|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648770|NCT02248675|O1|Outcome|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648771|NCT02248675|E2|Reported Event|TAU Control|"Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648772|NCT02248675|E1|Reported Event|CBT-I + TAU|"Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions as an adjunctive treatment to treatment as usual (TAU).~CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.~TAU: Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments."
648773|NCT02248558|B3|Baseline|Total|Total of all reporting groups
648774|NCT02248558|B2|Baseline|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
648775|NCT02248558|B1|Baseline|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
648776|NCT02248558|P2|Participant Flow|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
648777|NCT02248558|P1|Participant Flow|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
648778|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.~In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
648779|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.~111 of 317 (35%) in the health marketing arm reported testing for HIV"
648782|NCT02248558|O2|Outcome|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.~In the crowdsourced intervention arm, 114 of 307 (37%) reported testing for HIV."
648783|NCT02248558|O1|Outcome|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.~111 of 317 (35%) in the health marketing arm reported testing for HIV"
648784|NCT02248558|E2|Reported Event|Crowdsourced Video|"This arm will receive a one-minute crowdsourced video promoting HIV test uptake.~Crowdsourced Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos."
648785|NCT02248558|E1|Reported Event|Conventional Video|"This arm will receive a one-minute conventional video promoting HIV test uptake.~Conventional Video: Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development."
648786|NCT02248480|B3|Baseline|Total|Total of all reporting groups
648788|NCT02248480|B1|Baseline|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648789|NCT02248480|P2|Participant Flow|Placebo|Placebo administered orally once a day for 15 weeks.
648790|NCT02248480|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648791|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648792|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648793|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648794|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648795|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648796|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648797|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648798|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648799|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648800|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648801|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648802|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648803|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648804|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648805|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648806|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648807|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648808|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648809|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648810|NCT02248480|O1|Outcome|Duloxetine|"Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.~Duloxetine: Administered orally"
648811|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648812|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648813|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648814|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648815|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648816|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648817|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648818|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648819|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648822|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648823|NCT02248480|O2|Outcome|Placebo|Placebo administered orally once a day for 15 weeks.
648824|NCT02248480|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648825|NCT02248480|E2|Reported Event|Placebo|Placebo administered orally once a day for 15 weeks.
648826|NCT02248480|E1|Reported Event|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered orally once daily. Tapering week doses of 40 mg for three days and 20 mg for four days.
648827|NCT02248246|B1|Baseline|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
648828|NCT02248246|P1|Participant Flow|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
648996|NCT02243280|B12|Baseline|Total|Total of all reporting groups
648829|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
648830|NCT02248246|O1|Outcome|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
648831|NCT02248246|E1|Reported Event|Colectomy With Harmonic ACE®+7 Shears|"Laparoscopic colectomy with Harmonic ACE®+7 Shears for dissection and vessel transection~Harmonic ACE®+7 Shears: Vessel sealing performance assessed for transection and sealing of the following named vessels:~Inferior mesenteric artery (IMA)~Inferior mesenteric vein (IMV) (if identified)"
648832|NCT02248103|B3|Baseline|Total|Total of all reporting groups
648833|NCT02248103|B2|Baseline|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
648834|NCT02248103|B1|Baseline|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
648835|NCT02248103|P2|Participant Flow|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
648836|NCT02248103|P1|Participant Flow|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
648837|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
648838|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
648839|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
648840|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
648841|NCT02248103|O2|Outcome|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
648842|NCT02248103|O1|Outcome|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
648843|NCT02248103|E2|Reported Event|Bioresorbable Collagen Membrane|"Equine Achilles tendon collagen barrier membrane~Bioresorbable collagen membrane: Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration"
648844|NCT02248103|E1|Reported Event|Periosteal Pedicle Graft|"autogenous marginal periosteal pedicle graft harvested by partial thickness periodontal flap.~Periosteal pedicle graft: Autogenous pedicle graft harvested from the periosteum"
648845|NCT02247960|B3|Baseline|Total|Total of all reporting groups
648846|NCT02247960|B2|Baseline|No Antibiotic|No Antibiotic
648847|NCT02247960|B1|Baseline|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
648848|NCT02247960|P2|Participant Flow|No Antibiotic|No Antibiotic
648849|NCT02247960|P1|Participant Flow|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
648850|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
648851|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
648852|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
648853|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
648854|NCT02247960|O2|Outcome|No Antibiotic|No Antibiotic
648855|NCT02247960|O1|Outcome|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
648856|NCT02247960|E2|Reported Event|No Antibiotic|No Antibiotic
648857|NCT02247960|E1|Reported Event|Ciprofloxacin|"Antibiotic~Ciprofloxacin"
648858|NCT02247765|B1|Baseline|no Treatment|
648917|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648918|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648859|NCT02247765|P1|Participant Flow|USB Pulse Oximetry Monitor Interface Cable|"Additional interventions include the following: Radial Arterial Line placement involves introduction of a standard arterial catheter or angiocath into the radial artery. Since the arterial catheter is placed into the artery using a needle, there will be mild to moderate discomfort. The total amount of blood drawn during the procedure is less than 100cc.~Additionally, subjects are asked to perform motions with their hand. Standard motions include tapping and rubbing at aperiodic intervals with amplitudes of 1‐2 cm and 1‐4 Hz with a random variation in frequency. The subject is instructed to tap (or rub) with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are recorded by the pressure pad system. Each plateau will have both an interval of tapping and rubbing."
648860|NCT02247765|O1|Outcome|no Treatment|
648861|NCT02247765|O1|Outcome|no Treatment|
648862|NCT02247765|E1|Reported Event|no Treatment|
648863|NCT02247011|B3|Baseline|Total|Total of all reporting groups
648864|NCT02247011|B2|Baseline|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648997|NCT02243280|B11|Baseline|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
648865|NCT02247011|B1|Baseline|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648866|NCT02247011|P1|Participant Flow|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants.
648867|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648868|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648869|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648870|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648871|NCT02247011|O2|Outcome|Non-fracture Group|Fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648872|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648873|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648874|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648875|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648876|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648877|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648878|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648879|NCT02247011|O2|Outcome|Non-fracture Group|Non-fracture Group included participants without new fractures during the 5 year follow-up visit. Fracture consists of vertebral fracture and non-vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648880|NCT02247011|O1|Outcome|Fracture Group|Fracture group included participants with new fractures during the 5 year follow-up visit. Fracture consists of non-vertebral fracture and vertebral fracture, which were investigated by questionnaire survey and lateral radiographs, respectively.
648881|NCT02247011|E1|Reported Event|Overall Subjects|In 2007-2008, 2070 postmenopausal women participated in the previous PK-VF study. After 5 years, 1100 subjects agreed to be re-evaluated in 2013. Questionnaires and blood samples were collected, and BMD and spine x-ray were obtained from these 1100 participants. Of all these participants, 975 participants finished the questionnaire and for 961 of them, the spine x-ray was of enough quality to determine if there is vertebral fracture.
648882|NCT02246582|B1|Baseline|All Subjects|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
648979|NCT02244580|O1|Outcome|Patients With MKI67 mRNA Determination|Patients with low MKI67 mRNA
648883|NCT02246582|P2|Participant Flow|Group B (FST 14 Hrs After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
648884|NCT02246582|P1|Participant Flow|Group A (FST 30 Mins After Sensor Insertion)|"Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
648885|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
648925|NCT02246166|E1|Reported Event|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648926|NCT02246114|B3|Baseline|Total|Total of all reporting groups
648886|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
648887|NCT02246582|O1|Outcome|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
648888|NCT02246582|E1|Reported Event|Group|"Subjects will be randomly assigned to 2 groups (Group A & Group B) that will determine when they will be participating in the in-clinic YSI frequent sample testing.~Enlite 3: Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.~Guardian Mobile App~640G Insulin Pump"
648889|NCT02246166|B3|Baseline|Total|Total of all reporting groups
648890|NCT02246166|B2|Baseline|Placebo|Matching placebo tablet
648891|NCT02246166|B1|Baseline|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648892|NCT02246166|P2|Participant Flow|Placebo|Matching placebo tablet
648893|NCT02246166|P1|Participant Flow|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648894|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648895|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648896|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648897|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648898|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648899|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648900|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648901|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648902|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648903|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648904|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648905|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648906|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648907|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648908|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648909|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648910|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648911|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648912|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648913|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648914|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648915|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648916|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648919|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648920|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648921|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648922|NCT02246166|O2|Outcome|Placebo|Matching placebo tablet
648923|NCT02246166|O1|Outcome|Test Tablet|Tablet containing Paracetamol, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide and Chlorpheniramine Maleate Tablets (II) (Paracetamol 500mg, pseudoephedrine 30mg, chlorpheniramine 2mg and dextromethorphan 15mg).
648924|NCT02246166|E2|Reported Event|Placebo|Matching placebo tablet
648927|NCT02246114|B2|Baseline|Arm B|CO monitor
648936|NCT02246062|B4|Baseline|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
648937|NCT02246062|B3|Baseline|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
648938|NCT02246062|B2|Baseline|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
648939|NCT02246062|B1|Baseline|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
648940|NCT02246062|P4|Participant Flow|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
648941|NCT02246062|P3|Participant Flow|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
648942|NCT02246062|P2|Participant Flow|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
648943|NCT02246062|P1|Participant Flow|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
648944|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
648945|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
648946|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
648947|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
648948|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
648949|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
648980|NCT02244580|O2|Outcome|Combined Subtype|Patients subtyped as Luminal B, HER2 positive, triple negative with DDFS determined 5 years after randomisation
653888|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
648950|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
648951|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
648952|NCT02246062|O4|Outcome|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
648953|NCT02246062|O3|Outcome|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
648954|NCT02246062|O2|Outcome|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
648955|NCT02246062|O1|Outcome|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
648998|NCT02243280|B10|Baseline|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
648956|NCT02246062|E4|Reported Event|Smartphone and Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery and the child received smartphone application immediately before entering the operating room.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.~smartphone: the child received smartphone application immediately before entering the operating room"
648957|NCT02246062|E3|Reported Event|Smartphone Group|"in which the relative received only conventional verbal information one day before the procedure and the child received smartphone application immediately before entering the operating room~smartphone: the child received smartphone application immediately before entering the operating room"
648958|NCT02246062|E2|Reported Event|Info Group|"in which the relative, in addition to conventional verbal information, received a leaflet containing information about the anesthetic procedure one day before the surgery at ward.~info: the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward."
648959|NCT02246062|E1|Reported Event|Control Group|in which the relative receive only conventional verbal information one day before the procedure at ward.
648960|NCT02245360|B3|Baseline|Total|Total of all reporting groups
648961|NCT02245360|B2|Baseline|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
648962|NCT02245360|B1|Baseline|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
648963|NCT02245360|P2|Participant Flow|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
648964|NCT02245360|P1|Participant Flow|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
648965|NCT02245360|O2|Outcome|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
648966|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
648967|NCT02245360|O2|Outcome|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
648968|NCT02245360|O1|Outcome|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
648969|NCT02245360|E2|Reported Event|Placebo|"Placebo~placebo: placebo tablet given once daily over 60 days"
648970|NCT02245360|E1|Reported Event|Grass Tablet 75,000 SQ-T|"Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)~Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days"
648971|NCT02244840|B1|Baseline|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
648972|NCT02244840|P1|Participant Flow|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
648973|NCT02244840|O1|Outcome|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
648974|NCT02244840|E1|Reported Event|Electronic Bidet and Sitz Bath|"Electronic bidet for 3 minutes and sitz bath for 3 minutes, at another day, for each subject~Electronic bidet: commercial electronic bidet~Sitz bath: Conventional sitz bath"
648975|NCT02244580|B1|Baseline|FinHer Patients|"Of all patients, FFPE tumour block was processed with the RNXtract RNA extraction kit (BioNTech Diagnostics GmbH, Mainz) using a magnetic particle-based assay (Supplemental file 1A).~RT-qPCR was done with the MammaTyper kit (BioNTech Diagnostics GmbH, Mainz) for ESR1, PGR, ERBB2 and MKI67."
648976|NCT02244580|P1|Participant Flow|MammaTyper™|"MammaTyper™ kit will be used to assess tumor material of patients enrolled into the FinHer trial.~MammaTyper™: MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67."
648977|NCT02244580|O2|Outcome|OS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of OS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
648978|NCT02244580|O1|Outcome|DDFS According to MKI67 mRNA and Ki-67 Protein (IHC) Levels|Determination of DDFS of patients according to MKI67 mRNA (RT-qPCR) and Ki-67 protein (IHC) levels
648982|NCT02244580|E1|Reported Event||Since only tumor material was used, adverse events were not documented within the MammaTyper Study
648983|NCT02243943|B3|Baseline|Total|Total of all reporting groups
648984|NCT02243943|B2|Baseline|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
648985|NCT02243943|B1|Baseline|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
648986|NCT02243943|P2|Participant Flow|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
648987|NCT02243943|P1|Participant Flow|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
648988|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
648989|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
648990|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
648991|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
648992|NCT02243943|O2|Outcome|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
648993|NCT02243943|O1|Outcome|Sugammadex|"Subjects in this arm will be reversed with sugammadex 2-4 mg/kg~Sugammadex"
648994|NCT02243943|E2|Reported Event|Neostigmine|"subjects in this arm will be reversed with neostigmine 1.0-2.5 mg and atropine 0.5-1.0mg~Neostigmine"
648999|NCT02243280|B9|Baseline|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
649000|NCT02243280|B8|Baseline|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649001|NCT02243280|B7|Baseline|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649002|NCT02243280|B6|Baseline|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
649003|NCT02243280|B5|Baseline|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649004|NCT02243280|B4|Baseline|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649005|NCT02243280|B3|Baseline|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649006|NCT02243280|B2|Baseline|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
649007|NCT02243280|B1|Baseline|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649008|NCT02243280|P11|Participant Flow|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
649009|NCT02243280|P10|Participant Flow|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
649010|NCT02243280|P9|Participant Flow|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
649011|NCT02243280|P8|Participant Flow|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649012|NCT02243280|P7|Participant Flow|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649013|NCT02243280|P6|Participant Flow|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
649014|NCT02243280|P5|Participant Flow|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649015|NCT02243280|P4|Participant Flow|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649016|NCT02243280|P3|Participant Flow|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649017|NCT02243280|P2|Participant Flow|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
649018|NCT02243280|P1|Participant Flow|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649019|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
649020|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
649021|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
649022|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649023|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649024|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
649025|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649026|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649027|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649028|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
649029|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649030|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
649031|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
649032|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
649033|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649034|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649035|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
649036|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649037|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649038|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649039|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
649040|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649041|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
649042|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
649043|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
649044|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649045|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649046|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
649047|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649048|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649049|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649050|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
649051|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649052|NCT02243280|O11|Outcome|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1- infected participants without cirrhosis
649053|NCT02243280|O10|Outcome|Arm J|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis (never opened – Sponsor decision)
649054|NCT02243280|O9|Outcome|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6-infected participants without cirrhosis
649055|NCT02243280|O8|Outcome|Arm H|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649056|NCT02243280|O7|Outcome|Arm G|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
649057|NCT02243280|O6|Outcome|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1- infected participants with compensated cirrhosis
649058|NCT02243280|O5|Outcome|Arm E|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD + ribavirin (RBV) 800 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis (never opened – Sponsor decision)
653889|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
649059|NCT02243280|O4|Outcome|Arm D|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649060|NCT02243280|O3|Outcome|Arm C|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis (never opened – Sponsor decision)
649061|NCT02243280|O2|Outcome|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1- infected participants without cirrhosis
649062|NCT02243280|O1|Outcome|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649063|NCT02243280|E5|Reported Event|Arm K|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 8 weeks in HCV genotype 1-infected participants without cirrhosis
649064|NCT02243280|E4|Reported Event|Arm I|ABT-493 300 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 4-, 5-, and 6- infected participants without cirrhosis
649065|NCT02243280|E3|Reported Event|Arm F|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants with compensated cirrhosis
649066|NCT02243280|E2|Reported Event|Arm B|ABT-493 200 mg once daily (QD) + ABT-530 40 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649067|NCT02243280|E1|Reported Event|Arm A|ABT-493 200 mg once daily (QD) + ABT-530 120 mg QD for 12 weeks in HCV genotype 1-infected participants without cirrhosis
649068|NCT02243202|B5|Baseline|Total|Total of all reporting groups
649069|NCT02243202|B4|Baseline|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649070|NCT02243202|B3|Baseline|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649071|NCT02243202|B2|Baseline|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649072|NCT02243202|B1|Baseline|Placebo|Participants received placebo tablets orally for 26 weeks.
649687|NCT02234011|O1|Outcome|Treatment|No participants enrolled in treatment portion of study.
649073|NCT02243202|P4|Participant Flow|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649074|NCT02243202|P3|Participant Flow|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649075|NCT02243202|P2|Participant Flow|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649076|NCT02243202|P1|Participant Flow|Placebo|Participants received placebo tablets orally for 26 weeks.
649077|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649078|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649079|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649080|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
649081|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649082|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649083|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649084|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
649085|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649086|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649087|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649088|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
649089|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649090|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649091|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649092|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
649093|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649094|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649095|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649096|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
649097|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649098|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649099|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649100|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
649101|NCT02243202|O4|Outcome|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649102|NCT02243202|O3|Outcome|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649103|NCT02243202|O2|Outcome|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649104|NCT02243202|O1|Outcome|Placebo|Participants received placebo tablets orally for 26 weeks.
649105|NCT02243202|E4|Reported Event|Canagliflozin 300 mg/Phentermine 15 mg|Participants received co-administration of canagliflozin 300 mg and phentermine 15 mg orally for 26 weeks.
649106|NCT02243202|E3|Reported Event|Canagliflozin 300 mg|Participants received canagliflozin 300 mg over-encapsulated tablets orally for 26 weeks.
649107|NCT02243202|E2|Reported Event|Phentermine 15 mg|Participants received phentermine 15 mg over-encapsulated tablets orally for 26 weeks.
649108|NCT02243202|E1|Reported Event|Placebo|Participants received placebo tablets orally for 26 weeks.
649109|NCT02243176|B3|Baseline|Total|Total of all reporting groups
649110|NCT02243176|B2|Baseline|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649111|NCT02243176|B1|Baseline|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649112|NCT02243176|P2|Participant Flow|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649113|NCT02243176|P1|Participant Flow|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649258|NCT02241889|P3|Participant Flow|APN, SAP and APX (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), open loop (Sensor Augmented Pump SAP), and closed loop with exercise announcement (APX). Each visit was 21 hours.
649114|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649115|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649116|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649117|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649118|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649119|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649120|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649121|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649122|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649123|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649124|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649125|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649126|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649248|NCT02242019|B1|Baseline|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
649127|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649128|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649129|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649130|NCT02243176|O2|Outcome|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649131|NCT02243176|O1|Outcome|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649366|NCT02239926|P1|Participant Flow|Ranolazine|tablet, 1000 mg twice daily for four weeks
649367|NCT02239926|O2|Outcome|Placebo|Placebo
649132|NCT02243176|E2|Reported Event|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocalted to this arm.
649133|NCT02243176|E1|Reported Event|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd. An estimated total of 480 patients (240 per treatment arm) will be randomized in a 1:1 ratio to the active treatment arm and the active comparator arm. So estimated 240 patients will be allocated to this arm.
649134|NCT02243046|B4|Baseline|Total|Total of all reporting groups
649135|NCT02243046|B3|Baseline|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649136|NCT02243046|B2|Baseline|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649137|NCT02243046|B1|Baseline|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649138|NCT02243046|P3|Participant Flow|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649139|NCT02243046|P2|Participant Flow|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649140|NCT02243046|P1|Participant Flow|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649141|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649142|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649143|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649144|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649145|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649146|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649249|NCT02242019|P1|Participant Flow|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
649147|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649148|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649149|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649150|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649151|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649152|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649153|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649154|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649155|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649156|NCT02243046|O3|Outcome|Active Comparator|"1450 ppm sodium fluoride/triclosan toothpaste~Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649157|NCT02243046|O2|Outcome|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649158|NCT02243046|O1|Outcome|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649159|NCT02243046|E3|Reported Event|Active Comparator|1450 ppm sodium fluoride/triclosan toothpaste Active Comparator: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
649160|NCT02243046|E2|Reported Event|Experimental Toothpaste|"1450 ppm sodium fluoride toothpaste with a zinc base~Experimental toothpaste: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649161|NCT02243046|E1|Reported Event|Control Toothpaste|"1450 ppm Fluoride toothpaste~Control toothpaste: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study."
649162|NCT02243007|B3|Baseline|Total|Total of all reporting groups
649163|NCT02243007|B2|Baseline|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649164|NCT02243007|B1|Baseline|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649202|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
653890|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
649165|NCT02243007|P2|Participant Flow|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649166|NCT02243007|P1|Participant Flow|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649207|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649167|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649168|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649169|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649170|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649171|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649172|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649173|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649174|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649203|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649250|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
649175|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649176|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
654471|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
649177|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649178|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649179|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649180|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649181|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649182|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649183|NCT02243007|O2|Outcome|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649184|NCT02243007|O1|Outcome|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649204|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649251|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
653891|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
649185|NCT02243007|E2|Reported Event|Gemcitabine/Nab-Paclitaxel- Arm B|"Treatment will be administered on an outpatient basis. Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel).~Intravenous administration of the Gemcitabine/Nab-paclitaxel regimen on predetermined days of each 28 day treatment cycle (unless a delay is mandated by toxicity criteria). A cycle of Gemcitabine/Nab-paclitaxel will constitute a 28 day treatment period.~After Gemcitabine/Nab-paclitaxel, all patients without progressive disease will proceed to radiation therapy with the standard dose of capecitabine~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~Gemcitabine/nab-Paclitaxel~Radiation therapy~Capecitabine"
649208|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649368|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
649186|NCT02243007|E1|Reported Event|Folfirinox-ARM A|"Upon registration patients will be randomized to Arm A (FOLFIRINOX) or Arm B (Gemcitabine/nab-Paclitaxel~Treatment will be administered on an outpatient basis and will include intravenous administration of the FOLFIRINOX regimen on predetermined days.~After completion of FOLFIRINOX all patients without progressive disease will proceed with radiation therapy with the standard dose of capecitabine.~Between 2 and 4 weeks after radiation is complete, patients will proceed for surgical resection of pancreatic cancer~FOLFIRINOX~Radiation therapy~Capecitabine"
649187|NCT02242994|B1|Baseline|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
649188|NCT02242994|P1|Participant Flow|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
649189|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
649190|NCT02242994|O1|Outcome|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
649191|NCT02242994|E1|Reported Event|Dynavox Maestro and Experimental App|"Receives both Experimental App and Dynavox Maestro to communicate. Each participant will receive both devices. Order of device received is randomly assigned.~Dynavox Maestro: Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.~Experimental App: Participant receives experimental app to test speed and error rate of communication."
649192|NCT02242643|B3|Baseline|Total|Total of all reporting groups
649193|NCT02242643|B2|Baseline|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649194|NCT02242643|B1|Baseline|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649195|NCT02242643|P2|Participant Flow|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649196|NCT02242643|P1|Participant Flow|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649197|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649198|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649199|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649200|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649201|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649205|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649206|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649209|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
649210|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
649211|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649212|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649213|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
649214|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
649215|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
649216|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine. The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age).
649217|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649218|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649219|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649220|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649221|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649222|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
653892|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
649223|NCT02242643|O2|Outcome|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649224|NCT02242643|O1|Outcome|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649225|NCT02242643|E2|Reported Event|Fluzone® Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluzone® Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649226|NCT02242643|E1|Reported Event|FluLaval™ Quadrivalent Group|"Subjects in this group received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of FluLaval™ Quadrivalent vaccine.~The vaccine was administered intramuscularly into the anterolateral region of the thigh (subjects below 12 months of age) or in the deltoid muscle of the non-dominant arm (subjects ≥12 months of age)."
649228|NCT02242630|B4|Baseline|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
649229|NCT02242630|B3|Baseline|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649230|NCT02242630|B2|Baseline|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649231|NCT02242630|B1|Baseline|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649232|NCT02242630|P4|Participant Flow|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
649233|NCT02242630|P3|Participant Flow|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649234|NCT02242630|P2|Participant Flow|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649235|NCT02242630|P1|Participant Flow|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649236|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
649237|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649238|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649239|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649240|NCT02242630|O4|Outcome|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
649241|NCT02242630|O3|Outcome|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649242|NCT02242630|O2|Outcome|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649243|NCT02242630|O1|Outcome|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649244|NCT02242630|E4|Reported Event|Triamcinolone, 40 mg|"Triamcinolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone"
649245|NCT02242630|E3|Reported Event|Triamcinolone, 20 mg|"Triamcinolone, 20 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649246|NCT02242630|E2|Reported Event|Methylprednisolone, 40 mg|"Methylprednisolone, 40 mg, will be injected~Methylprednisolone, 20 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649247|NCT02242630|E1|Reported Event|Methylprednisolone, 20 mg|"Methylprednisolone, 20 mg, will be injected~Methylprednisolone, 40 mg: Compared with intrabursal triamcinolone~Triamcinolone, 20 mg: Compared with methylprednisolone~Triamcinolone, 40 mg: Compared with methylprednisolone"
649252|NCT02242019|O1|Outcome|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
649253|NCT02242019|E1|Reported Event|Erchonia LUNULA|The Erchonia LUNULA emits both red light (635 nm) and blue light (405 nm) to the affected toenail for 12 minutes per treatment for 4 treatments, each treatment one week apart.
649254|NCT02241889|B1|Baseline|All Study Participants|All study participants underwent three 21 hour study visits using either standard of care insulin pump therapy, closed loop control, or closed loop control with adjustments to insulin and glucagon after exercise announcement. Treatment order was randomized.
649255|NCT02241889|P6|Participant Flow|APX, APN, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), closed loop (APN) and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
649256|NCT02241889|P5|Participant Flow|APX, SAP, APN (21 Hours)|The randomization order for subjects in this arm was closed loop with exercise announcement (APX), open loop (Sensor Augmented Pump SAP) and closed loop (APN). Each visit was 21 hours.
649257|NCT02241889|P4|Participant Flow|APN, APX, SAP (21 Hours)|The randomization order for subjects in this arm was closed loop (APN), closed loop with exercise announcement (APX), and open loop (Sensor Augmented Pump SAP). Each visit was 21 hours.
649369|NCT02239926|O2|Outcome|Placebo|Placebo
649370|NCT02239926|O1|Outcome|Ranolazine|tablet, 1000 mg twice daily for four weeks
649259|NCT02241889|P2|Participant Flow|SAP, APX, APN (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop with exercise announcement (APX), and closed loop (APN). Each visit was 21 hours.
649260|NCT02241889|P1|Participant Flow|SAP, APN, APX (21 Hours)|The randomization order for subjects in this arm was open loop (Sensor Augmented Pump SAP), closed loop (APN) and closed loop with exercise announcement (APX). Each visit was 21 hours.
649261|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649262|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649263|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649264|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649265|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649266|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649267|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649268|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649269|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649270|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
653893|NCT02196077|O4|Outcome|BD MDI 320 ug|BD MDI 320 ug
649271|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649272|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649273|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649371|NCT02239926|E2|Reported Event|Placebo|Placebo
649372|NCT02239926|E1|Reported Event|Ranolazine|tablet, 1000 mg twice daily for four weeks
649373|NCT02239744|B3|Baseline|Total|Total of all reporting groups
650491|NCT02226198|O3|Outcome|Maintenance|Maintenance Phase, Safety analysis set
649274|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649275|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649276|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649277|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649278|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649279|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649280|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649281|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649282|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649283|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649284|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649285|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
653894|NCT02196077|O3|Outcome|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
649286|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649287|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649288|NCT02241889|O3|Outcome|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649289|NCT02241889|O2|Outcome|Closed-loop Without Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649290|NCT02241889|O1|Outcome|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649291|NCT02241889|E3|Reported Event|Closed-loop With Adjustment|"Subjects will undergo 21 hour study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will be annouced to the controller and adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649292|NCT02241889|E2|Reported Event|Closed-loop Without Adjustment|"Subjects will undergo 21 study using the Closed-loop Artificial Pancreas Controller to manage blood sugar. Exercise will not be annouced to the controller and no adjustments to insulin and glucagon delivery will be made.~Closed-loop Artificial Pancreas Controller: Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon."
649293|NCT02241889|E1|Reported Event|Standard Insulin Pump Therapy|"Subjects will undergo 21 hour study with exercise using Insulin pump therapy and managing their blood glucose as they normally would.~Insulin pump therapy: Subject's own insulin pump will be used to manage blood glucose."
649294|NCT02241785|B1|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks
649295|NCT02241785|P1|Participant Flow|Natalizumab|natalizumab 300 mg intravenously (IV) every 4 weeks
649296|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
649297|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
649298|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
649299|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
649300|NCT02241785|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks
649301|NCT02241785|E1|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks
649302|NCT02241486|B1|Baseline|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
649303|NCT02241486|P1|Participant Flow|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
649304|NCT02241486|O1|Outcome|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
649305|NCT02241486|E1|Reported Event|Sublingual Fentanyl Spray|"Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.~Sublingual Fentanyl Spray: Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement)."
649306|NCT02240628|B3|Baseline|Total|Total of all reporting groups
649307|NCT02240628|B2|Baseline|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
649308|NCT02240628|B1|Baseline|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
649400|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649309|NCT02240628|P2|Participant Flow|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
649310|NCT02240628|P1|Participant Flow|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
649311|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
650492|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
649312|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
649313|NCT02240628|O2|Outcome|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
649314|NCT02240628|O1|Outcome|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
649315|NCT02240628|E2|Reported Event|Propofol -Saline Mixture|"All patients from both groups will receive a Synera Patch. Patienst in this group will receive Propofol mixed with Saline. Pain will be evaluated on Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Saline: Patients in arm 2 will receive Saline with the Propofol."
649316|NCT02240628|E1|Reported Event|Propofol-Lidocaine Mixture|"All patients from both groups will receive a Synera Patch. Patients in this group will receive Propofol mixed with Lidocaine. Pain will be evaluated during the Propofol injection by both a blinded observer and a blinded anesthesia member.~Lidocaine/tetracaine transdermal patch: All patients in arm 1 and arm 2 will receive the Synera Patch.~Lidocaine: Patients in arm 1 will receive Lidocaine with the Propofol."
649317|NCT02240368|B4|Baseline|Total|Total of all reporting groups
649318|NCT02240368|B3|Baseline|Group 3|Children age between 37 months to 144 months
649319|NCT02240368|B2|Baseline|Group 2|Children age between 13 months and 36 months
649320|NCT02240368|B1|Baseline|Group 1|Children age between 1 month to 12 months
649321|NCT02240368|P3|Participant Flow|Group 3|Children age between 37 months to 144 months
649322|NCT02240368|P2|Participant Flow|Group 2|Children age between 13 months and 36 months
649323|NCT02240368|P1|Participant Flow|Group 1|Children age between 1 month to 12 months
649324|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
649325|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
649326|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
649327|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
649328|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
649329|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
649330|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
649331|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
649332|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
649333|NCT02240368|O3|Outcome|Group 3|Children age between 37 months to 144 months
649334|NCT02240368|O2|Outcome|Group 2|Children age between 13 months and 36 months
649335|NCT02240368|O1|Outcome|Group 1|Children age between 1 month to 12 months
649336|NCT02240368|E3|Reported Event|Group 3|Children age between 37 months to 144 months
649337|NCT02240368|E2|Reported Event|Group 2|Children age between 13 months and 36 months
649338|NCT02240368|E1|Reported Event|Group 1|Children age between 1 month to 12 months
649339|NCT02240329|B1|Baseline|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
649340|NCT02240329|P1|Participant Flow|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
649341|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
649374|NCT02239744|B2|Baseline|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
649375|NCT02239744|B1|Baseline|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
649376|NCT02239744|P2|Participant Flow|True Purifiers First, Then Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used true air purifiers.In the second period, this group used sham air purifiers.
649342|NCT02240329|O1|Outcome|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
649343|NCT02240329|E1|Reported Event|Individuals With TBI|"Individuals who have sustained a traumatic brain injury during the previous five years. Will have the following tests performed: Neuropsychological Testing and Measures of TBI severity; Cough and respiratory measures (including Maximum Respiratory Pressures); and Capsaicin cough sensitivity testing.~Neuropsychological Testing and Measures of TBI severity: A brief cognitive assessment will be given to each participant when he or she presents for this project.~Respiratory measures: We will collect measures of cough airflow and breathing strength.~Capsaicin cough sensitivity testing: Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is."
649344|NCT02239978|B3|Baseline|Total|Total of all reporting groups
649345|NCT02239978|B2|Baseline|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649346|NCT02239978|B1|Baseline|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649347|NCT02239978|P2|Participant Flow|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649348|NCT02239978|P1|Participant Flow|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649349|NCT02239978|O2|Outcome|Parkinson's Disease Off Medication|"These are the same participants as in the Parkinson's disease group, assessed Off their levodopa medication"
649350|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649351|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
649352|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649353|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649354|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
649355|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649356|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649357|NCT02239978|O3|Outcome|Parkinson's Disease Off Medication|"These are the same individuals in the Parkinson's disease group, but Off their levodopa"
649358|NCT02239978|O2|Outcome|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649359|NCT02239978|O1|Outcome|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649360|NCT02239978|E2|Reported Event|Control|"Age-matched healthy adults~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649548|NCT02237092|E2|Reported Event|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
649361|NCT02239978|E1|Reported Event|Parkinsons Disease|"Individuals with Parkinsons disease~Postural perturbation: Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance."
649362|NCT02239926|B3|Baseline|Total|Total of all reporting groups
649363|NCT02239926|B2|Baseline|Placebo|Placebo
649364|NCT02239926|B1|Baseline|Ranolazine|tablet, 1000 mg twice daily for four weeks
649365|NCT02239926|P2|Participant Flow|Placebo|Placebo
654472|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
649377|NCT02239744|P1|Participant Flow|Sham Purifiers First, Then True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. In the first period, this group used sham air purifiers with the only difference being removal of the filter gauze. In the second period, this group used true air purifiers.
649378|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
649379|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
649380|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
649381|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
649382|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
649383|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
649384|NCT02239744|O2|Outcome|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
649385|NCT02239744|O1|Outcome|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze
649386|NCT02239744|E2|Reported Event|True Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used true air purifiers.
649387|NCT02239744|E1|Reported Event|Sham Purifiers|The 10 rooms were randomized into two groups of 5 rooms each. This group used sham air purifiers with the only difference being removal of the filter gauze.
649388|NCT02239692|B3|Baseline|Total|Total of all reporting groups
649389|NCT02239692|B2|Baseline|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649390|NCT02239692|B1|Baseline|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649391|NCT02239692|P2|Participant Flow|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649392|NCT02239692|P1|Participant Flow|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649393|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649394|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649395|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649396|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649397|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649398|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649399|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649401|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649402|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649403|NCT02239692|O2|Outcome|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649404|NCT02239692|O1|Outcome|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649405|NCT02239692|E2|Reported Event|PICOPREP Tailored Dosing Schedule|"Dose 1 was given 10-18 hours before colonoscopy and Dose 2 was given 4-6 hours before colonoscopy.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649406|NCT02239692|E1|Reported Event|PICOPREP Day-before Dosing Schedule|"Dose 1 was given before 8:00 AM on day before colonoscopy and Dose 2 was given 6-8 hours after Dose 1.~PICOPREP: Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution"
649407|NCT02239289|B1|Baseline|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649408|NCT02239289|P1|Participant Flow|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
654473|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
649409|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649410|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649411|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649412|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649413|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649414|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649415|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649416|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649417|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649418|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649419|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649420|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649421|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649422|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649423|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649424|NCT02239289|O1|Outcome|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649425|NCT02239289|E1|Reported Event|Biofeedback|"Subjects will be provided with four sessions of supervised biofeedback training~Biofeedback: Idem as described in the arm section (above)"
649426|NCT02238782|B1|Baseline|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
649427|NCT02238782|P1|Participant Flow|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
649428|NCT02238782|O1|Outcome|Selumetinib|Selumetinib 75 mg oral followed by IV carbon 14 selumetinib (80 micrograms) administered 1 hour 15 minutes after the oral dose.
649429|NCT02238782|E1|Reported Event|Selumetinib|Patients received a single oral dose of selumetinib 75mg followed by IV carbon 14 selumetinib (80 micrograms) 1 hour 15 minutes after receiving the oral dose.
649430|NCT02238379|B3|Baseline|Total|Total of all reporting groups
649431|NCT02238379|B2|Baseline|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649432|NCT02238379|B1|Baseline|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649433|NCT02238379|P2|Participant Flow|Placebo First, Then Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649434|NCT02238379|P1|Participant Flow|Oxytocin First, Then Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649435|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649436|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649437|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649438|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649439|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649440|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649441|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649723|NCT02233998|E3|Reported Event|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649442|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649443|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649444|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649445|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649446|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649447|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649448|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649449|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649450|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649451|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649452|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649453|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649454|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649455|NCT02238379|O2|Outcome|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649456|NCT02238379|O1|Outcome|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649457|NCT02238379|E2|Reported Event|Placebo|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Placebo: Placebo will contain all ingredients except the active oxytocin in the Nasal Spray."
649458|NCT02238379|E1|Reported Event|Oxytocin|"Each participant will receive both the oxytocin nasal spray in one visit AND the placebo nasal spray in another visit (randomized) in this design.~Oxytocin: 24 International Units of Oxytocin in a Nasal Spray"
649459|NCT02238080|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649460|NCT02238080|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and chronic kidney disease (CKD) who were on dialysis therapy, and who initiated erythropoiesis-stimulating agent (ESA) treatment with methoxy polyethylene glycol-epoetin beta (Mircera) or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649613|NCT02235285|B1|Baseline|All Study Participants|Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.
649461|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649462|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649463|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649464|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649465|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649466|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649467|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649468|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649469|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649470|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649471|NCT02238080|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649472|NCT02238080|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants with anemia and CKD who were on dialysis therapy, and who initiated ESA treatment with methoxy polyethylene glycol-epoetin beta or who were on stable methoxy polyethylene glycol-epoetin beta maintenance therapy, were treated according to the usual standard of care and current best practice guidelines.
649473|NCT02238067|B1|Baseline|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649474|NCT02238067|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with Chronic Kidney Disease (CKD) who were not on dialysis and treated with Erythropoiesis-Stimulating Agents (ESA) according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649475|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649476|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649477|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649478|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649479|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649480|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649481|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649482|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649483|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649484|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649485|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649685|NCT02234011|B1|Baseline|Treatment|No participants enrolled in treatment portion of study, and therefore never completed a baseline visit. One subject completed a screening visit and then withdrew from study due to time commitments.
649486|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649487|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649488|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649489|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649490|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649491|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649492|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649493|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649494|NCT02238067|O1|Outcome|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649495|NCT02238067|E1|Reported Event|Chronic Renal Anemia Participants|Participants with CKD who were not on dialysis and treated with ESA according to the usual standard of care and best practice guidelines, were interviewed by physician who completed the satisfaction surveys on anemia treatment at baseline and at 6 months follow-up visit.
649496|NCT02238028|B1|Baseline|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days including a 2-hour walking along the streets on the 2nd day along a fixed route. After a 2-week rest period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days including the 2-hour walking along the streets on the 2nd day along the same fixed route. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649497|NCT02238028|P2|Participant Flow|Not Wearing Respirator First,Then Wearing Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649498|NCT02238028|P1|Participant Flow|Wearing Respirator First,Then Not Wearing Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649724|NCT02233998|E2|Reported Event|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649499|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649500|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649552|NCT02236767|O1|Outcome|rTMS Treatment|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
654474|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
649501|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649502|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649503|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649504|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649505|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649506|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649507|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group did not wear respirator but participated all the measurements on health indicator and ambient air pollution for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to wear the respirator for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649508|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649509|NCT02238028|O1|Outcome|All Study Participants|"The recruited healthy subjects were randomly allocated into two groups. In the first intervention period, this group wore respirator for 2 continuous days. After a 3-week washout period, the 2nd intervention period started and they changed to not wearing the respirator but participated all the measurements of health indicators and ambient air pollution for 2 continuous days. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649510|NCT02238028|O2|Outcome|Not Wear Respirator|The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649511|NCT02238028|O1|Outcome|Wear Respirator|"The recruited healthy subjects were randomly allocated into two groups.In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649512|NCT02238028|O2|Outcome|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649665|NCT02234427|P1|Participant Flow|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
649513|NCT02238028|O1|Outcome|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649514|NCT02238028|E2|Reported Event|Not Wear Respirator|The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.
649515|NCT02238028|E1|Reported Event|Wear Respirator|"The subjects were randomized into 2 groups. In each intervention, one group wore the high-efficiency respirator as much as possible for continuous 48hr and the other group behaved as usual. After a three-week interval, the two groups exchanged their roles in wearing the respirator or not. The same protocol on the measurements of health indicators and ambient air pollution was applied in the 1st intervention and 2nd intervention period.~Wear respirator: Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor."
649516|NCT02237118|B3|Baseline|Total|Total of all reporting groups
649517|NCT02237118|B2|Baseline|UrgoTul|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
649518|NCT02237118|B1|Baseline|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
649519|NCT02237118|P2|Participant Flow|UrgoTul|"Pain on removal by VAS~UrgoTul"
649520|NCT02237118|P1|Participant Flow|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One"
649521|NCT02237118|O2|Outcome|UrgoTul|Condition of the surrounding skin
649522|NCT02237118|O1|Outcome|Mepitel One|Condition of the surrounding skin
649523|NCT02237118|O2|Outcome|Safety UrgoTul|Adverse Event and Adverse Device Effect
649524|NCT02237118|O1|Outcome|Safety Mepitel One|Adverse Event and Adverse Device Effect
649525|NCT02237118|O2|Outcome|Condition of the Wound, UrgoTul|Condition of the wound, UrgoTul, assessed by the investigator
649526|NCT02237118|O1|Outcome|Condition of the Wound Mepitel One|Condition of the wound assesed by the investigator
649527|NCT02237118|O2|Outcome|UrgoTul|Complete healing was reported for 27 subjects ( 49,1%) in theUrgoTul group.
649528|NCT02237118|O1|Outcome|Mepitel One|Complete healing was reported for 39 subjects ( 68,4%) in the Mepitel One group.
649529|NCT02237118|O2|Outcome|UrgoTul|"Non-Painful dressing removal, measured by VAS~Mepitel One~UrgoTul"
649530|NCT02237118|O1|Outcome|Mepitel One|"Non-Painful dressing removal, measured by VAS~Mepitel One~UrgoTul"
649531|NCT02237118|E2|Reported Event|UrgoTul|"Pain on removal by VAS~Mepitel One~UrgoTul"
649532|NCT02237118|E1|Reported Event|Mepitel One|"Pain on dressing removal, by VAS~Mepitel One~UrgoTul"
649533|NCT02237092|B1|Baseline|Measurement of IAP|Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.The data obtained are in inches of water column were translated in millimeters of mercury.
649534|NCT02237092|P1|Participant Flow|Measurement of IAP|"The data obtained are in inches of water column were translated in millimeters of mercury.~Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration."
649535|NCT02237092|O2|Outcome|Level of IAP = > 16 mm Hg|number of pregnant women with Level of IAP = > 16 mm Hg
649536|NCT02237092|O1|Outcome|Level of IAP < 16 mm Hg|number of pregnant women with Level of IAP < 16 mm Hg
649537|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
649538|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
649539|NCT02237092|O2|Outcome|Obesity|BMI = > 30.00
649540|NCT02237092|O1|Outcome|No Obesity|BMI < = 29.99
649541|NCT02237092|O2|Outcome|Level of Sensory Block < = Th5 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
649542|NCT02237092|O1|Outcome|Level of Sensory Block => Th4 (Spinal Anesthesia)|Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
649543|NCT02237092|O4|Outcome|Grade III|(21 - 25.99 mm Hg)
649544|NCT02237092|O3|Outcome|Grade II|(16 - 20.99 mm Hg)
649545|NCT02237092|O2|Outcome|Grade I|(12 - 15.99 mm Hg)
649546|NCT02237092|O1|Outcome|Physiological Norm|(≤11,99 mm Hg)
649547|NCT02237092|O1|Outcome|Intra-abdominal Pressure (IAP) in Pregnant Women|Average IAP in pregnant women
650472|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
649549|NCT02237092|E1|Reported Event|Level of Sensory Block => Th4 (Spinal Anesthesia)|Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
649550|NCT02236767|B1|Baseline|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
649551|NCT02236767|P1|Participant Flow|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
649666|NCT02234427|O1|Outcome|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
649553|NCT02236767|E1|Reported Event|TMS Therapy|"NeuroStar TMS Therapy System~Neurostar TMS Therapy System: Treatment will entail daily (5 days/week) sessions of rTMS for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC)."
649554|NCT02236611|B3|Baseline|Total|Total of all reporting groups
649555|NCT02236611|B2|Baseline|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
649556|NCT02236611|B1|Baseline|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
649557|NCT02236611|P2|Participant Flow|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
649558|NCT02236611|P1|Participant Flow|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
649559|NCT02236611|O2|Outcome|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
649560|NCT02236611|O1|Outcome|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
649561|NCT02236611|E2|Reported Event|GLYCO 44 mcg QD|Participants received glycopyrronium bromide (GLYCO) inhalation capsules 44 mcg QD in morning via an alternative dry powder inhaler (DPI) for 12 weeks. Participants also received albuterol/salbutamol via MDI or nebules as needed throughout the study.
649562|NCT02236611|E1|Reported Event|UMEC 62.5 mcg QD|Participants received Umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) for 12 weeks. Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as needed throughout the study.
649563|NCT02236598|B3|Baseline|Total|Total of all reporting groups
649564|NCT02236598|B2|Baseline|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
649565|NCT02236598|B1|Baseline|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
649566|NCT02236598|P2|Participant Flow|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
649567|NCT02236598|P1|Participant Flow|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
649568|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
649569|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
649570|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
649571|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
649572|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
649573|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
649574|NCT02236598|O2|Outcome|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
649667|NCT02234427|E1|Reported Event|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
649722|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649575|NCT02236598|O1|Outcome|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
649576|NCT02236598|E2|Reported Event|Placebo|"Placebo - An inert powdered placebo will be identically encapsulated as the Klor-Con intervention tablets to maintain blinding. Participants will be instructed to take two tablets twice daily in a blinded encapsulated form, for 3 months~Subjects will be instructed to take the pills~Placebo"
649577|NCT02236598|E1|Reported Event|K+ Supplementation|"K-supplement- Klor-Con® M10 is an immediately dispersing extended-release oral dosage form of potassium chloride containing 750 mg of microencapsulated potassium chloride, USP equivalent to 10 mEq of potassium in a tablet. Participants will be instructed to take two 10 mEq tablets twice daily in a blinded encapsulated form, for 3 months~K+ supplement"
649578|NCT02236546|B1|Baseline|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
649579|NCT02236546|P1|Participant Flow|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
649580|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
649581|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
649582|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
649583|NCT02236546|O1|Outcome|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
649725|NCT02233998|E1|Reported Event|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649584|NCT02236546|E1|Reported Event|FDG-PET/CT|"Patients undergo [18F]fluorodeoxyglucose (FDG) positron emission tomography (PET)/computed tomography (CT) up to 2 weeks prior to first dose of therapy, after completion of the first treatment course (day 21), and after completion of the fourth treatment course (day 84). Molecular assays on biopsied tissue obtained from a subset of patients will also undergo molecular assays, the results from which will be correlated with FDG-PET/CT data.~[18F]fluorodeoxyglucose: FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.~Molecular assays on biopsied tissue: Correlative studies~positron emission tomography: Undergo FDG-PET/CT~computed tomography: CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images."
649585|NCT02236130|B3|Baseline|Total|Total of all reporting groups
649686|NCT02234011|P1|Participant Flow|Treatment|No participants enrolled in treatment portion of study.
649586|NCT02236130|B2|Baseline|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649587|NCT02236130|B1|Baseline|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649588|NCT02236130|P2|Participant Flow|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649589|NCT02236130|P1|Participant Flow|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649590|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649591|NCT02236130|O1|Outcome|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649592|NCT02236130|O2|Outcome|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649593|NCT02236130|O1|Outcome|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649594|NCT02236130|E2|Reported Event|Regional|"General Anesthesia combined with regional block~Regional block: Single shot peripheral nerve block~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Local Anesthetic Ropivacaine: 0.5% Ropivacaine~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649595|NCT02236130|E1|Reported Event|General|"General Anesthesia only~General Anesthesia: General Anesthesia with O2/N2O/Sevoflurane~Opioids Morphine: Morphine~Oral pain medication Acetaminophen with Hydrocodone: Acetaminophen with Hydrocodone"
649596|NCT02235831|B1|Baseline|Overall|DACP MF, DACP MF (Low Add), and DACP (monovision) lenses worn in 6 different sequences as randomized in a crossover assignment.
649597|NCT02235831|P6|Participant Flow|Seq 6|DACP (monovision) lenses first, followed by DACP MF (Low Add) lenses next, and DACP MF lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
649598|NCT02235831|P5|Participant Flow|Seq 5|DACP (monovision) lenses first, followed by DACP MF lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
649599|NCT02235831|P4|Participant Flow|Seq 4|DACP MF (Low Add) lenses worn first, followed by DACP (monovision) lenses next, and DACP MF last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
649600|NCT02235831|P3|Participant Flow|Seq 3|DACP MF (Low Add) lenses worn first, followed by DACP MF lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
649601|NCT02235831|P2|Participant Flow|Seq 2|DACP MF lenses worn first, followed by DACP (monovision) lenses next, and DACP MF (Low Add) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
649602|NCT02235831|P1|Participant Flow|Seq I|DACP MF lenses worn first, followed by DACP MF (Low Add) lenses next, and DACP (monovision) lenses last. All lenses worn for 5±1 days in a daily wear daily disposable modality.
649603|NCT02235831|O2|Outcome|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
649604|NCT02235831|O1|Outcome|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
649605|NCT02235831|E3|Reported Event|DACP MF (Low Add)|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
649606|NCT02235831|E2|Reported Event|DACP MF|Nelfilcon A multifocal contact lenses worn during Period 1, 2, or 3 for 5±1 days.
649607|NCT02235831|E1|Reported Event|Monovision|Nelfilcon A contact lenses worn as monovision during Period 1, 2, or 3 for 5±1 days.
649608|NCT02235493|B1|Baseline|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
649609|NCT02235493|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
649610|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
649611|NCT02235493|O1|Outcome|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
649612|NCT02235493|E1|Reported Event|Retrospective Observational|Patients diagnosed with juvenile-onset hypophosphatasia (HPP) [ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age].
649614|NCT02235285|P1|Participant Flow|Breast Augmentation,Reoperation|The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.
649615|NCT02235285|O1|Outcome|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
649616|NCT02235285|E1|Reported Event|Breast Augmentation, Reoperation|The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
649617|NCT02235077|B3|Baseline|Total|Total of all reporting groups
654475|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
649618|NCT02235077|B2|Baseline|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649619|NCT02235077|B1|Baseline|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649620|NCT02235077|P2|Participant Flow|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649621|NCT02235077|P1|Participant Flow|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649622|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649623|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649624|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649625|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649626|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649627|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649628|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649629|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649630|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649631|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649651|NCT02235064|O2|Outcome|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
649726|NCT02233985|B3|Baseline|Total|Total of all reporting groups
649632|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649633|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649634|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649635|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649636|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649637|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649638|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649639|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649640|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649641|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649642|NCT02235077|O2|Outcome|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649643|NCT02235077|O1|Outcome|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649644|NCT02235077|E2|Reported Event|Placebo|"Placebo 25mg or 100mg orally, once daily while in the hospital for 96 hours~Placebo: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649645|NCT02235077|E1|Reported Event|Spironolactone|"Spironolactone 25mg or 100 mg orally, once daily while in the hospital for 96 hours~Spironolactone: Patients receiving no MRA at home will receive either spironolactone 100 mg or matching placebo (4x25 mg study capsules) once daily for 96 hours.~Patients already receiving low-dose MRA at home will receive spironolactone 100 mg vs. 25 mg (1x25 mg spironolactone and 3 placebo study capsules) in hospital for 96 hours."
649646|NCT02235064|B3|Baseline|Total|Total of all reporting groups
649647|NCT02235064|B2|Baseline|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
649648|NCT02235064|B1|Baseline|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
649649|NCT02235064|P2|Participant Flow|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
649650|NCT02235064|P1|Participant Flow|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
649652|NCT02235064|O1|Outcome|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
649653|NCT02235064|E2|Reported Event|Placebo|"Identical appearing capsule daily containing color-matched cellulose only~Placebo: Capsule containing cellulose powder of same color as experimental arm"
649654|NCT02235064|E1|Reported Event|Sertraline|"Capsules containing crushed sertraline 50 mg combined with identically colored cellulose, daily for 12 weeks, followed by 4 day 25 mg taper~Sertraline: Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper"
649655|NCT02234479|B3|Baseline|Total|Total of all reporting groups
649656|NCT02234479|B2|Baseline|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
649657|NCT02234479|B1|Baseline|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
649658|NCT02234479|P2|Participant Flow|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
649659|NCT02234479|P1|Participant Flow|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
649660|NCT02234479|O2|Outcome|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
649661|NCT02234479|O1|Outcome|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
649662|NCT02234479|E2|Reported Event|MediHoney (Group B)|"Group B (study target): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Medihoney daily, starting at the onset of RT and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Medihoney application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Medihoney within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~MediHoney (Group B): It helps the body’s natural healing processes in three key ways which have been shown to have healing benefits:~Maintain a balanced environment for healing.~Aids in reducing dermatitis.~Reduce affected area pH.2-3"
649663|NCT02234479|E1|Reported Event|Hydrophor (Group A)|"Group A (current standard of care): Patients will be instructed (by nurses and with printed study materials) to apply a thin layer of the Hydrophor daily, starting at the onset of radiation therapy (RT) and continuing until 2 weeks after the final RT session or until the RT site is healed (whichever is first). Hydrophor application should include the entire treatment area, including the axillae and shoulder/back area in patients treated with modified radical mastectomy. To avoid possible build-up effects, patients should not apply the Hydrophor within 4 hours of receiving RT. Patients should wash the application area daily with perfume-free soap and tap water. Patients will be asked to refrain from using other topical agents in the irradiated area.~Hydrophor (Group A): •Rehydrates dry, chapped or chafed skin~•May be used alone as a skin lubricant or protectant"
649664|NCT02234427|B1|Baseline|Aspirin|Aspirin: 2-week aspirin therapy (81mg/day)
649688|NCT02234011|E1|Reported Event|Treatment|"No participants enrolled in treatment portion of study. One subject had a screening visit, but since she never entered the treatment portion of the study and never received the study medication. Because she never had any exposure to the study medication and had no visits other than the initial screening visit, she was never at risk for any adverse events related to study medication.~No adverse events related to study medication were collected since no subjects ever entered the treatment phase of this study."
649689|NCT02233998|B4|Baseline|Total|Total of all reporting groups
649690|NCT02233998|B3|Baseline|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649691|NCT02233998|B2|Baseline|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649692|NCT02233998|B1|Baseline|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649693|NCT02233998|P3|Participant Flow|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649694|NCT02233998|P2|Participant Flow|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649695|NCT02233998|P1|Participant Flow|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649696|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649697|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649698|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649699|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649700|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649701|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649702|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649703|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649704|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649705|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649706|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649707|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649708|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649709|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649710|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649711|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649712|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649713|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649714|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649715|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649716|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649717|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649718|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
649719|NCT02233998|O1|Outcome|Negative Control (W002194-221P)|Negative Control - 5% Hydroalcohol Mouth Rinse (20 mL) twice daily after brushing
649720|NCT02233998|O3|Outcome|11965-059|Listerine® Zero™ Mouth Rinse (20 mL) twice daily after brushing
649721|NCT02233998|O2|Outcome|19292-116A|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL) twice daily after brushing
653895|NCT02196077|O2|Outcome|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
649727|NCT02233985|B2|Baseline|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
649728|NCT02233985|B1|Baseline|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
649729|NCT02233985|P2|Participant Flow|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
649730|NCT02233985|P1|Participant Flow|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
649731|NCT02233985|O2|Outcome|Saline Solution 0.9% (SS 0.9%) Group|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
649862|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649732|NCT02233985|O1|Outcome|Hypertonic Saline Solution 3% (SHS 3%)|We counted the hours from admission of the patient to the pediatric emergency department until hospital discharge. Staying hospitalized until they had mild respiratory stage scale scores for at least 2 hrs.
649733|NCT02233985|O2|Outcome|Saline Solution 0.9% (SS 0.9%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
649734|NCT02233985|O1|Outcome|Hypertonic Saline Solution 3% (HSS 3%) Group|Patients with moderate stages (6 to 10 points) and severe (11 to 16 points) were selected, performing subsequent measurements always 30 minutes after nebulization corresponding.
649735|NCT02233985|E2|Reported Event|Nebulized 3% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~3% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
649736|NCT02233985|E1|Reported Event|Nebulized 0.9% Sodium Chloride|"Salbutamol 100 micrograms / kg / dose administered 0.9 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.~0.9% Sodium Chloride: Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay."
649737|NCT02233842|B1|Baseline|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products"
649738|NCT02233842|P1|Participant Flow|Tobacco Use in Cancer Patients and Survivors|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
649739|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
649740|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
649741|NCT02233842|O1|Outcome|All Participants|"Cognitive testing (e.g. participant interview) of tobacco use in patients who have cancer and who have survived cancer.~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.~Three iterative rounds of testing of 10 patients each were planned in the protocol for revision and retesting."
649742|NCT02233842|O1|Outcome|All Participants|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
649743|NCT02233842|E1|Reported Event|Tobacco Use in Cancer Patients and Survivors|"People who have cancer and who have survived cancer~Participant interview: People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products."
649744|NCT02233647|B1|Baseline|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649789|NCT02233296|O1|Outcome|Fed Condition|Data presented is all subjects in the fed condition not by sequence of assigned cross-over (fed/fasted or fasted/fed).
649790|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
653896|NCT02196077|O1|Outcome|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
649745|NCT02233647|P1|Participant Flow|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
649746|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649747|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
650004|NCT02230956|B3|Baseline|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
649748|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649749|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649750|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649751|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649752|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649753|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649754|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649755|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649756|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649757|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649758|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649759|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649760|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649761|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649762|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649763|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649764|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649765|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649766|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649767|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649768|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649769|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649770|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649771|NCT02233647|O1|Outcome|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Cocaine was administered acutely after at least seven days of maintenance on each condition.~Placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo cocaine were determined during maintenance on placebo and phendimetrazine."
649772|NCT02233647|E1|Reported Event|Phendimetrazine Dose Escalation|"Subjects were maintained on oral placebo, 70 mg phendimetrazine/day, 140 mg phendimetrazine/day and 210 mg phendimetrazine/day in ascending order.~Intranasal cocaine (10, 20, 40 and 80 mg) was administered acutely after at least seven days of maintenance on each condition.~Intransasal placebo cocaine was administered acutely after at least seven days of maintenance on each condition.~Cocaine: The pharmacodynamic effects of cocaine were determined during maintenance on placebo and phendimetrazine.~Placebo: The pharmacodynamic effects of placebo were determined during maintenance on placebo and phendimetrazine."
649773|NCT02233309|B1|Baseline|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
649774|NCT02233309|P1|Participant Flow|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
649775|NCT02233309|O1|Outcome|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
649776|NCT02233309|E1|Reported Event|Monitoring of Pressures During Caudal Anesthesia|"Patients receiving caudal anesthesia as standard of care for a surgical procedure.~Our study adds a monitoring line to the needle for the caudal. The caudal itself is not part of the study.~Monitoring of pressures during caudal anesthesia: The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol."
649777|NCT02233296|B3|Baseline|Total|Total of all reporting groups
649778|NCT02233296|B2|Baseline|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
649779|NCT02233296|B1|Baseline|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
649780|NCT02233296|P2|Participant Flow|Group B|"Dosing Sequence: Administration of lasmiditan 200 mg in fasted state in Dosing Period 1 followed by administration in lasmiditan 200 mg fed state in Dosing Period 2.~Lasmiditan: 2 discrete doses separated by 6 days."
649781|NCT02233296|P1|Participant Flow|Group A|"Dosing Sequence: Administration of lasmiditan 200 mg in fed state in Dosing Period 1 followed by administration of lasmiditan 200 mg in fasted state in Dosing Period 2~Lasmiditan: 2 discrete doses separated by 6 days."
649782|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
649783|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
649784|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
649785|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
649786|NCT02233296|O2|Outcome|Fasted Condition (n=30)|Data presented is all subjects in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
649787|NCT02233296|O1|Outcome|Fed Condition (n=30)|Data presented is all subjects in the fed condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
649788|NCT02233296|O2|Outcome|Fasted Condition|Data presented is all subjects in the fasted condition, not by sequence of assigned cross-over (fed/fasted or fasted/fed).
649791|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
649792|NCT02233296|O2|Outcome|Fasted Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
649793|NCT02233296|O1|Outcome|Fed Condition|Subjects were randomized to dosing sequence of fed/fasted or fasted/fed. Data from specific condition (fed or fasted) were pooled for PK analysis.
649794|NCT02233296|E2|Reported Event|Fasted Condition (n=30)|Subjects were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while subject was in fasted condition are considered equally.
649795|NCT02233296|E1|Reported Event|Fed Condition (n=30)|Subjects were randomized to fed/fasted or fasted/fed. Conditions were pooled for analysis so regardless of sequence all AEs reported while subject was in fed condition are considered equally.
649796|NCT02233101|B3|Baseline|Total|Total of all reporting groups
649797|NCT02233101|B2|Baseline|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
649798|NCT02233101|B1|Baseline|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
654476|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
649799|NCT02233101|P2|Participant Flow|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
649800|NCT02233101|P1|Participant Flow|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
649801|NCT02233101|O2|Outcome|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
649802|NCT02233101|O1|Outcome|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
649803|NCT02233101|O2|Outcome|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
649804|NCT02233101|O1|Outcome|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
649805|NCT02233101|E2|Reported Event|Intravenous Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Intravenous Tranexamic Acid: Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative"
649806|NCT02233101|E1|Reported Event|Oral Tranexamic Acid|"Patients will receive either oral or intravenous Tranexamic Acid~Oral Tranexamic Acid: patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement"
649807|NCT02232880|B1|Baseline|Consented Patients|No patients received treatment prior to study termination
649808|NCT02232880|P1|Participant Flow|Consented Patients|
649809|NCT02232880|O1|Outcome|Consented Patients|
649810|NCT02232880|O1|Outcome|Consented Patients|
649811|NCT02232880|O1|Outcome|Consented Patients|
649812|NCT02232880|O1|Outcome|Consented Patients|
649813|NCT02232880|E1|Reported Event|Consented Patients|No patients received treatment prior to study termination
649814|NCT02232698|B3|Baseline|Total|Total of all reporting groups
649815|NCT02232698|B2|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649816|NCT02232698|B1|Baseline|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649817|NCT02232698|P2|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649818|NCT02232698|P1|Participant Flow|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
650473|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
649819|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649820|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649821|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
650086|NCT02230085|O1|Outcome|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
649822|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649823|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649824|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649825|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649826|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649827|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649828|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649829|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649830|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
653897|NCT02196077|E5|Reported Event|FF MDI 9.6 ug|FF MDI 9.6 ug
649831|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649832|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649833|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649834|NCT02232698|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649835|NCT02232698|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649836|NCT02232698|E2|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649837|NCT02232698|E1|Reported Event|Sensor Based Glucose Monitoring System|"Standard sensing system use for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
649838|NCT02232126|B3|Baseline|Total|Total of all reporting groups
649839|NCT02232126|B2|Baseline|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
649840|NCT02232126|B1|Baseline|Usual Care|Usual care consisted of the usual course of care provided to older adults transitioning home from a hospital stay at Huntington Memorial Hospital
649841|NCT02232126|P2|Participant Flow|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
649842|NCT02232126|P1|Participant Flow|Usual Care|
649843|NCT02232126|O2|Outcome|Intervention Group: Opt-outs|Patients randomized to the intervention group that refused the intervention.
649844|NCT02232126|O1|Outcome|Intervention Group: Received Intervention|Patients randomized to the intervention group and received the intervention. SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
649845|NCT02232126|O2|Outcome|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
649846|NCT02232126|O1|Outcome|Usual Care|Usual Care in the present study constitutes usual care that is delivered to older adults transitioning from the hospital to home from Huntington Memorial Hospital.
649847|NCT02232126|E2|Reported Event|Intervention|SWIFT home intervention: 1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
649848|NCT02232126|E1|Reported Event|Usual Care|Usual care for the present study constituted the usual course of care provided to older adults transitioning from hospital to home from Huntington Memorial Hospital.
649849|NCT02231918|B4|Baseline|Total|Total of all reporting groups
649850|NCT02231918|B3|Baseline|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649851|NCT02231918|B2|Baseline|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649852|NCT02231918|B1|Baseline|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649853|NCT02231918|P3|Participant Flow|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649854|NCT02231918|P2|Participant Flow|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649855|NCT02231918|P1|Participant Flow|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649856|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649857|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649858|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649859|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649860|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649861|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649863|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649864|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649865|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649866|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649867|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649868|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649869|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649870|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649871|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649872|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649873|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649874|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649875|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649876|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649877|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649878|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649879|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649880|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649881|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649882|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649883|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649884|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649885|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649886|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649887|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649888|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
650474|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
649889|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649890|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649891|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649892|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649893|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649894|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649895|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649896|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649897|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649898|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649899|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649900|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649901|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649902|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649903|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649904|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649905|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649906|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649907|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649908|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649909|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649910|NCT02231918|O3|Outcome|PPX (MIRAPEX®, 0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649911|NCT02231918|O2|Outcome|PPX (MIRAPEX®, 0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649912|NCT02231918|O1|Outcome|PPX (MIRAPEX®, 0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649913|NCT02231918|E3|Reported Event|MIRAPEX® (0.5 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.5 mg) tablet per day in evening with 240 mL of water in a fasting state.
649914|NCT02231918|E2|Reported Event|MIRAPEX® (0.25 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.25 mg) tablet per day in evening with 240 mL of water in a fasting state.
649915|NCT02231918|E1|Reported Event|MIRAPEX® (0.125 mg)|Orally administered single daily maintenance dose of MIRAPEX® (0.125 mg) tablet per day in evening with 240 mL of water in a fasting state.
649916|NCT02231177|B1|Baseline|All Subjects|"A randomised, active-controlled, double-blind, 3-way crossover study in patients with COPD (chronic obstructive pulmonary disease). All participants received each of the three treatment arms in a randomly assigned order, the three treatments, which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg.~Tiotropium 5 µg."
649917|NCT02231177|P6|Participant Flow|Tio 5 μg, Olo 10 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
649918|NCT02231177|P5|Participant Flow|Tio 5 μg, Tio+Olo 5/10 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol 10 µg."
649919|NCT02231177|P4|Participant Flow|Olo 10 μg, Tio 5 μg, Tio+Olo 5/10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Tiotropium 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg"
650268|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
649920|NCT02231177|P3|Participant Flow|Olo 10 μg, Tio+Olo 5/10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Olodaterol 10 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg."
649921|NCT02231177|P2|Participant Flow|Tio+Olo 5/10 μg, Tio 5 μg, Olo 10 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Tiotropium 5 µg.~Olodaterol 10 µg."
649922|NCT02231177|P1|Participant Flow|Tio+Olo 5/10 μg, Olo 10 μg, Tio 5 μg|"Patients received a total of three treatments, the treatments which were administered by oral inhalation, from the Respimat inhaler once daily, in the morning for 21 days, were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg~Olodaterol (Olo) 10 µg.~Tiotropium (Tio) 5 µg."
649923|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649924|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649925|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
650493|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
649926|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649927|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649928|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649929|NCT02231177|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649930|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649931|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649932|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649933|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649934|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649935|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649936|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649937|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649938|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649939|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649940|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649941|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649942|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649943|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649944|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649945|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649946|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649947|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649948|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649949|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649950|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649951|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649952|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649953|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649954|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649955|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649956|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649957|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649958|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649959|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649960|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649961|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649962|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649963|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649964|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649965|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649966|NCT02231177|O2|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649967|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649968|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649969|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649970|NCT02231177|O2|Outcome|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649971|NCT02231177|O1|Outcome|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649972|NCT02231177|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649973|NCT02231177|E2|Reported Event|Olodaterol 10 µg|Oral inhalation of Olodaterol 10 µg (5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649974|NCT02231177|E1|Reported Event|Tiotropium+Olodaterol 5/10 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning, for 21 days.
649975|NCT02231164|B3|Baseline|Total|Total of all reporting groups
649976|NCT02231164|B2|Baseline|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
649995|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
649977|NCT02231164|B1|Baseline|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
649978|NCT02231164|P2|Participant Flow|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
649979|NCT02231164|P1|Participant Flow|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
650002|NCT02230995|E1|Reported Event|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
649980|NCT02231164|O2|Outcome|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
649981|NCT02231164|O1|Outcome|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
649982|NCT02231164|E2|Reported Event|Nintedanib|Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
649983|NCT02231164|E1|Reported Event|Placebo|Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
649984|NCT02230995|B3|Baseline|Total|Total of all reporting groups
649985|NCT02230995|B2|Baseline|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
649986|NCT02230995|B1|Baseline|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
649987|NCT02230995|P2|Participant Flow|Fed 25mg+1000mg Single/FDC|"Subjects received in period 1 a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
649988|NCT02230995|P1|Participant Flow|Fed 25mg+1000mg FDC/Single|"Subjects received in period 1 a single dose of 25 mg empagliflozin/1000 mg metformin HCl XR (1 FDC tablet) with 240 mL of water after intake of a high-fat, high-caloric meal, followed in period 2 with a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.~2 treatments separated by a wash-out period of at least 7 days."
649989|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
649990|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
649991|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
649992|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
649993|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
649994|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
650157|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
653898|NCT02196077|E4|Reported Event|BD MDI 320 ug|BD MDI 320 ug
649996|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
649997|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
649998|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
649999|NCT02230995|O2|Outcome|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
650000|NCT02230995|O1|Outcome|Fed 25mg+1000mg FDC|Subjects received a single dose of 25 mg empagliflozin/1000 mg metformin Hydrochloride (HCl) Extended release (XR) (1 Fixed dose combination (FDC) tablet) with 240 mL of water after intake of a high-fat, high-caloric meal.
650001|NCT02230995|E2|Reported Event|Fed 25mg+1000mg Single|Subject received a single dose of 25 mg empagliflozin (1 tablet) together with 1000 mg metformin HCl XR (2 tablets) with 240 mL of water after intake of a high-fat, high-caloric meal.
650005|NCT02230956|B2|Baseline|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650006|NCT02230956|B1|Baseline|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650007|NCT02230956|P3|Participant Flow|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
650008|NCT02230956|P2|Participant Flow|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650009|NCT02230956|P1|Participant Flow|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650010|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
650011|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650012|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650013|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
650014|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650015|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650016|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
650017|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650018|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650019|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
650020|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650021|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650022|NCT02230956|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
650023|NCT02230956|O2|Outcome|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650024|NCT02230956|O1|Outcome|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650025|NCT02230956|E3|Reported Event|Placebo|Placebo (Normal Saline) injection into the intra-articular space of the study knee on Day 1.
650026|NCT02230956|E2|Reported Event|OnabotulinumtoxinA 200 U|OnabotulinumtoxinA 200 U injection into the intra-articular space of the study knee on Day 1.
650027|NCT02230956|E1|Reported Event|OnabotulinumtoxinA 400 U|OnabotulinumtoxinA 400 U injection into the intra-articular space of the study knee on Day 1.
650028|NCT02230904|B3|Baseline|Total Title|
650029|NCT02230904|B2|Baseline|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
650030|NCT02230904|B1|Baseline|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
650031|NCT02230904|P2|Participant Flow|Treatment Arm B-A|4 day treatment (Treatment B for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 followed by Treatment A for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1)
650032|NCT02230904|P1|Participant Flow|Treatment Arm A-B|4 day treatment (Treatment A for 2 days (Day 1 and Day 2): Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 followed by Treatment B for 2 days (Day 3 and Day 4): Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1)
650033|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
650222|NCT02229318|P1|Participant Flow|FruitiVits|Daily administration of FruitiVits dietary supplement
650034|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
650035|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
650036|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
650037|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
650038|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
650039|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
650040|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
650041|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
650042|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
650043|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
650044|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
650045|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1
650046|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1
650047|NCT02230904|O2|Outcome|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
650048|NCT02230904|O1|Outcome|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
650049|NCT02230904|E2|Reported Event|Treatment B|Rotigotine transdermal patch 8 mg/24 hours reference product PR 2.1.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence B-A and Day 3 and Day 4 for subjects in Treatment Sequence A-B).
650050|NCT02230904|E1|Reported Event|Treatment A|Rotigotine transdermal patch 8 mg/24 hours, test product PR 2.3.1 for 2 days (Day 1 and Day 2 for subjects in Treatment Sequence A-B and Day 3 and Day 4 for subjects in Treatment Sequence B-A).
650051|NCT02230761|B3|Baseline|Total|Total of all reporting groups
650052|NCT02230761|B2|Baseline|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
650053|NCT02230761|B1|Baseline|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
650054|NCT02230761|P2|Participant Flow|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
650055|NCT02230761|P1|Participant Flow|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
650056|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
650057|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
650058|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
650059|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
650060|NCT02230761|O2|Outcome|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
650061|NCT02230761|O1|Outcome|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
650062|NCT02230761|E2|Reported Event|Placebo Ointment|"Placebo is an ointment that matches XOPH5 Ointment but lacks the active ingredient.~Placebo"
650063|NCT02230761|E1|Reported Event|XOPH5 Ointment|"XOPH5 Ointment is the investigational drug to be studied.~XOPH5 Ointment"
650064|NCT02230683|B1|Baseline|IDN-6556|IDN-6556 25 mg Dosed twice daily
650065|NCT02230683|P1|Participant Flow|IDN-6556|IDN-6556 25 mg Dosed twice daily
650066|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
650067|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
650068|NCT02230683|O1|Outcome|IDN-6556|Overall evaluable population treated with IDN-6556 25 mg twice daily
650069|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
650070|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
650071|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
650072|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with Baseline HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
650073|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with Baseline HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
650074|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily
650075|NCT02230683|O3|Outcome|IDN-6556 - Subgroup HVPG ≥ 12 mmHg|Subgroup for patients with HVPG ≥ 12 mmHg that have been treated with IDN-6556 25 mg twice daily
650076|NCT02230683|O2|Outcome|IDN-6556 - Subgroup With HVPG < 12 mmHg|Subgroup for patients with HVPG < 12 mmHg that have been treated with IDN-6556 25 mg twice daily
650077|NCT02230683|O1|Outcome|IDN-6556 - Overall Population|Overall evaluable population treated with IDN-6556 25 mg twice daily with HVPG measurement at Baseline and Day 28
650078|NCT02230683|E1|Reported Event|IDN-6556|IDN-6556 25 mg Dosed twice daily
650079|NCT02230540|B1|Baseline|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
650223|NCT02229318|O1|Outcome|FruitiVits|Administration of FruitiVits dietary supplement
650224|NCT02229318|O1|Outcome|FruitiVits|Daily administration of FruitiVits dietary supplement
650080|NCT02230540|P2|Participant Flow|Sequence B|"Based on results from sequence A, sequence B may or may not be initiated.~Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product B in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product B SelfCath and urine bag, Conveen Contour: SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices)."
650081|NCT02230540|P1|Participant Flow|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions. Measurement of residual urine at different positions.~SelfCath (comparator): Commercially available CE-marked catheter for urinary drainage.~Product A SelfCath and urine bag, Conveen Security+: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
650082|NCT02230540|O1|Outcome|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
650083|NCT02230540|E1|Reported Event|Sequence A|"Catheterization with SelfCath (comparator) followed by measurement of residual urine.~Then catheterization with Product A in different positions and measurement of residual urine.~SelfCath (comparator): Catheter for urinary drainage.~Product A: SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices)."
650084|NCT02230085|B1|Baseline|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
650085|NCT02230085|P1|Participant Flow|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
650087|NCT02230085|E1|Reported Event|CPAP Therapy|Administration of the questionnaire and monitoring of CPAP adherence
650088|NCT02229864|B1|Baseline|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
650089|NCT02229864|P1|Participant Flow|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
650090|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650091|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650092|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650093|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650094|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650095|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650096|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650097|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650098|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650099|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650100|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650101|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650102|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650103|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650104|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650105|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650225|NCT02229318|E1|Reported Event|FruitiVits|Daily administration of FruitiVits dietary supplement
650106|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650107|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650108|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650109|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650110|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650111|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650112|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650318|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650113|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650114|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650115|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650116|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650117|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650118|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650119|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650120|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650121|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650122|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650123|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650124|NCT02229864|O1|Outcome|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS).~Absorb BVS with the diameters of 2.5, 3.0 and 3.5 mm and lengths of 8, 12, 18 and 28 mm. The total everolimus dose ranged from 181 μg to 443 μg."
650125|NCT02229864|E1|Reported Event|Coronary Artery Stenting: Absorb BVS|"Subjects receiving Absorb Bioresorbable Vascular Scaffold (BVS)~Coronary artery stenting: Absorb BVS: • Scaffold diameters: 2.5, 3.0 and 3.5 mm~• Scaffold lengths: 8, 12, 18, and 28 mm"
650126|NCT02229539|B4|Baseline|Total|Total of all reporting groups
650127|NCT02229539|B3|Baseline|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650128|NCT02229539|B2|Baseline|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650129|NCT02229539|B1|Baseline|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650130|NCT02229539|P3|Participant Flow|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650131|NCT02229539|P2|Participant Flow|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650132|NCT02229539|P1|Participant Flow|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650226|NCT02229214|B3|Baseline|Total|Total of all reporting groups
650227|NCT02229214|B2|Baseline|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
650133|NCT02229539|O3|Outcome|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650134|NCT02229539|O2|Outcome|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650135|NCT02229539|O1|Outcome|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650136|NCT02229539|E3|Reported Event|Placebo|Patients receive 2.5 mL placebo and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650137|NCT02229539|E2|Reported Event|DLA (Diphenhydramine, Lidocaine and Antacid)|Patients receive 5.0 mL DLA orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650138|NCT02229539|E1|Reported Event|Doxepin|Patients receive 2.5 mL (25 mg) doxepin and 2.5 mL water orally in the clinic on Day 1 (Cycle 1). Patients will be encouraged to continue treatment with the study agent for an additional week (Cycle 2).
650139|NCT02229513|B3|Baseline|Total|Total of all reporting groups
650203|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650140|NCT02229513|B2|Baseline|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650141|NCT02229513|B1|Baseline|Control|Normal cesarean technique.
650142|NCT02229513|P2|Participant Flow|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650143|NCT02229513|P1|Participant Flow|Control|Normal cesarean technique.
650144|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650145|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650146|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650147|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650148|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650149|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650150|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650151|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650152|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650153|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650154|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650155|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650156|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650158|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650159|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650160|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650161|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650204|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650162|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650163|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650164|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650165|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650166|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650167|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650168|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650169|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650170|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650171|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650172|NCT02229513|O2|Outcome|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650173|NCT02229513|O1|Outcome|Control|Normal cesarean technique.
650174|NCT02229513|E2|Reported Event|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
650175|NCT02229513|E1|Reported Event|Control|Normal cesarean technique.
650176|NCT02229461|B8|Baseline|Total|Total of all reporting groups
650177|NCT02229461|B7|Baseline|Non-Randomized|Fifteen participants were not randomized into Treatment Period.
650178|NCT02229461|B6|Baseline|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650179|NCT02229461|B5|Baseline|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650180|NCT02229461|B4|Baseline|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650266|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650181|NCT02229461|B3|Baseline|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650182|NCT02229461|B2|Baseline|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650183|NCT02229461|B1|Baseline|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650235|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
650319|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650184|NCT02229461|P6|Participant Flow|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650185|NCT02229461|P5|Participant Flow|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650186|NCT02229461|P4|Participant Flow|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650187|NCT02229461|P3|Participant Flow|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650188|NCT02229461|P2|Participant Flow|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650189|NCT02229461|P1|Participant Flow|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650190|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650191|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650192|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650193|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650194|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650195|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650196|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650197|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650198|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650199|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650200|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650267|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650201|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650202|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650236|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650205|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650206|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650207|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650208|NCT02229461|O6|Outcome|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650209|NCT02229461|O5|Outcome|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650210|NCT02229461|O4|Outcome|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650211|NCT02229461|O3|Outcome|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650212|NCT02229461|O2|Outcome|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650213|NCT02229461|O1|Outcome|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650214|NCT02229461|E7|Reported Event|Group 6-IR ASA 30 Min After First Dose of Naproxen Sodium Bid|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650215|NCT02229461|E6|Reported Event|Group 5-IR ASA 30 Min Before Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650216|NCT02229461|E5|Reported Event|Group 4-IR ASA Only|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650217|NCT02229461|E4|Reported Event|Group 3-IR ASA 8 Hours After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650218|NCT02229461|E3|Reported Event|Group 2-IR ASA 30 Min After Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650219|NCT02229461|E2|Reported Event|Group 1-IR ASA Co-administered With Naproxen Sodium|Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
650220|NCT02229461|E1|Reported Event|Group 0-IR ASA 81 mg qd in Run-in Period|Participants, subsequently randomized to treatment period, were administered the first dose of immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily at the clinical study site and instructed to take the remaining 5 doses in a fasted state with a full glass of water once daily in the morning in an outpatient setting.
650221|NCT02229318|B1|Baseline|FruitiVits|Daily administration of FruitiVits dietary supplement
650228|NCT02229214|B1|Baseline|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650229|NCT02229214|P2|Participant Flow|Placebo|"Days 1-28: Placebo~Sugar Pill"
650230|NCT02229214|P1|Participant Flow|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650231|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
650232|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650233|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Placebo (sugar pill)"
650234|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650238|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650239|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
650240|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650241|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
650242|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650243|NCT02229214|O2|Outcome|Sugar Pill|"Days 1-28: Placebo~Placebo"
650244|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650245|NCT02229214|O2|Outcome|Placebo|"Days 1-28: Placebo~Sugar Pill"
650246|NCT02229214|O1|Outcome|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650247|NCT02229214|E2|Reported Event|Placebo|"Days 1-28: Placebo~Sugar Pill"
650248|NCT02229214|E1|Reported Event|VI-0521 (Qsymia)|"Days 1-3: VI-0521 (Phentermine/Topiramate 3.75 mg/23 mg)~Days 4-6: VI-0521 (Phentermine/Topiramate 7.5 mg/46 mg)~Days 7-9: VI-0521 (Phentermine/Topiramate 11.25 mg/69 mg)~Days 10-28: VI-0521 (Phentermine/Topiramate 15 mg/92 mg)~Qsymia"
650249|NCT02228980|B5|Baseline|Total|Total of all reporting groups
650250|NCT02228980|B4|Baseline|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650251|NCT02228980|B3|Baseline|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650252|NCT02228980|B2|Baseline|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650253|NCT02228980|B1|Baseline|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
650254|NCT02228980|P4|Participant Flow|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650255|NCT02228980|P3|Participant Flow|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650256|NCT02228980|P2|Participant Flow|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650257|NCT02228980|P1|Participant Flow|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
650258|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650259|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650260|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650261|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
650262|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650263|NCT02228980|O3|Outcome|Age 18 to 60 Years Group|Participants 18 to 60 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650264|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650265|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
650466|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650269|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
650270|NCT02228980|O4|Outcome|Age ≥61 Years Group|Participants ≥61 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650271|NCT02228980|O3|Outcome|Age 8 to 60 Years Group|Participants 18 to 60 years of age received a single 0.5 mL dose of trivalent influenza vaccine (split-virion, inactivated).
650272|NCT02228980|O2|Outcome|Age 3 to 17 Years Group|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
650273|NCT02228980|O1|Outcome|Age 6 to 35 Months Group|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
650274|NCT02228980|E4|Reported Event|Group 4|Participants ≥61 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
650275|NCT02228980|E3|Reported Event|Group 3|Participants 18 to 60 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
650276|NCT02228980|E2|Reported Event|Group 2|Participants 3 to 17 years of age received a single 0.5-mL dose of trivalent influenza vaccine (split-virion, inactivated).
650277|NCT02228980|E1|Reported Event|Group 1|Participants 6 to 35 months of age received two 0.25 mL doses of trivalent influenza vaccine (split-virion, inactivated) given 28 days apart.
650278|NCT02228395|B1|Baseline|All Participants|Included all participants who received at least 1 dose of study treatment in any of the intervention periods
650279|NCT02228395|P3|Participant Flow|PF-04958242 0.35 mg, PF-04958242 0.6 mg, Placebo|Participants received 1 single dose of PF-04958242 0.35 mg, PF-04958242 0.6 mg, and placebo orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
650280|NCT02228395|P2|Participant Flow|PF-04958242 0.35 mg, Placebo, PF-04958242 0.8 mg|Participants received 1 single dose of PF-04958242 0.35 mg, placebo, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
650281|NCT02228395|P1|Participant Flow|Placebo, PF-04958242 0.6 Milligrams (mg), PF-04958242 0.8 mg|Participants received 1 single dose of placebo, PF-04958242 0.6 mg, and PF-04958242 0.8 mg orally during 3 periods, respectively. There was at least a 10-day washout period between each dosing.
650282|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650283|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650284|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650285|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650286|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650287|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650288|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650289|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650290|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650291|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650292|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650293|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650294|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650295|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650296|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650297|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650298|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650299|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650300|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650301|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650302|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650303|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650304|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650305|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650306|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650307|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650308|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650309|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650310|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650311|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650312|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650313|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650314|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650315|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650316|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650317|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650494|NCT02226198|O2|Outcome|Maintenance Phase|Measurement taken after 6 weeks active treatment (rosuvastatin) in the maintenance phase.
650320|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650321|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650322|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650323|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650324|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650325|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650326|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650327|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650328|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650329|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650330|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650331|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650332|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650333|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650334|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650335|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650336|NCT02228395|O4|Outcome|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650337|NCT02228395|O3|Outcome|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650338|NCT02228395|O2|Outcome|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650339|NCT02228395|O1|Outcome|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650340|NCT02228395|E4|Reported Event|Placebo|All participants who received a single-dose of placebo matching capsule orally in any of the intervention periods.
650341|NCT02228395|E3|Reported Event|PF-04958242 0.8 mg|All participants who received a single-dose of PF-04958242 0.8 mg capsule orally in any of the intervention periods.
650342|NCT02228395|E2|Reported Event|PF-04958242 0.6 mg|All participants who received a single-dose of PF-04958242 0.6 mg capsule orally in any of the intervention periods.
650343|NCT02228395|E1|Reported Event|PF-04958242 0.35 mg|All participants who received a single-dose of PF-04958242 0.35 mg capsule orally in any of the intervention periods.
650344|NCT02227810|B3|Baseline|Total|Total of all reporting groups
650345|NCT02227810|B2|Baseline|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
650346|NCT02227810|B1|Baseline|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
650467|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650347|NCT02227810|P2|Participant Flow|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
650348|NCT02227810|P1|Participant Flow|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
650349|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
650350|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
650351|NCT02227810|O2|Outcome|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
650352|NCT02227810|O1|Outcome|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
650579|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
650353|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
650354|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
650355|NCT02227810|O2|Outcome|Electrical Stimulation|"Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (high frequency): Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days~electrical stimulation (low frequency): Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days."
650356|NCT02227810|O1|Outcome|Sham Group|"Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.~sham group: Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off."
650357|NCT02227810|E2|Reported Event|Electrical Stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle for 20 min/session, twice daily for 10 days
650358|NCT02227810|E1|Reported Event|Sham Group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
650359|NCT02227485|B3|Baseline|Total|Total of all reporting groups
650360|NCT02227485|B2|Baseline|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patients in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650361|NCT02227485|B1|Baseline|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patients in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650362|NCT02227485|P2|Participant Flow|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650363|NCT02227485|P1|Participant Flow|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650364|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650365|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650366|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650468|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650469|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650367|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650368|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650369|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650370|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650400|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650371|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650372|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650373|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650374|NCT02227485|O2|Outcome|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650375|NCT02227485|O1|Outcome|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650376|NCT02227485|E2|Reported Event|Punica Granatum Pleniflora Mouth Rinse|"Punica granatum Pleniflora (Golnaar) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Punica granatum Pleniflora (Golnaar) mouth rinse: All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650377|NCT02227485|E1|Reported Event|Chlorhexidine (0.2%)|"Chlorhexidine (0.2%) mouth rinse, 10 ml for 2 minutes every night for 2 weeks and tooth bleaching (one time) after using mouth rinse.~Chlorhexidine (0.2%): All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.~Tooth bleaching: Tooth bleaching for both groups one time after using mouth rinses."
650378|NCT02227368|B3|Baseline|Total|Total of all reporting groups
650379|NCT02227368|B2|Baseline|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
650380|NCT02227368|B1|Baseline|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
650381|NCT02227368|P2|Participant Flow|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
650382|NCT02227368|P1|Participant Flow|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
650383|NCT02227368|O2|Outcome|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
650384|NCT02227368|O1|Outcome|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
650385|NCT02227368|O2|Outcome|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
650386|NCT02227368|O1|Outcome|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
650387|NCT02227368|E2|Reported Event|Aspirin|Aspirin 100mg once daily plus ticagrelor placebo twice a day
650388|NCT02227368|E1|Reported Event|Ticagrelor|Ticagrelor 90mg twice a day plus aspirin placebo once daily
650389|NCT02227121|B1|Baseline|Enrolled Subjects|All subjects consented for the study.
650390|NCT02227121|P1|Participant Flow|Enrolled Subjects|All subjects consented for the study.
650391|NCT02227121|O1|Outcome|VF Induction and Defibrillation|"Ventricular Fibrillation (VF) induction and defibrillation will be carried out as the invention in all subjects undergoing study procedures.~Defibrillation following induction of VF: Up to 10 VF induction attempts followed by shock(s) delivered by an externally placed Implantable Cardioverter/Defibrillator (ICD) and/or external defibrillator."
650392|NCT02227121|E1|Reported Event|Enrolled Subjects|All subjects consented into the study
650393|NCT02227108|B1|Baseline|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650394|NCT02227108|P1|Participant Flow|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650470|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650395|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650396|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650397|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650398|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650399|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650490|NCT02226198|O1|Outcome|Lead-in|Optional 10mg lead-in phase, Safety analysis set
650401|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650402|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650403|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650404|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650405|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650406|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650407|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650408|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650409|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650410|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650411|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650412|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650413|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650414|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650415|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650416|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650417|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650471|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650418|NCT02227108|O1|Outcome|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650419|NCT02227108|E1|Reported Event|Moxetumomab Pasudotox 40 Microgram Per Kilogram (mcg/kg)|Participants received 6 doses of moxetumomab pasudotox 40 mcg/kg intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
650420|NCT02226562|B3|Baseline|Total|Total of all reporting groups
650421|NCT02226562|B2|Baseline|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650422|NCT02226562|B1|Baseline|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650423|NCT02226562|P2|Participant Flow|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650424|NCT02226562|P1|Participant Flow|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650425|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650426|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650427|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650428|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650429|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650430|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650431|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650432|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650433|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650434|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650435|NCT02226562|O2|Outcome|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650436|NCT02226562|O1|Outcome|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650437|NCT02226562|E2|Reported Event|Dentifrice Alone|Dentifrice containing 1000 parts per million (ppm) fluoride as sodium monofluorophosphate (SMFP)
650438|NCT02226562|E1|Reported Event|Dentifrice Plus Oral Rinse|3.0% weight by weight (w/w) potassium nitrate oral rinse with 0.02% sodium fluoride dentifrice
650439|NCT02226549|B3|Baseline|Total|Total of all reporting groups
650440|NCT02226549|B2|Baseline|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
650441|NCT02226549|B1|Baseline|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
650442|NCT02226549|P2|Participant Flow|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
650443|NCT02226549|P1|Participant Flow|LDV/SOF+VDV|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet + vedroprevir (VDV) 80 mg tablet once daily for 8 weeks
650444|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
650445|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
650446|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
650447|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
650448|NCT02226549|O2|Outcome|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
650449|NCT02226549|O1|Outcome|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
650450|NCT02226549|E2|Reported Event|LDV/SOF+VDV+RBV|LDV/SOF (90/400 mg) FDC tablet once daily + VDV 80 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
650451|NCT02226549|E1|Reported Event|LDV/SOF+VDV|LDV/SOF (90/400 mg) FDC tablet + VDV 80 mg tablet once daily for 8 weeks
650452|NCT02226198|B1|Baseline|Cross-over|Cross-over phase
650453|NCT02226198|P3|Participant Flow|Placebo First Then Rosuva|Relevant for the cross-over phase
650454|NCT02226198|P2|Participant Flow|Rosuva First Then Placebo|Relevant for the cross-over phase
650455|NCT02226198|P1|Participant Flow|Overall|Relevant for the lead-in and maintenance phases
650456|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
650457|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
650458|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
650459|NCT02226198|O3|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650460|NCT02226198|O2|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650461|NCT02226198|O1|Outcome|Safety Analysis Set|Safety Analysis Set
650462|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
650463|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting crossover-phase with 6 weeks of rosuvastatin
650464|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650465|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650475|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650476|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
650477|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
650478|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
650479|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
650480|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
650481|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
650482|NCT02226198|O2|Outcome|Pla/Ros|Safety Analysis Set, starting crossover-phase with 6 weeks of placebo
650483|NCT02226198|O1|Outcome|Ros/Pla|Safety Analysis Set, starting cross-over with 6 weeks of rosuvastatin
650484|NCT02226198|O4|Outcome|Pla/Ros >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
650485|NCT02226198|O3|Outcome|Pla/Ros <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of placebo
650486|NCT02226198|O2|Outcome|Ros/Pla >ULN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
650487|NCT02226198|O1|Outcome|Ros/Pla <LLN|Safety Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
650488|NCT02226198|O3|Outcome|Maintenance Phase|Maintenance phase, Safety analysis set
650489|NCT02226198|O2|Outcome|Cross-over Phase|Cross-over phase, Safety analysis set
650495|NCT02226198|O1|Outcome|Cross-over Phase|Measurements taken after 6 weeks active treatment (rosuvastatin) in the cross-over phase
650496|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
650497|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
650498|NCT02226198|O2|Outcome|M-FAS Placebo|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of placebo
650499|NCT02226198|O1|Outcome|M-FAS Rosuvastatin|Maintenance Full Analysis Set, starting cross-over phase with 6 weeks of rosuvastatin
650500|NCT02226198|O2|Outcome|C-FAS Placebo Not on Apheresis|Cross-over Full Analysis Set, 6 weeks of Placebo
650501|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650502|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650503|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650504|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650505|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650506|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650507|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650508|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650509|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650510|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650511|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650512|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650513|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650514|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650515|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650516|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650517|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650518|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650519|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650520|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650521|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650522|NCT02226198|O2|Outcome|C-FAS Placebo|Cross-over Full Analysis Set, 6 weeks of Placebo
650523|NCT02226198|O1|Outcome|C-FAS Rosuvastatin|Cross-over Full Analysys Set, 6 weeks of Rosuvastatin
650524|NCT02226198|E3|Reported Event|Maintenance|Maintenance phase
650525|NCT02226198|E2|Reported Event|Cross-over|Cross-over phase
650526|NCT02226198|E1|Reported Event|Lead-in|Lead-in
650527|NCT02226003|B4|Baseline|Total|Total of all reporting groups
650528|NCT02226003|B3|Baseline|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650529|NCT02226003|B2|Baseline|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650530|NCT02226003|B1|Baseline|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650531|NCT02226003|P3|Participant Flow|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650782|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650532|NCT02226003|P2|Participant Flow|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650533|NCT02226003|P1|Participant Flow|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650534|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650535|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650536|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650537|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650538|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650539|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650540|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650541|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650542|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650543|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650544|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650545|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650546|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650547|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650548|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650549|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650550|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650551|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650552|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650553|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650554|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650555|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650556|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650557|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650558|NCT02226003|O3|Outcome|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650559|NCT02226003|O2|Outcome|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650560|NCT02226003|O1|Outcome|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650561|NCT02226003|E3|Reported Event|Placebo|Placebo to ertugliflozin, 5 mg and 10 mg, administered orally, once daily for 26 weeks. Placebo to sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650562|NCT02226003|E2|Reported Event|Ertugliflozin 15 mg + Sitagliptin 100 mg|Ertugliflozin, 15 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
650563|NCT02226003|E1|Reported Event|Ertugliflozin 5 mg + Sitagliptin 100 mg|Ertugliflozin, 5 mg, administered orally, once daily for 26 weeks. Sitagliptin, 100 mg, administered orally, once daily for 26 weeks. Placebo to ertugliflozin, 10 mg, administered orally, once daily for 26 weeks.
650564|NCT02225860|B3|Baseline|Total|Total of all reporting groups
650565|NCT02225860|B2|Baseline|Control|Continue with usual diet
650566|NCT02225860|B1|Baseline|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
650567|NCT02225860|P2|Participant Flow|Control|Continue with usual diet
650568|NCT02225860|P1|Participant Flow|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
650569|NCT02225860|O2|Outcome|Control|Continue with usual diet
650570|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment: The dietary intervention consisted of three elements: low sodium (1500 mg/day), low protein (daily protein dietary allowance of 0.8 gram/kg body weight), and low urea (avoidance of preservatives, food additives, bulking agents, and chewing gum). Protein was factored by measured body weight to mirror the estimated average requirement (EAR) of healthy adults which is set on a grams per kilogram basis"
650571|NCT02225860|O2|Outcome|Control|Continue with usual diet
650572|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
650573|NCT02225860|O2|Outcome|Control|Continue with usual diet
650574|NCT02225860|O1|Outcome|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
650575|NCT02225860|E2|Reported Event|Control|Continue with usual diet
650576|NCT02225860|E1|Reported Event|Diet and Water Adjustment|"Reduction in dietary salt and protein intake~Diet and water adjustment"
650577|NCT02224820|B1|Baseline|Intravenous IdeS|"One or two doses of IdeS in ascending doses~IdeS"
650578|NCT02224820|P1|Participant Flow|Intravenous IdeS|One or two doses of IdeS in ascending doses.
650580|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
650581|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
650582|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
650583|NCT02224820|O1|Outcome|Intravenous IdeS|One or two doses of IdeS in ascending doses.
650584|NCT02224820|E1|Reported Event|Intravenous IdeS|One or two doses of IdeS in ascending doses.
650585|NCT02224664|B1|Baseline|Overall Study|All participants who received a single oral dose of L-Dopa tablet/capsule (up to a maximum dose of 250 mg, based on investigator’s discretion) in lead-in period and/or single oral dose of PF-06649751 tablet (3 mg, 5 mg, 15 mg and 25 mg) in dose escalation period.
650586|NCT02224664|P5|Participant Flow|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650587|NCT02224664|P4|Participant Flow|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650588|NCT02224664|P3|Participant Flow|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650589|NCT02224664|P2|Participant Flow|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650590|NCT02224664|P1|Participant Flow|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650591|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650592|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650593|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650594|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650595|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650596|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650597|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
653899|NCT02196077|E3|Reported Event|BFF MDI 80/9.6 ug|BFF MDI 80/9.6 ug
650598|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650599|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650600|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650601|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650602|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650603|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650604|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650723|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650605|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650606|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650607|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650608|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650609|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650610|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650611|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650612|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650613|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650614|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650615|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650616|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650617|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650618|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650619|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650620|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650708|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650621|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650622|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650623|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650624|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650625|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650626|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650627|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
654477|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
650628|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650629|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650630|NCT02224664|O4|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650631|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650632|NCT02224664|O2|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650633|NCT02224664|O1|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650634|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650635|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650636|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650637|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650638|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650639|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650640|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650641|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650642|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650709|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
651558|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
650643|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650644|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650645|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650646|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650647|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650648|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650649|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
653395|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
650650|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650651|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650652|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650653|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650654|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650655|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650656|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650657|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650658|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650659|NCT02224664|O5|Outcome|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650660|NCT02224664|O4|Outcome|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
650661|NCT02224664|O3|Outcome|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650662|NCT02224664|O2|Outcome|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650663|NCT02224664|O1|Outcome|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650664|NCT02224664|E5|Reported Event|PF-06649751 25 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 25 mg.
650665|NCT02224664|E4|Reported Event|PF-06649751 15 mg + L-Dopa: L-dopa Induced Dyskinesia (LID)|Participants with LID received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1 mg up to a maximum dose level of 15 mg.
653900|NCT02196077|E2|Reported Event|BFF MDI 160/9.6 ug|BFF MDI 160/9.6 ug
650666|NCT02224664|E3|Reported Event|PF-06649751 15 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 1.0 mg up to a maximum dose of 15 mg.
650667|NCT02224664|E2|Reported Event|PF-06649751 5 mg + L-Dopa|Participants received a single oral tablet of PF-06649751 once daily along with L-Dopa oral tablets (dose of L-Dopa was based on investigator’s decision) from Day 3 up to Day 23 in Period 2. Dose levels were titrated from 0.25 mg up to a maximum dose level of 5 mg.
650668|NCT02224664|E1|Reported Event|L-Dopa|Participants received a single oral tablet/capsule of L-Dopa on Day 1 of first intervention period. Dose ranges from 50 milligram (mg) up to a maximum dose of 250 mg, based on investigator’s discretion in Period 1.
650669|NCT02224625|B1|Baseline|2% CHG, Vehicle, DynaHex, Saline|Chlorhexidine Gluconate 2% Cloth Solution Vehicle solution of CHG cloth DynaHex 2% CHG solution 0.9% Saline Sodium Lauryl Sulfate (only used in Irritation Study)
650670|NCT02224625|P1|Participant Flow|2% CHG Cloth, Vehicle, DynaHex, Saline, SLS|Chlorhexidine Gluconate 2% cloth solution Vehicle solution of 2% CHG cloth DynaHex (2% CHG) 0.9% Saline Sodium Lauryl Sulfate
650671|NCT02224625|O5|Outcome|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
650672|NCT02224625|O4|Outcome|Saline|"0.9% sodium chloride~Saline: Negative control"
650673|NCT02224625|O3|Outcome|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
650674|NCT02224625|O2|Outcome|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
650675|NCT02224625|O1|Outcome|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
653396|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
650676|NCT02224625|E5|Reported Event|Sodium Lauryl Sulfate (SLS)|"Sodium lauryl sulfate to produce mild irritation as a positive control~SLS: Provides a slight irritation for a positive control"
650677|NCT02224625|E4|Reported Event|Saline|"0.9% sodium chloride~Saline: Negative control"
650678|NCT02224625|E3|Reported Event|DynaHex (2% CHG)|"Chlorhexidine Gluconate 2% solution~Active Comparator: 2% CHG solution"
650679|NCT02224625|E2|Reported Event|Vehicle Cloth|"Excipients on cloth~Vehicle Cloth: Excipients from CHG cloth only"
650680|NCT02224625|E1|Reported Event|2% CHG Cloth|"Chlorhexidine Gluconate 2%~2% CHG Cloth: CHG solution on cloth"
650681|NCT02224508|B3|Baseline|Total|Total of all reporting groups
650682|NCT02224508|B2|Baseline|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
650683|NCT02224508|B1|Baseline|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
650684|NCT02224508|P2|Participant Flow|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
650685|NCT02224508|P1|Participant Flow|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
650686|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
650687|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
650688|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
650689|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiative for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
650690|NCT02224508|O2|Outcome|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
650691|NCT02224508|O1|Outcome|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
650692|NCT02224508|E2|Reported Event|Usual Care|Usual care for management of chronic opioid therapy patients implemented in Group Health network care settings.
650693|NCT02224508|E1|Reported Event|Opioid Risk Reduction Initiative|Opioid risk reduction initiatives (dose reduction and then risk stratification and monitoring) for chronic opioid therapy patients implemented in Group Health integrated group practice clinics.
650694|NCT02224404|B1|Baseline|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
650695|NCT02224404|P1|Participant Flow|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
650696|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
650697|NCT02224404|O1|Outcome|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
650698|NCT02224404|E1|Reported Event|Fast Gelling Dressing|Fast Gelling Dressing (Exufiber)
650699|NCT02224053|B1|Baseline|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
650700|NCT02224053|P1|Participant Flow|AZD9291 and Omeprazole|Sequential treatments periods of AZD9291 + omeprazole (including a washout) followed by AZD9291 alone.
650701|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650702|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650703|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650704|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650705|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650706|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650707|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650779|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650710|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650711|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650712|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650713|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650714|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650715|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650716|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650717|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650718|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650719|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650720|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650721|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650722|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650724|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650725|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650726|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650727|NCT02224053|O2|Outcome|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650728|NCT02224053|O1|Outcome|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650729|NCT02224053|E2|Reported Event|AZD9291 Alone|AZD9291 80 mg single oral dose on Day 1 (Period 2)
650730|NCT02224053|E1|Reported Event|AZD9291 and Omeprazole Co-administration|Once daily dosing of omeprazole 40 mg on Days 1 to 5 and AZD9291 80 mg single oral dose on Day 5 (Period 1).
650731|NCT02223871|B1|Baseline|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes occurred 16 days after ACT-451840 administration (or earlier if required).
650732|NCT02223871|P1|Participant Flow|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650733|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650734|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650735|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650736|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650737|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650738|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650780|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650781|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
653901|NCT02196077|E1|Reported Event|BFF MDI 320/9.6 ug|BFF MDI 320/9.6 ug
650739|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650740|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650741|NCT02223871|O1|Outcome|ACT-451840 500 mg|The subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes. When the parasitemia reached 1000 counts/mL, the subjects received 500 mg of ACT-451840 as an oral single dose. Compulsory commencement of treatment with Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, occurred 16 days after ACT-451840 administration (or earlier if required).
650742|NCT02223871|E1|Reported Event|ACT-451840 500 mg|The eight subjects were infected with Plasmodium falciparum parasites (malaria) using malaria-infected human erythrocytes on Day 0 and received 500 mg of ACT-451840 on Day 7. All of them received six doses of Riamet® (artemether-lumefantrine) to ensure complete clearance of any gametocytes, as per protocol.
650743|NCT02223754|B3|Baseline|Total|Total of all reporting groups
650744|NCT02223754|B2|Baseline|Lotrafilcon B / Etafilcon A|Subjects that were randomized to this sequence and were dispensed a study lens.
653397|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
650745|NCT02223754|B1|Baseline|Etafilcon A / Lotrafilcon B|Subjects that were randomized to this sequence and were dispensed a study lens.
650746|NCT02223754|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomized to one of two lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
650747|NCT02223754|P1|Participant Flow|Etafilcon A / Lotrafilcon B|Subjects were randomized to one of two lens sequences. Subjects first received the etafilcon A contact lens and then received the Control lens (lotrafilcon B contact lens.
650748|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
650749|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650750|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
650751|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650752|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
650753|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650754|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
650755|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650756|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
650757|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650758|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
650759|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650760|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B during either the first or second period of the study.
650761|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650762|NCT02223754|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
650763|NCT02223754|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650764|NCT02223754|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens during either the first or second period of the study.
650765|NCT02223754|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A contact lens during either the first or second period of the study.
650766|NCT02223715|B1|Baseline|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
650767|NCT02223715|P1|Participant Flow|Clostridium Difficile Infection|To characterize the ｍanagement and outcome of Clostridium Difficile Infection in asian pacific countries
650768|NCT02223715|O1|Outcome|Recurrence or Not After 2 Months Follow-up|
650769|NCT02223715|O1|Outcome|Clinical Complication|
650770|NCT02223715|O1|Outcome|Status at the End of CDI Episode|To characterize the management and outcome of Clostridium Difficile Infection
650771|NCT02223715|O1|Outcome|Medical History|To characterize the management and outcome of Clostridium Difficile Infection
650772|NCT02223715|E1|Reported Event|Clostridium Difficile Infection|Patient with Clostridium Difficile Infection
650773|NCT02223650|B3|Baseline|Total|Total of all reporting groups
650774|NCT02223650|B2|Baseline|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650775|NCT02223650|B1|Baseline|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650776|NCT02223650|P2|Participant Flow|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650777|NCT02223650|P1|Participant Flow|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650778|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650783|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650784|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
650785|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
650786|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650787|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650788|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650789|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650790|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650791|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650792|NCT02223650|O2|Outcome|Non-overminus Treatment|Spectacle-related questions at follow up apply only to non-overminus group participants prescribed correction spectacles.
650793|NCT02223650|O1|Outcome|Overminus Treatment|Spectacle-related questions at follow up apply to all overminus group participants.
650794|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650795|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650796|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650797|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650798|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650799|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650800|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650801|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650802|NCT02223650|O2|Outcome|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650803|NCT02223650|O1|Outcome|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650804|NCT02223650|E2|Reported Event|Non-overminus Treatment|"spectacles without overminus or no spectacles~Non-overminus treatment: spectacles without overminus or no spectacles"
650805|NCT02223650|E1|Reported Event|Overminus Treatment|"2.50D overminus spectacles~Overminus treatment: 2.50D overminus spectacles"
650806|NCT02223429|B5|Baseline|Total|Total of all reporting groups
650807|NCT02223429|B4|Baseline|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
650808|NCT02223429|B3|Baseline|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650809|NCT02223429|B2|Baseline|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650810|NCT02223429|B1|Baseline|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650811|NCT02223429|P4|Participant Flow|Placebo First, Followed by AVP|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
650812|NCT02223429|P3|Participant Flow|AVP First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650813|NCT02223429|P2|Participant Flow|Placebo First, Followed by OT|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650814|NCT02223429|P1|Participant Flow|OT First, Followed by Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650815|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered vasopressin spray in each nostril. Time between interventions was 2-10 days.
650816|NCT02223429|O1|Outcome|Vasopressin (AVP)|Participants were randomized to receive no more than 1 ml solution of self-administered vasopressin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650817|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650871|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
650818|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650819|NCT02223429|O2|Outcome|Placebo|All participants who were administered placebo at any time point during the study and have completed the cry rating scale.
650820|NCT02223429|O1|Outcome|Vasopressin (AVP)|All participants who were administered AVP at any time point during the study and have completed the cry rating scale.
650821|NCT02223429|O2|Outcome|Placebo|All participants who were administered placebo at any time point during the study and have completed the cry rating scale.
650822|NCT02223429|O1|Outcome|Oxytocin|All participants who were administered oxytocin at any time point during the study and have completed the cry rating scale.
650823|NCT02223429|O1|Outcome|OT + Placebo Group|The OT + placebo group self-administered no more than 1 ml solution of oxytocin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received OT first, and half received OT second.
650824|NCT02223429|O1|Outcome|AVP + Placebo|The AVP + placebo group self-administered no more than 1 ml solution of vasopressin or placebo in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays. The order of administration of drug and placebo was counterbalanced across subjects, such that half received AVP first, and half received AVP second.
650881|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650825|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650826|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650827|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650828|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650829|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650830|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650831|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650832|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650833|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650834|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650835|NCT02223429|O2|Outcome|Placebo|Participants were randomized to receive no more than 1 ml solution of self-administered placebo spray in each nostril followed by no more than 1 ml solution of self-administered oxytocin spray in each nostril. Time between interventions was 2-10 days.
650836|NCT02223429|O1|Outcome|Oxytocin|Participants were randomized to receive no more than 1 ml solution of self-administered oxytocin spray in each nostril followed by no more than 1 ml solution of self-administered placebo spray in each nostril. Time between interventions was 2-10 days.
650837|NCT02223429|E4|Reported Event|Placebo of AVP|"The placebo of AVP group self-administered no more than 1 ml solution of placebo of AVP in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the AVP treatment."
650838|NCT02223429|E3|Reported Event|Placebo of OT|"The placebo of OT group self-administered no more than 1 ml solution of placebo of OT in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the OT treatment."
650839|NCT02223429|E2|Reported Event|AVP Treatment|"The AVP group self-administered no more than 1 ml solution of vasopressin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the Placebo of AVP treatment."
650840|NCT02223429|E1|Reported Event|OT Treatment|"The OT group self-administered no more than 1 ml solution of oxytocin in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays.~This group also went through the Placebo of OT treatment."
650841|NCT02223260|B1|Baseline|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650842|NCT02223260|P1|Participant Flow|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650843|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650844|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650845|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650846|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650847|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650882|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
654478|NCT02189252|O1|Outcome|Epanova 2 g|Once daily (QD)
650848|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650849|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650850|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650851|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650852|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650853|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650854|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650855|NCT02223260|O1|Outcome|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650856|NCT02223260|E1|Reported Event|Dabigatran Etexilate|The patients were orally administered a single dose of liquid formulation of dabigatran etexilate. The dose were adjusted based on an age and weight (equivalent to a 150 mg dose in adults). In case the patient could not take the full dose at once, the assigned dose could have been given as divided doses.
650857|NCT02223065|B3|Baseline|Total|Total of all reporting groups
650858|NCT02223065|B2|Baseline|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
650859|NCT02223065|B1|Baseline|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
650860|NCT02223065|P2|Participant Flow|Treatment BA|"Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.~Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions."
650861|NCT02223065|P1|Participant Flow|Treatment AB|"Treatment A: Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.~Treatment B: Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions."
650862|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
650863|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
650864|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
650865|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
650866|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
650867|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
650868|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
650869|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
650870|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
650872|NCT02223065|O2|Outcome|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
650873|NCT02223065|O1|Outcome|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
650874|NCT02223065|E2|Reported Event|Treatment B|Single oral dose of 5-mg saxagliptin/10-mg dapagliflozin FDC tablet under fasted conditions.
650875|NCT02223065|E1|Reported Event|Treatment A|Single oral dose of 5-mg saxagliptin tablet coadministered with 10-mg dapagliflozin tablet under fasted conditions.
650876|NCT02222870|B3|Baseline|Total|Total of all reporting groups
650877|NCT02222870|B2|Baseline|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650878|NCT02222870|B1|Baseline|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650879|NCT02222870|P2|Participant Flow|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650880|NCT02222870|P1|Participant Flow|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
654479|NCT02189252|E6|Reported Event|Lovaza 4 g (II)|Treatment period II
650883|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650884|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650885|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650886|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650887|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650888|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650889|NCT02222870|O2|Outcome|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650890|NCT02222870|O1|Outcome|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650891|NCT02222870|E2|Reported Event|3 to < 9 Years of Age|Participants 3 to < 9 years of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650892|NCT02222870|E1|Reported Event|6 to < 36 Months of Age|Participants 6 to < 36 months of age who received 1 or 2 intramuscular dose(s) of Fluzone Quadrivalent vaccine.
650893|NCT02222818|B3|Baseline|Total|Total of all reporting groups
650894|NCT02222818|B2|Baseline|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
650895|NCT02222818|B1|Baseline|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
650896|NCT02222818|P2|Participant Flow|Group B: CAFRPlus First|"Subjects randomized to Group B will receive CAFRPlus first, then cross over to CAFR.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
650897|NCT02222818|P1|Participant Flow|Group A: CAFR First|"Subjects randomized to Group A will receive CAFR first, then cross over to CAFRPlus.~Conducted AF Response (CAFR): The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.~Conducted AF Response Plus (CAFRPlus): The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing."
650898|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
650899|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
650900|NCT02222818|O2|Outcome|CAFRPlus ON|Percentage of effective CRT pacing during AF when CAFRPlus is ON
650901|NCT02222818|O1|Outcome|CAFR ON|Percentage of effective CRT pacing during AF when CAFR is ON
650902|NCT02222818|E1|Reported Event|All Enrolled Subjects|All subjects enrolled in the CRTee study.
650959|NCT02221648|B1|Baseline|Placebo|Subjects will be randomization to receive injections with either the study drug (incobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
653387|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
650903|NCT02222558|B1|Baseline|All Study Participants|"Study participants start in Period 1 and proceed to Period 2 and then Period 3 Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.~Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650904|NCT02222558|P6|Participant Flow|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650922|NCT02222207|B1|Baseline|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
650923|NCT02222207|P1|Participant Flow|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
650905|NCT02222558|P5|Participant Flow|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650906|NCT02222558|P4|Participant Flow|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650907|NCT02222558|P3|Participant Flow|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650908|NCT02222558|P2|Participant Flow|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
650909|NCT02222558|P1|Participant Flow|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
650910|NCT02222558|O6|Outcome|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650911|NCT02222558|O5|Outcome|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650912|NCT02222558|O4|Outcome|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650913|NCT02222558|O3|Outcome|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650914|NCT02222558|O2|Outcome|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
650915|NCT02222558|O1|Outcome|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
650916|NCT02222558|E6|Reported Event|Period 3: Three Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650917|NCT02222558|E5|Reported Event|Period 3: Two Times Daily Dosing 180 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650918|NCT02222558|E4|Reported Event|Period 3: Three Times Daily Dosing 90 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted three times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
651011|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
653902|NCT02195713|B3|Baseline|Total|Total of all reporting groups
650919|NCT02222558|E3|Reported Event|Period 3: Two Times Daily Dosing 120 mg|"Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days. On Day 15, a serum Testosterone level will be drawn and used to dose titrate and randomized to BID or TID (as eligible). The TSX-002 dose will be down or up titrated.~Period 3: Begins Day 18 with the first adjusted TSX-002 dose administered fasted two times daily. The Testosterone level on Day 22 will be used to perform the final, TSX-002 dose adjustment."
650920|NCT02222558|E2|Reported Event|Period 2: Two Times Daily Dosing 90 mg|Period 2: Each study subject dose is 90 mg twice daily of TSX-002, fasted for 17 days.
650921|NCT02222558|E1|Reported Event|Period 1: Single Dose|Period 1: Each study subject will receive an escalating single dose of TSX-002 (60, 90, 120, 180, 240 mg), with a minimum 3 day wash-out between each of the 5 escalating doses. After completing the 240 mg dose, a 7 day wash-out period will occur prior to Period 2.
651192|NCT02219256|P12|Participant Flow|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
650924|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
650925|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
650926|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
650927|NCT02222207|O1|Outcome|Part A Regorafenib|Participants self-administered 30 milligram per milliliter (mg/mL), 25 microliter (mcL),1 drop of Regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
650928|NCT02222207|E1|Reported Event|Part A Regorafenib|Participants self-administered 30 mg/mL, 25 mcL, 1 drop of regorafenib eye drops, topically thrice daily (TID) to the study eye for 12 weeks.
650929|NCT02222181|B1|Baseline|Treatment|patients in treatment for Alzheimer's disease.
650930|NCT02222181|P1|Participant Flow|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650931|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650932|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650933|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650934|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650935|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650936|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650937|NCT02222181|O1|Outcome|Pharmacotherapy Follow-up|All the patients received pharmacotherapy workup at baseline and after the intervention.
650938|NCT02222181|E1|Reported Event|Treatment|Do not apply.
650939|NCT02222129|B3|Baseline|Total|Total of all reporting groups
650940|NCT02222129|B2|Baseline|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
650941|NCT02222129|B1|Baseline|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
650942|NCT02222129|P2|Participant Flow|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
650943|NCT02222129|P1|Participant Flow|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
650944|NCT02222129|O2|Outcome|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
650945|NCT02222129|O1|Outcome|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
650946|NCT02222129|E2|Reported Event|Liposomal Bupivacaine|"Surgical site infiltration of liposomal bupivacaine.~liposomal bupivacaine"
650947|NCT02222129|E1|Reported Event|Bupivacaine|"Surgical site infiltration of 0.25% bupivacaine.~Bupivacaine"
650948|NCT02221947|B3|Baseline|Total|Total of all reporting groups
650949|NCT02221947|B2|Baseline|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
650950|NCT02221947|B1|Baseline|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
650951|NCT02221947|P2|Participant Flow|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
650952|NCT02221947|P1|Participant Flow|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
650953|NCT02221947|O2|Outcome|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
650954|NCT02221947|O1|Outcome|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
650955|NCT02221947|E2|Reported Event|Placebo|"single dose of placebo, intravenous infusion over 1 hour~Placebo: Placebo, single dose via intravenous infusion over 1 hour."
650956|NCT02221947|E1|Reported Event|Bryostatin 1|"single dose of 25 μg/m2 bryostatin, intravenous infusion over 1 hour~Bryostatin 1: 25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour."
650957|NCT02221648|B3|Baseline|Total|Total of all reporting groups
650958|NCT02221648|B2|Baseline|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug abobotulinumtoxinA.
651012|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
653388|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
650960|NCT02221648|P2|Participant Flow|ArbobotulinumtoxinA Treatment|"Subjects will receive intervention injections with the study drug abobotulinumtoxinA.~AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA. A series of rating scale and an examination will take place prior to treatment and at 4 and 8 weeks post treatment."
650961|NCT02221648|P1|Participant Flow|Placebo|Subjects will be randomized to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive for the first injections.
650962|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|"Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA.~AbobotulinumtoxinA Treatment: Subjects receive intervention injections with the study drug arbobotulinumtoxinA."
650963|NCT02221648|O1|Outcome|Placebo|"Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive.~Placebo: Subjects will be randomization to receive either the study drug or the placebo group."
650964|NCT02221648|O2|Outcome|botulinumtoxinA Treatment|Subjects received botox injection.
650965|NCT02221648|O1|Outcome|Placebo|Study group received placebo injection.
650966|NCT02221648|O2|Outcome|AbobotulinumtoxinA Treatment|All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
650967|NCT02221648|O1|Outcome|Placebo|Subjects will be randomized to receive injections with saline.
650968|NCT02221648|E2|Reported Event|ArbobotulinumtoxinA Treatment|AbobotulinumtoxinA Treatment: All subjects will receive intervention injections with the study drug arbobotulinumtoxinA.
650969|NCT02221648|E1|Reported Event|Placebo|Subjects will be randomized to receive injections with placebo.
650970|NCT02220998|B3|Baseline|Total|Total of all reporting groups
650971|NCT02220998|B2|Baseline|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650972|NCT02220998|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650973|NCT02220998|P2|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650974|NCT02220998|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
650975|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650976|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650977|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650978|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650979|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650980|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650981|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650982|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650983|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650984|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650985|NCT02220998|O2|Outcome|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650986|NCT02220998|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650987|NCT02220998|E2|Reported Event|SOF+RBV|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
650988|NCT02220998|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
650989|NCT02220920|B3|Baseline|Total|Total of all reporting groups
650990|NCT02220920|B2|Baseline|Placebo＋Insulin|Placebo, once daily for 16 weeks
650991|NCT02220920|B1|Baseline|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
650992|NCT02220920|P2|Participant Flow|Placebo＋Insulin|Placebo, once daily for 16 weeks
650993|NCT02220920|P1|Participant Flow|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
650994|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
650995|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
650996|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
650997|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
650998|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
650999|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
651000|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
651001|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
651002|NCT02220920|O2|Outcome|Placebo＋Insulin|Placebo, once daily for 16 weeks
651003|NCT02220920|O1|Outcome|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
651004|NCT02220920|E2|Reported Event|Placebo＋Insulin|Placebo, once daily for 16 weeks
651005|NCT02220920|E1|Reported Event|Canagliflozin (TA-7284) ＋Insulin|Canagliflozin, once daily for 16 weeks
651006|NCT02220764|B3|Baseline|Total|Total of all reporting groups
651007|NCT02220764|B2|Baseline|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
651008|NCT02220764|B1|Baseline|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
651009|NCT02220764|P2|Participant Flow|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
651010|NCT02220764|P1|Participant Flow|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
651013|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
651014|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
651015|NCT02220764|O2|Outcome|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
651016|NCT02220764|O1|Outcome|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
651017|NCT02220764|E2|Reported Event|Implant-supported|"Long-span implant-supported zirconia based fixed dental prostheses~Implant abutments"
651018|NCT02220764|E1|Reported Event|Tooth-supported|"Long-span tooth-supported zirconia based fixed dental prostheses~Teeth abutment"
651019|NCT02220205|B3|Baseline|Total|Total of all reporting groups
651020|NCT02220205|B2|Baseline|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
651021|NCT02220205|B1|Baseline|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
654480|NCT02189252|E5|Reported Event|Epanova 4 g (II)|Treatment period II
651022|NCT02220205|P2|Participant Flow|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
651023|NCT02220205|P1|Participant Flow|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
651024|NCT02220205|O2|Outcome|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
651025|NCT02220205|O1|Outcome|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
651026|NCT02220205|O2|Outcome|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
651027|NCT02220205|O1|Outcome|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
651028|NCT02220205|E2|Reported Event|Manufacturer Model|"Participants randomized to this arm practice IUD insertion on models provided by the IUD manufacturer for 30 minutes.~Manufacturer model"
651029|NCT02220205|E1|Reported Event|PelvicSim|"Participants randomized to this arm practice IUD insertion on the PelvicSim for 30 minutes.~PelvicSim"
651030|NCT02219997|B3|Baseline|Total|Total of all reporting groups
651031|NCT02219997|B2|Baseline|Clear IOL|Clear IOL with blue light filter clip-on glasses and clear clip-on glasses, worn in a cross-over fashion, as randomized, for 4 hours total
651032|NCT02219997|B1|Baseline|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
651033|NCT02219997|P3|Participant Flow|Clear IOL: Placebo Filter First, Then BLF|Clear IOL with clear clip-on glasses worn first and blue light filter clip-on glasses worn second for 4 hours total
651034|NCT02219997|P2|Participant Flow|Clear IOL: BLF First, Then Placebo Filter|Clear IOL with blue light filter clip-on glasses worn first and clear clip-on glasses worn second for 4 hours total
651035|NCT02219997|P1|Participant Flow|AcrySof IQ IOL|ACRYSOF® IQ IOL with clear clip-on glasses worn for 3 hours
651036|NCT02219997|O2|Outcome|Clear IOL + BLF|Clear IOL with clip-on glasses with blue light filtering properties
651037|NCT02219997|O1|Outcome|ACRYSOF IQ IOL + Placebo Filter|ACRYSOF® IQ IOL with clear clip-on glasses with no light filtering properties used as a placebo
651038|NCT02219997|O2|Outcome|Blue Light Filter|Clear IOL with clip-on glasses with blue light filtering properties
651039|NCT02219997|O1|Outcome|Placebo Filter|Clear IOLs with placebo colored clip-on filters
651040|NCT02219997|O2|Outcome|Clear IOL|Clear IOL without filters
651041|NCT02219997|O1|Outcome|AcrySof IQ IOL|ACRYSOF® IQ IOL without filters
651042|NCT02219997|E3|Reported Event|Clear IOL|All subjects implanted with Clear IOLs from time of initiation of experimental testing
651043|NCT02219997|E2|Reported Event|AcrySof IQ IOL|All subjects implanted with ACRYSOF® IQ IOLs from time of initiation of experimental testing
651044|NCT02219997|E1|Reported Event|Pre-treatment|All subjects from time to consent until initiation of experimental testing
651045|NCT02219932|B3|Baseline|Total|Total of all reporting groups
651046|NCT02219932|B2|Baseline|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651047|NCT02219932|B1|Baseline|Placebo|Placebo BID for up to 24 weeks
651048|NCT02219932|P2|Participant Flow|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651049|NCT02219932|P1|Participant Flow|Placebo|Placebo twice daily (BID) for up to 24 weeks
651050|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651051|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
651052|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651053|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
651054|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651055|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
651056|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651057|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
651058|NCT02219932|O2|Outcome|Fampridine 10 mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651059|NCT02219932|O1|Outcome|Placebo|Placebo BID for up to 24 weeks
651060|NCT02219932|E2|Reported Event|Fampridine 10mg BID|Prolonged-release fampridine 10 mg BID for up to 24 weeks
651061|NCT02219932|E1|Reported Event|Placebo|Placebo twice daily (BID) for up to 24 weeks
651062|NCT02219685|B3|Baseline|Total|Total of all reporting groups
651063|NCT02219685|B2|Baseline|Placebo|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
651064|NCT02219685|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
651065|NCT02219685|P2|Participant Flow|Placebo, Followed by Open-Label LDV/SOF|LDV/SOF placebo tablet once daily for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
654983|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
651066|NCT02219685|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks
651067|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651068|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651069|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651070|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651071|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651072|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651073|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
654481|NCT02189252|E4|Reported Event|Epanova 2 g (II)|Treatment period II
651074|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651075|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651076|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651077|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651078|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651079|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651080|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651081|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651082|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651083|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651084|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651085|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651086|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651087|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651088|NCT02219685|O2|Outcome|Open-Label Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
651089|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651090|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651091|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651092|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651093|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651094|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651095|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651096|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651097|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651098|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651099|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651100|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651101|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651102|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651103|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651104|NCT02219685|O2|Outcome|Blinded Phase: Placebo|LDV/SOF placebo tablet once daily for 12 weeks during the Blinded Treatment Phase
651105|NCT02219685|O1|Outcome|Blinded Phase: LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Blinded Treatment Phase
651106|NCT02219685|E3|Reported Event|LDV/SOF (Open-Label Phase), Following Placebo in Blinded Phase|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks during the Open-Label Treatment Phase
651107|NCT02219685|E2|Reported Event|Placebo (Blinded Phase)|LDV/SOF placebo tablet once daily for 12 weeks
651108|NCT02219685|E1|Reported Event|LDV/SOF (Blinded Phase)|LDV/SOF (90/400 mg) FDC tablet once daily for 12 weeks
651109|NCT02219516|B5|Baseline|Total|Total of all reporting groups
651110|NCT02219516|B4|Baseline|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651111|NCT02219516|B3|Baseline|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651112|NCT02219516|B2|Baseline|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651113|NCT02219516|B1|Baseline|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651114|NCT02219516|P4|Participant Flow|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651115|NCT02219516|P3|Participant Flow|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651116|NCT02219516|P2|Participant Flow|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651117|NCT02219516|P1|Participant Flow|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651118|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651119|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
654482|NCT02189252|E3|Reported Event|Lovaza 4 g (I)|Treatment period I
651120|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651121|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651122|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651123|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651124|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651125|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651126|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651127|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651128|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651129|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651130|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651131|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651132|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651133|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651134|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651135|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651136|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651137|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651138|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651139|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651140|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651141|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651142|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651143|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651144|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651145|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651146|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651147|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651148|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651149|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651150|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651151|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651152|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651153|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651154|NCT02219516|O4|Outcome|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651155|NCT02219516|O3|Outcome|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651156|NCT02219516|O2|Outcome|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
651157|NCT02219516|O1|Outcome|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651158|NCT02219516|E4|Reported Event|Cohort 4: Normal Renal Function + RDEA3170 15 mg|Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted
651159|NCT02219516|E3|Reported Event|Cohort 3: Severe Renal Impairment + RDEA3170 15 mg|Severe Renal Impairment (eCrCl of 15 to < 30 mL/min) + RDEA3170 15 mg qd fasted
651160|NCT02219516|E2|Reported Event|Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg|Moderate Renal Impairment (eCrCl of 30 to < 60 mL/min) + RDEA3170 15 mg qd fasted
654483|NCT02189252|E2|Reported Event|Epanova 4 g (I)|Treatment period I
651161|NCT02219516|E1|Reported Event|Cohort 1: Mild Renal Impairment + RDEA3170 15 mg|Mild Renal Impairment (eCrCl of 60 to < 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted
651162|NCT02219503|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
651163|NCT02219503|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
651164|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
651165|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
651166|NCT02219503|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
651167|NCT02219503|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) administered for 12 weeks.
651168|NCT02219464|B3|Baseline|Total|Total of all reporting groups
651169|NCT02219464|B2|Baseline|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651170|NCT02219464|B1|Baseline|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651171|NCT02219464|P2|Participant Flow|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651172|NCT02219464|P1|Participant Flow|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651173|NCT02219464|O2|Outcome|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651174|NCT02219464|O1|Outcome|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651175|NCT02219464|O2|Outcome|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651176|NCT02219464|O1|Outcome|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651177|NCT02219464|E2|Reported Event|Nasal Cannula|"Patients will receive oxygen supplementation through the use of a traditional nasal cannula. Sedation will be standardized to ensure consistency between groups.~Nasal Cannula~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651178|NCT02219464|E1|Reported Event|Nasopharyngeal Catheter|"Patients in this arm will receive oxygen supplementation through the use of a Nasopharyngeal catheter. Sedation will be standardized to ensure consistency between groups.~Nasopharyngeal catheter~Oxygen Supplementation: Initially set at 4 liters/minute~Sedation: Propofol infusion at 100mcg/kg/min and any increase in propofol was at the discretion of the attending anesthesiologist."
651179|NCT02219256|B13|Baseline|Total|Total of all reporting groups
651180|NCT02219256|B12|Baseline|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651181|NCT02219256|B11|Baseline|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651182|NCT02219256|B10|Baseline|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651183|NCT02219256|B9|Baseline|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651184|NCT02219256|B8|Baseline|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651185|NCT02219256|B7|Baseline|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651186|NCT02219256|B6|Baseline|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651187|NCT02219256|B5|Baseline|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651188|NCT02219256|B4|Baseline|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651189|NCT02219256|B3|Baseline|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651190|NCT02219256|B2|Baseline|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651191|NCT02219256|B1|Baseline|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
654484|NCT02189252|E1|Reported Event|Epanova 2 g (I)|Treatment period I
651193|NCT02219256|P11|Participant Flow|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651194|NCT02219256|P10|Participant Flow|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651195|NCT02219256|P9|Participant Flow|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651196|NCT02219256|P8|Participant Flow|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651197|NCT02219256|P7|Participant Flow|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651198|NCT02219256|P6|Participant Flow|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651199|NCT02219256|P5|Participant Flow|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651200|NCT02219256|P4|Participant Flow|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651201|NCT02219256|P3|Participant Flow|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651202|NCT02219256|P2|Participant Flow|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651203|NCT02219256|P1|Participant Flow|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651204|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651205|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651206|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651207|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651208|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651209|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651210|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651211|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651212|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651213|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651214|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651215|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651216|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651217|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651218|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651219|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651220|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651221|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651222|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651223|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651224|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651225|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651226|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651227|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651228|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651229|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651230|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651231|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651232|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651233|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651234|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651235|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651236|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651237|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651238|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651239|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651240|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651241|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651242|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651243|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651244|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651245|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651246|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651247|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651248|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651249|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651250|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651251|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651252|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651253|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651254|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651255|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651256|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651257|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651258|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651259|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651260|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651261|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651262|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651263|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651264|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651265|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651266|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651267|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651268|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651269|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651270|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651271|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651272|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651273|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651274|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651275|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651276|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651277|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651278|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651279|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651280|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651281|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651282|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651283|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651284|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651285|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651286|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651287|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651288|NCT02219256|O12|Outcome|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651289|NCT02219256|O11|Outcome|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651290|NCT02219256|O10|Outcome|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651291|NCT02219256|O9|Outcome|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651292|NCT02219256|O8|Outcome|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651293|NCT02219256|O7|Outcome|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
651294|NCT02219256|O6|Outcome|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651295|NCT02219256|O5|Outcome|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651296|NCT02219256|O4|Outcome|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651297|NCT02219256|O3|Outcome|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
656434|NCT02169466|B5|Baseline|Total|Total of all reporting groups
651298|NCT02219256|O2|Outcome|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651299|NCT02219256|O1|Outcome|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651300|NCT02219256|E12|Reported Event|TAK-079 0.6 mg/kg SC|TAK-079 0.6 mg/kg, infusion solution, SC, once on Day 1.
651301|NCT02219256|E11|Reported Event|TAK-079 0.3 mg/kg SC|TAK-079 0.3 mg/kg, infusion solution, SC, once on Day 1.
651302|NCT02219256|E10|Reported Event|TAK-079 0.1 mg/kg SC|TAK-079 0.01 mg/kg, infusion solution, SC, once on Day 1
651303|NCT02219256|E9|Reported Event|TAK-079 0.03 mg/kg SC|TAK-079 0.03 mg/kg, infusion solution, SC, once on Day 1.
651304|NCT02219256|E8|Reported Event|TAK-079 Pooled Placebo SC|TAK-079 placebo-matching, infusion solution, SC, once on Day 1.
651305|NCT02219256|E7|Reported Event|TAK-079 0.06 mg/kg IV|TAK-079 0.06 mg/kg, infusion solution, IV, once on Day 1.
654815|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
651306|NCT02219256|E6|Reported Event|TAK-079 0.03 mg/kg IV|TAK-079 0.03 mg/kg, infusion solution, IV, once on Day 1.
651307|NCT02219256|E5|Reported Event|TAK-079 0.01 mg/kg IV|TAK-079 0.01 mg/kg, infusion solution, IV, once on Day 1.
651308|NCT02219256|E4|Reported Event|TAK-079 0.003 mg/kg IV|TAK-079 0.003 mg/kg, infusion solution, IV, once on Day 1.
651309|NCT02219256|E3|Reported Event|TAK-079 0.001 mg/kg IV|TAK-079 0.001 mg/kg, infusion solution, IV, once on Day 1.
651310|NCT02219256|E2|Reported Event|TAK-079 0.0003 mg/kg IV|TAK-079 0.0003 mg/kg, infusion solution, IV, once on Day 1.
651311|NCT02219256|E1|Reported Event|TAK-079 Pooled Placebo IV|TAK-079 placebo-matching, infusion solution, IV, once on Day 1.
651312|NCT02218697|B3|Baseline|Total|Total of all reporting groups
651313|NCT02218697|B2|Baseline|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651314|NCT02218697|B1|Baseline|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651315|NCT02218697|P2|Participant Flow|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651316|NCT02218697|P1|Participant Flow|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651317|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651318|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651319|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651320|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651321|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651322|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651323|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651324|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651325|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651326|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651327|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651328|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651329|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651330|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651331|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651332|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651333|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651334|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651335|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651336|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651337|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651338|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651339|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651340|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651341|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651342|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651343|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651344|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651345|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651512|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651346|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651347|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651348|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651349|NCT02218697|O2|Outcome|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651350|NCT02218697|O1|Outcome|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651351|NCT02218697|E2|Reported Event|Co-Ad Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of Pneumovax™ 23 vaccine at Day 0 and 1 dose of placebo at Day 28.
651352|NCT02218697|E1|Reported Event|Control Group|Subjects received 1 dose of Influsplit™ Tetra vaccine and 1 dose of placebo at Day 0 and 1 dose of Pneumovax™ 23 vaccine at Day 28.
651353|NCT02218307|B3|Baseline|Total|Total of all reporting groups
651354|NCT02218307|B2|Baseline|Placebo|"Placebo control for mupirocin~Placebo"
651355|NCT02218307|B1|Baseline|Mupirocin|"topical antibiotic~Mupirocin"
651356|NCT02218307|P2|Participant Flow|Placebo|"Placebo control for mupirocin~Placebo"
651357|NCT02218307|P1|Participant Flow|Mupirocin|"topical antibiotic~Mupirocin"
651358|NCT02218307|O2|Outcome|Placebo|"Placebo control for mupirocin~Placebo"
651359|NCT02218307|O1|Outcome|Mupirocin|"topical antibiotic~Mupirocin"
651360|NCT02218307|O2|Outcome|Placebo|"Placebo control for mupirocin~Placebo"
651361|NCT02218307|O1|Outcome|Mupirocin|"topical antibiotic~Mupirocin"
651362|NCT02218307|E2|Reported Event|Placebo|"Placebo control for mupirocin~Placebo"
651363|NCT02218307|E1|Reported Event|Mupirocin|"topical antibiotic~Mupirocin"
651364|NCT02218268|B1|Baseline|All Participants|This is a crossover study of youth with Diabetes on a stable basal bolus insulin regimen. They will be randomized either receive a pre-meal insulin bolus in conjunction with their Basal insulin bolus or receive their standard of care basal insulin bolus only. A mixed meal replacement (Boost) will be consumed. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
651365|NCT02218268|P2|Participant Flow|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
651366|NCT02218268|P1|Participant Flow|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
651367|NCT02218268|O2|Outcome|No Meal Bolus Then Pre-meal Bolus|"A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
651368|NCT02218268|O1|Outcome|Pre-meal Bolus Then No Meal Bolus|"A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring.~Then 3 months later A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring."
651369|NCT02218268|E2|Reported Event|No Meal Bolus Then Pre-meal Bolus|A meal replacement drink (Boost) will be given but the subject will not receive a meal bolus. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring, This is a crossover study and all participants will take place in this arm after 3 months of their visit.
651396|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651397|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651370|NCT02218268|E1|Reported Event|Pre-meal Bolus Then No Meal Bolus|A meal replacement drink (Boost) and bolus of rapid insulin will be given to this group. Glucose will be monitored with a finger prick before they drink the meal replacement, 1 hour later and finally 2 hours after drinking the meal replacement. Stiffness of the blood vessel of the wrist will be determined using radial tonometry and will be done at the same time as the glucose monitoring. This is a crossover study and all participants will take place in this arm after 3 months of their visit.
651371|NCT02217982|B3|Baseline|Total|Total of all reporting groups
651372|NCT02217982|B2|Baseline|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
651373|NCT02217982|B1|Baseline|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
651374|NCT02217982|P2|Participant Flow|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
651375|NCT02217982|P1|Participant Flow|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
651376|NCT02217982|O2|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
651377|NCT02217982|O1|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
651378|NCT02217982|O2|Outcome|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
651379|NCT02217982|O1|Outcome|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
651380|NCT02217982|E2|Reported Event|Treatment Arm|"Patients who are randomized to the treatment arm will be instructed to take 125 mg simethicone and one tablespoon of a high fat food (peanut butter)10 minutes prior to each DMF dose. If the average MAGIS score is greater than 3.5 in the diarrhea category they will also be instructed to take 2 mg loperamide three times daily.~Simethicone~Loperamide~Peanut Butter"
651381|NCT02217982|E1|Reported Event|Control Group|Patients randomized to the standard therapy arm will be instructed to follow the normal dosing regimen for DMF with a food bolus of their choice prior to dosing. If severe symptoms (MAGIS >6.5) are noted at any time post randomization in any MAGIS category, crossover to the treatment arm will be allowed. Both groups will be asked to rate their GI symptoms over the past 24 hours using the MAGIS scale once daily.
651382|NCT02217878|B3|Baseline|Total|Total of all reporting groups
651383|NCT02217878|B2|Baseline|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651384|NCT02217878|B1|Baseline|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651385|NCT02217878|P2|Participant Flow|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651386|NCT02217878|P1|Participant Flow|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651387|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651388|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651389|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651390|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651391|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651392|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651393|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651394|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651395|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651398|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651399|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651400|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651401|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651402|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651403|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651404|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651405|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651406|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651407|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651408|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651409|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651410|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651411|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651412|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651413|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651414|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651415|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651416|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651417|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651418|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651419|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651420|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651421|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651422|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651423|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651424|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651425|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651426|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651427|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651428|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651429|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651430|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651431|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651432|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651433|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651434|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651435|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651436|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651437|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651438|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651439|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651440|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651441|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651442|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651443|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651444|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651445|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651446|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651447|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651448|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651449|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651450|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651451|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651452|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651453|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651454|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651455|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651456|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651457|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651458|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651459|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651460|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651461|NCT02217878|O2|Outcome|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651462|NCT02217878|O1|Outcome|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651463|NCT02217878|E2|Reported Event|Placebo|"sodium chloride 0,9% 5 mg IV followed by 180 mg loading dose of ticagrelor~Placebo: IV bolus injection~Ticagrelor: 180 mg loading dose"
651464|NCT02217878|E1|Reported Event|Morphine|"morphine sulfate 5 mg IV followed by 180 mg loading dose of ticagrelor~Morphine: IV bolus injection~Ticagrelor: 180 mg loading dose"
651465|NCT02216695|B1|Baseline|Acute Kidney Injury|we analysed acute kidney injury requiring dialysis in England
651466|NCT02216695|P1|Participant Flow|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
651467|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|The associations between discharge status was tested with multivariable regression model which included age group and discharge period,
651468|NCT02216695|O1|Outcome|Acute Kidney Injury Requiring Dialysis|Age was categorized into the groups 65, 65–74, 75–84, and > 85. The associations between discharge status was tested with multivariable regression model which included gender, age group, discharge period, admission method, CCS, ethnicity, and AKI in diagnoses code.
651469|NCT02216695|O1|Outcome|Acute Kidney Injury|All patients who had acute kidney injury requiring dialysis between 1998 and 2013 were identified from hospital episode statistic
651470|NCT02216695|O3|Outcome|2008-13|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
651471|NCT02216695|O2|Outcome|2003-08|Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
651472|NCT02216695|O1|Outcome|1998-03|All patients who had acute kidney injury and required dialysis between 1998 and 2013 were identified from hospital episode statistic.Data during the 15-year period were divided into three 5-year periods (April 1988 to March 2003, April 2003 to March 2008 and April 2008 to March 2013)
651473|NCT02216695|E1|Reported Event|Dialysis Requiring AKI|AKI patients who required renal replacement therapy
651474|NCT02216422|B1|Baseline|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
651511|NCT02216097|P1|Participant Flow|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651475|NCT02216422|P1|Participant Flow|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
651476|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
651477|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
651478|NCT02216422|O1|Outcome|Ombitasvir/Paritaprevir/Ritonavir Plus Dasabuvir With RBV|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
651479|NCT02216422|E1|Reported Event|Ombitasvir/Paritaprevir/Ritonavir Plus|Ombitasvir/Paritaprevir/Ritonavir (25/150/100 mg once daily) and Dasabuvir (250 mg twice daily) co-administered with weight-based Ribavirin (RBV; twice daily) for 12 weeks.
651480|NCT02216357|B3|Baseline|Total|Total of all reporting groups
651481|NCT02216357|B2|Baseline|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651482|NCT02216357|B1|Baseline|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651483|NCT02216357|P2|Participant Flow|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651484|NCT02216357|P1|Participant Flow|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651485|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651486|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651487|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651488|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651489|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651490|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651491|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651492|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651493|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651494|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651495|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651496|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651497|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651498|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651499|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651500|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651501|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651502|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651503|NCT02216357|O2|Outcome|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651504|NCT02216357|O1|Outcome|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651505|NCT02216357|E2|Reported Event|Placebo, Oral Capsule|"Placebo, Oral Capsule; matching capsules for oral ifetroban dosing, four capsules once per day on Study Days 1, 2, and 3.~Placebo, Oral Capsule"
651557|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651506|NCT02216357|E1|Reported Event|Ifetroban, Oral Capsule|"Ifetroban, Oral Capsule; 200 mg per dose (four - 50 mg capsules), once per day on Study Days 1, 2, and 3.~Ifetroban, Oral Capsule"
651507|NCT02216097|B3|Baseline|Total|Total of all reporting groups
651508|NCT02216097|B2|Baseline|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651509|NCT02216097|B1|Baseline|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651510|NCT02216097|P2|Participant Flow|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651513|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651514|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651515|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651516|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651517|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651518|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651519|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651520|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651521|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651522|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651523|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651524|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651525|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651526|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651527|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651528|NCT02216097|O2|Outcome|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651529|NCT02216097|O1|Outcome|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651530|NCT02216097|E2|Reported Event|Placebo|Placebo matched to PF-04457845 was orally administered once daily in the morning on Days 1 to 7.
651531|NCT02216097|E1|Reported Event|PF-04457845|PF-04457845 4 milligrams (mg) was orally administered once daily in the morning on Days 1 to 7.
651532|NCT02215252|B4|Baseline|Total|Total of all reporting groups
651533|NCT02215252|B3|Baseline|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651534|NCT02215252|B2|Baseline|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651535|NCT02215252|B1|Baseline|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651536|NCT02215252|P3|Participant Flow|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651537|NCT02215252|P2|Participant Flow|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651538|NCT02215252|P1|Participant Flow|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651539|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651540|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651541|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651542|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651543|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651544|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651545|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651546|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651547|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651548|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651549|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651550|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651551|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651552|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651553|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651554|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651555|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651556|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651559|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651560|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651561|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651562|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651563|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651564|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651565|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651566|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651567|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651568|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651569|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651570|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651571|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651572|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651573|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651574|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651575|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651576|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651577|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651578|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651579|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651580|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651581|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651582|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651583|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651584|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651585|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651586|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651587|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651588|NCT02215252|O3|Outcome|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651589|NCT02215252|O2|Outcome|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651590|NCT02215252|O1|Outcome|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651591|NCT02215252|E3|Reported Event|Placebo|Participants received matched placebo oral capsule for 4 weeks.
651592|NCT02215252|E2|Reported Event|Pregabalin|Participants received pregabalin, oral capsule, 150 mg/day, then 300 mg/day from Day 8, for 4 weeks.
651593|NCT02215252|E1|Reported Event|PF-05089771 150 mg BID|Participants received PF-05089771 150mg oral capsules twice daily (BID) for 4 weeks.
651594|NCT02214615|B3|Baseline|Total|Total of all reporting groups
651595|NCT02214615|B2|Baseline|Placebo the Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651596|NCT02214615|B1|Baseline|Carbamazepine Then Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651629|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
651597|NCT02214615|P2|Participant Flow|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651605|NCT02214238|B3|Baseline|Total|Total of all reporting groups
651598|NCT02214615|P1|Participant Flow|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651599|NCT02214615|O2|Outcome|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651600|NCT02214615|O1|Outcome|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651601|NCT02214615|O2|Outcome|Placebo Then Carbamazepine|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651602|NCT02214615|O1|Outcome|Carbamazepine Then Placebo|"Administered in gradual doses from 200 mg twice a day increasing to no more than 800 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651603|NCT02214615|E2|Reported Event|Placebo|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce to match dosing with carbamazepine. After 2 weeks of steady dose drug will be tapered down every 3 days.~Placebo: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651630|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
651631|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
651604|NCT02214615|E1|Reported Event|Carbamazepine|"Administered in gradual doses from 100 mg twice a day increasing to no more than 400 mg twice a day if symptoms do not reduce. After 2 weeks of steady dose drug will be tapered down every 3 days.~Carbamazepine: Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day.~Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
651606|NCT02214238|B2|Baseline|Modified PAP Device First, Then Market Released PAP Device|Us of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
651607|NCT02214238|B1|Baseline|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
651608|NCT02214238|P2|Participant Flow|Modified PAP Device First, Then Market Released PAP Device|Use of the modified PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the market released PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
651609|NCT02214238|P1|Participant Flow|Market Released PAP Device First, Then Modified PAP Device|Use of a market released PAP device first for 3 week (with a 4 day window) followed by an in lab sleep study. Patient then crossed over to use the modified PAP device for 3 weeks (with a 4 day window) followed by another in lab sleep study.
651610|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device~PAP device"
651611|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device~PAP device"
651612|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device~PAP device"
651613|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device~PAP device"
651614|NCT02214238|O2|Outcome|Modified PAP Device|"Use of the modified PAP device~PAP device"
651615|NCT02214238|O1|Outcome|Market Released PAP Device|"Use of a market released PAP device~PAP device"
651616|NCT02214238|E2|Reported Event|Market Released PAP Device|Use of a market released PAP device for 3 more weeks.
651617|NCT02214238|E1|Reported Event|Modified PAP Device|Use of a modified PAP device for 3 more weeks.
651618|NCT02214225|B4|Baseline|Total|Total of all reporting groups
651619|NCT02214225|B3|Baseline|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~TIV-2 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
651620|NCT02214225|B2|Baseline|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~TIV-1 dose: One 0.5 mL intramuscular dose into the deltoid muscle."
651621|NCT02214225|B1|Baseline|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~QIV dose: One 0.5 mL intramuscular dose into the deltoid muscle."
651622|NCT02214225|P3|Participant Flow|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
651623|NCT02214225|P2|Participant Flow|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
651624|NCT02214225|P1|Participant Flow|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
651625|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
651626|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
651627|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
651628|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
651632|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
651633|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
651763|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651634|NCT02214225|O3|Outcome|Trivalent Influenza Vaccine (TIV-2)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
651635|NCT02214225|O2|Outcome|Trivalent Influenza Vaccine (TIV-1)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
651636|NCT02214225|O1|Outcome|Quadrivalent Influenza Vaccine (QIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
651637|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
651638|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
651639|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
651640|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
651641|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
651642|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
651643|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
651644|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
651645|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
651646|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
651647|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
651648|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
651649|NCT02214225|O6|Outcome|bioCSL TIV-1 (B/VIC) (≥ 65 Years)|
651650|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
651651|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
651652|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
651653|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
651654|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
651655|NCT02214225|O6|Outcome|bioCSL TIV-2 (B/VIC) (≥ 65 Years)|
651656|NCT02214225|O5|Outcome|bioCSL TIV-1 (B/YAM) (≥ 65 Years)|
651657|NCT02214225|O4|Outcome|bioCSL QIV (≥ 65 Years)|
651658|NCT02214225|O3|Outcome|bioCSL TIV-2 (B/VIC) (18 to <65 Years)|
651659|NCT02214225|O2|Outcome|bioCSL TIV-1 (B/YAM) (18 to <65 Years)|
651660|NCT02214225|O1|Outcome|bioCSL QIV (18 to <65 Years)|
651661|NCT02214225|O2|Outcome|SCR: Pooled TIV-1 or TIV-2|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854. B/Yamagata serology for TIV-2 (B Victoria), Adults 18 to <65 years, n=421. B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years to <65 years, n=424.~B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429. B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430."
651662|NCT02214225|O1|Outcome|SCR: bioCSL QIV|"For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, Adults 18 years and older, n=1691. bioCSL QIV, Adults 18 years to <65 years, n=835. bioCSL QIV, Adults 65 years and older, n=856."
651663|NCT02214225|O2|Outcome|Postvaccination GMT: TIV-1 (B/YAM) or TIV-2 (B/VIC)|B/Yamagata serology for TIV-2 (B Victoria), Adults 18 years and older, n=850 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 years and older, n=854 B/Yamagata serology for TIV-2 (B Victoria), Adults 18 through 64 years inclusive, n=421 B/Victoria serology for TIV-1 (B Yamagata), Adults 18 through 64 years inclusive, n=424 B/Yamagata serology for TIV-2 (B Victoria), Adults 65 years and older, n=429 B/Victoria serology for TIV-1 (B Yamagata), Adults 65 years and older, n=430.
651664|NCT02214225|O1|Outcome|Postvaccination GMT: bioCSL QIV|bioCSL QIV, Adults 18 years and older, N=1691. 18 to < 65 years, n=835. => 65 years, n=856.
651665|NCT02214225|O4|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
651666|NCT02214225|O3|Outcome|SCR: bioCSL QIV (≥ 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
651667|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=856. Pooled TIV (A strains), n=859. TIV-1 (B Yamagata), n=430. TIV-2 (B Victoria), n=429."
651668|NCT02214225|O1|Outcome|SCR: bioCSL QIV (18 to < 65 Years)|"bioCSL TIV-1 and bioCSL TIV-2 are pooled for analysis of the A strains. For B/Yamagata TIV=TIV-1, for B/Victoria TIV=TIV-2.~bioCSL QIV, n=835. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421."
651669|NCT02214225|O4|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (≥ 65 Years)|Postvaccination GMT. Pooled TIV (A strains), n=859 TIV-1 (B/YAM), n=430. TIV-2 (B/VIC), n=429.
651670|NCT02214225|O3|Outcome|GMT: bioCSL QIV (≥ 65 Years)|Postvaccination GMT. bioCSL QIV, n=856.
651671|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 or TIV-2 (18 to <65years)|Postvaccination GMT. Pooled TIV (A strains), n=845. TIV-1 (B Yamagata), n=424. TIV-2 (B Victoria), n=421.
651672|NCT02214225|O1|Outcome|GMT: bioCSL QIV (18 to <65 Years)|Postvaccination GMT. bioCSL QIV, n=835.
651673|NCT02214225|O2|Outcome|SCR: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|Pooled TIV (A strains), n=1704. TIV-1 (B Yamagata), n=854. TIV-2 (B Victoria), n=850.
651674|NCT02214225|O1|Outcome|SCR: bioCSL QIV|bioCSL QIV, n=1691.
651675|NCT02214225|O2|Outcome|GMT: Pooled TIV (A Strains) or TIV-1 (B/YAM) or TIV-2 (B/VIC)|"Postvaccination GMT.~Pooled TIV (A strains), N=1704. TIV-1 (B/YAM), N=854. TIV-2 (B/VIC), N=850."
651676|NCT02214225|O1|Outcome|GMT: bioCSL QIV|Postvaccination GMT.
651764|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651677|NCT02214225|E3|Reported Event|Trivalent Influenza Vaccine (TIV-2)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the recommended influenza A (H1N1-, H3N2-like) strains and the alternative B strain for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-2): One 0.5 mL intramuscular dose into the deltoid muscle."
651678|NCT02214225|E2|Reported Event|Trivalent Influenza Vaccine (TIV-1)|"The study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Trivalent Influenza Vaccine (TIV-1): One 0.5 mL intramuscular dose into the deltoid muscle."
651679|NCT02214225|E1|Reported Event|Quadrivalent Influenza Vaccine (QIV)|"The study vaccine is a sterile, thiomersal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~Quadrivalent Influenza Vaccine (QIV): One 0.5 mL intramuscular dose into the deltoid muscle"
651680|NCT02214186|B3|Baseline|Total|Total of all reporting groups
651681|NCT02214186|B2|Baseline|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651682|NCT02214186|B1|Baseline|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651683|NCT02214186|P2|Participant Flow|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651684|NCT02214186|P1|Participant Flow|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651685|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651686|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651687|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651688|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651689|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651690|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651691|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651692|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651693|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651694|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651695|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651696|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651697|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651698|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651699|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651700|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651701|NCT02214186|O2|Outcome|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651702|NCT02214186|O1|Outcome|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651703|NCT02214186|E2|Reported Event|Restrictive Fluid Therapy|"The restrictive group will receive 250 mL of crystalloid solution during cesarean section.~Restrictive Fluid Therapy: The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery."
651704|NCT02214186|E1|Reported Event|Liberal Fluid Therapy|The liberal group will receive 1500 mL of crystalloid solution during the cesarean section. This is the non-intervention arm once that 1500 ml of crystalloid is the amount usually used during caesarean.
651705|NCT02213900|B3|Baseline|Total|Total of all reporting groups
651706|NCT02213900|B2|Baseline|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
651707|NCT02213900|B1|Baseline|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
651708|NCT02213900|P2|Participant Flow|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
651709|NCT02213900|P1|Participant Flow|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
651710|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
651711|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
651712|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
651713|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
651714|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
651715|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
651716|NCT02213900|O2|Outcome|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
651717|NCT02213900|O1|Outcome|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
651718|NCT02213900|E2|Reported Event|Placebo|"Randomized patients will receive a placebo solution immediately after surgery and Q8H following for a total of 4 days.~Placebo"
651719|NCT02213900|E1|Reported Event|Haloperidol|"Randomized patients will receive 0.5mg Haloperidol immediately after surgery and Q8H following the initial dose for a total of 4 days.~Haloperidol: 0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days"
651720|NCT02213666|B1|Baseline|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
651721|NCT02213666|P1|Participant Flow|Intracardiac and Transesophageal Echocardiography|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
651722|NCT02213666|O1|Outcome|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
651723|NCT02213666|E1|Reported Event|Enrolled Patients|The study sample includes patients referred for a clinically indicated ablation procedure of atrial fibrillation or atrial flutter.
651724|NCT02213510|B3|Baseline|Total|Total of all reporting groups
651725|NCT02213510|B2|Baseline|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651726|NCT02213510|B1|Baseline|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651727|NCT02213510|P2|Participant Flow|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651828|NCT02212834|E1|Reported Event|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
651765|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651766|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651833|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
651728|NCT02213510|P1|Participant Flow|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651729|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651730|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651731|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651732|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651733|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651734|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651735|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651736|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651737|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651738|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651739|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651740|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651741|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651761|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651762|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
657474|NCT02156466|B6|Baseline|Total|Total of all reporting groups
651742|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651743|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651744|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651745|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651746|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651747|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651748|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651749|NCT02213510|O2|Outcome|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651750|NCT02213510|O1|Outcome|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651751|NCT02213510|E2|Reported Event|Standard Suture Closure|"The surgeon will perform standard suture closure for the skin layer following CIED procedure.~Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure."
651752|NCT02213510|E1|Reported Event|Zip Surgical Skin Closure Device|"The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.~Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check."
651753|NCT02213250|B1|Baseline|All Participants|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651754|NCT02213250|P2|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651755|NCT02213250|P1|Participant Flow|BeneFIX 50 IU/kg; Age Group: >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by intravenous (IV) infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651756|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651757|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651758|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651759|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651760|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651767|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651768|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651769|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651770|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651771|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651772|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651773|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651774|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651775|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651776|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651777|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; Age Group>=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651778|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651779|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651780|NCT02213250|O2|Outcome|BeneFIX 50 IU/kg; Age Group:>=12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651781|NCT02213250|O1|Outcome|BeneFIX 50 IU/kg; >=6 and <12 Years|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651782|NCT02213250|E1|Reported Event|BeneFIX 50 IU/kg|Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.
651783|NCT02213198|B3|Baseline|Total|Total of all reporting groups
651784|NCT02213198|B2|Baseline|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
651785|NCT02213198|B1|Baseline|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
651786|NCT02213198|P2|Participant Flow|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
651787|NCT02213198|P1|Participant Flow|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
651822|NCT02212834|B1|Baseline|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
651823|NCT02212834|P2|Participant Flow|Breast MRI|Surveillance Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
651824|NCT02212834|P1|Participant Flow|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
651788|NCT02213198|O2|Outcome|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
651829|NCT02212301|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one lens throughout the duration of the study.
651830|NCT02212301|P2|Participant Flow|Lotrafilcon B / Senofilcon A|Subjects that received the lotrafilcon B contact lens in the first period and then received the senofilcon A contact lens in the second period.
651789|NCT02213198|O1|Outcome|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
651790|NCT02213198|O2|Outcome|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
651791|NCT02213198|O1|Outcome|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
651792|NCT02213198|E2|Reported Event|Standard Care|"Standard Care includes individual intake appointments which are traditional in outpatient service and all services of the clinic including counseling, access to a prescriber, care coordination, and access to home visits.~Standard Care: Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases"
651793|NCT02213198|E1|Reported Event|Engagement Focused Care|"Engagement Focused Care which includes all components of standard treatment plus both group Access intake process with its flexibility of scheduling and the SDM intervention~Engagement focused care: Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice."
651794|NCT02213055|B3|Baseline|Total|Total of all reporting groups
651795|NCT02213055|B2|Baseline|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application."
651796|NCT02213055|B1|Baseline|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LiceMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at day seven and day fourteen after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
651797|NCT02213055|P2|Participant Flow|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
651798|NCT02213055|P1|Participant Flow|LICEMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
651825|NCT02212834|O2|Outcome|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
651826|NCT02212834|O1|Outcome|Mammograms|Surveillance mammograms in women with a personal history of breast cancer
651827|NCT02212834|E2|Reported Event|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
653389|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
651831|NCT02212301|P1|Participant Flow|Senofilcon A/ Lotrafilcon B|Subjects that received the senofilcon A contact lens in the first period and then received the lotrafilcon B contact lens in the second period.
651832|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
654816|NCT02185105|O2|Outcome|Comfilcon A Toric|
651799|NCT02213055|O2|Outcome|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application."
651800|NCT02213055|O1|Outcome|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven days and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
651801|NCT02213055|E2|Reported Event|Standard Head Lice Product|"Parents/guardians who do not agree to use the investigational product and choose a standard head lice treatment will be asked to participate in the comparison arm of the study.~Standard Head lice product: The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products. After a baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may choose and purchase any other head lice treatment of their choice. All treatments (investigational and comparison) are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application."
651802|NCT02213055|E1|Reported Event|LiceMD|"Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment.~LICEMD: Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. All participants will be examined for lice count and scalp irritation the day after the first application, and at seven and fourteen days after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any of these examinations, the school nurse will instruct the parent/guardian to retreat."
651803|NCT02212977|B3|Baseline|Total|Total of all reporting groups
651804|NCT02212977|B2|Baseline|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651805|NCT02212977|B1|Baseline|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651806|NCT02212977|P2|Participant Flow|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651807|NCT02212977|P1|Participant Flow|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651808|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651809|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651810|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651811|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651812|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651813|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651814|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651815|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651816|NCT02212977|O2|Outcome|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651817|NCT02212977|O1|Outcome|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651818|NCT02212977|E2|Reported Event|Octylcyanoacrylate|"Skin incision closure with topic skin adhesive Octylcyanoacrylate~Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate"
651819|NCT02212977|E1|Reported Event|Suture|"Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture~Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture"
651820|NCT02212834|B3|Baseline|Total|Total of all reporting groups
651821|NCT02212834|B2|Baseline|Breast MRI|Surveillance breast Magnetic Resonance Imaging (MRI) in women with a personal history of breast cancer
658323|NCT02151994|E14|Reported Event|50 mg (MAD Period)|MAD period
651834|NCT02212301|O2|Outcome|Lotrafilcon B|Subjects that received the lotrafilcon B in either the first or second period of the study.
651835|NCT02212301|O1|Outcome|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
651836|NCT02212301|E2|Reported Event|Lotrafilcon B|Subjects that received the lotrafilcon B contact lens in either the first or second period of the study.
651837|NCT02212301|E1|Reported Event|Senofilcon A|Subjects that received the senofilcon A contact lens in either the first or second period of the study.
651838|NCT02212197|B4|Baseline|Total|Total of all reporting groups
651839|NCT02212197|B3|Baseline|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651840|NCT02212197|B2|Baseline|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651841|NCT02212197|B1|Baseline|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651842|NCT02212197|P3|Participant Flow|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651843|NCT02212197|P2|Participant Flow|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651844|NCT02212197|P1|Participant Flow|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651845|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651846|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651847|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651848|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651849|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651850|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651851|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651852|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651853|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651854|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651855|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651856|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651857|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651858|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651859|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651860|NCT02212197|O3|Outcome|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard® 7.5 mg on Days 0, 28 and 56.
651861|NCT02212197|O2|Outcome|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 7.5 mg on Days 0, 28 and 56.
651862|NCT02212197|O1|Outcome|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 (leuprolide acetate FluidCrystal® injection depot) 3.75 mg on Days 0, 28 and 56.
651863|NCT02212197|E3|Reported Event|Eligard 7.5 mg|Single subcutaneous buttock injections of Eligard 7.5 mg on Days 0, 28 and 56.
651864|NCT02212197|E2|Reported Event|CAM2032 7.5 mg|Single subcutaneous buttock injections of CAM2032 7.5 mg on Days 0, 28 and 56.
651865|NCT02212197|E1|Reported Event|CAM2032 3.75 mg|Single subcutaneous buttock injections of CAM2032 3.75 mg on Days 0, 28 and 56.
651866|NCT02212106|B3|Baseline|Total|Total of all reporting groups
651867|NCT02212106|B2|Baseline|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651868|NCT02212106|B1|Baseline|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
658324|NCT02151994|E13|Reported Event|Placebo (MAD Period)|MAD period
651869|NCT02212106|P2|Participant Flow|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651921|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
654817|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
651870|NCT02212106|P1|Participant Flow|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total hemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651871|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651872|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651873|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651874|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651875|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651876|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651877|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651878|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651879|NCT02212106|O2|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651880|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651881|NCT02212106|O1|Outcome|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651882|NCT02212106|O1|Outcome|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651883|NCT02212106|E2|Reported Event|Comparator Quadrivalent Influenza Virus Vaccine|"The comparator vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season.~Comparator Quadrivalent Influenza Virus Vaccine: Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651920|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651922|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651923|NCT02210091|O1|Outcome|Overall Study Arm|
651884|NCT02212106|E1|Reported Event|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|"The bioCSL study vaccine is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2014/2015 influenza season).~bioCSL Trivalent Influenza Virus Vaccine (CSL TIV): Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection."
651885|NCT02212028|B3|Baseline|Total|Total of all reporting groups
651886|NCT02212028|B2|Baseline|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
651887|NCT02212028|B1|Baseline|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
651888|NCT02212028|P2|Participant Flow|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
651889|NCT02212028|P1|Participant Flow|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
651890|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
651891|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
651892|NCT02212028|O2|Outcome|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
651893|NCT02212028|O1|Outcome|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
651894|NCT02212028|E2|Reported Event|Prasugrel Tablets|Prasugrel 60 mg loading dose whole tablets
651895|NCT02212028|E1|Reported Event|Prasugrel Crush|Prasugrel 60mg loading dose as crushed tablets
651896|NCT02210091|B3|Baseline|Total|Total of all reporting groups
651897|NCT02210091|B2|Baseline|6 to <12 Years Old|
651898|NCT02210091|B1|Baseline|<6 Years Old|
651899|NCT02210091|P2|Participant Flow|6 to <12 Years Old|
651900|NCT02210091|P1|Participant Flow|<6 Years Old|
651901|NCT02210091|O1|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651902|NCT02210091|O3|Outcome|Full Analysis Set|
651903|NCT02210091|O2|Outcome|6 to <12 Years Old|
651904|NCT02210091|O1|Outcome|<6 Years Old|
651905|NCT02210091|O3|Outcome|Full Analysis Set|
651906|NCT02210091|O2|Outcome|6 to <12 Years Old|
651907|NCT02210091|O1|Outcome|<6 Years Old|
651908|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651909|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651910|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651911|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651912|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651913|NCT02210091|O1|Outcome|PK Analysis Set <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651914|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651915|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651916|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651917|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651918|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651919|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651967|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
658325|NCT02151994|E12|Reported Event|400 mg Fed (FE Period)|FE period
651924|NCT02210091|O3|Outcome|PK Analysis Set|Participants who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651925|NCT02210091|O2|Outcome|PK Analysis Set - 6 to <12 Years Old|Participants 6 to <12 years olde who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmcokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651926|NCT02210091|O1|Outcome|PK Analysis Set - <6 Years Old|Participants <6 years old who had been treated with at least 1 dose of ADVATE (60 ±5 IU/kg) and 1 dose of BAX 855 (60 ±5 IU/kg) in the pharmacokinetic (PK) part of the study (prior to prophylactic treatment) and had at least 1 PK concentration available for population PK and non-compartmental analysis.
651927|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651928|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651929|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
651930|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651931|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651932|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
651933|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651934|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651935|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
651936|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651937|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651938|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
651939|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651940|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651941|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
651942|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855.
651943|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651944|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855.
651945|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651946|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651947|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
651948|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651949|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651950|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
651951|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651952|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651953|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
651954|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651955|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651956|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
651957|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651958|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651959|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
651960|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651961|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855.
651962|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
651963|NCT02210091|O3|Outcome|Full Analysis Set|Participants who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
651964|NCT02210091|O2|Outcome|6 to <12 Years Old|Participants 6 to <12 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
651965|NCT02210091|O1|Outcome|<6 Years Old|Participants <6 years old who received at least one dose of BAX 855 in either the Pharmacokinetic (PK) part of the study or the prophylaxis part of the study.
651966|NCT02210091|O3|Outcome|BAX 855 Safety Analysis Set|Participants who received at least one dose of BAX 855.
651968|NCT02210091|O1|Outcome|<6 Years Old|Participants < 6 years old who received at least one dose of BAX 855.
651969|NCT02210091|E2|Reported Event|ADVATE Received Before BAX 855|Participants who received at least 1 dose of ADVATE prior to receiving BAX 855 in the PK part of the study.
651970|NCT02210091|E1|Reported Event|BAX 855 Safety Analysis Set|Participants who received at least 1 dose of BAX 855.
651971|NCT02209766|B5|Baseline|Total|Total of all reporting groups
651972|NCT02209766|B4|Baseline|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
651973|NCT02209766|B3|Baseline|4 g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
651974|NCT02209766|B2|Baseline|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651975|NCT02209766|B1|Baseline|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651976|NCT02209766|P5|Participant Flow|4g D5884 Caucasian|Single dose followed by once daily for 14 consecutive days
651977|NCT02209766|P4|Participant Flow|4g D5844 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
651978|NCT02209766|P3|Participant Flow|4 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651979|NCT02209766|P2|Participant Flow|2 g D5884 Japanese Placebo|Single dose followed by once daily for 14 consecutive days
651980|NCT02209766|P1|Participant Flow|2 g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651981|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
651982|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651983|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651984|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
651985|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651986|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651987|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
651988|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651989|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651990|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
651991|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651992|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651993|NCT02209766|O4|Outcome|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
651994|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
651995|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651996|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651997|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
651998|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
651999|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652000|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
652001|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652002|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652003|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
652004|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652005|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652006|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
652007|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652008|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652009|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
652010|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652011|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652012|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
652013|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652014|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652015|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
652016|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652017|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652018|NCT02209766|O3|Outcome|4g D5885 Caucasian|Single dose followed by once daily for 14 consecutive days
652019|NCT02209766|O2|Outcome|4g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652020|NCT02209766|O1|Outcome|2g D5884 Japanese|Single dose followed by once daily for 14 consecutive days
652021|NCT02209766|E4|Reported Event|Placebo Japanese|Single dose followed by once daily for 14 consecutive days
652022|NCT02209766|E3|Reported Event|4 g D4884 Caucasian|
652023|NCT02209766|E2|Reported Event|4 g D4884 Japanese|
652024|NCT02209766|E1|Reported Event|2 g D4884 Japanese|
652025|NCT02209506|B6|Baseline|Total|Total of all reporting groups
652026|NCT02209506|B5|Baseline|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652027|NCT02209506|B4|Baseline|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652028|NCT02209506|B3|Baseline|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652149|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
654818|NCT02185105|O2|Outcome|Comfilcon A Toric|
652029|NCT02209506|B2|Baseline|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652030|NCT02209506|B1|Baseline|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652031|NCT02209506|P5|Participant Flow|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652032|NCT02209506|P4|Participant Flow|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652033|NCT02209506|P3|Participant Flow|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652034|NCT02209506|P2|Participant Flow|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652035|NCT02209506|P1|Participant Flow|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652036|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652037|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652038|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652039|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652040|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652041|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652042|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652043|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652044|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652045|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652046|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652047|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652048|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652049|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652050|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652143|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652144|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652051|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652052|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652053|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652054|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652055|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652056|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652057|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652058|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652059|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652060|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652061|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652062|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652063|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652064|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652065|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652066|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652067|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652068|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652069|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652070|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652071|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652072|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652073|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652074|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652075|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652076|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652077|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652078|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652079|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652080|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652081|NCT02209506|O3|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652082|NCT02209506|O2|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652083|NCT02209506|O1|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652084|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652085|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652086|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652087|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652088|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652089|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652090|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652091|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652092|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652093|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652094|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652095|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652096|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652097|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652098|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652099|NCT02209506|O5|Outcome|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652100|NCT02209506|O4|Outcome|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652101|NCT02209506|O3|Outcome|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652102|NCT02209506|O2|Outcome|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652103|NCT02209506|O1|Outcome|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652104|NCT02209506|E5|Reported Event|Part B: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652105|NCT02209506|E4|Reported Event|Part B: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652106|NCT02209506|E3|Reported Event|Part A: MLN3126 300 mg|MLN3126 300 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 300 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652107|NCT02209506|E2|Reported Event|Part A: MLN3126 100 mg|MLN3126 100 mg, tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 100 mg, tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652108|NCT02209506|E1|Reported Event|Part A: Placebo|MLN3126 placebo-matching tablet, orally, once on Day 1 of the single dosing period, followed by 1 week washout period, further followed by MLN3126 placebo-matching tablets, orally, once daily from Day 9 up to Day 15 of the 7 day multiple dosing period.
652109|NCT02209454|B1|Baseline|Entire Study Population|Includes groups randomized to receive 25mg DKP.TRIS tablet first and 25mg DKP.TRIS oral solution first.
652110|NCT02209454|P2|Participant Flow|Test IMP First, Then Reference IMP|25mg DKP.TRIS oral solution one single administration in first period and 25mg DKP.TRIS tablet one single administration in second period (after washout period).
652111|NCT02209454|P1|Participant Flow|Reference IMP First, Then Test IMP|25mg DKP.TRIS tablet one single administration in first period and 25mg DKP.TRIS oral solution one single administration in second period (after washout period).
652112|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
652113|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
652114|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
652115|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
652116|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
652117|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
652118|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
652119|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
652120|NCT02209454|O2|Outcome|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
652121|NCT02209454|O1|Outcome|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
652122|NCT02209454|E2|Reported Event|Keral® Tablet|"25mg DKP.TRIS tablet~Keral® tablet: One dose of 25 mg DKP tablet"
652123|NCT02209454|E1|Reported Event|Enantyum® Oral Solution|"25mg DKP.TRIS oral solution~Enantyum® oral solution: One dose of 25 mg DKP oral solution"
652124|NCT02209181|B5|Baseline|Total|Total of all reporting groups
652125|NCT02209181|B4|Baseline|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652126|NCT02209181|B3|Baseline|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652127|NCT02209181|B2|Baseline|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652128|NCT02209181|B1|Baseline|Placebo|Three placebo capsules taken orally
652129|NCT02209181|P4|Participant Flow|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652130|NCT02209181|P3|Participant Flow|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652131|NCT02209181|P2|Participant Flow|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652132|NCT02209181|P1|Participant Flow|Placebo|Three placebo capsules taken orally
652133|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652134|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652135|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652136|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652137|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652138|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652139|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652140|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652141|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652142|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
653390|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
652145|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652146|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652147|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652148|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652150|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652151|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652152|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652153|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652154|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652155|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652156|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652157|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652158|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652159|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652160|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652161|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652162|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652163|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652164|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652165|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652166|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652167|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652168|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652169|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652170|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652171|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652172|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652173|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652174|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652175|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652176|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652177|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652178|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652179|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652180|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652181|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652182|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652183|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652184|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652185|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652186|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652187|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652188|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652189|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652190|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652191|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652192|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652193|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652194|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652195|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652196|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652197|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652198|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652199|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652200|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
658326|NCT02151994|E11|Reported Event|400 mg Fasted (FE Period)|FE period
652201|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652202|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652203|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652204|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652205|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652206|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652207|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652208|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652209|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652210|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652211|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652212|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652213|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652214|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652215|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652216|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652217|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652218|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652219|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652220|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652221|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652222|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652223|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652224|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652225|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652226|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652227|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652228|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652229|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652230|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652231|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652232|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652233|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652234|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652235|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652236|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652237|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652238|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652239|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652240|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652241|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652242|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652243|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652244|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652245|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652246|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652247|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652248|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652249|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652250|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652251|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652252|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652253|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652254|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652255|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652256|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
658327|NCT02151994|E10|Reported Event|2400 mg (SAD)|SAD period
652257|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652258|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652259|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652260|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652261|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652262|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652263|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652264|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652265|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652266|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652267|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652268|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652269|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652270|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652271|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652272|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652273|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652274|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652275|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652276|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652277|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652278|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652279|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652280|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652281|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652282|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652283|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652284|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652285|NCT02209181|O4|Outcome|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652286|NCT02209181|O3|Outcome|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652287|NCT02209181|O2|Outcome|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652288|NCT02209181|O1|Outcome|Placebo|Three placebo capsules taken orally
652289|NCT02209181|E4|Reported Event|JNJ-10450232 1000 mg|One JNJ-10450232 250 mg capsule, one JNJ-10450232 750 mg capsule, and one placebo capsule taken orally
652290|NCT02209181|E3|Reported Event|JNJ-10450232 250 mg|One JNJ-10450232 250 mg capsule and two placebo capsules taken orally
652291|NCT02209181|E2|Reported Event|Acetaminophen 1000 mg|Two encapsulated 500 mg tablets and one placebo capsule taken orally
652292|NCT02209181|E1|Reported Event|Placebo|Three placebo capsules taken orally
652293|NCT02209064|B1|Baseline|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
652294|NCT02209064|P1|Participant Flow|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
652295|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
652296|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
652297|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
652298|NCT02209064|O1|Outcome|EpiAccess|"EpiAccess will be used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
652299|NCT02209064|E1|Reported Event|EpiAccess|"EpiAccess was used to gain access to the normal, non-distended pericardial space in subjects presenting with the need for pericardial access as determined by the patient's physician.~Pericardial access: Access to the pericardium to enable further treatments."
652300|NCT02207907|B3|Baseline|Total|Total of all reporting groups
652301|NCT02207907|B2|Baseline|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652302|NCT02207907|B1|Baseline|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
654984|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
652303|NCT02207907|P2|Participant Flow|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652304|NCT02207907|P1|Participant Flow|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652305|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652306|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652307|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652308|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652309|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652310|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652311|NCT02207907|O2|Outcome|0% Sodium Bicarbonate|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652312|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652313|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652314|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652315|NCT02207907|O2|Outcome|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652316|NCT02207907|O1|Outcome|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652317|NCT02207907|E2|Reported Event|0% Sodium Bicarbonate Dentrifice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652318|NCT02207907|E1|Reported Event|Sodium Bicarbonate Dentrifice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652319|NCT02207829|B3|Baseline|Total|Total of all reporting groups
652320|NCT02207829|B2|Baseline|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
652321|NCT02207829|B1|Baseline|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
652322|NCT02207829|P2|Participant Flow|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
652323|NCT02207829|P1|Participant Flow|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
652324|NCT02207829|O2|Outcome|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
652325|NCT02207829|O1|Outcome|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
652326|NCT02207829|E2|Reported Event|Tiotropium 18 mcg+Placebo QD|Participants received tiotropium (TIO) 18 mcg QD in morning via DPI and placebo QD via nDPI for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via MDI or nebules as rescue medication throughout the study for use as needed.
652327|NCT02207829|E1|Reported Event|Umeclidinium 62.5 mcg+Placebo QD|Participants received umeclidinium (UMEC) inhalation powder 62.5 microgram (mcg) once-daily (QD) in morning via a novel dry powder inhaler (nDPI) and placebo QD via alternative dry powder inhaler (DPI) for 12 weeks (For participants enrolled in Germany, the duration of treatment was 24 weeks). Participants also received albuterol/salbutamol via metered-dose-inhaler (MDI) or nebules as rescue medication throughout the study for use as needed.
652328|NCT02207608|B3|Baseline|Total|Total of all reporting groups
652329|NCT02207608|B2|Baseline|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
652330|NCT02207608|B1|Baseline|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
652331|NCT02207608|P2|Participant Flow|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
652332|NCT02207608|P1|Participant Flow|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
652333|NCT02207608|O2|Outcome|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
652334|NCT02207608|O1|Outcome|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
652335|NCT02207608|E2|Reported Event|Hyaluronic Acid|"Group B receive BCG and HA 40 mg (Cystistat, Mylan, Pittsburgh, PA, U.S.A.).~Hyaluronic Acid~BCG (Immucist®)"
652336|NCT02207608|E1|Reported Event|BCG Alone (Immucist®)|"Group A receive BCG (Immucist® 81 mg, Sanofi-Aventis Group) alone~BCG (Immucist®)"
652337|NCT02207478|B3|Baseline|Total|Total of all reporting groups
652442|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
654819|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
652338|NCT02207478|B2|Baseline|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652339|NCT02207478|B1|Baseline|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652340|NCT02207478|P2|Participant Flow|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652341|NCT02207478|P1|Participant Flow|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System.~ENB: ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652342|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652343|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652344|NCT02207478|O2|Outcome|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652345|NCT02207478|O1|Outcome|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652346|NCT02207478|E2|Reported Event|GS-TBLB-X-ray Group|"The GS is introduced into the lesion via the working channel of a bronchoscope with radiographic fluoroscopy. Once the location of the lesion is identified by fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652347|NCT02207478|E1|Reported Event|ENB-GS-TBLB-X-ray Group|"The guide sheath(GS) is introduced into the lesion via Electromagnetic Navigation System. The locatable guide(LG) and GS are confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained with fluoroscopic guidance.~GS-TBLB-X-ray: A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance."
652348|NCT02207413|B7|Baseline|Total|Total of all reporting groups
652349|NCT02207413|B6|Baseline|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652350|NCT02207413|B5|Baseline|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652438|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652475|NCT02206776|B2|Baseline|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
653183|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
652351|NCT02207413|B4|Baseline|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652352|NCT02207413|B3|Baseline|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652353|NCT02207413|B2|Baseline|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652354|NCT02207413|B1|Baseline|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652355|NCT02207413|P6|Participant Flow|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652356|NCT02207413|P5|Participant Flow|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652357|NCT02207413|P4|Participant Flow|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652358|NCT02207413|P3|Participant Flow|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652359|NCT02207413|P2|Participant Flow|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652360|NCT02207413|P1|Participant Flow|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652361|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652362|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652363|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652469|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
652364|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652365|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652366|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652367|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652368|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652369|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652370|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652371|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652372|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652373|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652439|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652470|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652374|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652375|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6m-<5y Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652376|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6m-<5y Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to <5 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652377|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652378|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652379|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652380|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652381|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652382|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652383|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652440|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652471|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
652384|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652385|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652386|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652387|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652388|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652389|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652390|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652391|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652392|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652393|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652394|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652441|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652472|NCT02207400|E2|Reported Event|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652395|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652396|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652397|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652398|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652399|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652400|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652401|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652402|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652403|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652404|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652405|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652406|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652407|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652408|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652409|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652467|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
652468|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652410|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652411|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652412|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652413|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652414|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652415|NCT02207413|O2|Outcome|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652416|NCT02207413|O1|Outcome|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652417|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652418|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652419|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652420|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652421|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652422|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652423|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652424|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652425|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652426|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652427|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652428|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652429|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652430|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652431|NCT02207413|O2|Outcome|Influsplit Tetra_LP 5-17y Group|Subjects in the Influsplit Tetra_LP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652432|NCT02207413|O1|Outcome|Influsplit Tetra_IP 5-17y Group|Subjects in the Influsplit Tetra_IP group aged between 5 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652433|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-4y Group|Subjects in the Influsplit Tetra_LP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652434|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-4y Group|Subjects in the Influsplit Tetra_IP group aged between 3 to 4 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652435|NCT02207413|O2|Outcome|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652436|NCT02207413|O1|Outcome|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to <9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652437|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652443|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652444|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652445|NCT02207413|O2|Outcome|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652446|NCT02207413|O1|Outcome|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652447|NCT02207413|E6|Reported Event|Influsplit Tetra_LP 6-35m Group|Subjects in the Influsplit Tetra_LP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Influsplit Tetra™ vaccine produced by LP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652448|NCT02207413|E5|Reported Event|Influsplit Tetra_IP 6-35m Group|Subjects in the Influsplit Tetra_IP group aged between 6 months to 35 months received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Influsplit Tetra™ vaccine produced by IP was administered intramuscularly the anterolateral region of left thigh for subjects below 12 months of age and in the deltoid region of left or non-dominant arm in subjects ≥ 12 months of age (Day 0) and in the anterolateral region of right thigh for subjects below 12 months of age and in the deltoid region of right or dominant arm in subjects ≥ 12 months of age (Day 28).
652449|NCT02207413|E4|Reported Event|Influsplit Tetra_LP 3-17y Group|Subjects in the Influsplit Tetra_LP group aged between 3 years to &lt;9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by licensed process (LP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by LP at Day 0. Influsplit Tetra™ vaccine produced by LP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652450|NCT02207413|E3|Reported Event|Influsplit Tetra_IP 3-17y Group|Subjects in the Influsplit Tetra_IP group aged between 3 years to &lt;9 years received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Influsplit Tetra™ vaccine produced by investigational process (IP). Subjects aged 9-17 years received only 1 dose of Influsplit Tetra™ vaccine produced by IP at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm (Day 0) and in the deltoid region of right or dominant arm (Day 28).
652451|NCT02207413|E2|Reported Event|Influsplit Tetra_LP Adult Group|Subjects in the Influsplit Tetra_LP aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by currently licensed process (LP) at Day 0. Influsplit Tetra™ vaccine produced by currently LP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652452|NCT02207413|E1|Reported Event|Influsplit Tetra_IP Adult Group|Subjects in the Influsplit Tetra_IP group aged between 18 to 49 years received 1 dose of Influsplit Tetra™ vaccine produced by investigational process (IP) at Day 0. Influsplit Tetra™ vaccine produced by IP was administered intramuscularly in the deltoid region of left or non-dominant arm.
652453|NCT02207400|B3|Baseline|Total|Total of all reporting groups
652454|NCT02207400|B2|Baseline|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652455|NCT02207400|B1|Baseline|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
652456|NCT02207400|P2|Participant Flow|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652457|NCT02207400|P1|Participant Flow|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
652458|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652459|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm)fluoride as sodium fluoride
652460|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652461|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
652462|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652463|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
652464|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652465|NCT02207400|O1|Outcome|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental dentifrice containing sodium bicarbonate plus 1150 ppm fluoride as sodium fluoride
652466|NCT02207400|O2|Outcome|Sodium Fluoride Dentifrice|Toothpaste containing 1100 ppm fluoride as sodium fluoride
652473|NCT02207400|E1|Reported Event|Sodium Bicarbonate and Sodium Fluoride Dentifrice|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 ppm fluoride as sodium fluoride
652474|NCT02206776|B3|Baseline|Total|Total of all reporting groups
654820|NCT02185105|O2|Outcome|Comfilcon A Toric|
652476|NCT02206776|B1|Baseline|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
652477|NCT02206776|P2|Participant Flow|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
652478|NCT02206776|P1|Participant Flow|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
652479|NCT02206776|O2|Outcome|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
652480|NCT02206776|O1|Outcome|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
652481|NCT02206776|E2|Reported Event|Ketamine|"A single dose of intranasal ketamine up to 50 mg~Intranasal Ketamine: A single dose of intranasal ketamine up to 50 mg"
652482|NCT02206776|E1|Reported Event|Midazolam|"A single dose of intranasal midazolam up to 4 mg~Intranasal Midazolam: A single dose of intranasal Midazolam up to 4 mg"
652483|NCT02206607|B1|Baseline|All Participants|Participants received at least 1 dose of PF-04937319.
652484|NCT02206607|P5|Participant Flow|Sequence DCAB: PF-04937319 330 mg MR3 First|Participants received PF-04937319 330 mg MR3, followed by PF-04937319 300 mg MR2, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 250 mg MR1. There was a 5 to 10-day washout between dosing across the 4 regimens.
652485|NCT02206607|P4|Participant Flow|Sequence CBDA: PF-04937319 300 mg MR2 First|Participants received PF-04937319 300 mg MR2, followed by PF-04937319 250 mg MR1, followed by PF-04937319 330 mg MR3, followed by PF-04937319 150+100 mg IR. There was a 5 to 10-day washout between dosing across the 4 regimens.
652486|NCT02206607|P3|Participant Flow|Sequence BACD: PF-04937319 250 mg MR1 First|Participants received PF-04937319 MR1 250 mg, followed by PF-04937319 150+100 mg IR, followed by PF-04937319 300 mg MR2, followed by PF-04937319 330 mg MR3. There was a 5 to 10-day washout between dosing across the 4 regimens.
652487|NCT02206607|P2|Participant Flow|Sequence ADBC: PF-04937319 150+100 mg IR First|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch, followed by PF-04937319 modified-release formulation #3 (MR3) 330 mg, followed by PF-04937319 modified-release formulation #1 (MR1) 250 mg, followed by PF-04937319 modified-release formulation #2 (MR2) 300 mg. There was a 5 to 10-day washout between dosing across the 4 regimens.
652488|NCT02206607|P1|Participant Flow|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment sequences.
652489|NCT02206607|O5|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652490|NCT02206607|O4|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652491|NCT02206607|O3|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652492|NCT02206607|O2|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652493|NCT02206607|O1|Outcome|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
652494|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652495|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652496|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652497|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652498|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652499|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652500|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652501|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652502|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652503|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
654985|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
652504|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
653184|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
652505|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652506|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652507|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652508|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652509|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652510|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652511|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652512|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652513|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652514|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652515|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652516|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652517|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652518|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652519|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652520|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652521|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652522|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652523|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652524|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652525|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652526|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652527|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652528|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652529|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652530|NCT02206607|O4|Outcome|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652531|NCT02206607|O3|Outcome|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652532|NCT02206607|O2|Outcome|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
653179|NCT02201901|B1|Baseline|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
652660|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652533|NCT02206607|O1|Outcome|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652534|NCT02206607|E5|Reported Event|PF-04937319 330 mg MR3|Participants received modified-release formulation#3 administered orally at 330 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652535|NCT02206607|E4|Reported Event|PF-04937319 300 mg MR2|Participants received modified-release formulation#2 administered orally at 300 mg with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652536|NCT02206607|E3|Reported Event|PF-04937319 250 mg MR1|Participants received modified-release formulation #1 administered orally at 250 mg tablet with morning meal. There was a 5 to 10-day washout between dosing across the 4 regimens.
652537|NCT02206607|E2|Reported Event|PF-04937319 150+100 mg IR|Participants received immediate-release material sparing tablet (IR MST) administered orally at 150 mg with morning meal and 100 mg with lunch. There was a 5 to 10-day washout between dosing across the 4 regimens.
652538|NCT02206607|E1|Reported Event|Metformin Run-In|Participants received open-label, sponsor-provided metformin tablet(s) orally at a dose in multiples of 500 mg (minimum dose 500 mg, maximum dose 2500 mg). Participants who met eligibility criteria on metformin were then randomized to 1 of 4 treatment regimens.
652539|NCT02205814|B5|Baseline|Total|Total of all reporting groups
652540|NCT02205814|B4|Baseline|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
652541|NCT02205814|B3|Baseline|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
652542|NCT02205814|B2|Baseline|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
652543|NCT02205814|B1|Baseline|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
652544|NCT02205814|P4|Participant Flow|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
652545|NCT02205814|P3|Participant Flow|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
652546|NCT02205814|P2|Participant Flow|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
652547|NCT02205814|P1|Participant Flow|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
652548|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
652549|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
652550|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
652551|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
652552|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
652553|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
652554|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
652555|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
652556|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
652557|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
652558|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
652559|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
652560|NCT02205814|O4|Outcome|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
652561|NCT02205814|O3|Outcome|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
652562|NCT02205814|O2|Outcome|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
652563|NCT02205814|O1|Outcome|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
652564|NCT02205814|E4|Reported Event|PLACEBO|"Drug: solution for intra-articular injection~Placebo comparator: Single intra-articular injection of placebo"
652565|NCT02205814|E3|Reported Event|Fasitibant High Dose|"Drug: solution for intra-articular injection~Fasitibant- high dose: Single intra-articular injection of high dose of fasitibant"
652566|NCT02205814|E2|Reported Event|Fasitibant Intermediate Dose|"Drug: solution for intra-articular injection~Fasitibant- intermediate dose: Single intra-articular injection of intermediate dose of fasitibant"
652567|NCT02205814|E1|Reported Event|Fasitibant Low Dose|"Drug: solution for intra-articular injection~Fasitibant- low dose: Single intra-articular injection of low dose of fasitibant"
652568|NCT02205476|B3|Baseline|Total|Total of all reporting groups
652658|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652569|NCT02205476|B2|Baseline|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652570|NCT02205476|B1|Baseline|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652571|NCT02205476|P2|Participant Flow|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652572|NCT02205476|P1|Participant Flow|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652573|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652574|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652575|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652576|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652577|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
652578|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
652579|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
652580|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
652581|NCT02205476|O2|Outcome|Group 2: PF­-06473871/Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
652582|NCT02205476|O1|Outcome|Group 1: PF­-06473871/Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery and were planned to receive scar revision surgery in part B of the study.
652583|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
658328|NCT02151994|E9|Reported Event|1600 mg (SAD)|SAD period
652584|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652585|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652586|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652587|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652588|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652589|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652590|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652591|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652592|NCT02205476|O3|Outcome|Group 2: PF-06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652593|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652594|NCT02205476|O1|Outcome|Group 1: PF­06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652595|NCT02205476|O4|Outcome|Group 2: Placebo: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast and 3 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652596|NCT02205476|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 on one breast at Week 2, 5 and 8 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652597|NCT02205476|O2|Outcome|Group 1: Placebo: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 on another breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) were assessed for efficacy in the part A of the study, 1 year post their initial scar revision surgery.
652598|NCT02205476|O1|Outcome|Group 1: PF­-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11 in study B5301001 (NCT01730339) and were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652599|NCT02205476|E2|Reported Event|Group 2: PF­-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652600|NCT02205476|E1|Reported Event|Group 1: PF­-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars who received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast in study B5301001 (NCT01730339) were assessed for efficacy in part A of the study, 1 year post their initial scar revision surgery.
652601|NCT02205333|B10|Baseline|Total|Total of all reporting groups
652602|NCT02205333|B9|Baseline|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
653180|NCT02201901|P3|Participant Flow|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
658329|NCT02151994|E8|Reported Event|800 mg (SAD)|SAD period
652603|NCT02205333|B8|Baseline|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652604|NCT02205333|B7|Baseline|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652605|NCT02205333|B6|Baseline|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652606|NCT02205333|B5|Baseline|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652607|NCT02205333|B4|Baseline|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652608|NCT02205333|B3|Baseline|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652609|NCT02205333|B2|Baseline|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652610|NCT02205333|B1|Baseline|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652611|NCT02205333|P9|Participant Flow|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652612|NCT02205333|P8|Participant Flow|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652613|NCT02205333|P7|Participant Flow|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652614|NCT02205333|P6|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652615|NCT02205333|P5|Participant Flow|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652616|NCT02205333|P4|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652617|NCT02205333|P3|Participant Flow|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652618|NCT02205333|P2|Participant Flow|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652619|NCT02205333|P1|Participant Flow|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652620|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652621|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652622|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652623|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652624|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652625|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652626|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652627|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652628|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652629|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652659|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
658330|NCT02151994|E7|Reported Event|400 mg (SAD)|SAD period
652630|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652631|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652632|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652633|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652634|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652635|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652636|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652637|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652638|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652639|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652640|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652641|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652642|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652643|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652644|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652645|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652646|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652647|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652648|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652649|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652650|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652651|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652652|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652653|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652654|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652655|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652656|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652657|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
658331|NCT02151994|E6|Reported Event|200 mg (SAD)|SAD period
652661|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652662|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652663|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652664|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652665|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652666|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652667|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652668|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652669|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652670|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652671|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652672|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652673|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652674|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652675|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652676|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652677|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652678|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652679|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652680|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652681|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652682|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652683|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652684|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652685|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652686|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652687|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652745|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652688|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652689|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652690|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652691|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652692|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652693|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652694|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652695|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652696|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652697|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652698|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652699|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652700|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652701|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652702|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652703|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652704|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652705|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652706|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652707|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652708|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652709|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652710|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652711|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652712|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652713|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652714|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652715|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652854|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652855|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
653182|NCT02201901|P1|Participant Flow|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (Sofosbuvir/velpatasvir) (400/100 mg) fixed dose combination (FDC) tablet once daily for 12 weeks
654821|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
652716|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652717|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652718|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652719|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652720|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652721|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652722|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652723|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652724|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652725|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652726|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652727|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652728|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652729|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652730|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652731|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652732|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652733|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652734|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652735|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652736|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652737|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652738|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652739|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652740|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652741|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652742|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652743|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652744|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652746|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652747|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652748|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652749|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652750|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652751|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652752|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652753|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652754|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652755|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652756|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652757|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652758|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652759|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652760|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652761|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652762|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652763|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652764|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652765|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652766|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652767|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652768|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652769|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652770|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652771|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652772|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652773|NCT02205333|O9|Outcome|MEDI6469 10 mg/kg + Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652856|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652774|NCT02205333|O8|Outcome|MEDI6469 2 mg/kg+ Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652775|NCT02205333|O7|Outcome|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652776|NCT02205333|O6|Outcome|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652777|NCT02205333|O5|Outcome|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652778|NCT02205333|O4|Outcome|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652779|NCT02205333|O3|Outcome|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652780|NCT02205333|O2|Outcome|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652781|NCT02205333|O1|Outcome|MEDI6469 6 mg/kg|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652782|NCT02205333|E9|Reported Event|MEDI6469 10 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 10 mg/kg as a repeat IV administration on Day 3, then Q4W for 11 doses, or until confirmed CR plus 1 cycle, or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652783|NCT02205333|E8|Reported Event|MEDI6469 2 mg/kg+Rituximab 375 mg/m^2|Participants received MEDI6469 2 mg/kg as a repeat IV administration on Day 3 then Q4W for 11 doses, or until confirmed complete response (CR) plus 1 cycle or PD plus rituximab 375 mg/m^2 as IV administration on Days 1, 8, and 29; then Q4W for 10 doses, or until confirmed CR plus 1 cycle, or PD
652784|NCT02205333|E7|Reported Event|MEDI6469 10 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652785|NCT02205333|E6|Reported Event|MEDI6469 2 mg/kg+Durvalumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 10 mg/kg as IV administration on Day 1, then Q2W for 12 months or until PD
652786|NCT02205333|E5|Reported Event|MEDI6469 2 mg/kg+Durvalumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus durvalumab 3 mg/kg as IV administration on Day 1, then every 2 weeks (Q2W) for 12 months or until PD
652787|NCT02205333|E4|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 10 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 10 mg/kg as IV administration on Day 1, then Q4W for 6 doses, after which Q12W for 2 doses or until PD
652788|NCT02205333|E3|Reported Event|MEDI6469 2 mg/kg+Tremelimumab 3 mg/kg|Participants received MEDI6469 2 mg/kg as a single IV administration on Day 1 plus tremelimumab 3 mg/kg as IV administration on Day 1, then every 4 weeks (Q4W) for 6 doses, after which every 12 weeks (Q12W) for 2 doses or until PD
652789|NCT02205333|E2|Reported Event|MEDI6469 10 mg/kg|Participants received MEDI6469 10 mg/kg as a single IV administration on Day 1
652790|NCT02205333|E1|Reported Event|MEDI6469 6 Milligram/Kilogram (mg/kg)|Participants received MEDI6469 6 mg/kg as a single intravenous (IV) administration on Day 1
652791|NCT02204748|B1|Baseline|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652792|NCT02204748|P1|Participant Flow|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652793|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652794|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652795|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652796|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652797|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652798|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652799|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652800|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652857|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652858|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652801|NCT02204748|O1|Outcome|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652802|NCT02204748|E1|Reported Event|DePuy Attune PS FB TKA|"Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system implanted by a single surgeon at least three months post-operative.~DePuy Attune posterior stabilizing fixed bearing knee system"
652803|NCT02204657|B3|Baseline|Total|Total of all reporting groups
652804|NCT02204657|B2|Baseline|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
652805|NCT02204657|B1|Baseline|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
652806|NCT02204657|P2|Participant Flow|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
652807|NCT02204657|P1|Participant Flow|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
652808|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
652809|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
652810|NCT02204657|O2|Outcome|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
652811|NCT02204657|O1|Outcome|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
652812|NCT02204657|E2|Reported Event|Control|Patients in this arm will not receive any Continuous Glucose Monitoring System( CGMS) and the insulin titration will be made based on their fingerstick sugar readings.
652813|NCT02204657|E1|Reported Event|Continuous Glucose Monitoring System|"Patients in this arm will receive Continuous Glucose Monitoring System (CGMS) at 28,32 and 36 weeks of gestation and their insulin titrated according to the CGMS results.~Continuous Glucose Monitoring System: Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings"
652814|NCT02204579|B1|Baseline|NPSP795|
652815|NCT02204579|P1|Participant Flow|NPSP795|
652816|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652817|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652818|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652819|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652820|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
652821|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652822|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652823|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652824|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652825|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
652826|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652827|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652828|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652829|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652830|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
652831|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652832|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652833|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652834|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652835|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
652836|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652837|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652838|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652839|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652840|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
652841|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652842|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652843|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652844|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652845|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
652846|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652847|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652848|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652849|NCT02204579|O2|Outcome|NPSP795 on Day 2 (15 mg/3.5 Hours)|
652850|NCT02204579|O1|Outcome|NPSP795 on Day 1 (5 mg/10 Minutes)|
652851|NCT02204579|O5|Outcome|NPSP795 on Day 4 (50 mg/3.5 Hours)|
652852|NCT02204579|O4|Outcome|NPSP795 on Day 4 (30 mg/3.5 Hours)|
652853|NCT02204579|O3|Outcome|NPSP795 on Day 3 (30 mg/3.5 Hours)|
652867|NCT02204449|B2|Baseline|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
652868|NCT02204449|B1|Baseline|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
652869|NCT02204449|P2|Participant Flow|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
652870|NCT02204449|P1|Participant Flow|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
652871|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
652872|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
652873|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
652874|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
652875|NCT02204449|O2|Outcome|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
652876|NCT02204449|O1|Outcome|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
652877|NCT02204449|E2|Reported Event|Usual Care|Cardiac inpatients will not be visited by the cardiac rehabilitation (CR) peer mentor. They will instead receive usual care involving care from health care providers (i.e. nurses and doctors) as well as allied health professionals such as physiotherapists. In addition, some may be visited by general volunteer cardiac mentors.
653181|NCT02201901|P2|Participant Flow|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
652878|NCT02204449|E1|Reported Event|Cardiac Rehabilitation Peer Mentorship|"Trained cardiac rehabilitation (CR) peer mentors will visit cardiac inpatients in the hospital to provide patients with information on CR. During this visit the CR mentors will discuss the benefits of CR, stress the importance of getting a referral before leaving the hospital, and arrange a time in the near future to call the patient/participant at home to find out about their progress in terms of CR.~One week after the patient has been discharged the peer mentor will mail a card to the patient to wish them well and remind them of the planned call. Two weeks after the patient has been discharged the peer mentor will call the patient at home to determine if they were referred and if they are able and planning to attend CR. If any barriers are stated by the patient the peer mentors will work with the patient to develop possible solutions to those barriers. Patients can request up to two additional phone calls from the peer mentors.~Cardiac Rehabilitation Peer Mentorship"
652879|NCT02204007|B3|Baseline|Total|Total of all reporting groups
652880|NCT02204007|B2|Baseline|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
652881|NCT02204007|B1|Baseline|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
652882|NCT02204007|P2|Participant Flow|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
652883|NCT02204007|P1|Participant Flow|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
652884|NCT02204007|O2|Outcome|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
652885|NCT02204007|O1|Outcome|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
652886|NCT02204007|O2|Outcome|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
652887|NCT02204007|O1|Outcome|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
652888|NCT02204007|E2|Reported Event|Standard of Care Preoperative Imaging|Patients receiving standard of care preoperative planning prior to total hip arthroplasty.
652889|NCT02204007|E1|Reported Event|3D Imaging, Surrogate Bone Model|"3D imaging & surrogate bone model~3D imaging & surrogate bone model: 3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging"
652890|NCT02203916|B4|Baseline|Total|Total of all reporting groups
652891|NCT02203916|B3|Baseline|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652892|NCT02203916|B2|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652893|NCT02203916|B1|Baseline|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652894|NCT02203916|P3|Participant Flow|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652895|NCT02203916|P2|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652896|NCT02203916|P1|Participant Flow|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652897|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652898|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652899|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652900|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652901|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652902|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652903|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652904|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652905|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652906|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652907|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652908|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652909|NCT02203916|O3|Outcome|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652910|NCT02203916|O2|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652911|NCT02203916|O1|Outcome|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652912|NCT02203916|E3|Reported Event|Azilsartan Medoxomil 80 mg|Azilsartan medoxomil 80 mg, tablets, orally, once daily for 6 weeks.
652913|NCT02203916|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, once daily for 6 weeks.
652914|NCT02203916|E1|Reported Event|Placebo|Azilsartan medoxomil placebo-matching tablets, orally, once daily for 6 weeks.
652915|NCT02203786|B5|Baseline|Total|Total of all reporting groups
652916|NCT02203786|B4|Baseline|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
652917|NCT02203786|B3|Baseline|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
652918|NCT02203786|B2|Baseline|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652919|NCT02203786|B1|Baseline|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652920|NCT02203786|P4|Participant Flow|Fluphenazine - Controls|"Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
652921|NCT02203786|P3|Participant Flow|Haloperidol - Controls|"Dose 1: 3 mg haloperidol (3 capsules @ 1 mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses). Dexedrine: Dose/maximum dose 20 mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
652922|NCT02203786|P2|Participant Flow|Fluphenazine - Pathological Gamblers|"Dose 1: 3 mg fluphenazine (3 capsules @ 1 mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
652923|NCT02203786|P1|Participant Flow|Haloperidol - Pathological Gamblers|"Dose 1: 3 mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine. Response measured to 15 min session of a commercial slot machine game.~Haloperidol: Dose/maximum dose 3 mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
652924|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
652925|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
652926|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652927|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652928|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 control subjects were enrolled in this arm.
652929|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 control subjects were enrolled in this arm.
652930|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652931|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652932|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
652933|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
652934|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652935|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652936|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
652937|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
652938|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652939|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652940|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
652941|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
652942|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652943|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652944|NCT02203786|O4|Outcome|Fluphenazine - Controls|A total of 15 controls were enrolled in this arm.
652945|NCT02203786|O3|Outcome|Haloperidol - Controls|A total of 15 controls were enrolled in this arm.
652946|NCT02203786|O2|Outcome|Fluphenazine - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652947|NCT02203786|O1|Outcome|Haloperidol - Pathological Gamblers|A total of 15 pathological gamblers were enrolled in this arm.
652974|NCT02203578|B1|Baseline|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652975|NCT02203578|P1|Participant Flow|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
653382|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
652948|NCT02203786|E4|Reported Event|Fluphenazine - Controls|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
652949|NCT02203786|E3|Reported Event|Haloperidol - Controls|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
652950|NCT02203786|E2|Reported Event|Fluphenazine - Pathological Gamblers|"Drug sequence 1 (fluphenazine on day 1 of each phase), or drug sequence 2 (fluphenazine on day 2 of each phase).~Dose 1: 3 mg fluphenazine (3 capsules @ 1mg each) OR 3 visually identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when participants reach peak blood levels for dose 1. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).~All participants will receive 2 doses of Dexedrine (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses."
652951|NCT02203786|E1|Reported Event|Haloperidol - Pathological Gamblers|"Drug sequence 1 (haloperidol on day 1 of each phase), or drug sequence 2 (haloperidol on day 2 of each phase).~Dose 1: 3mg haloperidol (3 capsules @ 1mg each) OR 3 identical placebo capsules on alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing). Dose 2: administered when peak blood levels for dose 1 are reached. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1. On sessions 3 and 4 (Phase II), the dose will consist of 2 identical capsules each containing 10 mg dexedrine.~Response measured to 15 min session of a commercial slot machine game. Haloperidol: Dose/maximum dose 3mg oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between doses).~Dexedrine: Dose/maximum dose 20mg oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between doses."
652952|NCT02203747|B3|Baseline|Total|Total of all reporting groups
652953|NCT02203747|B2|Baseline|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
652954|NCT02203747|B1|Baseline|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
652955|NCT02203747|P2|Participant Flow|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with bilateral non-toric IOL~Administration of patient self-assessment"
652956|NCT02203747|P1|Participant Flow|Pseudophakic Implanted With Toric IOL|"Subjects implanted with bilateral toric IOL~Administration of patient self-assessment"
652957|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
652958|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
652959|NCT02203747|O2|Outcome|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
652960|NCT02203747|O1|Outcome|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
652961|NCT02203747|E2|Reported Event|Pseudophakic Implanted With Non-toric IOL|"Subjects implanted with non-toric IOL~Administration of patient self-assessment"
652962|NCT02203747|E1|Reported Event|Pseudophakic Implanted With Toric IOL|"Subjects implanted with toric IOL~Administration of patient self-assessment"
652963|NCT02203721|B3|Baseline|Total|Total of all reporting groups
652964|NCT02203721|B2|Baseline|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
652965|NCT02203721|B1|Baseline|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
652966|NCT02203721|P2|Participant Flow|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
652967|NCT02203721|P1|Participant Flow|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
652968|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
652969|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
652970|NCT02203721|O2|Outcome|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
652971|NCT02203721|O1|Outcome|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
652972|NCT02203721|E2|Reported Event|TECNIS Intraocular Lens, Model ZCB00|Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
652973|NCT02203721|E1|Reported Event|TECNIS Intraocular Lens, Model ZXR00|Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
652976|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652977|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652978|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652979|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652980|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652981|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652982|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652983|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652984|NCT02203578|O1|Outcome|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652985|NCT02203578|E1|Reported Event|Supportive Care (Romidepsin)|"Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV~laboratory biomarker analysis: Correlative studies"
652986|NCT02203162|B1|Baseline|Subjects|all subjects underwent cough challenge testing at baseline and after e-cig exposure
652987|NCT02203162|P1|Participant Flow|Electronic Cigarette Exposure|30 healthy subjects-adult nonsmokers
652988|NCT02203162|O1|Outcome|Electronic Cigarette Exposure|30 subjects-healthy adult nonsmokers
652989|NCT02203162|E1|Reported Event|Subjects|30 subjects-adult nonsmokers
652990|NCT02203149|B6|Baseline|Total|Total of all reporting groups
652991|NCT02203149|B5|Baseline|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
652992|NCT02203149|B4|Baseline|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
652993|NCT02203149|B3|Baseline|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
652994|NCT02203149|B2|Baseline|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
652995|NCT02203149|B1|Baseline|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
652996|NCT02203149|P5|Participant Flow|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
652997|NCT02203149|P4|Participant Flow|Part 2 Non-cirrhotic Deferred: Placebo► Grazoprevir + Elbasvir|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up. Afterwards, participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks during the open-label period of Part 2.
652998|NCT02203149|P3|Participant Flow|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
652999|NCT02203149|P2|Participant Flow|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653000|NCT02203149|P1|Participant Flow|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653001|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653158|NCT02201940|B2|Baseline|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
653159|NCT02201940|B1|Baseline|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653002|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
653003|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653004|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653005|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period of Part 2, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks.
653006|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653007|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
653008|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2.
653009|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
653010|NCT02203149|O3|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
653011|NCT02203149|O2|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
653012|NCT02203149|O1|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2.
653013|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653014|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653015|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653016|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653017|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
653018|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
653019|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1.
653020|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1.
653021|NCT02203149|O5|Outcome|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653022|NCT02203149|O4|Outcome|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
653023|NCT02203149|O3|Outcome|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic treatment-naïve participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653024|NCT02203149|O2|Outcome|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653025|NCT02203149|O1|Outcome|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653026|NCT02203149|E6|Reported Event|Part 2 Cirrhotic: Grazoprevir + Elbasvir|Cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653027|NCT02203149|E5|Reported Event|Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir|During the open-label period, non-cirrhotic participants in the Deferred Treatment Arm take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks and are followed-up for 24 weeks. One participant who received placebo during the blinded period did not receive active treatment during the open-label period.
653028|NCT02203149|E4|Reported Event|Part 2 Non-cirrhotic Deferred: Placebo|Non-cirrhotic participants in the Deferred Treatment Arm take dose-matched placebo p.o. q.d. for 12 weeks during the blinded period of Part 2 followed by a 4-week follow-up.
653160|NCT02201940|P2|Participant Flow|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
658332|NCT02151994|E5|Reported Event|100 mg (SAD)|SAD period
653029|NCT02203149|E3|Reported Event|Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir and 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 2, and are followed-up for 24 weeks during the open-label period of Part 2.
653030|NCT02203149|E2|Reported Event|Part 1 Grazoprevir 100 mg + Elbasvir|Non-cirrhotic participants take 100 mg grazoprevir in combination with 50 mg elbasvir p.o. q.d. for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653031|NCT02203149|E1|Reported Event|Part 1 Grazoprevir 50 mg + Elbasvir|Non-cirrhotic participants take 50 mg grazoprevir in combination with 50 mg elbasvir orally (p.o.) once daily (q.d.) for 12 weeks during the blinded period of Part 1 and are followed-up for 24 weeks during the open-label period of Part 1.
653032|NCT02202785|B4|Baseline|Total|Total of all reporting groups
653033|NCT02202785|B3|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653034|NCT02202785|B2|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653035|NCT02202785|B1|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653036|NCT02202785|P3|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653037|NCT02202785|P2|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653038|NCT02202785|P1|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653039|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653040|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653041|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653042|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653043|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653044|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653045|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653046|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653047|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle,for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653048|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653049|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653050|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle,for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653051|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653052|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653053|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653054|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653055|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653161|NCT02201940|P1|Participant Flow|SOF/VEL|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
653056|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653057|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653058|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653059|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653060|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653061|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653062|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653063|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653064|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653065|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653066|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653067|NCT02202785|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 6 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653162|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
653163|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653164|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
653165|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
658333|NCT02151994|E4|Reported Event|50 mg (SAD)|SAD period
653068|NCT02202785|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653069|NCT02202785|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 4 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653070|NCT02202785|E1|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 10 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653071|NCT02202759|B4|Baseline|Total|Total of all reporting groups
653072|NCT02202759|B3|Baseline|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653073|NCT02202759|B2|Baseline|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653074|NCT02202759|B1|Baseline|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653075|NCT02202759|P3|Participant Flow|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653076|NCT02202759|P2|Participant Flow|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653077|NCT02202759|P1|Participant Flow|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653078|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653079|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653166|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
653167|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653168|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
653169|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
658334|NCT02151994|E3|Reported Event|25 mg (SAD)|SAD period
653080|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653081|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653082|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653083|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653084|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653085|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653086|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653087|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653088|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653089|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653090|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653091|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653092|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653170|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
658335|NCT02151994|E2|Reported Event|5 mg (SAD)|SAD period
653093|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653094|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653095|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653096|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653097|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653098|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653099|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653100|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653101|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653102|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653103|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653104|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653171|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653172|NCT02201940|O2|Outcome|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
653173|NCT02201940|O1|Outcome|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653174|NCT02201940|E2|Reported Event|Placebo|SOF/VEL placebo tablet administered orally once daily for 12 weeks
658336|NCT02151994|E1|Reported Event|Placebo (SAD)|SAD period
653105|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653106|NCT02202759|O3|Outcome|MLN0264 1.8 mg/kg (GCC High)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 8 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score >120). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653107|NCT02202759|O2|Outcome|MLN0264 1.8 mg/kg (GCC Intermediate)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 9 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Intermediate (combined H-score 60-119). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653108|NCT02202759|O1|Outcome|MLN0264 1.8 mg/kg (GCC Low)|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264. Participants with guanylyl cyclase C (GCC) protein expression=Low (combined H-score 10-59). Total H-score 0-600 is the combined score of cytoplasmic staining 0-300 and apical staining 0-300 and is based on the percentage of tumor cells with staining intensity 1+, 2+ and 3+.
653109|NCT02202759|E1|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, for up to 1 year or until disease progression or unacceptable toxicity occurs (Up to 14 cycles). The dose may be decreased, delayed or discontinued in participants who develop treatment-associated nonhematologic and hematologic toxicity to MLN0264.
653110|NCT02202538|B1|Baseline|All Subjects|All subjects enrolled in the study used the Indego
653111|NCT02202538|P1|Participant Flow|All Subjects|All subjects enrolled in the study used the Indego
653112|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653113|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653114|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653115|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653116|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653117|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653118|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653119|NCT02202538|O1|Outcome|All Enrolled Subjects Who Completed the Study|All subjects in the study used the Indego
653120|NCT02202538|E1|Reported Event|All Subjects|All subjects enrolled in the study used the Indego
653121|NCT02202252|B3|Baseline|Total|Total of all reporting groups
653122|NCT02202252|B2|Baseline|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653123|NCT02202252|B1|Baseline|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653124|NCT02202252|P2|Participant Flow|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653125|NCT02202252|P1|Participant Flow|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653175|NCT02201940|E1|Reported Event|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653176|NCT02201901|B4|Baseline|Total|Total of all reporting groups
653177|NCT02201901|B3|Baseline|SOF/VEL 24 Weeks ((Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653178|NCT02201901|B2|Baseline|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + Ribavirin (RBV) tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653126|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653127|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653128|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653129|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653130|NCT02202252|O2|Outcome|Double Drain|"Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of double drains: Two drains will be inserted into the axilla and below the lower flap in the double drains group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653131|NCT02202252|O1|Outcome|Single Drain|"Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.~Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla.~Ultrasonography after removal of the drains: One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography."
653132|NCT02202252|E2|Reported Event|Double Drain|Insertion of double drains: Two negative pressure drains will be inserted into the axilla and below the lower flap in the double drains group.
653133|NCT02202252|E1|Reported Event|Single Drain|Insertion of a single drain: A negative pressure drain will be inserted below the lower flap directing to the axilla in the single drain group.
653134|NCT02202135|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
653135|NCT02202135|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
653136|NCT02202135|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
653137|NCT02202135|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg 120 min
653138|NCT02201953|B3|Baseline|Total|Total of all reporting groups
653139|NCT02201953|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653140|NCT02201953|B1|Baseline|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653141|NCT02201953|P2|Participant Flow|SOF+RBV 24 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653142|NCT02201953|P1|Participant Flow|SOF/VEL 12 Weeks|Sofosbuvir/velpatasvir (SOF/VEL) (400/100 mg) fixed-dose combination (FDC) tablet administered orally once daily for 12 weeks
653143|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653144|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653145|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653146|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653147|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653148|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653149|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653150|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653151|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653152|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653153|NCT02201953|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) administered orally for 24 weeks
653154|NCT02201953|O1|Outcome|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653155|NCT02201953|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
653156|NCT02201953|E1|Reported Event|SOF/VEL 12 Weeks|SOF/VEL (400/100 mg) FDC tablet administered orally once daily for 12 weeks
653157|NCT02201940|B3|Baseline|Total|Total of all reporting groups
653185|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653186|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653187|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653188|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653189|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653190|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653191|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653192|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653193|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653194|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653195|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653196|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653197|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653198|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653199|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653200|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653201|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653202|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653203|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653204|NCT02201901|O3|Outcome|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653205|NCT02201901|O2|Outcome|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653206|NCT02201901|O1|Outcome|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653207|NCT02201901|E3|Reported Event|SOF/VEL 24 Weeks (Group 3)|SOF/VEL (400/100 mg) FDC tablet once daily for 24 weeks
653208|NCT02201901|E2|Reported Event|SOF/VEL+RBV 12 Weeks (Group 2)|SOF/VEL (400/100 mg) FDC tablet + RBV tablets (1000 or 1200 mg/day divided twice daily) administered orally once daily for 12 weeks
653209|NCT02201901|E1|Reported Event|SOF/VEL 12 Weeks (Group 1)|SOF/VEL (400/100 mg) FDC tablet once daily for 12 weeks
653210|NCT02201784|B3|Baseline|Total|Total of all reporting groups
653211|NCT02201784|B2|Baseline|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653212|NCT02201784|B1|Baseline|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653213|NCT02201784|P2|Participant Flow|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653214|NCT02201784|P1|Participant Flow|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653215|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653216|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653217|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653218|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653219|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653220|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653221|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653222|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653223|NCT02201784|O2|Outcome|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653224|NCT02201784|O1|Outcome|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653225|NCT02201784|E2|Reported Event|Ropivacaine 0.75%|"intrathecal administration of 22.5 mg of Ropivacaine 0.75%~Ropivacaine: Comparison of equipotent doses"
653226|NCT02201784|E1|Reported Event|Levobupivacaine 0.5%|"intrathecal administration of 15 mg of Levobupivacaine 0.5%~Levobupivacaine: Comparison of Equipotent doses"
653227|NCT02201524|B5|Baseline|Total|Total of all reporting groups
653228|NCT02201524|B4|Baseline|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653229|NCT02201524|B3|Baseline|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653230|NCT02201524|B2|Baseline|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653231|NCT02201524|B1|Baseline|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653232|NCT02201524|P4|Participant Flow|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653233|NCT02201524|P3|Participant Flow|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653234|NCT02201524|P2|Participant Flow|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653235|NCT02201524|P1|Participant Flow|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653236|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653237|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653238|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653239|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653240|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653241|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653242|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653243|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653244|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653245|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653246|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653247|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653248|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653249|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653250|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653251|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653252|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653253|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653254|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653255|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653256|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653257|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653258|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653259|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653260|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653261|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653262|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653263|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653264|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653265|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653266|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653267|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653268|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653269|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653270|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653271|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653272|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653273|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653274|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
658636|NCT02147288|P6|Participant Flow|Lipoabdominoplasty on JP Drains|
653275|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653276|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653277|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653278|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653279|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653280|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653281|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653282|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653283|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653284|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653285|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653286|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653287|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653288|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653289|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653290|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653291|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653292|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653293|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653294|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653295|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653296|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653297|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653298|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653299|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653300|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653301|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653302|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653303|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653304|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653305|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653306|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653307|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653308|NCT02201524|O4|Outcome|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653309|NCT02201524|O3|Outcome|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653310|NCT02201524|O2|Outcome|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653311|NCT02201524|O1|Outcome|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653312|NCT02201524|E4|Reported Event|PF-04965842 200 mg Twice Daily|Participants received PF-04965842 200 mg tablets, orally twice daily from Day 1 to 28.
653313|NCT02201524|E3|Reported Event|PF-04965842 400 mg Once Daily|Participants received PF-04965842 400 mg tablets, orally once daily from Days 1 to 28.
653314|NCT02201524|E2|Reported Event|PF-04965842 200 Milligram (mg) Once Daily|Participants received PF-04965842 200 mg tablets, orally once daily from Day 1 to 28.
653315|NCT02201524|E1|Reported Event|Placebo|Participants received placebo matched to PF-04965842 tablets orally from Day 1 to 28.
653316|NCT02201446|B3|Baseline|Total|Total of all reporting groups
653317|NCT02201446|B2|Baseline|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653318|NCT02201446|B1|Baseline|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653383|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653319|NCT02201446|P2|Participant Flow|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653391|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
653392|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653320|NCT02201446|P1|Participant Flow|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653321|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653322|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653323|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653324|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653325|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653326|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653327|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653328|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653329|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653330|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653331|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653332|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653333|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653334|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653335|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653336|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653337|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653338|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653339|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653384|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653385|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653386|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653393|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653394|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653340|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653341|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653342|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653343|NCT02201446|O2|Outcome|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653344|NCT02201446|O1|Outcome|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014–2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653345|NCT02201446|E2|Reported Event|Healthy Volunteers|Fifty-eight healthy volunteers recruited from the general population who had no significant medical history and no medications were categorized as control patients.
653346|NCT02201446|E1|Reported Event|ARDS Patients|Eighty-one patients were enrolled consecutively over a two-year time period (2014-2015) and identified as ARDS prospectively according to the Berlin definitions of the European Society of Intensive Care Medicine and American Thoracic Society on ARDS. Exclusion criteria were an age of less than 16 years, pregnancy, chronic obstructive pulmonary disease according to medical history and failure to obtain informed consent.
653347|NCT02201420|B1|Baseline|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
653348|NCT02201420|P1|Participant Flow|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
653349|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
653350|NCT02201420|O1|Outcome|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
653351|NCT02201420|E1|Reported Event|Tc 99m Tilmanocept|"Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging.~Tc 99m tilmanocept"
653352|NCT02201056|B8|Baseline|Total|Total of all reporting groups
653353|NCT02201056|B7|Baseline|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653354|NCT02201056|B6|Baseline|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653355|NCT02201056|B5|Baseline|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653356|NCT02201056|B4|Baseline|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
653357|NCT02201056|B3|Baseline|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653358|NCT02201056|B2|Baseline|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653359|NCT02201056|B1|Baseline|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
653360|NCT02201056|P7|Participant Flow|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653361|NCT02201056|P6|Participant Flow|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653362|NCT02201056|P5|Participant Flow|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653363|NCT02201056|P4|Participant Flow|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
653364|NCT02201056|P3|Participant Flow|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653365|NCT02201056|P2|Participant Flow|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653366|NCT02201056|P1|Participant Flow|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
653367|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653368|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653369|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653370|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
653371|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653372|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653373|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653374|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653375|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653376|NCT02201056|O3|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
653377|NCT02201056|O2|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653378|NCT02201056|O1|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653379|NCT02201056|O6|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653380|NCT02201056|O5|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653381|NCT02201056|O4|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
658637|NCT02147288|P5|Participant Flow|Lipoabdominoplasty on NPWT|
653398|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
653399|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653400|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653401|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653402|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
653403|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653404|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653405|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
653406|NCT02201056|O7|Outcome|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653407|NCT02201056|O6|Outcome|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653408|NCT02201056|O5|Outcome|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653409|NCT02201056|O4|Outcome|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
653410|NCT02201056|O3|Outcome|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653411|NCT02201056|O2|Outcome|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653412|NCT02201056|O1|Outcome|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
653413|NCT02201056|E7|Reported Event|Cohort 6: TAK-935 1350 mg|TAK-935 1350 mg solution, orally, once, on Day 1.
653414|NCT02201056|E6|Reported Event|Cohort 5: TAK-935 900 mg|TAK-935 900 mg solution, orally, once, on Day 1.
653415|NCT02201056|E5|Reported Event|Cohort 4: TAK-935 600 mg|TAK-935 600 mg solution, orally, once, on Day 1.
653416|NCT02201056|E4|Reported Event|Cohort 3: TAK-935 200 mg|TAK-935 200 mg solution, orally, once, on Day 1.
653417|NCT02201056|E3|Reported Event|Cohort 2: TAK-935 50 mg|TAK-935 50 mg solution, orally, once, on Day 1.
653418|NCT02201056|E2|Reported Event|Cohort 1: TAK-935 15 mg|TAK-935 15 mg solution, orally, once, on Day 1.
653419|NCT02201056|E1|Reported Event|Cohorts 1-6: Placebo|TAK-935 placebo-matching solution, orally, once, on Day 1.
653420|NCT02200536|B4|Baseline|Total|Total of all reporting groups
653421|NCT02200536|B3|Baseline|Control 2|No intervention.
653422|NCT02200536|B2|Baseline|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
653423|NCT02200536|B1|Baseline|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
653424|NCT02200536|P3|Participant Flow|Control 2|No intervention.
653425|NCT02200536|P2|Participant Flow|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
653426|NCT02200536|P1|Participant Flow|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
653427|NCT02200536|O3|Outcome|Control 2|No intervention.
653428|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
653429|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
653430|NCT02200536|O3|Outcome|Control 2|No intervention.
653431|NCT02200536|O2|Outcome|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
653432|NCT02200536|O1|Outcome|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
653433|NCT02200536|E3|Reported Event|Control 2|No intervention.
653434|NCT02200536|E2|Reported Event|Control 1|"Infant oral health pamphlet~Infant oral health pamphlet: Infant oral health pamphlet"
653435|NCT02200536|E1|Reported Event|Test|"Infant oral health promotion package~Infant oral health promotion package: Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup."
653436|NCT02200458|B1|Baseline|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
653437|NCT02200458|P1|Participant Flow|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
653438|NCT02200458|O1|Outcome|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
653439|NCT02200458|E1|Reported Event|VeinViewer|"Vascular imaging technology will be used to visualize peripheral vasculature.~VeinViewer"
653440|NCT02200328|B3|Baseline|Total|Total of all reporting groups
653441|NCT02200328|B2|Baseline|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
653442|NCT02200328|B1|Baseline|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
653443|NCT02200328|P2|Participant Flow|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
653444|NCT02200328|P1|Participant Flow|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
653445|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
653446|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
653729|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653447|NCT02200328|O2|Outcome|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
653448|NCT02200328|O1|Outcome|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
653449|NCT02200328|E2|Reported Event|Placebo|"Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days~Placebo: Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days"
653450|NCT02200328|E1|Reported Event|Metronidazole|"Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days~Metronidazole: Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days"
653451|NCT02199717|B1|Baseline|Boys With Hemophilia|
653452|NCT02199717|P1|Participant Flow|Boys With Hemophilia|Use of accelerometer for 1 week
653453|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
653454|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
653455|NCT02199717|O2|Outcome|Mild/Moderate Hemophilia|Mild/Moderate Hemophilia
653456|NCT02199717|O1|Outcome|Severe Hemophilia|Severe Hemophilia
653457|NCT02199717|E1|Reported Event|Severe Hemophilia|
653458|NCT02199574|B1|Baseline|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
653459|NCT02199574|P1|Participant Flow|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
653460|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
653461|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
653462|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
653463|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
653464|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: Protocol was amended after a single subject received a dose of 266 mg EXPAREL to a dose level of 133 mg EXPAREL."
653465|NCT02199574|O1|Outcome|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL: 133 mg EXPAREL in 10 mL."
653466|NCT02199574|E1|Reported Event|EXPAREL|"Single administration of EXPAREL 133 mg (10 mL).~EXPAREL"
653467|NCT02198963|B1|Baseline|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
653468|NCT02198963|P1|Participant Flow|RUT058-60 vs Negative Control vs Positive Control|Each subject was their own control and received occlusive patches containing approximately 200 mg of all three (test article, negative control, and positive control) applied to abraded and non abraded skin sites in the scapular region of each subject's back.
653469|NCT02198963|O6|Outcome|Physiological Saline (0.9%), USP- Non-Abraded|0.02 mL of the Negative Control applied to non-abraded skin sites.
653470|NCT02198963|O5|Outcome|Sodium Lauryl Sulfate (0.1%)- Non-Abraded|0.02 mL of the Positive Control applied to non-abraded skin sites.
653471|NCT02198963|O4|Outcome|Hypochlorous Acid Solution 106 mg/L- Non-Abraded|0.02 mL of the Test Product RUT058-60 applied to non-abraded skin sites.
653472|NCT02198963|O3|Outcome|Physiological Saline (0.9%), USP-Abraded|0.02 mL of the Negative Control applied to abraded skin sites.
653473|NCT02198963|O2|Outcome|Sodium Lauryl Sulfate (0.1%) -Abraded|0.02 mL of the Positive Control applied to abraded skin sites.
653474|NCT02198963|O1|Outcome|Hypochlorous Acid Solution 106 mg/L-Abraded|0.02 mL of the Test Product RUT058-60 applied to abraded skin sites.
653475|NCT02198963|E1|Reported Event|RUT058-60 vs Negative and Positve Controls|All subjects who were enrolled, remained compliant and participated in all scheduled visits and received all study material applications were analyzed.
653476|NCT02198833|B3|Baseline|Total|Total of all reporting groups
653477|NCT02198833|B2|Baseline|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653478|NCT02198833|B1|Baseline|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653479|NCT02198833|P2|Participant Flow|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653501|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
653480|NCT02198833|P1|Participant Flow|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653507|NCT02198235|B3|Baseline|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653481|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653482|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653483|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653484|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653485|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653486|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653487|NCT02198833|O2|Outcome|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653488|NCT02198833|O1|Outcome|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653489|NCT02198833|E2|Reported Event|Standard-of-Care Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653490|NCT02198833|E1|Reported Event|Micro-Patterned Foley Catheter|"Procedures: Foley Catheter Insertion, Device Specific Adverse Event Assessment, Urine Cultures, Foley Catheter Tip Culture, Scanning Electron Microscopy~Urine Culture: Obtain urine culture every third day~Foley Catheter Tip Culture: Catheter Tip Roll Plate Culture~Scanning Electron Microscopy: Houston Site Only~Device Specific Adverse Event Assessment: Assessment will be made of catheter patency and/or trauma related to catheter placement~Foley Catheter Insertion: Insert Foley catheter for 15 day duration"
653491|NCT02198430|B3|Baseline|Total|Total of all reporting groups
653492|NCT02198430|B2|Baseline|Control Group|Children without hemophilia
653493|NCT02198430|B1|Baseline|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
653494|NCT02198430|P2|Participant Flow|Control Group|Children without hemophilia
653495|NCT02198430|P1|Participant Flow|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
653496|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
653497|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
653498|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
653499|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
653500|NCT02198430|O2|Outcome|Control Group|Children without hemophilia
653503|NCT02198430|O1|Outcome|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
653504|NCT02198430|E2|Reported Event|Control Group|Children without hemophilia
653505|NCT02198430|E1|Reported Event|Patients|Patients with haemophilia recruited for multidisciplinary assessment of the main physical, functional and psychosocial variables.
653506|NCT02198235|B4|Baseline|Total|Total of all reporting groups
653508|NCT02198235|B2|Baseline|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653509|NCT02198235|B1|Baseline|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
653510|NCT02198235|P3|Participant Flow|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653511|NCT02198235|P2|Participant Flow|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653512|NCT02198235|P1|Participant Flow|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
653513|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653514|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653515|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
653516|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653517|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653518|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
653519|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653520|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653521|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
653522|NCT02198235|O3|Outcome|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653523|NCT02198235|O2|Outcome|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653524|NCT02198235|O1|Outcome|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
653525|NCT02198235|E3|Reported Event|Nerve Block With Dexamethasone + Buprenorphine in Block.|"Dexamethasone (4 mg) Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653526|NCT02198235|E2|Reported Event|Control Nerve Block + IV Dexamethasone + IV Buprenorphine|"IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)~Dexamethasone~Buprenorphine"
653527|NCT02198235|E1|Reported Event|Control Nerve Block + IV Dexamethasone|"IV Dexamethasone (4 mg)~Dexamethasone"
653528|NCT02198040|B4|Baseline|Total|Total of all reporting groups
653529|NCT02198040|B3|Baseline|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653530|NCT02198040|B2|Baseline|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653531|NCT02198040|B1|Baseline|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each.~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653532|NCT02198040|P3|Participant Flow|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653533|NCT02198040|P2|Participant Flow|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653556|NCT02198040|E3|Reported Event|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653582|NCT02197273|B2|Baseline|Liposomal Bupivacaine|"THA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
653730|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653534|NCT02198040|P1|Participant Flow|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist, to adduction, internal rotation of shoulder with flexion of elbow and palmar flexion of wrist and fingers.~10"
653535|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653536|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653537|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653538|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653539|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653540|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653541|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653542|NCT02198040|O2|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653543|NCT02198040|O1|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder with extension of elbow and dorsal flexion of wrist.~10"
653544|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653611|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653720|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653721|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653545|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653546|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653547|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653548|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653549|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653550|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653551|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653552|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653553|NCT02198040|O3|Outcome|Control Group|The control group did not receive any intervention. The patients in this group were assessed by the same reviewers (blinded to the study conditions) and under the same conditions, that patients in the experimental groups.
653554|NCT02198040|O2|Outcome|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653555|NCT02198040|O1|Outcome|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653557|NCT02198040|E2|Reported Event|Manual Therapy Group|"The treatment of this group consisted of two sessions per week, one hour each. We used joint traction, passive muscles stretching and Proprioceptive Neuromuscular Facilitation~Manual Therapy: - 5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.~15 minutes. Passive muscle stretching (within the limits of mobility). Compression technique, passive muscle stretching and relaxation in biceps and triceps.~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb.~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
653558|NCT02198040|E1|Reported Event|Educational Gruop|"The treatment had education and home daily exercises for the improvement of the range of motion, biceps strength, perimeter of arm and the perception of pain in patients with haemophilia and arthropathy of the elbow.~Educational group: - Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.~- Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
653559|NCT02197806|B5|Baseline|Total|Total of all reporting groups
653560|NCT02197806|B4|Baseline|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
653561|NCT02197806|B3|Baseline|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653562|NCT02197806|B2|Baseline|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653563|NCT02197806|B1|Baseline|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653564|NCT02197806|P4|Participant Flow|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
653565|NCT02197806|P3|Participant Flow|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653566|NCT02197806|P2|Participant Flow|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653567|NCT02197806|P1|Participant Flow|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653568|NCT02197806|O4|Outcome|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
653569|NCT02197806|O3|Outcome|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653570|NCT02197806|O2|Outcome|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653571|NCT02197806|O1|Outcome|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653572|NCT02197806|E4|Reported Event|AGN-199201 + AGN-190584 in Both Eyes|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in both eyes, once and twice daily for 3 days each.
653573|NCT02197806|E3|Reported Event|AGN-199201 + AGN-190584 in One Eye|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-190584 ophthalmic solution in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653574|NCT02197806|E2|Reported Event|AGN-190584|1 drop of AGN-190584 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653575|NCT02197806|E1|Reported Event|AGN-199201|1 drop of AGN-199201 ophthalmic solution followed by 1 drop of AGN-199201 vehicle in the non-dominant eye and 2 drops of AGN-199201 vehicle in the dominant eye, once and twice daily for 3 days each.
653576|NCT02197455|B1|Baseline|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
653577|NCT02197455|P1|Participant Flow|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
653578|NCT02197455|O1|Outcome|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
653579|NCT02197455|O1|Outcome|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
653580|NCT02197455|E1|Reported Event|Tofacitinib Administration|"5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.~Tofacitinib Administration: 5 mg of Tofacitinib will be taken by mouth twice daily for 3 months."
653581|NCT02197273|B3|Baseline|Total|Total of all reporting groups
653633|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653583|NCT02197273|B1|Baseline|Standard of Care Analgesia|"THA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
653584|NCT02197273|P2|Participant Flow|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
653585|NCT02197273|P1|Participant Flow|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
653586|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
653587|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
653588|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
653589|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
653590|NCT02197273|O2|Outcome|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
653591|NCT02197273|O1|Outcome|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
653710|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653711|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653592|NCT02197273|E2|Reported Event|Liposomal Bupivacaine|"THA:~36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue~TKA:~33 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.~Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue~TSA:~34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.~Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle~Liposomal bupivacaine~Standard of care analgesia"
653593|NCT02197273|E1|Reported Event|Standard of Care Analgesia|"THA:~33 patients received a spinal anesthetic using Fentanyl and Bupivacaine~Injection into capsular tissue after placement of the acetabular component:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TKA:~39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc~Injection into posterior capsule of the knee:~0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline~TSA:~35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.~Standard of care analgesia"
653594|NCT02197247|B1|Baseline|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
653595|NCT02197247|P1|Participant Flow|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
653596|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653597|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653598|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653599|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653600|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653601|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653602|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653603|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653604|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653605|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653606|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653607|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653608|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653609|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653610|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653712|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653713|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653612|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653613|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653731|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653614|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653615|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653616|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653617|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653618|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653619|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653620|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653621|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653622|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653623|NCT02197247|O1|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653624|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653625|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653626|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653627|NCT02197247|O3|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653628|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653629|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653630|NCT02197247|O2|Outcome|AZD9291 Alone (Period 3)|AZD9291 80 mg once daily on Days 50 to 77 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 77.
653631|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653632|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653714|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653715|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653634|NCT02197247|O2|Outcome|AZD9291 + Rifampicin (Period 2)|Concomitant treatment with AZD9291 80 mg once daily and rifampicin 600 mg once daily on Days 29 to 49 (Part A). All treatments (AZD9291 and rifampicin) were administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 49.
653635|NCT02197247|O1|Outcome|AZD9291 Alone (Period 1)|AZD9291 80 mg once daily on Days 1 to 28 (Part A). AZD9291 was administered fasted from at least 2 hours before dosing to at least 2 hours after dosing. Water was allowed as desired except for 1 hour before and after AZD9291 administration on Day 28.
653636|NCT02197247|E1|Reported Event|AZD9291 Alone, AZD9291 + Rifampicin, AZD9291 Alone|Sequential treatments of AZD9291 alone (Period 1), followed by AZD9291 + rifampicin (Period 2), followed by AZD9291 alone (Period 3) (Part A).
653637|NCT02197234|B1|Baseline|AZD9291 and Simvastatin|Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291.
653638|NCT02197234|P1|Participant Flow|AZD9291 and Simvastatin|Sequential treatments of simvastatin alone followed by AZD9291 alone, followed by simvastatin + AZD9291.
653639|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
653640|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
653641|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
653642|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
653643|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
653644|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
653645|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
653646|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
653647|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
653648|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
653649|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
653650|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
653651|NCT02197234|O2|Outcome|AZD9291 + Simvastatin|AZD9291 80 mg once daily on Days 3 to 32; Simvastatin 40 mg on Day 31.
653652|NCT02197234|O1|Outcome|Simvastatin Alone|Simvastatin (CYP substrate) 40mg taken as single dose on Day 1.
653653|NCT02197234|E4|Reported Event|Overall|Simvastatin 40mg on Days 1 and 31. Daily AZD9291 doses on Days 3-32
653654|NCT02197234|E3|Reported Event|Simvastatin + AZD9291|Single oral dose of simvastatin 40mg on Day 31 and single oral doses of AZD9291 on Day 31 and 32
653655|NCT02197234|E2|Reported Event|AZD9291|AZD9291 80mg daily dosing on Days 3-30.
653656|NCT02197234|E1|Reported Event|Simvastatin Alone|Simvastatin 40mg single oral dose on Day 1
653657|NCT02196766|B1|Baseline|Bioclean First Care EX / Aosept Clearcare / Comfil|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
653658|NCT02196766|P2|Participant Flow|Aosept Clearcare Combo First,Then Bioclean First Care EX Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
653659|NCT02196766|P1|Participant Flow|Bioclean First Care EX Combo, Then Aosept Clearcare Combo|Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.
653660|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653661|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653662|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653663|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653664|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653665|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653716|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653717|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653718|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653666|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653726|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653727|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653728|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653667|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653668|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653669|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653670|NCT02196766|O2|Outcome|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Aosept Clearcare / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653671|NCT02196766|O1|Outcome|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653672|NCT02196766|E2|Reported Event|Aosept Clearcare / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653673|NCT02196766|E1|Reported Event|Bioclean First Care EX / Comfilcon A|"Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination.~Bioclean First Care EX / comfilcon A: Subjects dispensed either Bioclean First Care EX / comfilcon A combination or Aosept Clearcare / comfilcon A combination and then crossover to the alternate combination."
653674|NCT02196714|B1|Baseline|All Subjects|Analysis Set: All Subjects Randomized
653675|NCT02196714|P4|Participant Flow|Received GP MDI 14.4 μg|Received GP MDI 14.4 μg
653676|NCT02196714|P3|Participant Flow|Received GP MDI 28.8 μg|Glycopyrronium (GP) Metered Dose Inhaler (MDI) 28.8 μg
653677|NCT02196714|P2|Participant Flow|Received GFF MDI 14.4/9.6 μg|Received GFF MDI 14.4/9.6 μg
653678|NCT02196714|P1|Participant Flow|Received GFF MDI 28.8/9.6 μg|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 μg
653679|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653680|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653681|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653682|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653683|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653684|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653685|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653686|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653687|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653688|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653689|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653690|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653691|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653692|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653693|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653694|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653695|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653696|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653697|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653698|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653699|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653700|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653701|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653702|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653703|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653704|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653705|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653706|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653707|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653708|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653709|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653723|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653724|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653725|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
654822|NCT02185105|O2|Outcome|Comfilcon A Toric|
653732|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653733|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653734|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653735|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653736|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653737|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653738|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653739|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653740|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653741|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
653742|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653743|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653744|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653745|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653746|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653747|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
653748|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
653749|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653750|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653751|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653752|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653753|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
653754|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
653755|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653756|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653757|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653758|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653759|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
653760|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653761|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653762|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653763|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653764|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653765|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
653766|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653767|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653768|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653769|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653770|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653771|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
653772|NCT02196714|O3|Outcome|GP MDI 28.8 µg|GP MDI 28.8 µg
653773|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653774|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653775|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653776|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653777|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
653778|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653779|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653780|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653781|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653782|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653783|NCT02196714|O4|Outcome|GP MDI 14.4 ug|GP MDI 14.4 ug
653784|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653785|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653786|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653787|NCT02196714|O2|Outcome|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653788|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653789|NCT02196714|O4|Outcome|GP MDI 14.4 µg|GP MDI 14.4 µg
653790|NCT02196714|O3|Outcome|GP MDI 28.8 ug|GP MDI 28.8 ug
653792|NCT02196714|O1|Outcome|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653793|NCT02196714|E4|Reported Event|GP MDI 14.4 µg|GP MDI 14.4 µg
653794|NCT02196714|E3|Reported Event|GP MDI 28.8 ug|GP MDI 28.8 ug
653795|NCT02196714|E2|Reported Event|GFF MDI 14.4/9.6 ug|GFF MDI 14.4/9.6 ug
653796|NCT02196714|E1|Reported Event|GFF MDI 28.8/9.6 ug|Glycopyrronium and Formoterol Fumurate (GFF) Metered Dose Inhaler (MDI) 28.8/9.6 ug
653797|NCT02196675|B4|Baseline|Total|Total of all reporting groups
653798|NCT02196675|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
653799|NCT02196675|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
653800|NCT02196675|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
653801|NCT02196675|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
653802|NCT02196675|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy using Echelon FlexTM Powered ENDOPATH® Stapler
653803|NCT02196675|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection using Echelon FlexTM Powered ENDOPATH® Stapler
653804|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
653805|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
653806|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
653807|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
653808|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
653809|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
653810|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
653811|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
653812|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
653813|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
653814|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
653815|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
653816|NCT02196675|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
653817|NCT02196675|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
653818|NCT02196675|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
653819|NCT02196675|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
653820|NCT02196675|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
653821|NCT02196675|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
653822|NCT02196259|B4|Baseline|Total|Total of all reporting groups
653823|NCT02196259|B3|Baseline|Depression|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
653824|NCT02196259|B2|Baseline|Initial Hospital|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
653825|NCT02196259|B1|Baseline|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
653826|NCT02196259|P3|Participant Flow|Depresssion|
653827|NCT02196259|P2|Participant Flow|Hospital|
653828|NCT02196259|P1|Participant Flow|Initial MRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
653829|NCT02196259|O2|Outcome|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
653830|NCT02196259|O1|Outcome|Initial MRI|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
653831|NCT02196259|E3|Reported Event|Depression|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
653854|NCT02196168|E1|Reported Event|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653832|NCT02196259|E2|Reported Event|Hospital|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
653905|NCT02195713|P2|Participant Flow|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
654061|NCT02193828|E4|Reported Event|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654823|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
653833|NCT02196259|E1|Reported Event|Initial fMRI|"The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)~Anesthetics, Dissociative: The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)"
653834|NCT02196168|B3|Baseline|Total|Total of all reporting groups
653835|NCT02196168|B2|Baseline|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653836|NCT02196168|B1|Baseline|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653837|NCT02196168|P2|Participant Flow|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653838|NCT02196168|P1|Participant Flow|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653839|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653840|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653841|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653842|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653843|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653844|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653845|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653846|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653847|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653848|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653849|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653850|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653851|NCT02196168|O2|Outcome|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653852|NCT02196168|O1|Outcome|Arm I (WEE1 Inhibitor MK-1775, Cisplatin)|"Patients receive WEE1 inhibitor MK-1775 PO BID for 5 doses beginning on day 1 and cisplatin IV over 1 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~WEE1 Inhibitor AZD1775: Given PO"
653853|NCT02196168|E2|Reported Event|Arm II (Placebo, Cisplatin)|"Patients receive placebo PO BID for 5 doses beginning on day 1 and cisplatin IV over 2 hour on day 1.~Cisplatin: Given IV~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
653855|NCT02196077|B1|Baseline|Subjects|
653856|NCT02196077|P1|Participant Flow|Subjects|
653857|NCT02196077|O5|Outcome|FF MDI 9.6 ug|FF MDI 9.6 ug
653903|NCT02195713|B2|Baseline|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
653904|NCT02195713|B1|Baseline|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
653906|NCT02195713|P1|Participant Flow|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
653907|NCT02195713|O2|Outcome|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
653908|NCT02195713|O1|Outcome|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
653909|NCT02195713|E2|Reported Event|Control- Critcore Urine Output Monitor|A commercially available urine output monitor (Criticore, Bard Medical) was attached to the Foley catheter and urine output / drainage line pressure was monitored.
653910|NCT02195713|E1|Reported Event|Test- Accuryn Urine Output Monitor|"Accuryn Anti-airlock Drainage System was attached to the Foley catheter and urine output / drainage line pressure was monitored.~Accuryn: Accuryn is a novel electronic urine output monitor"
653911|NCT02195687|B3|Baseline|Total|Total of all reporting groups
653912|NCT02195687|B2|Baseline|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653913|NCT02195687|B1|Baseline|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653914|NCT02195687|P2|Participant Flow|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653915|NCT02195687|P1|Participant Flow|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653916|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653917|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653918|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653919|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653920|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653921|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653922|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653923|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653924|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653925|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653926|NCT02195687|O2|Outcome|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653927|NCT02195687|O1|Outcome|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653928|NCT02195687|E2|Reported Event|Placebo|Placebo (Normal Saline) injected into bilateral Crow's Feet Line areas on Day 1.
653929|NCT02195687|E1|Reported Event|Botulinum Toxin Type A|24U botulinum toxin Type A (BOTOX®) total dose injected into bilateral Crow's Feet Line areas on Day 1.
653930|NCT02195583|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
653931|NCT02195583|P1|Participant Flow|Overall Participants|"Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 seconds (sec) to create dentifrice slurry. Then swished the slurry around the palatal appliance for 1 minute (min) and 35 sec. Next, they expectorated the slurry, rinsed with 15 milliliter (mL) of tap water for 10 sec and expectorated. There was a 2 day washout period before each treatment period when participants used a non-fluoridated dentifrice.~Sodium fluoride (1426 ppm):Non-zinc, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1150 ppm):Non-zinc, 1150ppm fluoride as sodium fluoride in silica base~Sodium fluoride (250 ppm):Non-zinc, 250ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base A:Zinc base A, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (1426 ppm) + zinc base B:Zinc base B, 1426ppm fluoride as sodium fluoride in silica base~Sodium fluoride (0 ppm):Non-zinc, 0ppm fluoride in silica base"
653932|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Sodium fluoride (0 ppm) Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653933|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
654054|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
664332|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
653934|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
654059|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
653935|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653936|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653937|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653938|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653939|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653940|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653941|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653942|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653943|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653944|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653945|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653981|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
654055|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
669371|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
653946|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653947|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653948|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653949|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653950|NCT02195583|O6|Outcome|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653951|NCT02195583|O5|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653952|NCT02195583|O4|Outcome|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653953|NCT02195583|O3|Outcome|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653954|NCT02195583|O2|Outcome|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653955|NCT02195583|O1|Outcome|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653956|NCT02195583|E6|Reported Event|Sodium Fluoride (0 Ppm)|Non-zinc, 0ppm fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653957|NCT02195583|E5|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653982|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
654056|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
669372|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
653958|NCT02195583|E4|Reported Event|Sodium Fluoride (1426 Ppm) + Zinc Base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653959|NCT02195583|E3|Reported Event|Sodium Fluoride (250 Ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653960|NCT02195583|E2|Reported Event|Sodium Fluoride (1150 Ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653961|NCT02195583|E1|Reported Event|Sodium Fluoride (1426 Ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica base. Participants brushed the buccal surface of their teeth with 1.5 g (± 0.1 g) dentifrice for 25 sec to create dentifrice slurry. Next, they swished the dentifrice slurry around the palatal appliance for 1 min and 35 sec. After that, participants expectorated the slurry, gently but thoroughly rinsed with 15 mL of tap water for 10 sec and expectorated again. There was a 2 day wash-out period before each treatment period when participants used a non-fluoridated dentifrice.
653962|NCT02195414|B1|Baseline|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
653963|NCT02195414|P1|Participant Flow|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
653964|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
653965|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
653966|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
653967|NCT02195414|O1|Outcome|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
653968|NCT02195414|E1|Reported Event|NeoVas BCS|Patients received the NeoVas sirolimus-eluting bioresorbable coronary scaffold system, which is a PLLA-based polymer scaffold and contains the antiproliferative drug sirolimus.
653969|NCT02194621|B4|Baseline|Total|Total of all reporting groups
653970|NCT02194621|B3|Baseline|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
653971|NCT02194621|B2|Baseline|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
653972|NCT02194621|B1|Baseline|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
653973|NCT02194621|P3|Participant Flow|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
653974|NCT02194621|P2|Participant Flow|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
653975|NCT02194621|P1|Participant Flow|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
653976|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
653977|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
653978|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
653979|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
653980|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
653983|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
653984|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
653985|NCT02194621|O3|Outcome|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
653986|NCT02194621|O2|Outcome|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
653987|NCT02194621|O1|Outcome|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
653988|NCT02194621|E3|Reported Event|Crest Toothpaste|"Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)~Placebo toothpaste: Crest Cavity Protection toothpaste: Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)"
653989|NCT02194621|E2|Reported Event|Total Flavor Option 2|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 2 ingredient. Total Flavor Option 2~Total Flavor option 2: Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2"
653990|NCT02194621|E1|Reported Event|Total Flavor Option 1|"Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient - Total Flavor Option 1~Total Flavor option 1: Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1"
653991|NCT02194088|B3|Baseline|Total|Total of all reporting groups
653992|NCT02194088|B2|Baseline|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
653993|NCT02194088|B1|Baseline|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
653994|NCT02194088|P2|Participant Flow|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
653995|NCT02194088|P1|Participant Flow|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
653996|NCT02194088|O2|Outcome|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
653997|NCT02194088|O1|Outcome|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
653998|NCT02194088|O2|Outcome|Placebo|
653999|NCT02194088|O1|Outcome|Pain Medication:Diclofenac an Atropine|
654000|NCT02194088|O2|Outcome|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
654001|NCT02194088|O1|Outcome|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
654002|NCT02194088|E2|Reported Event|Placebo|"Placebo capsules will be delivered in same number as the medication~Placebo: For each capsule of active medication, a capsule of placebo will be provided, identical looking."
654003|NCT02194088|E1|Reported Event|Pain Medication: Diclofenac and Atropine|"Diclofenac and Atropine combination drug Provided PO. This is a novel combination. Diclofenac 100mg + Atropine 1.2 mg in one single dose~Diclofenac and Atropine combination drug: Diclofenac will be associated with a small dose of atropine 1.2mg"
654004|NCT02194062|B4|Baseline|Total|Total of all reporting groups
654005|NCT02194062|B3|Baseline|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
654006|NCT02194062|B2|Baseline|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
654007|NCT02194062|B1|Baseline|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
654008|NCT02194062|P3|Participant Flow|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
654009|NCT02194062|P2|Participant Flow|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
654010|NCT02194062|P1|Participant Flow|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
654011|NCT02194062|O3|Outcome|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
654060|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654824|NCT02185105|O2|Outcome|Comfilcon A Toric|
654012|NCT02194062|O2|Outcome|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
654013|NCT02194062|O1|Outcome|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
654014|NCT02194062|O3|Outcome|Budesonide Head Forward|"Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.~Budesonide: (0.5 mg/2mL) to instill into each nostril in the head forward position two times per day"
654015|NCT02194062|O2|Outcome|Budesonide Respule in Head Upright|"Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day~Budesonide: (0.5 mg/2mL) to instill into each nostril in the upright position two times per day"
654016|NCT02194062|O1|Outcome|Fluticasone Nasal Spray|"Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)~fluticasone nasal spray: use 2-50 mcg sprays to each nostril two times per day"
654017|NCT02194062|E3|Reported Event|Budesonide Head Forward|budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.
654018|NCT02194062|E2|Reported Event|Budesonide Respule in Head Upright|Budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day
654019|NCT02194062|E1|Reported Event|Fluticasone Group|Fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)
654020|NCT02193828|B5|Baseline|Total|Total of all reporting groups
654021|NCT02193828|B4|Baseline|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654022|NCT02193828|B3|Baseline|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654023|NCT02193828|B2|Baseline|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654024|NCT02193828|B1|Baseline|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654025|NCT02193828|P4|Participant Flow|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654026|NCT02193828|P3|Participant Flow|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654027|NCT02193828|P2|Participant Flow|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654028|NCT02193828|P1|Participant Flow|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654029|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654030|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654031|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654032|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654033|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654034|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654035|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654036|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654037|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654038|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654039|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654040|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654041|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654042|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654043|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654044|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654045|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654046|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654047|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654048|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654049|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654050|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654051|NCT02193828|O2|Outcome|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654052|NCT02193828|O1|Outcome|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654053|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654986|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
654057|NCT02193828|O4|Outcome|Placebo|Placebo, single 0.25 mg, 0.40 mg, or 0.60 mg injection into the nodule
654058|NCT02193828|O3|Outcome|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654825|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
654062|NCT02193828|E3|Reported Event|AA4500 0.25 mg|Collagenase clostridium histolyticum (AA4500), single 0.25 mg injection into the nodule
654063|NCT02193828|E2|Reported Event|AA4500 0.40 mg|Collagenase clostridium histolyticum (AA4500), single 0.40 mg injection into the nodule
654064|NCT02193828|E1|Reported Event|AA4500 0.60 mg|Collagenase clostridium histolyticum (AA4500), single 0.60 mg injection into the nodule
654065|NCT02193815|B1|Baseline|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
654066|NCT02193815|P1|Participant Flow|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
654067|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
654068|NCT02193815|O1|Outcome|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
654069|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
654070|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
654071|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
654072|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
654073|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
654074|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
654075|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
654076|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
654077|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
654078|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
654079|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
654080|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
654081|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
654082|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
654083|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
654084|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
654085|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
654086|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
654087|NCT02193815|O6|Outcome|Daivonex Ointment|All participants who received calcipotriol ointment (50 micrograms per gram [mcg/g]) topically once daily for 11 days.
654088|NCT02193815|O5|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
654089|NCT02193815|O4|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
654090|NCT02193815|O3|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
654091|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient-free) topically once daily for 11 days.
654092|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
654093|NCT02193815|O2|Outcome|Tofacitinib Vehicle|All participants who received tofacitinib vehicle (active ingredient-free) topically once daily for 11 days.
654094|NCT02193815|O1|Outcome|Tofacitinib 2% Ointment|All participants who received tofacitinib 2% ointment topically once daily for 11 days.
654095|NCT02193815|O2|Outcome|Daivonex Solution|All participants who received calcipotriol solution (50 micrograms per milliliter [mcg/mL]) topically once daily for 11 days.
654096|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
654097|NCT02193815|O2|Outcome|PF-06263276 Vehicle|All participants who received PF-06263276 vehicle (active ingredient- free) topically once daily for 11 days.
654098|NCT02193815|O1|Outcome|PF-06263276 4% Solution|All participants who received PF-06263276 4% solution topically once daily for 11 days.
654208|NCT02193087|O5|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654826|NCT02185105|O2|Outcome|Comfilcon A Toric|
654099|NCT02193815|E1|Reported Event|All Participants|Participants received the following treatments topically to 6 selected treatment fields: 4% PF-06263276 and its corresponding vehicle, 2% tofacitinib and its corresponding vehicle, calcipotriol (Daivonex) solution, and Daivonex ointment. The fields were occluded and participants returned daily to the center for re-application during the 11-day treatment period.
654100|NCT02193178|B1|Baseline|Overall Baseline Characteristics|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
654101|NCT02193178|P1|Participant Flow|Overall Participants|Participants are habitual toric lens wearers and will be fitted with comfilcon A toric lenses.
654102|NCT02193178|O2|Outcome|2 Weeks|
654103|NCT02193178|O1|Outcome|Baseline|
654104|NCT02193178|O2|Outcome|2 Weeks|
654105|NCT02193178|O1|Outcome|Baseline|
654106|NCT02193178|O2|Outcome|2 Weeks|
654107|NCT02193178|O1|Outcome|Baseline|
654108|NCT02193178|O2|Outcome|2 Weeks|
654109|NCT02193178|O1|Outcome|Baseline|
654110|NCT02193178|O2|Outcome|2 Weeks|
654111|NCT02193178|O1|Outcome|Baseline|
654112|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
654113|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
654114|NCT02193178|O1|Outcome|Habitual Lenses|
654115|NCT02193178|O4|Outcome|Conjunctival Indentation (2 Weeks)|
654116|NCT02193178|O3|Outcome|Conjunctival Staining (2 Weeks)|
654117|NCT02193178|O2|Outcome|Conjunctival Indentation (Baseline)|
654118|NCT02193178|O1|Outcome|Conjunctival Staining (Baseline)|
654119|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
654120|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
654121|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
654122|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
654123|NCT02193178|O2|Outcome|Comfilcon A – 2 Weeks|
654124|NCT02193178|O1|Outcome|Comfilcon A – Baseline|
654125|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
654126|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
654127|NCT02193178|O1|Outcome|Habitual Lenses|
654128|NCT02193178|O3|Outcome|2 Weeks|
654129|NCT02193178|O2|Outcome|Baseline|
654130|NCT02193178|O1|Outcome|Habitual Lenses|
654131|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
654132|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
654133|NCT02193178|O1|Outcome|Habitual Lenses|
654134|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
654135|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
654136|NCT02193178|O1|Outcome|Habitual Lenses|
654137|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
654138|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
654139|NCT02193178|O1|Outcome|Habitual Lenses|
654140|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
654141|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
654142|NCT02193178|O1|Outcome|Habitual Lenses|
654143|NCT02193178|O3|Outcome|Comfilcon A – 2 Weeks|
654144|NCT02193178|O2|Outcome|Comfilcon A – Baseline|
654145|NCT02193178|O1|Outcome|Habitual Lenses|
654146|NCT02193178|E1|Reported Event|Comfilcon A Toric XR MTO|"Participants are habitual contact lens wearers and will be fitted with comfilcon A Toric XR MTO lenses.~comfilcon A Toric XR (MTO) contact lenses"
654147|NCT02193165|B4|Baseline|Total|Total of all reporting groups
654148|NCT02193165|B3|Baseline|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654149|NCT02193165|B2|Baseline|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654150|NCT02193165|B1|Baseline|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654151|NCT02193165|P3|Participant Flow|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654152|NCT02193165|P2|Participant Flow|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654153|NCT02193165|P1|Participant Flow|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654204|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654154|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654827|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
654155|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654156|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654157|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654158|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654159|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654160|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654161|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654162|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654163|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654164|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654165|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654166|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654167|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654168|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654169|NCT02193165|O3|Outcome|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654170|NCT02193165|O2|Outcome|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654205|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654206|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654171|NCT02193165|O1|Outcome|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654172|NCT02193165|E3|Reported Event|Regimen 3 - Control Group|"fluoride toothpaste + fluoride Mouthwash~fluoride toothpaste + fluoride Mouthwash: Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds."
654173|NCT02193165|E2|Reported Event|Regimen 2|"stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash~stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds."
654174|NCT02193165|E1|Reported Event|Regimen 1|"triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash~triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash: Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds."
654175|NCT02193087|B5|Baseline|Total|Total of all reporting groups
654176|NCT02193087|B4|Baseline|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654177|NCT02193087|B3|Baseline|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654178|NCT02193087|B2|Baseline|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654179|NCT02193087|B1|Baseline|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654180|NCT02193087|P4|Participant Flow|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654181|NCT02193087|P3|Participant Flow|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654182|NCT02193087|P2|Participant Flow|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654183|NCT02193087|P1|Participant Flow|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654184|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654185|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654186|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654187|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654188|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654189|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654190|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654191|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654192|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654193|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654194|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654195|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654196|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654197|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654198|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654199|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654200|NCT02193087|O4|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654201|NCT02193087|O3|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654202|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654203|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654207|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654828|NCT02185105|O2|Outcome|Comfilcon A Toric|
654209|NCT02193087|O4|Outcome|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654210|NCT02193087|O3|Outcome|Group A and Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
654211|NCT02193087|O2|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654212|NCT02193087|O1|Outcome|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654213|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654214|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654215|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654216|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
654217|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654218|NCT02193087|O1|Outcome|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654219|NCT02193087|O2|Outcome|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654220|NCT02193087|O1|Outcome|Group A + Group B Combined|"Group A: Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).~Group B: TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3)."
654221|NCT02193087|E4|Reported Event|Group D: TDV Lyophilized|TDV Lyophilized Formulation reconstituted with water, subcutaneous injection on Day 1 and Day 90 (Month 3).
654222|NCT02193087|E3|Reported Event|Group C: TDV Liquid|TDV Liquid Formulation 2, subcutaneous injection on Day 1 and Day 90 (Month 3).
654223|NCT02193087|E2|Reported Event|Group B: TDV Liquid|TDV Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1 and Day 90 (Month 3).
654224|NCT02193087|E1|Reported Event|Group A: TDV Liquid + Placebo|Takeda's Tetravalent Dengue Vaccine Candidate (TDV) Liquid Formulation 1, diluted 1:5 with vaccine diluent, subcutaneous injection on Day 1, and TDV Liquid Formulation placebo-matching solution, subcutaneous injection, once on Day 90 (Month 3).
654225|NCT02192879|B4|Baseline|Total|Total of all reporting groups
654226|NCT02192879|B3|Baseline|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654227|NCT02192879|B2|Baseline|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654228|NCT02192879|B1|Baseline|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654229|NCT02192879|P3|Participant Flow|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654230|NCT02192879|P2|Participant Flow|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654231|NCT02192879|P1|Participant Flow|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654987|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654232|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654289|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
654233|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654234|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654235|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654236|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654237|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654238|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654239|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654240|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654241|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654242|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654243|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654244|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654245|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654260|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654330|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
654829|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
654246|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654247|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654248|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654249|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654250|NCT02192879|O3|Outcome|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654251|NCT02192879|O2|Outcome|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654252|NCT02192879|O1|Outcome|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654253|NCT02192879|E3|Reported Event|Patient-Controlled Analgesia|Patient-Controlled Analgesia: Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
654254|NCT02192879|E2|Reported Event|Continuous Paravertebral Catheter|continuous paravertebral catheter: Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
654255|NCT02192879|E1|Reported Event|Thoracic Epidural|thoracic epidural: Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
654256|NCT02192814|B1|Baseline|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654257|NCT02192814|P1|Participant Flow|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654258|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654259|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654288|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
654261|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654262|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654263|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654264|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654265|NCT02192814|O1|Outcome|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was the same as the subject's daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654266|NCT02192814|E1|Reported Event|Lacosamide (LCM)|"On Day - 1, Lacosamide (LCM) oral tablets were administered in accordance with each subject's LCM dosage regimen in EP0009 (NCT01832038). The oral tablets were taken from EP0009 supply.~During the Treatment Period, subjects received a 30-minute infusion of intravenous (iv) LCM twice daily, once in the morning and once in the evening, for 5 days.~The daily dose of iv LCM was be the same as the subject's current daily dose of oral LCM in EP0009 (200 - 400 mg/day)."
654267|NCT02192684|B3|Baseline|Total|Total of all reporting groups
654268|NCT02192684|B2|Baseline|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
654269|NCT02192684|B1|Baseline|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
654270|NCT02192684|P2|Participant Flow|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
654271|NCT02192684|P1|Participant Flow|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
654272|NCT02192684|O2|Outcome|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
654273|NCT02192684|O1|Outcome|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
654274|NCT02192684|E2|Reported Event|Placebo|"Placebo, one pill daily~placebo: Compare with pioglitazone"
654275|NCT02192684|E1|Reported Event|Pioglitazone|"pioglitazone 45 mg, oral, daily~Pioglitazone: 45 mg daily Insulin sensitizing"
654276|NCT02191865|B4|Baseline|Total|Total of all reporting groups
654277|NCT02191865|B3|Baseline|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
654278|NCT02191865|B2|Baseline|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
654279|NCT02191865|B1|Baseline|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
654280|NCT02191865|P3|Participant Flow|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
654281|NCT02191865|P2|Participant Flow|Child Pugh B|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
654282|NCT02191865|P1|Participant Flow|Child Pugh A|"Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).~Subjects were dosed in a 3 plus 5 design, where a subgroup of 3 subjects was dosed and safety was evaluated formally at a safety meeting prior to dosing the remaining 5 subjects in the group."
654283|NCT02191865|O3|Outcome|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
654284|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
654285|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
654286|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
654287|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
654988|NCT02182895|E2|Reported Event|Standard Therapy Group|No saxagliptin treatment
654290|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
654291|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
654292|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of 100 mg Nintedanib with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
654293|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
654294|NCT02191865|O4|Outcome|Healthy Matched Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh B) impaired subjects .
654295|NCT02191865|O3|Outcome|Healthy Matched Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in healthy control subjects matched with hepatic (Child pugh A) impaired subjects
654296|NCT02191865|O2|Outcome|Child-Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
654297|NCT02191865|O1|Outcome|Child-Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
654298|NCT02191865|E3|Reported Event|Healthy|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in subjects with normal hepatic function.
654299|NCT02191865|E2|Reported Event|Child Pugh B|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with moderate hepatic impairment (Child-Pugh B).
654300|NCT02191865|E1|Reported Event|Child Pugh A|Oral administration of 1 soft gelatin capsule of Nintedanib 100 mg with 240 ml of water under fed conditions in patients with mild hepatic impairment (Child-Pugh A).
654301|NCT02191046|B3|Baseline|Total|Total of all reporting groups
654302|NCT02191046|B2|Baseline|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
654303|NCT02191046|B1|Baseline|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
654304|NCT02191046|P2|Participant Flow|Squeezable Bottle|"nasal irrigation with squeezable bottle by using buffer hypertonic saline about 100-240 ml until no nasal discharge~squeezable bottle: nasal irrigation twice daily for 2 weeks period"
654305|NCT02191046|P1|Participant Flow|Syringe 20 ml|"nasal irrigation with syringe by using buffer hypertonic saline about 100-240 ml until no nasal discharge~syringe 20 ml: nasal irrigation twice daily for 2 weeks period"
654306|NCT02191046|O2|Outcome|Squeezable Bottle|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect and significant improve in 5-s score and satisfaction when compare to syringe group
654307|NCT02191046|O1|Outcome|Syringe 20 ml|improve 5-s score at 2 week period after treatment when compare to the beginning status with minimal side effect
654308|NCT02191046|E2|Reported Event|Squeezable Bottle|record adverse event at baseline and daily adverse events until 2 weeks after treatment
654309|NCT02191046|E1|Reported Event|Syringe 20 ml|record adverse event at baseline and daily adverse events until 2 weeks after treatment
654310|NCT02191033|B3|Baseline|Total|Total of all reporting groups
654311|NCT02191033|B2|Baseline|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
654312|NCT02191033|B1|Baseline|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Text messaging~Nicotine patch"
654313|NCT02191033|P2|Participant Flow|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
654314|NCT02191033|P1|Participant Flow|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
654315|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
654316|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
654317|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
654318|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
654319|NCT02191033|O2|Outcome|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
654320|NCT02191033|O1|Outcome|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
654321|NCT02191033|E2|Reported Event|Standard of Care|"Smoking counseling, nicotine patch~Smoking counseling~Nicotine patch"
654322|NCT02191033|E1|Reported Event|Text Messaging|"Smoking counseling, nicotine patch, text messaging~Smoking counseling~Nicotine patch~Text messaging"
654323|NCT02190591|B3|Baseline|Total|Total of all reporting groups
654324|NCT02190591|B2|Baseline|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
654325|NCT02190591|B1|Baseline|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
654326|NCT02190591|P2|Participant Flow|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
654327|NCT02190591|P1|Participant Flow|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
654328|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
669373|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
654329|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
654455|NCT02189252|O3|Outcome|Lovaza 4 g|Once daily (QD)
654331|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
654332|NCT02190591|O2|Outcome|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
654333|NCT02190591|O1|Outcome|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
654334|NCT02190591|E2|Reported Event|Peanut Labor Ball|"Use of the peanut labor ball within 30 minutes after epidural placement~Peanut Labor Ball: Peanut Labor Ball"
654335|NCT02190591|E1|Reported Event|Pillow and Wedge|Receiving standard care for positioning during labor using pillows and wedges
654336|NCT02190435|B3|Baseline|Total|Total of all reporting groups
654337|NCT02190435|B2|Baseline|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
654338|NCT02190435|B1|Baseline|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
654339|NCT02190435|P2|Participant Flow|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
654340|NCT02190435|P1|Participant Flow|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
654341|NCT02190435|O2|Outcome|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
654342|NCT02190435|O1|Outcome|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
654343|NCT02190435|O2|Outcome|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
654344|NCT02190435|O1|Outcome|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
654345|NCT02190435|E2|Reported Event|Control|Patients that receive intramedullary nail fixation without use of the ADAPT system
654346|NCT02190435|E1|Reported Event|ADAPT|"Patients that receive intramedullary nail fixation with use of the ADAPT system~Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3"
654347|NCT02189954|B3|Baseline|Total|Total of all reporting groups
654348|NCT02189954|B2|Baseline|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
654349|NCT02189954|B1|Baseline|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
654350|NCT02189954|P2|Participant Flow|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group Pressure Limiting (PL)), n=45) cuff inner pressure was held below 60 centimeter of water (cmH2O) (44 mmHg)"
654351|NCT02189954|P1|Participant Flow|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique® (LMU) was lubricated with a water-based gel and the cuff was completely deflated. After induction when bispectral index (BIS) values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
654352|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
654353|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
654354|NCT02189954|O2|Outcome|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
654355|NCT02189954|O1|Outcome|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
654356|NCT02189954|E2|Reported Event|Group Pressure Limiting|"Cuff inner pressure was held below 44 mmHg~Cuff inner pressure was held below 44 mmHg: cuff pressure limitation (Group PL, n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)"
654357|NCT02189954|E1|Reported Event|Group Routine Care|"The placement according to the manufacturer's instructions.~The placement according to the manufacturer's instructions: Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience"
669374|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
654358|NCT02189941|B1|Baseline|Healthy Volunteers|Subjects received one dose of deferiprone sustained-release tablets under fed conditions, one dose of deferiprone sustained-release tablets under fasting conditions, and one dose of deferiprone immediate-release tablets under fasting conditions, 7 days apart
654359|NCT02189941|P3|Participant Flow|Ferriprox Fasting, Then DFP-SR Fed, Then DFP-SR Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions"
654360|NCT02189941|P2|Participant Flow|DFP-SR Fasting, Then Ferriprox Fasting, Then DFP-SR Fed|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release tablets under fasting conditions~One dose of deferiprone sustained-release tablets under fed conditions"
654361|NCT02189941|P1|Participant Flow|DFP-SR Fed, Then DFP-SR Fasting, Then Ferriprox Fasting|"Subjects received 3 treatments in the following order, with a 7-day washout period between treatments:~One dose of deferiprone sustained-release (DFP-SR) tablets under fed conditions~One dose of deferiprone sustained-release tablets under fasting conditions~One dose of Ferriprox immediate-release (IR) tablets under fasting conditions"
654362|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
654363|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654364|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654365|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
654366|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654367|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654368|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
654369|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654370|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654371|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
654372|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654373|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654374|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
654375|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654376|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654377|NCT02189941|O3|Outcome|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
654378|NCT02189941|O2|Outcome|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654379|NCT02189941|O1|Outcome|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654380|NCT02189941|E3|Reported Event|Deferiprone Immediate-release (Fasting)|"A single 2000 mg dose of Deferiprone immediate-release under fasting conditions.~Deferiprone immediate-release: Deferiprone immediate-release tablets"
654381|NCT02189941|E2|Reported Event|Deferiprone Sustained-release (Fasting)|"A single 2000 mg dose of deferiprone sustained-release under fasting conditions.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654382|NCT02189941|E1|Reported Event|Deferiprone Sustained-release (Fed)|"A single 2000 mg dose of deferiprone sustained-release following a high fat high calorie breakfast.~Deferiprone sustained-release: Deferiprone sustained-release tablets"
654383|NCT02189915|B1|Baseline|Creatine Monohydrate|Creatine monohydrate
654384|NCT02189915|P1|Participant Flow|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
654385|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
654386|NCT02189915|O1|Outcome|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
654387|NCT02189915|E1|Reported Event|Creatine Monohydrate Treatment|This study is an open label study, where all participants received Creatine monohydrate.
654388|NCT02189863|B1|Baseline|Overall|Lotrafilcon B MV and lotrafilcon B MF contact lenses worn in Period 1 and Period 2, as randomized
654389|NCT02189863|P2|Participant Flow|AOAMF, Then AOAMV|Lotrafilcon B MF contact lenses worn for 2 weeks in Period 1, followed by lotrafilcon B MV contact lenses worn for 2 weeks in Period 2
654456|NCT02189252|O2|Outcome|Epanova 4 g|Once daily (QD)
654390|NCT02189863|P1|Participant Flow|AOAMV, Then AOAMF|Lotrafilcon B MV contact lenses (AOAMV) worn for 2 weeks in Period 1, followed by lotrafilcon B MF contact lenses (AOAMF) worn for 2 weeks in Period 2
654391|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
654392|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
654393|NCT02189863|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
654394|NCT02189863|O1|Outcome|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
654395|NCT02189863|E5|Reported Event|Habitual|Contact lenses worn in both eyes per subject's habitual prescription on Day 1, Period 1, for a same-day assessment
654396|NCT02189863|E4|Reported Event|Biofinity MF|Comfilcon A multifocal contact lenses worn in both eyes during Period 2 for a same-day assessment
654397|NCT02189863|E3|Reported Event|Lotra B SVD|Lotrafilcon B spherical contact lenses worn with both eyes corrected for distance during Period 1 for a same-day assessment
654398|NCT02189863|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn in both eyes for 2 weeks
654399|NCT02189863|E1|Reported Event|AOAMV|Lotrafilcon B spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near for 2 weeks
654400|NCT02189837|B5|Baseline|Total|Total of all reporting groups
654401|NCT02189837|B4|Baseline|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654402|NCT02189837|B3|Baseline|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654403|NCT02189837|B2|Baseline|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654404|NCT02189837|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654405|NCT02189837|P4|Participant Flow|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654406|NCT02189837|P3|Participant Flow|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654407|NCT02189837|P2|Participant Flow|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654408|NCT02189837|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654409|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654410|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654411|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654412|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654413|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654414|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654415|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654416|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654417|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654418|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654419|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654420|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654421|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654422|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654423|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654424|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654425|NCT02189837|O4|Outcome|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
669375|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
654426|NCT02189837|O3|Outcome|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654427|NCT02189837|O2|Outcome|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654428|NCT02189837|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654429|NCT02189837|E4|Reported Event|Evolocumab and Atorvastatin|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654430|NCT02189837|E3|Reported Event|Evolocumab|Participants received 420 mg evolocumab by subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654431|NCT02189837|E2|Reported Event|Atorvastatin|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and 80 mg atorvastatin orally once a day for up to 8 weeks.
654432|NCT02189837|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 2 weeks on days 1, 15, 29 and 43 and placebo tablets once a day for up to 8 weeks.
654433|NCT02189317|B3|Baseline|Total|Total of all reporting groups
654434|NCT02189317|B2|Baseline|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654435|NCT02189317|B1|Baseline|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654436|NCT02189317|P2|Participant Flow|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654437|NCT02189317|P1|Participant Flow|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654438|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654439|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654440|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654441|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654442|NCT02189317|O2|Outcome|Exparel (Liposomal Bupivacaine)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654443|NCT02189317|O1|Outcome|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654444|NCT02189317|E2|Reported Event|Exparel (Bupivacaine Liposome)|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654445|NCT02189317|E1|Reported Event|Bupivacaine HCl|Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.
654446|NCT02189252|B5|Baseline|Total|Total of all reporting groups
654447|NCT02189252|B4|Baseline|Treatment Sequence 4|Lovaza 4 g per day:Epanova 2 g per day: 4 subjects
654448|NCT02189252|B3|Baseline|Treatment Sequence 3|Epanova 2 g per day:Lovaza 4 g per day
654449|NCT02189252|B2|Baseline|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
654450|NCT02189252|B1|Baseline|Treatment Sequence 1|Epanova 4 g per day:Lovaza 4 g per day
654451|NCT02189252|P4|Participant Flow|Treatment Sequence 4|Lovaza 4g per day:Epanova 2g per day:
654452|NCT02189252|P3|Participant Flow|Treatment Sequence 3|Epanova 2g per day:Lovaza 4g per day:
654453|NCT02189252|P2|Participant Flow|Treatment Sequence 2|Lovaza 4 g per day:Epanova 4 g per day : 4 subjects
654454|NCT02189252|P1|Participant Flow|Treatment Sequence 1|Epanova 4g per day: Lovaza 4g per day
654485|NCT02189161|B1|Baseline|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
654486|NCT02189161|P1|Participant Flow|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
654487|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
654488|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
654489|NCT02189161|O1|Outcome|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
654490|NCT02189161|E1|Reported Event|Radiofrequency Ablation|"circumferential radiofrequency ablation (RFA) to the anal canal~Radiofrequency Ablation (Barrx™): Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2."
654491|NCT02189122|B3|Baseline|Total|Total of all reporting groups
654492|NCT02189122|B2|Baseline|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654493|NCT02189122|B1|Baseline|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654545|NCT02188589|P1|Participant Flow|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
654546|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
654989|NCT02182895|E1|Reported Event|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654494|NCT02189122|P2|Participant Flow|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence NHP544C 81 mg, NHP544C 162 mg, placebo; two subjects participated in the sequence NHP544C 162 mg, placebo, NHP544C 81 mg."
654495|NCT02189122|P1|Participant Flow|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days.~Three subjects participated in each possible sequence with the following exceptions: Four subjects participated in the sequence Aspirin 81 mg, Aspirin 162.5 mg, placebo; two subjects participated in the sequence placebo, Aspirin 162.5 mg, Aspirin 81 mg."
654496|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654497|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654498|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654499|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654500|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654501|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654502|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654503|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654504|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654505|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654547|NCT02188589|O1|Outcome|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
654506|NCT02189122|O2|Outcome|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to the order in which they receive NHP-544C 81 mg, NPH-544C 162.5 mg and identical-appearing placebo for five days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654507|NCT02189122|O1|Outcome|Group 1:Aspirin/Placebo|"Group 1 will be randomized to the order in which they receive rapid-release aspirin (ASA), 81 mg), ASA 162.5 mg, and identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of each treatment period.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654508|NCT02189122|E2|Reported Event|Group 2:NHP-544C/Placebo|"Group 2 will be randomized to receive NHP-544C 81 mg, NPH-544C 162.5 mg or placebo. Bradykinin will be given intravenously in graded doses on the fifth day of study drug.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~NHP544-C 81 mg: Subjects will take NHP544C 81 mg per day for five days.~NHP544C 162 mg: Subjects will take NHP544C 162 mg once a day for five days.~Placebo: Subjects will take matching placebo for five days."
654509|NCT02189122|E1|Reported Event|Group 1:Aspirin/Placebo|"Group 1 will be randomized to receive rapid release aspirin (ASA, 81 mg), ASA 162.5 mg, or identical-appearing placebo for 5 days. Bradykinin will be given intravenously in graded doses on the fifth day of study.~Bradykinin: Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.~Aspirin 81 mg: Subjects will take Aspirin 81 mg per day for five days.~Aspirin 162 mg: Subjects will take aspirin 162 mg per day for 5 days.~Placebo: Subjects will take matching placebo for five days."
654510|NCT02188849|B3|Baseline|Total|Total of all reporting groups
654561|NCT02187744|B1|Baseline|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654511|NCT02188849|B2|Baseline|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
654512|NCT02188849|B1|Baseline|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
654513|NCT02188849|P2|Participant Flow|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
654514|NCT02188849|P1|Participant Flow|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
654515|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
654516|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
654517|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
654518|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
654548|NCT02188589|E1|Reported Event|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
654549|NCT02187809|B1|Baseline|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654990|NCT02181790|B3|Baseline|Total|Total of all reporting groups
654519|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
654520|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
654521|NCT02188849|O2|Outcome|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
654522|NCT02188849|O1|Outcome|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
654830|NCT02185105|O2|Outcome|Comfilcon A Toric|
654523|NCT02188849|E2|Reported Event|Placebo|"Maltodextrin 5 g/day to be dissolved in water~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant."
654524|NCT02188849|E1|Reported Event|Creatine|"Creatine 5 g/ day~Resistance exercise training: All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.~Creatine: Creatine powder 5 g day"
654525|NCT02188784|B3|Baseline|Total|Total of all reporting groups
654526|NCT02188784|B2|Baseline|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654527|NCT02188784|B1|Baseline|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654528|NCT02188784|P2|Participant Flow|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654529|NCT02188784|P1|Participant Flow|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654530|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654531|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654532|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654533|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654534|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654535|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654536|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654537|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654538|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654539|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654540|NCT02188784|O2|Outcome|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654541|NCT02188784|O1|Outcome|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654542|NCT02188784|E2|Reported Event|Placebo (for Polysaccharide Iron Complex 150 mg)|"Oral placebo twice a day for 16 weeks~Placebo (for Polysaccharide Iron Complex): Sugar capsule designed to mimic Polysaccharide Iron Complex."
654543|NCT02188784|E1|Reported Event|Polysaccharide Iron Complex 150 mg|"oral Fe polysaccharide 150mg twice daily for 16 weeks~Polysaccharide Iron Complex 150 mg: Oral Iron"
654544|NCT02188589|B1|Baseline|Treatment Group|Nasal implant: Treatment group may receive bilateral nasal implants (maximum of 4, 2 per side)
654550|NCT02187809|P1|Participant Flow|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654551|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654552|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654553|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654554|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654555|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654556|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654557|NCT02187809|O1|Outcome|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654558|NCT02187809|E1|Reported Event|Clobazam|"A maximum of 2.0 mg/kg/day (maximum 80 mg/day) twice daily (BID); clobazam oral suspension (2.5 mg/mL) or clobazam scored tablets (10 mg), orally~Clobazam"
654559|NCT02187744|B3|Baseline|Total|Total of all reporting groups
654560|NCT02187744|B2|Baseline|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654562|NCT02187744|P2|Participant Flow|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654563|NCT02187744|P1|Participant Flow|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin area under the concentration versus time curve (AUC) 6 were administered on Day 1 of each cycle.
654564|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654565|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654566|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654567|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654568|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654569|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654570|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654571|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654572|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654573|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654574|NCT02187744|O2|Outcome|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654575|NCT02187744|O1|Outcome|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654576|NCT02187744|E2|Reported Event|Trastuzumab-EU|Participants received a loading dose of 8 mg/kg of trastuzumab-EU on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654577|NCT02187744|E1|Reported Event|PF-05280014|Participants received a loading dose of 8 mg/kg of PF-05280014 on Cycle 1 Day 1. Subsequent infusions followed every 3 weeks with a dose of 6 mg/kg. Taxotere 75 mg/m2 and carboplatin AUC 6 were administered on Day 1 of each cycle.
654578|NCT02187029|B5|Baseline|Total|Total of all reporting groups
655132|NCT02180061|B1|Baseline|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
654579|NCT02187029|B4|Baseline|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654580|NCT02187029|B3|Baseline|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654581|NCT02187029|B2|Baseline|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654582|NCT02187029|B1|Baseline|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654583|NCT02187029|P4|Participant Flow|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654584|NCT02187029|P3|Participant Flow|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654585|NCT02187029|P2|Participant Flow|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654586|NCT02187029|P1|Participant Flow|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654587|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654588|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654589|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654590|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654591|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654592|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654593|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654594|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654595|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654596|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654597|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654598|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654599|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654600|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654601|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654602|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654603|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654604|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654605|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654606|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654607|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654608|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654609|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654610|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654611|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654612|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654613|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654614|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654615|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654616|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654617|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654618|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654619|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654689|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654620|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654621|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654622|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654623|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654624|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654625|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654626|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654627|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654628|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654629|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654630|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654631|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654632|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654633|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654634|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654635|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654636|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654637|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654638|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654639|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654640|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
669376|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
654641|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654642|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654643|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654644|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654645|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654646|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654647|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654648|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654649|NCT02187029|O4|Outcome|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654690|NCT02187016|E4|Reported Event|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654650|NCT02187029|O3|Outcome|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654651|NCT02187029|O2|Outcome|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654652|NCT02187029|O1|Outcome|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654653|NCT02187029|E4|Reported Event|Cohort 1 and 2: Placebo|Participants received placebo matched tablet orally once daily . Participants in Cohort 1 received placebo for 14 days and participants in Cohort 2 received placebo for 2 days before the study was terminated for safety reasons.
654654|NCT02187029|E3|Reported Event|Cohort 2: PF-06743649 5 mg|Participants received PF-06743649 5 mg tablets QD for 2 days before the study was terminated for safety reasons. This cohort was stopped after acute kidney injury was reported in 1 participant.
654655|NCT02187029|E2|Reported Event|Cohort 1: PF-06743649 40 mg|Prior to dose titration, participants received PF-06743649 40 mg tablet orally QD for 14 days.
654656|NCT02187029|E1|Reported Event|Cohort 1: PF-06743649 2.5 mg to 10 mg|Following a dose titration regimen, participants received PF-06743649 2.5 mg tablet orally once daily (QD) for 8 days, followed by PF-06743649 10 mg QD for 6 days.
654657|NCT02187016|B5|Baseline|Total|Total of all reporting groups
654658|NCT02187016|B4|Baseline|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654659|NCT02187016|B3|Baseline|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654660|NCT02187016|B2|Baseline|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654661|NCT02187016|B1|Baseline|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654662|NCT02187016|P4|Participant Flow|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654663|NCT02187016|P3|Participant Flow|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654664|NCT02187016|P2|Participant Flow|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654665|NCT02187016|P1|Participant Flow|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654666|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654667|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654668|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654669|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654670|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654671|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654672|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654673|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654674|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654675|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654676|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654677|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654678|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654679|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654680|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654681|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654682|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654683|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654684|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654685|NCT02187016|O1|Outcome|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654686|NCT02187016|O4|Outcome|Manual Toothbrush|Manual Toothbrush is used twice a day for 1 minute
654687|NCT02187016|O3|Outcome|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654688|NCT02187016|O2|Outcome|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654831|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
654691|NCT02187016|E3|Reported Event|String Floss|String Floss interproximal cleaning device is applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute
654692|NCT02187016|E2|Reported Event|AirFloss + Rinse2|AirFloss interproximal cleaning device with Listerine applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654693|NCT02187016|E1|Reported Event|AirFloss + Rinse1|AirFloss interproximal cleaning device with BreathRx applied once a day between the teeth with Manual Tooth brushing twice a day for 1 minute.
654694|NCT02186808|B1|Baseline|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
654695|NCT02186808|P1|Participant Flow|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
654696|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
654697|NCT02186808|O1|Outcome|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
654698|NCT02186808|E1|Reported Event|Procera® Bridge Zirconia|"Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.~Procera® Bridge Zirconia: Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible."
654699|NCT02186665|B3|Baseline|Total|Total of all reporting groups
654700|NCT02186665|B2|Baseline|Placebo|Placebo comparator
654701|NCT02186665|B1|Baseline|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
654702|NCT02186665|P2|Participant Flow|Placebo|Placebo comparator
654703|NCT02186665|P1|Participant Flow|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
654704|NCT02186665|O2|Outcome|Placebo|Placebo Comparator
654705|NCT02186665|O1|Outcome|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
654706|NCT02186665|E2|Reported Event|Placebo|Placebo Comparator
654707|NCT02186665|E1|Reported Event|Calcitriol Ointment|Calcitriol 3 mcg/g Ointment
654708|NCT02186587|B3|Baseline|Total|Total of all reporting groups
654709|NCT02186587|B2|Baseline|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant as part of standard of care.~Off-the-shelf total knee implant"
654710|NCT02186587|B1|Baseline|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
654711|NCT02186587|P2|Participant Flow|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
654712|NCT02186587|P1|Participant Flow|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
654713|NCT02186587|O1|Outcome|ConforMIS|"Subjects in this arm will be having a ConforMIS custom total knee implant as part of standard of care.~ConforMIS custom total knee"
654714|NCT02186587|E2|Reported Event|Off-the-shelf|"Subjects in this arm will receive an off-the-shelf total knee implant.~Off-the-shelf total knee implant"
654715|NCT02186587|E1|Reported Event|ConforMIS|"Subjects in this arm will receive a ConforMIS custom total knee implant.~ConforMIS custom total knee"
654716|NCT02186223|B1|Baseline|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654717|NCT02186223|P1|Participant Flow|The Angel® Catheter|"All eligible subjects will receive an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654718|NCT02186223|O1|Outcome|Angel® Catheter Pre-Removal Cavogram|Number analyzed includes all subjects that had an Angel® Catheter placed, and a cavogram was performed prior to removal.
654719|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654720|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654721|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654832|NCT02185105|O2|Outcome|Comfilcon A Toric|
654833|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
654722|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654723|NCT02186223|O1|Outcome|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654724|NCT02186223|E1|Reported Event|The Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter: The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein."
654725|NCT02185729|B1|Baseline|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
654726|NCT02185729|P1|Participant Flow|Healthy Volunteer|"Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)~Intralipid~ClinOleic~Dextrose~Saline (control)"
654727|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
654728|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
654729|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
654730|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
654731|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
654732|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
654733|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
654734|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
654735|NCT02185729|O4|Outcome|Saline|Healthy subjects receive 24-hour infusion of normal saline (control)
654736|NCT02185729|O3|Outcome|Dextrose|Healthy subjects receive 24-hour TPN infusion of dextrose (sugar) without fat
654737|NCT02185729|O2|Outcome|ClinOleic|Healthy subjects receive 24-hour TPN infusion of ClinOleic (olive oil)
654738|NCT02185729|O1|Outcome|Intralipid|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat)
654739|NCT02185729|E1|Reported Event|Healthy Volunteer|Healthy subjects receive 24-hour TPN infusion of Intralipid (soybean-derived fat), ClinOleic (olive oil), dextrose (sugar) without fat, and a 24-hour infusion of normal saline (control)
654740|NCT02185534|B7|Baseline|Total|Total of all reporting groups
654741|NCT02185534|B6|Baseline|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
654742|NCT02185534|B5|Baseline|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
655281|NCT02178787|E1|Reported Event|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
654743|NCT02185534|B4|Baseline|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
654744|NCT02185534|B3|Baseline|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
654745|NCT02185534|B2|Baseline|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
654746|NCT02185534|B1|Baseline|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
654747|NCT02185534|P6|Participant Flow|First US, Then Japanese, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
654806|NCT02185105|B1|Baseline|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654748|NCT02185534|P5|Participant Flow|First US, Then European, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 1, a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
654749|NCT02185534|P4|Participant Flow|First Japanese, Then US, Then European Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 3
654750|NCT02185534|P3|Participant Flow|First Japanese, Then European, Then US Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi-Aventis, reference) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3
654751|NCT02185534|P2|Participant Flow|First European, Then US, Then Japanese Clopidogrel|A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA - test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi-Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 3
654752|NCT02185534|P1|Participant Flow|First European, Then Japanese, Then US Clopidogrel|"A single oral dose of clopidogrel 75 mg filmcoated tablet (Zyllt, KRKA~- test) in Period 1; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Brystol-Myer Squibb, Sanofi- Aventis, reference) in Period 2; a single oral dose of clopidogrel 75 mg filmcoated tablet (Plavix®, Sanofi- Aventis, reference) in Period 3"
654753|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
654754|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
654755|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
654756|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
654757|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
654758|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
654759|NCT02185534|O3|Outcome|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
654760|NCT02185534|O2|Outcome|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
654761|NCT02185534|O1|Outcome|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
654762|NCT02185534|E4|Reported Event|Total Number of Participants|total number of subjects exposed to any treatment
654763|NCT02185534|E3|Reported Event|US Clopidogrel Tablets, 75 mg|Treatment C: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Sanofi-Aventis, reference)
654764|NCT02185534|E2|Reported Event|Japanese Clopidogrel Tablets, 75 mg|Treatment B: a single oral dose of clopidogrel 75 mg film-coated tablet (Plavix®, Brystol-Myer Squibb,Sanofi- Aventis, reference)
654765|NCT02185534|E1|Reported Event|European Clopidogrel Tablets, 75 mg|Treatment A: a single oral dose of clopidogrel 75 mg film-coated tablet Eu(Zyllt, KRKA - test)
654766|NCT02185339|B3|Baseline|Total|Total of all reporting groups
654767|NCT02185339|B2|Baseline|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654955|NCT02183675|E3|Reported Event|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
654768|NCT02185339|B1|Baseline|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654769|NCT02185339|P2|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654807|NCT02185105|P1|Participant Flow|Comfilcon A XR Toric (Extended Range) / Comfilcon A Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654808|NCT02185105|O2|Outcome|Comfilcon A Toric|
654809|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
654810|NCT02185105|O2|Outcome|Comfilcon A Toric|
654811|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
654770|NCT02185339|P1|Participant Flow|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654771|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654772|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654773|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654774|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654775|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654776|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654777|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654851|NCT02184624|B4|Baseline|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
655282|NCT02178540|B1|Baseline|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
654778|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654779|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654780|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654781|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654782|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654783|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654784|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654785|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654786|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654787|NCT02185339|O2|Outcome|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654852|NCT02184624|B3|Baseline|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654956|NCT02183675|E2|Reported Event|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
654788|NCT02185339|O1|Outcome|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654789|NCT02185339|E2|Reported Event|Moderate Neuromuscular Blockade (Moderate NMB) Group|For patients randomized to the mNMB group, intravenous infusion of 0.2 mg/kg/h rocuronium was administered 30 minutes after the administration of intubation dose or after the appearance of train-of-four (TOF) count, whichever came first. Then, the infusion rate was titrated according to TOF (target to keep TOF between 1 to 2). Infusion rate was increased or reduced at a rate of 0.1 mg/kg/h if TOF is > or < than 1-2. A dose of sugammadex (2 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654790|NCT02185339|E1|Reported Event|Deep Neuromuscular Blockade (Deep NMB) Group|For patients randomized to the dNMB group, intravenous infusion of 0.6 mg/kg/h rocuronium was administered 10 minutes after the administration of intubation dose or after the return of post-tetanic count (PTC), whichever came first. Then, the infusion rate was titrated according to PTC (target to keep PTC between 1 and 2). Infusion rate was increased or be reduced at a rate of 0.1 mg/kg/h if PTC is > or < than 1-2 to maintain deep muscle relaxation throughout the surgery. Neuromuscular monitoring was carried out by monitoring the adductor pollicis muscle in response to ulnar nerve stimulation. A dose of sugammadex (4 mg/kg) was administered at the end of the surgery. Patients were extubated when the train of four ratio was ≥0.9.
654791|NCT02185183|B1|Baseline|AlequelTM|"AlequelTM~Alequel: Alequel"
654792|NCT02185183|P1|Participant Flow|AlequelTM 30 ng Once a Day Orally|"AlequelTM 30 ng once a day orally~Alequel: Alequel"
654793|NCT02185183|O1|Outcome|AlequelTM|"AlequelTM~Alequel: Alequel"
654794|NCT02185183|E1|Reported Event|AlequelTM|"AlequelTM~Alequel: Alequel"
654795|NCT02185131|B3|Baseline|Total|Total of all reporting groups
654796|NCT02185131|B2|Baseline|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654797|NCT02185131|B1|Baseline|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654798|NCT02185131|P2|Participant Flow|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654799|NCT02185131|P1|Participant Flow|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654800|NCT02185131|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654801|NCT02185131|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654802|NCT02185131|O2|Outcome|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654803|NCT02185131|O1|Outcome|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654853|NCT02184624|B2|Baseline|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654804|NCT02185131|E2|Reported Event|Placebo|"Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654805|NCT02185131|E1|Reported Event|Mirtazapine|"Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Mirtazapine: Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.~Placebo: Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects."
654812|NCT02185105|O2|Outcome|Comfilcon A Toric|
654813|NCT02185105|O1|Outcome|Comflicon A XR Toric (Extended Range)|
654814|NCT02185105|O2|Outcome|Comfilcon A Toric|
654834|NCT02185105|O2|Outcome|Comfilcon A Toric|
654835|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
654836|NCT02185105|O3|Outcome|No Preference|
654837|NCT02185105|O2|Outcome|Comfilcon A Toric|
654838|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
654839|NCT02185105|O2|Outcome|Comfilcon A Toric|
654840|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|
654841|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654842|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654843|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654844|NCT02185105|O1|Outcome|Comfilcon A XR Toric (Extended Range)|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654845|NCT02185105|O2|Outcome|Comfilcon A Toric|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A XR: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654846|NCT02185105|O1|Outcome|Comfilcon A XR (Extended Range) Toric|"Subjects were randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654847|NCT02185105|E2|Reported Event|Comfilcon A|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A MTO: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654848|NCT02185105|E1|Reported Event|Comfilcon A MTO|"Subjects will be randomized to receive either the Test or Control lens as a matched pair at each visit per a predetermined randomization schedule.~comfilcon A: Randomized to a test lens in one eye and control lens in the other as a matched pair."
654849|NCT02184624|B6|Baseline|Total|Total of all reporting groups
654850|NCT02184624|B5|Baseline|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654978|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
654854|NCT02184624|B1|Baseline|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654855|NCT02184624|P5|Participant Flow|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654856|NCT02184624|P4|Participant Flow|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654857|NCT02184624|P3|Participant Flow|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654858|NCT02184624|P2|Participant Flow|Sub-study 2: ELLIPTA Vs Metered-dose Inhaler (MDI)|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654859|NCT02184624|P1|Participant Flow|Sub-study 1:ELLIPTA Versus (Vs) DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily Chronic Obstructive Pulmonary Disease (COPD) maintenance and other medication(s) during the study.
654860|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654861|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654862|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654863|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654864|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654865|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
655074|NCT02180893|B1|Baseline|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
654866|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654867|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654868|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654869|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654870|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654871|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654872|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654873|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654874|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654875|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654876|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654877|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654878|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654879|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654880|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654881|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654882|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654883|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654884|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654885|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654886|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654887|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654888|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654889|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
655040|NCT02181504|P3|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
654890|NCT02184624|O5|Outcome|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654891|NCT02184624|O4|Outcome|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654892|NCT02184624|O3|Outcome|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654893|NCT02184624|O2|Outcome|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654894|NCT02184624|O1|Outcome|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654895|NCT02184624|E5|Reported Event|Sub-study 5: ELLIPTA Vs BREEZHALER|Participants received placebo via the ELLIPTA inhaler first and then BREEZHALER or BREEZHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654896|NCT02184624|E4|Reported Event|Sub-study 4: ELLIPTA Vs HANDIHALER|Participants received placebo via the ELLIPTA inhaler first and then HANDIHALER or HANDIHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654897|NCT02184624|E3|Reported Event|Sub-study 3: ELLIPTA Vs TURBUHALER|Participants received placebo via the ELLIPTA inhaler first and then TURBUHALER or TURBUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654898|NCT02184624|E2|Reported Event|Sub-study 2: ELLIPTA Vs MDI|Participants received placebo via the ELLIPTA inhaler first and then MDI or MDI first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654899|NCT02184624|E1|Reported Event|Sub-study 1:ELLIPTA Vs DISKUS/ACCUHALER|Participants received placebo via the ELLIPTA inhaler first and then DISKUS/ACCUHALER or DISKUS/ACCUHALER first and then ELLIPTA on Day 1. Participants continued to use their usual daily COPD maintenance and other medication(s) during the study.
654900|NCT02184494|B4|Baseline|Total|Total of all reporting groups
654901|NCT02184494|B3|Baseline|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654979|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654902|NCT02184494|B2|Baseline|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654903|NCT02184494|B1|Baseline|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654904|NCT02184494|P3|Participant Flow|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654905|NCT02184494|P2|Participant Flow|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654906|NCT02184494|P1|Participant Flow|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654907|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654908|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654909|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654910|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654911|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654912|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654913|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654954|NCT02183675|E4|Reported Event|All Patients|"All participants in the study. Participants received three treatments in a randomised order~T80-A5-H12.5~T80-A5~T80-H12.5"
654980|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
654981|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654914|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654915|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654916|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654917|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654918|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654919|NCT02184494|O3|Outcome|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654920|NCT02184494|O2|Outcome|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654921|NCT02184494|O1|Outcome|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654922|NCT02184494|E3|Reported Event|Blood Lactate Responses in Healthy, Older Adults|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in healthy, older adults. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654923|NCT02184494|E2|Reported Event|Blood Lactate Response in MS|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in an MS population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654924|NCT02184494|E1|Reported Event|Blood Lactate Response in PD|"This arm involves performing 5 sets of 1-minute squats with 1 minute of rest between each, and a finger prick before, after, and 10 minutes after the exercise in a PD population. One set of the squats will be performed on a whole body vibration plate, and one on the ground.~pro5 AIRdaptive Power Plate, Badhoevedorp, The Netherlands: Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.~Whole Body Vibration"
654925|NCT02183675|B7|Baseline|Total|Total of all reporting groups
654926|NCT02183675|B6|Baseline|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
654927|NCT02183675|B5|Baseline|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
669458|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
654928|NCT02183675|B4|Baseline|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
654929|NCT02183675|B3|Baseline|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
654930|NCT02183675|B2|Baseline|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
654931|NCT02183675|B1|Baseline|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
654932|NCT02183675|P6|Participant Flow|T80-H12.5 / T80-A5-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
654933|NCT02183675|P5|Participant Flow|T80-A5-H12.5 / T80-A5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
654934|NCT02183675|P4|Participant Flow|T80-A5 / T80-H12.5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
654935|NCT02183675|P3|Participant Flow|T80-A5 / T80-A5-H12.5 / T80-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)"
655004|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
654936|NCT02183675|P2|Participant Flow|T80-H12.5 / T80-A5 / T80-A5-H12.5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)~Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination tablet (T80-A5-H12.5)"
654937|NCT02183675|P1|Participant Flow|T80-A5-H12.5 / T80-H12.5 / T80-A5|"Participants received the three treatments, the treatments were administered orally in the following order:~Telmisartan 80mg/Amlodipine 5mg/ hydrochlorothiazide (HCTZ) 12.5mg fixed-dose combination tablet (T80-A5-H12.5)~Telmisartan 80mg/ HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5)~Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5)"
654938|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
654939|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654940|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
654941|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654942|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
654943|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654944|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
654945|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654946|NCT02183675|O2|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
654947|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654948|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
654949|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
654950|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654951|NCT02183675|O3|Outcome|T80-H12.5|Participants received oral administration Telmisartan 80mg/HCTZ 12.5mg fixed-dose combination tablet (T80-H12.5) once daily for 10 days
654952|NCT02183675|O2|Outcome|T80-A5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg fixed-dose combination tablet (T80-A5) once daily for 10 days
654953|NCT02183675|O1|Outcome|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654982|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
654957|NCT02183675|E1|Reported Event|T80-A5-H12.5|Participants received oral administration of Telmisartan 80mg/Amlodipine 5mg/HCTZ 12.5mg fixed-dose combination (FDC) tablet (T80-A5-H12.5) once daily for ten days.
654958|NCT02183519|B3|Baseline|Total|Total of all reporting groups
654959|NCT02183519|B2|Baseline|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
654960|NCT02183519|B1|Baseline|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
654961|NCT02183519|P2|Participant Flow|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
654962|NCT02183519|P1|Participant Flow|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
655703|NCT02175121|B6|Baseline|Total|Total of all reporting groups
654963|NCT02183519|O2|Outcome|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
654964|NCT02183519|O1|Outcome|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
654965|NCT02183519|E2|Reported Event|Parkinson's Disease|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
654966|NCT02183519|E1|Reported Event|Healthy Older Adults|All participants will receive reflex and voluntary cough testing. This will include coughing on command (voluntary cough) and coughing in response to capsaicin (reflex cough). This data will me measured to determine the strength of the cough (from both voluntary and reflex cough) and cough sensitivity (reflex cough only). Following baseline reflex and voluntary cough assessment, the participants will be cued to cough long and hard during both reflex and voluntary cough tasks. These data will help the investigators understand the baseline characteristics of voluntary and reflex cough, whether older adults can modify the magnitude of their cough response with verbal and visual cues.
654967|NCT02182895|B3|Baseline|Total|Total of all reporting groups
654968|NCT02182895|B2|Baseline|Standard Therapy Group|Standard therapy group will receive basal-bolus insulin starting at a dose of 0.5 units/kg/day; given half as insulin glargine and half as insulin aspart. In addition, the standard therapy group will receive the correctional sliding scale insulin therapy before each meal and bedtime.
654969|NCT02182895|B1|Baseline|Saxagliptin Group|"DPP4 inhibitor therapy group will receive saxagliptin 2.5 to 5 mg daily in addition to correctional sliding scale insulin therapy before each meal and bedtime.~Saxagliptin: 2.5-5 mg daily"
654970|NCT02182895|P2|Participant Flow|Standard Therapy Group|No saxagliptin treatment
654971|NCT02182895|P1|Participant Flow|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654972|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
654973|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654974|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
654975|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654976|NCT02182895|O2|Outcome|Standard Therapy Group|No saxagliptin treatment
654977|NCT02182895|O1|Outcome|Saxagliptin Group|saxagliptin 2.5-5 mg daily
654991|NCT02181790|B2|Baseline|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654992|NCT02181790|B1|Baseline|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654993|NCT02181790|P2|Participant Flow|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654994|NCT02181790|P1|Participant Flow|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654995|NCT02181790|O2|Outcome|Excimer Laser (Both Palms/Soles)|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654996|NCT02181790|O1|Outcome|Excimer Laser (One Palm/Sole)|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654997|NCT02181790|O2|Outcome|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654998|NCT02181790|O1|Outcome|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
654999|NCT02181790|E2|Reported Event|Second Group|"excimer laser treatment to both palms and/or soles~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
655000|NCT02181790|E1|Reported Event|First Group|"excimer laser treatment to one palm and/or one sole~Excimer laser: twice weekly treatments with the excimer laser for a total of 8 weeks."
655001|NCT02181530|B1|Baseline|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655002|NCT02181530|P1|Participant Flow|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655003|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655039|NCT02181504|B1|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655005|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655006|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655007|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655008|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655009|NCT02181530|O1|Outcome|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655010|NCT02181530|E1|Reported Event|OZURDEX®|Retrospective data collection study of OZURDEX® (dexamethasone intravitreal implant 0.7 mg) administered at least once in accordance with routine clinical practice. No treatment (intervention) is administered as part of this study.
655011|NCT02181517|B4|Baseline|Total|Total of all reporting groups
655012|NCT02181517|B3|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655013|NCT02181517|B2|Baseline|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655014|NCT02181517|B1|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655015|NCT02181517|P3|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655016|NCT02181517|P2|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655017|NCT02181517|P1|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655018|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655019|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655020|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655021|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655022|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655283|NCT02178540|P1|Participant Flow|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
655023|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655024|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655025|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655026|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655027|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655028|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655029|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655030|NCT02181517|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655031|NCT02181517|O2|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655032|NCT02181517|O1|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655033|NCT02181517|E3|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655034|NCT02181517|E2|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655035|NCT02181517|E1|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655036|NCT02181504|B4|Baseline|Total|Total of all reporting groups
655037|NCT02181504|B3|Baseline|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655038|NCT02181504|B2|Baseline|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655041|NCT02181504|P2|Participant Flow|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655042|NCT02181504|P1|Participant Flow|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655043|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655044|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655045|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655046|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655047|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655048|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655049|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655050|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655051|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655052|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655053|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655054|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655055|NCT02181504|O3|Outcome|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655056|NCT02181504|O2|Outcome|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655057|NCT02181504|O1|Outcome|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655058|NCT02181504|E3|Reported Event|Ranibizumab 0.5 mg|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
655059|NCT02181504|E2|Reported Event|Abicipar Pegol 1 mg|Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655060|NCT02181504|E1|Reported Event|Abicipar Pegol 2 mg|Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
655061|NCT02181140|B1|Baseline|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
655062|NCT02181140|P1|Participant Flow|EUS Guided FNA and Fine Needle Punction|"punction of endosonographically identified space-occupying process with aspirating fine needle and pro core fine needle in a randomized order~EUS guided FNA and fine needle punction: punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics"
655063|NCT02181140|O1|Outcome|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
655064|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided Pro core FNA: Histology samples (not cytology)
655065|NCT02181140|O1|Outcome|EUS Guided Pro Core FNA|EUS guided punction of a lesion by pro core fine needle to evacuate histology and smear biologics
655066|NCT02181140|E1|Reported Event|EUS Guided FNA|EUS FNA of lesions with aspirating fine needle and pro core fine needle in a randomized order
655067|NCT02181127|B1|Baseline|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
655068|NCT02181127|P1|Participant Flow|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
655069|NCT02181127|O2|Outcome|Placebo|Glucagon-only Bionic Pancreas delivered placebo during 7 of the 14 days. The order of the placebo days was randomized in blocks of 2, with no more than 2 days in a row of placebo.
655070|NCT02181127|O1|Outcome|Glucagon-only Bionic Pancreas|Glucagon-only Bionic Pancreas delivered glucagon during 7 of the 14 days. The order of the glucagon days was randomized in blocks of 2, with no more than 2 days in a row of glucagon.
655071|NCT02181127|E1|Reported Event|Glucagon-only Bionic Pancreas|"Subjects will use the device every day and will fill the reservoir daily with glucagon or placebo (randomized, double blinded allocation for each day).~Glucagon-only Bionic Pancreas: A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor."
655072|NCT02180893|B3|Baseline|Total|Total of all reporting groups
655073|NCT02180893|B2|Baseline|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
655075|NCT02180893|P2|Participant Flow|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
655076|NCT02180893|P1|Participant Flow|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
655077|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
655078|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
655079|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
655080|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
655081|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
655082|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
655083|NCT02180893|O2|Outcome|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
655084|NCT02180893|O1|Outcome|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valve surgery~Paravertebral Block: Paravertebral nerve block injection"
655085|NCT02180893|E2|Reported Event|No Block|"Patients who did not receive PVB~Placebo Comparator: No block~Patients who did not receive PVB"
655086|NCT02180893|E1|Reported Event|Paravertebral Block|"Patient receiving a PVB prior to robotic mitral valce surgery~Paravertebral Block: Paravertebral nerve block injection"
655087|NCT02180828|B3|Baseline|Total|Total of all reporting groups
655088|NCT02180828|B2|Baseline|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655089|NCT02180828|B1|Baseline|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655090|NCT02180828|P2|Participant Flow|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655091|NCT02180828|P1|Participant Flow|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655092|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655093|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655094|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655095|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655096|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655097|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655098|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655099|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655100|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655101|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655102|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655103|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655104|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655105|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655106|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655107|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655108|NCT02180828|O2|Outcome|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655109|NCT02180828|O1|Outcome|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655110|NCT02180828|E2|Reported Event|Fluconazole|"2 doses of 150 mg oral Fluconazole (at day1 and day4)~Fluconazole: 2 doses of 150 mg oral Fluconazole (at day1 and day4)"
655111|NCT02180828|E1|Reported Event|Clotrimazole Vaginal Tablet|"2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)~Clotrimazole vaginal tablet: 2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)"
655112|NCT02180646|B3|Baseline|Total|Total of all reporting groups
655370|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
655113|NCT02180646|B2|Baseline|High Protein Then High Carb Breakfast|A high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat) for 7 days, followed by a 7-day washout, followed by a high carbohydrate breakfast for 7 days
655114|NCT02180646|B1|Baseline|High Carb Then High Protein Breakfast|A high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat) for 7 days, followed by 7-day washout, followed by a high protein breakfast for 7 days
655115|NCT02180646|P2|Participant Flow|High Protein Then High Carb Breakfast|A high protein breakfast for 7 days, followed by a 7-day washout, followed a high carbohydrate breakfast for 7 days
655116|NCT02180646|P1|Participant Flow|High Carb Then High Protein Breakfast|A high carbohydrate breakfast for 7 days, followed by a 7-day washout, followed a high protein breakfast for 7 days
655117|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655118|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655119|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655120|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655121|NCT02180646|O2|Outcome|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655122|NCT02180646|O1|Outcome|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655123|NCT02180646|E2|Reported Event|High Carbohydrate Breakfast|"a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655124|NCT02180646|E1|Reported Event|High Protein Breakfast|"a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)~high protein breakfast~high carbohydrate breakfast"
655125|NCT02180230|B1|Baseline|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
655126|NCT02180230|P1|Participant Flow|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
655127|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
655128|NCT02180230|O1|Outcome|Shorty Implants|"Brånemark System Mk III Shorty and NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
655129|NCT02180230|E1|Reported Event|Shorty Implants|"Brånemark System Mk III Shorty and/or NobelSpeedy Shorty~Shorty implants: Dental implant insertion to maxilla or mandible"
655130|NCT02180061|B3|Baseline|Total|Total of all reporting groups
655131|NCT02180061|B2|Baseline|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
656424|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
655133|NCT02180061|P2|Participant Flow|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655134|NCT02180061|P1|Participant Flow|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, intravenously (IV) over 30 minutes on Day 1 of each 3-week dosing cycle (Q3W).
655135|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655136|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655137|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655138|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655139|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655140|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655141|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655142|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655143|NCT02180061|O2|Outcome|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655144|NCT02180061|O1|Outcome|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655145|NCT02180061|E2|Reported Event|Advanced Mucosal Melanoma|Participants with advanced mucosal melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655146|NCT02180061|E1|Reported Event|Advanced Cutaneous Melanoma|Participants with advanced cutaneous melanoma received pembrolizumab, 2 mg/kg, IV over 30 minutes on Day 1 Q3W.
655147|NCT02179424|B5|Baseline|Total|Total of all reporting groups
655148|NCT02179424|B4|Baseline|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655149|NCT02179424|B3|Baseline|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655150|NCT02179424|B2|Baseline|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655151|NCT02179424|B1|Baseline|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655697|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
655152|NCT02179424|P4|Participant Flow|Phone Counseling + Booklet + SMS|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655153|NCT02179424|P3|Participant Flow|Phone Counseling + Health Talk + Booklet + SMS|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655154|NCT02179424|P2|Participant Flow|Face-to-face Counseling + Booklet + SMS|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655155|NCT02179424|P1|Participant Flow|Health Talk + Workshop + Booklet + SMS|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655156|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655157|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655158|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655159|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655160|NCT02179424|O4|Outcome|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655161|NCT02179424|O3|Outcome|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655162|NCT02179424|O2|Outcome|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655163|NCT02179424|O1|Outcome|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655164|NCT02179424|O1|Outcome|Employers' KAP|Employers' knowledge on smoking and quitting
655165|NCT02179424|E4|Reported Event|Group D|"Phone counseling (Motivational intervention) + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655166|NCT02179424|E3|Reported Event|Group C|"Phone counseling (Motivational intervention) + Health talk + booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655167|NCT02179424|E2|Reported Event|Group B|"Face to Face counseling (Motivational intervention) + Booklet + SMS~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655284|NCT02178540|O1|Outcome|Open Label|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
655168|NCT02179424|E1|Reported Event|Group A|"Health talk + workshop (Motivational intervention) + booklet + Short Message Service (SMS)~Motivational intervention: Use motivational interview strategies to provide smoking cessation intervention"
655169|NCT02179398|B3|Baseline|Total|Total of all reporting groups
655170|NCT02179398|B2|Baseline|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
655171|NCT02179398|B1|Baseline|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
655172|NCT02179398|P2|Participant Flow|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
655173|NCT02179398|P1|Participant Flow|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
655174|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
655175|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
655176|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
655177|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
655178|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
655179|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
655180|NCT02179398|O2|Outcome|Patients < 3 Months Old|Patients allocated to the Lab-score group OR to the control group, aged less than 3 months-old.
655181|NCT02179398|O1|Outcome|Patients 0-3 Years Old|Patients allocated to the Lab-score group OR to the control group, aged 0 up to 36 months-old.
655182|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
655183|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
655184|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
655185|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
655186|NCT02179398|O2|Outcome|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: white blood cell (WBC) count, band count and C-Reactive Protein (CRP) determination.~(Procalcitonin (PCT) and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
655187|NCT02179398|O1|Outcome|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(white blood cell (WBC) and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
655188|NCT02179398|E2|Reported Event|Control Group|"Patients assessed through the following classically admitted biomarkers for the detection of serious bacterial infection: WBC count, band count and CRP determination.~(PCT and thus Lab-score blinded to the physician in charge of the patient).~Allocation to the control group"
655189|NCT02179398|E1|Reported Event|Lab-score Group|"Patients assessed through the Lab-score determination only: Lab-score ≥3 used as the sole marker for the detection of serious bacterial infection.~(WBC and band counts blinded to the physician in charge of the patient)~Allocation to the Lab-score group"
655190|NCT02178995|B3|Baseline|Total|Total of all reporting groups
655191|NCT02178995|B2|Baseline|Healthy Controls|Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.
655192|NCT02178995|B1|Baseline|Participants With Epilepsy|"Participants received three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time. Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed."
655193|NCT02178995|P9|Participant Flow|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
655285|NCT02178540|E4|Reported Event|Open Label (>=18) Years Old|
655194|NCT02178995|P8|Participant Flow|20mg, 10mg, Then Placebo - Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655195|NCT02178995|P7|Participant Flow|20mg, Placebo, Then 10mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655196|NCT02178995|P6|Participant Flow|Placebo, 10mg, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655197|NCT02178995|P5|Participant Flow|Placebo, 20mg, Then 10mg (Double-blind|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655212|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655198|NCT02178995|P4|Participant Flow|10mg, Placebo, Then 20mg (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655199|NCT02178995|P3|Participant Flow|10mg, 20mg, Then Placebo (Double-blind)|"Participants received three single doses in randomized order of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and completed cognitive testing and neuropsychiatric questionnaires. This single-dose phase was followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy first received blinded, single-dose capsules which contained either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655200|NCT02178995|P2|Participant Flow|Healthy Controls|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655201|NCT02178995|P1|Participant Flow|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
655202|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655203|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655204|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
655205|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
655286|NCT02178540|E3|Reported Event|Open Label (11-17)Years Old|
655287|NCT02178540|E2|Reported Event|Total - All Participants|
655206|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655207|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655208|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655209|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655210|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655211|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655342|NCT02177032|O2|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655408|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655213|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655214|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
655215|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
655216|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
655217|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655218|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655219|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655220|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
655288|NCT02178540|E1|Reported Event|Open Label (6-10) Years Old|one dose (4 capsules) of matching placebo to Tobramycin inhalation powder hard capsule
655221|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
655222|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the SSC is specific to medication side effects, healthy controls did not complete the questionnaire.
655223|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655224|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the questionnaire is specific to epilepsy populations, and the side-effects to AEDs, healthy controls did not complete the QOLIE-89.
655225|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655253|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
656112|NCT02171195|B10|Baseline|Total|Total of all reporting groups
655226|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655227|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655228|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
655229|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
655230|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
655231|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655232|NCT02178995|O2|Outcome|Participants With Epilepsy (Double-blind Portion)|
655233|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655234|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655289|NCT02178059|B1|Baseline|Randomized Subjects|All randomized subjects
655290|NCT02178059|P2|Participant Flow|M2 First, Then M3|Sequence 2: M2 first, then M3
655235|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655236|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655237|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|Note: Because the QOLIE-89 is specific to epilepsy populations, most of its questions are not applicable to healthy controls, and therefore healthy controls did not complete the QOLIE-89.
655238|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655239|NCT02178995|O2|Outcome|Participants With Epilepsy (Open-label Portion)|
655254|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655240|NCT02178995|O1|Outcome|Participants With Epilepsy (Baseline)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:~Placebo 20mg of methylphenidate or 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655241|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655242|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655243|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
655244|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
655245|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655246|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655247|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
655248|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
655291|NCT02178059|P1|Participant Flow|M3 First, Then M2|Sequence 1: M3 first then M2
655292|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
655293|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
655294|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
655249|NCT02178995|O4|Outcome|Healthy Controls: Visit 5|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655250|NCT02178995|O3|Outcome|Healthy Controls: Visit 1 (Baseline)|"Healthy controls completed the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but were not exposed to study medication.~Healthy controls were included primarily for use in the open-label comparison. They did not receive blinded medication during the 'double-blind' portion and their data was not used in the 'double-blind' comparison. In order to control for test/re-test variables, they completed testing during the 'double-blind' portion, so that they completed testing an equivalent number of times to the epilepsy patients in the 'open-label' portion."
655251|NCT02178995|O2|Outcome|Participants With Epilepsy: Visit 5 (Open Label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After four weeks, their scores on the batteries and questionnaires were again assessed.
655252|NCT02178995|O1|Outcome|Participants With Epilepsy: Visit 1 (Baseline)|At visit 1, participants underwent neurocognitive batteries and neuropsychiatric questionnaires for baseline assessment. No medications were given at this visit.
655343|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen with HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655255|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655256|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655257|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655258|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655259|NCT02178995|O3|Outcome|Participants With Epilepsy: Methylphenidate 20 mg|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 20 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655260|NCT02178995|O2|Outcome|Participants With Epilepsy: Methylphenidate 10 mg Dose|"Participants received blinded, single-dose capsules of during visits 2, 3, and 4. During one of these visits, they received the methylphenidate 10 mg dose.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655261|NCT02178995|O1|Outcome|Participants With Epilepsy: Placebo|"Methylphenidate: Participants received blinded, single-dose capsules during either visit 2, 3, or 4. During one of these visits, they received the placebo capsule.~At each visit, they received one capsule and then completed the neurocognitive batteries and neuropsychiatric questionnaires. There was no medication administered between visits during this time."
655262|NCT02178995|E9|Reported Event|Healthy Controls|Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication. They are included as a control group for the open-label phase of the study (visit 1 vs visit 5) only.
655263|NCT02178995|E8|Reported Event|40mg, 20mg, Then Placebo (One Participant)|This study was originally intended to use 40mg, 20mg, and placebo doses rather than 20mg, 10mg, and placebo. This individual developed tachycardia (see adverse events) on the 40mg dose, and was withdrawn from the double-blind portion as a result. We removed the 40mg doses from this study and replaced them with 10mg doses. No other participant received a 40mg dose. This participant rejoined the open-label portion after consultation with his PCP due to significant perceived benefit from the MPH dose.
655295|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
655296|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
655297|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
655298|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
655299|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
669459|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
655264|NCT02178995|E7|Reported Event|20mg, Placebo, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~20mg of methylphenidate, Placebo, 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655265|NCT02178995|E6|Reported Event|20mg, 10mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~20mg of methylphenidate, 10mg of methylphenidate, Placebo.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655313|NCT02177201|E2|Reported Event|Group 2 Intravenous 20ml/kg/h 0.9 %Saline Solution|Group 2, intravenous 20 ml/kg/h 0.9% saline solution. After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
655344|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
656113|NCT02171195|B9|Baseline|Group 8 1200 mg|BIA 2-093 1200mg or placebo
655266|NCT02178995|E5|Reported Event|10mg, Placebo, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~10mg of methylphenidate, Placebo, 20mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655267|NCT02178995|E4|Reported Event|10mg, 20mg, Then Placebo (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~10mg of methylphenidate, 20mg of methylphenidate, Placebo.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655268|NCT02178995|E3|Reported Event|Placebo, 10mg, Then 20mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~Placebo, 10mg of methylphenidate, 20mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655269|NCT02178995|E2|Reported Event|Placebo, 20mg, Then 10mg (Double-blind)|"Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 10mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.~Methylphenidate: Participants with epilepsy will first receive blinded, single-dose capsules in the following order:~Placebo, 20mg of methylphenidate, 10mg of methylphenidate.~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
655270|NCT02178995|E1|Reported Event|Participants With Epilepsy (Open-label)|Following the final randomized visit, interested participants were prescribed 10mg of methylphenidate twice daily, increased to 20mg of methylphenidate twice daily as tolerated. After a four week treatment trial, their scores on the batteries and questionnaires were again assessed.
655271|NCT02178787|B3|Baseline|Total|Total of all reporting groups
655272|NCT02178787|B2|Baseline|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
655273|NCT02178787|B1|Baseline|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
655274|NCT02178787|P2|Participant Flow|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
655275|NCT02178787|P1|Participant Flow|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
655276|NCT02178787|O2|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, standing up.
655277|NCT02178787|O1|Outcome|Type 2 Diabetes Mellitus|Head-up tilt, vasoreactivity, standing up.
655278|NCT02178787|O2|Outcome|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
655279|NCT02178787|O1|Outcome|Type 2 Diabetics|Head-up tilt, vasoreactivity, sitting to standing-up
655280|NCT02178787|E2|Reported Event|Non-diabetic Controls|Head-up tilt, vasoreactivity, sitting to standing-up
655300|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
655301|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
655302|NCT02178059|O2|Outcome|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
655303|NCT02178059|O1|Outcome|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
655304|NCT02178059|E2|Reported Event|Bricanyl Turbuhaler M2|Bricanyl Turbuhaler M2: 0.5 mg terbutaline sulphate (metered dose) per inhalation
655305|NCT02178059|E1|Reported Event|Bricanyl Turbuhaler M3|Bricanyl Turbuhaler M3: 0.4 mg terbutaline sulphate (delivered dose) per inhalation
655306|NCT02177201|B3|Baseline|Total|Total of all reporting groups
655307|NCT02177201|B2|Baseline|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
655308|NCT02177201|B1|Baseline|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
655309|NCT02177201|P2|Participant Flow|Group 2|Intravenous 20 ml/kg/h 0.9% saline solution
655310|NCT02177201|P1|Participant Flow|Group 1|Intravenous 10 ml/kg/h 0.9% saline solution
655311|NCT02177201|O2|Outcome|20 ml/kg/h 0.9% Saline Solution|"Group 2, intravenous 20 ml/kg/h 0.9% saline solution~0.9 saline solution : After induction , IV access was established and children were randomly allocated to receive: 20 ml/kg/h 0.9% saline solution during intraoperatively"
655312|NCT02177201|O1|Outcome|10 ml/kg/h 0.9 %Saline Solution|"Group 1, intravenous 10 ml/kg/h 0.9% saline solution ,~0.9 % saline solution: After induction, IV access was established and children were randomly allocated to receive Group 1, 10 ml/kg/h 0.9% saline solution ;"
655314|NCT02177201|E1|Reported Event|Group 1 Intravenous 10ml/kg/h 0.9 %Saline Solution|Group 1, intravenous 10 ml/kg/h 0.9% saline solution , After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 ml/kg/h 0.9% saline solution ; Group 2, 20 ml/kg/h 0.9% saline solution by intravenous during intraoperatively. In both groups no adverse events were observed.
655315|NCT02177032|B5|Baseline|Total|Total of all reporting groups
655316|NCT02177032|B4|Baseline|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
655317|NCT02177032|B3|Baseline|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
655318|NCT02177032|B2|Baseline|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655319|NCT02177032|B1|Baseline|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655320|NCT02177032|P4|Participant Flow|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
655321|NCT02177032|P3|Participant Flow|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen
655322|NCT02177032|P2|Participant Flow|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
655323|NCT02177032|P1|Participant Flow|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655324|NCT02177032|O2|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
655325|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655326|NCT02177032|O2|Outcome|2-sites TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
655327|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655328|NCT02177032|O4|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
655329|NCT02177032|O3|Outcome|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen
655330|NCT02177032|O2|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655331|NCT02177032|O1|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655390|NCT02176525|P4|Participant Flow|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655332|NCT02177032|O4|Outcome|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
655333|NCT02177032|O3|Outcome|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
655334|NCT02177032|O2|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655335|NCT02177032|O1|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655336|NCT02177032|O2|Outcome|2-sites, TRC Without HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
655337|NCT02177032|O1|Outcome|4-sites, 1-week Without HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655338|NCT02177032|O2|Outcome|2-sites, TRC Without HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
655339|NCT02177032|O1|Outcome|4-sites, 1-week Without HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655340|NCT02177032|O2|Outcome|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655341|NCT02177032|O1|Outcome|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655345|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
655346|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
655347|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
655348|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
655349|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8) with or without HRIG administration on day 1
655350|NCT02177032|O2|Outcome|TOTAL 2-sites, TRC|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen, with or without HRIG administered on day 1
655351|NCT02177032|O1|Outcome|TOTAL 4-sites, 1-week|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen with and without HRIG administered on day 1
655352|NCT02177032|E4|Reported Event|2-sites, TRC WITH HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the “2-sites, TRC”, updated Thai Red Cross regimen. HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly
655353|NCT02177032|E3|Reported Event|2-sites, TRC WITHOUT HRIG|8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the “2-sites, TRC”, updated Thai Red Cross regimen.
655354|NCT02177032|E2|Reported Event|4-sites, 1-week WITH HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the “4-sites, 1-week” regimen HRIG administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight
655355|NCT02177032|E1|Reported Event|4-sites, 1-week WITHOUT HRIG|12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the “4-sites, 1-week” regimen
655356|NCT02176655|B1|Baseline|Cross-Over Group|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
655357|NCT02176655|P1|Participant Flow|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
655358|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
655391|NCT02176525|P3|Participant Flow|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655359|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655360|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655361|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655362|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655363|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
655364|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655365|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655366|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
655367|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655368|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
655369|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655371|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655372|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
655373|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655374|NCT02176655|O2|Outcome|Placebo|"One placebo capsule to match taken after the onset of a delayed alcohol induced headache.~Placebo"
655375|NCT02176655|O1|Outcome|VVD-101|"One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule taken after the onset of a delayed alcohol induced headache.~Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order."
655376|NCT02176655|E1|Reported Event|All Study Participants|"Sumatriptan succinate 12.5 mg/acetylsalicylic acid 325 mg: All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.~One sumatriptan succinate 12.5 mg combined with acetylsalicylic acid 325 mg (VVD-101) capsule or one placebo capsule to be taken after the onset of a delayed alcohol induced headache."
655377|NCT02176525|B9|Baseline|Total|Total of all reporting groups
655378|NCT02176525|B8|Baseline|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655379|NCT02176525|B7|Baseline|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655380|NCT02176525|B6|Baseline|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655381|NCT02176525|B5|Baseline|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655382|NCT02176525|B4|Baseline|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655383|NCT02176525|B3|Baseline|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655384|NCT02176525|B2|Baseline|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655385|NCT02176525|B1|Baseline|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655386|NCT02176525|P8|Participant Flow|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655387|NCT02176525|P7|Participant Flow|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655388|NCT02176525|P6|Participant Flow|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655389|NCT02176525|P5|Participant Flow|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655392|NCT02176525|P2|Participant Flow|DBV 100mg Fibrosis|Deleobuvir (DBV) 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655393|NCT02176525|P1|Participant Flow|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655394|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655395|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655396|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655397|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
655398|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655399|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655400|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655401|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655402|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655403|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655404|NCT02176525|O4|Outcome|DBV 400mg|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days. Subgroup of patients in fibrosis and in cirrhosis presented in one arm.
655405|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655406|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655407|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655701|NCT02175199|E2|Reported Event|AIR OPTIX COLORS|Includes all eyes exposed to AIR OPTIX® COLORS contact lenses
655409|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655410|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655411|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655412|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655413|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655414|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655415|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655416|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655417|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655418|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655419|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655420|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655421|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655422|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655423|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655424|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655425|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655426|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655427|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655428|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655429|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655430|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655431|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655432|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655433|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655434|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655435|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655436|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655437|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655438|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655439|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655440|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655441|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655442|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655443|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655444|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655445|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655446|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655702|NCT02175199|E1|Reported Event|Pre-treatment|Includes all subjects prior to the exposure to the investigational or control products
655447|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655448|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655449|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655450|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655451|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655452|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655453|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655454|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655455|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655456|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655457|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655458|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655459|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655460|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655461|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655462|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655463|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655464|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655465|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655466|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655467|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
656425|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
655468|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655469|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655470|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655471|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655472|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655473|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655474|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655475|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655476|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655477|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655478|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655479|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655480|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655481|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655482|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655483|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655484|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655485|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655486|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655487|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655488|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655489|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655490|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655491|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655492|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655493|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655494|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655495|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655496|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655497|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655498|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655499|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655500|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655501|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655502|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655503|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655504|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655505|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
656426|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
655506|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655507|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655508|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655509|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655510|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655511|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655512|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655513|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655514|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655515|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655516|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655517|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655518|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655519|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655520|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655521|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655522|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655523|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655524|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655525|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655526|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655527|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655528|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655529|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655530|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655531|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655532|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655533|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655534|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655535|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655536|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655537|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655538|NCT02176525|O7|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655539|NCT02176525|O6|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655540|NCT02176525|O5|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655541|NCT02176525|O4|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655542|NCT02176525|O3|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655543|NCT02176525|O2|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
672214|NCT02036840|O1|Outcome|Penicillin Allergy|Antibiotic
655544|NCT02176525|O1|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655545|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655546|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655547|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655548|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655549|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655550|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655551|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655552|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655553|NCT02176525|O8|Outcome|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655554|NCT02176525|O7|Outcome|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655555|NCT02176525|O6|Outcome|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655556|NCT02176525|O5|Outcome|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655557|NCT02176525|O4|Outcome|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655558|NCT02176525|O3|Outcome|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655559|NCT02176525|O2|Outcome|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655560|NCT02176525|O1|Outcome|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655561|NCT02176525|E8|Reported Event|DBV 1200mg Fibrosis|DBV 1200mg (as tablet, 6x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655562|NCT02176525|E7|Reported Event|DBV 800mg Fibrosis|DBV 800mg (as tablet, 4x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655563|NCT02176525|E6|Reported Event|DBV 600mg Cirrhosis|DBV 600mg (as tablet, 3x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655564|NCT02176525|E5|Reported Event|DBV 400mg Cirrhosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with cirrhosis
655565|NCT02176525|E4|Reported Event|DBV 400mg Fibrosis|DBV 400mg (as tablet, 2x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655566|NCT02176525|E3|Reported Event|DBV 200mg Fibrosis|DBV 200mg (as tablet, 1x 200mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655567|NCT02176525|E2|Reported Event|DBV 100mg Fibrosis|DBV 100mg (as tablet, 2x 50mg, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655568|NCT02176525|E1|Reported Event|Placebo Fibrosis|Placebo (as tablet, oral) administered 3 times (every 8 hours) daily after a meal for 5 days in patients with fibrosis
655569|NCT02176421|B1|Baseline|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655570|NCT02176421|P1|Participant Flow|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655571|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655572|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655573|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655574|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655575|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655576|NCT02176421|O1|Outcome|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655577|NCT02176421|E1|Reported Event|VOLBELLA® With Lidocaine|Infra-orbital skin depressions injected with VOLBELLA® with lidocaine.
655578|NCT02176356|B1|Baseline|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655579|NCT02176356|P1|Participant Flow|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655671|NCT02175745|O1|Outcome|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
655580|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655581|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655582|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655583|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655584|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655585|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655698|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
655586|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655587|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655588|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655589|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655590|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655591|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655592|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655593|NCT02176356|O1|Outcome|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655726|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655594|NCT02176356|E1|Reported Event|All Participants|JUVÉDERM® ULTRA XC and/or JUVÉDERM® ULTRA PLUS XC and/or JUVÉDERM® VOLUMA® XC injection into facial areas, volume as determined by the investigator on Day 1 with additional treatment at Day 14 if applicable. LATISSE® 1 drop applied to upper eyelid at the base of the eyelashes once daily in the evening for 17 weeks beginning on Day 1. BOTOX® Cosmetic 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas at Month 3.
655595|NCT02175771|B9|Baseline|Total|Total of all reporting groups
655596|NCT02175771|B8|Baseline|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655597|NCT02175771|B7|Baseline|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655598|NCT02175771|B6|Baseline|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655599|NCT02175771|B5|Baseline|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655600|NCT02175771|B4|Baseline|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655601|NCT02175771|B3|Baseline|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655602|NCT02175771|B2|Baseline|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655603|NCT02175771|B1|Baseline|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655604|NCT02175771|P9|Participant Flow|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655605|NCT02175771|P8|Participant Flow|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655606|NCT02175771|P7|Participant Flow|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655607|NCT02175771|P6|Participant Flow|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655608|NCT02175771|P5|Participant Flow|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655609|NCT02175771|P4|Participant Flow|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655610|NCT02175771|P3|Participant Flow|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655611|NCT02175771|P2|Participant Flow|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655612|NCT02175771|P1|Participant Flow|Enrolled Patients|During the run-in period, patients continued using their current asthma medications (ie, inhaled corticosteroid and/or other controller therapies) except for their short acting beta2-agonist (SABA), which was replaced by the sponsor-provided study rescue medication.
655613|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655614|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655615|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655699|NCT02175199|O1|Outcome|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
655700|NCT02175199|E3|Reported Event|FreshLook COLORBLENDS|Includes all eyes exposed to FreshLook® COLORBLENDS® contact lenses
655616|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655617|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655618|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655619|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655620|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655621|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655622|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655623|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655624|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655672|NCT02175745|O1|Outcome|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
672215|NCT02036840|E1|Reported Event|Penicillin Allergy|Antibiotic
655625|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655626|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655627|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655628|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655629|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655659|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655630|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655631|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655632|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655633|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655634|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655635|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655636|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655637|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655638|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655639|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655673|NCT02175745|E1|Reported Event|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
655640|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655641|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655642|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655643|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655644|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655645|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655646|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655647|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655648|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655649|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655650|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655651|NCT02175771|O2|Outcome|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655652|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655653|NCT02175771|O8|Outcome|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655654|NCT02175771|O7|Outcome|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655674|NCT02175212|B3|Baseline|Total|Total of all reporting groups
655727|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655655|NCT02175771|O6|Outcome|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655656|NCT02175771|O5|Outcome|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655657|NCT02175771|O4|Outcome|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655658|NCT02175771|O3|Outcome|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655694|NCT02175199|P2|Participant Flow|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
655695|NCT02175199|P1|Participant Flow|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
655660|NCT02175771|O1|Outcome|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655661|NCT02175771|E8|Reported Event|Fp MDPI 200 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg Fp for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655662|NCT02175771|E7|Reported Event|Fp MDPI 100 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg Fp for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655663|NCT02175771|E6|Reported Event|FS MDPI 200/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 200/12.5 mcg for a total daily dose of 400/25 mcg FS for 26 weeks. This was the high-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655664|NCT02175771|E5|Reported Event|FS MDPI 100/12.5 mcg|"Participants took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate/salmeterol (FS) 100/12.5 mcg for a total daily dose of 200/25 mcg FS for 26 weeks. This was the mid-strength experimental intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655665|NCT02175771|E4|Reported Event|FLOVENT HFA 220 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 880 mcg Fp for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655666|NCT02175771|E3|Reported Event|FLOVENT HFA 110 mcg|"Participants took 2 inhalations using a hydrofluoroalkane (HFA) inhaler twice a day of fluticasone propionate (Fp) for a total daily dose of 440 mcg Fp for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid (ICS) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655667|NCT02175771|E2|Reported Event|ADVAIR DISKUS 500/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 500/50 mcg for a total daily dose of 1000/100 mcg FS for 26 weeks. This was the high-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655668|NCT02175771|E1|Reported Event|ADVAIR DISKUS 250/50 mcg|"Participants took 1 inhalation of a dry-powder formulation twice a day of fluticasone propionate/salmeterol (FS) 250/50 mcg for a total daily dose of 500/100 mcg FS for 26 weeks. This was the mid-strength active comparator intervention in the inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA) cohort.~Albuterol/salbutamol HFA metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
655669|NCT02175745|B1|Baseline|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
655670|NCT02175745|P1|Participant Flow|Diagnostic (FDOPA-PET/CT or PET/MRI)|Patients receive 18F-FDOPA intravenously (IV) and then undergo PET/CT or PET/MRI 10-30 minutes later. After completion of study, patients are followed up at 24 hours and at 1 week.
655723|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655675|NCT02175212|B2|Baseline|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655676|NCT02175212|B1|Baseline|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655677|NCT02175212|P2|Participant Flow|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655678|NCT02175212|P1|Participant Flow|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655696|NCT02175199|O2|Outcome|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
655679|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655680|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655681|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655682|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655683|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655684|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655685|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655686|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655687|NCT02175212|O2|Outcome|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655724|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655725|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655688|NCT02175212|O1|Outcome|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655689|NCT02175212|E2|Reported Event|Short Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Short term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~- Bicalutamide 50 mg tablet every day for 2 months~Short term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655690|NCT02175212|E1|Reported Event|Long Term Androgen Deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~High dose conformal radiotherapy~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: - Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)~Bicalutamide 50 mg tablet every day for 2 months~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy~Long term androgen deprivation: Minimum dose of 76 Gy (range 76–82 Gy)"
655691|NCT02175199|B3|Baseline|Total|Total of all reporting groups
655692|NCT02175199|B2|Baseline|FreshLook COLORBLENDS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days with a 2-week replacement.
655693|NCT02175199|B1|Baseline|AIR OPTIX COLORS|Contact lenses with color printing worn bilaterally in a daily wear modality 5 days/week, 8 hours/day for 30 days.
655704|NCT02175121|B5|Baseline|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655705|NCT02175121|B4|Baseline|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655706|NCT02175121|B3|Baseline|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655707|NCT02175121|B2|Baseline|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655708|NCT02175121|B1|Baseline|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655709|NCT02175121|P5|Participant Flow|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655710|NCT02175121|P4|Participant Flow|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655711|NCT02175121|P3|Participant Flow|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655712|NCT02175121|P2|Participant Flow|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655713|NCT02175121|P1|Participant Flow|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655714|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655715|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655716|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655717|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655718|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655719|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655720|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655721|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655722|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655728|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655729|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655730|NCT02175121|O4|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655731|NCT02175121|O3|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655732|NCT02175121|O2|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655733|NCT02175121|O1|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655734|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655735|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655736|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655737|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655738|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655739|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655740|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655741|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655742|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655743|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655744|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655745|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655746|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655747|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655748|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655749|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655750|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655751|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655752|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655753|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655754|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655755|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655756|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655757|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655758|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655759|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655760|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655761|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655762|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655763|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655764|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655765|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655766|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655767|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
656080|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
655768|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655769|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655770|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655771|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655772|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655773|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655774|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655775|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655776|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655777|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655778|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655779|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655780|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655781|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655782|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655783|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655784|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655785|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655786|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655787|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655788|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655789|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655790|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655791|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655792|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655793|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655794|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655795|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655796|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655797|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655798|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655799|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655800|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655801|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655802|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655803|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655804|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655805|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655806|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655807|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655808|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655809|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655810|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655811|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655812|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655813|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655814|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655815|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655816|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655817|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655818|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655819|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655820|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655821|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655822|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655823|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655824|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655825|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655826|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655827|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655828|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655899|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
655829|NCT02175121|O5|Outcome|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655830|NCT02175121|O4|Outcome|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655831|NCT02175121|O3|Outcome|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655832|NCT02175121|O2|Outcome|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655833|NCT02175121|O1|Outcome|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655834|NCT02175121|E5|Reported Event|PF-06291874 150 mg|Participants received PF-06291874 150 mg (two 25 mg tablets, one 100 mg tablet and one 5/25 mg placebo tablet) once daily for 28 days
655835|NCT02175121|E4|Reported Event|PF-06291874 75 mg|Participants received PF-06291874 75 mg (three 25 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655836|NCT02175121|E3|Reported Event|PF-06291874 35 mg|Participants received PF-06291874 35 mg (two 5 mg tablets, one 25 mg tablet and one 100 mg placebo tablet) once daily for 28 days
655837|NCT02175121|E2|Reported Event|PF-06291874 15 mg|Participants received PF-06291874 15 mg (three 5 mg tablets and one 100 mg placebo tablet) once daily for 28 days
655838|NCT02175121|E1|Reported Event|Placebo|Participants received placebo (three 5/25 milligram [mg] and one 100 mg matching placebo tablets) once daily for 28 days
655839|NCT02173769|B1|Baseline|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655840|NCT02173769|P1|Participant Flow|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655841|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655842|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655843|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655844|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655845|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655846|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655847|NCT02173769|O1|Outcome|All Patients|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat or Spiriva 18 microgram plus Striverdi Respimat
655848|NCT02173769|E2|Reported Event|Spiriva 18 mcg + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva 18 microgram plus Striverdi Respimat
655849|NCT02173769|E1|Reported Event|Spiriva Respimat + Striverdi Respimat|Patients with moderate to severe chronic obstructive pulmonary disease (COPD) and treated with Spiriva Respimat plus Striverdi Respimat
655850|NCT02173535|B21|Baseline|Total|Total of all reporting groups
655851|NCT02173535|B20|Baseline|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655852|NCT02173535|B19|Baseline|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655853|NCT02173535|B18|Baseline|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655854|NCT02173535|B17|Baseline|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655855|NCT02173535|B16|Baseline|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655856|NCT02173535|B15|Baseline|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655857|NCT02173535|B14|Baseline|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655858|NCT02173535|B13|Baseline|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655859|NCT02173535|B12|Baseline|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655860|NCT02173535|B11|Baseline|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655861|NCT02173535|B10|Baseline|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655862|NCT02173535|B9|Baseline|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655863|NCT02173535|B8|Baseline|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655864|NCT02173535|B7|Baseline|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655865|NCT02173535|B6|Baseline|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655866|NCT02173535|B5|Baseline|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655867|NCT02173535|B4|Baseline|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655868|NCT02173535|B3|Baseline|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655869|NCT02173535|B2|Baseline|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655870|NCT02173535|B1|Baseline|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655871|NCT02173535|P20|Participant Flow|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655872|NCT02173535|P19|Participant Flow|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655873|NCT02173535|P18|Participant Flow|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655874|NCT02173535|P17|Participant Flow|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655875|NCT02173535|P16|Participant Flow|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655876|NCT02173535|P15|Participant Flow|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655877|NCT02173535|P14|Participant Flow|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655878|NCT02173535|P13|Participant Flow|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655879|NCT02173535|P12|Participant Flow|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
656427|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
655880|NCT02173535|P11|Participant Flow|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655881|NCT02173535|P10|Participant Flow|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655882|NCT02173535|P9|Participant Flow|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655883|NCT02173535|P8|Participant Flow|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655884|NCT02173535|P7|Participant Flow|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655885|NCT02173535|P6|Participant Flow|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655886|NCT02173535|P5|Participant Flow|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655887|NCT02173535|P4|Participant Flow|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655888|NCT02173535|P3|Participant Flow|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655889|NCT02173535|P2|Participant Flow|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655890|NCT02173535|P1|Participant Flow|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655891|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
655892|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
655893|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
655894|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
655895|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
655896|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
655897|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
655898|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
655900|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
655901|NCT02173535|O5|Outcome|VC- Etafilcon A|Subjects that wore the VC investigational lens during any of the 5 period of the study.
655902|NCT02173535|O4|Outcome|LA-etafilcon A|Subjects that wore the LA investigational lens during any of the 5 period of the study.
655903|NCT02173535|O3|Outcome|JG-etafilcon A|Subjects that wore the JG investigational lens during any of the 5 period of the study.
655904|NCT02173535|O2|Outcome|CS- Etafilcon A|Subjects that wore the CS investigational lens during any of the 5 period of the study.
655905|NCT02173535|O1|Outcome|AP- Etafilcon A|Subjects that wore the AP investigational lens during any of the 5 period of the study.
655906|NCT02173535|E20|Reported Event|VC-LA-AP-JG-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655907|NCT02173535|E19|Reported Event|VC-JG-LA-CS-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655908|NCT02173535|E18|Reported Event|VC-CS-JG-AP-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655909|NCT02173535|E17|Reported Event|VC-AP-CS-LA-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655910|NCT02173535|E16|Reported Event|LA-VC-CS-JG-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655911|NCT02173535|E15|Reported Event|LA-JG-VC-AP-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655912|NCT02173535|E14|Reported Event|LA-CS-AP-VC-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655913|NCT02173535|E13|Reported Event|LA-AP-JG-CS-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655914|NCT02173535|E12|Reported Event|JG-VC-AP-CS-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655915|NCT02173535|E11|Reported Event|JG-LA-CS-AP-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655916|NCT02173535|E10|Reported Event|JG-CS-VC-LA-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
656428|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
655917|NCT02173535|E9|Reported Event|JG-AP-LA-VC-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655918|NCT02173535|E8|Reported Event|CS-LA-JG-VC-AP|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655919|NCT02173535|E7|Reported Event|CS-VC-LA-AP-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655920|NCT02173535|E6|Reported Event|CS-JG-AP-LA-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655921|NCT02173535|E5|Reported Event|CS-AP-VC-JG-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655922|NCT02173535|E4|Reported Event|AP-VC-JG-LA-CS|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655923|NCT02173535|E3|Reported Event|AP-LA-VC-CS-JG|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655924|NCT02173535|E2|Reported Event|AP-JG-CS-VC-LA|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655925|NCT02173535|E1|Reported Event|AP-CS-LA-JG-VC|All lenses used in this study were etafilcon A. The lens title correspond to the lens name listed in the protocol registration and refers to various lens variants
655926|NCT02173054|B4|Baseline|Total|Total of all reporting groups
655927|NCT02173054|B3|Baseline|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655928|NCT02173054|B2|Baseline|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655929|NCT02173054|B1|Baseline|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655930|NCT02173054|P3|Participant Flow|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
656114|NCT02171195|B8|Baseline|Group 7 900 mg|BIA 2-093 900mg or placebo
655931|NCT02173054|P2|Participant Flow|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655932|NCT02173054|P1|Participant Flow|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655933|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655934|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655935|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655936|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655937|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655938|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655939|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
673287|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
655940|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655941|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655942|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655943|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655944|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655945|NCT02173054|O3|Outcome|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655946|NCT02173054|O2|Outcome|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655947|NCT02173054|O1|Outcome|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655948|NCT02173054|E3|Reported Event|Adapalene Gel With Eucerin|"Morning~Wash face by prepared facial foam and dry their face~Apply Eucerin cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply Eucerin cream all over the face~Adapalene gel with Eucerin: Eucerin: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655992|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
655949|NCT02173054|E2|Reported Event|Adapalene Gel With Placebo Moisturizer|"Morning~Wash face by prepared facial foam and dry their face~Apply placebo cream all over the face~Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Apply placebo cream all over the face~Adapalene gel with placebo moisturizer: Placebo: 2 fingertip unit to cover all over the face twice a day.~Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655950|NCT02173054|E1|Reported Event|Adapalene Gel|"Evening~Wash face by prepared facial foam and dry your face~Apply adapalene gel all over the face~Adapalene gel: Adapalene gel: 2 fingertip unit to cover all over the face before going to bed"
655951|NCT02172755|B3|Baseline|Total|Total of all reporting groups
655952|NCT02172755|B2|Baseline|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655953|NCT02172755|B1|Baseline|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655954|NCT02172755|P2|Participant Flow|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655955|NCT02172755|P1|Participant Flow|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655956|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655957|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655958|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655959|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655960|NCT02172755|O2|Outcome|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655961|NCT02172755|O1|Outcome|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655962|NCT02172755|E2|Reported Event|Young Subjects|"16 young subjects aged between 18 and 40 years During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655963|NCT02172755|E1|Reported Event|Elderly Subjects|"14 Elderly subjects aged 65 years or more; During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.~BIA 2-093: During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose."
655964|NCT02172742|B3|Baseline|Total|Total of all reporting groups
655965|NCT02172742|B2|Baseline|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
656110|NCT02171234|E2|Reported Event|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
656111|NCT02171234|E1|Reported Event|Placebo|PLC, Placebo
655966|NCT02172742|B1|Baseline|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
655967|NCT02172742|P2|Participant Flow|Placebo + BIA 2-093|"Period 1:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
655968|NCT02172742|P1|Participant Flow|BIA 2-093 + Placebo|"Period 1:~BIA 2-093 1200 mg with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin~Period 2:~Placebo with:~Days 1 and 2: once-daily 0.50 mg digoxin Days 3 to 8: once-daily 0.25 mg odigoxin"
655969|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
655970|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
655971|NCT02172742|O1|Outcome|BIA 2-093 + Placebo|"Both Groups:~Period 1: BIA 2-093; Period 2: Placebo Period 1: Placebo; Period 2: BIA 2-093"
655972|NCT02172742|E2|Reported Event|Placebo+Digoxin|Placebo + Digoxin
655973|NCT02172742|E1|Reported Event|BIA 2-093+Digoxin|BIA 2-093 + Digoxin
655974|NCT02172625|B3|Baseline|Total|Total of all reporting groups
655975|NCT02172625|B2|Baseline|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
655976|NCT02172625|B1|Baseline|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
655977|NCT02172625|P2|Participant Flow|Protandim Dietary Supplement|"Each subject will ingest 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
655978|NCT02172625|P1|Participant Flow|Sugar Pill|"Corn starch and food coloring is the placebo comparator. Each subject will ingest 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
656429|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
655979|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
655980|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
655981|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
655982|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
655983|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
655984|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
655985|NCT02172625|O2|Outcome|Protandim Group|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
655986|NCT02172625|O1|Outcome|Placebo Group|"Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator~Protandim Dietary Supplement: This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given either 675 mg per day (1 pill per day) of Protandim for 90 days, or a 675 mg per day (1 pill per day) placebo (sugar pill). Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation."
655987|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
655988|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
655989|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contained 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
655990|NCT02172625|O1|Outcome|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
655991|NCT02172625|O2|Outcome|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacopa extract 150 mg, milk thistle 225mg, ashwagandha 150 mg, green tea 75 mg, turmeric 75 mg).
655993|NCT02172625|E2|Reported Event|Protandim Dietary Supplement|Each subject ingested 675 mg per day (1 pill) of Protandim for about 90 days. Each pill contains 5 botanicals (Bacoba extract 150 mg, milk thistle 225mg, ashwaganda 150 mg, green tea 75 mg, turmeric 75 mg).
655994|NCT02172625|E1|Reported Event|Sugar Pill|Corn starch and food coloring is the placebo comparator. Each subject ingested 675 mg (1 pill) per day of the placebo comparator
655995|NCT02171611|B1|Baseline|Overall|This study is open-label, single dose, randomised, three-way crossover design having 3 treatment periods ie., Dabigatran etexilate 150 mg formulation capsule: Reference (A), Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) and Dabigatran etexilate 150 mg formulation powder: Test 2 (C)
655996|NCT02171611|P6|Participant Flow|C/B/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in Period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.~Treatments were separated by washout period of at least 7 days after drug administration."
655997|NCT02171611|P5|Participant Flow|C/A/B|Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject. Treatments were separated by washout period of at least 7 days after drug administration.
655998|NCT02171611|P4|Participant Flow|B/C/A|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in period 3 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water.~Treatments were separated by washout period of at least 7 days after drug administration."
655999|NCT02171611|P3|Participant Flow|B/A/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject and in period 2 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water, followed in Period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.~Treatments were separated by washout period of at least 7 days after drug administration."
656000|NCT02171611|P2|Participant Flow|A/C/B|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in period 2 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution, followed in Period 3 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject.~Treatments were separated by washout period of at least 7 days after drug administration."
656430|NCT02169479|E4|Reported Event|Placebo|Placebo, PLC
656431|NCT02169479|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656001|NCT02171611|P1|Participant Flow|A/B/C|"Subjects were treated after an overnight fast of at least 10 hours with single oral dose, started in Period 1 with Dabigatran etexilate 150 mg capsule: Reference (A) with about 240 mL of water and in Period 2 with Dabigatran etexilate 150 mg pellets: Test 1 (B) by sprinkling the pellets on a teaspoon of food and administered immediately to the subject, followed in period 3 with Dabigatran etexilate 150 mg powder: Test 2 (C) resolved in 24 mL reconstitution solution.~Treatments were separated by washout period of at least 7 days after drug administration."
656002|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656003|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656004|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656005|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656006|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656007|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656008|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656009|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656010|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656011|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656012|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656013|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656014|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656015|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656016|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656017|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656018|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656019|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656020|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656021|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656022|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656023|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656024|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656025|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656026|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656027|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656028|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656029|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656030|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656031|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656032|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656033|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656034|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656035|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656036|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656037|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656038|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656039|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656040|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656041|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656042|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656043|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656044|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656045|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656046|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656047|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656048|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656049|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656050|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656051|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656052|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656053|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656054|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656055|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656056|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656057|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656058|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656059|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656060|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656061|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656062|NCT02171611|O3|Outcome|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656063|NCT02171611|O2|Outcome|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656064|NCT02171611|O1|Outcome|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656065|NCT02171611|E3|Reported Event|Dabigatran Etexilate 150 mg Powder: Test 2 (C)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation powder: Test 2 (C) resolved in 24 mL reconstitution solution after an overnight fast of at least 10 hours.
656066|NCT02171611|E2|Reported Event|Dabigatran Etexilate 150 mg Pellets: Test 1 (B)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation pellets: Test 1 (B) after an overnight fast of at least 10 hours. Pellets were sprinkled on a teaspoon of food and administered immediately to the subject.
656067|NCT02171611|E1|Reported Event|Dabigatran Etexilate 150 mg Capsule: Reference (A)|Subjects were treated with single oral dose of Dabigatran etexilate 150 mg formulation capsule: Reference (A) after an overnight fast of at least 10 hours with about 240 milliliter (mL) of water.
656068|NCT02171247|B3|Baseline|Total|Total of all reporting groups
656069|NCT02171247|B2|Baseline|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
656070|NCT02171247|B1|Baseline|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
656071|NCT02171247|P2|Participant Flow|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
656072|NCT02171247|P1|Participant Flow|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
656073|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
656074|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
656075|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
656076|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
656077|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
656078|NCT02171247|O1|Outcome|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
656079|NCT02171247|O2|Outcome|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
656081|NCT02171247|E2|Reported Event|Isovue 370|"Isovue 370 is a contrast agent with increased iodine concentration.~Isovue 370: Isovue 370 is a contrast agent with increased iodine concentration."
656082|NCT02171247|E1|Reported Event|Visipaque 320|"Standard protocol is Visipaque 320.~Visipaque 320: Visipaque 320 is standard protocol."
656083|NCT02171234|B6|Baseline|Total|Total of all reporting groups
656084|NCT02171234|B5|Baseline|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
656085|NCT02171234|B4|Baseline|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
656086|NCT02171234|B3|Baseline|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
656087|NCT02171234|B2|Baseline|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
656088|NCT02171234|B1|Baseline|Placebo|PLC, Placebo
656089|NCT02171234|P5|Participant Flow|Group 4 - 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 1200mg
656090|NCT02171234|P4|Participant Flow|Group 3 - 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 800mg
656091|NCT02171234|P3|Participant Flow|Group 2 - 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine 400mg
656092|NCT02171234|P2|Participant Flow|Group 1 - 200 mg b.i.d.|BIA 2-093 200mg (twice daily)
656093|NCT02171234|P1|Participant Flow|Placebo|PLC, Placebo
656094|NCT02171234|O5|Outcome|Placebo|PLC, Placebo
656095|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
656096|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
656097|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
656098|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
656099|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
656100|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
656101|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
656102|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
656103|NCT02171234|O4|Outcome|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
656104|NCT02171234|O3|Outcome|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
656105|NCT02171234|O2|Outcome|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
656106|NCT02171234|O1|Outcome|Group 1 - BIA 2-093 200 mg b.i.d.|BIA 2-093, ESL, Eslicarbazepine acetate 200mg (twice daily)
656107|NCT02171234|E5|Reported Event|Group 4 - BIA 2-093 1200 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 1200mg
656108|NCT02171234|E4|Reported Event|Group 3 - BIA 2-093 800 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 800mg
656109|NCT02171234|E3|Reported Event|Group 2 - BIA 2-093 400 mg o.d.|BIA 2-093, ESL, Eslicarbazepine acetate 400mg
656115|NCT02171195|B7|Baseline|Group 6 600 mg|BIA 2-093 600mg or placebo
656116|NCT02171195|B6|Baseline|Group 5 400 mg|BIA 2-093 or 400mg or placebo
656117|NCT02171195|B5|Baseline|Group 4 200 mg|BIA 2-093 200mg or placebo
656118|NCT02171195|B4|Baseline|Group 3 100 mg|BIA 2-093 100mg or placebo
656119|NCT02171195|B3|Baseline|Group 2 50 mg|BIA 2-093 50mg or placebo
656120|NCT02171195|B2|Baseline|Group 1 20 mg|BIA 2-093 20mg or placebo.
656121|NCT02171195|B1|Baseline|Placebo|Placebo, PLC
656122|NCT02171195|P9|Participant Flow|Group 8 1200 mg|BIA 2-093 1200mg or placebo
656123|NCT02171195|P8|Participant Flow|Group 7 900 mg|BIA 2-093 900mg or placebo
656124|NCT02171195|P7|Participant Flow|Group 6 600 mg|BIA 2-093 600mg or placebo
656125|NCT02171195|P6|Participant Flow|Group 5 400 mg|BIA 2-093 or 400mg or placebo
656126|NCT02171195|P5|Participant Flow|Group 4 200 mg|BIA 2-093 200mg or placebo
656127|NCT02171195|P4|Participant Flow|Group 3 100 mg|BIA 2-093 100mg or placebo
656128|NCT02171195|P3|Participant Flow|Group 2 50 mg|BIA 2-093 50mg or placebo
656129|NCT02171195|P2|Participant Flow|Group 1 20 mg|BIA 2-093 20mg or placebo.
656130|NCT02171195|P1|Participant Flow|Placebo|Placebo, PLC
656131|NCT02171195|O9|Outcome|Group 8 1200 mg|BIA 2-093 1200mg or placebo
656132|NCT02171195|O8|Outcome|Group 7 900 mg|BIA 2-093 900mg or placebo
656133|NCT02171195|O7|Outcome|Group 6 600 mg|BIA 2-093 600mg or placebo
656134|NCT02171195|O6|Outcome|Group 5 400 mg|BIA 2-093 or 400mg or placebo
656135|NCT02171195|O5|Outcome|Group 4 200 mg|BIA 2-093 200mg or placebo
656136|NCT02171195|O4|Outcome|Group 3 100 mg|BIA 2-093 100mg or placebo
656137|NCT02171195|O3|Outcome|Group 2 50 mg|BIA 2-093 50mg or placebo
656138|NCT02171195|O2|Outcome|Group 1 20 mg|BIA 2-093 20mg or placebo.
656139|NCT02171195|O1|Outcome|Placebo|Placebo, PLC
656140|NCT02171195|E9|Reported Event|Group 8 1200 mg|BIA 2-093 1200mg or placebo
656141|NCT02171195|E8|Reported Event|Group 7 900 mg|BIA 2-093 900mg or placebo
656142|NCT02171195|E7|Reported Event|Group 6 600 mg|BIA 2-093 600mg or placebo
656143|NCT02171195|E6|Reported Event|Group 5 400 mg|BIA 2-093 or 400mg or placebo
656144|NCT02171195|E5|Reported Event|Group 4 200 mg|BIA 2-093 200mg or placebo
656145|NCT02171195|E4|Reported Event|Group 3 100 mg|BIA 2-093 100mg or placebo
656146|NCT02171195|E3|Reported Event|Group 2 50 mg|BIA 2-093 50mg or placebo
656147|NCT02171195|E2|Reported Event|Group 1 20 mg|BIA 2-093 20mg or placebo.
656148|NCT02171195|E1|Reported Event|Placebo|Placebo, PLC
656149|NCT02170779|B3|Baseline|Total|Total of all reporting groups
656150|NCT02170779|B2|Baseline|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656151|NCT02170779|B1|Baseline|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656152|NCT02170779|P2|Participant Flow|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656153|NCT02170779|P1|Participant Flow|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656154|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656155|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656156|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656157|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656158|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656159|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656160|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656161|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656162|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656163|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656164|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656165|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656246|NCT02170532|O3|Outcome|Levalbuterol Metered Dose Inhaler (MDI) 2 Puffs|"levalbuterol metered dose inhaler (MDI) 2 puffs~levalbuterol MDI"
656166|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656167|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656168|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656169|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656170|NCT02170779|O2|Outcome|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656171|NCT02170779|O1|Outcome|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656172|NCT02170779|E2|Reported Event|B Usual Care|"2 visits: baseline and given usual treatment of brochure for stretching, outcome measures~Usual care: 2 visits: baseline followed by usual care of brochure for stretching then outcome measures"
656173|NCT02170779|E1|Reported Event|A Spasticity: Take Control|"4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures~Spasticity: Take Control: 4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures"
656174|NCT02170688|B6|Baseline|Total|Total of all reporting groups
656175|NCT02170688|B5|Baseline|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656199|NCT02170688|E1|Reported Event|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
656200|NCT02170662|B3|Baseline|Total|Total of all reporting groups
674204|NCT02017093|B3|Baseline|Total|Total of all reporting groups
656176|NCT02170688|B4|Baseline|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656177|NCT02170688|B3|Baseline|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656178|NCT02170688|B2|Baseline|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656179|NCT02170688|B1|Baseline|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
656180|NCT02170688|P5|Participant Flow|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656181|NCT02170688|P4|Participant Flow|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656403|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656182|NCT02170688|P3|Participant Flow|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656183|NCT02170688|P2|Participant Flow|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656184|NCT02170688|P1|Participant Flow|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
656185|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656186|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656201|NCT02170662|B2|Baseline|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
656432|NCT02169479|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
675917|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
656187|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656188|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656189|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
656190|NCT02170688|O5|Outcome|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656191|NCT02170688|O4|Outcome|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656192|NCT02170688|O3|Outcome|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656193|NCT02170688|O2|Outcome|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656194|NCT02170688|O1|Outcome|Fixed Dose|"50 subjects will receive contrast media based on a fixed dose. Each will receive 125 mL of Isovue 370 (370 mg of iodine/mL) administered at 4 mL/sec (1.48 gmI/sec for 31.25 sec).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert."
656195|NCT02170688|E5|Reported Event|Estimated Lean Body (eLBW) Weight|"25 subjects will receive contrast media dose based on the estimated lean body (eLBW) weight. Estimated lean body weight will be determined by using a unique software program which measures the sum of the posterior to anterior attenuation from the digital scout radiograph (abbreviated as sqrt PA) obtained during the standard planning scan of the abdominal/pelvic CT. Men will receive a dose of 0.86 gmI / kg eLBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb eLBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg eLBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb eLBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656196|NCT02170688|E4|Reported Event|Measured Lean Body Weight|"50 subjects will receive contrast media dose based on the measured lean body weight. Lean body weight will be determined using the Tanita body composition/analyzer scales. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656197|NCT02170688|E3|Reported Event|Calculated Lean Body Weight|"25 subjects will receive contrast media dose based on the calculated lean body weight. Total body weight and height will be determined. From this data the lean body weight will be calculated.~Men will receive a dose of 0.86 gmI / kg LBW (2.32 mL of Isovue 370/kg at 0.074 mL/sec/kg) or 0.39 gmI/lb LBW (1.05 mL of Isovue 370/lb at 0.034 mL/sec/lb). Women will receive a dose of 0.92 gmI/kg LBW (2.49 mL of Isovue 370/kg at 0.080 mL/sec/kg) or 0.42 gmI/lb LBW (1.13 mL of Isovue 370/kg at 0.036 mL/sec/kg).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
656198|NCT02170688|E2|Reported Event|Total Body Weight|"25 subjects will receive contrast media dose based on the total body weight. Total body weight will be determined. Both men and women will receive contrast media at a dose of 0.7 gmI/kg (1.78 mL of Isovue 370/kg) or 0.30 gmI/lb (0.81 mL of Isovue 370/lb). The injection rate will be 0.058 mL/sec/kg (0.026 mL/sec/lb).~Isovue 370: All contrast media doses administered for this study are within the FDA approved dose range in the package insert.~Weight calculation"
675918|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
656202|NCT02170662|B1|Baseline|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
656203|NCT02170662|P2|Participant Flow|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
656204|NCT02170662|P1|Participant Flow|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
656205|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
656206|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
656207|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
656208|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
656209|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
656210|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
656211|NCT02170662|O2|Outcome|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
656212|NCT02170662|O1|Outcome|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
656409|NCT02169479|B5|Baseline|Total|Total of all reporting groups
656213|NCT02170662|E2|Reported Event|Bimatoprost Then Placebo|"Part 1: Patients initially were randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were randomized to apply placebo topically for 16 weeks."
656214|NCT02170662|E1|Reported Event|Placebo Then Bimatoprost|"Part 1: Patients initially were randomized to apply placebo topically for 16 weeks.~Between Part 1 and Part 2 subjects completed a 10 day washout period.~Part 2: Patients were then randomized to apply active drug ( Bimatoprost 0.03% ophthalmic solution) topically for 16 weeks."
656215|NCT02170649|B1|Baseline|Fasting Period|single 800 mg oral dose of BIA 2-093 following 10 hours of fasting or following either a standard high fat content breakfast.
656216|NCT02170649|P1|Participant Flow|BIA 2-093 (Fasting & Fed)|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
656217|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
656218|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
656219|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
656220|NCT02170649|O1|Outcome|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
656221|NCT02170649|E1|Reported Event|Single Group|2 periods separated by a washout period of 14 days or more, on each of the study periods the volunteers received a single 800 mg oral dose of BIA 2-093 following either a standard high fat content breakfast or 10 hours of fasting.
656222|NCT02170532|B1|Baseline|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
656223|NCT02170532|P1|Participant Flow|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
656224|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
656225|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
656226|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
656227|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
656228|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
656229|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
656230|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
656231|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
656232|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
656233|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
656234|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
656235|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
656236|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
656237|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
656238|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
656239|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol MDI + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
656240|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol MDI + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
656241|NCT02170532|O3|Outcome|Levalbuterol MDI 2 Puffs|"levalbuterol metered dose inhaler 2 puffs~levalbuterol MDI"
656242|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
656243|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
656244|NCT02170532|O5|Outcome|Levalbuterol MDI + Aerochamber Max With 2 Second Pause 2 Puffs|"levalbuterol metered dose inhaler (MDI) + aerochamber max with 2 second pause 2 puffs~levalbuterol MDI~aerochamber max"
656245|NCT02170532|O4|Outcome|Levalbuterol MDI + Aerochamber Max Without Pause 2 Puffs|"levalbuterol metered-dose inhaler (MDI) + aerochamber max without pause 2 puffs~levalbuterol MDI~aerochamber max"
656247|NCT02170532|O2|Outcome|Levalbuterol + Ipratroprium in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml ipratroprium in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~breath actuated nebulizer~ipratroprium"
656248|NCT02170532|O1|Outcome|Levalbuterol + Saline in a Breath Actuated Nebulizer|"0.5 ml. levalbuterol + 0.5ml saline in a breath actuated nebulizer~levalbuterol: 0.5 ml. levalbuterol~saline: 0.5ml saline~breath actuated nebulizer"
656249|NCT02170532|E1|Reported Event|All Subjects|All subjects will receive all 5 treatments on 5 different treatment days. Each subject will receive all 5 treatments in the same order.
656250|NCT02170519|B3|Baseline|Total|Total of all reporting groups
656251|NCT02170519|B2|Baseline|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656252|NCT02170519|B1|Baseline|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656253|NCT02170519|P2|Participant Flow|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656254|NCT02170519|P1|Participant Flow|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656266|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656255|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656256|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656257|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656258|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656259|NCT02170519|O2|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656260|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656445|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656261|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656262|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656263|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656264|NCT02170519|O1|Outcome|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656265|NCT02170519|O1|Outcome|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose and data collected 5 minutes later (combined therapy). Another 1 hour period of stable baseline dose INO therapy will be given during which the final data collection will occur (end INO).~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656313|NCT02170376|E2|Reported Event|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656433|NCT02169479|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656267|NCT02170519|E2|Reported Event|Phase 1: Inhaled Iloprost 3 Doses|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized three different times on hour apart. Thirty minutes after the last iloprost dose, INO will be added back at the previous (baseline) dose.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656268|NCT02170519|E1|Reported Event|Phase 2: Inhaled Iloprost Continuous|"Each subject will have a stable dose of INO therapy as established by the attending physicians for at least one hour. Initial baseline data collection will then be made.~A 20 mcg dose of Iloprost will be given initially. During this treatment there will be a nitric oxide titration to 0. Iloprost will be aerosolized continuously at a dose of 5-30mcg/hour for as long as the attending physician deems it necessary to deliver vasodilator therapy.~Inhaled Iloprost: A 20 mcg dose of Iloprost will be given initially."
656269|NCT02170376|B6|Baseline|Total|Total of all reporting groups
656270|NCT02170376|B5|Baseline|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656271|NCT02170376|B4|Baseline|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656272|NCT02170376|B3|Baseline|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656273|NCT02170376|B2|Baseline|Group 2|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656274|NCT02170376|B1|Baseline|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656275|NCT02170376|P5|Participant Flow|Group 5: Placebo Then Levodopa/Carbidopa|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656276|NCT02170376|P4|Participant Flow|Group 4: BIA 75 mg Then Placebo/Levodopa/Carbidopa|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656277|NCT02170376|P3|Participant Flow|Group 3: BIA 50 mg Then Placebo/Levodopa/Carbidopa|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656278|NCT02170376|P2|Participant Flow|Group 2: BIA 25 mg Then Placebo/Levodopa/Carbidopa|"25 mg BIA 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656279|NCT02170376|P1|Participant Flow|Group 1: Placebo Then Entacapone/Levodopa|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656280|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
656281|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
656282|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
656283|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
656284|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
656285|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
656286|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
656287|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
656288|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
656289|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
656290|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
656291|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
656292|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
656293|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
656294|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
656295|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
656296|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
656297|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
656298|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
656299|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
656300|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
656301|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
656302|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
656303|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
656304|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
656305|NCT02170376|O5|Outcome|ENT 200 mg|Entacapone (ENT), over-encapsulated tablet 200 mg
656306|NCT02170376|O4|Outcome|OPC 75 mg|OPC: BIA 9-1067 25 mg and 50 mg
656307|NCT02170376|O3|Outcome|OPC 50 mg|OPC: BIA 9-1067 50 mg
656308|NCT02170376|O2|Outcome|OPC 25 mg|OPC: BIA 9-1067 25 mg
656309|NCT02170376|O1|Outcome|Placebo|Placebo: PLC, placebo
656310|NCT02170376|E5|Reported Event|Group 5|"placebo once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656311|NCT02170376|E4|Reported Event|Group 4|"75 mg 9-1067 once-daily for 11 days placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656312|NCT02170376|E3|Reported Event|Group 3|"50 mg 9-1067 once-daily for 11 days Placebo concomitantly with levodopa/carbidopa on Day 12~BIA 9-1067: BIA 9-1067 25 mg and 50 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656314|NCT02170376|E1|Reported Event|Group 1|"Placebo once-daily for 11 days 200 mg entacapone concomitantly with levodopa/carbidopa on Day 12~Entacapone: Entacapone (ENT), over-encapsulated tablet 200 mg~Placebo: PLC, placebo~Levodopa/carbidopa: Levodopa/carbidopa, tablet 100/25 mg"
656315|NCT02170220|B3|Baseline|Total|Total of all reporting groups
656316|NCT02170220|B2|Baseline|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656317|NCT02170220|B1|Baseline|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656318|NCT02170220|P2|Participant Flow|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656319|NCT02170220|P1|Participant Flow|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656320|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656321|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656322|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656323|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656324|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656325|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656326|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656327|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656328|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656329|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656330|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656331|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656332|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656333|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656334|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656335|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656336|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656337|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656338|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656339|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656340|NCT02170220|O2|Outcome|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656341|NCT02170220|O1|Outcome|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656342|NCT02170220|E2|Reported Event|Vortioxetine 5 mg: Severe Hepatic Impairment Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with severe hepatic impairment.
656343|NCT02170220|E1|Reported Event|Vortioxetine 5 mg: Normal Hepatic Function Cohort|Vortioxetine 5 mg, tablets, orally, once, on Day 1, in participants with normal hepatic function.
656344|NCT02170207|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656345|NCT02170207|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656346|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656347|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656348|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656349|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656350|NCT02170207|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656421|NCT02169479|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656351|NCT02170207|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 7 days followed by an observation period after the end of treatment for 8 weeks .
656352|NCT02170077|B4|Baseline|Total|Total of all reporting groups
656353|NCT02170077|B3|Baseline|PLG – Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
656354|NCT02170077|B2|Baseline|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
656355|NCT02170077|B1|Baseline|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
656356|NCT02170077|P3|Participant Flow|PLG – Placebo Group|"placebo~Placebo: Placebo tablets administered orally"
656357|NCT02170077|P2|Participant Flow|TDG - Twice-daily Group|"BIA 2-093 twice-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
656358|NCT02170077|P1|Participant Flow|ODG - Once-daily Group|"BIA 2-093 once-daily; Daily doses of BIA 2-093 were increased at four-weekly periods (400 mg, 800 mg and 1200 mg).~BIA 2-093: BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route"
656359|NCT02170077|O3|Outcome|PLG - Placebo Group|Intent to treat (TT) Population
656360|NCT02170077|O2|Outcome|TDG - Twice Daily Group|Intent to treat (TT) Population
656361|NCT02170077|O1|Outcome|ODG - Once Daily Group|Intent to treat (TT) Population
656362|NCT02170077|E3|Reported Event|PLG - Placebo Group|Intent to treat (TT) Population
656363|NCT02170077|E2|Reported Event|TDG - Twice Daily Group|Intent to treat (TT) Population
656364|NCT02170077|E1|Reported Event|ODG - Once Daily Group|Intent to treat (TT) Population
656365|NCT02170064|B4|Baseline|Total|Total of all reporting groups
656366|NCT02170064|B3|Baseline|Group 3 (12-17 Yrs)|Efficacy population (EP)
656367|NCT02170064|B2|Baseline|Group 2 (7-11 Yrs)|Efficacy population (EP)
656368|NCT02170064|B1|Baseline|Group 1 (2-6 Yrs)|Efficacy population (EP)
656404|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656405|NCT02169895|E4|Reported Event|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
656406|NCT02169895|E3|Reported Event|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656407|NCT02169895|E2|Reported Event|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656408|NCT02169895|E1|Reported Event|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656369|NCT02170064|P3|Participant Flow|Group 3 (12-17 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
656370|NCT02170064|P2|Participant Flow|Group 2 (7-11 Years)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 2 (7–11 years) and Group 3 (12–17 years), Eslicarbazepine acetate strengths 200 mg, 400 mg, 600 mg and 800 mg tablets might be used. The dose was to be rounded to the nearest 100 mg unit. Half tablets might be used for dosage adjustment (tablets were scored)."
656371|NCT02170064|P1|Participant Flow|Group 1 (2-6 Yrs)|"At the end of the baseline phase, patients meeting the final selection criteria were admitted to three consecutive 4-week treatment periods in which they received Eslicarbazepine acetate once-daily at the following dosage regimens: 5 mg/kg/day in the first 4 weeks, 15 mg/kg/day in weeks 5–8 and 30 mg/kg/day or 1800 mg/day, whichever less, in weeks 9–12. After the last treatment period, dose was down-titrated during a 2-week period or patient continued receiving Eslicarbazepine acetate (“compassionate use”) if both parent(s)/guardian(s)/patient and his/her physician agreed this was in the best patient’s interest.~For Group 1 (2–6 years), oral suspension 50 mg/mL was used. The dose was to be rounded to the nearest 25 mg unit."
656372|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
656373|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
656374|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
656375|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
656376|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
656377|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
656378|NCT02170064|O3|Outcome|Group 3 (12-17 Yrs)|Efficacy population (EP)
656379|NCT02170064|O2|Outcome|Group 2 (7-11 Yrs)|Efficacy population (EP)
656380|NCT02170064|O1|Outcome|Group 1 (2-6 Yrs)|Efficacy population (EP)
656381|NCT02170064|E3|Reported Event|Group 3 (12-17 Yrs)|Safety population (SP)
656382|NCT02170064|E2|Reported Event|Group 2 (7-11 Yrs)|Safety population (SP)
656383|NCT02170064|E1|Reported Event|Group 1 (2-6 Yrs)|Safety population (SP)
656384|NCT02169895|B5|Baseline|Total|Total of all reporting groups
656385|NCT02169895|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
656386|NCT02169895|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
656387|NCT02169895|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25"
656422|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
656423|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656388|NCT02169895|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25"
656389|NCT02169895|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
656390|NCT02169895|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
656391|NCT02169895|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
656392|NCT02169895|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~Every period with concomitant single oral administration of Prolopa® 100-25~Prolopa®: levodopa/benserazide 100/25 mg"
656393|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
656394|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656395|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656396|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656397|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
656398|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656399|NCT02169895|O2|Outcome|BIA 9-1067 50 mg Group|"BIA 9-1067 50 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656400|NCT02169895|O1|Outcome|BIA 9-1067 25 mg Group|"BIA 9-1067 25 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656401|NCT02169895|O4|Outcome|Placebo Group|"Placebo Group.~with concomitant single oral administration of Prolopa® 100-25"
656402|NCT02169895|O3|Outcome|BIA 9-1067 100 mg Group|"BIA 9-1067 100 mg Group.~with concomitant single oral administration of Prolopa® 100-25"
656410|NCT02169479|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656411|NCT02169479|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656412|NCT02169479|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656413|NCT02169479|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656414|NCT02169479|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656415|NCT02169479|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656416|NCT02169479|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656417|NCT02169479|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9- 067/Placebo was to be administered concomitantly with the a single-dose of immediate-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® 100/25~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® 100/25: Immediate-release levodopa/carbidopa 100/25 mg"
656418|NCT02169479|O4|Outcome|Placebo|Placebo, PLC
656419|NCT02169479|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656420|NCT02169479|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656435|NCT02169466|B4|Baseline|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656436|NCT02169466|B3|Baseline|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656437|NCT02169466|B2|Baseline|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656438|NCT02169466|B1|Baseline|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656439|NCT02169466|P4|Participant Flow|BIA 9-1067: Placebo, 25, 50, 100|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656440|NCT02169466|P3|Participant Flow|BIA 9-1067: 100, Placebo, 25, 50|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656441|NCT02169466|P2|Participant Flow|BIA 9-1067: 50, 100, Placebo, 25|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656442|NCT02169466|P1|Participant Flow|BIA 9-1067: 25, 50, 100, Placebo|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Madopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg"
656443|NCT02169466|O4|Outcome|Placebo|Placebo, PLC
656444|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656446|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656447|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
656448|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656449|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656450|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
656451|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
656452|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656453|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656454|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
656455|NCT02169466|O4|Outcome|Placebo|Placebo, PLC Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
656456|NCT02169466|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656457|NCT02169466|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656458|NCT02169466|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation
656459|NCT02169466|E4|Reported Event|Placebo|Placebo, PLC
656460|NCT02169466|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656461|NCT02169466|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656462|NCT02169466|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656463|NCT02169453|B5|Baseline|Total|Total of all reporting groups
656464|NCT02169453|B4|Baseline|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656465|NCT02169453|B3|Baseline|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656517|NCT02169427|P1|Participant Flow|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
656466|NCT02169453|B2|Baseline|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656467|NCT02169453|B1|Baseline|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656468|NCT02169453|P4|Participant Flow|Group 4|"Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg~Subjects were to attend four treatment periods and were to receive a different dose of BIA 9-1067 (25 mg, 50 mg and 100 mg) or placebo during each of these treatment periods.~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656469|NCT02169453|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656470|NCT02169453|P2|Participant Flow|Group 2|"Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656471|NCT02169453|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo~BIA 9-1067/Placebo was to be administered concomitantly with the dose of Sinemet® CR 100/25 (Single-dose of controlled-release levodopa/carbidopa 100/25 mg: 1 tablet of Sinemet® CR 100/25.)~BIA 9-1067: OPC, Opicapone~Placebo: PLC, Placebo~Sinemet® CR 100/25: Controlled-release levodopa/carbidopa 100/25 mg"
656472|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
656473|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656474|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656475|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656476|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
656477|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656478|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656479|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656480|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
656481|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656482|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656483|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656484|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
656485|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656486|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656487|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656488|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
656489|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656490|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656491|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656492|NCT02169453|O4|Outcome|Placebo|Placebo, PLC
656493|NCT02169453|O3|Outcome|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656494|NCT02169453|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656495|NCT02169453|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656496|NCT02169453|E4|Reported Event|Placebo|Placebo, PLC
656497|NCT02169453|E3|Reported Event|BIA 9-1067 100 mg|BIA 9-1067 100 mg OPC Opicapone
656498|NCT02169453|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg OPC Opicapone
656499|NCT02169453|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 25 mg OPC Opicapone
656500|NCT02169440|B3|Baseline|Total|Total of all reporting groups
656501|NCT02169440|B2|Baseline|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
656502|NCT02169440|B1|Baseline|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
656503|NCT02169440|P2|Participant Flow|Group 2: Warfarin, Then BIA 9-1067 + Warfarin|"Period 1: warfarin Period 2: BIA 9-1067 + warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
656504|NCT02169440|P1|Participant Flow|Group 1: BIA 9-1067 + Warfarin, Then Warfarin|"Period 1: BIA 9-1067 + warfarin Period 2: warfarin~BIA 9-1067: BIA 9-1067 25 mg~Warfarin: Warfarin 25 mg"
656505|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
656506|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
656507|NCT02169440|O1|Outcome|Warfarin + BIA 9-1067|25 mg warfarin + 25 mg BIA 9-1067
656508|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
656509|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
656510|NCT02169440|O1|Outcome|Warfarin Alone|Warfarin 25 mg
656511|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
656512|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
656513|NCT02169440|O1|Outcome|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg + Warfarin 25 mg
656514|NCT02169440|E2|Reported Event|Warfarin|Warfarin 25 mg
656515|NCT02169440|E1|Reported Event|BIA 9-1067 + Warfarin|BIA 9-1067 25 mg Warfarin 25 mg
656516|NCT02169427|B1|Baseline|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
656678|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
656518|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
656519|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
656520|NCT02169427|O1|Outcome|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
656521|NCT02169427|E1|Reported Event|Opicapone (OPC)|"100 mg OPC~OPC: The drug substance of 100 mg OPC was administered as 1 capsule."
656522|NCT02169414|B5|Baseline|Total|Total of all reporting groups
656523|NCT02169414|B4|Baseline|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656524|NCT02169414|B3|Baseline|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656525|NCT02169414|B2|Baseline|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656526|NCT02169414|B1|Baseline|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656527|NCT02169414|P4|Participant Flow|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656528|NCT02169414|P3|Participant Flow|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656529|NCT02169414|P2|Participant Flow|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656555|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
668064|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
656530|NCT02169414|P1|Participant Flow|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656531|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656532|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656533|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656534|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656535|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656536|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656537|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656538|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656539|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656540|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656541|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656542|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656569|NCT02169336|B2|Baseline|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656543|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 25 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656544|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656545|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. BIA 9-1067 5 mg: OPC, Opicapone Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656546|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days Levodopa/benserazide 100/25 mg was administered on Day 18. Placebo: PLC, Placebo Levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide
656547|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656548|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
656549|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656550|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656551|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656552|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
656553|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656554|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656613|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656556|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
656557|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656558|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656559|NCT02169414|O4|Outcome|BIA 9-1067 50 mg|2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 25 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656560|NCT02169414|O3|Outcome|BIA 9-1067 15 mg|3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25
656561|NCT02169414|O2|Outcome|BIA 9-1067 5 mg|1 capsule of 5 mg + 2 capsules of placebo for 18 days. Levodopa/carbidopa 100/25 mg was administered on Day 11 BIA 9-1067 5 mg: OPC, Opicapone. Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656562|NCT02169414|O1|Outcome|Placebo|3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 Levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25 Placebo: PLC, Placebo
656563|NCT02169414|E4|Reported Event|BIA 9-1067 50 mg|"2 capsules of BIA 9-1067 25 mg + 1 capsule of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 25 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656564|NCT02169414|E3|Reported Event|BIA 9-1067 15 mg|"3 capsules of 5 mg for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656565|NCT02169414|E2|Reported Event|BIA 9-1067 5 mg|"1 capsule of 5 mg + 2 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~BIA 9-1067 5 mg: OPC, Opicapone~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656566|NCT02169414|E1|Reported Event|Placebo|"3 capsules of placebo for 18 days levodopa/carbidopa 100/25 mg was administered on Day 11 levodopa/benserazide 100/25 mg was administered on Day 18.~levodopa/carbidopa 100/25: immediate (standard) release levodopa/carbidopa 100/25~Placebo: PLC, Placebo~levodopa/benserazide 100/25 mg: immediate (standard) release levodopa/benserazide"
656567|NCT02169336|B4|Baseline|Total|Total of all reporting groups
656568|NCT02169336|B3|Baseline|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
656570|NCT02169336|B1|Baseline|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656571|NCT02169336|P3|Participant Flow|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
656572|NCT02169336|P2|Participant Flow|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656573|NCT02169336|P1|Participant Flow|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656574|NCT02169336|O3|Outcome|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
656575|NCT02169336|O2|Outcome|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656576|NCT02169336|O1|Outcome|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656577|NCT02169336|E3|Reported Event|IN Placebo|"IN Placebo every 6 hours for 48 hours. IN Placebo PRN for up to 3 additional days.~Intranasal Placebo"
656578|NCT02169336|E2|Reported Event|DEX-IN 50mcg|"DEX-IN 50mcg every 6 hours for 48 hours. DEX-IN 50mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656579|NCT02169336|E1|Reported Event|DEX-IN 35mcg|"DEX-IN 35mcg every 6 hours for 48 hours. DEX-IN 35mcg PRN for up to 3 additional days.~Intranasal Dexmedetomidine"
656580|NCT02169115|B4|Baseline|Total|Total of all reporting groups
656581|NCT02169115|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
656582|NCT02169115|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
656583|NCT02169115|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
656584|NCT02169115|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
656585|NCT02169115|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
656586|NCT02169115|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
656587|NCT02169115|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
656588|NCT02169115|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
656589|NCT02169115|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
656590|NCT02169115|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
656591|NCT02169115|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
656592|NCT02169115|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
656593|NCT02168491|B1|Baseline|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
656614|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656615|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656594|NCT02168491|P1|Participant Flow|Lixisenatide With Basal Insulin (LixiBIT)|"Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide~Lixisenatide: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.~Insulin glargine: Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of"
656595|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
656596|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
656597|NCT02168491|O1|Outcome|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
656598|NCT02168491|E1|Reported Event|Lixisenatide With Basal Insulin (LixiBIT)|Type 2 diabetic patients will be included to perform in this study and will be switched from premixed insulin to insulin glargine and lixisenatide
656599|NCT02168478|B1|Baseline|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~All test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate applied to the absorbent pad portion of a semi-occlusive dressing and applied to upper back between the scapulae.~Saline: Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae."
656600|NCT02168478|P1|Participant Flow|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline.~Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Saline is applied to the absorbent pad portion of a"
656633|NCT02168387|E2|Reported Event|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
656679|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites, standard care
656601|NCT02168478|O1|Outcome|Patch Test Group|"Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 mL of the positive, 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.~Saline: Approximately 0.2 mL of saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours."
656602|NCT02168478|E1|Reported Event|Patch Test Group|"All subjects are patched with the following: 1.Neo-Synalar Cream 2.Sodium Lauryl Sulfate and 3. Saline. Test material is applied to the absorbent pad and allowed to remain in direct skin contact for a period of 48 hours.~Neo-Synalar Cream: Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae.~Sodium Lauryl Sulfate Aqueous Solution (0.40%): Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae.~Saline: Approximately 0.2 ml of the saline is applied to the absorbent pad portion of an occlusive dressing and applied as received to the upper back between the scapulae."
656603|NCT02168439|B3|Baseline|Total|Total of all reporting groups
656604|NCT02168439|B2|Baseline|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: ."
656605|NCT02168439|B1|Baseline|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: ."
656606|NCT02168439|P2|Participant Flow|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656607|NCT02168439|P1|Participant Flow|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656608|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656609|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656610|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656611|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656612|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656616|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656617|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656618|NCT02168439|O2|Outcome|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656619|NCT02168439|O1|Outcome|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656620|NCT02168439|E2|Reported Event|Midazolam|"Intranasal Midazolam 0.4 milligram/kilogram~Midazolam: 20 patients enrolled, 18 underwent analysis"
656621|NCT02168439|E1|Reported Event|Dexmedetomidine|"Intranasal Dexmedetomidine 2 micrograms/kilogram once~Dexmedetomidine: 20 patients enrolled, 20 underwent analysis"
656622|NCT02168387|B3|Baseline|Total|Total of all reporting groups
656623|NCT02168387|B2|Baseline|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
656624|NCT02168387|B1|Baseline|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
656625|NCT02168387|P2|Participant Flow|Continuous High Frequency Oscillator (CHFO)|"Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.~continuous high frequency oscillator (CHFO)"
656626|NCT02168387|P1|Participant Flow|Medication|"Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.~Acetylcysteine~dornase alfa"
656627|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
656628|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
656629|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
656630|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
656631|NCT02168387|O2|Outcome|Continuous High Frequency Oscillator (CHFO)|Subjects randomized to receive therapy with the CHFO will receive a 20 minute treatment every 6 hours for 48 hours.
656632|NCT02168387|O1|Outcome|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
656677|NCT02167815|P1|Participant Flow|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
656634|NCT02168387|E1|Reported Event|Medication|Subjects randomized to receive the medications will receive acetylcysteine and dornase alfa, two medications frequently used in the treatment of atelectasis. The medications will alternate every 6 hours for 48 hours.
656635|NCT02168361|B3|Baseline|Total|Total of all reporting groups
656636|NCT02168361|B2|Baseline|Interferon-containing Arm|
656637|NCT02168361|B1|Baseline|Oral Therapy Arm|
656638|NCT02168361|P2|Participant Flow|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
656639|NCT02168361|P1|Participant Flow|All Oral Therapy|Simeprevir-sofosbuvir
656640|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
656641|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
656642|NCT02168361|O2|Outcome|Interferon-containing Arm|Peginterferon/ribavirin/sofosbuvir
656643|NCT02168361|O1|Outcome|All Oral Therapy|Simeprevir-sofosbuvir
656644|NCT02168361|E2|Reported Event|Interferon-containing|
656645|NCT02168361|E1|Reported Event|All Oral|
656646|NCT02167893|B1|Baseline|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656647|NCT02167893|P1|Participant Flow|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656648|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656649|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656650|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656651|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656652|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656653|NCT02167893|O1|Outcome|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656654|NCT02167893|E1|Reported Event|Leuprorelin Acetate|Participants receiving leuprorelin acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks as daily medical practice were observed.
656655|NCT02166697|B1|Baseline|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656656|NCT02166697|P1|Participant Flow|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656657|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656658|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656659|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656660|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656661|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656662|NCT02166697|O1|Outcome|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656663|NCT02166697|E1|Reported Event|Candesartan Cilexetil|Candesartan cilexetil 4 mg, tablet, orally, once daily for up to 3 years.
656664|NCT02167867|B3|Baseline|Total|Total of all reporting groups
656665|NCT02167867|B2|Baseline|Treatment Subject Group|Treatment subjects received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
656666|NCT02167867|B1|Baseline|Lay End Users|Employees of the test sites (that were fitness centers or spas) who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of one Treatment Subject.
656667|NCT02167867|P2|Participant Flow|Treatment Subject Group|Subjects who received active treatments with the study device administered by the Lay End Users.
656668|NCT02167867|P1|Participant Flow|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist, hips and thighs of a Treatment Subject.
656669|NCT02167867|O1|Outcome|Treatment Subject Group|Individuals who got the active treatments with the ZERONA Z6.
656670|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
656671|NCT02167867|O1|Outcome|Lay End Users|Employees of the test sites that were fitness centers or spas who were provided with a User's Manual to operate the ZERONA Z6 to administer 6 40-minute evenly spaced treatments over 2 consecutive weeks to the front and back of the waist. hips and thighs.
656672|NCT02167867|E1|Reported Event|ZERONA Z6|"ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes. 6 40-minute evenly spaced treatments are administered over 2 consecutive weeks.~ZERONA Z6: 20 minutes of treatment to the front side of the waist, hips and thighs and 20 minutes of treatment to the back side of the waist, hips and thighs."
656673|NCT02167815|B3|Baseline|Total|Total of all reporting groups
656674|NCT02167815|B2|Baseline|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
656675|NCT02167815|B1|Baseline|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
656676|NCT02167815|P2|Participant Flow|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
675919|NCT02009865|E2|Reported Event|Olive Oil|2g once daily (QD)
656680|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
656681|NCT02167815|O2|Outcome|Standard Care|observation group, treated according to investigation sites standard care
656682|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
656683|NCT02167815|O2|Outcome|Standard Care|observation group, treating according to investigation sites standard care
656684|NCT02167815|O1|Outcome|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
656685|NCT02167815|E2|Reported Event|Intervention ( Mepilex XT)|Mepilex XT: Experimental arm
656686|NCT02167815|E1|Reported Event|Standard Care|"standard care ( such as alginate, hydrofiber or other treatment)~standard care"
656687|NCT02167139|B3|Baseline|Total|Total of all reporting groups
656688|NCT02167139|B2|Baseline|Humira (Adalimumab)|"Humira 40 mg every other week via subcutaneous injection~Humira (adalimumab)~SB5 (proposed biosimilar to adalimumab)"
656689|NCT02167139|B1|Baseline|SB5 (Proposed Biosimilar to Adalimumab)|"SB5 40 mg every other week via subcutaneous injection~SB5 (proposed biosimilar to adalimumab)"
656690|NCT02167139|P4|Participant Flow|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
656691|NCT02167139|P3|Participant Flow|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
656692|NCT02167139|P2|Participant Flow|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
656693|NCT02167139|P1|Participant Flow|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
656694|NCT02167139|O5|Outcome|Humira (Adalimumab), Continue as Humira at Week 52|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
656695|NCT02167139|O4|Outcome|Humira (Adalimumab), Switch to SB5 at Week 52|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
656696|NCT02167139|O3|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 52|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
656697|NCT02167139|O2|Outcome|Humira (Adalimumab) at Week 24|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
656698|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab) at Week 24|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
656699|NCT02167139|O3|Outcome|Humira (Adalimumab), Continue as Humira|From Week 24, Humira® 40 mg (Humira®/Humira®) every other week up to Week 50.
656700|NCT02167139|O2|Outcome|Humira (Adalimumab), Switch to SB5|From Week 24, SB5 40 mg (Humira®/SB5) every other week up to Week 50.
656701|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
656702|NCT02167139|O2|Outcome|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection up to Week 24
656703|NCT02167139|O1|Outcome|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection up to Week 24
656704|NCT02167139|E2|Reported Event|Humira (Adalimumab)|Humira 40 mg every other week via subcutaneous injection to Week 24, then randomised again in a 1:1 ratio to either continue on Humira® 40 mg (Humira®/Humira®) or be transitioned to SB5 40 mg (Humira®/SB5) every other week up to Week 50.
656705|NCT02167139|E1|Reported Event|SB5 (Proposed Biosimilar to Adalimumab)|SB5 40 mg every other week via subcutaneous injection SB5 (proposed biosimilar to adalimumab)
656706|NCT02165826|B4|Baseline|Total|Total of all reporting groups
656707|NCT02165826|B3|Baseline|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656708|NCT02165826|B2|Baseline|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656709|NCT02165826|B1|Baseline|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656710|NCT02165826|P3|Participant Flow|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656711|NCT02165826|P2|Participant Flow|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656712|NCT02165826|P1|Participant Flow|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656713|NCT02165826|O2|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 12|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 12.
656714|NCT02165826|O1|Outcome|Roflumilast 500 μg OD_CFB in FEV1 @ Week 4|Roflumilast 500 μg, tablets, orally, once daily (OD) for 12 weeks. Results for Change from Baseline in FEV1 at Week 4.
656715|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656716|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, orally, every other day (EOD) at least 1 dose in the Main Period
656717|NCT02165826|O1|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656718|NCT02165826|O2|Outcome|Roflumilast 250 μg OD|Roflumilast 500 μg at least one dose in the Main Period followed by Roflumilast 250 μg tablets, orally, once daily in the Down -Titration Period.
656719|NCT02165826|O1|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656720|NCT02165826|O4|Outcome|Roflumilast 250 µg Down-Titration|250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656721|NCT02165826|O3|Outcome|Roflumilast 250 μg OD|Roflumilast 250 μg tablets, orally, once daily in the Main Period.
656722|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD|Roflumilast 500 μg, tablets, orally, every other day (EOD) in the Main Period.
656723|NCT02165826|O1|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656724|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
656725|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
656726|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
656727|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
656728|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
656729|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
656730|NCT02165826|O2|Outcome|All PK Participants_Roflumilast N-oxide|All PK participants who received any dose of rofumilast. Results for roflumilast N-oxide.
656731|NCT02165826|O1|Outcome|All PK Participants_Roflumilast|All PK participants who received any dose of roflumilast. Results for roflumilast.
656732|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656733|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656734|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656735|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656866|NCT02164396|B4|Baseline|Total|Total of all reporting groups
656736|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656737|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656738|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656739|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656740|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656741|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656742|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656743|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656744|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656745|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
675920|NCT02009865|E1|Reported Event|Epanova|2g once daily (QD)
656746|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656747|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656748|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656749|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656750|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656751|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656752|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656753|NCT02165826|O3|Outcome|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656754|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656755|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656756|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656757|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656758|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656759|NCT02165826|O3|Outcome|Roflumilast 500 μg OD|Roflumilast 500 μg, tablets, orally, once daily (OD) at least 1 dose in the Main Period.
656760|NCT02165826|O2|Outcome|Roflumilast 500 μg EOD Then 500 μg OD|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656761|NCT02165826|O1|Outcome|Roflumilast 250 μg OD Then 500 μg OD|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656762|NCT02165826|E6|Reported Event|Roflumilast 500 μg OD_Down Titration Period|Participants in the roflumilast 500 μg once daily (OD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656763|NCT02165826|E5|Reported Event|Roflumilast 500 μg EOD_Down-Titration Period|Participants in the roflumilast 500 μg, every other day (EOD) treatment arm who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656764|NCT02165826|E4|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Down Titration Period|Participants in the roflumilast 250 μg once daily (OD) then 500 μg OD who were not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656765|NCT02165826|E3|Reported Event|Roflumilast 500 μg OD_Main Treatment Period|Roflumilast 500 μg tablets, orally, once daily for 12 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656838|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656766|NCT02165826|E2|Reported Event|Roflumilast 500 μg EOD Then 500 μg OD_Main Treatment Period|Roflumilast 500 μg, tablets, orally, every other day (EOD), and roflumilast placebo-matching tablets, orally, every other day on non-treatment days, for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656767|NCT02165826|E1|Reported Event|Roflumilast 250 μg OD Then 500 μg OD_Main Treatment Period|Roflumilast 250 μg, tablets, orally, once daily (OD) for 4 weeks, followed by roflumilast 500 μg, tablets, orally, once daily, for 8 weeks in the Main Treatment Period. Any participants not tolerating study treatment were prematurely discontinued and received roflumilast 250 μg, tablets, orally, once daily for 8 weeks in the open-label Down-Titration Period.
656768|NCT02165462|B1|Baseline|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656769|NCT02165462|P1|Participant Flow|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656770|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656771|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656772|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656773|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656774|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656775|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656776|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656777|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656778|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656779|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656780|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656781|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656782|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656783|NCT02165462|O1|Outcome|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656784|NCT02165462|E1|Reported Event|Patients With Haemophilia|"Assessment of bilateral deficit phenomenon during dynamic plantar flexion task~Patients with haemophilia: Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)"
656785|NCT02165111|B3|Baseline|Total|Total of all reporting groups
656786|NCT02165111|B2|Baseline|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656936|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656787|NCT02165111|B1|Baseline|Onabotulinumtoxin A|"One hand of each patient was be randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656788|NCT02165111|P2|Participant Flow|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each)."
656789|NCT02165111|P1|Participant Flow|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand."
656790|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656791|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656792|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656902|NCT02164318|E2|Reported Event|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
656903|NCT02164318|E1|Reported Event|Control Group|Standard of care
656793|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656794|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656795|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656796|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656797|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656798|NCT02165111|O2|Outcome|Placebo|"One hand of each patient were randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656817|NCT02164539|P6|Participant Flow|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656937|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656799|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient were randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656800|NCT02165111|O2|Outcome|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656801|NCT02165111|O1|Outcome|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656802|NCT02165111|E2|Reported Event|Placebo|"One hand of each patient was randomly selected for injection of sterile saline solution (placebo).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (0.5 mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (0.25 mL each).~sterile saline solution"
656803|NCT02165111|E1|Reported Event|Onabotulinumtoxin A|"One hand of each patient was randomly selected for injection of Botulinum Toxin A (Onabotulinumtoxin A, 20 units/mL).~Injections were performed using a 30 gauge insulin syringe through the dorsal surface in seven locations: adjacent to the 2nd, 3rd, and 4th common digital arteries through the web spaces (10 units each=0.5mL each), and the radial side of the index finger metacarpal head, the ulnar side of the small finger metacarpal head, and each side of the thumb metacarpal head (5 units each= 0.25mL each). Total treatment dose of Botulinum Toxin A will not exceed 50 units per hand.~Onabotulinumtoxin A"
656804|NCT02165072|B1|Baseline|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
656904|NCT02163915|B6|Baseline|Total|Total of all reporting groups
658035|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
656805|NCT02165072|P1|Participant Flow|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
656806|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
656807|NCT02165072|O1|Outcome|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
656808|NCT02165072|E1|Reported Event|Ultrasound of Acute Kidney Injury|This study represents a convenience sample of patients admitted to a medical intensive care unit with laboratory evidence of acute kidney injury. This is a prospective study. There is one study group only. There is no randomization.
656809|NCT02164539|B7|Baseline|Total|Total of all reporting groups
656810|NCT02164539|B6|Baseline|FF/VI 100/25 µg|Participants received FF 100 µg in combination with VI 25 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656811|NCT02164539|B5|Baseline|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656812|NCT02164539|B4|Baseline|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656813|NCT02164539|B3|Baseline|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656814|NCT02164539|B2|Baseline|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with UMEC 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656815|NCT02164539|B1|Baseline|FF 100 µg|Participants received FF 100 µg once daily in the morning by inhalation using a DPI for 4 weeks in Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656816|NCT02164539|P7|Participant Flow|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656884|NCT02164318|P4|Participant Flow|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
656818|NCT02164539|P5|Participant Flow|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656819|NCT02164539|P4|Participant Flow|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656820|NCT02164539|P3|Participant Flow|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656821|NCT02164539|P2|Participant Flow|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656822|NCT02164539|P1|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656823|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656824|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656825|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656905|NCT02163915|B5|Baseline|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
658036|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
656826|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656827|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656828|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656829|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656830|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656831|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656832|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656833|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656834|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656835|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656836|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656837|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656885|NCT02164318|P3|Participant Flow|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
656839|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656840|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656841|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656842|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656843|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656844|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656845|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656846|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656906|NCT02163915|B4|Baseline|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
668112|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
656847|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656848|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656849|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656850|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656851|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656852|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656853|NCT02164539|O6|Outcome|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656854|NCT02164539|O5|Outcome|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656855|NCT02164539|O4|Outcome|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656856|NCT02164539|O3|Outcome|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656857|NCT02164539|O2|Outcome|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656858|NCT02164539|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656886|NCT02164318|P2|Participant Flow|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
656887|NCT02164318|P1|Participant Flow|Control Group|Standard of care
656938|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656859|NCT02164539|E7|Reported Event|FF/UMEC/VI 100/250/25 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 250 µg and VI 25 µg once daily in the morning by inhalation using two separate DPIs (FF/UMEC 100/250 &amp;amp; VI 25) for 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656860|NCT02164539|E6|Reported Event|FF/VI 100/25 µg|Participants received FF 100 µg in combination with vilanterol trifenatate (VI) 25 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656861|NCT02164539|E5|Reported Event|FF/UMEC 100/250 µg|Participants received FF 100 µg in combination with UMEC 250 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A and 1 week during Treatment Phase B and C. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656862|NCT02164539|E4|Reported Event|FF/UMEC 100/125 µg|Participants received FF 100 µg in combination with UMEC 125 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656863|NCT02164539|E3|Reported Event|FF/UMEC 100/62.5 µg|Participants received FF 100 µg in combination with UMEC 62.5 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656864|NCT02164539|E2|Reported Event|FF/UMEC 100/15.6 µg|Participants received FF 100 µg in combination with umeclidinium bromide (UMEC) 15.6 µg once daily in the morning by inhalation using a DPI for 4 weeks during Treatment Phase A. In addition, all participants received supplemental albuterol/salbutamol via MDI to be used on an as-needed basis (rescue medication) throughout the study.
656865|NCT02164539|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 µg once daily in the morning by inhalation using a dry powder inhaler (DPI) for 4 weeks during Treatment Phase A and 1 week during Treatment Phase C. In addition, all participants received supplemental albuterol/salbutamol via metered-dose inhaler (MDI) to be used on an as-needed basis (rescue medication) throughout the study.
656867|NCT02164396|B3|Baseline|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
656868|NCT02164396|B2|Baseline|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
656869|NCT02164396|B1|Baseline|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
656870|NCT02164396|P3|Participant Flow|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
656871|NCT02164396|P2|Participant Flow|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
656872|NCT02164396|P1|Participant Flow|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
656873|NCT02164396|O3|Outcome|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
656874|NCT02164396|O2|Outcome|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
656875|NCT02164396|O1|Outcome|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
656876|NCT02164396|E3|Reported Event|Senofilcon A or Narafilcon A|Consists of subjects that were randomized to receive the test lens. In this study there are 2 test lenses. Subjects that were randomized to the test lens were further stratified to either senofilcon A or narafilcon A based on the modality of the habitual contact lens (senofilcon A: Reusable; narafilcon A: Daily Disposable).
656877|NCT02164396|E2|Reported Event|Habitual Soft Contact Lens|Consists of subjects that were randomized to wear their habitual lens and are the contact lenses used by the subjects prior to participating in the clinical trial. Various types/brands are used by subjects prior to participation.
656878|NCT02164396|E1|Reported Event|Spectacles|Consists of subjects that were randomized to wear spectacles throughout the duration of the study.
656879|NCT02164318|B5|Baseline|Total|Total of all reporting groups
656880|NCT02164318|B4|Baseline|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
656881|NCT02164318|B3|Baseline|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
656882|NCT02164318|B2|Baseline|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
656883|NCT02164318|B1|Baseline|Control Group|Standard of care
656934|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656935|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656888|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
656889|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
656890|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
656891|NCT02164318|O1|Outcome|Control Group|Standard of care
656892|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
656893|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
656894|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
656895|NCT02164318|O1|Outcome|Control Group|Standard of care
656896|NCT02164318|O4|Outcome|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
656897|NCT02164318|O3|Outcome|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
656898|NCT02164318|O2|Outcome|Handgrip Training Group|"Perform isometric handgrip exercises for 15 minutes twice per day for a total of 30 minutes~Handgrip training"
656899|NCT02164318|O1|Outcome|Control Group|Standard of care
656900|NCT02164318|E4|Reported Event|Combined Handgrip Training /Nitroglycerin Ointment Group|"Perform isometric handgrip exercises for 15 minutes twice each day for a total of 30 minutes and apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Handgrip training~Nitroglycerin ointment"
656901|NCT02164318|E3|Reported Event|Nitroglycerin Ointment Group|"Apply 15mg of nitroglycerin ointment to the back of the hand of the surgical arm nightly~Nitroglycerin ointment"
656907|NCT02163915|B3|Baseline|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656908|NCT02163915|B2|Baseline|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656909|NCT02163915|B1|Baseline|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656910|NCT02163915|P5|Participant Flow|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656911|NCT02163915|P4|Participant Flow|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656912|NCT02163915|P3|Participant Flow|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656913|NCT02163915|P2|Participant Flow|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656914|NCT02163915|P1|Participant Flow|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656915|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656916|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656917|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656918|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656919|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656920|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656921|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656922|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656923|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656924|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656925|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656926|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656927|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656928|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656929|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656930|NCT02163915|O2|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656931|NCT02163915|O1|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656932|NCT02163915|O4|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656933|NCT02163915|O3|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656996|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656939|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656940|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656941|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656942|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656943|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656944|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656945|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656946|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656947|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656948|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656949|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656950|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656951|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656952|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656953|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656954|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656955|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656956|NCT02163915|O5|Outcome|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656957|NCT02163915|O4|Outcome|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
656958|NCT02163915|O3|Outcome|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656959|NCT02163915|O2|Outcome|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656960|NCT02163915|O1|Outcome|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656961|NCT02163915|E5|Reported Event|Cohort 4: TAK-137 10 mg|TAK-137 10 mg, tablets, orally once on Days 1-7 under fasting condition.
656962|NCT02163915|E4|Reported Event|Cohort 3: TAK-137 5 mg|TAK-137 5 mg, tablets, orally once on Days 1-7 under fasting condition.
669379|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
656963|NCT02163915|E3|Reported Event|Cohort 2: TAK-137 2 mg|TAK-137 2 mg, tablets, orally once on Days 1-7 under fasting condition.
656964|NCT02163915|E2|Reported Event|Cohort 1: TAK-137 0.5 mg|TAK-137 0.5 mg, tablets, orally once on Days 1-7 under fasting condition.
656965|NCT02163915|E1|Reported Event|Cohorts 1-4: Placebo|TAK-137 placebo-matching tablets, orally, once on Days 1-7 under fasting conditions.
656966|NCT02163733|B3|Baseline|Total|Total of all reporting groups
656967|NCT02163733|B2|Baseline|Fasted/Fed|AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
656968|NCT02163733|B1|Baseline|Fed/Fasted|AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
656969|NCT02163733|P2|Participant Flow|Fasted/Fed|AZD9291 tablets following a period of fasting in Period 1, then AZD9291 tablets following a high-fat meal in Period 2.
656970|NCT02163733|P1|Participant Flow|Fed/Fasted|AZD9291 tablets following a high-fat meal in Period 1, then AZD9291 tablets following a period of fasting in Period 2.
656971|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656972|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656973|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656974|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656975|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656976|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656977|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656978|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656979|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656980|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656981|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656982|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656983|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656984|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656985|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656986|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656987|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656988|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656989|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656990|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656991|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656992|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656993|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656994|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656995|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
675921|NCT02009722|B3|Baseline|Total|Total of all reporting groups
656997|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
656998|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
656999|NCT02163733|O2|Outcome|Fasted|AZD9291 tablets following a period of fasting
657000|NCT02163733|O1|Outcome|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
657001|NCT02163733|E3|Reported Event|Overall|Fed and Fasted periods combined.
657002|NCT02163733|E2|Reported Event|Fasted|AZD9291 tablets following a period of fasting
657003|NCT02163733|E1|Reported Event|Fed (High-fat Meal)|AZD9291 tablets following a high-fat meal
657004|NCT02163421|B5|Baseline|Total|Total of all reporting groups
657005|NCT02163421|B4|Baseline|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657006|NCT02163421|B3|Baseline|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657007|NCT02163421|B2|Baseline|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657008|NCT02163421|B1|Baseline|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
657009|NCT02163421|P4|Participant Flow|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657010|NCT02163421|P3|Participant Flow|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657011|NCT02163421|P2|Participant Flow|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657012|NCT02163421|P1|Participant Flow|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
657013|NCT02163421|O1|Outcome|Vedolizumab Subcutaneous|Vedolizumab 54 mg or 108 mg or 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657014|NCT02163421|E4|Reported Event|Vedolizumab Subcutaneous 160 mg|Vedolizumab 160 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657015|NCT02163421|E3|Reported Event|Vedolizumab Subcutaneous 108 mg|Vedolizumab 108 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657016|NCT02163421|E2|Reported Event|Vedolizumab Subcutaneous 54 mg|Vedolizumab 54 mg, injection, subcutaneously, once only on Day 1 in a treatment period of 168 days.
657017|NCT02163421|E1|Reported Event|Vedolizumab Intravenous 300 mg|Vedolizumab 300 mg, 30-minutes infusion, intravenously once only on Day 1 in a treatment period of 168 days.
657018|NCT02163395|B1|Baseline|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
657019|NCT02163395|P1|Participant Flow|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
657020|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
657021|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
657022|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
657023|NCT02163395|O1|Outcome|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
657024|NCT02163395|E1|Reported Event|FullCeram Implant|"Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment hights of 4.0 or 5.5 mm~FullCeram implant: FullCeram implantation"
657025|NCT02162979|B3|Baseline|Total|Total of all reporting groups
657026|NCT02162979|B2|Baseline|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
657027|NCT02162979|B1|Baseline|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
657028|NCT02162979|P2|Participant Flow|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
657029|NCT02162979|P1|Participant Flow|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
657030|NCT02162979|O2|Outcome|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
657031|NCT02162979|O1|Outcome|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
657032|NCT02162979|E2|Reported Event|Placebo Comparator|"subjects will be randomized to placebo treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~Placebo"
657033|NCT02162979|E1|Reported Event|Viagra|"subjects will be randomized to active treatment for 2 weeks, washout for 1 week, then enter the other study arm for two weeks.~sildenafil: sildenafil 50mg BID for 2 weeks"
657034|NCT02162758|B3|Baseline|Total|Total of all reporting groups
657035|NCT02162758|B2|Baseline|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
657036|NCT02162758|B1|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
657037|NCT02162758|P2|Participant Flow|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
657038|NCT02162758|P1|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
657039|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
657040|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
657041|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
657042|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
657043|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
657044|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
657045|NCT02162758|O2|Outcome|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
657046|NCT02162758|O1|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
657047|NCT02162758|E2|Reported Event|Dexlansoprazole 60 mg BID|Dexlansoprazole 60 mg, capsules, orally, BID for up to 12 months.
657048|NCT02162758|E1|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed-release capsules, orally, QD and dexlansoprazole placebo-matching capsules, orally, QD for up to 12 months.
657049|NCT02162680|B4|Baseline|Total|Total of all reporting groups
657050|NCT02162680|B3|Baseline|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
657051|NCT02162680|B2|Baseline|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
657052|NCT02162680|B1|Baseline|no Local Anesthetic|usual care practice of no local anesthetic administration
657053|NCT02162680|P3|Participant Flow|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
657054|NCT02162680|P2|Participant Flow|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
657055|NCT02162680|P1|Participant Flow|no Local Anesthetic|usual care practice of no local anesthetic administration
657056|NCT02162680|O3|Outcome|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
657057|NCT02162680|O2|Outcome|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
657058|NCT02162680|O1|Outcome|no Local Anesthetic|usual care practice of no local anesthetic administration
657059|NCT02162680|E3|Reported Event|Bacteriostatic Normal Saline (BNS)|"bacteriostatic normal saline (BNS) injection~bacteriostatic normal saline (BNS)"
657060|NCT02162680|E2|Reported Event|Lidocaine|"1% lidocaine intradermal injection~1% lidocaine"
657061|NCT02162680|E1|Reported Event|no Local Anesthetic|usual care practice of no local anesthetic administration
657062|NCT02161549|B3|Baseline|Total|Total of all reporting groups
657063|NCT02161549|B2|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
657064|NCT02161549|B1|Baseline|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
657065|NCT02161549|P2|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
657066|NCT02161549|P1|Participant Flow|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
657067|NCT02161549|O2|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
657068|NCT02161549|O1|Outcome|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
657069|NCT02161549|E2|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.5|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.5 , enrolled under protocol Rev 2.0~Motus Gl CleanUp System"
657070|NCT02161549|E1|Reported Event|Colonoscopy With MotusGi CleanUp System Rev 1.0|"subjects indicated for colonoscopy procedure with CleanUp System Rev 1.0 , enrolled under protocol Rev 1.0~Motus Gl CleanUp System"
657071|NCT02161146|B6|Baseline|Total|Total of all reporting groups
657072|NCT02161146|B5|Baseline|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
657073|NCT02161146|B4|Baseline|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
657074|NCT02161146|B3|Baseline|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
657075|NCT02161146|B2|Baseline|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
657076|NCT02161146|B1|Baseline|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
657077|NCT02161146|P5|Participant Flow|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
657078|NCT02161146|P4|Participant Flow|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
657079|NCT02161146|P3|Participant Flow|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
657080|NCT02161146|P2|Participant Flow|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
657081|NCT02161146|P1|Participant Flow|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
657082|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
657083|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
657084|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
677621|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
657085|NCT02161146|O3|Outcome|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
657086|NCT02161146|O2|Outcome|Vehicle|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
657087|NCT02161146|O1|Outcome|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
657088|NCT02161146|E5|Reported Event|AGN-229666/Vehicle|One drop of AGN-229666 in one eye and one drop of Vehicle to AGN-229666 in the other eye on Days 1 and 15.
657089|NCT02161146|E4|Reported Event|AGN-229666/Olopatadine|One drop of AGN-229666 in one eye and one drop of olopatadine in the other eye on Days 1 and 15.
657090|NCT02161146|E3|Reported Event|Olopatadine|One drop of olopatadine in each eye on Days 1 and 15.
657091|NCT02161146|E2|Reported Event|Vehicle|One drop of Vehicle to AGN-229666 in each eye on Days 1 and 15.
657092|NCT02161146|E1|Reported Event|AGN-229666|One drop of AGN-229666 in each eye on Days 1 and 15.
657093|NCT02161016|B1|Baseline|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657094|NCT02161016|P1|Participant Flow|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657095|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657096|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657097|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657098|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657099|NCT02161016|O1|Outcome|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657100|NCT02161016|E1|Reported Event|map3 Allogeneic Bone Graft|"Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.~map3: Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells."
657101|NCT02160990|B3|Baseline|Total|Total of all reporting groups
657102|NCT02160990|B2|Baseline|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657103|NCT02160990|B1|Baseline|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657104|NCT02160990|P2|Participant Flow|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657105|NCT02160990|P1|Participant Flow|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657106|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657107|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657108|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657109|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657110|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657111|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657112|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657113|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657114|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657115|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657116|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657117|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657118|NCT02160990|O2|Outcome|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657119|NCT02160990|O1|Outcome|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657120|NCT02160990|E2|Reported Event|Placebo|Participants randomized to this arm received placebo subcutaneously twice daily for 30 days.
657121|NCT02160990|E1|Reported Event|Exenatide|Participants randomized to this arm received 5 mcg exenatide subcutaneously twice daily for 30 days.
657122|NCT02160977|B3|Baseline|Total|Total of all reporting groups
657123|NCT02160977|B2|Baseline|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
657124|NCT02160977|B1|Baseline|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
657125|NCT02160977|P2|Participant Flow|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
657126|NCT02160977|P1|Participant Flow|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
657127|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
657128|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
657129|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
657130|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
657131|NCT02160977|O2|Outcome|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
657132|NCT02160977|O1|Outcome|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
657133|NCT02160977|E2|Reported Event|QS-TKA|"patients underwent minimally invasive surgery quadriceps sparing total knee arthroplasty (MIS-QS TKA)~total knee arthroplasty"
657134|NCT02160977|E1|Reported Event|MIS-TKA|"patients underwent minimally invasive surgery total knee arthroplasty (MIS TKA)~total knee arthroplasty"
657135|NCT02160873|B3|Baseline|Total|Total of all reporting groups
657136|NCT02160873|B2|Baseline|Flavor-matched Placebo, Then Chocolate Milk|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then chocolate milk 7-8 hours prior to exercise trial.
657137|NCT02160873|B1|Baseline|Chocolate Milk First, Then Placebo|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before) followed by a 7-day washout, then placebo 7-8 hours prior to exercise trial.
657138|NCT02160873|P2|Participant Flow|Flavor-matched Placebo, Then Chocolate Milk.|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
657139|NCT02160873|P1|Participant Flow|Chocolate Milk, Then Placebo|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
657140|NCT02160873|O2|Outcome|Flavor-matched Placebo|Subjects received flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received 12 oz of chocolate milk 7-8 hours prior to exercise.
657141|NCT02160873|O1|Outcome|Chocolate Milk|Subjects received chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before). Thereafter, there was a 7 day washout period. Then, subjects received the placebo beverage 7-8 hours prior to the exercise trial.
657142|NCT02160873|O2|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo~flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
657143|NCT02160873|O1|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk~chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
657144|NCT02160873|O2|Outcome|Flavor-matched Placebo|"In this arm, subjects receive a flavor-matched placebo (in a cross-over design)~flavor-matched placebo: 12 oz, non-caloric flavor-matched placebo"
657254|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657145|NCT02160873|O1|Outcome|Chocolate Milk|"In this arm, subjects receive chocolate milk (in a cross-over design)~chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)"
657146|NCT02160873|O2|Outcome|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
657147|NCT02160873|O1|Outcome|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
657148|NCT02160873|E2|Reported Event|Flavor-matched Placebo|flavor-matched placebo: 12 oz, 7-8 hours prior to exercise trial (night before)
657149|NCT02160873|E1|Reported Event|Chocolate Milk|chocolate milk: 12 oz, 7-8 hours prior to exercise trial (night before)
657150|NCT02160314|B3|Baseline|Total|Total of all reporting groups
657151|NCT02160314|B2|Baseline|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
657152|NCT02160314|B1|Baseline|Pad Control|"absorbent pad control~Absorbent pad"
657153|NCT02160314|P2|Participant Flow|Pessary|pessary: disposable, single-use
657154|NCT02160314|P1|Participant Flow|Pad Control|absorbent pad control
657155|NCT02160314|O2|Outcome|Pessary|"disposable, single-use pessary~pessary: disposable, single-use pessary"
657156|NCT02160314|O1|Outcome|Pad Control|"absorbent pad control~Absorbent pad"
657157|NCT02160314|E2|Reported Event|Pessary|disposable, single-use pessary
657158|NCT02160314|E1|Reported Event|Pad Control|absorbent pad control
657159|NCT02159950|B3|Baseline|Total|Total of all reporting groups
657160|NCT02159950|B2|Baseline|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657161|NCT02159950|B1|Baseline|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657162|NCT02159950|P2|Participant Flow|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657163|NCT02159950|P1|Participant Flow|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657164|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657165|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657221|NCT02159547|E2|Reported Event|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
657166|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657167|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657168|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657169|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657170|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657171|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657172|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657173|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657255|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657174|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657175|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657176|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657177|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657178|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657179|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657180|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657181|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657182|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657183|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657184|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657185|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657186|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657187|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657188|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657189|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657190|NCT02159950|O2|Outcome|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657191|NCT02159950|O1|Outcome|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657192|NCT02159950|E2|Reported Event|Arm II (Tasquinimod, Sipuleucel-T)|"Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV~Tasquinimod: Given PO"
657256|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
658037|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
657193|NCT02159950|E1|Reported Event|Arm I (Sipuleucel-T)|"Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Sipuleucel-T: Given IV"
657194|NCT02159859|B1|Baseline|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657195|NCT02159859|P1|Participant Flow|Ertapenem|"Subjects with end stage renal disease (ESRD) who undergo hemodialysis three times a week and without infection will be administered one gram of ertapenem once over five minutes through infusion access after a hemodialysis session, and will have blood drawn at time 0, 0.5, 1, 2, 6, and 12 hours after the ertapenem administration and once prior to the next hemodialysis session~Ertapenem: Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn"
657196|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657197|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657198|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657199|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657200|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657201|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657202|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657203|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657204|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657205|NCT02159859|O1|Outcome|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657206|NCT02159859|E1|Reported Event|Ertapenem|Pharmacokinetics and Optimal Dose of Ertapenem in Hemodialysis Patients
657207|NCT02159768|B1|Baseline|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
657208|NCT02159768|P1|Participant Flow|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
657209|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
657210|NCT02159768|O1|Outcome|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
657211|NCT02159768|E1|Reported Event|Airtraq Visualization|"Larynx visualization with Airtraq and attached handphone~Airtraq visualization: Larynx visualization with Airtraq and attached handphone"
657212|NCT02159547|B3|Baseline|Total|Total of all reporting groups
657213|NCT02159547|B2|Baseline|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
657214|NCT02159547|B1|Baseline|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
657215|NCT02159547|P2|Participant Flow|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
657216|NCT02159547|P1|Participant Flow|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
657217|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
657218|NCT02159547|O1|Outcome|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
657219|NCT02159547|O2|Outcome|Normal Slaline|"50 ml normal saline~Normal Saline: 50 ml normal saline"
657220|NCT02159547|O1|Outcome|Dexketoprofen|50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.
657222|NCT02159547|E1|Reported Event|Dexketoprofen|"50 mg intravenous dexketoprofen in 50 ml normal saline in 5 minutes infusion.~Dexketoprofen: 50 mg intravenous arveles in 50 ml saline in 5 minutes"
657223|NCT02159482|B1|Baseline|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
657224|NCT02159482|P1|Participant Flow|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
657225|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
657226|NCT02159482|O1|Outcome|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
657227|NCT02159482|E1|Reported Event|Interferon-alfa-2a|"Starting within 6 months after completion of the dendritic cell vaccine, a dose of interferon alfa-2a will be administered subcutaneously in the skin of the arm, thigh or abdomen every other day for a total of 6 injections.~Interferon Alfa-2a"
657228|NCT02159365|B1|Baseline|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
657321|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657322|NCT02159040|E1|Reported Event|Azacitidine|75mg/m2 7days/28 day cycle
657229|NCT02159365|P1|Participant Flow|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
657230|NCT02159365|O1|Outcome|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
657231|NCT02159365|E1|Reported Event|E-Ld|"E-Ld refers to the combination of Elotuzumab with Lenalidomide/Dexamethasone.~During cycles 1 and 2, elotuzumab was provided weekly as a intravenous 10 mg/kg solution on days 1, 8, 15, and 22. During cycles 3 and beyond, elotuzumab was provided every other week on days 1 and 15.~During each cycle, Lenalidomide was provided as a 25 mg tablet by mouth on days 1-21 and Dexamethasone at a dose of 40 mg/week was administered orally on weeks without elotuzumab infusion. On weeks of elotuzumab infusion, 28 mg was to be administered orally and 8 mg was administered intravenously as part of elotuzumab premedication regimen until progression or discontinuation of Elotuzumab.~A cycle was defined as 28 days. Treatment with study drug continued until disease progression, unacceptable toxicity, or subject met other criteria for discontinuation of study drugs."
657232|NCT02159352|B3|Baseline|Total|Total of all reporting groups
657233|NCT02159352|B2|Baseline|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657234|NCT02159352|B1|Baseline|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657235|NCT02159352|P2|Participant Flow|Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657236|NCT02159352|P1|Participant Flow|Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657237|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657238|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657239|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657240|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657241|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
657242|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657243|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657244|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657245|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
657246|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657247|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and 100-mg ritonavir capsule once daily on Days 5 through 14.
657248|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657249|NCT02159352|O2|Outcome|Group 2: Daclatasvir + Lopinavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily, along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657250|NCT02159352|O1|Outcome|Group 1: Daclatasvir + Darunavir/Ritonavir|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657251|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 -mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657252|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657253|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657257|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657258|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657259|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
657260|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
657261|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657262|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657263|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657264|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received 60 mg of daclatasvir tablet once daily from Day 1 through 4.
657265|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657266|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657267|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily on Days 5 through 14.
657268|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657269|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657270|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657271|NCT02159352|O4|Outcome|Daclatasvir (30 mg) + Lopinavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
657272|NCT02159352|O3|Outcome|Daclatasvir (60 mg) Days 5-14|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
657273|NCT02159352|O2|Outcome|Daclatasvir (30 mg) + Darunavir/Ritonavir Days 5-14|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657274|NCT02159352|O1|Outcome|Daclatasvir (60 mg) Days 1-4|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657275|NCT02159352|O4|Outcome|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/50-mg ritonavir tablets twice daily Days 5 through 14.
657276|NCT02159352|O3|Outcome|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 5 through 14.
657277|NCT02159352|O2|Outcome|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily, along with an 800-mg darunavir tablet, and a 100-mg ritonavir capsule once daily on Days 5 through 14.
657278|NCT02159352|O1|Outcome|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657279|NCT02159352|E6|Reported Event|Group 2: Daclatasvir (30 mg) + Lopinavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with 2 200-mg lopinavir/ 50-mg ritonavir tablets twice daily on Days 5 through 14.
657280|NCT02159352|E5|Reported Event|Group 2: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657281|NCT02159352|E4|Reported Event|Group 2: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100­-mg ritonavir capsule once daily on Days 5 through 14.
657282|NCT02159352|E3|Reported Event|Group 1: Daclatasvir (30 mg) + Darunavir/Ritonavir|Participants received a 30-mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
657283|NCT02159352|E2|Reported Event|Group 1: Daclatasvir (60 mg)|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4.
657284|NCT02159352|E1|Reported Event|Group 1: Total|Participants received a 60-mg daclatasvir tablet once daily on Days 1 through 4 and 30 mg daclatasvir tablet once daily along with an 800-mg darunavir tablet and a 100-mg of ritonavir capsule once daily on Days 5 through 14.
657285|NCT02159118|B3|Baseline|Total|Total of all reporting groups
657286|NCT02159118|B2|Baseline|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657287|NCT02159118|B1|Baseline|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657288|NCT02159118|P2|Participant Flow|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657289|NCT02159118|P1|Participant Flow|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657363|NCT02158247|E2|Reported Event|Touch and Read Group(Female)|female
657400|NCT02157883|P1|Participant Flow|AZD9291 Alone,AZD9291+Itraconozole|Sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole.
657290|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657291|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657292|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657293|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657294|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657295|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657296|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657297|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657298|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657299|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657300|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657301|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657302|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657303|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657376|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657304|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657305|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657306|NCT02159118|O2|Outcome|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657307|NCT02159118|O1|Outcome|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657308|NCT02159118|E2|Reported Event|Powered Bone Marrow Aspiration and Biopsy Procedure|"Powered bone marrow aspiration and biopsy device~Powered bone marrow aspiration and biopsy device: Use of the powered bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657309|NCT02159118|E1|Reported Event|Manual Bone Marrow Aspiration and Biopsy Procedure|"Manual bone marrow aspiration and biopsy device~Manual bone marrow aspiration and biopsy device: Use of the manual bone marrow aspiration and biopsy device to collect one bone marrow aspiration and bone marrow biopsy specimen."
657310|NCT02159040|B1|Baseline|Azacitidine|75mg/m2 7days/28 day cycle
657311|NCT02159040|P1|Participant Flow|Azacitidine|75mg/m2 7days/28 day cycle
657312|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657313|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657314|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657315|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657316|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657317|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657318|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657319|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657320|NCT02159040|O1|Outcome|Azacitidine|75mg/m2 7days/28 day cycle
657323|NCT02158728|B1|Baseline|ICD Indicated Subjects|Subjects indicated for implantable cardioverter defibrillator (ICD)/cardiac resynchronization therapy defibrillator (CRT-D) implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-Invasive ElectroPhysiology Study [NIPS]).
657324|NCT02158728|P1|Participant Flow|ICD Indicated Subjects|"Subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or electrophysiology (EP) study (including Non-invasive EP study [NIPS])~ICD: implantable cardioverter defibrillator CRT-D: cardiac resynchronization therapy defibrillator"
657325|NCT02158728|O1|Outcome|ICD Indicated Subjects|From the initially 80 enrolled subjects indicated for ICD/CRT-D implant, ICD/CRT-D change-out, or indicated for an ICD/CRT-D and undergoing ablation or EP study (including Non-invasive EP Study [NIPS]), 53 subjects provided SVT episode data which qualified for developing and testing new sensing and detection algorithms for a new MedtronicICD. SVT episodes with a ventricular response rate of ≥170 BPM are required in the development of the algorithms.
657326|NCT02158728|E1|Reported Event|ICD Indicated Subjects|Only ICD-indicated subjects undergoing standard ICD/CRT-D implant, ICD/CRT-D change-out, ablation, electrophysiology (EP) study or Non Invasive Programmed Stimulation (NIPS), and who provided a dataset which qualified for developing and testing the sensing and detection algorithms of the new ICD, are included in the analyses.
657327|NCT02158442|B3|Baseline|Total|Total of all reporting groups
657328|NCT02158442|B2|Baseline|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
657329|NCT02158442|B1|Baseline|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
657330|NCT02158442|P2|Participant Flow|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
657331|NCT02158442|P1|Participant Flow|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
657332|NCT02158442|O2|Outcome|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
657333|NCT02158442|O1|Outcome|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
657334|NCT02158442|E2|Reported Event|Control Group|The Control Group received standard dosings of intravenous Timentin plus other standard care.
657335|NCT02158442|E1|Reported Event|Treatment Group|The Treatment Group received intravenous Timentin prior to their PILP procedure.
657336|NCT02158273|B3|Baseline|Total|Total of all reporting groups
657337|NCT02158273|B2|Baseline|Placebo|Matched Placebo
657338|NCT02158273|B1|Baseline|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
657339|NCT02158273|P2|Participant Flow|Placebo|Matched Placebo
657340|NCT02158273|P1|Participant Flow|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
657341|NCT02158273|O2|Outcome|Placebo|Matched Placebo
657342|NCT02158273|O1|Outcome|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
657343|NCT02158273|O2|Outcome|Placebo|Matched Placebo
657344|NCT02158273|O1|Outcome|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
657345|NCT02158273|E2|Reported Event|Placebo|Matched Placebo
657346|NCT02158273|E1|Reported Event|Fenofibrate|TRICOR (fenofibrate): 145 mg/day, oral pill, 9 days
657347|NCT02158247|B3|Baseline|Total|Total of all reporting groups
657348|NCT02158247|B2|Baseline|Touch and Read Group(Female)|female
657377|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
658009|NCT02153398|P5|Participant Flow|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
657349|NCT02158247|B1|Baseline|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
657350|NCT02158247|P1|Participant Flow|Tough and Read Group|"This is a virtual experiment based on the anthropometry of the airway length. Conventional group : We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
657351|NCT02158247|O1|Outcome|Female Airway Length vs Height|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
657352|NCT02158247|O1|Outcome|Airway Length vs Height in Male|"Relationship between airway length and their height are analyzed with linear regression.~Airway length is defined the distance from mouth angle to carina. Additionally it is divided into three parts, from mouth angle to epiglottis tip, epiglottis tip to vocal cords and vocal cords to carina."
657353|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Female|
657354|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Female|
657355|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Female|
657356|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Female|
657357|NCT02158247|O2|Outcome|Touch and Read for Normal Group of Male|
657358|NCT02158247|O1|Outcome|Conventional Method for Normal Group of Male|
657359|NCT02158247|O2|Outcome|Touch and Read for Risk Group of Male|
657360|NCT02158247|O1|Outcome|Conventional Method for Risk Group of Male|
657361|NCT02158247|O2|Outcome|Airway Length of Female|
657362|NCT02158247|O1|Outcome|Airway Length for Male|
657364|NCT02158247|E1|Reported Event|Touch and Read Group(Male)|"This is a virtual experiment based on the anthropometry of the airway length. We defined the conventional group as patients who are intubated on the depth of 25cm for male and 23 cm fo female from the medial incisor virtually.~Touch and read group : Depth of intubation was determined on the measurement of the airway length of each patient. In touch and read group, the depth of intubation was determined by the sum of the length from the mouth angle to epiglottis tip, the length from the epiglottis tip to vocal cords and 8cm for the endotracheal tube #7.0. Length from the mouth angle to epiglottis tip is determined at the time of intubation with specially scaled endotracheal tube."
657365|NCT02158039|B1|Baseline|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
657366|NCT02158039|P1|Participant Flow|Pancreatic Cyst Ethanol Injection|Endoscopic ultrasound (EUS)-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
657367|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
657368|NCT02158039|O1|Outcome|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
657369|NCT02158039|E1|Reported Event|Pancreatic Cyst Ethanol Injection|EUS-guided lavage of a pancreatic cyst with ethanol solution. The ethanol solution was diluted to 80% using normal saline. Final solution also contained 1% lidocaine except in patients allergic to local anesthetics. The ethanol solution was injected into pancreatic cysts at a volume equal to 90% of the aspirated cyst volume. In subjects undergoing re-treatment of a cyst, ethanol was diluted to 90% using normal saline, and injected in a volume equal to 100% of the aspirated cyst volume.
657370|NCT02157935|B3|Baseline|Total|Total of all reporting groups
657371|NCT02157935|B2|Baseline|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
657372|NCT02157935|B1|Baseline|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657373|NCT02157935|P2|Participant Flow|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
657374|NCT02157935|P1|Participant Flow|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657375|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
657378|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657379|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
657380|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657381|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
657382|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657383|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
657384|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657385|NCT02157935|O2|Outcome|Formoterol Turbuhaler|Formoterol Turbuhaler, 4.5 μg x 2 actuations BID, for oral inhalation
657386|NCT02157935|O1|Outcome|Symbicort pMDI|Symbicort pMDI, budesonide/formoterol, 160/4.5 μg x 2 actuations BID, for oral inhalation
657387|NCT02157935|E2|Reported Event|Symbicort 160/4.5 ug x2 Bid|
657388|NCT02157935|E1|Reported Event|Formoterol 4.5 ug x2 Bid|
657389|NCT02157909|B3|Baseline|Total|Total of all reporting groups
657390|NCT02157909|B2|Baseline|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
657391|NCT02157909|B1|Baseline|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
657392|NCT02157909|P2|Participant Flow|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
657393|NCT02157909|P1|Participant Flow|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
657394|NCT02157909|O2|Outcome|AOA Sphere|Sphere contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
657395|NCT02157909|O1|Outcome|AOA Modified|Modified design contact lenses worn at least 8 hours per day, 5 days per week on a daily wear basis for 7 days
657396|NCT02157909|E3|Reported Event|AOA Sphere|Includes all subjects / eyes exposed to AOA Sphere lenses
657397|NCT02157909|E2|Reported Event|AOA Modified|Includes all subjects / eyes exposed to AOA Modified lenses
657398|NCT02157909|E1|Reported Event|Pre-treatment|Includes all subjects / eyes prior to the exposure to the investigational or control products
657399|NCT02157883|B1|Baseline|AZD9291 Alone,AZD9291+Itraconozole|Sequential treatments of AZD9291 alone (including a washout) followed by AZD9291+itraconazole.
669380|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
657401|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657402|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657403|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657404|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657405|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657406|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657407|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657408|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657409|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657410|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657411|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657412|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657413|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657414|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657415|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657416|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657417|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657418|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657419|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657420|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657421|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657422|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657423|NCT02157883|O2|Outcome|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657424|NCT02157883|O1|Outcome|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657425|NCT02157883|E3|Reported Event|Overall|AZD9291 in Period 1 and AZD9291 + itrazonazole in Period 2
657426|NCT02157883|E2|Reported Event|AZD9291+Itraconazole|Single oral dose 80mg AZD9291 on Day 10, itraconazole 200mg twice daily dosing on Days 6-18
657427|NCT02157883|E1|Reported Event|AZD9291 Alone|Single oral dose of 80mg AZD9291 on Day 1
657428|NCT02157623|B3|Baseline|Total|Total of all reporting groups
657429|NCT02157623|B2|Baseline|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
657473|NCT02157116|E1|Reported Event|Treated Patients|Due to insufficient accrual, adverse event data was not analyzed.
657430|NCT02157623|B1|Baseline|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
657431|NCT02157623|P2|Participant Flow|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
657432|NCT02157623|P1|Participant Flow|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
657433|NCT02157623|O2|Outcome|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
657434|NCT02157623|O1|Outcome|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
657435|NCT02157623|E2|Reported Event|Blue Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with blue light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Blue Light Photodynamic Therapy: Blu-U® (blue lamp) after Levulan application on randomized treatment field"
657436|NCT02157623|E1|Reported Event|Red Light Photodynamic Therapy|"Subject will be randomized to right or left side and assigned side will be treated with red light PDT after Levulan application~Levulan: Levulan application followed by Red or Blue light PDT on randomized treatment fields~Red Light Photodynamic Therapy: Aktilite™ (red lamp) after Levulan application on randomized treatment field"
657437|NCT02157376|B3|Baseline|Total|Total of all reporting groups
657438|NCT02157376|B2|Baseline|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
657439|NCT02157376|B1|Baseline|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
658038|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
657440|NCT02157376|P2|Participant Flow|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
657441|NCT02157376|P1|Participant Flow|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
657442|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
657443|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
657444|NCT02157376|O2|Outcome|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
657445|NCT02157376|O1|Outcome|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
657446|NCT02157376|E2|Reported Event|Esomeprazole|iv Esomeprazole 40 mg bid 30 min intermittent infusion given for maximum 14 days
657447|NCT02157376|E1|Reported Event|Cimetidine|iv Cimetidine 300 mg 30 min bolus infusion, followed by iv Cimetidine continuous infusion (50 mg/h) given for maximum 14 days
657448|NCT02157298|B3|Baseline|Total|Total of all reporting groups
657449|NCT02157298|B2|Baseline|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657450|NCT02157298|B1|Baseline|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657451|NCT02157298|P2|Participant Flow|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657452|NCT02157298|P1|Participant Flow|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657453|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657454|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657455|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657456|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657457|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657458|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657459|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657460|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657461|NCT02157298|O2|Outcome|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657462|NCT02157298|O1|Outcome|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657463|NCT02157298|E2|Reported Event|Placebo|Placebo plus insulin alone or in combination with DPP-4 inhibitor
657464|NCT02157298|E1|Reported Event|Dapagliflozin|Dapagliflozin 5 mg plus insulin alone or in combination with DPP-4 inhibitor
657465|NCT02157116|B1|Baseline|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
657466|NCT02157116|P1|Participant Flow|All Subjects|All subjects who signed a consent form are included, whether or not they received treatment as a part of the study.
657467|NCT02157116|O1|Outcome|Treated Patients|
657468|NCT02157116|O1|Outcome|Treated Patients|
657469|NCT02157116|O1|Outcome|Treated Patients|
657470|NCT02157116|O1|Outcome|Treated Patients|
657471|NCT02157116|O1|Outcome|Treated Patients|
657472|NCT02157116|O1|Outcome|Treated Patients|
657475|NCT02156466|B5|Baseline|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657476|NCT02156466|B4|Baseline|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657477|NCT02156466|B3|Baseline|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657478|NCT02156466|B2|Baseline|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657479|NCT02156466|B1|Baseline|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657480|NCT02156466|P5|Participant Flow|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657481|NCT02156466|P4|Participant Flow|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657482|NCT02156466|P3|Participant Flow|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657483|NCT02156466|P2|Participant Flow|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657484|NCT02156466|P1|Participant Flow|MSB0010841 30 mg|MSB0010841 (Anti-Interleukin [IL]-17A/F Nanobody) was administered at a dose of 30 milligram (mg) as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657485|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657486|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657487|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657488|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657489|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657490|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657491|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657492|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657493|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657494|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657495|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week for a total duration of 6 weeks.
657496|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week for a total duration of 6 weeks.
657497|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week for a total duration of 6 weeks.
657498|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week for a total duration of 6 weeks.
657499|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 was administered at a dose of 30 mg as SC injection every other week for a total duration of 6 weeks.
657500|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657501|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657502|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657503|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657504|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657505|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657506|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657507|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657508|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657509|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657510|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657511|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657512|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657513|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657514|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657515|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657516|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657517|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657518|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657519|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657520|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657521|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657522|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657523|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657524|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657525|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657526|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657527|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657528|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657529|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657530|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657531|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657532|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657533|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657534|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657535|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657536|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657537|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657538|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657539|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657540|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657541|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657542|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657543|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657544|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657545|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657546|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657547|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657548|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657549|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657550|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657551|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657552|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657553|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657554|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657555|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657556|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657557|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657558|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657559|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657560|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657561|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657562|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657563|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657564|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657565|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657566|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657567|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657568|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657569|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657570|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657571|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657572|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657573|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657574|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657575|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657576|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657577|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657578|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657579|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657580|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657581|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657582|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657583|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657584|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657585|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657586|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657587|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657588|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657589|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657590|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657591|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657592|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657593|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657594|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657595|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657596|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657597|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657598|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657599|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657600|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657601|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657602|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657603|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657604|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657605|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657606|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657607|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657608|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657609|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657610|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657611|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657612|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657613|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657614|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657615|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657616|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657617|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657618|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657619|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657620|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657621|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657622|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657623|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657624|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657625|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657626|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657627|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657628|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657629|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657630|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657631|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657632|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657633|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657634|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657635|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657636|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657637|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657638|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
657639|NCT02156466|O1|Outcome|ADA Positive Subjects|All subjects who received placebo or MSB0010841 (30 mg, 60 mg, 90 mg or 240 mg) and had positive ADA titers before and/or after study drug administration.
657640|NCT02156466|O2|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657641|NCT02156466|O1|Outcome|MSB0010841 Combined|All subjects who received MSB0010841 (Anti-IL-17A/F Nanobody) at a dose of 30 mg, 60 mg, 120 mg or 240 mg as subcutaneous (SC) injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks
657642|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657643|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657644|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657645|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657646|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657647|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657648|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657649|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657650|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657651|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657652|NCT02156466|O5|Outcome|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657653|NCT02156466|O4|Outcome|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657654|NCT02156466|O3|Outcome|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
658010|NCT02153398|P4|Participant Flow|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
657655|NCT02156466|O2|Outcome|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657656|NCT02156466|O1|Outcome|MSB0010841 30 mg|MSB0010841 (Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657657|NCT02156466|E5|Reported Event|Placebo|Placebo matched to MSB0010841 was administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657658|NCT02156466|E4|Reported Event|MSB0010841 240 mg|MSB0010841 was administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657659|NCT02156466|E3|Reported Event|MSB0010841 120 mg|MSB0010841 was administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657660|NCT02156466|E2|Reported Event|MSB0010841 60 mg|MSB0010841 was administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657661|NCT02156466|E1|Reported Event|MSB0010841 30 mg|MSB0010841(Anti- IL-17A/F Nanobody) was administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
657662|NCT02156271|B3|Baseline|Total|Total of all reporting groups
657663|NCT02156271|B2|Baseline|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657664|NCT02156271|B1|Baseline|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657665|NCT02156271|P2|Participant Flow|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657666|NCT02156271|P1|Participant Flow|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657667|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657668|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657669|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657670|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657671|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657672|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657673|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657674|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657675|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657676|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657677|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657678|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657679|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657680|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657681|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657682|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657683|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657684|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657685|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657686|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657687|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657688|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657689|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657690|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657691|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657692|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657693|NCT02156271|O2|Outcome|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
657694|NCT02156271|O1|Outcome|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657695|NCT02156271|E2|Reported Event|Placebo|"15 subjects will be randomized to receive the placebo~placebo"
658011|NCT02153398|P3|Participant Flow|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
657696|NCT02156271|E1|Reported Event|Ramelteon|"Subjects will take ramelteon 8mg one time daily 30 minutes before bedtime with approximately 8 ounces of water. Subjects have a 2 out of 3 chance of receiving ramelteon.~ramelteon"
657697|NCT02156167|B1|Baseline|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
657698|NCT02156167|P1|Participant Flow|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
657699|NCT02156167|O1|Outcome|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
657700|NCT02156167|E1|Reported Event|CP810|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked)
657701|NCT02155985|B4|Baseline|Total|Total of all reporting groups
657702|NCT02155985|B3|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657703|NCT02155985|B2|Baseline|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657704|NCT02155985|B1|Baseline|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657705|NCT02155985|P3|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657706|NCT02155985|P2|Participant Flow|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657707|NCT02155985|P1|Participant Flow|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657777|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
658039|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
657708|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657709|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657710|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657711|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657712|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657713|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657714|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657715|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657716|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657717|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657718|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657719|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657720|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657721|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657722|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657723|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657724|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657725|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657726|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657727|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657728|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657729|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657778|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
669381|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
657730|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657731|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657732|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657733|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657734|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657735|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657736|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657737|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657738|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657739|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657740|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657741|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657742|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657743|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657863|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657744|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657745|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657746|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657747|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657748|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657749|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657750|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657751|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657752|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657753|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657754|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657755|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657756|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657757|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657758|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657759|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657760|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657761|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657762|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657763|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657764|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657765|NCT02155985|O3|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657864|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657766|NCT02155985|O2|Outcome|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657767|NCT02155985|O1|Outcome|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657768|NCT02155985|E3|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebos|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study products tablets to allow for a 4-week washout period.~Placebo for aspirin"
657769|NCT02155985|E2|Reported Event|Aspirin 100 mg + Aspirin 300 mg Placebo|"At week 0, participants were prescribed a placebo for aspirin 300 mg (one tablet) and aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657770|NCT02155985|E1|Reported Event|Aspirin 300 mg + Aspirin 100 mg Placebo|"At week 0, participants were prescribed aspirin 300 mg (one tablet) and placebo for aspirin 100 mg (one tablet) once daily. At week 12, participants were to stop both study product tablets to allow for a 4-week washout period.~Aspirin~Placebo for aspirin"
657771|NCT02155881|B3|Baseline|Total|Total of all reporting groups
657772|NCT02155881|B2|Baseline|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657773|NCT02155881|B1|Baseline|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657774|NCT02155881|P2|Participant Flow|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657775|NCT02155881|P1|Participant Flow|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657776|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
669382|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
657779|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657780|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657781|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657782|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657783|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657784|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657785|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657786|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657787|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657788|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657789|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657790|NCT02155881|O2|Outcome|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657791|NCT02155881|O1|Outcome|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657792|NCT02155881|E2|Reported Event|Placebo|Ciclesonide placebo-matching puffs, 2 puffs per nostril, nasal spray, once daily for up to 14 days.
657793|NCT02155881|E1|Reported Event|Ciclesonide 200 mcg|Ciclesonide 200 mcg, 2 puffs per nostril (50 mcg/puff), nasal spray, once daily for up to 14 days.
657794|NCT02155543|B8|Baseline|Total|Total of all reporting groups
657795|NCT02155543|B7|Baseline|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
657796|NCT02155543|B6|Baseline|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
657797|NCT02155543|B5|Baseline|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
657798|NCT02155543|B4|Baseline|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
657799|NCT02155543|B3|Baseline|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
657800|NCT02155543|B2|Baseline|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
657801|NCT02155543|B1|Baseline|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
658006|NCT02153398|B3|Baseline|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
657802|NCT02155543|P7|Participant Flow|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
657803|NCT02155543|P6|Participant Flow|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
657804|NCT02155543|P5|Participant Flow|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
657805|NCT02155543|P4|Participant Flow|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
657806|NCT02155543|P3|Participant Flow|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
657807|NCT02155543|P2|Participant Flow|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
657808|NCT02155543|P1|Participant Flow|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
657809|NCT02155543|O4|Outcome|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
657810|NCT02155543|O3|Outcome|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
657902|NCT02154139|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
657811|NCT02155543|O2|Outcome|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
657812|NCT02155543|O1|Outcome|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
657813|NCT02155543|E7|Reported Event|Cohort 1: AGN-223575 Form A/Vehicle|One drop of AGN-223575 Formulation A in the study eye and one drop of AGN-223575 vehicle in the other eye on day 1, followed by one drop of AGN-223575 Formulation A twice daily in the study eye and 1 drop of AGN-223575 vehicle in the other eye twice daily for 6 days.
657814|NCT02155543|E6|Reported Event|AGN-223575 Vehicle BID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle twice daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
657815|NCT02155543|E5|Reported Event|AGN-223575 Vehicle TID|One drop of AGN-223575 vehicle in both eyes on day 1, followed by one drop of AGN-223575 vehicle three times daily in both eyes for 13 days, and a single drop of AGN-223575 vehicle in both eyes on day 15.
657816|NCT02155543|E4|Reported Event|Cohort 2: AGN-223575 Formulation A BID|One drop of AGN-223575 Formulation A in both eyes on day 1, followed by one drop of AGN-223575 Formulation A twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation A in both eyes on day 15.
657817|NCT02155543|E3|Reported Event|Cohort 3: AGN-223575 Formulation B BID|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
657818|NCT02155543|E2|Reported Event|Cohort 4: AGN-223575 Formulation C BID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
657819|NCT02155543|E1|Reported Event|Cohort 5: AGN-223575 Formulation C TID|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C three times daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
657820|NCT02155335|B1|Baseline|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
657821|NCT02155335|P2|Participant Flow|Smartject™ Device→ Prefilled Syringe|Golimumab 50 mg supplied in a Smartject administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied a prefilled syringe 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
657822|NCT02155335|P1|Participant Flow|Prefilled Syringe→Smartject™ Device|Golimumab 50 mg supplied in a prefilled syringe administered 2 times (once by the treating physician and then by the participant under the supervision of the treating physician). Participant than is administered Golimumab 50 mg supplied in the Smartject 2 times, first by the physician and then by the participant. Participants receive a total of 200 mg of golimumbab.
657823|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
657824|NCT02155335|O1|Outcome|Per Protocl Set (PPS)|All enrolled participants who met all inclusion and none of the exclusion criteria, received all four injections of golimumab according to the protocol, and completed the device preference questionnaire.
657825|NCT02155335|E1|Reported Event|All Treated Participants|All participants who received at least 1 injection from either prefilled syringe or Smartject
657826|NCT02155322|B1|Baseline|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
658007|NCT02153398|B2|Baseline|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
657827|NCT02155322|P1|Participant Flow|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
657828|NCT02155322|O1|Outcome|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
657829|NCT02155322|O1|Outcome|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
657830|NCT02155322|E1|Reported Event|PEG-IFN|Participants received PEG-IFN 6 μg/kg subcutaneously (SC) once weekly during an 8-week induction phase followed by 3 μg/kg SC once weekly for a 42-week maintenance phase (treatment up to approximately 1 year).
657831|NCT02155283|B1|Baseline|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
657832|NCT02155283|P1|Participant Flow|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
657833|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
657834|NCT02155283|O1|Outcome|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
657835|NCT02155283|E1|Reported Event|Treatment Continuous Passive Motion|"Single-arm; 3-week treatment plan using Kyrobak compared to baseline (before treatment)~Continuous Passive Motion: Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day"
657836|NCT02155010|B3|Baseline|Total|Total of all reporting groups
658040|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
657837|NCT02155010|B2|Baseline|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
657838|NCT02155010|B1|Baseline|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
657839|NCT02155010|P2|Participant Flow|Dexmedetomidine After Bupivacaine|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
657840|NCT02155010|P1|Participant Flow|Dexmedetomidine Before Bupivacaine|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
657841|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
657842|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
657843|NCT02155010|O2|Outcome|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
657844|NCT02155010|O1|Outcome|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
657845|NCT02155010|E2|Reported Event|After Spinal Anesthesia|"IV dexmedetomidine infusion after intrathecal injection of heavy bupivacaine~Dexmedetomidine with heavy bupivacaine: Dexmedetomidine infusion after IT of heavy bupivacaine"
657846|NCT02155010|E1|Reported Event|Before Spinal Anesthesia|"IV dexmedetomidine infusion before intrathecal injection of heavy bupivacaine~Dexmedetomidine: Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine"
657847|NCT02154906|B3|Baseline|Total|Total of all reporting groups
657848|NCT02154906|B2|Baseline|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
657849|NCT02154906|B1|Baseline|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
657850|NCT02154906|P2|Participant Flow|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
657851|NCT02154906|P1|Participant Flow|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
657852|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
657853|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
657854|NCT02154906|O2|Outcome|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
657855|NCT02154906|O1|Outcome|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
657856|NCT02154906|E2|Reported Event|Autologous Platelet Rich Fibrin|"autologous platelet rich fibrin used to graft intrabony defect~autologous platelet rich fibrin"
657857|NCT02154906|E1|Reported Event|DFDBA|"DFDBA used to graft intrabony defect~DFDBA"
657858|NCT02154425|B1|Baseline|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
657859|NCT02154425|P1|Participant Flow|Mothers (SS)|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
657860|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657861|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657862|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657865|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657866|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657867|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657868|NCT02154425|O1|Outcome|All Mothers (PK-PPS)|This arm consisted of all mothers with a valid CZP concentration measurement in breast milk with no important protocol deviations affecting the primary variable.
657869|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657870|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657871|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657872|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657873|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657903|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
657874|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657875|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657876|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657877|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657878|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657879|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657880|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657881|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657882|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657883|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657884|NCT02154425|O2|Outcome|Mothers CZP (PK-PPS) Q4W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 400 mg CZP every 4 weeks (Q4W).
657885|NCT02154425|O1|Outcome|Mothers CZP (PK-PPS) Q2W|This arm consisted of all mothers with a valid Certolizumab Pegol (CZP) concentration measurement in breast milk with no important protocol deviations affecting the primary variable, who were administered 200 mg CZP every 2 weeks (Q2W).
657886|NCT02154425|E2|Reported Event|SS-I|This arm consisted of all infants of mothers in the SS-M.
657887|NCT02154425|E1|Reported Event|SS-M|This arm consisted of all participating mothers who had received at least 1 dose of Certolizumab Pegol (CZP).
657888|NCT02154386|B3|Baseline|Total|Total of all reporting groups
657889|NCT02154386|B2|Baseline|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657890|NCT02154386|B1|Baseline|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657891|NCT02154386|P2|Participant Flow|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657892|NCT02154386|P1|Participant Flow|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
677629|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
657893|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657894|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657895|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657896|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657897|NCT02154386|O2|Outcome|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657898|NCT02154386|O1|Outcome|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657899|NCT02154386|E2|Reported Event|18-20 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 18-20 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657900|NCT02154386|E1|Reported Event|8-10 Week Healing Group|"dental implant placed (and bone core biopsy harvested) 8-10 weeks after tooth extraction/grafting~Ridge preservation using DFDBA: tooth extraction followed by ridge preservation grafting using DFDBA"
657901|NCT02154139|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
658032|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
657904|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
657905|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
657906|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
657907|NCT02154139|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
657908|NCT02154139|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate 11.25 mg, injection subcutaneously once every 12 weeks up to 96 weeks.
657909|NCT02154087|B1|Baseline|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
657910|NCT02154087|P1|Participant Flow|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
657911|NCT02154087|O1|Outcome|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
657912|NCT02154087|E1|Reported Event|HP802-247|"HP802-247: 260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle~HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth-arrested keratinocytes and fibroblasts) applied every 2 weeks, with Vehicle (fibrinogen solution & acellular thrombin solution) on alternate weeks, for up to 12 weeks, or until wound closure occurred, which ever came first"
657913|NCT02154048|B4|Baseline|Total|Total of all reporting groups
657914|NCT02154048|B3|Baseline|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
657915|NCT02154048|B2|Baseline|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
657916|NCT02154048|B1|Baseline|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
657917|NCT02154048|P3|Participant Flow|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
657918|NCT02154048|P2|Participant Flow|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
657919|NCT02154048|P1|Participant Flow|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
678158|NCT01992107|E4|Reported Event|Total|Total number of Subjects
657920|NCT02154048|O3|Outcome|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
657921|NCT02154048|O2|Outcome|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
657922|NCT02154048|O1|Outcome|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
657923|NCT02154048|E3|Reported Event|Additive Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with both 1:400,000 epinephrine and preservative-free dexamethasone 8mg and an IV normal saline placebo injection.~Ropivacaine + Dexamethasone + Placebo"
657924|NCT02154048|E2|Reported Event|Local Anesthetic (LA) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an intravenous (IV) normal saline placebo injection.~Ropivacaine + Placebo"
657925|NCT02154048|E1|Reported Event|Intravenous (IV) Control Group|"This group will be comprised of 20 subjects who will receive an ultrasound-guided supraclavicular brachial plexus block with 30ml of ropivacaine 0.5% with 1:400,000 epinephrine and an IV preservative-free dexamethasone 8 mg injection.~Ropivacaine + Dexamethasone"
657926|NCT02153827|B3|Baseline|Total|Total of all reporting groups
657927|NCT02153827|B2|Baseline|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657928|NCT02153827|B1|Baseline|Eccentric External Rotator Training|"Eccentric Shoulder External Rotator Training~Eccentric Shoulder External Rotator Training"
658033|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
657929|NCT02153827|P2|Participant Flow|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657930|NCT02153827|P1|Participant Flow|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
657931|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657932|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
657933|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657934|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
657935|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657936|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
657937|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657938|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
657939|NCT02153827|O2|Outcome|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657940|NCT02153827|O1|Outcome|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
657941|NCT02153827|E2|Reported Event|General Shoulder Exercise|General Shoulder exercise: general exercise consisting of active shoulder movements
657942|NCT02153827|E1|Reported Event|Eccentric External Rotator Training|Eccentric Shoulder External Rotator Training
657943|NCT02153788|B3|Baseline|Total|Total of all reporting groups
657944|NCT02153788|B2|Baseline|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657945|NCT02153788|B1|Baseline|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657946|NCT02153788|P2|Participant Flow|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657947|NCT02153788|P1|Participant Flow|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657948|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657949|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657950|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657951|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
658008|NCT02153398|B1|Baseline|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
679053|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
657952|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657953|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657954|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657955|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657956|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657957|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657958|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
658034|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
657959|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657960|NCT02153788|O2|Outcome|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657961|NCT02153788|O1|Outcome|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657962|NCT02153788|E2|Reported Event|Placebo|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to placebo will be given placebo for 12 weeks.~Placebo"
657963|NCT02153788|E1|Reported Event|Temazepam|"After screening, all subjects meeting entry criteria will be placed on the same single blind study drug treatment, asked to complete a daily sleep diary, and return one week later. After one week subjects randomized to temazepam will be given temazepam 15 mg for 12 weeks.~Temazepam: Temazepam 15 mg orally at bedtime"
657964|NCT02153489|B1|Baseline|Overall Study|All patients participating in the crossover study
657965|NCT02153489|P2|Participant Flow|Sequence B|Placebo - Aclidinium 400 μg
657966|NCT02153489|P1|Participant Flow|Sequence A|Aclidinium 400 μg - Placebo
657967|NCT02153489|O2|Outcome|Placebo|Placebo BID
657968|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657969|NCT02153489|O2|Outcome|Placebo|Placebo BID
657970|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657971|NCT02153489|O2|Outcome|Placebo|Placebo BID
657972|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657973|NCT02153489|O2|Outcome|Placebo|Placebo BID
657974|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657975|NCT02153489|O2|Outcome|Placebo|Placebo BID
657976|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657977|NCT02153489|O2|Outcome|Placebo|Placebo BID
657978|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657979|NCT02153489|O2|Outcome|Placebo|Placebo BID
657980|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657981|NCT02153489|O2|Outcome|Placebo|Placebo BID
657982|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657983|NCT02153489|O2|Outcome|Placebo|Placebo BID
657984|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657985|NCT02153489|O2|Outcome|Placebo|Placebo BID
657986|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657987|NCT02153489|O2|Outcome|Placebo|Placebo BID
657988|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657989|NCT02153489|O2|Outcome|Placebo|Placebo BID
657990|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657991|NCT02153489|O2|Outcome|Placebo|Placebo BID
657992|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657993|NCT02153489|O2|Outcome|Placebo|Placebo BID
657994|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657995|NCT02153489|O2|Outcome|Placebo|Placebo BID
657996|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657997|NCT02153489|O2|Outcome|Placebo|Placebo BID
657998|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
657999|NCT02153489|O2|Outcome|Placebo|Placebo BID
658000|NCT02153489|O1|Outcome|Aclidinium|Aclidinium 400 μg BID
658001|NCT02153489|E2|Reported Event|Placebo|Placebo BID
658002|NCT02153489|E1|Reported Event|Aclidinium|Aclidinium 400 μg BID
658003|NCT02153398|B6|Baseline|Total|Total of all reporting groups
658004|NCT02153398|B5|Baseline|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658005|NCT02153398|B4|Baseline|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658012|NCT02153398|P2|Participant Flow|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658013|NCT02153398|P1|Participant Flow|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658014|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658015|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658016|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658017|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658018|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658019|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658020|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658021|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658022|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658023|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658024|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658025|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658026|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658027|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658028|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658029|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658030|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658031|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658041|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658042|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658043|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658044|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658045|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658046|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658047|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658048|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658049|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658050|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658051|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658052|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658053|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658054|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658055|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658056|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658057|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658058|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658059|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658060|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658061|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658062|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658063|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658064|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658065|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658066|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658067|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658068|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658069|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658070|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658071|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658072|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658073|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658074|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658075|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658076|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658077|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658078|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658079|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658080|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658081|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658082|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658083|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658084|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658085|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658086|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658087|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658088|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658089|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658090|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658091|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658092|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658093|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658094|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658095|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658096|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658097|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658098|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658099|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658100|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658101|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658102|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658103|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658104|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658105|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
669383|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
658106|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658107|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658108|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658109|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658110|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658111|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658112|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658113|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658114|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658115|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658116|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658117|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658118|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658119|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658120|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658121|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658122|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658123|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658124|NCT02153398|O5|Outcome|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658125|NCT02153398|O4|Outcome|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658126|NCT02153398|O3|Outcome|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658127|NCT02153398|O2|Outcome|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658128|NCT02153398|O1|Outcome|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658129|NCT02153398|E5|Reported Event|Group 5|D961H capsule 20 mg Age: 12-14 years and Weight: ≥20 kg
658130|NCT02153398|E4|Reported Event|Group 4|D961H capsule 10 mg Age: 12-14 years and Weight: ≥20 kg
658131|NCT02153398|E3|Reported Event|Group 3|D961H capsule 20 mg Age: 1-11 years and Weight: ≥20 kg
658132|NCT02153398|E2|Reported Event|Group 2|D961H capsule 10 mg Age: 1-11 years and Weight: ≥20 kg
658133|NCT02153398|E1|Reported Event|Group 1|D961H sachet 10 mg Age: 1-11 years and Weight: <20 kg
658134|NCT02153346|B1|Baseline|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
658135|NCT02153346|P1|Participant Flow|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
658136|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
658137|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
658138|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base. Only participants actively working who completed the questionnaires were included in the analysis of productivity.
658139|NCT02153346|O1|Outcome|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
658140|NCT02153346|E1|Reported Event|BD-Asthma/RESP|Data was collected by an interview, questionnaires and by review of the medical chart from participants who accepted to be registered in the BD-Asthma/RESP data base.
658141|NCT02153099|B8|Baseline|Total|Total of all reporting groups
658142|NCT02153099|B7|Baseline|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
658143|NCT02153099|B6|Baseline|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658144|NCT02153099|B5|Baseline|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658145|NCT02153099|B4|Baseline|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658146|NCT02153099|B3|Baseline|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658147|NCT02153099|B2|Baseline|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658148|NCT02153099|B1|Baseline|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658149|NCT02153099|P7|Participant Flow|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
658150|NCT02153099|P6|Participant Flow|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658151|NCT02153099|P5|Participant Flow|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658152|NCT02153099|P4|Participant Flow|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658153|NCT02153099|P3|Participant Flow|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658154|NCT02153099|P2|Participant Flow|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658155|NCT02153099|P1|Participant Flow|Cohort 4: TAK-058 5 mg|TAK-058 (ENV8058) 5 mg, 100 mL oral solution, once on Day 1.
658156|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658157|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658158|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658159|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658160|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
669384|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
658161|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658162|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658163|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658164|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658165|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658166|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658167|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658168|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658169|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658170|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658171|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658172|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658173|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658174|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658175|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658176|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658177|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658178|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658179|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658180|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
658181|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658182|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658183|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658184|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658185|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658186|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658187|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
658188|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658189|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658190|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658191|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658192|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658193|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658194|NCT02153099|O7|Outcome|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
658195|NCT02153099|O6|Outcome|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658196|NCT02153099|O5|Outcome|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658197|NCT02153099|O4|Outcome|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658198|NCT02153099|O3|Outcome|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658199|NCT02153099|O2|Outcome|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658200|NCT02153099|O1|Outcome|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658201|NCT02153099|E7|Reported Event|Cohort 1-6: Placebo|TAK-058 placebo-matching, 100 mL oral solution, once on Day 1.
658202|NCT02153099|E6|Reported Event|Cohorts 6: TAK-058 150 mg|TAK-058 150 mg, 100 mL oral solution, once on Day 1.
658203|NCT02153099|E5|Reported Event|Cohort 5: TAK-058 75 mg|TAK-058 75 mg, 100 mL oral solution, once on Day 1.
658204|NCT02153099|E4|Reported Event|Cohort 3: TAK-058 45 mg|TAK-058 45 mg, 100 mL oral solution, once on Day 1.
658205|NCT02153099|E3|Reported Event|Cohort 2: TAK-058 30 mg|TAK-058 30 mg, 100 mL oral solution, once on Day 1.
658206|NCT02153099|E2|Reported Event|Cohort 1: TAK-058 15 mg|TAK-058 15 mg, 100 mL oral solution, once on Day 1.
658207|NCT02153099|E1|Reported Event|Cohort 4: TAK-058 5 mg|TAK-058 5 mg, 100 mL oral solution, once on Day 1.
658208|NCT02153086|B1|Baseline|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658209|NCT02153086|P1|Participant Flow|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658210|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658211|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658212|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658213|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658214|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
669390|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
658215|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658216|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658217|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658218|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658219|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658220|NCT02153086|O1|Outcome|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658221|NCT02153086|E1|Reported Event|Ramelteon 8 mg|Participants receiving ramelteon 8 mg, tablet, orally, once as daily clinical practice were observed for up to 6 months. A follow up of 6 months was carried out.
658222|NCT02152605|B3|Baseline|Total|Total of all reporting groups
658223|NCT02152605|B2|Baseline|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658224|NCT02152605|B1|Baseline|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658225|NCT02152605|P2|Participant Flow|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658226|NCT02152605|P1|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658227|NCT02152605|O2|Outcome|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658228|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658318|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
658319|NCT02151994|E18|Reported Event|1200 mg (MAD Period)|MAD period
658229|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658230|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658231|NCT02152605|O2|Outcome|UMEC/VI 62.5/25 mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658232|NCT02152605|O1|Outcome|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658233|NCT02152605|E2|Reported Event|UMEC/VI 62.5/25mcg|Participants with COPD received UMEC/VI 62.5/25mcg via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658234|NCT02152605|E1|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease (COPD) received matching placebo via DPI once daily for 12 weeks. In addition, albuterol/salbutamol was provided to participants to use on an as-needed basis for relief of COPD symptoms throughout the run-in and double-blind treatment periods. Participants were followed up 7 days after the last dose of study medication.
658235|NCT02152566|B1|Baseline|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
658400|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658236|NCT02152566|P1|Participant Flow|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
658237|NCT02152566|O1|Outcome|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
658238|NCT02152566|E1|Reported Event|Diagnostic PSG/PG, PSG w. Nasal High Flow Therapy|"All patients recruited will undergo a diagnostic sleep study, either a full in laboratory attended polysomnography (PSG), or an in-home polygraphy (PG). If respiratory insufficiencies are detected, these patients will undergo an overnight in laboratory attended PSG on a nasal high flow therapy device to test the primary endpoint of this study. Patients without respiratory insufficiencies after the first PSG/PG will take no further part in the trial.~Nasal High flow therapy device: Nasal high flow therapy via nasal cannula."
658239|NCT02152371|B3|Baseline|Total|Total of all reporting groups
658240|NCT02152371|B2|Baseline|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
658241|NCT02152371|B1|Baseline|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
658242|NCT02152371|P2|Participant Flow|Placebo + Insulin Glargine|Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
658243|NCT02152371|P1|Participant Flow|Dulaglutide + Insulin Glargine|1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.
658244|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658245|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658246|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658247|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658248|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658249|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658250|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658251|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658252|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658253|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658254|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658255|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658399|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658256|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658257|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658258|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658259|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658260|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658261|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658262|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658263|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658264|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658265|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658266|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658267|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658268|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658269|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658270|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658271|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658272|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658273|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658274|NCT02152371|O2|Outcome|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658275|NCT02152371|O1|Outcome|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658276|NCT02152371|E2|Reported Event|Placebo + Insulin Glargine|"Placebo administered SQ once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Placebo: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658277|NCT02152371|E1|Reported Event|Dulaglutide + Insulin Glargine|"1.5 milligrams (mg) dulaglutide administered subcutaneously (SQ) once weekly for 28 weeks. Titrated insulin glargine administered SQ once daily for 28 weeks. Participants who are taking metformin should remain on stable doses.~Dulaglutide: Administered SQ~Insulin Glargine: Administered SQ~Metformin: Administered orally"
658278|NCT02152007|B1|Baseline|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
658279|NCT02152007|P1|Participant Flow|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
658280|NCT02152007|O2|Outcome|Placebo Cream (Vehicle Control)|Placebo Cream (Vehicle Control)
658281|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
658282|NCT02152007|O1|Outcome|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
658283|NCT02152007|E1|Reported Event|Split-body 1% Sirolimus Cream (TD201 1%)|"This is a split-body design. Subjects will self-administer 1% topical sirolimus cream or placebo cream (no drug, vehicle control) on the plantar surface of each foot. At least one foot will be treated with topical sirolimus at some time during the study. Application will be one time daily for a total of 26 weeks. There will be an additional follow-up visit 3 months after the last application of study drug. The total duration of the study is 39 weeks.~1% sirolimus cream (TD201 1%): 1% sirolimus cream (TD201 1%)"
658284|NCT02151994|B4|Baseline|Total|Total of all reporting groups
658285|NCT02151994|B3|Baseline|Food Interaction (Food Effect, FE) Analysis|This part consisted of an eligibility screening period, an open-label two-way crossover study period, and a follow-up period. One group of 12 subjects received single doses of 400 mg BIA 5-1058 during 2 treatment periods, once after having fasted overnight and once after consumption of a high fat breakfast. Each treatment was separated by a period of at least 7 days. The treatment sequence was determined by randomisation.
658286|NCT02151994|B2|Baseline|Multiple Ascending Dose (MAD)|This part consisted of an eligibility screening period, one study period involving administration of multiple doses of BIA 5-1058 or placebo once daily for 10 days, and a follow-up period. Five sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
658320|NCT02151994|E17|Reported Event|400 mg (MAD Period)|MAD period
658321|NCT02151994|E16|Reported Event|200 mg (MAD Period)|MAD period
658322|NCT02151994|E15|Reported Event|100 mg (MAD Period)|MAD period
658287|NCT02151994|B1|Baseline|Single Ascending Dose (SAD)|This part consisted of an eligibility screening period, one study period involving administration of single doses of BIA 5-1058 or placebo according to a randomised design, and a follow-up period. Nine sequential groups of 8 healthy young male subjects were dosed. Within each group, 6 subjects were randomised to receive BIA 5-1058 and 2 subjects were randomised to receive placebo.
658288|NCT02151994|P13|Participant Flow|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
658289|NCT02151994|P12|Participant Flow|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets FE part: A single dose of 400 mg BIA 5-1058 on Day 1 under fasted (one period) and fed (one period) conditions.
658290|NCT02151994|P11|Participant Flow|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
658291|NCT02151994|P10|Participant Flow|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
658292|NCT02151994|P9|Participant Flow|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg.
658293|NCT02151994|P8|Participant Flow|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
658350|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
658294|NCT02151994|P7|Participant Flow|400 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
658295|NCT02151994|P6|Participant Flow|200 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
658296|NCT02151994|P5|Participant Flow|100 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
658297|NCT02151994|P4|Participant Flow|50 mg|"BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.~MAD part: Multiple doses of BIA 5-1058 (n=6) or matching placebo (n=2) once daily on Days 1 to 10, at the following dose levels: 50, 100, 200, 400 and 1200 mg."
658298|NCT02151994|P3|Participant Flow|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
658299|NCT02151994|P2|Participant Flow|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets SAD part: Single dose of BIA 5-1058 (n=6) or matching placebo (n=2) on Day 1, at the following dose levels: 5, 25, 50, 100, 200, 400, 800, 1600 and 2400 mg. Escalation to the next higher dose and any dose adjustments of the next dose levels were based on safety and tolerability results of the previously administered dose and available PK data of previous dose groups.
658300|NCT02151994|P1|Participant Flow|Placebo|Placebo : visually matching active medication
658301|NCT02151994|O2|Outcome|400 mg Fed|BIA 5-1058 (5, 25 and 100 mg) tablets
658302|NCT02151994|O1|Outcome|400 mg Fasted|BIA 5-1058 (5, 25 and 100 mg) tablets
658303|NCT02151994|O6|Outcome|1200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658304|NCT02151994|O5|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658305|NCT02151994|O4|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658306|NCT02151994|O3|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658307|NCT02151994|O2|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658308|NCT02151994|O1|Outcome|Placebo|Placebo : visually matching active medication
658309|NCT02151994|O10|Outcome|2400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658310|NCT02151994|O9|Outcome|1600 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658311|NCT02151994|O8|Outcome|800 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658312|NCT02151994|O7|Outcome|400 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658313|NCT02151994|O6|Outcome|200 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658314|NCT02151994|O5|Outcome|100 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658315|NCT02151994|O4|Outcome|50 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658316|NCT02151994|O3|Outcome|25 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658317|NCT02151994|O2|Outcome|5 mg|BIA 5-1058 (5, 25 and 100 mg) tablets
658337|NCT02151786|B1|Baseline|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658338|NCT02151786|P1|Participant Flow|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658339|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658340|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658341|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658342|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658343|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658344|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658345|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658346|NCT02151786|O1|Outcome|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658347|NCT02151786|E1|Reported Event|Lansoprazole|Lansoprazole 30 milligram (mg), injection or drip infusion, intravenous, twice daily for up to 9 weeks.
658348|NCT02151773|B1|Baseline|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
658349|NCT02151773|P1|Participant Flow|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 milliliter (mL), injection, subcutaneously as a single dose as per routine medical practice were observed.
659444|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
658351|NCT02151773|O1|Outcome|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
658352|NCT02151773|E1|Reported Event|Live Attenuated Measles/Rubella Combined Vaccine|Participants receiving freeze-dried live attenuated measles/rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain) 0.5 mL, injection, subcutaneously as a single dose as per routine medical practice were observed.
658353|NCT02151253|B1|Baseline|All Randomized Participants|
658354|NCT02151253|P2|Participant Flow|Placebo First, Then Armodafinil|"During double-blind treatment subjects took placebo for 4 weeks before crossing over to armodafinil for 4 weeks. Pill is taken once daily, before 8 am.~Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
658355|NCT02151253|P1|Participant Flow|Armodafinil First, Then Placebo|"During double-blind treatment subjects took armodafinil for 4 weeks before crossing over to placebo for 4 weeks. Pill is taken once daily, before 8 am.~Armodafinil/placebo was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects."
658356|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658357|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658358|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658359|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658383|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658638|NCT02147288|P4|Participant Flow|Breast Recon With ADM on Jackson-Pratt (JP) Drains|
679771|NCT01979133|O1|Outcome|Baseline|Baseline QIDS Score
658360|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658361|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658362|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658363|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658397|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658398|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658364|NCT02151253|O2|Outcome|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658365|NCT02151253|O1|Outcome|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator’s and patient’s perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator’s and patient’s perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658366|NCT02151253|E2|Reported Event|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658367|NCT02151253|E1|Reported Event|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
658368|NCT02151058|B4|Baseline|Total|Total of all reporting groups
658369|NCT02151058|B3|Baseline|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658370|NCT02151058|B2|Baseline|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658371|NCT02151058|B1|Baseline|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658372|NCT02151058|P3|Participant Flow|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658373|NCT02151058|P2|Participant Flow|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658374|NCT02151058|P1|Participant Flow|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658375|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658376|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658377|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658378|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658379|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658380|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658381|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658382|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
679772|NCT01979133|O2|Outcome|Week 8|Week 8 HAMA Score
658384|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658385|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658386|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658387|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658388|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658389|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658390|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658391|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658392|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658393|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658394|NCT02151058|O2|Outcome|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658395|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658396|NCT02151058|O3|Outcome|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658401|NCT02151058|O1|Outcome|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658402|NCT02151058|E3|Reported Event|Investigative Mouth Rinse|Colgate® Regular Cavity Protection Toothpaste followed by Investigative Hydrogen Peroxide/Sodium Fluoride Mouth Rinse (Brushing followed by Mouth Rinse)
658403|NCT02151058|E2|Reported Event|Crest 3D|Colgate® Regular Cavity Protection Toothpaste followed by Crest® 3D Whitening Rinse (Brushing followed by Mouth Rinse)
658404|NCT02151058|E1|Reported Event|Negative Control|Colgate® Regular Cavity Protection Toothpaste (Brushing Only)
658405|NCT02150954|B3|Baseline|Total|Total of all reporting groups
658406|NCT02150954|B2|Baseline|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658407|NCT02150954|B1|Baseline|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658408|NCT02150954|P2|Participant Flow|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658409|NCT02150954|P1|Participant Flow|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658410|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658411|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658412|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658413|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658414|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658415|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658416|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658417|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658418|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658419|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658420|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658421|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658422|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658423|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658424|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658425|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658426|NCT02150954|O2|Outcome|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658427|NCT02150954|O1|Outcome|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658428|NCT02150954|E2|Reported Event|Foley Bulb With Standard Incremental Pitocin Infusion Protocol|"Subjects in this arm will receive a fixed low dose pitocin infusion protocol of 2 mius/min.~pitocin"
658429|NCT02150954|E1|Reported Event|Foley Bulb Induction With Low Dose Pitocin|"Subjects in this arm will receive a standard infusion protocol of pitocin starting at 1 milliunit/minute (mius/min) and increasing 2 milliunits per minute every 30 minutes.~pitocin"
658430|NCT02150499|B3|Baseline|Total|Total of all reporting groups
658431|NCT02150499|B2|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658432|NCT02150499|B1|Baseline|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658512|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
658513|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
658433|NCT02150499|P2|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658434|NCT02150499|P1|Participant Flow|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658435|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658436|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658437|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658438|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658439|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658440|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658441|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658442|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658443|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658481|NCT02150213|P1|Participant Flow|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
658444|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658445|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658446|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658447|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658448|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658449|NCT02150499|O2|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658450|NCT02150499|O1|Outcome|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658451|NCT02150499|E2|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Levalbuterol|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff) for 24 total puffs, cumulative dose of 1080 mcg levalbuterol tartrate HFA inhalation aerosol.~levalbuterol tartrate HFA inhalation aerosol"
658452|NCT02150499|E1|Reported Event|Levalbuterol Tartrate HFA Inhalation Aerosol Plus Placebo HFA|"Three doses. Each dose comprised of 8 puffs (4 puffs of levalbuterol tartrate HFA inhalation aerosol 45 mcg/puff plus 4 puffs of placebo HFA) for 24 total puffs, cumulative dose of 540 mcg levalbuterol tartrate HFA inhalation aerosol~levalbuterol tartrate HFA inhalation aerosol~placebo"
658453|NCT02150460|B3|Baseline|Total|Total of all reporting groups
658454|NCT02150460|B2|Baseline|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
658455|NCT02150460|B1|Baseline|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
658456|NCT02150460|P2|Participant Flow|Two-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15IU/ml into the infero-temporal and supero-nasal orbital compartments~Two- site peribulbar injection: Two injections into the infero-temporal and supero-nasal orbital compartments"
658457|NCT02150460|P1|Participant Flow|One-site Peribulbar Injection|"Injection of a mixture of lidocaine 2% + adrenaline 0.125mg/ml + hyaluronidase 15 International Units (IU)/ml into the inferior medial orbital compartment~One-site peribulbar injection: injection into the inferior medial orbital compartment"
658458|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658459|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658460|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658461|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658462|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658463|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658464|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658465|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658466|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658467|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658468|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658469|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658470|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658471|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658472|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658473|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658474|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658475|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658476|NCT02150460|O2|Outcome|Group 2|Two-site peribulbar injection
658477|NCT02150460|O1|Outcome|Group 1|One-site peribulbar injection
658478|NCT02150460|E2|Reported Event|Group 2|Two-site peribulbar injection
658479|NCT02150460|E1|Reported Event|Group 1|One-site peribulbar injection
658480|NCT02150213|B1|Baseline|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
658498|NCT02150044|P1|Participant Flow|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
658482|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
658483|NCT02150213|O1|Outcome|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
658484|NCT02150213|E1|Reported Event|BGG492|This was a follow-up safety study where study treatment was not administered. Patients came from BGG492 studies where patients were previously exposed to > 28 days of BGG492 50 mg, 100 mg or 150 mg given orally three times a day
658485|NCT02150109|B1|Baseline|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH (329) and WITHOUT (43) diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
658486|NCT02150109|P1|Participant Flow|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
658514|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
658515|NCT02149875|O1|Outcome|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
658516|NCT02149875|E3|Reported Event|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
658517|NCT02149875|E2|Reported Event|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
669391|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
658487|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
658488|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
658489|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
658490|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
658491|NCT02150109|O1|Outcome|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
658492|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes (329) used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
658493|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject fingerstick blood (329 WITH Diabetes) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
658494|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH Diabetes Use Karajishi Contour BGMS: Study staff tested subject venous blood from subjects WITH Diabetes (329) and BG results were compared to reference method results obtained from subject venous plasma."
658495|NCT02150109|O1|Outcome|Persons With Diabetes|"Untrained subjects WITH Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH (329) Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH diabetes used the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma."
658496|NCT02150109|E1|Reported Event|Persons With and Without Diabetes|"Untrained subjects WITH/WITHOUT Diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System).~Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS: Untrained subjects WITH and WITHOUT diabetes used Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
658497|NCT02150044|B1|Baseline|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
658499|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
658500|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
658501|NCT02150044|O1|Outcome|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
658502|NCT02150044|E1|Reported Event|Tympanostomy Tube|"Performance and safety of tympanostomy tube delivery system~Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system"
658503|NCT02149875|B4|Baseline|Total|Total of all reporting groups
658504|NCT02149875|B3|Baseline|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
658505|NCT02149875|B2|Baseline|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
658506|NCT02149875|B1|Baseline|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
658507|NCT02149875|P3|Participant Flow|Placebo|"Intravenous infusion of 100 ml saline intravenous q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
658508|NCT02149875|P2|Participant Flow|Cerebrolysin|"Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
658509|NCT02149875|P1|Participant Flow|Dl-3-n-butylphthalide|"Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days~Dl-3-n-butylphthalide, Cerebrolysin and Placebo separately"
658510|NCT02149875|O3|Outcome|Placebo|Intravenous infusion of 100 ml saline intravenous q.d. for 10 days.
658511|NCT02149875|O2|Outcome|Cerebrolysin|Intravenous infusion of 30 ml cerebrolysin q.d. for 10 days.
669392|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
658518|NCT02149875|E1|Reported Event|Dl-3-n-butylphthalide|Intravenous infusion of 25mg dl-3-n-butylphthalide b.i.d.for 10 days.
658519|NCT02149342|B1|Baseline|Hexylaminolaevulinate and Methylaminoalevulinate Cream|0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) and 16% methylaminolaevulinate (Metvix, Galderma) in a split-face design
658520|NCT02149342|P1|Participant Flow|Hexylaminolaevulinate and Methylaminoalevulinate Creams|"0,2% hexylaminolaevulinate cream , HAL (Hexvix, Photocure, Unguentum M, Almirall) 16% methylaminolaevulinate, MAL (Metvix, Galderma)~HAL and MAL used as photosensitizer for daylight-PDT in a randomized split-face design"
658521|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
658522|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
658523|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
658524|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
658525|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
658526|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
658527|NCT02149342|O2|Outcome|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
658528|NCT02149342|O1|Outcome|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream"
658529|NCT02149342|E2|Reported Event|Methylaminolaevulinate Cream|"16% methylaminolaevulinate (Metvix, Galderma)~Methylaminolaevulinate cream: MAL 16% is used as photosensitizer for daylight-PDT"
658530|NCT02149342|E1|Reported Event|Hexylaminolaevulinate Cream|"0.2% hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) (2014) 2% hexylaminolaevulinate (Hexvix Photocure) mixed with Unguentum M (Allmiral) (2015)~Hexylaminolaevulinate cream: 0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)"
658531|NCT02149303|B1|Baseline|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
658532|NCT02149303|P1|Participant Flow|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
658558|NCT02148107|B1|Baseline|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658559|NCT02148107|P3|Participant Flow|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
658533|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
658534|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
658535|NCT02149303|O1|Outcome|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
658536|NCT02149303|E1|Reported Event|Dabigatran Etexilate (Pradaxa®)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at five U.S. sites who received dabigatran (at the 75 mg and 150 mg dosages, orally twice daily), who had an acute bleeding event (index event), and either presented to an Emergency Department/ Emergency Room (ED / ER) or were hospitalized primarily for management of a major bleeding event.
658537|NCT02148809|B1|Baseline|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
658538|NCT02148809|P1|Participant Flow|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
658539|NCT02148809|O1|Outcome|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
658895|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658540|NCT02148809|O1|Outcome|Pilot Study|"14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study (Table 1).~Exclusion criteria were blood coagulopathies, medication with anti-coagulants, coronary artery disease, congestive heart failure, kidney insufficiency (creatinine > 1.5 mg/dl), aortic or mitral valve disease, pulmonary hypertension, and known hypersensitivity to the tracer.~All of them underwent total hip arthroplasty by one high-volume surgeon using a posterior or anterior approach."
658541|NCT02148809|E1|Reported Event|Pilot Study|14 patients (7men, 7 women) between 52 and 74 years were enrolled in the study
658542|NCT02148523|B4|Baseline|Total|Total of all reporting groups
658543|NCT02148523|B3|Baseline|Arm 3|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658544|NCT02148523|B2|Baseline|Arm 2|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658545|NCT02148523|B1|Baseline|Arm 1|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658546|NCT02148523|P3|Participant Flow|Arm 3|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658547|NCT02148523|P2|Participant Flow|Arm 2|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658548|NCT02148523|P1|Participant Flow|Arm 1|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658549|NCT02148523|O3|Outcome|Arm 3|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658550|NCT02148523|O2|Outcome|Arm 2|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658551|NCT02148523|O1|Outcome|Arm 1|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658552|NCT02148523|E3|Reported Event|Arm 3|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658553|NCT02148523|E2|Reported Event|Arm 2|"Adherence report to subject every 7 days with tailored comparison messages based on subject's adherence.~Comparison to peers~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658554|NCT02148523|E1|Reported Event|Arm 1|"Adherence report to subject every 7 days.~Adherence feedback~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
658555|NCT02148107|B4|Baseline|Total|Total of all reporting groups
658556|NCT02148107|B3|Baseline|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
658557|NCT02148107|B2|Baseline|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658634|NCT02147288|P8|Participant Flow|Abdominoplasty on JP Drains|
658560|NCT02148107|P2|Participant Flow|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658561|NCT02148107|P1|Participant Flow|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658562|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658563|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658564|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658565|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658566|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658567|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658568|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658569|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658570|NCT02148107|O3|Outcome|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
658571|NCT02148107|O2|Outcome|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658572|NCT02148107|O1|Outcome|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658573|NCT02148107|E3|Reported Event|BI 691751 3mg|Oral administration of BI 681751 3mg, consisting of two 0.5 mg tablets and a 2mg tablet, taken once daily for 14 days.
658574|NCT02148107|E2|Reported Event|BI 691751 0.5mg|Oral administration of a BI 691751 0.5mg tablet taken once daily for 14 days
658575|NCT02148107|E1|Reported Event|Placebo|Oral administration of a placebo tablet matching the BI 691751 tablets, taken once daily for 14 days.
658576|NCT02147691|B3|Baseline|Total|Total of all reporting groups
658577|NCT02147691|B2|Baseline|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
658578|NCT02147691|B1|Baseline|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658579|NCT02147691|P2|Participant Flow|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidine 0.33%"
658580|NCT02147691|P1|Participant Flow|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 0.33 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658581|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658582|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658583|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658584|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658585|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658586|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658587|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658588|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658589|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658590|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658591|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658592|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658593|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658594|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658595|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658596|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658597|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658635|NCT02147288|P7|Participant Flow|Abdominoplasty on NPWT|
658598|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658599|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658600|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658601|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658602|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658603|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658604|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658605|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658606|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658607|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658608|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658609|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
669476|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
658610|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658611|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658612|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658613|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658614|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658615|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658616|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658617|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658618|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658619|NCT02147691|O2|Outcome|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658620|NCT02147691|O1|Outcome|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658621|NCT02147691|E2|Reported Event|Brimonidine 0.33% Gel|"Brimonidine 0.33% Gel applied to the face each morning~Brimonidone 0.33%"
658622|NCT02147691|E1|Reported Event|Finacea 15% Gel (Azelaic Acid 15%), Brimonidine 15 % Gel|"Finacea 15% Gel (azelaic acid 15%) followed 30 minutes later with application of Brimonidine 0.33% Gel each morning to the face~Finacea 15 % Gel (azelaic acid 15%) each evening to the face~Azelaic acid 15%~Brimonidine 0.33%"
658623|NCT02147561|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
658624|NCT02147561|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
658625|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
658626|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
658627|NCT02147561|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
658628|NCT02147561|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
658629|NCT02147288|B3|Baseline|Total|Total of all reporting groups
658630|NCT02147288|B2|Baseline|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
658631|NCT02147288|B1|Baseline|Panniculectomy on JP Drains|Standard of Care
658632|NCT02147288|P10|Participant Flow|Ventral Hernia Repair (VHR) on JP Drains|
658633|NCT02147288|P9|Participant Flow|Ventral Hernia Repair (VHR) on NPWT|
658639|NCT02147288|P3|Participant Flow|Breast Recon With Acellular Dermal Matrix (ADM) on NPWT|
658640|NCT02147288|P2|Participant Flow|Panniculectomy on Negative Pressure Wound Therapy (NPWT)|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
658641|NCT02147288|P1|Participant Flow|Panniculectomy on Jackson Pratt (JP) Drains|Standard of Care
658642|NCT02147288|O2|Outcome|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
658643|NCT02147288|O1|Outcome|Panniculectomy on JP Drains|Standard of Care
658644|NCT02147288|E2|Reported Event|Panniculectomy on NPWT|"The Smith&Nephew Renasys*GO device connected to non-compressible drains will be applied to the panniculectomy patients enrolled in this arm.~Renasys*GO Negative Pressure Wound Therapy System: Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains)."
658645|NCT02147288|E1|Reported Event|Panniculectomy on JP Drains|Standard of Care
658646|NCT02147093|B3|Baseline|Total|Total of all reporting groups
658647|NCT02147093|B2|Baseline|Test (Filcon II 3-multi-focal) / Control (Filcon II 3-spher)|All subjects that were randomized to sequence and were dispensed a study lens.
658648|NCT02147093|B1|Baseline|Control (Filcon II 3-sphere) /Test (Filcon II 3-multi-focal)|All subjects that were randomized to sequence and were dispensed a study lens.
658649|NCT02147093|P2|Participant Flow|Test (Filcon II 3-multi-focal) /Control (Filcon II 3- Sphere)|Subjects were first fitted with the Test lens (filcon II 3-multi-focal) for one week. Subjects were then fitted with Control lens (filcon II 3- sphere) and a pair of reading glasses for one week.
658650|NCT02147093|P1|Participant Flow|Control (Filcon II 3- Sphere) /Test (Filcon II 3-multi-focal)|Subjects were first fitted with the Control lens (filcon II 3- sphere) and a pair of reading glasses for one week. Subjects were then fitted with the Test lens (filcon II 3-multi-focal) for one week.
658651|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
658652|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
658653|NCT02147093|O2|Outcome|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
658654|NCT02147093|O1|Outcome|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
658655|NCT02147093|E2|Reported Event|Test (Filcon II 3-multi-focal)|Subjects that were dispensed the Test lens (filcon II 3-multi-focal) in either the first or second period of the study.
658656|NCT02147093|E1|Reported Event|Control (Filcon II 3-sphere)|Subjects that were dispensed the Control lens (filcon II 3-sphere) in either the first or second period of the study.
658657|NCT02146599|B1|Baseline|Pseudophakic|Administration of patient self assessment
658658|NCT02146599|P1|Participant Flow|Pseudophakic|Administration of patient self assessment
658659|NCT02146599|O1|Outcome|Pseudophakic|Administration of patient self assessment
658660|NCT02146599|E1|Reported Event|Pseudophakic|Administration of patient self assessment
658661|NCT02146482|B3|Baseline|Total|Total of all reporting groups
658662|NCT02146482|B2|Baseline|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
658663|NCT02146482|B1|Baseline|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
658664|NCT02146482|P2|Participant Flow|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
658665|NCT02146482|P1|Participant Flow|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
658666|NCT02146482|O2|Outcome|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
658667|NCT02146482|O1|Outcome|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
658668|NCT02146482|E2|Reported Event|Sit-stand Computer Workstation|"Given a sit-stand computer workstation to use at their place of work~Sit-stand computer workstation: A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer."
658669|NCT02146482|E1|Reported Event|Control|Did not receive an intervention during the active portion of the study (i.e. 12 weeks). After the active portion of the study, this group was given a sit-stand computer workstation.
658670|NCT02146352|B1|Baseline|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658671|NCT02146352|P1|Participant Flow|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658745|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658672|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658673|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658674|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658675|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658676|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658677|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658678|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658805|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658679|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658680|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658681|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658682|NCT02146352|O1|Outcome|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658683|NCT02146352|E1|Reported Event|Treatment|"AXIOS Stent with Electrocautery Enhanced Delivery System~AXIOS Stent with Electrocautery Enhanced Delivery System: Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days."
658684|NCT02146326|B5|Baseline|Total|Total of all reporting groups
658685|NCT02146326|B4|Baseline|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658686|NCT02146326|B3|Baseline|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658687|NCT02146326|B2|Baseline|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658688|NCT02146326|B1|Baseline|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658689|NCT02146326|P4|Participant Flow|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
658690|NCT02146326|P3|Participant Flow|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months."
658691|NCT02146326|P2|Participant Flow|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the Motivational Interviewing (MI) intervention:~Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
658692|NCT02146326|P1|Participant Flow|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE) intervention:~Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
658693|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658694|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658746|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658695|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658696|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658697|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658698|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658699|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658700|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658701|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658702|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
669477|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
658703|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658704|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658705|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658706|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658707|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658708|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658709|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658710|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658711|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658712|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658713|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658714|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658715|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658716|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658717|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658718|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658719|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658720|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658721|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658722|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658723|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658724|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658725|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658726|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658727|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658728|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658729|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658730|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658731|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658732|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658733|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658734|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658735|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658736|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658737|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658738|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658739|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658740|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658741|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658742|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658743|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658744|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658747|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658748|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658749|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658750|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658751|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658752|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658753|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658754|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658755|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658756|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658757|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658758|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658759|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658760|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658761|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658762|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658763|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658764|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658765|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658766|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658767|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658768|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658769|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658770|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658771|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658772|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658773|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658774|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658775|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658776|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658777|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients: were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658778|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658779|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658780|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658781|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658782|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658783|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658784|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658785|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658786|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658787|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658788|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658789|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658790|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658791|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658792|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658793|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658794|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658795|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658796|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658797|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658798|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658799|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658800|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658801|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658802|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658803|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658804|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658806|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658807|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658808|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658809|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658810|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658811|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658812|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658813|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|"Clients linked to staff randomized to the MI intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
658814|NCT02146326|O3|Outcome|BREATHE-Clients|"Clients linked to staff randomized to the BREATHE intervention:~Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months"
658815|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|"Mental Health Care Staff randomized to the MI intervention:~Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
658816|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|"Mental Health Care Staff randomized to the BREATHE intervention:~Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months."
658817|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658818|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658819|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658820|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658821|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
659278|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
658822|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658823|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658824|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658825|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658826|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658827|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658828|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658829|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658830|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658831|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658832|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658833|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658834|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658835|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658836|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658837|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658838|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658839|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658840|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658841|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658842|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658843|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658844|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658845|NCT02146326|O4|Outcome|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658846|NCT02146326|O3|Outcome|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention: Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
659138|NCT02143583|B3|Baseline|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
658847|NCT02146326|O2|Outcome|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention: Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658848|NCT02146326|O1|Outcome|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention: Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658849|NCT02146326|E4|Reported Event|Motivational Interviewing-Clients|Clients linked to staff randomized to the MI intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658850|NCT02146326|E3|Reported Event|BREATHE-Clients|Clients linked to staff randomized to the BREATHE intervention Clients were invited to be interviewed at the following time points: Baseline, 6 months, and 12 months.
658851|NCT02146326|E2|Reported Event|Motivational Interviewing-Mental Health Care Staff|Mental Health Care Staff randomized to the MI intervention Staff were invited to attend an 8-9 hour MI workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658852|NCT02146326|E1|Reported Event|BREATHE-Mental Health Care Staff|Mental Health Care Staff randomized to the BREATHE intervention Staff were invited to attend an 8-9 hour BREATHE workshop delivered in 3 sessions, each about one month apart. Staff were asked to complete online surveys at the following time points: Baseline, 3 months, 6 months, and 12 months.
658853|NCT02146248|B1|Baseline|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
659445|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
658854|NCT02146248|P1|Participant Flow|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
658855|NCT02146248|O1|Outcome|HSG 5|post DMPA OC HSG
658856|NCT02146248|O1|Outcome|HSG 4|DMPA HSG
658857|NCT02146248|O1|Outcome|HSG 3|OC HSG
658858|NCT02146248|O1|Outcome|Tubal Patency Change|Change in tubal patency after OC treatment
658859|NCT02146248|O1|Outcome|Follicular Phase HSG|
658860|NCT02146248|E1|Reported Event|HSG Studies|"Women will be given combined oral contraceptives and Depo-medroxyprogesterone acetate (DepoProvera®).~2 HSG studies will be done prior to hormonal treatment, 1 after the pill treatment, and depending on whether the tubes appear patent, 1 more after the depoProvera treatment, and a final HSG after another 2 weeks on the pill.~Combined oral contraceptive: combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption~DepoProvera: injectable hormonal contraceptive"
658861|NCT02146105|B1|Baseline|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
658862|NCT02146105|P1|Participant Flow|Yoga Intervention|Participants completed a yoga strengthening program designed for knee osteoarthritis (OA). This program was taught by a certified yoga instructor who was trained to deliver the strengthening program. Participants were asked to attend 3 classes per week for 12 weeks. Each class was 1 hour in duration.
658863|NCT02146105|O1|Outcome|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
658864|NCT02146105|E1|Reported Event|Yoga For Knee Osteoarthritis|"An tailored arthritis-specific yoga program for women with knee osteoarthritis with the aim of increasing leg strength and alleviating knee pain related to the disease.~Yoga For Knee Osteoarthritis: Yoga program specifically for women with knee osteoarthritis."
658865|NCT02146001|B3|Baseline|Total|Total of all reporting groups
658866|NCT02146001|B2|Baseline|Sit Less|Targeting 1 hour less of sedentary time per day
658867|NCT02146001|B1|Baseline|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
658868|NCT02146001|P2|Participant Flow|Sit Less|Targeting 1 hour less of sedentary time per day
658869|NCT02146001|P1|Participant Flow|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
658870|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
658871|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
658872|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
658873|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
658874|NCT02146001|O2|Outcome|Sit Less|Targeting 1 hour less of sedentary time per day
658875|NCT02146001|O1|Outcome|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
658876|NCT02146001|E2|Reported Event|Sit Less|Targeting 1 hour less of sedentary time per day
658877|NCT02146001|E1|Reported Event|Get Active|Targeting 150 minutes/week of moderate-to-vigorous intensity physical activity
658878|NCT02145754|B1|Baseline|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
658879|NCT02145754|P1|Participant Flow|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-h media~MKP media versus BSK-H media"
659279|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
658880|NCT02145754|O1|Outcome|MKP Media Versus BSK-H Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
658881|NCT02145754|E1|Reported Event|MKP Media Versus BSK-h Media|"cultivation of Borrelia burgdorferi sensu lato (from skin specimens obtained from erythema migrans patients) in MKP media and in BSK-H media~MKP media versus BSK-H media"
658882|NCT02145676|B4|Baseline|Total|Total of all reporting groups
658883|NCT02145676|B3|Baseline|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658884|NCT02145676|B2|Baseline|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658885|NCT02145676|B1|Baseline|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658886|NCT02145676|P3|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658887|NCT02145676|P2|Participant Flow|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658888|NCT02145676|P1|Participant Flow|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658889|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658890|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658891|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658892|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658893|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658894|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658896|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658897|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658898|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658899|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658900|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658901|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658902|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658903|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658904|NCT02145676|O3|Outcome|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658905|NCT02145676|O2|Outcome|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658906|NCT02145676|O1|Outcome|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658907|NCT02145676|E3|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
658908|NCT02145676|E2|Reported Event|onabotulinumtoxinA 300U|OnabotulinumtoxinA 300U injected into predefined muscles of the study limb on Day 1.
658909|NCT02145676|E1|Reported Event|onabotulinumtoxinA 500U|OnabotulinumtoxinA 500U injected into predefined muscles of the study limb on Day 1.
658910|NCT02145468|B3|Baseline|Total|Total of all reporting groups
658911|NCT02145468|B2|Baseline|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658912|NCT02145468|B1|Baseline|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658913|NCT02145468|P2|Participant Flow|Losmapimod 7.5 Mllligrms BID|Participants received losmapimod 7.5 milligrams (mg) tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658914|NCT02145468|P1|Participant Flow|Placebo|Participants received losmapimod matching placebo tablets via oral route, twice daily (BID), according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658915|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658916|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658917|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658918|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658919|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658920|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658921|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658922|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658923|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658924|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658925|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658926|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658927|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658928|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658929|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658930|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658931|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658932|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658933|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658934|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658935|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658936|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658937|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658938|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658939|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658940|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658941|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658942|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658943|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658944|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658945|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658946|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658947|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658948|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658949|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658950|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658951|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658952|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658953|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658954|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658955|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658956|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658957|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658958|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658959|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658960|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658961|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658962|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658963|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658964|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658965|NCT02145468|O2|Outcome|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658966|NCT02145468|O1|Outcome|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658967|NCT02145468|E2|Reported Event|Losmapimod 7.5 mg BID|Participants received losmapimod 7.5 mg tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658968|NCT02145468|E1|Reported Event|Placebo|Participants received losmapimod matching placebo tablets via oral route, BID, according to the randomization schedule for 12 weeks in addition to standard of care, and were followed for an additional 12 weeks after completing treatment, for a total study duration of 24 weeks.
658969|NCT02145299|B3|Baseline|Total|Total of all reporting groups
658970|NCT02145299|B2|Baseline|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658992|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
659059|NCT02144259|B2|Baseline|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
659446|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
658971|NCT02145299|B1|Baseline|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658972|NCT02145299|P2|Participant Flow|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658973|NCT02145299|P1|Participant Flow|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658974|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658975|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658976|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658977|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658978|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
659046|NCT02144337|B1|Baseline|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
658979|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658980|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
659006|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
658981|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658982|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658983|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658984|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658985|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658986|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658987|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658988|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658989|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658990|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658991|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658993|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658994|NCT02145299|O2|Outcome|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658995|NCT02145299|O1|Outcome|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658996|NCT02145299|E2|Reported Event|CROSSER CTO Device|"The CrosserTM CTO Recanalization Catheter (“Crosser system”) (Bard Peripheral Vascular Inc. Tempe, AZ, USA), which serves as a control in this investigation, gained U.S. FDA approval for peripheral indications in 2011. The device is similar in both design and indications to the TruePath device, with the exception that the Crosser system uses vibrational angioplasty to achieve CTO crossing.~CROSSER CTO Device"
658997|NCT02145299|E1|Reported Event|TruePath CTO Device|"The TruePath™ CTO Device (Boston Scientific Corporation, Natick, MA) is a new solution for intraluminal treatment of chronic total occlusions (CTO). It is the longest available crossing device (165 cm), and has a diamond-coated distal tip that can rotate at 13,000 rpm. Its profile is similar to a 0.018” guidewire, and includes a shapeable distal tip allowing 1:1 torque response. In addition, it provides audio and visual navigation during CTO crossing.~TruePath CTO Device: The TruePath CTO Device is composed of a 0.018” guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
658998|NCT02145156|B4|Baseline|Total|Total of all reporting groups
658999|NCT02145156|B3|Baseline|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659000|NCT02145156|B2|Baseline|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659001|NCT02145156|B1|Baseline|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659002|NCT02145156|P3|Participant Flow|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659047|NCT02144337|P2|Participant Flow|Control Group|Control group. Children in the Control group are asked to continue normal daily activities.
659003|NCT02145156|P2|Participant Flow|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659004|NCT02145156|P1|Participant Flow|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659005|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659152|NCT02143583|E1|Reported Event|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
659007|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659008|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659009|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659010|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659011|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659012|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659013|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659014|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659015|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659030|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659016|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659017|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659018|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659056|NCT02144337|E1|Reported Event|Steps To Active Kids (STAK) Programme|"6 week Steps To Active Kids (STAK) physical activity programme (combined supervised and home-based physical activity).~Steps To Active Kids (STAK) Programme: 6 week programme of combined supervised and home-based (non-supervised) physical activity."
659057|NCT02144259|B4|Baseline|Total|Total of all reporting groups
659058|NCT02144259|B3|Baseline|Control Group|Subjects selecting their own method of contraception or no contraception.
659019|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659020|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659021|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659022|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659023|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659024|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659025|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659026|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659027|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659028|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659029|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
679773|NCT01979133|O1|Outcome|Baseline|Baseline HAMA Score
659031|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659032|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659033|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659034|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659035|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659036|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659037|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659038|NCT02145156|O3|Outcome|Usual Care|"Intervention: Survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659039|NCT02145156|O2|Outcome|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659040|NCT02145156|O1|Outcome|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659041|NCT02145156|E3|Reported Event|Usual Care|"Intervention: Survey-only. Intervention: survey-only. Participants in the usual care arm will not view any educational materials or complete the baseline survey.~Survey-only: Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed."
659042|NCT02145156|E2|Reported Event|Untailored Intervention|"Intervention: Untailored educational materials. In this arm, patients will view educational information on the iPad that is not responsive to their baseline questionnaire answers.~Untailored educational materials: The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV “Vaccine Information Sheet” that has been created by the Centers for Disease Control and Prevention."
659043|NCT02145156|E1|Reported Event|Tailored Intervention|"Intervention: Tailored educational materials. In this arm, participants will complete a baseline survey on an iPad, view a series of educational webpages on the iPad, and complete a brief post intervention survey.~Tailored educational materials: The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented."
659044|NCT02144337|B3|Baseline|Total|Total of all reporting groups
659045|NCT02144337|B2|Baseline|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
659139|NCT02143583|B2|Baseline|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
659048|NCT02144337|P1|Participant Flow|Intervention Group|6 week Steps To Active Kids (STAK) programme includes: StreetDance DVD designed to be completed at home (4 weeks in total). A dance routine is taught over 4 weeks with new elements introduced each day. Activity diary aims to encourage children to record daily activities in a logbook and to educate children about physical activity. Step counter: Children are given a pedometer and encouraged to record steps in the activity diary and to set personal goals to increase their steps. Weekly group activity sessions for 4 – 6 weeks. Involve a circuit of activity stations varying in intensity. The group sessions are designed to be fun and non-competitive. Children can record their scores at each station and monitor their own progress.
659049|NCT02144337|O1|Outcome|Overall Study Group Sample|Intervention and control group combined
659050|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
659051|NCT02144337|O2|Outcome|Control Group|No intervention
659052|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
659053|NCT02144337|O2|Outcome|Control Group|No intervention
659054|NCT02144337|O1|Outcome|Intervention Group|Steps To Active Kids (STAK) programme
659055|NCT02144337|E2|Reported Event|Normal Daily Activity|Treatment as usual: children asked to continue normal daily activity as usual.
659153|NCT02142712|B4|Baseline|Total|Total of all reporting groups
659060|NCT02144259|B1|Baseline|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
659061|NCT02144259|P3|Participant Flow|Control Group|Subjects selecting their own method of contraception or no contraception.
659062|NCT02144259|P2|Participant Flow|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
659063|NCT02144259|P1|Participant Flow|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
659064|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
659065|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
659066|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
659067|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
659068|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
659069|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
659070|NCT02144259|O3|Outcome|Control Group|Subjects selecting their own method of contraception or no contraception.
659071|NCT02144259|O2|Outcome|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
659072|NCT02144259|O1|Outcome|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
659073|NCT02144259|E3|Reported Event|Control Group|Subjects selecting their own method of contraception or no contraception.
659074|NCT02144259|E2|Reported Event|Implanon Group|"Subjects randomized to receive Implanon immediately post-partum.~Implanon immediately postpartum: Implanon ® is a subdermal implant that contains 68mg of etonogestrel."
659075|NCT02144259|E1|Reported Event|DMPA Group|"Subjects randomized to receive DepoProvera(DMPA) immediately post-partum.~DMPA immediately postpartum: DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate."
659076|NCT02144220|B1|Baseline|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659077|NCT02144220|P1|Participant Flow|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659078|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659079|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659080|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659081|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659082|NCT02144220|O1|Outcome|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659083|NCT02144220|E1|Reported Event|Virtual Care Visit|"One-time virtual care visit for Parkinson disease.~Virtual care visit: Video-conferencing visit with a Parkinson disease specialist"
659084|NCT02144012|B3|Baseline|Total|Total of all reporting groups
659136|NCT02143947|E1|Reported Event|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
659085|NCT02144012|B2|Baseline|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659086|NCT02144012|B1|Baseline|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659087|NCT02144012|P2|Participant Flow|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659088|NCT02144012|P1|Participant Flow|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659154|NCT02142712|B3|Baseline|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659447|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659089|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659090|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659091|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659092|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659093|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659094|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659095|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659096|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659097|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659098|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659135|NCT02143947|E2|Reported Event|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
659137|NCT02143583|B4|Baseline|Total|Total of all reporting groups
659099|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659100|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659101|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659102|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659103|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659104|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659105|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659106|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659107|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659108|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659109|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659110|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659111|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659112|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659113|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659114|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659115|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659116|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659117|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659118|NCT02144012|O2|Outcome|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659119|NCT02144012|O1|Outcome|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659120|NCT02144012|E2|Reported Event|Arm B: Trastuzumab + Docetaxel|"Participants were administered trastuzumab plus docetaxel Q3W. Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab: For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.~Docetaxel: Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W."
659121|NCT02144012|E1|Reported Event|Arm A: Trastuzumab Emtansine|"Participants were administered trastuzumab emtansine once every three weeks (Q3W). Participants could remain on study treatment until investigator assessed disease progression, unacceptable toxicity, or Sponsor study termination occurs, whichever occurs first.~Trastuzumab Emtansine: Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W."
659122|NCT02143947|B3|Baseline|Total|Total of all reporting groups
659123|NCT02143947|B2|Baseline|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
659124|NCT02143947|B1|Baseline|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
659125|NCT02143947|P2|Participant Flow|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
659126|NCT02143947|P1|Participant Flow|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
659127|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
659128|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
659129|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
659130|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
659131|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: The in-shoe orthosis is a custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
659132|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The full contact in-shoe orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
659133|NCT02143947|O2|Outcome|Maximal Arch Subtalar Stabilization|"Maximal Arch Subtalar Stabilization Orthoses~Maximal Arch Subtalar Stabilization: Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover"
659134|NCT02143947|O1|Outcome|Full Contact Orthosis|"Full Contact Orthosis~Full Contact Orthosis: The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
659140|NCT02143583|B1|Baseline|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
659141|NCT02143583|P3|Participant Flow|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
659142|NCT02143583|P2|Participant Flow|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
659143|NCT02143583|P1|Participant Flow|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
659144|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
659145|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
659146|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
659147|NCT02143583|O3|Outcome|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
659148|NCT02143583|O2|Outcome|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
659149|NCT02143583|O1|Outcome|AllerT 100 μg|patients having received AllerT at a first dose of 50 μg and 4 maintenance doses of 100 μg in study AN004T
659150|NCT02143583|E3|Reported Event|Placebo|Patients having received Placebo (i.e., adjuvant alone) delivered in the same manner as AllerT in study AN004T
659151|NCT02143583|E2|Reported Event|AllerT 50 μg|patients having received AllerT at a first dose of 25 μg and 4 maintenance doses of 50 μg in study AN004T
659155|NCT02142712|B2|Baseline|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
659156|NCT02142712|B1|Baseline|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659157|NCT02142712|P4|Participant Flow|Dextromethorphan|Dextromethorphan- 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) + current standard of care
659158|NCT02142712|P3|Participant Flow|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659159|NCT02142712|P2|Participant Flow|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
659160|NCT02142712|P1|Participant Flow|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659161|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659162|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
659163|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659164|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659165|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
659166|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659167|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659168|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659169|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659170|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659171|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659172|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659173|NCT02142712|O3|Outcome|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659174|NCT02142712|O2|Outcome|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
659175|NCT02142712|O1|Outcome|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659176|NCT02142712|E3|Reported Event|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
659177|NCT02142712|E2|Reported Event|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care
659178|NCT02142712|E1|Reported Event|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
659179|NCT02142504|B4|Baseline|Total|Total of all reporting groups
659271|NCT02142361|P3|Participant Flow|Methafilcon B/Enfilcon A|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659180|NCT02142504|B3|Baseline|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659181|NCT02142504|B2|Baseline|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659182|NCT02142504|B1|Baseline|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659183|NCT02142504|P3|Participant Flow|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659184|NCT02142504|P2|Participant Flow|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659185|NCT02142504|P1|Participant Flow|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659186|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659187|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659188|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659189|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659190|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659191|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659192|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659193|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659194|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659195|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659196|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659197|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659272|NCT02142361|P2|Participant Flow|Ocufilcon D/Enfilcon A|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659198|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659199|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659200|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659201|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659202|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659203|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659204|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659205|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659206|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659207|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659208|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659209|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659210|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659211|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659212|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659213|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659214|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659215|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659273|NCT02142361|P1|Participant Flow|Omafilcon A/Enfilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659216|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659217|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659218|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659219|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659220|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659221|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659222|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659223|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659224|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659225|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659226|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659227|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659228|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659229|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659230|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659231|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659232|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659233|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659274|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659275|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659234|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659235|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659236|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659237|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659238|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659239|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659240|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659241|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659242|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659243|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659244|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659245|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659246|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659247|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659248|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659249|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659250|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659251|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659276|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659277|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659252|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659253|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659254|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659255|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659256|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659257|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659258|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659259|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659260|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659261|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659262|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659263|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659264|NCT02142504|O3|Outcome|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659265|NCT02142504|O2|Outcome|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659266|NCT02142504|O1|Outcome|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659267|NCT02142504|E3|Reported Event|GI.1/GII.4 50/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no MPL), on Day 365.
659268|NCT02142504|E2|Reported Event|GI.1/GII.4 15/50 μg - MPL 50 μg + GI.1/GII.4 15/15 μg (no MPL)|IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MPL and 500 µg aluminum hydroxide, on Day 1, followed by IM norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, (no MPL) on Day 365.
659269|NCT02142504|E1|Reported Event|Saline Placebo + GI.1/GII.4 15/15 μg (No MPL)|Intramuscular (IM) saline placebo on Day 1, followed by IM norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide (no monophosphoryl lipid A [MPL]), on Day 365.
659270|NCT02142361|B1|Baseline|Overall Study Group|All participants were habitual wearers of hydrogel toric lenses (omafilcon A, ocufilcon D or methafilcon B), and refitted with silicone hydrogel toric lens (enfilcon A)
659280|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659281|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659282|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659283|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659284|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659285|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659286|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659287|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659288|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659289|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659290|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659291|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659292|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659293|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659294|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659295|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659296|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659297|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659298|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659299|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659300|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659301|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659302|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659303|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659304|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659305|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659306|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659307|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659308|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659309|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659310|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659311|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659312|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659313|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659314|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659315|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659316|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659317|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at baseline.
659318|NCT02142361|O2|Outcome|Study Lens|Subjects dispensed with study lens pair (Enfilcon A) pair and surveyed 1 week.
659319|NCT02142361|O1|Outcome|Habitual Lenses|Subjects habitual hydrogel toric lens pairs surveyed at 1 week.
659320|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659321|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659322|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659323|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659324|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659325|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659326|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659327|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659328|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659425|NCT02141997|B2|Baseline|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659329|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659330|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659331|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659332|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659333|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659334|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659335|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659336|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659337|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659338|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659448|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659339|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659340|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659341|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659342|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659343|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659344|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659345|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659346|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659347|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659348|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659349|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659350|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659351|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659352|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659353|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659354|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659355|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659356|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659357|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659358|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659359|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659360|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659361|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659362|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659363|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659364|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659365|NCT02142361|O3|Outcome|Methafilcon B|Subject's habitual hydrogel toric lenses (methafilcon B) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659366|NCT02142361|O2|Outcome|Ocufilcon D|Subject's habitual hydrogel toric lenses (ocufilcon D) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659367|NCT02142361|O1|Outcome|Omafilcon A|Subject's habitual hydrogel toric lenses (omafilcon A) will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses (enfilcon A).
659368|NCT02142361|E3|Reported Event|Methafilcon B|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
659399|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
659449|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659369|NCT02142361|E2|Reported Event|Ocufilcon D|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
659370|NCT02142361|E1|Reported Event|Omafilcon A|"Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation.~enfilcon A: Subject's habitual hydrogel toric lenses will be evaluated at the first visit and then re-fitted with a pair of silicon hydrogel toric lenses. After 1 week of daily wear, subjects will return for a second and final evaluation."
659371|NCT02142153|B11|Baseline|Total|Total of all reporting groups
659372|NCT02142153|B10|Baseline|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659373|NCT02142153|B9|Baseline|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659374|NCT02142153|B8|Baseline|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659375|NCT02142153|B7|Baseline|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659376|NCT02142153|B6|Baseline|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659377|NCT02142153|B5|Baseline|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659378|NCT02142153|B4|Baseline|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659379|NCT02142153|B3|Baseline|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659380|NCT02142153|B2|Baseline|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659381|NCT02142153|B1|Baseline|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659382|NCT02142153|P10|Participant Flow|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659383|NCT02142153|P9|Participant Flow|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659384|NCT02142153|P8|Participant Flow|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659385|NCT02142153|P7|Participant Flow|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659386|NCT02142153|P6|Participant Flow|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659387|NCT02142153|P5|Participant Flow|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659388|NCT02142153|P4|Participant Flow|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659389|NCT02142153|P3|Participant Flow|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659390|NCT02142153|P2|Participant Flow|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659426|NCT02141997|B1|Baseline|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659391|NCT02142153|P1|Participant Flow|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659392|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
659393|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
659394|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
659395|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
659396|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
659397|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
659398|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically sign significant safety lab and ECG abnormalities No clinically significant findings"
670055|NCT02057406|B2|Baseline|High EPA|"Almost pure EPA 2 grams~High EPA"
659400|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of clinically significant safety lab and ECG abnormalities No clinically significant findings"
659401|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of clinically significant safety laboratory abnormalities and ECG abnormalities.~No clinically significant findings"
659402|NCT02142153|O10|Outcome|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659403|NCT02142153|O9|Outcome|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659404|NCT02142153|O8|Outcome|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659405|NCT02142153|O7|Outcome|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659406|NCT02142153|O6|Outcome|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659407|NCT02142153|O5|Outcome|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659408|NCT02142153|O4|Outcome|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659409|NCT02142153|O3|Outcome|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659410|NCT02142153|O2|Outcome|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659411|NCT02142153|O1|Outcome|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659412|NCT02142153|E10|Reported Event|Placebo 4 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659413|NCT02142153|E9|Reported Event|F901318 4 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659414|NCT02142153|E8|Reported Event|Placebo 3 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659415|NCT02142153|E7|Reported Event|F901318 3 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659416|NCT02142153|E6|Reported Event|Placebo 1.5 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659417|NCT02142153|E5|Reported Event|F901318 1.5 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659418|NCT02142153|E4|Reported Event|Placebo 0.75 mg/kg|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659419|NCT02142153|E3|Reported Event|F901318 0.75 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659420|NCT02142153|E2|Reported Event|0.25 mg/kg Placebo|"Single intravenous infusion over 4 hours~Placebo: Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities"
659421|NCT02142153|E1|Reported Event|F901318 0.25 mg/kg|"Single intravenous infusion over 4 hours~F901318: Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.~Pharmacokinetic profile"
659422|NCT02141997|B5|Baseline|Total|Total of all reporting groups
659423|NCT02141997|B4|Baseline|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659424|NCT02141997|B3|Baseline|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
679774|NCT01979133|O2|Outcome|Week 8|Week 8 HAMD Score
659427|NCT02141997|P4|Participant Flow|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659428|NCT02141997|P3|Participant Flow|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659429|NCT02141997|P2|Participant Flow|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659430|NCT02141997|P1|Participant Flow|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659431|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659432|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659433|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659434|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659435|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659436|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659437|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659438|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659439|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659440|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659441|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659442|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659443|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659450|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659451|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659452|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659453|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659454|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659455|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659456|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659457|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659458|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659459|NCT02141997|O4|Outcome|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659460|NCT02141997|O3|Outcome|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659461|NCT02141997|O2|Outcome|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659462|NCT02141997|O1|Outcome|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659463|NCT02141997|E4|Reported Event|ABT-122 120 mg EW|ABT-122 120 mg every week (EW) for 11 weeks.
659464|NCT02141997|E3|Reported Event|ABT-122 120 mg EOW|ABT-122 120 mg every other week (EOW) for 11 weeks.
659465|NCT02141997|E2|Reported Event|ABT-122 60 mg EOW|ABT-122 60 mg every other week (EOW) for 11 weeks.
659466|NCT02141997|E1|Reported Event|Adalimumab 40 mg EOW|Adalimumab 40 mg every other week (EOW) for 11 weeks.
659467|NCT02141867|B1|Baseline|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery. Age 43.5 (SD 17.6) years, Male 1994 (50.8%)
659468|NCT02141867|P1|Participant Flow|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
659469|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
659470|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
659471|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
659472|NCT02141867|O1|Outcome|Noncardiac Surgical Patients|Noncardiac surgery patients 16 years or older undergoing inpatient surgery
659473|NCT02141867|E1|Reported Event|Non Cardiac Surgery|Non cardiac surgery patients 16 years or older
659474|NCT02141854|B6|Baseline|Total|Total of all reporting groups
659475|NCT02141854|B5|Baseline|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659476|NCT02141854|B4|Baseline|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659477|NCT02141854|B3|Baseline|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659604|NCT02141620|E2|Reported Event|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
659478|NCT02141854|B2|Baseline|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659479|NCT02141854|B1|Baseline|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659480|NCT02141854|P6|Participant Flow|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659481|NCT02141854|P5|Participant Flow|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659482|NCT02141854|P4|Participant Flow|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659561|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659562|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659563|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
672812|NCT02032212|B5|Baseline|Total|Total of all reporting groups
659483|NCT02141854|P3|Participant Flow|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659484|NCT02141854|P2|Participant Flow|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659485|NCT02141854|P1|Participant Flow|Fluticasone Propionate 50 mcg BID|All enrolled participants used single-blind fluticasone propionate multidose dry powder inhaler twice a day for a total daily dose of 100 mcg during the Run-In Period (14-21 days).
659486|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659487|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659488|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659489|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659490|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659491|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659492|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659493|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659650|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659494|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659495|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659496|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659497|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659498|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659499|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659500|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659501|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659502|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659503|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659504|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659505|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659506|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659507|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659508|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659542|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
660686|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
659509|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659510|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659511|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659512|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659513|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659514|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659515|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659516|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659517|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659518|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659519|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659520|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659521|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659522|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659523|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659543|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
660687|NCT02135432|E2|Reported Event|Placebo|"matching placebo~Placebo"
659524|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659525|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659526|NCT02141854|O5|Outcome|Placebo MDPI|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659527|NCT02141854|O4|Outcome|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659528|NCT02141854|O3|Outcome|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659529|NCT02141854|O2|Outcome|FS MDPI 100 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659530|NCT02141854|O1|Outcome|FS MDPI 200 / 12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659531|NCT02141854|E5|Reported Event|Placebo|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of placebo for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659532|NCT02141854|E4|Reported Event|Fp MDPI 200 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 400 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659533|NCT02141854|E3|Reported Event|Fp MDPI 100 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate (Fp) for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659534|NCT02141854|E2|Reported Event|FS MDPI 200/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation twice a day using a multidose dry powder inhaler (MDPI) of fluticasone propionate 200 mcg (for a total daily dose of 400 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659535|NCT02141854|E1|Reported Event|FS MDPI 100/12.5 mcg|"Following randomization, participants in this treatment arm took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salmeterol HFA MDI: Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659536|NCT02141633|B3|Baseline|Total|Total of all reporting groups
659537|NCT02141633|B2|Baseline|Non-smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
659538|NCT02141633|B1|Baseline|Smokers|"echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
659539|NCT02141633|P2|Participant Flow|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
659540|NCT02141633|P1|Participant Flow|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
659541|NCT02141633|O2|Outcome|Non-smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
659544|NCT02141633|O1|Outcome|Smokers|"participants will performed airway blood flow and echocardiogram before and 15 minutes after inhalation of albuterol.~echocardiogram: participants will performed echocardiogram before and 15 minutes after inhaled albuterol~airway blood flow: participants will performed echocardiogram before and 15 minutes after inhaled albuterol"
659545|NCT02141633|E2|Reported Event|Non-smokers|No AE or SAE had occurred
659546|NCT02141633|E1|Reported Event|Smokers|No AE or SAE had occurred
659547|NCT02141620|B1|Baseline|All Study Participants|All subjects who completed the study.
659548|NCT02141620|P2|Participant Flow|n-Acetylcysteine Then Placebo|Subjects were maintained on 2.4 g n-acetylcysteine for 7 days, then they were crossed over to placebo daily for 7 days.
659549|NCT02141620|P1|Participant Flow|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
659550|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659551|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659552|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659553|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659554|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659555|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659556|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659557|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659558|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659559|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659560|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659564|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659565|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659566|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659567|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659568|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659569|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659570|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659571|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659572|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659573|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659574|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659575|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659576|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659577|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659578|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659579|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659580|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659581|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659582|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659583|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659584|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659585|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659586|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659587|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659588|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659589|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659590|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659591|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659592|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659593|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659594|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659595|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659596|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659597|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659598|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659599|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659600|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659601|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659602|NCT02141620|O2|Outcome|n-Acetylcysteine|Subjects were maintained on 2.4 g n-Acetylcysteine for 7 days.
659603|NCT02141620|O1|Outcome|Placebo|Subjects were maintained on Placebo for 7 days.
659605|NCT02141620|E1|Reported Event|Placebo Then n-Acetylcysteine|Subjects were maintained on placebo for 7 days, then they were crossed over to 2.4 g n-acetylcysteine daily for 7 days.
659606|NCT02141581|B4|Baseline|Total|Total of all reporting groups
659607|NCT02141581|B3|Baseline|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
659608|NCT02141581|B2|Baseline|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
659609|NCT02141581|B1|Baseline|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
659610|NCT02141581|P3|Participant Flow|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
659611|NCT02141581|P2|Participant Flow|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
659612|NCT02141581|P1|Participant Flow|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
659613|NCT02141581|O3|Outcome|Group C Flumist®|Participants in this group will be randomized to Flumist® administered intranasally.
659614|NCT02141581|O2|Outcome|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
659615|NCT02141581|O1|Outcome|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
659616|NCT02141581|O3|Outcome|Group C Flumist®|Participants in this group will be randomized to Flumist® administered intranasally.
659617|NCT02141581|O2|Outcome|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
659618|NCT02141581|O1|Outcome|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
659619|NCT02141581|E3|Reported Event|Group C FluMist®|Participants in this group will be randomized to FluMist® administered intranasally.
659620|NCT02141581|E2|Reported Event|Group B Fluzone® (ID)|Participants in this group will be randomized to Fluzone® administered intradermally (ID)
659621|NCT02141581|E1|Reported Event|Group A Fluzone® (IM)|Participants in this group will be randomized to Fluzone® administered intramuscularly (IM)
659622|NCT02141516|B4|Baseline|Total|Total of all reporting groups
659623|NCT02141516|B3|Baseline|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659624|NCT02141516|B2|Baseline|Asplenia|Subjects aged ≥ 2 to ≤17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659625|NCT02141516|B1|Baseline|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659626|NCT02141516|P3|Participant Flow|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659627|NCT02141516|P2|Participant Flow|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659628|NCT02141516|P1|Participant Flow|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659629|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659630|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659631|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659632|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659633|NCT02141516|O5|Outcome|Total|Total of subjects
659634|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659635|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659636|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659637|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659638|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659639|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659640|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659641|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659642|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659643|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659644|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659645|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659646|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659647|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659648|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659649|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
679775|NCT01979133|O1|Outcome|Baseline|Baseline HAMD Score
659651|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659652|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659653|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659654|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659655|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659656|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659657|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659658|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659659|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659660|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659661|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659662|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659663|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659664|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659665|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659666|NCT02141516|O4|Outcome|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659667|NCT02141516|O3|Outcome|CompDef + Asplenia|Subjects aged ≥ 2 to ≤ 17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659668|NCT02141516|O2|Outcome|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659669|NCT02141516|O1|Outcome|CompDef|Subjects aged ≥ 2 to ≤ 17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659670|NCT02141516|E5|Reported Event|Total|Total number of Subjects
659671|NCT02141516|E4|Reported Event|Healthy|Healthy subjects aged ≥ 2 to ≤ 17 years received 2 doses of rMenB+OMV NZ administered 2 months apart.
659672|NCT02141516|E3|Reported Event|CompDef + Asplenia|Subjects aged ≥ 2 to ≤17 years with either complement deficiencies or Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659673|NCT02141516|E2|Reported Event|Asplenia|Subjects aged ≥ 2 to ≤ 17 years with Asplenia received 2 doses of rMenB+OMV NZ administered 2 months apart.
659674|NCT02141516|E1|Reported Event|CompDef|Subjects aged ≥ 2 to ≤17 years with complement deficiencies received 2 doses of rMenB+OMV NZ administered 2 months apart.
659675|NCT02141217|B3|Baseline|Total|Total of all reporting groups
659676|NCT02141217|B2|Baseline|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659677|NCT02141217|B1|Baseline|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659678|NCT02141217|P2|Participant Flow|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659679|NCT02141217|P1|Participant Flow|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659680|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659681|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659682|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659683|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659684|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659685|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659686|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659741|NCT02140645|B4|Baseline|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659687|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659688|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants randomized to clindamycin 150 mg.
659689|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants randomized to amoxicillin 875 mg plus clavulanic acid 125 mg.
659690|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659691|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659692|NCT02141217|O2|Outcome|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659693|NCT02141217|O1|Outcome|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 mg plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659694|NCT02141217|E2|Reported Event|Clindamycin 150 mg|Participants received clindamycin 150 mg orally four times daily for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659695|NCT02141217|E1|Reported Event|Amoxicillin 875 mg + Clavulanic Acid 125 mg|Participants received amoxicillin 875 milligrams (mg) plus clavulanic acid 125 mg orally twice daily with meals for a duration of five to seven days in participants with acute odontogenic infection with or without abscess.
659696|NCT02140957|B3|Baseline|Total|Total of all reporting groups
659721|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
659697|NCT02140957|B2|Baseline|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659698|NCT02140957|B1|Baseline|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659699|NCT02140957|P2|Participant Flow|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659700|NCT02140957|P1|Participant Flow|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659701|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659713|NCT02140788|P1|Participant Flow|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
659714|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
659980|NCT02139878|E1|Reported Event|Wild Blueberry Juice|240 ml Wild Blueberry Juice daily in either first intervention period or second intervention period
659702|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659703|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659722|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
659723|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
660170|NCT02138461|B1|Baseline|Bimatoprost|These patients take bimatoprost topically for glaucoma.
659704|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659705|NCT02140957|O2|Outcome|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659706|NCT02140957|O1|Outcome|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659707|NCT02140957|E2|Reported Event|Control|"Parents in this arm received a placebo which consisted of standard nutritional counseling alone.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659708|NCT02140957|E1|Reported Event|Educational Intervention|"Parents in this arm received a 5 minute educational intervention on bottle cessation plus standard nutritional counseling.~Educational Intervention: Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information."
659709|NCT02140788|B1|Baseline|All Subjects Who Consented|All subjects who signed a consent form
659710|NCT02140788|P4|Participant Flow|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
659711|NCT02140788|P3|Participant Flow|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
659712|NCT02140788|P2|Participant Flow|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
659715|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
659981|NCT02139644|B6|Baseline|Total|Total of all reporting groups
659716|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
659717|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
659718|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
659719|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
659720|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
659869|NCT02140060|B7|Baseline|Total|Total of all reporting groups
659948|NCT02139982|E8|Reported Event|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
659724|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
659725|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
659726|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
659727|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
659728|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
659729|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
659730|NCT02140788|O4|Outcome|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
659731|NCT02140788|O3|Outcome|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
659732|NCT02140788|O2|Outcome|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
659733|NCT02140788|O1|Outcome|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
659734|NCT02140788|E4|Reported Event|No Medication Added|Subjects will continue to take the clozapine prescribed as standard of care. Subjects will not receive Metformin or Fish Oil.
659735|NCT02140788|E3|Reported Event|Metformin and Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects will receive Metformin and Fish Oil as part of the study.~Metformin~Fish Oil"
659736|NCT02140788|E2|Reported Event|Fish Oil|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added fish oil will receive OmegaBrite 500 mg gel cap BID days 1-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate the dose escalation to 1000 mg BID will have the fish oil dose reduce to 500 mg BID.~Fish Oil"
659737|NCT02140788|E1|Reported Event|Metformin|"Subjects will continue to take the clozapine prescribed as standard of care. Subjects assigned to added metformin will receive metformin 250 mg BID days 1-3, 500 mg BID days 4-7, and 1000 mg BID days 8-28 with breakfast and supper. Patients unable to tolerate a dose escalation will have the metformin dose reduced to the previously tolerated lower dose.~Metformin"
659738|NCT02140645|B7|Baseline|Total|Total of all reporting groups
659739|NCT02140645|B6|Baseline|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659740|NCT02140645|B5|Baseline|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
663640|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
659742|NCT02140645|B3|Baseline|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659743|NCT02140645|B2|Baseline|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659744|NCT02140645|B1|Baseline|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659745|NCT02140645|P6|Participant Flow|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659746|NCT02140645|P5|Participant Flow|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659747|NCT02140645|P4|Participant Flow|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659748|NCT02140645|P3|Participant Flow|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659749|NCT02140645|P2|Participant Flow|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659750|NCT02140645|P1|Participant Flow|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659947|NCT02139982|E9|Reported Event|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
659751|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659752|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659753|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659754|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659755|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659756|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659757|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659758|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659759|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659760|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659761|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659762|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659763|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659764|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659765|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659766|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659767|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659768|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659769|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659770|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659771|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
660214|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
659772|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659773|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659774|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659775|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659776|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659777|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659778|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659779|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659780|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659781|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659782|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659783|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659784|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659785|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659786|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659787|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659788|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659789|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659790|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659791|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659792|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659793|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659794|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659795|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659796|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659797|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659798|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659799|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659800|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659801|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
660210|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
659802|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659803|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659804|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659805|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659806|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659807|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659808|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659809|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659810|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659811|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659812|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659813|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659814|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659815|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659816|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659817|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659818|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659819|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659820|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659821|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659822|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659823|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659824|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659825|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
659826|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659827|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659828|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659829|NCT02140645|O6|Outcome|Second Generation Sulfonylurea|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication second generation sulfonylurea.
659830|NCT02140645|O5|Outcome|Linagliptin 3|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to second generation sulfonylurea.
659831|NCT02140645|O4|Outcome|Pioglitazone|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication pioglitazone.
660211|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
659832|NCT02140645|O3|Outcome|Linagliptin 2|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to pioglitazone.
659833|NCT02140645|O2|Outcome|Any Other DPP-4|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659834|NCT02140645|O1|Outcome|Linagliptin 1|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication Linagliptin subjects matched to any other DPP-4 (Dipeptidyl peptidase-4 inhibitors).
659835|NCT02140645|E1|Reported Event|MarketScan|Patients had a recorded diagnosis of type 2 diabetes mellitus (T2DM) using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
659836|NCT02140593|B3|Baseline|Total|Total of all reporting groups
659837|NCT02140593|B2|Baseline|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
659838|NCT02140593|B1|Baseline|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
659839|NCT02140593|P2|Participant Flow|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
659840|NCT02140593|P1|Participant Flow|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
659841|NCT02140593|O2|Outcome|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
659842|NCT02140593|O1|Outcome|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
659843|NCT02140593|O2|Outcome|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
659844|NCT02140593|O1|Outcome|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
659845|NCT02140593|E2|Reported Event|Deep Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level post tetanic count (PTC) of 0-1 combined with bolus saline (placebo) mimicking standard treatment.~Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment."
659846|NCT02140593|E1|Reported Event|Standard Neuromuscular Blockade|"Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment decided by the attending anesthetist combined with saline infusion (placebo).~Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo)."
659847|NCT02140372|B1|Baseline|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659848|NCT02140372|P1|Participant Flow|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659849|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659850|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659851|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659852|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659853|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659854|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659855|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659856|NCT02140372|O1|Outcome|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659857|NCT02140372|E1|Reported Event|Volunteer Group|"Baseline blood draw followed by colchicine followed by blood draw 2 hours and 24 hours later~Colchicine: Colchicine 1.2 mg followed by 0.6 mg one hour later"
659858|NCT02140164|B1|Baseline|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659859|NCT02140164|P1|Participant Flow|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659860|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659861|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659862|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659863|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659864|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659865|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659866|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659867|NCT02140164|O1|Outcome|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659868|NCT02140164|E1|Reported Event|Minocycline|"Oral administration of minocycline~Minocycline: Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months."
659870|NCT02140060|B6|Baseline|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659871|NCT02140060|B5|Baseline|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
659872|NCT02140060|B4|Baseline|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659873|NCT02140060|B3|Baseline|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659874|NCT02140060|B2|Baseline|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659875|NCT02140060|B1|Baseline|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659876|NCT02140060|P6|Participant Flow|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659877|NCT02140060|P5|Participant Flow|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
659878|NCT02140060|P4|Participant Flow|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659879|NCT02140060|P3|Participant Flow|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659880|NCT02140060|P2|Participant Flow|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659881|NCT02140060|P1|Participant Flow|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659882|NCT02140060|O6|Outcome|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659883|NCT02140060|O5|Outcome|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
659884|NCT02140060|O4|Outcome|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659885|NCT02140060|O3|Outcome|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659886|NCT02140060|O2|Outcome|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659887|NCT02140060|O1|Outcome|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659888|NCT02140060|E7|Reported Event|Pre-treatment|All subjects who signed an informed consent to participate in the study
659889|NCT02140060|E6|Reported Event|TRAV Z + AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) twice daily morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659890|NCT02140060|E5|Reported Event|AZOPT|Ophthalmic suspension, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night for 6 weeks
659891|NCT02140060|E4|Reported Event|TRAV Z|Suspension vehicle, 1 drop twice daily in the treated eye(s) morning and night, with travoprost 0.004% ophthalmic solution, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659892|NCT02140060|E3|Reported Event|TravC/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659893|NCT02140060|E2|Reported Event|TravB/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659894|NCT02140060|E1|Reported Event|TravA/Brinz|Fixed combination, 1 drop twice daily in the treated eye(s) morning and night, with travoprost solution vehicle, 1 drop once daily in the treated eye(s) at night, for 6 weeks
659895|NCT02139982|B11|Baseline|Total|Total of all reporting groups
659896|NCT02139982|B10|Baseline|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
659897|NCT02139982|B9|Baseline|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
659898|NCT02139982|B8|Baseline|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
659899|NCT02139982|B7|Baseline|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
659900|NCT02139982|B6|Baseline|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
659901|NCT02139982|B5|Baseline|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
659902|NCT02139982|B4|Baseline|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659903|NCT02139982|B3|Baseline|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659904|NCT02139982|B2|Baseline|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659905|NCT02139982|B1|Baseline|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659906|NCT02139982|P10|Participant Flow|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
659907|NCT02139982|P9|Participant Flow|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
659908|NCT02139982|P8|Participant Flow|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
659909|NCT02139982|P7|Participant Flow|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
659910|NCT02139982|P6|Participant Flow|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
659911|NCT02139982|P5|Participant Flow|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
659912|NCT02139982|P4|Participant Flow|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659913|NCT02139982|P3|Participant Flow|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659914|NCT02139982|P2|Participant Flow|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659915|NCT02139982|P1|Participant Flow|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659916|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659917|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659918|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659919|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659920|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
659921|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
659922|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
659923|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
659924|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
659925|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
659926|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
659927|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
659928|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
659929|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
659930|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
659931|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
659932|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659933|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
660212|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
659934|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659935|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659936|NCT02139982|O6|Outcome|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
659937|NCT02139982|O5|Outcome|Group E(Phase 2)|"30ml ropivacaine 0.5%~ropivacaine: Different concentration of ropivacaine"
659938|NCT02139982|O4|Outcome|Group D(Phase 2)|"30ml ropivacaine 0.375%~ropivacaine: Different concentration of ropivacaine"
659939|NCT02139982|O3|Outcome|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
659940|NCT02139982|O2|Outcome|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
659941|NCT02139982|O1|Outcome|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
659942|NCT02139982|O4|Outcome|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659943|NCT02139982|O3|Outcome|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659944|NCT02139982|O2|Outcome|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659945|NCT02139982|O1|Outcome|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659946|NCT02139982|E10|Reported Event|Group F(Phase 2)|"30ml ropivacaine 0.75%~ropivacaine: Different concentration of ropivacaine"
659949|NCT02139982|E7|Reported Event|Group C(Phase 2)|"30ml ropivacaine 0.25%~ropivacaine: Different concentration of ropivacaine"
659950|NCT02139982|E6|Reported Event|Group B(Phase 2)|"30ml ropivacaine 0.2%~ropivacaine: Different concentration of ropivacaine"
659951|NCT02139982|E5|Reported Event|Group A(Phase 2)|"30ml ropivacaine 0.125%~ropivacaine: Different concentration of ropivacaine"
659952|NCT02139982|E4|Reported Event|Group ME (Phase 1)|"specific nerve block:median nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659953|NCT02139982|E3|Reported Event|Group RA (Phase 1)|"specific nerve block:radial nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659954|NCT02139982|E2|Reported Event|Group UL( Phase 1)|"specific nerve block:ulnar nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659955|NCT02139982|E1|Reported Event|Group MC(Phase 1)|"specific nerve block:musculocutaneous nerve block~specific nerve block: specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region"
659956|NCT02139943|B4|Baseline|Total|Total of all reporting groups
659957|NCT02139943|B3|Baseline|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
659958|NCT02139943|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
659959|NCT02139943|B1|Baseline|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
659960|NCT02139943|P3|Participant Flow|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
659961|NCT02139943|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
659962|NCT02139943|P1|Participant Flow|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
659963|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
659964|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
659965|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
659966|NCT02139943|O3|Outcome|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
659967|NCT02139943|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
659968|NCT02139943|O1|Outcome|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
659969|NCT02139943|E3|Reported Event|Canagliflozin 300 mg|Participants received 300 mg of canagliflozin capsules once daily for 18 weeks.
659970|NCT02139943|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received 100 mg of canagliflozin capsules once daily for 18 weeks.
659971|NCT02139943|E1|Reported Event|Placebo|Participants received canagliflozin matching placebo capsules once daily for 18 weeks.
659972|NCT02139878|B1|Baseline|Entire Study Population|Includes groups randomized to receive Wild Blueberry Juice first and Placebo first
659973|NCT02139878|P2|Participant Flow|Placebo First, Then Wild Blueberry Juice|240 ml Placebo beverage daily in first intervention period and 240 ml Wild Blueberry Juice daily in second intervention period (after washout period).
659974|NCT02139878|P1|Participant Flow|Wild Blueberry Juice First, Then Placebo|240 ml Wild Blueberry Juice daily first in intervention period and 240 ml Placebo beverage daily in second intervention period (after washout period)
659975|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
659976|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
659977|NCT02139878|O2|Outcome|Placebo|240 ml placebo beverage
659978|NCT02139878|O1|Outcome|Wild Blueberry Juice|240 ml wild blueberry juice
659979|NCT02139878|E2|Reported Event|Placebo|240 ml Placebo beverage daily in either the first intervention period or second intervention period
659982|NCT02139644|B5|Baseline|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659983|NCT02139644|B4|Baseline|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659984|NCT02139644|B3|Baseline|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659985|NCT02139644|B2|Baseline|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659986|NCT02139644|B1|Baseline|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659987|NCT02139644|P6|Participant Flow|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660704|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
659988|NCT02139644|P5|Participant Flow|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659989|NCT02139644|P4|Participant Flow|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659990|NCT02139644|P3|Participant Flow|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659991|NCT02139644|P2|Participant Flow|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659992|NCT02139644|P1|Participant Flow|Enrolled Patients|During the run-in period (from the screening visit to the randomization visit), all patients replaced their current rescue medication with study-specific rescue medication (albuterol/salbutamol HFA MDI) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the period. All patients discontinued their current ICS or ICS/LABA, and took 1 inhalation twice a day from a single-blinded placebo MDPI device and 1 puff twice a day from open-label QVAR 40 mcg HFA MDI (or equivalent).
659993|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659994|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659995|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659996|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659997|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
659998|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660056|NCT02139137|B1|Baseline|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
659999|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660000|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660001|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660002|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660003|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660004|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660171|NCT02138461|P2|Participant Flow|Latanoprost Group|These patients take latanoprost topically for glaucoma.
660005|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660006|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660007|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660008|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660009|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660010|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660011|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660012|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660013|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660014|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660015|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660016|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660202|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660017|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660018|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660019|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660020|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660021|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660039|NCT02139644|E4|Reported Event|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660022|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660023|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660024|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660025|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660026|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660027|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660028|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660029|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660030|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660031|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660032|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660033|NCT02139644|O5|Outcome|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660034|NCT02139644|O4|Outcome|Fp MDPI 50 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 100 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660203|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660035|NCT02139644|O3|Outcome|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660036|NCT02139644|O2|Outcome|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660037|NCT02139644|O1|Outcome|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660038|NCT02139644|E5|Reported Event|Placebo MDPI|"The placebo multidose dry powder inhaler was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart).~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660064|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
660040|NCT02139644|E3|Reported Event|Fp MDPI 100 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate for a total daily dose of 200 mcg for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660041|NCT02139644|E2|Reported Event|FS MDPI 50 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 50 mcg (for a total daily dose of 100 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660042|NCT02139644|E1|Reported Event|FS MDPI 100 / 12.5 mcg|"Patients took 1 inhalation using a multidose dry powder inhaler (MDPI) twice a day of fluticasone propionate 100 mcg (for a total daily dose of 200 mcg) and salmeterol 12.5 mcg (for a total daily dose of 25 mcg) for 12 weeks.~Albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication."
660043|NCT02139228|B3|Baseline|Total|Total of all reporting groups
660044|NCT02139228|B2|Baseline|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660045|NCT02139228|B1|Baseline|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660046|NCT02139228|P2|Participant Flow|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660047|NCT02139228|P1|Participant Flow|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660048|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660049|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660050|NCT02139228|O2|Outcome|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660051|NCT02139228|O1|Outcome|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660052|NCT02139228|E2|Reported Event|Hib TT|"Subjects treated with 3 doses of Tetanus Toxoid-conjugate Haemophilus influenzae type b vaccine (comparator vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660053|NCT02139228|E1|Reported Event|Hib CRM197|"Subjects treated with 3 doses of CRM 197 –conjugate Haemophilus influenzae type b vaccine (study vaccine): 2 doses given one month apart during study V37_07 (NCT01044316) and a booster dose of the same vaccine six months after, during study V37_07E1 (NCT01226953).~No vaccine was administered during this trial"
660054|NCT02139137|B3|Baseline|Total|Total of all reporting groups
660055|NCT02139137|B2|Baseline|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
663641|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
660057|NCT02139137|P2|Participant Flow|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
660058|NCT02139137|P1|Participant Flow|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
660059|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
660060|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
660061|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
660062|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
660063|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
660172|NCT02138461|P1|Participant Flow|Bimatoprost|These patients take bimatoprost topically for glaucoma.
660065|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
660066|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
660067|NCT02139137|O2|Outcome|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
660068|NCT02139137|O1|Outcome|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
660069|NCT02139137|E2|Reported Event|Low Interference Control Condition|"Computerized training program requiring participants to minimally practice controlling interference on a cognitive task~Computerized cognitive training - sham: Sham training condition"
660070|NCT02139137|E1|Reported Event|High Interference Control Condition|"Computerized training program requiring participants to repeatedly practice controlling interference on a cognitive task~Computerized Cognitive Training - active: Cognitive training using working memory span task"
660071|NCT02139046|B6|Baseline|Total|Total of all reporting groups
660072|NCT02139046|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660073|NCT02139046|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660074|NCT02139046|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660075|NCT02139046|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660076|NCT02139046|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660077|NCT02139046|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660078|NCT02139046|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660079|NCT02139046|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660204|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660205|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660080|NCT02139046|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660081|NCT02139046|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660082|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660083|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660084|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660173|NCT02138461|O2|Outcome|Latanoprost Group|These patients take latanoprost topically for glaucoma.
660085|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660086|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660087|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660088|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660089|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660090|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660091|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660092|NCT02139046|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660093|NCT02139046|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660094|NCT02139046|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660095|NCT02139046|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660096|NCT02139046|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660097|NCT02139046|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660098|NCT02139046|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660099|NCT02139046|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660100|NCT02139046|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every day (for participants with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min) or every other day (if eGFR ≥ 15 - ≤ 59 mL/min), or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660101|NCT02139046|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every day or every other day, or, alternatively, if colchicine is not tolerated and the subject’s eGFR is ≥ 50 mL/min, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
660102|NCT02139007|B3|Baseline|Total|Total of all reporting groups
660103|NCT02139007|B2|Baseline|Discontinuation Arm|Alendronate discontinuation arm
660104|NCT02139007|B1|Baseline|Continuation Arm|Alendronate continuation arm
660174|NCT02138461|O1|Outcome|Bimatoprost|These patients take bimatoprost topically for glaucoma.
660105|NCT02139007|P2|Participant Flow|Discontinuation Arm|"Alendronate discontinuation arm~Participants were randomized to stop taking their current alendronate prescription."
660106|NCT02139007|P1|Participant Flow|Continuation Arm|"Alendronate continuation arm~Participants were randomized to continue their current alendronate prescription at prescribed dose."
660107|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
660108|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm~Alendronate"
660109|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
660110|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm~Alendronate"
660111|NCT02139007|O2|Outcome|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
660112|NCT02139007|O1|Outcome|Continuation Arm|"Alendronate continuation arm~Alendronate"
660113|NCT02139007|O1|Outcome|All Study Sites-Initiation to the First Participant Recruited|study initiation to the first participant recruited
660114|NCT02139007|O1|Outcome|All Study Sites --IRB Approval|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
660115|NCT02139007|O1|Outcome|All Study Sites -- Contracting Procedures|The duration of time from execution of contracts, IRB approval, and to participant recruitment is potential contributor to overall suboptimal recruitment in clinical research. In this pilot study we measured the mean duration of administrative procedures for sites to the first patient enrolled. .
660116|NCT02139007|E2|Reported Event|Discontinuation Arm|"Alendronate discontinuation arm~Alendronate"
660117|NCT02139007|E1|Reported Event|Continuation Arm|"Alendronate continuation arm~Alendronate"
660118|NCT02138825|B3|Baseline|Total|Total of all reporting groups
660119|NCT02138825|B2|Baseline|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660120|NCT02138825|B1|Baseline|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660121|NCT02138825|P2|Participant Flow|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660122|NCT02138825|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660206|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660207|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660213|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660123|NCT02138825|O2|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660124|NCT02138825|O1|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660141|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660142|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660554|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
660125|NCT02138825|O2|Outcome|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660126|NCT02138825|O1|Outcome|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of pulmonary hypertension (PH) associated with idiopathic interstitial pneumonias (IIP) or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660127|NCT02138825|E2|Reported Event|Placebo|In the main study treatment phase participants received sham titration within range of 0.5 mg TID to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, which included a blinded titration phase to optimal dose of Riociguat of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660128|NCT02138825|E1|Reported Event|Riociguat (Adempas, BAY63-2521)|In the main study treatment phase participants received Riociguat titrated to optimal dose within range of 0.5 mg TID (3 times a day) to 2.5 mg TID for 10 weeks followed by maintenance period of 16 weeks. This phase was followed by a long-term extension phase, throughout which all participants continued the treatment with Riociguat. The long-term extension phase included a blinded sham titration phase of 10 weeks followed by an open-label extension phase. During the open-label extension phase participants were to be treated with Riociguat until commercial access in the indication of PH associated with IIP or until an agreed time point is defined with the individual country, local regulatory authority and the Sponsor’s global team.
660129|NCT02138747|B5|Baseline|Total|Total of all reporting groups
660130|NCT02138747|B4|Baseline|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
660131|NCT02138747|B3|Baseline|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660132|NCT02138747|B2|Baseline|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
660133|NCT02138747|B1|Baseline|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
660134|NCT02138747|P4|Participant Flow|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
660135|NCT02138747|P3|Participant Flow|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660136|NCT02138747|P2|Participant Flow|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
660208|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660209|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
663642|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
660137|NCT02138747|P1|Participant Flow|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
660138|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660139|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660140|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660555|NCT02137382|E2|Reported Event|Creon N|Creon N: experimental drug
660143|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660144|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660145|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660146|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660147|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660148|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660149|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660150|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660151|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660152|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660153|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660154|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660155|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660156|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660157|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660158|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660159|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660160|NCT02138747|O4|Outcome|BB: Tolterodine ER /Tolterodine ER|Participants received 4 mg of tolterodine ER and PTM mirabegron 25 mg OCAS modified-release tablets orally once a day during period 1 and period 2.
660161|NCT02138747|O3|Outcome|AA: Mirabegron/Mirabegron|In treatment sequence AA participants received 25 mg of mirabegron and PTM tolterodine ER 4 mg capsules during period 1 and 2 orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660162|NCT02138747|O2|Outcome|BA: Tolterodine ER /Mirabegron|In the treatment sequence BA participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron (OCAS) modified-release tablets orally once a day during period 1. In the period 2, participants received 25 mg of mirabegron and 4 mg of PTM tolterodine ER orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
660163|NCT02138747|O1|Outcome|AB: Mirabegron/Tolterodine ER|In the treatment sequence AB participants received 25 mg of mirabegron (Myrbetriq) oral controlled absorption system (OCAS) modified-release tablets and 4 mg of placebo-to-match (PTM) tolterodine ER (Detrol LA) orally once a day during period 1. In the period 2, participants received 4 mg of tolterodine ER and 25 mg of PTM mirabegron orally once a day. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron or mirabegron PTM was increased to 50 mg for the remainder of the treatment period.
660164|NCT02138747|O2|Outcome|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660165|NCT02138747|O1|Outcome|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660166|NCT02138747|E2|Reported Event|Tolterodine ER|Participants received 4 mg of tolterodine ER capsules orally once a day for 8 weeks in treatment periods 1 and/or 2.
660167|NCT02138747|E1|Reported Event|Mirabegron|Participants received 25 mg of mirabegron oral controlled absorption system (OCAS) modified-release tablets orally once a day for 8 weeks in treatment periods 1 and/or 2. Four weeks after the start of each 8-week treatment period, 25 mg of mirabegron was increased to 50 mg for the remainder of the treatment period.
660168|NCT02138461|B3|Baseline|Total|Total of all reporting groups
660169|NCT02138461|B2|Baseline|Latanoprost Group|These patients take latanoprost topically for glaucoma.
660175|NCT02138461|E2|Reported Event|Latanoprost Group|These patients take latanoprost topically for glaucoma.
660176|NCT02138461|E1|Reported Event|Bimatoprost|These patients take bimatoprost topically for glaucoma.
660177|NCT02138097|B19|Baseline|Total|Total of all reporting groups
660178|NCT02138097|B18|Baseline|MS: GLP-I RA|Patients in the MarketScan (MS) cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660179|NCT02138097|B17|Baseline|MS: Alpha-Glucosidase Inhibitors|Patients in the MarketScan (MS) cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660180|NCT02138097|B16|Baseline|MS: Meglitinides|Patients in the MarketScan (MS) cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660181|NCT02138097|B15|Baseline|MS: Glitazones|Patients in the MarketScan (MS) cohort using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660182|NCT02138097|B14|Baseline|MS: Sulfonylurea|Patients in the MarketScan (MS) cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660183|NCT02138097|B13|Baseline|MS: Metformin|Patients in the MarketScan (MS) cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
660184|NCT02138097|B12|Baseline|MS: Saxagliptin|Patients in the MarketScan (MS) cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660185|NCT02138097|B11|Baseline|MS: Sitagliptin|Patients in the MarketScan (MS) cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660186|NCT02138097|B10|Baseline|MS: Linagliptin|Patients in the MarketScan (MS) cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660187|NCT02138097|B9|Baseline|UHC: GLP-I RA|Patients in the United Healthcare cohort using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660188|NCT02138097|B8|Baseline|UHC: Alpha-Glucosidase Inhibitors|Patients in the United Healthcare cohort using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660189|NCT02138097|B7|Baseline|UHC: Sulfonylurea|Patients in the United Healthcare cohort using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660190|NCT02138097|B6|Baseline|UHC: Sitagliptin|Patients in the United Healthcare cohort using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660191|NCT02138097|B5|Baseline|UHC: Saxagliptin|Patients in the United Healthcare cohort using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660192|NCT02138097|B4|Baseline|UHC: Metformin|Patients in the United Healthcare cohort using Metformin as an oral and non-insulin injected glucose-lowering medication.
660193|NCT02138097|B3|Baseline|UHC: Meglitinides|Patients in the United Healthcare cohort using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660194|NCT02138097|B2|Baseline|UHC: Linagliptin|Patients in the United Healthcare cohort using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660195|NCT02138097|B1|Baseline|UHC: Glitazones|Patients in the United Healthcare cohort (UHC) using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660196|NCT02138097|P2|Participant Flow|MarketScan|Patients using an oral and non-insulin injected glucose-lowering medication identified from the MarketScan database.
660197|NCT02138097|P1|Participant Flow|United Healthcare|Patients using an oral and non-insulin injected glucose-lowering medication identified from the United Healthcare Research database
660198|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660199|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660200|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660201|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
664333|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
660215|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660216|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660217|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660218|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660219|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660220|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660221|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660222|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660223|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660224|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660225|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660226|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660227|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660228|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660229|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660230|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660231|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660232|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660233|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660234|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660235|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660236|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660237|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660238|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660239|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660240|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660241|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660242|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660243|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660244|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660245|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660246|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660247|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660248|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660249|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660250|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660251|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660252|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660253|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660254|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660255|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660256|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660257|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660258|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660259|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660260|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660261|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660262|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660263|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660264|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660265|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660266|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660267|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660268|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660269|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660270|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660271|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660272|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660273|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660274|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660275|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660556|NCT02137382|E1|Reported Event|Creon®|Creon®: active comparator
660276|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660277|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660278|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660279|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660280|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660281|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660282|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660283|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660284|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660285|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660286|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660287|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660288|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660289|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660290|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660291|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660292|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660293|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660294|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660295|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660296|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660297|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660298|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660299|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660300|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660301|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660302|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660303|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660304|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660305|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660306|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
664334|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
660307|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660308|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660309|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660310|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660311|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660312|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660313|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660314|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660315|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660316|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660317|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660318|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660319|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660320|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660321|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660322|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660323|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660324|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660325|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660326|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660327|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660328|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660329|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660330|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660331|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660332|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660333|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660334|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660335|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660336|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660337|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660338|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660339|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660340|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660341|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660342|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660343|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660344|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660345|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660346|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660347|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660348|NCT02138097|O10|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660349|NCT02138097|O9|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660350|NCT02138097|O8|Outcome|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660351|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660352|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660353|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660354|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660355|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660356|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660357|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660358|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660359|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660360|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660361|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660362|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660363|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660364|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660365|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660366|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660557|NCT02136498|B3|Baseline|Total|Total of all reporting groups
673727|NCT02024386|B4|Baseline|Total|Total of all reporting groups
660367|NCT02138097|O9|Outcome|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660368|NCT02138097|O8|Outcome|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660369|NCT02138097|O7|Outcome|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660370|NCT02138097|O6|Outcome|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660371|NCT02138097|O5|Outcome|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660372|NCT02138097|O4|Outcome|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660373|NCT02138097|O3|Outcome|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660374|NCT02138097|O2|Outcome|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660375|NCT02138097|O1|Outcome|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660376|NCT02138097|E10|Reported Event|GLP-I RA|Patients using glucagon-like peptide-1 (GLP-1) receptor agonists (RA) as an oral and non-insulin injected glucose-lowering medication.
660377|NCT02138097|E9|Reported Event|Alpha-Glucosidase Inhibitors|Patients using Alpha-Glucosidase Inhibitors (AGI) as an oral and non-insulin injected glucose-lowering medication.
660378|NCT02138097|E8|Reported Event|Other DPP-4I|Patients using other dipeptidyl peptidase-4 inhibitors (DPP-4I) as an oral and non-insulin injected glucose-lowering medication.
660379|NCT02138097|E7|Reported Event|Sulfonylurea|Patients using Sulfonylurea as an oral and non-insulin injected glucose-lowering medication.
660380|NCT02138097|E6|Reported Event|Sitagliptin|Patients using Sitagliptin as an oral and non-insulin injected glucose-lowering medication.
660381|NCT02138097|E5|Reported Event|Saxagliptin|Patients using Saxagliptin as an oral and non-insulin injected glucose-lowering medication.
660382|NCT02138097|E4|Reported Event|Metformin|Patients using Metformin as an oral and non-insulin injected glucose-lowering medication.
660383|NCT02138097|E3|Reported Event|Meglitinides|Patients using Meglitinides as an oral and non-insulin injected glucose-lowering medication.
660384|NCT02138097|E2|Reported Event|Linagliptin|Patients using Linagliptin as an oral and non-insulin injected glucose-lowering medication.
660385|NCT02138097|E1|Reported Event|Glitazones|Patients using Glitazones as an oral and non-insulin injected glucose-lowering medication.
660386|NCT02138006|B3|Baseline|Total|Total of all reporting groups
660387|NCT02138006|B2|Baseline|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
660388|NCT02138006|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
660389|NCT02138006|P2|Participant Flow|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
660390|NCT02138006|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
660391|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
660392|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
660393|NCT02138006|O2|Outcome|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
660394|NCT02138006|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
660395|NCT02138006|E2|Reported Event|Standard Insulin Treatment|"Standard insulin treatment~Standard insulin treatment"
660396|NCT02138006|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment~Intensive insulin treatment"
660397|NCT02137785|B3|Baseline|Total|Total of all reporting groups
660398|NCT02137785|B2|Baseline|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660399|NCT02137785|B1|Baseline|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660509|NCT02137603|P2|Participant Flow|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
660400|NCT02137785|P2|Participant Flow|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660401|NCT02137785|P1|Participant Flow|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660402|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660403|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660404|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660405|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660406|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660705|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660407|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660408|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660409|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660410|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660411|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660412|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660413|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660414|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660415|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660416|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660417|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660418|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660419|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660420|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660421|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660422|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660423|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660424|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660425|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660426|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
664335|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
660427|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660428|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660429|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660430|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660431|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660432|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660433|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660434|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660435|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660436|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660437|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660438|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660439|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660440|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660441|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660442|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660443|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660444|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660445|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660446|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660447|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660448|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660449|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660450|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660451|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660452|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660453|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660536|NCT02137447|O1|Outcome|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
660454|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660455|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660456|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660457|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660458|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660459|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660460|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660461|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660462|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660463|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660464|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660465|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660466|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660467|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660468|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660469|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660470|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660471|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660472|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660473|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660474|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660475|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660476|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660477|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660478|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660479|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660480|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
664336|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
660481|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660482|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660483|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660484|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660485|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660486|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660487|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660488|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660489|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660490|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660491|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660492|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660493|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660494|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660495|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660496|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660497|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660498|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660499|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660500|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660501|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660502|NCT02137785|O2|Outcome|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660503|NCT02137785|O1|Outcome|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660504|NCT02137785|E2|Reported Event|Vehicle|"Topical Solution Vehicle: Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660505|NCT02137785|E1|Reported Event|ALA-PDT|"Aminolevulinic Acid (ALA): 20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light~BLU-U Blue Light Photodynamic Therapy Illuminator: 10 J/cm2 blue light delivered at 10mW/cm2"
660506|NCT02137603|B3|Baseline|Total|Total of all reporting groups
660507|NCT02137603|B2|Baseline|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
660508|NCT02137603|B1|Baseline|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
660537|NCT02137447|E1|Reported Event|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
660510|NCT02137603|P1|Participant Flow|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
660511|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
660512|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
660513|NCT02137603|O2|Outcome|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
660514|NCT02137603|O1|Outcome|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
660515|NCT02137603|E2|Reported Event|Admission|Patients are admitted to the inpatient unit following appendectomy for suppurative appendicitis and treated per the current standard of care.
660516|NCT02137603|E1|Reported Event|Fast Track|"Patients discharged home the same day following appendectomy~Patients discharged home the same day following appendectomy: Patients are discharged to home on the same day following appendectomy with oral antibiotics."
660706|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660517|NCT02137512|B1|Baseline|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660518|NCT02137512|P1|Participant Flow|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660519|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660520|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660521|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660522|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660523|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660538|NCT02137382|B1|Baseline|Sequence Creon N/Creon® or Creon®/Creon N|Participants who were randomized to receive either Creon N or Creon.
660539|NCT02137382|P2|Participant Flow|Sequence: Creon®/Creon N|Subjects first received Creon® for 5 days. After a washout period of 3 to 14 days, they received Creon N for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
664337|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
660524|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660525|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660624|NCT02135445|B1|Baseline|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660526|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660527|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660528|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660529|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660530|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660531|NCT02137512|O1|Outcome|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660532|NCT02137512|E1|Reported Event|Closed-Loop Control System|"A control-to-range automated insulin management system using continuous glucose monitoring (CGM) and subcutaneous insulin pump infusion in individuals with type 1 diabetes in the home environment.~Closed-Loop Control System: The devices that will be used in the Closed-Loop Control System include the following components:~DiAs – a smart-phone medical platform;~Dexcom Dexcom G4 Platinum connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
660533|NCT02137447|B1|Baseline|Treatment Group|Negative Pressure treatment
660534|NCT02137447|P1|Participant Flow|Negative Pressure Wound Therapy|"After the completion of the operation, incisional skin closure was performed using sutures or staples and the wound was then covered with the Negative Pressure Wound therapy Prevena Incision Management System (Kinetic Concepts Inc) as per the manufacturer's instructions of use. Continuous negative pressure was applied at 125 mm Hg.~For inpatients, wounds were assessed every 48 hours by inspection and palpation. The dressing was not routinely removed, but the surrounding skin was assessed for cellulitis. The NPWT dressing was removed between post-operative day 5 and 7."
660535|NCT02137447|O1|Outcome|Treatment Group|Negative Pressure Wound Therapy (NPWT) to closed surgical incision
660540|NCT02137382|P1|Participant Flow|Sequence: Creon N/Creon®|Subjects first received Creon N for 5 days. After a washout period of 3 to 14 days, they received Creon® for 5 days. The Investigator calculated the total number of capsules per day needed to treat the subject with 8000 to <10000 lipase units per kg body weight and day, Capsules of both Creon N and Creon® contain 25000 lipase units.
660541|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
660542|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
660543|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
660544|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
660545|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
660546|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
660547|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
660548|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
660549|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
660550|NCT02137382|O1|Outcome|Creon®|Creon® : active comparator
660551|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
660552|NCT02137382|O1|Outcome|Creon®|Creon®: active comparator
660553|NCT02137382|O2|Outcome|Creon N|Creon N: experimental drug
660558|NCT02136498|B2|Baseline|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
660559|NCT02136498|B1|Baseline|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
660560|NCT02136498|P2|Participant Flow|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
660561|NCT02136498|P1|Participant Flow|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
660562|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
660563|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
660564|NCT02136498|O2|Outcome|Augmented mHealth Self-help + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
660565|NCT02136498|O1|Outcome|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
660566|NCT02136498|E2|Reported Event|mHealth MyMAP + Varenicline|"Participants in the experimental arm received a mHealth program (accessible via smartphone) and a prescription for a standard 12 week course of varenicline.~The mHealth intervention included the same self-help content offered to controls + a) real-time, adaptively-tailored advice for managing nicotine withdrawal symptoms and medication side-effects and b) asynchronous secure messaging with a cessation counselor."
660567|NCT02136498|E1|Reported Event|mHealth Self-help + Varenicline|"Participants in the control arm received standard self-help education delivered via an mHealth program (accessible via smart phone) and a prescription for a standard 12 week course of varenicline.~Standard self-help included topics such as: how to make a quit plan, how to use varenicline, how to manage cravings to smoke, how tot manage nicotine withdrawal and medication side-effects, relapse prevention, etc."
660568|NCT02136238|B3|Baseline|Total|Total of all reporting groups
660569|NCT02136238|B2|Baseline|Experimental Group: Unilateral TR or Wrist-disartic Amputees|Includes groups randomized to receive either TRS Grip 3 voluntary close device or Hosmer 5XA voluntary open device first.
660570|NCT02136238|B1|Baseline|Non-amputee Control Group|non-amputee healthy controls
660571|NCT02136238|P3|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
660684|NCT02135432|O1|Outcome|Ivacaftor|patients randomized to ivacaftor twice daily
660572|NCT02136238|P2|Participant Flow|Voluntary Close Device First Then Voluntary Open Device|Voluntary close device (TRS Grip 3 terminal device) first then voluntary open device (Hosmer 5X hook terminal device)
660573|NCT02136238|P1|Participant Flow|Voluntary Open Device First Then Voluntary Close Device|Voluntary open device (Hosmer 5X hook terminal device) first then voluntary close device (TRS Grip 3 terminal device)
660574|NCT02136238|O3|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
660575|NCT02136238|O2|Outcome|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
660576|NCT02136238|O1|Outcome|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
660577|NCT02136238|O3|Outcome|Non-amputee Controls|This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.
660578|NCT02136238|O2|Outcome|Prosthetic Hand 2 (TRS Grip 3)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2~TRS Grip 3 voluntary closing hook: Voluntary closing prosthetic terminal device (hand)"
660655|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660579|NCT02136238|O1|Outcome|Prosthetic Hand 1 (Hosmer 5XA)|"This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1~Hosmer 5XA voluntary opening hook: Voluntary opening prosthetic terminal device (hand)"
660580|NCT02136238|E3|Reported Event|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
660581|NCT02136238|E2|Reported Event|Voluntary Close (TRS Grip 3)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 2
660582|NCT02136238|E1|Reported Event|Voluntary Open (Hosmer 5XA)|This arm of the study included unilateral transradial amputees who who were assessed while using prosthetic hand 1
660583|NCT02136134|B3|Baseline|Total|Total of all reporting groups
660584|NCT02136134|B2|Baseline|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660585|NCT02136134|B1|Baseline|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660586|NCT02136134|P2|Participant Flow|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660587|NCT02136134|P1|Participant Flow|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660588|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660589|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660590|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660591|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660592|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660593|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660594|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660595|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660596|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660597|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660598|NCT02136134|O2|Outcome|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660599|NCT02136134|O1|Outcome|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
677631|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
660600|NCT02136134|E2|Reported Event|Daratumumab + Bortezomib and Dexamethasone (DVd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) intravenous (IV) infusion weekly for the first 3 cycles, on Day 1 of Cycles 4-8, and then every 4 weeks thereafter, bortezomib SC administration on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660601|NCT02136134|E1|Reported Event|Bortezomib + Dexamethasone (Vd)|Participants received bortezomib subcutaneously (SC) on Days 1, 4, 8, and 11 of each 21-day cycle (8 treatment cycles) and dexamethasone orally (PO) at 20 milligram (mg) on Days 1, 2, 4, 5, 8, 9, 11, and 12 of the first 8 bortezomib treatment cycles.
660602|NCT02136004|B3|Baseline|Total|Total of all reporting groups
660603|NCT02136004|B2|Baseline|Closer VSS - Interventional Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in interventional endovascular cases.~Closer VSS: At the end of a percutaneous interventional endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660604|NCT02136004|B1|Baseline|Closer VSS - Diagnostic Cohort|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomies in diagnostic endovascular cases.~Closer VSS: At the end of a percutaneous diagnostic endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660605|NCT02136004|P1|Participant Flow|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660606|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660607|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660608|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660609|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660610|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660611|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660612|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660613|NCT02136004|O1|Outcome|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660614|NCT02136004|E1|Reported Event|Closer VSS|"Rex Medical Closer Vascular Sealing System to close femoral arteriotomy~Closer VSS: At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis."
660615|NCT02135900|B1|Baseline|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
660616|NCT02135900|P1|Participant Flow|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
660617|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
660618|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
660619|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
660620|NCT02135900|O1|Outcome|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
660621|NCT02135900|E1|Reported Event|Heliox|"Heliox which is a mix of oxygen and helium gase will be administered through a face mask during part of the sleep study.~Heliox: From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines."
660622|NCT02135445|B3|Baseline|Total|Total of all reporting groups
660623|NCT02135445|B2|Baseline|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
677635|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
660625|NCT02135445|P2|Participant Flow|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660626|NCT02135445|P1|Participant Flow|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660627|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660628|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660629|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660630|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660631|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660632|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660633|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660634|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660635|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660636|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660637|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660638|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660639|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660640|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660641|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660642|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660643|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660644|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660645|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660646|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660647|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660685|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
660648|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660649|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660650|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660651|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660652|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660653|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660654|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660656|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660657|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660658|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660659|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660660|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660661|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660662|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660663|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660664|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660665|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660666|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660667|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660668|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660669|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660670|NCT02135445|O2|Outcome|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660671|NCT02135445|O1|Outcome|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660672|NCT02135445|E2|Reported Event|Experimental: Degarelix 80 mg|Degarelix 240 mg, injection, subcutaneously, on Day 1 Week 1 followed by Degarelix 80 mg, injection, subcutaneously, once every 4 weeks beginning on Day 1 Week 5 up to Day 1 Week 21.
660673|NCT02135445|E1|Reported Event|Experimental: TAK-385 120 mg|TAK-385 320 mg, tablets, orally, as loading dose on Day 1 followed by TAK-385 120 mg, tablets, orally, daily as maintenance dose starting from Day 2 up to Day 7 Week 24.
660674|NCT02135432|B3|Baseline|Total|Total of all reporting groups
660675|NCT02135432|B2|Baseline|Placebo|"matching placebo~Placebo"
660676|NCT02135432|B1|Baseline|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
660677|NCT02135432|P2|Participant Flow|Placebo|"matching placebo~Placebo"
660678|NCT02135432|P1|Participant Flow|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
660679|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
660680|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
660681|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
660682|NCT02135432|O1|Outcome|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
660683|NCT02135432|O2|Outcome|Placebo|"matching placebo~Placebo"
660688|NCT02135432|E1|Reported Event|Ivacaftor (VX-770)|"twice a day administration of Ivacaftor: 150mg~Ivacaftor"
660689|NCT02135016|B4|Baseline|Total|Total of all reporting groups
660690|NCT02135016|B3|Baseline|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660691|NCT02135016|B2|Baseline|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660692|NCT02135016|B1|Baseline|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
660693|NCT02135016|P3|Participant Flow|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660694|NCT02135016|P2|Participant Flow|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660695|NCT02135016|P1|Participant Flow|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
660696|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660697|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660698|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
660699|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660700|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660701|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
660702|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660703|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660707|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
660708|NCT02135016|O3|Outcome|0.9% Normal Saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660709|NCT02135016|O2|Outcome|2% Lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660710|NCT02135016|O1|Outcome|1% Lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
660711|NCT02135016|E3|Reported Event|Group C|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
660712|NCT02135016|E2|Reported Event|Group B|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
660713|NCT02135016|E1|Reported Event|Group A|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
660714|NCT02134977|B1|Baseline|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660715|NCT02134977|P1|Participant Flow|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660716|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660717|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660718|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660719|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660720|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660721|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660722|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660723|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660724|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660725|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660726|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660727|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660728|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660729|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660730|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660731|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660793|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660732|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660733|NCT02134977|O1|Outcome|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660734|NCT02134977|E1|Reported Event|Leuprorelin Acetate|Leuprorelin Acetate, 11.25 mg sustained-release injection, subcutaneously, once every 12 weeks as part of daily medical practice were observed for up to 48 weeks.
660735|NCT02134587|B1|Baseline|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
660736|NCT02134587|P1|Participant Flow|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
660737|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Skills of health professionals in fill correctly the adverse drug events form before educational intervention
660767|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660894|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660738|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Skills of health professionals in fill correctly the adverse drug events form after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
660739|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Knowledge of health professionals before the educational intervention regarding pharmacovigilance
660740|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Knowledge of health professionals after multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
660741|NCT02134587|O2|Outcome|Subjects Prior to Educational Intervention|Number of health professionals who had the potential to report adverse drug reaction, before the educational intervention
660742|NCT02134587|O1|Outcome|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
660743|NCT02134587|E1|Reported Event|Subjects Post Educational Intervention|"Multifaceted educational intervention in pharmacovigilance~Multifaceted educational intervention: 1- Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.~2- Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material 3- Distribution of educational material 4- Practical class to explain the correct fill of adverse drug events form 5- Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
660744|NCT02134184|B4|Baseline|Total|Total of all reporting groups
660745|NCT02134184|B3|Baseline|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
660746|NCT02134184|B2|Baseline|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
660747|NCT02134184|B1|Baseline|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~Fluzone® 2012-2013 Formula: This vaccine is given intramuscularly"
660748|NCT02134184|P3|Participant Flow|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly Recent CMV Conversion is defined as: Donor has donated at least once within the recent timeframe (past three years) AND donor's most recent two donations tested CMV antibody positive AND donor had at least two CMV negative donations in the past"
660749|NCT02134184|P2|Participant Flow|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660750|NCT02134184|P1|Participant Flow|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660751|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660752|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660753|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660754|NCT02134184|O3|Outcome|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660755|NCT02134184|O2|Outcome|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660756|NCT02134184|O1|Outcome|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
661039|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
660757|NCT02134184|E3|Reported Event|Recent CMV Converters|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660758|NCT02134184|E2|Reported Event|CMV Positive Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660759|NCT02134184|E1|Reported Event|CMV Negative Group|"Participants will receive Fluzone® 2012-2013 Formula NDC No 498281-012-50~This vaccine is given intramuscularly"
660760|NCT02134119|B3|Baseline|Total|Total of all reporting groups
660761|NCT02134119|B2|Baseline|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660762|NCT02134119|B1|Baseline|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660763|NCT02134119|P2|Participant Flow|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660764|NCT02134119|P1|Participant Flow|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660765|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660766|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
689295|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
660768|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660769|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660770|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660771|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660772|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660773|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660774|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660775|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660776|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660777|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660778|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660779|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660780|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660781|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660782|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660783|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660784|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660785|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660786|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660787|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660788|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660789|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660790|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660791|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660792|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660794|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660795|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660796|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660797|NCT02134119|O2|Outcome|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660798|NCT02134119|O1|Outcome|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660799|NCT02134119|E2|Reported Event|Sugar Pill|"Placebo given 8,000mg/day by mouth~Placebo: Sugar pill manufactured to mimic dietary supplement"
660800|NCT02134119|E1|Reported Event|Echinacea-based Dietary Supplement|"Echinacea-based dietary supplement 8,000mg/day or 16,000mg/day by mouth for 35-days~Echinacea-based dietary supplement: Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth"
660801|NCT02133781|B4|Baseline|Total|Total of all reporting groups
660802|NCT02133781|B3|Baseline|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660803|NCT02133781|B2|Baseline|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660804|NCT02133781|B1|Baseline|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
660805|NCT02133781|P3|Participant Flow|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660806|NCT02133781|P2|Participant Flow|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660807|NCT02133781|P1|Participant Flow|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
660808|NCT02133781|O3|Outcome|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660809|NCT02133781|O2|Outcome|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660810|NCT02133781|O1|Outcome|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
660811|NCT02133781|O3|Outcome|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660812|NCT02133781|O2|Outcome|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660813|NCT02133781|O1|Outcome|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
660814|NCT02133781|E3|Reported Event|Age > 70 Years (Non-twins)|"Participants will receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660815|NCT02133781|E2|Reported Event|Age 18-30 Years (Non-twins)|"Participants will be receive Fluzone® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly"
660816|NCT02133781|E1|Reported Event|Age 8-17 Years (Identical Twins )|"Participants will be randomized to receive either Fluzone® 2009-2010 Formula or Flumist® 2009-2010 Formula~Fluzone® 2009-2010 Formula: This vaccine is given intramuscularly~Flumist® 2009-2010 Formula: This vaccine is given intranasally"
660817|NCT02133664|B3|Baseline|Total|Total of all reporting groups
660818|NCT02133664|B2|Baseline|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
660819|NCT02133664|B1|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
660820|NCT02133664|P2|Participant Flow|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
660821|NCT02133664|P1|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
660822|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
660823|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
660824|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
660825|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
660826|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
660882|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660827|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
660828|NCT02133664|O2|Outcome|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
660829|NCT02133664|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
660830|NCT02133664|E2|Reported Event|Placebo|"placebo oil and placebo lipoic acid~Placebo: placebo lipoic acid and placebo oil"
660831|NCT02133664|E1|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and omega-3 fatty acids~Alpha lipoic acid and omega-3 fatty acids: alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid"
660832|NCT02133534|B1|Baseline|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
660893|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660833|NCT02133534|P1|Participant Flow|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
660834|NCT02133534|O1|Outcome|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
660835|NCT02133534|E1|Reported Event|Atorvastatin|"Subjects will be treated with atorvastatin 10 mg/day for 30 days. The study team will obtain one blood and urine sample at baseline prior to starting atorvastatin therapy, and again after 30 days of drug therapy. The study team will do ultrasound imaging of the arm in which a probe will be placed over the blood vessels to measure the diameter of the artery and how this changes after a blood pressure cuff is inflated and then deflated. Subjects will take one nitroglycerine tablet during the ultrasound imaging.~Atorvastatin"
660836|NCT02133352|B1|Baseline|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660837|NCT02133352|P1|Participant Flow|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660838|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660839|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660840|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660841|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660842|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660843|NCT02133352|O1|Outcome|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: open label/Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660844|NCT02133352|E1|Reported Event|Ranolazine|"Ranolazine- initiated at 500mg twice daily and increased to 1000mg twice daily as tolerated after 2wks; the tolerated dose will be used for the remainder of the Treatment Period.~Ranolazine: Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated"
660845|NCT02133235|B3|Baseline|Total|Total of all reporting groups
660846|NCT02133235|B2|Baseline|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
660847|NCT02133235|B1|Baseline|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
660848|NCT02133235|P2|Participant Flow|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
660849|NCT02133235|P1|Participant Flow|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
660850|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
660851|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
660852|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
660853|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
660854|NCT02133235|O4|Outcome|Right-sided VATS, Conventional Fiberoptic Bronchoscopy Group|patients receiving right-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
660855|NCT02133235|O3|Outcome|Right-sided VATS, Auscultation Group|patients receiving right-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
660856|NCT02133235|O2|Outcome|Left-sided VATS, Conventional Fiberoptic Brochoscopy Group|patients receiving left-sided VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by conventional fiberoptic brochoscopy group
660857|NCT02133235|O1|Outcome|Left-sided VATS, Auscultation Group|patients receiving left-sided vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion of endobronchial blocker, confirmation of endobronchial blocker position by auscultation only
660858|NCT02133235|E2|Reported Event|Auscultation Group|patients receiving vedio-assisted thoracic operations by endobronchial blocker with procedures: endotracheal intubation, insertion endobronchial blocker with auscultation without conventional bronchoscopic reposition
660859|NCT02133235|E1|Reported Event|Conventional Fiberoptic Brochoscopy Group|patients receiving VATS operations with endobronchial blockers with procedures: endotracheal intubation, insertion of endobronchial blocker and auscultation, fiberoptic confirmation and reposition
660860|NCT02133131|B8|Baseline|Total|Total of all reporting groups
660861|NCT02133131|B7|Baseline|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660862|NCT02133131|B6|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660863|NCT02133131|B5|Baseline|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660864|NCT02133131|B4|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660865|NCT02133131|B3|Baseline|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660866|NCT02133131|B2|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660867|NCT02133131|B1|Baseline|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
660868|NCT02133131|P7|Participant Flow|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660869|NCT02133131|P6|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660870|NCT02133131|P5|Participant Flow|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660871|NCT02133131|P4|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660872|NCT02133131|P3|Participant Flow|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660873|NCT02133131|P2|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660874|NCT02133131|P1|Participant Flow|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
660875|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660876|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660877|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660878|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660879|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660880|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660881|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
660960|NCT02132936|E4|Reported Event|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
660883|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660884|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660885|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660886|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660887|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660888|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
660889|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660890|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660891|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660892|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660895|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
660896|NCT02133131|O7|Outcome|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660897|NCT02133131|O6|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660898|NCT02133131|O5|Outcome|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660899|NCT02133131|O4|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660900|NCT02133131|O3|Outcome|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660901|NCT02133131|O2|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660902|NCT02133131|O1|Outcome|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
660903|NCT02133131|E7|Reported Event|GT3: C Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660904|NCT02133131|E6|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 12 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 12 weeks.
660905|NCT02133131|E5|Reported Event|GT3: NC Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT3 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660906|NCT02133131|E4|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 8 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 8 weeks.
660907|NCT02133131|E3|Reported Event|GT1: C Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 C participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660908|NCT02133131|E2|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 6 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 6 weeks.
660909|NCT02133131|E1|Reported Event|GT1: NC Grazoprevir/Elbasvir + SOF 4 Weeks|HCV GT1 NC participants took grazoprevir 100 mg + elbasvir 50 mg FDC with SOF 400 mg for 4 weeks.
660910|NCT02132949|B3|Baseline|Total|Total of all reporting groups
660911|NCT02132949|B2|Baseline|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660912|NCT02132949|B1|Baseline|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660961|NCT02132936|E3|Reported Event|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
660962|NCT02132936|E2|Reported Event|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
661040|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
660913|NCT02132949|P2|Participant Flow|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660914|NCT02132949|P1|Participant Flow|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
661049|NCT02131636|P2|Participant Flow|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661050|NCT02131636|P1|Participant Flow|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
660915|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660916|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660917|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660918|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660919|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660920|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660963|NCT02132936|E1|Reported Event|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
660921|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660922|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
661051|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
660923|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660924|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660925|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660926|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660927|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660928|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660964|NCT02132832|B3|Baseline|Total|Total of all reporting groups
660965|NCT02132832|B2|Baseline|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
661041|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
660929|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660930|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660931|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660932|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660933|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660934|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660935|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660936|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660966|NCT02132832|B1|Baseline|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660967|NCT02132832|P2|Participant Flow|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660937|NCT02132949|O2|Outcome|FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660938|NCT02132949|O1|Outcome|ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 mg/m^2 (as an IV bolus over 3-5min or as an infusion over 15-30min) q2w and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion qw for 12 weeks. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660939|NCT02132949|E2|Reported Event|Cohort B: FEC, Docetaxel, Pertuzumab, Trastuzumab|FEC: 5-fluorouracil, epirubicin and cyclophosphamide. Participants received 5-fluorouracil 500mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, epirubicin 100mg/m^2 (as an IV bolus over 3-5min or as an infusion over 3-5min, in accordance with local policy) q3w, and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q3w for 4 cycles, followed by docetaxel (with starting dose of 75mg/m^2 in Cycle 5, then 100mg/m^2 for Cycles 6-8) q3w for 4 cycles. Pertuzumab 840 mg loading dose IV, then 420mg IV q3w and trastuzumab 8 mg/kg loading dose, then 4mg/kg q3w were given along with doectaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660940|NCT02132949|E1|Reported Event|Cohort A: ddAC, Paclitaxel, Pertuzumab, Trastuzumab|ddAC: dose dense doxorubicin and cyclophosphamide. Participants received doxorubicin 60 milligrams per square meter (mg/m^2; as an intravenous [IV] bolus over 3-5 minutes [min] or as an infusion over 15-30min) once in every 2 weeks (q2w) and cyclophosphamide 600mg/m^2 (IV bolus over 3-5min or as an infusion, in accordance with local policy) q2w, for 4 cycles followed by paclitaxel 80mg/m^2 IV infusion once weekly (qw) for 12 weeks. Pertuzumab 840 milligrams (mg) loading dose IV, then 420mg IV q3w and trastuzumab 8 milligrams per kilogram (mg/kg) loading dose, then 4mg/kg q3w were given along with paclitaxel for 4 cycles (8 cycles of chemotherapy in total prior to surgery). Following surgery, participants received further adjuvant pertuzumab and trastuzumab q3w (13 cycles), such that a total of 17 cycles of pertuzumab and trastuzumab therapy are given during the study.
660941|NCT02132936|B5|Baseline|Total|Total of all reporting groups
660942|NCT02132936|B4|Baseline|Gel Vehicle|"Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks~Gel vehicle"
660943|NCT02132936|B3|Baseline|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
660944|NCT02132936|B2|Baseline|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
660945|NCT02132936|B1|Baseline|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
660946|NCT02132936|P4|Participant Flow|Gel Vehicle|Gel vehicle, 60 g per bottle, applied once daily up to 12 weeks
660947|NCT02132936|P3|Participant Flow|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
660948|NCT02132936|P2|Participant Flow|Aerosol Foam Vehicle|Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks
660949|NCT02132936|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
660950|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
660951|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
660952|NCT02132936|O2|Outcome|Aerosol Foam Vehicle|"Aerosol foam vehicle, 60 g per can, applied once daily for up to 12 weeks~Aerosol foam vehicle"
660953|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
660954|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
660955|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
660956|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|"Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks~Calcipotriol BDP gel"
660957|NCT02132936|O1|Outcome|LEO 90100|"LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks~LEO 90100 aerosol foam"
660958|NCT02132936|O2|Outcome|Calcipotriol BDP Gel|Calcipotriol BDP gel, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per bottle, applied once daily up to 12 weeks
660959|NCT02132936|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol (as hydrate) 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate), 60 g per can, applied once daily up to 12 weeks
660968|NCT02132832|P1|Participant Flow|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660969|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660970|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660971|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660972|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660973|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660974|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660975|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
661052|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
660976|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660977|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660978|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660979|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660980|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660981|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660982|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660983|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660984|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660985|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660986|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660987|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660988|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660989|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660990|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660991|NCT02132832|O2|Outcome|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660992|NCT02132832|O1|Outcome|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660993|NCT02132832|E2|Reported Event|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
660994|NCT02132832|E1|Reported Event|Buspirone|Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
660995|NCT02132767|B3|Baseline|Total|Total of all reporting groups
660996|NCT02132767|B2|Baseline|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661029|NCT02132117|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
661030|NCT02132117|P2|Participant Flow|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
661031|NCT02132117|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrochloride (HCL) Cream 1.0% applied to the face once daily for 29 days.
661032|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
661033|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
661034|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
660997|NCT02132767|B1|Baseline|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661053|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661054|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
661055|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661056|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
661057|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661058|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
660998|NCT02132767|P2|Participant Flow|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
660999|NCT02132767|P1|Participant Flow|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661000|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661001|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661002|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661003|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661004|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661035|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
661036|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
661005|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661006|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661007|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661008|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661009|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661010|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661011|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661012|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661037|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
661038|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
686633|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
661013|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661014|NCT02132767|O2|Outcome|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661015|NCT02132767|O1|Outcome|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661016|NCT02132767|E2|Reported Event|Rhythm Control|"Patients assigned to an initial strategy of rhythm control will be treated with amiodarone alone or amiodarone plus direct current (DC) cardioversion if amiodarone alone does not eliminate AF within 48 hours. For patients who are hemodynamically stable but remain in AF, at least 24 hours of amiodarone should be administered before cardioversion is attempted. Cardioversion should be attempted, if possible, prior to the 48 hour duration to avoid the need for a TEE guided approach.~If AF has been present for ≥ 48 hours and the patient has not been therapeutically anticoagulated, cardioversion should be TEE guided. When deemed to be clinically appropriate, patients in the rhythm control arm may also be treated with a rate control medication (e.g. beta blocker). In particular, a rate control medication may be indicated at the onset of AF."
661017|NCT02132767|E1|Reported Event|Rate Control|"Patients randomized to this arm will be treated with an initial strategy of rate control. The target heart rate is < 100 beats per minute at rest. The treating clinician will choose agents from the list of rate control medications below and employ these medications (singly or in combination) to achieve rate control. A patient who presents with AF and slow ventricular response rate (<60 beats per minute) may still be randomized to the rate control strategy; in such instances, rate control agents may be withheld or administered in low doses. Dose ranges, as defined in guidelines, for each of the rate control agents need to be adhered to. Simultaneous use of more than one of the categories of rate control agents should be done with caution due to risk of bradycardia.~Rate Control Agents:~Beta blockers (e.g. metoprolol, atenolol, carvedilol, esmolol) Calcium channel blockers (nondihydropyridine) (e.g. diltiazem, verapamil) Digoxin"
661018|NCT02132611|B1|Baseline|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
661019|NCT02132611|P1|Participant Flow|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
661020|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
661021|NCT02132611|O1|Outcome|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
661022|NCT02132611|E1|Reported Event|Diamondback 360® Coronary OAS Micro Crown|Diamondback 360® Coronary OAS Micro Crown: The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
661023|NCT02132572|B1|Baseline|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
661024|NCT02132572|P1|Participant Flow|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
661025|NCT02132572|O1|Outcome|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
661026|NCT02132572|E1|Reported Event|Natrelle BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
661027|NCT02132117|B3|Baseline|Total|Total of all reporting groups
661028|NCT02132117|B2|Baseline|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
661042|NCT02132117|O2|Outcome|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
661043|NCT02132117|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
661044|NCT02132117|E2|Reported Event|Vehicle|Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
661045|NCT02132117|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days.
661046|NCT02131636|B3|Baseline|Total|Total of all reporting groups
661047|NCT02131636|B2|Baseline|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661048|NCT02131636|B1|Baseline|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
661059|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661060|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
661061|NCT02131636|O2|Outcome|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661062|NCT02131636|O1|Outcome|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
661063|NCT02131636|E2|Reported Event|Vehicle|Vehicle to AGN-199201 applied to the face once daily for 29 days.
661064|NCT02131636|E1|Reported Event|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
661065|NCT02131532|B1|Baseline|Intervention Group|Baseline characteristics of eight participants who completed all treatment sessions
661066|NCT02131532|P1|Participant Flow|Psychological Intervention|All participants were enrolled in this group, receiving a psychological intervention for the treatment of post-stroke fatigue.
661067|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661068|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661069|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661070|NCT02131532|O1|Outcome|Intervention Group|This outcome presents the recruitment process. However, only eight participants who completed all treatment sessions were included for further analysis of clinical outcomes.
661071|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661072|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661073|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661074|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661075|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661076|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661077|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661078|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661079|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661080|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661081|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661082|NCT02131532|O1|Outcome|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661083|NCT02131532|E1|Reported Event|Intervention Group|Eight participants who completed all treatment sessions were included for data analysis
661084|NCT02131402|B1|Baseline|Enfilcon A / Omafilcon A/Ocufilcon D/Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contralateral eye. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
661085|NCT02131402|P1|Participant Flow|Overall Participants Flow|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A/ocufilcon D/methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A)/(ocufilcon D)/(methafilcon A)in the contra lateral eye."
661086|NCT02131402|O2|Outcome|Methafilcon A|Participants vision tested both eyes wearing Methafilcon A, prior to dispensing contralateral pairs.
661087|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
661088|NCT02131402|O2|Outcome|Ocufilcon D|Participants vision tested both eyes wearing ocufilcon D, prior to dispensing contralateral pairs.
661089|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
661090|NCT02131402|O2|Outcome|Omafilcon A|Participants vision tested both eyes wearing omafilcon A, prior to dispensing contralateral pairs.
661091|NCT02131402|O1|Outcome|Enfilcon A|Participants vision tested both eyes wearing enfilcon A, prior to dispensing contralateral pairs.
661092|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
661093|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
661094|NCT02131402|O2|Outcome|Ocufilcon D|Participants surveyed at 1 hour post settling, wearing Ocufilcon D in contralateral eye.
661095|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at 1 hour post settling, wearing Enfilcon A in one eye.
661096|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after1 hour wearing Omafilcon A in contralateral eye.
661097|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour wearing Enfilcon A in one eye.
661098|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed at baseline, wearing Methafilcon A in contralateral eye.
661099|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye.
661100|NCT02131402|O2|Outcome|Ocufilcon D|Surveyed after insertion at baseline, wearing Ocufilcon D in contralateral eye.
661101|NCT02131402|O1|Outcome|Enfilcon A|Surveyed after insertion at baseline, wearing Enfilcon A in one eye.
661102|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in contralateral eye
661103|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
661104|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling, wearing Methafilcon A in contralateral eye.
661105|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling, wearing Enfilcon A in one eye.
661106|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling, wearing Ocufilcon D in contralateral eye.
661107|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling, wearing Enfilcon A in one eye.
661108|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling, wearing Omafilcon A in contralateral eye
661109|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling wearing Enfilcon A in one eye.
661110|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling. Push up test, wearing Methafilcon A in contralateral eye.
661111|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
661112|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Push up test, wearing Ocufilcon D in contralateral eye.
661113|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
661114|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling. Push up test, wearing Omafilcon A in contralateral eye.
661115|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Push up test, wearing Enfilcon A in one eye.
661116|NCT02131402|O2|Outcome|Methafilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
661117|NCT02131402|O1|Outcome|Enfilcon A|Assessed at 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
661118|NCT02131402|O2|Outcome|Ocufilcon D|Assessed after 1 hour post settling. Post-blink movement, wearing Ocufilcon D in contralateral eye.
661119|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye
661120|NCT02131402|O2|Outcome|Omafilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Omafilcon A in contralateral eye.
661121|NCT02131402|O1|Outcome|Enfilcon A|Assessed after 1 hour post settling. Post-blink movement, wearing Enfilcon A in one eye.
661122|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye, surveyed at 1 hour post settling.
661123|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye, surveyed at 1 hour post settling.
661124|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in contralateral eye. Surveyed after 1 hour post settling.
661125|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling.
661126|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
661127|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
661128|NCT02131402|O2|Outcome|Methafilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Methafilcon A in the contralateral eye.
661129|NCT02131402|O1|Outcome|Enfilcon A|Subject surveyed after insertion of each lens for Pair #3 wearing Enfilcon A in one eye
661130|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed at insertion of each lens Pair #2.
661131|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed at insertion of each lens Pair #2.
661132|NCT02131402|O2|Outcome|Omafilcon A|Subject after insertion of Pair #1 at baseline wearing Omafilcon A in the contralateral eye.
661133|NCT02131402|O1|Outcome|Enfilcon A|Subject after insertion of Pair #1 at baseline wearing Enfilcon A in one eye
661134|NCT02131402|O2|Outcome|Methafilcon A|Participants surveyed after 1 post settling hour, wearing Methafilcon A in the contra lateral eye.
661135|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
661136|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after 1 hour post settling for Pair #2.
661137|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour post settling for Pair #2
661138|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour post settling, wearing Omafilcon A in contralateral eye
661139|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour post settling, wearing Enfilcon A in one eye
661140|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contra lateral eye. Participants surveyed at insertion.
661141|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Participants surveyed at insertion.
661142|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed at baseline, wearing Omafilcon A in the contra lateral eye.
661143|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed at baseline, wearing Enfilcon A in one eye
661144|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contra lateral eye. Surveyed after insertion of each lens Pair #2 (at insertion).
661145|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after insertion of each lens Pair #2 (at insertion).
661146|NCT02131402|O2|Outcome|Methafilcon A|Wearing Methafilcon A in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
661147|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal Pair #3.
661148|NCT02131402|O2|Outcome|Ocufilcon D|Wearing Ocufilcon D in the contralateral eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2
661149|NCT02131402|O1|Outcome|Enfilcon A|Wearing Enfilcon A in one eye. Surveyed after 1 hour of lens wear for each lens at lens removal for Pair #2.
661150|NCT02131402|O2|Outcome|Omafilcon A|Participants surveyed after 1 hour of lens wear. Wearing Omafilcon A in the contralateral eye.
661151|NCT02131402|O1|Outcome|Enfilcon A|Participants surveyed after 1 hour of lens wear. Wearing Enfilcon A in one eye.
661152|NCT02131402|E3|Reported Event|Enfilcon A / Methafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~methafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye."
695753|NCT01886781|O2|Outcome|Placebo|Controls Crytalline cellulose powder
661153|NCT02131402|E2|Reported Event|Enfilcon A / Ocufilcon D|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~ocufilcon D: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye."
661154|NCT02131402|E1|Reported Event|Enfilcon A / Omafilcon A|"Participants wear a pair of lenses, with a test lens in one eye and a control lens in the contra lateral eye. After approximately 1 hour of lens wear, the lenses will be removed and the next pair will be inserted. This will be repeated for a total of three pairs of lenses.~omafilcon A: Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye."
661155|NCT02131311|B1|Baseline|Pessary|disposable, single-use pessary
661156|NCT02131311|P1|Participant Flow|Pessary|disposable, single-use pessary
661157|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
661158|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
661159|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
661160|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
661161|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
661162|NCT02131311|O1|Outcome|Pessary|disposable, single-use pessary
661163|NCT02131311|O1|Outcome|Pessary|"disposable, single-use pessary~disposable, single-use pessary"
661164|NCT02131311|E1|Reported Event|Pessary|disposable, single-use pessary
661165|NCT02131233|B3|Baseline|Total|Total of all reporting groups
661166|NCT02131233|B2|Baseline|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661167|NCT02131233|B1|Baseline|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661168|NCT02131233|P2|Participant Flow|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661169|NCT02131233|P1|Participant Flow|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661170|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661171|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661172|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661173|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661174|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661175|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661176|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661177|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661178|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661179|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661180|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661181|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661182|NCT02131233|O2|Outcome|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661183|NCT02131233|O1|Outcome|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661184|NCT02131233|E2|Reported Event|Raltegravir|Raltegravir 400 mg tablet orally twice daily plus placebo to reformulated raltegravir 2 tablets orally once daily plus TRUVADA™ orally once daily for 96 weeks
661185|NCT02131233|E1|Reported Event|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily plus placebo to raltegravir 1 tablet orally twice daily plus TRUVADA™ orally once daily for 96 weeks
661186|NCT02131064|B3|Baseline|Total|Total of all reporting groups
661187|NCT02131064|B2|Baseline|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661258|NCT02130284|E1|Reported Event|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661259|NCT02130193|B3|Baseline|Total|Total of all reporting groups
661188|NCT02131064|B1|Baseline|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661189|NCT02131064|P2|Participant Flow|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661190|NCT02131064|P1|Participant Flow|TCH + P|Participants received pertuzumab 840 milligrams (mg) (loading dose) and 420 mg (maintenance dose) intravenous (IV) infusion, trastuzumab 8 milligrams per kilogram (mg/kg) (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 milligrams per square meter (mg/m^2) IV infusion and carboplatin at a dose to achieve an area under the curve (AUC) of 6 milligrams per milliliter* minute (mg/mL*min) IV infusion every 3 weeks (q3w) for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661191|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661192|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661193|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661194|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661195|NCT02131064|O1|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661196|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661197|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661198|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661199|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661200|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661201|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661202|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661203|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661339|NCT02129777|P1|Participant Flow|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661204|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661205|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661206|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661207|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661208|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661209|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661210|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661211|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661212|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661213|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661214|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661215|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661216|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661620|NCT02126670|P4|Participant Flow|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
661217|NCT02131064|O2|Outcome|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661218|NCT02131064|O1|Outcome|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661219|NCT02131064|E2|Reported Event|T-DM1 + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab emtansine 3.6 mg/kg IV infusion q3w for a total of 18 cycles (6 cycles of neoadjuvant period and 12 cycles of adjuvant period).
661220|NCT02131064|E1|Reported Event|TCH + P|Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion, trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion, docetaxel 75 mg/m^2 IV infusion and carboplatin at a dose to achieve an AUC of 6 mg/mL*min IV infusion q3w for 6 cycles in neoadjuvant period. Participants received pertuzumab 840 mg (loading dose) and 420 mg (maintenance dose) IV infusion followed by trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w for rest of the cycles (12 cycles) in adjuvant period (up to a total of 18 cycles).
661221|NCT02130999|B1|Baseline|Overall Number of Baseline Participants|14 subjects total participated in the study
661222|NCT02130999|P2|Participant Flow|Sequence B|"Single I.V. dose of tasimelteon 2 mg on Day 1~Single oral dose of tasimelteon 20 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
661223|NCT02130999|P1|Participant Flow|Sequence A|"Single oral dose of tasimelteon 20 mg on Day 1~Single I.V. dose of tasimelteon 2 mg on Day 6~tasimelteon 20 mg capsule~tasimelteon 2 mg I.V."
661224|NCT02130999|O3|Outcome|All Subjects|
661225|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
661226|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
661227|NCT02130999|O3|Outcome|All Subjects|
661228|NCT02130999|O2|Outcome|Tasimelteon 2mg IV|
661229|NCT02130999|O1|Outcome|Tasimelteon 20mg Oral|
661230|NCT02130999|O2|Outcome|IV (2 mg)|
661231|NCT02130999|O1|Outcome|Oral (20 mg)|
661232|NCT02130999|O2|Outcome|IV (2 mg)|
661233|NCT02130999|O1|Outcome|Oral (20 mg)|
661234|NCT02130999|O2|Outcome|IV (2 mg)|
661235|NCT02130999|O1|Outcome|Oral (20 mg)|
661236|NCT02130999|O2|Outcome|IV (2 mg)|
661237|NCT02130999|O1|Outcome|Oral (20 mg)|
661238|NCT02130999|O2|Outcome|IV (2 mg)|
661239|NCT02130999|O1|Outcome|Oral (20 mg)|
661240|NCT02130999|O2|Outcome|IV (2 mg)|
661241|NCT02130999|O1|Outcome|Oral (20 mg)|
661242|NCT02130999|O2|Outcome|IV (2 mg)|
661243|NCT02130999|O1|Outcome|Oral (20 mg)|
661244|NCT02130999|O1|Outcome|Absolute Bioavailability|
661245|NCT02130999|E3|Reported Event|All Subjects|
661246|NCT02130999|E2|Reported Event|Tasimelteon 2mg IV|
661247|NCT02130999|E1|Reported Event|Tasimelteon 20mg Oral|
661248|NCT02130284|B1|Baseline|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661249|NCT02130284|P1|Participant Flow|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661250|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661251|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661252|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661253|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661254|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661255|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661256|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661257|NCT02130284|O1|Outcome|Predictive Low Glucose Management (PLGM)|"To evaluate the safety of the Predictive Low Glucose Management feature in insulin pump algorithm with the Enlite 3 Sensor~Predictive Low Glucose Management Feature in Insulin pump: All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL."
661340|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
698488|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
661260|NCT02130193|B2|Baseline|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661261|NCT02130193|B1|Baseline|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661262|NCT02130193|P3|Participant Flow|Part B: 52-week Double-blind Period: DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661263|NCT02130193|P2|Participant Flow|Part B: 52-week Double-blind Period: Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661264|NCT02130193|P1|Participant Flow|Part A: 4-week Open-label Period: DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661265|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661266|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661267|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661268|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661269|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661270|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661271|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661272|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661273|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661274|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661621|NCT02126670|P3|Participant Flow|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
661275|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661276|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661277|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661513|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661278|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661279|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661280|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661281|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661282|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661283|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661284|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661285|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661286|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661287|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661288|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661289|NCT02130193|O1|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661290|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661291|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661292|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661293|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661294|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661295|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661296|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661514|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661297|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661298|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661299|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661300|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661301|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661302|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661303|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661304|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661305|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661306|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661307|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661308|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661309|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661310|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661311|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661312|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661313|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661622|NCT02126670|P2|Participant Flow|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
661314|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661315|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661515|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661316|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661317|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661318|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661319|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661320|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661321|NCT02130193|O2|Outcome|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661322|NCT02130193|O1|Outcome|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661323|NCT02130193|O1|Outcome|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661324|NCT02130193|E3|Reported Event|DNX 75 mg|Participants received one immediate release tablet of danirixin (DNX) 75 mg BID with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661325|NCT02130193|E2|Reported Event|Placebo|Participants received one tablet of placebo twice daily with food and water for 52 weeks. It was administered on top of the participant’s current standard of care. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661326|NCT02130193|E1|Reported Event|DNX 50 mg|Participants received one immediate release tablet of danirixin (DNX) 50 mg BID with food and water for 2 weeks. Participants were permitted to continue taking inhaled maintenance medications. Rescue medications for acute symptoms were also permitted (e.g. short acting bronchodilators).
661327|NCT02129777|B6|Baseline|Total|Total of all reporting groups
661328|NCT02129777|B5|Baseline|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661329|NCT02129777|B4|Baseline|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661330|NCT02129777|B3|Baseline|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661331|NCT02129777|B2|Baseline|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661332|NCT02129777|B1|Baseline|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661333|NCT02129777|P7|Participant Flow|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
661334|NCT02129777|P6|Participant Flow|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
661335|NCT02129777|P5|Participant Flow|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661336|NCT02129777|P4|Participant Flow|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661623|NCT02126670|P1|Participant Flow|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
661337|NCT02129777|P3|Participant Flow|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661338|NCT02129777|P2|Participant Flow|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661974|NCT02121860|P1|Participant Flow|Normal Hepatic Function|Medically healthy as determined by the investigator
661341|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661342|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661343|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661344|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661345|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661346|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661347|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661348|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661349|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661350|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661351|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661352|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661353|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661354|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661355|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661356|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661357|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661358|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661359|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661360|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661361|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661362|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661624|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
661363|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661364|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661365|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661366|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661975|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
661367|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661368|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661369|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661370|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661371|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661372|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661373|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661374|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661375|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661376|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661377|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661378|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661379|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661380|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661381|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661382|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661383|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661384|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661385|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661386|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661387|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661388|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661625|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
686862|NCT01940146|B2|Baseline|SPARC1310 I|Baseline characteristics: Age
661389|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661390|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661391|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661392|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661393|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661394|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661395|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661396|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661397|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661398|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661399|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661400|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661401|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661402|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661403|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661404|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661405|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661406|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661407|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661408|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661409|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661410|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661411|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661412|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661413|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661414|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661626|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
664338|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
661415|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661416|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661417|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661418|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661419|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661420|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661421|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661422|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661423|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661424|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661425|NCT02129777|O5|Outcome|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661426|NCT02129777|O4|Outcome|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661427|NCT02129777|O3|Outcome|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661428|NCT02129777|O2|Outcome|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661429|NCT02129777|O1|Outcome|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661430|NCT02129777|E12|Reported Event|Follow-up: Namilumab 150 mg|Participants who received namilumab 150 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
661431|NCT02129777|E11|Reported Event|Follow-up Period: Namilumab 80 mg|Participants who received namilumab 80 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
661432|NCT02129777|E10|Reported Event|Follow-up Period: Namilumab 50 mg|Participants who received namilumab 50 mg injections during the double-blind treatment were to be followed-up after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
661433|NCT02129777|E9|Reported Event|Follow-up Period: Namilumab 20 mg|Participants who received namilumab 20 mg injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
661434|NCT02129777|E8|Reported Event|Follow-up Period: Placebo|Participants who received namilumab-matching placebo injections during the double-blind treatment were to be followed-up for 18 weeks after the last dose of study drug - whether administered in the double-blind period or open-label extension period.
661435|NCT02129777|E7|Reported Event|Open-Label Period: Namilumab 150 mg|Namilumab 150 mg, single injection, subcutaneously from Week 8 and then every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
661436|NCT02129777|E6|Reported Event|Open-Label Period: Namilumab 80 mg|Namilumab 80 mg, single injection, subcutaneously, every 4 weeks for 52 weeks during the open-label period on the basis of treatment response.
661437|NCT02129777|E5|Reported Event|Double-Blind Period: Namilumab 150 mg|Namilumab 300 mg injection (2 separate injections of 150 mg) subcutaneously on Day 1, followed by namilumab 150 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661438|NCT02129777|E4|Reported Event|Double-Blind Period: Namilumab 80 mg|Namilumab 160 mg injection (2 separate injections of 80 mg) subcutaneously on Day 1, followed by namilumab 80 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661439|NCT02129777|E3|Reported Event|Double-Blind Period: Namilumab 50 mg|Namilumab 100 mg injection (2 separate injections of 50 mg) subcutaneously on Day 1, followed by namilumab 50 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661440|NCT02129777|E2|Reported Event|Double-Blind Period: Namilumab 20 mg|Namilumab 40 milligram (mg) injection (2 separate injections of 20 mg) subcutaneously on Day 1, followed by namilumab 20 mg, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
664339|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
661441|NCT02129777|E1|Reported Event|Double-Blind Period: Placebo|Namilumab-matching placebo solution (2 separate injections) subcutaneously on Day 1, followed by namilumab-matching placebo, single injection, subcutaneously at Weeks 2, 6 and 10 during the double-blind period.
661442|NCT02129725|B3|Baseline|Total|Total of all reporting groups
661443|NCT02129725|B2|Baseline|Placebo|Subjects consented for the biopsy substudy and randomized
661444|NCT02129725|B1|Baseline|Sildenafil|Subjects consented for the biopsy substudy and randomized
661445|NCT02129725|P2|Participant Flow|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
661516|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661446|NCT02129725|P1|Participant Flow|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
661447|NCT02129725|O2|Outcome|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
661448|NCT02129725|O1|Outcome|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
661449|NCT02129725|E2|Reported Event|Placebo|"In the parent study, subjects are randomized to matching placebo~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
661450|NCT02129725|E1|Reported Event|Sildenafil|"In the parent study, subjects are randomized to sildenafil 25 mg tid.~muscle biopsy: A muscle biopsy will be obtained before and after the hyperinsulinemic clamp in the parent study. The purpose of the biopsy will be to assess Akt signaling."
661451|NCT02129608|B4|Baseline|Total|Total of all reporting groups
661452|NCT02129608|B3|Baseline|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661453|NCT02129608|B2|Baseline|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661454|NCT02129608|B1|Baseline|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
661455|NCT02129608|P3|Participant Flow|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661456|NCT02129608|P2|Participant Flow|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661457|NCT02129608|P1|Participant Flow|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
661458|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661459|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661460|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
661461|NCT02129608|O3|Outcome|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661462|NCT02129608|O2|Outcome|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661463|NCT02129608|O1|Outcome|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
661464|NCT02129608|E3|Reported Event|LLLT and Lorcaserin|"LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661465|NCT02129608|E2|Reported Event|Lorcaserin|"locarserin monotherapy - 10 mg, twice daily for 12 weeks~Lorcaserin: 10 mg pills twice daily for 12 weeks."
661466|NCT02129608|E1|Reported Event|LLLT|"Low Level Laser Therapy (LLLT) once a week for 12 weeks~LLLT: The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks."
661467|NCT02129192|B3|Baseline|Total|Total of all reporting groups
661468|NCT02129192|B2|Baseline|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:~R - T - T - R.~The treatments were administered following an overnight fast of at least 10 hours."
661627|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
686863|NCT01940146|B1|Baseline|SPARC Placebo|Baseline characteristics: Age
661469|NCT02129192|B1|Baseline|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:~T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.~Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
661470|NCT02129192|P2|Participant Flow|Sequence RTTR|"Subjects were treated telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 4:~R - T - T - R.~The treatments were administered following an overnight fast of at least 10 hours."
661471|NCT02129192|P1|Participant Flow|Sequence TRRTT|"Subjects were treated with telmisartan 80 mg (T80), amlodipine 5 mg (A5) and hydrochlorothiazide (HCTZ) 12.5 mg (H12.5 mg) in the following order from period 1 to period 5:~T (test product: T80/A5/H12.5 mg fixed dose combination (FDC) tablet) - R (reference products: T80/H12.5 mg FDC tablet and A5 mg capsule) - R - T - T.~Treatment periods 1 to 4 were administered following an overnight fast of at least 10 hours, in treatment period 5 after an overnight fast of at least 10 hours, a Japanese-style breakfast was served 30 minutes before drug administration"
661472|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
661473|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
661474|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
661475|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
661476|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
661477|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
661478|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
661479|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
661480|NCT02129192|O2|Outcome|T80/A5/H12.5 FDC Fasted|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fasted condition
661481|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC Fed|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet in fed condition
661482|NCT02129192|O2|Outcome|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
661483|NCT02129192|O1|Outcome|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
661484|NCT02129192|E3|Reported Event|Total.|All participants randomised into the study.
661485|NCT02129192|E2|Reported Event|T80/H12.5 FDC + A5 Capsule|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet and Amlodipine 5 mg capsule
661486|NCT02129192|E1|Reported Event|T80/A5/H12.5 mg FDC|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg fixed dose combination tablet
661487|NCT02129062|B1|Baseline|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
661488|NCT02129062|P1|Participant Flow|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
661489|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
661490|NCT02129062|O1|Outcome|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
661491|NCT02129062|E1|Reported Event|Treatment (Ibrutinib)|Ibrutinib 560 mg orally daily on days 1-28. Courses repeat every 4 weeks.
661492|NCT02128867|B4|Baseline|Total|Total of all reporting groups
661493|NCT02128867|B3|Baseline|Bouncing|"bouncing . intervention to relax the infant~bouncing"
661494|NCT02128867|B2|Baseline|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
661495|NCT02128867|B1|Baseline|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
661496|NCT02128867|P3|Participant Flow|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
661497|NCT02128867|P2|Participant Flow|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
661498|NCT02128867|P1|Participant Flow|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
661499|NCT02128867|O3|Outcome|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
661500|NCT02128867|O2|Outcome|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
661501|NCT02128867|O1|Outcome|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
661502|NCT02128867|E3|Reported Event|Bouncing|"bouncing as control group. intervention to relax the infant~bouncing"
661503|NCT02128867|E2|Reported Event|Bouncing Combined With AAD|"airway clearance technique for infants : bouncing combined with AAD~bouncing combined with AAD"
661504|NCT02128867|E1|Reported Event|Assisted Autogenic Drainage (AAD)|"airway clearance technique for infants :Assisted Autogenic Drainage~Assisted Autogenic Drainage (AAD)"
661505|NCT02128542|B3|Baseline|Total|Total of all reporting groups
661506|NCT02128542|B2|Baseline|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661507|NCT02128542|B1|Baseline|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661508|NCT02128542|P2|Participant Flow|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661509|NCT02128542|P1|Participant Flow|SOF+RBV 12 Weeks (TN)|Treatment-naive (TN) participants received sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661510|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661511|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661512|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661976|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
661517|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (All)|All participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661518|NCT02128542|O2|Outcome|SOF+RBV 12 Weeks (TE)|Treatment-experienced participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661519|NCT02128542|O1|Outcome|SOF+RBV 12 Weeks (TN)|Treatment-naive participants received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661520|NCT02128542|E1|Reported Event|SOF+RBV 12 Weeks (All Participants)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks.
661521|NCT02128490|B6|Baseline|Total|Total of all reporting groups
661522|NCT02128490|B5|Baseline|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661523|NCT02128490|B4|Baseline|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661524|NCT02128490|B3|Baseline|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661525|NCT02128490|B2|Baseline|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661526|NCT02128490|B1|Baseline|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661527|NCT02128490|P5|Participant Flow|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661528|NCT02128490|P4|Participant Flow|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661529|NCT02128490|P3|Participant Flow|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661530|NCT02128490|P2|Participant Flow|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661531|NCT02128490|P1|Participant Flow|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661532|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661533|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661534|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661535|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661536|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661537|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661628|NCT02126670|O4|Outcome|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
664340|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
661538|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661539|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661540|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661541|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661542|NCT02128490|O5|Outcome|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661977|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
661543|NCT02128490|O4|Outcome|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661544|NCT02128490|O3|Outcome|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661545|NCT02128490|O2|Outcome|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661546|NCT02128490|O1|Outcome|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661547|NCT02128490|E5|Reported Event|Febuxostat XR 80 mg|Febuxostat XR 80 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661548|NCT02128490|E4|Reported Event|Febuxostat IR 80 mg|Febuxostat IR 80 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661549|NCT02128490|E3|Reported Event|Febuxostat XR 40 mg|Febuxostat Extended Release (XR) 40 mg over-encapsulated capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661550|NCT02128490|E2|Reported Event|Febuxostat IR 40 mg|Febuxostat Immediate Release (IR) 40 mg over-encapsulated tablet, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661551|NCT02128490|E1|Reported Event|Placebo|Febuxostat placebo-matching capsule, orally, once daily, and colchicine 0.6 mg tablet, orally, every other day, or, naproxen 250 mg tablets, orally, twice a day and lansoprazole 15 mg capsule, orally once daily, for 3 months.
661552|NCT02127567|B1|Baseline|All Participants|
661553|NCT02127567|P1|Participant Flow|All Participants|"All participants were asked to write the six parts or 'domains' of the methods section describing a randomized controlled trial. Each participant completed 3 parts or 'domains' with the tool and 3 without.~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661554|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661555|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661556|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661583|NCT02127372|E2|Reported Event|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
661629|NCT02126670|O3|Outcome|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
687591|NCT01938079|B3|Baseline|Total|Total of all reporting groups
661557|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661558|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661978|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
661559|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661560|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661561|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661562|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661563|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661564|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661565|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661566|NCT02127567|O2|Outcome|Writing With no Specific Support.|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661567|NCT02127567|O1|Outcome|Online Writing Tool|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661616|NCT02126670|B4|Baseline|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
661617|NCT02126670|B3|Baseline|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
661568|NCT02127567|O2|Outcome|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661569|NCT02127567|O1|Outcome|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661570|NCT02127567|E2|Reported Event|Writing With no Specific Support, Control Arm|"The control intervention will only consist of the title of the domain and a large text box where the participant will be asked to describe this part of the study for their study protocol. The participant will also have the option to indicate any important or necessary information that is not available in the provided study protocol.~writing with no specific support: The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols."
661571|NCT02127567|E1|Reported Event|Online Writing Tool, Experimental Arm|"Participants will be provided the corresponding CONSORT item(s), key elements from the explanation and elaboration of the CONSORT 2010 and NPT extension along with examples of good reporting~online writing tool: The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided."
661572|NCT02127372|B3|Baseline|Total|Total of all reporting groups
661573|NCT02127372|B2|Baseline|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
661574|NCT02127372|B1|Baseline|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
661575|NCT02127372|P2|Participant Flow|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
661576|NCT02127372|P1|Participant Flow|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
661577|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
661578|NCT02127372|O2|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
661579|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
661580|NCT02127372|O1|Outcome|Phase 2|The objective of this two-stage Phase II study is to determine whether the combination of STI571, docetaxel, and cisplatin merits inclusion in a randomized study for chemotherapy-naïve patients with advanced NSCLC. The dose for the Phase 2 portion of the trial will be IV Docetaxel / Cisplatin 60 / 60 mg/m2 and 400 mg STI571 PO QD
661581|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
661582|NCT02127372|O1|Outcome|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
661618|NCT02126670|B2|Baseline|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
661619|NCT02126670|B1|Baseline|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
661584|NCT02127372|E1|Reported Event|Phase 1|Eligible subjects will be enrolled in the Phase I portion of the study to determine the MTD of STI571 in combination with docetaxel plus cisplatin, given every three weeks. STI will be given intermittently for 7 days (Day -5 to Day 2) When MTD is established, Phase II study will evaluate for combined modality safety, tolerability and efficacy (response rate vs. historical control). All subjects will start with STI571 therapy alone for 7 days; pre and post STI571 treatment (Days -8 and 0)
661585|NCT02127307|B1|Baseline|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
661586|NCT02127307|P1|Participant Flow|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
661979|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
661587|NCT02127307|O1|Outcome|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
661588|NCT02127307|E1|Reported Event|AdreView™- Heart Failure Group|HF participants who were administered AdreView™ (123I-mIBG [meta-iodobenzylguanidine]) in studies MBG311 (NCT00126425) and MBG312 (NCT00126438) were observed to identify who died during 60 months of follow-up at 6-month intervals from the date of administration of 123I-mIBG.
661589|NCT02126839|B3|Baseline|Total|Total of all reporting groups
661590|NCT02126839|B2|Baseline|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
661591|NCT02126839|B1|Baseline|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
661592|NCT02126839|P2|Participant Flow|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
661593|NCT02126839|P1|Participant Flow|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
661594|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
661595|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
661596|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
661597|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
661598|NCT02126839|O2|Outcome|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
661599|NCT02126839|O1|Outcome|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
661600|NCT02126839|E2|Reported Event|Albuterol MDPI 180 mcg QID|Albuterol multidose dry powder inhaler (MDPI) 90 mcg/inhalation administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for a total daily dose of 720 mcgs for 3 weeks.
661601|NCT02126839|E1|Reported Event|Placebo MDPI QID|Placebo multidose dry powder inhaler (MDPI) administered as 2 inhalations QID (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 3 weeks.
661602|NCT02126748|B4|Baseline|Total|Total of all reporting groups
661603|NCT02126748|B3|Baseline|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
661604|NCT02126748|B2|Baseline|Assisted Autogenic Drainage|20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
661605|NCT02126748|B1|Baseline|Intrapulmonary Percussive Ventilation|20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
661606|NCT02126748|P3|Participant Flow|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
661607|NCT02126748|P2|Participant Flow|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
661608|NCT02126748|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
661609|NCT02126748|O3|Outcome|Control|20 min of bouncing administered to the patient inhalation 4ml hypertonic saline 3% 3x/day
661610|NCT02126748|O2|Outcome|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
661611|NCT02126748|O1|Outcome|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
661612|NCT02126748|E3|Reported Event|Control|20 min of bouncing administered tot the patient inhalation 4ml hypertonic saline 3% 3x/day
661613|NCT02126748|E2|Reported Event|Assisted Autogenic Drainage|"20 min of AAD administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Assisted Autogenic Drainage"
661614|NCT02126748|E1|Reported Event|Intrapulmonary Percussive Ventilation|"20 min of IPV administered to the patient inhalation 4ml hypertonic saline 3% 3x/day~inhalation 4ml hypertonic saline 3% 3x/day~Intrapulmonary Percussive Ventilation"
661615|NCT02126670|B5|Baseline|Total|Total of all reporting groups
661630|NCT02126670|O2|Outcome|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
661631|NCT02126670|O1|Outcome|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
661632|NCT02126670|E4|Reported Event|ACT01 Plus Comp04|"ACT01 Cream in combination with Comp04 Cream, once daily, 29 days~ACT01~Comp04"
661633|NCT02126670|E3|Reported Event|ACT01 Plus Comp03|"ACT01 Cream in combination with Comp03 Cream, once daily, 29 days~ACT01~Comp03"
661634|NCT02126670|E2|Reported Event|ACT01 Plus Comp02|"ACT01 Cream in combination with Comp02 Cream, once daily, 29 days~ACT01~Comp02"
661635|NCT02126670|E1|Reported Event|ACT01 Plus Comp01|"ACT01 Cream in combination with Comp01 Cream, once daily, 29 days~ACT01~Comp01"
661636|NCT02126319|B3|Baseline|Total|Total of all reporting groups
661921|NCT02123446|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
661637|NCT02126319|B2|Baseline|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661638|NCT02126319|B1|Baseline|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661639|NCT02126319|P2|Participant Flow|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661640|NCT02126319|P1|Participant Flow|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661641|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661642|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
661643|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661644|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
661645|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661646|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
661647|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661922|NCT02123446|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
661648|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
661649|NCT02126319|O2|Outcome|General Health Education|General Health Education: A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661650|NCT02126319|O1|Outcome|Cognitive Affective Preparation|"Cognitive Affective preparation: Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
661651|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661652|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661653|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661654|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661655|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661656|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661657|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661680|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661658|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661980|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
661659|NCT02126319|O2|Outcome|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661660|NCT02126319|O1|Outcome|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661661|NCT02126319|E2|Reported Event|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661662|NCT02126319|E1|Reported Event|Cognitive Affective Preparation|Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (“pre-live”) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
661663|NCT02126306|B3|Baseline|Total|Total of all reporting groups
661664|NCT02126306|B2|Baseline|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
661665|NCT02126306|B1|Baseline|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
661666|NCT02126306|P2|Participant Flow|Beta Glucosylceramide|"Beta Glucosylceramide 7.5 mg~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
661667|NCT02126306|P1|Participant Flow|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
661668|NCT02126306|O2|Outcome|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
661669|NCT02126306|O1|Outcome|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo NAS score"
661670|NCT02126306|E2|Reported Event|Beta Glucosylceramide|"Beta Glucosylceramide~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
661671|NCT02126306|E1|Reported Event|Placebo|"Placebo~Beta Glucosylceramide: Beta Glucosylceramide~placebo: placebo"
661672|NCT02125877|B3|Baseline|Total|Total of all reporting groups
661673|NCT02125877|B2|Baseline|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661674|NCT02125877|B1|Baseline|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661675|NCT02125877|P2|Participant Flow|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661676|NCT02125877|P1|Participant Flow|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661677|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661678|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661679|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661918|NCT02123459|E2|Reported Event|Cephalexin (Test)|"Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods~Cephalexin: Administered orally"
688036|NCT01937130|B2|Baseline|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
661681|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661923|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661682|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661683|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661684|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661685|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661686|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661687|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661688|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661689|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661690|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661691|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661692|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661693|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661694|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661695|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661696|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661697|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661698|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661699|NCT02125877|O2|Outcome|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661919|NCT02123459|E1|Reported Event|Cephalexin (Reference)|"Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods~Cephalexin: Administered orally"
661700|NCT02125877|O1|Outcome|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661701|NCT02125877|E2|Reported Event|Deferasirox Film-coated Tablet (DFX-FCT)|Participants received DFX-FCT 14 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 3.5 to 7 mg/kg/day, with a maximum dose of 28 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose
661702|NCT02125877|E1|Reported Event|Deferasirox Dispersible Tablet (DFX-DT)|Iron chelation naïve participants received DFX-DT 20 mg/kg/day once daily orally from weeks 1 - 4. After week 4, the dose could be adjusted by +/- 5 to 10 mg/kg/day, with a maximum dose of 40 mg/kg/day. Iron chelation pre-treated participants were supposed to start on a dose that was equivalent to their pre-washout dose.
661703|NCT02125838|B3|Baseline|Total|Total of all reporting groups
661704|NCT02125838|B2|Baseline|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661705|NCT02125838|B1|Baseline|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661706|NCT02125838|P2|Participant Flow|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661707|NCT02125838|P1|Participant Flow|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661708|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661709|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661710|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661711|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661712|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661713|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661714|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661715|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661716|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661717|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661771|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661773|NCT02125292|E2|Reported Event|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661981|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
661718|NCT02125838|O2|Outcome|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661719|NCT02125838|O1|Outcome|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661720|NCT02125838|E2|Reported Event|Group LMS|"Group LM-S (Laryngeal mask supreme Group) For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) will insert.~Laryngeal Mask Airway-Supreme: Group LM-S (laryngeal mask group)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted."
661721|NCT02125838|E1|Reported Event|Group ETT|"Group ETT (Endotracheal tube Group). In the ETT group for women no. 7-7.5 tube will use. ETT:Rüschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482~Endotracheal Tube: ETT"
661722|NCT02125734|B3|Baseline|Total|Total of all reporting groups
661723|NCT02125734|B2|Baseline|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
661724|NCT02125734|B1|Baseline|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
661725|NCT02125734|P2|Participant Flow|Treatment Sequence 2|Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
661726|NCT02125734|P1|Participant Flow|Treatment Sequence 1|QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
661727|NCT02125734|O2|Outcome|Tiotropium|
661728|NCT02125734|O1|Outcome|QVA149|
661729|NCT02125734|O2|Outcome|Tiotropium|
661730|NCT02125734|O1|Outcome|QVA149|
661731|NCT02125734|O2|Outcome|Tiotropium|
661732|NCT02125734|O1|Outcome|QVA149|
661733|NCT02125734|E2|Reported Event|Tiotropium|Tiotropium
661734|NCT02125734|E1|Reported Event|QVA149|QVA149
661735|NCT02125604|B1|Baseline|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661736|NCT02125604|P1|Participant Flow|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661737|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661738|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661739|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661740|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661741|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661742|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661743|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661744|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661745|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661746|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661747|NCT02125604|O1|Outcome|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661748|NCT02125604|E1|Reported Event|Dimethyl Fumarate|Dimethyl fumarate administered orally at 120 mg BID for the first 7 days and 240 mg BID thereafter for a total of 12 weeks.
661749|NCT02125292|B1|Baseline|All Participants|
661750|NCT02125292|P6|Participant Flow|Mesalamine in Water, Then Applesauce, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
661751|NCT02125292|P5|Participant Flow|Mesalamine in Water, Then Vanilla Yogurt, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
661772|NCT02125292|E3|Reported Event|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661752|NCT02125292|P4|Participant Flow|Mesalamine in Vanilla Yogurt, Then Water, Then Applesauce|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
661753|NCT02125292|P3|Participant Flow|Mesalamine in Applesauce, Then Vanilla Yogurt, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
661754|NCT02125292|P2|Participant Flow|Mesalamine in Applesauce, Then Water, Then Vanilla Yogurt|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
661755|NCT02125292|P1|Participant Flow|Mesalamine in Vanilla Yogurt, Then Applesauce, Then Water|Three different modes of administration were tested. Treatment A: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt and the contents were then administered to the participant; Treatment B: 1 SHP429 500mg capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce and the contents were then administered to the participant; Treatment C: 1 SHP429 500mg capsule opened and the contents emptied into a dosing cup, the contents were then administered to the participant. The participant was administered 240mL of room temperature water to aid in the consumption of the capsule content.
661756|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
661757|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
661758|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
661759|NCT02125292|O1|Outcome|All Participants|All participants who received all 3 treatments
661760|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661761|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661762|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661763|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661764|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661765|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661766|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661767|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661768|NCT02125292|O1|Outcome|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661769|NCT02125292|O3|Outcome|Mesalamine (Dosing Cup)|One 500mg Mesalamine capsule opened and the contents emptied into a dosing cup; contents were then administered to the subject with 240ml of water. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661770|NCT02125292|O2|Outcome|Mesalamine (Applesauce)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available unsweetened, creamy applesauce. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661774|NCT02125292|E1|Reported Event|Mesalamine (Vanilla Yogurt)|One 500mg Mesalamine capsule opened and the contents sprinkled onto 1 tablespoon of commercially available low-fat vanilla yogurt. All 3 treatments were administered on the same day, with a 2-hour washout period between investigational product administrations in each treatment period.
661775|NCT02124863|B1|Baseline|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
661776|NCT02124863|P1|Participant Flow|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
661777|NCT02124863|O2|Outcome|Control|mean number of refluxes during 20 min, 120 min after each meal
661778|NCT02124863|O1|Outcome|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
661779|NCT02124863|E2|Reported Event|Control|mean number of refluxes during 20 min, 120 min after each meal
661780|NCT02124863|E1|Reported Event|Intrapulmonary Percussive Ventilation|"number of refluxes during 20 min of IPV ( rate : 300/min, p = 10cmH2O) at least 120 min after feeding~Intrapulmonary Percussive Ventilation: 20 min IPV freq 300/min, p 10cmH2O"
661781|NCT02124798|B1|Baseline|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
661782|NCT02124798|P1|Participant Flow|Total|Eligible participants self administered once weekly dose of 200 milligram per milliliter (mg/mL), of belimumab subcutaneously (SC) into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
661783|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
661784|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
661785|NCT02124798|O1|Outcome|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
661786|NCT02124798|E1|Reported Event|Belimumab 200mg Auto Injector|Eligible participants self administered once weekly dose of 200 mg/mL, of belimumab SC into thigh or abdomen with an auto-injector device for 8 weeks. Of which 4 of the doses were administered under observation in the clinic (week 1, 2, 4 and week 8) under the supervision of investigator and 4 of the doses were administered outside the clinic and without observation (week 3, 5,6 and week 7).
661787|NCT02124603|B1|Baseline|Single Group|Consecutive patients scheduled for cataract surgery
661788|NCT02124603|P1|Participant Flow|Single Group|Patients undergone cataract surgery
661789|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
661790|NCT02124603|O1|Outcome|Single Group|patients undergone cataract surgery
661791|NCT02124603|O1|Outcome|Single Group|Patients undergone cataract surgery
661792|NCT02124603|E1|Reported Event|Single Group|Patients to have to undergone cataract surgery
661793|NCT02124460|B3|Baseline|Total|Total of all reporting groups
661794|NCT02124460|B2|Baseline|Health Coaching|Arm: Experimental: Health Coaching The intervention for this study will consist of three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661795|NCT02124460|B1|Baseline|Enhanced Primary Care|"Arm: No Intervention: Enhanced Primary Care We will provide current best practice to the control arm. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661796|NCT02124460|P2|Participant Flow|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.~Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.~Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
661845|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661848|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661797|NCT02124460|P1|Participant Flow|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661798|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661799|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661800|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661801|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661802|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661803|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661804|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661805|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661806|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661807|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661808|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661809|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661810|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661811|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661812|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661846|NCT02124161|O1|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
664341|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
661813|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661814|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661815|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661816|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661817|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661818|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661819|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661820|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661821|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661822|NCT02124460|O2|Outcome|Health Coaching|The intervention for this study will consist of the same best practices received by the enhanced primary care group well as the following three elements: visits with a health coach, connection to community resources and an interactive text messaging program.
661823|NCT02124460|O1|Outcome|Enhanced Primary Care|"We will provide current best practice to the control arm. Patients with a BMI greater than or equal to the 85th percentile will be flagged by in the electronic health record. Clinicians are also provided with clinical decision support tools for pediatric weight management. We will encourage providers to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661824|NCT02124460|E2|Reported Event|Health Coaching|"The intervention group will receive the same components as the enhanced primary care group for this study plus the following elements: visits with a health coach, individualized connection to community resources and an interactive text messaging program.~Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. The health coach will coach the parent/child duos on improving obesity-related behaviors and help the family identify supports to assist with behavior change and encourage use of materials related to both specific target behaviors and available resources in the community.~Parents will receive semi-weekly text messages. The messages will alternate in structure between 1) skills training messages will deliver tips to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond and track health behaviors important to this study."
661825|NCT02124460|E1|Reported Event|Enhanced Primary Care|"We will provide current best practice to the enhanced primary care arm. We will encourage providers use clinical decision support tools and to schedule a follow up visit for weight management or make a referral to Harvard Vanguard Medical Associates nutritionists for children in this arm. We will also provide this group with a community resource guide and educational text messages."
661826|NCT02124304|B3|Baseline|Total|Total of all reporting groups
661827|NCT02124304|B2|Baseline|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661847|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661828|NCT02124304|B1|Baseline|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661829|NCT02124304|P2|Participant Flow|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661830|NCT02124304|P1|Participant Flow|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661831|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661832|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661833|NCT02124304|O2|Outcome|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661834|NCT02124304|O1|Outcome|Cervical Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661835|NCT02124304|E2|Reported Event|Healthy|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661836|NCT02124304|E1|Reported Event|Cervical Neck Pain|"Thera-Band elastic and manual resistance neck exercises for neck strengthening~Neck exercises using both manual and Thera-Band elasatic resistance: Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance"
661837|NCT02124161|B3|Baseline|Total|Total of all reporting groups
661838|NCT02124161|B2|Baseline|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661839|NCT02124161|B1|Baseline|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661840|NCT02124161|P2|Participant Flow|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661841|NCT02124161|P1|Participant Flow|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661842|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661843|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661844|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661849|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661850|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661851|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661852|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661853|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661854|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661855|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661856|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661857|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661858|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661859|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661860|NCT02124161|O2|Outcome|Placebo+QIV/13vPnC|Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661861|NCT02124161|O1|Outcome|13vPnC+QIV/Placebo|Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.
661862|NCT02124161|E8|Reported Event|Placebo+QIV/13vPnC: at 6-Month Follow-up|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
661863|NCT02124161|E7|Reported Event|13vPnC+QIV/Placebo: at 6-Month Follow-up|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from blood draw 1 month blood after Vaccination 2 to 6-month follow-up.
661864|NCT02124161|E6|Reported Event|Placebo+QIV/13vPnC: After 13vPnC Vaccination|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
661865|NCT02124161|E5|Reported Event|13vPnC+QIV/Placebo: After 13vPnC Vaccination|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed after 13vPnC Vaccination.
661866|NCT02124161|E4|Reported Event|Placebo+QIV/13vPnC: After Vaccination 2|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
661916|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
661920|NCT02123446|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
661973|NCT02121860|P2|Participant Flow|Child-Pugh Class A|Mild hepatic impairment
661867|NCT02124161|E3|Reported Event|13vPnC+QIV/Placebo: After Vaccination 2|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from after Vaccination 2 up to before 1 month blood draw after Vaccination 2.
661868|NCT02124161|E2|Reported Event|Placebo+QIV/13vPnC: After Vaccination 1|All participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection (as per official recommendations) at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were accessed from Vaccination 1 up to before Vaccination 2.
661869|NCT02124161|E1|Reported Event|13vPnC+QIV/Placebo: After Vaccination 1|All participants received 0.5 mL single dose of 13vPnC vaccine intramuscularly along with a dose of QIV (as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1, were assessed from Vaccination 1 up to before Vaccination 2.
661870|NCT02124122|B3|Baseline|Total|Total of all reporting groups
661871|NCT02124122|B2|Baseline|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
661872|NCT02124122|B1|Baseline|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
661873|NCT02124122|P2|Participant Flow|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
661874|NCT02124122|P1|Participant Flow|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
661875|NCT02124122|O2|Outcome|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
661876|NCT02124122|O1|Outcome|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
661877|NCT02124122|O2|Outcome|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
661878|NCT02124122|O1|Outcome|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
661879|NCT02124122|E2|Reported Event|Placebo|"Placebo oil preparation, administered as 5 drops of the oil vehicle used in manufacturing the Lr suspension, given once daily for a five-day study period (BioGaia AB, Stockholm, Sweden).~Placebo: Placebo"
661880|NCT02124122|E1|Reported Event|Lactobacillus|"Lactobacillus reuteri (Lr): 108 (100 million) organisms of Lactobacillus reuteri per dose, given once daily for a five-day treatment period that corresponds to a dose of the closely related L. reuteri ATCC 55730 strain that has shown to be therapeutic for infantile colic. The strain used in this study (DSM 17938) has been cured of an antibiotic resistance plasmid found in the original BioGaia strain (L. reuteri ATCC 55730).~Lactobacillus reuteri: Probiotic"
661881|NCT02124044|B3|Baseline|Total|Total of all reporting groups
661882|NCT02124044|B2|Baseline|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
661883|NCT02124044|B1|Baseline|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
661884|NCT02124044|P2|Participant Flow|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
661885|NCT02124044|P1|Participant Flow|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
661886|NCT02124044|O2|Outcome|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
661887|NCT02124044|O1|Outcome|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
661888|NCT02124044|E2|Reported Event|HIV/HCV GT-1b, 24 Wks ASV/DCV|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
661889|NCT02124044|E1|Reported Event|HIV/HCV GT-1a/1b, 12 Wks ASV/DCV With BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
661917|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
661890|NCT02123745|B1|Baseline|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661891|NCT02123745|P1|Participant Flow|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661892|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661893|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661894|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661895|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661896|NCT02123745|O1|Outcome|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661897|NCT02123745|E1|Reported Event|Infiltrated Tissue|"The ivWatch Model 400 monitored an IV site during the infiltration of 10 mL of isotonic saline solution. IV sites were placed in the forearm and the dorsal aspect of the hand. The rate of the infiltration ranged between 5 mL/hr to 150 mL/hr.~The ivWatch Model 400: The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected."
661898|NCT02123472|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion)
661899|NCT02123472|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
661900|NCT02123472|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
661901|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661902|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661903|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661904|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661905|NCT02123472|O2|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661906|NCT02123472|O1|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661907|NCT02123472|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661908|NCT02123472|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661909|NCT02123459|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
661910|NCT02123459|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
661911|NCT02123459|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
661912|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
661913|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
661914|NCT02123459|O2|Outcome|Cephalexin (Test)|Cephalexin (Treatment B) manufactured in Brasil by Antibioticos do Brasil Ltda administered once orally in one of two study periods
661915|NCT02123459|O1|Outcome|Cephalexin (Reference)|Cephalexin (Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods
661924|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661925|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661926|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661927|NCT02123446|O2|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661928|NCT02123446|O1|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661929|NCT02123446|E2|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
661930|NCT02123446|E1|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
661931|NCT02123017|B4|Baseline|Total|Total of all reporting groups
661932|NCT02123017|B3|Baseline|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
661933|NCT02123017|B2|Baseline|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
661934|NCT02123017|B1|Baseline|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
661935|NCT02123017|P3|Participant Flow|180 Grams Crystalline Lactulose|15 mg bisacodyl, plus 60 grams crystalline lactulose x 3 doses
661936|NCT02123017|P2|Participant Flow|135 Grams Crystalline Lactulose|15 mg bisacodyl, plus 45 grams crystalline lactulose x 3 doses
661937|NCT02123017|P1|Participant Flow|90 Grams Crystalline Lactulose|15 mg bisacodyl, plus 30 grams crystalline lactulose x 3 doses
661938|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
661939|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
661940|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
661941|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
661942|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
661943|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
661944|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
661945|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
661946|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
661947|NCT02123017|O3|Outcome|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
661948|NCT02123017|O2|Outcome|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
661949|NCT02123017|O1|Outcome|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
661950|NCT02123017|E3|Reported Event|180 Grams of Crystalline Lactulose|15 mg of bisacodyl and 60 grams crystalline lactulose x 3 doses
661951|NCT02123017|E2|Reported Event|135 Grams of Crystalline Lactulose|15 mg of bisacodyl and 45 grams crystalline lactulose x 3 doses
661952|NCT02123017|E1|Reported Event|90 Grams of Crystalline Lactulose|15 mg of bisacodyl and 30 grams crystalline lactulose x 3 doses
661953|NCT02122549|B1|Baseline|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
661954|NCT02122549|P1|Participant Flow|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
661955|NCT02122549|O1|Outcome|HWD1000|Subjects wearing the HWD 1000.
661956|NCT02122549|E1|Reported Event|HWD1000|"Subjects using HWD1000~HWD1000: Wearable cardioverter-defibrillator designed for inpatient use"
661957|NCT02122445|B1|Baseline|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
661958|NCT02122445|P1|Participant Flow|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
661959|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
661960|NCT02122445|O1|Outcome|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
661961|NCT02122445|E1|Reported Event|Low Back Pain|"Lower body exercises before and after the application of Cramer Sports Motion tape~Cramer Sports Motion Tape: lower body exercises with and without Cramer Sports Motion tape applied to the hip"
661962|NCT02122406|B1|Baseline|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
661963|NCT02122406|P1|Participant Flow|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
661964|NCT02122406|O1|Outcome|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
661965|NCT02122406|E1|Reported Event|Patients RA-BIO|Patients with rheumatoid arthritis treated with biological drugs
661966|NCT02121860|B5|Baseline|Total|Total of all reporting groups
661967|NCT02121860|B4|Baseline|Normal Hepatic Function|Medically healthy as determined by the investigator
661968|NCT02121860|B3|Baseline|Child-Pugh Class C|Severe Hepatic Impairment
661969|NCT02121860|B2|Baseline|Child-Pugh Class B|Moderate Hepatic Impairment
661970|NCT02121860|B1|Baseline|Child-Pugh Class A|Mild Hepatic Impairment
661971|NCT02121860|P4|Participant Flow|Child-Pugh Class C|Severe hepatic impairment
661972|NCT02121860|P3|Participant Flow|Child-Pugh Class B|Moderate hepatic impairment
661982|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
661983|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
661984|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
661985|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
661986|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
661987|NCT02121860|O4|Outcome|Child-Pugh Class C|Severe Hepatic Impairment
661988|NCT02121860|O3|Outcome|Child-Pugh Class B|Moderate Hepatic Impairment
661989|NCT02121860|O2|Outcome|Child-Pugh Class A|Mild Hepatic Impairment
661990|NCT02121860|O1|Outcome|Normal Hepatic Function|Medically healthy as determined by the investigator
661991|NCT02121860|E1|Reported Event|IDN-6556|Single 50 mg oral dose of IDN-6556
661992|NCT02121847|B1|Baseline|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
661993|NCT02121847|P1|Participant Flow|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
661994|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
661995|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
661996|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
661997|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
661998|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
661999|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662000|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662001|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662002|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662003|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662004|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662005|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662006|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662007|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662008|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662009|NCT02121847|O1|Outcome|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662010|NCT02121847|E1|Reported Event|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily and carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
662011|NCT02121795|B3|Baseline|Total|Total of all reporting groups
662012|NCT02121795|B2|Baseline|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662013|NCT02121795|B1|Baseline|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
662014|NCT02121795|P2|Participant Flow|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662015|NCT02121795|P1|Participant Flow|F/TAF + 3rd Agent|Emtricitabine/tenofovir alafenamide (F/TAF) (200/25 mg or 200/10 mg) tablet + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo tablet + third agent administered orally once daily for at least 96 weeks
662121|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662016|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662017|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
662018|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662019|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
662020|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662021|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
662022|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662023|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
662024|NCT02121795|O2|Outcome|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662025|NCT02121795|O1|Outcome|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
662026|NCT02121795|E2|Reported Event|FTC/TDF + 3rd Agent|FTC/TDF 200/300 mg tablet + F/TAF placebo tablet + third agent administered orally once daily for at least 96 weeks
662027|NCT02121795|E1|Reported Event|F/TAF + 3rd Agent|F/TAF (200/25 mg or 200/10 mg) tablet + FTC/TDF placebo tablet + third agent administered orally once daily for at least 96 weeks
662028|NCT02121535|B3|Baseline|Total|Total of all reporting groups
662029|NCT02121535|B2|Baseline|Sequence RTTR|Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4). T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period.
662030|NCT02121535|B1|Baseline|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).~T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.~The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
662031|NCT02121535|P2|Participant Flow|Sequence RTTR|"Oral administration of study drugs in the following order: R (period 1) - T (period 2) - T (period 3) - R (period 4).~T: telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily. The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
662032|NCT02121535|P1|Participant Flow|Sequence TRRT|"Oral administration of study drugs in the following order: T (period 1) - R(period 2) - R (period 3) - T (period 4).~T: telmisartan 80mg+amlodipine 5mg+ hydrochlorothiazide (HCTZ) 12.5mg fix dose tab, once daily; R: telmisartan 80mg+amlodipine 5mg fixed dose combination (FDC) + HCTZ 12.5mg tablet , once daily.~The washout period between drug administrations had to be at least 14 days from the study drug administration of the previous period."
662033|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662034|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662035|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662036|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662037|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662038|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662039|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662040|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662041|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662042|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662043|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662044|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662045|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662046|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662047|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662048|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662049|NCT02121535|O2|Outcome|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
662050|NCT02121535|O1|Outcome|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662051|NCT02121535|E3|Reported Event|Total (All Patients)|Total of all the participants analyzed
662052|NCT02121535|E2|Reported Event|Reference Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg FDC + HCTZ 12.5mg tablet , once daily.
703005|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
662053|NCT02121535|E1|Reported Event|Test Treatment|Oral administration of telmisartan 80mg+amlodipine 5mg+HCTZ 12.5mg fixed dose combination (FDC), once daily;
662054|NCT02121522|B1|Baseline|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
662055|NCT02121522|P1|Participant Flow|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
662056|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
662057|NCT02121522|O1|Outcome|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
662058|NCT02121522|E1|Reported Event|BI 144807|Subjects were orally administered with 400 mg film coated tables twice daily (two tablets of 200 mg twice daily)
662059|NCT02121509|B3|Baseline|Total|Total of all reporting groups
662060|NCT02121509|B2|Baseline|FDC 1500 Fed or L+M 1500 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1500 fed (T fed): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1500 fed (R fed): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
662061|NCT02121509|B1|Baseline|FDC 1500 Fasted or L+M 1500 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1500 fasted (T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1500 fasted (R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
662062|NCT02121509|P4|Participant Flow|L+M 1500 Fed / FDC 1500 Fed|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
662063|NCT02121509|P3|Participant Flow|FDC 1500 Fed / L+M 1500 Fed|"Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
662064|NCT02121509|P2|Participant Flow|L+M 1500 Fasted / FDC 1500 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin XR (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
662065|NCT02121509|P1|Participant Flow|FDC 1500 Fasted / L+M 1500 Fasted|"Linagliptin+ Metformin extended release (XR) (FDC)-(T fasted): 5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) followed by Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 1500mg"
662066|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
662067|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
662068|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
662069|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
662070|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
662071|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
662072|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
662073|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
662074|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
662075|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
662076|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
662077|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
662078|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
662079|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
662122|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662080|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
662081|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
662082|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
662083|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
662084|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
662085|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
662086|NCT02121509|O4|Outcome|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
662087|NCT02121509|O3|Outcome|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
662088|NCT02121509|O2|Outcome|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
662089|NCT02121509|O1|Outcome|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
662090|NCT02121509|E4|Reported Event|FDC 1500 Fed|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after a high-fat, high-calorie meal.
662091|NCT02121509|E3|Reported Event|L+M 1500 Fed|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
662092|NCT02121509|E2|Reported Event|FDC 1500 Fasted|5 mg linagliptin/1500 mg metformin XR (given as 2*2.5mg linagliptin/750mg metformin XR FDC tablets) orally with 240 mL of water after an overnight fast of at least 10 h.
662093|NCT02121509|E1|Reported Event|L+M 1500 Fasted|5 mg linagliptin and 1500 mg metformin XR (given as 1 tablet 5 mg linagliptin and 3 tablets 500 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
662094|NCT02121483|B4|Baseline|Total|Total of all reporting groups
662095|NCT02121483|B3|Baseline|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662096|NCT02121483|B2|Baseline|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662097|NCT02121483|B1|Baseline|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662098|NCT02121483|P3|Participant Flow|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662099|NCT02121483|P2|Participant Flow|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662100|NCT02121483|P1|Participant Flow|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662101|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662102|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662103|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662104|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662105|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662106|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662107|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662108|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662109|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662110|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
664342|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
662111|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662112|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662113|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662114|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662115|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662116|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662117|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662118|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662119|NCT02121483|O3|Outcome|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662120|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
664353|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
662123|NCT02121483|O2|Outcome|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662124|NCT02121483|O1|Outcome|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662125|NCT02121483|E3|Reported Event|Empagliflozin 25mg|Single dose (1 tablet) of 25mg, empagliflozin, film-coated tablet administered orally.
662126|NCT02121483|E2|Reported Event|Empagliflozin 10mg|Single dose (1 tablet) of 10mg, empagliflozin, film-coated tablet administered orally.
662127|NCT02121483|E1|Reported Event|Empagliflozin 5mg|Single dose (1 tablet) of 5mg, empagliflozin, film-coated tablet administered orally.
662128|NCT02121067|B1|Baseline|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
662129|NCT02121067|P1|Participant Flow|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
662130|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
662131|NCT02121067|O1|Outcome|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled"
662132|NCT02121067|O1|Outcome|Percentage of Participants Who Would Recommend the LNG-IUS|Of the participants who were reached at 6 months postpartum, this is the number that would recommend LNG-IUS insertion during the 2nd postpartum week.
662133|NCT02121067|E1|Reported Event|LNG-IUS Placed at 2 Weeks Postpartum|"Enrolled women will have the LNG-IUS placed at two-weeks (14-20 days) postpartum~Levonorgestrel Intrauterine System (LNG-IUS): The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled."
662134|NCT02121041|B3|Baseline|Total|Total of all reporting groups
662135|NCT02121041|B2|Baseline|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
662136|NCT02121041|B1|Baseline|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
662137|NCT02121041|P2|Participant Flow|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
662138|NCT02121041|P1|Participant Flow|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
662139|NCT02121041|O2|Outcome|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
662140|NCT02121041|O1|Outcome|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
662141|NCT02121041|E2|Reported Event|ABPM Guided|"Participants in the ABPM-guided arm will undergo 3 ABPM sessions. Results of ABPM will be used to make diagnoses and dictate anti-hypertensive treatment as applicable. Anti-hypertensive medications may include: Amlodipine, Chlorthalidone and/or Losartan.~Amlodipine: Amlodipine 5 mg or 10 mg~Chlorthalidone: Chlorthalidone 12.5 mg or 25 mg~Losartan: Losartan 50 mg or 100 mg"
662142|NCT02121041|E1|Reported Event|Usual Care|Participants in the usual care arm will have 2 ABPM sessions during the study, but ABPM will not be used to make a diagnosis or dictate anti-hypertensive treatment. Any recommendations for anti-hypertensive treatment will be made only via regular clinical care.
662143|NCT02120833|B3|Baseline|Total|Total of all reporting groups
662144|NCT02120833|B2|Baseline|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662145|NCT02120833|B1|Baseline|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662146|NCT02120833|P2|Participant Flow|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662147|NCT02120833|P1|Participant Flow|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662148|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662149|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662150|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662151|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662152|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662153|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662154|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662155|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662156|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662157|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662158|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662159|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662160|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662161|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662162|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662163|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662164|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662165|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662166|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662167|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662168|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662169|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662170|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662171|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662172|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662173|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662174|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662175|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662176|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662177|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662178|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662179|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662180|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662181|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662182|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662183|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662184|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662185|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662186|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662187|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662188|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662189|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662190|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662191|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662192|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662193|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662194|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662195|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662196|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662197|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662198|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662199|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662200|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662201|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662202|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662203|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662204|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662205|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662206|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662207|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662208|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662209|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662210|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662211|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662212|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662213|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662214|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662215|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662216|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662217|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662218|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662219|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662220|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662221|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662222|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662223|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662224|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662225|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662226|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662227|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662228|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662229|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662230|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662231|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662232|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662233|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662234|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662235|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662236|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662237|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662238|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662239|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662240|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662241|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662242|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662243|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662244|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662245|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662246|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662247|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662248|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662249|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662250|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662251|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662252|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662253|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662254|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662255|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662256|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662257|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662258|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662259|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662260|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662261|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662262|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662263|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662264|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662265|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662266|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662267|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662268|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662269|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662270|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662271|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662272|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662273|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662274|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662275|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662276|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662277|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662278|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662279|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662280|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662281|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662282|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662283|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662284|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662285|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662286|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662287|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662288|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662289|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662290|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662291|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662292|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662293|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662294|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662295|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662296|NCT02120833|O2|Outcome|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662297|NCT02120833|O1|Outcome|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662298|NCT02120833|E2|Reported Event|EpiCeram® Skin Barrier Emulsion|EpiCeram® Skin Barrier Emulsion, thin layer twice a day
662299|NCT02120833|E1|Reported Event|1% Colloidal Oatmeal Eczema Cream|1% Colloidal Oatmeal Eczema Cream, thin layer twice a day
662300|NCT02120664|B6|Baseline|Total|Total of all reporting groups
662301|NCT02120664|B5|Baseline|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
662302|NCT02120664|B4|Baseline|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
662303|NCT02120664|B3|Baseline|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
662304|NCT02120664|B2|Baseline|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
662305|NCT02120664|B1|Baseline|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
662306|NCT02120664|P5|Participant Flow|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
662307|NCT02120664|P4|Participant Flow|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
662308|NCT02120664|P3|Participant Flow|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
662309|NCT02120664|P2|Participant Flow|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
662310|NCT02120664|P1|Participant Flow|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
662311|NCT02120664|O2|Outcome|Florbetapir SUVR Variability|Variability of standardized uptake value ratio (SUVR) for florbetapir scans in young healthy controls
662312|NCT02120664|O1|Outcome|PiB SUVR Variability|Variability of standardized uptake value ratio (SUVR) for PiB scans in young healthy controls
662313|NCT02120664|O5|Outcome|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
662314|NCT02120664|O4|Outcome|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
662315|NCT02120664|O3|Outcome|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
662316|NCT02120664|O2|Outcome|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
662317|NCT02120664|O1|Outcome|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
662318|NCT02120664|O5|Outcome|Young Healthy Controls (YHC)|Cognitively normal young subjects between 21 and 45 years of age (inclusive)
662319|NCT02120664|O4|Outcome|At Risk Elderly|Elderly patients, 75 years or older, who are known ApoE4 gene carriers, and cognitively normal
662320|NCT02120664|O3|Outcome|Mild Cognitive Impairment (MCI)|Patients with a clinical diagnosis of Mild Cognitive Impairment (MCI) and not dementia. Age is 60 years or greater
662321|NCT02120664|O2|Outcome|Possible AD|Patients meeting clinical criteria for dementia due to possible Alzheimer's Disease
662322|NCT02120664|O1|Outcome|Clincally Diagnosed AD|Patients meeting clinical criteria for dementia due to probable Alzheimer's Disease (AD)
662323|NCT02120664|E4|Reported Event|Total|Events following Florbetapir (florbetapir only and both)
662324|NCT02120664|E3|Reported Event|Both|Events occurring within 48 hours of both florbetapir and PiB scans
662325|NCT02120664|E2|Reported Event|PiB Only|Events occurring within 48 hours of PiB scans only
662326|NCT02120664|E1|Reported Event|Florbetapir Only|Events occurring within 48 hours following florbetapir scans only
662327|NCT02120625|B1|Baseline|Baseline Demographics|
662328|NCT02120625|P1|Participant Flow|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
662329|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
662330|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
662331|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
662332|NCT02120625|O1|Outcome|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
662333|NCT02120625|E1|Reported Event|Lumbar MB RFN|Patients undergoing lumbar medial branch radiofrequency ablation using the Nimbus MEE Probe who undergo MRI and EMG validation testing of efficacy of intended lesion production.
662334|NCT02120443|B1|Baseline|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
662335|NCT02120443|P1|Participant Flow|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
662336|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
662337|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
662338|NCT02120443|O1|Outcome|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
662339|NCT02120443|E1|Reported Event|Non-Infiltrated Tissue|"The ivWatch Model 400 monitored a common peripheral IV site over a 24 hour observation period.~ivWatch Model 400: The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period."
662340|NCT02120300|B5|Baseline|Total|Total of all reporting groups
662341|NCT02120300|B4|Baseline|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662342|NCT02120300|B3|Baseline|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662343|NCT02120300|B2|Baseline|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662344|NCT02120300|B1|Baseline|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662345|NCT02120300|P4|Participant Flow|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662346|NCT02120300|P3|Participant Flow|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662347|NCT02120300|P2|Participant Flow|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662348|NCT02120300|P1|Participant Flow|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662349|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662350|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662351|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662352|NCT02120300|O3|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662353|NCT02120300|O2|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662354|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662355|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662356|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662357|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662358|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662359|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662360|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662361|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662362|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662363|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662364|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662365|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662366|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662367|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662368|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662369|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662370|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662371|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662372|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662373|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662374|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662375|NCT02120300|O4|Outcome|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662376|NCT02120300|O3|Outcome|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662377|NCT02120300|O2|Outcome|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662378|NCT02120300|O1|Outcome|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662379|NCT02120300|E4|Reported Event|SOF+RBV 24 Weeks GT3|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks (genotype 3)
662380|NCT02120300|E3|Reported Event|SOF+RBV 12 Weeks GT2|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 2)
662381|NCT02120300|E2|Reported Event|LDV/SOF 24 Weeks GT1 (TE)|LDV/SOF (90/400 mg) FDC tablet once daily for 24 weeks (treatment-experienced [TE] participants with genotype 1 HCV infection and cirrhosis)
662382|NCT02120300|E1|Reported Event|LDV/SOF 12 Weeks GT1 or GT4|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for 12 weeks (genotype 1 or 4)
662383|NCT02120027|B3|Baseline|Total|Total of all reporting groups
662384|NCT02120027|B2|Baseline|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
662412|NCT02119676|B4|Baseline|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662385|NCT02120027|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
662386|NCT02120027|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily."
662387|NCT02120027|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
662388|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
662389|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
704925|NCT01825122|O2|Outcome|Active, Nadolol|"Active~Nadolol"
662390|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
662391|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
662392|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
662393|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
662394|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
662395|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
662396|NCT02120027|O2|Outcome|Placebo|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the placebo arm will be re-randomised at week 25 in a 1:1 ratio to ibodutant or placebo for additional 28 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
662397|NCT02120027|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 24 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will continue on ibodutant 10 mg for additional 28 weeks of treatment via mock-re-randomisation at week 25 .~Ibodutant 10 mg: Oral tablet, to be given once daily."
662398|NCT02120027|E2|Reported Event|Placebo for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
662399|NCT02120027|E1|Reported Event|Ibodutant 10 mg for 24-week Treatment|"Oral tablet to be given once daily for 24 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
662400|NCT02120001|B3|Baseline|Total|Total of all reporting groups
662401|NCT02120001|B2|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
662402|NCT02120001|B1|Baseline|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
662403|NCT02120001|P2|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
662404|NCT02120001|P1|Participant Flow|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
662405|NCT02120001|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
662406|NCT02120001|O1|Outcome|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
662407|NCT02120001|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
662408|NCT02120001|O1|Outcome|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
662409|NCT02120001|E2|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
662410|NCT02120001|E1|Reported Event|ETT Cleaning Maneuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
662411|NCT02119676|B5|Baseline|Total|Total of all reporting groups
662413|NCT02119676|B3|Baseline|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662414|NCT02119676|B2|Baseline|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662415|NCT02119676|B1|Baseline|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662416|NCT02119676|P4|Participant Flow|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662417|NCT02119676|P3|Participant Flow|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662418|NCT02119676|P2|Participant Flow|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662419|NCT02119676|P1|Participant Flow|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg twice a day (BID) continuous with regorafenib 160 mg once daily (QD) for the first 21 days of each 28-day cycle.
662420|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662421|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662422|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662423|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662424|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662425|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662426|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662427|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662428|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662429|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662430|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662431|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662432|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662433|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662434|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662435|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662436|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662437|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662438|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662439|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662440|NCT02119676|O4|Outcome|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662441|NCT02119676|O3|Outcome|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662442|NCT02119676|O2|Outcome|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662443|NCT02119676|O1|Outcome|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662444|NCT02119676|E4|Reported Event|Substudy 2: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662445|NCT02119676|E3|Reported Event|Substudy 2: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662446|NCT02119676|E2|Reported Event|Substudy 1: Placebo + Regorafenib|Placebo BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662447|NCT02119676|E1|Reported Event|Substudy 1: Ruxolitinib + Regorafenib|Ruxolitinib 15 mg BID continuous with regorafenib 160 mg QD for the first 21 days of each 28-day cycle.
662448|NCT02119663|B3|Baseline|Total|Total of all reporting groups
662449|NCT02119663|B2|Baseline|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662450|NCT02119663|B1|Baseline|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662451|NCT02119663|P2|Participant Flow|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662452|NCT02119663|P1|Participant Flow|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662559|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662453|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662454|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662455|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662456|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662457|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662458|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662459|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662460|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662461|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662462|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662463|NCT02119663|O2|Outcome|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662464|NCT02119663|O1|Outcome|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662465|NCT02119663|E2|Reported Event|Placebo Plus Capecitabine|Placebo 5 mg matching placebo tablets in combination with Capecitabine: 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662466|NCT02119663|E1|Reported Event|Ruxolitinib Plus Capecitabine|Ruxolitinib 5 mg tablets in combination with Capecitabine 150 mg or 500 mg tablets to be administered by mouth twice daily (BID).
662467|NCT02119650|B3|Baseline|Total|Total of all reporting groups
662468|NCT02119650|B2|Baseline|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662469|NCT02119650|B1|Baseline|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662470|NCT02119650|P2|Participant Flow|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662471|NCT02119650|P1|Participant Flow|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg twice daily (BID) oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662472|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662473|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662474|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662475|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662476|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662555|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662477|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662478|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662479|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662508|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
704926|NCT01825122|O1|Outcome|Placebo|"placebo~Placebo"
662480|NCT02119650|O2|Outcome|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662481|NCT02119650|O1|Outcome|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662482|NCT02119650|E2|Reported Event|Double-Blind Treatment: Placebo Plus Pemetrexed/Cisplatin|Matching placebo was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662483|NCT02119650|E1|Reported Event|Double-Blind Treatment: Ruxolitinib + Pemetrexed/Cisplatin|Ruxolitinib was self-administered as a 15 mg BID oral treatment during the randomized, double-blind treatment, without regard to food. Pemetrexed 500 mg/m^2 was administered as an intravenous infusion over 10 minutes, and 75 mg/m^2 Cisplatin was infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion on Day 1 of each 21-day cycle (Treatment Cycles).
662484|NCT02119325|B1|Baseline|Overall Participants|
662485|NCT02119325|P2|Participant Flow|Sequence 2|Participants were administered with Placebo followed by Test. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662486|NCT02119325|P1|Participant Flow|Sequence 1|Participants were adminisetered with Test followed by Placebo. Test comprised of a fibre rich health food drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin). Placebo was a 'No fibre' health food drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662487|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662488|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662489|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662490|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662491|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662492|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662493|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662494|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662495|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662496|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662497|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662498|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662499|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662500|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662501|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662556|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662502|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662503|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662504|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662505|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662506|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662507|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662509|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662510|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662511|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662512|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662513|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662514|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662515|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water
662516|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662517|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662518|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662519|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662520|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662521|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662522|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662523|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662524|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662525|NCT02119325|O2|Outcome|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662526|NCT02119325|O1|Outcome|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibe (resistant maltodextrin).
662527|NCT02119325|E2|Reported Event|Placebo|No Fibre Health Food Drink packed as 25g individual sachet, administered as single serve in 200 mL of luke warm water.
662528|NCT02119325|E1|Reported Event|Test|Fibre rich Health Food Drink packed as 30g individual sachet, administered as a single serve in 200 mL of luke warm water. The active constituent consisted of 25% fibre (resistant maltodextrin).
662529|NCT02119286|B4|Baseline|Total|Total of all reporting groups
662530|NCT02119286|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662531|NCT02119286|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662532|NCT02119286|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662557|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662558|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662533|NCT02119286|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662534|NCT02119286|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662535|NCT02119286|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
664354|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
662536|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662537|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662538|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662539|NCT02119286|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662540|NCT02119286|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662541|NCT02119286|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662542|NCT02119286|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662543|NCT02119286|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662544|NCT02119286|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
662545|NCT02118961|B3|Baseline|Total|Total of all reporting groups
662546|NCT02118961|B2|Baseline|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662547|NCT02118961|B1|Baseline|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662548|NCT02118961|P2|Participant Flow|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662549|NCT02118961|P1|Participant Flow|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662550|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662551|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662552|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662553|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662554|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
688037|NCT01937130|B1|Baseline|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
662560|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662561|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662562|NCT02118961|O2|Outcome|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662563|NCT02118961|O1|Outcome|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662564|NCT02118961|E2|Reported Event|DT Toxoid|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid): 0.1 mL, subcutaneous injection
662565|NCT02118961|E1|Reported Event|BK1301|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301): 0.5 mL, subcutaneous injection
662566|NCT02118896|B11|Baseline|Total|Total of all reporting groups
662567|NCT02118896|B10|Baseline|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662568|NCT02118896|B9|Baseline|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662569|NCT02118896|B8|Baseline|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662570|NCT02118896|B7|Baseline|PMR-EC-1105|"Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.~Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to"
662571|NCT02118896|B6|Baseline|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662572|NCT02118896|B5|Baseline|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662573|NCT02118896|B4|Baseline|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662574|NCT02118896|B3|Baseline|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662575|NCT02118896|B2|Baseline|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662576|NCT02118896|B1|Baseline|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662577|NCT02118896|P10|Participant Flow|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662578|NCT02118896|P9|Participant Flow|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662579|NCT02118896|P8|Participant Flow|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662580|NCT02118896|P7|Participant Flow|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662581|NCT02118896|P6|Participant Flow|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662582|NCT02118896|P5|Participant Flow|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662583|NCT02118896|P4|Participant Flow|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662584|NCT02118896|P3|Participant Flow|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662585|NCT02118896|P2|Participant Flow|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662586|NCT02118896|P1|Participant Flow|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662587|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662588|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662589|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662590|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662591|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662592|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662593|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662594|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662595|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662596|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662597|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662598|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662599|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662600|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662601|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662602|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662603|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662604|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662605|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662606|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662607|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662608|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662609|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662610|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662611|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662612|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662613|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662614|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662615|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662616|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662617|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study. There were no reported BCAR in subjects in the previous study PMR-EC-1210, Kaplan-Meier estimate not applicable.
662618|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662619|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662620|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662621|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662622|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662623|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662624|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662625|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662626|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662627|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662628|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662629|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662630|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662631|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662632|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662633|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662634|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662635|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662636|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662637|NCT02118896|O10|Outcome|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662638|NCT02118896|O9|Outcome|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
688038|NCT01937130|P4|Participant Flow|Placebo|"Dosed twice daily~Placebo"
662639|NCT02118896|O8|Outcome|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662640|NCT02118896|O7|Outcome|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662641|NCT02118896|O6|Outcome|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662642|NCT02118896|O5|Outcome|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662643|NCT02118896|O4|Outcome|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662644|NCT02118896|O3|Outcome|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662645|NCT02118896|O2|Outcome|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
664355|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
662646|NCT02118896|O1|Outcome|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662647|NCT02118896|E10|Reported Event|PMR-EC-1210|Participants that had previously taken part in the PMR-EC-1210 Phase III de novo kidney transplant recipient study.
662648|NCT02118896|E9|Reported Event|PMR-EC-1209|Participants that had previously taken part in the PMR-EC-1209 Phase III kidney transplant recipient (Conversion from cyclosporine A to MR4) study.
662649|NCT02118896|E8|Reported Event|PMR-EC-1205|Participants that had previously taken part in the PMR-EC-1205 Phase III kidney transplant recipient (Conversion from Prograf® to MR4) study.
662650|NCT02118896|E7|Reported Event|PMR-EC-1105|Participants that had previously taken part in the PMR-EC-1105 Phase III liver transplant recipient (Conversion from Prograf® to MR4) study.
662651|NCT02118896|E6|Reported Event|FG-506E-12-03|Participants that had previously taken part in the FG-506E-12-03 Phase III de novo kidney transplant recipient study.
662652|NCT02118896|E5|Reported Event|FG-506E-11-03|Participants that had previously taken part in the FG-506E-11-03 Phase III de novo liver transplant recipient study.
662653|NCT02118896|E4|Reported Event|FG-506-15-02|Participants that had previously taken part in the FG-506-15-02 Phase II heart transplant recipient (Conversion from Prograf® to MR4) study.
662654|NCT02118896|E3|Reported Event|FG-506E-12-02|Participants that had previously taken part in the FG-506E-12-02 Phase II kidney transplant recipient (Conversion from Prograf® to MR4) study.
662655|NCT02118896|E2|Reported Event|FG-506E-12-01|Participants that had previously taken part in the FG-506E-12-01 Phase II de novo kidney transplant recipient study.
662656|NCT02118896|E1|Reported Event|FG-506-11-01|Participants that had previously taken part in the FG-506-11-01 Phase II de novo liver transplant recipient study.
662657|NCT02118831|B4|Baseline|Total|Total of all reporting groups
662658|NCT02118831|B3|Baseline|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
662659|NCT02118831|B2|Baseline|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
662660|NCT02118831|B1|Baseline|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
662661|NCT02118831|P3|Participant Flow|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
662662|NCT02118831|P2|Participant Flow|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
662663|NCT02118831|P1|Participant Flow|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
662664|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
662665|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
662666|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
662667|NCT02118831|O3|Outcome|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
662668|NCT02118831|O2|Outcome|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
662669|NCT02118831|O1|Outcome|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
662670|NCT02118831|E3|Reported Event|Ranibizumab|"Blood samples will be collected from patients receiving ranibizumab following the first and third dose of standard care therapy.~Ranibizumab: Subjects will receive intravitreal ranibizumab injections as part of their routine medical care."
662671|NCT02118831|E2|Reported Event|Bevacizumab|"Blood samples will be collected from patients receiving bevacizumab following the first and third dose of standard care therapy.~Bevacizumab: Subjects will receive intravitreal bevacizumab as part of their routine medical care."
662672|NCT02118831|E1|Reported Event|Aflibercept|"Blood samples will be collected from patients receiving aflibercept following the first and third dose of standard care therapy.~Aflibercept: Subjects will receive intravitreal aflibercept as part of their routine medical care."
662673|NCT02118792|B3|Baseline|Total|Total of all reporting groups
662674|NCT02118792|B2|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662675|NCT02118792|B1|Baseline|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662676|NCT02118792|P2|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662677|NCT02118792|P1|Participant Flow|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable atopic dermatitis (AD)-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662678|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662679|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662680|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662681|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662682|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662683|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662684|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662685|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662686|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662687|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662688|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662689|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662690|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662691|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662692|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662693|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662694|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662695|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662696|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662697|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662698|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662699|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662700|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662701|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662702|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662703|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662704|NCT02118792|O2|Outcome|AN2728 Topical Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662705|NCT02118792|O1|Outcome|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662706|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662707|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662708|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662709|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662710|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662711|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662712|NCT02118792|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment, vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662713|NCT02118792|O1|Outcome|AN2728 Ointment, 2 Percent (%)|AN2728 ointment, 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662714|NCT02118792|E2|Reported Event|AN2728 Topical Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662715|NCT02118792|E1|Reported Event|AN2728 Topical Ointment, 2 Percent (%)|AN2728 ointment 2% was applied topically twice daily, to all treatable AD-involved areas (excluding scalp), from Day 1 up to Day 28 in each participant. Treatable AD-involved areas were identified at Baseline (Day 1) by investigator.
662716|NCT02118766|B3|Baseline|Total|Total of all reporting groups
662717|NCT02118766|B2|Baseline|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662718|NCT02118766|B1|Baseline|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662719|NCT02118766|P2|Participant Flow|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662720|NCT02118766|P1|Participant Flow|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662721|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
664343|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
662722|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662723|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662724|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662725|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
704927|NCT01825122|E2|Reported Event|Active, Nadolol|"Active~Nadolol"
662726|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662727|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662728|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662729|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662730|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662731|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662732|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662733|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662734|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662735|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662736|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662737|NCT02118766|O2|Outcome|AN2728 Topical Ointment, Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662738|NCT02118766|O1|Outcome|AN2728 Topical Ointment, 2 Percent|Participants with mild to moderate atopic dermatitis (AD) applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662739|NCT02118766|E2|Reported Event|Crisaborole (AN2728) Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment matching vehicle to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662740|NCT02118766|E1|Reported Event|Crisaborole (AN2728) Ointment, 2 Percent|Participants with mild to moderate AD applied AN2728 ointment, 2 percent to treatment-targeted lesions, twice daily from Day 1 to Day 28. Target lesions were identified at Baseline (Day 1) by investigator.
662741|NCT02118597|B1|Baseline|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662742|NCT02118597|P1|Participant Flow|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662743|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662744|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662745|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662767|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
662746|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662747|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662748|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
664356|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
662749|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662750|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662751|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662752|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662753|NCT02118597|O1|Outcome|Triple Combination Therapy|Participants with genotype 1 chronic hepatitis C infection and a history of unsuccessful treatment with pegylated interferon (peginterferon) alfa plus ribavirin, who received a triple combination therapy with boceprevir plus peg-interferon alfa-2a plus ribavirin, were observed.
662754|NCT02118597|E1|Reported Event|Triple Combination Therapy|Participants who demonstrated genotype 1 chronic hepatitis C infection and had a history of unsuccessful treatment with pegylated interferon (Peg-interferon) alfa + ribavirin, and who were subjected to receive a triple combination therapy with simeprevir or boceprevir plus peg-interferon alfa-2a and ribavirin were observed.
662755|NCT02118441|B3|Baseline|Total|Total of all reporting groups
662756|NCT02118441|B2|Baseline|Ultrasound|"Radial artery catheter insertion will be conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer will be used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) will be used. Colour flow doppler may also be used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
662757|NCT02118441|B1|Baseline|Direct Palpation|"Radial artery catheter insertion will be conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
662758|NCT02118441|P2|Participant Flow|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
662759|NCT02118441|P1|Participant Flow|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
662760|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
662761|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
662762|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
662763|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
662764|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
662765|NCT02118441|O1|Outcome|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
662766|NCT02118441|O2|Outcome|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may have also been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
664344|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
662768|NCT02118441|E2|Reported Event|Ultrasound|"Radial artery catheter insertion was conducted by ultrasound guidance. A Sono-site ilook 25 Ultrasound (Sono-site, Inc., Bothell, WA, USA) with a 10-5 MHz linear array ultrasound transducer was used.~At the discretion on the Anesthesiologist, an out-of-plane (i.e. needle plane at right angles to ultrasound plane) was used. Colour flow doppler may also have been used to identify the artery if necessary.~Ultrasound-guided Radial Artery Catheter Insertion"
662769|NCT02118441|E1|Reported Event|Direct Palpation|"Radial artery catheter insertion was conducted by direct palpation and use of anatomic knowledge by the Anesthesiologist.~Direct Palpation-guided Radial Artery Catheter insertion"
662770|NCT02117687|B3|Baseline|Total|Total of all reporting groups
662771|NCT02117687|B2|Baseline|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662772|NCT02117687|B1|Baseline|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662773|NCT02117687|P2|Participant Flow|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662774|NCT02117687|P1|Participant Flow|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662775|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662776|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662777|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662778|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662779|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662780|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662781|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662782|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662783|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662784|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662785|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662786|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662787|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662788|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662789|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662790|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662791|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662792|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662793|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662794|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662795|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662796|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662797|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662798|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662799|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662800|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662801|NCT02117687|O2|Outcome|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662802|NCT02117687|O1|Outcome|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662803|NCT02117687|E2|Reported Event|VISMED® Multi|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662804|NCT02117687|E1|Reported Event|OPTIVE FUSION™|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
662805|NCT02117570|B4|Baseline|Total|Total of all reporting groups
662806|NCT02117570|B3|Baseline|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662807|NCT02117570|B2|Baseline|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
664357|NCT02105012|E5|Reported Event|Placebo MDI|Placebo MDI.
662808|NCT02117570|B1|Baseline|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662809|NCT02117570|P3|Participant Flow|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662810|NCT02117570|P2|Participant Flow|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662811|NCT02117570|P1|Participant Flow|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662812|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662813|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662814|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662815|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662816|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662817|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662818|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662819|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662820|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662821|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662822|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662823|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662824|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662825|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662826|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662827|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662828|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662829|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662830|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662831|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662832|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662833|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662834|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662835|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662836|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662837|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662838|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
664345|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
662839|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662840|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662841|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662842|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
664358|NCT02105012|E4|Reported Event|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
662843|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662844|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662845|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662846|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662847|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662848|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662849|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662850|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662851|NCT02117570|O3|Outcome|Clostridium Difficile Vaccine, 200 µg|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662852|NCT02117570|O2|Outcome|Clostridium Difficile Vaccine, 100 µg|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662853|NCT02117570|O1|Outcome|Placebo|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662854|NCT02117570|E6|Reported Event|Clostridium Difficile Vaccine, 200 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662855|NCT02117570|E5|Reported Event|Clostridium Difficile Vaccine, 100 µg (65-85 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662856|NCT02117570|E4|Reported Event|Placebo (65-85 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662857|NCT02117570|E3|Reported Event|Clostridium Difficile Vaccine, 200 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 200 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662858|NCT02117570|E2|Reported Event|Clostridium Difficile Vaccine, 100 µg (50-64 Year Age Cohort)|Participants were vaccinated with C difficile vaccine, 100 µg, at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662859|NCT02117570|E1|Reported Event|Placebo (50-64 Year Age Cohort)|Participants were vaccinated with placebo at each vaccination visit (Days 1, 8, and 30) for a total of 3 vaccinations.
662860|NCT02117544|B1|Baseline|Overall|AIR OPTIX® AQUA Multifocal and lotrafilcon B Multifocal (new design) contact lenses worn during Period 1 and Period 2 in a crossover assignment.
662861|NCT02117544|P2|Participant Flow|AOAMF, Then New MF|Lotrafilcon B multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses (new). Each product worn bilaterally for about 1 hour.
662862|NCT02117544|P1|Participant Flow|New MF, Then AOAMF|Lotrafilcon B multifocal contact lenses (new), followed by lotrafilcon B multifocal contact lenses. Each product worn bilaterally for about 1 hour.
662863|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
662864|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
662865|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
662866|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
662867|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
662868|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
662869|NCT02117544|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn during Period 1 or Period 2 for 1 hour
662870|NCT02117544|O1|Outcome|New MF|Lotrafilcon B multifocal (new design) contact lenses worn during Period 1 or Period 2 for 1 hour
662871|NCT02117544|E3|Reported Event|AOAMF|Includes all subjects/eyes exposed to AOAMF
662872|NCT02117544|E2|Reported Event|New MF|Includes all subjects/eyes exposed to New MF
662873|NCT02117544|E1|Reported Event|Pre-treatment|Includes all enrolled subjects/eyes prior to exposure to the investigational products
662874|NCT02117414|B3|Baseline|Total|Total of all reporting groups
662875|NCT02117414|B2|Baseline|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662876|NCT02117414|B1|Baseline|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662905|NCT02117193|O4|Outcome|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
662877|NCT02117414|P2|Participant Flow|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662878|NCT02117414|P1|Participant Flow|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662879|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662880|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662881|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662882|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662883|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662884|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662885|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662886|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662887|NCT02117414|O1|Outcome|Implanted Subjects|All subjects who are successfully implanted with the Evera MRI Study System or have an implant attempt will be included in the analysis.
662888|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662889|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662890|NCT02117414|O2|Outcome|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662891|NCT02117414|O1|Outcome|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662892|NCT02117414|O1|Outcome|MRI Group|All subjects successfully implanted with the Evera MRI Study System who have an MRI scan at the MRI/waiting period visit and have completed their one month post-MRI scan follow-up, (or a later follow-up), or have had an MRI-related event without completion of their one-month post-MRI scan follow-up will be included in the analysis
662893|NCT02117414|E2|Reported Event|Control Group|"Subjects randomized to the Control group will wait for 1 hour without having a series of MRI scans at the waiting period visit (9-12 weeks post-implant).~Waiting Period Visit: Waiting period time will equate to 1 hour"
662894|NCT02117414|E1|Reported Event|MRI Group|"Subjects randomized to the MRI group will undergo a series of MRI scans at the MRI visit (9-12 weeks post-implant).~MRI scan sequences of the head and chest regions: Non-diagnostic MRI scans"
662895|NCT02117310|B1|Baseline|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
662896|NCT02117310|P1|Participant Flow|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
662897|NCT02117310|O1|Outcome|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
662898|NCT02117310|E1|Reported Event|ICG-Angiography With Administered ICG|Indocyanine green: ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
662899|NCT02117193|B1|Baseline|All Study Participants|Received Alcohol intake + Normal Sleep Received Alcohol intake + Sleep Deprivation Received Placebo intake + Normal Sleep Received Placebo intake + Sleep Deprivation
662900|NCT02117193|P1|Participant Flow|All Study Participants|This is a cross-over study.
662901|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
662902|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol, in the same volume that alcohol intake) before sleep.~Normal sleep: One night of normal sleep (8h)"
662903|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep Deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
662904|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
688043|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
662906|NCT02117193|O3|Outcome|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
662907|NCT02117193|O2|Outcome|Alcohol Intake + Sleep Deprivation|1g/kg of alcohol (beer) combined with 8 hours of sleep deprivation
662908|NCT02117193|O1|Outcome|Alcohol Intake + Normal Sleep|1g/kg of alcohol (beer) combined with 8 hours of normal sleep
662909|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
664359|NCT02105012|E3|Reported Event|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
662910|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Normal sleep: One night of normal sleep (8h)"
662911|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
662912|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
662913|NCT02117193|O4|Outcome|Sequence 4|"Placebo intake + Sleep deprivation~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
662914|NCT02117193|O3|Outcome|Sequence 3|"Placebo intake + Normal Sleep~Placebo intake: The subjects will be drink beer (zero alcohol) before sleep.~Normal sleep: One night of normal sleep (8h)"
662915|NCT02117193|O2|Outcome|Sequence 2|"Alcohol intake + Sleep deprivation~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Sleep deprivation: One night of sleep deprivation (8h)"
662916|NCT02117193|O1|Outcome|Sequence 1|"Alcohol intake + Normal Sleep~Alcohol intake: The subjects will be drink beer (1g/kg of ethanol) before sleep.~Normal sleep: One night of normal sleep (8h)"
662917|NCT02117193|E4|Reported Event|Placebo Intake + Sleep Deprivation|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of sleep deprivation
662918|NCT02117193|E3|Reported Event|Placebo Intake + Normal Sleep|Placebo (beer without alcohol in the same volume to beer with alcohol) combined with 8 hours of normal sleep
662919|NCT02117193|E2|Reported Event|Alcohol Intake + Sleep Deprivation|1 g/kg of etanol combined with 8 hours of sleep deprivation
662920|NCT02117193|E1|Reported Event|Alcohol Intake + Normal Sleep|1 g/kg of etanol combined with 8 hours of normal sleep
662921|NCT02117050|B1|Baseline|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662922|NCT02117050|P1|Participant Flow|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662923|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662924|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662925|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662926|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662927|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662928|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662929|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662930|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662931|NCT02117050|O1|Outcome|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662932|NCT02117050|E1|Reported Event|Rebif® Via Rebidose® Auto-injector|Rebif® was to be administered subcutaneously three times a week at a dose of 8.8 to 44 mcg in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
662933|NCT02116582|B1|Baseline|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
662934|NCT02116582|P1|Participant Flow|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
688044|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
662935|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
662936|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
664360|NCT02105012|E2|Reported Event|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
662937|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
662938|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
662939|NCT02116582|O1|Outcome|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
662940|NCT02116582|E1|Reported Event|Enzalutamide|Participants received 160 mg of enzalutamide orally once daily until they experienced an adverse event, disease progression, started new anti-cancer therapy, withdrew consent, or other protocol-specified criteria.
662941|NCT02116530|B3|Baseline|Total|Total of all reporting groups
662942|NCT02116530|B2|Baseline|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662943|NCT02116530|B1|Baseline|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662944|NCT02116530|P2|Participant Flow|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662945|NCT02116530|P1|Participant Flow|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662946|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662947|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662948|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662949|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662990|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
662991|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
664346|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
662993|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662994|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
664361|NCT02105012|E1|Reported Event|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
662950|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662951|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662952|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662953|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662954|NCT02116530|O2|Outcome|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662955|NCT02116530|O1|Outcome|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662956|NCT02116530|E2|Reported Event|Placebo|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as usual anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~placebo"
662957|NCT02116530|E1|Reported Event|Olanzapine|"Patients receive the chemotherapy drugs cisplatin or cyclophosphamide and doxorubicin as well as the following anti-nausea/vomiting drugs:~Ondansetron (8 mg orally or intravenously) or granisetron (1 mg intravenously or 2 mg orally) or palonosetron (0.25 mg intravenously) on the day of chemotherapy, plus~Dexamethasone (12 mg orally on the day of chemotherapy and 8 mg orally days 2, 3, 4 post chemotherapy), plus~Fosaprepitant (150 mg intravenously on the day of chemotherapy) or aprepitant (125 mg orally on the day of chemotherapy and 80 mg orally on days 2 and 3 post chemotherapy), plus~olanzapine (10 mg orally on the day of chemotherapy and 10 mg orally on days 2, 3, 4 post chemotherapy)"
662958|NCT02115984|B3|Baseline|Total|Total of all reporting groups
662959|NCT02115984|B2|Baseline|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662960|NCT02115984|B1|Baseline|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662961|NCT02115984|P2|Participant Flow|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662992|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
664347|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
662962|NCT02115984|P1|Participant Flow|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662963|NCT02115984|O2|Outcome|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662964|NCT02115984|O1|Outcome|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662965|NCT02115984|E2|Reported Event|Chemotherapy & Placebo|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Placebo tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the placebo tablets immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662966|NCT02115984|E1|Reported Event|Chemotherapy & Panagen|"Chemotherapy: Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.~Panagen 5 mg tablet by mouth every 2-3 h (six times a day) for 18 days. Patients start to receive the preparation immediately after the chemotherapy and take three tablets during 6 h, that is one tablet every 2 h. Then the patients stop taking the preparation and resume its administration after 42 h, that is, 48 h after the chemotherapy (Day 3) and continue its administration for 17 days (to Day 20 after the chemotherapy)."
662967|NCT02115815|B8|Baseline|Total|Total of all reporting groups
662968|NCT02115815|B7|Baseline|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662969|NCT02115815|B6|Baseline|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
662970|NCT02115815|B5|Baseline|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662971|NCT02115815|B4|Baseline|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
662972|NCT02115815|B3|Baseline|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662973|NCT02115815|B2|Baseline|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
662974|NCT02115815|B1|Baseline|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
662975|NCT02115815|P7|Participant Flow|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662976|NCT02115815|P6|Participant Flow|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
662977|NCT02115815|P5|Participant Flow|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662978|NCT02115815|P4|Participant Flow|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
662979|NCT02115815|P3|Participant Flow|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662980|NCT02115815|P2|Participant Flow|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
662981|NCT02115815|P1|Participant Flow|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
662982|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662983|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
662984|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662985|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
662986|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662987|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
662988|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
662989|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662995|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
662996|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662997|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
662998|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
662999|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663000|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663001|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663002|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663003|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663004|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663005|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663006|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663007|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663008|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663009|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663010|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663011|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663012|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663013|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663014|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663015|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663016|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663017|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663018|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663019|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663020|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663021|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663022|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663023|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663024|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663025|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663026|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663027|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663028|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663029|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663030|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663643|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
663031|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663032|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663033|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663034|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663035|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663036|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663037|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663038|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663039|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663040|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663041|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663042|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663043|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663044|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663045|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663046|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663047|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663048|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663049|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663050|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663051|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663052|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663053|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663054|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663055|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663056|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663057|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663058|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663059|NCT02115815|O7|Outcome|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663060|NCT02115815|O6|Outcome|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663061|NCT02115815|O5|Outcome|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663062|NCT02115815|O4|Outcome|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663063|NCT02115815|O3|Outcome|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663064|NCT02115815|O2|Outcome|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663065|NCT02115815|O1|Outcome|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663066|NCT02115815|E7|Reported Event|MEDI7510 80 Microgram (mcg)|Participants received single dose of MEDI7510 (80 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663067|NCT02115815|E6|Reported Event|RSV sF 80 Microgram (mcg)|Participants received single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
663068|NCT02115815|E5|Reported Event|MEDI7510 50 Microgram (mcg)|Participants received single dose of MEDI7510 (50 mcg RSV sF with 2.5 mcg GLA in 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663644|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
663069|NCT02115815|E4|Reported Event|RSV sF 50 Microgram (mcg)|Participants received single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
663137|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
663070|NCT02115815|E3|Reported Event|MEDI7510 20 Microgram (mcg)|Participants received single dose of MEDI7510 (20 mcg RSV sF with 2.5 mcg glucopyranosyl lipid A [GLA] + 2% weight per volume stable emulsion) by intramuscular injection on Day 1.
663071|NCT02115815|E2|Reported Event|RSV sF 20 Microgram (mcg)|Participants received single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
663072|NCT02115815|E1|Reported Event|Placebo|Participants received placebo (sterile saline for human use from commercial source, liquid) by intramuscular injection on Day 1.
663073|NCT02115581|B3|Baseline|Total|Total of all reporting groups
663074|NCT02115581|B2|Baseline|Placebo|known cases of idiopathic dilated cardiomyopathy who received the placebo
663075|NCT02115581|B1|Baseline|Conezyme Q10|known cases of idiopathic dilated cardiomyopathy who received Co Q10
663076|NCT02115581|P2|Participant Flow|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
663077|NCT02115581|P1|Participant Flow|Coenzyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
663078|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
663079|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
663080|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
663081|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
663082|NCT02115581|O2|Outcome|Placebo|Known cases of idiopathic dilated cardiomyopathy who received the placebo
663083|NCT02115581|O1|Outcome|Conezyme Q10|Known cases of idiopathic dilated cardiomyopathy who received Co Q10
663084|NCT02115581|E2|Reported Event|Placebo (Control Group)|"Known cases of idiopathic dilated cardiomyopathy~Placebo: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
663085|NCT02115581|E1|Reported Event|Coenzyme Q10 (Study Group)|"Known cases of idiopathic dilated cardiomyopathy~Coenzyme Q10: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient’s tolerance"
663086|NCT02115321|B3|Baseline|Total|Total of all reporting groups
663087|NCT02115321|B2|Baseline|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663088|NCT02115321|B1|Baseline|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663089|NCT02115321|P2|Participant Flow|Part A: NC GZR 100 mg + EBR 50 mg|Non-cirrhotic (NC) participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663090|NCT02115321|P1|Participant Flow|Part A: CP-B GZR 50 mg + EBR 50 mg|Child-Pugh score 7 to 9 (CP-B) participants take GZR 50 mg + EBR 50 mg once daily (q.d.) by mouth for 12 weeks.
663091|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663092|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663093|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663094|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663095|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663096|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663097|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663098|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663099|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663100|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663101|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663102|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663103|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663104|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663105|NCT02115321|O2|Outcome|Part A: NC GZR 100 mg + ER 50 mg|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663106|NCT02115321|O1|Outcome|Part A: CP-B GZR 50 mg + EBR 50 mg|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663107|NCT02115321|E2|Reported Event|Non-cirrhotic: GZR 100 mg + EBR 50 mg for 12 Weeks|NC participants take GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663108|NCT02115321|E1|Reported Event|CP-B: GZR 50 mg + EBR 50 mg for 12 Weeks|CP-B participants take GZR 50 mg + EBR 50 mg q.d. by mouth for 12 weeks.
663109|NCT02115256|B3|Baseline|Total|Total of all reporting groups
663110|NCT02115256|B2|Baseline|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
663111|NCT02115256|B1|Baseline|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
663136|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663207|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
664362|NCT02104895|B3|Baseline|Total|Total of all reporting groups
704928|NCT01825122|E1|Reported Event|Placebo|"placebo~Placebo"
663112|NCT02115256|P2|Participant Flow|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
663113|NCT02115256|P1|Participant Flow|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
663114|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
663115|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
663116|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
663117|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
663118|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
663119|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
663120|NCT02115256|O2|Outcome|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
663121|NCT02115256|O1|Outcome|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
663122|NCT02115256|E2|Reported Event|Intravenous Nitroglycerine|"IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.~Intravenous Nitroglycerine: The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it’s short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms."
663123|NCT02115256|E1|Reported Event|Intravenous Terbutaline|"0.25 mL of Intravenous Terbutaline~Intravenous Terbutaline: 0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline."
663124|NCT02114931|B3|Baseline|Total|Total of all reporting groups
663125|NCT02114931|B2|Baseline|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
663126|NCT02114931|B1|Baseline|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663127|NCT02114931|P2|Participant Flow|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
663128|NCT02114931|P1|Participant Flow|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663129|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
663130|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663131|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
663132|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663133|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
663134|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663135|NCT02114931|O2|Outcome|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
664348|NCT02105012|O4|Outcome|BD MDI 40 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg
663138|NCT02114931|O1|Outcome|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663139|NCT02114931|E2|Reported Event|Adalimumab/ABP 501|Participants who received adalimumab in the parent study transitioned to receive ABP 501 40 mg subcutaneously every other week for 18 months.
663140|NCT02114931|E1|Reported Event|ABP 501/ABP 501|Participants who received ABP 501 in the parent study continued to receive ABP 501 40 mg subcutaneously (SC) every other week for an additional 18 months (total of 24-months treatment).
663141|NCT02114892|B3|Baseline|Total|Total of all reporting groups
663142|NCT02114892|B2|Baseline|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663143|NCT02114892|B1|Baseline|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663144|NCT02114892|P2|Participant Flow|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663145|NCT02114892|P1|Participant Flow|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663146|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663147|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663148|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663149|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663150|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663151|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663152|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663153|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663154|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663155|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663156|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663157|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663158|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663159|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663160|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663161|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663162|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663163|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663164|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663165|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663166|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663167|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663168|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663169|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663170|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663171|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663172|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663173|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663174|NCT02114892|O2|Outcome|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663175|NCT02114892|O1|Outcome|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663176|NCT02114892|E2|Reported Event|Placebo|"Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days~Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg"
663177|NCT02114892|E1|Reported Event|Resveratrol|"Resveratrol capsules, 500 mg, three times per day before meals during 90 days~Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day."
663178|NCT02114268|B7|Baseline|Total|Total of all reporting groups
663179|NCT02114268|B6|Baseline|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663180|NCT02114268|B5|Baseline|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663181|NCT02114268|B4|Baseline|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663182|NCT02114268|B3|Baseline|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663183|NCT02114268|B2|Baseline|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663184|NCT02114268|B1|Baseline|Placebo|Participants received placebo on Day 1.
663185|NCT02114268|P6|Participant Flow|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663186|NCT02114268|P5|Participant Flow|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663187|NCT02114268|P4|Participant Flow|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663188|NCT02114268|P3|Participant Flow|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663189|NCT02114268|P2|Participant Flow|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663190|NCT02114268|P1|Participant Flow|Placebo|Participants received placebo on Day 1.
663191|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663192|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663193|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663194|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663195|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663196|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
663197|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663198|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663199|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663200|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663201|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663202|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663203|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663204|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663205|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663206|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
688045|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
663208|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663209|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663210|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663211|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663212|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663213|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663214|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663215|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663216|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663217|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663218|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663219|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663220|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663221|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663222|NCT02114268|O5|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663223|NCT02114268|O4|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663224|NCT02114268|O3|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663225|NCT02114268|O2|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663226|NCT02114268|O1|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663227|NCT02114268|O6|Outcome|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663228|NCT02114268|O5|Outcome|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663229|NCT02114268|O4|Outcome|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663230|NCT02114268|O3|Outcome|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663231|NCT02114268|O2|Outcome|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663232|NCT02114268|O1|Outcome|Placebo|Participants received placebo on Day 1.
663233|NCT02114268|E6|Reported Event|MEDI8897 300 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
663234|NCT02114268|E5|Reported Event|MEDI8897 100 Milligram (mg) Intramuscular (IM)|Participants received single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
663235|NCT02114268|E4|Reported Event|MEDI8897 3000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
663236|NCT02114268|E3|Reported Event|MEDI8897 1000 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
663237|NCT02114268|E2|Reported Event|MEDI8897 300 Milligram (mg) Intravenous (IV)|Participants received single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
663238|NCT02114268|E1|Reported Event|Placebo|Participants received placebo on Day 1.
663239|NCT02114216|B4|Baseline|Total|Total of all reporting groups
663240|NCT02114216|B3|Baseline|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
663241|NCT02114216|B2|Baseline|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
663242|NCT02114216|B1|Baseline|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
663243|NCT02114216|P3|Participant Flow|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
663244|NCT02114216|P2|Participant Flow|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
663245|NCT02114216|P1|Participant Flow|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
663246|NCT02114216|O3|Outcome|NERD Group|"Subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
663247|NCT02114216|O2|Outcome|ERD Group|"Subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
663645|NCT02108288|E3|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
663411|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663248|NCT02114216|O1|Outcome|Control Group|"Subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms. Endoscopic mucosal biopsy was done for every subject.~endoscopic mucosal biopsy: endoscopic mucosal biopsy was undertaken for every participant."
663249|NCT02114216|O3|Outcome|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
663250|NCT02114216|O2|Outcome|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
663251|NCT02114216|O1|Outcome|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
663252|NCT02114216|E3|Reported Event|NERD Group|subjects who do not have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and complain of GERD symptoms
663253|NCT02114216|E2|Reported Event|ERD Group|subjects who have mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and/or complain of GERD symptoms
663254|NCT02114216|E1|Reported Event|Control Group|subjects who do not show mucosal breaks in the upper GI endoscopy consistent with reflux esophagitis and do not complain of GERD symptoms
663255|NCT02114177|B3|Baseline|Total|Total of all reporting groups
663256|NCT02114177|B2|Baseline|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663257|NCT02114177|B1|Baseline|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663258|NCT02114177|P2|Participant Flow|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663259|NCT02114177|P1|Participant Flow|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663260|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663261|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663262|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663263|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663264|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663265|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663266|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663267|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663268|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663269|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663270|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663271|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663272|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663273|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663274|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663275|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663276|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663277|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663278|NCT02114177|O2|Outcome|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663279|NCT02114177|O1|Outcome|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663280|NCT02114177|E2|Reported Event|Simeprevir and Sofosbuvir for 12 Weeks|Participants received 1 capsule of 150 mg simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 12 weeks.
663281|NCT02114177|E1|Reported Event|Simeprevir and Sofosbuvir for 8 Weeks|Participants received 1 capsule of 150 milligram (mg) simeprevir and 1 tablet of 400 mg sofosbuvir orally (by mouth) once daily for 8 weeks.
663646|NCT02108288|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
663282|NCT02114151|B1|Baseline|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663283|NCT02114151|P1|Participant Flow|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663284|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663285|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663286|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663287|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663288|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663289|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663290|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663291|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663292|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663293|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663294|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663295|NCT02114151|O1|Outcome|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663296|NCT02114151|E1|Reported Event|Simeprevir Plus Sofosbuvir|Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.
663297|NCT02113579|B3|Baseline|Total|Total of all reporting groups
663298|NCT02113579|B2|Baseline|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663299|NCT02113579|B1|Baseline|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663300|NCT02113579|P2|Participant Flow|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663301|NCT02113579|P1|Participant Flow|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663302|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663303|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663304|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663305|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663306|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663307|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663308|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663309|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663310|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663311|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663312|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663313|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663314|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663315|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663316|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663317|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663318|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663319|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663320|NCT02113579|O2|Outcome|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663321|NCT02113579|O1|Outcome|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663322|NCT02113579|E2|Reported Event|12027-033|Experimental Mouth Rinse 12027-033 (10 mL) twice daily after brushing
663323|NCT02113579|E1|Reported Event|Placebo Control|Placebo Mouth Rinse (10 mL) twice daily after brushing
663324|NCT02113449|B1|Baseline|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663325|NCT02113449|P1|Participant Flow|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663326|NCT02113449|O1|Outcome|CO2 Nasal Spray|Score from 1 to 7 indicates how much or how little you think the statement applies to this product. A score of 1 indicates that the statement does not apply at all to the product that you used. A score of 7 indicates that it applies completely to it
663327|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663407|NCT02111252|B1|Baseline|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663328|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663329|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663330|NCT02113449|O1|Outcome|CO2 Nasal Spray|
663331|NCT02113449|O1|Outcome|C02 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663332|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663333|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663334|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663335|NCT02113449|O1|Outcome|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663336|NCT02113449|O1|Outcome|All Participants|"The participants were asked in the beginning which medication they purchase to relieve nasal congestion. Participant could select only one option available. If the participant answered I do not purchase any product to relieve congestion the participant was excluded. Participants could select only one option available."
663337|NCT02113449|E1|Reported Event|CO2 Nasal Spray|CO2 spray was administered for 10 seconds per nostril. Participants received one dose of nasal CO2 in the study clinic under medical supervision, followed by an additional six days of at home use, up to 4 times per day
663338|NCT02113436|B3|Baseline|Total|Total of all reporting groups
663339|NCT02113436|B2|Baseline|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663340|NCT02113436|B1|Baseline|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663341|NCT02113436|P4|Participant Flow|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1.
663342|NCT02113436|P3|Participant Flow|FP HFA 50 µg - FP/SLM HFA 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
663343|NCT02113436|P2|Participant Flow|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663344|NCT02113436|P1|Participant Flow|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663345|NCT02113436|O2|Outcome|FP/SLM 50/25 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP/SLM HFA MDI 50/25 μg in TP1
663346|NCT02113436|O1|Outcome|FP 50 µg - FP/SLM 50/25 µg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg in TP1.
663347|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663348|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663349|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663350|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663351|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663352|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663353|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663354|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663355|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663356|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663410|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663357|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663358|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663359|NCT02113436|O2|Outcome|FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663360|NCT02113436|O1|Outcome|FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663361|NCT02113436|E3|Reported Event|Period 2 - FP/SLM HFA 50/25 μg|1 or 2 inhalations of FP/SLM HFA MDI 50/25 μg were administered twice daily in TP2 to those participants who received FP HFA MDI 50 μg or FP/SLM HFA MDI 50/25 µg in TP1.
663362|NCT02113436|E2|Reported Event|Period 1 - FP/SLM HFA 50/25 µg|In TP1, participants were randomized to receive one or two inhalations of FP/SLM HFA 50/25 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663363|NCT02113436|E1|Reported Event|Period 1 - FP HFA 50 µg|In TP1, participants were randomized to receive one or two inhalations of FP HFA 50 µg BID for 8 weeks via a MDI using AeroChamber Plus with face mask. Salbutamol was provided as a rescue medication.
663364|NCT02113124|B3|Baseline|Total|Total of all reporting groups
663365|NCT02113124|B2|Baseline|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
663366|NCT02113124|B1|Baseline|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
663367|NCT02113124|P2|Participant Flow|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
663368|NCT02113124|P1|Participant Flow|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
663369|NCT02113124|O2|Outcome|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
663370|NCT02113124|O1|Outcome|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
663371|NCT02113124|E2|Reported Event|Uninjured Control|This group of individuals have no history of brain injury. Ages range between 35 and 70.
663372|NCT02113124|E1|Reported Event|Chronic Brain Injury|Individuals in this group have suffered a brain injury more than 2 years prior to study. Ages range from 35 to 70.
663373|NCT02113007|B1|Baseline|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
663374|NCT02113007|P1|Participant Flow|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
663375|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
663376|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
663377|NCT02113007|O1|Outcome|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
663378|NCT02113007|E1|Reported Event|Rituximab Plus Temozolomide|"Rituximab: 375 mg/m2 IV, days 1, 3, and 5 Temozolomide: 150 mg/m2 PO, days 1-5~Rituximab plus Temozolomide: Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles."
663379|NCT02112448|B3|Baseline|Total|Total of all reporting groups
663380|NCT02112448|B2|Baseline|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663408|NCT02111252|P1|Participant Flow|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663409|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663381|NCT02112448|B1|Baseline|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663382|NCT02112448|P2|Participant Flow|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663383|NCT02112448|P1|Participant Flow|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663384|NCT02112448|O2|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663385|NCT02112448|O1|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663386|NCT02112448|O2|Outcome|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663387|NCT02112448|O1|Outcome|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663388|NCT02112448|E2|Reported Event|Continuous Infusion|"Patients in this group will received morphine/midazolam drips at 0.3 mg/kg/hour each. They will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~continuous infusion: This arm will receive continuous morphine/midazolam and 'as needed' doses. This group will receive adjunctive medications, acetaminophen and ketorolac.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663389|NCT02112448|E1|Reported Event|As Needed Dosing|"Patients in this arm will be given doses of morphine 0.05 mg/kg/dose every 2 hours as needed for pain score 4 or more. Midazolam will also be given as needed (0.05 mg/kg/dose every 1 hour)~as needed dosing: This group will receive morphine and midazolam as needed to control their pain. Acetaminophen and ketorolac will also be given for pain control in the same manner as the continuous infusion group.~Acetaminophen: Acetaminophen will be given as a loading dose of 30 mg/kg rectally post surgery to all subjects and then 15 mg/kg every 4 hours for a total of 24 hours.~ketorolac: Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study."
663390|NCT02111603|B1|Baseline|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663391|NCT02111603|P1|Participant Flow|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663392|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663393|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663394|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663395|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663396|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663397|NCT02111603|O1|Outcome|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663398|NCT02111603|E1|Reported Event|Colesevelam|1875 mg of Colesevelam orally twice daily for 10 days
663647|NCT02108288|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
663399|NCT02111369|B1|Baseline|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
663400|NCT02111369|P1|Participant Flow|Propranolol/Botulinum|"After baseline analysis, patient will be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile. After second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
663401|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
663402|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
663403|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
663404|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
663405|NCT02111369|O1|Outcome|Propranolol/Botulinum|"After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.~Propranolol: After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days"
663406|NCT02111369|E1|Reported Event|Propranolol/Botulinum|After baseline analysis, participants were given a prescription by the principal investigator for propranolol. This prescription consisted of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the participant demonstrated no side effects. Dose was increased up to 240 mg a day depending on participant improvement and side effect profile. After second evaluation, participants received botulinum toxin injections. The risks and benefits of botulinum toxin therapy were explained to the participant, and bilateral injections took place.
663648|NCT02107196|B3|Baseline|Total|Total of all reporting groups
663412|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663413|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663414|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663415|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663416|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663417|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663418|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663419|NCT02111252|O1|Outcome|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663420|NCT02111252|E1|Reported Event|TAK-850 0.5 mL|A single dose of 0.5 mL TAK-850 (15 µg of hemagglutinin [HA] antigen per strain) is injected into the deltoid muscle.
663421|NCT02111083|B3|Baseline|Total|Total of all reporting groups
663422|NCT02111083|B2|Baseline|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100 (reference [R] on 2 occasions). Subjects were randomly assigned to dosing sequences RTRT.
663423|NCT02111083|B1|Baseline|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A U-200 (test [T] on 2 occasions) and insulin lispro B U-100(reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
663424|NCT02111083|P2|Participant Flow|Insulin Lispro Dosing Sequence RTRT|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences RTRT.
663425|NCT02111083|P1|Participant Flow|Insulin Lispro Dosing Sequence TRTR|Each subject was administered insulin lispro A 20 units (U) of strength 200 units per milliliter (U/mL) (U-200) (test [T] on 2 occasions) and insulin lispro B 20 units (U) of strength 100 U/mL (U-100) (reference [R] on 2 occasions).Subjects were randomly assigned to dosing sequences TRTR.
663426|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663427|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663428|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663429|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663430|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663431|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663432|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663433|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663434|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663435|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663436|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663437|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663438|NCT02111083|O2|Outcome|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663439|NCT02111083|O1|Outcome|Insulin Lispro A|Insulin Lispro A U-200 administered subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663440|NCT02111083|E2|Reported Event|Insulin Lispro B|Insulin Lispro B U-100 administered SC once in two of four study periods. (Two doses of reference [R]).
663441|NCT02111083|E1|Reported Event|Insulin Lispro A|Insulin Lispro A U-200 subcutaneously (SC) once in two of four study periods. (Two doses of test [T]).
663442|NCT02110381|B3|Baseline|Total|Total of all reporting groups
663443|NCT02110381|B2|Baseline|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
663475|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
663476|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
663477|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
663478|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
663444|NCT02110381|B1|Baseline|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
663445|NCT02110381|P2|Participant Flow|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
663446|NCT02110381|P1|Participant Flow|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
663447|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
663448|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
663449|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
663450|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
663451|NCT02110381|O2|Outcome|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
663452|NCT02110381|O1|Outcome|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
663453|NCT02110381|E3|Reported Event|Screen Failures|These subjects reflect individuals who: 1) consented to be in the study, 2) participated in the initial run-in period to evaluate blood pressure, 3) ended up not meeting the blood pressure criteria required for randomization
663454|NCT02110381|E2|Reported Event|Isometric Hand Grip|"Participants will first do isometric hand grip exercises for 8 weeks, followed by 8 weeks of doing BOTH the hand grip exercises AND the device guided breathing.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
663455|NCT02110381|E1|Reported Event|Device Guided Breathing|"Participants will first do device guided breathing for 8 weeks, followed by 8 weeks of doing BOTH the device guided breathing AND the hand grip exercises.~Device guided breathing: Participants will use a device (RESPeRATE) to guide them through slow controlled breathing, with a goal of about ten breaths per minute.~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit.~Isometric hand grip: Participants will use a device (Zona Plus) which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
663456|NCT02110238|B3|Baseline|Total|Total of all reporting groups
663457|NCT02110238|B2|Baseline|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
663458|NCT02110238|B1|Baseline|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
663459|NCT02110238|P2|Participant Flow|Supartz|"SUPARTZ® (hyaluronic acid of avian origin)~Supartz: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
663460|NCT02110238|P1|Participant Flow|Euflexxa|"Euflexxa® (hyaluronic acid of bacterial origin)~Euflexxa: Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2."
663461|NCT02110238|O2|Outcome|Supartz|SUPARTZ® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
663462|NCT02110238|O1|Outcome|Euflexxa|Euflexxa® Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
663463|NCT02110238|E2|Reported Event|Supartz|SUPARTZ® (hyaluronic acid of avian origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
663464|NCT02110238|E1|Reported Event|Euflexxa|Euflexxa® (hyaluronic acid of bacterial origin) Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
663465|NCT02109731|B1|Baseline|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
663466|NCT02109731|P1|Participant Flow|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
663467|NCT02109731|O1|Outcome|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
663468|NCT02109731|E1|Reported Event|Negative Airway Pressure Delivery|"Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.~Negative airway pressure delivery: Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep."
663469|NCT02109640|B3|Baseline|Total|Total of all reporting groups
663470|NCT02109640|B2|Baseline|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
663471|NCT02109640|B1|Baseline|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
663472|NCT02109640|P2|Participant Flow|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
663473|NCT02109640|P1|Participant Flow|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
663474|NCT02109640|O2|Outcome|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
663573|NCT02108977|B3|Baseline|Total|Total of all reporting groups
663479|NCT02109640|O1|Outcome|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
663480|NCT02109640|E2|Reported Event|Oxycodone|"Oral oxycodone 10-20mg bd following laparoscopic segmental colectomy~Oxycodone: Postoperative analgesia~Laparoscopic segmental colectomy"
663481|NCT02109640|E1|Reported Event|Targinact|"Oral Targinact 10-20mg bd following laparoscopic segmental colectomy~Targinact: Post-operative analgesia~Laparoscopic segmental colectomy"
663482|NCT02109497|B1|Baseline|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
663483|NCT02109497|P1|Participant Flow|Caffeine Dosing|Single dose of caffeine 100 mg administered on Day 1 and Day 12 with PBT2 250 mg administered from Day 8 to 12.
663484|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
663485|NCT02109497|O1|Outcome|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
663486|NCT02109497|E1|Reported Event|Caffeine Dosing|"Single dose of caffeine 100 mg administered on Day 1 and Day 12~PBT2: PBT2 250 mg administered is Day 8 to 12."
663487|NCT02109458|B1|Baseline|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
663488|NCT02109458|P1|Participant Flow|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex Endobronchial Ultrasound (EBUS) lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
663489|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
663490|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
663491|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
663492|NCT02109458|O1|Outcome|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
663493|NCT02109458|E1|Reported Event|Assessing Peripheral Pulmonary Nodules|"To evaluate the feasibility and safety of a procedure path including convex EBUS lymph node sampling, navigation guided bronchoscopy (NB) and navigation guided transthoracic needle aspiration (N-TTNA).~Navigation guided bronchoscopy"
663494|NCT02109445|B1|Baseline|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663495|NCT02109445|P1|Participant Flow|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663496|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663497|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663498|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663499|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
688046|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
663694|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663500|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663501|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663502|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663503|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663504|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663505|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663506|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663507|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663508|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663509|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663510|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663511|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663574|NCT02108977|B2|Baseline|Telephone Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
664349|NCT02105012|O3|Outcome|BD MDI 80 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg
663512|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663513|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663514|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663515|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663516|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663517|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663518|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663519|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663520|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663521|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663522|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663523|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663575|NCT02108977|B1|Baseline|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
688047|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
663524|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663525|NCT02109445|O1|Outcome|PF-03084014 + Nab-Paclitaxel + Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663526|NCT02109445|E1|Reported Event|PF-03084014+Nab-Paclitaxel+Gemcitabine|PF-03084014 was administered twice daily (BID) orally via tablets at a starting dose of 100 milligrams (mg). Nab-paclitaxel (nab-P) and gemcitabine (GEM) were administered intravenously at a starting dose of 125 mg/square meter (m^2) and 1000 mg/m^2, respectively. Decisions to escalate, de-escalate or stay at the same dose were made based on the number of dose-limiting toxicities (DLTs) observed. In any case, PF-03084014 dose was not to exceed 150 mg BID and nab-P and GEM were not to exceed 125 mg/m^2 and 1000 mg/m^2, respectively.
663527|NCT02109172|B1|Baseline|Entire Study Population|All groups were randomized to receive placebo, TD-4208 44mcg twice daily, and TD-4208 175 mcg once daily
663528|NCT02109172|P6|Participant Flow|175mcg First, Then Placebo, Then 44mcg|175mcg once daily for 7 days then placebo twice daily for 7 days then 44mcg twice daily for 7 days
663529|NCT02109172|P5|Participant Flow|175mcg First, Then 44mcg, Then Placebo|175mcg once daily for 7 days then 44mcg twice daily for 7 days then placebo twice daily for 7 days
663530|NCT02109172|P4|Participant Flow|44mcg First, Then Placebo, Then 175mcg|44mcg twice daily for 7 days then placebo twice daily for 7 days then 175mcg once daily for 7 days
663531|NCT02109172|P3|Participant Flow|44mcg First, Then 175mcg, Then Placebo|44mcg twice daily for 7 days then 175mcg once daily for 7 days then placebo twice daily for 7 days
663532|NCT02109172|P2|Participant Flow|Placebo First, Then 175mcg, Then 44mcg|Placebo twice daily for 7 days then 175mcg once daily for 7 days then 44mcg twice daily for 7 days
663533|NCT02109172|P1|Participant Flow|Placebo First, Then 44mcg, Then 175mcg|Placebo twice daily for 7 days then 44mcg twice daily for 7 days then 175mcg once daily for 7 days
663534|NCT02109172|O3|Outcome|TD-4208 175 mcg Once Daily|"TD-4208 inhalation solution 175 mcg once daily, placebo once daily~TD-4208~Placebo"
663535|NCT02109172|O2|Outcome|TD-4208 44 mcg Twice Daily|"TD-4208 inhalation solution 44 mcg twice daily for 7 days~TD-4208"
663536|NCT02109172|O1|Outcome|Placebo|"Placebo inhalation solution twice daily for 7 days~Placebo"
663537|NCT02109172|E3|Reported Event|TD-4208 175mcg Once Daily|TD-4208 inhalation solution 175 mcg once daily
663538|NCT02109172|E2|Reported Event|TD-4208 44mcg Twice Daily|TD-4208 inhalation solution 44 mcg twice daily for 7 days
663539|NCT02109172|E1|Reported Event|Placebo|Placebo inhalation solution twice daily for 7 days
663540|NCT02109159|B3|Baseline|Total|Total of all reporting groups
663541|NCT02109159|B2|Baseline|Control Video|a short online video (2”43 minutes long) about the WOMAN trial with less emotional content (the interviewer provides a second hand description of the experience)
663542|NCT02109159|B1|Baseline|Emotional Video|a short online video (2”43 minutes long) about the WOMAN trial with more emotional content (an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience)
663543|NCT02109159|P2|Participant Flow|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
663544|NCT02109159|P1|Participant Flow|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
663545|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
663546|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
663547|NCT02109159|O2|Outcome|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
663548|NCT02109159|O1|Outcome|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
663549|NCT02109159|E2|Reported Event|Control Video|"A short online video with less emotional content, the interviewer provides a second hand description of the experience of a postpartum hemorrhage survivor and her husband.~A short online video with less emotional content"
663550|NCT02109159|E1|Reported Event|Emotional Video|"A short online video with emotional content, an interview with a postpartum haemorrhage survivor and her husband in which they describe their experience.~A short online video with emotional content"
663551|NCT02109133|B3|Baseline|Total|Total of all reporting groups
663552|NCT02109133|B2|Baseline|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
663553|NCT02109133|B1|Baseline|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
663576|NCT02108977|P2|Participant Flow|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
664350|NCT02105012|O2|Outcome|BD MDI 160 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg
663554|NCT02109133|P2|Participant Flow|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
663555|NCT02109133|P1|Participant Flow|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
663556|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
663557|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
663558|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
663559|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
663560|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
663561|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
663562|NCT02109133|O2|Outcome|Deep Neuromuscular Blockade (Deep NMB Group)|Deep NMB Group included patients who received an intravenous (IV) rocuronium bolus (1.0 mg kg-1) following the continuous infusion of 0.6 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a post-tetanic count (PTC) of 1 to 2. Sugammadex was administered to reverse the effects of NMB after surgery.
663563|NCT02109133|O1|Outcome|Moderate Neuromuscular Blockade (Moderate NMB Group)|Moderate NMB Group included patients who received an IV atracurium bolus (0.5 mg kg-1) following the continuous infusion of 0.3 mg kg-1 until the end of the ST position. Dose titration was assigned to an attending anaesthetist via regulation of the bolus infusion speed to maintain a TOF count of 1 to 2. Neostigmine was used to reverse the effects of NMB after surgery.
663564|NCT02109133|E2|Reported Event|Deep Neuromuscular Blockade|"deep neuromuscular blockade: deep neuromuscular blockade using rocuronium and reverse with sugammadex~Rocuronium~Sugammadex"
663565|NCT02109133|E1|Reported Event|Moderate Neuromuscular Blockade|"moderate neuromuscular blockade: moderate neuromuscular blockade using atracurium and reverse with neostigmine~Atracurium~Neostigmine"
663566|NCT02109107|B1|Baseline|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
663567|NCT02109107|P1|Participant Flow|Erchonia® Zerona 6 Headed Scanner (EZ6) Laser|"The Erchonia® Zerona 6 Headed Scanner (EZ6) Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
663568|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
663569|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
663570|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
663571|NCT02109107|O1|Outcome|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
663572|NCT02109107|E1|Reported Event|Erchonia EZ6 Laser|"The Erchonia EZ6 Laser is a 6 headed scanner composed of 6 independent 17 milliWatts (mW), 635 nanometer (nm) red laser diodes mounted in scanner devices. It is a variable frequency, pulsed wave laser device.~Erchonia EZ6 Laser: The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes."
663577|NCT02108977|P1|Participant Flow|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
663578|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
663579|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
663580|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
663581|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
663582|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
663583|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
663584|NCT02108977|O2|Outcome|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
663585|NCT02108977|O1|Outcome|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
663586|NCT02108977|E2|Reported Event|Teleconferencing Genetic Consultation|"Patients will receive genetic counseling session via telephone (usual treatment)~Teleconferencing Genetic Consultation: Patients will receive genetic counseling session via telephone (usual treatment)"
663587|NCT02108977|E1|Reported Event|Videoconferencing Genetic Consultation|"Patients will travel to CBOC and receive genetic counseling session via videoconferencing~Videoconferencing Genetic Consultation: Patients will travel to CBOC and receive genetic counseling session via videoconferencing"
663588|NCT02108691|B3|Baseline|Total|Total of all reporting groups
663589|NCT02108691|B2|Baseline|Placebo|Placebo: Placebo (2.5g/day)
663590|NCT02108691|B1|Baseline|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663591|NCT02108691|P2|Participant Flow|Placebo|Placebo: Placebo (2.5g/day)
663592|NCT02108691|P1|Participant Flow|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663593|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
663594|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663595|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
663596|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663597|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
663598|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663599|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
663600|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663601|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
663602|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663603|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
663604|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663605|NCT02108691|O2|Outcome|Placebo|Placebo: Placebo (2.5g/day)
663606|NCT02108691|O1|Outcome|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663607|NCT02108691|E2|Reported Event|Placebo|Placebo: Placebo (2.5g/day)
663608|NCT02108691|E1|Reported Event|Glycin Max(L.) Merr. Pell Extract|Glycin max(L.) Merr. peel extract: Glycin max(L.) Merr. peel extract (2.5g/day)
663609|NCT02108652|B1|Baseline|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663610|NCT02108652|P1|Participant Flow|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663611|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663612|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663639|NCT02108288|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
688048|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
663613|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663614|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663615|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663616|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663617|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663618|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663619|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663620|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663621|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663622|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663623|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663624|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663625|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663626|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663627|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663628|NCT02108652|O1|Outcome|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663629|NCT02108652|E1|Reported Event|Cohort 2: Participants With Second-line or Beyond Treatments|Participants who had disease progression during or following treatment with at least one platinum-containing chemotherapy regimen in the metastatic setting received atezolizumab 1200 mg via IV infusion on Day 1 of 21-day cycles until loss of clinical benefit or unmanageable toxicity.
663630|NCT02108288|B4|Baseline|Total|Total of all reporting groups
663631|NCT02108288|B3|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
663632|NCT02108288|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
663633|NCT02108288|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
663634|NCT02108288|P3|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
663635|NCT02108288|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
663636|NCT02108288|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
663637|NCT02108288|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
663638|NCT02108288|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
663649|NCT02107196|B2|Baseline|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
663650|NCT02107196|B1|Baseline|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663651|NCT02107196|P2|Participant Flow|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the placebo arm will be mock-re-randomized (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
663652|NCT02107196|P1|Participant Flow|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomized to the ibodutant 10 mg arm will be re-randomized at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663653|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663654|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
663655|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663656|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
663657|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663658|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
663659|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663660|NCT02107196|O2|Outcome|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
663661|NCT02107196|O1|Outcome|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663662|NCT02107196|E2|Reported Event|Placebo|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the placebo arm will be mock-re-randomised (switch in blinded conditions) to ibodutant at week 13 for additional 4 weeks of treatment.~Placebo: Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily."
663663|NCT02107196|E1|Reported Event|Ibodutant 10 mg|"Oral tablet to be given once daily for 12 weeks of treatment. Patients randomised to the ibodutant 10 mg arm will be re-randomised at week 13 in a 1:1 ratio to either ibodutant 10 mg or placebo for additional 4 weeks of treatment.~Ibodutant 10 mg: Oral tablet, to be given once daily."
663664|NCT02108223|B4|Baseline|Total|Total of all reporting groups
663665|NCT02108223|B3|Baseline|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663666|NCT02108223|B2|Baseline|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663667|NCT02108223|B1|Baseline|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663668|NCT02108223|P3|Participant Flow|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663669|NCT02108223|P2|Participant Flow|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663670|NCT02108223|P1|Participant Flow|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663671|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663672|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663673|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663674|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663675|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663676|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663677|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663678|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663679|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663680|NCT02108223|O3|Outcome|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663681|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663682|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663683|NCT02108223|O3|Outcome|r-FSH (Gonal-f) Group 3|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663684|NCT02108223|O2|Outcome|r-LH Supplementation to r-FSH Group 2|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663685|NCT02108223|O1|Outcome|Fix Dose r-FSH (Gonal-f) Group 1|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663686|NCT02108223|E3|Reported Event|r-FSH (Gonal-f)|"Group 3: Daily 75 IU/L r-FSH was added to r-FSH treatment until the end of ovarian stimulation.~r-FSH (Gonal-f): recombinant follicle stimulation hormone"
663687|NCT02108223|E2|Reported Event|r-LH Supplementation to r-FSH|"On day 7 of the stimulation, if at least six follicles between 6-10mm were present but there was no follicle over 10 mm on transvaginal ultrasound, E2 level was under 180 pg/ml, it has been considered that the patients had suboptimal response to the stimulation and were divided into Group 2. Group 2 received supplemental r-LH ( Lutropin alpha; Luveris, Merck Serono, France), 75IU/day to r-FSH (Gonal-f) treatment.~r-LH supplementation: recombinant luteinizing hormone"
663688|NCT02108223|E1|Reported Event|Fix Dose r-FSH (Gonal-f)|"The patients who had normal ovarian response were included as the control group (Group 1). The dose of r-FSH (Gonal-f) was continued for the fix dose until the day of hCG in Group 1~fix dose r-FSH (Gonal-f): recombinant follicle stimulation"
663689|NCT02108171|B3|Baseline|Total|Total of all reporting groups
663690|NCT02108171|B2|Baseline|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663691|NCT02108171|B1|Baseline|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663692|NCT02108171|P2|Participant Flow|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663693|NCT02108171|P1|Participant Flow|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
664223|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
663695|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663696|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663697|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663698|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663699|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663700|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663701|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663702|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663703|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663704|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663705|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663706|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663707|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663708|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663709|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663710|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663711|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663712|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663713|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663714|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663715|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663716|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663717|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663718|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663719|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663720|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663721|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663722|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663723|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
688049|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
663754|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663724|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663725|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663726|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663727|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663728|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663729|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663730|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663731|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663732|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663733|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663734|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663735|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663736|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663737|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663738|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663739|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663740|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663741|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663742|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663743|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663744|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663745|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663746|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663747|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663748|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663749|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663750|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663751|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663752|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663753|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
688050|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
663755|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663756|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663757|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663758|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663759|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663760|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663761|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663762|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663763|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663764|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663765|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663766|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663767|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663768|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663769|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663770|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663771|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663772|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663773|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663774|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663775|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663776|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663777|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663778|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663779|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663780|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663781|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663782|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663783|NCT02108171|O1|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
688051|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
663784|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663785|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663786|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663787|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663788|NCT02108171|O2|Outcome|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663789|NCT02108171|O1|Outcome|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663790|NCT02108171|E2|Reported Event|Placebo|"intranasal saline~placebo: 0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663791|NCT02108171|E1|Reported Event|Dexmedetomidine|"intranasal dexmedetomidine~Dexmedetomidine: intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia."
663792|NCT02107898|B3|Baseline|Total|Total of all reporting groups
663793|NCT02107898|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663794|NCT02107898|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663795|NCT02107898|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to Japan Atherosclerosis Society (JAS) Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663796|NCT02107898|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) added to stable lipid-modifying therapy (LMT) for 52 weeks.
663797|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663798|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663799|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663800|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663801|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663802|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663803|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663804|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663805|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663806|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663807|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663808|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663809|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663810|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663811|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663812|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663868|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663869|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663813|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663814|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663815|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663816|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663817|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663818|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663819|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663820|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663821|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663822|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663823|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663824|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663825|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663826|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663827|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663828|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663829|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663830|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663831|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663832|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663833|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663834|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663835|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663836|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663837|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663838|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663839|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663840|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663841|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663842|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663843|NCT02107898|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 100 mg/dL (2.59 mmol/L) or ≥ 120 mg/dL (3.10 mmol/L) at Week 8 according to JAS Guidelines for Prevention of Atherosclerotic Cardiovascular Diseases 2012.
663844|NCT02107898|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
663845|NCT02107898|E2|Reported Event|Alirocumab 75 mg/ Up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
663846|NCT02107898|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 50 weeks).
663847|NCT02107599|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
663848|NCT02107599|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
663849|NCT02107599|O3|Outcome|Non-autopsy Cases|Only 50 non-autopsy scans from A17.
663850|NCT02107599|O2|Outcome|Autopsy Cases|Only 46 autopsy scans from A16.
663851|NCT02107599|O1|Outcome|All Study Cases|All 96 scans from A16 and A17.
663852|NCT02107599|O1|Outcome|Physician Readers|All 21 physician readers.
663853|NCT02107599|E1|Reported Event|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17).
663854|NCT02107482|B1|Baseline|All Participants - Levia Narrow Band UVB|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
663855|NCT02107482|P1|Participant Flow|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
663856|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
663857|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
663858|NCT02107482|O1|Outcome|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
663859|NCT02107482|E1|Reported Event|All Participants|Each subject will have a targeted lesion treated with Levia Narrow Band UVB( skin type I: starting dose of 195 mj/cm2, skin type II: starting dose of 330 mj/cm2, skin type III: starting dose of 390 mj/cm2, skin type IV: starting dose of 495 mj/cm2, skin type V: starting dose of 525 mj/cm2, skin type VI: starting dose of 600 mj/cm2). The dose will be increased by 15% with each treatment, as long as there are no side effects with treatment such as burning or redness. The same subject will have a second target lesion treated with the Sham Comparator.
663860|NCT02107339|B3|Baseline|Total|Total of all reporting groups
663861|NCT02107339|B2|Baseline|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663862|NCT02107339|B1|Baseline|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663863|NCT02107339|P2|Participant Flow|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663864|NCT02107339|P1|Participant Flow|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663865|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663866|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663867|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663870|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663871|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663872|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663873|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663874|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663875|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663876|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663877|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663878|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663879|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663880|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663881|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663882|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663883|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663884|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663885|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663886|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663887|NCT02107339|O2|Outcome|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663888|NCT02107339|O1|Outcome|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663889|NCT02107339|E2|Reported Event|Hydromorphone Group|"Patients will receive hydromorphone 2 mg at the end of the surgical procedure~Hydromorphone: Hydromorphone 2 mg administered at the conclusion of anesthesia"
663890|NCT02107339|E1|Reported Event|Methadone Group|"Patient will receive methadone 0.2 mg/kg at induction of anesthesia (single dose)~Methadone: Methadone 0.2 mg/kg administered at induction of anesthesia"
663891|NCT02107313|B1|Baseline|All Study Participants|Participants are first administered PBT2 250 mg orally following a period of fasting for 10 hours and a high fat breakfast in the FED cohort. Participants then cross over into the FASTED Cohort and receive PBT2 250 mg orally after a period of fasting of 10 hours and without food.
663892|NCT02107313|P2|Participant Flow|Fasted Cohort First Then Fed Cohort|"Per sequence, FASTED Cohort first, then FED Cohort.~Nine participants in the Fasted Cohort. PBT2 250 mg is administered orally following a 10 hour period of fasting and without food first. Participants then cross over into the FED Cohort."
663893|NCT02107313|P1|Participant Flow|Fed Cohort First Then Fasted Cohort|"Per sequence, FED Cohort first then FASTED Cohort.~Nine participants in the FED Cohort. PBT2 250 mg is administered orally following a high fat breakfast first, following a period of fasting for 10 hours and a high fat breakfast. Participants then cross over into the FASTED Cohort."
663894|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
663895|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
663896|NCT02107313|O2|Outcome|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
663897|NCT02107313|O1|Outcome|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
663898|NCT02107313|E2|Reported Event|Fasted Cohort|"PBT2 250 mg is administered orally following a 10 hour period of fasting~Fasted Cohort PBT2: PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food. Participants cross over to the FED cohort after completing the Fasted Cohort."
664023|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
664351|NCT02105012|O1|Outcome|BD MDI 320 µg|Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg
664352|NCT02105012|O5|Outcome|Placebo MDI|Placebo MDI.
663899|NCT02107313|E1|Reported Event|Fed Cohort|"PBT2 250 mg is administered orally following a high fat breakfast~Fed Cohort PBT2: PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast. Participants cross over to the FASTED cohort after completing the Fed Cohort."
663900|NCT02107274|B3|Baseline|Total|Total of all reporting groups
663901|NCT02107274|B2|Baseline|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663902|NCT02107274|B1|Baseline|Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663903|NCT02107274|P2|Participant Flow|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663904|NCT02107274|P1|Participant Flow|Azithromycin and Placebo for Azithromycin|Patients randomised to the treatment arm received 1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663905|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663906|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663907|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663908|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663909|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663910|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663911|NCT02107274|O2|Outcome|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663912|NCT02107274|O1|Outcome|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663913|NCT02107274|E2|Reported Event|Placebo for Azithromycin|Patients randomised to the control arm received placebo for azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663914|NCT02107274|E1|Reported Event|Azithromycin|Patients randomised to the treatment arm received1000mg of azithromycin once a week for 12 weeks followed by placebo for azithromycin once a week for another 12 weeks.
663915|NCT02107014|B1|Baseline|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663916|NCT02107014|P1|Participant Flow|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663917|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663918|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663919|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663920|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663921|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663922|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
664225|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
663923|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663924|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663925|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663926|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663927|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663928|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663929|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663930|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663931|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663932|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663933|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663934|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663935|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663936|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663937|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663938|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
664024|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
663939|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663940|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663941|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663942|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663943|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663944|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663945|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663946|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663947|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663948|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663949|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663950|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663951|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663952|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663953|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663954|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
664025|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
663955|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663956|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663957|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663958|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663959|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663960|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663961|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663962|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663963|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663964|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663965|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663966|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663967|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663968|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663969|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663970|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
664026|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
663971|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663972|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663973|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663974|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663975|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663976|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663977|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663978|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663979|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663980|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663981|NCT02107014|O1|Outcome|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663982|NCT02107014|E1|Reported Event|Low Dose Naltrexone (LDN)|"Following a two-week baseline the study drug was administered daily for 8 weeks. Participants were informed that placebo or LDN would be provided during the drug period and that all participants would receive LDN at some point during the study. In fact, all participants received the active LDN (4.5 mg nocte) throughout the drug-administration period.~Low Dose Naltrexone: Naltrexone 4.5 mg p.o. nocte"
663983|NCT02106923|B4|Baseline|Total|Total of all reporting groups
663984|NCT02106923|B3|Baseline|1500mg, Fasted|Patients orally administered either 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h
663985|NCT02106923|B2|Baseline|1000mg, Fed|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal
663986|NCT02106923|B1|Baseline|1000mg, Fasted|Patients orally administered either 1 x 10 mg Empagliflozin/1000 mg metformin (Met) XR FDC or 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
663987|NCT02106923|P6|Participant Flow|Empa+1500mg Glumetza / Empa+1500mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR followed by oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
663988|NCT02106923|P5|Participant Flow|Empa+1500mg Met FDC / Empa+1500mg Glumetza (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
663989|NCT02106923|P4|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
688052|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
663990|NCT02106923|P3|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after a high-fat, high-caloric meal.
663991|NCT02106923|P2|Participant Flow|Empa+1000mg Glumetza / Empa+1000mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR followed by oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR FDC. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 h.
663992|NCT02106923|P1|Participant Flow|Empa+1000mg Met FDC / Empa+1000mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin (Empa)/1000 mg metformin (Met) extended release (XR) fixed dose combination (FDC) followed by oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR. Both treatments were taken with 240 mL of water after an overnight fast of at least 10 hours (h).
663993|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
663994|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
663995|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
663996|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
663997|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
663998|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
663999|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
664000|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664001|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
664002|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
664003|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
664004|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664005|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
664006|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664007|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
664008|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
664009|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
664010|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664011|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
664012|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664013|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
664014|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
664015|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
664016|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664017|NCT02106923|O6|Outcome|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
664018|NCT02106923|O5|Outcome|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664019|NCT02106923|O4|Outcome|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
664020|NCT02106923|O3|Outcome|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
664021|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
664022|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664027|NCT02106923|O2|Outcome|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
664028|NCT02106923|O1|Outcome|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664029|NCT02106923|E6|Reported Event|Empa/ 1500 mg Met FDC (Fasted)|Oral administration of 2 x 5 mg Empagliflozin/750 mg Metformin XR FDC with 240 mL of water after an overnight fast of at least 10 h
664030|NCT02106923|E5|Reported Event|Empa/ 1500 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 3 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664031|NCT02106923|E4|Reported Event|Empa/ 1000 mg Met FDC (Fed)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg Metformin XR FDC with 240 mL of water after a high-fat, high-caloric meal
664032|NCT02106923|E3|Reported Event|Empa/1000 mg Glumetza ® (Fed)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after a high-fat, high-caloric meal
664033|NCT02106923|E2|Reported Event|Empa/ 1000 mg Met FDC (Fasted)|Oral administration of 1 x 10 mg Empagliflozin/1000 mg metformin XR fixed dose combination (FDC) with 240 mL of water after an overnight fast of at least 10 h
664034|NCT02106923|E1|Reported Event|Empa/1000 mg Glumetza® (Fasted)|Oral administration of 1 x 10 mg Empagliflozin + 2 x 500 mg Glumetza® XR with 240 mL of water after an overnight fast of at least 10 h
664035|NCT02106728|B3|Baseline|Total|Total of all reporting groups
664036|NCT02106728|B2|Baseline|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664037|NCT02106728|B1|Baseline|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664038|NCT02106728|P2|Participant Flow|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664039|NCT02106728|P1|Participant Flow|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664040|NCT02106728|O6|Outcome|Supportive Family Therapy (Approximately 10 WEEKS)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664041|NCT02106728|O5|Outcome|Multi-Family Therapy (8WEEKS)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664042|NCT02106728|O4|Outcome|Supportive Family Therapy (POST)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664043|NCT02106728|O3|Outcome|Multi-Family Therapy (POST)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664044|NCT02106728|O2|Outcome|Supportive Family Therapy (PRE)|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664064|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664323|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664045|NCT02106728|O1|Outcome|Multi-Family Therapy (PRE)|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664046|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664047|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664048|NCT02106728|O2|Outcome|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664049|NCT02106728|O1|Outcome|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664050|NCT02106728|E2|Reported Event|Supportive Family Therapy|"Family supportive counseling consists of people with eating disorders and their family members meeting with a family therapist. This is treatment as usual in the Eating Disorders Program at University Health Network.~Supportive Family Therapy: Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family."
664051|NCT02106728|E1|Reported Event|Multi-Family Therapy|"Multi-family group therapy involving eight to ten families who meet as a group with two therapists for a duration of 8, 1.5h sessions.~Multi-Family Therapy: Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention."
664052|NCT02106494|B3|Baseline|Total|Total of all reporting groups
664053|NCT02106494|B2|Baseline|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
664054|NCT02106494|B1|Baseline|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
664055|NCT02106494|P2|Participant Flow|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664056|NCT02106494|P1|Participant Flow|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664057|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664058|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664059|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664060|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664061|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664062|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for Ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664063|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 – Dexamethasone 8 mg PO QD~Days 3 and 4 – Dexamethasone 8 mg PO BID"
664324|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664065|NCT02106494|O2|Outcome|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC + Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
664066|NCT02106494|O1|Outcome|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
664067|NCT02106494|E2|Reported Event|Ondansetron + Fosaprepitant + Dexamethasone|"Day 1 - Single IV dose of Ondansetron 0.15 mg/kg (up to a maximum of 16 mg) + Placebo for APF530 SC+ Fosaprepitant 150 mg IV + Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
664068|NCT02106494|E1|Reported Event|APF530 + Fosaprepitant + Dexamethasone|"Day 1 - Single SC dose of APF530 500 mg (10 mg granisetron) + Placebo for ondansetron IV+ Fosaprepitant 150 mg IV+ Dexamethasone 12 mg IV~Day 2 - Dexamethasone 8 mg PO QD~Days 3 and 4 - Dexamethasone 8 mg PO BID"
664069|NCT02106403|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics
664070|NCT02106403|P6|Participant Flow|Sequence 6|Negative control was sprayed twice on the first wound, followed by Reference product sprayed twice on the second wound and Prototype Disinfectant Spray twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
664071|NCT02106403|P5|Participant Flow|Sequence 5|Negative control was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Reference product sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
664072|NCT02106403|P4|Participant Flow|Sequence 4|Reference product was sprayed twice on the first wound, followed by Negative control sprayed twice on the second wound and subsequently prototype disinfectant spray was twice sprayed on the third wound. At least 30 min interval was allowed between prior and next product application.
664073|NCT02106403|P3|Participant Flow|Sequence 3|Reference product was sprayed twice on the first wound, followed by Prototype Disinfectant Spray twice sprayed on the second wound and Negative control sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
664074|NCT02106403|P2|Participant Flow|Sequence 2|Prototype disinfectant spray was sprayed twice on first wound, followed by Negative control sprayed twice on the second wound and subsequently Reference product was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
664075|NCT02106403|P1|Participant Flow|Sequence 1|Prototype disinfectant spray was sprayed twice on first wound, followed by Reference product twice sprayed on the second wound and subsequently Negative control was sprayed twice on the third wound. At least 30 min interval was allowed between prior and next product application.
664076|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664077|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664078|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664079|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664080|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664081|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664082|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664083|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664084|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound
664085|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664086|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664087|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664088|NCT02106403|O3|Outcome|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664089|NCT02106403|O2|Outcome|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664090|NCT02106403|O1|Outcome|Prototype Disinfectant Spray Formulation|0.13% w/w Benzalkonium Chloride (BAC) and 1% Menthone Glycerin Acetal (MGA). After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664091|NCT02106403|E3|Reported Event|Negative Control|0.9% w/v Sodium Chloride solution. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664092|NCT02106403|E2|Reported Event|Reference Product|0.13% w/w BAC. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664093|NCT02106403|E1|Reported Event|Prototype Disinfectant Spray Formulation|0.13% w/w BAC and 1% MGA. After wounding, the product was held approximately 10 cm above the wounded area, and sprayed twice towards the wound.
664094|NCT02106156|B4|Baseline|Total|Total of all reporting groups
664325|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664326|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664095|NCT02106156|B3|Baseline|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
664096|NCT02106156|B2|Baseline|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664097|NCT02106156|B1|Baseline|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664098|NCT02106156|P3|Participant Flow|Elastography Analysis Set: Untreated|The untreated elastography analysis set includes those participants with CHC, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
664099|NCT02106156|P2|Participant Flow|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with hepatitis C virus (HCV) treatment as indicated.
664100|NCT02106156|P1|Participant Flow|Main Analysis Set|Participants with chronic hepatitis C (CHC) treated with pegylated interferon (peginterferon) alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding summary of product characteristics (SmPC).
664101|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664102|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664103|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664104|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664105|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664106|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664107|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664108|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664109|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664110|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664111|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664112|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664113|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664114|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664327|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
688053|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
664115|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664116|NCT02106156|O2|Outcome|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those who were treated with HCV treatment as indicated.
664117|NCT02106156|O1|Outcome|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664118|NCT02106156|E3|Reported Event|Elastography Analysis Set: Untreated|Participants with CHC in the untreated elastography analysis set includes those participants, who underwent elastography, were documented in the fibroscan module and were not treated with HCV treatment.
664119|NCT02106156|E2|Reported Event|Elastography Analysis Set: Treated|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. The elastography analysis set includes participants, who underwent elastography and were documented in the fibroscan module. The treated set included those, who were treated with HCV treatment as indicated.
664120|NCT02106156|E1|Reported Event|Main Analysis Set|Participants with CHC treated with peginterferon alfa-2a monotherapy, or with peginterferon alfa-2a and ribavirin with or without other approved CHC therapy were observed. Treatments were administered according to their corresponding SmPC.
664121|NCT02105987|B3|Baseline|Total|Total of all reporting groups
664122|NCT02105987|B2|Baseline|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664123|NCT02105987|B1|Baseline|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664124|NCT02105987|P6|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
664125|NCT02105987|P5|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch:Cont Phase|If ABC/DTG/3TC was not locally approved and commercially available when a participant successfully completed the Week 48 visit, the participant had the opportunity to enter into the Continuation Phase. During the Continuation Phase, participants were supplied with ABC/DTG/3TC until it was locally approved and commercially available.
664126|NCT02105987|P4|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Late Switch|Participants who completed early switch phase and maintained viral suppression (<50 Copies per milliliter [c/mL]) were switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664127|NCT02105987|P3|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC Early Switch|Participants who completed early switch phase continued to receive ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for an additional 24 weeks.
664128|NCT02105987|P2|Participant Flow|Current ART|Participants continued on their current ART regimen for 24 weeks.
664129|NCT02105987|P1|Participant Flow|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received abacavir (ABC) 600 milligrams (mg)/ dolutegravir (DTG) 50 mg/ lamivudine (3TC) 300 mg fixed-dose combination (FDC) tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks.
664130|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664131|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664132|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664133|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664134|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664135|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664136|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664137|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664138|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664139|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664140|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664141|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664142|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664143|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664144|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664145|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664146|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664147|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664148|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664149|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664150|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664151|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664152|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664153|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664154|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664155|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664156|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664157|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664158|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664159|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664224|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
664160|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664161|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664162|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664163|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664164|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664165|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664166|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664167|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664168|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664169|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664170|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664171|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664172|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664173|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664174|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664175|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664176|NCT02105987|O2|Outcome|Current ART|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664177|NCT02105987|O1|Outcome|ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664178|NCT02105987|E2|Reported Event|Late Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants continued on their current ART regimen for 24 weeks. At Week 24, participants originally randomly assigned to continue their current regimen switched to ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets and were followed for an additional 24 weeks of treatment.
664179|NCT02105987|E1|Reported Event|Early Switch ABC 600 mg / DTG 50 mg /3TC 300 mg FDC|Participants received ABC 600 mg/DTG 50 mg/3TC 300 mg FDC tablets with or without food once daily in the morning or the evening at approximately the same time each day for 24 weeks. At Week 24, participants will continue on this treatment for an additional 24 weeks.
664180|NCT02105974|B3|Baseline|Total|Total of all reporting groups
664181|NCT02105974|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664198|NCT02105740|P1|Participant Flow|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression."
664182|NCT02105974|B1|Baseline|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664183|NCT02105974|P3|Participant Flow|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664184|NCT02105974|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler [MDI] or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664185|NCT02105974|P1|Participant Flow|Placebo Run-In|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
664186|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664187|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664188|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664189|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664190|NCT02105974|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664191|NCT02105974|O1|Outcome|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664192|NCT02105974|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD via a DPI in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664193|NCT02105974|E1|Reported Event|FF/VI 100/25 µg QD|Participants received fluticasone furoate/vilaterol (FF/VI) 100/25 microgram(µg) inhalation via a dry powder inhaler (DPI) once daily (QD) in the morning for 12 weeks. In addition, all participants were provided with albuterol (salbutamol) or oxitropium bromide (applicable sites in Japan) to be used as rescue medication (via metered-dose inhaler (MDI) or nebules) for relief of COPD symptoms during the Run-In and Treatment Periods.
664194|NCT02105740|B3|Baseline|Total|Total of all reporting groups
664195|NCT02105740|B2|Baseline|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.~Control : The control and experimental groups respond in 3 different moments to Visual Analog Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting was made before the hypnosis. In the second meeting, within an interval of 7 days, the scales were applied in all patients. Before applying the scales, the hypnosis group was submitted to the session. The third meeting occurred two weeks later, where the scales were only applied to compare the groups."
664196|NCT02105740|B1|Baseline|Hypnosis|"Use of hypnosis to reduct the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two sessions of 40-minute, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
664197|NCT02105740|P2|Participant Flow|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain, anxiety and depression with the application of the scales.~Control x Hypnosis Group: The control and hypnosis groups respond in 3 different distinct moments, with the Visual Analogue Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group, after the follow-up visit. The third evaluation will occur two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety."
664328|NCT02105272|E2|Reported Event|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664199|NCT02105740|O2|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding anxiety and depression with the application of the Hospital Anxiety and Depression Scale (HADS).~Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Hospital Anxiety and Depression Scale (HADS) to evaluate depression and anxiety. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group was compared in relation to the intensity of the depression and anxiety"
664200|NCT02105740|O1|Outcome|Hypnosis|"Use of hypnosis in the reduction of the levels depression and anxiety.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
664201|NCT02105740|O2|Outcome|Control|"Comparison of the effects of hypnosis between the control group and the hypnosis group regarding pain with the application of the Visual Analogue Scale (VAS).~Control x Hypnosis Group: The control and the hypnosis groups respond in 3 different distinct moments, using the Visual Analogue Scale (VAS) to evaluate the pain. The first evaluation was made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation was made two weeks later, in order to provide a follow-up to assess the efficacy of the technique."
664202|NCT02105740|O1|Outcome|Hypnosis|"Use of hypnosis to change the levels of pain.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms."
664203|NCT02105740|E2|Reported Event|Control|"Comparison of the effects of hypnosis between the control group and the experimental group regarding pain, anxiety and depression with the application of the scales.~Control x Experimental Group: The control and experimental groups respond in 3 different distinct moments, with the Visual Analog Scale (VAS) for the evaluation of pain, and the Hospital Anxiety and Depression Scale (HADS) to evaluate the depression and the anxiety. The first evaluation will be made before the research. The second within an interval of 7 days, so being that in the experimental group the same will happen after the hypnosis session and in the control group after the follow-up visit. The third evaluation will be two weeks later, in order to provide a follow-up to assess the efficacy of the technique. The experimental group and the control group will be compared in relation to the intensity of the pain, depression and anxiety"
664204|NCT02105740|E1|Reported Event|Hypnosis|"Use of hypnosis in the reduction of the levels of pain, depression and anxiety.~Hypnosis: The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same."
664205|NCT02105701|B5|Baseline|Total|Total of all reporting groups
664206|NCT02105701|B4|Baseline|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
664207|NCT02105701|B3|Baseline|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
664208|NCT02105701|B2|Baseline|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
664209|NCT02105701|B1|Baseline|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
664210|NCT02105701|P4|Participant Flow|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
664211|NCT02105701|P3|Participant Flow|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
664212|NCT02105701|P2|Participant Flow|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
664213|NCT02105701|P1|Participant Flow|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
664214|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
664215|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
664216|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
664217|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
664218|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
664219|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
664220|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
664221|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
664222|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
688054|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
664226|NCT02105701|O4|Outcome|Grazoprevir + Elbasvir + RBV 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
664227|NCT02105701|O3|Outcome|Grazoprevir + Elbasvir 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
664228|NCT02105701|O2|Outcome|Grazoprevir + Elbasvir + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
664229|NCT02105701|O1|Outcome|Grazoprevir + Elbasvir 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
664230|NCT02105701|E4|Reported Event|GZR/EBR + RBV for 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 16 weeks.
664231|NCT02105701|E3|Reported Event|GZR/EBR 16 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 16 weeks.
664232|NCT02105701|E2|Reported Event|GZR/EBR + RBV 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth, along with RBV capsules b.i.d. by mouth (weight-based dosing; 800 to 1400 mg total daily dose), for 12 weeks.
664233|NCT02105701|E1|Reported Event|GZR/EBR 12 Weeks|Participants received grazoprevir 100 mg/elbasvir 50 mg FDC tablets q.d. by mouth for 12 weeks.
664234|NCT02105688|B3|Baseline|Total|Total of all reporting groups
664235|NCT02105688|B2|Baseline|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
664236|NCT02105688|B1|Baseline|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
664237|NCT02105688|P2|Participant Flow|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
664238|NCT02105688|P1|Participant Flow|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
664239|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
664240|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
664241|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
664242|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
664243|NCT02105688|O2|Outcome|Deferred Treatment Arm|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up. Afterwards, participants receive 12 weeks of open-label treatment with the MK-5172A FDC and are followed-up for 24 weeks.
664244|NCT02105688|O1|Outcome|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
664245|NCT02105688|E2|Reported Event|Deferred Treatment Arm (Placebo)|In Part A, participants receive placebo to MK-5172A once daily for 12 weeks (blinded), followed by 4 weeks of follow-up.
664246|NCT02105688|E1|Reported Event|Immediate Treatment Arm|In Part A, participants receive grazoprevir 100 mg plus elbasvir 50 mg FDC (MK-5172A) once daily for 12 weeks (blinded) and are followed-up for 24 weeks.
664247|NCT02105662|B1|Baseline|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
664248|NCT02105662|P1|Participant Flow|Grazoprevir+Elbasvir|Participants received a fixed-dose combination (FDC) of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
664249|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
664250|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
664251|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
664252|NCT02105662|O1|Outcome|Grazoprevir+Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
664253|NCT02105662|E1|Reported Event|Grazoprevir + Elbasvir|Participants received a FDC of grazoprevir 100 mg plus elbasvir 50 mg once daily for 12 weeks and were followed-up for 24 weeks.
664254|NCT02105636|B3|Baseline|Total|Total of all reporting groups
664255|NCT02105636|B2|Baseline|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
664256|NCT02105636|B1|Baseline|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
664329|NCT02105272|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664330|NCT02105012|B1|Baseline|All Subjects|
664257|NCT02105636|P2|Participant Flow|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
664258|NCT02105636|P1|Participant Flow|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
664259|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigator's Choice.
664260|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
664261|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
664262|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
664263|NCT02105636|O2|Outcome|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
664264|NCT02105636|O1|Outcome|Nivolumab 3mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
664265|NCT02105636|E2|Reported Event|Cetuximab/Methotrexate/Docetaxel|Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligram/meter squared (mg/m2) for the first dose followed that a doses of 250 mg/m2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice.
664266|NCT02105636|E1|Reported Event|Nivolumab 3 mg/kg|Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression.
664267|NCT02105467|B3|Baseline|Total|Total of all reporting groups
664268|NCT02105467|B2|Baseline|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
664269|NCT02105467|B1|Baseline|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
664270|NCT02105467|P2|Participant Flow|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks (Period 1), followed by a 4-week unblinding/washout period and 12 weeks of open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily (Period 2), followed by a 24-week follow-up period (Period 3).
664271|NCT02105467|P1|Participant Flow|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks (Period 1), followed by a 24-week follow-up period (Period 2)
664272|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
664273|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
664274|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
664275|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
664276|NCT02105467|O2|Outcome|Deferred Treatment Group|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks.
664277|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
664278|NCT02105467|O1|Outcome|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period
664279|NCT02105467|E3|Reported Event|Deferred Treatment Group (Open-label Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Week 16 through Week 52.
664280|NCT02105467|E2|Reported Event|Deferred Treatment Group (Blinded Treatment)|Participants received blinded placebo tablet orally once daily for 12 weeks; after a 4-week unblinding/washout period participants received open label grazoprevir 100 mg / elbasvir 50 mg FDC tablet orally once daily for 12 weeks. Follow-up was for an additional 24 weeks. Adverse event reporting covers Day 1 through Week 16.
664281|NCT02105467|E1|Reported Event|Immediate Treatment Group|Participants received blinded grazoprevir 100 mg / elbasvir 50 mg fixed-dose combination (FDC) tablet orally once daily for 12 weeks followed by a 24-week follow-up period. Adverse event reporting covers Day 1 through Week 36.
664282|NCT02105454|B1|Baseline|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
664283|NCT02105454|P1|Participant Flow|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
664284|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
664285|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
664286|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
664287|NCT02105454|O1|Outcome|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
664288|NCT02105454|E1|Reported Event|GZR 100 mg + EBR 50 mg + RBV for 12 Weeks|Participants receive grazoprevir 100 mg once per day (QD), elbasvir 50 mg QD, and RBV 800 - 1400 mg total daily dose divided twice per day (based on body weight) for 12 weeks
664289|NCT02105285|B4|Baseline|Total|Total of all reporting groups
664290|NCT02105285|B3|Baseline|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
664291|NCT02105285|B2|Baseline|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664292|NCT02105285|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664293|NCT02105285|P3|Participant Flow|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
664294|NCT02105285|P2|Participant Flow|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664295|NCT02105285|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664296|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664297|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664298|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664299|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664300|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664301|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664302|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664303|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664304|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664305|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664306|NCT02105285|O2|Outcome|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664307|NCT02105285|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664308|NCT02105285|E3|Reported Event|Carteolol and Latanoprost Ophthalmic Solution|"Once daily~Carteolol ophthalmic solution and Latanoprost ophthalmic solution"
664309|NCT02105285|E2|Reported Event|Carteolol Long-acting Ophthalmic Solution|"Once daily~Carteolol long-acting ophthalmic solution"
664310|NCT02105285|E1|Reported Event|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664311|NCT02105272|B3|Baseline|Total|Total of all reporting groups
664312|NCT02105272|B2|Baseline|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664313|NCT02105272|B1|Baseline|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664314|NCT02105272|P2|Participant Flow|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664315|NCT02105272|P1|Participant Flow|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664316|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664317|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664318|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664319|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664320|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664321|NCT02105272|O1|Outcome|OPC-1085EL Ophthalmic Solution|"Once daily~OPC-1085EL ophthalmic solution"
664322|NCT02105272|O2|Outcome|Latanoprost Ophthalmic Solution|"Once daily~Latanoprost ophthalmic solution"
664331|NCT02105012|P1|Participant Flow|All Subjects|
664363|NCT02104895|B2|Baseline|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
664364|NCT02104895|B1|Baseline|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
664365|NCT02104895|P2|Participant Flow|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
664366|NCT02104895|P1|Participant Flow|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
664367|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
664368|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
664369|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
664370|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
664371|NCT02104895|O2|Outcome|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
664372|NCT02104895|O1|Outcome|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
664373|NCT02104895|E2|Reported Event|Partial Breast Irradiation (APBI)|"Accelerated partial breast irradiation (APBI)~Accelerated partial breast irradiation (APBI): Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)"
664374|NCT02104895|E1|Reported Event|Whole Breast Irradiation (WBI)|"Conventional whole breast irradiation (WBI)~Whole breast irradiation (WBI): Conventional whole breast irradiation (WBI)"
664375|NCT02104830|B4|Baseline|Total|Total of all reporting groups
664376|NCT02104830|B3|Baseline|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy and placebo #1 in dose 1.0 ml ubcutaneously, 24 h after the chemotherapy.~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664377|NCT02104830|B2|Baseline|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.~empegfilrastim 7.5 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml.~Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg."
664378|NCT02104830|B1|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy and placebo #2 in a dose of 0.0083 ml/kg in 24-27 hour after chemotherapy, then patient received placebo #2 in dose 0.0083 ml/kg until ANC ≥ 10x109/L or during 14 days~empegfilrastim 6 mg: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664379|NCT02104830|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664380|NCT02104830|P2|Participant Flow|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664381|NCT02104830|P1|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664528|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
664382|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664383|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664384|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664535|NCT02102932|E5|Reported Event|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
664385|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664386|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664387|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664388|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664389|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664390|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664391|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664392|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664393|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664394|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664395|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664396|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664397|NCT02104830|O3|Outcome|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664398|NCT02104830|O2|Outcome|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664399|NCT02104830|O1|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664400|NCT02104830|E3|Reported Event|Filgrastim|"Patients will receive filgrastim at a dose of 5 μg/kg subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~Placebo №1: Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0."
664401|NCT02104830|E2|Reported Event|Empegfilgrastim 7.5 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 7.5 mg subcutaneously, 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664402|NCT02104830|E1|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously , 24 h after the chemotherapy~Placebo №2: Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg."
664403|NCT02104219|B1|Baseline|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
664404|NCT02104219|P1|Participant Flow|Retrospective Observational|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
664405|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
665570|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
664406|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
664407|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
664408|NCT02104219|O1|Outcome|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
664409|NCT02104219|E1|Reported Event|Patients Diagnosed With Juvenile-onset HPP|Patients diagnosed with juvenile-onset HPP (ie, documented onset of first signs/symptoms of HPP at ≥ 6 months to < 18 years of age).
664410|NCT02103439|B3|Baseline|Total|Total of all reporting groups
664411|NCT02103439|B2|Baseline|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664412|NCT02103439|B1|Baseline|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664413|NCT02103439|P2|Participant Flow|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664414|NCT02103439|P1|Participant Flow|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664415|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664416|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664417|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664418|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664419|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664420|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664421|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664422|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664423|NCT02103439|O4|Outcome|PegIntron - HCV-2/3|"Patients with HCV genotype 2 or 3, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664453|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664529|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
664424|NCT02103439|O3|Outcome|PegIntron - HCV-1|"Patients with HCV genotype 1, received PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664425|NCT02103439|O2|Outcome|Algeron - HCV-2/3|"Patients with HCV genotype 2 or 3, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664457|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664426|NCT02103439|O1|Outcome|Algeron - HCV-1|"Patients with HCV genotype 1, received Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664427|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664428|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664429|NCT02103439|O2|Outcome|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week"
664430|NCT02103439|O1|Outcome|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664431|NCT02103439|E2|Reported Event|PegIntron|"PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg).~PegIntron: 1.5 µg/kg of body weight subcutaneously, once a week~The safety analysis included 71 patients received at least 1 dose of PegIntron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [previous treatment of hepatitis C with interferon alfa], who was withdrawn from the mITT-analysis)"
664432|NCT02103439|E1|Reported Event|Algeron|"Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight <65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight > 105 kg)~Algeron: 1.5 µg/kg of body weight subcutaneously, once a week"
664433|NCT02103309|B1|Baseline|Overall|DAILIES® AquaComfort Plus® and 1-Day ACUVUE® MOIST® contact lenses worn in a crossover assignment.
664434|NCT02103309|P2|Participant Flow|1DAM, Then DACP|Etafilcon A contact lenses worn first, then nelfilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664435|NCT02103309|P1|Participant Flow|DACP, Then 1DAM|Nelfilcon A contact lenses worn first, then etafilcon A contact lenses worn second. Each product worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664436|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664437|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664438|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664439|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664440|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664441|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664442|NCT02103309|O2|Outcome|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664443|NCT02103309|O1|Outcome|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664444|NCT02103309|E2|Reported Event|1DAM|Etafilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664445|NCT02103309|E1|Reported Event|DACP|Nelfilcon A contact lenses worn bilaterally (in both eyes) for 1 week in a daily disposable mode.
664446|NCT02103062|B3|Baseline|Total|Total of all reporting groups
664447|NCT02103062|B2|Baseline|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664448|NCT02103062|B1|Baseline|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664449|NCT02103062|P2|Participant Flow|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664450|NCT02103062|P1|Participant Flow|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664451|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664452|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664526|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
664454|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664455|NCT02103062|O2|Outcome|RAS Mutated Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664456|NCT02103062|O1|Outcome|RAS Wildtype Abraxane (Nab®-Paclitaxel)|Abraxane (nab®-paclitaxel) 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
665571|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
664458|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664459|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664460|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664461|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664462|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664463|NCT02103062|O2|Outcome|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664464|NCT02103062|O1|Outcome|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664465|NCT02103062|E2|Reported Event|RAS Mutated: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664466|NCT02103062|E1|Reported Event|RAS Wildtype: Nab®-Paclitaxel|nab®-paclitaxel 125 mg/m^2 on days 1, 8 and 15 of every 28 day cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
664467|NCT02102932|B9|Baseline|Total|Total of all reporting groups
664468|NCT02102932|B8|Baseline|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
664469|NCT02102932|B7|Baseline|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
664470|NCT02102932|B6|Baseline|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
664471|NCT02102932|B5|Baseline|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
664472|NCT02102932|B4|Baseline|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
664473|NCT02102932|B3|Baseline|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
664474|NCT02102932|B2|Baseline|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
664475|NCT02102932|B1|Baseline|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
664476|NCT02102932|P8|Participant Flow|R4T4|"Study Part 4:~R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R4 and T4"
664477|NCT02102932|P7|Participant Flow|T4R4|"Study Part 4:~T4: Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin R4: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T4 and R4."
664478|NCT02102932|P6|Participant Flow|R3T3|"Study Part 3:~R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin; A washout period of at least 7 days was to be maintained between R3 and T3"
664479|NCT02102932|P5|Participant Flow|T3R3|"Study Part 3:~T3: Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin R3: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg; A washout period of at least 7 days was to be maintained between T3 and R3."
664480|NCT02102932|P4|Participant Flow|R2T2|"Study part 2:~R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R2 and T2."
664527|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
665557|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
664481|NCT02102932|P3|Participant Flow|T2R2|"Study Part 2:~T2: Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin R2: Oral administration of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T2 and R2."
664482|NCT02102932|P2|Participant Flow|R1T1|"Study Part 1:~R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg T1: Oral administration of a single FDC tablet 12.5 mg empagliflozin/850 mg metformin; A washout period of at least 7 days was to be maintained between R1 and T1."
664534|NCT02102932|E6|Reported Event|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
706658|NCT01812655|E2|Reported Event|Passive Distraction|watching a movie
664483|NCT02102932|P1|Participant Flow|T1R1|"Study Part 1:~T1: Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin R1: Oral administration of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg; A washout period of at least 7 days was to be maintained between T1 and R1."
664484|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
664485|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
664486|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
664487|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
664488|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
664489|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
664490|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
664491|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
664492|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
664493|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
664494|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
664495|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
664496|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
664497|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
664498|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
664499|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
664500|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
664501|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
664502|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
664503|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
664504|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
664505|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
664506|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
664507|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
664508|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
664509|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
664510|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
664511|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
664512|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
664513|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
664514|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
664515|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
664516|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
664517|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
664518|NCT02102932|O6|Outcome|R3 (FC)|Oral administration of FC of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 500 mg
664519|NCT02102932|O5|Outcome|T3 (FDC)|Oral administration of a single FDC tablet 12.5 mg empagliflozin/500 mg metformin
664520|NCT02102932|O4|Outcome|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
664521|NCT02102932|O3|Outcome|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
664522|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
664523|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
664524|NCT02102932|O8|Outcome|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
664525|NCT02102932|O7|Outcome|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
688055|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
664530|NCT02102932|O2|Outcome|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
664531|NCT02102932|O1|Outcome|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
664532|NCT02102932|E8|Reported Event|R4 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 500 mg
664533|NCT02102932|E7|Reported Event|T4 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/500 mg metformin
664536|NCT02102932|E4|Reported Event|R2 (FC)|Oral administration of FC of 1 tablet empagliflozin 5 mg + 1 tablet Glucophage® 850 mg
664537|NCT02102932|E3|Reported Event|T2 (FDC)|Oral administration of a single FDC tablet 5 mg empagliflozin/850 mg metformin
664538|NCT02102932|E2|Reported Event|R1 (FC)|Oral administration of free combination (FC) of 1 tablet empagliflozin 10 mg + 1 tablet empagliflozin 2.5 mg + 1 tablet Glucophage® 850 mg
664539|NCT02102932|E1|Reported Event|T1 (FDC)|Oral administration of a single fixed dose combination (FDC) tablet 12.5 mg empagliflozin/850 mg metformin
664540|NCT02102399|B3|Baseline|Total|Total of all reporting groups
664541|NCT02102399|B2|Baseline|Respiratory Muscle Training|Respiratory Muscle Training group was performed during 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664542|NCT02102399|B1|Baseline|Vocal Warm-up|Vocal Warm up group was performed during 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664543|NCT02102399|P2|Participant Flow|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664544|NCT02102399|P1|Participant Flow|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664545|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664546|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664547|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664548|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664549|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664550|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664551|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
664552|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664553|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
664554|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664555|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
664556|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664557|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
664558|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664559|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
664560|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664561|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day
664562|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664563|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664564|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664565|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
665558|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
664566|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664567|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664568|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664569|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664570|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664571|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664572|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664573|NCT02102399|O2|Outcome|Vocal Warm-up (Posttest)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664574|NCT02102399|O1|Outcome|Vocal Warm-up (Baseline)|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664575|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664576|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664577|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664578|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664579|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664580|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664581|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664582|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664583|NCT02102399|O2|Outcome|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664584|NCT02102399|O1|Outcome|Vocal Warm-up|Vocal Warm up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day
664585|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664586|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664587|NCT02102399|O2|Outcome|Respiratory Muscle Training (Posttest)|Respiratory Muscle Training group performed 13 minutes of respiratory muscle training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664588|NCT02102399|O1|Outcome|Respiratory Muscle Training (Baseline)|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664589|NCT02102399|E2|Reported Event|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
664590|NCT02102399|E1|Reported Event|Vocal Warm-up|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
664591|NCT02101359|B3|Baseline|Total|Total of all reporting groups
664592|NCT02101359|B2|Baseline|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
664593|NCT02101359|B1|Baseline|T2380|T2380: Intracameral administration during surgery
664594|NCT02101359|P2|Participant Flow|Reference Group|Mydriatics and anesthetics: Topical treatments used the day of surgery
664595|NCT02101359|P1|Participant Flow|T2380|T2380: Intracameral administration during surgery
664596|NCT02101359|O2|Outcome|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
664597|NCT02101359|O1|Outcome|T2380|T2380: Intracameral administration during surgery
664598|NCT02101359|E2|Reported Event|Reference Group|Mydriatics and anesthetic: Topical treatments used the day of surgery
664599|NCT02101359|E1|Reported Event|T2380|T2380: Intracameral administration during surgery
664600|NCT02101294|B1|Baseline|Interossei Lumbricals Neuro Interface|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.
665559|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
664637|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
664638|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664639|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
664640|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
664601|NCT02101294|P1|Participant Flow|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
664602|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the FingerRelief keyboard.
664603|NCT02101294|O1|Outcome|Length of Time Typing With FingerRelief|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the FingerRelief keyboard prior to stopping, averaged across two typing sessions.
664604|NCT02101294|O1|Outcome|Measurement of Wrist Swelling Following Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the tape measurement of wrist swelling following typing with the QWERTY keyboard.
664605|NCT02101294|O1|Outcome|Length of Time Typing With QWERTY|Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device. These are the results of the length of time the patients typed with the QWERTY keyboard prior to stopping, averaged across two typing sessions.
664606|NCT02101294|E1|Reported Event|Interossei Lumbricals Neuro Interface|"Comparison of report of symptoms of carpal tunnel syndrome when typing with standard QWERTY keyboard to report of symptoms of carpal tunnel syndrome when typing with Interossei Lumbricals Neuromuscular Technology Interface Therapy device.~Interossei Lumbricals Neuro Interface: Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness."
664607|NCT02101190|B3|Baseline|Total|Total of all reporting groups
664608|NCT02101190|B2|Baseline|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664609|NCT02101190|B1|Baseline|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664610|NCT02101190|P2|Participant Flow|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664611|NCT02101190|P1|Participant Flow|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664612|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664613|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664614|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664615|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664616|NCT02101190|O2|Outcome|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664617|NCT02101190|O1|Outcome|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664618|NCT02101190|E2|Reported Event|Group 2 - Healthy Subjects|"Group 2 - healthy subjects treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664619|NCT02101190|E1|Reported Event|Group 1 - Hepatic Impaired Subjects|"Group 1 - subjects with moderate chronic hepatic impairment treated with BIA 9-1067~BIA 9-1067: Opicapone, OPC"
664620|NCT02101112|B1|Baseline|Apixaban, 10 mg (Whole Tablets)|This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment.
664621|NCT02101112|P6|Participant Flow|Treatment C Then Treatment B Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
688056|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
664622|NCT02101112|P5|Participant Flow|Treatment C Then Treatment A Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
664623|NCT02101112|P4|Participant Flow|Treatment B Then Treatment A Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
664624|NCT02101112|P3|Participant Flow|Treatment B Then Treatment C Then Treatment A|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
664625|NCT02101112|P2|Participant Flow|Treatment A Then Treatment C Then Treatment B|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
664626|NCT02101112|P1|Participant Flow|Treatment A Then Treatment B Then Treatment C|"Treatment A = Apixaban, 10 mg (Whole Tablets); Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.~Treatment B = Apixaban, 10 mg (Crushed and Suspended in Water); Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.~Treatment C = Apixaban, 10 mg (Crushed and Mixed With Applesauce); Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce~This was a 3-period, 3-treatment crossover study. Each participant received (orally) a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and suspended in 30 mL water and a single-dose of apixaban 10 mg (two 5-mg tablets) crushed and mixed with 30 g applesauce according to a randomization schedule. Each participant underwent a washout of at least 4 days before receiving the next scheduled treatment."
664627|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664628|NCT02101112|O1|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
664629|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664630|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
664631|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
664632|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664633|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
664634|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
664635|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664636|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
665560|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
664641|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664642|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
664643|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
664644|NCT02101112|O3|Outcome|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664645|NCT02101112|O2|Outcome|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
664646|NCT02101112|O1|Outcome|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
664647|NCT02101112|E3|Reported Event|Apixaban, 10 mg (Crushed and Mixed With Applesauce)|Participants received a single dose of 10 mg, given by mouth as two 5-mg apixaban commercial tablets crushed and mixed with 30 g of applesauce
664648|NCT02101112|E2|Reported Event|Apixaban, 10 mg (Crushed and Suspended in Water)|Participants received a single dose of apixaban, 10 mg, given by mouth as two 5-mg whole commercial tablets crushed and suspended in 30 mL of water.
664649|NCT02101112|E1|Reported Event|Apixaban, 10 mg (Whole Tablets)|Participants received a single dose of apixaban, 10 mg, given orally as two 5-mg whole commercial tablets.
664650|NCT02101008|B1|Baseline|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
664651|NCT02101008|P1|Participant Flow|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
664652|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
664653|NCT02101008|O1|Outcome|Disulfiram and Chelated Zinc|There is only one arm. All patients are treated wtih disulfiram and chelated zinc. Disulfiram will be administered at a fixed dose of 250 mg orally per day at bedtime. Chelated zinc will be given at a dose of 50 mg orally 3 times a day (with each meal).
664654|NCT02101008|E1|Reported Event|Disulfiram and Chelated Zinc|"There is only one arm. All patients are treated wtih disulfiram and chelated zinc.~disulfiram and chelated zinc"
664655|NCT02100839|B3|Baseline|Total|Total of all reporting groups
664656|NCT02100839|B2|Baseline|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
664657|NCT02100839|B1|Baseline|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
664658|NCT02100839|P2|Participant Flow|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
664659|NCT02100839|P1|Participant Flow|Apolipoprotein E Mimetic (AEM)-28|"Single Ascending Dose (SAD): Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose (MAD): Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
664660|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
664661|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
664662|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
664663|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
664664|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
664665|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
664666|NCT02100839|O2|Outcome|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
664804|NCT02099461|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664667|NCT02100839|O1|Outcome|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
664668|NCT02100839|E2|Reported Event|Normal Saline|"Single Ascending Dose: Single IV dose for each cohort.~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks.~Normal Saline: 0.9% saline for injection"
664669|NCT02100839|E1|Reported Event|AEM-28|"Single Ascending Dose: Single IV dose for each cohort; dose range 0.032 mg/mL to 3.54 mg/mL~Multiple Ascending Dose: Three (3) IV doses for each cohort, one (1) dose every two (2) weeks; dose range 1 mg/kg to 3.54 mg/kg.~AEM-28: Solution for injection"
664670|NCT02100826|B1|Baseline|Overall Study|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).
664671|NCT02100826|P2|Participant Flow|Cephalexin Dosing Sequence BA|Each participant was administered Cephalexin B formulation (Treatment B, Test – 1 occasion) and Cephalexin A formulation (Treatment A, Reference – 1 occasion).There was an interval of 1 day between doses.
664672|NCT02100826|P1|Participant Flow|Cephalexin Dosing Sequence AB|Each participant was administered Cephalexin A formulation (Treatment A, Reference – 1 occasion) and Cephalexin B formulation (Treatment B, Test – 1 occasion).There was an interval of 1 day between doses.
664673|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
664674|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
664675|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
664676|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
664677|NCT02100826|O2|Outcome|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
664678|NCT02100826|O1|Outcome|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
664679|NCT02100826|E2|Reported Event|Cephalexin (Reference)|Cephalexin(Treatment A) manufactured in Mexico by Eli Lilly administered once orally in one of two study periods.
664680|NCT02100826|E1|Reported Event|Cephalexin (Test)|Cephalexin(Treatment B) manufactured in Italy by Facta administered once orally in one of two study periods.
664681|NCT02100644|B1|Baseline|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk
664682|NCT02100644|P3|Participant Flow|Maintenance Phase: LTG Plus VPA|Participants received two different treatments. In one group, participants received a fixed maintenance dose of LTG 200 mg/d (or 100 to 200 mg/d if there were safety concerns during the LTG Escalation Phase) and VPA 100 mg/d (or higher if seizures occurred during the VPA Reduction Phase) were administered twice and 1-3 times daily, respectively, for 12 weeks. The frequency of administration was not changed. If seizures occurred, VPA dose could be increased/re-introduced. On the other group, after VPA was withdrawn, LTG dose was escalated up to 300 mg/d with 50-100 mg increment per 1-2 weeks. If there was safety concern or if remaining dose to 300 mg/d was below 50 mg, 25 mg increment was also available. If seizures occurred, LTG dose was increased up to 400 mg/d. If there was safety concern, LTG dose was decreased to 100 mg/d. If there was still safety concern at 100 mg/d, the participants were discontinued from the study. The total duration of this phase was 12 weeks.
664683|NCT02100644|P2|Participant Flow|Reduction Phase: LTG Plus VPA|Participants received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was determined at the discretion of the investigator or sub-investigator: e.g., 1000 mg/d (2 weeks), 800 mg/d (2 weeks), 600 mg/d (2 weeks), 400 mg/d (2 weeks), 300 mg/d OR 1000 mg/d (4 weeks), 600 mg/d (4 weeks), 300 mg/d and when VPA was reduced to less than 300 mg/d, the dose was reduced to 300, 200, 100, and 0 mg/d in 100 mg decrements in steps of at least one week duration. When VPA was concomitantly used, LTG was administered twice daily with 200 mg/d as a maintenance dose. If there were safety concerns during the LTG Escalation Phase, a fixed maintenance dose of 100 to 200 mg/d of LTG was administered twice daily. When VPA was withdrawn (that is, VPA was reduced to 0 mg/d), LTG was required to be increased by 50-100 mg/d. If there were any safety concern, 25 mg increment was also available. The total duration of this phase was 4 to16 weeks.
664684|NCT02100644|P1|Participant Flow|Escalation Phase: LTG Plus VPA|Participants received a fixed maintenance dose of VPA (400-1200 mg/d) along with lamotrigine (LTG) which was gradually escalated to 200 mg/d in accordance with the information of package insert: i.e. 25 mg of LTG was orally administered once every other day for the first 2 weeks and then once daily for the following 2 weeks. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 weeks for once or twice daily administration. If there were safety concerns, the LTG dose was decreased to 100 mg/d at the discretion of the investigator or sub-investigator. If there were still safety concerns despite the dose reduction to 100 mg/d, LTG was discontinued. The total duration of this phase was 8 to18 weeks.
664714|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664805|NCT02099461|B1|Baseline|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664715|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664809|NCT02099461|O3|Outcome|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664685|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664686|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664687|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664688|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664689|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664690|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664691|NCT02100644|O1|Outcome|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to < 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664749|NCT02099838|B1|Baseline|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664692|NCT02100644|E1|Reported Event|LTG Plus VPA (Phase 1, 2 and 3)|Par. received a fixed maintenance (maint) dose of VPA (400-1200 mg/d) along with LTG gradually escalated to 200 mg/d in accordance with the package insert information: i.e. 25 mg of LTG was orally administered once every other day for the first 2 wk and then once daily for the following 2 wk. Thereafter, LTG was gradually escalated by 25 to 50 mg every 1 to 2 wk for once or twice daily administration. Par. received a range of VPA dose reduction as follows: When VPA was reduced to 300 mg/d, the range of reduction was as follows: 1000 mg/d (2 wk), 800 mg/d (2 wk), 600 mg/d (2 wk), 400 mg/d (2 wk), 300 mg/d OR 1000 mg/d (4 wk), 600 mg/d (4 wk), 300 mg/d and when VPA was reduced to &lt; 300 mg/d, the dose was reduced to 300, 200, 100 and 0 mg/d in 100 mg decrements in steps of at least one wk duration. Par. received a fixed maint dose of LTG 200 mg/d and VPA 100 mg/d or a maint dose of LTG 200-400 mg/d were administered twice and 1-3 times daily for LTG and VPA, respectively, for 12 wk.
664693|NCT02100579|B3|Baseline|Total|Total of all reporting groups
664694|NCT02100579|B2|Baseline|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
664695|NCT02100579|B1|Baseline|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
664696|NCT02100579|P2|Participant Flow|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
664697|NCT02100579|P1|Participant Flow|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
664698|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
664699|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
664700|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
664701|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
664702|NCT02100579|O2|Outcome|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
664703|NCT02100579|O1|Outcome|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
664704|NCT02100579|E2|Reported Event|Control Group|"Ultrasound-guided sham block with 10 ml of preservative free normal saline~Preservative free normal saline: 10 ml of preservative free normal saline"
664705|NCT02100579|E1|Reported Event|Active Group|"Ultrasound-guided adductor canal blockade with 10 ml of 0.25% bupivacaine~Bupivacaine: 10 ml of 0.25% bupivacaine"
664706|NCT02100475|B3|Baseline|Total|Total of all reporting groups
664707|NCT02100475|B2|Baseline|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664708|NCT02100475|B1|Baseline|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664709|NCT02100475|P2|Participant Flow|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664710|NCT02100475|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664711|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664712|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664713|NCT02100475|O2|Outcome|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
665561|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
664716|NCT02100475|O1|Outcome|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664717|NCT02100475|E2|Reported Event|IDegLira + IAsp|IDegLira was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. IDegLira was titrated up to a maximum dose of 50 dose steps (50 units IDeg/1.8 mg Lira) with sequential add-on of bolus insulin aspart (IAsp). Dose titration of insulin aspart was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured daily. All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664718|NCT02100475|E1|Reported Event|IDegLira|Insulin degludec/liraglutide (IDegLira) was given subcutaneously (s.c., under the skin) once daily in combination with metformin. The starting dose of IDegLira was the dose of IDegLira used at the end of the NN9068-3952 trial. Intensification with IDegLira was performed by dose optimisation up to a maximum of 80 dose steps (80 units IDeg/2.9 mg Lira). All subjects continued with metformin at pre-trial doses (≥ 1500 mg or the maximum tolerated dose).
664719|NCT02100410|B1|Baseline|Overall|All treatment sequences
664720|NCT02100410|P6|Participant Flow|Sequence 6|T5 and T6; T3 and T4; T1 and T2
664721|NCT02100410|P5|Participant Flow|Sequence 5|T5 and T6; T1 and T2; T3 and T4
664722|NCT02100410|P4|Participant Flow|Sequence 4|T3 and T4; T5 and T6; T1 and T2
664723|NCT02100410|P3|Participant Flow|Sequence 3|T3 and T4; T1 and T2; T5 and T6
664724|NCT02100410|P2|Participant Flow|Sequence 2|T1 and T2; T5 and T6; T3 and T4
664725|NCT02100410|P1|Participant Flow|Sequence 1|T1 and T2; T3 and T4; T5 and T6
664726|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
664727|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
664728|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
664729|NCT02100410|O6|Outcome|TEST6|Iteration 2-87-3 without embossed mark
664730|NCT02100410|O5|Outcome|TEST5|Iteration 2-87-3 with embossed mark
664731|NCT02100410|O4|Outcome|TEST4|Iteration 2-87-2 without embossed mark
664732|NCT02100410|O3|Outcome|TEST3|Iteration 2-87-2 with embossed mark
664733|NCT02100410|O2|Outcome|TEST2|Iteration 2-87-1 without embossed mark
664734|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
664735|NCT02100410|O3|Outcome|TEST5|Iteration 2-87-3 with embossed mark
664736|NCT02100410|O2|Outcome|TEST3|Iteration 2-87-2 with embossed mark
664737|NCT02100410|O1|Outcome|TEST1|Iteration 2-87-1 with embossed mark
664738|NCT02100410|E2|Reported Event|TEST (2,4,6)|Delefilcon A toric contact lenses without embossed mark, 3 different iterations, crossover all on the same eye
664739|NCT02100410|E1|Reported Event|TEST (1,3,5)|Delefilcon A toric contact lenses with embossed mark, 3 different iterations, crossover all on the same eye
664740|NCT02100189|B1|Baseline|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
664741|NCT02100189|P1|Participant Flow|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
664742|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
664743|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
664744|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
664745|NCT02100189|O1|Outcome|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
664746|NCT02100189|E1|Reported Event|Esophageal Cell Harvesting Procedure|Participants swallow the capsule (Oesotest from Actimed) and then wait 10 minutes before the sponge is pulled out through the esophagus by gentle traction on the string. Cytology samples from the sponge are harvested and analyzed by FISH. Participants then undergo standard EGD or upper endoscopy.
664747|NCT02099838|B3|Baseline|Total|Total of all reporting groups
664748|NCT02099838|B2|Baseline|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
665015|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
664750|NCT02099838|P2|Participant Flow|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664808|NCT02099461|P1|Participant Flow|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
707915|NCT01806857|O2|Outcome|Matching Placebo|
664751|NCT02099838|P1|Participant Flow|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664752|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664753|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664754|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664755|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664756|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664757|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664758|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664759|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664760|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664761|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664762|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664763|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664764|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664765|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664766|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664767|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664768|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664803|NCT02099461|B3|Baseline|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664769|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664770|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664771|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664772|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664773|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664774|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664775|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664776|NCT02099838|O2|Outcome|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664777|NCT02099838|O1|Outcome|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664778|NCT02099838|E2|Reported Event|Placebo|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of placebo twice a day (before breakfast and before dinner) orally for 12 weeks.
664779|NCT02099838|E1|Reported Event|Pioglitazone and Metformin|Type 2 diabetic patients only took SUs previously. During a week for washout before the trial, they received diet and sport instructions, kept the SUs unchanged and didn't use any drugs affecting blood glucose. All participants added 1 tablet of pioglitazone and metformin twice a day (before breakfast and before dinner) orally for 12 weeks.
664780|NCT02099708|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664781|NCT02099708|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664782|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664783|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664784|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664785|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664786|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664787|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664788|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664789|NCT02099708|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664790|NCT02099708|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg, capsules or orally disintegrating (OD) tablets, orally, once, daily for up to 12 months.
664791|NCT02099682|B1|Baseline|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664792|NCT02099682|P1|Participant Flow|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664793|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664794|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664795|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664796|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664797|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664798|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664799|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664800|NCT02099682|O1|Outcome|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664801|NCT02099682|E1|Reported Event|Lansoprazole 15 mg|Lansoprazole 15 mg orally once daily
664802|NCT02099461|B4|Baseline|Total|Total of all reporting groups
664806|NCT02099461|P3|Participant Flow|Denosumab 120 mg|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664807|NCT02099461|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664810|NCT02099461|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664811|NCT02099461|O1|Outcome|No Treatment|Participants received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664812|NCT02099461|E3|Reported Event|Treatment C 120 MG SC|Participants received 120 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664813|NCT02099461|E2|Reported Event|Treatment B 60 MG SC|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664814|NCT02099461|E1|Reported Event|Treatment A No Treatment|Participants in this group received no treatment and underwent percutaneous core needle breast biopsies on Day 1 and Day 28.
664815|NCT02099344|B3|Baseline|Total|Total of all reporting groups
664816|NCT02099344|B2|Baseline|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664817|NCT02099344|B1|Baseline|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664818|NCT02099344|P2|Participant Flow|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664819|NCT02099344|P1|Participant Flow|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664820|NCT02099344|O2|Outcome|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664821|NCT02099344|O1|Outcome|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664822|NCT02099344|E2|Reported Event|Artegraft|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664823|NCT02099344|E1|Reported Event|Propaten|"Artegraft® vs Gore® Propaten®. Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care.~Artegraft: Surgical placement of graft for hemodialysis access~Propaten: Surgical placement of graft for hemodialysis access"
664824|NCT02099318|B3|Baseline|Total|Total of all reporting groups
664825|NCT02099318|B2|Baseline|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664826|NCT02099318|B1|Baseline|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
664827|NCT02099318|P2|Participant Flow|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664864|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
665562|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
664866|NCT02099084|E1|Reported Event|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
664867|NCT02099006|B1|Baseline|All Study Participants|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline/ Baclofen: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
707916|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
664828|NCT02099318|P1|Participant Flow|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
664829|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664830|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
664831|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664832|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
664833|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664834|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
664835|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664836|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches."
664837|NCT02099318|O2|Outcome|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664865|NCT02099084|E2|Reported Event|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
665016|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
664838|NCT02099318|O1|Outcome|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, the SRP will be available for the surgeons during surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation f"
664839|NCT02099318|E2|Reported Event|Control Cases|"Control cases: The control group will be randomly selected according to a predetermined alternating sequence of consecutive prospectively video recorded aneurysm cases. Informed consent from all patients in both the control and SRP groups will be obtained.~Control cases: Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period."
664840|NCT02099318|E1|Reported Event|Active SRP Cases|"SRP cases: After patients have provided written informed consent, the CT and/or MRI images obtained as part of routine preoperative care will be used to construct the model that the neurosurgeons will use in the SRP. No new or additional images will be obtained as part of this study, and the SRP modeling will rely on neuroimaging conducted as part of standard preoperative assessment. For SRP cases, prior to performing surgery, surgeons will plan and rehearse patient-specific cerebral aneurysm surgery. Similarly to the CT/MRI studies, SRP will be available for the surgeons during the surgery for evaluation of optional surgery approaches.~Active SRP cases: The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during surgery for evaluation of optional surgical approaches.~Inclusion criteria:~Patient age >=18 years old with unruptured or ruptured cerebral aneurysm in the anterior circulation for w"
664841|NCT02099266|B1|Baseline|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
664842|NCT02099266|P1|Participant Flow|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
664843|NCT02099266|O1|Outcome|Reduced-Intensity Conditioning|
664844|NCT02099266|O2|Outcome|Myeloablative Conditioning|"Myeloablative transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:~Day -10, -9, and -8: Fludarabine (25 mg/m2 IV) IV Day -7, -6, -5, and -4: Total body irradiation 165 cGy twice daily Day -3 and -2: Cyclophosphamide (60 mg/kg/day ) and mesna 50mg/kg/day (milligrams per kilogram per day) IV"
664845|NCT02099266|O1|Outcome|Reduced-Intensity Conditioning|"Reduced-Intensity (also referred to as: Non‐myeloablative) transplant patients will receive the following chemotherapeutic agents and radiation on the respective days:~Day -6 : fludarabine 40mg/m2 (milligram per meter squared) intravenously (IV), cyclophosphamide 50mg/kg IV, and mesna 50mg/kg IV Day-5 to -2: fludarabine 40mg/m2 intravenously (IV) Day -1: Total body irradiation (TBI) 200 centrigray (cGy)"
664846|NCT02099266|O1|Outcome|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
664847|NCT02099266|E1|Reported Event|Hyperbaric Oxygen Treatment|"Administration of hyperbaric oxygen the morning of UCB transplant.~Administration of hyperbaric oxygen: Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours"
664848|NCT02099084|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Teduglutide first.
664849|NCT02099084|P2|Participant Flow|Placebo First, Then Teduglutide|Placebo administered subcutaneously for 7 days, followed by a 14-day washout period, and Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days.
664850|NCT02099084|P1|Participant Flow|Teduglutide First, Then Placebo|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days, followed by a 14-day washout period, and placebo administered subcutaneously for 7 days.
664851|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
664852|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
664853|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
664854|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
664855|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
664856|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
664857|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
664858|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
664859|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
664860|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
664861|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
664862|NCT02099084|O1|Outcome|Teduglutide|Teduglutide 0.05 mg/kg/d administered subcutaneously for 7 days in either first intervention period or second intervention period
664863|NCT02099084|O2|Outcome|Placebo|Placebo administered subcutaneously daily for 7 days in either first intervention period or second intervention period
664868|NCT02099006|P1|Participant Flow|All Study Participants|"Each study subject was sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline 2%/ Baclofen 2%: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
664869|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
664870|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
664871|NCT02099006|O2|Outcome|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
664872|NCT02099006|O1|Outcome|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
664873|NCT02099006|E2|Reported Event|Placebo|"The compounding base alone will be used as a placebo. Each participant will be given each drug and the placebo sequentially in random order.~placebo: Compounding base to be used alone as a placebo"
664874|NCT02099006|E1|Reported Event|Medications|"Each study subject will be sequentially exposed to each of the study drugs and the placebo in a random order. The study is designed as a double blinded, crossover study.~Amitriptyline: Topical application of the drug at a 2% concentration in combination with 2% Baclofen~Baclofen: Used topically at 2% concentration in combination with 2% amitriptyline~Ketoprofen: To be applied topically at a 10% concentration~Ketamine: To be applied topically at a 10% concentration~Loperamide: To be applied topically at a 5% concentration~Gabapentin: To be applied topically at a 6% concentration"
664875|NCT02098746|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664876|NCT02098746|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664877|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664878|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664879|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664880|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664881|NCT02098746|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664882|NCT02098746|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg, orally once daily before or after breakfast.
664883|NCT02098733|B1|Baseline|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664884|NCT02098733|P1|Participant Flow|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664885|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664886|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664887|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664888|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664889|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664890|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664891|NCT02098733|O1|Outcome|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664892|NCT02098733|E1|Reported Event|Pioglitazone/Glimepiride|Pioglitazone/glimepiride 15 mg/1 mg or 30 mg/3 mg, orally once daily before or after breakfast.
664893|NCT02098395|B5|Baseline|Total|Total of all reporting groups
664894|NCT02098395|B4|Baseline|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
664895|NCT02098395|B3|Baseline|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664896|NCT02098395|B2|Baseline|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
665572|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
664897|NCT02098395|B1|Baseline|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
664898|NCT02098395|P4|Participant Flow|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
664899|NCT02098395|P3|Participant Flow|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664900|NCT02098395|P2|Participant Flow|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664901|NCT02098395|P1|Participant Flow|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
664902|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
664903|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664904|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664905|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
664906|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
664907|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664908|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664909|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
664910|NCT02098395|O4|Outcome|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
664911|NCT02098395|O3|Outcome|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664912|NCT02098395|O2|Outcome|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664913|NCT02098395|O1|Outcome|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
664940|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
688057|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
664914|NCT02098395|E4|Reported Event|Liraglutide Placebo|"Subjects randomised to 3 different placebo arms as an add-on to their pre-trial insulin treatment. Administered subcutaneously (s.c., under the skin) once daily. All the 3 arms were pooled together for data analysis.~Placebo 0.1 mL arm: Subjects received 0.1 mL placebo throughout the trial.~Placebo 0.2 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 24 weeks.~Placebo 0.3 mL arm: Subjects received 0.1 mL placebo for 2 weeks followed by 0.2 mL for 2 weeks and 0.3 mL for next 22 weeks of the trial period."
707917|NCT01806857|O2|Outcome|Matching Placebo|
664915|NCT02098395|E3|Reported Event|Liraglutide 1.8 mg|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects received 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664916|NCT02098395|E2|Reported Event|Liraglutide 1.2 mg|Subjects randomised to 1.2 mg liraglutide treatment as an add-on to their pre-trial insulin treatment received 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 24 weeks. Administered subcutaneously (s.c., under the skin) once daily.
664917|NCT02098395|E1|Reported Event|Liraglutide 0.6 mg|Subjects randomised to 0.6 mg liraglutide treatment as an add-on to their pre-trial insulin treatment and remained on this dose throughout the trial (26 weeks). Administered subcutaneously (s.c., under the skin) once daily.
664918|NCT02098304|B1|Baseline|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging Device~Calcivis Caries Activity Imaging System: Unrestored sound molars and unsound molars imaged with the Calcivis Caries Activity Imaging System"
664919|NCT02098304|P1|Participant Flow|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System
664920|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0), and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Teeth imaged with the Calcivis Caries Activity Imaging System"
664921|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
664922|NCT02098304|O1|Outcome|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
664923|NCT02098304|O1|Outcome|Sound and Unsound Molars|Imaging of unrestored sound molars (ICDAS 0) and third molars (ICDAS 1, 2 or 3) with the Calcivis Caries Activity Imaging System
664924|NCT02098304|E1|Reported Event|Sound and Unsound Molars|"Imaging of unrestored sound molars (ICDAS 0) and third Molars (ICDAS 1,2 or 3) with the Calcivis Caries Activity Imaging System~Calcivis Caries Activity Imaging System: Unrestored sound molars and third molars imaged with the Calcivis Caries Activity Imaging System"
664925|NCT02097849|B3|Baseline|Total|Total of all reporting groups
664926|NCT02097849|B2|Baseline|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664927|NCT02097849|B1|Baseline|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664928|NCT02097849|P2|Participant Flow|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664929|NCT02097849|P1|Participant Flow|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664930|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664931|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664932|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664933|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664934|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664935|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664936|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664937|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664938|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664939|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
665017|NCT02097537|O1|Outcome|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
664941|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664942|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664943|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664944|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664945|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664946|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664947|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664948|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664949|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664950|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664951|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664952|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664953|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664954|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664955|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664956|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664957|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664958|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664959|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664960|NCT02097849|O2|Outcome|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664961|NCT02097849|O1|Outcome|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664962|NCT02097849|E2|Reported Event|Tecfidera Treated Plus Vaccinations|Participants on a stable approved dose of Tecfidera (240 mg BID) for ≥ 6 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664963|NCT02097849|E1|Reported Event|Non-Pegylated IFN Treated Plus Vaccinations|Participants on a stable approved dose of a non pegylated IFN for ≥ 3 months received 3 vaccinations on Day 1 intramuscularly in the specified order: Td 0.5 mL; PPSV23 0.5 mL; MCV4 0.5 mL.
664964|NCT02097823|B3|Baseline|Total|Total of all reporting groups
664965|NCT02097823|B2|Baseline|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
664989|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
688058|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
664990|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
665573|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
664966|NCT02097823|B1|Baseline|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
664967|NCT02097823|P2|Participant Flow|Olanzapine First, Aprepitant Second|"Will receive olanzapine (weight based dose, see below) in first cycle of chemotherapy and aprepitant (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
664968|NCT02097823|P1|Participant Flow|Aprepitant First, Olanzapine Second|"Will receive aprepitant (weight based dose, see below) in first cycle of chemotherapy and olanzapine (weight based dose, see below) in the second cycle of chemotherapy. All doses will be given starting 30 minutes before chemotherapy on day 1.~Olanzapine dosing:~>60kg - 10mg orally daily for 4 doses 40-59.9kg - 5mg orally daily for 4 doses 20-39.9kg - 2.5mg orally daily for 4 doses <20kg - 1.25mg orally daily for 4 doses~Aprepitant dosing:~>40kg - 125mg orally on day 1, then 80mg orally daily on days 2,3 35-39.9kg - 80mg orally daily for 3 doses 20-34.9kg - 40mg orally daily for 3 doses <20kg - 1.5-2mg/kg orally daily for 3 doses~Olanzapine~Aprepitant"
664969|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664970|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664971|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664972|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664973|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664974|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664975|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664976|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664977|NCT02097823|O2|Outcome|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664978|NCT02097823|O1|Outcome|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664979|NCT02097823|O1|Outcome|All Participants|Both intervention arms included
664980|NCT02097823|E2|Reported Event|Olanzapine|Cycles where patients received olanzapine along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664981|NCT02097823|E1|Reported Event|Aprepitant|Cycles where patients received aprepitant along with dexamethasone and ondansetron (regardless of whether cycle 1 or cycle 2)
664982|NCT02097745|B1|Baseline|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664983|NCT02097745|P1|Participant Flow|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664984|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664985|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
664986|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664987|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
664988|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
665013|NCT02097537|B1|Baseline|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
665014|NCT02097537|P1|Participant Flow|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
664991|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
664992|NCT02097745|O2|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664993|NCT02097745|O1|Outcome|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
664994|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664995|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664996|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664997|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664998|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
664999|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
665000|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
665001|NCT02097745|O1|Outcome|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
665002|NCT02097745|E2|Reported Event|Rituximab|Participants received rituximab 1 g intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid ≥ 5 mg/week or equivalent, given as either a single dose or as divided daily doses.
665003|NCT02097745|E1|Reported Event|Placebo|Data for participants who received placebo in study WA17042 are included in this reporting group for data collected up until they received their first dose of rituximab in this study (study WA17531). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
665004|NCT02097719|B3|Baseline|Total|Total of all reporting groups
665005|NCT02097719|B2|Baseline|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
665006|NCT02097719|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
665007|NCT02097719|P2|Participant Flow|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
665008|NCT02097719|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
665009|NCT02097719|O2|Outcome|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
665010|NCT02097719|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
665011|NCT02097719|E2|Reported Event|Travoprost 0.004% and Timolol 0.5%|Travoprost 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
665012|NCT02097719|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
665018|NCT02097537|E1|Reported Event|Methacholine Chloride|"children with bronchial asthma~Methacholine Chloride (SK-1211)"
665019|NCT02097108|B1|Baseline|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
665574|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665020|NCT02097108|P1|Participant Flow|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
665021|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
665022|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
665023|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
665024|NCT02097108|O1|Outcome|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
665025|NCT02097108|E1|Reported Event|Raltegravir|"Patients will be offered to switch their protease inhibitor containing regimen to a raltegravir (400mg twice daily, orally) based regimen while maintaining the same background therapy.~Raltegravir"
665026|NCT02097056|B1|Baseline|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
665027|NCT02097056|P1|Participant Flow|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
665028|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
665029|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
665030|NCT02097056|O1|Outcome|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
665031|NCT02097056|E1|Reported Event|Donepezil Hydrochloride|Donepezil hydrochloride (HCl) at 23 mg was administered once daily, just before bed, for 24 weeks.
665032|NCT02097030|B3|Baseline|Total|Total of all reporting groups
665033|NCT02097030|B2|Baseline|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
665034|NCT02097030|B1|Baseline|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
665035|NCT02097030|P2|Participant Flow|Nelfilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~nelfilcon A: contact lens filcon II 3: contact lens"
665036|NCT02097030|P1|Participant Flow|Etafilcon A, Then Filcon II 3|"Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.~etafilcon A: contact lens filcon II 3: contact lens"
665037|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665038|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665039|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665040|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665041|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665042|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665043|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665044|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665045|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665046|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665047|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665048|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665049|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665050|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665051|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665052|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665053|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665054|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665055|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665056|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665057|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665058|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665059|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665060|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665061|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665062|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665063|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665064|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665065|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665066|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665067|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665068|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665069|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665070|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665071|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665072|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665073|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665074|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665075|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665076|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665077|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665078|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665079|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665080|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665081|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665082|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665083|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665084|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665085|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665086|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665563|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665087|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665127|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
665088|NCT02097030|O2|Outcome|Filcon II 3|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
665089|NCT02097030|O1|Outcome|Hydrogel|"Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A.~(hydrogel: nelfilcon A, etafilcon A) (silicone hydrogel: filcon II 3)"
665090|NCT02097030|O3|Outcome|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665091|NCT02097030|O2|Outcome|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665092|NCT02097030|O1|Outcome|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665093|NCT02097030|E3|Reported Event|Filcon II 3|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665094|NCT02097030|E2|Reported Event|Etafilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665095|NCT02097030|E1|Reported Event|Nelfilcon A|Subjects randomized to wear study pair one then crossover to study pair two. Study pairs are either filcon II 3 and nelfilcon A or filcon II 3 and etafilcon A
665096|NCT02096835|B4|Baseline|Total|Total of all reporting groups
665097|NCT02096835|B3|Baseline|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
665098|NCT02096835|B2|Baseline|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
665099|NCT02096835|B1|Baseline|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
665100|NCT02096835|P3|Participant Flow|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
665101|NCT02096835|P2|Participant Flow|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
665102|NCT02096835|P1|Participant Flow|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
665103|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
665104|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
665105|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
665106|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
665124|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
665125|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
665126|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
665128|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
707918|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
665107|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
665108|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
665109|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
665110|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
665111|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
665112|NCT02096835|O3|Outcome|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
665113|NCT02096835|O2|Outcome|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
665114|NCT02096835|O1|Outcome|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
665115|NCT02096835|E3|Reported Event|Control|"Sham transcutaneous electrical acupoint stimulation. Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Dexamethasone: will be given after induction"
665116|NCT02096835|E2|Reported Event|Tropisetron|"Tropisetron 5mg iv. at the start of skin closure.Sham transcutaneous electrical acupoint stimulation.Dexamethasone 10mg i.v.after induction.~Sham transcutaneous electrical acupoint stimulation: The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.~Tropisetron: will be given at the start of skin closure~Dexamethasone: will be given after induction"
665117|NCT02096835|E1|Reported Event|Acustimulation|"Transcutaneous electrical acupoint stimulation (TEAS) starts 30 min before surgery and lasts until patient leaves the postanesthetic care unit.Dexamethasone 10mg i.v. after induction.~Transcutaneous electrical acupoint stimulation: A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.~Dexamethasone: will be given after induction"
665118|NCT02096744|B1|Baseline|Overall Study|"A randomised, double-blind, 2-way crossover design, followed by a period for assessment of adhesive properties of the clonidine patch.~In the crossover part of the trial, subjects were treated with either Catapres®-TTS delivering 0.3 mg clonidine/24 h (TTS-3) in the Oppanol® formulation (test treatment T1) or Catapres®-TTS-3 (0.3 mg/24 h) with Vistanex™ formulation (reference treatment R1) in each period. In the adhesion phase of the trial, subjects were treated simultaneously with Oppanol® (test treatment T2) and Vistanex™ (reference treatment R2) patches, each delivering 0.1 mg clonidine/24 h (TTS-1)."
665119|NCT02096744|P2|Participant Flow|Catapres®-TTS-3 Crossover 2: TTS-3 Vistanex Then TTS-3 Oppanol|Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Oppanol® (T1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
665120|NCT02096744|P1|Participant Flow|Catapres®-TTS-3 Crossover 1: TTS-3 Oppanol Then TTS-3 Vistanex|Catapres®-TTS(Transdermal Therapeutic System)-3 (0.3 mg/24 hr) Oppanol® (T1) first, followed by Catapres®-TTS-3 (0.3 mg/24 hr) Vistanex™ (R1). Followed by simultaneous administration of TTS-1 Oppanol® (T2) and TTS-1 Vistanex™ (R2) patches each delivering 0.1mg clinidine/24h.
665121|NCT02096744|O2|Outcome|Catapres®-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Vistanex™ (R1)
665122|NCT02096744|O1|Outcome|Catapres®-TTS-3 With Oppanol®|Subject to receive 0.3 mg/24 hr Catapres®-TTS-3 Oppanol® (T1)
665123|NCT02096744|O2|Outcome|Catapres-TTS-3 With Vistanex™|Subject to receive 0.3 mg/24 hr Catapres-TTS-3 Vistanex™ (R1)
665564|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665129|NCT02096744|E3|Reported Event|TTS-1: Vistanex™ (R2) + Oppanol® (T2)|Simultaneous administration of TTS-1 with Oppanol® and TTS-1 with Vistanex™
665130|NCT02096744|E2|Reported Event|TTS-3: Vistanex™ (R1)|Administration of TTS-3 with Vistanex™
665131|NCT02096744|E1|Reported Event|TTS-3: Oppanol® (T1)|Administration of TTS-3 with Oppanol®
665132|NCT02096731|B3|Baseline|Total|Total of all reporting groups
665133|NCT02096731|B2|Baseline|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
665134|NCT02096731|B1|Baseline|Tiotropium|Participants who were new users of tiotropium.
665135|NCT02096731|P2|Participant Flow|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
665136|NCT02096731|P1|Participant Flow|Tiotropium|Participants who were new users of tiotropium.
665137|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
665138|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long- acting bronchodilator.
665139|NCT02096731|O2|Outcome|Combination Therapy|Participants who can be linked to the Hospital Episode Statistics database and who added another long-acting bronchodilator to the previous long-acting bronchodilator.
665140|NCT02096731|O1|Outcome|Monotherapy|Participants who can be linked to the Hospital Episode Statistics database and who remained on a single long-acting bronchodilator.
665141|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
665142|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
665143|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
665144|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
665145|NCT02096731|O2|Outcome|Combination Therapy|Participants who added another long-acting bronchodilator to the previous long-acting bronchodilator (Tiotropium plus LABA+/-ICS) - combination therapy
665146|NCT02096731|O1|Outcome|Monotherapy|Participants remaining on a single long-acting bronchodilator - monotherapy.
665147|NCT02096731|E2|Reported Event|LABA|Participants who were new users of a long-acting beta2 agonist (LABA) with or without inhaled corticosteroid (ICS).
665148|NCT02096731|E1|Reported Event|Tiotropium|Participants who were new users of tiotropium.
665149|NCT02096718|B4|Baseline|Total|Total of all reporting groups
665150|NCT02096718|B3|Baseline|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
665151|NCT02096718|B2|Baseline|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
665152|NCT02096718|B1|Baseline|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
665153|NCT02096718|P3|Participant Flow|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
665154|NCT02096718|P2|Participant Flow|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
665155|NCT02096718|P1|Participant Flow|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
665156|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
665157|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
665158|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
665159|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
665160|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
665161|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
665162|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
665163|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
665202|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665203|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
707919|NCT01806857|O2|Outcome|Matching Placebo|
665164|NCT02096718|O4|Outcome|Afatinib in Healthy Subjects Matched to Severe|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to severe renal impaired subjects
665165|NCT02096718|O3|Outcome|Afatinib in Healthy Subjects Matched to Moderate|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate renal impaired subjects
665166|NCT02096718|O2|Outcome|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
665167|NCT02096718|O1|Outcome|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
665168|NCT02096718|E3|Reported Event|Afatinib in Severe Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to severely renally impaired subjects in fasted state with 240 mL of water
665169|NCT02096718|E2|Reported Event|Afatinib in Moderate Renal Impairment|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to moderately renally impaired subjects in fasted state with 240 mL of water
665170|NCT02096718|E1|Reported Event|Afatinib in Healthy Subjects|Single Dose of 40 mg Afatinib film-coated tablet was orally administered to healthy subjects in fasted state with 240 mL of water; healthy subjects were matched by gender, race, age and BMI to moderate and severe renal impaired subjects
665171|NCT02096705|B3|Baseline|Total|Total of all reporting groups
665172|NCT02096705|B2|Baseline|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
665173|NCT02096705|B1|Baseline|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
665174|NCT02096705|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
665175|NCT02096705|P1|Participant Flow|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
665176|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
665177|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
665178|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
665179|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
665180|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
665181|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
665182|NCT02096705|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
665183|NCT02096705|O1|Outcome|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
665184|NCT02096705|E2|Reported Event|Placebo|Dapagliflozin Placebo 0 mg oral Tablet once daily for 24 weeks + Background Insulin
665185|NCT02096705|E1|Reported Event|Dapagliflozin|Dapagliflozin 10 mg oral Tablet once daily for 24 weeks + Background Insulin
665186|NCT02096692|B1|Baseline|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
665187|NCT02096692|P1|Participant Flow|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
665188|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
665189|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
665190|NCT02096692|O1|Outcome|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
665191|NCT02096692|E1|Reported Event|ICD System Therapy|"Patients with a ProMRI ICD System~Patients with a ProMRI ICD System: Tachycardia Fast Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine"
665192|NCT02096679|B1|Baseline|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665193|NCT02096679|P1|Participant Flow|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665194|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665195|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665196|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665197|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665198|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665199|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665200|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665201|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665565|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665204|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665205|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665206|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665207|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665208|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665209|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665210|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665211|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665212|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665213|NCT02096679|O1|Outcome|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665214|NCT02096679|E1|Reported Event|AZD9291 20mg|20 mg [14C]-AZD9291 oral solution (free base equivalent) containing a nominal dose 1 μCi (0.037 MBq) activity as a single administration on Day 1
665215|NCT02096575|B3|Baseline|Total|Total of all reporting groups
665216|NCT02096575|B2|Baseline|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665217|NCT02096575|B1|Baseline|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
665218|NCT02096575|P3|Participant Flow|Excluded|Participants that were withdrawn from the study after consent
665219|NCT02096575|P2|Participant Flow|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665220|NCT02096575|P1|Participant Flow|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration"
665221|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665222|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
665223|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665224|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
665245|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665225|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665226|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
665227|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665228|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
665229|NCT02096575|O2|Outcome|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665230|NCT02096575|O1|Outcome|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~In addition, the Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously."
665231|NCT02096575|E2|Reported Event|Standard Care Group|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The standard care group will receive one 5/325 mg Percocet, and 1 mg of lorazepam, 30 minutes before the procedure. The standard care group will receive oxygen by mask intraoperatively."
665232|NCT02096575|E1|Reported Event|Nitrous Oxide Administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. All patients will receive local anesthesia via a standardized paracervical block with 18 cc of 1% lidocaine buffered with 2 ml of 8.4% sodium bicarbonate and 0.2 ml of 4 units of vasopressin.~The Nitrous oxide group will receive two placebo pills. Nitrous oxide will be administered via a disposable scented nasal mask to blind patients to the intervention. Nitrous oxide will be administered at a fixed ratio of 60% nitrous oxide and 40% oxygen. The nasal mask will be placed on the patient's nose and the nitrous oxide will be administered continuously.~Nitrous oxide administration: The NO group will get two placebo pills."
665233|NCT02096458|B1|Baseline|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
665234|NCT02096458|P1|Participant Flow|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
665235|NCT02096458|O1|Outcome|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
665236|NCT02096458|E1|Reported Event|Dexlansoprazole|Single oral dose of 30 mg dexlansoprazole delayed-release orally disintegrating tablet
665237|NCT02096081|B3|Baseline|Total|Total of all reporting groups
665238|NCT02096081|B2|Baseline|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665239|NCT02096081|B1|Baseline|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665240|NCT02096081|P2|Participant Flow|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665241|NCT02096081|P1|Participant Flow|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665242|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665243|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665244|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665246|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665247|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665248|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665249|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665250|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665251|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665252|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665253|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665254|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665255|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665256|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665257|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665258|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665259|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665260|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665261|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665262|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665263|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665264|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665265|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665266|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665267|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665268|NCT02096081|O2|Outcome|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665269|NCT02096081|O1|Outcome|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665270|NCT02096081|E2|Reported Event|OnabotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~OnabotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665271|NCT02096081|E1|Reported Event|IncobotulinumtoxinA|"20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points.~IncobotulinumtoxinA: 20U/injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection"
665272|NCT02095873|B3|Baseline|Total|Total of all reporting groups
665273|NCT02095873|B2|Baseline|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: 108 mg mannitol), once daily, 8 weeks; then Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
665566|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665274|NCT02095873|B1|Baseline|Glyoxalase 1 Inducer Then Placebo|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks; then Placebo (excipient: 108 mg mannitol), once daily, 8 weeks.
665275|NCT02095873|P2|Participant Flow|Placebo Then Glyoxalase 1 Inducer|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks; then Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
665276|NCT02095873|P1|Participant Flow|Glyoxalase 1 Inducer First, Then Placebo|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks; then Placebo (excipient: Mannitol, 108 mg) once daily, 8 weeks.
665277|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
665278|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
665279|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
665280|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
665281|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: Mannitol, 108 mg), once daily, 8 weeks.
665282|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (capsule, 90 mg trans-resveratrol & 120 mg hesperetin combination) once daily, 8 weeks.
665283|NCT02095873|O2|Outcome|Placebo|Placebo (excipient: 108 mg mannitol), capsule, once daily, 8 weeks.
665284|NCT02095873|O1|Outcome|Glyoxalase 1 Inducer|Glyoxalase 1 inducer (90 mg trans-resveratrol & 120 mg hesperetin), once daily, 8 weeks.
665285|NCT02095873|E2|Reported Event|Placebo Then Glo1-inducer|Placebo capsule (mannitol, 210 mg), once daily for 8 weeks; then 6-weeks washout; then Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks.
665286|NCT02095873|E1|Reported Event|Glo1-inducer Then Placebo|Glyoxalase 1 inducer: capsule, 90 mg trans-resveratrol & 120 mg hesperetin, once daily for 8 weeks; then 6-weeks washout; then placebo capsule (mannitol, 210 mg), once daily for 8 weeks.
665287|NCT02095691|B1|Baseline|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
665288|NCT02095691|P1|Participant Flow|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
665289|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP reduction at 12 months follow up
665290|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP reduction at 6 months follow up
665291|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP reduction at 3 months follow up
665292|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP reduction at 1 month follow up
665293|NCT02095691|O4|Outcome|At 12 Month Follow Up|Percentage of subjects achieving target SBP at 12 months follow up
665294|NCT02095691|O3|Outcome|At 6 Months Follow Up|Percentage of subjects achieving target SBP at 6 months follow up
665295|NCT02095691|O2|Outcome|At 3 Months Follow Up|Percentage of subjects achieving target SBP at 3 months follow up
665296|NCT02095691|O1|Outcome|At 1 Month Follow up|Percentage of subjects achieving target SBP at 1 month follow up
665297|NCT02095691|O4|Outcome|Change in Blood Pressure at 12 Month Follow Up|Change in Blood Pressure from baseline to 12 months follow up
665298|NCT02095691|O3|Outcome|Change in Blood Pressure at 6 Months Follow Up|Change in Blood Pressure from baseline to 6 months follow up
665299|NCT02095691|O2|Outcome|Change in Blood Pressure at 3 Months Follow Up|Change in Blood Pressure from baseline to3 months follow up
665300|NCT02095691|O1|Outcome|Change in Blood Pressure at 1 Month Follow up|Change in Blood Pressure from baseline to1 month follow up
665301|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
665302|NCT02095691|O1|Outcome|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
665303|NCT02095691|E1|Reported Event|Renal Artery Sympathetic Denervation|Subjects enrolled in this study underwent the renal artery sympathetic denervation procedure for treating moderate resistant hypertension. The procedure was conducted with the investigational Celsius® ThermoCool® Renal Denervation catheter.
665304|NCT02095561|B3|Baseline|Total|Total of all reporting groups
665305|NCT02095561|B2|Baseline|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
665306|NCT02095561|B1|Baseline|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
665307|NCT02095561|P2|Participant Flow|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
665308|NCT02095561|P1|Participant Flow|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
665309|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
665397|NCT02094885|E1|Reported Event|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
665398|NCT02094677|B3|Baseline|Total|Total of all reporting groups
665399|NCT02094677|B2|Baseline|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665310|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
665311|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
665312|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
665313|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
665314|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
665315|NCT02095561|O2|Outcome|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
665316|NCT02095561|O1|Outcome|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
665317|NCT02095561|E2|Reported Event|HPV at Health Centers|Community Health Workers instructed women about cervical cancer and HPV testing and advised them on how to seek screening at health centers.
665318|NCT02095561|E1|Reported Event|HPV Self Testing|"HPV self testing offered by CHWs during home visits~HPV self testing: Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it."
665319|NCT02095223|B3|Baseline|Total|Total of all reporting groups
665320|NCT02095223|B2|Baseline|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
665321|NCT02095223|B1|Baseline|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
665322|NCT02095223|P2|Participant Flow|Traditional Exercise Group|"Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only."
665323|NCT02095223|P1|Participant Flow|Electromyographic Biofeedback Group|"Participants in the electromyographic biofeedback supplemented exercise will be instructed on correct setup and use of the electromyographic biofeedback unit. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group. Participants in will be instructed on a 14 day exercise protocol on the day of enrollment. The protocol is comprised of 4 exercises focused on both non-weight bearing and weight bearing quadriceps strengthening. A compliance log will be given to each participant and will be reviewed at each supervised exercise session and at the final study visit. Participants will be instructed to discontinue exercise and contact the principle investigator if they experience knee pain due to the intervention.~Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest."
665324|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
665325|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
665326|NCT02095223|O2|Outcome|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
665327|NCT02095223|O1|Outcome|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
665328|NCT02095223|E2|Reported Event|Traditional Exercise Group|Traditional Exercise: All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
665329|NCT02095223|E1|Reported Event|Electromyographic Biofeedback Group|Electromyographic Biofeedback: Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
665330|NCT02095197|B3|Baseline|Total|Total of all reporting groups
665331|NCT02095197|B2|Baseline|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665332|NCT02095197|B1|Baseline|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665333|NCT02095197|P2|Participant Flow|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665334|NCT02095197|P1|Participant Flow|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665335|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665336|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665337|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665338|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665339|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665340|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665341|NCT02095197|O2|Outcome|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665342|NCT02095197|O1|Outcome|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665343|NCT02095197|E2|Reported Event|Catheter Targeted Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~Catheter targeted delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665511|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
665512|NCT02094261|E1|Reported Event|AZD9291 80mg|Daily single dose of AZD9291 80mg
665344|NCT02095197|E1|Reported Event|No Catheter Delivery|"Cervical epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.~No Catheter Delivery will be used to deliver the medication.~Triamcinolone 80mg: C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc."
665345|NCT02095158|B1|Baseline|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
665346|NCT02095158|P1|Participant Flow|Oxymetazoline HCL Cream 1.0%|Oxymetazoline hydrogen chloride (HCL) Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
665347|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
665348|NCT02095158|O1|Outcome|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
665349|NCT02095158|E1|Reported Event|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 52 weeks.
665350|NCT02094937|B1|Baseline|Period 1- FF/VI 100/25 mcg OD|Participants received FF/VI 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
665351|NCT02094937|P4|Participant Flow|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665352|NCT02094937|P3|Participant Flow|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665353|NCT02094937|P2|Participant Flow|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665354|NCT02094937|P1|Participant Flow|FF/VI 100/25 mcg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
665355|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665356|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665357|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665358|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665359|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665360|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665361|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665362|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665363|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665364|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665365|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665366|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665367|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665368|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665513|NCT02093949|B3|Baseline|Total|Total of all reporting groups
665567|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665369|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665370|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665371|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665372|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665373|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665374|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665375|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665376|NCT02094937|O3|Outcome|FP 250 mcg BD|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665377|NCT02094937|O2|Outcome|FP 100 mcg BD|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665378|NCT02094937|O1|Outcome|FF 100 mcg OD|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665379|NCT02094937|E4|Reported Event|FP 250 mcg BD Period 2|Participants received FP 250 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665380|NCT02094937|E3|Reported Event|FP 100 mcg BD Period 2|Participants received FP 100 mcg BD morning and evening and FF matching placebo OD in the evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665381|NCT02094937|E2|Reported Event|FF 100 mcg OD Period 2|Participants received FF 100 mcg OD in the evening and Fluticasone Propionate (FP) matching placebo twice-daily (BD) morning and evening, via a dry powder inhaler for 12 weeks in the double-blind treatment period. Participants were allowed to use salbutamold as a rescue medication throughout the study.
665382|NCT02094937|E1|Reported Event|FF/VI 100/25 mcg OD Period 1|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 microgram (mcg) once daily (OD) via a dry powder inhaler for 8 weeks in the open-label treatment period. Participants were allowed to use rescue medication during the study.
665383|NCT02094885|B3|Baseline|Total|Total of all reporting groups
665384|NCT02094885|B2|Baseline|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
665385|NCT02094885|B1|Baseline|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
665386|NCT02094885|P2|Participant Flow|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
665387|NCT02094885|P1|Participant Flow|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
665388|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
665389|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
665390|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
665391|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
665392|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
665393|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
665394|NCT02094885|O2|Outcome|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
665395|NCT02094885|O1|Outcome|Bioseal Fibrin Sealant|A porcine-derived fibrin sealant consisting of thrombin and fibrinogen.
665396|NCT02094885|E2|Reported Event|Manual Compression|Manual compression (MC) include any active or inactive adjunctive treatment to hemostasis methods currently used based on each surgeons surgical practice except for the use of other fibrin sealants.
688059|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
665400|NCT02094677|B1|Baseline|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665401|NCT02094677|P2|Participant Flow|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665402|NCT02094677|P1|Participant Flow|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665403|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665404|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665405|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665406|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665407|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665408|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665409|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665410|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665411|NCT02094677|O2|Outcome|Control - Nelilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665412|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665413|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665414|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665415|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665416|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665417|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665418|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665419|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665420|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665421|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665422|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665423|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665514|NCT02093949|B2|Baseline|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
665424|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665425|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
665426|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens"
665427|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665428|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665429|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665430|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665431|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665432|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665433|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665434|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665435|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665436|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665437|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665438|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665439|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665440|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665441|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665442|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665443|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665444|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665445|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665446|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665447|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665448|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665449|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665450|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665451|NCT02094677|O2|Outcome|Control - Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665452|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665453|NCT02094677|O2|Outcome|Control - Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665454|NCT02094677|O1|Outcome|Filcon II 3|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665455|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665456|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665457|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665458|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665459|NCT02094677|O2|Outcome|Filcon II 3 and Nelfilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~nelfilcon A: Participants were randomized to wear nelfilcon A control lens."
665460|NCT02094677|O1|Outcome|Filcon II 3 and Etafilcon A|"Participants were randomized to a test and control lens in a contralateral design.~filcon II 3: Participants were randomized to wear filcon II 3 test lens.~etafilcon A: Participants were randomized to wear etafilcon A control lens."
665461|NCT02094677|E2|Reported Event|Filcon II 3 and Nelfilcon A|"Participants wear one of their habitual brand lenses (nelfilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~nelfilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
665462|NCT02094677|E1|Reported Event|Filcon II 3 and Etafilcon A|"Participants wear one of their habitual brand lenses (etafilcon A) in one eye, (comparator) and one comparator lens (filcon II 3) in the other eye.~filcon II 3: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other.~etafilcon A: Participants wear one of their habitual brand lenses in one eye (comparator) and one lens of test lens in the other."
665463|NCT02094443|B3|Baseline|Total|Total of all reporting groups
665464|NCT02094443|B2|Baseline|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665465|NCT02094443|B1|Baseline|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665466|NCT02094443|P2|Participant Flow|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665467|NCT02094443|P1|Participant Flow|Alisporivir 300 mg BID|Alisporivir (ALV) 300 mg twice per day (BID) with ribavirin (RBV) for up to 24 weeks.
665468|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665469|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665470|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665471|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665472|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665473|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665474|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665475|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665476|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665477|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665478|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665479|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665480|NCT02094443|O2|Outcome|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665481|NCT02094443|O1|Outcome|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665482|NCT02094443|E2|Reported Event|Alisporivir 400 mg BID|ALV 400 mg BID with RBV for up to 24 weeks.
665483|NCT02094443|E1|Reported Event|Alisporivir 300 mg BID|ALV 300 mg BID with RBV for up to 24 weeks.
665484|NCT02094352|B3|Baseline|Total|Total of all reporting groups
665485|NCT02094352|B2|Baseline|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
665555|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665556|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665515|NCT02093949|B1|Baseline|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
665486|NCT02094352|B1|Baseline|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
665487|NCT02094352|P2|Participant Flow|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
665488|NCT02094352|P1|Participant Flow|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
665489|NCT02094352|O2|Outcome|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
665490|NCT02094352|O1|Outcome|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
665491|NCT02094352|E2|Reported Event|Control Group + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of SALINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three saline booster infusions over the course of three months.~Control Group + Epidural infusion: The saline and epidural infusions will be administered over 96 hours with appropriate titration.~Control Group Booster Infusion: Patients will receive three saline booster infusions over the course of three months."
665492|NCT02094352|E1|Reported Event|Ketamine Infusion + Epidural Infusion + Booster Infusion|"Inpatient: Patients will receive a subanesthetic continuous intravenous infusion of KETAMINE 500mg/500ml in 0.9% Sodium Chloride with an epidural infusion.~Outpatient: Patients will receive three ketamine booster infusions over the course of three months.~Ketamine Infusion + Epidural Infusion: The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.~Ketamine Booster Infusion: Patients will receive three ketamine booster infusions over the course of three months."
665493|NCT02094326|B1|Baseline|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665494|NCT02094326|P1|Participant Flow|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665495|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665496|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665497|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665498|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665499|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the classification of rheumatoid arthritis (ACR) 2010 criteria from 2008 to 2012, and initiated on at least one disease-modifying antirheumatic drug (DMARD) during this period.
665500|NCT02094326|O1|Outcome|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665501|NCT02094326|E1|Reported Event|Patients Whom Fulfilled the ACR|Patients whom fulfilled the ACR 2010 criteria from 2008 to 2012, and initiated on at least one DMARD during this period.
665502|NCT02094300|B1|Baseline|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
665503|NCT02094300|P1|Participant Flow|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
665504|NCT02094300|O1|Outcome|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
665505|NCT02094300|E1|Reported Event|Zenith® Dissection Endovascular Graft|The Zenith® Dissection Endovascular System is intended for the treatment of patients with aortic dissection of the descending thoracic aorta having anatomy amenable to endovascular repair.
665506|NCT02094261|B1|Baseline|AZD9291 80mg|Daily single dose of AZD9291 80mg
665507|NCT02094261|P1|Participant Flow|AZD9291 80mg|Daily single dose of AZD9291 80mg
665508|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
665509|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
665510|NCT02094261|O1|Outcome|AZD9291 80mg|Daily single dose of AZD9291 80mg
665516|NCT02093949|P2|Participant Flow|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
665517|NCT02093949|P1|Participant Flow|Substrate Ablation|Between September 2013 and July 2014, 105 patients with AF were prospectively enrolled at three centers performing substrate ablation (without pulmonary vein isolation) routinely
665518|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
665519|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
665520|NCT02093949|O2|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach
665521|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation.
665522|NCT02093949|O2|Outcome|Historical Control Long Term Follow-up|"Out of the 47 patients included in the validation set arm, only 42 finished the 18-mlonth follow-up. 2 patients were lost to follow-up~Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"
665523|NCT02093949|O1|Outcome|Substrate Ablation Long Term Follow-up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.~9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
665524|NCT02093949|O2|Outcome|Historical Control Long Term Follow-up|"Out of the 47 patients included in the validation set arm, only 42 finished the 18-mlonth follow-up. 2 patients were lost to follow-up~Population at the end of follow up : 3 patients dropped out during the blanking period (1 died of heart failure and 2 relocated)"
665525|NCT02093949|O1|Outcome|Substrate Ablation Long Term Follow Up|"Out of the 105 patients included in the substrate ablation arm, only 96 were included in the long term follow-up group.~9 patients (8.6%) did not complete the follow up: 1 patient died 2 months before the end of follow-up (myocardial infarction) and 8 were lost to follow-up because of relocation."
665526|NCT02093949|O2|Outcome|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
665527|NCT02093949|O1|Outcome|Substrate Ablation|Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
665528|NCT02093949|O2|Outcome|Historical Control|Validation set (n=47) The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
665529|NCT02093949|O1|Outcome|Substrate Ablation|Study population (n=105) Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
665530|NCT02093949|O2|Outcome|Historical Control|The validation set included a cohort of 47 patients with symptomatic drug-refractory AF who underwent ablation using a conventional approach.
665531|NCT02093949|O1|Outcome|Substrate Ablation|Between September 2013 and July 2014, 105 patients were enrolled in 3 centers performing routinely Atrial Fibrillation ablation guided by spatio-temporal electrogram dispersion without pulmonary vein Isolation
665532|NCT02093949|E2|Reported Event|Historical Control|Validation set (n=47)
665533|NCT02093949|E1|Reported Event|Substrate Ablation|Study population (n=105)
665534|NCT02093923|B6|Baseline|Total|Total of all reporting groups
665535|NCT02093923|B5|Baseline|Placebo|Placebo administered twice, two weeks apart
665536|NCT02093923|B4|Baseline|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665537|NCT02093923|B3|Baseline|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665538|NCT02093923|B2|Baseline|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665539|NCT02093923|B1|Baseline|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665540|NCT02093923|P5|Participant Flow|Placebo|Placebo administered twice, two weeks apart
665541|NCT02093923|P4|Participant Flow|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665542|NCT02093923|P3|Participant Flow|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665543|NCT02093923|P2|Participant Flow|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665544|NCT02093923|P1|Participant Flow|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665545|NCT02093923|O4|Outcome|Placebo|Placebo administered twice, two weeks apart
665546|NCT02093923|O3|Outcome|DX-2930, Combined Dose Level 3 and Dose Level 4|This arm includes the total subjects analysed for Dose level 3 and Dose level 4 combined.
665547|NCT02093923|O2|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665548|NCT02093923|O1|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665549|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665550|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665551|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665552|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665553|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665554|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665568|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665569|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
707920|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
665575|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665576|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665577|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665578|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
665579|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665580|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665581|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665582|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665583|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
665584|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665585|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665586|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665587|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665588|NCT02093923|O5|Outcome|Placebo|Placebo administered twice, two weeks apart
665589|NCT02093923|O4|Outcome|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665590|NCT02093923|O3|Outcome|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665591|NCT02093923|O2|Outcome|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665592|NCT02093923|O1|Outcome|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665593|NCT02093923|E5|Reported Event|Placebo|Placebo administered twice, two weeks apart
665594|NCT02093923|E4|Reported Event|DX-2930, Dose Level 4|400 mg of DX-2930 administered twice, two weeks apart
665595|NCT02093923|E3|Reported Event|DX-2930, Dose Level 3|300 mg of DX-2930 administered twice, two weeks apart
665596|NCT02093923|E2|Reported Event|DX-2930, Dose Level 2|100 mg of DX-2930 administered twice, two weeks apart
665597|NCT02093923|E1|Reported Event|DX-2930, Dose Level 1|30 mg of DX-2930 administered twice, two weeks apart
665598|NCT02093897|B1|Baseline|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
665599|NCT02093897|P1|Participant Flow|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an intravenous (IV) infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the World Federation of Hemophilia (WFH), with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
665600|NCT02093897|O1|Outcome|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
665601|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
665602|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
665603|NCT02093897|O1|Outcome|Pharmacokinetic Population|The PK Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
665604|NCT02093897|O1|Outcome|Pharmacokinetic Population|The Pharmacokinetic (PK) Population comprised those subjects who participated in the PK assessment and received at least 1 dose of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile of rVIII-SingleChain.
665831|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
665832|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
665605|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665622|NCT02093819|B5|Baseline|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665988|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665606|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665607|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665608|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665609|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665610|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665611|NCT02093897|O2|Outcome|Prophylaxis|"Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665612|NCT02093897|O1|Outcome|On-demand|"Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions. Preventative and additional doses of rVIII-SingleChain were allowed. Preventative dose was defined as a dose taken before an activity or a minor procedure to prevent or minimize a bleeding episode, and additional dose was defined as a dose taken beyond the need to control hemostasis."
665613|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
665614|NCT02093897|O2|Outcome|Prophylaxis|Subjects receiving routine prophylaxis treatment were initially treated with 15-50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based upon available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose or dosing frequency may have been adjusted if necessary.
665615|NCT02093897|O1|Outcome|On-demand|Subjects assigned to the on-demand treatment regimen treated themselves, or were treated by a caregiver/guardian, as needed for any bleeding episode and did not receive routine assigned infusions.
665616|NCT02093897|O1|Outcome|Efficacy Population|The Efficacy Population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either a routine prophylaxis or on-demand regimen during the study. One subject was excluded from the efficacy population because of a pre-existing inhibitor to FVIII (confirmed by reexamination of a screening sample initially reported as negative due to laboratory error).
665617|NCT02093897|E1|Reported Event|rVIII-SingleChain|Subjects were assigned to either an on-demand or prophylaxis regimen and received rVIII-SingleChain as an IV infusion. Subjects assigned to a prophylaxis regimen were treated with 15 to 50 IU/kg of rVIII-SingleChain every second day or 2 to 3 times per week, or at the investigator’s discretion, based on available PK data, the FVIII treatment regimen used before enrollment and/or the subject’s bleeding phenotype. The dose for on-demand treatment of a bleeding episode was based on the recommendations of the WFH, with a minimum dose of 15 IU/kg. All subjects were to be treated for a minimum of 50 EDs. For the PK evaluation, the subjects received a single IV dose of 50 IU/kg of rVIII-SingleChain on Day 1 at the start of the PK evaluation period.
665618|NCT02093819|B9|Baseline|Total|Total of all reporting groups
665619|NCT02093819|B8|Baseline|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665833|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
665834|NCT02092961|E4|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
665620|NCT02093819|B7|Baseline|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665621|NCT02093819|B6|Baseline|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665623|NCT02093819|B4|Baseline|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665624|NCT02093819|B3|Baseline|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665625|NCT02093819|B2|Baseline|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665626|NCT02093819|B1|Baseline|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665627|NCT02093819|P8|Participant Flow|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665628|NCT02093819|P7|Participant Flow|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665629|NCT02093819|P6|Participant Flow|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665630|NCT02093819|P5|Participant Flow|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665631|NCT02093819|P4|Participant Flow|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665632|NCT02093819|P3|Participant Flow|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665633|NCT02093819|P2|Participant Flow|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665634|NCT02093819|P1|Participant Flow|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665635|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665636|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665637|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665638|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665639|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665640|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665641|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665642|NCT02093819|O7|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665643|NCT02093819|O6|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665644|NCT02093819|O5|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665645|NCT02093819|O4|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665646|NCT02093819|O3|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (Dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665647|NCT02093819|O2|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665648|NCT02093819|O1|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665649|NCT02093819|O8|Outcome|BI 416970 600mg|The medication was administered as a single oral dose (Dose = 600mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665835|NCT02092961|E3|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
665650|NCT02093819|O7|Outcome|BI 416970 400mg|The medication was administered as a single oral dose (Dose = 400mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665651|NCT02093819|O6|Outcome|BI 416970 200mg|The medication was administered as a single oral dose (Dose = 200mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665652|NCT02093819|O5|Outcome|BI 416970 100mg|The medication was administered as a single oral dose (Dose = 100mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665653|NCT02093819|O4|Outcome|BI 416970 50mg|The medication was administered as a single oral dose (dose = 50mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665654|NCT02093819|O3|Outcome|BI 416970 25mg|The medication was administered as a single oral dose (Dose = 25mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665655|NCT02093819|O2|Outcome|BI 416970 10mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665656|NCT02093819|O1|Outcome|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h
665657|NCT02093819|E10|Reported Event|Total Treatment|All patients affected by AEs during entire treatment period.
665658|NCT02093819|E9|Reported Event|Total BI 416970 Treatment|All patients affected by AEs during administration of BI 416970 medication .
665659|NCT02093819|E8|Reported Event|BI 416970 600 mg|The medication was administered as a single oral dose (dose = 600 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665660|NCT02093819|E7|Reported Event|BI 416970 400 mg|The medication was administered as a single oral dose (dose = 400 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665661|NCT02093819|E6|Reported Event|BI 416970 200 mg|The medication was administered as a single oral dose (dose = 200 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665662|NCT02093819|E5|Reported Event|BI 416970 100 mg|The medication was administered as a single oral dose (dose = 100 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665663|NCT02093819|E4|Reported Event|BI 416970 50 mg|The medication was administered as a single oral dose (dose = 50 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665664|NCT02093819|E3|Reported Event|BI 416970 25 mg|The medication was administered as a single oral dose (dose = 25 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665665|NCT02093819|E2|Reported Event|BI 416970 10 mg|The medication was administered as a single oral dose (dose = 10 mg) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665666|NCT02093819|E1|Reported Event|Placebo|The medication was administered as a single oral dose (Dose = NA) with a total of about 240 mL water in the standing or sitting position following an overnight fast of at least 10 h.
665667|NCT02093702|B3|Baseline|Total|Total of all reporting groups
665668|NCT02093702|B2|Baseline|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
665669|NCT02093702|B1|Baseline|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
665670|NCT02093702|P2|Participant Flow|Structured PA Education Program for People With T2DM|Subjects in the experimental arm (n = 3) participated in a structured PA education program for people with T2DM.
665671|NCT02093702|P1|Participant Flow|Standard PA Education for People With T2DM (From a CDE)|Subjects in the control arm (n = 2) received the standard approach to PA education from a Canadian Certified Diabetes Educator (CDE).
665672|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665673|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665674|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665675|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665676|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665677|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665678|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665679|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665680|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665681|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665836|NCT02092961|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
665682|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665683|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665684|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665685|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665686|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665687|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665688|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665689|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665690|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665691|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665692|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665693|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665694|NCT02093702|O2|Outcome|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665695|NCT02093702|O1|Outcome|Standard PA Education for People With T2DM (From a CDE)|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665696|NCT02093702|E2|Reported Event|Standard PA Education for People With T2DM (From a CDE)|Group of subjects receiving physical activity (PA) education from a Certified Diabetes Educator (CDE).
665697|NCT02093702|E1|Reported Event|Structured PA Education Program for People With T2DM|Group of subjects with Type 2 Diabetes Mellitus (T2DM) receiving physical activity (PA) education from the Registered Kinesiologist and YMCA Wellness Coach.
665698|NCT02093390|B3|Baseline|Total|Total of all reporting groups
665699|NCT02093390|B2|Baseline|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665700|NCT02093390|B1|Baseline|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665701|NCT02093390|P2|Participant Flow|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on Days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on Day 10 then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665702|NCT02093390|P1|Participant Flow|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on Day 10 then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665703|NCT02093390|O1|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665704|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665705|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665706|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665707|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665708|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665837|NCT02092961|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
665709|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665710|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665711|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665712|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665713|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665714|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665715|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665716|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665717|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665718|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665719|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665720|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665721|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665722|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665723|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665724|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665725|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665726|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665727|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665728|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665729|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665838|NCT02092857|B4|Baseline|Total|Total of all reporting groups
665839|NCT02092857|B3|Baseline|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
665730|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665731|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665732|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665733|NCT02093390|O2|Outcome|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665734|NCT02093390|O1|Outcome|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665735|NCT02093390|E2|Reported Event|TAK-385 + Atorvastatin|TAK-385 40 mg, tablet, orally once on Day 1 and atorvastatin 80 mg, tablet, orally once daily on days 6 to 9 followed by a single dose of TAK-385 in combination with atorvastatin 80 mg on 10 day then atorvastatin 80 mg, tablet, orally once daily alone on Days 11 to 14.
665736|NCT02093390|E1|Reported Event|TAK-385 + Fluconazole|TAK-385 40 mg, tablet, orally once on Day 1 and fluconazole 400 mg, tablet, orally on Day 6 then 200 mg, tablet, orally once daily on Days 7 to 9 followed by a single dose of TAK-385 in combination with fluconazole 200 mg on 10 day then fluconazole 200 mg, tablet, orally once daily alone on Days 11 to 14.
665737|NCT02093351|B4|Baseline|Total|Total of all reporting groups
665738|NCT02093351|B3|Baseline|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665739|NCT02093351|B2|Baseline|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665740|NCT02093351|B1|Baseline|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665741|NCT02093351|P3|Participant Flow|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665742|NCT02093351|P2|Participant Flow|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665743|NCT02093351|P1|Participant Flow|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665744|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
665745|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
665746|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
665747|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
665748|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
665749|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
665750|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
665751|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
665752|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
665753|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
665754|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
665840|NCT02092857|B2|Baseline|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
665755|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
665756|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
665845|NCT02092857|O3|Outcome|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
665757|NCT02093351|O1|Outcome|Cohort 3 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
665758|NCT02093351|O2|Outcome|Cohort 3 - Olaparib + Letrozole (Treatment Period 3)|Patients in Cohort 3 received letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 39 to Day 43. Blood sampling for PK analysis was taken on Day 43.
665759|NCT02093351|O1|Outcome|Cohort 3 - Letrozole Alone (Treatment Period 2)|Patients in Cohort 3 received letrozole 2.5 mg od from Day 10 to Day 38. Blood sampling for PK analysis was taken on Day 38.
665760|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
665761|NCT02093351|O1|Outcome|Cohort 2 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
665762|NCT02093351|O2|Outcome|Cohort 2 - Olaparib + Anastrozole (Treatment Period 3)|Patients in Cohort 2 received anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 20 to Day 24. Blood sampling for PK analysis was taken on Day 24.
665763|NCT02093351|O1|Outcome|Cohort 2 - Anastrozole Alone (Treatment Period 2)|Patients in Cohort 2 received anastrozole 1 mg od from Day 10 to Day 19. Blood sampling for PK analysis was taken on Day 19.
665764|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
665765|NCT02093351|O1|Outcome|Cohort 1 - Olaparib (Treatment Period 1)|Patients received olaparib 300 mg bd from Day 1 to Day 4, and on Day 5 received olaparib 300 mg once (morning dose only). Blood sampling for PK analysis was taken on Day 5.
665766|NCT02093351|O2|Outcome|Cohort 1 - Olaparib + Tamoxifen (Treatment Period 3)|Patients in Cohort 1 received tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days from Day 27 to Day 31. Blood sampling for PK analysis was taken on Day 31.
665767|NCT02093351|O1|Outcome|Cohort 1 - Tamoxifen Alone (Treatment Period 2)|Patients in Cohort 1 received tamoxifen 60 mg od from Day 10 to Day 13 (loading dose). From Day 14 to Day 26 patients received tamoxifen 20 mg od (maintenance dose). Blood sampling for PK analysis was taken on Day 26.
665768|NCT02093351|E3|Reported Event|Cohort 3 - Letrozole|Patients in Cohort 3 received olaparib 300 mg bd for 5 days in Treatment Period 1; letrozole 2.5 mg od for 29 days in Treatment Period 2; and letrozole 2.5 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665769|NCT02093351|E2|Reported Event|Cohort 2 - Anastrozole|Patients in Cohort 2 received olaparib 300 mg bd for 5 days in Treatment Period 1; anastrozole 1 mg od for 10 days in Treatment Period 2; and anastrozole 1 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665770|NCT02093351|E1|Reported Event|Cohort 1 - Tamoxifen|Patients in Cohort 1 received olaparib 300 mg twice daily (bd) for 5 days in Treatment Period 1; tamoxifen 60 mg once daily (od) (loading dose) for 4 days then 20 mg od for 13 days (maintenance dose) in Treatment Period 2; and tamoxifen 20 mg od concomitantly with olaparib 300 mg bd for 5 days in Treatment Period 3.
665771|NCT02093234|B4|Baseline|Total|Total of all reporting groups
665772|NCT02093234|B3|Baseline|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
665773|NCT02093234|B2|Baseline|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
665774|NCT02093234|B1|Baseline|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
665775|NCT02093234|P3|Participant Flow|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
665776|NCT02093234|P2|Participant Flow|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
665777|NCT02093234|P1|Participant Flow|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
665778|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
665779|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
665780|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
665841|NCT02092857|B1|Baseline|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
688060|NCT01937130|O3|Outcome|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
665781|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
665846|NCT02092857|O2|Outcome|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
665782|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
665783|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
665784|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
665785|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
665786|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
665787|NCT02093234|O3|Outcome|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
665788|NCT02093234|O2|Outcome|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
665789|NCT02093234|O1|Outcome|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
665790|NCT02093234|E3|Reported Event|CHWs and Mobile Health Care Application|"Patients will receive assistance in managing their health from both CHWs and the mobile health cell phone application~CHWs and mobile health care application: CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application."
665791|NCT02093234|E2|Reported Event|Community Health Worker (CHW)|"CHWs assist study patients in managing there health care in various ways.~Community Health Worker (CHW): CHWs assist patients in managing their diabetes in various ways."
665792|NCT02093234|E1|Reported Event|Mobile Health Care Application|"Patients will be assisted with managing their health by a cell phone application used to promote self care for patients with diabetes.~mobile health care application: mobile health application for cell phones to assist patients in managing their diabetes."
665793|NCT02093026|B1|Baseline|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665794|NCT02093026|P1|Participant Flow|Rituximab|Participants received rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (>=) 5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665795|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665796|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665842|NCT02092857|P3|Participant Flow|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
665847|NCT02092857|O1|Outcome|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
665848|NCT02092857|E3|Reported Event|Infant Formula Without Arachidonic Acid|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
665797|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665798|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665799|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665800|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665801|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665802|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665803|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665804|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665843|NCT02092857|P2|Participant Flow|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
665844|NCT02092857|P1|Participant Flow|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
665805|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665806|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665807|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665808|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665809|NCT02093026|O1|Outcome|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665810|NCT02093026|E2|Reported Event|Placebo|Data for participants who received placebo in Study WA17043 or WA16291 are included in this reporting group for data collected until they received their first dose of rituximab in this study (Study WA16855). Data from these participants collected after the first dose of rituximab are included in the rituximab reporting group.
665811|NCT02093026|E1|Reported Event|Rituximab|Participants received rituximab 1 gram IV on Days 1 and 15 of each course of retreatment. In addition, participants received methotrexate 10-25 mg/week orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid >=5 mg/week or equivalent. Participants received retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first [Day 1] infusion of the last course of rituximab). Repeat treatment was based on the investigator’s decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints >=2.6). Retreatment with rituximab was continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever occurred earlier.
665812|NCT02092961|B4|Baseline|Total|Total of all reporting groups
665813|NCT02092961|B3|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
665814|NCT02092961|B2|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
665815|NCT02092961|B1|Baseline|FOSTA 100 MG PO BID|Dosing Group A
665816|NCT02092961|P3|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
665817|NCT02092961|P2|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
665818|NCT02092961|P1|Participant Flow|FOSTA 100 MG PO BID|Dosing Group A
665819|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
665820|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
665821|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
665822|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
665823|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
665824|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
665825|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
665826|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
665827|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
665828|NCT02092961|O3|Outcome|PLACEBO (6 WKS) THEN FOSTA 100 MG PO BID|Dosing Group E
665829|NCT02092961|O2|Outcome|ADALIMUMAB 40 MG SC|Dosing Group D
665830|NCT02092961|O1|Outcome|FOSTA 100 MG PO BID|Dosing Group A
665849|NCT02092857|E2|Reported Event|25 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 25 mg/100 kcal of arachidonic acid
665850|NCT02092857|E1|Reported Event|34 mg/100 kcal Arachidonic Acid|10 weeks exclusive feeding with infant formula containing 34 mg/100 kcal of arachidonic acid
665851|NCT02092662|B3|Baseline|Total|Total of all reporting groups
665852|NCT02092662|B2|Baseline|Control|healthy volunteers
665853|NCT02092662|B1|Baseline|Study|patients after a stroke
665854|NCT02092662|P2|Participant Flow|Control|Healthy voluntiers
665855|NCT02092662|P1|Participant Flow|Patients After a Stroke|Patients who admitted to the hospital for rehabilitation after a stroke
665856|NCT02092662|O2|Outcome|Healthy Controls|"healthy age-matched voluntiers~Healthy controls: no treatment~Deltoid onset time 0.79 sec"
665857|NCT02092662|O1|Outcome|Stroke|"Stroke patients at the subacute phase~stroke: task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context."
665858|NCT02092662|O2|Outcome|Control|Healthy age-matched
665859|NCT02092662|O1|Outcome|Study Group (T1)|Patients after a stroke
665860|NCT02092662|E1|Reported Event|Study|Patients after a stroke
665861|NCT02092649|B3|Baseline|Total|Total of all reporting groups
665862|NCT02092649|B2|Baseline|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665863|NCT02092649|B1|Baseline|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665864|NCT02092649|P2|Participant Flow|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665865|NCT02092649|P1|Participant Flow|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665866|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665867|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665868|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665869|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665870|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665871|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665872|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665873|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665874|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665875|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665876|NCT02092649|O2|Outcome|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665877|NCT02092649|O1|Outcome|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665878|NCT02092649|E2|Reported Event|Placebo Pill|"Oral ingestion of 3 capsules of a placebo olive oil pill (Swanson Health Products, PO Box 2803 - Fargo, ND 58108 USA) per day for 12 weeks.~Placebo Pill"
665879|NCT02092649|E1|Reported Event|Omega-3 Complete|"Oral ingestion of 3000 mg (5 capsules) of Omega-3 Complete (Jamieson Laboratories Ltd., Windsor, Ontario, Canada) per day for 12 weeks.~Omega-3 Complete"
665880|NCT02092610|B3|Baseline|Total|Total of all reporting groups
665881|NCT02092610|B2|Baseline|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
665882|NCT02092610|B1|Baseline|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
665883|NCT02092610|P2|Participant Flow|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
688061|NCT01937130|O2|Outcome|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
665884|NCT02092610|P1|Participant Flow|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
665984|NCT02091986|P2|Participant Flow|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665985|NCT02091986|P1|Participant Flow|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665885|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
665886|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
665887|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
665888|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
665889|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
665890|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
665891|NCT02092610|O2|Outcome|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
665892|NCT02092610|O1|Outcome|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
665893|NCT02092610|E2|Reported Event|Novel Implant BI300|"The product was the novel titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.~Novel Implant BI300: The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long."
665894|NCT02092610|E1|Reported Event|Standard Implant BI300|"The product was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long~Standard Implant BI300: The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long"
665895|NCT02092441|B3|Baseline|Total|Total of all reporting groups
665896|NCT02092441|B2|Baseline|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
665897|NCT02092441|B1|Baseline|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
665898|NCT02092441|P2|Participant Flow|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
665899|NCT02092441|P1|Participant Flow|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
665900|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
665901|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
665902|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
665903|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
665904|NCT02092441|O2|Outcome|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
665905|NCT02092441|O1|Outcome|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
665906|NCT02092441|E2|Reported Event|Normal Saline Prep Pad|"normal saline prep pad~Normal Saline prep pad: Subjects inhale scent of placebo (normal saline) pads"
665907|NCT02092441|E1|Reported Event|Alcohol Prep Pad Group|"isopropyl alcohol prep pad~Alcohol prep pad group: Subjects inhale scent of alcohol pad"
665908|NCT02092415|B1|Baseline|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
665909|NCT02092415|P1|Participant Flow|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
665981|NCT02091986|B2|Baseline|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665910|NCT02092415|O2|Outcome|Normal Subjects - Tourniquet Flow|Perfusion measured at time of tourniquet placement
665911|NCT02092415|O1|Outcome|Normal Subjects Baseline Flow|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
665912|NCT02092415|E1|Reported Event|Normal Subjects|"Normal subjects, all of whom undergo brief application of junctional tourniquet~Application of a Junctional Tourniquet: All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery."
665913|NCT02092389|B1|Baseline|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665914|NCT02092389|P1|Participant Flow|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665915|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665916|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665917|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665918|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665919|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665920|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665921|NCT02092389|O1|Outcome|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665922|NCT02092389|E1|Reported Event|Moderate to Severe Ulcerative Colitis|Patients with moderate to severe ulcerative colitis (UC) who have not responded despite a full and adequate course of therapy with a corticosteroid and an immunosuppressant (azathioprine [AZA]/ 6-mercaptopurine [6-MP]); or who are intolerant to or have medical contraindications for such therapies and are hence prescribed adalimumab for the treatment of moderate to severely active UC.
665923|NCT02092350|B3|Baseline|Total|Total of all reporting groups
665924|NCT02092350|B2|Baseline|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665925|NCT02092350|B1|Baseline|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
665926|NCT02092350|P2|Participant Flow|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a fixed dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665927|NCT02092350|P1|Participant Flow|Immediate Treatment + Intensive PK|Participants received grazoprevir (GZR) 100 mg tablet + elbasvir (EBR) 50 mg tablet once daily (q.d.) by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive pharmacokinetics (PK) testing.
665928|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665929|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
665930|NCT02092350|O2|Outcome|Deferred Treatment Group|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665931|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
665986|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
665987|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
665932|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665933|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
665934|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665935|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
665936|NCT02092350|O2|Outcome|Deferred Treatment|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks. Then, after a 4-week drug-free period, participants received a FDC tablet containing GZR 100 mg + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665937|NCT02092350|O1|Outcome|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
665938|NCT02092350|E3|Reported Event|Deferred Treatment: GZR 100 mg + EBR 50 mg 12 Weeks|Participants received a FDC tablet containing GZR 100 mg + EBR 50 mg q.d. by mouth for 12 weeks, followed by a 24-week follow-up period.
665939|NCT02092350|E2|Reported Event|Deferred Treatment: GZR Placebo + EBR Placebo 12 Weeks|Participants received placebo to GZR and EBR q.d. by mouth for 12 weeks, followed by a 4-week drug-free period.
665940|NCT02092350|E1|Reported Event|Immediate Treatment + Intensive PK|Participants received GZR 100 mg tablet + EBR 50 mg tablet q.d. by mouth for 12 weeks, followed by a 24-week follow-up period. A subset of participants also underwent intensive PK testing.
665941|NCT02092311|B3|Baseline|Total|Total of all reporting groups
665942|NCT02092311|B2|Baseline|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
665943|NCT02092311|B1|Baseline|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
665944|NCT02092311|P2|Participant Flow|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
665945|NCT02092311|P1|Participant Flow|Combined Microscopic Varicocelectomy|Combined Mini-Incision Microscopic Varicocelectomy
665946|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
665947|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
665948|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
665949|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
665950|NCT02092311|O2|Outcome|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
665951|NCT02092311|O1|Outcome|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
665952|NCT02092311|E2|Reported Event|Inguinal and Subinguinal Varicocelectomy|Patients in this arm have the same including criteria as Experimental arm but they were operated with conventional and currently popular approach of Microscopic Inguinal and Sub inguinal varicocelectomy suggested by Goldstien and associate
665953|NCT02092311|E1|Reported Event|Combined Microscopic Varicocelectomy|Patients underwent Combined Mini-incision Microscopic Varicocelectomy
665954|NCT02092168|B3|Baseline|Total|Total of all reporting groups
665955|NCT02092168|B2|Baseline|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
665956|NCT02092168|B1|Baseline|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
665957|NCT02092168|P2|Participant Flow|BIA 9-1067 30 mg (QD) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Young Subjects"
665958|NCT02092168|P1|Participant Flow|BIA 9-1067 30 mg (QD) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (QD) - Elderly Subjects"
665959|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
665960|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
665961|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
665962|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
665963|NCT02092168|O2|Outcome|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
665964|NCT02092168|O1|Outcome|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
665965|NCT02092168|E2|Reported Event|BIA 9-1067 30 mg (Once Daily) - Young Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Young Subjects"
665966|NCT02092168|E1|Reported Event|BIA 9-1067 30 mg (Once Daily) - Elderly Subjects|"BIA 9-1067 was administered as oral doses of 30 mg (5 and 25 mg capsules), once-daily in the morning, during 7 days.~BIA 9-1067 30 mg (once daily) - Elderly Subjects"
665967|NCT02092116|B3|Baseline|Total|Total of all reporting groups
665968|NCT02092116|B2|Baseline|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
665969|NCT02092116|B1|Baseline|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
665970|NCT02092116|P2|Participant Flow|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
665971|NCT02092116|P1|Participant Flow|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
665972|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
665973|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
665974|NCT02092116|O1|Outcome|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
665975|NCT02092116|O1|Outcome|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of 3 romidepsin infusions (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
665976|NCT02092116|O1|Outcome|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
665977|NCT02092116|E2|Reported Event|Part B|"Pre-treatment phase of 2-4 weeks (Visit 1-Visit 2) followed by a therapeutic HIV-1 immunization phase of 12 weeks (Visit 2 to Visit 7) in which 1.2 mg Vacc-4x was administered together with 0.06 mg rhuGM-CSF at Visits 2, 3, 4, 5, 6 and 7 follow by a follow-up period of 2 weeks (Visit 8).~A viral reactivation phase of 3 weeks (Visit 9-Visit 11) consisting of one cycle of romidepsin infusion (5 mg/m2) followed by a post-treatment observation phase of ~9 weeks (Visit 12-Visit 13) to assess the effect of the investigational treatment on the size of the latent HIV-1 reservoir.~A monitored antiretroviral pause of up to 16 weeks (Visit 14-Visit 33)."
665978|NCT02092116|E1|Reported Event|Part A|"Pre-treatment phase of 2-4 weeks (Visit 1- Visit 2a) followed by viral reactivation phase of 3 weeks (Visit 2 to Visit 7) consisting of one cycle of romidepsin infusions at a dosing of 5 mg/m2 on days 0, 7, and 14.~Post-activation phase of ~9 weeks (Visit 8 to Visit 11) to assess the effect of romidepsin on the size of latent HIV-1 reservoir."
665979|NCT02091986|B4|Baseline|Total|Total of all reporting groups
665980|NCT02091986|B3|Baseline|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
665982|NCT02091986|B1|Baseline|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665983|NCT02091986|P3|Participant Flow|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
665989|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
665990|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
665991|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665992|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
665993|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
665994|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665995|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
665996|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
665997|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
665998|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
665999|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666000|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666001|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666002|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666003|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666004|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666005|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666006|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666007|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666008|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666009|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666010|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666011|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666012|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666013|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666014|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666015|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666016|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666017|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666018|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666019|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666020|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666021|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666022|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666023|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666024|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666025|NCT02091986|O3|Outcome|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666026|NCT02091986|O2|Outcome|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/2.25 ug x 2 BID
666027|NCT02091986|O1|Outcome|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666028|NCT02091986|E3|Reported Event|Budesonide pMDI 80 ug|Budesonide pMDI 80 ug x 2 BID
666029|NCT02091986|E2|Reported Event|Symbicort pMDI 80/2.25 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666030|NCT02091986|E1|Reported Event|Symbicort pMDI 80/4.5 ug|Symbicort pMDI 80/4.5 ug x 2 BID
666031|NCT02091869|B3|Baseline|Total|Total of all reporting groups
666032|NCT02091869|B2|Baseline|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
666033|NCT02091869|B1|Baseline|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
666034|NCT02091869|P2|Participant Flow|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
666035|NCT02091869|P1|Participant Flow|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
666036|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
666037|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
666038|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
666073|NCT02091778|O1|Outcome|Fast Gelling Dressing|Fast gelling dressing
688062|NCT01937130|O1|Outcome|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
666039|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
666040|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
666079|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666041|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
666042|NCT02091869|O2|Outcome|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
666043|NCT02091869|O1|Outcome|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
666044|NCT02091869|E2|Reported Event|Mobile Phone|"Participants will record asthma symptoms, medication usage, and peak flow data on their phones.~Mobile Phone: Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app."
666045|NCT02091869|E1|Reported Event|Paper Asthma Action Plan|"Participants will utilize a paper-based asthma action plan to record asthma symptoms, peak flows, and medication usage.~Paper Asthma Action Plan: Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage."
666046|NCT02091856|B4|Baseline|Total|Total of all reporting groups
666047|NCT02091856|B3|Baseline|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666048|NCT02091856|B2|Baseline|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666049|NCT02091856|B1|Baseline|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666050|NCT02091856|P3|Participant Flow|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666051|NCT02091856|P2|Participant Flow|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666052|NCT02091856|P1|Participant Flow|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
666053|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666054|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666055|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
666056|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666074|NCT02091778|E1|Reported Event|Fast Gelling Dressing|Fast gelling dressing
666075|NCT02091752|B1|Baseline|Ruxolitinib|All participants received ruxolitinib.
666076|NCT02091752|P1|Participant Flow|Ruxolitinib|All participants received ruxolitinib.
666077|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666078|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666080|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666081|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666082|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666083|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666084|NCT02091752|O1|Outcome|Ruxolitinib|All participants received ruxolitinib.
666085|NCT02091752|E1|Reported Event|Ruxolitinib|All participants received ruxolitinib.
666057|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666058|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
666059|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666060|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666061|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
666062|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666063|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666064|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
666065|NCT02091856|O3|Outcome|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666066|NCT02091856|O2|Outcome|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666067|NCT02091856|O1|Outcome|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
666068|NCT02091856|E3|Reported Event|Wait List Control Group (WLCG)|This arm represents the wait-list comparison group.
666069|NCT02091856|E2|Reported Event|Religious CBT (R-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief."
666070|NCT02091856|E1|Reported Event|Conventional-CBT (C-CBT)|"This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.~Cognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm."
666071|NCT02091778|B1|Baseline|Fast Gelling Dressing|Fast gelling dressing
666072|NCT02091778|P1|Participant Flow|Fast Gelling Dressing|Fast gelling dressing
666086|NCT02091726|B1|Baseline|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666087|NCT02091726|P1|Participant Flow|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666088|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666089|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666090|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666091|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666092|NCT02091726|O1|Outcome|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666093|NCT02091726|E1|Reported Event|Unicirc With Tissue Adhesive|"Circumcision with Unicirc instrument, followed by wound sealing with cyanoacrylate~Unicirc instrument plus cyanoacrylate tissue adhesive: Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive"
666094|NCT02091466|B3|Baseline|Total|Total of all reporting groups
666095|NCT02091466|B2|Baseline|Control|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
666096|NCT02091466|B1|Baseline|Pre-warming|Eligible participants were pregnant women between 18 and 40 years of age, with singleton pregnancy and gestation longer than 37 weeks, scheduled for elective cesarean section
666097|NCT02091466|P2|Participant Flow|Control|patients were under passive heating in control groups before anesthesia
666098|NCT02091466|P1|Participant Flow|Pre-warming|"patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
666099|NCT02091466|O2|Outcome|Control|Patients remained without the use of a thermal gown,
666100|NCT02091466|O1|Outcome|Pre-warming|Patients were covered with a thermal gown (Bair Paws Standard Warming Gown 810 model with a Bair Hugger, model 850 warming unit) with forced-air flow at 40ºC in the preoperative care unit 30 minutes before the spinal anesthesia.
666101|NCT02091466|E2|Reported Event|Control|Patients were under passive heating in control groups before anesthesia
666102|NCT02091466|E1|Reported Event|Pre-warming|"Patients were under heating system in experimental groups~heating system pre-warming: warming 30 minutes prior to anesthesia"
666103|NCT02091414|B1|Baseline|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666104|NCT02091414|P1|Participant Flow|Mycophenolate Mofetil (MMF) Plus (+) Cyclosporine A (CsA)|Participants received MMF 1.0 grams (g), capsules orally (PO), twice daily (BID) from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 milligrams per kilogram (mg/kg) PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 nanograms per milliliter (ng/mL) through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666105|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666106|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666107|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666108|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666165|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666109|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666110|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666111|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666112|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666113|NCT02091414|O1|Outcome|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666114|NCT02091414|E1|Reported Event|MMF + CsA|Participants received MMF 1.0 g, capsules PO, BID from within 24 hours of transplantation through Week 24. Participants also received an initial loading dose of CsA 4 to 6 mg/kg PO within 48 hours of transplantation, with dose adjustments thereafter as necessary to achieve a blood trough concentration of 150 to 300 ng/mL through Week 24. Participants also received corticosteroids as per the practice of each participating center.
666115|NCT02090855|B1|Baseline|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered.
666116|NCT02090855|P1|Participant Flow|Flutemetamol (18F)|There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. No drug was administered. Subjects were previously dosed in Study GE-067-007.
666117|NCT02090855|O1|Outcome|Percentage of Specificity for Normal Reads|This is the percentage of Specificity with the normal image interpretations.
666118|NCT02090855|O1|Outcome|Percentage of Sensitivity With Abnormal Reads|This is the percent of sensitivity with the Abnormal image interpretations.
666119|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 30 image interpretations when combining normal and abnormal readings.The Standard of Truth (SoT) is based on no/sparse neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria based on specimens stained with the Bielschowsky silver stain.
666120|NCT02090855|O1|Outcome|Standard of Truth (SoT)|Each Reader will have a total of 76 image interpretations when combining normal and abnormal readings.The Standard of Truth is based on moderate/frequent neuritic (amyloid) plaques, per modified Consortium to Establish a Registry for Alzheimer’s Disease (CERAD) criteria, based on specimens stained with the Bielschowsky silver stain.
666121|NCT02090855|E1|Reported Event|Flutemetamol (18F)|This study was to assess the PET images only. There was no drug administered in this study.
666122|NCT02090777|B1|Baseline|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
666123|NCT02090777|P1|Participant Flow|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
666124|NCT02090777|O1|Outcome|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
666125|NCT02090777|E1|Reported Event|Health Coach|"Health Coach is conducted to see if it improves ophthalmic care for glaucoma patients.~Health Coach"
666126|NCT02090764|B3|Baseline|Total|Total of all reporting groups
666127|NCT02090764|B2|Baseline|Placebo|"Placebo cream~Placebo"
666128|NCT02090764|B1|Baseline|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
666129|NCT02090764|P2|Participant Flow|Placebo|"Placebo cream~Placebo"
666130|NCT02090764|P1|Participant Flow|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
666131|NCT02090764|O2|Outcome|Placebo|"Placebo cream~Placebo"
666132|NCT02090764|O1|Outcome|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
666133|NCT02090764|E2|Reported Event|Placebo|"Placebo cream~Placebo"
666134|NCT02090764|E1|Reported Event|Ozenoxacin|"ozenoxacin cream 1%~Ozenoxacin"
666135|NCT02090413|B4|Baseline|Total|Total of all reporting groups
666136|NCT02090413|B3|Baseline|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666137|NCT02090413|B2|Baseline|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666138|NCT02090413|B1|Baseline|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666139|NCT02090413|P3|Participant Flow|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666221|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
707921|NCT01806857|O2|Outcome|Matching Placebo|
666140|NCT02090413|P2|Participant Flow|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666141|NCT02090413|P1|Participant Flow|DMF + ASA-Placebo BID|Dimethyl fumarate (DMF) 120 mg taken twice daily (BID) for the first 7 days and 240 mg BID from Week 2 through Week 48. Acetylsalicylic acid (ASA)-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666142|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666143|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666144|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666145|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666146|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666147|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666148|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666149|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666150|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666151|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666152|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666153|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666154|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666155|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666156|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666157|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666158|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666159|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666160|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666161|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666162|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666163|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666215|NCT02090088|P1|Participant Flow|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666164|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666166|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666167|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666168|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666169|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666170|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666171|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666172|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666173|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666174|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666175|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666176|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666177|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666178|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666179|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666180|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666181|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666182|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666183|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666184|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666185|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666186|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666187|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666188|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666216|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
688063|NCT01937130|E4|Reported Event|Placebo|"Dosed twice daily~Placebo"
666189|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666190|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666191|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666192|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666193|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666194|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666195|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666196|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666197|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666198|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666199|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666200|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666201|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666202|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666203|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666204|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666205|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666206|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666207|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666208|NCT02090413|O3|Outcome|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666209|NCT02090413|O2|Outcome|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666210|NCT02090413|O1|Outcome|DMF + ASA-Placebo BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666211|NCT02090413|E3|Reported Event|DMF + ASA 150 mg BID|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 150 mg BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666212|NCT02090413|E2|Reported Event|DMF + ASA 75 mg QAM|DMF 120 mg BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA 75 mg QAM and ASA-Placebo in the evening from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666213|NCT02090413|E1|Reported Event|DMF + ASA-Placebo BID|DMF 120 mg taken BID for the first 7 days and 240 mg BID from Week 2 through Week 48. ASA-Placebo taken BID from Day 1 through Week 4. (Between Weeks 5 and 8, ASA was prohibited; between Weeks 9 and 48, ASA was allowed as needed.)
666214|NCT02090088|B1|Baseline|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
689289|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
666217|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666218|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666219|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666220|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666222|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666223|NCT02090088|O1|Outcome|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666224|NCT02090088|E2|Reported Event|Infants|Infants who were born to enrolled participants during the study.
666225|NCT02090088|E1|Reported Event|All Participants|Pregnant woman who had any exposure to Nplate® at any time during pregnancy.
666226|NCT02089737|B1|Baseline|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
666227|NCT02089737|P1|Participant Flow|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
666228|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
666229|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
666230|NCT02089737|O1|Outcome|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
666231|NCT02089737|E2|Reported Event|Concomitant Administration of Panitumumab and Chemotherapy|
666232|NCT02089737|E1|Reported Event|Panitumumab|Panitumumab 6 mg/kg, intravenous drip infusion over a 60-minute period, once every 2 weeks for up to 42 weeks
666233|NCT02089347|B3|Baseline|Total|Total of all reporting groups
666234|NCT02089347|B2|Baseline|DT Group|Participants received DT vaccine subcutaneously
666235|NCT02089347|B1|Baseline|SP306 Group|Participants received SP306 vaccine intramuscularly
666236|NCT02089347|P2|Participant Flow|DT Group|Participants received DT vaccine subcutaneously
666237|NCT02089347|P1|Participant Flow|SP306 Group|Participants received SP306 vaccine intramuscularly
666238|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666239|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666240|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666241|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666242|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666243|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666244|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666245|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666246|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666247|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666248|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666249|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666250|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666251|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666252|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666253|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666254|NCT02089347|O2|Outcome|DT Group|Participants received DT vaccine subcutaneously
666255|NCT02089347|O1|Outcome|SP306 Group|Participants received SP306 vaccine intramuscularly
666256|NCT02089347|E2|Reported Event|DT Group|Participants received DT vaccine subcutaneously
666257|NCT02089347|E1|Reported Event|SP306 Group|Participants received SP306 vaccine intramuscularly
666258|NCT02089191|B1|Baseline|Overall|Nelfilcon A and stenfilcon A contact lenses worn for 12 hours each in Period 1 and 2 as randomized
666259|NCT02089191|P2|Participant Flow|MyDay/DACP|Stenfilcon A contact lenses worn in Period 1, followed by nelfilcon A contact lenses in Period 2
666260|NCT02089191|P1|Participant Flow|DACP/MyDay|Nelfilcon A contact lenses worn in Period 1, followed by stenfilcon A contact lenses in Period 2
666261|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
666262|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
666263|NCT02089191|O2|Outcome|MyDay|Stenfilcon A contact lenses
666264|NCT02089191|O1|Outcome|DACP|Nelfilcon A contact lenses
666265|NCT02089191|E2|Reported Event|MyDay|Stenfilcon A contact lenses
666266|NCT02089191|E1|Reported Event|DACP|Nelfilcon A contact lenses
666267|NCT02089113|B3|Baseline|Total|Total of all reporting groups
666268|NCT02089113|B2|Baseline|PVPP (Placebo Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing no drug~Punctum Plug"
666269|NCT02089113|B1|Baseline|OTX-DP (Dexamethasone Punctum Plug)|"Resorbable hydrogel drug delivery vehicle containing dexamethasone~Dexamethasone"
666270|NCT02089113|P2|Participant Flow|Placebo Vehicle Punctum Plug|No drug treatment
666271|NCT02089113|P1|Participant Flow|Dexamethasone Punctum Plug|Drug treatment
666272|NCT02089113|O2|Outcome|Placebo Vehicle Punctum Plug|No drug treatment
666273|NCT02089113|O1|Outcome|Dexamethasone Punctum Plug|Drug treatment
666274|NCT02089113|E2|Reported Event|Placebo Vehicle Punctum Plug|No drug treatment
666275|NCT02089113|E1|Reported Event|Dexamethasone Punctum Plug|Drug treatment
666305|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666627|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666306|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
666307|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666308|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666309|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
666276|NCT02088957|B1|Baseline|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666277|NCT02088957|P2|Participant Flow|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666278|NCT02088957|P1|Participant Flow|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666279|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666280|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666281|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666282|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666283|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666284|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666285|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666303|NCT02087943|O1|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 30 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 30 mg apremilast tablets twice daily in the active treatment phase.
693106|NCT01904773|E1|Reported Event|Overall Study|Part 1 & Part 2
666286|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666287|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666288|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666289|NCT02088957|O2|Outcome|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666290|NCT02088957|O1|Outcome|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666291|NCT02088957|E2|Reported Event|Phenytoin|"Subjects will receive an acute intravenous (iv) dose of Phenytoin (PHT) 20 mg/kg at a rate of 50 mg/min on Day 1. If seizures recur, a second acute dose of PHT iv will be given no sooner than 15 minutes after the first dose. Treatment with PHT iv will be continued with at least 2 daily divided doses according to site practice. Daily PHT dose can be adapted according to investigator's clinical judgment. On study Day 5 (or earlier), subjects will transition from iv to oral formulation at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666292|NCT02088957|E1|Reported Event|Brivaracetam|"Subjects will receive an acute intravenous (iv) dose of Brivaracetam (BRV) 200 mg as a bolus on Day 1. If seizures recur, a second iv bolus of BRV 100 mg can be given no sooner than 15 minutes after the first bolus. If the second acute bolus is not needed within12 hours after first iv bolus, BRV will be continued as 100 mg iv dose every 12 hours (bid). The total dose for the first 24 hours of treatment should not exceed a maximum dose of 400 mg. The rate of bolus administration is 50 mg (5 mL) undiluted BRV/min. On study Day 5 (or earlier), subjects will transition from iv to oral formulation, at comparable dosing for a maximum of 6 months.~Subjects should transition to oral medication as soon as they are able to swallow tablets."
666293|NCT02087943|B4|Baseline|Total|Total of all reporting groups
666294|NCT02087943|B3|Baseline|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666295|NCT02087943|B2|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666296|NCT02087943|B1|Baseline|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
666297|NCT02087943|P5|Participant Flow|Placebo/Apremilast 40 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 40 mg apremilast for 12 weeks, up to week 24.
666298|NCT02087943|P4|Participant Flow|Placebo/Apremilast 30 mg|Participants initially randomized to identically matching placebo tablets twice daily and were re-randomized at Week 12 to 30 mg apremilast for 12 weeks, up to week 24.
666299|NCT02087943|P3|Participant Flow|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 40 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase.
666300|NCT02087943|P2|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 24 in the active treatment phase
666301|NCT02087943|P1|Participant Flow|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
666302|NCT02087943|O2|Outcome|Apremilast 40 mg|Participants initially randomized to 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase and continued receiving 40 mg apremilast tablets twice daily (BID) up to Week 24 in the active treatment phase, and for participants who were initially randomized to placebo and at week 12 subsequently randomized to 40 mg apremilast tablets twice daily in the active treatment phase.
666304|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666310|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666311|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666312|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
666313|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666314|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666315|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
666316|NCT02087943|O3|Outcome|Apremilast 40 mg|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666317|NCT02087943|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666318|NCT02087943|O1|Outcome|Placebo|Participants initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
666319|NCT02087943|E5|Reported Event|Apremilast 40 mg (Apremilast Exposure Period) 0-24|Participants who received 40 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
666320|NCT02087943|E4|Reported Event|Apremilast 30 mg (Apremilast Exposure Period) 0-24|Participants who received 30 mg PO BID apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 12 up until Week 24.
666321|NCT02087943|E3|Reported Event|Apremilast 40 mg (Weeks 0-12)|Participants initially randomized to receive 40 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666322|NCT02087943|E2|Reported Event|Apremilast 30 mg (Weeks 0-12)|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled phase.
666323|NCT02087943|E1|Reported Event|Placebo (Weeks 0-12)|Participants initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-12)
666324|NCT02087774|B3|Baseline|Total|Total of all reporting groups
666325|NCT02087774|B2|Baseline|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
666326|NCT02087774|B1|Baseline|Control School|Control School received no intervention.
666327|NCT02087774|P2|Participant Flow|Intervention Group|"Two schools participated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~One intervention school implemented the program with responsibility given to the principal (school-wide group) and the other school asked the individual teachers to implement the program daily (classroom based group).~Physical Activity and Incentives"
666328|NCT02087774|P1|Participant Flow|Control School|Control School received no intervention.
666329|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
666330|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
666331|NCT02087774|O2|Outcome|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
666332|NCT02087774|O1|Outcome|Control School|Control School received no intervention.
666333|NCT02087774|E2|Reported Event|Intervention Group|"Oneparticipated in the intervention which consisted on 6 minutes of exercise a day and incentives like pedometers and physical fitness prizes.~The responsibility was given to the principal to implement the program.~Physical Activity and Incentives"
666334|NCT02087774|E1|Reported Event|Control School|Control School received no intervention.
666335|NCT02087748|B1|Baseline|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
666336|NCT02087748|P1|Participant Flow|1% Diclofenac Sodium Gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours to one leg, and placebo to the other leg.
666337|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours~Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
666338|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours~1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
666339|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6 hour for 48 hours~Placebo: Placebo gel 4gm applied topically Q6 hour for 48 hours"
666340|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours~1% diclofenac sodium gel: Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours"
666341|NCT02087748|O2|Outcome|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
666342|NCT02087748|O1|Outcome|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
666628|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666343|NCT02087748|E2|Reported Event|Placebo|"Placebo gel 4gm applied topically Q6H for 48 hours~Placebo: gel manufactured to mimic Diclofenac sodium1% gel"
666344|NCT02087748|E1|Reported Event|1% Diclofenac Sodium Gel|"Diclofenac sodium 1% gel 4 grams applied topically Q6 hours for 48 hours~1% diclofenac sodium gel"
666345|NCT02087670|B3|Baseline|Total|Total of all reporting groups
666346|NCT02087670|B2|Baseline|Community Based Exercise|educational program and not supervises exercise program
666450|NCT02085161|P2|Participant Flow|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666347|NCT02087670|B1|Baseline|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
666348|NCT02087670|P2|Participant Flow|Community Based Exercise|educational program and not supervises exercise program
666349|NCT02087670|P1|Participant Flow|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
666350|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
666351|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
666352|NCT02087670|O2|Outcome|Community Based Exercise|educational program and not supervises exercise program
666353|NCT02087670|O1|Outcome|Controlled, Supervised Exercise Protocol|"controlled, supervised exercise protocol within a cardiac rehabilitation program~controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program"
666354|NCT02087670|E2|Reported Event|Community Based Exercise|educational program and not supervises exercise program
666355|NCT02087670|E1|Reported Event|Controlled, Supervised Exercise Protocol|controlled, supervised exercise protocol: exercise program within a cardiac rehabilitation program
666356|NCT02087241|B5|Baseline|Total|Total of all reporting groups
666357|NCT02087241|B4|Baseline|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
666358|NCT02087241|B3|Baseline|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666359|NCT02087241|B2|Baseline|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666360|NCT02087241|B1|Baseline|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666361|NCT02087241|P4|Participant Flow|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
666362|NCT02087241|P3|Participant Flow|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666363|NCT02087241|P2|Participant Flow|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666364|NCT02087241|P1|Participant Flow|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666365|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
666366|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666367|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666368|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666369|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
666370|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666371|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666372|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666373|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
666374|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666375|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666376|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666377|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
666378|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666379|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666380|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666381|NCT02087241|O4|Outcome|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5
666382|NCT02087241|O3|Outcome|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666383|NCT02087241|O2|Outcome|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666384|NCT02087241|O1|Outcome|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666385|NCT02087241|E4|Reported Event|Cohort A|AZD1775 125 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21-Day Cycle)/Pemetrexed 400 mg/Carboplatin AUC 5.
666386|NCT02087241|E3|Reported Event|Cohort 3|AZD1775 175 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
693107|NCT01904760|B3|Baseline|Total|Total of all reporting groups
666387|NCT02087241|E2|Reported Event|Cohort 2|AZD1775 225 mg bid. 5 doses over 3 days (Days 3, 4, and 5 of a 21-Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6.
666388|NCT02087241|E1|Reported Event|Cohort 1|AZD1775 225 mg bid. 5 doses over 3 days (Days 1, 2, and 3 of a 21- Day Cycle)/Pemetrexed 500 mg/Carboplatin AUC 6
666542|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
666389|NCT02087176|B1|Baseline|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
666390|NCT02087176|P1|Participant Flow|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
666391|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
666392|NCT02087176|O1|Outcome|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
666393|NCT02087176|E1|Reported Event|Part A: AZD1775 Plus Docetaxel|Six subject safety lead-in followed by single arm cohort. All patients were to receive AZD 1775 plus Docetaxel in 21 day cycles for a maximum of 4 cycles.
666394|NCT02087059|B1|Baseline|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666395|NCT02087059|P1|Participant Flow|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666396|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666397|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666398|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666399|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666400|NCT02087059|O1|Outcome|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666401|NCT02087059|E1|Reported Event|Ruxolitinib|Ruxolitinib was administered orally twice daily at the starting dose of 5 mg, 15 mg or 20 mg bid based on Baseline platelet counts. The dosage was subsequently adjusted for safety and efficacy so that each patient was titrated to their most appropriate dose.
666402|NCT02086708|B1|Baseline|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
666403|NCT02086708|P1|Participant Flow|Shear Wave Sonoelastography, Fibrosis|"Shear Wave sonoelastography is performed on patients who are scheduled for a non-focal liver biopsy.~Shear Wave sonoelastography: Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score from liver biopsy."
666404|NCT02086708|O5|Outcome|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
666405|NCT02086708|O4|Outcome|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
666406|NCT02086708|O3|Outcome|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
666407|NCT02086708|O2|Outcome|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
666408|NCT02086708|O1|Outcome|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
666409|NCT02086708|E5|Reported Event|Fibrosis 4|Patients with liver biopsy METAVIR stage 4 on pathology evaluation
666410|NCT02086708|E4|Reported Event|Fibrosis 3|Patients with liver biopsy METAVIR stage 3 on pathology evaluation
666411|NCT02086708|E3|Reported Event|Fibrosis 2|Patients with liver biopsy METAVIR stage 2 on pathology evaluation
666412|NCT02086708|E2|Reported Event|Fibrosis 1|Patients with liver biopsy METAVIR stage 1 on pathology evaluation
666413|NCT02086708|E1|Reported Event|Fibrosis 0|Patients with no Fibrosis on liver biopsy evaluation
666414|NCT02086591|B1|Baseline|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
666415|NCT02086591|P1|Participant Flow|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
666416|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
666417|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
666418|NCT02086591|O1|Outcome|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
666419|NCT02086591|E1|Reported Event|Doxycycline|"Doxycycline 200 mg twice daily~Doxycycline"
666420|NCT02085785|B3|Baseline|Total|Total of all reporting groups
666421|NCT02085785|B2|Baseline|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
693221|NCT01904279|B3|Baseline|Total|Total of all reporting groups
666449|NCT02085161|P3|Participant Flow|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
668113|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
666422|NCT02085785|B1|Baseline|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
666423|NCT02085785|P2|Participant Flow|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
666424|NCT02085785|P1|Participant Flow|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
666425|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
666426|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
666427|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
666428|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
666429|NCT02085785|O1|Outcome|Self-directed + Coached Combined|Intervention assessment questionnaires were not linked to other study data, so we are unable to report study group information
666430|NCT02085785|O2|Outcome|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
666431|NCT02085785|O1|Outcome|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
666432|NCT02085785|O1|Outcome|Overall Study Feasibility|Reporting of recruitment and eligibility for the targeted population
666433|NCT02085785|E2|Reported Event|Self-directed|"Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group, but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.~Self-directed control group: Participants randomized to the self-directed arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own."
666448|NCT02085161|P4|Participant Flow|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666434|NCT02085785|E1|Reported Event|Coached|"Participants randomized to the coached arm will receive the same educational and self-monitoring materials as the self-directed group. In addition, participants in the coached arm will receive 11 calls from a health coach and a single visit to their home by an exercise specialist.~Coached group: Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur"
666435|NCT02085720|B1|Baseline|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
666436|NCT02085720|P1|Participant Flow|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
666437|NCT02085720|O1|Outcome|Sleep Heatlh Questionnaire Result|We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres.
666438|NCT02085720|O1|Outcome|AHI Result|Subjects who had completed the questionnaires and consented for sleep study were invited to undergo a portable at-home sleep study. In the afternoon, subjects attended the pulmonary function laboratory to be fitted with the EmblettaTM portable diagnostic system (PDS, Medcare, Iceland). It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an AHI based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. Respiratory events were scored when desaturations of at least 4% occurred in the absence of moving artifacts and irrespective of co-existing changes in snoring or heart rate. A hypopnea was defined as a decrease in airflow by 50% of baseline for at least 10 seconds. Data were included in the analysis if the total recorded evaluation time of 4 hrs or longer was obtained during the EmblettaTM PDS study.
666439|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
666440|NCT02085720|O1|Outcome|Chinese Elderly OSAS|RLS is a disorder characterized by disagreeable leg sensations that usually occur before sleep onset, causing an almost irresistible urge to move the legs. As minimal criteria for diagnosis, the following four features were required: (1) desire to move the extremities, often associated with paresthesias and/or dysesthesias; (2) motor restlessness; (3) worsening of symptoms at rest, with at least temporary relief by activity; and (4) worsening of symptoms in the evening or at night.
666441|NCT02085720|O1|Outcome|Chinese Elderly OSAS|"We conducted a sleep questionnaire survey among the elders aged 60 years or more in the community centres followed by level 3 home sleep study (EMBLETTA). Subjects with an apnea hypopnea index (AHI) ≥ 15 alone and those with AHI ≥ 5 plus either cardiovascular risk factors or Epworth Sleepiness Score (ESS) ≥ 10 were offered continuous positive airway pressure (CPAP) treatment.~CPAP therapy: Elderly subjects who agreed for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). Epworth Sleepiness Score (ESS), sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
666442|NCT02085720|E1|Reported Event|Chinese Elderly OSAS|"Subjects will be recruited in the community elderly center with home sleep study done. Those with significant OSAS will be prescribed with CPAP therapy and subsequent compliance is monitored.~CPAP therapy: As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment."
666443|NCT02085161|B5|Baseline|Total|Total of all reporting groups
666444|NCT02085161|B4|Baseline|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666445|NCT02085161|B3|Baseline|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666446|NCT02085161|B2|Baseline|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666447|NCT02085161|B1|Baseline|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666540|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
666451|NCT02085161|P1|Participant Flow|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666452|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666453|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666454|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666455|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666456|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666457|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666458|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666459|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666460|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666461|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666462|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666463|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666464|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666465|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666466|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666467|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666468|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666469|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666470|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666471|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666472|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666473|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666474|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666475|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666476|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666477|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666478|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666479|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
695357|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
666480|NCT02085161|O4|Outcome|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666634|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666481|NCT02085161|O3|Outcome|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666482|NCT02085161|O2|Outcome|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666483|NCT02085161|O1|Outcome|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666484|NCT02085161|E5|Reported Event|Total|Total
666485|NCT02085161|E4|Reported Event|Tio+Olo (5/5 μg) FDC With Exercise Training (ET) and BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks; ET was conducted for 8 weeks.
666486|NCT02085161|E3|Reported Event|Tiotropium + Olodaterol (Olo) (5/5 μg) FDC With BM|Tiotropium 5 μg plus olodaterol 5 μg FDC solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666487|NCT02085161|E2|Reported Event|Tiotropium (Tio) 5 Micro-grams (μg) With BM|Tiotropium 5 μg solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666488|NCT02085161|E1|Reported Event|Placebo With Behavioural Modification (BM)|Placebo matching tiotropium + olodaterol FDC or tiotropium solution was delivered to the patients orally once daily via RESPIMAT inhaler, with BM for 12 weeks.
666489|NCT02084797|B1|Baseline|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
666490|NCT02084797|P1|Participant Flow|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
666491|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
666492|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
666493|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
666512|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666629|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666541|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
666494|NCT02084797|O1|Outcome|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
666495|NCT02084797|E1|Reported Event|1/Placebo, V2R Agonist, V2R Antagonist|"This study was a double-blind randomized controlled trial in which all ten subjects participated in three trials under three separate pharmacological interventions: V2R antagonist, agonist and placebo conditions. A standardized exercise protocol was performed in the laboratory, separated by one week. Each subject served as his or her own control and the key which identified which intervention was utilized in the exact order (all tablets customized to appear identical) was unlocked only after data collection was completed. Therefore, all ten subjects participated in a total of thirty intervention exercise trials after the initial treadmill familiarization trial was completed.~V2R (Vasopressin 2 receptor): All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state)."
666496|NCT02084706|B3|Baseline|Total|Total of all reporting groups
666497|NCT02084706|B2|Baseline|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
666498|NCT02084706|B1|Baseline|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
666499|NCT02084706|P2|Participant Flow|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects will receive a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
666500|NCT02084706|P1|Participant Flow|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects will receive an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
666501|NCT02084706|O2|Outcome|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
666502|NCT02084706|O1|Outcome|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
666503|NCT02084706|E2|Reported Event|J-tip Lidocaine Administration, Then Steroid Injection|"Group two subjects received a needle free J-tip administration of 0.5mL of 2% lidocaine prior (2-10 minutes) to needle injection of 0.5mL of Triamcinolone (20 g) over the A1 pulley.~2% Lidocaine~Triamcinolone (20 g)~J-tip lidocaine administration~Triamcinolone (20 g) Injection over the A1 pulley."
666504|NCT02084706|E1|Reported Event|Triamcinolone (20 g) and 2% Lidocaine Injection Over A1 Pulley|"Group one subjects received an injection of 0.5mL (20 g) of Triamcinolone and 0.5 mL of 2% Lidocaine over the A1 pulley.~Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley~2% Lidocaine~Triamcinolone (20 g)"
666505|NCT02084628|B1|Baseline|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666506|NCT02084628|P1|Participant Flow|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participant to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666507|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666508|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666509|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666510|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666511|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666513|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666514|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666515|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666516|NCT02084628|O1|Outcome|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666517|NCT02084628|E1|Reported Event|Gadoxetate Disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
666518|NCT02084238|B1|Baseline|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease."
666519|NCT02084238|P1|Participant Flow|Interleukin-2|"Interleukin-2 to treat activated SLE.~Interleukin-2: Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day break, another cycle started) for 3-6 courses according to the situation of the disease."
666520|NCT02084238|O1|Outcome|SLEDAI Score|SLEDAI score at week 0 and week 10.
666521|NCT02084238|O3|Outcome|Laboratory Variables 3|Serum anti-dsDNA antibodies in patients with SLE
666522|NCT02084238|O2|Outcome|Laboratory Variables 2|Serum complement 4 in SLE patients
666523|NCT02084238|O1|Outcome|Laboratory Variables 1|Serum complement 3 in SLE patients
666524|NCT02084238|O3|Outcome|Immunological Responses 3|Th17 in CD4+T cells in 23 patients with SLE
666525|NCT02084238|O2|Outcome|Immunological Responses 2|Tfh cells in CD4+ T cells in 23 patients with SLE
666526|NCT02084238|O1|Outcome|Immunological Responses 1|Treg in total CD4+T cells in 23 patients with SLE
666527|NCT02084238|O1|Outcome|SRI Results|All 38 patients who completed therapy will be calculated the response rate at each visit time point(week 2,4,6,8,10).
666528|NCT02084238|E1|Reported Event|IL-2 Therapy in SLE|All enrolled patients completed three cycles of recombinant human IL-2 (rhIL-2). In each cycle, 1 million IU rhIL-2 was administered subcutaneously every other day for 2 weeks, followed by a 2-week break.
666529|NCT02084082|B3|Baseline|Total|Total of all reporting groups
666530|NCT02084082|B2|Baseline|FDC 1000 Fed or L+M 1000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 1000 fed (T fed): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.~L+M 1000 fed (R fed): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
666531|NCT02084082|B1|Baseline|FDC 1000 Fast or L+M 1000 Fast|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 1000 fast (T fasted): 5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 1000 fast (R fasted): 5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
666532|NCT02084082|P4|Participant Flow|L+M1000 Fed/ FDC1000 Fed|"Single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR FDC (given as 1 FDC tablet), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
666533|NCT02084082|P3|Participant Flow|FDC1000 Fed/L+M1000 Fed|"Linagliptin/Metformin XR FDC (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
666534|NCT02084082|P2|Participant Flow|L+M1000 Fast/ FDC1000 Fast|"Single tablets of linagliptin and metformin Extended Release (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) followed by Linagliptin/Metformin XR Fixed Dose Combination (given as 1 FDC tablet), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
666535|NCT02084082|P1|Participant Flow|FDC 1000 Fast/ L+M 1000 Fast|"Linagliptin/Metformin Extended Release (XR) Fixed dose combination (given as 1 FDC tablet) followed by single tablets of linagliptin and metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR), oral with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin 1000mg"
666536|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
666537|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
666538|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
666539|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
666630|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666543|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
666544|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
666545|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
666546|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
666547|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
666548|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
666549|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
666550|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
666551|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
666552|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
666553|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
666554|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
666555|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
666556|NCT02084082|O4|Outcome|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
666557|NCT02084082|O3|Outcome|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
666558|NCT02084082|O2|Outcome|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
666559|NCT02084082|O1|Outcome|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
666560|NCT02084082|E4|Reported Event|FDC 1000 Fed|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after after a high-fat, high-calorie meal.
666561|NCT02084082|E3|Reported Event|L+M 1000 Fed|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after a high-fat, high-calorie meal.
666562|NCT02084082|E2|Reported Event|FDC 1000 Fasted|5 mg linagliptin/1000 mg metformin XR (given as 1 FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.
666563|NCT02084082|E1|Reported Event|L+M 1000 Fasted|5 mg linagliptin and 1000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 2 tablets 500 mg metformin XR) oral with 240 mL of water after an overnight fast of at least 10 h.
666564|NCT02084069|B3|Baseline|Total|Total of all reporting groups
666565|NCT02084069|B2|Baseline|Control|Placebo
666566|NCT02084069|B1|Baseline|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
666567|NCT02084069|P2|Participant Flow|Control|Placebo
666568|NCT02084069|P1|Participant Flow|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
666569|NCT02084069|O2|Outcome|Control|Placebo
666570|NCT02084069|O1|Outcome|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
666571|NCT02084069|E2|Reported Event|Control|Placebo
666572|NCT02084069|E1|Reported Event|Treatment|Atorvastatin 40 mg once daily from 3 days before surgery up to five days after surgery
666573|NCT02084056|B3|Baseline|Total|Total of all reporting groups
666574|NCT02084056|B2|Baseline|FDC 2000 Fed or L+M 2000 Fed|"The subjects in Part 2 were randomly allocated to 1 of the 2 treatment sequences T fed_R fed or R fed_T fed.~FDC 2000 fed (T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after a high-fat, high-calorie meal.~L+M 2000 fed (R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
666575|NCT02084056|B1|Baseline|FDC 2000 Fasted or L+M 2000 Fasted|"The subjects in Part 1 were randomly allocated to 1 of the 2 treatment sequences T fasted_R fasted or R fasted_T fasted.~FDC 2000 fasted (T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) orally with 240 mL of water after an overnight fast of at least 10 h.~L+M 2000 fasted (R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
666604|NCT02084056|E4|Reported Event|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
695795|NCT01886313|B3|Baseline|Total|Total of all reporting groups
666576|NCT02084056|P4|Participant Flow|L+M 2000 Fed / FDC 2000 Fed|"Linagliptin+ Metformin-(R fed): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
666577|NCT02084056|P3|Participant Flow|FDC 2000 Fed / L+M 2000 Fed|"Linagliptin+ Metformin (FDC)-(T fed): 2X2.5 mg linagliptin/1000 mg metformin XR (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after after a high-fat, high-calorie meal.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
666578|NCT02084056|P2|Participant Flow|L+M 2000 Fasted / FDC 2000 Fasted|"Linagliptin+ Metformin-(R fasted): 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR) followed by Linagliptin+ Metformin (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin XR orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
666579|NCT02084056|P1|Participant Flow|FDC 2000 Fasted / L+M 2000 Fasted|"Linagliptin+ Metformin Fixed dose combination (FDC)-(T fasted): 2X2.5 mg linagliptin/1000 mg metformin Extended Release (XR) (given as FDC tablet) followed by 5 mg linagliptin and 2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.~Where, L+M = Linagliptin 5mg+Metformin XR 2000mg"
666580|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
666581|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
666582|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
666583|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
666584|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
666585|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
666586|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
666587|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
666588|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
666589|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
666590|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
666591|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
666592|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
666593|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
666594|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
666595|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
666596|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
666597|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
666598|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
666599|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
666600|NCT02084056|O4|Outcome|FDC 2000 Fed|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after a high-fat, high-calorie meal.
666601|NCT02084056|O3|Outcome|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
666602|NCT02084056|O2|Outcome|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
666603|NCT02084056|O1|Outcome|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
666605|NCT02084056|E3|Reported Event|L+M 2000 Fed|5 mg linagliptin/2000 mg metformin XR given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fed) orally with 240 mL of water after a high-fat, high-calorie meal.
666606|NCT02084056|E2|Reported Event|FDC 2000 Fasted|5 mg linagliptin and 2000 mg metformin XR FDC (given as 2 tablet 2.5 mg linagliptin and 1000 mg metformin XR) orally with 240 mL of water after an overnight fast of at least 10 h.
666607|NCT02084056|E1|Reported Event|L+M 2000 Fasted|5 mg linagliptin/2000 mg metformin XR (given as 1 tablet 5 mg linagliptin and 4 tablets 500 mg metformin XR; R fasted) orally with 240 mL of water after an overnight fast of at least 10 h.
666608|NCT02083965|B3|Baseline|Total|Total of all reporting groups
666609|NCT02083965|B2|Baseline|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
666610|NCT02083965|B1|Baseline|rFVIIIFc 1000 / 3000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
666611|NCT02083965|P2|Participant Flow|rFVIIIFc 3000 / 1000|"Following the minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 3000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of PK assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
666612|NCT02083965|P1|Participant Flow|rFVIIIFc 1000 / 3000|"Following a minimum 4-day washout, participants received a single injection 50 IU/kg at strength of 1000 IU/vial of rFVIIIFc (on Injection 1 Day 1) with 96 hours of pharmacokinetic (PK) assessments followed by a minimum of a 5-day washout prior to a second single injection of rFVIIIFc 50 IU/kg at strength of 3000 IU/vial (on Injection 2 Day 1) with 96 hours of PK assessments.~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate subjects who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
666613|NCT02083965|O1|Outcome|rFVIIIFc|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
666614|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666615|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666616|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666617|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666618|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666619|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666620|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666621|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666622|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666623|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666624|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666625|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666626|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666631|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666632|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666633|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
668114|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
666635|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666636|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666637|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666638|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666639|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666640|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666641|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666642|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666643|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666644|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666645|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666646|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666647|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666648|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666649|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666650|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|rFVIIIFc single injection 50 IU/kg at a strength of 3000 IU/vial
666651|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666652|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666653|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666654|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666655|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666656|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666657|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666658|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666659|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666660|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666661|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666662|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666663|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666664|NCT02083965|O2|Outcome|rFVIIIFc 3000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 3000 IU/vial
666665|NCT02083965|O1|Outcome|rFVIIIFc 1000 IU|a single injection of rFVIIIFc 50 IU/kg at a strength of 1000 IU/vial
666666|NCT02083965|E1|Reported Event|Total Active|"Following the minimum 4-day washout, participants received their first injection of rFVIIIFc (on Injection 1 Day 1) rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial. The second injection of rFVIIIFc 50 IU/kg at a strength of either 1000 or 3000 IU/vial was administered, in a crossover fashion, after a minimum of a 5-day washout (on Injection 2 Day 1).~After completing the PK assessment, all participants began 1 of 3 continued treatment regimens for up to 6 months:~A prophylaxis regimen at a starting dose of 50 IU/kg of rFVIIIFc given every 3 to 5 days; further dose and interval adjustments were based on the Investigator’s discretion as needed to prevent or treat bleeding.~A prophylaxis regimen of 65 IU/kg administered every 7 days was considered for appropriate participants who were selected based on the opinion of the Investigator.~An episodic (on-demand) treatment with rFVIIIFc at 20 to 50 IU/kg, depending on the severity of the bleeding episode."
666667|NCT02083679|B5|Baseline|Total|Total of all reporting groups
666668|NCT02083679|B4|Baseline|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666669|NCT02083679|B3|Baseline|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666670|NCT02083679|B2|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666720|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|"Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined~Artefenomel 800mg: PQP 640mg, 960mg & 1440mg"
666721|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666722|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666671|NCT02083679|B1|Baseline|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666672|NCT02083679|P4|Participant Flow|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666673|NCT02083679|P3|Participant Flow|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666674|NCT02083679|P2|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666675|NCT02083679|P1|Participant Flow|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666676|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666677|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666678|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666679|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666680|NCT02083679|O4|Outcome|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666681|NCT02083679|O3|Outcome|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666682|NCT02083679|O2|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666717|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
666718|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
666719|NCT02083380|O1|Outcome|A) Artefenomel 800mg: PQP 640mg, 960mg & 1440mg|Artefenomel 800mg: Piperaquine phosphate 640mg, 960mg & 1440mg combined
666683|NCT02083679|O1|Outcome|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666684|NCT02083679|E4|Reported Event|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666685|NCT02083679|E3|Reported Event|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666686|NCT02083679|E2|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666687|NCT02083679|E1|Reported Event|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 administered as an intravenous infusion at a dose of 6 milligram per kilogram (mg/kg) weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject met any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 milligram per meter square (mg/m^2) on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
666688|NCT02083406|B4|Baseline|Total|Total of all reporting groups
666689|NCT02083406|B3|Baseline|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
666690|NCT02083406|B2|Baseline|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
666691|NCT02083406|B1|Baseline|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
666692|NCT02083406|P3|Participant Flow|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
666693|NCT02083406|P2|Participant Flow|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
666694|NCT02083406|P1|Participant Flow|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
666695|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
666696|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
666697|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
666698|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
666699|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
666700|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
666701|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
666702|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
666703|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
666704|NCT02083406|O3|Outcome|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
666705|NCT02083406|O2|Outcome|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
666706|NCT02083406|O1|Outcome|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
666707|NCT02083406|E3|Reported Event|Treatment C: OZ439 Prototype 3|800mg OZ439 prototype formulation 3 and 960mg PQP single doses under fasted conditions
666708|NCT02083406|E2|Reported Event|Treatment B: OZ439 Prototype 2|800mg OZ439 prototype formulation 2 and 960mg PQP single doses under fasted conditions
666709|NCT02083406|E1|Reported Event|Treatment A: OZ439 Prototype 1|800mg OZ439 prototype formulation 1 and 960mg PQP single doses under fasted conditions
666710|NCT02083380|B4|Baseline|Total|Total of all reporting groups
666711|NCT02083380|B3|Baseline|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
666712|NCT02083380|B2|Baseline|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
666713|NCT02083380|B1|Baseline|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine 640mg
666714|NCT02083380|P3|Participant Flow|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666715|NCT02083380|P2|Participant Flow|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666716|NCT02083380|P1|Participant Flow|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666723|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666724|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666725|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666726|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666727|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666728|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666729|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666730|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666731|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666732|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666733|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666734|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666735|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666736|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666737|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666738|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666739|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666740|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666741|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666742|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666743|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666744|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666745|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666746|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666747|NCT02083380|O1|Outcome|A) Arttefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666748|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666749|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666750|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666751|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666752|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666753|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666754|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666755|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666756|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666757|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666758|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666759|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666760|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666761|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666762|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666763|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666764|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666765|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666766|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666767|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666768|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666769|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666770|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666771|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
668115|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
666772|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666773|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666774|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666775|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|C) Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666776|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666777|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666778|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666779|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666780|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666781|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666782|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666783|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666784|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666785|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666786|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666787|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666788|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666789|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666790|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666791|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666792|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666793|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666794|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666795|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666796|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666797|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666798|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666799|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666800|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666801|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg loose combination
666802|NCT02083380|O3|Outcome|C) Artefenomel 800mg: Piperaquine 1440mg|Artefenomel 800mg: Piperaquine phosphate 1440mg loose combination
666803|NCT02083380|O2|Outcome|B) Artefenomel 800mg: Piperaquine 960mg|Artefenomel 800mg: Piperaquine phosphate 960mg loose combination
666804|NCT02083380|O1|Outcome|A) Artefenomel 800mg: Piperaquine 640mg|Artefenomel 800mg: piperaquine 640mg: Active, loose combination
666805|NCT02083380|E3|Reported Event|C) Artefenomel 800mg: PQP 1440mg|Artefenomel 800mg: Piperaquine 1440mg
666806|NCT02083380|E2|Reported Event|B) Artefenomel 800mg: PQP 960mg|Artefenomel 800mg: Piperaquine 960mg
666807|NCT02083380|E1|Reported Event|A) Artefenomel 800mg: PQP 640mg|Artefenomel 800mg: Piperaquine phosphate 640mg
666808|NCT02083263|B3|Baseline|Total|Total of all reporting groups
666809|NCT02083263|B2|Baseline|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
666810|NCT02083263|B1|Baseline|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
666811|NCT02083263|P2|Participant Flow|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
666812|NCT02083263|P1|Participant Flow|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
666813|NCT02083263|O2|Outcome|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
666814|NCT02083263|O1|Outcome|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
666815|NCT02083263|E2|Reported Event|PEP Mask|"PEP mask, 3 months~PEP mask: 3 months"
666816|NCT02083263|E1|Reported Event|Bilevel|"Bilevel, 3 months~Bilevel: 3 months"
666817|NCT02083107|B4|Baseline|Total|Total of all reporting groups
666818|NCT02083107|B3|Baseline|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666819|NCT02083107|B2|Baseline|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666820|NCT02083107|B1|Baseline|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666821|NCT02083107|P3|Participant Flow|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666822|NCT02083107|P2|Participant Flow|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666823|NCT02083107|P1|Participant Flow|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666824|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666825|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666826|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666827|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666828|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666829|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666830|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666831|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666832|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666833|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666834|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666835|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666836|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666837|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666838|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666839|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666840|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666841|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666842|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666843|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666844|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666845|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666846|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666847|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666848|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666849|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666850|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666851|NCT02083107|O3|Outcome|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666852|NCT02083107|O2|Outcome|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666853|NCT02083107|O1|Outcome|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
667150|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
666854|NCT02083107|E3|Reported Event|Rectal Misoprostol & Sublingual Placebo|"will receive 400 microgram of misoprostol (Sigma) rectal 2 tablets and sublingual placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666855|NCT02083107|E2|Reported Event|Rectal & Sublingual Placebo|"will receive rectal placebo2 tablets” and sublingual placebo2 tablets”."
666856|NCT02083107|E1|Reported Event|Sublingual Misoprostol & Rectal Placebo|"will receive 400 microgram of misoprostol (Sigma) sublingual 2 tablets and rectal placebo2 tablets.~Misoprostol: Comparison of different routes of administration of 400 micro gram misoprostol"
666857|NCT02082912|B3|Baseline|Total|Total of all reporting groups
666858|NCT02082912|B2|Baseline|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
666859|NCT02082912|B1|Baseline|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
666860|NCT02082912|P2|Participant Flow|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
666861|NCT02082912|P1|Participant Flow|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
666862|NCT02082912|O2|Outcome|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
666863|NCT02082912|O1|Outcome|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
666864|NCT02082912|E2|Reported Event|Placebo|Subjects will take a placebo pill and use the HandMentor Pro for robotic therapy
666865|NCT02082912|E1|Reported Event|D-cycloserine|Subjects will take D-cycloserine and use the HandMentor Pro for robotic therapy
666866|NCT02082769|B4|Baseline|Total|Total of all reporting groups
666867|NCT02082769|B3|Baseline|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
666868|NCT02082769|B2|Baseline|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
666869|NCT02082769|B1|Baseline|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
666870|NCT02082769|P3|Participant Flow|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
666871|NCT02082769|P2|Participant Flow|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
666872|NCT02082769|P1|Participant Flow|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
666873|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
666874|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
666875|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
666876|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
666877|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
666878|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
666879|NCT02082769|O3|Outcome|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
666880|NCT02082769|O2|Outcome|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
666881|NCT02082769|O1|Outcome|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
666882|NCT02082769|E3|Reported Event|Allopurinol 100mg QD|"Allopurinol 100mg, orally, three times daily for up to 24 weeks~Allopurinol"
666883|NCT02082769|E2|Reported Event|Febuxostat 80 mg QD|"Febuxostat 80 mg, orally, once daily for up to 24 weeks~Febuxostat"
666884|NCT02082769|E1|Reported Event|Febuxostat 40 mg QD|"Febuxostat 40 mg, orally, once daily for up to 24 weeks~Febuxostat"
666885|NCT02082288|B1|Baseline|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
666886|NCT02082288|P1|Participant Flow|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
666887|NCT02082288|O1|Outcome|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
666888|NCT02082288|E1|Reported Event|Edessy ICSI Outcome Embryo Score|"Edessy ICSI Outcome Embryo Score: EIOS:~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
666889|NCT02082262|B1|Baseline|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
666890|NCT02082262|P1|Participant Flow|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
666891|NCT02082262|O1|Outcome|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
666892|NCT02082262|E1|Reported Event|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
666893|NCT02082184|B3|Baseline|Total|Total of all reporting groups
666894|NCT02082184|B2|Baseline|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
667060|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
666895|NCT02082184|B1|Baseline|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666896|NCT02082184|P2|Participant Flow|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666897|NCT02082184|P1|Participant Flow|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666898|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666899|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666900|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666901|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666902|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666903|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666904|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666905|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666906|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666907|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666908|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666909|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666910|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666911|NCT02082184|O2|Outcome|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666912|NCT02082184|O1|Outcome|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666913|NCT02082184|E2|Reported Event|Standard Blood Glucose Monitoring|"Subjects randomised to the control group will be given blood glucose meters for monitoring for the 6 months study duration.~Standard Blood Glucose Monitoring: Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666914|NCT02082184|E1|Reported Event|Sensor Based Glucose Monitoring System|"Standard system use for 6 months. Followed by open access to the device for 6 months.~Sensor Based Glucose Monitoring System: Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
666915|NCT02082158|B7|Baseline|Total|Total of all reporting groups
666916|NCT02082158|B6|Baseline|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666917|NCT02082158|B5|Baseline|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666918|NCT02082158|B4|Baseline|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666919|NCT02082158|B3|Baseline|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that model while participating in study activities.~Novel Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666920|NCT02082158|B2|Baseline|Non-Local Respirator Model|"Subjects randomized to a current respirator design will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666966|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666921|NCT02082158|B1|Baseline|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Current Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666922|NCT02082158|P6|Participant Flow|Prototype 4 Respirator Design|"Subjects randomized to Prototype 4 respirator design will wear that model while participating in study activities.~Prototype 4 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666923|NCT02082158|P5|Participant Flow|Prototype 3 Respirator Design|"Subjects randomized to Prototype 3 respirator design will wear that model while participating in study activities.~Prototype 3 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666924|NCT02082158|P4|Participant Flow|Prototype 2 Respirator Design|"Subjects randomized to Prototype 2 respirator design will wear that model while participating in study activities.~Prototype 2 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666925|NCT02082158|P3|Participant Flow|Prototype 1 Respirator Design|"Subjects randomized to Prototype 1 respirator design will wear that model while participating in study activities.~Prototype 1 Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666926|NCT02082158|P2|Participant Flow|Non-Local Respirator Model|"Subjects randomized to the non-local respirator design will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
666927|NCT02082158|P1|Participant Flow|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
666928|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 4 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666929|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 3 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666930|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 2 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666931|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to a novel respirator design will wear that respirator while participating in study activities.~Prototype 1 Respirator Design: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666932|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to a non-local respirator model will wear that model while participating in study activities.~Non-Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
666933|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to a current respirator model will wear that model while participating in study activities.~Local Respirator Model: Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.~Novel Respirator Design"
666934|NCT02082158|O6|Outcome|Prototype 4 Respirator Design|"Subjects randomized to the Prototype 4 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666935|NCT02082158|O5|Outcome|Prototype 3 Respirator Design|"Subjects randomized to the Prototype 3 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666936|NCT02082158|O4|Outcome|Prototype 2 Respirator Design|"Subjects randomized to the Prototype 2 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666937|NCT02082158|O3|Outcome|Prototype 1 Respirator Design|"Subjects randomized to the Prototype 1 respirator design will wear that respirator while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666967|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666938|NCT02082158|O2|Outcome|Non-Local Respirator Model|"Subjects randomized to the non-local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666939|NCT02082158|O1|Outcome|Local Respirator Model|"Subjects randomized to the local respirator model will wear that model while participating in study activities.~Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn."
666940|NCT02082158|E6|Reported Event|Prototype 4 Respirator Design|Subjects randomized to Prototype 4 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
666941|NCT02082158|E5|Reported Event|Prototype 3 Respirator Design|Subjects randomized to Prototype 3 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
666942|NCT02082158|E4|Reported Event|Prototype 2 Respirator Design|Subjects randomized to Prototype 2 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
666943|NCT02082158|E3|Reported Event|Prototype 1 Respirator Design|Subjects randomized to Prototype 1 will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
666944|NCT02082158|E2|Reported Event|Non-Local Respirator Model|Subjects randomized to the non-local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
666945|NCT02082158|E1|Reported Event|Local Respirator Model|Subjects randomized to the local respirator will be fit-tested prior to moving on to study intervention (study activities). Fit-testing failure will result in subject being randomized to another respirator and fit-testing procedures will be repeated.
666946|NCT02081859|B3|Baseline|Total|Total of all reporting groups
666947|NCT02081859|B2|Baseline|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
666948|NCT02081859|B1|Baseline|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
666949|NCT02081859|P2|Participant Flow|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
666950|NCT02081859|P1|Participant Flow|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
666951|NCT02081859|O2|Outcome|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
666952|NCT02081859|O1|Outcome|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
666953|NCT02081859|O2|Outcome|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
666954|NCT02081859|O1|Outcome|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
666955|NCT02081859|E2|Reported Event|Embryoscope Data|"Embryos will be scored based on both conventional rating and embryoscope data.~Embryoscope: The embryoscope is a microscope that allows for continuous time-lapse monitoring."
666956|NCT02081859|E1|Reported Event|Conventional Grading|"Embryos will be scored based on conventional criteria.~Conventional Criteria"
666957|NCT02081599|B3|Baseline|Total|Total of all reporting groups
666958|NCT02081599|B2|Baseline|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666959|NCT02081599|B1|Baseline|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666960|NCT02081599|P2|Participant Flow|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666961|NCT02081599|P1|Participant Flow|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666962|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666963|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666964|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666965|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
667059|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
666968|NCT02081599|O2|Outcome|Teneli (Teneligliptin) /Teneli + Insulin|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666969|NCT02081599|O1|Outcome|Placebo/Teneli (Teneligliptin) + Insulin|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) for an additional 36 weeks (open-label period) in combination with insulin.
666970|NCT02081599|E4|Reported Event|Teneli (Teneligliptin) /Teneli + Insulin(Data Through Week 52)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 52 were shown.
666971|NCT02081599|E3|Reported Event|Placebo/Teneli(Teneligliptin)+Insulin(Data From Week 16 to 52)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 16 to Week 52 were shown.
666972|NCT02081599|E2|Reported Event|Teneli (Teneligliptin)/Teneli + Insulin(Data Through Week 16)|Teneligliptin (20 mg once daily) for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
666973|NCT02081599|E1|Reported Event|Placebo/Teneli (Teneligliptin) + Insulin(Data Through Week 16)|Placebo for 16 weeks (double-blind period) followed by teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained) for an additional 36 weeks (open-label period) in combination with insulin. The adverse events which occured from Week 0 to Week 16 were shown.
666974|NCT02081586|B5|Baseline|Total|Total of all reporting groups
666975|NCT02081586|B4|Baseline|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666976|NCT02081586|B3|Baseline|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666977|NCT02081586|B2|Baseline|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666978|NCT02081586|B1|Baseline|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666979|NCT02081586|P4|Participant Flow|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666980|NCT02081586|P3|Participant Flow|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666981|NCT02081586|P2|Participant Flow|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666982|NCT02081586|P1|Participant Flow|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666983|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667011|NCT02081443|P2|Participant Flow|Ticagrelor 90mg|The proposed study has a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays were done following in vitro incubation with and without 500 nM cangrelor.
700674|NCT01851655|B3|Baseline|Total|Total of all reporting groups
666984|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666985|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666986|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666987|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666988|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666989|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666990|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666991|NCT02081586|O4|Outcome|Standard Diabetes Care at PCP|"Patients will remain in usual care and not receive study intervention. This will include usual diabetes care at PCP.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666992|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666993|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666994|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666995|NCT02081586|O5|Outcome|Participants Administered Phone CBT|This includes the 3 treatment arms who received Phone CBT, whether CBT treatment was 6, 8, or 12 weeks long.
666996|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667012|NCT02081443|P1|Participant Flow|Ticagrelor 180mg|The proposed study have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy were randomly assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays was done following in vitro incubation with and without 500 nM cangrelor.
668107|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
666997|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666998|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
666999|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667000|NCT02081586|O4|Outcome|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667001|NCT02081586|O3|Outcome|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667002|NCT02081586|O2|Outcome|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667003|NCT02081586|O1|Outcome|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667004|NCT02081586|E4|Reported Event|Treatment as Usual|"Patients will remain in usual care and not receive study intervention.~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667005|NCT02081586|E3|Reported Event|12 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 12 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667006|NCT02081586|E2|Reported Event|8 Weeks Phone CBT Plus Smartphone App|"Following baseline, patients will receive 8 weeks of phone CBT to address non-constructive beliefs, assumptions, attitudes or perceptions related to diabetes self-management. They will have a smartphone apps to practice CBT skills between sessions.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667007|NCT02081586|E1|Reported Event|6 Weeks Phone CBT Plus Smartphone App|"Following baseline, six 30-minute sessions of phone CBT to address any beliefs, assumptions, attitudes, or perceptions that are not constructive to diabetes self-management. CBT phone app will assist patients to practice skills related to improving self-management via more constructive ways of thinking.~CBT: Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.~Smartphone app: Smartphone app developed to assist patients practice CBT skills throughout the week~Standard Diabetes Care at PCP: Patients receive ADA standard of Care with physician at PCP office"
667008|NCT02081443|B3|Baseline|Total|Total of all reporting groups
667009|NCT02081443|B2|Baseline|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667010|NCT02081443|B1|Baseline|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667144|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667013|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667014|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667015|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667016|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667017|NCT02081443|O2|Outcome|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667018|NCT02081443|O1|Outcome|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667019|NCT02081443|E2|Reported Event|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667020|NCT02081443|E1|Reported Event|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
667021|NCT02081365|B3|Baseline|Total|Total of all reporting groups
667022|NCT02081365|B2|Baseline|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667023|NCT02081365|B1|Baseline|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667024|NCT02081365|P2|Participant Flow|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667025|NCT02081365|P1|Participant Flow|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667026|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667027|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667028|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667057|NCT02081079|P1|Participant Flow|Genotype 4|Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily for up to 12 weeks in participants with genotype 4 hepatitis C virus (HCV) infection
667145|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667029|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667030|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667031|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667032|NCT02081365|O2|Outcome|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667033|NCT02081365|O1|Outcome|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667034|NCT02081365|E2|Reported Event|Waiting List Control|"Before their dental appointments, participants completed self-report questionnaires and a telephone diagnostic interview. Waiting list control participants attended their scheduled dental appointment without receiving the computerized cognitive-behavioral therapy dental anxiety intervention but were offered the opportunity to receive the same intervention following all of their study assessments.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667035|NCT02081365|E1|Reported Event|Immediate Treatment|"Before the intervention, participants completed self-report questionnaires and a telephone diagnostic interview. Participants in the immediate treatment group were asked to come in 1.5 hours before a previously scheduled dental appointment to complete the computerized cognitive-behavioral therapy dental anxiety intervention (C-CBT).~The C-CBT consisted of a single-session, one-hour computerized intervention that assisted the participant in building skills for managing his or her dental anxiety.~One month after the dental appointment, participants were contacted by phone and asked to complete follow-up assessments."
667036|NCT02081183|B3|Baseline|Total|Total of all reporting groups
667037|NCT02081183|B2|Baseline|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667038|NCT02081183|B1|Baseline|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667039|NCT02081183|P2|Participant Flow|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667040|NCT02081183|P1|Participant Flow|Mycophenolate Mofetil (MMF), Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 to (-) 1 grams per square meter (g/m^2), intravenously (IV) once per month. Participants also received prednisone, 1 milligram per kilogram per day (mg/kg/day), tablets (or methylprednisolone IV), orally (PO); the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, twice daily (BID) for 2 weeks; 500 mg, PO, three times daily (TID) for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667058|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
667146|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667041|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667042|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667043|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667044|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667045|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667046|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667047|NCT02081183|O2|Outcome|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667048|NCT02081183|O1|Outcome|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667049|NCT02081183|E2|Reported Event|Cyclophosphamide, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV) PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received cyclophosphamide, 0.5-1 g/m^2, IV, once every 3 months. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667050|NCT02081183|E1|Reported Event|MMF, Prednisone|"Induction Phase (Months 1 through 6): Participants received cyclophosphamide, 0.5 -1 g/m^2, IV once per month. Participants also received prednisone, 1 mg/kg/day, tablets (or methylprednisolone IV), PO; the dose was reduced by 5 mg every 2 weeks up to 20 mg/day, then reduced by 2.5 mg every 2 weeks to a final maintenance dose of 10 mg/day.~Maintenance Phase (Months 7 through 12): Participants received MMF, 500 mg, tablets or capsules, PO, BID for 2 weeks; 500 mg, PO, TID for the next 2 weeks; 1 g, PO, BID for the remainder of the Maintenance Phase. Participants continued to receive maintenance prednisone (10 mg/day), as in the Induction Phase."
667051|NCT02081079|B5|Baseline|Total|Total of all reporting groups
667052|NCT02081079|B4|Baseline|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
667053|NCT02081079|B3|Baseline|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
667054|NCT02081079|B2|Baseline|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
667055|NCT02081079|B1|Baseline|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
667056|NCT02081079|P2|Participant Flow|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
667061|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
667062|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
667063|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
667064|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
667065|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
667066|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
667067|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
667068|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
667069|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
667070|NCT02081079|O2|Outcome|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
667071|NCT02081079|O1|Outcome|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
667072|NCT02081079|O4|Outcome|Genotype 5: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 5 HCV infection
667073|NCT02081079|O3|Outcome|Genotype 5: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 5 HCV infection
667074|NCT02081079|O2|Outcome|Genotype 4: Treatment-experienced|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-experienced participants with genotype 4 HCV infection
667075|NCT02081079|O1|Outcome|Genotype 4: Treatment-naive|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in treatment-naive participants with genotype 4 HCV infection
667076|NCT02081079|E2|Reported Event|Genotype 5|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 5 HCV infection
667077|NCT02081079|E1|Reported Event|Genotype 4|LDV/SOF (90/400 mg) FDC tablet administered orally once daily for up to 12 weeks in participants with genotype 4 HCV infection
667078|NCT02081014|B1|Baseline|Total Study Group|Includes all 12 treated subjects
667079|NCT02081014|P6|Participant Flow|G-Pen Mini™ Dose Order: 300, 150 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 75 ug SC injections at treatment visit 3.
667080|NCT02081014|P5|Participant Flow|G-Pen Mini™ Dose Order: 300, 75 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 300 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
667081|NCT02081014|P4|Participant Flow|G-Pen Mini™ Dose Order: 150, 300 & 75 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
667082|NCT02081014|P3|Participant Flow|G-Pen Mini™ Dose Order: 150, 75 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 150 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 75 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
667083|NCT02081014|P2|Participant Flow|G-Pen Mini™ Dose Order: 75, 300 & 150 Micrograms|G-Pen Mini™ (glucagon injection): two 75 ug SC injections at treatment visit 1, followed by a 2-21 day washout, then two 300 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 150 ug SC injections at treatment visit 3.
667084|NCT02081014|P1|Participant Flow|G-Pen Mini™ Dose Order: 75, 150 & 300 Micrograms|G-Pen Mini™ (glucagon injection): two 75 microgram (ug) subcutaneous (SC) injections at treatment visit 1, followed by a 2-21 day washout, then two 150 ug SC injections at treatment visit 2, followed by a 2-21 day washout, and finally two 300 ug SC injections at treatment visit 3.
667085|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667086|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667087|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667088|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
667089|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
667090|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
667147|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667091|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667092|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667093|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667094|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
667095|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
667096|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
667097|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667098|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667099|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667100|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
667101|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
667102|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
667103|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667104|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667105|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667106|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given fo subjects following an overnight fast
667107|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given fo subjects following an overnight fast
667108|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given fo subjects following an overnight fast
667109|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667110|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667111|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667112|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
667113|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
667114|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
667115|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667116|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667117|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects in a state of mild hypoglycemia
667118|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), a single 300 microgram subcutaneous injection given given to subjects after an overnight fast
667119|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), a single 150 microgram subcutaneous injection given given to subjects after an overnight fast
667120|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), a single 75 microgram subcutaneous injection given to subjects after an overnight fast
667121|NCT02081014|O3|Outcome|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
667122|NCT02081014|O2|Outcome|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
667123|NCT02081014|O1|Outcome|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
667124|NCT02081014|E3|Reported Event|G-Pen Mini™ (Glucagon Injection) 300 ug|G-Pen Mini™ (glucagon injection), two 300 microgram subcutaneous injections given approximately 4-5 hours apart
667125|NCT02081014|E2|Reported Event|G-Pen Mini™ (Glucagon Injection) 150 ug|G-Pen Mini™ (glucagon injection), two 150 microgram subcutaneous injections given approximately 4-5 hours apart
667126|NCT02081014|E1|Reported Event|G-Pen Mini™ (Glucagon Injection) 75 ug|G-Pen Mini™ (glucagon injection), two 75 microgram subcutaneous injections given approximately 4-5 hours apart
667127|NCT02081001|B3|Baseline|Total|Total of all reporting groups
667128|NCT02081001|B2|Baseline|GlucaGen First, Followed by Xeris G-Pump|Subjects who received GlucaGen at the first treatment visit and G-Pump (glucagon infusion) at the second treatment visit.
667129|NCT02081001|B1|Baseline|Xeris G-Pump Glucagon First, Followed by GlucaGen|Subjects who received G-Pump (glucagon infusion) at the first treatment visit and GlucaGen at the second treatment visit.
667130|NCT02081001|P12|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
667131|NCT02081001|P11|Participant Flow|Dose Order: 2, 1.2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 1.2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
667132|NCT02081001|P10|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
667133|NCT02081001|P9|Participant Flow|Dose Order: 2, 0.3 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 2.0, 0.3 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
667134|NCT02081001|P8|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
667135|NCT02081001|P7|Participant Flow|Dose Order: 1.2, 2 & 0.3 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 2 and 0.3 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
667136|NCT02081001|P6|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
667137|NCT02081001|P5|Participant Flow|Dose Order: 1.2, 0.3 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 1.2, 0.3 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
667138|NCT02081001|P4|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
667139|NCT02081001|P3|Participant Flow|Dose Order: 0.3, 2 & 1.2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 2.0 and 1.2 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
667140|NCT02081001|P2|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: GlucaGen/G-Pump|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received GlucaGen at the first treatment visit and G-Pump glucagon at the second treatment visit.
667141|NCT02081001|P1|Participant Flow|Dose Order: 0.3, 1.2 & 2 μg/kg; Drug Order: G-Pump/GlucaGen|Subjects received three doses of glucagon 2.5 hours apart at each of two treatment visits separated by a wash-out period of 3-28 days. Bolus doses were administered subcutaneously via an OmniPod infusion pump placed on the anterior abdomen. Subjects in this group received doses in the order of 0.3, 1.2 and 2.0 μg/kg of body weight at each visit, and received G-Pump glucagon at the first treatment visit and GlucaGen at the second treatment visit.
667142|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667143|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667148|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667149|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667151|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667152|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667153|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667154|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667155|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667156|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667157|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667158|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667159|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667160|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667161|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667162|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667163|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667164|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667165|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667166|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667167|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667168|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667169|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667170|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667171|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667172|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667173|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667174|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667175|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667176|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667177|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667178|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667179|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667180|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667181|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667182|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667183|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667184|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667185|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667186|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667187|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667188|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667189|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667190|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667191|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667192|NCT02081001|O4|Outcome|0.3 μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667193|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667194|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667195|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667196|NCT02081001|O6|Outcome|2.0 μg/kg GlucaGen|2.0 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667197|NCT02081001|O5|Outcome|1.2 μg/kg GlucaGen|1.2 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667198|NCT02081001|O4|Outcome|0.3μg/kg GlucaGen|0.3 μg/kg dose of GlucaGen delivered via OmniPod sc infusion pump
667199|NCT02081001|O3|Outcome|2.0 μg/kg G-Pump|2.0 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667200|NCT02081001|O2|Outcome|1.2 μg/kg G-Pump|1.2 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667201|NCT02081001|O1|Outcome|0.3 μg/kg G-Pump|0.3 μg/kg dose of G-Pump (glucagon infusion) delivered via OmniPod sc infusion pump
667438|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667202|NCT02081001|E2|Reported Event|Novo Nordisk GlucaGen®|Novo Nordisk GlucaGen®; single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg, and 2.0 μg/kg delivered by infusion pump
667203|NCT02081001|E1|Reported Event|G-Pump™ (Glucagon Infusion)|G-Pump™ (glucagon infusion); single subcutaneous doses of 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg delivered via infusion pump
667204|NCT02080780|B1|Baseline|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
667205|NCT02080780|P1|Participant Flow|2% Diltiazem & Clarithromycin XL|"3 parts:~- Diltiazem Single Dose~- Clarithromycin XL (Days 4-9)~- Diltiazem Single Dose after Clarithromycin~Clarithromycin XL: Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg~2% Diltiazem: 2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)"
667206|NCT02080780|O2|Outcome|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
667207|NCT02080780|O1|Outcome|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
667208|NCT02080780|E3|Reported Event|Diltiazem Single Dose After Clarithromycin|2% Diltiazem Hydrochloride Cream applied on Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg) following Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
667209|NCT02080780|E2|Reported Event|Clarithromycin XL (Days 4-9)|On Days 4 through 9, subjects received once daily doses of clarithromycin XL (2 tablets, 500 mg/tablet, total dose = 1000 mg/day; 6000 mg total in 6 days) with 24 hours between doses.
667210|NCT02080780|E1|Reported Event|Diltiazem Single Dose|On the morning of Day 1, subjects received a single dose of DTZ 2% cream (~2.5 cm [1 inch] strip of cream containing approximately 8.5 mg DTZ) applied perianally. area (~2.5 cm [1 inch]; ~8.5 mg)
667211|NCT02080546|B3|Baseline|Total|Total of all reporting groups
667212|NCT02080546|B2|Baseline|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667213|NCT02080546|B1|Baseline|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667214|NCT02080546|P2|Participant Flow|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667215|NCT02080546|P1|Participant Flow|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667216|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667217|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667218|NCT02080546|O2|Outcome|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667219|NCT02080546|O1|Outcome|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667220|NCT02080546|E2|Reported Event|V-mode|"V-mode: Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667221|NCT02080546|E1|Reported Event|Cut/Coag|"Cut-Coag: Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode.~Valleylab G3000 Electrosurgical Device: Use of surgical device Valleylab G3000 Electrosurgical Device"
667222|NCT02080507|B3|Baseline|Total|Total of all reporting groups
667334|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667223|NCT02080507|B2|Baseline|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667224|NCT02080507|B1|Baseline|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667225|NCT02080507|P2|Participant Flow|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667226|NCT02080507|P1|Participant Flow|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667227|NCT02080507|O2|Outcome|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667228|NCT02080507|O1|Outcome|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667229|NCT02080507|O2|Outcome|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667230|NCT02080507|O1|Outcome|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667231|NCT02080507|E2|Reported Event|Inactive Neuronetics rTMS Stimulator|Participants in this group were randomized to receive sham repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667232|NCT02080507|E1|Reported Event|Active Neuronetics rTMS Stimulator|Participants in this group were randomized to receive active repetitive transcranial magnetic stimulation (rTMS) five times a week at 10 pulses/sec, 120% of motor threshold, and 3000 pulses/session for 4 weeks.
667233|NCT02080481|B3|Baseline|Total|Total of all reporting groups
667234|NCT02080481|B2|Baseline|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
667235|NCT02080481|B1|Baseline|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
667236|NCT02080481|P2|Participant Flow|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
667237|NCT02080481|P1|Participant Flow|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
667238|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
667239|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
667240|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
667241|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
667242|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
667243|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
667244|NCT02080481|O2|Outcome|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
667245|NCT02080481|O1|Outcome|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
667246|NCT02080481|E2|Reported Event|Conventional Block Needle|"ultrasound guidance with a conventional block needle~Conventional block needle: conventional block needle used for insertion of femoral nerve catheters."
667247|NCT02080481|E1|Reported Event|Infiniti Plus Needle Guidance System|"ultrasound guidance with the InfinitiPlus (TM) needle guidance system~Infiniti Plus needle guidance system: The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks."
667248|NCT02080312|B1|Baseline|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
667249|NCT02080312|P1|Participant Flow|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
667300|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
668116|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
667250|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
667251|NCT02080312|O1|Outcome|Intratympanic Injection|Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.
667252|NCT02080312|O1|Outcome|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
667253|NCT02080312|E1|Reported Event|Intratympanic Injection|"Magnevist (gadopentetate dimeglumine, Bayer Health Care) will be diluted eightfold with sterile saline (1:7 v/v) in a 1 ml syringe and injected intra-tympanically with a 23-25g needle up to 0.4 ml or less if contrast reflux is noted under direct visualization. Anesthesia with topical phenol is available for this procedure.~Magnevist (gadopentetate dimeglumine)"
667254|NCT02080091|B1|Baseline|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
667255|NCT02080091|P1|Participant Flow|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
667256|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
667257|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
667258|NCT02080091|O1|Outcome|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
667259|NCT02080091|E1|Reported Event|Chronic DME|Patients with vision impairment associated with chronic diabetic macular edema (DME)
667260|NCT02079844|B4|Baseline|Total|Total of all reporting groups
667261|NCT02079844|B3|Baseline|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667262|NCT02079844|B2|Baseline|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667263|NCT02079844|B1|Baseline|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667264|NCT02079844|P3|Participant Flow|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667265|NCT02079844|P2|Participant Flow|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667266|NCT02079844|P1|Participant Flow|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667267|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667268|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667269|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667270|NCT02079844|O3|Outcome|Roflumilast 250 μg + Placebo + Roflumilast 100 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667299|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667335|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667271|NCT02079844|O2|Outcome|Roflumilast 100 μg + Roflumilast 250 μg + Placebo|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667272|NCT02079844|O1|Outcome|Placebo + Roflumilast 100 μg + Roflumilast 250 μg|Roflumilast placebo-matching tablets, orally, once, daily, Days 1 through 8, Period 1, followed by a 14 day washout period, followed by roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8, Period 2, followed by a 14 day washout period, followed by roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8, Period 3. All participants will take a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667273|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667274|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667275|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667276|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667277|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667278|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667279|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667280|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667281|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667282|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667283|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667284|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667285|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667286|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667287|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667288|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667289|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667290|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667291|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667292|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667293|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667294|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667295|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667296|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667297|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667298|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667301|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667302|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667303|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667304|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667305|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667306|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667307|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667308|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667309|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667310|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667311|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667312|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667313|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667314|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667315|NCT02079844|O3|Outcome|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667316|NCT02079844|O2|Outcome|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667317|NCT02079844|O1|Outcome|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667318|NCT02079844|E3|Reported Event|Roflumilast 250 μg|Roflumilast 250 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667319|NCT02079844|E2|Reported Event|Roflumilast 100 μg|Roflumilast 100 μg tablets, orally, once, daily, Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667320|NCT02079844|E1|Reported Event|Placebo|Roflumilast placebo-matching tablets orally, once, daily on Days 1 through 8. All participants took a stable dose of second generation antipsychotics throughout the duration of the treatment period.
667321|NCT02079649|B5|Baseline|Total|Total of all reporting groups
667322|NCT02079649|B4|Baseline|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667323|NCT02079649|B3|Baseline|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667324|NCT02079649|B2|Baseline|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667325|NCT02079649|B1|Baseline|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667326|NCT02079649|P4|Participant Flow|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667327|NCT02079649|P3|Participant Flow|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667328|NCT02079649|P2|Participant Flow|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667329|NCT02079649|P1|Participant Flow|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667330|NCT02079649|O4|Outcome|Vehicle|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667331|NCT02079649|O3|Outcome|Maxidex|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667332|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667333|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667336|NCT02079649|O2|Outcome|AL-53817|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
668117|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
667337|NCT02079649|O1|Outcome|AL-78843|One drop in each eye twice daily for 6-8 days followed by 1 drop in each eye once on the last day of dosing (Day 7, 8, or 9)
667338|NCT02079649|E5|Reported Event|Vehicle|Includes all subjects who were randomized to and treated with investigational product
667339|NCT02079649|E4|Reported Event|Maxidex|Includes all subjects who were randomized to and treated with investigational product
667340|NCT02079649|E3|Reported Event|AL-53817|Includes all subjects who were randomized to and treated with investigational product
667341|NCT02079649|E2|Reported Event|AL-78843|Includes all subjects who were randomized to and treated with investigational product
667342|NCT02079649|E1|Reported Event|Pre-Treatment|Includes all subjects who consented to participate in the study
667343|NCT02079532|B1|Baseline|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667344|NCT02079532|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab, 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667345|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667346|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667347|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667348|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667349|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667350|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667351|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667352|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667353|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667354|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667355|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667356|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667357|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667358|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667435|NCT02076919|P1|Participant Flow|LHA510, Part 1|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye as a single dose during Part 1
667437|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667359|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667360|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667361|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667362|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667363|NCT02079532|O1|Outcome|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667364|NCT02079532|E1|Reported Event|Rituximab + MTX|Participants received rituximab, 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants should have also been receiving MTX as mandatory background therapy. MTX was to have been started at least 3 months prior to the first infusion and must have been given at stable doses for at least 4 weeks prior to the first infusion.
667365|NCT02079519|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
667366|NCT02079519|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
667367|NCT02079519|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
667368|NCT02079519|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks for 6 months until disease progression or termination of the study. Participants showing a continuous benefit of therapy could receive treatment for a maximum of 12 months.
667369|NCT02079311|B3|Baseline|Total|Total of all reporting groups
667370|NCT02079311|B2|Baseline|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
667371|NCT02079311|B1|Baseline|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
667372|NCT02079311|P2|Participant Flow|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
667373|NCT02079311|P1|Participant Flow|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
667374|NCT02079311|O2|Outcome|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
667375|NCT02079311|O1|Outcome|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
667376|NCT02079311|E2|Reported Event|Forced Air Warming Device|"Active warming with forced air warming (FAW) during the intraoperative phase.~Forced air warming device: Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection."
667377|NCT02079311|E1|Reported Event|Active Self-warming Blanket|"Active warming with BARRIER® EasyWarm active self-warming blanket during the perioperative phase~Active self warming blanket: BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron."
667378|NCT02078492|B4|Baseline|Total|Total of all reporting groups
667379|NCT02078492|B3|Baseline|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
667380|NCT02078492|B2|Baseline|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
667381|NCT02078492|B1|Baseline|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
667382|NCT02078492|P3|Participant Flow|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
667383|NCT02078492|P2|Participant Flow|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
667436|NCT02076919|O7|Outcome|Vehicle, Part 2|One drop instilled in the study eye once, twice, or three times daily for 7 days
667384|NCT02078492|P1|Participant Flow|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
667385|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
667386|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
667387|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
667388|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
667389|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
667390|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
667391|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
667392|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
667393|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
667394|NCT02078492|O3|Outcome|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
667395|NCT02078492|O2|Outcome|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
667396|NCT02078492|O1|Outcome|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
667397|NCT02078492|E3|Reported Event|Group 3 - 30mg|"Subject will receive 30mg of Ketorolac as a part of standard care.~30 mg of Ketorolac: Patients will receive 30mg of Ketorolac for pain control."
667398|NCT02078492|E2|Reported Event|Group 2 - 15mg|"Subjects will be administered 15mg of Ketorolac.~15 mg of Ketorolac: Patients will receive 15mg of Ketorolac for pain control."
667399|NCT02078492|E1|Reported Event|Group 1 - 10 mg of Ketorolac|"Subjects will be administered 10 mg of Ketorolac for pain relief.~10 mg of Ketorolac: Patients will receive 10 mg of Ketorolac for pain control."
667400|NCT02077374|B3|Baseline|Total|Total of all reporting groups
667401|NCT02077374|B2|Baseline|Placebo|"Placebo~Matching Placebo BID for 28 days"
667402|NCT02077374|B1|Baseline|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667403|NCT02077374|P2|Participant Flow|Placebo|"Placebo~Matching Placebo BID for 28 days"
667404|NCT02077374|P1|Participant Flow|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667405|NCT02077374|O2|Outcome|Placebo|"Placebo~Placebo: Placebo BID for 28 Days"
667406|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667407|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
667408|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667409|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
667410|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667411|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
667412|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667413|NCT02077374|O2|Outcome|Placebo|"Placebo~Placebo: Placebo Twice daily for 28 Days"
667414|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg Twice daily for 28 days"
667415|NCT02077374|O2|Outcome|Placebo|"Placebo~Matching Placebo BID for 28 days"
667416|NCT02077374|O1|Outcome|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667417|NCT02077374|E2|Reported Event|Placebo|"Placebo~Matching Placebo BID for 28 days"
667418|NCT02077374|E1|Reported Event|IDN-6556|"IDN-6556 capsules, 25 mg~IDN-6556: 25 mg BID for 28 days"
667419|NCT02076919|B13|Baseline|Total|Total of all reporting groups
667420|NCT02076919|B12|Baseline|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
667421|NCT02076919|B11|Baseline|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667422|NCT02076919|B10|Baseline|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667423|NCT02076919|B9|Baseline|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667424|NCT02076919|B8|Baseline|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667425|NCT02076919|B7|Baseline|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667426|NCT02076919|B6|Baseline|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667427|NCT02076919|B5|Baseline|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
667428|NCT02076919|B4|Baseline|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
667429|NCT02076919|B3|Baseline|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
667430|NCT02076919|B2|Baseline|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
667431|NCT02076919|B1|Baseline|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
667432|NCT02076919|P4|Participant Flow|Vehicle, Part 2|Inactive ingredients, 1 drop instilled in the study eye once, twice, or 3 times daily for 7 days during Part 2
667433|NCT02076919|P3|Participant Flow|LHA510, Part 2|Ophthalmic suspension in 1 of 4 concentrations, 1 drop instilled in the study eye once, twice, or three times daily for 7 days during Part 2
667434|NCT02076919|P2|Participant Flow|Vehicle, Part 1|Inactive ingredients, 1 drop instilled in the study eye as a single dose during Part 1
667439|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667440|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667441|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667442|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667443|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
667444|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667445|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667446|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667447|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667448|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667449|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667450|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
667451|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667452|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667453|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667454|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667455|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667456|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667457|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
667458|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
667459|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
667460|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
667461|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
667462|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
667463|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
667464|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
667465|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
667466|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
667467|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
667468|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667469|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667470|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667471|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667472|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667473|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667474|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
667475|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
667476|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
667477|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
667478|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
667479|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
667480|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
667481|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
667482|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
667483|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
667484|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667485|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667486|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667487|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667488|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667489|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667490|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667491|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667492|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667493|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667494|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667495|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667496|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667497|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667498|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667499|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667500|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667501|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667502|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667503|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667504|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667505|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667506|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667507|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667508|NCT02076919|O7|Outcome|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
667509|NCT02076919|O6|Outcome|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667510|NCT02076919|O5|Outcome|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667511|NCT02076919|O4|Outcome|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667512|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667513|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667514|NCT02076919|O1|Outcome|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667515|NCT02076919|O5|Outcome|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
667516|NCT02076919|O4|Outcome|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
667517|NCT02076919|O3|Outcome|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
667518|NCT02076919|O2|Outcome|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
667519|NCT02076919|O1|Outcome|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
667520|NCT02076919|E12|Reported Event|Vehicle, Part 2|1 drop instilled in the study eye once, twice, or three times daily for 7 days
667521|NCT02076919|E11|Reported Event|LHA510 Highest TID, Part 2|1 drop instilled in the study eye three times daily for 7 days
667522|NCT02076919|E10|Reported Event|LHA510 Highest BID, Part 2|1 drop instilled in the study eye twice daily for 7 days
667523|NCT02076919|E9|Reported Event|LHA510 Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667524|NCT02076919|E8|Reported Event|LHA510 Next Highest, Part 2|1 drop instilled in the study eye once daily for 7 days
667525|NCT02076919|E7|Reported Event|LHA510 Next Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667526|NCT02076919|E6|Reported Event|LHA510 Lowest, Part 2|1 drop instilled in the study eye once daily for 7 days
667527|NCT02076919|E5|Reported Event|Vehicle, Part 1|1 drop instilled in the study eye as a single dose
667528|NCT02076919|E4|Reported Event|LHA510 Highest, Part 1|1 drop instilled in the study eye as a single dose
667529|NCT02076919|E3|Reported Event|LHA510 Next Highest, Part 1|1 drop instilled in the study eye as a single dose
667530|NCT02076919|E2|Reported Event|LHA510 Next Lowest, Part 1|1 drop instilled in the study eye as a single dose
667531|NCT02076919|E1|Reported Event|LHA510 Lowest, Part 1|1 drop instilled in the study eye as a single dose
667532|NCT02076009|B3|Baseline|Total|Total of all reporting groups
667533|NCT02076009|B2|Baseline|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667534|NCT02076009|B1|Baseline|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667535|NCT02076009|P2|Participant Flow|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667536|NCT02076009|P1|Participant Flow|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667537|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667582|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667538|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667539|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667540|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667541|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667542|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667543|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667544|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667545|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667546|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667547|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667548|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667549|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667550|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667551|NCT02076009|O2|Outcome|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667552|NCT02076009|O1|Outcome|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667581|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
668108|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
667553|NCT02076009|E2|Reported Event|Daratumumab, Lenalidomide, Dexamethasone (DRd)|Participants received daratumumab 16 milligram per kilogram (mg/kg) as an intravenous (IV) infusion once a week during treatment cycles 1 and 2 (for 8 weeks); every 2 weeks during treatment cycles 3 to 6 (for 16 weeks); once only (on Day 1) during treatment cycles 7 onwards (for every 4 weeks). Lenalidomide was administered at a dose of 25 mg orally on Days 1 through 21 of each treatment cycle and dexamethasone was administered as a total dose of 40 mg weekly (or 20 mg weekly for participants > 75 years old or with a body mass index < 8.5).
667554|NCT02076009|E1|Reported Event|Lenalidomide, Low-dose Dexamethasone (Rd)|Participants received lenalidomide at a dose of 25 milligram (mg) orally on Days 1 through 21 of each treatment cycle and dexamethasone as a total dose of 40 mg weekly (or 20 mg weekly for participants greater than (>) 75 years old or with a body mass index less than [<] 8.5).
667555|NCT02075632|B3|Baseline|Total|Total of all reporting groups
667556|NCT02075632|B2|Baseline|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used
667557|NCT02075632|B1|Baseline|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
667558|NCT02075632|P2|Participant Flow|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
667559|NCT02075632|P1|Participant Flow|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
667560|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
667561|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
667562|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
667563|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
667564|NCT02075632|O2|Outcome|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
667565|NCT02075632|O1|Outcome|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
667566|NCT02075632|E2|Reported Event|Occasional Itch|Participants who suffered from occasional itchy skin experiences (such as poison ivy, oak, sumac, insect bites, or skin irritations due to jewelry, cosmetics, detergents, or soaps) where an anti-itch medication would be used.
667567|NCT02075632|E1|Reported Event|Chronic Condition|Participants who suffered from eczema or psoriasis where an anti-itch medication would be used.
667568|NCT02075515|B4|Baseline|Total|Total of all reporting groups
667569|NCT02075515|B3|Baseline|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667570|NCT02075515|B2|Baseline|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667571|NCT02075515|B1|Baseline|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667572|NCT02075515|P3|Participant Flow|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667573|NCT02075515|P2|Participant Flow|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667574|NCT02075515|P1|Participant Flow|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
667575|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667576|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667577|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667578|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667579|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667580|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
667664|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
668109|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
667583|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667584|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667585|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667586|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667587|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667588|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667589|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
667590|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667591|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667592|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667593|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667594|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667595|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
667596|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667597|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667598|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
667599|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667600|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667601|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667602|NCT02075515|O3|Outcome|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667603|NCT02075515|O2|Outcome|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667604|NCT02075515|O1|Outcome|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667605|NCT02075515|E3|Reported Event|GSK1437173A Lot C Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot C, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667606|NCT02075515|E2|Reported Event|GSK1437173A Lot B Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot B, administered intramuscularly in deltoid region of non-dominant arm, at 0 and 2 months.
667607|NCT02075515|E1|Reported Event|GSK1437173A Lot A Group|Male and female subjects, aged ≥ 50 years at the time of study vaccination, received a dose of the GSK1437173A vaccine from Lot A, administered intramuscularly in the deltoid region of non-dominant arm, at 0 and 2 months.
667608|NCT02075411|B5|Baseline|Total|Total of all reporting groups
667665|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
668118|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
667609|NCT02075411|B4|Baseline|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667610|NCT02075411|B3|Baseline|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667611|NCT02075411|B2|Baseline|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
667612|NCT02075411|B1|Baseline|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
667613|NCT02075411|P4|Participant Flow|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667614|NCT02075411|P3|Participant Flow|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667615|NCT02075411|P2|Participant Flow|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
667616|NCT02075411|P1|Participant Flow|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
667617|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667618|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667619|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
667620|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
667621|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667622|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667623|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
667624|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
667625|NCT02075411|O4|Outcome|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667626|NCT02075411|O3|Outcome|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667627|NCT02075411|O2|Outcome|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
667628|NCT02075411|O1|Outcome|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
667629|NCT02075411|E4|Reported Event|Females Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667630|NCT02075411|E3|Reported Event|Males Continuous Peripheral Neural Infusion|"The placement of a femoral continuous peripheral nerve infusion catheter (CPNI) and 0.25% bupivacaine (0.5 ml/kg, max 20 ml) will be injected under ultrasound guidance.~continuous perineural infusion catheter: Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair."
667631|NCT02075411|E2|Reported Event|Females Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Females Single shot peripheral nerve block"
667632|NCT02075411|E1|Reported Event|Males Single Shot Peripheral Nerve Block|"a single injection peripheral nerve block (FS/SS) of the femoral and sciatic nerves, Femoral Block - 0.25% bupivacaine (0.5 ml/kg, max 40 ml). The sciatic block will be performed using 0.125% bupivacaine (0.5 ml/kg, max 20 ml).~bupivacaine: Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.~Males Single shot peripheral nerve block"
667633|NCT02075125|B3|Baseline|Total|Total of all reporting groups
667634|NCT02075125|B2|Baseline|Ticagrelor|Patients administer Ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667635|NCT02075125|B1|Baseline|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667636|NCT02075125|P2|Participant Flow|Ticagrelor|Patient administer Ticagrelor 180 mg as loading dose followed by 90 mg twice a day as maintenance dose.
667637|NCT02075125|P1|Participant Flow|Prasugrel|Patient administer Prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667638|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667639|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667640|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667641|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667642|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667643|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667644|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667645|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667646|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667647|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667648|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667649|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667650|NCT02075125|O2|Outcome|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667651|NCT02075125|O1|Outcome|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667652|NCT02075125|E2|Reported Event|Ticagrelor|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
667653|NCT02075125|E1|Reported Event|Prasugrel|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
667654|NCT02075073|B4|Baseline|Total|Total of all reporting groups
667655|NCT02075073|B3|Baseline|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
667656|NCT02075073|B2|Baseline|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
667657|NCT02075073|B1|Baseline|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
667658|NCT02075073|P3|Participant Flow|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
667659|NCT02075073|P2|Participant Flow|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
667660|NCT02075073|P1|Participant Flow|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
667661|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
667662|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
667663|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
668061|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
667666|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
667667|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
667668|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
667669|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
667670|NCT02075073|O3|Outcome|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
667671|NCT02075073|O2|Outcome|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
667672|NCT02075073|O1|Outcome|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
667673|NCT02075073|E3|Reported Event|US Sourced Herceptin®|"US sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~US sourced Herceptin®"
667674|NCT02075073|E2|Reported Event|EU Sourced Herceptin®|"EU sourced Herceptin®, single dose of 6 mg/kg via intravenous infusion (reference drug)~EU sourced Herceptin®"
667675|NCT02075073|E1|Reported Event|SB3 (Proposed Trastuzumab Biosimilar)|"SB3, single dose of 6 mg/kg via intravenous infusion (study drug)~SB3"
667676|NCT02075008|B1|Baseline|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
667677|NCT02075008|P1|Participant Flow|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
667678|NCT02075008|O1|Outcome|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
667679|NCT02075008|E1|Reported Event|QGE031 Every 4 Weeks (q4w)|QGE031 240 mg subcutaneously q4w
667680|NCT02074995|B1|Baseline|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667681|NCT02074995|P3|Participant Flow|BVS857 Group 1B/1C, 2, 3, 4 Double Blind|
667682|NCT02074995|P2|Participant Flow|Placebo Group 1B/1C, 2, 3, 4|
667683|NCT02074995|P1|Participant Flow|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667684|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667685|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667686|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667687|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667688|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667689|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667690|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667691|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667692|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667693|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667694|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667695|NCT02074995|O1|Outcome|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667696|NCT02074995|E1|Reported Event|BVS857 Grp 1A Open Label|0.03 mg/kg of BVS857 intravenously in open label manner followed by subsequent subcutaneous doses weekly at day 15,22 and 29.
667697|NCT02074709|B3|Baseline|Total|Total of all reporting groups
667698|NCT02074709|B2|Baseline|Wound Infiltration|Wound infiltration with liposomal bupivacaine
667699|NCT02074709|B1|Baseline|TAP Block|TAP block with plain bupivacaine
667700|NCT02074709|P2|Participant Flow|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
667701|NCT02074709|P1|Participant Flow|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
667702|NCT02074709|O2|Outcome|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV"
667703|NCT02074709|O1|Outcome|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV ."
667736|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
668063|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
667704|NCT02074709|E2|Reported Event|Wound Infiltration|"Wound infiltration with liposomal bupivacaine~Liposomal bupivacaine: Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
667705|NCT02074709|E1|Reported Event|TAP Block|"TAP block with plain bupivacaine~Plain bupivacaine: Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
667706|NCT02074553|B3|Baseline|Total|Total of all reporting groups
667707|NCT02074553|B2|Baseline|Part 2 (Fed): Study Population|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 2 of the study.
667708|NCT02074553|B1|Baseline|Part 1 (Fasted): Study Population|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A, B, C, and D according to any of the four treatment sequences in Part 1 of the study.
667709|NCT02074553|P8|Participant Flow|Part 2 (Fed): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667710|NCT02074553|P7|Participant Flow|Part 2 (Fed): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667711|NCT02074553|P6|Participant Flow|Part 2 (Fed): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667712|NCT02074553|P5|Participant Flow|Part 2 (Fed): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours ate a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after start of the meal received 600 mg of alectinib as a capsule formulation orally in Part 2 of the study according to following treatment sequences. Treatment A (formulation containing 50% SLS) on Day 1 of the first intervention period; then Treatment B (formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667713|NCT02074553|P4|Participant Flow|Part 1 (Fasted): Treatment D Then C Then B Then A|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment D (formulation containing 3% SLS) on Day 1 of the first intervention period; then Treatment C (formulation containing 12.5% SLS) on Day 1 of second intervention period (Day 11); then Treatment B (formulation containing 25% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment A (formulation containing 50% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667714|NCT02074553|P3|Participant Flow|Part 1 (Fasted): Treatment C Then A Then D Then B|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment C (formulation containing 12.5% SLS) on Day 1 of the first intervention period; then Treatment A (formulation containing 50% SLS) on Day 1 of second intervention period (Day 11); then Treatment D (formulation containing 3% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment B (formulation containing 25% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667715|NCT02074553|P2|Participant Flow|Part 1 (Fasted): Treatment B Then D Then A Then C|Participants following an overnight fast of at least 10 hours received 600 mg of alectinib as a capsule formulation orally in Part 1 of the study according to following treatment sequences. Treatment B (formulation containing 25% SLS) on Day 1 of the first intervention period; then Treatment D (formulation containing 3% SLS) on Day 1 of second intervention period (Day 11); then Treatment A (formulation containing 50% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment C (formulation containing 12.5% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667737|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
668062|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
667716|NCT02074553|P1|Participant Flow|Part 1 (Fasted): Treatment A Then B Then C Then D|Participants following an overnight fast of at least 10 hours received 600 milligram (mg) of alectinib (RO5424802) as a capsule formulation (four 150 mg capsules) orally in Part 1 of the study according to following treatment sequences. Treatment A (Reference Treatment: formulation containing 50 percent [%]sodium lauryl sulfate [SLS]) on Day 1 of the first intervention period; then Treatment B (Test Treatment: formulation containing 25% SLS) on Day 1 of second intervention period (Day 11); then Treatment C (Test Treatment: formulation containing 12.5% SLS) on Day 1 of third intervention period (Day 21); followed by Treatment D (Test Treatment: formulation containing 3% SLS) on Day 1 of fourth intervention period (Day 31). A washout period of at least 10 days was maintained between each intervention period.
667717|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667718|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667719|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667720|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667721|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667722|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667723|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667724|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667725|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667726|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667727|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667728|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667729|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667730|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667731|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667732|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667733|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667734|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667735|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667738|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667739|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667740|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667741|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667742|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667743|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667744|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667745|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667746|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667747|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667748|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667749|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667750|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667751|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667752|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667753|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667754|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667755|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667756|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667757|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667758|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667759|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667760|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667761|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667762|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667763|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667764|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667765|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667766|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667767|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667768|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667769|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667770|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667771|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667772|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667773|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667774|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667775|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667776|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667777|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667778|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667779|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667780|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667781|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667782|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667783|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667875|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
701279|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
667784|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667785|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667786|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667787|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667788|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667789|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667790|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667791|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667792|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667793|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667794|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667795|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667796|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667797|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667798|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667799|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667800|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667801|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667802|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667803|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667804|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667805|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667806|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
701280|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
667807|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667808|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667809|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667810|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667811|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667812|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667813|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667814|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667815|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667816|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667817|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667818|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667819|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667820|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667821|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667822|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667823|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667824|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667825|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667826|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667827|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667828|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667829|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
701281|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
667830|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667831|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667832|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667833|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667834|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667835|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667836|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667837|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667838|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667839|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667840|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667841|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667842|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667843|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667844|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667845|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667846|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667847|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667848|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667849|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667850|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667851|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667852|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
701282|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
667853|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667854|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667855|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667856|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667857|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667858|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667859|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667860|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667861|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667862|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667863|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667864|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667865|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667866|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667867|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667868|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667869|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667870|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667871|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667872|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667873|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667874|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667902|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
667876|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667877|NCT02074553|O8|Outcome|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667878|NCT02074553|O7|Outcome|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667879|NCT02074553|O6|Outcome|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667880|NCT02074553|O5|Outcome|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667881|NCT02074553|O4|Outcome|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667882|NCT02074553|O3|Outcome|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667883|NCT02074553|O2|Outcome|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667884|NCT02074553|O1|Outcome|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667885|NCT02074553|E8|Reported Event|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
667886|NCT02074553|E7|Reported Event|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
667887|NCT02074553|E6|Reported Event|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
667888|NCT02074553|E5|Reported Event|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours ate the high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
667889|NCT02074553|E4|Reported Event|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment D (formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
667890|NCT02074553|E3|Reported Event|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment C (formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
667891|NCT02074553|E2|Reported Event|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment B (formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
667892|NCT02074553|E1|Reported Event|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours received alectinib 600 mg capsules orally as Treatment A (formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
667893|NCT02074514|B5|Baseline|Total|Total of all reporting groups
667894|NCT02074514|B4|Baseline|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
667895|NCT02074514|B3|Baseline|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
667896|NCT02074514|B2|Baseline|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
667897|NCT02074514|B1|Baseline|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
667898|NCT02074514|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks.
667899|NCT02074514|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 16 weeks.
667900|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
667901|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
701283|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
667903|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
667904|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
667905|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
667906|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
667907|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
667908|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
667909|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
667910|NCT02074514|O4|Outcome|SOF + RBV 24 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 3 HCV infection
667911|NCT02074514|O3|Outcome|SOF + RBV 16 Weeks GT3|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype 3 HCV infection
667912|NCT02074514|O2|Outcome|SOF + RBV 24 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks in participants with genotype 1 HCV infection
667913|NCT02074514|O1|Outcome|SOF + RBV 16 Weeks GT1|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks in participants with genotype (GT) 1 HCV infection
667914|NCT02074514|E2|Reported Event|SOF + RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
667915|NCT02074514|E1|Reported Event|SOF + RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 16 weeks
667916|NCT02074384|B4|Baseline|Total|Total of all reporting groups
667917|NCT02074384|B3|Baseline|Clinicians|Clinicians completing the study visits.
667918|NCT02074384|B2|Baseline|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
667919|NCT02074384|B1|Baseline|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
667920|NCT02074384|P3|Participant Flow|Clinicians|Clinicians completing study AGP visits.
667921|NCT02074384|P2|Participant Flow|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
667922|NCT02074384|P1|Participant Flow|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
667923|NCT02074384|O3|Outcome|Clinicians|Clinicians completing the study visits.
667924|NCT02074384|O2|Outcome|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
667925|NCT02074384|O1|Outcome|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
667926|NCT02074384|E3|Reported Event|Clinicians|"Clinicians completing study visits.~Clinician: Survey of clinicians after study visits"
667927|NCT02074384|E2|Reported Event|Self Monitoring Blood Glucose|"Participants will self test for two weeks.~Self Monitoring Blood Glucose: Participants will use their own SMBG device."
667928|NCT02074384|E1|Reported Event|Continuous Glucose Monitoring|"Participants will wear Continuous Glucose Monitoring for two weeks.~Continuous Glucose Monitor: CGM device for measurement of interstitial glucose on a 24/7 continuous cycle."
667929|NCT02074358|B1|Baseline|All Treated Participants|Treated population included all participants who received at least one dose of study medication. Participants received 10 mg apixaban BID on Days 1-3 and on Day 4 received a single dose of 10 mg apixaban followed 3 hours later by an IV infusion of 50 IU/kg prothrombin complex concentrate (PCC) (which was either Cofact or Beriplex P/N) or the participant received an IV infusion of placebo (saline solution). Participants were randomized on Day 1 to one of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB and CBA). There were 3 treatment periods with a total of 3 participants in each of 3 sequences (ABC, ACB, CAB) and 2 participants in each of 3 other sequences (CBA, BAC, BCA) for a total of 15 participants who participated in this open label, randomized, crossover study.
667930|NCT02074358|P6|Participant Flow|Treatment CBA|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
667931|NCT02074358|P5|Participant Flow|Treatment CAB|"Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
668060|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
667932|NCT02074358|P4|Participant Flow|Treatment BCA|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes."
667933|NCT02074358|P3|Participant Flow|Treatment BAC|"Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
667934|NCT02074358|P2|Participant Flow|Treatment ACB|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID)Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Saline solution (placebo) 0 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes."
667935|NCT02074358|P1|Participant Flow|Treatment ABC|"Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet twice daily (BID) on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours (hrs) later by Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) intravenous infusion (IV) for 30 minutes.~Treatment B: Apixaban + Cofact [4-Factor prothrombin complex concentrate (PCC)]: Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Cofact (4-Factor PCC) 50 IU/kg IV infusion for 30 minutes.~Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; Day 4: Single 10 mg Dose Apixaban followed 3hrs later by Beriplex P/N (4-Factor PCC) 50 IU/kg IV infusion for 30 min."
667936|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667937|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667938|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667939|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667940|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667941|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667942|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667943|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667944|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667945|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667946|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667947|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667948|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667949|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667973|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667950|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667951|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667952|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667953|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667954|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667955|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667956|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667957|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667958|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667959|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667960|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667961|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667962|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667963|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667964|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667965|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667966|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667967|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667968|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667969|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667970|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667971|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667972|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668056|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
701284|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
667974|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667975|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667976|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667977|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667978|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667979|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667980|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667981|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667982|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667983|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667984|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667985|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667986|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667987|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667988|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667989|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667990|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667991|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667992|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667993|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
667994|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667995|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667996|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668057|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
668058|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
667997|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
667998|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
667999|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668000|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668001|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668002|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668003|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668004|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668005|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668006|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668007|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668008|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668009|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668010|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668011|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668012|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668013|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668014|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668015|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668016|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668017|NCT02074358|O3|Outcome|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668018|NCT02074358|O2|Outcome|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668019|NCT02074358|O1|Outcome|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668059|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668020|NCT02074358|E3|Reported Event|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC)|Treatment C: Apixaban + Beriplex P/N (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Beriplex P/N (4-Factor PCC) 50 IU/kg for 30 minutes.
668021|NCT02074358|E2|Reported Event|Treatment B: Apixaban + Cofact (4-Factor PCC)|Treatment B: Apixaban + Cofact (4-Factor PCC): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Cofact (4-Factor PCC) 50 IU/kg for 30 minutes.
668022|NCT02074358|E1|Reported Event|Treatment A: Apixaban + Placebo|Treatment A: Apixaban + Placebo (Saline solution): Apixaban 10 mg oral Tablet BID on Days 1- 3; on Day 4: Single 10 mg Dose Apixaban followed 3hours later by IV infusion of Saline solution (placebo) 0 international units per kilogram of body weight (IU/kg) for 30 minutes.
668023|NCT02074345|B1|Baseline|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668024|NCT02074345|P1|Participant Flow|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668025|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668026|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668027|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668028|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668029|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668030|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668031|NCT02074345|O1|Outcome|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668032|NCT02074345|E1|Reported Event|TAK-816 0.5 mL|Primary immunization: TAK-816 0.5 mL, intramuscular injection, once on Day 1 and every 28 days for 2 intervals (Days 29 and 57). Booster immunization: TAK-816 0.5 mL, intramuscular injection, once, 52 weeks after the third dose of primary immunization.
668033|NCT02074059|B7|Baseline|Total|Total of all reporting groups
668034|NCT02074059|B6|Baseline|nCPAP Alone|nCPAP therapy alone
668035|NCT02074059|B5|Baseline|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668036|NCT02074059|B4|Baseline|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of lucinactant for Inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668037|NCT02074059|B3|Baseline|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of lucinactant for inhalation with nCPAP
668038|NCT02074059|B2|Baseline|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of lucinactant for inhalation with nCPAP
668039|NCT02074059|B1|Baseline|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of lucinactant for inhalation with nCPAP
668040|NCT02074059|P6|Participant Flow|nCPAP Alone|"nCPAP therapy alone~nCPAP alone: nCPAP therapy"
668041|NCT02074059|P5|Participant Flow|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668042|NCT02074059|P4|Participant Flow|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668043|NCT02074059|P3|Participant Flow|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
668044|NCT02074059|P2|Participant Flow|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
668045|NCT02074059|P1|Participant Flow|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
668046|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
668047|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668048|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668049|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
668050|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
668051|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
668052|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
668053|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668054|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668055|NCT02074059|O3|Outcome|Aerosolized Lucinactant (High Dose)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
701285|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
668065|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668066|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668067|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
668068|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
668069|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
668070|NCT02074059|O6|Outcome|nCPAP Alone|nCPAP therapy alone
668071|NCT02074059|O5|Outcome|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668072|NCT02074059|O4|Outcome|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668073|NCT02074059|O3|Outcome|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
668074|NCT02074059|O2|Outcome|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
668075|NCT02074059|O1|Outcome|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
668076|NCT02074059|E6|Reported Event|nCPAP Alone|nCPAP therapy alone
668077|NCT02074059|E5|Reported Event|Aerosolized Lucinactant (150 mg/kg)|150 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668078|NCT02074059|E4|Reported Event|Aerosolized Lucinactant (100 mg/kg)|100 mg TPL/kg of Lucinactant for inhalation with nCPAP; 1 repeat dose allowed if repeat dosing criteria were met
668079|NCT02074059|E3|Reported Event|Aerosolized Lucinactant (75 mg/kg)|75 mg TPL/kg of Lucinactant for inhalation with nCPAP
668080|NCT02074059|E2|Reported Event|Aerosolized Lucinactant (50 mg/kg)|50 mg TPL/kg of Lucinactant for inhalation with nCPAP
668081|NCT02074059|E1|Reported Event|Aerolized Lucinactant (25 mg/kg)|25 mg TPL/kg of Lucinactant for inhalation with nCPAP
668082|NCT02073656|B1|Baseline|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
668083|NCT02073656|P1|Participant Flow|LDV/SOF 12 Weeks|"Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily for up to 12 weeks.~Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 24 weeks."
668084|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
668085|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
668086|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
668087|NCT02073656|O1|Outcome|LDV/SOF+RBV 24 Weeks (Retreatment Substudy)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
668088|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668089|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668090|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668091|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668092|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668093|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668094|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668095|NCT02073656|O1|Outcome|LDV/SOF 12 Weeks|Primary Study: LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668096|NCT02073656|E2|Reported Event|LDV/SOF+RBV 24 Weeks (Retreatment)|Participants who experienced confirmed post-treatment virologic failure (relapse) at or before Posttreatment Week 24 during the Primary Study were eligible to be enrolled in the Retreatment Substudy to receive LDV/SOF (90/400 mg) FDC tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks.
668097|NCT02073656|E1|Reported Event|LDV/SOF 12 Weeks (Primary Study)|LDV/SOF (90/400 mg) FDC tablet once daily for up to 12 weeks.
668098|NCT02073461|B4|Baseline|Total|Total of all reporting groups
668099|NCT02073461|B3|Baseline|Vehicle|"Vehicle~Vehicle"
668100|NCT02073461|B2|Baseline|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
668101|NCT02073461|B1|Baseline|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
668102|NCT02073461|P3|Participant Flow|Vehicle|"Vehicle~Vehicle"
668103|NCT02073461|P2|Participant Flow|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
668104|NCT02073461|P1|Participant Flow|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
668105|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
668106|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
668110|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
668111|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
668119|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
668120|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
668121|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
668122|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
668123|NCT02073461|O3|Outcome|Vehicle|"Vehicle~Vehicle"
668124|NCT02073461|O2|Outcome|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
668125|NCT02073461|O1|Outcome|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
668126|NCT02073461|E3|Reported Event|Vehicle|"Vehicle~Vehicle"
668127|NCT02073461|E2|Reported Event|CD1579 5%|"Benzoyl Peroxide 5%~CD1579 5%"
668128|NCT02073461|E1|Reported Event|CD1579 2.5%|"Benzoyl Peroxide 2.5%~CD1579 2.5%"
668129|NCT02073448|B4|Baseline|Total|Total of all reporting groups
668130|NCT02073448|B3|Baseline|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668131|NCT02073448|B2|Baseline|CD0271|"Adapalene 01% Gel~CD0271"
668132|NCT02073448|B1|Baseline|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668133|NCT02073448|P3|Participant Flow|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668134|NCT02073448|P2|Participant Flow|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668135|NCT02073448|P1|Participant Flow|CD0271|"Adapalene 01% Gel~CD0271"
668136|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668137|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
668138|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668139|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668140|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
668141|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668142|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668143|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
668144|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668145|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668146|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
668147|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668148|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668149|NCT02073448|O2|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
668150|NCT02073448|O1|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668151|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668152|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668153|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
668154|NCT02073448|O3|Outcome|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668155|NCT02073448|O2|Outcome|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668156|NCT02073448|O1|Outcome|CD0271|"Adapalene 01% Gel~CD0271"
668157|NCT02073448|E3|Reported Event|CD1579|"Benzoyl Peroxide 2.5% Gel~CD1579"
668158|NCT02073448|E2|Reported Event|GK530G|"Fixed-dose combination gel of Adapalene and Benzoyl Peroxide~GK530G"
668159|NCT02073448|E1|Reported Event|CD0271|"Adapalene 01% Gel~CD0271"
668160|NCT02072980|B1|Baseline|Overall|Delefilcon A contact lenses worn during Period 1 and Period 2
668161|NCT02072980|P2|Participant Flow|15min/16hr|Delefilcon A contact lenses worn bilaterally for 15 minutes in Period 1, follwed by 16 waking hours (1 day) in Period 2. A fresh pair of lenses was dispensed for Period 2.
668162|NCT02072980|P1|Participant Flow|16hr/15min|Delefilcon A contact lenses worn bilaterally for 16 waking hours (1 day) in Period 1, followed by 15 minutes in Period 2. A fresh pair of lenses was dispensed for Period 2.
668163|NCT02072980|O1|Outcome|15 Minutes|Delefilcon A contact lenses worn for 15 minutes during Period 1 or 2
668164|NCT02072980|O2|Outcome|Unworn|Unworn delefilcon A contact lenses removed from the commercial packaging and soaked overnight in phosphate buffered saline
668165|NCT02072980|O1|Outcome|16 Hours|Delefilcon A contact lenses worn for 16 hours in Period 1 or 2
668166|NCT02072980|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn during Period 1 and Period 2
668167|NCT02072421|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
668168|NCT02072421|P1|Participant Flow|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
668169|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
668170|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
668171|NCT02072421|O1|Outcome|PCI at a Hospital Without On-site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
668172|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
668173|NCT02072421|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
668174|NCT02072421|E1|Reported Event|PCI at Hospitals Without On-Site Cardiac Surgery|PCI at a hospital without on-site cardiac surgery
668175|NCT02072200|B1|Baseline|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
701286|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
668176|NCT02072200|P1|Participant Flow|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
668177|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
668178|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
668238|NCT02071823|B3|Baseline|Total|Total of all reporting groups
668179|NCT02072200|O1|Outcome|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
668180|NCT02072200|E1|Reported Event|Modified Release Prednisone|"Single arm / Lodotra~Lodotra®: Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response"
668181|NCT02072096|B3|Baseline|Total|Total of all reporting groups
668182|NCT02072096|B2|Baseline|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine dose is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
668183|NCT02072096|B1|Baseline|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668184|NCT02072096|P2|Participant Flow|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Insulin glargine is titrated according to treatment algorithm. Treatment may last up to 72 weeks.
668185|NCT02072096|P1|Participant Flow|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668186|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668187|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668188|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668189|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
668190|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668191|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668192|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668193|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
668211|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
701287|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
668194|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668290|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668291|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668195|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label.Treatment may last up to 72 weeks.
668196|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668197|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668198|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668199|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668200|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668201|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668202|NCT02072096|O2|Outcome|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668203|NCT02072096|O1|Outcome|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668204|NCT02072096|E2|Reported Event|Strategy B (Reference)|Participants will receive glimepiride and may receive basal insulin glargine as a first line injectable therapy. Medications allowed in this arm include: glimepiride, metformin, pioglitazone, acarbose, linagliptin, sitagliptin and basal insulin glargine. Choice of therapy is based on investigator's discretion. Treatment used in label. Dose titrated by treatment algorithm. Treatment may last up to 72 weeks.
668205|NCT02072096|E1|Reported Event|Strategy A (Glucose-Dependent)|Participants may receive oral and injectable therapies (glucagon-like peptide-1 receptor agonists [GLP-1 RA]) that exert a glucose-dependent mode of action. Medications allowed in this arm include: metformin, pioglitazone, acarbose, linagliptin, sitagliptin, liraglutide, exenatide once weekly (QW), and exenatide twice daily (BID). Choice of therapy is based on investigator's discretion. Treatment used in label. Treatment may last up to 72 weeks.
668206|NCT02071849|B1|Baseline|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668207|NCT02071849|P1|Participant Flow|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668208|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668209|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668210|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668286|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
701288|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
668212|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668292|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668213|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668214|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668215|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668216|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668217|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668218|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668219|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668220|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668221|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668222|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668223|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668224|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668225|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668226|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668227|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668228|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668229|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668230|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668231|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668232|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668233|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668234|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668235|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668236|NCT02071849|O1|Outcome|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668237|NCT02071849|E1|Reported Event|Aortic Valve Repair|"Implantation of HAART 200 Aortic Valve Annuloplasty Device for bicuspid aortic valve reconstruction~HAART 200 Aortic Valve Annuloplasty Device: Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device ."
668239|NCT02071823|B2|Baseline|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
668240|NCT02071823|B1|Baseline|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
668241|NCT02071823|P2|Participant Flow|Group B Fasted/Fed|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fasted Washout Period (7days) Period 2: Fed~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
668242|NCT02071823|P1|Participant Flow|Group A Fed/Fasted|"A single 50 mg dose of BIA 9-1067 (2 x 25 mg capsules) was to be administered on:~Period 1: Fed Washout Period (7days) Period 2: Fasted~BIA 9-1067: A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days."
668243|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
668244|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
668245|NCT02071823|O2|Outcome|Fasted Condition|Fasted condition period
668246|NCT02071823|O1|Outcome|Fed Conditions|Fed conditions period
668247|NCT02071823|O2|Outcome|Fed Condition|Fed condition period
668248|NCT02071823|O1|Outcome|Fasted Conditions|Fasted conditions period
668249|NCT02071823|E2|Reported Event|Fed Condition|Fed condition period
668250|NCT02071823|E1|Reported Event|Fasted Conditions|Fasted conditions period
668251|NCT02071810|B6|Baseline|Total|Total of all reporting groups
668252|NCT02071810|B5|Baseline|Placebo|"Placebo, PLC~Placebo"
668253|NCT02071810|B4|Baseline|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
668254|NCT02071810|B3|Baseline|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
668255|NCT02071810|B2|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
668256|NCT02071810|B1|Baseline|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
668257|NCT02071810|P5|Participant Flow|Placebo|"Placebo, PLC~Placebo"
668258|NCT02071810|P4|Participant Flow|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
668259|NCT02071810|P3|Participant Flow|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
668260|NCT02071810|P2|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
668261|NCT02071810|P1|Participant Flow|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
668262|NCT02071810|O5|Outcome|Placebo|"Placebo, PLC~Placebo"
668263|NCT02071810|O4|Outcome|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
668264|NCT02071810|O3|Outcome|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
668265|NCT02071810|O2|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
668266|NCT02071810|O1|Outcome|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
668267|NCT02071810|E5|Reported Event|Placebo|"Placebo, PLC~Placebo"
668268|NCT02071810|E4|Reported Event|BIA 9-1067 30 mg|"BIA 9-1067 (OPC, Opicapone) 30 mg~BIA 9-1067"
668269|NCT02071810|E3|Reported Event|BIA 9-1067 20 mg|"BIA 9-1067 (OPC, Opicapone) 20 mg~BIA 9-1067"
668270|NCT02071810|E2|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (OPC, Opicapone) 10 mg~BIA 9-1067"
668271|NCT02071810|E1|Reported Event|BIA 9-1067 5 mg|"BIA 9-1067 (OPC, Opicapone) 5 mg~BIA 9-1067"
668272|NCT02071771|B1|Baseline|Overall|Nelfilcon A and Etafilcon A toric contact lenses worn during Period 1 and Period 2, as randomized, in a crossover assignment.
668273|NCT02071771|P2|Participant Flow|1DAM A, Then DACP T|Etafilcon A toric contact lenses worn first, with Nelfilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
668274|NCT02071771|P1|Participant Flow|DACP T, Then 1DAM A|Nelfilcon A toric contact lenses worn first, with Etafilcon A toric contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 10 days.
668275|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
668276|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
668277|NCT02071771|O2|Outcome|1DAM A|Etafilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
668278|NCT02071771|O1|Outcome|DACP T|Nelfilcon A toric contact lenses worn bilaterally during Period 1 or Period 2 on a daily wear, daily disposable basis for 10 days.
668279|NCT02071771|E2|Reported Event|1DAM A|Etafilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
668280|NCT02071771|E1|Reported Event|DACP T|Nelfilcon A toric contact lenses worn bilaterally on a daily wear, daily disposable basis for 10 days.
668281|NCT02071108|B1|Baseline|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668282|NCT02071108|P1|Participant Flow|Lithoplasty Treatment|All subjects were treated with the Shockwave Medical Peripheral Lithoplasty System
668283|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668284|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668285|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668429|NCT02070237|B3|Baseline|Total|Total of all reporting groups
668287|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668288|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668289|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668293|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668294|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668295|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668296|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668297|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668298|NCT02071108|O1|Outcome|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668299|NCT02071108|E1|Reported Event|Lithoplasty Treatment|Shockwave Medical Peripheral Lithoplasty System
668300|NCT02071082|B3|Baseline|Total|Total of all reporting groups
668301|NCT02071082|B2|Baseline|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668302|NCT02071082|B1|Baseline|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668303|NCT02071082|P2|Participant Flow|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668304|NCT02071082|P1|Participant Flow|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet once daily with food for 48 weeks.
668305|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668306|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668307|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668308|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668309|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668310|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668311|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668312|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668313|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668314|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668315|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668316|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668317|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668318|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668319|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668320|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668321|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668322|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668323|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668324|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668325|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668326|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668327|NCT02071082|O2|Outcome|HIV-Suppressed|HIV/HBV coinfected participants who were HIV-suppressed received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668328|NCT02071082|O1|Outcome|HIV/HBV Treatment-Naive|HIV/HBV coinfected participants who were HIV treatment-naive and HBV treatment-naive received E/C/F/TAF (150/150/200/10 mg) FDC tablet once daily with food for 48 weeks.
668329|NCT02071082|E2|Reported Event|HIV-Suppressed|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV-suppressed)
707922|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
668330|NCT02071082|E1|Reported Event|HIV/HBV Treatment-Naive|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 48 weeks (HIV treatment-naive and HBV treatment-naive)
668331|NCT02070965|B4|Baseline|Total|Total of all reporting groups
668332|NCT02070965|B3|Baseline|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
668333|NCT02070965|B2|Baseline|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
668334|NCT02070965|B1|Baseline|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
668335|NCT02070965|P3|Participant Flow|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
668336|NCT02070965|P2|Participant Flow|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
668337|NCT02070965|P1|Participant Flow|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
668338|NCT02070965|O3|Outcome|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
668339|NCT02070965|O2|Outcome|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
668340|NCT02070965|O1|Outcome|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
668341|NCT02070965|E3|Reported Event|DFD01 Spray Group 2|"DFD01 Spray, bid, 14 days~DFD01 Spray"
668342|NCT02070965|E2|Reported Event|Comp01 Lotion|"Comp01 Lotion, bid, 14 days~Comp01 Lotion"
668343|NCT02070965|E1|Reported Event|DFD01 Spray Group 1|"DFD01 Spray, bid, 28 days~DFD01 Spray"
668344|NCT02070692|B3|Baseline|Total|Total of all reporting groups
668345|NCT02070692|B2|Baseline|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668346|NCT02070692|B1|Baseline|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668347|NCT02070692|P2|Participant Flow|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668348|NCT02070692|P1|Participant Flow|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668349|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668350|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668351|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668352|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668353|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668354|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668355|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668356|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668357|NCT02070692|O2|Outcome|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668358|NCT02070692|O1|Outcome|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668359|NCT02070692|E2|Reported Event|Placebo|"Placebo tablets twice daily for seven days, to be started on the third day of a bleeding episode.~Placebo: 7 day course of placebo during an episode of irregular vaginal bleeding"
668360|NCT02070692|E1|Reported Event|Tamoxifen|"Participants will be randomized to receive either tamoxifen 10mg twice daily for seven days, or placebo twice daily for seven days, to be started on the third day of an episode of bleeding.~Tamoxifen: 7 day course of tamoxifen during an episode of irregular vaginal bleeding"
668361|NCT02070640|B3|Baseline|Total|Total of all reporting groups
668362|NCT02070640|B2|Baseline|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668363|NCT02070640|B1|Baseline|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
669385|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
668364|NCT02070640|P2|Participant Flow|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668365|NCT02070640|P1|Participant Flow|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668366|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668367|NCT02070640|O1|Outcome|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668368|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668369|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668370|NCT02070640|O2|Outcome|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668371|NCT02070640|O1|Outcome|Non-Acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668372|NCT02070640|E2|Reported Event|Acute Cholecystitis|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668373|NCT02070640|E1|Reported Event|Non-acute|"Each subject enrolled in this study will undergo near-infrared cholangiography fluorescence (NIRF-C) and standard of care intraoperative cholangiography.~Injection of indocyanine green (ICG): 2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.~Near Infrared Cholangiography Fluorescence (NIRF-C): These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce."
668374|NCT02070380|B5|Baseline|Total|Total of all reporting groups
668375|NCT02070380|B4|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
668376|NCT02070380|B3|Baseline|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
668377|NCT02070380|B2|Baseline|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
668378|NCT02070380|B1|Baseline|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
668379|NCT02070380|P4|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.05 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
668380|NCT02070380|P3|Participant Flow|MultiHance 0.05 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.05 mmol/kg first
668381|NCT02070380|P2|Participant Flow|Dotarem 0.1 mmol/kg Then MultiHance 0.1 mmol/kg|Patients randomized to receive Dotarem 0.1 mmol/kg first
668382|NCT02070380|P1|Participant Flow|MultiHance 0.1 mmol/kg Then Dotarem 0.1 mmol/kg|Patients randomized to receive MultiHance 0.1 mmol/kg first
668383|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668384|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668385|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668386|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668387|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668388|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668389|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668390|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668391|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668392|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668393|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668394|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668395|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668396|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668397|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668398|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668399|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668400|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668401|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668402|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668403|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668404|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668405|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668406|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668407|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668408|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668409|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668410|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668411|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668412|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668413|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668414|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668415|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668416|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668417|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668418|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668419|NCT02070380|O6|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668420|NCT02070380|O5|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668421|NCT02070380|O4|Outcome|MultiHance 0.05 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.05 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668422|NCT02070380|O3|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 3)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668423|NCT02070380|O2|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 2)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668424|NCT02070380|O1|Outcome|MultiHance 0.1 mmol/kg Arm (Reader 1)|MRI with MultiHance 0.1 mmol/kg versus MRI with Dotarem 0.1 mmol/kg
668425|NCT02070380|E4|Reported Event|Study Arm 2 / Dotarem 0.1 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~54 (Dotarem as 1st injection) + 51 (Dotarem as 2nd injection) =105"
668426|NCT02070380|E3|Reported Event|Study Arm 2/ MultiHance 0.05 mmol/kg|"Study Arm 2: MultiHance 0.05 mmol/kg/ Experienced after dosed with MultiHance 0.05 mmol/kg.~53 (MH as 1st injection) + 51 (MH as 2nd injection) = 104"
668427|NCT02070380|E2|Reported Event|Study Arm 1 / Dotarem 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with Dotarem 0.1 mmol/kg.~39 (Dotarem as 1st injection) + 31 (Dotarem as 2nd injection) =70"
668428|NCT02070380|E1|Reported Event|Study Arm 1 / MultiHance 0.1 mmol/kg|"Study Arm 1: MultiHance 0.1 mmol/kg/ Experienced after dosed with MultiHance 0.1 mmol/kg.~31 (MH as 1st injection) + 34 (MH as 2nd injection) = 65"
668430|NCT02070237|B2|Baseline|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
669386|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
668431|NCT02070237|B1|Baseline|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668432|NCT02070237|P2|Participant Flow|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668433|NCT02070237|P1|Participant Flow|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668434|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668435|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668436|NCT02070237|O2|Outcome|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668437|NCT02070237|O1|Outcome|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668438|NCT02070237|E2|Reported Event|Enoxaparin Twice Daily|"This arm will have patients randomized to receive weight based (0.5 mg/kg) sub-cutaneous injection of Lovenox (enoxaparin) twice daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668439|NCT02070237|E1|Reported Event|Enoxaparin Once Daily|"This arm will have patients randomized to receive 40 mg sub-cutaneous injection of Lovenox (enoxaparin) once daily.~Enoxaparin: Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge."
668440|NCT02069093|B1|Baseline|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668441|NCT02069093|P1|Participant Flow|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668442|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668443|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668572|NCT02067533|O2|Outcome|Extension Position|soft tissue repair in extension position
668573|NCT02067533|O1|Outcome|Flexion Position|soft tissue repair in flexion position
668444|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668841|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
668445|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668446|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668447|NCT02069093|O1|Outcome|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668448|NCT02069093|E1|Reported Event|Dexamethasone Based Mouthwash|Participants swished and spat 10mL of 0.5mg/5mL dexamethasone steroid mouthwash (investigational treatment) 4 times daily (qid) orally for 2 minutes each for 8 weeks. Participants remained without food or drink (NPO) for one hour after administration of the mouthwash. Also, participants received everolimus 10 mg and exemstane 25 mg (study treatments) according to local regulations.
668449|NCT02068443|B4|Baseline|Total|Total of all reporting groups
668450|NCT02068443|B3|Baseline|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668451|NCT02068443|B2|Baseline|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668452|NCT02068443|B1|Baseline|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668453|NCT02068443|P3|Participant Flow|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668454|NCT02068443|P2|Participant Flow|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668455|NCT02068443|P1|Participant Flow|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668456|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668457|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668458|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668459|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668460|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668461|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668462|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668463|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668464|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668574|NCT02067533|E2|Reported Event|Extension Position|soft tissue repair in extension position
668575|NCT02067533|E1|Reported Event|Flexion Position|soft tissue repair in flexion position
668576|NCT02067273|B3|Baseline|Total|Total of all reporting groups
668465|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668466|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668467|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668468|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668469|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668470|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668471|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668472|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668473|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668474|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668475|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668476|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668477|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668478|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668479|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668480|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668481|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668482|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668483|NCT02068443|O3|Outcome|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668484|NCT02068443|O2|Outcome|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668485|NCT02068443|O1|Outcome|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668486|NCT02068443|E3|Reported Event|Alogliptin + Metformin Hydrochloride BID|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 250 mg BID (twice daily), tablets, orally, 1 tablet after breakfast and 1 tablet after dinner and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after breakfast for 24 weeks.
668577|NCT02067273|B2|Baseline|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
669357|NCT02061358|P4|Participant Flow|90 mg UV-4B|UV-4B 90 mg oral, single dose
668487|NCT02068443|E2|Reported Event|Alogliptin + Metformin Hydrochloride QD|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride 500 mg QD (250 mg x 2 tablets, once daily), tablets, orally, QD (once daily), after breakfast and 1 metformin hydrochloride placebo-matching, tablet, orally, once, daily, after dinner for 24 weeks.
668488|NCT02068443|E1|Reported Event|Alogliptin Alone|Alogliptin 25 mg, tablets, orally, once, daily, after breakfast and metformin hydrochloride placebo-matching, tablets, orally, 2 tablets after breakfast and 1 tablet after dinner for 24 weeks.
668489|NCT02068222|B1|Baseline|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
668490|NCT02068222|P1|Participant Flow|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
668491|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
668492|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
668493|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
668494|NCT02068222|O1|Outcome|ABT-450/r and ABT-530 Plus RBV|"ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) once daily (QD) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.~ABT-450/ritonavir (r): Tablet~ABT-530: Tablet~Ribavirin (RBV): Tablet"
668495|NCT02068222|E1|Reported Event|ABT-450/r and ABT-530 Plus RBV|ABT-450/r (150 mg/100 mg) once daily (QD) co-administered with ABT-530 (120 mg) QD plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
668496|NCT02067728|B3|Baseline|Total|Total of all reporting groups
668497|NCT02067728|B2|Baseline|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668498|NCT02067728|B1|Baseline|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668499|NCT02067728|P2|Participant Flow|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668500|NCT02067728|P1|Participant Flow|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668501|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668502|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668503|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668504|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668505|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668506|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668507|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668508|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668529|NCT02067585|B2|Baseline|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668509|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668510|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668511|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668512|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668513|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668514|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668515|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668516|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668517|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668518|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668519|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668520|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668521|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668522|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668523|NCT02067728|O2|Outcome|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668524|NCT02067728|O1|Outcome|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668525|NCT02067728|E2|Reported Event|FNPA Tool Intervention|"FNPA tool practice intervention comprising of two components: 1) FNPA assessment which screens for obesigenic behaviors; 2) Brief Action Planning conversation designed to assist the family develop a health behavior change goal based on obesigenic risks on the assessment tool.~FNPA tool: Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits."
668526|NCT02067728|E1|Reported Event|Usual Care|"Usual care is provided to patients in practice groups not undergoing intervention of FNPA tool~Usual Care: Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits."
668527|NCT02067585|B4|Baseline|Total|Total of all reporting groups
668528|NCT02067585|B3|Baseline|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668578|NCT02067273|B1|Baseline|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
668530|NCT02067585|B1|Baseline|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668531|NCT02067585|P3|Participant Flow|Control|no-operated
668532|NCT02067585|P2|Participant Flow|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668533|NCT02067585|P1|Participant Flow|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668534|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668535|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668536|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668537|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668538|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668539|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668540|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668541|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668542|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668543|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668544|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668545|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668546|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668547|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668548|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668549|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
669387|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
668550|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668551|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668552|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668553|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668554|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668555|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668556|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668557|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668558|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668559|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668560|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668561|NCT02067585|O3|Outcome|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668562|NCT02067585|O2|Outcome|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668563|NCT02067585|O1|Outcome|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668564|NCT02067585|E3|Reported Event|Control|"Standardized Lipid meals will be served to the no-operated patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668565|NCT02067585|E2|Reported Event|LRYGB|"Standardized Lipid meals will be served to the Laparoscopic Rou-en-Y gastric bypass patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668566|NCT02067585|E1|Reported Event|LAGB|"Standardized Lipid meals will be served to Laparoscopic adjustable gastric banding patients.~Standardized Lipid meals: Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins."
668567|NCT02067533|B3|Baseline|Total|Total of all reporting groups
668568|NCT02067533|B2|Baseline|Extension Position|soft tissue repair in extension position
668569|NCT02067533|B1|Baseline|Flexion Position|soft tissue repair in flexion position
668570|NCT02067533|P2|Participant Flow|Extension Position|soft tissue repair in extension position
668571|NCT02067533|P1|Participant Flow|Flexion Position|soft tissue repair in flexion position
668579|NCT02067273|P2|Participant Flow|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
668580|NCT02067273|P1|Participant Flow|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
668581|NCT02067273|O2|Outcome|TMS Intervention (5 Days)|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
668582|NCT02067273|O1|Outcome|TMS Intervention (1 Day)|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
668583|NCT02067273|E2|Reported Event|TMS Intervention for 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once a day for 5 days~Transcranial Magnetic Stimulation (TMS)"
668584|NCT02067273|E1|Reported Event|TMS Intervention for 1 Day|"Application of Transcranial Magnetic Stimulation (TMS) for 1 day~Transcranial Magnetic Stimulation (TMS)"
668585|NCT02066922|B1|Baseline|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
668586|NCT02066922|P1|Participant Flow|DAILIES TOTAL1/TRUEYE|Delefilcon A and narafilcon A contact lenses (1 in each eye) worn in a daily wear, daily disposable mode approximately 8 hours a day for approximately 1 week.
668587|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
668588|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
668589|NCT02066922|O2|Outcome|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week.
668590|NCT02066922|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
668591|NCT02066922|E2|Reported Event|TRUEYE|Narafilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
668592|NCT02066922|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lens worn in 1 eye approximately 8 hours a day for 1 week
668593|NCT02066857|B3|Baseline|Total|Total of all reporting groups
668594|NCT02066857|B2|Baseline|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668595|NCT02066857|B1|Baseline|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
668596|NCT02066857|P2|Participant Flow|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668597|NCT02066857|P1|Participant Flow|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
668598|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668599|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
668600|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668601|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668602|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668603|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668604|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
668605|NCT02066857|O1|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668606|NCT02066857|O2|Outcome|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668607|NCT02066857|O1|Outcome|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
668608|NCT02066857|E2|Reported Event|"Generic Off the Shelf Removable Splint Group"|"Participants were randomized to receive a generic off the shelf removable splint for treatment of non-displaced distal radius fracture for 6 weeks."
668609|NCT02066857|E1|Reported Event|Generic Plaster or Fiberglass Cast Group|Participants were randomized to receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture for 6 weeks.
668610|NCT02066740|B1|Baseline|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
668611|NCT02066740|P1|Participant Flow|EverFlex™ Stent With Entrust™ Delivery System|Subjects were treated with the EverFlex™ stent with Entrust™ delivery system
668612|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
668613|NCT02066740|O1|Outcome|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
668614|NCT02066740|E1|Reported Event|EverFlex™ Stent With Entrust™ Delivery System|EverFlex™ stent with Entrust™ delivery system
668615|NCT02066727|B3|Baseline|Total|Total of all reporting groups
668616|NCT02066727|B2|Baseline|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
668617|NCT02066727|B1|Baseline|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
669358|NCT02061358|P3|Participant Flow|30 mg UV-4B|UV-4B 30 mg oral, single dose
668618|NCT02066727|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
668619|NCT02066727|P1|Participant Flow|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
669388|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
668620|NCT02066727|O2|Outcome|Dexmedetomidine|"Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.~Dexmedetomidine: Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg."
668621|NCT02066727|O1|Outcome|Normal Saline|"Normal Saline is administrated as an adjuvant of lidocaine.~Normal Saline: Normal Saline is administrated as an adjuvant of lidocaine."
668622|NCT02066727|E2|Reported Event|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
668623|NCT02066727|E1|Reported Event|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
668624|NCT02066402|B3|Baseline|Total|Total of all reporting groups
668625|NCT02066402|B2|Baseline|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668626|NCT02066402|B1|Baseline|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668627|NCT02066402|P2|Participant Flow|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668628|NCT02066402|P1|Participant Flow|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668629|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668630|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668631|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668632|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668633|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668634|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668635|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668636|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668637|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668638|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668639|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668640|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668641|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668642|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668643|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668644|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668645|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668646|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668647|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668648|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668649|NCT02066402|O2|Outcome|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668650|NCT02066402|O1|Outcome|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668651|NCT02066402|E2|Reported Event|Linezolid|Participants received 600 mg Linezolid twice daily I.V. infusion to oral for 10 days
668652|NCT02066402|E1|Reported Event|Tedizolid Phosphate (Sivextro, BAY119-2631)|Participants received 200 mg Tedizolid Phosphate once daily intravenous (I.V.) infusion to oral for 6 days, followed by 4 days of placebo
668653|NCT02066051|B1|Baseline|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
668677|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
669061|NCT02063230|E1|Reported Event|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
668678|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
669389|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
668654|NCT02066051|P1|Participant Flow|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
668655|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
668656|NCT02066051|O1|Outcome|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
668657|NCT02066051|E1|Reported Event|IPL Treatment|"Subjects who had inactive chronic graft versus host disease (GVHD) after allogeneic bone marrow transplantation and severe dry eye symptoms related to ocular rosacea unresponsive to conventional management were recruited. Subjects were treated with 4 monthly sessions of intense pulsed light (IPL) and meibomian gland expression.~IPL: Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.~Meibomian Gland Expression: After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands."
668658|NCT02065453|B3|Baseline|Total|Total of all reporting groups
668659|NCT02065453|B2|Baseline|Disposable Device Right and Reusable Devices Left|25 women were randomized to receive disposable device right and reusable devices left
668660|NCT02065453|B1|Baseline|Disposable Device Left and Resusable Devices Right|27 women were randomized to receive disposable device left and resusable devices right
668661|NCT02065453|P2|Participant Flow|Disposable Device - Right & Reusable Devices - Left|25 women were randomized to attending physicians using the disposable device on the right and reusable devices on the left
668662|NCT02065453|P1|Participant Flow|Disposable Device - Left & Reusable Devices - Right|27 women were randomized to attending physicians using the disposable device on the left and reusable devices on the right.
668663|NCT02065453|O2|Outcome|Reusable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
668664|NCT02065453|O1|Outcome|Disposable|Uterine Vessel Desiccation and Electrosurgical Cutting Time (min) Resident and Attending Physicians Combined
668665|NCT02065453|E1|Reported Event|Disposable or Reusable Energy Sources|Each patient serve as their own control. One side of the uterine attachments would be transected using the disposable device, the Ligasure, and the other using the two reusable devices, the Robi bipolar and Storz laparoscopic shears. It is our standard practice that the attending surgeon is on the patient's left side while the resident physician is on the patients right. To eliminate the bias of surgical experience, we will randomize the energy source used on each side for every case. Therefore, the number of cases performed by the attending surgeon with the disposable or reusable energy sources, will equal that of the less experienced resident surgeon.
668666|NCT02064985|B4|Baseline|Total|Total of all reporting groups
668667|NCT02064985|B3|Baseline|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668668|NCT02064985|B2|Baseline|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668669|NCT02064985|B1|Baseline|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668670|NCT02064985|P3|Participant Flow|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668671|NCT02064985|P2|Participant Flow|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668672|NCT02064985|P1|Participant Flow|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668673|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668674|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668675|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668676|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
669062|NCT02063035|B3|Baseline|Total|Total of all reporting groups
668679|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668680|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668681|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668682|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668683|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668684|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668685|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668686|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668687|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668688|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668689|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668690|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668691|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668692|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668693|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668694|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668695|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668696|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668697|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668698|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668699|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668700|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668701|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668702|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668703|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668704|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668705|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668706|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668707|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668708|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668709|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668710|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668711|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668712|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668713|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668714|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668715|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668716|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668717|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668718|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
669359|NCT02061358|P2|Participant Flow|10 mg UV-4B|UV-4B 10 mg oral, single dose
668719|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668720|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668721|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668722|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668723|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668724|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668725|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668726|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668727|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668728|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668729|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668730|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668731|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668732|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668733|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668734|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668735|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668736|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668737|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668738|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668739|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668740|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668741|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668742|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668743|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668744|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668745|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668746|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668747|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668748|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668749|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668750|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668751|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668752|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668753|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668754|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668755|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668756|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668757|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668758|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668759|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
669360|NCT02061358|P1|Participant Flow|3 mg UV-4B|UV-4B 3 mg oral, single dose
668760|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668761|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668762|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668763|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668764|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668765|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668766|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668767|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668768|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668769|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668770|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668771|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668772|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668773|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668774|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668775|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668776|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668777|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668778|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668779|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668780|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668781|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668782|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668783|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668784|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668785|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668786|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668787|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668788|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668789|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668790|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668791|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668792|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668793|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668794|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668795|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668796|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668797|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668798|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668799|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668800|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
669361|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
668801|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668802|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668803|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668804|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668805|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668806|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668807|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668808|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668809|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668810|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668811|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668812|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668813|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668814|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668815|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668816|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668817|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668818|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668819|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668820|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668821|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668822|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668823|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668824|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668825|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668826|NCT02064985|O3|Outcome|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668827|NCT02064985|O2|Outcome|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668828|NCT02064985|O1|Outcome|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668829|NCT02064985|E3|Reported Event|Ticagrelor 90mg|A single dose of ticagrelor 90 mg on Day 1 followed by 90 mg twice daily (bid) on Days 3-6 and a 90mg single dose on Day 7.
668830|NCT02064985|E2|Reported Event|Ticagrelor 60mg|A single dose of ticagrelor 60 mg on Day 1 followed by 60 mg twice daily (bid) on Days 3-6 and a 60mg single dose on Day 7.
668831|NCT02064985|E1|Reported Event|Ticagrelor 45mg|A single dose of ticagrelor 45 mg on Day 1 followed by 45 mg twice daily (bid) on Days 3-6 and a 45mg single dose on Day 7.
668832|NCT02064907|B3|Baseline|Total|Total of all reporting groups
668833|NCT02064907|B2|Baseline|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
668834|NCT02064907|B1|Baseline|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
668835|NCT02064907|P2|Participant Flow|Dexlansoprazole Capsules + Dexlansoprazole OD Tablets|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 2.
668836|NCT02064907|P1|Participant Flow|Dexlansoprazole OD Tablets + Dexlansoprazole Capsules|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days in Period 1, followed by a 7 day washout period, followed by one dexlansoprazole 60 mg, capsule, orally, once daily for 5 days in Period 2.
668837|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
668838|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
668839|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
668840|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
668842|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
668843|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
668844|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
668845|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
668846|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
668847|NCT02064907|O2|Outcome|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
668848|NCT02064907|O1|Outcome|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
668849|NCT02064907|E2|Reported Event|Dexlansoprazole Capsules|Dexlansoprazole 60 mg, capsules, orally, once daily for 5 days.
668850|NCT02064907|E1|Reported Event|Dexlansoprazole OD Tablets|Two dexlansoprazole 30 mg, delayed-release orally disintegrating tablets, orally, once daily for 5 days.
668851|NCT02064231|B1|Baseline|Overall Study Population|
668852|NCT02064231|P4|Participant Flow|Oloplast Test A, Coloplast Test D, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test D and finally their own product for 14 days~Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test D: Coloplast Test D is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
668853|NCT02064231|P3|Participant Flow|Coloplast Test D, Coloplast Test C, Own Product|"The subjects first test Coloplast Test D and thereafter Coloplast Test C and finally their own product for 14 days~Coloplast Test D: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test C: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
668854|NCT02064231|P2|Participant Flow|Coloplast Test C , Coloplast Test D, Own Product|"The subjects first test Coloplast Test C and thereafter Coloplast Test D and finally their own product for 14 days~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.~Coloplast Test C: Coloplast Test C is a new ostomy appliance developed by Coloplast A/S~Coloplast Test D: Coloplast Test D is a new ostomy appliance developed by Coloplast A/S"
668855|NCT02064231|P1|Participant Flow|Coloplast Test A, Coloplast Test B, Own Product|"The subjects first test Coloplast Test A and thereafter Coloplast Test B and finally their own product for 14 days~Coloplast Test A: Coloplast Test A is a new ostomy appliance developed by Coloplast A/S~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S~Own product: Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others."
668856|NCT02064231|O5|Outcome|Own Product|Subjects collecting data on own product
668857|NCT02064231|O4|Outcome|Coloplast Test D|Subjects testing Test D
668858|NCT02064231|O3|Outcome|Coloplast Test C|Subjects testing Test C
668859|NCT02064231|O2|Outcome|Coloplast Test B|Subjects testing Test B
668860|NCT02064231|O1|Outcome|Coloplast Test A|Subjects testing Test A
668861|NCT02064231|E5|Reported Event|Own Product|Subjects collecting data on own product
668862|NCT02064231|E4|Reported Event|Coloplast Test D|Subjects testing Test D
668863|NCT02064231|E3|Reported Event|Coloplast Test C|Subjects testing Test C
668864|NCT02064231|E2|Reported Event|Coloplast Test B|Subjects testing Test B
668865|NCT02064231|E1|Reported Event|Coloplast Test A|Subjects testing Test A
668866|NCT02064205|B1|Baseline|Overall Baseline Charactistics of 32 Slightly Overweight Women|Baseline data of the subjects were measured at screening at least one week before the start of the study.
668867|NCT02064205|P1|Participant Flow|All Study Participants|"A: Breakfast with the pre-load and 12.5 g polydextrose B:Breakfast with the pre-load without polydextrose C: Breakfast and pre-load with 12.5 g polydextrose at 150 min D:Breakfast and pre-load without polydextrose at t=150 min~Eight orders:~A-B-D-C; B-C-A-D; C-D-B-A; D-A-C-B; A-D-B-C; C-B-D-A; B-A-C-D; D-C-A-B."
668868|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
668869|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|Breakfast with polydextrose and yogurt provided four hours before lunch.
668870|NCT02064205|O4|Outcome|Pre-load With Glucose Syrup Before Lunch [D]|Pre-load with glucose syrup and yogurt was provided 1.5h before lunch.
668871|NCT02064205|O3|Outcome|Pre-load With Polydextrose Before Lunch [C]|Pre-load with polydextrose syrup and yogurt is provided 1.5h before lunch
668872|NCT02064205|O2|Outcome|Glucose Syrup as Proload With Breakfast (Control) [B]|Breakfast with glucose syrup and yogurt provided four hours before lunch.
668873|NCT02064205|O1|Outcome|Polydextrose Syrup Preload With Yogurt With Breakfast [A]|Polydextrose syrup preload with yogurt with breakfast was consumed four hours before lunch
668874|NCT02064205|O4|Outcome|Pre-load With Yogurt and Glucose Before Lunch [D]|"Breakfast without pre-load. Pre-load with yogurt and glucose (control) provided 1.5h before lunch.~Yogurt with control (glucose syrup) is tested for its satiating effect 1.5h before lunch"
668875|NCT02064205|O3|Outcome|Pre-load With Polydextroseglucose Before Lunch [C]|"Breakfast without pre-load. Pre-load with yogurt and polydextrose provided 1.5h before lunch.~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt 1.5h before lunch."
669095|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
669362|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
668876|NCT02064205|O2|Outcome|Glucose Syrup at Breakfast (Control) [B]|"Breakfast with control pre-load four hours before lunch~Yogurt with control (glucose syrup) is tested for its satiating effect.~glucose syrup: Glucose syrup is used a control product for the polydextrose"
668877|NCT02064205|O1|Outcome|Polydextrose Syrup at Breakfast [A]|"Breakfast with pre-load four hours before lunch~12.5 g polydextrose: Appetite suppressing supplement is added in yogurt and provided with breakfast, four hours before lunch."
668878|NCT02064205|E4|Reported Event|Condition D|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and glucose syrup
668879|NCT02064205|E3|Reported Event|Condition C|Breakfast without preload; pre-load provided at t=150 min as a mid-morning snack of yogurt and polydextrose
668880|NCT02064205|E2|Reported Event|Condition B|Breakfast with preload of yogurt and glucose control
668881|NCT02064205|E1|Reported Event|Condition A|Breakfast with preload of yogurt and polydextrose
668882|NCT02063854|B8|Baseline|Total|Total of all reporting groups
668883|NCT02063854|B7|Baseline|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668884|NCT02063854|B6|Baseline|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668885|NCT02063854|B5|Baseline|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668886|NCT02063854|B4|Baseline|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668887|NCT02063854|B3|Baseline|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668888|NCT02063854|B2|Baseline|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668889|NCT02063854|B1|Baseline|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668890|NCT02063854|P7|Participant Flow|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668891|NCT02063854|P6|Participant Flow|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668892|NCT02063854|P5|Participant Flow|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668893|NCT02063854|P4|Participant Flow|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668894|NCT02063854|P3|Participant Flow|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
669363|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669122|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
668895|NCT02063854|P2|Participant Flow|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668896|NCT02063854|P1|Participant Flow|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668897|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668898|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668899|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668900|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668901|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668902|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668903|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668904|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668905|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668906|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668907|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668908|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668979|NCT02063737|B1|Baseline|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668909|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668910|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668911|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668912|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668913|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668914|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668915|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668916|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668917|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668918|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668919|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668920|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668921|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668922|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668991|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668923|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668924|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668925|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668926|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668927|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668928|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668929|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668930|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668931|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668932|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668933|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668934|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668935|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668936|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
669003|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668937|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668938|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668939|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668940|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668941|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668942|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668943|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668944|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668945|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668946|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668947|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668948|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668949|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668950|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
669053|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669054|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
668951|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668952|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668953|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668954|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668955|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668956|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668957|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668958|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668959|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668960|NCT02063854|O7|Outcome|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668961|NCT02063854|O6|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668962|NCT02063854|O5|Outcome|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668963|NCT02063854|O4|Outcome|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668964|NCT02063854|O3|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
669055|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669056|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
668965|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668966|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668967|NCT02063854|O3|Outcome|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668968|NCT02063854|O2|Outcome|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668969|NCT02063854|O1|Outcome|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668970|NCT02063854|E7|Reported Event|NE-58095 DR 37.5 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668971|NCT02063854|E6|Reported Event|NE-58095 DR 37.5 mg Once Monthly Following Breakfast|NE-58095 DR 37.5 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668972|NCT02063854|E5|Reported Event|NE-58095 DR 37.5 mg Once Monthly on Awakening|NE-58095 DR 37.5 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668973|NCT02063854|E4|Reported Event|NE-58095 DR 25 mg Once Monthly 30 Min. After Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668974|NCT02063854|E3|Reported Event|NE-58095 DR 25 mg Once Monthly Following Breakfast|NE-58095 DR 25 mg tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668975|NCT02063854|E2|Reported Event|NE-58095 DR 25 mg Once Monthly on Awakening|NE-58095 DR 25 mg tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast + NE-58095 IR placebo-matching tablet, orally, once, daily, at time of wakening, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668976|NCT02063854|E1|Reported Event|NE-58095 IR 2.5 mg Once Daily on Awakening|NE-58095 immediate release (IR) 2.5 mg tablet, orally, once, daily, at time of wakening + NE-58095 delayed release (DR) placebo-matching tablet, orally, once, monthly, at time of wakening + NE-58095 DR placebo-matching tablet, orally, once, monthly, following breakfast + NE-58095 DR placebo-matching tablet, orally, once, monthly, 30 minutes after breakfast, for up to 12 months. Calcium lactate hydrate 195 mg, once, daily, after dinner was taken as a background medication.
668977|NCT02063737|B3|Baseline|Total|Total of all reporting groups
668978|NCT02063737|B2|Baseline|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669057|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669364|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
668980|NCT02063737|P2|Participant Flow|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668981|NCT02063737|P1|Participant Flow|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668982|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668983|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668984|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668985|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668986|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668987|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668988|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668989|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668990|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669058|NCT02063230|E4|Reported Event|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669365|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
668992|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668993|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668994|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668995|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668996|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668997|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
668998|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
668999|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
669000|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669001|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
669002|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669059|NCT02063230|E3|Reported Event|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669366|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669004|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669005|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
669006|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669007|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
669008|NCT02063737|O2|Outcome|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669009|NCT02063737|O1|Outcome|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
669010|NCT02063737|E2|Reported Event|Intervention Group|"The intervention group will receive the same text-message queries as the control group. In addition, these subjects will receive suggestions (strategies) for reducing fatigue and sleepiness during shift work if they report a high-level of fatigue or sleepiness at the start or during their shift. These subjects will then receive additional text-message queries at the end of their shifts to determine if they adopted a strategy for reducing perceived sleepiness or fatigue.~Text-message strategies: If an intervention subject reports a high level of sleepiness or fatigue at the start or during their shift work, these subjects will receive additional text-messages that include strategies (suggestions) for reducing perceived fatigue or sleepiness during shift work. These subjects will also receive an additional text-message at the end of their shift to determine if the subject adopted the strategy suggested and if it helped reduced perceived fatigue or sleepiness."
669011|NCT02063737|E1|Reported Event|Control Group|The control group will receive text-message queries at the start, during, and end of shift. These queries will attempt to capture the worker's self-reported sleepiness, fatigue, and occurrence of work-related injury during shift work.
669012|NCT02063516|B3|Baseline|Total|Total of all reporting groups
669013|NCT02063516|B2|Baseline|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
669014|NCT02063516|B1|Baseline|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
669015|NCT02063516|P2|Participant Flow|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
669016|NCT02063516|P1|Participant Flow|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
669017|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
669060|NCT02063230|E2|Reported Event|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669367|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669018|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
669019|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
669020|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
669021|NCT02063516|O2|Outcome|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
669022|NCT02063516|O1|Outcome|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
669023|NCT02063516|E2|Reported Event|Proseal|"Device:Proseal Laryngeal Mask Airway~Proseal Laryngeal Mask Airway: Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube"
669024|NCT02063516|E1|Reported Event|Guardian|"Device: Guardian Laryngeal Mask~Guardian Laryngeal Mask: Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients."
669025|NCT02063230|B5|Baseline|Total|Total of all reporting groups
669026|NCT02063230|B4|Baseline|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669027|NCT02063230|B3|Baseline|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669028|NCT02063230|B2|Baseline|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669029|NCT02063230|B1|Baseline|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669030|NCT02063230|P4|Participant Flow|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669031|NCT02063230|P3|Participant Flow|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669032|NCT02063230|P2|Participant Flow|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669033|NCT02063230|P1|Participant Flow|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669034|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669035|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669036|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669037|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669038|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669039|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669040|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669041|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669042|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669043|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669044|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669045|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669046|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669047|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669048|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669049|NCT02063230|O1|Outcome|Mild|Mild (Child Pugh A) hepatic impaired subjects (all subjects received Selumetinib 50 mg)
669050|NCT02063230|O4|Outcome|Normal|Healthy volunteers. All volunteers received Selumetinib 50mg.
669051|NCT02063230|O3|Outcome|Severe|Severe (Child Pugh C) hepatic impaired subjects. All subjects received Selumetinib 20mg.
669052|NCT02063230|O2|Outcome|Moderate|Moderate (Child Pugh B) hepatic impaired subjects). 6 subjects received Selumetinib 50 mg, 2 received Selumetinib 25mg
669063|NCT02063035|B2|Baseline|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669064|NCT02063035|B1|Baseline|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669065|NCT02063035|P2|Participant Flow|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669066|NCT02063035|P1|Participant Flow|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 grams (g) tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669067|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669068|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669069|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669070|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669071|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669072|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669073|NCT02063035|O2|Outcome|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669074|NCT02063035|O1|Outcome|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669075|NCT02063035|E2|Reported Event|Placebo|Participants undergoing spinal surgery received a single, topical dose of matching placebo. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669076|NCT02063035|E1|Reported Event|Tranexamic Acid|Participants undergoing spinal surgery received a single, topical dose of 3 g tranexamic acid. The surgeon irrigated the study medication in the wound prior to closure, and aspirated it after five minutes. Drains were placed after the study drug was aspirated.
669077|NCT02062905|B3|Baseline|Total|Total of all reporting groups
669078|NCT02062905|B2|Baseline|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
669079|NCT02062905|B1|Baseline|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
669080|NCT02062905|P2|Participant Flow|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
669081|NCT02062905|P1|Participant Flow|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
669082|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
669083|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
669084|NCT02062905|O2|Outcome|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
669085|NCT02062905|O1|Outcome|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
669086|NCT02062905|E2|Reported Event|Placebo Plug Delivery Vehicle|"Placebo Plug with no drug~Placebo Plug with no drug"
669087|NCT02062905|E1|Reported Event|OTX-DP Treatment|"OTX-DP (sustained release dexamethasone, 0.4 mg)~OTX-DP treatment"
669088|NCT02062801|B3|Baseline|Total|Total of all reporting groups
669089|NCT02062801|B2|Baseline|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
669090|NCT02062801|B1|Baseline|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
669091|NCT02062801|P2|Participant Flow|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
669092|NCT02062801|P1|Participant Flow|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
669093|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
669094|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
669368|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669096|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
669097|NCT02062801|O2|Outcome|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
669098|NCT02062801|O1|Outcome|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
669099|NCT02062801|E2|Reported Event|Normal Saline Control Group|"1ml normal saline intravenously once at time of combined spinal epidural insertion~Placebo"
669100|NCT02062801|E1|Reported Event|Prophylactic Ephedrine|"Ephedrine 10mg iv once at time of combined spinal epidural insertion~Ephedrine: Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea"
669101|NCT02062710|B1|Baseline|Diphenhydramine/Phenylephrine/Cocoa, Dextromethorphan,Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; dextromethorphan; placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine~Dextromethorphan: 30 mg dose dextromethorphan"
669102|NCT02062710|P6|Participant Flow|Placebo, Dextromethorphan, Then Diphenhydramine/Phenylephrine/|"placebo, then dextromethorphan 30 mg, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods."
669103|NCT02062710|P5|Participant Flow|Placebo, Diphenhydramine/Phenylephrine/Cocoa, Then Dextrometho|"placebo, then diphenhydramine 25 mg and phenylephrine 10 mg, then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge 2 hours after study drug administration.~Washout period 1-2 days after each of the 3 dosing periods"
669104|NCT02062710|P4|Participant Flow|Dextromethorphan, Placebo, Then Diphenhydramine/Phenylephrine/|"dextromethorphan 30 mg, then placebo, then diphenhydramine 25 mg and phenylephrine 10 mg.~Intervention: capsaicin cough challenge 2 hours after study drug ingestion. Washout period 1-2 days between each of the 3 dosing periods"
669105|NCT02062710|P3|Participant Flow|Dextromethorphan, Diphenhydramine/Phenylephrine/Cocoa, Then pl|dextromethorphan 30 mg, then diphenhydramine/phenylephrine/cocoa, then placebo. Intervention: capsaicin cough challeneg 2 hours after study drug ingestion
669106|NCT02062710|P2|Participant Flow|Diphenhydramine/Phenylephrine/Cocoa, Then Placebo, Then Dextro|"diphenhydramine 25 mg and phenylephrine 10 mg; then placebo; then dextromethorphan 30 mg.~Intervention: capsaicin cough challenge testing after study drug ingestion"
669107|NCT02062710|P1|Participant Flow|Diphenhydramine/Phen/Cocoa, Dextromethorphan, Then Placebo|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup; then dextromethorphan 30 mg; then placebo.~Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Washout 1-2 days between each of the 3 dosing periods."
669108|NCT02062710|O3|Outcome|Placebo|placebo liquid, dextrose in water, 20 mL
669109|NCT02062710|O2|Outcome|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
669110|NCT02062710|O1|Outcome|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
669111|NCT02062710|E3|Reported Event|Placebo|placebo liquid, dextrose in water, 20 mL
669112|NCT02062710|E2|Reported Event|Dextromethorphan|"Dextromethorphan syrup, 30 mg dose. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Dextromethorphan: 30 mg dose dextromethorphan"
669113|NCT02062710|E1|Reported Event|Diphenhydramine/Phenylephrine/Cocoa|"Diphenhydramine 25 mg, phenylephrine 10 mg, in naturally-flavored cocoa syrup. Intervention: capsaicin cough challenge testing 2 hours after study drug ingestion.~Phenylephrine: 10 mg dose phenylephrine~Diphenhydramine: 25 mg dose diphenhydramine"
669114|NCT02062658|B1|Baseline|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
669115|NCT02062658|P1|Participant Flow|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
669116|NCT02062658|O1|Outcome|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
669117|NCT02062658|E1|Reported Event|Ketamine, Exposure & Response Prevention|"0.5mg/kg IV Ketamine infusion followed by condensed course of Exposure and Response Prevention (EX/RP)~Ketamine: 0.5mg/kg IV~Exposure and Response Prevention: A type of Cognitive Behavioral Therapy called Exposure and Response Prevention."
669118|NCT02062645|B1|Baseline|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
669119|NCT02062645|P1|Participant Flow|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
669120|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
669121|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
669123|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
669124|NCT02062645|O1|Outcome|Amlodipine/Valsartan|All patients received amlodipine/valsartan 5/160 mg daily at Day 0 and were up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (week 4) if their hypertension was not controlled. The duration of treatment period was 8 weeks.
669125|NCT02062645|E1|Reported Event|Amlodipine/Valsartan|amlodipine/valsartan
669126|NCT02062580|B3|Baseline|Total|Total of all reporting groups
669127|NCT02062580|B2|Baseline|Early BCG|"BCG at birth; standard of care~BCG"
669128|NCT02062580|B1|Baseline|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
669129|NCT02062580|P2|Participant Flow|Early BCG|"BCG at birth; standard of care~BCG"
669130|NCT02062580|P1|Participant Flow|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
669131|NCT02062580|O2|Outcome|Early BCG|"BCG at birth; standard of care~BCG"
669132|NCT02062580|O1|Outcome|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
669133|NCT02062580|O2|Outcome|Early BCG|"BCG at birth; standard of care~BCG"
669134|NCT02062580|O1|Outcome|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
669135|NCT02062580|E2|Reported Event|Early BCG|"BCG at birth; standard of care~BCG"
669136|NCT02062580|E1|Reported Event|Delayed BCG|"BCG delayed to 8 weeks of age~BCG"
669137|NCT02062502|B3|Baseline|Total|Total of all reporting groups
669138|NCT02062502|B2|Baseline|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669139|NCT02062502|B1|Baseline|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669140|NCT02062502|P2|Participant Flow|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669141|NCT02062502|P1|Participant Flow|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669142|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669143|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669144|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669145|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669146|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669147|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669148|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669149|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669150|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669151|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669152|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669153|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669154|NCT02062502|O2|Outcome|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669155|NCT02062502|O1|Outcome|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669156|NCT02062502|E2|Reported Event|VARIVAX™ 2007 Process + M-M-R II™|VARIVAX™ 2007 Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669157|NCT02062502|E1|Reported Event|VARIVAX™ New Seed Process + M-M-R II™|VARIVAX™ New Seed Process 0.5 mL administered in the left arm and M-M-R II™ vaccine 0.5 mL administered in the right arm by subcutaneous injection on Day 1 and Day 91.
669158|NCT02062450|B3|Baseline|Total|Total of all reporting groups
669159|NCT02062450|B2|Baseline|Revision Surgery|Patients who underwent a revision hip replacement surgery with Dual Mobility Cup
701289|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
669160|NCT02062450|B1|Baseline|Primary Surgery|Patients who underwent a primary hip replacement surgery with Dual Mobility Cup
669377|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669161|NCT02062450|P1|Participant Flow|Hip Acetabular Replacement, Using a Dual Mobility Cup.|"Studied cohort includes 2 subgroups :~Patients with primary hip replacement.~Patients with revision surgery."
669162|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
669163|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
669164|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
669165|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
669166|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
669167|NCT02062450|O2|Outcome|Revision Sub-group|patients who undergone a revision hip replacement surgery
669168|NCT02062450|O1|Outcome|Primary Surgery Sub-group|Patients who undergone a primary hip replacement surgery
669169|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
669170|NCT02062450|O1|Outcome|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
669171|NCT02062450|E3|Reported Event|Revision Surgery Sub-group|Patients who underwent a Revision Hip Replacement surgery
669172|NCT02062450|E2|Reported Event|Primary Surgery Sub-group|Patients who underwent a Primary Hip Replacement surgery
669173|NCT02062450|E1|Reported Event|Total Safety Population|All patients implanted between Sept 2010 and Dec 2011 who were reached by phone and could answer to the safety questions.
669174|NCT02062437|B1|Baseline|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669175|NCT02062437|P1|Participant Flow|Total Hip Replacement Using a Ceramic Friction Pair|All patients were treated with a total hip replacement using a ceramic friction pair Biolox® delta, with a Meije Duo® cementless stem with HAP associated with a cementless double coating of plasma sprayed titanium and HAP Dynacup® acetabular cup.
669176|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669177|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669178|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669179|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669180|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669181|NCT02062437|O1|Outcome|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669182|NCT02062437|E1|Reported Event|Total Hip Replacement Using a Ceramic Friction Pair|Patients treated with total hip replacement using a ceramic friction pair Biolox® Delta, with Meije Duo® stem associated with Dynacup® cup
669183|NCT02062385|B5|Baseline|Total|Total of all reporting groups
669184|NCT02062385|B4|Baseline|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669185|NCT02062385|B3|Baseline|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669186|NCT02062385|B2|Baseline|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
669187|NCT02062385|B1|Baseline|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
669188|NCT02062385|P4|Participant Flow|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669189|NCT02062385|P3|Participant Flow|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669190|NCT02062385|P2|Participant Flow|Placebo With Staggered EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
669191|NCT02062385|P1|Participant Flow|V260 With Staggered EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered China Expanded Program on Immunization (EPI) as follows: Oral poliovirus vaccine (OPV) administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and diphtheria, tetanus, acellular pertussis vaccine (DTaP) administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months.
669218|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
701290|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
669378|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669192|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669193|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669194|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669195|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669196|NCT02062385|O2|Outcome|Placebo With Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669197|NCT02062385|O1|Outcome|V260 With Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669198|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669199|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669200|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669201|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669202|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669203|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669204|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669205|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669206|NCT02062385|O2|Outcome|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669207|NCT02062385|O1|Outcome|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
701291|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
669208|NCT02062385|E2|Reported Event|Placebo With Staggered or Concomitant EPI|Placebo administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669209|NCT02062385|E1|Reported Event|V260 With Staggered or Concomitant EPI|V260 administered as a 2 mL oral solution at age ~2, 3, and 4 months, and staggered EPI as follows: OPV administered as a 1 g oral solution at age ~2.5, 3.5, and 4.5 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3.5, 4.5, and 5.5 months OR concomitant EPI as follows: OPV administered as a 1 g oral solution at age ~2, 3, and 4 months, and DTaP administered as a 0.5 mL intramuscular injection at age ~3, 4, and 5 months.
669210|NCT02062359|B1|Baseline|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
669211|NCT02062359|P1|Participant Flow|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
669212|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
669213|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
669214|NCT02062359|O1|Outcome|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
669215|NCT02062359|E1|Reported Event|All Participants|"Patients will receive the standard NCI Surgery Branch non-myeloablative, lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by IV infusion of the anti-NY ESO-1 TCR CD62L+ engineered PBL and aldesleukin Anti-NY ESO-1 TCR CD62L+ cells: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 TCR CD62L+ cells and high dose aldesleukin.~On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.~Aldesleukin: Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).~Cyclophosphamide: On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: On days"
669216|NCT02062294|B1|Baseline|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
669217|NCT02062294|P1|Participant Flow|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
669369|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669219|NCT02062294|O1|Outcome|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
669220|NCT02062294|E1|Reported Event|Valganciclovir|Each participant who received 900 mg Valganciclovir for at least 70 days beginning within 10 days post transplantation was observed.
669221|NCT02062177|B3|Baseline|Total|Total of all reporting groups
669222|NCT02062177|B2|Baseline|Midazolam Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
669223|NCT02062177|B1|Baseline|Propofol Group|"70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control.~Patients in this group received placebo boluses with normal saline to warrant blindness to the randomization group of both patient and endoscopist. (because of the well-known difference in the physical appearance of the study drugs, to maintain blindness of endoscopist, a fabric curtain was drawn across patient’s arm covering the i.v. line and TCI pump)."
669224|NCT02062177|P2|Participant Flow|Midazolam Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with midazolam (0.04 mg/kg if aged <70 years - 0.03 mg/kg if aged >70 years).~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
669225|NCT02062177|P1|Participant Flow|Propofol Group|"A total amount of 70 patients (35 undergoing upper endoscopy + 35 undergoing colonoscopy) were sedated with propofol TCI (Target Controlled Infusion) pump. Target concentration was initially set at 1.2-1.6 µg/ml according to patient’s body weight and general condition.~35 patients of the group undergoing colonoscopy received also iv fentanyl (1μg/Kg) for pain control."
669226|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
669227|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
669228|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
669229|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
669230|NCT02062177|O2|Outcome|Midazolam Group; n=35, 35|
669231|NCT02062177|O1|Outcome|Propofol Group; n=35, 35|
669232|NCT02062177|E2|Reported Event|Midazolam Group; n=35, 35|35 upper endoscopy 35 colonoscopy
669233|NCT02062177|E1|Reported Event|Propofol Group; n=35, 35|35 upper endoscopy 35 colonoscopy
669234|NCT02061748|B3|Baseline|Total|Total of all reporting groups
669235|NCT02061748|B2|Baseline|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669236|NCT02061748|B1|Baseline|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669237|NCT02061748|P2|Participant Flow|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669238|NCT02061748|P1|Participant Flow|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669239|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669240|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669241|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669242|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669243|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669244|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669245|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669246|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669247|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669248|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669249|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669250|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669251|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669313|NCT02061683|E1|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
669252|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669253|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669254|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669255|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669256|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669257|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669258|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669259|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669260|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669261|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669262|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669263|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669264|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669265|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669266|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669267|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669268|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669269|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669270|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669271|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669272|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669273|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669274|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669275|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669276|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669277|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669278|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669279|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669280|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669281|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669314|NCT02061592|B3|Baseline|Total|Total of all reporting groups
669282|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669283|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669284|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669285|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669286|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669287|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669288|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669289|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669290|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669291|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669292|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669293|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669294|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669295|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669296|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669297|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669298|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669299|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669300|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669301|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669302|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669303|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669304|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669305|NCT02061748|O2|Outcome|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669306|NCT02061748|O1|Outcome|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669307|NCT02061748|E2|Reported Event|Warfarin|Patients with ≥1 pharmacy claim for warfarin between October 1, 2010 and April 30, 2013 were identified as warfarin users. Patients received 1 to 10 mg tablets, administered orally.
669308|NCT02061748|E1|Reported Event|Dabigatran|Patients with ≥1 pharmacy claim for dabigatran between October 1, 2010 and April 30, 2013 were identified as dabigatran users. Patients received 75 or 150 milligram (mg) dabigatran capsules orally, twice daily.
669309|NCT02061683|B1|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
669310|NCT02061683|P1|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
669311|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
669312|NCT02061683|O1|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
669370|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669315|NCT02061592|B2|Baseline|Test/Control|Subjects first received the test lens, etafilcon A , for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
669316|NCT02061592|B1|Baseline|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
669317|NCT02061592|P2|Participant Flow|Test/Control|Subjects first received the test lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. Subjects then returned for follow-up and were immediately dispensed the control lens, etafilcon A
669318|NCT02061592|P1|Participant Flow|Control/Test|Subjects first received the control lens, etafilcon A for 1 week which was to be worn for a minimum of 8 hours per day. After 1 week subjects returned for follow-up and were immediately dispensed the test lens, etafilcon A.
669319|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A , in either the first week or last week of the study.
669320|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
669321|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
669322|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
669323|NCT02061592|O2|Outcome|Test|Subjects who received Test lens, etafilcon A, in either the first week or last week of the study.
669324|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
669325|NCT02061592|O2|Outcome|Test|Subjects who received the Test lens, etafilcon A, in either the first week or last week of the study.
669326|NCT02061592|O1|Outcome|Control|Subjects who received Control lens, etafilcon A, in either the first week or last week of the study.
669327|NCT02061592|E2|Reported Event|Test|Subjects who received the test lens, etafilcon A, in either the first week or the last week of the study.
669328|NCT02061592|E1|Reported Event|Control|Subjects who received control lens etafilcon A in either the first or the last week of the study .
669329|NCT02061540|B1|Baseline|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669330|NCT02061540|P1|Participant Flow|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669331|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669332|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669333|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669334|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669335|NCT02061540|O1|Outcome|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669336|NCT02061540|O5|Outcome|Maralixibat (LUM001) 10 mg|Participants received LUM001 tablet orally once daily at a dose of 10 mg during Week 6 of the treatment period followed by stable dosing of 10 mg for 8 weeks.
669337|NCT02061540|O4|Outcome|Maralixibat (LUM001) 7.5 mg|Participants received LUM001 tablet orally once daily at a dose of 7.5 mg during Week 5 of the treatment period.
669338|NCT02061540|O3|Outcome|Maralixibat (LUM001) 5 mg|Participants received LUM001 tablet orally once daily at a dose of 5 mg during Week 4 of the treatment period.
669339|NCT02061540|O2|Outcome|Maralixibat (LUM001) 2.5 mg|Participants received LUM001 tablet orally once daily at a dose of 2.5 mg during Week 3 of the treatment period.
669340|NCT02061540|O1|Outcome|Maralixibat (LUM001) 1 mg|Participants received LUM001 tablet orally once daily at a dose of 1 mg during Week 2 of the treatment period.
669341|NCT02061540|E1|Reported Event|Maralixibat (LUM001)|Participants received LUM001 tablet orally once daily at a dose of 0.5 milligram (mg) during Week 1; 1 mg during Week 2; 2.5 mg during Week 3; 5 mg during Week 4; 7.5 mg during Week 5; 10 mg during Week 6 followed by stable dosing of 10 mg for 8 weeks.
669342|NCT02061358|B10|Baseline|Total|Total of all reporting groups
669343|NCT02061358|B9|Baseline|Placebo|Placebo oral, single dose
669344|NCT02061358|B8|Baseline|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669345|NCT02061358|B7|Baseline|720 mg UV-4B|UV-4B 720 mg oral, single dose
669346|NCT02061358|B6|Baseline|360 mg UV-4B|UV-4B 360 mg oral, single dose
669347|NCT02061358|B5|Baseline|180 mg UV-4B|UV-4B 180 mg oral, single dose
669348|NCT02061358|B4|Baseline|90 mg UV-4B|UV-4B 90 mg oral, single dose
669349|NCT02061358|B3|Baseline|30 mg UV-4B|UV-4B 30 mg oral, single dose
669350|NCT02061358|B2|Baseline|10 mg UV-4B|UV-4B 10 mg oral, single dose
669351|NCT02061358|B1|Baseline|3 mg UV-4B|UV-4B 3 mg oral, single dose
669352|NCT02061358|P9|Participant Flow|Placebo|Placebo oral, single dose
669353|NCT02061358|P8|Participant Flow|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669354|NCT02061358|P7|Participant Flow|720 mg UV-4B|UV-4B 720 mg oral, single dose
669355|NCT02061358|P6|Participant Flow|360 mg UV-4B|UV-4B 360 mg oral, single dose
669356|NCT02061358|P5|Participant Flow|180 mg UV-4B|UV-4B 180 mg oral, single dose
669393|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669394|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669395|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669396|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669397|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669398|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669399|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669400|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669401|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669402|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669403|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669404|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669405|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669406|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669407|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669408|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669409|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669410|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669411|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669412|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669413|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669414|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669415|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669416|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669417|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669418|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669419|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669420|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669421|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669422|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669423|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669424|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669425|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669426|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669427|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669428|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669429|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669430|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669431|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669432|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669433|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669434|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669435|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669436|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669437|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669438|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669439|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669440|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669441|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
669442|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669443|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669444|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669445|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669446|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669447|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669448|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669449|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669450|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
669451|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669452|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669453|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669454|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669455|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669456|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669457|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669460|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669461|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669462|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669463|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669464|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669465|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669466|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669467|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669468|NCT02061358|O9|Outcome|Placebo|Placebo oral, single dose
669469|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669470|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669471|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669472|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669473|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669474|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669475|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669478|NCT02061358|O8|Outcome|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669479|NCT02061358|O7|Outcome|720 mg UV-4B|UV-4B 720 mg oral, single dose
669480|NCT02061358|O6|Outcome|360 mg UV-4B|UV-4B 360 mg oral, single dose
669481|NCT02061358|O5|Outcome|180 mg UV-4B|UV-4B 180 mg oral, single dose
669482|NCT02061358|O4|Outcome|90 mg UV-4B|UV-4B 90 mg oral, single dose
669483|NCT02061358|O3|Outcome|30 mg UV-4B|UV-4B 30 mg oral, single dose
669484|NCT02061358|O2|Outcome|10 mg UV-4B|UV-4B 10 mg oral, single dose
669485|NCT02061358|O1|Outcome|3 mg UV-4B|UV-4B 3 mg oral, single dose
669486|NCT02061358|E9|Reported Event|Placebo|Placebo oral, single dose
669487|NCT02061358|E8|Reported Event|1000 mg UV-4B|UV-4B 1000 mg oral, single dose
669488|NCT02061358|E7|Reported Event|720 mg UV-4B|UV-4B 720 mg oral, single dose
669489|NCT02061358|E6|Reported Event|360 mg UV-4B|UV-4B 360 mg oral, single dose
669490|NCT02061358|E5|Reported Event|180 mg UV-4B|UV-4B 180 mg oral, single dose
669491|NCT02061358|E4|Reported Event|90 mg UV-4B|UV-4B 90 mg oral, single dose
669492|NCT02061358|E3|Reported Event|30 mg UV-4B|UV-4B 30 mg oral, single dose
669493|NCT02061358|E2|Reported Event|10 mg UV-4B|UV-4B 10 mg oral, single dose
669494|NCT02061358|E1|Reported Event|3 mg UV-4B|UV-4B 3 mg oral, single dose
669495|NCT02060838|B3|Baseline|Total|Total of all reporting groups
669496|NCT02060838|B2|Baseline|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669497|NCT02060838|B1|Baseline|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669498|NCT02060838|P2|Participant Flow|ANH Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669499|NCT02060838|P1|Participant Flow|ANH Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669500|NCT02060838|O2|Outcome|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669501|NCT02060838|O1|Outcome|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669502|NCT02060838|O2|Outcome|ANH Blood Collected in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669503|NCT02060838|O1|Outcome|ANH Blood Collected in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669504|NCT02060838|E2|Reported Event|ANH Blood Collected & Stored in a Syringe|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in a syringe, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669550|NCT02060539|E1|Reported Event|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669551|NCT02060526|B4|Baseline|Total|Total of all reporting groups
670208|NCT02054910|O2|Outcome|Sham|"A celiac plexus block will not be administered for pain management~Sham"
669505|NCT02060838|E1|Reported Event|ANH Blood Collected & Stored in a Bag|"Patients undergoing acute normovolemic hemodilution (ANH) as part of their cardiac surgery.~Acute normovolemic hemodilution (ANH): Blood is drawn from our patients pre-bypass after obtaining the arterial line, stored in an IV infusion bag, and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine."
669506|NCT02060539|B1|Baseline|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669507|NCT02060539|P1|Participant Flow|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669508|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669509|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669510|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669511|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669512|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
707923|NCT01806857|O2|Outcome|Matching Placebo|
669513|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669514|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669515|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669516|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669517|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669518|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669519|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669520|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669521|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669522|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669523|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669524|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669525|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669526|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669527|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669528|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669529|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669530|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669531|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669532|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669533|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669534|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669535|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669536|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669537|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669538|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669539|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669540|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669541|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669542|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669543|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669544|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669545|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669546|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669547|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669548|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
669549|NCT02060539|O1|Outcome|Comfilcon A|"Participants dispensed Biofinity XR lenses over two weeks of lens wear~Biofinity XR / comfilcon A"
702464|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
669552|NCT02060526|B3|Baseline|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669553|NCT02060526|B2|Baseline|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669554|NCT02060526|B1|Baseline|No HGT-1410|Participants received no treatment (HGT-1410).
669555|NCT02060526|P3|Participant Flow|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally once every four weeks (Q4W) using surgically implanted IDDD or LP for 48 weeks.
669556|NCT02060526|P2|Participant Flow|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 milligram (mg) intrathecally once every two weeks (Q2W) using surgically implanted intrathecal drug delivery device (IDDD) or lumbar puncture (LP) for 48 weeks.
669557|NCT02060526|P1|Participant Flow|No HGT-1410|Participants received no treatment (HGT-1410).
669558|NCT02060526|O2|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669559|NCT02060526|O1|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669560|NCT02060526|O2|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669561|NCT02060526|O1|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669562|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669563|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669564|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669565|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669566|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669567|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669568|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669569|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669570|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669571|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669572|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669573|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669574|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669575|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669576|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669577|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669578|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669579|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669580|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669581|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669582|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669583|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669584|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669585|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669586|NCT02060526|O3|Outcome|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669587|NCT02060526|O2|Outcome|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669588|NCT02060526|O1|Outcome|No HGT-1410|Participants received no treatment (HGT-1410).
669589|NCT02060526|E3|Reported Event|HGT-1410 45 mg Q4W|Participants received HGT-1410 45 mg intrathecally Q4W using surgically implanted IDDD or LP for 48 weeks.
669590|NCT02060526|E2|Reported Event|HGT-1410 45 mg Q2W|Participants received HGT-1410 45 mg intrathecally Q2W using surgically implanted IDDD or LP for 48 weeks.
669591|NCT02060526|E1|Reported Event|No HGT-1410|Participants received no treatment (HGT-1410).
669592|NCT02059993|B3|Baseline|Total|Total of all reporting groups
669593|NCT02059993|B2|Baseline|Control|The control group received the standardized antihypertensive medications but without receiving CPAP machine.
669594|NCT02059993|B1|Baseline|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
669595|NCT02059993|P2|Participant Flow|Control|The controls only received the cardiovascular drugs based on the guidelines but without continuous positive airway pressure machine.
669596|NCT02059993|P1|Participant Flow|Continuous Positive Airway Pressure(CPAP) Group|The continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure and the the cardiovascular drugs based on the guidelines.
669597|NCT02059993|O2|Outcome|Control|The patients who use standardized drugs without CPAP machine.
669598|NCT02059993|O1|Outcome|Continuous Positive Airway Pressure(CPAP) Group|The subjects who received CPAP treatment and standardized medicine.
669599|NCT02059993|E2|Reported Event|Control|The control subjects received standardised anti-hypertension medications according to the current guildline.
669600|NCT02059993|E1|Reported Event|Continuous Positive Airway Pressure(CPAP) Group|The CPAP group received fixed-level CPAP titration using an automated pressure setting device for 1 night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night.
669601|NCT02059928|B1|Baseline|Intraosseous Device Placement|"Intraosseous device~Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients"
669602|NCT02059928|P1|Participant Flow|Intraosseous Device Placement|"Intraosseous device~Intraosseous Device pressure measurement"
669603|NCT02059928|O1|Outcome|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
669604|NCT02059928|E1|Reported Event|Intraosseous Device Placement|Intraosseous Pressure Monitoring in Surgical Intensive Care Unit Patients
669605|NCT02059902|B3|Baseline|Total|Total of all reporting groups
670119|NCT02056392|P4|Participant Flow|Selumetinib Placebo/Moxifloxacin/Selumetinib|
669606|NCT02059902|B2|Baseline|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
669607|NCT02059902|B1|Baseline|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
669608|NCT02059902|P2|Participant Flow|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
669609|NCT02059902|P1|Participant Flow|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
669610|NCT02059902|O2|Outcome|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
669611|NCT02059902|O1|Outcome|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
669612|NCT02059902|E2|Reported Event|Lidocaine|"Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)~Lidocaine: Lidocaine infusion runs for a total of 24 hours"
669613|NCT02059902|E1|Reported Event|Normal Pain Management|"Normal saline (bolus followed by continuous infusion)~Placebo: Normal saline runs for a total of 24 hours"
669614|NCT02059642|B3|Baseline|Total|Total of all reporting groups
669615|NCT02059642|B2|Baseline|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
669616|NCT02059642|B1|Baseline|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
669617|NCT02059642|P2|Participant Flow|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
669618|NCT02059642|P1|Participant Flow|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
669619|NCT02059642|O2|Outcome|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
669620|NCT02059642|O1|Outcome|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
669621|NCT02059642|O2|Outcome|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
669622|NCT02059642|O1|Outcome|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
669623|NCT02059642|E2|Reported Event|MG01CI (1400 mg)|"MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) Dose, route, and frequency: 1400 mg administered orally once daily~MG01CI (1400 mg): MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily"
669624|NCT02059642|E1|Reported Event|Placebo|"Placebo tablet identical in appearance to study investigational product Route, frequency: Administered orally once daily~placebo: Placebo 1400 mg administered orally once daily"
669625|NCT02059291|B7|Baseline|Total|Total of all reporting groups
669626|NCT02059291|B6|Baseline|TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669627|NCT02059291|B5|Baseline|TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
669682|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669803|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669628|NCT02059291|B4|Baseline|HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669629|NCT02059291|B3|Baseline|HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
669688|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669630|NCT02059291|B2|Baseline|crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg."
669631|NCT02059291|B1|Baseline|crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
669632|NCT02059291|P6|Participant Flow|TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669633|NCT02059291|P5|Participant Flow|TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
669634|NCT02059291|P4|Participant Flow|HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669635|NCT02059291|P3|Participant Flow|HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
669636|NCT02059291|P2|Participant Flow|crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg."
669637|NCT02059291|P1|Participant Flow|crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
669638|NCT02059291|O6|Outcome|TRAPS: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between Day 8 and 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669639|NCT02059291|O5|Outcome|TRAPS: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration
669640|NCT02059291|O4|Outcome|HIDS/MKD: Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28 and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669641|NCT02059291|O3|Outcome|HIDS/MKD: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
669642|NCT02059291|O2|Outcome|crCMF: Placebo|"During epoch 2, participants received matching placebo to canakinumab 150 mg Participants who required blinded escape,they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded one dose of placebo and one dose of canakinumab q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab.~150mg, participants were uptitrated to open-label canakinumab 300 mg."
707924|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
669643|NCT02059291|O1|Outcome|crFMF: 150 mg|During Epoch 2, participants received canakinumab 150mg (or 2mg/kg for participants weighing <= 40kg) q4w for 16 weeks. If participants were eligible for blinded escape, they received a single add-on dose of canakinumab (150 mg or 2mg/kg for participants weighing <= 40kg) between day 8 and day 28, and then received blinded uptitration to canakinumab 300 mg q4w from day 29 through day 112. If patients on the highest allowed canakinumab dose of 300 mg (or 4 mg/kg for patients weighing ≤ 40 kg) q4w and re-flared (PGA ≥ 2 and CRP ≥ 30 mg/L) were not eligible for further up-titration.
669644|NCT02059291|E6|Reported Event|crFMF Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape prior to day 29, received 1 dose of canakinumab 150 mg and 1 dose of placebo q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669645|NCT02059291|E5|Reported Event|crFMF 150 mg + crFMF Placebo Switched to 150 mg|crFMF 150 mg plus crFMF placebo non responders switched to 150 mg
669646|NCT02059291|E4|Reported Event|HIDS Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape prior to day 29, received 1 dose of canakinumab 150 mg and 1 dose of placebo q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669647|NCT02059291|E3|Reported Event|HIDS/MKD 150 mg + HIDS/MKD Placebo Switched to 150 mg|HIDS/MKD 150 mg plus HIDS/MKD non responders switched to 150 mg
669648|NCT02059291|E2|Reported Event|TRAPS Placebo|During epoch 2, participants received matching placebo to canakinumab 150 mg qw4. Participants who required blinded escape prior to day 29, received 1 dose of canakinumab 150 mg and 1 dose of placebo q4w from day 29 through day 112. If flare or re-flare still occurred after receipt of canakinumab 150mg, participants were uptitrated to open-label canakinumab 300 mg.
669649|NCT02059291|E1|Reported Event|TRAPS 150 mg + TRAPS Placebo Switched to 150mg|TRAPS 150mg plus TRAPS placebo non responders switched to 150 mg
669650|NCT02059187|B3|Baseline|Total|Total of all reporting groups
669651|NCT02059187|B2|Baseline|Lantus™|Lantus™ administered subcutaneously once daily.
669652|NCT02059187|B1|Baseline|MK-1293|MK-1293 administered subcutaneously once daily.
669653|NCT02059187|P2|Participant Flow|Lantus™|Lantus™ administered subcutaneously once daily.
669654|NCT02059187|P1|Participant Flow|MK-1293|MK-1293 administered subcutaneously once daily.
669655|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669656|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669657|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669658|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669659|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669660|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669661|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669662|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669663|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669664|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669665|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669666|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669667|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669668|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669669|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669670|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669671|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669672|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669673|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669674|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669675|NCT02059187|O2|Outcome|Lantus™|Lantus™ administered subcutaneously once daily.
669676|NCT02059187|O1|Outcome|MK-1293|MK-1293 administered subcutaneously once daily.
669677|NCT02059187|E2|Reported Event|Lantus™|Lantus™ administered subcutaneously once daily.
669678|NCT02059187|E1|Reported Event|MK-1293|MK-1293 administered subcutaneously once daily.
669679|NCT02059174|B1|Baseline|All Participants|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669680|NCT02059174|P2|Participant Flow|EU-Lantus™ / MK-1293 / EU-Lantus™ / MK-1293|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669681|NCT02059174|P1|Participant Flow|MK-1293 / EU-Lantus™ / MK-1293 / EU-Lantus™|MK-1293 or EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
702466|NCT01839604|E4|Reported Event|2.5 mg/kg|given intravenously Part A
669683|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669684|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669685|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669686|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669687|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669689|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669690|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669691|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669692|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669693|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669694|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669695|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669696|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669697|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669698|NCT02059174|O2|Outcome|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669699|NCT02059174|O1|Outcome|MK-1293|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between each treatment period
669700|NCT02059174|E2|Reported Event|EU-Lantus™ 0.4 Units.kg SC|EU-Lantus™ 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
669701|NCT02059174|E1|Reported Event|MK-1293 0.4 Units/kg SC|MK-1293 0.4 units/kg administered subcutaneously on Day 1 in 2 out of 4 study periods in a replicate crossover design with a minimum of 7 days between treatment periods
669702|NCT02059161|B3|Baseline|Total|Total of all reporting groups
669703|NCT02059161|B2|Baseline|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669704|NCT02059161|B1|Baseline|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669705|NCT02059161|P2|Participant Flow|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669706|NCT02059161|P1|Participant Flow|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669707|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669708|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669709|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669710|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669711|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669712|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669802|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669713|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669714|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669715|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669716|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669717|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669718|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669719|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669720|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669721|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669722|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669723|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669724|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669725|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669726|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669727|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669728|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669729|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669730|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669731|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669732|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669733|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669734|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669735|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669736|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669737|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669738|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
670837|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
669739|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669740|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669741|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669742|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669743|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669744|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669745|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669746|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669747|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669748|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669749|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669750|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669751|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669752|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669753|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669754|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669755|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669756|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669757|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669758|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669759|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669760|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669761|NCT02059161|O2|Outcome|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669762|NCT02059161|O1|Outcome|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669763|NCT02059161|E2|Reported Event|Lantus|Lantus dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669764|NCT02059161|E1|Reported Event|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Doses were individually titrated post-randomization to the suggested target for fasting fingerstick glucose levels of >70 mg/dL (3.9 mmol/L) and ≤100 mg/dL (5.6 mmol/L).
669765|NCT02059070|B3|Baseline|Total|Total of all reporting groups
669766|NCT02059070|B2|Baseline|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669767|NCT02059070|B1|Baseline|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669768|NCT02059070|P2|Participant Flow|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669769|NCT02059070|P1|Participant Flow|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669770|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669771|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669772|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669773|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669774|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669775|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669776|NCT02059070|O2|Outcome|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669777|NCT02059070|O1|Outcome|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669778|NCT02059070|E2|Reported Event|0.2% Ropivacaine|"Group 2) Post-operative 0.125% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Ropivacaine: Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669779|NCT02059070|E1|Reported Event|0.125% Bupivacaine|"Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.~Bupivacaine: Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery."
669780|NCT02058992|B1|Baseline|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669781|NCT02058992|P1|Participant Flow|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669782|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669783|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669784|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669785|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669786|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669787|NCT02058992|O1|Outcome|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669788|NCT02058992|E1|Reported Event|Ramelteon|Ramelteon 8 mg, tablets, orally, once as daily clinical practice were observed for up to 4 weeks. A follow up of 2 weeks was carried out.
669789|NCT02058563|B3|Baseline|Total|Total of all reporting groups
669790|NCT02058563|B2|Baseline|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669791|NCT02058563|B1|Baseline|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669792|NCT02058563|P2|Participant Flow|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II ) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669793|NCT02058563|P1|Participant Flow|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669794|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669795|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669796|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669797|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669798|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669799|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669800|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669801|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669804|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669805|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669806|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669807|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669808|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669809|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669810|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669811|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669812|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669813|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669814|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669815|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669816|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669817|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669818|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669819|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669820|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669821|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669822|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669823|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669824|NCT02058563|O2|Outcome|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669825|NCT02058563|O1|Outcome|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669826|NCT02058563|E2|Reported Event|COM_MMR Group|Subjects received one dose of COM_MMR (M-M-R®II) vaccine from Lot 1 or Lot 2 at Visit 1 (Day 0).
669827|NCT02058563|E1|Reported Event|INV_MMR Group|Subjects received one dose of INV_MMR (Priorix®) vaccine at Visit 1 (Day 0).
669828|NCT02058537|B1|Baseline|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
669829|NCT02058537|P1|Participant Flow|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
669830|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
669831|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
669832|NCT02058537|O1|Outcome|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
669833|NCT02058537|E1|Reported Event|Bethanechol|"Oral administration of 25 milligrams of bethanechol taken twice daily for a minimum of 7 days. Total dose taken daily for a minimum of 7 days is 50 mg.~Bethanechol: Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover."
669834|NCT02058498|B1|Baseline|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
669835|NCT02058498|P1|Participant Flow|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
669836|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
669887|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
702467|NCT01839604|E3|Reported Event|2 mg/kg|given intravenously Part A
669837|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
669838|NCT02058498|O1|Outcome|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
669893|NCT02058160|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
669894|NCT02058147|B4|Baseline|Total|Total of all reporting groups
669839|NCT02058498|E1|Reported Event|Liver Transplant Patients|"Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log.~Physical activity: Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months."
669840|NCT02058290|B3|Baseline|Total|Total of all reporting groups
669841|NCT02058290|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669842|NCT02058290|B1|Baseline|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669843|NCT02058290|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669844|NCT02058290|P1|Participant Flow|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669845|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669846|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669847|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669848|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669849|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669850|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669851|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669888|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669889|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669852|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669895|NCT02058147|B3|Baseline|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669896|NCT02058147|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669897|NCT02058147|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669853|NCT02058290|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669854|NCT02058290|O1|Outcome|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669855|NCT02058290|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients received 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac was given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) could be substituted per the site's standard of care.~All patients were offered rescue analgesia, as needed."
669856|NCT02058290|E1|Reported Event|IV Morphine Sulfate or Sponsor-approved Equivalent|"Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients in this group received IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump was set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU was less than one hour."
669857|NCT02058160|B3|Baseline|Total|Total of all reporting groups
669858|NCT02058160|B2|Baseline|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669859|NCT02058160|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669860|NCT02058160|P2|Participant Flow|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669861|NCT02058160|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
669862|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669863|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669864|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669865|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669866|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669867|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669868|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669869|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669870|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669871|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669872|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669873|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669874|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669875|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669876|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669877|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669878|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669879|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669880|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669881|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669882|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669883|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669884|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669885|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669886|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669890|NCT02058160|O2|Outcome|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669891|NCT02058160|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669892|NCT02058160|E2|Reported Event|Insulin Glargine|Insulin glargine 100 U/mL injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 210 days).
669898|NCT02058147|P3|Participant Flow|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669899|NCT02058147|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669900|NCT02058147|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination (FRC)|FRC injected subcutaneously once daily (QD) for 30 weeks. Dose individually adjusted.
669901|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669902|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669903|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669904|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669905|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669906|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669907|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669908|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669909|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669910|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669911|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669912|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669913|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669914|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669915|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669916|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669917|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669918|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669919|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669920|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669921|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669922|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669923|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669924|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669925|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669926|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669927|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669928|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669929|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669930|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669931|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669932|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669933|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669934|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669935|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669936|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669937|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669938|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669939|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669940|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669941|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669942|NCT02058147|O3|Outcome|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose).
669943|NCT02058147|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669944|NCT02058147|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted.
669945|NCT02058147|E3|Reported Event|Lixisenatide|Lixisenatide 10 mcg injected subcutaneously QD for 2 weeks, then 20 mcg QD (maintenance dose) median exposure: 211 days).
669946|NCT02058147|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
669947|NCT02058147|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 30 weeks. Dose individually adjusted (median exposure: 211 days).
669948|NCT02058069|B1|Baseline|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
669949|NCT02058069|P1|Participant Flow|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Participants throughout this posting is equivalent to the number of knees."
669950|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
669951|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
669952|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
669953|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
669954|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
669955|NCT02058069|O1|Outcome|Robotic Assisted Total Knee Arthroplasty|Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.
669956|NCT02058069|E1|Reported Event|Robotic Assisted Total Knee Arthroplasty|"Participants who underwent primary total knee arthroplasty using the Mako robotic arm system.~Note regarding serious AEs:~Adhesions and arthrofibrosis are surgical complications that can result from knee surgery and present as stiffness and restriction of ROM. Reasons for stiffness and restriction of ROM after TKA are multifactorial and may be influenced by factors such as the patient’s overall health, motivation, and compliance to their rehabilitation regimen. The Principal Investigator and study Investigators stated these adverse events are not related to the use of the Investigational Device."
669957|NCT02057835|B11|Baseline|Total|Total of all reporting groups
669958|NCT02057835|B10|Baseline|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669959|NCT02057835|B9|Baseline|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669960|NCT02057835|B8|Baseline|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669961|NCT02057835|B7|Baseline|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669962|NCT02057835|B6|Baseline|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
669963|NCT02057835|B5|Baseline|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669964|NCT02057835|B4|Baseline|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669965|NCT02057835|B3|Baseline|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669966|NCT02057835|B2|Baseline|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669967|NCT02057835|B1|Baseline|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
669968|NCT02057835|P10|Participant Flow|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669969|NCT02057835|P9|Participant Flow|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669970|NCT02057835|P8|Participant Flow|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669971|NCT02057835|P7|Participant Flow|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669972|NCT02057835|P6|Participant Flow|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
669973|NCT02057835|P5|Participant Flow|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669974|NCT02057835|P4|Participant Flow|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669975|NCT02057835|P3|Participant Flow|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669976|NCT02057835|P2|Participant Flow|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669977|NCT02057835|P1|Participant Flow|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
669978|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669979|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669980|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669981|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669982|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669983|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669984|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669985|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669986|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669987|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669988|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669989|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669990|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669991|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669992|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669993|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669994|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669995|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
669996|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
669997|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
669998|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
669999|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670000|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670001|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670002|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670003|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670004|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670005|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670006|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670007|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670008|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670009|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670010|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670107|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670011|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670012|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670013|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670014|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670015|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670016|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670017|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670018|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670019|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670020|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670021|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670022|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670023|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670024|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670025|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670026|NCT02057835|O4|Outcome|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670027|NCT02057835|O3|Outcome|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670028|NCT02057835|O2|Outcome|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670029|NCT02057835|O1|Outcome|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670030|NCT02057835|O8|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670031|NCT02057835|O7|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670032|NCT02057835|O6|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670033|NCT02057835|O5|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670034|NCT02057835|O4|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670035|NCT02057835|O3|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670036|NCT02057835|O2|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670037|NCT02057835|O1|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670038|NCT02057835|O10|Outcome|Japanese: BI 691751 60mg|Japanese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670039|NCT02057835|O9|Outcome|Japanese: BI 691751 30mg|Japanese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670040|NCT02057835|O8|Outcome|Japanese: BI 691751 10mg|Japanese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670041|NCT02057835|O7|Outcome|Japanese: BI 691751 5mg|Japanese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670042|NCT02057835|O6|Outcome|Japanese: Placebo|Japanese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
670043|NCT02057835|O5|Outcome|Chinese: BI 691751 60mg|Chinese participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670044|NCT02057835|O4|Outcome|Chinese: BI 691751 30mg|Chinese participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670045|NCT02057835|O3|Outcome|Chinese: BI 691751 10mg|Chinese participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670046|NCT02057835|O2|Outcome|Chinese: BI 691751 5mg|Chinese participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670047|NCT02057835|O1|Outcome|Chinese: Placebo|Chinese participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
702468|NCT01839604|E2|Reported Event|1.5 mg/kg|given intravenously. Part A
670048|NCT02057835|E5|Reported Event|BI 691751 60mg|Participants received a single tablet of BI 691751 60mg orally with 240 mL water after an overnight fast of at least 10 hours.
670049|NCT02057835|E4|Reported Event|BI 691751 30mg|Participants received a single tablet of BI 691751 30mg orally with 240 mL water after an overnight fast of at least 10 hours.
670050|NCT02057835|E3|Reported Event|BI 691751 10mg|Participants received a single tablet of BI 691751 10mg orally with 240 mL water after an overnight fast of at least 10 hours.
670051|NCT02057835|E2|Reported Event|BI 691751 5mg|Participants received a single tablet of BI 691751 5mg orally with 240 mL water after an overnight fast of at least 10 hours.
670052|NCT02057835|E1|Reported Event|Placebo|Participants received a single placebo tablet matching the BI 691751 tablets, orally with 240 mL water after an overnight fast of at least 10 hours.
670053|NCT02057406|B4|Baseline|Total|Total of all reporting groups
670054|NCT02057406|B3|Baseline|Placebo|"Matched placebo corn oil capsules~Placebo"
670056|NCT02057406|B1|Baseline|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
670057|NCT02057406|P3|Participant Flow|Placebo|"Matched placebo corn oil capsules~Placebo"
670058|NCT02057406|P2|Participant Flow|High EPA|"Almost pure EPA 2 grams~High EPA"
670059|NCT02057406|P1|Participant Flow|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid (DHA) fish oil 2 grams"
670060|NCT02057406|O3|Outcome|Placebo|"Matched placebo corn oil capsules~Placebo"
670061|NCT02057406|O2|Outcome|High EPA|"Almost pure EPA 2 grams~High EPA"
670062|NCT02057406|O1|Outcome|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
670063|NCT02057406|O3|Outcome|Placebo|"Matched placebo corn oil capsules~Placebo"
670064|NCT02057406|O2|Outcome|High EPA|"Almost pure EPA 2 grams~High EPA"
670065|NCT02057406|O1|Outcome|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
670066|NCT02057406|E3|Reported Event|Placebo|"Matched placebo corn oil capsules~Placebo"
670067|NCT02057406|E2|Reported Event|High EPA|"Almost pure EPA 2 grams~High EPA"
670068|NCT02057406|E1|Reported Event|2:1 EPA/DHA|"400/200 EPA/DHA fish oil 2 grams~2:1 EPA/DHA: 400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams"
670069|NCT02057393|B1|Baseline|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
670070|NCT02057393|P1|Participant Flow|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
670071|NCT02057393|O1|Outcome|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
670072|NCT02057393|E1|Reported Event|Indocyanine Green|"Single arm study, each subject receives 0.9ml ICG, methylene blue and technetium 99.~Indocyanine green: Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.~Technetium99: Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.~Methylene blue: Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye."
670073|NCT02057276|B3|Baseline|Total|Total of all reporting groups
670074|NCT02057276|B2|Baseline|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
670075|NCT02057276|B1|Baseline|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
670076|NCT02057276|P2|Participant Flow|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
670108|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
702469|NCT01839604|E1|Reported Event|AZD9150 1mg/kg|Intravenous. Part A.
670077|NCT02057276|P1|Participant Flow|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
670078|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
670079|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
670080|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
670081|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
670082|NCT02057276|O2|Outcome|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
670083|NCT02057276|O1|Outcome|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
670084|NCT02057276|E2|Reported Event|Sham rTMS|"Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Sham Repetitive Transcranial Magnetic Stimulation~Occupational Therapy"
670085|NCT02057276|E1|Reported Event|Active rTMS|"Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.~Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.~Occupational Therapy"
670086|NCT02057237|B1|Baseline|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
670087|NCT02057237|P1|Participant Flow|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
670088|NCT02057237|O1|Outcome|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
670089|NCT02057237|O1|Outcome|Single Arm|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
670090|NCT02057237|E1|Reported Event|Single Arm - Mitotane|"Mitotane will be administered on an outpatient or inpatient basis.~Mitotane: Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily"
670091|NCT02056834|B1|Baseline|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670092|NCT02056834|P1|Participant Flow|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670093|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670094|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670095|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670096|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670097|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670098|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670099|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670100|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670101|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670102|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670103|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670104|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
670105|NCT02056834|O1|Outcome|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
670106|NCT02056834|O1|Outcome|chronOS Inject|Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect
702832|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
670109|NCT02056834|E1|Reported Event|chronOS Inject|"Closed proximal tibial fractures of type Schatzker I - VI, AO-OTA 41, AO-OTA 42 with bone defect~chronOS Inject: chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures"
670110|NCT02056392|B7|Baseline|Total|Total of all reporting groups
670111|NCT02056392|B6|Baseline|Selumetinib/Selumetinib Placebo/Moxifloxacin|
670112|NCT02056392|B5|Baseline|Selumetinib Placebo/Selumetinib/Moxifloxacin|
670113|NCT02056392|B4|Baseline|Selumetinib Placebo/Moxifloxacin/Selumetinib|
670114|NCT02056392|B3|Baseline|Moxifloxacin/Selumetinib Placebo/Selumetinib|
670115|NCT02056392|B2|Baseline|Moxifloxacin/Selumetinib/Selumetinib Placebo|
670116|NCT02056392|B1|Baseline|Selumetinib/Moxifloxacin/Selumetinib Placebo|
670117|NCT02056392|P6|Participant Flow|Selumetinib/Selumetinib Placebo/Moxifloxacin|
670118|NCT02056392|P5|Participant Flow|Selumetinib Placebo/Selumetinib/Moxifloxacin|
670120|NCT02056392|P3|Participant Flow|Moxifloxacin/Selumetinib Placebo/Selumetinib|
670121|NCT02056392|P2|Participant Flow|Moxifloxacin/Selumetinib/Selumetinib Placebo|
670122|NCT02056392|P1|Participant Flow|Selumetinib/Moxifloxacin/Selumetinib Placebo|
670123|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670124|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670125|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670126|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670127|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670128|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670129|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670130|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670131|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670132|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670133|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670134|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670135|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670136|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670137|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670138|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670139|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670140|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670141|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670142|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670143|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670144|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670145|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670146|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670147|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670148|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670149|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670150|NCT02056392|O3|Outcome|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670151|NCT02056392|O2|Outcome|Placebo|Selumetinib placebo (3 capsules)
670152|NCT02056392|O1|Outcome|Moxifloxacin|Moxiflxacin 400 mg (open label)
670153|NCT02056392|E3|Reported Event|Placebo|Selumetinib placebo (3 capsules)
670154|NCT02056392|E2|Reported Event|Moxifloxacin|Moxiflxacin 400 mg (open label)
670155|NCT02056392|E1|Reported Event|Selumetinib|Selumetinib 75mg bs (3x25mg capsules)
670156|NCT02055430|B3|Baseline|Total|Total of all reporting groups
670157|NCT02055430|B2|Baseline|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670158|NCT02055430|B1|Baseline|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670159|NCT02055430|P2|Participant Flow|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670160|NCT02055430|P1|Participant Flow|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670161|NCT02055430|O2|Outcome|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670205|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
670206|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
670207|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
670162|NCT02055430|O1|Outcome|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670163|NCT02055430|E2|Reported Event|Bilateral Double J Ureteric Stents|"double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.~bilateral double J ureteric stent: The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670216|NCT02054754|B1|Baseline|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
670217|NCT02054754|P6|Participant Flow|Placebo|"Single oral dose of matching placebo~Placebo"
707925|NCT01806857|O2|Outcome|Matching Placebo|
670164|NCT02055430|E1|Reported Event|Percutaneous Nephrostomy|"percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.~percutaneous nephrostomy insertion: The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.~Definitive stone management: (shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones."
670165|NCT02055404|B1|Baseline|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
670166|NCT02055404|P1|Participant Flow|Overall Study|Delefilcon A spherical contact lens with molded marks and etafilcon A toric contact lens worn contralaterally (1 in each eye) for approximately 2 hours
670167|NCT02055404|O9|Outcome|Control|Etafilcon A toric contact lens
670168|NCT02055404|O8|Outcome|S8 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670169|NCT02055404|O7|Outcome|S7 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670170|NCT02055404|O6|Outcome|S6 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670171|NCT02055404|O5|Outcome|S5 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670172|NCT02055404|O4|Outcome|S4 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670173|NCT02055404|O3|Outcome|S3 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670174|NCT02055404|O2|Outcome|S2 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670175|NCT02055404|O1|Outcome|S1 Mark|Delefilcon A spherical contact lens with 1 of 9 molded marks
670176|NCT02055404|E2|Reported Event|Etafilcon A|Etafilcon A toric contact lens randomly assigned to one eye, with delefilcon A spherical contact lens with molded marks in the fellow eye for contralateral wear approximately 2 hours in duration
670177|NCT02055404|E1|Reported Event|Delefilcon A|Delefilcon A spherical contact lens with molded marks randomly assigned to one eye, with etafilcon A toric contact lens in the fellow eye for contralateral wear approximately 2 hours in duration.
670178|NCT02055352|B3|Baseline|Total|Total of all reporting groups
670179|NCT02055352|B2|Baseline|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
670180|NCT02055352|B1|Baseline|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
670181|NCT02055352|P2|Participant Flow|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
670182|NCT02055352|P1|Participant Flow|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
670183|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
670184|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
670185|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
670186|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
670187|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
670188|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
670189|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
670190|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
670191|NCT02055352|O2|Outcome|Fluticasone / Salmeterol|Fixed combination of fluticasone and salmeterol
670192|NCT02055352|O1|Outcome|Budesonide/Indacaterol|Participants will receive a fixed combination of fluticasone and salmeterol during 4 weeks followed by a free combination of budesonide and indacaterol for the remainig of study.
670193|NCT02055352|E2|Reported Event|Fluticasone / Salmeterol (B)|Fluticasone / Salmeterol (B)
670194|NCT02055352|E1|Reported Event|Budesonide / Indacaterol (A)|Budesonide / Indacaterol (A)
670195|NCT02054910|B3|Baseline|Total|Total of all reporting groups
670196|NCT02054910|B2|Baseline|Sham|"A celiac plexus block will not be administered for pain management~Sham"
670197|NCT02054910|B1|Baseline|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
670198|NCT02054910|P2|Participant Flow|Sham|"A celiac plexus block will not be administered for pain management~Sham"
670199|NCT02054910|P1|Participant Flow|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
670200|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
670201|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
670202|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
670203|NCT02054910|O1|Outcome|Celiac Plexus Block|Celiac Plexus Block will be administered following EUS
670204|NCT02054910|O2|Outcome|Sham|A celiac plexus block will not be administered for pain management
670209|NCT02054910|O1|Outcome|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
670210|NCT02054910|O2|Outcome|Sham|"A celiac plexus block will not be administered for pain management~Sham"
670211|NCT02054910|O1|Outcome|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
670212|NCT02054910|E2|Reported Event|Sham|"A celiac plexus block will not be administered for pain management~Sham"
670213|NCT02054910|E1|Reported Event|Celiac Plexus Block|"Celiac Plexus Block will be administered following EUS~Celiac Plexus Block"
670214|NCT02054754|B3|Baseline|Total|Total of all reporting groups
670215|NCT02054754|B2|Baseline|Placebo|"Single oral dose of matching placebo~Placebo"
670218|NCT02054754|P5|Participant Flow|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol at Dose level 5~Dexanabinol: Oral formulation of dexanabinol"
670219|NCT02054754|P4|Participant Flow|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol at Dose level 4~Dexanabinol: Oral formulation of dexanabinol"
670220|NCT02054754|P3|Participant Flow|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol at Dose level 3~Dexanabinol: Oral formulation of dexanabinol"
670221|NCT02054754|P2|Participant Flow|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol at Dose level 2~Dexanabinol: Oral formulation of dexanabinol"
670222|NCT02054754|P1|Participant Flow|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol at Dose Level 1~Dexanabinol: Oral formulation of dexanabinol"
670223|NCT02054754|O5|Outcome|Dose Level 5|
670224|NCT02054754|O4|Outcome|Dose Level 4|
670225|NCT02054754|O3|Outcome|Dose Level 3|
670226|NCT02054754|O2|Outcome|Dose Level 2|
670227|NCT02054754|O1|Outcome|Dexanabinol Dose Level 1|
670228|NCT02054754|O2|Outcome|Placebo|"Single oral dose of matching placebo~Placebo"
670229|NCT02054754|O1|Outcome|Dexanabinol|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
670230|NCT02054754|E6|Reported Event|Placebo|"Single oral dose of matching placebo~Placebo"
670231|NCT02054754|E5|Reported Event|Dexanabinol Dose Level 5|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
670232|NCT02054754|E4|Reported Event|Dexanabinol Dose Level 4|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
670233|NCT02054754|E3|Reported Event|Dexanabinol Dose Level 3|"Single oral dose of dexanabinol~Dexanabinol: Oral formuulation of dexanabinol"
670234|NCT02054754|E2|Reported Event|Dexanabinol Dose Level 2|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
670235|NCT02054754|E1|Reported Event|Dexanabinol Dose Level 1|"Single oral dose of dexanabinol~Dexanabinol: Oral formulation of dexanabinol"
670236|NCT02054702|B3|Baseline|Total|Total of all reporting groups
670237|NCT02054702|B2|Baseline|Arpiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670238|NCT02054702|B1|Baseline|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670239|NCT02054702|P2|Participant Flow|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670240|NCT02054702|P1|Participant Flow|Brexpiprazole|Participants were administered brexpiprazole tablets orally, once daily (QD) starting dose at 1 milligram per day (mg/day) for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670241|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670242|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670243|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670244|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670245|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670246|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670247|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670248|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670249|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670250|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670251|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670252|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670253|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670254|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670255|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670729|NCT02048072|P1|Participant Flow|Gilenya|Gilenya 0.5mg p.o. once daily
670256|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670257|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670258|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670259|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670260|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670261|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670262|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670263|NCT02054702|O2|Outcome|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670264|NCT02054702|O1|Outcome|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670265|NCT02054702|E2|Reported Event|Aripiprazole|Participants were administered aripiprazole tablets orally QD, starting dose at 10 mg/day for 1 week, followed by 15 mg/day at the Week 1 visit and 10, 15, or 20 mg/day from week 2 to week 6.
670266|NCT02054702|E1|Reported Event|Brexpiprazole|Participants were administered brexpiprazole tablets orally QD, starting dose at 1 mg/day for 4 days followed by 2 mg/day for 3 days and 3 mg/day at the week 1 visit and 1, 2, 3, or 4 mg/day from week 2 to week 6.
670267|NCT02054572|B1|Baseline|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670268|NCT02054572|P1|Participant Flow|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670269|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670270|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670271|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670272|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670273|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670274|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670275|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670276|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670277|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670278|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670279|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670280|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670281|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670282|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670283|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670284|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670285|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670286|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670730|NCT02048072|O1|Outcome|Gilenya|Gilenya 0.5mg p.o. once daily
670287|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670288|NCT02054572|O1|Outcome|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by intravenous (IV) bolus injection at the end of hemodialysis on day 1.
670289|NCT02054572|E1|Reported Event|[¹⁴C]Etelcalcetide|Participants received a single dose of 10 mg radiolabelled etelcalcetide administered by IV bolus at the end of hemodialysis on day 1.
670290|NCT02054481|B5|Baseline|Total|Total of all reporting groups
670291|NCT02054481|B4|Baseline|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670292|NCT02054481|B3|Baseline|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670293|NCT02054481|B2|Baseline|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670294|NCT02054481|B1|Baseline|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670295|NCT02054481|P4|Participant Flow|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670296|NCT02054481|P3|Participant Flow|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670297|NCT02054481|P2|Participant Flow|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670298|NCT02054481|P1|Participant Flow|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670299|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670300|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670301|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670302|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670303|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670304|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670305|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670306|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670307|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670308|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670309|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670310|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670311|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670312|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670313|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670314|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670315|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670731|NCT02048072|E1|Reported Event|Gilenya|Gilenya 0.5mg p.o. once daily
670316|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670317|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670318|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670319|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670320|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670321|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670322|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670323|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670324|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670325|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670326|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670327|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670328|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670329|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670330|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670331|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670332|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670333|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670334|NCT02054481|O5|Outcome|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670335|NCT02054481|O4|Outcome|BI 655066 90+180 mg|90 mg BI 655066 or 180mg BI 655066 administered by subcutaneous injection at Weeks 0, 4 and 16, plus matching placebos.
670336|NCT02054481|O3|Outcome|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670337|NCT02054481|O2|Outcome|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670338|NCT02054481|O1|Outcome|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670339|NCT02054481|E4|Reported Event|Stelara|Stelara administered by subcutaneous injection plus two saline injections at Week 0, Stelara injection plus one saline injection at Weeks 4 and 16. Stelara dose was 45 mg for patients with body weight ≤100 kg at randomisation or 90 mg for patients with body weight >100 kg at randomisation.
670340|NCT02054481|E3|Reported Event|BI 655066 180 mg|180 mg BI 655066 administered by subcutaneous injection as two injections plus a placebo matching BI 655066 injection at Week 0, followed 180 mg BI 655066 administered as two injections at Weeks 4 and 16.
670721|NCT02048891|B1|Baseline|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
670341|NCT02054481|E2|Reported Event|BI 655066 90 mg|90 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed 90mg BI 655066 plus one placebo matching BI 655066 injection at Weeks 4 and 16.
670342|NCT02054481|E1|Reported Event|BI 655066 18 mg|18 mg BI 655066 administered by subcutaneous injection plus two placebo matching BI 655066 injections at Week 0, followed by two placebo matching BI 655066 injections each at Weeks 4 and 16.
670343|NCT02054325|B3|Baseline|Total|Total of all reporting groups
670659|NCT02050334|O1|Outcome|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
670344|NCT02054325|B2|Baseline|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670345|NCT02054325|B1|Baseline|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670346|NCT02054325|P2|Participant Flow|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670347|NCT02054325|P1|Participant Flow|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670348|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670349|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670350|NCT02054325|O2|Outcome|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670351|NCT02054325|O1|Outcome|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670352|NCT02054325|E2|Reported Event|Glucose|"An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5ml.~Glucose: An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670353|NCT02054325|E1|Reported Event|Polidocanol With Glucose|"An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml.~Polidocanol with Glucose: An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects"
670354|NCT02053610|B3|Baseline|Total|Total of all reporting groups
670355|NCT02053610|B2|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670356|NCT02053610|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670357|NCT02053610|P2|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670358|NCT02053610|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670359|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670360|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670361|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
672149|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
670362|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670448|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670363|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670364|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670365|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670366|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670367|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670368|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670369|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670370|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670371|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670372|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670373|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670374|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670375|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670376|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670377|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670378|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670379|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670380|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670381|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670382|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670383|NCT02053610|O2|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670384|NCT02053610|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670385|NCT02053610|E2|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
670386|NCT02053610|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
670387|NCT02053493|B3|Baseline|Total|Total of all reporting groups
670388|NCT02053493|B2|Baseline|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670389|NCT02053493|B1|Baseline|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670390|NCT02053493|P2|Participant Flow|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670391|NCT02053493|P1|Participant Flow|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670392|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670393|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670394|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670395|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670396|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670397|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670398|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670399|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670400|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670401|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670724|NCT02048891|O2|Outcome|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
670449|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
707926|NCT01806857|O1|Outcome|Active Drug (Neudexta)|
670402|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670403|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670404|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670405|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670406|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670407|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670408|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670409|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670410|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670411|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670412|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670413|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670414|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670415|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670416|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670417|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670447|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
674205|NCT02017093|B2|Baseline|Control|Patients admitted to rehabilitation center after a stroke.
670418|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670419|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670420|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670421|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670422|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670423|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670424|NCT02053493|O2|Outcome|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670425|NCT02053493|O1|Outcome|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670426|NCT02053493|E2|Reported Event|Placebo Crossover to Isosorbide Mononitrate|"Isosorbide Mononitrate placebo with dose up-titration (30 to 120 mg/day over 4 weeks)~Placebo: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
670427|NCT02053493|E1|Reported Event|Isosorbide Mononitrate Crossover to Placebo|"Isosorbide Mononitrate with dose up-titration (30 to 120 mg/day over 4 weeks)~Isosorbide Mononitrate: Dispense phase 1 study drug:~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN~Dispense phase-2 study drug:~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
670428|NCT02052895|B4|Baseline|Total|Total of all reporting groups
670429|NCT02052895|B3|Baseline|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
670430|NCT02052895|B2|Baseline|Control|Patients without SIRS, sepsis, or end stage renal disease
670431|NCT02052895|B1|Baseline|Sepsis/SIRS|Patients with sepsis or SIRS
670432|NCT02052895|P3|Participant Flow|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
670433|NCT02052895|P2|Participant Flow|Control|Patients without SIRS, sepsis, or end stage renal disease
670434|NCT02052895|P1|Participant Flow|Sepsis/SIRS|Patients with sepsis or SIRS
670435|NCT02052895|O2|Outcome|Procalcitonin|ROC-AUC of procalcitonin for discriminating between Sepsis and SIRS
670436|NCT02052895|O1|Outcome|Presepsin|ROC-AUC of presepsin for discriminating between Sepsis and SIRS
670437|NCT02052895|E3|Reported Event|End Stage Renal Disease|Patients with end stage renal disease, without SIRS or sepsis
670438|NCT02052895|E2|Reported Event|Control|Patients without SIRS, sepsis, or end stage renal disease
670439|NCT02052895|E1|Reported Event|Sepsis/SIRS|Patients with sepsis or SIRS
670440|NCT02052752|B4|Baseline|Total|Total of all reporting groups
670441|NCT02052752|B3|Baseline|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670442|NCT02052752|B2|Baseline|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670443|NCT02052752|B1|Baseline|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670444|NCT02052752|P3|Participant Flow|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670445|NCT02052752|P2|Participant Flow|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670446|NCT02052752|P1|Participant Flow|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670450|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3
670451|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670452|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670453|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670454|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670455|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670456|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670457|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670458|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670459|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670460|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670461|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670462|NCT02052752|O3|Outcome|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670463|NCT02052752|O2|Outcome|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670464|NCT02052752|O1|Outcome|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670465|NCT02052752|E3|Reported Event|Positive Control|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670466|NCT02052752|E2|Reported Event|Vehicle Gel|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670467|NCT02052752|E1|Reported Event|Test Product|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
670468|NCT02052661|B1|Baseline|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670469|NCT02052661|P1|Participant Flow|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670470|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670471|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670472|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670473|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670474|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
702918|NCT01836523|B5|Baseline|Total|Total of all reporting groups
670475|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670725|NCT02048891|O1|Outcome|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
670476|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670477|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670478|NCT02052661|O1|Outcome|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670479|NCT02052661|E1|Reported Event|Engerix-B Kinder Group|Subjects who were previously primed and boosted with four doses of Infanrix™ hexa in the first two years of life, received a single dose of Engerix™-B Kinder vaccine. The vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
670480|NCT02052635|B3|Baseline|Total|Total of all reporting groups
670481|NCT02052635|B2|Baseline|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
670482|NCT02052635|B1|Baseline|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
670483|NCT02052635|P2|Participant Flow|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
670484|NCT02052635|P1|Participant Flow|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
670485|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
670486|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
670487|NCT02052635|O2|Outcome|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
670488|NCT02052635|O1|Outcome|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
670489|NCT02052635|E2|Reported Event|Clopidogrel|A single oral dose of 600 mg (300 mg tablet x2) of clopidogrel was administered at the time of the initial bivalirudin bolus administration.
670490|NCT02052635|E1|Reported Event|Ticagrelor|A single oral dose of 180 mg (90 mg tablet x2) of ticagrelor was administered at the time of the initial bivalirudin bolus administration.
670491|NCT02052544|B1|Baseline|Plasma Samples From Subjects Receiving Unfractionated Heparin|A total of 123 valid patients were recruited over three clinical centers (two in Europe, one in the US). The patients were selected from subjects receiving UFH therapy and who have given written informed consent. Excluded from the study were subjects treated with any other anticoagulants other than UFH, subjects who have been undergoing fibrinolytic therapy within the previous 4 weeks, subjects known to have a congenital bleeding disorder, subjects known to show coagulation factor deficiencies and subjects known to have a coagulation inhibitor or an unexplained APTT prolongation.
670492|NCT02052544|P1|Participant Flow|Study Patients|Patients receiving unfractionated heparin (UFH)
670493|NCT02052544|O2|Outcome|Hemosil|Sensitivity and Specificity of Hemosil
670494|NCT02052544|O1|Outcome|Pefakit|Sensitivity and Specificity of Pefakit
670495|NCT02052544|E1|Reported Event|Study Patients|Patients receiving unfractionated heparin (UFH)
670496|NCT02052466|B1|Baseline|Reverse TSA Patients|Patients having undergone reverse Total Shoulder Arthroplasty (TSA) at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670497|NCT02052466|P1|Participant Flow|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670498|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670499|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670500|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670501|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670502|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670503|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670504|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670505|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670506|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
672150|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
670507|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
709739|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
670508|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670509|NCT02052466|O1|Outcome|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670510|NCT02052466|E1|Reported Event|Reverse TSA Patients|Patients having undergone reverse TSA at the Cleveland Clinic with a high quality preoperative CT of the operative shoulder and who are at least 24 months post surgery.
670511|NCT02052414|B1|Baseline|Gralise (Gabapentin ER)|"This is an open label trial to evaluate the efficacy of Gralise against fibromyalgia pain. If subject is taking gabapentinoids at the time of enrollment, subjects will be required to wash off the medication; otherwise they can start the starter pack for Gralise, and will eventually up titrated to treatment dose of 1800mg with evening meals per day.~Subjects will be followed every 4 weeks for total of 12 weeks. At the end of 12 weeks, subjects will be wash off the Gralise over 2 weeks, and will have a final end of treatment visit at week 15.~Subjects will be asked to rate their pain on numeric pain rating system (NPRS) as primary outcome measure. Subjects will be asked to assess Fibromyalgia Impact Questionnaire (FIQ), Medical Outcome Study (MOS) Sleep questionnaire, and Patient Global Impression of Change (PGIC) as secondary outcome measures.~At each follow up visits, occurrence of adverse events, and changes to concomitant medications were evaluated and recorded."
670512|NCT02052414|P1|Participant Flow|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
670513|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
670514|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
670515|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|All subjects were assessed for occurrence of adverse events at follow up visits. All reported adverse events were tabulated, and presented in this study.
670516|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
670517|NCT02052414|O1|Outcome|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
670518|NCT02052414|E1|Reported Event|Gralise (Gabapentin ER)|"An Open label trial with Gralise. All subjects on gabapentinoids will require wash before starting trial.~All Subjects will follow the instructions on the Gralise starter pack with eventual goal of 1800 mg/day.~Subjects will be have follow up visits every 4 weeks, and at the end of 12 weeks, subjects will begin to wash off of Gralise. Visit 5 will be end of the study/ treatment visit.~Subject will rate pain ratings as primary outcome measure, and fibromyalgia impact questionnaires, medical study's outcome sleep scores, and patients global impression of change (PGIC) as secondary outcome measures. Subjects are assessed at each follow up visits for adverse events, and concomitant medication changes if any."
670519|NCT02052011|B3|Baseline|Total|Total of all reporting groups
670520|NCT02052011|B2|Baseline|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
670521|NCT02052011|B1|Baseline|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
670522|NCT02052011|P2|Participant Flow|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
670722|NCT02048891|P2|Participant Flow|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
670552|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
670523|NCT02052011|P1|Participant Flow|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
670524|NCT02052011|O2|Outcome|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
670525|NCT02052011|O1|Outcome|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
670526|NCT02052011|E2|Reported Event|Placebo Control|Subjects will take placebo pill twice daily for 4 weeks.
670527|NCT02052011|E1|Reported Event|Intervention Group|Subjects will take extended release Ranolazine for 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
670528|NCT02051816|B5|Baseline|Total|Total of all reporting groups
670529|NCT02051816|B4|Baseline|Direct Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~and~No apneic oxygenation"
670530|NCT02051816|B3|Baseline|Video Laryngoscopy and no Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~and~No apneic oxygenation"
670531|NCT02051816|B2|Baseline|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~and~A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
670532|NCT02051816|B1|Baseline|Video Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~and~A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure"
670533|NCT02051816|P4|Participant Flow|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
670534|NCT02051816|P3|Participant Flow|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
670535|NCT02051816|P2|Participant Flow|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
670536|NCT02051816|P1|Participant Flow|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
670537|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
670538|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
670539|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
670540|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
670541|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
670542|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
670543|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
670544|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
670545|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
670546|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
670547|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
670548|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
670549|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
670550|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
670551|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
670553|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
670554|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
670555|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
670556|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
670557|NCT02051816|O4|Outcome|Direct Laryngoscopy and No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Direct Laryngoscopy"
670558|NCT02051816|O3|Outcome|Video Laryngoscopy and Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy"
670559|NCT02051816|O2|Outcome|Direct Laryngoscopy and Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation"
670560|NCT02051816|O1|Outcome|Video Laryngoscopy and No Apneic Oxygenation|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~No Apneic Oxygenation"
670561|NCT02051816|O4|Outcome|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
670562|NCT02051816|O3|Outcome|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
670563|NCT02051816|O2|Outcome|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
670564|NCT02051816|O1|Outcome|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
670565|NCT02051816|O4|Outcome|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
670566|NCT02051816|O3|Outcome|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
670567|NCT02051816|O2|Outcome|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
670568|NCT02051816|O1|Outcome|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
670569|NCT02051816|E4|Reported Event|No Apneic Oxygenation|"No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure.~Video Laryngoscopy~Direct Laryngoscopy"
670570|NCT02051816|E3|Reported Event|Apneic Oxygenation|"A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure~Video Laryngoscopy~Direct Laryngoscopy"
670571|NCT02051816|E2|Reported Event|Direct Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope.~Apneic Oxygenation~No Apneic Oxygenation"
670572|NCT02051816|E1|Reported Event|Video Laryngoscopy|"Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope.~Apneic Oxygenation~No Apneic Oxygenation"
670573|NCT02051790|B1|Baseline|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
670574|NCT02051790|P1|Participant Flow|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
670575|NCT02051790|O1|Outcome|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
670576|NCT02051790|E1|Reported Event|Clinical Practice Scans|"241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.~florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice."
670577|NCT02051595|B1|Baseline|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
670723|NCT02048891|P1|Participant Flow|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
670627|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670578|NCT02051595|P1|Participant Flow|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
670579|NCT02051595|O1|Outcome|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
670580|NCT02051595|E1|Reported Event|Vancomycin Concentrations|"Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.~Vancomycin concentrations: Vancomycin concentrations will be collected in subjects who are to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration."
670581|NCT02051426|B3|Baseline|Total|Total of all reporting groups
670582|NCT02051426|B2|Baseline|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
670583|NCT02051426|B1|Baseline|D-serine First, Then Placebo|D-serine (2.1g), then placebo (corn starch)
670584|NCT02051426|P2|Participant Flow|Placebo First, Then D-serine|corn starch, then D-serine (2.1g)
670585|NCT02051426|P1|Participant Flow|D-serine First, Then Placebo|D-serine (2.1g), then Placebo (corn starch)
670586|NCT02051426|O2|Outcome|Placebo|corn starch
670587|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
670588|NCT02051426|O2|Outcome|Placebo|corn starch
670589|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
670590|NCT02051426|O2|Outcome|Placebo|corn starch
670591|NCT02051426|O1|Outcome|D-serine|D-serine (2.1g)
670592|NCT02051426|E2|Reported Event|Placebo|corn starch
670593|NCT02051426|E1|Reported Event|D-serine|D-serine (2.1g)
670594|NCT02051335|B5|Baseline|Total|Total of all reporting groups
670595|NCT02051335|B4|Baseline|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670596|NCT02051335|B3|Baseline|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670597|NCT02051335|B2|Baseline|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670598|NCT02051335|B1|Baseline|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670599|NCT02051335|P4|Participant Flow|Sequence 4 (DACB)|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670600|NCT02051335|P3|Participant Flow|Sequence 3 (CDBA)|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670626|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
672151|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
670601|NCT02051335|P2|Participant Flow|Sequence 2 (BCAD)|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670602|NCT02051335|P1|Participant Flow|Sequence 1 (ABDC)|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 1, followed by roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 2, followed by roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 3, followed by roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1, Period 4. Each treatment period is separated by a 14-day washout period.
670603|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670604|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670605|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670606|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670607|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670608|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670609|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670610|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670611|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670612|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670613|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670614|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670615|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670616|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670617|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670618|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670619|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670620|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670621|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670622|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670623|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670624|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670625|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670628|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670629|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670630|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670631|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670632|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670633|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670634|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670635|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670636|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670637|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670638|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670639|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670640|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670641|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670642|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670643|NCT02051335|O4|Outcome|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670644|NCT02051335|O3|Outcome|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670645|NCT02051335|O2|Outcome|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670646|NCT02051335|O1|Outcome|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670647|NCT02051335|E4|Reported Event|D: Roflumilast Dose A + Donepezil 10 mg|Roflumilast Dose A tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670648|NCT02051335|E3|Reported Event|C: Roflumilast Dose A|Roflumilast Dose A tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670649|NCT02051335|E2|Reported Event|B: Donepezil 10 mg|Roflumilast placebo-matching tablets, orally, donepezil 10 mg, overencapsulated tablets, orally and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670650|NCT02051335|E1|Reported Event|A: Placebo|Roflumilast placebo-matching tablets, orally, donepezil placebo-matching overencapsulated tablets, orally, and scopolamine 0.5 mg subcutaneous injection, once, Day 1 in any of the 4 treatment periods.
670651|NCT02050334|B3|Baseline|Total|Total of all reporting groups
670652|NCT02050334|B2|Baseline|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
670653|NCT02050334|B1|Baseline|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
670654|NCT02050334|P2|Participant Flow|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
670655|NCT02050334|P1|Participant Flow|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
670656|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
670657|NCT02050334|O1|Outcome|CC100 Single Doses|CC100: 2, 5, 10, and 20 mg/kg doses.
670658|NCT02050334|O2|Outcome|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
670660|NCT02050334|E2|Reported Event|CC100 (2 Single Doses) & Placebo(1 Dose)|"CC100 (2 single increasing doses by mouth) and placebo (1 single dose by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100~Placebo"
670661|NCT02050334|E1|Reported Event|CC100 (3 Single Doses)|"CC100 (3 single increasing doses by mouth). Dosing will occur every 2 to 7 days for a study duration of 5 to 15 days from the 1st dose.~CC100"
670662|NCT02050321|B1|Baseline|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
670663|NCT02050321|P1|Participant Flow|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
670664|NCT02050321|O1|Outcome|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
670665|NCT02050321|E1|Reported Event|Acitretin and Vemurafenib|"Vemurafenib is self-administered at a dose of 960 mg (four 240 mg tablets) twice daily. The first dose should be taken in the morning and the second dose should be taken in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Acitretin will initially be dosed at 25 mg orally per day with dosing altered every two weeks with a 50 mg dose.~Acitretin: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months~Vemurafenib: A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months"
670666|NCT02050048|B3|Baseline|Total|Total of all reporting groups
670667|NCT02050048|B2|Baseline|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive intravenous Lactated Ringer's solution at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
670668|NCT02050048|B1|Baseline|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
670669|NCT02050048|P2|Participant Flow|Low Volume Group (Control Arm)|In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
670670|NCT02050048|P1|Participant Flow|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
670671|NCT02050048|O2|Outcome|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period.
670672|NCT02050048|O1|Outcome|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
670673|NCT02050048|E2|Reported Event|Low Volume Group (Control Arm)|Patients will be randomized to receive intravenous Lactated Ringer's solution. In the low volume group (control arm), patients will receive fluids at the start of the ERCP. The fluids will be administered via infusion at a rate of 1.5 cc/kg/hr. Fluids may be continued through the 90 minute post-procedure observation period.
670702|NCT02049151|B3|Baseline|Total Title|
670703|NCT02049151|B2|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670726|NCT02048891|E2|Reported Event|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
670727|NCT02048891|E1|Reported Event|hCG Trigger|"Ovulation trigger with Ovitrelle 250 microgram, luteal support with vaginal progesterone: gel Crinone 8% daily.~hCG trigger"
670728|NCT02048072|B1|Baseline|Gilenya|Gilenya 0.5mg p.o. once daily
670674|NCT02050048|E1|Reported Event|High Volume Group (Intervention Arm)|"Patients will be randomized to receive intravenous Lactated Ringer's solution. In the high volume group (intervention arm), patients will receive fluids prior to, during, and after the completion of the procedure. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour~LR fluid infusion during the procedure at 5 cc/kg/hr~Post-procedure bolus of 20 cc/kg over 90 minutes"
670675|NCT02049931|B4|Baseline|Total|Total of all reporting groups
670676|NCT02049931|B3|Baseline|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
670677|NCT02049931|B2|Baseline|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks. Then, weaning period requires additional 4 weeks."
670678|NCT02049931|B1|Baseline|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
670679|NCT02049931|P3|Participant Flow|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
670680|NCT02049931|P2|Participant Flow|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
670681|NCT02049931|P1|Participant Flow|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
670682|NCT02049931|O3|Outcome|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
670683|NCT02049931|O2|Outcome|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
670684|NCT02049931|O1|Outcome|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
670685|NCT02049931|E3|Reported Event|Soft Brace Group|"Because soft back brace was a custom-made, it began to be worn when enrollment for the study. Brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.~Soft brace: In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks."
670686|NCT02049931|E2|Reported Event|Rigid Brace Group|"Patients in the rigid brace immobilization group were strictly maintained on bed rest until fitted a thoraco-lumbo-sacral orthosis. Brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.~Rigid brace: In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks."
670687|NCT02049931|E1|Reported Event|No Brace Group|"Patients in the no brace treatment group were allowed to ambulate without any braces as long as it would be tolerable.~No brace treatment: Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable."
670688|NCT02049450|B1|Baseline|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
670689|NCT02049450|P1|Participant Flow|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
670690|NCT02049450|O4|Outcome|20mg Bid|Patients who received INC422 20mg bid
670691|NCT02049450|O3|Outcome|15mg Bid|Patients who received INC422 15mg bid
670692|NCT02049450|O2|Outcome|10mg Bid|Patients who received INC422 10mg bid
670693|NCT02049450|O1|Outcome|5mg Bid|Patients who received INC422 5mg bid
670694|NCT02049450|O3|Outcome|20mg Bid|Patients who received INC422 20mg bid
670695|NCT02049450|O2|Outcome|15mg Bid|Patients who received INC422 15mg bid
670696|NCT02049450|O1|Outcome|10 mg Bid|Patients who received INC422 10mg bid
670697|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
670698|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
670699|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
670700|NCT02049450|O1|Outcome|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
670701|NCT02049450|E1|Reported Event|INC424 (Ruxolitinib) - Study Treatment|Regularly transfused adult patients with thalassemia and spleen enlargement
670704|NCT02049151|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
670705|NCT02049151|P2|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670706|NCT02049151|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
670707|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670708|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
670709|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670710|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
670711|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670712|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
670713|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670714|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
670715|NCT02049151|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 g/L) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670716|NCT02049151|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 mcg) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented.
670717|NCT02049151|E2|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the tecemotide dosing, placebo doses matched to tecemotide (L-BLP25) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until disease progression was documented.
670718|NCT02049151|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the tecemotide dosing, tecemotide (L-BLP25) (806 micrograms [mcg]) was administered weekly subcutaneously for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (806 mcg) were administered every 6 weeks until disease progression was documented
670719|NCT02048891|B3|Baseline|Total|Total of all reporting groups
670720|NCT02048891|B2|Baseline|GnRH Agonist Trigger|"ovulation trigger with Decapeptyl 0.2 mg, luteal support with 2 injections of 1,500 U hCG.~GnRH agonist trigger"
674206|NCT02017093|B1|Baseline|Study|Patients admitted to rehabilitation center after a stroke.
670732|NCT02047747|B1|Baseline|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
670733|NCT02047747|P1|Participant Flow|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
670734|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
670735|NCT02047747|O1|Outcome|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
670736|NCT02047747|E1|Reported Event|Dacomitinib|"Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.~Dacomitinib: Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days."
670737|NCT02047227|B3|Baseline|Total|Total of all reporting groups
670738|NCT02047227|B2|Baseline|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670739|NCT02047227|B1|Baseline|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670740|NCT02047227|P2|Participant Flow|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670741|NCT02047227|P1|Participant Flow|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of recombinant human chorionic gonadotrophin (r-hCG) (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670742|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670743|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670744|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670745|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670746|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670838|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670747|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670839|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670977|NCT02044991|E2|Reported Event|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
670748|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670749|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670750|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670751|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670752|NCT02047227|O2|Outcome|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670753|NCT02047227|O1|Outcome|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670754|NCT02047227|E2|Reported Event|GONAL-f|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject’s response per site standard clinical practice.
670755|NCT02047227|E1|Reported Event|Pergoveris|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 IU rhFSH/150 IU rhLH after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject’s response per site standard clinical practice.
670756|NCT02046993|B3|Baseline|Total|Total of all reporting groups
670757|NCT02046993|B2|Baseline|Hypertensive Patients on Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670758|NCT02046993|B1|Baseline|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670759|NCT02046993|P2|Participant Flow|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670760|NCT02046993|P1|Participant Flow|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670761|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670762|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670793|NCT02046772|B2|Baseline|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670763|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670840|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
709740|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
670764|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670765|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670766|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670767|NCT02046993|O2|Outcome|Hypertensive Patients on Enahnced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670768|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP + Enhanced Usual Care|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670769|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670770|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670771|NCT02046993|O2|Outcome|Hypertensive Patients on Enhanced Usual Care|"Hypertensive patients on usual care~. Patients to do HBP measurement~. Record BP readings in their diary~Hypertensive patient on usual care: Patient do home BP monitoring Record the Home BP monitoring in their diary"
670772|NCT02046993|O1|Outcome|Smart Phone Based Telemonitoring of HBP|"Smart phone based telemonitoring home blood pressure (HBP)~. Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP: Smart phone telemonitoring home Blood pressure (HBP) Patients to do home BP measurement and input into their smart phone which is sent to the central server fortnightly"
670773|NCT02046993|E2|Reported Event|Enhanced Usual Care|". Patients to do HBP measurement~. Record BP readings in their diary~Enhanced usual care: Encouraged to do HBP measurement and record BP readings in paper diary"
670774|NCT02046993|E1|Reported Event|Smart Phone Based Telemonitoring of HBP|". Patients do HBP monitoring~. record their BP readings into the smart phone with downloaded application.~Smart phone telemonitoring HBP + enhanced usual care: Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary"
670775|NCT02046980|B4|Baseline|Total|Total of all reporting groups
670776|NCT02046980|B3|Baseline|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
670777|NCT02046980|B2|Baseline|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
670778|NCT02046980|B1|Baseline|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
670779|NCT02046980|P3|Participant Flow|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
670780|NCT02046980|P2|Participant Flow|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
670781|NCT02046980|P1|Participant Flow|Gufoni|"Gufoni maneuver for apogeotropic horizontal benign paroxysmal positional vertigo (BPPV) at the first day~Gufoni"
670782|NCT02046980|O3|Outcome|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
670783|NCT02046980|O2|Outcome|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
670784|NCT02046980|O1|Outcome|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
670785|NCT02046980|E3|Reported Event|Sham|"Sham maneuver for apogeotropic horizontal BPPV at the first day~Sham"
670786|NCT02046980|E2|Reported Event|Vibration|"Vibration maneuver for apogeotropic horizontal BPPV at the first day~Vibration"
670787|NCT02046980|E1|Reported Event|Gufoni|"Gufoni maneuver for apogeotropic horizontal BPPV at the first day~Gufoni"
670788|NCT02046863|B1|Baseline|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
670789|NCT02046863|P1|Participant Flow|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
670790|NCT02046863|O1|Outcome|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
670791|NCT02046863|E1|Reported Event|Automated Programming|"Subjects will have DBS settings changed as guided by prototype DBS-Expert software. Tremor, bradykinesia, and dyskinesia will be assessed at each DBS setting.~Automated Programming: Prototype DBS-Expert software will be used to guide a clinician through DBS programming."
670792|NCT02046772|B3|Baseline|Total|Total of all reporting groups
670955|NCT02045238|B3|Baseline|Total|Total of all reporting groups
670841|NCT02046200|O1|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
676479|NCT02005029|O2|Outcome|Placebo|Mean gastric emptying time for participants receiving placebo
670794|NCT02046772|B1|Baseline|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670795|NCT02046772|P2|Participant Flow|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670796|NCT02046772|P1|Participant Flow|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670797|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670798|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670799|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670800|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670801|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670802|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670803|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670804|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670805|NCT02046772|O2|Outcome|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670806|NCT02046772|O1|Outcome|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670807|NCT02046772|E2|Reported Event|Bupivacaine Standard Dose|"People in this arm will receive treatment with the standard dose of the local intradural anaesthetic bupivacaine (5mg).~Bupivacaine standard dose: Single intradural standard dose of bupivacaine."
670808|NCT02046772|E1|Reported Event|Bupivacaine + Morphine Chloride|"People in this arm will receive treatment with morphine chloride (50 mcgr) in addition to a low dose solution of the local intradural anaesthetic bupivacaine (3mg).~Bupivacaine low dose: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural.~Morphine Chloride: A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural."
670809|NCT02046265|B5|Baseline|Total|Total of all reporting groups
670810|NCT02046265|B4|Baseline|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670811|NCT02046265|B3|Baseline|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670812|NCT02046265|B2|Baseline|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670813|NCT02046265|B1|Baseline|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670814|NCT02046265|P4|Participant Flow|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670815|NCT02046265|P3|Participant Flow|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670816|NCT02046265|P2|Participant Flow|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670817|NCT02046265|P1|Participant Flow|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670818|NCT02046265|O4|Outcome|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670819|NCT02046265|O3|Outcome|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670820|NCT02046265|O2|Outcome|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670821|NCT02046265|O1|Outcome|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670822|NCT02046265|E4|Reported Event|Offered HPV Vaccine Only|"Participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Offered HPV vaccine only: Participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670823|NCT02046265|E3|Reported Event|Step up to Prevention|"Participant receives both the knowledge session and the tailored belief sessions and the participant is offered the HPV vaccine only by their nurse practitioner in clinic. This combined intervention is call Step Up to Prevention.~Step Up to Prevention: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670824|NCT02046265|E2|Reported Event|Step Up to Prevention:Belief|"Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention:belief: Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670825|NCT02046265|E1|Reported Event|Step Up to Prevention: Knowledge|"Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.~Step Up to Prevention: knowledge: Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic."
670826|NCT02046226|B1|Baseline|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
670827|NCT02046226|P1|Participant Flow|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated in each of the case report forms.
670828|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
670829|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing~Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
670830|NCT02046226|O2|Outcome|Standard Wound Care|Standard wound care using gauze dressings per institutional standard of care.
670831|NCT02046226|O1|Outcome|OxyGenesys(TM) Dissolved Oxygen Dressing|"OxyGenesys(TM) Dissolved Oxygen Dressing~Oxygenesys(TM) Dissolved Oxygen Dressing: OxyGenesys(TM) Dissolved Oxygen Dressing"
670832|NCT02046226|E1|Reported Event|All Study Participants|The seven study subjects were treated with OxyGenesys(TM) Dissolved Oxygen Dressing or standard wound care using gauze dressings per institutional standard of care. The randomization of these subjects to either of these treatments was not indicated on each case report form.
670833|NCT02046200|B1|Baseline|IVM 30mg; Placebo|"Ivermectin (IVM): Single dose (30 mg) of a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.~Placebo: Single dose sugar pill matched to active medication."
670834|NCT02046200|P2|Participant Flow|Placebo First, Then IVM 30 mg|"First Intervention, Placebo: Single dose sugar pill, matched to active medication.~Second Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin."
670835|NCT02046200|P1|Participant Flow|IVM 30mg First, Then Placebo|"First Intervention, Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.~Second Intervention, Placebo: Single dose sugar pill, matched to active medication."
670836|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
706543|NCT01813721|O2|Outcome|General Hospital|
670842|NCT02046200|O6|Outcome|IVM 30mg (BrAC = 0.08)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.08.
670843|NCT02046200|O5|Outcome|IVM 30mg (BrAC = 0.04)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is during alcohol infusion when BrAC has reached 0.04.
670844|NCT02046200|O4|Outcome|IVM 30mg (BrAC = 0.00)|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
670845|NCT02046200|O3|Outcome|Placebo (BrAC = 0.08)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.08.
670846|NCT02046200|O2|Outcome|Placebo (BrAC = 0.04)|Single dose sugar pill, matched to active medication. Timepoint is during alcohol infusion when BrAC has reached 0.04.
670847|NCT02046200|O1|Outcome|Placebo (BrAC = 0.00)|Single dose sugar pill, matched to active medication. Timepoint is at beginning of alcohol infusion when BrAC is still 0.00.
670848|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670849|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670850|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670851|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670852|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670853|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670854|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670855|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670856|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670857|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670858|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670859|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670860|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670861|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670862|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670863|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670864|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670865|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670866|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670867|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670868|NCT02046200|O2|Outcome|IVM 30mg|Ivermectin (IVM): Single dose (30 mg) of semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum anti parasitic avermectin.
670869|NCT02046200|O1|Outcome|Placebo|Single dose sugar pill, matched to active medication.
670870|NCT02046200|E2|Reported Event|Placebo|"Matched placebo, single dose~Placebo: sugar pill~Alcohol"
670871|NCT02046200|E1|Reported Event|IVM 30mg|"Ivermectin 30 mg single dose~Ivermectin: Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.~Alcohol"
670872|NCT02046148|B3|Baseline|Total|Total of all reporting groups
670873|NCT02046148|B2|Baseline|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670874|NCT02046148|B1|Baseline|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670875|NCT02046148|P2|Participant Flow|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670876|NCT02046148|P1|Participant Flow|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670973|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
670877|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670974|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
670878|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670879|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670880|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670881|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670882|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670883|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670884|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670885|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670886|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670887|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670888|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670889|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670890|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670891|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670892|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670893|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670894|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670895|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
671063|NCT02044302|O1|Outcome|Terminated Cohort|
671064|NCT02044302|O1|Outcome|Terminated Cohort|
670896|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670897|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670898|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670899|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670900|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670901|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670902|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670903|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670904|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670905|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670906|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670907|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670908|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670909|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670910|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670911|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670912|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670913|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670914|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
671065|NCT02044302|E1|Reported Event|Terminated Cohort|
670915|NCT02046148|O2|Outcome|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
709741|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
670916|NCT02046148|O1|Outcome|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670917|NCT02046148|E2|Reported Event|Placebo Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Placebo, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670918|NCT02046148|E1|Reported Event|GBS Group|Healthy pregnant women, between and including 18-40 years of age, at 24 0/7 through 34 6/7 weeks of gestation, with the intent to breastfeed, who received a single dose of Group B Streptococcus (GBS) trivalent vaccine, injected intramuscularly. (Pregnant women are referred to as maternal subjects as the study period spans from pregnancy to Day 180 postpartum).
670919|NCT02045732|B3|Baseline|Total|Total of all reporting groups
670920|NCT02045732|B2|Baseline|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670921|NCT02045732|B1|Baseline|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670922|NCT02045732|P2|Participant Flow|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 milligram (mg)/kilogram (kg) SC every other week during an 85-day treatment period.
670923|NCT02045732|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every other week during an 85-day treatment period.
670924|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670925|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670926|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670927|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670928|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670929|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670930|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670931|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670932|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670933|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670934|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670935|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670936|NCT02045732|O2|Outcome|PF-06342674 0.25 mg/kg|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670937|NCT02045732|O1|Outcome|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670938|NCT02045732|E2|Reported Event|PF-06342674|Participants received PF-06342674 0.25 mg/kg SC every other week during an 85-day treatment period.
670939|NCT02045732|E1|Reported Event|Placebo|Participants received placebo SC every other week during an 85-day treatment period.
670940|NCT02045264|B1|Baseline|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670941|NCT02045264|P1|Participant Flow|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670942|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670943|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670944|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670945|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670946|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670947|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670948|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670949|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670950|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670951|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670952|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670953|NCT02045264|O1|Outcome|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670954|NCT02045264|E1|Reported Event|Icatibant (30 mg)|Subjects received a 30mg dose of icatibant administered as a single subcutaneous injection in the abdominal area on Day 1.
670975|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
670976|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
709742|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
670956|NCT02045238|B2|Baseline|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670957|NCT02045238|B1|Baseline|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670958|NCT02045238|P2|Participant Flow|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670959|NCT02045238|P1|Participant Flow|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670960|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670961|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670962|NCT02045238|O2|Outcome|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670963|NCT02045238|O1|Outcome|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670964|NCT02045238|E2|Reported Event|Hypertonic Saline|"Patients will receive inhaled Hypertonic Saline 3%, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Hypertonic Saline: Sodium Chloride 3% solution, previously prepared in 5 mL syringes.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670965|NCT02045238|E1|Reported Event|Normal Saline|"Patients will receive inhaled normal saline, initially with a 2 hour interval, and clinical evaluation prior to each inhalation. When they attain sat>94% AND respiratory rate <60 AND RDAI score <4, the interval between inhalations will be changed to 4 hours. If they maintain these criteria for a whole 4 hour interval, they are discharged. If they do not improve enough to be discharged in 24 hours from the first inhalation, they are considered as admitted to hospital.~Chest X-Ray~Respiratory virus screening test: Immunofluorescence analysis of nasal aspirate"
670966|NCT02044991|B3|Baseline|Total|Total of all reporting groups
670967|NCT02044991|B2|Baseline|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
670968|NCT02044991|B1|Baseline|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
670969|NCT02044991|P2|Participant Flow|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
670970|NCT02044991|P1|Participant Flow|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
670971|NCT02044991|O2|Outcome|Placebo|Participant's randomized to this condition receive a saline injection with lidocaine.
670972|NCT02044991|O1|Outcome|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
670978|NCT02044991|E1|Reported Event|Treatment|Participants randomized to this arm receive an injectable anti-inflammatory medication (methylprednisolone acetate) plus lidocaine
670979|NCT02044848|B3|Baseline|Total|Total of all reporting groups
670980|NCT02044848|B2|Baseline|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670981|NCT02044848|B1|Baseline|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670982|NCT02044848|P2|Participant Flow|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670983|NCT02044848|P1|Participant Flow|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670984|NCT02044848|O2|Outcome|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670985|NCT02044848|O1|Outcome|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670986|NCT02044848|E2|Reported Event|Placebo|Placebo will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670987|NCT02044848|E1|Reported Event|Secukinumab|Secukinumab will be delivered as part of an induction regimen followed by a maintenance regimen for up to 1 year
670988|NCT02044822|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670989|NCT02044822|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670990|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670991|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670992|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670993|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670994|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670995|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670996|NCT02044822|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670997|NCT02044822|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet twice daily + rituximab 375 mg/m^2 intravenously once weekly for 8 weeks
670998|NCT02044458|B3|Baseline|Total|Total of all reporting groups
670999|NCT02044458|B2|Baseline|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
671000|NCT02044458|B1|Baseline|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
671001|NCT02044458|P2|Participant Flow|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
671002|NCT02044458|P1|Participant Flow|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
671003|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
671004|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
671005|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
671006|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
671007|NCT02044458|O2|Outcome|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
671008|NCT02044458|O1|Outcome|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
671009|NCT02044458|E2|Reported Event|No Stylette|No Stylette: 22 French Foley catheter placed without stylette or guide.
671010|NCT02044458|E1|Reported Event|Stylette|"Stylette: a thin wire inserted into a catheter to maintain rigidity, used to guide the insertion of the Foley catheter.~Stylette: use of stylette for successful insertion of foley catheter for induction of labor"
671011|NCT02044393|B3|Baseline|Total|Total of all reporting groups
671012|NCT02044393|B2|Baseline|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
671066|NCT02043808|B3|Baseline|Total|Total of all reporting groups
671067|NCT02043808|B2|Baseline|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671036|NCT02044367|P2|Participant Flow|T1-R-T2|T1: pellets on food; R: hard capsule; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671069|NCT02043808|P2|Participant Flow|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671013|NCT02044393|B1|Baseline|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
671014|NCT02044393|P2|Participant Flow|BI 691751 / IT+BI 691751|"Subjects in treatment sequence of reference drug treatment in period 1, then tested drug treatment in period 2 (R/T): One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 1. Two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total), and, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 2.~Oral administration with 240 mL water after intake of a standaridsed meal."
671015|NCT02044393|P1|Participant Flow|Itraconazole (IT) +BI 691751 / BI 691751|"Subjects in treatment sequence of tested drug treatment in period 1, then reference drug treatment in period 2 (T/R): two capsules of 100 mg itraconazole were given twice daily on Day -3 (loading dose) and once daily on Day -2 to Day 7 (10 days of itraconazol treatment in total). In addition, 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 (corresponding to the fourth day of the 10-day itraconazole treatment) in period 1. One tablet of 10 mg BI 691751 was given as a single dose on Day 1 in period 2.~The BI 691751 single dose administrations in the 2 treatment periods were separated by a washout period of at least 7 weeks.~Oral administration with 240 mL water after intake of a standardised meal."
671016|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
671017|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
671018|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
671019|NCT02044393|O1|Outcome|BI 691751|10 mg BI 691751 single dose oral administration with 240 mL water after intake of a standard meal.
671020|NCT02044393|O2|Outcome|IT + BI 691751|Two capsules of 100 mg IT were given twice daily on Day -3 and once daily on Day -2 to Day 7. 1 tablet of 10 mg BI 691751 was given as a single dose on Day 1 with 240 mL water after intake of a standard meal.
671021|NCT02044393|O1|Outcome|BI 691751|"single dose BI 691751~BI 691751: 10 mg single dose oral administration with 240 mL water after intake of a standard meal."
671022|NCT02044393|E5|Reported Event|Total on Treatment|combination of BI 691751, loading IT and BI 691751+ further IT.
671023|NCT02044393|E4|Reported Event|Total BI 691751|total subjects with BI 691751 treatment (either BI 691751 alone or IT+BI 691751)
671024|NCT02044393|E3|Reported Event|BI 691751 + Further IT|10 mg of BI 691751 in combination with multiple oral doses of itraconazole (only in the test treatment period after the introductory treatment with itraconazole alone over three days).
671025|NCT02044393|E2|Reported Event|Loading Itraconazole (IT)|200 mg of itraconazole (introductory treatment with itraconazole over three days, prior to the first administration of BI 691751 only in the test treatment period).
671026|NCT02044393|E1|Reported Event|BI 691751|10 mg single dose oral administration with 240 mL water after intake of a standard meal. (only in the reference treatment period)
671027|NCT02044380|B1|Baseline|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
671028|NCT02044380|P1|Participant Flow|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
671029|NCT02044380|O1|Outcome|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
671030|NCT02044380|E1|Reported Event|Afatinib 40 mg|Patient to receive a film coated tablet containing 40 mg afatinib once a day, with the option to reduce the dose to 30 or 20 mg/day, based on individual tolerability.
671031|NCT02044367|B1|Baseline|Overall|A randomised, open-label, 3-way crossover, multiple dose trial consisting of 3 identical treatment periods of 3 days. Study drug (150 mg dabigatran etexilate) was administrated twice daily on Day 1 and Day 2 and once on Day 3. The dosage forms used were: hard capsule, granules resolved in reconstitution solution and pellets on food. Treatment periods were separated by a washout phase of at least 5 days between last drug administration of one treatment and the first drug administration of the next treatment.
671032|NCT02044367|P6|Participant Flow|R-T2-T1|R: hard capsule; T2: granules for reconstitution into solution; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671033|NCT02044367|P5|Participant Flow|R-T1-T2|R: hard capsule; T1: pellets on food; T2: granules for reconstitution into solution. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671034|NCT02044367|P4|Participant Flow|T2-R-T1|T2: granules for reconstitution into solution; R: hard capsule; T1: pellets on food. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671035|NCT02044367|P3|Participant Flow|T2-T1-R|T2: granules for reconstitution into solution; T1: pellets on food; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671198|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
671037|NCT02044367|P1|Participant Flow|T1-T2-R|T1: pellets on food; T2: granules for reconstitution into solution; R: hard capsule. The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671038|NCT02044367|O2|Outcome|T2 (Treatment B)|"T2: Granules resolved in reconstitution solution~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
671039|NCT02044367|O1|Outcome|T1 (Treatment A)|"T1: Pellets on food~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water."
671040|NCT02044367|O2|Outcome|T2 (Treatment B)|T2: Granules resolved in reconstitution solution The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
671041|NCT02044367|O1|Outcome|T1 (Treatment A)|T1: Pellets on food The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for both treatments T1 and T2. All treatments were administered orally with 240 mL of water.
671042|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671043|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671044|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671045|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671046|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671047|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671048|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671049|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671050|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671051|NCT02044367|O3|Outcome|R (Reference)|"multiple dose of dabigatran (Hard capsule)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671052|NCT02044367|O2|Outcome|T2 (Treatment B)|"multiple dose of dabigatran (Granules resolved in reconstitution solution)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671053|NCT02044367|O1|Outcome|T1 (Treatment A)|"multiple dose of dabigatran (Pellets)~The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water."
671054|NCT02044367|E3|Reported Event|R (Reference)|multiple dose of dabigatran (Hard capsule) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671055|NCT02044367|E2|Reported Event|T2 (Treatment B)|multiple dose of dabigatran (Granules resolved in reconstitution solution) The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671056|NCT02044367|E1|Reported Event|T1 (Treatment A)|multiple dose of dabigatran (Pellets). The treatments were 150 mg dabigatran etexilate twice daily on Days 1 and 2 and once after an overnight fast of at least 10 hours on Day 3 for all treatments T1, T2 and R. All treatments were administered orally with 240 mL of water.
671057|NCT02044302|B3|Baseline|Total|Total of all reporting groups
671058|NCT02044302|B2|Baseline|Blinded Group B|
671059|NCT02044302|B1|Baseline|Blinded Group A|
671060|NCT02044302|P2|Participant Flow|Blinded Group B|
671061|NCT02044302|P1|Participant Flow|Blinded Group A|
671062|NCT02044302|O1|Outcome|Terminated Cohort|
671068|NCT02043808|B1|Baseline|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
709743|NCT01791725|E3|Reported Event|Placebo|"Placebo BID~Placebo"
671070|NCT02043808|P1|Participant Flow|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671071|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671072|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671073|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671074|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671075|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671076|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671077|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671078|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671079|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671080|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671081|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671082|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671083|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671084|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671085|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671086|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671087|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671088|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671089|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671090|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671091|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671092|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671093|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671244|NCT02042872|B3|Baseline|Total|Total of all reporting groups
671094|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671095|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671096|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671097|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671098|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671099|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671100|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671101|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671102|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671103|NCT02043808|O2|Outcome|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671104|NCT02043808|O1|Outcome|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671105|NCT02043808|E2|Reported Event|Warfarin|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for warfarin during the study identification period (1 October 2010 and 31 July 2012).
671106|NCT02043808|E1|Reported Event|Dabigatran|Oral anticoagulant treatment-naive non-valvular atrial fibrillation (NVAF) patients aged 18-89 with their first prescription claim for dabigatran (either FDA-approved dose) during the study identification period (1 October 2010 and 31 July 2012).
671107|NCT02043782|B1|Baseline|All Subjects|Pooled data from all arms.
671108|NCT02043782|P6|Participant Flow|Test - Own - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Own product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
671109|NCT02043782|P5|Participant Flow|Own - Competitor - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Competitor soft convex product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
671110|NCT02043782|P4|Participant Flow|Competitor - Test - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Coloplast test product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
671111|NCT02043782|P3|Participant Flow|Own - Test - Competitor|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Own product Coloplast test product Competitor soft convex product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
671112|NCT02043782|P2|Participant Flow|Competitor - Own - Test|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Competitor soft convex product Own product Coloplast test product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject´s own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
671135|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671136|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671200|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
671113|NCT02043782|P1|Participant Flow|Test - Competitor - Own|"The subjects were randomized into six possible treatment groups:~The order of test products for this group was:~Coloplast test product Competitor soft convex product Own product~Coloplast Test: Newly developed 1-piece convex ostomy product~Own product: The subject's own product was used as baseline performance in this investigation. The products are commercially available on the market, and are products manufactured by manufactures who produce convex ostomy products, i.e. Coloplast, Convatec, Dansac, B. Braun, Hollister and more.~Competitor soft convex: A commercially available soft convex product"
671114|NCT02043782|O3|Outcome|Competitor Soft Convex|Subjects testing Competitor Soft Convex
671115|NCT02043782|O2|Outcome|Own Product|Subjects testing own product
671116|NCT02043782|O1|Outcome|Coloplast Test Product|Subjects testing Coloplast test product
671117|NCT02043782|E3|Reported Event|Competitor Soft Convex|Adverse events reported by subjects testing Competitor soft convex
671118|NCT02043782|E2|Reported Event|Own Product|Adverse events reported by subjects testing own product
671119|NCT02043782|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
671120|NCT02043379|B3|Baseline|Total|Total of all reporting groups
671121|NCT02043379|B2|Baseline|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671122|NCT02043379|B1|Baseline|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671123|NCT02043379|P2|Participant Flow|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671124|NCT02043379|P1|Participant Flow|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671125|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671126|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671127|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671128|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671129|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671130|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671131|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671132|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671133|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671134|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
672152|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
671137|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671138|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671139|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671140|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671141|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671142|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671143|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671144|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671145|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671146|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671147|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671148|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671149|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671150|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671151|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671152|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671153|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671154|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671155|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671156|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671157|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671158|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671159|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671160|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671161|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671162|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671163|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671164|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671165|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671166|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671167|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671168|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671169|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671170|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671171|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671172|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671173|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671174|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671175|NCT02043379|O2|Outcome|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671176|NCT02043379|O1|Outcome|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671177|NCT02043379|E2|Reported Event|Normal Saline|"Subject's randomized into the placebo arm of the study will receive a volume of normal saline that is comparative to that if they were to receive IVIG. This will be at 12 hours post-cardiopulmonary bypass. This volume is to ensure blinding of study drug.~Placebo: If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight."
671178|NCT02043379|E1|Reported Event|IVIG|"Those randomized to the study arm will receive a dose of IVIG 1 gram/kg at 12 hours post-cardiopulmonary bypass. This is a one time only dose.~IVIG: Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care."
671179|NCT02043366|B7|Baseline|Total|Total of all reporting groups
671180|NCT02043366|B6|Baseline|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
671181|NCT02043366|B5|Baseline|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
671182|NCT02043366|B4|Baseline|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
671183|NCT02043366|B3|Baseline|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671184|NCT02043366|B2|Baseline|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671185|NCT02043366|B1|Baseline|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
671186|NCT02043366|P6|Participant Flow|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil.
671187|NCT02043366|P5|Participant Flow|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/kg butorphanol and a dose of 0.5mg/kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
671188|NCT02043366|P4|Participant Flow|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil.
671189|NCT02043366|P3|Participant Flow|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671190|NCT02043366|P2|Participant Flow|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671191|NCT02043366|P1|Participant Flow|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
671192|NCT02043366|O6|Outcome|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
671193|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil
671194|NCT02043366|O4|Outcome|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentanil
671195|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671196|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671197|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
672153|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
671199|NCT02043366|O5|Outcome|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil.
672301|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
671201|NCT02043366|O3|Outcome|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671202|NCT02043366|O2|Outcome|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671203|NCT02043366|O1|Outcome|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
671204|NCT02043366|E6|Reported Event|Sufentanil|Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with sufentanil
671205|NCT02043366|E5|Reported Event|Butorphanol-Flurbiprofen Axetil|A dose of 10μg/ kg butorphanol and a dose of 0.5mg/ kg flurbiprofen axetil are intravenously administrated before anesthesia induction and intraoperative pain management was with remifentani
671206|NCT02043366|E4|Reported Event|Butorphanol|Butorphanol is intravenously administrated at a dose of 20μg/ kg before anesthesia induction and intraoperative pain management was with remifentani
671207|NCT02043366|E3|Reported Event|Flurbiprofen AxetilⅡ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before the skin closure and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671208|NCT02043366|E2|Reported Event|Flurbiprofen AxetilⅠ|"Flurbiprofen axetil is intravenously administrated at a dose of 1.0mg/ kg before anesthesia induction and intraoperative pain management was with remifentanil~Flurbiprofen axetil: Flurbiprofen axetil is intravenously administrated"
671209|NCT02043366|E1|Reported Event|Normal Saline|"Normal saline is intravenously administrated before anesthesia induction and intraoperative pain management was with remifentanil~Normal Saline"
671210|NCT02043145|B4|Baseline|Total|Total of all reporting groups
671211|NCT02043145|B3|Baseline|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671212|NCT02043145|B2|Baseline|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671213|NCT02043145|B1|Baseline|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671214|NCT02043145|P3|Participant Flow|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671215|NCT02043145|P2|Participant Flow|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671216|NCT02043145|P1|Participant Flow|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671217|NCT02043145|O1|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671218|NCT02043145|O1|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671219|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671220|NCT02043145|O3|Outcome|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671221|NCT02043145|O2|Outcome|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671222|NCT02043145|O1|Outcome|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671223|NCT02043145|E3|Reported Event|Glabellar Lines|Patients with moderate or severe Glabellar Lines who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671224|NCT02043145|E2|Reported Event|Focal Spasticity|Patients with Focal Spasticity who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671225|NCT02043145|E1|Reported Event|Axillary Hyperhidrosis|Patients with Axillary Hyperhidrosis who are treated with BOTOX® (botulinum toxin Type A) as prescribed according to standard of care in clinical practice.
671226|NCT02042924|B1|Baseline|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
671227|NCT02042924|P1|Participant Flow|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
671245|NCT02042872|B2|Baseline|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
676477|NCT02005029|O2|Outcome|Placebo|Area under the curve 0-4 hours for plasma levodopa after placebo
671228|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
671229|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
671230|NCT02042924|O1|Outcome|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
671231|NCT02042924|E1|Reported Event|Imaging Studies|"Subjects will have a FLT PET/CT and a MRI prior to starting the preparative regimen for transplant and another of each scan 100 days after transplant.~FLT PET/CT: Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).~MRI: MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days)."
671232|NCT02042911|B1|Baseline|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671233|NCT02042911|P1|Participant Flow|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671234|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671235|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671236|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671237|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671238|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671239|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671240|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671241|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671242|NCT02042911|O1|Outcome|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671243|NCT02042911|E1|Reported Event|SyB L-0501|SyB L-0501: SyB L-0501 is administered at 100 mg/m^2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
671246|NCT02042872|B1|Baseline|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
671247|NCT02042872|P2|Participant Flow|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
671248|NCT02042872|P1|Participant Flow|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
671249|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
671250|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
671251|NCT02042872|O2|Outcome|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
671252|NCT02042872|O1|Outcome|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
671253|NCT02042872|E2|Reported Event|No Treatment|Participants will receive no therapy and serve as a control group and have the same outcome measures completed at parallel time points.
671254|NCT02042872|E1|Reported Event|Zoledronic Acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
671255|NCT02042534|B3|Baseline|Total|Total of all reporting groups
671256|NCT02042534|B2|Baseline|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671257|NCT02042534|B1|Baseline|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671258|NCT02042534|P2|Participant Flow|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671259|NCT02042534|P1|Participant Flow|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671260|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671261|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671262|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671263|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671297|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
676589|NCT02004847|O2|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
671299|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
677632|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
671264|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671265|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671266|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671267|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671268|NCT02042534|O2|Outcome|Warfarin|"Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671269|NCT02042534|O1|Outcome|Rivaroxaban|"Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671270|NCT02042534|E2|Reported Event|Warfarin|"Safety population : 90 (patients)~Patients allocated to warfarin receive warfarin plus aspirin 100mg until INR value exceed 1.7 followed by warfarin monotherapy with target INR value of 2.5 [2.0 – 3.0].~Warfarin: To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care."
671271|NCT02042534|E1|Reported Event|Rivaroxaban|"Safety population : 98 (patients)~Rivaroxaban group for 1 month : initial 5 days after randomization rivaroxaban 10mg QD will be administered. Rivaroxaban 20mg QD, but 15mg in case of Cr CL will be administered for remaining 25 days.~Rivaroxaban: Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
671272|NCT02042404|B1|Baseline|Mild to Severe Hearing Impairment|Subjects wearing the Earlens System in their daily lives.
671273|NCT02042404|P2|Participant Flow|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
671274|NCT02042404|P1|Participant Flow|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
671275|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
671276|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
671298|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671277|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
671278|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
671279|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
671280|NCT02042404|O1|Outcome|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
671281|NCT02042404|O2|Outcome|Roll-in Cohort: Mild to Severe Hearing Impairment|Roll-in Cohort are evaluated for safety only, and are not included in efficacy endpoint evaluation.
671282|NCT02042404|O1|Outcome|Primary Cohort: Mild to Severe Hearing Impairment|"Sound amplification provided via the EarLens System assistive hearing device.~Sound amplification provided via EarLens System.: The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time."
671283|NCT02042404|E1|Reported Event|Mild to Severe Hearing Impairment|Both Primary Cohort and Roll-in Cohorts are combined for safety analysis.
671284|NCT02042274|B1|Baseline|Fish Oil|Fish oil supplements providing up to 3g per day of EPA and DHA, for 90 days.
671285|NCT02042274|P1|Participant Flow|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.~Measurements are made at three time points: Baseline (Day 0 - before beginning fish oil supplementation), 3 months (Day 90 - after fish oil supplementation), and 5 months (Day 150 - 2 month washout)."
671286|NCT02042274|O1|Outcome|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
671287|NCT02042274|O1|Outcome|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
671288|NCT02042274|E1|Reported Event|Fish Oil Supplement|"Fish oil supplements providing up to 3g per day of EPA and DHA~Fish oil supplement: Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period."
671289|NCT02041520|B3|Baseline|Total|Total of all reporting groups
671290|NCT02041520|B2|Baseline|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671291|NCT02041520|B1|Baseline|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671292|NCT02041520|P2|Participant Flow|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671293|NCT02041520|P1|Participant Flow|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671294|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671295|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671296|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671337|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
671300|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671301|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671302|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671303|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671304|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671305|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671306|NCT02041520|O2|Outcome|Placebo|Patiemts who received placebo for 6 months
671307|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|Patients who received omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and 2 in the night...
671308|NCT02041520|O2|Outcome|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671309|NCT02041520|O1|Outcome|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671310|NCT02041520|E2|Reported Event|Placebo|"Placebo (olive oil gelcaps) in similar presentation as omega 3 fatty acids, requiring intake 2 capsules in the morning and two at night (Perfect Source, Fullerton CA, product code number PER 1016, lot number 8A0019/1600-1)~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671311|NCT02041520|E1|Reported Event|Omega 3 Fatty Acids|"omega 3 fatty acids, 2.4 g per day, requiring intake 2 capsules (600mg each one) in the morning and two at night (Zonelabs, Marblehead MA) for 6 months.~omega 3 fatty acids: omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up."
671312|NCT02041377|B1|Baseline|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
671313|NCT02041377|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
671314|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
671338|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject capillary blood and BG results are compared to reference method results obtained from subject capillary plasma.
671339|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
671340|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
706544|NCT01813721|O1|Outcome|University Hospital|
671341|NCT02041286|O1|Outcome|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
672246|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
671315|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
671316|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
671317|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
671318|NCT02041377|O1|Outcome|Intended Users of the Monitoring System|"Subjects with diabetes used the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma."
671319|NCT02041377|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi TS Investigational Blood Glucose Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi TS Investigational Blood Glucose Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
671320|NCT02041325|B3|Baseline|Total|Total of all reporting groups
671321|NCT02041325|B2|Baseline|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
671322|NCT02041325|B1|Baseline|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
671323|NCT02041325|P2|Participant Flow|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
671324|NCT02041325|P1|Participant Flow|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
671325|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
671326|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
671327|NCT02041325|O2|Outcome|Placebo|"Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.~Placebo: Subjects will receive placebo for 7 days prior to and 7 days after the vaccine."
671328|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine."
671329|NCT02041325|O2|Outcome|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
671330|NCT02041325|O1|Outcome|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
671331|NCT02041325|O2|Outcome|Placebo|"Placebo will be administered for 7 days prior to and 7 days after the vaccine.~Placebo: Placebo will be administered for 7 days prior to and 7 days after the vaccine."
671332|NCT02041325|O1|Outcome|Lenalidomide|"Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks.~Lenalidomide: Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd or placebo for 2 weeks."
671333|NCT02041325|E2|Reported Event|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
671334|NCT02041325|E1|Reported Event|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
671335|NCT02041286|B1|Baseline|Intended Users of the Monitoring System|Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training.
671336|NCT02041286|P1|Participant Flow|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
671342|NCT02041286|E1|Reported Event|Intended Users of the Monitoring System|"Subjects with diabetes use the Karajishi Contour Investigational BG Monitoring System with no training. The criteria for the intended use population:~At least 60% of subjects will be younger than age 65~At least 10% of subjects will have type 1 diabetes~Karajishi Contour Investigational BG Monitoring System: Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma."
671343|NCT02041221|B7|Baseline|Total|Total of all reporting groups
671344|NCT02041221|B6|Baseline|Placebo|
671345|NCT02041221|B5|Baseline|S0597 Dose 5|
671346|NCT02041221|B4|Baseline|S0597 Dose 4|
671347|NCT02041221|B3|Baseline|S0597 Dose 3|
671348|NCT02041221|B2|Baseline|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
671349|NCT02041221|B1|Baseline|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
671350|NCT02041221|P6|Participant Flow|Placebo|Subjects will receive placebo
671351|NCT02041221|P5|Participant Flow|S0597 Dose 5|Subjects will receive SPARC1316 dose 5
671352|NCT02041221|P4|Participant Flow|S0597 Dose 4|Subjects will receive SPARC1316 dose 4
671353|NCT02041221|P3|Participant Flow|S0597 Dose 3|Subjects will receive SPARC1316 dose 3
671354|NCT02041221|P2|Participant Flow|S0597 Dose 2|Subjects will receive SPARC1316 dose 2
671355|NCT02041221|P1|Participant Flow|S0597 Dose 1|Subjects will be administered with SPARC1316 dose 1
671356|NCT02041221|O6|Outcome|Placebo|
671357|NCT02041221|O5|Outcome|S0597 Dose 5|
671358|NCT02041221|O4|Outcome|S0597 Dose 4|
671359|NCT02041221|O3|Outcome|S0597 Dose 3|
671360|NCT02041221|O2|Outcome|S0597 Dose 2|
671361|NCT02041221|O1|Outcome|S0597 Dose 1|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
671362|NCT02041221|E6|Reported Event|Placebo|
671363|NCT02041221|E5|Reported Event|S0597 Dose 5|
671364|NCT02041221|E4|Reported Event|S0597 Dose 4|
671365|NCT02041221|E3|Reported Event|S0597 Dose 3|
671366|NCT02041221|E2|Reported Event|S0597 Dose 2|"The subjects will receive placebo.~S0597: The subjects will receive S0597.~Placebo"
671367|NCT02041221|E1|Reported Event|S0597 Dose 1|"Subjects will be administered with S0597~S0597: The subjects will receive S0597.~Placebo"
671368|NCT02040792|B6|Baseline|Total|Total of all reporting groups
671369|NCT02040792|B5|Baseline|350 mcg|"TD-4208~TD-4208"
671370|NCT02040792|B4|Baseline|175 mcg|"TD-4208~TD-4208"
671371|NCT02040792|B3|Baseline|88 mcg|"TD-4208~TD-4208"
671372|NCT02040792|B2|Baseline|44 mcg|"TD-4208~TD-4208"
671373|NCT02040792|B1|Baseline|Placebo|"Placebo~Placebo"
671374|NCT02040792|P5|Participant Flow|350 mcg|"TD-4208~TD-4208"
671375|NCT02040792|P4|Participant Flow|175 mcg|"TD-4208~TD-4208"
671376|NCT02040792|P3|Participant Flow|88 mcg|"TD-4208~TD-4208"
671377|NCT02040792|P2|Participant Flow|44 mcg|"TD-4208~TD-4208"
671378|NCT02040792|P1|Participant Flow|Placebo|"Placebo~Placebo"
671379|NCT02040792|O5|Outcome|350 mcg|"TD-4208~TD-4208"
671380|NCT02040792|O4|Outcome|175 mcg|"TD-4208~TD-4208"
671381|NCT02040792|O3|Outcome|88 mcg|"TD-4208~TD-4208"
671382|NCT02040792|O2|Outcome|44 mcg|"TD-4208~TD-4208"
671383|NCT02040792|O1|Outcome|Placebo|"Placebo~Placebo"
671384|NCT02040792|E5|Reported Event|350 mcg|"TD-4208~TD-4208"
671385|NCT02040792|E4|Reported Event|175 mcg|"TD-4208~TD-4208"
671386|NCT02040792|E3|Reported Event|88 mcg|"TD-4208~TD-4208"
671387|NCT02040792|E2|Reported Event|44 mcg|"TD-4208~TD-4208"
671388|NCT02040792|E1|Reported Event|Placebo|"Placebo~Placebo"
671389|NCT02040623|B4|Baseline|Total|Total of all reporting groups
671390|NCT02040623|B3|Baseline|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
671391|NCT02040623|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
671392|NCT02040623|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
671393|NCT02040623|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
671394|NCT02040623|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
671395|NCT02040623|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
671396|NCT02040623|O3|Outcome|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
671397|NCT02040623|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
671398|NCT02040623|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
671399|NCT02040623|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution 2 drops per eye twice a day~Placebo Ophthalmic Solution: Placebo Ophthalmic Solution 2 drops per eye twice a day"
671400|NCT02040623|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day"
672163|NCT02037477|E1|Reported Event|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
671401|NCT02040623|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day"
671402|NCT02040532|B1|Baseline|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671403|NCT02040532|P1|Participant Flow|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671404|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671405|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671406|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671407|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671408|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671409|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671410|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671411|NCT02040532|O1|Outcome|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671412|NCT02040532|E1|Reported Event|Open-label Gabapentin|"Dose titration of 100mg for 1 week, 300mg for 3 weeks, and 600mg for 3 weeks.~Gabapentin: The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks."
671413|NCT02039817|B3|Baseline|Total|Total of all reporting groups
671414|NCT02039817|B2|Baseline|Severe Renal Impairment|Severe Renal Impairment subjects received one 50mg dose of IDN-6556
671415|NCT02039817|B1|Baseline|Healthy Volunteers|Health Volunteers received one 50mg dose of IDN-6556
671416|NCT02039817|P2|Participant Flow|Severe Renal Impairment|Severe Renal Impairment subjects were given a single 50mg dose of IDN-6556
671417|NCT02039817|P1|Participant Flow|Healthy Volumteers|Healthy volunteers were given a single 50mg dose of IDN-6556
671418|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
671419|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
671420|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
671421|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
671422|NCT02039817|O2|Outcome|Severe Renal Impairment|Subjects received a single 50 mg oral dose of IDN-6556
671423|NCT02039817|O1|Outcome|Healthy Volunteers|Subjects received a single 50 mg oral dose of IDN-6556
671424|NCT02039817|E1|Reported Event|IDN-6556|A single 50mg dose of IDN-6556
671425|NCT02039778|B1|Baseline|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671426|NCT02039778|P1|Participant Flow|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671427|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671428|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671429|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671430|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671464|NCT02039687|E2|Reported Event|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671431|NCT02039778|O1|Outcome|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671432|NCT02039778|E1|Reported Event|Stem Cell Radiotherapy and Temozolomide|"Intensity Modulated Radiation Therapy (IMRT) Is Mandated; Proton therapy (Intensity-modulated proton therapy [IMPT] preferred) is an acceptable treatment modality.~Stem Cell Radiotherapy (ScRT) and Temozolomide"
671433|NCT02039687|B5|Baseline|Total|Total of all reporting groups
671434|NCT02039687|B4|Baseline|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671435|NCT02039687|B3|Baseline|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671436|NCT02039687|B2|Baseline|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671437|NCT02039687|B1|Baseline|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671438|NCT02039687|P4|Participant Flow|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671439|NCT02039687|P3|Participant Flow|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671440|NCT02039687|P2|Participant Flow|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671441|NCT02039687|P1|Participant Flow|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671442|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671443|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671444|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671445|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671446|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671447|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671448|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671449|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671450|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671451|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671452|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671453|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671454|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671455|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671456|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671457|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671458|NCT02039687|O4|Outcome|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671459|NCT02039687|O3|Outcome|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671460|NCT02039687|O2|Outcome|4 mg Per Day ARA 290|"4 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671461|NCT02039687|O1|Outcome|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671462|NCT02039687|E4|Reported Event|Placebo|"1 mL placebo administered subcutaneously for 28 consecutive days~Placebo: Formulation buffer"
671463|NCT02039687|E3|Reported Event|8 mg Per Day ARA 290|"8 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671465|NCT02039687|E1|Reported Event|1 mg Per Day ARA 290|"1 mg ARA 290 administered subcutaneously for 28 consecutive days~ARA 290: A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms."
671466|NCT02039414|B3|Baseline|Total|Total of all reporting groups
671467|NCT02039414|B2|Baseline|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
671468|NCT02039414|B1|Baseline|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
671469|NCT02039414|P2|Participant Flow|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
671470|NCT02039414|P1|Participant Flow|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
671471|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
671472|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
671473|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
671474|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
671475|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
671476|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
671477|NCT02039414|O2|Outcome|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
671478|NCT02039414|O1|Outcome|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
671479|NCT02039414|E2|Reported Event|Obese, Active|Pregnant women with a BMI≥30kg/m2 and exercising >150min/week
671480|NCT02039414|E1|Reported Event|Obese, Inactive|Pregnant women with a BMI≥30kg/m2 and sedentary lifestyle
671481|NCT02038959|B3|Baseline|Total|Total of all reporting groups
671482|NCT02038959|B2|Baseline|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671483|NCT02038959|B1|Baseline|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671484|NCT02038959|P2|Participant Flow|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671485|NCT02038959|P1|Participant Flow|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671486|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671487|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671488|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
706545|NCT01813721|O2|Outcome|> 10 Years|
671489|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671490|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671491|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671492|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671493|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671494|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671495|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671496|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671497|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671498|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671548|NCT02038907|P12|Participant Flow|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671499|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671500|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671501|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671502|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671503|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671504|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671505|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671506|NCT02038959|O2|Outcome|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671507|NCT02038959|O1|Outcome|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671508|NCT02038959|E2|Reported Event|Virtual Visits and Educational Materials|"Participants with Parkinson disease randomized to the virtual visit intervention will receive educational materials from the National Parkinson Foundation, complete a baseline assessment and virtual study assessment with a physician independent rater, and then receive four virtual care visits with a Parkinson disease specialist in their state. Specialists will provide recommendations for care to participants and their designated local health care provider. At 12 months, these individuals will again be assessed by the independent rater, who will be blind to treatment assignment.~Virtual Visits: Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone)."
671576|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671509|NCT02038959|E1|Reported Event|Usual Care and Educational Materials|Participants with Parkinson disease will receive educational materials from the National Parkinson Foundation, complete a baseline assessment survey and virtual visit with a physician independent rater, then continue with their usual care in their communities for the duration of the study. After 12 months, they will have another virtual study assessment with an independent rater, after which they will receive a free, one-time virtual consultation with a Parkinson disease specialist in their state.
671510|NCT02038933|B3|Baseline|Total|Total of all reporting groups
671511|NCT02038933|B2|Baseline|ASCT-ineligible|Autologous stem cell transplant ineligible
671512|NCT02038933|B1|Baseline|ASCT-failed|Autologous stem cell transplant failed
671513|NCT02038933|P1|Participant Flow|Nivolumab 3mg/kg|Nivolumab 3mg/kg administered as an IV infusion on Treatment Day 1 of each 14 day cycle until disease progression or discontinuation due to toxicity, withdrawal of study consent, or the study ends.
671514|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671515|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671516|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671517|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671518|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671519|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671520|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671521|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671522|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671523|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671524|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671525|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671526|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671527|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671528|NCT02038933|O2|Outcome|ASCT-ineligible|Autologous stem cell transplant ineligible
671529|NCT02038933|O1|Outcome|ASCT-failed|Autologous stem cell transplant failed
671530|NCT02038933|E1|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3mg/kg administered as an IV infusion on Treatment Day 1 of each 14 day cycle until disease progression or discontinuation due to toxicity, withdrawal of study consent, or the study ends.
671531|NCT02038907|B15|Baseline|Total|Total of all reporting groups
671532|NCT02038907|B14|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671533|NCT02038907|B13|Baseline|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671534|NCT02038907|B12|Baseline|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671535|NCT02038907|B11|Baseline|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671536|NCT02038907|B10|Baseline|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671537|NCT02038907|B9|Baseline|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671538|NCT02038907|B8|Baseline|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671539|NCT02038907|B7|Baseline|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671540|NCT02038907|B6|Baseline|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671541|NCT02038907|B5|Baseline|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671542|NCT02038907|B4|Baseline|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671543|NCT02038907|B3|Baseline|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671544|NCT02038907|B2|Baseline|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671545|NCT02038907|B1|Baseline|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671546|NCT02038907|P14|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671547|NCT02038907|P13|Participant Flow|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
706546|NCT01813721|O1|Outcome|≤ 10 Years|
671549|NCT02038907|P11|Participant Flow|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671550|NCT02038907|P10|Participant Flow|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671551|NCT02038907|P9|Participant Flow|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671552|NCT02038907|P8|Participant Flow|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671553|NCT02038907|P7|Participant Flow|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671554|NCT02038907|P6|Participant Flow|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671555|NCT02038907|P5|Participant Flow|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671556|NCT02038907|P4|Participant Flow|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671557|NCT02038907|P3|Participant Flow|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671558|NCT02038907|P2|Participant Flow|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671559|NCT02038907|P1|Participant Flow|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671560|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671561|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671562|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671563|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671564|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671565|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671566|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671567|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671568|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671569|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671570|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671571|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671572|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671573|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671574|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671575|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671577|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671578|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671579|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671580|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671581|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671582|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671583|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671584|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671585|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671586|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671587|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671588|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671589|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671590|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671591|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671592|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671593|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671594|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671595|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671596|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671597|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671598|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671599|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671600|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671601|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671602|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671603|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672154|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
706547|NCT01813721|O2|Outcome|Hematologist|
671604|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671605|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671606|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671607|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671608|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671609|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671610|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671611|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671612|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671613|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671614|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671615|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671616|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671617|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671618|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671619|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671620|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671621|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671622|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671623|NCT02038907|O1|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671624|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671625|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671626|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671627|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671628|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671629|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671630|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672155|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
706548|NCT01813721|O1|Outcome|Medical Oncologist|
671631|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671632|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671633|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671634|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671635|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671636|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671637|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671638|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671639|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671640|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671641|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671642|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671643|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671644|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671645|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671646|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671647|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671648|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671649|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671650|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671651|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671652|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671653|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671654|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671655|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671656|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671657|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672156|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
671658|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671659|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671660|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671661|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671662|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671663|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671664|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671665|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671666|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671667|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671668|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671669|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671670|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671671|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671672|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671673|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671674|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671675|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671676|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671677|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671678|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671679|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671680|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671681|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671682|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671683|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671684|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672157|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
706549|NCT01813721|O4|Outcome|France|
671685|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671686|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671687|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671688|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671689|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671690|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671691|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671692|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671693|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671694|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671695|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671696|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671697|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671698|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671699|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671700|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671701|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671702|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671703|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671704|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671705|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671706|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671707|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671708|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671709|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671710|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671711|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
672158|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
706550|NCT01813721|O3|Outcome|Romania|
671712|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671713|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671714|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671715|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671716|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671717|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671718|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671719|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671720|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671721|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671722|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671723|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671724|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671725|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671726|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671727|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671728|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671729|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671730|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671731|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671732|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671733|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671734|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671735|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671736|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671737|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671738|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672159|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
706551|NCT01813721|O2|Outcome|Greece|
671739|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671740|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671741|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671742|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671743|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671744|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671745|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671746|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671747|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671748|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671749|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671750|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671751|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671752|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671753|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671754|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671755|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671756|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671757|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671758|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671759|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671760|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671761|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671762|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671763|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671764|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671765|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672160|NCT02037477|E4|Reported Event|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
671766|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671767|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671768|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671769|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671770|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671771|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671772|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671773|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671774|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671775|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671776|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671777|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671778|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671779|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671780|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671781|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671782|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671783|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671784|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671785|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671786|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671787|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671788|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671789|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671790|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671791|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671792|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672161|NCT02037477|E3|Reported Event|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
671793|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671794|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671795|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671796|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671797|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671798|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671799|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671800|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671801|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671802|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671803|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671804|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671805|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671806|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671807|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671808|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671809|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671810|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671811|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671812|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671813|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671814|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671815|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671816|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671817|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671818|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671819|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672162|NCT02037477|E2|Reported Event|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
671820|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671821|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671822|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671823|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671824|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671825|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671826|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671827|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671828|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671829|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671830|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671831|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671832|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671833|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671834|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671835|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671836|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671837|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671838|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671839|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671840|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671841|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671842|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671843|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671844|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671845|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671846|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672009|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671847|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671848|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671849|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671850|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671851|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671852|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671853|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671854|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671855|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671856|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671857|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671858|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671859|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671860|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671861|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671862|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671863|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671864|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671865|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671866|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671867|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671868|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671869|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671870|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671871|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671872|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671873|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672140|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
706552|NCT01813721|O1|Outcome|Poland|
671874|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671875|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671876|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671877|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671878|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671879|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671880|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671881|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671882|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671883|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671884|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671885|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671886|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671887|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671888|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671889|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671890|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671891|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671892|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671893|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671894|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671895|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671896|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671897|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671898|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671899|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671900|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672141|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
672212|NCT02036840|B1|Baseline|Penicillin Allergy|Antibiotic
671901|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671902|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671903|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671904|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671905|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671906|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671907|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671908|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671909|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671910|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671911|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671912|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671913|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671914|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671915|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671916|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671917|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671918|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671919|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671920|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671921|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671922|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671923|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671924|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671925|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671926|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671927|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672142|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
671928|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671929|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671930|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671931|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671932|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671933|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671934|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671935|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671936|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671937|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671938|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671939|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671940|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671941|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671942|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671943|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671944|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671945|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671946|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671947|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671948|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671949|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671950|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671951|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671952|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671953|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671954|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672143|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
671955|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671956|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671957|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671958|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671959|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671960|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671961|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671962|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671963|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671964|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671965|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671966|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671967|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671968|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671969|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671970|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671971|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671972|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671973|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671974|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671975|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671976|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671977|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671978|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671979|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671980|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671981|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672144|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
671982|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671983|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671984|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671985|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671986|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671987|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
671988|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671989|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671990|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
671991|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
671992|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671993|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671994|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671995|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
671996|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671997|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
671998|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
671999|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672000|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672001|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672002|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672003|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672004|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672005|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
672006|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672007|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672008|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672145|NCT02037477|O3|Outcome|Cohort 2 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
672010|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672011|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672012|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672013|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672014|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672015|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672016|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672017|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672018|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672019|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
672020|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672021|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672022|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672023|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672024|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672025|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672026|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672027|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672028|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672029|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672030|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672031|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672032|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672033|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
672034|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672035|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672036|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672146|NCT02037477|O2|Outcome|Cohort 1 - Esomeprazole 20 mg|Esomeprazole 20 mg, orally, once daily for 7 days.
672037|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672038|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672039|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672040|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672041|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672042|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672043|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672044|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672045|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672046|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672047|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
672048|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672049|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672050|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672051|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672052|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672053|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672054|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672055|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672056|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672057|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672058|NCT02038907|O14|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672059|NCT02038907|O13|Outcome|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672060|NCT02038907|O12|Outcome|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672061|NCT02038907|O11|Outcome|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
672062|NCT02038907|O10|Outcome|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672063|NCT02038907|O9|Outcome|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672147|NCT02037477|O1|Outcome|Cohort 1 - Vonoprazan 20 mg|Vonoprazan 20 mg, orally, once daily for 7 days.
672064|NCT02038907|O8|Outcome|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672065|NCT02038907|O7|Outcome|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672066|NCT02038907|O6|Outcome|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672067|NCT02038907|O5|Outcome|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672068|NCT02038907|O4|Outcome|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672069|NCT02038907|O3|Outcome|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672070|NCT02038907|O2|Outcome|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672071|NCT02038907|O1|Outcome|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672072|NCT02038907|E14|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672073|NCT02038907|E13|Reported Event|GI.1/GII.4 (50/150) x2|Norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672074|NCT02038907|E12|Reported Event|GI.1/GII.4 (15/50) x2|Norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 1 and Day 28.
672075|NCT02038907|E11|Reported Event|GI.1/GII.4 (15/50) - Al(OH)3 (167)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 167 µg aluminum hydroxide, IM, on Day 28.
672076|NCT02038907|E10|Reported Event|GI.1/GII.4 (50/150)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 150 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672077|NCT02038907|E9|Reported Event|GI.1/GII.4 (50/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672078|NCT02038907|E8|Reported Event|GI.1/GII.4 (15/50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672079|NCT02038907|E7|Reported Event|GI.1/GII.4 (15/15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 500 µg aluminum hydroxide, IM, on Day 28.
672080|NCT02038907|E6|Reported Event|GI.1/GII.4 (50/50) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672081|NCT02038907|E5|Reported Event|GI.1/GII.4 (15/50) - MPL (15)|IM hepatitis A vaccine on Day 1, followed by IM norovirus bivalent vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, on Day 28.
672082|NCT02038907|E4|Reported Event|GI.1/GII.4 (15/15) - MPL (15)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 15 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672083|NCT02038907|E3|Reported Event|GI.1/GII.4 (50/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (50 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672084|NCT02038907|E2|Reported Event|GI.1/GII.4 (15/50) - MPL (50)|Hepatitis A vaccine, IM, on Day 1, followed by norovirus bivalent VLP vaccine (15 µg of GI.1 norovirus VLP and 50 µg GII.4 norovirus VLP) adjuvanted with 50 µg MLP and 500 µg aluminum hydroxide, IM, on Day 28.
672085|NCT02038907|E1|Reported Event|GI.1/GII.4 (15/15) - MPL (50)|Hepatitis A vaccine, intramuscular (IM), on Day 1, followed by norovirus bivalent virus like particle (VLP) vaccine (15 µg of GI.1 norovirus virus VLP and 15 µg GII.4 norovirus VLP) adjuvanted with 50 µg monophosphoryl lipid A (MLP) and 500 µg aluminum hydroxide, IM on Day 28.
672086|NCT02038790|B1|Baseline|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
672087|NCT02038790|P2|Participant Flow|Zubsolv - Suboxone|Participants received Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 0 and Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 1.
672088|NCT02038790|P1|Participant Flow|Suboxone - Zubsolv|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1.
672089|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672090|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672091|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672092|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672093|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672094|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672095|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672096|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672097|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672098|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672099|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672100|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672101|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672102|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672103|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672104|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672105|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672106|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672107|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672108|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672109|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672110|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672111|NCT02038790|O2|Outcome|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672112|NCT02038790|O1|Outcome|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672113|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
672114|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
672115|NCT02038790|O1|Outcome|All Participants|Participants received Suboxone® (buprenorphine 8 mg /naloxone 2 mg sublingual film) on Day 0 and Zubsolv® (buprenorphine 5.7 mg /naloxone 1.4 mg sublingual tablet) on Day 1 or the reverse depending on randomized assignment.
672116|NCT02038790|E2|Reported Event|Zubsolv Sublingual Tablets 5.7/1.4|Participants took a single dose of Zubsolv sublingual tablets 5.7/1.4 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672117|NCT02038790|E1|Reported Event|Suboxone Sublingual Film 8/2|Participants took a single dose of Suboxone sublingual film 8/2 either on Day 0 or Day 1, depending on the how each participant was randomized in this cross-over study.
672118|NCT02038075|B3|Baseline|Total|Total of all reporting groups
672119|NCT02038075|B2|Baseline|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
672148|NCT02037477|O4|Outcome|Cohort 2 - Rabeprazole Sodium 10 mg|Rabeprazole sodium 10 mg, orally, once daily for 7 days.
672213|NCT02036840|P1|Participant Flow|Penicillin Allergy|Antibiotic
672120|NCT02038075|B1|Baseline|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
672121|NCT02038075|P2|Participant Flow|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
672122|NCT02038075|P1|Participant Flow|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
672123|NCT02038075|O2|Outcome|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
672124|NCT02038075|O1|Outcome|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
672125|NCT02038075|E2|Reported Event|Treatment As Usual (TAU)|"Participants in TAU receive usual care from military clinicians as well as non-military clinicians from the local community, as determined by participants' primary mental health care provider. All mental health, substance abuse, and medical treatment are provided within the military health care system at no cost to participants.~Treatment As Usual (TAU)"
672126|NCT02038075|E1|Reported Event|Brief Cognitive Behavioral Therapy (BCBT)|"In addition to TAU, participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.~Brief Cognitive Behavioral Therapy (BCBT)"
672127|NCT02037607|B1|Baseline|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound within 48 hours prior to surgery and a repeat within 72 hours after surgery.
672128|NCT02037607|P1|Participant Flow|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
672129|NCT02037607|O1|Outcome|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
672130|NCT02037607|E1|Reported Event|Ultrasound Group (All)|All subjects in the study are in the same group. Study procedure is ultrasound
672131|NCT02037477|B5|Baseline|Total|Total of all reporting groups
672132|NCT02037477|B4|Baseline|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
672133|NCT02037477|B3|Baseline|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
672134|NCT02037477|B2|Baseline|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
672135|NCT02037477|B1|Baseline|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
672136|NCT02037477|P4|Participant Flow|Sequence D (Cohort 2): Rabeprazole Sodium + Vonoprazan|Rabeprazole sodium 10 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
672137|NCT02037477|P3|Participant Flow|Sequence C (Cohort 2): Vonoprazan + Rabeprazole Sodium|Vonoprazan 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then rabeprazole sodium 10 mg, orally, once daily for 7 days.
672138|NCT02037477|P2|Participant Flow|Sequence B (Cohort 1): Esomeprazole + Vonoprazan|Esomeprazole 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then vonoprazan 20 mg, orally, once daily for 7 days.
672139|NCT02037477|P1|Participant Flow|Sequence A (Cohort 1): Vonoprazan + Esomeprazole|Vonoprazan (TAK-438) 20 mg, orally, once daily for 7 days, followed by a washout period of at least 7 days and then esomeprazole 20 mg, orally, once daily for 7 days.
672164|NCT02037425|B1|Baseline|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days). A total of 30 subjects were used in data analysis as 2 subjects did not complete any outcome measures once enrolled in the study.
672165|NCT02037425|P1|Participant Flow|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
672166|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672167|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672168|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672169|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672170|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672171|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672172|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672173|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672174|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672175|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672176|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672177|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672178|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672179|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672180|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672181|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672182|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672183|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672184|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672185|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672186|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672187|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672188|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672189|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672190|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672191|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672192|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672193|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672194|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672195|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672196|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672197|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672198|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672199|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672200|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672201|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672202|NCT02037425|O3|Outcome|Group C|Subjects reporting no or minimal of benefit from onabotuliunumtoxinA (3 weeks or less).
672203|NCT02037425|O2|Outcome|Group B|Subjects reporting greater than 10 weeks of benefit from onabotuliunumtoxinA.
672204|NCT02037425|O1|Outcome|Group A|Subjects reporting 10 weeks or less of benefit from onabotuliunumtoxinA.
672205|NCT02037425|E1|Reported Event|onabotulinumtoxinA|At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
672206|NCT02037347|B1|Baseline|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
672207|NCT02037347|P1|Participant Flow|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
672208|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
672209|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
672210|NCT02037347|O1|Outcome|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
672211|NCT02037347|E1|Reported Event|Palifermin|Palifermin 60 micrograms/kg/day IV for 3 consecutive days
672300|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
672216|NCT02036775|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~Each subject received one treatment per treatment period. Each of the three treatment phases was 6 days long, where study drug was administered on day 1-5 during each treatment."
672217|NCT02036775|P6|Participant Flow|Lasolvan 75mg / Lasolvan 60mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
672218|NCT02036775|P5|Participant Flow|Lasolvan 30mg / Lasolvan 75mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
672219|NCT02036775|P4|Participant Flow|Lasolvan 60mg / Lasolvan 30mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
672220|NCT02036775|P3|Participant Flow|Lasolvan 30mg / Lasolvan 60mg / Lasolvan 75mg|"Patients were administered three treatments in the following order:~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days"
672221|NCT02036775|P2|Participant Flow|Lasolvan 60mg / Lasolvan 75mg / Lasolvan 30mg|"Patients were administered three treatments in the following order:~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)"
672222|NCT02036775|P1|Participant Flow|Lasolvan 75mg / Lasolvan 30mg / Lasolvan 60mg|"Patients were administered three treatments in the following order:~One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days~One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)~One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days"
672223|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672224|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672225|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672226|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672227|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672228|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672229|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672230|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672231|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672232|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672233|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672234|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672235|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672236|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672237|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672238|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672239|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672240|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672241|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672242|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672243|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672244|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672245|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672247|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672248|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672249|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672250|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672251|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672252|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672253|NCT02036775|O3|Outcome|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672254|NCT02036775|O2|Outcome|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672255|NCT02036775|O1|Outcome|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672256|NCT02036775|E3|Reported Event|Lasolvan 30mg|One Lasolvan tablet, 30mg, was taken with 200mL of boiled water twice daily for 5 days (reference treatment)
672257|NCT02036775|E2|Reported Event|Lasolvan 60mg|One-half Lasolvan effervescent tablet, 60mg, dissolved in 200mL of boiled water, taken twice daily for 5 days
672258|NCT02036775|E1|Reported Event|Lasolvan 75mg|One Lasolvan prolonged release hard capsule, 75mg, swallowed and taken with 200ml of boiled water once daily for 5 days
672259|NCT02036580|B4|Baseline|Total|Total of all reporting groups
672260|NCT02036580|B3|Baseline|Placebo|Placebo Q4W intravenously dosed for 24 weeks
672261|NCT02036580|B2|Baseline|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
672262|NCT02036580|B1|Baseline|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
672263|NCT02036580|P3|Participant Flow|Placebo|Placebo Q4W intravenously dosed for 24 weeks
672264|NCT02036580|P2|Participant Flow|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
672265|NCT02036580|P1|Participant Flow|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
672266|NCT02036580|O3|Outcome|Placebo|Placebo Q4W intravenously dosed for 24 weeks
672267|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
672268|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
672269|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
672270|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
672271|NCT02036580|O3|Outcome|Placebo|Placebo Q4W intravenously dosed for 24 weeks
672272|NCT02036580|O2|Outcome|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
672273|NCT02036580|O1|Outcome|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
672274|NCT02036580|E3|Reported Event|Placebo|Placebo Q4W intravenously dosed for 24 weeks
672275|NCT02036580|E2|Reported Event|High Dose|Tralokinumab 800 mg Q4W intravenously dosed for 24 weeks
672276|NCT02036580|E1|Reported Event|Low Dose|Tralokinumab 400 mg Q4W intravenously dosed for 24 weeks
672277|NCT02036541|B1|Baseline|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
672278|NCT02036541|P1|Participant Flow|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
672279|NCT02036541|O1|Outcome|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
672280|NCT02036541|O1|Outcome|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
672281|NCT02036541|E1|Reported Event|XEN 45 Gel Stent|Placement of the XEN 45 Gel Stent in the study eye
672282|NCT02036424|B3|Baseline|Total|Total of all reporting groups
672283|NCT02036424|B2|Baseline|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
672284|NCT02036424|B1|Baseline|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
672285|NCT02036424|P2|Participant Flow|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
672286|NCT02036424|P1|Participant Flow|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
672287|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
672288|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
672289|NCT02036424|O2|Outcome|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
672290|NCT02036424|O1|Outcome|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
672291|NCT02036424|E2|Reported Event|Ozurdex|"Dexamethasone intravitreal implant, 0.7 mg given every 3 months over 6 month period with a maximum of 3 injections~Ozurdex: intravitreal steroid"
672292|NCT02036424|E1|Reported Event|Bevacizumab|"1.25 mg intravitreal injection given monthly during a 6 month period~Bevacizumab: antiVEGF"
672293|NCT02036320|B1|Baseline|Overall|All subjects that were dispensed a test article during the study.
672294|NCT02036320|P2|Participant Flow|Test 2/Test 1|Subjects who received test lens 2 first and then received test lens 1.
672295|NCT02036320|P1|Participant Flow|Test 1/Test 2|Subjects who received test lens 1 first and then received test lens 2.
672296|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
672297|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
672298|NCT02036320|O2|Outcome|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
672299|NCT02036320|O1|Outcome|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
672302|NCT02036320|E2|Reported Event|Test 2|Subjects that received Test lens 2 during the first or second period of the study.
672303|NCT02036320|E1|Reported Event|Test 1|Subjects that received Test lens 1 during the first or second period of the study.
672304|NCT02035748|B1|Baseline|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672305|NCT02035748|P1|Participant Flow|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672306|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672307|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672308|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672309|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672310|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672311|NCT02035748|O1|Outcome|Ocriplasmin|Ocriplasmin 0.125 mg in a 0.1 mL volume administered as a single dose by intravitreal injection
672312|NCT02035748|E2|Reported Event|Ocriplasmin|All subjects exposed to the investigational product
672313|NCT02035748|E1|Reported Event|Pretreatment|All subjects consented to participate in the study prior to the initiation of study treatment
672314|NCT02035475|B1|Baseline|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
672315|NCT02035475|P1|Participant Flow|Intuitive Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
672316|NCT02035475|O1|Outcome|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
672317|NCT02035475|O2|Outcome|Fenestrated Maryland BiPolar Instrument|The Fenestrated Maryland BiPolar Instrument was utilized on one side of the body, with each participant receiving both treatments, one each side.
672318|NCT02035475|O1|Outcome|EndoWrist 1 Vessel Sealer|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~The EndoWrist 1 Vessel Sealer was utilized on one side of the body, with each participant receiving both treatments, one each side."
672319|NCT02035475|E1|Reported Event|Study Participants|"Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.~Intuitive Vessel Sealer: Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control."
672320|NCT02035345|B1|Baseline|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
672321|NCT02035345|P1|Participant Flow|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
672322|NCT02035345|O1|Outcome|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
672323|NCT02035345|O1|Outcome|Carboplain Slowed Infusion Group Reactors|Patients that received carboplatin via slowed infusion that developed a reaction
672324|NCT02035345|E1|Reported Event|Carboplatin|"Carboplatin will be prepared as a single 500ml infusion. Potentially 6 cycles Carboplatin (Amount of total dose) will be administered intravenously by the treating nurse according to the following schedule:~First hour - Administer 1 percent of total dose (5ml with tubing primed)~Second hour - Administer 9 percent (45 mL)~Third hour - Administer 90 percent (450 mL)~Carboplatin"
672325|NCT02035332|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672326|NCT02035332|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672327|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672328|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672329|NCT02035332|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672330|NCT02035332|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672331|NCT02034877|B3|Baseline|Total|Total of all reporting groups
672332|NCT02034877|B2|Baseline|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672333|NCT02034877|B1|Baseline|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672334|NCT02034877|P2|Participant Flow|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672335|NCT02034877|P1|Participant Flow|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672336|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672337|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672338|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672339|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672340|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672341|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672342|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672343|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672344|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672345|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672346|NCT02034877|O2|Outcome|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672347|NCT02034877|O1|Outcome|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672348|NCT02034877|E2|Reported Event|13vPnC (Adult Participants)|Adult participants aged 50 to 65 years received 1 single 0.5 mL dose of 13vPnC intramuscularly.
672349|NCT02034877|E1|Reported Event|13vPnC (Pediatric Participants)|Pediatric participants aged 6 to 17 years received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly.
672350|NCT02034708|B3|Baseline|Total|Total of all reporting groups
672351|NCT02034708|B2|Baseline|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
672352|NCT02034708|B1|Baseline|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
672353|NCT02034708|P2|Participant Flow|Gadovist®/Dotarem®|"Gadovist®/Gadavist®-enhanced MRI then Dotarem® enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
672354|NCT02034708|P1|Participant Flow|Dotarem®/Gadovist®|"Dotarem®-enhanced MRI, then Gadovist®/Gadavist®-enhanced MRI~Dotarem®: 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.~Gadovist®/Gadavist®: 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus."
672355|NCT02034708|O6|Outcome|Dotarem® (Reader 3)|Patients who received Dotarem® Results for reader 3
672356|NCT02034708|O5|Outcome|Gadovist® (Reader 3)|Patients who received Gadovist® Results for reader 3
672357|NCT02034708|O4|Outcome|Dotarem® (Reader 2)|Patients who received Dotarem® Results for reader 2
672358|NCT02034708|O3|Outcome|Gadovist® (Reader 2)|Patients who received Gadovist® Results for reader 2
672359|NCT02034708|O2|Outcome|Dotarem® (Reader 1)|Patients who received Dotarem® Results for reader 1
672360|NCT02034708|O1|Outcome|Gadovist® (Reader 1)|Patients who received Gadovist® Results for reader 1
672361|NCT02034708|E3|Reported Event|Total|Patients who received at least one injection of contrast agent
672362|NCT02034708|E2|Reported Event|Gadovist®|Patients who received Gadovist®
672363|NCT02034708|E1|Reported Event|Dotarem®|Patients who received Dotarem®
672364|NCT02034591|B1|Baseline|All Treatment Groups|All Randomized Participants
672365|NCT02034591|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
672366|NCT02034591|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
672367|NCT02034591|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
672408|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
672409|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
677633|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
672368|NCT02034591|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
672369|NCT02034591|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
672370|NCT02034591|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Each participant was given three interventions, one per period, with a 4 day washout in between periods~Treatment A: Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe~Treatment B: Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT~Treatment C: Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT"
672371|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
672372|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
672373|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672374|NCT02034591|O3|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
672375|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
672376|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672377|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
672378|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672379|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
672380|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672381|NCT02034591|O2|Outcome|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
672382|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672383|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
672384|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672385|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
672386|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672387|NCT02034591|O2|Outcome|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
672388|NCT02034591|O1|Outcome|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672389|NCT02034591|E3|Reported Event|Treatment C|Single dose apixaban 5 mg (5 mg tablet crushed and suspended in 60 mL 5% dextrose in water (D5W) administered via NGT
672390|NCT02034591|E2|Reported Event|Treatment B|Single dose apixaban 5 mg OS (0.4 mg/mL x 12.5 mL) administered via nasogastric tube (NGT) after 180 mL of Boost® Plus, followed by 60 mL of Boost® Plus via same NGT
672391|NCT02034591|E1|Reported Event|Treatment A|Single dose apixaban 5 milligrams (mg) oral solution (OS) (0.4 milligrams per milliliter (mg/mL) x 12.5 milliliters (mL) administered by mouth via oral syringe
672392|NCT02034578|B1|Baseline|5mg Apixaban|After a 10 hour fast, participants were randomized to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) administered over 3 periods. Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in the next period.
672405|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
672406|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
672407|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
706553|NCT01813721|O1|Outcome|Primary Analysis Set|
672393|NCT02034578|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
672394|NCT02034578|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
672395|NCT02034578|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
672396|NCT02034578|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
672397|NCT02034578|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
672398|NCT02034578|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|"Treatment A: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered by mouth via oral syringe.~Treatment B: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via a Nasogastric tube (NGT) immediately followed by 60 mL of dextrose 5% in water (D5W) via NGT.~Treatment C: Single dose apixaban 5 mg (0.4 mg/mL oral solution x 12.5 mL) administered via an NGT immediately followed by 60 mL of infant formula via NGT.~After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences across 3 periods(ABC, ACB, BAC, BCA, CAB or CBA). Fasted participants received a single dose of apixaban 5 mg on Day 1 of Periods 1, 2, and 3. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3."
672399|NCT02034578|O1|Outcome|5mg Apixaban|After a 10 hour fast, participants were randomized on Day 1 of Period 1 to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. Treatment A was administered via oral syringe, Treatment B was administered via an NGT followed by 60 mL of D5W via an NGT, and Treatment C was administered via an NGT, followed by 60 mL of infant formula via an NGT. There was at least a 4 day washout before receiving the next scheduled treatment in Period 2 and Period 3.
672400|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
672401|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
672402|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
672403|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
672404|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
672410|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
672411|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
672412|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
672413|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
672414|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
672415|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
672416|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
672417|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
672418|NCT02034578|O3|Outcome|5 mg Apixaban Via NGT Followed by Infant Formula (C)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of infant formula via NGT
672419|NCT02034578|O2|Outcome|5mg Apixaban Via NGT Followed by D5W (B)|Single dose Apixaban 5 mg oral solution via NGT immediately followed by 60 mL of D5W via NGT
672420|NCT02034578|O1|Outcome|5mg Apixaban Via Oral Syringe (A)|Single dose Apixaban 5 mg oral solution via oral syringe
672421|NCT02034578|E3|Reported Event|5 mg Apixaban Via NGT Followed by Infant Formula (C)|In Treatment C, the single dose of 5 mg apixaban was administered via NGT, followed by 60 mL of infant formula via the NGT.
672422|NCT02034578|E2|Reported Event|5mg Apixaban Via NGT Followed by D5W (B)|In Treatment B the single dose of 5 mg apixaban was administered via nasogastric tube (NGT) followed by 60 mL of dextrose, water (D5W) via the NGT.
672423|NCT02034578|E1|Reported Event|5mg Apixaban Via Oral Syringe (A)|"After a 10 hour fast, on Day 1 of Period 1, participants were randomized to one of six treatment sequences administered over 3 Periods (ABC, ACB, BAC, BCA, CAB or CBA) and received a single dose of apixaban 5 mg. After participants received the Period 1 dose, there was ≥4-days of washout before their Period 2, Day 1 dose was administered, which was followed by another ≥4-days of washout. After their Period 3, Day 1 dose, participants were discharged on Day 4 of Period 3.~In Treatment A the single dose of 5 mg apixaban was administered via oral syringe."
672424|NCT02034565|B1|Baseline|All Treatment Groups|All Randomized Participants
672425|NCT02034565|P2|Participant Flow|Treatment B, Then Treatment A|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
672426|NCT02034565|P1|Participant Flow|Treatment A, Then Treatment B|"Each participant was given two interventions, one per period, with a 4 day washout in between periods.~Treatment A: Single dose apixaban film-coated tablet, 10 milligrams (mg) via 2 x 5 mg tablets, administered orally~Treatment B: Single dose apixaban solution, 10 milligrams (mg) via 25 milliliters (mL) x 0.4 mg/mL, administered orally"
672427|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
672428|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
672429|NCT02034565|O2|Outcome|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
672430|NCT02034565|O1|Outcome|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
672431|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
672432|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
672433|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
672434|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
672435|NCT02034565|O2|Outcome|Treatment B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
672436|NCT02034565|O1|Outcome|Treatment A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
672437|NCT02034565|E2|Reported Event|Arm B: Apixaban Oral Solution|Single dose apixaban 10 mg (solution) administered orally
672438|NCT02034565|E1|Reported Event|Arm A: Apixaban Tablet|Single dose apixaban 10 mg (film-coated tablet) administered orally
672439|NCT02034513|B3|Baseline|Total|Total of all reporting groups
672440|NCT02034513|B2|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672486|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672487|NCT02034162|E3|Reported Event|OL Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
672802|NCT02032407|P1|Participant Flow|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672488|NCT02034162|E2|Reported Event|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
709744|NCT01791725|E2|Reported Event|ELND005 QD|"ELND005 250 mg QD~ELND005"
672441|NCT02034513|B1|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
672442|NCT02034513|P2|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672443|NCT02034513|P1|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered subcutaneously (s.c.; under the skin) in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken once daily (OD) at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast self measured plasma glucose(SMPG) values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L)
672444|NCT02034513|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672445|NCT02034513|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
672446|NCT02034513|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672447|NCT02034513|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
672448|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672449|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672450|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672451|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672452|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672453|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672454|NCT02034513|O2|Outcome|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672455|NCT02034513|O1|Outcome|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672456|NCT02034513|E2|Reported Event|Insulin Glargine (IGlar)|Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672457|NCT02034513|E1|Reported Event|Insulin Degludec (IDeg)|Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
672458|NCT02034162|B3|Baseline|Total|Total of all reporting groups
672459|NCT02034162|B2|Baseline|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672460|NCT02034162|B1|Baseline|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672461|NCT02034162|P3|Participant Flow|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
672462|NCT02034162|P2|Participant Flow|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672463|NCT02034162|P1|Participant Flow|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672464|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
672465|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
672466|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
672467|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
672468|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
672469|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
672470|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
672471|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
672472|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
672473|NCT02034162|O1|Outcome|Open-label Mebendazole 500 mg|Mebendazole 500-mg chewable tablet was administered in an open label manner at visit 3 (Day 19+/-2) followed up to Visit 5 (Day 7+/-1 from Visit 3).
672474|NCT02034162|O3|Outcome|Mebendazole: Group 3 (7 to 16 Years)|Group 3 represents pharmacokinetic analysis set which included participants with age group 7 to 16 years and received Mebendazole 500 mg.
672475|NCT02034162|O2|Outcome|Mebendazole: Group 2 (3 to 6 Years)|Group 2 represents pharmacokinetic analysis set which included participants with age group 3 to 6 years and received Mebendazole 500 mg.
672476|NCT02034162|O1|Outcome|Mebendazole: Group 1 (1 to <3 Years)|Group 1 represents pharmacokinetic analysis set which included participants with age group 1 to less than (<) 3 years and received Mebendazole 500 milligram (mg).
672477|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672478|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672479|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672480|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672481|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672482|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672483|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672484|NCT02034162|O1|Outcome|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672485|NCT02034162|O2|Outcome|Double-blind Mebendazole 500 mg|Experimental: Mebendazole. Mebendazole was administered as a single 500-mg chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672489|NCT02034162|E1|Reported Event|Double-blind Placebo|Placebo Comparator: Placebo. Matching placebo was administered as a single-dose chewable tablet in a double-blind manner at the baseline visit (Day 1) followed up to Visit 3 (Day 19+/-2).
672490|NCT02033317|B1|Baseline|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
672491|NCT02033317|P1|Participant Flow|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
672492|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
672493|NCT02033317|O1|Outcome|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally
672494|NCT02033317|E1|Reported Event|Patiromer|15 grams/day (5 grams 3 times daily) patiromer administered orally.
672495|NCT02033213|B3|Baseline|Total|Total of all reporting groups
672496|NCT02033213|B2|Baseline|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672497|NCT02033213|B1|Baseline|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672498|NCT02033213|P2|Participant Flow|Liberal Group|"Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672499|NCT02033213|P1|Participant Flow|Restrictive Group|"Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672500|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672501|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672502|NCT02033213|O2|Outcome|Liberal Group|"Patients who received > 8 ml/kg/h of fluid. A fluid used during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Liberal group: A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672503|NCT02033213|O1|Outcome|Restrictive Group|"Patients who received ≤ 8ml/kg/h of intraoperative fluid. A fluid administered during surgery: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells.~Restrictive group: A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672504|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672505|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672506|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672507|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672803|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
706554|NCT01813721|O2|Outcome|General Hospital|
672570|NCT02032888|B2|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
672508|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672509|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672510|NCT02033213|O2|Outcome|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672511|NCT02033213|O1|Outcome|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672512|NCT02033213|E2|Reported Event|Liberal Group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672513|NCT02033213|E1|Reported Event|Restrictive Group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
672514|NCT02033200|B3|Baseline|Total|Total of all reporting groups
672515|NCT02033200|B2|Baseline|Placebo|placebo
672516|NCT02033200|B1|Baseline|Active|Stendra 200 mg
672517|NCT02033200|P2|Participant Flow|Placebo|placebo
672518|NCT02033200|P1|Participant Flow|Active|Stendra 200 mg
672519|NCT02033200|O2|Outcome|Placebo|placebo
672520|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672521|NCT02033200|O2|Outcome|Placebo|placebo
672522|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672523|NCT02033200|O2|Outcome|Placebo|placebo
672524|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672525|NCT02033200|O2|Outcome|Placebo|placebo
672526|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672527|NCT02033200|O2|Outcome|Placebo|placebo
672528|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672529|NCT02033200|O2|Outcome|Placebo|placebo
672530|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672531|NCT02033200|O2|Outcome|Placebo|placebo
672532|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672533|NCT02033200|O2|Outcome|Placebo|placebo
672534|NCT02033200|O1|Outcome|Active|Stendra 200 mg
672535|NCT02033200|E2|Reported Event|Placebo|placebo
672536|NCT02033200|E1|Reported Event|Active|Stendra 200 mg
672537|NCT02033174|B1|Baseline|All Participants|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
672538|NCT02033174|P2|Participant Flow|Sugar Water First ,Then Alcohol|Participants first received an oral fat-enriched diet (1486 kcal/m2) and sugar with water for 5 days. They then received a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days.
672539|NCT02033174|P1|Participant Flow|Alcohol First, Then Sugar Water|Participants first received an oral fat-enriched diet (1486 kcal/m2) and a daily total amount of 16 g/m2 of alcohol, of different beverages (red wine, vodka, brandy or rum) for 5 days. Then, they received equivalent caloric intakes as sugar with water in the control group for 5 days.
672540|NCT02033174|O2|Outcome|Oral Fat Diet|The fat-enriched diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
672541|NCT02033174|O1|Outcome|Alcoholic Beverages (Red Wine Intake)|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine
672542|NCT02033174|E2|Reported Event|Oral Fat Diet|Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat.
672543|NCT02033174|E1|Reported Event|Alcoholic Beverages|Cross over study over five different weeks. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
672544|NCT02032901|B3|Baseline|Total|Total of all reporting groups
672545|NCT02032901|B2|Baseline|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672546|NCT02032901|B1|Baseline|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672547|NCT02032901|P2|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672804|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
676590|NCT02004847|O1|Outcome|Low Intensity|PSO-CT02 device: Light wavelength 453nm, low intensity
672548|NCT02032901|P1|Participant Flow|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672549|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672550|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672551|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672552|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672553|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672554|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672555|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672556|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672557|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672558|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672559|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672560|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with HCV genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672561|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672562|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672563|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672564|NCT02032901|O2|Outcome|Daclatasvir + Sofosbuvir in Treatment-experienced Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and previously exposed to an interferon formulation or sofosbuvir /ribavirin or any other anti-HCV agents therapy, received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672565|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672566|NCT02032901|O1|Outcome|Daclatasvir + Sofosbuvir in Treatment-naive Participants|Participants infected with hepatitis C virus (HCV) genotype-3 and not exposed to an interferon formulation or ribavirin or any other HCV-specific direct-acting antiviral therapy, received daclatasvir 60-mg and sofosbuvir 400-mg tablets orally once daily for 12 weeks.
672567|NCT02032901|E1|Reported Event|Daclatasvir + Sofosbuvir|All participants infected with hepatitis C virus (HCV) genotype-3 received daclatasvir 60-mg tablets and sofosbuvir 400-mg tablets orally once daily for 12 weeks during the study.
672568|NCT02032888|B4|Baseline|Total|Total of all reporting groups
672569|NCT02032888|B3|Baseline|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672571|NCT02032888|B1|Baseline|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672572|NCT02032888|P3|Participant Flow|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672573|NCT02032888|P2|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
672574|NCT02032888|P1|Participant Flow|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily, for 12 weeks of treatment and 24 weeks of follow-up.
672575|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672576|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
672577|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672578|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672579|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
672580|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672581|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672582|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
672583|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672584|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvi,r 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672585|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
672586|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV) treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672587|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672588|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
672589|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672590|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672591|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
672592|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672593|NCT02032888|O3|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672594|NCT02032888|O2|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior HCV treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
672595|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus (HCV)treatment received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672596|NCT02032888|O1|Outcome|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672597|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 8 weeks of treatment and 24 weeks of follow-up.
672805|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672598|NCT02032888|O1|Outcome|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir, 60 mg, and sofosbuvir, 400 mg, once daily for 12 weeks of treatment and 24 weeks of follow-up.
672599|NCT02032888|E3|Reported Event|Treatment-experienced: Daclatasvir + Sofosbuvir 12 Weeks|Participants with prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672600|NCT02032888|E2|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 8 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 8 weeks of treatment and 24 weeks of follow-up.
672601|NCT02032888|E1|Reported Event|Treatment-naive: Daclatasvir + Sofosbuvir 12 Weeks|Participants without prior hepatitis C virus treatment, received daclatasvir 60-mg and sofosbuvir 400-mg OD orally, for 12 weeks of treatment and 24 weeks of follow-up.
672602|NCT02032875|B3|Baseline|Total|Total of all reporting groups
672603|NCT02032875|B2|Baseline|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672604|NCT02032875|B1|Baseline|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672605|NCT02032875|P2|Participant Flow|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672606|NCT02032875|P1|Participant Flow|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672607|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672608|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672609|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672610|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672611|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672612|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672613|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672614|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672615|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672616|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672617|NCT02032875|O2|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672618|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672619|NCT02032875|O1|Outcome|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
706555|NCT01813721|O1|Outcome|University Hospital|
672810|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672811|NCT02032407|E1|Reported Event|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672620|NCT02032875|O1|Outcome|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672621|NCT02032875|E2|Reported Event|Cirrhotic Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672622|NCT02032875|E1|Reported Event|Post-liver Transplant Cohort: Daclatasvir+Sofosbuvir+Ribavirin|Participants with liver transplant, received 12 weeks of daclatasvir 60-mg and sofosbuvir 400-mg once daily (QD) orally, with ribavirin at a recommended initial dose of 600 mg and were followed for 24 weeks post-treatment. The dose of ribavirin could be titrated to 1000 mg/day if tolerated.
672623|NCT02032758|B3|Baseline|Total|Total of all reporting groups
672624|NCT02032758|B2|Baseline|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
672625|NCT02032758|B1|Baseline|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
672626|NCT02032758|P2|Participant Flow|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
672627|NCT02032758|P1|Participant Flow|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
672628|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
672629|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
672630|NCT02032758|O2|Outcome|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
672631|NCT02032758|O1|Outcome|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
672632|NCT02032758|E2|Reported Event|Golf Pros|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting. The subjects in this arm will not receive any study drug.
672633|NCT02032758|E1|Reported Event|Golfers With Golfer's Cramp|Subjects in this arm will be tested with the Opal device, the Science and Motion PuttLab (SAM), and the Surface Electromyography (EMG) to collect movement parameters while putting before and after a single dose of 10 mg Propranolol.
672634|NCT02032706|B1|Baseline|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672635|NCT02032706|P1|Participant Flow|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672636|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672637|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672638|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672639|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672640|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672641|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672642|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672643|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672644|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672645|NCT02032706|O1|Outcome|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672646|NCT02032706|E1|Reported Event|Positional Feedback|"Deliver therapy when the supine position is detected~Deliver therapy when the supine position is detected: Application of vibrotactile feedback to the neck when the supine position is detected"
672647|NCT02032641|B1|Baseline|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
672648|NCT02032641|P1|Participant Flow|Laser Treatment and Control Group|"Each patient was randomized to have one of two scars treated with Laser Genesis and a scar not treated with Laser Genesis, which was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study. The laser treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage.~Laser treatment: Non-ablative, non-fractional, microsecond-pulsed Neodymium:Yttrium/Aluminum/Garnet laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size"
672649|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
672650|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
672651|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
672652|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
672653|NCT02032641|O2|Outcome|Control Scar|Each patient had a scar which was randomized to not undergo treatments with Laser Genesis, and was used as a control. Patients were not allowed to undergo laser or any other scar treatments with the exception of sun protection for the control scar for the duration of the study.
672654|NCT02032641|O1|Outcome|Laser Treatment Side|"Each patient was randomized to have one of two scars treated with Laser Genesis. The treatment was administered by manually scanning the rapidly pulsed laser in an even, painting motion throughout the entire treatment zone. The eyebrow hairs were covered with white tape to prevent inadvertent alopecia. The laser handpiece was oriented perpendicular to the skin at all times, at a distance of 1-2 cm. Patients were instructed throughout to give verbal feedback regarding if the area was too hot as an additional safeguard against epidermal damage."
672655|NCT02032641|E2|Reported Event|Laser Left, Non-laser RIght|Group which had the right post-operative scar assigned to receive laser treatment
672656|NCT02032641|E1|Reported Event|Laser Right, Non-laser Left|Group which had the right post-operative scar assigned to receive laser treatment
672657|NCT02031471|B1|Baseline|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672658|NCT02031471|P1|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. Participants entered 8 weeks of follow-up either at the end of the 24-week open-label core study or after completion of the LTE. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
672659|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672660|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672661|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672806|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672807|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672662|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672663|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672664|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672665|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672666|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672667|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672668|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672669|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672670|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672671|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672672|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672673|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672674|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672675|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672676|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672677|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672678|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672679|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672808|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672680|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672681|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672682|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672683|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672684|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672685|NCT02031471|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the LTE period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 mg tocilizumab was administered subcutaneously once weekly.
672686|NCT02031471|E1|Reported Event|Tocilizumab|Adults with rheumatoid arthritis received a fixed dose of tocilizumab during the 24-week open-label core study and those entering the long term extension (LTE) period further received a fixed dose up to a maximum of 28 weeks or until tocilizumab was commercially available and/or reimbursed whichever came first. A fixed dose of 162 milligram (mg) tocilizumab was administered subcutaneously once weekly.
672687|NCT02031458|B4|Baseline|Total|Total of all reporting groups
672688|NCT02031458|B3|Baseline|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672689|NCT02031458|B2|Baseline|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672690|NCT02031458|B1|Baseline|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672691|NCT02031458|P3|Participant Flow|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672692|NCT02031458|P2|Participant Flow|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in Eastern Cooperative Oncology Group (ECOG) performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672693|NCT02031458|P1|Participant Flow|Cohort 1: First Line Atezolizumab|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672694|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672734|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672695|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672696|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672697|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672698|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672699|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672700|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672701|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672702|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672703|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672704|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672705|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672706|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672707|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672735|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
706556|NCT01813721|O2|Outcome|> 10 Years|
672708|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672709|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672710|NCT02031458|O1|Outcome|Pharmacokinetic Evaluable Population|Participants received 1200 milligrams (mg) atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by intravenous (IV) infusion until intolerable toxicity, disease progression or death. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672711|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672712|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672713|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672714|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672715|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672716|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672717|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672718|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672719|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672720|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672762|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672763|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672809|NCT02032407|O1|Outcome|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672721|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672722|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672723|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672724|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672725|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672726|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672727|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672728|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672729|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672730|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672731|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672732|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672733|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672797|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
672736|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672737|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672738|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672739|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672740|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672741|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672742|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672743|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672744|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672745|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672746|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672747|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672748|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672798|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
706557|NCT01813721|O1|Outcome|≤ 10 Years|
672749|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672750|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672751|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672752|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672753|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672754|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672755|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672756|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672757|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672758|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672759|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672760|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672761|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672799|NCT02032420|E2|Reported Event|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
672764|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672765|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672766|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672767|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672768|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672769|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672770|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672771|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672772|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672773|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672774|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672775|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672776|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672800|NCT02032420|E1|Reported Event|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
706558|NCT01813721|O1|Outcome|Medical Oncologist|
672777|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672778|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672779|NCT02031458|O4|Outcome|Cohorts 2 + 3|This sub-group included participants from cohorts 2 and 3. All participants who were treated and had evaluable pharmacokinetic samples were included in this group.
672780|NCT02031458|O3|Outcome|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672781|NCT02031458|O2|Outcome|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672782|NCT02031458|O1|Outcome|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672783|NCT02031458|E3|Reported Event|Cohort 3: Third Line and Beyond Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks ( Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy and at least one additional therapy in locally advanced or metastatic setting.
672784|NCT02031458|E2|Reported Event|Cohort 2: Second Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21-day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants were permitted to continue treatment after progressive disease, if the following criteria were met: evidence of clinical benefit as assessed by the investigator; absence of symptoms and signs indicating unequivocal progression of disease; no decline in ECOG performance status; absence of tumor growth at critical anatomical sites that cannot be managed by protocol-allowed medical interventions; evidence of clinical benefit as assessed by the investigator. Participants in this cohort progressed during or after prior platinum-based chemotherapy in locally advanced or metastatic setting.
672785|NCT02031458|E1|Reported Event|Cohort 1: First Line Atezolizumab|Participants received 1200 mg atezolizumab every 3 weeks (Day 1 of 21 day cycle) administered by IV infusion until intolerable toxicity, disease progression or death. Participants in this cohort received no prior chemotherapy in locally advanced or metastatic setting.
672786|NCT02032420|B3|Baseline|Total|Total of all reporting groups
672787|NCT02032420|B2|Baseline|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
672788|NCT02032420|B1|Baseline|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
672789|NCT02032420|P2|Participant Flow|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
672790|NCT02032420|P1|Participant Flow|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
672791|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
672792|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
672793|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
672794|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
672795|NCT02032420|O2|Outcome|ART Strategy|Introductory training with a video depicting 3 probe position aspects for reacquisition of needle image by ultrasound: alignment, rotation, tilt.
672796|NCT02032420|O1|Outcome|STAR Strategy|Introductory training by video depicting 4 sequential maneuvers for reacquisition of needle image in ultrasound: see, tilt, align, rotate.
672801|NCT02032407|B1|Baseline|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
672813|NCT02032212|B4|Baseline|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the Nicotine inhalator on Day 2, the flavoured EVP on Day 3, the unflavoured EVP on Day 4.
672814|NCT02032212|B3|Baseline|Sequence 3|Subjects in this arm used the Nicotine inhalator on Day 1 and the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
672815|NCT02032212|B2|Baseline|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the Nicotine inhalator on Day 4.
672816|NCT02032212|B1|Baseline|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
672817|NCT02032212|P4|Participant Flow|Sequence 4|Subjects in this arm used the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.
672818|NCT02032212|P3|Participant Flow|Sequence 3|Subjects in this arm used the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.
672819|NCT02032212|P2|Participant Flow|Sequence 2|Subjects in this arm used the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.
672820|NCT02032212|P1|Participant Flow|Sequence 1|Subjects in this arm used the unflavoured EVP on Day 1, the flavoured EVP on Day 2, Nicotine inhalator on Day 3 and the conventional cigarette on Day 4.
672821|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
672822|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
672823|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
672824|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
672825|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
672826|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
672827|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
672828|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
672829|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
672830|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
672831|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
672832|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
672833|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
672834|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
672835|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
672836|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
672837|NCT02032212|O4|Outcome|Conventional Cigarette|Conventional cigarette (commercially available)
672838|NCT02032212|O3|Outcome|Nicotine Inhalator|Nicotine inhalator 15mg
672839|NCT02032212|O2|Outcome|EVP Flavoured|Flavoured e-vapour product
672840|NCT02032212|O1|Outcome|EVP Unflavoured|Unflavoured e-vapour product
672841|NCT02032212|E4|Reported Event|Conventional Cigarette|Conventional cigarette (commercially available)
672842|NCT02032212|E3|Reported Event|Nicotine Inhalator|Nicotine inhalator 15mg
672843|NCT02032212|E2|Reported Event|EVP Flavoured|Flavoured e-vapour product
672844|NCT02032212|E1|Reported Event|EVP Unflavoured|Unflavoured e-vapour product
672845|NCT02030600|B3|Baseline|Total|Total of all reporting groups
672846|NCT02030600|B2|Baseline|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672847|NCT02030600|B1|Baseline|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672848|NCT02030600|P2|Participant Flow|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
673288|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
672892|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672849|NCT02030600|P1|Participant Flow|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting self-measured plasma glucose (SMPG) values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672850|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672851|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672852|NCT02030600|O2|Outcome|Insulin Glargine/Insulin Degludec (IGlar/IDeg)|Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672853|NCT02030600|O1|Outcome|Insulin Degludec/Insulin Glargine (IDeg/IGlar)|Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672854|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672855|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672886|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672887|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672888|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
673289|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
672856|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672857|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672858|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672859|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672860|NCT02030600|O2|Outcome|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672861|NCT02030600|O1|Outcome|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672862|NCT02030600|E2|Reported Event|Insulin Glargine (IGlar)|Subjects receiving IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672889|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672890|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672891|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
706559|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
672863|NCT02030600|E1|Reported Event|Insulin Degludec (IDeg)|Subjects receiving IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
672864|NCT02030574|B1|Baseline|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
672865|NCT02030574|P1|Participant Flow|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
672866|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
672867|NCT02030574|O1|Outcome|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
672868|NCT02030574|E1|Reported Event|Gemcitabine and Fractionated Cisplatin (Combination Treatment)|"1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8~Gemcitabine and fractionated cisplatin (combination treatment): 1 Cycle = 21 days.~GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8"
672869|NCT02030535|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.
672870|NCT02030535|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study. (This is a cross-over trial consisting of a minimum two-week screening period. After screening, eligible patients were randomly assigned to one of 12 treatment sequences. Each patient received all three treatments as single doses on the three test days. Between test days with single dose administration there are 3-week washout periods.)
672871|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672872|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672873|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672874|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672875|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672876|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672877|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672878|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672879|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672880|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672881|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672882|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672883|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination) Olodaterol: 5 μg (2.5 μg per actuation) Tiotropium: 5 μg (2.5 μg per actuation) 2 inhalations a.m. dosing via RESPIMAT® inhaler
672884|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672885|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
673290|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
672893|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672894|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672895|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672896|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672897|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672898|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672899|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672900|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672901|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672902|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672903|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672904|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672905|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672906|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672907|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672908|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672909|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672910|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672911|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672912|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672913|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672914|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672915|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672916|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672917|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672918|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672919|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler."
672952|NCT02030041|O3|Outcome|Vitamin D and Placebo|Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks
673291|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
672920|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler."
672921|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations ante meridiem (a.m.) dosing."
672922|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
672923|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations (a.m. dosing) via RESPIMAT® inhaler"
672924|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672925|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672926|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672927|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672928|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672929|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672930|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672931|NCT02030535|O3|Outcome|Tiotropium 5μg + Olodaterol 5μg|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination (FC) (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672932|NCT02030535|O2|Outcome|Tio+Olo 5/5μg|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation.~2 inhalations a.m. dosing via RESPIMAT® inhaler"
672933|NCT02030535|O1|Outcome|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672934|NCT02030535|E3|Reported Event|Tiotropium and Olodaterol FC|"Single test dose of oral inhalation of tiotropium (5 μg) and olodaterol (5 μg) free combination FC (Tio/Olo free combination)~Olodaterol: 5 μg (2.5 μg per actuation)~Tiotropium: 5 μg (2.5 μg per actuation)~2 inhalations a.m. dosing."
672935|NCT02030535|E2|Reported Event|Tio+Olo FDC|"Single test dose of oral inhalation of Tio+Olo FDC(fixed dose combination) (5/5 μg) inhalation solution as fixed dose inhalation solution (Tio+Olo FDC) 2.5 μg each per actuation via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672936|NCT02030535|E1|Reported Event|Placebo|"Single test dose of oral inhalation of Placebo via RESPIMAT inhaler.~2 inhalations a.m. dosing."
672937|NCT02030405|B1|Baseline|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
672938|NCT02030405|P1|Participant Flow|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
672939|NCT02030405|O1|Outcome|Ixazomib (MLN9708)|Ixazomib was administered PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
672940|NCT02030405|O1|Outcome|Ixazomib (MLN9708)|Patients receive ixazomib orally on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
672941|NCT02030405|E1|Reported Event|Ixazomib (MLN9708)|Patients receive ixazomib PO on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
672942|NCT02030041|B4|Baseline|Total|Total of all reporting groups
672943|NCT02030041|B3|Baseline|Vitamin D and Placebo|Participants took vitamin D 60000 units once weekly and performed exercise for 12 weeks
672944|NCT02030041|B2|Baseline|Simvastatin and Vitamin D|Participants took simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
672945|NCT02030041|B1|Baseline|Simvastatin and Placebo|Participants took simvastatin 40 mg once daily and performed exercise for 12 weeks
672946|NCT02030041|P3|Participant Flow|Vitamin D and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks
672947|NCT02030041|P2|Participant Flow|Simvastatin and Vitamin D|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and vitamin D 60000 units once weekly, and will exercise for twelve weeks
672948|NCT02030041|P1|Participant Flow|Simvastatin and Placebo|Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and placebo once weekly , and will exercise for twelve weeks
672949|NCT02030041|O3|Outcome|Vitamin D and Placebo|Participants received vitamin D 60,000 units once weekly and performed exercise for 12 weeks
672950|NCT02030041|O2|Outcome|Simvastatin and Vitamin D|Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
672951|NCT02030041|O1|Outcome|Simvastatin and Placebo|Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks
676591|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
672953|NCT02030041|O2|Outcome|Simvastatin and Vitamin D|Participants received simvastatin 40 mg once daily and vitamin D 60,000 units once weekly, and performed exercise for 12 weeks
712372|NCT01778855|P2|Participant Flow|Hypothermia|IV t-PA and hypothermia
672954|NCT02030041|O1|Outcome|Simvastatin and Placebo|Participants received simvastatin 40 mg once daily and performed exercise for 12 weeks
672955|NCT02030041|E3|Reported Event|Vitamin D and Placebo|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive vitamin D 60,000 units once weekly and placebo once daily, and will exercise for twelve weeks~Vitamin D: Vitamin D will be given to achieve normal serum levels~Placebo: Placebo will be provided to the study participants"
672956|NCT02030041|E2|Reported Event|Simvastatin and Vitamin D|"Eleven participants will be vitamin D deficient with LDL-C between 100 to 130mg/dl This arm will receive simvastatin 40 mg once daily and vitamin D 60,000 units once weekly , and will exercise for twelve weeks~Vitamin D: Vitamin D will be given to achieve normal serum levels~Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants"
672957|NCT02030041|E1|Reported Event|Simvastatin and Placebo|"Eleven participants will be vitaminD deficient with LDL-C between 100 to 130mg/dl This arm will receive Simvastatin 40 mg once daily and placebo once weekly, and will exercise for twelve weeks~Simvastatin: Simvastatin in a dose of 40 mg will be provided to the study participants~Placebo: Placebo will be provided to the study participants"
672958|NCT02029989|B3|Baseline|Total|Total of all reporting groups
672959|NCT02029989|B2|Baseline|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
672960|NCT02029989|B1|Baseline|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
672961|NCT02029989|P2|Participant Flow|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
672962|NCT02029989|P1|Participant Flow|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
672963|NCT02029989|O2|Outcome|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
672964|NCT02029989|O1|Outcome|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
672965|NCT02029989|E2|Reported Event|No Comprehensive Medication Management Services (NCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference"
673027|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
706560|NCT01813721|O1|Outcome|Primary Analysis Set|
673062|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
672966|NCT02029989|E1|Reported Event|Pharmacist Comprehensive Medication Management Service (PCS)|"Glucose and Lipids and Glycosylated Hemoglobin A1c and Blood Pressure and Heart Rate and Body Mass Index and Waist and Hip Circumference and Comprehensive Medication Management~Cholestech LDX ®: Point-of-care (POCT) screening for diabetes and dyslipidemia.~Glucose and Lipids~A1c Now®: Point-of-care (POCT) screening for diabetes~Glycosylated Hemoglobin A1c~Omron ® Ultra Premium blood pressure monitor Model HEM-790IT: Point-of-care (POCT) screening for hypertension~Blood Pressure and Heart Rate~HealthOMeter® 500KL: Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared~QM2000 Circumference measuring tape: Measurement for Central Obesity~Waist and Hip circumference~Comprehensive Medication Management: Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management"
672967|NCT02029911|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672968|NCT02029911|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672969|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672970|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672971|NCT02029911|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672972|NCT02029911|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
672973|NCT02029846|B3|Baseline|Total|Total of all reporting groups
672974|NCT02029846|B2|Baseline|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
672975|NCT02029846|B1|Baseline|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
672976|NCT02029846|P2|Participant Flow|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
672977|NCT02029846|P1|Participant Flow|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
672978|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
672979|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
672980|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
672981|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
672982|NCT02029846|O2|Outcome|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
672983|NCT02029846|O1|Outcome|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
672984|NCT02029846|E2|Reported Event|Incretin-based Treatment|"A regimen including incretin-based drugs~Incretin-Based Treatment (GLP-1, DPP-4, amylin analogues): incretin-based drugs"
672985|NCT02029846|E1|Reported Event|Standard Treatment|"A regimen with traditional drugs only~Standard Treatment (insulin, metformin, sulfonylureas, TZDs): traditional drugs only"
672986|NCT02029755|B4|Baseline|Total|Total of all reporting groups
672987|NCT02029755|B3|Baseline|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672988|NCT02029755|B2|Baseline|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672989|NCT02029755|B1|Baseline|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672990|NCT02029755|P3|Participant Flow|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672991|NCT02029755|P2|Participant Flow|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
673028|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673292|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
672992|NCT02029755|P1|Participant Flow|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672993|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672994|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672995|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672996|NCT02029755|O3|Outcome|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672997|NCT02029755|O2|Outcome|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672998|NCT02029755|O1|Outcome|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
672999|NCT02029755|E3|Reported Event|PCA Only|"postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
673000|NCT02029755|E2|Reported Event|Local Infiltration|"postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~local infiltration: local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
673001|NCT02029755|E1|Reported Event|TAP Block|"postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery.~transversus abdominis plane block: bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia~Patient controlled analgesia: postoperative analgesia with intravenous patient controlled analgesia with morphine"
673002|NCT02029703|B3|Baseline|Total|Total of all reporting groups
673003|NCT02029703|B2|Baseline|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
673004|NCT02029703|B1|Baseline|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
673029|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
676592|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
673005|NCT02029703|P2|Participant Flow|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
673006|NCT02029703|P1|Participant Flow|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
673007|NCT02029703|O2|Outcome|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
673008|NCT02029703|O1|Outcome|Sham Injection|Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.
673009|NCT02029703|E2|Reported Event|Synvisc-One Injection|"Subjects randomized into the Synvisc-One group will receive a single 6 mL intra-articular injection of Synvisc-One under sterile conditions. The unblinded treating physician will prepare the treatment site according to his/her standard practice guidelines (i.e. after cutaneous numbing with a vasocoolant spray and / or local lidocaine injection), an 18 gauge needle will be advanced into one of three compartments of the knee using the injectors' technique of choice. Subjects will be monitored for a minimum 5 minutes post injection to evaluate for adverse events.~Synvisc-One Injection"
673010|NCT02029703|E1|Reported Event|Sham Injection|"Subjects randomized into this group will receive, under sterile conditions, a sham injection of lidocaine 1% (10 mg/ml) 1-2 ml. Sterile preparation of the affected knee (treatment site) and the sham injection procedure will take place after sterile preparation into subcutaneous tissue without involving treatment to the intra-articular joint. The sham procedure will be performed by the unblinded treating physician ONLY. This procedure will include an 22-25 gauge needle stick through the skin into the subcutaneous tissue without violating the joint capsule or performing arthrocentesis.~Sham Injection"
673011|NCT02029521|B3|Baseline|Total|Total of all reporting groups
673012|NCT02029521|B2|Baseline|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673013|NCT02029521|B1|Baseline|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673014|NCT02029521|P2|Participant Flow|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673015|NCT02029521|P1|Participant Flow|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673016|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673017|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673018|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673019|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673020|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673021|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673022|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673023|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673024|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673025|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673026|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673030|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673031|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673032|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673033|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673034|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673035|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673036|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673037|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673038|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673039|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673040|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673041|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673042|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673043|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673044|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673045|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673046|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673047|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673048|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673049|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673050|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673051|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673052|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673053|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673054|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673055|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673056|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673057|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673058|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673059|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673060|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673061|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
706561|NCT01813721|O1|Outcome|Primary Analysis Set|
673063|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673064|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673065|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673066|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673067|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673068|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673069|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673070|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673071|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673072|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673073|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673074|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673075|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673076|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673077|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673078|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673079|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673080|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673081|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673082|NCT02029521|O2|Outcome|Placebo Oral Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673083|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673084|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673085|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673086|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673140|NCT02028780|B1|Baseline|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
673165|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
717326|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
673087|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673088|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673089|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673090|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673091|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673092|NCT02029521|O2|Outcome|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673093|NCT02029521|O1|Outcome|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673094|NCT02029521|E2|Reported Event|Placebo Calcium Citrate|The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
673095|NCT02029521|E1|Reported Event|Oral Reduced L-glutathione|"The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg.~Oral reduced l-glutathione: The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime."
673096|NCT02029495|B4|Baseline|Total|Total of all reporting groups
673097|NCT02029495|B3|Baseline|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
673098|NCT02029495|B2|Baseline|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
673099|NCT02029495|B1|Baseline|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
673100|NCT02029495|P3|Participant Flow|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
673101|NCT02029495|P2|Participant Flow|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
673102|NCT02029495|P1|Participant Flow|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
673103|NCT02029495|O3|Outcome|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
673104|NCT02029495|O2|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
673105|NCT02029495|O1|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
673106|NCT02029495|O3|Outcome|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
673107|NCT02029495|O2|Outcome|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
673108|NCT02029495|O1|Outcome|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
673109|NCT02029495|E3|Reported Event|Placebo|"Administered via subcutaneous injection until week 24.~Placebo: Placebo administered via subcutaneous injection until week 24."
673110|NCT02029495|E2|Reported Event|140 mg Brodalumab|"Administered via subcutaneous injection~140 mg brodalumab: 140 mg brodalumab administered via subcutaneous injection"
673111|NCT02029495|E1|Reported Event|210 mg Brodalumab|"Administered via subcutaneous injections~210 mg brodalumab: 210 mg brodalumab administered via subcutaneous injection"
673112|NCT02029417|B1|Baseline|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
673113|NCT02029417|P1|Participant Flow|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
673275|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673114|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
673115|NCT02029417|O1|Outcome|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
673116|NCT02029417|E1|Reported Event|Treatment (Cytarabine, Omacetaxine Mepesuccinate, Decitabine)|"INDUCTION CHEMOTHERAPY: Patients receive cytarabine SC BID and omacetaxine mepesuccinate SC BID on days 1-14. Treatment for induction therapy repeats every 28 days for up to 4 courses or until patients achieve CR in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION THERAPY: Patients alternate courses between decitabine and OAG. Patients receive decitabine IV on days 1-5. Patients alternate with OAG courses, comprising cytarabine SC BID on days 1-7 and omacetaxine mepesuccinate SC BID on days 1-7. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.~cytarabine: Given SC~omacetaxine mepesuccinate: Given SC~decitabine: Given IV~laboratory biomarker analysis: Correlative studies"
673117|NCT02029196|B3|Baseline|Total|Total of all reporting groups
673118|NCT02029196|B2|Baseline|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
673119|NCT02029196|B1|Baseline|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
673120|NCT02029196|P2|Participant Flow|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
673121|NCT02029196|P1|Participant Flow|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
673122|NCT02029196|O2|Outcome|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
673123|NCT02029196|O1|Outcome|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
673124|NCT02029196|O2|Outcome|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
673125|NCT02029196|O1|Outcome|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
673126|NCT02029196|E2|Reported Event|Conventional Cigarette (CC)|Subjects who continue smoking their usual conventional cigarette (CC) brand.
673127|NCT02029196|E1|Reported Event|E-vapour Product (EVP)|Subjects who switch from using conventional cigarettes to using an e-vapour product (EVP).
673128|NCT02028780|B13|Baseline|Total|Total of all reporting groups
673129|NCT02028780|B12|Baseline|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673130|NCT02028780|B11|Baseline|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673131|NCT02028780|B10|Baseline|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673132|NCT02028780|B9|Baseline|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673133|NCT02028780|B8|Baseline|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673134|NCT02028780|B7|Baseline|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
673135|NCT02028780|B6|Baseline|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
673136|NCT02028780|B5|Baseline|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
673137|NCT02028780|B4|Baseline|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
673138|NCT02028780|B3|Baseline|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
673139|NCT02028780|B2|Baseline|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
673141|NCT02028780|P12|Participant Flow|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673142|NCT02028780|P11|Participant Flow|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673143|NCT02028780|P10|Participant Flow|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673144|NCT02028780|P9|Participant Flow|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673145|NCT02028780|P8|Participant Flow|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673146|NCT02028780|P7|Participant Flow|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
673147|NCT02028780|P6|Participant Flow|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
673148|NCT02028780|P5|Participant Flow|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
673149|NCT02028780|P4|Participant Flow|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
673150|NCT02028780|P3|Participant Flow|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
673151|NCT02028780|P2|Participant Flow|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
673152|NCT02028780|P1|Participant Flow|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
673153|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673154|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673155|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673156|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673157|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
673158|NCT02028780|O1|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
673159|NCT02028780|O7|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673160|NCT02028780|O6|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673161|NCT02028780|O5|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673162|NCT02028780|O4|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673163|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
673164|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
673166|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673167|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673168|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673169|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673170|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
673171|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
673172|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
673173|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
673174|NCT02028780|O8|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673175|NCT02028780|O7|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673176|NCT02028780|O6|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673177|NCT02028780|O5|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673178|NCT02028780|O4|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
673179|NCT02028780|O3|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
673180|NCT02028780|O2|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
673181|NCT02028780|O1|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
673182|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673183|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673184|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673185|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673186|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
673187|NCT02028780|O5|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673188|NCT02028780|O4|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673276|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673213|NCT02028780|E3|Reported Event|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
673189|NCT02028780|O3|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673190|NCT02028780|O2|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673191|NCT02028780|O1|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
673192|NCT02028780|O12|Outcome|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673193|NCT02028780|O11|Outcome|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673194|NCT02028780|O10|Outcome|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673195|NCT02028780|O9|Outcome|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673196|NCT02028780|O8|Outcome|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673197|NCT02028780|O7|Outcome|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
673198|NCT02028780|O6|Outcome|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
673199|NCT02028780|O5|Outcome|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
673200|NCT02028780|O4|Outcome|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
673201|NCT02028780|O3|Outcome|BI1000mg_5m (Dose group1 - Part I)|Subject received a single intravenous infusion of idarucizumab 1000mg for 5min on Day 1.
673202|NCT02028780|O2|Outcome|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
673203|NCT02028780|O1|Outcome|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
673204|NCT02028780|E12|Reported Event|DE+2500mg+2500mg (Dose group8 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with intravenously infusion of two doses of Idarucizumab 2500mg+2500mg for 5 min+5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673205|NCT02028780|E11|Reported Event|DE+4000mg_5m (Dose group7 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 4000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673206|NCT02028780|E10|Reported Event|DE+2000mg_5m (Dose group6 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 2000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673207|NCT02028780|E9|Reported Event|DE+1000mg_5m (Dose group5 - Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d.from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of Idarucizumab 1000 mg for 5 min, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673208|NCT02028780|E8|Reported Event|DE+Placebo+Placebo (Part II)|Subject received multiple oral doses of dabigatran etexilate 220 mg b.i.d. from Days 1 to 3 and q.d on Day 4 and from Days 8 to 10 and q.d on Day 11, followed with a single intravenously infusion of two doses of matching placebo to Idarucizumab for 5 min + 5 min, with a 15 min infusion interval between two doses, approximately 2 h after the last dose of dabigatran etexilate on Day 11.
673209|NCT02028780|E7|Reported Event|DE+Placebo_5m (Part II)|Subject received a multiple oral doses of dabigatran etexilate 220 mg twice daily(b.i.d.) from Days 1 to 3 and once daily(q.d)on Day 4 and from Days 8 to 10 and once daily(q.d)on Day 11,followed with a single intravenous infusion of matching placebo to idarucizumab for 5min, approximately 2h after the last dose of dabigatran etexilate on Day 11.
673210|NCT02028780|E6|Reported Event|BI8000mg_1h (Dose group4 - Part I)|Subject received a single intravenous infusion of idarucizumab 8000mg for 1h on Day 1.
673211|NCT02028780|E5|Reported Event|BI4000mg_5m (Dose group3 - Part I)|Subject received a single intravenous infusion of idarucizumab 4000mg for 5min on Day 1.
673212|NCT02028780|E4|Reported Event|BI2000mg_5m (Dose group2 - Part I)|Subject received a single intravenous infusion of idarucizumab 2000mg for 5min on Day 1.
673214|NCT02028780|E2|Reported Event|Placebo_1h (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 1h (hour) on Day 1.
673215|NCT02028780|E1|Reported Event|Placebo_5m (Part I)|Subject received a single intravenous infusion of matching placebo to idarucizumab once daily for 5min on Day 1.
673216|NCT02028767|B1|Baseline|Fixed Dose Combination vs. Separate Tablets|12.5 mg Empagliflozin / 500mg metformin fixed dose combination vs. free combination of 2.5 mg tablet Empagliflozin, 10 mg tablet Empagliflozin and 500 mg tablet Metformin
673217|NCT02028767|P2|Participant Flow|Separate Tablets First, Then Fixed Dose Combination (FDC)|"free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet first,~then Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
673218|NCT02028767|P1|Participant Flow|Fixed Dose Combination (FDC) First, Then Separate Tablets|"Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin first,~then free combination of Empagliflozin 2.5 mg tablet, Empagliflozin 10 mg tablet and Metformin 500 mg tablet~Both medications were administered oral with 240 mL water after intake of a high-fat, high-calorie meal."
673219|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
673220|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
673221|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
673222|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
673223|NCT02028767|O2|Outcome|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
673224|NCT02028767|O1|Outcome|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
673225|NCT02028767|E2|Reported Event|Separate Tablets|"Empagliflozin and Metformin tablets~Empagliflozin 2.5 mg: Empagliflozin 2.5 mg tablet~Empagliflozin 10 mg: Empagliflozin 10 mg tablet~Metformin 500 mg: Metformin 500 mg tablet"
673226|NCT02028767|E1|Reported Event|Fixed Dose Combination (FDC)|"12.5 mg Empagliflozin / 500mg metformin fixed dose combination~Empagliflozin / Metformin FDC: 12.5 mg Empagliflozin / 500 mg Metformin"
673227|NCT02028754|B3|Baseline|Total|Total of all reporting groups
673228|NCT02028754|B2|Baseline|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673229|NCT02028754|B1|Baseline|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673230|NCT02028754|P2|Participant Flow|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673231|NCT02028754|P1|Participant Flow|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673232|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673233|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673234|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673235|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673236|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673237|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673238|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673239|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673240|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673277|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673278|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673279|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673293|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673241|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673242|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673243|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673244|NCT02028754|O2|Outcome|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673245|NCT02028754|O1|Outcome|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673246|NCT02028754|E2|Reported Event|Conventional Therapy|Conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673247|NCT02028754|E1|Reported Event|Sodium Carboxymethylcellulose and Conventional Therapy|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days plus conventional therapy of levofloxacin for 7 days post-cataract surgery and prednisolone for 30 days post-cataract surgery each in the study eye up to 4 times a day.
673248|NCT02028676|B10|Baseline|Total|Total of all reporting groups
673249|NCT02028676|B9|Baseline|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
673250|NCT02028676|B8|Baseline|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
673251|NCT02028676|B7|Baseline|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
673252|NCT02028676|B6|Baseline|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
673253|NCT02028676|B5|Baseline|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673254|NCT02028676|B4|Baseline|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673255|NCT02028676|B3|Baseline|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673256|NCT02028676|B2|Baseline|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673280|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673281|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673282|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673283|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673284|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673285|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673286|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673257|NCT02028676|B1|Baseline|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673258|NCT02028676|P9|Participant Flow|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
673259|NCT02028676|P8|Participant Flow|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
673260|NCT02028676|P7|Participant Flow|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
673261|NCT02028676|P6|Participant Flow|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
673262|NCT02028676|P5|Participant Flow|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673263|NCT02028676|P4|Participant Flow|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673264|NCT02028676|P3|Participant Flow|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673265|NCT02028676|P2|Participant Flow|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673266|NCT02028676|P1|Participant Flow|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673267|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673268|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673269|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673270|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673271|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673272|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673273|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673274|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673294|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673295|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673296|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673297|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673298|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673299|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673300|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673301|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673302|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673303|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673304|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673305|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673306|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673307|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673308|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673309|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673310|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673311|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673312|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673313|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673314|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673315|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673316|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673317|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673318|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673319|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673320|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673321|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673322|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673323|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673324|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673325|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673326|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673327|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673328|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673329|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673330|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673331|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673458|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
676593|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
673726|NCT02024698|E1|Reported Event|Omafilcon A|Study participants are randomized to wear omafilcon A lenses.
673332|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673333|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673334|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673335|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673336|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673337|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673338|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673339|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673340|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673341|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673342|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673593|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673343|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673344|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673345|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673346|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673347|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673348|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673349|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673350|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673351|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673352|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673459|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673353|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673354|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673355|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673356|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673357|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673358|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673359|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673360|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673361|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673362|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673363|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673405|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673364|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673365|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673366|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673367|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673368|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673369|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673370|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673371|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673372|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673373|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673460|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673374|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673375|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673376|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673377|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673378|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673379|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673380|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673381|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673382|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673383|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673406|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673588|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
706562|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
673384|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673385|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673386|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673387|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673388|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673389|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673390|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673391|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673392|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673393|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673425|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673589|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673394|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673395|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673396|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673397|NCT02028676|O3|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673398|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673399|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673400|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
673401|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673402|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673403|NCT02028676|O5|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673404|NCT02028676|O4|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673590|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
673407|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673408|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673409|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673410|NCT02028676|O2|Outcome|Stopped Cotrimoxazole Prophylaxis|
673411|NCT02028676|O1|Outcome|Continued Cotrimoxazole Prophylaxis|"Other Names:~trimethoprim+sulfamethoxazole"
673412|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673413|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673414|NCT02028676|O2|Outcome|Twice-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673415|NCT02028676|O1|Outcome|Once-daily ABC+3TC|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa"
673416|NCT02028676|O3|Outcome|ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
673417|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673418|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673419|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
673420|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673421|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673422|NCT02028676|O3|Outcome|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age"
673423|NCT02028676|O2|Outcome|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"Other Names:~ZDV: zidovudine, azidothymidine, Retrovir ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ZDV+3TC co-formulated: Combivir ABC+3TC co-formulated: Kivexa ZDV+ABC+3TC co-formulated: Trizivir NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673424|NCT02028676|O1|Outcome|Arm A: ABC+3TC+NNRTI|"Other Names:~ABC: abacavir: Ziagen 3TC: lamivudine: Epivir ABC+3TC co-formulated: Kivexa NVP: nevirapine, Viramune EFV: efavirenz, Sustiva Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673456|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673591|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673426|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673427|NCT02028676|O2|Outcome|Laboratory Plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673428|NCT02028676|O1|Outcome|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673429|NCT02028676|E9|Reported Event|Stopped Cotrimoxazole Prophylaxis|"Children had been taking once-daily cotrimoxazole prophylaxis since at least ART initiation. Children randomised to this experimental arm stopped taking cotrimoxazole prophylaxis.~Stopped cotrimoxazole prophylaxis"
673430|NCT02028676|E8|Reported Event|Continued Cotrimoxazole Prophylaxis|"Once-daily doses 5-<15 kg: 200 mg of trimethoprim + 40 mg sulfamethoxazole 15-<30 kg: 400 mg trimethoprim + 80 mg sulfamethoxazole >=30 kg: 800 mg trimethoprim + 160 mg sulfamethoxazole~Continued cotrimoxazole prophylaxis"
673431|NCT02028676|E7|Reported Event|Twice-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO~Twice-daily ABC+3TC"
673432|NCT02028676|E6|Reported Event|Once-daily ABC+3TC|"ABC [abacavir]: syrup or tablet, dosed once-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed once-daily according to weight-bands following WHO~Once-daily ABC+3TC"
673433|NCT02028676|E5|Reported Event|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673434|NCT02028676|E4|Reported Event|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI Maintenance|"ZDV [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO NNRTI: either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance: Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673435|NCT02028676|E3|Reported Event|Arm A: Abacavir (ABC)+Lamivudine (3TC)+NNRTI|"ABC [abacavir]: syrup or tablet, dosed twice-daily according to weight-bands following WHO 3TC [lamivudine]: syrup or tablet, dosed twice-daily according to weight-bands following WHO non-nucleoside reverse transcriptase inhibitor (NNRTI): either nevirapine or efavirenz based on availability (provided by national ART programmes in Uganda/Zimbabwe). Nevirapine syrup or tablet dosed twice-daily according to weight-bands following WHO. Efavirenz tablets dosed once-daily according to weight-bands following WHO.~Arm A: ABC+3TC+NNRTI: Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age."
673436|NCT02028676|E2|Reported Event|Laboratory Plus Clinical Monitoring (LCM)|Laboratory plus Clinical Monitoring (LCM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673457|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673437|NCT02028676|E1|Reported Event|Clinically Driven Monitoring (CDM)|Clinically Driven Monitoring (CDM): Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
673438|NCT02028325|B1|Baseline|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
673439|NCT02028325|P1|Participant Flow|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
673440|NCT02028325|O1|Outcome|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
673441|NCT02028325|E1|Reported Event|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
673442|NCT02028169|B1|Baseline|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673443|NCT02028169|P1|Participant Flow|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed psoriatic arthritis (PsA) for which the physician has initiated treatment with an anti-tumor necrosis factor (TNF).
673444|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673445|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673446|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673447|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673448|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673449|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673450|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673451|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673452|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673453|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673454|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673455|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673461|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673462|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673463|NCT02028169|O1|Outcome|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673464|NCT02028169|E1|Reported Event|Participants Receiving Anti-TNF for PsA|Participants who are actively working (full-time or part-time) with rheumatologist-confirmed PsA for which the physician has initiated treatment with an anti-TNF.
673465|NCT02028065|B4|Baseline|Total|Total of all reporting groups
673466|NCT02028065|B3|Baseline|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673467|NCT02028065|B2|Baseline|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673468|NCT02028065|B1|Baseline|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673469|NCT02028065|P3|Participant Flow|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673470|NCT02028065|P2|Participant Flow|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673471|NCT02028065|P1|Participant Flow|Placebo|Administration of 3 single intravenous (IV) doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673472|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673473|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673474|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673475|NCT02028065|O3|Outcome|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673476|NCT02028065|O2|Outcome|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673477|NCT02028065|O1|Outcome|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673478|NCT02028065|E3|Reported Event|Sugammadex 16 mg/kg|Administration of 3 single IV doses of sugammadex 16 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673479|NCT02028065|E2|Reported Event|Sugammadex 4 mg/kg|Administration of 3 single IV doses of sugammadex 4 mg/kg, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673480|NCT02028065|E1|Reported Event|Placebo|Administration of 3 single IV doses of placebo, with an approximately 5-week washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3
673481|NCT02027883|B3|Baseline|Total|Total of all reporting groups
673482|NCT02027883|B2|Baseline|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
673483|NCT02027883|B1|Baseline|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
673484|NCT02027883|P2|Participant Flow|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
673485|NCT02027883|P1|Participant Flow|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
673486|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values~The educated T shock setting method was successful in 70% of the patients. 35 out of 50 patients Ventricular Fibrillation was induced with the educated T- shock method. Of the 12 patients that were did not have Ventricular fibrillation induced with the nominal T-shock method, they were all successfully induced with the educated T-Shock method."
673487|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust~The standard T-Shock method was successful in 76% of the patients. 38 out of 50 patients Ventricular Fibrillation was induced with the nominal T shock method. In contrast, 87 % or 13 out of 15 that failed to induce Ventricular Fibrillation using the educated T-Shock method was successfully induced when crossed to the nominal T-shock method."
673488|NCT02027883|O2|Outcome|Experimental Parameter|Educated T shock setting: Experimental Parameter Set 2 Programming Values.
673489|NCT02027883|O1|Outcome|Nominal Parameter|Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust.
673490|NCT02027883|O2|Outcome|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
673491|NCT02027883|O1|Outcome|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
673492|NCT02027883|E2|Reported Event|Experimental Parameter|"Educated T shock setting~Educated T shock setting: Experimental Parameter Set 2 Programming Values"
673493|NCT02027883|E1|Reported Event|Nominal Parameter|"Nominal T shock setting~Nominal T shock setting: Nominal Parameter Set 1 Programming Values for EnTrust"
673494|NCT02027844|B4|Baseline|Total|Total of all reporting groups
673495|NCT02027844|B3|Baseline|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
706563|NCT01813721|O1|Outcome|Primary Analysis Set - Investigators|
673496|NCT02027844|B2|Baseline|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
673497|NCT02027844|B1|Baseline|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
673498|NCT02027844|P3|Participant Flow|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
673499|NCT02027844|P2|Participant Flow|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
673500|NCT02027844|P1|Participant Flow|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
673501|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
673502|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
673503|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
673504|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
673505|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
673506|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
673507|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
673508|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
673509|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
673510|NCT02027844|O3|Outcome|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
673511|NCT02027844|O2|Outcome|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
673512|NCT02027844|O1|Outcome|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
673513|NCT02027844|E3|Reported Event|Combined|"parental presence and cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane~parental presence: parental presence during inhalational induction of sevoflurane"
673514|NCT02027844|E2|Reported Event|Paretnal Presence|"parental presence with their children during inhalational induction of anesthesia in the operating room~parental presence: parental presence during inhalational induction of sevoflurane"
673515|NCT02027844|E1|Reported Event|Cartoon|"cartoon watching by children during inhalational induction of anesthesia in the operating room~Cartoon: Cartoon watching by children during inhalational induction of sevoflurane"
673516|NCT02027402|B3|Baseline|Total|Total of all reporting groups
673517|NCT02027402|B2|Baseline|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
673518|NCT02027402|B1|Baseline|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
673519|NCT02027402|P2|Participant Flow|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
673520|NCT02027402|P1|Participant Flow|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
673521|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
673522|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
673523|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
673524|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
673525|NCT02027402|O2|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
673526|NCT02027402|O1|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
673527|NCT02027402|O2|Outcome|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
673528|NCT02027402|O1|Outcome|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
673529|NCT02027402|E2|Reported Event|no Drain Insertion|In this arm, investigators perform only laparoscopic cholecystectomy, and not insert a drain
673530|NCT02027402|E1|Reported Event|Drain Insertion|"Laparoscopic cholecystectomy with drain insertion is performed in this arm.~Laparoscopic cholecystectomy with drain insertion: In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in Morrison's pouch."
673531|NCT02027311|B3|Baseline|Total|Total of all reporting groups
673532|NCT02027311|B2|Baseline|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673533|NCT02027311|B1|Baseline|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673534|NCT02027311|P2|Participant Flow|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673535|NCT02027311|P1|Participant Flow|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673536|NCT02027311|O2|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673537|NCT02027311|O1|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673538|NCT02027311|O2|Outcome|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673539|NCT02027311|O1|Outcome|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673540|NCT02027311|E2|Reported Event|Midazolam|"This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Midazolam: This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673592|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
673594|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
673541|NCT02027311|E1|Reported Event|Etomidate|"This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Etomidate: This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.~Meperidine: Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus."
673542|NCT02027272|B3|Baseline|Total|Total of all reporting groups
673543|NCT02027272|B2|Baseline|Placebo|Placebo, 2 doses, 12 hours apart
673544|NCT02027272|B1|Baseline|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
673545|NCT02027272|P2|Participant Flow|Placebo|Placebo, 2 doses, 12 hours apart
673546|NCT02027272|P1|Participant Flow|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
673547|NCT02027272|O2|Outcome|Placebo|Placebo, 2 doses, 12 hours apart
673548|NCT02027272|O1|Outcome|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
673549|NCT02027272|E2|Reported Event|Placebo|Placebo, 2 doses, 12 hours apart
673550|NCT02027272|E1|Reported Event|Dexamethasone|"Dexamethasone 12 mg, 2 doses, 12 hours apart.~Dexamethasone: Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart"
673551|NCT02026206|B3|Baseline|Total|Total of all reporting groups
673552|NCT02026206|B2|Baseline|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673553|NCT02026206|B1|Baseline|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673554|NCT02026206|P2|Participant Flow|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673555|NCT02026206|P1|Participant Flow|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673556|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673557|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673558|NCT02026206|O2|Outcome|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673559|NCT02026206|O1|Outcome|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673560|NCT02026206|E2|Reported Event|Placebo-controlled Group|"Placebo low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles. The placebo LLLT device was identical to the active device but did not radiate light as the hole was blocked.~Placebo: we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673561|NCT02026206|E1|Reported Event|LLLT Group|"low-level light therapy (LLLT) was self-performed for 20 min/day over 5 days prior to the expected onset of menstruation during three menstrual cycles.~low-level light therapy: we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule."
673562|NCT02026193|B3|Baseline|Total|Total of all reporting groups
673563|NCT02026193|B2|Baseline|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
673564|NCT02026193|B1|Baseline|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
673565|NCT02026193|P2|Participant Flow|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
673566|NCT02026193|P1|Participant Flow|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
673567|NCT02026193|O2|Outcome|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
673568|NCT02026193|O1|Outcome|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
673569|NCT02026193|E2|Reported Event|Embryo Freezing|"All retrieved oocytes will be fertilized, and resulting embryos will be frozen.~embryo freezing"
673570|NCT02026193|E1|Reported Event|Oocyte Vitrification|"All retrieved mature oocytes will be vitrified.~oocyte vitrification"
673571|NCT02026141|B3|Baseline|Total|Total of all reporting groups
673572|NCT02026141|B2|Baseline|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
673573|NCT02026141|B1|Baseline|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr~Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation as defined by ASA.~Dexmedetomidine"
673574|NCT02026141|P2|Participant Flow|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
673575|NCT02026141|P1|Participant Flow|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
673576|NCT02026141|O2|Outcome|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
673577|NCT02026141|O1|Outcome|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
673578|NCT02026141|E2|Reported Event|Saline Placebo|"Patients will receive the standardized pre-op meds and spinal anesthetic. Once the spinal anesthetic is performed,~Patient will receive the same infusion rates as in the Dexmedetomidine arm, however with Normal Saline as a Placebo.~midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Normal Saline Placebo"
673579|NCT02026141|E1|Reported Event|Dexmedetomidine Arm|"Standardized pre-op meds and spinal anesthetic.~Once the patient's spinal is performed, patient will receive the following:~Start with bolus of 0.5micrgram/kg over 10 minutes, and then infusion of 0.5 microgram/kg/hr Infusion will be stopped after the last staple or suture is performed on the incision.~Both groups will have a midazolam 0.5mg prn q 5minutes to be used as a rescue to achieve moderate sedation.~Dexmedetomidine"
673580|NCT02025907|B3|Baseline|Total|Total of all reporting groups
673581|NCT02025907|B2|Baseline|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673582|NCT02025907|B1|Baseline|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
673583|NCT02025907|P2|Participant Flow|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673584|NCT02025907|P1|Participant Flow|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
673585|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673586|NCT02025907|O1|Outcome|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
673587|NCT02025907|O2|Outcome|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673595|NCT02025907|E2|Reported Event|Canagliflozin|Participants administered canagliflozin (JNJ-28431754) 100 milligram (mg) titratable to 300 mg once daily for 26 weeks.
673596|NCT02025907|E1|Reported Event|Placebo|Participants administered with placebo (inactive medication) once daily for 26 weeks.
673597|NCT02025829|B3|Baseline|Total|Total of all reporting groups
673598|NCT02025829|B2|Baseline|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
673599|NCT02025829|B1|Baseline|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
673600|NCT02025829|P2|Participant Flow|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
673601|NCT02025829|P1|Participant Flow|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
673602|NCT02025829|O2|Outcome|End of Exacerbation|Study volunteer at the completion of 2 weeks IV antibiotic treatment for a pulmonary exacerbation
673603|NCT02025829|O1|Outcome|Begining of Exacerbation|Study volunteer at the beginning of IV antibiotic treatment for a pulmonary exacerbation
673604|NCT02025829|O1|Outcome|Clinically Stable Cohort|Clinically stable subjects
673605|NCT02025829|O2|Outcome|End of Exacerbation|Study volunteer at the completion of 2 weeks IV antibiotic treatment for a pulmonary exacerbation
673606|NCT02025829|O1|Outcome|Begining of Exacerbation|Study volunteer at the beginning of IV antibiotic treatment for a pulmonary exacerbation
673607|NCT02025829|E2|Reported Event|Exacerbation|Patients with cystic fibrosis admitted for treatment of a pulmonary exacerbation with IV antibiotics, 10 subjects with one copy of F508del
673608|NCT02025829|E1|Reported Event|Clinically Stable|Patients with cystic fibrosis and are clinically stable, 10 subjects with one copy of F508del and 4 subjects with at least one copy of G551D
673609|NCT02025647|B1|Baseline|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673610|NCT02025647|P1|Participant Flow|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673611|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673612|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673613|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673614|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673615|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673616|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673617|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673618|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673619|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673620|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673621|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673622|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673623|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673624|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673625|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673626|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673627|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673628|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673629|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673630|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673631|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673632|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673633|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673634|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673635|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673636|NCT02025647|O1|Outcome|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673637|NCT02025647|E1|Reported Event|Innerview MHCDS|Innerview, Mental Health Clinical Decision Support tool
673638|NCT02025075|B3|Baseline|Total|Total of all reporting groups
673639|NCT02025075|B2|Baseline|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673640|NCT02025075|B1|Baseline|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673641|NCT02025075|P2|Participant Flow|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673642|NCT02025075|P1|Participant Flow|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673643|NCT02025075|O2|Outcome|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673644|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673645|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
673646|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
673647|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
673648|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
673649|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
673650|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
673651|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
673652|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
673653|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
673654|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
673655|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
673656|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
673657|NCT02025075|O6|Outcome|Moderate Neuromuscular Block (NMB): MOD(2nd) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (2nd TOF1) of TOF1-Deep-TOF1 group
673658|NCT02025075|O5|Outcome|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): Deep of TOF1-Deep-TOF1 group
673659|NCT02025075|O4|Outcome|Moderate Neuromuscular Block (NMB): MOD(1st) of TOF1-Deep-TOF1|Moderate Neuromuscular Block (NMB): MODERATE (1st TOF1) of TOF1-Deep-TOF1 group
673660|NCT02025075|O3|Outcome|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (2nd) of Deep-TOF1-Deep group
673661|NCT02025075|O2|Outcome|Deep Neuromuscular Block (NMB): MODERATE of of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): MODERATE (TOF1) of Deep-TOF1-Deep group
673662|NCT02025075|O1|Outcome|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep|Deep Neuromuscular Block (NMB): Deep (1st) of Deep-TOF1-Deep group
673663|NCT02025075|E2|Reported Event|Moderate Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 twitches in the train-on-four (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673664|NCT02025075|E1|Reported Event|Deep Neuromuscular Block (NMB)|"Muscle paralysis with rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (neuromuscular function monitor).~Rocuronium: Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB)."
673665|NCT02024971|B1|Baseline|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
673666|NCT02024971|P1|Participant Flow|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
673667|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
673668|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
673669|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
673670|NCT02024971|O1|Outcome|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
673671|NCT02024971|E1|Reported Event|Pioglitazone/Metformin Hydrochloride|Pioglitazone/metformin hydrochloride combination tablets, orally, for 12 months as prescribed by the standard of care.
673672|NCT02024867|B3|Baseline|Total|Total of all reporting groups
673673|NCT02024867|B2|Baseline|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673674|NCT02024867|B1|Baseline|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673675|NCT02024867|P2|Participant Flow|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673676|NCT02024867|P1|Participant Flow|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673677|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673678|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673679|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673680|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673681|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673682|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673683|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673684|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673685|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673686|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673687|NCT02024867|O2|Outcome|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673688|NCT02024867|O1|Outcome|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673689|NCT02024867|E2|Reported Event|10 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673690|NCT02024867|E1|Reported Event|3 Days|Trimethoprim-Sulfamethoxazole dosed at 10 mg Trimethoprim/kg/day divided twice a day, to a maximum of 640 mg Trimethoprim/day
673691|NCT02024724|B3|Baseline|Total|Total of all reporting groups
673692|NCT02024724|B2|Baseline|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
673693|NCT02024724|B1|Baseline|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
673694|NCT02024724|P2|Participant Flow|Group 1|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
673695|NCT02024724|P1|Participant Flow|Group 2|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
673696|NCT02024724|O2|Outcome|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
673697|NCT02024724|O1|Outcome|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
673698|NCT02024724|E2|Reported Event|Group 2|"40 mg of Triamcinolone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Triamcinolone: 40 mg of Triamcinolone"
673699|NCT02024724|E1|Reported Event|Group 1|"4 mg of Dexamethasone and 4 mL of 0.25% bupivacaine~Bupivacaine: 4 mL of 0.25% bupivacaine~Dexamethasone: 4 mg of Dexamethasone"
673700|NCT02024698|B1|Baseline|Overall Study Group|Study participants are randomized to wear omafilcon A or etafilcon A pair of study lenses then crossover to the alternate pair.
673701|NCT02024698|P2|Participant Flow|Omafilcon A First, Then Etafilcon A|Study participants are randomized to wear omafilcon A pair of study lenses then crossover to the alternate pair.
673702|NCT02024698|P1|Participant Flow|Etafilcon A First, Then Omafilcon A|Study participants are randomized to wear etafilcon A pair of study lenses then crossover to the alternate pair.
673703|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673704|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673705|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673706|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673707|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673708|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673709|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673710|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673711|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673712|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673713|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673714|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673715|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673716|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673717|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673718|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673719|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673720|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673721|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673722|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673723|NCT02024698|O2|Outcome|Etafilcon A|"Study participants are randomized to wear etafilcon A lenses.~Etafilcon A: contact lens"
673724|NCT02024698|O1|Outcome|Omafilcon A|"Study participants are randomized to wear omafilcon A lenses.~Omafilcon A: contact lens"
673725|NCT02024698|E2|Reported Event|Etafilcon A|Study participants are randomized to wear etafilcon A lenses.
706971|NCT01810380|B4|Baseline|Total|Total of all reporting groups
673728|NCT02024386|B3|Baseline|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673729|NCT02024386|B2|Baseline|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673730|NCT02024386|B1|Baseline|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673731|NCT02024386|P3|Participant Flow|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673732|NCT02024386|P2|Participant Flow|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673733|NCT02024386|P1|Participant Flow|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673734|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673735|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673736|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673737|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673738|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673739|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673740|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673741|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673742|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673743|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673744|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673745|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673746|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673747|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673748|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673749|NCT02024386|O3|Outcome|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673750|NCT02024386|O2|Outcome|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673751|NCT02024386|O1|Outcome|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude 90 minutes after Riociguat administration."
673752|NCT02024386|E3|Reported Event|Control Arm|"No drug~After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. A second VO2 max test will be repeated at altitude."
673753|NCT02024386|E2|Reported Event|Riociguat 1.0 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 1.0 mg~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
674680|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
673936|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
673754|NCT02024386|E1|Reported Event|Riociguat 0.5 mg|"Riociguat 0.5 mg tablets, one-time oral dose of 0.5~Riociguat: After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period. A second VO2 max test will be repeated at altitude."
673755|NCT02024165|B1|Baseline|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and Ultrasound
673756|NCT02024165|P1|Participant Flow|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE and Ultrasound
673757|NCT02024165|O2|Outcome|Electrode Sensor, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or Ultrasound
673758|NCT02024165|O1|Outcome|Electrode Sensor, FSE|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, and/or FSE
673759|NCT02024165|E1|Reported Event|Electrode Sensor, FSE, Ultrasound|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor and/or FSE and ultrasound
673760|NCT02023918|B1|Baseline|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
673761|NCT02023918|P1|Participant Flow|Pegvisomant Arm|"Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.~pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study."
673762|NCT02023918|O1|Outcome|Pegvisomant Arm|Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
673763|NCT02023918|O1|Outcome|Pegvisomant Arm|Pegvisomant 20 mg subcutaneously Qday x 28 days will be administered by the study subject.
673764|NCT02023918|E1|Reported Event|Pegvisomant Arm|pegvisomant: Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
673765|NCT02023879|B4|Baseline|Total|Total of all reporting groups
673766|NCT02023879|B3|Baseline|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673767|NCT02023879|B2|Baseline|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673768|NCT02023879|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673769|NCT02023879|P3|Participant Flow|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection every 4 weeks (Q4W) alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673770|NCT02023879|P2|Participant Flow|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted low-density lipoprotein cholesterol (LDL-C) levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673771|NCT02023879|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable non-statin lipid modifying therapy (LMT) or diet alone for 24 weeks.
673772|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673773|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673774|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673775|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673776|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673777|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673778|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673932|NCT02023112|B2|Baseline|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
676594|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
673779|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673780|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673781|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673782|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673783|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673784|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673785|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673786|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673787|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673788|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673789|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673790|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673791|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673792|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673793|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673794|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673795|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673796|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673797|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673798|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673799|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673933|NCT02023112|B1|Baseline|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
674681|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
673800|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673801|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673802|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673803|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673804|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673805|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673806|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673807|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673808|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673809|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673810|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673811|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673812|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673813|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673814|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673815|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673816|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673817|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673818|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673819|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673820|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673934|NCT02023112|P2|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
674837|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
673821|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673822|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673823|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673824|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673825|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673826|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673827|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673828|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673829|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673830|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673831|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673832|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673833|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673834|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673835|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673836|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673837|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673838|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673839|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673840|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673841|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673935|NCT02023112|P1|Participant Flow|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks
674873|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
673842|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673843|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673844|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673845|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673846|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673847|NCT02023879|O3|Outcome|Alirocumab 150 mg Q4W/Up to 150 mg Q2W|Alirocumab 150 mg SC injection Q4W alternating with placebo (for alirocumab) Q4W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673848|NCT02023879|O2|Outcome|Alirocumab 75 mg Q2W/Up to 150 mg Q2W (Calibrator)|Alirocumab 75 mg SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when targeted LDL-C levels at Week 8 were not achieved i.e. LDL-C ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) depending on cardiovascular risk or <30% LDL-C reduction from baseline.
673849|NCT02023879|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable non-statin LMT or diet alone for 24 weeks.
673850|NCT02023879|E3|Reported Event|Alirocumab 150 Q4W/Up150 Q2W|Participants exposed to alirocumab 150 mg Q4W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 22 weeks).
673851|NCT02023879|E2|Reported Event|Alirocumab 75 Q2W/Up150 Q2W|Participants exposed to alirocumab 75 mg Q2W/up to 150 mg Q2W SC injection added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
673852|NCT02023879|E1|Reported Event|Placebo Q2W|Participants exposed to placebo SC injection Q2W added to stable non-statin LMT or diet alone (mean exposure of 23 weeks).
673853|NCT02023801|B1|Baseline|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
673854|NCT02023801|P1|Participant Flow|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
673855|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
673856|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
673857|NCT02023801|O1|Outcome|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
673858|NCT02023801|E1|Reported Event|Aurora Treatment Arm|"Endometrial Ablation~Aurora Endometrial Ablation System: Ablation of the endometrial lining of the uterus using the Aurora System"
673859|NCT02023268|B3|Baseline|Total|Total of all reporting groups
673860|NCT02023268|B2|Baseline|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
673861|NCT02023268|B1|Baseline|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
673862|NCT02023268|P2|Participant Flow|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
673863|NCT02023268|P1|Participant Flow|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
673864|NCT02023268|O2|Outcome|Vismed|Vismed : 1 drop in each eye 3 to 6 times daily during 84 days
673865|NCT02023268|O1|Outcome|T2762|T2762: drop in each eye 3 to 6 times daily during 84 days
673866|NCT02023268|E2|Reported Event|Vismed®|Vismed®: 1 drop in each eye 3 to 6 times daily during 84 days
673867|NCT02023268|E1|Reported Event|T2762|T2762: 1 drop in each eye 3 to 6 times daily during 84 days
673868|NCT02023125|B3|Baseline|Total|Total of all reporting groups
673869|NCT02023125|B2|Baseline|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673870|NCT02023125|B1|Baseline|Group 1 (Treatment Sequence AB or BA)|Participants in Group 1 were randomly assigned to a two period treatment sequence (AB or BA) in which they received a single, oral dose of 600 mg of alectinib per period separated by at least 10 days. Each participant received single, oral doses alectinib given under fasted conditions (Treatment A) or following the ingestion of a high fat, high calorie meal (Treatment B) as determined by their assigned sequence.
673888|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673889|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673871|NCT02023125|P3|Participant Flow|Group 2: Alectinib Alone, Alectinib + Esomeprazole|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1. Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673872|NCT02023125|P2|Participant Flow|Group 1: Treatment B First, Then Treatment A|Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered. Each period was separated by at least 10 days.
673873|NCT02023125|P1|Participant Flow|Group 1: Treatment A First, Then Treatment B|Treatment A (Fasted Treatment): Following an overnight fast of at least 10 hours, a single 600 milligrams (mg) oral dose of alectinib was administered. Treatment B (Fed Treatment): Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Each period was separated by at least 10 days.
673874|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673875|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673876|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673877|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673878|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673879|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673880|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673881|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673882|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Day 16): Participants started the standardized meal 30 minutes prior to administration of alectinib. Participants were to consume this meal in 30 minutes or less. A single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal. Period 2 (Days 11 to 20): From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40-mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal.
673883|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673884|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673885|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673886|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673887|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
676595|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient.
673890|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673891|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673892|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673893|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673894|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673895|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673896|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673897|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673898|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673899|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673900|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673901|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673902|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673903|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673904|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673905|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673906|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673907|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673908|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673909|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673930|NCT02023125|E1|Reported Event|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673910|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673911|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673912|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673913|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673914|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673915|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673916|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673917|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673918|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673919|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673920|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673921|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673922|NCT02023125|O2|Outcome|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673923|NCT02023125|O1|Outcome|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673924|NCT02023125|O2|Outcome|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673925|NCT02023125|O1|Outcome|Group 1: Treatment A (Fasted Treatment)|Following an overnight fast of at least 10 hours, a single 600-mg oral dose of alectinib was administered.
673926|NCT02023125|E5|Reported Event|Group 2: Period 2 (Alectinib + Esomeprazole)|Period 2 (Days 11 to 20): Participants received oral esomeprazole 40 mg once daily for 6 days (Days 11-16) in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast; On Day 16, following an overnight fast of at least 10 hours, a single oral dose of 40 mg esomeprazole was administered 1.5 hours prior to the start of a standardized meal. Following a standardized meal, a single oral 600 mg dose of alectinib was then administered.
673927|NCT02023125|E4|Reported Event|Group 2: Period 2 (Esomeprazole Alone)|Period 2: From Days 11 to 15 esomeprazole 40 mg was administered orally once daily in the morning after an overnight fast of at least 10 hours, and at least 1 hour before a regular breakfast.
673928|NCT02023125|E3|Reported Event|Group 2: Period 1 (Alectinib Alone)|Period 1 (Days 1 to 10): Following an overnight fast of at least 10 hours, participants started a standardized meal and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal on Day 1 of Period 1.
673929|NCT02023125|E2|Reported Event|Group 1: Treatment B (Fed Treatment)|Following an overnight fast of at least 10 hours, participants started a high-fat, high-calorie meal 30 minutes prior to study drug administration and were to consume the meal in 30 minutes or less. The single 600-mg oral dose of alectinib was administered 30 minutes after the start of the meal.
673931|NCT02023112|B3|Baseline|Total|Total of all reporting groups
673937|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
673938|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
673939|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
673940|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
673941|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
673942|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
673943|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
673944|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
673945|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
673946|NCT02023112|O2|Outcome|ABT-450/r/ABT-267 Plus RBV for 16 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks
673947|NCT02023112|O1|Outcome|ABT-450/r/ABT-267 Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks
673948|NCT02023112|E4|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in cirrhotic participants
673949|NCT02023112|E3|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in cirrhotic participants
673950|NCT02023112|E2|Reported Event|ABT-450/r/ABT-267 Plus RBV for 16 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks in non-cirrhotic participants
673951|NCT02023112|E1|Reported Event|ABT-450/r/ABT-267 Plus RBV for 12 Weeks (Non-cirrhotic)|ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 12 weeks in non-cirrhotic participants
673952|NCT02023099|B4|Baseline|Total|Total of all reporting groups
673953|NCT02023099|B3|Baseline|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
673954|NCT02023099|B2|Baseline|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673955|NCT02023099|B1|Baseline|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673956|NCT02023099|P3|Participant Flow|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
673957|NCT02023099|P2|Participant Flow|Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA|DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673958|NCT02023099|P1|Participant Flow|Substudy 1, Arm A: DB 2-DAA|Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis
673959|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673960|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
673961|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673962|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673963|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
673964|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673965|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673966|NCT02023099|O2|Outcome|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
673967|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673968|NCT02023099|O1|Outcome|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673969|NCT02023099|E4|Reported Event|Substudy 2, Arm C: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis
673970|NCT02023099|E3|Reported Event|Substudy 1, Arm B: OL 2-DAA|OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis
673971|NCT02023099|E2|Reported Event|Substudy 1, Arm B: DB Placebo|DB placebo QD for 12 weeks in participants without cirrhosis
673972|NCT02023099|E1|Reported Event|Substudy 1, Arm A: DB 2-DAA|DB 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents [2-DAA]) once daily (QD) for 12 weeks in participants without cirrhosis.
673973|NCT02022670|B4|Baseline|Total|Total of all reporting groups
673974|NCT02022670|B3|Baseline|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673975|NCT02022670|B2|Baseline|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673976|NCT02022670|B1|Baseline|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
673977|NCT02022670|P3|Participant Flow|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673978|NCT02022670|P2|Participant Flow|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673979|NCT02022670|P1|Participant Flow|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
673980|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673981|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673982|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks~Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
673983|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673984|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673985|NCT02022670|O1|Outcome|Placebo|"inert oral capsules (0 mg sodium nitrite morning; 0 mg sodium nitrite in evening) for 10 weeks~Placebo: Sugar pill manufactured to mimic sodium nitrite capsules"
673986|NCT02022670|O3|Outcome|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673987|NCT02022670|O2|Outcome|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673988|NCT02022670|O1|Outcome|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
673989|NCT02022670|E3|Reported Event|Sodium Nitrite 160 mg/d|"160 mg/day (80 mg in morning; 80 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673990|NCT02022670|E2|Reported Event|Sodium Nitrite 80 mg/d|"80 mg/day (40 mg in morning; 40 mg in evening) oral capsules for 10 weeks~Sodium Nitrite: 80 mg/d or 160 mg/d"
673991|NCT02022670|E1|Reported Event|Placebo|Placebo: Sugar pill manufactured to mimic sodium nitrite capsules
673992|NCT02022085|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
673993|NCT02022085|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
673994|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
673995|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
673996|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674291|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674294|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
673997|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
673998|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
673999|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674000|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674001|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674002|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674003|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674004|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674005|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674006|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674007|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674008|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674009|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674010|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674011|NCT02022085|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674012|NCT02022085|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System: The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling."
674013|NCT02022020|B1|Baseline|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
674014|NCT02022020|P1|Participant Flow|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
674015|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
674016|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
674292|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674017|NCT02022020|O1|Outcome|Dabigatran (Pradax® in Canada; Pradaxa® in the United States)|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
674018|NCT02022020|E1|Reported Event|Dabigatran (Pradax® in Canada; Pradaxa® in the United States|Patients with Non-Valvular Atrial Fibrillation (NVAF) at two countries (United States and Canada) who received dabigatran etexilate (dabigatran capsules were approved at the 75 mg, 110 mg and 150 mg dosages, and the recommended dosing is orally twice daily).
674019|NCT02021461|B1|Baseline|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
674020|NCT02021461|P1|Participant Flow|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
674021|NCT02021461|O3|Outcome|ESL Tutti-Frutti Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Tutti-Frutti taste"
674022|NCT02021461|O2|Outcome|ESL Grape Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Grape taste"
674023|NCT02021461|O1|Outcome|ESL Banana Taste|"ESL was supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.~ESL Banana taste"
674024|NCT02021461|E1|Reported Event|Eslicarbazepine Acetate|Eslicarbazepine acetate (ESL) supplied as an oral suspension with 3 different flavours at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
674025|NCT02021331|B3|Baseline|Total|Total of all reporting groups
674026|NCT02021331|B2|Baseline|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
674027|NCT02021331|B1|Baseline|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
674028|NCT02021331|P2|Participant Flow|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
674029|NCT02021331|P1|Participant Flow|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
674030|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
674031|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
674032|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
674033|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
674034|NCT02021331|O2|Outcome|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
674035|NCT02021331|O1|Outcome|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
674036|NCT02021331|E2|Reported Event|Immediate Implant Placement With Immediate Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will get a temporary crown on the implant.~immediate implant placement with immediate provisionalization"
674037|NCT02021331|E1|Reported Event|Immediate Implant Placement Without Provisionalization|"The subject will have the tooth removed and an implant placed right away. In this arm the subject will have no temporary crown on the implant.~immediate implant placement without provisionalization"
674038|NCT02021071|B3|Baseline|Total|Total of all reporting groups
674039|NCT02021071|B2|Baseline|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
674040|NCT02021071|B1|Baseline|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
674041|NCT02021071|P2|Participant Flow|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
674042|NCT02021071|P1|Participant Flow|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
674043|NCT02021071|O2|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
674044|NCT02021071|O1|Outcome|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data)~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
674045|NCT02021071|O1|Outcome|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
674046|NCT02021071|E2|Reported Event|XperGuide With Virtual Path Planning|"Image-guided needle procedures with XperGuide with virtual path planning~XperGuide with virtual path planning: Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff."
674047|NCT02021071|E1|Reported Event|XperGuide|"Image-guided needle procedures with XperGuide performed prior to this study within institution (retrospective data).~XperGuide: Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT."
674048|NCT02020941|B1|Baseline|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674049|NCT02020941|P1|Participant Flow|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674050|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674051|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674052|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674053|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674054|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674071|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674072|NCT02020577|E2|Reported Event|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674055|NCT02020941|O1|Outcome|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674056|NCT02020941|E1|Reported Event|Treatment (Carfilzomib, Dexamethasone)|"TREATMENT PHASE (COURSES 1-8): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 8, 9, 15, and 16. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving less than PR also receive dexamethasone PO or IV weekly in courses 4-8.~MAINTENANCE PHASE (COURSES 9-14): Patients receive carfilzomib IV over 30 minutes on days 1, 2, 15, and 16. Patients who received dexamethasone in the Treatment Phase continue to receive dexamethasone PO or IV weekly. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~carfilzomib: Given IV~dexamethasone: Given IV or PO~laboratory biomarker analysis: Correlative studies"
674057|NCT02020863|B1|Baseline|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
674058|NCT02020863|P1|Participant Flow|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
674059|NCT02020863|O1|Outcome|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
674060|NCT02020863|E1|Reported Event|Closed Loop|"Study patients will receive a baseline crystalloid infusion of 3 cc/kg/hr and all additional fluid management will be performed via a closed loop (automated) system that will determine rate, amount, and timing of fluid administration.~Closed Loop: Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors."
674061|NCT02020577|B3|Baseline|Total|Total of all reporting groups
674062|NCT02020577|B2|Baseline|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674063|NCT02020577|B1|Baseline|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674064|NCT02020577|P2|Participant Flow|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674065|NCT02020577|P1|Participant Flow|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674066|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674067|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674068|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674069|NCT02020577|O1|Outcome|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674070|NCT02020577|O2|Outcome|Afatinib 40mg+Cetuximab 250 mg/m²|In each treatment cycle, patient were administered 40 mg Film-coated tablet daily afatinib in combination with escalating dose levels of afatinib and cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674909|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674073|NCT02020577|E1|Reported Event|Afatinib 30mg+Cetuximab 250 mg/m²|In each 21 day treatment cycle, patients were administered 30 mg Film-coated tablet daily afatinib in combination with cetuximab. An initial loading dose of cetuximab 400mg/m2 was administered intravenously at Day1 Cycle1, followed by cetuximab 250mg/m² weekly dose.
674074|NCT02020512|B1|Baseline|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
674075|NCT02020512|P1|Participant Flow|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
674076|NCT02020512|O1|Outcome|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
674077|NCT02020512|E1|Reported Event|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
674078|NCT02020369|B3|Baseline|Total|Total of all reporting groups
674079|NCT02020369|B2|Baseline|FVIIa 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
674080|NCT02020369|B1|Baseline|FVIIa 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): First Intervention (3 months), Second Intervention (3 months), continue cycle until end of study.
674081|NCT02020369|P2|Participant Flow|FVIIa: 75 µg/kg First, Then 225 µg/kg|Coagulation Factor VIIa (Recombinant): Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
674082|NCT02020369|P1|Participant Flow|FVIIa: 225 µg/kg First, Then 75 µg/kg|Coagulation Factor VIIa (Recombinant) : First Intervention (3 months), Second Intervention (3 months), repeat sequence for entirety of study.
674083|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674084|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674085|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674086|NCT02020369|O1|Outcome|Factor VIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674087|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674088|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674089|NCT02020369|O2|Outcome|FVIIa: 225 µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674090|NCT02020369|O1|Outcome|FVIIa: 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674091|NCT02020369|O2|Outcome|FVIIa 225µg/kg|225 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674092|NCT02020369|O1|Outcome|FVIIa 75 µg/kg|75 µg/kg Treatment Regimen at Time of Mild/Moderate Bleeding Episode
674093|NCT02020369|E2|Reported Event|Coagulation Factor VIIa (Recombinant): 225 µg/kg|"Coagulation Factor VIIa (Recombinant) : 225 µg/kg for 3 months~Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
674094|NCT02020369|E1|Reported Event|Coagulation Factor VIIa (Recombinant): 75 µg/kg|"Coagulation Factor VIIa (Recombinant): 75 µg/kg for 3 months~Coagulation Factor VIIa (Recombinant): A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX"
674095|NCT02020135|B3|Baseline|Total|Total of all reporting groups
674096|NCT02020135|B2|Baseline|PSMA ADC Chemotherapy-naive|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
674097|NCT02020135|B1|Baseline|PSMA ADC Chemotherapy-experienced|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
674098|NCT02020135|P1|Participant Flow|Arm 1: PSMA ADC|"Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required.~PSMA ADC: Upon recommendation from the PI and after Sponsor approval, a subject benefitting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations."
674099|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674201|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
675050|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
674100|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674101|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674102|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674103|NCT02020135|O2|Outcome|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674104|NCT02020135|O1|Outcome|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674105|NCT02020135|E2|Reported Event|PSMA ADC Chemotherapy-naive|"The chemotherapy-naïve group was comprised of 3 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674106|NCT02020135|E1|Reported Event|PSMA ADC Chemotherapy-experienced|"The chemotherapy-experienced group was comprised of 6 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).~Subjects started the extension study at the same dose received upon completion of the core PSMA ADC 2301 study. Each PSMA ADC dose was administered as an IV infusion over approximately 60 minutes once every three weeks (Q3W) for up to eight doses, unless a dose delay or dose reduction was required."
674107|NCT02020031|B3|Baseline|Total|Total of all reporting groups
674108|NCT02020031|B2|Baseline|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
674109|NCT02020031|B1|Baseline|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
674110|NCT02020031|P2|Participant Flow|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
674111|NCT02020031|P1|Participant Flow|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
674112|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
674113|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
674114|NCT02020031|O2|Outcome|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
674115|NCT02020031|O1|Outcome|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
674116|NCT02020031|E2|Reported Event|Vancomycin 1g IV|Vancomycin 1g is administered via forearm vein, given over a one-hour infusion, timed to finish approximately 30 minutes prior to tourniquet inflation.
674117|NCT02020031|E1|Reported Event|Vancomycin 500mg Intraosseous|Vancomycin 500mg is given via intraosseous regional administration (IORA) into a proximal tibial cannula, after tourniquet inflation and immediately prior to skin incision.
674118|NCT02019563|B3|Baseline|Total|Total of all reporting groups
674119|NCT02019563|B2|Baseline|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674520|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674120|NCT02019563|B1|Baseline|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674121|NCT02019563|P2|Participant Flow|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674122|NCT02019563|P1|Participant Flow|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674123|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674124|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674125|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674126|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674127|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~RCT Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674128|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~MTA/FS pulpotomy Group: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674129|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674130|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674131|NCT02019563|O2|Outcome|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674132|NCT02019563|O1|Outcome|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674133|NCT02019563|E2|Reported Event|RCT Group|"Children randomized to this group will undergo the root canal therapy (RCT) technique.~Root canal therapy (RCT): After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE."
674134|NCT02019563|E1|Reported Event|MTA/FS Pulpotomy Group|"Children randomized to this arm will undergo a mineral trioxide aggregate (MTA) pulpotomy after hemostasis is achieved using ferric sulfate (FS).~Mineral trioxide aggregate/ferric sulfate (MTA/FS) pulpotomy: After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface."
674135|NCT02019550|B3|Baseline|Total|Total of all reporting groups
675051|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
674136|NCT02019550|B2|Baseline|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674137|NCT02019550|B1|Baseline|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674138|NCT02019550|P2|Participant Flow|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674139|NCT02019550|P1|Participant Flow|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 microgram (mcg) subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674140|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674141|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674142|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674143|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674144|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674145|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674146|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674147|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674148|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674149|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674150|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674151|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674152|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674153|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674202|NCT02017574|E2|Reported Event|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674154|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674155|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674156|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674157|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674158|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674159|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674160|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674161|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674162|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674163|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674164|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674165|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674166|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674167|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674168|NCT02019550|O2|Outcome|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
674169|NCT02019550|O1|Outcome|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
674170|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674171|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674172|NCT02019550|O2|Outcome|First Rebiject II, Then Rebif Rebidose|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 2 for the next 4 weeks.
674203|NCT02017574|E1|Reported Event|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674173|NCT02019550|O1|Outcome|First Rebif Rebidose, Then Rebiject II|Subjects self-injected Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in Treatment Period 1 for 4 weeks followed by self-injecting Rebif at a dose of 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in Treatment Period 2 for the next 4 weeks.
674174|NCT02019550|E2|Reported Event|Rebiject II|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebiject II self-injector device in either Treatment Period 1 or 2.
674175|NCT02019550|E1|Reported Event|Rebif Rebidose|Subjects who were injected with Rebif 44 mcg subcutaneously three times a week by using Rebif Rebidose self-injector device in either Treatment Period 1 or 2.
674176|NCT02018809|B5|Baseline|Total|Total of all reporting groups
674177|NCT02018809|B4|Baseline|Arm 4|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674178|NCT02018809|B3|Baseline|Arm 3|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674179|NCT02018809|B2|Baseline|Arm 2|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674180|NCT02018809|B1|Baseline|Arm 1|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674181|NCT02018809|P4|Participant Flow|Arm 4|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674182|NCT02018809|P3|Participant Flow|Arm 3|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674183|NCT02018809|P2|Participant Flow|Arm 2|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674184|NCT02018809|P1|Participant Flow|Arm 1|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674185|NCT02018809|O4|Outcome|Arm 4|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674186|NCT02018809|O3|Outcome|Arm 3|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674187|NCT02018809|O2|Outcome|Arm 2|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674188|NCT02018809|O1|Outcome|Arm 1|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674189|NCT02018809|E4|Reported Event|Arm 4|"Usual care with GlowCap.~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674190|NCT02018809|E3|Reported Event|Arm 3|"The subject’s MAP receives notification if the subject missed >2 consecutive daily doses of statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674191|NCT02018809|E2|Reported Event|Arm 2|"The subject’s MAP receives weekly about how often the subject took statin during previous week.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674192|NCT02018809|E1|Reported Event|Arm 1|"The subject’s MAP receives daily notification about whether subject took statin.~Medication Adherence Partner~Electronic pill bottle: This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial."
674193|NCT02017574|B3|Baseline|Total|Total of all reporting groups
674194|NCT02017574|B2|Baseline|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674195|NCT02017574|B1|Baseline|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674196|NCT02017574|P2|Participant Flow|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674197|NCT02017574|P1|Participant Flow|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674198|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674199|NCT02017574|O1|Outcome|Implicit Group|"Receives little feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674200|NCT02017574|O2|Outcome|Control|"Receives detailed feedback about task performance during learning~Reaching Task: Learn a reaching task that requires coordination of the arm segments"
674207|NCT02017093|P2|Participant Flow|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
674208|NCT02017093|P1|Participant Flow|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
674209|NCT02017093|O2|Outcome|Control Group|"Training of the upper extremity, using a robotic devise without forces applied and traditional therapy.~control treatment: Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
674210|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic devise with error enhanced forces and traditional therapy.~Error Enhancement: Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions."
674211|NCT02017093|O2|Outcome|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
674212|NCT02017093|O1|Outcome|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
674213|NCT02017093|E2|Reported Event|Control Group: Traditional Therapy|"Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
674214|NCT02017093|E1|Reported Event|Error Enhancement|"Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy.~Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement~Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included."
674215|NCT02017015|B1|Baseline|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
674216|NCT02017015|P1|Participant Flow|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 by IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
674217|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
674218|NCT02017015|O1|Outcome|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
674219|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
674220|NCT02017015|O1|Outcome|Nab-paclitaxel and Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
674221|NCT02017015|E1|Reported Event|Nab-paclitaxel With Gemcitabine|Nab-paclitaxel 125 mg/m^2 by intravenous (IV) infusion over 30 - 40 minutes followed by gemcitabine 1000 mg/ m^2 IV infusion over 30 - 40 minutes once weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest (28 day cycle).
674222|NCT02016963|B1|Baseline|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674223|NCT02016963|P1|Participant Flow|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
675052|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
674224|NCT02016963|O1|Outcome|Raxibacumab IV|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674225|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674226|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674227|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674228|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674229|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674230|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674231|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674232|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674233|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674234|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674235|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674236|NCT02016963|O1|Outcome|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674237|NCT02016963|E1|Reported Event|Raxibacumab|Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
674238|NCT02016690|B1|Baseline|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674239|NCT02016690|P1|Participant Flow|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674240|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674241|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674242|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674243|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674244|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674245|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674246|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674247|NCT02016690|O1|Outcome|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674248|NCT02016690|E1|Reported Event|Immunocompromised Children|Children with immunocompromised conditions or Down syndrome at high-risk of serious RSV disease who received palivizumab during the RSV season
674249|NCT02016625|B3|Baseline|Total|Total of all reporting groups
674250|NCT02016625|B2|Baseline|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
674251|NCT02016625|B1|Baseline|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
674293|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674252|NCT02016625|P2|Participant Flow|Tacrolimus / Tacrolimus + Faldaprevir|fixed sequence group 2: single dose of 0.5 mg tac on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 0.5 mg tac on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
674253|NCT02016625|P1|Participant Flow|Cyclosporine / Cyclosporine + Faldaprevir|fixed sequence group 1: single dose of 50 mg cyclo on Day 1 in period 1; treated with FDV 240 mg on Day -7 (loading dose) and 120 mg FDV on Days -6 to 7 and a single dose of 50 mg cyclo on Day 1 in period 2. Mode of administration: oral, with 240 mL water after a meal. A washout period of at least 14 days separated administration of cyclo in the treatment periods.
674254|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
674255|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
674256|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
674257|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7 [followed by tac treatment] in period 2.
674258|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
674259|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by tac treatment] in period 2
674260|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1, treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
674261|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
674262|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
674263|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
674264|NCT02016625|O2|Outcome|Tacrolimus + Faldaprevir|fixed sequence group 2: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 0.5 mg tac on Day 1 in period 2.
674265|NCT02016625|O1|Outcome|Tacrolimus|fixed sequence group 2: treated with tac 0.5 mg on Day 1 in period 1.
674266|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
674267|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
674268|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
674269|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
674270|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
674271|NCT02016625|O1|Outcome|Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 1 [followed by cyclo treatment] in period 2
674272|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
674273|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
674274|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
674275|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
674276|NCT02016625|O2|Outcome|Cyclosporine + Faldaprevir|fixed sequence group 1: treated with FDV 240 mg on Day -7 and 120 mg FDV on Days -6 to 7; single dose of 50 mg cyclo on Day 1 in period 2.
674277|NCT02016625|O1|Outcome|Cyclosporine|fixed sequence group 1: treated with cyclo 50 mg on Day 1 in period 1.
674278|NCT02016625|E6|Reported Event|Tac+FDV|Tacrolimus 0.5 mg + FDV 120 mg
674279|NCT02016625|E5|Reported Event|Cyclo+FDV|Cyclosporine 50 mg + FDV 120 mg
674280|NCT02016625|E4|Reported Event|FDV (ff Tac)|FDV 120 mg (followed by tacrolimus)
674281|NCT02016625|E3|Reported Event|FDV (ff Cyclo)|FDV 120 mg (followed by cyclosporine)
674282|NCT02016625|E2|Reported Event|Tacrolimus (Tac)|Tacrolimus (tac) 0.5 mg
674283|NCT02016625|E1|Reported Event|Cyclosporine (Cyclo)|Cyclosporine (cyclo) 50 mg
674284|NCT02016482|B3|Baseline|Total|Total of all reporting groups
674285|NCT02016482|B2|Baseline|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674286|NCT02016482|B1|Baseline|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674287|NCT02016482|P2|Participant Flow|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674288|NCT02016482|P1|Participant Flow|Placebo|Period A: Placebo subcutaneous every other week (sc eow) for 25 weeks. Period B: Adalimumab (ADA) 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674289|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674290|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
675053|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
674295|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674296|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674297|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674298|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674299|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674300|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674301|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674302|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674303|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674304|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674305|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674306|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674307|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674308|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674309|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674310|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674311|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674312|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674313|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674314|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674315|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674316|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674317|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674318|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674319|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674320|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674321|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674322|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674323|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674324|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674325|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674326|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674327|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674328|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674329|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674330|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674331|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674332|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674333|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674334|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674335|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674336|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674337|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674338|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674339|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674340|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674341|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674342|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674343|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674344|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674345|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674346|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674347|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674348|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674349|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674350|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674351|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674352|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674353|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674354|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674355|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674356|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674357|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674358|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674359|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674360|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674361|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674362|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674363|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674364|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674365|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674366|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674367|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674368|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674369|NCT02016482|O2|Outcome|Adalimumab EOW|Period A: ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg. Period B: Placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674370|NCT02016482|O1|Outcome|Placebo|Period A: Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674371|NCT02016482|E4|Reported Event|Adalimumab EOW/Adalimumab EOW (Period B)|Following Period A (ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg), placebo at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674372|NCT02016482|E3|Reported Event|Placebo/Adalimumab EOW (Period B)|Following Period A (placebo sc eow for 25 weeks), ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674373|NCT02016482|E2|Reported Event|Adalimumab EOW (Period A)|ADA 40 mg sc eow for 25 weeks starting 1 week after initial loading dose of 80 mg.
674374|NCT02016482|E1|Reported Event|Placebo (Period A)|Placebo sc eow for 25 weeks. Period B: ADA 80 mg sc at Week 26 followed by ADA 40 mg sc eow from Week 27 through Week 51.
674375|NCT02016170|B4|Baseline|Total|Total of all reporting groups
674376|NCT02016170|B3|Baseline|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
674377|NCT02016170|B2|Baseline|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
674378|NCT02016170|B1|Baseline|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
674379|NCT02016170|P3|Participant Flow|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
674380|NCT02016170|P2|Participant Flow|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
674381|NCT02016170|P1|Participant Flow|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
674382|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
674383|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
674384|NCT02016170|O2|Outcome|Prasugrel|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7 days
674385|NCT02016170|O1|Outcome|Ticagrelor|Patients switched to ticagrelor (two arms combined) with or without a loading dose and receiving ticagrelor 90 mg bid for 7 days.
674386|NCT02016170|E3|Reported Event|Prasugrel 10mg|Patients already on prasugrel, will maintain prasugrel 10 mg once daily MD for 7±2 days
674387|NCT02016170|E2|Reported Event|Ticagrelor 90mg|Patients on prasugrel will switch to ticagrelor with a 90mg maintenance dose followed by 90 mg BID maintenance dose for 7±2 days
674388|NCT02016170|E1|Reported Event|Ticagrelor 180mg|Patients on prasugrel will switch to ticagrelor with a 180mg loading dose followed by 90 mg BID maintenance dose for 7±2 days.
674389|NCT02016105|B3|Baseline|Total|Total of all reporting groups
674390|NCT02016105|B2|Baseline|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674391|NCT02016105|B1|Baseline|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674392|NCT02016105|P6|Participant Flow|GP2017 Adalimumab Continued|GP2017 subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
674393|NCT02016105|P5|Participant Flow|GP2017 Adalimumab Switched|Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
674394|NCT02016105|P4|Participant Flow|Humira ® Adalimumab Continued|Humira ® subcutaneous (s.c.) injection of 40mg study drug from Week 17 until Week 35 (Treatment Period 2) and from Week 35 until Week 51 (Extension Period).
674395|NCT02016105|P3|Participant Flow|Humira ® Adalimumab Switched|Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35) followed by Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51).
674396|NCT02016105|P2|Participant Flow|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674397|NCT02016105|P1|Participant Flow|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674398|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
675054|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
674522|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674399|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674400|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674401|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674402|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674403|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674404|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674405|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674406|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674407|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674408|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674409|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674410|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674411|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674412|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674413|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674414|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674415|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674416|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674417|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674418|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674419|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
675055|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
674420|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674421|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674422|NCT02016105|O2|Outcome|Humira ® Adalimumab|"Humira® Adalimumab as a subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.~Humira ® Adalimumab"
674423|NCT02016105|O1|Outcome|GP2017 Adalimumab|"Study arm with intervention being studied in the protocol. Adalimumab Solution for subcutaneous injection with an initial dose of 80 mg s.c. in Week 0, followed by 40 mg s.c. eow, starting at Week 1 and ending at Week 51.~GP2017 Adalimumab"
674424|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674425|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674426|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674427|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674428|NCT02016105|O4|Outcome|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674429|NCT02016105|O3|Outcome|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674430|NCT02016105|O2|Outcome|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674431|NCT02016105|O1|Outcome|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674432|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674433|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674434|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674435|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674436|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674437|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674438|NCT02016105|O2|Outcome|Humira ® Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674439|NCT02016105|O1|Outcome|GP2017 Adalimumab|Solution for subcutaneous (s.c.) injection in pre-filled syringe. Study drug is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1).
674440|NCT02016105|E4|Reported Event|GP2017 Adalimumab Continued|GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674441|NCT02016105|E3|Reported Event|GP2017 Adalimumab Switched|"GP2017 is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between Humira ®/GP2017/Humira ® subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~GP2017 40mg subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674518|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674442|NCT02016105|E2|Reported Event|Humira ® Adalimumab Continued|Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose until Week 51.
674443|NCT02016105|E1|Reported Event|Humira ® Adalimumab Switched|"Humira is administered on Day 1 with an intial dose of 80mg followed by 40mg every other week (eow) starting one week after initial dose for the first 17 weeks (Treatment Period 1). Alternating treatment between GP2017/Humira ®/GP2017 subcutaneous (s.c.) injection of 40mg study drug (Treatment Period 2 / Week 17 until Week 35).~Humira ® subcutaneous (s.c.) injection of 40mg study drug (Extension Period / Week 35 until Week 51)."
674444|NCT02015910|B3|Baseline|Total|Total of all reporting groups
674445|NCT02015910|B2|Baseline|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
674446|NCT02015910|B1|Baseline|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
674447|NCT02015910|P2|Participant Flow|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
674448|NCT02015910|P1|Participant Flow|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
674449|NCT02015910|O2|Outcome|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
674450|NCT02015910|O1|Outcome|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
674451|NCT02015910|E2|Reported Event|Placebo|"Placebo~Placebo: Sugar pill manufactured to mimick Sitagliptin 100mg pill."
674452|NCT02015910|E1|Reported Event|Januvia (Sitagliptin)|"Sitagliptin 100 mg a day for 12 weeks~Sitagliptin: Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator"
674453|NCT02015793|B3|Baseline|Total|Total of all reporting groups
674454|NCT02015793|B2|Baseline|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674455|NCT02015793|B1|Baseline|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674456|NCT02015793|P2|Participant Flow|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674457|NCT02015793|P1|Participant Flow|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674458|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674459|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674460|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674461|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674462|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674463|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674464|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674465|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674466|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674467|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674468|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674469|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674470|NCT02015793|O4|Outcome|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
674471|NCT02015793|O3|Outcome|Low Induction Dose (Open-label Extension Period)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
674472|NCT02015793|O2|Outcome|Standard Induction Dose (Double-blind Period)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674473|NCT02015793|O1|Outcome|Low Induction Dose (Double-blind Period)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674474|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674475|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674476|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674477|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674478|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674479|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674480|NCT02015793|O2|Outcome|Standard Induction Dose|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674481|NCT02015793|O1|Outcome|Low Induction Dose|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674482|NCT02015793|E4|Reported Event|Standard Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
674483|NCT02015793|E3|Reported Event|Low Induction Dose (Open-label Extension)|Participants received open-label adalimumab 40 mg every other week for 18 weeks.
674484|NCT02015793|E2|Reported Event|Standard Induction Dose (Double-blind)|Participants received the standard loading dose of adalimumab (160 mg at Week 0 and 80 mg at Week 2) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 4 and 6.
674485|NCT02015793|E1|Reported Event|Low Induction Dose (Double-blind)|Participants received the low loading dose of adalimumab (80 mg at Week 0) followed by the standard maintenance dose of adalimumab (40 mg every other week) at Weeks 2, 4, and 6.
674486|NCT02015676|B4|Baseline|Total|Total of all reporting groups
674487|NCT02015676|B3|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II and II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674488|NCT02015676|B2|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674489|NCT02015676|B1|Baseline|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, from Week 1. If no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
674490|NCT02015676|P3|Participant Flow|Trastuzumab Doxorubicin, Paclitaxel; Phase I and Phase II|During Phase I, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg/m^2, IV, once every 3 weeks, for 2 treatment cycles, then the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19 for 2 treatment cycles, then the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression. In Phase II, participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674491|NCT02015676|P2|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674492|NCT02015676|P1|Participant Flow|Trastuzumab, Doxorubicin, Paclitaxel; Phase I|Participants received an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 40 mg per square meter (mg/m^2), IV, once every 3 weeks, from Week 1. If no dose-limiting toxicity (DLT) was observed in greater than or equal to (≥) two-thirds (2/3) of cohort for 2 treatment cycles, the dose was increased to 50 mg/m^2, IV, and continued for 6 cycles; and paclitaxel 60 mg/m^2, IV, once per week, starting at Week 19; if no DLT was observed in ≥2/3 of cohort for 2 treatment cycles, the dose was increased to 70 mg/m^2, IV, and subsequently 80 mg/m^2, IV, and continued until disease progression.
674519|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674521|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674493|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674494|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674495|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674496|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674497|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674498|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674499|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674500|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674501|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674502|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674503|NCT02015676|O1|Outcome|Trastuzumab, Doxorubicin, Paclitaxel; Phase II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674504|NCT02015676|E1|Reported Event|Trastuzumab, Doxorubicin, Paclitaxel; Phase I & II|Participants received an initial loading dose of trastuzumab 4 mg/kg, IV, over 1.5 hours on Day 1 (Week 1), followed by 2 mg/kg, IV, over 30 minutes once per week from Week 2 to Week 52 or until disease progression; doxorubicin, 50 mg/m^2, IV, once every 3 weeks, starting at Week 1 for 6 cycles; and paclitaxel 80 mg/m^2, IV, once per week, from Week 19 until disease progression.
674505|NCT02015663|B3|Baseline|Total|Total of all reporting groups
674506|NCT02015663|B2|Baseline|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674507|NCT02015663|B1|Baseline|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674508|NCT02015663|P2|Participant Flow|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674509|NCT02015663|P1|Participant Flow|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674510|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674511|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674512|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674513|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674514|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674515|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674516|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674517|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674523|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674524|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674525|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674526|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674527|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674528|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674529|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674530|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674531|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674532|NCT02015663|O2|Outcome|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674533|NCT02015663|O1|Outcome|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674534|NCT02015663|E3|Reported Event|Total Events|
674535|NCT02015663|E2|Reported Event|Tobramycin Inhalation Powder Twice Daily|Tobramycin Inhalation Powder (112 mg) twice daily on days 1-28, days 57-84 and days 113-140
674536|NCT02015663|E1|Reported Event|Tobramycin Inhalation Powder Once Daily|Tobramycin Inhalation Powder (112 mg) once daily during 168 days
674537|NCT02015546|B4|Baseline|Total|Total of all reporting groups
674538|NCT02015546|B3|Baseline|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674539|NCT02015546|B2|Baseline|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674540|NCT02015546|B1|Baseline|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674541|NCT02015546|P3|Participant Flow|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674542|NCT02015546|P2|Participant Flow|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674543|NCT02015546|P1|Participant Flow|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674544|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674545|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674546|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674547|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674548|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674549|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674550|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674551|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674552|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674553|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674554|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674555|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674556|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674557|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674558|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674559|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
675056|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675069|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
674560|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674561|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674562|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674563|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674564|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674565|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674566|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674567|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674568|NCT02015546|O3|Outcome|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674569|NCT02015546|O2|Outcome|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674570|NCT02015546|O1|Outcome|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674571|NCT02015546|E3|Reported Event|Vilazodone 40mg|"vilazodone 40 mg/d arm (40 mg/d initiation and continuation dose for 8-week trial.~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674572|NCT02015546|E2|Reported Event|Vilazodone 20mg|"vilazodone 20 mg arm (20mg/d initiation dose, titrated to 40 mg/d in 1 week, continued for 8-week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674573|NCT02015546|E1|Reported Event|Vilazodone 10mg|"Vilazodone 10 mg/d arm (10mg/d initiation dose, titrated to 40 mg/d in 2 weeks, continued for 8 week trial)~Vilazodone: All subjects will receive Vilazodone at 10, 20 or 40mg."
674574|NCT02015221|B3|Baseline|Total|Total of all reporting groups
674575|NCT02015221|B2|Baseline|Standard Compression Garments|Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.
674576|NCT02015221|B1|Baseline|ACTitouch|ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.
674577|NCT02015221|P2|Participant Flow|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
674578|NCT02015221|P1|Participant Flow|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
674579|NCT02015221|O2|Outcome|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
674580|NCT02015221|O1|Outcome|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
674581|NCT02015221|E2|Reported Event|Standard Compression Garments|"Standard Compression Garments of compression levels 30mmHg to 40mmHg during all waking hours each day.~Standard Compression Garments: Compression stockings with a 30-40mmHg level of compression."
674582|NCT02015221|E1|Reported Event|ACTitouch|"ACTitouch in sustained gradient compression mode during all waking hours (at least 10 hours per day) and intermittent pneumatic compression mode for 2 hours each day.~Dual Action Pneumatic Compression Device: A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet."
674583|NCT02015195|B8|Baseline|Total|Total of all reporting groups
674584|NCT02015195|B7|Baseline|Heated Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Heated Tap Water (40 degrees Celsius)~No treatment~8 males, 8 females treated"
674585|NCT02015195|B6|Baseline|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment~8 makes, 8 females treated"
674586|NCT02015195|B5|Baseline|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~10 males, 6 females treated"
674587|NCT02015195|B4|Baseline|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~1 female treated; adverse local skin reaction; study arm therefore withdrawn"
674588|NCT02015195|B3|Baseline|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~9 males, 7 females treated"
674589|NCT02015195|B2|Baseline|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~8 males, 8 females treated"
674648|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674590|NCT02015195|B1|Baseline|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~11 males, 5 females treated"
674591|NCT02015195|P7|Participant Flow|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
674592|NCT02015195|P6|Participant Flow|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment).~No treatment"
674593|NCT02015195|P5|Participant Flow|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
674594|NCT02015195|P4|Participant Flow|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
674595|NCT02015195|P3|Participant Flow|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
674596|NCT02015195|P2|Participant Flow|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
674597|NCT02015195|P1|Participant Flow|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment~The left arm was always the active treatment arm; the right arm was the control arm (i.e., no treatment)."
674598|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
674599|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
674600|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
674601|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
674602|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
674603|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
674604|NCT02015195|O6|Outcome|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
674605|NCT02015195|O5|Outcome|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
674606|NCT02015195|O4|Outcome|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
674607|NCT02015195|O3|Outcome|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
674608|NCT02015195|O2|Outcome|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
674609|NCT02015195|O1|Outcome|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
674610|NCT02015195|E7|Reported Event|Hot Water (40 Degrees Celsius)|"Hot Tap Water (40 degrees Celsius) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Hot Tap Water (40 degrees Celsius)~No treatment"
674611|NCT02015195|E6|Reported Event|Isopropyl Alcohol (70%)|"Isopropyl Alcohol (70%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Isopropyl Alcohol (70%)~No treatment"
674612|NCT02015195|E5|Reported Event|Lidocaine (4%)|"Lidocaine (4%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Lidocaine (4%)~No treatment"
674613|NCT02015195|E4|Reported Event|Household Ammonia (10%)|"Ammonia (10%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Ammonia (10%)~No treatment~The first patient treated had an adverse local skin reaction, so this study arm was discontinued"
674614|NCT02015195|E3|Reported Event|Papain Slurry (70%)|"Papain Slurry (70%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Papain Slurry (70%)~No treatment"
674615|NCT02015195|E2|Reported Event|Sodium Bicarbonate Slurry (50%)|"Sodium Bicarbonate Slurry (50%) Dosage form: Liquid slurry Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Sodium Bicarbonate Slurry (50%)~No treatment"
674616|NCT02015195|E1|Reported Event|Acetic Acid 5%|"Acetic Acid (5%) Dosage form: Liquid Dosage: 5 ml topical Frequency: every 2 minutes Duration: 30 minutes~Acetic Acid (5%)~No treatment"
674617|NCT02014584|B3|Baseline|Total|Total of all reporting groups
674618|NCT02014584|B2|Baseline|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674619|NCT02014584|B1|Baseline|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674649|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
675057|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675058|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
674620|NCT02014584|P6|Participant Flow|Targeted F/U: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study drug administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
674621|NCT02014584|P5|Participant Flow|Targeted F/U: Placebo (DB)/Dutasteride 0.5 mg (OL)|Participants with an ongoing AE related to sexual function at the end of the treatment Period and participants who discontinued study treatment due to an AE related to sexual function entered a Targeted Follow-Up Period (no study treatment administered) lasting until 24 weeks after the last dose of study treatment or until resolution of the sexual AE, whichever occurred first.
674622|NCT02014584|P4|Participant Flow|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674623|NCT02014584|P3|Participant Flow|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674624|NCT02014584|P2|Participant Flow|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674625|NCT02014584|P1|Participant Flow|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674626|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674627|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674628|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674629|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674630|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674631|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674632|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674633|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674634|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674635|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674636|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674637|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674638|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674639|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674640|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674641|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674642|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674643|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674644|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674645|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674646|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674647|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674650|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674651|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674652|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674653|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674654|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674655|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674656|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674657|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674658|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674659|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674660|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674661|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674662|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674663|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674664|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674665|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674666|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674667|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674668|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674669|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674670|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674671|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674672|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674673|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674674|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674675|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674676|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674677|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674678|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674679|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674682|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674683|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674684|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674685|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674686|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674687|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674688|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674689|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674690|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674691|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674692|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674693|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674694|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674695|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674696|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674697|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674698|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674699|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674700|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674701|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674702|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674703|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674704|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674705|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674706|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674707|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674708|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674709|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674710|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674711|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674712|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674713|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674714|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674715|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674716|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674717|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674718|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674719|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674720|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674721|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674722|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674723|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674724|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674725|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674726|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674727|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674728|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674729|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674730|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674731|NCT02014584|O1|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674732|NCT02014584|O2|Outcome|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period, participants received dutasteride 0.5 mg administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period continued to receive dutasteride 0.5 mg once daily for the second 24-week treatment period.
674733|NCT02014584|O1|Outcome|Placebo (DB)/Dutasteride 0.5 mg (OL)|During double-blind treatment period participants received placebo administered orally once daily for 24 weeks. All participants completing the first 24-week treatment period received dutasteride 0.5 mg once daily for the second 24-week treatment period.
674734|NCT02014584|O2|Outcome|Dutasteride 0.5 mg|Participants received dutasteride 0.5 mg administered orally once daily for 24 weeks.
674735|NCT02014584|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 24 weeks.
674736|NCT02014584|E5|Reported Event|Combined: Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
674737|NCT02014584|E4|Reported Event|Dutasteride 0.5 mg (DB)/Dutasteride 0.5 mg (OL)|
674738|NCT02014584|E3|Reported Event|Placebo (DB)/Dutasteride 0.5 mg (OL)|
674739|NCT02014584|E2|Reported Event|Dutasteride 0.5 mg (DB)|
674740|NCT02014584|E1|Reported Event|Placebo (DB)|
674741|NCT02014480|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
674742|NCT02014480|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
674743|NCT02014480|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
674744|NCT02014480|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
674745|NCT02014480|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
674746|NCT02014480|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
674747|NCT02014480|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol trifenatate (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
674748|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674749|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674750|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674751|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674752|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674753|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674754|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674755|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674756|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674757|NCT02014480|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674758|NCT02014480|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674759|NCT02014480|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674760|NCT02014480|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674761|NCT02014480|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674762|NCT02014480|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
674763|NCT02014467|B3|Baseline|Total|Total of all reporting groups
674764|NCT02014467|B2|Baseline|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674765|NCT02014467|B1|Baseline|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674766|NCT02014467|P2|Participant Flow|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase.Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674767|NCT02014467|P1|Participant Flow|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674768|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674769|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674770|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674771|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674772|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674773|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674774|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674775|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674776|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674777|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674778|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674779|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674780|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674781|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674782|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674783|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674784|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674785|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674786|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674787|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674788|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674789|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674790|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
675059|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
674791|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674792|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674793|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674794|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674795|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674796|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674797|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674798|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674799|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674800|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674801|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674802|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674803|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674804|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674805|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674806|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674807|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674808|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674809|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674810|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674811|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674812|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674813|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
675060|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
674814|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674815|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674816|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674817|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674818|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674819|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674820|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674821|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674822|NCT02014467|O2|Outcome|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674823|NCT02014467|O1|Outcome|Denosumab 60 mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674824|NCT02014467|E2|Reported Event|Placebo|Participants received single SC injection of placebo at Baseline and Month 6 during the Double-blind Treatment Phase. Participants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 IU).
674825|NCT02014467|E1|Reported Event|Denosumab 60mg|Participants received single subcutaneous (SC) injection of denosumab 60 milligrams (mg) at Baseline and Month 6 during the Double-blind Treatment Phase. Particpants also received daily oral supplementation of elemental calcium (at least 600 mg) and vitamin D (at least 400 international unit [IU]).
674826|NCT02014441|B1|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674827|NCT02014441|P1|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674828|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674829|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674830|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674831|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674832|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674833|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674834|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674835|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674836|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674838|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674839|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674840|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674841|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674842|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674843|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674844|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674845|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674846|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674847|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674848|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674849|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674850|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674851|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674852|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674853|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674854|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674855|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674856|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674857|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674858|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674859|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674860|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674861|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674862|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674863|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674864|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674865|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674866|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674867|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674868|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674869|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674870|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674871|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674872|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
709112|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
674874|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674875|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674876|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674877|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674878|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674879|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674880|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674881|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674882|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674883|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674884|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674885|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674886|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674887|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674888|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674889|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674890|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674891|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674892|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674893|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674894|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674895|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674896|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674897|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674898|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674899|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674900|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674901|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674902|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674903|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674904|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674905|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674906|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674907|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674908|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
709113|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
674910|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674911|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674912|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674913|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674914|NCT02014441|O3|Outcome|Talimogene Laherparepvec: HSV-1 Positive|Participants who were seropositive at baseline for HSV-1.
674915|NCT02014441|O2|Outcome|Talimogene Laherparepvec: HSV-1 Negative|Participants who were seronegative at baseline for HSV-1.
674916|NCT02014441|O1|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674917|NCT02014441|E1|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
674918|NCT02014402|B5|Baseline|Total|Total of all reporting groups
674919|NCT02014402|B4|Baseline|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674920|NCT02014402|B3|Baseline|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674921|NCT02014402|B2|Baseline|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674922|NCT02014402|B1|Baseline|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674923|NCT02014402|P4|Participant Flow|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674924|NCT02014402|P3|Participant Flow|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674925|NCT02014402|P2|Participant Flow|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674926|NCT02014402|P1|Participant Flow|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674927|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674928|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674929|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674930|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674931|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674932|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674933|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674934|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674935|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674936|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674937|NCT02014402|O5|Outcome|Overall (IG1202-A, IG1202-B, IG1202-C, and IG1202-D)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674938|NCT02014402|O4|Outcome|IG1202-D (Spinal)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674939|NCT02014402|O3|Outcome|IG1202-C (Soft Tissue)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674940|NCT02014402|O2|Outcome|IG1202-B (Hepatic)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674941|NCT02014402|O1|Outcome|IG1202-A (Vascular)|"Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges~Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges"
674942|NCT02014402|E10|Reported Event|Overall (IG1202-A, -B, -C, and -D): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674943|NCT02014402|E9|Reported Event|Overall (IG1202-A, -B, -C, and -D): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674944|NCT02014402|E8|Reported Event|IG1202-D (Spinal): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674945|NCT02014402|E7|Reported Event|IG1202-D (Spinal): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674946|NCT02014402|E6|Reported Event|IG1202-C (Soft Tissue): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674947|NCT02014402|E5|Reported Event|IG1202-C (Soft Tissue): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674948|NCT02014402|E4|Reported Event|IG1202-B (Hepatic): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674949|NCT02014402|E3|Reported Event|IG1202-B (Hepatic): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674950|NCT02014402|E2|Reported Event|IG1202-A (Vascular): Bovine Thrombin|Bovine thrombin: Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674951|NCT02014402|E1|Reported Event|IG1202-A (Vascular): Human Thrombin|Human thrombin: Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
674952|NCT02014363|B4|Baseline|Total|Total of all reporting groups
674953|NCT02014363|B3|Baseline|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
674954|NCT02014363|B2|Baseline|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
674955|NCT02014363|B1|Baseline|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
674956|NCT02014363|P3|Participant Flow|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
674957|NCT02014363|P2|Participant Flow|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
674958|NCT02014363|P1|Participant Flow|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
674959|NCT02014363|O3|Outcome|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
674960|NCT02014363|O2|Outcome|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
674961|NCT02014363|O1|Outcome|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
674962|NCT02014363|E3|Reported Event|Amitriptyline|"Amitriptyline tablets (encapsulated) Standard dosing regime~Amitriptyline"
674963|NCT02014363|E2|Reported Event|ETS6103 (High Dose)|"ETS6103 (high dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (high dose)"
674964|NCT02014363|E1|Reported Event|ETS6103 (Low Dose)|"ETS6103 (low dose) extended release tablets (encapsulated) taken once daily orally for the duration of randomised phase of the study (8 weeks).~ETS6103 (low dose)"
674965|NCT02014272|B1|Baseline|Entire Study Population|Includes all participants randomized to receive RIN 150 first and rifampicin and isoniazid first.
675061|NCT02013687|E4|Reported Event|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
674966|NCT02014272|P2|Participant Flow|Rifampicin and Isoniazid First, Then RIN 150|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in first intervention period followed by single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
674967|NCT02014272|P1|Participant Flow|RIN 150 First, Then Rifampicin and Isoniazid|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contained 150 milligram [mg] rifampicin and 75 mg isoniazid) on Day 1 in first intervention period, followed by single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in second intervention period. A washout period of at least 7 days was maintained between each intervention period.
674968|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674969|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674970|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674971|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674972|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674973|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674974|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674975|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674976|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674977|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674978|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674979|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674980|NCT02014272|O2|Outcome|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674981|NCT02014272|O1|Outcome|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674982|NCT02014272|E2|Reported Event|Rifampicin and Isoniazid|Single oral dose of 4 rifampicin 150 mg capsules and 3 isoniazid 100 mg tablets on Day 1 in either of the 2 intervention periods.
674983|NCT02014272|E1|Reported Event|RIN 150|Single oral dose of 4 fixed dose combination (FDC) tablets of RIN 150 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) on Day 1 in either of the 2 intervention periods.
674984|NCT02014051|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
674985|NCT02014051|P2|Participant Flow|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674986|NCT02014051|P1|Participant Flow|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674987|NCT02014051|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB C-1101 either at 280 mg/dose or 560 mg/dose orally.
674988|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674989|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674990|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674991|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
675062|NCT02013687|E3|Reported Event|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
674992|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674993|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674994|NCT02014051|O2|Outcome|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674995|NCT02014051|O1|Outcome|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674996|NCT02014051|E2|Reported Event|SyB C-1101 560 mg/Dose Group|"Cohort 2: Participants were administered 560 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674997|NCT02014051|E1|Reported Event|SyB C-1101 280 mg/Dose Group|"Cohort 1: Participants were administered 280 mg/dose of SyB C-1101 twice daily orally for 14 consecutive days, followed by 7-day observation period.~The treatment period of 21 days constitutes 1 cycle, and the treatment was allowed for up to cycles.~The participants received SyB C-1101 only once daily on Day 1 and Day 14 of Cycle 1 for the investigation of the pharmacokinetics."
674998|NCT02013830|B1|Baseline|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
674999|NCT02013830|P1|Participant Flow|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 milligrams per kilogram (mg/kg) bevacizumab intravenously (IV) on Day 1; and 1600 mg per square meter per day (mg/m^2/day) capecitabine tablets, orally (PO), in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675000|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675001|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675002|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675003|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675004|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675063|NCT02013687|E2|Reported Event|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675064|NCT02013687|E1|Reported Event|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675065|NCT02013622|B1|Baseline|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675068|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675005|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675006|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675007|NCT02013830|O1|Outcome|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675008|NCT02013830|E1|Reported Event|Bevacizumab/Capecitabine|A cycle was defined as the following: Participants received 7.5 mg/kg bevacizumab IV on Day 1 and 1600 mg/m^2/day capecitabine, tablets, PO, in a divided dose every 12 hours starting the evening of Day 1 and ending on the morning of Day 15, followed by 1 week of no treatment. This cycle was repeated every 3 weeks until disease progression, development of unacceptable toxicity, or for a maximum of 6 cycles. If all 6 cycles were tolerated without disease progression or development of unacceptable toxicity, participants then could have repeated the cycle until disease progression.
675009|NCT02013817|B1|Baseline|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675010|NCT02013817|P1|Participant Flow|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675011|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675012|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675013|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675014|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675066|NCT02013622|P1|Participant Flow|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 milligram per day (mg/day) to 4 mg/day, once daily (QD) for 16 Weeks.
675067|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675015|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675016|NCT02013817|O1|Outcome|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675017|NCT02013817|E1|Reported Event|Rituximab, Fludarabine, Cyclophosphamide|"Induction Phase Cycle 1 (4-week cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3 and rituximab 375 mg/m^2 IV on Day 4.~Induction Phase Cycles 2 and 3 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1-3~Induction Phase Cycles 4 to 6 (4-week cycles): Participants received rituximab 500 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV on Days 1-5.~Maintenance Phase (Cycles 1-8; 12-week cycles): 8 weeks after the end of the last induction cycle, participants received maintenance therapy with rituximab 375 mg/m^2, IV once every 12 weeks for a total of 8 infusions (maximum 2 years)."
675018|NCT02013765|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675019|NCT02013765|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675020|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675021|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675022|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675023|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675024|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675025|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675026|NCT02013765|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675027|NCT02013765|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by weekly doses of 2 mg/kg, IV, beginning on Day 8 until tumor progression, unacceptable toxicity, participant withdrawal, or termination by sponsor.
675028|NCT02013687|B5|Baseline|Total|Total of all reporting groups
675029|NCT02013687|B4|Baseline|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675030|NCT02013687|B3|Baseline|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675031|NCT02013687|B2|Baseline|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675032|NCT02013687|B1|Baseline|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675033|NCT02013687|P4|Participant Flow|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675034|NCT02013687|P3|Participant Flow|30 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675035|NCT02013687|P2|Participant Flow|10 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675036|NCT02013687|P1|Participant Flow|2 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675037|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675038|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675039|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675040|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675041|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675042|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675043|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675044|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675045|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675046|NCT02013687|O3|Outcome|30 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675047|NCT02013687|O2|Outcome|10 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675048|NCT02013687|O1|Outcome|2 µg + Alhydrogel|Pfs25 VLP-FhCMB vaccine
675049|NCT02013687|O4|Outcome|100 µg + Alhydrogel|Pfs25 VLP- FhCMB vaccine
675070|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675071|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675072|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675073|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675074|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675075|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675076|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675077|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675078|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675079|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675080|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675081|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675082|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675083|NCT02013622|O1|Outcome|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675084|NCT02013622|E1|Reported Event|Brexpiprazole|Participants received oral brexpiprazole tablets of 1 mg/day to 4 mg/day, QD for 16 Weeks.
675085|NCT02013609|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675086|NCT02013609|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 milligram per day (mg/day) for the first week with titration up to 3 mg/day once daily (QD) in addition to their constant-dose antidepressant therapy (ADT) for 12 weeks.
675087|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675088|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675089|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675090|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675091|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675092|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675093|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675094|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675095|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675096|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675097|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675098|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675099|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675100|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675101|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675102|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675103|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675104|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675105|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675196|NCT02013388|E8|Reported Event|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
675197|NCT02013388|E7|Reported Event|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
675106|NCT02013609|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675107|NCT02013609|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablet of 0.5 mg/day for the first week with titration up to 3 mg/day QD in addition to their constant-dose ADT for 12 weeks.
675108|NCT02013544|B3|Baseline|Total|Total of all reporting groups
675109|NCT02013544|B2|Baseline|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675110|NCT02013544|B1|Baseline|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675111|NCT02013544|P2|Participant Flow|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675112|NCT02013544|P1|Participant Flow|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks
675113|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675114|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675115|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675116|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675117|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675118|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675119|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675120|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675121|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675122|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675123|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675124|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675125|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675126|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675127|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675128|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675129|NCT02013544|O2|Outcome|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks.
675130|NCT02013544|O1|Outcome|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675131|NCT02013544|E2|Reported Event|0.50% Prasterone (DHEA)|Prasterone (DHEA): Vaginal ovule containing 0.50% (6.5 mg) prasterone; daily dosing with one ovule for 12 weeks
675132|NCT02013544|E1|Reported Event|Placebo|Placebo: Placebo vaginal ovule; daily dosing with one ovule for 12 weeks.
675133|NCT02013531|B1|Baseline|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675134|NCT02013531|P1|Participant Flow|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 milligram per day (mg/day) with titration up to 3 mg/day once daily (QD) in addition to their constant-dose ADT (anti-depressant therapy) for 6 weeks.
675135|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675136|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675137|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675138|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675139|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675140|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675141|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675142|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675143|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675144|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675145|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675146|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675272|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
675147|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675148|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675149|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675150|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675151|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675152|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675153|NCT02013531|O1|Outcome|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day with titration up to 3 mg/day QD in addition to their constant-dose ADT for 6 weeks.
675154|NCT02013531|E1|Reported Event|Brexpiprazole|Participants were administered oral brexpiprazole tablets of 0.5 mg/day to 3 mg/day, QD for 6 weeks.
675155|NCT02013388|B9|Baseline|Total|Total of all reporting groups
675156|NCT02013388|B8|Baseline|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
675157|NCT02013388|B7|Baseline|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
675158|NCT02013388|B6|Baseline|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
675159|NCT02013388|B5|Baseline|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675160|NCT02013388|B4|Baseline|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675161|NCT02013388|B3|Baseline|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675162|NCT02013388|B2|Baseline|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675163|NCT02013388|B1|Baseline|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
675164|NCT02013388|P8|Participant Flow|Placebo-single Dose|Placebo: Given PO daily for 1 day
675165|NCT02013388|P7|Participant Flow|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
675166|NCT02013388|P6|Participant Flow|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
675167|NCT02013388|P5|Participant Flow|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675168|NCT02013388|P4|Participant Flow|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675169|NCT02013388|P3|Participant Flow|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675170|NCT02013388|P2|Participant Flow|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675171|NCT02013388|P1|Participant Flow|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
675172|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675173|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675174|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675175|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675176|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675177|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675178|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675179|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675180|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675181|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675182|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675183|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675184|NCT02013388|O4|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675185|NCT02013388|O3|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675186|NCT02013388|O2|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675187|NCT02013388|O1|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675188|NCT02013388|O8|Outcome|Placebo- Single Dose|single oral dose Placebo: Given PO daily for 1day
675189|NCT02013388|O7|Outcome|250 mg (Fed)|"single oral daily dose of 250 mg N91115 for 1 day (fed fat meal)~N91115: Given PO only on Day 1"
675190|NCT02013388|O6|Outcome|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
675191|NCT02013388|O5|Outcome|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675192|NCT02013388|O4|Outcome|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675193|NCT02013388|O3|Outcome|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675194|NCT02013388|O2|Outcome|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675195|NCT02013388|O1|Outcome|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
709114|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
675198|NCT02013388|E6|Reported Event|50 mg (Single Dose)|"single oral dose of 50 mg N91115~N91115: Given PO only on Day 1"
675199|NCT02013388|E5|Reported Event|500 mg|"single oral daily dose of 500 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675200|NCT02013388|E4|Reported Event|250 mg|"single oral daily dose of 250 mg N91115 for 14 days (fasted)~N91115: Given PO daily for 14 days"
675201|NCT02013388|E3|Reported Event|50 mg|"single oral daily dose of 50 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675202|NCT02013388|E2|Reported Event|10 mg|"single oral daily dose of 10 mg N91115 for 14 days~N91115: Given PO daily for 14 days"
675203|NCT02013388|E1|Reported Event|Placebo|"single oral daily dose of placebo for 14 days~Placebo: Given PO daily for 14 days"
675204|NCT02013245|B5|Baseline|Total|Total of all reporting groups
675205|NCT02013245|B4|Baseline|BCG Control Group|BCG standard dose group (5 x 10^5 CFU BCG)
675206|NCT02013245|B3|Baseline|Group 3|MTBVAC high dose group (5 x 10^5 CFU MTBVAC)
675207|NCT02013245|B2|Baseline|Group 2|MTBVAC intermediate dose group (5 x 10^4 CFU MTBVAC)
675208|NCT02013245|B1|Baseline|Group 1|MTBVAC low dose group (5 x 10^3 CFU MTBVAC)
675209|NCT02013245|P4|Participant Flow|BCG Control Group|Intervention: Commercially available BCG live vaccine (dose 5 x 10^5 CFU)
675210|NCT02013245|P3|Participant Flow|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
675211|NCT02013245|P2|Participant Flow|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
675212|NCT02013245|P1|Participant Flow|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
675213|NCT02013245|O4|Outcome|BCG Control Group|Intervention: Commercially available BCg live vaccine (standard dose 5 x 10^5 CFU)
675214|NCT02013245|O3|Outcome|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
675215|NCT02013245|O2|Outcome|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
675216|NCT02013245|O1|Outcome|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
675217|NCT02013245|O4|Outcome|BCG Control Group|Intervention: Commercially available BCg live vaccine (standard dose 5 x 10^5 CFU)
675218|NCT02013245|O3|Outcome|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
675219|NCT02013245|O2|Outcome|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
675220|NCT02013245|O1|Outcome|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
675221|NCT02013245|E4|Reported Event|BCG Control Group|Intervention: Commercially available BCG live vaccine (standard dose 5 x 10^5 CFU)
675222|NCT02013245|E3|Reported Event|MTBVAC Group 3|Intervention: MTBVAC live vaccine (high dose 5 x 10^5 CFU)
675223|NCT02013245|E2|Reported Event|MTBVAC Group 2|Intervention: MTBVAC live vaccine (middle dose 5 x 10^4 CFU)
675224|NCT02013245|E1|Reported Event|MTBVAC Group 1|Intervention: MTBVAC live vaccine (low dose 5 x 10^3 CFU)
675225|NCT02013206|B3|Baseline|Total|Total of all reporting groups
675226|NCT02013206|B2|Baseline|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675227|NCT02013206|B1|Baseline|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675228|NCT02013206|P2|Participant Flow|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675229|NCT02013206|P1|Participant Flow|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675230|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675231|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675232|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675233|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675234|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675235|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675273|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675274|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675236|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675237|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675238|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675239|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675240|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675241|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675242|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675243|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675244|NCT02013206|O2|Outcome|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675245|NCT02013206|O1|Outcome|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675246|NCT02013206|E2|Reported Event|Never Smokers|Never Smokers (participants who smoked ≤ 100 cigarettes in entire lifetime or had never smoked cigarettes) received erlotinib [Tarceva] 150 mg orally daily until disease progression or unacceptable toxicity.
675247|NCT02013206|E1|Reported Event|Current/Former Smokers|Current Smokers (participants who smoked > 100 cigarettes in entire lifetime and either quit smoking < 1 year ago or were currently smoking) or Former Smokers (participants who smoked > 100 cigarettes in entire lifetime and quit smoking ≥ 1 year ago) received erlotinib [Tarceva] 150 mg orally daily, increasing to a maximum of 300 mg orally daily until disease progression or unacceptable toxicity.
675248|NCT02012686|B3|Baseline|Total|Total of all reporting groups
675249|NCT02012686|B2|Baseline|TENS Group|numerical rating scale of TENS applied group
675250|NCT02012686|B1|Baseline|Control Group|numerical rating scale of TENS non-applied group
675251|NCT02012686|P2|Participant Flow|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
675252|NCT02012686|P1|Participant Flow|Control Group|numerical rating scale of TENS non-applied group
675253|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
675254|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
675255|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
675256|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
675257|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
675258|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
675259|NCT02012686|O2|Outcome|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
675260|NCT02012686|O1|Outcome|Control Group|numerical rating scale of TENS non-applied group
675261|NCT02012686|E2|Reported Event|TENS Group|"numerical rating scale of TENS applied group~TENS: transcutaneous electric nerve stimulation"
675262|NCT02012686|E1|Reported Event|Control Group|numerical rating scale of TENS non-applied group
675263|NCT02012582|B5|Baseline|Total|Total of all reporting groups
675264|NCT02012582|B4|Baseline|Placebo|"0.9 % Sodium chloride infusion~Saline"
675265|NCT02012582|B3|Baseline|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675266|NCT02012582|B2|Baseline|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675267|NCT02012582|B1|Baseline|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675268|NCT02012582|P4|Participant Flow|Placebo|"0.9 % Sodium chloride infusion~Placebo"
675269|NCT02012582|P3|Participant Flow|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675270|NCT02012582|P2|Participant Flow|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675271|NCT02012582|P1|Participant Flow|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675275|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675276|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
675277|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675278|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675279|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675280|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
675281|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675282|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675283|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675284|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
675285|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675286|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675287|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675288|NCT02012582|O4|Outcome|Placebo|"0.9 % Sodium chloride infusion~Placebo"
675289|NCT02012582|O3|Outcome|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675290|NCT02012582|O2|Outcome|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675291|NCT02012582|O1|Outcome|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675292|NCT02012582|E4|Reported Event|Placebo|"0.9 % Sodium chloride infusion~Placebo"
675293|NCT02012582|E3|Reported Event|VAS203 30 mg/kg|"10 mg/kg/24 hours, 72 hour continuous infusion. Total dose: 30 mg/kg~VAS203"
675294|NCT02012582|E2|Reported Event|VAS203 20 mg/kg|"10 mg/kg/24 hours, 48 hour continuous infusion. Total dose: 20 mg/kg~VAS203"
675295|NCT02012582|E1|Reported Event|VAS203 15 mg/kg|"Three 5 mg/kg/12-hours infusion with 12 hours break after each infusion. Total dose: 15 mg/kg~VAS203"
675296|NCT02012452|B3|Baseline|Total|Total of all reporting groups
675297|NCT02012452|B2|Baseline|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
675298|NCT02012452|B1|Baseline|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
675299|NCT02012452|P2|Participant Flow|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
675300|NCT02012452|P1|Participant Flow|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
675301|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
675302|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
675303|NCT02012452|O2|Outcome|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
675304|NCT02012452|O1|Outcome|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
675305|NCT02012452|E2|Reported Event|Health Education Treatment|"Participants will be provided education on a variety of health topics and will set health goals around each topic~Health Education: Participants will be provided education on a variety of health topics and will set health goals around each topic"
675306|NCT02012452|E1|Reported Event|Tobacco Treatment|"participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment~Tobacco treatment: participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment"
675307|NCT02012218|B6|Baseline|Total|Total of all reporting groups
675308|NCT02012218|B5|Baseline|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675309|NCT02012218|B4|Baseline|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675335|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
675336|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
675337|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
675310|NCT02012218|B3|Baseline|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675311|NCT02012218|B2|Baseline|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675312|NCT02012218|B1|Baseline|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675313|NCT02012218|P5|Participant Flow|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675314|NCT02012218|P4|Participant Flow|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675315|NCT02012218|P3|Participant Flow|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675316|NCT02012218|P2|Participant Flow|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675317|NCT02012218|P1|Participant Flow|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675318|NCT02012218|O5|Outcome|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675319|NCT02012218|O4|Outcome|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675320|NCT02012218|O3|Outcome|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675321|NCT02012218|O2|Outcome|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675322|NCT02012218|O1|Outcome|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675323|NCT02012218|E5|Reported Event|Group 4|Participants who had received a prescribed number of tablets of stimulants such as modafinil, methylphenidate, or psychostimulant (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675324|NCT02012218|E4|Reported Event|Group 3|Participants who had received a prescribed number of tablets of bupropion (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675325|NCT02012218|E3|Reported Event|Group 2|Participants who had received a prescribed number of tablets of any Selective Serotonin Reuptake Inhibitors (SSRI), any Serotonin-norepinephrine Reuptake Inhibitors (SNRI), any tricyclic antidepressant, or Oleptro (trazodone hydrochloride) IR or XR (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675326|NCT02012218|E2|Reported Event|Group 1B|Participants who had received a prescribed number of tablets of quetiapine IR (immediate release) or XR (extended release) (baseline/primary ADT) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675327|NCT02012218|E1|Reported Event|Group 1A|Participants who had received a prescribed number of tablets of aripiprazole (baseline/primary antidepressant therapy [ADT]) and adjunctive therapy were switched to ADT plus one tablet of brexpiprazole as adjunctive therapy daily throughout the 6-week treatment period.
675328|NCT02011893|B1|Baseline|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
675329|NCT02011893|P3|Participant Flow|Arm 2|Burst stimulation first, then Tonic
675330|NCT02011893|P2|Participant Flow|Arm 1|Tonic stimulation first, then Burst
675331|NCT02011893|P1|Participant Flow|Enrolled|All subjects enrolled through device activation/randomization
675332|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
675333|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
675334|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
676271|NCT02006732|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
675338|NCT02011893|O2|Outcome|Tonic Stimulation|"Tonic Stimulation using the Prodigy system~Tonic Stimulation: Prodigy Neurostimulation System with associated components"
675339|NCT02011893|O1|Outcome|Burst Stimulation|"Burst Stimulation using the Prodigy system~Burst Stimulation: Prodigy Neurostimulation System with associated components"
675340|NCT02011893|E1|Reported Event|All Subjects|All subjects who were enrolled in the SUNBURST clinical study
675341|NCT02011516|B3|Baseline|Total|Total of all reporting groups
675342|NCT02011516|B2|Baseline|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
675343|NCT02011516|B1|Baseline|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
675344|NCT02011516|P2|Participant Flow|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
675345|NCT02011516|P1|Participant Flow|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
675346|NCT02011516|O2|Outcome|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
675347|NCT02011516|O1|Outcome|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
675348|NCT02011516|E2|Reported Event|Baclofen, Psychosocial Intervention|"20 mg. q.i.d. twice weekly appointments with a certified clinician~Baclofen~Psychosocial"
675349|NCT02011516|E1|Reported Event|Sugar Pill, Psychosocial Intervention|"twice weekly appointments with a certified clinician~Psychosocial~Placebo"
675350|NCT02011490|B4|Baseline|Total|Total of all reporting groups
675351|NCT02011490|B3|Baseline|Healthy Control Participants: Part 1 + Part 2|This group includes healthy control participants who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
675352|NCT02011490|B2|Baseline|Moderate Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with moderate renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
675353|NCT02011490|B1|Baseline|Severe Renal Insufficiency Participants: Part 1 + Part 2|This group includes participants with severe renal insufficiency who were included in Part 1, Part 2, or in both Part 1 and Part 2. Participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port.
675354|NCT02011490|P6|Participant Flow|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675355|NCT02011490|P5|Participant Flow|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675356|NCT02011490|P4|Participant Flow|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675357|NCT02011490|P3|Participant Flow|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675358|NCT02011490|P2|Participant Flow|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675359|NCT02011490|P1|Participant Flow|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an intravenous (IV) bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675360|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675361|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675381|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
676272|NCT02006732|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676079|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
675362|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675363|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675364|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675365|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675366|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675367|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675368|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675369|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675370|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675371|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675372|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675373|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675374|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675375|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675376|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675377|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675378|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675379|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675380|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675382|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675383|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675384|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675385|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675386|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675387|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675388|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675389|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675390|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675391|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675392|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675393|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675394|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675395|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675396|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675397|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675398|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675399|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675400|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
676003|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
675401|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675402|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675403|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675404|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675405|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675406|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675407|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675408|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675409|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675410|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675411|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675412|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675413|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675414|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675415|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675416|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675417|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675418|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675419|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
676267|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
675420|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675421|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675422|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675423|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675424|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675425|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675426|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675427|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675428|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675429|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675430|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675431|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675432|NCT02011490|O6|Outcome|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675433|NCT02011490|O5|Outcome|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675434|NCT02011490|O4|Outcome|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675435|NCT02011490|O3|Outcome|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675436|NCT02011490|O2|Outcome|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675437|NCT02011490|O1|Outcome|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675438|NCT02011490|E6|Reported Event|Healthy Control Participants: Part 2|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675439|NCT02011490|E5|Reported Event|Moderate Renal Insufficiency Participants: Part 2|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675440|NCT02011490|E4|Reported Event|Severe Renal Insufficiency Participants: Part 2|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 2, dose is administered into a peripheral vein through an IV catheter connected to an IV tubing with injection port. The IV tubing is connected to a saline bag. Free-flowing access to the vein is confirmed immediately prior to dose administration, and dose is followed by saline flush.
675441|NCT02011490|E3|Reported Event|Healthy Control Participants: Part 1|Healthy control participants receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675442|NCT02011490|E2|Reported Event|Moderate Renal Insufficiency Participants: Part 1|Participants with moderate renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675443|NCT02011490|E1|Reported Event|Severe Renal Insufficiency Participants: Part 1|Participants with severe renal insufficiency receive a single dose of 4 mg/kg sugammadex administered as an IV bolus over 10 seconds. In Part 1, dose is administered by direct injection into a peripheral vein.
675444|NCT02011113|B1|Baseline|Pomalidomide Plus Dexamethasone|Pomalidomide: 4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle Dexamethasone: 40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
675445|NCT02011113|P1|Participant Flow|Pomalidomide Plus Dexamethasone|Pomalidomide 4 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Dexamethasone 40 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are ≤ 75 years of age Dexamethasone 20 mg PO once daily on Days 1, 8, 15, 22 of each 28-day cycle for those who are > 75 years of age
675446|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
675447|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675448|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675449|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675450|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675451|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675452|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675453|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675454|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675455|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675456|NCT02011113|O1|Outcome|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
675457|NCT02011113|E1|Reported Event|Pomalidomide Plus Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression or pomalidomide discontinuation for any reason.
675458|NCT02010996|B3|Baseline|Total|Total of all reporting groups
675459|NCT02010996|B2|Baseline|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
675460|NCT02010996|B1|Baseline|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
675461|NCT02010996|P2|Participant Flow|Axillary Dissection|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
675462|NCT02010996|P1|Participant Flow|Vacuum Assisted Closure|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
675463|NCT02010996|O4|Outcome|Axillary Dissection(Shank)|
675464|NCT02010996|O3|Outcome|Vacuum Assisted Closure(Shank)|
675465|NCT02010996|O2|Outcome|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
675466|NCT02010996|O1|Outcome|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
675467|NCT02010996|E4|Reported Event|Axillary Dissection(Shank)|
675468|NCT02010996|E3|Reported Event|Vacuum Assisted Closure(Shank)|
675469|NCT02010996|E2|Reported Event|Axillary Dissection(Thigh)|"Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).~Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids)."
675470|NCT02010996|E1|Reported Event|Vacuum Assisted Closure(Thigh)|"Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.~vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site."
675471|NCT02010684|B3|Baseline|Total|Total of all reporting groups
675472|NCT02010684|B2|Baseline|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants will learn a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675473|NCT02010684|B1|Baseline|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675474|NCT02010684|P2|Participant Flow|Empowerment and CBT Classes|"Participants will attend weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants will learn cognitive behavioral therapy (CBT) techniques to manage their mood. Then participants will learn a diabetes education format grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. Group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis.~Empowerment and CBT Classes: Participants will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers Understanding Depression and Diabetes, Module 2 How Thoughts Affect Your Mood and Diabetes Care, Module 3 How Activities Affect Your Mood and Diabetes Care. The Diabetes Empowerment Modu"
675475|NCT02010684|P1|Participant Flow|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675476|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675477|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675478|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675479|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675480|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675481|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675482|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675483|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675484|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675485|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675500|NCT02010255|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675501|NCT02010255|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
676268|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
675486|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675487|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675488|NCT02010684|O2|Outcome|Empowerment and CBT Classes|"Participants attended weekly 2-hour group Empowerment and CBT classes for 12 weeks led by two trained health educators. Participants learned cognitive behavioral therapy (CBT) techniques to manage their mood. After CBT, participants learned a diabetes education format that is grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood. As part of the intervention activities, group members will be advised to monitor their blood sugar levels, blood pressure, and mood on a daily basis."
675489|NCT02010684|O1|Outcome|Wait-listed Control Group|Participants in the Wait-listed Control Group received augmented access and communication with a primary care provider. The augmentation consisted of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team also attached a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675490|NCT02010684|E2|Reported Event|Empowerment and CBT Classes|"Weekly 2-hour group Empowerment and CBT classes for 12 weeks are led by two trained health educators. Cognitive behavioral therapy (CBT) techniques to manage mood and diabetes education, grounded in empowerment theory that employs group problem solving, individualized goal setting, and personal behavioral change experiments designed to help patients set priorities and to become better self-managers of both diabetes and their mood, is presented. Group members monitor their blood sugar levels, blood pressure, and mood on a daily basis. The intervention arm participants receive a manual with 3 CBT modules (Understanding Depression and Diabetes, How Thoughts Affect Your Mood and Diabetes Care, andHow Activities Affect Your Mood and Diabetes Care. and 1 Diabetes Empowerment module. covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources."
675491|NCT02010684|E1|Reported Event|Wait-listed Control Group|Participants in the Wait-listed Control Group will receive augmented access and communication with a primary care provider. The augmentation would consist of providing the participant with a letter to be shared with their primary care doctor indicating their Hb A1c level and depression score at the time of eligibility screening. The research team will also attach a list of local mental health service providers to the letter. The participants randomized to the wait-listed control group will also be offered access to the intervention after the trial is completed in the event that the randomized controlled trial (RCT) has significant results.
675492|NCT02010632|B1|Baseline|All Study Participants|First intervention: Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7 Wash out period: 14 days Second intervention: Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days. Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7
675493|NCT02010632|P2|Participant Flow|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
675494|NCT02010632|P1|Participant Flow|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
675495|NCT02010632|O2|Outcome|Original Clopidogrel Product|"Plavix® 75mg tablet~Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
675496|NCT02010632|O1|Outcome|Generic Clopidogrel Product|"Apolets® 75 mg tablet~Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
675497|NCT02010632|E2|Reported Event|Original Clopidogrel Product|"Plavix® 75mg tablet (Original Clopidogrel Product first, wash out period for 14 days then Generic Clopidogrel Product) Original clopidogrel product Plavix®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
675498|NCT02010632|E1|Reported Event|Generic Clopidogrel Product|"Apolets® 75 mg tablet (Generic Clopidogrel Product first, wash out period for 14 days then Original Clopidogrel Product) Generic clopidogrel product Apolets®: -Clopidogrel 75 mg once daily for 7 days~-Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
675499|NCT02010255|B15|Baseline|Total|Total of all reporting groups
676001|NCT02008682|P2|Participant Flow|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
675502|NCT02010255|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675503|NCT02010255|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675504|NCT02010255|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675505|NCT02010255|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675506|NCT02010255|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675507|NCT02010255|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675508|NCT02010255|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675509|NCT02010255|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675510|NCT02010255|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675511|NCT02010255|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675512|NCT02010255|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675513|NCT02010255|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675514|NCT02010255|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675515|NCT02010255|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675516|NCT02010255|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675517|NCT02010255|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675518|NCT02010255|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675519|NCT02010255|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675520|NCT02010255|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675521|NCT02010255|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675522|NCT02010255|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675523|NCT02010255|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
675524|NCT02010255|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
676273|NCT02006719|B3|Baseline|Total|Total of all reporting groups
675525|NCT02010255|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675526|NCT02010255|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675527|NCT02010255|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
675528|NCT02010255|O10|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675529|NCT02010255|O9|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675530|NCT02010255|O8|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675531|NCT02010255|O7|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675532|NCT02010255|O6|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675533|NCT02010255|O5|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675534|NCT02010255|O4|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675535|NCT02010255|O3|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675536|NCT02010255|O2|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675537|NCT02010255|O1|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
675538|NCT02010255|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675539|NCT02010255|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675540|NCT02010255|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675541|NCT02010255|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675542|NCT02010255|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675543|NCT02010255|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675544|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675545|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675546|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675570|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
676274|NCT02006719|B2|Baseline|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
675547|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
675548|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675549|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675550|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675551|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675552|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675553|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675554|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675555|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675556|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675557|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675558|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675559|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675560|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675561|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675562|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675563|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675564|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675565|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675566|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675567|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675568|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675569|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
676275|NCT02006719|B1|Baseline|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
675571|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675572|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675573|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675574|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675575|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675576|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675577|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675578|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675579|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675580|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675581|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675582|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675583|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675584|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675585|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675586|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675587|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675588|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675589|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675590|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675591|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675592|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675593|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675618|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675594|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675595|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675596|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675597|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675598|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675599|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675600|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675601|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675602|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675603|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675604|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675605|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675606|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675607|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675608|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675609|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675610|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675611|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675612|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675613|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675614|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675615|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675616|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675617|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675619|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675620|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675621|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675622|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675623|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675624|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675625|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675626|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675627|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675628|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675629|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675630|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675631|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675632|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675633|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675634|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675635|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675636|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675637|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675638|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675639|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675640|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675641|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675642|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675643|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675644|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675645|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675646|NCT02010255|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675647|NCT02010255|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675648|NCT02010255|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675649|NCT02010255|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675650|NCT02010255|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675651|NCT02010255|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675652|NCT02010255|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675653|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675654|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675655|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675656|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675657|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675658|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675659|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675660|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675661|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675662|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675663|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675664|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675665|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675666|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675667|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675668|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675669|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675670|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675671|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675672|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675673|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675674|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675675|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675676|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675677|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675678|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675679|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675680|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675681|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675682|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675683|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675684|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675685|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675686|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675687|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675688|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675689|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675690|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
676276|NCT02006719|P2|Participant Flow|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
675691|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675692|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675693|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675694|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675695|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675696|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675697|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675698|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675699|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675700|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675701|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675702|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675703|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675704|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675705|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675706|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675707|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675708|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675709|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675710|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675711|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675712|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675713|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675859|NCT02009982|P2|Participant Flow|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
675714|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675715|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675716|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675717|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675718|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675719|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675720|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675721|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675722|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675723|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675724|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675725|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675726|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675727|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675728|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675729|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675730|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675731|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675732|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675733|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675734|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675735|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675736|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675737|NCT02010255|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
675908|NCT02009865|P1|Participant Flow|Epanova|2g once daily (QD)
675909|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
675738|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675739|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675740|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675741|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675742|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675743|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675744|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675745|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675746|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675747|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675748|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675749|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675750|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675751|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675752|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675753|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675754|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675755|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675756|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675757|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675758|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675759|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675760|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675761|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675910|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
675911|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
675762|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675763|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675764|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675765|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675766|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675767|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675768|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675769|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675770|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675771|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675772|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675773|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675774|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675775|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675776|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675777|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675778|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675779|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675780|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675781|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675782|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675783|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675784|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675912|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
675913|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
675914|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
675785|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675786|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675787|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675788|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675789|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675790|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675791|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675792|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675793|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675794|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675795|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675796|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675797|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675798|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675799|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675800|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675801|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675802|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675803|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675804|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675805|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675806|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675807|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675808|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675915|NCT02009865|O2|Outcome|Olive Oil|2g once daily (QD)
675809|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675810|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675811|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675812|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675813|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675814|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675815|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675816|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675817|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675818|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675819|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675820|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675821|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675822|NCT02010255|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675823|NCT02010255|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675824|NCT02010255|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675825|NCT02010255|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675826|NCT02010255|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675827|NCT02010255|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675828|NCT02010255|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675829|NCT02010255|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675830|NCT02010255|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675831|NCT02010255|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.
675832|NCT02010255|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675916|NCT02009865|O1|Outcome|Epanova|2g once daily (QD)
675833|NCT02010255|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675834|NCT02010255|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675835|NCT02010255|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675836|NCT02010255|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
675837|NCT02010255|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with FCH
675838|NCT02010255|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675839|NCT02010255|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675840|NCT02010255|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675841|NCT02010255|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).
675842|NCT02010255|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6).
675843|NCT02010255|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6).
675844|NCT02010255|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3.
675845|NCT02010255|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3.~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis."
675846|NCT02010255|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12).
675847|NCT02010255|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12).
675848|NCT02010255|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9).
675849|NCT02010255|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
675850|NCT02010216|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
675851|NCT02010216|P1|Participant Flow|Tocilizumab [RoActemra/Actemra]|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
675852|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
675853|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
675854|NCT02010216|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
675855|NCT02010216|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg by intravenous infusion every 4 weeks for 12 weeks (3 cycles).
675856|NCT02009982|B3|Baseline|Total|Total of all reporting groups
675857|NCT02009982|B2|Baseline|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
675858|NCT02009982|B1|Baseline|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
675860|NCT02009982|P1|Participant Flow|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
675861|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
675862|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
675863|NCT02009982|O2|Outcome|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
675864|NCT02009982|O1|Outcome|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
675865|NCT02009982|E2|Reported Event|Standard Medical Thearpy|Patients in this group did not receive the cardioneuroablation and were managed using standard medical therapy.
675866|NCT02009982|E1|Reported Event|Cardioneuroablation|"Patients in this group received the cardioneuroablation procedure using the Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter~Cardioneuroablation: Catheter Ablation of Vagal Inputs in Left Atrium~Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter: This is the device that was used to perform the Cardioneuroablation procedure"
675867|NCT02009878|B4|Baseline|Total|Total of all reporting groups
675868|NCT02009878|B3|Baseline|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675869|NCT02009878|B2|Baseline|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675870|NCT02009878|B1|Baseline|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675871|NCT02009878|P3|Participant Flow|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675872|NCT02009878|P2|Participant Flow|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675873|NCT02009878|P1|Participant Flow|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675874|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675875|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675876|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675877|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675878|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675879|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675880|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675881|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675882|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675883|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675884|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675885|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675886|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675887|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675888|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675889|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675890|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675891|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675892|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675893|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675894|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675895|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675896|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675897|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675898|NCT02009878|O3|Outcome|Tolvaptan 15 mg|Participants had received a single dose of 15 mg oral tolvaptan.
675899|NCT02009878|O2|Outcome|Tolvaptan 7.5 mg|Participants had received a single dose of 7.5 mg oral tolvaptan.
675900|NCT02009878|O1|Outcome|Tolvaptan 3.75 mg|Participants had received a single dose of 3.75 mg oral tolvaptan.
675901|NCT02009878|E3|Reported Event|Tolvaptan 15 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
675902|NCT02009878|E2|Reported Event|Tolvaptan 7.5 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
675903|NCT02009878|E1|Reported Event|Tolvaptan 3.75 mg|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
675904|NCT02009865|B3|Baseline|Total|Total of all reporting groups
675905|NCT02009865|B2|Baseline|Olive Oil|2g once daily (QD)
675906|NCT02009865|B1|Baseline|Epanova|2g once daily (QD)
675907|NCT02009865|P2|Participant Flow|Olive Oil|2g once daily (QD)
675922|NCT02009722|B2|Baseline|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675923|NCT02009722|B1|Baseline|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675924|NCT02009722|P2|Participant Flow|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675925|NCT02009722|P1|Participant Flow|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675926|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675927|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675928|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675929|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675930|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675931|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675932|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675933|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675934|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675935|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
709115|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
675936|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675937|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675938|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675939|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675940|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675941|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675942|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675943|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675944|NCT02009722|O2|Outcome|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675945|NCT02009722|O1|Outcome|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675946|NCT02009722|E2|Reported Event|Intrathecal Morphine|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal morphine will be 100 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Morphine: Duramorph is administered as part of spinal anesthesia for post-operative pain relief."
675947|NCT02009722|E1|Reported Event|Intrathecal Hydromorphone|"Patients will be randomized to receive a one-time dose of intrathecal hydromorphone or intrathecal morphine as part of their spinal anesthesia. The starting dose of intrathecal hydromorphone will be 40 micrograms. This will be adjusted in subsequent patients based on the previous patient's success or failure according to an up-and-down methodology utilizing a biased coin design.~Hydromorphone: Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control"
675948|NCT02009696|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
675949|NCT02009696|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
675950|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
675951|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
676472|NCT02005029|O1|Outcome|Erythromycin|Five times sit-to-stand for all participants receiving erythromycin
675952|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
675953|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
675954|NCT02009696|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
675955|NCT02009696|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of heart/chest or thoracic spine."
675956|NCT02009163|B1|Baseline|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
675957|NCT02009163|P3|Participant Flow|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26­week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675958|NCT02009163|P2|Participant Flow|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675959|NCT02009163|P1|Participant Flow|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
675960|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675961|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675962|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675963|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675964|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label phase and who had a post-baseline safety assessment.
675965|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675966|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675967|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
675968|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675969|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675970|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
675971|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675972|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675973|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
675974|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
676002|NCT02008682|P1|Participant Flow|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
675975|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675976|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
675977|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675978|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675979|NCT02009163|O1|Outcome|Open-label Safety Population|The Open-label Safety Population included all participants who had taken at least 1 dose of SPD489 in the open-label period and who had a post-baseline safety assessment.
675980|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675981|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675982|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675983|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675984|NCT02009163|O2|Outcome|SPD489 (Randomized­-Withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70 mg was continued throughout the 26-week double-blind randomized-­withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675985|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675986|NCT02009163|O2|Outcome|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675987|NCT02009163|O1|Outcome|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675988|NCT02009163|E3|Reported Event|SPD489 (Randomized-withdrawal Period)|For participants randomized to SPD489, the optimal daily dose of 50 or 70mg was continued throughout the 26-week double-blind randomized-withdrawal phase. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week.
675989|NCT02009163|E2|Reported Event|Placebo (Randomized-withdrawal Period)|During the 26-week double-blind randomized-withdrawal phase, participants randomized to placebo received matching placebo capsules daily. After the 26-week double-blind randomized-withdrawal phase, participants were followed for 1 week .
675990|NCT02009163|E1|Reported Event|SPD489 (Open-label Period)|SPD489 treatment was taken orally once daily at approximately 7:00 AM. All participants began treatment with SPD489 at the lowest dose level (30mg) during the 4-week open-label dose-optimization period. After 1 week of treatment at 30mg, all participants were titrated to the next dose level (50mg). After 1 week of treatment at 50mg, all participants were titrated to the highest dose level (70mg), as tolerated and as clinically indicated. After 1 week of treatment at the highest dose, the participant could have been down-titrated to 50mg; no further dose adjustments were permitted. The optimal daily dose of 50 or 70mg achieved during dose-optimization was maintained throughout the 8-week dose-maintenance period. The total time of the open-label period was 12 weeks.
675991|NCT02008942|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug
675992|NCT02008942|P2|Participant Flow|Enteric Coated (EC) Aspirin First, Then PL2200 Aspirin|"First Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
675993|NCT02008942|P1|Participant Flow|PL2200 Aspirin First, Then Enteric Coated (EC) Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days~(after 2-week washout period)~Second Intervention Period:~EC aspirin: 325 mg aspirin; once per day for 10 days"
675994|NCT02008942|O2|Outcome|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
675995|NCT02008942|O1|Outcome|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
675996|NCT02008942|E2|Reported Event|Enteric-coated Aspirin Caplets|"Enteric-coated aspirin caplets~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 10 days"
675997|NCT02008942|E1|Reported Event|PL2200 Aspirin Capsules|"PL2200 Aspirin Capsules~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 10 days"
675998|NCT02008682|B3|Baseline|Total|Total of all reporting groups
675999|NCT02008682|B2|Baseline|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
676000|NCT02008682|B1|Baseline|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676004|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676005|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
676006|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676007|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
676008|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676009|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
676010|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676011|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
676012|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676013|NCT02008682|O2|Outcome|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
676014|NCT02008682|O1|Outcome|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676015|NCT02008682|E2|Reported Event|Sitagliptin|orally, once-daily dose of sitagliptin 100 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily).
676016|NCT02008682|E1|Reported Event|Liraglutide|subcutaneously, once-daily dose of liraglutide 1.8 mg with metformin at pre-trial stable dose (at least 1500 mg or maximum tolerated dose at least 1000 mg daily). Liraglutide dose was escalated from 0.6 mg/day to 1.8 mg/day during 3-4 weeks.
676017|NCT02008617|B3|Baseline|Total|Total of all reporting groups
676018|NCT02008617|B2|Baseline|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
676019|NCT02008617|B1|Baseline|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
676020|NCT02008617|P2|Participant Flow|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
676021|NCT02008617|P1|Participant Flow|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
676022|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
676023|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
676024|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
676025|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
676026|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
676027|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
676028|NCT02008617|O2|Outcome|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
676029|NCT02008617|O1|Outcome|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
676030|NCT02008617|E2|Reported Event|Preservative Free Normal Saline|"Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline~Preservative free normal saline: Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline"
676031|NCT02008617|E1|Reported Event|Study Drug|"Ultrasound guided posterior genicular nerve infiltration with 30mL of Bupivicaine 0.20% with epinephrine 1:300,000~Bupivacaine: 30mL of Bupivicaine 0.20% with epinephrine 1:300,000"
676473|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
676032|NCT02007863|B1|Baseline|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
676033|NCT02007863|P1|Participant Flow|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
676034|NCT02007863|O1|Outcome|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
676035|NCT02007863|E1|Reported Event|Umbilical Cord Blood + Chemotherapy|"Umbilical Cord Blood Transfusion: Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0~Fludarabine: Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days –13 through –9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.~Busulfan: Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.~Melphalan: Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days –4 through –2 for a total of 3 doses."
676036|NCT02007577|B3|Baseline|Total|Total of all reporting groups
676037|NCT02007577|B2|Baseline|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
676038|NCT02007577|B1|Baseline|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
676039|NCT02007577|P2|Participant Flow|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
676040|NCT02007577|P1|Participant Flow|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
676041|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
676042|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
676043|NCT02007577|O2|Outcome|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
676044|NCT02007577|O1|Outcome|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
676045|NCT02007577|E2|Reported Event|Placebo|"Participants will take 3 placebo tablets with breakfast and 4 placebo tablets with dinner~Placebo: Participants will take 3 tablets with breakfast and 4 tablets with dinner"
676046|NCT02007577|E1|Reported Event|Salsalate 3500mg in 2 Divided Doses a Day|"Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner~salsalate: Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner"
676047|NCT02007434|B9|Baseline|Total|Total of all reporting groups
676048|NCT02007434|B8|Baseline|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676049|NCT02007434|B7|Baseline|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676050|NCT02007434|B6|Baseline|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676051|NCT02007434|B5|Baseline|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676052|NCT02007434|B4|Baseline|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676474|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
676053|NCT02007434|B3|Baseline|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676054|NCT02007434|B2|Baseline|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676055|NCT02007434|B1|Baseline|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676056|NCT02007434|P8|Participant Flow|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676057|NCT02007434|P7|Participant Flow|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676058|NCT02007434|P6|Participant Flow|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676059|NCT02007434|P5|Participant Flow|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676060|NCT02007434|P4|Participant Flow|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676061|NCT02007434|P3|Participant Flow|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676062|NCT02007434|P2|Participant Flow|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676063|NCT02007434|P1|Participant Flow|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL (based on Baseline Clinician-Reported Submental Fat Rating Scale [CR-SMFRS] grade 2 or 3, respectively) on Day 0 and a cold compress applied to the treatment area.
676064|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676065|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676066|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676067|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676068|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676069|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676070|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676071|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676072|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676073|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676074|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676075|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676076|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676077|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676078|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676080|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676081|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676082|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676083|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676084|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676085|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676086|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676087|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676088|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676089|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676090|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676091|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676092|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676093|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676094|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676095|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676096|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676097|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676098|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676099|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676100|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676101|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676102|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676103|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676104|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676475|NCT02005029|O2|Outcome|Placebo|Mean time for right hand after placebo
709116|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
676210|NCT02006836|B1|Baseline|Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
676105|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676106|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676107|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676108|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676109|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676110|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676111|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676112|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676113|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676114|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676115|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676116|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676117|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676118|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676119|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676120|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676121|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676122|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676123|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676124|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676125|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676126|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676127|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676128|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676129|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676130|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
709117|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
676131|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676132|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676133|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676134|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676135|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676136|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676137|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 to 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676138|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676139|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676140|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676141|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676142|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676143|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676144|NCT02007434|O8|Outcome|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676145|NCT02007434|O7|Outcome|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676146|NCT02007434|O6|Outcome|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676147|NCT02007434|O5|Outcome|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676148|NCT02007434|O4|Outcome|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
676149|NCT02007434|O3|Outcome|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676150|NCT02007434|O2|Outcome|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676151|NCT02007434|O1|Outcome|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676152|NCT02007434|E8|Reported Event|Paradigm 4 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676153|NCT02007434|E7|Reported Event|Paradigm 4 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, a compression chin strap, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676154|NCT02007434|E6|Reported Event|Paradigm 3 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents, topical and injectable anesthetics and a cold compress applied to the treatment area.
676155|NCT02007434|E5|Reported Event|Paradigm 3 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, oral antihistamine and anti-inflammatory agents (loratadine and ibuprofen), topical and injectable anesthetics and a cold compress applied to the treatment area.
676156|NCT02007434|E4|Reported Event|Paradigm 2 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics and a cold compress applied to the treatment area.
709118|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
676157|NCT02007434|E3|Reported Event|Paradigm 2 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0, topical and injectable anesthetics (lidocaine/epinephrine) and a cold compress applied to the treatment area.
676158|NCT02007434|E2|Reported Event|Paradigm 1 / Placebo|Participants received placebo administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676159|NCT02007434|E1|Reported Event|Paradigm 1 / Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, either 6 or 8 mL on Day 0 and a cold compress applied to the treatment area.
676160|NCT02007369|B4|Baseline|Total|Total of all reporting groups
676161|NCT02007369|B3|Baseline|Control|No intervention
676162|NCT02007369|B2|Baseline|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
676163|NCT02007369|B1|Baseline|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
676164|NCT02007369|P3|Participant Flow|Control|No intervention
676165|NCT02007369|P2|Participant Flow|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
676166|NCT02007369|P1|Participant Flow|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
676167|NCT02007369|O3|Outcome|Control|No intervention
676168|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
676169|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
676170|NCT02007369|O3|Outcome|Control|No intervention
676171|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
676172|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
676173|NCT02007369|O3|Outcome|Control|No intervention
676174|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
676175|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
676176|NCT02007369|O3|Outcome|Control|No intervention
676177|NCT02007369|O2|Outcome|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
676178|NCT02007369|O1|Outcome|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
676179|NCT02007369|E3|Reported Event|Control|No intervention
676180|NCT02007369|E2|Reported Event|Facebook|"Peer to peer support and delivery of information through facebook for 8 weeks.~Peer to peer support and delivery of information through Facebook: Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook. They will be strongly suggested to follow the regulations and set up instructions for the participation to protect their privacy."
676181|NCT02007369|E1|Reported Event|WhatsApp|"Peer to peer support and delivery of information through WhatsApp for 8 weeks~Peer to peer support and delivery of information through WhatsApp groups: Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp. In order to sustain the abstinence among the participants in the social groups, the intervention content is about (1) Encourage to maintain abstinence; (2) Importance of remaining abstinence; (3) Prevent smoking triggers; (4) Withdrawal symptoms & lapse; (5) Stress and mood management; (6) weight control. We propose the moderator to spend about 1 to 2 hours a day in total for the social group conversation in a flexible time schedule, and the duration of the intervention will be 8 weeks."
676182|NCT02007252|B3|Baseline|Total|Total of all reporting groups
676183|NCT02007252|B2|Baseline|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
676184|NCT02007252|B1|Baseline|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
676185|NCT02007252|P2|Participant Flow|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
676186|NCT02007252|P1|Participant Flow|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
676187|NCT02007252|O2|Outcome|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
676188|NCT02007252|O1|Outcome|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
676189|NCT02007252|E2|Reported Event|Placebo|Participants received matching placebo to ACZ885 s.c. once per month for 12 months.
676190|NCT02007252|E1|Reported Event|ACZ885|Participants received ACZ885 150 mg subcutaneously (s.c.) once per month for 12 months.
676191|NCT02007200|B1|Baseline|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
676192|NCT02007200|P1|Participant Flow|Treatment (Soy Isoflavones)|"Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.~55 patients were enrolled. 3 of these patients did not receive treatment."
676193|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
676194|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
676195|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
676196|NCT02007200|O1|Outcome|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
676197|NCT02007200|E1|Reported Event|Treatment (Soy Isoflavones)|Patients receive soy isoflavones PO for approximately 14 days before undergoing surgery.
676198|NCT02007070|B1|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676199|NCT02007070|P1|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676200|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676201|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676202|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676203|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676204|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676205|NCT02007070|O1|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676206|NCT02007070|E1|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg intravenously over 30 minutes on Day 1 of each 21-day cycle for up to 2 years.
676207|NCT02006836|B4|Baseline|Total|Total of all reporting groups
676208|NCT02006836|B3|Baseline|Diabetic 2|For self-control period. The scheme and dose of Continuous Subcutaneous Insulin Infusion (CSII) for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.
676209|NCT02006836|B2|Baseline|Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
676476|NCT02005029|O1|Outcome|Erythromycin|Mean time for right hand after erythromycin
676211|NCT02006836|P3|Participant Flow|Self-Control: Diabetic 2|"For self-control period. Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days.~On the 4th to 6th day, patients with a constant dose of insulin did not consume Majia pomelos after meals, and this intervention was defined as blank.~On the 7th to 9th day, patients with the same dose of insulin consumed 100g Majia pomelos after meals (breakfast, lunch and dinner)."
676212|NCT02006836|P2|Participant Flow|Case-Control: Healthy|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
676213|NCT02006836|P1|Participant Flow|Case-Control: Diabetic|For case-control period and for GI measurement. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
676214|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
676215|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
676216|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
676217|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
676218|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
676219|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
676220|NCT02006836|O2|Outcome|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
676221|NCT02006836|O1|Outcome|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
676222|NCT02006836|O2|Outcome|Healthy|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
676223|NCT02006836|O1|Outcome|Diabetic|For case-control period. 50 g of glucose dissolved in 200 ml water followed sequentially by 50g carbohydrate equivalents of 922g Majia pomelos.
676224|NCT02006836|E4|Reported Event|Diabetic 2 - With Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 7th to 9th day with a constant dose of insulin and consumed 100g Majia pomelos after meals (breakfast, lunch and dinner).
676269|NCT02006732|E4|Reported Event|Tiotropium 5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676270|NCT02006732|E3|Reported Event|Tiotropium 2.5 μg +Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
709119|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
676277|NCT02006719|P1|Participant Flow|AA4500|Up to 3 injections of 0.58 mg/1 mL collagenase clostridium histolyticum (AA4500), minimum of 21 days apart and home shoulder exercise
676225|NCT02006836|E3|Reported Event|Diabetic 2 - Without Pomelo|Patients of Diabetic 2 group were on CSII treatment with insulin subcutaneous pump.The scheme and dose of CSII for each patients were adjusted on the first 3 test days to optimize glucose control, followed by 3-day CSII treatment without change of insulin dose. On the 7th test day, patients consumed 100g Majia pomelos after meals (breakfast, lunch and dinner) for 3 test days. This arm refers to the group on the 4th to 6th day with a constant dose of insulin and did not consumed Majia pomelos after meals, and this intervention was defined as blank.
676226|NCT02006836|E2|Reported Event|Healthy|On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of volunteers enrolled for the case control period.
676227|NCT02006836|E1|Reported Event|Diabetic|Diabetic patients use oral antidiabetic drugs(metformin or pioglitazone or both) or only life style modification. On the first test day we utilized 50 g of glucose dissolved in 200 ml water. The second day was washout day. On the third day we used 922 g of Majia pomelos which contained 50 g carbohydrate.This group of diabetic patients enrolled for the case control period.
676228|NCT02006732|B5|Baseline|Total|Total of all reporting groups
676229|NCT02006732|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676230|NCT02006732|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676231|NCT02006732|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676232|NCT02006732|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676233|NCT02006732|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676234|NCT02006732|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676235|NCT02006732|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676236|NCT02006732|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676237|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676238|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676239|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676240|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676241|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676242|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676243|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676244|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676245|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676246|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676247|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676248|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676249|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676250|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676251|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676252|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676253|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676254|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676255|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676256|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676257|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676258|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676259|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676260|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676261|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676262|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676263|NCT02006732|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
676264|NCT02006732|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
676265|NCT02006732|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676266|NCT02006732|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
676278|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676279|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676280|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676281|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676282|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676283|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676284|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676285|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676286|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676287|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676288|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676289|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676290|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676291|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676292|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676293|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676294|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676295|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676296|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676297|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676298|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676299|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676300|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676301|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676302|NCT02006719|O2|Outcome|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676303|NCT02006719|O1|Outcome|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676304|NCT02006719|E2|Reported Event|Placebo|Up to three 1-mL injections of placebo, minimum of 21 days apart and home shoulder exercise
676305|NCT02006719|E1|Reported Event|AA4500|Up to 3 injections of 0.58 mg/1 mL AA4500, minimum of 21 days apart and home shoulder exercise
676306|NCT02006706|B1|Baseline|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
676307|NCT02006706|P1|Participant Flow|Rituximab/Methylprednisolone/Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg), intravaneously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
676308|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
676309|NCT02006706|O1|Outcome|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
676310|NCT02006706|E1|Reported Event|Rituximab/Methylprednisolone/MTX|Participants received rituximab 1000 mg, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15. Participants also received MTX, 10 to 25 mg per week (at a stable dose at the discretion of investigator and in accordance with the local label), orally (or parenterally, as prescribed) and folate 5 mg per week, orally, for up to 24 weeks.
676311|NCT02006667|B1|Baseline|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676312|NCT02006667|P1|Participant Flow|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg per kilogram (mg/kg), IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676403|NCT02005484|E1|Reported Event|Trastuzumab Monotherapy|Participants received trastuzumab via IV infusion once weekly at an initial dose of 4 mg/kg at Visit 1, and 2 mg/kg at each subsequent visit for a maximum of 33 visits.
709120|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
676478|NCT02005029|O1|Outcome|Erythromycin|Area under the curve 0-4 hours for plasma levodopa after erythromycin
676313|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676314|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676315|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676316|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676317|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676318|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676319|NCT02006667|O1|Outcome|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676320|NCT02006667|E1|Reported Event|Trastuzumab/Gemcitabine/Cisplatin|Participants received gemcitabine 1200 mg/m^2, IV, on Days 1, 8, and 15 (for a maximum of six 4-week cycles); cisplatin 70 mg/m^2, IV, on Day 2 (for a maximum of six 4-week cycles); and trastuzumab 4 mg/kg, IV, on Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg, IV, until disease progression.
676321|NCT02006407|B1|Baseline|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
676322|NCT02006407|P1|Participant Flow|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
676323|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
676324|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
676325|NCT02006407|O1|Outcome|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
676352|NCT02005562|P2|Participant Flow|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676326|NCT02006407|E1|Reported Event|Primary Brain Tumor|"Patients receiving standard cranial radiotherapy will undergo (1) Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI) and (2) Neuro-cognitive testing (CogState-a computerized software testing system that offers various cognitive assessments based on traditional expansive neurocognitive tests) at four timepoints (Baseline, 3 weeks, 6 weeks and 6 months).~Cranial Radiotherapy: Standard cranial radiotherapy administered dependent upon patient and brain tumor type.~MRI with Diffusion Tensor Imaging (DTI): Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)~Neuro-cognitive Testing (CogState): CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests."
676327|NCT02006342|B3|Baseline|Total|Total of all reporting groups
676328|NCT02006342|B2|Baseline|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676329|NCT02006342|B1|Baseline|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676330|NCT02006342|P2|Participant Flow|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676331|NCT02006342|P1|Participant Flow|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676332|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676333|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676334|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676335|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676336|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676337|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676338|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676339|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676340|NCT02006342|O2|Outcome|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676341|NCT02006342|O1|Outcome|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676342|NCT02006342|E2|Reported Event|Control - Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring.~Regular Insulin"
676343|NCT02006342|E1|Reported Event|Insulin Glargine Plus Regular Insulin|"Patient's with Diabetic Ketoacidosis receiving standard of care treatment with regular insulin drip, IV fluids and close monitoring, with the addition of subcutaneous Insulin Glargine within 2 hours of diagnosis.~Insulin Glargine~Regular Insulin"
676344|NCT02005692|B1|Baseline|DynaSense Sensor|All subjects who successfully completed the study.
676345|NCT02005692|P1|Participant Flow|DynaSense Sensor|"All patients enrolled in the study were prescribed a Q2 hour (every 2 hour) turning protocol, as per the standard guidelines of the study site. In the context of the study, caregivers were not asked to turn patients any more or less frequently than what the study site's standard turning protocol required.~The rate of compliance with prescribed turning protocols was measured using the DynaSense System."
676346|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects who successfully completed the study.
676347|NCT02005692|O1|Outcome|DynaSense Sensor|All subjects enrolled in the study.
676348|NCT02005692|E1|Reported Event|DynaSense Sensor|All subjects enrolled in the study.
676349|NCT02005562|B3|Baseline|Total|Total of all reporting groups
676350|NCT02005562|B2|Baseline|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676351|NCT02005562|B1|Baseline|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676470|NCT02005029|O1|Outcome|Erythromycin|Mean CGS for all participants receiving erythromycin
676353|NCT02005562|P1|Participant Flow|Mycophenolate Mofetil, Adapted Dose|Participants received mycophenolate mofetil (MMF), 3 grams (g), tablets or capsules, orally (PO), every 12 hours (q12h) adapted to mycophenolic acid (MPA) by area under the curve (AUC) on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a 2 hour postdose (C2) level equal to (=) 1000 to 1500 nanograms per milliliter (ng/mL) from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 milligrams (mg), intravenously (IV), on Day -1 or Day 0, and 0.5 mg per kilogram (mg/kg), PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-interleukin (IL)-2R, per the investigator's discretion.
676354|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676355|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676356|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676357|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676358|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676359|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676360|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676361|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676362|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676363|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676364|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676471|NCT02005029|O2|Outcome|Placebo|Five times sit-to-stand for all participants receiving placebo
676365|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676366|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676367|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676368|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676369|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676370|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676371|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676372|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676373|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676374|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676375|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676376|NCT02005562|O2|Outcome|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676402|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
709121|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
676377|NCT02005562|O1|Outcome|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676378|NCT02005562|E2|Reported Event|Mycophenolate Mofetil, Fixed Dose|Participants received MMF 2 g, tablets or capsules, PO, q12h on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to C2 = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52 and methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676379|NCT02005562|E1|Reported Event|Mycophenolate Mofetil, Adapted Dose|Participants received MMF, 3 g, tablets or capsules, PO, q12h adapted to MPA by AUC on Day -1 or Day 0 through Week 52. Participants also received cyclosporine adapted to a C2 level = 1000 to 1500 ng/mL from Day 0 to Week 4, C2 = 800 to 1200 ng/mL from Weeks 4 to 12, and C2 = 500 to 800 ng/mL from Weeks 12 to 52. Participants also received methylprednisolone 500 mg, IV, on Day -1 or Day 0, and 0.5 mg/kg, PO, daily (maximum daily dose of 60 mg) from Days 1 through 7 (with steroid withdrawal on Day 7). Participants also received anti-IL-2R, per the investigator's discretion.
676380|NCT02005549|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
676381|NCT02005549|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 milligrams/kilogram (mg/kg) intravenously (IV), followed by docetaxel 75 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 950 mg/m^2 orally (PO) twice daily (BID) within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
676382|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
676383|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
676384|NCT02005549|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
676385|NCT02005549|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m^2 IV on Day 1 and capecitabine 950 mg/m^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.
676386|NCT02005536|B1|Baseline|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676387|NCT02005536|P1|Participant Flow|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676388|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676389|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676390|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676391|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676392|NCT02005536|O1|Outcome|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676393|NCT02005536|E1|Reported Event|IMOVAX POLIO® Vaccine Group|Participants received a single booster dose of IMOVAX POLIO® vaccine on Day 0.
676394|NCT02005484|B1|Baseline|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676395|NCT02005484|P1|Participant Flow|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676396|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676397|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676398|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676399|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676400|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676401|NCT02005484|O1|Outcome|Trastuzumab Monotherapy|Participants received trastuzumab at an initial dose of 4 mg/kg IV on Day 1, followed by maintenance doses of 2 mg/kg, IV, once weekly starting on Day 8 up to a maximum of 33 weeks.
676404|NCT02005393|B1|Baseline|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System immediately followed by Image Acquisition with NBI~FICE Image Acquisition System: Images Captured with FICE Device"
676405|NCT02005393|P1|Participant Flow|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition immediately followed by NBI Image Acquisition~FICE Image Acquisition System: Images Captured with FICE Device"
676406|NCT02005393|O1|Outcome|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by NBI Image Acquisition; always in that order.~FICE Image Acquisition System: Images Captured with FICE Device"
676407|NCT02005393|E1|Reported Event|FICE Image Acquisition Followed by NBI Image Acquisition|"Images Captured with FICE Image Acquisition System, immediately followed by Image Acquisition with NBI~FICE Image Acquisition System: Images Captured with FICE Device~No AE's"
676408|NCT02005211|B8|Baseline|Total|Total of all reporting groups
676409|NCT02005211|B7|Baseline|Placebo Part 2|Placebo Part 2 - MAD
676410|NCT02005211|B6|Baseline|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
676411|NCT02005211|B5|Baseline|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
676412|NCT02005211|B4|Baseline|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
676413|NCT02005211|B3|Baseline|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
676414|NCT02005211|B2|Baseline|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
676415|NCT02005211|B1|Baseline|Placebo Part 1|Placebo Part 1 - SAD
676416|NCT02005211|P7|Participant Flow|Placebo Part 2|Placebo Part 2 - MAD
676417|NCT02005211|P6|Participant Flow|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
676418|NCT02005211|P5|Participant Flow|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
676419|NCT02005211|P4|Participant Flow|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
676420|NCT02005211|P3|Participant Flow|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
676421|NCT02005211|P2|Participant Flow|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
676422|NCT02005211|P1|Participant Flow|Placebo Part 1|Placebo Part 1 - SAD
676423|NCT02005211|O7|Outcome|Placebo Part2|Placebo Part 2 - MAD
676424|NCT02005211|O6|Outcome|Placebo Part 1|Placebo Part 1 - SAD
676425|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
676426|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
676427|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
676428|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
676429|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
676430|NCT02005211|O7|Outcome|Placebo Part 2|Placebo Part 2 - MAD
676431|NCT02005211|O6|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
676432|NCT02005211|O5|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
676433|NCT02005211|O4|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
676434|NCT02005211|O3|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
676435|NCT02005211|O2|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
676436|NCT02005211|O1|Outcome|Placebo Part 1|Placebo Part 1 - SAD
676437|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
676438|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
676439|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
676440|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
676441|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
676442|NCT02005211|O5|Outcome|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
676443|NCT02005211|O4|Outcome|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
676444|NCT02005211|O3|Outcome|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
676445|NCT02005211|O2|Outcome|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
676446|NCT02005211|O1|Outcome|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
676447|NCT02005211|E7|Reported Event|Placebo Part 2|Placebo Part 2 - MAD
676448|NCT02005211|E6|Reported Event|AZD3293 50 mg Part 2|AZD3293 50 mg Part 2 - MAD
676449|NCT02005211|E5|Reported Event|AZD3293 15 mg Part 2|AZD3293 15 mg Part 2 -MAD
676450|NCT02005211|E4|Reported Event|AZD3293 150 mg Part 1|AZD3293 150 mg Part 1 - SAD
676451|NCT02005211|E3|Reported Event|AZD3293 50 mg Part 1|AZD3293 50 mg Part 1 - SAD
676452|NCT02005211|E2|Reported Event|AZD3293 15 mg Part 1|AZD3293 15 mg Part 1 - SAD
676453|NCT02005211|E1|Reported Event|Placebo Part 1|Placebo Part 1 - SAD
676454|NCT02005029|B3|Baseline|Total|Total of all reporting groups
676455|NCT02005029|B2|Baseline|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
676456|NCT02005029|B1|Baseline|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
676457|NCT02005029|P2|Participant Flow|Erythromycin Then Placebo|One time IV dose of 100 mg Erythromycin followed by 1 time IV dose of placebo (after 2 week washout)
676458|NCT02005029|P1|Participant Flow|Placebo First Then Erythromycin|One time IV dose of placebo followed by 1 time IV dose of Erythromycin (after 2 week washout)
676459|NCT02005029|O2|Outcome|Placebo|Cmax of plasma levodopa after placebo
676460|NCT02005029|O1|Outcome|Erythromycin|Cmax of plasma levodopa after erythromycin
676461|NCT02005029|O2|Outcome|Placebo|
676462|NCT02005029|O1|Outcome|Erythromycin|
676463|NCT02005029|O2|Outcome|Placebo|AIMS after receiving placebo
676464|NCT02005029|O1|Outcome|Erythromycin|AIMS after receiving erythromycin
676465|NCT02005029|O2|Outcome|Placebo|TUAG (fast speed) after placebo
676466|NCT02005029|O1|Outcome|Erythromycin|TUAG (fast speed) after erythromycin
676467|NCT02005029|O2|Outcome|Placebo|TUAG (comfortable speed) after placebo
676468|NCT02005029|O1|Outcome|Erythromycin|TUAG (comfortable speed) after erythromycin
676469|NCT02005029|O2|Outcome|Placebo|Mean CGS for all participants receiving placebo
709122|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
676480|NCT02005029|O1|Outcome|Erythromycin|Mean gastric emptying time for participants receiving erythromycin
676481|NCT02005029|E2|Reported Event|Placebo|Participants who received a one time dose of placebo
676482|NCT02005029|E1|Reported Event|Erythromycin|Participants who received a one time dose of IV erythromycin
676483|NCT02004990|B1|Baseline|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
676484|NCT02004990|P1|Participant Flow|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
676485|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
676486|NCT02004990|O1|Outcome|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
676487|NCT02004990|E1|Reported Event|Single Cleansing Procedure of 10% Povidone Iodine Cleansing|"10% povidone iodine cleansing~Single cleansing procedure of 10% Povidone Iodine: Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application"
676488|NCT02004886|B5|Baseline|Total|Total of all reporting groups
676489|NCT02004886|B4|Baseline|Placebo|Placebo
676490|NCT02004886|B3|Baseline|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676491|NCT02004886|B2|Baseline|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676492|NCT02004886|B1|Baseline|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676493|NCT02004886|P4|Participant Flow|Placebo|Placebo
676494|NCT02004886|P3|Participant Flow|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676495|NCT02004886|P2|Participant Flow|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676496|NCT02004886|P1|Participant Flow|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676497|NCT02004886|O4|Outcome|Placebo|Placebo
676498|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676499|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676500|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676501|NCT02004886|O4|Outcome|Placebo|Placebo
676502|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676503|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676504|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676505|NCT02004886|O4|Outcome|Placebo|Placebo
676506|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676507|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676508|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676509|NCT02004886|O4|Outcome|Placebo|Placebo
676510|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676511|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676512|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676513|NCT02004886|O4|Outcome|Placebo|Placebo
676514|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676515|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676516|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676517|NCT02004886|O4|Outcome|Placebo|Placebo
676518|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676519|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676520|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676521|NCT02004886|O4|Outcome|Placebo|Placebo
676522|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676523|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676524|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676525|NCT02004886|O4|Outcome|Placebo|Placebo
676526|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676527|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676528|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676529|NCT02004886|O4|Outcome|Placebo|Placebo
676530|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676531|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676532|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676533|NCT02004886|O4|Outcome|Placebo|Placebo
676534|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676535|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676536|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676537|NCT02004886|O4|Outcome|Placebo|Placebo
676538|NCT02004886|O3|Outcome|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676539|NCT02004886|O2|Outcome|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676540|NCT02004886|O1|Outcome|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676541|NCT02004886|E4|Reported Event|Placebo|Placebo
676542|NCT02004886|E3|Reported Event|Metformin (2000 mg)|Metformin, oral, 1000 mg, twice daily
676543|NCT02004886|E2|Reported Event|MK-0893 (120 mg)|MK-0893, 120 mg, once daily
676544|NCT02004886|E1|Reported Event|MK-0893 (40 mg)|MK-0893 40-mg, once daily
676545|NCT02004873|B1|Baseline|Micra Study Enrollments|All subjects enrolled in the Micra study
709123|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
676546|NCT02004873|P1|Participant Flow|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
677634|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
676547|NCT02004873|O1|Outcome|Micra Subjects With Usable M-PREP Data|Subjects implanted with Micra who had usable M-PREP test(s) at 3-month and/or 6-month visits.
676548|NCT02004873|O1|Outcome|Micra Subjects With 6-month PCT Data|Subjects implanted with Micra who had paired ventricular capture management PCT and auto decrement PCT data available at the 6-month visit.
676549|NCT02004873|O1|Outcome|Micra Subjects With Implant and 6-month PCT Data|Subjects implanted with Micra who had paired implant and 6-month auto decrement PCT values (0.24 ms), or who had a system modification or alternative device implant prior to 6 months due to elevated threshold.
676550|NCT02004873|O1|Outcome|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
676551|NCT02004873|E1|Reported Event|Micra Pacemaker Implant|All subjects who attempted Micra implant procedure
676552|NCT02004847|B3|Baseline|Total|Total of all reporting groups
676553|NCT02004847|B2|Baseline|Low Intensity (LI) vs Control|"PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
676554|NCT02004847|B1|Baseline|High Intensity (HI) vs Control|"PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.~PSO-CT02: The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light."
676555|NCT02004847|P2|Participant Flow|Low Intensity (LI) vs. Control|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676556|NCT02004847|P1|Participant Flow|High Intensity (HI) vs. Control|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676557|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676558|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676559|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676560|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676561|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676562|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676563|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676564|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676565|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
676566|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
676567|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
676568|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
676569|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676570|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676571|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676572|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676573|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676574|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676575|NCT02004847|O2|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676576|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676577|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient
676578|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676579|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
676580|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676581|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
676582|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676583|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
676584|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676585|NCT02004847|O4|Outcome|Control (LI)|Contralateral untreated control plaque on the same patient.
676586|NCT02004847|O3|Outcome|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity
676587|NCT02004847|O2|Outcome|Control (HI)|Contralateral untreated control plaque on the same patient
676588|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
676596|NCT02004847|O1|Outcome|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity
676597|NCT02004847|E2|Reported Event|Low Intensity (LI)|PSO-CT02 device: Light wavelength 453nm, low intensity versus contralateral untreated control plaque on the same patient.
676598|NCT02004847|E1|Reported Event|High Intensity (HI)|PSO-CT02 device: Light wavelength 453nm, high intensity versus contralateral untreated control plaque on the same patient.
676599|NCT02004236|B4|Baseline|Total|Total of all reporting groups
676600|NCT02004236|B3|Baseline|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676601|NCT02004236|B2|Baseline|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676602|NCT02004236|B1|Baseline|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676603|NCT02004236|P3|Participant Flow|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676604|NCT02004236|P2|Participant Flow|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676605|NCT02004236|P1|Participant Flow|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676606|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676607|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676608|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676609|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676610|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676611|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676612|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676613|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676614|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676615|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676616|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676617|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676618|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676619|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676620|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676621|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676622|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676623|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676624|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676625|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676626|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676627|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676628|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676629|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676630|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676696|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
677466|NCT01996709|E2|Reported Event|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
676631|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676632|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676633|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676634|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676635|NCT02004236|O1|Outcome|tRNS Over Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676636|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676637|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676638|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676639|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676640|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676641|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676642|NCT02004236|O3|Outcome|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676643|NCT02004236|O2|Outcome|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676644|NCT02004236|O1|Outcome|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676645|NCT02004236|E3|Reported Event|tRNS With Sham|"This group receive 35 sessions with sham~tRNS with sham: the subjects receive 35 session with sham"
676646|NCT02004236|E2|Reported Event|tRNS Over Fusiform Temporal Cortex|"This group receive 35 sessions of tRNS over fusiform temporal cortex~tRNS over fusiform temporal cortex: This group receive 35 sessions of tRNS over fusiform temporal cortex"
676647|NCT02004236|E1|Reported Event|tRNS Fronto-temporal Cortex|"This group receive 35 sessions of tRNS over fronto-temporal cortex~tRNS Fronto-temporal cortex: This group receive 35 sessions of tRNS over fronto-temporal cortex"
676648|NCT02004132|B1|Baseline|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
676649|NCT02004132|P1|Participant Flow|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
676650|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
676651|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
676652|NCT02004132|O1|Outcome|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
676653|NCT02004132|E1|Reported Event|Axiron 120 mg|Single 120 milligrams (mg) total dose given to participants as two 1.5 milliliters (mL) topical applications to each underarm (60 mg per underarm) in the morning on Day 1 using a pump.
676654|NCT02004093|B3|Baseline|Total|Total of all reporting groups
676655|NCT02004093|B2|Baseline|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676656|NCT02004093|B1|Baseline|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676657|NCT02004093|P2|Participant Flow|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676658|NCT02004093|P1|Participant Flow|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 milligrams (mg) intravenously (IV) on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/square meters (m^2) IV on Day 1 and carboplatin target area under the curve (AUC) 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676659|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
710579|NCT01787188|E3|Reported Event|Placebo|Placebo: Capsule
676660|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676661|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676662|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676663|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676664|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676665|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676666|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen17 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676667|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676668|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676669|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676670|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676671|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676672|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676673|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676674|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676675|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676676|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER: 1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676677|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676678|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off
676679|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676680|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676681|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676682|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676683|NCT02004093|O2|Outcome|Chemotherapy|Participants received chemotherapy with EITHER: 1) paclitaxel 175 mg/m^2 on Day 1 and carboplatin AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off.
676684|NCT02004093|O1|Outcome|Chemotherapy + Pertuzumab|"Participants received pertuzumab for a total of seventeen 3-week cycles and chemotherapy for a total of six 3-week cycles.~Pertuzumab: Participants received pertuzumab 840 mg IV on Day 1 of cycle 1 and 420 mg IV on Day 1 of cycles 2 to 17; Chemotherapy consisted of EITHER:1) paclitaxel 175 mg/m^2 IV on Day 1 and carboplatin target AUC 5, IV, on Day 1 followed by 2 weeks off OR 2) gemcitabine 1000 mg/m^2, IV, on Days 1 and 8 (with carboplatin target AUC of 4, IV on Day 1 only) followed by 1 week off."
676685|NCT02004093|E2|Reported Event|Chemotherapy|Participants received chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/ m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
676686|NCT02004093|E1|Reported Event|Chemotherapy + Pertuzumab|Participants received loading dose of 840mg IV Pertuzumab, followed by 420 mg IV every 3 weeks (for a total of 17 cycles), along with chemotherapy with either Paclitaxel or Gemcitabine. Paclitaxel dosage was 175 mg/m2 IV every 3 weeks for 6 cycles, followed by Carboplatin AUC of 5; Gemcitabine dosage was 1000 mg/m2 IV on day 1 and 8 of each cycle for 6 cycles followed by Carboplatin AUC of 4, IV every 3 weeks for 6 cycles.
676687|NCT02003963|B3|Baseline|Total|Total of all reporting groups
676688|NCT02003963|B2|Baseline|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676689|NCT02003963|B1|Baseline|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
676690|NCT02003963|P2|Participant Flow|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676691|NCT02003963|P1|Participant Flow|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.~Klub Kinect: Dance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs."
676692|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676693|NCT02003963|O1|Outcome|Exergame Intervention|Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently.
676694|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676695|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
677622|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
676697|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
676698|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676699|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
676700|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676701|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
676702|NCT02003963|O2|Outcome|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676703|NCT02003963|O1|Outcome|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
676704|NCT02003963|E2|Reported Event|Control (Self-Directed Care)|The control condition will receive no contact or intervention other than telephone reminders of their final clinic visit.
676705|NCT02003963|E1|Reported Event|Exergame Intervention|"Participants randomly assigned to the exergame condition will participate in the intervention condition of Klub Kinect. Klub Kinect is a 12-week intervention occurring for 90-minute sessions, 3 times per week. During each 90-minute intervention session, adolescents will engage in 60-minute bouts of aerobic gaming. Adolescents attending an exergaming session will attend concurrently."
676706|NCT02003638|B3|Baseline|Total|Total of all reporting groups
676707|NCT02003638|B2|Baseline|Placebo|Placebo taken orally every day for 12 weeks
676708|NCT02003638|B1|Baseline|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
676709|NCT02003638|P2|Participant Flow|Placebo|Placebo taken orally every day for 12 weeks
676710|NCT02003638|P1|Participant Flow|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
676711|NCT02003638|O2|Outcome|Placebo|Placebo taken orally every day for 12 weeks
676712|NCT02003638|O1|Outcome|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
676713|NCT02003638|E2|Reported Event|Placebo|Placebo taken orally every day for 12 weeks
676714|NCT02003638|E1|Reported Event|Niacin|Niacin titrated up to 6 grams taken orally every day for 12 weeks
676715|NCT02003534|B1|Baseline|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
676716|NCT02003534|P1|Participant Flow|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
676717|NCT02003534|O1|Outcome|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
676718|NCT02003534|E1|Reported Event|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
676719|NCT02003404|B1|Baseline|Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend barrier were peeled from control or peristomal abdominal skin after a set period at a set rate.
676720|NCT02003404|P1|Participant Flow|Abdominal Skin Barrier Peel Force|"Barrier materials were attached and peeled off control and peristomal abdominal skin.~Three commercial barrier materials (SoftFlex, FlexWear and FlexTend) were peeled from control or peristomal abdominal skin after a set period at a set rate."
676721|NCT02003404|O2|Outcome|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
676722|NCT02003404|O1|Outcome|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
676723|NCT02003404|E2|Reported Event|Peristomal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from peristomal skin after a set period at a set rate.
676724|NCT02003404|E1|Reported Event|Control Abdominal Skin Barrier Peel Force|Three commerical barrier materials, SoftFlex, FlexWear and FlexTend FlexWear barrier were peeled from abdominal skin after a set period at a set rate.
676725|NCT02003391|B3|Baseline|Total|Total of all reporting groups
676726|NCT02003391|B2|Baseline|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
676727|NCT02003391|B1|Baseline|DuoTrav|Travoprost/timolol for 8 weeks
676728|NCT02003391|P2|Participant Flow|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
676729|NCT02003391|P1|Participant Flow|DuoTrav|Travoprost/timolol for 8 weeks
676730|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
676731|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
676732|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
676733|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
676734|NCT02003391|O2|Outcome|Beta-blocker|Beta-blocker monotherapy for 4 weeks
676735|NCT02003391|O1|Outcome|DuoTrav|Travoprost/timolol for 4 weeks
676736|NCT02003391|E2|Reported Event|Beta-blocker|4 weeks of beta-blocker monotherapy, followed by 4 weeks of travoprost/timolol
676737|NCT02003391|E1|Reported Event|DuoTrav|Travoprost/timolol for 8 weeks
676738|NCT02003352|B1|Baseline|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.~The study population consisted of 98 combat veterans who had suffered aT BI with PTSD, referred to our study by Veteran’s groups. All subjects were male with a mean age of 39 years with a minimum age of 20 years and a maximum age of 60 years.They all met the inclusion requirements and did not have any of the exclusion requirements."
676739|NCT02003352|P1|Participant Flow|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
676740|NCT02003352|O1|Outcome|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
676741|NCT02003352|E1|Reported Event|Functional Neurological Rehabilitation|"Functional Neurological and physical/vestibular rehabilitation strategies~Functional Neurological Rehabilitation: Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength."
676742|NCT02003014|B1|Baseline|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676743|NCT02003014|P1|Participant Flow|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676744|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676745|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676746|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676747|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676748|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676749|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676750|NCT02003014|O1|Outcome|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676751|NCT02003014|E1|Reported Event|Pioglitazone|Pioglitazone 15 mg - 30 mg, tablet, orally, once daily for up to 12 months in participants based upon the disease severity.
676752|NCT02002936|B1|Baseline|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676753|NCT02002936|P1|Participant Flow|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676754|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676755|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676756|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676757|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676758|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
677623|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
676759|NCT02002936|O1|Outcome|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676760|NCT02002936|E1|Reported Event|SyB C-1101|"SyB C-1101 （rigosertib sodium）:~Following Cycle 6 of Study 2012002, the treatment in this study was initiated. One cycle was defined as a 21-day cycle; 14-day oral administration of SyB C-1101 twice daily (Days 1 to 14) followed by a 1-week observation period (Days 15 to 21). The starting dose of SyB C-1101 in this study (Cycle 7) was the same as that was determined for the next cycle in Cycle 6 of Study 2012002."
676761|NCT02002871|B1|Baseline|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
676762|NCT02002871|P1|Participant Flow|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
676763|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676764|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676765|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676766|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676767|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676768|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676769|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676770|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676771|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676772|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676773|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676774|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676775|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676776|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676777|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676778|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676779|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676780|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676781|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676782|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676783|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676784|NCT02002871|O2|Outcome|Control|Contralateral untreated control plaque on the same patient.
676785|NCT02002871|O1|Outcome|Blue Light|"Light wavelength 453nm~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light."
676786|NCT02002871|E1|Reported Event|Blue Light vs Control|"Light wavelength 453nm, compared to contralateral untreated control plaque on the same patient.~PSO-CT02 device: The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control."
676787|NCT02002702|B4|Baseline|Total|Total of all reporting groups
676788|NCT02002702|B3|Baseline|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676789|NCT02002702|B2|Baseline|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676790|NCT02002702|B1|Baseline|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676791|NCT02002702|P3|Participant Flow|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676792|NCT02002702|P2|Participant Flow|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676793|NCT02002702|P1|Participant Flow|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676794|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676795|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
677624|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
676796|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676797|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676798|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676799|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676800|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676801|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676802|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676803|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676804|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676805|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676806|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676807|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676808|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676809|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676810|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676811|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676812|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676813|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676814|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676815|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676816|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676817|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676818|NCT02002702|O3|Outcome|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676819|NCT02002702|O2|Outcome|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676820|NCT02002702|O1|Outcome|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676821|NCT02002702|E3|Reported Event|Placebo|Participants received continuous i.v. infusion of placebo matched to serelaxin for 48 hours.
676822|NCT02002702|E2|Reported Event|Serelaxin 30 mcg/kg/Day|Participants received 30 mcg/kg/day serelaxin as continuous i.v. infusion for 48 hours.
676823|NCT02002702|E1|Reported Event|Serelaxin 10 mcg/kg/Day|Participants received 10 micrograms/kilogram/day (mcg/kg/day) serelaxin as continuous intravenous (i.v.) infusion for 48 hours.
676824|NCT02002689|B1|Baseline|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
676825|NCT02002689|P1|Participant Flow|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
676826|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
676827|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
676828|NCT02002689|O1|Outcome|Sonidegib|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
676829|NCT02002689|E1|Reported Event|LDE225|All the patients received sonidegib on a flat scale of 800 mg (e.g., 4 x 200 mg hard gelatin capsules) once daily on a continuous dosing cycle.
676830|NCT02002650|B3|Baseline|Total|Total of all reporting groups
676831|NCT02002650|B2|Baseline|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
676832|NCT02002650|B1|Baseline|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-operational rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
676833|NCT02002650|P2|Participant Flow|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
676834|NCT02002650|P1|Participant Flow|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
676835|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin for high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just for high-risk patients."
676836|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
676837|NCT02002650|O2|Outcome|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
676838|NCT02002650|O1|Outcome|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
676839|NCT02002650|E2|Reported Event|Post-ERCP Group|"Post-ERCP rectal Indomethacin in high-risk patients.~Post-ERCP Rectal Indomethacin: Rectal Indomethacin was administrated immediately after ERCP just in high-risk patients, while average risk patients did not."
676840|NCT02002650|E1|Reported Event|Pre-ERCP Group|"Pre-ERCP rectal Indomethacin in all patients.~Pre-ERCP rectal Indomethacin: Rectal Indomethacin was administrated within 30min before ERCP in all patients."
676841|NCT02002221|B3|Baseline|Total|Total of all reporting groups
676842|NCT02002221|B2|Baseline|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676843|NCT02002221|B1|Baseline|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676844|NCT02002221|P2|Participant Flow|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676845|NCT02002221|P1|Participant Flow|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676846|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676847|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676848|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676849|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676850|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676851|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676852|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676853|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676854|NCT02002221|O2|Outcome|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676855|NCT02002221|O1|Outcome|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676856|NCT02002221|E2|Reported Event|Placebo|In this arm, patients received vildagliptin 50 mg matching placebo tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676857|NCT02002221|E1|Reported Event|Vildagliptin (LAF237)|Patients received vildagliptin (LAF237) 50 mg tablets twice daily for 12 weeks. Patients continued on a stable dose of long-acting or intermediate-acting or pre-mixed insulin, and metformin if applicable, throughout the study
676858|NCT02002208|B3|Baseline|Total|Total of all reporting groups
676859|NCT02002208|B2|Baseline|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
676860|NCT02002208|B1|Baseline|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
676861|NCT02002208|P2|Participant Flow|Placebo Tablets|"Orally once a day~OC000459: CRTH2 inhibitor"
676862|NCT02002208|P1|Participant Flow|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
676863|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
676864|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
676865|NCT02002208|O2|Outcome|Placebo Tablets|Orally once a day
676866|NCT02002208|O1|Outcome|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
676867|NCT02002208|E2|Reported Event|Placebo Tablets|Orally once a day
676868|NCT02002208|E1|Reported Event|OC000459 Tablets|"50 mg orally once a day~OC000459: CRTH2 inhibitor"
676869|NCT02001181|B3|Baseline|Total|Total of all reporting groups
676870|NCT02001181|B2|Baseline|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676871|NCT02001181|B1|Baseline|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676872|NCT02001181|P2|Participant Flow|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676873|NCT02001181|P1|Participant Flow|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676874|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676875|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676876|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676877|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676878|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676879|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676880|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676881|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676882|NCT02001181|O2|Outcome|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676883|NCT02001181|O1|Outcome|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676884|NCT02001181|E2|Reported Event|Vehicle BID|Participants received placebo topical ointment vehicle to the treatment area BID for 4 weeks.
676885|NCT02001181|E1|Reported Event|Tofacitinib 20 mg/g BID|Participants received tofacitinib (20 milligrams per gram [mg/g, 2%]) topical ointment to the treatment area twice a day (BID) for 4 weeks.
676886|NCT02000973|B5|Baseline|Total|Total of all reporting groups
676887|NCT02000973|B4|Baseline|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
676888|NCT02000973|B3|Baseline|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
676889|NCT02000973|B2|Baseline|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
676890|NCT02000973|B1|Baseline|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
676891|NCT02000973|P4|Participant Flow|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
676892|NCT02000973|P3|Participant Flow|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
676893|NCT02000973|P2|Participant Flow|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
676894|NCT02000973|P1|Participant Flow|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
676895|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
676896|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
676897|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
676898|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
676899|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
676900|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
676901|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
676902|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
676903|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
676904|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
676905|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
676906|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
676907|NCT02000973|O4|Outcome|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
676908|NCT02000973|O3|Outcome|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
676909|NCT02000973|O2|Outcome|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
676910|NCT02000973|O1|Outcome|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
676911|NCT02000973|E4|Reported Event|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine 8ml
676912|NCT02000973|E3|Reported Event|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine 8ml
676913|NCT02000973|E2|Reported Event|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine 8ml
676914|NCT02000973|E1|Reported Event|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline 8ml
676915|NCT02000921|B4|Baseline|Total|Total of all reporting groups
676916|NCT02000921|B3|Baseline|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676917|NCT02000921|B2|Baseline|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
677271|NCT01997892|O1|Outcome|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
676918|NCT02000921|B1|Baseline|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
676919|NCT02000921|P3|Participant Flow|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676920|NCT02000921|P2|Participant Flow|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676921|NCT02000921|P1|Participant Flow|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
676922|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676923|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676924|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
676925|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676926|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676927|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
676928|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676929|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676994|NCT01999894|E2|Reported Event|Memantine to Memantine|Patients who received Memantine during the double-blind lead-in study continued to receive Memantine during a 6-week lead-in, followed by 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
676930|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
676931|NCT02000921|O3|Outcome|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676932|NCT02000921|O2|Outcome|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676933|NCT02000921|O1|Outcome|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
676934|NCT02000921|E3|Reported Event|VLNC With Non-combusted Products|"Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products.~VLNC cigarettes: Modified risk tobacco product~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676935|NCT02000921|E2|Reported Event|VLNC + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~VLNC cigarettes: Modified risk tobacco product~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine."
676936|NCT02000921|E1|Reported Event|CN + Combusted & Non-combusted Products|"Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time.~Combusted Products: Options for combusted tobacco products include cigars, cigarillos, and little cigars, .~Non-combusted products: Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.~CN cigarettes: Experimental cigarettes with conventional nicotine content."
676937|NCT02000752|B3|Baseline|Total|Total of all reporting groups
676938|NCT02000752|B2|Baseline|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
676939|NCT02000752|B1|Baseline|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
676940|NCT02000752|P2|Participant Flow|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
676941|NCT02000752|P1|Participant Flow|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
676942|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
677025|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677625|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
676943|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
676944|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
676945|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
676946|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
676947|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
676948|NCT02000752|O2|Outcome|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
676949|NCT02000752|O1|Outcome|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
676950|NCT02000752|E2|Reported Event|Acupuncture|"In the intervention group with real acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the point Ren Mai 6. This point is located on the anterior midline, between the umbilicus and the upper part of the pubic symphysis, at a distance of 0.3d from the umbilicus, being d the distance from the umbilicus to the upper part of the pubic symphysis. A sterilized steel needle of 0.25x40 mm is inserted in this point at 15-30 mm, depending on the adipose tissue of the woman.~Acupuncture"
676951|NCT02000752|E1|Reported Event|Sham Acupuncture|"Regarding to the control group with sham acupuncture, after the umbilical cord is clamped, the acupuncturist disinfects the abdominal area with antiseptic and pricks the needle in the placebo point with a sterilized 0.25x40 mm steel needle. The control point is located at the same horizontal level than the Ren Mai 6 point, but at 0.6d to the left of the anterior midline of the mother. In this case, the sterilized steel needle of 0.25x25 mm is inserted 15 mm into the tissue.~Sham acupuncture: Sham point acupuncture"
676952|NCT02000531|B3|Baseline|Total|Total of all reporting groups
676953|NCT02000531|B2|Baseline|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
676954|NCT02000531|B1|Baseline|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
676955|NCT02000531|P2|Participant Flow|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
676956|NCT02000531|P1|Participant Flow|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
676957|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
676958|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
676959|NCT02000531|O2|Outcome|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
676960|NCT02000531|O1|Outcome|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
676961|NCT02000531|E2|Reported Event|Chemotherapy-Erlotinib|Chemotherapy in first-line treatment, followed by erlotinib in the second-line treatment
676962|NCT02000531|E1|Reported Event|Erlotinib-Chemotherapy|Erlotinib in first-line treatment, followed by chemotherapy in the second-line treatment
676963|NCT02000440|B1|Baseline|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
677046|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
676964|NCT02000440|P1|Participant Flow|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676965|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676966|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676967|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676968|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676969|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676970|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676971|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676972|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676973|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676974|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676975|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676976|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676977|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676978|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
677026|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
676979|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676980|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676981|NCT02000440|O1|Outcome|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676982|NCT02000440|E1|Reported Event|Losmapimod 7.5 mg BID / 15 mg BID|Participants received losmapimod 7.5 mg BID (morning and evening), orally after 30 minutes (min.) of their starting meal for approximately 2 weeks. After all the pre-dose assessments at the Week 2 visit, participants received losmapimod 15 mg BID (2 tablets of 7.5 mg each, morning and evening), orally after 30 min. of their starting meal for approximately 22 weeks. Study treatment doses were separated by at least 6 hours.
676983|NCT02000154|B1|Baseline|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676984|NCT02000154|P1|Participant Flow|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676985|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676986|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676987|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676988|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676989|NCT02000154|O1|Outcome|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676990|NCT02000154|E1|Reported Event|SyB L-1101|"SyB L-1101 （rigosertib sodium for intravenous formulation）:~A 72-hour continuous intravenous dosing of SyB L-1101 4 weeks apart were administered to patients who had no disease progression of the primary disease at the end of the eighth cycle of Study 2011005, as well as those who gave consent to the continuous administration. The dose of SyB L-1101 in the ninth cycle was to be the same as that of the eighth cycle of Study 2011005 (if a dose reduction in the next cycle applied to a patient, SyB L-1101 was administered to the patient at the reduced dose)."
676991|NCT01999894|B1|Baseline|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
676992|NCT01999894|P1|Participant Flow|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
676993|NCT01999894|O1|Outcome|Memantine|Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
677044|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
676995|NCT01999894|E1|Reported Event|Placebo to Memantine|Patients who received placebo during the double-blind lead-in study, were titrated to Memantine during a 6-week lead-in to 42 weeks of Open Label Memantine - Once daily oral administration of memantine extended release. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups.
676996|NCT01999400|B1|Baseline|All Study Participants|"Participants who were randomized to one of the six arms of this study:~Arm 1: Pentasa then Delzicol then Apriso then Lialda Arm 2: Pentasa then Delzicol then Lialda then Apriso Arm 3: Apriso then Delzicol then Pentasa then Lialda Arm 4: Apriso then Delzicol then Lialda then Pentasa Arm 5: Lialda then Delzicol then Pentasa then Apriso Arm 6: Lialda then Delzicol then Apriso then Pentasa"
676997|NCT01999400|P6|Participant Flow|Arm 6: Lialda Then Delzicol Then Apriso Then Pentasa|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
676998|NCT01999400|P5|Participant Flow|Arm 5: Lialda Then Delzicol Then Pentasa Then Apriso|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose."
676999|NCT01999400|P4|Participant Flow|Arm 4: Apriso Then Delzicol Then Lialda Then Pentasa|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose."
677000|NCT01999400|P3|Participant Flow|Arm 3: Apriso Then Delzicol Then Pentasa Then Lialda|"Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
677001|NCT01999400|P2|Participant Flow|Arm 2: Pentasa Then Delzicol Then Lialda Then Apriso|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose."
677002|NCT01999400|P1|Participant Flow|Arm 1: Pentasa Then Delzicol Then Apriso Then Lialda|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose.~Washout period of 10 days.~Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose.~Washout period of 10 days.~Apriso 375 mg capsule x 3 with 240 mL water, single dose.~Washout period of 10 days.~Lialda 1200 mg tablet x 1 with 240 mL water, single dose."
677003|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
677004|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
677005|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
677006|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
677007|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
677008|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
677009|NCT01999400|O4|Outcome|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
677010|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
677011|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
677012|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
677013|NCT01999400|O4|Outcome|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
677014|NCT01999400|O3|Outcome|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
677015|NCT01999400|O2|Outcome|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
677016|NCT01999400|O1|Outcome|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
677017|NCT01999400|E4|Reported Event|Delzicol|"Delzicol 100 mg mesalamine x 1 with 245 mL water, single dose~Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose"
677018|NCT01999400|E3|Reported Event|Lialda|"Lialda 1200 mg tablet x 1 with 240 mL water, single dose~Lialda 1200 mg tablet x 1 with 240 mL water; single dose"
677019|NCT01999400|E2|Reported Event|Apriso|"Apriso 375 mg capsule x 3 with 240 mL water, single dose~Apriso 375 mg capsule x 3 with 240 mL water; single dose"
677020|NCT01999400|E1|Reported Event|Pentasa|"Pentasa 500 mg capsule x 2 with 240 mL water, single dose~Pentasa 500 mg capsule x 2 with 240 mL water; single dose"
677021|NCT01999348|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677022|NCT01999348|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677023|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677024|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677045|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677027|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677028|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677029|NCT01999348|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677030|NCT01999348|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
677031|NCT01999231|B5|Baseline|Total|Total of all reporting groups
677032|NCT01999231|B4|Baseline|20μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
677033|NCT01999231|B3|Baseline|10μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
677034|NCT01999231|B2|Baseline|5μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
677035|NCT01999231|B1|Baseline|1μg/ml ESAT6-CFP10|24 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、5μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、10μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10、20μg/ml Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10.Each dose group have six healthy subjects , at the same time set up two people for substitute (one male and one female) .
677036|NCT01999231|P4|Participant Flow|20μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes ."
677037|NCT01999231|P3|Participant Flow|10μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 10μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 20μg/ml ESAT6-CFP10 groups ."
677038|NCT01999231|P2|Participant Flow|5μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 5μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 10μg/ml ESAT6-CFP10 groups ."
677039|NCT01999231|P1|Participant Flow|1μg/ml ESAT6-CFP10|"We get 32 healthy subjects who all meet the standard of our protocol by comprehensive check-up and asked basic medical history .32 healthy subjects are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects who are injected drug , at the same time set up two people for substitute (one male and one female) .~Each participant intradermally inject only one dose of Recombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 in one third site of left or right forearm palmaris .Within the same dose group two volunteer must be interval 40 minutes .~Make sure 1μg/ml ESAT6-CFP10 group finally finished injection and observed seven days with no serious adverse reaction, then carry out 5μg/ml ESAT6-CFP10 groups ."
677040|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677041|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677042|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677043|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
712651|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
677047|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677048|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677049|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677050|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677051|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677052|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
677053|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677054|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677055|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677056|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677057|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677058|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677059|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677060|NCT01999231|O4|Outcome|20μg/ml ESAT6-CFP10|Concentration of 20 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; A single dose
677061|NCT01999231|O3|Outcome|10μg/ml ESAT6-CFP10|Concentration of 10ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677062|NCT01999231|O2|Outcome|5μg/ml ESAT6-CFP10|Concentration of 5 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677063|NCT01999231|O1|Outcome|1μg/ml ESAT6-CFP10|Concentration of 1 ug/ml;dosage form:Injection; 0.3 ml/bottle; Intradermal injection; 0.1 ml per participants; a single dose
677064|NCT01999231|E4|Reported Event|20μg/ml ESAT6-CFP10|There is no adverse event.
677065|NCT01999231|E3|Reported Event|10μg/ml ESAT6-CFP10|There is no adverse event.
677066|NCT01999231|E2|Reported Event|5μg/ml ESAT6-CFP10|"Medicine Number 2 participant 15 min and 30 min after skin test is observed local skin reactions and all found that scattered red dot (32 x 25 mm )appeared .After 30min each time point local skin reactions were negative .~This mild local skin reactions may be relevant with alcohol allergy , had nothing to do with experimental drugs by the judgement of principal investigator ."
677067|NCT01999231|E1|Reported Event|1μg/ml ESAT6-CFP10|"Medicine Number 6 participant 24 h after test skin test, is observed local skin reactions and found subcutaneous hemorrhage ( 2 x 2 mm),48 h the subcutaneous hemorrhage is remain and becomes shallow ,72 h the subcutaneous hemorrhage is the same size and becomes lower shallow ,96 h the skin reaction has faded .This mild local skin reactions may be relevant with acupuncture of skin test , had nothing to do with experimental drugs by the judgement of principal investigator .~Medicine Number 12 participant occurred two cases of adverse events the seventh days after skin test :respectively pregnancy and a small amount of pleural effusion on both sides .This volunteer test results of a pregnancy test paper were negative in screening period,pregnancy test result were positive the seventh days after the skin test."
677068|NCT01998919|B3|Baseline|Total|Total of all reporting groups
677069|NCT01998919|B2|Baseline|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677070|NCT01998919|B1|Baseline|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677071|NCT01998919|P2|Participant Flow|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677072|NCT01998919|P1|Participant Flow|Placebo Plus Chemotherapy|Participants received placebo tablets, orally (PO), on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 times [x] area under the serum concentration-time curve [AUC]), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677160|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677073|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677074|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677075|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677076|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677077|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677078|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677079|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677080|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677081|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677082|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677083|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677084|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677085|NCT01998919|O2|Outcome|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677086|NCT01998919|O1|Outcome|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677087|NCT01998919|E2|Reported Event|Erlotinib Plus Chemotherapy|Participants received erlotinib tablets, 150 mg per day, PO on Days 15 to 28 of every 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive erlotinib monotherapy, 150 mg daily.
677088|NCT01998919|E1|Reported Event|Placebo Plus Chemotherapy|Participants received placebo tablets, PO, on Days 15 to 28 of a 4-week cycle; participants also received platinum-based doublet chemotherapy: gemcitabine 1250 mg/m^2 via IV infusion on Days 1 and 8 and either cisplatin (75 mg/m^2) or carboplatin (5 x AUC), via IV infusion, per investigator discretion, on Day 1. Participants received study drugs for a maximum of 6 cycles until disease progression, unacceptable toxicity or death. After 6 cycles, participants may have continued to receive placebo tablets daily.
677089|NCT01998906|B4|Baseline|Total|Total of all reporting groups
677090|NCT01998906|B3|Baseline|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677091|NCT01998906|B2|Baseline|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677092|NCT01998906|B1|Baseline|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677093|NCT01998906|P3|Participant Flow|HER2- Doxorubicin/Paclitaxel/CMF (HER2-C)|"Participants with human epidermal growth factor receptor proto-oncogene negative (HER2-) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677094|NCT01998906|P2|Participant Flow|HER2+ Doxorubicin/Paclitaxel/CMF (HER2+C)|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677095|NCT01998906|P1|Participant Flow|HER2+ Trastuzumab/Doxorubicin/Paclitaxel/CMF (HER2+TC)|"Participants with human epidermal growth factor receptor 2 proto-oncogene positive (HER2+) breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 milligrams per kilogram (mg/kg), intravenously (IV) on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/square meter (mg/m^2), IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677096|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677097|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677098|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677099|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677100|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677101|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677102|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677103|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677104|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677105|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677106|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677107|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677108|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677109|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677110|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677161|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677111|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677112|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677113|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677114|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677115|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677116|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677117|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received doxorubicin, paclitaxel, and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
677118|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received doxorubicin, paclitaxel and CMF as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Day 1, followed by 2 weeks off."
677119|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677120|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677121|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677122|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677162|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677123|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677124|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677125|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677126|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677127|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677128|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677129|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677130|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677131|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677132|NCT01998906|O3|Outcome|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677133|NCT01998906|O2|Outcome|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677134|NCT01998906|O1|Outcome|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, on Day 1 and cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Days 1 and 8, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Day 1, followed by 2 weeks off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677163|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677135|NCT01998906|E3|Reported Event|HER2- C|"Participants with HER2- breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677136|NCT01998906|E2|Reported Event|HER2+ C|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): doxorubicin 60 mg/m^2, IV and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, on Days 1 and 8, followed by 1 week off."
677137|NCT01998906|E1|Reported Event|HER2+ TC|"Participants with HER2+ breast cancer received treatment as follows:~Cycles 1-3 (3-week cycles): trastuzumab 8 mg/kg, IV on Day 1 (Cycle 1 only; 6 mg/kg in Cycles 2 and 3), doxorubicin 60 mg/m^2, IV, and paclitaxel 150 mg/m^2, IV, on Day 1 followed by 2 weeks off.~Cycles 4-7 (3-week cycles): trastuzumab 6 mg/kg, IV, paclitaxel 175 mg/m^2, IV, on Day 1, followed by 2 weeks off.~Cycles 8-10 (3-week cycles): trastuzumab 6 mg/kg, IV, cyclophosphamide 600 mg/m^2, IV, methotrexate 40 mg/m^2, IV, and 5-fluorouracil 600 mg/m^2, IV, (collectively CMF) on Day 1, followed by 2 weeks off.~Cycles 11-17 (3-week cycles): postoperatively, participants received trastuzumab 6 mg/kg IV on Days 1 and 8, followed by 1 week off for maximum of 17 overall cycles with trastuzumab. Adjuvant tamoxifen, 20 mg/day was administered for up to 5 years."
677138|NCT01998893|B1|Baseline|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677139|NCT01998893|P1|Participant Flow|Rituximab|Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677140|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677141|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677142|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677143|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677144|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677145|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677146|NCT01998893|O1|Outcome|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677147|NCT01998893|E1|Reported Event|Rituximab|Participants received rituximab, 375 mg/m^2, IV, over 4 hours, once per week for 4 weeks. Responders were eligible to receive a second course of treatment after relapse.
677148|NCT01998880|B3|Baseline|Total|Total of all reporting groups
677149|NCT01998880|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677150|NCT01998880|B1|Baseline|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677151|NCT01998880|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677152|NCT01998880|P1|Participant Flow|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677153|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677154|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677155|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677156|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677157|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677158|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677159|NCT01998880|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677164|NCT01998880|O1|Outcome|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677165|NCT01998880|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
677166|NCT01998880|E1|Reported Event|Rituximab + Chlorambucil (RClb)|Participants received 375 mg/m^2 rituximab IV infusion on Day 1 of Cycle 1 then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 cycles).
677167|NCT01998581|B3|Baseline|Total|Total of all reporting groups
677168|NCT01998581|B2|Baseline|Restylane-L®|Lips injected with Restylane-L®
677169|NCT01998581|B1|Baseline|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
677170|NCT01998581|P2|Participant Flow|Restylane-L®|Lips injected with Restylane-L®
677171|NCT01998581|P1|Participant Flow|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
677172|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
677173|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
677174|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
677175|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
677176|NCT01998581|O2|Outcome|Restylane-L®|Lips injected with Restylane-L®
677177|NCT01998581|O1|Outcome|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
677178|NCT01998581|E2|Reported Event|Restylane-L®|Lips injected with Restylane-L®
677179|NCT01998581|E1|Reported Event|JUVEDERM VOLBELLA® XC|Lips injected with JUVEDERM VOLBELLA® XC
677180|NCT01998477|B3|Baseline|Total|Total of all reporting groups
677181|NCT01998477|B2|Baseline|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677182|NCT01998477|B1|Baseline|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677183|NCT01998477|P2|Participant Flow|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677184|NCT01998477|P1|Participant Flow|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677185|NCT01998477|O8|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
677186|NCT01998477|O7|Outcome|TIV_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
677187|NCT01998477|O6|Outcome|TIV_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
677188|NCT01998477|O5|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677189|NCT01998477|O4|Outcome|TIVc_Non Naive (3 to <9 Years)|Vaccine non naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677190|NCT01998477|O3|Outcome|TIVc_Naive (3 to <9 Years)|Vaccine naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677191|NCT01998477|O2|Outcome|TIV (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677192|NCT01998477|O1|Outcome|TIVc (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677193|NCT01998477|O14|Outcome|TIV_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
677194|NCT01998477|O13|Outcome|TIVc_Non Naive (9 to <18 Years)|Vaccine nonnaïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677195|NCT01998477|O12|Outcome|TIV_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677196|NCT01998477|O11|Outcome|TIV_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677197|NCT01998477|O10|Outcome|TIV_Non Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
677198|NCT01998477|O9|Outcome|TIVc_Naive_inj 2 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677199|NCT01998477|O8|Outcome|TIVc_Naive_inj 1 (≥ 6 to < 9 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677200|NCT01998477|O7|Outcome|TIVc_Non naive_Inj 1 (≥ 6 to < 9 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677201|NCT01998477|O6|Outcome|TIV_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677202|NCT01998477|O5|Outcome|TIV_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677203|NCT01998477|O4|Outcome|TIV_Non naive_inj 1 (3 to <6 Years)|Vaccine nonnaïve subjects received one dose of egg derived trivalent subunit influenza vaccine formulation (TIV)
677204|NCT01998477|O3|Outcome|TIVc_naive_inj 2 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677205|NCT01998477|O2|Outcome|TIVc_naive_inj 1 (3 to <6 Years)|Vaccine naïve subjects received two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677206|NCT01998477|O1|Outcome|TIVc_Non naive_inj 1 (3 to <6 Years)|Vaccine non-naïve subjects received one dose of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677207|NCT01998477|O4|Outcome|TIV_inj 2 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677208|NCT01998477|O3|Outcome|TIV_inj 1 (3 to <18 Years)|Vaccine naïve and non-naive subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677209|NCT01998477|O2|Outcome|TIVc_inj 2 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677210|NCT01998477|O1|Outcome|TIVc _inj 1 (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc)
677211|NCT01998477|E3|Reported Event|Total|Total Number of subjects
677212|NCT01998477|E2|Reported Event|TIV (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of egg derived trivalent subunit influenza vaccine formulation (TIV)
677213|NCT01998477|E1|Reported Event|TIVc (3 to <18 Years)|Vaccine naive and non-naïve subjects received one or two doses of cell culture derived trivalent subunit influenza vaccine formulation (TIVc).
677214|NCT01998438|B4|Baseline|Total|Total of all reporting groups
677215|NCT01998438|B3|Baseline|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677216|NCT01998438|B2|Baseline|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677217|NCT01998438|B1|Baseline|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677218|NCT01998438|P3|Participant Flow|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677219|NCT01998438|P2|Participant Flow|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677220|NCT01998438|P1|Participant Flow|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677221|NCT01998438|O3|Outcome|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677222|NCT01998438|O2|Outcome|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677223|NCT01998438|O1|Outcome|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677224|NCT01998438|E3|Reported Event|Large Dose|"30mg/kg tranexamic acid add in priming fluid, 30mg/kg single shot slowly when incision, followed by 6mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677225|NCT01998438|E2|Reported Event|Medium Dose|"20mg/kg tranexamic acid add in priming fluid, 20mg/kg single shot slowly when incision, followed by 4mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677226|NCT01998438|E1|Reported Event|Small Dose|"10mg/kg tranexamic acid add in priming fluid, 10mg/kg single shot slowly when incision, followed by 2mg/(kg·h) infusion until the end of surgery~Tranexamic Acid: The loading doses were given in 15 minutes when incision."
677227|NCT01998399|B3|Baseline|Total|Total of all reporting groups
677228|NCT01998399|B2|Baseline|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
677229|NCT01998399|B1|Baseline|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
677230|NCT01998399|P2|Participant Flow|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
677231|NCT01998399|P1|Participant Flow|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
677232|NCT01998399|O2|Outcome|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
677233|NCT01998399|O1|Outcome|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
677234|NCT01998399|E2|Reported Event|Placebo|"Placebo 180 mg loading dose followed by 90 mg BID for 90 days.~Placebo: Placebo 180 mg loading dose followed by 90 mg BID for 90 days."
677235|NCT01998399|E1|Reported Event|Ticagrelor|"Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days~Ticagrelor: Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days"
677236|NCT01998360|B3|Baseline|Total|Total of all reporting groups
677237|NCT01998360|B2|Baseline|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677238|NCT01998360|B1|Baseline|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677239|NCT01998360|P2|Participant Flow|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677240|NCT01998360|P1|Participant Flow|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677241|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677242|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677243|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677244|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677245|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677246|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677247|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677248|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677249|NCT01998360|O2|Outcome|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677250|NCT01998360|O1|Outcome|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677251|NCT01998360|E2|Reported Event|Surgical Control|"Surgical circumcision using forceps guided, dorsal slit, or sleeve method~Surgical Control: The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions."
677252|NCT01998360|E1|Reported Event|Unicirc With Tissue Adhesive|"Excision of foreskin with Unicirc device and sealing wound with tissue adhesive~Unicirc with tissue adhesive: Excision of foreskin with Unicirc device and wound sealing with tissue adhesive"
677253|NCT01998269|B1|Baseline|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a scale.
677254|NCT01998269|P1|Participant Flow|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension. There are no study arms - this was a cross-sectional study to develop and validate a measure of medication self-management skills. A total of 210 patients were recruited. 17 participated in focus groups to help develop the tool. The other 193 participated in item performance testing. The results of item performance testing are reported here.
677255|NCT01998269|O1|Outcome|Adult Patients With Diabetes and Hypertension|English-speaking, adult patients with diabetes and hypertension were enrolled in the study. There are no study arms.
677256|NCT01998269|E1|Reported Event|Adult Patients With Diabetes and Hypertension|There are no study arms. This was a cross-sectional study to develop a medication self-management scale.
677257|NCT01997905|B1|Baseline|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677258|NCT01997905|P1|Participant Flow|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677259|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677260|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677261|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677262|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677263|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677264|NCT01997905|O1|Outcome|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677265|NCT01997905|E1|Reported Event|AtriClip LAA Exclusion Device|"AtriClip delivered via minimally invasive surgical procedure~AtriClip LAA Exclusion Device"
677266|NCT01997892|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
677267|NCT01997892|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEGylated (PEG) epoetin beta immediately prior to being switched to darbepoetin alfa.
677268|NCT01997892|O2|Outcome|Excursions > 12.0 g/dL|Hemoglobin excursions above 12.0 g/dL
677269|NCT01997892|O1|Outcome|Excursions <10.0 g/dL|Hemoglobin excursions below 10.0 g/dL
677270|NCT01997892|O2|Outcome|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
712804|NCT01777191|B3|Baseline|Total|Total of all reporting groups
677272|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
677273|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
677274|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
677275|NCT01997892|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD on dialysis and treated with PEG epoetin beta immediately prior to being switched to darbepoetin alfa.
677276|NCT01997892|E2|Reported Event|Post-switch Period|From the date of the switch to darbepoetin alfa, until up to 6 months.
677277|NCT01997892|E1|Reported Event|Pre-switch Period|From 3 months prior to the switch until the date of the switch to darbepoetin alfa.
677278|NCT01997723|B1|Baseline|OSA Testing|"Cross-over design, single group/arm~Interventions:~One polysomnography one laboratory Portable monitoring simultaneously with polysomnography one home Portable monitoring"
677279|NCT01997723|P1|Participant Flow|Experimental|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
677280|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
677281|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
677282|NCT01997723|O1|Outcome|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
677283|NCT01997723|E1|Reported Event|OSA Testing|"Cross-over design, single group/arm~Portable monitoring for OSA diagnosis: A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA."
677284|NCT01997567|B3|Baseline|Total|Total of all reporting groups
677285|NCT01997567|B2|Baseline|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
677286|NCT01997567|B1|Baseline|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
677287|NCT01997567|P2|Participant Flow|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
677288|NCT01997567|P1|Participant Flow|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
677289|NCT01997567|O2|Outcome|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
677290|NCT01997567|O1|Outcome|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
677291|NCT01997567|E2|Reported Event|Grp 2 Placebo Block|"Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)~Placebo: Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)"
677292|NCT01997567|E1|Reported Event|Grp 1 Ropivacaine Block|"Group 1 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)~Ropivacaine: Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)"
677293|NCT01997437|B1|Baseline|Tissue-engineered Airway Transplantation|"Stem-cell seeded bioartificial tracheal scaffold~Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ"
677294|NCT01997437|P1|Participant Flow|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
677295|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
677296|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
677297|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
677298|NCT01997437|O1|Outcome|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
677299|NCT01997437|E1|Reported Event|Stem-cell Seeded Bioartificial Trachea|Stem-cell seeded bioartificial tracheal scaffold: Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
677300|NCT01997411|B6|Baseline|Total|Total of all reporting groups
677301|NCT01997411|B5|Baseline|12 to <17 Years Old IN/IM Cohort|Participants who were 12 to < 17 years old at the time of enrollment into the study randomized to receive either intramuscular glucagon or intranasal glucagon at two separate visits. Order of these visits was randomized.
677302|NCT01997411|B4|Baseline|8 to <12 Years Old Intranasal Glucagon Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of intranasal glucagon at two separate visits. Order of these visits was randomized.
677303|NCT01997411|B3|Baseline|8 to <12 Years Old Intramuscular Glucagon Cohort|Participants who were 8 to < 12 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
677304|NCT01997411|B2|Baseline|4 to <8 Years Old Intranasal Glucagon Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive 2.0 or 3.0 mg of intranasal glucagon at two separate visits. Order of these visits was randomized.
677305|NCT01997411|B1|Baseline|4 to <8 Years Old Intramuscular Glucagon Cohort|Participants who were 4 to < 8 years old at the time of enrollment into the study randomized to receive only the intramuscular glucagon at one visit.
677306|NCT01997411|P8|Participant Flow|12 to <17 Years IM Glucagon 1st Visit/IN Glucagon 2nd Visit|"At the first visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.~At the second visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
677307|NCT01997411|P7|Participant Flow|12 to <17 Years IN Glucagon 1st Visit/IM Glucagon 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution."
677460|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
677308|NCT01997411|P6|Participant Flow|8 to <12 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
677309|NCT01997411|P5|Participant Flow|8 to <12 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
677310|NCT01997411|P4|Participant Flow|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677311|NCT01997411|P3|Participant Flow|4 to <8 Years IN Glucagon 3.0 mg 1st Visit/2.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
677312|NCT01997411|P2|Participant Flow|4 to <8 Years IN Glucagon 2.0 mg 1st Visit/3.0 mg 2nd Visit|"At the first visit, an intranasal (IN) glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, an IN glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
677313|NCT01997411|P1|Participant Flow|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were given an intramuscular (IM) dose of 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677314|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677315|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677316|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677317|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677318|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677319|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677320|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677321|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677322|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677323|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677324|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677325|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677326|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677327|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677328|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677329|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677330|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677331|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677332|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677333|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677334|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677335|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677336|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677337|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677338|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677339|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677340|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677341|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677342|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677343|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677344|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
719077|NCT01744197|O1|Outcome|Synera|Treated with Synera.
677345|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677346|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677347|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677348|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677349|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677350|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677351|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677352|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677353|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677354|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677355|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677356|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677357|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677358|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677359|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677360|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677361|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677362|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677363|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677364|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677365|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677366|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677367|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677368|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677369|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677370|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677371|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677372|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677373|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677374|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677375|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677376|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677377|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677378|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677379|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677380|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677381|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677382|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677383|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677384|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
719078|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
677385|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677386|NCT01997411|O8|Outcome|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677387|NCT01997411|O7|Outcome|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677388|NCT01997411|O6|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677389|NCT01997411|O5|Outcome|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677390|NCT01997411|O4|Outcome|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677391|NCT01997411|O3|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677392|NCT01997411|O2|Outcome|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677393|NCT01997411|O1|Outcome|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677394|NCT01997411|E8|Reported Event|12 to<17 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677395|NCT01997411|E7|Reported Event|12 to <17 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution.
677396|NCT01997411|E6|Reported Event|8 to<12 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677397|NCT01997411|E5|Reported Event|8 to<12 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 8.0 to less than 12.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677398|NCT01997411|E4|Reported Event|8 to <12 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677399|NCT01997411|E3|Reported Event|4 to<8 Years Old Intranasal Glucagon Visit 3.0 mg|A glucagon dose of 3.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 30 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677400|NCT01997411|E2|Reported Event|4 to<8 Years Old Intranasal Glucagon Visit 2.0 mg|A glucagon dose of 2.0 mg for participants 4.0 to less than 8.0 years of age (equivalent to 20 mg of AMG504-1 dry powder) was administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677401|NCT01997411|E1|Reported Event|4 to<8 Years Old Intramuscular Glucagon Visit|Participants who weighed at least 25 kg (55) lbs were dosed 1 mg of recombinant human glucagon United States Pharmacopeia (USP) which was constituted in the commercially provided prefilled disposable syringe containing 1 mL of diluting solution. For participants who weighed less than 25 kg, the dose was 0.5 mg constituted in 1 mL of diluting solution. This was completed at one visit and was the only visit for this cohort.
677402|NCT01997398|B1|Baseline|DBS Under General Anesthesia|Patients with advanced Parkinson's disease who underwent bilateral globus pallidus interna (GPi) deep brain stimulation surgery under general anesthesia without the use of microelectrode recordings or intraoperative stimulation.
677403|NCT01997398|P1|Participant Flow|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
677404|NCT01997398|O2|Outcome|Post - DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
677461|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677405|NCT01997398|O1|Outcome|Pre-DBS Bilateral GPi DBS Surgery Under General Anesthesia|Patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
677406|NCT01997398|O4|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients who underwent bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
677407|NCT01997398|O3|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia On Med"|"On medication scores of patients scheduled for bilateral GPi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
677408|NCT01997398|O2|Outcome|"Post-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off medication UPDRS III scores of patients who underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy."
677409|NCT01997398|O1|Outcome|"Pre-DBS Bilateral GPi DBS Under General Anesthesia Off Med"|"Off  medication UPDRS III scores of patients scheduled for bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.~Off medication ."
677410|NCT01997398|E1|Reported Event|Bilateral GPi DBS Surgery Under General Anesthesia|Patients underwent bilateral Gpi DBS surgery under general anesthesia using intraoperative computed tomography to assess lead placement accuracy.
677411|NCT01997216|B1|Baseline|Overall|Delefilcon A multifocal contact lenses and lotrafilcon B multifocal contact lenses, worn as randomized for 9 hours each.
677412|NCT01997216|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Lotrafilcon B multifocal contact lenses, followed by delefilcon A multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
677413|NCT01997216|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Delefilcon A multifocal contact lenses, followed by lotrafilcon B multifocal contact lenses, as randomized. Each product was worn bilaterally (in both eyes) for 9 hours. The wear periods were separated by 2 ± 1 days.
677414|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677415|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677416|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677417|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677418|NCT01997216|O2|Outcome|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677419|NCT01997216|O1|Outcome|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677420|NCT01997216|E2|Reported Event|AOAMF|Lotrafilcon B multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677421|NCT01997216|E1|Reported Event|Delefilcon A MF|Delefilcon A multifocal contact lenses worn bilaterally (in both eyes) for 9 hours
677422|NCT01996904|B3|Baseline|Total|Total of all reporting groups
677423|NCT01996904|B2|Baseline|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
677424|NCT01996904|B1|Baseline|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
677425|NCT01996904|P2|Participant Flow|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
677426|NCT01996904|P1|Participant Flow|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
677427|NCT01996904|O2|Outcome|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
677462|NCT01996709|O4|Outcome|Habitual MPS, Left Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
677463|NCT01996709|O3|Outcome|Habitual MPS, Right Eye|Habitual contact lens solution used with habitual contact lenses for 90 days
677464|NCT01996709|O2|Outcome|Clear Care, Left Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677465|NCT01996709|O1|Outcome|Clear Care, Right Eye|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677428|NCT01996904|O1|Outcome|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
677429|NCT01996904|E2|Reported Event|Arthroscopic Debridement|Anterosuperior portal was made for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was also performed. The superior aspect of the tendon was freed. from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
677430|NCT01996904|E1|Reported Event|Arthroscopic Repair|"Lateral-anterosuperior portal (“Miracle Portal”) was used to repair subscapularis tendon. Bursa anterior to the subscapularis tendon was usually removed for the accurate positioning of the suture-hook. Subscapularis tendon was released, pulled and sutured with suture-hook. One or two suture anchors of Modified Mason-Allen technique was used to secure the tendon.~arthroscopic repair: If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures."
677431|NCT01996813|B1|Baseline|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
677432|NCT01996813|P1|Participant Flow|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
677433|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
677434|NCT01996813|O1|Outcome|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
677435|NCT01996813|E1|Reported Event|Compression Hose|"All patients in this observational cohort study will wear compression hose during shoulder arthroscopy in the beach chair position to determine the effect of the stockings on the incidence of cerebral desaturation events during surgery.~Compression Hose: Intervention in this case is placement of compression hose on patients"
677436|NCT01996748|B3|Baseline|Total|Total of all reporting groups
677437|NCT01996748|B2|Baseline|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
677438|NCT01996748|B1|Baseline|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
677439|NCT01996748|P2|Participant Flow|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
677440|NCT01996748|P1|Participant Flow|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
677441|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
677442|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
677443|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
677444|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
677445|NCT01996748|O2|Outcome|Placebo|Two administrations daily for 7 days
677446|NCT01996748|O1|Outcome|DF277|Two administrations daily for 7 days
677447|NCT01996748|O2|Outcome|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
677448|NCT01996748|O1|Outcome|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
677449|NCT01996748|E2|Reported Event|Placebo|"Two administrations daily for 7 days~Placebo: Two administrations daily for 7 days"
677450|NCT01996748|E1|Reported Event|DF277|"Two administrations daily for 7 days~DF277: Two administrations daily for 7 days"
677451|NCT01996709|B3|Baseline|Total|Total of all reporting groups
677452|NCT01996709|B2|Baseline|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
677453|NCT01996709|B1|Baseline|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677454|NCT01996709|P2|Participant Flow|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
677455|NCT01996709|P1|Participant Flow|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677456|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
677457|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677458|NCT01996709|O2|Outcome|Habitual MPS|Habitual contact lens solution used with habitual contact lenses for 90 days
677459|NCT01996709|O1|Outcome|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677626|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677467|NCT01996709|E1|Reported Event|Clear Care|Hydrogen peroxide-based contact lens solution used with habitual contact lenses for 90 days
677468|NCT01996410|B9|Baseline|Total|Total of all reporting groups
677469|NCT01996410|B8|Baseline|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677470|NCT01996410|B7|Baseline|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677471|NCT01996410|B6|Baseline|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677472|NCT01996410|B5|Baseline|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677473|NCT01996410|B4|Baseline|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677474|NCT01996410|B3|Baseline|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677475|NCT01996410|B2|Baseline|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677476|NCT01996410|B1|Baseline|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677477|NCT01996410|P8|Participant Flow|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677478|NCT01996410|P7|Participant Flow|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677527|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
677627|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677630|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677479|NCT01996410|P6|Participant Flow|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677480|NCT01996410|P5|Participant Flow|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677481|NCT01996410|P4|Participant Flow|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677482|NCT01996410|P3|Participant Flow|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677483|NCT01996410|P2|Participant Flow|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677484|NCT01996410|P1|Participant Flow|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (“acupuncture”) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677485|NCT01996410|O2|Outcome|Standard of Care- No Acupuncture|
677486|NCT01996410|O1|Outcome|Acupuncture|
677487|NCT01996410|E8|Reported Event|Chemotherapy 4 No Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677488|NCT01996410|E7|Reported Event|Chemotherapy 4 Acupuncture|"Chemotherapy 4: In the neoadjuvant setting- This group will receive Taxotere (75 mg/m2), Carboplatin (AUC 6), Perjeta (840 mg loading fixed dose, followed by 420 mg maintenance fixed dose) day 1 every 3 weeks for 6 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Carboplatin/Perjeta treatment for a total of 6 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 6 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677489|NCT01996410|E6|Reported Event|Chemotherapy 3 No Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677490|NCT01996410|E5|Reported Event|Chemotherapy 3 Acupuncture|"Chemotherapy 3: In the adjuvant setting- This group will receive Taxotere (75mg/m2) and Cytoxan (600 mg/m2) on day 1 every 3 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every Taxotere/Cytoxan for a total of 4 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 4 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677491|NCT01996410|E4|Reported Event|Chemotherapy 2 No Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677628|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677492|NCT01996410|E3|Reported Event|Chemotherapy 2 Acupuncture|"Chemotherapy 2: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) on day 1 every 2 weeks for 4 cycles followed by Taxol (80mg/m2) on day 1 weekly for 12 cycles. Patients who randomize to the experimental (acupuncture) group will undergo acupuncture the morning of every treatment day of the adriamycin/cytoxan cycles; they will receive acupuncture for every third Taxol treatment, beginning with the first treatment. They will receive a total of 8 acupuncture sessions: 4 with the adriamycin/cytoxan cycles and 4 with the Taxol cycles. Both groups will fill out MDASI on day 3 (+/- 1 days) of each Adriamycin/Cytoxan cycle; they will also fill out the MDASI on day 3 (+/- 1 days) of every third Taxol treatment for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677493|NCT01996410|E2|Reported Event|Chemotherapy 1 No Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677494|NCT01996410|E1|Reported Event|Chemotherapy 1 Acupuncture|"Chemotherapy 1: This group will receive Adriamycin (60mg/m2) and Cytoxan (600mg/m2) concurrently on day 1 every 2 weeks for 4 cycles followed by Taxol (175mg/m2) on day 1 every 2 weeks for 4 cycles. Patients on this regimen who randomize to the experimental (acupuncture) group will undergo acupuncture on the morning of every treatment for a total of 8 acupuncture sessions. Both groups will complete a MDASI on day 3 (+/- 1 days) of each cycle of chemotherapy for a total of 8 MDASI forms.~Acupuncture~No Acupuncture- Standard of Care"
677495|NCT01996332|B1|Baseline|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
677496|NCT01996332|P1|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|Participants received erlotinib 150 milligrams/day (mg/day), orally, until progressive disease or unacceptable toxicity.
677497|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
677498|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
677499|NCT01996332|O1|Outcome|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
677500|NCT01996332|E1|Reported Event|Erlotinib 150 mg/Day|Participants received erlotinib 150 mg/day, orally, until progressive disease or unacceptable toxicity.
677501|NCT01996319|B3|Baseline|Total|Total of all reporting groups
677502|NCT01996319|B2|Baseline|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
677503|NCT01996319|B1|Baseline|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
677504|NCT01996319|P2|Participant Flow|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
677505|NCT01996319|P1|Participant Flow|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
677506|NCT01996319|O2|Outcome|Placebo|
677507|NCT01996319|O1|Outcome|QVA149|
677508|NCT01996319|O2|Outcome|Placebo|
677509|NCT01996319|O1|Outcome|QVA149|
677510|NCT01996319|O2|Outcome|Placebo|
677511|NCT01996319|O1|Outcome|QVA149|
677512|NCT01996319|O2|Outcome|Placebo|
677513|NCT01996319|O1|Outcome|QVA149|
677514|NCT01996319|O2|Outcome|Placebo|
677515|NCT01996319|O1|Outcome|QVA149|
677516|NCT01996319|O2|Outcome|Placebo|
677517|NCT01996319|O1|Outcome|QVA149|
677518|NCT01996319|O2|Outcome|Placebo|
677519|NCT01996319|O1|Outcome|QVA149|
677520|NCT01996319|O2|Outcome|Placebo|
677521|NCT01996319|O1|Outcome|QVA149|
677522|NCT01996319|E2|Reported Event|Placebo Then QVA149|Placebo once a day during 22 days cross-over to QVA149 once a day for 22 days
677523|NCT01996319|E1|Reported Event|QVA149 Then Placebo|QVA149 once a day during 22 days cross-over to placebo once a day for up to 22 days
677524|NCT01995461|B1|Baseline|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
677525|NCT01995461|P1|Participant Flow|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
677526|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
677549|NCT01995357|E2|Reported Event|Test B + Training Test B|"Test Product B was used both during part one of the study (Test B) and part two (Training Test B) hence adverse events are reported collectively for Test Product B.~Consequently, Test Product B is used for two periods compared to Standard care which has been used for only one."
677528|NCT01995461|O1|Outcome|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
677529|NCT01995461|E1|Reported Event|BTESI|"a prospective, non-randomized, case series investigating bilateral transforaminal epidural steroid injections (BTESI)~bilateral transforaminal epidural steroid injections: BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection."
677530|NCT01995357|B1|Baseline|All Subjects|Baseline data is summarized for all subjects
677531|NCT01995357|P6|Participant Flow|First Standard Product, Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test B; Coloplast Test A; ; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
677532|NCT01995357|P5|Participant Flow|First Standard Product; Then Coloplast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Standard product; Coloplast Test A; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
677533|NCT01995357|P4|Participant Flow|First Coloplast Test B; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test b; Standard product; Coloplast Test A; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
677534|NCT01995357|P3|Participant Flow|First Coloplast Test B; Then Colopast Test A|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test B; Coloplast Test A; Standard product; Training + Coloplast Test B; Training + Coloplast Test A~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
677535|NCT01995357|P2|Participant Flow|First Coloplast Test A; Then Standard Product|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Standard product; Coloplast Test B; ; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
677536|NCT01995357|P1|Participant Flow|First Coloplast Teast A; Then Coloplast Test B|"There are six arms in this study. The first part of the study investigated the two test products and one comparator product. In the second part of the study the subjects test the two test products again but receive training meanwhile.~The test sequence in this arm is:~Coloplast Test A; Coloplast Test B; Standard product; Training + Coloplast Test A; Training + Coloplast Test B~Coloplast Test A: Coloplast Test A is a newly developed ostomy appliance~Coloplast Test B: Coloplast Test B is a newly developed ostomy appliance.~Standard product: Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation."
677537|NCT01995357|O11|Outcome|Ileostomy, Standard Care (SenSura)|
677538|NCT01995357|O10|Outcome|Ileostomy, Training + Test B|
677539|NCT01995357|O9|Outcome|Ileostomy, Test B|
677540|NCT01995357|O8|Outcome|Ileostomy, Training + Test A|
677541|NCT01995357|O7|Outcome|Ileostomy, Test A|
677542|NCT01995357|O6|Outcome|Colostomy, Standard Care (SenSura)|
677543|NCT01995357|O5|Outcome|Colostomy, Standard Care (SenSura Mio)|
677544|NCT01995357|O4|Outcome|Colostomy, Training + Test B|
677545|NCT01995357|O3|Outcome|Colostomy, Test B|
677546|NCT01995357|O2|Outcome|Colostomy, Training + Test A|
677547|NCT01995357|O1|Outcome|Colostomy ,Test A|
677548|NCT01995357|E3|Reported Event|Standard Care|Standard care was used only during part one of the study. i.e. for one period only.
677617|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677618|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677550|NCT01995357|E1|Reported Event|Test A + Training Test A|"Test Product A was used both during part one of the study (Test A) and part two (Training Test A) hence adverse events are reported collectively for Test Product A.~Consequently, Test Product A is used for two periods compared to Standard care which has been used for only one."
677551|NCT01995136|B1|Baseline|TRAVATAN Z|Ophthalmic solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
677552|NCT01995136|P1|Participant Flow|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
677553|NCT01995136|O1|Outcome|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
677554|NCT01995136|E1|Reported Event|TRAVATAN Z|Ophthalmic Solution, 1 drop instilled in each eye once daily at 9PM for 3 months.
677555|NCT01995045|B3|Baseline|Total|Total of all reporting groups
677556|NCT01995045|B2|Baseline|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
677557|NCT01995045|B1|Baseline|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
677558|NCT01995045|P2|Participant Flow|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
677559|NCT01995045|P1|Participant Flow|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
677560|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
677561|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
677562|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
677563|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
677564|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
677565|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
677566|NCT01995045|O2|Outcome|Salt Solution, Bupivacaine, and Cefazolin|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/mL), 1 mL of balanced salt solution (BSS), and 1 mL cefazolin (100mg/mL) at the end of surgery.
677567|NCT01995045|O1|Outcome|Bupivicaine & Triamcinolone|Participants who were scheduled to have scleral buckle surgery, 20-gauge vitrectomy, or both were randomized to receive an injection of a 3-mL mixture of 1 mL 0.75% bupivacaine (7.5 mg/1 mL), 1 mL cefazolin (100mg/mL), and 1 mL triamcinolone (40mg/mL) at the end of surgery.
677568|NCT01995045|E2|Reported Event|Bupivicaine|"Retrobulbar anesthesia with Bupivicaine Hydrochloride~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
677569|NCT01995045|E1|Reported Event|Bupivicaine & Triamcinolone|"Retrobulbar anesthesia with Bupivicaine Hydrochloride and Triamcinolone Acetonide~Triamcinolone: Retrobulbar anesthesia~Bupivicaine Hydrochloride: Retrobulbar anesthesia"
677570|NCT01994902|B1|Baseline|Overall Study|The investigation is a cross-over investigation therefore the baseline data is given for the overall study population
677571|NCT01994902|P2|Participant Flow|First SenSura Convex Light; Then Coloplast Test Product|"The subjects test:~test period 1: SenSura Convex Light test period 2: Coloplast test product"
677572|NCT01994902|P1|Participant Flow|First Coloplast Test Product; Then SenSura Convex Light|"The subjects test:~test period 1: Coloplast test product test period 2: SenSura Convex Light"
677573|NCT01994902|O2|Outcome|SenSura Convex Light|The leakage results obtained while subjects were testing SenSura Convex Light
677574|NCT01994902|O1|Outcome|Coloplast Test Product|Leakage results obtained while subjects tested the Coloplast test product
677575|NCT01994902|E2|Reported Event|SenSura Convex Light|Adverse events reported by subjects testing SenSura Convex Light
677576|NCT01994902|E1|Reported Event|Coloplast Test Product|Adverse events reported by subjects testing Coloplast test product
677577|NCT01994876|B1|Baseline|Overall Study|All the subjects in one group
677578|NCT01994876|P2|Participant Flow|First Coloplast Test 2, Then Coloplast Test 1|"The subjects first test their own product to collect baseline measurements~The subjects are randomised to first test Coloplast Test 2 and thereafter Coloplast Test 1~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
677619|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677620|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677579|NCT01994876|P1|Participant Flow|First Coloplast Test 1, Then Coloplast Test 2|"The subjects first test their own product to collect a baseline measurement~The subjects are randomised to first test Coloplast Test 1 and thereafter Coloplast Test 2~Coloplast Test 1: Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance"
677580|NCT01994876|O3|Outcome|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
677581|NCT01994876|O2|Outcome|Coloplast Test 2|Results from subjects testing Coloplast Test 2
677582|NCT01994876|O1|Outcome|Coloplast Test 1|Results from subjects testing Coloplast Test 1
677583|NCT01994876|E3|Reported Event|Basline - Own Product|Data from subject testing own product. Measures baseline leakage
677584|NCT01994876|E2|Reported Event|Coloplast Test 2|Results from subjects testing Coloplast Test 2
677585|NCT01994876|E1|Reported Event|Coloplast Test 1|Results from subjects testing Coloplast Test 1
677586|NCT01994863|B1|Baseline|All Subjects|
677587|NCT01994863|P2|Participant Flow|First Standard Care (See Below); Then Coloplast Test Product|"The subjects are randomised to test Standard care first and thereafter test Coloplast test product.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
677588|NCT01994863|P1|Participant Flow|First Coloplast Test Product; Then Standard Care (See Below)|"The subjects are randomised to test Coloplast Test product first and thereafter test Standard Care.~Standard Care is a collection of three different already marketed 1-piece flat ostomy appliances. These are Coloplast Sensura 1-piece; Hollister: Moderma 1-piece and B.Braun Flexima 1-piece.~The three Standard Care products were tested in a 1:1:1 randomisation.~Coloplast Test product: Coloplast test product is a newly developed 1-piece ostomy appliance~Standard Care: Standard care consists of three already marketed 1-piece ostomy products~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
677589|NCT01994863|O2|Outcome|Standard Care|
677590|NCT01994863|O1|Outcome|Coloplast Test Product|
677591|NCT01994863|E2|Reported Event|Standard Care|
677592|NCT01994863|E1|Reported Event|Coloplast Test Product|
677593|NCT01994746|B1|Baseline|All Study Participants|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At another visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~The order of the visits was randomized."
677594|NCT01994746|P2|Participant Flow|Intramuscular Glucagon 1st/Intranasal Glucagon 2nd|"At the first visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~At the second visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation."
677595|NCT01994746|P1|Participant Flow|Intranasal Glucagon 1st/Intramuscular Glucagon 2nd|"At the first visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~At the second visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm."
677596|NCT01994746|O2|Outcome|Intramuscular Glucagon|"At a separate visit, 1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.~Intramuscular Glucagon"
677597|NCT01994746|O1|Outcome|Intranasal Glucagon|"At one visit, a glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.~Intranasal Glucagon"
677598|NCT01994746|E2|Reported Event|Intramuscular Glucagon|1 mg of commercially available recombinant human glucagon United States Pharmacopeia (USP) will be constituted in the provided prefilled disposable syringe containing 1 mL of diluting solution for injection into the deltoid muscle of the non-dominant arm.
677599|NCT01994746|E1|Reported Event|Intranasal Glucagon|A glucagon dose of 3 mg (equivalent to 30 mg of AMG 504-1 dry powder) will be administered in a nostril with a prefilled delivery device that delivers a single dose upon activation.
677600|NCT01994720|B3|Baseline|Total|Total of all reporting groups
677601|NCT01994720|B2|Baseline|ASA 100 mg|ASA 100 mg once daily (OD)
677602|NCT01994720|B1|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677603|NCT01994720|P2|Participant Flow|ASA 100 mg|ASA 100 mg once daily (OD)
677604|NCT01994720|P1|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677605|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677606|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677607|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677608|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677609|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677610|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677611|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677612|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677613|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677614|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677615|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677616|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677636|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677637|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677638|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677639|NCT01994720|O2|Outcome|ASA 100 mg|ASA 100 mg once daily (OD)
677640|NCT01994720|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
677641|NCT01994720|E2|Reported Event|Ticagrelor 90mg|Ticagrelor 90 mg twice daily (BD)
677642|NCT01994720|E1|Reported Event|ASA 100mg|ASA 100 mg once daily (OD)
677643|NCT01994629|B3|Baseline|Total|Total of all reporting groups
677644|NCT01994629|B2|Baseline|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677645|NCT01994629|B1|Baseline|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677646|NCT01994629|P2|Participant Flow|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-tetanus toxoid (TT) vaccine.
677647|NCT01994629|P1|Participant Flow|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-cross reactive material (CRM) vaccine.
677648|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677649|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677650|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677651|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677652|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677653|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677654|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677655|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677656|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677657|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677658|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677659|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677660|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677661|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677662|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677663|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677664|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677665|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677666|NCT01994629|O2|Outcome|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677667|NCT01994629|O1|Outcome|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677668|NCT01994629|E2|Reported Event|MenACWY-TT (12 to 15 Months Old)|Subjects received one dose of comparator MenACWY-TT vaccine.
677669|NCT01994629|E1|Reported Event|MenACWY-CRM (12 to 15 Months Old)|Subjects received one dose of investigational MenACWY-CRM vaccine.
677670|NCT01994486|B1|Baseline|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
677671|NCT01994486|P1|Participant Flow|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
677672|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
677673|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir 1125 mg capsule twice a day with Sofosbuvir 400 mg capsule once daily for 12 weeks.~In addition, sparse PK samples will be collected at week 2 and week 10."
677674|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
677675|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
677720|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
719079|NCT01744197|O1|Outcome|Synera|Treated with Synera.
677676|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|"All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks.~Telaprevir and Sofosbuvir: All subjects will have an ECG performed. Then they will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily. Both will be given for 12 weeks. In addition, PK samples will be collected at week 2 and week 10."
679055|NCT01986062|E2|Reported Event|Placebo|Placebo, administered orally, BID for one week
677677|NCT01994486|O1|Outcome|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
677678|NCT01994486|E1|Reported Event|Telaprevir and Sofosbuvir|All subjects will receive Telaprevir twice a day, 1125mg capsule and Sofosbuvir 400 mg capsule once daily for 12 weeks.
677679|NCT01994291|B4|Baseline|Total|Total of all reporting groups
677680|NCT01994291|B3|Baseline|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677681|NCT01994291|B2|Baseline|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677682|NCT01994291|B1|Baseline|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677683|NCT01994291|P3|Participant Flow|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677684|NCT01994291|P2|Participant Flow|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677685|NCT01994291|P1|Participant Flow|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677686|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677687|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677688|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677689|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677690|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677691|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677692|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677693|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677694|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677695|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677696|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677697|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677698|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677699|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677700|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677701|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677702|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677703|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677704|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677705|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677706|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677707|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677708|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677709|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677710|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677711|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677712|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677713|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677714|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677715|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677716|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677717|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677718|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677719|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
719080|NCT01744197|E2|Reported Event|Placebo|Treated with Placebo
677721|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677722|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677723|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677724|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677725|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677726|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677727|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677728|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677729|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677730|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677731|NCT01994291|O4|Outcome|Placebo QD + Ranibizumab 0.3 mg/0.5 mg|Participants received Ranibizumab 0.3 mg/0.5 mg intravitreal injection and matching placebo.
677732|NCT01994291|O3|Outcome|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677733|NCT01994291|O2|Outcome|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677734|NCT01994291|O1|Outcome|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677735|NCT01994291|E3|Reported Event|Placebo QD + Ranibizumab 0.5 mg|Participants received Ranibizumab 0.5 mg intravitreal injection and matching placebo.
677736|NCT01994291|E2|Reported Event|Placebo QD + Ranibizumab 0.3 mg|Participants received Ranibizumab 0.3 mg intravitreal injection and matching placebo.
677737|NCT01994291|E1|Reported Event|PF-04634817 200 mg QD|Participants received 50 mg tablets of PF-04634817 and masked sham therapy.
677738|NCT01993940|B3|Baseline|Total|Total of all reporting groups
677739|NCT01993940|B2|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
677740|NCT01993940|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677741|NCT01993940|P2|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
677742|NCT01993940|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677743|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
677744|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677745|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
677746|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677747|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
677748|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677749|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
677750|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677751|NCT01993940|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
677752|NCT01993940|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677753|NCT01993940|E2|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
677754|NCT01993940|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
677755|NCT01993888|B3|Baseline|Total|Total of all reporting groups
677756|NCT01993888|B2|Baseline|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
677757|NCT01993888|B1|Baseline|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
677758|NCT01993888|P2|Participant Flow|Standard of Care (SoC)|"SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).~Standard of Care (SoC)"
677759|NCT01993888|P1|Participant Flow|EVARREST Fibrin Sealant Patch|"EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).~EVARREST™ Fibrin Sealant Patch"
677760|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
677761|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
677815|NCT01992874|O3|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
677762|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
679056|NCT01986062|E1|Reported Event|AR11|AR11, administered orally, BID for one week
677763|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
677764|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
677765|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
677766|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
677767|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
677768|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
677769|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
677770|NCT01993888|O2|Outcome|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
677771|NCT01993888|O1|Outcome|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
677772|NCT01993888|E2|Reported Event|Standard of Care (SoC)|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical. For this study, SoC will be initiated with continuous firm manual compression with or without gauze or sponge and with or without a topical absorbable hemostat (example SURGICEL).
677773|NCT01993888|E1|Reported Event|EVARREST Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts — a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
677774|NCT01993823|B3|Baseline|Total|Total of all reporting groups
677775|NCT01993823|B2|Baseline|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
677776|NCT01993823|B1|Baseline|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
677777|NCT01993823|P2|Participant Flow|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
677778|NCT01993823|P1|Participant Flow|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
677779|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
677780|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
677781|NCT01993823|O2|Outcome|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
677782|NCT01993823|O1|Outcome|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
677783|NCT01993823|E2|Reported Event|Clotrimazole|"Five drops into the ear canal twice daily for 14 days~Clotrimazole: Five drops into the ear canal twice daily for 14 days"
677784|NCT01993823|E1|Reported Event|G238|"Five drops into the ear canal twice daily for 14 days~G238: Five drops into the ear canal twice daily for 14 days"
677785|NCT01993238|B1|Baseline|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
677786|NCT01993238|P1|Participant Flow|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
677816|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677817|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677787|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
677788|NCT01993238|O1|Outcome|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
677789|NCT01993238|E1|Reported Event|Liposonix With Pre-treatment Analgesia|"Liposonix System (Model 2) treatment of subcutaneous adipose tissue with pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)~Liposonix System (Model 2): Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).~Pre-treatment analgesia: Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)"
677790|NCT01993030|B3|Baseline|Total|Total of all reporting groups
677791|NCT01993030|B2|Baseline|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677792|NCT01993030|B1|Baseline|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677793|NCT01993030|P2|Participant Flow|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677794|NCT01993030|P1|Participant Flow|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677795|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677796|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677797|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677798|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677799|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677800|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677801|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677802|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677803|NCT01993030|O2|Outcome|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677804|NCT01993030|O1|Outcome|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677805|NCT01993030|E2|Reported Event|Sidaiyi® Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~Sidaiyi® wound dressing"
677806|NCT01993030|E1|Reported Event|HQ® Matrix Medical Wound Dressing|"Dressing indicated for donor site wounds. Dressing changes every 2-3 days, more frequently if needed~HQ® Matrix Medical Wound Dressing"
677807|NCT01992874|B1|Baseline|Entire Study Population|It included all the subjects randomized to receive either Pimasertib 60 mg capsule and Pimasertib 60 mg tablet first in Part A and Pimasertib 60 mg capsule in Part B of the study.
677808|NCT01992874|P3|Participant Flow|Part B:Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
677809|NCT01992874|P2|Participant Flow|Part A: Pimasertib Tablet Then Pimasertib Capsule|A single dose of 3 Pimasertib 20 mg tablet administered orally on Day 1 in first intervention period followed by a single dose of 2 Pimasertib 30 mg capsule single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
677810|NCT01992874|P1|Participant Flow|Part A: Pimasertib Capsule Then Pimasertib Tablet|A single dose of 2 Pimasertib 30 mg capsule administered orally on Day 1 in first intervention period followed by a single dose of 3 Pimasertib 20 mg tablet single dose administered orally on Day 3, of Part A of the study. A washout period of 48 hours was maintained between the administration of the two treatments.
677811|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
677812|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
677813|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
677814|NCT01992874|O1|Outcome|Part B: Pimasertib Capsule|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
677818|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677819|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677820|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
679057|NCT01985581|B3|Baseline|Total|Total of all reporting groups
677821|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677822|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677823|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677824|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677825|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677826|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677827|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677828|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677829|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677830|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677831|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study
677832|NCT01992874|O2|Outcome|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677833|NCT01992874|O1|Outcome|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677834|NCT01992874|E3|Reported Event|Part B: Pimasertib Capsule (BID)|Pimasertib 2 capsule 30 mg orally twice daily up to 4 cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
677835|NCT01992874|E2|Reported Event|Part A: Pimasertib 60 mg Tablet|A single dose of 3 Pimasertib 20 mg tablet administered orally in one of the intervention periods in part A of the study.
677836|NCT01992874|E1|Reported Event|Part A: Pimasertib 60 mg Capsule|A single dose of 2 Pimasertib 30 mg capsule administered orally in one of the intervention periods in part A of the study.
677837|NCT01992536|B11|Baseline|Total|Total of all reporting groups
677838|NCT01992536|B10|Baseline|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677839|NCT01992536|B9|Baseline|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677840|NCT01992536|B8|Baseline|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677841|NCT01992536|B7|Baseline|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
677842|NCT01992536|B6|Baseline|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677843|NCT01992536|B5|Baseline|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677844|NCT01992536|B4|Baseline|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677845|NCT01992536|B3|Baseline|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677846|NCT01992536|B2|Baseline|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677847|NCT01992536|B1|Baseline|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677848|NCT01992536|P10|Participant Flow|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677849|NCT01992536|P9|Participant Flow|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677850|NCT01992536|P8|Participant Flow|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677851|NCT01992536|P7|Participant Flow|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
677852|NCT01992536|P6|Participant Flow|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677853|NCT01992536|P5|Participant Flow|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677854|NCT01992536|P4|Participant Flow|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677855|NCT01992536|P3|Participant Flow|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677856|NCT01992536|P2|Participant Flow|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677978|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677857|NCT01992536|P1|Participant Flow|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677858|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677859|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677860|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677861|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
677862|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677863|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677864|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
677865|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677866|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677867|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677868|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677869|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677870|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677871|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
677872|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677873|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677874|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
677875|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677876|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677877|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677878|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677879|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677880|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677881|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
677882|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677883|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677884|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
677885|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677886|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677887|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677888|NCT01992536|O11|Outcome|Total|
677889|NCT01992536|O10|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677890|NCT01992536|O9|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677891|NCT01992536|O8|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677892|NCT01992536|O7|Outcome|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
677893|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677894|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677895|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677896|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677897|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677898|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677899|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677900|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677901|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677902|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677903|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677904|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
677905|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677906|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677907|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677908|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677909|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677910|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677911|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677912|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677913|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677914|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677915|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677916|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677917|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677918|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677919|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677920|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677921|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677922|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
677923|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677924|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677925|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677926|NCT01992536|O6|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677927|NCT01992536|O5|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677928|NCT01992536|O4|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677929|NCT01992536|O3|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677930|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677931|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677932|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677933|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677934|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677935|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
677936|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677937|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677938|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677939|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677940|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677941|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677942|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677943|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677944|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677945|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677946|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
677947|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677948|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677949|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677950|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677951|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677952|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677953|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677954|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677955|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677956|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677957|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677958|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677959|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677960|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677961|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677962|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677963|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677964|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677965|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677966|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677967|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677968|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677969|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677970|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677971|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677972|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677973|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677974|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677975|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677976|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677977|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677979|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677980|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
677981|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
677982|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
677983|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677984|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677985|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677986|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677987|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677988|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677989|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677990|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
677991|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
677992|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
677993|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
677994|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
677995|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
677996|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677997|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
677998|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
677999|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
678000|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
678001|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678002|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
678003|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678004|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
678005|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
678006|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
678007|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
678008|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
678009|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
678010|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678011|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
678012|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678013|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
678014|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
678015|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
678016|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
678017|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
678018|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
678019|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678020|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
678021|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678022|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
678023|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
678024|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
678025|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study.
678026|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
678027|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
678028|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678029|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
678030|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678031|NCT01992536|O9|Outcome|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
678032|NCT01992536|O8|Outcome|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼OMV in this study.
678033|NCT01992536|O7|Outcome|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
678034|NCT01992536|O6|Outcome|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼OMV in this study
678035|NCT01992536|O5|Outcome|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study
678036|NCT01992536|O4|Outcome|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study
678037|NCT01992536|O3|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678038|NCT01992536|O2|Outcome|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
678039|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678040|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
678041|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
678042|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
678043|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
678044|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
678045|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
678046|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
678047|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
678048|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
678049|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
678050|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
678051|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
678052|NCT01992536|O4|Outcome|Menveo|Subjects received a dose of placebo followed by one dose of MenACWY administered two months later.
678053|NCT01992536|O3|Outcome|rMenB+OMV|Subjects received two doses of rMenB + OMV, administered two months apart.
678054|NCT01992536|O2|Outcome|ABCWY+qOMV|Subjects received two doses of MenABCWY + qOMV administered two months apart.
678055|NCT01992536|O1|Outcome|ABCWY+OMV|Subjects received two doses of MenABCWY + OMV administered two months apart.
678056|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678057|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678058|NCT01992536|O2|Outcome|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678059|NCT01992536|O1|Outcome|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678060|NCT01992536|E11|Reported Event|Total|Total
678061|NCT01992536|E10|Reported Event|1M_Pbo|Subjects who previously received one dose of MenACWY in the parent study, received one dose of saline solution in this study.
678062|NCT01992536|E9|Reported Event|1M_qOMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
678358|NCT01990794|O2|Outcome|Male Glucose|Glucose levels before, during, and after dosing
678063|NCT01992536|E8|Reported Event|1M_OMV|Subjects who previously received one dose of MenACWY in the parent study, received one dose of MenABCWY + OMV in this study.
678064|NCT01992536|E7|Reported Event|2B_Pbo|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of Placebo in this study.
678065|NCT01992536|E6|Reported Event|2B_qOMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + ¼ OMV in this study.
678066|NCT01992536|E5|Reported Event|2B_OMV|Subjects who previously received two doses of rMenB + OMV in the parent study, received one dose of MenABCWY + OMV in this study.
678067|NCT01992536|E4|Reported Event|2qOMV_Pbo|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one dose of saline solution in this study.
678068|NCT01992536|E3|Reported Event|2qOMV_qOMV|Subjects who previously received two doses of MenABCWY + ¼ OMV in the parent study, received one booster dose of same vaccine in this study.
678069|NCT01992536|E2|Reported Event|2OMV_Pbo|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one dose of saline solution in this study.
678070|NCT01992536|E1|Reported Event|2OMV_OMV|Subjects who previously received two doses of MenABCWY + OMV in the parent study, received one booster dose of same vaccine in this study.
678071|NCT01992523|B3|Baseline|Total|Total of all reporting groups
678072|NCT01992523|B2|Baseline|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
678073|NCT01992523|B1|Baseline|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
678074|NCT01992523|P2|Participant Flow|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
678075|NCT01992523|P1|Participant Flow|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
678076|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
678077|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
678078|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
678079|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
678080|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|"Ticagrelor loading dose (LD) 180 mg as integral pills~Ticagrelor integral pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor)."
678121|NCT01992107|O8|Outcome|TIV1c_First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2,B1) recommended for 2013-2014 season
678122|NCT01992107|O7|Outcome|QIVc _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678199|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
719081|NCT01744197|E1|Reported Event|Synera|Treated with Synera.
678123|NCT01992107|O6|Outcome|TIV2c _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
680283|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
678081|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|"Ticagrelor loading dose (LD) 180 mg as mashed pills~Ticagrelor mashed pills: The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient."
678082|NCT01992523|O2|Outcome|Ticagrelor Integral Pills|
678083|NCT01992523|O1|Outcome|Ticagrelor Mashed Pills|
678084|NCT01992523|E2|Reported Event|Ticagrelor Integral Group|patients taking orally 180 mg ticagrelor integral tablets
678085|NCT01992523|E1|Reported Event|Ticagrelor Mashed Group|patients taking orally 180 mg ticagrelor mashed tablets
678086|NCT01992185|B3|Baseline|Total|Total of all reporting groups
678087|NCT01992185|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678088|NCT01992185|B1|Baseline|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
678089|NCT01992185|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678090|NCT01992185|P1|Participant Flow|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
678091|NCT01992185|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678092|NCT01992185|O1|Outcome|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
678093|NCT01992185|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678094|NCT01992185|E1|Reported Event|Photocil for Vitiligo|"Active Drug - Photocil for Vitiligo~Photocil for Vitiligo: Photocil for Vitiligo"
678095|NCT01992172|B3|Baseline|Total|Total of all reporting groups
678096|NCT01992172|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678097|NCT01992172|B1|Baseline|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
678098|NCT01992172|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678099|NCT01992172|P1|Participant Flow|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
678100|NCT01992172|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678101|NCT01992172|O1|Outcome|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
678102|NCT01992172|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
678103|NCT01992172|E1|Reported Event|Photocil for Atopic Dermatitis|"Active Drug - Photocil for Atopic Dermatitis~Photocil for Atopic Dermatitis: Photocil for Atopic Dermatitis"
678104|NCT01992107|B4|Baseline|Total|Total of all reporting groups
678105|NCT01992107|B3|Baseline|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678106|NCT01992107|B2|Baseline|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678107|NCT01992107|B1|Baseline|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678108|NCT01992107|P3|Participant Flow|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678109|NCT01992107|P2|Participant Flow|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678110|NCT01992107|P1|Participant Flow|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678111|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678112|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678113|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678114|NCT01992107|O15|Outcome|TIV2c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678115|NCT01992107|O14|Outcome|TIV1c (≥9 to <18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678116|NCT01992107|O13|Outcome|QIVc (≥9 to <18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678117|NCT01992107|O12|Outcome|TIV2c _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678118|NCT01992107|O11|Outcome|TIV1c_Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678119|NCT01992107|O10|Outcome|QIVc _Second Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678120|NCT01992107|O9|Outcome|TIV2c _First Vaccine (≥6 to <9 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678124|NCT01992107|O5|Outcome|TIV1c_Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678125|NCT01992107|O4|Outcome|QIVc _Second Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678126|NCT01992107|O3|Outcome|TIV2c _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678127|NCT01992107|O2|Outcome|TIV1c_First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678128|NCT01992107|O1|Outcome|QIVc _First Vaccine (≥4 to <6 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678129|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678130|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678131|NCT01992107|O2|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678132|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678133|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678134|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678135|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678136|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678137|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678138|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678139|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678140|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678141|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678142|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678143|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678144|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678145|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678146|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678147|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678148|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678149|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678150|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678151|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678152|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678153|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678154|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678155|NCT01992107|O3|Outcome|TIV2c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678156|NCT01992107|O2|Outcome|TIV1c (≥4 to <18 Years)|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678157|NCT01992107|O1|Outcome|QIVc (≥4 to <18 Years)|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678159|NCT01992107|E3|Reported Event|TIV2c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
725514|NCT01714635|B4|Baseline|Total|Total of all reporting groups
678160|NCT01992107|E2|Reported Event|TIV1c|Subjects received one or two doses of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678161|NCT01992107|E1|Reported Event|QIVc|Subjects received one or two doses of cell derived quadrivalent influenza vaccine (QIVc) recommended for 2013-2014 season
678162|NCT01992094|B4|Baseline|Total|Total of all reporting groups
678163|NCT01992094|B3|Baseline|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678164|NCT01992094|B2|Baseline|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
678165|NCT01992094|B1|Baseline|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678166|NCT01992094|P3|Participant Flow|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678167|NCT01992094|P2|Participant Flow|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
678168|NCT01992094|P1|Participant Flow|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678169|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678170|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678171|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678172|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678173|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678174|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678175|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678176|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678177|NCT01992094|O2|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678178|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678179|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678180|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678181|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678182|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678183|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678184|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678185|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
678186|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
678187|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678188|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678189|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678190|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678191|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
678192|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
678193|NCT01992094|O2|Outcome|QIVc (≥ 61 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678194|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678195|NCT01992094|O6|Outcome|TIV2c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678196|NCT01992094|O5|Outcome|TIV2c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678197|NCT01992094|O4|Outcome|TIV1c (≥ 61 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
678198|NCT01992094|O3|Outcome|TIV1c (18 to ≤60 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013- 2014 season
678200|NCT01992094|O1|Outcome|QIVc (18 to ≤60 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678271|NCT01991314|B2|Baseline|Adults - Ferrous Sulphate|43 adults (age >18 years) given oral ferrous sulphate 200mg bd for 6 weeks
678201|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678202|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678203|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
678204|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1) recommended for 2013-2014 season
678205|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678206|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678207|NCT01992094|O6|Outcome|TIV2c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678208|NCT01992094|O5|Outcome|TIV2c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678209|NCT01992094|O4|Outcome|TIV1c (≥ 65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1,H3N2, B1)recommended for 2013-2014 season
678210|NCT01992094|O3|Outcome|TIV1c (18 to <65 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013- 2014 season
678211|NCT01992094|O2|Outcome|QIVc (≥ 65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678212|NCT01992094|O1|Outcome|QIVc (18 to <65 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678213|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678214|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678215|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678216|NCT01992094|O3|Outcome|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678217|NCT01992094|O2|Outcome|TIV1c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678218|NCT01992094|O1|Outcome|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678219|NCT01992094|E4|Reported Event|Total|Total Number of Subjects
678220|NCT01992094|E3|Reported Event|TIV2c (≥18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV2c that contains an alternate B strain compared to what is recommended for 2013-2014
678221|NCT01992094|E2|Reported Event|TIV1c (≥ 18 Years)|Subjects received one dose of cell derived trivalent influenza vaccine TIV1c (H1N1, H3N2, B1) recommended for 2013-2014 season
678222|NCT01992094|E1|Reported Event|QIVc (≥18 Years)|Subjects received one dose of cell derived quadrivalent influenza vaccine (QIVc)
678223|NCT01991990|B3|Baseline|Total|Total of all reporting groups
678224|NCT01991990|B2|Baseline|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
678225|NCT01991990|B1|Baseline|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678226|NCT01991990|P2|Participant Flow|Tocilizumab|Participants received a single dose of intravenous (IV) tocilizumab (TCZ) at a dose of 8 milligrams (mg) per kilogram (kg) body weight infusion over 1 hour on Day 0.
678227|NCT01991990|P1|Participant Flow|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678228|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678229|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678230|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678231|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678232|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678233|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678234|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678235|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678236|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678237|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678270|NCT01991314|B3|Baseline|Total|Total of all reporting groups
678359|NCT01990794|O1|Outcome|Female Glucose|Glucose levels before, during and after dosing
678272|NCT01991314|B1|Baseline|Adolescent - Ferrous Sulphate|45 adolescents (age 13-18 years) given oral ferrous sulphate 200mg bd for 6 weeks
678238|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678239|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678240|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678241|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678242|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678243|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678244|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678245|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678246|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678247|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678248|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678249|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678250|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678251|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678252|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678253|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678254|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678255|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678256|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678257|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678258|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and >50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678259|NCT01991990|O2|Outcome|Tocilizumab (PMN-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and ≤50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678260|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678261|NCT01991990|O3|Outcome|Tocilizumab (PMN-Low Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with greater than (>) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678262|NCT01991990|O2|Outcome|Tocilizumab (Polymorphonuclear Leukocyte (PMN)]-High Group)|Participants who received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0 and with less than or equal to (≤) 50% neutrophil count decrease at Day 4 relative to baseline were included in this group.
678263|NCT01991990|O1|Outcome|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678264|NCT01991990|E2|Reported Event|Tocilizumab|Participants received a single dose of IV TCZ at a dose of 8 mg/kg body weight infusion over 1 hour on Day 0.
678265|NCT01991990|E1|Reported Event|Placebo|Participants received a single dose of placebo-matched to tocilizumab on Day 0.
678266|NCT01991548|B1|Baseline|Insulin Dependent Diabetics|individuals with insulin dependant diabetes using the 640G insulin pump for insulin infusion and continuous glucose monitoring
678267|NCT01991548|P1|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 640G insulin pump and Guardian Link transmitter.
678268|NCT01991548|O1|Outcome|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
678269|NCT01991548|E1|Reported Event|Overall|Descriptive summary will be used to characterize the results of the study questionnaires. The questionnaire will use a Likert scale (rating of 1 to 7) to assess overall subject acceptance of the MiniMed 640G and Guardian Link Transmitter. A response of 4 or greater on the Likert scale will be considered positive and indicate and product acceptance.
678273|NCT01991314|P2|Participant Flow|Adults - Ferrous Sulphate|43 adults (>18 years) given ferrous sulphate 200mg bd for 6 weeks
678274|NCT01991314|P1|Participant Flow|Adolescents - Ferrous Sulphate|45 adolescents (13-18 years) given ferrous sulphate 200mg bd for 6 weeks
678275|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
678276|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
678277|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
678278|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
678279|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
678280|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
678281|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
678282|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
678283|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
678284|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
678285|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
678286|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
678287|NCT01991314|O2|Outcome|Adults|IBD patients aged >18
678288|NCT01991314|O1|Outcome|Adolescents|Patients aged 13 - 18 years
678289|NCT01991314|E2|Reported Event|Adults|IBD patients aged >18
678290|NCT01991314|E1|Reported Event|Adolescents|Patients aged 13 - 18 years
678291|NCT01990898|B1|Baseline|Treatment|Cyclosporine
678292|NCT01990898|P1|Participant Flow|Treatment|Cyclosporine
678293|NCT01990898|O1|Outcome|Treatment|Cyclosporine
678294|NCT01990898|E1|Reported Event|Treatment|Cyclosporine
678295|NCT01990859|B1|Baseline|Ipilimumab|Participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses.
678296|NCT01990859|P1|Participant Flow|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678297|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678298|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678299|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678300|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678301|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678302|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678303|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678304|NCT01990859|O1|Outcome|Ipilimumab|During treatment, participants received Ipilimumab intravenous (IV) injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease(PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678305|NCT01990859|E1|Reported Event|Ipilimumab|During treatment, participants received Ipilimumab IV injection 3 mg/kg every 3 weeks, up to 4 doses (12 weeks). Study was divided into 4 Phases: Screening Phase, Induction Phase, Toxicity/Progressive Disease (PD) Follow Up Phase, and Overall Survival Phase. The Induction Phase consisted of treatment and a 12 week post dosing follow up. It started at first dose and ended at Week 24, or earlier if participant discontinued treatment and moved to Follow-Up Phase.
678360|NCT01990794|O2|Outcome|Male Triglycerides|Triglyceride levels before and after cobalt supplementation
678361|NCT01990794|O1|Outcome|Female Triglycerides|Triglyceride levels before and after cobalt supplementation
678306|NCT01990794|B1|Baseline|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
678307|NCT01990794|P1|Participant Flow|Study Volunteers|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
678308|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
678309|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
678310|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
678311|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
678312|NCT01990794|O4|Outcome|1 mo Postdose|Values of the sural sensory and peroneal motor variables
678313|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
678314|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
678315|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
678316|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
678317|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
678318|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
678319|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
678320|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
678321|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
678322|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select VFI variables
678323|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select VFI variables
678324|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select VFI variables
678325|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select VFI variables
678326|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select VFI variables
678327|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select VFI variables
678328|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
678329|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
678330|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
678331|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
678332|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
678333|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
678334|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select OHN variables
678335|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select OHN variables
678336|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select OHN variables
678337|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select OHN variables
678338|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select OHN variables
678339|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select OHN variables
678340|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select RNFL variables
678341|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select RNFL variables
678342|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select RNFL variables
678343|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select RNFL variables
678344|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select RNFL variables
678345|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select RNFL variables
678346|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678347|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678348|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678349|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678350|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678351|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678352|NCT01990794|O2|Outcome|Male Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
678353|NCT01990794|O1|Outcome|Female Cobalt Serum Concentrations|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
678354|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
678355|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations after cessation of cobalt supplementation
678356|NCT01990794|O2|Outcome|Male Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
678357|NCT01990794|O1|Outcome|Female Cobalt Urine Concentrations|Cobalt urine concentrations during daily oral intake of 1 mg Co.
678362|NCT01990794|O2|Outcome|Male Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
678363|NCT01990794|O1|Outcome|Female Total Cholesterol|Total cholesterol levels before and after cobalt supplementation
678364|NCT01990794|O2|Outcome|Male HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
678365|NCT01990794|O1|Outcome|Female HDL Cholesterol|HDL cholesterol levels before and after cobalt supplementation
678366|NCT01990794|O2|Outcome|Male AST|AST levels before, during, and after dosing
678367|NCT01990794|O1|Outcome|Female AST|AST levels before, during and after dosing
678368|NCT01990794|O2|Outcome|Male ALT|ALT levels before, during, and after dosing
678369|NCT01990794|O1|Outcome|Female ALT|ALT levels before, during and after dosing
678370|NCT01990794|O2|Outcome|Male Creatine|Creatine levels before, during, and after dosing
678371|NCT01990794|O1|Outcome|Female Creatine|Creatine levels before, during and after dosing
678372|NCT01990794|O2|Outcome|Male CK-MB|CK-MB levels before, during, and after dosing
678373|NCT01990794|O1|Outcome|Female CK-MB|CK-MB levels before, during and after dosing
678374|NCT01990794|O2|Outcome|Male Ferritin|Ferritin levels before, during, and after dosing
678375|NCT01990794|O1|Outcome|Female Ferritin|Ferritin levels before, during and after dosing
678376|NCT01990794|O2|Outcome|Male Total Iron|Total iron levels before, during, and after dosing
678377|NCT01990794|O1|Outcome|Female Total Iron|Total iron levels before, during and after dosing
678378|NCT01990794|O2|Outcome|Male T4|T4 levels before, during, and after dosing
678379|NCT01990794|O1|Outcome|Female T4|T4 levels before, during and after dosing
678380|NCT01990794|O2|Outcome|Male TSH|TSH levels before, during, and after dosing
678381|NCT01990794|O1|Outcome|Female TSH|TSH levels before, during and after dosing
678382|NCT01990794|O2|Outcome|Male Albumin|Albumin levels before, during, and after dosing
678383|NCT01990794|O1|Outcome|Female Albumin|Albumin levels before, during and after dosing
678384|NCT01990794|O2|Outcome|Male Protein|Protein levels before, during, and after dosing
678385|NCT01990794|O1|Outcome|Female Protein|Protein levels before, during and after dosing
678386|NCT01990794|O2|Outcome|Male Hematocrit|Hematocrit levels before, during, and after dosing
678387|NCT01990794|O1|Outcome|Female Hematocrit|Hematocrit levels before, during and after dosing
678388|NCT01990794|O2|Outcome|Male RBC|RBC levels before, during, and after dosing
678389|NCT01990794|O1|Outcome|Female RBC|RBC levels before, during and after dosing
678390|NCT01990794|O2|Outcome|Male WBC|WBC levels before, during, and after dosing
678391|NCT01990794|O1|Outcome|Female WBC|WBC levels before, during and after dosing
678392|NCT01990794|O2|Outcome|Male|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
678393|NCT01990794|O1|Outcome|Female|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
678394|NCT01990794|O3|Outcome|Study Completion|Values of the sural sensory and peroneal motor variables
678395|NCT01990794|O2|Outcome|Study Midpoint|Values of the sural sensory and peroneal motor variables
678396|NCT01990794|O1|Outcome|Prestudy|Values of the sural sensory and peroneal motor variables
678397|NCT01990794|O6|Outcome|Study Completion - Left|Values of the left eye for select ONH variables
678398|NCT01990794|O5|Outcome|Study Completion - Right|Values of the right eye for select ONH variables
678399|NCT01990794|O4|Outcome|Study Midpoint - Left|Values of the left eye for select ONH variables
678400|NCT01990794|O3|Outcome|Study Midpoint - Right|Values of the right eye for select ONH variables
678401|NCT01990794|O2|Outcome|Prestudy - Left|Values of the left eye for select ONH variables
678402|NCT01990794|O1|Outcome|Prestudy - Right|Values of the right eye for select ONH variables
678403|NCT01990794|O3|Outcome|Study Completion|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678404|NCT01990794|O2|Outcome|Study Midpoint|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678405|NCT01990794|O1|Outcome|Prestudy|Comparison of left and right ventricular function in volunteers before and after cobalt supplementation
678406|NCT01990794|O6|Outcome|Study Completion - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
678407|NCT01990794|O5|Outcome|Study Completion - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
678408|NCT01990794|O4|Outcome|Study Midpoint - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
678409|NCT01990794|O3|Outcome|Study Midpoint - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
678410|NCT01990794|O2|Outcome|Baseline - Right|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
678411|NCT01990794|O1|Outcome|Baseline - Left|Comparison of hearing function in volunteers before, during, and after cobalt supplementation
678412|NCT01990794|O2|Outcome|Male Hgb|Hgb levels before, during, and after dosing
678413|NCT01990794|O1|Outcome|Female Hgb|Hgb levels before, during and after dosing
678414|NCT01990794|O2|Outcome|SI After Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
678563|NCT01989455|E1|Reported Event|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
680284|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
678415|NCT01990794|O1|Outcome|SI Before Cobalt Supplementation|"Volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months. Metal sensitivity to metals was assessed before and after cobalt dosing by using an in vitro lymphocyte transformation test (LTT)."
678416|NCT01990794|O1|Outcome|Albumin-Co Fraction|Summary of albumin-Co fraction (SEC large molecular Co fraction) in 12 volunteers participating in the cobalt supplementation study. The average for each volunteer is based on 2 to 11 blood draws during dosing.
678417|NCT01990794|E1|Reported Event|Study Volunteers|"Study volunteers (males and females) were instructed to take the cobalt dietary supplement in the morning according to the manufacturer's label, which suggested a serving of 1 mg cobalt (~2 mL) daily in water or juice as maintenance. Dietary supplementation lasted for approximately three months."
678418|NCT01990703|B3|Baseline|Total|Total of all reporting groups
678419|NCT01990703|B2|Baseline|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
678420|NCT01990703|B1|Baseline|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
678421|NCT01990703|P2|Participant Flow|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
678422|NCT01990703|P1|Participant Flow|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
678423|NCT01990703|O2|Outcome|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
678424|NCT01990703|O1|Outcome|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
678425|NCT01990703|O2|Outcome|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
678426|NCT01990703|O1|Outcome|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
678427|NCT01990703|E2|Reported Event|Standard Postpartum Insertion Group|"Placement of the levonorgestrel IUD 4-6 weeks postpartum~Levonorgestrel IUD: Timing of IUD insertion"
678428|NCT01990703|E1|Reported Event|Early IUD Insertion Group|"Immediate post-placental placement of the levonorgestrel IUD~Levonorgestrel IUD: Timing of IUD insertion"
678429|NCT01990664|B3|Baseline|Total|Total of all reporting groups
678430|NCT01990664|B2|Baseline|Test (Senofilcon A)|Consists of subjects that were dispensed at least one Test lens.
678431|NCT01990664|B1|Baseline|Control (Senfilcon A)|Consists of subjects that were dispensed at least one Control lens.
678432|NCT01990664|P2|Participant Flow|Test (Senofilcon A)|Subjects that were randomized to receive theTest lens for the duration of the study.
678433|NCT01990664|P1|Participant Flow|Control (Senfilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
678434|NCT01990664|O2|Outcome|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
678435|NCT01990664|O1|Outcome|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
678436|NCT01990664|E2|Reported Event|Test (Senofilcon A)|Subjects that were randomized to receive the Test lens for the duration of the study.
678437|NCT01990664|E1|Reported Event|Control (Senofilcon A)|Subjects that were randomized to receive the Control lens for the duration of the study.
678438|NCT01990534|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678439|NCT01990534|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678440|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678441|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678442|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678443|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678444|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678559|NCT01989455|E5|Reported Event|Placebo|Single intravenous dose of placebo (normal saline solution).
679044|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
678445|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678446|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678447|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678448|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678449|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678450|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678451|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678452|NCT01990534|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678453|NCT01990534|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 3-week cycle, until there is evidence of disease progression or unacceptable toxicity occurs (Up to 16 cycles). The dose may be decreased or delayed or discontinued in participants who develop treatment-associated non-hematologic toxicity, hematologic toxicity or peripheral neuropathy to brentuximab vedotin.
678454|NCT01990339|B1|Baseline|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
678455|NCT01990339|P1|Participant Flow|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
678456|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
678457|NCT01990339|O1|Outcome|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
678458|NCT01990339|E1|Reported Event|Lansoprazole|Lansoprazole (Takepron), tablets, orally, once daily for up to 8 weeks. Reflux esophagitis: the usual adult dosage is 30 mg of lansoprazole. For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily. Nonerosive gastroesophageal reflux disease: the usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks.
678459|NCT01990261|B1|Baseline|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678460|NCT01990261|P1|Participant Flow|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678560|NCT01989455|E4|Reported Event|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678461|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678462|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678463|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678464|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678465|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678466|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678467|NCT01990261|O1|Outcome|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678468|NCT01990261|E1|Reported Event|Erlotinib|Participants diagnosed with locally advanced or metastatic non-small cell lung with known carcinoma epidermal growth factor receptor (EGFR) status received erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
678469|NCT01989689|B3|Baseline|Total|Total of all reporting groups
678470|NCT01989689|B2|Baseline|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678471|NCT01989689|B1|Baseline|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678472|NCT01989689|P2|Participant Flow|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678473|NCT01989689|P1|Participant Flow|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678474|NCT01989689|O2|Outcome|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678475|NCT01989689|O1|Outcome|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678476|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678477|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678478|NCT01989689|O2|Outcome|Placebo/ Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678479|NCT01989689|O1|Outcome|Etanercept/ Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678480|NCT01989689|E2|Reported Event|Placebo/Etanercept|"The subjects will receive placebo injections for 3 months then will be switched to etanercept therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678481|NCT01989689|E1|Reported Event|Etanercept/Placebo|"The subjects will receive subcutaneous etanercept therapy at 50mg twice weekly for 3 months then will be switched to placebo therapy for an additional 3 months.~Etanercept: Etanercept 50mg twice weekly~Placebo"
678482|NCT01989572|B7|Baseline|Total|Total of all reporting groups
678483|NCT01989572|B6|Baseline|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
678484|NCT01989572|B5|Baseline|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
678485|NCT01989572|B4|Baseline|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
678486|NCT01989572|B3|Baseline|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
678487|NCT01989572|B2|Baseline|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
678561|NCT01989455|E3|Reported Event|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
679045|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
678488|NCT01989572|B1|Baseline|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
678489|NCT01989572|P6|Participant Flow|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
678490|NCT01989572|P5|Participant Flow|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
678491|NCT01989572|P4|Participant Flow|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
678492|NCT01989572|P3|Participant Flow|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
678493|NCT01989572|P2|Participant Flow|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
678494|NCT01989572|P1|Participant Flow|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
678495|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
678496|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
678497|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
678498|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
678499|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
678500|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
678501|NCT01989572|O6|Outcome|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
678502|NCT01989572|O5|Outcome|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
678503|NCT01989572|O4|Outcome|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC~peptide placebo: Given SC"
678504|NCT01989572|O3|Outcome|Arm III (GM-CSF, Peptide Placebo)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide placebo: Given SC"
678505|NCT01989572|O2|Outcome|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC~GM-CSF placebo: Given SC"
678506|NCT01989572|O1|Outcome|Arm I (GM-CSF, Peptide Vaccine)|"Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC~peptide vaccine: Given SC"
678507|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
678508|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
678509|NCT01989572|O2|Outcome|Peptide Placebo|Patients who were HLA-A2 positive and received peptide placebo in the trial, including 109 patients on arms III and 107 patients on arm IV
678510|NCT01989572|O1|Outcome|Peptide Vaccination|Patients who were HLA-A2 positive and received peptide vaccine in the trial, including 109 patients on arm I and 111 patients on arm II.
678511|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
678512|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
678513|NCT01989572|O2|Outcome|GM-CSF Placebo|Patients who did not receive GM-CSF (ie, received GM-CSF placebo) in the trial, including patients on arms II, IV and VI
678514|NCT01989572|O1|Outcome|GM-CSF|Patients received GM-CSF in the trial, including patients on arms I, III, V.
678515|NCT01989572|E6|Reported Event|Arm VI (GM-CSF Placebo)|"Patients receive GM-CSF (sargramostim) placebo SC on days 1-14.~GM-CSF placebo: Given SC"
678516|NCT01989572|E5|Reported Event|Arm V (GM-CSF)|"Patients receive GM-CSF (sargramostim) SC on days 1-14.~sargramostim: Given SC"
678562|NCT01989455|E2|Reported Event|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678517|NCT01989572|E4|Reported Event|Arm IV (GM-CSF Placebo, Peptide Placebo)|"Arm IV (GM-CSF placebo, peptide placebo) Patients receive GM-CSF placebo SC on days 1-14 and peptide placebo on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~GM-CSF placebo: Given SC peptide placebo: Given SC"
678518|NCT01989572|E3|Reported Event|Arm III (GM-CSF, Peptide Placebo)|"Arm III (GM-CSF, peptide placebo) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide placebo mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide placebo: Given SC"
678519|NCT01989572|E2|Reported Event|Arm II (GM-CSF Placebo, Peptide Vaccine)|"Arm II (GM-CSF placebo, peptide vaccine) Patients receive GM-CSF (sargramostim) placebo SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~peptide vaccine: Given SC GM-CSF placebo: Given SC"
678520|NCT01989572|E1|Reported Event|Arm I (GM-CSF, Peptide Vaccine)|"Arm I (GM-CSF, peptide vaccine) Patients receive GM-CSF (sargramostim) SC on days 1-14 and peptide vaccine comprising tyrosinase, gp100 antigen, and MART-1 antigen mixed with either incomplete Freund's adjuvant or Montanide ISA-51 VG SC on days 1 and 15 (course 1) and day 1 (course 2 and subsequent courses).~sargramostim: Given SC peptide vaccine: Given SC"
678521|NCT01989455|B6|Baseline|Total|Total of all reporting groups
678522|NCT01989455|B5|Baseline|Placebo|Single intravenous dose of placebo (normal saline solution).
678523|NCT01989455|B4|Baseline|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678524|NCT01989455|B3|Baseline|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678525|NCT01989455|B2|Baseline|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678526|NCT01989455|B1|Baseline|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678527|NCT01989455|P5|Participant Flow|Placebo|Single intravenous dose of placebo (normal saline solution).
678528|NCT01989455|P4|Participant Flow|2000 mg Deferiprone|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678529|NCT01989455|P3|Participant Flow|1500 mg Deferiprone|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678530|NCT01989455|P2|Participant Flow|1000 mg Deferiprone|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL), followed one week later by a single oral dose of 1000 mg deferiprone oral solution, 80 mg/mL
678531|NCT01989455|P1|Participant Flow|500 mg Deferiprone|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678532|NCT01989455|O1|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
678533|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
678534|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678535|NCT01989455|O2|Outcome|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
678536|NCT01989455|O1|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678537|NCT01989455|O5|Outcome|Placebo|Single intravenous dose of placebo (normal saline solution).
678538|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678539|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678540|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678541|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678542|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678543|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678544|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678545|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678546|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678547|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678548|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678549|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678550|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678551|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678552|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678553|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678554|NCT01989455|O4|Outcome|2000 mg Deferiprone for Infusion|Single intravenous dose of 2000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678555|NCT01989455|O3|Outcome|1500 mg Deferiprone for Infusion|Single intravenous dose of 1500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678556|NCT01989455|O2|Outcome|1000 mg Deferiprone for Infusion|Single intravenous dose of 1000 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678557|NCT01989455|O1|Outcome|500 mg Deferiprone for Infusion|Single intravenous dose of 500 mg deferiprone (deferiprone for infusion, 10 mg/mL)
678558|NCT01989455|E6|Reported Event|1000 mg Oral Deferiprone|Single oral dose of 1000 mg deferiprone (deferiprone oral solution, 80 mg/mL)
678564|NCT01988415|B1|Baseline|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
678565|NCT01988415|P1|Participant Flow|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available software used to calculate the LASIK treatment profile in one eye (active comparator [i.e., control]) and investigational software (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration) in the fellow eye (experimental).
678566|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
678567|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
678568|NCT01988415|O2|Outcome|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
678569|NCT01988415|O1|Outcome|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
678570|NCT01988415|E2|Reported Event|VSS-Rx1 OPM Treatment Planning Software|Investigational treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the VSS-Rx1 OPM treatment planning software
678571|NCT01988415|E1|Reported Event|Commercial iDesign Treatment Planning Software|Commercial iDesign treatment planning software: perform wavefront-guided LASIK based upon measurements obtained with the iDesign System and the commercial iDesign treatment planning software
678572|NCT01988402|B3|Baseline|Total|Total of all reporting groups
678573|NCT01988402|B2|Baseline|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
678574|NCT01988402|B1|Baseline|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
678575|NCT01988402|P2|Participant Flow|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
678576|NCT01988402|P1|Participant Flow|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
678577|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
678578|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
678579|NCT01988402|O2|Outcome|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
678580|NCT01988402|O1|Outcome|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
678581|NCT01988402|E2|Reported Event|Sugar Pill (Placebo)|"Patients in this arm receive one placebo (sugar) pill per day for 14 days then 2 placebo pills for 14 days.~Placebo (sugar pill)"
678582|NCT01988402|E1|Reported Event|Allopurinol|"Patients in this arm receive allopurinol, 100 mg daily for 14 days and then 200 mg daily for 14 days~allopurinol"
678583|NCT01989195|B1|Baseline|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
678584|NCT01989195|P1|Participant Flow|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
678585|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
678586|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI~Outcome measurement followed for both as all subjects received both MEMRI and DEMRI."
678587|NCT01989195|O1|Outcome|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
678588|NCT01989195|O2|Outcome|INVESTIGATIONAL MANGANESE-ENHANCED MRI (MEMRI)|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~MEMRI- SeeMore~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MR"
678630|NCT01989130|B2|Baseline|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
679054|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
678589|NCT01989195|O1|Outcome|DEMRI CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~DEMRI - MAGNEVIST (GADOLINIUM)~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
678590|NCT01989195|E1|Reported Event|CORONARY DISEASE SUBJECT|"ALL SUBJECTS IN THIS STUDY HAVE PREVIOUSLY DOCUMENTED CORONARY ARTERY DISEASE BY ANGIOGRAPHY~‘SEEMORE’ - MANGANESE-ENHANCED MRI CONTRAST REAGENT: EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH CLINICAL MAGNEVIST (GADOLINIUM), ONE WITH EXPERIMENTAL SEEMORE (MANGANESE) REAGENT. ADVERSE EVENTS TRACKED FOR SEEMORE MRI.~- CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
678591|NCT01989169|B3|Baseline|Total|Total of all reporting groups
678592|NCT01989169|B2|Baseline|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
678593|NCT01989169|B1|Baseline|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
678594|NCT01989169|P2|Participant Flow|Midazolam + SSP-004184SS First|Subjects received Midazolam 6mg and SSP-004184SS 30mg/kg in Period 1, followed by Midazolam 6mg during Period 2.
678595|NCT01989169|P1|Participant Flow|Midazolam First|Subjects received Midazolam 6mg in Period 1, followed by Midazolam 6mg and SSP-004184SS 30mg/kg during Period 2.
678596|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
678597|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
678598|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
678599|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
678600|NCT01989169|O2|Outcome|SSP-004184SS + Midazolam|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1.
678601|NCT01989169|O1|Outcome|Midazolam|Administered as a single oral 6 mg dose on Day 1.
678602|NCT01989169|E2|Reported Event|Midazolam + SSP-004184SS|Midazolam (6 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
678603|NCT01989169|E1|Reported Event|Midazolam Alone|Administered as a single oral 20 mg dose on Day 1.
678604|NCT01989156|B4|Baseline|Total|Total of all reporting groups
678605|NCT01989156|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678606|NCT01989156|B2|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678607|NCT01989156|B1|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678608|NCT01989156|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678609|NCT01989156|P2|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678610|NCT01989156|P1|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678611|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678612|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678613|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678614|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678615|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678616|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678617|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678618|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678619|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678620|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678621|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678622|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678623|NCT01989156|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678624|NCT01989156|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678625|NCT01989156|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678626|NCT01989156|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678627|NCT01989156|E2|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678628|NCT01989156|E1|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 86 Days in an Ambulatory Setting
678629|NCT01989130|B3|Baseline|Total|Total of all reporting groups
678631|NCT01989130|B1|Baseline|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
678632|NCT01989130|P2|Participant Flow|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
678633|NCT01989130|P1|Participant Flow|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
678634|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
678635|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
678636|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
678637|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
678638|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
678639|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
678640|NCT01989130|O2|Outcome|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
678641|NCT01989130|O1|Outcome|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
678642|NCT01989130|E2|Reported Event|Batched Results With Roche AMPLICOR CT/NG Test|"Diagnosis of +/- CT/NG within 1 to 4 days of visit to the ED~Roche AMPLICOR CT/NG"
678643|NCT01989130|E1|Reported Event|Real-time Results With Cepheid Xpert CT/NG Test|"Diagnosis of +/- CT/NG within 2 hours of specimen entering laboratory~Cepheid Xpert CT/NG Test"
678644|NCT01988857|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
678645|NCT01988857|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
678646|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
678647|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
678648|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
678649|NCT01988857|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
678650|NCT01988857|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix vaccine at 6-10 years of age.
678651|NCT01988662|B3|Baseline|Total|Total of all reporting groups
678652|NCT01988662|B2|Baseline|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678653|NCT01988662|B1|Baseline|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678654|NCT01988662|P2|Participant Flow|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678655|NCT01988662|P1|Participant Flow|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678656|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678657|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678658|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678659|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678660|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678661|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678662|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678663|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
679046|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
678664|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678665|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678666|NCT01988662|O2|Outcome|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678667|NCT01988662|O1|Outcome|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678668|NCT01988662|E3|Reported Event|Total|
678669|NCT01988662|E2|Reported Event|Aflibercept|101 patients with an eligible study eye were randomized to be treated with Aflibercept IVT. 2.0 mg of commercially available Aflibercept were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678670|NCT01988662|E1|Reported Event|Ranibizumab|104 patients with an eligible study eye were randomized to be treated with Ranibizumab IVT. 0.5 mg of commercially available Ranibizumab were used for intravitreal injection administered by an unblinded injecting physician. 3 injections were performed (Baseline, Month 1, Month 2).
678671|NCT01988129|B3|Baseline|Total|Total of all reporting groups
678672|NCT01988129|B2|Baseline|Control|Current practice
678673|NCT01988129|B1|Baseline|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678674|NCT01988129|P2|Participant Flow|Control|"Current practice.~Current practice. Firefighters in the Control Stations continued their normal role and were not invited to attend the sleep education and sleep disorders screening program. There was no formal contact with the control group.~As part of normal operational requirements, a small number of firefighters are reassigned to other stations each day and therefore 18/588 firefighters from control stations happened to be reassigned to an intervention station on the day of the education session and attended the session."
678675|NCT01988129|P1|Participant Flow|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening.~32 stations were paired according to workload. One from each pair was randomized to receive the intervention program. Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related hazards and discussed the importance of sleep, and included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678676|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
678677|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678678|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
678679|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678680|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
679047|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
678681|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678682|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
678683|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678684|NCT01988129|O1|Outcome|Baseline (Intervention)|Firefighters in the intervention group who volunteered to complete the sleep disorders screening survey
678685|NCT01988129|O2|Outcome|Control|Current practice
678686|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678687|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
678688|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678689|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
678690|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678691|NCT01988129|O2|Outcome|Intervention - Post-study Follow-up|Firefighters who completed the voluntary sleep disorders screening survey at the start of the study were invited to complete a subset of questions at the end of the 12-month study.
678692|NCT01988129|O1|Outcome|Intervention - Study Start|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678693|NCT01988129|O2|Outcome|Control|Current practice
678708|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678694|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678695|NCT01988129|O2|Outcome|Control|Current practice
678696|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678697|NCT01988129|O2|Outcome|Control|Current practice
678698|NCT01988129|O1|Outcome|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up."
678699|NCT01988129|E2|Reported Event|Control|A total of 15/588 firefighters in the control stations who were temporarily assigned to duty in the intervention stations on the day of the survey completed the screening survey. The remaining 573 firefighters did not complete the survey and therefore there are no adverse event data to report.
678700|NCT01988129|E1|Reported Event|Intervention|"Workplace-based fatigue risk management program consisting of sleep health education and sleep disorders screening~Sleep disorders education and screening: Firefighters were instructed to attend an education presentation which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, including strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey which used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. Those who screened positive for any sleep disorder were notified as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up. Of the 431 firefighters completed the sleep disorders screening survey, 416 were from the intervention stations."
678701|NCT01988012|B1|Baseline|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678702|NCT01988012|P1|Participant Flow|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 milligram (mg) tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678703|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678704|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678705|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678706|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678707|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
679048|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
678709|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678710|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678711|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678712|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678713|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678714|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678715|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678716|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678717|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678718|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678719|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678720|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678721|NCT01988012|O1|Outcome|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678722|NCT01988012|E1|Reported Event|Tocilizumab|Adults with rheumatoid arthritis were treated with 162 mg tocilizumab administered subcutaneously once weekly for 24 weeks. The protocol recommended suspending the treatment after week 24 for a period of 8 weeks, according to investigators’ discretion, for the purpose of drug-free immunogenicity testing. In the present study, none of the participants had their tocilizumab treatment suspended.
678723|NCT01987960|B3|Baseline|Total|Total of all reporting groups
678724|NCT01987960|B2|Baseline|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
678725|NCT01987960|B1|Baseline|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
678726|NCT01987960|P4|Participant Flow|Period 3 Placebo and PAR/SER|"Continuation of treatment with placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) from Period 1.~Placebo: Once daily, tablets, orally"
678755|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
679049|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
678727|NCT01987960|P3|Participant Flow|Period 2 Brexpiprazole and PAR/SER (Randomized Period)|"Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
678728|NCT01987960|P2|Participant Flow|Period 2 Placebo and PAR/SER (Randomized Period)|"Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
678729|NCT01987960|P1|Participant Flow|Period 1 Placebo and PAR/SER|"Placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER).~Placebo: Once daily, tablets, orally"
678730|NCT01987960|O4|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day. Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24)."
678731|NCT01987960|O3|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER) Placebo: Once daily, tablets, orally Absolute values at Week 12 in Period 2 (Study Week 24); randomized period.
678732|NCT01987960|O2|Outcome|Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
678733|NCT01987960|O1|Outcome|Period 2 Absolute Mean at Baseline; Placebo and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
678734|NCT01987960|O4|Outcome|Period 2 Absolute Mean at Week 12; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally~Absolute values at Week 12 in Period 2 (Study Week 24)"
678735|NCT01987960|O3|Outcome|Period 2 Absolute Mean at Week 12; Placebo and PAR/SER|"Period 2 absolute mean value at Week 12; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally~Absolute values at Week 12 in Period 2 (Study Week 24)"
678736|NCT01987960|O2|Outcome|Period 2 Absolute Mean at Baseline; Brexpiprazole and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized brexpiprazole adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER). Brexpiprazole dosing was 1mg/day for one week, followed by 2mg/day for 3 weeks. Thereafter the dose was flexible and could be adjusted from 1 to 3 mg/day; randomized period.~Brexpiprazole: 1 to 3 mg/day, once daily dose, tablets, orally"
678737|NCT01987960|O1|Outcome|Period 2 Absolute Mean at Baseline; Placebo and PAR/SER|"Period 2 absolute mean value at Baseline; Randomized placebo adjunct to open-label treatment with a commercially available approved treatment for PTSD (PAR/SER); randomized period.~Placebo: Once daily, tablets, orally"
678738|NCT01987960|E2|Reported Event|Placebo + PAR/SER (Randomized Period)|
678739|NCT01987960|E1|Reported Event|Brexpiprazole + PAR/SER (Randomized Period)|
678740|NCT01987908|B1|Baseline|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
678741|NCT01987908|P3|Participant Flow|Treatment With Placebo|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days during the double-blind treatment period
678742|NCT01987908|P2|Participant Flow|Treatment With Study Product|After placebo lead-in period, participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days during the double-blind treatment period
678743|NCT01987908|P1|Participant Flow|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
678744|NCT01987908|O1|Outcome|Overall Study Arm|
678745|NCT01987908|O1|Outcome|Overall Study Arm|
678746|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678747|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678748|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678749|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678750|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678751|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678752|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678753|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678754|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678833|NCT01987583|B3|Baseline|Total|Total of all reporting groups
719082|NCT01743963|B3|Baseline|Total|Total of all reporting groups
678756|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678757|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678758|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678759|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678760|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678761|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678762|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678763|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678764|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678765|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678766|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678767|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678768|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678769|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678770|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678771|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678772|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678773|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678774|NCT01987908|O1|Outcome|Overall Study Arm|
678775|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678776|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678777|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (placebo) was received
678778|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678779|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678780|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678781|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678782|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678783|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678784|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678785|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678786|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678787|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678788|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678789|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678790|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678791|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678792|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678793|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678948|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
678794|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678795|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678796|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678797|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678798|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678799|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678800|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678801|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678802|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678803|NCT01987908|O1|Outcome|Overall Study Arm|Data not collected
678804|NCT01987908|O4|Outcome|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
678805|NCT01987908|O3|Outcome|Double-blind Treatment Period - Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of placebo for 28 days (Day 1 to Day 28)
678806|NCT01987908|O2|Outcome|Double-blind Treatment Period - Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days (Day 1 to Day 28)
678807|NCT01987908|O1|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
678808|NCT01987908|O5|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
678809|NCT01987908|O4|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678810|NCT01987908|O3|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678811|NCT01987908|O2|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678812|NCT01987908|O1|Outcome|Placebo Lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
678813|NCT01987908|O3|Outcome|All Participants in Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received
678814|NCT01987908|O2|Outcome|Post-treatment With Placebo Observation Period|Participants underwent a post-treatment observation period of 21 days during which no placebo was received
678815|NCT01987908|O1|Outcome|Post-treatment With Study Product Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) was received
678816|NCT01987908|O1|Outcome|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo
678817|NCT01987908|O3|Outcome|All Treated Participants|All participants randomized 3:1 (Aes-103 to placebo) and received 4 times daily dosing of 1,000 mg AEs-103 or 1,000 mg of placebo for 28 days
678818|NCT01987908|O2|Outcome|Treatment With Placebo|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of placebo for 28 days
678819|NCT01987908|O1|Outcome|Treatment With Study Product|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of 1,000 mg of Aes-103 for 28 days
678820|NCT01987908|E3|Reported Event|Post-treatment Observation Period|Participants underwent a post-treatment observation period of 21 days during which no study product (Aes-103) or placebo was received (Day 29 to Day 49)
678821|NCT01987908|E2|Reported Event|Double-blind Treatment Period|Participants randomized 3:1 (Aes-103 to placebo) to receive 4 times daily dosing of either 1,000 mg of Aes-103 (study product) or placebo for 28 days (Day 1 to Day 28)
678822|NCT01987908|E1|Reported Event|Placebo lead-in Period|Participants enrolled in a 14 day single-blind placebo lead-in received 4 times daily dosing of placebo (Day -14 to Day -1)
678823|NCT01987765|B1|Baseline|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
678824|NCT01987765|P1|Participant Flow|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
678825|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
678826|NCT01987765|O1|Outcome|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
678827|NCT01987765|E1|Reported Event|Relestat Ophthalmic Solution 0.05%|Patients who are prescribed Relestat Ophthalmic Solution 0.05% as local standard of care in clinical practice.
678828|NCT01987752|B1|Baseline|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
678829|NCT01987752|P1|Participant Flow|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
678830|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
678831|NCT01987752|O1|Outcome|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
678832|NCT01987752|E1|Reported Event|Combigan® Ophthalmic Solution|Patients treated with Combigan® Ophthalmic Solution as per local standard of care in clinical practice.
678834|NCT01987583|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678835|NCT01987583|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678836|NCT01987583|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678837|NCT01987583|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678838|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678839|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678840|NCT01987583|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678841|NCT01987583|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678842|NCT01987583|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678843|NCT01987583|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions every other day, on the 17th, 19th and 21st days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
678844|NCT01987557|B4|Baseline|Total|Total of all reporting groups
678845|NCT01987557|B3|Baseline|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
678846|NCT01987557|B2|Baseline|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
678847|NCT01987557|B1|Baseline|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
678848|NCT01987557|P3|Participant Flow|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
678849|NCT01987557|P2|Participant Flow|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
678850|NCT01987557|P1|Participant Flow|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
678851|NCT01987557|O3|Outcome|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
678852|NCT01987557|O2|Outcome|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
678853|NCT01987557|O1|Outcome|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
678854|NCT01987557|E3|Reported Event|Regular Treadmill Walking|"participants will walk at a comfortable self-selected pace on a treadmill~regular treadmill walking"
678855|NCT01987557|E2|Reported Event|Magnitude Treadmill Group|"In this condition participants will walk on a treadmill with weights on their ankles to elicit a greater magnitude of instrinsic feedback from force sensitive golgi tendon organs~magnitude treadmill group"
678856|NCT01987557|E1|Reported Event|Treadmill Intervention 1: Rate Group|"Participants in this condition will walk with a cadence (steps per minute) that is approximately 35% faster than comfortable walking pace. In this condition, participants will maintain a step length that is similar to that of their comfortable walking pace.~rate group: walking with a high cadence (steps per minute)"
678857|NCT01987453|B4|Baseline|Total|Total of all reporting groups
678858|NCT01987453|B3|Baseline|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678859|NCT01987453|B2|Baseline|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678860|NCT01987453|B1|Baseline|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678861|NCT01987453|P3|Participant Flow|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678862|NCT01987453|P2|Participant Flow|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678863|NCT01987453|P1|Participant Flow|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior sofosbuvir (SOF) + ribavirin (RBV) ± pegylated interferon (Peg-IFN) regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678864|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678865|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678866|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678867|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678868|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678869|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678870|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678871|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678872|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
679050|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
678873|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678874|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678875|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678876|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF + RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678877|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678878|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678879|NCT01987453|O3|Outcome|LDV/SOF + RBV 24 Weeks (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678880|NCT01987453|O2|Outcome|LDV/SOF 24 Weeks (Group 2)|Participants who failed a prior LDV/SOF ± RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678881|NCT01987453|O1|Outcome|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678882|NCT01987453|E3|Reported Event|LDV/SOF + RBV 24 Week (Group 3)|Participants with advanced compensated or decompensated cirrhosis who failed a prior SOF+RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily + RBV (adjusted for hemoglobin and renal status) for 24 weeks
678883|NCT01987453|E2|Reported Event|LDV/SOF 24 Week (Group 2)|Participants who failed a prior LDV/SOF±RBV regimen received LDV/SOF FDC (90/400 mg) tablet administered orally once daily for 24 weeks
678884|NCT01987453|E1|Reported Event|LDV/SOF + RBV 12 Weeks (Group 1)|Participants who failed a prior SOF+RBV ± Peg-IFN regimen received LDV/SOF (90/400 mg) FDC tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
678885|NCT01987349|B9|Baseline|Total|Total of all reporting groups
678886|NCT01987349|B8|Baseline|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
678887|NCT01987349|B7|Baseline|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
678888|NCT01987349|B6|Baseline|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
678889|NCT01987349|B5|Baseline|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
678890|NCT01987349|B4|Baseline|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
678891|NCT01987349|B3|Baseline|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
678892|NCT01987349|B2|Baseline|Group A: Age 8-17 yo Identical Twins (FluMist)|Participants will be randomized to receive FluMist® (intranasal)
678893|NCT01987349|B1|Baseline|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
678894|NCT01987349|P8|Participant Flow|Group G: 70-100 yo Nontwins|Participants to receive Fluzone® (intramuscular)
678895|NCT01987349|P7|Participant Flow|Group F: 70-100 yo Identical Twins|Participants to receive Fluzone® (intramuscular)
678896|NCT01987349|P6|Participant Flow|Group E: Age 40-49 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
678897|NCT01987349|P5|Participant Flow|Group D: Age 40-49 yo Identical Twins|Participants to receive FluMist® (intranasal)
678898|NCT01987349|P4|Participant Flow|Group C: Age 18-30 yo Fraternal Twins|Participants to receive FluMist® (intranasal)
678899|NCT01987349|P3|Participant Flow|Group B: Age 18-30 yo Identical Twins|Participants to receive FluMist® (intranasal)
678900|NCT01987349|P2|Participant Flow|Group A: Age 8-17yo Identical Twins|Participants will be randomized to receive FluMist® (intranasal)
678901|NCT01987349|P1|Participant Flow|Group A: Age 8-17 yo Identical Twins|Participants will be randomized to receive Fluzone® (intramuscular)
678902|NCT01987349|O8|Outcome|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
678903|NCT01987349|O7|Outcome|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
678904|NCT01987349|O6|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678905|NCT01987349|O5|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678906|NCT01987349|O4|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678907|NCT01987349|O3|Outcome|Group B: 18-30 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678908|NCT01987349|O2|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678909|NCT01987349|O1|Outcome|Group A: Age 8-17 yo Identical Twins (IM)|"Participants will be randomized to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
679051|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
678910|NCT01987349|O8|Outcome|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
678911|NCT01987349|O7|Outcome|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
678912|NCT01987349|O6|Outcome|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678913|NCT01987349|O5|Outcome|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678914|NCT01987349|O4|Outcome|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678915|NCT01987349|O3|Outcome|Group B: 18-30 yo Identical Twins|"Participants to receive FluMist® (intranasal)~FluMist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678916|NCT01987349|O2|Outcome|Group A: Age 8-17 yo Identical Twins (IN)|"Participants will be randomized to receive FluMist® (intranasal~FluMist®: Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678917|NCT01987349|O1|Outcome|Group A: Age 8-17 yo Identical Twins (IM)|"Participants will be randomized to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
678918|NCT01987349|E8|Reported Event|Group G: 70-100 yo Non-twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
678919|NCT01987349|E7|Reported Event|Group F: 70-100 yo Twins|"Participants to receive Fluzone® (intramuscular)~Fluzone® (intramuscular): Licensed seasonal trivalent inactivated influenza vaccine (IIV3)"
678920|NCT01987349|E6|Reported Event|Group E: 40-49 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678921|NCT01987349|E5|Reported Event|Group D: 40-49 yo Identical Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678922|NCT01987349|E4|Reported Event|Group C: 18-30 yo Fraternal Twins|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678923|NCT01987349|E3|Reported Event|Group B: 18-30 yo Identical Twin Pairs|"Participants to receive Flumist® (intranasal)~Flumist® (intranasal): Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)"
678924|NCT01987349|E2|Reported Event|Group A: Age 8-17 yo Identical Twins (Flumist)|Participants will be randomized to receive Flumist® (intranasal)
678925|NCT01987349|E1|Reported Event|Group A: Age 8-17 yo Identical Twins (Fluzone)|Participants will be randomized to receive Fluzone® (intramuscular)
678926|NCT01987219|B7|Baseline|Total|Total of all reporting groups
678927|NCT01987219|B6|Baseline|Ipratropium; Placebo; Albuterol|
678928|NCT01987219|B5|Baseline|Placebo; Albuterol; Ipratropium|
678929|NCT01987219|B4|Baseline|Placebo; Ipratropium; Albuterol|
678930|NCT01987219|B3|Baseline|Albuterol; Ipratropium; Placebo|
678931|NCT01987219|B2|Baseline|Albuterol; Placebo; Ipratropium|
678932|NCT01987219|B1|Baseline|Ipratropium; Alubterol; Placebo|
678933|NCT01987219|P6|Participant Flow|Ipratropium; Placebo; Albuterol|Participants in this group received ipratropium followed by placebo followed by albuterol
678934|NCT01987219|P5|Participant Flow|Placebo; Albuterol; Ipratropium|Participants in this group received placebo followed by albuterol followed by ipratropium
678935|NCT01987219|P4|Participant Flow|Placebo; Ipratropium; Albuterol|Participants in this group received placebo followed by ipratropium followed by albuterol
678936|NCT01987219|P3|Participant Flow|Albuterol; Ipratropium; Placebo|Participants in this group received albuterol followed by ipratropium followed by placebo
678937|NCT01987219|P2|Participant Flow|Albuterol; Placebo; Ipratropium|Participants in this group received albuterol followed by placebo followed by ipratropium
678938|NCT01987219|P1|Participant Flow|Ipratropium; Alubterol; Placebo|Participants in this group received ipratropium followed by albuterol followed by placebo
678939|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
678940|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
678941|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
678942|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
678943|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
678944|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
678945|NCT01987219|O3|Outcome|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
678946|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
678947|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
720686|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
678949|NCT01987219|O2|Outcome|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
678950|NCT01987219|O1|Outcome|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
678951|NCT01987219|E3|Reported Event|Placebo|"Placebo Saline solution 3 cc NA~placebo: Saline solution 3 cc NA"
678952|NCT01987219|E2|Reported Event|Ipratropium-bromide (Atrovent ®)|"IpratroAnti-cholinergic(Atrovent ®) 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours.pium-bromide~Ipratropium-bromide: Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 – 90 mins. Duration of effect 2 – 4 hours."
678953|NCT01987219|E1|Reported Event|Albuterol-sulphate|"Albuterol-sulphate (Proventil ®) Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours~Albuterol-sulphate: Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 – 30 mins. Mean duration of effect 3 hours"
678954|NCT01986985|B1|Baseline|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
678955|NCT01986985|P1|Participant Flow|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
678956|NCT01986985|O1|Outcome|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
678957|NCT01986985|E1|Reported Event|Single Arm PET MRI|"single group evaluation of PET/ MR for diagnostic quality of image~PET/MRI system: Compared to PET CT"
678958|NCT01986946|B3|Baseline|Total|Total of all reporting groups
678959|NCT01986946|B2|Baseline|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678960|NCT01986946|B1|Baseline|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
678961|NCT01986946|P2|Participant Flow|Epidural Catheter|"The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.~Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery."
678962|NCT01986946|P1|Participant Flow|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
678963|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678964|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678965|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678966|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678967|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678968|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678969|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678970|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678971|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678972|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678973|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678974|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678975|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678976|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678977|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678978|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678979|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678980|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678981|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678982|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678983|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678984|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678985|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678986|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678987|NCT01986946|O2|Outcome|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678988|NCT01986946|O1|Outcome|Intravenous Opioids|This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
678989|NCT01986946|E2|Reported Event|Epidural Catheter|Epidural Catheter - Dilaudid: Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
678990|NCT01986946|E1|Reported Event|Intravenous Opioids|"This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery. Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.~Dilaudid: Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid)."
678991|NCT01986790|B4|Baseline|Total|Total of all reporting groups
678992|NCT01986790|B3|Baseline|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
678993|NCT01986790|B2|Baseline|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
678994|NCT01986790|B1|Baseline|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
678995|NCT01986790|P3|Participant Flow|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
678996|NCT01986790|P2|Participant Flow|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
678997|NCT01986790|P1|Participant Flow|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
679052|NCT01986062|O1|Outcome|AR11 (Amphetamine Sulfate)|AR11, administered orally, BID, 10-40 mg/day
678998|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
678999|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
679000|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
679001|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
679002|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
679003|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
679004|NCT01986790|O3|Outcome|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
679005|NCT01986790|O2|Outcome|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
679006|NCT01986790|O1|Outcome|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
679007|NCT01986790|E3|Reported Event|Plain Language + Narratives|"This intervention group will receive the plain language table plus narratives about how others might use and rate the insurance plans.~Plain Language + Narratives"
679008|NCT01986790|E2|Reported Event|Plain Language + Visuals|"This intervention group will receive the plain-language table plus visuals that focus on specific features of the plans. Participants will be able to view the information about each health insurance feature one feature at a time, in the order they prefer.~Plain Language + Visuals"
679009|NCT01986790|E1|Reported Event|Plain Language|"This intervention group will receive a plain-language table describing the features and costs of health insurance plans, with definitions of health insurance terms incorporated into the table.~Plain Language"
679010|NCT01986751|B3|Baseline|Total|Total of all reporting groups
679011|NCT01986751|B2|Baseline|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
679012|NCT01986751|B1|Baseline|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
679013|NCT01986751|P2|Participant Flow|Ropivacaine|"Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine~ropivacaine"
679014|NCT01986751|P1|Participant Flow|Clonidine and Ropivacaine|"A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).~Clonidine~ropivacaine"
679015|NCT01986751|O2|Outcome|Ropivacaine|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679016|NCT01986751|O1|Outcome|Clonidine and Ropivacaine|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679017|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679018|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679019|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679020|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679021|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679022|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose). Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679023|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679042|NCT01986062|P1|Participant Flow|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID, for one week (crossover to placebo administration week 2)
679024|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679025|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679026|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679027|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679028|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679029|NCT01986751|O2|Outcome|Ropivacaine (Control)|A bolus of 20ml of 0.5% ropivacaine will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679030|NCT01986751|O1|Outcome|Clonidine and Ropivacaine (Study Group)|A bolus of 20ml of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).Standard saphenous nerve block (adductor canal approach) will be performed using 15ml of 0.5% ropivacaine.
679031|NCT01986751|E2|Reported Event|Ropivacaine (Control)|Standard saphenous nerve block (adductor canal approach) will be performed using 20 ml of 0.5% ropivacaine
679032|NCT01986751|E1|Reported Event|Clonidine and Ropivacaine (Study Group)|A bolus of 20 mL of 0.5% ropivacaine mixed with clonidine 1mcg/kg will be injected through the stimulating needle with gentle aspiration between divided doses (5 mL per dose).
679033|NCT01986231|B1|Baseline|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
679034|NCT01986231|P1|Participant Flow|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
679035|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
679036|NCT01986231|O1|Outcome|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
679037|NCT01986231|E1|Reported Event|Open-Label Glucagon|"Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.~Glucagon: Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35."
679038|NCT01986062|B3|Baseline|Total|Total of all reporting groups
679039|NCT01986062|B2|Baseline|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID for one week (crossover to AR11 administration week 2)
679040|NCT01986062|B1|Baseline|AR11 (1 Week) Then Placebo (1 Week) - Double Blind|AR11, administered orally, BID for one week (crossover to placebo administration week 2)
679041|NCT01986062|P2|Participant Flow|Placebo (1 Week) Then AR11 (1 Week) - Double Blind|Placebo, administered orally, BID, for one week (crossover to AR11administration week 2)
679043|NCT01986062|O2|Outcome|Placebo|Placebo, administered orally, BID
679058|NCT01985581|B2|Baseline|GXR First Then PLB|subjects received GXR in first arm of study and PLB in second arm subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
679059|NCT01985581|B1|Baseline|PLB First Then GXR|subjects received PLB in first arm of study and GXR in second arm. subject continued to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
679060|NCT01985581|P2|Participant Flow|GXR First Then Placebo|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and GXR for the first intervention period and placebo for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
679061|NCT01985581|P1|Participant Flow|Placebo First Then GXR|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and placebo for the first intervention period and GXR for the second intervention period (after a washout period). GXR dose was optimized to between 1 and 4mg.
679062|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR (optimized dose 1-4 mg)
679063|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
679064|NCT01985581|O2|Outcome|GXR and Stimulant|subjects who continued to take usual stimulant dosage and took GXR at optimized dose of 1-4 mg
679065|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects who continued to take usual stimulant dosage and took placebo
679066|NCT01985581|O2|Outcome|GXR and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and GXR (optimized dose 1-4 mg)
679067|NCT01985581|O1|Outcome|Placebo and Stimulant|The child's quality of life as assessed by the parent was measured in subjects taking usual stimulant and placebo
679068|NCT01985581|O2|Outcome|Stimulant and Guanfancine Extended Release|"patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine) and also receive guanfacine extended release at a individually optimized dosage of 1-4 mg.~Guanfacine extended release"
679069|NCT01985581|O1|Outcome|Stimulant & Placebo|"patient will continue to take stable dosage of usual stimulant(Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)therapy plus placebo~Placebo"
679070|NCT01985581|O2|Outcome|GXR and Stimulant|Patients continued to take usual dose stimulant and optimized dose (1-4mg) of GXR
679071|NCT01985581|O1|Outcome|Placebo and Stimulant|subjects continued to take usual dose stimulant and took placebo
679072|NCT01985581|O2|Outcome|GXR and Stimulant|The quality of life was measured in those patients taking GXR along with their usual stimulant therapy
679073|NCT01985581|O1|Outcome|Placebo and Stimulant|The quality of life was measured in those patients taking placebo along with their usual stimulant therapy
679074|NCT01985581|O2|Outcome|GXR and Stimulant|Subjects received GXR (1-4 mg as optimized dosage) in addition to usual stimulant therapy
679075|NCT01985581|O1|Outcome|Placebo and Stimulant|Subjects received placebo and usual stimulant therapy
679076|NCT01985581|E2|Reported Event|Stimulant and PLB|adverse event frequency in those taking stimulant + PLB
679077|NCT01985581|E1|Reported Event|Stimulant and GXR|adverse event frequency in those taking stimulant + GXR
679078|NCT01985425|B3|Baseline|Total|Total of all reporting groups
679079|NCT01985425|B2|Baseline|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679080|NCT01985425|B1|Baseline|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679081|NCT01985425|P2|Participant Flow|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679082|NCT01985425|P1|Participant Flow|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679083|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679084|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679085|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679114|NCT01985126|P1|Participant Flow|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679086|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
727957|NCT01704287|B4|Baseline|Total|Total of all reporting groups
679087|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679088|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679089|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679090|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679091|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679092|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679093|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679094|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679095|NCT01985425|O2|Outcome|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679096|NCT01985425|O1|Outcome|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679097|NCT01985425|E2|Reported Event|Placebo Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine placebo 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine Placebo"
679098|NCT01985425|E1|Reported Event|Active Colchicine|"On the day of surgery, the intervention group will receive 2 doses of colchicine 0.6 mg orally. The first dose will be administered within 4 hours before surgery. The second dose will be given between 6:00PM and 11:59PM after surgery. All patients will receive colchicine 0.6 mg or placebo twice daily orally for 10 days.~Colchicine"
679099|NCT01985321|B3|Baseline|Total|Total of all reporting groups
679100|NCT01985321|B2|Baseline|Ethanol|36 applications over a 96 hour period
679101|NCT01985321|B1|Baseline|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
679102|NCT01985321|P2|Participant Flow|Ethanol|36 applications over a 96 hour period
679103|NCT01985321|P1|Participant Flow|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
679104|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
679105|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
679106|NCT01985321|O2|Outcome|Ethanol|36 applications over a 96 hour period
679107|NCT01985321|O1|Outcome|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
679108|NCT01985321|E2|Reported Event|Ethanol|36 applications over a 96 hour period
679109|NCT01985321|E1|Reported Event|Merlin - Ethanol/Glycolic Acid Solution|"36 applications over a 96 hour period~ethanol/glycolic acid solution: ethanol/glycolic acid solution"
679110|NCT01985126|B3|Baseline|Total|Total of all reporting groups
679111|NCT01985126|B2|Baseline|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679112|NCT01985126|B1|Baseline|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679113|NCT01985126|P2|Participant Flow|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679115|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679480|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679116|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679117|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679118|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679119|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679120|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679121|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679122|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679123|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679124|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679125|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679126|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679127|NCT01985126|O2|Outcome|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679128|NCT01985126|O1|Outcome|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679129|NCT01985126|E2|Reported Event|Daratumumab 16 mg/kg|Daratumumab 16 mg/kg weekly for 8 week; then every 2 week for 16 week; then every 4 week in Part 1 and Part 2 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679130|NCT01985126|E1|Reported Event|Daratumumab 8 Milligram Per Kilogram (mg/kg)|Daratumumab 8 mg/kg every 4 week in Part 1 until disease progression, unacceptable toxicity, discontinuation due to AE or death (from any cause).
679131|NCT01984697|B6|Baseline|Total|Total of all reporting groups
679132|NCT01984697|B5|Baseline|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679133|NCT01984697|B4|Baseline|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679134|NCT01984697|B3|Baseline|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679135|NCT01984697|B2|Baseline|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679136|NCT01984697|B1|Baseline|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679137|NCT01984697|P5|Participant Flow|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679138|NCT01984697|P4|Participant Flow|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679139|NCT01984697|P3|Participant Flow|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679140|NCT01984697|P2|Participant Flow|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679141|NCT01984697|P1|Participant Flow|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679142|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679143|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679144|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679145|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679146|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679147|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679769|NCT01979133|O1|Outcome|Baseline|Baseline Mean Standard Drinks Per Week
679148|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679149|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679150|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679151|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679152|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679153|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679154|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679155|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679156|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679157|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679158|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679159|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679160|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679161|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679162|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679163|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679164|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679165|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679166|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679167|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679168|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679169|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679170|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679171|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679172|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679173|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679174|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679175|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679176|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679177|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679178|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679179|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679180|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679181|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679182|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679183|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679184|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679185|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679186|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679187|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679188|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679189|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679190|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679191|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679192|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679193|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679194|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679195|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679196|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679197|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679198|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679199|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679200|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679201|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679202|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679203|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679204|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679205|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679206|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679207|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679208|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679209|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679210|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679211|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679212|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679213|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679214|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679215|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679216|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679217|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679218|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679219|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679220|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679221|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679770|NCT01979133|O2|Outcome|Week 8|Week 8 QIDS Score
679222|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679223|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679224|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679225|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679226|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679227|NCT01984697|O5|Outcome|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young Women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679228|NCT01984697|O4|Outcome|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679229|NCT01984697|O3|Outcome|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679230|NCT01984697|O2|Outcome|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679231|NCT01984697|O1|Outcome|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679232|NCT01984697|E5|Reported Event|Young Women 16 to 26 Years V503 at Months 0, 2, and 6|Young women aged 16 to 26 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679233|NCT01984697|E4|Reported Event|Girls 9 to 14 Years V503 at Months 0, 2, and 6|Girls aged 9 to 14 years received a 3-dose regimen of V503 0.5 mL intramuscular injection at Months 0, 2, and 6
679234|NCT01984697|E3|Reported Event|Girls and Boys 9 to 14 Years V503 at Months 0 and 12|Girls and boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 12
679235|NCT01984697|E2|Reported Event|Boys 9 to 14 Years V503 at Months 0 and 6|Boys aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679236|NCT01984697|E1|Reported Event|Girls 9 to 14 Years V503 at Months 0 and 6|Girls aged 9 to 14 years received a 2-dose regimen of V503 0.5 mL intramuscular injection at Months 0 and 6
679237|NCT01984515|B1|Baseline|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
679238|NCT01984515|P1|Participant Flow|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
679239|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
679240|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
679241|NCT01984515|O1|Outcome|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
679305|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679439|NCT01982812|P1|Participant Flow|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
679242|NCT01984515|E1|Reported Event|Team Red Primary Care|"Eligible patients will receive the Referral Management System in primary care~Referral Management System: Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
679243|NCT01984294|B4|Baseline|Total|Total of all reporting groups
679244|NCT01984294|B3|Baseline|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679245|NCT01984294|B2|Baseline|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679246|NCT01984294|B1|Baseline|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
679247|NCT01984294|P3|Participant Flow|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679248|NCT01984294|P2|Participant Flow|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679249|NCT01984294|P1|Participant Flow|LDV/SOF+RBV|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
679250|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679251|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679252|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
679253|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679254|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679255|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
679256|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679257|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679258|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
679259|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679260|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679261|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
679262|NCT01984294|O3|Outcome|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679263|NCT01984294|O2|Outcome|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679264|NCT01984294|O1|Outcome|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) in a divided daily dose for 8 weeks
679265|NCT01984294|E3|Reported Event|LDV/SOF+GS-9669 500 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (2 x 250 mg) tablets once daily for 8 weeks
679266|NCT01984294|E2|Reported Event|LDV/SOF+GS-9669 250 mg|LDV/SOF 90/400 mg FDC tablet plus GS-9669 (1 x 250 mg) tablet once daily for 8 weeks
679267|NCT01984294|E1|Reported Event|LDV/SOF+RBV|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
679268|NCT01984229|B3|Baseline|Total|Total of all reporting groups
679269|NCT01984229|B2|Baseline|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
679270|NCT01984229|B1|Baseline|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
679271|NCT01984229|P2|Participant Flow|Cohort B:Alectinib 300mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 21). Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
679306|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679307|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679308|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679272|NCT01984229|P1|Participant Flow|Cohort A: Alectinib 40mg, Posaconazole, Alectinib+Posaconazole|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 14), and Period 3 (Days 15 to 18). Alectinib was administered as a 40 milligrams (mg) single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants). On Days 8 to 14 (Period 2) and Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg twice daily (BID) oral dose after a high-fat meal. The follow-up assessments occurred within 10 to 14 days after the last dose of posaconazole.
679273|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679274|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679275|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679276|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679277|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679278|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679279|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679280|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679281|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679282|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679283|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679284|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679285|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679286|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679287|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679288|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679289|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679290|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679291|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679292|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679293|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679294|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679295|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679296|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679297|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679298|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679299|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679300|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679301|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679302|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679303|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679304|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679677|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
679309|NCT01984229|O2|Outcome|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679310|NCT01984229|O1|Outcome|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679311|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679312|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679313|NCT01984229|O2|Outcome|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679314|NCT01984229|O1|Outcome|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679315|NCT01984229|E6|Reported Event|Cohort B: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 300-mg single oral dose on Day 15 (Period 3). On Days 15 to 21 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679316|NCT01984229|E5|Reported Event|Cohort B: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
679317|NCT01984229|E4|Reported Event|Cohort B: Alectinib (Period 1)|Alectinib was administered as a 300-mg single oral dose on Day 1 (Period 1).
679318|NCT01984229|E3|Reported Event|Cohort A: Alectinib + Posaconazole (Period 3)|Alectinib was administered as a 40-mg single oral dose on Day 15 (Period 3). On Days 15 to 18 (Period 3) posaconazole was administered as a 400-mg BID oral dose after a high-fat meal.
679319|NCT01984229|E2|Reported Event|Cohort A: Posaconazole (Period 2)|Posaconazole was administered as a 400-mg BID oral dose on Days 8 to 14 (Period 2) after a high-fat meal.
679320|NCT01984229|E1|Reported Event|Cohort A: Alectinib (Period 1)|Alectinib was administered as a 40-mg single oral dose on Day 1 (Period 1).
679321|NCT01983878|B1|Baseline|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679322|NCT01983878|P1|Participant Flow|Ramucirumab 8 mg/kg|Ramucirumab 8 milligrams per kilogram (mg/kg) administered intravenously (IV) once every 2 weeks. Treatment continued until there is evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679323|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679324|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679325|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679326|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679327|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679328|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679329|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679330|NCT01983878|O1|Outcome|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679331|NCT01983878|E1|Reported Event|Ramucirumab 8 mg/kg|Ramucirumab 8 mg/kg administered IV once every 2 weeks. Treatment continued until there is evidence of PD, the development of unacceptable toxicity, protocol non-compliance, or withdrawal of consent.
679332|NCT01983839|B1|Baseline|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
679333|NCT01983839|P1|Participant Flow|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
679334|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.~The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
679374|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679375|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679335|NCT01983839|O1|Outcome|Pharmacokinetics Moxifloxacin|"Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.~The model estimated median values of total Cmax and fAUC0-24 for the current study population were3.99 mg/L (IQR 3.19; 5.29) and 32.78 mg.hr/L (IQR 22.75; 47.31). respectively."
679336|NCT01983839|E1|Reported Event|Pharmacokinetics Moxifloxacin|Patients with diagnosed CAP who were prescribed moxifloxacin 400 mg qd (Avelox® 400 mg Bayer) empirically by the treating physician, according to national CAP treatment guideline, had plasma concentrations of moxifloxacin determined. Patients under 18 years of age were excluded from the study and the age, gender and body weight of each enrolled patient were registered.
679337|NCT01983787|B1|Baseline|Pharmacokinetics Piperacillin|Patients with cystic fibrosis and pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
679338|NCT01983787|P1|Participant Flow|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
679339|NCT01983787|O9|Outcome|Patient 10|MIC (mg/L) of pathogen detected in sputum: 2 mg/L
679340|NCT01983787|O8|Outcome|Patient 9|MIC (mg/L) of pathogen detected in sputum: 0.75 mg/L
679341|NCT01983787|O7|Outcome|Patient 8|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
679342|NCT01983787|O6|Outcome|Patient 7|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
679343|NCT01983787|O5|Outcome|Patient 6|MIC (mg/L) of pathogen detected in sputum: 0.5 mg/L
679344|NCT01983787|O4|Outcome|Patient 4|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
679345|NCT01983787|O3|Outcome|Patient 3|MIC (mg/L) of pathogen detected in sputum: 16 mg/L
679346|NCT01983787|O2|Outcome|Patient 2|MIC (mg/L) of pathogen detected in sputum: 8 mg/L
679347|NCT01983787|O1|Outcome|Patient 1|MIC (mg/L) of pathogen detected in sputum: 3 mg/L
679348|NCT01983787|O9|Outcome|T>MIC 12g/Day, Patient 10|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679349|NCT01983787|O8|Outcome|T>MIC 12g/Day, Patient 9|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Acromobacter. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679350|NCT01983787|O7|Outcome|T>MIC 12g/Day, Patient 8|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679351|NCT01983787|O6|Outcome|T>MIC 12g/Day, Patient 7|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679352|NCT01983787|O5|Outcome|T>MIC12g/Day, Patient 6|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679353|NCT01983787|O4|Outcome|T>MIC 16g/Day, Patient 4|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679354|NCT01983787|O3|Outcome|T>MIC 16g/Day, Patient 3|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679355|NCT01983787|O2|Outcome|T>MIC 16g/Day, Patient 2|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Pseudomonas aeruginosa. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679356|NCT01983787|O1|Outcome|T>MIC 16g/Day, Patient 1|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks. Pathogen in sputum: Staphylococcus aureus. If the piperacillin concentration at all measurements during the treatment period was at a level above the MIC, T>MIC is reported as 100%.
679357|NCT01983787|O2|Outcome|Pharmacokinetics Piperacillin 12g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 12 g/24 hours, given as continuous infusion for a period of two weeks.
679358|NCT01983787|O1|Outcome|Pharmacokinetics Piperacillin 16g/Day|Patients with cystic fibrosis , treated with Piperacillin/Tazobactam 16 g/24 hours, given as continuous infusion for a period of two weeks.
679359|NCT01983787|E1|Reported Event|Pharmacokinetics Piperacillin|Patients with cystic fibrosis with pulmonary exacerbation, treated with Piperacillin/Tazobactam, given as continuous infusion for a period of two weeks.
679360|NCT01983566|B5|Baseline|Total|Total of all reporting groups
679376|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679361|NCT01983566|B4|Baseline|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
679362|NCT01983566|B3|Baseline|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele fasted.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
679363|NCT01983566|B2|Baseline|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Dele after a standardised high-fat, high-calorie meal, followed by a washout phase, followed by Dele after a standardised low-fat meal, followed by a washout phase, followed by Dele fasted, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
679364|NCT01983566|B1|Baseline|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Dele fasted, followed by a washout phase, followed by Dele after a standardised high-fat, high- calorie meal, followed by a washout phase, followed by Dele after a 4 days pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase, followed by Dele after a standardised low-fat meal.~Each Dele intake is a single dose of 3x 200mg Dele film-coated tablets after an overnight fast of at least 10 h.~The duration of a washout phase was at least 6 days."
679365|NCT01983566|P4|Participant Flow|Dele + OMP / Dele Fasted / Dele Low Fat / Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
679366|NCT01983566|P3|Participant Flow|Dele Low Fat / Dele + OMP / Dele High Fat / Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
679367|NCT01983566|P2|Participant Flow|Dele High Fat / Dele Low Fat / Dele Fasted / Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg OMP gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
679368|NCT01983566|P1|Participant Flow|Dele Fasted / Dele High Fat / Dele + OMP / Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Deleobuvir (Dele) film-coated tablets after an overnight fast of at least 10 hours (h), followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily, followed by a washout phase of at least 6 days; then each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~All medications were administered oral with 240 mL of water."
679369|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
679370|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679371|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679372|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679373|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
679763|NCT01979133|O1|Outcome|Baseline|Baseline YMRS Score
679377|NCT01983566|O4|Outcome|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
679378|NCT01983566|O3|Outcome|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679379|NCT01983566|O2|Outcome|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679380|NCT01983566|O1|Outcome|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679381|NCT01983566|E5|Reported Event|OMP Alone|One gastro-resistant hard capsule of Omeprazole (OMP) (40 mg) once daily in the evening for 4 days administered oral with 240 mL of water.
679382|NCT01983566|E4|Reported Event|Dele + OMP|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h after 4 days of pre-treatment with a 40 mg Omeprazole (OMP) gastro-resistant hard capsule once daily.~All medications were administered oral with 240 mL of water."
679383|NCT01983566|E3|Reported Event|Dele Low Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised low-fat meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679384|NCT01983566|E2|Reported Event|Dele High Fat|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after a standardised high-fat, high-calorie meal after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679385|NCT01983566|E1|Reported Event|Dele Fasted|"Each subject received a single dose of 3 x 200 mg Dele film-coated tablets after an overnight fast of at least 10 h.~The tablets were administered oral with 240 mL of water."
679386|NCT01983254|B3|Baseline|Total|Total of all reporting groups
679387|NCT01983254|B2|Baseline|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
679388|NCT01983254|B1|Baseline|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
679389|NCT01983254|P2|Participant Flow|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
679390|NCT01983254|P1|Participant Flow|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
679391|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
679392|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
679393|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
679394|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
679395|NCT01983254|O2|Outcome|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
679396|NCT01983254|O1|Outcome|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
679397|NCT01983254|E2|Reported Event|Education Program|"6 week access to a web-based, critical illness-specific education program~education program: web-based, ICU-specific education program"
679398|NCT01983254|E1|Reported Event|Coping Skills Training|"6 sessions of weekly telephone-based coping skills training delivered by trained interventionist~coping skills training: 6-session coping skills training program delivered by telephone w/ web augmentation"
679399|NCT01983111|B3|Baseline|Total|Total of all reporting groups
679400|NCT01983111|B2|Baseline|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679401|NCT01983111|B1|Baseline|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679402|NCT01983111|P2|Participant Flow|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679403|NCT01983111|P1|Participant Flow|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679404|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679405|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679764|NCT01979133|O2|Outcome|Week 8|Week 8 Days of alcohol use per week
679406|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679407|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679408|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679409|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679410|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679411|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679412|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679413|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679414|NCT01983111|O2|Outcome|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
679415|NCT01983111|O1|Outcome|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days."
679416|NCT01983111|E2|Reported Event|Tramadol/Acetaminophen|"Oral tablet~tramadol/acetaminophen: Amount of drug ingredients~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.~Dosage and administration:~Adjust dose depending on a patient’s pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 65 subjects who administered the comparator(tramadol/acetaminophen) and had at least one time of safety assessment."
679417|NCT01983111|E1|Reported Event|Buprenorphine|"Patch~buprenorphine: Dosage and administration: This one patch should be attached every 7 days.~Safety was analyzed based on data for AEs, clinical laboratory tests, vital signs, and physical examination in the Safety set which consisted of 69 subjects who administered the study drug(buprenorphine) and had at least one time of safety assessment."
679418|NCT01983020|B5|Baseline|Total|Total of all reporting groups
679419|NCT01983020|B4|Baseline|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
679420|NCT01983020|B3|Baseline|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
679421|NCT01983020|B2|Baseline|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
679422|NCT01983020|B1|Baseline|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
679423|NCT01983020|P4|Participant Flow|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
679424|NCT01983020|P3|Participant Flow|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
679425|NCT01983020|P2|Participant Flow|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
679426|NCT01983020|P1|Participant Flow|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
679427|NCT01983020|O4|Outcome|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
679428|NCT01983020|O3|Outcome|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
679429|NCT01983020|O2|Outcome|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
679430|NCT01983020|O1|Outcome|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
679431|NCT01983020|E4|Reported Event|Placebo|Placebo (saline) given to compare usual treatment against active agents in post operative pain management.
679432|NCT01983020|E3|Reported Event|Ketamine and Lidocaine|"Ketamine infused at 0.25 mg/kg/hour along with lidocaine at 0.5 mg/kg/hour~Lidocaine~Ketamine"
679433|NCT01983020|E2|Reported Event|Lidocaine|"Lidocaine infused at 0.5 mg/kg/hour.~Lidocaine"
679434|NCT01983020|E1|Reported Event|Ketamine|"Ketamine infused at 0.25 mg/kg/hour.~Ketamine"
679435|NCT01982812|B3|Baseline|Total|Total of all reporting groups
679436|NCT01982812|B2|Baseline|Standard AED|"Standard AED regimen~Standard AED: Active comparitor, Standard AED"
679437|NCT01982812|B1|Baseline|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
679438|NCT01982812|P2|Participant Flow|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
679478|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679440|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
679441|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
679442|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
679443|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
679444|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
679445|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
679446|NCT01982812|O2|Outcome|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
679447|NCT01982812|O1|Outcome|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
679448|NCT01982812|E2|Reported Event|Comparison Group|"2014: Children randomized to routine care who then recieved 20mg/kg phenobarbital with additional doses at the managing clinicians discretion~2015: Children randomized to routine care will phenobarbital given at the discretion of the managing clinician but with a max od 20mg/kg load"
679449|NCT01982812|E1|Reported Event|Oral Levetiracetam|"Oral Levetiracetam administered by NG tube.~Oral Levetiracetam: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days"
679450|NCT01982695|B3|Baseline|Total|Total of all reporting groups
679451|NCT01982695|B2|Baseline|Lospartan|Lisinopril
679452|NCT01982695|B1|Baseline|Lisinopril|Lisinopril
679453|NCT01982695|P2|Participant Flow|Losartan|Approximately 0.7 mg/kg/day in oral capsules
679454|NCT01982695|P1|Participant Flow|Lisinopril|Approximately 0.07 mg/kg/day in oral capsules
679455|NCT01982695|O2|Outcome|Losartan|Losartan
679456|NCT01982695|O1|Outcome|Lisinopril|Lisinopril
679457|NCT01982695|E2|Reported Event|Losartan|Losartan
679458|NCT01982695|E1|Reported Event|Lisinopril|Lisinopril
679459|NCT01982539|B1|Baseline|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
679460|NCT01982539|P1|Participant Flow|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
679461|NCT01982539|O1|Outcome|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to subjects with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
679462|NCT01982539|E1|Reported Event|Zipsor® (Liquid Filled Capsules)|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treatment. Drug taken by mouth.
679463|NCT01982292|B3|Baseline|Total|Total of all reporting groups
679464|NCT01982292|B2|Baseline|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679465|NCT01982292|B1|Baseline|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679466|NCT01982292|P2|Participant Flow|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679467|NCT01982292|P1|Participant Flow|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679468|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679469|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679470|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679471|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679472|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679473|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679474|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679475|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679476|NCT01982292|O2|Outcome|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679477|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679765|NCT01979133|O1|Outcome|Baseline|Baseline Days of alcohol use per week
679479|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679481|NCT01982292|O1|Outcome|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679482|NCT01982292|E2|Reported Event|Placebo|Randomized patients received an IV infusion of placebo of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679483|NCT01982292|E1|Reported Event|RLX030 (Serelaxin)|Randomized patients received an IV infusion of 30 μg/kg/day of serelaxin for 48 hours at randomization and at Weeks 4 and 8
679484|NCT01982253|B4|Baseline|Total|Total of all reporting groups
679485|NCT01982253|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
679486|NCT01982253|B2|Baseline|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
679487|NCT01982253|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
679488|NCT01982253|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
679489|NCT01982253|P2|Participant Flow|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
679490|NCT01982253|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
679491|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
679492|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
679493|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
679494|NCT01982253|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
679495|NCT01982253|O2|Outcome|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
679496|NCT01982253|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
679497|NCT01982253|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablet, orally, once daily and fasiglifam- placebo matching tablet, orally, once daily for up to Day 47.
679498|NCT01982253|E2|Reported Event|Fasiglifam 25 mg BID|Fasiglifam 25 mg, tablets, orally, twice daily for up to Day 47.
679499|NCT01982253|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, twice daily for up to Day 47.
679500|NCT01981967|B3|Baseline|Total|Total of all reporting groups
679501|NCT01981967|B2|Baseline|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
679502|NCT01981967|B1|Baseline|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
679503|NCT01981967|P2|Participant Flow|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
679504|NCT01981967|P1|Participant Flow|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
679505|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
679506|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
679507|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
679508|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
679509|NCT01981967|O2|Outcome|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
679510|NCT01981967|O1|Outcome|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
679511|NCT01981967|E2|Reported Event|Booster Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a booster.
679512|NCT01981967|E1|Reported Event|Primary Vaccination Group|Children aged 9 months to less than 5 years who received one injection of IMOJEV® as a primary vaccination.
679513|NCT01981863|B3|Baseline|Total|Total of all reporting groups
679514|NCT01981863|B2|Baseline|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
679515|NCT01981863|B1|Baseline|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
679516|NCT01981863|P2|Participant Flow|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
679517|NCT01981863|P1|Participant Flow|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
679518|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
679519|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
679520|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
679554|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679521|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
680285|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
679522|NCT01981863|O2|Outcome|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm."
679523|NCT01981863|O1|Outcome|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo."
679524|NCT01981863|E2|Reported Event|Placebo, Antifibrinolytic Activity|"Placebo: same IV volume as experimental arm~Placebo: Placebo administered in same volume as in experimental arm.~No adverse events to report."
679525|NCT01981863|E1|Reported Event|Epsilonaminocaproic Acid|"One arm: Epsilonaminocaproic acid 10 gr IV, followed by 1 gr/hr infusion Second arm: placebo~Epsilonaminocaproic acid: One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.~No adverse advents to report."
679526|NCT01981616|B3|Baseline|Total|Total of all reporting groups
679527|NCT01981616|B2|Baseline|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679528|NCT01981616|B1|Baseline|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679529|NCT01981616|P2|Participant Flow|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679530|NCT01981616|P1|Participant Flow|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679531|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679532|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679533|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679534|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679535|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679536|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679537|NCT01981616|O2|Outcome|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679538|NCT01981616|O1|Outcome|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679539|NCT01981616|E2|Reported Event|Placebo|Vedolizumab placebo-matching solution, IV infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679540|NCT01981616|E1|Reported Event|Vedolizumab 750 mg|Vedolizumab 750 mg solution, intravenous (IV) infusion, once on Day 1. Also 3 doses of a hepatitis B vaccine series on Days 4, 32 and 60, and 2 doses of an oral cholera vaccine on Days 4 and 18.
679541|NCT01981473|B4|Baseline|Total|Total of all reporting groups
679542|NCT01981473|B3|Baseline|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679543|NCT01981473|B2|Baseline|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679544|NCT01981473|B1|Baseline|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679545|NCT01981473|P3|Participant Flow|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679546|NCT01981473|P2|Participant Flow|Adalimumab|Participants who had received treatment with Adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679547|NCT01981473|P1|Participant Flow|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679548|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679549|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679550|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679551|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679552|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679553|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679555|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
680286|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
679556|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679557|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679558|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679559|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679560|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679561|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679562|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679563|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679564|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679565|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679566|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679567|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679568|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679569|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679570|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679571|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679572|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679573|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679574|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679575|NCT01981473|O3|Outcome|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679576|NCT01981473|O2|Outcome|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679577|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679578|NCT01981473|O2|Outcome|% AA-|Proportion of participants negative for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
679579|NCT01981473|O1|Outcome|% AA+|Proportion of participants positive for antidrug antibodies among those treated with etanercept versus those treated with monoclonal antibodies (adalimumab or infliximab)
679580|NCT01981473|O2|Outcome|Adalimumab/ Infliximab|Participants who had received treatment with adalimumab or infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679581|NCT01981473|O1|Outcome|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679582|NCT01981473|E3|Reported Event|Infliximab|Participants who had received treatment with infliximab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679583|NCT01981473|E2|Reported Event|Adalimumab|Participants who had received treatment with adalimumab for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679584|NCT01981473|E1|Reported Event|Etanercept|Participants who had received treatment with etanercept for a minimum of 6 months and maximum of 24 months prior to the study assessment visit.
679585|NCT01981356|B3|Baseline|Total|Total of all reporting groups
679586|NCT01981356|B2|Baseline|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679587|NCT01981356|B1|Baseline|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679613|NCT01981057|B3|Baseline|Total|Total of all reporting groups
679615|NCT01981057|B1|Baseline|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679588|NCT01981356|P2|Participant Flow|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679589|NCT01981356|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679590|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679591|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679592|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679593|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679594|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679595|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679596|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679597|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679598|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679599|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679600|NCT01981356|O1|Outcome|Inpatient Psychiatry Unit Staff Members|Barriers and facilitators were assessed through interviews of four inpatient psychiatry unit staff (on nursing assistant, one nurse, two psychologists).
679614|NCT01981057|B2|Baseline|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679766|NCT01979133|O2|Outcome|Week 8|Week 8 Heavy Drinking Days Per Week
679601|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679602|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679603|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679604|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679605|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679606|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679607|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679608|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679609|NCT01981356|O2|Outcome|Treatment as Usual (TAU)|TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.
679610|NCT01981356|O1|Outcome|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679611|NCT01981356|E2|Reported Event|Treatment as Usual (TAU)|"TAU consists of psychopharmacology, case management, and psychotherapy. Additionally, patients randomized to the TAU condition will meet with ACT facilitators for 15 minutes every other day to provide additional support and answer questions, while ensuring not to discuss or suggest the use of therapeutic techniques related to ACT.~Treatment as Usual (TAU): All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate."
679612|NCT01981356|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|Participants randomized to the ACT condition will be provided with the opportunity to attend 4 ACT sessions, all of which will occur within 9 days of the patient's admission to the inpatient unit. Each ACT session will serve as a standalone session, with all essential elements of the treatment briefly presented. Each session will contain a core set of themes and exercises that will be rotated over subsequent sessions (e.g., acceptance of uncontrollable vs. controllable events). Each session will begin with a brief psycho-educational component to address psychotic symptoms, followed by presentation of the ACT model to provide a rationale for treatment. Participants in the ACT condition will also receive treatment as usual.
679616|NCT01981057|P2|Participant Flow|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679617|NCT01981057|P1|Participant Flow|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679618|NCT01981057|O2|Outcome|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679619|NCT01981057|O1|Outcome|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679620|NCT01981057|E2|Reported Event|Individual|"individually prescribed parenteral receipt~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679621|NCT01981057|E1|Reported Event|Numeta|"parenteral receipt prescribed with Numeta~Numeta: parenteral receipt prescribed with Numeta~Individual: parenteral receipt prescribed individually"
679622|NCT01980992|B3|Baseline|Total|Total of all reporting groups
679623|NCT01980992|B2|Baseline|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
679624|NCT01980992|B1|Baseline|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
679625|NCT01980992|P2|Participant Flow|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
679626|NCT01980992|P1|Participant Flow|Placebo Then High Dose Group|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
679627|NCT01980992|O2|Outcome|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
679628|NCT01980992|O1|Outcome|Placebo|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a week 52 7443mg wheat protein oral food challenge (OFC).
679629|NCT01980992|E2|Reported Event|Wheat OIT|2 years on active wheat oral immunotherapy (OIT) with maximum maintenance dose 2035mg wheat powder (1445mg wheat protein), then completed Year 2 7443 mg wheat protein desensitization oral food challenge (OFC); those that passed this OFC stopped active OIT treatment for 8-10 weeks and then completed the Year 2 7443 mg wheat protein tolerance OFC.
679630|NCT01980992|E1|Reported Event|Placebo|52 weeks placebo, then crossed over to active wheat oral immunotherapy (OIT) to a maximum dose of 3870mg wheat powder (2748 mg wheat protein). Placebo subjects who were crossed over received a higher maintenance dose than the Wheat OIT subjects. After this group received 52 weeks of active wheat OIT treatment, they then completed a Week 52 7443mg wheat protein oral food challenge (OFC).
679631|NCT01980940|B9|Baseline|Total|Total of all reporting groups
679632|NCT01980940|B8|Baseline|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679633|NCT01980940|B7|Baseline|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679634|NCT01980940|B6|Baseline|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
679635|NCT01980940|B5|Baseline|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
679636|NCT01980940|B4|Baseline|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
679637|NCT01980940|B3|Baseline|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
679638|NCT01980940|B2|Baseline|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
679639|NCT01980940|B1|Baseline|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
679640|NCT01980940|P8|Participant Flow|Pt 2: Placebo|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679641|NCT01980940|P7|Participant Flow|Pt 2: ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679642|NCT01980940|P6|Participant Flow|Pt 1: Placebo (Deviation)|Participants randomized to a treatment sequence in Part 1 who received single dose placebo gel (1.97 or 3.94 mL) applied topically in error instead of active study drug and dropped out after the first treatment period in the sequence. Included in the safety assessments only.
679643|NCT01980940|P5|Participant Flow|Pt 1: ETOR OD/ ETOR 150 DMSO/ ETOR 75 DMSO/ ETOR 75 PG|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel (DMSO formulation administered in error/overdose), followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
679644|NCT01980940|P4|Participant Flow|Pt 1: ETOR 150 PG/ETOR 150 DMSO/ETOR 75 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel. All treatments were applied topically.
679645|NCT01980940|P3|Participant Flow|Pt 1: ETOR 150 DMSO/ETOR 75 PG/ETOR 150 PG/ETOR 75 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel. All treatments were applied topically.
679646|NCT01980940|P2|Participant Flow|Pt 1: ETOR 75 PG/ETOR 75 DMSO/ETOR 150 DMSO/ETOR 150 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel. All treatments were applied topically.
679647|NCT01980940|P1|Participant Flow|Pt 1: ETOR 75 DMSO/ETOR 150 PG/ETOR 75 PG/ETOR 150 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel, followed by single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel, followed by single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel, followed by single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel. All treatments were applied topically.
679648|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679649|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679650|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
679651|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
679652|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
679653|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
679654|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
679655|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
679656|NCT01980940|O8|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679657|NCT01980940|O7|Outcome|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679658|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
679659|NCT01980940|O5|Outcome|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
679660|NCT01980940|O4|Outcome|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
679661|NCT01980940|O3|Outcome|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
679662|NCT01980940|O2|Outcome|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
679663|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
679664|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679665|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679666|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679667|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679668|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679669|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679670|NCT01980940|O2|Outcome|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679671|NCT01980940|O1|Outcome|ETOR 50 DMSO|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679672|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
679673|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
679674|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
679675|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
679676|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
679678|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
679679|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
679680|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
679681|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
679682|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
679683|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
679684|NCT01980940|O6|Outcome|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
679685|NCT01980940|O5|Outcome|ETOR OD|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
679686|NCT01980940|O4|Outcome|ETOR 150 PG|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
679687|NCT01980940|O3|Outcome|ETOR 150 DMSO|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
679688|NCT01980940|O2|Outcome|ETOR 75 PG|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
679689|NCT01980940|O1|Outcome|ETOR 75 DMSO|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
679690|NCT01980940|E8|Reported Event|Placebo (Pt 2)|Matching placebo to etoricoxib 50 mg 1.31 mL 4% DMSO gel applied topically twice daily to the affected knee for a period of 2 weeks.
679691|NCT01980940|E7|Reported Event|ETOR 50 DMSO (Pt 2)|Etoricoxib 50 mg (1.31 mL, 4% DMSO gel) applied topically twice daily to the affected knee for a period of 2 weeks.
679692|NCT01980940|E6|Reported Event|Placebo (Pt 1) (Deviation)|Single dose placebo (1.97 mL or 3.94 mL) gel applied topically (placebo gel administered in error instead of active study drug formulation).
679693|NCT01980940|E5|Reported Event|ETOR OD (Pt 1)|Single-dose etoricoxib 163 mg (4.30 mL) 4% DMSO gel applied topically (DMSO formulation administered in overdose/error).
679694|NCT01980940|E4|Reported Event|ETOR 150 PG (Pt 1)|Single-dose etoricoxib 150 mg (4.30 mL) 4% PG gel applied topically.
679695|NCT01980940|E3|Reported Event|ETOR 150 DMSO (Pt 1)|Single-dose etoricoxib 150 mg (3.94 mL) 4% DMSO gel applied topically.
679696|NCT01980940|E2|Reported Event|ETOR 75 PG (Pt 1)|Single-dose etoricoxib 75 mg (2.15 mL) 4% PG gel applied topically.
679697|NCT01980940|E1|Reported Event|ETOR 75 DMSO (Pt 1)|Single-dose etoricoxib 75 mg (1.97 mL) 4% DMSO gel applied topically.
679698|NCT01980628|B1|Baseline|Ibrutinib|Patients receive a daily dose of 560 mg of ibrutinib capsules
679699|NCT01980628|P1|Participant Flow|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
679700|NCT01980628|O1|Outcome|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
679701|NCT01980628|O1|Outcome|Ibrutinib|Patients receive daily dose of 560 mg of ibrutinib capsules.
679702|NCT01980628|E1|Reported Event|Ibrutinib|"ibrutinib capsules: 560 mg once daily~ibrutinib"
679703|NCT01980589|B4|Baseline|Total|Total of all reporting groups
679704|NCT01980589|B3|Baseline|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679705|NCT01980589|B2|Baseline|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679706|NCT01980589|B1|Baseline|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679707|NCT01980589|P3|Participant Flow|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679708|NCT01980589|P2|Participant Flow|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679709|NCT01980589|P1|Participant Flow|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679710|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679767|NCT01979133|O1|Outcome|Baseline|Baseline Heavy Drinking Days Per Week
679768|NCT01979133|O2|Outcome|Week 8|Week 8 Mean Standard Drinks Per Week
680083|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
679711|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679712|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679713|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679714|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679715|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679716|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679717|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679718|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679719|NCT01980589|O3|Outcome|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679720|NCT01980589|O2|Outcome|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679721|NCT01980589|O1|Outcome|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679722|NCT01980589|E3|Reported Event|Carfilzomib 56 mg/m²|Participants received 56 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679723|NCT01980589|E2|Reported Event|Carfilzomib 45 mg/m²|Participants received 45 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679724|NCT01980589|E1|Reported Event|Carfilzomib 36 mg/m²|Participants received 36 mg/m² carfilzomib IV infusion on days 1, 2, 8, 9,15, and 16 of each 28 day cycle (on days 1 and 2 of cycle 1, all participants received carfilzomib at 20 mg/m²), cyclophosphamide administered orally at 300 mg/m² on days 1, 8, and 15, and 40 mg dexamethasone on days 1, 8, 15, and 22, for up to eight 28 day cycles, or until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
679725|NCT01980524|B1|Baseline|All Study Participants|On study day 1 subjects received acipimox 250 mg or placebo at 0 and 180 minutes (randomized, controlled, single blinded); after a wash out period of at least two weeks on study day 2 i) subjects who received acipimox 250 mg on study day 1 were administered placebo at 0 and 180 minutes and ii) subjects who received placebo on study day 1 were administered acipimox 250 mg at 0 and 180 minutes (randomized, controlled, single blinded).
679726|NCT01980524|P2|Participant Flow|Placebo|Participants received a placebo capsule at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a acipimox 250 mg at 0 and 180 minutes
679727|NCT01980524|P1|Participant Flow|Acipimox First|Participants received acipimox 250 mg at 0 and 180 minutes on the first study day; after a wash out period of at least 2 weeks a second study day followed where they received a placebo capsule at 0 and 180 minutes
679728|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)~placebo"
679729|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
679730|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)~placebo"
679731|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
679732|NCT01980524|O2|Outcome|Placebo|"1 capsule at 0 and 180 minutes (one day)~placebo"
679733|NCT01980524|O1|Outcome|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
679734|NCT01980524|E2|Reported Event|Acipimox-|"1 Tablet at 0 and 180 minutes (one day)~acipimox"
679735|NCT01980524|E1|Reported Event|Acipimox+|"250 mg at 0 and 180 minutes (one day)~acipimox"
679736|NCT01980095|B3|Baseline|Total|Total of all reporting groups
679737|NCT01980095|B2|Baseline|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
679738|NCT01980095|B1|Baseline|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg."
679739|NCT01980095|P2|Participant Flow|Placebo|Capsules that look like the RHB-105 product but contain no active ingredient.
679740|NCT01980095|P1|Participant Flow|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg"
679741|NCT01980095|O2|Outcome|Active Drug Eradication Failure Subjects|These patients failed h.pylori eradication on study drug (active) and were subsequently treated with standard of care therapy as per the investigator.
679742|NCT01980095|O1|Outcome|Placebo Subjects|These patients failed h.pylori eradication on study drug (placebo) and were subsequently treated with standard of care therapy as per the investigator
679743|NCT01980095|O2|Outcome|Placebo|"Capsules that look like the RHB-105 product but contain no active ingredient.~Placebo: Subjects will take 4 placebo capsules every 8 hours with food for 14 days."
679744|NCT01980095|O1|Outcome|RHB-105|"RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule.~Total daily dose of:~Rifabutin 150 mg~Amoxicillin 3000 mg~Omeprazole 120 mg"
679745|NCT01980095|E2|Reported Event|Placebo|Identical capsules that look like the RHB-105 product but contain no active ingredient.
679746|NCT01980095|E1|Reported Event|RHB-105|RHB-105 is an 'all-in-one' combination oral capsule consisting of 2 different antibiotics and a proton pump inhibitor combined in a single capsule. Total daily dose of: Rifabutin 150 mg, Amoxicillin 3000 mg and Omeprazole 120 mg.
679747|NCT01979185|B3|Baseline|Total|Total of all reporting groups
679748|NCT01979185|B2|Baseline|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
679749|NCT01979185|B1|Baseline|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
679750|NCT01979185|P2|Participant Flow|Simvastatin + SSP-004184SS First|Subjects received Simvastatin 20mg and SSP-004184SS 30mg/kg in Period 1, followed by Simvastatin 20mg during Period 2.
679751|NCT01979185|P1|Participant Flow|Simvastatin First|Subjects received Simvastatin 20mg in Period 1, followed by Simvastatin 20mg and SSP-004184SS 30mg/kg during Period 2.
679752|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
679753|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
679754|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
679755|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
679756|NCT01979185|O2|Outcome|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
679757|NCT01979185|O1|Outcome|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
679758|NCT01979185|E2|Reported Event|Simvastatin + SSP-004184SS|Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1.
679759|NCT01979185|E1|Reported Event|Simvastatin Alone|Administered as a single oral 20 mg dose on Day 1.
679760|NCT01979133|B1|Baseline|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
679761|NCT01979133|P1|Participant Flow|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
679762|NCT01979133|O2|Outcome|Week 8|Week 8 YMRS Score
679776|NCT01979133|E1|Reported Event|Icariin|"Icariin will be given 100 mg/day. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 for participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.~Icariin: Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen."
679777|NCT01979029|B3|Baseline|Total|Total of all reporting groups
679778|NCT01979029|B2|Baseline|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
679779|NCT01979029|B1|Baseline|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
679780|NCT01979029|P2|Participant Flow|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
679781|NCT01979029|P1|Participant Flow|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
679782|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
679783|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
679784|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
679785|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
679786|NCT01979029|O2|Outcome|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
679787|NCT01979029|O1|Outcome|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
679922|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679788|NCT01979029|E2|Reported Event|Left Colic Artery Preserved|"We preserve the left colic artery and resect the No. 253 lymph node during the rectal surgery.~preserving the left colic artery: The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA ."
679789|NCT01979029|E1|Reported Event|High Ligation of IMA|"We performed the high ligation of the inferior mesenteric artery during the rectal surgery.~not preserving the left colic artery: The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves."
679790|NCT01978600|B3|Baseline|Total|Total of all reporting groups
679791|NCT01978600|B2|Baseline|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
679792|NCT01978600|B1|Baseline|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
679793|NCT01978600|P2|Participant Flow|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
679794|NCT01978600|P1|Participant Flow|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
679795|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
679796|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
679797|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
679798|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
679799|NCT01978600|O2|Outcome|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
679800|NCT01978600|O1|Outcome|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
679801|NCT01978600|E2|Reported Event|Timolol|1 drop twice a day (8AM, 8PM) in each eye for 4 weeks
679802|NCT01978600|E1|Reported Event|Simbrinza|1 drop 3 times a day (8AM, 3PM, 10PM) in each eye for 4 weeks
679803|NCT01978145|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 4-week washout period. One inhalation of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI or one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI . Salbutamol/albuterol was provided to use as rescue medication.
679804|NCT01978145|P2|Participant Flow|Sequence 2: FSC MD DPI/Pl CB DPI Then Pl MD DPI/FSC CB DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a MD DPI and one inhalation of Placebo via a CB DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self admnistered one inhalation of matching Placebo via a MD DPI and one inhalation of FSC (250/50 mcg) via a CB DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679805|NCT01978145|P1|Participant Flow|Sequence 1: Pl MD DPI/FSC CB DPI Then FSC MD DPI/Pl CB DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) followed by one inhalation of single capsule containing Fluticasone propionate and salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 4 weeks, participants self administered one inhalation of FSC (250/50 mcg) via the MD DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication
679806|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679807|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679808|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679809|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679810|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679811|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679923|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679812|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679813|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679814|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679815|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679816|NCT01978145|O2|Outcome|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679817|NCT01978145|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679818|NCT01978145|E2|Reported Event|FSC Multi-Dose DPI|Participants received one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via MD DPI plus one inhalation of Placebo self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679819|NCT01978145|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one inhalation of Placebo self administered BID (morning and evening) via MD DPI plus one inhalation of FSC (250/50 mcg) self administered BID (morning and evening) via CB DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 4 weeks. Salbutamol/albuterol was provided to use as rescue medication
679820|NCT01978119|B1|Baseline|Overall Study|All participants received one of the following 2 treatments in each of the two 12-week treatment periods separated by a 3-week washout period. One actuations of FSC (250/50 mcg) self administered twice daily (BID) (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI or one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI. Salbutamol/albuterol was provided to use as rescue medication.
679821|NCT01978119|P2|Participant Flow|Sequence 2: FSC MD-DPI/Pl CB-DPI Then Pl MD-DPI/FSC CB-DPI|Participants self administered one inhalation of FSC (250/50 mcg) via a multi-dose DPI and one inhalation of Placebo via a capsule-based unit dose DPI in the morning and evening in Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self admnistered one inhalation of matching Placebo via a multi-dose DPI and one inhalation of FSC (250/50 mcg) via a capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679822|NCT01978119|P1|Participant Flow|Sequence 1: Pl MD-DPI/FSC CB-DPI Then FSC MD-DPI/Pl CB-DPI|Participants self administered one inhalation of matching Placebo (Pl) via a multi-dose dry powder inhaler (MD DPI) and one inhalation of single capsule containing Fluticasone salmeterol combination (FSC) (250/50 microgram [mcg]) via a capsule-based unit dose (CB) DPI in the morning and evening in the Treatment Period 1 for 12 weeks. After washout period of 3 weeks participants self administered one inhalation of FSC (250/50 mcg) via the multi-dose DPI and one inhalation of of matching Placebo via the capsule-based unit dose DPI in the morning and evening in Treatment Period 2 for 12 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679823|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679824|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679825|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679826|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679981|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679827|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679828|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679829|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679830|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679831|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679832|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679833|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679834|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679835|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679836|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679837|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679838|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679839|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679840|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679841|NCT01978119|O2|Outcome|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679842|NCT01978119|O1|Outcome|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
680001|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679843|NCT01978119|E2|Reported Event|FSC Multi-Dose DPI|Participants received one actuations of FSC (250/50 mcg) self administered BID (morning and evening) via multi-dose DPI plus one actuation of Placebo self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679844|NCT01978119|E1|Reported Event|FSC Capsule-Based Unit Dose DPI|Participants received one actuation of Placebo self administered BID (morning and evening) via multi-dose DPI plus one actuation of FSC (250/50 mcg) self administered BID (morning and evening) via capsule-based unit dose DPI in either of two treatment periods for 12 weeks. Treatment periods were separated by washout period of 3 weeks. Salbutamol/albuterol was provided to use as rescue medication.
679845|NCT01977820|B3|Baseline|Total|Total of all reporting groups
679846|NCT01977820|B2|Baseline|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
679847|NCT01977820|B1|Baseline|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
679848|NCT01977820|P2|Participant Flow|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
679849|NCT01977820|P1|Participant Flow|Sapropterin|Subject was administered with 20 milligram per kilogram (mg/kg) sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
679850|NCT01977820|O2|Outcome|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
679851|NCT01977820|O1|Outcome|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject completed the study according to the study protocol until the study was terminated by the Sponsor.
679852|NCT01977820|E2|Reported Event|Placebo|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive placebo tablets matching to sapropterin orally once daily during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
679853|NCT01977820|E1|Reported Event|Sapropterin|Subject was administered with 20 mg/kg sapropterin tablets orally once daily during the 2-week response test period. The subject upon completing the 2-Week response test period was randomized to receive sapropterin during the 24-week study period. The subject underwent the study assessments and procedures according to the study protocol until the study was terminated by the Sponsor.
679854|NCT01977794|B3|Baseline|Total|Total of all reporting groups
679855|NCT01977794|B2|Baseline|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679856|NCT01977794|B1|Baseline|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679872|NCT01977781|B2|Baseline|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
680023|NCT01977482|B1|Baseline|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
679857|NCT01977794|P2|Participant Flow|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127). Controlled BP = SBP <140 mmHg and DBP <90 mmHg.
679858|NCT01977794|P1|Participant Flow|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 milligram (mg) before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine fixed dose combination(FDC) tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at initial dose of 5mg/5mg once daily for 6 weeks.If blood pressure (BP) was controlled at Week 6(Day 43),same dose continued for next 6 weeks. If BP was not controlled at Day 43,dose was increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks.Subjects who had controlled BP atWeek 12(Day 85),continued same dose that they were receiving for next 6 weeks. If BP was not controlled at Day 85,dose was increased to next level,(Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18(Day 127).Controlled BP=Systolic BP(SBP)<140 millimetre of mercury(mmHg) and Diastolic BP(DBP)<90mmHg.
679859|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679860|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679861|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679862|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679863|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679873|NCT01977781|B1|Baseline|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679864|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679865|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679866|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679867|NCT01977794|O2|Outcome|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679868|NCT01977794|O1|Outcome|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679869|NCT01977794|E2|Reported Event|Bisoprolol Failed Group|Subjects who failed monotherapy with bisoprolol 5 mg before trial inclusion were randomized to bisoprolol failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679870|NCT01977794|E1|Reported Event|Amlodipine Failed Group|Subjects who failed monotherapy with amlodipine 5 mg before trial inclusion were randomized to amlodipine failed group to receive Bisoprolol/Amlodipine FDC tablet. Bisoprolol/Amlodipine FDC tablet was orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If BP was controlled at Week 6 (Day 43), the same dose was continued for next 6 weeks. If the BP was not controlled at Day 43, the dose was increased to Bisoprolol/Amlodipine 5 mg/10 mg or 10 mg/5 mg for next 6 weeks. Subjects who had controlled BP at Week 12 (Day 85), continued with the same dose that they were receiving for next 6 weeks. If their BP was not controlled at Day 85, dose was increased to the next level (Bisoprolol/Amlodipine 5 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/5 mg dose and Bisoprolol/Amlodipine and 10 mg/10 mg for subjects receiving Bisoprolol/Amlodipine 5 mg/10 mg dose) until Week 18 (Day 127). Controlled BP= SBP <140 mmHg and DBP <90 mmHg.
679871|NCT01977781|B3|Baseline|Total|Total of all reporting groups
679903|NCT01977573|B4|Baseline|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
680024|NCT01977482|P6|Participant Flow|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
679874|NCT01977781|P2|Participant Flow|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679875|NCT01977781|P1|Participant Flow|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679876|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679877|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679878|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679879|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679880|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679881|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679882|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679883|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679884|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
680190|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
679885|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679886|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679887|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679888|NCT01977781|O2|Outcome|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679889|NCT01977781|O1|Outcome|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679890|NCT01977781|E2|Reported Event|Methylprednisolone Sodium Succinate|"Topical methylprednisolone sodium succinate suspension will be formulated and aseptically prepared from commercially available sterile dry powder vial preservative-free for intravenous use, SOLU-MEDROL® (Pfizer, Inc.). A formulation of 0.5% (5mg/1ml) concentration of methylprednisolone with diluting solvents, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Methylprednisolone Sodium Succinate"
679891|NCT01977781|E1|Reported Event|Tacrolimus|"Topical tacrolimus suspension will be formulated and aseptically prepared from commercially available intravenous tacrolimus, PROGRAF® (Astellas Pharma US, Inc), and transferred into a sterile dropper container by the MEEI pharmacy. A formulation of 0.05% (5mg/10ml) concentration of tacrolimus with diluting solvent, LiquiTears Ophthalmic Solution (Major Pharmaceuticals, Inc.) will be used. Patients will be instructed to keep refrigerated each bottle after opening for 9 days and keep frozen the unopened bottles up to 45 days. They will also be instructed to shake the bottles at least 20 times before using it.~Tacrolimus"
679892|NCT01977729|B1|Baseline|All Study Participants|
679893|NCT01977729|P1|Participant Flow|All Participants|Only one participant was recruited, but never randomized.
679894|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
679895|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
679896|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
679897|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
679898|NCT01977729|O2|Outcome|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
679899|NCT01977729|O1|Outcome|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
679900|NCT01977729|E2|Reported Event|Switch to SRT Alone|"Sertraline: Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater."
679901|NCT01977729|E1|Reported Event|CBT With SRT|CBT (Cognitive Behavioral Therapy)+SRT (Sertraline) will be scheduled at weeks 9-12, 14, 16, 18, 20 with telephone visits at weeks 15, 17, and 19.
679902|NCT01977573|B5|Baseline|Total|Total of all reporting groups
680025|NCT01977482|P5|Participant Flow|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
679904|NCT01977573|B3|Baseline|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679905|NCT01977573|B2|Baseline|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679906|NCT01977573|B1|Baseline|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679907|NCT01977573|P4|Participant Flow|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679908|NCT01977573|P3|Participant Flow|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679909|NCT01977573|P2|Participant Flow|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679910|NCT01977573|P1|Participant Flow|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679911|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679912|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679913|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679914|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679915|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679916|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679917|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679918|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679919|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679920|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679921|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
680026|NCT01977482|P4|Participant Flow|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
679924|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679925|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679926|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679927|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679928|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679929|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679930|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679931|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679932|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679933|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679934|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679935|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679936|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679937|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679938|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679939|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679940|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679941|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679942|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679943|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679944|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679945|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679946|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679947|NCT01977573|O2|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679948|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679949|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679950|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679951|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679952|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679953|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679954|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679955|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679956|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679957|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679958|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679959|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679960|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679961|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
680279|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
679962|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679963|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679964|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679965|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679966|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679967|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679968|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679969|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679970|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679971|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679972|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679973|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679974|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679975|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679976|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679977|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679978|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679979|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679980|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679982|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679983|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679984|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679985|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679986|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679987|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679988|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679989|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679990|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679991|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679992|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679993|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679994|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679995|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
679996|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
679997|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
679998|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
679999|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
680000|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
680002|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
680003|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
680004|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
680005|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
680006|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
680007|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
680008|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
680009|NCT01977573|O4|Outcome|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
680010|NCT01977573|O3|Outcome|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
680011|NCT01977573|O2|Outcome|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
680012|NCT01977573|O1|Outcome|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
680013|NCT01977573|E4|Reported Event|rhEPO-User Control|RhEPO users were randomly assigned to receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator clinical judgment, for 24 weeks. Participants were allowed to continue rhEPO therapy between Week 24 and 28.
680014|NCT01977573|E3|Reported Event|rhEPO-User GSK1278863|RhEPO users were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863 and did not re-start rhEPO or other ESAs until after the follow-up visit at Week 28 (except in cases where there was a compelling clinical reason [based on Investigator’s opinion] to start rhEPO therapy).
680015|NCT01977573|E2|Reported Event|rhEPO-Naive Control|RhEPO-naive participants were randomly assigned to receive open-label rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, based on the Investigator’s clinical judgment, for 24 weeks. At Week 24, participants stopped taking rhEPO (if applicable) and remained off rhEPO or other Erythropoiesis Stimulating Agents (ESA) until at least the follow-up visit at Week 28.
680016|NCT01977573|E1|Reported Event|rhEPO-Naive GSK1278863|RhEPO-naive participants were randomly assigned to receive GSK1278863 QD for 24 weeks. Participants were blinded to the dose-level they received throughout the study. At Week 24, participants stopped taking GSK1278863, and returned for the follow-up visit at Week 28.
680017|NCT01977482|B7|Baseline|Total|Total of all reporting groups
680018|NCT01977482|B6|Baseline|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680019|NCT01977482|B5|Baseline|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680020|NCT01977482|B4|Baseline|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680021|NCT01977482|B3|Baseline|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680022|NCT01977482|B2|Baseline|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680280|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680027|NCT01977482|P3|Participant Flow|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680028|NCT01977482|P2|Participant Flow|GSK1278863 4 mg|Participants received GSK1278863 4 milligrams (mg) once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680029|NCT01977482|P1|Participant Flow|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680030|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680031|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680032|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680033|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680034|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680035|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680036|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680037|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680038|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680039|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680040|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680041|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680042|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680043|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680044|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680045|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680046|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680047|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680048|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680049|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680050|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680051|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680052|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680053|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680054|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680055|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680056|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680057|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680058|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680059|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680060|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680061|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680062|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680063|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680064|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680065|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680066|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680067|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680068|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680069|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680070|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680071|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680072|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680073|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680074|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680075|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680076|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680077|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680078|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680079|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680080|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680081|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680082|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680084|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680085|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680086|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680087|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680088|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680089|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680090|NCT01977482|O5|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680091|NCT01977482|O4|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680092|NCT01977482|O3|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680093|NCT01977482|O2|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680094|NCT01977482|O1|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680095|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680096|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680097|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680098|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680099|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680100|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680101|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680102|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680103|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680104|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680105|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680106|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680107|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680108|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680109|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680110|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680191|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
680287|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680111|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680112|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680113|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680114|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680115|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680116|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680117|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680118|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680119|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680120|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680121|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680122|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680123|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680124|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680125|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680126|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680127|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680128|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680129|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680130|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680131|NCT01977482|O6|Outcome|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680132|NCT01977482|O5|Outcome|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680133|NCT01977482|O4|Outcome|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680134|NCT01977482|O3|Outcome|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680135|NCT01977482|O2|Outcome|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680136|NCT01977482|O1|Outcome|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680137|NCT01977482|E6|Reported Event|GSK1278863 12 mg|Participants received GSK1278863 12 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680138|NCT01977482|E5|Reported Event|GSK1278863 10 mg|Participants received GSK1278863 10 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680139|NCT01977482|E4|Reported Event|GSK1278863 8 mg|Participants received GSK1278863 8 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680140|NCT01977482|E3|Reported Event|GSK1278863 6 mg|Participants received GSK1278863 6 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680141|NCT01977482|E2|Reported Event|GSK1278863 4 mg|Participants received GSK1278863 4 mg once daily for the first 4 weeks and thereafter, if necessary the dose was adjusted every four weeks to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680142|NCT01977482|E1|Reported Event|Control|Participants received placebo once daily for the first 4 weeks and thereafter received open label rhEPO as required to achieve Hgb within the range of 10.0-11.5 g/dL for the remaining 20 weeks.
680143|NCT01977456|B1|Baseline|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
680144|NCT01977456|P1|Participant Flow|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
680145|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
680146|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
680147|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
680148|NCT01977456|O1|Outcome|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
680149|NCT01977456|E1|Reported Event|Eptifibatide|"All subjects will receive the standard dose of IV rt-PA. All subjects will promptly receive an IV bolus of 135mcg/kg eptifibatide followed by an IV infusion of 0.75 mcg/kg/min eptifibatide for 2 hours.~Eptifibatide: IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen."
680150|NCT01976988|B3|Baseline|Total|Total of all reporting groups
680151|NCT01976988|B2|Baseline|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
680152|NCT01976988|B1|Baseline|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
680153|NCT01976988|P2|Participant Flow|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
680154|NCT01976988|P1|Participant Flow|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
680155|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
680156|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
680185|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
680186|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
680157|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
680158|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course"
680159|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
680160|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
680161|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
680162|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
680163|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
680164|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
680165|NCT01976988|O2|Outcome|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
680166|NCT01976988|O1|Outcome|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
680167|NCT01976988|E2|Reported Event|Pre-op Heparin|"Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units given in the preoperative area prior to surgery, then 8 hours after surgery and continued every 8 hours for the remainder of the patients hospital course"
680168|NCT01976988|E1|Reported Event|Post-op Heparin|"Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course~Heparin: Subcutaneous Heparin 5000 Units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course"
680169|NCT01976871|B1|Baseline|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680170|NCT01976871|P1|Participant Flow|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680187|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
680188|NCT01976845|O3|Outcome|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
680189|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
680171|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680172|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680173|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680174|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680175|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680176|NCT01976871|O1|Outcome|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680177|NCT01976871|E1|Reported Event|Oral Dopamine Agonist to Rotigotine|"During the study, we will switch patients who are not satisfied with their current oral dopamine agonist to rotigotine. Cross-titration will allow determination of the lowest effective dose of rotigotine. We will use as initial guidance the equivalence determined from the Parkinson's Disease trials, in which 1 mg rotigotine was shown to be approximately equivalent to 1-1.5 mg ropinirole or 0.25 -0.375 mg pramipexole. Tolerability, adverse events, and RLS symptom control will be evaluated. These data will provide clinicians with practical guidance to optimize RLS treatment while minimizing adverse events.~Rotigotine: Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator."
680178|NCT01976845|B4|Baseline|Total|Total of all reporting groups
680179|NCT01976845|B3|Baseline|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
680180|NCT01976845|B2|Baseline|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
680181|NCT01976845|B1|Baseline|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
680182|NCT01976845|P3|Participant Flow|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
680183|NCT01976845|P2|Participant Flow|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
680184|NCT01976845|P1|Participant Flow|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
722697|NCT01727141|O4|Outcome|Placebo|b.i.d
680192|NCT01976845|O2|Outcome|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
680193|NCT01976845|O1|Outcome|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
680194|NCT01976845|E3|Reported Event|Saline|"Saline 2 ml~Saline: Saline 2 ml IV, in the pre-op area as a premedication"
680195|NCT01976845|E2|Reported Event|Midazolam|"Midazolam 2 mg IV (2 ml)~Midazolam: Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication"
680196|NCT01976845|E1|Reported Event|Propofol|"Propofol 20 mg IV (2 ml)~Propofol: Propofol (20mg) 2 ml IV, in the pre-op area as a premedication"
680197|NCT01976806|B3|Baseline|Total|Total of all reporting groups
680198|NCT01976806|B2|Baseline|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
680199|NCT01976806|B1|Baseline|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
680200|NCT01976806|P2|Participant Flow|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
680201|NCT01976806|P1|Participant Flow|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
680202|NCT01976806|O2|Outcome|Aspirin & Placebo|"Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months~Aspirin~Placebo (for Docosahexaenoic acid): Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules"
680203|NCT01976806|O1|Outcome|Aspirin & Docosahexaenoic Acid|"Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months~Aspirin~Docosahexaenoic acid"
680204|NCT01976806|E2|Reported Event|Placebo (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
680205|NCT01976806|E1|Reported Event|DHA 2 gm (4 Caps) + Aspirin 81 mg (1 Tablet by Mouth Per Day)|
680206|NCT01976663|B1|Baseline|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
680207|NCT01976663|P1|Participant Flow|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
680208|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
680209|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
680210|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
680211|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
680212|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
680213|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
680214|NCT01976663|O2|Outcome|Control|Nasolabial folds treated with Control.
680215|NCT01976663|O1|Outcome|JUVEDERM VOLIFT® XC|Nasolabial folds treated with JUVEDERM VOLIFT® XC.
680216|NCT01976663|E4|Reported Event|JUVEDERM VOLIFT® XC Asymmetry Correction/Repeat Treatment|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Asymmetry Correction/Repeat Treatment period.
680217|NCT01976663|E3|Reported Event|Not at NLF During Initial/Touch Up Treatment Period|Nasolabial folds treated with JUVEDERM VOLIFT® XC on one side and Control on the other side.
680218|NCT01976663|E2|Reported Event|Control During Initial/Touch Up Treatment Period|Nasolabial folds treated with Control during the Initial/Touch Up period.
680219|NCT01976663|E1|Reported Event|JUVEDERM VOLIFT® XC During Initial/Touch Up|Nasolabial folds treated with JUVEDERM VOLIFT® XC during the Initial/Touch Up period.
680220|NCT01976650|B1|Baseline|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
680221|NCT01976650|P1|Participant Flow|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
680222|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
680223|NCT01976650|O1|Outcome|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
680224|NCT01976650|E1|Reported Event|OZURDEX®|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
680225|NCT01976624|B1|Baseline|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
680226|NCT01976624|P1|Participant Flow|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
680227|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
680228|NCT01976624|O1|Outcome|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
680281|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680282|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680229|NCT01976624|E1|Reported Event|Ganfort®|Patients who received treatment with bimatoprost/timolol (Ganfort®) for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
680230|NCT01976572|B1|Baseline|All Subjects|
680231|NCT01976572|P3|Participant Flow|Treatment C|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan. On Day 13, the first daily dose of colestilan and candesartan was administered together (T0), and on Day 19 candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan.
680232|NCT01976572|P2|Participant Flow|Treatment B|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan. On Day 13, candesartan was administered at 3 hours after (T+3) the first daily dose of colestilan, and on Day 19, the first daily dose of colestilan and candesartan were administered together (T0).
680233|NCT01976572|P1|Participant Flow|Treatment A|On Day 1, a single dose of candesartan (16 mg) was administered. On Day 7, the first daily dose of colestilan (5 g) and candesartan were administered together (T0). On Day 13, candesartan was administered at 1 hour before (T-1) the first daily dose of colestilan, and on Day 19 at 3 hours after (T+3) the first daily dose of colestilan.
680234|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
680235|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
680236|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
680237|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
680238|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
680239|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
680240|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
680241|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
680242|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
680243|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
680244|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
680245|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
680246|NCT01976572|O4|Outcome|T+3hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 3 hour after
680247|NCT01976572|O3|Outcome|T0hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at the same time
680248|NCT01976572|O2|Outcome|T-1hr|Single dose of candesartan (16 mg) with colestilan (5 g three times daily) co-administration at 1 hour before
680249|NCT01976572|O1|Outcome|Candesartan Alone|Single dose of candesartan (16 mg) only
680250|NCT01976572|E3|Reported Event|Candesartan Plus Colestilan (Day 7 to 24)|
680251|NCT01976572|E2|Reported Event|Colestilan Alone (Day 3 to 6)|
680252|NCT01976572|E1|Reported Event|Candesartan Alone (Day 1 to 2)|
680253|NCT01976442|B3|Baseline|Total|Total of all reporting groups
680254|NCT01976442|B2|Baseline|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
680255|NCT01976442|B1|Baseline|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
680256|NCT01976442|P2|Participant Flow|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
680257|NCT01976442|P1|Participant Flow|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
680258|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
680259|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
680260|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
680261|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
680262|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
680263|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
680264|NCT01976442|O2|Outcome|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
680265|NCT01976442|O1|Outcome|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
680266|NCT01976442|E2|Reported Event|Unwashed|Transfusions of red cells were not washed before transfusion into the acute myeloid leukemia patient.
680267|NCT01976442|E1|Reported Event|Washed|Washed red blood cell transfusions given to all patients with acute myeloid leukemia.
680268|NCT01976338|B3|Baseline|Total|Total of all reporting groups
680269|NCT01976338|B2|Baseline|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680270|NCT01976338|B1|Baseline|Ranibizumab 0.5 mg|PRN Intravitreal injection
680271|NCT01976338|P2|Participant Flow|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680272|NCT01976338|P1|Participant Flow|Ranibizumab 0.5 mg|PRN Intravitreal injection
680273|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680274|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680275|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680276|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680277|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680278|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680288|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680289|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680290|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680291|NCT01976338|O2|Outcome|Sham Injection|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680292|NCT01976338|O1|Outcome|Ranibizumab 0.5 mg|PRN Intravitreal injection
680293|NCT01976338|E3|Reported Event|Sham Without Ranibizumab 0.5 mg|sham + ranibizumab 0.5 mg PRN as of Month 6 (hereafter referred to as sham group up to Month 6 and sham with ranibizumab or sham without ranibizumab after Month 6)
680294|NCT01976338|E2|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 6 ranibizumab 0.5 mg PRN intravitreal injection
680295|NCT01976338|E1|Reported Event|Ranibizumab 0.5 mg|PRN Intravitreal injection
680296|NCT01976312|B3|Baseline|Total|Total of all reporting groups
680297|NCT01976312|B2|Baseline|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680298|NCT01976312|B1|Baseline|Ranibizumab 0.5 mg|PRN intravitreal injection
680299|NCT01976312|P2|Participant Flow|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680300|NCT01976312|P1|Participant Flow|Ranibizumab 0.5 mg|PRN intravitreal injection
680301|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680302|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
680303|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680304|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
680305|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680306|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
680307|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680308|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
680309|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680310|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
680311|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680312|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
680313|NCT01976312|O2|Outcome|Sham Injection|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680314|NCT01976312|O1|Outcome|Ranibizumab 0.5 mg|PRN intravitreal injection
680315|NCT01976312|E3|Reported Event|Sham Without Ranibizumab 0.5 mg|Sham without Ranibizumab 0.5mg(hereafter referred to as sham group up to Month 3 and sham without ranibizumab after Month 3
680316|NCT01976312|E2|Reported Event|Sham With Ranibizumab 0.5 mg|As of Month 3, ranibizumab 0.5 mg PRN intravitreal injections
680317|NCT01976312|E1|Reported Event|Ranibizumab 0.5 mg|PRN intravitreal injection
680318|NCT01976299|B3|Baseline|Total|Total of all reporting groups
680319|NCT01976299|B2|Baseline|Standard of Care|
680320|NCT01976299|B1|Baseline|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680321|NCT01976299|P2|Participant Flow|Standard of Care|
680322|NCT01976299|P1|Participant Flow|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680323|NCT01976299|O2|Outcome|Standard of Care|
680324|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680325|NCT01976299|O2|Outcome|Standard of Care|
680326|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680327|NCT01976299|O2|Outcome|Standard of Care|
680328|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680329|NCT01976299|O2|Outcome|Standard of Care|
680330|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680331|NCT01976299|O2|Outcome|Standard of Care|
680332|NCT01976299|O1|Outcome|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680333|NCT01976299|E2|Reported Event|Standard of Care|
680334|NCT01976299|E1|Reported Event|Active Treatment|"Standard of Care with the AVERT system~AVERT"
680335|NCT01976273|B1|Baseline|Subjects Receiving Split-Face Treatment|The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
680336|NCT01976273|P1|Participant Flow|Subjects Receiving Split-Face Treatment|The unit of randomization was the subject who was randomized 1:1 to receive glycolic acid peel on one side of the face, while the contralateral side of the face received the 1064nm Q-switch laser.
680337|NCT01976273|O2|Outcome|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin’s outermost layer.~Glycolic Acid Peels"
680338|NCT01976273|O1|Outcome|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.~1064nm Q-switch Laser"
680339|NCT01976273|E2|Reported Event|Glycolic Acid Peels|"A Glycolic Acid Chemical Peel is a mild skin treatment used to correct uneven texture and color by removing dead cells from the skin’s outermost layer.~Glycolic Acid Peels"
680340|NCT01976273|E1|Reported Event|1064nm Q-switch Laser|"The 1064 Q-Switch Laser is a medical device that uses a focused laser to remove dark pigment (color) from the skin.~1064nm Q-switch Laser"
680341|NCT01975974|B1|Baseline|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
680342|NCT01975974|P1|Participant Flow|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
680343|NCT01975974|O1|Outcome|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
680344|NCT01975974|E1|Reported Event|Ultrasound|"Ultrasound guided peripheral vascular access~Ultrasound: Using ultrasound as a guide for peripheral venous cannulation in obese patients"
680345|NCT01975935|B3|Baseline|Total|Total of all reporting groups
680346|NCT01975935|B2|Baseline|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
680347|NCT01975935|B1|Baseline|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
680348|NCT01975935|P2|Participant Flow|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
680349|NCT01975935|P1|Participant Flow|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
680350|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
680351|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
680352|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
680353|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
680354|NCT01975935|O2|Outcome|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
680355|NCT01975935|O1|Outcome|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
680356|NCT01975935|E2|Reported Event|Amlexanox|"Solfa tablets (Amlexanox 25mg) TID for 2 weeks Solfa tablets (Amlexanox 25mg x 2) TID for 10 weeks~Amlexanox"
680357|NCT01975935|E1|Reported Event|Placebo|"Placebo tablet (TID) 2 weeks Placebo tablets (2 x TID) 10 weeks~Placebo"
680358|NCT01975909|B3|Baseline|Total|Total of all reporting groups
680359|NCT01975909|B2|Baseline|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680360|NCT01975909|B1|Baseline|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680361|NCT01975909|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680362|NCT01975909|P1|Participant Flow|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680363|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680364|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680365|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680378|NCT01975675|B4|Baseline|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680379|NCT01975675|B3|Baseline|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680853|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680380|NCT01975675|B2|Baseline|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680381|NCT01975675|B1|Baseline|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680382|NCT01975675|P4|Participant Flow|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680366|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680367|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680368|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680369|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680370|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680371|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680372|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680373|NCT01975909|O2|Outcome|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680374|NCT01975909|O1|Outcome|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680375|NCT01975909|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"A sham condition of Transcranial Magnetic Stimulation will be used and follow the same protocol as the active stimulation; however no magnetic pulses will be delivered through the scalp.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680376|NCT01975909|E1|Reported Event|Transcranial Magnetic Stimulation (TMS)|"A Magstim 200 (Magstim, UK) and 14cm circular coil positioned tangential to the head will be used to deliver stimuli at 100% of maximum stimulator output. Transcranial Magnetic Stimulation will be applied to three regions: 1) 4cm lateral to the right of the inion, 2) centered on the inion, 3) 4cm lateral to the left of the inion. Five pulses separated by 6 seconds will be delivered with a counter-clockwise current, followed by the same five pulses delivered with a clockwise current, for a total of 10 pulses per region, and 30 pulses per session.~Transcranial Magnetic Stimulation: 0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks."
680377|NCT01975675|B5|Baseline|Total|Total of all reporting groups
680854|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680383|NCT01975675|P3|Participant Flow|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680384|NCT01975675|P2|Participant Flow|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus ribavirin (RBV) tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680385|NCT01975675|P1|Participant Flow|LDV/SOF (Treatment Naive)|Treatment-naive participants received ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for up to 12 weeks.
680386|NCT01975675|O2|Outcome|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680387|NCT01975675|O1|Outcome|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680388|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680389|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680390|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680391|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680392|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680393|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680394|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680395|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680396|NCT01975675|O4|Outcome|LDV/SOF+RBV (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680397|NCT01975675|O3|Outcome|LDV/SOF (Treatment Experienced)|Treatment-experienced participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680398|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680399|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680400|NCT01975675|O2|Outcome|LDV/SOF+RBV (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680401|NCT01975675|O1|Outcome|LDV/SOF (Treatment Naive)|Treatment-naive participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680402|NCT01975675|E2|Reported Event|LDV/SOF+RBV|Participants received LDV/SOF 90/400 mg FDC tablet once daily, plus RBV tablets (600 to 1000 mg daily based on weight) in a divided daily dose for up to 12 weeks.
680403|NCT01975675|E1|Reported Event|LDV/SOF|Participants received LDV/SOF 90/400 mg FDC tablet once daily for up to 12 weeks.
680404|NCT01975467|B3|Baseline|Total|Total of all reporting groups
680405|NCT01975467|B2|Baseline|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
680406|NCT01975467|B1|Baseline|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
680407|NCT01975467|P2|Participant Flow|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
680408|NCT01975467|P1|Participant Flow|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
680409|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
680410|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
680411|NCT01975467|O2|Outcome|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
680412|NCT01975467|O1|Outcome|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
680413|NCT01975467|E2|Reported Event|Test Group - Intramedullary Nail|"Subjects that were treated with an intramedullary nail for their displaced midshaft clavicle fracture.~CRx: The CRx is used to treat mid-shaft, with or without comminution clavicle fractures."
680414|NCT01975467|E1|Reported Event|Control Group - Nonoperative|Subjects that were treated with a sling for their displaced midshaft clavicle fracture.
680415|NCT01975285|B3|Baseline|Total|Total of all reporting groups
722698|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
680416|NCT01975285|B2|Baseline|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680417|NCT01975285|B1|Baseline|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680418|NCT01975285|P2|Participant Flow|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680419|NCT01975285|P1|Participant Flow|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680420|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680421|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680422|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680423|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680424|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680425|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680426|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680427|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680428|NCT01975285|O2|Outcome|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680429|NCT01975285|O1|Outcome|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680430|NCT01975285|E2|Reported Event|Saline Group|"0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc~Saline: 0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc"
680431|NCT01975285|E1|Reported Event|Dexamethasone Group|"0.5% Bupivacaine with 1:200,000epinephrine + Dexamethasone 4mg(1 ml) per 20cc~Dexamethasone: 0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc"
680432|NCT01975246|B3|Baseline|Total|Total of all reporting groups
680433|NCT01975246|B2|Baseline|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
680434|NCT01975246|B1|Baseline|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
680435|NCT01975246|P2|Participant Flow|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
680436|NCT01975246|P1|Participant Flow|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
680437|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
680438|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
680439|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
680440|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
680441|NCT01975246|O2|Outcome|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
680442|NCT01975246|O1|Outcome|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
680443|NCT01975246|E2|Reported Event|Telmisartan+Amlodipine|Subjects who were orally administered once daily with the fixed-dose combination tablet of telmisartan 80 mg and amlodipine 5 mg + placebo matching to hydrochlorothiazide 12.5 mg tablet
680444|NCT01975246|E1|Reported Event|Telmisartan and Amlodipine+HCTZ|Subjects who were orally administered once daily with fixed dose combination (FDC) tablet of telmisartan 80 mg and amlodipine 5 mg+ hydrochlorothiazide (HCTZ) 12.5 mg tablet.
680445|NCT01975220|B4|Baseline|Total|Total of all reporting groups
680446|NCT01975220|B3|Baseline|Low Dose, Fasted|"2 fixed low dose combination (FDC) tablets vs. 4 single tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
680447|NCT01975220|B2|Baseline|High Dose, Fed|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
722699|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
680448|NCT01975220|B1|Baseline|High Dose, Fasted|"1 fixed dose combination (FDC) tablet vs. 3 single tablets under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
680484|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
729485|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
680449|NCT01975220|P6|Participant Flow|Low Dose, Fasted: 4 Single Tablets First, Then 2 FDC Tablets|"4 single tablets first, then 2 fixed low dose combination (FDC) tablets under fasted conditions:~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets;~12.5 mg Empagliflozin/750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
680450|NCT01975220|P5|Participant Flow|Low Dose, Fasted: 2 FDC Tablets First, Then 4 Single Tablets|"2 fixed low dose combination (FDC) tablets first, then 4 single tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets;~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
680451|NCT01975220|P4|Participant Flow|High Dose, Fed: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fed conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
680452|NCT01975220|P3|Participant Flow|High Dose, Fed: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
680453|NCT01975220|P2|Participant Flow|High Dose, Fasted: 3 Single Tablets First, Then 1 FDC Tablet|"3 single tablets first, then 1 fixed dose combination (FDC) tablet under fasted conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets;~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
680454|NCT01975220|P1|Participant Flow|High Dose, Fasted: 1 FDC Tablet First, Then 3 Single Tablets|"1 fixed dose combination (FDC) tablet first, then 3 single tablets under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin extended release (XR), FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet;~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
680455|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
680456|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
680457|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680458|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
680459|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680460|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
680461|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
680462|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
680463|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680464|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
680465|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680466|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
680467|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
680468|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
680469|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680470|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
680471|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680472|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
680473|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
680474|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
680475|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680476|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
680477|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680478|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
680479|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablets Empagliflozin / 3 x 500 mg tablets Metformin XR
680480|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
680481|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680482|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
680483|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
729486|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
680485|NCT01975220|O6|Outcome|Low Dose, Fasted: 4 Single Tablets|4 single tablets, low dose, fasted: 1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR
680486|NCT01975220|O5|Outcome|Low Dose, Fasted: 2 FDC Tablets|2 FDC tablets, low dose, fasted: 12.5 mg Empagliflozin / 750 mg Metformin XR
680487|NCT01975220|O4|Outcome|High Dose, Fed: 3 Single Tablets|3 single tablets, high dose, fed: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680488|NCT01975220|O3|Outcome|High Dose, Fed: 1 FDC Tablet|1 FDC tablet, high dose, fed: 25 mg Empagliflozin/1000 mg Metformin XR
680489|NCT01975220|O2|Outcome|High Dose, Fasted: 3 Single Tablets|3 single tablets, high dose, fasted: 1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR
680490|NCT01975220|O1|Outcome|High Dose, Fasted: 1 FDC Tablet|1 FDC tablet, high dose, fasted: 25 mg Empagliflozin/1000 mg Metformin XR (extended release)
680491|NCT01975220|E6|Reported Event|Low Dose, Fasted: 4 Single Tablets|"4 single tablets under fed conditions:~1 x 25 mg tablet Empagliflozin / 3 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 3x Metformin XR tablets"
680492|NCT01975220|E5|Reported Event|Low Dose, Fasted: 2 FDC Tablets|"2 fixed dose combination (FDC) tablets under fasted conditions:~12.5 mg Empagliflozin / 750 mg Metformin XR FDC tablets: Experimental: low dose Empagliflozin/Metformin XR, 2 FDC tablets"
680493|NCT01975220|E4|Reported Event|High Dose, Fed: 3 Single Tablets|"3 single tablets under fed conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
680494|NCT01975220|E3|Reported Event|High Dose, Fed: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fed conditions:~25 mg Empagliflozin/1000 mg Metformin XR, FDC: Experimental, high dose Empagliflozin/Metformin XR,FDC tablet"
680495|NCT01975220|E2|Reported Event|High Dose, Fasted: 3 Single Tablets|"3 single tablets under fasted conditions:~1 x 25 mg tablet Empagliflozin / 2 x 500 mg tablets Metformin XR: Active Comparator: 1x Empagliflozin / 2x Metformin XR tablets"
680496|NCT01975220|E1|Reported Event|High Dose, Fasted: 1 FDC Tablet|"1 fixed dose combination (FDC) tablet under fasted conditions:~25 mg Empagliflozin/1000 mg Metformin XR (extended release), FDC: Experimental, high dose Empagliflozin/Metformin XR, FDC tablet"
680497|NCT01974895|B3|Baseline|Total|Total of all reporting groups
680498|NCT01974895|B2|Baseline|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680499|NCT01974895|B1|Baseline|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680500|NCT01974895|P2|Participant Flow|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680501|NCT01974895|P1|Participant Flow|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680502|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680503|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680504|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680505|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680506|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680507|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680508|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680509|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680510|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680511|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680512|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680513|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680514|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680515|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680516|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680517|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680518|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680519|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680520|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680521|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680522|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
729487|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
680523|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680524|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680525|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680526|NCT01974895|O2|Outcome|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680527|NCT01974895|O1|Outcome|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680528|NCT01974895|E2|Reported Event|Fluzone Group|Subjects received 1 or 2 doses of Fluzone® vaccine at Day 0 or Days 0 and 28, depending on age and priming status.
680529|NCT01974895|E1|Reported Event|FluLaval Quadrivalent Group|Subjects received 1 or 2 doses of FluLaval® Quadrivalent vaccine at Day 0 or Days 0 and 28, depending on age and vaccine priming status.
680530|NCT01974817|B1|Baseline|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
680531|NCT01974817|P1|Participant Flow|Vaccine|"Patients will receive one dose of 0.5 ml 13-valent conjugate pneumococcal vaccine (Prevnar-13) intra-muscularly.~13-valent conjugate pneumococcal vaccine: 0.5ml IM for one dose"
680532|NCT01974817|O1|Outcome|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
680533|NCT01974817|E1|Reported Event|Vaccine Arm|A total of 17 patients received 1 dose of 13-valent pneumococcal conjugate vaccine.
680534|NCT01974752|B3|Baseline|Total|Total of all reporting groups
680535|NCT01974752|B2|Baseline|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
680536|NCT01974752|B1|Baseline|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
680537|NCT01974752|P2|Participant Flow|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
680538|NCT01974752|P1|Participant Flow|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
680539|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
680540|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
680541|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
680542|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
680543|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
680544|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
680545|NCT01974752|O2|Outcome|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
680546|NCT01974752|O1|Outcome|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
680547|NCT01974752|E2|Reported Event|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2|Selumetinib 75 mg BD + Dacarbazine 1000 mg/m2
680548|NCT01974752|E1|Reported Event|Placebo + Dacarbazine 1000 mg/m2|Placebo + Dacarbazine 1000 mg/m2
680549|NCT01974700|B3|Baseline|Total|Total of all reporting groups
680550|NCT01974700|B2|Baseline|No Anti-epileptic Treatment|
680551|NCT01974700|B1|Baseline|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
680552|NCT01974700|P2|Participant Flow|No Anti-epileptic Treatment|
680553|NCT01974700|P1|Participant Flow|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
680554|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
680555|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
680556|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
680557|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
680558|NCT01974700|O2|Outcome|No Anti-epileptic Treatment|
680559|NCT01974700|O1|Outcome|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
680560|NCT01974700|E2|Reported Event|No Anti-epileptic Treatment|
680561|NCT01974700|E1|Reported Event|Levetiracetam|Levetiracetam: 500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
680562|NCT01974323|B3|Baseline|Total|Total of all reporting groups
680563|NCT01974323|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680564|NCT01974323|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680565|NCT01974323|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680566|NCT01974323|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680567|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680568|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680569|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680570|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680571|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680572|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
729488|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
680573|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680574|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680575|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680576|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680577|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680578|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680579|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680580|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680581|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680582|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680583|NCT01974323|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680584|NCT01974323|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680585|NCT01974323|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680586|NCT01974323|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680587|NCT01974245|B3|Baseline|Total|Total of all reporting groups
680588|NCT01974245|B2|Baseline|Cholecalciferol|Cholecalciferol: 100,000 IU/week
680589|NCT01974245|B1|Baseline|Placebo|100 drops/week
680590|NCT01974245|P2|Participant Flow|Cholecalciferol|Cholecalciferol: 100,000 IU/week
680591|NCT01974245|P1|Participant Flow|Placebo|100 drops placebo solution/week
680592|NCT01974245|O2|Outcome|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
680593|NCT01974245|O1|Outcome|Placebo|100 drops/week for 12 weeks
680594|NCT01974245|E2|Reported Event|Cholecalciferol|Cholecalciferol: 100,000 IU/week for 12 weeks
680595|NCT01974245|E1|Reported Event|Placebo|100 drops/week for 12 weeks
680596|NCT01974141|B3|Baseline|Total|Total of all reporting groups
680597|NCT01974141|B2|Baseline|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680598|NCT01974141|B1|Baseline|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680599|NCT01974141|P2|Participant Flow|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680600|NCT01974141|P1|Participant Flow|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680601|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680602|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680603|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680604|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680605|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680606|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680607|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680608|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680609|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680610|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680611|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680612|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680613|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680614|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680615|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680616|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680617|NCT01974141|O2|Outcome|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680618|NCT01974141|O1|Outcome|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680619|NCT01974141|E2|Reported Event|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680620|NCT01974141|E1|Reported Event|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
680621|NCT01973777|B1|Baseline|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
680622|NCT01973777|P1|Participant Flow|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
680623|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
680624|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
680625|NCT01973777|O1|Outcome|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
680626|NCT01973777|E1|Reported Event|IUB Inserted|"There is one arm of women who will have IUBs inserted~IUB: intrauterine contraceptive device"
680627|NCT01973608|B5|Baseline|Total|Total of all reporting groups
680628|NCT01973608|B4|Baseline|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680629|NCT01973608|B3|Baseline|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680630|NCT01973608|B2|Baseline|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680631|NCT01973608|B1|Baseline|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680632|NCT01973608|P4|Participant Flow|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680633|NCT01973608|P3|Participant Flow|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680634|NCT01973608|P2|Participant Flow|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680635|NCT01973608|P1|Participant Flow|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site was targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680746|NCT01973218|P2|Participant Flow|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680661|NCT01973595|O4|Outcome|No Almonds Consumption Control (Children)|"Children were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
680859|NCT01972776|E2|Reported Event|Part 1: QBM076 B.I.D 75 mg|Part 1: QBM076 B.I.D 75 mg
680636|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680637|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680638|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680639|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. One site was targeted and was received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose was 18 Gy (3 x 6 Gy).
680640|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680641|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680642|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680643|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680644|NCT01973608|O4|Outcome|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680659|NCT01973595|P2|Participant Flow|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
680660|NCT01973595|P1|Participant Flow|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680855|NCT01972776|E6|Reported Event|Part 2:QBM076 B.I.D Placebo|Part 2:QBM076 B.I.D Placebo
680645|NCT01973608|O3|Outcome|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680646|NCT01973608|O2|Outcome|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680647|NCT01973608|O1|Outcome|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680648|NCT01973608|E4|Reported Event|MSB0010445 High Dose Cohort 2.4 mg/kg|MSB0010445 was administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680649|NCT01973608|E3|Reported Event|MSB0010445 High Dose Cohort 1.8 mg/kg|MSB0010445 was administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680650|NCT01973608|E2|Reported Event|MSB0010445 Intermediate Dose Cohort 1.0 mg/kg|MSB0010445 was administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680651|NCT01973608|E1|Reported Event|MSB0010445 Low Dose Cohort 0.3 mg/kg|MSB0010445 was administered at a single dose of 0.3 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 was performed 3 days after the last dose of SBRT to the targeted reference lesion. SBRT was administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions. If one site was targeted subject received 3 fractions (1 per day) of 8 Gy each (total: 24 Gy). If the target lesion was located in the thorax, the maximum total dose administered was 18 Gy (3 x 6 Gy).
680652|NCT01973595|B5|Baseline|Total|Total of all reporting groups
680653|NCT01973595|B4|Baseline|No Almonds, Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
680654|NCT01973595|B3|Baseline|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste"
680655|NCT01973595|B2|Baseline|No Almonds, Then Almonds (Parents)|Parents were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
680656|NCT01973595|B1|Baseline|Almonds, Then no Almonds (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680657|NCT01973595|P4|Participant Flow|No Almonds Then Almonds (Children)|Children were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.
680658|NCT01973595|P3|Participant Flow|Almonds, Then no Almonds (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks. After a washout period of 4 weeks, they then received control diet.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680662|NCT01973595|O3|Outcome|Almonds Consumption (Children)|"Children were asked to consume 0.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680663|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
680664|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680665|NCT01973595|O2|Outcome|No Almond Consumption Control|"Participants were asked not to consume almonds for 3 weeks. After a washout period of 4 weeks, they then received the almond intervention diet.~Each group received the almond intervention and the no almond consumption control."
680666|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680667|NCT01973595|O2|Outcome|No Almonds Consumption Control (Parents)|"Parents were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
680668|NCT01973595|O1|Outcome|Almonds Consumption (Parents)|"Parents were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680669|NCT01973595|O2|Outcome|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
680670|NCT01973595|O1|Outcome|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680671|NCT01973595|E2|Reported Event|No Almonds Consumption Control|"Participants were asked not to consume almonds for 3 weeks.~Each group received the almond intervention and the no almond consumption control."
680672|NCT01973595|E1|Reported Event|Almonds Consumption|"Participants were asked to consume 1.5 ounces of almonds or almond paste per day for 3 weeks.~Each group received the almond intervention and the no almond consumption control.~Almonds: Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste."
680673|NCT01973491|B1|Baseline|ATX-MS-1467|Subjects received ATX-MS-1467 50 mcg, 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680674|NCT01973491|P1|Participant Flow|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680675|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680676|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680677|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680678|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680679|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680680|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680681|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680682|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680683|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680684|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680685|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680686|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
722868|NCT01726023|O2|Outcome|Avibactam(1)|15 minutes before or after
680748|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680687|NCT01973491|O1|Outcome|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680688|NCT01973491|E1|Reported Event|ATX-MS-1467|Subjects received ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
680689|NCT01973439|B1|Baseline|Single Arm|This is a single arm crossover study First intervention: PK assessment while on Twice Daily Abacavir Second intervention: PK assessment while on Once Daily Abacavir
680690|NCT01973439|P1|Participant Flow|Single Arm|"This is a single arm crossover study~st intervention: PK assessment while on Twice Daily Abacavir~nd intervention: PK assessment while on Once Daily Abacavir"
680691|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
680692|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
680693|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
680694|NCT01973439|O1|Outcome|Single Arm|This is a single arm study. First intervention: PK assessment of Twice Daily Abacavir (Week 0) Second intervention: PK assessment of Once Daily Abacavir (Week 4)
680695|NCT01973439|E1|Reported Event|Abacavir Once Versus Twice Daily|This is a single arm study. Intervention 1: PK assessment while on Twice Daily Abacavir (Week 0) Intervention 2: PK assessment while on Once Daily Abacavir (Week 4)
680696|NCT01973413|B3|Baseline|Total|Total of all reporting groups
680697|NCT01973413|B2|Baseline|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
680698|NCT01973413|B1|Baseline|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
680699|NCT01973413|P2|Participant Flow|Camp Study|"The second phase of this proposal was the in-camp studies. The same health care providers that conducted the inpatient studies conducted the camp studies. They monitored all campers on closed-loop control in real-time. Participants were randomized to either closed-loop (experimental) or sensor-augmented therapy (control) for the first night and then crossed over every other night to the other therapy over the course of the 5- to 6-day camp session (i.e. on DiAs CTR every other night). Since participants were not always successfully completing a closed-loop control night, the pattern could not hold throughout the entire trial. Thus, there are numerous intervention sequences.~Those assigned to DiAs closed-loop control were remotely monitored throughout the night. Those assigned to the control group were not monitored remotely overnight, but they were wearing Dexcom G4 Platinum sensors with active low and high sensor glucose alarms."
680700|NCT01973413|P1|Participant Flow|Inpatient Study|The first phase of this study tested the feasibility of initializing the DiAs CTR system in a clinical research center. We tested the procedures that would occur with the camp studies, from consenting the subjects, obtaining morning glucose readings, initializing the sensor in the early afternoon, having some light activity in the evening, a bedtime snack, and initializing the closed-loop system within 30 minutes before they go to bed. We also tested how the system would perform using the same calibration and blood glucose monitoring that would be done at camp. In the inpatient study mimicked some camp activities by having the subjects have 20-30 minutes of aerobic activity in the afternoon and in the evening after dinner. The data from the inpatient studies was reviewed by the Data Safety Monitoring Board (DSMB) before we proceeded with the Phase 2 summer camp studies.
680701|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
680702|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
680703|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
680726|NCT01973231|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680704|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
680705|NCT01973413|O2|Outcome|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
680706|NCT01973413|O1|Outcome|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
680707|NCT01973413|E2|Reported Event|Control: Sensor-Augmented Pump Therapy|Subjects will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. They will not use the Diabetes Assistant (DiAs) nor have remote monitoring.
680708|NCT01973413|E1|Reported Event|Experimental: Closed-Loop Control|"Subjects will use the Diabetes Assistant (DiAs) and will wear a Tandem t:slim insulin pump and a Dexcom G4 Platinum sensor with active low and high sensor glucose alarms. Subjects will be remotely monitored throughout the night in real time.~Diabetes Assistant (DiAs): The Control-to-Range (CTR)algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range."
680709|NCT01973387|B3|Baseline|Total|Total of all reporting groups
680710|NCT01973387|B2|Baseline|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
680711|NCT01973387|B1|Baseline|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
680712|NCT01973387|P2|Participant Flow|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
680713|NCT01973387|P1|Participant Flow|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
680714|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
680715|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
680716|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
680717|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
680718|NCT01973387|O2|Outcome|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
680719|NCT01973387|O1|Outcome|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
680720|NCT01973387|E2|Reported Event|Rituximab|Treatment Arm B received rituximab intravenous (IV) infusion 375 milligram per meter square (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m^2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); 500 mg/m^2 on Day 1 of Cycles 3-6 (Weeks 9-24).
680721|NCT01973387|E1|Reported Event|Ibrutinib|Treatment Arm A received 420 milligram (mg) ibrutinib (3*140-mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment until disease progression or unacceptable toxicity, whichever occurs first.
680722|NCT01973231|B3|Baseline|Total|Total of all reporting groups
680723|NCT01973231|B2|Baseline|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680724|NCT01973231|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680725|NCT01973231|P2|Participant Flow|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680856|NCT01972776|E5|Reported Event|Part 2: QBM076 B.I.D 150 mg|Part 2: QBM076 B.I.D 150 mg
680727|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680728|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680729|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680730|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680731|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680732|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680733|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680734|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680735|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680736|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680737|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680738|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680739|NCT01973231|O2|Outcome|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680740|NCT01973231|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680741|NCT01973231|E2|Reported Event|Lixisenatide|Lixisenatide was administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000mg/day and up to 3000mg/day) for a total duration of 26 weeks. Starting dose of lixisenatide was 10 µg once daily, the dose was escalated to 20 µg once daily from day 15 after randomisation.
680742|NCT01973231|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c.; under the skin) once daily in addition to the subject's stable pre-trial metformin (maximum tolerated dose, equal to or above 1000 mg/day and up to 3000 mg/day) for a total duration of 26 weeks. Starting dose of liraglutide was 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day was reached.
680743|NCT01973218|B3|Baseline|Total|Total of all reporting groups
680744|NCT01973218|B2|Baseline|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680745|NCT01973218|B1|Baseline|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680747|NCT01973218|P1|Participant Flow|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680749|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680750|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680751|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680752|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680753|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680754|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680755|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680756|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680757|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680758|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680759|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680760|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680761|NCT01973218|O1|Outcome|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680762|NCT01973218|O2|Outcome|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680763|NCT01973218|O1|Outcome|rMenb|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680764|NCT01973218|E3|Reported Event|Total|Total of subjects
680765|NCT01973218|E2|Reported Event|Placebo/MenACWY|Subjects received one dose of saline placebo (Day 1) and one dose of MenACWY-CRM vaccine (Day 31) in the study
680766|NCT01973218|E1|Reported Event|rMENB|Subjects received two doses of rMenB+OMV NZ vaccine (at Day 1 and Day 31) in the study
680767|NCT01973205|B3|Baseline|Total|Total of all reporting groups
680768|NCT01973205|B2|Baseline|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
680769|NCT01973205|B1|Baseline|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
680770|NCT01973205|P2|Participant Flow|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
680771|NCT01973205|P1|Participant Flow|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
680772|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
680773|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
680774|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
680775|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
680776|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
680777|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
680778|NCT01973205|O2|Outcome|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
680779|NCT01973205|O1|Outcome|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
680780|NCT01973205|E2|Reported Event|Acetaminophen 250 mg and Aspirin 250 mg|"2 tablets each containing Acetaminophen 250 mg and aspirin 250 mg~Acetaminophen 250 mg and Aspirin 250 mg: 2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg"
680781|NCT01973205|E1|Reported Event|Placebo|"2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets~Placebo: 2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets"
680782|NCT01972776|B7|Baseline|Total|Total of all reporting groups
680783|NCT01972776|B6|Baseline|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680784|NCT01972776|B5|Baseline|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680785|NCT01972776|B4|Baseline|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
680786|NCT01972776|B3|Baseline|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680787|NCT01972776|B2|Baseline|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680788|NCT01972776|B1|Baseline|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680789|NCT01972776|P6|Participant Flow|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680790|NCT01972776|P5|Participant Flow|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680791|NCT01972776|P4|Participant Flow|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
680792|NCT01972776|P3|Participant Flow|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
729489|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
680793|NCT01972776|P2|Participant Flow|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680794|NCT01972776|P1|Participant Flow|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680795|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680796|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680797|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680798|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680799|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680800|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680801|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680802|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680803|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680804|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680805|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680806|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680807|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680808|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680809|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
680810|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680811|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680812|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680813|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
680814|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680815|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680816|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680817|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
680818|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680819|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680820|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680821|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
680822|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680823|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680824|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680825|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680826|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680827|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680828|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680829|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680830|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680831|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680832|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680833|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680834|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680835|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680836|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680837|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680838|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680839|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680840|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680841|NCT01972776|O2|Outcome|QBM076 Part 1 Cohort 2|Participants received QBM076 75 mg bid for 14 days.
680842|NCT01972776|O1|Outcome|QBM076 Part 1 Cohort 1|Participants received QBM076 25 mg bid for 14 days.
680843|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680844|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680845|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680846|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680847|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680848|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680849|NCT01972776|O2|Outcome|Placebo Part 2|Participants received matching placebo bid for 8 weeks.
680850|NCT01972776|O1|Outcome|QBM076 Part 2|Participants received QBM076 150 mg bid for 8 weeks.
680851|NCT01972776|O4|Outcome|Placebo Part 1|Participants in each cohort received matching placebo bid for 14 days.
680852|NCT01972776|O3|Outcome|QBM076 Part 1 Cohort 3|Participants received QBM076 150 mg bid for 14 days.
680857|NCT01972776|E4|Reported Event|Part 1: Placebo|Part 1: Placebo
680858|NCT01972776|E3|Reported Event|Part 1: QBM076 B.I.D 150 mg|Part 1: QBM076 B.I.D 150 mg
680860|NCT01972776|E1|Reported Event|Part 1: QBM076 B.I.D 25 mg|Part 1: QBM076 B.I.D 25 mg
680861|NCT01972659|B3|Baseline|Total|Total of all reporting groups
680862|NCT01972659|B2|Baseline|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680863|NCT01972659|B1|Baseline|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680864|NCT01972659|P2|Participant Flow|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680865|NCT01972659|P1|Participant Flow|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680866|NCT01972659|O2|Outcome|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680867|NCT01972659|O1|Outcome|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680868|NCT01972659|E2|Reported Event|Sugammadex and Magnesium Sulphate|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 magnesium: 50 mg/kg iv bolus plus continuous infusion until the end of surgery~Magnesium Sulphate: Experimental :~50 mg/kg bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680869|NCT01972659|E1|Reported Event|Sugammadex and Placebo|"sugammadex: 4 mg/kg iv bolus at the end of the surgery at a TOF count of 1 placebo: isotonic saline (%0.9 NaCl) 50 mg/kg iv bolus plus 15 mg/kg continuous infusion until the end of surgery~placebo: Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion~sugammadex: 4 mg/kg iv bolus at the end of the surgery"
680870|NCT01972516|B3|Baseline|Total|Total of all reporting groups
680871|NCT01972516|B2|Baseline|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680872|NCT01972516|B1|Baseline|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680873|NCT01972516|P2|Participant Flow|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680874|NCT01972516|P1|Participant Flow|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680875|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680876|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680877|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680878|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680879|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680880|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680881|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680964|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
722869|NCT01726023|O1|Outcome|Ceftazidime(1)|15 minutes before or after
680967|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
729490|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
680882|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680883|NCT01972516|O2|Outcome|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680884|NCT01972516|O1|Outcome|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680885|NCT01972516|E2|Reported Event|Standard Care|Participants in the non-interventional arm will not receive study treatment, and will receive standard clinical observation and study assessments. Patients will continue to be observed in the absence of disease progression or unacceptable toxicities.
680886|NCT01972516|E1|Reported Event|Tivozanib|Tivozanib hydrochloride will be administered orally, at a dose of 1.5 mg/day, beginning on Day 1 of Cycle 1. Subjects will receive tivozanib hydrochloride once daily for 3 weeks followed by 1 week off treatment. One cycle is defined as 4 weeks. Cycles will be repeated every 4 weeks in the absence of disease progression or unacceptable toxicities.
680887|NCT01972438|B3|Baseline|Total|Total of all reporting groups
680888|NCT01972438|B2|Baseline|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680889|NCT01972438|B1|Baseline|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680890|NCT01972438|P2|Participant Flow|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680891|NCT01972438|P1|Participant Flow|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680892|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680893|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680894|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680895|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680896|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680897|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680898|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680899|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680900|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680901|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680902|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680903|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680904|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680905|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680906|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680907|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680908|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680909|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680910|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680911|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680912|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680913|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680914|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680915|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680916|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680917|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680918|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680919|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680920|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680921|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680922|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680923|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680924|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680925|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680926|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680927|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680928|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680929|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680930|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680931|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680965|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680932|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680933|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680934|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680935|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680936|NCT01972438|O2|Outcome|Saline - ASEDs|"Participants administer control (normal saline) eye drops daily for the first three months, then crossover to administer autologous serum eye drops (ASEDs) daily beginning at Month 3 through Month 6.~Saline - ASEDs: Control Intervention"
680937|NCT01972438|O1|Outcome|ASEDs - Saline|"Participants administer autologous serum eye drops (ASEDs) daily for the first three months, then crossover to administer control (normal saline) eye drops daily beginning at Month 3 through Month 6.~ASEDs - Saline: Experimental Intervention"
680938|NCT01972438|E4|Reported Event|No Intervention|Adverse event occurred prior to participants receiving either intervention. Neither ASEDs nor normal saline eye drops were being taken when the event occurred.
680939|NCT01972438|E3|Reported Event|ASEDs or Saline|Adverse event occurred after the Month 6 visit when participants had the option of continuing either ASEDs or normal saline eye drops daily if desired.
680940|NCT01972438|E2|Reported Event|Saline|Adverse event occurred when participants were receiving control (normal saline) eye drops daily during the crossover period (first six months) of the study.
680941|NCT01972438|E1|Reported Event|ASEDs|Adverse event occurred when participants were receiving autologous serum eye drops (ASEDs) daily during the crossover period (first six months) of the study.
680942|NCT01972152|B1|Baseline|Total Study Group|Includes all 30 randomized subjects
680943|NCT01972152|P6|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 1 mg, Then G-Pen(TM) 0.5 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 3.
680944|NCT01972152|P5|Participant Flow|Lilly 1 mg First, Then G-Pen(TM) 0.5 mg, Then G-Pen(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
680945|NCT01972152|P4|Participant Flow|G-Pen(TM) 1 mg First, Then Lilly 1 mg, Then G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection of at treatment visit 2 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 3.
680946|NCT01972152|P3|Participant Flow|G-Pen(TM) 1 mg First, Then G-Pen(TM) 0.5 mg , Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 0.5 mg SC injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
680947|NCT01972152|P2|Participant Flow|G-Pen(TM) 0.5 mg First, Then Lilly 1 mg, Then G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 2, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 3.
680948|NCT01972152|P1|Participant Flow|G-Pen(TM) 0.5 mg First, Then G-Pen(TM) 1 mg, Then Lilly 1 mg|G-Pen(TM) (glucagon injection), single 0.5 mg subcutaneous (SC) injection at treatment visit 1 followed by a 3-14 day washout, G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection at treatment visit 2 followed by a 3-14 day washout, Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection at treatment visit 3.
680949|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
680950|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680951|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680952|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
680953|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680954|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680955|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
680956|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680957|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680958|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
680959|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680960|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680961|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
680962|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680963|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680966|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680968|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680969|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680970|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
680971|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680972|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680973|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection
680974|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|G-Pen(TM) (glucagon injection), single 0.5 mg SC injection
680975|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|G-Pen(TM) (glucagon injection), single 1 mg SC injection
680976|NCT01972152|O3|Outcome|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
680977|NCT01972152|O2|Outcome|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
680978|NCT01972152|O1|Outcome|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
680979|NCT01972152|E3|Reported Event|Lilly Glucagon(TM) 1 mg|"Lilly Glucagon(TM) [glucagon for injection (rDNA origin)], single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
680980|NCT01972152|E2|Reported Event|G-Pen(TM) 0.5 mg|"G-Pen(TM) (glucagon injection), single 0.5 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
680981|NCT01972152|E1|Reported Event|G-Pen(TM) 1 mg|"G-Pen(TM) (glucagon injection), single 1 mg SC injection~G-Pen(TM) 1 mg~Lilly Glucagon(TM) 1 mg~G-Pen(TM) 0.5 mg"
680982|NCT01971723|B3|Baseline|Total|Total of all reporting groups
680983|NCT01971723|B2|Baseline|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
680984|NCT01971723|B1|Baseline|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680985|NCT01971723|P2|Participant Flow|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
680986|NCT01971723|P1|Participant Flow|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680987|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
680988|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680989|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
680990|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680991|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681033|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681034|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681037|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
680992|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680993|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
680994|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680995|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
680996|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680997|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
680998|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
680999|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681000|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681001|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681002|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681003|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681004|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681035|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681036|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
724287|NCT01717989|O1|Outcome|December 2010|
681005|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681006|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681007|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681008|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681009|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681010|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681011|NCT01971723|O2|Outcome|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681012|NCT01971723|O1|Outcome|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681013|NCT01971723|E2|Reported Event|Placebo|"This arm requires the participants to take a prescribed dose of a calorie matched placebo for 4 weeks while completing an exercise regiment.~Placebo: The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group."
681014|NCT01971723|E1|Reported Event|T+ Supplement|"This arm requires the participants to take a prescribed dose of the T+ supplement for 4 weeks while completing an exercise regiment.~T+ Supplement: Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days)."
681015|NCT01971554|B5|Baseline|Total|Total of all reporting groups
681016|NCT01971554|B4|Baseline|Placebo|Placebo once daily for 14 consecutive days
681017|NCT01971554|B3|Baseline|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681018|NCT01971554|B2|Baseline|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681019|NCT01971554|B1|Baseline|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681020|NCT01971554|P4|Participant Flow|Placebo|Placebo once daily for 14 consecutive days
681021|NCT01971554|P3|Participant Flow|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681022|NCT01971554|P2|Participant Flow|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681023|NCT01971554|P1|Participant Flow|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681024|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
681025|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681026|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681027|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681028|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
681029|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681030|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681031|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681032|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
681038|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681039|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681040|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
681041|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681042|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681043|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681044|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
681045|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681046|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681047|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681048|NCT01971554|O4|Outcome|Placebo|Placebo once daily for 14 consecutive days
681049|NCT01971554|O3|Outcome|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681050|NCT01971554|O2|Outcome|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681051|NCT01971554|O1|Outcome|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681052|NCT01971554|E4|Reported Event|Placebo|Placebo once daily for 14 consecutive days
681053|NCT01971554|E3|Reported Event|MK-8666 500 mg|MK-8666 500 mg once daily for 14 consecutive days
681054|NCT01971554|E2|Reported Event|MK-8666 150 mg|MK-8666 150 mg once daily for 14 consecutive days
681055|NCT01971554|E1|Reported Event|MK-8666 50 mg|MK-8666 50 mg once daily for 14 consecutive days
681056|NCT01971255|B3|Baseline|Total|Total of all reporting groups
681057|NCT01971255|B2|Baseline|Low Titer (HAI < 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 at the time of planned inoculation and were placed in this group.
681058|NCT01971255|B1|Baseline|High Titer (HAI > 1:40)|Enrolled Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 at the time of planned inoculation were placed in this group.
681059|NCT01971255|P2|Participant Flow|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of <1:40 were assigned to this group.
681060|NCT01971255|P1|Participant Flow|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers at the time of challenge of =1:40 were assigned to this group.
681061|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
681062|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
681063|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
681064|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
681065|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
681066|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
681067|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
681068|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
681069|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
681070|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
681071|NCT01971255|O2|Outcome|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
681072|NCT01971255|O1|Outcome|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
681073|NCT01971255|E2|Reported Event|Low Titer (HAI < 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of <1:40 were assigned to this group.
681074|NCT01971255|E1|Reported Event|High Titer (HAI > 1:40)|Subjects with prechallenge hemagglutination inhibition (HAI) titers of =1:40 were assigned to this group.
681075|NCT01971086|B1|Baseline|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681076|NCT01971086|P1|Participant Flow|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681077|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681078|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681079|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681080|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681081|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681082|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
724288|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
683673|NCT01957579|O4|Outcome|12 mg/kg (FL)|FL patients in MEDI-551 12 mg/kg cohort
681083|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681084|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681085|NCT01971086|O1|Outcome|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs per nostril a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681086|NCT01971086|E1|Reported Event|Patients Treated With Rhinospray Plus|Patients with acute rhinitis treated with a maximum of 4 puffs a day of Rhinospray Plus nasal spray in a real life setting for up to 10 days.
681087|NCT01970995|B4|Baseline|Total|Total of all reporting groups
681088|NCT01970995|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681089|NCT01970995|B2|Baseline|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681090|NCT01970995|B1|Baseline|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681091|NCT01970995|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681092|NCT01970995|P2|Participant Flow|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681093|NCT01970995|P1|Participant Flow|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681094|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681095|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681096|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681097|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681098|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681099|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681100|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681101|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681102|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681103|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681104|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681105|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681106|NCT01970995|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681107|NCT01970995|O2|Outcome|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681108|NCT01970995|O1|Outcome|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681109|NCT01970995|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in a confinement setting and 85 days in an ambulatory setting
681110|NCT01970995|E2|Reported Event|Menthol Conventional Cigarette (mCC)|Ad libitum use of subject's own preferred brand of mCC for 5 days in a confinement setting and 85 days in an ambulatory setting
681111|NCT01970995|E1|Reported Event|THS 2.2 Menthol (mTHS 2.2)|Ad libitum use of THS 2.2 Menthol for 5 days in a confinement setting and 85 days in an ambulatory setting
681112|NCT01970982|B4|Baseline|Total|Total of all reporting groups
681113|NCT01970982|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
681114|NCT01970982|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
681115|NCT01970982|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
681116|NCT01970982|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
681117|NCT01970982|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
681118|NCT01970982|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
681119|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
681120|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
681121|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
681122|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
681123|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
681124|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
681125|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
681126|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
681127|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
681128|NCT01970982|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
681129|NCT01970982|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
681130|NCT01970982|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
681131|NCT01970982|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
681132|NCT01970982|E3|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
681133|NCT01970982|E2|Reported Event|Conventional Cigarette (CC)|Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement
681134|NCT01970982|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
681135|NCT01970878|B5|Baseline|Total|Total of all reporting groups
681136|NCT01970878|B4|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681137|NCT01970878|B3|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
681138|NCT01970878|B2|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg
681139|NCT01970878|B1|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681140|NCT01970878|P4|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681141|NCT01970878|P3|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
681142|NCT01970878|P2|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg
681143|NCT01970878|P1|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681144|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681145|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
681146|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
681147|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681148|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681149|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
681150|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
681151|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681152|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681153|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
681154|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
681155|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681156|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681157|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
681158|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
681159|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681160|NCT01970878|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681161|NCT01970878|O3|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
681162|NCT01970878|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg
681163|NCT01970878|O1|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681164|NCT01970878|E4|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
681165|NCT01970878|E3|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
681166|NCT01970878|E2|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg
681167|NCT01970878|E1|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg
681168|NCT01970787|B1|Baseline|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681169|NCT01970787|P1|Participant Flow|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681170|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681171|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681172|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681173|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681174|NCT01970787|O1|Outcome|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681175|NCT01970787|E1|Reported Event|RFA Treatment|"Assess the feasibility, safety, and efficacy of RF to the anal canal using the HALO Ablation System to eradicate anal HSIL lesions~Radiofrequency Ablation (RFA) using the HALO Ablation System"
681176|NCT01970488|B3|Baseline|Total|Total of all reporting groups
681177|NCT01970488|B2|Baseline|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681178|NCT01970488|B1|Baseline|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681179|NCT01970488|P5|Participant Flow|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681180|NCT01970488|P4|Participant Flow|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681756|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681181|NCT01970488|P3|Participant Flow|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681182|NCT01970488|P2|Participant Flow|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681183|NCT01970488|P1|Participant Flow|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681184|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681185|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681186|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681187|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681188|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681189|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681190|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681191|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681192|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681193|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681194|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681195|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681196|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681197|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681198|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681199|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681200|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681201|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681202|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681203|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681204|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681205|NCT01970488|O5|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681206|NCT01970488|O4|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681207|NCT01970488|O3|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681208|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681209|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681210|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681211|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681212|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681213|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681214|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681215|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681216|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681217|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681218|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681219|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681220|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681221|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681222|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681223|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681224|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681225|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681226|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681227|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681228|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681229|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681230|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681231|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681232|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681233|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681234|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681235|NCT01970488|O3|Outcome|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681236|NCT01970488|O2|Outcome|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681237|NCT01970488|O1|Outcome|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681238|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681239|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681240|NCT01970488|O2|Outcome|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681241|NCT01970488|O1|Outcome|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681242|NCT01970488|E5|Reported Event|Part 2: Adalimumab/ABP 501|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 were transitioned to receive 40 mg ABP 501 every 2 weeks until week 48.
681243|NCT01970488|E4|Reported Event|Part 2: Adalimumab/Adalimumab|Participants who received adalimumab in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg adalimumab every 2 weeks until week 48.
681244|NCT01970488|E3|Reported Event|Part 2: ABP 501/ABP 501|Participants who received ABP 501 in Part 1 with a PASI 50 response at week 16 continued to receive 40 mg ABP 501 every 2 weeks until week 48.
681245|NCT01970488|E2|Reported Event|Part 1: Adalimumab|Participants received 80 mg adalimumab subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681246|NCT01970488|E1|Reported Event|Part 1: ABP 501|Participants received 80 mg ABP 501 subcutaneously on week 1/day 1 (initial loading dose) and 40 mg at week 2 and every 2 weeks thereafter for 16 weeks.
681247|NCT01970475|B3|Baseline|Total|Total of all reporting groups
681248|NCT01970475|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681249|NCT01970475|B1|Baseline|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681757|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
681250|NCT01970475|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681251|NCT01970475|P1|Participant Flow|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681252|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681253|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681254|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681255|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681256|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681257|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681258|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681259|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681260|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681261|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681262|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681263|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681264|NCT01970475|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681265|NCT01970475|O1|Outcome|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681266|NCT01970475|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681267|NCT01970475|E1|Reported Event|ABP 501|Participants received ABP 501 40 mg subcutaneously on day 1 and every 2 weeks thereafter until week 22.
681268|NCT01970397|B3|Baseline|Total|Total of all reporting groups
681269|NCT01970397|B2|Baseline|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681270|NCT01970397|B1|Baseline|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681271|NCT01970397|P2|Participant Flow|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681272|NCT01970397|P1|Participant Flow|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681273|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681274|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681275|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681276|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681277|NCT01970397|O2|Outcome|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681278|NCT01970397|O1|Outcome|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681279|NCT01970397|E2|Reported Event|Belotero Balance®|Belotero Balance® injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681280|NCT01970397|E1|Reported Event|JUVEDERM® Ultra XC|JUVEDERM® Ultra XC injected into perioral lines (2.0 mLs for initial treatment on Day 1 and 1.0 mL for touch-up treatment 2 weeks later if applicable).
681281|NCT01969084|B3|Baseline|Total|Total of all reporting groups
681282|NCT01969084|B2|Baseline|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
681308|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681309|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681310|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
683670|NCT01957579|O3|Outcome|8 mg/kg (DLBCL)|DLBCL patients in MEDI-551 8 mg/kg cohort
681283|NCT01969084|B1|Baseline|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
681284|NCT01969084|P2|Participant Flow|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasod"
681285|NCT01969084|P1|Participant Flow|Linagliptin|"Subjects given Linagliptin~Linagliptin~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.~Macrocirculation testing: Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodila"
681286|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
681287|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
681288|NCT01969084|O2|Outcome|Sugar Pill|Subjects given sugar pill/placebo
681289|NCT01969084|O1|Outcome|Linagliptin|Subjects given Linagliptin
681290|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~Microcirculation testing: The endothelial function of the micro-circulation was assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity"
681291|NCT01969084|O1|Outcome|Linagliptin|Linagliptin treated group
681292|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
681293|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin~Linagliptin~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
681294|NCT01969084|O2|Outcome|Sugar Pill|"Subjects given sugar pill/placebo~Placebo~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
681295|NCT01969084|O1|Outcome|Linagliptin|"Subjects given Linagliptin~Linagliptin~MRI Scans: Phosphorus-31 MRI data was obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia."
681296|NCT01969084|E2|Reported Event|Sugar Pill|"Subjects given sugar pill/placebo~Placebo"
681297|NCT01969084|E1|Reported Event|Linagliptin|Subjects given Linagliptin
681298|NCT01968980|B3|Baseline|Total|Total of all reporting groups
681299|NCT01968980|B2|Baseline|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681300|NCT01968980|B1|Baseline|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681301|NCT01968980|P2|Participant Flow|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681302|NCT01968980|P1|Participant Flow|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681303|NCT01968980|O1|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681304|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681305|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681306|NCT01968980|O1|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681307|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681311|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681312|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681313|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681314|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681315|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681316|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681317|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681318|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681319|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681320|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681321|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681322|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681323|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681324|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681325|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681326|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681327|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681328|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681329|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681330|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681331|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681332|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681333|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681334|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681335|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681336|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681337|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681338|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681339|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681340|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681341|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681342|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681343|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681344|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681345|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681346|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681347|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681348|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681349|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681350|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681351|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681352|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681353|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681354|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681355|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681356|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681357|NCT01968980|O2|Outcome|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681358|NCT01968980|O1|Outcome|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681359|NCT01968980|E2|Reported Event|PF­-04950615|Participants received PF-04950615 150 milligram (mg) SC injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681360|NCT01968980|E1|Reported Event|Placebo|Participants received placebo matched to PF-04950615 subcutaneous (SC) injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681361|NCT01968954|B3|Baseline|Total|Total of all reporting groups
681362|NCT01968954|B2|Baseline|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681363|NCT01968954|B1|Baseline|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681364|NCT01968954|P2|Participant Flow|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681365|NCT01968954|P1|Participant Flow|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681366|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681367|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681368|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681369|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681370|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681371|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681372|NCT01968954|O1|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681373|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681374|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681375|NCT01968954|O1|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681376|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681377|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681758|NCT01966926|E2|Reported Event|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681378|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681379|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681380|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681381|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681382|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681383|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681384|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681385|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681386|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681387|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681388|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681389|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681390|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681391|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681392|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681393|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681394|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681395|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681396|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681397|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681398|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681399|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681400|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681401|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681402|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681403|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681404|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681405|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681406|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681407|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681408|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681409|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
724289|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
681410|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681411|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681412|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681413|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681414|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681415|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681416|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681417|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681418|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681419|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681420|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681421|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681422|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681423|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681424|NCT01968954|O2|Outcome|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681425|NCT01968954|O1|Outcome|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681426|NCT01968954|E2|Reported Event|PF-04950615 150 mg|Participants received single dose of PF-04950615 150 mg subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681427|NCT01968954|E1|Reported Event|Placebo|Participants received single dose of placebo matched to PF-04950615 subcutaneous injection once in every 2 weeks over a period of 52 weeks. Participants were followed up to 58 weeks.
681428|NCT01969747|B5|Baseline|Total|Total of all reporting groups
681429|NCT01969747|B4|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
681430|NCT01969747|B3|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
681431|NCT01969747|B2|Baseline|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
681432|NCT01969747|B1|Baseline|Placebo|Placebo tablet; oral administration once daily
681433|NCT01969747|P4|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
681434|NCT01969747|P3|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
681435|NCT01969747|P2|Participant Flow|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
681436|NCT01969747|P1|Participant Flow|Placebo|Placebo tablet; oral administration once daily
681437|NCT01969747|O4|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
681438|NCT01969747|O3|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
681439|NCT01969747|O2|Outcome|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
681440|NCT01969747|O1|Outcome|Placebo|Placebo tablet; oral administration once daily
681441|NCT01969747|E4|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg tablet; oral administration once daily
681442|NCT01969747|E3|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg tablet; oral administration once daily
681443|NCT01969747|E2|Reported Event|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet; oral administration once daily
681444|NCT01969747|E1|Reported Event|Placebo|Placebo tablet; oral administration once daily
681445|NCT01969721|B1|Baseline|Overall Study|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
681497|NCT01969162|B1|Baseline|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
724290|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
681446|NCT01969721|P4|Participant Flow|F+S 500/50 / F+S 250/50 / T+O 5/5 / T+O 2.5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
681447|NCT01969721|P3|Participant Flow|F+S 250/50 / T+O 2.5/5 / F+S 500/50 / T+O 5/5|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
681448|NCT01969721|P2|Participant Flow|T+O 5/5 / F+S 500/50 / T+O 2.5/5 / F+S 250/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled.~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo.~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo.~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
681449|NCT01969721|P1|Participant Flow|T+O 2.5/5 / T+O 5/5 / F+S 250/50 / F+S 500/50|"Patients received a total of four treatments. Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days. The treatments were orally inhaled .~Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 2.5/5).~Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg plus Fluticasone propionate+Salmeterol placebo (T+O 5/5).~Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 250/50).~Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg plus Tiotropium+Olodaterol placebo (F+S 500/50).~Tiotropium+Olodaterol FDC inhalation solutions were administered via the Respimat® inhaler once daily, Fluticasone propionate+Salmeterol FDC inhalation powders were administered orally twice daily via Accuhaler®."
681450|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681451|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681452|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681453|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681454|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681455|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681456|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681457|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681498|NCT01969162|P1|Participant Flow|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
681759|NCT01966926|E1|Reported Event|Daily Weight Tracking|daily weighing frequency instructions and tips
681458|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681459|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681460|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681461|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681462|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681463|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681464|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681465|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681466|NCT01969721|O4|Outcome|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681467|NCT01969721|O3|Outcome|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681468|NCT01969721|O2|Outcome|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681469|NCT01969721|O1|Outcome|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681470|NCT01969721|E4|Reported Event|F+S 500/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 500 μg and Salmeterol 50 μg (F+S 500/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681471|NCT01969721|E3|Reported Event|F+S 250/50 / T+O Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Fluticasone propionate 250 μg and Salmeterol 50 μg (F+S 250/50) administered orally twice daily via Accuhaler® plus Tiotropium+Olodaterol (T+O) placebo treatment administered orally once daily via the Respimat® inhaler."
681472|NCT01969721|E2|Reported Event|T+O 5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed dose combination (FDC) of Tiotropium 5 μg and Olodaterol 5 μg (T+O 5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681473|NCT01969721|E1|Reported Event|T+O 2.5/5 / F+S Placebo|"Treatments were taken for 6 weeks and each treatment period was separated by a washout period of at least 21 days.~• Fixed Dose Combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (T+O 2.5/5) administered orally via the Respimat® inhaler once daily plus Fluticasone propionate+Salmeterol (F+S) placebo treatment administered orally twice daily via Accuhaler®."
681474|NCT01969565|B1|Baseline|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
681542|NCT01968434|B3|Baseline|Total|Total of all reporting groups
724291|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
681475|NCT01969565|P1|Participant Flow|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
681476|NCT01969565|O1|Outcome|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
681477|NCT01969565|E1|Reported Event|Carfilzomib in Combination With Dexamethasone|"Carfilzomib will be administered at a dose of 20 mg/m2, with a dose escalation to 36 mg/m2 after Days 1 and 2 of Cycle 1 in level 1; and at a dose of 20 mg/m2, with a dose escalation to 45 mg/m2 after Days 1 and 2 of Cycle 1 in level 2 in subjects with multiple myeloma who are newly diagnosed and treatment naïve. Dexamethasone will be given as a fixed dose of 20 mg PO/IV (1, 2, 8, 9, 15, 16, 22, and 23) for cycles 1 to 4 and for subsequent cycles.~Carfilzomib~Dexamethasone"
681478|NCT01969539|B1|Baseline|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
681479|NCT01969539|P1|Participant Flow|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
681480|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
681481|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
681482|NCT01969539|O1|Outcome|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
681483|NCT01969539|E1|Reported Event|Combivent Respimat Via Trudell Adapter|Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
681484|NCT01969435|B1|Baseline|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681485|NCT01969435|P1|Participant Flow|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681486|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681487|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681488|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681489|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681490|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681491|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681492|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681493|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681494|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681495|NCT01969435|O1|Outcome|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
681496|NCT01969435|E1|Reported Event|Melphalan, Carmustine, Etoposide, Cytarabine (BEAM)|"Day -7, carmustine intravenous (IV) infusion~Days -6, -5, -4, and -3, etoposide and cytarabine (IV) infusions twice a day~Day -2, melphalan HCl (propylene glycol-free)(IV) infusion~Day 0, stem cell transplant."
724292|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
681499|NCT01969162|O1|Outcome|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
681500|NCT01969162|E1|Reported Event|All Participants|Adult volunteers without ocular disease who have tear samples collected as per protocol. No investigational drug is administered in this study.
681501|NCT01968811|B1|Baseline|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
681502|NCT01968811|P1|Participant Flow|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
681503|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
681504|NCT01968811|O1|Outcome|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
681505|NCT01968811|E1|Reported Event|Avance Foam, Abdominal Dressing Kit|Avance Foam dressing kit
681506|NCT01968694|B3|Baseline|Total|Total of all reporting groups
681507|NCT01968694|B2|Baseline|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.~IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
681508|NCT01968694|B1|Baseline|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.~IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
681509|NCT01968694|P2|Participant Flow|IV Diphenhydramine Then IV Lidocaine|"IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes.~IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes."
681510|NCT01968694|P1|Participant Flow|IV Lidocaine Then IV Diphenhydramine|"IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes.~IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes."
681511|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
681512|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
681513|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
681514|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
681515|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
681516|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
681517|NCT01968694|O2|Outcome|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
681518|NCT01968694|O1|Outcome|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
681519|NCT01968694|E4|Reported Event|Washout Period After IV Diphenhydramine|Washout period after IV diphenhydramine before IV Lidocaine
681520|NCT01968694|E3|Reported Event|Washout Period After IV Lidocaine|Washout period after IV Lidocaine before IV diphenhydramine
681521|NCT01968694|E2|Reported Event|IV Diphenhydramine|IV diphenhydramine 50mg total dosed as a 10mg IV bolus and then 40mg IV infusion over 30 minutes
681522|NCT01968694|E1|Reported Event|IV Lidocaine|IV lidocaine dosed at 8mg/kg IV (maximum 500 mg) and infused over 30 minutes
681523|NCT01968551|B4|Baseline|Total|Total of all reporting groups
681524|NCT01968551|B3|Baseline|Cohort 2: SBR|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks
681525|NCT01968551|B2|Baseline|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
681526|NCT01968551|B1|Baseline|Cohort 1|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
681527|NCT01968551|P3|Participant Flow|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
681528|NCT01968551|P2|Participant Flow|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
681529|NCT01968551|P1|Participant Flow|Cohort 1: E/C/F/TAF+DRV|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus Darunavir (DRV) (800 mg) tablet administered orally once daily for 48 weeks
681530|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
681531|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800mg) tablet administered orally once daily for 48 weeks
681532|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
681533|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
681534|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks with the option to switch to E/C/F/TAF in the extension phase.
681535|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
681536|NCT01968551|O2|Outcome|Cohort 2: Stay on Baseline Regimen (SBR)|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks.
681537|NCT01968551|O1|Outcome|Cohort 2: E/C/F/TAF+DRV|E/C/F/TDF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily for 48 weeks
681538|NCT01968551|E4|Reported Event|All E/C/F/TAF|All participants who received E/C/F/TAF during the Open-Label Phase or Extension Phase
681539|NCT01968551|E3|Reported Event|Cohort 2: SBR|Participants stayed on their baseline regimen administered according to the prescribing information for up to 48 weeks
681540|NCT01968551|E2|Reported Event|Cohort 2: E/C/F/TAF+DRV|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
681541|NCT01968551|E1|Reported Event|Cohort 1|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus DRV (800 mg) tablet administered orally once daily with food for 48 weeks
681543|NCT01968434|B2|Baseline|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
681544|NCT01968434|B1|Baseline|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum in a syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6.5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
681545|NCT01968434|P2|Participant Flow|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated carbocisteine syrup n = 72 received intervention n= 72 Lost to follow up n=6 Discontinued intervention n=0 Analyzed n=66 Excluded from analysis n=0"
681546|NCT01968434|P1|Participant Flow|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.~Access for eligibility= 195 Excluded =45 (refused to participate n= 24, not meeting inclusion criteria n=21) Enrolled: 150 completed pre-treatment questionnaire and randomized into groups Allocated protective syrup n = 78 received intervention n= 78 Lost to follow up n=3 Discontinued intervention n=0 Analyzed n=75 Excluded from analysis n=0"
681547|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
681548|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
681549|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
681550|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
681551|NCT01968434|O2|Outcome|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
681552|NCT01968434|O1|Outcome|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 20 ml divided in three doses per day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
681553|NCT01968434|E2|Reported Event|Carbocisteine Cough Syrup|"Dosage 20-25 mg/kg/day three times a day (3 days/4 nights)~carbocisteine cough syrup: Mucolytic"
681554|NCT01968434|E1|Reported Event|Protective Cough Syrup|"syrup containing honey, plantago lanceolata, grindelia robusta, helichrysum italicum ina syrup form. The cough syrup is a CE marked medical device acting in a non pharmacological way to reduce cough.~Dosage: 6,5 ml three times a day for the duration of the study (4 nights, 3 days)~protective cough syrup: The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration."
681555|NCT01968135|B3|Baseline|Total|Total of all reporting groups
681556|NCT01968135|B2|Baseline|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
681557|NCT01968135|B1|Baseline|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
681558|NCT01968135|P2|Participant Flow|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
681559|NCT01968135|P1|Participant Flow|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
681560|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
681561|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
681562|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
681563|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
681631|NCT01967719|P3|Participant Flow|mTHS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
681564|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
681565|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
681566|NCT01968135|O2|Outcome|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
681567|NCT01968135|O1|Outcome|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
681568|NCT01968135|E2|Reported Event|Combined Oral Contraceptive Pill|"150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill~Combined Oral Contraceptive Pill: 150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill"
681569|NCT01968135|E1|Reported Event|Sugar Pill|"Placebo Sugar Pill~Placebo Sugar Pill: Placebo Sugar Pill"
681570|NCT01968057|B1|Baseline|Baricitinib + Ciclosporin|"4 mg baricitinib administered orally on Day 1 of Period 1.~4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
681571|NCT01968057|P1|Participant Flow|Baricitinib + Ciclosporin|"4 milligrams (mg) baricitinib administered orally on Day 1 of Period 1.~4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2."
681572|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
681573|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
681574|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
681575|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
681576|NCT01968057|O2|Outcome|Baricitinib + Ciclosporin|4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.
681577|NCT01968057|O1|Outcome|Baricitinib|4 mg baricitinib administered orally on Day 1 of Period 1.
681578|NCT01968057|E2|Reported Event|Baricitinib + Ciclosporin|"4 mg baricitinib co-administered with 600 mg ciclosporin on Day 4 of Period 2.~Adverse events are reported from postdose on Day 4 up to Day 14."
681579|NCT01968057|E1|Reported Event|Baricitinib|"4 mg baricitinib administered orally on Day 1 of Period 1.~Adverse events are reported from baseline through predose on Day 4."
681580|NCT01967940|B4|Baseline|Total|Total of all reporting groups
681581|NCT01967940|B3|Baseline|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
681582|NCT01967940|B2|Baseline|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681583|NCT01967940|B1|Baseline|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681584|NCT01967940|P3|Participant Flow|Part 1 Randomized Cohort Placebo, Then Part 2 E/C/F/TAF+ATV|"Part 1: Placebo once daily + their current failing regimen for 10 days~Part 2: Following a 14-day washout period, participants received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks."
681585|NCT01967940|P2|Participant Flow|Part 1 Randomized Cohort TAF, Then Part 2 E/C/F/TAF+ATV|"Part 1: TAF 25 mg tablet once daily + their current failing regimen for 10 days~Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received E/C/F/TAF (150/150/200/10 mg) STR plus ATV 300 mg once daily for 48 weeks."
681586|NCT01967940|P1|Participant Flow|Part 1 Sentinel Cohort TAF, Then Part 2 E/C/F/TAF+ATV|"Part 1: Tenofovir alafenamide (TAF) 25 mg tablet once daily + their current failing regimen for 10 days~Part 2: Following a 14-day washout period, participants who had a > 0.5 log10 decline in HIV-1 RNA received elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) single-tablet regimen (STR) plus atazanavir (ATV) 300 mg once daily for 48 weeks."
681587|NCT01967940|O3|Outcome|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
681588|NCT01967940|O2|Outcome|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681589|NCT01967940|O1|Outcome|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681590|NCT01967940|O3|Outcome|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
681591|NCT01967940|O2|Outcome|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681592|NCT01967940|O1|Outcome|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681593|NCT01967940|E3|Reported Event|Part 1 Randomized Cohort Placebo|Placebo once daily + their current failing regimen for 10 days
681594|NCT01967940|E2|Reported Event|Part 1 Randomized Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681595|NCT01967940|E1|Reported Event|Part 1 Sentinel Cohort TAF|TAF 25 mg tablet once daily + their current failing regimen for 10 days
681596|NCT01967836|B1|Baseline|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering"
681597|NCT01967836|P1|Participant Flow|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
681598|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented~Nurses inspection of central line site on study participants at next clinic visit with return of subject patient questionnaire evaluation of use of product device with showing 27 nurse evaluations were completed for analysis"
681599|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented"
681600|NCT01967836|O1|Outcome|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering.~Subject specific characteristics 19 subjects in oncology clinic sites were approached to participate; 9 refused participation~1 subject in ambulatory clinic was approached and was consented"
681601|NCT01967836|E1|Reported Event|Glad Press 'n Seal|"Subjects will use Glad Press 'n Seal product as a moisture barrier to an IV line~Glad Press 'n Seal: Application of Glad Press n' Seal product as an IV site dressing protection during subject showering as a means of bathing"
681602|NCT01967784|B1|Baseline|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681603|NCT01967784|P1|Participant Flow|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681604|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681605|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681606|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681607|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681608|NCT01967784|O1|Outcome|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681609|NCT01967784|E1|Reported Event|Quadrivalent Influenza Vaccine|Participants aged 9 to 17 years of age who received one dose of the quadrivalent influenza vaccine (QIV) (split-virion, inactivated) Northern Hemisphere (NH) 2013-2014 formulation.
681610|NCT01967732|B3|Baseline|Total|Total of all reporting groups
681611|NCT01967732|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
681612|NCT01967732|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
681613|NCT01967732|P4|Participant Flow|NNS Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
681614|NCT01967732|P3|Participant Flow|THS 2.2 Then NNS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NNS)"
681615|NCT01967732|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
681616|NCT01967732|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
681617|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
681618|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
681619|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
681620|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
681621|NCT01967732|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
681622|NCT01967732|O3|Outcome|THS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
681623|NCT01967732|O2|Outcome|CC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
681624|NCT01967732|O1|Outcome|THS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
681625|NCT01967732|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NNS~Sequence NNS then THS 2.2"
681626|NCT01967732|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
681627|NCT01967719|B3|Baseline|Total|Total of all reporting groups
681628|NCT01967719|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
681629|NCT01967719|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
681630|NCT01967719|P4|Participant Flow|NNS Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NNS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
681710|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681632|NCT01967719|P2|Participant Flow|mCC Then mTHS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS 2.2)."
681633|NCT01967719|P1|Participant Flow|mTHS 2.2 Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
681634|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
681635|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
681636|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
681637|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2."
681638|NCT01967719|O4|Outcome|NNS - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
681639|NCT01967719|O3|Outcome|mTHS 2.2 - Group 2|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
681640|NCT01967719|O2|Outcome|mCC - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
681641|NCT01967719|O1|Outcome|mTHS 2.2 - Group 1|"The geometric least squares mean presented below takes into consideration the data of the subjects who were randomized in the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
681642|NCT01967719|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
681643|NCT01967719|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence mTHS 2.2 then NNS~Sequence NNS then mTHS 2.2"
681644|NCT01967719|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence mTHS 2.2 then mCC~Sequence mCC then mTHS 2.2"
681645|NCT01967706|B3|Baseline|Total|Total of all reporting groups
681646|NCT01967706|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
681647|NCT01967706|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
681648|NCT01967706|P4|Participant Flow|NRT Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
681649|NCT01967706|P3|Participant Flow|mTHS Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT)"
681650|NCT01967706|P2|Participant Flow|mCC Then mTHS|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mCC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mTHS)."
681651|NCT01967706|P1|Participant Flow|mTHS Then mCC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of mTHS)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of mCC)."
681652|NCT01967706|O2|Outcome|Ratio mTHS:NRT|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
681653|NCT01967706|O1|Outcome|Ratio mTHS:mCC|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS."
681654|NCT01967706|O2|Outcome|Ratio mTHS:NRT|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
681655|NCT01967706|O1|Outcome|Ratio mTHS:mCC|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
681656|NCT01967706|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the mTHS at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
681657|NCT01967706|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence mTHS then NRT~Sequence NRT then mTHS"
681658|NCT01967706|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence mTHS then mCC~Sequence mCC then mTHS"
681659|NCT01967550|B3|Baseline|Total|Total of all reporting groups
681660|NCT01967550|B2|Baseline|Placebo|Vehicle control
681661|NCT01967550|B1|Baseline|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
681662|NCT01967550|P2|Participant Flow|Placebo|Vehicle control
681663|NCT01967550|P1|Participant Flow|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
681664|NCT01967550|O2|Outcome|Placebo|Vehicle control
681665|NCT01967550|O1|Outcome|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
681666|NCT01967550|E2|Reported Event|Placebo|Vehicle control
681667|NCT01967550|E1|Reported Event|Diclofenac Diethylamine, DDEA 2.32% Gel|"diclofenac diethylamine, DDEA 2.32% gel~diclofenac diethylamine, DDEA 2.32% gel"
681668|NCT01967342|B4|Baseline|Total|Total of all reporting groups
681669|NCT01967342|B3|Baseline|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681670|NCT01967342|B2|Baseline|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681671|NCT01967342|B1|Baseline|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
681672|NCT01967342|P3|Participant Flow|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681673|NCT01967342|P2|Participant Flow|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681674|NCT01967342|P1|Participant Flow|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
681675|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681676|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681677|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
681678|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681679|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681680|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
681681|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681682|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681683|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
681709|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681754|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681684|NCT01967342|O3|Outcome|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681685|NCT01967342|O2|Outcome|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681686|NCT01967342|O1|Outcome|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
681687|NCT01967342|E3|Reported Event|Pain Ed|Pain Education: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681688|NCT01967342|E2|Reported Event|CBT for Pain|Cognitive-Behavioral Therapy for Pain: A 10-week psychosocial group treatment for chronic pain that focuses on providing core pain education and cognitive-behavior skills to low-income patients who may not have received this information due to existing barriers that often includes limited health literacy. In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system. Sessions occur once per week for a duration of 1.5 hours.
681689|NCT01967342|E1|Reported Event|Usual Care|Usual Care (Medical Treatment-as-Usual): A control/comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy.
681690|NCT01967277|B3|Baseline|Total|Total of all reporting groups
681691|NCT01967277|B2|Baseline|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
681692|NCT01967277|B1|Baseline|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
681693|NCT01967277|P2|Participant Flow|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
681694|NCT01967277|P1|Participant Flow|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
681695|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
681696|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
681697|NCT01967277|O2|Outcome|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
681698|NCT01967277|O1|Outcome|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
681699|NCT01967277|E2|Reported Event|Handi-Dome Laser|"Active Device: Study subjects self-administer actual laser treatments, at home, every other day, for 16 weeks.~Handi-Dome Laser: One, 30 minute treatment, every other day for 16 weeks."
681700|NCT01967277|E1|Reported Event|Incandescent Red Light Source|"Placebo: A red, incandescent light source replaces all laser output. The treatment sessions are self-administered at home, every other day, for 16 weeks.~Incandescent red light source.: One, 30 minute treatment, every other day for 16 weeks."
681701|NCT01967147|B3|Baseline|Total|Total of all reporting groups
681702|NCT01967147|B2|Baseline|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681703|NCT01967147|B1|Baseline|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681704|NCT01967147|P2|Participant Flow|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681705|NCT01967147|P1|Participant Flow|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681706|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681707|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681708|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681755|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
681711|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681712|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681713|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681714|NCT01967147|O2|Outcome|Saline|Saline solution, 1 drop in each eye, 4 times/day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681715|NCT01967147|O1|Outcome|Systane Balance|Propylene Glycol, 1 drop in each eye, 4 times per day, during Phase I, followed by 1 drop in each eye as needed during Phase II
681716|NCT01967147|E3|Reported Event|Saline|All subjects exposed to Saline
681717|NCT01967147|E2|Reported Event|Systane Balance|All subjects exposed to Systane® Balance
681718|NCT01967147|E1|Reported Event|Pretreatment|All subjects prior to exposure to investigational product
681719|NCT01967121|B4|Baseline|Total|Total of all reporting groups
681720|NCT01967121|B3|Baseline|Control|This is a control group where subjects will not perform an intervention.
681721|NCT01967121|B2|Baseline|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
681722|NCT01967121|B1|Baseline|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
681723|NCT01967121|P3|Participant Flow|Control|This is a control group where subjects will not perform an intervention.
681724|NCT01967121|P2|Participant Flow|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
681725|NCT01967121|P1|Participant Flow|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
681726|NCT01967121|O3|Outcome|Control|This is a control group where subjects will not perform an intervention.
681727|NCT01967121|O2|Outcome|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
681728|NCT01967121|O1|Outcome|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
681729|NCT01967121|E3|Reported Event|Control|This is a control group where subjects will not perform an intervention.
681730|NCT01967121|E2|Reported Event|Ice Application|"A randomized pre and post-test research design will be used to compare three interventions (control, ice, compex) to alleviate the physical symptoms of delayed-onset muscle soreness (DOMS).~Ice application: Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present"
681731|NCT01967121|E1|Reported Event|'Compex Unit's Active Recovery® Program'|"The Compex electrical stimulation system utilized in this study is intended for external application with electrodes to create a muscular contraction and help enhance recovery after eccentric muscular activity.~Compex unit's Active Recovery® program: Compex unit's Active Recovery® program will be performed for 15 minutes once per day."
681732|NCT01967069|B3|Baseline|Total|Total of all reporting groups
681733|NCT01967069|B2|Baseline|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
681734|NCT01967069|B1|Baseline|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
681735|NCT01967069|P2|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
681736|NCT01967069|P1|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
681737|NCT01967069|O2|Outcome|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
681738|NCT01967069|O1|Outcome|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
681739|NCT01967069|E2|Reported Event|Vehicle Spray|"Vehicle Spray twice daily~Vehicle Spray"
681740|NCT01967069|E1|Reported Event|DFD01 Spray|"DFD01 Spray twice daily~DFD01 Spray"
681741|NCT01966926|B3|Baseline|Total|Total of all reporting groups
681742|NCT01966926|B2|Baseline|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681743|NCT01966926|B1|Baseline|Daily Weight Tracking|daily weighing frequency instructions and tips
681744|NCT01966926|P2|Participant Flow|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681745|NCT01966926|P1|Participant Flow|Daily Weight Tracking|daily weighing frequency instructions and tips
681746|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681747|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
681748|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681749|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
681750|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681751|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
681752|NCT01966926|O2|Outcome|Weekly Weight Tracking|weekly weighing frequency instructions and tips
681753|NCT01966926|O1|Outcome|Daily Weight Tracking|daily weighing frequency instructions and tips
681760|NCT01966770|B1|Baseline|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
681761|NCT01966770|P1|Participant Flow|Overall Study Group|All participants were habitual contact lens wearers and all participants wore Day 1 followed by Day 2 lenses
681762|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681763|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681764|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681765|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681766|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681767|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681768|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681769|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681770|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681771|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681772|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681773|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681774|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681775|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681776|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681777|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
681778|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
681779|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681780|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681781|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681782|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681783|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681784|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681785|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681786|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681787|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681788|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681789|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681790|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681791|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681792|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681793|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681794|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681795|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681796|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681797|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681798|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681799|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681800|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681801|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681802|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681803|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681804|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681805|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681806|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681807|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681808|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681809|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681810|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681811|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681812|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681813|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681814|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681815|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681816|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
681817|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
681818|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
681819|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681820|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681821|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681822|NCT01966770|O1|Outcome|PCM SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681823|NCT01966770|O1|Outcome|F55 SPHERE LENS P2 / BIOFINITY LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681824|NCT01966770|O1|Outcome|F55 SPHERE LENS P1 / F55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681825|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
681826|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
681827|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681828|NCT01966770|O1|Outcome|B55 SPHERE LENS P3 / BF SPHERE LENS P3|Subjects wore contralateral lenses. Pair 3 Biomedics 55 Sphere (B55 SPHERE LENS P3) in one eye and Biofinity (BF SPHERE LENS P3) in the other.
681829|NCT01966770|O1|Outcome|B55 SPHERE LENS P2 / AV SPHERE LENS P2|Subjects wore contralateral lenses. Pair 2 Biomedics 55 Sphere (B55 SPHERE LENS P2) in one eye and Avairia sphere (AV SPHERE LENS P2) in the other.
681830|NCT01966770|O1|Outcome|B55 SPHERE LENS P1 / B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Pair 1 Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681831|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681832|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
682040|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
681833|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681834|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681835|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681836|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681837|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681838|NCT01966770|O5|Outcome|PCM SPHERE LENS P3|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681839|NCT01966770|O4|Outcome|BF SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681840|NCT01966770|O3|Outcome|F55 SPHERE LENS P2|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681841|NCT01966770|O2|Outcome|F55 ASPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681842|NCT01966770|O1|Outcome|F55 SPHERE LENS P1|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and Frequency 55 Asphere (F55 ASPHERE LENS) in the other.
681843|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681844|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681845|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681846|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681847|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681848|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681849|NCT01966770|O6|Outcome|BF SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681850|NCT01966770|O5|Outcome|B55 SPHERE LENS P3|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other.
681851|NCT01966770|O4|Outcome|AV SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681852|NCT01966770|O3|Outcome|B55 SPHERE LENS P2|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Avaira (AV SPHERE LENS) in the other.
681853|NCT01966770|O2|Outcome|B55 PREMIER ASPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681854|NCT01966770|O1|Outcome|B55 SPHERE LENS P1|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in the other.
681855|NCT01966770|O7|Outcome|F55 ASPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Asphere (F55 ASPHERE LENS) in one eye and Frequency 55 Sphere (F55 SPHERE LENS) in the other.
681856|NCT01966770|O6|Outcome|F55 SPHERE LENS|Subjects wore contralateral lenses. Frequency 55 Sphere (F55 SPHERE LENS) in one eye and either Frequency 55 Asphere (F55 ASPHERE LENS) or Biofinity (BF SPHERE LENS) in the other.
681857|NCT01966770|O5|Outcome|PCM SPHERE LENS|Subjects wore contralateral lenses. Proclear Monthly (PCM SPHERE LENS) in one eye and Biofinity (BF SPHERE LENS) in the other. Collected at study lens dispense.
681858|NCT01966770|O4|Outcome|AV SPHERE LENS|Subjects wore contralateral lenses. Avaira (AV SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
681859|NCT01966770|O3|Outcome|BF SPHERE LENS|Subjects wore contralateral lenses. Biofinity (BF SPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
681860|NCT01966770|O2|Outcome|B55 SPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Sphere (B55 SPHERE LENS) in one eye and either Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) or Biofinity (BF SPHERE LENS) or Avaira (AV SPHERE LENS) in the other.
681861|NCT01966770|O1|Outcome|B55 PREMIER ASPHERE LENS|Subjects wore contralateral lenses. Biomedics 55 Asphere (B55 PREMIER ASPHERE LENS) in one eye and Biomedics 55 Sphere (B55 SPHERE LENS) in the other.
681862|NCT01966770|O1|Outcome|Habitual Lens|Subjects presented wearing habitual lenses prior to dispense of study lenses.
681863|NCT01966770|E6|Reported Event|Pair 6 (Omafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
681864|NCT01966770|E5|Reported Event|Pair 5 (Methafilcon A / Comfilcon A)|Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
681865|NCT01966770|E4|Reported Event|Pair 4 (Methafilcon A / Methafilcon A)|Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
681866|NCT01966770|E3|Reported Event|Pair 3 (Ocufilcon D / Comfilcon A)|Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
681867|NCT01966770|E2|Reported Event|Pair 2 (Ocufilcon D / Enfilcon A)|Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
681868|NCT01966770|E1|Reported Event|Pair 1 (Ocufilcon D / Ocufilcon D)|Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
681916|NCT01966159|P1|Participant Flow|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
681917|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
681869|NCT01966718|B1|Baseline|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
681870|NCT01966718|P1|Participant Flow|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
681871|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
681872|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
681873|NCT01966718|O1|Outcome|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
681874|NCT01966718|O2|Outcome|Tender Joints|Change in number of tender joints exhibited at week 16, calculated by subtracting week 16 total from baseline total.
681875|NCT01966718|O1|Outcome|Swollen Joints|Change in number of swollen joints participants exhibited at week 16 (Calculated by subtracting week 16 total from baseline total. Positive numbers indicate number at week 16 was less than at baseline).
681876|NCT01966718|E1|Reported Event|Repository Corticotropin Injection|"Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks~Repository corticotropin injection: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances"
681877|NCT01966380|B1|Baseline|Leia and Hydroactive Surgical Dressing|In the case of this study, participants served as their own control.
681878|NCT01966380|P2|Participant Flow|Cross-over Assignment Hydroactive Surgical Dressing|First intervention Hydroactive surgical dressing 5 Days, then second intervention Leia, 5 Days..
681879|NCT01966380|P1|Participant Flow|Cross-over Assignment Leia|First intervention Leia, 5 Days, then second intervention Hydroactive surgical dressing 5 Days.
681880|NCT01966380|O2|Outcome|Hydroactivate Surgical Dressing|Intervention: Device, Hydroactivate surgical dressing. Cross-over design, the patient was his own controll. 6 patients were treated in total.
681881|NCT01966380|O1|Outcome|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
681882|NCT01966380|E2|Reported Event|Hydroactive Surgical Dressing|"Intervention: Device: Hydroactive surgical dressing~Cross-over design, the patient was his own controll. 6 patients were treated in total."
681883|NCT01966380|E1|Reported Event|Leia|Intervention: Device, Leia dressing Cross-over design, the patient was his own controll. 6 patients were treated in total.
681884|NCT01966354|B4|Baseline|Total|Total of all reporting groups
681885|NCT01966354|B3|Baseline|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681886|NCT01966354|B2|Baseline|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681887|NCT01966354|B1|Baseline|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681918|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
681919|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
683671|NCT01957579|O2|Outcome|4 mg/kg (DLBCL)|DLBCL patients in MEDI-551 4 mg/kg cohort
681888|NCT01966354|P3|Participant Flow|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681889|NCT01966354|P2|Participant Flow|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681890|NCT01966354|P1|Participant Flow|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681891|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681892|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681893|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681894|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681895|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681920|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
681921|NCT01966159|O2|Outcome|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
681922|NCT01966159|O1|Outcome|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
683672|NCT01957579|O1|Outcome|2 mg/kg (DLBCL)|DLBCL patients in MEDI-551 2 mg/kg cohort
681896|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681897|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681898|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681899|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681900|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681901|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681902|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681903|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681923|NCT01966159|E2|Reported Event|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
681924|NCT01966159|E1|Reported Event|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
681925|NCT01966120|B3|Baseline|Total|Total of all reporting groups
682041|NCT01965652|E2|Reported Event|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
724293|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
681904|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681905|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681906|NCT01966354|O3|Outcome|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681907|NCT01966354|O2|Outcome|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681908|NCT01966354|O1|Outcome|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681909|NCT01966354|E3|Reported Event|Oblique Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Oblique axis, in-plane needle:~Jugular vein is ultrasonographically visualized in an oblique axis (intermediate view between long and short axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681910|NCT01966354|E2|Reported Event|Short Axis, Out-of-plane Needle|"Ultrasound-guided Internal jugular venous approach~Short axis, out-of-plane needle:~Jugular vein is ultrasonographically visualized in a transverse fashion (short axis) and the needle is inserted perpendicular to the longitudinal axis of the transducer (out-of-plane).~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681911|NCT01966354|E1|Reported Event|Long Axis, In-plane Needle|"Ultrasound-guided Internal jugular venous approach~Long axis, in-plane needle:~Jugular vein is ultrasonographically visualized in a longitudinal fashion (long axis) and the needle is inserted in the same ultrasound plane, aligned with the longitudinal axis of the transducer.~Ultrasound-guided Internal jugular venous approach: The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
681912|NCT01966159|B3|Baseline|Total|Total of all reporting groups
681913|NCT01966159|B2|Baseline|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
681914|NCT01966159|B1|Baseline|SYNERGY Investigational Device (Test)|SYNERGY Investigational Device (Test): percutaneous coronary intervention
681915|NCT01966159|P2|Participant Flow|PROMUS Element Plus Investigational Device (Control)|PROMUS Element Plus Investigational Device (Control): percutaneous coronary intervention
681926|NCT01966120|B2|Baseline|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681927|NCT01966120|B1|Baseline|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681928|NCT01966120|P2|Participant Flow|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681929|NCT01966120|P1|Participant Flow|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the investigational medicinal product (IMP) was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681930|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681931|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681932|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681933|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681952|NCT01966068|B1|Baseline|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
681934|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681935|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681936|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681937|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681938|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681939|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681940|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681941|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
682042|NCT01965652|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682574|NCT01964352|P1|Participant Flow|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
681942|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681943|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681944|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681945|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681946|NCT01966120|O2|Outcome|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681947|NCT01966120|O1|Outcome|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681948|NCT01966120|E2|Reported Event|Placebo to BF-200 ALA|"Photodynamic therapy with a nanoemulsion gel formulation similar to BF-200 ALA, but without the active ingredient 5-aminolevulinic acid.~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681949|NCT01966120|E1|Reported Event|BF-200 ALA|"Photodynamic therapy with BF-200 ALA~After lesion preparation, the entire content of 1 tube of verum was applied to the treatment fields identified for this study at screening. The verum was applied to the entire field(s) covering a size of approx. 20 cm² with a film of about 1 mm thickness. Application near the eyes, nostrils, mouth, ears, or mucosa was to be avoided (by a distance of 1 cm). After application, the IMP was allowed to dry for approx. 10 minutes before occlusion.~Following incubation of 3 hours (+/- 10 minutes) the dressing was removed and the remnant gel wiped off with a 0.9% saline solution. Thereafter illumination was performed using BF-RhodoLED lamp (635 nm) applying a total light dose of 37 J/cm² (per treated field). This treatment was performed once and repeated after 12 weeks if no complete response was observed."
681950|NCT01966068|B3|Baseline|Total|Total of all reporting groups
681951|NCT01966068|B2|Baseline|MyAsthma Web Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once
681953|NCT01966068|P1|Participant Flow|MyAsthma Web Portal|The portal, MyAsthma, provided asthma education, collected patient-reported outcomes, evaluated medication use and side effects, and tracked parents' concerns and goals. Parents logged into the web portal each month, and the information entered by parents was shared through the electronic health record with the child's primary care provider.
681954|NCT01966068|O2|Outcome|MyAsthma Portal Adoption|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys only once.
681955|NCT01966068|O1|Outcome|MyAsthma Web Portal Sustained Use|Subject (parent/guardian) logged on to the MyAsthma Web Portal and completed surveys more than once
681956|NCT01966068|E1|Reported Event|MyAsthma Web Portal|"The portal, MyAsthma, will provide asthma education, collect patient-reported outcomes, evaluate medication use and side effects, and track parents' concerns and goals. Parents will log into the web portal each month, and the information entered by parents will be shared through the electronic health record with the child's primary care provider.~MyAsthma Web Portal"
681957|NCT01966042|B1|Baseline|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
681958|NCT01966042|P1|Participant Flow|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and autologous bone marrow mononuclear cells infusion.~Local sedation: All subjects enrolled underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled underwent bone marrow aspiration after anesthesia from the posterior iliac crest. The sample was aspirated into sterile syringes and brought to the cell processing laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened, the surgeon drew up the cells into syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
681959|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
681960|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
681961|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
681962|NCT01966042|O1|Outcome|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
681982|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
724294|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
681963|NCT01966042|E1|Reported Event|Cell Therapy|"All subjects enrolled in the study underwent bone marrow aspiration and infusion of autologous bone marrow mononuclear cells.~Local sedation: All subjects enrolled in the study underwent local sedation for bone marrow aspiration.~Bone Marrow Aspiration: All subjects enrolled in the study underwent bone marrow aspiration after anesthesia.~Minithoracotomy: The cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.~Autologous bone marrow mononuclear cells infusion: Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium."
681964|NCT01965938|B3|Baseline|Total|Total of all reporting groups
681965|NCT01965938|B2|Baseline|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681966|NCT01965938|B1|Baseline|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681967|NCT01965938|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681968|NCT01965938|P1|Participant Flow|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681969|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
681970|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
681971|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681972|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681973|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681974|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681975|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681976|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681977|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681978|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681979|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
681980|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|"Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
681981|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|"Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.~Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed."
681983|NCT01965938|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681984|NCT01965938|O1|Outcome|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681985|NCT01965938|E2|Reported Event|Fiberoptic Bronchoscope|Fiberoptic Bronchoscope: Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681986|NCT01965938|E1|Reported Event|RIFL (Rigid and Flexing Laryngoscope)|RIFL (Rigid and Flexing Laryngoscope): Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
681987|NCT01965899|B1|Baseline|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681988|NCT01965899|P1|Participant Flow|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681989|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681990|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681991|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from the automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681992|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681993|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681994|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681995|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681996|NCT01965899|O1|Outcome|Insertable Cardiac Monitor Implant|Insertable Cardiac Monitor Implant: The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient’s subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681997|NCT01965899|E1|Reported Event|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
681998|NCT01965834|B1|Baseline|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
681999|NCT01965834|P1|Participant Flow|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
682000|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
682001|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
682002|NCT01965834|O1|Outcome|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
682003|NCT01965834|E1|Reported Event|Fenofibrate Therapy|"Fenofibrate orally daily for each 28 day cycle, per study protocol.~Fenofibrate: Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily."
682004|NCT01965665|B1|Baseline|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
682005|NCT01965665|P1|Participant Flow|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
682006|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
682007|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
682008|NCT01965665|O1|Outcome|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
682009|NCT01965665|E1|Reported Event|Medihoney HCS Dressing|"weekly Medihoney pin site care until frame removal. Standard size dressings and application technique will be used at each pin site with prefabricated materials.~MediHoney HCS dressing"
682010|NCT01965652|B3|Baseline|Total|Total of all reporting groups
682011|NCT01965652|B2|Baseline|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682012|NCT01965652|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682013|NCT01965652|P2|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682014|NCT01965652|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682015|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682016|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682017|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682018|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682019|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682020|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682021|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682022|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682023|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682024|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682025|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682026|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682027|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682028|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682029|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682030|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682031|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682032|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682033|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682034|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682035|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682036|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682037|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
682038|NCT01965652|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine tablets orally once daily for 52 weeks.
682039|NCT01965652|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 52 weeks.
724295|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
682043|NCT01965600|B1|Baseline|All Participants|Participants received PF-06282999 125 mg TID or 500 mg BID or matching placebo orally in tablet form from Days 1 to 3. On Day 3, participants received a dose of LPS as an IV bolus at a dose of 4 ng/kg over 45-60 secs 2 hours after the morning dose of PF-06282999 or matching placebo. A final dose of PF-06282999 or matching placebo was administered on the evening of Day 3. Period 2 started after a washout period of approximately 15 days with at least 21 days in between administration of LPS. Participants who took active treatment (PF-06282999) in Period 1 received placebo in Period 2 and vice versa.
682044|NCT01965600|P4|Participant Flow|Placebo Followed by PF-06282999 500 mg BID|Participants received placebo orally via tablets. Placebo matching PF-06282999 500 mg BID were administered on Days 1-3 at 8am and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 500 mg BID in the same manner as placebo in the first period.
682045|NCT01965600|P3|Participant Flow|PF-06282999 500 mg BID Followed by Placebo|Participants received PF-06282999 500 milligrams (mg) twice daily (BID) orally in tablet form from Days 1 to 3 (8am and 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
682046|NCT01965600|P2|Participant Flow|Placebo Followed by PF-06282999 125 mg TID|Participants received placebo orally via tablets. Placebo matching PF-06282999 125 mg TID were administered on Days 1-3 at approximately 8am, 2pm, and 8pm. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3. Following a washout of about 15 days, participants returned for the second period where they received PF-06282999 125 mg TID in the same manner as placebo in the first period.
682047|NCT01965600|P1|Participant Flow|PF-06282999 125 mg TID Followed by Placebo|Participants received PF-06282999 125 milligrams (mg) three times daily (TID) orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm). On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3. After about 15 days of washout, participants returned for the second period where they received placebo in the same manner as active treatment before.
682048|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682049|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682050|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682051|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682052|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682053|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682054|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682055|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682056|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682357|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
724296|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
682057|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682058|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682059|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682060|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682061|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682062|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682063|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682064|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682065|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682066|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682067|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682068|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682069|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682070|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682071|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682072|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682073|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682074|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682075|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682076|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682077|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682078|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682079|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682080|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682081|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682082|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682083|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682084|NCT01965600|O3|Outcome|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682085|NCT01965600|O2|Outcome|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
682086|NCT01965600|O1|Outcome|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682087|NCT01965600|E3|Reported Event|PF-06282999 500 mg BID|All participants who received PF-06282999 500 mg BID orally in tablet form from Days 1 to 3 (8am and 8pm) in either Periods 1 or 2 are pooled in 1 group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 ng/kg over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. A final dose of PF-06282999 500 mg was administered on the evening of Day 3.
682088|NCT01965600|E2|Reported Event|Placebo|All participants who received placebo in either Periods 1 or 2 are pooled in 1 group. Placebo matching either PF-06282999 125 mg TID or 500 mg twice daily (BID) were administered on Days 1-3 of each period. 2 hours after the morning dose on Day 3, LPS as IV bolus at a dose of 4 ng/kg over 45-60 secs was administered. The final dose of placebo was administered on the evening of Day 3.
724297|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
682089|NCT01965600|E1|Reported Event|PF-06282999 125 mg TID|All participants who received PF-06282999 125 mg TID orally in tablet form from Days 1 to 3 (approximately 8am, 2pm, 8pm) in either Periods 1 or 2 are pooled in one group. On Day 3, participants received a dose of lipopolysaccharide (LPS) as an intravenous (IV) bolus at a dose of 4 nanogram (ng)/kilogram (kg) over 45-60 seconds (secs) 2 hours after the morning dose of PF-06282999. The final dose of PF-06282999 125 mg was administered on the evening of Day 3.
682090|NCT01965561|B1|Baseline|Junctional Tourniquet Use|"Junctional tourniquet use followed by rest, repeat~Rest = 5 minutes. SJT is belt with discs that inflate. JETT is belt with pads that screw down. AAT is an bladder within a belt. CRC is a vice."
682091|NCT01965561|P1|Participant Flow|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
682092|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
682093|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
682094|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
682095|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
682096|NCT01965561|O4|Outcome|SJT Tourniquet|SAM Junctional Tourniquet (SJT)
682097|NCT01965561|O3|Outcome|JETT|Use of Junctional Emergency Treatment Tool (JETT)
682098|NCT01965561|O2|Outcome|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
682099|NCT01965561|O1|Outcome|CRoC|Use of Combat Ready Clamp (CRoC)
682100|NCT01965561|E1|Reported Event|Junctional Tourniquet Use|Junctional tourniquet use followed by rest, repeat.
682101|NCT01965535|B3|Baseline|Total|Total of all reporting groups
682102|NCT01965535|B2|Baseline|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682103|NCT01965535|B1|Baseline|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
682104|NCT01965535|P2|Participant Flow|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682105|NCT01965535|P1|Participant Flow|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus placebo to match ribavirin (RBV) in a divided daily dose for 24 weeks
682106|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682107|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
682108|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682109|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
682110|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682111|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
682112|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682113|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
682114|NCT01965535|O2|Outcome|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682115|NCT01965535|O1|Outcome|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
682116|NCT01965535|E2|Reported Event|LDV/SOF + RBV|Placebo to match LDV/SOF plus placebo to match RBV for 12 weeks, followed by LDV/SOF (90/400 mg) FDC tablet plus RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg) for 12 weeks
682117|NCT01965535|E1|Reported Event|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet once daily plus placebo to match RBV in a divided daily dose for 24 weeks
682118|NCT01965431|B1|Baseline|Overall Study|This study is randomised, single-blind, 3-period crossover having 3 treatments, BI 207127 and Faldaprevir for 3 days (Days -2 to 1), placebo to BI 207127 plus placebo to Faldaprevir for 3 days (Days -2 to 1) and Moxifloxacin 400 mg as single dose (Day 1).
682119|NCT01965431|P6|Participant Flow|R2/R1/T|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
724298|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
682120|NCT01965431|P5|Participant Flow|R2/T/R1|Patients were treated in the morning with oral dose, started in period 1 with Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered on as single dose on day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
682121|NCT01965431|P4|Participant Flow|R1/R2/T|Patients were treated in the morning with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
682122|NCT01965431|P3|Participant Flow|R1/T/R2|Patients were treated with oral dose, started in period 1 with matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, followed in period 2 by BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2):Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
682123|NCT01965431|P2|Participant Flow|T/R2/R1|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) bid were administered on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water, followed in period 2 by Moxifloxacin (R2): Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water, and in period 3 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
682124|NCT01965431|P1|Participant Flow|T/R1/R2|Patients were treated with oral dose, started in period 1 with BI 207127 plus Faldaprevir (T) for three days (day -2, -1 and 1): BI 207127 film coated tablets 600 mg (3x200 mg) twice daily (bid) were administered on day -2 and day -1 and 600 mg once daily (qd) on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg once daily (qd) on day -1 and day 1 with 240 mL of water, followed in period 2 by matching placebos (R1) for three days (day -2, -1 and 1): matching placebo (BI 207127) three tablets, twice daily (bid) were administered on day -2 and day -1 and three tablets, once daily (qd) on day 1, plus matching placebo (Faldaprevir) soft gelatin two capsules qd on day -2 and one capsule qd on day -1 and day 1 with 240 mL of water, and in period 3 by Moxifloxacin (R2) : Moxifloxacin film coated tablet 400 mg was administered as single dose on day 1 with 240 mL of water. Treatment periods were separated by a wash-out phase of at least 8 days.
682125|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
682126|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
682127|NCT01965431|O2|Outcome|Placebo to BI 207127) + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
682128|NCT01965431|O1|Outcome|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
682129|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
682130|NCT01965431|O1|Outcome|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day 1 with 240 mL of water.
682131|NCT01965431|O2|Outcome|Placebo to BI 207127 + Placebo to Faldaprevir|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
682132|NCT01965431|O1|Outcome|BI 207127+ Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and day 1 with 240 mL of water.
682153|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682133|NCT01965431|E3|Reported Event|Placebo (BI 207127) + Placebo (Faldaprevir)|Orally administered matching placebo (BI 207127) tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus matching placebo (Faldaprevir) soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
682134|NCT01965431|E2|Reported Event|Moxifloxacin|Orally administered Moxifloxacin film coated tablet 400 mg as single dose on day1 with 240 mL of water.
682135|NCT01965431|E1|Reported Event|BI 207127 + Faldaprevir|Orally administered BI 207127 film coated tablets 600 mg (3x200 mg) bid on day -2 and day -1 and 600 mg qd on day 1 plus Faldaprevir soft gelatin capsules 240 mg (2x120 mg) on day -2 and 120 mg qd on day -1 and 1 with 240 mL of water.
682136|NCT01965327|B1|Baseline|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
682137|NCT01965327|P1|Participant Flow|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
682138|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
682139|NCT01965327|O1|Outcome|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
682140|NCT01965327|E1|Reported Event|Interferon Gamma-1b (ACTIMMUNE)|All individuals in this study were treated with interferon gamma-1b (ACTIMMUNE). Doses were administered via subcutaneous injections three times per week for 12 weeks. Dose-escalation schedule was completed by all subjects as follows: For the first two weeks subjects took10 mcg/m2 of interferon gamma-1b (IFN-g-1b), then the dose was escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study, finally, the dose was escalated to 50 mcg/m2 of IFN-gamma-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
682141|NCT01965288|B3|Baseline|Total|Total of all reporting groups
682142|NCT01965288|B2|Baseline|Lotrafilcon B Then Comfilcon A|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682143|NCT01965288|B1|Baseline|Comfilcon A Then Lotrafilcon B|All subjects attended first visit with habitual lenses and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682144|NCT01965288|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682145|NCT01965288|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682146|NCT01965288|O3|Outcome|Neither|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682147|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682148|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682149|NCT01965288|O3|Outcome|Habitual|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682150|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682151|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682152|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682154|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682155|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682156|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682157|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682158|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682159|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682160|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682161|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682162|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682163|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682164|NCT01965288|O2|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682165|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682166|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682167|NCT01965288|O1|Outcome|Habitual Lenses|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682168|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682169|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682170|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682171|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682172|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
682173|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682174|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682175|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682176|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682177|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682575|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682178|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682179|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682180|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682181|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682182|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682183|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682184|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682185|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
682186|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682187|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682188|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682189|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682190|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
682191|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682192|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682193|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682194|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682195|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
682196|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682197|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682198|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682199|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682200|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects with habitual lens prior to dispense of study lens.
682201|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682202|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682203|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682204|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682205|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682206|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682207|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682208|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682209|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682210|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682211|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682212|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682213|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682214|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682215|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682216|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682217|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682218|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682219|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682220|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682221|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682222|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682223|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682224|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682225|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682226|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682227|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682228|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682229|NCT01965288|O2|Outcome|Lotrafilcon B|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
682230|NCT01965288|O1|Outcome|Comfilcon A|Each subject randomized to wear comfilcon A or lotrafilcon B for one month of daily wear before repeating the schedule for the second pair without a washout period. All subjects wore both lenses. (comfilcon A then lotrafilcon B and/or lotrafilcon B then comfilcon A)
682231|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682232|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682233|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682234|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682235|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682236|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682237|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682238|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682239|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682240|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682241|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682242|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682243|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682244|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682245|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682246|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682247|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682248|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682249|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682250|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682251|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682252|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682253|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682254|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
682255|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682256|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682257|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682258|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682259|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682260|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682261|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682262|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682263|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682264|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682265|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682266|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682267|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682268|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682269|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682270|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682271|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682272|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682273|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682274|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682275|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682276|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
682277|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682278|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682279|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682280|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682281|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682282|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682283|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682284|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682285|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682286|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682287|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682288|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.A)
682289|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682290|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682291|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
682292|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682293|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682294|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682295|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682296|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682297|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682298|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682299|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682300|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682301|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682302|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682303|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682304|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682305|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682306|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682307|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682308|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682309|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682310|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682311|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682312|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682313|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682314|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682315|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682316|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682317|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682318|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682319|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682320|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682321|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682322|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682323|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682324|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682325|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682326|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682327|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682328|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682329|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682330|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682331|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682332|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682333|NCT01965288|O2|Outcome|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682334|NCT01965288|O1|Outcome|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682335|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682336|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682337|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682338|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682339|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682340|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682341|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682342|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682343|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682344|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682345|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682346|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects after removal of habitual lens and prior to dispense of study lens.
682347|NCT01965288|O1|Outcome|Overall Study Group|All 60 subjects wearing habitual lens prior to dispense of study lens.
682348|NCT01965288|E2|Reported Event|Lotrafilcon B|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.)
682349|NCT01965288|E1|Reported Event|Comfilcon A|All subjects were habitual lens wearers and were randomized to a pair of study lenses. All wore the study lenses for a minimum of 8 hours a day, 7 days a week and one month of daily wear before repeating the schedule for the second pair without a washout period.
682350|NCT01965262|B1|Baseline|Overall Baseline Characteristics|"Randomized to wear the Hema-copolymer lens pair or the etafilcon A lens pair for one week then cross over to the alternate pair~Hema-copolymer Lens: Hema-copolymer lens pair or the Etafilcon A lens pair~etafilcon A Lens: Hema-copolymer lens pair or the Etafilcon A lens pair"
682351|NCT01965262|P2|Participant Flow|Etafilcon A Lens, Then Hema-copoloymer Lens|Participants were randomized to wear the etafilcon A lens pair for one week then cross over to the Hema-copolymer lens lens pair.
682352|NCT01965262|P1|Participant Flow|Hema-copolymer Lens, Then Etafilcon A Lens|Participants were randomized to wear the Hema-copolymer lens pair for one week then cross over to the etafilcon A lens pair.
682353|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682354|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682355|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682356|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682358|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682359|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682360|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682361|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682362|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682363|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682364|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682365|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682366|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682367|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682368|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682369|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682370|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682371|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682372|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682373|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682374|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682375|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682376|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682377|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682378|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682379|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682380|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682381|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682382|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682383|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682384|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682385|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682386|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682387|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682388|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682389|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682390|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682391|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682392|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682393|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682394|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
683429|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
682395|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682396|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682397|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682398|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682399|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682400|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682401|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682402|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682403|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682404|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682405|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682406|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682407|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682408|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682409|NCT01965262|O2|Outcome|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682410|NCT01965262|O1|Outcome|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682411|NCT01965262|E2|Reported Event|Etafilcon A Lens|"Participants were randomized to wear the etafilcon A lens pair for one week during the cross over study.~etafilcon A lens: contact lens"
682412|NCT01965262|E1|Reported Event|Hema-copolymer Lens|"Participants were randomized to wear the Hema-copolymer lens pair for one week during the cross over study.~Hema-copolymer: contact lens"
682413|NCT01965158|B3|Baseline|Total|Total of all reporting groups
682414|NCT01965158|B2|Baseline|Placebo|Participants received placebo orally once daily for 12 weeks.
682415|NCT01965158|B1|Baseline|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682416|NCT01965158|P2|Participant Flow|Placebo|Participants received placebo orally once daily for 12 weeks.
682417|NCT01965158|P1|Participant Flow|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682418|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
682419|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682420|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
682421|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682422|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
682423|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682424|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
682425|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682426|NCT01965158|O2|Outcome|Placebo|Participants received placebo orally once daily for 12 weeks.
682427|NCT01965158|O1|Outcome|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682428|NCT01965158|E2|Reported Event|Placebo|Participants received placebo orally once daily for 12 weeks.
682429|NCT01965158|E1|Reported Event|Naldemedine|Participants received 0.2 mg naldemedine orally once daily for 12 weeks.
682430|NCT01965067|B3|Baseline|Total|Total of all reporting groups
682431|NCT01965067|B2|Baseline|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682432|NCT01965067|B1|Baseline|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682433|NCT01965067|P2|Participant Flow|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682434|NCT01965067|P1|Participant Flow|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682435|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682436|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682437|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682438|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682439|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682440|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682441|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682442|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682443|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682444|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682445|NCT01965067|O2|Outcome|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682446|NCT01965067|O1|Outcome|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682447|NCT01965067|E2|Reported Event|H Group|"mild hypothermia with core temperatures between 34.5°C and 35°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682448|NCT01965067|E1|Reported Event|C Group|"normal thermal condition with core temperatures between 36.5°C and 37°C~sugammadex: sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state~Reversal effect of sugammadex in temperature state"
682449|NCT01964976|B3|Baseline|Total|Total of all reporting groups
682450|NCT01964976|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682451|NCT01964976|B1|Baseline|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682452|NCT01964976|P1|Participant Flow|All Population|All participants who received alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months along with biguanide or without biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682453|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682454|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682455|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682456|NCT01964976|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682457|NCT01964976|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682458|NCT01964976|O1|Outcome|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682459|NCT01964976|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682460|NCT01964976|O1|Outcome|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682461|NCT01964976|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a biguanide within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682462|NCT01964976|E1|Reported Event|Alogliptin + Biguanides|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a biguanide within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682463|NCT01964950|B3|Baseline|Total|Total of all reporting groups
682464|NCT01964950|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682465|NCT01964950|B1|Baseline|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682466|NCT01964950|P1|Participant Flow|All Population (Alogliptin)|All participants who received alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months along with an SU or without an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682467|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682468|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682469|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682470|NCT01964950|O1|Outcome|Alogliptin|Participants who took alogliptin 25 mg, tablets, orally, once daily for up to 12 months as per routine clinical practice were observed.
682471|NCT01964950|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682472|NCT01964950|O1|Outcome|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682473|NCT01964950|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682474|NCT01964950|O1|Outcome|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682475|NCT01964950|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive an SU within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682476|NCT01964950|E1|Reported Event|Alogliptin + SU|Alogliptin (Nesina) 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received an SU within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin as per routine clinical practice were observed in this study.
682477|NCT01964898|B3|Baseline|Total|Total of all reporting groups
682478|NCT01964898|B2|Baseline|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682479|NCT01964898|B1|Baseline|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682480|NCT01964898|P2|Participant Flow|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682481|NCT01964898|P1|Participant Flow|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682506|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682507|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682482|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682483|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682484|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682485|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682486|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682487|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682488|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682489|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682490|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682491|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682492|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682493|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682494|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682495|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682496|NCT01964898|O2|Outcome|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682497|NCT01964898|O1|Outcome|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682498|NCT01964898|E2|Reported Event|Standard Care|"Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 packets of printed self-help materials for smoking cessation mailed 1, 3, 6, 9, and 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Printed Self-help materials for Smoking Cessation"
682499|NCT01964898|E1|Reported Event|BA for Cardiac Patients Who Smoke|"Behavioral Activation Treatment for cardiac patients who smoke (BAT-CS). Participant will receive (a) 1 hour of standard smoking cessation counseling in the hospital and (b) 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management after they leave the hospital. BA sessions will occur over the 12 weeks after hospital discharge. An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.~Behavioral Activation (BA): 5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.~Standard Smoking Cessation Counseling: 1 hour of in hospital counseling based on clinical guidelines~Nicotine patch: An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD."
682500|NCT01964716|B3|Baseline|Total|Total of all reporting groups
682501|NCT01964716|B2|Baseline|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682502|NCT01964716|B1|Baseline|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682503|NCT01964716|P2|Participant Flow|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682504|NCT01964716|P1|Participant Flow|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682505|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
724299|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
682508|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682509|NCT01964716|O3|Outcome|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
682510|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682511|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682512|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682513|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682514|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682515|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682516|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682517|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682518|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682519|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682520|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682521|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682522|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682523|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682524|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682525|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682526|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682527|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682528|NCT01964716|O2|Outcome|13vPnC Single-Dose Syringe (SDS)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) without 2-phenoxyethanol (2-PE) in SDS intramuscularly at 8, 12 and 16 weeks of age.
682529|NCT01964716|O1|Outcome|13vPnC Multi-dose Vial (MDV)|Participants received three doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) with 2-phenoxyethanol (2-PE) in MDV intramuscularly at 8, 12 and 16 weeks of age.
682530|NCT01964716|E9|Reported Event|Screened Only|Participants who were screened for this study but were not randomized, assessed between signing of informed consent form and before randomization.
682531|NCT01964716|E8|Reported Event|13vPnC SDS: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
682532|NCT01964716|E7|Reported Event|13vPnC MDV: After Dose 3|Participants who received all three 0.5mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 3 and up to blood draw at 4 weeks.
682533|NCT01964716|E6|Reported Event|13vPnC SDS: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
682534|NCT01964716|E5|Reported Event|13vPnC MDV: After Dose 2|Participants who received two 0.5 mL doses of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg 8, 12 weeks of age, assessed after Dose 2 and before Dose 3.
682535|NCT01964716|E4|Reported Event|13vPnC SDS: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-05208760) using SDS intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
683430|NCT01958645|O1|Outcome|Placebo|Placebo (Saline solution for infusion)
682536|NCT01964716|E3|Reported Event|13vPnC MDV: After Dose 1|Participants who received single 0.5 mL dose of 13vPnC (PF-06414256) using MDV intramuscularly into the anterolateral thigh muscle of the left leg at 8 weeks of age, assessed after Dose 1 and before Dose 2.
682537|NCT01964716|E2|Reported Event|13vPnC SDS: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-05208760) SDS at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
682538|NCT01964716|E1|Reported Event|13vPnC MDV: Informed Consent to Dose 1|Participants who were randomized to receive 13vPnC (PF-06414256) MDV at 8, 12, and 16 weeks of age, assessed between signing of informed consent and before Dose 1.
682539|NCT01964547|B3|Baseline|Total|Total of all reporting groups
682540|NCT01964547|B2|Baseline|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682541|NCT01964547|B1|Baseline|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682542|NCT01964547|P2|Participant Flow|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682543|NCT01964547|P1|Participant Flow|Sativex|Each 100 μl actuation contains delta-9-tetrahydrocannabinol (THC) (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682544|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682545|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682546|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682547|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682548|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682549|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682550|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682551|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682552|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682553|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682554|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682555|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682556|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682557|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682558|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682559|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682560|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682561|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682562|NCT01964547|O2|Outcome|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682563|NCT01964547|O1|Outcome|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682564|NCT01964547|E2|Reported Event|Placebo|Each 100 μl actuation contains no active drug but colorants and excipients. The maximum permitted dose was 12 actuations in any 24 hour period.
682565|NCT01964547|E1|Reported Event|Sativex|Each 100 μl actuation contains THC (27 mg/mL) and CBD (25 mg/mL). The maximum permitted dose was 12 actuations (32.4 mg THC + 30 mg CBD) in any 24 hour period.
682566|NCT01964352|B5|Baseline|Total|Total of all reporting groups
682567|NCT01964352|B4|Baseline|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682568|NCT01964352|B3|Baseline|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682569|NCT01964352|B2|Baseline|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682570|NCT01964352|B1|Baseline|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682571|NCT01964352|P4|Participant Flow|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682572|NCT01964352|P3|Participant Flow|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682573|NCT01964352|P2|Participant Flow|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682576|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682577|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682578|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682579|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682580|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682581|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682582|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682583|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682584|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682585|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682586|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682587|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682588|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682589|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682590|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682591|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682592|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682593|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682594|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682595|NCT01964352|O4|Outcome|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682596|NCT01964352|O3|Outcome|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682597|NCT01964352|O2|Outcome|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682598|NCT01964352|O1|Outcome|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682599|NCT01964352|E4|Reported Event|Tiotropium 5 μg + Olodaterol 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682600|NCT01964352|E3|Reported Event|Tiotropium 2.5 μg+ Olodaterol 5 μg|Once daily 2 puffs solution of 1.25 μg tiotropium / 2.5 μg olodaterol for inhalation with Respimat.
682601|NCT01964352|E2|Reported Event|Tiotropium 5 μg|Once daily 2 puffs solution of 2.5 μg tiotropium for inhalation with Respimat
682602|NCT01964352|E1|Reported Event|Placebo|Once daily 2 puffs solution of placebo for inhalation with Respimat
682603|NCT01964326|B1|Baseline|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
682604|NCT01964326|P1|Participant Flow|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
682605|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
682606|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
682607|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
682608|NCT01964326|O1|Outcome|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
682609|NCT01964326|E1|Reported Event|Atorvastatin|Participants after reading the drugs fact label (DFL), made a purchase decision, purchased (on Day 1) and used atorvastatin 10 milligram (mg) OTC for 26 weeks.
682610|NCT01964222|B3|Baseline|Total|Total of all reporting groups
682611|NCT01964222|B2|Baseline|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682612|NCT01964222|B1|Baseline|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
682613|NCT01964222|P2|Participant Flow|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682614|NCT01964222|P1|Participant Flow|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
682615|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682616|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
724300|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
682617|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682618|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
682619|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682620|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
682621|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682622|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
682623|NCT01964222|O2|Outcome|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682624|NCT01964222|O1|Outcome|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
682625|NCT01964222|E2|Reported Event|Control|Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
682626|NCT01964222|E1|Reported Event|Decision Aid (DA)|"The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.~Decision Aid (DA): Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care."
682627|NCT01963845|B3|Baseline|Total|Total of all reporting groups
682628|NCT01963845|B2|Baseline|Active Drug|Sitagliptin 100 mg
682629|NCT01963845|B1|Baseline|Placebo|Sitagliptin-matched placebo tablet
682630|NCT01963845|P2|Participant Flow|Active Drug|Sitagliptin 100 mg
682631|NCT01963845|P1|Participant Flow|Placebo|Sitagliptin-matched placebo tablet
682632|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
682633|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
682634|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
682635|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
682636|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
682637|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
682638|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
682639|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
682640|NCT01963845|O2|Outcome|Active Drug|"Sitagliptin 100 mg~Sitagliptin"
682641|NCT01963845|O1|Outcome|Placebo|Sitagliptin-matched placebo tablet
682642|NCT01963845|E2|Reported Event|Active Drug|Sitagliptin 100 mg
682643|NCT01963845|E1|Reported Event|Placebo|Sitagliptin-matched placebo tablet
682644|NCT01963767|B3|Baseline|Total|Total of all reporting groups
682645|NCT01963767|B2|Baseline|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
682646|NCT01963767|B1|Baseline|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
682647|NCT01963767|P2|Participant Flow|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
682648|NCT01963767|P1|Participant Flow|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent."
682649|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
682650|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
682651|NCT01963767|O2|Outcome|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
682685|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682686|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682687|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682652|NCT01963767|O1|Outcome|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
682653|NCT01963767|E2|Reported Event|Placebo|Subjects took two pills, one in the morning and one in the evening, that were matched in size and shape to the active compound.
682654|NCT01963767|E1|Reported Event|NT-020|"Participants received two pills of NT-020 plus Biovin (900 mg proprietary formulation of blueberry, carnosine, green tea, plus 200 U Vitamin D3, 40 mg Biovin), with one to be taken in the morning and the other in the evening.~NT-020: Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) – 2000 IU BioVin® Grape Extract – 40 mg Proprietary Blend – 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*~Vaccinium angustifolium"
682655|NCT01963676|B3|Baseline|Total|Total of all reporting groups
682656|NCT01963676|B2|Baseline|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
682657|NCT01963676|B1|Baseline|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
682658|NCT01963676|P2|Participant Flow|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
682659|NCT01963676|P1|Participant Flow|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
682660|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
682661|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
682662|NCT01963676|O2|Outcome|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
682663|NCT01963676|O1|Outcome|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
682664|NCT01963676|E2|Reported Event|Sham Stimulation|"13 subjects total. An initial 40sec of stimulation at 2mA followed by a small current pulse every 550msec for the remainder of the 20 minute period.~Sham stimulation"
682665|NCT01963676|E1|Reported Event|Transcranial Direct Current Stimulation (tDCS)|"13 subjects total. 2mA stimulation for 20 minutes.~tDCS"
682666|NCT01963611|B6|Baseline|Total|Total of all reporting groups
682667|NCT01963611|B5|Baseline|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682668|NCT01963611|B4|Baseline|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682669|NCT01963611|B3|Baseline|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682670|NCT01963611|B2|Baseline|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682671|NCT01963611|B1|Baseline|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682672|NCT01963611|P5|Participant Flow|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682673|NCT01963611|P4|Participant Flow|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682674|NCT01963611|P3|Participant Flow|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682675|NCT01963611|P2|Participant Flow|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682676|NCT01963611|P1|Participant Flow|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682677|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682678|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682679|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682680|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682681|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682682|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682683|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682684|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682688|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682689|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682690|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682691|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682692|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months
682693|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682694|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682695|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682696|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682697|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682698|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682699|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682700|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682701|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682702|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682703|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682704|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682705|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682706|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682707|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682708|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682709|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682710|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682711|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682712|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682713|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682714|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682715|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682716|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682717|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682718|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682719|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682720|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682721|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682722|NCT01963611|O5|Outcome|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
682723|NCT01963611|O4|Outcome|Plovamer Acetate 20 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
682724|NCT01963611|O3|Outcome|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682725|NCT01963611|O2|Outcome|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
683431|NCT01958645|E3|Reported Event|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
682726|NCT01963611|O1|Outcome|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
682727|NCT01963611|E5|Reported Event|Copaxone 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for a minimum of 40 weeks.
682728|NCT01963611|E4|Reported Event|Plovamer Acetate 20 mg|Plovamer acetate was administered at a dose of 20 mg as weekly subcutaneous injection for a minimum of 40 weeks.
682729|NCT01963611|E3|Reported Event|Plovamer Acetate 10 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for a minimum of 40 weeks.
682730|NCT01963611|E2|Reported Event|Plovamer Acetate 3 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for a minimum of 40 weeks.
682731|NCT01963611|E1|Reported Event|Plovamer Acetate 0.5 Milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for a minimum of 40 weeks.
682732|NCT01963403|B3|Baseline|Total|Total of all reporting groups
682733|NCT01963403|B2|Baseline|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
682734|NCT01963403|B1|Baseline|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
682735|NCT01963403|P2|Participant Flow|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
682736|NCT01963403|P1|Participant Flow|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
682737|NCT01963403|O2|Outcome|No Use of COC at Any Time During 3 Months|
682738|NCT01963403|O1|Outcome|Used COC at Any Time During 3 Months|
682739|NCT01963403|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
682740|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
682741|NCT01963403|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
682742|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
682743|NCT01963403|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill per day; daily during study participation (up to 84 days)"
682744|NCT01963403|O1|Outcome|EE 30mcg/LNG 150mcg|"combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
682745|NCT01963403|E2|Reported Event|Placebo|Placebo: 1 pill per day; daily during study participation (up to 84 days)
682746|NCT01963403|E1|Reported Event|EE 30mcg/LNG 150mcg|"Combined oral contraceptive pill: ethinyl estradiol (EE) 30mcg/levonorgestrel 150mcg); 1 pill per day; daily during study participation (up to 84 days)~EE 30mcg/LNG 150mcg: 1 pill per day; daily during study participation (up to 84 days)"
682747|NCT01963260|B11|Baseline|Total|Total of all reporting groups
682748|NCT01963260|B10|Baseline|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
682749|NCT01963260|B9|Baseline|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
682750|NCT01963260|B8|Baseline|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
682751|NCT01963260|B7|Baseline|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682752|NCT01963260|B6|Baseline|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
682753|NCT01963260|B5|Baseline|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682754|NCT01963260|B4|Baseline|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682755|NCT01963260|B3|Baseline|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682756|NCT01963260|B2|Baseline|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682757|NCT01963260|B1|Baseline|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682758|NCT01963260|P10|Participant Flow|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
682759|NCT01963260|P9|Participant Flow|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants with ITP from Part 2 MK-8723 10 mg/kg were re-enrolled into Part 2 100 mg/kg and dosed (not shown).
682760|NCT01963260|P8|Participant Flow|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
682761|NCT01963260|P7|Participant Flow|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with immune thrombocytopenia purpura (ITP) in Part 2. 2 participants were subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682762|NCT01963260|P6|Participant Flow|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
682763|NCT01963260|P5|Participant Flow|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
724301|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
682764|NCT01963260|P4|Participant Flow|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682765|NCT01963260|P3|Participant Flow|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682766|NCT01963260|P2|Participant Flow|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682767|NCT01963260|P1|Participant Flow|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682768|NCT01963260|O8|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
682769|NCT01963260|O7|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
682770|NCT01963260|O6|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682771|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682772|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682773|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682774|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682775|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682776|NCT01963260|O8|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
682777|NCT01963260|O7|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
682778|NCT01963260|O6|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682779|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682780|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682781|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682782|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682783|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682784|NCT01963260|O4|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
682785|NCT01963260|O3|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
682786|NCT01963260|O2|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
682787|NCT01963260|O1|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682788|NCT01963260|O10|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
682789|NCT01963260|O9|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
682790|NCT01963260|O8|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
682791|NCT01963260|O7|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682792|NCT01963260|O6|Outcome|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
682793|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682794|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682795|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682796|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682797|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682798|NCT01963260|O10|Outcome|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
682799|NCT01963260|O9|Outcome|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
682800|NCT01963260|O8|Outcome|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
683432|NCT01958645|E2|Reported Event|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
682801|NCT01963260|O7|Outcome|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682802|NCT01963260|O6|Outcome|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
682803|NCT01963260|O5|Outcome|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682804|NCT01963260|O4|Outcome|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682805|NCT01963260|O3|Outcome|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682806|NCT01963260|O2|Outcome|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682807|NCT01963260|O1|Outcome|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682808|NCT01963260|E10|Reported Event|Part 2: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to participants with ITP in Part 2.
682809|NCT01963260|E9|Reported Event|Part 2: MK-8723 100 mg/kg in ITP Participants|MK-8723 100 mg/kg administered as a single IV infusion to participants with ITP in Part 2. This group includes 2 participants that re-enrolled from Part 2 MK-8723 10 mg/kg.
682810|NCT01963260|E8|Reported Event|Part 2: MK-8723 30 mg/kg in ITP Participants|MK-8723 30 mg/kg administered as a single IV infusion to participants with ITP in Part 2.
682811|NCT01963260|E7|Reported Event|Part 2: MK-8723 10 mg/kg in ITP Participants|MK-8723 10 mg/kg administered as a single IV infusion to participants with ITP in Part 2. 2 participants subsequently enrolled in Part 2 MK-8723 100 mg/kg.
682812|NCT01963260|E6|Reported Event|Part 1: Matching Placebo to MK-8723|Matching placebo to MK-8723 administered as a single IV infusion to healthy participants in Part 1.
682813|NCT01963260|E5|Reported Event|Part 1: MK-8723 100 mg/kg in Healthy Participants|MK-8723 100 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682814|NCT01963260|E4|Reported Event|Part 1: MK-8723 30 mg/kg in Healthy Participants|MK-8723 30 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682815|NCT01963260|E3|Reported Event|Part 1: MK-8723 10 mg/kg in Healthy Participants|MK-8723 10 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682816|NCT01963260|E2|Reported Event|Part 1: MK-8723 3 mg/kg in Healthy Participants|MK-8723 3 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682817|NCT01963260|E1|Reported Event|Part 1: MK-8723 1 mg/kg in Healthy Participants|MK-8723 1 mg/kg administered as a single IV infusion to healthy participants in Part 1.
682818|NCT01963143|B4|Baseline|Total|Total of all reporting groups
682819|NCT01963143|B3|Baseline|Pediatrics|Gammaplex 10 on a 21 or 28 day schedule
682820|NCT01963143|B2|Baseline|Treatment Sequence 2 - Adults|Gammaplex 5% and Gammaplex 10 on a 28-day schedule
682821|NCT01963143|B1|Baseline|Treatment Sequence 1 - Adults|Gammaplex 5% and Gammaplex 10 on a 21-day schedule
682822|NCT01963143|P3|Participant Flow|Pediatrics|Gammaplex 10 on a 21 or 28 day treatment schedule
682823|NCT01963143|P2|Participant Flow|Treatment Sequence 2 - Adults|Gammaplex 10 and Gammaplex 5% on a 28-day treatment schedule
682824|NCT01963143|P1|Participant Flow|Treatment Sequence 1 - Adults|Gammaplex 5% & Gammaplex 10 on a 21-day treatment schedule
682825|NCT01963143|O2|Outcome|Gammaplex 5%|
682826|NCT01963143|O1|Outcome|Gammaplex 10%|
682827|NCT01963143|O2|Outcome|Gammaplex 5%|
682828|NCT01963143|O1|Outcome|Gammaplex 10%|
682829|NCT01963143|O2|Outcome|Gammaplex 5%|
682830|NCT01963143|O1|Outcome|Gammaplex 10%|
682831|NCT01963143|E2|Reported Event|Gammaplex 10% - All Subjects|Subjects aged 2-55 years
682832|NCT01963143|E1|Reported Event|Gammaplex 5% - All Subjects|Subjects aged 17-55 years
682833|NCT01963091|B3|Baseline|Total|Total of all reporting groups
682834|NCT01963091|B2|Baseline|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682835|NCT01963091|B1|Baseline|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682836|NCT01963091|P2|Participant Flow|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682837|NCT01963091|P1|Participant Flow|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682957|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
683433|NCT01958645|E1|Reported Event|Placebo|Placebo (Saline solution for infusion)
682838|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682839|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682840|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682841|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682842|NCT01963091|O2|Outcome|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682843|NCT01963091|O1|Outcome|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682844|NCT01963091|E2|Reported Event|Placebo|saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682845|NCT01963091|E1|Reported Event|Oxytocin|oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
682846|NCT01962974|B1|Baseline|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
682847|NCT01962974|P1|Participant Flow|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
682848|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
682849|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
682850|NCT01962974|O1|Outcome|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
682851|NCT01962974|E1|Reported Event|Golimumab|Participants received golimumab 2 milligram per kilogram (mg/kg) intravenously (IV) at Weeks 0, 4, 12, 20, and 28.
682852|NCT01962961|B4|Baseline|Total|Total of all reporting groups
682853|NCT01962961|B3|Baseline|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682854|NCT01962961|B2|Baseline|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
682866|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
682855|NCT01962961|B1|Baseline|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682856|NCT01962961|P3|Participant Flow|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682857|NCT01962961|P2|Participant Flow|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
682858|NCT01962961|P1|Participant Flow|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682859|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682860|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
682861|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682862|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682863|NCT01962961|O2|Outcome|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
682864|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682865|NCT01962961|O3|Outcome|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682912|NCT01962493|B2|Baseline|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682867|NCT01962961|O1|Outcome|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682868|NCT01962961|E3|Reported Event|Placebo|"Matching placebo pills given twice daily for 8 weeks~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682869|NCT01962961|E2|Reported Event|PharmaNAC 3600 mg|"PharmaNAC 1800 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
682870|NCT01962961|E1|Reported Event|PharmaNAC 1800 mg|"PharmaNAC 900 mg orally twice daily for 8 weeks~PharmaNAC (N-acetylcysteine): PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days).~Matching placebo: Inactive pill that matches PharmaNAC on taste, color, and appearance."
682871|NCT01962922|B3|Baseline|Total|Total of all reporting groups
682872|NCT01962922|B2|Baseline|Sequence II|Sequence II Envarsus XR→IR-Tac (N = 23)
682873|NCT01962922|B1|Baseline|Sequence I|Sequence I IR-Tac→Envarsus XR (N = 27)
682874|NCT01962922|P2|Participant Flow|Sequence 2|"• Sequence II: (n=23) 1 Patients receive Envarsus XR tablets (at 15% lower dose than their IR-Tac dose) on Days 1–7 (24-hour PK profile on Day 7), then patients are switched back to twice-daily Tac - IR treatment beginning on Day 8. PK on days 14 and 21.~Patients in sequence 2 are on Tac - IR at Day 21. Patient have option of continuing in extension portion of the study on Tac - IR for up to 6 months."
682875|NCT01962922|P1|Participant Flow|Sequence 1|"•Sequence I: (n=27) Patients will continue on twice-daily IR-Tac capsules on Days 1–7 (24-hour PK profile on Day 7), then patients are switched to Envarsus XR tablets (at a dose 15% lower than their Tac - IR doses) on Day 8. PK on day 14 and 21.~Patients in sequence 1 are on Envarsus XR at Day 21. Patient may continue on extension up to a total of 6 months."
682876|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682877|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682878|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682879|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682880|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682881|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682882|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682883|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682884|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682885|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682886|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682887|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682888|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682889|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682890|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682891|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682892|NCT01962922|O2|Outcome|Tacrolimus - IR|Tacrolimus capsules twice daily.
682893|NCT01962922|O1|Outcome|Envarsus XR|Tacrolimus tablets once daily.
682894|NCT01962922|E2|Reported Event|Tacrolimus - IR|brand IR tacrolimus
682895|NCT01962922|E1|Reported Event|Envarsus XR|Tacrolimus extended release
682896|NCT01962675|B3|Baseline|Total|Total of all reporting groups
682897|NCT01962675|B2|Baseline|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
682898|NCT01962675|B1|Baseline|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
682899|NCT01962675|P2|Participant Flow|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
682900|NCT01962675|P1|Participant Flow|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
682901|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
682902|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
682903|NCT01962675|O2|Outcome|Sham tDCS - Real tDCS|"Sham tDCS+skilled training~Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles~Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles"
682904|NCT01962675|O1|Outcome|Real tDCS - Sham tDCS|"Real tDCS+skilled training~Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Step training: Stepping over specified soft foam obstacles~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles~Sham tDCS+skilled training Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Step training: Stepping over specified soft foam obstacles"
682905|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
682906|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
682907|NCT01962675|O2|Outcome|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
682908|NCT01962675|O1|Outcome|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
682909|NCT01962675|E2|Reported Event|Sham tDCS and Skilled Leg Training|"Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
682910|NCT01962675|E1|Reported Event|tDCS and Skilled Training|"tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training~Transcranial direct current stimulation + step training: Direct current stimulation of motor cortex with low stimulation intensity~Sham transcranial direct current stimulation + step training: Stepping over specified soft foam obstacles"
682911|NCT01962493|B3|Baseline|Total|Total of all reporting groups
682955|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682990|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
682913|NCT01962493|B1|Baseline|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682914|NCT01962493|P2|Participant Flow|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682915|NCT01962493|P1|Participant Flow|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682916|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682917|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682918|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682919|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682920|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682921|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682922|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682923|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682924|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682925|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682926|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682927|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682956|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682928|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682929|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682930|NCT01962493|O2|Outcome|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682931|NCT01962493|O1|Outcome|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682932|NCT01962493|E2|Reported Event|NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of Non-sodium bicarbonate toothpaste containing 1450 ppm fluoride as NaF and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682933|NCT01962493|E1|Reported Event|NaHCO3/NaF Toothpaste + Chlorhexidine Digluconate Mouthwash|Participants applied a strip of 67% Sodium bicarbonate (NaHCO3) toothpaste (containing 1400 parts per million (ppm) fluoride as Sodium fluoride (NaF)) and brushed for one timed minute. After brushing their teeth, participants rinsed their mouths thoroughly with water and waited 5 timed minutes before rinsing with 10 millilitres (mL) of 0.2% w/v Chlorhexidine Digluconate mouthwash for one timed minute in their normal manner.
682934|NCT01962441|B4|Baseline|Total|Total of all reporting groups
682935|NCT01962441|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682936|NCT01962441|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682937|NCT01962441|B1|Baseline|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682938|NCT01962441|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks
682939|NCT01962441|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682940|NCT01962441|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet administered orally once daily + ribavirin (RBV) tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682941|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682942|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682943|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682944|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682945|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682946|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682947|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682948|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682949|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682950|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682951|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682952|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682953|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682954|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682958|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682959|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682960|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682961|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682962|NCT01962441|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682963|NCT01962441|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682964|NCT01962441|O1|Outcome|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682965|NCT01962441|E3|Reported Event|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks
682966|NCT01962441|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 24 weeks
682967|NCT01962441|E1|Reported Event|SOF+RBV 16 Weeks|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 16 weeks
682968|NCT01962428|B3|Baseline|Total|Total of all reporting groups
682969|NCT01962428|B2|Baseline|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682970|NCT01962428|B1|Baseline|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682971|NCT01962428|P2|Participant Flow|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682972|NCT01962428|P1|Participant Flow|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682973|NCT01962428|O2|Outcome|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682974|NCT01962428|O1|Outcome|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682975|NCT01962428|E2|Reported Event|High Loading Dose of Ticagrelor|"Patients will receive ticagrelor 360mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682976|NCT01962428|E1|Reported Event|Conventional Loading Dose of Ticagrelor|"Patients will receive ticagrelor 180mg loading dose, then 90mg bid maintenance dose starting 12 hours after loading dose.~ticagrelor: Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose."
682977|NCT01961544|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
682978|NCT01961544|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
682979|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
682980|NCT01961544|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2 to 5 minutes on Day 1 and Day 8 of each 21-day cycle.
682981|NCT01961544|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Participants received 1.4 milligrams per meters squared (mg/m^2) eribulin mesylate intravenously over the course of 2-5 minutes on Day 1 and Day 8 of each 21-day cycle.
682982|NCT01961349|B4|Baseline|Total|Total of all reporting groups
682983|NCT01961349|B3|Baseline|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
682984|NCT01961349|B2|Baseline|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
682985|NCT01961349|B1|Baseline|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
682986|NCT01961349|P3|Participant Flow|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
682987|NCT01961349|P2|Participant Flow|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
682988|NCT01961349|P1|Participant Flow|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
682989|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
682991|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
682992|NCT01961349|O3|Outcome|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
682993|NCT01961349|O2|Outcome|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
682994|NCT01961349|O1|Outcome|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
682995|NCT01961349|E3|Reported Event|ICI35,868 With EES0000645/A|ICI35,868 administered and EES0000645/A operated by the GI physician or the nurse
682996|NCT01961349|E2|Reported Event|ICI35,868 Without EES0000645/A|ICI35,868 administered by the anaesthesiologist without EES0000645/A
682997|NCT01961349|E1|Reported Event|Placebo|Placebo administered by the anaesthesiologist without EES0000645/A
682998|NCT01961271|B1|Baseline|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
682999|NCT01961271|P1|Participant Flow|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683000|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683001|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683002|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683003|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683004|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683005|NCT01961271|O1|Outcome|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683006|NCT01961271|E1|Reported Event|Buprenorphine Transdermal Patch|"Subjects will be on either 5mg, 10mg, 15mg, 20mg, 25mg, 30mg or 40mg doses for 17 weeks. Dose titration will occur every week for the first 6 weeks, and will be maintained for the next 11 weeks.~Buprenorphine transdermal patch: Please see Arm Description."
683007|NCT01960907|B3|Baseline|Total|Total of all reporting groups
683008|NCT01960907|B2|Baseline|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
683009|NCT01960907|B1|Baseline|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
683010|NCT01960907|P2|Participant Flow|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
683011|NCT01960907|P1|Participant Flow|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
683012|NCT01960907|O2|Outcome|Observational, Previously Hopitalized for COPD Exacerb.|Patients in the observational group that were hospitalized the year before the study for a COPD exacerbation
683013|NCT01960907|O1|Outcome|Monitored, Previously Hopitalized for COPD Exacerbation|Patients in the monitored group that were hospitalized the year before the study for a COPD exacerbation
683014|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
683015|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS."
683054|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683055|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683056|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683016|NCT01960907|O2|Outcome|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
683017|NCT01960907|O1|Outcome|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
683018|NCT01960907|E2|Reported Event|Interventional|"Patients received a system for monitoring their health status.~The system is composed by:~a touch-screen pc for the administration of daily questionnaires~RESMON PRO DIARY for the measurement of lung mechanical impedance and breathing pattern~a Medic4all Wrist Clinic for the assessment of heart rate, blood pressure, saturation, 1 lead ECG, body temperature.~Subjects received additional medical treatment following the activation of alarms by the monitoring devices.~Monthly phone interviews were performed to collect data bout their status and level of utilization of healthcare resources."
683019|NCT01960907|E1|Reported Event|Observational|"Subjects in the observational arm received monthly interviews for collecting informations about their status and level of utilization of healthcare resources.~They followed their usual care path as provided by their local NHS"
683020|NCT01960842|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683021|NCT01960842|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683022|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683023|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683024|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683025|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683026|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683057|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683058|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683059|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683434|NCT01958619|B5|Baseline|Total|Total of all reporting groups
683027|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683028|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683029|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683030|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683031|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683032|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683033|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683034|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683035|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683036|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683060|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
724302|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
683037|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683038|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683039|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683040|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683041|NCT01960842|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683042|NCT01960842|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants received LCIG via the N-J tube during the nasojejunal (N-J) Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy - with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the PEG-J Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour)."
683043|NCT01960816|B1|Baseline|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
683044|NCT01960816|P1|Participant Flow|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
683045|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
683046|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
683047|NCT01960816|O1|Outcome|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
683048|NCT01960816|E1|Reported Event|InFlux System|"Intervention: Procedure: thermal coagulation of tissue in the nasal airway~Procedure: thermal coagulation of tissue in the nasal airway: The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage."
683049|NCT01960725|B3|Baseline|Total|Total of all reporting groups
683050|NCT01960725|B2|Baseline|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683051|NCT01960725|B1|Baseline|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683052|NCT01960725|P2|Participant Flow|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683053|NCT01960725|P1|Participant Flow|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
724303|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
683061|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683062|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683063|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683064|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683065|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683066|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683067|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683068|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683069|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683070|NCT01960725|O2|Outcome|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683071|NCT01960725|O1|Outcome|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683072|NCT01960725|E2|Reported Event|Group B: Alternate Dosing|"Group will receive RV5 vaccine at 2-5 weeks, 2 and 4 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683073|NCT01960725|E1|Reported Event|Group A: Standard Dosing|"Group will receive RV5 vaccine at 2, 4, and 6 months of age~RV5 (Pentavalent Rotavirus Vaccine)"
683074|NCT01960530|B1|Baseline|All Participants|All participants received no IMP, dexamethasone (non-IMP), oral infacort, oral hydrocortisone, i.v. hydrocortisone
683075|NCT01960530|P1|Participant Flow|5-period Crossover|"Study Period 1 (Endogenous Cortisol): No IMP was administered. Subjects were observed over a 24 hour period, during which sleep disruption was minimised, to record their endogenous cortisol production as a baseline figure and to confirm eligibility for the subsequent study periods.~Study Period 2 (Dexamethasone): Subjects were admitted to the unit following a final confirmation of eligibility, prior to administration with Dexamethasone.~Study Periods 3 and 4 (Infacort Granules or Hydrocortisone Tablets): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received both treatments (1 in Period 3, and 1 in Period 4), and were randomised using the PROC PLAN procedure of SAS. Subjects received Dexamethasone 1 hour prior to IMP administration.~Study Period 5 (I.V. Hydrocortisone Injection): Subjects were admitted to the unit and ongoing eligibility was confirmed. Subjects received Dexamethasone 1 hour prior to IMP administration."
683076|NCT01960530|O3|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
683077|NCT01960530|O2|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
683078|NCT01960530|O1|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
683079|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
683080|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
683081|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
683082|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
683083|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
683084|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
683149|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683150|NCT01960296|E2|Reported Event|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683085|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
683086|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
683087|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
683088|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
683089|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
683090|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
683091|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
683092|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
683093|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
683094|NCT01960530|O5|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
683095|NCT01960530|O4|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
683096|NCT01960530|O3|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
683097|NCT01960530|O2|Outcome|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
683098|NCT01960530|O1|Outcome|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
683099|NCT01960530|O3|Outcome|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
683100|NCT01960530|O2|Outcome|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
683101|NCT01960530|O1|Outcome|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
683102|NCT01960530|E5|Reported Event|i.v Hydrocortisone Injection|"20mg i.v. Hydrocortisone Injection will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~i.v. Hydrocortisone Injection"
683151|NCT01960296|E1|Reported Event|Clopidogrel|Continue home dose of clopidogrel into surgery
724304|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
683103|NCT01960530|E4|Reported Event|Hydrocortisone Tablet|"20mg Hydrocortisone Tablet will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous ACTH and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Hydrocortisone Tablet"
683104|NCT01960530|E3|Reported Event|Infacort®|"20mg Infacort® will be administered on Day 2 at 07:00. Dexamethasone is a challenge agent and will be taken to suppress endogenous Adrenocorticotropic Hormone(ACTH)and Cortisol. 1mg Dexamethasone will be administered at 22:00 on Day 1 and 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Infacort"
683105|NCT01960530|E2|Reported Event|Dexamethasone|"1mg Dexamethasone will be administered at 22:00 on Day 1 and at 06:00 and 12:00 on Day 2. Various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.~Dexamethasone"
683106|NCT01960530|E1|Reported Event|Endogenous Cortisol|No Study medication will be given during this study period, however various blood, urine and saliva samples will be taken in order to measure normal levels of hormones and other chemicals at several time-points.
683107|NCT01960400|B3|Baseline|Total|Total of all reporting groups
683108|NCT01960400|B2|Baseline|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
683109|NCT01960400|B1|Baseline|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
683110|NCT01960400|P2|Participant Flow|GMI + Sham TDCS|"Graded motor imagery (GMI) + sham tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
683111|NCT01960400|P1|Participant Flow|GMI + tDCS|"Graded motor imagery (GMI) + tDCS~tDCS: both groups will receive the GMI treatments which will be performed using software and well-established procedures (www.noigroup.com). For its part, the tDCS will be applied for 5 consecutive days during the first 2 weeks of phase 1 and once a week during the 4 other weeks. The anodic (positive) stimulation over the motor cortex (M1) contralateral of the affected limb is sought to modulate cortical excitability and promote pain inhibition and cortical reorganization."
683112|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683113|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683114|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683115|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683116|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683191|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683117|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683118|NCT01960400|O2|Outcome|Placebo tDCS + GMI|"tDCS: For the group receiving the placebo tDCS, the electrodes were placed in the same position as for active stimulation using the tDCS stimulator, but with the placebo mode automatically turned off after 30 seconds of stimulation). This type of sham stimulation has been shown to reliably blind subjects (Gandiga et al., 2006).~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683119|NCT01960400|O1|Outcome|Active tDCS + GMI|"tDCS: In the laboratory, a constant current of an intensity of 2 mA (subthreshold intensity) was applied for 20 minutes a day for five consecutive days (Monday to Friday) during the first and the second weeks of GMI (see Fig. 1A). To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week (Monday) during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.~tDCS + GMI: In the laboratory, after 8 minutes of tDCS application, patients were asked to perform their GMI treatments with the help of a portable computer. Seated comfortably, the patients had to perform the exercises according to the treatment phase for a period of 10 minutes."
683120|NCT01960400|E2|Reported Event|GMI + Placebo tDCS|Graded motor imagery (GMI) + placebo tDCS
683121|NCT01960400|E1|Reported Event|GMI + Active tDCS|Graded motor imagery (GMI) + active tDCS
683122|NCT01960387|B1|Baseline|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
683123|NCT01960387|P1|Participant Flow|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Patients with newly diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
683124|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
683125|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
683126|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
683127|NCT01960387|O1|Outcome|Clofarabine (40mg/m^2/Day) + Cytarabine (1g/m^2/Day)|Clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m^2 daily plus Cytarabine at a dose of 1g/m^2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration on days 1 through 5.
683128|NCT01960387|E1|Reported Event|Clofarabine (40mg/m2/Day) + Cytarabine (1g/m2/Day)|Patients with Newly Diagnosed Acute Myeloid Leukemia who received clofarabine administered as a 1-2 hour intravenous infusion at a dose of 40mg/m2 daily plus cytarabine at a dose of 1g/m2 daily, 2-4 hours maximum intravenous infusion starting 3-4 hours post completion of clofarabine administration, on days 1 through 5.
683129|NCT01960296|B3|Baseline|Total|Total of all reporting groups
683130|NCT01960296|B2|Baseline|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683131|NCT01960296|B1|Baseline|Clopidogrel|Continue home dose of clopidogrel into surgery
683132|NCT01960296|P2|Participant Flow|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683133|NCT01960296|P1|Participant Flow|Clopidogrel|Continue home dose of clopidogrel into surgery
683134|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683135|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683136|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683137|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683138|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683139|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683140|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683141|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683142|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683143|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683144|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683145|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683146|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683147|NCT01960296|O1|Outcome|Clopidogrel|Continue home dose of clopidogrel into surgery
683148|NCT01960296|O2|Outcome|Discontinue|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
683152|NCT01960140|B1|Baseline|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-mg tablet of simvastatin administered orally on Day 1.~Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
683153|NCT01960140|P1|Participant Flow|Simvastatin Then Baricitinib and Simvastatin|"Period 1: 40-milligram (mg) tablet of simvastatin administered orally on Day 1.~Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally once daily (QD) on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6."
683154|NCT01960140|O2|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of Baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
683155|NCT01960140|O1|Outcome|Simvastatin|Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
683156|NCT01960140|O2|Outcome|Baricitinib and Simvastatin|Period 2: 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 7, with coadministration of 40-mg simvastatin tablet on Day 6.
683157|NCT01960140|O1|Outcome|Simvastatin|Period 1: 40-mg tablet of simvastatin administered orally on Day 1.
683158|NCT01960140|E3|Reported Event|Baricitinib and Simvastatin|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 6 and 7, with coadministration of 40-mg simvastatin tablet on Day 6.~AEs are reported postdose on Day 6 up to Day 18."
683159|NCT01960140|E2|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 × 4-mg and 1 × 2-mg tablets) administered orally QD on Days 3 through 5.~AEs are reported postdose on Day 3 through predose on Day 6."
683160|NCT01960140|E1|Reported Event|Simvastatin|"A 40-mg tablet of simvastatin administered orally on Day 1.~Adverse events (AEs) are reported from baseline through predose on Day 3."
683161|NCT01960114|B3|Baseline|Total|Total of all reporting groups
683162|NCT01960114|B2|Baseline|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683163|NCT01960114|B1|Baseline|Placebo|Placebo (two matching placebo tablets)
683164|NCT01960114|P2|Participant Flow|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683165|NCT01960114|P1|Participant Flow|Placebo|Placebo (two matching placebo tablets)
683166|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683167|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
683168|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683169|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
683170|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683171|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
683172|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683173|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
683174|NCT01960114|O2|Outcome|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683175|NCT01960114|O1|Outcome|Placebo|Placebo (two matching placebo tablets)
683176|NCT01960114|E2|Reported Event|ACE ER 1500 mg|Acetaminophen ER 1500 mg (two 750 mg ER tablets)
683177|NCT01960114|E1|Reported Event|Placebo|Placebo (two matching placebo tablets)
683178|NCT01959945|B5|Baseline|Total|Total of all reporting groups
683179|NCT01959945|B4|Baseline|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683180|NCT01959945|B3|Baseline|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683181|NCT01959945|B2|Baseline|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683182|NCT01959945|B1|Baseline|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683183|NCT01959945|P4|Participant Flow|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683184|NCT01959945|P3|Participant Flow|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683185|NCT01959945|P2|Participant Flow|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683186|NCT01959945|P1|Participant Flow|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683187|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683188|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683189|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683190|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683435|NCT01958619|B4|Baseline|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683192|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683193|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683194|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683195|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683196|NCT01959945|O3|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683197|NCT01959945|O2|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683198|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683199|NCT01959945|O4|Outcome|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683200|NCT01959945|O3|Outcome|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683201|NCT01959945|O2|Outcome|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683202|NCT01959945|O1|Outcome|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683203|NCT01959945|E4|Reported Event|Study Group 4, Fluarix Cohort B|"Participants at 6 years to 8 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683204|NCT01959945|E3|Reported Event|Study Group 2, Fluarix Cohort A|"Participants at 9 years to 17 years of age at enrollment, Fluarix Quadrivalent® Influenza Virus Vaccine~Fluarix Quadrivalent® Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683205|NCT01959945|E2|Reported Event|Study Group 3, Flublok Cohort B|"Participants at 6 years to 8 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683206|NCT01959945|E1|Reported Event|Study Group 1, Flublok Cohort A|"Participants at 9 years to 17 years of age at enrollment, Flublok® Quadrivalent Influenza Virus Vaccine~Flublok® Quadrivalent Influenza Virus Vaccine: Intramuscular (Relevant year formulation)"
683207|NCT01959932|B4|Baseline|Total|Total of all reporting groups
683208|NCT01959932|B3|Baseline|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
683209|NCT01959932|B2|Baseline|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
683210|NCT01959932|B1|Baseline|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
683211|NCT01959932|P3|Participant Flow|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
683212|NCT01959932|P2|Participant Flow|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
683213|NCT01959932|P1|Participant Flow|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
683214|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
683215|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
683216|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
683217|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
683218|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
683219|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
683220|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
683221|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
683222|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
683223|NCT01959932|O3|Outcome|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
683224|NCT01959932|O2|Outcome|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
683225|NCT01959932|O1|Outcome|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
683226|NCT01959932|E4|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -2) but were not randomized in 1 of the 3 arms as they were back-up subjects
683227|NCT01959932|E3|Reported Event|Conventional Cigarette (CC)|Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
683228|NCT01959932|E2|Reported Event|Smoking Abstinence (SA)|Abstinence from smoking for 5 days in confinement
683229|NCT01959932|E1|Reported Event|Tobacco Heating System (THS 2.2)|Ad libitum use of THS 2.2 for 5 days in confinement
683230|NCT01959880|B5|Baseline|Total|Total of all reporting groups
683289|NCT01959503|P1|Participant Flow|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683231|NCT01959880|B4|Baseline|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
683232|NCT01959880|B3|Baseline|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
683233|NCT01959880|B2|Baseline|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
683234|NCT01959880|B1|Baseline|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
683235|NCT01959880|P4|Participant Flow|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
683236|NCT01959880|P3|Participant Flow|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
683237|NCT01959880|P2|Participant Flow|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
683238|NCT01959880|P1|Participant Flow|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
683239|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
683240|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
683241|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
683242|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
683243|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
683244|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
683245|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
683246|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
683247|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
683248|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
683249|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
683250|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
683251|NCT01959880|O4|Outcome|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
683252|NCT01959880|O3|Outcome|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
683253|NCT01959880|O2|Outcome|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
683254|NCT01959880|O1|Outcome|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
683255|NCT01959880|E4|Reported Event|Revision Reconstruction|Patients in this cohort will have had previous breast reconstruction with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast reconstruction surgery.
683256|NCT01959880|E3|Reported Event|Revison Augmentation|Patients in this cohort will have had previous breast augmentation with silicone or saline filled implants and are having a revision surgery to correct or improve the result of any previous breast augmentation surgery.
683290|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683257|NCT01959880|E2|Reported Event|Primary Reconstruction|"The Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity.~Congenital deformities will include deformities of the breast itself as well as skeletal abnormalities reflected in breast deformity or asymmetry."
683258|NCT01959880|E1|Reported Event|Primary Augmentation|The Augmentation cohort will include patients who have post-lactational mammary involution or wish general breast enlargement.
683259|NCT01959685|B1|Baseline|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
683260|NCT01959685|P1|Participant Flow|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
683261|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
683262|NCT01959685|O1|Outcome|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
683263|NCT01959685|E1|Reported Event|Up to 250 mg Androxal|Subjects received a single dose each of placebo, 125 mg Androxal and 250 mg Androxal
683264|NCT01959607|B3|Baseline|Total|Total of all reporting groups
683265|NCT01959607|B2|Baseline|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
683266|NCT01959607|B1|Baseline|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
683267|NCT01959607|P4|Participant Flow|NRT Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single administration of NRT gum [Nicorette ® 2mg])~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
683268|NCT01959607|P3|Participant Flow|THS 2.2 Then NRT|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single administration of NRT gum [Nicorette ® 2mg])."
683269|NCT01959607|P2|Participant Flow|CC Then THS 2.2|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of CC)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of THS 2.2)."
683270|NCT01959607|P1|Participant Flow|THS 2.2 Then CC|"Each subject will follow the below study design:~Day 0 = Wash-out (1 day)~Day 1 = 1st intervention (single product use of THS 2.2)~Day 2 = wash-out~Day 3 = 2nd intervention (single product use of CC)."
683271|NCT01959607|O1|Outcome|Ratio THS 2.2:CC|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2."
683272|NCT01959607|O1|Outcome|Ratio THS 2.2:CC|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
683273|NCT01959607|E3|Reported Event|Enrolled But Not Randomized|Subjects who tried the THS 2.2 at Admission (Day -1) but were not randomized in 1 of the 2 groups as they were back-up subjects
683274|NCT01959607|E2|Reported Event|Group 2|"This population comprises the following sequences:~Sequence THS 2.2 then NRT~Sequence NRT then THS 2.2"
683275|NCT01959607|E1|Reported Event|Group 1|"This population comprises the following sequences:~Sequence THS 2.2 then CC~Sequence CC then THS 2.2"
683276|NCT01959516|B1|Baseline|All Participants (Intent To Treat Analysis,ITT)|All participants who were randomized to one of the two treatment sequences in a ratio of 1:1. Participants will receive sequence A = glycopyrronium + placebo to tiotropium during 28 days, followed by a 14 day washout period, then sequence B= tiotropium + placebo to glycopyrronium for 28 days.
683277|NCT01959516|P2|Participant Flow|Tiotropium First, Then Glycopyrronium|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
683278|NCT01959516|P1|Participant Flow|"Glycopyrronium First, Then Tiotropium"|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
683279|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
683280|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
683281|NCT01959516|O2|Outcome|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
683282|NCT01959516|O1|Outcome|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
683283|NCT01959516|E2|Reported Event|Tiotropium From Sequence A to B and Sequence B to A|Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD + placebo of tiotropiumto) Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium)
683284|NCT01959516|E1|Reported Event|Glycopyronium From Sequence A to B and Sequence B to A|Sequence A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto) to B (Tiotropium 18 μg QD + placebo of glycopyrronium) Sequence B (Tiotropium 18 μg QD + placebo of glycopyrronium) to A (Glycopyrronium 44 μg QD+ placebo of tiotropiumto)
683285|NCT01959503|B3|Baseline|Total|Total of all reporting groups
683286|NCT01959503|B2|Baseline|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683287|NCT01959503|B1|Baseline|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683288|NCT01959503|P2|Participant Flow|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683661|NCT01957579|O4|Outcome|12 mg/kg (MM)|MM patients in MEDI-551 12 mg/kg cohort
683291|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683292|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683293|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683294|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683295|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683296|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683297|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683298|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683299|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683300|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683301|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683302|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683303|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683304|NCT01959503|O2|Outcome|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683305|NCT01959503|O1|Outcome|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683306|NCT01959503|E2|Reported Event|Gelfoam Plus|"Gelfoam Plus Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Gelfoam Plus"
683307|NCT01959503|E1|Reported Event|Progel Vascular Sealant|"Progel Vascular Sealant after confirmation of anastomotic leakage during intra-procedure leak test.~Progel Vascular Sealant"
683308|NCT01959412|B1|Baseline|All Participants|All participants randomized to one of six treatment sequences
683309|NCT01959412|P6|Participant Flow|Sequence 6 (Placebo)|Placebo, indacaterol 37.5 μg, indacaterol 27.5 μg indacaterol 55 μg, indacaterol 150 μg, indacaterol 75 μg Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
683310|NCT01959412|P5|Participant Flow|Sequence 5 (Ind 27.5 μg)|indacaterol 27.5 μg placebo indacaterol 150 μg indacaterol 37.5 μg indacaterol 75 μg indacaterol 55 μg Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
683311|NCT01959412|P4|Participant Flow|Sequence 1 (Ind 37.5 μg)|indacaterol 37.5 μg indacaterol 55μg Placebo indacaterol 75μg indacaterol 27.5μg indacaterol 150μg indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
683312|NCT01959412|P3|Participant Flow|Sequence 2 (Ind 55 μg)|indacaterol 55 μg indacaterol 75 μg indacaterol 37.5 μg indacaterol 150 μg placebo indacaterol 27.5 μg Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
683313|NCT01959412|P2|Participant Flow|Sequence 3 (Ind 75 μg)|indacaterol 75 μg indacaterol 150 μg indacaterol 55 μg indacaterol 27.5 μg indacaterol 37.5 μg placebo Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
683314|NCT01959412|P1|Participant Flow|Sequence 4 (Ind 150 μg)|indacaterol 150 μg, indacaterol 27.5 μg, indacaterol 75 μg, placebo indacaterol 55 μg indacaterol 37.5 μg Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
683315|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
683379|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683316|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
683317|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
683318|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
683319|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
683320|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
683321|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
683322|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
683323|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
683324|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
683325|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
683326|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
683327|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
683328|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
683329|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
683330|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
683380|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683331|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
683332|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
683333|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
683334|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
683335|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
683336|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
683337|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
683338|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
683339|NCT01959412|O6|Outcome|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
683340|NCT01959412|O5|Outcome|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
683341|NCT01959412|O4|Outcome|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
683342|NCT01959412|O3|Outcome|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
683343|NCT01959412|O2|Outcome|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
683344|NCT01959412|O1|Outcome|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
683345|NCT01959412|E6|Reported Event|Placebo|Placebo in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening
683381|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683346|NCT01959412|E5|Reported Event|Ind 27.5|Indacaterol 27.5 mcg in the morning + 27.5mcg in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later 150mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening
683347|NCT01959412|E4|Reported Event|Ind 37.5 μg|Indacaterol 37.5 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcgin the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening
683348|NCT01959412|E3|Reported Event|Ind 55 μg|Indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later 37.5 in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening
683349|NCT01959412|E2|Reported Event|Ind 75 μg|Indacaterol 75 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later 55mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo n the evening, 14 days later placebo in the morning + matching placebo in the evening
683350|NCT01959412|E1|Reported Event|Ind 150 μg|Indacaterol 150 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 27.5 mcg in the morning + 27.5 mcg in the evening, 14 days later 75 mcg in the morning + matching placebo in the evening, 14 days later placebo in the morning + matching placebo in the evening, 14 days later indacaterol 55 mcg in the morning + matching placebo in the evening, 14 days later indacaterol 37.5 mcg in the morning + matching placebo in the evening
683351|NCT01959035|B1|Baseline|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683352|NCT01959035|P1|Participant Flow|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month depending on the last dose that they had received in Study 14724A; 6 intramuscular (IM) injections starting at baseline
683353|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683354|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683355|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683356|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683357|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683358|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683359|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683360|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683361|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683362|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683363|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683364|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683365|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683366|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683367|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683368|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683369|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683370|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683371|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683372|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683373|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683374|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683375|NCT01959035|O1|Outcome|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683376|NCT01959035|E1|Reported Event|Aripiprazole Once-monthly|Aripiprazole once-monthly: 400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
683377|NCT01958827|B1|Baseline|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683378|NCT01958827|P1|Participant Flow|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683382|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683383|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683384|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683385|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683386|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683387|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683388|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683389|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683390|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683391|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683392|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683393|NCT01958827|O1|Outcome|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683394|NCT01958827|E1|Reported Event|Adalimumab 80 mg|All participants were to receive subcutaneous injections of open-label adalimumab 80 mg every other week from Week 0 to Week 50.
683395|NCT01958788|B1|Baseline|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
683396|NCT01958788|P1|Participant Flow|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683397|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683398|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683399|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683400|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683401|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683402|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683403|NCT01958788|O1|Outcome|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments.
683404|NCT01958788|E1|Reported Event|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty via behavioural experiments
683405|NCT01958645|B4|Baseline|Total|Total of all reporting groups
683406|NCT01958645|B3|Baseline|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
683407|NCT01958645|B2|Baseline|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
683408|NCT01958645|B1|Baseline|Placebo|Placebo (Saline solution for infusion)
683409|NCT01958645|P3|Participant Flow|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
683410|NCT01958645|P2|Participant Flow|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
683411|NCT01958645|P1|Participant Flow|Placebo|Placebo (Saline solution for infusion)
683412|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
683413|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
683414|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
683415|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
683416|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
683417|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
683418|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
683419|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
683420|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
683421|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
683422|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
683423|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
683424|NCT01958645|O4|Outcome|Placebo Dose 2|Placebo dose 2 (Saline solution for infusion)
683425|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
683426|NCT01958645|O2|Outcome|MEDI8111 Dose 1|MEDI8111 dose 1 (Lyophilisate for solution for infusion, 30 mg)
683427|NCT01958645|O1|Outcome|Placebo Dose 1|Placebo dose 1 (Saline solution for infusion)
683428|NCT01958645|O3|Outcome|MEDI8111 Dose 2|MEDI8111 dose 2 (Lyophilisate for solution for infusion, 30 mg)
683662|NCT01957579|O3|Outcome|8 mg/kg (MM)|MM patients in MEDI-551 8 mg/kg cohort
683436|NCT01958619|B3|Baseline|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683437|NCT01958619|B2|Baseline|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683438|NCT01958619|B1|Baseline|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683439|NCT01958619|P4|Participant Flow|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683440|NCT01958619|P3|Participant Flow|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683441|NCT01958619|P2|Participant Flow|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683442|NCT01958619|P1|Participant Flow|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683443|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683444|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683445|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683446|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683447|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683448|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683449|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683450|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683451|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683452|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683453|NCT01958619|O4|Outcome|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683454|NCT01958619|O3|Outcome|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683455|NCT01958619|O2|Outcome|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683456|NCT01958619|O1|Outcome|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683457|NCT01958619|E4|Reported Event|Treatment D: 800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683458|NCT01958619|E3|Reported Event|Treatment C: 960mg PQP Granules & 800mg OZ439 + TPGS|Piperaquine phosphate granules for oral solution (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683459|NCT01958619|E2|Reported Event|Treatment B: 960mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (960mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683460|NCT01958619|E1|Reported Event|Treatment A: 1440mg PQP Tablets & 800mg OZ439 + TPGS|Piperaquine phosphate tablets (1440mg) and OZ439 (800mg) + TPGS granules for oral suspension under fasted conditions.
683461|NCT01958606|B3|Baseline|Total|Total of all reporting groups
683462|NCT01958606|B2|Baseline|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683463|NCT01958606|B1|Baseline|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683464|NCT01958606|P2|Participant Flow|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683465|NCT01958606|P1|Participant Flow|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683466|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683467|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683468|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683469|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
724305|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
683470|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683471|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683472|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683473|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683474|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683475|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683476|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683477|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683478|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683479|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683480|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683481|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683482|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683483|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683484|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683485|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683486|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683487|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683488|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683489|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683490|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683491|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683492|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683493|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683494|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683495|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683496|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683497|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683498|NCT01958606|O2|Outcome|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683499|NCT01958606|O1|Outcome|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683500|NCT01958606|E2|Reported Event|Traditional Aerobic Training|"Moderate intensity continuous aerobic exercise on a treadmill~Traditional Aerobic Training: Moderate intensity continuous aerobic exercise on a treadmill"
683501|NCT01958606|E1|Reported Event|High-intensity Interval Training (HIT)|"Treadmill exercise using bursts of concentrated effort alternated with recovery periods~High-intensity interval training (HIT): Treadmill exercise using bursts of concentrated effort alternated with recovery periods"
683502|NCT01958346|B3|Baseline|Total|Total of all reporting groups
683503|NCT01958346|B2|Baseline|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
683504|NCT01958346|B1|Baseline|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
683505|NCT01958346|P2|Participant Flow|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
683506|NCT01958346|P1|Participant Flow|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
683507|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
683508|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
683509|NCT01958346|O2|Outcome|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
683510|NCT01958346|O1|Outcome|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
683511|NCT01958346|E2|Reported Event|Fiberoptic Intubation With Lingual Traction|"Lingual Traction: The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.~Fiberoptic Intubation"
683512|NCT01958346|E1|Reported Event|Fiberoptic Intubation Alone|"Sham: Standard of care fiberoptic intubation without any additional experimental maneuvers~Fiberoptic Intubation"
683513|NCT01958164|B3|Baseline|Total|Total of all reporting groups
683514|NCT01958164|B2|Baseline|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
683515|NCT01958164|B1|Baseline|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683516|NCT01958164|P2|Participant Flow|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
683517|NCT01958164|P1|Participant Flow|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683518|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683519|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
683520|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683521|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
683522|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683523|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
683524|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683525|NCT01958164|O2|Outcome|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
683526|NCT01958164|O1|Outcome|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683527|NCT01958164|E2|Reported Event|Saline Solution + Actilyse|Patients received one dose of saline solution (NaCl 0.9% - 2ml), administered intravenously, at time 0. A first dose of Actilyse 2mg/2ml was administered intravenously to patients at 120 minutes if central venous access device (CVAD) function had not been restored.
683663|NCT01957579|O2|Outcome|4 mg/kg (MM)|MM patients in MEDI-551 4 mg/kg cohort
683528|NCT01958164|E1|Reported Event|Actilyse|Patients received one dose of Actilyse 2mg/2ml, administered intravenously, at time 0. A second dose was administered at 120 minutes if central venous access device (CVAD) function had not been restored.
683529|NCT01958060|B7|Baseline|Total|Total of all reporting groups
683530|NCT01958060|B6|Baseline|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683531|NCT01958060|B5|Baseline|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683532|NCT01958060|B4|Baseline|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683533|NCT01958060|B3|Baseline|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683534|NCT01958060|B2|Baseline|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683535|NCT01958060|B1|Baseline|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
683536|NCT01958060|P6|Participant Flow|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683537|NCT01958060|P5|Participant Flow|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683538|NCT01958060|P4|Participant Flow|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683539|NCT01958060|P3|Participant Flow|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683540|NCT01958060|P2|Participant Flow|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683541|NCT01958060|P1|Participant Flow|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
683542|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683543|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683544|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683545|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683546|NCT01958060|O1|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683547|NCT01958060|O4|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683548|NCT01958060|O3|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683549|NCT01958060|O2|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683550|NCT01958060|O1|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683551|NCT01958060|O6|Outcome|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683552|NCT01958060|O5|Outcome|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683553|NCT01958060|O4|Outcome|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683554|NCT01958060|O3|Outcome|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683555|NCT01958060|O2|Outcome|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683556|NCT01958060|O1|Outcome|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
683557|NCT01958060|E6|Reported Event|BI 1034020 (100 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683558|NCT01958060|E5|Reported Event|BI 1034020 (50 mg/25 mL - iv)|Single dose administration of BI 1034020 (50 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683559|NCT01958060|E4|Reported Event|BI 1034020 (20 mg/25 mL - iv)|Single dose administration of BI 1034020 (20 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683560|NCT01958060|E3|Reported Event|BI 1034020 (10 mg/25 mL - iv)|Single dose administration of BI 1034020 (10 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683561|NCT01958060|E2|Reported Event|BI 1034020 (5 mg/25 mL - iv)|Single dose administration of BI 1034020 (5 mg) diluted with 25mL solution for intravenous (iv) infusion in the morning.
683562|NCT01958060|E1|Reported Event|Placebo|Single dose administration of placebo to BI 1034020 through solution for intravenous (iv) infusion in the morning.
683563|NCT01958021|B3|Baseline|Total|Total of all reporting groups
683564|NCT01958021|B2|Baseline|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
683565|NCT01958021|B1|Baseline|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
683664|NCT01957579|O1|Outcome|2 mg/kg (MM)|MM patients in MEDI-551 2 mg/kg cohort
683665|NCT01957579|O4|Outcome|12 mg/kg (CLL)|CLL patients in MEDI-551 12 mg/kg cohort
683566|NCT01958021|P2|Participant Flow|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
683567|NCT01958021|P1|Participant Flow|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
683568|NCT01958021|O2|Outcome|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
683569|NCT01958021|O1|Outcome|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
683570|NCT01958021|O2|Outcome|Placebo + Letrozole|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
683571|NCT01958021|O1|Outcome|LEE011 + Letrozole|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
683572|NCT01958021|E2|Reported Event|Placebo + Letrozole 2.5mg|Matching ribociclib placebo, control drug administered orally (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 placebo QD + 2.5 mg letrozole
683573|NCT01958021|E1|Reported Event|Ribociclib 600mg + Letrozole 2.5mg|LEE011 (ribociclib) oral (3 weeks on/ 1 week off) in combination with oral once daily letrozole. 600mg LEE011 QD + 2.5 mg letrozole QD
683574|NCT01958008|B5|Baseline|Total|Total of all reporting groups
683575|NCT01958008|B4|Baseline|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683576|NCT01958008|B3|Baseline|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683577|NCT01958008|B2|Baseline|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683578|NCT01958008|B1|Baseline|Placebo|Oral administration of Placebo matching BI 113608
683579|NCT01958008|P4|Participant Flow|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683580|NCT01958008|P3|Participant Flow|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683581|NCT01958008|P2|Participant Flow|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683582|NCT01958008|P1|Participant Flow|Placebo|Oral administration of Placebo matching BI 113608
683583|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683584|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683585|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683586|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683587|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683588|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683589|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683590|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683591|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683592|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683593|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683594|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683595|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683596|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683597|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683598|NCT01958008|O3|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683599|NCT01958008|O2|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683600|NCT01958008|O1|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683601|NCT01958008|O4|Outcome|BI 113608 50 mg|Oral administration of BI 113608 50 mg film coated tablets twice daily
683602|NCT01958008|O3|Outcome|BI 113608 25 mg|Oral administration of BI 113608 25 mg film coated tablets twice daily
683603|NCT01958008|O2|Outcome|BI 113608 10 mg|Oral administration of BI 113608 10 mg film coated tablets twice daily
683604|NCT01958008|O1|Outcome|Placebo|Oral administration of Placebo matching BI 113608
683605|NCT01958008|E4|Reported Event|50 mg Bid|Oral administration of BI 113608 50 mg film coated tablets twice daily
683606|NCT01958008|E3|Reported Event|25 mg Bid|Oral administration of BI 113608 25 mg film coated tablets twice daily
683607|NCT01958008|E2|Reported Event|10 mg Bid|Oral administration of BI 113608 10 mg film coated tablets twice daily
683608|NCT01958008|E1|Reported Event|Placebo|Oral administration of Placebo matching BI 113608
683609|NCT01957930|B3|Baseline|Total|Total of all reporting groups
683610|NCT01957930|B2|Baseline|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
683611|NCT01957930|B1|Baseline|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
683612|NCT01957930|P2|Participant Flow|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
683666|NCT01957579|O3|Outcome|8 mg/kg (CLL)|CLL patients in MEDI-551 8 mg/kg cohort
683667|NCT01957579|O2|Outcome|4 mg/kg (CLL)|CLL patients in MEDI-551 4 mg/kg cohort
683613|NCT01957930|P1|Participant Flow|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
683614|NCT01957930|O2|Outcome|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
683615|NCT01957930|O1|Outcome|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
683616|NCT01957930|E2|Reported Event|Standard-treatment|"Continuing with routine diabetes care~Standard treatment: Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months"
683617|NCT01957930|E1|Reported Event|Intensified Insulin Treatment|Intensified conventional insulin treatment: The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
683618|NCT01957865|B4|Baseline|Total|Total of all reporting groups
683619|NCT01957865|B3|Baseline|Control|Real-time adherence monitoring only (no SMS)
683620|NCT01957865|B2|Baseline|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
683621|NCT01957865|B1|Baseline|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
683622|NCT01957865|P3|Participant Flow|Control|Real-time adherence monitoring only (no SMS)
683623|NCT01957865|P2|Participant Flow|Triggered SMS, Real-time Monitoring|SMS were sent for missed doses throughout the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
683624|NCT01957865|P1|Participant Flow|Fixed SMS, Real-time Monitoring|SMS were sent daily for one month, then weekly for two months and then after missed doses for the remainder of the study. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.
683625|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
683626|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence"
683627|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
683628|NCT01957865|O3|Outcome|Control|Real-time adherence monitoring only (no SMS)
683629|NCT01957865|O2|Outcome|Triggered SMS, Real-time Monitoring|"Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
683630|NCT01957865|O1|Outcome|Fixed SMS, Real-time Monitoring|"Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~The Wisepill system automatically captured and reported each time the device was opened as a proxy for the participant's adherence."
683631|NCT01957865|E3|Reported Event|Control|Real-time adherence monitoring only (no SMS)
683632|NCT01957865|E2|Reported Event|Triggered SMS, Real-time Monitoring|"Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Triggered SMS, real-time monitoring: SMS reminders were sent as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
683633|NCT01957865|E1|Reported Event|Fixed SMS, Real-time Monitoring|"SMS were sent daily for one month, then weekly for two months. Participants had real-time adherence monitoring and social supporters were notified of gaps in adherence of 48+ hours in the last six months of the study.~Fixed SMS, real-time monitoring: SMS reminders were sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system automatically captured and reported each time the device is opened as a proxy for the participant's adherence."
683634|NCT01957761|B1|Baseline|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
683635|NCT01957761|P1|Participant Flow|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
683636|NCT01957761|O1|Outcome|Clostridium Difficile Infection|All patients with CDI between 12/2012 and 12/2013 were retrospectively reviewed.
683637|NCT01957761|E1|Reported Event|Clostridium Difficile Infection|
683638|NCT01957657|B1|Baseline|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683668|NCT01957579|O1|Outcome|2 mg/kg (CLL)|CLL patients in MEDI-551 2 mg/kg cohort
683669|NCT01957579|O4|Outcome|12 mg/kg (DLBCL)|DLBCL patients in MEDI-551 12 mg/kg cohort
683639|NCT01957657|P1|Participant Flow|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir, immediate release tablet, plus faldaprevir, soft gelatin capsule, were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir, qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683640|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683641|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683642|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683643|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683644|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683645|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683646|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683647|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683648|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683649|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683650|NCT01957657|O1|Outcome|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683651|NCT01957657|E1|Reported Event|Deleobuvir + Faldaprevir, Mild Renal Impairment|"Multiple doses of deleobuvir plus faldaprevir were planned to be administered over 4 days to patients with mild renal impairment.~Administration of 600 mg deleobuvir bid and 120 mg faldaprevir qd on Days 1 to 3 (with a single loading dose of 240 mg faldaprevir qd on Day 1) and 600 mg deleobuvir qd and faldaprevir 120 mg qd on Day 4.~All four patients had mild renal impairment, i.e., estimated glomerular filtration rate (eGFR) of 60-89 mL/min."
683652|NCT01957579|B5|Baseline|Total|Total of all reporting groups
683653|NCT01957579|B4|Baseline|12 mg/kg|MEDI-551 12 mg/kg
683654|NCT01957579|B3|Baseline|8 mg/kg|MEDI-551 8 mg/kg
683655|NCT01957579|B2|Baseline|4 mg/kg|MEDI-551 4 mg/kg
683656|NCT01957579|B1|Baseline|2 mg/kg|MEDI-551 2mg/kg
683657|NCT01957579|P4|Participant Flow|12 mg/kg|MEDI-551 12 mg/kg
683658|NCT01957579|P3|Participant Flow|8 mg/kg|MEDI-551 8 mg/kg
683659|NCT01957579|P2|Participant Flow|4 mg/kg|MEDI-551 4 mg/kg
683660|NCT01957579|P1|Participant Flow|2 mg/kg|MEDI-551 2 mg/kg
683674|NCT01957579|O3|Outcome|8 mg/kg (FL)|FL patients in MEDI-551 8 mg/kg cohort
683675|NCT01957579|O2|Outcome|4 mg/kg (FL)|FL patients in MEDI-551 4 mg/kg cohort
683676|NCT01957579|O1|Outcome|2 mg/kg (FL)|FL patients in MEDI-551 2 mg/kg cohort
683677|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683678|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683679|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683680|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683681|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683682|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683683|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683684|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683685|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683686|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683687|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683688|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683689|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683690|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683691|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683692|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683693|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683694|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683695|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683696|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683697|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683698|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683699|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683700|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683701|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683702|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683703|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683704|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683705|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683706|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683707|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683708|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683709|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683710|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683711|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683712|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683713|NCT01957579|O1|Outcome|MEDI-551|MEDI-551 2, 4, 8 and 12 mg/kg were evaluated
683714|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683715|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683716|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683717|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683718|NCT01957579|O4|Outcome|12 mg/kg|MEDI-551 12 mg/kg
683719|NCT01957579|O3|Outcome|8 mg/kg|MEDI-551 8 mg/kg
683720|NCT01957579|O2|Outcome|4 mg/kg|MEDI-551 4 mg/kg
683721|NCT01957579|O1|Outcome|2 mg/kg|MEDI-551 2 mg/kg
683722|NCT01957579|E4|Reported Event|12 mg/kg|MEDI-551 12 mg/kg
683723|NCT01957579|E3|Reported Event|8 mg/kg|MEDI-551 8 mg/kg
683724|NCT01957579|E2|Reported Event|4 mg/kg|MEDI-551 4 mg/kg
683725|NCT01957579|E1|Reported Event|2 mg/kg|MEDI-551 2mg/kg
683726|NCT01957553|B1|Baseline|All Subjects|baseline data are summarized for all subjects
683727|NCT01957553|P2|Participant Flow|Treatment Seqence 2; First SenSura the Coloplast Test Product|"Subjects first allocated to SenSura will after cross-over test Coloplast Test product~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
683728|NCT01957553|P1|Participant Flow|Treatment Sequence 1, First Coloplast Test Product, the SenSur|"Subjects first allocated to Coloplast Test product will after cross-over test SenSura~Coloplast test product: Coloplast test product is a newly developed 2-piece ostomy appliance~SenSura: SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S"
683729|NCT01957553|O2|Outcome|SenSura|
683730|NCT01957553|O1|Outcome|Coloplast Test Product|
683731|NCT01957553|E2|Reported Event|SenSura|Safety data for subjects exposed to SenSura
683732|NCT01957553|E1|Reported Event|Test Product|Safety data for subjects exposed to the test product
683733|NCT01957488|B1|Baseline|All Subjects|
683734|NCT01957488|P6|Participant Flow|Test 2/Test 1/SenSura|"The subjects in this group test the following in the order described below:~Test 2~Test 1~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
683735|NCT01957488|P5|Participant Flow|Test 2/SenSura/Test 1|"The subjects in this group test the following in the order described below:~Test 2~SenSura (the comparator)~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
683736|NCT01957488|P4|Participant Flow|Test 1/Test 2/SenSura|"The subjects in this group test the following in the order described below:~Test 1~Test 2~SenSura (the comparator)~The products are single use products which in average are removed and re-applyed every1-2nd day."
683737|NCT01957488|P3|Participant Flow|Test 1/SenSura/Test 2|"The subjects in this group test the following in the order described below:~Test 1~SenSura (the comparator)~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
683738|NCT01957488|P2|Participant Flow|SenSura/Test 2/Test 1|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 2~Test 1~The products are single use products which in average are removed and re-applyed every1-2nd day."
683739|NCT01957488|P1|Participant Flow|SenSura/Test 1/Test 2|"The subjects in this group test the following in the order described below:~SenSura (the comparator)~Test 1~Test 2~The products are single use products which in average are removed and re-applyed every1-2nd day."
683740|NCT01957488|O3|Outcome|SenSura|Fraction of baseplates with No leakage/Seeping under the baseplate for subjects testing SenSura
683741|NCT01957488|O2|Outcome|Test 2|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 2
683742|NCT01957488|O1|Outcome|Test 1|Fraction of baseplates with No leakage/seeping under the baseplate for subjects testing Coloplast Test 1
683743|NCT01957488|E3|Reported Event|SenSura|Subjects testing SenSura
683744|NCT01957488|E2|Reported Event|Test 2|Subjects testing Coloplast Test 2
683745|NCT01957488|E1|Reported Event|Test 1|Subjects testing Coloplast Test 1
683746|NCT01957475|B1|Baseline|All Subjects|
683747|NCT01957475|P2|Participant Flow|First Coloplast Test Product Y, Then Coloplast Test Product Z|"The subjects first test test product Y and after cross-over test product Z~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
683748|NCT01957475|P1|Participant Flow|First Coloplast Test Product Z; Then Coloplast Test Product Y|"The subjects first test Coloplast Test product Z and after cross-over Coloplast Test product Y~Coloplast Test product Y: Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance~Coloplast Test product Z: Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance"
683749|NCT01957475|O2|Outcome|Test Z|Results from the subjects testing Coloplast Test Y
683750|NCT01957475|O1|Outcome|Test Y|Results from the subjects testing Coloplast Test Y
683751|NCT01957475|E2|Reported Event|Test Z|Results from the subjects testing Coloplast Test Y
683752|NCT01957475|E1|Reported Event|Test Y|Results from the subjects testing Coloplast Test Y
683753|NCT01957462|B1|Baseline|All Subjects|
683754|NCT01957462|P2|Participant Flow|First Coloplast Test X, Then Coloplast Test V|"The subjects test the two experimental Coloplast products in a randomised order: Coloplast Test product X and after cross over Coloplast Test product V~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
683755|NCT01957462|P1|Participant Flow|FirstColplast Test V, Then Coloplast Test X|"The subject tests two experimental coloplast products in a randomised order. Coloplast Test product V and after cross over ColoplastTest product X~Coloplast Test V: Coloplast Test product V is a newly developed 1-piece ostomy appliance~Coloplast Test X: Coloplast Test X is a newly developed 1-piece ostomy appliance"
683756|NCT01957462|O2|Outcome|Test X|the results presented for the subjects testing Test X
683757|NCT01957462|O1|Outcome|Test V|The results presented for the subjects testing Coloplast Test V
683758|NCT01957462|E2|Reported Event|Test X|the results presented for the subjects testing Test X
683759|NCT01957462|E1|Reported Event|Test V|The results presented for the subjects testing Coloplast Test V
683760|NCT01957410|B1|Baseline|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
683761|NCT01957410|P1|Participant Flow|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
683762|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
683763|NCT01957410|O1|Outcome|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
683764|NCT01957410|E1|Reported Event|Ketamine IV 0.5mg/kg|Participants received a single ketamine 0.5 milligram per kilogram (mg/kg) dose as a continuous Intravenous (IV) infusion over 40 minutes by use of an electronic syringe infusion pump on Day 1. Participants who responded continued the open-label treatment phase through Day 28 or until relapse, whichever occurred first. An additional single IV dose of ketamine 0.5 mg/kg was available during an optional open label treatment phase.
683765|NCT01957397|B1|Baseline|Overall Population|
683766|NCT01957397|P2|Participant Flow|1st Coloplast Test 2 2nd Coloplast Test 1 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
683767|NCT01957397|P1|Participant Flow|1st Coloplast Test 1,2nd Coloplast Test 2 3rd Coloplast Test 3|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
683768|NCT01957397|O4|Outcome|Baseline - Own Product|The subjects test own product to measure their baseline leakage
683769|NCT01957397|O3|Outcome|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
683807|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
683808|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
683809|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683770|NCT01957397|O2|Outcome|Coloplast Test 2|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test 2 first and thereafter Coloplast Test 1~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
683771|NCT01957397|O1|Outcome|Coloplast Test 1|"The subjects are randomised to two arms~In both arms the subjects start measuring the performance of own product to collect baseline data.~In this arm the subjects are randomised to test Coloplast Test1 first and thereafter Coloplast Test 2~Finally the all subject test Coloplast Test 3~Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance~Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance"
683772|NCT01957397|E4|Reported Event|Baseline - Own Product|The subjects test own product to measure their baseline leakage
683773|NCT01957397|E3|Reported Event|Coloplast Test 3|Coloplast Test 3: Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
683774|NCT01957397|E2|Reported Event|Coloplast Test 2|Coloplast Test 2: Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
683775|NCT01957397|E1|Reported Event|Coloplast Test 1|Coloplast Test 1: Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
683776|NCT01957384|B1|Baseline|All Subjects|
683777|NCT01957384|P6|Participant Flow|First Standard Care, Then Test Product 2, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 2~and thereafter~1) Coloplast Test product 1"
683778|NCT01957384|P5|Participant Flow|First Standard Care, Then Test Product 1, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Coloplast Test product 2"
683779|NCT01957384|P4|Participant Flow|First Test Product 2; Then Standard Care, Then Test Product 1|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 1"
683780|NCT01957384|P3|Participant Flow|First Test Product 2, Then Test Product 1, Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 2 are randomised to secondly test~1) Coloplast Test product 1~and thereafter~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)"
683781|NCT01957384|P2|Participant Flow|First Test Product 1, Then Standard Care, Then Test Product 2|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~1) Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)~and thereafter~1) Coloplast Test product 2"
683782|NCT01957384|P1|Participant Flow|First Test Product 1, Then Test Product 2;Then Standard Care|"The subjects are randomised 1:1:1 into six possible treatment groups to ensure random allocation of treatment to periods.~Subjects first testing Coloplast Test product 1 are randomised to secondly test :~- Coloplast Test product 2~and thereafter~- Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)and thereafter Coloplast Test product 2"
683783|NCT01957384|O3|Outcome|Standard Care|leakage data from all Standard Care baseplates
683784|NCT01957384|O2|Outcome|Coloplast Test Product 2|Leakage data from all Test 2 baseplates
683785|NCT01957384|O1|Outcome|Coloplast Test Product 1|leakage data from all Test 1 baseplates
683786|NCT01957384|E3|Reported Event|Standard Care|data from all subjects who tested Standard Care baseplates
683787|NCT01957384|E2|Reported Event|Coloplast Test Product 2|data from all subjects who tested Test 2 baseplates
683788|NCT01957384|E1|Reported Event|Coloplast Test Product 1|data from all subjects who tested Test 1 baseplates
683789|NCT01957215|B3|Baseline|Total|Total of all reporting groups
683790|NCT01957215|B2|Baseline|Placebo Patch|Placebo patch was applied on the sprained ankle BID
683791|NCT01957215|B1|Baseline|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683792|NCT01957215|P2|Participant Flow|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
683793|NCT01957215|P1|Participant Flow|Indomethacin Patch|0.35% w/w Indomethacin patch was applied on the sprained ankle twice a day (BID).
683794|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
683795|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683796|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
683797|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683798|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
683799|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683800|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
683801|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683802|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
683803|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
683804|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
683805|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
683806|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
683810|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID.
683811|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID.
683812|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch to be applied on the sprained ankle BID
683813|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle BID
683814|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
683815|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683816|NCT01957215|O2|Outcome|Placebo Patch|Placebo patch was applied on the sprained ankle BID
683817|NCT01957215|O1|Outcome|Indomethacin Patch|Indomethacin patch was applied on the sprained ankle BID
683818|NCT01957215|E2|Reported Event|Placebo Patch|Placebo patch to be applied on the sprained ankle BID.
683819|NCT01957215|E1|Reported Event|Indomethacin Patch|Indomethacin patch to be applied on the sprained ankle twice a day (BID).
683820|NCT01957202|B1|Baseline|FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, Levo 200 µg, FF 100 μg/Levo 200 μg and placebo once daily (OD) in the morning as 2 nasal sprays (FF: 25 µg per spray, Levo: 50 μg per spray, FF/Levo: 25 μg/50 μg per spray) into each nostril for 8 days each, in a crossover design. Treatment was given in one of 18 sequences in Periods 1, 2, and 3, (with a minimum of a 14-day washout period between treatments): BCD, BAC, BCA, DAC, DCB, CDB, ADC, CAD, DCA, ACB, BDC, CBA, CBD, ACD, CAB, CDA, ABC, DBC (A, FF 100 μg; B, Levo 200 μg; C, FF 100 μg/Levo 200 μg; D, placebo). On Day 1 and Day 8 of each treatment period, participants were subjected to an allergen challenge in a Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit of 14-28 days after their last dose, and the overall duration for participation in the study (screening to follow-up) was 20 weeks.
683821|NCT01957202|P18|Participant Flow|Sequence 18: Placebo, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received placebo, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683822|NCT01957202|P17|Participant Flow|Sequence 17: FF 100 μg, Levo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, Levo 200 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683823|NCT01957202|P16|Participant Flow|Sequence 16: FF 100 μg/Levo 200 μg, Placebo, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, placeboμg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo µg OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683824|NCT01957202|P15|Participant Flow|Sequence 15: FF 100 μg/Levo 200 μg, FF 100 μg, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683825|NCT01957202|P14|Participant Flow|Sequence 14: FF 100 μg, FF 100 μg/Levo 200 μg, Placebo|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683826|NCT01957202|P13|Participant Flow|Sequence 13: FF 100 μg/Levo 200 μg, Levo 200 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683827|NCT01957202|P12|Participant Flow|Sequence 12: FF 100 μg/Levo 200 μg, Levo 200 μg, FF 100 μg|Participants received FF 100 μg/Levo 200 μg, Levo 200 µg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683828|NCT01957202|P11|Participant Flow|Sequence 11: Levo 200 μg, Placebo, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683829|NCT01957202|P10|Participant Flow|Sequence 10: FF 100 μg, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received FF 100 µg, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
684019|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
684020|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
683830|NCT01957202|P9|Participant Flow|Sequence 9: Placebo, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received placebo, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683831|NCT01957202|P8|Participant Flow|Sequence 8: FF 100 μg/Levo 200 μg, FF 100 μg, Placebo|Participants received FF 100 μg/Levo 200 μg, FF 100 µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683832|NCT01957202|P7|Participant Flow|Sequence 7: FF 100 μg, Placebo 200 μg, FF 100 μg/Levo 200 μg|Participants received FF 100 µg, placebo and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683833|NCT01957202|P6|Participant Flow|Sequence 6: FF 100 μg/Levo 200 μg, Placebo, Levo 200 μg|Participants received FF 100 μg/Levo 200 μg, placebo and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683834|NCT01957202|P5|Participant Flow|Sequence 5: Placebo, FF 100 μg/Levo 200 μg, Levo 200 μg|Participants received placebo, FF 100 μg/Levo 200 μg and Levo 200 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683835|NCT01957202|P4|Participant Flow|Sequence 4: Placebo, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received placebo, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the placebo OD in the morning as 2 nasal sprays and FF 100 µg OD in the morning as 2 nasal sprays and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683836|NCT01957202|P3|Participant Flow|Sequence 3: Levo 200 µg, FF 100 μg/Levo 200 μg, FF 100 μg|Participants received Levo 200 µg, FF 100 μg/Levo 200 μg and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683837|NCT01957202|P2|Participant Flow|Sequence 2: Levo 200 µg, FF 100 μg, FF 100 μg/Levo 200 μg|Participants received Levo 200 µg, FF 100 µg and FF 100 μg/Levo 200 μg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg OD in the morning as 2 nasal spray (50 μg per spray) and FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683838|NCT01957202|P1|Participant Flow|Sequence 1: Levo 200 µg, FF 100 μg/Levo 200 μg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), fluticasone furoate (FF) 100 μg/Levo 200 μg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 μg once daily (OD) in the morning as 2 nasal spray (50 μg per spray) and FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) and placebo OD in the morning as 2 nasal sprays into each nostril for 8 days. The three treatment periods were separated by a washout period of 14 to 28 days.
683839|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
683840|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
683841|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
683842|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
683843|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
683844|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
683845|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
683846|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
683847|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
683848|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
683849|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
683850|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
683851|NCT01957202|O4|Outcome|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
683852|NCT01957202|O3|Outcome|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
683853|NCT01957202|O2|Outcome|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
683854|NCT01957202|O1|Outcome|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
683855|NCT01957202|E4|Reported Event|FF 100 μg/Levo 200 μg|Participants received FF 100 μg/Levo 200 µg OD in the morning as 2 nasal sprays (25 µg/50 μg per spray) in each nostril for 8 days
683856|NCT01957202|E3|Reported Event|Levo 200 μg|Participants received Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) in each nostril for 8 days
683857|NCT01957202|E2|Reported Event|FF 100 μg|Participants received FF 100 µg OD in the morning as 2 nasal sprays (25 µg per spray) in each nostril for 8 days
683858|NCT01957202|E1|Reported Event|Placebo|Participants received placebo OD in the morning as 2 nasal sprays in each nostril for 8 days
683859|NCT01957163|B4|Baseline|Total|Total of all reporting groups
683860|NCT01957163|B3|Baseline|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683861|NCT01957163|B2|Baseline|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683862|NCT01957163|B1|Baseline|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683863|NCT01957163|P3|Participant Flow|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhaler followed by one inhalation of umeclidinium bromide 125 µg administered via a dry powder inhaler in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683864|NCT01957163|P2|Participant Flow|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg once- daily via a dry powder inhalerfollowed by one inhalation of umeclidinium bromide 62.5 µg administered via a dry powder inhaler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683865|NCT01957163|P1|Participant Flow|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 µg once-daily (OD) via a dry powder inhaler (DPI), followed by one inhalation of umeclidinium bromide (UMEC) matching placebo, administered via a dry powder inahler in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683866|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683867|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683868|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683869|NCT01957163|O3|Outcome|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683870|NCT01957163|O2|Outcome|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683871|NCT01957163|O1|Outcome|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683872|NCT01957163|E3|Reported Event|FF/VI 100/25 µg + UMEC 125 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 125 µg administered via a DPI in the morning for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683873|NCT01957163|E2|Reported Event|FF/VI 100/25 µg + UMEC 62.5 µg|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI followed by one inhalation of UMEC 62.5 µg administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
684018|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
683874|NCT01957163|E1|Reported Event|FF/VI 100/25 µg + Placebo|Participants received one inhalation of fluticasone furoate/vilanterol 100/25 µg OD via a DPI, followed by one inhalation of UMEC matching placebo, administered via a DPI in the morning for 12weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study, for symptomatic relief from COPD symptoms.
683875|NCT01957137|B1|Baseline|Subjects Who First Finished Unique Randomization Sequences|Baseline descriptions provided were based on 24 subjects who first finished unique randomization sequences, which are those subjects included in the primary analysis of the primary outcome.
683876|NCT01957137|P1|Participant Flow|All Study Participants|Thirty subjects were randomized to 1 of 24 sequences with 4 cycling settings: 2 subjects discontinued early with 1 due to an AE, and 1 due to consent withdrawal. Twenty-eight subjects completed the randomization sequences . After that all subjects went through no stimulation for approximately 4 weeks, which was not part of randomization.
683877|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
683878|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
683879|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
683880|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
683881|NCT01957137|O1|Outcome|No Stimulation|Following the randomized portion of the study, all subjects went through no stimulation for approximately 4 weeks.
683882|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
683883|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
683884|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
683885|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
683886|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
683887|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
683888|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
683889|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
683890|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
683891|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
683892|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
683893|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
683894|NCT01957137|O4|Outcome|Cycling Parameter #3|Subjects received cycling parameter #3 for approximately 4 weeks.
683895|NCT01957137|O3|Outcome|Cycling Parameter #2|Subjects received cycling parameter #2 for approximately 4 weeks.
683896|NCT01957137|O2|Outcome|Cycling Parameter #1|Subjects received cycling parameter #1 for approximately 4 weeks.
683897|NCT01957137|O1|Outcome|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
683898|NCT01957137|E5|Reported Event|No Stimulation|Subjects received no stimulation for approximately 4 weeks.
683899|NCT01957137|E4|Reported Event|Cycling Parameter #3|Subjects received Cycling Parameter #3 for approximately 4 weeks.
683900|NCT01957137|E3|Reported Event|Cycling Parameter #2|Subjects received Cycling Parameter #2 for approximately 4 weeks.
683901|NCT01957137|E2|Reported Event|Cycling Parameter #1|Subjects received Cycling Parameter #1 for approximately 4 weeks.
683902|NCT01957137|E1|Reported Event|Continuous|Subjects received continuous stimulation for approximately 4 weeks.
683903|NCT01957111|B3|Baseline|Total|Total of all reporting groups
683904|NCT01957111|B2|Baseline|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
683905|NCT01957111|B1|Baseline|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
683906|NCT01957111|P2|Participant Flow|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
683907|NCT01957111|P1|Participant Flow|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
683908|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
683909|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
683910|NCT01957111|O2|Outcome|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
683911|NCT01957111|O1|Outcome|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
683912|NCT01957111|E2|Reported Event|Good Sleepers|To be considered a good sleeper, participants had to report that they did not have difficulty falling asleep or staying asleep. A 15-minute criterion was used such that subjects had to report taking 15 minutes or less to fall asleep and spend 15 minutes or less awake during the night.
683913|NCT01957111|E1|Reported Event|Individuals With Insomnia|Participants with insomnia met the following Research Diagnostic Criteria for primary insomnia: subjective complaint of difficulty initiating or maintaining sleep, waking up too early or nonrestorative sleep, daytime consequences as a result of the poor sleep, duration of at least 1 month, sleep disturbance is not secondary to a medical or psychiatric condition based or the effects of a substance, as determined by clinical history. In order to exclude individuals with mild insomnia, insomnia had to occur on 3 or more nights per week for three months or longer. A 30-minute criterion was used such that subjects had to report taking 30 minutes or longer to fall asleep and/or spend 30 minutes awake during the night.
683914|NCT01956240|B3|Baseline|Total|Total of all reporting groups
683915|NCT01956240|B2|Baseline|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683916|NCT01956240|B1|Baseline|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683917|NCT01956240|P2|Participant Flow|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683918|NCT01956240|P1|Participant Flow|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683919|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683920|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683921|NCT01956240|O2|Outcome|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683922|NCT01956240|O1|Outcome|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683960|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683923|NCT01956240|E2|Reported Event|Subjects With Shoulder Pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683924|NCT01956240|E1|Reported Event|Asymptomatic Subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
683925|NCT01956097|B4|Baseline|Total|Total of all reporting groups
683926|NCT01956097|B3|Baseline|Placebo|"Placebo~Placebo"
683927|NCT01956097|B2|Baseline|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
683928|NCT01956097|B1|Baseline|HX106 590mg|"HX106 590mg/day~HX106 590mg"
683929|NCT01956097|P3|Participant Flow|Placebo|"Placebo~Placebo"
683930|NCT01956097|P2|Participant Flow|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
683931|NCT01956097|P1|Participant Flow|HX106 590mg|"HX106 590mg/day~HX106 590mg"
683932|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
683933|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
683934|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
683935|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
683936|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
683937|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
683938|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
683939|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
683940|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
683941|NCT01956097|O3|Outcome|Placebo|"Placebo~Placebo"
683942|NCT01956097|O2|Outcome|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
683943|NCT01956097|O1|Outcome|HX106 590mg|"HX106 590mg/day~HX106 590mg"
683944|NCT01956097|E3|Reported Event|Placebo|"Placebo~Placebo"
683945|NCT01956097|E2|Reported Event|HX106 1180mg|"HX106 1180mg/day~HX106 1180mg"
683946|NCT01956097|E1|Reported Event|HX106 590mg|"HX106 590mg/day~HX106 590mg"
683947|NCT01956032|B1|Baseline|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683948|NCT01956032|P1|Participant Flow|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683949|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683950|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683951|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683952|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683953|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683954|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683955|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683956|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683957|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683958|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683959|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
684016|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
684076|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
683961|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683962|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683963|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683964|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683965|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683966|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683967|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683968|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683969|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683970|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683971|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683972|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683973|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683974|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683975|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683976|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683977|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683978|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683979|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683980|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683981|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683982|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
684017|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
684077|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
683983|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683984|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683985|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683986|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683987|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683988|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683989|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683990|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683991|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683992|NCT01956032|O1|Outcome|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683993|NCT01956032|E1|Reported Event|Participants With Parkinson's Disease|Participants diagnosed with Parkinson's disease and have continued disabling motor complications despite optimized per-oral or other treatment regimens suitable for Duodopa treatment in accordance with the Swedish Summary of Products Characteristics.
683994|NCT01955720|B1|Baseline|Total Subjects Group|The total subjects group contains the following sub-groups: high dose (5 g idarucizumab), healthy, aged 45-64 yrs: high dose (5 g idarucizumab), healthy elderly, aged 65-80 yrs: high dose (5 g idarucizumab), mild renal impairment (RI), aged 45-80 yrs: high dose (2.5 g + 2.5 g idarucizumab), with moderate RI, aged 45-80 yrs: medium dose (2.5 g idarucizumab), healthy, aged 45-64 yrs: low dose (1 g idarucizumab), healthy elderly, aged 65-80 yrs: low dose (1 g idarucizumab), with mild RI, aged 45-80 yrs.
683995|NCT01955720|P6|Participant Flow|Placebo / 1 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 1g followed by dabigatran 220 mg plus Ida 1g (low dose)
683996|NCT01955720|P5|Participant Flow|1 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 1g followed by dabigatran 220 mg plus placebo 1g (low dose)
683997|NCT01955720|P4|Participant Flow|Placebo / 2.5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 2.5g followed by dabigatran 220 mg plus Ida 2.5g (medium dose)
683998|NCT01955720|P3|Participant Flow|2.5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus Ida 2.5g followed by dabigatran 220 mg plus placebo 2.5g (medium dose)
683999|NCT01955720|P2|Participant Flow|Placebo / 5 Ida|Subjects received dabigatran (DE) 220 mg plus placebo 5g followed by dabigatran 220 mg plus Ida 5g (high dose)
684000|NCT01955720|P1|Participant Flow|5 Ida / Placebo|Subjects received dabigatran (DE) 220 mg plus idarucizumab (Ida) 5g followed by dabigatran 220 mg plus placebo 5g (high dose)
684001|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
684002|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
684003|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
684004|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684005|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
684006|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684007|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
684008|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
684009|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
684010|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
684011|NCT01955720|O6|Outcome|150 mg/1 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
684012|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684013|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
684014|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684015|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
724306|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
684021|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
684022|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
684023|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
684024|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684025|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
684026|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
684027|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
684028|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684029|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
684030|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
684031|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
684032|NCT01955720|O15|Outcome|150 mg /Plc. 2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each plc. 2.5g, given 1 h apart.
684033|NCT01955720|O14|Outcome|150 mg /2*2.5g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused as 2 doses of each Ida 2.5g, given 1 h apart.
684034|NCT01955720|O13|Outcome|150 mg/Plc. 5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 5g
684035|NCT01955720|O12|Outcome|150 mg/5g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
684036|NCT01955720|O11|Outcome|150 mg/Plc. 1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/plc. 1g
684037|NCT01955720|O10|Outcome|150 mg/1g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 1g
684038|NCT01955720|O9|Outcome|220 mg/Plc. 5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 5g.
684039|NCT01955720|O8|Outcome|220 mg/5g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684040|NCT01955720|O7|Outcome|220 mg/Plc. 1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/plc. 1g.
684041|NCT01955720|O6|Outcome|220 mg/1g HS 65-80 Yrs|Healthy subjects (HS) elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
684042|NCT01955720|O5|Outcome|220 mg/Plc. 5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/plc. 5g.
684043|NCT01955720|O4|Outcome|220 mg/5g HS 45-64 Yrs|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g
684044|NCT01955720|O3|Outcome|220 mg/2.5g HS 45-64 Yrs Re-exposure|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
684045|NCT01955720|O2|Outcome|220 mg/Plc. 2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/ placebo(plc.) 2.5g.
684046|NCT01955720|O1|Outcome|220 mg/2.5g HS 45−64 Years|Healthy subjects (HS) mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
684047|NCT01955720|O8|Outcome|150 mg /2*2.5 g Moderate RI (CL 30-60)|Moderate RI (CL 30-60) with dabigatran (DE) 150 mg and were infused 2 doses of each Ida 2.5g, given 1 h apart.
684048|NCT01955720|O7|Outcome|150 mg/5 g Mild RI (CL 60-90)|Mild RI (CL 60-90) with dabigatran (DE) 150 mg/Ida 5g
684049|NCT01955720|O6|Outcome|150 mg/1 g Mild Renal Impairment (RI)|Mild RI (creatinine clearance [CL] 60-90) with dabigatran (DE) 150 mg/Ida 1g
684050|NCT01955720|O5|Outcome|220 mg/5 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684051|NCT01955720|O4|Outcome|220 mg/1 g HS 65-80 Yrs|HS elderly (65-80 yrs) with dabigatran (DE) 220 mg/Ida 1g.
684052|NCT01955720|O3|Outcome|220 mg/5 g HS 45-64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 5g.
684053|NCT01955720|O2|Outcome|220 mg/2.5 g HS 45-64 Yrs Re-exposure|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g and reexposured Ida in period 3
684054|NCT01955720|O1|Outcome|220 mg/2.5 g HS 45−64 Yrs|HS mid-age (45-64 yrs) with dabigatran (DE) 220 mg/Ida 2.5g.
684055|NCT01955720|O1|Outcome|On Treatment Group|during the treatment period.
684056|NCT01955720|O2|Outcome|Idarucizumab (Ida)|Idarucizumab (Ida).
684057|NCT01955720|O1|Outcome|Placebo|idarucizumab-matching placebo
684058|NCT01955720|E7|Reported Event|High (5g) Placebo Dose|Subjects with high (5g) placebo dose treatment
684059|NCT01955720|E6|Reported Event|Medium (2.5g) Placebo Dose|Subjects with medium (2.5g) placebo dose treatment
684060|NCT01955720|E5|Reported Event|Low (1g) Placebo Dose|Subjects with low (1g) placebo dose treatment
684061|NCT01955720|E4|Reported Event|High (5g) Idarucizumab Dose|Subjects with high (5g) idarucizumab dose treatment
684062|NCT01955720|E3|Reported Event|Medium (2.5g) Idarucizumab Dose|Subjects with medium (2.5g) idarucizumab dose treatment
684063|NCT01955720|E2|Reported Event|Low (1g) Idarucizumab Dose|Subjects with low 1g idarucizumab dose treatment
684064|NCT01955720|E1|Reported Event|Dabigatran Etexilate (DE)|subjects with Dabigatran etexilate (DE) treatment
684065|NCT01955707|B3|Baseline|Total|Total of all reporting groups
684066|NCT01955707|B2|Baseline|Natalizumab|300 mg single IV injection of natalizumab
684067|NCT01955707|B1|Baseline|Placebo|A single IV injection of placebo
684068|NCT01955707|P2|Participant Flow|Natalizumab|300 mg single IV injection of natalizumab
684069|NCT01955707|P1|Participant Flow|Placebo|A single intravenous (IV) injection of placebo
684070|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684071|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684072|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684073|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684074|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684075|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684078|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684079|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684080|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684081|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684082|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684083|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684084|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684085|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684086|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684087|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684088|NCT01955707|O2|Outcome|Natalizumab|300 mg single IV injection of natalizumab
684089|NCT01955707|O1|Outcome|Placebo|A single IV injection of placebo
684090|NCT01955707|E2|Reported Event|Natalizumab|300 mg single IV injection of natalizumab
684091|NCT01955707|E1|Reported Event|Placebo|A single IV injection of placebo
684092|NCT01955629|B1|Baseline|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684093|NCT01955629|P1|Participant Flow|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous (IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
684094|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684095|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684096|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684097|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684098|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684099|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684100|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684101|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684102|NCT01955629|O1|Outcome|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg IV infusion q3w in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant's refusal of further treatment.
684103|NCT01955629|E1|Reported Event|Aflibercept + XELOX (Oxaliplatin and Capecitabine)|Aflibercept 6 mg/kg intravenous(IV) infusion every 3 weeks (q3w) in combination with Oxaliplatin 100 mg/m^2 IV infusion q3w and Capecitabine 850 mg/m^2 twice daily orally (from Day 1 to Day 14 of each cycle), up to 6 cycles as induction therapy, followed by aflibercept 6 mg/kg IV infusion q3w as maintenance therapy up to DP or unacceptable toxicity or participant’s refusal of further treatment.
684104|NCT01955473|B6|Baseline|Total|Total of all reporting groups
684105|NCT01955473|B5|Baseline|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684106|NCT01955473|B4|Baseline|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684432|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684107|NCT01955473|B3|Baseline|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684108|NCT01955473|B2|Baseline|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684109|NCT01955473|B1|Baseline|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684110|NCT01955473|P5|Participant Flow|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684111|NCT01955473|P4|Participant Flow|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684112|NCT01955473|P3|Participant Flow|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684113|NCT01955473|P2|Participant Flow|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684114|NCT01955473|P1|Participant Flow|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684115|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684116|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684117|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684118|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684119|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684120|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684121|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684122|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684123|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684124|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684125|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684126|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684127|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684128|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684129|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684366|NCT01954628|P2|Participant Flow|Placebo|Placebo (matching AQX-1125 capsule), oral, once daily for 12 weeks. Placebo control. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
684130|NCT01955473|O2|Outcome|Part A and B Combined|All subjects who were included in Part A and Part B. Sym004 administered by intravenous infusion at a dose of 6 mg/kg weekly, or 9 mg/kg at Week 1 followed by a maintenance dose of 6 mg/kg weekly, or 12 mg/kg weekly, or 18 mg/kg biweekly in Part A or 12 mg/kg by intravenous infusion weekly in Part B until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684131|NCT01955473|O1|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684132|NCT01955473|O2|Outcome|Part A and B Combined|All subjects who were included in Part A and Part B. Sym004 administered by intravenous infusion at a dose of 6 mg/kg weekly, or 9 mg/kg at Week 1 followed by a maintenance dose of 6 mg/kg weekly, or 12 mg/kg weekly, or 18 mg/kg biweekly in Part A or 12 mg/kg by intravenous infusion weekly in Part B until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684133|NCT01955473|O1|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684134|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684135|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684136|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684137|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684138|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684139|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684140|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684141|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684142|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684143|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684144|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684145|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684146|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684147|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684148|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684149|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684150|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684151|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684152|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684153|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684154|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684155|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684156|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684157|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684158|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684159|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684160|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684161|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684162|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684163|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684164|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684165|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684166|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684167|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684168|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684169|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684170|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684171|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684172|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684173|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684174|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684175|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684176|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684177|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684178|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684179|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684180|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684181|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684182|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684183|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684184|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684185|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684186|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684187|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684188|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684189|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684190|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684191|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684192|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684193|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684194|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684195|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684196|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684197|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684198|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684199|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684200|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684201|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684202|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684203|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684204|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684205|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684206|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684207|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684208|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684209|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684210|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684211|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684212|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684213|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684214|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684215|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684216|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684217|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684218|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684219|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684220|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684221|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684222|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684223|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684224|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684225|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684226|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684227|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684228|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684229|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684230|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684231|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684232|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684233|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684234|NCT01955473|O1|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684235|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684236|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684237|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684238|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684239|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684240|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684241|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684242|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684243|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684244|NCT01955473|O4|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684245|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684246|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684247|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684248|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
724307|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
684249|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684250|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684251|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684252|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684253|NCT01955473|O5|Outcome|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684254|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684255|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684256|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684257|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684258|NCT01955473|O4|Outcome|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684259|NCT01955473|O3|Outcome|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684260|NCT01955473|O2|Outcome|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684261|NCT01955473|O1|Outcome|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684262|NCT01955473|E5|Reported Event|Part B: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684263|NCT01955473|E4|Reported Event|Part A: Sym004 18 mg/kg|Sym004 was administered at a dose of 18 mg/kg by intravenous infusion biweekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684264|NCT01955473|E3|Reported Event|Part A: Sym004 12 mg/kg|Sym004 was administered at a dose of 12 mg/kg by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684265|NCT01955473|E2|Reported Event|Part A: Sym004 9/6 mg/kg|Sym004 was administered at a dose of 9 mg/kg by intravenous infusion at Week 1 followed by a maintenance dose of 6 mg/kg weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684266|NCT01955473|E1|Reported Event|Part A: Sym004 6 mg/kg|Sym004 was administered at a dose of 6 milligram per kilogram (mg/kg) by intravenous infusion weekly until unacceptable toxicity, disease progression, or consent withdrawal, or until the subject met any of the criteria for treatment or trial discontinuation.
684267|NCT01955369|B1|Baseline|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
684268|NCT01955369|P1|Participant Flow|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
684269|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
684270|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
684271|NCT01955369|O1|Outcome|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
684430|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684272|NCT01955369|E1|Reported Event|Amyotrophic Lateral Sclerosis Patients|Patients were included into the registry if they had a new diagnosis of ALS, a minimum age of 18 years and lived in Rhineland-Palatinate for at least 6 months before date of diagnosis. Diagnosis was based upon the revised El Escorial criteria.
684273|NCT01955122|B3|Baseline|Total|Total of all reporting groups
684274|NCT01955122|B2|Baseline|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device) .
684275|NCT01955122|B1|Baseline|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
684276|NCT01955122|P2|Participant Flow|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
684277|NCT01955122|P1|Participant Flow|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
684278|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
684279|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
684280|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
684281|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
684282|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy.~Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
684283|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy.~Tandem Colonoscopy: Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order."
684284|NCT01955122|O2|Outcome|Group B|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
684285|NCT01955122|O1|Outcome|Group A|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
684286|NCT01955122|O2|Outcome|Standard Colonoscopy|procedures performed with the Standard
684287|NCT01955122|O1|Outcome|EndoRings Colonoscopy|procedures performed with the EndoRings
684288|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
684289|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
684290|NCT01955122|O2|Outcome|Group B|"Tandem Colonoscopy: Each patient will undergo 2 colonoscopy procedures:~an EndoRings™ colonoscopy followed immediately by a Standard view colonoscopy."
684291|NCT01955122|O1|Outcome|Group A|"Tandem Colonoscopy- Each patient will undergo 2 colonoscopy procedures:~a Standard view colonoscopy followed immediately by an EndoRings™ colonoscopy."
684292|NCT01955122|E2|Reported Event|Group B (Control Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: EndoRings™ colonoscopy followed by Standard colonoscopy (without using the EndoRings™ add-on device).
684293|NCT01955122|E1|Reported Event|A (Study Group)|Tandem Colonoscopy: Each patient will undergo a double procedure: Standard colonoscopy (without using the EndoRings™ add-on device) followed by EndoRings™ colonoscopy.
684294|NCT01955083|B3|Baseline|Total|Total of all reporting groups
684295|NCT01955083|B2|Baseline|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
684296|NCT01955083|B1|Baseline|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
684297|NCT01955083|P2|Participant Flow|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant."
684298|NCT01955083|P1|Participant Flow|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance)."
684299|NCT01955083|O2|Outcome|Percentage of Good Response at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percentage of good response at 3 months after surgery was calculated."
684300|NCT01955083|O1|Outcome|Percentage of Good Response at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percentage of good response was calculated."
684301|NCT01955083|O2|Outcome|Percent Change in B1-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
684302|NCT01955083|O1|Outcome|Percent Change in B1-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fmean (Hz) before and at 3 months after surgery was calculated."
684303|NCT01955083|O2|Outcome|Percent Change in B1-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
684304|NCT01955083|O1|Outcome|Percent Change in B1-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Fpeak (Hz) before and at 3 months after surgery was calculated."
684305|NCT01955083|O2|Outcome|Percent Change in B1-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
684306|NCT01955083|O1|Outcome|Percent Change in B1-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imean (dB) before and at 3 months after surgery was calculated."
684307|NCT01955083|O2|Outcome|Percent Change in B1-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
684308|NCT01955083|O1|Outcome|Percent Change in B1-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-Imax (dB) before and at 3 months after surgery was calculated."
684309|NCT01955083|O2|Outcome|Percent Change in B1-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
684310|NCT01955083|O1|Outcome|Percent Change in B1-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in B1-SI (event/hour) before and at 3 months after surgery was calculated."
684311|NCT01955083|O2|Outcome|Percent Change in Total-Fmean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
684312|NCT01955083|O1|Outcome|Percent Change in Total-Fmean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fmean (Hz) before and at 3 months after surgery was calculated."
684313|NCT01955083|O2|Outcome|Percent Change in Total-Fpeak at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
684314|NCT01955083|O1|Outcome|Percent Change in Total-Fpeak at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Fpeak (Hz) before and at 3 months after surgery was calculated."
684315|NCT01955083|O2|Outcome|Percent Change in Total-Imean at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
684316|NCT01955083|O1|Outcome|Percent Change in Total-Imean at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imean (dB) before and at 3 months after surgery was calculated."
684317|NCT01955083|O2|Outcome|Percent Change in Total-Imax at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
684318|NCT01955083|O1|Outcome|Percent Change in Total-Imax at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-Imax (dB) before and at 3 months after surgery was calculated."
684319|NCT01955083|O2|Outcome|Percent Change in Total-SI at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
684320|NCT01955083|O1|Outcome|Percent Change in Total-SI at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Percent change ([after value-before value]/[before value]*100) in Total-SI (event/hour) before and at 3 months after surgery was calculated."
684321|NCT01955083|O2|Outcome|Change in SOS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
724308|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
684322|NCT01955083|O1|Outcome|Change in SOS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in SOS score at 3 months after surgery was calculated."
684323|NCT01955083|O2|Outcome|Change in VAS Score at 3 Months After Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
684324|NCT01955083|O1|Outcome|Change in VAS Score at 3 Months After Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring. Mean change (after value-before value) in VAS score at 3 months after surgery was calculated."
684325|NCT01955083|E2|Reported Event|Pillar Implant|"Arm 1- Pillar implant (Study group):~15 subjects undergo pillar implant surgery of the soft palate for the treatment of snoring."
684326|NCT01955083|E1|Reported Event|Radiofrequency|"Arm 2- Radiofrequency (control group):~15 subjects undergo radiofrequency of the soft palate for the treatment of snoring."
684327|NCT01955044|B4|Baseline|Total|Total of all reporting groups
684328|NCT01955044|B3|Baseline|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
684329|NCT01955044|B2|Baseline|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684330|NCT01955044|B1|Baseline|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684331|NCT01955044|P3|Participant Flow|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
684332|NCT01955044|P2|Participant Flow|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684333|NCT01955044|P1|Participant Flow|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684334|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
684335|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684336|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684337|NCT01955044|O3|Outcome|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
684338|NCT01955044|O2|Outcome|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684339|NCT01955044|O1|Outcome|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684340|NCT01955044|E3|Reported Event|Placebo|"the placebo is a drop that will be administered to ELBW infants.~placebo"
684341|NCT01955044|E2|Reported Event|"Low Dose LCPUFA"|"the low dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684342|NCT01955044|E1|Reported Event|"High Dose LCPUFA"|"the high dose LCPUFA supplement is a drop that will be administered to ELBW infants.~LCPUFA supplement"
684343|NCT01955005|B3|Baseline|Total|Total of all reporting groups
684344|NCT01955005|B2|Baseline|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
684345|NCT01955005|B1|Baseline|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
684346|NCT01955005|P2|Participant Flow|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
684347|NCT01955005|P1|Participant Flow|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
684348|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
684349|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
684350|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
684351|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
684431|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684352|NCT01955005|O2|Outcome|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
684353|NCT01955005|O1|Outcome|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
684354|NCT01955005|E2|Reported Event|Internet Skills Training|"Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.~Internet Skills Training: Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information."
684355|NCT01955005|E1|Reported Event|My HealtheVet Training|"Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.~My HealtheVet Training: Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account."
684356|NCT01954745|B1|Baseline|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
684357|NCT01954745|P1|Participant Flow|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
684358|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
684359|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
684360|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
684361|NCT01954745|O1|Outcome|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
684362|NCT01954745|E1|Reported Event|Cabozantinib|"Patients will be treated with cabozantinib 60 mg daily administered orally continuously for 28-day cycles. Tumor assessments will be performed every 8 weeks until documented disease progression by RECIST criteria or drug intolerance.~Cabozantinib: Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment."
684363|NCT01954628|B3|Baseline|Total|Total of all reporting groups
684364|NCT01954628|B2|Baseline|Placebo|"1 x Placebo capsule daily~Placebo: Placebo control"
684365|NCT01954628|B1|Baseline|AQX-1125 (200 mg)|"1 x AQX-1125 capsule daily~AQX-1125: Synthetic SHIP1 activator"
684760|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684367|NCT01954628|P1|Participant Flow|AQX-1125 (200 mg)|AQX-1125 (200 mg capsule), oral once daily for 12 weeks. All standard of care treatments for COPD were permitted throughout the study with the exception of Roflumilast and Theophylline.
684368|NCT01954628|O3|Outcome|AQX-1125 Week 12|Week 12 PK Week 12 PK
684369|NCT01954628|O2|Outcome|AQX-1125 Week 4|AQX-1125 Week 4 PK
684370|NCT01954628|O1|Outcome|AQX-1125 Week 2|AQX-1125 Week 2 PK
684371|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
684372|NCT01954628|O1|Outcome|AQX-1125 (200mg)|1 x AQX-1125 capsule daily
684373|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
684374|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
684375|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
684376|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
684377|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
684378|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
684379|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
684380|NCT01954628|O1|Outcome|AQX-1125 (200 mg)|1 x AQX-1125 capsule daily
684381|NCT01954628|O2|Outcome|Placebo|1 x Placebo capsule daily
684382|NCT01954628|O1|Outcome|AQX-1125 (200mg)|1 x AQX-1125 capsule daily
684383|NCT01954628|E2|Reported Event|Placebo|"1 x Placebo capsule daily~Placebo: Placebo control"
684384|NCT01954628|E1|Reported Event|AQX-1125|"1 x AQX-1125 capsule daily~AQX-1125: Synthetic SHIP1 activator"
684385|NCT01954251|B3|Baseline|Total|Total of all reporting groups
684386|NCT01954251|B2|Baseline|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684387|NCT01954251|B1|Baseline|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684388|NCT01954251|P2|Participant Flow|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684389|NCT01954251|P1|Participant Flow|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684390|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684391|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684392|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684393|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684394|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684395|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684396|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684397|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684398|NCT01954251|O1|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684399|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684400|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684401|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684402|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684403|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684404|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684405|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684406|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684407|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684408|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684409|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684410|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684411|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684412|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684413|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684414|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684415|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684416|NCT01954251|O2|Outcome|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684417|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684418|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684419|NCT01954251|O1|Outcome|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684420|NCT01954251|E2|Reported Event|Control Group|The subjects assigned to the Control group received all vaccines separately: one injection of the FLU-D-QIV vaccine at the first visit, one injection of the HZ/su study vaccine at the third visit and a second injection of the HZ/su study vaccine at the fourth visit, all two months apart.
684421|NCT01954251|E1|Reported Event|GSK1437173A + GSK2321138A Group|The subjects assigned to the Co-Ad group received one injection of the FLU-D-QIV vaccine and one injection of the HZ/su study vaccine during the first visit and a second injection of the HZ/su study vaccine during the third visit, two months later.
684422|NCT01954160|B3|Baseline|Total|Total of all reporting groups
684423|NCT01954160|B2|Baseline|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684424|NCT01954160|B1|Baseline|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684425|NCT01954160|P2|Participant Flow|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684426|NCT01954160|P1|Participant Flow|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684427|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684428|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684429|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684433|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684434|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684435|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684436|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684437|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684438|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684439|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684440|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684441|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684442|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684443|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684444|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684445|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684446|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684447|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684448|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684449|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684450|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684451|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684452|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684453|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684454|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684455|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684456|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684457|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684458|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684459|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684460|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684461|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684761|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
724309|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
684765|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
684462|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684463|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684464|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684465|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684466|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684467|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684468|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684469|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684470|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684471|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684472|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684473|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684474|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684475|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684476|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684477|NCT01954160|O2|Outcome|Late Symplisity Renal Denervation|"Subjects following usual care until week 13 visit will then undergo Symplicity Renal Denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation: Renal denervation"
684478|NCT01954160|O1|Outcome|Early Symplisity Renal Denervation|"Subjects undergo Symplicity Renal Denervation within 2 weeks of baseline visit will follow usual care after week 13 visit~Symplicity Renal Denervation: Renal denervation"
684479|NCT01954160|O2|Outcome|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684480|NCT01954160|O1|Outcome|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684481|NCT01954160|E2|Reported Event|Late Renal Denervation|"Subjects undergo renal denervation within 2 weeks of Week 13 visit~Symplicity Renal Denervation System"
684482|NCT01954160|E1|Reported Event|Early Renal Denervation|"Subjects undergo renal denervation within 2 weeks of baseline visit~Symplicity Renal Denervation System"
684483|NCT01954121|B3|Baseline|Total Title|
684484|NCT01954121|B2|Baseline|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684485|NCT01954121|B1|Baseline|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684486|NCT01954121|P2|Participant Flow|Carbamazepine-IR|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684487|NCT01954121|P1|Participant Flow|Levetiracetam|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684488|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684489|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684490|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684491|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684492|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684493|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684494|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684495|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684496|NCT01954121|O2|Outcome|Carbamazepine-IR (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684497|NCT01954121|O1|Outcome|Levetiracetam (Per Protocol Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684498|NCT01954121|E2|Reported Event|Carbamazepine-IR (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Carbamazepine immediate-release (CBZ-IR) 200 mg qd. During Stabilization and Evaluation (27 weeks) Period CBZ-IR was taken bid 200 mg.
684499|NCT01954121|E1|Reported Event|Levetiracetam (Safety Set)|During the Up-Titration period (2 weeks), subjects initiated treatment at half the randomized target dose with Levetiracetam (LEV) 250 mg bid. During Stabilization and Evaluation Period (27 weeks) LEV was taken bid 500 mg.
684500|NCT01953354|B3|Baseline|Total|Total of all reporting groups
684501|NCT01953354|B2|Baseline|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684502|NCT01953354|B1|Baseline|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684503|NCT01953354|P2|Participant Flow|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684504|NCT01953354|P1|Participant Flow|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684505|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684506|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684507|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684508|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684509|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684510|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684511|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684512|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684513|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684514|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684515|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684516|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684517|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684518|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684519|NCT01953354|O2|Outcome|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684520|NCT01953354|O1|Outcome|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684521|NCT01953354|E2|Reported Event|Placebo|Participants were randomized to receive six doses of placebo in liquid suspension orally over a 10-week period.
684522|NCT01953354|E1|Reported Event|TSO 7500|Participants were randomized to receive six doses of 7500 viable, embryonated Trichuris suis ova (TSO) in liquid suspension orally over a 10-week period.
684523|NCT01953328|B9|Baseline|Total|Total of all reporting groups
684524|NCT01953328|B8|Baseline|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684525|NCT01953328|B7|Baseline|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684762|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684526|NCT01953328|B6|Baseline|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684527|NCT01953328|B5|Baseline|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684528|NCT01953328|B4|Baseline|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684529|NCT01953328|B3|Baseline|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684530|NCT01953328|B2|Baseline|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684531|NCT01953328|B1|Baseline|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684532|NCT01953328|P8|Participant Flow|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684533|NCT01953328|P7|Participant Flow|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684534|NCT01953328|P6|Participant Flow|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684535|NCT01953328|P5|Participant Flow|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684536|NCT01953328|P4|Participant Flow|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684537|NCT01953328|P3|Participant Flow|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684538|NCT01953328|P2|Participant Flow|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684539|NCT01953328|P1|Participant Flow|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684540|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684541|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684542|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684543|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684544|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684545|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684546|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684547|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684548|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684549|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684550|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684551|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684552|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684553|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684554|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684763|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
684555|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684556|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684557|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684558|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684559|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684560|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684561|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684562|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684563|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684564|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684565|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684566|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684567|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684568|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684569|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684570|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684571|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684572|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684573|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684574|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684575|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684576|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684577|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684578|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684579|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684580|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684581|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684582|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684583|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684584|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684585|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684586|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684587|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684588|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684589|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684590|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684591|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684592|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684593|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684594|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684595|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684596|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684597|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684598|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684599|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684600|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684601|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684602|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684603|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684604|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684605|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684606|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684607|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684608|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684609|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684610|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684611|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684612|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684613|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684614|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684615|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684616|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684617|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684618|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684619|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684620|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684621|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684622|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684623|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684624|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684625|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684626|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684627|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684628|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684629|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684630|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684631|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684632|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684633|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684634|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684635|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684636|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684637|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684638|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684639|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684640|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684641|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684642|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684643|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684644|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684645|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684646|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684647|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684648|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684649|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684650|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684651|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684652|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684653|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684654|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684655|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684656|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684657|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684658|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684659|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684660|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684661|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684662|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684663|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684664|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684665|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684666|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684667|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684668|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684669|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684670|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684671|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684672|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684673|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684674|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684675|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684676|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684677|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684678|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684679|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684680|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684681|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684682|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684683|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684684|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684685|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684686|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684687|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684688|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684689|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684690|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684691|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684692|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684693|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684694|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684695|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684696|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684697|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684698|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684699|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684700|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684701|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684702|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684703|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684704|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684705|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684706|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684707|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684708|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684709|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684710|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684711|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684712|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684713|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684714|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684715|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684716|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684717|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684718|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684719|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684720|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684721|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684722|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684723|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684724|NCT01953328|O8|Outcome|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684725|NCT01953328|O7|Outcome|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684726|NCT01953328|O6|Outcome|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684727|NCT01953328|O5|Outcome|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684728|NCT01953328|O4|Outcome|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684729|NCT01953328|O3|Outcome|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684730|NCT01953328|O2|Outcome|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684731|NCT01953328|O1|Outcome|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684732|NCT01953328|E8|Reported Event|A20 Evolocumab QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684733|NCT01953328|E7|Reported Event|A20 Evolocumab Q2W|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684764|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684734|NCT01953328|E6|Reported Event|A20 Placebo QM|Participants received atorvastatin 20 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month for 12 weeks.
684735|NCT01953328|E5|Reported Event|A20 Placebo Q2W|Participants received atorvastatin 20 mg (A20) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for 12 weeks.
684736|NCT01953328|E4|Reported Event|A5 Evolocumab QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for 12 weeks.
684737|NCT01953328|E3|Reported Event|A5 Evolocumab Q2W|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
684738|NCT01953328|E2|Reported Event|A5 Placebo QM|Participants received atorvastatin 5 mg daily during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every month (QM) for 12 weeks.
684739|NCT01953328|E1|Reported Event|A5 Placebo Q2W|Participants received atorvastatin 5 mg (A5) daily during the 4 week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
684740|NCT01953237|B3|Baseline|Total|Total of all reporting groups
684741|NCT01953237|B2|Baseline|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
684742|NCT01953237|B1|Baseline|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
684743|NCT01953237|P2|Participant Flow|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
684744|NCT01953237|P1|Participant Flow|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
684745|NCT01953237|O2|Outcome|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
684746|NCT01953237|O1|Outcome|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
684747|NCT01953237|E2|Reported Event|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
684748|NCT01953237|E1|Reported Event|Control|Individuals randomized to the control condition will be provided with a smartphone free of charge with unlimited use of the phone's voice and internet capabilities. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period. All participants will be contacted by research staff to trouble-shoot problems with the smartphone at the end of the first week, but will receive no additional contact from research staff until the end of the trial.
684749|NCT01953081|B3|Baseline|Total|Total of all reporting groups
684750|NCT01953081|B2|Baseline|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684751|NCT01953081|B1|Baseline|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
684752|NCT01953081|P2|Participant Flow|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684753|NCT01953081|P1|Participant Flow|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
684754|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684755|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
684756|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684757|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
684758|NCT01953081|O2|Outcome|Metoclopramide|Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline
684759|NCT01953081|O1|Outcome|TD-8954|TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours
684997|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
684766|NCT01953081|E2|Reported Event|Metoclopramide|"Metoclopramide 4 doses every 6 hours for 24 hours and 1 hour infusion of saline~Metoclopramide"
684767|NCT01953081|E1|Reported Event|TD-8954|"TD-8954 single infusion for 1 hour and 4 injections of saline every 6 hours~TD-8954"
684768|NCT01952834|B1|Baseline|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
684769|NCT01952834|P1|Participant Flow|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
684770|NCT01952834|O1|Outcome|Probiotic Supplementation|The measurement of IL-2 represents the change in IL-12 +/- standard deviation of the change following 6 weeks of probiotic supplementation.
684771|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
684772|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
684773|NCT01952834|O1|Outcome|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
684774|NCT01952834|E1|Reported Event|GoodBelly Probiotic and Vancomycin|"Good Belly Probiotic 2.7 oz Daily x 6 weeks Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~GoodBelly Probiotic: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days~Vancomycin: GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days"
684775|NCT01952691|B1|Baseline|Kinesiotaping|"all patients were implemented a kinesiotaping to align the hallux to correct position~kinesiotaping: correction method was used to align hallux."
684776|NCT01952691|P1|Participant Flow|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
684777|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
684778|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
684779|NCT01952691|O1|Outcome|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
684780|NCT01952691|E1|Reported Event|Kinesiotaping Implementation|"kinesiotaping was implemetedto all patients to align the hallux to correct position for 10 days. Each patient was re-assessed and the taping implementation was renewed on the 3rd, 7th and 10th days of the treatment.~kinesiotaping: correction method was used to align hallux's adduction position."
684781|NCT01952665|B3|Baseline|Total|Total of all reporting groups
684782|NCT01952665|B2|Baseline|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684783|NCT01952665|B1|Baseline|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684784|NCT01952665|P2|Participant Flow|Lotrafilcon B Then Comfilcon A|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684998|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685000|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
684785|NCT01952665|P1|Participant Flow|Comfilcon A Then Lotrafilcon B|Each subject randomized to wear either the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684786|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
684787|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684788|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684789|NCT01952665|O3|Outcome|Habitual Lens|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
684790|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684791|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684792|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684793|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684794|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684795|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684796|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684797|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684798|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684799|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684800|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684801|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684802|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684803|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684804|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684805|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684806|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684807|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684808|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684809|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684810|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684811|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684812|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684813|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684814|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684999|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
684815|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684816|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684817|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684818|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684819|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684820|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684821|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684822|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684823|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684824|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684825|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684826|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684827|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684828|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684829|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684830|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684831|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684832|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684833|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684834|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684835|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684836|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684837|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684838|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684839|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684840|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684841|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684842|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684843|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684844|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684845|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684846|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684847|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684848|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
684849|NCT01952665|O1|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684850|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684851|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684852|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684853|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684854|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684855|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684856|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684857|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684858|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684859|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684860|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684861|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684862|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684863|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684864|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684865|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684866|NCT01952665|O2|Outcome|Habitual Lenses|Subjects attended baseline visit wearing habitual lenses prior to dispense of study lens.
684867|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684868|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684869|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684870|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684871|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684872|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684873|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684874|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684941|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
684875|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684876|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684877|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684878|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684879|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684880|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684881|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684882|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684883|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684884|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684885|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684886|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684887|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684888|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684889|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684890|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684891|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684892|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684893|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684894|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684895|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684896|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684897|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684898|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684899|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684900|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684901|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684902|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684903|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684904|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684905|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684906|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684907|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684908|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684909|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684910|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684911|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684912|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684913|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684914|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684915|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684916|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684917|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684918|NCT01952665|O2|Outcome|Lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684919|NCT01952665|O1|Outcome|Comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
684920|NCT01952665|E2|Reported Event|Lotrafilcon B|"Daily wear soft contact lens lotrafilcon B~comfilcon A: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
684921|NCT01952665|E1|Reported Event|Comfilcon A|"Daily wear soft contact lens comfilcon A~lotrafilcon B: Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period."
684922|NCT01952600|B4|Baseline|Total|Total of all reporting groups
684923|NCT01952600|B3|Baseline|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
684924|NCT01952600|B2|Baseline|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
684925|NCT01952600|B1|Baseline|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
684926|NCT01952600|P3|Participant Flow|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
684927|NCT01952600|P2|Participant Flow|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
684928|NCT01952600|P1|Participant Flow|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
684929|NCT01952600|O3|Outcome|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
684930|NCT01952600|O2|Outcome|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
684931|NCT01952600|O1|Outcome|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
684932|NCT01952600|E3|Reported Event|Peritoneal Dialysis (PD)|Patients who have chronic kidney disease (CKD) and are currently on peritoneal dialysis.
684933|NCT01952600|E2|Reported Event|Hemodialysis (HD)|Patients who have chronic kidney disease (CKD) and are currently on hemodialysis.
684934|NCT01952600|E1|Reported Event|Chronic Kidney Disease (CKD)|Patients who have advanced chronic kidney disease, but are not currently on either hemodialysis (HD) or peritoneal dialysis (PD).
684935|NCT01952418|B3|Baseline|Total|Total of all reporting groups
684936|NCT01952418|B2|Baseline|"Large Monitor (32)"|"Endoscopists in this arm will perform colonoscopy using the large size video monitor (32)."
684937|NCT01952418|B1|Baseline|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
684938|NCT01952418|P2|Participant Flow|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
684939|NCT01952418|P1|Participant Flow|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
684940|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
684942|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
684943|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
684944|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
684945|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
684946|NCT01952418|O2|Outcome|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
684947|NCT01952418|O1|Outcome|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
684948|NCT01952418|E2|Reported Event|"Large Monitor (32)"|"Subjects randomized to this group will perform colonoscopy while viewing a large video monitor (32)."
684949|NCT01952418|E1|Reported Event|"Standard Monitor (24)"|"Endoscopists in this arm will perform colonoscopy using the standard size video monitor (24)."
684950|NCT01952366|B1|Baseline|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
684951|NCT01952366|P1|Participant Flow|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
684952|NCT01952366|O1|Outcome|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
684953|NCT01952366|O2|Outcome|Remission in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a remission (MADRS score of 9 or less) by the end of their hospital stay.
684954|NCT01952366|O1|Outcome|Response in Depressed Patients|Number of patients admitted to specialist health care service of old age psychiatry who demonstrated a response (50% improvement of the MADRS score) during stay in the hospital.
684955|NCT01952366|E1|Reported Event|Depressed Patients|Patients admitted to specialist health care service of old age psychiatry
684956|NCT01952301|B1|Baseline|Xenogeneic Collagen Matrix Versus Free Gingival Graft|free gingival graft versus a xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
684957|NCT01952301|P1|Participant Flow|XCM Versus FGG|xenogeneic collagen matrix versus free gingival graft
684958|NCT01952301|O2|Outcome|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap to generate keratinized tissue
684959|NCT01952301|O1|Outcome|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
684960|NCT01952301|E2|Reported Event|Xenogeneic Collagen Matrix|xenogeneic collagen matrix over an apically positioned flap used to generate keratinized tissue
684961|NCT01952301|E1|Reported Event|Free Gingival Graft|free gingival graft over an apically positioned flap used to generate keratinized tissue
684962|NCT01952145|B3|Baseline|Total|Total of all reporting groups
684963|NCT01952145|B2|Baseline|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684964|NCT01952145|B1|Baseline|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684965|NCT01952145|P2|Participant Flow|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684966|NCT01952145|P1|Participant Flow|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684967|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684993|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
684994|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
684995|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
684996|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
724310|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
684968|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684969|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684970|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684971|NCT01952145|O2|Outcome|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684972|NCT01952145|O1|Outcome|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684973|NCT01952145|E2|Reported Event|Insulin Glargine (IGlar)|Eligible subjects received IGlar OD subcutaneously for a duration of 26 weeks. The treatment started with dose equal to the pre-trial daily dose (dose-to-dose switch), after which the dose was titrated according to the specified titration algorithm aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). No predefined maximum dose was specified for IGlar. The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684974|NCT01952145|E1|Reported Event|Insulin Degludec/Liraglutide (IDegLira)|Eligible subjects received IDegLira once daily (OD) subcutaneously for a duration of 26 weeks. The starting dose of IDegLira was 16 dose steps (16 units IDeg/0.6 mg liraglutide) and was titrated according to a predefined titration algorithm with a maximum dose of 50 dose steps (50 units IDeg/1.8 mg liraglutide). Adjustment of the dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days. Adjustments were made in increments or decrements of 2 dose steps, aiming at a fasting glycaemic target of 4.0−5.0 mmol/L (71−90 mg/dL). That is, the adjustments were +2 or -2 if the mean of 3 pre-breakfast SMPG values were >5.0 mmol/L (or >90 mg/dL) and <4.0 mmol/L (or <71 mg/dL) respectively. No adjustment was done when the mean of 3 pre-breakfast SMPG values were 4.0 - 5.0 mmol/L (or 71-90 mg/dL). The subjects continued with pre-trial doses of metformin, unless there was a safety concern.
684975|NCT01952080|B5|Baseline|Total|Total of all reporting groups
684976|NCT01952080|B4|Baseline|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
684977|NCT01952080|B3|Baseline|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
684978|NCT01952080|B2|Baseline|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
684979|NCT01952080|B1|Baseline|Standard of Care|SOC- no teduglutide therapy
684980|NCT01952080|P4|Participant Flow|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
684981|NCT01952080|P3|Participant Flow|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
684982|NCT01952080|P2|Participant Flow|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
684983|NCT01952080|P1|Participant Flow|Standard of Care|SOC- no teduglutide therapy
684984|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
684985|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
684986|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
684987|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
684988|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
684989|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
684990|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
684991|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
684992|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
724311|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
685001|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
685002|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685003|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
685004|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
685005|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
685006|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685007|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
685008|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
685009|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
685010|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685011|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
685012|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
685013|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
685014|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685015|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
685016|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
685017|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
685018|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685019|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
685020|NCT01952080|O4|Outcome|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
685021|NCT01952080|O3|Outcome|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
685022|NCT01952080|O2|Outcome|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685023|NCT01952080|O1|Outcome|Standard of Care|SOC- no teduglutide therapy
685024|NCT01952080|E4|Reported Event|Teduglutide 0.05 mg/kg/Day|Cohort 3 - Teduglutide 0.05 mg/kg/day
685025|NCT01952080|E3|Reported Event|Teduglutide 0.025 mg/kg/Day|Cohort 2 - Teduglutide 0.025 mg/kg/day
685026|NCT01952080|E2|Reported Event|Teduglutide 0.0125 mg/kg/Day|Cohort 1 - Teduglutide 0.0125 mg/kg/day
685027|NCT01952080|E1|Reported Event|Standard of Care|SOC- no teduglutide therapy
685028|NCT01951950|B3|Baseline|Total|Total of all reporting groups
685029|NCT01951950|B2|Baseline|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685030|NCT01951950|B1|Baseline|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685031|NCT01951950|P2|Participant Flow|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685032|NCT01951950|P1|Participant Flow|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685033|NCT01951950|O2|Outcome|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685034|NCT01951950|O1|Outcome|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685035|NCT01951950|E2|Reported Event|Esmolol|Subjects will receive a 0.5 mg/kg bolus of esmolol as needed followed by an infusion initiated at 50 mcg/kg/min. Esmolol may be titrated every 5 minutes, increasing 50 mcg/kg/min and administering 0.5 mg/kg bolus every minute to a maximum dose of 200 mcg/kg/min. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of esmolol, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685113|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685745|NCT01947582|B1|Baseline|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
685036|NCT01951950|E1|Reported Event|Nicardipine|Subjects will receive a 15 mcg/kg bolus of nicardipine as needed followed by an infusion initiated at 5 mg/hr. Nicardipine may be titrated every 5 minutes, increasing 5 mg/hr and administering 15 mcg/kg bolus every minute to a maximum dose of 15 mg/hr. If SBP is not maintained < 140 mmHg 5 minutes after achieving the maximum dose of nicardipine, medication “failure” will be declared and rescue drug (medication to be determined per anesthesiologist discretion) will be administered. Infusions may be titrated down if SBP decreases below 90 mmHg.
685037|NCT01951820|B3|Baseline|Total|Total of all reporting groups
685038|NCT01951820|B2|Baseline|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685039|NCT01951820|B1|Baseline|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685040|NCT01951820|P2|Participant Flow|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685041|NCT01951820|P1|Participant Flow|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685042|NCT01951820|O2|Outcome|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685043|NCT01951820|O1|Outcome|Benzocaine|"Benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685044|NCT01951820|E2|Reported Event|Pliaglis|"Pliaglis topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Pliaglis: Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685045|NCT01951820|E1|Reported Event|Benzocaine|"benzocaine topical numbing gel will be applied to the gums before injection with other intervention, injection of local anesthetic articaine.~Benzocaine: Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.~Articaine: Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed"
685046|NCT01951703|B3|Baseline|Total|Total of all reporting groups
685047|NCT01951703|B2|Baseline|Test/Control|Subjects who received Test lens, senofilcon A for the first two weeks of the study and then received Control lens, senofilcon A in the last two weeks of the study.
685048|NCT01951703|B1|Baseline|Control/Test|Subjects who received Control lens, senofilcon A for the first two weeks of the study and then received Test lens, senofilcon A in the last two weeks of the study.
685049|NCT01951703|P2|Participant Flow|Test/Control|Subjects that received Test lens, senofilcon A for the first two weeks and then received Control lens senofilcon A in the last two weeks of the study.
685050|NCT01951703|P1|Participant Flow|Control/Test|Subjects that received Control lens, senofilcon A for the first two weeks and then received Test lens senofilcon A in the last two weeks of the study.
685051|NCT01951703|O2|Outcome|Test, Senofilcon A|Subjects who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
685052|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
685053|NCT01951703|O2|Outcome|Test, Senofilcon A|Subject who received Test lens, senofilcon A in either the first two weeks or the last two weeks of the study.
685054|NCT01951703|O1|Outcome|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
685055|NCT01951703|E2|Reported Event|Test, Senofilcon A|Subjects who received Test lens senofilcon A in either the first two weeks or the last two weeks of the study,
685056|NCT01951703|E1|Reported Event|Control, Senofilcon A|Subjects who received Control lens, senofilcon A in either the first two weeks or the last two weeks of the study.
685057|NCT01951651|B3|Baseline|Total|Total of all reporting groups
685058|NCT01951651|B2|Baseline|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685087|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
686621|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
685059|NCT01951651|B1|Baseline|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685060|NCT01951651|P2|Participant Flow|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685061|NCT01951651|P1|Participant Flow|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685062|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685063|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685064|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685065|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685066|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685088|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685067|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685068|NCT01951651|O2|Outcome|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685069|NCT01951651|O1|Outcome|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685070|NCT01951651|E2|Reported Event|Glipizide|"Glipizide 5 mg (tablet), one tablet twice daily orally for 6 months~Glipizide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685071|NCT01951651|E1|Reported Event|Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily for 6 months~Exenatide: Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months."
685072|NCT01951573|B1|Baseline|Overall|Delefilcon A MF and AOAMF contact lenses worn during Period 1 and Period 2 in a crossover assignment.
685073|NCT01951573|P2|Participant Flow|AOAMF, Then Delefilcon A MF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
685074|NCT01951573|P1|Participant Flow|Delefilcon A MF, Then AOAMF|Each product worn bilaterally (ie, in both eyes), as randomized, for 9-12 hours, with a 1-8 day washout separating the 2 wear periods.
685075|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685076|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685077|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685078|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685079|NCT01951573|O2|Outcome|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685080|NCT01951573|O1|Outcome|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685081|NCT01951573|E2|Reported Event|AOAMF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685082|NCT01951573|E1|Reported Event|Delefilcon A MF|Contact lenses worn during Period 1 or Period 2 for 9-12 hours
685083|NCT01951417|B1|Baseline|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685084|NCT01951417|P1|Participant Flow|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685085|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685086|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
724312|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
685089|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685090|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685091|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685092|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685093|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685094|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685095|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685096|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685097|NCT01951417|O4|Outcome|Week 8|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685098|NCT01951417|O3|Outcome|Week 4|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685099|NCT01951417|O2|Outcome|Week 2|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685100|NCT01951417|O1|Outcome|Baseline|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685101|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685102|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685103|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685104|NCT01951417|O1|Outcome|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685105|NCT01951417|E1|Reported Event|Adapalene/BPO Gel/Foam Wash/Moisturizer|"Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)~Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)~Moisturizer SPF 30: Moisturizer SPF 30 (once daily)~Foam Wash: Foam Wash (twice daily)"
685106|NCT01951170|B1|Baseline|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685107|NCT01951170|P1|Participant Flow|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 milligrams (mg) was administered subcutaneously once weekly for 24 weeks"
685108|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685109|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685110|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685111|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685112|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685523|NCT01949142|E1|Reported Event|OTO-201 Single, Intratympanic Injection|OTO-201: One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery.
685114|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685115|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685116|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685117|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685118|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685119|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685120|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685121|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685122|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685123|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685124|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685125|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685126|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685127|NCT01951170|O1|Outcome|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: 162 mg was administered subcutaneously once weekly for 24 weeks"
685128|NCT01951170|E1|Reported Event|Tocilizumab|"Participants were administered subcutaneous tocilizumab for the treatment of rheumatoid arthritis for 24 weeks.~Tocilizumab: Tocilizumab was administered 162 mg subcutaneously once weekly for 24 weeks"
685129|NCT01951092|B1|Baseline|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
685130|NCT01951092|P1|Participant Flow|Single Arm Intervention Study|"All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.~Text messaging"
685131|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
685132|NCT01951092|O1|Outcome|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
685133|NCT01951092|E1|Reported Event|Single Arm Intervention Study|All subjects receive text messages for: 1) medication reminders; 2) appointment reminders; 3) a text message addressing barriers (e.g., reminders to attend AA meetings). Each subject will undergo baseline assessments, choose personalized messages at that time. Subsequently monthly phone calls with study coordinator regarding frequency/changing messages, and then month 3 assessment, and month 6 (final assessment) with option for qualitative interview.
685134|NCT01951066|B1|Baseline|All Participants|
685135|NCT01951066|P2|Participant Flow|Group 2 (Anti-VEGF/Dexamethasone Implant)|"Patients in group 2 received prn anti-VEGF injections followed by injection of a dexamethasone implant after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
685136|NCT01951066|P1|Participant Flow|Group 1 (Dexamethasone Implant/Anti-VEGF)|"Patients in group 1 received an injection of an dexamethasone implant at baseline followed by PRN anti-VEGF injections after crossover at week 16.~Dexamethasone Implant: Patients will receive a single injection of a dexmethasone implant~Anti-VEGF injection: Patients will receive PRN injections of an anti-VEGF agent"
685137|NCT01951066|O2|Outcome|Anti-VEGF Agent|Patients received PRN injections of an Anti-VEGF agent
685138|NCT01951066|O1|Outcome|Dexamethasone Implant|Patients received an injection of an dexamethasone implant
685139|NCT01951066|E1|Reported Event|All Participants|
685743|NCT01947855|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
685140|NCT01950741|B1|Baseline|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685141|NCT01950741|P1|Participant Flow|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685142|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685143|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685144|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685145|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685146|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685147|NCT01950741|O1|Outcome|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe."
685148|NCT01950741|E1|Reported Event|Aflibercept|"Aflibercept 2 mg is injected into the vitreous cavity. Injections are given monthly three times, then are given bi-monthly to 12 months (month 0, 1, 2, 4, 6, 8, and 10; total 7 injections for 1 year).~aflibercept: Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.~Among 48 patients enrolled, one patient withdrew the consent before undergoing the first injection. Therefore the adverse event was assessed in 47 patients."
685149|NCT01950663|B1|Baseline|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
685150|NCT01950663|P1|Participant Flow|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
685151|NCT01950663|O1|Outcome|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
685152|NCT01950663|E1|Reported Event|RETeval|"RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.~RETeval: RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light."
685153|NCT01950364|B3|Baseline|Total|Total of all reporting groups
685154|NCT01950364|B2|Baseline|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685155|NCT01950364|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685156|NCT01950364|P2|Participant Flow|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 milligram (mg), capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685157|NCT01950364|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 milligram per kilogram (mg/kg), injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685158|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685159|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685160|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685161|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685543|NCT01948908|B1|Baseline|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685162|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685163|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685164|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685165|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685166|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685167|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685168|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685169|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685170|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685171|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685172|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685173|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685174|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685175|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685176|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685177|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685178|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685179|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685180|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685181|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685182|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685183|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685184|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685185|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685186|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685187|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685744|NCT01947855|E1|Reported Event|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
685188|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685189|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685190|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685191|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685192|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685193|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685194|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685195|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685196|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685197|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685198|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685199|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685200|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685201|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685202|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685203|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685204|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685205|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685206|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685207|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685208|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685209|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685210|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685211|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685212|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685213|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
686622|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
685214|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685215|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685216|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685217|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685218|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685219|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685220|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685221|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685222|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685223|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685224|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685225|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685226|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685227|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685228|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685229|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685230|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685231|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685232|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685233|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685234|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685235|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685236|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685237|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685238|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685239|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
686623|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
685240|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685241|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685242|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685243|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685244|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685245|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685246|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685247|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685248|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685249|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685250|NCT01950364|O2|Outcome|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685251|NCT01950364|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685252|NCT01950364|E2|Reported Event|Brentuximab Vedotin + Rifampicin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses and rifampicin, 600 mg, capsules, orally, once daily from Day 1 of treatment Cycle 0 through Day 21 of treatment cycle 3.
685253|NCT01950364|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg, injection, intravenously, every 3 weeks on Day 1 of each 21-day treatment cycle up to a maximum of 16 brentuximab vedotin doses.
685254|NCT01950078|B3|Baseline|Total|Total of all reporting groups
685255|NCT01950078|B2|Baseline|Healthy Volunteers Group|grouped by healthy college students
685256|NCT01950078|B1|Baseline|Surgical Patients|grouped by receiving surgery
685257|NCT01950078|P2|Participant Flow|Healthy Volunteers Group|grouped by healthy college students
685258|NCT01950078|P1|Participant Flow|Surgical Patients|grouped by receiving surgery
685259|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
685260|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
685261|NCT01950078|O2|Outcome|Healthy Volunteers Group|grouped by healthy college students
685262|NCT01950078|O1|Outcome|Surgical Patients|grouped by receiving surgery
685263|NCT01950078|E2|Reported Event|Healthy Volunteers Group|grouped by healthy college students
685264|NCT01950078|E1|Reported Event|Surgical Patients|grouped by receiving surgery
685265|NCT01949870|B1|Baseline|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
685266|NCT01949870|P1|Participant Flow|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
685267|NCT01949870|O1|Outcome|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
685268|NCT01949870|E1|Reported Event|Selumetinib+ Cisplatin + Gemcitabine|"Selumetinib (25 mg bd)~For each 21-day cycle:~Cisplatin (25 mg/m2) Days 1 and 8 Gemcitabine (1000 mg/m2) Days 1 and 8"
685269|NCT01949545|B5|Baseline|Total|Total of all reporting groups
685270|NCT01949545|B4|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685271|NCT01949545|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685544|NCT01948908|P3|Participant Flow|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685272|NCT01949545|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685273|NCT01949545|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685274|NCT01949545|P4|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685275|NCT01949545|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685276|NCT01949545|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685277|NCT01949545|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685278|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685279|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685280|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685281|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685282|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685283|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685545|NCT01948908|P2|Participant Flow|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685284|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685285|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685286|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685287|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685288|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685289|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685290|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685291|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685292|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685293|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685294|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685295|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685546|NCT01948908|P1|Participant Flow|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685296|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685297|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685298|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685299|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685300|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685301|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685302|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685303|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685304|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685305|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685306|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685307|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685547|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685308|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685309|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685310|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685311|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685312|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685313|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685314|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685315|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685316|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685317|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685318|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685319|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685548|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685320|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685321|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685322|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685323|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685324|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685325|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685326|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685327|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685328|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685329|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685330|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685331|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685549|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685332|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685333|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685334|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685335|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685336|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685337|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685338|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685339|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685340|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685341|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685342|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685343|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685550|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685344|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685345|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685346|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685347|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685348|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685349|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685350|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685351|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685352|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685353|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685354|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685355|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685551|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685356|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685357|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685358|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685359|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685360|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685361|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685362|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685363|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685364|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685365|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685366|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685367|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685552|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685368|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685369|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685370|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685371|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685372|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685373|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685374|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685375|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685376|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685377|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685378|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685379|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685553|NCT01948908|O3|Outcome|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685380|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685381|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685382|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685383|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685384|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685385|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685386|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685387|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685388|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685389|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685390|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685391|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685554|NCT01948908|O2|Outcome|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685392|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685393|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685394|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685395|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685396|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685397|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685398|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685399|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685400|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685401|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685402|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685403|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685555|NCT01948908|O1|Outcome|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685404|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685405|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685406|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685407|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685408|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685409|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685410|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685411|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685412|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685413|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685414|NCT01949545|O4|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685415|NCT01949545|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685556|NCT01948908|E3|Reported Event|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685416|NCT01949545|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685417|NCT01949545|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685418|NCT01949545|E4|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (bilirubin > 3 x ULN; any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685419|NCT01949545|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (bilirubin > 1.5-3 x ULN, any AST) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685420|NCT01949545|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (bilirubin > 1-1.5 x ULN or AST > ULN, but bilirubin ≤ ULN) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685421|NCT01949545|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (bilirubin and aspartate aminotransferase (AST) ≤ the upper limit of normal (ULN)) received carfilzomib 20 mg/m² administered by intravenous (IV) infusion on days 1 and 2 of cycle 1, followed by a planned step-up to 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² in cycle 1 received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15, and 16 of cycle 2 and subsequent 28-day cycles until confirmed progressive disease (PD), unacceptable toxicity, withdrawal of consent, study closure, or death.
685422|NCT01949532|B3|Baseline|Total|Total of all reporting groups
685423|NCT01949532|B2|Baseline|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685424|NCT01949532|B1|Baseline|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685425|NCT01949532|P2|Participant Flow|End Stage Renal Disease|Participants with end-stage renal disease (on hemodialysis) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
685426|NCT01949532|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance [CrCl] ≥ 75 mL/min) received carfilzomib 20 mg/m² intravenous infusion (IV) on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles. Participants continued treatment until confirmed progressive disease, unacceptable toxicity, withdrawal of consent, study closure, or death.
685427|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685428|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685429|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685430|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685431|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685432|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685433|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685434|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685435|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685436|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685437|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685438|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685439|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685440|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685441|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685442|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685443|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685444|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685445|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685446|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685447|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685448|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685449|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685450|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685451|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685452|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685453|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685454|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685455|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685456|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685457|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685458|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685459|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685460|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685461|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685462|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685463|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685464|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685465|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685466|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685467|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685468|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685469|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685470|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685471|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685472|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685473|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685474|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685475|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685476|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685477|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685478|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685479|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685480|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685481|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685482|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685483|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685484|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685485|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685486|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685487|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685488|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685489|NCT01949532|O2|Outcome|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685490|NCT01949532|O1|Outcome|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685491|NCT01949532|E2|Reported Event|End Stage Renal Disease|Participants with ESRD received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685492|NCT01949532|E1|Reported Event|Normal Renal Function|Participants with normal renal function received carfilzomib 20 mg/m² IV on days 1 and 2 of cycle 1, followed by 27 mg/m² IV on days 8, 9, 15, and 16 of cycle 1. Participants who adequately tolerated dosing at 27 mg/m² received carfilzomib 56 mg/m² IV on days 1, 2, 8, 9, 15 and 16 of cycle 2 and all subsequent cycles.
685493|NCT01949389|B1|Baseline|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
685494|NCT01949389|P1|Participant Flow|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
685495|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
685496|NCT01949389|O1|Outcome|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
685497|NCT01949389|E1|Reported Event|Internet-based Cognitive Behavioral Therapy for Insomnia|"This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.~Internet-based Cognitive Behavioral Therapy for Insomnia: This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered."
685498|NCT01949155|B3|Baseline|Total|Total of all reporting groups
685499|NCT01949155|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685500|NCT01949155|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685501|NCT01949155|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685502|NCT01949155|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685503|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery"
685504|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685505|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery"
685506|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685507|NCT01949155|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685508|NCT01949155|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685509|NCT01949155|E2|Reported Event|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685510|NCT01949155|E1|Reported Event|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685511|NCT01949142|B3|Baseline|Total|Total of all reporting groups
685512|NCT01949142|B2|Baseline|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685513|NCT01949142|B1|Baseline|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685514|NCT01949142|P2|Participant Flow|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685515|NCT01949142|P1|Participant Flow|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685516|NCT01949142|O2|Outcome|Sham|Sham: Simulated single, intratympanic injection: One sham injection into each ear during surgery.
685517|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685518|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685519|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685520|NCT01949142|O2|Outcome|Sham|"Sham: Simulated single, intratympanic injection:~One sham injection into each ear during surgery."
685521|NCT01949142|O1|Outcome|OTO-201|"OTO-201: Single, intratympanic injection:~One injection of 6 mg OTO-201 (ciprofloxacin in poloxamer 407) into each ear during surgery."
685522|NCT01949142|E2|Reported Event|Sham-Simulated Single, Intratympanic Injection|Sham: One sham injection into each ear during surgery.
724313|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
685524|NCT01949051|B1|Baseline|Placebo/Levocabastine|Participants received placebo/ Levo at a dose of 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) into each nostril or 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days each, in a crossover design. Treatment was given in one of six sequences in Periods 1, 2, and 3, (14 to 20 day washout period between treatments): ABC, BCA, CAB, ACB, BAC, CBA (A, Levo 200µg; B, Levo 400µg: C, Placebo). On Day 8 of each treatment period (approximately 12 hours post dosing for treatment A and 24 hours post dosing for treatment B and C), participants entered the environmental exposure chamber (EEC) for a 4-hour period, and the assessments were conducted 12-24 hours post-dose. All participants attended a follow-up visit within 7 to 14 day after their final dose, and the overall duration for participation in the study (screening to follow-up) was 13 weeks.
685525|NCT01949051|P6|Participant Flow|Sequence 6: Placebo, Levo 400µg and Levo 200µg|Participants received placebo, Levo 400µg and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
685526|NCT01949051|P5|Participant Flow|Sequence 5: Levo 400µg, Levo 200µg and Placebo|Participants received Levo 400µg, Levo 200µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
685527|NCT01949051|P4|Participant Flow|Sequence 4: Levo 200µg, Placebo, and Levo 400µg|Participants received Levo 200µg, placebo, and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
685528|NCT01949051|P3|Participant Flow|Sequence 3: Placebo, Levo 200µg and Levo 400µg|Participants received placebo, Levo 200µg and Levo 400µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
685529|NCT01949051|P2|Participant Flow|Sequence 2: Levo 400µg, Placebo and Levo 200µg|Participants received Levo 400µg, placebo and Levo 200µg in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg OD in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg BID in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
685530|NCT01949051|P1|Participant Flow|Sequence 1: Levo 200 µg, Levo 400µg, Placebo|Participants received levocabastine (Levo) 200 micrograms (µg), Levo 400µg and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received the Levo 200 µg once daily (OD) in the morning as 2 nasal sprays (50 µg per spray) and placebo in the evening into each nostril or placebo/ Levo 400 µg twice daily (BID) in the morning and evening as 2 nasal sprays (50 µg per spray) into each nostril for 7 days. The three treatment periods were separated by a washout period of 14 to 20 days.
685531|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685532|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685533|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685534|NCT01949051|O3|Outcome|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685535|NCT01949051|O2|Outcome|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685536|NCT01949051|O1|Outcome|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685537|NCT01949051|E3|Reported Event|Levocabastine 400µg BID|Participants received levocabastine 400 µg BID as two 50 µg nasal sprays into each nostril in the morning and evening for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685538|NCT01949051|E2|Reported Event|Levocabastine 200µg OD|Participants received levocabastine 200 µg once daily OD as two 50 µg nasal sprays into each nostril in the morning for 7 days during one of the three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685539|NCT01949051|E1|Reported Event|Placebo|Participants received placebo BID as 2 nasal sprays per nostril in the morning and evening for 7 days during one of three treatment periods. Each treatment period was followed by a washout period of 14 to 20 days.
685540|NCT01948908|B4|Baseline|Total|Total of all reporting groups
685541|NCT01948908|B3|Baseline|1000 mcL VOA|"Intranasal midazolam administered in 1000 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685542|NCT01948908|B2|Baseline|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685652|NCT01948076|O1|Outcome|Resident Without GE Vscan|baseline physical exam use
685557|NCT01948908|E2|Reported Event|500 mcL VOA|"Intranasal midazolam administered in 500 mcL VOA.~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685558|NCT01948908|E1|Reported Event|200 mcL VOA|"Intranasal midazolam administered in 200 mcL VOA~Intranasal midazolam: Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD)."
685559|NCT01948830|B3|Baseline|Total|Total of all reporting groups
685560|NCT01948830|B2|Baseline|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685561|NCT01948830|B1|Baseline|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685562|NCT01948830|P2|Participant Flow|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685563|NCT01948830|P1|Participant Flow|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685564|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685565|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685566|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685567|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685568|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685569|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685570|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685571|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685572|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685573|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685574|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685575|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685576|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685577|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685578|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685579|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685580|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685581|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685582|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685583|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685584|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685585|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685586|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685587|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685588|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685589|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685590|NCT01948830|O2|Outcome|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685591|NCT01948830|O1|Outcome|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685592|NCT01948830|E2|Reported Event|Group II Ranibizumab 0.5 mg Monthly|Ranibizumab 0.5 mg/0.05 mL (Monthly regimen)
685593|NCT01948830|E1|Reported Event|Group I Ranibizumab 0.5 mg TER|Ranibizumab 0.5 mg/0.05 mL (TER) treat and Extend regimen
685594|NCT01948791|B1|Baseline|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685595|NCT01948791|P1|Participant Flow|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685596|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685597|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685598|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685599|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685600|NCT01948791|O1|Outcome|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685601|NCT01948791|E1|Reported Event|ENA713|Patients had a dose escalation from 3mg/d to 12mg/d to reach individual tolerated dosage during the titration period of 12 weeks.
685602|NCT01948518|B1|Baseline|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
685603|NCT01948518|P1|Participant Flow|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
685604|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
685605|NCT01948518|O1|Outcome|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
685606|NCT01948518|E1|Reported Event|Sildenafil|"20 mg of oral sildenafil, single dose at baseline~Oral sildenafil 20 mg: A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug."
685607|NCT01948375|B3|Baseline|Total|Total of all reporting groups
685608|NCT01948375|B2|Baseline|Real Needle - Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685609|NCT01948375|B1|Baseline|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685610|NCT01948375|P2|Participant Flow|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
685611|NCT01948375|P1|Participant Flow|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
685612|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685613|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685614|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685653|NCT01948076|E2|Reported Event|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
685654|NCT01948076|E1|Reported Event|Resident Without GE Vscan|baseline physical exam use
685655|NCT01948063|B3|Baseline|Total|Total of all reporting groups
685657|NCT01948063|B1|Baseline|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
685615|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685616|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~real needle- placebo needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685617|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~placebo needle - real needle: All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685618|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685619|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685620|NCT01948375|O2|Outcome|Real Needle- Placebo Needle|"Participants received acupuncture with real needle in the first period, and with pragmatic placebo acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685621|NCT01948375|O1|Outcome|Placebo Needle - Real Needle|"Participants received acupuncture with pragmatic placebo needle in the first period, and with real acupuncture needle in the second period.~All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles."
685622|NCT01948375|E2|Reported Event|Placebo Needle - Real Needle|"Participants will accept acupuncture with pragmatic placebo needle in the first period, and real acupuncture needle in the second period of the trial.~placebo needle - real needle: Participants will accept acupuncture with pragmatic placebo needle in the first period, and real needle in the second period. Acupoints will be needled with no penetration of the skin by placebo needle, while 1 cun by real acupuncture needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
685656|NCT01948063|B2|Baseline|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
685742|NCT01947855|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
685623|NCT01948375|E1|Reported Event|Real Needle- Placebo Needle|"Participants will accept acupuncture with real acupuncture needle in the first period, and pragmatic placebo needle in the second period of the trial.~real needle- placebo needle: Participants will accept acupuncture with real needle in the first period and pragmatic placebo needle in the second period. Acupoints are to be needled 1 cun by real needle in the first period, and pressed against the skin with no penetration by placebo needle in the second period. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants will be asked questions on skin penetration of needles, needling pain and needle sensation. The acupuncture treatment is given every other day. There are three sessions for each kind of needle, six sessions in total for each participant. There is a two-day interval between two kinds of interventions."
685624|NCT01948193|B1|Baseline|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685625|NCT01948193|P1|Participant Flow|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685626|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685627|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685628|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685629|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685630|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685631|NCT01948193|O1|Outcome|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP-IPV-HB-PRP-T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685632|NCT01948193|E1|Reported Event|All Infants|Infants aged 6 to 8 weeks received 3 injections of Sanofi Pasteur’s DTaP IPV HB PRP T combined vaccine at 6, 10 and 14 weeks of age following a documented dose of a commercial oral poliovirus vaccine and recombinant Hepatitis B monovalent vaccine at birth.
685633|NCT01948141|B1|Baseline|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
685634|NCT01948141|P1|Participant Flow|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
685635|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685636|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685637|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685638|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685639|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685640|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685641|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685642|NCT01948141|O1|Outcome|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO"
685643|NCT01948141|E1|Reported Event|Treatment (Nintedanib)|"Patients receive nintedanib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~nintedanib: Given PO~laboratory biomarker analysis: Correlative studies"
685644|NCT01948076|B3|Baseline|Total|Total of all reporting groups
685645|NCT01948076|B2|Baseline|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
685646|NCT01948076|B1|Baseline|Resident Without GE Vscan|baseline physical exam use
685647|NCT01948076|P2|Participant Flow|Intervention Group|Received training and access to ultrasounds. During assessment performed physical exam first followed by ultrasound exam
685648|NCT01948076|P1|Participant Flow|Control Group|Performed only physical exam with no access to ultrasoun
685649|NCT01948076|O2|Outcome|Intervention Group (Using Ultrasound)|residents with augmentation of physical exam by ultrasound
685650|NCT01948076|O1|Outcome|Intervention Group (Using Physical Exam Only)|Baseline physical exam prior to using the ultrasound
685651|NCT01948076|O2|Outcome|Resident With GE Vscan|residents with augmentation of physical exam by ultrasound
685658|NCT01948063|P2|Participant Flow|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
685659|NCT01948063|P1|Participant Flow|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
685660|NCT01948063|O2|Outcome|Ubiquinol|Patients will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
685661|NCT01948063|O1|Outcome|Placebo|Patients will receive a placebo pill or a liquid placebo. The liquid placebo is 50 milliliters of Ensure (a dietary supplement). Placebo will be given every 12 hours for 7 days or until hospital discharge.
685662|NCT01948063|E2|Reported Event|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
685663|NCT01948063|E1|Reported Event|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg of Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
685664|NCT01948050|B3|Baseline|Total|Total of all reporting groups
685665|NCT01948050|B2|Baseline|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
685666|NCT01948050|B1|Baseline|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
685667|NCT01948050|P2|Participant Flow|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
685668|NCT01948050|P1|Participant Flow|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
685669|NCT01948050|O2|Outcome|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
685670|NCT01948050|O1|Outcome|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
685671|NCT01948050|E2|Reported Event|Sham tDCS|sham non-invasive transcranial direct current stimulation (tDCS) consisting of 30 seconds of tDCS stimulation at 2mp and 19 minutes and 30 seconds of tdcs at 0mp stimulation,on five consecutive days.
685672|NCT01948050|E1|Reported Event|Real tDCS Stimulation|non-invasive transcranial direct current stimulation (tDCS) at 2 milliamiampers (2mA)for 20 minutes at each session, on five consecutive days.
685673|NCT01947946|B4|Baseline|Total|Total of all reporting groups
685674|NCT01947946|B3|Baseline|Placebo|A (Dummy) injection
685675|NCT01947946|B2|Baseline|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
685676|NCT01947946|B1|Baseline|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
685677|NCT01947946|P3|Participant Flow|Placebo|A (Dummy) injection
685678|NCT01947946|P2|Participant Flow|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
685679|NCT01947946|P1|Participant Flow|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
685680|NCT01947946|O3|Outcome|Placebo|A (Dummy) injection
685681|NCT01947946|O2|Outcome|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
685682|NCT01947946|O1|Outcome|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
685683|NCT01947946|E3|Reported Event|Placebo|A (Dummy) injection
685684|NCT01947946|E2|Reported Event|Benra 30 Mg-Placebo q.8 Weeks|Fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administered at the 4 week interim treatment visits to maintain blind).
685685|NCT01947946|E1|Reported Event|Benra 30 mg q.4 Weeks|Fixed 30 mg dose of benralizumab every 4 weeks.
685686|NCT01947907|B5|Baseline|Total|Total of all reporting groups
685687|NCT01947907|B4|Baseline|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685688|NCT01947907|B3|Baseline|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685689|NCT01947907|B2|Baseline|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685690|NCT01947907|B1|Baseline|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685691|NCT01947907|P4|Participant Flow|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685692|NCT01947907|P3|Participant Flow|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685693|NCT01947907|P2|Participant Flow|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685694|NCT01947907|P1|Participant Flow|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
724314|NCT01717989|O4|Outcome|Q3 2011|Third quarter, 2011
685695|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685696|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685697|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685698|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685699|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685700|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685701|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685702|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685703|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685704|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685705|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685706|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685707|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685708|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685709|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685710|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685711|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685712|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685713|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685714|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685715|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685716|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685717|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685718|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685719|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685720|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685721|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685722|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685723|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685724|NCT01947907|O4|Outcome|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685725|NCT01947907|O3|Outcome|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685726|NCT01947907|O2|Outcome|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685727|NCT01947907|O1|Outcome|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685728|NCT01947907|E4|Reported Event|Human Growth Hormone|"Once daily subcutaneous injection of human Growth Hormone (rhGH)~Human Growth Hormone: Once daily subcutaneous injection of human Growth Hormone"
685729|NCT01947907|E3|Reported Event|ACP-001, Dose-level 3|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685730|NCT01947907|E2|Reported Event|ACP-001, Dose-level 2|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685731|NCT01947907|E1|Reported Event|ACP-001, Dose-level 1|"Once weekly subcutaneous injection of ACP-001~ACP-001: Once weekly subcutaneous injection"
685732|NCT01947855|B4|Baseline|Total|Total of all reporting groups
685733|NCT01947855|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
685734|NCT01947855|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
685735|NCT01947855|B1|Baseline|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
685736|NCT01947855|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
685737|NCT01947855|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
685738|NCT01947855|P1|Participant Flow|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
685739|NCT01947855|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25mg oral administration once daily
685740|NCT01947855|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg oral administration once daily
685741|NCT01947855|O1|Outcome|Placebo|Placebo tablets matching empagliflozin 10 mg or 25 mg tablets
685746|NCT01947582|P1|Participant Flow|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
685747|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
685748|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
685749|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
685750|NCT01947582|O1|Outcome|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
685751|NCT01947582|E1|Reported Event|Application of Ankle Foot Orthosis|persons in this group were fitted with bilateral ankle foot orthoses
685752|NCT01947517|B3|Baseline|Total|Total of all reporting groups
685753|NCT01947517|B2|Baseline|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685754|NCT01947517|B1|Baseline|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685755|NCT01947517|P2|Participant Flow|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685756|NCT01947517|P1|Participant Flow|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685757|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685758|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685759|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685760|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685761|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685762|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685763|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685764|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685765|NCT01947517|O2|Outcome|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685766|NCT01947517|O1|Outcome|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685767|NCT01947517|E2|Reported Event|Superflex Group|"Randomized to receive Group B punctal plugs~Superflex Punctal Occluder"
685768|NCT01947517|E1|Reported Event|Parasol Group|"Randomized to receive Brand A punctal plugs~Parasol Punctal Occluder"
685769|NCT01947491|B5|Baseline|Total|Total of all reporting groups
685770|NCT01947491|B4|Baseline|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
685771|NCT01947491|B3|Baseline|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
685772|NCT01947491|B2|Baseline|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
685773|NCT01947491|B1|Baseline|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
685774|NCT01947491|P4|Participant Flow|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
685775|NCT01947491|P3|Participant Flow|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
685776|NCT01947491|P2|Participant Flow|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
685777|NCT01947491|P1|Participant Flow|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
685778|NCT01947491|O4|Outcome|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
685779|NCT01947491|O3|Outcome|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
685780|NCT01947491|O2|Outcome|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
685781|NCT01947491|O1|Outcome|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
685782|NCT01947491|E4|Reported Event|Vehicle Lotion|"Vehicle Lotion twice daily for 28 days~Vehicle Lotion"
685783|NCT01947491|E3|Reported Event|Comp01 Lotion|"Comp01 Lotion twice daily for 14 days~Comp01 Lotion"
685784|NCT01947491|E2|Reported Event|Vehicle Spray|"Vehicle Spray twice daily for 28 days~Vehicle Spray"
685785|NCT01947491|E1|Reported Event|DFD01 Spray|"DFD01 Spray twice daily for 28 days~DFD01 Spray"
685786|NCT01947335|B3|Baseline|Total|Total of all reporting groups
685787|NCT01947335|B2|Baseline|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
685788|NCT01947335|B1|Baseline|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
685789|NCT01947335|P2|Participant Flow|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
685790|NCT01947335|P1|Participant Flow|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
685791|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
685792|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
685793|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
685794|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
685795|NCT01947335|O2|Outcome|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
685796|NCT01947335|O1|Outcome|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
685797|NCT01947335|E2|Reported Event|IVUS-guided PCI|"Intravascular ultrasound guided percutaneous coronary intervention~IVUS-guided PCI: Intravascular ultrasound guided percutaneous coronary intervention"
685798|NCT01947335|E1|Reported Event|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention
686624|NCT01941498|O2|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
685799|NCT01947153|B1|Baseline|All Subjects|All subjects treated with 5 mg linagliptin / 1000 mg metformin as fixed dose combination or as free dose combination.
685800|NCT01947153|P2|Participant Flow|Free Combination First, Then Fixed Dose Combination|Free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet first; then 5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets
685801|NCT01947153|P1|Participant Flow|Fixed Dose Combination First, Then Free Combination|5 mg linagliptin / 1000mg metformin given as two 2.5mg linagliptin / 500mg metformin fixed dose combination (FDC) tablets first; then free combination: one 5mg linagliptin tablet and one 1000mg metformin tablet
685802|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685803|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685804|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685805|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685806|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685807|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685808|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685809|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685810|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685811|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685812|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685813|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685814|NCT01947153|O2|Outcome|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685815|NCT01947153|O1|Outcome|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685816|NCT01947153|E2|Reported Event|Free Combination|"Linagliptin and Metformin~Metformin: Free combination 5mg Linagliptin: Free combination 1000mg"
685817|NCT01947153|E1|Reported Event|Fixed Dose Combination|"Linagliptin/Metformin~Linagliptin: Fixed dose combination: 2x 2.5mg Metformin: Combination: 500mg"
685818|NCT01947127|B3|Baseline|Total|Total of all reporting groups
685819|NCT01947127|B2|Baseline|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
685820|NCT01947127|B1|Baseline|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
685821|NCT01947127|P2|Participant Flow|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
685822|NCT01947127|P1|Participant Flow|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
685823|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
685824|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
685825|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
685826|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
685827|NCT01947127|O2|Outcome|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
685828|NCT01947127|O1|Outcome|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
685829|NCT01947127|E2|Reported Event|Low Lactate|Initial venous lactate level less than 2.0 mmol/L
685830|NCT01947127|E1|Reported Event|High Lactate|Initial venous lactate level equal to or more than 2.0 mmol/L
685831|NCT01946542|B3|Baseline|Total|Total of all reporting groups
685832|NCT01946542|B2|Baseline|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
685833|NCT01946542|B1|Baseline|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
685834|NCT01946542|P2|Participant Flow|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
685835|NCT01946542|P1|Participant Flow|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
685836|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
685837|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
685838|NCT01946542|O2|Outcome|Beet Juice Concentrate First, Then Placebo|"Testing visit 1: Participants are given a single dose of beet juice concentrate, roughly 70 mL.~Testing Visit 2: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink."
685867|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
686012|NCT01945970|E2|Reported Event|Positive Control|Spray dried aqueous extract of a batch of tea extract that has shown to improve Flow Mediated Dilation previously
685839|NCT01946542|O1|Outcome|Placebo First Then Beet Juice Concentrate|"Testing visit 1: Participants are given a placebo drink, single dose. The placebo drink is taste and color-matched to the experimental drink.~Testing visit 2: Participants are given a single dose of beet juice concentrate, roughly 70 mL."
685840|NCT01946542|E2|Reported Event|Beet Juice Concentrate|
685841|NCT01946542|E1|Reported Event|Placebo|
685842|NCT01946529|B4|Baseline|Total|Total of all reporting groups
685843|NCT01946529|B3|Baseline|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
685844|NCT01946529|B2|Baseline|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
685845|NCT01946529|B1|Baseline|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
685846|NCT01946529|P3|Participant Flow|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
685847|NCT01946529|P2|Participant Flow|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
685848|NCT01946529|P1|Participant Flow|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
685849|NCT01946529|O1|Outcome|Group B (High Risk) - ESFT|Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation.
685850|NCT01946529|E4|Reported Event|Group B (High Risk) - Total|"All Group B High Risk participants with ESFT or DSRCT.~Participants received vincristine, doxorubicin, cyclophosphamide, ifosfamide, and etoposide. Patients with measurable disease were eligible to receive irinotecan, temozolomide, and temsirolimus. Additionally, all patients were eligible to receive a maintenance therapy at the end of treatment including bevacizumab and sorafenib. Depending on the size and location of the participant's tumor, they had surgery alone, radiation alone, or surgery followed by radiation."
685851|NCT01946529|E3|Reported Event|Group B (High Risk) - DSRCT|Group B participants with a diagnosis of Desmoplastic Small Round Cell Tumor (DSRCT).
685852|NCT01946529|E2|Reported Event|Group B (High Risk) - ESFT|Group B participants with a diagnosis of Ewing Sarcoma Family of Tumor (ESFT).
685853|NCT01946529|E1|Reported Event|Group A (Standard Risk)|Participants will receive vincristine, doxorubicin, cyclophosphamide, ifosfamide and etoposide. Doxorubicin will be omitted following a total cumulative dose of 375 mg/m^2. Depending on the size and location of the participant's tumor, they will have surgery alone, radiation alone, or surgery followed by radiation. Local control measures (surgery and/or radiation therapy) will be instituted after 6 courses of chemotherapy. Total duration of treatment is approximately 29 weeks.
685854|NCT01946438|B5|Baseline|Total|Total of all reporting groups
685855|NCT01946438|B4|Baseline|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685856|NCT01946438|B3|Baseline|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685857|NCT01946438|B2|Baseline|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685858|NCT01946438|B1|Baseline|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685859|NCT01946438|P4|Participant Flow|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685860|NCT01946438|P3|Participant Flow|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685861|NCT01946438|P2|Participant Flow|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685862|NCT01946438|P1|Participant Flow|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685863|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685864|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685865|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a 0.1 mL dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685866|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685902|NCT01946425|E2|Reported Event|Age 3 Years to <9 Years Group|Participants age 3 years to < 9 years of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
685868|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685869|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685870|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685871|NCT01946438|O4|Outcome|Elderly Fluzone® High Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685872|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685873|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685874|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685875|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685876|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685877|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685878|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Vaccine 2013-2014 formulation
685879|NCT01946438|O4|Outcome|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685880|NCT01946438|O3|Outcome|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685881|NCT01946438|O2|Outcome|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685882|NCT01946438|O1|Outcome|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685883|NCT01946438|E4|Reported Event|Elderly Fluzone® High-Dose, Influenza Vaccine (Group 4)|Participants age ≥ 65 years who received a dose of Fluzone® High-Dose, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685884|NCT01946438|E3|Reported Event|Elderly Fluzone® Quadrivalent, Influenza Vaccine (Group 3)|Participants age ≥ 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685885|NCT01946438|E2|Reported Event|Adult Fluzone® Intradermal, Influenza Vaccine (Group 2)|Participants age 18 to < 65 years who received a dose of Fluzone® Intradermal, Influenza Virus Vaccine intradermally (2013-2014 formulation)
685886|NCT01946438|E1|Reported Event|Adult Fluzone® Quadrivalent, Influenza Vaccine (Group 1)|Participants age 18 to < 65 years who received a dose of Fluzone® Quadrivalent, Influenza Virus Vaccine intramuscularly (2013-2014 formulation)
685887|NCT01946425|B3|Baseline|Total|Total of all reporting groups
685888|NCT01946425|B2|Baseline|Age 3 to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
685889|NCT01946425|B1|Baseline|Age 6 to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent Influenza Virus Vaccine (2013-2014 formulation)
685890|NCT01946425|P2|Participant Flow|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age who received a 0.5 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
685891|NCT01946425|P1|Participant Flow|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age who received a 0.25 mL dose of Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
685892|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation)
685893|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685894|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685895|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685896|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685897|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685898|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685899|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685900|NCT01946425|O2|Outcome|Age 3 Years to <9 Years Group|Participants 3 years to <9 years of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685901|NCT01946425|O1|Outcome|Age 6 Months to <36 Months Group|Participants 6 months to <36 months of age that received Fluzone® Quadrivalent, Influenza Vaccine (2013-2014 formulation)
685903|NCT01946425|E1|Reported Event|Age 6 Months to <36 Months Group|Participants 6 months to < 36 months of age that received Fluzone® Quadrivalent Influenza Vaccine (2013-2014 formulation)
685904|NCT01946412|B1|Baseline|Ivacaftor|Participants received ivacaftor 50 mg or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered q12h for participants aged 2 to < 6 years and weighing <14 kg, ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing >= 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
685905|NCT01946412|P1|Participant Flow|Ivacaftor|Participants received ivacaftor 50 milligram (mg) or 75 mg or 150 mg based on body weight and age. Ivacaftor 50 mg administered every 12 hours (q12h) for participants aged 2 to less than (<) 6 years and weighing <14 kilograms (kg), ivacaftor 75 mg q12h for participants aged 2 to <6 years and weighing greater than or equal to (>=) 14 kg and ivacaftor 150 mg q12h for participants >=6 years.
685906|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685907|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685908|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685909|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685910|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685911|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685912|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685913|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685914|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685915|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685916|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685917|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685918|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685919|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685920|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685921|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685922|NCT01946412|O2|Outcome|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685923|NCT01946412|O1|Outcome|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685924|NCT01946412|E2|Reported Event|Ivacaftor 75 mg|Participants who received ivacaftor 75 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685925|NCT01946412|E1|Reported Event|Ivacaftor 50 mg|Participants who received ivacaftor 50 mg q12h in parent study VX11-770-108 (NCT01705145), received either ivacaftor 50 mg q12h for participants aged 2 to <6 years and weighing <14 kg or ivacaftor 75 mg q12h for participants aged 2 to <6 years and >=14 kg or ivacaftor 150 mg q12h for participants >=6 years in this study (NCT01946412).
685926|NCT01946243|B1|Baseline|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
685927|NCT01946243|P1|Participant Flow|Florbetapir PET Scans|No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A07[NCT00857415]/A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A07/A16) and 50 randomly selected non-autopsy scans (A17).
685928|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
685929|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
685930|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
685931|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
685932|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
685933|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
685934|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
685935|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
685936|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
685937|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
685938|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
685939|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
685940|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
685941|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
685942|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
685943|NCT01946243|O3|Outcome|Change|Change = VisQ - Qualitative
685944|NCT01946243|O2|Outcome|VisQ|Quantitation as an adjunct to qualitative scan interpretation
685945|NCT01946243|O1|Outcome|Qualitative|Qualitative scan interpretation only
685946|NCT01946243|E1|Reported Event|Florbetapir PET Scans|No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A07/A16 and A17).
685947|NCT01946178|B1|Baseline|All Treated Patients|All patients who underwent treatment with the device
685948|NCT01946178|P1|Participant Flow|All Treated Patients|All patients who underwent treatment with the device
685949|NCT01946178|O2|Outcome|Entire Validation Cohort|The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 36 patients in the Validation Cohort.
685950|NCT01946178|O1|Outcome|Entire Development Cohort|The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for all 37 patients in the Development Cohort.
685951|NCT01946178|O2|Outcome|Validation Cohort With NPVs Observed|"The Validation Cohort includes the last 36 patients treated in the study sequence. Treatments in the Validation Cohort were used to refine and validate the final HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 35 out of 36 patients (97.2%) in the Validation Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
685952|NCT01946178|O1|Outcome|Development Cohort With NPVs Observed|"The Development Cohort includes the first 37 patients treated in the study sequence. Treatments in the Development Cohort were used for dose-ranging purposes to develop the most appropriate HIFU parameters for uterine fibroid treatment with the device. Outcomes are reported for the 33 out of 37 patients (89.2%) in the Development Cohort with NPVs observed following treatment.~Overall, 68 out of 73 patients (93.2%) in the entire study had NPVs observed following treatment."
685953|NCT01946178|O1|Outcome|All Treated Patients|All patients who underwent treatment with the device
685954|NCT01946178|E1|Reported Event|All Treated Patients|All patients who underwent treatment with the device
685955|NCT01946126|B3|Baseline|Total|Total of all reporting groups
685956|NCT01946126|B2|Baseline|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685957|NCT01946126|B1|Baseline|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685958|NCT01946126|P2|Participant Flow|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685959|NCT01946126|P1|Participant Flow|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685960|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685961|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685962|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685963|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685964|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685965|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685966|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685967|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685968|NCT01946126|O2|Outcome|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685969|NCT01946126|O1|Outcome|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685970|NCT01946126|E2|Reported Event|Other Headache Diagnoses|This is a retrospective chart review of patients with headache diagnoses other than Chronic Migraine. There is no intervention in this study.
685971|NCT01946126|E1|Reported Event|Chronic Migraine Diagnosis|This is a retrospective chart review for patients diagnosed with Chronic Migraine. There is no intervention in this study.
685972|NCT01945970|B1|Baseline|Study Subjects|All six treatment orders combined
685973|NCT01945970|P6|Participant Flow|Placebo - Black Tea - Positive Control|"Subjects treated in the order Placebo - wash out - Black tea - wash out- Positive control.~Treatments each lasted one week and were separated by a one week washout."
685974|NCT01945970|P5|Participant Flow|Placebo- Positive Control - Black Tea|"Subjects treated in the order Placebo - wash out - Positive control - wash out- Black tea.~Treatments each lasted one week and were separated by a one week washout."
685975|NCT01945970|P4|Participant Flow|Positive Control - Placebo - Black Tea|"Subjects treated in the order Positive control - wash out - Placebo - wash out - Black tea.~Treatments each lasted one week and were separated by a one week washout."
685976|NCT01945970|P3|Participant Flow|Positive Control - Black Tea - Placebo|"Subjects treated in the order Positive control - wash out - Black tea - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
685977|NCT01945970|P2|Participant Flow|Black Tea - Placebo - Positive Control|"Subjects treated in the order Black tea - wash out- Placebo control - wash out - Positive control.~Treatments each lasted one week and were separated by a one week washout."
685978|NCT01945970|P1|Participant Flow|Black Tea - Positive Control - Placebo|"Subjects treated in the order Black tea - wash out- Positive control - wash out - Placebo.~Treatments each lasted one week and were separated by a one week washout."
685979|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685980|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
685981|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685982|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
685983|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685984|NCT01945970|O1|Outcome|Postive Control Beverage|Participant when they received the positive control
685985|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685986|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
685987|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685988|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
685989|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685990|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
685991|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685992|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
685993|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685994|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
685995|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685996|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
685997|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
685998|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
685999|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
686000|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
686001|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
686002|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
686003|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
686004|NCT01945970|O1|Outcome|Positive Control Beverage|Participant when they received the positive control
686005|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
686006|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back tea
686007|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
686008|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
686009|NCT01945970|O2|Outcome|Placebo Beverage|Participants when the received Placebo
686010|NCT01945970|O1|Outcome|Black Tea Beverage|Participant when they received Back Tea
686011|NCT01945970|E3|Reported Event|Placebo|Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract
686013|NCT01945970|E1|Reported Event|Black Tea Extract|Spray dried aqueous extract of a representative batch of black tea
686014|NCT01945944|B3|Baseline|Total|Total of all reporting groups
686015|NCT01945944|B2|Baseline|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
686016|NCT01945944|B1|Baseline|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
686017|NCT01945944|P2|Participant Flow|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
686018|NCT01945944|P1|Participant Flow|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
686019|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686020|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686021|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686022|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686023|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686024|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686025|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686026|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686027|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686028|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686029|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686030|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686031|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686032|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686033|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%): 3mL of HTS given via nebulizer every 6hrs"
686034|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline): 3mL of normal saline given via nebulizer every 6hrs"
686035|NCT01945944|O2|Outcome|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
686036|NCT01945944|O1|Outcome|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
686037|NCT01945944|E2|Reported Event|Hypertonic Saline|"Hypertonic saline (3%), 3mL every 6hrs for up to 7 days~Hypertonic saline (3%)"
686038|NCT01945944|E1|Reported Event|Placebo|"Placebo (0.9% saline), 3mL every 6 hrs for up to 7 days~Placebo (0.9% saline)"
686039|NCT01945294|B4|Baseline|Total|Total of all reporting groups
686040|NCT01945294|B3|Baseline|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
686041|NCT01945294|B2|Baseline|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686042|NCT01945294|B1|Baseline|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686043|NCT01945294|P4|Participant Flow|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
686044|NCT01945294|P3|Participant Flow|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686045|NCT01945294|P2|Participant Flow|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686046|NCT01945294|P1|Participant Flow|All Treated Participants|All screened and enrolled participants initially underwent a 12-week (4 weeks PR + 8 weeks BOC + PR) lead-in treatment period prior to randomization to Arms 1 or 2 (participants with undetectable hepatitis C virus [HCV] ribonucleic acid [RNA]) or allocation to Arm 3 (participants with detectable HCV RNA).
686047|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
686156|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686048|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686049|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686050|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
686051|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686052|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686053|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
686054|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686055|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686056|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
686057|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686058|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686059|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
686060|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686061|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686062|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
686063|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686064|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686065|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
686066|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686067|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686117|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686625|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
686068|NCT01945294|O3|Outcome|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60).
686069|NCT01945294|O2|Outcome|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686070|NCT01945294|O1|Outcome|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686071|NCT01945294|E3|Reported Event|Arm 3: 48-week Treatment Arm|After completing the 12-week lead-in, participants with detectable HCV RNA were allocated to receive an additional 24 weeks of BOC + PR and an additional 12 weeks of PR, for a total of 48 weeks of treatment. At Week 48, participants underwent 12 weeks of follow-up (participation complete at Week 60). In addition, 21 participants who were treated but discontinued prior to Week 12 are included in Arm 3 for safety analyses.
686072|NCT01945294|E2|Reported Event|Arm 2: 28-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 16 weeks of BOC + PR, for a total of 28 weeks of treatment. At Week 28, participants underwent 12 weeks of follow-up (participation complete at Week 40).
686073|NCT01945294|E1|Reported Event|Arm 1: 16-week Treatment Arm|After completing the 12-week lead-in, participants with undetectable HCV RNA were randomized to receive an additional 4 weeks of BOC + PR, for a total of 16 weeks of treatment. At Week 16, participants underwent 12 weeks of follow-up (participation complete at Week 28).
686074|NCT01945242|B3|Baseline|Total|Total of all reporting groups
686075|NCT01945242|B2|Baseline|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
686076|NCT01945242|B1|Baseline|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
686077|NCT01945242|P2|Participant Flow|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
686078|NCT01945242|P1|Participant Flow|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
686079|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
686080|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
686081|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
686082|NCT01945242|O1|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months.
686083|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
686084|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
686085|NCT01945242|O2|Outcome|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
686086|NCT01945242|O1|Outcome|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
686087|NCT01945242|E2|Reported Event|Alogliptin + Other|Alogliptin 25 mg, tablets, orally, once daily for up to 12 months in participants who did not receive a thiazolidinedione within 3 months from the start of administration of alogliptin or during the treatment period of alogliptin.
686088|NCT01945242|E1|Reported Event|Alogliptin + Thiazolidinedione|Alogliptin 25 milligram (mg), tablets, orally, once daily for up to 12 months in participants who received a thiazolidinedione within 3 months from the start of administration of alogliptin and during the treatment period of alogliptin.
686089|NCT01945138|B3|Baseline|Total|Total of all reporting groups
686090|NCT01945138|B2|Baseline|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686091|NCT01945138|B1|Baseline|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686092|NCT01945138|P2|Participant Flow|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686093|NCT01945138|P1|Participant Flow|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686154|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686155|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686094|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686095|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686096|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686097|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686098|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686099|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686100|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686101|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686102|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686103|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686104|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686105|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686106|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686107|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686108|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686109|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686110|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686111|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686112|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686113|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686114|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686115|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686116|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686626|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686118|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686119|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686120|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686121|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686122|NCT01945138|O2|Outcome|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686123|NCT01945138|O1|Outcome|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686124|NCT01945138|E2|Reported Event|Closed Loop Insulin|"Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.~Closed Loop Insulin: The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms)."
686125|NCT01945138|E1|Reported Event|Control|Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
686126|NCT01945112|B1|Baseline|Paper Tape|Paper was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
686127|NCT01945112|P2|Participant Flow|Paper Tape on Left and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
686128|NCT01945112|P1|Participant Flow|Paper Tape on Right and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
686129|NCT01945112|O1|Outcome|Paper Tape|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
686130|NCT01945112|E2|Reported Event|Tape on Left Foot and No Tape on Right Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
686131|NCT01945112|E1|Reported Event|Paper Tape on RIght Foot and No Tape on Left Foot|Paper tape was applied to study participants' blister prone areas or a randomly selected spot (if no blister history on that foot) - with untaped areas of the same foot as control.
686132|NCT01945086|B4|Baseline|Total|Total of all reporting groups
686133|NCT01945086|B3|Baseline|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686134|NCT01945086|B2|Baseline|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686135|NCT01945086|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686136|NCT01945086|P3|Participant Flow|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686137|NCT01945086|P2|Participant Flow|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686138|NCT01945086|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686139|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686140|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686141|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686142|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686143|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686144|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686145|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686146|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686147|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686148|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686149|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686150|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686151|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686152|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686153|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686157|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686158|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686159|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686160|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686161|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686162|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686163|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686164|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686165|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686166|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686167|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686168|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686169|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686170|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686171|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686172|NCT01945086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686173|NCT01945086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686174|NCT01945086|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686175|NCT01945086|E3|Reported Event|Ustekinumab 90 mg|Participants received subcutaneous (SC) injections of ustekinumab 90 mg at Week 0 and Week 4.
686176|NCT01945086|E2|Reported Event|Ustekinumab 45 mg|Participants received subcutaneous (SC) injections of ustekinumab 45 milligram (mg) at Week 0 and Week 4.
686177|NCT01945086|E1|Reported Event|Placebo|Participants received subcutaneous (SC) injections of placebo at Week 0 and Week 4.
686178|NCT01945034|B4|Baseline|Total|Total of all reporting groups
686179|NCT01945034|B3|Baseline|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686180|NCT01945034|B2|Baseline|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686181|NCT01945034|B1|Baseline|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686182|NCT01945034|P3|Participant Flow|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686183|NCT01945034|P2|Participant Flow|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686184|NCT01945034|P1|Participant Flow|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686185|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686186|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686187|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686188|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686189|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686190|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686191|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686192|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686627|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686294|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686193|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686194|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686195|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686196|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686197|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686198|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686199|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686200|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686201|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686202|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686203|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686204|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686205|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686206|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686207|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686208|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686209|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686210|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686211|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686212|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686213|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686214|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686215|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686216|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686217|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686218|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686292|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686219|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686220|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686221|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686222|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686223|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686224|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686225|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686226|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686227|NCT01945034|O3|Outcome|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686228|NCT01945034|O2|Outcome|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686229|NCT01945034|O1|Outcome|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686230|NCT01945034|E3|Reported Event|Placebo Combined|Placebo matched to Ibuprofen twice daily or thrice daily regimen was applied for first 7 days.
686231|NCT01945034|E2|Reported Event|Ibuprofen Thrice Daily|Ibuprofen 5% Topical Gel thrice a day was applied topically as a 4-inch strip approximately every 6 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686232|NCT01945034|E1|Reported Event|Ibuprofen Twice Daily|Ibuprofen 5 percent (%) topical gel twice daily was applied topically as a 4-inch strip approximately every 12 hours, for the first 7 days. Subsequently, on Days 8 through 10, participants were permitted to use the study medication on an optional basis, according to the assigned dosing regimen.
686233|NCT01945021|B1|Baseline|Crizotinib|Single arm trial whereby all consented, enrolled, eligible patients receive crizotinib
686234|NCT01945021|P1|Participant Flow|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
686235|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
686236|NCT01945021|O1|Outcome|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
686237|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) included all enrolled patients who receive at least one dose of study medication. (n=127).
686238|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
686239|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
686240|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
686241|NCT01945021|O1|Outcome|Safety Evaluable Population|The safety analysis population (SAF) will include all enrolled patients who receive at least one dose of study medication. (n=127).
686242|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
686243|NCT01945021|O1|Outcome|Participants With Objective Response by Independent Review|Defined as all patients in the safety analysis population who have an adequate baseline tumor assessment and an objective response determined by Independent Review (n=88).
686244|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
686245|NCT01945021|O1|Outcome|Response Evaluable Population|The response-evaluable population (RES) is defined as all patients in the safety analysis population who have an adequate baseline tumor assessment (n=127).
686246|NCT01945021|E1|Reported Event|Crizotinib|Single-arm trial whereby all consented, enrolled, eligible patients receive crizotinib
686247|NCT01944969|B1|Baseline|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686248|NCT01944969|P1|Participant Flow|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686293|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686249|NCT01944969|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686250|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686251|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686252|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686253|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1,2, or 3 mg/day, once daily dose, tablets, orally"
686254|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686255|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686256|NCT01944969|O1|Outcome|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686257|NCT01944969|E1|Reported Event|Brexpiprazole and ADT|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1, 2, or 3 mg/day, once daily dose, tablets, orally"
686258|NCT01944878|B3|Baseline|Total|Total of all reporting groups
686259|NCT01944878|B2|Baseline|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686260|NCT01944878|B1|Baseline|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686261|NCT01944878|P2|Participant Flow|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686262|NCT01944878|P1|Participant Flow|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686263|NCT01944878|O2|Outcome|No PUD in Lchronic Hepatitis|
686264|NCT01944878|O1|Outcome|PUD in Chronic Hepatitis|
686265|NCT01944878|O2|Outcome|No PUD in Liver Cirrhosis|Patients without PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686266|NCT01944878|O1|Outcome|PUD in Liver Cirrhosis|Patients with PUD in liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686267|NCT01944878|E2|Reported Event|Patients With Liver Cirrhosis|Patients with liver cirrhosis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686268|NCT01944878|E1|Reported Event|Patients With Chronic Hepatitis|Patients with chronic hepatitis, who experienced HVPG measurement via transjugular approach and EGD within 3 months of HVPG measurement
686269|NCT01944774|B4|Baseline|Total|Total of all reporting groups
686270|NCT01944774|B3|Baseline|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686271|NCT01944774|B2|Baseline|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686272|NCT01944774|B1|Baseline|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686273|NCT01944774|P3|Participant Flow|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686274|NCT01944774|P2|Participant Flow|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686275|NCT01944774|P1|Participant Flow|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686276|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686277|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686278|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686279|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686280|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686281|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686282|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686283|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686284|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686285|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686286|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686287|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686288|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686289|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686290|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686291|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686295|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686296|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686297|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686298|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686299|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686300|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
686301|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
686302|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
686303|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
686304|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
686305|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
686306|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
686307|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
686308|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
686309|NCT01944774|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg/250mL Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days
686310|NCT01944774|O2|Outcome|Nemonoxacin 650 mg|Nemonoxacin 650 mg/325mL Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days
686311|NCT01944774|O1|Outcome|Nemonoxacin 500 mg|Nemonoxacin 500mg/250mL. Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days
686312|NCT01944774|E3|Reported Event|Moxifloxacin 400 mg|"Moxifloxacin 400mg/250mL~Moxifloxacin 400 mg: IV Infusion, once daily for 7~14 days"
686313|NCT01944774|E2|Reported Event|Nemonoxacin 650 mg|"Nemonoxacin 650 mg/325mL~Nemonoxacin 650 mg: IV Infusion, once daily for 7~14 days"
686314|NCT01944774|E1|Reported Event|Nemonoxacin 500 mg|"Nemonoxacin 500mg/250mL.~Nemonoxacin 500 mg: IV Infusion, once daily for 7~14 days"
686315|NCT01944670|B1|Baseline|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
686316|NCT01944670|P1|Participant Flow|Internal Joint Stabilizer Group|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
686317|NCT01944670|O1|Outcome|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
686318|NCT01944670|O1|Outcome|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
686319|NCT01944670|E1|Reported Event|Participants Who Completed the Study|"Patients implanted with the Internal Joint Stabilizer - Elbow (IJS-E) who completed the study (have final follow-up data)~Internal Joint Stabilizer - Elbow (IJS-E): Device designed for internal stabilization of the elbow"
686320|NCT01944631|B3|Baseline|Total|Total of all reporting groups
686321|NCT01944631|B2|Baseline|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686322|NCT01944631|B1|Baseline|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686323|NCT01944631|P2|Participant Flow|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686324|NCT01944631|P1|Participant Flow|Placebo|Patients received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686325|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686326|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686327|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686328|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686329|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686330|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686331|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686332|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686333|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
724315|NCT01717989|O3|Outcome|Q2 2011|Second quarter, 2011
686634|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
729491|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
686334|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686335|NCT01944631|O2|Outcome|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686336|NCT01944631|O1|Outcome|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686337|NCT01944631|E2|Reported Event|Bisolviral|Patients received an application of 1.20g/l Iota-Carrageenan in saline nasal spray 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686338|NCT01944631|E1|Reported Event|Placebo|Patient received an application of placebo nasal spray saline 4 times a day, for 4 to 10 days. One application means one puff into each nostril.
686339|NCT01944345|B1|Baseline|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
686340|NCT01944345|P1|Participant Flow|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
686341|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
686342|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
686343|NCT01944345|O1|Outcome|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
686344|NCT01944345|E1|Reported Event|Registry Patients|Any patients undergoing lumbar or cervical fusion using the VariLift device in an inpatient or outpatient setting.
686345|NCT01944319|B3|Baseline|Total|Total of all reporting groups
686346|NCT01944319|B2|Baseline|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
686347|NCT01944319|B1|Baseline|Control Group|Meropenem therapy with regimen routinely decided by attending physician
686348|NCT01944319|P2|Participant Flow|Study Group|"Patients in Study group will accept meropenem therapy based on PPK and PD parameter.~Meropenem therapy based on PPK and PD: Meropenem therapy with regimen decided by a software developed from a PPK model and clinical PD parameter"
686349|NCT01944319|P1|Participant Flow|Control Group|Meropenem therapy with regimen routinely decided by attending physician
686350|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
686351|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
686352|NCT01944319|O2|Outcome|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
686353|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
686354|NCT01944319|O2|Outcome|Study Group|The participants in stusy group will accept meropenem therapy based on a PPK and PD model.
686355|NCT01944319|O1|Outcome|Control Group|The participants in control group will accept routine meropenem therapy.
686356|NCT01944319|E2|Reported Event|Study Group|The participants in study group will accept meropenem therapy based on a PPK and PD model.
686357|NCT01944319|E1|Reported Event|Control Group|The participants in control group will accept routine meropenem therapy.
686358|NCT01944059|B1|Baseline|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
686359|NCT01944059|P1|Participant Flow|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
686360|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
686361|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
686362|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
686363|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
686364|NCT01944059|O2|Outcome|Placebo (L-alanine)|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Placebo (l-alanine): Theramine like placebo comparator"
686411|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686365|NCT01944059|O1|Outcome|Theramine|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors."
686366|NCT01944059|E1|Reported Event|All Participants|"2 capsules before breakfast and dinner (BID) for 16 weeks.~Migraine preventative medications will be permitted, but no changes in dosage will be allowed during the four month study. Migraine abortive meds will be permitted and will be administered per their standard routine.~Theramine (medical food/old drug): Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.~Placebo (l-alanine): Theramine like placebo comparator"
686367|NCT01943864|B1|Baseline|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686368|NCT01943864|P1|Participant Flow|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686369|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686370|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686371|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686372|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686373|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686374|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686375|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686376|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686377|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686378|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686379|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686380|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686381|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686382|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686412|NCT01943552|E2|Reported Event|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686628|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686383|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686384|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686385|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686386|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686387|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686388|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686389|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686390|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686391|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686392|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686393|NCT01943864|O1|Outcome|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686394|NCT01943864|E1|Reported Event|GSK1120212 2 mg|Participants received GSK1120212 at 2 milligram (mg), either as four tablets of 0.5 mg or one tablet of 2 mg at Day 1. At Day 2 and for the remaining study period, participants received continuous daily dosing of one tablet of 2 mg GSK1120212 once-daily until disease progression or death or until study treatment stopping criteria was met.
686395|NCT01943552|B3|Baseline|Total|Total of all reporting groups
686396|NCT01943552|B2|Baseline|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686397|NCT01943552|B1|Baseline|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686398|NCT01943552|P2|Participant Flow|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686399|NCT01943552|P1|Participant Flow|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686400|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686401|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686402|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686403|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686404|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686405|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686406|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686407|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686408|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686409|NCT01943552|O1|Outcome|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686410|NCT01943552|O2|Outcome|Placebo|4 milliliter (ml) normal saline was administered orally via nebulizer four times a day up to 11 days.
686629|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
686413|NCT01943552|E1|Reported Event|Nebulized Ipratropium Bromide|500 microgram (mcg) ipratropium bromide solution was administered orally via nebulizer four times a day up to 11 days.
686414|NCT01943474|B3|Baseline|Total|Total of all reporting groups
686415|NCT01943474|B2|Baseline|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686416|NCT01943474|B1|Baseline|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686417|NCT01943474|P2|Participant Flow|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686418|NCT01943474|P1|Participant Flow|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686419|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686420|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686421|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686422|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686423|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686424|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686425|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686426|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686427|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686428|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686429|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686430|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686431|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686432|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686497|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole:2-3 mg/day, once daily dose, tablets, for oral use"
686433|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686434|NCT01943474|O2|Outcome|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686435|NCT01943474|O1|Outcome|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686436|NCT01943474|E2|Reported Event|Conventional IV Catheter Device|"Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Interventions include vascular access, administration of fluids, and removal of blood samples.~Conventional IV Catheter Device: Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples."
686437|NCT01943474|E1|Reported Event|AccuCath IV Catheter Device|"AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal~AccuCath IV Catheter Device: Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples."
686438|NCT01943435|B4|Baseline|Total|Total of all reporting groups
686439|NCT01943435|B3|Baseline|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
686440|NCT01943435|B2|Baseline|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
686441|NCT01943435|B1|Baseline|Usual Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient.~Lumbar epidural injection: these will be prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications.~NSAIDs; adjunctive analgesics; adjunctive anti-depressants: Physician will administer these medications based upon the individual needs of each patient.~Lumbar epidural injection: The attending physician may refer s"
686442|NCT01943435|P3|Participant Flow|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
686443|NCT01943435|P2|Participant Flow|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
686444|NCT01943435|P1|Participant Flow|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
686445|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
686630|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
686446|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
686447|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
686448|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
686449|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
686450|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
686451|NCT01943435|O3|Outcome|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations.~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
686452|NCT01943435|O2|Outcome|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
686453|NCT01943435|O1|Outcome|Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following:~NSAIDs, Adjunctive analgesics, antidepressants,~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
686454|NCT01943435|E3|Reported Event|Manual Therapy and Exercise|"This group of subjects will be treated with a combination of manual therapy and rehabilitative exercise procedures that are commonly used by physical therapists and chiropractors. Subjects will be treated at a frequency of 2 times per week, for a total of 12 visits over the 6-week research period. Treatments provided by licensed physical therapists and chiropractors include:~Manual Therapy: Joint mobilizations of the lumbar spine, sacroiliac, and/or hip joints, as well as muscle stretching and neural mobilizations~Rehabilitative exercises: exercises will be tailored to the individual needs of each research participant by the treating physical therapist or chiropractor."
686455|NCT01943435|E2|Reported Event|Group Exercise|"Group Exercise: community setting. This arm will involve attendance at community based group exercise classes that are taught by senior physical fitness instructors. These classes are designed specifically for older adults. Exercise frequency will be 2 times per week, for a total of 12 visits over the 6-week research period. These exercise classes will be attended at local community senior centers which cater to the needs of older adults. The subjects can self-select which particular exercise class they prefer to attend, based upon their level of fitness and physical function.~Group Exercise: community setting: The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers."
686498|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686456|NCT01943435|E1|Reported Event|Usual Medical Care|"Participants assigned to this group will see a board certified physical medicine and rehabilitation physician for a history and examination, after which a determination will be made about a course of treatment that involve medications that are individualized to the needs of each patient. These include any of the following: NSAIDs, Adjunctive analgesics, antidepressants.~Lumbar epidural injection: prescribed by the physician if warranted due to severity of symptoms or lack of adequate response to oral medications. Shared decision making with patient."
686457|NCT01943344|B1|Baseline|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
686458|NCT01943344|P1|Participant Flow|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
686459|NCT01943344|O1|Outcome|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
686460|NCT01943344|E1|Reported Event|Treatment|"Subjects that receive VIVASURE CLOSURE DEVICE™~VIVASURE CLOSURE DEVICE™: implantation of VIVASURE CLOSURE DEVICE™"
686461|NCT01943292|B4|Baseline|Total|Total of all reporting groups
686462|NCT01943292|B3|Baseline|Defactinib 600 mg Bid|600 mg po bid defactinib
686463|NCT01943292|B2|Baseline|Defactinib 400 mg Bid|400 mg po bid defactinib
686464|NCT01943292|B1|Baseline|Defactinib 200 mg Bid|200 mg po bid defactinib
686465|NCT01943292|P3|Participant Flow|Defactinib 600 mg Bid|600 mg bid po defactinib
686466|NCT01943292|P2|Participant Flow|Defactinib 400 mg Bid|400 mg bid po defactinib
686467|NCT01943292|P1|Participant Flow|Defactinib 200 mg Bid|200 mg bid (twice a day) po (by mouth) defactinib
686468|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
686469|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
686470|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
686471|NCT01943292|O3|Outcome|Defactinib 600 mg Bid|600 mg po bid defactinib
686472|NCT01943292|O2|Outcome|Defactinib 400 mg Bid|400 mg po bid defactinib
686473|NCT01943292|O1|Outcome|Defactinib 200 mg Bid|200 mg po bid defactinib
686474|NCT01943292|E3|Reported Event|Defactinib 600 mg Bid|600 mg po bid defactinib
686475|NCT01943292|E2|Reported Event|Defactinib 400 mg Bid|400 mg po bid defactinib
686476|NCT01943292|E1|Reported Event|Defactinib 200 mg Bid|200 mg po bid defactinib
686477|NCT01943110|B1|Baseline|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
686478|NCT01943110|P1|Participant Flow|Saline Injection With ID Adapters|"Each participant will receive six injections of 0.1 ml of sterile saline solution into the skin:~Upper deltoid with the side-load ID adapter~Upper deltoid with the AD ID adapter~Suprascapular (behind the shoulder) with the side-load ID adapter~Suprascapular with the AD ID adapter~Forearm with the side-load ID adapter~Forearm with the AD ID adapter~ID adapter (autodisable): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.~ID adapter (side load): Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin."
686479|NCT01943110|O2|Outcome|SLA ID Adapter|Injections given with the side-load ID adapter
686480|NCT01943110|O1|Outcome|AD ID Adapter|Injections given with the autodisable ID adapter
686481|NCT01943110|O6|Outcome|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
686482|NCT01943110|O5|Outcome|SLA Forearm|Injections given with the side-load ID adapter in the forearm
686483|NCT01943110|O4|Outcome|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
686484|NCT01943110|O3|Outcome|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
686485|NCT01943110|O2|Outcome|ADID Forearm|Injections given with the autodisable ID adapter in the forearm
686486|NCT01943110|O1|Outcome|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
686487|NCT01943110|E6|Reported Event|SLA Suprascapular|Injections given with the side-load ID adapter in the suprascapular region
686488|NCT01943110|E5|Reported Event|SLA Forearm|Injections given with the side-load ID adapter in the forearm region
686489|NCT01943110|E4|Reported Event|SLA Deltoid|Injections given with the side-load ID adapter in the deltoid region
686490|NCT01943110|E3|Reported Event|ADID Suprascapular|Injections given with the autodisable ID adapter in the suprascapular region
686491|NCT01943110|E2|Reported Event|ADID Forearm|Injections given with the autodisable ID adapter in the forearm region
686492|NCT01943110|E1|Reported Event|ADID Deltoid|Injections given with the autodisable ID adapter in the deltoid region
686493|NCT01942785|B1|Baseline|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686494|NCT01942785|P1|Participant Flow|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686495|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
686496|NCT01942785|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use"
686631|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686499|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686500|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686501|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686502|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686503|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686504|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686505|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686506|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686507|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686508|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686509|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686510|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686511|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686512|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686513|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686514|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686515|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686516|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686517|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686518|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686519|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686520|NCT01942785|O1|Outcome|Brexpiprazole|Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use
686521|NCT01942785|E1|Reported Event|Brexpiprazole|Brexpiprazole adjunct to open-label commercially available Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) antidepressant treatment (ADT) Brexpiprazole: 2-3 mg/day, once daily dose, tablets, for oral use
686522|NCT01942733|B1|Baseline|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686523|NCT01942733|P1|Participant Flow|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686524|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686525|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686526|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686527|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686528|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686529|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686530|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686531|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686532|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686533|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686534|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686535|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686536|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686537|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686538|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686539|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686540|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686541|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686542|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686543|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686544|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686545|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686546|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686547|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686548|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686549|NCT01942733|O1|Outcome|Brexpiprazole|"Brexpiprazole adjunct to open-label treatment with a commercially available antidepressant treatment (ADT)~Brexpiprazole: 2-3 mg/day, once daily, tablets, for oral use"
686550|NCT01942733|E1|Reported Event|Brexpiprazole|The all-patients-treated set (APTS) comprises all patients who took at least one dose of brexpiprazole.
686551|NCT01942720|B1|Baseline|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686552|NCT01942720|P1|Participant Flow|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686553|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686554|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686555|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686556|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686557|NCT01942720|O1|Outcome|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686558|NCT01942720|E1|Reported Event|Capsule Endoscopy|Capsule endoscopy and Ileocolonoscopy tests
686559|NCT01942135|B3|Baseline|Total|Total of all reporting groups
686560|NCT01942135|B2|Baseline|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686561|NCT01942135|B1|Baseline|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686562|NCT01942135|P2|Participant Flow|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686563|NCT01942135|P1|Participant Flow|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686564|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686565|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686566|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686567|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686568|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686569|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686570|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686571|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686572|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686573|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686574|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686575|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686576|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686618|NCT01941498|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686632|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686577|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686578|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686579|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686580|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686581|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686582|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686583|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686584|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686585|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686586|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686587|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686588|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686589|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686619|NCT01941498|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686590|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686591|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686592|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686593|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686594|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686595|NCT01942135|O2|Outcome|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686596|NCT01942135|O1|Outcome|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686597|NCT01942135|E2|Reported Event|Placebo + Fulvestrant|Participants were administered placebo orally continuously dosed for 3 weeks followed by 1 week off; repeated at each subsequent cycle and Fulvestrant 500 mg intramuscularly on Days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686598|NCT01942135|E1|Reported Event|Palbociclib + Fulvestrant|Participants were administered an initial dose of 125 mg per day orally continuously for 3 weeks followed by 1 week off that can be reduced to 100 mg or 75 mg in case of toxicity; repeated at each subsequent cycle and fulvestrant 500 mg intramuscularly on days 1 and 15 of cycle 1 and then every 28 days. Pre- and perimenopausal women received goserelin at least 4 weeks before study treatment start and continued receiving concurrent ovarian function suppression with goserelin administered subcutaneously every 28 days during the active treatment phase.
686599|NCT01941940|B1|Baseline|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686600|NCT01941940|P1|Participant Flow|Tocilizumab|Tocilizumab at a fixed dose of 162 milligrams (mg) was administered as subcutaneous (SC) injection alone or along with methotrexate and/or other non-biological Disease-Modifying Antirheumatic Drugs (DMARDs) irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686601|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686602|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686603|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686604|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686605|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686606|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686607|NCT01941940|O1|Outcome|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it became commercially available in Italy (maximum up to 2 years and 10 months).
686608|NCT01941940|E1|Reported Event|Tocilizumab|Tocilizumab at a fixed dose of 162 mg was administered as SC injection alone or along with methotrexate and/or other non-biological DMARDs irrespective of body weight, once every week for a total of 52 weeks. After 52-weeks of treatment, at the discretion of the treating physician, participants could continue the study treatment with SC tocilizumab until it become commercially available in Italy (maximum up to 2 years and 10 months).
686609|NCT01941615|B1|Baseline|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686610|NCT01941615|P1|Participant Flow|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686611|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686612|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686613|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686614|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686615|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686616|NCT01941615|O1|Outcome|Deleobuvir + Faldaprevir + Microgynon|This was an open-label, 2-period, fixed-sequence study. After a run-in period of 28 to 56 days (treatment with Microgynon® once daily for 21 to 49 days, depending on the menstrual cycle, followed by a tablet-free interval of 7 days), subjects were to begin the first (reference) treatment period of Microgynon® alone for 13 days, immediately (without washout) followed by the second (test) treatment period of Microgynon® plus deleobuvir+faldaprevir for 10 days.
686617|NCT01941615|E1|Reported Event|Deleobuvir + Faldaprevir + Microgynon|"In the run-in period starting between Day -56 and Day -28, all subjects were to take 1 Microgynon® tablet (combined oral contraceptive ethinylestradiol / levonorgestrel) once daily for 21 to 49 days (depending on the menstrual cycle) until Day -8.~In the last 7 days of the run-in period (Day -7 to Day -1), no treatment was given in order to induce withdrawal bleeding. The next day was to be Day 1 of the study. Subjects who were using oral contraceptives before the study started the run-in period after the usual tablet-free interval of 7 days.~Subjects who were using hormonal contraceptive vaginal rings before the study started the run-in-period after the usual hormone-free interval of 7 days."
686620|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686635|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686636|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
686637|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686638|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686639|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
686640|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686641|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686642|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
686643|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686644|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686645|NCT01941498|O1|Outcome|Baseline (Day 0)|WaveLight Refractive Suite
686646|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686647|NCT01941498|O2|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal ablation
686648|NCT01941498|O1|Outcome|EX500 Laser|Excimer 500 laser used during LASIK surgery for corneal ablation
686649|NCT01941498|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686650|NCT01941498|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686651|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686652|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686653|NCT01941498|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686654|NCT01941498|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686655|NCT01941498|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686656|NCT01941498|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
686657|NCT01941498|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686658|NCT01941498|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686659|NCT01941498|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686660|NCT01941498|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
686661|NCT01941498|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686662|NCT01941498|E2|Reported Event|Screen Failure|Prior to treatment
686663|NCT01941498|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
686664|NCT01941485|B1|Baseline|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686665|NCT01941485|P1|Participant Flow|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686666|NCT01941485|O1|Outcome|Angles|WaveLight Refractive Suite
686667|NCT01941485|O1|Outcome|AC Depth|WaveLight Refractive Suite
686668|NCT01941485|O1|Outcome|AC Volume|WaveLight Refractive Suite
686669|NCT01941485|O1|Outcome|Q-Value|WaveLight Refractive Suite
686670|NCT01941485|O1|Outcome|FS200 Laser|Femtosecond FS200 laser used during LASIK surgery for corneal flap creation
686671|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686672|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686673|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686674|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686675|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686676|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686677|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686678|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686679|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686680|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686681|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686682|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686683|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686684|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686685|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686686|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686687|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686688|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686689|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686690|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686691|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686692|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686693|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686694|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686695|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686696|NCT01941485|O4|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686697|NCT01941485|O3|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686698|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686699|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
686700|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686701|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686702|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686703|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686704|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
686705|NCT01941485|O1|Outcome|Operation/Surgery (Day 1)|WaveLight Refractive Suite
686706|NCT01941485|O5|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686707|NCT01941485|O4|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686708|NCT01941485|O3|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686709|NCT01941485|O2|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686710|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686711|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686712|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686713|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686714|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686715|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686716|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686717|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
686718|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686719|NCT01941485|O6|Outcome|Month 12 Postoperative|WaveLight Refractive Suite
686720|NCT01941485|O5|Outcome|Month 6 Postoperative|WaveLight Refractive Suite
686721|NCT01941485|O4|Outcome|Month 3 Postoperative|WaveLight Refractive Suite
686722|NCT01941485|O3|Outcome|Month 1 Postoperative|WaveLight Refractive Suite
686723|NCT01941485|O2|Outcome|Day 1 Postoperative|WaveLight Refractive Suite
686724|NCT01941485|O1|Outcome|Baseline/Screening (Day 0)|WaveLight Refractive Suite
686725|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686726|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686727|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686728|NCT01941485|O1|Outcome|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686729|NCT01941485|E1|Reported Event|WaveLight Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers used during LASIK surgery for corneal flap creation and corneal ablation
686730|NCT01941472|B1|Baseline|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
686731|NCT01941472|P1|Participant Flow|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
686732|NCT01941472|O1|Outcome|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
686733|NCT01941472|E1|Reported Event|Septic Shock|Adult patients (at least 18 years of age) with refractory hypotension secondary to sepsis who, at the discretion of treating physicians, required fluid challenge in the presence of invasive hemodynamic monitoring. Refractory hypotension was defined as need of vasopressors to maintain systolic blood pressure (SBP) no less than 90 mmHg despite adequate fluid resuscitation.
686734|NCT01941186|B3|Baseline|Total|Total of all reporting groups
686735|NCT01941186|B2|Baseline|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
686736|NCT01941186|B1|Baseline|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686737|NCT01941186|P2|Participant Flow|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
686738|NCT01941186|P1|Participant Flow|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686739|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
686740|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686741|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
686864|NCT01940146|P4|Participant Flow|SPARC1310 III|SPARC1310 III was administered as two sprays/nostril QD
686865|NCT01940146|P3|Participant Flow|SPARC1310 II|SPARC1310 II was administered as two sprays/nostril QD
686867|NCT01940146|P1|Participant Flow|SPARC Placebo|SPARC Placebo was administered as sprays/nostril QD
686742|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686743|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
686744|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686745|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control arm received routine care, in this case, a handout explaining Early Intervention services.
686746|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686747|NCT01941186|O12|Outcome|Routine Care: Strongly Agree|"Percentage of parents who answered strongly agree to questions during pre and post intervention"
686748|NCT01941186|O11|Outcome|Routine Care: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
686749|NCT01941186|O10|Outcome|Routine Care: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention."
686750|NCT01941186|O9|Outcome|Routine Care: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post intervention"
686751|NCT01941186|O8|Outcome|Routine Care: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
686752|NCT01941186|O7|Outcome|Routine Care: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
686753|NCT01941186|O6|Outcome|Patient Decision Aid: Strongly Agree|"Percentage of parents who answered Strongly Agree to questions during pre and post intervention"
686754|NCT01941186|O5|Outcome|Patient Decision Aid: Agree|"Percentage of parents who answered agree to questions during pre and post intervention"
686755|NCT01941186|O4|Outcome|Patient Decision Aid: Somewhat Agree|"Percentage of parents who answered somewhat agree to questions during pre and post intervention"
686756|NCT01941186|O3|Outcome|Patient Decision Aid: Somewhat Disagree|"Percentage of parents who answered somewhat disagree to questions during pre and post"
686757|NCT01941186|O2|Outcome|Patient Decision Aid: Disagree|"Percentage of parents who answered disagree to questions during pre and post intervention"
686758|NCT01941186|O1|Outcome|Patient Decision Aid: Strongly Disagree|"Percentage of parents who answered strongly disagree to questions during pre and post intervention"
686759|NCT01941186|O2|Outcome|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
686760|NCT01941186|O1|Outcome|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686761|NCT01941186|E2|Reported Event|Routine Care|After screening positive for a potential development delay those in the control received routine care, in this case, a handout explaining Early Intervention services.
686762|NCT01941186|E1|Reported Event|Patient Decision Aid|"After positive screen for a developmental concern the intervention group received the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.~Patient Decision Aid: Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services."
686763|NCT01940523|B3|Baseline|Total|Total of all reporting groups
686764|NCT01940523|B2|Baseline|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
686765|NCT01940523|B1|Baseline|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
686766|NCT01940523|P2|Participant Flow|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
686818|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686767|NCT01940523|P1|Participant Flow|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. Tourniquet will be released.~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m)."
686768|NCT01940523|O2|Outcome|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
686769|NCT01940523|O1|Outcome|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
686770|NCT01940523|O2|Outcome|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
686771|NCT01940523|O1|Outcome|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
686772|NCT01940523|E2|Reported Event|Intravenous Tranexamic Acid|"1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.~Intravenous Tranexamic Acid: 1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure."
686773|NCT01940523|E1|Reported Event|Topical Tranexamic Acid|"3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m).~Topical Tranexamic Acid: 3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes."
686774|NCT01940510|B1|Baseline|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally alone on Day 1 (Period 1), with rifampin (600 mg capsules orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
686775|NCT01940510|P1|Participant Flow|Whole Study: Alectinib + Rifampin|There were 3 dosing periods in the study: Period 1 (Days 1 to 7), Period 2 (Days 8 to 16), and Period 3 (Days 17 to 21). Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib (RO5424802) 600 milligram (mg) capsules (four 150 mg capsules) orally alone on Day 1 (Period 1), with rifampin (600 mg capsules [two 300 mg capsules] orally) on Day 17 (Period 3), and rifampin alone was administered from Days 8 through 16 (Period 2) and from Days 18 through 20 (Period 3).
686776|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686777|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686819|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686866|NCT01940146|P2|Participant Flow|SPARC1310 I|SPARC1310 I was administered as two sprays /nostril QD
686778|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686779|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686780|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686781|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686782|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686783|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686784|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686785|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686786|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686787|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686788|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686789|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686790|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686791|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686792|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686793|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686794|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686795|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686859|NCT01940146|B5|Baseline|Total|Total of all reporting groups
686860|NCT01940146|B4|Baseline|SPARC1310 III|S0597 high dose: S0597 high dose
686861|NCT01940146|B3|Baseline|SPARC1310 II|S0597 mid dose: S0597 mid dose
686796|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686797|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686798|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686799|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686800|NCT01940510|O2|Outcome|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686801|NCT01940510|O1|Outcome|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686802|NCT01940510|E3|Reported Event|Treatment Period 3: Alectinib + Rifampin|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 3 (Day 17). Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 18 through 20. On Day 17, rifampin was coadministered with alectinib, 30 minutes after start of the standard meal.
686803|NCT01940510|E2|Reported Event|Treatment Period 2: Rifampin|Participants following an overnight fast of at least 10 hours received rifampin 600 mg capsules orally once daily from Day 8 through 16.
686804|NCT01940510|E1|Reported Event|Treatment Period 1: Alectinib|Participants following an overnight fast of at least 10 hours ate a standard meal in 30 minutes or less and 30 minutes after start of the meal received alectinib 600 mg capsules orally on Day 1 of treatment period 1.
686805|NCT01940484|B1|Baseline|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686806|NCT01940484|P1|Participant Flow|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta (Mircera) as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686807|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686808|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686809|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686810|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686811|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686812|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686813|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686814|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686815|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686816|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686817|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686820|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686821|NCT01940484|O1|Outcome|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686822|NCT01940484|E1|Reported Event|Chronic Renal Anemia Participants|Participants with chronic kidney disease and who were on hemodialysis and prescribed methoxy polyethylene glycol epoetin beta as per physician's discretion for treatment of chronic renal anemia were observed for a period of 6-12 months.
686823|NCT01940471|B3|Baseline|Total|Total of all reporting groups
686824|NCT01940471|B2|Baseline|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686825|NCT01940471|B1|Baseline|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686826|NCT01940471|P2|Participant Flow|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686827|NCT01940471|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg tablet + tenofovir disoproxil fumarate (Viread®; TDF) placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686828|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686829|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686830|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686831|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686832|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686833|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686834|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686835|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686836|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686837|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686838|NCT01940471|O2|Outcome|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks per amendment 1 & 2) or 144 weeks (per amendment 3)
686839|NCT01940471|O1|Outcome|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686840|NCT01940471|E2|Reported Event|TDF 300 mg|TDF 300 mg tablet + TAF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686841|NCT01940471|E1|Reported Event|TAF 25 mg|TAF 25 mg tablet + TDF placebo tablet once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686842|NCT01940341|B3|Baseline|Total|Total of all reporting groups
686843|NCT01940341|B2|Baseline|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686844|NCT01940341|B1|Baseline|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686845|NCT01940341|P2|Participant Flow|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686846|NCT01940341|P1|Participant Flow|TAF 25 mg|Tenofovir alafenamide (Vemlidy®; TAF) 25 mg + tenofovir disoproxil fumarate (TDF) placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686847|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686848|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686849|NCT01940341|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686850|NCT01940341|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686851|NCT01940341|O2|Outcome|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686852|NCT01940341|O1|Outcome|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686853|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686854|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686855|NCT01940341|O2|Outcome|TDF + TAF Placebo|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686856|NCT01940341|O1|Outcome|TAF + TDF Placebo|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686857|NCT01940341|E2|Reported Event|TDF 300 mg|TDF 300 mg + TAF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686858|NCT01940341|E1|Reported Event|TAF 25 mg|TAF 25 mg + TDF placebo tablets administered once daily for up to 96 weeks (per amendment 1 & 2) or 144 weeks (per amendment 3)
686868|NCT01940146|O4|Outcome|S0597 High Dose|S0597 high dose: S0597 high dose
686869|NCT01940146|O3|Outcome|S0597 Mid Dose|S0597 mid dose: S0597 mid dose
686870|NCT01940146|O2|Outcome|S0597 Low Dose|S0597 low dose: S0597 low dose
686871|NCT01940146|O1|Outcome|Placebo|Placebo: Placebo
686872|NCT01940146|E4|Reported Event|SPARC1310 III|SPARC1310 III administration
686873|NCT01940146|E3|Reported Event|SPARC1310 II|SPARC1310 II administration
686874|NCT01940146|E2|Reported Event|SPARC1310 I|SPARC1310 I administration
686875|NCT01940146|E1|Reported Event|SPARC Placebo|SPARC Placebo administration
686876|NCT01940120|B1|Baseline|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686877|NCT01940120|P1|Participant Flow|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686878|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686879|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686880|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686881|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686882|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686883|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686884|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686885|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686886|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686887|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686888|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686889|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686890|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686891|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686892|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
688064|NCT01937130|E3|Reported Event|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
686893|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686894|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686895|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686896|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686897|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686898|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686899|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686900|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686901|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686902|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686903|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686904|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686905|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686906|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686907|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686908|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686909|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686910|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686911|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
687130|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
686912|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686913|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686914|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686915|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686916|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686917|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686918|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686919|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686920|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686921|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686922|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686923|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686924|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686925|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686926|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686927|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686928|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686929|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686930|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
687616|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
686931|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686932|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686933|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686934|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686935|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686936|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686937|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686938|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686939|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686940|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686941|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686942|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686943|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686944|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686945|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686946|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686947|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686948|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686949|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
687617|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
686950|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686951|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686952|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686953|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686954|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686955|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686956|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686957|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686958|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686959|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686960|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686961|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686962|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686963|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686964|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686965|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686966|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686967|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686968|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
687618|NCT01938040|O2|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
686969|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686970|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686971|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686972|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686973|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686974|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686975|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686976|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686977|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686978|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686979|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686980|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686981|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686982|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686983|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686984|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686985|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686986|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686987|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
687619|NCT01938040|O1|Outcome|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
686988|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686989|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686990|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686991|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686992|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686993|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686994|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686995|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686996|NCT01940120|O1|Outcome|High Risk Registry Arm|Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.
686997|NCT01940120|E1|Reported Event|High Risk Registry Arm|"Includes patients with a predicted procedural mortality of 12% or higher. The high risk registry arm of the study is powered to show superiority of safety of treatment with the MitraClip compared to mitral valve surgery. The patients who are enrolled in this arm will undergo percutaneous mitral valve repair using MitraClip implant.~Percutaneous mitral valve repair using MitraClip implant: Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve"
686998|NCT01939938|B1|Baseline|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
686999|NCT01939938|P1|Participant Flow|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
687000|NCT01939938|O2|Outcome|Residual AHI|AHI residual.
687001|NCT01939938|O1|Outcome|Baseline AHI|AHI at baseline.
687002|NCT01939938|E1|Reported Event|All Subjects-Nasal and Oronasal PAP Mask|"Each subject will be imaged in a dynamic MRI with both a oronasal and nasal mask at pressures of 5, 10, and 15 cm of H2O.~Nasal and Oronasal PAP Mask: Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20."
687003|NCT01939548|B4|Baseline|Total|Total of all reporting groups
687004|NCT01939548|B3|Baseline|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687005|NCT01939548|B2|Baseline|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687006|NCT01939548|B1|Baseline|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687007|NCT01939548|P3|Participant Flow|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687008|NCT01939548|P2|Participant Flow|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687129|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687009|NCT01939548|P1|Participant Flow|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687010|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687011|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687012|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687013|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687014|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687015|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687016|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687017|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687018|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687019|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687020|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687021|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687022|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687023|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687024|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687025|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687026|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687027|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687028|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687029|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687030|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687031|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687032|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687033|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687034|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687035|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687036|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687037|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687038|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687039|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687040|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687041|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687042|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687043|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687044|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687045|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687046|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687047|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687048|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687049|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687050|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687051|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687052|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687053|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687054|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687055|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687056|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687057|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687058|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687059|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687060|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687061|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687062|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687063|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687064|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687065|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687066|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687067|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687068|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687069|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687070|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687071|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687072|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687073|NCT01939548|O3|Outcome|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687074|NCT01939548|O2|Outcome|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687075|NCT01939548|O1|Outcome|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687076|NCT01939548|E3|Reported Event|Placebo|Participants received 3 placebo tablets from Days 1-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687077|NCT01939548|E2|Reported Event|PF-02545920 15 mg BID|Participants received 2 placebo tablets and 1 PF-02545920 5 mg tablet twice daily (BID) from Days 1-7, followed by 1 placebo tablet and 2 PF-02545920 5 mg tablets BID from Days 8-14 (treatment phase), and finally 3 PF-02545920 5 mg tablets from Days 15-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687078|NCT01939548|E1|Reported Event|PF-02545920 5 mg BID|Participants received 1 placebo tablet and 2 PF-02545920 1 mg tablets twice daily (BID) from Days 1-7, followed by 2 placebo tablets and 1 PF-02545920 5 mg tablet BID from Days 8-84 (treatment phase). Study drug was self-administered orally BID by the participants based on instructions given at the sites. Participants took a total of 6 tablets per day (3 each in the morning and evening).
687079|NCT01939496|B4|Baseline|Total|Total of all reporting groups
687080|NCT01939496|B3|Baseline|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687081|NCT01939496|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687082|NCT01939496|B1|Baseline|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687083|NCT01939496|P3|Participant Flow|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687084|NCT01939496|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687085|NCT01939496|P1|Participant Flow|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687086|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687087|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687088|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687089|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687090|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687091|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687092|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687093|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687094|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687095|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687096|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687097|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687098|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687099|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687100|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687101|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687102|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687103|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687104|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687105|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687106|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687107|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687108|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687109|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687110|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687111|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687112|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687113|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687114|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687115|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687116|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687117|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687118|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687119|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687120|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687121|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687122|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687123|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687124|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687125|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687126|NCT01939496|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687127|NCT01939496|O1|Outcome|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687128|NCT01939496|O3|Outcome|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687131|NCT01939496|E3|Reported Event|Canagliflozin 300 mg|Participants were received Canagliflozin 300 mg overencapsulated tablets orally once daily for 6 Weeks.
687132|NCT01939496|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants were received Canagliflozin 100 mg overencapsulated tablets orally once daily for 6 Weeks.
687133|NCT01939496|E1|Reported Event|Placebo|Participants were received matching placebo overencapsulated tablets orally once daily for 6 Weeks.
687134|NCT01939314|B3|Baseline|Total|Total of all reporting groups
687135|NCT01939314|B2|Baseline|Normal Saline|Normal Saline delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
687136|NCT01939314|B1|Baseline|Bupivacaine|Bupivacaine delivered by the Tx 360 device to the sphenopalatine ganglion bilaterally
687137|NCT01939314|P2|Participant Flow|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
687138|NCT01939314|P1|Participant Flow|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
687139|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
687140|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
687141|NCT01939314|O2|Outcome|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
687142|NCT01939314|O1|Outcome|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
687143|NCT01939314|O2|Outcome|Normal Saline|Normal Saline .03ml to each nare
687144|NCT01939314|O1|Outcome|Bupivacaine|Bupivicaine .03ml to each nare
687145|NCT01939314|E2|Reported Event|Normal Saline|"normal saline .03 ml to each nare~Placebo: Placebo"
687146|NCT01939314|E1|Reported Event|Bupivacaine|"Bupivicaine .03ml to each nare~Bupivacaine: intervention"
687147|NCT01939145|B3|Baseline|Total|Total of all reporting groups
687148|NCT01939145|B2|Baseline|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
687149|NCT01939145|B1|Baseline|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
687150|NCT01939145|P2|Participant Flow|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
687151|NCT01939145|P1|Participant Flow|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
687152|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
687153|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
687154|NCT01939145|O2|Outcome|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
687155|NCT01939145|O1|Outcome|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
687620|NCT01938040|O2|Outcome|Ibuprofen|800 mg in 100mL of normal saline over 5 minutes
687156|NCT01939145|E2|Reported Event|Prontosan|"The use of Prontosan as the solution in Negative Pressure Wound Therapy with Instillation.~Prontosan: Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies."
687157|NCT01939145|E1|Reported Event|Normal Saline|"The use of Normal Saline as the solution for Negative Pressure Wound Therapy with instillation.~Normal saline: Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies"
687158|NCT01939002|B3|Baseline|Total|Total of all reporting groups
687159|NCT01939002|B2|Baseline|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687160|NCT01939002|B1|Baseline|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687161|NCT01939002|P2|Participant Flow|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687162|NCT01939002|P1|Participant Flow|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687163|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687164|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687165|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687166|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687167|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687168|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687169|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
687170|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
687171|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687172|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687173|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687174|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687175|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687176|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687177|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687178|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687179|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687180|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687181|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687182|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687183|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687197|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
724316|NCT01717989|O2|Outcome|Q1 2011|First quarter 2011
687184|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687185|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687186|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687187|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687188|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687189|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687190|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687191|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687192|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687193|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687194|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687195|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687196|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687226|NCT01939002|E1|Reported Event|BIIB017 Plus Current FLS Therapy|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus current FLS management regimen as determined by the clinician
687198|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687199|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687200|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687201|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687202|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687203|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687204|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687205|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687206|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687207|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687208|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687209|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687210|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687225|NCT01939002|E2|Reported Event|BIIB017 Plus Naproxen|BIIB017 initial dose of 63 μg followed by 94 μg dose at week 2 and 125 μg every 2 weeks from week 4 to week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently
724317|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter, 2010
687211|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687212|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687213|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687214|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687215|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687216|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687217|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687218|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687219|NCT01939002|O3|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently"
687220|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687221|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687222|NCT01939002|O2|Outcome|BIIB017 Plus Naproxen|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus 500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently.
687223|NCT01939002|O1|Outcome|BIIB017 Plus Current FLS Therapy|Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus current FLS management regimen as determined by the clinician.
687224|NCT01939002|O1|Outcome|Overall Population|"Following a 4-week run-in period (starting 1 day after the Screening Visit) in which participants administered non-pegylated IFN therapy, participants received BIIB017 at an initial dose of 63 μg followed by 94 μg dose at Week 2 and 125 μg every 2 weeks from Week 4 to Week 46, plus:~current FLS management regimen as determined by the clinician; or~500 mg naproxen administered twice daily up to 24 hours prior to BIIB017 treatment and continuing for 48 hours following the BIIB017 injection for the first 8 weeks of treatment, and as recommended by the treating physician subsequently."
687621|NCT01938040|O1|Outcome|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
687227|NCT01938989|B1|Baseline|Overall|Blue light filter clip-on glasses and clear clip-on glasses worn over habitual correction in a crossover assignment.
687228|NCT01938989|P2|Participant Flow|Blue Light Filter, Then Clear|Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction
687229|NCT01938989|P1|Participant Flow|Clear, Then Blue Light Filter|Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction
687230|NCT01938989|O2|Outcome|Clear|Clear clip-on glasses worn over habitual correction
687231|NCT01938989|O1|Outcome|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
687232|NCT01938989|E2|Reported Event|Clear|Clear clip-on glasses worn over habitual correction
687233|NCT01938989|E1|Reported Event|Blue Light Filter|Blue light filter clip-on glasses worn over habitual correction
687234|NCT01938430|B15|Baseline|Total|Total of all reporting groups
687235|NCT01938430|B14|Baseline|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687236|NCT01938430|B13|Baseline|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687237|NCT01938430|B12|Baseline|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687238|NCT01938430|B11|Baseline|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687239|NCT01938430|B10|Baseline|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687240|NCT01938430|B9|Baseline|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687241|NCT01938430|B8|Baseline|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687242|NCT01938430|B7|Baseline|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687243|NCT01938430|B6|Baseline|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687244|NCT01938430|B5|Baseline|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687245|NCT01938430|B4|Baseline|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687246|NCT01938430|B3|Baseline|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687247|NCT01938430|B2|Baseline|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687248|NCT01938430|B1|Baseline|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687249|NCT01938430|P14|Participant Flow|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687250|NCT01938430|P13|Participant Flow|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687251|NCT01938430|P12|Participant Flow|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687252|NCT01938430|P11|Participant Flow|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687253|NCT01938430|P10|Participant Flow|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687254|NCT01938430|P9|Participant Flow|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687255|NCT01938430|P8|Participant Flow|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687256|NCT01938430|P7|Participant Flow|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687257|NCT01938430|P6|Participant Flow|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687258|NCT01938430|P5|Participant Flow|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|"LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3~F0: no fibrosis; F1: portal fibrosis without septa; F2: portal fibrosis with rare septa, F3: numerous septa without cirrhosis; F4: cirrhosis"
687259|NCT01938430|P4|Participant Flow|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687260|NCT01938430|P3|Participant Flow|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687261|NCT01938430|P2|Participant Flow|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687262|NCT01938430|P1|Participant Flow|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|"Ledipasvir/sofosbuvir (Harvoni®; LDV/SOF) (90/400 mg) fixed-dose combination (FDC) tablet once daily plus ribavirin (RBV) tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with Child-Pugh-Turcotte (CPT) Class B (CPT score 7-9).~CPT scores grade the severity of cirrhosis and are used to determine the need for liver transplantation. Scores can range from 5 to 15 (maximum score for study was 12); higher scores indicate greater severity of disease."
687263|NCT01938430|O11|Outcome|Cohort B: Baseline CPT Class C (24 wk)|Includes participants in Cohort B (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687264|NCT01938430|O10|Outcome|Cohort B: Baseline CPT Class C (12 wk)|Includes participants in Cohort B (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687265|NCT01938430|O9|Outcome|Cohort B: Baseline CPT Class B (24 wk)|Includes participants in Cohort B (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687266|NCT01938430|O8|Outcome|Cohort B: Baseline CPT Class B (12 wk)|Includes participants in Cohort B (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687267|NCT01938430|O7|Outcome|Cohort B: Baseline CPT Class A (24 wk)|Includes participants in Cohort B (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687268|NCT01938430|O6|Outcome|Cohort B: Baseline CPT Class A (12 wk)|Includes participants in Cohort B (12 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687269|NCT01938430|O5|Outcome|Cohort A: Baseline CPT Class C (24 wk)|Includes participants in Cohort A (24 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687270|NCT01938430|O4|Outcome|Cohort A: Baseline CPT Class C (12 wk)|Includes participants in Cohort A (12 wk) with CPT score C at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687271|NCT01938430|O3|Outcome|Cohort A: Baseline CPT Class B (24 wk)|Includes participants in Cohort A (24 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687272|NCT01938430|O2|Outcome|Cohort A: Baseline CPT Class B (12 wk)|Includes participants in Cohort A (12 wk) with CPT score B at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687273|NCT01938430|O1|Outcome|Cohort A: Baseline CPT Class A (24 wk)|Includes participants in Cohort A (24 wk) with CPT score A at baseline (randomization was based on screening measurement), and who had CPT score assessments at both baseline and Posttreatment Week 4.
687274|NCT01938430|O10|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687275|NCT01938430|O9|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687276|NCT01938430|O8|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687277|NCT01938430|O7|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
688039|NCT01937130|P3|Participant Flow|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
687278|NCT01938430|O6|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687279|NCT01938430|O5|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687280|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687281|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687282|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687283|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687284|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687285|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687286|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687287|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687288|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687289|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687290|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687291|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687292|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687293|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687294|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687295|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687296|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687297|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687298|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687299|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687300|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687347|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687301|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687302|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687303|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687304|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687305|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687306|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687307|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687308|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687309|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687310|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687311|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687312|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687313|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687314|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687315|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687316|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687317|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687318|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687319|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687320|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687321|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687322|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687323|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687348|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687324|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687325|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687326|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687327|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687328|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687329|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687330|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687331|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687332|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687333|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687334|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687335|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687336|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687337|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687338|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687339|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687340|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687341|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687342|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687343|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687344|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687345|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687346|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687349|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687350|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687351|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687352|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687353|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687354|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687355|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687356|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687357|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687358|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687359|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687360|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687361|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687362|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687363|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687364|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687365|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687366|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687367|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687368|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687369|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687370|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687371|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687372|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687397|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687373|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687374|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687375|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687376|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687377|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687378|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687379|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687380|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687381|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687382|NCT01938430|O7|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687383|NCT01938430|O6|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687384|NCT01938430|O5|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687385|NCT01938430|O4|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687386|NCT01938430|O3|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687387|NCT01938430|O2|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687388|NCT01938430|O1|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687389|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687390|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687391|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687392|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687393|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687394|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687395|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687396|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687398|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687399|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687400|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687401|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687402|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687403|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687404|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687405|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687406|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687407|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687408|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687409|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687410|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687411|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687412|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687413|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687414|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687415|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687416|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687417|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687418|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687419|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687420|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687615|NCT01938040|P1|Participant Flow|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
729313|NCT01697956|B3|Baseline|Total|Total of all reporting groups
687421|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687422|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687423|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687424|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687425|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687426|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687427|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687428|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687429|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687430|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687431|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687432|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687433|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687434|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687435|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687436|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687437|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687438|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687439|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687440|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687441|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687442|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687443|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687468|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687444|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687445|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687446|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687447|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687448|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687449|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687450|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687451|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687452|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687453|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687454|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687455|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687456|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687457|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687458|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687459|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687460|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687461|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687462|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687463|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687464|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687465|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687466|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687467|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687469|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687470|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687471|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687472|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687473|NCT01938430|O1|Outcome|All LDV/SOF+RBV|All participants in the analysis are presented in a single group, regardless of randomization group assignment.
687474|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687475|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687476|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687477|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687478|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687479|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687480|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687481|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687482|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687483|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687484|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687485|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687486|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687487|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687488|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687489|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687490|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687491|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687492|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687493|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687494|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687495|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687496|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687497|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687498|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687499|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687500|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687501|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687502|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687503|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687504|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687505|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687506|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687507|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687508|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687509|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687510|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687511|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687512|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687513|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687514|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687515|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687516|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687517|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687518|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687519|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687520|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687521|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687522|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687523|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687524|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687525|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687526|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687527|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687528|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687529|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687530|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687531|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687532|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687533|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687534|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687535|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687536|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687537|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687538|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687539|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687540|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687541|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687542|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687543|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687544|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687545|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687546|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687547|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687548|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687549|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687550|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687551|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687552|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687553|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687554|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687555|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687556|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687557|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687558|NCT01938430|O14|Outcome|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687559|NCT01938430|O13|Outcome|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687560|NCT01938430|O12|Outcome|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687561|NCT01938430|O11|Outcome|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687562|NCT01938430|O10|Outcome|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687563|NCT01938430|O9|Outcome|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687590|NCT01938170|E1|Reported Event|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
687564|NCT01938430|O8|Outcome|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687565|NCT01938430|O7|Outcome|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687566|NCT01938430|O6|Outcome|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687567|NCT01938430|O5|Outcome|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687568|NCT01938430|O4|Outcome|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687569|NCT01938430|O3|Outcome|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687570|NCT01938430|O2|Outcome|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687571|NCT01938430|O1|Outcome|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687572|NCT01938430|E14|Reported Event|Cohort B, Group 7 (24 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with FCH
687573|NCT01938430|E13|Reported Event|Cohort B, Group 7 (12 wk): FCH|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with fibrosing cholestatic hepatitis (FCH)
687574|NCT01938430|E12|Reported Event|Cohort B, Group 6 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687575|NCT01938430|E11|Reported Event|Cohort B, Group 6 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687576|NCT01938430|E10|Reported Event|Cohort B, Group 5 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687577|NCT01938430|E9|Reported Event|Cohort B, Group 5 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687578|NCT01938430|E8|Reported Event|Cohort B, Group 4 (24 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with CPT Class A (CPT score 5-6)
687579|NCT01938430|E7|Reported Event|Cohort B, Group 4 (12 wk): CPT Class A (5-6)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with CPT Class A (CPT score 5-6)
687580|NCT01938430|E6|Reported Event|Cohort B, Group 3 (24 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 24 weeks in participants with Fibrosis Stage F0-F3
687581|NCT01938430|E5|Reported Event|Cohort B, Group 3 (12 wk): F0-F3 Fibrosis|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (weight-based divided daily dose: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg) for 12 weeks in participants with Fibrosis Stage F0-F3
687582|NCT01938430|E4|Reported Event|Cohort A, Group 2 (24 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class C (CPT score 10-12)
687583|NCT01938430|E3|Reported Event|Cohort A, Group 2 (12 wk): CPT Class C (10-12)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class C (CPT score 10-12)
687584|NCT01938430|E2|Reported Event|Cohort A, Group 1 (24 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 24 weeks in participants with CPT Class B (CPT score 7-9)
687585|NCT01938430|E1|Reported Event|Cohort A, Group 1 (12 wk): CPT Class B (7-9)|LDV/SOF (90/400 mg) FDC tablet once daily plus RBV tablets (divided daily dose starting at 600 mg, then adjusted ± based on tolerability [weight-based maximum: < 75 kg = 1000 mg, ≥ 75 kg = 1200 mg]) for 12 weeks in participants with CPT Class B (CPT score 7-9)
687586|NCT01938170|B1|Baseline|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
687587|NCT01938170|P1|Participant Flow|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
687588|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
687589|NCT01938170|O1|Outcome|FluMist|"Subjects receiving vaccine at home~FluMist: Subjects receiving Flumist vaccine"
687592|NCT01938079|B2|Baseline|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687593|NCT01938079|B1|Baseline|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687594|NCT01938079|P2|Participant Flow|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687595|NCT01938079|P1|Participant Flow|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687596|NCT01938079|O2|Outcome|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687597|NCT01938079|O1|Outcome|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687598|NCT01938079|E2|Reported Event|Sedative With Ketamine|"Subjects will receive sedative drug regimen with Ketamine.~Ketamine: Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687599|NCT01938079|E1|Reported Event|Sedative Without Ketamine|"Subjects will receive sedative drug regimen without Ketamine.~Sedative drug regimen: (Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation."
687600|NCT01938066|B3|Baseline|Total|Total of all reporting groups
687601|NCT01938066|B2|Baseline|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
687602|NCT01938066|B1|Baseline|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
687603|NCT01938066|P2|Participant Flow|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
687604|NCT01938066|P1|Participant Flow|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
687605|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
687606|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
687607|NCT01938066|O2|Outcome|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
687608|NCT01938066|O1|Outcome|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
687609|NCT01938066|E2|Reported Event|Negative Pressure Therapy Only|"Arm 1 is Negative Pressure Therapy only with no Procellera Dressing and the dressing is changed every other day per standard of care when you use Negative Pressure Therapy with no dressing underneath the sponge.~negative pressure therapy"
687610|NCT01938066|E1|Reported Event|Negative Pressure With Procellera|"Arm 2 is Negative Pressure Therapy and Procellera Dressing under the sponge dressing of the Negative Pressure Therapy. The dressing will be changed at the end of 5 days. This is the intervention arm of the study.~Procellera: bioelectric wound dressing~negative pressure therapy"
687611|NCT01938040|B3|Baseline|Total|Total of all reporting groups
687612|NCT01938040|B2|Baseline|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687613|NCT01938040|B1|Baseline|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687614|NCT01938040|P2|Participant Flow|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
688040|NCT01937130|P2|Participant Flow|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
687622|NCT01938040|O2|Outcome|Sugar Water|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687623|NCT01938040|O1|Outcome|Ibuprofen|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687624|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687625|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687626|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687627|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687628|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687629|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687630|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687631|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687632|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687633|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687634|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687635|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687636|NCT01938040|O2|Outcome|Placebo|"100mL of normal saline to be administered over 5 minutes~sugar water/placebo: single preoperative dose prior to surgery"
687637|NCT01938040|O1|Outcome|Ibuprofen/Caldolor|"800mg administered IV in 100cc of normal saline over 5 minutes~ibuprofen: single preoperative dose prior to surgery"
687638|NCT01938040|E2|Reported Event|Placebo|100mL of normal saline to be administered intravenously over 5 minutes prior to surgical incision.
687639|NCT01938040|E1|Reported Event|Caldolor/Ibuprofen|800mg administered IV in 100mL normal saline over 5 minutes prior to surgical incision.
687640|NCT01937975|B4|Baseline|Total|Total of all reporting groups
687641|NCT01937975|B3|Baseline|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687642|NCT01937975|B2|Baseline|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687643|NCT01937975|B1|Baseline|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687644|NCT01937975|P3|Participant Flow|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687645|NCT01937975|P2|Participant Flow|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687646|NCT01937975|P1|Participant Flow|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687647|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
687648|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687649|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687650|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687651|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687652|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687653|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. One participant was excluded due to an ill-defined terminal phase.
687654|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687708|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687655|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687656|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687657|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687658|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687659|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687660|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687661|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687662|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687663|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687664|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687665|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687666|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687667|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687668|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
687669|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687670|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687671|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687672|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687673|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687674|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days
687675|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687676|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease: HD Day 10|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687677|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687678|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687996|NCT01937312|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687679|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687680|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687681|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687682|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687683|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687684|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687685|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687686|NCT01937975|O3|Outcome|Healthy Participants: Day 10|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687687|NCT01937975|O2|Outcome|Participants With Severe Renal Impairment: Day 10|Participants with Severe Renal Impairment (SRI, estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687688|NCT01937975|O1|Outcome|Participants With End Stage Renal Disease|Participants with End Stage Renal Disease (ESRD) on hemodialysis (HD) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days. Day 9 was a non-hemodialysis day for these participants. On Day 10, hemodialysis for these participants was timed to occur after the median Tmax (~5 hours postdose).
687689|NCT01937975|E3|Reported Event|Healthy Participants|Healthy participants (estimated glomerular filtration rate >=80 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687690|NCT01937975|E2|Reported Event|Participants With Severe Renal Impairment|Participants with Severe Renal Impairment (estimated glomerular filtration rate <30 mL/min/1.73 m^2) received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687691|NCT01937975|E1|Reported Event|Participants With End Stage Renal Disease on Hemodialysis|Participants with End Stage Renal Disease on hemodialysis received once daily Grazoprevir 100 mg tablet and Elbasvir 50 mg tablet for 10 days.
687692|NCT01937871|B4|Baseline|Total|Total of all reporting groups
687693|NCT01937871|B3|Baseline|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687694|NCT01937871|B2|Baseline|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687695|NCT01937871|B1|Baseline|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687696|NCT01937871|P3|Participant Flow|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
687697|NCT01937871|P2|Participant Flow|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687698|NCT01937871|P1|Participant Flow|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687699|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687700|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687701|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687702|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687703|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
687704|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687705|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687706|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
687707|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687709|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687710|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687711|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687712|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687713|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687714|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687715|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687716|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687717|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
687718|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687719|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687720|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687721|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687722|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687723|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period. Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period.
687724|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687725|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687726|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687727|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687728|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687729|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687730|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687731|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687732|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687733|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687734|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687735|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687736|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687737|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687738|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687739|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687740|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
688041|NCT01937130|P1|Participant Flow|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
687741|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687742|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687743|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687744|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687745|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
687746|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687747|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687748|NCT01937871|O2|Outcome|5 mg Tadalafil|Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period.
687749|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687750|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687751|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687752|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687753|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687754|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687755|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687756|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687757|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687758|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687759|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687760|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687761|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687762|NCT01937871|O3|Outcome|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687763|NCT01937871|O2|Outcome|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687764|NCT01937871|O1|Outcome|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687765|NCT01937871|E3|Reported Event|0.2 mg Tamsulosin|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tamsulosin 0.2 mg capsule administered once daily by mouth for 12 weeks during the double-blind treatment period."
687766|NCT01937871|E2|Reported Event|5 mg Tadalafil|"Placebo administered once daily by mouth for 4 weeks during the single-blind placebo run-in period.~Tadalafil 5 milligram (mg) tablet administered once daily by mouth for 12 weeks during the double-blind treatment period."
687767|NCT01937871|E1|Reported Event|Placebo|Placebo matching tadalafil or tamsulosin administered once daily by mouth for 16 weeks.
687768|NCT01937715|B6|Baseline|Total|Total of all reporting groups
687769|NCT01937715|B5|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687770|NCT01937715|B4|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687771|NCT01937715|B3|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
688042|NCT01937130|O4|Outcome|Placebo|"Dosed twice daily~Placebo"
687772|NCT01937715|B2|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687773|NCT01937715|B1|Baseline|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687774|NCT01937715|P5|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687775|NCT01937715|P4|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687776|NCT01937715|P3|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687777|NCT01937715|P2|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687778|NCT01937715|P1|Participant Flow|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687779|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687780|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687781|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687782|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687783|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687784|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687785|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687786|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687787|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687788|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687789|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687790|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687791|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687792|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687793|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687997|NCT01937312|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687794|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687795|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687796|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687797|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687798|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687799|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687800|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687801|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687802|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687803|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687804|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687805|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687806|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687807|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687808|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687809|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687810|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687811|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687812|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687813|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687814|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687815|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687944|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687816|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687817|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687818|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687819|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687820|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687821|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687822|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687823|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687824|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687825|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687826|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687827|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687828|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687829|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687830|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687831|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687832|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687833|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687834|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687835|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687836|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687837|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687945|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
687838|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687839|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687840|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687841|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687842|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687843|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687844|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687845|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687846|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687847|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687848|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687849|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687850|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687851|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687852|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687853|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687854|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687855|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687856|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687857|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687858|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687859|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687946|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687860|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687861|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687862|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687863|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687864|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687865|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687866|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687867|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687868|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687869|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687870|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687871|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687872|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687873|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687874|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687875|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687876|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687877|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687878|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687879|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687880|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687881|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687947|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687998|NCT01937312|E1|Reported Event|Pre-Treatment|Prostaglandin analogue, 1 drop in each eye at bedtime for a 4-week run-in period
687882|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687883|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687884|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687885|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687886|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687887|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687888|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687889|NCT01937715|O5|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687890|NCT01937715|O4|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687891|NCT01937715|O3|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687892|NCT01937715|O2|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687893|NCT01937715|O1|Outcome|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687894|NCT01937715|E5|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 4|Participants received intravenous (IV) infusion of PF-05212384 150 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687895|NCT01937715|E4|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 3|Participants received intravenous (IV) infusion of PF-05212384 130 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687896|NCT01937715|E3|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2B|Participants received intravenous (IV) infusion of PF-05212384 110 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687897|NCT01937715|E2|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 2A|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 180 mg/m^2, leucovorin 400 mg/m^2, 5- fluorouracil (FU) 2400 mg/m^2, and IV bolus of 5-FU 400 mg/m^2 on Days 1 and 15 of each cycle.
687898|NCT01937715|E1|Reported Event|PF-05212384+5-FU+Irinotecan+Leucovorin:Dose Level 1|Participants received intravenous (IV) infusion of PF-05212384 90 mg weekly and IV infusions of irinotecan 150 mg/m^2, leucovorin 320 mg/m^2, 5- fluorouracil (FU) 1920 mg/m^2, and IV bolus of 5-FU 320 mg/m^2 on Days 1 and 15 of each cycle.
687899|NCT01937598|B1|Baseline|All Study Participants|All study participants (cross-over design) received all interventions.
687900|NCT01937598|P2|Participant Flow|Placebo, Than Sitagliptin|Participants first received Placebo tablet before mixed meal test, after washout they then received Sitagliptin before the mixed meal test.
687901|NCT01937598|P1|Participant Flow|Sitagliptin, Then Placebo|Participants first received Sitagliptin tablet before mixed meal test, after washout they then received Placebo before the mixed meal test.
687902|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687948|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687949|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687903|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687904|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687905|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687906|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687907|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687908|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687909|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687910|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687950|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687951|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687952|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687911|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687912|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687913|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687914|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687915|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687916|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687917|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687918|NCT01937598|O2|Outcome|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687953|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
687954|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687955|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
687919|NCT01937598|O1|Outcome|Sitagliptin|"Substance: Sitagliptin phosphate H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF(case report form). The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687920|NCT01937598|E2|Reported Event|Placebo|"Substance: Placebo (sitagliptin) Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH Doses: - Route of administration: p.o. as tablets~Placebo~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687921|NCT01937598|E1|Reported Event|Sitagliptin|"Substance: Sitagliptin phosphate 1H2O Pharmaceutical form: tablets Source: MSD SHARP & DOHME GMBH, Doses: 100 mg, Route of administration: p.o. as a tablet~Sitagliptin~Mixed meal test: Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored~Liraglutide: Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study."
687922|NCT01937520|B3|Baseline|Total|Total of all reporting groups
687923|NCT01937520|B2|Baseline|Sham/Placebo|"no acupuncture will be done on this group of subjects. Since they are under general anesthesia they will not realize they are acting as control group~no acupuncture: placebo"
687924|NCT01937520|B1|Baseline|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687925|NCT01937520|P2|Participant Flow|Sham|"no acupuncture will be done on this group of subjects but since they will be under general anesthesia they will not be aware that they are the control group~no acupuncture: placebo"
687926|NCT01937520|P1|Participant Flow|Acupuncture|"acupuncture will be administered after anesthesia induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687927|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687928|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687929|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687930|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687931|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687932|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687933|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687934|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687935|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687936|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687937|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687938|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687939|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
687940|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687941|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687942|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687943|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687999|NCT01937299|B3|Baseline|Total|Total of all reporting groups
687956|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687957|NCT01937520|O2|Outcome|Sham/Placebo|"no acupuncture will be done on this group of subjects. These subjects will be under general anesthesia and will not be aware that they are in control group.~no acupuncture: placebo"
687958|NCT01937520|O1|Outcome|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687959|NCT01937520|E2|Reported Event|Sham/Placebo|"no acupuncture will be done on this group of subjects~no acupuncture: placebo"
687960|NCT01937520|E1|Reported Event|Acupuncture|"acupuncture will be administered after induction for a period of 30 minutes, followed by a 30 minute rest period and then resumption of acupuncture for 30 minutes.~acupuncture: One half of subjects will receive a standardized acupuncture regiment"
687961|NCT01937364|B3|Baseline|Total|Total of all reporting groups
687962|NCT01937364|B2|Baseline|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours
687963|NCT01937364|B1|Baseline|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours
687964|NCT01937364|P2|Participant Flow|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
687965|NCT01937364|P1|Participant Flow|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
687966|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
687967|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
687968|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
687969|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
687970|NCT01937364|O2|Outcome|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
687971|NCT01937364|O1|Outcome|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
687972|NCT01937364|E2|Reported Event|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
687973|NCT01937364|E1|Reported Event|Placebo|Placebo every eight hours as inpatients for 72 hours or until discharge if less than 72 hours.
687974|NCT01937351|B3|Baseline|Total|Total of all reporting groups
687975|NCT01937351|B2|Baseline|Roll-In Cohort|The Roll-In Cohort consists of either the 1st subject or 1st and 2nd subjects treated at each site prior to enrollment of subjects into the Primary Cohort. Roll-Ins were designed to provide the Investigator an opportunity to gain experience with the Pantheris System (Catheter and Optical Coherence Tomography-assisted orientation) for learning curve purposes. Certain sites were exempt from enrolling in the Roll-In Cohort.
687976|NCT01937351|B1|Baseline|Primary Cohort|"The Primary Cohort consisted of either the 1st subject enrolled after the Roll-In cohort or the 1st subject enrolled if the site did not utilize Roll-In subjects.~The Primary Cohort was analyzed as two separate sub-cohorts: Intention to Treat and Per Protocol. The Intention to Treat Cohort includes all subjects that were enrolled. The Per Protocol Cohort includes subjects who were enrolled, and had the Pantheris Catheter or Occlusion Sheath device inserted into the vasculature. To be included in this cohort, the Pantheris Catheter also had to be successfully advanced to the intended target lesion. This cohort is a subset of subjects enrolled into the Intention to Treat Cohort.~The Primary Per Protocol Cohort was the cohort used to determine if the primary endpoints of the VISION Study were met."
687977|NCT01937351|P2|Participant Flow|Roll-in Group|Atherectomy with Pantheris System
687978|NCT01937351|P1|Participant Flow|Primary Cohort|Atherectomy with Pantheris System
687979|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
687980|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
687981|NCT01937351|O1|Outcome|Per Protocol Cohort|Atherectomy with Pantheris System
687982|NCT01937351|E1|Reported Event|Primary Cohort|Pantheris System
687983|NCT01937312|B3|Baseline|Total|Total of all reporting groups
687984|NCT01937312|B2|Baseline|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687985|NCT01937312|B1|Baseline|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687986|NCT01937312|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687987|NCT01937312|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687988|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687989|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687990|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687991|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687992|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687993|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687994|NCT01937312|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
687995|NCT01937312|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with prostaglandin analogue, 1 drop in each eye at bedtime, for 6 weeks
688000|NCT01937299|B2|Baseline|Vehicle|1 drop instilled 3 times a day in each eye for 6 weeks in conjunction with travoprost ophthalmic solution 0.004%
688001|NCT01937299|B1|Baseline|SIMBRINZA|1 drop instilled 3 times a day in each eye for 6 weeks as adjunctive therapy to travoprost ophthalmic solution 0.004%
688002|NCT01937299|P2|Participant Flow|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688003|NCT01937299|P1|Participant Flow|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688004|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688005|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688006|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688007|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688008|NCT01937299|O2|Outcome|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688009|NCT01937299|O1|Outcome|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime, for 6 weeks
688010|NCT01937299|E3|Reported Event|Vehicle|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
688011|NCT01937299|E2|Reported Event|SIMBRINZA|1 drop in each eye 3 times a day (8 AM, 3 PM, 10 PM), with travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 6-week treatment period
688012|NCT01937299|E1|Reported Event|Pre-Treatment|Travoprost 0.004% ophthalmic solution, 1 drop in each eye at bedtime for a 4-week run-in period
688013|NCT01937260|B3|Baseline|Total|Total of all reporting groups
688014|NCT01937260|B2|Baseline|Cohort 2|Brodalumab 140mg SC (Day1)
688015|NCT01937260|B1|Baseline|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
688016|NCT01937260|P2|Participant Flow|Cohort 2|Brodalumab 140 mg SC (Day 1)
688017|NCT01937260|P1|Participant Flow|Cohort 1|Midazolam (MDZ) 2mg Oral (Day 1 and Day 9) Brodalumab 210 mg SC (Day 2)
688018|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
688019|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9)Brodalumab 210mg SC (Day 2)
688020|NCT01937260|O1|Outcome|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
688021|NCT01937260|E2|Reported Event|Cohort 2|Brodalumab 140mg SC (Day1)
688022|NCT01937260|E1|Reported Event|Cohort 1|Midazolam (MDZ) 2mg oral (Day 1 and Day 9) Brodalumab 210mg SC (Day 2)
688023|NCT01937195|B1|Baseline|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688024|NCT01937195|P1|Participant Flow|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688025|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688026|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688027|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688028|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688029|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688030|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688031|NCT01937195|O1|Outcome|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688032|NCT01937195|E1|Reported Event|AccuCath Intravenous Catheter Device|AccuCath Intravenous Catheter System: AccuCath IV Catheter System (study device) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
688033|NCT01937130|B5|Baseline|Total|Total of all reporting groups
688034|NCT01937130|B4|Baseline|Placebo|"Dosed twice daily~Placebo"
688035|NCT01937130|B3|Baseline|IDN-6556 50 mg|"Dosed twice daily~IDN-6556"
688065|NCT01937130|E2|Reported Event|IDN-6556 25 mg|"Dosed twice daily~IDN-6556"
688066|NCT01937130|E1|Reported Event|IDN-6556 5 mg|"Dosed twice daily~IDN-6556"
688067|NCT01937026|B1|Baseline|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
688068|NCT01937026|P1|Participant Flow|Baricitinib|"4 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, twice daily (BID), on Days 3 through 7 in Period 2."
688069|NCT01937026|O2|Outcome|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
688070|NCT01937026|O1|Outcome|Baricitinib|4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
688071|NCT01937026|O2|Outcome|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 3 through 7 in Period 2."
688072|NCT01937026|O1|Outcome|Baricitinib|4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
688073|NCT01937026|E3|Reported Event|Baricitinib + Probenecid|"4 mg baricitinib tablet administered orally, once, on Day 5 in Period 2.~1000 mg probenecid tablet administered orally, BID, on Days 5 through 7 in Period 2.~Adverse events are reported from postdose on Day 5 up to Day 18."
688074|NCT01937026|E2|Reported Event|Probenecid|"1000 mg probenecid tablet administered orally, BID, on Days 3 through 4 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 5."
688075|NCT01937026|E1|Reported Event|Baricitinib|"4 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.~Adverse events are reported from baseline through predose on Day 3."
688076|NCT01936896|B1|Baseline|Alpha-1 Anti-trypsin (AAT)|Plasma derived (Alpha 1-Antitrypsin) AAT 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
688077|NCT01936896|P1|Participant Flow|Alpha-1 Anti-trypsin (AAT)|Plasma derived Alpha 1-Antitrypsin (AAT) 60 mg/Kg, single infusion, within 12 hours of hospital admission for ST-segment elevation myocardial infarction (STEMI)
688078|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
688079|NCT01936896|O1|Outcome|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
688080|NCT01936896|E1|Reported Event|Alpha-1 Anti-trypsin (AAT)|Plasma derived AAT 60 mg/Kg, single infusion
688081|NCT01936870|B1|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688082|NCT01936870|P1|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688083|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688084|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688085|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688086|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688087|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688088|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688089|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688090|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688091|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688092|NCT01936870|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688093|NCT01936870|E1|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate at an oral dose of 4 mg once daily. The dose was increased up to 8 mg once daily according to symptoms.
688094|NCT01936844|B3|Baseline|Total|Total of all reporting groups
688095|NCT01936844|B2|Baseline|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
688096|NCT01936844|B1|Baseline|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
688097|NCT01936844|P2|Participant Flow|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
688098|NCT01936844|P1|Participant Flow|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
688099|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
688240|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688281|NCT01934582|E1|Reported Event|PK Visit 1|UT-15C SR (treprostinil diethanolamine): open-label study drug
688100|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
688101|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
688102|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
688103|NCT01936844|O2|Outcome|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
688104|NCT01936844|O1|Outcome|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
688105|NCT01936844|E2|Reported Event|Placebo|"Placebo injections twice daily for the first 3 days then once daily for days 4-14.~Placebo: Placebo twice daily for days 1, 2, and 3~Placebo: Placebo daily for days 4-14"
688106|NCT01936844|E1|Reported Event|Anakinra (Short)|"Anakinra 100 mg twice daily for the first 3 days followed by 100 mg daily for days 4-14~Anakinra (high dose): Anakinra 100 mg daily twice daily for days 1, 2, and 3~Anakinra (standard dose): Anakinra 100 mg daily for days 4-14"
688107|NCT01936662|B3|Baseline|Total|Total of all reporting groups
688108|NCT01936662|B2|Baseline|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
688109|NCT01936662|B1|Baseline|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
688110|NCT01936662|P2|Participant Flow|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
688111|NCT01936662|P1|Participant Flow|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
688112|NCT01936662|O2|Outcome|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
688113|NCT01936662|O1|Outcome|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
688114|NCT01936662|O2|Outcome|Endotracheal Tube for EGD Procedure|"Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital~ETT: Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital"
688115|NCT01936662|O1|Outcome|Largyngeal Mask Airway for EGD Procedure|"Patients randomized to LMA to maintain airway through EGD procedure~LMA: Patients randomized to the LMA group had their airways maintained with a LMA device"
688116|NCT01936662|E2|Reported Event|ETT Used to Maintain Airway|Patients were randomized to ETT to maintain airway for EGD procedure. This is the standard of care at this hospital
688117|NCT01936662|E1|Reported Event|LMA Used to Maintain Airway|Patients randomized to LMA to maintain airway through EGD procedure
688118|NCT01936649|B1|Baseline|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
688119|NCT01936649|P1|Participant Flow|AdreView (Iobenguane I 123 Injection)|Two administrations of single intravenous (i.v.) injection of Iobenguane I 123 10 millicuries (mCi) (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
688120|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
688121|NCT01936649|O1|Outcome|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
688122|NCT01936649|E1|Reported Event|AdreView (Iobenguane I 123 Injection)|Two administrations of single i.v. injection of Iobenguane I 123 10 mCi (370 MBq) over 1 to 2 minutes within an interval of 5 to 14 days.
688123|NCT01936467|B3|Baseline|Total|Total of all reporting groups
688124|NCT01936467|B2|Baseline|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688125|NCT01936467|B1|Baseline|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688126|NCT01936467|P2|Participant Flow|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688127|NCT01936467|P1|Participant Flow|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688128|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688129|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688130|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688131|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688132|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688133|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688134|NCT01936467|O2|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688135|NCT01936467|O1|Outcome|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688136|NCT01936467|O2|Outcome|Patients With Negative Gold Standard|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688137|NCT01936467|O1|Outcome|Patients With Positive Gold Standard|gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.
688138|NCT01936467|O2|Outcome|Patients With Negative Gold Standard|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688139|NCT01936467|O1|Outcome|Patients With Positive Gold Standard|gold standard is defined as follows: for resectable cases, surgical histology was considered the gold standard. For unresectable or benign cases, positive cytology (with compatible clinical outcome) at 6-month follow-up was considered gold standard. Negative cytology was confirmed with clinical data and/or imaging at 6 month follow-up.
688140|NCT01936467|O1|Outcome|Standard Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688241|NCT01934894|O2|Outcome|Dose Level 2|Cabazitaxel 25mg/m^2:: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688466|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
688141|NCT01936467|O1|Outcome|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688142|NCT01936467|E2|Reported Event|Capillary Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the capillary suction FNA technique: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.~Capillary suction technique for EUS FNA: Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously"
688143|NCT01936467|E1|Reported Event|Suction Technique|"These are patients who will have endoscopic ultrasound-guided fine needle aspiration using the standard suction FNA technique: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.~Standard technique EUS-FNA: Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe."
688144|NCT01936389|B3|Baseline|Total|Total of all reporting groups
688145|NCT01936389|B2|Baseline|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
688146|NCT01936389|B1|Baseline|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
688147|NCT01936389|P2|Participant Flow|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
688148|NCT01936389|P1|Participant Flow|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
688149|NCT01936389|O2|Outcome|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
688150|NCT01936389|O1|Outcome|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
688151|NCT01936389|E2|Reported Event|0.7%|"0.7% Rho-Kinase Inhibitor~AR-12286"
688152|NCT01936389|E1|Reported Event|0.5%|"0.5% Rho-Kinase Inhibitor~AR-12286"
688153|NCT01936363|B3|Baseline|Total|Total of all reporting groups
688154|NCT01936363|B2|Baseline|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688155|NCT01936363|B1|Baseline|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688156|NCT01936363|P2|Participant Flow|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688157|NCT01936363|P1|Participant Flow|Pimasertib (Once Daily) Plus SAR245409|Subjects received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688158|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688159|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688160|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688161|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688162|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688163|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received Pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688164|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688165|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688166|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
729364|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
688167|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688168|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688169|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688170|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688171|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688172|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688173|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688174|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688175|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688176|NCT01936363|O2|Outcome|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688177|NCT01936363|O1|Outcome|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688178|NCT01936363|E2|Reported Event|Pimasertib (Twice Daily) Plus SAR245409 Placebo|Subjects received pimasertib oral capsule at a dose of 60 mg twice daily along with placebo matching to SAR245409 once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688179|NCT01936363|E1|Reported Event|Pimasertib (Once Daily) Plus SAR245409|Subjects received pimasertib oral capsule at a dose of 60 milligram (mg) once daily along with SAR245409 oral capsule at a dose of 70 mg once daily and placebo matching to pimasertib in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever comes first.
688180|NCT01936181|B3|Baseline|Total|Total of all reporting groups
688181|NCT01936181|B2|Baseline|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
688182|NCT01936181|B1|Baseline|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
688183|NCT01936181|P4|Participant Flow|Remicade (Infliximab), Continue as Remicade|"Remicade 3mg/kg at week 54, 62, 70~Remicade (infliximab)"
688184|NCT01936181|P3|Participant Flow|Remicade (Infliximab), Switch to SB2|"SB2 3mg/kg at week 54, 62, 70~SB2 (proposed biosimilar to infliximab)"
688185|NCT01936181|P2|Participant Flow|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
688186|NCT01936181|P1|Participant Flow|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
688187|NCT01936181|O5|Outcome|Remicade (Infliximab), Continue as Remicade|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to continue on Remicade (Remicade/Remicade) up to Week 70 and received Remicade 3mg/kg at week 54, 62, 70."
688188|NCT01936181|O4|Outcome|Remicade (Infliximab), Switch to SB2 at Week 78|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised to be transitioned to SB2 (Remicade/SB2) up to Week 70 and received SB2 3mg/kg at week 54, 62, 70.~SB2 (proposed biosimilar to infliximab)"
688189|NCT01936181|O3|Outcome|SB2 at Week 78|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
688190|NCT01936181|O2|Outcome|Remicade (Infliximab) at Week 54|Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
688191|NCT01936181|O1|Outcome|SB2 at Week 54|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
691984|NCT01911689|O1|Outcome|Mild AP|Mild AP was defined as 0-3 points according to MRSI.
688192|NCT01936181|O2|Outcome|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
688193|NCT01936181|O1|Outcome|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
688194|NCT01936181|E2|Reported Event|Remicade (Infliximab)|"Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46~At Week 54, subjects were randomised again in a 1:1 ratio to either continue on Remicade (Remicade/Remicade) or be transitioned to SB2 (Remicade/SB2) up to Week 70."
688195|NCT01936181|E1|Reported Event|SB2 (Proposed Biosimilar to Inflixmab)|"SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70~SB2 (proposed biosimilar to infliximab)"
688196|NCT01935622|B4|Baseline|Total|Total of all reporting groups
688197|NCT01935622|B3|Baseline|Placebo|"Placebo~placebo"
688198|NCT01935622|B2|Baseline|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
688199|NCT01935622|B1|Baseline|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
688200|NCT01935622|P3|Participant Flow|Placebo|"Placebo~placebo"
688201|NCT01935622|P2|Participant Flow|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
688202|NCT01935622|P1|Participant Flow|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
688203|NCT01935622|O3|Outcome|Placebo|"Placebo~placebo"
688204|NCT01935622|O2|Outcome|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
688205|NCT01935622|O1|Outcome|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
688206|NCT01935622|E3|Reported Event|Placebo|"Placebo~placebo"
688207|NCT01935622|E2|Reported Event|Doxycycline 20 mg|"Doxycycline 20 mg twice daily for 14 days~Doxycycline"
688208|NCT01935622|E1|Reported Event|Doxycycline 100 mg|"Doxycycline 100 mg twice daily for 14 days~Doxycycline"
688209|NCT01935180|B3|Baseline|Total|Total of all reporting groups
688210|NCT01935180|B2|Baseline|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.~Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
688211|NCT01935180|B1|Baseline|Standard Colonoscopy|Standard colonoscopy without an attachment cap
688212|NCT01935180|P2|Participant Flow|Cap Assisted Colonoscopy|"A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.~Colonoscopy Cap: 4mm transparent cap (Olympus) mounted to the tip of a colonoscope."
688213|NCT01935180|P1|Participant Flow|Standard Colonoscopy|Standard colonoscopy without an attachment cap
688214|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688215|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
688216|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688217|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
688218|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688219|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
688220|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688221|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
688222|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688223|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
688224|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688225|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
688226|NCT01935180|O2|Outcome|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688227|NCT01935180|O1|Outcome|Standard Colonoscopy|Colonoscopy without a cap.
688228|NCT01935180|E2|Reported Event|Cap Assisted Colonoscopy|A transparent cap will be affixed to tip of the high-definition wide angle colonoscope.
688229|NCT01935180|E1|Reported Event|Standard Colonoscopy|Colonoscopy without a cap.
688230|NCT01934894|B3|Baseline|Total|Total of all reporting groups
688231|NCT01934894|B2|Baseline|Dose Level 2 (Level 1 (25 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688232|NCT01934894|B1|Baseline|Dose Level 1 (20 mg/m2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688233|NCT01934894|P2|Participant Flow|Dose Level 2 (Level 1 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688234|NCT01934894|P1|Participant Flow|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688235|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688236|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688237|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688238|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688239|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
691985|NCT01911689|O2|Outcome|Necrotizing AP|T2* value of necrotizing AP
688242|NCT01934894|O1|Outcome|Dose Level 1|Cabazitaxel: 20 mg/m^2: 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688243|NCT01934894|O1|Outcome|Cabazitaxel and Lapatinib|Cabazitaxel: (at Dose Level 1, 20 mg/m^2 or at Dose Level 2, 25 mg/m^2), 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688244|NCT01934894|O2|Outcome|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688245|NCT01934894|O1|Outcome|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688246|NCT01934894|E2|Reported Event|Dose Level 2 (25 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 25 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688247|NCT01934894|E1|Reported Event|Dose Level 1 (20 mg/m^2 Cabazitaxel + Lapatinib)|Cabazitaxel: 20 mg/m^2, 1-hour IV infusion on Day 1 of each 3 week cycle, Lapatinib: 1000 mg by mouth (PO) once daily
688248|NCT01934790|B1|Baseline|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688249|NCT01934790|P1|Participant Flow|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688250|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688251|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688252|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688253|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688254|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688255|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688256|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688257|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688258|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688259|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688260|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688261|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688262|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688263|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688264|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688265|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688266|NCT01934790|O1|Outcome|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688267|NCT01934790|E1|Reported Event|Radium-223 Dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
688268|NCT01934582|B1|Baseline|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria, who had sufficient treprostinil concentration-time data to derive noncompartmental PK parameters for at least 1 treatment of open-label treprostinil diethanolamine.
688269|NCT01934582|P1|Participant Flow|Open-label Extension PK Population|The PK population included all subjects enrolled in the PK substudy having met the study criteria who received at least 1 treatment of open-label treprostinil diethanolamine.
688270|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
688271|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
688272|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
688273|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
688274|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
688275|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
688276|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
688277|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
688278|NCT01934582|O2|Outcome|PK Visit 2|UT-15C SR (treprostinil diethanolamine) TID
688279|NCT01934582|O1|Outcome|PK Visit 1|UT-15C SR (treprostinil diethanolamine) BID
688280|NCT01934582|E2|Reported Event|PK Visit 2|UT-15C SR (treprostinil diethanolamine): open-label study drug
691986|NCT01911689|O1|Outcome|Edematous AP|T2* value of edematous AP
688282|NCT01934517|B1|Baseline|iTero, Lava Digital and Plaster Models|All study participants: iTero, LavaDigital and plaster models (single-group study)
688283|NCT01934517|P1|Participant Flow|iTero, Lava Digital and Plaster Models: All Study Participants|"Single-group study:~ITero models obtained from intraoral scans with iTero scanner~Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster~Lava Digital models obtained from extraoral scans of plaster models"
688284|NCT01934517|O3|Outcome|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
688285|NCT01934517|O2|Outcome|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
688286|NCT01934517|O1|Outcome|iTero Models|ITero models obtained from intraoral scans with iTero scanner
688287|NCT01934517|E3|Reported Event|Lava Digital Models|Lava Digital models obtained from extraoral scans of plaster models
688288|NCT01934517|E2|Reported Event|Plaster Models|Plaster models obtained from alginate and PVS intraoral impressionsScan of plaster
688289|NCT01934517|E1|Reported Event|iTero Models|ITero models obtained from intraoral scans with iTero scanner
688290|NCT01934504|B5|Baseline|Total|Total of all reporting groups
688291|NCT01934504|B4|Baseline|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
688292|NCT01934504|B3|Baseline|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688293|NCT01934504|B2|Baseline|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688294|NCT01934504|B1|Baseline|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688295|NCT01934504|P4|Participant Flow|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
688296|NCT01934504|P3|Participant Flow|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688297|NCT01934504|P2|Participant Flow|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688298|NCT01934504|P1|Participant Flow|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688299|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
688300|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688301|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688302|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688303|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
689294|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
688304|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688305|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688306|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688307|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
688308|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688309|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688310|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688311|NCT01934504|O4|Outcome|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
688312|NCT01934504|O3|Outcome|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688313|NCT01934504|O2|Outcome|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688314|NCT01934504|O1|Outcome|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688315|NCT01934504|E4|Reported Event|AAV Discontinuing Immunosuppression|Subjects in the ANCA-associated vasculitis (AAV) Discontinuing Immunosuppression group have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis BVAS/WG) scores of zero and on minimal maintenance therapy for at least 2 years prior to screening. The subjects’ primary physicians have planned to discontinue immunosuppression medication in the next year after screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and at 8 weeks after discontinuation of immunosuppression medication.
688316|NCT01934504|E3|Reported Event|Healthy Controls|Healthy participants without autoimmune disease. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688317|NCT01934504|E2|Reported Event|Non-Tolerant AAV|Subjects in the Non-Tolerant ANCA-associated vasculitis (AAV) cohort have had a disease exacerbation and re-institution of immunosuppressive therapy in the past 5 years. Subjects have also been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and on minimal maintenance therapy for at least 3 months prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688318|NCT01934504|E1|Reported Event|Tolerant AAV|Subjects in the Tolerant ANCA-associated vasculitis (AAV) cohort have been in clinical remission with Birmingham Vasculitis Activity Score for Wegener’s Granulomatosis (BVAS/WG) scores of zero and have been off all immunosuppression medications for at least 2 years prior to screening. Subjects have blood samples and other assessments collected for analysis at Week 0 and Week 26.
688319|NCT01934231|B1|Baseline|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688320|NCT01934231|P1|Participant Flow|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688467|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
688321|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688322|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688323|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688324|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688325|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688326|NCT01934231|O1|Outcome|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688327|NCT01934231|E1|Reported Event|CVA/AMPC (1:14)|Participants received an oral dose of dry syrup potassium clavulanate (CVA)/amoxicillin hydrate (APMC) for 7 days. The daily dose of CVA/AMPC (1:14) was equal to CVA 6.4 milligrams (mg) (potency)/kilogram (kg)/day and AMPC 90 mg (potency)/kg/day in two divided doses (every 12 hours) just before lactation or meal depending on body weight at the start of treatment (Day 1).
688328|NCT01933880|B3|Baseline|Total|Total of all reporting groups
688329|NCT01933880|B2|Baseline|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688330|NCT01933880|B1|Baseline|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688331|NCT01933880|P2|Participant Flow|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688332|NCT01933880|P1|Participant Flow|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688333|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688334|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688335|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
688336|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d).
688337|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
688338|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d).
688339|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
688340|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
688341|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
688342|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
688343|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
688344|NCT01933880|O3|Outcome|OROS-MPH Group 54 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 56 milligram per day (mg/d)
688345|NCT01933880|O2|Outcome|OROS-MPH Group 36 mg|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 36 milligram per day (mg/d)
688346|NCT01933880|O1|Outcome|OROS-MPH Group 18 Milligram (mg)|Participants with ADHD received OROS -MPH tablets orally daily at a dose of 18 milligram per day (mg/d).
688347|NCT01933880|O2|Outcome|Normal|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688586|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688348|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688349|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688350|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688351|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688352|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688353|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688354|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688355|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688356|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688357|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688358|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688359|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688360|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688361|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688362|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688363|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688364|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688365|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688366|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688367|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688368|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688369|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
693102|NCT01904773|E5|Reported Event|Part 2 - AZD5213 2.0 mg|Part 2 - AZD5213, 2.0 mg periods (2 periods)
688370|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688371|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688372|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688373|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688374|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688375|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688376|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688377|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688378|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688379|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688380|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688381|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688382|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688383|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688384|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688385|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688386|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688387|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688388|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688389|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688390|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688391|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
693581|NCT01901341|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
688392|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688393|NCT01933880|O2|Outcome|Normal Group|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
688394|NCT01933880|O1|Outcome|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688395|NCT01933880|E1|Reported Event|OROS-MPH Group|Participants with attention deficit hyperactivity disorder (ADHD) received osmotic release oral system-methylphenidate (OROS-MPH) tablets orally daily, starting at initial dosage of 18 milligram per day (mg/d) which could be increased to 36 mg/d up to a maximum dosage of 54 mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18 mg due to intolerance.
688396|NCT01933776|B3|Baseline|Total|Total of all reporting groups
688397|NCT01933776|B2|Baseline|ADACEL™ Vaccine Group 2|Children 4 to 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688398|NCT01933776|B1|Baseline|ADACEL™ Vaccine Group 1|Adults 18 to 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688399|NCT01933776|P2|Participant Flow|ADACEL™ Vaccine Group 2 (Children)|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688400|NCT01933776|P1|Participant Flow|ADACEL™ Vaccine Group 1 (Adults)|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688401|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688402|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688403|NCT01933776|O2|Outcome|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688404|NCT01933776|O1|Outcome|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688405|NCT01933776|E2|Reported Event|ADACEL™ Vaccine Group 2|Children 4 through 8 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688406|NCT01933776|E1|Reported Event|ADACEL™ Vaccine Group 1|Adults 18 through 64 years of age received a single booster dose of Tdap vaccine (ADACEL™)
688407|NCT01933672|B1|Baseline|All*|A total of 90 participants with T2DM were consented for this study; of these, 43 transitioned into run-in with Sponsor-provided metformin and a total of 33 participants were randomized.
688408|NCT01933672|P7|Participant Flow|Sitagliptin Then PF-04937319 300mg Then PF-04937319 150+100mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the third intervention period.
688409|NCT01933672|P6|Participant Flow|Sitagliptin Then PF-04937319 150+100mg Then PF-04937319 300mg|Participants received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
688410|NCT01933672|P5|Participant Flow|PF-04937319 300mg Then Sitagliptin Then PF-04937319 150+100mg|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period.
688424|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688425|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688411|NCT01933672|P4|Participant Flow|PF-04937319 300mg Then PF-04937319 150+100mg Then Sitagliptin|Participants received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days.
688412|NCT01933672|P3|Participant Flow|PF-04937319 150+100mg Then Sitagliptin Then PF-04937319 300mg|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
688413|NCT01933672|P2|Participant Flow|PF-04937319 150+100mg Then PF-04937319 300mg Then Sitagliptin|Participants received the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day and the second dose (PF-04937319 100mg) was taken with the lunch meal 5±1 hours after the morning dose, each day, for 14±2 days in the first intervention period; and then received the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the second intervention period; and then received the morning dose of sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day, and the second dose of the study medication (placebo) was taken with the lunch meal 5±1 hours after the morning dose each day for 14±2 days in the third intervention period.
688414|NCT01933672|P1|Participant Flow|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 milligram (mg) immediate-release tablets.
688415|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688416|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688417|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688418|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688419|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688420|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688421|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688422|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688423|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688463|NCT01933425|O1|Outcome|Deep Neuromuscular Blockade|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
688426|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688427|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688428|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688429|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688430|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688431|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688432|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688433|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688434|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688435|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688436|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688437|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688438|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688439|NCT01933672|O4|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688440|NCT01933672|O3|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688441|NCT01933672|O2|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688442|NCT01933672|O1|Outcome|Metformin Run-in|Participants were instructed to take the morning dose of the study medication and at least 1 dose of open label metformin at the same time of day with the morning meal each day.
688443|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688464|NCT01933425|O2|Outcome|No Neuromuscular Block|Intraabdominal distance during no neuromuscular block
688444|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688445|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688446|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688447|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688448|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688449|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688450|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688451|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688452|NCT01933672|O3|Outcome|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688453|NCT01933672|O2|Outcome|PF-04937319 Once-Daily (300 mg)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688454|NCT01933672|O1|Outcome|PF-04937319 Split-Dose (150+100 mg)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688455|NCT01933672|E4|Reported Event|Sitagliptin 100 mg|Participants were instructed to take the morning dose of Sitagliptin 100 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication ()placebo should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688456|NCT01933672|E3|Reported Event|PF-04937319 300 mg (Once Daily)|Participants were instructed to take the morning dose of PF-04937319 300 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (placebo) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688457|NCT01933672|E2|Reported Event|PF-04937319 150+100 mg (Split Dose)|Participants were instructed to take the morning dose of PF-04937319 150 mg and at least 1 dose of open label metformin at the same time of day with the morning meal each day. In addition, the second dose of the study medication (PF-04937319 100 mg) should have been taken with the lunch meal approximately 5±1 hours after the morning dose, each day, for 14±2 days.
688458|NCT01933672|E1|Reported Event|Metformin Run-in|Sponsor-provided, open-label metformin was administered from the run-in visit to the follow-up visit, inclusive, and it was provided as 500 mg immediate-release tablets.
688459|NCT01933425|B1|Baseline|Patient Characteristics in 14 Women|
688460|NCT01933425|P2|Participant Flow|No Neuromuscular Block First Then Deep Neuromuscular Block|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
688461|NCT01933425|P1|Participant Flow|Deep Neuromuscular Block First Then no Neuromuscular Block|"Deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg followed by no neuromuscular blockade with sugammadex 8 mg/kg and placebo reversal.~Measurements of intraabdominal distance during deep neuromuscular blockade and without neuromuscular blockade~rocuronium~sugammadex~placebo"
688462|NCT01933425|O2|Outcome|no Neuromuscular Blockade|"No neuromuscular blockade with placebo followed by deep neuromuscular blockade (PTC 0-1) with rocuronium 1 mg/kg and reversal with sugammadex 8 mg/kg.~Measurements of intraabdominal distance during no neuromuscular blockade and during deep neuromuscular blockade.~rocuronium~sugammadex~placebo"
688465|NCT01933425|O1|Outcome|Deep Neuromuscular Block|Intraabdominal distance during deep neuromuscular blockade (PTC 0-1).
688468|NCT01933425|E2|Reported Event|No Neuromuscular Block First Then Deep Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
688469|NCT01933425|E1|Reported Event|Deep Neuromuscular Block First Then no Neuromuscular Block|Difference in intraabdominal distance comparing deep neuromuscular blockade (PTC 0-1) with no neuromuscular blockade.
688470|NCT01933399|B4|Baseline|Total|Total of all reporting groups
688471|NCT01933399|B3|Baseline|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
688472|NCT01933399|B2|Baseline|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
688473|NCT01933399|B1|Baseline|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
688474|NCT01933399|P3|Participant Flow|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
688475|NCT01933399|P2|Participant Flow|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
688476|NCT01933399|P1|Participant Flow|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
688477|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
688478|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
688479|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
688480|NCT01933399|O3|Outcome|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
688481|NCT01933399|O2|Outcome|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
688482|NCT01933399|O1|Outcome|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
688483|NCT01933399|E3|Reported Event|Inextensible Lumbosacral Orthoses and Standard of Care|"This group receives an inextensible lumbosacral orthoses which leads to 14% increase in trunk stiffness compared to the other conditions.~Inextensible LSO (stiff back support): Cotton/nylon canvas back support with velcro fasteners."
688484|NCT01933399|E2|Reported Event|Extensible Lumbosacral Orthoses Plus Standard of Care|"This group receives a flexible/extensible lumbosacral orthosis, one that is commonly available over the counter~Extensible LSO, a back support that is flexible: Back support is constructed from lycra and neoprene with velcro fasteners."
688485|NCT01933399|E1|Reported Event|Standard of Care|"Medication based on physician prescriptions or overcounter use not germane to the study. Subjects also receive physical therapy for 2 weeks.~Standard of Care: Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy."
688486|NCT01933334|B3|Baseline|Total|Total of all reporting groups
688487|NCT01933334|B2|Baseline|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
688488|NCT01933334|B1|Baseline|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
688489|NCT01933334|P2|Participant Flow|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
688490|NCT01933334|P1|Participant Flow|Pirfenidone: 2-Week Titration Group|Participants received one 267 milligrams (mg) oral pirfenidone capsule three times daily (TID) (801 mg per day [mg/day]) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
688491|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
729365|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
688492|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
688493|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
688494|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
688495|NCT01933334|O2|Outcome|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
688496|NCT01933334|O1|Outcome|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
688497|NCT01933334|E2|Reported Event|Pirfenidone: 4-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 2 weeks followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 2 weeks (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 12 weeks (maintenance period).
688498|NCT01933334|E1|Reported Event|Pirfenidone: 2-Week Titration Group|Participants received one 267 mg oral pirfenidone capsule TID (801 mg/day) for 1 week followed by two 267 mg oral pirfenidone capsules TID (1602 mg/day) for 1 week (titration period) and then three 267 mg oral pirfenidone capsules TID (2403 mg/day) for 14 weeks (maintenance period).
688499|NCT01933230|B1|Baseline|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~We will place an Excel Cryo Cooling System collar around your neck for two hours. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
688500|NCT01933230|P1|Participant Flow|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~Excel Cryo Cooling System: We will place an Excel Cryo Cooling System collar around your neck for two hours."
688501|NCT01933230|O1|Outcome|Excel Cryo Cooling System Collar|We will place an Excel Cryo Cooling System collar around your neck for a 2 hour neck cooling period. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).
688502|NCT01933230|E1|Reported Event|Excel Cryo Cooling System Collar|"We will place an Excel Cryo Cooling System collar around your neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool as well. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar that delivers the cold. The cooling pack is similar to, but not the same as, the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration of the study. During the study and for two hours after, we will collect data concerning the brain temperature (if applicable), body temperature, brain oxygen level (if applicable) and pressure both in the head (if applicable) and in the blood (blood pressure).~2 hour neck cooling period"
688503|NCT01932970|B1|Baseline|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688504|NCT01932970|P1|Participant Flow|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688505|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688506|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688507|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688508|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688509|NCT01932970|O1|Outcome|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688510|NCT01932970|E1|Reported Event|Etelcalcetide|Participants were treated with 5 mg etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session three times per week (TIW) for 4 weeks.
688511|NCT01932762|B5|Baseline|Total|Total of all reporting groups
688512|NCT01932762|B4|Baseline|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688513|NCT01932762|B3|Baseline|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688514|NCT01932762|B2|Baseline|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688515|NCT01932762|B1|Baseline|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688516|NCT01932762|P4|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688517|NCT01932762|P3|Participant Flow|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688518|NCT01932762|P2|Participant Flow|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688519|NCT01932762|P1|Participant Flow|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of ribavirin (RBV) for 12 weeks.
688520|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688521|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688522|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688523|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688524|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688525|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688526|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688527|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688528|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688529|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688530|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688531|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688532|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688533|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688534|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688535|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688536|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688537|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688538|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688539|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688540|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688541|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688542|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
694356|NCT01896050|O1|Outcome|Aromatase Inhibitor|Aromatase inhibitor-treated patients
688543|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688544|NCT01932762|O4|Outcome|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688545|NCT01932762|O3|Outcome|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688546|NCT01932762|O2|Outcome|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688547|NCT01932762|O1|Outcome|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688548|NCT01932762|E4|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir (Arm B3)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir for 12 weeks.
688549|NCT01932762|E3|Reported Event|GT 4,5,6: Grazoprevir + Elbasvir + RBV (Arm B2)|During Part B of the study, GT4/GT5/GT6 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688550|NCT01932762|E2|Reported Event|GT2: Grazoprevir + RBV (Arm B1)|During Part B of the study, GT2 participants received 100 mg grazoprevir plus standard weight-based dosing of RBV for 12 weeks.
688551|NCT01932762|E1|Reported Event|GT2: Grazoprevir + Elbasvir + RBV (Arm A1)|During Part A of the study, GT2 participants received 100 mg grazoprevir plus 50 mg elbasvir plus standard weight-based dosing of RBV for 12 weeks.
688552|NCT01932606|B3|Baseline|Total|Total of all reporting groups
688553|NCT01932606|B2|Baseline|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688554|NCT01932606|B1|Baseline|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688555|NCT01932606|P2|Participant Flow|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688556|NCT01932606|P1|Participant Flow|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688557|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688558|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688559|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688560|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688561|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688562|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688563|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688564|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688565|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688566|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688567|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688568|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688569|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688570|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688571|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688572|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688573|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688574|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688575|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688576|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688577|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688578|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688579|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688580|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688581|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688582|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688583|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688584|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688585|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688587|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688588|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688589|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688590|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688591|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688592|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688593|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688594|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688595|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688596|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688597|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688598|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688599|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688600|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688601|NCT01932606|O2|Outcome|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688602|NCT01932606|O1|Outcome|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688603|NCT01932606|E2|Reported Event|Placebo|Saline Placebo for Nitrite will be infused for 5 minutes during the cardiac catheterization procedure.
688604|NCT01932606|E1|Reported Event|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
688605|NCT01932164|B1|Baseline|Cleft Lip and Palate|"5 Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment will be selected to be submited to alveolar bone tissue engineering surgery~maxillary alveolar graft by tissue engineering: Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;~Bone tissue engineering using mesenchymal stem cells: Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
688606|NCT01932164|P1|Participant Flow|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
688607|NCT01932164|O1|Outcome|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
688608|NCT01932164|E1|Reported Event|Cleft Lip and Palate|"Patients with cleft unilateral lip and palate that have already performed the alignment of dental arches through the recommended orthodontic treatment~maxillary alveolar graft by tissue engineering: Extraction of deciduous tooth of cleft lip and palate patients to obtain mesenchymal stem cells; Secondary graft by bone tissue engineering using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite."
688609|NCT01932112|B1|Baseline|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
688610|NCT01932112|P1|Participant Flow|Adenosine Arm|"After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
688611|NCT01932112|O1|Outcome|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 12mg Iv adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
688612|NCT01932112|E1|Reported Event|Adenosine Arm|"After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.~Adenosine arm: After pulmonary vein isolation, 20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection."
688613|NCT01932060|B3|Baseline|Total|Total of all reporting groups
688614|NCT01932060|B2|Baseline|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688615|NCT01932060|B1|Baseline|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
729366|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
688616|NCT01932060|P2|Participant Flow|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688617|NCT01932060|P1|Participant Flow|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688618|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688619|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688620|NCT01932060|O2|Outcome|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688621|NCT01932060|O1|Outcome|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688622|NCT01932060|E2|Reported Event|Oxytocin Infusion 2|"Oxytocin infusion 2.5 U/hr to begin after the delivery of the fetus and to terminate at the time of discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688623|NCT01932060|E1|Reported Event|Oxytocin Infusion 1|"Oxytocin Infusion 15 U/hr to begin after the delivery of the fetus and to terminate at the time of patient discharge from the post-anesthesia care unit.~Oxytocin Infusion: Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit."
688624|NCT01931878|B1|Baseline|All Study Participants|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
688625|NCT01931878|P2|Participant Flow|IncobotulinumtoxinA First, Then Placebo|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo."
688626|NCT01931878|P1|Participant Flow|Placebo First, Then Incobotulinumtoxin A|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug.
688627|NCT01931878|O2|Outcome|IncobotulinumtoxinA Treatment|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
688628|NCT01931878|O1|Outcome|Placebo , Saline|Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design.
688629|NCT01931878|O2|Outcome|Xeomin|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions."
688630|NCT01931878|O1|Outcome|Placebo|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo."
688631|NCT01931878|O2|Outcome|Xeomin|incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin which is approved for use by the FDA for certain conditions. This study has a double blind cross over design.
688632|NCT01931878|O1|Outcome|Placebo|In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections.
688633|NCT01931878|E2|Reported Event|IncobotulinumtoxinA Treatment|"The subjects will be randomized to received injections of active study drug, incobotulinumtoxinA (Xeomin)~incobotulinumtoxinA: The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
688819|NCT01930487|P1|Participant Flow|Supplement With Antioxidants, Then Placebo|dietary supplement with antioxidants in the first intervention period, followed by placebo supplement in the second intervention period
688634|NCT01931878|E1|Reported Event|Placebo , Saline|"The subject may be randomly assigned to receive Placebo, saline~Placebo: The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections."
688635|NCT01931865|B1|Baseline|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
688636|NCT01931865|P1|Participant Flow|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
688637|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
688638|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The ttoal dose will not exceed 100 units.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
688639|NCT01931865|O1|Outcome|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
688640|NCT01931865|E1|Reported Event|IncobotulinumtoxinA|"The total dose will depend on the extent of the area involved by pain. The injections will be carried out through a 1cc syringe using a ½ to 1 inch needle intramuscularly or subcutaneously (or both). The number of injections will not exceed 5 sites.~IncobotulinumtoxinA: Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions."
688641|NCT01931839|B8|Baseline|Total|Total of all reporting groups
688642|NCT01931839|B7|Baseline|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
688643|NCT01931839|B6|Baseline|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
688644|NCT01931839|B5|Baseline|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
688645|NCT01931839|B4|Baseline|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
688646|NCT01931839|B3|Baseline|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
688647|NCT01931839|B2|Baseline|q12h Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
688648|NCT01931839|B1|Baseline|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
688649|NCT01931839|P7|Participant Flow|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
688820|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688650|NCT01931839|P6|Participant Flow|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
688651|NCT01931839|P5|Participant Flow|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
688652|NCT01931839|P4|Participant Flow|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
688653|NCT01931839|P3|Participant Flow|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
688654|NCT01931839|P2|Participant Flow|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
688655|NCT01931839|P1|Participant Flow|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
688656|NCT01931839|O1|Outcome|Arm 5: Part A Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening or LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening or placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), were observed (did not receive study drug) in this study VX12-809-105 (NCT01931839) for up to 2 years.
688657|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
688658|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211).
688659|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688660|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
688661|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688662|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
688663|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688664|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
688665|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688666|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
688667|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688668|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
688669|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688670|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
694357|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
688671|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688672|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
688673|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688674|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688675|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688676|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688677|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688678|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688679|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688680|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688681|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688682|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
688683|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688684|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688685|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688686|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688687|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688688|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who were randomized to LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
688689|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688690|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who were randomized to LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949).
688911|NCT01930487|E1|Reported Event|Supplement w/ Antioxidants|"dietary supplement with antioxidants~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688691|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688692|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
688693|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688694|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688695|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688696|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688697|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688698|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
688699|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688700|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688701|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688702|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688703|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688704|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
688705|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688706|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688707|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688708|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688709|NCT01931839|O2|Outcome|Arm 7: Part B Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688710|NCT01931839|O1|Outcome|Arm 6: Part B LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102 (NCT01225211), received the same treatment in this VX12-809-105 (NCT01931839) up to Week 96.
688788|NCT01931150|O1|Outcome|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688711|NCT01931839|O4|Outcome|Arm 4: Part A - Placebo- LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688712|NCT01931839|O3|Outcome|Arm 3: Part A - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688713|NCT01931839|O2|Outcome|Arm 2: Part A - Placebo- LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 (NCT01931839) up to Week 96.
688714|NCT01931839|O1|Outcome|Arm 1: Part A - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 (NCT01807923) or VX12-809-104 (NCT01807949), received the same treatment in this study VX12-809-105 (NCT01931839) up to Week 96.
688715|NCT01931839|E7|Reported Event|Arm 7 Part B: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in Cohort 4 of the previous study VX09-809-102, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
688716|NCT01931839|E6|Reported Event|Arm 6 Part B: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in Cohort 4 of the previous study VX09-809-102, received the same treatment in this study VX12-809-105 up to Week 96.
688717|NCT01931839|E5|Reported Event|Arm 5 Part A: Observational Cohort|Participants who received either LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening OR LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening OR placebo matched to LUM and IVA in the morning and evening, in the previous study VX12-809-103 or VX12-809-104, were observed (did not receive study drug) in this study VX12-809-105 for up to 2 years.
688718|NCT01931839|E4|Reported Event|Arm 4 Part A: Placebo - LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in this study VX12-809-105 up to Week 96.
688719|NCT01931839|E3|Reported Event|Arm 3 Part A: LUM 400 mg q12h/ IVA 250 mg q12h|Participants who received LUM 400 mg plus IVA 250 mg FDC tablet orally in the morning and evening in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
688720|NCT01931839|E2|Reported Event|Arm 2 Part A: Placebo - LUM 600 mg qd/ IVA 250 mg q12h|Participants who received placebo matched to LUM and IVA tablet in the previous study VX12-809-103 or VX12-809-104, received LUM 600 mg plus IVA 250 mg FDC tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening in this study VX12-809-105 up to Week 96.
688721|NCT01931839|E1|Reported Event|Arm 1 Part A: LUM 600 mg qd/ IVA 250 mg q12h|Participants who received lumacaftor (LUM, VX-809) 600 milligram (mg) plus ivacaftor (IVA, VX-770) 250 mg fixed-dose combination (FDC) tablet orally in the morning and IVA 250 mg film-coated tablet orally in the evening, in the previous study VX12-809-103 or VX12-809-104, received the same treatment in this study VX12-809-105 up to Week 96.
688722|NCT01931709|B1|Baseline|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
688723|NCT01931709|P1|Participant Flow|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
688724|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
688725|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
688726|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
688727|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
688728|NCT01931709|O2|Outcome|Patients Without Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class II /III (moderate to extensive residual disease)."
688912|NCT01930435|B1|Baseline|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
688729|NCT01931709|O1|Outcome|Patients With Favorable Pathologic Response|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to neoadjuvant chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~Pathologic response at surgery rated as residual cancer burden (RCB) class 0 / I (complete pathologic response or minimal residual disease)."
688730|NCT01931709|O1|Outcome|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
688731|NCT01931709|E1|Reported Event|Diagnostic (FDG PET and DCE-MRI)|"Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).~fludeoxyglucose F 18: Undergo FDG PET~positron emission tomography: Undergo FDG PET~dynamic contrast-enhanced magnetic resonance imaging: Undergo DCE-MRI~laboratory biomarker analysis: Correlative studies"
688732|NCT01931527|B3|Baseline|Total|Total of all reporting groups
688733|NCT01931527|B2|Baseline|High Uric Acid|15 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid >6mg/dL
688734|NCT01931527|B1|Baseline|Low Uric Acid|16 obese subjects (BMI 37.1±0.7 kg/m2) with uric acid <5mg/dL
688735|NCT01931527|P2|Participant Flow|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
688736|NCT01931527|P1|Participant Flow|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
688737|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
688738|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
688739|NCT01931527|O2|Outcome|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
688740|NCT01931527|O1|Outcome|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
688741|NCT01931527|E2|Reported Event|Obese Subjects With High Uric Acid|"Subjects with a body mass index = or > 30 kg/m2 with high uric acid (>6 mg/dL)~Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min~Rasburicase: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min"
688742|NCT01931527|E1|Reported Event|Obese Subjects With Normal Uric Acid|Subjects with a body mass index = or > 30 kg/m2 with normal uric acid (= or < 5 mg/dL)
688743|NCT01931475|B3|Baseline|Total|Total of all reporting groups
688744|NCT01931475|B2|Baseline|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688745|NCT01931475|B1|Baseline|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688746|NCT01931475|P2|Participant Flow|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment.1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688747|NCT01931475|P1|Participant Flow|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688748|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688749|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688789|NCT01931150|E2|Reported Event|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688750|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688751|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688752|NCT01931475|O1|Outcome|All Participants (60 mg Duloxetine & Placebo)|"Duloxetine:~Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg.~Placebo:~Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase:~1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment."
688753|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688754|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688755|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688756|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688757|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688758|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688759|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688760|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688761|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688790|NCT01931150|E1|Reported Event|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688791|NCT01930890|B5|Baseline|Total|Total of all reporting groups
688762|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688763|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688764|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688765|NCT01931475|O2|Outcome|Placebo|"Double Blind Treatment Phase:~Placebo administered by mouth once a day (QD) for 13 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.~Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs)."
688766|NCT01931475|O1|Outcome|60 mg Duloxetine|"Double Blind Treatment Phase:~60 milligram (mg) duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.~Extension Treatment Phase:~60 mg duloxetine administered by mouth QD for 13 weeks.~Taper Phase: 1-week taper where participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs)."
688767|NCT01931475|E6|Reported Event|Placebo Taper|Taper Phase: 1-week taper - Placebo administered for 1 week if the participant discontinued from double blind treatment phase, or duloxetine 30 mg QD administered for 1 week if the participant discontinued from extension treatment phase or completed treatment. 1 week taper is to minimize discontinuation-emergent adverse events (DEAEs).
688768|NCT01931475|E5|Reported Event|60 mg Duloxetine Taper|1-week taper - participants taking 60 mg QD duloxetine during the study had their dosage reduced to 30 mg to minimize discontinuation-emergent adverse events (DEAEs).
688769|NCT01931475|E4|Reported Event|Placebo/60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks. Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD.
688770|NCT01931475|E3|Reported Event|60 mg Duloxetine Extention|60 mg duloxetine administered by mouth QD for 13 weeks.
688771|NCT01931475|E2|Reported Event|Placebo Double Blind|Placebo administered by mouth once a day (QD) for 13 weeks.
688772|NCT01931475|E1|Reported Event|60 mg Duloxetine Double Blind|60 mg duloxetine administered by mouth once a day (QD). Started on duloxetine 30 mg QD for 1 week and then titrated up to 60 mg duloxetine QD for 12 weeks.
688773|NCT01931397|B1|Baseline|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
688774|NCT01931397|P1|Participant Flow|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
688775|NCT01931397|O1|Outcome|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
688776|NCT01931397|O2|Outcome|Group 2|Participants less than 12 years of age
688777|NCT01931397|O1|Outcome|Group 1|Participants 12 years and over
688778|NCT01931397|O2|Outcome|At End of Study|Numbers of families at end of study
688779|NCT01931397|O1|Outcome|At Time of Enrollment|Number of families at enrollment
688780|NCT01931397|O1|Outcome|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
688781|NCT01931397|E1|Reported Event|Total Cohort|This is a prospective non randomized study. All patients were approached at the pediatric kidney transplant clinic at OHSU in a non randomized fashion until the target enrollment of 30 patients was met.
688782|NCT01931150|B3|Baseline|Total|Total of all reporting groups
688783|NCT01931150|B2|Baseline|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688784|NCT01931150|B1|Baseline|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688785|NCT01931150|P2|Participant Flow|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688786|NCT01931150|P1|Participant Flow|Dapsone LEFT, Moisturizer RIGHT|Arm1: Receive oral antibiotics AND apply Dapsone 5% gel to LEFT side of face and chest BID (morning and evening), AND moisturizer to RIGHT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688787|NCT01931150|O2|Outcome|Dapsone RIGHT, Moisturizer LEFT|Arm 2: Receive oral antibiotics AND apply Dapsone 5% to RIGHT side of face and chest BID (morning and evening), AND moisturizer to LEFT side of face and chest BID (morning and evening), for 28 +/- 2 days.
688818|NCT01930487|P2|Participant Flow|Placebo, Then Supplement With Antioxidants|placebo supplement in the second intervention period, followed by dietary supplement with antioxidants in the second intervention period
688792|NCT01930890|B4|Baseline|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688793|NCT01930890|B3|Baseline|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688794|NCT01930890|B2|Baseline|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688795|NCT01930890|B1|Baseline|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688796|NCT01930890|P4|Participant Flow|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688797|NCT01930890|P3|Participant Flow|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688798|NCT01930890|P2|Participant Flow|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688799|NCT01930890|P1|Participant Flow|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus mycophenolate mofetil (MMF) and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg intavenously (IV) Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688800|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688801|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688802|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688803|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688804|NCT01930890|O4|Outcome|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688805|NCT01930890|O3|Outcome|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688806|NCT01930890|O2|Outcome|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688807|NCT01930890|O1|Outcome|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo every 4 weeks (Q4W) plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688808|NCT01930890|E4|Reported Event|BIIB023 20 mg/kg (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received BIIB023 20 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688809|NCT01930890|E3|Reported Event|Placebo (211LE201) to BIIB023 20 mg/kg (211LE202)|Participants who received placebo every Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 20 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688810|NCT01930890|E2|Reported Event|BIIB023 3 mg/kg (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received BIIB023 3 mg/kg Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688811|NCT01930890|E1|Reported Event|Placebo (211LE201) to BIIB023 3 mg/kg (211LE202)|Participants who received placebo Q4W plus MMF and oral corticosteroids in 211LE201 and received BIIB023 3 mg/kg IV Q4W plus MMF and oral corticosteroids through Week 100 in 211LE202.
688812|NCT01930799|B1|Baseline|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
688813|NCT01930799|P1|Participant Flow|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
688814|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
688815|NCT01930799|O1|Outcome|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
688816|NCT01930799|E1|Reported Event|All Enrolled Patients|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
688817|NCT01930487|B1|Baseline|Participants Completing Study|Participants who completed both arms of the crossover study
688916|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
688821|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688822|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688823|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688824|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688825|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688826|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688827|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688828|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688829|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688830|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688831|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688832|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688833|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688834|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688835|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688836|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688837|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688838|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688839|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688840|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688841|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688842|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688843|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688844|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688845|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688846|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688847|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688848|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688849|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688850|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688913|NCT01930435|P1|Participant Flow|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
688851|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688852|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688853|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688854|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688855|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688856|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688857|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688858|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688859|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688860|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688861|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688862|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688863|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688864|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688865|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688866|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688867|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688868|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688869|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688870|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688871|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688872|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688873|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688874|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688875|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688876|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688877|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688878|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688879|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688880|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688914|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
688881|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688882|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688883|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688884|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688885|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688886|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688887|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688888|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688889|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688890|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688891|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688892|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688893|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688894|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688895|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688896|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688897|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688898|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688899|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688900|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688901|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688902|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688903|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688904|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688905|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688906|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688907|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688908|NCT01930487|O2|Outcome|Placebo|"Placebo identical in appearance to active~Softgels manufactured to mimic the appearance of active dietary supplement with antioxidants"
688909|NCT01930487|O1|Outcome|Dietary Supplement With Antioxidants|"Dietary supplement with antioxidants, Ginkgo biloba, Bilberry extract~dietary supplement with antioxidants: Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids"
688910|NCT01930487|E2|Reported Event|Placebo|"placebo supplement~Placebo: Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants"
688915|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
688917|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device: This is a personal humidification device. It is hand held and produces sterile warm vapor."
688918|NCT01930435|O1|Outcome|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
688919|NCT01930435|E1|Reported Event|Sterile Humidification Device, MyPurMist|"Sterile Humidification Device Twice a day, 15 minutes each 12 weeks~Sterile Humidification Device"
688920|NCT01930058|B4|Baseline|Total|Total of all reporting groups
688921|NCT01930058|B3|Baseline|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688922|NCT01930058|B2|Baseline|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688923|NCT01930058|B1|Baseline|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
688924|NCT01930058|P3|Participant Flow|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688925|NCT01930058|P2|Participant Flow|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688926|NCT01930058|P1|Participant Flow|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 once daily (q.d.) by mouth for 7 days.
688927|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688928|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688929|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
688930|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688931|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688932|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
688933|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688934|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688935|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
688936|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688937|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688938|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
688939|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688940|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688941|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
688942|NCT01930058|O3|Outcome|Panel E: HCV GT1a MK-8876 800 mg|Participants infected with HCV GT1a received 800 mg MK-8876 q.d. by mouth for 7 days.
688943|NCT01930058|O2|Outcome|Panel B: HCV GT3 MK-8876 800 mg|Participants infected with HCV GT3 received 800 mg MK-8876 q.d. by mouth for 7 days.
688944|NCT01930058|O1|Outcome|Panel A: HCV GT3 MK-8876 150 mg|Participants infected with HCV GT3 received 150 mg MK-8876 q.d. by mouth for 7 days.
688945|NCT01930058|E2|Reported Event|MK-8876 800 mg|All HCV GT1a and GT3 participants treated with MK-8876 800 mg are included.
688946|NCT01930058|E1|Reported Event|MK-8876 150 mg|All HCV GT3 participants treated with MK-8876 150 mg are included.
688947|NCT01930045|B1|Baseline|All Participants|All enrolled participants
688948|NCT01930045|P6|Participant Flow|Ralt4MAL-MAL4Ralt-Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, MAL followed 4 hrs later by Ralt in Period 2, Ralt alone in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
688949|NCT01930045|P5|Participant Flow|MAL4Ralt-Ralt-Ralt4MAL-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt alone in Period 2, Ralt followed 4 hrs later by MAL in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
688950|NCT01930045|P4|Participant Flow|Ralt-Ralt4MAL-MAL4Ralt-Ralt6MAL-MAL6Ralt|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt alone in Period 1, Ralt followed 4 hrs later by MAL in Period 2, MAL followed 4 hrs later by Ralt in Period 3, Ralt followed 6 hrs later by MAL in Period 4, MAL followed 6 hrs later by Ralt in Period 5
688951|NCT01930045|P3|Participant Flow|Ralt4MAL-Ralt-MAL4Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Ralt followed 4 hrs later by MAL in Period 1, Ralt alone in Period 2, MAL followed 4 hrs later by Ralt in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
689004|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
688952|NCT01930045|P2|Participant Flow|MAL4Ralt-Ralt4MAL-Ralt-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: MAL followed 4 hrs later by Ralt in Period 1, Ralt followed 4 hrs later by MAL in Period 2, Ralt alone in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
688953|NCT01930045|P1|Participant Flow|Ralt-MAL4Ralt-Ralt4MAL-MAL6Ralt-Ralt6MAL|Part 1 was comprised of Periods 1, 2 and 3; Period 3 was followed by a Pause of up to 37 days, before Part 2; Part 2 was comprised of Periods 4 and 5. Each period was separated by a washout of at least 2 days. Each Period had single oral dose treatments as follows: Raltegravir (Ralt) alone in Period 1, MAALOX (MAL) followed 4 hrs later by Ralt in Period 2, Ralt followed 4 hrs later by MAL in Period 3, MAL followed 6 hrs later by Ralt in Period 4, Ralt followed 6 hrs later by MAL in Period 5
688954|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
688955|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
688956|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
688957|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
688958|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
688959|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
688960|NCT01930045|O3|Outcome|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
688961|NCT01930045|O2|Outcome|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
688962|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
688963|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
688964|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
688965|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
688966|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
688967|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
688968|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
688969|NCT01930045|O3|Outcome|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
688970|NCT01930045|O2|Outcome|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
688971|NCT01930045|O1|Outcome|Raltegravir|400 mg Raltegravir alone
688972|NCT01930045|E5|Reported Event|Raltegravir → 6 Hours → Maalox|400 mg Raltegravir followed 6 hrs later by 20 mL Maalox
688973|NCT01930045|E4|Reported Event|Maalox → 6 Hours → Raltegravir|20 mL Maalox followed 6 hrs later by 400 mg Raltegravir
688974|NCT01930045|E3|Reported Event|Raltegravir → 4 Hours → Maalox|400 mg Raltegravir followed 4 hrs later by 20 mL Maalox
688975|NCT01930045|E2|Reported Event|Maalox → 4 Hours → Raltegravir|20 mL Maalox followed 4 hrs later by 400 mg Raltegravir
688976|NCT01930045|E1|Reported Event|Raltegravir|400 mg Raltegravir alone
688977|NCT01929993|B3|Baseline|Total|Total of all reporting groups
688978|NCT01929993|B2|Baseline|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large loop excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
688979|NCT01929993|B1|Baseline|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
688980|NCT01929993|P2|Participant Flow|Large Loop Excision of the Transformation Zone (LLETZ-cone)|Large Loop Excision of the Transformation Zone (LLETZ-cone) is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
688981|NCT01929993|P1|Participant Flow|Straight Wire Excision of Transformation Zone (SWETZ)|Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix.
688982|NCT01929993|O2|Outcome|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
688983|NCT01929993|O1|Outcome|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
688984|NCT01929993|E2|Reported Event|LLETZ Cone|"LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.~LLETZ cone: LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin."
688985|NCT01929993|E1|Reported Event|SWETZ|"Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.~SWETZ: Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix."
688986|NCT01929980|B1|Baseline|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
729367|NCT01697696|E2|Reported Event|QAB149|75 μg once-daily
688987|NCT01929980|P1|Participant Flow|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
688988|NCT01929980|O1|Outcome|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
688989|NCT01929980|E1|Reported Event|Bortezomib|"Four doses of bortezomib, 1.3mg/m2, will be given intravenously (through a needle in a vein) or subcutaneously (under the skin) on Days 1, 4, 8, 11.~The format of receiving medications is- Therapy Dose and Route Frequency Rituximab 375 mg/m2 intravenously Once on day 1. Plasmapheresis 2 hours prior to Bortezomib Day 1,4, 8 and 11 Bortezomib 1.3 mg/m2 intravenously Day 1,4,8 and 11~Bortezomib"
688990|NCT01929889|B1|Baseline|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
688991|NCT01929889|P1|Participant Flow|A Single Arm, Open Label, Exploratory Study|This is a single arm, open label, exploratory study to examine effects of Fanapt (iloperadone) on social cognition. Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
688992|NCT01929889|O1|Outcome|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
688993|NCT01929889|E1|Reported Event|Iloperidone|Patients currently taking an antipsychotic medication other than Fanapt® will switch from their current medicine to Fanapt® in a cross-titration at a rate that is determined by the study physician. Treatment with iloperidone will be initiated and dosage will increase until the subject has achieved clinical stability, or has achieved the maximum dose, or 8 weeks have elapsed. Subjects who do not achieve clinical stability (as defined in the inclusion criteria) for the final 2 weeks in this 8-week period at the maximum dose of iloperidone will be discontinued from the study. If patients achieve stabilization, the lowest effective dose will be maintained. Subjects who have achieved clinical stability will then enter the 12-week treatment phase of the study.
688994|NCT01929876|B1|Baseline|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
688995|NCT01929876|P1|Participant Flow|Cobimetinib + Itraconazole|Cobimetinib 10 milligram (mg) (two 5 mg capsules) administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
688996|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
688997|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
688998|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
688999|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
689000|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
689001|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
689002|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
689003|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
689290|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689005|NCT01929876|O1|Outcome|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
689006|NCT01929876|E1|Reported Event|Cobimetinib + Itraconazole|Cobimetinib 10 mg administered orally on Day 1 of Period 1 and Day 4 of Period 2. Each period duration was 14 days. Itraconazole 200 mg oral solution was administered once daily from Day 1 to Day 14 of Period 2.
689007|NCT01929473|B1|Baseline|Blood Drawings (0 Day, 365 Day) and Questionnaires|
689008|NCT01929473|P1|Participant Flow|Blood Drawings (0 Day, 365 Day) and Questionnaires|
689009|NCT01929473|O1|Outcome|Blood Drawings (0 Day, 365 Day) and Questionnaires|
689010|NCT01929473|E1|Reported Event|Blood Drawings (0 Day, 365 Day) and Questionnaires|
689011|NCT01929460|B3|Baseline|Total|Total of all reporting groups
689012|NCT01929460|B2|Baseline|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689013|NCT01929460|B1|Baseline|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689014|NCT01929460|P2|Participant Flow|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689015|NCT01929460|P1|Participant Flow|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their Endoscopic Ultrasound (EUS)-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689016|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689017|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689018|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689019|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689020|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689021|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689022|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689023|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689024|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689025|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689026|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689027|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689028|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689029|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689030|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689031|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689032|NCT01929460|O2|Outcome|Placebo (Intervention Group)|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689033|NCT01929460|O1|Outcome|Ciprofloxacin (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689034|NCT01929460|E2|Reported Event|Intervention Group|"Intervention group: this group will receive three days of oral PLACEBO after their EUS-guided pancreas cyst aspiration~Oral Placebo, one cap twice a day for three days.~Placebo (for ciprofloxacin)"
689035|NCT01929460|E1|Reported Event|Drug (Standard Group)|"Standard group: this group will receive three days of oral antibiotics after their EUS-guided pancreas cyst aspiration.~Ciprofloxacin 500mg by mouth twice a day for three days.~Ciprofloxacin"
689036|NCT01929317|B3|Baseline|Total|Total of all reporting groups
689037|NCT01929317|B2|Baseline|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689038|NCT01929317|B1|Baseline|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689039|NCT01929317|P2|Participant Flow|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg per day administered orally OD for 4 weeks in the Screening phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
689040|NCT01929317|P1|Participant Flow|Ropinirole CR - High Dose Group|Participants received ropinirole controlled released (CR) 16 milligrams (mg) administered orally once daily (OD) for 4 weeks in the Screening Phase. After randomization, participants entered the Dose Increase Effect Verification Phase, where ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24 mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. After the completion of the Dose Increase Effect Verification Phase, participants entered the Down Titration Phase for 1 week and selected participants entered the Long-term Phase for 39 weeks.
689041|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689042|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689043|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689044|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
695358|NCT01890148|E1|Reported Event|AZD5069|AZD5069 45mg oral twice daily (BID)
689045|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689046|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689047|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689048|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689049|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689050|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689051|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689114|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
689291|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689292|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689052|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689053|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689054|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689055|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689056|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689057|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689058|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689115|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
689152|NCT01929044|P1|Participant Flow|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689059|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689060|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689061|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689062|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689063|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689064|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689065|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689116|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
689153|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
695359|NCT01890122|B5|Baseline|Total|Total of all reporting groups
689066|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689067|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689068|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689069|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689070|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689071|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689072|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689117|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
689293|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
729368|NCT01697696|E1|Reported Event|NVA237|12.5 μg twice-daily
689073|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689074|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689075|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689076|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689077|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689078|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689079|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689118|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
689157|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
689080|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689081|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689082|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689083|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689084|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689085|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689086|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689119|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
689154|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689087|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689088|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689089|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689090|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689091|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689092|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689093|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689120|NCT01929135|O1|Outcome|Atorvastatin Toothpaste|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
689155|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
729369|NCT01697592|B11|Baseline|Total|Total of all reporting groups
689094|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689095|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689096|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689097|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689098|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689099|NCT01929317|O2|Outcome|Ropinirole CR - Maintenance Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689100|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689121|NCT01929135|E2|Reported Event|Placebo Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus placebo dentifrice.Therapy was supplemented with oral hygiene instruction, indicating patients to brush with dentifrice 2 times a day for two minutes each time, for 30 days.~Non medicated dentifrice: fluoride dentifrice."
689156|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
697556|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
689101|NCT01929317|O1|Outcome|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689102|NCT01929317|E4|Reported Event|Ropinirole CR - Maintenance Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689103|NCT01929317|E3|Reported Event|Ropinirole CR - High Dose Group: Long Term Phase|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689104|NCT01929317|E2|Reported Event|Ropinirole CR - Maintenance Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization participants entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was maintained at 16 mg/day and the placebo was titrated to maintain blinding at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689105|NCT01929317|E1|Reported Event|Ropinirole CR - High Dose Group|Participants received ropinirole CR 16 mg administered orally OD for 4 weeks in the Screening Phase. After randomization the participant entered Dose Increase Effect Verification Phase, where Ropinirole CR dose was titrated (2 mg/day/week) from 18 mg/day up to a maximum 24mg/day at intervals of 1 week or longer for 8 weeks, until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose for 4 weeks. This was followed by a down titration phase for one week and Long-term Phase for 39 weeks in which the participants received incremental doses (2 mg/day/week) of ropinirole CR from 18 mg/day to a maximum of 24 mg/day until participants reached a dose level above which further symptomatic improvement was not expected; the participants were maintained on that dose. Participants completed the Long-term Phase underwent a down titration phase 2 for 1 to 2 weeks.
689106|NCT01929135|B3|Baseline|Total|Total of all reporting groups
689107|NCT01929135|B2|Baseline|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
689108|NCT01929135|B1|Baseline|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days.
689109|NCT01929135|P2|Participant Flow|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
689110|NCT01929135|P1|Participant Flow|Atorvastatin Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time for a period of 30 days..
689111|NCT01929135|O2|Outcome|Placebo Group|A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
689112|NCT01929135|O1|Outcome|Atorvastatin Group|"A group of 19 patients will receive the Atorvastatin 2% toothpaste. Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin: Toothpaste with Atorvastatin 2% (20 mg per ml), brushing 1 minute 2 time a day, for 30 days."
689113|NCT01929135|O2|Outcome|Non Medicated Gel Toothpaste|"A group of 19 patients will receive a toothpaste without the drug to act as a placebo.Therapy will be supplemented with oral hygiene instruction, indicating patients to brush with the toothpaste that will be provided, 2 times a day for two minutes each time, for 30 days.~Non medicated gel toothpaste: Normal gel toothpaste used as placebo, brushing 1 minute 2 time a day, for 30 days."
689151|NCT01929044|P2|Participant Flow|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
730083|NCT01694108|O2|Outcome|Control Children|No intervention
689122|NCT01929135|E1|Reported Event|Atorvastatin Group|"A group of 19 patients received Non-surgical periodontal treatment (NSPT) plus medicated 2% atorvastatin dentifrice. Therapy was supplemented with oral hygiene instruction, indicating patients to brush with the dentifrice 2 times a day for two minutes each time for a period of 30 days.~Atorvastatin dentifrice: fluoride dentifrice with 2% Atorvastatin (20 mg per ml)."
689123|NCT01929083|B1|Baseline|Entire Study Population|n=15 subjects who completed the study
689124|NCT01929083|P2|Participant Flow|Placebo First, Then Progesterone|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689125|NCT01929083|P1|Participant Flow|Progesterone First, Then Placebo|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689126|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689127|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689128|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689129|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689130|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689131|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689132|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689133|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689134|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689135|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689136|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689137|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689138|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689139|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689140|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689141|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689142|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689143|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689144|NCT01929083|O2|Outcome|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689145|NCT01929083|O1|Outcome|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689146|NCT01929083|E2|Reported Event|Placebo|"Subjects will receive oral placebo, two capsules once daily every evening for 7 days~Placebo: Subjects will receive oral placebo two capsules once daily every evening for 7 days"
689147|NCT01929083|E1|Reported Event|Progesterone|"Subjects will receive treatment with oral progesterone 400 mg once daily (two x 200 mg capsules) every evening for 7 days~Progesterone: Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days"
689148|NCT01929044|B3|Baseline|Total|Total of all reporting groups
689149|NCT01929044|B2|Baseline|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
689150|NCT01929044|B1|Baseline|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689158|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689159|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
689160|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689161|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
689162|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689163|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
689164|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689165|NCT01929044|O2|Outcome|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
689166|NCT01929044|O1|Outcome|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689167|NCT01929044|E2|Reported Event|654-II (Anisodamine)|Single intramuscular injection of 10 mg Anisodamine solution (if needed, second injection with 10 mg was to be made at 20 min after the first one) was administered to the patients
689168|NCT01929044|E1|Reported Event|Buscopan® (Hyoscine Butylbromide)|Single intramuscular injection of 20 mg Buscopan® solution (if needed, second injection with 20 mg was to be made at 20 min after the first one) was administered to the patients
689169|NCT01929031|B5|Baseline|Total|Total of all reporting groups
689170|NCT01929031|B4|Baseline|Ibuprofen/Caffeine Stage 1|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
689171|NCT01929031|B3|Baseline|Ibuprofen Stage 1|One Ibuprofen 400mg tablet after dental surgery
689172|NCT01929031|B2|Baseline|Caffeine Stage 1|One Caffeine 100mg tablet after dental surgery
689173|NCT01929031|B1|Baseline|Placebo Stage 1|One Placebo tablet after dental surgery
689174|NCT01929031|P6|Participant Flow|Placebo - Ibuprofen|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
689175|NCT01929031|P5|Participant Flow|Placebo - Ibuprofen/Caffeine|Study stage 1: One Placebo tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
689176|NCT01929031|P4|Participant Flow|Caffeine - Ibuprofen|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
689177|NCT01929031|P3|Participant Flow|Caffeine - Ibuprofen/Caffeine|Study stage 1: One Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg/Caffeine 100mg tablet, while awake, over 5 days
689178|NCT01929031|P2|Participant Flow|Ibuprofen - Ibuprofen|Study stage 1: One Ibuprofen 400mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen 400mg tablet, while awake, over 5 days
689179|NCT01929031|P1|Participant Flow|Ibuprofen/Caffeine - Ibuprofen/Caffeine|Study stage 1: One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery; Study stage 2: Subsequent to stage 1, every 6-8 hours one Ibuprofen400mg/Caffeine 100mg tablet, while awake, over 5 days
689180|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
689181|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
689182|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
689183|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
689184|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
689185|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
689186|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
689187|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
689188|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
689189|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
689190|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
689191|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
689192|NCT01929031|O4|Outcome|Ibuprofen/Caffeine|One Ibuprofen 400mg/Caffeine 100mg tablet after dental surgery
689193|NCT01929031|O3|Outcome|Ibuprofen|One Ibuprofen 400mg tablet after dental surgery
689194|NCT01929031|O2|Outcome|Caffeine|One Caffeine 100mg tablet after dental surgery
689195|NCT01929031|O1|Outcome|Placebo|One Placebo tablet after dental surgery
689196|NCT01929031|E4|Reported Event|Ibuprofen/Caffeine|Ibuprofen 400mg / Caffeine 100mg tablet
689197|NCT01929031|E3|Reported Event|Ibuprofen|Ibuprofen 400mg tablet
689198|NCT01929031|E2|Reported Event|Caffeine|Caffeine 100mg tablet
689199|NCT01929031|E1|Reported Event|Placebo|Placebo tablet
689200|NCT01928940|B3|Baseline|Total|Total of all reporting groups
689276|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689277|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689278|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
730084|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
689201|NCT01928940|B2|Baseline|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689202|NCT01928940|B1|Baseline|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689203|NCT01928940|P2|Participant Flow|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689204|NCT01928940|P1|Participant Flow|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689205|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689206|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689207|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689208|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689209|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689210|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689279|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689280|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689281|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689282|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689283|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689211|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689212|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689213|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689214|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689215|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689216|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689217|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689218|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689219|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689220|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689221|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689222|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689223|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689224|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689225|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689226|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689227|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689228|NCT01928940|O1|Outcome|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689229|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689230|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689284|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689285|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689286|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689287|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689288|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689231|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689232|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689233|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689234|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689235|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689236|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689237|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689238|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689239|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689240|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689241|NCT01928940|O1|Outcome|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 milligrams (mg) (a combination of 75 mg capsules) orally twice daily (BID) and GSK1120212 2 mg tablet orally once daily (QD) until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hours (hr) after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial pharmacokinetic (PK) blood sampling. Study drugs were taken with approximately 200 milliliters (mL) of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689242|NCT01928940|E2|Reported Event|Phase II: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase II part, participants with BRAF V600E/K mutation-positive cutaneous melanoma received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689243|NCT01928940|E1|Reported Event|Phase I: GSK2118436 150 mg + GSK1120212 2 mg|In the Phase I part, participants with BRAF V600E/K mutation-positive advanced solid tumors received the combination therapy of GSK2118436 150 mg (a combination of 75 mg capsules) orally BID and GSK1120212 2 mg tablet orally QD until disease progression, death or an unacceptable adverse event. GSK2118436 and GSK1120212 were administered in the morning at approximately the same time. The second dose of GSK2118436 was taken in the evening approximately 12 hr after the morning dose. The second dose of GSK2118436 was not administered on Day 1 for the 24 hr serial PK blood sampling. Study drugs were taken with approximately 200 mL of water under fasting conditions, either 1 hr before or 2 hr after a meal.
689244|NCT01928927|B3|Baseline|Total|Total of all reporting groups
689245|NCT01928927|B2|Baseline|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
689246|NCT01928927|B1|Baseline|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
689247|NCT01928927|P2|Participant Flow|Arm B: No Study Drug|"Participants will receive no study drug and will follow week 0-48 evaluation schedule.~Control"
689248|NCT01928927|P1|Participant Flow|Arm A: Telmisartan|"Participants will receive Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
689249|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and were followed week 0-48 evaluation schedule.~Control"
689250|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
689251|NCT01928927|O2|Outcome|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.~Control"
689252|NCT01928927|O1|Outcome|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
689253|NCT01928927|E2|Reported Event|Arm B: No Study Drug|"Participants received no study drug and will follow week 0-48 evaluation schedule.~Control"
689254|NCT01928927|E1|Reported Event|Arm A: Telmisartan|"Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.~Telmisartan"
689255|NCT01928771|B4|Baseline|Total|Total of all reporting groups
689256|NCT01928771|B3|Baseline|Placebo|Placebo administered subcutaneously
689257|NCT01928771|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689258|NCT01928771|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689259|NCT01928771|P3|Participant Flow|Placebo|Placebo administered subcutaneously
689260|NCT01928771|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689261|NCT01928771|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689262|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689263|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689264|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689265|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689266|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689267|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689268|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689269|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689270|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689271|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689272|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689273|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689274|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689275|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689296|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689297|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689298|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689299|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689300|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689301|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689302|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689303|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689304|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689305|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689306|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689307|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689308|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689309|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689310|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689311|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689312|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689313|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689314|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689315|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689316|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689317|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689318|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689319|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689320|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689321|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689322|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689323|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689324|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689325|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689326|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689327|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689328|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689329|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689330|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689331|NCT01928771|O3|Outcome|Placebo|Placebo administered subcutaneously
689332|NCT01928771|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689333|NCT01928771|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689334|NCT01928771|E3|Reported Event|Placebo|Placebo administered subcutaneously
689335|NCT01928771|E2|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered every 8 weeks subcutaneously.
689336|NCT01928771|E1|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered every 4 weeks subcutaneously.
689337|NCT01928693|B4|Baseline|Total|Total of all reporting groups
689338|NCT01928693|B3|Baseline|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689339|NCT01928693|B2|Baseline|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689340|NCT01928693|B1|Baseline|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689341|NCT01928693|P3|Participant Flow|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689400|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
729492|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
689342|NCT01928693|P2|Participant Flow|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689343|NCT01928693|P1|Participant Flow|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689344|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689345|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689346|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689347|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689348|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689349|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689350|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689351|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689352|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689353|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689394|NCT01928472|P2|Participant Flow|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689395|NCT01928472|P1|Participant Flow|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689396|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689354|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689355|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689356|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689357|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689358|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689359|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689360|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689361|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689362|NCT01928693|O3|Outcome|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689363|NCT01928693|O2|Outcome|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689364|NCT01928693|O1|Outcome|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689365|NCT01928693|E3|Reported Event|Vigamox 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Vigamox 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689397|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689398|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689399|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689366|NCT01928693|E2|Reported Event|Zymaxid 0.5% Ophthalmic Solution|"A topical fluoroquinolone anti-infective indicated for the treatment of bacterial conjunctivitis.~Zymaxid 0.5% Ophthalmic Solution: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689367|NCT01928693|E1|Reported Event|Besivance 0.6% Ophthalmic Suspension|"A topical fluoroquinolone antimicrobial indicated for the treatment of bacterial conjunctivitis.~Besivance 0.6% Ophthalmic Suspension: Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours."
689368|NCT01928680|B1|Baseline|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
689369|NCT01928680|P1|Participant Flow|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
689370|NCT01928680|O1|Outcome|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
689371|NCT01928680|E1|Reported Event|Cisplatin/Capecitabine|"Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity.~This is a single arm phase II clinical trial.~Cisplatin/Capecitabine: Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity"
689372|NCT01928615|B1|Baseline|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689373|NCT01928615|P1|Participant Flow|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689374|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689375|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689376|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689377|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689514|NCT01927575|O3|Outcome|Tomosynthesis|"Tomosynthesis imaging to be compared to standard of care CT and X-ray~No AEs"
689378|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689379|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689380|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689381|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689382|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689383|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689384|NCT01928615|O2|Outcome|Trastuzumab - Upper Arm First, Then Thigh|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the upper arm for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the thigh for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689385|NCT01928615|O1|Outcome|Trastuzumab - Thigh First, Then Upper Arm|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants received trastuzumab 600 mg subcutaneously (SC) every 3 weeks into the thigh for 12 weeks (Cycles 7-10) followed by trastuzumab 600 mg SC every 3 weeks into the upper arm for 12 weeks (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689386|NCT01928615|E1|Reported Event|Trastuzumab|In the run-in phase, participants received trastuzumab intravenously every 3 weeks for 18 weeks (Cycles 1-6). They first received trastuzumab 8 mg/kg once (Cycle 1) followed by trastuzumab 6 mg/kg 5 times for 15 weeks (Cycles 2-6). Following the run-in phase, participants were randomized to receive trastuzumab 600 mg subcutaneously every 3 weeks in the thigh and upper arm in a cross-over design for a total of 24 weeks (Cycles 7-14). They received trastuzumab either in the thigh first for 4 cycles (Cycles 7-10) followed by trastuzumab in the upper arm for 4 cycles (Cycles 11-14) or the upper arm first (Cycles 7-10) followed by the thigh (Cycles 11-14). In Cycles 15-18, participants received trastuzumab 600 mg SC every 3 weeks into either the thigh or the upper arm (participant’s choice) for 12 weeks (Cycles 15-18).
689387|NCT01928472|B5|Baseline|TOTAL|Total of all reporting groups
689388|NCT01928472|B4|Baseline|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689389|NCT01928472|B3|Baseline|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689390|NCT01928472|B2|Baseline|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689391|NCT01928472|B1|Baseline|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689392|NCT01928472|P4|Participant Flow|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689393|NCT01928472|P3|Participant Flow|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689401|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689402|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689403|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689404|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689405|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689406|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689407|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689408|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689409|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689410|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689411|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689412|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689413|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689414|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689415|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689416|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689417|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689418|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689419|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689420|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689421|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689422|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689423|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689424|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689425|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689426|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689427|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689428|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689429|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689430|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689431|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689432|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689433|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689434|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689435|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689436|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689437|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689438|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689439|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689440|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689441|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689442|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689443|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689444|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689445|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689446|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689447|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689448|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689449|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689450|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689451|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689452|NCT01928472|O4|Outcome|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689453|NCT01928472|O3|Outcome|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689454|NCT01928472|O2|Outcome|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689455|NCT01928472|O1|Outcome|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart
689456|NCT01928472|E5|Reported Event|TOTAL|Total of all reporting groups.
689457|NCT01928472|E4|Reported Event|High Dose + No Adj|Subjects received two doses of unadjuvanted of H7N9c vaccine formulation, administered three weeks apart.
689458|NCT01928472|E3|Reported Event|High Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689459|NCT01928472|E2|Reported Event|Medium Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689460|NCT01928472|E1|Reported Event|Low Dose + Adj|Subjects received two doses of MF59 adjuvanted H7N9c vaccine formulation, administered three weeks apart.
689461|NCT01928381|B1|Baseline|Overall Study|Overall Study - Starting with Part 1
689462|NCT01928381|P7|Participant Flow|Sequence 6|Sequence 6 - 1st AZD5213 + pregabalin, 2nd pregabalin, 3rd placebo
689463|NCT01928381|P6|Participant Flow|Sequence 5|Sequence 5 - 1st AZD5213 + pregabalin, 2nd placebo, 3rd pregabalin
689464|NCT01928381|P5|Participant Flow|Sequence 4|Sequence 4 - 1st pregabalin, 2nd AZD5213 + pregabalin, 3rd placebo
689465|NCT01928381|P4|Participant Flow|Sequence 3|Sequence 3 - 1st pregabalin, 2nd placebo, 3rd AZD5213 + pregabalin
689466|NCT01928381|P3|Participant Flow|Sequence 2|Sequence 2 - 1st Placebo, 2nd AZD5213 + pregabalin, 3rd pregabalin
689467|NCT01928381|P2|Participant Flow|Sequence 1|Sequence 1 - 1st placebo, 2nd pregabalin, 3rd AZD5213 + pregabalin
689468|NCT01928381|P1|Participant Flow|Part 1 - Pain Training|Part 1 - Screening, Pain Training, placebo run-in eligibility for Part 2
689469|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
689470|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
689471|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
689472|NCT01928381|O3|Outcome|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
689473|NCT01928381|O2|Outcome|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
689474|NCT01928381|O1|Outcome|Part 2 - Placebo|Part 2 - placebo crossover periods
689475|NCT01928381|E5|Reported Event|Overall Study|Overall Study: Part 1 and Part 2
689476|NCT01928381|E4|Reported Event|Part 2 - Pregabalin|Part 2 pregabalin crossover periods
689477|NCT01928381|E3|Reported Event|Part 2 - Pregabalin + AZD5213|Part 2 - Combined pregabalin + AZD5213 crossover periods
689478|NCT01928381|E2|Reported Event|Part 2 - Placebo|Part 2 - placebo crossover periods
689479|NCT01928381|E1|Reported Event|Part 1|Part 1 - Pain training + 1 week of single blind placebo
689480|NCT01928030|B1|Baseline|Hyaluronidase, Recombinant Human|Patients receive recombinant human hyaluronidase 450 units or 900 units SC on days 1, 3, 5, and 7 (Phase 1) and then on days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
689481|NCT01928030|P3|Participant Flow|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
689482|NCT01928030|P2|Participant Flow|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
689483|NCT01928030|P1|Participant Flow|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
689484|NCT01928030|O3|Outcome|MTD rHuPH20 (Days 1 to 21)|Days 1 to 21 Patients receive the maximum tolerated dose (MTD) of rHuPH20 SC on days 1 to 21.
689485|NCT01928030|O2|Outcome|900 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 900 units rHuPH20 SC on days 1, 3, 5, and 7
689486|NCT01928030|O1|Outcome|450 Units rHuPH20 (Days 1, 3, 5, and 7)|Patients receive 450 units rHuPH20 SC on days 1, 3, 5, and 7
689487|NCT01928030|O1|Outcome|450 Units Recombinant Human Hyaluronidase (rHuPH20)|Participants receive 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously (SC) on Days 1, 3, 5, and 7 (Phase 1) and then on Days 1 to 21 (Phase 2) in the absence of disease progression or unacceptable toxicity.
689488|NCT01928030|E1|Reported Event|Recombinant Human Hyaluronidase|"Participants who received 450 units recombinant human hyaluronidase (rHuPH20) subcutaneously in Phase 1 were assessed in this outcome measure, treatment-related adverse events.~Biomarker analysis and pharmacology study were performed during study.~recombinant human hyaluronidase: Given subcutaneously"
689515|NCT01927575|O2|Outcome|Standard CT|"Standard of care CT imaging to be compared with research imaging device.~Followed by Tomo imaging~No AE's"
689516|NCT01927575|O1|Outcome|Standard X-Ray|"Standard of care X-Ray imaging to be compared with research imaging device.~Followed by Tomo imaging~No AE's"
689517|NCT01927575|E3|Reported Event|Tomo|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging~No AE's during X-ray, CT or Tomo."
689542|NCT01927055|B1|Baseline|Open-Label|Patients entered open label droxidopa dose titration, but did not proceed into the randomization phase.
689489|NCT01927887|B1|Baseline|Nanoparticle Enhanced MRI|"Each subject will have one MRI scan at MGH. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed.The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
689490|NCT01927887|P1|Participant Flow|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols.Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec.
689491|NCT01927887|O1|Outcome|Nanoparticle MRI|Nanoparticle MRI: Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
689492|NCT01927887|O1|Outcome|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
689493|NCT01927887|E1|Reported Event|Lymphotrophic Superparamagnetic Nanoparticles (LSN MRI)|"Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.~Ferumoxytol: Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.~lymphotrophic superparamagnetic nanoparticle"
689494|NCT01927757|B1|Baseline|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689495|NCT01927757|P1|Participant Flow|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689496|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689497|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689498|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689499|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689500|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689501|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689502|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689503|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689504|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689505|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689506|NCT01927757|O2|Outcome|Secondary Failure|Participants who lost a satisfactory response (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 6 months.
689507|NCT01927757|O1|Outcome|Primary Failure|Participants failed to respond (defined as achievement of ACR20 or equivalent as judged by the investigator) to a combination treatment of adalimumab and methotrexate. This combination treatment must have been taken for at least 3 months.
689508|NCT01927757|O2|Outcome|Absence of Anti-adalimumab Antibodies|Participants with absence of anti-adalimumab antibodies.
689509|NCT01927757|O1|Outcome|Presence of Anti-adalimumab Antibodies|Participants with anti-adalimumab antibodies.
689510|NCT01927757|O1|Outcome|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689511|NCT01927757|E1|Reported Event|Etanercept|Participants received 50 mg etanercept once weekly by subcutaneous injection with methotrexate for 24 weeks.
689512|NCT01927575|B1|Baseline|All Study Participants|"Standard X-Ray + CT arm to be used as comparative arm for investigational imaging device. Investigators will determine standard of care to be used on a per subject basis.~Standard X-Ray + CT: Standard of Care X-Ray Imaging + CT~Followed by Tomo Imaging"
689513|NCT01927575|P1|Participant Flow|All Study Participants|"Standard of care X-Ray imaging plus CT to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging + CT~Followed by Tomo Imaging"
689518|NCT01927575|E2|Reported Event|Standard CT|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging~No AE's during X-ray, CT or Tomo."
689519|NCT01927575|E1|Reported Event|Standard X-Ray|"Standard of care X-Ray, and CT imaging to be compared with research imaging device.~Standard X-Ray: Standard of Care X-Ray Imaging~Followed by Tomo imaging~No AE's during X-ray, CT or Tomo."
689520|NCT01927419|B3|Baseline|Total|Total of all reporting groups
689521|NCT01927419|B2|Baseline|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689522|NCT01927419|B1|Baseline|Nivolumab + Ipilimumab|Participants received (Part) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689523|NCT01927419|P2|Participant Flow|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689524|NCT01927419|P1|Participant Flow|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689525|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689526|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689527|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689528|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) until documented disease progression, toxicity, withdrawal of consent, or study completion.
689529|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689530|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689531|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689532|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689533|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689534|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689535|NCT01927419|O2|Outcome|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689536|NCT01927419|O1|Outcome|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689537|NCT01927419|E2|Reported Event|Placebo + Ipilimumab|Participants received (Part 1) placebo-matching nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) placebo-matching nivolumab solution intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689538|NCT01927419|E1|Reported Event|Nivolumab + Ipilimumab|Participants received (Part 1) 1 mg/kg of nivolumab + 3 mg/kg of ipilimumab solution intravenously every 3 weeks for 4 doses (4 cycles), then (Part 2) 3 mg/kg of nivolumab intravenously every 2 weeks until documented disease progression, toxicity, withdrawal of consent, or study completion.
689539|NCT01927055|B4|Baseline|Total|Total of all reporting groups
689540|NCT01927055|B3|Baseline|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations. 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
689541|NCT01927055|B2|Baseline|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
689543|NCT01927055|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
689544|NCT01927055|P2|Participant Flow|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
689545|NCT01927055|P1|Participant Flow|Open-label Titration|"Droxidopa 100 mg, 200 mg~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 2 weeks of treatment"
689546|NCT01927055|O2|Outcome|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
689547|NCT01927055|O1|Outcome|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: Droxidopa at 100 mg, 200 mg, 300 mg"
689548|NCT01927055|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo to match droxidopa capsules and strength designations"
689549|NCT01927055|E2|Reported Event|Droxidopa|"Droxidopa 100 mg, 200 mg, 300 mg~Droxidopa: 100 mg, 200 mg and 300 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 12 weeks of treatment"
689550|NCT01927055|E1|Reported Event|Open-label Titration|All patients treated with study drug during dose titration (1-14 days)
689551|NCT01926977|B3|Baseline|Total|Total of all reporting groups
689552|NCT01926977|B2|Baseline|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
689553|NCT01926977|B1|Baseline|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
689554|NCT01926977|P2|Participant Flow|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
689555|NCT01926977|P1|Participant Flow|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
689556|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
689557|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
689558|NCT01926977|O2|Outcome|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
689559|NCT01926977|O1|Outcome|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
689560|NCT01926977|E2|Reported Event|Aflibercept 2.0mg Intravitreal Injection|"Intravitreal Aflibercept 2.0mg once~Aflibercept 2.0mg: Patients will receive intravitreal injection of Aflibercept 2.0mg."
689561|NCT01926977|E1|Reported Event|Ranibizumab 0.5mg Intravitreal Injection|"Intravitreal injection of Ranibizumab 0.5mg once~Ranibizumab 0.5mg: Patient will receive intravitreal injection of Ranibizumab 0.5mg."
689562|NCT01926782|B7|Baseline|Total|Total of all reporting groups
689563|NCT01926782|B6|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689564|NCT01926782|B5|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689565|NCT01926782|B4|Baseline|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689566|NCT01926782|B3|Baseline|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689567|NCT01926782|B2|Baseline|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689568|NCT01926782|B1|Baseline|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689569|NCT01926782|P6|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689570|NCT01926782|P5|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689571|NCT01926782|P4|Participant Flow|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689592|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
691178|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
690025|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
689572|NCT01926782|P3|Participant Flow|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689573|NCT01926782|P2|Participant Flow|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689574|NCT01926782|P1|Participant Flow|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689575|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689576|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689577|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689578|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689579|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689580|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689581|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689582|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689583|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689584|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689585|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689586|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689587|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689588|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689589|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689590|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689591|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689593|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689594|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689595|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689596|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689597|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689598|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689599|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689600|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689601|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689602|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689603|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689604|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689605|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689606|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689607|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689608|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689609|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689610|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689611|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689612|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689613|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689614|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689615|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689616|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689617|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689618|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689619|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689620|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689621|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689622|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689623|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689624|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689625|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689626|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689627|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689628|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689629|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689630|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689631|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689632|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689673|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689633|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689634|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689635|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689636|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689637|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689638|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689639|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689640|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689641|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689642|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
689643|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689644|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689645|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689646|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689647|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689648|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689649|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689650|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689651|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689652|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689694|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
730085|NCT01694108|O2|Outcome|Control Children|No intervention
689653|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689654|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689655|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689656|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689657|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689658|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689659|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689660|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689661|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689662|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
689663|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689664|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689665|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689666|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689667|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689668|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
689669|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689670|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689671|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689672|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689674|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689675|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689676|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689677|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689678|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689679|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689680|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689681|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689682|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689683|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689684|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689685|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689686|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689687|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689688|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689689|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689690|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689691|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689692|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689693|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8"
689695|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689696|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689697|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689698|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8
689699|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689700|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689701|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689702|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689703|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689704|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689705|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689706|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689707|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689708|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689709|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689710|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689711|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689712|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689713|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W With Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W with stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689714|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W With Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W with stable statin therapy for 48 weeks.~Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689715|NCT01926782|O1|Outcome|Placebo Q2W With Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) with stable statin therapy for 48 weeks.
689716|NCT01926782|O3|Outcome|Alirocumab 300 mg Q4W/Up 150 mg Q2W Without Concomitant Statin|Two SC injections of Alirocumab 150 mg every 4 weeks (Q4W) alternating with two SC injections of placebo Q4W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689717|NCT01926782|O2|Outcome|Alirocumab 75 mg Q2W/Up 150 mg Q2W Without Concomitant Statin|"One SC injection of each Alirocumab 75 mg and placebo Q2W without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg every two weeks (Q2W) from Week 12 when LDL-C levels~≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8."
689718|NCT01926782|O1|Outcome|Placebo Q2W Without Concomitant Statin|Two Subcutaneous (SC) injections of placebo (for alirocumab) every two weeks (Q2W) without stable statin therapy for 48 weeks.
689719|NCT01926782|E3|Reported Event|Alirocumab 300 mg Q4W/Up 150 mg Q2W|Two SC injections of Alirocumab 300 mg Q4W alternating with two SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689720|NCT01926782|E2|Reported Event|Alirocumab 75 mg Q2W/Up 150 mg Q2W|One SC injection of Alirocumab 150 mg Q4W alternating with 2 SC injections of placebo Q4W with or without stable statin therapy for 48 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) (for very high CV risk subjects) or ≥ 100 mg/dL (2.59 mmol/L) (for moderate and high CV risk subjects) at Week 8.
689721|NCT01926782|E1|Reported Event|Placebo Q2W|Two SC injections of placebo (for alirocumab) Q2W with or without stable statin therapy for 48 weeks.
689722|NCT01926626|B1|Baseline|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689723|NCT01926626|P1|Participant Flow|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689724|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689725|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689726|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689727|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
690021|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
689728|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689729|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689730|NCT01926626|O1|Outcome|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689731|NCT01926626|E1|Reported Event|Nicotine Patch+Moclobemide|"After 1 week of pre-cessation nicotine patch treatment (21 mg/24 h patches), participants will receive moclobemide (400 mg/day in 2 divided doses) for 11 weeks, ending 10 weeks after the target quit date. Nicotine patch treatment will continue at 21 mg/24 h for an additional week prior to the quit date, and then for 6 weeks after the quit date, followed by 14 mg/24 h for 2 weeks and 7 mg/24 h for 2 weeks. All treatment will terminate 10 weeks after the quit date.~Nicotine Patch: Pre-Quit Period: 2 weeks of patch use (21mg/24hr)~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)~Moclobemide: Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
689732|NCT01926119|B1|Baseline|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
689733|NCT01926119|P1|Participant Flow|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
689734|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
689735|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
689736|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
689737|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
689738|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
689739|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
689740|NCT01926119|O1|Outcome|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days.~Transcranial Magnetic Stimulation"
689741|NCT01926119|E1|Reported Event|TMS Intervention - 5 Days|"Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation~Transcranial Magnetic Stimulation"
689742|NCT01926015|B3|Baseline|Total|Total of all reporting groups
689743|NCT01926015|B2|Baseline|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689744|NCT01926015|B1|Baseline|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689745|NCT01926015|P2|Participant Flow|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689746|NCT01926015|P1|Participant Flow|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689747|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689748|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689749|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689750|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689751|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689752|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689753|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689754|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689755|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689756|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689757|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689758|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689759|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689760|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689761|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689762|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689763|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689764|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689765|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689766|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689767|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689768|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689769|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689770|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689771|NCT01926015|O2|Outcome|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689772|NCT01926015|O1|Outcome|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689773|NCT01926015|E2|Reported Event|Staggered RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) administered at Visit 1 (Day 1), Visit 3 (6-8 weeks after Visit 1), and Visit 5 (6-8 weeks after Visit 3) and DTP-IPV (0.5 mL subcutaneous injection) administered at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689774|NCT01926015|E1|Reported Event|Concomitant RotaTeq™ and DTP-IPV|RotaTeq™ (2 mL oral dose) and DTP-IPV (0.5 mL subcutaneous injection) administered concomitantly at Visit 2 (>=4 weeks after Visit 1), Visit 4 (6-8 weeks after Visit 2), and Visit 6 (6-8 weeks after Visit 4)
689775|NCT01925781|B3|Baseline|Total|Total of all reporting groups
689776|NCT01925781|B2|Baseline|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
689777|NCT01925781|B1|Baseline|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
689778|NCT01925781|P2|Participant Flow|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
689779|NCT01925781|P1|Participant Flow|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
689780|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
689781|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
689782|NCT01925781|O2|Outcome|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
689783|NCT01925781|O1|Outcome|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
689784|NCT01925781|E2|Reported Event|Nicotine Polacrilex|"Nicotine Replacement gum~Nicotine polacrilex: 2 mg and 4 mg gum will be used according to the FDA approved product labelling"
689785|NCT01925781|E1|Reported Event|e-Cigarette|STAM 1100mAh CE4 eGo Clearomizer e-Cigarette
689786|NCT01925768|B3|Baseline|Total|Total of all reporting groups
689787|NCT01925768|B2|Baseline|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
689788|NCT01925768|B1|Baseline|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
689789|NCT01925768|P2|Participant Flow|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
689790|NCT01925768|P1|Participant Flow|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
689791|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
689792|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
689793|NCT01925768|O2|Outcome|Apremilast (APR) 30 mg|Participants randomized to receive 30 mg apremilast (APR) tablets BID during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for EE, at the discretion of the investigator. Apremilast treated participants who EE continued to receive 30 mg apremilast BID in a blinded fashion.
689794|NCT01925768|O1|Outcome|Placebo (PBO)|Participants randomized to receive placebo tablets twice daily (BID) during the 24-week placebo-controlled phase. Participants whose improvement was less than 10% in both swollen and tender joint counts at Week 16 were eligible for early escape (EE), at the discretion of the investigator. Placebo-treated participants who early escaped were transitioned to apremilast 30 mg BID in a blinded fashion.
689795|NCT01925768|E2|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast BID during the 24 week placebo controlled period.
689796|NCT01925768|E1|Reported Event|Week 24: Placebo|Participants randomized to receive placebo tablets twice daily (BID) during the placebo-controlled phase. Includes data through week 16 for participants who early escaped and through week 24 for all other participants.
689797|NCT01925703|B1|Baseline|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
689798|NCT01925703|P1|Participant Flow|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
689799|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
690022|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
689800|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
689801|NCT01925703|O1|Outcome|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
689802|NCT01925703|E1|Reported Event|Sodium Ferric Gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
689803|NCT01925469|B3|Baseline|Total|Total of all reporting groups
689804|NCT01925469|B2|Baseline|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
689805|NCT01925469|B1|Baseline|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
689806|NCT01925469|P2|Participant Flow|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
689807|NCT01925469|P1|Participant Flow|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
689808|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
689809|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
689810|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
689811|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
689812|NCT01925469|O2|Outcome|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
689813|NCT01925469|O1|Outcome|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
689814|NCT01925469|E2|Reported Event|Saline Spray|"A saline placebo spray will be used in the placebo group.~Saline spray: A saline spray will be used in the placebo group"
689815|NCT01925469|E1|Reported Event|Benzocaine|"Benzocaine spray (14%), an FDA approved drug, will be used to assess whether this provides additional pain relief at time of hysterosalpingogram.~Benzocaine"
689816|NCT01925417|B1|Baseline|RBX2660 (Microbiota Suspension)|Open-label; all subjects received RBX2660
689817|NCT01925417|P1|Participant Flow|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
689818|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
689819|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
689820|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
689821|NCT01925417|O1|Outcome|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
689822|NCT01925417|E1|Reported Event|RBX2660 (Microbiota Suspension)|This was an open-label, non-randomized, non-controlled subjects. All treated subjects received RBX2660 (microbiota suspension).
689823|NCT01925274|B4|Baseline|Total|Total of all reporting groups
689824|NCT01925274|B3|Baseline|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689825|NCT01925274|B2|Baseline|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689826|NCT01925274|B1|Baseline|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689827|NCT01925274|P3|Participant Flow|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
690023|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690024|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
730086|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
689828|NCT01925274|P2|Participant Flow|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689829|NCT01925274|P1|Participant Flow|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689830|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689831|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689832|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689833|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689834|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689835|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689836|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689837|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689838|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689869|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689839|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689840|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689841|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689842|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689843|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689844|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689845|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689846|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689847|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689848|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689936|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
697557|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
689849|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689850|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689851|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689852|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689853|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689854|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689855|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689856|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689857|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689858|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689937|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
730087|NCT01694108|O2|Outcome|Control Children|No intervention
689859|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689860|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689861|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689862|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689863|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689864|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689865|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689866|NCT01925274|O2|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689867|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689868|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689938|NCT01925209|E4|Reported Event|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
697558|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
689870|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689871|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689872|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689873|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689874|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689875|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689876|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689877|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689878|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689879|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689880|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689939|NCT01925209|E3|Reported Event|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
691622|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
689881|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689882|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689883|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689884|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689885|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689886|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689887|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689888|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689889|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689890|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689891|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689892|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689893|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689894|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689895|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689896|NCT01925274|O3|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689897|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689898|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689899|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689900|NCT01925274|O2|Outcome|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689901|NCT01925274|O1|Outcome|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689902|NCT01925274|E3|Reported Event|PF-05212384 + Irinotecan: Japanese Lead-In Cohort (LIC)|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. Irinotecan was administered IV every other week (Days 1 and 15 of each 28 day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF 05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689903|NCT01925274|E2|Reported Event|Cetuximab + Irinotecan: Arm B|Cetuximab was administered IV every week (Days 1, 8, 15 and 22 of each 28-day cycle) at a starting dose level of 400 mg/m^2 on Cycle 1 Day 1 followed by 250 mg/m^2 in subsequent infusions. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of cetuximab and irinotecan were adjusted according to severity of toxicities.
689940|NCT01925209|E2|Reported Event|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689941|NCT01925209|E1|Reported Event|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689904|NCT01925274|E1|Reported Event|PF-05212384 + Irinotecan: Arm A|PF-05212384 was administered intravenously (IV) every week (Days 2, 9, 16 and 23 of each 28-day cycle) at a starting dose level of 110 mg. During Cycle 1, PF-05212384 was only dosed on Days 9, 16 and 23. After one cycle of dosing with PF-05212384, in subsequent cycles, the dose level remained at 110 mg or was escalated based on the occurrences of dose limiting toxicities (DLTs) in previous cycle and at the discretion of the investigator. Participants enrolled in Korea remained at the 110 mg starting dose level of PF-05212384. Irinotecan was administered IV every other week (Days 1 and 15 of each 28-day cycle) at a dose level of 180 mg/m^2. Both the dose levels of PF-05212384 and irinotecan were adjusted according to severity of toxicities. Infusion of PF-05212384 followed irinotecan infusion by at least 24 hours (+/- 10%).
689905|NCT01925209|B5|Baseline|Total|Total of all reporting groups
689906|NCT01925209|B4|Baseline|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689907|NCT01925209|B3|Baseline|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689908|NCT01925209|B2|Baseline|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689909|NCT01925209|B1|Baseline|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689910|NCT01925209|P4|Participant Flow|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689911|NCT01925209|P3|Participant Flow|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689912|NCT01925209|P2|Participant Flow|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689913|NCT01925209|P1|Participant Flow|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689914|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689915|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689916|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689917|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689918|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689919|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689920|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689921|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689922|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689923|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689924|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689925|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689926|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689927|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689928|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689929|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689930|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689931|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689932|NCT01925209|O2|Outcome|BYM338/Bimagrumab 3 mg/kg|Participants received study medication with BYM338 at 3 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689933|NCT01925209|O1|Outcome|BYM338/Bimagrumab 10 mg/kg|Participants received study medication with BYM338 at 10 mg/kg from Day 1 to Week 52 and up to Week 104, administered by intravenous (i.v.) infusion every 4 weeks.
689934|NCT01925209|O4|Outcome|Placebo|Participants received matching placebo to BYM338 from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689935|NCT01925209|O3|Outcome|BYM338/Bimagrumab 1 mg/kg|Participants received study medication with BYM338 at 1 mg/kg from Day 1 to Week 52 and up to Week 104, administered by i.v. infusion every 4 weeks.
689942|NCT01925183|B3|Baseline|Total|Total of all reporting groups
689943|NCT01925183|B2|Baseline|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689944|NCT01925183|B1|Baseline|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689945|NCT01925183|P2|Participant Flow|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689946|NCT01925183|P1|Participant Flow|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of pegylated interferon/ribavirin (PEGIFN/RBV) lead-in. Patients with undetectable hepatitis C virus (HCV)-RNA at treatment week 8 will be treated with 24 weeks of boceprevir (BOC)/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689947|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689948|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689949|NCT01925183|O2|Outcome|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689950|NCT01925183|O1|Outcome|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689951|NCT01925183|E2|Reported Event|48 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with detectable HCV-RNA at treatment week 8 will receive 44 weeks of BOC/PEGIFN/RBV triple-therapy and a total treatment duration of 48 weeks~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689952|NCT01925183|E1|Reported Event|28 Weeks of Treatment Duration|"All patients will receive 4 weeks of PEGIFN/RBV lead-in. Patients with undetectable HCV-RNA at treatment week 8 will be treated with 24 weeks of BOC/PEGIFN/RBV triple-therapy resulting in a total treatment duration of 28 weeks.~Pegylated interferon alpha-2a: 180mcg once weekly; subcutaneous injection~Ribavirin: 600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally~Boceprevir: 800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally"
689953|NCT01925170|B1|Baseline|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
690017|NCT01924767|P3|Participant Flow|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690018|NCT01924767|P2|Participant Flow|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
689954|NCT01925170|P1|Participant Flow|Mammography and Molecular Breast Imaging|"Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.~Molecular Breast Imaging: Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.~Conventional Mammography: Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.~Technetium (99mTc) sestamibi: Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands."
689955|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
689956|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
689957|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
689958|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
689959|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
689960|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
689961|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
689962|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
689963|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
689964|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
689965|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
689966|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
689967|NCT01925170|O3|Outcome|Molecular Breast Imaging Alone|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
689968|NCT01925170|O2|Outcome|Mammography With Adjunct MBI|For this reporting arm, the interpretation and analysis was done with both mammography and MBI together.
689969|NCT01925170|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
689970|NCT01925170|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
689971|NCT01925144|B1|Baseline|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
689972|NCT01925144|P1|Participant Flow|Baricitinib + Omeprazole|"10 milligram (mg) baricitinib tablet administered orally, once, on Day 1 in Period 1 and on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, once daily (QD), for 8 days (Days 3 through 10) in Period 2."
689973|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
689974|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
689975|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
689976|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
689977|NCT01925144|O2|Outcome|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally, once, on Day 10 in Period 2.~40 mg omeprazole capsule administered orally, QD, for 8 days (Days 3 through 10) in Period 2."
689978|NCT01925144|O1|Outcome|Baricitinib|10 mg baricitinib tablet administered orally, once, on Day 1 in Period 1.
689979|NCT01925144|E3|Reported Event|Baricitinib + Omeprazole|"10 mg baricitinib tablet administered orally once with 40 mg omeprazole capsule orally once, on Day 10 in Period 2.~Adverse events are reported from postdose on Day 10 up to Day 24."
689980|NCT01925144|E2|Reported Event|Omeprazole|"40 mg omeprazole capsule administered orally, QD, on Days 3 through 9 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 10."
689981|NCT01925144|E1|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally once, on Day 1 in Period 1.~Adverse events are reported from baseline through predose on Day 3."
689982|NCT01924975|B3|Baseline|Total|Total of all reporting groups
689983|NCT01924975|B2|Baseline|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
689984|NCT01924975|B1|Baseline|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
690019|NCT01924767|P1|Participant Flow|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
690020|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
691623|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
689985|NCT01924975|P2|Participant Flow|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
689986|NCT01924975|P1|Participant Flow|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
689987|NCT01924975|O2|Outcome|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
689988|NCT01924975|O1|Outcome|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
689989|NCT01924975|E2|Reported Event|Ultrasound Group|"An operator will identify the saphenous vein by using ultrasound with a linear transducer (L15-7io) in short axis view. A 22 or 24 G catheter will be advanced until the tip of the needle is seen on the ultrasound image. The needle is then advanced until blood appears in the hub. The catheter is then advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~ultrasound with a linear transducer (L15-7io): Portable, bed-side ultrasound to detect saphenous vein~A 22 or 24 G intravenous catheter"
689990|NCT01924975|E1|Reported Event|Landmark Group|"An operator is not allowed to use an ultrasound. A 22 or 24 G catheter will be advanced blindly toward the expected location of the saphenous vein at the level of the medial malleolus. Once blood appears in the hub, then the catheter will be advanced into the saphenous vein.~Saphenous vein cannulation: Intravenous cannulation to saphenous vein~A 22 or 24 G intravenous catheter"
689991|NCT01924949|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
689992|NCT01924949|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
689993|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
689994|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
689995|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
689996|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
689997|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
689998|NCT01924949|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
689999|NCT01924949|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
690000|NCT01924871|B3|Baseline|Total|Total of all reporting groups
690001|NCT01924871|B2|Baseline|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
690002|NCT01924871|B1|Baseline|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
690003|NCT01924871|P2|Participant Flow|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
690004|NCT01924871|P1|Participant Flow|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
690005|NCT01924871|O2|Outcome|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
690006|NCT01924871|O1|Outcome|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
690007|NCT01924871|E2|Reported Event|Desflurane With Remifentanil Group|"1.0 MAC desflurane with 1.0ng/ml targeted concentration infusion of remifentanil~Desflurane with remifentanil: During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil"
690008|NCT01924871|E1|Reported Event|Desflurane Group|"1.5 MAC desflurane until extubation~Desflurane: During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane"
690009|NCT01924767|B6|Baseline|Total|Total of all reporting groups
690010|NCT01924767|B5|Baseline|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
690011|NCT01924767|B4|Baseline|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
690012|NCT01924767|B3|Baseline|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
690013|NCT01924767|B2|Baseline|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
690014|NCT01924767|B1|Baseline|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690015|NCT01924767|P5|Participant Flow|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690016|NCT01924767|P4|Participant Flow|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690026|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690027|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690028|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690029|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily (qd) in the morning.
690030|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690031|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690032|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690033|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690034|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690035|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690036|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690037|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690038|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690039|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690040|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690041|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690042|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690043|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690044|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690045|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690046|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690047|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690048|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690049|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690050|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690051|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690052|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690053|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690054|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690055|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690056|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690057|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690058|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690059|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690060|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690061|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690062|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690063|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690064|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690065|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690066|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690067|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690068|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690069|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690070|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690071|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690072|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690073|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690074|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690075|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690076|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690077|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690078|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690079|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690080|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690081|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690082|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690083|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690084|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690085|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690086|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690087|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690088|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690089|NCT01924767|O4|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690090|NCT01924767|O3|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690091|NCT01924767|O2|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690092|NCT01924767|O1|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690093|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690094|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690095|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690096|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690097|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690098|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690099|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690100|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690101|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690102|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690103|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690104|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690105|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690106|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690107|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690108|NCT01924767|O5|Outcome|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily (qd) in the morning.
690109|NCT01924767|O4|Outcome|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily (qd) in the morning.
690110|NCT01924767|O3|Outcome|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily (qd) in the morning.
690111|NCT01924767|O2|Outcome|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily (qd) in the morning.
690112|NCT01924767|O1|Outcome|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690113|NCT01924767|E5|Reported Event|Empagliflozin 100 mg qd|Patients were treated with 100 mg Empagliflozin as tablet once daily in the morning.
690114|NCT01924767|E4|Reported Event|Empagliflozin 25 mg qd|Patients were treated with 25 mg Empagliflozin as tablet once daily in the morning.
690115|NCT01924767|E3|Reported Event|Empagliflozin 10 mg qd|Patients were treated with 10 mg Empagliflozin as tablet once daily in the morning.
690116|NCT01924767|E2|Reported Event|Empagliflozin 2.5 mg qd|Patients were treated with 2.5 mg Empagliflozin as tablet once daily in the morning.
690117|NCT01924767|E1|Reported Event|Placebo|Patients were treated with matching placebo as tablet once daily in the morning.
690118|NCT01924559|B1|Baseline|SALT and Biohazard Gear|All participants were tested on three intubation devices in either standard clothing or biohazard gear.
690119|NCT01924559|P1|Participant Flow|All Study Participants|All participants were randomized into groups testing three intubation devices while wearing standard clothing or biohazard gear..
730088|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
690120|NCT01924559|O6|Outcome|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT"
690121|NCT01924559|O5|Outcome|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
690122|NCT01924559|O4|Outcome|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~Glidescope"
690123|NCT01924559|O3|Outcome|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~Glidescope"
690124|NCT01924559|O2|Outcome|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
690125|NCT01924559|O1|Outcome|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
690126|NCT01924559|E6|Reported Event|SALT and Biohazard Gear|"Residents will intubate manikins using SALT while wearing biohazard gear.~Biohazard gear~SALT No adverse events"
690127|NCT01924559|E5|Reported Event|SALT & Standard Clothing|"Residents will intubate manikins using SALT while wearing standard clothing.~standard clothing~SALT"
690128|NCT01924559|E4|Reported Event|Glidescope & Biohazard Gear|"Residents will intubate manikins using Glidescope while wearing Biohazard gear.~Biohazard gear~GlideScope"
690129|NCT01924559|E3|Reported Event|Glidescope & Standard Clothing|"Residents will intubate manikins using Glidescope while wearing standard clothing.~standard clothing~GlideScope"
690130|NCT01924559|E2|Reported Event|DL & Biohazard Gear|"Residents will intubate manikins using DL while in Biohazard gear.~Biohazard gear~DL"
690131|NCT01924559|E1|Reported Event|DL & Standard Clothing|"Residents will intubate manikin using DL while wearing standard clothing.~standard clothing~DL"
690132|NCT01924390|B3|Baseline|Total|Total of all reporting groups
690133|NCT01924390|B2|Baseline|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
690134|NCT01924390|B1|Baseline|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
690135|NCT01924390|P2|Participant Flow|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
690136|NCT01924390|P1|Participant Flow|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
690137|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
690138|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
690139|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
690140|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
690141|NCT01924390|O2|Outcome|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
690142|NCT01924390|O1|Outcome|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
690143|NCT01924390|E2|Reported Event|Combination of Mineralized and Demineralized FDBA|"Socket grafting with a combination of mineralized and demineralized freeze-dried bone allograft alone~Combination of Mineralized and demineralized freeze-dried bone allograft alone"
690144|NCT01924390|E1|Reported Event|Mineralized FDBA Alone|"Socket grafting with mineralized freeze-dried bone allograft alone~Mineralized freeze-dried bone allograft alone"
690145|NCT01924299|B3|Baseline|Total|Total of all reporting groups
690146|NCT01924299|B2|Baseline|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.~400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
690147|NCT01924299|B1|Baseline|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.~400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2."
690148|NCT01924299|P2|Participant Flow|Baricitinib + Fluconazole (Group B)|"10 mg baricitinib administered orally once on Day 1 of Period 1 and on Day 7 of Period 2.~400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2."
690149|NCT01924299|P1|Participant Flow|Baricitinib + Ketoconazole (Group A)|"10 milligrams (mg) baricitinib administered orally once on Day 1 of Period 1 and on Day 6 of Period 2.~400 mg ketoconazole administered orally once daily (QD) for 6 days (Day 3 through Day 8) in Period 2."
690150|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
690151|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
690152|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
690153|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
690154|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
690155|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
697559|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
690511|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690156|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
690157|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
690158|NCT01924299|O2|Outcome|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD for 6 days (Day 4 through Day 9) in Period 2.
690159|NCT01924299|O1|Outcome|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1.
690160|NCT01924299|O2|Outcome|Baricitinib + Ketoconazole (Group A)|10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg Ketoconazole administered orally QD for 6 days (Day 3 through Day 8) in Period 2.
690161|NCT01924299|O1|Outcome|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1.
690162|NCT01924299|E6|Reported Event|Baricitinib + Fluconazole (Group B)|10 mg baricitinib administered orally once on Day 7 of Period 2. 200 mg fluconazole administered orally QD on Day 7 through Day 9 in Period 2. Adverse events are reported from postdose on Day 7 up to Day 23.
690163|NCT01924299|E5|Reported Event|Fluconazole (Group B)|"400 mg fluconazole administered orally once on Day 3 of Period 2, followed by 200 mg administered orally QD on Day 4 through Day 6 in Period 2.~Adverse events are reported from postdose on Day 3 through predose on Day 7."
690164|NCT01924299|E4|Reported Event|Baricitinib (Group B)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
690165|NCT01924299|E3|Reported Event|Baricitinib + Ketoconazole (Group A)|"10 mg baricitinib administered orally once on Day 6 of Period 2. 400 mg ketoconazole administered orally QD on Day 6 through Day 8 in Period 2.~Adverse events are reported from postdose on Day 6 up to Day 22."
690166|NCT01924299|E2|Reported Event|Ketoconazole (Group A)|400 mg ketoconazole administered orally QD on Day 3 through Day 5 in Period 2. Adverse events are reported from postdose on Day 3 through predose on Day 6.
690167|NCT01924299|E1|Reported Event|Baricitinib (Group A)|10 mg baricitinib administered orally once on Day 1 of Period 1. Adverse events are reported from baseline through predose on Day 3.
690168|NCT01924182|B3|Baseline|Total|Total of all reporting groups
690169|NCT01924182|B2|Baseline|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
690170|NCT01924182|B1|Baseline|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
690171|NCT01924182|P2|Participant Flow|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
690172|NCT01924182|P1|Participant Flow|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
690173|NCT01924182|O2|Outcome|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
690174|NCT01924182|O1|Outcome|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
690175|NCT01924182|E2|Reported Event|Conventional Medical Management|Subjects randomized to the CMM group will continue to use pain medications as prescribed by their doctor. Subjects randomized to CMM will be offered the option of pump implant following completion of the 3-month visit.
690176|NCT01924182|E1|Reported Event|IT Group (SynchroMed/Intrathecal Morphine Sulfate)|"Subjects randomized to the IT group (Intrathecal morphine sulfate/SynchroMed Infusion System) will have a test injection or infusion of intrathecal morphine to check for pain control and make sure there are no negative reactions. If the test is successful, subjects in the IT group will have a pump and spinal catheter implanted. These subjects will stop using all other pain medications and start using only intrathecal morphine for pain control.~SynchroMed Infusion System and Intrathecal Morphine Sulfate: Following a successful intrathecal test of morphine, IT morphine subjects will undergo surgery to implant the drug pump (SynchroMed) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control."
690177|NCT01923896|B3|Baseline|Total|Total of all reporting groups
690178|NCT01923896|B2|Baseline|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
690179|NCT01923896|B1|Baseline|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
690180|NCT01923896|P2|Participant Flow|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
690181|NCT01923896|P1|Participant Flow|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
690182|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
690183|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
690184|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
690185|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
690186|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
690187|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
690188|NCT01923896|O2|Outcome|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
690189|NCT01923896|O1|Outcome|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
690190|NCT01923896|E2|Reported Event|Behavioral Intervention & Placebo|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and placebo (lactose powder) by method of intake (bottle; formula; tube) to be taken acutely one hour prior to the onset of the first treatment session each day.
690191|NCT01923896|E1|Reported Event|Behavioral Intervention & DCS|Behavioral Feeding Intervention (15 total treatment sessions over 5 days) and D-cycloserine (0.7mg/kg DCS) to be taken acutely one hour prior to the onset of the first treatment session each day.
690192|NCT01923805|B3|Baseline|Total|Total of all reporting groups
690193|NCT01923805|B2|Baseline|Control|Standard of care for surgical hemostasis.
690194|NCT01923805|B1|Baseline|Treatment Group|"Vitagel~Vitagel: Vitagel"
690195|NCT01923805|P2|Participant Flow|Control|Standard of care for surgical hemostasis.
690196|NCT01923805|P1|Participant Flow|Treatment Group|"Vitagel~Vitagel: Vitagel"
690197|NCT01923805|O2|Outcome|Control|Standard of care for surgical hemostasis.
690198|NCT01923805|O1|Outcome|Treatment Group|"Vitagel~Vitagel: Vitagel"
690199|NCT01923805|E2|Reported Event|Control|Standard of care for surgical hemostasis.
690200|NCT01923805|E1|Reported Event|Treatment Group|"Vitagel~Vitagel: Vitagel"
690201|NCT01923480|B4|Baseline|Total|Total of all reporting groups
690202|NCT01923480|B3|Baseline|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
690203|NCT01923480|B2|Baseline|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
690204|NCT01923480|B1|Baseline|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
690205|NCT01923480|P6|Participant Flow|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690206|NCT01923480|P5|Participant Flow|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690207|NCT01923480|P4|Participant Flow|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690208|NCT01923480|P3|Participant Flow|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690465|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690209|NCT01923480|P2|Participant Flow|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690210|NCT01923480|P1|Participant Flow|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with insulin~15% CLINISOL- Sulfite-Free (Amino Acid) Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690211|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690212|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690213|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690214|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690215|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690216|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690217|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690218|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690219|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690220|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690221|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690222|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690223|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690224|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690225|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690226|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690227|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690228|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690500|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690229|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690230|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690231|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690232|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690233|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690234|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690235|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690236|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690237|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690238|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690239|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690240|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690241|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690242|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690243|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690244|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690245|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690246|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690247|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690248|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690501|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690249|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690250|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690251|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690252|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690253|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690254|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690255|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690256|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690257|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690258|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690259|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690260|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690261|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690262|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690263|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690264|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690265|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690266|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690267|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690268|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690502|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690269|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690270|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690271|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690272|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690273|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690274|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690275|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690276|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690277|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690278|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690279|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690280|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690281|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690282|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690283|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690284|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690285|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690286|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690287|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690288|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690503|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690289|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690290|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690291|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690292|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690293|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690294|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690295|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690296|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690297|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690298|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690299|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690300|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690301|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690302|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690303|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690304|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690305|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690306|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690307|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690308|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690504|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690309|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690310|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690311|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690312|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690313|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690314|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690315|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690316|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690317|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690318|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690319|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690320|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690321|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690322|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690323|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690324|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690325|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690326|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690327|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690328|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690505|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690329|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690330|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690331|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690332|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690333|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690334|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690335|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690336|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690337|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690338|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690339|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690340|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690341|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690342|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690343|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690344|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690345|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690346|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690347|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690348|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690506|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690349|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690350|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690351|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690352|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690353|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690354|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690355|NCT01923480|O6|Outcome|15% CLINISOL 0.13 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690356|NCT01923480|O5|Outcome|15% CLINISOL 0.13 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690357|NCT01923480|O4|Outcome|15% CLINISOL 0.08 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid)"
690358|NCT01923480|O3|Outcome|15% CLINISOL 0.08 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690359|NCT01923480|O2|Outcome|15% CLINISOL 0.04 g/kg/hr (BA)|"Sequence BA - with Insulin first, then no Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690360|NCT01923480|O1|Outcome|15% CLINISOL 0.04 g/kg/hr (AB)|"Sequence AB - without Insulin first, then with Insulin~15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection"
690361|NCT01923480|E3|Reported Event|15% CLINISOL 0.13 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.13 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
690362|NCT01923480|E2|Reported Event|15% CLINISOL 0.08 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.08 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
690363|NCT01923480|E1|Reported Event|15% CLINISOL 0.04 g/kg/hr|"15% CLINISOL- Sulfite-Free (Amino Acid)Injection 0.04 g/kg/hr to be administered. Each treatment session is expected to last 7 hours with the first 3 hours of basal infusion followed by 4 hours of 15% CLINISOL - Sulfite-Free (Amino Acid) Injection.~15% CLINISOL - Sulfite-free (Amino Acid) Injection"
690364|NCT01923467|B1|Baseline|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
690365|NCT01923467|P1|Participant Flow|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
690398|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690507|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690366|NCT01923467|O1|Outcome|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
690367|NCT01923467|E1|Reported Event|Project Quit Plus NRT Patches|"All participants in the program will be offered the opportunity to complete the Project Quit stop smoking program. Project Quit is an individually-tailored, web-based program which has been scientifically proven to help people succeed at their quit attempts. All eligible participants will also receive a 2-week supply of Nicotine patches 21 mg.~Project Quit stop smoking program: This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.~Nicotine patches 21 mg: Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt."
690368|NCT01923389|B3|Baseline|Total|Total of all reporting groups
690369|NCT01923389|B2|Baseline|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690370|NCT01923389|B1|Baseline|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690371|NCT01923389|P2|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690372|NCT01923389|P1|Participant Flow|Placebo|Placebo (normal saline) was administered as a 20-milliliters (mL) intravenous (IV) infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690373|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690374|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690375|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690376|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690377|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690378|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690379|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690380|NCT01923389|O1|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690381|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690382|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690383|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690384|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690385|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690386|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690387|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690388|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690389|NCT01923389|O2|Outcome|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690390|NCT01923389|O1|Outcome|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690391|NCT01923389|E2|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690392|NCT01923389|E1|Reported Event|Placebo|Placebo (normal saline) was administered as a 20-mL IV infusion twice weekly on Days 1, 4, 8, 11, 15, 18, 22 and 25.
690393|NCT01922986|B3|Baseline|Total|Total of all reporting groups
690394|NCT01922986|B2|Baseline|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690395|NCT01922986|B1|Baseline|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690396|NCT01922986|P2|Participant Flow|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690397|NCT01922986|P1|Participant Flow|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690508|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690399|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690400|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690401|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690402|NCT01922986|O2|Outcome|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690403|NCT01922986|O1|Outcome|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690404|NCT01922986|E2|Reported Event|Sham rTMS With Conventional Therapy|"20 minutes of sham rTMS stimulation followed by conventional stroke therapy~sham rTMS: 20 minutes of sham rTMS stimulation~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690405|NCT01922986|E1|Reported Event|Active rTMS With Conventional Therapy|"20 minutes of active rTMS followed by conventional stroke therapy~active rTMS: 10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).~conventional stroke therapy: conventional stroke therapy consisting of exercises and physical training"
690406|NCT01922739|B3|Baseline|Total|Total of all reporting groups
690407|NCT01922739|B2|Baseline|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690408|NCT01922739|B1|Baseline|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690409|NCT01922739|P1|Participant Flow|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
690410|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
690411|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
690412|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690413|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690414|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open label treatment period of 22 weeks.
690415|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered extended-release hydrocodone tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690509|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690416|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690417|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
690418|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690419|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690420|NCT01922739|O3|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both were followed by an open-label treatment period of 22 weeks.
690421|NCT01922739|O2|Outcome|Hydrocodone ER - Opioid Experienced|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690422|NCT01922739|O1|Outcome|Hydrocodone ER - Opioid Naive|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening in the C33237/3103 (NCT01789970) study.
690423|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
690424|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
690425|NCT01922739|O1|Outcome|Hydrocodone ER|Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. If enrolled under the original protocol, there was a double-blind titration period of four weeks to adjust the dose taken in study 3103 (NCT01789970). If enrolled under the amended protocol, there was an open-label adjustment period of three weeks to adjust the dose taken in study 3103 (NCT01789970). Both versions of protocol 3104 followed the titration/adjustment period with a open-label treatment period of 22 weeks.
690426|NCT01922739|O5|Outcome|Hydrocodone ER: Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Open-Label Treatment Period lasted 22 weeks.
690427|NCT01922739|O4|Outcome|Hydrocodone ER: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the amended protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
690428|NCT01922739|O3|Outcome|Placebo: Open-Label Adjustment Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the amended protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone ER every 12 hours titrated to an effective dosage over approximately 3 weeks."
690429|NCT01922739|O2|Outcome|Hydrocodone ER: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the original protocol, participants who received hydrocodone ER during the double-blind treatment period in Study 3103 took hydrocodone ER tablets and matching placebo every 12 hours titrated to an effective dosage over approximately 4 weeks."
690464|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690510|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690430|NCT01922739|O1|Outcome|Placebo: Double-Blind Titration Period|"Participants were administered hydrocodone ER tablets orally at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain.~As defined in the original protocol, participants who received placebo during the double-blind treatment period in Study 3103 took hydrocodone bitartrate ER tablets (and matching placebo) every 12 hours titrated to an effective dosage over approximately 4 weeks."
690431|NCT01922739|E2|Reported Event|Hydrocodone ER - Open-Label Treatment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful during the Titration/Adjustment period for managing their pain. The Treatment Period lasted 22 weeks.
690432|NCT01922739|E1|Reported Event|Hydrocodone ER - Titration/Adjustment Period|Participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours at the dosage deemed successful for managing their pain. The titration/adjustment period lasted 3-4 weeks.
690433|NCT01921296|B1|Baseline|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690434|NCT01921296|P1|Participant Flow|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690435|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690436|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690437|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690438|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690439|NCT01921296|O1|Outcome|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690440|NCT01921296|E1|Reported Event|Cyclobenzaprine|Cyclobenzaprine (Flexeril) 5 milligrams orally 2 hours before bed, for a total of 24 weeks.
690441|NCT01922349|B5|Baseline|Total|Total of all reporting groups
690442|NCT01922349|B4|Baseline|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690443|NCT01922349|B3|Baseline|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690444|NCT01922349|B2|Baseline|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690445|NCT01922349|B1|Baseline|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690446|NCT01922349|P4|Participant Flow|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690447|NCT01922349|P3|Participant Flow|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690448|NCT01922349|P2|Participant Flow|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690449|NCT01922349|P1|Participant Flow|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (Multiple rising dose (MRD) period)
690450|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690451|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690452|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690453|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690454|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690455|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690456|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690457|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690458|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690459|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690460|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690461|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690462|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690463|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690861|NCT01920802|E2|Reported Event|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690466|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690467|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690468|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690469|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690470|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690471|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690472|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690473|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690474|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690475|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690476|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690477|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690478|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690479|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690480|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690481|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690482|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690483|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690484|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690485|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690486|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690487|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690488|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690489|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 days in Chinese subjects (MRD period)
690490|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690491|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690492|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690493|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690494|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690495|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Caucasian subjects (MRD period)
690496|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Japanese subjects (MRD period)
690497|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration twice a day for 13 days plus a single dose on day 14 in Chinese subjects (MRD period)
690498|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690499|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
697560|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
690512|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690513|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690514|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690515|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690516|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690517|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690518|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690519|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690520|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690521|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690522|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690523|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690524|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690525|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690526|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690527|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690528|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690529|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690530|NCT01922349|O8|Outcome|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690531|NCT01922349|O7|Outcome|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690532|NCT01922349|O6|Outcome|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690533|NCT01922349|O5|Outcome|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690534|NCT01922349|O4|Outcome|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690535|NCT01922349|O3|Outcome|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 orally administered single dose in Caucasian subjects (SRD period)
690536|NCT01922349|O2|Outcome|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Japanese subjects (SRD period)
690537|NCT01922349|O1|Outcome|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 orally administered single dose in Chinese subjects (SRD period)
690538|NCT01922349|O4|Outcome|BI 113608 - 50 mg|2 conventional tablets 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690539|NCT01922349|O3|Outcome|BI 113608 - 25 mg|1 conventional tablet 25 mg BI 113608 oral administration, once daily (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690540|NCT01922349|O2|Outcome|BI 113608 - 10 mg|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690541|NCT01922349|O1|Outcome|Placebo|Matching placebo tablet: oral administration, single dose (single rising dose(SRD) period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period)
690542|NCT01922349|E11|Reported Event|BI 113608 - 50 mg - Caucasian|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
690543|NCT01922349|E10|Reported Event|BI 113608 - 50 mg - Japanese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
690544|NCT01922349|E9|Reported Event|BI 113608 - 50 mg - Chinese|2 conventional tablets 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
690545|NCT01922349|E8|Reported Event|BI 113608 - 25 mg - Japanese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
690546|NCT01922349|E7|Reported Event|BI 113608 - 25 mg - Chinese|1 conventional tablet 25 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
690547|NCT01922349|E6|Reported Event|BI 113608 - 10 mg - Caucasian|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
690548|NCT01922349|E5|Reported Event|BI 113608 - 10 mg - Japanese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
690625|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
690549|NCT01922349|E4|Reported Event|BI 113608 - 10 mg - Chinese|2 conventional tablets 5 mg BI 113608 oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 days (MRD period) in Chinese subjects
690550|NCT01922349|E3|Reported Event|Placebo- Caucasian|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Caucasian subjects
690551|NCT01922349|E2|Reported Event|Placebo- Japanese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Japanese subjects
690552|NCT01922349|E1|Reported Event|Placebo- Chinese|Matching placebo tablet: oral administration, single dose (SRD period) followed by twice a day for 13 days plus a single dose on day 14 (MRD period) in Chinese subjects
690553|NCT01922271|B3|Baseline|Total|Total of all reporting groups
690554|NCT01922271|B2|Baseline|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
690555|NCT01922271|B1|Baseline|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
690556|NCT01922271|P2|Participant Flow|Tiotropium Followed by NVA237|Period 1: tiotropium plus placebo to NVA237 on day 1, followed by a 7 day washout. Period 2: NVA237 plus placebo to tiotropium on day 8. Salbutamol was used as rescue medication.
690557|NCT01922271|P1|Participant Flow|NVA237 Followed by Tiotropium|Period 1: NVA237 plus placebo to tiotropium on day 1, followed by a 7 day washout. Period 2: tiotropium plus placebo to NVA237 on day 8. Salbutamol was used as rescue medication.
690558|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690559|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690560|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690561|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690562|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690563|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690564|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690565|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690566|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690567|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690568|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690569|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690570|NCT01922271|O2|Outcome|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690571|NCT01922271|O1|Outcome|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690572|NCT01922271|E2|Reported Event|Tiotropium|ALL patients onTiotropium for Period 1 & Period 2
690573|NCT01922271|E1|Reported Event|NVA237|ALL patients on NVA237 for Period 1 & Period 2
690574|NCT01922219|B1|Baseline|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
690575|NCT01922219|P1|Participant Flow|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
690576|NCT01922219|O1|Outcome|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
690577|NCT01922219|E1|Reported Event|Cognitive Behavioral Therapy|"Depressed individuals who enroll in this study will receive 14 sessions of cognitive behavioral therapy provided by an experienced psychiatrist or psychologist over 12 weeks (twice-a-week for the first two weeks, and weekly after that).~Cognitive Behavioral Therapy: 14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks"
690578|NCT01922115|B3|Baseline|Total|Total of all reporting groups
690579|NCT01922115|B2|Baseline|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
690580|NCT01922115|B1|Baseline|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
690581|NCT01922115|P2|Participant Flow|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
690582|NCT01922115|P1|Participant Flow|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
690583|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
690584|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
690585|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
690586|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
690587|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
690588|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
690589|NCT01922115|O2|Outcome|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
690590|NCT01922115|O1|Outcome|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
690591|NCT01922115|E2|Reported Event|PLACEBO|"Subjects may be administered a placebo rather than the Sanctura XR (Trospium Chloride).~Placebo"
690592|NCT01922115|E1|Reported Event|TROSPIUM CHLORIDE|"Those with overactive bladder will be administered either a placebo or Sanctura XR extended release (Trospium chloride) for treatment (60 mg).~Trospium Chloride: Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit."
690593|NCT01922089|B3|Baseline|Total|Total of all reporting groups
690594|NCT01922089|B2|Baseline|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
690595|NCT01922089|B1|Baseline|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
690596|NCT01922089|P2|Participant Flow|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
690597|NCT01922089|P1|Participant Flow|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
690598|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
690599|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
690600|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
690601|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
690602|NCT01922089|O2|Outcome|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
690603|NCT01922089|O1|Outcome|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
690604|NCT01922089|E2|Reported Event|LCZ696 Conservative|Up-titration to LCZ696 200 mg bid over 6 weeks
690605|NCT01922089|E1|Reported Event|LCZ696 Condensed|Up-titration to LCZ696 200 mg twice daily (bid) over 3 weeks
690606|NCT01921894|B4|Baseline|Total|Total of all reporting groups
690607|NCT01921894|B3|Baseline|Cholecalciferol 200 IU|Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks
690608|NCT01921894|B2|Baseline|Cholecalciferol 2000 IU|Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks
690609|NCT01921894|B1|Baseline|Cholecalciferol 4000 IU|Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks
690610|NCT01921894|P3|Participant Flow|Cholecalciferol 200 IU|"Cholecalciferol 200 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
690611|NCT01921894|P2|Participant Flow|Cholecalciferol 2000 IU|"Cholecalciferol 2000 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
690612|NCT01921894|P1|Participant Flow|Cholecalciferol 4000 IU|"Cholecalciferol 4000 IU oral chewable tablet once daily for 8 weeks~Cholecalciferol: vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day."
690613|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
690614|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
690615|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 4 weeks.
690616|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
690617|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
690618|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined having FEV1 < 80% of predicted
690619|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
690620|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
690621|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having urinary calcium/creatinine ratio > 0.37
690622|NCT01921894|O3|Outcome|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
690623|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
690624|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D toxicity, hypercalcemia (>10.8 mg/dl) or elevated uCa/uCr (>0.37).
690626|NCT01921894|O2|Outcome|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
690627|NCT01921894|O1|Outcome|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome was defined as having vitamin D ≥30 ng/ml after 8 weeks.
690628|NCT01921894|E3|Reported Event|Cholecalciferol 200 IU|All participants randomized to 200 IU per day were analyzed. Outcome includes any report of adverse events.
690629|NCT01921894|E2|Reported Event|Cholecalciferol 2000 IU|All participants randomized to 2000 IU per day were analyzed. Outcome includes any report of adverse events.
690630|NCT01921894|E1|Reported Event|Cholecalciferol 4000 IU|All participants randomized to 4000 IU per day were analyzed. Outcome includes any report of adverse events.
690631|NCT01921452|B1|Baseline|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
690632|NCT01921452|P1|Participant Flow|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant's fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
690633|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
690634|NCT01921452|O1|Outcome|POC TSH Kits + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
690635|NCT01921452|E1|Reported Event|POC TSH Kit + Third Generation TSH Kit|Participants were analyzed using the following methods on Day 1 to Day 5: (1) POC TSH kits: A drop (approximately 30 microliter [mcL]) of blood was taken from participant’s fingertip to test TSH quantitatively and qualitatively by using the quantitative POC TSH test kit and qualitative POC TSH test kit, respectively according to the respective product specifications. (2) Third generation TSH kit: 1 milliliter (mL) of participant's venous blood was taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit.
690636|NCT01921101|B3|Baseline|Total|Total of all reporting groups
690637|NCT01921101|B2|Baseline|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
690638|NCT01921101|B1|Baseline|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
690639|NCT01921101|P2|Participant Flow|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
690640|NCT01921101|P1|Participant Flow|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
690641|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
690642|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
690643|NCT01921101|O2|Outcome|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
690644|NCT01921101|O1|Outcome|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
690645|NCT01921101|E2|Reported Event|Control|"participants will not receive intensive nutritional support from hospital admission to discharge~control: participants will receive standard care for nutrition received from hospital admission to discharge"
690646|NCT01921101|E1|Reported Event|Intensive Medical Nutrition|"participants will receive intensive medical nutrition from hospital admission to discharge~intensive medical nutrition: provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge"
690647|NCT01920958|B1|Baseline|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690862|NCT01920802|E1|Reported Event|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690648|NCT01920958|P1|Participant Flow|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690649|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690650|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690651|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690652|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690653|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690654|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690655|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690656|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690657|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690658|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690659|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690660|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690661|NCT01920958|O1|Outcome|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690662|NCT01920958|E1|Reported Event|TachoSil®|TachoSil®, sterile absorbable patch, topical application, applied during surgery in participants who had lymph node surgery according to the Summary of Product Characteristics.
690663|NCT01920893|B3|Baseline|Total|Total of all reporting groups
690664|NCT01920893|B2|Baseline|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690665|NCT01920893|B1|Baseline|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690666|NCT01920893|P2|Participant Flow|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690667|NCT01920893|P1|Participant Flow|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection every week (QW) from Week 1 to 15 added to MFNS.
690668|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690669|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690670|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690671|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690672|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection every week from Week 1 to 15 added to MFNS.
690673|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690674|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690675|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690676|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690677|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690678|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690679|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690680|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690681|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690863|NCT01920568|B3|Baseline|Total|Total of all reporting groups
690682|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690683|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690684|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690685|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690686|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690687|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690688|NCT01920893|O2|Outcome|Dupilumab 300 mg QW|Dupilumab, 2 subcutaneous injections on Day 1 as a loading dose for a total of 600 mg, followed by a single 300 mg injection QW from Week 1 to 15 added to MFNS.
690689|NCT01920893|O1|Outcome|Placebo|Placebo (for dupilumab), 2 subcutaneous injections on Day 1 as a loading dose followed by a single injection QW from Week 1 to 15 added to MFNS.
690690|NCT01920893|E2|Reported Event|Dupilumab 300 mg QW|Participants exposed to dupilumab added to MFNS (mean exposure of 16 weeks).
690691|NCT01920893|E1|Reported Event|Placebo|Participants exposed to placebo (for dupilumab) added to MFNS (mean exposure of 14 weeks).
690692|NCT01920854|B8|Baseline|Total|Total of all reporting groups
690693|NCT01920854|B7|Baseline|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690694|NCT01920854|B6|Baseline|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690695|NCT01920854|B5|Baseline|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690696|NCT01920854|B4|Baseline|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690697|NCT01920854|B3|Baseline|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690698|NCT01920854|B2|Baseline|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690699|NCT01920854|B1|Baseline|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
690700|NCT01920854|P7|Participant Flow|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690701|NCT01920854|P6|Participant Flow|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690702|NCT01920854|P5|Participant Flow|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690703|NCT01920854|P4|Participant Flow|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690704|NCT01920854|P3|Participant Flow|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690705|NCT01920854|P2|Participant Flow|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
691018|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691020|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
694932|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
690706|NCT01920854|P1|Participant Flow|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
690707|NCT01920854|O7|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690708|NCT01920854|O6|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690709|NCT01920854|O5|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690710|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690711|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690712|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690713|NCT01920854|O1|Outcome|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
690714|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690715|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690716|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690717|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690718|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690719|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690720|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690721|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690722|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690723|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690724|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690725|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690726|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690727|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690728|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690729|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690730|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690731|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690732|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690733|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690734|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690735|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690736|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690737|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690738|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690739|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690740|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690741|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690742|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690743|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
691019|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
690744|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
690745|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
690746|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690747|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690748|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690749|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690750|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690751|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690752|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
690753|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
690754|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690755|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690756|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690757|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690758|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690759|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690760|NCT01920854|O6|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690761|NCT01920854|O5|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690762|NCT01920854|O4|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
730089|NCT01694108|O2|Outcome|Control Children|No intervention
690763|NCT01920854|O3|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690764|NCT01920854|O2|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690765|NCT01920854|O1|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690766|NCT01920854|O8|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690767|NCT01920854|O7|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690768|NCT01920854|O6|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690769|NCT01920854|O5|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690770|NCT01920854|O4|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690771|NCT01920854|O3|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690772|NCT01920854|O2|Outcome|Cohorts 4, 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4, 5 Placebo received IV D5W infused over 12 hours.
690773|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 -3, 6 Placebo received IV D5W infused over 4 hours.
690774|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690775|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690776|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
690777|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690778|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690779|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690780|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690781|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
730090|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
690782|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690783|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690784|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
690785|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690786|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690787|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690788|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690789|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
690790|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690791|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690792|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
690793|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690794|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690795|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690796|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690797|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
690798|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690799|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690800|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
730091|NCT01694108|O2|Outcome|Control Children|No intervention
690801|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690802|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690803|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690804|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690805|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
690806|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690807|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690808|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
690809|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690810|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690811|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690812|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690813|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
690814|NCT01920854|O3|Outcome|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690815|NCT01920854|O2|Outcome|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690816|NCT01920854|O1|Outcome|Cohorts 4 and 5 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 4 and 5 Placebo received IV D5W infused over 12 hours.
690817|NCT01920854|O5|Outcome|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690818|NCT01920854|O4|Outcome|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690819|NCT01920854|O3|Outcome|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
730092|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
690820|NCT01920854|O2|Outcome|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690821|NCT01920854|O1|Outcome|Cohorts 1 - 3, 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 3, 6 Placebo received IV D5W infused over 4 hours.
690822|NCT01920854|E7|Reported Event|Cohort 6 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 6 SFP received 10 mg IV SFP infused over 4 hours.
690823|NCT01920854|E6|Reported Event|Cohort 5 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 5 SFP received 20 mg IV SFP infused over 12 hours.
690824|NCT01920854|E5|Reported Event|Cohort 4 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 4 SFP received 15 mg IV SFP infused over 12 hours.
690825|NCT01920854|E4|Reported Event|Cohort 3 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 3 SFP received 7.5 mg IV SFP infused over 4 hours.
690826|NCT01920854|E3|Reported Event|Cohort 2 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 2 SFP received 5.0 mg IV SFP infused over 4 hours.
690827|NCT01920854|E2|Reported Event|Cohort 1 SFP|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohort 1 SFP received 2.5 mg IV SFP infused over 4 hours.
690828|NCT01920854|E1|Reported Event|Cohorts 1 - 6 Placebo|A total of 48 subjects were studied in 6 sequential cohorts (8 subjects per group, randomized as 6 active and 2 placebo). Cohorts 1, 2, 3, and 6 received ascending doses of test article over 4-hour infusions. Cohorts 4 and 5 received ascending doses of test article over 12-hour infusions. Cohorts 1 - 6 Placebo received IV D5W infused over either 4 hours (Cohorts 1, 2, 3, 6) or 12 hours (Cohorts 4, 5).
690829|NCT01920802|B4|Baseline|Total|Total of all reporting groups
690830|NCT01920802|B3|Baseline|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690831|NCT01920802|B2|Baseline|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690832|NCT01920802|B1|Baseline|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690833|NCT01920802|P3|Participant Flow|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690834|NCT01920802|P2|Participant Flow|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690835|NCT01920802|P1|Participant Flow|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690836|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690837|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690838|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690839|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690840|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690841|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690842|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690843|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690844|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690845|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690846|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690847|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690848|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690849|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690850|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690851|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690852|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690853|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690854|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690855|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690856|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690857|NCT01920802|O3|Outcome|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690858|NCT01920802|O2|Outcome|Iloperidone|"6mg BID iloperidone up to 4 weeks~iloperidone: 6 mg BID up to 4 weeks"
690859|NCT01920802|O1|Outcome|Olanzapine|"5mg BID olanzapine for up to 4 weeks~olanzapine: 5mg BID up to 4 weeks"
690860|NCT01920802|E3|Reported Event|Placebo|"BID placebo up to 4 weeks~Placebo: BID up to 4 weeks"
690864|NCT01920568|B2|Baseline|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690865|NCT01920568|B1|Baseline|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690866|NCT01920568|P2|Participant Flow|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690867|NCT01920568|P1|Participant Flow|Denosumab 120 mg|Participants received denosumab 120 milligrams (mg) as subcutaneous (SC) injection for a maximum of 13 doses and placebo as intravenous (IV) infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 international unit (IU) of vitamin D.
690868|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690869|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690870|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690871|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690872|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690873|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690874|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690875|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690876|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690877|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690878|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690879|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690880|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690881|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690882|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690883|NCT01920568|O2|Outcome|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690884|NCT01920568|O1|Outcome|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks up to 49 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690885|NCT01920568|E2|Reported Event|Zoledronic Acid 4 mg|Participants received zoledronic acid 4 mg as IV infusion over a minimum of 15 minutes for a maximum of 13 doses and placebo as SC once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
730093|NCT01694108|O2|Outcome|Control Children|No intervention
690886|NCT01920568|E1|Reported Event|Denosumab 120 mg|Participants received denosumab 120 mg as SC injection for a maximum of 13 doses and placebo as IV infusion over a minimum of 15 minutes once every 4 weeks. Participants also received daily oral supplementation of >= 500 mg elemental calcium and >=400 IU of vitamin D.
690887|NCT01920282|B4|Baseline|Total|Total of all reporting groups
690888|NCT01920282|B3|Baseline|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
690889|NCT01920282|B2|Baseline|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
690890|NCT01920282|B1|Baseline|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
690891|NCT01920282|P3|Participant Flow|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
690892|NCT01920282|P2|Participant Flow|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
690893|NCT01920282|P1|Participant Flow|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
690894|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
690895|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
690896|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
690913|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690914|NCT01920178|E2|Reported Event|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690897|NCT01920282|O3|Outcome|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
690898|NCT01920282|O2|Outcome|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
690899|NCT01920282|O1|Outcome|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
690900|NCT01920282|E3|Reported Event|Nebivolol Plus Lifestyle Modification|"Subjects began with 5 mg/day of nebivolol and increased to 10 mg/day if brachial blood pressure was greater than 120/80 mmHg during the first two weeks of therapy. Subjects also received weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approaches to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Nebivolol plus Lifestyle Modification"
690901|NCT01920282|E2|Reported Event|Lifestyle Modification|"Subjects will receive weekly lifestyle counseling by a registered dietitian to ensure adequate progress and compliance. Sample menus, 14-days of meal plans, and grocery shopping lists were provided to each individual. Individuals were instructed to reduce their daily caloric intake by 500-1000 calories and to perform a minimum of 150 minutes per week of moderate-intensity physical activity or 3000 steps/day above baseline levels. The diet plan conformed to the Dietary Approach to Stop Hypertension dietary guidelines emphasizing low fat dairy products, fruits and vegetable and contained 55% calories as carbohydrates, 30% calories as fat, and 15% calories as protein21. Sodium consumption was set at 2,400 mg/day for all subjects.~Lifestyle Modification"
690902|NCT01920282|E1|Reported Event|Nebivolol|"Subjects will be provided with daily 5 mg of nebivolol for the first 2 weeks. Subjects receive additional daily doses of 10 mg nebivolol for the remainder of the study period. The dose remains at 5 mg per day, however, if BP falls below 110/70 during the first 2 weeks. Subjects will continue taking the drug during the 2-week follow-up period.~Nebivolol"
690903|NCT01920178|B3|Baseline|Total|Total of all reporting groups
690904|NCT01920178|B2|Baseline|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690905|NCT01920178|B1|Baseline|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690906|NCT01920178|P2|Participant Flow|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690907|NCT01920178|P1|Participant Flow|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690908|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690909|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690910|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690911|NCT01920178|O1|Outcome|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690912|NCT01920178|O2|Outcome|Sham Laser Group|"Treatment with only localizing (aiming) beam of Pinpointe Foot Laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690951|NCT01919723|B1|Baseline|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~Ticagrelor: Ticagrelor loading dose~Eptifibatide: i.v. infusion"
690915|NCT01920178|E1|Reported Event|PinPointe Foot Laser|"Active laser~PinPointe Foot Laser: Active Laser Treatment Group will receive active Pinpointe Foot Laser beam.~Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser"
690916|NCT01919996|B1|Baseline|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
690917|NCT01919996|P1|Participant Flow|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
690918|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
690919|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
690920|NCT01919996|O1|Outcome|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
690921|NCT01919996|E1|Reported Event|Azithromycin|All participants had received open-label azithromycin oral suspension immediate release (12 mg/kg/day, up to a maximum daily dose of 500 mg) on Days 1, 2, 3, 4, and 5.
690922|NCT01919801|B3|Baseline|Total|Total of all reporting groups
690923|NCT01919801|B2|Baseline|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690924|NCT01919801|B1|Baseline|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690925|NCT01919801|P2|Participant Flow|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690926|NCT01919801|P1|Participant Flow|Icatibant 30 mg|Participants received a single dose of icatibant 30 milligram (mg) subcutaneous (SC) injection within 12 hours after the onset of the angiotensin-converting enzyme inhibitor (ACE-I) induced angioedema attack.
690927|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690928|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690929|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690930|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690931|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690932|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690933|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690934|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690935|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690936|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690937|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690938|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690939|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690940|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690941|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690942|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690943|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690944|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690945|NCT01919801|O2|Outcome|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690946|NCT01919801|O1|Outcome|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690947|NCT01919801|E2|Reported Event|Placebo|Participants received a single dose of placebo matched to icatibant SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690948|NCT01919801|E1|Reported Event|Icatibant 30 mg|Participants received a single dose of icatibant 30 mg SC injection within 12 hours after the onset of the ACE-I induced angioedema attack.
690949|NCT01919723|B3|Baseline|Total|Total of all reporting groups
690950|NCT01919723|B2|Baseline|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~Ticagrelor: Ticagrelor loading dose~Eptifibatide: i.v. infusion"
690952|NCT01919723|P2|Participant Flow|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690953|NCT01919723|P1|Participant Flow|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690954|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690955|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690956|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690957|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690958|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690959|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690960|NCT01919723|O2|Outcome|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690961|NCT01919723|O1|Outcome|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690962|NCT01919723|E2|Reported Event|Ticagrelor & Eptifibatide Bolus+Infusion|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg, 10 min apart, followed by 2µg/Kg/min infusion for 2 hours)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690963|NCT01919723|E1|Reported Event|Ticagrelor and Eptifibatide Bolus|"Ticagrelor 180 mg i.v. Eptifibatide (2 boluses 180µg/Kg each 10 min apart)~ticagrelor: ticagrelor loading dose~Eptifibatide: i.v. infusion"
690964|NCT01919606|B3|Baseline|Total|Total of all reporting groups
690965|NCT01919606|B2|Baseline|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690966|NCT01919606|B1|Baseline|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690967|NCT01919606|P2|Participant Flow|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690968|NCT01919606|P1|Participant Flow|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690969|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690970|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690971|NCT01919606|O2|Outcome|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690972|NCT01919606|O1|Outcome|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690973|NCT01919606|E2|Reported Event|EXPAREL Group 2|"EXPAREL 266 mg diluted with saline to a volume of 60 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690974|NCT01919606|E1|Reported Event|EXPAREL Group 1|"EXPAREL 266 mg diluted with saline to a volume of 40 mL~EXPAREL: Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively."
690975|NCT01919450|B5|Baseline|Total|Total of all reporting groups
690976|NCT01919450|B4|Baseline|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690977|NCT01919450|B3|Baseline|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690978|NCT01919450|B2|Baseline|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690979|NCT01919450|B1|Baseline|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690980|NCT01919450|P4|Participant Flow|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
691017|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
697561|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
690981|NCT01919450|P3|Participant Flow|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690982|NCT01919450|P2|Participant Flow|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690983|NCT01919450|P1|Participant Flow|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690984|NCT01919450|O1|Outcome|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690985|NCT01919450|O1|Outcome|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690986|NCT01919450|O1|Outcome|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690987|NCT01919450|O1|Outcome|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690988|NCT01919450|E4|Reported Event|1 Minute Delay|"A 1 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690989|NCT01919450|E3|Reported Event|4 Minute Delay|"A 4 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690990|NCT01919450|E2|Reported Event|2 Minute Delay|"A 2 minute delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690991|NCT01919450|E1|Reported Event|10 Second Delay|"A 10 second delay is imposed between the Lexiscan (Regadenoson) injection and start of myocardial perfusion PET imaging.~Regadenoson: Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.~Rubidium-82: Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study."
690992|NCT01919229|B4|Baseline|Total|Total of all reporting groups
690993|NCT01919229|B3|Baseline|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
690994|NCT01919229|B2|Baseline|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
690995|NCT01919229|B1|Baseline|Letrozole|Letrozole 2.5 mg alone once daily
690996|NCT01919229|P3|Participant Flow|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
690997|NCT01919229|P2|Participant Flow|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
690998|NCT01919229|P1|Participant Flow|Letrozole|Letrozole 2.5 mg alone once daily
690999|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
691000|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691001|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
691002|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
691003|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691004|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
691005|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
691006|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691007|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
691008|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
691009|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691010|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
691011|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
691012|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691013|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
691014|NCT01919229|O3|Outcome|LEE011 600mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
691015|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691016|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
691021|NCT01919229|O2|Outcome|LEE011 400mg + Letrozole|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691022|NCT01919229|O1|Outcome|Letrozole|Letrozole 2.5 mg alone once daily
691023|NCT01919229|E3|Reported Event|LEE600mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 600 mg (3 capsules of 200 mg each) once daily.
691024|NCT01919229|E2|Reported Event|LEE400mgqd+Letrozole2.5mgqd|Letrozole 2.5 mg once daily and ribociclib 400 mg (2 capsules of 200 mg each) once daily.
691025|NCT01919229|E1|Reported Event|Letrozole2.5mgqd|Letrozole 2.5 mg alone once daily
691026|NCT01918800|B3|Baseline|Total|Total of all reporting groups
691027|NCT01918800|B2|Baseline|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691028|NCT01918800|B1|Baseline|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691029|NCT01918800|P2|Participant Flow|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691030|NCT01918800|P1|Participant Flow|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691031|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691032|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691033|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691034|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691035|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691036|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691037|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691038|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691039|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691040|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691041|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691042|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691043|NCT01918800|O2|Outcome|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691044|NCT01918800|O1|Outcome|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691045|NCT01918800|E2|Reported Event|MS: Take Control|"MS: Take Control includes topics of interest to people with MS other than fatigue.~MS: Take Control: MS: Take Control includes topics of interest to people with MS other than fatigue."
691046|NCT01918800|E1|Reported Event|Fatigue: Take Control|"Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline~Fatigue: Take control: Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline"
691047|NCT01918371|B3|Baseline|Total|Total of all reporting groups
691048|NCT01918371|B2|Baseline|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691049|NCT01918371|B1|Baseline|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691050|NCT01918371|P2|Participant Flow|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691051|NCT01918371|P1|Participant Flow|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691179|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691052|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691053|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691054|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691055|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691056|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691057|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691058|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691059|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691060|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691061|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691062|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691063|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691064|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691065|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691066|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691067|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691068|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691069|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691070|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691071|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691072|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691073|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691074|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691075|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691076|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691077|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691078|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691176|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691079|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691080|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691081|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691082|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691083|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691084|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691085|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691086|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691087|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691088|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691089|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691090|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691091|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691092|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691093|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691094|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691095|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691096|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691097|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691098|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691099|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691100|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691101|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691102|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691103|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691104|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691105|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691177|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
700401|NCT01853072|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
691106|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691107|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691108|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691109|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691110|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691111|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691112|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691113|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691114|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691115|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691116|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691117|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691118|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691119|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691120|NCT01918371|O2|Outcome|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691121|NCT01918371|O1|Outcome|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691122|NCT01918371|E2|Reported Event|Patients With DME|Patients with diabetic macular edema (DME) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691123|NCT01918371|E1|Reported Event|Patients With RVO|Patients with retinal vein occlusion (RVO) receiving anti-VEGF injection(s) (ranibizumab, bevacizumab or aflibercept) in accordance with standard of care practices. This is a retrospective chart review study.
691124|NCT01918332|B5|Baseline|Total|Total of all reporting groups
691125|NCT01918332|B4|Baseline|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
691126|NCT01918332|B3|Baseline|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
691127|NCT01918332|B2|Baseline|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
691128|NCT01918332|B1|Baseline|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
691129|NCT01918332|P4|Participant Flow|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
691130|NCT01918332|P3|Participant Flow|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
691131|NCT01918332|P2|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
691132|NCT01918332|P1|Participant Flow|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
691133|NCT01918332|O2|Outcome|V160 & Placebo|Valsartan 160mg + Rosuvastatin 20mg placebo & Placebo
691134|NCT01918332|O1|Outcome|V160+R20 & R20|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg placebo + Rosuvastatin 20mg
691135|NCT01918332|O2|Outcome|R20 & Placebo|Valsartan 160mg placebo + Rosuvastatin 20mg & Placebo
691136|NCT01918332|O1|Outcome|V160+R20 & V160|Valsartan 160mg + Rosuvastatin 20mg & Valsartan 160mg + Rosuvastatin 20mg placebo
700402|NCT01853072|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
691137|NCT01918332|E4|Reported Event|Placebo|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg placebo~Rosuvastatin 20mg placebo"
691138|NCT01918332|E3|Reported Event|Valsartan 160mg Placebo, Rosuvastatin 20mg|"Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks.~Rosuvastatin 20mg~Valsartan 160mg placebo"
691139|NCT01918332|E2|Reported Event|Valsartan 160mg, Rosuvastatin 20mg Placebo|"Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg placebo"
691140|NCT01918332|E1|Reported Event|Valsartan 160mg, Rosuvastatin 20mg|"Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks.~Valsartan 160mg~Rosuvastatin 20mg"
691141|NCT01918085|B3|Baseline|Total|Total of all reporting groups
691142|NCT01918085|B2|Baseline|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
691143|NCT01918085|B1|Baseline|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
691144|NCT01918085|P2|Participant Flow|First Peristomal Skin, Then Pre-stripped Abdomianl Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
691145|NCT01918085|P1|Participant Flow|First Pre-stripped Abdominal Skin, Then Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
691146|NCT01918085|O4|Outcome|Peristomal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
691147|NCT01918085|O3|Outcome|Pre-stripped Abdominal Skin - Hydrocolloid Adhesive|"The peel force used to remove a hydrocolloid strip from the Peristomal skin~hydrocolloid strip : An adhesive strip made of the hydrocolloid adhesive"
691148|NCT01918085|O2|Outcome|Pre-stripped Abdominal Skin -Strata Adhesive|"The peel force used to remove a strata strip from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive"
691149|NCT01918085|O1|Outcome|Peristomal Skin- Strata Adhesive|"The peel force used to remove a strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive"
691150|NCT01918085|E2|Reported Event|Peristomal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from the Peristomal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
691151|NCT01918085|E1|Reported Event|Pre-stripped Abdominal Skin|"The peel force used to remove two types of adhesive strips (Hydrocolloid strip and strata strip) from healthy abdominal skin~Strata strip : An adhesive strip made of the Strata adhesive~Hydrocolloid strip : An adhesive strip made of hydrocolloid adhesive"
691152|NCT01918033|B4|Baseline|Total|Total of all reporting groups
691153|NCT01918033|B3|Baseline|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691154|NCT01918033|B2|Baseline|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691155|NCT01918033|B1|Baseline|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691156|NCT01918033|P3|Participant Flow|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691157|NCT01918033|P2|Participant Flow|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691158|NCT01918033|P1|Participant Flow|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691159|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691160|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691161|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691162|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691163|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691164|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691165|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691166|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691167|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691168|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691169|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691170|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691171|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691172|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691173|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691174|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691175|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691180|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691181|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691182|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691183|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691184|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691185|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691186|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691187|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691188|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691189|NCT01918033|O3|Outcome|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691190|NCT01918033|O2|Outcome|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691191|NCT01918033|O1|Outcome|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691192|NCT01918033|E3|Reported Event|Placebo|Participants receive two placebo tablets orally once daily for up to 2 weeks
691193|NCT01918033|E2|Reported Event|Desloratadine 10 mg|Participants receive two desloratadine 5 mg tablets orally once daily for up to 2 weeks
691194|NCT01918033|E1|Reported Event|Desloratadine 5 mg|Participants receive one desloratadine 5 mg tablet and one placebo tablet orally once daily for up to 2 weeks
691195|NCT01917812|B4|Baseline|Total|Total of all reporting groups
691196|NCT01917812|B3|Baseline|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
691197|NCT01917812|B2|Baseline|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
691198|NCT01917812|B1|Baseline|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
691199|NCT01917812|P3|Participant Flow|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
691200|NCT01917812|P2|Participant Flow|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~No Smart Text Messaging = Group does not receive personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker"
691201|NCT01917812|P1|Participant Flow|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
691202|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
691203|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
691204|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
691205|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
691206|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
691207|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
691208|NCT01917812|O3|Outcome|Unblinded Digital Activity Tracker / Smart Text Messaging|
691209|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
691210|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
691211|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
691212|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
691213|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
691214|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
691215|NCT01917812|O2|Outcome|Unblinded Digital Activity Tracker|
691216|NCT01917812|O1|Outcome|Blinded Digital Activity Tracker|
691217|NCT01917812|E3|Reported Event|Unblinded Digital Activity Tracker / Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Smart Text Messaging = Group receives personalized, health coaching via smart text messages.~Unblinded Digital Activity Tracker~Smart Text Messaging"
691218|NCT01917812|E2|Reported Event|Unblinded Digital Activity Tracker / No Smart Text Messaging|"Unblinded Digital Activity Tracker = Group unblinded to the numeric physical activity feedback information provided by the digital activity tracker.~Unblinded Digital Activity Tracker"
691219|NCT01917812|E1|Reported Event|Blinded Digital Activity Tracker|"Blinded Digital Activity Tracker = Group wears the tracker but is blinded to the numeric physical activity feedback information provided by the tracker.~Blinded Digital Activity Tracker"
691220|NCT01917773|B1|Baseline|Octreotide|"Fasting motility was recorded for at least 60 minutes.~Octreotide 1mcg/kg, maximum of 50mcg was administered subcutaneously (one hour after application of EMLA topical cream). Motility was then recorded for 45-60 minutes.~Patients were then offered a high-fat, high-energy meal as described elsewhere, and motility was recorded for 60 minutes.~Patients then received 1 to 2 doses of bisacodyl (0.2 mg/kg, maximum of 10 mg) through the motility catheter, and motility was recorded."
691301|NCT01916967|P2|Participant Flow|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691627|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691221|NCT01917773|P1|Participant Flow|Octreotide|This was a non-randomized, single center, open label, and prospective study. Thirteen patients were enrolled in the study. All patient received Octreotide as per study protocol.
691222|NCT01917773|O3|Outcome|45 Minutes|The MI for the 45 minutes before and after octreotide infusion was measured.
691223|NCT01917773|O2|Outcome|30 Minutes|The MI for the 30 minutes before and after octreotide infusion was measured.
691224|NCT01917773|O1|Outcome|15 Minutes|The MI for the 15 minutes before and after octreotide infusion was measured.
691225|NCT01917773|E1|Reported Event|All Patients|All 13 patient received octreotide injection. Motility Index (MI) (mm Hg) for the 15 minutes before and after octreotide infusion was measured.
691226|NCT01917656|B3|Baseline|Total|Total of all reporting groups
691227|NCT01917656|B2|Baseline|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691228|NCT01917656|B1|Baseline|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691229|NCT01917656|P2|Participant Flow|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691230|NCT01917656|P1|Participant Flow|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691231|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691232|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691233|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691234|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691235|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691236|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691237|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691238|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691239|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691240|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691241|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691242|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691243|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691244|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691245|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691246|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691247|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691248|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691249|NCT01917656|O2|Outcome|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691250|NCT01917656|O1|Outcome|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691251|NCT01917656|E2|Reported Event|Sulfonylurea and Metformin|Subjects continued on pre-trial sulfonylurea tablet treatment, in combination with pre-trial tablet metformin of unchanged dose.
691252|NCT01917656|E1|Reported Event|Liraglutide and Metformin|Liraglutide 1.8 mg administered once daily subcutaneously, in combination with pre-trial tablet metformin of unchanged dose.
691253|NCT01917526|B3|Baseline|Total|Total of all reporting groups
691254|NCT01917526|B2|Baseline|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
691255|NCT01917526|B1|Baseline|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
691256|NCT01917526|P2|Participant Flow|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
691257|NCT01917526|P1|Participant Flow|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
691258|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
700403|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
691259|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
691260|NCT01917526|O2|Outcome|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
691261|NCT01917526|O1|Outcome|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
691262|NCT01917526|E2|Reported Event|Oxygen Cannula|"Oxygen cannula with oxygen flow 4 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen cannula"
691263|NCT01917526|E1|Reported Event|Oxygen Mask|"Oxygen mask with oxygen flow 5 L/min will be given to allocated post general anesthesia patients. The incidence and causes of hypoxemia will be recorded.~oxygen mask"
691264|NCT01917344|B1|Baseline|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
691265|NCT01917344|P1|Participant Flow|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
691266|NCT01917344|O1|Outcome|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
691267|NCT01917344|E1|Reported Event|Adults With PKU|"MRI, EEG, neuropsychological testing, neurological examination, blood draw, diet diary, physical examination~MRI"
691268|NCT01917214|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691269|NCT01917214|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691270|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691271|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691272|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691273|NCT01917214|O1|Outcome|mRCC Cohort: Sutent Therapy and BSC|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691274|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691275|NCT01917214|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort: Sutent Therapy|Participants diagnosed with mRCC who received systemic therapy with Sutent (sunitinib malate) 25 mg, 37.5 mg or 50 mg as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691276|NCT01917214|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who received either systemic therapy (Sutent [sunitinib malate] 25 milligram [mg], 37.5 mg or 50 mg or other systemic drugs [like bevacizumab, everolimus, pazopanib, sorafenib, temsirolimus]) OR best supportive care (BSC) as first line of treatment between 1 January 2006 and 31 December 2011 were observed retrospectively.
691277|NCT01916980|B3|Baseline|Total|Total of all reporting groups
691278|NCT01916980|B2|Baseline|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691279|NCT01916980|B1|Baseline|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691280|NCT01916980|P2|Participant Flow|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691281|NCT01916980|P1|Participant Flow|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691302|NCT01916967|P1|Participant Flow|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691303|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
730094|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
691282|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691283|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691284|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691285|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691286|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691287|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691288|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691289|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691290|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691291|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691292|NCT01916980|O2|Outcome|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691293|NCT01916980|O1|Outcome|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691294|NCT01916980|E2|Reported Event|Desloratadine: Dermal Pruritus|Participants with dermal pruritus receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691295|NCT01916980|E1|Reported Event|Desloratadine: Eczema/Dermatitis|Participants with eczema/dermatitis receive desloratadine 5 mg, taken as one 5-mg tablet, orally once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine can be increased from 5 mg/day to 10 mg/day (two 5-mg tablets, orally once daily in the evening for up to 8 weeks), if criteria for dose up-titration are met, there is insufficient anti-pruritic efficacy and there is no safety concern.
691296|NCT01916967|B4|Baseline|Total|Total of all reporting groups
691297|NCT01916967|B3|Baseline|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691298|NCT01916967|B2|Baseline|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691299|NCT01916967|B1|Baseline|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691300|NCT01916967|P3|Participant Flow|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691624|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691304|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691305|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691306|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691307|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691308|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691309|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691310|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691311|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691312|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691313|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691314|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691315|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691316|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691317|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691318|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691319|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691320|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691321|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691322|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691323|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691324|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691325|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691326|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691327|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
691328|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691329|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691330|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691331|NCT01916967|O4|Outcome|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
691332|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691333|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691334|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691335|NCT01916967|O3|Outcome|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691336|NCT01916967|O2|Outcome|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691337|NCT01916967|O1|Outcome|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691338|NCT01916967|E4|Reported Event|Desloratadine 5 mg→Placebo|Participant received desloratadine 5 mg, as one 5-mg tabet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
691339|NCT01916967|E3|Reported Event|Placebo|Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks
691340|NCT01916967|E2|Reported Event|Desloratadine 10 mg|Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks
691341|NCT01916967|E1|Reported Event|Desloratadine 5 mg|Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
691342|NCT01916928|B1|Baseline|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
691343|NCT01916928|P1|Participant Flow|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
691344|NCT01916928|O1|Outcome|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
691345|NCT01916928|E1|Reported Event|Non-viable Pregnancy|Women presenting with stillbirth, defined as fetal death occurring after 20 weeks gestation or with miscarriage, defined as fetal death prior to 20 weeks gestation.
691346|NCT01916681|B5|Baseline|Total|Total of all reporting groups
691347|NCT01916681|B4|Baseline|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
691348|NCT01916681|B3|Baseline|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691349|NCT01916681|B2|Baseline|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691350|NCT01916681|B1|Baseline|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691351|NCT01916681|P4|Participant Flow|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691352|NCT01916681|P3|Participant Flow|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691353|NCT01916681|P2|Participant Flow|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691354|NCT01916681|P1|Participant Flow|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691355|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691356|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691357|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691358|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691359|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691360|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691361|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691362|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691363|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691364|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691365|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691366|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691367|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691368|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691369|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691370|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691371|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691372|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691373|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691374|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691375|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691376|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691377|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691378|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691379|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691380|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691381|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691382|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691383|NCT01916681|O4|Outcome|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Pitocin: A cervical foley combined with pitocin will be used to induce the patient"
691384|NCT01916681|O3|Outcome|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691385|NCT01916681|O2|Outcome|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691386|NCT01916681|O1|Outcome|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691387|NCT01916681|E4|Reported Event|Cervical Foley & Pitocin|"Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor.~Cervical Foley & Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient"
691388|NCT01916681|E3|Reported Event|Cervical Foley Alone|"Patients randomized to this arm will receive a cervical foley to induce their labor.~Cervical Foley Alone: A cervical foley alone will be used to induce the patient"
691389|NCT01916681|E2|Reported Event|Misoprostol Only|"Patients randomized to this arm will receive misoprostol to induce their labor.~Misoprostol Alone: Misoprostol will be used alone to induce the patient"
691390|NCT01916681|E1|Reported Event|Cervical Foley & Misoprostol|"Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor.~Cervical Foley & Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient."
691391|NCT01916629|B3|Baseline|Total|Total of all reporting groups
691392|NCT01916629|B2|Baseline|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
691393|NCT01916629|B1|Baseline|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
691394|NCT01916629|P2|Participant Flow|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
691395|NCT01916629|P1|Participant Flow|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
691396|NCT01916629|O2|Outcome|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
691397|NCT01916629|O1|Outcome|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
691398|NCT01916629|E2|Reported Event|Placebo - Sunscreen (SPF 2)|"Placebo - Sunscreen (SPF 2)~Placebo - Sunscreen (SPF 2): Placebo - Sunscreen (SPF 2)"
691399|NCT01916629|E1|Reported Event|Photocil for Psoriasis|"Active Drug - Photocil for Psoriasis~Photocil for Psoriasis: Photocil for Psoriasis"
691400|NCT01916590|B3|Baseline|Total|Total of all reporting groups
691401|NCT01916590|B2|Baseline|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
691402|NCT01916590|B1|Baseline|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
691403|NCT01916590|P2|Participant Flow|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
691404|NCT01916590|P1|Participant Flow|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
691625|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691405|NCT01916590|O2|Outcome|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
691406|NCT01916590|O1|Outcome|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
691407|NCT01916590|E2|Reported Event|Placebo|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine) through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with saline solution, and the infusion will be started at 6 ml/hr. gh the catheter.~placebo"
691408|NCT01916590|E1|Reported Event|Bupivacaine|"All patients who give consent will undergo ultrasound guided placement of a femoral catheter with injection of 30 cc of 0.5% bupivacaine (without epinephrine)through the catheter. After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.~Bupivicaine: After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter."
691409|NCT01916304|B1|Baseline|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691410|NCT01916304|P1|Participant Flow|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691411|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691412|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691413|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691414|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691415|NCT01916304|O1|Outcome|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691416|NCT01916304|E1|Reported Event|Levothyroxine Sodium New Formulation|Levothyroxine (25-225 μg), tablets, orally, once daily for up to 12 to 20 weeks. Dose administered depends on the thyroid stimulating hormone level.
691417|NCT01916226|B5|Baseline|Total|Total of all reporting groups
691418|NCT01916226|B4|Baseline|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691419|NCT01916226|B3|Baseline|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691420|NCT01916226|B2|Baseline|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691421|NCT01916226|B1|Baseline|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691422|NCT01916226|P4|Participant Flow|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691423|NCT01916226|P3|Participant Flow|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691424|NCT01916226|P2|Participant Flow|Cetirizine 10 mg|Participants self-administered a 10 milligram (mg) cetrizine capsule once daily in the AM for 2 weeks.
691425|NCT01916226|P1|Participant Flow|FPNS 200 μg|Participants self-administered fluticasone propionate nasal spray (FPNS) 200 micrograms (µg) per day as two sprays in each nostril (50 μg per spray) once daily in the morning (AM) for 2 weeks.
691426|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691427|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691428|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691429|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691430|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691431|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691432|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691433|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691434|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691626|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691435|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691436|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691437|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691438|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691439|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691440|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691441|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691442|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691443|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691444|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691445|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691446|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691447|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691448|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691449|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691450|NCT01916226|O4|Outcome|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691451|NCT01916226|O3|Outcome|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691452|NCT01916226|O2|Outcome|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691453|NCT01916226|O1|Outcome|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks
691454|NCT01916226|E4|Reported Event|Cetirizine Matching Placebo|Participants self-administered matching placebo to cetrizine capsule once daily in the AM for 2 weeks.
691455|NCT01916226|E3|Reported Event|FPNS Matching Placebo|Participants self-administered matching placebo to FPNS as two sprays in each nostril (50 µg per spray) once daily in the AM for 2 weeks.
691456|NCT01916226|E2|Reported Event|Cetirizine 10 mg|Participants self-administered a 10 mg cetrizine capsule once daily in the AM for 2 weeks.
691457|NCT01916226|E1|Reported Event|FPNS 200 μg|Participants self-administered FPNS 200 µg per day as two sprays in each nostril (50 μg per spray) once daily in the AM for 2 weeks.
691458|NCT01916109|B1|Baseline|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
691459|NCT01916109|P1|Participant Flow|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
691460|NCT01916109|O1|Outcome|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
691461|NCT01916109|E1|Reported Event|Gemcitabine, Carboplatin, and Panitumumab (GCaP)|Gemcitabine, Carboplatin, and Panitumumab (GCaP) as Neoadjuvant Chemotherapy in Patients with Muscle-Invasive Bladder Cancer
691462|NCT01915914|B1|Baseline|Overall|Participants who entered the Acute Phase received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to the affected sites and any newly occurring atopic dermatitis (AD) sites. The efficacy and safety in the Acute Phase assessed every 2 weeks up to 4 weeks or until treatment success. Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with physician static global assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, participants received emollient BID plus FP 0.05% cream OD twice a week, or emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691463|NCT01915914|P4|Participant Flow|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691464|NCT01915914|P3|Participant Flow|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
691465|NCT01915914|P2|Participant Flow|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
691466|NCT01915914|P1|Participant Flow|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
691467|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
691468|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691469|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
691470|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
691471|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691472|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
691473|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691474|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks to the affected and unaffected areas.
691475|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a weekup to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691476|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe).During the Maintenance Phase, the participants received emollient BID up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691477|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week, up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691478|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
691479|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
691480|NCT01915914|O1|Outcome|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety in the Acute Phase was assessed every 2 weeks up to 4 weeks or until treatment success.
691481|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691482|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691483|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks.
691484|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
691485|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID, up to 20 weeks. Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691486|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.Participants who completed the study treatment in the Maintenance Phase without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691487|NCT01915914|O2|Outcome|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
691488|NCT01915914|O1|Outcome|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) <=1; and the improvement >=2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
691489|NCT01915914|E4|Reported Event|Follow-up: Emollient|Participants who completed the study treatment in the Maintenance Phase in either treatment group without a relapse, were entered into the Follow-up Phase. Emollient was applied BID up to 12 weeks.
691490|NCT01915914|E3|Reported Event|Emollient|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as PSGA less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). The participants received emollient BID up to 20 weeks.
691491|NCT01915914|E2|Reported Event|Emollient Plus FP 0.05% Cream|Participants with treatment success during the Acute Phase were enrolled in the Maintenance Phase. Treatment success is defined as participants with Physician Static Global Assessment (PSGA) less than or equal to 1; and the improvement greater than or equal to 2 compared to Baseline (the six-point scale of PSGA score range from 0 to 5 where 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe, 5=very severe). During the Maintenance Phase, the participants received emollient BID plus FP 0.05% cream OD twice a week up to 20 weeks. FP 0.05% cream was applied to all healed sites and any newly occurring sites. Emollient was applied before the application of FP 0.05% cream to the affected and unaffected areas.
691492|NCT01915914|E1|Reported Event|FP 0.05% Cream|Participants who satisfied eligibility criteria received FP 0.05% cream BID up to 4 weeks. FP 0.05% cream was applied to affected sites and any newly occurring atopic dermatitis (AD) sites. Investigator assessed Eczema Area, AD Severity, Visual Skin Assessment, and conducted physical examination, vital sign measurement in the Acute Phase. The efficacy and safety of FP 0.05% cream was assessed every 2 weeks up to 4 weeks or until treatment success.
691493|NCT01915849|B5|Baseline|Total|Total of all reporting groups
691494|NCT01915849|B4|Baseline|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
691495|NCT01915849|B3|Baseline|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
691496|NCT01915849|B2|Baseline|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
691497|NCT01915849|B1|Baseline|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
691498|NCT01915849|P4|Participant Flow|Sequence 4: Placebo/LIK066 150 mg/LIK066 15 mg/LIK066 50 mg|Period 1- Placebo treatment once daily (q.d.) for 4 days. Period 2- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 50 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
691499|NCT01915849|P3|Participant Flow|Sequence 3: LIK066 150 mg/LIK066 50 mg/Placebo/LIK066 15 mg|Period 1- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 3- Placebo treatment once daily for 4 days. Period 4- LIK066 15 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
691500|NCT01915849|P2|Participant Flow|Sequence 2: LIK066 50 mg/LIK066 15 mg/LIK066 150 mg/Placebo|Period 1- LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 2- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 3- LIK066 150 mg treatment once daily (q.d.) for 4 days. Period 4- Placebo treatment once daily for 4 days. 14 days washout periods between treatment periods.
691501|NCT01915849|P1|Participant Flow|Sequence 1: LIK066 15 mg/Placebo/LIK066 50 mg/LIK066 150 mg|Period 1- LIK066 15 mg treatment once daily (q.d.) for 4 days. Period 2- Placebo treatment once daily for 4 days. Period 3 - LIK066 50 mg treatment once daily (q.d.) for 4 days. Period 4- LIK066 150 mg treatment once daily (q.d.) for 4 days. 14 days washout periods between treatment periods.
691502|NCT01915849|O4|Outcome|Placebo|All patients who have received placebo once daily for 4 days.
691503|NCT01915849|O3|Outcome|LIK066 150 mg|All patients who have received LIK066 150 mg once daily for 4 days.
691504|NCT01915849|O2|Outcome|LIK066 50 mg|All patients who have received LIK066 50 mg once daily for 4 days.
691505|NCT01915849|O1|Outcome|LIK066 15 mg|All patients who have received LIK066 15 mg once daily for 4 days.
691506|NCT01915849|E4|Reported Event|LIK066 150 mg|LIK066 150 mg
691507|NCT01915849|E3|Reported Event|LIK066 50 mg|LIK066 50 mg
691508|NCT01915849|E2|Reported Event|LIK066 15 mg|LIK066 15 mg
691509|NCT01915849|E1|Reported Event|Placebo|Placebo
691510|NCT01915823|B3|Baseline|Total|Total of all reporting groups
691511|NCT01915823|B2|Baseline|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
691512|NCT01915823|B1|Baseline|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
691513|NCT01915823|P2|Participant Flow|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
691514|NCT01915823|P1|Participant Flow|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
691515|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
691546|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
730095|NCT01694108|O2|Outcome|Control Children|No intervention
691516|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
691517|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
691518|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
691519|NCT01915823|O2|Outcome|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
691520|NCT01915823|O1|Outcome|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
691521|NCT01915823|E2|Reported Event|Dymista Vehicle|"Dose: vehicle only Regimen: 1 spray per nostril twice daily~Dymista vehicle"
691522|NCT01915823|E1|Reported Event|Dymista|"(azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137mcg/50mcg: Mode of Administration: Topical/intranasal spray~Dose: 548 mcg azelastine hydrochloride / 200 mcg fluticasone propionate, total daily dose Regimen: 1 spray per nostril twice daily~azelastine hydrochloride and fluticasone propionate"
691523|NCT01915732|B3|Baseline|Total|Total of all reporting groups
691524|NCT01915732|B2|Baseline|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691525|NCT01915732|B1|Baseline|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691526|NCT01915732|P2|Participant Flow|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691527|NCT01915732|P1|Participant Flow|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691528|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691529|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691530|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691531|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691532|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691533|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691534|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691535|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691536|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691537|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691538|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691539|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691540|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691541|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691542|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691543|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691544|NCT01915732|O2|Outcome|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691545|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691619|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691547|NCT01915732|O1|Outcome|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691548|NCT01915732|E2|Reported Event|Dalin Gel|Participants topically applied Dalin Gel (clindamycin phosphate [equivalent to 1% clindamycin]) twice daily (once in the morning and once in the evening) to facial acne for 12 weeks.
691549|NCT01915732|E1|Reported Event|Duac Once Daily Gel|Participants (Par.) topically applied Duac Once Daily Gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) in the evening to facial acne for 12 weeks.
691550|NCT01915173|B5|Baseline|Total|Total of all reporting groups
691551|NCT01915173|B4|Baseline|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
691552|NCT01915173|B3|Baseline|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
691553|NCT01915173|B2|Baseline|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
691554|NCT01915173|B1|Baseline|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
691555|NCT01915173|P4|Participant Flow|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
691556|NCT01915173|P3|Participant Flow|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
691557|NCT01915173|P2|Participant Flow|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
691558|NCT01915173|P1|Participant Flow|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
691559|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
691560|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
691561|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
691562|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
691563|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
691564|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
691565|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
691566|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
691567|NCT01915173|O4|Outcome|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
691568|NCT01915173|O3|Outcome|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
691569|NCT01915173|O2|Outcome|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
691570|NCT01915173|O1|Outcome|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
691571|NCT01915173|E4|Reported Event|Supplement + Expanded Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Expanded Interview"
691572|NCT01915173|E3|Reported Event|Placebo + Expanded Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Expanded Interview"
691573|NCT01915173|E2|Reported Event|Supplement + Standard Interview|"Supplement, 2 tablets sublingually 3 times a day for 2 weeks.~Supplement = Acidil: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C~Standard Interview"
691574|NCT01915173|E1|Reported Event|Placebo + Standard Interview|"Placebo, 2 tablets sublingually 3 times a day for 2 weeks.~Placebo: Lactose tablets~Standard Interview"
691575|NCT01915108|B5|Baseline|Total|Total of all reporting groups
691576|NCT01915108|B4|Baseline|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691577|NCT01915108|B3|Baseline|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691578|NCT01915108|B2|Baseline|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691579|NCT01915108|B1|Baseline|Group R0|remifentanil Ce of 0 ng/ml
691620|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691621|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691580|NCT01915108|P4|Participant Flow|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691581|NCT01915108|P3|Participant Flow|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691582|NCT01915108|P2|Participant Flow|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691583|NCT01915108|P1|Participant Flow|Group R0|remifentanil Ce of 0 ng/ml
691584|NCT01915108|O4|Outcome|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691585|NCT01915108|O3|Outcome|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691586|NCT01915108|O2|Outcome|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691587|NCT01915108|O1|Outcome|Group R0|remifentanil Ce of 0 ng/ml
691588|NCT01915108|E4|Reported Event|Group R1.0|"remifentanil Ce of 1.0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691589|NCT01915108|E3|Reported Event|Group R0.5|"remifentanil Ce of 0.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691590|NCT01915108|E2|Reported Event|Group R1.5|"remifentanil Ce of 1.5 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691591|NCT01915108|E1|Reported Event|Group R0|"remifentanil Ce of 0 ng/ml~Remifentanil: All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml)."
691592|NCT01914926|B3|Baseline|Total|Total of all reporting groups
691593|NCT01914926|B2|Baseline|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
691594|NCT01914926|B1|Baseline|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
691595|NCT01914926|P2|Participant Flow|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
691596|NCT01914926|P1|Participant Flow|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
691597|NCT01914926|O2|Outcome|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
691598|NCT01914926|O1|Outcome|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
691599|NCT01914926|E2|Reported Event|Diltiazem Study Group|Patients receiving diltiazem administered parenterally at a dose of 0.25 mg/kg (to a maximum dose of 30 mg)
691600|NCT01914926|E1|Reported Event|Metoprolol Study Group|Patients Receiving metoprolol administered at a dose of 0.15 mg/kg (to a maximum dose of 10 mg)
691601|NCT01914757|B4|Baseline|Total|Total of all reporting groups
691602|NCT01914757|B3|Baseline|Placebo|Placebo administered subcutaneously
691603|NCT01914757|B2|Baseline|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691604|NCT01914757|B1|Baseline|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691605|NCT01914757|P3|Participant Flow|Placebo|Placebo administered subcutaneously
691606|NCT01914757|P2|Participant Flow|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691607|NCT01914757|P1|Participant Flow|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691608|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691609|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691610|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691611|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691612|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691613|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691614|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691615|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691616|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691617|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691618|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
730096|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
691628|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691629|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691630|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691631|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691632|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691633|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691634|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691635|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691636|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691637|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691638|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691639|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691640|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691641|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691642|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691643|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691644|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691645|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691646|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691647|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691648|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691649|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691650|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691651|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691652|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691653|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691654|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691655|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691656|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691657|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691658|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691659|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691660|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691661|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691662|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691663|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691664|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691665|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691666|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691667|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691668|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691669|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691670|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691671|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691672|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691673|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691674|NCT01914757|O3|Outcome|Placebo|Placebo administered subcutaneously
691675|NCT01914757|O2|Outcome|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691676|NCT01914757|O1|Outcome|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691677|NCT01914757|E3|Reported Event|Placebo|Placebo administered subcutaneously
691678|NCT01914757|E2|Reported Event|Benralizumab 30 mg q.8 Weeks|Benralizumab administered subcutaneously every 8 weeks
691679|NCT01914757|E1|Reported Event|Benralizumab 30 mg q.4 Weeks|Benralizumab administered subcutaneously every 4 weeks
691680|NCT01914679|B1|Baseline|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
691681|NCT01914679|P1|Participant Flow|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments), and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
691682|NCT01914679|O1|Outcome|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
691711|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691750|NCT01913795|E2|Reported Event|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
691683|NCT01914679|E1|Reported Event|Sham and RINCE Treatment|"4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments).~RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal."
691684|NCT01914666|B4|Baseline|Total|Total of all reporting groups
691685|NCT01914666|B3|Baseline|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691686|NCT01914666|B2|Baseline|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691687|NCT01914666|B1|Baseline|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691688|NCT01914666|P3|Participant Flow|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691689|NCT01914666|P2|Participant Flow|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY [NCT#01855919]) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691690|NCT01914666|P1|Participant Flow|Naïve|New participants (Pts) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691691|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691692|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691693|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691694|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691695|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691696|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691697|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691698|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691699|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691700|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691701|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691702|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691703|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691704|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691705|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691706|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691707|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691708|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691709|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691710|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691712|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691713|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691714|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691715|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691716|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691717|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691718|NCT01914666|O3|Outcome|Rollover (Pre-Duloxetine 60 mg)|Consecutive participants (randomized to duloxetine in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691719|NCT01914666|O2|Outcome|Rollover (Pre-Placebo)|Consecutive participants (randomized to placebo in study F1J-JE-HMGY) administered duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691720|NCT01914666|O1|Outcome|Naïve|New participants administered duloxetine 20 milligrams (mg) during Week 1, 40 mg during Week 2, and 60 mg for Weeks 3-50. Tapering doses of 40 mg for Week 51 and 20 mg for Week 52.
691721|NCT01914666|E1|Reported Event|Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg)|All participants from Naïve, Rollover (Pre-Placebo), Rollover (Pre-Duloxetine 60 mg) groups combined.
691722|NCT01914003|B3|Baseline|Total|Total of all reporting groups
691723|NCT01914003|B2|Baseline|Control|Individual does not have any known CSID mutations.
691724|NCT01914003|B1|Baseline|CSID Mutations|Individual has one or more known CSID mutations.
691725|NCT01914003|P2|Participant Flow|Control|Individual does not have any known CSID mutations.
691726|NCT01914003|P1|Participant Flow|CSID Mutations|Individual has one or more known CSID mutations.
691727|NCT01914003|O2|Outcome|Control|Individual does not have any known CSID mutations.
691728|NCT01914003|O1|Outcome|CSID Mutations|Individual has one or more known CSID mutations.
691729|NCT01914003|E2|Reported Event|Control|Individual does not have any known CSID mutations.
691730|NCT01914003|E1|Reported Event|CSID Mutations|Individual has one or more known CSID mutations.
691731|NCT01913795|B5|Baseline|Total|Total of all reporting groups
691732|NCT01913795|B4|Baseline|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
691733|NCT01913795|B3|Baseline|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
691734|NCT01913795|B2|Baseline|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
691735|NCT01913795|B1|Baseline|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
691736|NCT01913795|P4|Participant Flow|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
691737|NCT01913795|P3|Participant Flow|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
691738|NCT01913795|P2|Participant Flow|Sham and no IPM|sham air purifiers and no school integrated pest management environmental intervention
691739|NCT01913795|P1|Participant Flow|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
691740|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
691741|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
691742|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
691743|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
691744|NCT01913795|O4|Outcome|Sham and IPM|"5 subjects~classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
691745|NCT01913795|O3|Outcome|Air Purifier and no IPM|"9 subjects~air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
691746|NCT01913795|O2|Outcome|Sham and no IPM|"7 subjects~sham air purifiers and no school integrated pest management environmental intervention"
691747|NCT01913795|O1|Outcome|Air Purifier + IPM|"4 subjects~classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
691748|NCT01913795|E4|Reported Event|Sham and IPM|"classroom sham air purifiers and school integrated pest management~integrated pest management: integrated pest management and environmental strategy"
691749|NCT01913795|E3|Reported Event|Air Purifier and no IPM|"air purifiers and no school integrated pest management environmental intervention~air purifier: air purifiers"
730097|NCT01694108|O2|Outcome|Control Children|No intervention
691751|NCT01913795|E1|Reported Event|Air Purifier + IPM|"classroom air purifiers and school integrated pest management environmental intervention~integrated pest management: integrated pest management and environmental strategy~air purifier: air purifiers"
691752|NCT01913483|B3|Baseline|Total|Total of all reporting groups
691753|NCT01913483|B2|Baseline|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
691754|NCT01913483|B1|Baseline|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
691755|NCT01913483|P2|Participant Flow|Unfractionated Heparin|Unfractionated heparin (UFH) was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
691756|NCT01913483|P1|Participant Flow|Bivalirudin|Bivalirudin was administered as an intravenous (IV) bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 milligrams (mg)/kilogram [kg]) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/hour (h) (or 1 mg/kg/h for participants with an estimated glomerular filtration rate [eGFR] <30 milliliters per minute [mL/min]).
691757|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
691758|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
691759|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
691760|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
691761|NCT01913483|O2|Outcome|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 U/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
691762|NCT01913483|O1|Outcome|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
691763|NCT01913483|E2|Reported Event|Unfractionated Heparin|UFH was administered as an IV bolus for the duration of the procedure (mean duration of 48.6 minutes). UFH was administered via weight-based IV bolus at a dose of 50 units (U)/kg to 70 U/kg. Additional bolus doses were administered per standard-of-care use.
691764|NCT01913483|E1|Reported Event|Bivalirudin|Bivalirudin was administered as an IV bolus and infusion for the duration of the procedure (mean duration of 48.6 minutes). The bolus (0.75 mg/kg) was administered via systemic IV administration. Immediately after the bolus, an IV infusion of bivalirudin was initiated at a dose of 1.75 mg/kg/h (or 1 mg/kg/h for participants with an eGFR <30 mL/min).
691765|NCT01913470|B3|Baseline|Total|Total of all reporting groups
691766|NCT01913470|B2|Baseline|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
691767|NCT01913470|B1|Baseline|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo.
691768|NCT01913470|P2|Participant Flow|Placebo Followed by Losartan|Recipients of treatment with a placebo for 8 weeks followed by 8 weeks of treatment with losartan.
691769|NCT01913470|P1|Participant Flow|Losartan Followed by Placebo|Recipients of treatment with losartan for 8 weeks followed by 8 weeks of treatment with a placebo
691770|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
691771|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
691772|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
691773|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
691774|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
691775|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
691776|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
691777|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
691778|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
691779|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
691780|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks
691781|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
691782|NCT01913470|O2|Outcome|Placebo|Recipients of treatment with a placebo for 8 weeks.
691783|NCT01913470|O1|Outcome|Losartan|Recipients of treatment with losartan for 8 weeks.
691784|NCT01913470|E2|Reported Event|Placebo|Recipients of treatment with a placebo for 8 weeks.
691785|NCT01913470|E1|Reported Event|Losartan|Recipients of treatment with losartan for 8 weeks.
691828|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691786|NCT01913041|B1|Baseline|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
691787|NCT01913041|P1|Participant Flow|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
691788|NCT01913041|O1|Outcome|Investigation Group|This is an epidemiology study in which all the data from the subjects enrolled will be collected and analysis to investigate the current patient warming condition and actual perioperative hyperthermia rate in the elective operation with general anesthesia. During the whole procedure none intervention is administered
691789|NCT01913041|E1|Reported Event|Observation Group|There is only one group, The main purpose of this investigation is to observe the hypothermia rate in elective operations under general anaesthesia in Peking in China.
691790|NCT01912781|B3|Baseline|Total|Total of all reporting groups
691791|NCT01912781|B2|Baseline|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691792|NCT01912781|B1|Baseline|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691793|NCT01912781|P2|Participant Flow|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691794|NCT01912781|P1|Participant Flow|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691795|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691796|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691797|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691798|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691799|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691800|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691801|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691802|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691803|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691804|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691805|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691806|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691807|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691808|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691809|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691810|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691811|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691812|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691813|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691814|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691815|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691816|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691817|NCT01912781|O2|Outcome|Boston Simplus|Multi-action solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691818|NCT01912781|O1|Outcome|FID 120974A|Contact lens disinfecting solution used with gas permeable contact lenses (study lenses) on a daily basis for 90 days
691819|NCT01912781|E3|Reported Event|Boston Simplus|All subjects who were exposed to Boston Simplus
691820|NCT01912781|E2|Reported Event|FID 120974A|All subjects who were exposed to FID 120947A
691821|NCT01912781|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
691822|NCT01912768|B3|Baseline|Total|Total of all reporting groups
691823|NCT01912768|B2|Baseline|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691824|NCT01912768|B1|Baseline|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691825|NCT01912768|P2|Participant Flow|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691826|NCT01912768|P1|Participant Flow|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691827|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691829|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691830|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691831|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691832|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691833|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691834|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691835|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691836|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691837|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691838|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691839|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691840|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691841|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691842|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691843|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691844|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691845|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691846|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691847|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691848|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691849|NCT01912768|O2|Outcome|Renu Fresh|Multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691850|NCT01912768|O1|Outcome|FID 120947A|Contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
691851|NCT01912768|E3|Reported Event|Renu Fresh|All subjects who were exposed to renu fresh
691852|NCT01912768|E2|Reported Event|FID 120947A|All subjects who were exposed to FID 120947A
691853|NCT01912768|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
691854|NCT01912599|B3|Baseline|Total|Total of all reporting groups
691855|NCT01912599|B2|Baseline|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691856|NCT01912599|B1|Baseline|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691857|NCT01912599|P2|Participant Flow|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691885|NCT01912404|O2|Outcome|Placebo|Matching Placebo capsules twice daily for 28 days
691886|NCT01912404|O1|Outcome|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
691887|NCT01912404|E2|Reported Event|Placebo|Matching Placebo capsules twice daily for 28 days
691888|NCT01912404|E1|Reported Event|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
691987|NCT01911689|O2|Outcome|Control Group|T2* value of control group is mean T2* values of the head, body and tail of pancreas respectively.The control group:without pancreatic disorders
691858|NCT01912599|P1|Participant Flow|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691859|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691860|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691861|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691862|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691863|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691864|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691889|NCT01912352|B1|Baseline|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
691890|NCT01912352|P1|Participant Flow|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
691891|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
730098|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
691865|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691866|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691867|NCT01912599|O2|Outcome|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691868|NCT01912599|O1|Outcome|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691869|NCT01912599|E2|Reported Event|Glaucoma|"Patients that are currently being treated for moderate to severe normal-tension glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691870|NCT01912599|E1|Reported Event|Non-Glaucomatous|"Patients with no history of glaucoma. Subjects will be fitted with Sensimed Triggerfish for 24 observation of IOP and with a blood pressure monitor for 24 hour observation of blood pressure trends.~Sensimed Triggerfish: IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period."
691871|NCT01912495|B1|Baseline|Boceprevir/Peginterferon/Ribavirin|Boceprevir with Peginterferon and Ribavirin
691872|NCT01912495|P1|Participant Flow|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
691873|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
691874|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|Boceprevir peginterferon and ribavirin
691875|NCT01912495|O1|Outcome|Boceprevir Peginterferon Ribavirin|12 week Boceprevir peginterferon and ribavirin
691876|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
691877|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week boceprevir, peginterferon and ribavirin in intention to treat group
691878|NCT01912495|O1|Outcome|Boceprevir, Peginterferon and Ribavirin|12 week Boceprevir, Peginterferon and Ribavirin
691879|NCT01912495|E1|Reported Event|Boceprevir|12 week Boceprevir, Peginterferon and Ribavirin in RVR4 group
691880|NCT01912404|B3|Baseline|Total|Total of all reporting groups
691881|NCT01912404|B2|Baseline|Placebo|Matching Placebo capsules twice daily for 28 days
691882|NCT01912404|B1|Baseline|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
691883|NCT01912404|P2|Participant Flow|Placebo|Matching Placebo capsules twice daily for 28 days
691884|NCT01912404|P1|Participant Flow|IDN-6556|IDN-6556 capsules, 25 mg twice daily for 28 days
691892|NCT01912352|O1|Outcome|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
691893|NCT01912352|E1|Reported Event|Methylphenidate|Participants were treated with methylphenidate (raning from 10mg to 63mg) for 8 weeks. Doses of MPH were titrated depending on symptoms and adverse eff ects at the 2nd and 4 th weeks of treatment.
691894|NCT01912339|B3|Baseline|Total|Total of all reporting groups
691895|NCT01912339|B2|Baseline|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691896|NCT01912339|B1|Baseline|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691897|NCT01912339|P3|Participant Flow|Crossover of Control Subjects|Subjects randomized to the control group will be offered the option to receive the Rezum treatment after the 3 month follow-up visit evaluations are completed. Subjects must decide to cross over by the end of the 6 month follow-up visit.
691898|NCT01912339|P2|Participant Flow|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691899|NCT01912339|P1|Participant Flow|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691900|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691901|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691902|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691903|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691904|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691905|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691906|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691907|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691908|NCT01912339|O2|Outcome|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691931|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
692031|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
691909|NCT01912339|O1|Outcome|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691910|NCT01912339|E2|Reported Event|Control|"Control: Rigid Cystoscopy~Rigid Cystoscopy: Endoscopy of the urinary bladder via the urethra."
691911|NCT01912339|E1|Reported Event|Treatment|"Rezum is a transurethral needle ablation procedure to treat BPH that can be performed in a clinic or out-patient setting. Rezum uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, your body will absorb the treated tissue through its natural healing response."
691912|NCT01912222|B4|Baseline|Total|Total of all reporting groups
691913|NCT01912222|B3|Baseline|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691914|NCT01912222|B2|Baseline|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691915|NCT01912222|B1|Baseline|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
691916|NCT01912222|P3|Participant Flow|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691917|NCT01912222|P2|Participant Flow|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691918|NCT01912222|P1|Participant Flow|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
691919|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691920|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691921|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
691922|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691923|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691924|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
691925|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691926|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691927|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
691928|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691929|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691930|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
691982|NCT01911689|O3|Outcome|Severe AP|Severe AP was defined as 7-10 points according to MRSI.
691983|NCT01911689|O2|Outcome|Moderate AP|Moderate AP was defined as 4-6 points according to MRSI.
691932|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691933|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function.
691934|NCT01912222|O3|Outcome|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691935|NCT01912222|O2|Outcome|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691936|NCT01912222|O1|Outcome|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
691937|NCT01912222|E3|Reported Event|Severe Hepatic Impairment (Ixazomib 1.5 mg)|Ixazomib 1.5 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with severe hepatic impairment.
691938|NCT01912222|E2|Reported Event|Moderate Hepatic Impairment (Ixazomib 2.3 mg)|Ixazomib 2.3 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with moderate hepatic impairment.
691939|NCT01912222|E1|Reported Event|Normal Hepatic Function (Ixazomib 4 mg)|Ixazomib 4 mg, capsule, orally, on Day 1 in the pharmacokinetic part (Part A, 15-day cycle) and once on Days 1, 8 and 15 in the 28 day treatment cycle part (Part B) in participants with normal hepatic function..
691940|NCT01911845|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
691941|NCT01911845|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
691942|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
691943|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
691944|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
691945|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
691946|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
691947|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
691948|NCT01911845|O2|Outcome|Methadone|Participants were on a stable opioid replacement therapy of methadone during the Treatment Period, and for at least six months prior to screening.
691949|NCT01911845|O1|Outcome|Buprenorphine ± Naloxone|Participants were on a stable opioid replacement therapy of buprenorphine ± naloxone during the Treatment Period, and for at least six months prior to screening.
691950|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
691951|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
691952|NCT01911845|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
691953|NCT01911845|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
691954|NCT01911780|B3|Baseline|Total|Total of all reporting groups
691955|NCT01911780|B2|Baseline|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691956|NCT01911780|B1|Baseline|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691957|NCT01911780|P2|Participant Flow|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691958|NCT01911780|P1|Participant Flow|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
730099|NCT01694108|O2|Outcome|Control Children|No intervention
691959|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691960|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691961|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo + Ext|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691962|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine + Ext|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691963|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691964|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691965|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691966|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691967|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691968|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691969|NCT01911780|O2|Outcome|Telmisartan + HCTZ + Placebo|telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691970|NCT01911780|O1|Outcome|Telmisartan + HCTZ + Amlodipine|telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily (after the 8-week double-blind period, patients will continue the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet)
691971|NCT01911780|E4|Reported Event|Telmisartan + HCTZ + Placebo - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks in the double-blind period. Adverse events which occurred in extension period were collected.
691972|NCT01911780|E3|Reported Event|Telmisartan + HCTZ + Amlodipine - Extension Period|Patients in the 52-week open label extension period taking 1 telmisartan 80 mg and hydrochlorothiazide 12.5 FDC tablet and 1 amlodipine 5 mg tablet who previously received telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks in the double blind period. Adverse events which occurred in extension period were collected.
691973|NCT01911780|E2|Reported Event|Telmisartan + HCTZ + Placebo - Double Blind Period|Telmisartan 80 mg + HCTZ FDC tablet and placebo matching amlodipine 5 mg capsule orally, once daily for 8 weeks (double-blind period)
691974|NCT01911780|E1|Reported Event|Telmisartan + HCTZ + Amlodipine - Double Blind Period|Telmisartan 80 mg + hydrochlorothiazide (HCTZ) 12.5 mg fixed dose combination (FDC) and amlodipine 5 mg capsule orally, once daily for 8 weeks (double blind period)
691975|NCT01911689|B3|Baseline|Total|Total of all reporting groups
691976|NCT01911689|B2|Baseline|Controlgroup|All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
691977|NCT01911689|B1|Baseline|Acute Pancreatitis|All AP patients underwent the MRI scan within three days after admission. All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.
691978|NCT01911689|P2|Participant Flow|Controlgroup|normal control group：without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases).
691979|NCT01911689|P1|Participant Flow|Acute Pancreatitis|acute pancreatitis group：(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination.
691980|NCT01911689|O2|Outcome|Severe AP|Severe AP was graded as the Apache II score ≥8 points.
691981|NCT01911689|O1|Outcome|Mild AP|Mild AP was graded as the Apache II score ＜ 7 points.
691988|NCT01911689|O1|Outcome|Acute Pancreatitis|T2* value of AP group is mean T2* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination
691989|NCT01911689|E2|Reported Event|Controlgroup|Not Including Serious
691990|NCT01911689|E1|Reported Event|Acute Pancreatitis|Not Including Serious
691991|NCT01911442|B4|Baseline|Total|Total of all reporting groups
691992|NCT01911442|B3|Baseline|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
691993|NCT01911442|B2|Baseline|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
691994|NCT01911442|B1|Baseline|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
691995|NCT01911442|P3|Participant Flow|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
691996|NCT01911442|P2|Participant Flow|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
691997|NCT01911442|P1|Participant Flow|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
691998|NCT01911442|O3|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
691999|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily~Lurasidone: Lurasidone 60 mg once daily"
692000|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
692001|NCT01911442|O3|Outcome|Placebo|"Placebo once daily~Placebo: Placebo"
692002|NCT01911442|O2|Outcome|Lurasidone 60 mg|"Lurasidone 60 mg once daily~Lurasidone: Lurasidone 60 mg once daily"
692003|NCT01911442|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone 20 mg daily: Lurasidone 20 mg once daily"
692004|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
692005|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
692006|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
692007|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
692008|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
692009|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
692010|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
692011|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
692012|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
692013|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
692014|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
692015|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
692016|NCT01911442|O3|Outcome|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
692017|NCT01911442|O2|Outcome|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
692018|NCT01911442|O1|Outcome|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
692019|NCT01911442|E3|Reported Event|Placebo|Subject received placebo to match lurasidone from Day 1 to Week 6 Visit
692020|NCT01911442|E2|Reported Event|Lurasidone 60 mg Once Daily|Subjects received lurasidone 20 mg/day from Days 1-3, 40 mg/day from Days 4-6 and 60 mg/day from Day 7 to Week 6 Visit. One-time dose reduction to Lurasidone 40 mg/day may occur in Weeks 2, 3 or 4 (ie, between Day 8 to Day 29, inclusive).
692021|NCT01911442|E1|Reported Event|Lurasidone 20 mg Once Daily|Subjects received 20 mg/day from Day 1 to Week 6 Visit
692022|NCT01911429|B4|Baseline|Total|Total of all reporting groups
692023|NCT01911429|B3|Baseline|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692024|NCT01911429|B2|Baseline|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692025|NCT01911429|B1|Baseline|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692026|NCT01911429|P3|Participant Flow|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692027|NCT01911429|P2|Participant Flow|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily Subjects received lurasidone 40/mg day from Days 1-3, and 80mg/day from days 4 to Week 6 visit"
692028|NCT01911429|P1|Participant Flow|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692029|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692030|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692032|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692033|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692034|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692035|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692036|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692037|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692038|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692039|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692040|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692041|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692042|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692043|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692044|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692045|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692046|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692047|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692048|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692049|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692050|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692051|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692052|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692053|NCT01911429|O3|Outcome|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692054|NCT01911429|O2|Outcome|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692055|NCT01911429|O1|Outcome|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692056|NCT01911429|E3|Reported Event|Placebo|"Placebo 40 or 80 mg once daily~Placebo 40 or 80 mg: Placebo 40 or 80 mg once daily"
692057|NCT01911429|E2|Reported Event|Lurasidone 80 mg|"Lurasidone 80 mg once daily~Lurasidone 80 mg: Lurasidone 80 mg once daily"
692058|NCT01911429|E1|Reported Event|Lurasidone 40 mg|"Lurasidone 40 mg once daily~Lurasidone 40 mg: Lurasidone 40 mg once daily"
692059|NCT01911403|B3|Baseline|Total|Total of all reporting groups
692060|NCT01911403|B2|Baseline|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692061|NCT01911403|B1|Baseline|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692062|NCT01911403|P2|Participant Flow|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692063|NCT01911403|P1|Participant Flow|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692064|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692065|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692066|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692067|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692068|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692069|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692070|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692071|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692072|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692073|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692074|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692075|NCT01911403|O2|Outcome|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692076|NCT01911403|O1|Outcome|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692077|NCT01911403|E2|Reported Event|Manual Compression|"Closure procedure by manual compression~Manual compression: Closure procedure by Manual compression"
692078|NCT01911403|E1|Reported Event|Angio-Seal|"Closure procedure by Angio-Seal~Angio-Seal: Closure procedure by angio-Seal"
692079|NCT01911390|B5|Baseline|Total|Total of all reporting groups
692080|NCT01911390|B4|Baseline|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692081|NCT01911390|B3|Baseline|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692147|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692434|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692082|NCT01911390|B2|Baseline|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
692083|NCT01911390|B1|Baseline|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
692084|NCT01911390|P4|Participant Flow|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692085|NCT01911390|P3|Participant Flow|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692086|NCT01911390|P2|Participant Flow|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
692087|NCT01911390|P1|Participant Flow|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
692088|NCT01911390|O4|Outcome|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692089|NCT01911390|O3|Outcome|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692090|NCT01911390|O2|Outcome|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
692091|NCT01911390|O1|Outcome|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
692092|NCT01911390|O4|Outcome|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692093|NCT01911390|O3|Outcome|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692094|NCT01911390|O2|Outcome|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
692095|NCT01911390|O1|Outcome|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
692096|NCT01911390|E4|Reported Event|Bean Powder and Rice Bran|"9 grams bean powder/day and 8 grams rice bran /day in smoothie or muffin.~Bean powder and rice bran: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692097|NCT01911390|E3|Reported Event|Rice Bran|"15 grams rice bran/day in smoothie or muffin.~Rice bran: USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties."
692098|NCT01911390|E2|Reported Event|Bean Powder|"1/4 cup beans (17.5 grams powder)/day in smoothie or muffin.~Bean powder: Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders."
692099|NCT01911390|E1|Reported Event|Control Arm|"No bean or rice bran additive in smoothie or muffin.~Control arm: No bean or rice bran additive in smoothie or muffin."
692100|NCT01911351|B3|Baseline|Total|Total of all reporting groups
692101|NCT01911351|B2|Baseline|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692102|NCT01911351|B1|Baseline|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692103|NCT01911351|P2|Participant Flow|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692104|NCT01911351|P1|Participant Flow|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692105|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692106|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692107|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692108|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692109|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692110|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692111|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692112|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692431|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692113|NCT01911351|O2|Outcome|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692114|NCT01911351|O1|Outcome|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692115|NCT01911351|E2|Reported Event|Nitrous Oxide|"Patients randomized to this arm will receive nitrous oxide plus standard management for their minor procedure.~Nitrous Oxide: Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure."
692116|NCT01911351|E1|Reported Event|Standard Management|Patients randomized to this arm will receive standard management alone for their minor procedure.
692117|NCT01911273|B3|Baseline|Total|Total of all reporting groups
692118|NCT01911273|B2|Baseline|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692119|NCT01911273|B1|Baseline|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692120|NCT01911273|P2|Participant Flow|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692121|NCT01911273|P1|Participant Flow|PF-03446962 Plus BSC|PF-03446962 7 milligram per kilogram (mg/kg) was administered intravenously (IV) as 1-hour infusion every two weeks (q2w) plus BSC
692122|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692123|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692124|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692125|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692126|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692127|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692128|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692129|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692130|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692131|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692132|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692133|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692134|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692135|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692136|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692137|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692138|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692139|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692140|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692141|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692142|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692143|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692144|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692145|NCT01911273|O1|Outcome|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692146|NCT01911273|O2|Outcome|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692148|NCT01911273|E2|Reported Event|BSC Alone|BSC might vary depending on the participant's signs and symptoms, site current practice, and country practice and might include medications and supportive measures deemed necessary to palliate disease-related symptoms and improve quality of life.
692149|NCT01911273|E1|Reported Event|PF-03446962 Plus BSC|PF-03446962 7 mg/kg was administered IV as 1-hour infusion q2w plus BSC
692150|NCT01911260|B5|Baseline|Total|Total of all reporting groups
692151|NCT01911260|B4|Baseline|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692152|NCT01911260|B3|Baseline|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692153|NCT01911260|B2|Baseline|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692154|NCT01911260|B1|Baseline|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692155|NCT01911260|P4|Participant Flow|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692156|NCT01911260|P3|Participant Flow|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692157|NCT01911260|P2|Participant Flow|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692158|NCT01911260|P1|Participant Flow|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692159|NCT01911260|O4|Outcome|Normal Height + Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692160|NCT01911260|O3|Outcome|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692432|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692161|NCT01911260|O2|Outcome|Growth Deficit + Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692162|NCT01911260|O1|Outcome|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692163|NCT01911260|E4|Reported Event|Normal Height Receiving Placebo|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692164|NCT01911260|E3|Reported Event|Normal Height+Zinc Amino Acid Chelate|"For the Normal Stature group (NS), HAZ was set up as being between -1 and +1 standard deviations from the mean height reference for age and sex.~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692165|NCT01911260|E2|Reported Event|Growth Deficit Receiving Placebo|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692166|NCT01911260|E1|Reported Event|Growth Deficit+Zinc Amino Acid Chelate|"Children with one and a half or more standard deviations below the mean height for age and gender of the reference population (Z-score under -1.6) were included in the Growth Deficit group (GD).~During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student."
692167|NCT01911221|B1|Baseline|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
692168|NCT01911221|P1|Participant Flow|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
692169|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692170|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692171|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692172|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692173|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692174|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692175|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692176|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692177|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692178|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692179|NCT01911221|O1|Outcome|rMenB+OMV NZ|Subjects received two doses of rMenB +OMV NZ vaccine at 0 and 2 month schedule.
692180|NCT01911221|E1|Reported Event|rMenB+OMVNZ|Subjects received two doses of rMenB +OMV NZ at 0 month and 2 month schedule.
692181|NCT01911065|B3|Baseline|Total|Total of all reporting groups
692182|NCT01911065|B2|Baseline|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
692183|NCT01911065|B1|Baseline|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
692184|NCT01911065|P2|Participant Flow|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
692185|NCT01911065|P1|Participant Flow|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
692433|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692186|NCT01911065|O2|Outcome|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
692187|NCT01911065|O1|Outcome|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
692188|NCT01911065|O2|Outcome|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
692189|NCT01911065|O1|Outcome|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
692190|NCT01911065|E2|Reported Event|Naturally-acquired VZV Immunity|Participants 40-49 years of age did not receive any intervention with the objective of examining the influence of age and inherited factors on the varicella zoster virus (VZV)-specific immune response in those with a naturally-acquired VZV immunity (a prior history of chicken pox).
692191|NCT01911065|E1|Reported Event|Zostavax™ Vaccine Group|Participants > 50 years received a single dose 0.65 ml Zostavax™ (live, attenuated zoster vaccine) administered by subcutaneous injection.
692192|NCT01910831|B1|Baseline|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
692193|NCT01910831|P1|Participant Flow|DerMend Moisturizing Bruise Formula vs. Vehicle Control|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula vs. Vehicle control."
692194|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
692195|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula"
692196|NCT01910831|O2|Outcome|LEFT Arm Randomized to Non-active Placebo Control|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
692197|NCT01910831|O1|Outcome|LEFT Arm Randomized to DerMend Moisturizing Bruise Formula|"Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.~DerMend Moisturizing Bruise Formula"
692198|NCT01910831|E1|Reported Event|All Participants|Apply LEFT treatment to LEFT arm or (vica versa) RIGHT treatment to RIGHT arm. Will not be known to the subject which arm is on the active treatment and which is on the placebo control. Applied twice daily for 12 weeks. Each subject will have one arm/hand that is either a)the experimental treatment or b) the placebo control.
692199|NCT01910792|B3|Baseline|Total|Total of all reporting groups
692200|NCT01910792|B2|Baseline|Group 1|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692201|NCT01910792|B1|Baseline|Group 2|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692202|NCT01910792|P2|Participant Flow|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692203|NCT01910792|P1|Participant Flow|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692204|NCT01910792|O2|Outcome|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692205|NCT01910792|O1|Outcome|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692206|NCT01910792|E2|Reported Event|Pts w/ Fat Malabsorption|"Patients with fat malabsorption syndromes will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692207|NCT01910792|E1|Reported Event|Pts w/ Gastric Bypass|"Patients who have had gastric bypass surgery will be exposed to a Sperti Lamp 3x/week~Sperti Lamp: UV light exposure 3 times per week for 12 weeks"
692208|NCT01910688|B1|Baseline|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
692227|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
700404|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
692209|NCT01910688|P1|Participant Flow|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
692210|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
692211|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
692212|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
692213|NCT01910688|O1|Outcome|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
692214|NCT01910688|E1|Reported Event|RFA Treatment (Radiofrequency Ablation)|"If eligible for enrollment, patients receive initial RFA treatment at 0 month. Patients return to the study site at 3.5 months to review weight data since initial RFA. If the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 4 months. All patients are seen at 7.5months and if the patient has not reached ideal body weight, the patient is scheduled for endoscopy with RFA at 8 months. All patients are seen at the study site at 12 months for final clinic weight.~RFA treatment: If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis."
692215|NCT01910636|B3|Baseline|Total|Total of all reporting groups
692216|NCT01910636|B2|Baseline|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
692217|NCT01910636|B1|Baseline|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
692218|NCT01910636|P2|Participant Flow|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
692219|NCT01910636|P1|Participant Flow|SOF+RBV Treatment Naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
692220|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
692221|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
692222|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
692223|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
692224|NCT01910636|O2|Outcome|SOF+RBV Treatment Experienced|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment experienced)
692225|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
692226|NCT01910636|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
692228|NCT01910636|O1|Outcome|SOF+RBV Treatment Naive|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks (treatment naive)
692229|NCT01910636|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (600-1000 mg daily based on weight) for 12 weeks
692230|NCT01910441|B3|Baseline|Total|Total of all reporting groups
692231|NCT01910441|B2|Baseline|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692232|NCT01910441|B1|Baseline|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692233|NCT01910441|P2|Participant Flow|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692234|NCT01910441|P1|Participant Flow|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692235|NCT01910441|O2|Outcome|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692236|NCT01910441|O1|Outcome|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692237|NCT01910441|E2|Reported Event|Group B: Glimepiride Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692238|NCT01910441|E1|Reported Event|Group A: Vildagliptin Plus Metformin|Participants received Vildagliptin 50 mg twice daily as an add-on to metformin (1000-1500mg daily).
692239|NCT01910402|B3|Baseline|Total|Total of all reporting groups
692240|NCT01910402|B2|Baseline|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692241|NCT01910402|B1|Baseline|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692242|NCT01910402|P2|Participant Flow|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692243|NCT01910402|P1|Participant Flow|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692244|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692245|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692246|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692247|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692248|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692249|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692250|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692251|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692252|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692334|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
700405|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
692253|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692254|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692255|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
692256|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692257|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692258|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692259|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692260|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692261|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692262|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692263|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692264|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692265|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692266|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692267|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated..
692268|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692269|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692270|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692426|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692271|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692272|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692273|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692274|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692275|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692276|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692277|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692278|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692279|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692280|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692281|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692282|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692283|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692284|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692285|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692286|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692287|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692288|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692427|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692289|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692290|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692291|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692292|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692293|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692294|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692295|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692296|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692297|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692298|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692299|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692300|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692301|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692302|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692303|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692304|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692305|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it wasi) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692306|NCT01910402|O2|Outcome|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692428|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692307|NCT01910402|O1|Outcome|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TC FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TC FDC was discontinued/terminated.
692308|NCT01910402|E2|Reported Event|ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD|Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks.
692309|NCT01910402|E1|Reported Event|DTG 50 mg/ABC 600 mg/3TC 300 mg QD|Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants on this arm who successfully completed the Randomized Phase were allowed access to DTG/ABC/3TD FDC in the Continuation Phase until it was i) locally approved and commercially available, or ii) the participant no longer derived clinical benefit or iii) the participant met a protocol-defined reason for discontinuation, or iv) development of DTG/ABC/3TD FDC was discontinued/terminated.
692310|NCT01910389|B3|Baseline|Total|Total of all reporting groups
692311|NCT01910389|B2|Baseline|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692312|NCT01910389|B1|Baseline|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692313|NCT01910389|P2|Participant Flow|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692314|NCT01910389|P1|Participant Flow|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692315|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692316|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692317|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692318|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692319|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692320|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692321|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692322|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692323|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692324|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692325|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692326|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692327|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692328|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692329|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692330|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692331|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692332|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692333|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692335|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692336|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692337|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692338|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692339|NCT01910389|O2|Outcome|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692340|NCT01910389|O1|Outcome|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692341|NCT01910389|E2|Reported Event|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
692342|NCT01910389|E1|Reported Event|Tadalafil|Tadalafil is supplied in 20 mg tablets. Subjects will take 20 mg (one tablet) once per day and will be titrated to 40 mg (two tablets once per day) after one week. Subjects are on study drug for the duration of the trial.
692343|NCT01910311|B1|Baseline|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
692344|NCT01910311|P1|Participant Flow|Baricitinib Then Baricitinib and Rifampicin|"Period 1: 10-milligram (mg) dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally once daily (QD) on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10."
692345|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
692346|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
692347|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with a coadministration of 10-mg dose of baricitinib on Day 10.
692348|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
692349|NCT01910311|O2|Outcome|Baricitinib and Rifampicin|Period 2: 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 11, with coadministration of a 10-mg dose of baricitinib on Day 10.
692350|NCT01910311|O1|Outcome|Baricitinib|Period 1: 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.
692351|NCT01910311|E3|Reported Event|Baricitinib and Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 10 and 11, with coadministration of a 10-mg dose of baricitinib on Day 10.~AEs are reported postdose on Day 10 up to Day 32."
692352|NCT01910311|E2|Reported Event|Rifampicin|"A 600-mg dose of rifampicin (2 x 300-mg capsules) administered orally QD on Days 3 through 9.~AEs are reported postdose on Day 3 through predose on Day 10."
692353|NCT01910311|E1|Reported Event|Baricitinib|"A 10-mg dose of baricitinib (2 x 4-mg and 1 x 2-mg tablets) administered orally on Day 1.~Adverse events (AEs) are reported from baseline through predose on Day 3."
692354|NCT01910181|B1|Baseline|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692355|NCT01910181|P1|Participant Flow|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 milligrams (mg) twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The Pharmacokinetic (PK) Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692356|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692357|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692358|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692359|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692360|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692361|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692362|NCT01910181|O1|Outcome|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692363|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692364|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692365|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692366|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692367|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692368|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692369|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692370|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692371|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692372|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692373|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692374|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692375|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692429|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692430|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692376|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692377|NCT01910181|O1|Outcome|Vemurafenib: PK Cohort|The PK Cohort was first to recruit. Vemurafenib was administered orally as 960 mg twice daily on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and from Day 28 until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation.
692378|NCT01910181|E1|Reported Event|Vemurafenib: All Participants|Participants were entered into the study into one of two cohorts. Vemurafenib was administered orally as 960 mg twice daily until progression, unacceptable toxicity, consent withdrawal, decision by the investigator or Sponsor, or protocol/eligibility violation. The PK Cohort received treatment on Days 1 to 21 (morning dose only on Day 21), with a drug holiday from Days 22 to 27, and resumed treatment on Day 28. The Expansion Cohort received the same regimen from Day 1 onward, without a drug holiday.
692379|NCT01910116|B3|Baseline|Total|Total of all reporting groups
692380|NCT01910116|B2|Baseline|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692381|NCT01910116|B1|Baseline|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692382|NCT01910116|P2|Participant Flow|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~Placebo"
692383|NCT01910116|P1|Participant Flow|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~Shinbaro"
692384|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692385|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692386|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692387|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692388|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692389|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692390|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692391|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692392|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692393|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692394|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692395|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692396|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692397|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692398|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692399|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692400|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692401|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692402|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692403|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692404|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692405|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692406|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692407|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692408|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692409|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692410|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692411|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692412|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692413|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692414|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692415|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692416|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692417|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692418|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692419|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692420|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692421|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692422|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692423|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692424|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692425|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692435|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692436|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692437|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692438|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692439|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692440|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692441|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692442|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692443|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692444|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692445|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692446|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692447|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692448|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692449|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692450|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692451|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692452|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692453|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692454|NCT01910116|O2|Outcome|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692455|NCT01910116|O1|Outcome|Shinbaro|"Shinbaro, 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692456|NCT01910116|E2|Reported Event|Placebo|"Placebo 2 capsules, twice daily, for 12 weeks.~observation for 4 weeks"
692457|NCT01910116|E1|Reported Event|Shinbaro|"GCSB-5 (Shinbaro), 2 capsules (300mg), twice daily, for 12 weeks~observation for 4 weeks"
692458|NCT01910064|B1|Baseline|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692459|NCT01910064|P1|Participant Flow|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692460|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692461|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692462|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692463|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692464|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692465|NCT01910064|O1|Outcome|GK530G|the fixed-dose combination gel of Adapalene and Benzoyl Peroxide
692466|NCT01910064|E1|Reported Event|GK530G|GK530G is the fixed-dose combination gel of Adapalene and Benzoyl Peroxide, BPO
692467|NCT01909804|B13|Baseline|Total|Total of all reporting groups
692468|NCT01909804|B12|Baseline|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692469|NCT01909804|B11|Baseline|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
692470|NCT01909804|B10|Baseline|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692471|NCT01909804|B9|Baseline|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
692472|NCT01909804|B8|Baseline|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692473|NCT01909804|B7|Baseline|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692474|NCT01909804|B6|Baseline|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692475|NCT01909804|B5|Baseline|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692476|NCT01909804|B4|Baseline|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692477|NCT01909804|B3|Baseline|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
692478|NCT01909804|B2|Baseline|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692479|NCT01909804|B1|Baseline|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
692480|NCT01909804|P12|Participant Flow|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692481|NCT01909804|P11|Participant Flow|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
692482|NCT01909804|P10|Participant Flow|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
694926|NCT01892163|B2|Baseline|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
692483|NCT01909804|P9|Participant Flow|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
692484|NCT01909804|P8|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692485|NCT01909804|P7|Participant Flow|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692486|NCT01909804|P6|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692487|NCT01909804|P5|Participant Flow|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692488|NCT01909804|P4|Participant Flow|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692489|NCT01909804|P3|Participant Flow|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
692490|NCT01909804|P2|Participant Flow|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692491|NCT01909804|P1|Participant Flow|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|Sofosbuvir (SOF) 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
692492|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692493|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
692494|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692495|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
692496|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692497|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692498|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692499|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692500|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692501|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
692502|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692503|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
692504|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692505|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
692506|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692507|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
692508|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692509|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692510|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692511|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692512|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692513|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
692514|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692515|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
692516|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
692517|NCT01909804|O3|Outcome|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
692518|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
692519|NCT01909804|O1|Outcome|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
692520|NCT01909804|O12|Outcome|SOF+VEL 100 mg + RBV (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692521|NCT01909804|O11|Outcome|SOF+VEL 100 mg (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
692522|NCT01909804|O10|Outcome|SOF+VEL 25 mg + RBV (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 1)
692523|NCT01909804|O9|Outcome|SOF+VEL 25 mg (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
692524|NCT01909804|O8|Outcome|SOF+VEL 100 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692525|NCT01909804|O7|Outcome|SOF+VEL 100 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692526|NCT01909804|O6|Outcome|SOF+VEL 25 mg + RBV (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 cirrhotic)
692527|NCT01909804|O5|Outcome|SOF+VEL 25 mg (GT3 Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3 cirrhotic)
692528|NCT01909804|O4|Outcome|SOF+VEL 100 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692529|NCT01909804|O3|Outcome|SOF+VEL 100 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3 non-cirrhotic)
692530|NCT01909804|O2|Outcome|SOF+VEL 25 mg + RBV (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotype 3 non-cirrhotic)
692531|NCT01909804|O1|Outcome|SOF+VEL 25 mg (GT3 Non-Cirrhotic)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 3 non-cirrhotic)
692532|NCT01909804|E4|Reported Event|SOF+VEL 100 mg + RBV|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
692533|NCT01909804|E3|Reported Event|SOF+VEL 100 mg|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
692534|NCT01909804|E2|Reported Event|SOF+VEL 25 mg + RBV|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks (genotypes 1 and 3)
692535|NCT01909804|E1|Reported Event|SOF+VEL 25 mg|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotypes 1 and 3)
692536|NCT01909778|B1|Baseline|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg and 240 mg.~A number of 12 entered patients with compensated liver cirrhosis was planned."
692537|NCT01909778|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, open-label, 2-period fixed-sequence trial to evaluate two single oral doses of Faldaprevir, separated by 14 days washout period. The dose levels were 120 mg first, 240 mg second.~A number of 12 entered patients with compensated liver cirrhosis was planned."
692538|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692539|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692540|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692541|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692542|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692543|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692544|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692545|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692546|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692547|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692548|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692549|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692550|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692551|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692552|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692553|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692554|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692555|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692556|NCT01909778|O2|Outcome|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692557|NCT01909778|O1|Outcome|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692558|NCT01909778|E2|Reported Event|High Dose of Faldaprevir (Period 2)|single dose of 240 mg Faldaprevir soft gel capsule after a wash-out period of at least 14 days.
692559|NCT01909778|E1|Reported Event|Low Dose of Faldaprevir (Period 1)|single dose of 120 mg Faldaprevir soft gel capsule.
692560|NCT01909713|B1|Baseline|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
692561|NCT01909713|P1|Participant Flow|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
692562|NCT01909713|O6|Outcome|I Liked the Lotion Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22). Subjects were only required to respond to this question if they had used a moisturizer previously.
692563|NCT01909713|O5|Outcome|I Would Keep Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
692564|NCT01909713|O4|Outcome|The Lotion Made my Skin Feel Soft|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
692565|NCT01909713|O3|Outcome|The Lotion Spread Easily on my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
692566|NCT01909713|O2|Outcome|The Lotion Smelled Good|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
692567|NCT01909713|O1|Outcome|I Liked Using the Lotion|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the moisturizer at study end (day 22).
692568|NCT01909713|O6|Outcome|I Liked the Face Wash Better Than What I Was Using Before|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22). Subjects were only required to respond to this question if they had used a face wash previously.
692569|NCT01909713|O5|Outcome|I Would Keep Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
692570|NCT01909713|O4|Outcome|The Face Wash Rinsed Easily Off my Skin|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
692571|NCT01909713|O3|Outcome|The Face Wash Made my Skin Feel Clean|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
692572|NCT01909713|O2|Outcome|The Face Wash Was Easy to Use|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
692573|NCT01909713|O1|Outcome|I Liked Using the Face Wash|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Patient satisfaction questions were asked for the face wash at study end (day 22).
692574|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from week 3.
692575|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3.This arm shows the results from week 1.
692576|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. Hydration as assessed using corneometry at baseline, week 1, and week 3. This arm shows the results from baseline.
692577|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 3.
692578|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days, TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from week 1.
692579|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days. TEWL was assessed at baseline, week 1, and week 3. This arm shows the results from baseline.
692580|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692581|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692582|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692583|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692584|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692585|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692586|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692587|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692588|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692589|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692590|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692591|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692592|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692593|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692594|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692595|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692596|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692597|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692598|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692599|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692600|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692601|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692602|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692603|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692604|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692605|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692606|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692607|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692608|NCT01909713|O4|Outcome|Worst Post Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the worst post baseline results for all time ponts collected.
692609|NCT01909713|O3|Outcome|Week 3|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 3.
692610|NCT01909713|O2|Outcome|Week 1|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from week 1.
692611|NCT01909713|O1|Outcome|Baseline|All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days and were assessed for tolerability at baseline, week 1, and week 3. This arm shows the results from baseline.
692612|NCT01909713|E1|Reported Event|Cetaphil® DermaControl™ Regimen.|"All subjects used Cetaphil® DermaControl™ Oil Control Foam Wash and Cetaphil® DermaControl™ Oil Control Moisturizer SPF 30 at least once daily for 22 days.~Facial Cleanser and Moisturizer SPF 30: Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30"
692613|NCT01909674|B3|Baseline|Total|Total of all reporting groups
692614|NCT01909674|B2|Baseline|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
692615|NCT01909674|B1|Baseline|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
692616|NCT01909674|P2|Participant Flow|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
692617|NCT01909674|P1|Participant Flow|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
692618|NCT01909674|O2|Outcome|Total Sleep Time (TST) Oronasal Mask|"Total Sleep Time (TST)~The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
692619|NCT01909674|O1|Outcome|Total Sleep Time - Nasal Mask|"Total Sleep Time (TST)~The amount of actually sleep time in a sleep episode; this time is equal to the total sleep episode less the awake time. TST is the total of all REM and NREM sleep in a sleep episode."
692620|NCT01909674|E2|Reported Event|Nasal Mask|"Initial administration of nasal CPAP mask~Switch CPAP mask type"
692621|NCT01909674|E1|Reported Event|Oronasal Mask|"Initial administration of oronasal CPAP mask~Switch CPAP mask type"
692622|NCT01909570|B3|Baseline|Total|Total of all reporting groups
692623|NCT01909570|B2|Baseline|Double Embryo Transfer|Transfer of two fresh embryos
692624|NCT01909570|B1|Baseline|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
692625|NCT01909570|P2|Participant Flow|Double Embryo Transfer|Transfer of two fresh embryos
692626|NCT01909570|P1|Participant Flow|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
692627|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
692628|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
692629|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
692630|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
692631|NCT01909570|O2|Outcome|Double Embryo Transfer|Transfer of two fresh embryos
692632|NCT01909570|O1|Outcome|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
692633|NCT01909570|E2|Reported Event|Double Embryo Transfer|Transfer of two fresh embryos
692634|NCT01909570|E1|Reported Event|Elective Single Embryo Transfer|Elective single embryo transfer plus single embryo cryotransfer in case of no fresh conception
692635|NCT01909466|B1|Baseline|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692636|NCT01909466|P2|Participant Flow|Deltoid/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the deltoid muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692637|NCT01909466|P1|Participant Flow|Gluteal/Deltoid|Participants were injected with aripiprazole IM depot 400 mg at the gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692638|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692639|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692640|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692641|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692642|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692643|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692644|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692645|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692646|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692647|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692648|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692649|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692650|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692651|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692652|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692653|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692654|NCT01909466|O1|Outcome|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692655|NCT01909466|E1|Reported Event|Aripiprazole IM Depot 400 mg - Total|Participants were injected with aripiprazole IM depot 400 mg at the deltoid/ gluteal muscle site on Day 1 and followed by 4 subsequent deltoid administrations every 28 days.
692656|NCT01909336|B4|Baseline|Total|Total of all reporting groups
692657|NCT01909336|B3|Baseline|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|"Group 3: 0.9% Saline in 5% dextrose (intravenous)~0.9% Saline in 5% dextrose: Isotonic Solutions 0.9% Saline in 5% dextrose"
692658|NCT01909336|B2|Baseline|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|"Group 2: 0.45% Saline in 5% dextrose (intravenous)~0.45% Saline in 5% dextrose: Hypotonic Solutions: 0.45% Saline in 5% dextrose"
692659|NCT01909336|B1|Baseline|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|"Group 1: 0.3% Saline in 3.3% dextrose (intravenous)~0.3% Saline in 3.3% dextrose: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose"
692660|NCT01909336|P3|Participant Flow|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
692661|NCT01909336|P2|Participant Flow|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
692662|NCT01909336|P1|Participant Flow|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
692663|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
692664|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
692665|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
692666|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
692667|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
692668|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
692669|NCT01909336|O3|Outcome|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
692670|NCT01909336|O2|Outcome|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
692671|NCT01909336|O1|Outcome|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
692672|NCT01909336|E3|Reported Event|Group 3: 0.9% Saline in 5% Dextrose (Intravenous)|Group 3: 0.9% Saline in 5% dextrose (intravenous): Isotonic Solutions
692673|NCT01909336|E2|Reported Event|Group 2: 0.45% Saline in 5% Dextrose (Intravenous)|Group 2: 0.45% Saline in 5% dextrose (intravenous): Hypotonic Solutions
692674|NCT01909336|E1|Reported Event|Group 1: 0.3% Saline in 3.3% Dextrose (Intravenous)|Group 1: 0.3% Saline in 3.3% dextrose (intravenous): Hypotonic Solutions
692675|NCT01909180|B1|Baseline|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
692676|NCT01909180|P1|Participant Flow|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
692677|NCT01909180|O3|Outcome|Neuro|Subjects receiving Revolution CT Scans of Brain or Spinal Cord
692678|NCT01909180|O2|Outcome|Body/ Extremity|Subject receiving a Revolution CT scan of the body or extremities
692679|NCT01909180|O1|Outcome|Cardiac|Subjects who received a cardiac CT scan
692680|NCT01909180|E1|Reported Event|Standard of Care Scan|"This is a single arm clinical trial.~Standard of care scan~Investigational Scan"
692681|NCT01909141|B3|Baseline|Total|Total of all reporting groups
692682|NCT01909141|B2|Baseline|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 will received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692683|NCT01909141|B1|Baseline|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692684|NCT01909141|P2|Participant Flow|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692685|NCT01909141|P1|Participant Flow|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692686|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692687|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692688|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692719|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692720|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
693103|NCT01904773|E4|Reported Event|Part 2 - AZD5213 0.5 mg|Part 2 - AZD5213, 0.5 mg periods (2-4 periods)
692689|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692690|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692691|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692692|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692693|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692694|NCT01909141|O2|Outcome|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692695|NCT01909141|O1|Outcome|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 receivde letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was be done for arm 1 for 3 consecutive cycles unless pregnancy occured.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was caculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692721|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692722|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
693104|NCT01904773|E3|Reported Event|Part 1 - AZD5213 2.0 mg|Part 1 - Days 6-8, AZD5213 2.0 mg
692696|NCT01909141|E2|Reported Event|Arm 2: Clomiphene Citrate-pioglitazone-metformin|"Arm 2 received clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using clomiphene citrate-pioglitazone-metformin: induction of ovulation for arm 2 was done in 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound was done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692697|NCT01909141|E1|Reported Event|Arm 1:Letrozole-pioglitazone -Metformin Group|"Arm 1 received letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.~induction of ovulation using letrozole-pioglitazone-metformin: induction of ovulation was done for arm 1 for 3 consecutive cycles unless pregnancy occurred.~transvaginal ultrasound: transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle~body mass index (BMI) calculation: BMI was calculated.~day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone: baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) were done for all women.~serum estradiol (E2) was done on day of hCG administration for all women.~serum progesterone on day 21 was done for all women."
692698|NCT01909011|B3|Baseline|Total|Total of all reporting groups
692699|NCT01909011|B2|Baseline|Sham CES|"The CES sham group will receive sham CES (device off)for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
692700|NCT01909011|B1|Baseline|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
692701|NCT01909011|P2|Participant Flow|Sham CES|"The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.~Sham CES via FW-100 Fisher Wallace Stimulator: The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks."
692702|NCT01909011|P1|Participant Flow|Active CES|"The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.~FW -100 Fisher Wallace Cranial Electrical Stimulator: The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks."
692703|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
692704|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
692705|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
692706|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
692707|NCT01909011|O2|Outcome|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks.
692708|NCT01909011|O1|Outcome|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for two weeks.
692709|NCT01909011|E2|Reported Event|Sham|Participants received sham CES (device off) for 20 minutes 5 times per week for two weeks (placebo period), and after cross-over into open-label phase participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for another two weeks.
692710|NCT01909011|E1|Reported Event|Active|Participants received 2 mA CES treatment for one 20 minute session per day, 5 times per week for four weeks.
692711|NCT01908842|B3|Baseline|Total|Total of all reporting groups
692712|NCT01908842|B2|Baseline|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: BNX sublingual film (open-label); Days 15-21: Switch to BNX sublingual tablets (open-label); Day 22: End of study visit
692713|NCT01908842|B1|Baseline|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded); Days 3-14: BNX sublingual tablets (open-label); Days 15-21: Switch to BNX sublingual film (open-label); Day 22: End of study visit
692714|NCT01908842|P2|Participant Flow|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
692715|NCT01908842|P1|Participant Flow|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3 to 14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692716|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
692717|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692718|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
692838|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692723|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692724|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
692725|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692726|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
692727|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692728|NCT01908842|O2|Outcome|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
692729|NCT01908842|O1|Outcome|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692730|NCT01908842|E2|Reported Event|Buprenorphine, Then OL BNX Film, Then BNX Tablets|Days 1-2: Buprenorphine sublingual tablets (blinded induction); Days 3-14: BNX sublingual film (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual tablets (open-label stabilization/maintenance); Day 22: End of study visit
692731|NCT01908842|E1|Reported Event|BNX Tablets, Then OL BNX Tablets, Then BNX Film|Days 1-2: BNX sublingual tablets (blinded induction); Days 3-14: BNX sublingual tablets (open-label stabilization/maintenance); Days 15-21: Switch to BNX sublingual film (open-label stabilization/maintenance); Day 22: End of study visit
692732|NCT01908803|B3|Baseline|Total|Total of all reporting groups
692733|NCT01908803|B2|Baseline|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
692734|NCT01908803|B1|Baseline|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
692735|NCT01908803|P2|Participant Flow|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
692736|NCT01908803|P1|Participant Flow|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
692737|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
692738|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
692739|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
692740|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
692741|NCT01908803|O2|Outcome|CIPRODEX|Four drops in affected ear(s) twice daily through tympanostomy tube for 7 days
692742|NCT01908803|O1|Outcome|AL-60371/AL-817|200 μL in affected ear(s) through tympanostomy tube on Day 1 (Visit 1)
692743|NCT01908803|E3|Reported Event|CIPRODEX|Includes all subjects administered a dose of CIPRODEX®
692744|NCT01908803|E2|Reported Event|AL-60371/AL-817|Includes all subjects administered a dose of AL-60371/AL-817
692745|NCT01908803|E1|Reported Event|Pre-treatment|Includes all subjects prior to administration of study medication
692746|NCT01908140|B3|Baseline|Total|Total of all reporting groups
692747|NCT01908140|B2|Baseline|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
692748|NCT01908140|B1|Baseline|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
692749|NCT01908140|P2|Participant Flow|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
692750|NCT01908140|P1|Participant Flow|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
692751|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
692752|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
692753|NCT01908140|O2|Outcome|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
692754|NCT01908140|O1|Outcome|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
692755|NCT01908140|E2|Reported Event|Salmeterol / Fluticasone|Active Comparator: Salmeterol / Fluticasone propionate Salmeterol 50 μg / Fluticasone propionate 500 μg BID for 24 Weeks
692756|NCT01908140|E1|Reported Event|Aclidinium Bromide / Formoterol Fumarate|Experimental: Aclidinium Bromide / Formoterol Fumarate Aclidinium Bromide 400 μg / Formoterol Fumarate 12 μg BID for 24 Weeks
692757|NCT01908127|B3|Baseline|Total|Total of all reporting groups
692839|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692840|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692841|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692842|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692843|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692758|NCT01908127|B2|Baseline|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692759|NCT01908127|B1|Baseline|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692760|NCT01908127|P2|Participant Flow|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692761|NCT01908127|P1|Participant Flow|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692762|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692763|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692764|NCT01908127|O2|Outcome|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692765|NCT01908127|O1|Outcome|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692766|NCT01908127|E2|Reported Event|Film Modelling|"Group II (Filmed modelling Group): the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.~In the second session, injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692767|NCT01908127|E1|Reported Event|Tell- Show- do Procedure|"Group I (Tell- Show- Do Group): Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant in the operation room.~In the second session,injection of loal anesthesia solution including a mandibular alveolar nerve block technique and the occlusal cavity preparation was performed."
692768|NCT01907906|B3|Baseline|Total|Total of all reporting groups
692769|NCT01907906|B2|Baseline|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49)
692770|NCT01907906|B1|Baseline|Arm 1: Mirasol-treated WB Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
692771|NCT01907906|P2|Participant Flow|Arm 2: Untreated WB Then Mirasol-treated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
692844|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692845|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692846|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692847|NCT01907906|E2|Reported Event|Untreated Control|LR-pRBCs derived from untreated WB
692848|NCT01907906|E1|Reported Event|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB.
692772|NCT01907906|P1|Participant Flow|Arm 1: Mirasol-treated Whole Blood (WB) Then Untreated WB|Screening Period (14 days); Treatment Period 1 (49 days): Donation of WB treated with Mirasol System for Whole Blood on Day 0, leuko-reduced packed red blood cells (LR-pRBCs) manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49); WB Donation Deferral Period (35-49 days); Treatment Period 2 (49 days): Donation of WB, UNTREATED on Day 0, LR-pRBCs manufactured & stored 21 days, radiolabeled RBCs reinfused on Day 21 and samples collected over 28 days (Days 21-49) Study Exit on Treatment Period 2, Day 49
692773|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692774|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692775|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692776|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692777|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692778|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692779|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692780|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692781|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692782|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692783|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692784|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692785|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692786|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692787|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692788|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692789|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692790|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692791|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692792|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692793|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692794|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692795|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692796|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692797|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692798|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692799|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692800|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692801|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692802|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692803|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692804|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692805|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692806|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692807|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692808|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692809|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692810|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692811|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692812|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692813|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692814|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692815|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692816|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692817|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692818|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692819|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692820|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692821|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692822|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692823|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692824|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692825|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692826|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692827|NCT01907906|O2|Outcome|Untreated Control|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from untreated WB
692828|NCT01907906|O1|Outcome|Mirasol Treated|Leuko-Reduced packed Red Blood Cells (LR-pRBCs) derived from Mirasol-treated WB
692829|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692830|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692831|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692832|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692833|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692834|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692835|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692836|NCT01907906|O1|Outcome|Mirasol Treated|LR-pRBCs derived from Mirasol-treated WB
692837|NCT01907906|O2|Outcome|Untreated Control|LR-pRBCs derived from untreated WB
692849|NCT01907854|B3|Baseline|Total|Total of all reporting groups
692850|NCT01907854|B2|Baseline|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692851|NCT01907854|B1|Baseline|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692852|NCT01907854|P2|Participant Flow|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692853|NCT01907854|P1|Participant Flow|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692854|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692855|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692856|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692857|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692858|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692859|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692860|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692861|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692862|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692863|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692864|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692865|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692866|NCT01907854|O2|Outcome|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692867|NCT01907854|O1|Outcome|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692868|NCT01907854|E2|Reported Event|Sitagliptin|Subjects in this arm received treatments for a duration of 26 weeks; OD sitagliptin tablets (100 mg) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose ≥1000 mg/day]) + OD s.c., injection of liraglutide placebo.
692869|NCT01907854|E1|Reported Event|Liraglutide|"Subjects in this arm received treatments for a duration of 26 weeks; once-daily (OD) liraglutide (s.c., [under the skin] injection 0.6 mg/day, with weekly dose escalations of 0.6 mg/day up to a maintenance dose of 1.8 mg/day) + metformin tablets (≥1500 mg/day [or documented maximum tolerated dose~≥1000 mg/day]) + OD sitagliptin placebo tablets."
692870|NCT01907516|B3|Baseline|Total|Total of all reporting groups
692871|NCT01907516|B2|Baseline|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
692872|NCT01907516|B1|Baseline|Cell Phone-internet First, the Voicemail|Cell phone-internet home glucose reporting system first
692873|NCT01907516|P2|Participant Flow|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first, then cell phone-internet
692874|NCT01907516|P1|Participant Flow|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first, then voicemail
692875|NCT01907516|O1|Outcome|Total Study Population|All study participants, includes those in cell phone-internet first, then voicemail and voicemail first, then cell phone-internet
692876|NCT01907516|O2|Outcome|Used Voicemail Method|Voicemail first, then cell phone-internet home glucose monitoring system
692877|NCT01907516|O1|Outcome|Used Confidant Method|Cell phone-internet home based glucose monitoring first, then conventional Voicemail system for home glucose reporting
692878|NCT01907516|E2|Reported Event|Voicemail First, Then Cell Phone-internet|Voicemail home blood glucose reporting first
692879|NCT01907516|E1|Reported Event|Cell Phone-internet First, Then Voicemail|Cell phone-internet home glucose reporting system first
692880|NCT01907490|B1|Baseline|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
692881|NCT01907490|P1|Participant Flow|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
692882|NCT01907490|O1|Outcome|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
692883|NCT01907490|E1|Reported Event|Ha44 Gel 0.74% w/w|Ha44 Gel 0.74% w/w Open label, one arm
692884|NCT01907334|B1|Baseline|All Participants|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg.
692885|NCT01907334|P2|Participant Flow|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
692886|NCT01907334|P1|Participant Flow|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
692887|NCT01907334|O1|Outcome|Increase in Airway Resistance After Methacholine|Participants were randomized to either Advair 100/50 mcg and Advair 100/50 mcg, then Advair 100/50 mcg and Flovent 100 mcg OR Advair 100/50 mcg and Flovent 100 mcg, then Advair 100/50 mcg and Advair 100/50 mcg. On each study day after treatment, methacholine challenge was performed to determine provocational concentration of methacholine which caused a 40% increase in resistance at 5 Hz (PC40R5).
692888|NCT01907334|E2|Reported Event|Advair and Flovent Diskuses, Then Advair and Advair Diskuses|"On treatment day one, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
692889|NCT01907334|E1|Reported Event|Advair and Advair Diskuses, Then Advair and Flovent Diskuses|"On treatment day one, Advair 100/50 mcg and Advair 100/50 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5.~On treatment day two, Advair 100/50 mcg and Flovent 100 mcg were administered in a blinded fashion. One hour after receiving the dose a methacholine challenge was performed to determine PC40R5. After PC40R5 was reached or a negative result after the highest methacholine concentration, 64 mg/mL, subjects inhaled albuterol through a valved holding chamber to reverse bronchoconstriction and their lung function was monitored until it returned to within 20% of that day's baseline R5."
692890|NCT01907321|B1|Baseline|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
692907|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
693105|NCT01904773|E2|Reported Event|Part 1 - AZD5213 0.5 mg|Part 1 - Day 1, AZD5213 0.5 mg
692891|NCT01907321|P1|Participant Flow|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, enabling airflow.~Measures performed on all subjects: Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system."
692892|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
692893|NCT01907321|O1|Outcome|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
692894|NCT01907321|E1|Reported Event|Expiratory Muscle Strength Training (EMST)|"Participants will complete 5 weeks of EMST training, 5 repetitions per set, 5 sets per day, 5 days per week.~Expiratory muscle strength training: Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure.~Measures: Capsaicin will be used to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, and expiratory phase airflow will be made.~Pulmonary function test: Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.~Fluoroscopic swallow study: Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA)."
692895|NCT01907113|B6|Baseline|Total|Total of all reporting groups
692896|NCT01907113|B5|Baseline|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692897|NCT01907113|B4|Baseline|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692898|NCT01907113|B3|Baseline|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692899|NCT01907113|B2|Baseline|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692900|NCT01907113|B1|Baseline|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692901|NCT01907113|P5|Participant Flow|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692902|NCT01907113|P4|Participant Flow|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692903|NCT01907113|P3|Participant Flow|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692904|NCT01907113|P2|Participant Flow|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692905|NCT01907113|P1|Participant Flow|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692906|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
693010|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692908|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692909|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692910|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692911|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692912|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692913|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692914|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692915|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692916|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692917|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692918|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692919|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692920|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692921|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692922|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692923|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692924|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692925|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692926|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692927|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692928|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692929|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692930|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692931|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692932|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
693054|NCT01905956|E2|Reported Event|Placebo|"2 capsules per dose, 3 times daily~Placebo"
692933|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692934|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692935|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692936|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692937|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692938|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692939|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692940|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692941|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692942|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692943|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692944|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692945|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692946|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692947|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692948|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692949|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692950|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692951|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692952|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692953|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692954|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692955|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692956|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692957|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
693055|NCT01905956|E1|Reported Event|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
692958|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692959|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692960|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692961|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692962|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692963|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692964|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692965|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692966|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692967|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692968|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692969|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692970|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692971|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692972|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692973|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692974|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692975|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692976|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692977|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692978|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692979|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692980|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692981|NCT01907113|O5|Outcome|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692982|NCT01907113|O4|Outcome|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
693056|NCT01905657|B4|Baseline|Total|Total of all reporting groups
692983|NCT01907113|O3|Outcome|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692984|NCT01907113|O2|Outcome|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692985|NCT01907113|O1|Outcome|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692986|NCT01907113|E5|Reported Event|Kidney Failure|Patients with kidney failure, i.e. patients requiring dialysis. Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration.
692987|NCT01907113|E4|Reported Event|Severe Renal Impairment|"Patients with severe renal impairment. Severe renal impairment was defined as a Glomerular filtration rate of less than 30 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692988|NCT01907113|E3|Reported Event|Moderate Renal Impairment|"Patients with type 2 diabetes and moderate renal impairment. Moderate renal impairment was defined as a Glomerular filtration rate of 30-59 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692989|NCT01907113|E2|Reported Event|Mild Renal Impairment|"Patients with type 2 diabetes and mild renal impairment. Mild renal impairment was defined as a Glomerular filtration rate of 60-89 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692990|NCT01907113|E1|Reported Event|Normal Renal Function|"Patients with type 2 diabetes and normal renal function. Normal renal function was defined as a Glomerular filtration rate of more than 90 mL/min/1.73 m².~Patients were administered once with 50 mg of Empagliflozin as a single dose by oral administration."
692991|NCT01906658|B5|Baseline|Total|Total of all reporting groups
692992|NCT01906658|B4|Baseline|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692993|NCT01906658|B3|Baseline|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692994|NCT01906658|B2|Baseline|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692995|NCT01906658|B1|Baseline|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692996|NCT01906658|P4|Participant Flow|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692997|NCT01906658|P3|Participant Flow|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692998|NCT01906658|P2|Participant Flow|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
692999|NCT01906658|P1|Participant Flow|Acthar 80 U (1.0 mL) Subcutaneous (SC) Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693000|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693001|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693002|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693003|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693004|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693005|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693006|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693007|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693008|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693009|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693100|NCT01904773|E7|Reported Event|Part 1 - Placebo|Part 1 - Placebo, Days 2-5, washout after 0.5 mg single dose
693101|NCT01904773|E6|Reported Event|Part 2 - Placebo|Part 2 - Placebo periods (2 periods)
693011|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693012|NCT01906658|O4|Outcome|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693013|NCT01906658|O3|Outcome|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693014|NCT01906658|O2|Outcome|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693015|NCT01906658|O1|Outcome|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693016|NCT01906658|E4|Reported Event|Acthar 16 U (0.2 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 16 U (0.2 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693017|NCT01906658|E3|Reported Event|Acthar 56 U (0.7 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 56 U (0.7 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693018|NCT01906658|E2|Reported Event|Acthar 24 U (0.3 mL) SC Daily|"Acthar (Repository Corticotropin Injection) 24 U (0.3 mL) SC daily~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693019|NCT01906658|E1|Reported Event|Acthar 80 U (1.0 mL) SC Twice Weekly|"Acthar (Repository Corticotropin Injection) 80 U (1.0 mL) SC twice weekly~Repository corticotropin injection: Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks"
693020|NCT01906515|B3|Baseline|Total|Total of all reporting groups
693021|NCT01906515|B2|Baseline|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
693022|NCT01906515|B1|Baseline|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
693023|NCT01906515|P2|Participant Flow|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
693024|NCT01906515|P1|Participant Flow|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
693025|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
693026|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm.~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
693027|NCT01906515|O2|Outcome|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
693028|NCT01906515|O1|Outcome|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
693029|NCT01906515|E2|Reported Event|Control Group|Control Group received standard anesthesia care including intraoperative blood sampling when estimated blood loss was ≥15% of total blood volume and transfusion when hemoglobin was ≤10 g/dL.
693030|NCT01906515|E1|Reported Event|SpHb Group.|"In the SpHb Group, the anesthesiologist was guided by the addition of SpHb monitoring.~Continuous non invasive hemoglobin monitoring arm~Continuous non invasive hemoglobin monitoring : Masimo radical pulse co oximetry"
693031|NCT01905956|B3|Baseline|Total|Total of all reporting groups
693032|NCT01905956|B2|Baseline|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693033|NCT01905956|B1|Baseline|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693034|NCT01905956|P2|Participant Flow|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693035|NCT01905956|P1|Participant Flow|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693036|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693037|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693038|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693039|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693040|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693041|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693042|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693043|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693044|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693045|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693046|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693047|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693048|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693049|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693050|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693051|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693052|NCT01905956|O2|Outcome|Placebo|"2 capsules per dose, 3 times daily~Placebo"
693053|NCT01905956|O1|Outcome|IQP-AK-102|"2 capsules per dose, three times daily~IQP-AK-102"
693057|NCT01905657|B3|Baseline|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693058|NCT01905657|B2|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693059|NCT01905657|B1|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693060|NCT01905657|P3|Participant Flow|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693061|NCT01905657|P2|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693062|NCT01905657|P1|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years.
693063|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693064|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693065|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693066|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693067|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693068|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693069|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693070|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693071|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693072|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693073|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693074|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693075|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693076|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693077|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693078|NCT01905657|O3|Outcome|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693079|NCT01905657|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693080|NCT01905657|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693081|NCT01905657|E3|Reported Event|Docetaxel 75 mg/m^2|Participants received docetaxel 75 mg/m^2 IV over 1 hour Q3W for up to 2 years. Participants who experienced disease progression, may have been eligible to crossover to receive pembrolizumab 2 mg/kg Q3W.
693082|NCT01905657|E2|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
693083|NCT01905657|E1|Reported Event|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
693084|NCT01904773|B1|Baseline|Overall Study|Part 1 & Part 2
693085|NCT01904773|P9|Participant Flow|Part 2- Seqence CBABCA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
693086|NCT01904773|P8|Participant Flow|Part 2 Sequence CABBAC|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
693087|NCT01904773|P7|Participant Flow|Part 2- Sequence BCACBA|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
693088|NCT01904773|P6|Participant Flow|Part 2- Sequence BACCAB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
693089|NCT01904773|P5|Participant Flow|Part 2- Sequence ACBABC|A= Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
693090|NCT01904773|P4|Participant Flow|Part 2 - Sequence ABCACB|A=Placebo, B=AZD5213 0.5 mg, C=AZD5213 2.0 mg
693091|NCT01904773|P3|Participant Flow|Part 2- Sequence BABBAB|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
693092|NCT01904773|P2|Participant Flow|Part 2 -Sequence BBABBA|B=AZD5213 0.5 mg, A=Placebo (did not tolerate 2.0 mg in Part 1)
693093|NCT01904773|P1|Participant Flow|Initial Study|Initial Screen, Part 1: AZD5213 0.5 mg single dose Day 1, AZD5213 2 mg dose Days 6-8
693094|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
693095|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
693096|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
693097|NCT01904773|O3|Outcome|Placebo|Part 2 - multiple 3 week treatment periods in a randomized 6- period crossover design
693098|NCT01904773|O2|Outcome|AZD5213 2.0 mg|Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
693099|NCT01904773|O1|Outcome|AZD5213 0.5 mg|Part 1 single dose, Part 2 - multiple 3 week treatment periods in a randomized 6 period crossover design
693108|NCT01904760|B2|Baseline|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
693109|NCT01904760|B1|Baseline|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
693110|NCT01904760|P2|Participant Flow|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
693111|NCT01904760|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
693112|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
693113|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
693114|NCT01904760|O2|Outcome|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
693115|NCT01904760|O1|Outcome|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
693116|NCT01904760|E2|Reported Event|Control|"Drug: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Saline placebo: Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day"
693117|NCT01904760|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.~Dexmedetomidine: Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day."
693118|NCT01904721|B8|Baseline|Total|Total of all reporting groups
693119|NCT01904721|B7|Baseline|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693120|NCT01904721|B6|Baseline|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693121|NCT01904721|B5|Baseline|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693122|NCT01904721|B4|Baseline|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
693123|NCT01904721|B3|Baseline|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
693124|NCT01904721|B2|Baseline|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
693125|NCT01904721|B1|Baseline|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
693126|NCT01904721|P7|Participant Flow|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693127|NCT01904721|P6|Participant Flow|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693128|NCT01904721|P5|Participant Flow|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693129|NCT01904721|P4|Participant Flow|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
693130|NCT01904721|P3|Participant Flow|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
693131|NCT01904721|P2|Participant Flow|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
693132|NCT01904721|P1|Participant Flow|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
693133|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693134|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693135|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693582|NCT01901341|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693136|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693137|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693138|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693139|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693140|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693141|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693142|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693143|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693144|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693145|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693146|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693147|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693148|NCT01904721|O3|Outcome|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693149|NCT01904721|O2|Outcome|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693150|NCT01904721|O1|Outcome|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693151|NCT01904721|E7|Reported Event|Stage 2: Bimatoprost Vehicle Twice Daily|Stage 2: Bimatoprost Vehicle applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693152|NCT01904721|E6|Reported Event|Stage 2: Bimatoprost Solution 1 Twice Daily|Stage 2: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693153|NCT01904721|E5|Reported Event|Stage 2: Bimatoprost Solution 2 Twice Daily|Stage 2: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 6 months.
693154|NCT01904721|E4|Reported Event|Stage 1: Bimatoprost Solution 2 Once Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp once daily for 28 days.
693155|NCT01904721|E3|Reported Event|Stage 1: Bimatoprost Solution 2 Twice Daily|Stage 1: Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
693156|NCT01904721|E2|Reported Event|Stage 1: Bimatoprost Solution 1 Once Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp once daily for 28 days.
693157|NCT01904721|E1|Reported Event|Stage 1: Bimatoprost Solution 1 Twice Daily|Stage 1: Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp twice daily for 28 days.
693158|NCT01905553|B3|Baseline|Total|Total of all reporting groups
693159|NCT01905553|B2|Baseline|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
693160|NCT01905553|B1|Baseline|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
693161|NCT01905553|P2|Participant Flow|SSP-004184SS Fasted First|Subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions on Day 1 in Treatment Period 1. During Treatment Period 2, subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast.
693162|NCT01905553|P1|Participant Flow|SSP-004184SS Fed First|Subjects received a single dose SSP-004184SS 21.8mg/kg on Day 1 administered 30 minutes after starting a standard high-fat, high-calorie breakfast in Treatment Period 1. During Treatment Period 2, subjects received a single-dose administration of 21.8mg/kg of SSP-004184SS under fasted conditions.
693163|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
693164|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
693165|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
693166|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
693167|NCT01905553|O2|Outcome|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
693168|NCT01905553|O1|Outcome|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
693169|NCT01905553|E2|Reported Event|SSP-004184SS (Fasted)|21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions.
693170|NCT01905553|E1|Reported Event|SSP-004184SS (Fed)|21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions.
693171|NCT01905540|B5|Baseline|Total|Total of all reporting groups
693172|NCT01905540|B4|Baseline|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
693173|NCT01905540|B3|Baseline|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
693174|NCT01905540|B2|Baseline|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
693175|NCT01905540|B1|Baseline|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
693176|NCT01905540|P4|Participant Flow|SS-AQ-SS2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
693177|NCT01905540|P3|Participant Flow|SS-AQ-AQ2|SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
693178|NCT01905540|P2|Participant Flow|AQ-SS-SS2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a morning and evening dose.
693179|NCT01905540|P1|Participant Flow|AQ-SS-AQ2|SSP-004184AQ 40mg/kg as a single dose, followed by SSP-004184SS 21.8mg/kg as a single dose, followed by SSP-004184AQ 40mg/kg as a morning and evening dose.
693180|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
693181|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
693182|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
693183|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
693184|NCT01905540|O2|Outcome|SSP-004184SS (2 Doses)|SSP-004184SS 21.8mg/kg morning and evening dose
693185|NCT01905540|O1|Outcome|SSP-004184AQ (2 Doses)|SSP-004184AQ 40mg/kg morning and evening dose.
693186|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
693187|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
693188|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
693189|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
693190|NCT01905540|O2|Outcome|SSP-004184SS (Single Dose)|21.8 mg/kg (oral capsule form) given once on Day 1
693191|NCT01905540|O1|Outcome|SSP-004184AQ (Single Dose)|40 mg/kg (oral capsule form) given once on Day 1
693192|NCT01905540|E4|Reported Event|SSP-004184SS (2 Doses)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered in the morning and 21.8mg/kg administered 12 hours later.
693193|NCT01905540|E3|Reported Event|SSP-004184AQ (2 Doses)|SP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered in the morning and 40mg/kg administered 12 hours later.
693194|NCT01905540|E2|Reported Event|SSP-004184SS (Single Dose)|SSP-004184SS: 21.8mg/kg (equivalent to 18.1mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
693195|NCT01905540|E1|Reported Event|SSP-004184AQ (Single Dose)|SSP-004184AQ: 40mg/kg (equivalent to 36.2mg/kg free-acid dose) administered as a single dose in a fasted state in the morning.
693196|NCT01905254|B1|Baseline|Single Arm Study|Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.
693197|NCT01905254|P1|Participant Flow|Transient Elastography and Liver Biopsy|"Transient elastography was performed by two experienced investigators using a FibroScan (EchoSens, Paris, France), the median value of liver stiffness measurements was recorded in kilopascals (kPa).~Liver biopsy was carried out within 3 months of TE. Liver biopsies from the right and left lobe were obtained under laparoscopic control using the Tru-cut 16 GAUGE needle (Bard monopty; Bard biopsy systems, Tempe, USA).~Data analysis was performed on the remaining 34 patients (female: 28 (82%); male: 6 (18 %).~Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in."
693198|NCT01905254|O1|Outcome|Transient Elastography in Autoimmune Hepatitis|Liver stiffness (kPa) was correlated to histologic staging of liver cirrhosis
693199|NCT01905254|E1|Reported Event|TE in Autoimmune Hepatitis|"Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.~There were no adverse events."
693200|NCT01904604|B4|Baseline|Total|Total of all reporting groups
693201|NCT01904604|B3|Baseline|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693202|NCT01904604|B2|Baseline|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693222|NCT01904279|B2|Baseline|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693223|NCT01904279|B1|Baseline|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693224|NCT01904279|P2|Participant Flow|TCZ SC 162 mg Q2W|Participants with body weight greater than or equal to (>/=) 30 kg were administered 162 mg of TCZ as an SC injection every 2 weeks (Q2W) for 52 weeks.
700406|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
693203|NCT01904604|B1|Baseline|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
693204|NCT01904604|P3|Participant Flow|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693205|NCT01904604|P2|Participant Flow|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693206|NCT01904604|P1|Participant Flow|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
693207|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693208|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693209|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
693210|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693211|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693212|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
693213|NCT01904604|O2|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693214|NCT01904604|O1|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693215|NCT01904604|O3|Outcome|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693216|NCT01904604|O2|Outcome|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693217|NCT01904604|O1|Outcome|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
693218|NCT01904604|E3|Reported Event|250 µg Peanut Patch|"Subjects apply high-dose DBV712 Viaskin® patch containing 250 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC continue active treatment with a high-dose DBV712 Viaskin® patch for a total active treatment period of 30 months (130 weeks).~High-dose DBV712 Viaskin® Patch: 250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693219|NCT01904604|E2|Reported Event|100 µg Peanut Patch|"Subjects apply low-dose DBV712 Viaskin® patch containing 100 micrograms (μg) peanut protein daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an OFC and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using same 21-day graduated dosing period used in blinded phase for subjects 4-<6 years old at enrollment or who had Grade 2 reaction or higher within previous 2 months) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Low-dose DBV712 Viaskin® Patch: 100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours."
693220|NCT01904604|E1|Reported Event|Placebo Patch|"Subjects apply placebo Viaskin® patch daily for a 52-week blinded period. Patch application duration is initially 3 hours and gradually increased to 24 hours over a 21-day graduated dosing period; subsequently patch changed every 24 hours. At Week 52, subjects complete an oral food challenge (OFC) and are unblinded. Following blinded phase, subjects who have not demonstrated sustained unresponsiveness at the Week 52 OFC crossover to active treatment (using the same 21-day graduated dosing period used in the blinded phase) and dose with a high-dose DBV712 Viaskin® patch containing 250 μg peanut protein for a total active treatment period of 30 months (130 weeks).~Placebo Viaskin® Patch: Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours."
693225|NCT01904279|P1|Participant Flow|TCZ SC 162 mg Q3W|Participants with body weight less than (<) 30 kilograms (kg) were administered 162 milligrams (mg) of TCZ as an subcutaneous (SC) injection every 3 weeks (Q3W) for 52 weeks.
693226|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693227|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693228|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 Weeks.
693229|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693230|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693231|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693232|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693233|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693234|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693235|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693236|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693237|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693238|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693239|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693240|NCT01904279|O2|Outcome|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693241|NCT01904279|O1|Outcome|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693242|NCT01904279|E2|Reported Event|TCZ SC 162 mg Q2W|Participants with body weight >/= 30 kg were administered 162 mg of TCZ as an SC injection Q2W for 52 weeks.
693243|NCT01904279|E1|Reported Event|TCZ SC 162 mg Q3W|Participants with body weight < 30 kg were administered 162 mg of TCZ as an SC injection Q3W for 52 weeks.
693244|NCT01904149|B7|Baseline|Total|Total of all reporting groups
693245|NCT01904149|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
693246|NCT01904149|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
693247|NCT01904149|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
693248|NCT01904149|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
693249|NCT01904149|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
693250|NCT01904149|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
693251|NCT01904149|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
693252|NCT01904149|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
693253|NCT01904149|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
693254|NCT01904149|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
693255|NCT01904149|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
693256|NCT01904149|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
693257|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
693258|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
693259|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
693260|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
693261|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 3 days (a total of 6 doses)
693262|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (a total of 6 doses)
693263|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours); Drug: Placebo single oral dose (first 8 hours) Arm type: placebo comparator; placebo single oral dose (first 8 hours)
693264|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
693265|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
693266|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
693267|NCT01904149|O4|Outcome|PLACEBO|Drug: Placebo single oral dose (first 8 hours) Arm type: Placebo comparator; Placebo single oral dose (first 8 hours)
693268|NCT01904149|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours) Arm type: active comparator; Tramadol single oral dose (first 8 hours)
693269|NCT01904149|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours) Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours)
693270|NCT01904149|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours) Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours)
693271|NCT01904149|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
693272|NCT01904149|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
693273|NCT01904149|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
693274|NCT01904149|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
693275|NCT01904149|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
693276|NCT01904149|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
693277|NCT01904071|B4|Baseline|Total|Total of all reporting groups
693278|NCT01904071|B3|Baseline|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693279|NCT01904071|B2|Baseline|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693280|NCT01904071|B1|Baseline|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693281|NCT01904071|P3|Participant Flow|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693282|NCT01904071|P2|Participant Flow|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693283|NCT01904071|P1|Participant Flow|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693284|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693285|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693286|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693287|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693288|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693289|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693290|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693291|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693292|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693293|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693415|NCT01903265|B3|Baseline|Total|Total of all reporting groups
700407|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
693294|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693295|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693296|NCT01904071|O3|Outcome|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693297|NCT01904071|O2|Outcome|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693298|NCT01904071|O1|Outcome|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693299|NCT01904071|E3|Reported Event|IVMS|"IV Morphine: IV Morphine patients were also monitored for a minimum of one hour after they were given a second dose of IV morphine, 0.1 mg/kg, once the radiographs demonstrated fracture. The control group was also eligible to receive rescue analgesia of an additional 0.1 mg/kg of IV morphine, followed by repeat doses of 0.05 mg/kg~IVMS (IV Morphine)"
693300|NCT01904071|E2|Reported Event|UFIB|"Ultrasound Guided Fascia Iliaca Compartment Block: For the UFIB, the two fascial planes, the fascia lata and the fascia iliaca, were sonographically visualized with the probe transverse to the thigh just inferior to the inguinal ligament and one-third of the distance from the anterior superior iliac spine to the pubic tubercle.~UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)"
693301|NCT01904071|E1|Reported Event|UFNB|"Ultrasound guided 3 in 1 femoral nerve block: The UFNB was performed by first visualizing the femoral nerve in a transverse orientation just inferior to the inguinal ligament and lateral to the common femoral artery.~UFNB (Ultrasound guided femoral nerve block)"
693302|NCT01904058|B5|Baseline|Total|Total of all reporting groups
693303|NCT01904058|B4|Baseline|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693304|NCT01904058|B3|Baseline|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693305|NCT01904058|B2|Baseline|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693306|NCT01904058|B1|Baseline|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693307|NCT01904058|P4|Participant Flow|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693308|NCT01904058|P3|Participant Flow|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693309|NCT01904058|P2|Participant Flow|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693310|NCT01904058|P1|Participant Flow|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693311|NCT01904058|O4|Outcome|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
693312|NCT01904058|O3|Outcome|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
693313|NCT01904058|O2|Outcome|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
693314|NCT01904058|O1|Outcome|LUM001 5 mg + UDCA|Participants received LUM001 5 milligram (mg) tablet orally once daily for a period of 13 weeks in combination with UDCA.
693315|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693316|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693448|NCT01903148|B1|Baseline|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693317|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693318|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693319|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693320|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693321|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693322|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693323|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693324|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693325|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693326|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693327|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693328|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693329|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693330|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693331|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693332|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693333|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693334|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693335|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693336|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
730100|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
693337|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693338|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A)|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693339|NCT01904058|O4|Outcome|Placebo + UDCA (Cohort B)|In Cohort B, participants received placebo (matched to LUM001) for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693340|NCT01904058|O3|Outcome|Placebo + UDCA (Cohort A)|In Cohort A, participants received placebo (matched to LUM001) once daily for a period of 13 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693341|NCT01904058|O2|Outcome|LUM001 20 mg + UDCA (Cohort B)|In Cohort B, participants received LUM001 tablets in combination with UDCA orally once daily at a dosage of 2.5 mg up to a maximum of 20 mg during the dose-escalation period over a 4 week period. Thereafter, participants received LUM001 20 mg (2x10 mg) tablet orally once daily for another 9 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693342|NCT01904058|O1|Outcome|LUM001 10 mg + UDCA (Cohort A|In Cohort A, participants received LUM001 tablet in combination with ursodeoxycholic acid (UDCA) orally once daily at a dosage of 2.5 up to a maximum of 10 milligram (mg) during the dose-escalation period over a 3 week period. Thereafter, participants received LUM001 10 mg tablet along with one placebo matched to LUM001 orally once daily for another 10 weeks, in combination with UDCA. Participants continued UDCA alone for an additional period of 4 weeks.
693343|NCT01904058|E4|Reported Event|Placebo + UDCA|Participants received placebo matched to LUM001 tablet orally once daily for a period of 13 weeks in combination with UDCA.
693344|NCT01904058|E3|Reported Event|LUM001 20 mg + UDCA|Participants received LUM001 20 mg (2x 10 mg) tablet for 20 mg daily dose in combination with UDCA orally once daily for a period of 13 weeks.
693345|NCT01904058|E2|Reported Event|LUM001 10 mg + UDCA|Participants received LUM001 10 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
693346|NCT01904058|E1|Reported Event|LUM001 5 mg + UDCA|Participants received LUM001 5 mg tablet orally once daily for a period of 13 weeks in combination with UDCA.
693347|NCT01903993|B3|Baseline|Total|Total of all reporting groups
693348|NCT01903993|B2|Baseline|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693349|NCT01903993|B1|Baseline|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
693350|NCT01903993|P2|Participant Flow|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693351|NCT01903993|P1|Participant Flow|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
693352|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693353|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693354|NCT01903993|O1|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693355|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693356|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
693357|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693358|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
693359|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693360|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
693361|NCT01903993|O2|Outcome|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693362|NCT01903993|O1|Outcome|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
693363|NCT01903993|E2|Reported Event|Atezolizumab|Participants were administered atezolizumab intravenously on Day 1 of each 21 day cycle at a fixed dose of 1200 mg. Atezolizumab treatment were to continued as long as participants were experiencing clinical benefit as assessed by the investigator.
693364|NCT01903993|E1|Reported Event|Docetaxel|Participants received docetaxel 75 milligram per squared meters (mg/m^2) administered intravenously on Day 1 of each 21 day cycle until disease progression or unacceptable toxicity or death.
693365|NCT01903876|B3|Baseline|Total|Total of all reporting groups
693366|NCT01903876|B2|Baseline|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
693367|NCT01903876|B1|Baseline|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
693368|NCT01903876|P2|Participant Flow|Bystander & Sexual Violence Prevention|A 3-hour web-based program designed to teach male college student bystanders to intervene.
693369|NCT01903876|P1|Participant Flow|General Health Promotion|A 3-hour general mental health web-based program.
693370|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
693371|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
693372|NCT01903876|O2|Outcome|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
693373|NCT01903876|O1|Outcome|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
693374|NCT01903876|E2|Reported Event|Bystander & Sexual Violence Prevention|"A 3-hour web-based program designed to teach male college student bystanders to intervene.~Bystander & Sexual Violence Prevention: This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place."
693375|NCT01903876|E1|Reported Event|General Health Promotion|"A 3-hour general mental health web-based program.~General Health Promotion: This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
693376|NCT01903720|B1|Baseline|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693377|NCT01903720|P1|Participant Flow|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693378|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693379|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693380|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693381|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693382|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693383|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693384|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693449|NCT01903148|P1|Participant Flow|Patients With Anemia and CKD|Adults patients with anemia secondary to chronic kidney disease (CKD) not on dialysis.
693385|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693386|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693387|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693388|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693389|NCT01903720|O1|Outcome|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693390|NCT01903720|E1|Reported Event|OZURDEX®|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
693391|NCT01903460|B5|Baseline|Total|Total of all reporting groups
693392|NCT01903460|B4|Baseline|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693393|NCT01903460|B3|Baseline|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693394|NCT01903460|B2|Baseline|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
693395|NCT01903460|B1|Baseline|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
693396|NCT01903460|P4|Participant Flow|Placebo Cohort B|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693397|NCT01903460|P3|Participant Flow|Placebo Cohort A|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693398|NCT01903460|P2|Participant Flow|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
693399|NCT01903460|P1|Participant Flow|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
693400|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693401|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
693402|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
693403|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
693404|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693405|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
693406|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
693407|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
693408|NCT01903460|O4|Outcome|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693409|NCT01903460|O3|Outcome|LUM001 Overall|Participants received either dose of LUM001 for up to 10 or 13 weeks, then were followed for 4 weeks after treatment.
693410|NCT01903460|O2|Outcome|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
693411|NCT01903460|O1|Outcome|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
693412|NCT01903460|E3|Reported Event|Placebo Overall|Participants received LUM001-matching placebo for up to 13 weeks, then were followed for 4 weeks after treatment.
693413|NCT01903460|E2|Reported Event|LUM001 280ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 280ug/kg/day, then received 8 to 10 weeks of treatment at either 280ug/kg/day or the highest tolerated dose below 280ug/kg/day. Participants were then followed for 4 weeks after treatment.
693414|NCT01903460|E1|Reported Event|LUM001 140ug/kg/Day|Participants received an escalating dose of LUM001 over 3 to 5 weeks, from 14ug/kg/day to 140ug/kg/day, then received 8 to 10 weeks of treatment at either 140ug/kg/day or the highest tolerated dose below 140ug/kg/day. Participants were then followed for 4 weeks after treatment.
693416|NCT01903265|B2|Baseline|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks. (One patient randomized in error never received study drug and therefore is not included in this table.)"
693417|NCT01903265|B1|Baseline|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693418|NCT01903265|P2|Participant Flow|Placebo|1 tablet of placebo sublingually each day at bedtime for 12 weeks.
693419|NCT01903265|P1|Participant Flow|TNX-102 SL 2.8 mg|1 tablet of TNX-102 SL sublingually each day at bedtime for 12 weeks
693420|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693421|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693422|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693423|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693424|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693425|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693426|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693427|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693428|NCT01903265|O2|Outcome|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693429|NCT01903265|O1|Outcome|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693430|NCT01903265|E2|Reported Event|Placebo|"1 x Placebo Tablet taken sublingually each day at bedtime for 12 weeks.~Placebo: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693431|NCT01903265|E1|Reported Event|TNX-102 SL 2.8 mg Tablets|"1 x TNX-102 SL 2.8mg Tablet taken sublingually each day at bedtime for 12 weeks.~TNX-102 SL 2.8mg Tablets: Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks."
693432|NCT01903187|B3|Baseline|Total|Total of all reporting groups
693433|NCT01903187|B2|Baseline|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
693434|NCT01903187|B1|Baseline|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693435|NCT01903187|P2|Participant Flow|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
693436|NCT01903187|P1|Participant Flow|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693437|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693438|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693439|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693440|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693441|NCT01903187|O2|Outcome|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram"
693442|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693443|NCT01903187|O1|Outcome|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693444|NCT01903187|E2|Reported Event|Sham Procedure|"Sham procedure~Sham: Renal artery angiogram~Subjects exited after 1 month follow up"
693445|NCT01903187|E1|Reported Event|Renal Denervation|"Renal artery ablation with the EnligHTN™ Renal Denervation System.~EnligHTN Renal Denervation: Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system"
693446|NCT01903148|B3|Baseline|Total|Total of all reporting groups
693447|NCT01903148|B2|Baseline|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693579|NCT01901393|E1|Reported Event|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693450|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693451|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693452|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693453|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693454|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693455|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693456|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693457|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693458|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693459|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693460|NCT01903148|O2|Outcome|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693461|NCT01903148|O1|Outcome|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693462|NCT01903148|E2|Reported Event|Naïve Patients|Patients starting anemia treatment (naïve) after six months of the last recommendations of the Anemia Working Group of ERBP (January 2011)
693463|NCT01903148|E1|Reported Event|Converted Patients|Patients in treatment who changed from previous ESA treatment since January 2011
693464|NCT01903005|B3|Baseline|Total|Total of all reporting groups
693465|NCT01903005|B2|Baseline|OX219-007 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693466|NCT01903005|B1|Baseline|OX219-006 Completers|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg and 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693467|NCT01903005|P1|Participant Flow|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693468|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693469|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693470|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693471|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693472|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693473|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693474|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693475|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693476|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693477|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693478|NCT01903005|O1|Outcome|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses ranging from 5.7/1.4 mg to 17.1/4.2 mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693479|NCT01903005|E1|Reported Event|Safety Population|Weeks 1-24: Higher bioavailability BNX sublingual tablets (open-label) were titrated at doses of buprenorphine/naloxone between 5.7/1.4 mg and 17.1/4.2 mg mg, to a dose that relieved opioid cravings and withdrawal symptoms with minimal side effects.
693480|NCT01902888|B1|Baseline|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
693481|NCT01902888|P1|Participant Flow|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
693482|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
693483|NCT01902888|O1|Outcome|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
693484|NCT01902888|E1|Reported Event|Popliteal Aneurysm|"GORE® VIABAHN® Endoprosthesis used to treat popliteal aneurysm~GORE® VIABAHN® Endoprosthesis"
693485|NCT01902758|B3|Baseline|Total|Total of all reporting groups
693486|NCT01902758|B2|Baseline|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
693487|NCT01902758|B1|Baseline|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
693488|NCT01902758|P2|Participant Flow|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
693489|NCT01902758|P1|Participant Flow|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
693490|NCT01902758|O2|Outcome|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
693491|NCT01902758|O1|Outcome|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
693492|NCT01902758|E2|Reported Event|Placebo|"matched placebo tablets wil be given at the same time to the comparison group as the medications to the experimental group~placebo: placebo for comparison group"
693493|NCT01902758|E1|Reported Event|Ambrisentan and Theophylline|"ambrisentan (5mg) once daily for 2 consecutive days theophylline (400mg) once daily for 2 consecutive days~ambrisentan and theophylline"
693494|NCT01902303|B3|Baseline|Total|Total of all reporting groups
693495|NCT01902303|B2|Baseline|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and received active test article
693496|NCT01902303|B1|Baseline|Matching Placebo|Placebo Safety Population - All subjects enrolled and received placebo test article
693497|NCT01902303|P2|Participant Flow|BTL-TML-HSV|"Experimental Product~BTL-TML-HSV: Sublingual micro dosing of BTL-TML-HSV for 7 days~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 – Take 1 drop six times daily –~Days 3-7 – Take one drop twice daily"
693498|NCT01902303|P1|Participant Flow|Matching Placebo|"Matching Placebo~Treatment regimens will be as follows (upon the first signs/symptoms of prodrome (tingling, itching, burning):~Day 0 – Take 1 drop every 10 minutes for the 1st hour following appearance of prodrome symptoms (0, 10, 20, 30, 40, 50 and 60 minutes), then 1 drop every hour until bedtime.~Days 1 & 2 – Take 1 drop six times daily –~Days 3-7 – Take one drop twice daily"
693499|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects who received active test article and were compliant with protocol
693500|NCT01902303|O1|Outcome|Matching Placebo|Placebo efficacy Population - All subjects who received placebo test article and were compliant with protocol
693501|NCT01902303|O2|Outcome|BTL-TML-HSV Active Treatment|BTL-TML Efficacy Population - All subjects enrolled and received active test article and met Per Protocol definition
693502|NCT01902303|O1|Outcome|Matching Placebo|Placebo Efficacy Population - All subjects enrolled and received placebo test article and met Per protocol definition
693503|NCT01902303|E2|Reported Event|BTL-TML-HSV Active Treatment|BTL-TML Safety Population - All subjects enrolled and allocated to active test article except for SAEs which includes all subjects that signed informed consent.
693504|NCT01902303|E1|Reported Event|Matching Placebo|Placebo Safety Population - All subjects that enrolled and were allocated to placebo test article except for SAEs and that includes all subjects that signed informed consent.
693505|NCT01902134|B7|Baseline|Total|Total of all reporting groups
693506|NCT01902134|B6|Baseline|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
693507|NCT01902134|B5|Baseline|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses
693508|NCT01902134|B4|Baseline|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
693509|NCT01902134|B3|Baseline|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
693510|NCT01902134|B2|Baseline|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
693511|NCT01902134|B1|Baseline|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
693512|NCT01902134|P6|Participant Flow|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses
693513|NCT01902134|P5|Participant Flow|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses Placebo followed by DKP
693514|NCT01902134|P4|Participant Flow|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses
693515|NCT01902134|P3|Participant Flow|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses
693516|NCT01902134|P2|Participant Flow|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses
693517|NCT01902134|P1|Participant Flow|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses
693518|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose during single dose phase (first 8 hours);
693519|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
693520|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
693521|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
693522|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
693523|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
693580|NCT01901341|B3|Baseline|Total|Total of all reporting groups
693524|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
693525|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol multiple doses; Arm type: active comparator; Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
693526|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen multiple doses; Arm type: active comparator; Dexketoprofen multiple oral doses t.i.d. for 5 days (a total of 12 doses)
693527|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol multiple doses; Arm type: experimental; Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (a total of 12 doses)
693528|NCT01902134|O4|Outcome|PLACEBO|Drug: Placebo; Arm type: PLACEBO comparator; Placebo single oral dose (first 8 hours);
693529|NCT01902134|O3|Outcome|TRAMADOL|Drug: Tramadol single oral dose (first 8 hours); Arm type: active comparator; Tramadol single oral dose (first 8 hours);
693530|NCT01902134|O2|Outcome|DEXKETOPROFEN|Drug: Dexketoprofen single oral dose (first 8 hours); Arm type: active comparator; Dexketoprofen single oral dose (first 8 hours);
693531|NCT01902134|O1|Outcome|DKP/TRAM|Drug: Dexketoprofen/Tramadol single oral dose (first 8 hours); Arm type: experimental; Dexketoprofen/Tramadol single oral dose (first 8 hours);
693532|NCT01902134|E6|Reported Event|Placebo Followed by TRAM|Placebo single dose followed by Tramadol-multiple doses.
693533|NCT01902134|E5|Reported Event|Placebo Followed by DKP|Placebo single dose followed by Dexketoprofen-multiple doses.
693534|NCT01902134|E4|Reported Event|Placebo Followed by DKP/TRAM|Placebo single dose followed by Dexketoprofen/Tramadol-multiple doses.
693535|NCT01902134|E3|Reported Event|TRAM Followed by TRAM|Tramadol-single dose followed by Tramadol-multiple doses.
693536|NCT01902134|E2|Reported Event|DKP Followed by DKP|Dexketoprofen-single dose followed by Dexketoprofen-multiple doses.
693537|NCT01902134|E1|Reported Event|DKP/TRAM Followed by DKP/TRAM|Dexketoprofen/Tramadol-single dose followed by Dexketoprofen/Tramadol-multiple doses.
693538|NCT01901588|B3|Baseline|Total|Total of all reporting groups
693539|NCT01901588|B2|Baseline|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693540|NCT01901588|B1|Baseline|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693541|NCT01901588|P2|Participant Flow|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693542|NCT01901588|P1|Participant Flow|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693543|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693544|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693545|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693546|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693547|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693548|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693549|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693550|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693551|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693552|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693553|NCT01901588|O2|Outcome|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693554|NCT01901588|O1|Outcome|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693555|NCT01901588|E2|Reported Event|Placebo|"patients receive saline solution.~Placebo: intraoperative dose of intravenous placebo"
693556|NCT01901588|E1|Reported Event|Dexmedetomidine|"dexmedetomidine/precedex~Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes"
693557|NCT01901575|B1|Baseline|Remifentanil|Remifentanil IV PCA
693558|NCT01901575|P1|Participant Flow|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
693559|NCT01901575|O1|Outcome|Remifentanil IV PCA|"patients with PVC's prior to administration of remifentanil~Remifentanil: Patients with established PVC's , sedated with remifentanil IVPCA per study protocol"
693560|NCT01901575|E1|Reported Event|Remifentanil IV PCA|Patients with established PVC's sedated with remifentanil IVPCA per study protocol
693561|NCT01901393|B3|Baseline|Total|Total of all reporting groups
693562|NCT01901393|B2|Baseline|Ketorolac|"30mg ketorolac~Ketorolac"
693563|NCT01901393|B1|Baseline|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693564|NCT01901393|P2|Participant Flow|Ketorolac|"30mg ketorolac~Ketorolac"
693565|NCT01901393|P1|Participant Flow|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693566|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
693567|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693568|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
693569|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693570|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
693571|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693572|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
693573|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693574|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
693575|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693576|NCT01901393|O2|Outcome|Ketorolac|"30mg ketorolac~Ketorolac"
693577|NCT01901393|O1|Outcome|IV Ibuprofen|"800mg ibuprofen~IV ibuprofen"
693578|NCT01901393|E2|Reported Event|Ketorolac|"30mg ketorolac~Ketorolac"
693583|NCT01901341|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
693584|NCT01901341|P1|Participant Flow|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693585|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693586|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693587|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693588|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693589|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693590|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693591|NCT01901341|O2|Outcome|Placebo|Placebo administered orally BID for a12-week treatment period
693592|NCT01901341|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693593|NCT01901341|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
693594|NCT01901341|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693595|NCT01901328|B3|Baseline|Total|Total of all reporting groups
693596|NCT01901328|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
693597|NCT01901328|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693598|NCT01901328|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
693599|NCT01901328|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice dailly (BID) for a 12-week treatment period
693600|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693601|NCT01901328|O1|Outcome|CB-5945|0.25 milligrams CB-5945 administered orally BID for a 12-week treatment period
693602|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693603|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693604|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693605|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693606|NCT01901328|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693607|NCT01901328|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693608|NCT01901328|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
693609|NCT01901328|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693610|NCT01901302|B3|Baseline|Total|Total of all reporting groups
693611|NCT01901302|B2|Baseline|Placebo|Placebo administered orally BID for a 12-week treatment period
693612|NCT01901302|B1|Baseline|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693613|NCT01901302|P2|Participant Flow|Placebo|Placebo administered orally BID for a 12-week treatment period
693614|NCT01901302|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945 administered orally twice daily (BID) for a 12-week treatment period
693615|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693616|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693617|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693618|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693619|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693620|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693621|NCT01901302|O2|Outcome|Placebo|Placebo administered orally BID for a 12-week treatment period
693622|NCT01901302|O1|Outcome|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693623|NCT01901302|E2|Reported Event|Placebo|Placebo administered orally BID for a 12-week treatment period
693624|NCT01901302|E1|Reported Event|CB-5945|0.25 mg CB-5945 administered orally BID for a 12-week treatment period
693625|NCT01901250|B3|Baseline|Total|Total of all reporting groups
693626|NCT01901250|B2|Baseline|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693627|NCT01901250|B1|Baseline|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693628|NCT01901250|P2|Participant Flow|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693629|NCT01901250|P1|Participant Flow|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693630|NCT01901250|O2|Outcome|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693631|NCT01901250|O1|Outcome|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693632|NCT01901250|E2|Reported Event|Fiber GB|"Sugar free fiber gummy bears 20g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Sugar free fiber gummy bears: The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693633|NCT01901250|E1|Reported Event|Xylitol GB|"Xylitol gummy bears 7.8g/day throughout the 9 month kindergarten year, oral health education, fluoride varnish, and dental sealant~Xylitol gummy bears: The children receive xylitol gummy bears 3 times/day within the supervised school environment.~Oral health education: Oral health education, toothbrush, and fluoride toothpaste~Fluoride varnish: The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.~Dental sealant: The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted."
693634|NCT01901211|B3|Baseline|Total|Total of all reporting groups
693635|NCT01901211|B2|Baseline|Comparison Arm|"In this arm of the study, participants will complete comparison activities during the first ten-week then after 6-week washout, will participate in the exergaming intervention during the second ten-week period.~Participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
693636|NCT01901211|B1|Baseline|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week then after 6-week washout, will participate in the comparison activities during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
693637|NCT01901211|P2|Participant Flow|Comparison Arm|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.~participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
693638|NCT01901211|P1|Participant Flow|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
693639|NCT01901211|O2|Outcome|Comparison Arm|In this arm of the study, participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week.
693663|NCT01900249|B2|Baseline|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
693664|NCT01900249|B1|Baseline|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
694358|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
693640|NCT01901211|O1|Outcome|Exergaming|"In this arm, the participants will participate in the exergaming intervention.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
693641|NCT01901211|E2|Reported Event|Comparison Arm|"In this arm of the study, participants will participate in comparison activities during the first ten-week period then after 6-week washout, will participate in the Exergaming activities during the second ten-week period.~participants will engage in their typical physical activity routines for the ten week duration. Participants will receive a call from the RA each week. The RA will ask the child to report on all the physical and social activities that they engaged in for that week."
693642|NCT01901211|E1|Reported Event|Exergaming|"In this arm, the participants will participate in the exergaming intervention during the first ten-week period then after 6-week washout, will participate in the comparison during the second ten-week period.~Exergaming Intervention: The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues."
693643|NCT01901185|B1|Baseline|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
693644|NCT01901185|P1|Participant Flow|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
693645|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
693646|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
693647|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
693648|NCT01901185|O1|Outcome|Etanercept / Autoinjector A|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week from Weeks 1 to 5 (total of 6 injections).
693649|NCT01901185|E1|Reported Event|Autoinjector A/Etanercept|Participants self-injected 50 mg etanercept subcutaneously using autoinjector A at the study center on Day 1 and then once a week at Weeks 1 - 5 (total of 6 injections).
693650|NCT01900314|B3|Baseline|Total|Total of all reporting groups
693651|NCT01900314|B2|Baseline|Sham rTMS|20 sham sessions
693652|NCT01900314|B1|Baseline|Active rTMS|20 active sessions
693653|NCT01900314|P2|Participant Flow|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second functional magnetic resonance imaging scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
693654|NCT01900314|P1|Participant Flow|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second functional magnetic resonance imaging scan will be completed then 5 additional tapering treatments of rTMS over a 2 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
693655|NCT01900314|O2|Outcome|Sham rTMS|20 sham sessions
693656|NCT01900314|O1|Outcome|Active rTMS|20 active sessions
693657|NCT01900314|O2|Outcome|Sham rTMS|20 sham sessions
693658|NCT01900314|O1|Outcome|Active rTMS|20 active sessions of rTMS
693659|NCT01900314|E2|Reported Event|Sham rTMS|"20 sham sessions, within a 4 week period, where subjects receive inactive treatments (0 Hz) of repetitive Transcranial Magnetic Stimulation (rTMS). After 20 sessions and completion of a second fMRI scan, patients in this group will then be unblinded and transitioned to the active arm and will receive a full course (25 sessions) of active rTMS over a 6 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
693660|NCT01900314|E1|Reported Event|Active rTMS|"20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the FDA-approved device label (10 Hz) to a targeted area of the brain. After these sessions, a second fMRI will be completed then 5 additional tapering treatments of rTMS over a 2 week period.~repetitive Transcranial Magnetic Stimulation (rTMS): 20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm."
693661|NCT01900249|B4|Baseline|Total|Total of all reporting groups
693662|NCT01900249|B3|Baseline|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
730101|NCT01694108|O2|Outcome|Control Children|No intervention
693665|NCT01900249|P3|Participant Flow|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
693666|NCT01900249|P2|Participant Flow|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
693667|NCT01900249|P1|Participant Flow|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
693668|NCT01900249|O3|Outcome|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
693669|NCT01900249|O2|Outcome|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
693670|NCT01900249|O1|Outcome|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
693671|NCT01900249|E3|Reported Event|Placebo|"Placebo Ophthalmic Solution, 1 drop per eye twice a day for 12 weeks.~Placebo: Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks."
693672|NCT01900249|E2|Reported Event|R348 Ophthalmic Solution, 0.5%|"R348 Ophthalmic Solution, 0.5%~R348 Ophthalmic Solution, 0.5%: R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks."
693673|NCT01900249|E1|Reported Event|R348 Ophthalmic Solution, 0.2%|"R348 Ophthalmic Solution, 0.2%~R348 Ophthalmic Solution, 0.2%: R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks."
693674|NCT01900067|B3|Baseline|Total|Total of all reporting groups
693675|NCT01900067|B2|Baseline|Control|no active warming, standard of care
693676|NCT01900067|B1|Baseline|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
693677|NCT01900067|P2|Participant Flow|Control|no active warming, standard of care
693678|NCT01900067|P1|Participant Flow|Active Warming|"BARRIER® EasyWarm Active Self-Warming Blanket~BARRIER® EasyWarm Active Self-Warming Blanket"
693679|NCT01900067|O2|Outcome|Control|No active warming, standard of care
693680|NCT01900067|O1|Outcome|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
693681|NCT01900067|E2|Reported Event|Control|No active warming, standard of care
693682|NCT01900067|E1|Reported Event|Active Warming|BARRIER® EasyWarm Active Self-Warming Blanket
693683|NCT01900054|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 12 weeks
693684|NCT01900054|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 12 weeks
693685|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
693686|NCT01900054|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 12 weeks
693687|NCT01900054|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 12 weeks
693688|NCT01899911|B1|Baseline|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
693689|NCT01899911|P1|Participant Flow|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
693690|NCT01899911|O1|Outcome|Vital Signs Patch (VSP)|Infrared and Red absorbance measurement on chest
693691|NCT01899911|E1|Reported Event|Vital Signs Patch (VSP)|"Infrared and Red absorbance measurement on chest~VSP: Infrared and red absorbance measurement"
693692|NCT01899768|B1|Baseline|GSK2339345 1000 µg/Placebo|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693693|NCT01899768|P1|Participant Flow|GSK2339345 1000 µg|Participants received two doses of either GSK2339345 1000 µg or matching placebo as a solution administered via an ADI with a four hour dosing interval at 3 visits (one treatment per visit) in Part A and a single dose at 2 visits (one treatment per visit) in Part B and C. Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo or GSK2339345 at each visit period in Part B and C, participants received an oral inhalation of 10 microliter (µL) of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit of Part C. The strength of capsaicin solution ranged from 0.49 to 1000 micromolar (µM) and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693694|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693772|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693839|NCT01898884|P4|Participant Flow|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
694359|NCT01896050|O2|Outcome|Tamoxifen|Subjects who started treatment with tamoxifen
693695|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693696|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693697|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693698|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693699|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693700|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693701|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693702|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693773|NCT01899742|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693703|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693704|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693705|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693706|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693707|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693708|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693709|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693710|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693807|NCT01899144|P1|Participant Flow|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
693711|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693712|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693713|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693714|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693715|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693716|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693717|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693718|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693808|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
693719|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693720|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693721|NCT01899768|O1|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693722|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693723|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693724|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693725|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693726|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693809|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
693727|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693728|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693729|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693730|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693731|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693732|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693733|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693734|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693810|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
693735|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693736|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693737|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693738|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693739|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693740|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693741|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693742|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693834|NCT01898884|P9|Participant Flow|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
700408|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
693743|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693744|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693745|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693746|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693747|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693748|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693749|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693750|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693835|NCT01898884|P8|Participant Flow|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
700409|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
693751|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693752|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693753|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693754|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693755|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693756|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693757|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693758|NCT01899768|O2|Outcome|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693836|NCT01898884|P7|Participant Flow|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
700410|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
693759|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693760|NCT01899768|O2|Outcome|GSK2339345 1000 Microgram (mcg)|Participants received two doses of GSK2339345 1000 mcg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693761|NCT01899768|O1|Outcome|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693762|NCT01899768|E2|Reported Event|GSK2339345 1000 µg|Participants received two doses of GSK2339345 1000 µg via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693763|NCT01899768|E1|Reported Event|Placebo|Participants received two doses of placebo as a solution administered via an ADI with a four hour dosing interval, either at one or two visits in Part A (Visits 1, 2 and 3) and a single dose at one of the 2 visits in Parts B (Visits 4 and 5) and Part C (Visits 6 and 7). Dose 1 was administered on each treatment day at the same time each morning throughout all of Parts A, B and C. The follow-up of each participant occurred 3-14 days after the last dose. There was a washout of 48 hours to 7 days between visits. Additionally, 5 minutes after the administration of placebo at each visit in Part B and C, participants received an oral inhalation of 10 µL of a capsaicin solution at each visit in Part B and 10 µL of a citric acid solution at each visit in Part C. The strength of capsaicin solution ranged from 0.49 to 1000 µM and the citric acid solution strength ranged from 0.03 to 4.0 molar.
693764|NCT01899742|B3|Baseline|Total|Total of all reporting groups
693765|NCT01899742|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693766|NCT01899742|B1|Baseline|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693767|NCT01899742|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693768|NCT01899742|P1|Participant Flow|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 micrograms (µg) once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693769|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693770|NCT01899742|O1|Outcome|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693771|NCT01899742|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one dose of tiotropium bromide 18 µg once daily via a HANDIHALER and placebo once daily via an ELLIPTA dry powder inhaler each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693837|NCT01898884|P6|Participant Flow|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693774|NCT01899742|E1|Reported Event|Umeclidinium/Vilanterol 62.5/25 µg|Participants self-administered one dose of umeclidinium/vilanterol inhalation powder 62.5/25 µg once daily via an ELLIPTA dry powder inhaler and placebo once daily via a HANDIHALER each morning for 12 weeks. Each inhaler containing placebo was identical in appearance to its corresponding inhaler containing active study medication.
693775|NCT01899677|B3|Baseline|Total|Total of all reporting groups
693776|NCT01899677|B2|Baseline|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693777|NCT01899677|B1|Baseline|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693778|NCT01899677|P2|Participant Flow|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693779|NCT01899677|P1|Participant Flow|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693780|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693781|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693782|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693783|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693784|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693785|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693786|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693787|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693788|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693789|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693790|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693791|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693792|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693793|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693794|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693795|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693796|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693797|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693798|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693799|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693800|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693801|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693802|NCT01899677|O2|Outcome|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693803|NCT01899677|O1|Outcome|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693804|NCT01899677|E2|Reported Event|Distilled Water|"2 x 0.5 cc distilled water will be given during 30 days~distilled water: 0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days"
693805|NCT01899677|E1|Reported Event|Symbiotic|"symbiotic preparation 1/2 sachet twice daily during 30 days~symbiotic: Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days"
693806|NCT01899144|B1|Baseline|All Participants|Participants were assigned to 1 of 10 possible treatment sequences for five treatments, separated by 2-7 days. Treatments were single inhalations of Albuterol MDPI 90 mcg, Albuterol MDPI 180 mcg, ProAir HFA MDI 90 mcg, ProAir HFA MDI 180 mcg, and placebo.
693811|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
693812|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
693813|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
693814|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
693815|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
693816|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
693817|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
693818|NCT01899144|O5|Outcome|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
693819|NCT01899144|O4|Outcome|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
693820|NCT01899144|O3|Outcome|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
693821|NCT01899144|O2|Outcome|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
693822|NCT01899144|O1|Outcome|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
693823|NCT01899144|E5|Reported Event|Placebo|At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind. In this arm, all devices contain placebo.
693824|NCT01899144|E4|Reported Event|ProAir HFA 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the MDIs contain ProAir HFA 90 mcg for a total dose of 180 mcg; the DPIs contained placebo."
693825|NCT01899144|E3|Reported Event|ProAir HFA 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the MDIs contains ProAir HFA 90 mcg; the other three devices contained placebo."
693826|NCT01899144|E2|Reported Event|Albuterol Spiromax 180 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, both of the DPIs contain Albuterol Spiromax 90 mcg for a total dose of 180 mcg; the MDIs contained placebo."
693827|NCT01899144|E1|Reported Event|Albuterol Spiromax 90 mcg|"At each treatment visit, participants receive 1 actuation from each of 4 pre-arranged device combinations comprising 2 dry powder inhalers (DPIs) and 2 metered-dose inhalers (MDIs) in order to maintain the study blind.~In this arm, one of the DPIs contains Albuterol Spiromax 90 mcg; the other three devices contained placebo."
693828|NCT01898884|B6|Baseline|Total|Total of all reporting groups
693829|NCT01898884|B5|Baseline|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693830|NCT01898884|B4|Baseline|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693831|NCT01898884|B3|Baseline|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693832|NCT01898884|B2|Baseline|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693833|NCT01898884|B1|Baseline|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693838|NCT01898884|P5|Participant Flow|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693840|NCT01898884|P3|Participant Flow|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693841|NCT01898884|P2|Participant Flow|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693842|NCT01898884|P1|Participant Flow|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693843|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693844|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693845|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693846|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693847|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693848|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693849|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693850|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693851|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693852|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693853|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693854|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693855|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693856|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693857|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693858|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693859|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693860|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693861|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693862|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693863|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693864|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693865|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693866|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693867|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693868|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693869|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693870|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693871|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693872|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693873|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693874|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693875|NCT01898884|O3|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693876|NCT01898884|O2|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693877|NCT01898884|O1|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693878|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693879|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693880|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693881|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693882|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693883|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693884|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693885|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693886|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693887|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693888|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693889|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693890|NCT01898884|O4|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693891|NCT01898884|O3|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693892|NCT01898884|O2|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693893|NCT01898884|O1|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693894|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693895|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693896|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693897|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693898|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693899|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693900|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693901|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693902|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693903|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693904|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
730102|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
693905|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693906|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693907|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693908|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693909|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693910|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693911|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693912|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693913|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693914|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693915|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693916|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693917|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693918|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693919|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693920|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693921|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693922|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693923|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693924|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693925|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693926|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693927|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693928|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693929|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693930|NCT01898884|O2|Outcome|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693931|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693932|NCT01898884|O4|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693933|NCT01898884|O3|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693934|NCT01898884|O2|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693935|NCT01898884|O1|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693936|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693937|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693938|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693939|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693940|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693941|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693942|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693943|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693944|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693945|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693946|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693947|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693948|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693949|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693950|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693951|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693952|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693953|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693954|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693955|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693956|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693957|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693958|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693959|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693960|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693961|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693962|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693963|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693964|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693965|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693966|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693967|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693968|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693969|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693970|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693971|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693972|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693973|NCT01898884|O9|Outcome|Multiple Dose VP 20629 900 mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693974|NCT01898884|O8|Outcome|Multiple Dose VP 20629 600 mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693975|NCT01898884|O7|Outcome|Multiple Dose VP 20629 300 mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693976|NCT01898884|O6|Outcome|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693977|NCT01898884|O5|Outcome|Single Dose VP 20629 1200 mg|Participants received single dose of VP 20629 capsules of 1200 mg orally under fasting condition on Day 1.
693978|NCT01898884|O4|Outcome|Single Dose VP 20629 900 mg|Participants received single dose of VP 20629 capsules of 900 mg orally under fasting condition on Day 1.
693979|NCT01898884|O3|Outcome|Single Dose VP 20629 450 mg|Participants received single dose of VP 20629 capsules of 450 mg orally under fasting condition on Day 1.
693980|NCT01898884|O2|Outcome|Single Dose VP 20629 150 mg|Participants received single dose of VP 20629 capsules of 150 milligram (mg) orally under fasting condition on Day 1.
693981|NCT01898884|O1|Outcome|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting condition on Day 1.
693982|NCT01898884|E9|Reported Event|Multiple Dose VP 20629 900mg|Participants received VP 20629 capsules 900 mg total daily dose in 3 divided doses (300 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
700411|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
693983|NCT01898884|E8|Reported Event|Multiple Dose VP 20629 600mg|Participants received VP 20629 capsules 600 mg total daily dose in 3 divided doses (200 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693984|NCT01898884|E7|Reported Event|Multiple Dose VP 20629 300mg|Participants received VP 20629 capsules 300 mg total daily dose in 3 divided doses (100 mg every 8 hours) orally daily from Day 1 to Day 8 morning under fasting conditions.
693985|NCT01898884|E6|Reported Event|Multiple Dose Placebo|Participants received placebo matching to multiple doses of VP 20629 capsules orally daily from Day 1 to Day 8 morning under fasting conditions.
693986|NCT01898884|E5|Reported Event|Single Dose VP 20629 1200mg|Participants received single dose VP 20629 capsules of 1200 mg orally under fasting conditions on Day 1.
693987|NCT01898884|E4|Reported Event|Single Dose VP 20629 900mg|Participants received single dose VP 20629 capsules of 900 mg orally under fasting conditions on Day 1.
693988|NCT01898884|E3|Reported Event|Single Dose VP 20629 450mg|Participants received single dose VP 20629 capsules of 450 mg orally under fasting conditions on Day 1.
693989|NCT01898884|E2|Reported Event|Single Dose VP 20629 150mg|Participants received single dose VP 20629 capsules of 150 milligram (mg) orally under fasting conditions on Day 1.
693990|NCT01898884|E1|Reported Event|Single Dose Placebo|Participants received placebo matching to single dose of VP 20629 capsules orally under fasting conditions on Day 1.
693991|NCT01898598|B3|Baseline|Total|Total of all reporting groups
693992|NCT01898598|B2|Baseline|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
693993|NCT01898598|B1|Baseline|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
693994|NCT01898598|P2|Participant Flow|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
693995|NCT01898598|P1|Participant Flow|Vismodegib|Participants received vismodegib 150 milligrams (mg) capsule orally once daily for 12 weeks.
693996|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
693997|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
693998|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
693999|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
694000|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
694001|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
694002|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
694003|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
694004|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
694005|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
694006|NCT01898598|O2|Outcome|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
694007|NCT01898598|O1|Outcome|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
694008|NCT01898598|E2|Reported Event|Placebo|Participants received matching placebo to vismodegib capsule orally once daily for 12 weeks.
694009|NCT01898598|E1|Reported Event|Vismodegib|Participants received vismodegib 150 mg capsule orally once daily for 12 weeks.
694010|NCT01898442|B4|Baseline|Total|Total of all reporting groups
694011|NCT01898442|B3|Baseline|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694012|NCT01898442|B2|Baseline|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694013|NCT01898442|B1|Baseline|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694014|NCT01898442|P3|Participant Flow|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694015|NCT01898442|P2|Participant Flow|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694016|NCT01898442|P1|Participant Flow|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694017|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694018|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694019|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694020|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694021|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694022|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694023|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694024|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694025|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694026|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694027|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694028|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694029|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694030|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694031|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694032|NCT01898442|O3|Outcome|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694033|NCT01898442|O2|Outcome|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694034|NCT01898442|O1|Outcome|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694035|NCT01898442|E3|Reported Event|Ticagrelor 360mg|"High ticagrelor 360mg loading dose~Ticagrelor 360mg: Randomization to a high ticagrelor loading dose regimen"
694036|NCT01898442|E2|Reported Event|Ticagrelor 270mg|"High ticagrelor 270mg loading dose~Ticagrelor 270mg: Randomization to a high ticagrelor loading dose regimen"
694037|NCT01898442|E1|Reported Event|Ticagrelor 180mg|"Standard ticagrelor 180mg loading dose~Ticagrelor 180mg: Randomization to standard ticagrelor loading dose"
694038|NCT01898403|B1|Baseline|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
694039|NCT01898403|P1|Participant Flow|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
694040|NCT01898403|O3|Outcome|Sentinel Lymph Node (SLN) Detection by TSC Lymphoscintigraphy|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
694041|NCT01898403|O2|Outcome|Sentinel Lymph Node (SLN) Detection by Indocyanine Green|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
694042|NCT01898403|O1|Outcome|Sentinel Lymph Node (SLN) Detection by Isosulfan Blue|All patients received peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.
694043|NCT01898403|E1|Reported Event|Sentinel Lymph Node (SLN) Detection|"All patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution for detection of melanoma in lymph nodes. In addition, lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC) will be conducted for all participants with the same objective.~Indocyanine green solution: Administered peri-tumoral and intradermally~Isosulfan blue (ISB): Administered peri-tumoral and intradermally~Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)"
694044|NCT01898286|B1|Baseline|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
694045|NCT01898286|P1|Participant Flow|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
694046|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
694047|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
694048|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
694049|NCT01898286|O1|Outcome|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
694050|NCT01898286|E1|Reported Event|Patients Treated With DiaPep (Originally Enrolled in Study1001|All patients enrolled in the 1010 study (NCT01898286), whether previously treated with DiaPep277 or placebo in the 1001 study (NCT01103284).
694051|NCT01898208|B4|Baseline|Total|Total of all reporting groups
694052|NCT01898208|B3|Baseline|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694053|NCT01898208|B2|Baseline|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694054|NCT01898208|B1|Baseline|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694055|NCT01898208|P3|Participant Flow|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
730103|NCT01694108|O2|Outcome|Control Children|No intervention
694056|NCT01898208|P2|Participant Flow|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694057|NCT01898208|P1|Participant Flow|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694058|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694059|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694060|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694061|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694062|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694063|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694064|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694065|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694066|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694067|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694068|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694069|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694070|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694071|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694072|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694073|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694074|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694075|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694076|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694077|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694078|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694079|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694080|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694081|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694131|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694082|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694083|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694084|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694085|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694086|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694087|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694088|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694089|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694090|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694091|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694092|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694093|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694094|NCT01898208|O3|Outcome|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694095|NCT01898208|O2|Outcome|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694096|NCT01898208|O1|Outcome|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694097|NCT01898208|E3|Reported Event|FilmArray Plus Antimicrobial Stewardship|Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
694098|NCT01898208|E2|Reported Event|FilmArray Test|Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
694099|NCT01898208|E1|Reported Event|Control|Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
694100|NCT01898091|B3|Baseline|Total|Total of all reporting groups
694101|NCT01898091|B2|Baseline|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
694102|NCT01898091|B1|Baseline|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
694103|NCT01898091|P2|Participant Flow|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
694104|NCT01898091|P1|Participant Flow|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
694105|NCT01898091|O2|Outcome|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
694106|NCT01898091|O1|Outcome|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy."
694360|NCT01896050|O1|Outcome|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
694107|NCT01898091|E2|Reported Event|Placebo Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Placebo Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base], three times per day, for approximately 7 weeks during radiation therapy."
694108|NCT01898091|E1|Reported Event|Neem Mouthrinse|"Participants will rinse for 30 seconds with the measured 10ml dose of the assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.~Neem Mouthrinse: 10ml dose of assigned study mouthrinse [mouthrinse base plus 1% solution by weight of neem supercritical extract], three times per day, for approximately 7 weeks during radiation therapy."
694109|NCT01897792|B3|Baseline|Total|Total of all reporting groups
694110|NCT01897792|B2|Baseline|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
694111|NCT01897792|B1|Baseline|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
694112|NCT01897792|P2|Participant Flow|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
694113|NCT01897792|P1|Participant Flow|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
694114|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694115|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694116|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694117|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694118|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694119|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694120|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694121|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694122|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694123|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694124|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill Participants - Protocol Violations|# of protocol deviations
694125|NCT01897792|O1|Outcome|Vitamin C and E Participants -|# of protocol deviations
694126|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694127|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694128|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694129|NCT01897792|O1|Outcome|Vitamins C and E|Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694130|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.
694132|NCT01897792|O2|Outcome|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
694133|NCT01897792|O1|Outcome|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
694134|NCT01897792|E2|Reported Event|0.9% Saline and Sugar Pill|"100 ml of 0.9% saline (for i.v. Vitamin C) and a p.o. placebo (sugar pill for the p.o. Vitamin E) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Saline (for Vitamin C): 0.9% saline administered to mimic Vitamin C~Placebo (for Vitamin E): Sugar pill administered to mimic Vitamin E"
694135|NCT01897792|E1|Reported Event|Vitamins C and E|"Vitamin C (1,000 mg i.v.) and Vitamin E (1,000 IU p.o. via the naso-gastric tube) administered every 8 hours starting within one hour after admission to the Emergency department for up to 5 days or until discharge from the ICU, whichever comes first.~Vitamin C~Vitamin E"
694136|NCT01897727|B3|Baseline|Total|Total of all reporting groups
694137|NCT01897727|B2|Baseline|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
694138|NCT01897727|B1|Baseline|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
694139|NCT01897727|P2|Participant Flow|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
694140|NCT01897727|P1|Participant Flow|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
694141|NCT01897727|O2|Outcome|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
694142|NCT01897727|O1|Outcome|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
694143|NCT01897727|E2|Reported Event|Standard of Care BP Treatment|Antihypertensive medication added and/or uptitrated to keep BP < 140/90 mm Hg throughout the study.
694144|NCT01897727|E1|Reported Event|Spironolactone|Spironolactone 25 mg administered following baseline measurements and uptitrated to 50 mg if BP > 140/90 mm Hg throughout the 3 month study.
694145|NCT01897402|B3|Baseline|Total|Total of all reporting groups
694146|NCT01897402|B2|Baseline|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
694147|NCT01897402|B1|Baseline|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
694148|NCT01897402|P2|Participant Flow|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
694149|NCT01897402|P1|Participant Flow|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
694150|NCT01897402|O2|Outcome|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
694151|NCT01897402|O1|Outcome|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
694152|NCT01897402|O4|Outcome|US Licensed Vaccine - Female|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
694153|NCT01897402|O3|Outcome|US Licensed Vaccine - Male|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
694154|NCT01897402|O2|Outcome|Test Vaccine - Female|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
694155|NCT01897402|O1|Outcome|Test Vaccine - Male|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
694156|NCT01897402|O2|Outcome|US Licensed Vaccine|"Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine~US Licensed Vaccine: Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid."
694157|NCT01897402|O1|Outcome|Test Vaccine|"NmVac4-A/C/Y/W-135-DT™ conjugate vaccine~Test Vaccine: NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid."
694158|NCT01897402|E2|Reported Event|US Licensed Vaccine|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
694159|NCT01897402|E1|Reported Event|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate vaccine
694160|NCT01897285|B1|Baseline|All Participants: AQUACEL® Foam Adhesive Dressings|"Original adhesive + test adhesive~AQUACEL® foam adhesive dressings"
694161|NCT01897285|P1|Participant Flow|All Study Participants|"Original adhesive and Test adhesive on right and left upper arm and right and left lower back.~AQUACEL® foam adhesive dressing Original Adhesive: Arm, Test Adhesive: Arm, Original Adhesive: Back, Test Adhesive: Back"
694162|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
694163|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
694164|NCT01897285|O2|Outcome|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
694165|NCT01897285|O1|Outcome|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
694166|NCT01897285|E2|Reported Event|AQUACEL® Foam Adhesive Dressing - Test Adhesive|"Test adhesive~AQUACEL® foam adhesive dressing"
694167|NCT01897285|E1|Reported Event|AQUACEL® Foam Adhesive Dressing - Original Adhesive|"Original adhesive~AQUACEL® foam adhesive dressing"
694168|NCT01897233|B1|Baseline|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
694169|NCT01897233|P1|Participant Flow|Lumacaftor/Ivacaftor (LUM/IVA)|"Part A Cohort 1: Participants aged 6 through 8 years received LUM 200 milligram (mg) in fixed-dose combination with IVA 250 mg orally every 12 hours (q12h) for 14 days.~Part A Cohort 2: Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.~Part B: Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks."
694170|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694171|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694172|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694173|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694174|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694175|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694176|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694177|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694178|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks
694179|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694180|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694181|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
694182|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
694183|NCT01897233|O1|Outcome|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694184|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
694185|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
694186|NCT01897233|O1|Outcome|Part A Overall Arm: LUM/IVA|All participants aged 6 through 11 years who received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
694187|NCT01897233|E3|Reported Event|Part B: LUM/IVA|Participants aged 6 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
694188|NCT01897233|E2|Reported Event|Part A Cohort 2: LUM/IVA|Participants aged 9 through 11 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
694189|NCT01897233|E1|Reported Event|Part A Cohort 1: LUM/IVA|Participants aged 6 through 8 years received LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.
694190|NCT01897025|B3|Baseline|Total|Total of all reporting groups
694191|NCT01897025|B2|Baseline|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
694192|NCT01897025|B1|Baseline|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
694193|NCT01897025|P2|Participant Flow|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
694194|NCT01897025|P1|Participant Flow|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
694219|NCT01896726|E2|Reported Event|Baricitinib|"10 mg baricitinib tablet administered orally, QD, on Days 23 through 28.~Adverse events are reported from postdose on Day 23 through predose on Day 29."
694361|NCT01896050|E2|Reported Event|Tamoxifen|Subjects who started treatment with tamoxifen
694195|NCT01897025|O2|Outcome|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
694196|NCT01897025|O1|Outcome|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
694197|NCT01897025|E2|Reported Event|Sham-tDCS With MI-BCI|"10 sessions of sham tDCS with BCI motor training, each session of which will be conducted as follows:~The same electrode placement and stimulation parameters will be employed for sham tDCS as for real tDCS. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation. This method of sham stimulation has also been validated (Gandiga et al., 2006). Current intensity will be increased and decreased gradually to decrease perception.~MI-BCI training will be the same as the real-tDCS group and will similarly last for 40 minutes.~real-tDCS with MI-BCI: As in Arm Description"
694198|NCT01897025|E1|Reported Event|Real-tDCS With MI-BCI|"10 sessions of the following: 20 minutes of tDCS prior to each session of motor training with the MI-BCI system.~Direct current at an intensity of 1mA with anode placed over the M1 motor cortex of the affected hemisphere and the cathode placed over the unaffected M1.~After initial calibration, MI-BCI training will involve motor imagery of reaching tasks using the clock game interface of the MIT-Manus robotic system to perform multi-directional reaching movements. Upon detection of the intention to move towards the target on BCI, the robotic arm will complete the reaching movement towards the target. Each training session will last for 40 minutes excluding set-up time.~real-tDCS with MI-BCI: As in Arm Description"
694199|NCT01896986|B3|Baseline|Total|Total of all reporting groups
694200|NCT01896986|B2|Baseline|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
694201|NCT01896986|B1|Baseline|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy"
694202|NCT01896986|P2|Participant Flow|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy"
694203|NCT01896986|P1|Participant Flow|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy"
694204|NCT01896986|O2|Outcome|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy~No samples analysed."
694205|NCT01896986|O1|Outcome|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy~No samples analysed."
694206|NCT01896986|E2|Reported Event|IBD Patients|"Children/adolescent females 12-26 years diagnosed with IBD.~Subgroups:~3. receiving immunosuppressant therapy 4. not on immunosuppressant therapy~no adverse events"
694207|NCT01896986|E1|Reported Event|PRD Patrients|"Children/adolescent females 12-26 years with a PRD such as JIA (Juvenile Idiopathic Arthritis) or SLE (Systemic Lupus Erythematosus)~Subgroups:~receiving immunosuppressant therapy~not on immunosuppressant therapy~no adverse events"
694208|NCT01896726|B1|Baseline|Baricitinib + Microgynon|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Days 1 and 29. 10 mg baricitinib tablet administered orally, QD, on Days 23 through 30.
694209|NCT01896726|P1|Participant Flow|Baricitinib + Microgynon|Microgynon tablet [30 micrograms (µg) ethinyl estradiol and 150 µg levonorgestrel] administered orally, once daily (QD), on Days 1 and 29. 10 milligrams (mg) baricitinib tablet administered orally, QD, on Days 23 through 30.
694210|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
694211|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
694212|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
694213|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
694214|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
694215|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
694216|NCT01896726|O2|Outcome|Baricitinib + Microgynon|10 mg baricitinib tablet administered orally, QD, on Days 23 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.
694217|NCT01896726|O1|Outcome|Microgynon Alone|Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1
694218|NCT01896726|E3|Reported Event|Baricitinib + Microgynon|"10 mg baricitinib tablet administered orally, QD, on Days 29 through 30 with coadministration of Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 29.~Adverse events are reported from postdose on Day 29 up to Day 40."
694220|NCT01896726|E1|Reported Event|Microgynon Alone|"Microgynon tablet (30 µg ethinyl estradiol and 150 µg levonorgestrel) administered orally, QD, on Day 1.~Adverse events are reported from baseline through predose on Day 23."
694221|NCT01896687|B3|Baseline|Total|Total of all reporting groups
694222|NCT01896687|B2|Baseline|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
694223|NCT01896687|B1|Baseline|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
694224|NCT01896687|P2|Participant Flow|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
694225|NCT01896687|P1|Participant Flow|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
694226|NCT01896687|O2|Outcome|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
694227|NCT01896687|O1|Outcome|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
694228|NCT01896687|E2|Reported Event|Sham Scrambler Treatment|"Sham treatment applied to region above low back pain at nontherapeutic dose for 30 minutes x 10 days~Scrambler: Electrotherapy"
694229|NCT01896687|E1|Reported Event|Scrambler Therapy|"Scrambler therapy applied to region of low back pain for 30 minutes x 10 days~Scrambler: Electrotherapy"
694230|NCT01896557|B3|Baseline|Total|Total of all reporting groups
694231|NCT01896557|B2|Baseline|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
694232|NCT01896557|B1|Baseline|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
694233|NCT01896557|P2|Participant Flow|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
694234|NCT01896557|P1|Participant Flow|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
694235|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
694236|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
694237|NCT01896557|O2|Outcome|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
694238|NCT01896557|O1|Outcome|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
694239|NCT01896557|E2|Reported Event|Ranitidine|Ranitidine 150 mg BID oral route was added to clopidogrel.
694240|NCT01896557|E1|Reported Event|Omeprazole|"Omeprazole 20 mg (oral route) twice a day will be given to the subjects for one week. This intervention will be compared with ranitidin 150 mg (oral route) twice a day.~omeprazole: Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated."
694241|NCT01896544|B4|Baseline|Total|Total of all reporting groups
694242|NCT01896544|B3|Baseline|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694243|NCT01896544|B2|Baseline|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
694244|NCT01896544|B1|Baseline|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694245|NCT01896544|P3|Participant Flow|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694246|NCT01896544|P2|Participant Flow|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694247|NCT01896544|P1|Participant Flow|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
694248|NCT01896544|O3|Outcome|Cholecalciferol Dose 2|Oral suspension of cholecalciferol 400,000 IU
694249|NCT01896544|O2|Outcome|Cholecalciferol Dose 1|Oral suspension cholecalciferol 200,000 IU
694250|NCT01896544|O1|Outcome|Placebo|Oral suspension of placebo cholecalciferol
694251|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694252|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694253|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
694254|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694255|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694256|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
694257|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694258|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694259|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
694260|NCT01896544|O3|Outcome|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694261|NCT01896544|O2|Outcome|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694262|NCT01896544|O1|Outcome|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
694263|NCT01896544|E3|Reported Event|Cholecalciferol Dose II|"Oral suspension cholecalciferol 400,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694264|NCT01896544|E2|Reported Event|Cholecalciferol Dose I|"Oral suspension cholecalciferol 200,000 IU~Cholecalciferol: 7ml syringe of cholecalciferol suspension given through NG or OG tube"
694265|NCT01896544|E1|Reported Event|Placebo|"Oral suspension of placebo cholecalciferol~Placebo: 7ml syringe of placebo cholecalciferol suspension given through NG or OG tube"
694266|NCT01896297|B1|Baseline|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
694267|NCT01896297|P1|Participant Flow|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
694268|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
694269|NCT01896297|O1|Outcome|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
694270|NCT01896297|E1|Reported Event|Dabigatran Etexilate|Dabigatran etexilate 75mg capsule administered orally, twice daily (BID), for at least 7 days.
694271|NCT01896232|B3|Baseline|Total|Total of all reporting groups
694272|NCT01896232|B2|Baseline|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694273|NCT01896232|B1|Baseline|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694274|NCT01896232|P2|Participant Flow|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694275|NCT01896232|P1|Participant Flow|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694276|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694277|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694278|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694279|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694280|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694281|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694282|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694307|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
694308|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
694283|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694284|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694285|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694286|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694287|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694288|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694289|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694290|NCT01896232|O2|Outcome|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694291|NCT01896232|O1|Outcome|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694292|NCT01896232|E2|Reported Event|Etelcalcetide|Participants were randomized to receive etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW, and daily oral doses of placebo tablets for 26 weeks. The starting dose of etelcalcetide was 5 mg, and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining cCa ≥ 8.3 mg/dL.
694293|NCT01896232|E1|Reported Event|Cinacalcet|Participants were randomized to receive oral cinacalcet once daily and placebo intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks. The starting dose of cinacalcet was 30 mg daily and could have been titrated at weeks 5, 9, 13, and 17 to target predialysis serum PTH ≤ 300 pg/mL but no lower than 100 pg/mL while maintaining corrected calcium (cCa) ≥ 8.3 mg/dL.
694294|NCT01896206|B1|Baseline|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
694295|NCT01896206|P1|Participant Flow|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
694296|NCT01896206|O1|Outcome|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
694297|NCT01896206|E1|Reported Event|CNAP Monitor|"Subjects undergoing bariatric surgery and monitored using the CNAP monitor.~CNAP monitor: Patients undergoing bariatric surgery and being monitored using the CNAP monitor."
694298|NCT01896193|B5|Baseline|Total|Total of all reporting groups
694299|NCT01896193|B4|Baseline|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
694300|NCT01896193|B3|Baseline|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
694301|NCT01896193|B2|Baseline|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
694302|NCT01896193|B1|Baseline|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
694303|NCT01896193|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
694304|NCT01896193|P1|Participant Flow|SOF+RBV 16 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 16 weeks
694305|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
694306|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
694355|NCT01896050|O2|Outcome|Tamoxifen|Tamoxifen-treated patients
694309|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
694310|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
694311|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
694312|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
694313|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
694314|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
694315|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
694316|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
694317|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
694318|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
694319|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
694320|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
694321|NCT01896193|O4|Outcome|SOF+RBV 24 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 3)
694322|NCT01896193|O3|Outcome|SOF+RBV 16 Weeks, GT3|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 3)
694323|NCT01896193|O2|Outcome|SOF+RBV 24 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (genotype 1)
694324|NCT01896193|O1|Outcome|SOF+RBV 16 Weeks, GT1|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks (genotype 1)
694325|NCT01896193|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
694326|NCT01896193|E1|Reported Event|SOF+RBV 16 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 16 weeks
694327|NCT01896115|B1|Baseline|All Arms|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
694328|NCT01896115|P1|Participant Flow|All Arms|"Patients with a Vercise DBS system programmed to 30 microseconds pulse width~Patients with a Vercise DBS system programmed to 60 microseconds pulse width~Patients with a Vercise DBS system programmed to steer current ventrally~Patients with a Vercise DBS system programmed to steer current dorsally."
694329|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
694330|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
694331|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
694332|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
694333|NCT01896115|O4|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
694334|NCT01896115|O3|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
694335|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
694336|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
694337|NCT01896115|O2|Outcome|Dorsal Current Steering|Patients with a Vercise DBS system programmed to steer current dorsally
694338|NCT01896115|O1|Outcome|Ventral Current Steering|Patients with a Vercise DBS system programmed to steer current ventrally
694339|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
694340|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
694341|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
694342|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
694343|NCT01896115|O2|Outcome|Current Steering|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
694344|NCT01896115|O1|Outcome|Single Contact|All 24 patients analyzed for secondary endpoints received both single contact stimulation and current steering stimulation.
694345|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
694346|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
694347|NCT01896115|O2|Outcome|Conventional PW|Patients with a Vercise DBS system programmed to 60 microseconds pulse width
694348|NCT01896115|O1|Outcome|Short PW|Patients with a Vercise DBS system programmed to 30 microseconds pulse width
694349|NCT01896115|E1|Reported Event|All Arms|"Patients with a Vercise DBS system programmed to 4 different settings including:~Short pulse widths (30 microseconds)~Conventional pulse widths (60 microseconds)~Steering current ventrally~Steering current dorsally"
694350|NCT01896050|B3|Baseline|Total|Total of all reporting groups
694351|NCT01896050|B2|Baseline|Tamoxifen|Subjects who started treatment with tamoxifen
694352|NCT01896050|B1|Baseline|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
694353|NCT01896050|P2|Participant Flow|Tamoxifen|Subjects who started treatment with tamoxifen
694354|NCT01896050|P1|Participant Flow|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
694362|NCT01896050|E1|Reported Event|AI Therapy|Subjects who started treatment with any of the three aromatase inhibitor (AI) medications
694363|NCT01895946|B3|Baseline|Total|Total of all reporting groups
694364|NCT01895946|B2|Baseline|Part B|Part B of the study
694365|NCT01895946|B1|Baseline|Part A|Part A of the study
694366|NCT01895946|P2|Participant Flow|Part B|Part B of the study
694367|NCT01895946|P1|Participant Flow|Part A|Part A of the study
694368|NCT01895946|O2|Outcome|Part B|Part B of the study
694369|NCT01895946|O1|Outcome|Part A|Part A of the study
694370|NCT01895946|O2|Outcome|Part B|Part B of the study
694371|NCT01895946|O1|Outcome|Part A|Part A of the study
694372|NCT01895946|O2|Outcome|Part B|Part B of the study
694373|NCT01895946|O1|Outcome|Part A|Part A of the study
694374|NCT01895946|O2|Outcome|Part B|Part B of the study
694375|NCT01895946|O1|Outcome|Part A|Part A of the study
694376|NCT01895946|O2|Outcome|Part B|Part B of the study
694377|NCT01895946|O1|Outcome|Part A|Part A of the study
694378|NCT01895946|O2|Outcome|Part B|Part B of the study
694379|NCT01895946|O1|Outcome|Part A|Part A of the study
694380|NCT01895946|O2|Outcome|Part B|Part B of the study
694381|NCT01895946|O1|Outcome|Part A|Part A of the study
694382|NCT01895946|E2|Reported Event|Part B|Part B of the study
694383|NCT01895946|E1|Reported Event|Part A|Part A of the study
694384|NCT01895634|B1|Baseline|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694385|NCT01895634|P1|Participant Flow|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694386|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694387|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694388|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694389|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694390|NCT01895634|O1|Outcome|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694391|NCT01895634|E1|Reported Event|Treatment|"Intervention Device: Rev-01~Rev-01: Treatment arm patients have used Rev-01 at least once"
694392|NCT01895543|B1|Baseline|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694393|NCT01895543|P1|Participant Flow|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694394|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694395|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694396|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694397|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694398|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694399|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694400|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694401|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694402|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694403|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694404|NCT01895543|O1|Outcome|EBX10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694405|NCT01895543|E1|Reported Event|EBX 10|"Elobixibat 10 mg~Elobixibat 10 mg: 10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily."
694406|NCT01895335|B1|Baseline|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694407|NCT01895335|P1|Participant Flow|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling once daily (QD) orally for 48 weeks.
694408|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694409|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694410|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694411|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694412|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694413|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694414|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694415|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694416|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694417|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694418|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694419|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694420|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
700412|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
694421|NCT01895335|O1|Outcome|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694422|NCT01895335|E1|Reported Event|Teriflunomide|Teriflunomide 14 mg or 7 mg according to local labelling QD orally for 48 weeks.
694423|NCT01895322|B1|Baseline|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
694424|NCT01895322|P1|Participant Flow|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
694425|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
694426|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
694427|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an increase of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
694428|NCT01895322|O1|Outcome|OPC-41061|"In the dose-escalation period,the dose of OPC-41061 was to be sequentially increased every 2 days as indicated below until daily urine volume of the OPC-41061 administration at each dose showed an crease of at least 500 mL from the pre-observation period. Dose escalation was to be terminated at the dose at which daily urine volume increased by 500 mL or more. If an increase in daily urine volume of at least 500 mL was not observed at the dose of 60 mg/day, the subject was to be withdrawn from the trial.~- 7.5, 15, 30, 60 mg/day (up to a total of 8 days)~OPC-41061 was administered at a fixed dose (final dose administered in the dose-escalation period) once daily for 5 days on the repeated-administration period."
694429|NCT01895322|E1|Reported Event|OPC-41061|OPC-41061
694430|NCT01895309|B3|Baseline|Total|Total of all reporting groups
694431|NCT01895309|B2|Baseline|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
694432|NCT01895309|B1|Baseline|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
694433|NCT01895309|P2|Participant Flow|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
694434|NCT01895309|P1|Participant Flow|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
694435|NCT01895309|O4|Outcome|Enbrel (Etanercept) at Week 52|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
694436|NCT01895309|O3|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 52|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
694437|NCT01895309|O2|Outcome|Enbrel (Etanercept) at Week 24|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
694438|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept) at Week 24|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
694439|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
694440|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
694441|NCT01895309|O2|Outcome|Enbrel (Etanercept)|Enbrel 50 mg/week via subcutaneous injection
694442|NCT01895309|O1|Outcome|SB4 (Proposed Biosimilar to Etanercept)|SB4 50 mg/week via subcutaneous injection
694443|NCT01895309|E2|Reported Event|Enbrel (Etanercept)|"Enbrel 50 mg/week via subcutaneous injection~Enbrel (etanercept)"
694444|NCT01895309|E1|Reported Event|SB4 (Proposed Biosimilar to Etanercept)|"SB4 50 mg/week via subcutaneous injection~SB4 (proposed biosimilar to etanercept)"
694445|NCT01895270|B3|Baseline|Total|Total of all reporting groups
694446|NCT01895270|B2|Baseline|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
694478|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
694858|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694447|NCT01895270|B1|Baseline|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
694448|NCT01895270|P2|Participant Flow|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
694449|NCT01895270|P1|Participant Flow|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
694450|NCT01895270|O2|Outcome|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
694451|NCT01895270|O1|Outcome|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
694452|NCT01895270|E2|Reported Event|Placebo|"Placebo will consist of microcrystalline cellulose. Two placebo capsules will be administered per day starting week 1 day 3 through the end of the isradipine taper.~Placebo: Placebo will consist of microcrystalline cellulose."
694453|NCT01895270|E1|Reported Event|Isradipine|"Isradipine controlled-release formulation, 10 mg/day maintenance dose, will be administered according to the following dose procedures: Isradipine ingestion will occur under supervision 6 days per week, and a take-home dose will be given on Saturday for participants to take on Sunday. The initial dose of isradipine or placebo will be given on Day 3 of Week 1. The initial dose of isradipine will be 5 mg/day; the dose will increase to 10 mg/day on Day 3 of Week 3 and will continue through Day 2 of Week 7. On Day 3 of Week 7, isradipine will be decreased to 5 mg/day for 7 days. On Days 3–5 of Week 8, all participants will receive placebo. If ISR side effects are too severe at the 10-mg dose, isradipine will be decreased to 5 mg/day. If ISR side effects are too severe at 5 mg/day, isradipine will be discontinued and the participant will be discharged from the study and referred to local treatment agencies.~Isradipine: Isradipine extended release formulation"
694454|NCT01895101|B4|Baseline|Total|Total of all reporting groups
694455|NCT01895101|B3|Baseline|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
694456|NCT01895101|B2|Baseline|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
694457|NCT01895101|B1|Baseline|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
694458|NCT01895101|P3|Participant Flow|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
694459|NCT01895101|P2|Participant Flow|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
694596|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694460|NCT01895101|P1|Participant Flow|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
694461|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
694462|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
694463|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
694464|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
694465|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
694466|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
694467|NCT01895101|O3|Outcome|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
694468|NCT01895101|O2|Outcome|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
694469|NCT01895101|O1|Outcome|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
694470|NCT01895101|E3|Reported Event|2 gr Tranexamic Acid Diluted in 200 ml Normothermic Saline|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm receives also pericardial lavage with 2 gr TA diluted in 200 ml normothermic saline solution (NaCl 0.9%).~2 gr tranexamic acid: This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%)."
694471|NCT01895101|E2|Reported Event|No Pericardial Lavage|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~In this arm the subjects receives as in standard care no pericardial lavage."
694472|NCT01895101|E1|Reported Event|Pericardial Lavage With 200 ml Normothermic Saline Solution|"According to the anaesthetic protocol of the Amphia Hospital (Breda, the Netherlands), all patients scheduled for cardiac surgery receive intravenously 2 gr TA before sternal incision and 2 gr TA after cardiopulmonary bypass.~This arm also receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid.~Saline: This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid"
694473|NCT01895062|B3|Baseline|Total|Total of all reporting groups
694474|NCT01895062|B2|Baseline|no Intervention|Routine care is administered without the application of cNEP.
694475|NCT01895062|B1|Baseline|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
694476|NCT01895062|P2|Participant Flow|no Intervention|Routine care is administered without the application of cNEP.
694477|NCT01895062|P1|Participant Flow|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
694479|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
694480|NCT01895062|O2|Outcome|no Intervention|Routine care is administered without the application of cNEP.
694481|NCT01895062|O1|Outcome|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
694482|NCT01895062|E2|Reported Event|no Intervention|Routine care is administered without the application of cNEP.
694483|NCT01895062|E1|Reported Event|Active cNEP @ -45cmw|"cNEP @ -45 cmw is applied to the anterior surface of the neck with a soft collar attached to a vacuum source.~Airway Management System (AMS): The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
694484|NCT01894984|B3|Baseline|Total|Total of all reporting groups
694485|NCT01894984|B2|Baseline|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694486|NCT01894984|B1|Baseline|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694487|NCT01894984|P2|Participant Flow|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694488|NCT01894984|P1|Participant Flow|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694489|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694490|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694491|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694492|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694493|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694494|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694495|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694496|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694497|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694498|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694499|NCT01894984|O2|Outcome|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694500|NCT01894984|O1|Outcome|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694501|NCT01894984|E2|Reported Event|Oral Atypical Anti-psychotic|Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc was administered as per Investigator's discretion.
694502|NCT01894984|E1|Reported Event|Risperidone|Risperidone was administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose was decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may had been increased or decreased at Investigator's discretion. For first three weeks, previous oral antipsychotic drug (benzodiazepines or selective serotonin reuptake inhibitor [SSRI]) was maintained and ceased at Week 3.
694503|NCT01894906|B3|Baseline|Total|Total of all reporting groups
694504|NCT01894906|B2|Baseline|Gambro 17R/21R (Group 2: Polyamide Membrane).|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
694505|NCT01894906|B1|Baseline|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
694506|NCT01894906|P2|Participant Flow|Gambro 17R/21R (Group 2: Polyamide Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
694507|NCT01894906|P1|Participant Flow|Baxter CT-190 (Group 1: Cellulose Triacetate Membrane)|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate.
694508|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
694509|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
694510|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694511|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
694512|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694513|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694514|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
694515|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
694516|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694517|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
694518|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694519|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694520|NCT01894906|O1|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694521|NCT01894906|O3|Outcome|Baxter and Gambro Combined|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). This category includes the combined results of both groups.
694522|NCT01894906|O2|Outcome|Gambro Polyflux|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
694523|NCT01894906|O1|Outcome|Baxter CT-190|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane).
694524|NCT01894906|O6|Outcome|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
694525|NCT01894906|O5|Outcome|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
694526|NCT01894906|O4|Outcome|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694527|NCT01894906|O3|Outcome|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
694528|NCT01894906|O2|Outcome|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694529|NCT01894906|O1|Outcome|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694530|NCT01894906|E6|Reported Event|Treatment F|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new Gambro 17R/21R PAES membrane dialyzer.
694699|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694531|NCT01894906|E5|Reported Event|Treatment E|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment E was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, low blood flow rate, low dialysis flow rate, and new dialyzer.
694532|NCT01894906|E4|Reported Event|Treatment D|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment D was one dialysis session with SFP added to the bicarbonate, with low bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694533|NCT01894906|E3|Reported Event|Treatment C|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment C was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and re-used dialyzer.
694534|NCT01894906|E2|Reported Event|Treatment B|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment B was one dialysis session with SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694535|NCT01894906|E1|Reported Event|Control|Enrolled subjects were assigned to 1 of 2 groups based on the type of dialyzer membrane used by each subject at Screening: Baxter CT-190 (Group 1; N = 6; cellulose triacetate membrane) or Gambro 17R/21R (Group 2; N = 6; polyamide membrane). Within each dialyzer membrane group, each subject received one control treatment and 5 treatments with SFP added to dialysate. Treatment A was one dialysis session without SFP added to the bicarbonate, with standard bicarbonate concentration, blood flow rate, dialysis flow rate, and new dialyzer.
694536|NCT01894607|B1|Baseline|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
694537|NCT01894607|P1|Participant Flow|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
694538|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
694539|NCT01894607|O1|Outcome|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
694540|NCT01894607|E1|Reported Event|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before participant is given the contrast agent. Participant then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier.
694541|NCT01894581|B3|Baseline|Total|Total of all reporting groups
694542|NCT01894581|B2|Baseline|Normal Weight|BMI 18-25 kg/m2
694543|NCT01894581|B1|Baseline|Obese|BMI >= 30 kg/m2
694544|NCT01894581|P2|Participant Flow|Normal Weight|BMI 18-25 kg/m2
694545|NCT01894581|P1|Participant Flow|Obese|BMI >= 30 kg/m2
694546|NCT01894581|O2|Outcome|Normal Weight|BMI 18-25 kg/m2
694547|NCT01894581|O1|Outcome|Obese|BMI >= 30 kg/m2
694548|NCT01894581|E2|Reported Event|Normal Weight|BMI 18-25 kg/m2
694549|NCT01894581|E1|Reported Event|Obese|BMI >= 30 kg/m2
694550|NCT01894555|B1|Baseline|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
694551|NCT01894555|P1|Participant Flow|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
694552|NCT01894555|O1|Outcome|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
694553|NCT01894555|E1|Reported Event|Aspirin|"Participants treated with aspirin - there is no control group. Participant's baseline will act as their control.~Aspirin: 81 mg daily for 4 weeks"
694554|NCT01894256|B4|Baseline|Total|Total of all reporting groups
694555|NCT01894256|B3|Baseline|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694622|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694556|NCT01894256|B2|Baseline|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694557|NCT01894256|B1|Baseline|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694558|NCT01894256|P3|Participant Flow|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694559|NCT01894256|P2|Participant Flow|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694560|NCT01894256|P1|Participant Flow|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694561|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694562|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694563|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694564|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694565|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694566|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694567|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694568|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694569|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694570|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694571|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694572|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694573|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694574|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694575|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694696|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694576|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694577|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694578|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694579|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694580|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694581|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694582|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694583|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694584|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694585|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694586|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694587|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694588|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694589|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694590|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694591|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694592|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694593|NCT01894256|O1|Outcome|Normal Renal Function|Patients with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694594|NCT01894256|O3|Outcome|Moderate Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694595|NCT01894256|O2|Outcome|Mild Renal Impairment|"Patients with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694697|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694597|NCT01894256|E6|Reported Event|Part B Moderate Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694598|NCT01894256|E5|Reported Event|Part B Mild Renal Impairment|"Patient in Part B of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694599|NCT01894256|E4|Reported Event|Part B Normal Renal Function|Patients in Part B of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694600|NCT01894256|E3|Reported Event|Part A Moderate Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 31 to 50 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694601|NCT01894256|E2|Reported Event|Part A Mild Renal Impairment|"Patients in Part A of the study with stable renal impairment with calculated serum creatinine clearance 51 to 80 mL/min (using Cockcroft-Gault equation), for at least 2 months prior to the start of the study.~Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing)."
694602|NCT01894256|E1|Reported Event|Part A Normal Renal Function|Patients from Part A of the study with calculated serum creatinine clearance ≥81 mL/min (using Cockcroft-Gault equation). Received single dose of 300 mg olaparib (2 x 150 mg tablets) in fasted condition (1 hour before their olaparib dose until 2 hours after dosing).
694603|NCT01894100|B3|Baseline|Total|Total of all reporting groups
694604|NCT01894100|B2|Baseline|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694605|NCT01894100|B1|Baseline|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694606|NCT01894100|P2|Participant Flow|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694607|NCT01894100|P1|Participant Flow|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694608|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694698|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694609|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694610|NCT01894100|O2|Outcome|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694611|NCT01894100|O1|Outcome|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694612|NCT01894100|E2|Reported Event|Immediate Intervention Group|"At baseline, participants in this group will begin shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694613|NCT01894100|E1|Reported Event|Delayed Intervention Group|"This group will not receive shoe lifts during the first 3 months after baseline. At 3 months, they will begin the shoe lift correction for leg length inequality.~Shoe lift correction for leg length inequality: Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height."
694614|NCT01894022|B3|Baseline|Total|Total of all reporting groups
694615|NCT01894022|B2|Baseline|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694616|NCT01894022|B1|Baseline|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694617|NCT01894022|P2|Participant Flow|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694618|NCT01894022|P1|Participant Flow|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694619|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694620|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694621|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694859|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694623|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694624|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694625|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694626|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694627|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694628|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694629|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694630|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694631|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694632|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694633|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694634|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694635|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694636|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694637|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694638|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694639|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694640|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694641|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694642|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694643|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694644|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694645|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694646|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694647|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694648|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694649|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694650|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694651|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694652|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694653|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694654|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694655|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694656|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694657|NCT01894022|O2|Outcome|Ambrisentan 5 mg|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694658|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694659|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694660|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694661|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694662|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694663|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694664|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694665|NCT01894022|O2|Outcome|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694666|NCT01894022|O1|Outcome|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694667|NCT01894022|E2|Reported Event|Previous Ambrisentan|Participants received ambrisentan 5 mg tablet OD for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants continued to receive ambrisentan 5 mg OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694668|NCT01894022|E1|Reported Event|Previous Placebo|Participants received placebo tablet once daily (OD) for 16 weeks in study AMB115811. Upon enrollment in the extension study AMB116457, participants received ambrisentan 5 milligrams (mg) tablet OD. The dose could be up-titrated to ambrisentan 10 mg OD or adjusted back to ambrisentan 5 mg OD.
694669|NCT01893879|B3|Baseline|Total|Total of all reporting groups
694670|NCT01893879|B2|Baseline|Placebo for Study Drug|"Patients receive placebo three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
694671|NCT01893879|B1|Baseline|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug three times daily, orally, for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
694672|NCT01893879|P2|Participant Flow|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
694673|NCT01893879|P1|Participant Flow|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
694674|NCT01893879|O2|Outcome|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
694675|NCT01893879|O1|Outcome|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
694676|NCT01893879|E2|Reported Event|Placebo for Study Drug|"Patients receive placebo PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~placebo for study drug: Given PO~laboratory biomarker analysis: Correlative studies"
694677|NCT01893879|E1|Reported Event|(RS)2-(3-benzoylphenyl)-Propionic Acid|"Patients receive study drug PO TID for up to 1 year in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis will be performed.~(RS)2-(3-benzoylphenyl)-propionic acid: Given PO~laboratory biomarker analysis: Correlative studies"
694678|NCT01893567|B1|Baseline|Clobex Spray|Clobex Spray
694679|NCT01893567|P1|Participant Flow|Clobex Spray|Clobex Spray
694680|NCT01893567|O1|Outcome|Clobex Spray|Clobex Spray
694681|NCT01893567|E1|Reported Event|Clobex Spray|Clobex Spray
694682|NCT01893411|B4|Baseline|Total|Total of all reporting groups
694683|NCT01893411|B3|Baseline|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694684|NCT01893411|B2|Baseline|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694685|NCT01893411|B1|Baseline|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694686|NCT01893411|P3|Participant Flow|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694687|NCT01893411|P2|Participant Flow|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694688|NCT01893411|P1|Participant Flow|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694689|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694690|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694691|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694692|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694693|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694694|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694695|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
697466|NCT01873989|P2|Participant Flow|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
694700|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694701|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694702|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694703|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694704|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694705|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694706|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694707|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694708|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694709|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694710|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694711|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694712|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694713|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694714|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694715|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694716|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694717|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694718|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694719|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694720|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694721|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694722|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694723|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694724|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694725|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694726|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694821|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694727|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694728|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694729|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694730|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694731|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694732|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694733|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694734|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694735|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694736|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694737|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694738|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694739|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694740|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694741|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694742|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694743|NCT01893411|O3|Outcome|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 Units per injection treatment via intramuscular injection into spastic muscles.
694744|NCT01893411|O2|Outcome|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 Units per injection treatment via intramuscular injection into spastic muscles.
694745|NCT01893411|O1|Outcome|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 400 Units per injection treatment via intramuscular injection into spastic muscles.
694746|NCT01893411|E3|Reported Event|Low Dose: 4U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 4 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 100 U per injection treatment via intramuscular injection into spastic muscles.
694747|NCT01893411|E2|Reported Event|Mid Dose: 12 U/kg Body Weight Incobotulinumtoxin A (Xeomin)|Participants received 12 U/kg BW of IncobotulinumtoxinA (Xeomin) with a maximum of 300 U per injection treatment via intramuscular injection into spastic muscles.
694748|NCT01893411|E1|Reported Event|High Dose: 16 U/kg Body Weight IncobotulinumtoxinA (Xeomin)|Participants received 16 Unit per kilogram (U/kg) Body Weight (BW) of IncobotulinumtoxinA (Xeomin) with a maximum of 400 U per injection treatment via intramuscular injection into spastic muscles.
700413|NCT01853072|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
694765|NCT01893346|B5|Baseline|Total|Total of all reporting groups
694766|NCT01893346|B4|Baseline|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
694767|NCT01893346|B3|Baseline|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
694768|NCT01893346|B2|Baseline|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
694769|NCT01893346|B1|Baseline|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
694770|NCT01893346|P4|Participant Flow|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
694771|NCT01893346|P3|Participant Flow|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
694772|NCT01893346|P2|Participant Flow|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
694773|NCT01893346|P1|Participant Flow|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
694774|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
694775|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
694776|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
694777|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
694778|NCT01893346|O4|Outcome|Cohort 2 / Ceftazidime|aged ≥6 to <12 years
694779|NCT01893346|O3|Outcome|Cohort 2 / Avibactam|aged ≥6 to <12 years
694780|NCT01893346|O2|Outcome|Cohort 1 / Ceftazidime|aged ≥12 to <18 years / Ceftazidime
694781|NCT01893346|O1|Outcome|Cohort 1 / Avibactam|aged ≥12 to <18 years
694782|NCT01893346|E4|Reported Event|Cohort 4|"aged ≥3 months to <2 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
700414|NCT01853072|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
694783|NCT01893346|E3|Reported Event|Cohort 3|"aged ≥2 to <6 years Normal renal function or mild renal insufficiency: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam.~Moderate renal insufficiency: 25 mg/kg ceftazidime and 6.25 mg/kg avibactam"
694784|NCT01893346|E2|Reported Event|Cohort 2|aged ≥6 to <12 years Weight <40 kg: 50 mg/kg ceftazidime and 12.5 mg/kg avibactam Weight ≥40 kg: 2000 mg ceftazidime and 500 mg avibactam
694785|NCT01893346|E1|Reported Event|Cohort 1|aged ≥12 to <18 years 2000 mg ceftazidime and 500 mg avibactam
694786|NCT01893281|B1|Baseline|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
694787|NCT01893281|P1|Participant Flow|Topical Testosterone Solution|Testosterone, initially 60 milligrams (mg) once daily (QD), titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
694788|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
694789|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
694790|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
694791|NCT01893281|O1|Outcome|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
694792|NCT01893281|E1|Reported Event|Topical Testosterone Solution|Testosterone, initially 60 mg QD, titrated to effect as needed (range 30-120 mg QD), administered as a 2% topical solution for up to 9 weeks.
694793|NCT01893203|B1|Baseline|BF-200 ALA vs MAL|BF-200 ALA cream and MAL (Metvix, Galderma) used in a randomized split-face design
694794|NCT01893203|P1|Participant Flow|BF200 ALA vs MAL|5-aminulevulinic acid nanoemulsion (BF-200 ALA, Ameluz, Biofrontera) and methylaminolevulinic acid (MAL, Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
694795|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
694796|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
694797|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
694798|NCT01893203|O1|Outcome|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized split face design on symmetrical treatment areas.
694799|NCT01893203|E1|Reported Event|BF200 ALA vs MAL|BF-200 ALA (Ameluz, Biofrontera) and MAL (Metvix, Galderma) in randomized slipt face design on symmetrical treatment areas.
694800|NCT01892657|B1|Baseline|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
694801|NCT01892657|P1|Participant Flow|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
694802|NCT01892657|O13|Outcome|Challenge Patch (Alternate Site) - 96 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded again at 96 hours.
694803|NCT01892657|O12|Outcome|Challenge Patch (Alternate Site) - 48 Hours|A challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to an alternate application site was graded at 48 hours.
694804|NCT01892657|O11|Outcome|Challenge Patch (Original Site) - 96 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded again at 96 hours.
694805|NCT01892657|O10|Outcome|Challenge Patch (Original Site) - 48 Hours|The challenge patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+ applied to the original application site was graded at 48 hours.
694806|NCT01892657|O9|Outcome|Patch 9|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694807|NCT01892657|O8|Outcome|Patch 8|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694808|NCT01892657|O7|Outcome|Patch 7|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694809|NCT01892657|O6|Outcome|Patch 6|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694810|NCT01892657|O5|Outcome|Patch 5|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694811|NCT01892657|O4|Outcome|Patch 4|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694812|NCT01892657|O3|Outcome|Patch 3|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694813|NCT01892657|O2|Outcome|Patch 2|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694814|NCT01892657|O1|Outcome|Patch 1|Subjects received a patch dosed with 100 microliters of Cetaphil Daily Facial Moisturizer with SPF 50+
694815|NCT01892657|E1|Reported Event|Facial Moisturizer With SPF 50+|All subjects received Cetaphil Daily Facial Moisturizer with SPF 50+
694816|NCT01892306|B3|Baseline|Total|Total of all reporting groups
694817|NCT01892306|B2|Baseline|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694818|NCT01892306|B1|Baseline|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694819|NCT01892306|P2|Participant Flow|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694820|NCT01892306|P1|Participant Flow|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
730104|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
694822|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694823|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694824|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694825|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694826|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694827|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694828|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694829|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694830|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694831|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694832|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694833|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694834|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694835|NCT01892306|O2|Outcome|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694836|NCT01892306|O1|Outcome|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694837|NCT01892306|E2|Reported Event|Treatment as Usual|"Existing psychiatrist-administered psychopharmacotherapy~Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist"
694838|NCT01892306|E1|Reported Event|Treatment as Usual Plus UP CBT|"Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT~UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders"
694839|NCT01892267|B3|Baseline|Total|Total of all reporting groups
694840|NCT01892267|B2|Baseline|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694841|NCT01892267|B1|Baseline|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694842|NCT01892267|P2|Participant Flow|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694843|NCT01892267|P1|Participant Flow|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694844|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694845|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694846|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694847|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694848|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694849|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694850|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694851|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694852|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694853|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694854|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694855|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694856|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694857|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694860|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694861|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694862|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694863|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694864|NCT01892267|O2|Outcome|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694865|NCT01892267|O1|Outcome|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694866|NCT01892267|E2|Reported Event|Standard PEGJ Feeding Tube|"Patients in this arm will receive the standard commercially availabel PEGJ tube.~PEG-J placement: PEG-J placement"
694867|NCT01892267|E1|Reported Event|Self-propelled PEGJ Feeding Tube|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEG-J placement: PEG-J placement"
694868|NCT01892189|B10|Baseline|Total|Total of all reporting groups
694869|NCT01892189|B9|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694870|NCT01892189|B8|Baseline|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694871|NCT01892189|B7|Baseline|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694872|NCT01892189|B6|Baseline|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694873|NCT01892189|B5|Baseline|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694874|NCT01892189|B4|Baseline|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694927|NCT01892163|B1|Baseline|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
694928|NCT01892163|P2|Participant Flow|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
694929|NCT01892163|P1|Participant Flow|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
694875|NCT01892189|B3|Baseline|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694876|NCT01892189|B2|Baseline|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694877|NCT01892189|B1|Baseline|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
697467|NCT01873989|P1|Participant Flow|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
694878|NCT01892189|P9|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 30 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), , tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694879|NCT01892189|P8|Participant Flow|TAK-063 30 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694880|NCT01892189|P7|Participant Flow|Placebo + TAK-063 30 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694881|NCT01892189|P6|Participant Flow|TAK-063 300 mg/10 mg + Placebo + TAK-063 3 mg|TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694882|NCT01892189|P5|Participant Flow|TAK-063 3 mg + TAK-063 300 mg/10 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694883|NCT01892189|P4|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 300 mg/10 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 300 mg (participants enrolled before protocol amendment 3) or 10 mg (participants enrolled after protocol amendment 3), tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694884|NCT01892189|P3|Participant Flow|TAK-063 30 mg + Placebo + TAK-063 3 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694885|NCT01892189|P2|Participant Flow|TAK-063 3 mg + TAK-063 30 mg + Placebo|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694930|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
694931|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
694886|NCT01892189|P1|Participant Flow|Placebo + TAK-063 3 mg + TAK-063 30 mg|TAK-063 placebo-matching tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of first intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of second intervention period (1 day), followed by 7 days washout period, further followed by TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously once only on Day 1 of third intervention period (1 day).
694887|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
694888|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694889|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694890|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694891|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694892|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
694893|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694894|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694895|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694896|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694897|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
694898|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694899|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694900|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694901|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694902|NCT01892189|O5|Outcome|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
694903|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694904|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694905|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694906|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694907|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694908|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694909|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694910|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694911|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694912|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694913|NCT01892189|O3|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694914|NCT01892189|O2|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694915|NCT01892189|O1|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694916|NCT01892189|O4|Outcome|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694917|NCT01892189|O3|Outcome|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694918|NCT01892189|O2|Outcome|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694919|NCT01892189|O1|Outcome|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694920|NCT01892189|E5|Reported Event|TAK-063 300 mg|TAK-063 300 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 and 3.
694921|NCT01892189|E4|Reported Event|TAK-063 30 mg|TAK-063 30 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694922|NCT01892189|E3|Reported Event|TAK-063 10 mg|TAK-063 10 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in intervention period 1, 2 or 3.
694923|NCT01892189|E2|Reported Event|TAK-063 3 mg|TAK-063 3 mg, tablets, orally along with ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694924|NCT01892189|E1|Reported Event|Placebo|TAK-063 placebo-matching tablets, orally and ketamine, infusion, intravenously on Day 1 in either intervention period 1, 2 or 3.
694925|NCT01892163|B3|Baseline|Total|Total of all reporting groups
729493|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
694933|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
694934|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
694935|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
694936|NCT01892163|O2|Outcome|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
694937|NCT01892163|O1|Outcome|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
694938|NCT01892163|E2|Reported Event|Ozurdex Fixed Dosing|Ozurdex: Dexamethasone implant (Ozurdex)
694939|NCT01892163|E1|Reported Event|Ozurdex PRN Dosing|"Ozurdex PRN dosing versus Ozurdex fixed dosing~Ozurdex: Dexamethasone implant (Ozurdex)"
695019|NCT01891669|P1|Participant Flow|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
730105|NCT01694108|O2|Outcome|Control Children (no Intervention)|
694940|NCT01892020|B1|Baseline|All Subjects|In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences. Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). Group B received BHI 50 BID during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG).
694941|NCT01892020|P2|Participant Flow|Group B (BHI 50 - BIAsp 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group B received BHI 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BIAsp 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
694942|NCT01892020|P1|Participant Flow|Group A (BIAsp 50 - BHI 50)|"In this multi-center, randomized, open-labelled, 2-sequence, 2-period crossover trial, the eligible subjects were randomized to 2 groups to receive biphasic insulin aspart 50 (BIAsp 50) and biphasic human insulin 50 (BHI 50) in different sequences.~Group A received BIAsp 50 twice daily (BID) during the first 4 weeks (period 1), then switched to BHI 50 BID for further 4 weeks (period 2). BIAsp 50 (NovoMix® 50) was administered subcutaneously (s.c.) using NovoPen 4 immediately before breakfast and dinner. And BHI 50 was administered s.c. using NovoPen 4 at least 30 minutes before breakfast and dinner. All subjects received metformin throughout this trial. Insulin dose was adjusted twice weekly based on self-measured plasma glucose (SMPG)."
694943|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
694944|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
694945|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
694946|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
694947|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
694948|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
694949|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
694950|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
694951|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
694952|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
694953|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
694954|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
694955|NCT01892020|O2|Outcome|BHI 50|This arm included the subjects received BHI 50.
694956|NCT01892020|O1|Outcome|BIAsp 50|This arm included the subjects received BIAsp 50.
694957|NCT01892020|E2|Reported Event|BHI 50|This arm included the subjects received BHI 50.
694958|NCT01892020|E1|Reported Event|BIAsp 50|This arm included the subjects received BIAsp 50.
694959|NCT01891864|B3|Baseline|Total|Total of all reporting groups
694960|NCT01891864|B2|Baseline|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
694961|NCT01891864|B1|Baseline|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
694962|NCT01891864|P6|Participant Flow|Enbrel ® Etanercept Switched|"Enbrel ®/GP2015 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694963|NCT01891864|P5|Participant Flow|GP2015 Etanercept Switched|"GP2015/Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694964|NCT01891864|P4|Participant Flow|Enbrel ® Etanercept Continued|Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2) Enbrel ® 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2.
694965|NCT01891864|P3|Participant Flow|GP2015 Etanercept Continued|"GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 50 mg subcutaneous (s.c.) injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2"
694966|NCT01891864|P2|Participant Flow|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
694967|NCT01891864|P1|Participant Flow|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
694968|NCT01891864|O4|Outcome|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
695020|NCT01891669|O9|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
730106|NCT01694108|O1|Outcome|BCG-vaccine|
694969|NCT01891864|O3|Outcome|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694970|NCT01891864|O2|Outcome|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694971|NCT01891864|O1|Outcome|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694972|NCT01891864|O4|Outcome|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694973|NCT01891864|O3|Outcome|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694974|NCT01891864|O2|Outcome|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694975|NCT01891864|O1|Outcome|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694976|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
694977|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
694978|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
694979|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
694980|NCT01891864|O2|Outcome|Enbrel ® Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~Enbrel ® Etanercept"
694981|NCT01891864|O1|Outcome|GP2015 Etanercept|"Solution for subcutaneous injection in pre-filled syringe. The drug is administered in a dose of 50 mg twice weekly for the first 12 weeks and 50 mg once weekly thereafter~GP2015 Etanercept"
694982|NCT01891864|E4|Reported Event|Enbrel ® Etanercept Continued|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694983|NCT01891864|E3|Reported Event|GP2015 Etanercept Switched|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept /Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between Enbrel/GP2015/Enbrel (Treatment Period 2).~Enbrel ® Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
695295|NCT01890512|P1|Participant Flow|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
694984|NCT01891864|E2|Reported Event|Enbrel ® Etanercept Switched|"Enbrel ® Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~Enbrel ® Etanercept /GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug until Week 30. Three periods of 6 weeks alternating between GP2015/Enbrel/GP2015 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694985|NCT01891864|E1|Reported Event|GP2015 Etanercept Continued|"GP2015 Etanercept (s.c.) injection administered in a dose of 50 mg twice weekly for the first 12 weeks.~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 13 until Week 30 (Treatment Period 2).~GP2015 Etanercept 50 mg subcutaneous (s.c.) weekly injection of study drug from week 31 until Week 52 (Extension Period) in patients who had completed Treatment Period 2."
694986|NCT01891734|B3|Baseline|Total|Total of all reporting groups
695021|NCT01891669|O8|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695307|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
694987|NCT01891734|B2|Baseline|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
694988|NCT01891734|B1|Baseline|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
694989|NCT01891734|P2|Participant Flow|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
694990|NCT01891734|P1|Participant Flow|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
694991|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
694992|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
694993|NCT01891734|O2|Outcome|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
695010|NCT01891669|P10|Participant Flow|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695011|NCT01891669|P9|Participant Flow|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695012|NCT01891669|P8|Participant Flow|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
730195|NCT01692938|O2|Outcome|Retinal Disease|
694994|NCT01891734|O1|Outcome|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
694995|NCT01891734|O2|Outcome|Problem Solving Therapy|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward workbook.
695022|NCT01891669|O7|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695023|NCT01891669|O6|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
697468|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
694996|NCT01891734|O1|Outcome|Problem Solving Therapy-Moving Forward|Veterans in each group received 6-sessions of Problem Solving Therapy. Session 1 took place in-person immediately after the eligibility assessment and lasted for approximately 1 hour. Subsequent sessions took place over the telephone and lasted for approximately 30-45 minutes. As part of each PST session, participants completed the Patient Health Questionnaire-9 (PHQ-9; Kroenke, Spitzer & Williams, 2001) to evaluate on-going treatment effects and inquire about safety and suicidality. As part of the therapy, participants were asked to complete homework (psychoeducation about stress, information on effective problem solving and worksheets) using the Moving Forward app.
694997|NCT01891734|E2|Reported Event|Problem Solving Therapy|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.~Problem Solving Therapy: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes."
694998|NCT01891734|E1|Reported Event|Problem Solving Therapy Plus Moving Forward (PST-MF)|"All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from PST to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person PST or the Moving Forward website. The phone content matches PST. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.~Problem Solving Therapy plus Moving Forward: All Veterans will receive a standard 6-session administration of PST (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes"
694999|NCT01891669|B11|Baseline|Total|Total of all reporting groups
695000|NCT01891669|B10|Baseline|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695001|NCT01891669|B9|Baseline|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695002|NCT01891669|B8|Baseline|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695003|NCT01891669|B7|Baseline|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695004|NCT01891669|B6|Baseline|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695005|NCT01891669|B5|Baseline|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695006|NCT01891669|B4|Baseline|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695007|NCT01891669|B3|Baseline|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695008|NCT01891669|B2|Baseline|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695009|NCT01891669|B1|Baseline|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695677|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
695013|NCT01891669|P7|Participant Flow|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695014|NCT01891669|P6|Participant Flow|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695015|NCT01891669|P5|Participant Flow|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695016|NCT01891669|P4|Participant Flow|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695017|NCT01891669|P3|Participant Flow|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695018|NCT01891669|P2|Participant Flow|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695169|NCT01890954|B3|Baseline|Total|Total of all reporting groups
695024|NCT01891669|O5|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695025|NCT01891669|O4|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695026|NCT01891669|O3|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695027|NCT01891669|O2|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695028|NCT01891669|O1|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695029|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695030|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695031|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695032|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695033|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695034|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695035|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695036|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695037|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695038|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695039|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695040|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695041|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695042|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695043|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695044|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695045|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695046|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695047|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695048|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695049|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695050|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695051|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695052|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
700721|NCT01851330|B3|Baseline|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
695053|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695054|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695055|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695056|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695057|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695058|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695059|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695060|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695061|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695062|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695063|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695064|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695065|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695066|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695067|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695068|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695069|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695070|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695071|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695072|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695073|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695074|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695189|NCT01890915|E2|Reported Event|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695075|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695076|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695077|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695078|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695079|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695080|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695081|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
730107|NCT01694108|E2|Reported Event|Control Children (no Intervention)|
695082|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695083|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695084|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695085|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695086|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695087|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695088|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695089|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695090|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695091|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695092|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695093|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695094|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695095|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695096|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695097|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695098|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695099|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695100|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695101|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695102|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695103|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695104|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695105|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695106|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695107|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695108|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695109|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695110|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
730108|NCT01694108|E1|Reported Event|BCG-vaccine|
695111|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695112|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695113|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695114|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695115|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695116|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695117|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695118|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695119|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695120|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695121|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695122|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695123|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695124|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695125|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695126|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695127|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695128|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695129|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695130|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695131|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695132|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695133|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695134|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695135|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695136|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695137|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695138|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695139|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
730109|NCT01693900|B3|Baseline|Total|Total of all reporting groups
695140|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695141|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695142|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695143|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695144|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695145|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695146|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695147|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695148|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695149|NCT01891669|O10|Outcome|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695150|NCT01891669|O9|Outcome|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695151|NCT01891669|O8|Outcome|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695152|NCT01891669|O7|Outcome|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695153|NCT01891669|O6|Outcome|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695154|NCT01891669|O5|Outcome|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695155|NCT01891669|O4|Outcome|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695156|NCT01891669|O3|Outcome|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695157|NCT01891669|O2|Outcome|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695158|NCT01891669|O1|Outcome|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695159|NCT01891669|E10|Reported Event|PF-06263507 6.5 mg/kg|PF-06263507 6.5 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695160|NCT01891669|E9|Reported Event|PF-06263507 5.42 mg/kg|PF-06263507 5.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695161|NCT01891669|E8|Reported Event|PF-06263507 4.34 mg/kg|PF-06263507 4.34 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695162|NCT01891669|E7|Reported Event|PF-06263507 2.78 mg/kg|PF-06263507 2.78 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695163|NCT01891669|E6|Reported Event|PF-06263507 1.42 mg/kg|PF-06263507 1.42 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695164|NCT01891669|E5|Reported Event|PF-06263507 0.73 mg/kg|PF-06263507 0.73 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695165|NCT01891669|E4|Reported Event|PF-06263507 0.37 mg/kg|PF-06263507 0.37 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695166|NCT01891669|E3|Reported Event|PF-06263507 0.19 mg/kg|PF-06263507 0.19 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695167|NCT01891669|E2|Reported Event|PF-06263507 0.1 mg/kg|PF-06263507 0.1 mg/kg was administered on Day 1 of each 21-day cycle as an IV infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695168|NCT01891669|E1|Reported Event|PF-06263507 0.05 mg/kg|PF-06263507 0.05 mg/kg was administered on Day 1 of each 21-day cycle as an intravenous (IV) infusion over approximately 60 minutes. A cycle was defined as the time from Day 1 dose to the next Day 1 dose.
695170|NCT01890954|B2|Baseline|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
695171|NCT01890954|B1|Baseline|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
695172|NCT01890954|P2|Participant Flow|Closed Loop Control First, Then Usual Care|8 hours observational (09:00-17:00) using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
695173|NCT01890954|P1|Participant Flow|Usual Care First, Then Closed Loop Control|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00). 1 day of wash-out. 8 hours using Closed Loop Control with DiAs with a missed insulin bolus for 30g of carbohydrates snack (09:00) and an under-bolus (75% meal insulin with no correction insulin) for an 80g lunch (13:00).
695174|NCT01890954|O2|Outcome|Usual Care Without DiAs System (CGM Only)|8 hours observational (09:00-17:00) during usual care with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
695175|NCT01890954|O1|Outcome|Closed Loop Control With DiAs System|8 hours observational (09:00-17:00) during closed-loop control (DiAs) with a missed insulin bolus for 30g carbohydrates snack (09:00) and an under-bolus (75% meal insulin with full correction insulin) for an 80g lunch (13:00).
695176|NCT01890954|E2|Reported Event|Usual Care Without DiAs System (CGM Only)|8 hours observational under both, missed insulin bolus for 30 gr carbohydrates snack and under bolus for an 80 gr carbohydrates lunch.
695177|NCT01890954|E1|Reported Event|Closed Loop Control With DiAs System|"8 hours using Closed Loop Control with DiAs under both, miss insulin bolus for 30 grams of carbohydrates snack or under bolus for an 80 grams of carbohydrates lunch~Diabetes Assistant (DiAs)"
695178|NCT01890915|B3|Baseline|Total|Total of all reporting groups
695179|NCT01890915|B2|Baseline|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695180|NCT01890915|B1|Baseline|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695181|NCT01890915|P2|Participant Flow|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695182|NCT01890915|P1|Participant Flow|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, American Spinal Injury Association (ASIA) impairment levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695183|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695184|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695185|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695186|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695187|NCT01890915|O2|Outcome|Control|"Age and gender-matched able-bodied controls. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695188|NCT01890915|O1|Outcome|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695219|NCT01890746|B3|Baseline|Total|Total of all reporting groups
730196|NCT01692938|O1|Outcome|No Retinal Disease|
695190|NCT01890915|E1|Reported Event|Tetraplegia|"Persons with spinal cord injury, level of injury C4-T1, ASIA levels A-B and duration of injury greater than 1 year. Ages 18-65 years old.~Heat Exposure: Heat exposure of 95 degrees F for up to 2 hours."
695191|NCT01890785|B7|Baseline|Total|Total of all reporting groups
695192|NCT01890785|B6|Baseline|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
695193|NCT01890785|B5|Baseline|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
695194|NCT01890785|B4|Baseline|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
695195|NCT01890785|B3|Baseline|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
695308|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
695196|NCT01890785|B2|Baseline|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
695197|NCT01890785|B1|Baseline|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
695198|NCT01890785|P6|Participant Flow|Sequence 6|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
695199|NCT01890785|P5|Participant Flow|Sequence 5|Lisdexamfetamine Dimesylate 70mg intact capsule fasting for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
695200|NCT01890785|P4|Participant Flow|Sequence 4|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for third intervention
695201|NCT01890785|P3|Participant Flow|Sequence 3|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
695202|NCT01890785|P2|Participant Flow|Sequence 2|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for first intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for second intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for third intervention
695203|NCT01890785|P1|Participant Flow|Sequence 1|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice for first intervention; then Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt for second intervention; then Lisdexamfetamine Dimesylate 70mg intact capsule fasting for third intervention
695204|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
695205|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
695206|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
695207|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
695208|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
695209|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
695210|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|lisdexamfetamine dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
695211|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
695212|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
695213|NCT01890785|O3|Outcome|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
695214|NCT01890785|O2|Outcome|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt (Single dose of a 70 mg capsule on Day 1)
695215|NCT01890785|O1|Outcome|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
695216|NCT01890785|E3|Reported Event|Lisdexamfetamine Dimesylate Intact Capsule Fasting|Lisdexamfetamine Dimesylate 70 mg capsule administered under fasted conditions (Single dose of a 70 mg capsule on Day 1)
695217|NCT01890785|E2|Reported Event|Lisdexamfetamine Dimesylate Mixed in Vanilla Yogurt|Lisdexamfetamine Dimesylate 70mg capsule mixed into vanilla yogurt(Single dose of a 70 mg capsule on Day 1)
695218|NCT01890785|E1|Reported Event|Lisdexamfetamine Dimesylate Mixed in Orange Juice|Lisdexamfetamine Dimesylate 70mg capsule mixed into orange juice (Single dose of a 70 mg capsule on Day 1)
695220|NCT01890746|B2|Baseline|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695221|NCT01890746|B1|Baseline|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695309|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695310|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
731086|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
695222|NCT01890746|P2|Participant Flow|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695223|NCT01890746|P1|Participant Flow|Eltrombopag (ELT) QD|Par. received (rec) first line induction (IDN) chemotherapy (CTY) consisting of daunorubicin (DAU) bolus intravenous (IV) infusion (INF) on Days (D) 1-3 at a dose of 90 milligrams (mg)/square meter (m^2) for Par. 18-60 year (yr) or 60 mg/m^2 for >60 yr plus cytarabine (CB) 100 mg/m^2 continuous IV INF on D1-7. Par. rec ELT as 200 mg (100 mg for East-Asian Heritage [EAH]) once daily (QD) oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If platelet (PT) count was not >100 Giga (Gi)/Liter (L) after 7D the dose was increased to 300 mg (150 mg for EAH) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42D from the start of the CTY IDN cycle. Par. not aplastic after first cycle of IDN CTY rec re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus CB 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695224|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695225|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695226|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695227|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695228|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695229|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695293|NCT01890577|E1|Reported Event|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
730197|NCT01692938|O2|Outcome|Retinal Disease|
695230|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695231|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695232|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695311|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695233|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695234|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695235|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695236|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695237|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695238|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695239|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695240|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695294|NCT01890512|B1|Baseline|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
695241|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695242|NCT01890746|O2|Outcome|Placebo QD|Participants received first line IDN CTY consisting of DAU bolus IV INF on Days 1-3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants >60 years of age plus cytarabine continuous IV INF on Days 1-7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose starting on Day 4 of initial IDN CTY at least 20 hours after end of Day 3 DAU INF up to a maximum duration of 42 days.
695269|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695270|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695312|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695243|NCT01890746|O1|Outcome|Eltrombopag QD|Par. received IDN CTY consisting of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.>60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg (100 mg for East-Asian Heritage) QD oral dose starting on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not >100 Gi/L after 7 days the dose was increased to 300 mg (150 mg East-Asian Heritage) QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par. who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695244|NCT01890746|E2|Reported Event|Placebo QD|Participants received first line induction chemotherapy consisted of daunorubicin bolus IV infusion on Days 1 – 3 at a dose of 90 mg/m^2 for participants 18-60 years old or 60 mg/m^2 for participants &gt;60 years of age plus cytarabine continuous IV infusion on Days 1 – 7 at a dose of 100 mg/m^2. Participants received placebo QD oral dose started on Day 4 of initial induction chemotherapy at least 20 hours after end of Day 3 daunorubicin infusion up to a maximum duration of 42 days.
695245|NCT01890746|E1|Reported Event|Eltrombopag QD|Par. received IDN CTY of DAU bolus IV INF on D 1-3 at a dose of 90 mg/m^2 for Par. 18-60 years old or 60 mg/m^2 for Par.&gt;60 years old plus cytarabine 100 mg/m^2 continuous IV INF on D1-7. Par. received ELT as 200 mg QD oral dose started on D4 of initial IDN CTY at least 20 hours after end of D3 DAU INF. If PT count was not &gt;100 Gi/L after 7 days the dose was increased to 300 mg QD until a PT count of at least 200 Gi/L was achieved, until remission was assessed by bone marrow biopsy, or for a maximum of 42 days from the start of the CTY IDN cycle. Par.who were not aplastic after first cycle of IDN CTY received re-IDN with a modified DAU dose of 45mg/m^2/day on D1-3 plus cytarabine 100 mg/m^2/day on D1-7. For re-IDN Par., ELT was held from D1-3 of re-IDN, and resumed on D4 at the same dose and duration.
695246|NCT01890694|B3|Baseline|Total|Total of all reporting groups
695247|NCT01890694|B2|Baseline|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
695248|NCT01890694|B1|Baseline|Placebo|Subjects will receive placebo once daily.
695249|NCT01890694|P2|Participant Flow|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
695250|NCT01890694|P1|Participant Flow|Placebo|Subjects will receive placebo once daily.
695251|NCT01890694|O1|Outcome|Tolvaptan|Subjects will receive Tolvaptan once daily.
695252|NCT01890694|O2|Outcome|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
695253|NCT01890694|O1|Outcome|Placebo|Subjects will receive placebo once daily.
695254|NCT01890694|E2|Reported Event|Tolvaptan|Subjects will receive 15 mg Tolvaptan once daily.
695255|NCT01890694|E1|Reported Event|Placebo|Subjects will receive placebo once daily.
695256|NCT01890642|B4|Baseline|Total|Total of all reporting groups
695257|NCT01890642|B3|Baseline|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695258|NCT01890642|B2|Baseline|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695259|NCT01890642|B1|Baseline|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695260|NCT01890642|P3|Participant Flow|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695261|NCT01890642|P2|Participant Flow|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695262|NCT01890642|P1|Participant Flow|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695678|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
695263|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695264|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695265|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695266|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695267|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695268|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695271|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695272|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695273|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695274|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695275|NCT01890642|O3|Outcome|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695276|NCT01890642|O2|Outcome|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695277|NCT01890642|O1|Outcome|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695278|NCT01890642|E3|Reported Event|J Tip|"This group will receive 1% buffered lidocaine via Jet Injection. They will receive placebo cooling spray (normal saline spray) to maintain blinding~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~1% buffered lidocaine: Lidocaine placed using Jet Injection~placebo cooling spray (normal saline spray): Normal Saline Sprayed as placebo for Pain Ease spray"
695279|NCT01890642|E2|Reported Event|Pain Ease|"This group will receive Pain Ease Spray~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695280|NCT01890642|E1|Reported Event|J Tip Noise|"This group will have a J tip deployed without medication to create the noise that the device makes. They will also receive Pain Ease spray~J tip: This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine~Pain Ease Spray: Cold Spray used to anesthetize the skin"
695281|NCT01890577|B1|Baseline|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695282|NCT01890577|P1|Participant Flow|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695283|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695284|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695285|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695286|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695287|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695288|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695289|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695290|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695291|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695292|NCT01890577|O1|Outcome|Aranesp®|Participants receiving Aranesp® (darbepoetin alfa) for at least 3 months prior to enrolment and according to the local prescribing guidelines.
695296|NCT01890512|O1|Outcome|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
695297|NCT01890512|E1|Reported Event|ImageReady Pacemaker|patients previously implanted with a Boston Scientific MR Conditional pacemaker(ImageReady)
695298|NCT01890473|B3|Baseline|Total|Total of all reporting groups
695299|NCT01890473|B2|Baseline|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
695300|NCT01890473|B1|Baseline|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
695301|NCT01890473|P2|Participant Flow|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
695302|NCT01890473|P1|Participant Flow|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
695303|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695304|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695305|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695306|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695313|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695314|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695315|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695316|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695317|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695318|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695319|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
695320|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
695321|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe.
695322|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695323|NCT01890473|O2|Outcome|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a Prefilled Syringe (PFS).
695324|NCT01890473|O1|Outcome|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered subcutaneously (SC) via an autoinjector.
695325|NCT01890473|E2|Reported Event|125 mg Abatacept Via Prefilled Syringe|A single dose of 125 mg abatacept was administered SC via a PFS.
695326|NCT01890473|E1|Reported Event|125 mg Abatacept Via Autoinjector|A single dose of 125 mg abatacept was administered SC via an autoinjector.
695327|NCT01890343|B4|Baseline|Total|Total of all reporting groups
695328|NCT01890343|B3|Baseline|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695329|NCT01890343|B2|Baseline|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695330|NCT01890343|B1|Baseline|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
695331|NCT01890343|P3|Participant Flow|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695332|NCT01890343|P2|Participant Flow|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695333|NCT01890343|P1|Participant Flow|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
695334|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695335|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695336|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
695337|NCT01890343|O3|Outcome|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695338|NCT01890343|O2|Outcome|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695339|NCT01890343|O1|Outcome|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
695340|NCT01890343|E3|Reported Event|Alzheimer's Disease|"Subjects with Alzheimer's disease (AD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695679|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
695341|NCT01890343|E2|Reported Event|Cognitively Normal|"Cognitively normal (CN) subjects.~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F."
695342|NCT01890343|E1|Reported Event|Frontotemporal Disorder|"Subjects with frontotemporal disorder (FTD).~florbetapir 18F: Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.~18F-FDG: FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG."
695343|NCT01890148|B1|Baseline|AZD5069|AZD5069 45mg oral twice daily (BID)
695344|NCT01890148|P1|Participant Flow|AZD5069|AZD5069 45mg oral twice daily (BID)
695345|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695346|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695347|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695348|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695349|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695350|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695351|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695352|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695353|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695354|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695355|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695356|NCT01890148|O1|Outcome|AZD5069|AZD5069 45mg oral twice daily (BID)
695360|NCT01890122|B4|Baseline|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695361|NCT01890122|B3|Baseline|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695362|NCT01890122|B2|Baseline|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695363|NCT01890122|B1|Baseline|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695364|NCT01890122|P4|Participant Flow|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695365|NCT01890122|P3|Participant Flow|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695366|NCT01890122|P2|Participant Flow|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695367|NCT01890122|P1|Participant Flow|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695368|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695369|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695370|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695371|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695372|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695373|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695374|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695375|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695376|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695377|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695378|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695464|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
730198|NCT01692938|O1|Outcome|No Retinal Disease|
695379|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695380|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695381|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695382|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695383|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695384|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695385|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695386|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695387|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695388|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695389|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695390|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695391|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695392|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695393|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695394|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695395|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695396|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695397|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695398|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695399|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695400|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695401|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695402|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695403|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695404|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695680|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
695405|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695406|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695407|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695408|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695409|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695410|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695411|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
700957|NCT01849692|P1|Participant Flow|Cohort 1 - ESBA|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg)
695412|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695413|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695414|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695415|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695416|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695417|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695418|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695419|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695420|NCT01890122|O4|Outcome|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695421|NCT01890122|O3|Outcome|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695422|NCT01890122|O2|Outcome|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695423|NCT01890122|O1|Outcome|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695424|NCT01890122|E4|Reported Event|Placebo|Alogliptin and metformin FDC placebo-matching tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695425|NCT01890122|E3|Reported Event|Alogliptin 12.5 mg + Metformin HCl 500 mg FDC|Alogliptin 12.5 mg and metformin HCl 500 mg FDC, tablets, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day for up to 26 weeks.
695426|NCT01890122|E2|Reported Event|Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, twice a day; metformin placebo-matching capsules, orally, twice a day; alogliptin and metformin HCl FDC placebo-matching tablets, orally, twice a day for up to 26 weeks.
695427|NCT01890122|E1|Reported Event|Metformin HCl 500 mg|Metformin hydrochloride (HCl) 500 mg, capsules, orally, twice a day; alogliptin placebo-matching tablets, orally, twice a day; alogliptin and metformin HCl fixed dose combination (FDC) placebo-matching tablets, orally, twice a day for up to 26 weeks.
695428|NCT01890031|B6|Baseline|Total|Total of all reporting groups
695429|NCT01890031|B5|Baseline|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
695430|NCT01890031|B4|Baseline|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695465|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
695431|NCT01890031|B3|Baseline|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695432|NCT01890031|B2|Baseline|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
695433|NCT01890031|B1|Baseline|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
695434|NCT01890031|P5|Participant Flow|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
695435|NCT01890031|P4|Participant Flow|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695436|NCT01890031|P3|Participant Flow|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695437|NCT01890031|P2|Participant Flow|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
695438|NCT01890031|P1|Participant Flow|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
695439|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
695440|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695441|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695442|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
695443|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
695444|NCT01890031|O5|Outcome|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
695445|NCT01890031|O4|Outcome|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695446|NCT01890031|O3|Outcome|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695447|NCT01890031|O2|Outcome|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
695448|NCT01890031|O1|Outcome|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
695449|NCT01890031|E5|Reported Event|Low Risk, ICAT, and Study Physician|Low risk, assigned to use the Interactive Cholesterol Advisory Tool, and study physician visits
695450|NCT01890031|E4|Reported Event|Moderate Risk, ICAT|"Moderate risk, study physician visits, and randomized to use the Interactive Cholesterol Advisory Tool~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education.~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695451|NCT01890031|E3|Reported Event|Moderate Risk, no ICAT|"Moderate risk, study physician visits, and not randomized to use the Interactive Cholesterol Advisory Tool~Study physician visits: In-person individual visits with a study physician to give information on cholesterol"
695452|NCT01890031|E2|Reported Event|Low Risk, ICAT|"Low risk, randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits~Interactive Cholesterol Advisory Tool: using the virtual clinician computer program for cholesterol information and education."
695453|NCT01890031|E1|Reported Event|Low Risk, No ICAT|Low risk, not randomized to use the Interactive Cholesterol Advisory Tool, no study physician visits
695454|NCT01889797|B3|Baseline|Total|Total of all reporting groups
695455|NCT01889797|B2|Baseline|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
695456|NCT01889797|B1|Baseline|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
695457|NCT01889797|P2|Participant Flow|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
695458|NCT01889797|P1|Participant Flow|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
695459|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
695460|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
695461|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
695462|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
695463|NCT01889797|O2|Outcome|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
695466|NCT01889797|O1|Outcome|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
695467|NCT01889797|E2|Reported Event|Arm B: GA101|"GA101 1,000 mg IV weekly for 4 weeks.~Arm B: GA101: GA101 1,000 mg (flat dose) IV x 4 weekly doses."
695468|NCT01889797|E1|Reported Event|Arm A: Rituximab|"Rituximab 375 mg/m² IV weekly for 4 weeks.~Arm A: Rituximab: Rituximab 375 mg/m² IV x 4 weekly doses."
695469|NCT01889667|B4|Baseline|Total|Total of all reporting groups
695470|NCT01889667|B3|Baseline|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695471|NCT01889667|B2|Baseline|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
695472|NCT01889667|B1|Baseline|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
695473|NCT01889667|P3|Participant Flow|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695474|NCT01889667|P2|Participant Flow|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
695475|NCT01889667|P1|Participant Flow|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
695476|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695477|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
695478|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
695479|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695480|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
695481|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
695482|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695483|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
695484|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
695485|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695486|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation 8 mg + 16 mg capsules"
695487|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation 8mg + 8 mg capsules"
695488|NCT01889667|O3|Outcome|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695489|NCT01889667|O2|Outcome|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation"
695490|NCT01889667|O1|Outcome|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation"
695491|NCT01889667|E3|Reported Event|Placebo|"Oil Capsules~Placebo: Oil Capsules"
695492|NCT01889667|E2|Reported Event|ORMD-0801 Dose # 2|"Oral Insulin Formulation~ORMD-0801 Dose # 2: Oral Insulin Formulation (24 mg)"
695493|NCT01889667|E1|Reported Event|ORMD-0801 Dose # 1|"Oral Insulin Formulation~ORMD-0801 Dose # 1: Oral Insulin Formulation (16 mg)"
695494|NCT01889563|B3|Baseline|Total|Total of all reporting groups
695495|NCT01889563|B2|Baseline|No Physical Exercise Training Program|No Physical Exercise Training Program
695496|NCT01889563|B1|Baseline|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
695497|NCT01889563|P2|Participant Flow|No Physical Exercise Training Program|No Physical Exercise Training Program
695498|NCT01889563|P1|Participant Flow|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
695499|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
695500|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
695501|NCT01889563|O2|Outcome|No Physical Exercise Training Program|No Physical Exercise Training Program
695502|NCT01889563|O1|Outcome|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
695503|NCT01889563|E2|Reported Event|No Physical Exercise Training Program|No Physical Exercise Training Program
695504|NCT01889563|E1|Reported Event|Physical Exercise Training Program|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
695505|NCT01889420|B1|Baseline|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
695506|NCT01889420|P1|Participant Flow|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
695555|NCT01888367|B2|Baseline|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
695556|NCT01888367|B1|Baseline|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
695507|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
695508|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
695509|NCT01889420|O1|Outcome|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
695510|NCT01889420|E1|Reported Event|Combination Therapy|"Pomalidomide: 1 tablet orally, daily for 21 days of a 28 day cycle (dose per cohort) Everolimus: 1 tablet orally for 21 days of a 28 day cycle (dose as per cohort) Dexamethasone 40 mg (20 mg >75yrs) orally, days 1, 8,15, 22 of a 28 day cycle~Combination therapy: Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.~Cycles will span 28 days. Dosage schedules will be:~Everolimus daily for 28 days of a 28 day cycle;~Pomalidomide daily for 21 days of a 28 day cycle~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
695511|NCT01889251|B3|Baseline|Total|Total of all reporting groups
695512|NCT01889251|B2|Baseline|Sham Injection|Single sham injection to the study eye at baseline
695513|NCT01889251|B1|Baseline|Ocriplasmin|Single intravitreal injection to the study eye at baseline
695514|NCT01889251|P2|Participant Flow|Sham Injection|Single sham injection to the study eye at baseline
695515|NCT01889251|P1|Participant Flow|Ocriplasmin|Single intravitreal injection to the study eye at baseline
695516|NCT01889251|O2|Outcome|Sham Injection|Single sham injection to the study eye at baseline
695517|NCT01889251|O1|Outcome|Ocriplasmin|Single intravitreal injection to the study eye at baseline
695518|NCT01889251|E2|Reported Event|Sham Injection|Single sham injection to the study eye at baseline
695519|NCT01889251|E1|Reported Event|Ocriplasmin|Single intravitreal injection to the study eye at baseline
695520|NCT01888965|B1|Baseline|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
695521|NCT01888965|P1|Participant Flow|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
695522|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
695523|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
695524|NCT01888965|O1|Outcome|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
695681|NCT01887470|O4|Outcome|Regimen B for PM Colonoscopy|"Regimen B for afternoon colonoscopy~Regimen B"
695525|NCT01888965|E1|Reported Event|Dovitinib|"Dovitinib 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years~Dovitinib: All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years."
695526|NCT01888952|B1|Baseline|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
695557|NCT01888367|P3|Participant Flow|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
695558|NCT01888367|P2|Participant Flow|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
695559|NCT01888367|P1|Participant Flow|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
695560|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
695527|NCT01888952|P1|Participant Flow|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
695528|NCT01888952|O1|Outcome|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
695529|NCT01888952|E1|Reported Event|Roflumilast and Prednisone|"Roflumilast 500 mcg will be administered orally daily for 21 consecutive days (a 21-day cycle).~In Cycle 1, prednisone 60 mg/m2 up to a maximum of 100 mg oral (PO) daily will be taken on Days 8 through 14 at the same time as roflumilast.~In Cycle 2 and subsequent cycles, prednisone 60 mg/m2 PO up to a maximum of 100 mg daily will be taken on Days 1 through 7 at the same time as roflumilast.~Prednisone: Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.~Roflumilast: Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease."
695530|NCT01888900|B3|Baseline|Total|Total of all reporting groups
695531|NCT01888900|B2|Baseline|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695532|NCT01888900|B1|Baseline|Hepatitis C Virus Genotype 1A|subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695533|NCT01888900|P2|Participant Flow|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695534|NCT01888900|P1|Participant Flow|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695535|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695536|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695537|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695538|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695539|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695540|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695541|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695542|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695543|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695544|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695545|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695546|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695547|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695548|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695549|NCT01888900|O2|Outcome|Hepatitis C Virus Genotype 1B|Patients will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks.
695550|NCT01888900|O1|Outcome|Hepatitis C Virus Genotype 1A|Patients will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.
695551|NCT01888900|E2|Reported Event|Hepatitis C Virus Genotype 1B|"subjects will receive combination therapy with asunaprevir and daclatasvir alone for 24 weeks and undergo paired liver biopsies, pre-treatment and either at 2 or 4 weeks after starting therapy.~Asunaprevir and Daclatsvir"
695552|NCT01888900|E1|Reported Event|Hepatitis C Virus Genotype 1A|"Subjects will be started on combination therapy with asunaprevir, daclatasvir, peginterferon alfa-2a and ribavirin for 24 weeks.~Asunaprevir, daclatsvir, peginterferon, ribavirin"
695553|NCT01888367|B4|Baseline|Total|Total of all reporting groups
695554|NCT01888367|B3|Baseline|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
695793|NCT01886690|E2|Reported Event|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
695561|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
695562|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
695563|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
695564|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
695565|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
695566|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
695567|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
695568|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
695569|NCT01888367|O3|Outcome|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
695570|NCT01888367|O2|Outcome|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
695571|NCT01888367|O1|Outcome|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
695572|NCT01888367|E3|Reported Event|Standard of Care|Prior to final closure of the surgical incision, the incision will be irrigated with normal saline and no gel will be applied.
695573|NCT01888367|E2|Reported Event|DFA-02 Placebo Gel|"Up to 20 mL of DFA-02 placebo gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Placebo Gel"
695574|NCT01888367|E1|Reported Event|DFA-02 Antibiotic Gel|"Up to 20 mL of DFA-02 antibiotic gel will be placed in the surgical incision after closure of the fascia and before skin closure.~DFA-02 Antibiotic Gel"
695575|NCT01888003|B4|Baseline|Total|Total of all reporting groups
695576|NCT01888003|B3|Baseline|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695577|NCT01888003|B2|Baseline|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695620|NCT01887678|B1|Baseline|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695670|NCT01887470|P2|Participant Flow|Full Dose Preparation; PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
695578|NCT01888003|B1|Baseline|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
695579|NCT01888003|P3|Participant Flow|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695580|NCT01888003|P2|Participant Flow|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695599|NCT01887990|B3|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed, opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
695581|NCT01888003|P1|Participant Flow|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
695582|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695583|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695584|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
695585|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695671|NCT01887470|P1|Participant Flow|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
695672|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
695586|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695587|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
695588|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695600|NCT01887990|B2|Baseline|Suicidal, Depression With Saline|"suicidal and depressed, no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
695601|NCT01887990|B1|Baseline|Suicidal, Depression With Ketamine|"suicidal and depressed, no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
695602|NCT01887990|P4|Participant Flow|Suicidal, Depression With Opioid Use With Saline|suicidal, depression with opioid use, given saline IV
695589|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695590|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
695591|NCT01888003|O3|Outcome|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695592|NCT01888003|O2|Outcome|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695621|NCT01887678|P2|Participant Flow|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695673|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
695674|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
695593|NCT01888003|O1|Outcome|Anemia Treatment Group (AMG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has"
695594|NCT01888003|E3|Reported Event|Non Anemia Group (NAG)|"Group of patients who are not anemic preoperatively, who will receive our current, conventional perioperative standard of care.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695595|NCT01888003|E2|Reported Event|Conventional Treatment Group (CTG)|"Group of patients who are diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive our current, conventional perioperative standard of care, which does not involve any preoperative anemia management (other than laboratory testing). CTG patients will undergo routine perioperative laboratory testing/screening.~Blood Transfusion: An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability."
695596|NCT01888003|E1|Reported Event|Anemia Treatment Group (AMG)|"Patients diagnosed preoperatively as being anemic (defined as a Hgb < 13.0 g/dL and MCV < 100 fL, with a hematocrit between 30% and 39%, for males and females), who will receive an ESA (PROCRIT) and iron (Venofer) preoperatively.~Iron sucrose: AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days and −7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.~Epoetin Alfa: AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at −14 days, −7 days before their planned surgery, and if indicated, based on labs, testing on the day of their surgery"
695597|NCT01887990|B5|Baseline|Total|Total of all reporting groups
695598|NCT01887990|B4|Baseline|Suicidal, Depression and Opioid Use With Ketamine|"suicidal and depressed,opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
695603|NCT01887990|P3|Participant Flow|Suicidal, Depression and Opioid Use With Ketamine|suicidal, depressed with opioid use, given 0.2 mg/kg ketamine one time dose IV infusion
695604|NCT01887990|P2|Participant Flow|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
695605|NCT01887990|P1|Participant Flow|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose in patients with suicidal ideatin and depression without substance use~Ketamine"
695606|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|suicidal patients who use opioids who received saline infusion or placebo
695607|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal pts who have used opioids, in the ketamine treatment arm
695608|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
695609|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
695610|NCT01887990|O4|Outcome|Suicidal, Opioid Use With Saline|Patients with suicidal ideation and depression with opioid use disorder who are given comparable amount of placebo (saline) as would have been used with the Ketamine arm
695611|NCT01887990|O3|Outcome|Suicidal, Opioid Use With Ketamine|suicidal ideation,depression, opioid use disorder 0.2 mg/kg IV ketamine one time dose
695612|NCT01887990|O2|Outcome|Suicidal, Depression With Saline|"comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
695613|NCT01887990|O1|Outcome|Suicidal, Depression With Ketamine|"0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
695614|NCT01887990|E4|Reported Event|Suicidal, Depression and Opioid With Saline|"Suicidal with depression and opioid use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
695615|NCT01887990|E3|Reported Event|Suicidal, Depression and Opioid Use With Ketamine|"Suicidal with depression and opioid use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
695616|NCT01887990|E2|Reported Event|Suicidal, Depression With Saline|"Suicidal with depression and no substance use comparable amount of placebo (saline) as would have been used with the Ketamine arm~placebo"
695617|NCT01887990|E1|Reported Event|Suicidal, Depression With Ketamine|"Suicidal with depression and no substance use 0.2 mg/kg IV ketamine administered as a one time dose~Ketamine"
695618|NCT01887678|B3|Baseline|Total|Total of all reporting groups
695619|NCT01887678|B2|Baseline|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695675|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution.
695676|NCT01887470|O1|Outcome|Lactulose for Oral Solution|All patients taking lactulose for oral solution
695622|NCT01887678|P1|Participant Flow|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695623|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695624|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695625|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695626|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695627|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
697469|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
695628|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695629|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695630|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695631|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695632|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695633|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695634|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695635|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695669|NCT01887470|P3|Participant Flow|Split Dose Preparation; AM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
730199|NCT01692938|E2|Reported Event|Retinal Disease|
695636|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695637|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695638|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695639|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695640|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695641|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695642|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695643|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695644|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695645|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695646|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695647|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695648|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695649|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695650|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695651|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695652|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695653|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695654|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695655|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695656|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695657|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695658|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695659|NCT01887678|O2|Outcome|Placebo Injectable Solution|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695660|NCT01887678|O1|Outcome|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695661|NCT01887678|E2|Reported Event|Placebo Injectable Solution|At baseline, patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a placebo injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695662|NCT01887678|E1|Reported Event|Co-administered Traumeel® and Zeel®|Patients with documented diagnosis of primary osteoarthritis of the based on clinical and radiographic criteria (Kellgren-Lawrence Numerical Grading System of Grade 2-3) in the tibial-femoral compartment with an age of between 45 to 80 years and the ability to understand the explanations and instructions given by the study physician got a Traumeel/Zeel injection solution administered once weekly into the target knee on Study Days 1, 8 and 15.
695663|NCT01887470|B5|Baseline|Total|Total of all reporting groups
695664|NCT01887470|B4|Baseline|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
695665|NCT01887470|B3|Baseline|Split Dose Preparation; AM Colonscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated prior to noon.
695666|NCT01887470|B2|Baseline|Full Dose Preparation: PM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated after noon.
695667|NCT01887470|B1|Baseline|Full Dose Preparation; AM Colonoscopy|Four hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure. The colonoscopy is initiated prior to noon.
695668|NCT01887470|P4|Participant Flow|Split Dose Preparation; PM Colonoscopy|Three hourly doses of lactulose for oral solution are taken in the evening prior to the day of the colonoscopy procedure; one dose is taken on the morning of the procedure. The colonoscopy is initiated after noon.
695682|NCT01887470|O3|Outcome|Regimen B for AM Colonoscopy|"Regimen B for morning colonoscopy~Regimen B"
695683|NCT01887470|O2|Outcome|Regimen A for PM Colonoscopy|"Regimen A for afternoon colonoscopy~Regimen A"
695684|NCT01887470|O1|Outcome|Regimen A for AM Colonoscopy|"Regimen A for morning colonoscopy~Regimen A"
695685|NCT01887470|E1|Reported Event|Lactulose for Oral Solution|All patients taking lactulose for oral solution were evaluated as one group for purposes of providing survey data on the use of the product as a bowel preparation agent for colonoscopy.
695686|NCT01887418|B4|Baseline|Total|Total of all reporting groups
695687|NCT01887418|B3|Baseline|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
695688|NCT01887418|B2|Baseline|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
695689|NCT01887418|B1|Baseline|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week for 6 weeks"
695690|NCT01887418|P3|Participant Flow|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
695691|NCT01887418|P2|Participant Flow|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
695692|NCT01887418|P1|Participant Flow|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
695693|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
695694|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
695695|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
695696|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
695697|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
695698|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
695699|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
695700|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
695701|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
695702|NCT01887418|O3|Outcome|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: Standard of care"
695703|NCT01887418|O2|Outcome|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone"
695704|NCT01887418|O1|Outcome|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone"
695705|NCT01887418|E3|Reported Event|Delatestryl 200 mg IM Treatment C|"Commercially available Testosterone enanthate 200 mg IM dosage - 'standard of care' arm for reference~Delatestryl 200 mg IM Treatment C: injected once only"
695706|NCT01887418|E2|Reported Event|QuickShot™ - 50 mg Treatment B|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 50 mg Treatment B: QuickShot™ for the delivery of testosterone once a week."
695707|NCT01887418|E1|Reported Event|QuickShot™ - 100 mg Treatment A|"QuickShot™ - Auto-injector device for SC use~QuickShot™ - 100 mg Treatment A: QuickShot™ for the delivery of testosterone once a week"
695708|NCT01887353|B3|Baseline|Total|Total of all reporting groups
695709|NCT01887353|B2|Baseline|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
695710|NCT01887353|B1|Baseline|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
695711|NCT01887353|P2|Participant Flow|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
695712|NCT01887353|P1|Participant Flow|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
695713|NCT01887353|O2|Outcome|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
695714|NCT01887353|O1|Outcome|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
695715|NCT01887353|E2|Reported Event|Placebo|Placebo: Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
695716|NCT01887353|E1|Reported Event|Ranolazine|Ranolazine: Patients will take ranolazine 1000 mg tablets twice daily
695717|NCT01887171|B3|Baseline|Total|Total of all reporting groups
695718|NCT01887171|B2|Baseline|HTK Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
695745|NCT01886807|E3|Reported Event|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
695746|NCT01886807|E2|Reported Event|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
730200|NCT01692938|E1|Reported Event|No Retinal Disease|
695719|NCT01887171|B1|Baseline|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
695720|NCT01887171|P2|Participant Flow|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
695760|NCT01886716|B2|Baseline|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695761|NCT01886716|B1|Baseline|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
695721|NCT01887171|P1|Participant Flow|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
695722|NCT01887171|O2|Outcome|HTK Solution Only|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
695723|NCT01887171|O1|Outcome|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
695724|NCT01887171|E2|Reported Event|HTK Solution|During back-table operation 1000 ml of HTK solution cooled to 2-4˚C would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin under gravity pressure of 40 cm H2O.
695725|NCT01887171|E1|Reported Event|Tacrolimus + HTK|"During back-table operation 1000 ml of HTK solution cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.~Tacrolimus: 1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O."
695726|NCT01886963|B3|Baseline|Total|Total of all reporting groups
695727|NCT01886963|B2|Baseline|SPY - Unblinded Use of SPY Elite|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
695728|NCT01886963|B1|Baseline|Control - Blinded Use of SPY Elite|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
695747|NCT01886807|E1|Reported Event|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
695748|NCT01886781|B3|Baseline|Total|Total of all reporting groups
695749|NCT01886781|B2|Baseline|Placebo|Controls Crytalline cellulose powder
695750|NCT01886781|B1|Baseline|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
695751|NCT01886781|P2|Participant Flow|Placebo|Controls Crytalline cellulose powder
695752|NCT01886781|P1|Participant Flow|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
695729|NCT01886963|P2|Participant Flow|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
695730|NCT01886963|P1|Participant Flow|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded Use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
695762|NCT01886716|P4|Participant Flow|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
695794|NCT01886690|E1|Reported Event|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695731|NCT01886963|O2|Outcome|Group B|"Group B will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~VHR with Advancement Flaps with Unblinded Use of Spy Elite (Experimental): Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
695732|NCT01886963|O1|Outcome|Group A|"Group A will consist of intraoperative abdominal wall imaging prior to incision, followed by ventral hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Ventral Hernia Repair with Advancement Flaps with Blinded Use of Spy Elite (Control): Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
695733|NCT01886963|E2|Reported Event|Control - Blinded Use of SPY Elite|"Control - Blinded use of SPY Elite will consist of intraoperative abdominal wall imaging prior to incision, followed by ventra l hernia repair with subcutaneous advancement flaps without viewing the imaging contained within the Spy Elite system. A digital photograph will be taken before and immediately after initial incision, as well as immediately prior to and after closure. The patient will have digital photographs of the surgical wound taken by the surgical team daily until discharge, and on follow-up visits at one week, two weeks, four weeks and twelve weeks. After twenty patients have completed phase I, the surgical team will be unblinded to Spy Elite imaging. The Spy Elite imaging and all digital photographs of all patients will be reviewed.~Control - Blinded Use of Spy Elite: Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone"
695734|NCT01886963|E1|Reported Event|SPY - Unblinded Use of SPY Elite|"SPY - Unblinded use of SPY Elite will have incision and advancement flap performed based on assessment of blood supply using the Spy Elite system, as well as potential flap revision if portions of the flap appear under-perfused in the pre-closure imaging. Patients will be blinded to if intraoperative Spy Elite imaging was used. Digital photographs of the surgical wound taken by surgical team daily until discharge, and on follow-up visits post-operatively. Digital photographs will be reviewed by a blinded surgeon, who will assess the wound for complications (breakdown, necrosis, erythema, infection, or dehiscence with location specified) and assessment of healing. Upon study completion, groups will be compared for wound complications, presence of flap necrosis, quantification of flap necrosis, and healing speed.~SPY - Unblinded use of Spy Elite: Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging"
695735|NCT01886807|B4|Baseline|Total|Total of all reporting groups
695736|NCT01886807|B3|Baseline|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
695737|NCT01886807|B2|Baseline|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
695738|NCT01886807|B1|Baseline|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
695739|NCT01886807|P3|Participant Flow|(VL Group)|nasotracheal intubation using the Truview PCD video laryngoscope
695740|NCT01886807|P2|Participant Flow|(DL-O2 Group)|direct laryngoscopy for nasotracheal intubation with oxygen insufflation
695741|NCT01886807|P1|Participant Flow|(DL Group)|direct laryngoscopy for nasotracheal intubation without oxygen insufflation
695742|NCT01886807|O3|Outcome|(VL Group)|"nasotracheal intubation using the Truview PCD video laryngoscope~TrueView PCD Video Laryngoscope"
695743|NCT01886807|O2|Outcome|(DL-O2 Group)|"direct laryngoscopy for nasotracheal intubation with oxygen insufflation~TrueView PCD Video Laryngoscope"
695744|NCT01886807|O1|Outcome|(DL Group)|"direct laryngoscopy for nasotracheal intubation without oxygen insufflation~TrueView PCD Video Laryngoscope"
695754|NCT01886781|O1|Outcome|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
695755|NCT01886781|E2|Reported Event|Placebo|Controls Crytalline cellulose powder
695756|NCT01886781|E1|Reported Event|Lactobacillus Plantarum 299v|Treatment Lactobacillus plantarum 299v
695757|NCT01886716|B5|Baseline|Total|Total of all reporting groups
695758|NCT01886716|B4|Baseline|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
695759|NCT01886716|B3|Baseline|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695792|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695763|NCT01886716|P3|Participant Flow|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695764|NCT01886716|P2|Participant Flow|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695765|NCT01886716|P1|Participant Flow|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
695766|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
695767|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695768|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695769|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
695770|NCT01886716|O4|Outcome|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
695771|NCT01886716|O3|Outcome|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695772|NCT01886716|O2|Outcome|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695773|NCT01886716|O1|Outcome|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
695774|NCT01886716|E4|Reported Event|Control Training|"Participants will receive placebo Anxiety Training and placebo Alcohol training.~Control Training: Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol."
695775|NCT01886716|E3|Reported Event|Anxiety + Alcohol Attention Training|"Participants will receive both Anxiety Attention Training and Alcohol Attention Training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695776|NCT01886716|E2|Reported Event|Alcohol Attention Training Only|"Participants will receive Alcohol Attention Training and placebo Anxiety training.~Alcohol Attention Training: Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol."
695777|NCT01886716|E1|Reported Event|Anxiety Attention Training Only|"Participants will receive Anxiety Attention Training and placebo Alcohol training.~Anxiety Attention Training: Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety."
695778|NCT01886690|B3|Baseline|Total|Total of all reporting groups
695779|NCT01886690|B2|Baseline|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
695780|NCT01886690|B1|Baseline|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695781|NCT01886690|P2|Participant Flow|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
695782|NCT01886690|P1|Participant Flow|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695783|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
696154|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
695784|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695785|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
695786|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695787|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
695788|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695789|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
695790|NCT01886690|O1|Outcome|New Eye Drop Formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
695791|NCT01886690|O2|Outcome|REFRESH PLUS®|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
695796|NCT01886313|B2|Baseline|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
695797|NCT01886313|B1|Baseline|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
695798|NCT01886313|P2|Participant Flow|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
695799|NCT01886313|P1|Participant Flow|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
695800|NCT01886313|O2|Outcome|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
695801|NCT01886313|O1|Outcome|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
695802|NCT01886313|E2|Reported Event|Double Blind Treatment Period Placebo Nasal Spray|"Placebo Nasal Spray 10ul in each nostril, twice daily, for 6 weeks~Placebo"
695803|NCT01886313|E1|Reported Event|Double Blind Treatment Period Civamide Nasal Spray|"Civamide Nasal Spray 0.01% 20ug/dose (20ul), 10ul in each nostril, twice daily, for 6 weeks~Civamide Nasal Spray"
695804|NCT01886300|B1|Baseline|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695805|NCT01886300|P1|Participant Flow|Peginterferon Alfa-2a|Participants with hepatitis B envelope antigen (HBeAg) positive chronic hepatitis B who received peginterferon alfa-2a [Pegasys] were included.
695806|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695807|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695808|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695809|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695810|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695811|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695812|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695813|NCT01886300|O1|Outcome|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695814|NCT01886300|E1|Reported Event|Peginterferon Alfa-2a|Participants with HBeAg positive chronic hepatitis B who received peginterferon alfa-2a were included.
695815|NCT01886287|B1|Baseline|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
695816|NCT01886287|P1|Participant Flow|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
695817|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
695818|NCT01886287|O1|Outcome|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
695819|NCT01886287|E1|Reported Event|Octreotide Long-acting Release (LAR)|"Octreotide LAR will be administered at a dose of 60 mg intramuscularly (IM) every 4 weeks.~Octreotide LAR: Octreotide LAR as outlined in Treatment Arm."
695820|NCT01886235|B1|Baseline|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695821|NCT01886235|P1|Participant Flow|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695822|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695847|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
730201|NCT01692782|B4|Baseline|Total|Total of all reporting groups
695823|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695824|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695825|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695826|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
697470|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
695827|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695828|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695829|NCT01886235|O1|Outcome|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695830|NCT01886235|E1|Reported Event|Diagnosis (Intravital Microscopy)|"Patients receive fluorescein sodium IV followed by intravital microscopic observation over 10-15 minutes during excision of the melanoma.~Diagnostic Microscopy: Undergo intravital microscopy~Fluorescein Sodium Injection: Given IV~Laboratory Biomarker Analysis: Correlative studies~Therapeutic Conventional Surgery: Undergo surgery"
695831|NCT01885910|B1|Baseline|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695832|NCT01885910|P1|Participant Flow|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
695833|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695834|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695835|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695836|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695837|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695838|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695839|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695840|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695841|NCT01885910|O2|Outcome|Aczone/Doxy - Non Inflammatory|non inflammatory lesion counts during treatment with aczone 5% and doxy 100mg
695842|NCT01885910|O1|Outcome|Aczone/Doxy - Inflammatory|inflammatory lesion counts during treatment with aczone 5% and doxycycline 100mg
695843|NCT01885910|O1|Outcome|Aczone/Doxy|subjects will take doxy 100mg daily and apply aczone 5% gel to the face twice daily for 12 weeks after which if their acne has improved they will continue on maintenance therapy of aczone gel for another 12 weeks
695844|NCT01885910|E1|Reported Event|Doxy + Aczone|"Subjects will start treatment with doxycycline 100mg once daily and Aczone 5% gel applied to the face twice daily~Doxycycline 100mg and Aczone 5% gel: Subject is to take Doxycycline 100mg by mouth once daily and apply Aczone 5% gel to their face twice daily for 12 weeks; those subjects achieving treatment response will stop Doxycycline and continue applying Aczone 5% gel twice daily for 12 more weeks."
695845|NCT01885871|B1|Baseline|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
695846|NCT01885871|P1|Participant Flow|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
695848|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
695849|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
695850|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
695851|NCT01885871|O1|Outcome|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
695852|NCT01885871|E1|Reported Event|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser|Picosecond Q-Switched Nd:YAG 1064/532 nm Laser: Up to 2 laser treatments delivered 6 weeks apart
695853|NCT01885559|B3|Baseline|Total|Total of all reporting groups
695854|NCT01885559|B2|Baseline|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695952|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695855|NCT01885559|B1|Baseline|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695856|NCT01885559|P2|Participant Flow|ACE-I + Angiotensin Receptor Blocker (ARB)|"ACE-I + angiotensin receptor blocker (ARB) and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695857|NCT01885559|P1|Participant Flow|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695858|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695859|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695860|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695861|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695862|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695863|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695864|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695865|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695866|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695867|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695868|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695869|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695870|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695871|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695872|NCT01885559|O2|Outcome|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695873|NCT01885559|O1|Outcome|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695874|NCT01885559|E2|Reported Event|ACE-I + ARB|"ACE-I + ARB and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695875|NCT01885559|E1|Reported Event|ACE-I + Placebo|"ACE-I + placebo and standard blood pressure control of 110-130/80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg."
695876|NCT01885117|B3|Baseline|Total|Total of all reporting groups
695877|NCT01885117|B2|Baseline|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695953|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695878|NCT01885117|B1|Baseline|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695879|NCT01885117|P2|Participant Flow|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695880|NCT01885117|P1|Participant Flow|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695881|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695882|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695883|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695884|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695885|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695886|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695887|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695888|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695889|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695890|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695891|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695892|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695893|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695894|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695895|NCT01885117|O2|Outcome|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695896|NCT01885117|O1|Outcome|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695897|NCT01885117|E2|Reported Event|TIVf (≥ 61 Years)|Adult subjects aged ≥ 61 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695898|NCT01885117|E1|Reported Event|TIVf (18 to ≤ 60 Years)|Adult subjects aged 18 to ≤ 60 years received one dose of trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVf), formulation 2013/2014 Northern Hemisphere
695899|NCT01885104|B3|Baseline|Total|Total of all reporting groups
695900|NCT01885104|B2|Baseline|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695901|NCT01885104|B1|Baseline|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695902|NCT01885104|P2|Participant Flow|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695903|NCT01885104|P1|Participant Flow|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695904|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695905|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695906|NCT01885104|O2|Outcome|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695907|NCT01885104|O1|Outcome|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695908|NCT01885104|E2|Reported Event|Placebo|Participants received a 17 g dose of Placebo solution concentrate solution in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695909|NCT01885104|E1|Reported Event|PEG 3350|Participants received a 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days. Bisacodyl laxative tablets, 5.0 mg, 1 to 3 tablets in a single daily dose, were provided for use as a rescue medication if a participant had not had a bowel movement for 72 hours after start of treatment.
695910|NCT01885000|B3|Baseline|Total|Total of all reporting groups
695911|NCT01885000|B2|Baseline|Vehicle|once-daily brimonidine tartrate vehicle gel
695912|NCT01885000|B1|Baseline|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
695913|NCT01885000|P2|Participant Flow|Vehicle|once-daily brimonidine tartrate vehicle gel
695914|NCT01885000|P1|Participant Flow|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
695915|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
695916|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
695917|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
695918|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
695919|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
695920|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
695921|NCT01885000|O2|Outcome|Vehicle|once-daily brimonidine tartrate vehicle gel
695922|NCT01885000|O1|Outcome|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
695923|NCT01885000|E2|Reported Event|Vehicle|once-daily brimonidine tartrate vehicle gel
695924|NCT01885000|E1|Reported Event|Brimonidine Tartrate 0.5% Gel|once-daily brimonidine tartrate 0.5% gel
695925|NCT01884688|B1|Baseline|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
695926|NCT01884688|P1|Participant Flow|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
695927|NCT01884688|O1|Outcome|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
695928|NCT01884688|E1|Reported Event|ENK Cell Infusion|"Expanded Natural Killer Cell Infusion~ENK Cell Infusion: Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU"
695929|NCT01884675|B3|Baseline|Total|Total of all reporting groups
695930|NCT01884675|B2|Baseline|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695931|NCT01884675|B1|Baseline|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695932|NCT01884675|P2|Participant Flow|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695933|NCT01884675|P1|Participant Flow|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695934|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695935|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695936|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695937|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695938|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695939|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.c
695940|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695941|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
731062|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
695942|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695943|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695944|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695945|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695946|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695947|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695948|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695949|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695950|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695951|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
697471|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
695954|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695955|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695956|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695957|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695958|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695959|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695960|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695961|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695962|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695963|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695964|NCT01884675|O2|Outcome|Ambrisentan 5mg|Subjects in this arm will receive ambrisentan-matching placebo tablet once daily during the treatment period.
695965|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695966|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695967|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695968|NCT01884675|O2|Outcome|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695969|NCT01884675|O1|Outcome|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695970|NCT01884675|E2|Reported Event|Ambrisentan 5mg|Participants received an ambrisentan 5milligram (mg) tablet, once daily for a period of 16 weeks.
695971|NCT01884675|E1|Reported Event|Placebo|Participants received a matching placebo tablet once daily for a period of 16 weeks.
695972|NCT01884519|B3|Baseline|Total|Total of all reporting groups
695973|NCT01884519|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695974|NCT01884519|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695975|NCT01884519|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695976|NCT01884519|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695977|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695978|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695979|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695980|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695981|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695982|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695983|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696097|NCT01883427|P1|Participant Flow|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
695984|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695985|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695986|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695987|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695988|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695989|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
697472|NCT01873989|O2|Outcome|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
695990|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccinationars Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695991|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695992|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695993|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695994|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695995|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695996|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695997|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695998|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
695999|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696000|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696001|NCT01884519|O4|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696002|NCT01884519|O3|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696003|NCT01884519|O2|Outcome|Fluarix/Influsplit 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696004|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2 influenza seasonal prior to season 2012-2013. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696005|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696006|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696007|NCT01884519|O2|Outcome|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696008|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696009|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696010|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696011|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696279|NCT01880840|E1|Reported Event|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
696012|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696013|NCT01884519|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696014|NCT01884519|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696015|NCT01884519|E2|Reported Event|Fluarix/Influsplit &gt; 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696016|NCT01884519|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2013-2014 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696017|NCT01884064|B3|Baseline|Total|Total of all reporting groups
696018|NCT01884064|B2|Baseline|Sham rTMS|"Sham Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~Sham rTMS: Sham rTMS"
696019|NCT01884064|B1|Baseline|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
696020|NCT01884064|P2|Participant Flow|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
696021|NCT01884064|P1|Participant Flow|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
696022|NCT01884064|O2|Outcome|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
696023|NCT01884064|O1|Outcome|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
696024|NCT01884064|E2|Reported Event|Sham rTMS|"Sham or Placebo Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
696025|NCT01884064|E1|Reported Event|rTMS|"Repetitive Transcranial Magnetic stimulation: 1 Hz rTMS, 1800 pulses, delivered to premotor cortex during active hand movement. Intervention was delivered every day for 5 days.~rTMS: rTMS"
696026|NCT01883999|B1|Baseline|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
696027|NCT01883999|P1|Participant Flow|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
696028|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
696029|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
696030|NCT01883999|O1|Outcome|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
696031|NCT01883999|E1|Reported Event|GORE® EXCLUDER® Iliac Branch Endoprosthesis|GORE® EXCLUDER® Iliac Branch Endoprosthesis
696032|NCT01883986|B3|Baseline|Total|Total of all reporting groups
696033|NCT01883986|B2|Baseline|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
696034|NCT01883986|B1|Baseline|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
696035|NCT01883986|P2|Participant Flow|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
696071|NCT01883635|E2|Reported Event|Dyadic Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
696036|NCT01883986|P1|Participant Flow|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
696037|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
696038|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
696039|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
696078|NCT01883453|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
696040|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
696041|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
696042|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
696043|NCT01883986|O2|Outcome|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
696044|NCT01883986|O1|Outcome|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
696045|NCT01883986|E2|Reported Event|Usual Care|Subjects randomized to usual care will receive medical oncology, radiation oncology, pulmonary, CT surgery as indicated by the type of cancer. At the completion of 3 months of usual care, subjects are invited to join the intervention arm.
696046|NCT01883986|E1|Reported Event|Intervention|"This is a 3 month nurse-led telephone based program integrating palliative care into usual oncologic care for patients diagnosed within 2 months of any type and stage of lung cancer.~Palliative Care: Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient."
696047|NCT01883908|B3|Baseline|Total|Total of all reporting groups
696048|NCT01883908|B2|Baseline|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696049|NCT01883908|B1|Baseline|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696050|NCT01883908|P2|Participant Flow|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696051|NCT01883908|P1|Participant Flow|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696052|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696053|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696054|NCT01883908|O2|Outcome|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696079|NCT01883453|O1|Outcome|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
696280|NCT01880736|B5|Baseline|Total|Total of all reporting groups
697473|NCT01873989|O1|Outcome|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
696055|NCT01883908|O1|Outcome|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696056|NCT01883908|E2|Reported Event|Usual Medical Care|"Participants will be randomized to receive usual medical care for 8 weeks coinciding with their chemoradiation treatments. Patients will receive usual medical care such as viscous Lidocaine for relief of pain.~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696057|NCT01883908|E1|Reported Event|Acupuncture With Seirin® Needles|"Participants will be randomized to receive acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Acupuncture with Seirin® needles: Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).~Usual medical care: usual medical care such as viscous Lidocaine for relief of pain"
696058|NCT01883635|B3|Baseline|Total|Total of all reporting groups
696059|NCT01883635|B2|Baseline|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696060|NCT01883635|B1|Baseline|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696061|NCT01883635|P2|Participant Flow|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696062|NCT01883635|P1|Participant Flow|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696063|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696064|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696065|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696066|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696067|NCT01883635|O2|Outcome|Dyadic Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696068|NCT01883635|O1|Outcome|Individual Exercise Intervention|"Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)~Progressive walking and resistance exercise program"
696069|NCT01883635|E4|Reported Event|Dyadic Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed to both cancer survivors and their caregivers (daily walking and resistance prescription for 6 weeks)
696070|NCT01883635|E3|Reported Event|Individual Exercise Intervention - Caregivers|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
696151|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696072|NCT01883635|E1|Reported Event|Individual Exercise Intervention - Cancer Survivors|Progressive walking and resistance exercise treatment, prescribed solely to cancer survivors (daily walking and resistance prescription for 6 weeks)
696073|NCT01883453|B3|Baseline|Total|Total of all reporting groups
696074|NCT01883453|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
696075|NCT01883453|B1|Baseline|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
696076|NCT01883453|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
696077|NCT01883453|P1|Participant Flow|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
696104|NCT01882907|B1|Baseline|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
696080|NCT01883453|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"A nasal spray with 200U/ml of glucose oxidase + 5% glucose. Treatment starts with 5 puffs in each nostril at the first day, and thereafter trhee times daily for a total treatment time of one week.~Glucose oxidase+5%glucose: A hydrogen peroxide producing enzyme"
696081|NCT01883453|E1|Reported Event|Saline+Glucose Nasal Spray|"A nasal spray with isotone saline + 5% glucose, dosing one puff 5 times daily in each nostril at the first treatment day and thereafter trice daily for a total of one week~Saline+5%glucose: Isotonic saline + 5% glucose in a bag-on-valve nasal spray device"
696082|NCT01883440|B3|Baseline|Total|Total of all reporting groups
696083|NCT01883440|B2|Baseline|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
696084|NCT01883440|B1|Baseline|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
696085|NCT01883440|P2|Participant Flow|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
696086|NCT01883440|P1|Participant Flow|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
696087|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
696088|NCT01883440|O1|Outcome|Saline+Glucose|A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week
696089|NCT01883440|O2|Outcome|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
696090|NCT01883440|O1|Outcome|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
696091|NCT01883440|E2|Reported Event|Glucose Oxidase + Glucose|"A nasal spray (bag-on-valve device) with 200U/ml glucose oxidase + 5% glucose in isotone saline. One puff in each nostril 5 times daily day one and 3 times daily thereafter. A total treatment time of one week.~Glucose oxidase + glucose: Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device"
696092|NCT01883440|E1|Reported Event|Saline+Glucose|"A nasal spray with isotone saline + 5% glucose in a bag-on-valve nasal spray device. The spray will be administered with one puff in each nostril 5 times day one and thereafter trice daily for a total treatment time of one week~saline+glucose: Isotone saline+5%glucose in a bag-on-valve nasal spray device"
696093|NCT01883427|B3|Baseline|Total|Total of all reporting groups
696094|NCT01883427|B2|Baseline|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
696095|NCT01883427|B1|Baseline|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
696096|NCT01883427|P2|Participant Flow|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
696098|NCT01883427|O2|Outcome|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
696099|NCT01883427|O1|Outcome|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
696100|NCT01883427|E2|Reported Event|Nasal Spray With Glucose Oxidase+Glucose|"Nasal spray in a bag-on-valve device with 50U/ml glucose oxidase + 5% glucose in isotone saline. Dosage: One puff in each nostril twice daily for 3 months.~Glucose oxidase: Glucose oxidase is a hydrogen peroxide producing enzyme, imitating the inhibitory effects of the normal bacterial flora of the nasopharynx"
696101|NCT01883427|E1|Reported Event|Saline+Glucose Nasal Spray|"Nasal spray with saline+glucose twice daily for 3 months~Saline + glucose: A bag on valve nasal spray device containing isotone saline and 5% glucose"
696102|NCT01882907|B3|Baseline|Total|Total of all reporting groups
696103|NCT01882907|B2|Baseline|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
696534|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696105|NCT01882907|P2|Participant Flow|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
696106|NCT01882907|P1|Participant Flow|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
696107|NCT01882907|O2|Outcome|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
696108|NCT01882907|O1|Outcome|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
696109|NCT01882907|E2|Reported Event|Pioglitazone|"Pioglitazone add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~Pioglitazone: Pioglitazone 15mg bid for 16 weeks"
696110|NCT01882907|E1|Reported Event|Vildagliptin|"vildagliptin add-on the therapy to metformin in patients with type 2 diabetes inadequately controlled with metformin monotherapy~vildagliptin: vildagliptin 50mg bid for 16 weeks"
696111|NCT01882868|B1|Baseline|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696112|NCT01882868|P1|Participant Flow|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg intravenous (IV) infusion (1-2 hours) on Day 1 of Cycle 1 and every 2 weeks (q2w) thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until disease progression (DP), unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696113|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696114|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696115|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696116|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696117|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696118|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696152|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696153|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696119|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696120|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696121|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696167|NCT01882465|P6|Participant Flow|Hefilcon A/Etafilcon A /2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the etafilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
696122|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696123|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696124|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696125|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696126|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696127|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696128|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696129|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696130|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696131|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696132|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696133|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696134|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696135|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696168|NCT01882465|P5|Participant Flow|Hefilcon A/2-HEMA, EGDMA Non-ionic/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the hefilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
696136|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696137|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696138|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696139|NCT01882868|O1|Outcome|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696140|NCT01882868|E1|Reported Event|Aflibercept + FOLFIRI|Aflibercept 4 mg/kg IV infusion (1-2 hours) on Day 1 of Cycle 1 and q2w thereafter, in combination with FOLFIRI regimen on Days 1-3 of Cycle 1 and q2w thereafter until DP, unacceptable toxicity or participant's refusal. FOLFIRI regimen: IV infusions of levofolinate 200 mg/m^2 (2 hours) and irinotecan 180 mg/m^2 (90 minutes) simultaneously, followed by 5-FU 400 mg/m^2 IV bolus injection followed by continuous IV infusion of 5-FU (46 hours) at 2400 mg/m^2.
696141|NCT01882725|B1|Baseline|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
696142|NCT01882725|P1|Participant Flow|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
696143|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
696144|NCT01882725|O1|Outcome|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
696145|NCT01882725|E1|Reported Event|Erchonia HP Scanner (HPS)|"The Erchonia HP Scanner (HPS) Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HP Scanner (HPS): The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
696146|NCT01882647|B3|Baseline|Total|Total of all reporting groups
696147|NCT01882647|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696148|NCT01882647|B1|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696149|NCT01882647|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696150|NCT01882647|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696155|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696156|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696157|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696158|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696159|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696160|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696161|NCT01882647|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696162|NCT01882647|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696163|NCT01882647|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
696164|NCT01882647|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
696165|NCT01882465|B1|Baseline|Overall|All subjects that were enrolled into the study.
696166|NCT01882465|P7|Participant Flow|Not Assigned|Subjects that signed the inform consent, but them withdrew consent, prior to lens dispensing.
696271|NCT01880840|B3|Baseline|Total|Total of all reporting groups
696169|NCT01882465|P4|Participant Flow|2-HEMA, EGDMA Non-ionic/Hefilcon A/Etafilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the hefilcon A lens second and the etafilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
696170|NCT01882465|P3|Participant Flow|2-HEMA, EGDMA Non-ionic/Etafilcon A/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the 2-HEMA, EGDMA Non-ionic material lens first, the etafilcon A lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
696171|NCT01882465|P2|Participant Flow|Etafilcon A/Hefilcon A/2-HEMA, EGDMA Non-ionic|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the hefilcon A lens second and the 2-HEMA, EGDMA Non-ionic material lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
696172|NCT01882465|P1|Participant Flow|Etafilcon A/2-HEMA, EGDMA/Hefilcon A|Subjects were randomized to one of six unique sequences. Subjects randomized to this sequence will wear the etafilcon A lens first, the 2-HEMA, EGDMA Non-ionic material lens second and the hefilcon A lens third. The lenses are to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
696173|NCT01882465|O3|Outcome|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
696174|NCT01882465|O2|Outcome|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
696175|NCT01882465|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
696176|NCT01882465|E3|Reported Event|Hefilcon A|Subjects that received the hefilcon A lens in any of the three study periods.
696177|NCT01882465|E2|Reported Event|2-HEMA, EGDMA Non-ionic|Subjects that received the 2-HEMA, EGDMA Non-ionic lens in any of the three study periods.
696178|NCT01882465|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in any of the three study periods.
696179|NCT01882413|B1|Baseline|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696180|NCT01882413|P1|Participant Flow|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696181|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696182|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696183|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696184|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696185|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696186|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696187|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696188|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696189|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696190|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696191|NCT01882413|O1|Outcome|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696192|NCT01882413|E1|Reported Event|Patients With Planned Cataract Removal|Patients with planned cataract removal surgery are evaluated for the presence of inflammatory dry eye disease. No treatment is administered.
696193|NCT01882257|B4|Baseline|Total|Total of all reporting groups
696338|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696339|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
732885|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
696194|NCT01882257|B3|Baseline|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
696195|NCT01882257|B2|Baseline|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
696196|NCT01882257|B1|Baseline|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
696272|NCT01880840|B2|Baseline|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
696273|NCT01880840|B1|Baseline|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
696274|NCT01880840|P2|Participant Flow|Astepro 0.1%|azelastine hydrochloride 548 mcg nasal spray
696197|NCT01882257|P3|Participant Flow|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
696198|NCT01882257|P2|Participant Flow|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
696199|NCT01882257|P1|Participant Flow|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
696200|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because in determining the efficiency and reliability of home-based overnight testing, there is no difference between the three groups
696201|NCT01882257|O1|Outcome|Entire Tested Population|All groups are considered together because this outcome is simply identifying what portion of the defined population (People with Spinal Cord Injury) have which types of sleep disordered breathing
696202|NCT01882257|E3|Reported Event|BiPAP (AVAPS) for Nocturnal Hypoventilation|"Patients whose home-based sleep study detects nocturnal hypoventilation in the presence or absence of obstructive sleep apnea. Noninvasive ventilatory support will be prescribed according to standard clinical criteria. BiPAP/AVAPS (Phillips Respironics) is worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation.~BiPAP/AVAPS (Phillips Respironics): BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder."
696203|NCT01882257|E2|Reported Event|BiPAP -Auto for Sleep Apnea|"Patients whose home-based sleep study detects obstructive sleep apnea, but no nocturnal hypoventilation. Noninvasive ventilatory support will be prescribed according to standard clinical criteria.~BiPAP: BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea."
696204|NCT01882257|E1|Reported Event|Normal Sleep Breathing|Home-based sleep studies indicate no obstructive sleep apnea or nocturnal hypoventilation. No intervention.
696205|NCT01882062|B1|Baseline|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
696206|NCT01882062|P1|Participant Flow|Triheptanoin Oil at 1g/kg/Day for 1 Month|Patients received triheptanoin oil at 1g/kg/day for 1 month
696207|NCT01882062|O1|Outcome|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
696208|NCT01882062|E1|Reported Event|Triheptanoin Oil at 1g/kg/Day for 1 Month|All the participants received triheptanoin oil at 1g/kg/day for 1 month
696209|NCT01881932|B4|Baseline|Total|Total of all reporting groups
696210|NCT01881932|B3|Baseline|Sham Acupuncture|"Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get sham acupuncture until the end of their chemo while following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will get sham acupuncture until the end of chemo.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. She will tap a mock plastic needle gui"
696231|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
732886|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
696211|NCT01881932|B2|Baseline|Acupuncture|Pts stratified based on cancer (breast cancer vs colorectal cancer). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in past week. Record how much chemo received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get addiinl therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly til the end of chemo. Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to the surface of the same points with adhesive tape, w
696212|NCT01881932|B1|Baseline|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
696213|NCT01881932|P3|Participant Flow|Sham Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). The patients will be randomly assigned to receive sham acupuncture until the end of their chemotherapy while following the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels.~Sham Acupuncture using Park Sham placebo acupuncture device: Participants will receive sham acupuncture until the end of chemotherapy.~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape"
696214|NCT01881932|P2|Participant Flow|Acupuncture|"Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). Patients will be randomly assigned to receive acupuncture until the end of their chemotherapy. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not receive additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points, and"
696215|NCT01881932|P1|Participant Flow|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
696216|NCT01881932|O3|Outcome|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). Patients to get sham acupuncture til the end of their chemo & following the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. Pt complete a wkly questionnaire to determine severity of nerve pain symptoms. Each wk record the total amount of chemo in the past week & all together. Each wk patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device of a retractable needle & an adhesive tube into sham points &apply 2 pieces of adhesive tape next to needles; will tap a mock plastic needle guiding tube on surface of each of 8 true points in the arm & leg to produce some discernible sensation & then apply needle w/ piece of adhesive tape to dermal surface, w/out needle insertion.
696217|NCT01881932|O2|Outcome|Acupuncture|Patients stratified based on cancer (breast cancer vs colorectal cancer). The patients will be randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week & all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication allowed. In standard care arm, patients will not get additional therapy for CIPN. Acupuncture using Seirin® needles: Participants will get acupuncture weekly until the end of chemotherapy. Subjects will get acupuncture at documented acupoints. To improve blinding effect, acupuncturist will also tap 2 guiding tubes at 2 sham points & immediately affix a pair of needles to surface of the same points with adhesive tape, no needle insertion.
696218|NCT01881932|O1|Outcome|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
696232|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696340|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696341|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
696342|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696343|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
696344|NCT01880723|E2|Reported Event|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696219|NCT01881932|E3|Reported Event|Sham Acupuncture|Patients stratified based on cancer (breast vs colorectal). The patients get sham acupuncture til the end of chemo with same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. Patient complete a weekly questionnaire to determine severity of nerve pain symptoms. Weekly record total amount of chemo received in the past week & all together. Each week patient have blood drawn (about 1 tsp) to check nerve growth factors levels. Sham Acupuncture using Park Sham placebo acupuncture device: Particip will get sham acupuncture til the end of chemo. Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle & adhesive tube into the sham points, & then apply 2 pieces of adhesive tape next to needles. Will tap mock plastic needle guiding tube on the surface of each of 8 true points in arm & leg to produce sensation & apply a needle with piece of adhesive tape to dermal surface, no needle insertion.
696220|NCT01881932|E2|Reported Event|Acupuncture|"Patients stratified based on cancer (breast vs colorectal). Patients randomly assigned to get acupuncture until the end of their chemo. Patient will complete a weekly questionnaire to determine severity of nerve pain symptoms. Each week record the total amount of chemo received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 tsp) to check nerve growth factors levels. All patients will follow the same chemo dose reduction algorithm. No concomitant anti-neuropathy medication is allowed. In standard care arm, patients will not get additional therapy for CIPN.~Acupuncture using Seirin® needles: Participants will receive acupuncture weekly until the end of chemotherapy.~Subjects will get acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will tap 2 guiding tubes at 2 sham points & affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion."
696221|NCT01881932|E1|Reported Event|Standard Care|Patients will be stratified based on cancer type (breast cancer vs colorectal cancer). In standard care arm, patients will not receive additional therapy for CIPN. Patient will complete a weekly questionnaire during the study to determine severity of nerve pain symptoms. Each week record the total amount of chemotherapy received in the past week. Record how much chemotherapy received all together. Each week patient will have blood drawn (about 1 teaspoon) to check nerve growth factors levels. All patients will follow the same chemotherapy dose reduction algorithm. No concomitant anti-neuropathy medication is allowed.
696222|NCT01881776|B4|Baseline|Total|Total of all reporting groups
696223|NCT01881776|B3|Baseline|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696275|NCT01880840|P1|Participant Flow|Astepro 0.15%|azelastine hydrochloride 822mcg nasal spray
696276|NCT01880840|O2|Outcome|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
696224|NCT01881776|B2|Baseline|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696225|NCT01881776|B1|Baseline|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696226|NCT01881776|P3|Participant Flow|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696227|NCT01881776|P2|Participant Flow|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696228|NCT01881776|P1|Participant Flow|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696229|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696230|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696345|NCT01880723|E1|Reported Event|Healthy|Healthy control subjects
696346|NCT01880697|B3|Baseline|Total|Total of all reporting groups
696448|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
732887|NCT01681576|O2|Outcome|Valsartan -ALL|Valsartan 320mg QD
696233|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696234|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696235|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696236|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696277|NCT01880840|O1|Outcome|Astepro 0.15% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~205.5 mcg of azelastine hydrochloride: nasal spray"
697474|NCT01873989|E2|Reported Event|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
696237|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696238|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696239|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696240|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696241|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696242|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696243|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696244|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696245|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696246|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696247|NCT01881776|O3|Outcome|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696248|NCT01881776|O2|Outcome|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696249|NCT01881776|O1|Outcome|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696250|NCT01881776|E3|Reported Event|General Anesthesia (GA) Group|Patients in this group received general anesthesia (GA)
696278|NCT01880840|E2|Reported Event|Astepro 0.1% Nasal Spray|"Nasal Spray at a dosage of 1 spray per nostril twice daily~137 mcg of azelastine hydrochloride: nasal spray"
696251|NCT01881776|E2|Reported Event|Continuous ISB (CISB) Group|"Patients in this group received continuous (CISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696252|NCT01881776|E1|Reported Event|Single ISB (SISB) Group|"Patients in this group received single injection (SISB) interscalene brachial plexus block~ISB : In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
696253|NCT01881737|B1|Baseline|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
696254|NCT01881737|P1|Participant Flow|Pregnenolone|Open-Label Trial
696255|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
696256|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
696257|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
696258|NCT01881737|O1|Outcome|Pregnenolone|"Twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg Week 3 and 4: 200 mg Week 5 and 6: 300 mg Week 7 and 8: 400 mg Week 9 -12: 500 mg At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
696347|NCT01880697|B2|Baseline|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696348|NCT01880697|B1|Baseline|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696259|NCT01881737|O1|Outcome|Pregnenolone|"Pregnenolone up to 500 mg per day~Pregnenolone: With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.~Week 1 and 2: 100 mg~Week 3 and 4: 200 mg~Week 5 and 6: 300 mg~Week 7 and 8: 400 mg~Week 9 -12: 500 mg~At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
696260|NCT01881737|O1|Outcome|Pregnenolone|Open-Label study
696261|NCT01881737|E1|Reported Event|Pregnenolone|Pregnenolone was not associated with any severe adverse effects. Single episodes of tiredness (n = 1), diarrhea (n = 1), and depressive affect (n = 1) that could possibly be related to pregnenolone were reported. A few other adverse events with remote chance to be related to the medication were reported: increased excitement/agitation (n = 3), sleep problems (n = 1), drowsiness (n = 1), anorexia/decreased appetite (n = 2), increased motor activity (n = 1), sweating (n = 1), constipation (n = 1), diarrhea (n = 1), tremor (n = 1), and depressive affect (n = 1). No significant vital sign or EKG changes occurred in any study participants. No abnormal laboratory tests were caused by pregnenolone.
696262|NCT01881126|B3|Baseline|Total|Total of all reporting groups
696263|NCT01881126|B2|Baseline|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
696264|NCT01881126|B1|Baseline|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
696265|NCT01881126|P2|Participant Flow|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
696266|NCT01881126|P1|Participant Flow|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
696267|NCT01881126|O2|Outcome|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
696268|NCT01881126|O1|Outcome|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
696269|NCT01881126|E2|Reported Event|Travatan 0.004% and Timolol 0.5%|Travatan 0.004% and timolol 0.5% each administered to both eyes once daily for 12 weeks.
696270|NCT01881126|E1|Reported Event|Bimatoprost 0.01% and Hypromellose 0.3%|Bimatoprost 0.01% and hypromellose 0.3% lubricant eye drops (for masking purposes) each administered to both eyes once daily for 12 weeks.
696281|NCT01880736|B4|Baseline|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
696282|NCT01880736|B3|Baseline|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
696283|NCT01880736|B2|Baseline|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
696284|NCT01880736|B1|Baseline|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
696285|NCT01880736|P4|Participant Flow|IDeg OD Flexible Dosing and Stepwise Titration (Arm D)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the stepwise titration algorithm.
696286|NCT01880736|P3|Participant Flow|IDeg OD Flexible Dosing and Simple Titration (Arm C)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen and the simple titration algorithm.
696287|NCT01880736|P2|Participant Flow|IDeg OD Fixed Dosing and Stepwise Titration (Arm B)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the stepwise titration algorithm.
696288|NCT01880736|P1|Participant Flow|IDeg OD Fixed Dosing and Simple Titration (Arm A)|The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen and the simple titration algorithm.
696289|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696349|NCT01880697|P2|Participant Flow|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696350|NCT01880697|P1|Participant Flow|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696290|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696291|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696292|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696293|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696304|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696294|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696295|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696296|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696297|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696298|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696444|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
696299|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696300|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696301|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696302|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696303|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696359|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696305|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696306|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696307|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696308|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696318|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696309|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696310|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696311|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696312|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696313|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696324|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696314|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696315|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696316|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696317|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696337|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
696319|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696320|NCT01880736|O1|Outcome|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696321|NCT01880736|O4|Outcome|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696322|NCT01880736|O3|Outcome|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696323|NCT01880736|O2|Outcome|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696358|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696325|NCT01880736|E4|Reported Event|IDeg OD Stepwise (Arm B+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed stepwise titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the stepwise titration algorithm. Individual dose was adjusted once weekly and based on the mean of three pre-breakfast SMPG values measured in the morning of titration and the preceding two days. The dose was increased in multiples of 2 units, to a maximum of 8 units, depending on the mean pre-breakfast SMPG value or reduced if symptomatic hypoglycaemia or documented low SMPG values (≤ 3.9 mmol/L/70 mg/dL) occurred. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696326|NCT01880736|E3|Reported Event|IDeg OD Simple (Arm A+Arm C)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who followed simple titration algorithm irrespective of dosing pattern used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks according to the simple titration algorithm. Individual dose was adjusted once weekly was based upon a single pre-breakfast self-measured plasma glucose (SMPG) value measured in the morning of visits 3–27. The dose was either increased by 2 units if pre-breakfast SMPG was above target (4.0–5.0 mmol/L or 71–90 mg/dL) or reduced by 2 units if below target. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696327|NCT01880736|E2|Reported Event|IDeg OD Fixed (Arm A+Arm B)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a fixed dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) OD subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks at the same time each day according to the fixed dosing regimen. A maximum of 3 pre-trial OADs were allowed during the trial at an unchanged, stable dose level and dosing frequency.
696328|NCT01880736|E1|Reported Event|IDeg OD Flexible (Arm C+Arm D)|The trial followed a 2X2 factorial design and therefore the subjects included in this arm are those who received IDeg in a flexible dosing pattern irrespective of titration algorithm used. The subjects received IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) once daily (OD) subcutaneously, under the skin of the thigh, upper arm or abdomen for 26 weeks with the option to vary time of administration within a window of plus/minus 8 hours according to the flexible dosing regimen. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) were allowed during the trial at an unchanged, stable dose level and frequency.
696329|NCT01880723|B3|Baseline|Total|Total of all reporting groups
696330|NCT01880723|B2|Baseline|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696331|NCT01880723|B1|Baseline|Healthy|Healthy Control subjects
696332|NCT01880723|P2|Participant Flow|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696333|NCT01880723|P1|Participant Flow|Healthy|Healthy control subjects
696334|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696335|NCT01880723|O1|Outcome|Healthy|Healthy control subjects
696336|NCT01880723|O2|Outcome|Cystic Fibrosis|Patients diagnosed with cystic fibrosis
696351|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696352|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696353|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696354|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696355|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696356|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696357|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
697475|NCT01873989|E1|Reported Event|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
696360|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696361|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696362|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696363|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696364|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696365|NCT01880697|O2|Outcome|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696366|NCT01880697|O1|Outcome|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696367|NCT01880697|E2|Reported Event|TIVc (≥ 61 Years)|Elderly subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696368|NCT01880697|E1|Reported Event|TIVc (≥18 to ≤ 60 Years)|Adult subjects received one dose of the cell-derived trivalent, surface antigen inactivated subunit influenza virus vaccine (TIVc) formulation 2013/2014 Northern Hemisphere
696369|NCT01880515|B3|Baseline|Total|Total of all reporting groups
696370|NCT01880515|B2|Baseline|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
696371|NCT01880515|B1|Baseline|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
696372|NCT01880515|P2|Participant Flow|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
696373|NCT01880515|P1|Participant Flow|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 (afatinib)"
696374|NCT01880515|O2|Outcome|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
696375|NCT01880515|O1|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 whereas the non-intervention group will recieve general dermatological recomendations while on treatment with BIBW2992."
696376|NCT01880515|O2|Outcome|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
696377|NCT01880515|O1|Outcome|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
696378|NCT01880515|E2|Reported Event|No Tetracycline|This arm only with general dermatologic recommendations. Patients in this arm can receive tetracycline after week 4 of assessment only if rash grade 3-4 occur
696379|NCT01880515|E1|Reported Event|Tetracycline|"Patients will receive tetracycline 250mg every 12 hours for 1 month plus general dermatological recommendations (sunscreen and emollient cream)~Tetracycline: The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW 2992"
696380|NCT01880437|B4|Baseline|Total|Total of all reporting groups
696381|NCT01880437|B3|Baseline|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696382|NCT01880437|B2|Baseline|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696383|NCT01880437|B1|Baseline|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696384|NCT01880437|P3|Participant Flow|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696385|NCT01880437|P2|Participant Flow|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696529|NCT01879722|P3|Participant Flow|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696386|NCT01880437|P1|Participant Flow|Poor Risk Cytogenetics|Participants with relapsed/refractory acute myeloid leukemia (AML) or relapsed/refractory high-risk myelodysplastic syndrome (MDS) falling under 'poor risk cytogenetics' subgroup received oral 150 milligrams (mg) dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696387|NCT01880437|O1|Outcome|Planned Cohort 2|Participants in Cohort 2 were planned to receive low-dose subcutaneous injections of cytarabine in combination with continuous daily vismodegib (150 mg orally).
696388|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696389|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696390|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696391|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696392|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696393|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696394|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696395|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696396|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696397|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696398|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696399|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696445|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
696446|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
696447|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
696400|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696401|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696402|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696403|NCT01880437|O3|Outcome|Neither Poor Risk Cytogenetics Nor FLT3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696404|NCT01880437|O2|Outcome|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696405|NCT01880437|O1|Outcome|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696406|NCT01880437|E3|Reported Event|Neither Poor Risk Cytogenetics Nor FLT-3|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling neither under 'poor risk cytogenetics' nor 'FLT-3 mutation positive' subgroup were included in this group and received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696407|NCT01880437|E2|Reported Event|FLT-3 Mutation Positive|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'FLT-3 mutation positive' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696408|NCT01880437|E1|Reported Event|Poor Risk Cytogenetics|Participants with relapsed/refractory AML or relapsed/refractory high-risk MDS falling under 'poor risk cytogenetics' subgroup received oral 150 mg dose of vismodegib capsule once daily until disease progression, intolerable toxicity most probably attributable to vismodegib, or participant withdrawal of consent.
696409|NCT01880424|B3|Baseline|Total|Total of all reporting groups
696410|NCT01880424|B2|Baseline|Placebo Arm|matching placebo capsules, oral, once daily
696411|NCT01880424|B1|Baseline|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696412|NCT01880424|P2|Participant Flow|Placebo Arm|matching placebo capsules, oral, once daily
696413|NCT01880424|P1|Participant Flow|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696414|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696415|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696416|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696417|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696418|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696419|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696420|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696421|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696422|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696423|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696424|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696425|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696426|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696427|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696428|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696429|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696430|NCT01880424|O2|Outcome|Placebo Arm|matching placebo capsules, oral, once daily
696431|NCT01880424|O1|Outcome|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696432|NCT01880424|E2|Reported Event|Placebo Arm|matching placebo capsules, oral, once daily
696433|NCT01880424|E1|Reported Event|Linaclotide Arm|Linaclotide 290 ug capsules, oral, once daily
696434|NCT01880320|B4|Baseline|Total|Total of all reporting groups
696435|NCT01880320|B3|Baseline|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
696436|NCT01880320|B2|Baseline|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
696437|NCT01880320|B1|Baseline|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
696438|NCT01880320|P3|Participant Flow|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
696439|NCT01880320|P2|Participant Flow|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
696440|NCT01880320|P1|Participant Flow|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
696441|NCT01880320|O3|Outcome|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
696442|NCT01880320|O2|Outcome|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
696443|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
696449|NCT01880320|O1|Outcome|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
696450|NCT01880320|E3|Reported Event|Topical Gel Vehicle|"Placebo arm~Topical Gel Vehicle"
696451|NCT01880320|E2|Reported Event|CD0271 0.1% / CD1579 2.5%|"Comparator arm~CD0271 0.1% / CD1579 2.5%"
696452|NCT01880320|E1|Reported Event|CD0271 0.3% /CD1579 2.5% Gel|"Active arm~CD0271 0.3% / CD1579 2.5%"
696453|NCT01880086|B3|Baseline|Total|Total of all reporting groups
696454|NCT01880086|B2|Baseline|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696455|NCT01880086|B1|Baseline|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696456|NCT01880086|P2|Participant Flow|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696457|NCT01880086|P1|Participant Flow|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696458|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696459|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696460|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696461|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696462|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696463|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696464|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696465|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696466|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696467|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
732888|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg QD
696468|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696469|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696470|NCT01880086|O2|Outcome|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696535|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696471|NCT01880086|O1|Outcome|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696472|NCT01880086|E2|Reported Event|Placebo|"Placebo pill will be administered (po, pill by mouth) every other day starting at week 0 of the study in men diagnosed with low testosterone. Treatment will be delayed in these men until the 3 month completion of the study, at which time this group may also receive testosterone replacement therapy.~Placebo: Placebo pill that will have appearance identical to the treatment pill but will not contain active medication."
696473|NCT01880086|E1|Reported Event|Clomiphene Citrate|"The initial dose of clomiphene citrate will be 25 mg (po, pill by mouth) every other day. This will be started at visit 2, week 0 of the study following diagnosis of low baseline testosterone (serum total testosterone <350 ng/dl in men <55 years, <300 ng/dl in men 55-65 years). Clomiphene citrate dose will be titrated up to a maximum of 50 mg daily according to serum total testosterone levels measured at follow-up visits during the 3 month duration of the study.~Clomiphene citrate"
696474|NCT01879852|B3|Baseline|Total|Total of all reporting groups
696475|NCT01879852|B2|Baseline|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696476|NCT01879852|B1|Baseline|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696477|NCT01879852|P2|Participant Flow|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696478|NCT01879852|P1|Participant Flow|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696479|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696480|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696515|NCT01879722|B7|Baseline|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696516|NCT01879722|B6|Baseline|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696517|NCT01879722|B5|Baseline|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
697164|NCT01876706|E1|Reported Event|UroLift Arm|Subjects that undergo the UroLift System procedure
696481|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696482|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696483|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696530|NCT01879722|P2|Participant Flow|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
700961|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg IVT injection
696484|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696485|NCT01879852|O2|Outcome|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696486|NCT01879852|O1|Outcome|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696487|NCT01879852|E2|Reported Event|Standard Rehabilitation + Quadriceps Intensive Strengthening|"The intervention includes high-intensity neuromuscular electrical stimulation and eccentric exercises for the quadriceps muscle in addition to the standard rehabilitation protocol.~Quadriceps intensive strengthening: Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696488|NCT01879852|E1|Reported Event|Standard Rehabilitation|"Standard meniscectomy rehabilitation including knee range of motion and strengthening exercises.~Standard rehabilitation: Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)"
696489|NCT01879800|B3|Baseline|Total|Total of all reporting groups
696490|NCT01879800|B2|Baseline|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
696491|NCT01879800|B1|Baseline|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
696492|NCT01879800|P2|Participant Flow|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
696493|NCT01879800|P1|Participant Flow|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
696518|NCT01879722|B4|Baseline|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
697165|NCT01876368|B3|Baseline|Total|Total of all reporting groups
696494|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
696495|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
696496|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
696497|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
696531|NCT01879722|P1|Participant Flow|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696532|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696533|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696498|NCT01879800|O2|Outcome|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
696499|NCT01879800|O1|Outcome|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
696500|NCT01879800|E2|Reported Event|Acceptance and Commitment Therapy Plus Illness Management|"Acceptance and Commitment Training plus Illness Management (ACT-IM) Patients in the ACT-IM group will attend a 1-day group workshop. Three broad areas will be covered: 1) Illness Management will cover the importance of physical and psychological self-care for the management of co-morbid depression/anxiety and vascular problems 2) Behavioral Change Training will involve i) teaching patients how to recognize ineffective patterns of behavior and habits, ii) exploring and setting life goals and those related to mental and physical health, and iii) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 3) Mindfulness and Acceptance Training will emphasize new ways of managing troubling thoughts, feelings, and physical sensations .~Acceptance and Commitment Therapy plus Illness Management"
696501|NCT01879800|E1|Reported Event|Treatment As Usual/Waitlist|Treatment As Usual/Waitlist
696502|NCT01879735|B3|Baseline|Total|Total of all reporting groups
696503|NCT01879735|B2|Baseline|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
696504|NCT01879735|B1|Baseline|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the rate constants for the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
696505|NCT01879735|P2|Participant Flow|Bolus and Constant Infusion of 11C-CSar|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
696506|NCT01879735|P1|Participant Flow|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
696507|NCT01879735|O2|Outcome|Infusion Method|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
696508|NCT01879735|O1|Outcome|ICG Infusion|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
696509|NCT01879735|E2|Reported Event|Bolus vs. Constant Infusion|Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion.
696510|NCT01879735|E1|Reported Event|ICG's Effect on 11C-CSar Transport|Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG.
696511|NCT01879722|B11|Baseline|Total|Total of all reporting groups
696512|NCT01879722|B10|Baseline|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
696513|NCT01879722|B9|Baseline|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696514|NCT01879722|B8|Baseline|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
697260|NCT01875731|B3|Baseline|Total|Total of all reporting groups
696519|NCT01879722|B3|Baseline|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696520|NCT01879722|B2|Baseline|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696521|NCT01879722|B1|Baseline|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia
696522|NCT01879722|P10|Participant Flow|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
696523|NCT01879722|P9|Participant Flow|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696524|NCT01879722|P8|Participant Flow|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696525|NCT01879722|P7|Participant Flow|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696526|NCT01879722|P6|Participant Flow|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696527|NCT01879722|P5|Participant Flow|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696528|NCT01879722|P4|Participant Flow|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696536|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696537|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696538|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696539|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696540|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696541|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696542|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696543|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696544|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696545|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696546|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696547|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696548|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696549|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696550|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696551|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696552|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696553|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696554|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696555|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696556|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696557|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696558|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696559|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696560|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696561|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696562|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696563|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696564|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696565|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696566|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696567|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696568|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696569|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696570|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696571|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696572|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696573|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696574|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696575|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696576|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696577|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696578|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
697562|NCT01872611|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
696579|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696580|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696581|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696582|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696583|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696584|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696585|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696586|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696587|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696588|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696589|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696590|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696591|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696592|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696593|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696594|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696595|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696596|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696597|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696598|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696599|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696600|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696601|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696602|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696603|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696604|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696605|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696606|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696607|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696608|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696609|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696610|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696611|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696612|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696613|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696614|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696615|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696616|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696617|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696618|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696619|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696620|NCT01879722|O8|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696621|NCT01879722|O7|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696622|NCT01879722|O6|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696623|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696624|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696625|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696626|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696627|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696628|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
696629|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696630|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696631|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696632|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696633|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696634|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696635|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696636|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696637|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696638|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
696639|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696640|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696641|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696642|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696643|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696644|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696645|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696646|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696647|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696648|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
696649|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696650|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696651|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696652|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696653|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696654|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
697451|NCT01874132|E3|Reported Event|Control|Non-exercising control group
696655|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696656|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696657|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696658|NCT01879722|O10|Outcome|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
696659|NCT01879722|O9|Outcome|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696660|NCT01879722|O8|Outcome|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696661|NCT01879722|O7|Outcome|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696662|NCT01879722|O6|Outcome|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696663|NCT01879722|O5|Outcome|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696664|NCT01879722|O4|Outcome|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696665|NCT01879722|O3|Outcome|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696666|NCT01879722|O2|Outcome|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696667|NCT01879722|O1|Outcome|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696668|NCT01879722|E10|Reported Event|Placebo (Healthy Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in healthy Japanese participants.
696669|NCT01879722|E9|Reported Event|TAK-063 20 mg (Healthy Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696670|NCT01879722|E8|Reported Event|TAK-063 10 mg (Healthy Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696671|NCT01879722|E7|Reported Event|TAK-063 3 mg (Healthy Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in healthy Japanese participants.
696672|NCT01879722|E6|Reported Event|Placebo (Schizophrenia Participants)|Placebo matching TAK-063, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696673|NCT01879722|E5|Reported Event|TAK-063 100 mg (Schizophrenia Participants)|TAK-063 100 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696674|NCT01879722|E4|Reported Event|TAK-063 30 mg (Schizophrenia Participants)|TAK-063 30 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696675|NCT01879722|E3|Reported Event|TAK-063 20 mg (Schizophrenia Participants)|TAK-063 20 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696676|NCT01879722|E2|Reported Event|TAK-063 10 mg (Schizophrenia Participants)|TAK-063 10 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696677|NCT01879722|E1|Reported Event|TAK-063 3 mg (Schizophrenia Participants)|TAK-063 3 mg, tablets, orally, once daily for 7 days in participants with Schizophrenia.
696678|NCT01879683|B1|Baseline|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
696679|NCT01879683|P1|Participant Flow|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
696680|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
696681|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
696682|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
696683|NCT01879683|O1|Outcome|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
696684|NCT01879683|E1|Reported Event|LiRIS® 400 mg|LiRIS® 400 mg (Lidocaine Releasing Intravesical System 400 mg); a drug-device combination product, placed in the urinary bladder, and releases lidocaine into the bladder over a 14 day period.
696685|NCT01879618|B1|Baseline|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
696686|NCT01879618|P1|Participant Flow|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
696687|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
696688|NCT01879618|O1|Outcome|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
696847|NCT01879059|E1|Reported Event|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
696689|NCT01879618|E1|Reported Event|FRAGMIN|Participants were initially administered standard FRAGMIN dose of 5000 IU into the arterial side of the dialyzer and were permitted dose adjustments by increments/decrements of 500 or 1000 IU, for subsequent HD sessions depending upon the outcome of previous HD session and any intervening clinical events since previous HD session.
696690|NCT01879579|B3|Baseline|Total|Total of all reporting groups
696691|NCT01879579|B2|Baseline|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696692|NCT01879579|B1|Baseline|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696693|NCT01879579|P2|Participant Flow|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696735|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
697184|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
696694|NCT01879579|P1|Participant Flow|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696695|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
696696|NCT01879579|O1|Outcome|All Participants|Participants in both study arms (MITI and CBP).
696697|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696698|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696699|NCT01879579|O2|Outcome|Insulin Titration Visits in the Clinic|Insulin titration visits that occurred in the clinic in both study arms (MITI and CBP arms).
696700|NCT01879579|O1|Outcome|Insulin Titration Visits by Phone|Insulin titration visits that occurred over the phone in both study arms (MITI and CBP arms).
696701|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696702|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696703|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696704|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696705|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696706|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696848|NCT01878825|B3|Baseline|Total|Total of all reporting groups
697510|NCT01873729|B1|Baseline|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
696707|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696708|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696709|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696710|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696711|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696975|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696712|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696713|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696714|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696715|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696716|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696717|NCT01879579|O2|Outcome|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696718|NCT01879579|O1|Outcome|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696719|NCT01879579|E2|Reported Event|Current Best Practice|Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
696720|NCT01879579|E1|Reported Event|Mobile Insulin Titration Intervention|"Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.~Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration."
696721|NCT01879553|B3|Baseline|Total|Total of all reporting groups
696722|NCT01879553|B2|Baseline|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696723|NCT01879553|B1|Baseline|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696724|NCT01879553|P2|Participant Flow|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696725|NCT01879553|P1|Participant Flow|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696726|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696727|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696728|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696729|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696730|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696731|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696732|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696733|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696734|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696736|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696737|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696738|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696739|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696740|NCT01879553|O2|Outcome|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696741|NCT01879553|O1|Outcome|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696742|NCT01879553|E3|Reported Event|Total|Total
696743|NCT01879553|E2|Reported Event|TIV (≥ 61 Years)|Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696744|NCT01879553|E1|Reported Event|TIV (18 to ≤ 60 Years)|Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
696745|NCT01879540|B1|Baseline|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696746|NCT01879540|P1|Participant Flow|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696747|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696748|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696749|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696750|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696751|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696752|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696753|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696754|NCT01879540|O1|Outcome|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696755|NCT01879540|E1|Reported Event|aTIV|Adult subjects ≥65 years of age received one dose of a trivalent, surface antigen, inactivated influenza vaccine including MF59C.1 adjuvant (aTIV), formulation 2013/2014 Northern Hemisphere
696756|NCT01879410|B3|Baseline|Total|Total of all reporting groups
696757|NCT01879410|B2|Baseline|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
696758|NCT01879410|B1|Baseline|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
696759|NCT01879410|P2|Participant Flow|FSC 250/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 250/50 µg twice daily (BID) in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
696760|NCT01879410|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg)) once daily (QD) in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI for 12 weeks.
696761|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
696762|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
696763|NCT01879410|O2|Outcome|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
696764|NCT01879410|O1|Outcome|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
696765|NCT01879410|E2|Reported Event|FSC 250/50 mcg|Participants received FSC 250/50 µg BID in the morning and evening via a DPI and placebo in the morning via a separate DPI for 12 weeks.
696766|NCT01879410|E1|Reported Event|UMEC/VI 62.5/25 mcg|Participants received UMEC/VI 62.5/25 µg QD in the morning via a DPI and placebo in the morning and evening via a separate DPI for 12 weeks.
696767|NCT01879371|B7|Baseline|Total|Total of all reporting groups
696783|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696784|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696768|NCT01879371|B6|Baseline|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696769|NCT01879371|B5|Baseline|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696770|NCT01879371|B4|Baseline|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696771|NCT01879371|B3|Baseline|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696772|NCT01879371|B2|Baseline|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696773|NCT01879371|B1|Baseline|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696774|NCT01879371|P6|Participant Flow|Ibu Lysinate / Ibu Acid / Ibu + Caf|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696775|NCT01879371|P5|Participant Flow|Ibu Lysinate/ Ibu + Caf / Ibu Acid|Participants first received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696776|NCT01879371|P4|Participant Flow|Ibu Acid/ Ibu + Caf / Ibu Lysinate|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696933|NCT01878656|B3|Baseline|Total|Total of all reporting groups
696777|NCT01879371|P3|Participant Flow|Ibu Acid / Ibu Lysinate/ Ibu + Caf|Participants first received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696778|NCT01879371|P2|Participant Flow|Ibu + Caf / Ibu Lysinate / Ibu Acid|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696779|NCT01879371|P1|Participant Flow|Ibu + Caf / Ibu Acid / Ibu Lysinate|Participants first received Treatment T (400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet). After a washout phase of at least 6 days, they then received Treatment R1 (400mg Ibuprofen acid (Brufen®) film-coated tablet). After a washout phase of at least 6 days, they then received Treatment R2 (400mg Ibuprofen lysinate (Nurofen® immedia) film-coated tablet). Every treatment is given oral as single dose of one tablet with 240 mL of water after an overnight fast of at least 10 h.
696780|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696781|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696782|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696785|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696786|NCT01879371|O3|Outcome|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696787|NCT01879371|O2|Outcome|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696788|NCT01879371|O1|Outcome|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696789|NCT01879371|E3|Reported Event|Ibuprofen Lysinate Film-coated Tablet|Ibuprofen lysinate (Nurofen® immedia) film-coated tablet; 400 mg Ibuprofen; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696790|NCT01879371|E2|Reported Event|Ibuprofen Acid Film-coated Tablet|400 mg Ibuprofen acid (Brufen®) film-coated tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696791|NCT01879371|E1|Reported Event|Ibuprofen + Caffeine (FDC) Tablet|400 mg Ibuprofen + 100 mg Caffeine fixed dose combination (FDC) tablet; Single dose oral administration of one tablet with 240 mL of water after an overnight fast of at least 10h
696792|NCT01879345|B4|Baseline|Total|Total of all reporting groups
696793|NCT01879345|B3|Baseline|Placebo|PLC, Placebo
696794|NCT01879345|B2|Baseline|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
696795|NCT01879345|B1|Baseline|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
696796|NCT01879345|P3|Participant Flow|Placebo|PLC, Placebo
696797|NCT01879345|P2|Participant Flow|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
696798|NCT01879345|P1|Participant Flow|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
696799|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
696800|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
696801|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
696802|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
696803|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|4 tablets of BIA 2-093 600 mg BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg Oxcarbazepine is a BIA 2-093 metabolite
696804|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|3 tablets of BIA 2-093 600 mg BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093 Oxcarbazepine is a BIA 2-093 metabolite
696805|NCT01879345|O3|Outcome|Placebo|PLC, Placebo
696806|NCT01879345|O2|Outcome|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
696807|NCT01879345|O1|Outcome|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
696808|NCT01879345|E3|Reported Event|Placebo|PLC, Placebo
696809|NCT01879345|E2|Reported Event|BIA 2-093 - 2400 mg (Group 2)|"4 tablets of BIA 2-093 600 mg~BIA 2-093 - 2400 mg (Group 2): 4 tablets of BIA 2-093 600 mg"
696810|NCT01879345|E1|Reported Event|BIA 2-093 - 1800 mg (Group 1)|"3 tablets of BIA 2-093 600 mg~BIA 2-093 - 1800 mg (Group 1): 3 tablets of BIA 2-093"
696811|NCT01879332|B4|Baseline|Total|Total of all reporting groups
696812|NCT01879332|B3|Baseline|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
697028|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697029|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
696813|NCT01879332|B2|Baseline|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
696814|NCT01879332|B1|Baseline|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
696815|NCT01879332|P3|Participant Flow|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
696816|NCT01879332|P2|Participant Flow|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
696817|NCT01879332|P1|Participant Flow|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
696818|NCT01879332|O3|Outcome|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
696819|NCT01879332|O2|Outcome|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
696820|NCT01879332|O1|Outcome|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
696821|NCT01879332|E3|Reported Event|Placebo|"Matching placebo tablets for oral administration~Placebo: Matching placebo tablets for oral administration"
696822|NCT01879332|E2|Reported Event|BIA 2-093 3600 mg Once Daily|"Subjects in Cohort 1 received a dose of 3600 mg once daily (6 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3600 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
696823|NCT01879332|E1|Reported Event|BIA 2-093 3000 mg Once Daily|"Subjects in Cohort 2 received a dose of 3000 mg once daily (5 x 600 mg eslicarbazepine acetate tablets)~BIA 2-093 3000 mg once daily: Eslicarbazepine acetate 600 mg tablets for oral administration"
696824|NCT01879319|B3|Baseline|Total|Total of all reporting groups
696825|NCT01879319|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
696826|NCT01879319|B1|Baseline|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
696827|NCT01879319|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
696828|NCT01879319|P1|Participant Flow|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 4 and 8.
696829|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
696830|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
696831|NCT01879319|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
696832|NCT01879319|O1|Outcome|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
696833|NCT01879319|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 420 mg once a month subcutaneously using an autoinjector/pen (AI/pen) (three 1.0 mL injections) for 8 weeks (Day 1, Week 4, and Week 8).
696834|NCT01879319|E1|Reported Event|Evolocumab AMD|Participants received evolocumab 420 mg once a month subcutaneously using an automated mini-doser (AMD) (one 3.5 mL injection) for 8 weeks (Day 1, Week 4, and Week 8).
696835|NCT01879176|B3|Baseline|Total|Total of all reporting groups
696836|NCT01879176|B2|Baseline|Control|No filter will be installed on the CPB machine.
696837|NCT01879176|B1|Baseline|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1.
696838|NCT01879176|P2|Participant Flow|Control|No filter will be installed on the CPB machine.
696839|NCT01879176|P1|Participant Flow|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
696840|NCT01879176|O2|Outcome|Control|No filter will be installed on the CPB machine.
696841|NCT01879176|O1|Outcome|CytoSorb|For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .
696842|NCT01879176|E2|Reported Event|Control|No filter will be installed on the CPB machine.
696843|NCT01879176|E1|Reported Event|CytoSorb|"For the intervention group, the CytoSorb filter will be installed on the CPB machine in a parallel circuit to the body circulation. The flow through the filter will be driven by a roller pump with 200ml.min-1 .~CytoSorb"
696844|NCT01879059|B1|Baseline|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
696845|NCT01879059|P1|Participant Flow|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
696846|NCT01879059|O1|Outcome|Exercise|"5 days of inactivity followed by a 1 day return to physical activity~Exercise: short period of inactivity (5 days) followed by a return to physical activity (1 day)"
696849|NCT01878825|B2|Baseline|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696850|NCT01878825|B1|Baseline|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
696851|NCT01878825|P2|Participant Flow|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696852|NCT01878825|P1|Participant Flow|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
696853|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696854|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696855|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696856|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696857|NCT01878825|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696976|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696858|NCT01878825|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696859|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696860|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696861|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696862|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696863|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696864|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696865|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696866|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696867|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696868|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696869|NCT01878825|O4|Outcome|Fluviral >60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696870|NCT01878825|O3|Outcome|Fluviral > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696871|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696872|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696873|NCT01878825|O4|Outcome|Fluviral > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696874|NCT01878825|O3|Outcome|Fluviral >60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696875|NCT01878825|O2|Outcome|Fluviral 18-60 Years Group Without Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had not received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696876|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group With Vaccination|Subjects 18-60 years of age received 1 dose of Fluviral™ 2013-2014 vaccine at Day 0 and who had received an influenza vaccine during the 2012-2013 influenza season. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
696877|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696878|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
696879|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696880|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
696881|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696914|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696882|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
696883|NCT01878825|O2|Outcome|Fluviral >60 Years Group|Subjects aged > 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696884|NCT01878825|O1|Outcome|Fluviral 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
696885|NCT01878825|E2|Reported Event|Fluarix/Influsplit › 60 Years Group|Subjects aged › 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
696886|NCT01878825|E1|Reported Event|Fluarix/Influsplit 18-60 Years Group|Subjects aged between 18 and 60 years, received 1 dose of Fluviral™ vaccine on Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
696887|NCT01878812|B3|Baseline|Total|Total of all reporting groups
696888|NCT01878812|B2|Baseline|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696889|NCT01878812|B1|Baseline|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696890|NCT01878812|P2|Participant Flow|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696891|NCT01878812|P1|Participant Flow|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696892|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696893|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696894|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696895|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696896|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696897|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696898|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696899|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696900|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696901|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696902|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696903|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696904|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696905|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696906|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696907|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696908|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696909|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696910|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696911|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696912|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696913|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696974|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696915|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696916|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696917|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696918|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696919|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696920|NCT01878812|O2|Outcome|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696921|NCT01878812|O1|Outcome|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696922|NCT01878812|E2|Reported Event|Fluarix/Influsplit Tetra® Elderly Group|Subjects >60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696923|NCT01878812|E1|Reported Event|Fluarix/Influsplit Tetra® Adult Group|Subjects 18-60 years of age receiving Fluarix/Influsplit Tetra® 2013-2014, administered intramuscularly in the deltoid region of the non-dominant arm.
696924|NCT01878799|B3|Baseline|Total|Total of all reporting groups
696925|NCT01878799|B2|Baseline|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696926|NCT01878799|B1|Baseline|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696927|NCT01878799|P2|Participant Flow|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696928|NCT01878799|P1|Participant Flow|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696929|NCT01878799|O2|Outcome|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696930|NCT01878799|O1|Outcome|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696931|NCT01878799|E2|Reported Event|Subjects With HIV and HCV Who Are Not on Antiretroviral Agents|Subjects with HIV and HCV who are not on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696932|NCT01878799|E1|Reported Event|Subjects With HIV and HCV on Antiretroviral Agents|Subjects with HIV and HCV on antiretroviral agents given 'Drug: GS-7977 (sofosbuvir 400mg)/GS-5885 (ledipasvir 90mg) FDC' once daily by mouth for 12 weeks. The GS-7977/GS-5885 product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor.
696934|NCT01878656|B2|Baseline|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
696935|NCT01878656|B1|Baseline|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
696936|NCT01878656|P2|Participant Flow|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
696937|NCT01878656|P1|Participant Flow|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
696938|NCT01878656|O2|Outcome|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
697271|NCT01875510|B3|Baseline|Total|Total of all reporting groups
696939|NCT01878656|O1|Outcome|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
696940|NCT01878656|E2|Reported Event|Desflurane|"administration of desflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Desflurane: The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued."
696941|NCT01878656|E1|Reported Event|Sevoflurane|"administration of sevoflurane with oxygen and nitrous oxide as same ratio of 3 L/min for maintenance of general anesthesia~Sevoflurane: The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued."
696942|NCT01878604|B1|Baseline|Patients of HoFH|patients of Homozygous Familial Hypercholesterolemia
696943|NCT01878604|P1|Participant Flow|Homozygous Familial Hypercholesterolemia|"Gene Analysis for Homozygous Familial Hypercholesterolemia cases~Gene analysis: Gene analysis"
696944|NCT01878604|O1|Outcome|HoFH Patients|"patients of Homozygous Familial Hypercholesterolemia that meet the Inclusion criteria:~Cutaneous xanthomata before the age of ten years~LDLC > 13 mmol/L before treatment or > 7.76 mmol/L despite treatment~Phenotypic features in keeping with HeFH in both parents"
696945|NCT01878604|O1|Outcome|HoFH Patients|HoFH patients
696946|NCT01878604|E1|Reported Event|HoFH Patients|all HoFH patients enrolled in this study
696947|NCT01878526|B3|Baseline|Total|Total of all reporting groups
696948|NCT01878526|B2|Baseline|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
696949|NCT01878526|B1|Baseline|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
696950|NCT01878526|P2|Participant Flow|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
696951|NCT01878526|P1|Participant Flow|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
696952|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
696953|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
696954|NCT01878526|O1|Outcome|Overall Systemic Sclerosis With GERD (Before Randomization)|omeprazole 20 mg bid ac for 4 weeks for overall systemic sclerosis with GERD
696955|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
696956|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
696957|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
696958|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
696959|NCT01878526|O2|Outcome|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
697030|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697031|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
696960|NCT01878526|O1|Outcome|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
696961|NCT01878526|E2|Reported Event|Omeprazole Plus Domperidone and Placebo of Alginic Acid|"Domperidone: domperidone (10 mg) 1 tab oral tid before meal~placebo (of alginic acid): placebo (for alginic acid) 1 tab chew tid after meal"
696962|NCT01878526|E1|Reported Event|Omeprazole Plus Alginic Acid and Placebo of Domperidone|"Alginic acid: Algycon 1 tab chew tid after meal~placebo (for domperidone): placebo (for domperidone) 1 tab oral tid before meal"
696963|NCT01878214|B3|Baseline|Total|Total of all reporting groups
696964|NCT01878214|B2|Baseline|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696965|NCT01878214|B1|Baseline|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696966|NCT01878214|P2|Participant Flow|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696967|NCT01878214|P1|Participant Flow|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696968|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696969|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696970|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696971|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696972|NCT01878214|O2|Outcome|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696973|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696977|NCT01878214|O1|Outcome|Intervention Group|"Targeted messaging~Targeted messaging: 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696978|NCT01878214|E2|Reported Event|Control Group|"Standard messaging~Standard messaging: 1 informational letter"
696979|NCT01878214|E1|Reported Event|Intervention Group|"Targeted messaging~Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages~Standard messaging: 1 informational letter"
696980|NCT01878175|B1|Baseline|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696981|NCT01878175|P1|Participant Flow|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at VA medical center, in-home with clinical personnel, and via telephone. Intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program focuses on lower extremity mobility, muscle stability and functional movement patterns. Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week.
696982|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696983|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696984|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696985|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
697032|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697033|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697034|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697035|NCT01877720|E2|Reported Event|NIV-PS|non-invasive PS
696986|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696987|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696988|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
697046|NCT01877408|P1|Participant Flow|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697047|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697563|NCT01872611|E3|Reported Event|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
696989|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696990|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696991|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696992|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696993|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696994|NCT01878175|O1|Outcome|Functional Movement Retraining|Functional Movement Retraining: 15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
697036|NCT01877720|E1|Reported Event|NIV-NAVA|non-invasive NAVA
697127|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil 600 mg (one capsule twice daily) for two weeks during the 1st phase of the study or during the second phase after the washout period.
697511|NCT01873729|P1|Participant Flow|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
696995|NCT01878175|O1|Outcome|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696996|NCT01878175|E1|Reported Event|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
696997|NCT01878149|B3|Baseline|Total|Total of all reporting groups
696998|NCT01878149|B2|Baseline|eXtreme Lumbar Interbody Fusion (XLIF®)|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the XLIF® spinal procedure. XLIF® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
696999|NCT01878149|B1|Baseline|VEO® Lateral Access and Interbody Fusion System|This study included adult men and women (> 18 years old) who received a lateral lumbar interbody fusion (LLIF) with the VEO® spinal procedure. VEO® is intended to treat patients with conditions who typically require fusion at the lumbar levels for degenerative disc disease (DDD).
697000|NCT01878149|P2|Participant Flow|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc.When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
697001|NCT01878149|P1|Participant Flow|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the Baxano Surgical LLIF system, which employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. The VEO® system was developed with an initial, radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. Dissection through the psoas is then performed with direct vision in conjunction with EMG. The psoas muscle is split anterior-posterior along muscle fiber lines and the retraction is performed with two independent blades. Insertion depth may be varied to avoid muscle creep, and the toed-out blade tips are positioned under the psoas to hold the system in place. An inner sleeve is inserted to lock the blades in place at the desired radial tension for a customizable disc space exposure. Standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
697002|NCT01878149|O2|Outcome|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
697003|NCT01878149|O1|Outcome|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
697004|NCT01878149|E2|Reported Event|eXtreme Lumbar Interbody Fusion (XLIF®)|The eXtreme lumbar interbody fusion (XLIF®) is the brand name of the LLIF system distributed by NuVasive®, Inc. in 2001. When the XLIF® system is used for LLIF, the patient is placed in the lateral decubitus position and the retroperitoneal space is accessed through blunt dissection. Using proprietary neuromonitoring, a series of graduated muscle dilators are advanced through the psoas muscle down to the disc space at the lumbar level of interest. Real-time EMG evoked potential values indicate proximity of motor nerves to direct safe dilator placement. A guidewire is placed into the disc space through the initial cannulated dilator to fix retractor placement. A psoas muscle retractor system is inserted over the dilators and the blades are carefully opened over the disc space in the caudal-cephalad and anterior directions under direct live EMG. Upon achieving sufficient disc space exposure, standard discectomy, endplate preparation, cage implantation, and wound closure are performed.
697037|NCT01877538|B1|Baseline|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical used with Positron Emission Tomography (PET) imaging. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were recruited to this study."
697005|NCT01878149|E1|Reported Event|VEO® Lateral Access and Interbody Fusion System|VEO® is the brand name for the LLIF system introduced by Baxano Surgical® in 2011. The VEO® Lateral system employs traditional LLIF patient positioning, disc space preparation, implant placement, and is compatible with neuromonitoring. However, the VEO® system posesses a radiolucent retractor that is placed at the psoas fascia and held in place with an articulated arm. This retractor was developed to address the reliance on EMG neuromonitoring alone with traditional LLIF approaches to avoid injury to lumbar plexus nerve roots, particularly as EMG is limited to monitoring motor nerves. Moreover, there was a desire to avoid reliance on fluoroscopy alone to determine retractor placement, without significant assessment of intervening anatomy.
697006|NCT01877941|B1|Baseline|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
697007|NCT01877941|P1|Participant Flow|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
697008|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest."
697048|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697049|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697009|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.~Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
697010|NCT01877941|O1|Outcome|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored by pulmonary artery catheter (PAC) and endotracheal cardiac output monitoring (ECOM) during surgery and during post-surgical recovery, will also have sensors placed on the arm, finger and leg to calculate pulse wave transit time (PWTT) using the estimated Continuous Cardiac Output system (ecCCO).~Pulmonary Artery Catheter (PAC): A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.~Endotracheal Cardiac Output Monitor (ECOM): An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.~Estimated Continuous Cardiac Output (esCCO): Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body."
697011|NCT01877941|E1|Reported Event|Cardiac Output Monitoring|"Patients undergoing surgery who will have their cardiac output monitored during surgery and during post-surgical recovery. For instance, patients with ischemic heart disease undergoing cardiac bypass graft or percutaneous coronary intervention.~No adverse events."
697012|NCT01877720|B1|Baseline|Total Enrolled Patients|
697013|NCT01877720|P2|Participant Flow|NAVA-PS|"noninvasive NAVA first for 15 minutes and then PSV for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
697014|NCT01877720|P1|Participant Flow|PS-NAVA|"noninvasive PSV first for 15 minutes and then NAVA for 15 minutes~crossover of noninvasive respiratory support with NAVA mode and PSV"
697015|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697016|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697017|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697018|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697019|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697020|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697021|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697022|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697023|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697024|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697025|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697026|NCT01877720|O1|Outcome|NIV-NAVA|non-invasive NAVA
697027|NCT01877720|O2|Outcome|NIV-PS|non-invasive PS
697038|NCT01877538|P1|Participant Flow|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy control subjects were scanned in this preliminary pilot study."
697039|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
697040|NCT01877538|O1|Outcome|[11C]Donepezil PET|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil"
697041|NCT01877538|E1|Reported Event|[11C]Donepezil|"[11C]donepezil is a radiopharmaceutical. It is evaluated whether the binding in peripheral tissues is in accordance with known distribution of the parasympathetic nervous system~[11C]donepezil PET: Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil~7 healthy controls were PET scanned in this preliminary study.~No adverse events were detected."
697042|NCT01877408|B3|Baseline|Total|Total of all reporting groups
697043|NCT01877408|B2|Baseline|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697044|NCT01877408|B1|Baseline|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697045|NCT01877408|P2|Participant Flow|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697142|NCT01876784|E1|Reported Event|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
697050|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697051|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697052|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697053|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697054|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697055|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697056|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697057|NCT01877408|O1|Outcome|Physicians|The generalist doctors in this study were moderately experienced in open surgical circumcision but had not previously used the Unicirc instruments.
697058|NCT01877408|O2|Outcome|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697059|NCT01877408|O1|Outcome|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697060|NCT01877408|E2|Reported Event|Unicirc Device With Tissue Adhesive|Coupling removal of the foreskin using the disposable Unicirc device with wound sealing using tissue adhesive results in a procedure that can be performed by generalist doctors with minimal training.
697061|NCT01877408|E1|Reported Event|Open Surgical Circumcision|The open surgical technique, which is commonly used for circumcision in South Africa, requires good surgical skills and minor complications are common.
697062|NCT01877343|B4|Baseline|Total|Total of all reporting groups
697063|NCT01877343|B3|Baseline|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697064|NCT01877343|B2|Baseline|Pediatric Heart Transplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697065|NCT01877343|B1|Baseline|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697163|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697066|NCT01877343|P7|Participant Flow|Adult Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697067|NCT01877343|P6|Participant Flow|Pediatric Controls|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697068|NCT01877343|P5|Participant Flow|Pediatric Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697069|NCT01877343|P4|Participant Flow|Adult Fontan|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697143|NCT01876732|B1|Baseline|Vitamin B12|Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.
697564|NCT01872611|E2|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
697070|NCT01877343|P3|Participant Flow|Adult Heart Failure|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697071|NCT01877343|P2|Participant Flow|Pediatric Heart Tansplant (1b)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697072|NCT01877343|P1|Participant Flow|Adult Heart Transplant (1a)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697073|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697074|NCT01877343|O1|Outcome|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697075|NCT01877343|E1|Reported Event|CVInsight (TM)|"Patient will be placed on a tilt table and pulse oximetry (Nonin Medical)and blood pressure will be measured at different table positions (different angles). A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.~CVInsight(TM): Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings."
697076|NCT01877278|B3|Baseline|Total|Total of all reporting groups
697077|NCT01877278|B2|Baseline|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
697078|NCT01877278|B1|Baseline|Active|"emitting group~Wearable pulsed electromagnetic fields"
697079|NCT01877278|P2|Participant Flow|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
697080|NCT01877278|P1|Participant Flow|Active|"emitting group~Wearable pulsed electromagnetic fields"
697081|NCT01877278|O2|Outcome|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
697082|NCT01877278|O1|Outcome|Active|"emitting group~Wearable pulsed electromagnetic fields"
697083|NCT01877278|O2|Outcome|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
697084|NCT01877278|O1|Outcome|Active|"emitting group~Wearable pulsed electromagnetic fields"
697085|NCT01877278|E2|Reported Event|Placebo|"non emitting device~Wearable pulsed electromagnetic fields"
697086|NCT01877278|E1|Reported Event|Active|"emitting group~Wearable pulsed electromagnetic fields"
697087|NCT01877161|B1|Baseline|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants.~3 sessions of rTMS were determined by a random sequence (eg. MTG-STG-Sham, Sham-MTG-STG, STG-MTG-Sham etc.) MTG: middle temporal gyrus STG: superior temporal gyrus~The sequence of stimulation was counter-balanced across subjects. different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
697088|NCT01877161|P1|Participant Flow|rTMS Over MTG, STG, Sham|"3 sessions of Repetitive magnetic stimulation (rTMS) were applied to participants 3 sessions of rTMS were determined by a random sequence (eg. middle temporal gyrus (MTG)-superior temporal gyrus (STG)-Sham, Sham-MTG-STG, STG-MTG-Sham etc..0) The sequence of stimulation was counter-balanced across subjects.~different sessions was performed after washout period (at least 3 days). The coil was placed perpendicularly to the scalp during sham rTMS sessions."
697089|NCT01877161|O3|Outcome|Sham rTMS|The coil was placed perpendicularly to the scalp during sham rTMS sessions.
697090|NCT01877161|O2|Outcome|rTMS Over STG|Repetitive magnetic stimulation (rTMS) were applied over STG
697091|NCT01877161|O1|Outcome|rTMS Over MTG|Repetitive magnetic stimulation (rTMS) were applied over MTG
697092|NCT01877161|E3|Reported Event|Superior Temporal Gyrus|"Repetitive magnetic stimulation to superior temporal gyrus~Repetitive magnetic stimulation to superior temporal gyrus: Repetitive magnetic stimulation to superior temporal gyrus"
697093|NCT01877161|E2|Reported Event|Control Group|"Repetitive magnetic stimulation (Sham)~Repetitive magnetic stimulation (Sham): Repetitive magnetic stimulation (Sham)"
697094|NCT01877161|E1|Reported Event|Middle Temporal Gyrus|"Repetitive magnetic stimulation to middle temporal gyrus~Repetitive magnetic stimulation to middle temporal gyrus: Repetitive magnetic stimulation to middle temporal gyrus"
697095|NCT01877148|B3|Baseline|Total|Total of all reporting groups
697179|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697180|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697181|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697096|NCT01877148|B2|Baseline|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697097|NCT01877148|B1|Baseline|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697098|NCT01877148|P2|Participant Flow|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697099|NCT01877148|P1|Participant Flow|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697100|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697101|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697102|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697103|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
733934|NCT01676298|E7|Reported Event|*2/*3 CYP2C19 Genotype|
697104|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697105|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697106|NCT01877148|O2|Outcome|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697107|NCT01877148|O1|Outcome|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697182|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697183|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697665|NCT01871558|B3|Baseline|Total|Total of all reporting groups
697108|NCT01877148|E2|Reported Event|Physiotherapy + Sham tDCS|"The patients will be submit to sham tDCS and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697109|NCT01877148|E1|Reported Event|Physiotherapy + Anodal tDCS|"The patients will be submit to anodal tDCS applied in the motor cortex and after the patient will be submit to a 30 minutes of physiotherapy protocol.~Transcranial direct current stimulation: tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability~Physiotherapy"
697110|NCT01876823|B1|Baseline|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697111|NCT01876823|P1|Participant Flow|Es-citalopram and Memantine Treatment|This group received concurrent es-citalopram plus memantine treatment for 48 weeks. Patients ranged in age from 50-90 years old. Es-citalopram treatment began at 10mg per day for two weeks and was increased to 20mg per day for the 48 week duration. If a patient had an inadequate response to the antidepressant on two consecutive visits, the study physician used an alternative. At two weeks into the study, the patients were started on memantine 5mg, and the maximum dose of 20mg was reached by the six week point.
697112|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697113|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697114|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697115|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697116|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697117|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697118|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697119|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697120|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697121|NCT01876823|O1|Outcome|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697122|NCT01876823|E1|Reported Event|Es-citalopram and Memantine Treatment|concurrent es-citalopram plus memantine were administered for 48 weeks.
697123|NCT01876810|B1|Baseline|All Study Participants|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.~Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks. or One lactose pill twice a day for two weeks."
697124|NCT01876810|P2|Participant Flow|Placebo/Gemfibrozil|Participants received 1 capsule of placebo for 2 weeks. Then a washout period of 1 week of no medication. Then they received 600 mg of gemfibrozil (one capsule) twice daily for two weeks.
697125|NCT01876810|P1|Participant Flow|Gemfibrozil/Placebo|Participants received 600 mg of gemfibrozil (one capsule) twice daily for two weeks. Then a washout period of 1 week of no medication. Then they received 1 capsule of placebo twice daily for 2 weeks
697126|NCT01876810|O2|Outcome|Placebo Group|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
697128|NCT01876810|O2|Outcome|Placebo Group|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
697129|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after the washout period.
697130|NCT01876810|O2|Outcome|Placebo|Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period.
697131|NCT01876810|O1|Outcome|Gemfibrozil|Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study or during the second phase after a washout period .
697132|NCT01876810|E2|Reported Event|Placebo/Gemfibrozil|"One lactose pill twice a day for two weeks.~Participants taking Placebo (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of gemfibrozil twice daily for 2 weeks"
697133|NCT01876810|E1|Reported Event|Gemfibrozil/Placebo|"600 mg of gemfibrozil (one capsule) twice daily for two weeks.~Participants taking Gemfibrozil: 600 mg of gemfibrozil (one capsule) twice daily for two weeks during the 1st phase of the study followed by a the washout period. Then they received 1 capsule of placebo twice daily for 2 weeks"
697134|NCT01876784|B3|Baseline|Total|Total of all reporting groups
697135|NCT01876784|B2|Baseline|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
697136|NCT01876784|B1|Baseline|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
697137|NCT01876784|P2|Participant Flow|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
697138|NCT01876784|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
697139|NCT01876784|O2|Outcome|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
697140|NCT01876784|O1|Outcome|Vandetanib|Vandetanib 300 mg tablet, orally once daily until disease progression or death.
697141|NCT01876784|E2|Reported Event|Placebo|Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
697144|NCT01876732|P1|Participant Flow|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
697145|NCT01876732|O1|Outcome|Vitamin B12|"Those with an methylmalonic acid (MMA) over 800nmol/L are given 1000mcg of intramuscular (IM) vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B 12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment."
697146|NCT01876732|O1|Outcome|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
697147|NCT01876732|E1|Reported Event|Vitamin B12|"Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months.~Vitamin B12: Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first HD session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a KDQOL-36 prior to therapy and again post treatment."
697148|NCT01876706|B1|Baseline|UroLift Arm|Subjects that undergo the UroLift System procedure
697149|NCT01876706|P1|Participant Flow|UroLift Arm|Subjects that undergo the UroLift System procedure
697150|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697151|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697152|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697153|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697154|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697155|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697156|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697157|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697158|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697159|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697160|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697161|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697162|NCT01876706|O1|Outcome|UroLift Arm|Subjects that undergo the UroLift System procedure
697166|NCT01876368|B2|Baseline|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697167|NCT01876368|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697168|NCT01876368|P2|Participant Flow|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697169|NCT01876368|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697170|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697171|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697172|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697173|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697174|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697175|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697176|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697177|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697178|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697185|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697186|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697187|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697188|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697189|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697190|NCT01876368|O2|Outcome|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697191|NCT01876368|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697192|NCT01876368|E2|Reported Event|Olmesartan 20 mg|Patients will be treated with one placebo of LCZ696 200 mg tablet and one olmesartan 20 mg capsule once daily for 8 weeks.
697193|NCT01876368|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of olmesartan 20 mg capsule once daily for 8 weeks.
697194|NCT01876329|B4|Baseline|Total|Total of all reporting groups
697195|NCT01876329|B3|Baseline|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
697196|NCT01876329|B2|Baseline|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
697197|NCT01876329|B1|Baseline|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
697198|NCT01876329|P3|Participant Flow|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
697199|NCT01876329|P2|Participant Flow|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
697200|NCT01876329|P1|Participant Flow|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
697201|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
697202|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
697203|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
697204|NCT01876329|O3|Outcome|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
697205|NCT01876329|O2|Outcome|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
697206|NCT01876329|O1|Outcome|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
697207|NCT01876329|E3|Reported Event|Control|Participants without Rheumatoid Arthritis, AITD, or other systemic or organ specific autoimmune illnesses
697208|NCT01876329|E2|Reported Event|Autoimmune Thyroid Disease (AITD)|Participants with autoimmune thyroid disease without other known systemic or organ specific autoimmune illnesses.
697209|NCT01876329|E1|Reported Event|Rheumatoid Arthritis|Patients with seropositive or seronegative Rheumatoid Arthritis
697210|NCT01875991|B3|Baseline|Total|Total of all reporting groups
697211|NCT01875991|B2|Baseline|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
697212|NCT01875991|B1|Baseline|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
697213|NCT01875991|P2|Participant Flow|Autoinjector B / Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks, and then switched over to Autoinjector A for an additional 4 weeks of treatment.
733935|NCT01676298|E6|Reported Event|*17/*17 CYP2C19 Genotype|
697214|NCT01875991|P1|Participant Flow|Autoinjector A / Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks, and then switched over to Autoinjector B for an additional 4 weeks of treatment.
697215|NCT01875991|O2|Outcome|Autoinjector B Preference|Participants who preferred Autoinjector B overall
697216|NCT01875991|O1|Outcome|Autoinjector A Preference|Participants who preferred Autoinjector A overall
697217|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697218|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697219|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697220|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697221|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697222|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697223|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697224|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697225|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697226|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697227|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697228|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697229|NCT01875991|O2|Outcome|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697230|NCT01875991|O1|Outcome|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697231|NCT01875991|O1|Outcome|Primary Analysis Set|Participants who received at least one injection with each autoinjector and completed the Subject Preference Questionnaire.
697232|NCT01875991|E2|Reported Event|Autoinjector B|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector B for 4 weeks.
697233|NCT01875991|E1|Reported Event|Autoinjector A|Participants self-injected 50 mg etanercept once a week (RA) or twice a week (PsO) using Autoinjector A for 4 weeks.
697234|NCT01875978|B3|Baseline|Total|Total of all reporting groups
697235|NCT01875978|B2|Baseline|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
697236|NCT01875978|B1|Baseline|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
697237|NCT01875978|P2|Participant Flow|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
697238|NCT01875978|P1|Participant Flow|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
697239|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
697240|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
697241|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
697242|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
697243|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo first, then phytosterols 1.8g/day
697244|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|phytosterols 1.8g/day first, then placebo.
697245|NCT01875978|O2|Outcome|Group B:Placebo-phytosterols|Placebo for 4 weeks, washout 2 weeks, then daily 1.8g phytosterols powder for 4 weeks
697246|NCT01875978|O1|Outcome|Group A:Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2weeks, then placebo for 4 weeks
697247|NCT01875978|E2|Reported Event|Group B: Placebo-phytosterols|placebo for 4 weeks, washout 2 weeks. then daily 1.8 g phytosterols for 4 weeks
697248|NCT01875978|E1|Reported Event|Group A: Phytosterols-placebo|Daily 1.8g phytosterols powder for 4 weeks, washout 2 weeks, then placebo for 4 weeks
697249|NCT01875848|B3|Baseline|Total|Total of all reporting groups
697250|NCT01875848|B2|Baseline|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
697251|NCT01875848|B1|Baseline|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
697252|NCT01875848|P2|Participant Flow|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
697253|NCT01875848|P1|Participant Flow|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
697254|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
697255|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
697256|NCT01875848|O2|Outcome|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
697257|NCT01875848|O1|Outcome|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
697258|NCT01875848|E2|Reported Event|Opioid Dose Escalation|"increase of up to 25% of current opioid dose~opioid dose escalation: up to 25% increase in patient's current opioid dose"
697259|NCT01875848|E1|Reported Event|Buprenorphine/Naloxone|"induction onto buprenorphine/naloxone from opioid treatment~buprenorphine/naloxone: partial opioid agonist"
697261|NCT01875731|B2|Baseline|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
697262|NCT01875731|B1|Baseline|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
697263|NCT01875731|P2|Participant Flow|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
697264|NCT01875731|P1|Participant Flow|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
697265|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
697266|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
697267|NCT01875731|O2|Outcome|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
697268|NCT01875731|O1|Outcome|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
697269|NCT01875731|E2|Reported Event|Guideline|"Strategy based on enforced guideline guided antibiotic use~Guideline: Strategy based on enforced guideline guided antibiotic use"
697270|NCT01875731|E1|Reported Event|BPS (Bacterial Pneumonia Score)|"Strategy based on BPS guided antibiotic use~BPS: In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline."
697272|NCT01875510|B2|Baseline|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
697273|NCT01875510|B1|Baseline|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
697274|NCT01875510|P2|Participant Flow|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
697275|NCT01875510|P1|Participant Flow|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
697276|NCT01875510|O2|Outcome|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
697277|NCT01875510|O1|Outcome|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
697278|NCT01875510|E2|Reported Event|Soybean-oil Emulsion|Preterm infants will receive a soybean-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and the third day and after 3gr/kg
697279|NCT01875510|E1|Reported Event|Fish-oil Emulsions|Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg.
697280|NCT01875471|B3|Baseline|Total|Total of all reporting groups
697281|NCT01875471|B2|Baseline|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
697282|NCT01875471|B1|Baseline|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
697283|NCT01875471|P2|Participant Flow|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
697284|NCT01875471|P1|Participant Flow|Delefilcon A|Spherical daily disposable soft contact lens
697285|NCT01875471|O2|Outcome|Narafilcon A|Spherical daily disposable soft contact lens with UV blocking
697286|NCT01875471|O1|Outcome|Delefilcon A|Spherical daily disposable soft contact lens
697287|NCT01875471|E2|Reported Event|Narafilcon A|"Spherical daily disposable soft contact lens Class 1 UV blocking~narafilcon A: Daily disposable contact lens to be worn at least 8 hours daily"
697288|NCT01875471|E1|Reported Event|Delefilcon A|"Spherical daily disposable soft contact lens~delefilcon A: Daily disposable soft contact lens to be worn at least 8 hours daily"
697289|NCT01875445|B3|Baseline|Total|Total of all reporting groups
697290|NCT01875445|B2|Baseline|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697291|NCT01875445|B1|Baseline|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697292|NCT01875445|P2|Participant Flow|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697293|NCT01875445|P1|Participant Flow|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697294|NCT01875445|O2|Outcome|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697295|NCT01875445|O1|Outcome|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697296|NCT01875445|O2|Outcome|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697297|NCT01875445|O1|Outcome|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697756|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697298|NCT01875445|E2|Reported Event|Inositol|"Powder form, 2g TID up to 6g TID~Inositol: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697299|NCT01875445|E1|Reported Event|Placebo|"Matched dosage of inositol daily.~Placebo: Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study."
697300|NCT01875159|B3|Baseline|Total|Total of all reporting groups
697301|NCT01875159|B2|Baseline|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
697302|NCT01875159|B1|Baseline|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
697303|NCT01875159|P2|Participant Flow|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
697304|NCT01875159|P1|Participant Flow|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
697305|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
697306|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
697307|NCT01875159|O2|Outcome|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
697308|NCT01875159|O1|Outcome|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
697309|NCT01875159|E2|Reported Event|Active Comparator: no Caffeine|Compare extended use of caffeine citrate 6 mg/kg/day to no caffeine (usual care) in regard to extent of intermittent hypoxia from 35 weeks postmenstrual age (PMA) to 40 weeks PMA.
697310|NCT01875159|E1|Reported Event|Caffeine|"Caffeine citrate 6 mg/kg/day~Caffeine citrate 6 mg/kg/day: Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age."
697311|NCT01874951|B3|Baseline|Total|Total of all reporting groups
697312|NCT01874951|B2|Baseline|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697313|NCT01874951|B1|Baseline|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697314|NCT01874951|P2|Participant Flow|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697315|NCT01874951|P1|Participant Flow|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697316|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697317|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697318|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive low dose naltrexone for three weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697319|NCT01874951|O1|Outcome|Placebo|"In this arm, patients will receive placebo for three weeks.~Placebo: Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo."
697320|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks.1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697321|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697322|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697323|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697324|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697325|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697326|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697327|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697328|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697329|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697330|NCT01874951|O2|Outcome|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697757|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697331|NCT01874951|O1|Outcome|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697332|NCT01874951|E2|Reported Event|Naltrexone|In this arm, patients will receive active naltrexone for 3 weeks. 1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
697333|NCT01874951|E1|Reported Event|Placebo|In this arm, patients will receive placebo for 3 weeks. Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
697334|NCT01874665|B3|Baseline|Total|Total of all reporting groups
697335|NCT01874665|B2|Baseline|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)~ponatinib: 45 mg, taken orally once-daily"
697336|NCT01874665|B1|Baseline|Cohort A|"Patients with KIT exon 11-mutant GIST~ponatinib: 45 mg, taken orally once-daily"
697337|NCT01874665|P2|Participant Flow|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)~ponatinib: 45 mg, taken orally once-daily"
697338|NCT01874665|P1|Participant Flow|Cohort A|"Patients with KIT exon 11-mutant GIST~ponatinib: 45 mg, taken orally once-daily"
697339|NCT01874665|O1|Outcome|Cohort B|"Patients with GIST that lack KIT exon 11 mutations (Cohort B)~ponatinib: 45 mg, taken orally once-daily"
697340|NCT01874665|O1|Outcome|Cohort A|"Patients with KIT exon 11-mutant GIST~ponatinib: 45 mg, taken orally once-daily"
697341|NCT01874665|E1|Reported Event|Cohorts A & B|All patients with GIST (with and without) KIT exon 11 mutations
697342|NCT01874340|B5|Baseline|Total|Total of all reporting groups
697343|NCT01874340|B4|Baseline|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697344|NCT01874340|B3|Baseline|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697345|NCT01874340|B2|Baseline|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697346|NCT01874340|B1|Baseline|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697347|NCT01874340|P4|Participant Flow|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697348|NCT01874340|P3|Participant Flow|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697349|NCT01874340|P2|Participant Flow|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697350|NCT01874340|P1|Participant Flow|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697351|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697352|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697353|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697354|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697355|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697356|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697357|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697358|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697359|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697360|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697361|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697362|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697363|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697364|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697365|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697366|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697367|NCT01874340|O4|Outcome|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697368|NCT01874340|O3|Outcome|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697369|NCT01874340|O2|Outcome|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697370|NCT01874340|O1|Outcome|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697371|NCT01874340|E4|Reported Event|Placebo|Matching placebo will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697372|NCT01874340|E3|Reported Event|AIN457 3 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697373|NCT01874340|E2|Reported Event|AIN457 7 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697374|NCT01874340|E1|Reported Event|AIN457 15 mg/kg|AIN457 will be administered intravenously at day1, Week 2, week 4 and every 4 weeks therafter.
697375|NCT01874275|B3|Baseline|Total|Total of all reporting groups
697376|NCT01874275|B2|Baseline|Device Sham|placebo treatment - no nerve stimulator treatment twice daily for 180 days of study
697377|NCT01874275|B1|Baseline|VECTTOR - Active|nerve stimulator treatment twice daily for duration of study - 365 days ...
697512|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)~Naltrexone: Adults with ADHD"
697378|NCT01874275|P2|Participant Flow|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by active treatment for the duration of study, 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
697379|NCT01874275|P1|Participant Flow|VECTTOR|"muscle stimulator treatment twice daily for duration of study - 365 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
697380|NCT01874275|O1|Outcome|VECTTOR|Muscle strength testing (Wireless Tracker system) - All muscle strength testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in muscle strength. JTech computerized testing system determined the muscle strength by radio signals from a strain gauge measuring strength of the participant's muscles. 44 separate tests were performed for muscle strength for each participant at each time interval. Efficacy is defined as an increase in the strength measurement (pounds) from Baseline to 365 days.
697403|NCT01874145|P1|Participant Flow|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697404|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697476|NCT01873950|B1|Baseline|All Study Participants|Participants who were randomized to receive either ranolazine, dofetilide, verapamil, quinidine or placebo.
697381|NCT01874275|O1|Outcome|VECTTOR|Range of Motion (ROM) testing (Wireless Tracker System) - All muscle and joint testing was performed using the JTech computerized testing system, including Goniometry, Grip Testing, Inclinometry, Muscle Testing and Joint Range of Motion. Testing occurred at Baseline (Day 0), 30, 60, 90, 180 and 365 days to determine changes in joint Range of Motion. JTech computerized testing system determined the joint range of motion by radio signals from a goniometer measuring movement of the participants' joints. 44 separate tests were performed for Range of Motion for each participant at each time interval. The results from the range of motion tests were averaged the percent change from baseline to 365 days. Efficacy is defined as an increase in range of motion.
697382|NCT01874275|O2|Outcome|Device - Sham|"placebo treatment - no electrical stimulation treatment twice daily for 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
697383|NCT01874275|O1|Outcome|VECTTOR|"nerve stimulator treatment twice daily for duration of study - 180 days~VECTTOR: The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient’s feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
697384|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by muscle stimulator treatment twice daily for 180 days
697385|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study
697386|NCT01874275|O2|Outcome|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
697387|NCT01874275|O1|Outcome|VECTTOR|nerve stimulator treatment twice daily for duration of study - assessed at 180 days
697388|NCT01874275|E2|Reported Event|Device - Sham|placebo treatment - no electrical stimulation treatment twice daily for 180 days followed by cross-over with active treatment for the next 180 days
697389|NCT01874275|E1|Reported Event|VECTTOR|nerve stimulator treatment twice daily for duration of study - 365 days ...
697390|NCT01874262|B3|Baseline|Total|Total of all reporting groups
697391|NCT01874262|B2|Baseline|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
697392|NCT01874262|B1|Baseline|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
697393|NCT01874262|P2|Participant Flow|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
697394|NCT01874262|P1|Participant Flow|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
697452|NCT01874132|E2|Reported Event|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697395|NCT01874262|O2|Outcome|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
697396|NCT01874262|O1|Outcome|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
697397|NCT01874262|E2|Reported Event|E-diary|In this group the patients had access to the e-diary only, in which they reported their daily use of ticagrelor. Patients did not receive any feed-back except a reminder in case of a missing ticagrelor registration (which was applicable also for the other group receiving e-diary + the mobile-phone based patient support).
697398|NCT01874262|E1|Reported Event|E-diary + Mobile-phone Based Patient Support|The software application used on the patients' smart phones in this group, contained both the e-diary and the mobile-phone based patient support. Patients received feedback by the mobile-phone based patient support not only on the data they entered into the mobile-phone based patient support but also on their reported daily ticagrelor use.
697399|NCT01874145|B3|Baseline|Total|Total of all reporting groups
697400|NCT01874145|B2|Baseline|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697401|NCT01874145|B1|Baseline|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697402|NCT01874145|P2|Participant Flow|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697464|NCT01873989|B2|Baseline|Waitlist Control|"This arm involves watchful waiting.~Waitlist control"
697405|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697406|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697407|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697408|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697409|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697410|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697411|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697412|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697413|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697414|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697415|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697416|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697417|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697418|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697419|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697420|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697453|NCT01874132|E1|Reported Event|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697421|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697422|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697423|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697424|NCT01874145|O2|Outcome|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697425|NCT01874145|O1|Outcome|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697426|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697427|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697428|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697429|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697465|NCT01873989|B1|Baseline|Testosterone Replacement|"Testosterone replacement for hypogonadism.~Testosterone replacement"
697430|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697431|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697432|NCT01874145|O2|Outcome|GA 40 mg/mL TIW (Core and Extension)|"Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.~During the Extension period, participants to continue treatment with GA 40 mg/mL TIW until this dose regimen was commercially available for the treatment of RRMS."
697433|NCT01874145|O1|Outcome|GA 20 mg/mL QD (Core); 40 mg/mL TIW (Extension)|"Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.~Participants then switched to 40 mg/mL 3 times a week (TIW) dosing if they chose to continue into the extension period."
697434|NCT01874145|E4|Reported Event|Non-Switchers: GA 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week in both the core and extension periods.
697435|NCT01874145|E3|Reported Event|Switchers: 40 mg/mL TIW (Extension)|Participants who took glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period. Then switched to 40 mg/mL 3 times a week (TIW) dosing in the extension period.
697436|NCT01874145|E2|Reported Event|GA 40 mg/mL TIW (Core)|Glatiramer acetate (GA) 40 mg in 1 mL SC injection administered three times a week (TIW) for the 4 months of the core period.
697437|NCT01874145|E1|Reported Event|GA 20 mg/mL QD (Core)|Glatiramer acetate (GA) 20 mg in 1 mL SC injection administered every day (QD) for the 4 months of the core period.
697438|NCT01874132|B4|Baseline|Total|Total of all reporting groups
697439|NCT01874132|B3|Baseline|Control|Non-exercising control group
697440|NCT01874132|B2|Baseline|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697441|NCT01874132|B1|Baseline|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697442|NCT01874132|P3|Participant Flow|Control|Non-exercising control group
697443|NCT01874132|P2|Participant Flow|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697444|NCT01874132|P1|Participant Flow|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697445|NCT01874132|O3|Outcome|Control|Non-exercising control group
697446|NCT01874132|O2|Outcome|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697447|NCT01874132|O1|Outcome|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697448|NCT01874132|O3|Outcome|Control|Non-exercising control group
697449|NCT01874132|O2|Outcome|Aerobic and Resistance Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697450|NCT01874132|O1|Outcome|Aerobic Exercise Training|"Dose response~Exercise training: Both training programs were of moderate-to-vigorous intensity, three days per week for nine months."
697454|NCT01874054|B1|Baseline|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697455|NCT01874054|P1|Participant Flow|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697456|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697457|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697458|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697459|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697460|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697461|NCT01874054|O1|Outcome|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697462|NCT01874054|E1|Reported Event|Brentuximab Vedotin + Bendamustine|"Brentuximab vedotin 1.8mg/kg every 3 weeks and bendamustine~brentuximab vedotin: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion~bendamustine: 90 mg/m2 on Days 1 and 2 of 3-week cycles"
697463|NCT01873989|B3|Baseline|Total|Total of all reporting groups
697477|NCT01873950|P5|Participant Flow|Placebo|Single oral dose of Placebo (comparison group). Each subject received each drug only once in a randomized sequence (10 sequences in total).
697478|NCT01873950|P4|Participant Flow|Quinidine Sulfate 400 mg|Single oral dose of Quinidine sulfate 400mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
697479|NCT01873950|P3|Participant Flow|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
697480|NCT01873950|P2|Participant Flow|Dofetilide 500 mcg|Single oral dose of Dofetilide 500mcg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
697481|NCT01873950|P1|Participant Flow|Ranolazine 1500 mg|Single oral dose of Ranolazine 1500mg. Each subject received each drug only once in a randomized sequence (10 sequences in total).
697482|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
697483|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
697484|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
697485|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
697486|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
697487|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
697488|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
697489|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
697490|NCT01873950|O4|Outcome|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
697491|NCT01873950|O3|Outcome|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
697492|NCT01873950|O2|Outcome|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
697493|NCT01873950|O1|Outcome|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
697494|NCT01873950|E5|Reported Event|Placebo|Single oral dose of Placebo (comparison group)
697495|NCT01873950|E4|Reported Event|Quinidine Sulfate 400mg|Single oral dose of Quinidine sulfate 400mg
697496|NCT01873950|E3|Reported Event|Verapamil HCl 120 mg|Single oral dose of Verapamil HCl 120 mg
697497|NCT01873950|E2|Reported Event|Dofetilide 500mcg|Single oral dose of Dofetilide 500mcg
697498|NCT01873950|E1|Reported Event|Ranolazine 1500mg|Single oral dose of Ranolazine 1500mg
697499|NCT01873859|B3|Baseline|Total|Total of all reporting groups
697500|NCT01873859|B2|Baseline|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
697501|NCT01873859|B1|Baseline|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
697502|NCT01873859|P2|Participant Flow|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
697503|NCT01873859|P1|Participant Flow|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
697504|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
697505|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: rise of creatinin 48 hr after recieving contrast media."
697506|NCT01873859|O2|Outcome|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
697507|NCT01873859|O1|Outcome|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
697508|NCT01873859|E2|Reported Event|Off-metformin|Diabetic patients receiving contrast media with discontinuation of metformin.
697509|NCT01873859|E1|Reported Event|On-metformin|"Diabetic patients receiving contrast media without discontinuing metformin.~Metformin: Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin."
697513|NCT01873729|O1|Outcome|Naltrexone|"Naltrexone + Methylphenidate Spheroidal Oral Drug Absorption System (MPH-SODAS)~Naltrexone: Adults with ADHD"
697514|NCT01873729|E1|Reported Event|Naltrexone|"Naltrexone~Naltrexone: Adults with ADHD"
697515|NCT01873417|B1|Baseline|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697516|NCT01873417|P1|Participant Flow|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697517|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697518|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697519|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697520|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697554|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
697555|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
697521|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697522|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697523|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697524|NCT01873417|O1|Outcome|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697525|NCT01873417|E1|Reported Event|Dimethyl Fumarate|120 mg dimethyl fumarate (DMF) twice daily (BID) for the first 7 days and 240 mg DMF BID thereafter for 12 weeks of treatment. Participants were instructed to take the DMF dose with food (with a meal or within 1 hour after a meal).
697526|NCT01872819|B1|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions"
697527|NCT01872819|P1|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions"
697528|NCT01872819|O1|Outcome|Treated Patients|14 patients were treated.
697529|NCT01872819|E1|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive 1 of 160 possible interventions based on high throughput drug sensitivity assay.~antitumor drug screening assay: Undergo high throughput drug sensitivity assay~chemotherapy: Patients receive 1 of 160 possible interventions~biological therapy: Patients receive 1 of 160 possible interventions"
697530|NCT01872715|B1|Baseline|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
697531|NCT01872715|P1|Participant Flow|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
697532|NCT01872715|O5|Outcome|Very Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697533|NCT01872715|O4|Outcome|Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697534|NCT01872715|O3|Outcome|Neither Satisfied Nor Dissatisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697535|NCT01872715|O2|Outcome|Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697536|NCT01872715|O1|Outcome|Very Satisfied|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697537|NCT01872715|O5|Outcome|4 = Severe|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697538|NCT01872715|O4|Outcome|3 = Moderate|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697539|NCT01872715|O3|Outcome|2 = Mild|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697540|NCT01872715|O2|Outcome|1 = Near Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697541|NCT01872715|O1|Outcome|0 = Clear|Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after; Oral dose for 12 weeks
697542|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
697543|NCT01872715|O1|Outcome|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
697544|NCT01872715|E1|Reported Event|Oracea|"Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.~Oral dose for 12 weeks~Oracea"
697545|NCT01872611|B3|Baseline|Total|Total of all reporting groups
697546|NCT01872611|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
697547|NCT01872611|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
697548|NCT01872611|P2|Participant Flow|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
697549|NCT01872611|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
697550|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
697551|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
697552|NCT01872611|O2|Outcome|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
697553|NCT01872611|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
697565|NCT01872611|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
697566|NCT01872078|B5|Baseline|Total|Total of all reporting groups
697567|NCT01872078|B4|Baseline|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
697568|NCT01872078|B3|Baseline|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
697569|NCT01872078|B2|Baseline|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
697570|NCT01872078|B1|Baseline|Placebo|Two matching placebo tablets for both the morning and evening doses
697571|NCT01872078|P4|Participant Flow|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
697572|NCT01872078|P3|Participant Flow|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
697573|NCT01872078|P2|Participant Flow|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
697574|NCT01872078|P1|Participant Flow|Placebo|Two matching placebo tablets for both the morning and evening doses
697575|NCT01872078|O4|Outcome|40 mg AZD4901 Bid|40 mg AZD4901 twice daily administered orally
697576|NCT01872078|O3|Outcome|20 mg AZD4901 Bid|20 mg AZD4901 twice daily administered orally
697577|NCT01872078|O2|Outcome|20 mg AZD4901 qd|20 mg AZD4901 once daily administered orally
697578|NCT01872078|O1|Outcome|Placebo|Two matching placebo tablets for both the morning and evening doses
697579|NCT01872078|E4|Reported Event|Placebo|Two matching placebo tablets for both the morning and evening doses
697580|NCT01872078|E3|Reported Event|40 mg AZD4901 Twice Daily|Two 20-mg AZD4901 tablets for both the morning and evening doses
697581|NCT01872078|E2|Reported Event|20 mg AZD4901 Twice Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for both the morning and evening doses
697582|NCT01872078|E1|Reported Event|20 mg AZD4901 Once Daily|One 20-mg AZD4901 tablet and 1 placebo tablet for the morning dose and 2 placebo tablets for the evening dose
697583|NCT01871870|B1|Baseline|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
697584|NCT01871870|P1|Participant Flow|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
697585|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
697683|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697586|NCT01871870|O1|Outcome|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
697587|NCT01871870|E1|Reported Event|Artificial Pancreas Control Software|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone."
697588|NCT01871805|B7|Baseline|Total|Total of all reporting groups
697589|NCT01871805|B6|Baseline|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697590|NCT01871805|B5|Baseline|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697989|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
697591|NCT01871805|B4|Baseline|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697592|NCT01871805|B3|Baseline|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697593|NCT01871805|B2|Baseline|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697594|NCT01871805|B1|Baseline|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697595|NCT01871805|P6|Participant Flow|Alectinib 600 mg (Fed): Phase II|Participants received 150 mg alectinib capsules orally to make a dose of 600 mg BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697596|NCT01871805|P5|Participant Flow|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697597|NCT01871805|P4|Participant Flow|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697598|NCT01871805|P3|Participant Flow|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697599|NCT01871805|P2|Participant Flow|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697600|NCT01871805|P1|Participant Flow|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 milligrams (mg) alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg twice daily (BID) dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697601|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697602|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697603|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697604|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697605|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697606|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697749|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697821|NCT01870999|B4|Baseline|Total|Total of all reporting groups
697607|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697608|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697609|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697610|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697611|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697612|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697613|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697614|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
701068|NCT01848899|B2|Baseline|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
697615|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697616|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697617|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697618|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697619|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697620|NCT01871805|O7|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697621|NCT01871805|O6|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697622|NCT01871805|O5|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697623|NCT01871805|O4|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697624|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697625|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697626|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697627|NCT01871805|O9|Outcome|Alectinib 900 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697628|NCT01871805|O8|Outcome|Alectinib 900 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697629|NCT01871805|O7|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697630|NCT01871805|O6|Outcome|Alectinib 600 mg (Fed): Phase I (150 mg)|Participants received single dose of 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697631|NCT01871805|O5|Outcome|Alectinib 600 mg (Fed): Phase I (20/40 mg)|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697632|NCT01871805|O4|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697633|NCT01871805|O3|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697634|NCT01871805|O2|Outcome|Alectinib 240 mg Once and 300 mg BID (Fed): Phase I|Participants (in non-fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697635|NCT01871805|O1|Outcome|Alectinib 240 mg Once and 300 mg BID (Fasted): Phase I|Participants (in fasting condition) received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697636|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697637|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697638|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697639|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697640|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697641|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697642|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697643|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697644|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697645|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697646|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697647|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697648|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697649|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697650|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697651|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697652|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697653|NCT01871805|O1|Outcome|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697654|NCT01871805|O5|Outcome|Alectinib 900 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697655|NCT01871805|O4|Outcome|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697750|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
733936|NCT01676298|E5|Reported Event|*1/*17 CYP2C19 Genotype|
697656|NCT01871805|O3|Outcome|Alectinib 600 mg (Fed): Phase I (20/40/150 mg)|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697657|NCT01871805|O2|Outcome|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697658|NCT01871805|O1|Outcome|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697659|NCT01871805|E6|Reported Event|Alectinib 600 mg (Fed): Phase II|Participants received 600 mg alectinib capsules orally BID from Cycle 1 Day 1 for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697660|NCT01871805|E5|Reported Event|Alectinib 900 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 900 mg on Cycle 1 Day -3 and then received 900 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697661|NCT01871805|E4|Reported Event|Alectinib 760 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 760 mg on Cycle 1 Day -3 and then received 760 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697662|NCT01871805|E3|Reported Event|Alectinib 600 mg (Fed): Phase I|Participants received single dose of 20 or 40 or 150 mg alectinib capsules orally to make a dose of 600 mg on Cycle 1 Day -3 and then received 600 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697663|NCT01871805|E2|Reported Event|Alectinib 460 mg (Fed): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 460 mg on Cycle 1 Day -3 and then received 460 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697664|NCT01871805|E1|Reported Event|Alectinib 300 mg (Fasted): Phase I|Participants received single dose of 20 or 40 mg alectinib capsules orally to make a dose of 240 or 300 mg on Cycle 1 Day -3 and then received 300 mg BID dose for 3-weekly cycles until disease progression, death or withdrawal for any other reasons.
697666|NCT01871558|B2|Baseline|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697667|NCT01871558|B1|Baseline|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697668|NCT01871558|P2|Participant Flow|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697669|NCT01871558|P1|Participant Flow|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697670|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697671|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697672|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697673|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697674|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697675|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697676|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697677|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697678|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697679|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697680|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697681|NCT01871558|O1|Outcome|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697682|NCT01871558|O2|Outcome|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697751|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697684|NCT01871558|E2|Reported Event|SU+Metformin + Basal Insulin|Randomized patient will remain on their previous dual therapy by SU+metformin, which will be kept unchanged, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697685|NCT01871558|E1|Reported Event|Metformin/Vildagliptin + Basal Insulin|Randomized patient will receive Vildagliptin 50 mg twice daily (b.i.d) + continued therapy with Metformin, + start of Basal Insulin up-titrated as per usual algorithms primarily based on FPG
697686|NCT01871532|B3|Baseline|Total|Total of all reporting groups
697687|NCT01871532|B2|Baseline|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697688|NCT01871532|B1|Baseline|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697689|NCT01871532|P2|Participant Flow|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697690|NCT01871532|P1|Participant Flow|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697691|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697692|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697693|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697694|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697695|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697696|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697697|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697698|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697699|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697752|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697753|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697754|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697700|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697701|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697702|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697703|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697704|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697705|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697706|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697707|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697708|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697709|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697710|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697711|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697712|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697713|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697714|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697715|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697716|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697717|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697718|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697719|NCT01871532|O2|Outcome|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697720|NCT01871532|O1|Outcome|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697721|NCT01871532|E2|Reported Event|Standard Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697722|NCT01871532|E1|Reported Event|Low Dose Gonal-f|Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
697723|NCT01871519|B1|Baseline|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697724|NCT01871519|P1|Participant Flow|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697725|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697726|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697727|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697728|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697729|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697755|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697730|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697731|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697732|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices"
697733|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697734|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697735|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697990|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
697736|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697737|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697738|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697739|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697740|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697741|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697742|NCT01871519|O1|Outcome|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697743|NCT01871519|E1|Reported Event|Balloon Kyphoplasty|"This group of patients were treated with balloon kyphoplasty in the treatment of painful, acute VCFs associated with either osteoporosis or cancer.~Balloon kyphoplasty: The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices."
697744|NCT01871402|B3|Baseline|Total|Total of all reporting groups
697745|NCT01871402|B2|Baseline|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697746|NCT01871402|B1|Baseline|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697747|NCT01871402|P2|Participant Flow|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697748|NCT01871402|P1|Participant Flow|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697758|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697759|NCT01871402|O2|Outcome|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697760|NCT01871402|O1|Outcome|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697761|NCT01871402|E2|Reported Event|Vehicle Arm|"Topical lotion, applied twice daily~Vehicle Lotion"
697762|NCT01871402|E1|Reported Event|Active Arm|"Topical lotion, applied twice daily~000-0551 Lotion"
697763|NCT01871285|B3|Baseline|Total|Total of all reporting groups
697764|NCT01871285|B2|Baseline|MSE Dose Group 2|Morning and evening dose of buprenorphine HCl buccal film (450 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
697765|NCT01871285|B1|Baseline|MSE Dose Group 1|Morning and evening dose of buprenorphine HCl buccal film (300 μg) + placebo capsule in one period, and then placebo buccal film + over-encapsulated ATC opioid at 50% MSE daily dose in the alternate period
697766|NCT01871285|P4|Participant Flow|MSE Dose Group 2 (BA) - ATC Opioid Then Buprenorphine (450 μg)|MSE Dose Group 2 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
697767|NCT01871285|P3|Participant Flow|MSE Dose Group 2 (AB) - Buprenorphine (450 μg) Then ATC Opioid|MSE Dose Group 2 receiving treatment sequence AB with A being buprenorphine HCl buccal film (450 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
701069|NCT01848899|B1|Baseline|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
697768|NCT01871285|P2|Participant Flow|MSE Dose Group 1 (BA) - ATC Opioid Then Buprenorphine (300 μg)|MSE Dose Group 1 receiving treatment sequence BA with B being ATC opioid + placebo buccal film morning and evening in period 1 and A being buprenorphine HCl buccal film (300 μg) + placebo ATC morning and evening in period 2. Each period included 1 treatment day.
697769|NCT01871285|P1|Participant Flow|MSE Dose Group 1 (AB) - Buprenorphine (300 μg) Then ATC Opioid|MSE Dose Group 1 receiving treatment sequence AB with A being buprenorphine hydrochloride (HCl) buccal film (300 μg) + placebo ATC morning and evening in period 1 and B being ATC opioid + placebo buccal film morning and evening in period 2. Each period included 1 treatment day.
697770|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697771|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
697772|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697773|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
697774|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697775|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
697776|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697777|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
697778|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697779|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
697780|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697781|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
697782|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697783|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
697784|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697785|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
697786|NCT01871285|O4|Outcome|MSE Dose Group 2 - ATC Opioid|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697787|NCT01871285|O3|Outcome|MSE Dose Group 2 - Buprenorphine|Subjects requiring 161-220 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (450 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to buprenorphine
697788|NCT01871285|O2|Outcome|MSE Dose Group 1 - ATC Opioid|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE TDD; following exposure to ATC opioid
697789|NCT01871285|O1|Outcome|MSE Dose Group 1 - Buprenorphine|Subjects requiring 80-160 mg MSE per day (ATC) received 2 doses of buprenorphine HCl buccal film (300 μg) and 2 doses of ATC opioid at 50% MSE total daily dose (TDD); following exposure to buprenorphine
697790|NCT01871285|E4|Reported Event|MSE Dose Group 2 - ATC Opioid|Subjects in MSE Dose Group 2 who received at least 1 dose of assigned ATC opioid in either period
697791|NCT01871285|E3|Reported Event|MSE Dose Group 2 - Buprenorphine|Subjects in MSE Dose Group 2 who received at least one 450-μg buprenorphine HCl buccal film in either period
697792|NCT01871285|E2|Reported Event|MSE Dose Group 1 - ATC Opioid|Subjects in MSE Dose Group 1 who received at least 1 dose of assigned ATC opioid in either period
697793|NCT01871285|E1|Reported Event|MSE Dose Group 1 - Buprenorphine|Subjects in MSE Dose Group 1 who received at least one 300-μg buprenorphine HCl buccal film in either period
697794|NCT01871142|B1|Baseline|Entire Study Population|All enrolled participant baseline data
697795|NCT01871142|P1|Participant Flow|Randomized Crossover Assignment|Participants will receive, in a random order, a placebo prior to exercise in normoxia, a placebo prior to exercise in hypoxia, 1000 mg of Aes-103 prior to exercise in hypoxia, and 3000 mg of Aes-103 prior to exercise in hypoxia. Each intervention is separated by a 7 day washout period.
697796|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Number of participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
697797|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Number of participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
697798|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Number of participants receiving placebo in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
697799|NCT01871142|O1|Outcome|Placebo + Normoxia|"Number of participants receiving placebo in normoxic conditions. Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
697800|NCT01871142|O4|Outcome|3000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
697801|NCT01871142|O3|Outcome|1000mg Aes-103 + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
697802|NCT01871142|O2|Outcome|Placebo + Hypoxia|"Randomized crossover assignment for each participant.~Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
697803|NCT01871142|O1|Outcome|Palcebo + Normoxia|"Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
697804|NCT01871142|E4|Reported Event|Hypoxia 3000 mg Aes-103 + Hypoxia|"Participants receiving 3000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen"
697805|NCT01871142|E3|Reported Event|1000 mg Aes-103 + Hypoxia|"Participants receiving 1000mg Aes-103 in hypoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% oxygen)"
697806|NCT01871142|E2|Reported Event|Placebo + Hypoxia|"Participants receiving placebo in Hypoxic conditions Randomized crossover assignment for each participant Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Hypoxia (15% Oxygen)"
697807|NCT01871142|E1|Reported Event|Placebo + Normoxia|"Participants receiving placebo in normoxic conditions Randomized crossover assignment for each participant. Intervention 1 dose. Next random crossover assignment was followed by a 7 day washout period.~Note: Normoxia (21% oxygen)"
697808|NCT01871090|B3|Baseline|Total|Total of all reporting groups
697809|NCT01871090|B2|Baseline|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
697810|NCT01871090|B1|Baseline|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
697811|NCT01871090|P2|Participant Flow|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
697812|NCT01871090|P1|Participant Flow|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
697813|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
697814|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
697815|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
697816|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
697817|NCT01871090|O2|Outcome|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
697818|NCT01871090|O1|Outcome|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
697819|NCT01871090|E2|Reported Event|Interrogation With Programmer|Interrogation with programmer according to usual standard of care
697820|NCT01871090|E1|Reported Event|Interrogation With Unpaired Remote Monitoring Transmitter|"Interrogation with an unpaired remote monitoring transmitter for devices that are compatible.~Unpaired remote monitoring transmitter"
697822|NCT01870999|B3|Baseline|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697823|NCT01870999|B2|Baseline|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697824|NCT01870999|B1|Baseline|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697825|NCT01870999|P3|Participant Flow|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697826|NCT01870999|P2|Participant Flow|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697991|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
697827|NCT01870999|P1|Participant Flow|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697828|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697829|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697830|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697831|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697832|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697833|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697834|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697835|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697836|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697837|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697838|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697839|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697840|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697841|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
699522|NCT01856322|O1|Outcome|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
697842|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697843|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697844|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697845|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697846|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697992|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
701076|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
697847|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697848|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697849|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697850|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697851|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697852|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697853|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697854|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697855|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697856|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697857|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697858|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697859|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697860|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697861|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697862|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697863|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697864|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697865|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697866|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697993|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
697994|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
697867|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697868|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697869|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697870|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697871|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697872|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697873|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697874|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697875|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697876|NCT01870999|O3|Outcome|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697877|NCT01870999|O2|Outcome|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697878|NCT01870999|O1|Outcome|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697879|NCT01870999|E3|Reported Event|200 mg Aripiprazole IM Depot|200 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697880|NCT01870999|E2|Reported Event|300 mg Aripiprazole IM Depot|300 mg aripiprazole IM depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697913|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697881|NCT01870999|E1|Reported Event|400 mg Aripiprazole IM Depot|400 mg aripiprazole IM (intramuscular) depot intramuscular injection once every 4 weeks for 5 months. All participants were on a stable dose of 10 mg aripiprazole tablets once daily in the morning for at least 14 days prior to randomization and continued 10 mg aripiprazole tablets once daily on days 1 to 14.
697882|NCT01870973|B3|Baseline|Total|Total of all reporting groups
697883|NCT01870973|B2|Baseline|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
697884|NCT01870973|B1|Baseline|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
697885|NCT01870973|P2|Participant Flow|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
697886|NCT01870973|P1|Participant Flow|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
697887|NCT01870973|O2|Outcome|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
701077|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
697888|NCT01870973|O1|Outcome|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
697889|NCT01870973|E2|Reported Event|no Root Canal Treatment|"no root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin if allergic 300 mg clindamycin)~no root canal treatment"
697890|NCT01870973|E1|Reported Event|Root Canal Treatment|"root canal treatment, anesthesia with 2% lidocaine with 1:100,000 epinephrine, pain medication (1000 mg acetaminophen and 600 mg ibuprofen every 6 hours)five day supply, antibiotic (500 mg penicillin, if allergic 300 mg clindamycin)~root canal treatment: Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device."
697891|NCT01870921|B1|Baseline|Ticargrelor|90 mg/tablet, 1 tablet bid
697892|NCT01870921|P1|Participant Flow|Ticargrelor|90 mg/tablet, 1 tablet bid
697893|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
697894|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
697895|NCT01870921|O1|Outcome|Ticargrelor|90 mg/tablet, 1 tablet bid
697896|NCT01870921|E1|Reported Event|Ticargrelor|90 mg/tablet, 1 tablet bid
697897|NCT01870856|B3|Baseline|Total|Total of all reporting groups
697898|NCT01870856|B2|Baseline|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697899|NCT01870856|B1|Baseline|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
697900|NCT01870856|P2|Participant Flow|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697901|NCT01870856|P1|Participant Flow|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
697902|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697903|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697904|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697905|NCT01870856|O1|Outcome|DAILIES TOTAL 1, Stage 2|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697906|NCT01870856|O2|Outcome|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697907|NCT01870856|O1|Outcome|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
697908|NCT01870856|E2|Reported Event|1-DAY ACUVUE, Stage 1|Contact lenses worn bilaterally (in both eyes) at least 5 days per week, at least 6 hours per day, for 2 weeks in a daily disposable mode
697909|NCT01870856|E1|Reported Event|Spectacles, Stage 1|Spectacles per participant's habitual perscription worn for 2 weeks
697910|NCT01870843|B1|Baseline|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697911|NCT01870843|P1|Participant Flow|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697912|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
699930|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
697914|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697915|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697916|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697917|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697918|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697919|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697920|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697921|NCT01870843|O1|Outcome|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697922|NCT01870843|E1|Reported Event|Escitalopram Oxalate|Participants received escitalopram 10 milligram (mg) per day for 1 week and then the dose of escitalopram flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
697923|NCT01870739|B3|Baseline|Total|Total of all reporting groups
697924|NCT01870739|B2|Baseline|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697925|NCT01870739|B1|Baseline|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697926|NCT01870739|P2|Participant Flow|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697927|NCT01870739|P1|Participant Flow|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697928|NCT01870739|O6|Outcome|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
697929|NCT01870739|O5|Outcome|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
697930|NCT01870739|O4|Outcome|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
697931|NCT01870739|O3|Outcome|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
697932|NCT01870739|O2|Outcome|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
697933|NCT01870739|O1|Outcome|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
697934|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697935|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697936|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697937|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697938|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697939|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697940|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697941|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697942|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697943|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697944|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697945|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697946|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697947|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697948|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697949|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697950|NCT01870739|O2|Outcome|Olmesartan|Olmesartan based treatment strategy (olmesartan 20 mg for 2 weeks as initiation dose, olmesartan 40 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697951|NCT01870739|O1|Outcome|Sacubitril/Valsartan (LCZ696)|LCZ696 based treatment strategy (LCZ696 200 mg for 2 weeks as initiation dose, LCZ696 400 mg for additional 50 weeks as maintenance dose. Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target)
697952|NCT01870739|E6|Reported Event|Olmesartan 40mg +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
697953|NCT01870739|E5|Reported Event|Sacubitril/Valsartan (LCZ696 400mg) +/- Amlodipine|Optional amlodipine 2.5 to 10 mg add-on after Week 12 to reach blood pressure target
697954|NCT01870739|E4|Reported Event|Maintenance Dose: Olmesartan 40 mg|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of olmesartan 40 mg for 10 weeks
697955|NCT01870739|E3|Reported Event|Maintenance Dose: Sacubitril/Valsartan (LCZ696 400mg)|After 2 weeks on initiation dose, patients were dosed at the maintenance dose level of LCZ696 400 mg for 10 weeks
697956|NCT01870739|E2|Reported Event|Initiation Dose: Olmesartan 20mg|Patients received olmesartan 20 mg for 2 weeks as initiation dose for 2 weeks
697957|NCT01870739|E1|Reported Event|Initiation Dose : Sacubitril/Valsartan (LCZ696 200mg)|Patients received LCZ696 200 mg for 2 weeks as initiation dose for 2 weeks
697958|NCT01870596|B3|Baseline|Total|Total of all reporting groups
697959|NCT01870596|B2|Baseline|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697960|NCT01870596|B1|Baseline|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697961|NCT01870596|P2|Participant Flow|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697962|NCT01870596|P1|Participant Flow|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697963|NCT01870596|O2|Outcome|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697964|NCT01870596|O1|Outcome|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697965|NCT01870596|E2|Reported Event|Arm B (Cytarabine)|"Patients receive cytarabine as in Arm A.~Cytarabine: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697966|NCT01870596|E1|Reported Event|Arm A (Cytarabine, Chk1 Inhibitor SCH 900776)|"Patients receive cytarabine IV continuously over 72 hours on days 1-3 and 10-12 and Chk1 inhibitor SCH 900776 IV over 30 minutes on days 2, 3, 11, and 12.~Cytarabine: Given IV~CHK1 Inhibitor SCH 900776: Given IV~Laboratory Biomarker Analysis: Correlative studies"
697967|NCT01870388|B3|Baseline|Total|Total of all reporting groups
697968|NCT01870388|B2|Baseline|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
697969|NCT01870388|B1|Baseline|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
697970|NCT01870388|P2|Participant Flow|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
697971|NCT01870388|P1|Participant Flow|Baricitinib (Healthy Participants)|Group 1: A single 4-milligram (mg) dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
697972|NCT01870388|O2|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
697973|NCT01870388|O1|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
733937|NCT01676298|E4|Reported Event|*3/*1 CYP2C19 Genotype|
697974|NCT01870388|O2|Outcome|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with moderate hepatic impairment as classified by Child-Pugh B.
697975|NCT01870388|O1|Outcome|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally to participants with normal hepatic function.
697976|NCT01870388|E2|Reported Event|Baricitinib (Moderate Hepatic Impairment)|Group 2: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with moderate hepatic impairment as classified by Child-Pugh B.
697977|NCT01870388|E1|Reported Event|Baricitinib (Healthy Participants)|Group 1: A single 4-mg dose of baricitinib (one 4-mg tablet) administered once, orally, to participants with normal hepatic function.
697978|NCT01869959|B5|Baseline|Total|Total of all reporting groups
697979|NCT01869959|B4|Baseline|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
697980|NCT01869959|B3|Baseline|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
697981|NCT01869959|B2|Baseline|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
697982|NCT01869959|B1|Baseline|3 mg LY2405319|3 mg LY2405319 injected SC once daily for 28 days.
697983|NCT01869959|P5|Participant Flow|All Randomized Participants|All participants randomized in the study.
697984|NCT01869959|P4|Participant Flow|Placebo|Placebo-matching LY2405319 injected subcutaneously (SC) once daily for 28 days.
697985|NCT01869959|P3|Participant Flow|20 mg LY2405319|20 mg LY2405319 injected SC once daily for 28 days.
697986|NCT01869959|P2|Participant Flow|10 mg LY2405319|10 mg LY2405319 injected SC once daily for 28 days.
697987|NCT01869959|P1|Participant Flow|3 mg LY2405319|3 milligrams (mg) LY2405319 injected SC once daily for 28 days.
697988|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
697995|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
697996|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
697997|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
697998|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
697999|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698000|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698001|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698002|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698003|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698004|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698005|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698006|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698007|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698008|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698009|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698010|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698011|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698012|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698013|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698014|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698015|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698016|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698017|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698018|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698019|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698020|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698021|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698022|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698023|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698024|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698025|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698026|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698027|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698028|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698029|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698030|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698031|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698032|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698033|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698034|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698035|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698036|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698037|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698038|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698039|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698040|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698041|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698042|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698043|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698044|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698045|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698046|NCT01869959|O4|Outcome|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698047|NCT01869959|O3|Outcome|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698048|NCT01869959|O2|Outcome|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698049|NCT01869959|O1|Outcome|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698050|NCT01869959|E4|Reported Event|Placebo|Participants received placebo-matching LY2405319 injected SC once daily for 28 days.
698051|NCT01869959|E3|Reported Event|20 mg LY2405319|Participants received 20 mg LY2405319 injected SC once daily for 28 days.
698052|NCT01869959|E2|Reported Event|10 mg LY2405319|Participants received 10 mg LY2405319 injected SC once daily for 28 days.
698053|NCT01869959|E1|Reported Event|3 mg LY2405319|Participants received 3 mg LY2405319 injected SC once daily for 28 days.
698054|NCT01869686|B1|Baseline|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698055|NCT01869686|P1|Participant Flow|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698056|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698057|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698058|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698059|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698060|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698061|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698062|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698063|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698064|NCT01869686|O1|Outcome|Denosumab|Participants received a single subcutaneous injection of 60 mg denosumab on Day 1.
698065|NCT01869686|E1|Reported Event|Denosumab 60 mg SC|
698066|NCT01869647|B4|Baseline|Total|Total of all reporting groups
698067|NCT01869647|B3|Baseline|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
698068|NCT01869647|B2|Baseline|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
698069|NCT01869647|B1|Baseline|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
698070|NCT01869647|P3|Participant Flow|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
698071|NCT01869647|P2|Participant Flow|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
698092|NCT01869478|E1|Reported Event|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
698093|NCT01869075|B7|Baseline|Total|Total of all reporting groups
698094|NCT01869075|B6|Baseline|HFS - Usual Care|Usual Care as provided at the hospital.
698072|NCT01869647|P1|Participant Flow|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
698073|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
698074|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
698075|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
698076|NCT01869647|O3|Outcome|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
701078|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
698077|NCT01869647|O2|Outcome|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
698078|NCT01869647|O1|Outcome|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
698079|NCT01869647|E3|Reported Event|"Low Likelihood of Stone Group"|"In the low likelihood of stone group the RA will present the data from the stone score to the physician and explain that patient is unlikely to have a kidney stone and they will be advised that probability of a stone is very low and that alternate imaging choices may be warranted. If they still choose to order a CT Flank Pain Protocol they will be asked to provide reasoning and the patient will receive a regular dose CT Flank Pain Protocol.~low likelihood of stone group: No imaging"
698080|NCT01869647|E2|Reported Event|"Moderate Likelihood of Stone Group"|"Subjects in the moderate likelihood of stone group will be given the option to receive either a standard dose CT or ULDCT. Again, the decision of which imaging option to choose will be made by the primary clinician in conjunction with the patient.~moderate likelihood of stone group: Regular CT or Low Dose CT scan"
698081|NCT01869647|E1|Reported Event|"High Likelihood of Stone Group"|"Subjects in the high likelihood of stone group will be eligible to get either ULDCT or expectant management. The choice will be determined by the primary clinician in conjunction with the patient. If ULDCT is elected, the scan will be read diagnostically by the radiologist and the clinician will treat the patient based on these results. If the expectant management option is chosen, no CT will be done during the ED visit and they will be treated as if they have a kidney stone.~high likelihood of stone group: Ultra low dose CT scan"
698082|NCT01869478|B3|Baseline|Total|Total of all reporting groups
698083|NCT01869478|B2|Baseline|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
698084|NCT01869478|B1|Baseline|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
698085|NCT01869478|P2|Participant Flow|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
698086|NCT01869478|P1|Participant Flow|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
698087|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
698088|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
698089|NCT01869478|O2|Outcome|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
698090|NCT01869478|O1|Outcome|Intravenous Thrombolysis|0.9mg/kg intravenous rt-PA (max dose 90mg) - 10% administered as a bolus over 1 minute and the remainder infused over 60 minutes.
698091|NCT01869478|E2|Reported Event|Endovascular Arterial Reperfusion|Therapeutic options will include mechanical thrombectomy/clot disruption (Penumbra aspiration system, Solitaire device, and/or Reflex catheter) and/or intracranial stent deployment.
698095|NCT01869075|B5|Baseline|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698096|NCT01869075|B4|Baseline|MGS - Usual Care|Usual Care as provided at the hospital.
698097|NCT01869075|B3|Baseline|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698098|NCT01869075|B2|Baseline|AMI - Usual Care|Usual care as provided at the hospital.
698099|NCT01869075|B1|Baseline|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698100|NCT01869075|P6|Participant Flow|HFS - Usual Care|Usual care provided at the hospital
698101|NCT01869075|P5|Participant Flow|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698102|NCT01869075|P4|Participant Flow|MGS - Usual Care|Usual care provided at the hospital
698135|NCT01868633|B2|Baseline|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
698103|NCT01869075|P3|Participant Flow|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698104|NCT01869075|P2|Participant Flow|AMI - Usual Care|Usual care provided at the hospital
698105|NCT01869075|P1|Participant Flow|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698106|NCT01869075|O6|Outcome|HFS - Usual Care|Usual Care as provided at the hospital
698107|NCT01869075|O5|Outcome|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698108|NCT01869075|O4|Outcome|MGS - Usual Care|Usual Care as provided at the hospital
698109|NCT01869075|O3|Outcome|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698110|NCT01869075|O2|Outcome|AMI - Usual Care|Usual care as provided at the hospital
698111|NCT01869075|O1|Outcome|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698112|NCT01869075|E6|Reported Event|HFS - Usual Care|Usual Care as provided at the hospital
698113|NCT01869075|E5|Reported Event|HFS - Knowledge Translation Toolkit|"Knowledge Translation Toolkit consists of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698114|NCT01869075|E4|Reported Event|MGS - Usual Care|Usual Care as provided at the hospital
698115|NCT01869075|E3|Reported Event|MGS - Knowledge Translation Toolkit|"Knowledge Translation toolkit involves use of pre-printed orders, audit and feedback, pharmacist as reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698116|NCT01869075|E2|Reported Event|AMI - Usual Care|Usual care as provided at the hospital
698117|NCT01869075|E1|Reported Event|AMI - Knowledge Translation Toolkit|"AMI - Knowledge Translation (KT) toolkit includes use of pre-printed orders, audit and feedback, pharmacist as a reminder and education of staff~Knowledge Translation (KT) toolkit: KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff"
698118|NCT01868893|B1|Baseline|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
698119|NCT01868893|P1|Participant Flow|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
698120|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
698121|NCT01868893|O1|Outcome|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
698122|NCT01868893|O2|Outcome|Chlorambucil|Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6.
698123|NCT01868893|O1|Outcome|Obinutuzumab|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6.
698124|NCT01868893|E1|Reported Event|Obinutuzumab + Chlorambucil|Obinutuzumab was administered intravenously for 6 cycles (28-day cycles) as: 100 mg on Day 1, 900 mg on Day 2, and 1000 mg on Days 8 and 15 for Cycle 1; and 1000 mg on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally at a dose of 0.5 mg/kg body weight on Days 1 and 15 for Cycles 1 through 6 (28-day cycles).
698125|NCT01868776|B3|Baseline|Total|Total of all reporting groups
698126|NCT01868776|B2|Baseline|Nonbuffered|nonbuffered lidocaine
698127|NCT01868776|B1|Baseline|Buffered|buffered lidocaine
698128|NCT01868776|P2|Participant Flow|Nonbuffered|nonbuffered lidocaine
698129|NCT01868776|P1|Participant Flow|Buffered|buffered lidocaine
698130|NCT01868776|O2|Outcome|Nonbuffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine~nonbuffered lidocaine"
698131|NCT01868776|O1|Outcome|Buffered Lidocaine|"4% lidocaine with 1:100,000 epinephrine/0.18 mEq/mL sodium bicarbonate.~buffered lidocaine"
698132|NCT01868776|E2|Reported Event|Nonbuffered|nonbuffered lidocaine
698133|NCT01868776|E1|Reported Event|Buffered|buffered lidocaine
698134|NCT01868633|B3|Baseline|Total|Total of all reporting groups
698175|NCT01868243|P2|Participant Flow|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
698136|NCT01868633|B1|Baseline|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
698137|NCT01868633|P2|Participant Flow|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
698138|NCT01868633|P1|Participant Flow|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
698139|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
698140|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
698141|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
698142|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
698143|NCT01868633|O2|Outcome|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
698144|NCT01868633|O1|Outcome|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
698145|NCT01868633|E2|Reported Event|Placebo Injection and Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 2ml of placebo (Normal saline) drawn to mimic active drug given intraoperatively~Placebo"
698146|NCT01868633|E1|Reported Event|Dexamethasone & Spinal Morphine|"intrathecal morphine administered at time of spinal anesthesia. After cesarean delivery 8mg (2ml) of Dexamethasone given intraoperatively~Dexamethasone"
698147|NCT01868542|B3|Baseline|Total|Total of all reporting groups
698148|NCT01868542|B2|Baseline|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698149|NCT01868542|B1|Baseline|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698199|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698200|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698150|NCT01868542|P2|Participant Flow|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698151|NCT01868542|P1|Participant Flow|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698152|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698176|NCT01868243|P1|Participant Flow|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
698177|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
698153|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698154|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698155|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698156|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698157|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698251|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698158|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698159|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698160|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698171|NCT01868503|E1|Reported Event|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
698172|NCT01868243|B3|Baseline|Total|Total of all reporting groups
698161|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698162|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698163|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
698164|NCT01868542|O2|Outcome|Insulin Detemir (2-4-6-8 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir.
698165|NCT01868542|O1|Outcome|Insulin Detemir (3-0-3 Algorithm )|A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done : >6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir.
733938|NCT01676298|E3|Reported Event|*2/*2 CYP2C19 Genotype|
698166|NCT01868542|E2|Reported Event|Insulin Detemir (2-4-6-8 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>10.0 mmol/L (180 mg/dL) +8U insulin detemir, 9.1-10.0 mmol/L (163-180 mg/dL) +6U insulin detemir, 8.1-9.0 mmol/L (145-162 mg/dL) +4 U insulin detemir, 7.1-8.0 mmol/L (127-144 mg/dL) +2U insulin detemir, 6.1-7.0 mmol/L (109-126 mg/dL) +2U insulin detemir, 4.1-6.0 mmol/L (73-108 mg/dL) No adjustment in insulin detemir, 3.1-4.0 mmol/L (56-72 mg/dL) -2U insulin detemir, <3.1 mmol/L (<56 mg/dL) -4U insulin detemir."
698167|NCT01868542|E1|Reported Event|Insulin Detemir (3-0-3 Algorithm )|"A once daily dosage of Insulin detemir (Levemir®) 100 U/mL 3 mL FlexPen® for subcutaneous administration was selected for this trial.During the treatment period insulin detemir was adjusted by the subject themselves (self-titration). Self-titration was performed every 3 days based on the lowest of three previous consecutive pre-breakfast SMPG values.Based on this glucose value, self-adjustment of insulin detemir dose was done. Metformin and Sulfonlylurea were allowed as OADs. For SMPG values , the following insulin detemir dose adjustments were done :~>6.1 mmol/L (>110 mg/dL) +3U insulin detemir, 4.4-6.1 mmol/L (80-100 mg/dL) No adjustment in insulin detemir, < 4.4 mmol/L (<80 mg/dL) -3U insulin detemir."
698168|NCT01868503|B1|Baseline|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
698169|NCT01868503|P1|Participant Flow|Treatment (Lapatinib Ditosylate, Radiation Therapy)|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
698170|NCT01868503|O1|Outcome|Lapatinib Plus Radiation Therapy|"Patients receive lapatinib ditosylate PO QD on day 1 until completion of radiation therapy. Beginning on day 7, patients undergo radiation therapy for 5-7 weeks and will have their blood banked for laboratory biomarker analysis.~lapatinib ditosylate: Given PO~radiation therapy: Undergo radiation therapy~laboratory biomarker analysis: Correlative studies"
698173|NCT01868243|B2|Baseline|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose"
698174|NCT01868243|B1|Baseline|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg (50 patients)"
698178|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
698179|NCT01868243|O2|Outcome|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
698180|NCT01868243|O1|Outcome|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
698181|NCT01868243|E2|Reported Event|Warfarin|"Warfarin adjusted-dose~Warfarin: Warfarin adjusted-dose (INR 2.0-3.0)"
698182|NCT01868243|E1|Reported Event|Dabigatran|"Dabigatran 110 mg BID~Dabigatran: Group 1 - Dabigatran 110 mg"
698183|NCT01868074|B3|Baseline|Total|Total of all reporting groups
698184|NCT01868074|B2|Baseline|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
698185|NCT01868074|B1|Baseline|Customized Insole|These participants were casted for customized insoles.
698186|NCT01868074|P2|Participant Flow|Usual Care Group|Participants in the control group were instructed to wear their usual footwear over the course of their pregnancy.
698187|NCT01868074|P1|Participant Flow|Customized Insole Group|Each participant in the intervention group had her insole customized to fit her typical daily footwear and was instructed to wear the insoles as often as possible. Participants in the intervention group had their feet molded by a certified orthotist, using a 3M, soft cast. The casting was done in a non-weight bearing, hind-foot neutral position so the insoles would preserve the long transverse arch and maintain a biomechanically efficient state to control motion at the foot and ankle. These castings were used to custom form insoles with the following characteristics: Footlights athletic or dress model (per participant shoe preference), with 3/16” semi-rigid shells, no arch fill, extrinsic rearfoot and standard intrinsic forefoot posting. A research team member not involved with outcome measurements met with the participants to give them their insoles and confirm they fit.
698188|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
698189|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
698190|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
698191|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
698192|NCT01868074|O2|Outcome|Usual Care Group|Participants in the control/usual group were instructed to wear their usual footwear over the course of their pregnancy.
698193|NCT01868074|O1|Outcome|Customized Insole Group|This intervention group were casted for customized insoles.
698194|NCT01868074|E2|Reported Event|Usual Care|Participants were instructed to wear their usual footwear over the course of their pregnancy.
698195|NCT01868074|E1|Reported Event|Customized Insole|These participants were casted for customized insoles.
698196|NCT01868035|B1|Baseline|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698197|NCT01868035|P1|Participant Flow|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698198|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698201|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698202|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698203|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698204|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698205|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698206|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698207|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698266|NCT01867307|O1|Outcome|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
698208|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698209|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698210|NCT01868035|O1|Outcome|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698211|NCT01868035|E1|Reported Event|TST/Iodine I-131 TST|Participants received an infusion of 450 milligrams (mg) of unlabeled Anti-B1 antibody of Tositumomab (TST) over the course of 60 minutes, followed by a 30 minute infusion (including a 10 minute flush) of 35 mg Anti-B1 antibody of TST labelled with 5 miillicuries (5 mCi) of Iodine-131.
698212|NCT01868009|B1|Baseline|DISKUS BID in Period 1 or 2; ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive one of the following two sequences of DPIs containing placebo: (1) DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2; (2) ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698213|NCT01868009|P2|Participant Flow|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698214|NCT01868009|P1|Participant Flow|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current chronic obstructive pulmonary disease (COPD) medication(s) were randomized to receive DISKUS twice a day (BID) for 5-9 days in Period 1 and ELLIPTA once a day (QD) for 5-9 days in Period 2. There was no washout period between the two periods. Neither dry powder inhaler (DPI) contained any active treatment; placebo was administered in both DPIs.
698215|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698216|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698217|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698218|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698219|NCT01868009|O2|Outcome|ELLIPTA QD in Period 1; DISKUS BID in Period 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in Period 1 and DISKUS BID for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698252|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698220|NCT01868009|O1|Outcome|DISKUS BID in Period 1; ELLIPTA QD in Period 2|Participants who were on their current COPD medication(s) were randomized to receive DISKUS BID for 5-9 days in Period 1 and ELLIPTA QD for 5-9 days in Period 2. There was no washout period between the two periods. Neither DPI contained any active treatment; placebo was administered in both DPIs.
698221|NCT01868009|E2|Reported Event|DISKUS BID in Period 1 or 2|Subjects will use the DISKUS inhaler twice daily for 5 to 9 days during the first period followed by the ELLIPTA inhaler once daily for 5 to 9 days during the second period.
698222|NCT01868009|E1|Reported Event|ELLIPTA QD in Period 1 or 2|Participants who were on their current COPD medication(s) were randomized to receive ELLIPTA QD for 5-9 days in either Period 1 or Period 2. There was no washout period between the two periods. The DPI did not contain any active treatment; placebo was administered in the DPI.
698223|NCT01867710|B5|Baseline|Total|Total of all reporting groups
698224|NCT01867710|B4|Baseline|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
698225|NCT01867710|B3|Baseline|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
698226|NCT01867710|B2|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
698227|NCT01867710|B1|Baseline|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
698228|NCT01867710|P4|Participant Flow|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
698229|NCT01867710|P3|Participant Flow|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
698230|NCT01867710|P2|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
698306|NCT01867021|E2|Reported Event|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
698231|NCT01867710|P1|Participant Flow|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
698232|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
698233|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
698234|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
698235|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
698236|NCT01867710|O4|Outcome|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
698237|NCT01867710|O3|Outcome|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
698238|NCT01867710|O2|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
698239|NCT01867710|O1|Outcome|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
698240|NCT01867710|E4|Reported Event|Abiraterone Acetate 1000milligram(mg)QD+Dexamethasone 0.5mg QD|Participants received abiraterone acetate 1000 mg and dexamethasone 0.5 mg tablet orally once daily up to 156 Weeks.
698241|NCT01867710|E3|Reported Event|Abiraterone Acetate 1000 Milligram(mg) QD+Prednisone 2.5mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 2.5 mg tablet orally twice daily up to 156 Weeks.
698242|NCT01867710|E2|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg QD|Participants received abiraterone acetate 1000 mg and prednisone 5 mg tablet orally once daily up to 156 Weeks.
698243|NCT01867710|E1|Reported Event|Abiraterone Acetate 1000 Milligram (mg) QD+Prednisone 5 mg BID|Participants received abiraterone acetate 1000 mg tablet orally once daily and prednisone 5 mg tablet orally twice daily up to 156 Weeks.
698244|NCT01867658|B1|Baseline|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698245|NCT01867658|P1|Participant Flow|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698246|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698247|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698248|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698249|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698250|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698319|NCT01866319|B4|Baseline|Total|Total of all reporting groups
698253|NCT01867658|O1|Outcome|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698254|NCT01867658|E1|Reported Event|Progel® Pleural Air Leak Sealant|Progel® Pleural Air Leak Sealant: Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
698255|NCT01867632|B1|Baseline|Acellular Dermal Matrix|"A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.~Acellular Dermal Matrix"
698256|NCT01867632|P1|Participant Flow|Acellular Dermal Matrix|"A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.~Acellular Dermal Matrix"
698257|NCT01867632|O1|Outcome|Acellular Dermal Matrix|"A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.~Acellular Dermal Matrix"
698258|NCT01867632|O1|Outcome|Acellular Dermal Matrix|Patients who had palatal fistula repair reinforced by small piece of ADM between oral and muscle layers.
698259|NCT01867632|E1|Reported Event|Acellular Dermal Matrix|"A tailored piece of Acellular Dermal Matrix will be placed between the oral and nasal layers at the time of a Furlow Palatoplasty for repair of a Cleft Palate.~Acellular Dermal Matrix"
698260|NCT01867307|B3|Baseline|Total|Total of all reporting groups
698261|NCT01867307|B2|Baseline|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
698262|NCT01867307|B1|Baseline|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
698263|NCT01867307|P2|Participant Flow|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
698264|NCT01867307|P1|Participant Flow|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
698265|NCT01867307|O2|Outcome|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
698267|NCT01867307|E2|Reported Event|Healthy Subjects|Oral administration of empagliflozin (25 mg once daily) in healthy subjects for 14 days
698268|NCT01867307|E1|Reported Event|T2DM Patients|Oral administration of empagliflozin (25 mg once daily) in patients with type 2 diabetes mellitus for 14 days
698269|NCT01867164|B3|Baseline|Total|Total of all reporting groups
698270|NCT01867164|B2|Baseline|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
698271|NCT01867164|B1|Baseline|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698272|NCT01867164|P2|Participant Flow|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter (mcg/ml) nystatin was administered vaginally, every 24 hours at night, for 10 days.
698273|NCT01867164|P1|Participant Flow|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698274|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
698275|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698276|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
698277|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698278|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
698279|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698280|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
698281|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698282|NCT01867164|O2|Outcome|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
698283|NCT01867164|O1|Outcome|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698284|NCT01867164|E2|Reported Event|Vagitrol V (Metronidazole+Fluocinolone Acetonide+Nystatin)|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 mcg/ml nystatin was administered vaginally, every 24 hours at night, for 10 days.
698285|NCT01867164|E1|Reported Event|Gynoclin V (Terconazole+Clindamycin+Fluocinolone Acetonide)|One ovule containing 80 mg terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide was administered vaginally, every 24 hours at night, for 3 days.
698286|NCT01867021|B3|Baseline|Total|Total of all reporting groups
698287|NCT01867021|B2|Baseline|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
698288|NCT01867021|B1|Baseline|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
698289|NCT01867021|P2|Participant Flow|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
698290|NCT01867021|P1|Participant Flow|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
698291|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
698292|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
698293|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
698294|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
698295|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
698296|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
698297|NCT01867021|O4|Outcome|≥65 years_Fluvirin|Subjects ≥65 years of age who received a control vaccine TIVf
698298|NCT01867021|O3|Outcome|≥65 years_Agriflu|Subjects ≥65 years of age who received an investigational vaccine TIV
698299|NCT01867021|O2|Outcome|≥50 to ≤64 years_Fluvirin|Subjects ≥50 to ≤64 years of age who received a control vaccine TIVf
698300|NCT01867021|O1|Outcome|≥50 to ≤64 years_Agriflu|Subjects ≥50 to ≤64 years of age who received an investigational vaccine TIV
698301|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
698302|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
698303|NCT01867021|O2|Outcome|Fluvirin|Subjects ≥50 years of age who received one vaccination of a control vaccine TIVf
698304|NCT01867021|O1|Outcome|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
698305|NCT01867021|E3|Reported Event|Total|Total number of Subjects
698307|NCT01867021|E1|Reported Event|Agriflu|Subjects ≥50 years of age who received one vaccination of an investigational vaccine TIV
698308|NCT01866709|B3|Baseline|Total|Total of all reporting groups
698309|NCT01866709|B2|Baseline|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention (give reasons) (n= 0)~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 17): study terminated early due to safety reasons"
698310|NCT01866709|B1|Baseline|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE)~Total Study Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Total Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analysed (n= 0)~◻ Excluded from analysis (give reasons) (n= 15): study terminated early due to safety reasons"
698311|NCT01866709|P2|Participant Flow|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 17): PLACEBO~Received allocated intervention (n= 17 )~Did not receive allocated intervention (give reasons) (n= 0)~Lost to follow-up (give reasons) (n= 0 )~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
698312|NCT01866709|P1|Participant Flow|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Enrollment: Assessed for eligibility (n= 36 )~Excluded (n= 4)~Not meeting inclusion criteria (n= 4 )~Declined to participate (n= 0)~Other reasons (n= 0 )~Randomized (n= 32 )~Allocated to intervention (n= 15 ): ACTIVE~Received allocated intervention (n= 15)~Did not receive allocated intervention (give reasons) (n= 0 )~Lost to follow-up (give reasons) (n= 0 )~Discontinued intervention before study terminated (n= 1): non-serious adverse event~Analyzed (n= 0)~◻ Excluded from analysis (give reasons) (n= 32 study terminated early due to safety reasons)"
698313|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose"
698314|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate"
698315|NCT01866709|O2|Outcome|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose"
698316|NCT01866709|O1|Outcome|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate"
698317|NCT01866709|E2|Reported Event|Silicified Microcrystalline Cellulose|"Oral suspension of placebo blended with pigment to have the same appearance, taste, odor and mode of administration as SPS.~Silicified microcrystalline cellulose (PLACEBO): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
698318|NCT01866709|E1|Reported Event|Sodium Polystyrene Sulfonate|"Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.~Sodium polystyrene sulfonate (ACTIVE): Participants were solicited for adverse events at each study visit (i.e. Days 1, 2 and 9) by systematic regular investigator assessment."
698320|NCT01866319|B3|Baseline|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
698321|NCT01866319|B2|Baseline|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
698322|NCT01866319|B1|Baseline|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
698323|NCT01866319|P3|Participant Flow|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
698324|NCT01866319|P2|Participant Flow|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, once every 2 weeks (Q2W) for up to 2 years
698325|NCT01866319|P1|Participant Flow|Ipilimumab|Participants receive ipilimumab, 3 mg/kg intravenously (IV), once eveery 3 weeks (Q3W) for a total of 4 doses
698326|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
698327|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
698328|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
698329|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
698330|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
698331|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
698332|NCT01866319|O3|Outcome|Pembrolizumab Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
698333|NCT01866319|O2|Outcome|Pembrolizumab Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
698334|NCT01866319|O1|Outcome|Ipilimumab|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
698335|NCT01866319|E3|Reported Event|Pembrolizumab 10 mg/kg Q3W|Participants receive pembrolizumab, 10 mg/kg IV, Q3W for up to 2 years
698336|NCT01866319|E2|Reported Event|Pembrolizumab 10 mg/kg Q2W|Participants receive pembrolizumab, 10 mg/kg IV, Q2W for up to 2 years
698337|NCT01866319|E1|Reported Event|Ipilimumab 3 mg/kg Q3W|Participants receive ipilimumab, 3 mg/kg IV, Q3W for a total of 4 doses
698338|NCT01866306|B8|Baseline|Total|Total of all reporting groups
698339|NCT01866306|B7|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698340|NCT01866306|B6|Baseline|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698341|NCT01866306|B5|Baseline|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698342|NCT01866306|B4|Baseline|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698343|NCT01866306|B3|Baseline|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698344|NCT01866306|B2|Baseline|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698345|NCT01866306|B1|Baseline|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698346|NCT01866306|P7|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698347|NCT01866306|P6|Participant Flow|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698348|NCT01866306|P5|Participant Flow|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698349|NCT01866306|P4|Participant Flow|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698350|NCT01866306|P3|Participant Flow|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698351|NCT01866306|P2|Participant Flow|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698352|NCT01866306|P1|Participant Flow|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698353|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698354|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698355|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698356|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698357|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698358|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698359|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698360|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698361|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698362|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698363|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698364|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698365|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698366|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698429|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
698367|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698368|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698369|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698370|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698371|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698372|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698373|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698374|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698375|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698376|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698377|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698378|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698379|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698380|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698381|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698382|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698383|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698384|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698385|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698386|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698487|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
698387|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698388|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698389|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698390|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698391|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698392|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698393|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698394|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698395|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698430|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
701079|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
698396|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698397|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698398|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698399|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698400|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698401|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698402|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698403|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698404|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698405|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698406|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698407|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698408|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698409|NCT01866306|O7|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698410|NCT01866306|O6|Outcome|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698411|NCT01866306|O5|Outcome|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698412|NCT01866306|O4|Outcome|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698413|NCT01866306|O3|Outcome|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698414|NCT01866306|O2|Outcome|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698415|NCT01866306|O1|Outcome|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698416|NCT01866306|E7|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 2)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698417|NCT01866306|E6|Reported Event|Asthmatic LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698418|NCT01866306|E5|Reported Event|Asthmatic Non-LABA 100 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698419|NCT01866306|E4|Reported Event|Asthmatic Non-LABA 10 TCID50 (Part 1)|Participants with mild to moderate asthma, not concomitantly treated with LABA, were treated with 10 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698420|NCT01866306|E3|Reported Event|Healthy 1000 TCID50 (Part 1)|Healthy participants were treated with 1000 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698421|NCT01866306|E2|Reported Event|Healthy 100 TCID50 (Part 1)|Healthy participants were treated with 100 TCID50 administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698422|NCT01866306|E1|Reported Event|Healthy 10 TCID50 (Part 1)|Healthy participants were treated with 10 Tissue Culture Infective Dose 50 (TCID50) administered by spraying an atomized viral suspension of RV16UB into a single nostril.
698423|NCT01866163|B3|Baseline|Total|Total of all reporting groups
698424|NCT01866163|B2|Baseline|Vehicle|Aerosol foam vehicle
698425|NCT01866163|B1|Baseline|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
698426|NCT01866163|P2|Participant Flow|Vehicle|Aerosol foam vehicle
698427|NCT01866163|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
698428|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
698431|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
698432|NCT01866163|O2|Outcome|Vehicle|Aerosol foam vehicle
698433|NCT01866163|O1|Outcome|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
698434|NCT01866163|E2|Reported Event|Vehicle|Aerosol foam vehicle
698435|NCT01866163|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam, containing calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
698436|NCT01866150|B1|Baseline|Overall Population|Retrospective chart review of all participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to NICE guidelines. Biologic combination therapy included biologic drug therapy (any) plus MTX or biologic plus MTX plus any other and classical DMARDs.
698437|NCT01866150|P1|Participant Flow|Overall Population|Retrospective chart review of all participants with rheumatoid arthritis (RA) who were being treated with first-line biologic drug therapy (any) as monotherapy or biologic combination therapy according to National Institute for Health and Care Excellence (NICE) guidelines. Biologic combination therapy included biologic drug therapy (any) plus methotrexate (MTX) or biologic plus MTX plus any other and classical disease-modifying antirheumatic drugs (DMARDs).
698438|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698439|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698440|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698441|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698442|NCT01866150|O1|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698443|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698444|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698445|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698446|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698447|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698448|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698449|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698450|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698451|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698452|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698453|NCT01866150|O2|Outcome|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698454|NCT01866150|O1|Outcome|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (any) as monotherapy according to NICE guidelines.
698455|NCT01866150|E2|Reported Event|Biologic Combination|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) plus MTX or biologic plus MTX plus any other classical DMARDs according to NICE guidelines.
698456|NCT01866150|E1|Reported Event|Biologic Monotherapy|Retrospective chart review of participants with RA who were being treated with first-line biologic drug therapy (only rituximab or tocilizumab) as monotherapy according to NICE guidelines.
698457|NCT01865812|B1|Baseline|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
698458|NCT01865812|P1|Participant Flow|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
698459|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
698460|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
698461|NCT01865812|O1|Outcome|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
698462|NCT01865812|E1|Reported Event|OCA: 10 mg|"obeticholic acid, oral administration, 10 mg, 8 weeks~obeticholic acid (OCA): All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years."
698463|NCT01865084|B4|Baseline|Total|Total of all reporting groups
698464|NCT01865084|B3|Baseline|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
698465|NCT01865084|B2|Baseline|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
698466|NCT01865084|B1|Baseline|Placebo|Placebo taken orally once daily.
698467|NCT01865084|P3|Participant Flow|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
698468|NCT01865084|P2|Participant Flow|0.3 mg/kg Tadalafil|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
698469|NCT01865084|P1|Participant Flow|Placebo|Placebo taken orally once daily.
698470|NCT01865084|O1|Outcome|0.3 mg/kg Tadalafil and 0.6 mg/kg Tadalafil|"0.3 mg/kg tadalafil taken orally once daily.~0.6 mg/kg tadalafil taken orally once daily."
698471|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
698472|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
698473|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
698474|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
698475|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
698476|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
698477|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
698478|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
698479|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
698480|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
698481|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
698482|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
698483|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg tadalafil taken orally once daily.
698484|NCT01865084|O2|Outcome|0.3 mg/kg Tadalafil|0.3 mg/kg tadalafil taken orally once daily.
698485|NCT01865084|O1|Outcome|Placebo|Placebo taken orally once daily.
698486|NCT01865084|O3|Outcome|0.6 mg/kg Tadalafil|0.6 mg/kg taken tadalafil orally once daily.
698489|NCT01865084|E5|Reported Event|0.6 mg/kg Tadalafil - OLE|0.6 mg/kg tadalafil taken orally once daily.
698490|NCT01865084|E4|Reported Event|0.3 mg/kg Tadalafil - OLE|0.3 mg/kg tadalafil taken orally once daily.
698491|NCT01865084|E3|Reported Event|0.6 mg/kg Tadalafil - DB|0.6 mg/kg tadalafil taken orally once daily.
698492|NCT01865084|E2|Reported Event|0.3 mg/kg Tadalafil -DB|0.3 milligram per kilogram (mg/kg) tadalafil taken orally once daily.
698493|NCT01865084|E1|Reported Event|Placebo - DB|Placebo taken orally once daily.
698494|NCT01864434|B3|Baseline|Total|Total of all reporting groups
698495|NCT01864434|B2|Baseline|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
698496|NCT01864434|B1|Baseline|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
698497|NCT01864434|P2|Participant Flow|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
698498|NCT01864434|P1|Participant Flow|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
698499|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
698500|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
698501|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
698502|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
698503|NCT01864434|O2|Outcome|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
698504|NCT01864434|O1|Outcome|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
698505|NCT01864434|E2|Reported Event|Patients With a Zimmer PCR TKA|"Patients implanted with a Zimmer Poster Cruciate Retaining Total Knee Arthroplasty.~Zimmer PCR TKA"
698506|NCT01864434|E1|Reported Event|Patients With a Stryker Triathlon CR TKA|"Patients implanted with a Stryker Triathlon Cruciate Retaining Total Knee Arthroplasty.~Stryker PCR TKA"
698507|NCT01864148|B6|Baseline|Total|Total of all reporting groups
698508|NCT01864148|B5|Baseline|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698509|NCT01864148|B4|Baseline|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698510|NCT01864148|B3|Baseline|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698511|NCT01864148|B2|Baseline|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698512|NCT01864148|B1|Baseline|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698513|NCT01864148|P5|Participant Flow|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698514|NCT01864148|P4|Participant Flow|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698515|NCT01864148|P3|Participant Flow|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698516|NCT01864148|P2|Participant Flow|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698517|NCT01864148|P1|Participant Flow|Placebo|"Placebo once every 4 weeks intravenous (IV) infusion up to Week 72.~Avonex once-weekly intramuscular (IM) injection up to Week 84."
698518|NCT01864148|O4|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698519|NCT01864148|O3|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698520|NCT01864148|O2|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698521|NCT01864148|O1|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698522|NCT01864148|O6|Outcome|BIIB033 Total|BIIB033 3, 10, 30, or 100 mg/kg once every 4 weeks IV infusion
698523|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698524|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698525|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698526|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698527|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698528|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698529|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698530|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698531|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698532|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698533|NCT01864148|O5|Outcome|BIIB033, 100 mg/kg|"BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
733939|NCT01676298|E2|Reported Event|*1/*2 CYP2C19 Genotype|
698534|NCT01864148|O4|Outcome|BIIB033, 30 mg/kg|"BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698535|NCT01864148|O3|Outcome|BIIB033, 10 mg/kg|"BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698536|NCT01864148|O2|Outcome|BIIB033, 3 mg/kg|"BIIB033 3 mg/kg once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698537|NCT01864148|O1|Outcome|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698538|NCT01864148|E5|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg once every 4 weeks IV infusion
698539|NCT01864148|E4|Reported Event|BIIB033 30 mg/kg|BIIB033 30 mg/kg once every 4 weeks IV infusion
698540|NCT01864148|E3|Reported Event|BIIB033 10 mg/kg|BIIB033 10 mg/kg once every 4 weeks IV infusion
698541|NCT01864148|E2|Reported Event|BIIB033 3 mg/kg|BIIB033 3 mg/kg once every 4 weeks IV infusion
698542|NCT01864148|E1|Reported Event|Placebo|"Placebo once every 4 weeks IV infusion up to Week 72.~Avonex once-weekly IM injection up to Week 84."
698543|NCT01864005|B3|Baseline|Total|Total of all reporting groups
698544|NCT01864005|B2|Baseline|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698545|NCT01864005|B1|Baseline|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698546|NCT01864005|P2|Participant Flow|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698547|NCT01864005|P1|Participant Flow|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698548|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698549|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698550|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698551|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698552|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698553|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698554|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698555|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698556|NCT01864005|O2|Outcome|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698557|NCT01864005|O1|Outcome|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698558|NCT01864005|E2|Reported Event|Clopidogrel|Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
698612|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698559|NCT01864005|E1|Reported Event|Ticagrelor|Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
698560|NCT01863953|B4|Baseline|Total|Total of all reporting groups
698561|NCT01863953|B3|Baseline|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
698562|NCT01863953|B2|Baseline|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
698563|NCT01863953|B1|Baseline|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
698564|NCT01863953|P3|Participant Flow|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
698565|NCT01863953|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
698566|NCT01863953|P1|Participant Flow|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
698567|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
698568|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
698569|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
698570|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
698571|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
698572|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
698573|NCT01863953|O3|Outcome|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
698574|NCT01863953|O2|Outcome|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
698575|NCT01863953|O1|Outcome|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
698576|NCT01863953|E3|Reported Event|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
698577|NCT01863953|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.01% and Vehicle|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening and vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
698578|NCT01863953|E1|Reported Event|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
698579|NCT01863771|B1|Baseline|All Participants|Participants who received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC) in the induction phase.
698580|NCT01863771|P4|Participant Flow|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 weeks through Week 52.
698581|NCT01863771|P3|Participant Flow|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
698582|NCT01863771|P2|Participant Flow|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
698583|NCT01863771|P1|Participant Flow|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
698584|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
698585|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
698586|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
698587|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
698588|NCT01863771|O2|Outcome|Golimumab|Participants received golimumab 200 mg (once at Week 0) and golimumab 100 mg (once at Week 2) SC in induction phase. Participants who responded to golimumab induction treatment received golimumab 100 mg SC, q4w through Week 52 and participants who not responded to golimumab induction treatment received golimumab 100 mg SC at Weeks 0 and 4, and based on clinical response every 4 weeks through Week 52 in maintenance phase.
698589|NCT01863771|O1|Outcome|Placebo|Participants who responded to golimumab induction treatment received placebo subcutaneously (SC) every 4 weeks (q4w) through Week 52 in the maintenance phase.
698613|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698590|NCT01863771|E4|Reported Event|Group 4: Golimumab 100 mg [Maintenance]|Participants who not responded to golimumab induction dosing received golimumab 100 mg SC once at Week 0 and once at Week 4, and based on clinical response every 4 week through Week 52.
698591|NCT01863771|E3|Reported Event|Group 3: Placebo [Maintenance]|Participants who responded to golimumab induction treatment received placebo SC every 4 weeks (q4w) through Week 52.
698592|NCT01863771|E2|Reported Event|Group 2: Golimumab 100 mg [Maintenance]|Participants who responded to golimumab induction treatment received golimumab 100 mg SC every 4 weeks (q4w) through Week 52.
698593|NCT01863771|E1|Reported Event|Group1: Golimumab [Induction]|Participants received golimumab 200 milligram (mg) once at Week 0 and golimumab 100 mg once at Week 2 subcutaneously (SC).
698594|NCT01863680|B1|Baseline|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro fertilization and embryo transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
698595|NCT01863680|P1|Participant Flow|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using Gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
698624|NCT01863433|P1|Participant Flow|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698596|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
698597|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
698598|NCT01863680|O1|Outcome|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
698599|NCT01863680|E1|Reported Event|COL-1620|"The subjects were administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8% gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12 or until the confirmation of miscarriage or extra-uterine pregnancy, or a negative pregnancy test whichever was earlier.~Subjects had undergone conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation, follicle-stimulating hormone (FSH) or human chorionic gonadotropin (hCG)."
698600|NCT01863667|B3|Baseline|Total|Total of all reporting groups
698601|NCT01863667|B2|Baseline|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698602|NCT01863667|B1|Baseline|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698603|NCT01863667|P2|Participant Flow|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698604|NCT01863667|P1|Participant Flow|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698605|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698606|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698607|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698608|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698609|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698610|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698611|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698614|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698615|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698616|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698617|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698618|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698619|NCT01863667|O2|Outcome|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698620|NCT01863667|O1|Outcome|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698621|NCT01863667|E2|Reported Event|Glimepiride|Participants received glimepiride 1 mg and/or 2 mg tablet(s) (maximum dose 6 mg/day) once daily and an omarigliptin placebo capsule once weekly, for 54 weeks.
698622|NCT01863667|E1|Reported Event|Omarigliptin|Participants received an omarigliptin (MK-3102) 25 mg capsule once weekly and glimepiride placebo tablet(s) once daily, for 54 weeks.
698623|NCT01863433|B1|Baseline|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698625|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698626|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698627|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698628|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698629|NCT01863433|O1|Outcome|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698630|NCT01863433|E1|Reported Event|Trivalent Influenza Vaccine|Healthy volunteers aged between 18 and 60 years received a single 0.5 mL dose of Trivalent Influenza Vaccine by intramuscular or subcutaneous injection.
698631|NCT01863368|B3|Baseline|Total|Total of all reporting groups
698632|NCT01863368|B2|Baseline|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698633|NCT01863368|B1|Baseline|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698634|NCT01863368|P2|Participant Flow|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698635|NCT01863368|P1|Participant Flow|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698636|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698637|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698638|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698639|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698640|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698641|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698642|NCT01863368|O2|Outcome|Optive|Lubricating eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698643|NCT01863368|O1|Outcome|Systane Ultra|Lubricant eyedrops, 1 drop in each eye 4 times a day for 35 days (Phase I), followed by 55 days additional use as needed (Phase II).
698644|NCT01863368|E3|Reported Event|Optive|All subjects who were exposed to Optive or run-in therapy
698645|NCT01863368|E2|Reported Event|Systane Ultra|All subjects who were exposed to Systane Ultra or run-in therapy
698646|NCT01863368|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to exposure to investigational product
698647|NCT01863134|B3|Baseline|Total|Total of all reporting groups
698648|NCT01863134|B2|Baseline|Eptifibatide|In the treatment group patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery). The minimal and maximal periods of eptifibatide infusion were established at 12 and 48 hours respectively.
698649|NCT01863134|B1|Baseline|Placebo/Control Group|In the control group patients were given identical doses of acetylsalicylic acid and enoxaparin followed by a placebo infusion of saline in lieu of the GPIIb/IIIa inhibitor.
698650|NCT01863134|P2|Participant Flow|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
698688|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
698651|NCT01863134|P1|Participant Flow|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
698652|NCT01863134|O2|Outcome|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
698653|NCT01863134|O1|Outcome|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
698654|NCT01863134|E2|Reported Event|Placebo|Patients were given placebo infusion (0,9% Natrium Chloride) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
698655|NCT01863134|E1|Reported Event|Eptifibatide|Patients were given a bolus of eptifibatide (Integrillin; 180µg/kg of body weight) and an intravenous infusion of 2 µg/kg/min followed by acetylsalicylic acid (150mg PO daily until the day of the procedure) and enoxaparin (1mg/kg SC - with the last dose 12 hours before surgery).
698656|NCT01862991|B4|Baseline|Total|Total of all reporting groups
698657|NCT01862991|B3|Baseline|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698658|NCT01862991|B2|Baseline|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698659|NCT01862991|B1|Baseline|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
698660|NCT01862991|P3|Participant Flow|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698661|NCT01862991|P2|Participant Flow|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698662|NCT01862991|P1|Participant Flow|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
698663|NCT01862991|O3|Outcome|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698664|NCT01862991|O2|Outcome|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698665|NCT01862991|O1|Outcome|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
698689|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
698690|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
698666|NCT01862991|O3|Outcome|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698667|NCT01862991|O2|Outcome|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698668|NCT01862991|O1|Outcome|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
698669|NCT01862991|E3|Reported Event|Mifepristone|"The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698739|NCT01861704|P2|Participant Flow|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
698740|NCT01861704|P1|Participant Flow|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
698670|NCT01862991|E2|Reported Event|Dilapan-Mifepristone|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S) (4mm x 65mm). The patient will be administered mifepristone (200mg) orally with juice or water by the clinician or study investigator.Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation~Mifepristone: 200 mcg Mifepristone orally"
698671|NCT01862991|E1|Reported Event|Dilapan-Placebo|"The clinician will place 4 or 5 osmotic cervical dilators (Dilapan-S)(4mm x 65mm). The patient will be administered a placebo pill orally with juice or water by the clinician or study investigator. Patients that are over 22 weeks gestation will receive 1mg of intra-amniotic digoxin the day prior to the procedure.~Hygroscopic cervical dilators: Dilapan-S osmotic cervical dilators inserted through the internal os.~Misoprostol: 400 mcg buccal misoprostol 90 pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation"
698672|NCT01862484|B3|Baseline|Total|Total of all reporting groups
698673|NCT01862484|B2|Baseline|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
698674|NCT01862484|B1|Baseline|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
698675|NCT01862484|P2|Participant Flow|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
698676|NCT01862484|P1|Participant Flow|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
698677|NCT01862484|O2|Outcome|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
698678|NCT01862484|O1|Outcome|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
698679|NCT01862484|E2|Reported Event|Ruse Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet.~Ruse Diet: Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet"
698680|NCT01862484|E1|Reported Event|Restricted Diet|"Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.~Restricted Diet: Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet."
698681|NCT01862419|B3|Baseline|Total|Total of all reporting groups
698682|NCT01862419|B2|Baseline|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
698683|NCT01862419|B1|Baseline|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
698684|NCT01862419|P2|Participant Flow|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
698685|NCT01862419|P1|Participant Flow|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
698686|NCT01862419|O2|Outcome|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
698687|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
733940|NCT01676298|E1|Reported Event|*1/*1 CYP2C19 Genotype|
698691|NCT01862419|O1|Outcome|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
698692|NCT01862419|E2|Reported Event|Usual Care|Usual care arm. No alert will be provided to the patient's covering provider or unit pharmacist.
698693|NCT01862419|E1|Reported Event|Alert|Text page sent to patient's covering provider and unit pharmacist informing them of the presence of AKI as detected by changes in serum creatinine.
698694|NCT01862133|B1|Baseline|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
698695|NCT01862133|P2|Participant Flow|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study"
698741|NCT01861704|O2|Outcome|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
698696|NCT01862133|P1|Participant Flow|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
698697|NCT01862133|O2|Outcome|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.~11 physicians and 23 additional clinic staff (5 nurses, 4 clinical nurse assistants, 3 physicians' assistants, 2 nurse practitioners, and 9 medical assistance worked in the study primary care clinic at the time of the study~2 physicians were excluded because their patients were mainly Spanish speaking~1 physician verbally agreed to be in the study but never signed the informed consent statement~8 physicians and all 23 of the other clinic staff were enrolled and signed informed consent statements and completed in the study~24"
698698|NCT01862133|O1|Outcome|Patient Preferences|"Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.~141 adult primary care clinic patients were approached 38 refused to participate 107 were enrolled and signed informed consent statements 2 failed to complete the patient preference dialog and study questionnaire 105 completed the patient preference dialog and were included in the study 92 subjects returned to the clinic during the 6-month study"
698699|NCT01862133|E2|Reported Event|Primary Care Providers|"All healthcare providers (physicians, nurses, and other clinic staff) were eligible to participate in this study. For those enrolled, display of patient data in the EMR was dictated by the patient subject's preferences for who should see what data.~Patient preferences: Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences."
698700|NCT01862133|E1|Reported Event|Patient Preferences|Patients were eligible if they had visited their primary care physician at least twice in the previous 1 year and were fluent in English. Each patient subject used an online program to record their preferences what each of their providers can see. The electronic medical record (EMR) will then apply them to data displays.
698701|NCT01861925|B4|Baseline|Total|Total of all reporting groups
698702|NCT01861925|B3|Baseline|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698703|NCT01861925|B2|Baseline|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698704|NCT01861925|B1|Baseline|Normal Eye|Astigmatism smaller than 1.5 diopters
698705|NCT01861925|P3|Participant Flow|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698706|NCT01861925|P2|Participant Flow|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698707|NCT01861925|P1|Participant Flow|Normal Eye|Astigmatism smaller than 1.5 diopters
698708|NCT01861925|O1|Outcome|Regular Eye|"Astigmatism smaller than 1.5 diopters and regular astigmatism >= 1.5 diopters (group normal eye and large regular astigmatism)"
698709|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698710|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698711|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
698712|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698713|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698714|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
698715|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698716|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698717|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
733941|NCT01676220|B3|Baseline|Total|Total of all reporting groups
698718|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698719|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698720|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
698721|NCT01861925|O3|Outcome|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698722|NCT01861925|O2|Outcome|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698723|NCT01861925|O1|Outcome|Normal Eye|Astigmatism smaller than 1.5 diopters
698724|NCT01861925|E3|Reported Event|Large Irregular Astigmatism|Astigmatism of > 1.5 diopters, irregular astigmatism.
698725|NCT01861925|E2|Reported Event|Large Regular Astigmatism|Astigmatism of > 1.5 diopters, regular astigmatism.
698726|NCT01861925|E1|Reported Event|Normal Eye|Astigmatism smaller than 1.5 diopters
698727|NCT01861756|B3|Baseline|Total|Total of all reporting groups
698728|NCT01861756|B2|Baseline|Usual Care|
698729|NCT01861756|B1|Baseline|Diabetes Medication Choice Decision Aid|
698730|NCT01861756|P2|Participant Flow|Usual Care|
698731|NCT01861756|P1|Participant Flow|Diabetes Medication Choice Decision Aid|
698732|NCT01861756|O2|Outcome|Usual Care|
698733|NCT01861756|O1|Outcome|Diabetes Medication Choice Decision Aid|
698734|NCT01861756|E2|Reported Event|Usual Care|
698735|NCT01861756|E1|Reported Event|Diabetes Medication Choice Decision Aid|
698736|NCT01861704|B3|Baseline|Total|Total of all reporting groups
698737|NCT01861704|B2|Baseline|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
698738|NCT01861704|B1|Baseline|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
698742|NCT01861704|O1|Outcome|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument~Only experienced ears counted"
698743|NCT01861704|E2|Reported Event|Lyric2|"Lyric2 (Barracuda) device~Lyric: Extended wear hearing instrument"
698744|NCT01861704|E1|Reported Event|Lyric|"Silver Lyric device~Lyric: Extended wear hearing instrument"
698745|NCT01861522|B3|Baseline|Total|Total of all reporting groups
698746|NCT01861522|B2|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
698747|NCT01861522|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
698748|NCT01861522|P2|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
698749|NCT01861522|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
698750|NCT01861522|O2|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
698751|NCT01861522|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
698752|NCT01861522|E2|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
698753|NCT01861522|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
698754|NCT01861457|B3|Baseline|Total|Total of all reporting groups
698755|NCT01861457|B2|Baseline|Saline Placebo|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Placebo"
698756|NCT01861457|B1|Baseline|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril 3x in a 10-hour study period.~Nozin Nasal Sanitizer"
698757|NCT01861457|P2|Participant Flow|Phosphate-buffered Saline (PBS) Placebo|Participants undergo three nasal vestibular applications of the PBS placebo using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
698758|NCT01861457|P1|Participant Flow|Nozin® Nasal Sanitizer®|Participants undergo three nasal vestibular applications of the alcohol-based antiseptic using a saturated nasal swab at 4-hour intervals during the 10-hour study period.
698759|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
698760|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
698761|NCT01861457|O2|Outcome|Placebo|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application of placebo treatment with phosphate-buffered saline at 0, 4 and 8 hrs.
698762|NCT01861457|O1|Outcome|Alcohol-Based Nasal Antiseptic|Participants known to exhibit Staph aureus carriage by previous nasal swab screening and randomly assigned received application by nasal swab of alcohol-based nasal antiseptic (Nozin® Nasal Sanitizer®) at 0, 4 and 8 hrs.
698763|NCT01861457|E2|Reported Event|Sham|"Apply 4 rotations of swab to each nostril every four hours ...~Sham"
698764|NCT01861457|E1|Reported Event|Nozin Nasal Sanitizer|"Apply 4 rotations of swab to each nostril every four hours~Nozin Nasal Sanitizer"
698765|NCT01861301|B1|Baseline|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
698766|NCT01861301|P1|Participant Flow|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
698767|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
698768|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
698769|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
698770|NCT01861301|O1|Outcome|Treatment (Tivantinib)|Patients receive tivantinib 360 mg PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
698771|NCT01861301|E1|Reported Event|Treatment (Tivantinib)|Patients receive tivantinib 360 PO BID. Treatment continues in the absence of disease progression or unacceptable toxicity.
698772|NCT01860989|B1|Baseline|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
698773|NCT01860989|P1|Participant Flow|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
699374|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
698774|NCT01860989|O1|Outcome|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
698775|NCT01860989|E1|Reported Event|Total - Cohort 1|Cohort 1 6-12 subjects with Plasmodium falciparum malaria will receive 75 mg KAE609 as a single dose
698776|NCT01860846|B1|Baseline|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698777|NCT01860846|P1|Participant Flow|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698778|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698779|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698780|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698781|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698782|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698783|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698784|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698785|NCT01860846|O1|Outcome|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698786|NCT01860846|E1|Reported Event|Participants With Moderate to Severe Crohn’s Disease|Participants for whom the treating physician had recently initiated an anti-Tumor Necrosis Factor (TNF) treatment
698787|NCT01860703|B1|Baseline|All Subjects|Subjects in this cross-over study all received one dose of each the following: A) a maximum therapeutic dose of 33 mg deferiprone, B) a supratherapeutic dose of 50 mg/kg deferiprone, C) placebo, and D) moxifloxacin (active control). They were randomized to receive these products in different orders: ABCD, BDAC, CADB, or DCBA. Treatments were separated by a 7-day washout period.
698788|NCT01860703|P4|Participant Flow|DCBA|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment D = single oral dose of moxifloxacin Treatment C = single oral dose of placebo Treatment B = single oral dose of 50 mg/kg deferiprone Treatment A = single oral dose of 33 mg/kg deferiprone"
698789|NCT01860703|P3|Participant Flow|CADB|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment C = single oral dose of placebo Treatment A = single oral dose of 33 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment B = single oral dose of 50 mg/kg deferiprone"
698790|NCT01860703|P2|Participant Flow|BDAC|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment B = single oral dose of 50 mg/kg deferiprone Treatment D = single oral dose of moxifloxacin Treatment A = single oral dose of 33 mg/kg deferiprone Treatment C = single oral dose of placebo"
698791|NCT01860703|P1|Participant Flow|ABCD|"All subjects received the same 4 treatments, separated by at least 7 days of washout, but were randomized to receive them in different orders. Subjects in this arm received them in the following order:~Treatment A = single oral dose of 33 mg/kg deferiprone Treatment B = single oral dose of 50 mg/kg deferiprone Treatment C = single oral dose of placebo Treatment D = single oral dose of moxifloxacin"
698792|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698793|NCT01860703|O1|Outcome|Positive Control|A single 400 mg tablet of moxifloxacin. The tablet was administered orally with approximately 240 mL of water.
698794|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
698795|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698796|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698797|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698798|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
698799|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
699375|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
698800|NCT01860703|O2|Outcome|Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698801|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698802|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698803|NCT01860703|O1|Outcome|50 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698804|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698805|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698847|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698806|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698807|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698808|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698809|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698810|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698811|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698812|NCT01860703|O4|Outcome|Arm D - Positive Control|One 400 mg moxifloxacin tablet. Subjects additionally received a single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Tablets were administered orally with approximately 240 mL of water.
698813|NCT01860703|O3|Outcome|Arm C - Placebo Control|A single dose of deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698814|NCT01860703|O2|Outcome|Treatment Arm B - Supratherapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 50 mg/kg (a supra-therapeutic level), rounded to the nearest 250 mg. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698815|NCT01860703|O1|Outcome|Arm A - Maximum Therapeutic Dose|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698816|NCT01860703|O2|Outcome|Placebo Control|A single dose of deferiprone -matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose. Subjects additionally received 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698817|NCT01860703|O1|Outcome|33 mg/kg Deferiprone|A single dose of deferiprone 500 mg tablets at a dosage of 33 mg/kg (the maximum therapeutic level), rounded to the nearest 250 mg. Subjects additionally received deferiprone-matching placebo tablets to provide the same total number of tablets as for a 50 mg/kg dose, plus 1 moxifloxacin-matching placebo tablet. Tablets were administered orally with approximately 240 mL of water.
698818|NCT01860703|E4|Reported Event|Treatment Arm D - Positive Control|"Single dose of deferiprone matching placebo tablets and one 400 mg moxifloxacin tablet.~Deferiprone~moxifloxacin"
698819|NCT01860703|E3|Reported Event|Treatment Arm C - Placebo Control|"Single dose of deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
698942|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
698820|NCT01860703|E2|Reported Event|Treatment Arm B - Supratherapeutic Dose|"Single dose of 50 mg/kg rounded to the nearest 250 mg of deferiprone tablets, and one moxifloxacin matching placebo tablet.~Deferiprone~moxifloxacin matching placebo tablet"
698821|NCT01860703|E1|Reported Event|Treatment Arm A - Maximum Therapeutic Dose|"Single dose of 33 mg/kg rounded to the nearest 250 mg of deferiprone tablets, deferiprone matching placebo tablets and one moxifloxacin matching placebo tablet.~Deferiprone~deferiprone matching placebo tablets~moxifloxacin matching placebo tablet"
698822|NCT01860677|B1|Baseline|All Study Participants|All of the study participants
698823|NCT01860677|P2|Participant Flow|Sham First, Then Active|"Sham first, then Active treatment~Active:~The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator~Sham:~Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
698824|NCT01860677|P1|Participant Flow|Active First, Then Sham|"Active treatment first, then Sham~Active:~The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator~Sham:~Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
698825|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
698826|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
698827|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
698828|NCT01860677|O2|Outcome|Sham Stimulation|"Participants are outfitted with a device that is identical to the Fisher Wallace Cranial Stimulator in appearance but does not deliver any current.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
698829|NCT01860677|O1|Outcome|Active Stimulation|"The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator: The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies."
698830|NCT01860677|E2|Reported Event|Sham Stimulation|Participants are outfitted with a device that is identical in appearance but does not deliver any current.
698831|NCT01860677|E1|Reported Event|Active Stimulation|"The Fisher Wallace Cranial Electrostimulation device generates micro currents of electricity using a patented series of radio frequencies. The device has been designated by the FDA to be minimally invasive and has FDA approval to be used to reduce symptoms associated with anxiety, depression, pain and insomnia. The unit is locked at the factory to deliver a maximal output of 4 mA of current and has a timer that prevents it from staying on longer than 20 minutes. Current will be limited to a maximum of 2 mA.~Fisher Wallace Cranial Stimulator"
698832|NCT01860586|B1|Baseline|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
698833|NCT01860586|P1|Participant Flow|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
698834|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
698943|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
698835|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
698836|NCT01860586|O1|Outcome|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .005 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
698837|NCT01860586|E1|Reported Event|Bevacizumab|"Bevacizumab will be injected into the study eye at end of retinal detachment (rd) surgery and monthly for the following 3 months (total of 4 intravitreal bevacizumab injections)~Bevacizumab: .05 mL of Bevacizumab will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3."
698838|NCT01860573|B3|Baseline|Total|Total of all reporting groups
698839|NCT01860573|B2|Baseline|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698840|NCT01860573|B1|Baseline|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698841|NCT01860573|P2|Participant Flow|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698842|NCT01860573|P1|Participant Flow|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698843|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698844|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698845|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698846|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
699963|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
698848|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698849|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698850|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698851|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698852|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698853|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698854|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698855|NCT01860573|O2|Outcome|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698856|NCT01860573|O1|Outcome|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698857|NCT01860573|E2|Reported Event|High Amino Acids|"Receive 3-4 gm/kg/day amino acids at birth and advanced to goal of 4 gm/kg/day as soon as possible after birth~Amino acids"
698858|NCT01860573|E1|Reported Event|Standard Amino Acids|"Receive 1-2 gm/kg/day amino acids at birth and advanced by 0.5 gm/kg/day for goal of 4 gm/kg/day~Amino acids"
698859|NCT01860534|B3|Baseline|Total|Total of all reporting groups
698860|NCT01860534|B2|Baseline|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698861|NCT01860534|B1|Baseline|Eye Patches Initially Then no Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698862|NCT01860534|P2|Participant Flow|no Eye Patches Initially Then Eye Patches|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group B was unpatched for their first ROP exam and patched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
698944|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
698945|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
698946|NCT01859793|O1|Outcome|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
698863|NCT01860534|P1|Participant Flow|Eye Patch Initially Then no Eye Patch|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care. Two groups were created to ensure comparison of similar gestational ages at the time of initial and secondary exams as younger neonates are often more ill. This added control was to minimize confounding by age or illness.
698864|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698865|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698866|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698923|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698924|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698867|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698868|NCT01860534|O2|Outcome|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698869|NCT01860534|O1|Outcome|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698870|NCT01860534|O2|Outcome|no Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698871|NCT01860534|O1|Outcome|Eye Patches Covers (ROP #1 and ROP #2)|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698947|NCT01859793|E2|Reported Event|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
698948|NCT01859793|E1|Reported Event|Matching Placebo|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
698949|NCT01859715|B4|Baseline|Total|Total of all reporting groups
698950|NCT01859715|B3|Baseline|Nausea-observational Group|Patients given ondansetron for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
698872|NCT01860534|E2|Reported Event|no Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698873|NCT01860534|E1|Reported Event|Eye Patches Covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
698874|NCT01860521|B3|Baseline|Total|Total of all reporting groups
698875|NCT01860521|B2|Baseline|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698876|NCT01860521|B1|Baseline|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698877|NCT01860521|P2|Participant Flow|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
699964|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
698878|NCT01860521|P1|Participant Flow|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698879|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698880|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698881|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698951|NCT01859715|B2|Baseline|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.
698952|NCT01859715|B1|Baseline|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
698882|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698883|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698884|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698885|NCT01860521|O2|Outcome|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698886|NCT01860521|O1|Outcome|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698925|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698926|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698887|NCT01860521|E2|Reported Event|Programmed Intermittent Epidural Bolus|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Programmed Intermittent Epidural Bolus : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698888|NCT01860521|E1|Reported Event|Continuous Epidural Infusion|"Pump : Pump administering either programmed intermittent epidural bolus or continuous epidural infusion for the maintenance of analgesia was used.~Continuous Epidural Infusion : An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered."
698889|NCT01860170|B4|Baseline|Total|Total of all reporting groups
698890|NCT01860170|B3|Baseline|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698953|NCT01859715|P3|Participant Flow|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
698954|NCT01859715|P2|Participant Flow|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
698955|NCT01859715|P1|Participant Flow|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
698891|NCT01860170|B2|Baseline|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698892|NCT01860170|B1|Baseline|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698893|NCT01860170|P3|Participant Flow|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698894|NCT01860170|P2|Participant Flow|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698895|NCT01860170|P1|Participant Flow|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698927|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698928|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698929|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698896|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698897|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698956|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
698957|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
698958|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
698959|NCT01859715|O3|Outcome|Nausea-observational Group|Patients given ondansetron 4mg for reported nausea or vomiting by ED provider decision or by triage nurse. This is an observational cohort only.
698898|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698899|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698900|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698901|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698902|NCT01860170|O3|Outcome|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698903|NCT01860170|O2|Outcome|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698930|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698931|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
699965|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
698904|NCT01860170|O1|Outcome|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698905|NCT01860170|E3|Reported Event|Cohort 3-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 3-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698906|NCT01860170|E2|Reported Event|Cohort 2-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 2-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698907|NCT01860170|E1|Reported Event|Cohort 1-Bortezomib (Velcade®)|"Bortezomib (Velcade®) 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3.~Cohort 1-Bortezomib (Velcade ®): Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
698908|NCT01860079|B3|Baseline|Total|Total of all reporting groups
698909|NCT01860079|B2|Baseline|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
698910|NCT01860079|B1|Baseline|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
698911|NCT01860079|P2|Participant Flow|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure.
698912|NCT01860079|P1|Participant Flow|Early Discharge Group|In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
698913|NCT01860079|O2|Outcome|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure
698914|NCT01860079|O1|Outcome|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours."
698915|NCT01860079|E2|Reported Event|Standard Discharge Group|Patients who stay longer (96-120 hours) as of a standard procedure. During the two year study period, 900 PPCI patients arrived at the three different study centers. After the exclusion of 131 patients due to primary exclusion criteria 769 patients were randomized in to two groups. There were 385 patients in the standard discharge group. Sixteen patients were excluded due to primary exclusion criteria such as signs of heart failure (n=7, %), clinically significant arrhythmia requiring treatment (n=3, %), chest pain recurrence (n=4,%), cardiogenic shock (n=1,%). Furthermore, a total of 6 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 363 patients in the standard discharge group.
698916|NCT01860079|E1|Reported Event|Early Discharge Group|"In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~early discharge: In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.~During 2 year study period, 900 PPCI patients arrived at the three different study centers. 769 patients were randomized in to two groups. There were 384 patients in the early discharge arm. Four patients were excluded due to social repatriation reasons. Furthermore, a total of 10 patients were excluded for follow up reasons such as loosing contact with the patient or refusing to show up in the end of 1 month at the cardiology outpatient clinic. The study was terminated with 370 patients in the early discharge group."
698917|NCT01859949|B3|Baseline|Total|Total of all reporting groups
698918|NCT01859949|B2|Baseline|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698919|NCT01859949|B1|Baseline|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698920|NCT01859949|P2|Participant Flow|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698921|NCT01859949|P1|Participant Flow|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698922|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698932|NCT01859949|O2|Outcome|Dose-Remaining Group|Participants who were treated with somatropin 0.067 mg/kg/day in previous study for 12 months were maintained on the same dose
698933|NCT01859949|O1|Outcome|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698934|NCT01859949|E2|Reported Event|Dose-Remainig Group|Participants in the 0.067 mg/kg/day group in previous study were maintained on the dose in this expention study
698935|NCT01859949|E1|Reported Event|Dose-Increasing Group|Participants who were treated with somatropin 0.033 mg/kg/day in previous study for 12 months received a dose of 0.067 mg/kg/day
698936|NCT01859793|B3|Baseline|Total|Total of all reporting groups
698937|NCT01859793|B2|Baseline|Sitagliptin 1st|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
698938|NCT01859793|B1|Baseline|Matching Placebo 1st|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally"
698939|NCT01859793|P2|Participant Flow|Sitagliptin First Then Placebo|sitagliptin: 100 mg pill, administered once/day orally for 8 weeks followed by matching placebo for 8 weeks following a 4 week washout period.
698940|NCT01859793|P1|Participant Flow|Placebo 1st Then Sitagliptin|"Matching Placebo for Sitagliptin~Placebo: Matching placebo in appearance given once/day orally for 8 weeks followed by 8 weeks of 100 mg sitaglipin/day separated by a 4 week washout period"
698941|NCT01859793|O2|Outcome|Sitagliptin|"100mg pill, PO administered once daily.~sitagliptin: 100 mg pill, administered once/day orally"
698960|NCT01859715|O2|Outcome|Hydrocodone/Acetaminophen Group|Subjects given or hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
698961|NCT01859715|O1|Outcome|Oxycodone Group|Subjects given oxycodone 5mg mg by ED provider decision or by triage nurse randomization.
698962|NCT01859715|E3|Reported Event|Nausea-observational Group|"Patients given ondansetron by ED provider decision or by triage nurse. This is an observational cohort only.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Ondansetron: Subjects given ondansetron for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only."
698963|NCT01859715|E2|Reported Event|Hydrocodone/Acetaminophen Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
698964|NCT01859715|E1|Reported Event|Oxycodone Group|"Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Oxycodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization.~Hydrocodone: Subjects given either oxycodone 5mg or hydrocodone/acetaminophen 5mg/500 mg by ED provider decision or by triage nurse randomization."
698965|NCT01859702|B1|Baseline|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
698966|NCT01859702|P1|Participant Flow|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
698967|NCT01859702|O1|Outcome|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
698968|NCT01859702|E1|Reported Event|VIGADEXA|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution, 1 drop instilled in the study eye 2 days before surgery, followed by 1 drop instilled 4 times a day the day before surgery. On the day of surgery, 1 drop was instilled 60 minutes prior to the procedure.
698969|NCT01859637|B1|Baseline|Zarzio®/Filgrastim HEXAL®|Open label single arm. All patients received Zarzio®/Filgrastim HEXAL® subcutaneously dosed as per recommendations in SmPC.
698970|NCT01859637|P1|Participant Flow|Zarzio®/Filgrastim HEXAL® (EP2006)|Open label single arm. All patients received Zarzio® subcutaneously dosed as per recommendations in Summary of Product Characteristics (SmPC).
698971|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
698972|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
698973|NCT01859637|O1|Outcome|Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
698974|NCT01859637|E1|Reported Event|Open-label Zarzio®/Filgrastim HEXAL®|All patients received open-label Zarzio®/Filgrastim HEXAL®
698975|NCT01859611|B1|Baseline|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
698976|NCT01859611|P1|Participant Flow|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
698977|NCT01859611|O1|Outcome|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
698978|NCT01859611|E1|Reported Event|Radiofrequency|"Radiofrequency (RF) treatment with the TriActive+ RF device on the peri-oral and/or peri-orbital areas of the face once a week for eight weeks.~TriActive+ RF: Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
698979|NCT01859598|B1|Baseline|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
698980|NCT01859598|P1|Participant Flow|6-month Follow-up for Basal Insulin Treatment Study (ORBIT)|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);"
698981|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
698982|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341, among them, 10416 patients had FPG information"
698983|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
698984|NCT01859598|O1|Outcome|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
698985|NCT01859598|O1|Outcome|Basal Insulin Treatment Study (ORBIT)|
698986|NCT01859598|E1|Reported Event|Follow up for 6 Months|"At the baseline stage:~Patients registered to assess the eligibility(N=19894); Violate inclusion criteria (N=346); Excluded (N=553);~At visit 1: Patients remained at baseline, N=18995; Loss to follow-up, N=1742 At visit 2, N=17253; Come back at visit 3, N=605 Loss to follow-up, N=1517 At visit 3, N=16341"
698987|NCT01859507|B1|Baseline|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
698988|NCT01859507|P1|Participant Flow|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
699056|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
699057|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
699058|NCT01859247|E8|Reported Event|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
699059|NCT01859247|E7|Reported Event|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
699105|NCT01858766|B12|Baseline|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
698989|NCT01859507|O1|Outcome|BOTOX Group|"Injection of BOTOX 100 units vial as a single dose intramuscular in the perineal muscles. Proper informed consent forms will be signed. In most of the cases we use local anesthetic before injection. However in V4 and 5 we resort to general anesthesia. We followed up the patient by phone calls daily for possible adverse effects following the procedure for 4 days, which is the interval allowed for the BOTOX to be fully effective. The patient is then instructed to attend dilatation sessions twice weekly in the clinic, in the presence of the husband, for 3-4 weeks. We use silicone dilators covered by lubricated condoms. We start each session with the appropriate size of the dilator according to the capacity of the introitus and increase the size gradually thereafter. We proceed till the patient uses the largest dilator with no or limited pain. The patient is then advised then to try to have intercourse and report back to us.~Botox: In the first session, proper histor"
698990|NCT01859507|O1|Outcome|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
698991|NCT01859507|E1|Reported Event|Botox|"Injection of Clostridium Botulinum type A neurotoxin complex in the perineal muscles in resistant cases of vaginismus.~Trade Name:~BOTOX 100 units vial~Injection of Botox in the perineal muscles in resistant cases of vaginismus"
698992|NCT01859494|B1|Baseline|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
698993|NCT01859494|P1|Participant Flow|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
698994|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
698995|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
698996|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
698997|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
699034|NCT01859247|B1|Baseline|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
699376|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
698998|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
698999|NCT01859494|O1|Outcome|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
699000|NCT01859494|E1|Reported Event|Users of the Monitoring System|"Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.~NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma."
699001|NCT01859390|B3|Baseline|Total|Total of all reporting groups
699002|NCT01859390|B2|Baseline|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699060|NCT01859247|E6|Reported Event|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
699061|NCT01859247|E5|Reported Event|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
699062|NCT01859247|E4|Reported Event|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
699966|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699003|NCT01859390|B1|Baseline|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699004|NCT01859390|P2|Participant Flow|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699005|NCT01859390|P1|Participant Flow|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699006|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699007|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699008|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699035|NCT01859247|P8|Participant Flow|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
699009|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699010|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699011|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699012|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699063|NCT01859247|E3|Reported Event|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
699967|NCT01854645|O5|Outcome|Placebo|Placebo MDI
699013|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699014|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699015|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699016|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699017|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699018|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699019|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699020|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699021|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699022|NCT01859390|O2|Outcome|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699064|NCT01859247|E2|Reported Event|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
701080|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
699023|NCT01859390|O1|Outcome|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699024|NCT01859390|E2|Reported Event|Control Multivitamin|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period for all participants and for 16 weeks for those randomized to this comparative therapy.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699025|NCT01859390|E1|Reported Event|AquADEKs-2|"Two control multivitamin softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 4 weeks for the screening run in period. For those subjects randomized to the AquADEKs-2 arm, two AquADEKs-2 softgel capsules will be taken orally on a once daily basis with pancreatic enzymes and a glass of milk or fat-containing meal for 16 weeks.~AquADEKs-2: AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.~control multivitamin: The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants."
699026|NCT01859247|B9|Baseline|Total|Total of all reporting groups
699027|NCT01859247|B8|Baseline|Subject 8|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Supplemental Motor Area Primary Motor Cortex Sham Dorsal Premotor Cortex"
699028|NCT01859247|B7|Baseline|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
699029|NCT01859247|B6|Baseline|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
699030|NCT01859247|B5|Baseline|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
699031|NCT01859247|B4|Baseline|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
699032|NCT01859247|B3|Baseline|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
699033|NCT01859247|B2|Baseline|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
699089|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
699036|NCT01859247|P7|Participant Flow|Subject 7|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Primary Motor Cortex Dorsal Premotor Cortex Anterior Cingulate Cortex Supplemental Motor Area"
699037|NCT01859247|P6|Participant Flow|Subject 6|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex"
699038|NCT01859247|P5|Participant Flow|Subject 5|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Sham Dorsal Premotor Cortex Primary Motor Cortex Supplemental Motor Area Anterior Cingulate Cortex"
699039|NCT01859247|P4|Participant Flow|Subject 4|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Supplemental Motor Area Sham Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex"
699040|NCT01859247|P3|Participant Flow|Subject 3|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Dorsal Premotor Cortex Supplemental Motor Area Sham Primary Motor Cortex Anterior Cingulate Cortex"
699041|NCT01859247|P2|Participant Flow|Subject 2|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Anterior Cingulate Cortex Primary Motor Cortex Dorsal Premotor Cortex Sham Supplemental Motor Area"
699042|NCT01859247|P1|Participant Flow|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
699043|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
699044|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
699045|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
699046|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes:
699047|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
699048|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes
699049|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes
699050|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes
699051|NCT01859247|O2|Outcome|Anterior Cingulate rTMS|0.2Hz for 15 minutes
699052|NCT01859247|O1|Outcome|Primary Motor Cortex rTMS|0.2Hz for 15 minutes
699053|NCT01859247|O5|Outcome|Sham rTMS|0.2Hz for 15 minutes:
699054|NCT01859247|O4|Outcome|Supplemental Motor Area rTMS|0.2Hz for 15 minutes:
699055|NCT01859247|O3|Outcome|Dorsal Premotor rTMS|0.2Hz for 15 minutes:
699065|NCT01859247|E1|Reported Event|Subject 1|"Received rTMS intervention in the following order, each at 0.2Hz for 15 minutes:~Primary Motor Cortex Supplemental Motor Area Sham Dorsal Premotor Cortex Anterior Cingulate Cortex"
699066|NCT01859143|B3|Baseline|Total|Total of all reporting groups
699067|NCT01859143|B2|Baseline|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699068|NCT01859143|B1|Baseline|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
699069|NCT01859143|P2|Participant Flow|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699070|NCT01859143|P1|Participant Flow|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
699071|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699072|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
699073|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699074|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
699075|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699076|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
699077|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699078|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) FFU of trivalent influenza vaccine administered as intranasal spray on Day 1.
699079|NCT01859143|O2|Outcome|Placebo|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699080|NCT01859143|O1|Outcome|Trivalent Influenza Vaccine|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
699081|NCT01859143|E2|Reported Event|PLACEBO|A single dose of placebo matched to trivalent influenza vaccine administered as intranasal spray on Day 1.
699082|NCT01859143|E1|Reported Event|TRIVALENT VACCINE|A single dose of 10^(7.0 +/- 0.5) fluorescent focus units (FFU) of trivalent influenza vaccine administered as intranasal spray on Day 1.
699083|NCT01859078|B1|Baseline|Baricitinib + Digoxin|"Digoxin - 0.5 mg administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 16.~Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
699084|NCT01859078|P1|Participant Flow|Baricitinib + Digoxin|"Digoxin - 0.5 milligrams (mg) administered orally, twice daily (BID), 12 hours apart on Day 1. Then, 0.25 mg administered orally, once daily (QD) on Days 2 through 16.~Baricitinib - 10 mg administered orally, QD, immediately prior to digoxin on Days 8 through 16."
699085|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
699086|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
699087|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
699088|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
699090|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
699091|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
699092|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
699093|NCT01859078|O2|Outcome|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
699094|NCT01859078|O1|Outcome|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
699095|NCT01859078|E2|Reported Event|Baricitinib + Digoxin|10 mg baricitinib administered orally, QD, immediately prior to 0.25 mg digoxin administered orally, QD on Days 8 through 16.
699096|NCT01859078|E1|Reported Event|Digoxin Only|0.5 mg digoxin administered orally, BID, 12 hours apart on Day 1. Then, 0.25 mg administered orally, QD on Days 2 through 7.
699097|NCT01858766|B20|Baseline|Total|Total of all reporting groups
699098|NCT01858766|B19|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699099|NCT01858766|B18|Baseline|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
699100|NCT01858766|B17|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699101|NCT01858766|B16|Baseline|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
699102|NCT01858766|B15|Baseline|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699103|NCT01858766|B14|Baseline|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
699104|NCT01858766|B13|Baseline|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699106|NCT01858766|B11|Baseline|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
699107|NCT01858766|B10|Baseline|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
699108|NCT01858766|B9|Baseline|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
699109|NCT01858766|B8|Baseline|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
699110|NCT01858766|B7|Baseline|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
699111|NCT01858766|B6|Baseline|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
699112|NCT01858766|B5|Baseline|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
699113|NCT01858766|B4|Baseline|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
699114|NCT01858766|B3|Baseline|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
699115|NCT01858766|B2|Baseline|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
699116|NCT01858766|B1|Baseline|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
699117|NCT01858766|P19|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699118|NCT01858766|P18|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
699119|NCT01858766|P17|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699120|NCT01858766|P16|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
699121|NCT01858766|P15|Participant Flow|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699122|NCT01858766|P14|Participant Flow|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
699123|NCT01858766|P13|Participant Flow|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699124|NCT01858766|P12|Participant Flow|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
699125|NCT01858766|P11|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
699126|NCT01858766|P10|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
699127|NCT01858766|P9|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
699128|NCT01858766|P8|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
699129|NCT01858766|P7|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
699130|NCT01858766|P6|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
699131|NCT01858766|P5|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
699132|NCT01858766|P4|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
699133|NCT01858766|P3|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
699134|NCT01858766|P2|Participant Flow|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
699135|NCT01858766|P1|Participant Flow|SOF+VEL 25 mg 12 Weeks (GT1)|Sofosbuvir (SOF) 400 mg tablet + velpatasvir (VEL) 25 mg tablet administered orally once daily for 12 weeks (genotype (GT) 1)
699136|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699137|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
699138|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699139|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
699140|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699141|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
699142|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699143|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
699144|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
699145|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
699968|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699146|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
699147|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
699148|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
699149|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
699150|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
699151|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
699152|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
699153|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
699154|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
699155|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699156|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
699157|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699158|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
699159|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699160|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
699161|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699162|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
699163|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
699164|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
699165|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
699166|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
699167|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
699168|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
699169|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
699170|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
699171|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
699172|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
699173|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
699174|NCT01858766|O6|Outcome|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
699175|NCT01858766|O5|Outcome|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
699176|NCT01858766|O4|Outcome|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
699177|NCT01858766|O3|Outcome|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
699178|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
699179|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
699180|NCT01858766|O19|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699181|NCT01858766|O18|Outcome|SOF+VEL 100 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 2)
699182|NCT01858766|O17|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 2)
699183|NCT01858766|O16|Outcome|SOF+VEL 25 mg 8 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 2)
699184|NCT01858766|O15|Outcome|SOF+VEL 100 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699185|NCT01858766|O14|Outcome|SOF+VEL 100 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (genotype 1)
699186|NCT01858766|O13|Outcome|SOF+VEL 25 mg + RBV 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (genotype 1)
699969|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699187|NCT01858766|O12|Outcome|SOF+VEL 25 mg 8 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (genotype 1)
699188|NCT01858766|O11|Outcome|SOF+VEL 100 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 6)
699189|NCT01858766|O10|Outcome|SOF+VEL 25 mg 12 Weeks (GT6)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 6)
699190|NCT01858766|O9|Outcome|SOF+VEL 25 mg 12 Weeks (GT5)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 5)
699191|NCT01858766|O8|Outcome|SOF+VEL 100 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 4)
699192|NCT01858766|O7|Outcome|SOF+VEL 25 mg 12 Weeks (GT4)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 4)
699193|NCT01858766|O6|Outcome|SOF+VEL 100 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 3)
699194|NCT01858766|O5|Outcome|SOF+VEL 25 mg 12 Weeks (GT3)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 3)
699195|NCT01858766|O4|Outcome|SOF+VEL 100 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 2)
699196|NCT01858766|O3|Outcome|SOF+VEL 25 mg 12 Weeks (GT2)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 2)
699197|NCT01858766|O2|Outcome|SOF+VEL 100 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (genotype 1)
699198|NCT01858766|O1|Outcome|SOF+VEL 25 mg 12 Weeks (GT1)|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (genotype 1)
699199|NCT01858766|E6|Reported Event|SOF+VEL 100 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
699200|NCT01858766|E5|Reported Event|SOF+VEL 100 mg 8 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 8 weeks (all genotypes)
699201|NCT01858766|E4|Reported Event|SOF+VEL 25 mg + RBV 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks (all genotypes)
699202|NCT01858766|E3|Reported Event|SOF+VEL 25 mg 8 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 8 weeks (all genotypes)
699203|NCT01858766|E2|Reported Event|SOF+VEL 100 mg 12 Weeks|SOF 400 mg tablet + VEL 100 mg tablet administered orally once daily for 12 weeks (all genotypes)
699204|NCT01858766|E1|Reported Event|SOF+VEL 25 mg 12 Weeks|SOF 400 mg tablet + VEL 25 mg tablet administered orally once daily for 12 weeks (all genotypes)
699205|NCT01858701|B1|Baseline|Overall|Lotrafilcon B toric contact lenses and comfilcon A toric contact lenses worn during Period 1 and Period 2 in a crossover assignment.
699206|NCT01858701|P2|Participant Flow|Biofinity Toric / AO for Astig|Comfilcon A toric contact lenses worn in Period 1, followed by lotrafilcon B toric contact lenses in Period 2.
699207|NCT01858701|P1|Participant Flow|AO for Astig / Biofinity Toric|Lotrafilcon B toric contact lenses worn in Period 1, followed by comfilcon A toric contact lenses in Period 2.
699208|NCT01858701|O2|Outcome|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
699209|NCT01858701|O1|Outcome|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
699210|NCT01858701|E2|Reported Event|Biofinity Toric|Comfilcon A toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
699211|NCT01858701|E1|Reported Event|Air Optix for Astig|Lotrafilcon B toric contact lenses worn bilaterally on a daily wear basis (removed nightly) during Period 1 or Period 2, for 30 days.
699212|NCT01858636|B1|Baseline|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6F and 8F devices: These devices are used for the vascular closure procedure
699213|NCT01858636|P1|Participant Flow|Angio-Seal VIP Vascular Closure|Angio-Seal VIP 6 French (6F) and 8 French (8F) devices: These devices are used for the vascular closure procedure
699214|NCT01858636|O1|Outcome|Deployed Subjects|Subjects with Angio-Seal deployed
699215|NCT01858636|O1|Outcome|Deployed Subjects|Percentage of subjects who experienced a major vascular complication during 30-days post procedure.
699216|NCT01858636|E1|Reported Event|Deployed Subjects|Adverse Events (AEs) are provided for all subjects that underwent a study device deployment.
699217|NCT01858376|B1|Baseline|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
699218|NCT01858376|P1|Participant Flow|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
699219|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
699238|NCT01857713|E1|Reported Event|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and were their own controls. Baseline measures were compared to each of the prescribed follow-up visit measures.
699220|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
699221|NCT01858376|O1|Outcome|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
699222|NCT01858376|E1|Reported Event|Capros Dietary Supplement|"Subjects will take Capros supplement (1 capsule) twice a day for 12 weeks.The subjects then will have blood drawn seven times throughout the course of the study.~Capros dietary supplement: Study participants will have 2 to 3 baseline blood draws (as needed), 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured."
699223|NCT01857882|B3|Baseline|Total|Total of all reporting groups
699224|NCT01857882|B2|Baseline|Standard Care|Routine pre-consultation education
699225|NCT01857882|B1|Baseline|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
699226|NCT01857882|P2|Participant Flow|Standard Care|Routine pre-consultation education
699227|NCT01857882|P1|Participant Flow|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
699228|NCT01857882|O2|Outcome|Standard Care|Routine pre-consultation education
699250|NCT01857622|E2|Reported Event|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
699377|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699229|NCT01857882|O1|Outcome|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
699230|NCT01857882|E2|Reported Event|Standard Care|Routine pre-consultation education
699231|NCT01857882|E1|Reported Event|Decision Support Workshop|"The decision support workshop will be 2 hours in duration on the morning of the consultation and will be facilitated by a dedicated social worker from psycho-oncology.~Decision Support Workshop: Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system~Social worker (30 mins): values clarification exercise~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
699232|NCT01857713|B1|Baseline|Fitted With Reza Band UES Assist Device|Patients were their own control and Fitted with Reza Band UES Assist Device. Results were obtained by measuring symptoms at baseline and then compared at each of the prescribed follow-up visits.
699233|NCT01857713|P1|Participant Flow|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and served as their own control. Baseline measures were comported to follow-up visit measures.
699234|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients were fitted with the Reza Band UES Assist Device and Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
699235|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
699236|NCT01857713|O1|Outcome|Fitted With Reza Band UES Assist Device|Patients that have been clinically diagnosed with esophagopharyngeal reflux with extra-esophageal symptoms (i.e., chronic cough, choking, aspiration, chronic post nasal drip, globus, sore throat, throat clearing).
699237|NCT01857713|O1|Outcome|Reza Band|Participants fitted with Reza Band UES Assist Device
699239|NCT01857622|B4|Baseline|Total|Total of all reporting groups
699240|NCT01857622|B3|Baseline|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
699241|NCT01857622|B2|Baseline|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
699242|NCT01857622|B1|Baseline|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
699243|NCT01857622|P3|Participant Flow|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
699244|NCT01857622|P2|Participant Flow|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
699245|NCT01857622|P1|Participant Flow|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
699246|NCT01857622|O3|Outcome|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
699247|NCT01857622|O2|Outcome|Normal/MiRI Low-dose Group|"Normal or Mild Renal impairment DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors (body weight of ≤ 60 kg or the presence of concurrent treatment with quinidine or verapamil). DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 30mg: oral DU-176b 30mg once daily"
699248|NCT01857622|O1|Outcome|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
699249|NCT01857622|E3|Reported Event|Normal/MiRI High-dose Group|"Normal or Mild Renal Impairment DU-176b was orally administered at a dose of 60 mg once daily for 12 weeks in subjects who had none of the dose adjustment factors. DU-176b was orally administered at a dose of 30 mg once daily for 12 weeks to subjects who had any of the dose adjustment factors, irrespective of the number of dose adjustment factors.~DU-176b 60mg: oral DU-176b 60mg once daily"
699251|NCT01857622|E1|Reported Event|SRI 15mg|"Severe Renal Impairment DU-176b was orally administered at a dose of 15 mg once daily for 12 weeks.~DU-176b 15mg: oral DU-176b 15mg once daily"
699252|NCT01857583|B5|Baseline|Total|Total of all reporting groups
699253|NCT01857583|B4|Baseline|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
699254|NCT01857583|B3|Baseline|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
699255|NCT01857583|B2|Baseline|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
699256|NCT01857583|B1|Baseline|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
699257|NCT01857583|P4|Participant Flow|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min) Fondaparinux"
699258|NCT01857583|P3|Participant Flow|SRI 15mg DU176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
699259|NCT01857583|P2|Participant Flow|SRI 15mg DU176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
699260|NCT01857583|P1|Participant Flow|MiRI 30mg DU176b (50 mL/Min ≤ CLCR ≤ 80mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
699261|NCT01857583|O4|Outcome|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~(20 mL/min ≤ CLCR < 30mL/min)"
699262|NCT01857583|O3|Outcome|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
699263|NCT01857583|O2|Outcome|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
699264|NCT01857583|O1|Outcome|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
699265|NCT01857583|E4|Reported Event|Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)|"Fondaparinux subcutaneously administered at a dose of 1.5mg once daily for 14 days.~Fondaparinux (20 mL/min ≤ CLCR < 30mL/min)"
699266|NCT01857583|E3|Reported Event|SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU176b once daily for 14 days.~(20 mL/min ≤ CLCR < 30 mL/min) 15mg DU-176b"
699267|NCT01857583|E2|Reported Event|SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)|"Severe Renal Impairment group orally administered 15mg DU-176b once daily for 14 days.~(15 mL/min ≤ CLCR < 20 mL/min) 15mg DU-176b"
699268|NCT01857583|E1|Reported Event|MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)|"Mild Renal Impairment group orally administered 30mg DU176b once daily for 14 days.~(50 mL/min ≤ CLCR ≤ 80 mL/min) 30mg DU-176b"
699269|NCT01857531|B1|Baseline|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily for the first 3 days, 800mg daily for the next 3 days and 1200mg daily for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699270|NCT01857531|P1|Participant Flow|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699271|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699272|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699273|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699274|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699275|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699931|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699276|NCT01857531|O1|Outcome|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699277|NCT01857531|E1|Reported Event|Ganaxolone -- Nicotine Patch|"Pre-Quit Period:~Ganaxolone -- 400mg daily (200mg bid) for the first 3 days, 800mg daily (400mg bid) for the next 3 days and 1200mg daily (600mg bid) for the remainder of the first 2 wks.~Nicotine Patches -- 21mg/24h nicotine patches applied daily during wks. 3 and 4.~Post-Quit Period:~Ganaxolone -- 1200mg daily for wk. 5, 800mg daily for 3 days, and 400mg daily for 3 days.~Nicotine Patches -- 21mg/24h for 4 wks., 14mg/24h for 1 wk., and 7mg/24h for 1 wk."
699278|NCT01857362|B1|Baseline|Overall Study|All treatment arms
699279|NCT01857362|P2|Participant Flow|Nitisinone 2 x 10 mg, Then Nitisinone 1 x 20 mg|Participants first received two nitisinone capsules of 10 mg. After washout of 3 weeks participants then received one nitisinone capsule of 20 mg.
699280|NCT01857362|P1|Participant Flow|Nitisinone 1 x 20 mg, Then Nitisinone 2 x 10 mg|Participants first received one nitisinone capsule of 20 mg. After washout of 3 weeks participants then received two nitisinone capsules of 10 mg.
699281|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
699282|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
699283|NCT01857362|O2|Outcome|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
699284|NCT01857362|O1|Outcome|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
699285|NCT01857362|E2|Reported Event|Nitisinone 1 x 20 mg Capsules|Nitisinone 1 x 20 mg capsules
699286|NCT01857362|E1|Reported Event|Nitisinone 2 x 10 mg Capsules|Nitisinone 2 x 10 mg capsules
699287|NCT01857323|B1|Baseline|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699288|NCT01857323|P1|Participant Flow|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699289|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699290|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699291|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699292|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699293|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699294|NCT01857323|O1|Outcome|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699295|NCT01857323|E1|Reported Event|Albuterol Spiromax®|The approximate 50-day treatment period consisted of 180 mcg (90 mcg/dose cycle, 2 dose cycles) twice daily study medication administration with Albuterol Spiromax with dose-counter.
699296|NCT01857297|B3|Baseline|Total|Total of all reporting groups
699297|NCT01857297|B2|Baseline|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699298|NCT01857297|B1|Baseline|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699299|NCT01857297|P2|Participant Flow|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699300|NCT01857297|P1|Participant Flow|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699301|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699302|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699303|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699304|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699305|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699306|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699307|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699308|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699309|NCT01857297|O2|Outcome|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699372|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699310|NCT01857297|O1|Outcome|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699311|NCT01857297|E2|Reported Event|Older Adults (60 Years or Older)|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699312|NCT01857297|E1|Reported Event|Adults (18 to 59 Years)|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
699313|NCT01857258|B1|Baseline|Baseline Participant Characteristics|All participants completed both arms of the cross-over study
699314|NCT01857258|P2|Participant Flow|Control First, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
699315|NCT01857258|P1|Participant Flow|Green Tea First, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~The green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose. The confection provides 50 grams of starch and 1 gram of green tea concentrate."
699316|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699317|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699318|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699319|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699349|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699320|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699321|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699322|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699323|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699324|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699325|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699326|NCT01857258|O2|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699327|NCT01857258|O1|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699328|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699329|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699330|NCT01857258|O2|Outcome|Control|"Participants will be provided a confection devoid of green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699331|NCT01857258|O1|Outcome|Green Tea|"Participants will be provided a confection containing green tea concentrate~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699332|NCT01857258|E2|Reported Event|Control, Then Green Tea|"Participants will be provided a confection devoid of green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection containing green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699333|NCT01857258|E1|Reported Event|Green Tea, Then Control|"Participants will be provided a confection containing green tea concentrate in fasting state one time. After a washout period of 7 days, they then will be provided a confection devoid of green tea concentrate in fasting state one time.~Green Tea Concentrate: Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose"
699334|NCT01857206|B3|Baseline|TOTAL|Total of all reporting groups
699373|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699335|NCT01857206|B2|Baseline|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699336|NCT01857206|B1|Baseline|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699337|NCT01857206|P2|Participant Flow|TIVf|Subjects ≥4 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699338|NCT01857206|P1|Participant Flow|TIVc|Subjects ≥4 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699339|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699340|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699341|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699342|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699343|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699344|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699345|NCT01857206|O2|Outcome|TIVf (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699346|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699347|NCT01857206|O4|Outcome|TIVf (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699348|NCT01857206|O3|Outcome|TIVc (≥9 to ≤17 Years)|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699970|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699350|NCT01857206|O1|Outcome|TIVc (≥4 to ≤8 Years)|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699351|NCT01857206|E4|Reported Event|TIVf(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699352|NCT01857206|E3|Reported Event|TIVc(9-17Years )|Subjects ≥9 to ≤17 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699353|NCT01857206|E2|Reported Event|TIVf(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of egg-derived trivalent influenza vaccine based on their previous vaccination status.
699354|NCT01857206|E1|Reported Event|TIVc(4-8Years )|Subjects ≥4 to ≤8 years of age received one or two doses of mammalian cell-culture-derived trivalent influenza vaccine based on their previous vaccination status.
699355|NCT01857102|B1|Baseline|Dispensed Subjects|All subjects that were dispensed at least one study lens.
699356|NCT01857102|P2|Participant Flow|Etafilcon A for Astigmatism/Etafilcon A|Subjects that first received the etafilcon A for Astigmatism lens and then received the etafilcon A lens.
699357|NCT01857102|P1|Participant Flow|Etafilcon A/ Etafilcon A for Astigmatism|Subjects that first received the etafilcon A lens and then received the etafilcon A for Astigmatism lens.
699358|NCT01857102|O2|Outcome|Etafilcon A for Astigmatism|Subjects that received etafilcon A for Astigmatism lens in either the first or second period of the study.
699359|NCT01857102|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens during the first or second period of the study.
699360|NCT01857102|O2|Outcome|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
699361|NCT01857102|O1|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
699362|NCT01857102|E2|Reported Event|Etafilcon A for Astigmatism|Subjects that received the etafilcon A for Astigmatism lens in either the first or second period of the study.
699363|NCT01857102|E1|Reported Event|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
699364|NCT01857063|B3|Baseline|Total|Total of all reporting groups
699365|NCT01857063|B2|Baseline|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
699366|NCT01857063|B1|Baseline|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
699367|NCT01857063|P2|Participant Flow|Placebo/Montelukast|Participants receive placebo chewable tablets for 7 days during Period 1 and receive montelukast 5 mg chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
699368|NCT01857063|P1|Participant Flow|Montelukast/Placebo|Participants receive montelukast 5 mg chewable tablets for 7 days during Period 1 and receive placebo chewable tablets for 7 days during Period 2. There is a 7-day washout period between Periods 1 and 2.
699369|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699370|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699371|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699378|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699379|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699380|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699381|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699382|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699383|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699384|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699385|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699386|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699387|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699388|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699389|NCT01857063|O2|Outcome|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699390|NCT01857063|O1|Outcome|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699391|NCT01857063|E2|Reported Event|Placebo|Participants receive placebo for 7 days, regardless of sequence.
699392|NCT01857063|E1|Reported Event|Montelukast|Participants receive montelukast 5 mg for 7 days, regardless of sequence.
699393|NCT01856933|B1|Baseline|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
699394|NCT01856933|P1|Participant Flow|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
699395|NCT01856933|O1|Outcome|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
701081|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
699396|NCT01856933|E1|Reported Event|PSMA ADC|"2.5 mg/kg, IV, over 60 minutes every 3 weeks~PSMA ADC: 2.5 mg/kg, IV, over 60 minutes every 3 weeks"
699397|NCT01856764|B3|Baseline|Total|Total of all reporting groups
699398|NCT01856764|B2|Baseline|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
699399|NCT01856764|B1|Baseline|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
699400|NCT01856764|P2|Participant Flow|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
699401|NCT01856764|P1|Participant Flow|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
699402|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
699403|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
699404|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
699405|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
699406|NCT01856764|O2|Outcome|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
699407|NCT01856764|O1|Outcome|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
699408|NCT01856764|E2|Reported Event|Vehicle Cream|Roflumilast formulation vehicle, cream, topically, twice daily for up to 15 days.
699409|NCT01856764|E1|Reported Event|0.5% Roflumilast Cream|Roflumilast 0.5%, cream, topically, twice daily for up to 15 days.
699410|NCT01856686|B3|Baseline|Total|Total of all reporting groups
699411|NCT01856686|B2|Baseline|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699412|NCT01856686|B1|Baseline|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699413|NCT01856686|P2|Participant Flow|Low Carbohydrate Diet|This group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
699414|NCT01856686|P1|Participant Flow|BP22042013|This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
699415|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699416|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699417|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699418|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699419|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699420|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699421|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699422|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699423|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699424|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699425|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699426|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699799|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699427|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699428|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699429|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699430|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699431|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699432|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699433|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699434|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699435|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699436|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699437|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699438|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699439|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699440|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699441|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699442|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699443|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699444|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699445|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699446|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699447|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699637|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699448|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699449|NCT01856686|O2|Outcome|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699450|NCT01856686|O1|Outcome|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699451|NCT01856686|E2|Reported Event|Low Carbohydrate Diet|"the second group of patients receive diet of 2.000 Kilo calories without rapidly absorbed carbohydrates and without proteins supplements~Low carbohydrate diet: the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements"
699452|NCT01856686|E1|Reported Event|BP22042013|"This group of patients receive 2.000 kilocalories diet(60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.~BP22042013: This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes."
699453|NCT01856673|B4|Baseline|Total|Total of all reporting groups
699454|NCT01856673|B3|Baseline|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
699455|NCT01856673|B2|Baseline|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
699456|NCT01856673|B1|Baseline|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
699482|NCT01856530|P1|Participant Flow|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699483|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699932|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699457|NCT01856673|P3|Participant Flow|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
699458|NCT01856673|P2|Participant Flow|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
699459|NCT01856673|P1|Participant Flow|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
699500|NCT01856361|P2|Participant Flow|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699460|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
699461|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
699462|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
699463|NCT01856673|O3|Outcome|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
699464|NCT01856673|O2|Outcome|ARM 2: Narrative Community Group Therapy|"Narrative Community Group Therapy (NCGT) only~Narrative Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity."
699520|NCT01856322|P1|Participant Flow|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
699465|NCT01856673|O1|Outcome|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
699466|NCT01856673|E3|Reported Event|ARM 3: Standby Group|"Standby group without intervention, but under monthly monitoring.~Standby group: Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; then an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center."
699467|NCT01856673|E2|Reported Event|ARM 2: Community Group Therapy|"Community Group Therapy (CGT) only~Community Therapy Intervention: It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by MHCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. MHCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the MHCW. Finally, session closes with a motivating activity."
699501|NCT01856361|P1|Participant Flow|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699956|NCT01854645|P1|Participant Flow|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699468|NCT01856673|E1|Reported Event|ARM 1: Common Elements Treatment Approach|"Common Elements Treatment Approach (CETA) only~Common Elements Treatment Approach: It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among victimized population by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Mental Health Community Workers (MHCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team."
699469|NCT01856569|B1|Baseline|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699470|NCT01856569|P1|Participant Flow|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699471|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699472|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699473|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699474|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699475|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699476|NCT01856569|O1|Outcome|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699477|NCT01856569|E1|Reported Event|Anti-Tumor Necrosis Factor (Anti-TNF)|Participants with ankylosing spondylitis (AS), who had started the anti-TNF-alpha treatment (as per physician’s discretion based on summary of product characteristics) for at least 12 months prior to enrollment, were followed up to 18 months.
699478|NCT01856530|B3|Baseline|Total|Total of all reporting groups
699479|NCT01856530|B2|Baseline|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699480|NCT01856530|B1|Baseline|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699481|NCT01856530|P2|Participant Flow|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699521|NCT01856322|O2|Outcome|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
699484|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699485|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699486|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699487|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699488|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699489|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699490|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699491|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699492|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699493|NCT01856530|O2|Outcome|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699494|NCT01856530|O1|Outcome|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699495|NCT01856530|E2|Reported Event|Placebo|"Matched placebo nasal spray~Placebo: Matched placebo nasal spray"
699496|NCT01856530|E1|Reported Event|Oxytocin|"Liquid intranasal oxytocin, 24 IU, administered once~Oxytocin: Liquid metered-dose nasal spray, 24 IU, administered once"
699497|NCT01856361|B3|Baseline|Total|Total of all reporting groups
699498|NCT01856361|B2|Baseline|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699499|NCT01856361|B1|Baseline|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699579|NCT01855958|B3|Baseline|Total|Total of all reporting groups
699957|NCT01854645|O5|Outcome|Placebo|Placebo MDI
699502|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699503|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699504|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699505|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699506|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699507|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699508|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699509|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699510|NCT01856361|O2|Outcome|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699511|NCT01856361|O1|Outcome|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699512|NCT01856361|E2|Reported Event|Placebo|"The placebo group will get a similar pill that will be started at visit 2, week zero of the study. Subjects will be asked to double the dose by taking two pills during visit 3, four weeks into the study, for a total of 32 weeks.~Placebo: Placebo pill that will match the treatment pill"
699513|NCT01856361|E1|Reported Event|Ramipril|"The initial dose of ramipril will be 2.5 mg that will be started at visit 2, week zero of the study. The dose will be increased to 5 mg during visit 3, 4 weeks into the study, for a total of 32 weeks.~Ramipril: Angiotensin Converting Enzyme Inhibitor"
699514|NCT01856322|B4|Baseline|Total|Total of all reporting groups
699515|NCT01856322|B3|Baseline|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
699516|NCT01856322|B2|Baseline|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
699517|NCT01856322|B1|Baseline|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
699518|NCT01856322|P3|Participant Flow|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
699519|NCT01856322|P2|Participant Flow|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
699523|NCT01856322|E3|Reported Event|Normal Volunteers (or Control Group)|Normal volunteers (or control group) enrolled with the only purpose to validate assays and the shipping method.
699524|NCT01856322|E2|Reported Event|Placebo|"one tablet twice daily~Placebo: One tablet twice daily"
699525|NCT01856322|E1|Reported Event|Sulindac|"one tablet twice daily~Sulindac: one tablet twice daily"
699526|NCT01855997|B1|Baseline|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699527|NCT01855997|P1|Participant Flow|Adult Participants Treated With Peg-IFN|Adult participants with hepatitis B envelope antigen (HBeAg)-positive or -negative chronic hepatitis B (CHB) infection who completed greater than or equal to (≥) 24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699528|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699529|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699602|NCT01855945|B11|Baseline|A/H3N2C + MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699530|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699531|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699532|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699533|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699534|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699535|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699536|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699537|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699538|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699539|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699540|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699541|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699542|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699543|NCT01855997|O1|Outcome|HBeAg-Positive Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699544|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699545|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699603|NCT01855945|B10|Baseline|A/H3N2C + 1/2 MF59 : ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699958|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699546|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699547|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699548|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699549|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699550|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699551|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699552|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699553|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699554|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699555|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699572|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699556|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699557|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699558|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699559|NCT01855997|O1|Outcome|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699560|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699561|NCT01855997|O1|Outcome|Adult CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699604|NCT01855945|B9|Baseline|A/H3N2C : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699562|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699563|NCT01855997|O1|Outcome|Adult Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-positive or -negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699564|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699565|NCT01855997|O1|Outcome|HBeAg-Negative Participants Treated With Peg-IFN|Adult participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699566|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699567|NCT01855997|O1|Outcome|HBeAg-Negative CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699568|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699569|NCT01855997|O1|Outcome|HBeAg-Negative Non-CN Participants Treated With Peg-IFN|Adult non-East Asian participants with HBeAg-negative CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699570|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699571|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699933|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699573|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699574|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699575|NCT01855997|O1|Outcome|HBeAg-Positive Participants Treated With Peg-IFN|Adult participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699576|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699577|NCT01855997|O1|Outcome|HBeAg-Positive CN Participants Treated With Peg-IFN|Adult East Asian participants with HBeAg-positive CHB infection who completed ≥24 weeks of Peg-IFN alfa-2a (alone or in combination with nucleos[t]ide analogues) therapy and ≥24 weeks of post-treatment follow-up were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699578|NCT01855997|E1|Reported Event|Adult Participants Treated With Peg-IFN|Adult participants with HBeAg-positive or -negative CHB infection, and who had completed at least 24 weeks of Peg-IFN alfa-2a with/without nucleoside analogue therapy and at least 24 weeks of follow-up, were included. Participants were recruited from Roche clinical trials or general practice; no treatment was administered in this non-interventional study.
699580|NCT01855958|B2|Baseline|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699581|NCT01855958|B1|Baseline|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699582|NCT01855958|P2|Participant Flow|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699583|NCT01855958|P1|Participant Flow|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699584|NCT01855958|O2|Outcome|Placebo-sham|"The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.~Placebo-sham: Electro acupuncture with rubber electrodes, without current passing."
699585|NCT01855958|O1|Outcome|DIMST|"The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterior; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.~DIMST: The investigators used electro acupuncture of 2 Hz during 30 minutes."
699623|NCT01855945|P2|Participant Flow|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699624|NCT01855945|P1|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699586|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699587|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699588|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699589|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699605|NCT01855945|B8|Baseline|A/H3N2C + MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699959|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699590|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699591|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699592|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699593|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699594|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699595|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699934|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
699596|NCT01855958|O2|Outcome|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699597|NCT01855958|O1|Outcome|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699598|NCT01855958|E2|Reported Event|Placebo-sham, Rubber Electrodes With Electrostimulation|The investigators used the same electro acupuncture device (Cosmotron, Sao Paulo, Brazil), which was previously set to prevent the current to pass through the electrodes. Subjects were informed that it would be a stimulus of low intensity and high frequency that they probably would not have any sense of it. The electrodes were placed on the same points where the active stimulation was applied while the nerve stimulation unit was left in front of the subject, for 30 minutes. This positioning ensured that the intermittent diode simulating the electrical stimulus was visible and audible.
699599|NCT01855958|E1|Reported Event|DIMST, Deep Intramuscular Stimulation Therapy|The investigators used acupuncture needles with guide tubes (Suzhou Huanqiu Acupuncture Medical Appliance Co. Ltd., 218, China) that were 40 mm in length and 0.25 mm in diameter. The needling in DIMST was applied using an electro acupuncture device (Cosmotron, São Paulo, Brazil) in the dermatomes corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). DIMST using was administered maintaining a distance from the spinous process line of 2 cm. The anatomic sites of peripheral DIMST were the muscles vastus medialis, rectus femoris, vastus lateralis, tibialis anterioris; and the pes anserinus bursae. All subjects received one 30min session using a frequency of 2 Hz.
699600|NCT01855945|B13|Baseline|Total|Total of all reporting groups
699601|NCT01855945|B12|Baseline|A/H3N2C : ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699960|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699606|NCT01855945|B7|Baseline|A/H3N2C + 1/2 MF59 : 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699607|NCT01855945|B6|Baseline|A/H3N2C : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699608|NCT01855945|B5|Baseline|A/H3N2C + MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699609|NCT01855945|B4|Baseline|A/H3N2C + 1/2 MF59 : 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699610|NCT01855945|B3|Baseline|A/H3N2C : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699611|NCT01855945|B2|Baseline|A/H3N2C + MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699612|NCT01855945|B1|Baseline|A/H3N2C + 1/2 MF59 : 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699613|NCT01855945|P12|Participant Flow|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699614|NCT01855945|P11|Participant Flow|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699615|NCT01855945|P10|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699616|NCT01855945|P9|Participant Flow|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699617|NCT01855945|P8|Participant Flow|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699618|NCT01855945|P7|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699619|NCT01855945|P6|Participant Flow|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699620|NCT01855945|P5|Participant Flow|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699621|NCT01855945|P4|Participant Flow|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699622|NCT01855945|P3|Participant Flow|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699821|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699625|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699626|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699627|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699628|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699629|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699630|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699631|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699632|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699633|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699634|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699635|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699636|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699638|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699639|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699640|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699641|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699642|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699643|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699644|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699645|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699646|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699647|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699648|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699649|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699650|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699651|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699652|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699653|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699654|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699655|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699656|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
700080|NCT01854047|B6|Baseline|Total|Total of all reporting groups
699657|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699658|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699659|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699660|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699661|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699662|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699663|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥61 YEARS|Subjects ≥61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699664|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699665|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699666|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <61 YEARS|Subjects 18 to <61 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699667|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699668|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699669|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699670|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699671|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699672|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699673|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699674|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699675|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699676|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699677|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699678|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699679|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699680|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699681|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699682|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699683|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699684|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699685|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699686|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699687|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699688|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699689|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699690|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699691|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699692|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699693|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699694|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699695|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699696|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699697|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699698|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699699|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699700|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699701|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699702|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699703|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699704|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699705|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699706|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699707|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699708|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699709|NCT01855945|O12|Outcome|A/H3N2C Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699710|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699711|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699712|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699713|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699714|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699715|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699716|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699717|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699718|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699719|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699720|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699721|NCT01855945|O12|Outcome|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699722|NCT01855945|O11|Outcome|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699723|NCT01855945|O10|Outcome|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699724|NCT01855945|O9|Outcome|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699725|NCT01855945|O8|Outcome|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699726|NCT01855945|O7|Outcome|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699727|NCT01855945|O6|Outcome|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699728|NCT01855945|O5|Outcome|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699729|NCT01855945|O4|Outcome|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699730|NCT01855945|O3|Outcome|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699731|NCT01855945|O2|Outcome|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699732|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699733|NCT01855945|O3|Outcome|A/H3N2C - Age Group: ≥65 YEARS|Subjects ≥65 years old Received two injections of cell-culture derived H3N2c vaccine, each dose containing 15 µg H3N2c antigen.
699734|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
699735|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: ≥65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699736|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old Received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699737|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699738|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699739|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699740|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699741|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59 Subjects 3 to <9 years.
699742|NCT01855945|O3|Outcome|A/H3N2C - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699743|NCT01855945|O2|Outcome|A/H3N2C + MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg antigen adjuvanted with full dose MF59.
699744|NCT01855945|O1|Outcome|A/H3N2C + 1/2 MF59 - Age Group: 3 TO <9 YEARS|Subjects, 3 to < 9 years old, received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75 µg antigen adjuvanted with half dose MF59.
699745|NCT01855945|E12|Reported Event|A/H3N2C Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699746|NCT01855945|E11|Reported Event|A/H3N2C + MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699747|NCT01855945|E10|Reported Event|A/H3N2C + 1/2 MF59 Age Group: >=65 YEARS|Subjects ≥65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699748|NCT01855945|E9|Reported Event|A/H3N2C Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699749|NCT01855945|E8|Reported Event|A/H3N2C + MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699750|NCT01855945|E7|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 18 TO <65 YEARS|Subjects 18 to <65 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699751|NCT01855945|E6|Reported Event|A/H3N2C Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699752|NCT01855945|E5|Reported Event|A/H3N2C + MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699753|NCT01855945|E4|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 9 TO <18 YEARS|Subjects 9 to <18 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699754|NCT01855945|E3|Reported Event|A/H3N2C Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of a non-adjuvanted cell-culture derived H3N2c vaccine, each dose containing 15 µg antigen.
699755|NCT01855945|E2|Reported Event|A/H3N2C + MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 7.5 µg H3N2c antigen adjuvanted with full dose MF59.
699756|NCT01855945|E1|Reported Event|A/H3N2C + 1/2 MF59 Age Group: 3 TO <9 YEARS|Subjects 3 to <9 years old received two injections of cell-culture derived H3N2c vaccine, each dose containing 3.75µg antigen adjuvanted with half dose MF59.
699757|NCT01855919|B3|Baseline|Total|Total of all reporting groups
699758|NCT01855919|B2|Baseline|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699759|NCT01855919|B1|Baseline|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699760|NCT01855919|P2|Participant Flow|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699761|NCT01855919|P1|Participant Flow|Duloxetine|Duloxetine 20 milligram (mg) during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699762|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
701292|NCT01846741|O4|Outcome|6-Month Visit|Users' Overall Assessment of Device Usability
699763|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699764|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699765|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699766|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699767|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699768|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699769|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699770|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699771|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 milligram (mg) for first week, 40 mg for second week and 60 mg for next 12 weeks administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during the last week.
699772|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699773|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699774|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699775|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699776|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699777|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699778|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699779|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699780|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699781|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699782|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699783|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699784|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699785|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699786|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699787|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699788|NCT01855919|O2|Outcome|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699789|NCT01855919|O1|Outcome|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699790|NCT01855919|E2|Reported Event|Placebo|Placebo administered in capsule form orally once every day for 15 weeks.
699791|NCT01855919|E1|Reported Event|Duloxetine|Duloxetine 20 mg during Week 1, 40 mg during Week 2, and 60 mg during Weeks 3 to 14 administered in capsule form orally once daily. Tapering doses of 40 mg for first 3 days and 20 mg for last 4 days were administered during Week 15.
699792|NCT01855074|B1|Baseline|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699793|NCT01855074|P1|Participant Flow|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699794|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699795|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699796|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699797|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699798|NCT01855074|O1|Outcome|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699800|NCT01855074|E1|Reported Event|Risperidone|Risperidone 25 milligram (mg) was administered as intramuscular injection (injection of a substance into a muscle) every 2 weeks up to 6 months
699801|NCT01854944|B4|Baseline|Total|Total of all reporting groups
699802|NCT01854944|B3|Baseline|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699803|NCT01854944|B2|Baseline|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699804|NCT01854944|B1|Baseline|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699805|NCT01854944|P3|Participant Flow|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699806|NCT01854944|P2|Participant Flow|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699807|NCT01854944|P1|Participant Flow|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1 milligram (mg) tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699808|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699809|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699810|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699811|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699812|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699813|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699814|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699815|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699816|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699817|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699818|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699819|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699820|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699822|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699823|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699824|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699825|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699826|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699827|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699828|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699829|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699830|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699831|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699832|NCT01854944|O3|Outcome|Cohort 3 Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699833|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699834|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699835|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699836|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699837|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699838|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699839|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699840|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699841|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699842|NCT01854944|O2|Outcome|Cohort 2- Brexpiprazole 1mg|Participants in cohort 2 received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699843|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in cohort 1 received 1-mg of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699844|NCT01854944|O3|Outcome|Cohort 3 - Brexpiprazole 4 mg|Participants in Cohort 3 received one 1- to 4-mg dose of brexpiprazole (at the investigator’s discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699845|NCT01854944|O2|Outcome|Cohort 2 - Brexpiprazole 1mg|Participants in Cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699846|NCT01854944|O1|Outcome|Cohort 1 - Brexpiprazole 4mg|Participants in Cohort 1 received 1-mg tablet of brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699847|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants in cohort 3 received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699848|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699849|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699850|NCT01854944|O1|Outcome|Brexpiprazole 4mg|Participants received 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699851|NCT01854944|O2|Outcome|Brexpiprazole 4 mg|Participants received 1-mg brexpiprazole once daily on Days 1 to 3 and 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699852|NCT01854944|O1|Outcome|Brexpiprazole 1mg|Participants received 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699853|NCT01854944|E3|Reported Event|Cohort 3 - Brexpiprazole 4 mg|Participants in cohort 3 received once 1- to 4-mg dose of brexpiprazole (at the study physician's discretion) once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699854|NCT01854944|E2|Reported Event|Cohort 2 - Brexpiprazole 1 mg|Participants in cohort 2 received one 1-mg tablet of brexpiprazole once daily on Days 1 to 10.
699855|NCT01854944|E1|Reported Event|Cohort 1 - Brexpiprazole 4 mg|Participants in cohort 1 received one 1-mg of brexpiprazole once daily on Days 1 to 3 and one 4-mg tablet of brexpiprazole once daily on Days 4 to 10.
699856|NCT01854905|B1|Baseline|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
699857|NCT01854905|P1|Participant Flow|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
699858|NCT01854905|O1|Outcome|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
699859|NCT01854905|E1|Reported Event|Patients Attending Consultation for LASIK|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
699860|NCT01854697|B6|Baseline|Total|Total of all reporting groups
699861|NCT01854697|B5|Baseline|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699862|NCT01854697|B4|Baseline|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699863|NCT01854697|B3|Baseline|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699864|NCT01854697|B2|Baseline|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699865|NCT01854697|B1|Baseline|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699866|NCT01854697|P5|Participant Flow|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699867|NCT01854697|P4|Participant Flow|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699868|NCT01854697|P3|Participant Flow|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699961|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699962|NCT01854645|O5|Outcome|Placebo|Placebo MDI
699869|NCT01854697|P2|Participant Flow|Arm B: TPV/PR in GT1a|Telaprevir (TPV) 750 mg every 8 hours (q8h) and pegylated interferon (pegIFN) 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699870|NCT01854697|P1|Participant Flow|Arm A: 3-DAA + RBV in GT1a|ABT-450/ritonavir (r)/ABT-267 150 mg/100 mg/25 mg once daily (QD) and ABT-333 250 mg twice daily (BID) and weight-based ribavirin (RBV) for 12 weeks (3 Direct-Acting Antivirals (DAAs) with RBV in genotype [GT] 1a)
699871|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699872|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699873|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699874|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699875|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699876|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699877|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699878|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699879|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699880|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699881|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699882|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699883|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699884|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699885|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699886|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699887|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699888|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699889|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699890|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699891|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699892|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699893|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699894|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699895|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699896|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699897|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699898|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699899|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699900|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699901|NCT01854697|O5|Outcome|Arm E: TPV/PR in GT1b|Telaprevir 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1b)
699902|NCT01854697|O4|Outcome|Arm D: 3-DAA in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks (3 DAAs without RBV in GT1b)
699903|NCT01854697|O3|Outcome|Arm C: 3-DAA + RBV in GT1b|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1b)
699904|NCT01854697|O2|Outcome|Arm B: TPV/PR in GT1a|TPV 750 mg q8h and pegIFN 180 µg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir (telaprevir with pegIFN/RBV in GT1a)
699905|NCT01854697|O1|Outcome|Arm A: 3-DAA + RBV in GT1a|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks (3 DAAs with RBV in GT1a)
699906|NCT01854697|E3|Reported Event|TPV + PEGIFN + RBV|TPV 750 mg q8h and pegIFN 180 μg/week and weight-based RBV for 12 weeks followed by an additional 12 or 36 weeks of pegIFN and weight based RBV according to response guided therapy per the prescribing information for telaprevir
699907|NCT01854697|E2|Reported Event|3 DAA|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID for 12 weeks
699908|NCT01854697|E1|Reported Event|3 DAA + RBV|ABT-450/r/ABT-267 150 mg/100 mg/25 mg QD and ABT-333 250 mg BID and weight-based RBV for 12 weeks
699909|NCT01854658|B5|Baseline|Total|Total of all reporting groups
699910|NCT01854658|B4|Baseline|Placebo MDI|Inhaled placebo administered as two puffs BID
699911|NCT01854658|B3|Baseline|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699912|NCT01854658|B2|Baseline|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699913|NCT01854658|B1|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699914|NCT01854658|P4|Participant Flow|Placebo MDI|Inhaled placebo administered as two puffs BID
699915|NCT01854658|P3|Participant Flow|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699916|NCT01854658|P2|Participant Flow|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699917|NCT01854658|P1|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699918|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
699919|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699920|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699921|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699922|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
699923|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699924|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699925|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699926|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
699927|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699928|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699929|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699935|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699936|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699937|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699938|NCT01854658|O4|Outcome|Placebo MDI|Inhaled placebo administered as two puffs BID
699939|NCT01854658|O3|Outcome|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699940|NCT01854658|O2|Outcome|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699941|NCT01854658|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699942|NCT01854658|E4|Reported Event|Placebo MDI|Inhaled placebo administered as two puffs BID
699943|NCT01854658|E3|Reported Event|GFF MDI (PT003)|GFF MDI 14.4/9.6 mcg administered as two puffs BID
699944|NCT01854658|E2|Reported Event|GP MDI (PT001)|GP MDI 14.4 mcg administered as two puffs BID
699945|NCT01854658|E1|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg administered as two puffs BID
699946|NCT01854645|B6|Baseline|Total|Total of all reporting groups
699947|NCT01854645|B5|Baseline|Placebo|Placebo MDI
699948|NCT01854645|B4|Baseline|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699949|NCT01854645|B3|Baseline|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699950|NCT01854645|B2|Baseline|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699951|NCT01854645|B1|Baseline|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699952|NCT01854645|P5|Participant Flow|Placebo|Placebo MDI
699953|NCT01854645|P4|Participant Flow|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699954|NCT01854645|P3|Participant Flow|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699955|NCT01854645|P2|Participant Flow|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699971|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699972|NCT01854645|O5|Outcome|Placebo|Placebo MDI
699973|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699974|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699975|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699976|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699977|NCT01854645|O5|Outcome|Placebo|Placebo MDI
699978|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699979|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699980|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699981|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699982|NCT01854645|O5|Outcome|Placebo|Placebo MDI
699983|NCT01854645|O4|Outcome|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699984|NCT01854645|O3|Outcome|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699985|NCT01854645|O2|Outcome|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699986|NCT01854645|O1|Outcome|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699987|NCT01854645|E5|Reported Event|Placebo|Placebo MDI
699988|NCT01854645|E4|Reported Event|Spiriva® Handihaler® (Open-label)|Open-label tiotropium bromide inhalation powder 18 mcg
699989|NCT01854645|E3|Reported Event|FF MDI (PT005)|Formoterol Fumarate (FF) MDI 9.6 mcg
699990|NCT01854645|E2|Reported Event|GP MDI (PT001)|Glycopyrronium (GP) MDI 14.4 mcg
699991|NCT01854645|E1|Reported Event|GFF MDI (PT003)|Glycopyrronium Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) 14.4/9.6 mcg
699992|NCT01854632|B3|Baseline|Total|Total of all reporting groups
699993|NCT01854632|B2|Baseline|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
699994|NCT01854632|B1|Baseline|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
699995|NCT01854632|P2|Participant Flow|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
699996|NCT01854632|P1|Participant Flow|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
699997|NCT01854632|O2|Outcome|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
699998|NCT01854632|O1|Outcome|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
699999|NCT01854632|E2|Reported Event|Placebo|Single dose of placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
700000|NCT01854632|E1|Reported Event|Vaccine|Single dose of trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
700001|NCT01854593|B3|Baseline|Total|Total of all reporting groups
700002|NCT01854593|B2|Baseline|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
700003|NCT01854593|B1|Baseline|Bevacizumab and Vitrectomy|"0.16 mg/0.05 ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700004|NCT01854593|P2|Participant Flow|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Sham injection: Sham injection one day before vitrectomy~Vitrectomy: vitrectomy of 25 gauge system."
700005|NCT01854593|P1|Participant Flow|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700006|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700007|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700008|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700009|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700010|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700011|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700012|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700013|NCT01854593|O1|Outcome|Bevacizumab Injection and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700014|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700015|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700016|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700017|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700018|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700019|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700020|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700021|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700022|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700023|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700024|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700025|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700026|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700027|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700028|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700029|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700030|NCT01854593|O2|Outcome|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700031|NCT01854593|O1|Outcome|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700032|NCT01854593|E2|Reported Event|Sham Injection and Vitrectomy|"Sham injection one day before operation and vitrectomy.~Vitrectomy: vitrectomy of 25 gauge system.~Sham injection: Sham injection one day before vitrectomy"
700033|NCT01854593|E1|Reported Event|Bevacizumab and Vitrectomy|"0.16mg/0.05ml bevacizumab intravitreal injection one day before surgery and vitrectomy.~Bevacizumab: 0.16mg/0.05ml bevacizumab (single injection on 1 day before operation)~Vitrectomy: vitrectomy of 25 gauge system."
700034|NCT01854528|B3|Baseline|Total|Total of all reporting groups
700035|NCT01854528|B2|Baseline|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700036|NCT01854528|B1|Baseline|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700037|NCT01854528|P2|Participant Flow|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700038|NCT01854528|P1|Participant Flow|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700039|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700040|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700041|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700042|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700043|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700044|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700045|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700046|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700047|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700048|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700049|NCT01854528|O2|Outcome|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700050|NCT01854528|O1|Outcome|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700051|NCT01854528|E2|Reported Event|TPV/RBV|TPV (750 mg every 8 hours) coadministered with pegIFN (180 micrograms subcutaneously [SC] weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks, followed by pegIFN (180 micrograms SC weekly) and weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for either 12 or 36 weeks, per local prescribing information.
700052|NCT01854528|E1|Reported Event|3-DAA/RBV|3-DAA (ABT-450/r/ABT-267 [150 mg/ 100 mg/ 25 mg once daily] and ABT-333 [250 mg twice daily]) plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks.
700053|NCT01854281|B5|Baseline|Total|Total of all reporting groups
700054|NCT01854281|B4|Baseline|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
700055|NCT01854281|B3|Baseline|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
700056|NCT01854281|B2|Baseline|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
700057|NCT01854281|B1|Baseline|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
700058|NCT01854281|P4|Participant Flow|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after Dive B.
700059|NCT01854281|P3|Participant Flow|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
700060|NCT01854281|P2|Participant Flow|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after Dive A.
700061|NCT01854281|P1|Participant Flow|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
700062|NCT01854281|O4|Outcome|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
700063|NCT01854281|O3|Outcome|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
700064|NCT01854281|O2|Outcome|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
700065|NCT01854281|O1|Outcome|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
700066|NCT01854281|E4|Reported Event|Patent Foramen Ovale Dive B Group|Divers with a previously diagnosed patent foramen ovale observed after dive B.
700067|NCT01854281|E3|Reported Event|Closure Dive B Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive B.
700068|NCT01854281|E2|Reported Event|Patent Foramen Ovale Dive A Group|Divers with a previously diagnosed patent foramen ovale observed after dive A.
700069|NCT01854281|E1|Reported Event|Closure Dive A Group|Divers with a patent foramen ovale previously closed by a catheter-based procedure observed after Dive A.
700087|NCT01854047|P4|Participant Flow|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700088|NCT01854047|P3|Participant Flow|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
701293|NCT01846741|O3|Outcome|EMU Discharge|Users' Overall Assessment of Device Usability
700070|NCT01854268|B1|Baseline|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators will first place cotton elastic bands around your chest and abdomen so that measures of chest wall and abdominal movements can be measured. Forced vital capacity and rest breathing maneuvers were completed.~Nebulized water (Fog): The investigators will provide you with nebulized water (FOG) through the facemask for up to a minute three times. A minute break in between each presentation."
700071|NCT01854268|P1|Participant Flow|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in the chest wall and abdomen during cough. Participants breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. Participants received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants rested for a minute in between each presentation and water was available at all times.~Pulmonary function testing: Investigators placed cotton elastic bands around the chest and abdomen so that measures of chest wall and abdominal movements could be measured. Forced vital capacity and rest breathing was completed.~Nebulized water (Fog): The investigators provided nebulized water (FOG) through the facemask for up to a minute three times. A minute break was allotted between each presentation."
700072|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
700073|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
700074|NCT01854268|O1|Outcome|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults who receive capsaicin: Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times."
700075|NCT01854268|E1|Reported Event|Healthy Adults Who Receive Capsaicin|"Single treatment consisting of healthy adults.~Healthy adults received capsaicin: Participants were seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant breathed through a facemask attached to a pneumotachograph, nebulizer, and dosimeter. The participant received 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants had a minute in between each presentation and water will be available at all times."
700076|NCT01854242|B1|Baseline|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
700077|NCT01854242|P1|Participant Flow|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
700078|NCT01854242|O1|Outcome|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
700079|NCT01854242|E1|Reported Event|Glycogen Storage Disease Type Ia Patients|The participants will have one blood draw for this study. The test will be performed on the blood.
700081|NCT01854047|B5|Baseline|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700082|NCT01854047|B4|Baseline|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700083|NCT01854047|B3|Baseline|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700084|NCT01854047|B2|Baseline|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700085|NCT01854047|B1|Baseline|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700086|NCT01854047|P5|Participant Flow|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700415|NCT01853072|E4|Reported Event|Posttreatment|All participants after cessation of study treatment up to study exit
700089|NCT01854047|P2|Participant Flow|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700090|NCT01854047|P1|Participant Flow|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable inhaled corticosteroid/ long-acting beta-agonist (ICS/LABA) therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700091|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700092|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700093|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700094|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700095|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700096|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700097|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700098|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700099|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700100|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700101|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700102|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700207|NCT01854047|E4|Reported Event|Dupilumab 300 mg q4w|Participants exposed to Dupilumab 300 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
700103|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700104|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700105|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700106|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700107|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700108|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700109|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700110|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700111|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700112|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700113|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700114|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700115|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700116|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700117|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700118|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700119|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700120|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700121|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700122|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700123|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700259|NCT01853605|P1|Participant Flow|Augmentation|Women undergoing breast augmentation.
700124|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700125|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700126|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700127|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700128|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700129|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700130|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700279|NCT01853475|B1|Baseline|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700131|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700132|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700133|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700134|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700135|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700136|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700137|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700138|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700139|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700140|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700141|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700142|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700143|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700208|NCT01854047|E3|Reported Event|Dupilumab 200 mg q2w|Participants exposed to Dupilumab 200 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
700762|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
700144|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700145|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700146|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700147|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700148|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700149|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700150|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700151|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700152|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700153|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700154|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700155|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700156|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700157|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700158|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700159|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700160|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700161|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700162|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700163|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700164|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700260|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
700165|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700166|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700167|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700168|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700169|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700170|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700171|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700172|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700173|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700174|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700175|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700176|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700177|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700178|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700179|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700180|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700181|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700182|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700183|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700184|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700185|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700209|NCT01854047|E2|Reported Event|Dupilumab 300 mg q2w|Participants exposed to Dupilumab 300 mg q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
700186|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700187|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700188|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700189|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700190|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700191|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700192|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700193|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700416|NCT01853072|E3|Reported Event|Vehicle|All participants treated with NepafenacVehicle during the course of study treatment
700194|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700195|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700196|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700197|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700198|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700199|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700200|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700201|NCT01854047|O5|Outcome|Dupilumab 200 mg q4w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 200 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700202|NCT01854047|O4|Outcome|Dupilumab 300 mg q4w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1) followed by a Placebo alternating with single 300 mg injection of Dupilumab q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700203|NCT01854047|O3|Outcome|Dupilumab 200 mg q2w|2 subcutaneous injections of Dupilumab 200 mg (for a total of 400 mg) as a loading dose on Day 1 (Week 1), followed by a single 200 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700204|NCT01854047|O2|Outcome|Dupilumab 300 mg q2w|2 subcutaneous injections of Dupilumab 300 mg (for a total of 600 mg) as a loading dose on Day 1 (Week 1), followed by a single 300 mg injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700205|NCT01854047|O1|Outcome|Placebo q2w|2 subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 (Week 1) followed by a single injection q2w from Week 2 to Week 22 added to stable ICS/LABA therapy. Salbutamol/albuterol or Levosalbutamol/levalbuterol was given as reliever medication.
700206|NCT01854047|E5|Reported Event|Dupilumab 200 mg q4w|Participants exposed to Dupilumab 200 mg alternating with placebo q2w added to stable ICS/LABA therapy (mean exposure of 23 weeks).
700261|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
700210|NCT01854047|E1|Reported Event|Placebo|Participants exposed to Placebo (for Dupilumab) added to stable ICS/LABA therapy (mean exposure of 23 weeks).
700211|NCT01853982|B3|Baseline|Total|Total of all reporting groups
700212|NCT01853982|B2|Baseline|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
700213|NCT01853982|B1|Baseline|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
700214|NCT01853982|P2|Participant Flow|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
700215|NCT01853982|P1|Participant Flow|Ceftolozane/Tazobactam|3000 milligrams (mg) ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered intravenously (IV), every 8 hours for 8 days
700216|NCT01853982|O2|Outcome|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
700217|NCT01853982|O1|Outcome|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
700218|NCT01853982|E2|Reported Event|Piperacillin/Tazobactam|4500 mg piperacillin/tazobactam (comprised of 4000 mg piperacillin and 500 mg tazobactam), administered IV, every 6 hours for 8 days
700219|NCT01853982|E1|Reported Event|Ceftolozane/Tazobactam|3000 mg ceftolozane/tazobactam (comprised of 2000 mg ceftolozane and 1000 mg tazobactam), administered IV, every 8 hours for 8 days
700220|NCT01853839|B1|Baseline|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
700221|NCT01853839|P1|Participant Flow|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
700222|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700223|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700224|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
700225|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
700226|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
700227|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
700228|NCT01853839|O2|Outcome|Internist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a internist."
700229|NCT01853839|O1|Outcome|Cardiologist|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients whose primary physician was a cardiologist."
700230|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700256|NCT01853605|P4|Participant Flow|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
700257|NCT01853605|P3|Participant Flow|Reconstruction|Women undergoing breast reconstruction.
700258|NCT01853605|P2|Participant Flow|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
700231|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700232|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700233|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700234|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700235|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700236|NCT01853839|O2|Outcome|Non-Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did not fast for Ramadan."
700280|NCT01853475|P3|Participant Flow|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
700417|NCT01853072|E2|Reported Event|Nepafenac|All participants treated with Nepafenac during the course of study treatment
700237|NCT01853839|O1|Outcome|Fasting|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks. Patients who did fast for Ramadan."
700238|NCT01853839|O1|Outcome|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~Treatment duration is up to 52 weeks."
700239|NCT01853839|E1|Reported Event|All Subjects|"Newly diagnosed or uncontrolled adult hypertensive patients with at least one cardiovascular risk factor who are prescribed antihypertensive drugs with an approved indication for cardiovascular protection (including Micardis® 80 mg/ Micardis® Plus tablets) as monotherapy or as part of a combination regimen with other antihypertensive agents.~All antihypertensive drugs will be prescribed and administered according to the approved prescribing information in the country where the patient resides. Treatment duration is up to 52 weeks."
700240|NCT01853696|B3|Baseline|Total|Total of all reporting groups
700241|NCT01853696|B2|Baseline|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
700242|NCT01853696|B1|Baseline|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate"
700243|NCT01853696|P2|Participant Flow|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
700244|NCT01853696|P1|Participant Flow|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
700245|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
700246|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
700247|NCT01853696|O2|Outcome|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
700248|NCT01853696|O1|Outcome|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
700249|NCT01853696|E2|Reported Event|Prednisolone Acetate|"Prednisolone acetate 1% ophthalmic solution applied 4 times daily for two months, 3 times daily for one month, twice daily for one month, and once daily for 7 months~prednisolone acetate 1%"
700250|NCT01853696|E1|Reported Event|Loteprednol|"Loteprednol etabonate 0.5% gel applied topically 4 times daily for 2 months, 3 times daily for 1 month, twice daily for one month and once daily for 7 months~loteprednol etabonate 0.5% gel"
700251|NCT01853605|B5|Baseline|Total|Total of all reporting groups
700252|NCT01853605|B4|Baseline|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
700253|NCT01853605|B3|Baseline|Reconstruction|Women undergoing breast reconstruction.
700254|NCT01853605|B2|Baseline|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
700255|NCT01853605|B1|Baseline|Augmentation|Women undergoing breast augmentation.
700262|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
700263|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
700264|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
700265|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
700266|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
700267|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
700268|NCT01853605|O4|Outcome|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
700269|NCT01853605|O3|Outcome|Reconstruction|Women undergoing breast reconstruction.
700270|NCT01853605|O2|Outcome|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
700271|NCT01853605|O1|Outcome|Augmentation|Women undergoing breast augmentation.
700272|NCT01853605|E4|Reported Event|Revision-Reconstruction|Women undergoing revision of previous breast reconstruction.
700273|NCT01853605|E3|Reported Event|Reconstruction|Women undergoing breast reconstruction.
700274|NCT01853605|E2|Reported Event|Revision-Augmentation|Women undergoing revision of previous breast augmentation.
700275|NCT01853605|E1|Reported Event|Augmentation|Women undergoing breast augmentation.
700276|NCT01853475|B4|Baseline|Total|Total of all reporting groups
700277|NCT01853475|B3|Baseline|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
700278|NCT01853475|B2|Baseline|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
701294|NCT01846741|O2|Outcome|EMU Day-1|Users' Overall Assessment of Device Usability
700281|NCT01853475|P2|Participant Flow|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700282|NCT01853475|P1|Participant Flow|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700283|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
700284|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700285|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700286|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
700287|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700288|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700289|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
700290|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700291|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700292|NCT01853475|O3|Outcome|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
700293|NCT01853475|O2|Outcome|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700294|NCT01853475|O1|Outcome|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700295|NCT01853475|E3|Reported Event|Treatment C - PQP 1440mg & OZ439 PIB 800mg|PQP Tablets 1440 mg and OZ439 PIB 800mg + full fat cow's milk
700296|NCT01853475|E2|Reported Event|Treatment B: PQP 960mg & OZ439+TPGS 800mg|PQP tablets 960mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700297|NCT01853475|E1|Reported Event|Treatment A: PQP 1440mg & OZ439+TPGS 800mg|PQP tablets 1440mg and OZ439+TPGS 800mg co-administered as a single oral dose fasted.
700298|NCT01853397|B5|Baseline|Total|Total of all reporting groups
700299|NCT01853397|B4|Baseline|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700300|NCT01853397|B3|Baseline|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700301|NCT01853397|B2|Baseline|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700302|NCT01853397|B1|Baseline|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700303|NCT01853397|P4|Participant Flow|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700304|NCT01853397|P3|Participant Flow|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700305|NCT01853397|P2|Participant Flow|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700306|NCT01853397|P1|Participant Flow|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700307|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700308|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700309|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700310|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700311|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700312|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700313|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700314|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700315|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700316|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700317|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700318|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700319|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700320|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700321|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700322|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700323|NCT01853397|O4|Outcome|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700324|NCT01853397|O3|Outcome|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700325|NCT01853397|O2|Outcome|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700326|NCT01853397|O1|Outcome|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700327|NCT01853397|E4|Reported Event|Treatment With 3 Passes at 60 J/cm2|"Single treatment with Liposonix System (Model 2) using grid repeat technique with 3 passes at 60 J/cm2 (180 J/cm2 total fluence)~Liposonix System (Model 2)"
700328|NCT01853397|E3|Reported Event|Treatment at Level 3|"Single treatment with Liposonix System (Model 2)using single pass technique at level 3 (120 J/cm2)~Liposonix System (Model 2)"
700329|NCT01853397|E2|Reported Event|Treatment at Level 2|"Single treatment with Liposonix System (Model 2)using the single pass technique at treatment level 2 (140 J/cm2)~Liposonix System (Model 2)"
700330|NCT01853397|E1|Reported Event|Treatment at Level 1|"Single treatment with Liposonix System (Model 2) using single pass technique at level 1 (180 J/cm2)~Liposonix System (Model 2)"
700331|NCT01853384|B3|Baseline|Total|Total of all reporting groups
700332|NCT01853384|B2|Baseline|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700333|NCT01853384|B1|Baseline|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700334|NCT01853384|P2|Participant Flow|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700335|NCT01853384|P1|Participant Flow|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700336|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700387|NCT01853085|B1|Baseline|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700763|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
700337|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700338|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700339|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700340|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700365|NCT01853254|O1|Outcome|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
700369|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
700341|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700342|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700343|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700344|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700345|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700346|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700347|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700348|NCT01853384|O2|Outcome|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700388|NCT01853085|P1|Participant Flow|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700639|NCT01851876|E1|Reported Event|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
700349|NCT01853384|O1|Outcome|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700350|NCT01853384|E2|Reported Event|HP802-247 Vehicle Plus Compression Therapy|"fibrinogen solution & thrombin solution without cells. Subjects randomized to HP802-247 Vehicle will receive Vehicle weekly for up to 12 weeks or wound closure, which ever occurred first.~HP802-247 Vehicle: HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface."
700351|NCT01853384|E1|Reported Event|HP802-247 Plus Compression Therapy|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days for up to 12 weeks or wound closure, which ever occurred first. Subjects randomized to HP802-247 will receive Vehicle on alternate weeks.~HP802-247: Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days."
700352|NCT01853371|B3|Baseline|Total|Total of all reporting groups
700353|NCT01853371|B2|Baseline|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
700366|NCT01853254|E1|Reported Event|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
700367|NCT01853215|B1|Baseline|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
700368|NCT01853215|P1|Participant Flow|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
700399|NCT01853072|B2|Baseline|Vehicle|Nepafenac Ophthalmic Suspension Vehicle
700354|NCT01853371|B1|Baseline|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
700355|NCT01853371|P2|Participant Flow|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
700356|NCT01853371|P1|Participant Flow|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other. The wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
700357|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
700358|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
700359|NCT01853371|O2|Outcome|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
700360|NCT01853371|O1|Outcome|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
700361|NCT01853371|E2|Reported Event|Conventional Treatment|"Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital."
700362|NCT01853371|E1|Reported Event|Wet Cupping and Conventional Treatment|"Wet cupping: Will be administered through 3 sessions, with 4 weeks interval between each session and the other.~Conventional treatment: Is the usual anti-HTN treatment taken by the patients at the King Abdulaziz university hospital outpatient department.~Wet cupping: Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.~Conventional treatment: According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment."
700363|NCT01853254|B1|Baseline|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
700364|NCT01853254|P1|Participant Flow|Peginterferon Alfa-2a Monotherapy or Combined With Ribavirin|The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
700400|NCT01853072|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.3%
700370|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
700371|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
700372|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
700373|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
700374|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
700375|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System: intraosseous catheter for use in the sternum"
700376|NCT01853215|O1|Outcome|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N.~T.A.L.O.N. Intraosseous System : intraosseous catheter for use in the sternum"
700377|NCT01853215|E1|Reported Event|Sternal Intraosseous Vascular Access|"sternal intraosseous vascular access using T.A.L.O.N. Sternal Manual Intraosseous Needle set~T.A.L.O.N. Sternal Manual Intraosseous Needle set : intraosseous catheter for use in the sternum"
700378|NCT01853176|B3|Baseline|Total|Total of all reporting groups
700379|NCT01853176|B2|Baseline|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
700380|NCT01853176|B1|Baseline|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
700381|NCT01853176|P2|Participant Flow|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
700382|NCT01853176|P1|Participant Flow|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
700383|NCT01853176|O2|Outcome|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
700384|NCT01853176|O1|Outcome|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
700385|NCT01853176|E2|Reported Event|Standard Bupivicaine|"Patients will receive the maximum safe allowance of 0.25% bupivacaine, or 1.5 mg/kg (eg. 150 mg or 60 mL for a 100 kg patient) infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Standard bupivicaine"
700386|NCT01853176|E1|Reported Event|Liposomal Injection Bupivicaine (Exparel)|"Patients will have the maximum approved dose of Exparel, 266 mg, diluted in 20 mL normal saline, infiltrated into the rectus fascia and subcutaneous tissues at the time of abdominoplasty.~Liposomal Injection Bupivacaine (Exparel)"
700640|NCT01851863|B5|Baseline|Total|Total of all reporting groups
700389|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700390|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700391|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700392|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700393|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700394|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700395|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700396|NCT01853085|O1|Outcome|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700397|NCT01853085|E1|Reported Event|Patients With POAG or OHT|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
700398|NCT01853072|B3|Baseline|Total|Total of all reporting groups
700418|NCT01853072|E1|Reported Event|Pretreatment|All participants who consented to participate in the study prior to the initiation of study treatment
700419|NCT01853046|B3|Baseline|Total|Total of all reporting groups
700420|NCT01853046|B2|Baseline|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700421|NCT01853046|B1|Baseline|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700422|NCT01853046|P2|Participant Flow|Regorafenib (Stivarga, BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700423|NCT01853046|P1|Participant Flow|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700424|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700425|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700426|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700427|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700428|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700429|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700430|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700431|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700432|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700433|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700434|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700490|NCT01852825|B1|Baseline|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700435|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700436|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700437|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700438|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700439|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700440|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700441|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700442|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700443|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700444|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700479|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
700445|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700446|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700447|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700448|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700449|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700450|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700515|NCT01852812|B4|Baseline|Total|Total of all reporting groups
700516|NCT01852812|B3|Baseline|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700451|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700452|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700453|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700454|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700455|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700456|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700457|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700458|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700459|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700460|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700461|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700462|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700463|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700464|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700465|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days
700466|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700517|NCT01852812|B2|Baseline|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700467|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700468|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700469|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700470|NCT01853046|O2|Outcome|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700471|NCT01853046|O1|Outcome|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Renal Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700472|NCT01853046|E2|Reported Event|Regorafenib(Stivarga,BAY73-4506)-Severe Renal Impairment|Participants with severe renal impairment received Regorafenib 160 mg o.d. as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700473|NCT01853046|E1|Reported Event|Regorafenib(Stivarga, BAY73-4506)-Normal/Mild Impairment|Participants with normal/mild renal impairment received Regorafenib 160 mg o.d.as a single dose in Stage 1, Day 1 with a washout of at least 5 days, followed by multiple dosing in an intermittent administration schedule (3 week on / 1 week off) over 2 cycles in Stage 2 (56 days). Cycle 2 started immediately after Cycle 1. A Cycle for this study is defined as 28 days.
700474|NCT01852955|B3|Baseline|Total|Total of all reporting groups
700475|NCT01852955|B2|Baseline|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
700476|NCT01852955|B1|Baseline|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
700477|NCT01852955|P2|Participant Flow|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
700478|NCT01852955|P1|Participant Flow|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
700641|NCT01851863|B4|Baseline|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
700480|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
700481|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
700482|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
700483|NCT01852955|O2|Outcome|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
700484|NCT01852955|O1|Outcome|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
700485|NCT01852955|E2|Reported Event|Placebo|"Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen~Placebo: Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen"
700486|NCT01852955|E1|Reported Event|IV Acetaminophen|"Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure.~IV acetaminophen: Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure"
700487|NCT01852825|B4|Baseline|Total|Total of all reporting groups
700488|NCT01852825|B3|Baseline|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700489|NCT01852825|B2|Baseline|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700491|NCT01852825|P3|Participant Flow|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700492|NCT01852825|P2|Participant Flow|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700493|NCT01852825|P1|Participant Flow|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700494|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700495|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700496|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700497|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700498|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700499|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700500|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700501|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700502|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700503|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700504|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700505|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700764|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
700506|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700507|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700508|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700509|NCT01852825|O3|Outcome|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700510|NCT01852825|O2|Outcome|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700511|NCT01852825|O1|Outcome|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700512|NCT01852825|E3|Reported Event|NAC + Placebo (Part 2)|NAC treatment consisting of 1800 BU of HDM extract on Days -14, 56 and 84; starting on Day 1 a single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700513|NCT01852825|E2|Reported Event|NAC + MK-8237 (Part 2)|Nasal Allergen Challenge (NAC) treatment consisting of 1800 Biological Units (BU) of HDM extract on Days -14, 56 and 84; starting on Day 1 a single tablet of MK-8237 with 12 Development Units (DUs), administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
700514|NCT01852825|E1|Reported Event|NAC (Part 1)|Nasal Allergen Challenge (NAC) treatment consisting of 100 µl fixed volume of 10,000 biological units (BU) of HDM extract delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1
700518|NCT01852812|B1|Baseline|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700519|NCT01852812|P3|Participant Flow|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700520|NCT01852812|P2|Participant Flow|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg chewable tablets (CT) in one tablet PO QD at bed time for 12 weeks
700521|NCT01852812|P1|Participant Flow|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg oral granules (OG) in one sachet orally (PO) once daily (QD) at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700522|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700523|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700524|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700525|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700526|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700527|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700528|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700529|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700530|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700531|NCT01852812|O3|Outcome|Montelukast 5 mg CT/10-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700532|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-9 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700533|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700534|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700535|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700536|NCT01852812|O2|Outcome|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700537|NCT01852812|O1|Outcome|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700538|NCT01852812|E2|Reported Event|Montelukast 5 mg CT/6-15 Year Olds|Participants receive montelukast 5 mg CT in one tablet PO QD at bed time for 12 weeks
700539|NCT01852812|E1|Reported Event|Montelukast 4 mg OG/1-5 Year Olds|Participants receive montelukast 4 mg OG in one sachet PO QD at bed time for 4 weeks with an option to continue for an additional 8 weeks (12 weeks total)
700540|NCT01852669|B3|Baseline|Total|Total of all reporting groups
700541|NCT01852669|B2|Baseline|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700542|NCT01852669|B1|Baseline|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700543|NCT01852669|P2|Participant Flow|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700544|NCT01852669|P1|Participant Flow|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700545|NCT01852669|O2|Outcome|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700546|NCT01852669|O1|Outcome|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700547|NCT01852669|E2|Reported Event|ESWL, Hydration|"ESWL with hydration~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700548|NCT01852669|E1|Reported Event|Inversion, Hydration, ESWL|"ESWL with hydration and inversion~Inversion: Patients inverted 30 degree head down in Trendelenburg position~Shock Wave Lithotripsy: Shock wave lithotripsy~Hydration: Hydration of patient with 0.5L NaCl and 20mg frusemide IV"
700549|NCT01852591|B1|Baseline|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
700550|NCT01852591|P1|Participant Flow|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
700551|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
700552|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
700553|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
700554|NCT01852591|O1|Outcome|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
700555|NCT01852591|E1|Reported Event|Experimental: PCV 13|Pneumococcal conjugate vaccine (PCV 13), 0.5ml, 3 to 30 days prior to transplant and then again at 7-10 and 21-24 days after transplant.
700556|NCT01852383|B1|Baseline|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
700557|NCT01852383|P1|Participant Flow|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
700558|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.~Administration was as a single a.m. dose.~Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
700559|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects.~Administration was as a single a.m. dose.~Duloxetine: Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale, Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale."
700560|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
700634|NCT01851876|P2|Participant Flow|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
700561|NCT01852383|O1|Outcome|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
700562|NCT01852383|E1|Reported Event|Duloxetine|"A minimum 1-week psychotropic medication washout, and a washout of 3 weeks for fluoxetine and monoamine oxidase inhibitors(MAOIs), was required. Duloxetine was prescribed at 20 mg daily for the first week, 30 mg daily for the second week, then 60 mg daily for another 4 weeks. Patients could subsequently be raised to 90 mg daily for another 2-4 weeks and then to a maximum dose of 120 mg daily.~At all visits, the study psychiatrist had the option of adjusting the dose based on clinical response and side effects. Dose increments at these specified time-points will not occur if the patient meets criteria for remission or develops intolerable side effects that require reducing the dose or stopping the medication.~Administration will be as a single a.m. dose."
700563|NCT01852214|B1|Baseline|Overall Population|Subjects with type 2 diabetes mellitus and coronary artery disease
700564|NCT01852214|P2|Participant Flow|Ticagrelor First, Then Prasugrel|"Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose~Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose"
700565|NCT01852214|P1|Participant Flow|Prasugrel First, Then Ticagrelor|"Prasugrel: Patients randomized to prasugrel will be treated with 60mg loading dose and 10mg maintenance dose~Ticagrelor: Patients randomized to ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose"
700566|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
700567|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
700568|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
700569|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
700570|NCT01852214|O2|Outcome|Ticagrelor|Patients received 180mg loading dose and 90mg bid maintenance dose
700571|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
700572|NCT01852214|O2|Outcome|Ticagrelor|Patients received a 180mg loading dose and 90mg bid maintenance dose
700573|NCT01852214|O1|Outcome|Prasugrel|Patients received 60mg loading dose and 10mg maintenance dose
700574|NCT01852214|E2|Reported Event|Safety Population: Patients Receiving Ticagrelor|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
700575|NCT01852214|E1|Reported Event|Safety Population: Patients Receiving Prasugrel|Safety analyses were conducted on the safety population, which included all patients exposed to at least one dose of the study drug, and are reported according to the intervention received at the time the adverse event occurred.
700576|NCT01852175|B3|Baseline|Total|Total of all reporting groups
700577|NCT01852175|B2|Baseline|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
700578|NCT01852175|B1|Baseline|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
700579|NCT01852175|P2|Participant Flow|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
700580|NCT01852175|P1|Participant Flow|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
700581|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
700582|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
700583|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
700584|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
700585|NCT01852175|O2|Outcome|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
700586|NCT01852175|O1|Outcome|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
700587|NCT01852175|E2|Reported Event|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
700588|NCT01852175|E1|Reported Event|Prasugrel|Prasugrel 60mg loading dose and 10 mg maintenance dose
700589|NCT01852162|B3|Baseline|Total|Total of all reporting groups
700590|NCT01852162|B2|Baseline|Placebo|Placebo tablets
700591|NCT01852162|B1|Baseline|Dabigatran|Dabigatran 150mg tablets
700592|NCT01852162|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received matching placebo tablets twice/daily for 7 (±3) days.
700593|NCT01852162|P1|Participant Flow|Dabigatran|Patients randomized to the dabigatran arm received dabigatran 150mg twice/daily for 7 (±3) days.
700594|NCT01852162|O2|Outcome|Placebo|Placebo tablets
700595|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
700596|NCT01852162|O2|Outcome|Placebo|Placebo tablets
700597|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
700598|NCT01852162|O2|Outcome|Placebo|Placebo tablets
700599|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
700600|NCT01852162|O2|Outcome|Placebo|Placebo tablets
700601|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
700602|NCT01852162|O2|Outcome|Placebo|Placebo tablets
700603|NCT01852162|O1|Outcome|Dabigatran|Dabigatran 150mg
700604|NCT01852162|E2|Reported Event|Placebo|Placebo tablets
700605|NCT01852162|E1|Reported Event|Dabigatran|Dabigatran 150mg tablets
700606|NCT01852019|B3|Baseline|Total|Total of all reporting groups
700635|NCT01851876|P1|Participant Flow|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
700636|NCT01851876|O2|Outcome|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
700607|NCT01852019|B2|Baseline|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700608|NCT01852019|B1|Baseline|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700609|NCT01852019|P5|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel discontinued 24h prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700610|NCT01852019|P4|Participant Flow|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel discontinued 48h (n=6) prior to initiation of cangrelor infusion (2h)~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700611|NCT01852019|P3|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700648|NCT01851863|P1|Participant Flow|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
701295|NCT01846741|O1|Outcome|Implant/Recovery|Users' Overall Assessment of Device Usability
700612|NCT01852019|P2|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700613|NCT01852019|P1|Participant Flow|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion|"Cangrelor IV + Oral prasugrel (60mg) administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV is administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects will receive prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700614|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700615|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700616|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700617|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700637|NCT01851876|O1|Outcome|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
700638|NCT01851876|E2|Reported Event|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
700618|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700619|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700620|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700621|NCT01852019|O2|Outcome|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV iwas administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700622|NCT01852019|O1|Outcome|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700623|NCT01852019|O3|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) a 1.0h|"Cangrelor IV + oral prasugrel (60mg) were administered at 1.0h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700649|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
700958|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700624|NCT01852019|O2|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) at 1.5h|"Cangrelor IV + oral prasugrel (60mg) was administered at 1.5h after the cangrelor infusion start time.~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700625|NCT01852019|O1|Outcome|Day 1 - Cangrelor + Prasugrel (60mg) Post Infusion (2.0h)|"Cangrelor IV + Oral prasugrel (60mg) were administered within 5 minutes after cangrelor IV discontinuation~cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.~Subjects were given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
700626|NCT01852019|E5|Reported Event|Day 8 - Prasugrel (10mg) Dosing (5 Doses)|"Prasugrel was discontinued 48h prior to initiation of cangrelor infusion (2h)~Subjects were given 5 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
700627|NCT01852019|E4|Reported Event|Day 8 - Prasugrel (10mg) Dosing (6 Doses)|"Prasugrel was discontinued 24h prior to initiation of cangrelor infusion (2h)~Subjects were given 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8.~Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8"
700628|NCT01852019|E3|Reported Event|Day 1 - Prasugrel (60mg) - Post Infusion (2.0 hr)|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) post infusion, [at 2.0 hrs, (within 5 minutes of discontinuing the cangrelor infusion)]."
700629|NCT01852019|E2|Reported Event|Day 1 - Prasugrel (60mg) at 1.0 hr|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.0 hour after infusion start)."
700630|NCT01852019|E1|Reported Event|Day 1 - Prasugrel (60mg) at 1.5 Hrs|"Cangrelor: Cangrelor IV was administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8~Prasugrel: Day 1: Subjects received prasugrel (60 mg) during the initial cangrelor infusion (at 1.5 hours after infusion start)."
700631|NCT01851876|B3|Baseline|Total|Total of all reporting groups
700632|NCT01851876|B2|Baseline|No Endometrial Injury|The patients in this group will not be subjected to endometrial injury procedure in presiding IVF cycle. The patients will be stimulated with standard IVF protocol.
700633|NCT01851876|B1|Baseline|Endometrial Injury|The patients in this group will be subjected to endometrial injury procedure in preceding IVF cycle.
700642|NCT01851863|B3|Baseline|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
700643|NCT01851863|B2|Baseline|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
700644|NCT01851863|B1|Baseline|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
700645|NCT01851863|P4|Participant Flow|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
700646|NCT01851863|P3|Participant Flow|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
700647|NCT01851863|P2|Participant Flow|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
700673|NCT01851772|E1|Reported Event|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
700650|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
700651|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
700652|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
700653|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
700654|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
700655|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
700656|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
700657|NCT01851863|O4|Outcome|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
700658|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
700659|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
700660|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole) .The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
700661|NCT01851863|O3|Outcome|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
700662|NCT01851863|O2|Outcome|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole).The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
700663|NCT01851863|O1|Outcome|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
700664|NCT01851863|E4|Reported Event|Proton Pump Inhibitor|"Prescribe Omeprazole.~Omeprazole: Prescribe Omeprazole(20mg, po, qd, 30min before breakfast)."
700665|NCT01851863|E3|Reported Event|Deanxit(Without Explanation) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
700666|NCT01851863|E2|Reported Event|Deanxit(Psychological) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
700667|NCT01851863|E1|Reported Event|Deanxit(Psychological and GI) + Omeprazole|Prescribe antidepressant drug(Flupentixol and Melitracen Tablets) and proton pump inhibitor(Omeprazole). The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
700668|NCT01851772|B1|Baseline|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
700669|NCT01851772|P1|Participant Flow|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
700670|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
700671|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
700672|NCT01851772|O1|Outcome|Treatment|Subjects were treated with 80-90 Gy total treatment dose over 4-6 fractions.
700675|NCT01851655|B2|Baseline|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700676|NCT01851655|B1|Baseline|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700677|NCT01851655|P2|Participant Flow|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700678|NCT01851655|P1|Participant Flow|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700679|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700680|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700708|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
700765|NCT01849588|O1|Outcome|Treatment Arm|"Sorafenib taken orally twice per day~Sorafenib"
700681|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700682|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700683|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700722|NCT01851330|B2|Baseline|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700723|NCT01851330|B1|Baseline|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700724|NCT01851330|P3|Participant Flow|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700959|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
700684|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700685|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700686|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700687|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700688|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700689|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700690|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700691|NCT01851655|O2|Outcome|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700692|NCT01851655|O1|Outcome|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700725|NCT01851330|P2|Participant Flow|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700726|NCT01851330|P1|Participant Flow|LDV/SOF 8 Week|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 8 weeks
700727|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
701296|NCT01846741|O1|Outcome|Number of Subjects|Experienced Adverse Events Greater Than 5% Incidence
700693|NCT01851655|E2|Reported Event|Plyometric Exercise - Low Intensity|"A lower peak vertical ground reaction force will be generated in the low intensity group compared to the high intensity group based on findings in the literature (e.g. lower box heights, only two-legged jumps, lower percent effort)~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700694|NCT01851655|E1|Reported Event|Plyometric Exercise - High Intensity|"The exercises should produce a higher peak vertical ground reaction force than those in the low group based on literature findings (e.g. single leg jumps, jumps from higher heights, higher percent effort).~Plyometric Exercise: Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each)."
700695|NCT01851590|B4|Baseline|Total|Total of all reporting groups
700696|NCT01851590|B3|Baseline|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
700697|NCT01851590|B2|Baseline|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine Lacquer is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700698|NCT01851590|B1|Baseline|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700699|NCT01851590|P3|Participant Flow|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine: Terbinafine 250 mg was administered orally once a day for 3 months in toenail onychomycosis."
700700|NCT01851590|P2|Participant Flow|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine: Amorolfine was administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700701|NCT01851590|P1|Participant Flow|Resin Lacquer Arm|"Topical treatment: 30 % Resin Lacquer (Abicin®)~Resin Lacquer was administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700702|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
700703|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700704|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700705|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
700706|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700707|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700709|NCT01851590|O2|Outcome|Amorolfine Treatment Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700710|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700711|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
700712|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700713|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700714|NCT01851590|O3|Outcome|Terbinafine Arm|"Oral medication with 250 mg Terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
700715|NCT01851590|O2|Outcome|Amorolfine Lacquer Arm|"Topical treatment with 5 % Amorolfine Lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700716|NCT01851590|O1|Outcome|Resin Lacquer Arm|"Topical treatment with 30 % Resin Lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700717|NCT01851590|E3|Reported Event|Terbinafine Arm|"Oral medication with 250 mg terbinafine / day~Terbinafine 250 mg is administered orally once a day for 3 months in toenail onychomycosis."
700718|NCT01851590|E2|Reported Event|Amorolfine Lacquer Arm|"Topical treatment with 5 % amorolfine lacquer (Loceryl®)~Amorolfine is administered locally in the form of lacquer (Loceryl®) onto infected nail once a week for 9 months in toenail onychomycosis."
700719|NCT01851590|E1|Reported Event|Resin Lacquer Arm|"Topical treatment with 30 % resin lacquer (Abicin®)~Resin is administered locally in the form of lacquer (Abicin®) onto infected nail once a day for 9 months in toenail onychomycosis."
700720|NCT01851330|B4|Baseline|Total|Total of all reporting groups
700728|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700729|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700730|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700731|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700732|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700733|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700734|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700735|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700736|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700737|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700738|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700739|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700740|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700741|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700742|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700743|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700744|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700745|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700746|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700747|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700748|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700749|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700750|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700751|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700752|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700753|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700754|NCT01851330|O3|Outcome|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700755|NCT01851330|O2|Outcome|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700756|NCT01851330|O1|Outcome|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700757|NCT01851330|E3|Reported Event|LDV/SOF 12 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
700758|NCT01851330|E2|Reported Event|LDV/SOF+RBV 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000 or 1200 mg daily based on weight) for 8 weeks
700759|NCT01851330|E1|Reported Event|LDV/SOF 8 Week|LDV 90 mg/SOF 400 mg FDC tablet once daily for 8 weeks
700760|NCT01849588|B1|Baseline|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
700761|NCT01849588|P1|Participant Flow|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
700766|NCT01849588|E1|Reported Event|Sorafenib|"Sorafenib taken orally twice per day~Sorafenib"
700767|NCT01849562|B4|Baseline|Total|Total of all reporting groups
700768|NCT01849562|B3|Baseline|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
700769|NCT01849562|B2|Baseline|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700770|NCT01849562|B1|Baseline|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700771|NCT01849562|P3|Participant Flow|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
700772|NCT01849562|P2|Participant Flow|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700773|NCT01849562|P1|Participant Flow|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700774|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
700775|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-2000mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700776|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700777|NCT01849562|O3|Outcome|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
700778|NCT01849562|O2|Outcome|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700779|NCT01849562|O1|Outcome|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700780|NCT01849562|E3|Reported Event|Placebo|"Placebo for Sovaprevir capsule QD + placebo for ACH-3102 150 mg loading dose on Day 1 followed by 50 mg capsule QD + placebo for weight-based RBV QD for 12 weeks~Placebo"
700781|NCT01849562|E2|Reported Event|Sovaprevir 400 mg, ACH-3102 150/50mg, RBV 1000-1200mg|"Sovaprevir 400 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700782|NCT01849562|E1|Reported Event|Sovaprevir 200 mg, ACH-3102 150/50 mg, RBV 1000-1200mg|"Sovaprevir 200 mg QD + ACH-3102 150 mg loading dose on Day 1 followed by 50 mg QD + RBV weight-based 1000-1200mg QD for 12 weeks~Sovaprevir: NS3/4A protease inhibitor~ACH-3102: NS5A inhibitor~Ribavirin"
700783|NCT01849497|B3|Baseline|Total|Total of all reporting groups
700784|NCT01849497|B2|Baseline|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
700785|NCT01849497|B1|Baseline|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
700786|NCT01849497|P2|Participant Flow|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen). Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4.
700787|NCT01849497|P1|Participant Flow|Evolocumab PFS|"Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).~Participants self-administered evolocumab in the clinic on Day 1 under supervision and then self-administered in a home setting at Weeks 2 and 4."
700788|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
700789|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
700790|NCT01849497|O2|Outcome|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
700791|NCT01849497|O1|Outcome|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
700792|NCT01849497|E2|Reported Event|Evolocumab AI/Pen|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled autoinjector/pen (AI/pen).
700793|NCT01849497|E1|Reported Event|Evolocumab PFS|Participants received evolocumab 140 mg every 2 weeks for 4 weeks (Day 1, Week 2, and Week 4) subcutaneously using a prefilled syringe (PFS).
700823|NCT01850589|B1|Baseline|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
700930|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700794|NCT01849419|B1|Baseline|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
700795|NCT01849419|P1|Participant Flow|Single Group|"Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.~This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg), oxytocin (20 IU), and placebo over the course of four experimental sessions. Drug order was randomized for each participant."
700796|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700797|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700798|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700799|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700800|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700801|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700802|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700803|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700804|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700805|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700806|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
701297|NCT01846741|O1|Outcome|VNS Therapy|ITT Population
700807|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700808|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700809|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700810|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700811|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700812|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700813|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700814|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700815|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700816|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
700817|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
700818|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
700819|NCT01849419|O1|Outcome|Single Group|Healthy volunteers received all drug conditions/interventions (MDMA, oxytocin, and placebo) using a within-subjects design. Drug order was randomized.
700820|NCT01849419|E1|Reported Event|Single Group|"Healthy volunteers received all drug conditions including placebo (within-subjects design).~Within-subjects (MDMA and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received MDMA (0.75, 1.5 mg/kg)and placebo. Participants received oxytocin as an active control on one session (see second Intervention).~Within-subjects (oxytocin and placebo): This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session and placebo on one session. Participants received MDMA on the other two sessions (see first Intervention)."
700821|NCT01850589|B3|Baseline|Total|Total of all reporting groups
700822|NCT01850589|B2|Baseline|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
700838|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
700824|NCT01850589|P2|Participant Flow|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~8 one hour group counseling sessions focusing on patient education and behavior modification.~Behavior modifications include cue recognition; coping skills; stress management; and relapse prevention skills.~Counseling includes information on nutrition, exercise, and chemical dependency.~All counseling sessions will be held at 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer~Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
700825|NCT01850589|P1|Participant Flow|Conserative Therapy|"Patients will be counseled by the vascular attending/fellow during their office appointment to stop smoking. Counseling will consist of a self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
700826|NCT01850589|O2|Outcome|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
700827|NCT01850589|O1|Outcome|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
700849|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700960|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700828|NCT01850589|E2|Reported Event|Aggressive Therapy|"8 week comprehensive smoking cessation and pharmacotherapy program consisting of:~One hour group counseling sessions, focusing on patient education and behavior modification.~Behavior modifications including recognition; coping skills; stress management; and relapse prevention skills.~Counseling including information on nutrition, exercise, and chemical dependency.~Counseling sessions will be held 256C Mason Avenue. Pharmacotherapy adjuncts offered at no cost are as follows: Chantix (varenicline) GlaxoSmithKline, Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline.~Varenicline, Bupropion,and nicotine nasal spray, inhaler, transdermal patches and gum: Pharmacotherapy adjuncts offered at no cost are as follows:~Chantix (varenicline) GlaxoSmithKline,~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
700829|NCT01850589|E1|Reported Event|Conserative Therapy|"Patients counseled by the vascular attending/fellow during office appointment to stop smoking. Counseling consists of self-help materials including Smart Move: A Stop Smoking Guide from the American Cancer Society and a brief educational discussion on the benefits of smoking cessation. Patients randomized to Group 1 will be offered adjunctive treatment with nicotine replacement therapy at no cost."
700830|NCT01850550|B3|Baseline|Total|Total of all reporting groups
700831|NCT01850550|B2|Baseline|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
700832|NCT01850550|B1|Baseline|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
700833|NCT01850550|P2|Participant Flow|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
700834|NCT01850550|P1|Participant Flow|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
700835|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
700836|NCT01850550|O1|Outcome|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
700837|NCT01850550|O2|Outcome|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
700868|NCT01850394|P1|Participant Flow|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700839|NCT01850550|E2|Reported Event|Weight Loss Groups|"Participants in this arm will receive peer-led facilitation within groups using an adaptation of the Diabetes Prevention Program.~Weight loss Groups: The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions."
700840|NCT01850550|E1|Reported Event|Control|"Participants in the control condition will be given written information at the baseline visit from the NIH website Aim for a Healthy Weight to provide a basic understanding of weight loss and access to basic online resources, but will not participate in group weight loss sessions with peer leaders."
700841|NCT01850485|B3|Baseline|Total|Total of all reporting groups
700842|NCT01850485|B2|Baseline|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700843|NCT01850485|B1|Baseline|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700844|NCT01850485|P2|Participant Flow|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700845|NCT01850485|P1|Participant Flow|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700846|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700847|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700848|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700850|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700851|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700852|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700853|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700854|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700855|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700856|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700857|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700858|NCT01850485|O2|Outcome|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700859|NCT01850485|O1|Outcome|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700860|NCT01850485|E2|Reported Event|33 Degrees, Therapeutic Hypothermia|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700861|NCT01850485|E1|Reported Event|Normothermia, 36 Degrees|"microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees~microcirculation by SDF and NIRS, in 33 and 36 degrees: at baseline, after 12 and 24 hours in both arms"
700862|NCT01850394|B4|Baseline|Total|Total of all reporting groups
700863|NCT01850394|B3|Baseline|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700864|NCT01850394|B2|Baseline|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700865|NCT01850394|B1|Baseline|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700866|NCT01850394|P3|Participant Flow|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700867|NCT01850394|P2|Participant Flow|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700869|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700870|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700871|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700872|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700873|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700874|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700875|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700876|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700877|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700952|NCT01849692|P6|Participant Flow|Cohort 3 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
700953|NCT01849692|P5|Participant Flow|Cohort 3 - ESBA|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg)
700878|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700879|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700880|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700881|NCT01850394|O3|Outcome|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700882|NCT01850394|O2|Outcome|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700883|NCT01850394|O1|Outcome|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700884|NCT01850394|E3|Reported Event|TXA-500 Group|"A total of 25-ml solution with 500-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700885|NCT01850394|E2|Reported Event|TXA-250 Group|"A total of 25-ml solution with 250-mg tranexamic acid~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group~Tranexamic Acid : Inject tranexamic acid solution intra-articularly after fascia closure"
700886|NCT01850394|E1|Reported Event|Control Group|"physiologic saline 25 ml~Physiologic saline : Use physiologic saline for mixing with tranexamic acid or use alone in placebo group"
700887|NCT01849848|B1|Baseline|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700888|NCT01849848|P1|Participant Flow|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700889|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700890|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700891|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700928|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700929|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700892|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700893|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700894|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700895|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700896|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700897|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700954|NCT01849692|P4|Participant Flow|Cohort 2 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
700955|NCT01849692|P3|Participant Flow|Cohort 2 - ESBA|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg)
700956|NCT01849692|P2|Participant Flow|Cohort 1 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
700898|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700899|NCT01849848|O1|Outcome|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700900|NCT01849848|E1|Reported Event|SyB L-0501|SyB L-0501: The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
700901|NCT01849770|B4|Baseline|Total|Total of all reporting groups
700902|NCT01849770|B3|Baseline|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700903|NCT01849770|B2|Baseline|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700904|NCT01849770|B1|Baseline|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700905|NCT01849770|P3|Participant Flow|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700906|NCT01849770|P2|Participant Flow|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700907|NCT01849770|P1|Participant Flow|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700908|NCT01849770|O2|Outcome|900mg vs Placebo|
700909|NCT01849770|O1|Outcome|300mg vs Placebo|
700910|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700911|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700912|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700913|NCT01849770|O2|Outcome|900mg vs Placebo|
700914|NCT01849770|O1|Outcome|300mg vs Placebo|
700915|NCT01849770|O2|Outcome|900mg vs Placebo|
700916|NCT01849770|O1|Outcome|300mg vs Placebo|
700917|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700918|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700919|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700920|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700921|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700922|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700923|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700924|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700925|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700926|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700927|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700931|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700932|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700933|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700934|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700935|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700936|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700937|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700938|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700939|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700940|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700941|NCT01849770|O3|Outcome|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700942|NCT01849770|O2|Outcome|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700943|NCT01849770|O1|Outcome|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700944|NCT01849770|E3|Reported Event|Placebo|"Placebo, by mouth per day for 12 weeks.~Placebo"
700945|NCT01849770|E2|Reported Event|Mexiletine, 900 Milligrams|"Mexiletine, 900 milligrams by mouth per day for 12 weeks.~Mexiletine"
700946|NCT01849770|E1|Reported Event|Mexiletine, 300 Milligrams|"Mexiletine, 300 milligrams by mouth per day for 12 weeks.~Mexiletine"
700947|NCT01849692|B3|Baseline|Total|Total of all reporting groups
700948|NCT01849692|B2|Baseline|LUCENTIS|All subjects who were treated with LUCENTIS.
700949|NCT01849692|B1|Baseline|ESBA|All subjects who were treated with ESBA1008.
700950|NCT01849692|P8|Participant Flow|Cohort 4 - Ranibizumab|Ranibizumab 0.5 mg injection, Day 0 and Day 28
700951|NCT01849692|P7|Participant Flow|Cohort 4 - ESBA|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg)
700962|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700963|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg IVT infusion
700964|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700965|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg IVT injection
700966|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700967|NCT01849692|O1|Outcome|ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg IVT infusion
700968|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700969|NCT01849692|O1|Outcome|ESBA 0.6 mg INJ|All subjects treated with ESBA 1008 0.6 mg IVT injection
700970|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700971|NCT01849692|O1|Outcome|ESBA 1 mg INF|All subjects treated with ESBA 1008 1 mg IVT infusion
700972|NCT01849692|O2|Outcome|LUCENTIS 0.5 mg INJ|All subjects treated with Ranibizumab 0.5 mg IVT injection
700973|NCT01849692|O1|Outcome|ESBA 1.2 mg INJ|All subjects treated with ESBA 1008 1.2 mg IVT injection
700974|NCT01849692|O4|Outcome|Cohort 4|ESBA1008 solution Day 0 (0.5 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
700975|NCT01849692|O3|Outcome|Cohort 3|ESBA1008 solution Day 0 (0.6 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
700976|NCT01849692|O2|Outcome|Cohort 2|ESBA1008 solution Day 0 (1 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
700977|NCT01849692|O1|Outcome|Cohort 1|ESBA1008 solution Day 0 (1.2 mg) and Day 28 (6 mg), or Ranibizumab Day 0 and Day 28, based on randomization
700978|NCT01849692|E7|Reported Event|Pretreatment|All subjects who consented to participate in the study prior to the initiation of study treatment
700979|NCT01849692|E6|Reported Event|Stage 2 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 2
700980|NCT01849692|E5|Reported Event|Stage 2 ESBA 0.5 mg INF|All subjects treated with ESBA1008 0.5 mg via infusion
700981|NCT01849692|E4|Reported Event|Stage 2 ESBA 0.6 mg INJ|All subjects treated with ESBA1008 0.6 mg via injection
700982|NCT01849692|E3|Reported Event|Stage 1 LUCENTIS 0.5 mg INJ|All subjects treated with LUCENTIS via injection in Stage 1
700983|NCT01849692|E2|Reported Event|Stage 1 ESBA 1 mg INF|All subjects treated with ESBA1008 1 mg via infusion
700984|NCT01849692|E1|Reported Event|Stage 1 ESBA 1.2 mg INJ|All subjects treated with ESBA1008 1.2 mg via injection
700985|NCT01849289|B3|Baseline|Total|Total of all reporting groups
700986|NCT01849289|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700987|NCT01849289|B1|Baseline|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700988|NCT01849289|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
701007|NCT01849068|P2|Participant Flow|Placebo First, Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 10 mg/d for 12 weeks
700989|NCT01849289|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700990|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700991|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700992|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700993|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700994|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
701070|NCT01848899|P2|Participant Flow|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
700995|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700996|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700997|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700998|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
700999|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
701000|NCT01849289|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
701001|NCT01849289|O1|Outcome|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
701002|NCT01849289|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
701003|NCT01849289|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) 10U was injected subcutaneously (under the skin) once daily (OD) in the evening (start of main evening meal to bedtime) either in the thigh, upper arm (deltoid area) or abdomen along with metformin given orally for 26 weeks. At last treatment visit (Visit 28) subjects were instructed to switch basal insulin treatment to the intermediate acting insulin NPH until the follow-up visit (Visit 29).
701004|NCT01849068|B3|Baseline|Total|Total of all reporting groups
701005|NCT01849068|B2|Baseline|Placebo First Then Ezetimibe|First intervention: Placebo for 12 weeks Second intervention: Ezetimibe 12 weeks
701006|NCT01849068|B1|Baseline|Ezetimibe First Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo 12 weeks
701055|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701008|NCT01849068|P1|Participant Flow|Ezetimibe First, Then Placebo|First intervention: Ezetimibe 10 mg/d for 12 weeks Second intervention: Placebo for 12 weeks
701009|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
701010|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
701011|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
701012|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
701013|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
701014|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
701015|NCT01849068|O2|Outcome|Placebo|Placebo: Placebo for 12 weeks Placebo for 12 weeks
701016|NCT01849068|O1|Outcome|Ezetimibe|Ezetimibe: Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
701017|NCT01849068|E2|Reported Event|Placebo|Placebo for 12 weeks Placebo for 12 weeks
701018|NCT01849068|E1|Reported Event|Ezetimibe|Ezetimibe 10 mg/d for 12 weeks Ezetimibe 10 mg/d for 12 weeks
701019|NCT01848990|B4|Baseline|Total|Total of all reporting groups
701020|NCT01848990|B3|Baseline|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701021|NCT01848990|B2|Baseline|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701022|NCT01848990|B1|Baseline|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701071|NCT01848899|P1|Participant Flow|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
701023|NCT01848990|P3|Participant Flow|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701024|NCT01848990|P2|Participant Flow|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701025|NCT01848990|P1|Participant Flow|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous subcutaneous insulin infusion (CSII) (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 units (U) through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701026|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701027|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701028|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701029|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701030|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701031|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701032|NCT01848990|O2|Outcome|Standard Rapid-acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701033|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701034|NCT01848990|O2|Outcome|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting insulin CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701132|NCT01848210|E1|Reported Event|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
701522|NCT01846299|E2|Reported Event|Sham With Ranibizumab 0.5mg|Sham with Ranibizumab 0.5mg
701035|NCT01848990|O1|Outcome|Hylenex Recombinant|For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of Hylenex recombinant (either Formulation 1 or Formulation 2), delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701036|NCT01848990|E3|Reported Event|Standard Rapid-Acting Insulin CSII|Participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine) for 6 months.
701037|NCT01848990|E2|Reported Event|Precommercial Hylenex Recombinant (Formulation 2)|Hylenex Formulation 2: For 6 months, participants received their regular treatment of rapid-acting CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the precommercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701038|NCT01848990|E1|Reported Event|Commercial Hylenex Recombinant (Formulation 1)|Hylenex Formulation 1: For 6 months, participants received their regular treatment of rapid-acting continuous CSII (for example, insulin lispro, insulin aspart, and insulin glulisine). Additionally, during this 6-month treatment period, the participants received a pretreatment dose of the commercial form of Hylenex recombinant, delivered at 150 U through their insulin infusion cannula each time they changed infusion sets (every 2 to 3 days).
701039|NCT01848977|B1|Baseline|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
701072|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
701073|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
701074|NCT01848899|O2|Outcome|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
701075|NCT01848899|O1|Outcome|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
701040|NCT01848977|P1|Participant Flow|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
701041|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Reactive hyperemic area were calculated and compared to INVOS®.
701042|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Reactive hyperemic area were calculated and compared to InSpectra™ .
701043|NCT01848977|O2|Outcome|InSpectra™|Basline value before VOT,and minimum/ maximum values of InSpectra™ were obtained and compared to INVOS®.
701044|NCT01848977|O1|Outcome|INVOS®|Basline value before VOT,and minimum/ maximum values of INVOS® were obtained and compared to InSpectra™ .
701045|NCT01848977|O2|Outcome|InSpectra™|Data from InSpectra™ during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to INVOS®.
701046|NCT01848977|O1|Outcome|INVOS®|Data from INVOS® during VOT were manually recorded. Desaturation and reoxygenation rate were calculated and compared to InSpectra™ .
701047|NCT01848977|E1|Reported Event|Vascular Occlusion Test|"The pediatric SomaSensor™ probe of INVOS® and the 15-mm sensor of InSpectra™ are placed on each thenar muscle in the same subject. The side on which the probe will be placed is randomly determined. INVOS® updates data every 5 s and data (SrO2) will be manually recorded. The data of InSpectra™ (StO2) are automatically collected and sampled every 2 s.~Vascular occlusion test (VOT) is done as follows:Adult-size blood pressure cuffs are placed around each upper arm. The both cuffs are simultaneously inflated to 30 mmHg above the initial systolic blood pressure and kept inflated until the SrO2 or StO2 decreased to 40%. When the value reaches 40% or just below it, the cuff on the same side is deflated rapidly. The data will be collected until the SrO2 and StO2 values returned to the baseline."
701048|NCT01848938|B3|Baseline|Total|Total of all reporting groups
701049|NCT01848938|B2|Baseline|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701050|NCT01848938|B1|Baseline|Smartphone Treatment|"Smartphone treatment with pelvic floor muscle training (PFMT).~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701051|NCT01848938|P2|Participant Flow|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701052|NCT01848938|P1|Participant Flow|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701053|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701054|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701523|NCT01846299|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
701056|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701057|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701058|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701059|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701060|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701061|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701062|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701063|NCT01848938|O2|Outcome|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701064|NCT01848938|O1|Outcome|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701065|NCT01848938|E2|Reported Event|Waiting List|Waiting list for three months. They receive the smartphone application after follow-up.
701066|NCT01848938|E1|Reported Event|Smartphone Treatment|"Smartphone treatment with PFMT.~Smartphone treatment with PFMT: A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. Possibility to set reminders. The treatment period is three months"
701067|NCT01848899|B3|Baseline|Total|Total of all reporting groups
701082|NCT01848899|E2|Reported Event|Iodixanol Arm|Iodixanol: contrast media used during coronary angiography
701083|NCT01848899|E1|Reported Event|Ioxaglate Arm|Ioxaglate: contrast media used during coronary angiography
701084|NCT01848847|B3|Baseline|Total|Total of all reporting groups
701085|NCT01848847|B2|Baseline|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701086|NCT01848847|B1|Baseline|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701087|NCT01848847|P2|Participant Flow|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701088|NCT01848847|P1|Participant Flow|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701089|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701090|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701091|NCT01848847|O2|Outcome|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701092|NCT01848847|O1|Outcome|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701093|NCT01848847|E2|Reported Event|Full Bladder|"Hysteroscopy conducted under full bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701094|NCT01848847|E1|Reported Event|Empty Bladder|"Hysteroscopy conducted under empty bladder.~Hysteroscopy : bladder filling before diagnostic outpatient hysteroscopy"
701095|NCT01848756|B1|Baseline|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701096|NCT01848756|P1|Participant Flow|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701097|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701098|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701099|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701174|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701175|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701176|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701100|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701101|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
701102|NCT01848756|O1|Outcome|SNX-5422|SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
701103|NCT01848756|O1|Outcome|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701104|NCT01848756|E1|Reported Event|SNX-5422|"Open-label administration of SNX-5422 capsules to total 100 mg/m2 every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle. Subjects will continue treatment on a 28-day cycle at the discretion of the principal investigator based on safety.~SNX-5422: Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle."
701105|NCT01848366|B1|Baseline|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
701106|NCT01848366|P1|Participant Flow|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
701107|NCT01848366|O1|Outcome|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
701108|NCT01848366|E1|Reported Event|Biowave Treatment|"Twelve weekly treatments~Biowave Treatment: Twelve weekly treatments"
701109|NCT01848288|B1|Baseline|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
701110|NCT01848288|P1|Participant Flow|Overall|First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group.
701111|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
701112|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
701113|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
701114|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
701115|NCT01848288|O2|Outcome|INFINITI Vision System|INFINITI® Vision System randomly assigned to first surgical eye, with CENTURION® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
701116|NCT01848288|O1|Outcome|CENTURION Vision System|CENTURION® Vision System randomly assigned to first surgical eye, with INFINITI® Vision System assigned to second surgical eye (fellow eye). Each eye received a single treatment with estimated duration of less than 30 minutes. The second eye surgery occurred within 14 days of first eye surgery.
701117|NCT01848288|E1|Reported Event|Overall|"First surgical eye randomly assigned to CENTURION® Vision System or INFINITI® Vision System, with the second surgical eye (fellow eye) assigned to the alternative group. For non-ocular adverse events, at risk population is included with unit of subjects. For ocular adverse events, at risk population is included with unit of eyes by treatment group."
701118|NCT01848210|B3|Baseline|Total|Total of all reporting groups
701119|NCT01848210|B2|Baseline|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
701120|NCT01848210|B1|Baseline|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
701121|NCT01848210|P2|Participant Flow|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
701122|NCT01848210|P1|Participant Flow|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
701123|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
701124|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
701125|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
701126|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
701127|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
701128|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
701129|NCT01848210|O2|Outcome|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
701130|NCT01848210|O1|Outcome|Coumarin + Troxerutin|Coumarin 30 mg, troxerutin 180 mg fixed-dose combination tablets, orally, three times daily for up to 16 weeks.
701131|NCT01848210|E2|Reported Event|Placebo|Coumarin + troxerutin placebo-matching tablets, orally, three times daily for up to 16 weeks.
701177|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701133|NCT01848145|B1|Baseline|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal is to complete infusion #3 within 120 minutes (+/- 15 minutes).~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701134|NCT01848145|P1|Participant Flow|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. .~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701135|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701152|NCT01848054|O1|Outcome|BNX Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701153|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701136|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701137|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701138|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701139|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701178|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701179|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701180|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701181|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701182|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701140|NCT01848145|O1|Outcome|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701141|NCT01848145|E1|Reported Event|Ofatumumab Accelerated Infusion|"Ofatumumab administered by intravenous (IV) infusion. The goal infusion time at Infusion #3 is 120 minutes.~Infusion 1 (Week 1, Day 1): 300 mg IV starting at 3.6 mg/hr and doubling every 30 minutes until reaching a rate of 240 mg/hr. (Planned infusion time: 226 minutes) If tolerated, patients receive Infusion 2.~Infusion 2 (Week 1, Day 3): 1000 mg IV starting at 50 mg/hr and doubling every 30 min until reaching a rate of 80 mg/hr. (Planned infusion time: 167 minutes) If tolerated, patients receive Infusion 3.~Infusion 3 (Week 2, Day 1): 2000 mg IV, 20% to be given for 30 minutes and, if tolerated, the remaining 80% to be infused over the next 90 minutes. (Planned infusion time: 120 minutes)~Weeks 3-8: If 2000mg dose is tolerated, subsequent infusions will be given weekly in the same manner. Assessments will be done at week 12; responding patients can continue receiving the 2000 mg IV infusion monthly for 4 months up to week 28."
701142|NCT01848054|B3|Baseline|Total|Total of all reporting groups
701143|NCT01848054|B2|Baseline|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701144|NCT01848054|B1|Baseline|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701145|NCT01848054|P2|Participant Flow|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701146|NCT01848054|P1|Participant Flow|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701147|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)
701148|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701149|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701150|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701151|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701154|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Day 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701155|NCT01848054|O2|Outcome|Buprenorphine Induction|"Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with OX219 buprenorphine/naloxone sublingual tablets (open-label)~OX219 buprenorphine/naloxone: OX219 buprenorphine/naloxone sublingual tablets~Buprenorphine: Buprenorphine sublingual tablets"
701156|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701157|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701158|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701159|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701160|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701161|NCT01848054|O2|Outcome|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701162|NCT01848054|O1|Outcome|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701163|NCT01848054|E2|Reported Event|Buprenorphine Induction|Days 1-2: Induction on buprenorphine sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701164|NCT01848054|E1|Reported Event|BNX Sublingual Tablets Induction|Days 1-2: Induction on BNX sublingual tablets (blinded); Days 3-28: Maintenance treatment with BNX sublingual tablets (open-label)
701165|NCT01847547|B3|Baseline|Total|Total of all reporting groups
701166|NCT01847547|B2|Baseline|Warfarin|Propensity score matched patients starting treatment with warfarin
701167|NCT01847547|B1|Baseline|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701168|NCT01847547|P2|Participant Flow|Warfarin|Propensity score matched patients starting treatment with warfarin
701169|NCT01847547|P1|Participant Flow|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701170|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701171|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701172|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701173|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701183|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701184|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701185|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701186|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701187|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701188|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701189|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701190|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701191|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701192|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701193|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701194|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701195|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701196|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701197|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701198|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701199|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701200|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701201|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701202|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with Warfarin
701203|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701204|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
701205|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701206|NCT01847547|O2|Outcome|Warfarin|Propensity score matched patients starting treatment with warfarin
701207|NCT01847547|O1|Outcome|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701208|NCT01847547|E2|Reported Event|Warfarin|Propensity score matched patients starting treatment with warfarin
701209|NCT01847547|E1|Reported Event|Dabigatran|Propensity score matched patients starting treatment with dabigatran
701210|NCT01847443|B1|Baseline|Total Participants|
701211|NCT01847443|P4|Participant Flow|4mg Mint Gum/2mg Mint Gum/2mg Ref Gum/4mg Ref Gum|Participants randomly received 4mg nicotine mint gum or 2mg nicotine mint gum or 2mg ref nicotine gum or 4mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
701212|NCT01847443|P3|Participant Flow|2mg Ref Gum/4mg Mint Gum/4mg Ref Gum/2mg Mint Gum|Participants randomly received 2mg ref nicotine gum or 4mg nicotine mint gum or 4mg ref nicotine gum or 2mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
701213|NCT01847443|P2|Participant Flow|4mg Ref Gum/2mg Ref Gum/2mg Mint Gum/4mg Mint Gum|Participants randomly received 4mg ref nicotine gum or 2mg ref nicotine gum or 2mg nicotine mint gum or 4mg nicotine mint gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
701214|NCT01847443|P1|Participant Flow|2mg Mint Gum/4mg Ref Gum/4mg Mint Gum/2mg Ref Gum|Participants randomly received 2mg nicotine mint gum or 4mg reference (ref) nicotine gum or 4mg nicotine mint gum or 2mg ref nicotine gum once daily on Day 1 of treatment period 1. After a 2-7 day washout period, participants were returned to the next treatment period until all four treatment periods were completed.
701215|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
701216|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
701217|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
701218|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
701219|NCT01847443|O2|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
701220|NCT01847443|O1|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
701221|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
701222|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
701223|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
701224|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
701225|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
701226|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
701227|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
701228|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
701229|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
701230|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
701231|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
701232|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
701233|NCT01847443|O4|Outcome|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
701234|NCT01847443|O3|Outcome|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
701235|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
701236|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
701237|NCT01847443|O2|Outcome|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
701238|NCT01847443|O1|Outcome|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
701239|NCT01847443|E4|Reported Event|Reference Nicotine Gum (4 mg)|A single dose of Reference Nicotine Gum (4 mg) to be chewed.
701240|NCT01847443|E3|Reported Event|Test Nicotine Gum (4 mg)|A single dose of Nicotine Mint Gum (4 mg) to be chewed.
701241|NCT01847443|E2|Reported Event|Reference Nicotine Gum (2 mg)|A single dose of Reference Nicotine Gum (2 mg) to be chewed.
701242|NCT01847443|E1|Reported Event|Test Nicotine Gum (2 mg)|A single dose of Nicotine Mint Gum (2 mg) to be chewed.
701243|NCT01847430|B1|Baseline|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701244|NCT01847430|P1|Participant Flow|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701245|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701246|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701247|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701248|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701278|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
701249|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701250|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701251|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701252|NCT01847430|O1|Outcome|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701253|NCT01847430|E1|Reported Event|HBV Group|Subjects received a single dose of Engerix™-B Kinder vaccine (HBV). The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
701254|NCT01847196|B1|Baseline|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
701255|NCT01847196|P1|Participant Flow|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
701256|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
701257|NCT01847196|O1|Outcome|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
701258|NCT01847196|E1|Reported Event|Angel® Catheter|"All eligible subjects received an Angel® Catheter.~The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge."
701259|NCT01847131|B3|Baseline|Total|Total of all reporting groups
701260|NCT01847131|B2|Baseline|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
701261|NCT01847131|B1|Baseline|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
701262|NCT01847131|P2|Participant Flow|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
702354|NCT01840605|B1|Baseline|TAU-284|TAU-284 10mg twice daily for 2 weeks
701263|NCT01847131|P1|Participant Flow|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
701264|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
701265|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
701266|NCT01847131|O2|Outcome|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
701267|NCT01847131|O1|Outcome|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
701268|NCT01847131|E2|Reported Event|Placebo|"placebo nasal spray 2 sprays in each nostril twice daily~Placebo nasal spray: Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient."
701269|NCT01847131|E1|Reported Event|Oxymetazoline|"0.05% oxymetazoline nasal sprays 2 sprays in each nostril twice daily~oxymetazoline: 0.05% Oxymetazoline nasal sprays were commercially available."
701270|NCT01846741|B1|Baseline|VNS Therapy (ITT Population)|Subjects who were implanted with the AspireSR® VNS Therapy® System.
701271|NCT01846741|P1|Participant Flow|VNS Therapy - ITT Population|"Subjects who were implanted with the AspireSR® VNS Therapy® System.~The intent-to-treat (ITT) population is defined as all subjects with the VNS Therapy system implanted and the device had been turned on."
701272|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
701273|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
701274|NCT01846741|O2|Outcome|6-Month|Since Last Visit Assessment
701275|NCT01846741|O1|Outcome|3-Month|Since Last Visit Assessment
701276|NCT01846741|O4|Outcome|18-Month|Since Last Visit Assessment
701277|NCT01846741|O3|Outcome|12-Month|Since Last Visit Assessment
701298|NCT01846741|O1|Outcome|AED Load|Percent Change From Baseline by Visit
701299|NCT01846741|O2|Outcome|Overall Seizure Responder Rate|Overall Seizure (All Seizure Types)
701300|NCT01846741|O1|Outcome|Partial Onset Seizure Responder Rate|Partial Onset Seizures (SPS, CPS, CPS with Secondary GTC)
701301|NCT01846741|O4|Outcome|QOLIE-31-P Scores at 18-Months|Change From Baseline at Each Category
701302|NCT01846741|O3|Outcome|QOLIE-31-P Scores at 12-Months|Change From Baseline at Each Category
701303|NCT01846741|O2|Outcome|QOLIE-31-P Scores at 6-Months|Change From Baseline at Each Category
701304|NCT01846741|O1|Outcome|QOLIE-31-P Scores at 3-Months|Change From Baseline at Each Category
701305|NCT01846741|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
701306|NCT01846741|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
701307|NCT01846741|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
701308|NCT01846741|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
701309|NCT01846741|O3|Outcome|Simple Partial Seizure (SPS)|NHS3 Scores at Follow-Up Visits
701310|NCT01846741|O2|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-up Visits
701311|NCT01846741|O1|Outcome|Complex Partial Seizure (CPS)|NHS3 Scores at Follow-Up Visits
701312|NCT01846741|O6|Outcome|Unknown Seizures|During AutoStim Course in The EMU
701313|NCT01846741|O5|Outcome|Sub-Clinical Seizures|During AutoStim Course in The EMU
701314|NCT01846741|O4|Outcome|Simple Partial Seizures|During AutoStim Course in The EMU
701315|NCT01846741|O3|Outcome|Secondary Generalized Seizures|During AutoStim Course in The EMU
701316|NCT01846741|O2|Outcome|Complex Partial Seizures|During AutoStim Course in The EMU
701317|NCT01846741|O1|Outcome|Overall Seizures|During AutoStim Course in The EMU
701318|NCT01846741|O2|Outcome|During EMU Stay Stair-Stepper Exercise|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
701319|NCT01846741|O1|Outcome|During EMU Stay|Non-Seizure Related Stimulation Rate (AutoStim Per Hour)
701320|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
701321|NCT01846741|O1|Outcome|% Sensitivity|Based on Heart rate Increase Associated with Seizures by Threshold for AutoStim
701322|NCT01846741|O3|Outcome|Total|Seizures Reported by Investigators and Triple Reviewers
701323|NCT01846741|O2|Outcome|Reported by Triple Review|EMU Seizures Identified Post EMU
701324|NCT01846741|O1|Outcome|Reported By Investigators|All Seizures Identified (During EMU)
701325|NCT01846741|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the end of study for all subjects treated/implanted with the AspireSR® VNS Therapy® system. Only the most common AEs (> 5%) are reported in the AE data table.
701326|NCT01846455|B6|Baseline|Total|Total of all reporting groups
701327|NCT01846455|B5|Baseline|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701328|NCT01846455|B4|Baseline|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701329|NCT01846455|B3|Baseline|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701330|NCT01846455|B2|Baseline|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701331|NCT01846455|B1|Baseline|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701332|NCT01846455|P5|Participant Flow|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701333|NCT01846455|P4|Participant Flow|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701334|NCT01846455|P3|Participant Flow|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701335|NCT01846455|P2|Participant Flow|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701336|NCT01846455|P1|Participant Flow|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701337|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701338|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701339|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701433|NCT01846442|E4|Reported Event|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701340|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701341|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701342|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701343|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701344|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701345|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701346|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701347|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701348|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701349|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701350|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701351|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701352|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701353|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701354|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701415|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701355|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701356|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701357|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701358|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701359|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701360|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701361|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701362|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701363|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701364|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701365|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701366|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701367|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701368|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701369|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701370|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701371|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701372|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701373|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701374|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701375|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701376|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701377|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701378|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701379|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701380|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701381|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701382|NCT01846455|O5|Outcome|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701383|NCT01846455|O4|Outcome|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701384|NCT01846455|O3|Outcome|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701385|NCT01846455|O2|Outcome|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701386|NCT01846455|O1|Outcome|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701387|NCT01846455|E5|Reported Event|No Hepatic Disease or Impairment|Participants with no hepatic disease or impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701388|NCT01846455|E4|Reported Event|HCV Without Hepatic Impairment|Participants with hepatitis C virus (HCV) without hepatic impairment received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701389|NCT01846455|E3|Reported Event|Hepatic Impairment: Child-Pugh C|Participants with chronic liver disease and classified as Child-Pugh Grade C had a score of 10-15 (out of 15) which correlates with decompensated liver disease. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701390|NCT01846455|E2|Reported Event|Hepatic Impairment: Child-Pugh B|Participants with chronic liver disease and classified as Child-Pugh Grade B had a score of 7-9 (out of 15) which correlates with significant functional liver compromise. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701391|NCT01846455|E1|Reported Event|Hepatic Impairment: Child-Pugh A|Participants with chronic liver disease and classified as Child-Pugh Grade A had a score of 5-6 (out of 15) which correlates with a good prognosis. Each participant received one sublingual tablet of Suboxone® (2mg buprenorphine with 0.5 mg naloxone) on Day 1.
701392|NCT01846442|B5|Baseline|Total|Total of all reporting groups
701393|NCT01846442|B4|Baseline|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701394|NCT01846442|B3|Baseline|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701395|NCT01846442|B2|Baseline|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701396|NCT01846442|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701397|NCT01846442|P4|Participant Flow|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701398|NCT01846442|P3|Participant Flow|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701399|NCT01846442|P2|Participant Flow|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701400|NCT01846442|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701401|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701402|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701403|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701404|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701405|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701406|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701407|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701408|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701409|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701410|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701411|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701412|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701413|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701414|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701416|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701417|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701418|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701419|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701420|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701421|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701422|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701423|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701424|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701425|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701426|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701427|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701428|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701429|NCT01846442|O4|Outcome|1.00% DHEA|DHEA (1.00%): Vaginal suppository containing 1.00% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
701430|NCT01846442|O3|Outcome|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701431|NCT01846442|O2|Outcome|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701432|NCT01846442|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701434|NCT01846442|E3|Reported Event|0.50% DHEA|DHEA (0.50%): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
701435|NCT01846442|E2|Reported Event|0.25% DHEA|DHEA (0.25%): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
701436|NCT01846442|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
701437|NCT01846416|B4|Baseline|Total|Total of all reporting groups
701438|NCT01846416|B3|Baseline|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701439|NCT01846416|B2|Baseline|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701440|NCT01846416|B1|Baseline|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701441|NCT01846416|P3|Participant Flow|Atezolizumab (MPDL3280): 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701442|NCT01846416|P2|Participant Flow|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701443|NCT01846416|P1|Participant Flow|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced non-small cell lung cancer (NSCLC) disease received atezolizumab intravenously (IV) as a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until disease progression.
701444|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
701445|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : All Arms|All participants included in the study were reported.
701446|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701447|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701448|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701490|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
701656|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701449|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701450|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701451|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701452|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701453|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701454|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701455|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701456|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701457|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701458|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701459|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701460|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701461|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701462|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280): 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701463|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701464|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701465|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701466|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701467|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701520|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701521|NCT01846299|E3|Reported Event|Sham Without Ranibizumab 0.5mg|Sham without Ranibizumab 0.5mg
701468|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701469|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701470|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701471|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701472|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701473|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701474|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701475|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701476|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701477|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701478|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701479|NCT01846416|O3|Outcome|Atezolizumab (MPDL3280) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701480|NCT01846416|O2|Outcome|Atezolizumab (MPDL3280) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701481|NCT01846416|O1|Outcome|Atezolizumab (MPDL3280) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701482|NCT01846416|E3|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Brain Metastases Participants|Participants with previously treated brain metastases and who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to the maximum number of prior therapies, received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701483|NCT01846416|E2|Reported Event|Atezolizumab (MPDL3280A) : 2L+ Participants|Participants who had progressed during or following a prior platinum-based chemotherapy regimen without restriction to maximum number of prior therapies received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until no longer deemed to be experiencing clinical benefit as assessed by the investigator.
701484|NCT01846416|E1|Reported Event|Atezolizumab (MPDL3280A) : 1L Participants|Participants with no prior chemotherapy for advanced NSCLC disease received atezolizumab IV as a fixed dose of 1200-mg on Day 1 of each 21-day cycle until disease progression.
701485|NCT01846299|B3|Baseline|Total|Total of all reporting groups
701486|NCT01846299|B2|Baseline|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701487|NCT01846299|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701488|NCT01846299|P2|Participant Flow|Sham|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701489|NCT01846299|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701491|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701492|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701493|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
701494|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701495|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701496|NCT01846299|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
701497|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701498|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701499|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701500|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701501|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701502|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701503|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701504|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701505|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701506|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701507|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701508|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701509|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701510|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701511|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701512|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701513|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701514|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701515|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701516|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701517|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701518|NCT01846299|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
701519|NCT01846299|O2|Outcome|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
701524|NCT01846104|B1|Baseline|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
701525|NCT01846104|P1|Participant Flow|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial (NCT01317667). Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
701526|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
701527|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
701528|NCT01846104|O1|Outcome|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
701529|NCT01846104|E1|Reported Event|50-μg Booster Dose RVEc|"Subjects will be receive one 50-μg dose of RVEc~50-μg booster dose RVEc: Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination."
701530|NCT01846039|B1|Baseline|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701531|NCT01846039|P1|Participant Flow|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701532|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
702090|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
701533|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701534|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701535|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701536|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701537|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701538|NCT01846039|O1|Outcome|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701539|NCT01846039|E1|Reported Event|JUVÉDERM VOLUMA®|Participants treated with JUVÉDERM VOLUMA® up to 3 mLs administered by intradermal injection.
701540|NCT01845831|B3|Baseline|Total|Total of all reporting groups
701541|NCT01845831|B2|Baseline|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
701542|NCT01845831|B1|Baseline|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701543|NCT01845831|P5|Participant Flow|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:~Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
701544|NCT01845831|P4|Participant Flow|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:~Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
701545|NCT01845831|P3|Participant Flow|Metformin and Sitagliptin|"Outpatient Phase:~Patients with HbA1c ≤ 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months~Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
701546|NCT01845831|P2|Participant Flow|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
701547|NCT01845831|P1|Participant Flow|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701548|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701549|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701657|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701550|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701551|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701552|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701553|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701554|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701555|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701556|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701557|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701558|NCT01845831|O3|Outcome|Metformin and Sitagliptin + Glargine 80%|"Outpatient Phase:~Patients with HbA1c > 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 80%: Patients with HbA1c > 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (80% of the inpatient glargine dose) for 6 months"
701559|NCT01845831|O2|Outcome|Metformin and Sitagliptin + Glargine 50%|"Outpatient Phase:~Patients with HbA1c between 7% and 9% during the inpatient phase were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months~Metformin and sitagliptin + glargine 50%: Patients with HbA1c between 7% and 9% were discharged on metformin and sitagliptin (Janumet ® 500/50 mg) twice daily plus glargine insulin (50% of the inpatient glargine dose) for 6 months"
701560|NCT01845831|O1|Outcome|Metformin and Sitagliptin|"Outpatient Phase:~Patients with HbA1c < 7% during the inpatient phase were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months~Metformin and sitagliptin: Patients with HbA1c ≤ 7% were discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months"
701561|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701562|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701563|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701564|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701565|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701566|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701567|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701568|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701569|NCT01845831|O2|Outcome|Basal Bolus (Hospital)|"Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed"
701570|NCT01845831|O1|Outcome|Sitagliptin + Glargine (Hospital)|"Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701571|NCT01845831|E2|Reported Event|Basal Bolus (Hospital)|"Inpatient Phase:~Glargine once daily and rapid-acting insulin before meals + correction doses of aspart or lispro if needed~Basal Bolus: Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + correction doses of rapid acting insulin if needed"
701572|NCT01845831|E1|Reported Event|Sitagliptin + Glargine (Hospital)|"Inpatient Phase:~Sitagliptin and glargine once daily + correction doses of aspart or lispro if needed~Sitagliptin + glargine: Sitagliptin and Glargine once daily + correction doses of rapid acting insulin if needed"
701573|NCT01845155|B3|Baseline|Total|Total of all reporting groups
701574|NCT01845155|B2|Baseline|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
701575|NCT01845155|B1|Baseline|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
701576|NCT01845155|P2|Participant Flow|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
701577|NCT01845155|P1|Participant Flow|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
701578|NCT01845155|O2|Outcome|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
701600|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701601|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701579|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
701580|NCT01845155|O2|Outcome|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
701581|NCT01845155|O1|Outcome|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
701582|NCT01845155|E2|Reported Event|Counselling|"Counselling~Counselling : Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group."
701583|NCT01845155|E1|Reported Event|Music Therapy|"Neuro-Music-Therapy according to the Heidelberg Model~Neuro-Music-Therapy according to the Heidelberg Model : The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.~For more details on the music therapy see Argstatter et al. 2012"
701584|NCT01845103|B1|Baseline|PEARL 8.0|
701585|NCT01845103|P1|Participant Flow|PEARL 8.0|Received TMR with PEARL 8.0
701586|NCT01845103|O1|Outcome|PEARL 8.0|
701587|NCT01845103|O1|Outcome|PEARL 8.0|
701588|NCT01845103|E1|Reported Event|PEARL 8.0|
701589|NCT01845077|B4|Baseline|Total|Total of all reporting groups
701590|NCT01845077|B3|Baseline|Total 1500 Fasted|Patients were administered 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701591|NCT01845077|B2|Baseline|Total 1000 Fed|Patients were administered 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR orally in the morning under fed conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fed conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701592|NCT01845077|B1|Baseline|Total 1000 Fasted|Patients were administered 1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) orally in the morning under fasted conditions in one treatment period and 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR orally in the morning under fasted conditions in the other treatment period. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701760|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
701593|NCT01845077|P6|Participant Flow|L+M1500 Fasted, Then FDC1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701594|NCT01845077|P5|Participant Flow|FDC1500 Fasted, Then L+M1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701595|NCT01845077|P4|Participant Flow|L+M1000 Fed, Then FDC1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701596|NCT01845077|P3|Participant Flow|FDC1000 Fed, Then L+M1000 Fed|1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the first treatment period orally in the morning under fed conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fed conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701597|NCT01845077|P2|Participant Flow|L+M1000 Fasted, Then FDC1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 FDC tablet 5 mg linagliptin/1000 mg metformin XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701598|NCT01845077|P1|Participant Flow|FDC1000 Fasted, Then L+M1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered on Day 1 of the first treatment period orally in the morning under fasted conditions, then 1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered on Day 1 of the second treatment period orally in the morning under fasted conditions. Both periods lasted 4 days, separated by a washout period of at least 35 days.
701599|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
702091|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
701602|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701603|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701604|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701605|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
701606|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701607|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701608|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701609|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701610|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701611|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
701612|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701613|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701614|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701615|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701616|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701617|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
701618|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701619|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701658|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701620|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701621|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701622|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701623|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701624|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701625|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701626|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701627|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701628|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701629|NCT01845077|O6|Outcome|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
701630|NCT01845077|O5|Outcome|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701631|NCT01845077|O4|Outcome|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701632|NCT01845077|O3|Outcome|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701633|NCT01845077|O2|Outcome|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701634|NCT01845077|O1|Outcome|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701635|NCT01845077|E6|Reported Event|L+M1500 Fasted|1 tablet linagliptin 5 mg and 3 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions
701636|NCT01845077|E5|Reported Event|FDC1500 Fasted|2 FDC tablets 2.5 mg linagliptin/750 mg metformin XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701637|NCT01845077|E4|Reported Event|L+M1000 Fed|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701638|NCT01845077|E3|Reported Event|FDC1000 Fed|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fed conditions.
701639|NCT01845077|E2|Reported Event|L+M1000 Fasted|1 tablet linagliptin 5 mg and 2 tablets metformin 500 mg XR administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701640|NCT01845077|E1|Reported Event|FDC1000 Fasted|1 fixed dose combination (FDC) tablet 5 mg linagliptin/1000 mg metformin extended release (XR) administered orally in the morning of Day 1 of the corresponding treatment period under fasted conditions.
701641|NCT01845025|B3|Baseline|Total|Total of all reporting groups
701642|NCT01845025|B2|Baseline|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701643|NCT01845025|B1|Baseline|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701644|NCT01845025|P2|Participant Flow|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701645|NCT01845025|P1|Participant Flow|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701646|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701647|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701648|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701649|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701650|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701651|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701652|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701653|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701654|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701655|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701659|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701660|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701661|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701662|NCT01845025|O2|Outcome|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701663|NCT01845025|O1|Outcome|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701664|NCT01845025|E2|Reported Event|Fluticasone Propionate (FP)|fluticasone propionate 100 mcg, 250 mcg or 500 mcg + Placebo to Match Formoterol 12 mcg for inhalation
701665|NCT01845025|E1|Reported Event|FOM 12 mcg + FP|Formoterol 12 mcg + fluticasone propionate 100 mcg, 250 mcg or 500 mcg for inhalation
701666|NCT01844895|B1|Baseline|125 mg Abatacept (Autoinjector and Prefilled Syringe)|Participants self administered 125 mg SC abatacept weekly via prefilled syringe from Day 1 up to Day 29. Starting on Day 29, 125 mg SC abatacept was self administered weekly via autoinjector for 3 months.
701667|NCT01844895|P1|Participant Flow|125 mg Abatacept (Autoinjector and Prefilled Syringe)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months. Participants could discontinue from the autoinjector substudy and switch back to prefilled syringes at any time during the study. Following the 4 months of the substudy, participants could continue to receive abatacept SC via the autoinjector or switch back to the prefilled syringe until the close of the IM101-174 parent study.
701668|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector- Day 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
701669|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
701670|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days throughout the substudy.
701671|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
701672|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
701673|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
701674|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
701675|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe-Days 22, 24, 25, 26, 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
701676|NCT01844895|O2|Outcome|125 mg Abatacept SC Autoinjector-Days 106, 108, 109, 110, 113|125 mg Abatacept SC was self-administered with a autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
701677|NCT01844895|O1|Outcome|125 mg Abatacept SC Prefilled Syringe - Days 22, 24, 25, 26,29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
701678|NCT01844895|O2|Outcome|125 mg Abatacept SC Using Autoinjector - Day 113|125 mg Abatacept SC was self-administered with an autoinjector starting on Day 29. Participants continued to self-administer abatacept with the autoinjector every 7 days for 3 months.
701679|NCT01844895|O1|Outcome|125 mg Abatacept SC Using Prefilled Syringe - Day 29|125 mg Abatacept SC was self-administered with a BD Hypak™ Physiolis prefilled syringe every 7 days for the first 4 weeks of the substudy until Day 29.
701680|NCT01844895|E2|Reported Event|Abatacept Cumulative (Prefilled Syringe and Autoinjector)|125 mg SC abatacept was self administered weekly via pre-filled syringes from Day 1 up to Day 29 when the participant was switched to self administering 125 mg SC abatacept via the autoinjector device for 3 months.
701681|NCT01844895|E1|Reported Event|Abatacept Via Autoinjector Only (Day 29 to End of Study)|Participants received 125 mg SC abatacept via the autoinjector starting Day 29 and through the remaining 3 months of the substudy.
701682|NCT01844856|B3|Baseline|Total|Total of all reporting groups
701683|NCT01844856|B2|Baseline|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
701684|NCT01844856|B1|Baseline|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
701685|NCT01844856|P2|Participant Flow|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 grams (g) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days.
701686|NCT01844856|P1|Participant Flow|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered intravenously (IV) at a dose of 1.0 milligrams per kilogram of body weight (mg/kg) every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days.
701687|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
701688|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
701689|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
701690|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
701691|NCT01844856|O2|Outcome|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
701692|NCT01844856|O1|Outcome|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
701693|NCT01844856|E2|Reported Event|Ertapenem, 1.0 g q24h|Ertapenem was administered IV at a dose of 1.0 g q24h for a minimum of 4 days and a maximum of 14 days.
701694|NCT01844856|E1|Reported Event|Eravacycline, 1.0 mg/kg q12h|Eravacycline was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days.
701695|NCT01844817|B3|Baseline|Total|Total of all reporting groups
701696|NCT01844817|B2|Baseline|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701697|NCT01844817|B1|Baseline|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701698|NCT01844817|P2|Participant Flow|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701699|NCT01844817|P1|Participant Flow|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701780|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
701700|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701701|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701702|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701703|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701704|NCT01844817|O2|Outcome|Placebo|"Placebo (Dextrose 5% in Water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701705|NCT01844817|O1|Outcome|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701706|NCT01844817|E2|Reported Event|Placebo|"Placebo (dextrose 5% in water): Three separate loading doses administered over 1 week prior to Cycle 1 of chemotherapy, followed by weekly doses on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701707|NCT01844817|E1|Reported Event|OGX-427|"OGX-427: Three separate loading doses at 600mg IV over 1 week prior to Cycle 1 of chemotherapy, followed by 600mg IV once weekly on Days 1, 8, 15, and 22 of each 28 day cycle concurrent with chemotherapy.~Chemotherapy: nab-paclitaxel (125mg/m^2 IV) and gemcitabine (1000mg/m^2 IV) on Days 1, 8, and 15 of each cycle. Patients continued 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment."
701708|NCT01844778|B4|Baseline|Total|Total of all reporting groups
701709|NCT01844778|B3|Baseline|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701710|NCT01844778|B2|Baseline|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701759|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
701711|NCT01844778|B1|Baseline|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701712|NCT01844778|P3|Participant Flow|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701713|NCT01844778|P2|Participant Flow|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701714|NCT01844778|P1|Participant Flow|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701715|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701716|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701717|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701718|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701781|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
701782|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
701719|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701720|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701721|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701722|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701723|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701724|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701725|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701726|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701727|NCT01844778|O3|Outcome|TIP/TIP|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701728|NCT01844778|O2|Outcome|COLI/TIP|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701729|NCT01844778|O1|Outcome|TIS/TIP|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701730|NCT01844778|E7|Reported Event|Overall TIP Cycle 2|During the second cycle, each treatment group received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701731|NCT01844778|E6|Reported Event|TIP/TIP - Cycle 2|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701732|NCT01844778|E5|Reported Event|TIP/TIP - Cycle 1|During the first and second cycles, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
703006|NCT01836458|E4|Reported Event|Dose 4: 15mg|Single dose of KAE609 15 mg
701733|NCT01844778|E4|Reported Event|COLI/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701734|NCT01844778|E3|Reported Event|COLI/TIP - Cycle 1|During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines.
701735|NCT01844778|E2|Reported Event|TIS/TIP - Cycle 2|During the second cycle, participants received TIP 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
701736|NCT01844778|E1|Reported Event|TIS/TIP - Cycle 1|During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment.
701737|NCT01844700|B3|Baseline|Total|Total of all reporting groups
701738|NCT01844700|B2|Baseline|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 patients were randomized to usual care"
701739|NCT01844700|B1|Baseline|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 patients were randomized to Ziprasidone"
701740|NCT01844700|P2|Participant Flow|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants"
701741|NCT01844700|P1|Participant Flow|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants"
701742|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
701743|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
701744|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
701745|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
701746|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
701747|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
701748|NCT01844700|O2|Outcome|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes"
701749|NCT01844700|O1|Outcome|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes"
701750|NCT01844700|E2|Reported Event|Aripiprazole, Quetiapine, Risperidone|"Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks~aripiprazole, quetiapine, or risperidone: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)~3 participants, only two completed study, no sufficient data for weight changes~there were no serious adverse events in this group"
701751|NCT01844700|E1|Reported Event|Ziprasidone|"(20-160mg/d, bid) for 12 weeks~Ziprasidone: random assignment to ZIP (20-160mg/d, bid dosing)~4 participants, only one completed study and he was questionable compliant, no sufficient data for weight changes~there were no serious adverse events in this group"
701752|NCT01844687|B1|Baseline|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol~A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
701753|NCT01844687|P1|Participant Flow|Single Group|"Each subject in the study will be tested on eight days, each day receiving a different combination of active/inactive marijuana cigarette plus 0, 200, 400 or 800 mg of cannabidiol~A subset of study completers will be given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion"
701754|NCT01844687|O1|Outcome|Plasma CBD Concentrations|Eight of the 31 participants who completed the study came to a ninth session to receive 800 mg CBD and donate seven blood samples over six hours, one immediately before swallowing CBD capsules, and 6 throughout the next six hours. Plasma samples were analyzed through NIDA contract #NO1DA-14-7788 to David Moody, Ph.D.
701755|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
701756|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
701757|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
701758|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
701761|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
701762|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
701763|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
701764|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
701765|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
701766|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
701767|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
701768|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
701769|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
701770|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
701771|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
701772|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
701773|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
701774|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
701775|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
701776|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
701777|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
701778|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|MJ cigarette with 5.3% THC content pretreated with 0 mg CBD
701779|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
702092|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
701783|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
701784|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
701785|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
701786|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on the strength of effects of smoking 5.30% THC cannabis cigarettes
701787|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
701788|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
701789|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
701790|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
701791|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
701792|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
701793|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
701794|NCT01844687|O1|Outcome|Active MJ With 0 mg CBD|a placebo comparator measuring the effect of CBD on liking the effects of smoking 5.30% THC cannabis cigarettes
701795|NCT01844687|O8|Outcome|Inactive MJ With 800 mg CBD|MJ cigarette with 0.01% THC content pretreated with 800 mg CBD
701796|NCT01844687|O7|Outcome|Inactive MJ With 400 mg CBD|MJ cigarette with 0.01% THC content pretreated with 400 mg CBD
701797|NCT01844687|O6|Outcome|Inactive MJ With 200 mg CBD|MJ cigarette with 0.01% THC content pretreated with 200 mg CBD
701798|NCT01844687|O5|Outcome|Inactive MJ With 0 mg CBD|MJ cigarette with 0.01% THC content pretreated with 0 mg CBD
701799|NCT01844687|O4|Outcome|Active MJ With 800 mg CBD|MJ cigarette with 5.3% THC content pretreated with 800 mg CBD
701800|NCT01844687|O3|Outcome|Active MJ With 400 mg CBD|MJ cigarette with 5.3% THC content pretreated with 400 mg CBD
701801|NCT01844687|O2|Outcome|Active MJ With 200 mg CBD|MJ cigarette with 5.3% THC content pretreated with 200 mg CBD
701802|NCT01844687|O1|Outcome|Active Marijuana (MJ) With 0 mg Cannabidiol (CBD)|a placebo comparator measuring the effect of cannabidiol (CBD) on moods produced by smoking 5.30% tetrahydrocannabinol (THC) cannabis cigarettes
701803|NCT01844687|E8|Reported Event|Inactive MJ With 800 mg CBD|"31 subjects were tested with 800 mg CBD and Inactive MJ cigarette.~8 of the 31 study completers were given 800 mg of cannabidiol on one additional study visit to measure plasma concentrations of cannabidiol for up to 360 minutes after ingestion. No MJ cigarette was smoked during this session. Adverse events reported during this session are included here."
701804|NCT01844687|E7|Reported Event|Inactive MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an inactive marijuana cigarette.
701805|NCT01844687|E6|Reported Event|Inactive MJ With 200 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
701806|NCT01844687|E5|Reported Event|Inactive MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an inactive MJ cigarette.
701807|NCT01844687|E4|Reported Event|Active MJ With 800 mg CBD|31 subjects were tested with 800 mg CBD and an active MJ cigarette.
701808|NCT01844687|E3|Reported Event|Active MJ With 400 mg CBD|31 subjects were tested with 400 mg CBD and an active marijuana cigarette.
701809|NCT01844687|E2|Reported Event|Active MJ With 200 mg CBD|31 subjects were tested with 200 mg CBD and an active marijuana cigarette.
701810|NCT01844687|E1|Reported Event|Active MJ With 0 mg CBD|31 subjects were tested with 0 mg CBD and an active marijuana cigarette.
701811|NCT01844531|B5|Baseline|Total|Total of all reporting groups
701835|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701836|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701812|NCT01844531|B4|Baseline|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
701813|NCT01844531|B3|Baseline|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
701814|NCT01844531|B2|Baseline|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|"Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC).~Oral administration."
701815|NCT01844531|B1|Baseline|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|"Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets).~Oral administration."
701816|NCT01844531|P4|Participant Flow|Empa5+Met500/ FDC Empa5/ Empa12.5+Met500/ FDC Empa12.5|Participants first received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). Oral administration.
701982|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
702093|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
701817|NCT01844531|P3|Participant Flow|FDC Empa5/ Empa5+Met500/ FDC Empa12.5/ Empa12.5+Met500|Participants first received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets)Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
701818|NCT01844531|P2|Participant Flow|Empa12.5+Met500/ FDC Empa12.5/ Empa5+Met500/ FDC Empa5|Participants first received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T1 (12.5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). Oral administration.
701819|NCT01844531|P1|Participant Flow|FDC Empa12.5/ Empa12.5+Met500/ FDC Empa5/ Empa5+Met500|Participants first received Treatment T1 (12.5 mg empagliflozin/500 mg metformin Fixed Dose Combination (FDC)). After a washout phase of at least 5 days, they then received Treatment R1 (12.5 mg empagliflozin and 500 mg metformin, single tablets). After a washout phase of at least 5 days, they then received Treatment T2 (5 mg empagliflozin/500 mg metformin FDC). After a washout phase of at least 5 days, they then received Treatment R2 (5 mg empagliflozin and 500 mg metformin, single tablets). Oral administration.
701820|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701821|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701822|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701823|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701824|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701825|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701826|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701827|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701828|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701829|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701830|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701831|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701832|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701833|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701834|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701837|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701838|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701839|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701840|NCT01844531|O4|Outcome|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701841|NCT01844531|O3|Outcome|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701842|NCT01844531|O2|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701843|NCT01844531|O1|Outcome|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701844|NCT01844531|E4|Reported Event|5 mg Empagliflozin and 500 mg Metformin as Single Tablets|5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701845|NCT01844531|E3|Reported Event|5 mg Empagliflozin and 500 mg Metformin as FDC|5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701846|NCT01844531|E2|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as Single Tablets|12.5 mg empagliflozin and 500 mg metformin as single tablets, oral administration
701847|NCT01844531|E1|Reported Event|12.5 mg Empagliflozin and 500 mg Metformin as FDC|12.5 mg empagliflozin/500 mg metformin as Fixed Dose Combination, oral administration
701848|NCT01844518|B1|Baseline|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
701849|NCT01844518|P1|Participant Flow|SC Abatacept Ages 6 to 17|Subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to the following weight-tiered dosing regimen: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
702094|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
701850|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
701851|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
701852|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
701853|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
701854|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
701855|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
701856|NCT01844518|O3|Outcome|>=50 kg Dosing Group|Weight-tiered dosing group receiving 125 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
701857|NCT01844518|O2|Outcome|25 to <50 kg Dosing Group|Weight-tiered dosing group receiving 87.5 mg subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
701858|NCT01844518|O1|Outcome|10 to <25 kg Dosing Group|Weight-tiered dosing group receiving 50 milligrams (mg) subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
701859|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered by prefilled syringe (PFS) once weekly according to weight-tiered dose regimen as follows: 10 to < 25kg (50 mg in 0.4 mL PFS), 25 to < 50 kg (87.5 mg in 0.7 mL PFS) and 50 kg (125 mg in 1 mL PFS).
701860|NCT01844518|O1|Outcome|Combined Abatacept Dosing Groups, Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
701861|NCT01844518|E1|Reported Event|SC Abatacept Ages 6 to 17|All weight-tiered dosing groups receiving subcutaneous (SC) abatacept administered to 6 to 17 year old participants by prefilled syringe (PFS) once weekly
701862|NCT01844479|B1|Baseline|All Study Participants|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
701919|NCT01843972|B5|Baseline|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701920|NCT01843972|B4|Baseline|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701863|NCT01844479|P2|Participant Flow|Diabetic Foot Orthotic Followed by Standard Innersole|"The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701864|NCT01844479|P1|Participant Flow|Standard Innersole Followed by DFO|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole~DFO The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load."
701865|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701866|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701983|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701867|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701868|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701869|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701870|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701871|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701872|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701873|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701874|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701921|NCT01843972|B3|Baseline|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701875|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701876|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701877|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701878|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701879|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701880|NCT01844479|O1|Outcome|Standard Innersole|"Per sequence cross over design. Order of testing innersoles was randomized and each testing condition lasted 15 minutes.~The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
702088|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
701881|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701882|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701883|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701884|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701885|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701886|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701887|NCT01844479|O2|Outcome|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701888|NCT01844479|O1|Outcome|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701922|NCT01843972|B2|Baseline|BI 691751dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701923|NCT01843972|B1|Baseline|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
701965|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701889|NCT01844479|E2|Reported Event|Diabetic Foot Orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
701890|NCT01844479|E1|Reported Event|Standard Innersole|"The industry standard diabetic innersole will be used as the active comparator~Standard innersole"
701891|NCT01844388|B3|Baseline|Total|Total of all reporting groups
701892|NCT01844388|B2|Baseline|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701893|NCT01844388|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701894|NCT01844388|P2|Participant Flow|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701895|NCT01844388|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701896|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701897|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701898|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701899|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701900|NCT01844388|O2|Outcome|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701901|NCT01844388|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701902|NCT01844388|E2|Reported Event|REFRESH CONTACTS®|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701903|NCT01844388|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
701904|NCT01844206|B3|Baseline|Total|Total of all reporting groups
701905|NCT01844206|B2|Baseline|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
701906|NCT01844206|B1|Baseline|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
701907|NCT01844206|P2|Participant Flow|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
701908|NCT01844206|P1|Participant Flow|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
701909|NCT01844206|O2|Outcome|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
701910|NCT01844206|O1|Outcome|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
701911|NCT01844206|E2|Reported Event|Epidural Saline|"Group receiving epidural saline 6ml, 24 hours after receiving epidural morphine 3mg.~Epidural Saline: Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg."
701912|NCT01844206|E1|Reported Event|Epidural Morphine|"Group receiving 3mg epidural morphine, 24 hours after the initial dose~Epidural Morphine: Patients will be given 3mg epidural morphine, 24 hours after the initial dose."
701913|NCT01843972|B11|Baseline|Total|Total of all reporting groups
701914|NCT01843972|B10|Baseline|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701915|NCT01843972|B9|Baseline|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
701916|NCT01843972|B8|Baseline|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701917|NCT01843972|B7|Baseline|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701918|NCT01843972|B6|Baseline|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701924|NCT01843972|P10|Participant Flow|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701925|NCT01843972|P9|Participant Flow|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
701926|NCT01843972|P8|Participant Flow|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701927|NCT01843972|P7|Participant Flow|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701928|NCT01843972|P6|Participant Flow|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701929|NCT01843972|P5|Participant Flow|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701930|NCT01843972|P4|Participant Flow|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701931|NCT01843972|P3|Participant Flow|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701932|NCT01843972|P2|Participant Flow|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701933|NCT01843972|P1|Participant Flow|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
701934|NCT01843972|O8|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701935|NCT01843972|O7|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701936|NCT01843972|O6|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701937|NCT01843972|O5|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701938|NCT01843972|O4|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701939|NCT01843972|O3|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701940|NCT01843972|O2|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701941|NCT01843972|O1|Outcome|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
701942|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701943|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701944|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701945|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701946|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701947|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701948|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701949|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701950|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701951|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701952|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701953|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701954|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701955|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701956|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701957|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701958|NCT01843972|O10|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701959|NCT01843972|O9|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
701960|NCT01843972|O8|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
701961|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701962|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701963|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701964|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
702126|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
701966|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701967|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701968|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701969|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701970|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701971|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701972|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701973|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701974|NCT01843972|O2|Outcome|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701975|NCT01843972|O1|Outcome|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701976|NCT01843972|O8|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701977|NCT01843972|O7|Outcome|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701978|NCT01843972|O6|Outcome|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701979|NCT01843972|O5|Outcome|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701980|NCT01843972|O4|Outcome|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701981|NCT01843972|O3|Outcome|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701984|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701985|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|single dose given as 1 tablet; poor metabolizers; BI 691751: 1 tablet (10 mg)
701986|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|single dose given as 1 tablet; extensive metabolizers; BI 691751: 1 tablet (10 mg)
701987|NCT01843972|O3|Outcome|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701988|NCT01843972|O2|Outcome|BI 691751 Tablet Poor Metabolizers (Part II)|"single dose given as 1 tablet; poor metabolizers;~BI 691751: 1 tablet (10 mg)"
701989|NCT01843972|O1|Outcome|BI 691751 Tablet Extensive Metabolizers (Part II)|"single dose given as 1 tablet; extensive metabolizers;~BI 691751: 1 tablet (10 mg)"
701990|NCT01843972|E10|Reported Event|BI 691751 Solution (Part II); Extensive Metabolizers|"single dose given as oral solution BI 691751: oral solution (10 mg)~5 subjects had no measurable concentration of BI 691751 because a drug-free solution has been administered by mistake. Therefore their results were excluded from all analyses."
701991|NCT01843972|E9|Reported Event|BI 691751 Tablet (Part II)|"single dose given as 1 tablet~BI 691751: 1 tablet (10 mg)"
701992|NCT01843972|E8|Reported Event|BI 691751 Dose 7 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 7 (90 mg powder)"
701993|NCT01843972|E7|Reported Event|BI 691751 Dose 6 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 6 (60 mg powder)"
701994|NCT01843972|E6|Reported Event|BI 691751 Dose 5 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 5 (30 mg powder)"
701995|NCT01843972|E5|Reported Event|BI 691751 Dose 4 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 4 (15 mg powder)"
701996|NCT01843972|E4|Reported Event|BI 691751 Dose 3 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 3 (5 mg powder)"
701997|NCT01843972|E3|Reported Event|BI 691751 Dose 2 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 691751, dose 2 (1.5 mg powder)"
701998|NCT01843972|E2|Reported Event|BI 691751 Dose 1 (Part I)|"single dose given as oral solution~BI 691751: oral solution BI 69175, dose 1 (0.5 mg powder)"
701999|NCT01843972|E1|Reported Event|Placebo (Part I)|"placebo solution~Placebo: placebo solution"
702000|NCT01843933|B3|Baseline|Total|Total of all reporting groups
702001|NCT01843933|B2|Baseline|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
702002|NCT01843933|B1|Baseline|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
702003|NCT01843933|P2|Participant Flow|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
702127|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702004|NCT01843933|P1|Participant Flow|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
702005|NCT01843933|O2|Outcome|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
702006|NCT01843933|O1|Outcome|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
702007|NCT01843933|E2|Reported Event|Intervention: Standard Monitoring and Capnography Viewable|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, and the screen will be viewable by staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data.
702008|NCT01843933|E1|Reported Event|Control: Standard Monitoring and Blinded to Capnography|Standard monitoring will be applied to all patients. Capnography monitoring will be applied to all patients, but the screen out of site of staff. Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion will be used to collect and record data but staff will be blinded to the monitor output.
702009|NCT01843920|B3|Baseline|Total|Total of all reporting groups
702010|NCT01843920|B2|Baseline|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702011|NCT01843920|B1|Baseline|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702012|NCT01843920|P2|Participant Flow|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702013|NCT01843920|P1|Participant Flow|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702014|NCT01843920|O2|Outcome|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702015|NCT01843920|O1|Outcome|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702016|NCT01843920|E2|Reported Event|Post Surgery With Glaucoma Drops|"This will be for the group that had gas duration surgery (using SF6 or C3F8). In addition to the standard post-operative topical drops, glaucoma drops, Timolol-dorzolamide (timolol 0.5%-dorzolamide 2%) will be given.~Timolol-dorzolamide (Glaucoma drops): Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702017|NCT01843920|E1|Reported Event|Post Surgery Without Glaucoma Drops|"This will be for the group that had gas duration surgery using SF6 (Sulfur Hexafluoride) or C3F8 (perfluoropropane gas tamponade) and only uses the standard post-operative topical drops.~standard post-operative topical drops: Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim"
702018|NCT01843777|B3|Baseline|Total|Total of all reporting groups
702019|NCT01843777|B2|Baseline|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
702020|NCT01843777|B1|Baseline|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
702128|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702129|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
702021|NCT01843777|P2|Participant Flow|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
702022|NCT01843777|P1|Participant Flow|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
702023|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
702024|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
702025|NCT01843777|O2|Outcome|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
702026|NCT01843777|O1|Outcome|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
702027|NCT01843777|E2|Reported Event|Treatment|"The treatment group, on the other hand, will use a motivational tool (exploring importance) in a manner that is consistent with the spirit of motivational interviewing.~Treatment: motivational interviewing"
702028|NCT01843777|E1|Reported Event|Standard-of-Care|"The standard-of-care control group will review and practice with the audiologist content such as: 1) information on hearing-aid batteries and how to change them, 2) cleaning/daily care of the hearing aids, and 3) inserting and removing the hearing aids.~Standard-of-Care: the standard of care in audiologic practice"
702029|NCT01843673|B1|Baseline|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
702030|NCT01843673|P1|Participant Flow|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT cone-beam computed tomography: Undergo dual CBCT radiography: Undergo 2-D x-ray with Varian kV OBI radiography: Undergo 2-D x-ray with Brain Lab ExacTrac radiography: Undergo 2-D x-ray with Varian MV OBI electronic portal imaging: Undergo EPID imaging image-guided adaptive radiation therapy: Undergo IGART"
702031|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702032|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702033|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702034|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702035|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702036|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702037|NCT01843673|O3|Outcome|Oblique Brainlab ExacTrac Images|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure ExacTrac gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702130|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702038|NCT01843673|O2|Outcome|Varian CBCT (Cone Beam CT) Imaging|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure CBCT gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702039|NCT01843673|O1|Outcome|Orthogonal Varian kV OBI Image|Patients are first set up for treatment with surface fiducial marks and followed by an automated image guided alignment procedure to achieve better alignment with the planning image. The automated procedure OBI gives two shifts: vertical and lateral. In the absence of a gold standard, our goal is to compare the vertical and lateral shifts recommended by each pair of automated procedures.
702040|NCT01843673|E1|Reported Event|Diagnostic (Imaging Technology)|"Patients undergo FBCT once before treatment and once weekly for a total of 6-7 scans, dual CBCT up to 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian kV OBI 5 times weekly for a total of 33-35 scans, 2-D x-ray with Brain Lab ExacTrac 5 times weekly for a total of 33-35 scans, 2-D x-ray with Varian MV OBI once weekly for a total of 6-7 scans, and EPID imaging up to 5 times weekly for a total of 33-35 scans while undergoing IGART.~computed tomography: Undergo FBCT~cone-beam computed tomography: Undergo dual CBCT~radiography: Undergo 2-D x-ray with Varian kV OBI~radiography: Undergo 2-D x-ray with Brain Lab ExacTrac~radiography: Undergo 2-D x-ray with Varian MV OBI~electronic portal imaging: Undergo EPID imaging~image-guided adaptive radiation therapy: Undergo IGART"
702041|NCT01843660|B1|Baseline|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702042|NCT01843660|P1|Participant Flow|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702043|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702044|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702045|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702046|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702089|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702047|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702048|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702049|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702050|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702051|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702052|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702053|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702054|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702055|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702056|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702057|NCT01843660|O1|Outcome|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702058|NCT01843660|E1|Reported Event|Tramadol Hydrochloride (HCl)-Paracetamol|Participants received 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325 mg) for up to a total duration of 6 hours.
702059|NCT01843465|B1|Baseline|Cryoablation of Atrial Fibrillation|Maneuvers for documenting the disconnection :
702131|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702132|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
702133|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702134|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702135|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
702060|NCT01843465|P1|Participant Flow|Cryoablation of Atrial Fibrillation|"All patients underwent cryoballoon ablation of atrial fibrillation using the Achieve 20mm catheter for real-time documentation of PV potentials.~According to the maneuvers for documenting the disconnection , 4 PV types were defined:~Type 1 - Achieve allowing documentation of PV disconnection in the standard position.~Type 2 - Need of backward/proximal displacement of the Achieve catheter to display PV potentials during cryoenergy application.~Type 3 - No possibility of clear documentation of PV potentials, but capture of PV with pacing Type 4 - no real-time documentation of PV disconnection"
702061|NCT01843465|O1|Outcome|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
702062|NCT01843465|E1|Reported Event|Cryoablation of Atrial Fibrillation|"Maneuvers for documenting the disconnection :~Type 1 pulmonary veins Type 2 pulmonary veins Type 3 pulmonary veins Type 4 pulmonary veins"
702063|NCT01843348|B4|Baseline|Total|Total of all reporting groups
702064|NCT01843348|B3|Baseline|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702065|NCT01843348|B2|Baseline|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702066|NCT01843348|B1|Baseline|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702067|NCT01843348|P3|Participant Flow|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702068|NCT01843348|P2|Participant Flow|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702069|NCT01843348|P1|Participant Flow|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702070|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702071|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702072|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702073|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702074|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702075|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702076|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702077|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702078|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702079|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702080|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702081|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702082|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702083|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702084|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702085|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702086|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702087|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702095|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702096|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702097|NCT01843348|O5|Outcome|CycA+Certican -Tac+MPA - Difference Between Groups|
702098|NCT01843348|O4|Outcome|Tac+Certican - Tac+MPA - Difference Between Groups|
702099|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702100|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702101|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702102|NCT01843348|O3|Outcome|CycA+Certican|Cyclosporin A, Certican, corticosteroids and Simulect
702103|NCT01843348|O2|Outcome|TAC+Certican|Tacrolimus, Certican, corticosteroids and Simulect
702104|NCT01843348|O1|Outcome|TAC+MPA|Tacrolimus, Mycophenolic acid (MPA), corticosteroids and Simulect
702105|NCT01843348|E3|Reported Event|CycA+Certican|CycA+Certican
702106|NCT01843348|E2|Reported Event|Tac+Certican|Tac+Certican
702107|NCT01843348|E1|Reported Event|Tac+MPA|Tac+MPA
702108|NCT01843192|B4|Baseline|Total|Total of all reporting groups
702109|NCT01843192|B3|Baseline|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702110|NCT01843192|B2|Baseline|Lobectomy|Subjects undergoing VATS lobectomy
702111|NCT01843192|B1|Baseline|Wedge Resection|Subjects undergoing VATS wedge resection
702112|NCT01843192|P3|Participant Flow|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702113|NCT01843192|P2|Participant Flow|Lobectomy|Subjects undergoing VATS lobectomy
702114|NCT01843192|P1|Participant Flow|Wedge Resection|Subjects undergoing VATS wedge resection
702115|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702116|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702117|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
702118|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702119|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702120|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
702121|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702122|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702123|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
702124|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702125|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702136|NCT01843192|O3|Outcome|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702137|NCT01843192|O2|Outcome|Lobectomy|Subjects undergoing VATS lobectomy
702138|NCT01843192|O1|Outcome|Wedge Resection|Subjects undergoing VATS wedge resection
702139|NCT01843192|E3|Reported Event|Wedge Resection With Lobectomy|Subjects undergoing VATS wedge resection that also required lobectomy
702140|NCT01843192|E2|Reported Event|Lobectomy|Subjects undergoing VATS lobectomy
702141|NCT01843192|E1|Reported Event|Wedge Resection|Subjects undergoing VATS wedge resection
702142|NCT01842906|B3|Baseline|Total|Total of all reporting groups
702143|NCT01842906|B2|Baseline|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
702144|NCT01842906|B1|Baseline|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
702145|NCT01842906|P2|Participant Flow|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
702146|NCT01842906|P1|Participant Flow|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
702147|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
702148|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
702149|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
702150|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
702151|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
702152|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
702153|NCT01842906|O2|Outcome|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
702207|NCT01842464|P1|Participant Flow|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
702154|NCT01842906|O1|Outcome|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
702155|NCT01842906|E2|Reported Event|Theravent|"A singe use, disposable, positive end expiratory pressure device worn over the nostrils while sleeping.~Theravent: nasal EPAP device"
702156|NCT01842906|E1|Reported Event|Control|"A visibly identical sham device that does not provide positive end expiratory pressure.~Control: Sham device without EPAP"
702157|NCT01842841|B1|Baseline|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702158|NCT01842841|P1|Participant Flow|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 units per kilogram (U/kg), every other week (EOW) administered as an intravenous (IV) infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702159|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702160|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702161|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702162|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702163|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702164|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702165|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702166|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702167|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702168|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702169|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702170|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702242|NCT01841970|E1|Reported Event|HET Arm|
702243|NCT01841697|B3|Baseline|Total|Total of all reporting groups
702171|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702172|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702173|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702174|NCT01842841|O1|Outcome|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702175|NCT01842841|E1|Reported Event|Velaglucerase Alfa (VPRIV®)|Velaglucerase alfa (VPRIV®) 15 to 60 U/kg, EOW, administered as an IV infusion over 60 minutes from Week 53 (2 weeks after the last infusion [Week 51] in Study HGT-GCB-087 [NCT01614574]) to Week 155.
702176|NCT01842646|B1|Baseline|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
702177|NCT01842646|P1|Participant Flow|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
702178|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
702179|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
702180|NCT01842646|O1|Outcome|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
702181|NCT01842646|E1|Reported Event|Experimental: PF-04449913 Treatment|Treatment to be administered on an outpatient basis. All participants to be treated with an oral dose PF-04449913 at 100 mg daily in 4-week cycles for a total of 4 cycles.
702205|NCT01842594|E1|Reported Event|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
702206|NCT01842464|B1|Baseline|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
702182|NCT01842607|B1|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702183|NCT01842607|P1|Participant Flow|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702184|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702185|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702186|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702187|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702188|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702189|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702190|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702191|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702192|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702193|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702194|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702195|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702196|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702197|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702198|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702199|NCT01842607|O1|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702200|NCT01842607|E1|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 milligrams (mg) administered via subcutaneous (SC) injection into the upper arm or thigh approximately every 4 weeks for 12 months. Participants remained on standard of care asthma therapy which could be adjusted during the study at the discretion of the physician.
702201|NCT01842594|B1|Baseline|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
702202|NCT01842594|P1|Participant Flow|Sirolimus and Hydroxychloroquine|Patients received 1 mg of sirolimus (rapamycin, Rapa) and 200 mg of hydroxychloroquine (HCQ) twice a day before a meal for 2 weeks.
702203|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
702204|NCT01842594|O1|Outcome|Sirolimus and Hydroxychloroquine|Patients received 1 mg of Rapa and 200 mg of HCQ twice a day before a meal for 2 weeks.
702208|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
702209|NCT01842464|O1|Outcome|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
702210|NCT01842464|O1|Outcome|Anterior Sacro-Spinous Support|Number of participants with successful Sacro-Spinous Ligaments Anterior Apical Anchoring
702211|NCT01842464|E1|Reported Event|Anterior Sacro-Spinos Support|Anterior Sacro-Spinous Support :
702212|NCT01842438|B3|Baseline|Total|Total of all reporting groups
702213|NCT01842438|B2|Baseline|Control|This group will not receive the intervention during the life-span of the project
702214|NCT01842438|B1|Baseline|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
702215|NCT01842438|P2|Participant Flow|Control|This group will not receive the intervention during the life-span of the project
702216|NCT01842438|P1|Participant Flow|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
702217|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
702218|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
702219|NCT01842438|O4|Outcome|Control: Partners|Did not receive the intervention; mostly females, but one male as there was one same-sex couple participating.
702220|NCT01842438|O3|Outcome|Control: Patient Group|Did not receive the intervention. All males
702221|NCT01842438|O2|Outcome|Intervention: Partners|This group received the intervention during the life-span of the project. Partners only.
702222|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention PATIENTS|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention~This data is patients-only (all males)"
702223|NCT01842438|O2|Outcome|Control|This group will not receive the intervention during the life-span of the project
702224|NCT01842438|O1|Outcome|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
702225|NCT01842438|E2|Reported Event|Control|This group will not receive the intervention during the life-span of the project
702226|NCT01842438|E1|Reported Event|Behavioral: Psychosexual Intervention|"6-sessions of couple support focused on relationships and psychosexual functioning~Behavioral: psychosexual intervention"
702227|NCT01841970|B1|Baseline|HET Arm|"Active arm. A single procedure with HET was used to treat Grade I and Grade II hemorrhoids~HET Bipolar System: The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply."
702228|NCT01841970|P1|Participant Flow|HET Arm|All subjects enrolled into the study were treated with the HET Bipolar System
702229|NCT01841970|O3|Outcome|Month 6|
702230|NCT01841970|O2|Outcome|Month 3|
702231|NCT01841970|O1|Outcome|Month 1|
702232|NCT01841970|O3|Outcome|Month 6|
702233|NCT01841970|O2|Outcome|Month 3|
702234|NCT01841970|O1|Outcome|Month 1|
702235|NCT01841970|O3|Outcome|Month 6|
702236|NCT01841970|O2|Outcome|Month 3|
702237|NCT01841970|O1|Outcome|Month 1|
702238|NCT01841970|O3|Outcome|Month 6|
702239|NCT01841970|O2|Outcome|Month 3|
702240|NCT01841970|O1|Outcome|Month 1|
702241|NCT01841970|O1|Outcome|HET Arm|
702244|NCT01841697|B2|Baseline|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702245|NCT01841697|B1|Baseline|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702246|NCT01841697|P2|Participant Flow|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702247|NCT01841697|P1|Participant Flow|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702248|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702249|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702250|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702251|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702465|NCT01839604|E5|Reported Event|3 mg/kg|given intravenously (Part A & B pooled)
702252|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702253|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702254|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702255|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702256|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702257|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702258|NCT01841697|O2|Outcome|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702259|NCT01841697|O1|Outcome|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702260|NCT01841697|E2|Reported Event|Sitagliptin 100 mg Once Daily|Participants received sitagliptin 100 mg once daily plus placebo to omarigliptin once a week for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702261|NCT01841697|E1|Reported Event|Omarigliptin 25 mg Once Weekly|Participants received omarigliptin 25 mg once a week plus placebo to sitagliptin once daily for 24 weeks. Participants continued pre-study stable dose of metformin (total daily dose ≥1500 mg) throughout the study. Participants may have received glimepiride (total daily dose of 1-6 mg) as rescue therapy.
702273|NCT01841593|P2|Participant Flow|Group B (Amlodipine Then Raltegravir)|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
702274|NCT01841593|P1|Participant Flow|Group A (Raltegravir Then Amlodipine)|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
702275|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702262|NCT01841619|B1|Baseline|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702263|NCT01841619|P1|Participant Flow|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702264|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702265|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702295|NCT01841216|B2|Baseline|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702296|NCT01841216|B1|Baseline|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702266|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702267|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702268|NCT01841619|O1|Outcome|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702269|NCT01841619|E1|Reported Event|IVIg as a Monotherapy|"IVIg will be used as a first line treatment. Topical treatment will be stopped at the beginning of IVIg therapy.~IVIg: All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol."
702270|NCT01841593|B3|Baseline|Total|Total of all reporting groups
702271|NCT01841593|B2|Baseline|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
702272|NCT01841593|B1|Baseline|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
702276|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702277|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702278|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702279|NCT01841593|O2|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702280|NCT01841593|O1|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702281|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702282|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702283|NCT01841593|O4|Outcome|Amlodipine PK (Administered With Raltegravir)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702284|NCT01841593|O3|Outcome|Amlodipine PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702285|NCT01841593|O2|Outcome|Raltegravir PK (Administered With Amlodipine)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702286|NCT01841593|O1|Outcome|Raltegravir PK (Alone)|Combined analysis - groups A & B. No period effect due to order of study treatment periods found.
702287|NCT01841593|E2|Reported Event|Group B|DAYS 1 to 7: amlodipine 5 mg OD DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: raltegravir 400 mg BID
702288|NCT01841593|E1|Reported Event|Group A|DAYS 1 to 7: raltegravir 400 mg BID DAYS 8 to 14: raltegravir 400 mg BID PLUS amlodipine 5 mg OD DAYS 15 to 21: amlodipine 5 mg OD
702289|NCT01841567|B1|Baseline|Dressing|"Mepilex border post. op~Mepilex border post op"
702290|NCT01841567|P1|Participant Flow|Dressing|"Mepilex border post. op~Mepilex border post op"
702291|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op~Mepilex border post op"
702292|NCT01841567|O1|Outcome|Dressing|"Mepilex border post. op~Mepilex border post op"
702293|NCT01841567|E1|Reported Event|Dressing|"Mepilex border post. op~Mepilex border post op"
702294|NCT01841216|B3|Baseline|Total|Total of all reporting groups
702331|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702297|NCT01841216|P2|Participant Flow|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702298|NCT01841216|P1|Participant Flow|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702299|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702300|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702301|NCT01841216|O2|Outcome|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702302|NCT01841216|O1|Outcome|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702303|NCT01841216|E2|Reported Event|Healthy|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702304|NCT01841216|E1|Reported Event|Low Back Pain|"Lower Body Exercises with and without resistance~Lower Body Exercises with and without resistance: lower body exercises with and without resistance designed to activate the gluteal/hip musculature"
702305|NCT01841021|B1|Baseline|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702306|NCT01841021|P1|Participant Flow|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702307|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702308|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702309|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702310|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702311|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702312|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702313|NCT01841021|O1|Outcome|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702314|NCT01841021|E1|Reported Event|Brentuximab Vedotin Treatment|Brentuximab vedotin will be given intravenously with a dose of 1.8 mg/kg every 21 days, over 30 minutes for 16 cycles in the clinic.
702315|NCT01840943|B3|Baseline|Total|Total of all reporting groups
702353|NCT01840605|B2|Baseline|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
702316|NCT01840943|B2|Baseline|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702317|NCT01840943|B1|Baseline|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702318|NCT01840943|P2|Participant Flow|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702319|NCT01840943|P1|Participant Flow|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702320|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702321|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702322|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702323|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702324|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702325|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702326|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702327|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702328|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702329|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702330|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702458|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
702459|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
702332|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702333|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702334|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702335|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702336|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702337|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702338|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702339|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702340|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702341|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702342|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702343|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702344|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702345|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702346|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702347|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702348|NCT01840943|O2|Outcome|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702349|NCT01840943|O1|Outcome|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702350|NCT01840943|E2|Reported Event|Topotecan Hydrocloride (HCl)|Participants received topotecan HCl 1.25 mg per square meter per day, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
702351|NCT01840943|E1|Reported Event|CAELYX|Participants received 50 milligram per square meters (mg/m^2) of Caelyx as a 90-minute or 60 to 90-minute intravenous infusion every 4 weeks.
702352|NCT01840605|B3|Baseline|Total|Total of all reporting groups
702355|NCT01840605|P2|Participant Flow|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
702356|NCT01840605|P1|Participant Flow|TAU-284|TAU-284 10mg twice daily for 2 weeks
702357|NCT01840605|O2|Outcome|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
702358|NCT01840605|O1|Outcome|TAU-284|TAU-284 10mg twice daily for 2 weeks
702359|NCT01840605|E2|Reported Event|Ketotifen Fumarate|Ketotifen fumarate dry syrup 1g twice daily for 2 weeks
702360|NCT01840605|E1|Reported Event|TAU-284|TAU-284 10mg twice daily for 2 weeks
702361|NCT01840410|B3|Baseline|Total|Total of all reporting groups
702362|NCT01840410|B2|Baseline|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702363|NCT01840410|B1|Baseline|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702364|NCT01840410|P2|Participant Flow|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702365|NCT01840410|P1|Participant Flow|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702366|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
702367|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702368|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702369|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
702370|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702460|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
702371|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702372|NCT01840410|O3|Outcome|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
702373|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702374|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702375|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702376|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702377|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702378|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702379|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702380|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702381|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702382|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702383|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702384|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702385|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702386|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702387|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
703007|NCT01836458|E3|Reported Event|Dose 3: 10mg|Single dose of KAE609 10 mg
702388|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702389|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702390|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702391|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702392|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702393|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702394|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702395|NCT01840410|O2|Outcome|Sham Control|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
702396|NCT01840410|O1|Outcome|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702397|NCT01840410|E3|Reported Event|Sham Without Ranibizumab|Participants did not receive ranibizumab at any time during the study.
702398|NCT01840410|E2|Reported Event|Sham With Ranibizumab|Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At month 1, if treatment was needed, sham was administered. At month 2, participants switched to open-label ranibizumab on an as needed basis.
702399|NCT01840410|E1|Reported Event|Ranibizumab|A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
702461|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
702462|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
702400|NCT01840319|B1|Baseline|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
702401|NCT01840319|P1|Participant Flow|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
702402|NCT01840319|O1|Outcome|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
702403|NCT01840319|E1|Reported Event|Tigecycline|Participants who had received tigecycline, alone or in combination in the initial study, for the treatment of a bacterial infection, were retrospectively observed for survival up to 30 days after last dose of tigecycline.
702404|NCT01840072|B3|Baseline|Total|Total of all reporting groups
702405|NCT01840072|B2|Baseline|Usual Care|Discontinue all home BP medications.
702406|NCT01840072|B1|Baseline|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702407|NCT01840072|P2|Participant Flow|Usual Care|Discontinue all home BP medications.
702408|NCT01840072|P1|Participant Flow|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702409|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702410|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
702490|NCT01839279|P3|Participant Flow|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
702491|NCT01839279|P2|Participant Flow|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
702492|NCT01839279|P1|Participant Flow|Tizanidine|
702493|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
702411|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702412|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
702413|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702414|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
702415|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702416|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
702417|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702418|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
702419|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
702463|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
702420|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702421|NCT01840072|O2|Outcome|Usual Care|Discontinue all home BP medications.
702422|NCT01840072|O1|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702423|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702424|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
702425|NCT01840072|O2|Outcome|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702426|NCT01840072|O1|Outcome|Usual Care|Discontinue all home BP medications.
702427|NCT01840072|E2|Reported Event|Usual Care|Discontinue all home BP medications.
702494|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
702495|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
702496|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
702497|NCT01839279|O2|Outcome|Day 14 (Tizanidine 24 mg)|
702498|NCT01839279|O1|Outcome|Day 5 (Tizanidine 8 mg)|
702428|NCT01840072|E1|Reported Event|Active Antihypertensive Treatment|"Active antihypertensive treatment~Active antihypertensive treatment: Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization."
702429|NCT01839695|B1|Baseline|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
702430|NCT01839695|P1|Participant Flow|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
702431|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
702432|NCT01839695|O1|Outcome|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
702433|NCT01839695|E1|Reported Event|Valiant Mona LSA Stent Graft System|"TEVAR procedure using Medtronic Stent Graft >~> Valiant Mona LSA Stent Graft System: All subjects will be implanted with this device"
702434|NCT01839604|B6|Baseline|Total|Total of all reporting groups
702435|NCT01839604|B5|Baseline|3 mg/kg|given intravenously (Part A & B pooled)
702436|NCT01839604|B4|Baseline|2.5 mg/kg|given intravenously Part A
702437|NCT01839604|B3|Baseline|2 mg/kg|given intravenously Part A
702438|NCT01839604|B2|Baseline|1.5 mg/kg|given intravenously. Part A
702439|NCT01839604|B1|Baseline|AZD9150 1mg/kg|Intravenous. Part A.
702440|NCT01839604|P5|Participant Flow|AZD9150 3mg/kg|Pooled over parts A & B
702441|NCT01839604|P4|Participant Flow|AZD9150 2.5mg/kg|Intravenous dosing Part A
702442|NCT01839604|P3|Participant Flow|AZD9150 2mg/kg|Intravenous dosing Part A
702443|NCT01839604|P2|Participant Flow|AZD9150 1.5 mg/kg|Intravenous dosing Part A
702444|NCT01839604|P1|Participant Flow|AZD9150 1mg/kg|Intravenous. Part A.
702445|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
702446|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
702447|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
702448|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
702449|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
702450|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
702451|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
702452|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
702453|NCT01839604|O2|Outcome|1.5 mg/kg|given intravenously. Part A
702454|NCT01839604|O1|Outcome|AZD9150 1mg/kg|Intravenous. Part A.
702455|NCT01839604|O5|Outcome|3 mg/kg|given intravenously (Part A & B pooled)
702456|NCT01839604|O4|Outcome|2.5 mg/kg|given intravenously Part A
702457|NCT01839604|O3|Outcome|2 mg/kg|given intravenously Part A
702470|NCT01839318|B1|Baseline|Overall|Nelfilcon A contact lenses, etafilcon A contact lenses, and omafilcon A contact lenses worn in a cross-over assignment.
702471|NCT01839318|P6|Participant Flow|Sequence 6|Etafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
702472|NCT01839318|P5|Participant Flow|Sequence 5|Etafilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
702473|NCT01839318|P4|Participant Flow|Sequence 4|Nelfilcon A contact lenses worn first, followed by omafilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
702474|NCT01839318|P3|Participant Flow|Sequence 3|Nelfilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then omafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
702475|NCT01839318|P2|Participant Flow|Sequence 2|Omafilcon A contact lenses worn first, followed by etafilcon A contact lenses worn second, then nelfilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
702476|NCT01839318|P1|Participant Flow|Sequence 1|Omafilcon A contact lenses worn first, followed by nelfilcon A contact lenses worn second, then etafilcon A contact lenses worn last. Each product worn for 1 day, 12 hours.
702477|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702478|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702479|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702480|NCT01839318|O3|Outcome|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702481|NCT01839318|O2|Outcome|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702482|NCT01839318|O1|Outcome|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702483|NCT01839318|E3|Reported Event|Proclear 1 Day|Omafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702484|NCT01839318|E2|Reported Event|1-DAY ACUVUE MOIST|Etafilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702485|NCT01839318|E1|Reported Event|DAILIES AquaComfort Plus|Nelfilcon A contact lenses worn in a randomized order for 1 day, 12 hours
702486|NCT01839279|B4|Baseline|Total|Total of all reporting groups
702487|NCT01839279|B3|Baseline|Initial Moxifloxacin and Crossover to Placebo|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
702488|NCT01839279|B2|Baseline|Initial Placebo and Crossover to Moxifloxacin|Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
702489|NCT01839279|B1|Baseline|Tizanidine|
702499|NCT01839279|O1|Outcome|Tizanidine|
702500|NCT01839279|O3|Outcome|Tizanidine 8 mg Placebo-corrected|70 subjects Tizanidine 8 mg single dose, 63 subjects placebo used for analysis.
702501|NCT01839279|O2|Outcome|Tizanidine Placebo 8 mg|63 subjects placebo used for analysis.
702502|NCT01839279|O1|Outcome|Tizanidine 8 mg|70 subjects Tizanidine 8 mg single dose.
702503|NCT01839279|O3|Outcome|Tizanidine 24 mg Placebo-corrected|60 subjects Tizanidine 24 mg single dose, 61 subjects placebo used for the analysis.
702504|NCT01839279|O2|Outcome|Tizanidine Placebo 24 mg|61 subjects placebo used for the analysis.
702505|NCT01839279|O1|Outcome|Tizanidine 24 mg|60 subjects Tizanidine 24 mg single dose
702506|NCT01839279|E4|Reported Event|Placebo and Moxifloxacin Groups Combined|
702507|NCT01839279|E3|Reported Event|Initial Moxifloxacin and Crossover to Placebo|
702508|NCT01839279|E2|Reported Event|Initial Placebo and Crossover to Moxifloxacin|
702509|NCT01839279|E1|Reported Event|Tizanidine|
702510|NCT01838980|B1|Baseline|Colonoscopy|Motus GI Clean-Up Device
702511|NCT01838980|P1|Participant Flow|Colonoscopy|Motus GI Clean-Up Device
702512|NCT01838980|O1|Outcome|Colonoscopy|Motus GI Clean-Up Device
702513|NCT01838980|E1|Reported Event|Colonoscopy|Motus GI Clean-Up Device
702514|NCT01838941|B1|Baseline|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
702515|NCT01838941|P1|Participant Flow|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
702516|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
702615|NCT01838590|B2|Baseline|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
702616|NCT01838590|B1|Baseline|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
702517|NCT01838941|O1|Outcome|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
702518|NCT01838941|E1|Reported Event|Betaine|"Betaine will be given orally to all participants and dose will be adjusted to body weight.~Betaine: Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
702519|NCT01838694|B3|Baseline|Total|Total of all reporting groups
702520|NCT01838694|B2|Baseline|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
702521|NCT01838694|B1|Baseline|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
702522|NCT01838694|P2|Participant Flow|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range of 10mg twice weekly to 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
702523|NCT01838694|P1|Participant Flow|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
702524|NCT01838694|O5|Outcome|Ala-Cpn10 - 30mgs in Moderate SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
702525|NCT01838694|O4|Outcome|Ala-Cpn10 - 100mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 100mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
702526|NCT01838694|O3|Outcome|Ala-Cpn10 - 30mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 30mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
702527|NCT01838694|O2|Outcome|Ala-Cpn10 - 10mgs in Mild SLE|"Recombinant minimally modified Chaperonin10 (Cpn10) 10mg twice weekly administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
702528|NCT01838694|O1|Outcome|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
702529|NCT01838694|E2|Reported Event|Ala-Cpn10|"Recombinant minimally modified Chaperonin10 (Cpn10) Multiple doses in the range (0.16mg/kg [10mg twice weekly] to 5mg/kg [300mg twice weekly]) administered intravenously by infusion over 60 minutes.~Ala-Cpn10"
702530|NCT01838694|E1|Reported Event|Placebo|"Multiple doses of matched vehicle (no active ingredients) administered intravenously over 60 minutes.~Placebo"
702531|NCT01838642|B1|Baseline|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702532|NCT01838642|P1|Participant Flow|RET Mutation Positive Participants.|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702533|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702534|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702535|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702536|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702537|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702538|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702539|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702540|NCT01838642|O1|Outcome|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702541|NCT01838642|E1|Reported Event|RET Mutation Positive Participants|"Rearranged during transfection) (RET)~Ponatinib: Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting."
702542|NCT01838616|B3|Baseline|Total|Total of all reporting groups
702543|NCT01838616|B2|Baseline|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702544|NCT01838616|B1|Baseline|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702545|NCT01838616|P2|Participant Flow|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702546|NCT01838616|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702547|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702548|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702549|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702550|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702653|NCT01838213|B2|Baseline|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
702551|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702552|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702553|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702554|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702555|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702556|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702617|NCT01838590|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
702557|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702558|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702559|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702560|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702561|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702562|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702563|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702564|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702695|NCT01837966|B3|Baseline|Total|Total of all reporting groups
702565|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702566|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702567|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702568|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702569|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702570|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702618|NCT01838590|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
702571|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702572|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702573|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702574|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702575|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702576|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702577|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702578|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702579|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702580|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702581|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702582|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702583|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702584|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702619|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
702827|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702585|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702586|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702587|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702588|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702589|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702590|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702591|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702592|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702593|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702594|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702595|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702596|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702597|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702598|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702620|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
702828|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702599|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702600|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702601|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702602|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702603|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702604|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702605|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702606|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702607|NCT01838616|O2|Outcome|Oxycodone/Naloxone Prolonged Release|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702608|NCT01838616|O1|Outcome|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks
702609|NCT01838616|E3|Reported Event|Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment|Participants in the oxycodone/naloxone PR treatment arm that did not reach the minimum target of titration or experiencing intolerable side effects at the end of the Titration Period could be switched to the Pick-up Arm. They could also enter the Pick-up Arm at any time during the Titration Period or Continuation Period, via an unscheduled visit, due to lack of tolerability or lack of efficacy under treatment with oxycodone/naloxone PR. Participants were directly switched from oxycodone/naloxone PR to tapentadol PR using an equianalgesic ratio of 1:5 (oxycodone : tapentadol), together with a down-titration step under tapentadol PR (except for participants on oxycodone/naloxone PR 10 mg/5 mg twice daily).
702610|NCT01838616|E2|Reported Event|Oxycodone/Naloxone Prolonged Release (PR)|All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702611|NCT01838616|E1|Reported Event|Tapentadol Prolonged Release (PR)|All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
702612|NCT01838590|B5|Baseline|Total|Total of all reporting groups
702613|NCT01838590|B4|Baseline|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
702614|NCT01838590|B3|Baseline|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
702621|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
702622|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
702623|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
702624|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
702625|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
702626|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
702627|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
702628|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
702629|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
702630|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
702631|NCT01838590|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
702632|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
702633|NCT01838590|O4|Outcome|SOF+RBV 24 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
702634|NCT01838590|O3|Outcome|SOF+RBV 24 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
702635|NCT01838590|O2|Outcome|SOF+RBV 12 Weeks, TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
702636|NCT01838590|O1|Outcome|SOF+RBV 12 Weeks, TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
702637|NCT01838590|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
702638|NCT01838590|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
702639|NCT01838499|B3|Baseline|Total|Total of all reporting groups
702640|NCT01838499|B2|Baseline|Saline|SC injection
702641|NCT01838499|B1|Baseline|MEDI8968|SC injection
702642|NCT01838499|P2|Participant Flow|Saline|SC injection
702643|NCT01838499|P1|Participant Flow|MEDI8968|SC injection
702644|NCT01838499|O2|Outcome|Saline|SC injection
702645|NCT01838499|O1|Outcome|MEDI8968|SC injection
702646|NCT01838499|O2|Outcome|Saline|SC injection
702647|NCT01838499|O1|Outcome|MEDI8968|SC injection
702648|NCT01838499|O2|Outcome|Saline|SC injection
702649|NCT01838499|O1|Outcome|MEDI8968|SC injection
702650|NCT01838499|E2|Reported Event|Saline|SC injection
702651|NCT01838499|E1|Reported Event|MEDI8968|SC injection
702652|NCT01838213|B3|Baseline|Total|Total of all reporting groups
702654|NCT01838213|B1|Baseline|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
702655|NCT01838213|P2|Participant Flow|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
702656|NCT01838213|P1|Participant Flow|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
702657|NCT01838213|O2|Outcome|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
702658|NCT01838213|O1|Outcome|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
702659|NCT01838213|E2|Reported Event|Patients With UTI Caused by Non-ESBL-producing E. Coli|Patients with UTI caused by non-ESBL-producing E. coli
702660|NCT01838213|E1|Reported Event|Patients With UTI Caused by Extended-spectrum β-lactamase-prod|Patients with UTI caused by extended-spectrum β-lactamase-producing E. coli
702661|NCT01838044|B3|Baseline|Total|Total of all reporting groups
702662|NCT01838044|B2|Baseline|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702663|NCT01838044|B1|Baseline|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702718|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702829|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702664|NCT01838044|P2|Participant Flow|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702665|NCT01838044|P1|Participant Flow|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702666|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702667|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702668|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702696|NCT01837966|B2|Baseline|Placebo|"Placebo - unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
702697|NCT01837966|B1|Baseline|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
702698|NCT01837966|P2|Participant Flow|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy"
702669|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702670|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702671|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702672|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702719|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702720|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702830|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702673|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702674|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702675|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702676|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702677|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702678|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702679|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702680|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702681|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702721|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702722|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702723|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702682|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702683|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702684|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702685|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702699|NCT01837966|P1|Participant Flow|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy"
702700|NCT01837966|O2|Outcome|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
702701|NCT01837966|O1|Outcome|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
702702|NCT01837966|E2|Reported Event|Placebo|"Placebo -- unscented oil aromatherapy~Placebo: 2 drops unscented mineral oil for aromatherapy~There were no adverse events for this arm."
702686|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702687|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702688|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702689|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702690|NCT01838044|O1|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702724|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702725|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702831|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702691|NCT01838044|O2|Outcome|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702692|NCT01838044|O1|Outcome|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702693|NCT01838044|E2|Reported Event|Arm B|During Period 1, participants in Arm B were administered a daily fixed dose of celecoxib 200 mg and placebo of pregabalin for 5 weeks (during Weeks 1, 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Participants in Arm B were initiated on pregabalin 150 mg (75 mg BID) daily for 1 week, before pregabalin was up‑titrated to 300 mg (150 mg BID) daily. All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702694|NCT01838044|E1|Reported Event|Arm A|During Period 1, participants in Arm A were administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg twice-daily [BID]) for 1 week followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks (during Weeks 2, 3, 4 and 5). During Period 2, all participants were administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). All participants completed a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose was decreased to 150 mg (75 mg BID) daily and participants had participated in a follow up visit for a final safety assessment.
702703|NCT01837966|E1|Reported Event|Lavender Oil|"Lavender oil aromatherapy~Lavender oil: 2 drops for aromatherapy~There were no adverse events for this arm."
702704|NCT01837797|B4|Baseline|Total|Total of all reporting groups
702705|NCT01837797|B3|Baseline|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
702706|NCT01837797|B2|Baseline|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
702707|NCT01837797|B1|Baseline|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702708|NCT01837797|P5|Participant Flow|Period 3 Placebo and ADT|"Placebo adjunct to open-label treatment with commercially available antidepressant treatment (ADT)~Placebo: Once daily, tablets, orally"
702709|NCT01837797|P4|Participant Flow|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702710|NCT01837797|P3|Participant Flow|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702711|NCT01837797|P2|Participant Flow|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702712|NCT01837797|P1|Participant Flow|Period 1 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702713|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702714|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702715|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702716|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702717|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702824|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702825|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702726|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702727|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702728|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702729|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702730|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702731|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702732|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702733|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702734|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702735|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702736|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702737|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702738|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702739|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702740|NCT01837797|O3|Outcome|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 3 mg once daily, tablets, orally"
702741|NCT01837797|O2|Outcome|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available ADT~Brexpiprazole: 1 mg once daily, tablets, orally"
702742|NCT01837797|O1|Outcome|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
702743|NCT01837797|E3|Reported Event|Period 2 Brexpiprazole 3 mg and ADT|"Brexpiprazole 3 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 3 mg once daily, tablets, orally"
702744|NCT01837797|E2|Reported Event|Period 2 Brexpiprazole 1 mg and ADT|"Brexpiprazole 1 mg adjunct to open-label treatment with a commercially available antidepressant (ADT)~Brexpiprazole: 1 mg once daily, tablets, orally"
702745|NCT01837797|E1|Reported Event|Period 2 Placebo and ADT|"Placebo adjunct to open-label treatment with a commercially available antidepressant (ADT)~Placebo: Once daily, tablets, orally"
703008|NCT01836458|E2|Reported Event|Dose 2: 20mg|Single dose of KAE609 20 mg
702746|NCT01837719|B1|Baseline|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 29. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
702747|NCT01837719|P1|Participant Flow|All Participants Who Received Treatment|All participants who received atazanavir with cobicistat in 1 of 8 treatment sequences (ABCDE, ABDCE, BACDE, BADCE, ABCD, ABDC, BACD, or BADC). Treatment A: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8. Treatment B: Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8. Treatment C: Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day15 or 22. Treatment D: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22. Treatment E: Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
702748|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702749|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702750|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702751|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702752|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702753|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
702754|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
702755|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702756|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702757|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702758|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
702759|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702760|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702761|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702762|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702763|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high fat meal on Day 29
702764|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or22
702765|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702766|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702767|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702768|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702769|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702770|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702771|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702772|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
703009|NCT01836458|E1|Reported Event|Dose 1: 30mg|Single dose of KAE609 30 mg
702773|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702774|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702775|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702776|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702777|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702778|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702779|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day15 or 22
702780|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702781|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702782|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702783|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702784|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702785|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702786|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702787|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702826|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702788|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702789|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702790|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702791|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702792|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702793|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702794|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702795|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702796|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702797|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702798|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702799|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702800|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
702801|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702802|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702803|NCT01837719|O5|Outcome|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29
702804|NCT01837719|O4|Outcome|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22
702805|NCT01837719|O3|Outcome|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22
703237|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
702806|NCT01837719|O2|Outcome|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8
702807|NCT01837719|O1|Outcome|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, following a light meal on Day 1 or 8
702808|NCT01837719|E5|Reported Event|Treatment E: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, following a high-fat meal on Day 29.
702809|NCT01837719|E4|Reported Event|Treatment D: Atazanavir/Cobicistat FDC|Participants received a single FDC dose of atazanavir, 300 mg/cobicistat, 150 mg, in the fasted state on Day 15 or 22.
702810|NCT01837719|E3|Reported Event|Treatment C: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat,150 mg as tablet, in the fasted state on Day 15 or 22.
702811|NCT01837719|E2|Reported Event|Treatment B: Atazanavir/Cobicistat FDC|Participants received a single fixed-dose combination (FDC) of atazanavir, 300 mg/cobicistat, 150 mg, following a light meal on Day 1 or 8.
702812|NCT01837719|E1|Reported Event|Treatment A: Atazanavir + Cobicistat Coadministered|Participants received a single dose of atazanavir, 300 mg as capsule, coadministered with cobicistat, 150 mg as tablet, following a light meal on Day 1 or 8.
702813|NCT01837680|B3|Baseline|Total|Total of all reporting groups
702814|NCT01837680|B2|Baseline|Levemir|Insulin detemir (IDet)
702815|NCT01837680|B1|Baseline|Insulin NPH|Insulin neutral protamine Hagedorn
702816|NCT01837680|P2|Participant Flow|Levemir|Insulin detemir (IDet) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
702817|NCT01837680|P1|Participant Flow|Insulin NPH|Insulin neutral protamine Hagedorn (NPH) - Current weight was obtained at the visit and initial daily total insulin dose was determined based on patient weight (in kilograms) and trimester. In the first trimester, patient weight was multiplied by 0.7, in the second trimester by 0.8, and in the third trimester by 0.9 for the total daily dose of insulin (in units). Of the total daily insulin dose, 60% was allotted to the morning total dose of insulin, while the remaining 40% allotted to the evening total dose.
702818|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702819|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702820|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702821|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702822|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702823|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702833|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702834|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702835|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702836|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702837|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702838|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702839|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702840|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702841|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702842|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702843|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702844|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702845|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702846|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702847|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702848|NCT01837680|O2|Outcome|Levemir|Insulin detemir (IDet)
702849|NCT01837680|O1|Outcome|Insulin NPH|Insulin neutral protamine Hagedorn
702850|NCT01837680|E2|Reported Event|Levemir|Insulin detemir (IDet)
702851|NCT01837680|E1|Reported Event|Insulin NPH|Insulin neutral protamine Hagedorn
702852|NCT01837550|B3|Baseline|Total|Total of all reporting groups
702853|NCT01837550|B2|Baseline|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
702854|NCT01837550|B1|Baseline|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
702855|NCT01837550|P2|Participant Flow|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
702856|NCT01837550|P1|Participant Flow|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
702857|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
702891|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702858|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
702859|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
702860|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
702861|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
702862|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
702863|NCT01837550|O2|Outcome|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
702864|NCT01837550|O1|Outcome|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
702865|NCT01837550|E2|Reported Event|Control Group|"no professional support~Control group: The control group will only have access to the book's content via the Internet and will be asked to read and evaluate the content."
702866|NCT01837550|E1|Reported Event|Intervention Group|Professional support via Internet Intervention group: The intervention group is going to have access to a book and to a prepared compendium about communication strategies via the Internet and will receive weekly topic-based reading instructions related to the different chapters of the book or the compendium. The group will also have access to online and telephone support and access to an online discussion forum where new discussion topics will be posted each week. The project leader will evaluate the weekly data via the Internet.
702867|NCT01837537|B1|Baseline|no Treatment|no treatment, prospective observational
702868|NCT01837537|P1|Participant Flow|no Treatment|no treatment, prospective observational
702869|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
702870|NCT01837537|O1|Outcome|no Treatment|no treatment, prospective observational
702871|NCT01837537|E1|Reported Event|no Treatment|no treatment, prospective observational
702872|NCT01837524|B3|Baseline|Total|Total of all reporting groups
702873|NCT01837524|B2|Baseline|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
702874|NCT01837524|B1|Baseline|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
702875|NCT01837524|P2|Participant Flow|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
703238|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
702876|NCT01837524|P1|Participant Flow|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
702877|NCT01837524|O2|Outcome|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
702878|NCT01837524|O1|Outcome|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
702912|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
702913|NCT01836809|O1|Outcome|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide"
702914|NCT01836809|E4|Reported Event|LVAD: Placebo|"Control arm of the LVAD group~randomized to receive placebo"
702915|NCT01836809|E3|Reported Event|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
702916|NCT01836809|E2|Reported Event|Total Artificial Heart: Placebo|"Control arm of the Total Artificial Heart group~randomized to receive placebo"
702917|NCT01836809|E1|Reported Event|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to receive nesiritide 0.005 mcg/kg/min without bolus"
702879|NCT01837524|E2|Reported Event|Office-Based Visit Arm|"27 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted at one of our medical office buildings. These in-person visits were conducted monthly over a 3 month period. The information delivered in the visits will included how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~In-Office Dietitian Visits: Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period."
702880|NCT01837524|E1|Reported Event|Grocery-Store-Based Visit Arm|"28 participants were randomized to this arm. They were assigned to receive a baseline 30-minute phone call with the study dietitian to determine their current health problems, dietary patterns, shopping and cooking habits and health goals. They were then scheduled for 3 in-person visits with the dietitian conducted during grocery shopping trips at a local supermarket. These in-person visits were to be conducted monthly over a 3 month period. The information delivered in the visits was similar in content to that delivered in an in-office visit, including how to pick the best types of foods or ingredients for a given health condition, how to read and understand food labels, healthy recipes, how to track food and drink intake, and basic nutritional knowledge.~KP Personal Shopper Visits: Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care."
702881|NCT01836809|B5|Baseline|Total|Total of all reporting groups
702882|NCT01836809|B4|Baseline|LVAD: Placebo|"Control arm of the LVAD group~randomized to placebo"
702883|NCT01836809|B3|Baseline|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to nesiritide"
702884|NCT01836809|B2|Baseline|Total Artificial Heart: Placebo|"Total Artificial Heart group~randomized to placebo"
702885|NCT01836809|B1|Baseline|Total Artificial Heart|"Active arm of the Total Artificial Heart group~randomized to nesiritide"
702886|NCT01836809|P4|Participant Flow|LVAD: Placebo|This arm will consist of subjects who received an LVAD and will be randomized to placebo
702887|NCT01836809|P3|Participant Flow|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
702888|NCT01836809|P2|Participant Flow|Total Artificial Heart: Placebo|This arm included subject who received a total artificial heart and will be randomized receive placebo
702889|NCT01836809|P1|Participant Flow|Total Artificial Heart|"Active arm of Total Artificial Heart group~randomized to receive nesiritide at 0.005 mcg/kg/min without a bolus"
702890|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
702892|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
702893|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702894|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
702895|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702896|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
702897|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702898|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
702899|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702900|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
702901|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702902|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
702903|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702904|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
702905|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702906|NCT01836809|O4|Outcome|LVAD: Placebo|Control arm for subjects receiving LVAD and randomized to placebo
702907|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702908|NCT01836809|O2|Outcome|Total Artificial Heart: Placebo|Control arm for subjects receiving the Total Artificial Heart and randomized to receive placebo
702909|NCT01836809|O1|Outcome|Total Artificial Heart|"Nesiritide~nesiritide: nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours."
702910|NCT01836809|O4|Outcome|LVAD: Placebo|"Active arm of the LVAD group~randomized to receive placebo"
702911|NCT01836809|O3|Outcome|LVAD: Nesiritide|"Active arm of the LVAD group~randomized to receive nesiritide"
702919|NCT01836523|B4|Baseline|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
702920|NCT01836523|B3|Baseline|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702921|NCT01836523|B2|Baseline|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702922|NCT01836523|B1|Baseline|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
702923|NCT01836523|P4|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
702924|NCT01836523|P3|Participant Flow|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702925|NCT01836523|P2|Participant Flow|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702926|NCT01836523|P1|Participant Flow|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
702927|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
702928|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702929|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
703003|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
702930|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
702931|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
702932|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702933|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702934|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
702935|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
702936|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702937|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702938|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
702939|NCT01836523|O4|Outcome|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
702940|NCT01836523|O3|Outcome|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702941|NCT01836523|O2|Outcome|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702942|NCT01836523|O1|Outcome|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
702943|NCT01836523|E4|Reported Event|Placebo|Subjects received placebo (matched to liraglutide 0.6, 1.2 and 1.8 mg) OD subcutaneously as an add-on to their pre-trial insulin treatment. Placebo 0.1 mL (placebo matched to liraglutide 0.6 mg): Subjects received 0.1 mL liraglutide placebo for 52 weeks. Placebo 0.2 mL (placebo matched to liraglutide 1.2 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL up to week 52. Placebo 0.3 mL (placebo matched to liraglutide 1.8 mg): Subjects received 0.1 mL for 2 weeks followed by 0.2 mL for next 2 weeks and 0.3 mL up to week 52. All the 3 placebo doses were pooled for data analysis.
702944|NCT01836523|E3|Reported Event|Liraglutide 1.8 mg|Liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously for 2 weeks (weeks 2-4) followed by 1.8 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702945|NCT01836523|E2|Reported Event|Liraglutide 1.2 mg|Subjects received liraglutide 0.6 mg OD subcutaneously for 2 weeks followed by 1.2 mg OD subcutaneously up to week 52 in addition to their pre-trial insulin treatment.
702946|NCT01836523|E1|Reported Event|Liraglutide 0.6 mg|Subjects received liraglutide 0.6 mg once daily (OD) subcutaneously for 52 weeks in addition to their pre-trial insulin treatment.
702947|NCT01836471|B6|Baseline|Total|Total of all reporting groups
702948|NCT01836471|B5|Baseline|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702949|NCT01836471|B4|Baseline|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702950|NCT01836471|B3|Baseline|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702951|NCT01836471|B2|Baseline|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702952|NCT01836471|B1|Baseline|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702953|NCT01836471|P5|Participant Flow|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702954|NCT01836471|P4|Participant Flow|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702955|NCT01836471|P3|Participant Flow|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
703004|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
702956|NCT01836471|P2|Participant Flow|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702957|NCT01836471|P1|Participant Flow|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702958|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702959|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702960|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702961|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702962|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702963|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702964|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702965|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702966|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702967|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702968|NCT01836471|O5|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702969|NCT01836471|O4|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702970|NCT01836471|O3|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702971|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
703202|NCT01835015|P2|Participant Flow|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
702972|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702973|NCT01836471|O3|Outcome|Placebo Atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702974|NCT01836471|O2|Outcome|Fluticasone 150 µg Bid Atopic|Fluticasone 150 µg plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702975|NCT01836471|O1|Outcome|QAW039 450 mg qd Atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Atopic patients randomized in ratio of approximately 1:1:1 to QAW039 or fluticasone or placebo.
702976|NCT01836471|O2|Outcome|Placebo Non-atopic|Placebo to QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702977|NCT01836471|O1|Outcome|QAW039 450 mg qd Non-atopic|QAW039 450 mg qd plus background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1 to QAW039 or placebo.
702978|NCT01836471|E3|Reported Event|Placebo|Placebo
702979|NCT01836471|E2|Reported Event|Fluticasone 150 mcg Bid|Fluticasone 150 mcg bid
702980|NCT01836471|E1|Reported Event|QAW039 450 mg qd|QAW039 450 mg qd
702981|NCT01836458|B5|Baseline|Total|Total of all reporting groups
702982|NCT01836458|B4|Baseline|Dose 4: 15 mg|Single dose of KAE609 15 mg
702983|NCT01836458|B3|Baseline|Dose 3: 10 mg|Single dose of KAE609 10 mg
702984|NCT01836458|B2|Baseline|Dose 2: 20 mg|Single dose of KAE609 20 mg
702985|NCT01836458|B1|Baseline|Dose 1: 30 mg|Single dose of KAE609 30 mg
702986|NCT01836458|P4|Participant Flow|Dose 4: 15 mg|Single dose of KAE609 15 mg
702987|NCT01836458|P3|Participant Flow|Dose 3: 10 mg|Single dose of KAE609 10 mg
702988|NCT01836458|P2|Participant Flow|Dose 2: 20 mg|Single dose of KAE609 20 mg
702989|NCT01836458|P1|Participant Flow|Dose 1: 30 mg|Single dose of KAE609 30 mg
702990|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
702991|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
702992|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
702993|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
702994|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
702995|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
702996|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
702997|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
702998|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
702999|NCT01836458|O3|Outcome|Dose 3: 10 mg|Single dose of KAE609 10 mg
703000|NCT01836458|O2|Outcome|Dose 2: 20 mg|Single dose of KAE609 20 mg
703001|NCT01836458|O1|Outcome|Dose 1: 30 mg|Single dose of KAE609 30 mg
703002|NCT01836458|O4|Outcome|Dose 4: 15 mg|Single dose of KAE609 15 mg
703010|NCT01836133|B1|Baseline|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
703011|NCT01836133|P1|Participant Flow|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
703012|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
703013|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
703014|NCT01836133|O1|Outcome|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
703015|NCT01836133|E1|Reported Event|Erlotinib 150 mg|Participants received 150 mg erlotinib once daily, orally, as tablets, until disease progression or unacceptable toxicity, up to 3 years.
703016|NCT01836042|B4|Baseline|Total|Total of all reporting groups
703017|NCT01836042|B3|Baseline|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
703018|NCT01836042|B2|Baseline|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
703019|NCT01836042|B1|Baseline|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
703020|NCT01836042|P3|Participant Flow|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
703021|NCT01836042|P2|Participant Flow|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
703022|NCT01836042|P1|Participant Flow|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
703023|NCT01836042|O3|Outcome|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
703024|NCT01836042|O2|Outcome|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
703025|NCT01836042|O1|Outcome|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
703026|NCT01836042|E3|Reported Event|Non-randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients not randomized to group
703027|NCT01836042|E2|Reported Event|Randomized Cataract Surgery|Cataract surgery alone, patients randomized to group
703203|NCT01835015|P1|Participant Flow|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703028|NCT01836042|E1|Reported Event|Randomized iStent|Implantation of one iStent in conjunction with cataract surgery, patients randomized to group
703029|NCT01835912|B1|Baseline|All Study Participants|"Acute: dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Acute Placebo: 500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)~Chronic: 3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)~Chronic Placebo: 3 days of 500 milliliters flavoured water and the 4th day 500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)"
703030|NCT01835912|P1|Participant Flow|All Study Participants|"Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic) and their corresponding placebos.~4 arms: Acute, Acute Placebo, Chronic, Chronic Placebo~Acute: 0.5 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Acute Placebo: 500 milliliters of flavoured water~Chronic: 3 days of 0.1 g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 millilitres of flavoured water~Chronic Placebo: 3 days of 500 millilitres of flavoured water and 4th day 500 millilitres of flavoured water"
703031|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703032|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
703033|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703034|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
703035|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703036|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
703037|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703038|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
703039|NCT01835912|O4|Outcome|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703040|NCT01835912|O3|Outcome|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
703041|NCT01835912|O2|Outcome|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703042|NCT01835912|O1|Outcome|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
703043|NCT01835912|E4|Reported Event|Sodium Citrate Dihydrate Chronic|"3 days of 0.1g/kg of body mass of sodium citrate and 4th day at 0.3 g/kg of body mass of sodium citrate in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703044|NCT01835912|E3|Reported Event|Flavoured Water Placebo for Chronic Dosing|500 milliliters flavoured water (placebo for the chronic dosing intervention of sodium citrate)
703045|NCT01835912|E2|Reported Event|Sodium Citrate Dihydrate Acute|"dose: 0.5 g/kg of body mass dissolved in 500 milliliters of flavoured water~Sodium Citrate Dihydrate: Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)"
703046|NCT01835912|E1|Reported Event|Flavoured Water Placebo for Acute Dosing|500 milliliters flavoured water (placebo for the acute dosing intervention of sodium citrate)
703047|NCT01835899|B4|Baseline|Total|Total of all reporting groups
703048|NCT01835899|B3|Baseline|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703049|NCT01835899|B2|Baseline|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703050|NCT01835899|B1|Baseline|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
703051|NCT01835899|P3|Participant Flow|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703052|NCT01835899|P2|Participant Flow|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703053|NCT01835899|P1|Participant Flow|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
703054|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703055|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703056|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703057|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703058|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703059|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703060|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703061|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703062|NCT01835899|O2|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703063|NCT01835899|O1|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703064|NCT01835899|O3|Outcome|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703065|NCT01835899|O2|Outcome|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703066|NCT01835899|O1|Outcome|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
703067|NCT01835899|E3|Reported Event|6 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 6 mg PfOS (to have 24 mL volume of oral solution in total).
703068|NCT01835899|E2|Reported Event|1 mg BI 1015550|Subjects were orally administered twice daily with BI 1015550 1 mg PfOS (to have 4 mL volume of oral solution in total).
703069|NCT01835899|E1|Reported Event|Placebo to BI 1015550|Subjects were orally administered twice daily with matching Placebo to BI 1015550 Powder for oral solution (PFOS), to have Volume identical to the active drug of the respective dose group.
703070|NCT01835756|B3|Baseline|Total|Total of all reporting groups
703071|NCT01835756|B2|Baseline|Placebo Laser|The Placebo Laser has the same appearance and treatment application as the Erchonia MLS but does not emit any therapeutic light.
703072|NCT01835756|B1|Baseline|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
703073|NCT01835756|P2|Participant Flow|Placebo Laser|The Placebo Laser has the same appearance as the Erchonia MLS but does not emit any therapeutic light.
703074|NCT01835756|P1|Participant Flow|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. It is applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
703075|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
703076|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
703077|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
703078|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
703079|NCT01835756|O2|Outcome|Placebo Laser|The Placebo Laser has the same appearance and administration application as the active Erchonia MLS but does not emit any therapeutic light.
703080|NCT01835756|O1|Outcome|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light, applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
703081|NCT01835756|E2|Reported Event|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
703082|NCT01835756|E1|Reported Event|Erchonia MLS|The Erchonia MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light applied to the lower back and hips area for 30 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
703083|NCT01835743|B3|Baseline|Total|Total of all reporting groups
703084|NCT01835743|B2|Baseline|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703085|NCT01835743|B1|Baseline|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703086|NCT01835743|P2|Participant Flow|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703087|NCT01835743|P1|Participant Flow|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703088|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703152|NCT01835262|E2|Reported Event|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
703089|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703090|NCT01835743|O2|Outcome|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703091|NCT01835743|O1|Outcome|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703092|NCT01835743|E2|Reported Event|Placebo Laser|"The Placebo Laser is identical in appearance and operation to the Erchonia HPS Laser but does not emit any therapeutic light.~Placebo Laser: The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703093|NCT01835743|E1|Reported Event|Erchonia HPS Laser|"The Erchonia HPS Laser contains 3 independent diodes mounted in scanner devices and positioned equidistant from each other and titled at a 30 degree angle. Each scanner emits 17 milliwatts (mW), 635 nm of red laser light.~Erchonia HPS Laser: The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration."
703094|NCT01835496|B1|Baseline|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703095|NCT01835496|P1|Participant Flow|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703096|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703097|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703098|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703099|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703100|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703101|NCT01835496|O1|Outcome|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703102|NCT01835496|E1|Reported Event|Ferriprox|A single dose of 1500 mg of Ferriprox (three 500 mg tablets) administered under fasting conditions
703103|NCT01835470|B1|Baseline|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703104|NCT01835470|P1|Participant Flow|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703239|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703105|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703106|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703107|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703108|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
703109|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703110|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703111|NCT01835470|O1|Outcome|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study
703112|NCT01835470|E1|Reported Event|Abatacept|Abatacept 10 mg/kg (for body weight less than 75 kg), 750 mg (for body weight between 75 and 100 kg), and 1g (for body weight above 100kg) intravenous infusion on Week 0 (Day 1), Week 2 (Day 15), Week 4 (Day 29) and every 4 weeks (28 days) thereafter up to the end of the study.
703113|NCT01835431|B3|Baseline|Total|Total of all reporting groups
703114|NCT01835431|B2|Baseline|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703115|NCT01835431|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703116|NCT01835431|P2|Participant Flow|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703117|NCT01835431|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703118|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703119|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703120|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703121|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703122|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703123|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703124|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703125|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703126|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703127|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703128|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703129|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703178|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703130|NCT01835431|O2|Outcome|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703131|NCT01835431|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703132|NCT01835431|E2|Reported Event|IDet OD/BID|Insulin detemir (IDet) OD/BID (once daily /twice daily) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 2-4 times daily for 16 weeks
703133|NCT01835431|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) once daily (OD) 2-4U was administered subcutaneously in the thigh, upper arm (deltoid area) or abdomen with the main meal and IAsp was given with the remaining meals 1-3 times daily for 16 weeks.
703134|NCT01835379|B3|Baseline|Total|Total of all reporting groups
703135|NCT01835379|B2|Baseline|Standard|"Standard Care~Standard Care as chosen by the Investigator"
703136|NCT01835379|B1|Baseline|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
703137|NCT01835379|P2|Participant Flow|Standard|"Standard Care~Standard Care as chosen by the Investigator"
703138|NCT01835379|P1|Participant Flow|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
703139|NCT01835379|O2|Outcome|Standard|"Standard Care~Standard Care as chosen by the Investigator"
703140|NCT01835379|O1|Outcome|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
703141|NCT01835379|O2|Outcome|Standard|"Standard Care~Standard Care as chosen by the Investigator"
703142|NCT01835379|O1|Outcome|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
703143|NCT01835379|E2|Reported Event|Standard|"Standard Care~Standard Care as chosen by the Investigator"
703144|NCT01835379|E1|Reported Event|Oasis|"Oasis~Oasis Ultra applied once per week for up to 12 weeks."
703145|NCT01835262|B3|Baseline|Total|Total of all reporting groups
703146|NCT01835262|B2|Baseline|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
703147|NCT01835262|B1|Baseline|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
703148|NCT01835262|P2|Participant Flow|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
703149|NCT01835262|P1|Participant Flow|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
703150|NCT01835262|O2|Outcome|Ketamine Group|"Ketamine Group - - Receiving ketamine at 0.3 mg/given as IVP~Ketamine: Ketamine:0.3 mg/given as IVP"
703151|NCT01835262|O1|Outcome|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
703153|NCT01835262|E1|Reported Event|Morphine|"Morphine Group -- Receiving morphine at 0.1 mg /kg given as IVP~Morphine: Morphine: 0.1 mg /kg given as IVP"
703154|NCT01835132|B1|Baseline|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703155|NCT01835132|P1|Participant Flow|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703156|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703157|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703158|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703159|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703160|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703161|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703162|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703163|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703164|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703165|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703166|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703167|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703168|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703169|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703170|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703171|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703172|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703173|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703174|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703175|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703176|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703177|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703179|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703180|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703181|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703182|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703183|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703184|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703185|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703186|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703187|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703188|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703189|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703190|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703191|NCT01835132|O1|Outcome|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703192|NCT01835132|E1|Reported Event|Gevokizumab|"Subcutaneous injection of 60 mg gevokizumab~Gevokizumab: Subcutaneous injection of 60 mg gevokizumab"
703193|NCT01835015|B6|Baseline|Total|Total of all reporting groups
703194|NCT01835015|B5|Baseline|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703195|NCT01835015|B4|Baseline|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703196|NCT01835015|B3|Baseline|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703197|NCT01835015|B2|Baseline|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703198|NCT01835015|B1|Baseline|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703199|NCT01835015|P5|Participant Flow|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703200|NCT01835015|P4|Participant Flow|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703201|NCT01835015|P3|Participant Flow|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703204|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703205|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703206|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703207|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703208|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703209|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703210|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703211|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703212|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703213|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703214|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703215|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703216|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703217|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703218|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703219|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703220|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703221|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703222|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703223|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703224|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703225|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703226|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703227|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703228|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703229|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703230|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703231|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703232|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703233|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703234|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703235|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703236|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703240|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703241|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703242|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703243|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703244|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703245|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703246|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703247|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703248|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703249|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703250|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703251|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703252|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703253|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703254|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703255|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703256|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703257|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703258|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703259|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703260|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703261|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703262|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703263|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703264|NCT01835015|O5|Outcome|CLG561, Level E|Single 100 μL intravitreal injection of CLG561, Dose Level E
703265|NCT01835015|O4|Outcome|CLG561, Level D|Single 50 μL intravitreal injection of CLG561, Dose Level D
703266|NCT01835015|O3|Outcome|CLG561, Level C|Single 50 μL intravitreal injection of CLG561, Dose Level C
703267|NCT01835015|O2|Outcome|CLG561, Level B|Single 50 μL intravitreal injection of CLG561, Dose Level B
703268|NCT01835015|O1|Outcome|CLG561, Level A|Single 50 μL intravitreal injection of CLG561, Dose Level A
703269|NCT01835015|E6|Reported Event|Pretreatment|Reported prior to the initiation of study treatment
703270|NCT01835015|E5|Reported Event|CLG561, Level E|Reported subsequent to the initiation of treatment
703271|NCT01835015|E4|Reported Event|CLG561, Level D|Reported subsequent to the initiation of treatment
703272|NCT01835015|E3|Reported Event|CLG561, Level C|Reported subsequent to the initiation of treatment
703273|NCT01835015|E2|Reported Event|CLG561, Level B|Reported subsequent to the initiation of treatment
703274|NCT01835015|E1|Reported Event|CLG561, Level A|Reported subsequent to the initiation of treatment
703275|NCT01834404|B3|Baseline|Total|Total of all reporting groups
703276|NCT01834404|B2|Baseline|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703277|NCT01834404|B1|Baseline|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703278|NCT01834404|P2|Participant Flow|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703279|NCT01834404|P1|Participant Flow|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703280|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703281|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703282|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703283|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703284|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703285|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703286|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703448|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703287|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703288|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703289|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703290|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703291|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703292|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703293|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703294|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703295|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703296|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703297|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703298|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703299|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703300|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703301|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703302|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703303|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703304|NCT01834404|O2|Outcome|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703305|NCT01834404|O1|Outcome|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703306|NCT01834404|E2|Reported Event|Placebo|Qualifying participants were assigned to placebo for a minimum of 5 days. Placebo pills matched the study drug in appearance for the 2 dose levels.
703307|NCT01834404|E1|Reported Event|Phentermine-Topiramate ER|Qualifying participants were assigned to the Phentermine-Topiramate ER for a minimum of 5 days. The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
703308|NCT01834274|B3|Baseline|Total|Total of all reporting groups
703309|NCT01834274|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
703310|NCT01834274|B1|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
703311|NCT01834274|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
703312|NCT01834274|P1|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
703313|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
703314|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
703315|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
703316|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
703317|NCT01834274|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
703318|NCT01834274|O1|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
703319|NCT01834274|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, once daily, fasiglifam placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum tolerated dose), tablets, orally, daily for up to 24 weeks.
703320|NCT01834274|E1|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg tablets, orally, once daily, sitagliptin placebo-matching tablets, orally, once daily, and metformin stable dose ≥1500 mg (or maximum-tolerated dose), tablets, orally, daily for up to 24 weeks.
703321|NCT01834261|B3|Baseline|Total|Total of all reporting groups
703322|NCT01834261|B2|Baseline|Placebo, Then Oxytocin|"Healthy adult subjects received several puffs of Syntocinon Placebo Formulation, 40IU, once, prior to MRI and/or MEG scanning.~This group contains subjects who received placebo prior to first scan and oxytocin prior to second scan."
703323|NCT01834261|B1|Baseline|Oxytocin, Then Placebo|"Healthy adult subjects received several puffs of Syntocinon Nasal Spray, 40IU, once, prior to MRI and/or MEG scanning.~This group contains subjects who received oxytocin prior to first scan and placebo prior to second scan."
703324|NCT01834261|P2|Participant Flow|Placebo, Then Oxytocin|Healthy adult subjects who received placebo before their first scan, and oxytocin before their second scan.
703325|NCT01834261|P1|Participant Flow|Oxytocin, Then Placebo|Healthy adult subjects who received oxytocin before their first scan, and placebo before their second scan.
703326|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
703327|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
703328|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
703329|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
703330|NCT01834261|O2|Outcome|Placebo|Subjects received placebo prior to the scan.
703331|NCT01834261|O1|Outcome|Oxytocin|Subjects received oxytocin prior to the scan.
703332|NCT01834261|E2|Reported Event|Placebo, Then Oxytocin|Subjects who received placebo before their first scan, and oxytocin before their second scan.
703333|NCT01834261|E1|Reported Event|Oxytocin, Then Placebo|Subjects who received oxytocin before their first scan, and placebo before their second scan.
703334|NCT01834222|B1|Baseline|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703335|NCT01834222|P1|Participant Flow|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 milliliter (mL) intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703336|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703337|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703338|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703339|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703340|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703341|NCT01834222|O1|Outcome|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703342|NCT01834222|E1|Reported Event|Prevenar 13|Participants received single dose of Prevenar 13 vaccine, 0.5 mL intramuscularly on Day 1. Participants were followed up to 28 days after last dose of study vaccination.
703343|NCT01834027|B3|Baseline|Total|Total of all reporting groups
703344|NCT01834027|B2|Baseline|No Music|"The patients in this group will have noise-cancelling headphones but no music will be played.~No music: In this group, noise-cancelling headphones will be worn, but no music will be played in PACU"
703345|NCT01834027|B1|Baseline|Jazz Music|"Jazz music will be played through noise-cancelling headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
703346|NCT01834027|P2|Participant Flow|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
703347|NCT01834027|P1|Participant Flow|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
703348|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
703397|NCT01833533|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
703349|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
703350|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
703351|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
703352|NCT01834027|O2|Outcome|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
703353|NCT01834027|O1|Outcome|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
703354|NCT01834027|E2|Reported Event|No Music|"The patients in this group with have headphones but no music will be played.~No music: In this group nu music will be played in PACU"
703355|NCT01834027|E1|Reported Event|Jazz Music|"Jazz music will be played through headphones to post-surgical hysterectomy patients while they are in the post anesthesia care unit.~Jazz music: Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit."
703356|NCT01833897|B1|Baseline|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703357|NCT01833897|P1|Participant Flow|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703358|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703510|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703359|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703360|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703361|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703362|NCT01833897|O1|Outcome|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703363|NCT01833897|E1|Reported Event|Ketamine and DCS Treatment|Standard of Care: Subjects will receive treatment with either quetiapine, olanzapine-fluoxetine, or lurasidone. If after about 2 week, subjects are symptomatic, subjects will receive infusion of ketamine hydrochloride (0.5 mg/kg). After the ketamine phase, subject who show improvement will begin an 8-week treatment of oral D-cycloserine.
703364|NCT01833845|B1|Baseline|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
703365|NCT01833845|P1|Participant Flow|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
703398|NCT01833481|B4|Baseline|Total|Total of all reporting groups
703399|NCT01833481|B3|Baseline|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703366|NCT01833845|O1|Outcome|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
703367|NCT01833845|E1|Reported Event|Ribavirin+HCQ|"Administration of RBV monotherapy for a period of 8 weeks following administration of up to 16 weeks combination therapy with ribavirin(RBV) plus Hydroxychloroquine(HCQ).~Ribavirin: weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.~Hydroxychloroquine: subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)"
703368|NCT01833741|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703369|NCT01833741|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703370|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703371|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703372|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703373|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703374|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703375|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703376|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703377|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703378|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703379|NCT01833741|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703380|NCT01833741|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
703381|NCT01833533|B3|Baseline|Total|Total of all reporting groups
703382|NCT01833533|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703383|NCT01833533|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
704036|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
703384|NCT01833533|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703385|NCT01833533|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
703386|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703387|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
703388|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703389|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
703390|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703391|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
703392|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703393|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
703394|NCT01833533|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703395|NCT01833533|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
703396|NCT01833533|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
703704|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
703400|NCT01833481|B2|Baseline|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703401|NCT01833481|B1|Baseline|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703402|NCT01833481|P3|Participant Flow|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703403|NCT01833481|P2|Participant Flow|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703404|NCT01833481|P1|Participant Flow|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703405|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703406|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703429|NCT01833130|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703407|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703408|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703409|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703410|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703411|NCT01833481|O3|Outcome|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703412|NCT01833481|O2|Outcome|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703413|NCT01833481|O1|Outcome|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703414|NCT01833481|E3|Reported Event|THA Using Posterior-lateral Approach|"Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703447|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703415|NCT01833481|E2|Reported Event|THA Using Anterior-lateral Approach|"Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703416|NCT01833481|E1|Reported Event|THA Using Direct-anterior Surgical Approach|"Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.~Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking."
703417|NCT01833403|B1|Baseline|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
703418|NCT01833403|P1|Participant Flow|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
703419|NCT01833403|O1|Outcome|Measurement of Insulin Sensitivity|"All participants will undergo a hyperinsulinemic-euglycemic clamp to measure insulin sensitivity~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery"
703420|NCT01833403|O1|Outcome|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
703421|NCT01833403|E1|Reported Event|Hyperinsulinemic-euglycemic Clamp|"hyperinsulinemic-euglycemic clamp~Hyperinsulinemic-euglycemic clamp: Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery~Glucose"
703422|NCT01833247|B1|Baseline|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
703423|NCT01833247|P1|Participant Flow|Epilepsy Inpatients|Patients who have blood or salivary (or both) levels recorded after a seizure.
703424|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
703425|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
703426|NCT01833247|O1|Outcome|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
703427|NCT01833247|E1|Reported Event|Epilepsy Inpatients|Patients with epilepsy recorded in an inpatient video-EEG monitoring unit after a seizure.
703428|NCT01833130|B3|Baseline|Total|Total of all reporting groups
704037|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
703430|NCT01833130|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703431|NCT01833130|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703432|NCT01833130|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703433|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703434|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703435|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703436|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703437|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703438|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703439|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703440|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703441|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703442|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703443|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703444|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703445|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703446|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703449|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703450|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703451|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703452|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703453|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703454|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703455|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703456|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703457|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703458|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703459|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703460|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703461|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703462|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703463|NCT01833130|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703464|NCT01833130|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703465|NCT01833130|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703466|NCT01833130|E1|Reported Event|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 units (U) total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
703467|NCT01833117|B3|Baseline|Total|Total of all reporting groups
703468|NCT01833117|B2|Baseline|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
703469|NCT01833117|B1|Baseline|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
703470|NCT01833117|P2|Participant Flow|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
703471|NCT01833117|P1|Participant Flow|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
703472|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
703473|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
703474|NCT01833117|O2|Outcome|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
703475|NCT01833117|O1|Outcome|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
703476|NCT01833117|E2|Reported Event|Blink|Blink® Tears, 1 drop instilled in the study eye, single dose
703477|NCT01833117|E1|Reported Event|FID 119515A|FID 119515A, 1 drop instilled in the study eye, single dose
703478|NCT01833078|B1|Baseline|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
703479|NCT01833078|P1|Participant Flow|Ghrelin|All participants received 7.5 mcg/kg of ghrelin as a once daily subcutaneous dose for seven consecutive days. Days 1, 2 and 7 will be in the research center. Days 3,4,5,and 6 will be self administered at home.
703480|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
703481|NCT01833078|O1|Outcome|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
703482|NCT01833078|E1|Reported Event|Ghrelin|ghrelin: ghrelin administration subcutaneously for 7 days
703483|NCT01833065|B4|Baseline|Total|Total of all reporting groups
703484|NCT01833065|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form.
703485|NCT01833065|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form.
703486|NCT01833065|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form.
703487|NCT01833065|P5|Participant Flow|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
703488|NCT01833065|P4|Participant Flow|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
703489|NCT01833065|P3|Participant Flow|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
703490|NCT01833065|P2|Participant Flow|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and received placebo during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
703491|NCT01833065|P1|Participant Flow|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period (i.e. 12 week efficacy assessment) and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period (i.e. 16 week safety assessment).
703492|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703493|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703494|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703495|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703496|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703497|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703498|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703499|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703500|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703501|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703502|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703503|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703504|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703505|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703506|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703507|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703508|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703509|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703511|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703512|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703513|NCT01833065|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703514|NCT01833065|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703515|NCT01833065|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till end of 12-week Treatment Period.
703516|NCT01833065|E5|Reported Event|PLCBO/EBX 10|Patients in this arm received placebo during the 12-week Treatment Period and received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
703517|NCT01833065|E4|Reported Event|EBX 5/PLCBO|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
703518|NCT01833065|E3|Reported Event|EBX 5/EBX 5|Patients in this arm received Elobixibat 5 mg/day during the 12-week Treatment Period and also received Elobixibat 5 mg/day during the 4-week Withdrawal Period.
703519|NCT01833065|E2|Reported Event|EBX 10/PLCBO|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and received placebo during the 4-week Withdrawal Period.
703520|NCT01833065|E1|Reported Event|EBX 10/EBX 10|Patients in this arm received Elobixibat 10 mg/day during the 12-week Treatment Period and also received Elobixibat 10 mg/day during the 4-week Withdrawal Period.
703521|NCT01832766|B1|Baseline|Entire Study Population|includes groups randomized to receive placebo first or dronabinol 10 mg first
703522|NCT01832766|P2|Participant Flow|Placebo First Then 10 mg Dronabinol|identical capsule given orally once in first intervention period then 1 week washout period then dronabinol 10 mg given orally once in second intervention period
703523|NCT01832766|P1|Participant Flow|Dronabinol 10 mg First Then Placebo|dronabinol 10 mg given oral one dose in first intervention period then 1 week washout period and then placebo given oral in one dose in second intervention period
703524|NCT01832766|O2|Outcome|Placebo|identical capsule given once
703525|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
703526|NCT01832766|O2|Outcome|Placebo|identical capsule given once
703527|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
703528|NCT01832766|O2|Outcome|Placebo|identical capsule given once
703529|NCT01832766|O1|Outcome|Dronabinol|dronabinol 10 mg given oral one dose
703530|NCT01832766|E2|Reported Event|Placebo|identical capsule given once
703531|NCT01832766|E1|Reported Event|Dronabinol|dronabinol 10 mg given oral one dose
703532|NCT01832506|B4|Baseline|Total|Total of all reporting groups
703533|NCT01832506|B3|Baseline|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703534|NCT01832506|B2|Baseline|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703705|NCT01831726|E1|Reported Event|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
703535|NCT01832506|B1|Baseline|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703536|NCT01832506|P3|Participant Flow|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703537|NCT01832506|P2|Participant Flow|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703538|NCT01832506|P1|Participant Flow|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 milligram (mg) orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703539|NCT01832506|O1|Outcome|MSC2156119J Combined|All subjects who were administered with MSC2156119J 215 mg, 300mg or 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703540|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703541|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703542|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703543|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703544|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703545|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703546|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703547|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703548|NCT01832506|O1|Outcome|MSC2156119J 200 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703549|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703550|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703551|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703552|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703553|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703554|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703555|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703556|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703557|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703558|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703559|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703560|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703561|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703562|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703563|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703564|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703565|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703566|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703567|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703568|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703569|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703706|NCT01831466|B13|Baseline|Total|Total of all reporting groups
703570|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703571|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703572|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703573|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703574|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703575|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703576|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703577|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703578|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703579|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703580|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703581|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703582|NCT01832506|O3|Outcome|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703583|NCT01832506|O2|Outcome|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703584|NCT01832506|O1|Outcome|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703585|NCT01832506|E3|Reported Event|MSC2156119J 500 mg|Subjects were administered with MSC2156119J 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703586|NCT01832506|E2|Reported Event|MSC2156119J 300 mg|Subjects were administered with MSC2156119J 300 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703587|NCT01832506|E1|Reported Event|MSC2156119J 215 mg|Subjects were administered with MSC2156119J 215 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
703588|NCT01832493|B1|Baseline|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
703589|NCT01832493|P1|Participant Flow|Cardiac Resynchronization Therapy Patients|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
703590|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
703591|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
703592|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
703593|NCT01832493|O1|Outcome|Cardiac Resynchronization Therapy|"Patients implanted with a cardiac resynchronization therapy device~Cardiac Resynchronization Therapy: All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods."
703594|NCT01832493|E1|Reported Event|All Enrolled Patients|Adverse events were collected and are reported for all 50 enrolled patients
703595|NCT01832155|B3|Baseline|Total|Total of all reporting groups
703596|NCT01832155|B2|Baseline|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703597|NCT01832155|B1|Baseline|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
703598|NCT01832155|P2|Participant Flow|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703599|NCT01832155|P1|Participant Flow|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
703707|NCT01831466|B12|Baseline|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
703600|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703601|NCT01832155|O2|Outcome|Yoga Intervention Group|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703602|NCT01832155|O1|Outcome|Wait-list Control Group|Participants in the control group received the same Hatha yoga program at the end of 8 weeks when the intervention group completed their intervention classes.
703603|NCT01832155|O1|Outcome|Both Groups During Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703604|NCT01832155|O1|Outcome|About the Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703605|NCT01832155|O1|Outcome|All Participants|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703606|NCT01832155|O1|Outcome|Class Rentention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703607|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703608|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
704791|NCT01826604|B2|Baseline|Control|Other retractor used during C-section
703609|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703610|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
703611|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703612|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
703613|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703614|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
703615|NCT01832155|O2|Outcome|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703616|NCT01832155|O1|Outcome|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
707189|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
703617|NCT01832155|E2|Reported Event|Yoga Intervention|"The yoga intervention received eight 60 minute weekly Hatha yoga intervention classes and asked to practice additional 30 minute yoga per day at home.~Hatha yoga : Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques."
703618|NCT01832155|E1|Reported Event|Wait List Control|"The wait list control group received the same 8-week Hatha yoga intervention involving group and home-based exercise sessions after the yoga intervention group completed the intervention at the end of 8 weeks.~Hatha Yoga : The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes."
703619|NCT01831934|B3|Baseline|Total|Total of all reporting groups
703620|NCT01831934|B2|Baseline|Control Group|"Fluzone®~Fluzone®"
703621|NCT01831934|B1|Baseline|MELAS Group|"Fluzone®~Fluzone®"
703622|NCT01831934|P2|Participant Flow|Control Group: 18-65 Years of Age|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
703623|NCT01831934|P1|Participant Flow|MELAS Group:13-60 Years of Age.|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: Quadrivalent inactivated influenza vaccine given given intramuscularly in 0.5ml doses."
703624|NCT01831934|O2|Outcome|Control Group|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
703625|NCT01831934|O1|Outcome|MELAS Group|"Fluzone® 2011-2012 Formula~Fluzone® 2011-2012 Formula: This vaccine is given intramuscularly"
703626|NCT01831934|E2|Reported Event|Control Group|"Fluzone®~Fluzone®"
703627|NCT01831934|E1|Reported Event|MELAS Group|"Fluzone®~Fluzone®"
703628|NCT01831817|B5|Baseline|Total|Total of all reporting groups
703629|NCT01831817|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703630|NCT01831817|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703631|NCT01831817|B2|Baseline|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703632|NCT01831817|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703633|NCT01831817|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703634|NCT01831817|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703635|NCT01831817|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703636|NCT01831817|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703637|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703638|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703682|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703639|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703640|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703641|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703642|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703643|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703644|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703645|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703646|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703647|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703648|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703649|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703650|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703651|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703652|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703653|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703654|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703655|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703656|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703657|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703658|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703659|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703660|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703661|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703662|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703663|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703664|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703665|NCT01831817|O4|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703666|NCT01831817|O3|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703667|NCT01831817|O2|Outcome|0% Calcium Sodium Phosphosilicate/Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703668|NCT01831817|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703669|NCT01831817|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
703670|NCT01831817|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
703671|NCT01831817|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703672|NCT01831817|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|DDentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppm fluoride as sodium monofluorophosphate
703673|NCT01831791|B1|Baseline|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703674|NCT01831791|P1|Participant Flow|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703675|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703676|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703677|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703678|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703679|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703680|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703681|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703683|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703684|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703685|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703686|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703687|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703688|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703689|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703690|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703691|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703692|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703693|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703694|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703695|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703696|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703697|NCT01831791|O1|Outcome|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703698|NCT01831791|E1|Reported Event|Dutasteride 0.5 mg|Participants received an Open-Label dutasteride 0.5 milligram (mg) capsule, Once Daily (QD) for 52 weeks.
703699|NCT01831726|B1|Baseline|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
703700|NCT01831726|P1|Participant Flow|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
703701|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
703702|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
703703|NCT01831726|O1|Outcome|TKI258|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
703708|NCT01831466|B11|Baseline|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703709|NCT01831466|B10|Baseline|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703710|NCT01831466|B9|Baseline|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
703711|NCT01831466|B8|Baseline|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703712|NCT01831466|B7|Baseline|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703713|NCT01831466|B6|Baseline|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703714|NCT01831466|B5|Baseline|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703715|NCT01831466|B4|Baseline|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703716|NCT01831466|B3|Baseline|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703717|NCT01831466|B2|Baseline|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703718|NCT01831466|B1|Baseline|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703719|NCT01831466|P12|Participant Flow|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
703720|NCT01831466|P11|Participant Flow|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703721|NCT01831466|P10|Participant Flow|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703722|NCT01831466|P9|Participant Flow|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
703723|NCT01831466|P8|Participant Flow|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703724|NCT01831466|P7|Participant Flow|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703871|NCT01831219|E1|Reported Event|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical sys...
703725|NCT01831466|P6|Participant Flow|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703726|NCT01831466|P5|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703727|NCT01831466|P4|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/g Once Daily (QD)|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703728|NCT01831466|P3|Participant Flow|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703729|NCT01831466|P2|Participant Flow|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703730|NCT01831466|P1|Participant Flow|Mild/Moderate: Tofacitinib 20 mg/Gram (mg/g) Twice Daily (BID)|Participants with a baseline Calculated Physician’s Global Assessment (PGA-C) score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703731|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703732|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703733|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703734|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703735|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703736|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703737|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703738|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703739|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703740|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703741|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703742|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703743|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703744|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703745|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703746|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703747|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703748|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703749|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703750|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703751|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703752|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703753|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703754|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703755|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703756|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703757|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703758|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703759|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703760|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703761|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703762|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703763|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703764|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703765|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703766|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703767|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703768|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703769|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703770|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703771|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703772|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703773|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703774|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703775|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703776|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703777|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703778|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703779|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703780|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703781|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703782|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703783|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703784|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703785|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703786|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703787|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703788|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703789|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703790|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703791|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703792|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703793|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703794|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703795|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703796|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703797|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703798|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703799|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703800|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703801|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703802|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703803|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703804|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703805|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703806|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703807|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703808|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703809|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703810|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703811|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703812|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703813|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703814|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703815|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703816|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703817|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703818|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703819|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703820|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703821|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703822|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703823|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703824|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703825|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703826|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703827|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703828|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703829|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703830|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703831|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703832|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703833|NCT01831466|O6|Outcome|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703834|NCT01831466|O5|Outcome|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703835|NCT01831466|O4|Outcome|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703836|NCT01831466|O3|Outcome|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703837|NCT01831466|O2|Outcome|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703838|NCT01831466|O1|Outcome|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703839|NCT01831466|E12|Reported Event|Severe: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), QD for 12 weeks.
703840|NCT01831466|E11|Reported Event|Severe: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703841|NCT01831466|E10|Reported Event|Severe: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703842|NCT01831466|E9|Reported Event|Severe: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of severe (4) applied placebo ointment (vehicle), BID for 12 weeks.
703843|NCT01831466|E8|Reported Event|Severe: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703844|NCT01831466|E7|Reported Event|Severe: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of severe (4) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703845|NCT01831466|E6|Reported Event|Mild/Moderate: Placebo (Vehicle) QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), QD for 12 weeks.
703846|NCT01831466|E5|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment 10 mg/g, QD for 12 weeks.
703847|NCT01831466|E4|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g QD|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, QD for 12 weeks.
703848|NCT01831466|E3|Reported Event|Mild/Moderate: Placebo (Vehicle) BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied placebo ointment (vehicle), BID for 12 weeks.
703849|NCT01831466|E2|Reported Event|Mild/Moderate: Tofacitinib 10 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 10 mg/g, BID for 12 weeks.
703850|NCT01831466|E1|Reported Event|Mild/Moderate: Tofacitinib 20 mg/g BID|Participants with a baseline PGA-C score of mild (2) or moderate (3) applied tofacitinib ointment, 20 mg/g, BID for 12 weeks.
703851|NCT01831219|B3|Baseline|Total|Total of all reporting groups
703852|NCT01831219|B2|Baseline|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703853|NCT01831219|B1|Baseline|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703854|NCT01831219|P2|Participant Flow|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703855|NCT01831219|P1|Participant Flow|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703856|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703857|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703858|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703859|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703860|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703861|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703862|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703863|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703864|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703865|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703866|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703867|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703868|NCT01831219|O2|Outcome|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703869|NCT01831219|O1|Outcome|ROBODOC|The ROBODOC group received total hip arthroplasty using the ROBODOC Surgical system for preparation of the femoral canal for a femoral stem implant.
703870|NCT01831219|E2|Reported Event|Conventional|The conventional group received total hip arthroplasty using the conventional manual tools including a broach to prepare the femoral cavity for femoral stem replacement.
703872|NCT01831154|B4|Baseline|Total|Total of all reporting groups
703873|NCT01831154|B3|Baseline|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703874|NCT01831154|B2|Baseline|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703875|NCT01831154|B1|Baseline|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703876|NCT01831154|P3|Participant Flow|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703902|NCT01830933|B1|Baseline|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
703936|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703937|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
707190|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
703877|NCT01831154|P2|Participant Flow|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703878|NCT01831154|P1|Participant Flow|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703879|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703880|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703897|NCT01831154|E3|Reported Event|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703881|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703882|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703883|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703903|NCT01830933|P2|Participant Flow|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
703904|NCT01830933|P1|Participant Flow|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
703884|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703885|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703886|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703887|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703888|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703916|NCT01830920|B5|Baseline|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703917|NCT01830920|B4|Baseline|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703918|NCT01830920|B3|Baseline|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
704038|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
703889|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703890|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703891|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703892|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703893|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703894|NCT01831154|O3|Outcome|Standard Glycemic Group|"The standard glycemic group received intravenous injections of regular insulin in the intraoperative period titrated per the usual care protocol utilized at the study site. The initial bolus of insulin was initiated prior to induction of anesthesia if the morning blood glucose is greater than 180 mg/dl or any time intraoperatively that the blood glucose rises above 180 mg/dl. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Standard Glycemic: Insulin was Regular Insulin administered intravenous bolus."
703895|NCT01831154|O2|Outcome|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703896|NCT01831154|O1|Outcome|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703919|NCT01830920|B2|Baseline|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703920|NCT01830920|B1|Baseline|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
704039|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
703898|NCT01831154|E2|Reported Event|Conventional Glycemic Group|"The conventional glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial insulin bolus and infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 180 mg/dl or any time intraoperatively that the blood glucose elevated above 180 mg/dl. The insulin infusion was titrated throughout the intraoperative period to maintain blood glucose levels between 150-180 mg/dl.The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes. Upon transfer to the ICU the intraoperative protocol ended and all subjects received the standardized glycemic control for the ICU.~Conventional Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703899|NCT01831154|E1|Reported Event|Tight Glycemic Group|"The tight glycemic group received a continuous intravenous infusion of regular insulin in the intraoperative period titrated per a modified Portland Protocol from Vanderbilt University Medical Center, Tennessee. The initial bolus of insulin and insulin infusion was initiated prior to induction of anesthesia if the morning blood glucose was greater than 149 mg/dl or any time intraoperatively the blood glucose elevated above 149 mg/dl.The titration of insulin for the tight glycemic group maintained blood glucose levels between 110-149 mg/dl throughout the intraoperative period. The intraoperative blood glucose was titrated to blood glucose levels sampled every 30 minutes.Upon transfer to the intensive care unit the protocol ended and all subjects received the same glycemic control.~Tight Glycemic: The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline."
703900|NCT01830933|B3|Baseline|Total|Total of all reporting groups
703901|NCT01830933|B2|Baseline|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
703905|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
703906|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
703907|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
703908|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
703909|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
703910|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
703911|NCT01830933|O2|Outcome|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
703912|NCT01830933|O1|Outcome|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
703913|NCT01830933|E2|Reported Event|BreastCARE Intervention|"Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.~Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patients before she meets with her doctor.~BreastCARE : The physician will receive a physician report that contains information similar to the patient report."
703914|NCT01830933|E1|Reported Event|Usual Care|Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care.
703915|NCT01830920|B6|Baseline|Total|Total of all reporting groups
704034|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
703921|NCT01830920|P5|Participant Flow|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703922|NCT01830920|P4|Participant Flow|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703923|NCT01830920|P3|Participant Flow|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703924|NCT01830920|P2|Participant Flow|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703925|NCT01830920|P1|Participant Flow|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
703926|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703927|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703928|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703929|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703930|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
703931|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703932|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703933|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703934|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703935|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
704067|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
703938|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703939|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703940|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
703941|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703942|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703943|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703944|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703945|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
703946|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703947|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703948|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703949|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703950|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
703951|NCT01830920|O5|Outcome|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703952|NCT01830920|O4|Outcome|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703953|NCT01830920|O3|Outcome|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
704035|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
703954|NCT01830920|O2|Outcome|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703955|NCT01830920|O1|Outcome|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
703956|NCT01830920|E5|Reported Event|THR-184 Dose 4|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses ~80% of the pre-surgery dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703957|NCT01830920|E4|Reported Event|THR-184 Dose 3|"THR-184 initial pre-surgery high dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703958|NCT01830920|E3|Reported Event|THR-184 Dose 2|"THR-184 initial pre-surgery mid-dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703959|NCT01830920|E2|Reported Event|THR-184 Dose 1|"THR-184 initial pre-surgery low dose followed by (3) post surgery doses at the low dose.~THR-184: THR-184 is a synthetic oligopeptide administered intravenously."
703960|NCT01830920|E1|Reported Event|Placebo|"An identical appearing placebo will be administered.~Placebo: A normal saline solution identical in appearance to the active drug solution"
703961|NCT01830881|B3|Baseline|Total|Total of all reporting groups
703962|NCT01830881|B2|Baseline|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703963|NCT01830881|B1|Baseline|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703964|NCT01830881|P2|Participant Flow|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703965|NCT01830881|P1|Participant Flow|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703966|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703967|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703968|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703969|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703970|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703971|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703972|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703973|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703974|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703975|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703976|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703977|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703978|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703979|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703980|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703981|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703982|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703983|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703984|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703985|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703986|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703987|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703988|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703989|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703990|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703991|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703992|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703993|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703994|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703995|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703996|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703997|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703998|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
703999|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
704000|NCT01830881|O2|Outcome|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
704001|NCT01830881|O1|Outcome|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
704002|NCT01830881|E2|Reported Event|Midazolam and Ibuprofen|"5 mL oral midazolam oral syrup (2 mg/mL) and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Midazolam: 5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
704003|NCT01830881|E1|Reported Event|Placebo-cherry Syrup and Ibuprofen|"5 mL oral placebo-cherry syrup and 800 mg oral ibuprofen 30-60 minutes prior to procedure 20 mL injection 1% lidocaine without epinephrine~Ibuprofen: 800 mg oral ibuprofen 30-60 minutes prior to procedure~Placebo-Cherry syrup: 5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure~Lidocaine: injection of 20 mL 1% lidocaine without epinephrine"
704004|NCT01830855|B5|Baseline|Total|Total of all reporting groups
704005|NCT01830855|B4|Baseline|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704006|NCT01830855|B3|Baseline|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704007|NCT01830855|B2|Baseline|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704008|NCT01830855|B1|Baseline|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704009|NCT01830855|P4|Participant Flow|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704010|NCT01830855|P3|Participant Flow|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704011|NCT01830855|P2|Participant Flow|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704012|NCT01830855|P1|Participant Flow|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704013|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704014|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704015|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704016|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704017|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704018|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704019|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704020|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704021|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704022|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule.
704023|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule.
704024|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704025|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704026|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704027|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704028|NCT01830855|O2|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704029|NCT01830855|O1|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704030|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704031|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704032|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704033|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704040|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704041|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704042|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704043|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704044|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704045|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704046|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704047|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704048|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704049|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704050|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704051|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704052|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704053|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704054|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704055|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704056|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704057|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704058|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704059|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704060|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704061|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704062|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704063|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704064|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704065|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704066|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704068|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704069|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704070|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704071|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704072|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704073|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704074|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704075|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704076|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704077|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704078|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704079|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704080|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704081|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704082|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704083|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704084|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704085|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704086|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704087|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704088|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704089|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704090|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704091|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704092|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704093|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704094|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704095|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704096|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704097|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704098|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704099|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704100|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704101|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704102|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704103|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704104|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704105|NCT01830855|O2|Outcome|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704106|NCT01830855|O1|Outcome|rLP2086 (Lots 1-3)|Commercial lots 1, 2 and 3 on a 0-, 2-, 6-months schedule.
704107|NCT01830855|O3|Outcome|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704108|NCT01830855|O2|Outcome|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704109|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704110|NCT01830855|O1|Outcome|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704111|NCT01830855|E4|Reported Event|Group 4 HAV/Saline|Hepatitis A virus vaccine (HAV) on a 0- and 6-month schedule and saline at Month 2.
704112|NCT01830855|E3|Reported Event|Group 3 rLP2086 Lot 3|Lot 3 on a 0-, 2-, 6- month schedule
704113|NCT01830855|E2|Reported Event|Group 2 rLP2086 Lot 2|Lot 2 on a 0-, 2-, 6- month schedule
704114|NCT01830855|E1|Reported Event|Group 1 rLP2086 Lot 1|Lot 1 on a 0-, 2-, 6- month schedule.
704115|NCT01830790|B3|Baseline|Total|Total of all reporting groups
704116|NCT01830790|B2|Baseline|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704117|NCT01830790|B1|Baseline|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704118|NCT01830790|P2|Participant Flow|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704119|NCT01830790|P1|Participant Flow|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704120|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704121|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704122|NCT01830790|O2|Outcome|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704123|NCT01830790|O1|Outcome|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704124|NCT01830790|E2|Reported Event|AMD Patients|"Age-related macular degeneration (AMD) patients >65 years old without other ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704125|NCT01830790|E1|Reported Event|Healthy Controls|"Healthy individuals >65 years old without ocular disease, who will be given a single dose of 100mg sildenafil citrate, then imaged with EDI-OCT to determine a change in choroidal thickness~Sildenafil citrate: Single dose of 100mg Sildenafil citrate"
704126|NCT01830699|B3|Baseline|Total|Total of all reporting groups
704127|NCT01830699|B2|Baseline|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
704128|NCT01830699|B1|Baseline|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
704129|NCT01830699|P2|Participant Flow|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
704130|NCT01830699|P1|Participant Flow|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
704131|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
704515|NCT01827462|B2|Baseline|60-79 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone®~This vaccine is given intramuscularly"
704132|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
704133|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
704134|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
704135|NCT01830699|O2|Outcome|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
704136|NCT01830699|O1|Outcome|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
704137|NCT01830699|E2|Reported Event|Rilonacept|"160 mg of rilonacept will be injected in the subacromial bursa of participants in this arm.~Rilonacept: 160 mg intra-bursal once"
704138|NCT01830699|E1|Reported Event|Triamcinolone (Kenalog)|"A mixture of lidocaine without epinephrine, bupivicaine, and 80 mg of triamcinolone acetonide will be injected in the subacromial bursa.~Corticosteroid (Triamcinolone (Kenalog) )"
704139|NCT01830205|B5|Baseline|Total|Total of all reporting groups
704140|NCT01830205|B4|Baseline|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704141|NCT01830205|B3|Baseline|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704142|NCT01830205|B2|Baseline|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704143|NCT01830205|B1|Baseline|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704379|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
704144|NCT01830205|P4|Participant Flow|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704145|NCT01830205|P3|Participant Flow|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704146|NCT01830205|P2|Participant Flow|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704147|NCT01830205|P1|Participant Flow|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had estimated glomerular filtration rate (eGFR) 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704148|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704149|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704187|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704242|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704150|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704151|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704152|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704153|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704154|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704155|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704156|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704157|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704158|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704159|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704160|NCT01830205|O4|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704161|NCT01830205|O3|Outcome|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704162|NCT01830205|O2|Outcome|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704188|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704163|NCT01830205|O1|Outcome|Normal Renal Function/Mild Renal Impairment|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704164|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704165|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704166|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
704167|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were re-randomized from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704168|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704169|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704170|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704171|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704172|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704173|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704284|NCT01829477|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704174|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704175|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704176|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704177|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704178|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704179|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704180|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704181|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704182|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704183|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704184|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704185|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704186|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704347|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
704189|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704190|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704191|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704192|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704193|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704194|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704195|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704196|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704197|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704198|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704199|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704200|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704201|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704202|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704203|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704204|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704205|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
704206|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704207|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704208|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704209|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704210|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704211|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
704212|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704213|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
704348|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
704214|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704215|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1
704216|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704217|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704218|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704219|NCT01830205|O5|Outcome|End Stage Renal Disease|Participants with end stage renal disease and had estimated glomerular filtration rate (eGFR) < 15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704220|NCT01830205|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704221|NCT01830205|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704222|NCT01830205|O2|Outcome|Mild Renal Impairment|Participants were reallocated from other arms (normal, moderate and severe renal impairment) with mild renal impairment who had eGFR 60-89 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704223|NCT01830205|O1|Outcome|Normal Renal Function|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >= 90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704224|NCT01830205|E4|Reported Event|End Stage Renal Disease|Participants with end stage renal disease and had eGFR <15 mL/ min per 1.73 m^2, with or without hemodialysis were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1.
704254|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704225|NCT01830205|E3|Reported Event|Mild/Severe Renal Impairment|Participants with severe renal impairment and had eGFR 15 to 29 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704226|NCT01830205|E2|Reported Event|Mild/Moderate Renal Impairment|Participants with moderate renal impairment and had eGFR 30-59 mL/min per 1.73 m^2 were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Two participants from this group, who had eGFR 60-89 mL/min per 1.73 m^2, were reallocated into mild renal impairment reporting arm and were administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704227|NCT01830205|E1|Reported Event|Group-A|Participants with normal renal function and had creatinine clearance by the Cockcroft-Gault method >=90 milliliter per minute were administered with single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. One participant from this group, who had eGFR 60-89 mL/min per 1.73 m^2, was reallocated into mild renal impairment reporting arm and was administered with a single oral dose of daclatasvir 60 mg tablet after 10 hours of overnight fasting on Day 1. Original allocation was based on an estimated eGFR, while the reallocation was based on the eGFR measurement at baseline.
704228|NCT01830140|B3|Baseline|Total|Total of all reporting groups
704229|NCT01830140|B2|Baseline|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
704230|NCT01830140|B1|Baseline|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
704231|NCT01830140|P2|Participant Flow|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
704232|NCT01830140|P1|Participant Flow|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
704233|NCT01830140|O2|Outcome|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
704234|NCT01830140|O1|Outcome|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
704235|NCT01830140|E2|Reported Event|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
704236|NCT01830140|E1|Reported Event|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
704237|NCT01830127|B3|Baseline|Total|Total of all reporting groups
704238|NCT01830127|B2|Baseline|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704239|NCT01830127|B1|Baseline|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704240|NCT01830127|P2|Participant Flow|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704241|NCT01830127|P1|Participant Flow|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704243|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704244|NCT01830127|O2|Outcome|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704245|NCT01830127|O1|Outcome|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704246|NCT01830127|E2|Reported Event|Arm2: Child-Pugh B|Arm 2 (genotype 1b) - 400mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704247|NCT01830127|E1|Reported Event|Arm1: Child-Pugh A|Arm 1 (genotype 1b) - 600mg DBV tablet taken orally twice daily (BID) plus 120mg FDV capsule taken orally once daily (QD) plus RBV tablet taken orally twice daily for 24 weeks.
704248|NCT01829919|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704249|NCT01829919|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704250|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704251|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704252|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704253|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704283|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704255|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704256|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704257|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704258|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704259|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704260|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704261|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704262|NCT01829919|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules 7.5 mg|"Brisdelle (paroxetine mesylate) Capsules 7.5 mg~All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704263|NCT01829919|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Brisdelle (paroxetine mesylate) Capsules~All subjects will receive Brisdelle (paroxetine mesylate) capsules, first as a single dose and then, following a five-day wash-out period, once per day for 14 days."
704264|NCT01829516|B1|Baseline|All Study Participants|This is a crossover study of 39 moderate to heavy social alcohol users who will receive a single dose 40 IU of intranasal oxytocin followed by 40 IU of placebo or vice versa.
704265|NCT01829516|P2|Participant Flow|Placebo First Then Oxytocin|"14 moderate to heavy social alcohol users received a single dose 40 IU of intranasal placebo followed by a single dose 40 IU of intranasal oxytocin.~NOTE: This is a cross-over design and subjects will participate in both arms."
704266|NCT01829516|P1|Participant Flow|Oxytocin First, Then Placebo|"18 moderate to heavy social alcohol users received a single dose 40 IU of intranasal oxytocin followed by a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms."
704267|NCT01829516|O2|Outcome|Placebo|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
704349|NCT01829191|E1|Reported Event|All Subjects|All subjects who eligible to participate in the study whether or not randomized to the study arm.
704268|NCT01829516|O1|Outcome|Oxytocin|In this crossover study, 18 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin followed by a single dose of 40 IU of intranasal placebo and 14 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin, for a total of 32 completed participants.
704269|NCT01829516|O2|Outcome|Placebo|14 moderate to heavy social alcohol users received 40 IU of intranasal placebo followed by 40 IU of intranasal oxytocin and 18 received 40 IU of intranasal oxytocin first followed by 40 IU of intranasal placebo, for a total of 32 participants analyzed.
704270|NCT01829516|O1|Outcome|Oxytocin|18 moderate to heavy social alcohol users received 40 IU of intranasal oxytocin followed by 40 IU of intranasal placebo and 14 received 40 IU of intranasal placebo first followed by 40 IU of intranasal oxytocin, for a total of 32 participants analyzed.
704271|NCT01829516|E2|Reported Event|Placebo|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal placebo.~NOTE: This is a cross-over design and subjects will participate in both arms.~Placebo"
704272|NCT01829516|E1|Reported Event|Oxytocin|"50 moderate to heavy social alcohol users will receive a single dose 40 IU of intranasal oxytocin.~Oxytocin"
704273|NCT01829477|B3|Baseline|Total|Total of all reporting groups
704274|NCT01829477|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704275|NCT01829477|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704276|NCT01829477|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704277|NCT01829477|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704278|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704279|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704280|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704281|NCT01829477|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704282|NCT01829477|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704285|NCT01829477|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily and glimepiride 6 mg (or maximum tolerated dose), tablet, orally, once daily for up to 24 weeks.
704286|NCT01829464|B4|Baseline|Total|Total of all reporting groups
704287|NCT01829464|B3|Baseline|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704288|NCT01829464|B2|Baseline|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704289|NCT01829464|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
704290|NCT01829464|P3|Participant Flow|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704291|NCT01829464|P2|Participant Flow|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704292|NCT01829464|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
704293|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704294|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704295|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
704296|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704297|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704298|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
704299|NCT01829464|O3|Outcome|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704350|NCT01828593|B4|Baseline|Total|Total of all reporting groups
704300|NCT01829464|O2|Outcome|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704301|NCT01829464|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
704302|NCT01829464|E3|Reported Event|Fasiglifam 50 mg QD|Fasiglifam 50 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704303|NCT01829464|E2|Reported Event|Fasiglifam 25 mg QD|Fasiglifam 25 mg, tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin >=1500 mg, tablets, orally, once daily for up to 24 weeks.
704304|NCT01829464|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily and sitagliptin 100 mg, tablets, orally, once daily with or without metformin greater than or equal to (>=) 1500 mg, tablets, orally, once daily for up to 24 weeks.
704305|NCT01829399|B3|Baseline|Total|Total of all reporting groups
704306|NCT01829399|B2|Baseline|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
704307|NCT01829399|B1|Baseline|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|On the first visit, subcutaneous axillary ring of 10 to 15 ml of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation. On the second visit, a subcutaneous axillary ring of 10 to 15 ml of saline was injected 15 minutes prior to tourniquet inflation.
704308|NCT01829399|P2|Participant Flow|Saline Ring 1st Visit, Bupivacaine Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with normal saline on the first visit and a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the second visit.
704309|NCT01829399|P1|Participant Flow|Bupivacaine Ring 1st Visit, Saline Ring 2nd Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000 on the first visit and a subcutaneous axillary ring injection with saline on the second visit.
704310|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of normal saline was injected 15 minutes prior to tourniquet inflation.
704311|NCT01829399|O1|Outcome|Bupivacaine Ring 1st Visit|On the first visit, a subcutaneous axillary ring of 10 to 15 mL of 0.25% Bupivacaine with epinephrine 1:200,000 was injected 15 minutes prior to tourniquet inflation.
704312|NCT01829399|O2|Outcome|Saline Axillary Ring on 1st Visit (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline.
704313|NCT01829399|O1|Outcome|Bupivacaine Axillary Ring on 1st Visit|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000.
704314|NCT01829399|E2|Reported Event|Saline Axillary Ring (Control Group)|Participants received a subcutaneous axillary ring injection with normal saline
704315|NCT01829399|E1|Reported Event|Bupivacaine Axillary Ring|Participants received a subcutaneous axillary ring injection with 0.25% Bupivacaine with epinephrine 1:200.000
704316|NCT01829243|B1|Baseline|Subjects Who Completed the Study|
704317|NCT01829243|P2|Participant Flow|Placebo First, Then Milnacipran|Patients randomized to receive placebo first
704318|NCT01829243|P1|Participant Flow|Milnacipran First, Then Placebo|Patients randomized to receiving milnacipran first.
704319|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
704320|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking the Milnacipran.
704321|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
704322|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran
704323|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
704324|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
704325|NCT01829243|O2|Outcome|Placebo|Data is summarize for all patients while they were taking the placebo.
704326|NCT01829243|O1|Outcome|Milnacipran|Data is summarize for all patients while they were taking Milnacipran.
704327|NCT01829243|E2|Reported Event|Placebo|Adverse events in this group occurred while subjects were taking Placebo.
704328|NCT01829243|E1|Reported Event|Milnacipran|Adverse events in this group occurred while subjects were taking Milnacipran.
704329|NCT01829230|B3|Baseline|Total|Total of all reporting groups
704330|NCT01829230|B2|Baseline|Test Lens A|Test lens A from previous study
704331|NCT01829230|B1|Baseline|Test Lens C|Test lens C from previous study
704332|NCT01829230|P2|Participant Flow|Test Lens A|Test lens A from previous study
704333|NCT01829230|P1|Participant Flow|Test Lens C|Test lens C from previous study
704334|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
704335|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
704336|NCT01829230|O2|Outcome|Test Lens A|Test lens A from the previous study
704337|NCT01829230|O1|Outcome|Test Lens C|Test lens C from the previous study
704338|NCT01829230|E2|Reported Event|Test Lens A|Test lens A from previous study
704339|NCT01829230|E1|Reported Event|Test Lens C|Test lens C from previous study
704340|NCT01829191|B3|Baseline|Total|Total of all reporting groups
704341|NCT01829191|B2|Baseline|Test Lens C|Test lens will be worn in a daily wear modality
704342|NCT01829191|B1|Baseline|Test Lens A|Test lenses will be worn in a daily wear modality
704343|NCT01829191|P2|Participant Flow|Test Lens C|Test lens will be worn in a daily wear modality
704344|NCT01829191|P1|Participant Flow|Test Lens A|Test lenses will be worn in a daily wear modality
704345|NCT01829191|O2|Outcome|Test Lens C|Test lenses will be worn in a daily wear modality
704346|NCT01829191|O1|Outcome|Test Lens A|Test lenses will be worn in a daily wear modality
704351|NCT01828593|B3|Baseline|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704352|NCT01828593|B2|Baseline|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704353|NCT01828593|B1|Baseline|Placebo|Matching Placebo
704354|NCT01828593|P3|Participant Flow|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704355|NCT01828593|P2|Participant Flow|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704356|NCT01828593|P1|Participant Flow|Placebo|"Matching Placebo~Following 4 weeks in placebo-controlled phase were randomized to either SBI 2.5 g or SBI 5.0 g"
704357|NCT01828593|O3|Outcome|SBI 5.0 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 5.0 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704358|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 grams~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704359|NCT01828593|O1|Outcome|Placebo|Matching Placebo
704360|NCT01828593|O3|Outcome|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704361|NCT01828593|O2|Outcome|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704362|NCT01828593|O1|Outcome|Placebo|Matching Placebo
704363|NCT01828593|E2|Reported Event|SBI 5.0g|"Serum-derived bovine immunoglobulin protein isolate (SBI)5.0g - Subjects on 5.0 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 5.0 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704364|NCT01828593|E1|Reported Event|SBI 2.5 g|"Serum-derived bovine immunoglobulin protein isolate (SBI) 2.5 g - Subjects on 2.5 g in the placebo controlled phase and placebo free phase and subjects who went from placebo in the placebo controlled phase to 2.5 g in the placebo free phase~Serum-derived bovine immunoglobulin protein isolate (SBI): SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients."
704365|NCT01828476|B3|Baseline|Total|Total of all reporting groups
704366|NCT01828476|B2|Baseline|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
704388|NCT01828281|B3|Baseline|Total|Total of all reporting groups
704389|NCT01828281|B2|Baseline|Control|subtherapeutic CPAP using 4 cm water
704516|NCT01827462|B1|Baseline|18-30 Years Old at Enrollment|"Participants receive the licensed annual, Fluzone®~This vaccine is given intramuscularly"
704367|NCT01828476|B1|Baseline|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
704368|NCT01828476|P2|Participant Flow|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
704369|NCT01828476|P1|Participant Flow|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
704370|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
704371|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
704372|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
704373|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
704374|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
704375|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
704376|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
704377|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
704378|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
704380|NCT01828476|O2|Outcome|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
704381|NCT01828476|O1|Outcome|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
704382|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
704383|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
704384|NCT01828476|O2|Outcome|ARM B|"Abiraterone with both ABT-263 and Hydroxychloroquine~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B~Hydroxychloroquine: ARM B"
704385|NCT01828476|O1|Outcome|ARM A|"Abiraterone with ABT-263~Abiraterone: ARM A and ARM B~ABT-263: ARM A and ARM B"
704386|NCT01828476|E2|Reported Event|ARM B - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily, ABT-263 150 mg po daily, Hydroxychloroquine 200 mg po BID daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily*, Hydroxychloroquine 400 mg po BID daily Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 325 mg po daily*, Hydroxychloroquine 400 mg po BID daily~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3."
704387|NCT01828476|E1|Reported Event|ARM A - Dose Escalation|"Dose level 0: Abiraterone 1000 mg po daily and ABT-263 150 mg po daily Dose level 1: Abiraterone 1000 mg po daily and ABT-263 250 mg po daily* Dose level 2 (maximum planned phase II dose): Abiraterone 1000 mg po daily and ABT-263 350 mg po daily*~* All patients at the 250 mg/day and 325 mg/day doses will start at 150 mg/day for the first 7 days (on Day -7) and escalated to their respective full dose on Day 1 if no DLT is observed and platelets are >50,000/mm3.~NOTE: The dose escalation for ABT-263 combined with abiraterone was completed first prior to dose escalation with ABT-263 combined with hydroxychloroquine and abiraterone. Following both dose escalation portions of the trial, patients will then, and only then, be assigned to Arm A or Arm B of the phase II portion of the trial on a rotating basis of every other patient."
704390|NCT01828281|B1|Baseline|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
704391|NCT01828281|P2|Participant Flow|Control|subtherapeutic CPAP using 4 cm water
704392|NCT01828281|P1|Participant Flow|Therapeutic CPAP|The continuous positive airway pressure (CPAP) level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
704393|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
704394|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
704395|NCT01828281|O2|Outcome|Control|subtherapeutic CPAP using 4 cm water
704396|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
704397|NCT01828281|O2|Outcome|Control|"subtherapeutic CPAP using 4 cm water~CPAP: All subjects will undergo ultrasound examination of the abdomen the day after overnight PSG and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water."
704398|NCT01828281|O1|Outcome|Therapeutic CPAP|The CPAP level for each patient in the arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
704399|NCT01828281|E2|Reported Event|Control|subtherapeutic CPAP using 4 cm water
704400|NCT01828281|E1|Reported Event|Therapeutic CPAP|The CPAP level for each patient in the therapeutic CPAP arm was set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night, as determined by the overnight CPAP titration study.
704401|NCT01828216|B3|Baseline|Total|Total of all reporting groups
704402|NCT01828216|B2|Baseline|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
704403|NCT01828216|B1|Baseline|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
704404|NCT01828216|P2|Participant Flow|Ambulatory Sleep Study|The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
704405|NCT01828216|P1|Participant Flow|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
704406|NCT01828216|O2|Outcome|Ambulatory Sleep Study|Home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
704407|NCT01828216|O1|Outcome|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
704408|NCT01828216|O2|Outcome|Ambulatory CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
704409|NCT01828216|O1|Outcome|In-hospital CPAP Titration|Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
704410|NCT01828216|E2|Reported Event|Ambulatory Sleep Study|home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events.
704411|NCT01828216|E1|Reported Event|In-hospital Sleep Study|Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry.
704412|NCT01828164|B1|Baseline|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
704413|NCT01828164|P1|Participant Flow|All Study Participants|As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
704444|NCT01827670|B3|Baseline|Total|Total of all reporting groups
704414|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
704415|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side of the mouth received treatment while the other side of the mouth served as the control. In this design, each subject was both treated and served as control.
704416|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
704417|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
704418|NCT01828164|O2|Outcome|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
704419|NCT01828164|O1|Outcome|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
704420|NCT01828164|E2|Reported Event|Control Arm|The side of the mouth that was the control. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
704421|NCT01828164|E1|Reported Event|Treatment Arm|The side of the mouth that received treatment. As per split mouth design, one side received treatment while the other side served as the control. In this design, each subject was both treated and served as control.
704422|NCT01827839|B1|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704423|NCT01827839|P1|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704424|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704425|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704426|NCT01827839|O3|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704427|NCT01827839|O2|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704428|NCT01827839|O1|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704429|NCT01827839|O3|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704430|NCT01827839|O2|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704431|NCT01827839|O1|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704432|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704433|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704434|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704435|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704436|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704437|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704438|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704439|NCT01827839|O4|Outcome|GSK1437173A Group >=70 YOA|Subgroup of subjects of or above 70 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704440|NCT01827839|O3|Outcome|GSK1437173A Group 60-69 YOA|Subgroup of subjects between 60 and 69 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704441|NCT01827839|O2|Outcome|GSK1437173A Group 50-59 YOA|Subgroup of subjects between 50 and 59 Years of Age (YOA) who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704442|NCT01827839|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly (IM) in the deltoid of the non-dominant arm.
704443|NCT01827839|E1|Reported Event|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 2-month schedule, administered intramuscularly into the deltoid muscle of the non-dominant arm.
704445|NCT01827670|B2|Baseline|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
704446|NCT01827670|B1|Baseline|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
704447|NCT01827670|P2|Participant Flow|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
704448|NCT01827670|P1|Participant Flow|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds .
704449|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
704450|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
704451|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
704452|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
704453|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride Dentifrice)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454% w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
704454|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 mililiter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
704455|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
704456|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
704457|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds
704458|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
704459|NCT01827670|O2|Outcome|Test Dentrifice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
704460|NCT01827670|O1|Outcome|Control Dentrifice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds.
704461|NCT01827670|E2|Reported Event|Test Dentifrice (0.454% Stannous Fluoride)|Participants dosed the toothbrush with at least a 1-inch strip of the test dentifrice (0.454 % w/w Stannous Fluoride) and brushed whole mouth for one timed minute, ensuring they brushed all sensitive areas of their teeth. Participants were permitted to rinse after each brushing with 5 mL potable water (kept at room temperature) for a maximum 5 timed seconds.
704792|NCT01826604|B1|Baseline|Alexis O C-section Retractor|Alexis O retractor used during C-section
704462|NCT01827670|E1|Reported Event|Control Dentifrice (0.76% Sodium Monofluorophosphate)|Participants dosed the toothbrush with at least a 1-inch strip of the control dentifrice [0.76% weight for weight (w/w) Sodium Monofluorophosphate] and brushed whole mouth for one timed minute. Participants were permitted to rinse after each brushing with 5 milliliter (mL) potable water (kept at room temperature) for a maximum 5 timed seconds
704463|NCT01827592|B4|Baseline|Total|Total of all reporting groups
704464|NCT01827592|B3|Baseline|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704465|NCT01827592|B2|Baseline|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704466|NCT01827592|B1|Baseline|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704467|NCT01827592|P3|Participant Flow|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704468|NCT01827592|P2|Participant Flow|EBX 5|Elobixibat 5 mg/day as administered orally in a tablet form starting from Baseline visit till EoT visit.
704469|NCT01827592|P1|Participant Flow|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till End of the Treatment (EoT) visit.
704470|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704471|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704472|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704473|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704474|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704475|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704476|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704477|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704478|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704479|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704480|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704481|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704482|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704483|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704484|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704485|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704486|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704487|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704488|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704489|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704490|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704491|NCT01827592|O3|Outcome|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704492|NCT01827592|O2|Outcome|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704493|NCT01827592|O1|Outcome|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704494|NCT01827592|E3|Reported Event|PLCBO|Placebo was administered orally in a tablet form starting from Baseline visit till EoT visit.
704495|NCT01827592|E2|Reported Event|EBX 5|Elobixibat 5 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704496|NCT01827592|E1|Reported Event|EBX 10|Elobixibat 10 mg/day was administered orally in a tablet form starting from Baseline visit till EoT visit.
704497|NCT01827475|B4|Baseline|Total|Total of all reporting groups
704498|NCT01827475|B3|Baseline|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
704499|NCT01827475|B2|Baseline|Acetaminophen|Acetaminophen 1 gm
704500|NCT01827475|B1|Baseline|Ibuprofen|Ibuprofen 800 mg
704501|NCT01827475|P3|Participant Flow|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
704502|NCT01827475|P2|Participant Flow|Acetaminophen|Acetaminophen 1 gm
704503|NCT01827475|P1|Participant Flow|Ibuprofen|Ibuprofen 800 mg
704504|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
704505|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
704506|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
704507|NCT01827475|O3|Outcome|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
704508|NCT01827475|O2|Outcome|Acetaminophen|Acetaminophen 1 gm
704509|NCT01827475|O1|Outcome|Ibuprofen|Ibuprofen 800 mg
704510|NCT01827475|E3|Reported Event|Ibuprofen-acetaminophen Combination|Ibuprofen 800 mg plus acetaminophen 1 gm
704511|NCT01827475|E2|Reported Event|Acetaminophen|Acetaminophen 1 gm
704512|NCT01827475|E1|Reported Event|Ibuprofen|Ibuprofen 800 mg
704513|NCT01827462|B4|Baseline|Total|Total of all reporting groups
704514|NCT01827462|B3|Baseline|80-100 Years Old at Enrollment|"Participants receive the licensed annual vaccine, Fluzone® or High Dose Fluzone®~This vaccine is given intramuscularly"
704517|NCT01827462|P3|Participant Flow|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
704518|NCT01827462|P2|Participant Flow|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
704519|NCT01827462|P1|Participant Flow|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
704520|NCT01827462|O3|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.~This vaccine is given intramuscularly"
704521|NCT01827462|O2|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season. For the following seasons, they received Fluzone High-Dose.~This vaccine is given intramuscularly"
704522|NCT01827462|O1|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through 2013-2014 then received licensed annual quadrivalent Fluzone.~This vaccine is given intramuscularly"
704523|NCT01827462|O3|Outcome|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
704524|NCT01827462|O2|Outcome|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
704525|NCT01827462|O1|Outcome|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone®~This vaccine is given intramuscularly"
704526|NCT01827462|E3|Reported Event|80-100 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.~This vaccine is given intramuscularly"
704527|NCT01827462|E2|Reported Event|60-79 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed High-Dose trivalent inactivated vaccine, Fluzone High-Dose, starting with the 2014-2015 season.~This vaccine is given intramuscularly"
704528|NCT01827462|E1|Reported Event|18-30 Years Old at Enrollment|"Participants receive the licensed annual trivalent vaccine, Fluzone® through the 2013-2014 season then they received licensed quadrivalent vaccine, Fluzone starting with the 2014-2015 season.~This vaccine is given intramuscularly"
704529|NCT01827371|B5|Baseline|Total|Total of all reporting groups
704530|NCT01827371|B4|Baseline|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
704531|NCT01827371|B3|Baseline|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
704532|NCT01827371|B2|Baseline|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
704533|NCT01827371|B1|Baseline|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
704534|NCT01827371|P4|Participant Flow|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
704535|NCT01827371|P3|Participant Flow|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
704536|NCT01827371|P2|Participant Flow|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
704537|NCT01827371|P1|Participant Flow|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
704538|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
704539|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
704540|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
704541|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
704542|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
704543|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
704544|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
704545|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
704546|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
704547|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
704548|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
704549|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
704550|NCT01827371|O4|Outcome|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
704551|NCT01827371|O3|Outcome|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
704552|NCT01827371|O2|Outcome|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
704553|NCT01827371|O1|Outcome|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
704554|NCT01827371|E4|Reported Event|Arm D: IMVAMUNE Days 1+29, Stratis|IMVAMUNE® 1x10^8 TCID50/0.5 mL subcutaneously (SC) via Stratis™ auto injector on Days 1 and 29.
704555|NCT01827371|E3|Reported Event|Arm C: IMVAMUNE Days 1+22, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 22.
704556|NCT01827371|E2|Reported Event|Arm B: IMVAMUNE Days 1+15, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL SC) via syringe and needle on Days 1 and 15.
704557|NCT01827371|E1|Reported Event|Arm A: IMVAMUNE Days 1+29, Syringe and Needle|IMVAMUNE 1x10^8 TCID50/0.5 mL subcutaneously (SC) via syringe and needle on Days 1 and 29.
704558|NCT01827332|B3|Baseline|Total|Total of all reporting groups
704559|NCT01827332|B2|Baseline|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
704560|NCT01827332|B1|Baseline|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET."
704561|NCT01827332|P2|Participant Flow|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
704562|NCT01827332|P1|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
704563|NCT01827332|O2|Outcome|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
704564|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
704565|NCT01827332|O2|Outcome|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
704566|NCT01827332|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
704567|NCT01827332|E2|Reported Event|Saline|"intranasal administration~Saline: Subjects will be administered 40 IUs of saline nasal spray (placebo) prior to two individual sessions of MET."
704568|NCT01827332|E1|Reported Event|Oxytocin|"intranasal administration~Oxytocin: Subjects will be administered 40 IUs of oxytocin nasal spray prior to two individual sessions of MET."
704569|NCT01827319|B1|Baseline|Received TMR and Enrolled in ANGINA RELIEF Registry|
704570|NCT01827319|P1|Participant Flow|Received TMR and Enrolled in ANGINA RELIEF Registry|
704571|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
704572|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
704573|NCT01827319|O1|Outcome|Received TMR and Enrolled in ANGINA RELIEF Registry|
704574|NCT01827319|E1|Reported Event|Received TMR and Enrolled in ANGINA RELIEF Registry|
704575|NCT01827306|B3|Baseline|Total|Total of all reporting groups
704576|NCT01827306|B2|Baseline|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
704577|NCT01827306|B1|Baseline|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
704578|NCT01827306|P2|Participant Flow|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
704579|NCT01827306|P1|Participant Flow|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
704580|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
704581|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
704582|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
704583|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
704584|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
704585|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
704586|NCT01827306|O2|Outcome|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
704587|NCT01827306|O1|Outcome|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
704588|NCT01827306|E2|Reported Event|Control|Subjects in this arm will complete a shoulder therapy program as normal, with no intervention.
704589|NCT01827306|E1|Reported Event|Biofreeze|"Apply 5 minutes before therapy by applying a small coin sized amount to the painful area. Subjects will then complete a standard shoulder therapy program.~Biofreeze"
704590|NCT01827254|B1|Baseline|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
704591|NCT01827254|P1|Participant Flow|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
704592|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by third line treatment with bevacizumab (with interferon), bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
704672|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704593|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib, followed by second line treatment with bevacizumab (with interferon),bevacizumab (without interferon), sorafenib, axitinib, temsirolimus or everolimus as per standard local practice.
704594|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­interventional study.
704595|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
704596|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non­-interventional study.
704597|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first­line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon,bevacizumab without interferon, sorafenib,axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-­interventional study.
704598|NCT01827254|O1|Outcome|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with metastatic renal cell carcinoma (MRCC) who met the selection criteria and received sunitinib as first-line therapy as per standard local practice.
704599|NCT01827254|E1|Reported Event|Metastatic Renal Cell Carcinoma (mRCC) Cohort|Participants diagnosed with mRCC who met the selection criteria and received first-line sunitinib as per standard local practice, followed by one or more lines of different treatments (bevacizumab with interferon, bevacizumab without interferon, sorafenib, axitinib, temsirolimus or everolimus), and, lastly were rechallenged with sunitinib between 2006 and May 2013 were included in this non-interventional study.
704600|NCT01826981|B16|Baseline|Total|Total of all reporting groups
704601|NCT01826981|B15|Baseline|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704602|NCT01826981|B14|Baseline|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704740|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704603|NCT01826981|B13|Baseline|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704604|NCT01826981|B12|Baseline|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704605|NCT01826981|B11|Baseline|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704606|NCT01826981|B10|Baseline|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704607|NCT01826981|B9|Baseline|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704608|NCT01826981|B8|Baseline|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704609|NCT01826981|B7|Baseline|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704610|NCT01826981|B6|Baseline|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704611|NCT01826981|B5|Baseline|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704612|NCT01826981|B4|Baseline|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704613|NCT01826981|B3|Baseline|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704614|NCT01826981|B2|Baseline|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704615|NCT01826981|B1|Baseline|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704616|NCT01826981|P15|Participant Flow|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704617|NCT01826981|P14|Participant Flow|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704618|NCT01826981|P13|Participant Flow|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704619|NCT01826981|P12|Participant Flow|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704620|NCT01826981|P11|Participant Flow|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704621|NCT01826981|P10|Participant Flow|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|Sofosbuvir (SOF) 400 mg once daily+Velpatasvir (VEL) 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704622|NCT01826981|P9|Participant Flow|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and Child Pugh-Turcotte (CPT) B cirrhosis
704623|NCT01826981|P8|Participant Flow|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704624|NCT01826981|P7|Participant Flow|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704625|NCT01826981|P6|Participant Flow|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704626|NCT01826981|P5|Participant Flow|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704627|NCT01826981|P4|Participant Flow|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704628|NCT01826981|P3|Participant Flow|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704629|NCT01826981|P2|Participant Flow|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
705017|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
704630|NCT01826981|P1|Participant Flow|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704631|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704632|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704633|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704634|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704635|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704636|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704637|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704638|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704639|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704640|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704641|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704642|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704643|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704825|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704644|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704645|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704646|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704647|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704648|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704649|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704650|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704651|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704652|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704653|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704654|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704655|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704656|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704657|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704658|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704659|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704660|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704661|NCT01826981|O1|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704662|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704663|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704664|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704665|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704666|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704667|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704668|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704669|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704670|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704671|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704673|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704674|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704675|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704676|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704677|NCT01826981|O1|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704678|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704679|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704680|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704681|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704682|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704683|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704684|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704685|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
705018|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
704686|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704687|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704688|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704689|NCT01826981|O11|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704690|NCT01826981|O10|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704691|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704692|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704693|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704694|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704695|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704696|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704697|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704698|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704754|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704699|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704700|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704701|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704702|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704703|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704704|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704705|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704706|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704707|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704708|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704709|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704710|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704711|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704739|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704712|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704713|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704714|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704715|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704716|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704717|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704718|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704719|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704720|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704721|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704722|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704723|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704724|NCT01826981|O6|Outcome|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704725|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704726|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704949|NCT01824602|B1|Baseline|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
704727|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704728|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704729|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704730|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704731|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704732|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704733|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704734|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704735|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704736|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704737|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704738|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704741|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704742|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704743|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704744|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704745|NCT01826981|O15|Outcome|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704746|NCT01826981|O14|Outcome|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704747|NCT01826981|O13|Outcome|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704748|NCT01826981|O12|Outcome|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704749|NCT01826981|O11|Outcome|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704750|NCT01826981|O10|Outcome|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704751|NCT01826981|O9|Outcome|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704752|NCT01826981|O8|Outcome|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704753|NCT01826981|O7|Outcome|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704755|NCT01826981|O5|Outcome|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704756|NCT01826981|O4|Outcome|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704757|NCT01826981|O3|Outcome|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704758|NCT01826981|O2|Outcome|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704759|NCT01826981|O1|Outcome|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704760|NCT01826981|E15|Reported Event|Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily + weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704761|NCT01826981|E14|Reported Event|Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 100 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704762|NCT01826981|E13|Reported Event|Cohort 4,Group 2: SOF+VEL 25mg+RBV 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily +VEL 25 mg once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704763|NCT01826981|E12|Reported Event|Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN Noncirrhotic)|SOF 400 mg once daily+VEL 25 mg once daily for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
704764|NCT01826981|E11|Reported Event|Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HCV and HBV Coinfection)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
704765|NCT01826981|E10|Reported Event|Cohort 5,Group 1: LDV/SOF+RBV 24 wk (GT1/3 SOF Retreatment)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 24 weeks in participants with genotype 1 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704766|NCT01826981|E9|Reported Event|Cohort 3,Group 1: LDV/SOF 12 wk (GT1 Cirrhotic CPT B)|LDV/SOF (90/400 mg) once daily for 12 weeks in participants with genotype 1 HCV infection and CPT B cirrhosis
704767|NCT01826981|E8|Reported Event|Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
704768|NCT01826981|E7|Reported Event|Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
704769|NCT01826981|E6|Reported Event|Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 3 HCV infection
704770|NCT01826981|E5|Reported Event|Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)|LDV/SOF (90/400 mg) once daily for 12 weeks in treatment-naive (TN) participants with genotype 3 HCV infection
704771|NCT01826981|E4|Reported Event|Cohort 2,Group 2: LDV/SOF+GS-9669 12 wk (GT1 TE, Liver Disease|LDV/SOF (90/400 mg) once daily + GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704772|NCT01826981|E3|Reported Event|Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, Liver Disease)|LDV/SOF (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
704773|NCT01826981|E2|Reported Event|Cohort 1,Group 2: SOF+Peg+RBV 12 wk (GT2,3 SOF Retreatment)|SOF 400 mg once daily+ pegylated interferon (PEG-IFN) 180 µg once weekly+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
704774|NCT01826981|E1|Reported Event|Cohort 1,Group 1: LDV/SOF+RBV 12 wk (GT1 SOF Retreatment)|Ledipasvir/sofosbuvir (LDV/SOF) (90/400 mg) once daily+weight-based RBV (1000-1200 mg in a divided daily dose) for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study.
704775|NCT01826812|B3|Baseline|Total|Total of all reporting groups
704776|NCT01826812|B2|Baseline|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
704777|NCT01826812|B1|Baseline|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
704778|NCT01826812|P2|Participant Flow|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
704779|NCT01826812|P1|Participant Flow|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
704780|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
704781|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
704782|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
704783|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
704784|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
704785|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
704786|NCT01826812|O2|Outcome|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
704787|NCT01826812|O1|Outcome|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
704788|NCT01826812|E2|Reported Event|Controls|Controls defined as OSDI 12 and less AND total OSS score less than 3
704789|NCT01826812|E1|Reported Event|Dry Eye|Dry eye defined as OSDI score more than 12 and/or total OSS score 3 and more
704790|NCT01826604|B3|Baseline|Total|Total of all reporting groups
704793|NCT01826604|P2|Participant Flow|Control|"Conventional hand-held surgical retractors used for C-sections will be used, including the bladder blade (Doyen retractor) and the Richardson retractor.~Control- Conventional hand-held retractors: Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used."
704794|NCT01826604|P1|Participant Flow|Alexis O C-section Retractor|"The Alexis O C-section retractor will be used. Other hand-held retractors will be used as deemed necessary by the surgeon.~Alexis O C-Section Retractor: The Alexis O C-section retractor will be used. Other hand-held retractors that are deemed necessary to the surgery by the physician will also be used."
704795|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
704796|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
704797|NCT01826604|O2|Outcome|Control|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
704798|NCT01826604|O1|Outcome|Alexis Retractor|Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
704799|NCT01826604|E2|Reported Event|Control|No adverse events
704800|NCT01826604|E1|Reported Event|Alexis Retractor|No adverse events
704801|NCT01826513|B4|Baseline|Total|Total of all reporting groups
704802|NCT01826513|B3|Baseline|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night
704803|NCT01826513|B2|Baseline|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
704804|NCT01826513|B1|Baseline|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
704805|NCT01826513|P3|Participant Flow|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
704806|NCT01826513|P2|Participant Flow|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
704807|NCT01826513|P1|Participant Flow|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
704808|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704809|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704810|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704811|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704812|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704813|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704814|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704815|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704816|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704817|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704818|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704819|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704820|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704821|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704822|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704823|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704824|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
705335|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
704826|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704827|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704828|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704829|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704830|NCT01826513|O2|Outcome|Modified AutoSet Algorithm|Participants completed 1 night receiving therapy with the Modified AutoSet algorithm.
704831|NCT01826513|O1|Outcome|Standard AutoSet Algorithm|Participants completed 1 night receiving therapy with the Standard AutoSet algorithm.
704832|NCT01826513|E3|Reported Event|Modified AutoSet Then Standard AutoSet|Participants first received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) for one night, and then received therapy with the standard AutoSet algorithm the following night.
704833|NCT01826513|E2|Reported Event|Standard AutoSet Algorithm|Participants first received therapy with the Standard AutoSet algorithm for one night, and then received therapy with the Modified AutoSet algorithm (an AutoSet device with an algorithm developed for sleep breathing parameters specific to females) the following night.
704834|NCT01826513|E1|Reported Event|Unblinded Investigational Arm|Participants participated in an unblinded investigational phase of the trial prior to, and separate from, the single-blind cross-over phase of the trial. Data was collected from the his phase to aid the final development of the algorithm before proceeding to algorithm validation (ie. cross-over phase).
704835|NCT01826370|B1|Baseline|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
704836|NCT01826370|P1|Participant Flow|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
704837|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
704838|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
704839|NCT01826370|O1|Outcome|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
704840|NCT01826370|E1|Reported Event|Linagliptin|Linagliptin 5 mg was administered orally once a day for 24 weeks
704841|NCT01826214|B3|Baseline|Total|Total of all reporting groups
704842|NCT01826214|B2|Baseline|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704843|NCT01826214|B1|Baseline|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
705019|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
704844|NCT01826214|P2|Participant Flow|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704845|NCT01826214|P1|Participant Flow|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704846|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704847|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704848|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704849|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704850|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704851|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704852|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704853|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704854|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704855|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704856|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
705429|NCT01822301|O1|Outcome|CT Imaging at 7-21 Days PO|CT imaging at 7-21 days post-operation
704857|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704858|NCT01826214|O2|Outcome|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704859|NCT01826214|O1|Outcome|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704860|NCT01826214|E2|Reported Event|LDE225-800|Patients who were randomized to Schedule B, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704861|NCT01826214|E1|Reported Event|LDE225-400|Patients who were randomized to Schedule A, and received 400 mg LDE225 twice daily for the first two weeks only and after two weeks, received 800 mg LDE225 once daily until disease progression, toxicity, withdrawal of consent, death, discretion of the investigator or early termination of the study.
704862|NCT01826201|B1|Baseline|10% MOL4239 Ointment & Placebo Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
704863|NCT01826201|P1|Participant Flow|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
704864|NCT01826201|O1|Outcome|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
704865|NCT01826201|O2|Outcome|Placebo Ointment|10% MOL4239 to one target lesion and placebo to contralateral target lesion
704866|NCT01826201|O1|Outcome|10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
704867|NCT01826201|E1|Reported Event|0% and 10% MOL4239 Ointment|10% MOL4239 ointment to one target lesion and placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
704868|NCT01825837|B5|Baseline|Total|Total of all reporting groups
704869|NCT01825837|B4|Baseline|ESL (Part I - Not Randomised Patients)|This group corresponds to the 17 patients who did not complete part I and therefore where not randomised to any traeatment group.
704870|NCT01825837|B3|Baseline|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704871|NCT01825837|B2|Baseline|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704872|NCT01825837|B1|Baseline|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704873|NCT01825837|P4|Participant Flow|ESL (Part I)|In Part I, all participants received open-label treatment with BIA 2-093 900 mg once daily for 2 weeks. The participants that completed part I were randomised in Part II.
704874|NCT01825837|P3|Participant Flow|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704875|NCT01825837|P2|Participant Flow|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704876|NCT01825837|P1|Participant Flow|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704877|NCT01825837|O3|Outcome|BIA 2-093 1800 mg|PART II - Intent-to-Treat Population
704878|NCT01825837|O2|Outcome|BIA 2-093 900 mg|PART II - Intent-to-Treat Population
704879|NCT01825837|O1|Outcome|BIA 2-093 300 mg|PART II - Intent-to-Treat Population
704880|NCT01825837|E3|Reported Event|Group 1 [(Part II) 1800 mg]|BIA 2-093 1800 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704881|NCT01825837|E2|Reported Event|Group 2 [(Part II) 900 mg]|BIA 2-093 900 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704882|NCT01825837|E1|Reported Event|Group 3 [(Part II) 300 mg]|BIA 2-093 300 mg once daily (Part II followed a double-blind, parallel-group design in which participants were randomly assigned to treatment with BIA 2-093 300 mg, 900 mg, or 1800 mg once daily). Study medication was administered orally, once daily in the evening.
704883|NCT01825577|B1|Baseline|Single Arm|"Age 65yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
704884|NCT01825577|P1|Participant Flow|Single Arm Transdermal Methylphenidate|"Age 65 yrs and above~Ability to ambulate (may use walking aid)~Male or Female~Clinical diagnosis of probable Alzheimer's Disease~AES score >40~Identified as fall risk by nursing staff"
704950|NCT01824602|P4|Participant Flow|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
705430|NCT01822301|O4|Outcome|Facial Volume Score at 9 Months PO|facial volume score at 3 months post-operation
704885|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.~Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
704886|NCT01825577|O1|Outcome|Transdermal Methylphenidate|"2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.~Transdermal Methylphenidate: 2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day."
704887|NCT01825577|E1|Reported Event|Single Arm Transdermal Methylphenidate|There were no adverse events reported.
704888|NCT01825408|B5|Baseline|Total|Total of all reporting groups
704889|NCT01825408|B4|Baseline|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704890|NCT01825408|B3|Baseline|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704891|NCT01825408|B2|Baseline|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704919|NCT01825200|E1|Reported Event|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
704892|NCT01825408|B1|Baseline|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704893|NCT01825408|P4|Participant Flow|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704894|NCT01825408|P3|Participant Flow|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704895|NCT01825408|P2|Participant Flow|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704896|NCT01825408|P1|Participant Flow|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704897|NCT01825408|O2|Outcome|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704912|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
705672|NCT01820559|E1|Reported Event|Placebo|"Placebo tablets~Placebo : Tablets"
704898|NCT01825408|O1|Outcome|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704899|NCT01825408|O2|Outcome|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704900|NCT01825408|O1|Outcome|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704901|NCT01825408|E4|Reported Event|Azithromycin, 6 Weeks|"Subjects with chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 6 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704920|NCT01825122|B3|Baseline|Total|Total of all reporting groups
704921|NCT01825122|B2|Baseline|Active, Nadolol|"Active~Nadolol"
704922|NCT01825122|B1|Baseline|Placebo|"placebo~Placebo"
704923|NCT01825122|P2|Participant Flow|Active, Nadolol|"Active~Nadolol"
704902|NCT01825408|E3|Reported Event|Azithromycin, 3 Weeks|"Subjects with Chronic Rhinosinusitis without Nasal Polyps will receive Azithromycin 250mg daily, or if allergic to azithromycin, then Augmentin 875mg BID for 3 weeks duration.~Azithromycin: Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704903|NCT01825408|E2|Reported Event|Doxycycline, 6 Weeks|"Subjects with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 6 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704904|NCT01825408|E1|Reported Event|Doxycycline, 3 Weeks|"Subjects with chronic rhinosinusitis with nasal polyps (CRSwNP) will receive Doxycycline 100mg BID or if allergic to doxycycline, then Augmentin 875mg BID for 3 weeks duration. These patients will also receive a course of Prednisone (30mg x 3d, 20mg x 3d, 10mg x3d, 10mg every other day for 6 days (3 doses)) which is standard of care treatment for patients with chronic sinusitis with nasal polyps.~Doxycycline: Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.~Augmentin: If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration"
704905|NCT01825200|B3|Baseline|Total|Total of all reporting groups
704906|NCT01825200|B2|Baseline|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
704907|NCT01825200|B1|Baseline|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
704908|NCT01825200|P2|Participant Flow|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
704909|NCT01825200|P1|Participant Flow|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
704910|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
704911|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
704948|NCT01824602|B2|Baseline|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
704913|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
704914|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
704915|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
704916|NCT01825200|O2|Outcome|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
704917|NCT01825200|O1|Outcome|Flublok|"Flublok containing 3x45µg (135µg total) of rHA0 derived from influenza A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Flublok: A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions."
704918|NCT01825200|E2|Reported Event|Afluria|"Afluria, containing 3x15µg (45µg total), of trivalent, inactivated influenza vaccine (licensed IIV) containing influenza antigen derived from A/H1N1 and A/H3N2 and influenza B viruses in a total volume of 0.5mL~Afluria: Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs."
704924|NCT01825122|P1|Participant Flow|Placebo|"placebo~Placebo"
704929|NCT01824901|B1|Baseline|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
704930|NCT01824901|P4|Participant Flow|Phase II Step II|"Patients receive FGFR inhibitor AZD4547 PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~AZD4547: Given PO"
704931|NCT01824901|P3|Participant Flow|Arm II (Docetaxel and AZD4547; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 1-14. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
704932|NCT01824901|P2|Participant Flow|Arm I (Docetaxel; Phase II Step I)|"Patients receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who experience progressive disease may then register to step II treatment and receive FGFR inhibitor AZD4547 PO BID on days 1-14.~docetaxel: Given IV"
704933|NCT01824901|P1|Participant Flow|Phase I|"Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~AZD4547: Given PO"
704934|NCT01824901|O1|Outcome|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
704935|NCT01824901|E1|Reported Event|Phase I|Patients receive docetaxel IV over 60 minutes on day 1 and FGFR inhibitor AZD4547 PO BID on days 2-15 of course 1 and days 1-14 of all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
704936|NCT01824823|B3|Baseline|Total|Total of all reporting groups
704937|NCT01824823|B2|Baseline|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
704938|NCT01824823|B1|Baseline|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
704939|NCT01824823|P2|Participant Flow|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
704940|NCT01824823|P1|Participant Flow|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
704941|NCT01824823|O2|Outcome|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
704942|NCT01824823|O1|Outcome|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
704943|NCT01824823|E2|Reported Event|Arm B (Placebo)|Patients receive placebo PO QD on days 1-28.
704944|NCT01824823|E1|Reported Event|Arm A (Afatinib)|Patients receive afatinib PO QD on days 1-28.
704945|NCT01824602|B5|Baseline|Total|Total of all reporting groups
704946|NCT01824602|B4|Baseline|Group 1: Eslicarbazepine Acetate 1800 mg|"Eslicarbazepine acetate 1800 mg~Eslicarbazepine acetate 1800 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
704947|NCT01824602|B3|Baseline|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
705673|NCT01820416|B4|Baseline|Total|Total of all reporting groups
704951|NCT01824602|P3|Participant Flow|Group 2: Eslicarbazepine Acetate 1200 mg|"Eslicarbazepine acetate 1200 mg~Eslicarbazepine acetate 1200 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
704952|NCT01824602|P2|Participant Flow|Group 3: Eslicarbazepine Acetate 600 mg|"Eslicarbazepine acetate 600 mg~Eslicarbazepine acetate 600 mg : Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets."
704953|NCT01824602|P1|Participant Flow|Group 4: Placebo|"Placebo pills~Placebo : Placebo sugar pills"
704954|NCT01824602|O4|Outcome|ESL 1800 mg|(ITT Population
704955|NCT01824602|O3|Outcome|ESL 1200 mg|ITT Population
704956|NCT01824602|O2|Outcome|ESL 600 mg|ITT Population
704957|NCT01824602|O1|Outcome|Placebo|ITT Population
704958|NCT01824602|E4|Reported Event|ESL 1800 mg|Safety Population
704959|NCT01824602|E3|Reported Event|ESL 1200 mg|Safety Population
704960|NCT01824602|E2|Reported Event|ESL 600 mg|Safety Population
704961|NCT01824602|E1|Reported Event|Placebo|Safety Population
704962|NCT01824589|B5|Baseline|Total|Total of all reporting groups
704963|NCT01824589|B4|Baseline|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704964|NCT01824589|B3|Baseline|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704965|NCT01824589|B2|Baseline|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704966|NCT01824589|B1|Baseline|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704981|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
705020|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
704967|NCT01824589|P4|Participant Flow|Group D|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704968|NCT01824589|P3|Participant Flow|Group C|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -12cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -7cm H2O ITPR for 15 minutes, then 6ml/kg with -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704969|NCT01824589|P2|Participant Flow|Group B|"no device (washout) with tidal volume setting of 8ml/kg for 20 minutes, then 8ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume decreased to 6ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 6ml/kg for 20 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 8ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704970|NCT01824589|P1|Participant Flow|Group A|"no device (washout) with tidal volume setting of 6ml/kg for 20 minutes, then 6ml/kg with the -7cm H2O ITPR as first device for 15 minutes, then tidal volume increased to 8ml/kg with the -7cm H2O ITPR for 15 minutes, then no device with 8ml/kg for 20 minutes, then 8ml/kg with -12cm H2O ITPR for 15 minutes, then 6ml/kg with -12cm H2O ITPR for 15 minutes, then no device with 6ml/kg.~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704971|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704972|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704973|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704992|NCT01824498|B6|Baseline|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
706300|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
704974|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704975|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704976|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704977|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704978|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704979|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704980|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704982|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704983|NCT01824589|O4|Outcome|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704984|NCT01824589|O3|Outcome|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704985|NCT01824589|O2|Outcome|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704986|NCT01824589|O1|Outcome|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704987|NCT01824589|E4|Reported Event|Group D|"tidal volume setting of 8ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704988|NCT01824589|E3|Reported Event|Group C|"tidal volume setting of 6ml/kg with the -12cm H2O ITPR as first device~-12cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations."
704989|NCT01824589|E2|Reported Event|Group B|"tidal volume setting of 8ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704990|NCT01824589|E1|Reported Event|Group A|"tidal volume setting of 6ml/kg with the -7cm H2O ITPR as first device~-7 cm H2O ITPR: Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations."
704991|NCT01824498|B7|Baseline|Total|Total of all reporting groups
706301|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
704993|NCT01824498|B5|Baseline|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
704994|NCT01824498|B4|Baseline|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
704995|NCT01824498|B3|Baseline|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
704996|NCT01824498|B2|Baseline|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
704997|NCT01824498|B1|Baseline|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
704998|NCT01824498|P6|Participant Flow|Low Fat High Omega 3, Low Fat, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
704999|NCT01824498|P5|Participant Flow|Low Fat High Omega 3, High Fat, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
705000|NCT01824498|P4|Participant Flow|High Fat, Low Fat High Omega 3, Low Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
705001|NCT01824498|P3|Participant Flow|High Fat, Low Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
705002|NCT01824498|P2|Participant Flow|Low Fat, Low Fat High Omega 3, High Fat|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
705003|NCT01824498|P1|Participant Flow|Low Fat, High Fat, Low Fat High Omega 3|Low Fat = 20% fat High Fat = 40% fat Low Fat, high n3 diet = 20% fat + 3% n3
705004|NCT01824498|O3|Outcome|Low Fat, High n3 Diet|Low fat, n3 diet = 20% fat + 3% n3
705005|NCT01824498|O2|Outcome|Low Fat Diet|Low fat diet = 20% fat
705006|NCT01824498|O1|Outcome|High Fat Diet|Hig fat diet = 40% fat
705007|NCT01824498|E3|Reported Event|Low Fat, High n3 Diet|Low fat, high n3 diet = 20% fat + 3% n3
705008|NCT01824498|E2|Reported Event|Low Fat Diet|Low fat diet = 20% fat
705009|NCT01824498|E1|Reported Event|High Fat Diet|High fat diet = 40% fat
705010|NCT01824446|B1|Baseline|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705011|NCT01824446|P1|Participant Flow|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705012|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705013|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705014|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705015|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705016|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705021|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705022|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705023|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705024|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705025|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705026|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705027|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705028|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705029|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705030|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705031|NCT01824446|O1|Outcome|[14C]SSP-004184|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
705032|NCT01824446|E1|Reported Event|[14C]SSP-004184|
705033|NCT01824355|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705034|NCT01824355|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705035|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705062|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705063|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705036|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705037|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705038|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705039|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705040|NCT01824355|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705041|NCT01824355|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:~At least 60% of subjects were younger than 65 years of age.~At least 20% had type 1 diabetes.~At least 50% with type 2 diabetes were insulin users.~Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method."
705042|NCT01824342|B3|Baseline|Total|Total of all reporting groups
705043|NCT01824342|B2|Baseline|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705044|NCT01824342|B1|Baseline|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705120|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
705045|NCT01824342|P2|Participant Flow|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705046|NCT01824342|P1|Participant Flow|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705047|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705048|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705049|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705050|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705051|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705052|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705053|NCT01824342|O2|Outcome|Denosumab/Denosumab|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705054|NCT01824342|O1|Outcome|Placebo/Denosumab|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705055|NCT01824342|E2|Reported Event|Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705056|NCT01824342|E1|Reported Event|Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the parent study received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks (Q4W) for up to 3 years.
705057|NCT01824303|B3|Baseline|Total|Total of all reporting groups
705058|NCT01824303|B2|Baseline|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705059|NCT01824303|B1|Baseline|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705060|NCT01824303|P2|Participant Flow|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705061|NCT01824303|P1|Participant Flow|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705097|NCT01823653|P1|Participant Flow|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
705064|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705065|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705066|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705067|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705068|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705069|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705070|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705071|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705072|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705073|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705074|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705075|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705076|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705077|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705078|NCT01824303|O2|Outcome|LiRIS Placebo|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days.
705079|NCT01824303|O1|Outcome|LiRIS 400 mg|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days.
705080|NCT01824303|E4|Reported Event|LiRIS Placebo/LiRIS 400 mg _Open Label Extension|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
705081|NCT01824303|E3|Reported Event|LiRIS 400 mg_Open Label Extension|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study then LiRIS 400 mg in the Open Label Extension.
705082|NCT01824303|E2|Reported Event|LiRIS Placebo_Randomized Study|LiRIS Placebo: investigational drug-delivery system which contains Lactose and no Lidocaine; the system remains in the bladder for 14 days in the randomized study.
705083|NCT01824303|E1|Reported Event|LiRIS 400 mg_Randomized Study|LiRIS 400 mg: investigational drug-delivery system which contains Lidocaine; the system remains in the bladder for 14 days in the randomized study.
705084|NCT01824160|B1|Baseline|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
705085|NCT01824160|P1|Participant Flow|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
705086|NCT01824160|O1|Outcome|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
705087|NCT01824160|E1|Reported Event|Repair of RV-PA Conduit Disruption|"Covered stenting of RV-PA conduit injury~Repair of RV-PA Conduit Disruption: Repair of RV-PA Conduit Disruption"
705088|NCT01823679|B1|Baseline|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
705089|NCT01823679|P1|Participant Flow|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
705090|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
705091|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
705092|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
705093|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m2|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
705094|NCT01823679|O1|Outcome|Capecitabine 1000 mg/m²|"Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.~Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given orally (PO)"
705095|NCT01823679|E1|Reported Event|Capecitabine 1000 mg/m²|Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
705096|NCT01823653|B1|Baseline|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
705098|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
705099|NCT01823653|O1|Outcome|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
705100|NCT01823653|O1|Outcome|Treated Thigh|Subjects randomly received treatment of either the left or right thigh with the Liposonix System (Model 2)
705101|NCT01823653|O2|Outcome|Control Thigh|Each subject's own thigh untreated during study
705102|NCT01823653|O1|Outcome|Treated Thigh|Randomly assigned left or right thigh that received treatment with Liposonix System (Model 2)
705103|NCT01823653|E1|Reported Event|Treated Thigh|Randomly chosen left or right thigh treated with the Liposonix System (Model 2)
705104|NCT01823614|B7|Baseline|Total|Total of all reporting groups
705105|NCT01823614|B6|Baseline|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
705106|NCT01823614|B5|Baseline|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
705107|NCT01823614|B4|Baseline|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
705108|NCT01823614|B3|Baseline|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
705109|NCT01823614|B2|Baseline|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
705110|NCT01823614|B1|Baseline|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
705111|NCT01823614|P6|Participant Flow|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
705112|NCT01823614|P5|Participant Flow|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
705113|NCT01823614|P4|Participant Flow|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
705114|NCT01823614|P3|Participant Flow|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
705115|NCT01823614|P2|Participant Flow|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
705116|NCT01823614|P1|Participant Flow|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
705117|NCT01823614|O3|Outcome|CD4 Cell Count < 350|Group which contains naive patients with CD4 nadir less than 350 cell/mkl at the moment of enrollment
705118|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains naive patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
705119|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains naive patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
705121|NCT01823614|O2|Outcome|CD4 Cell Count 350-500|Group which contains patients with CD4 nadir between 350 and 500 cell/mkl at the moment of enrollment
705122|NCT01823614|O1|Outcome|CD4 Cell Count > 500|Group which contains patients with CD4 nadir more than 500 cell/mkl at the moment of enrollment
705123|NCT01823614|O6|Outcome|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
705124|NCT01823614|O5|Outcome|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
705125|NCT01823614|O4|Outcome|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
705126|NCT01823614|O3|Outcome|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
705127|NCT01823614|O2|Outcome|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
705128|NCT01823614|O1|Outcome|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
705129|NCT01823614|E6|Reported Event|ARVT >3 Years|The group contains patients who have ARVT experience and obtain ART treatment more than 3 years
705130|NCT01823614|E5|Reported Event|ARVT From 6 Months to 3 Years|The group contains patients who have ARVT experience and obtain ART treatment from 6 months to 3 years
705131|NCT01823614|E4|Reported Event|ARVT <6 Months|The group contains patients who have ARVT experience and obtain ART treatment less than 6 months
705132|NCT01823614|E3|Reported Event|Naïve Patients, <350|The group contains patients who have not any ARV therapy experience and the level of CD4 count is less than 350 cells per mm3
705133|NCT01823614|E2|Reported Event|Naïve Patients, 350-500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is between 350 and 500 cells per mm3
705134|NCT01823614|E1|Reported Event|Naïve Patients, >500|The group contains patients who have not any ARV therapy experience and the level of CD4 count is more than 500 cells per mm3
705135|NCT01823536|B7|Baseline|Total|Total of all reporting groups
705136|NCT01823536|B6|Baseline|Not Assigned|Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate “not assigned” group in the FAS and excluded from the PPS. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study.
705137|NCT01823536|B5|Baseline|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705168|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705138|NCT01823536|B4|Baseline|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705139|NCT01823536|B3|Baseline|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705140|NCT01823536|B2|Baseline|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705141|NCT01823536|B1|Baseline|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705142|NCT01823536|P6|Participant Flow|Not Assigned|"Two subjects 2-5 years of age were randomized to receive another meningococcal ACWY vaccine (not the investigational product in the extension study) in the parent study and therefore not eligible for enrolment into the extension study. These subjects were inadvertently enrolled and completed the extension study. During analysis, these two subjects were included in a separate not assigned group in the Full Analysis Set and excluded from the Per Protocol Set. However, one of these subjects actually received the investigational vaccine (due to a randomization error) in the parent study and was included in the safety analyses under MenACWY-CRM_1 (≥7–≤10 Years) group in the extension study."
705143|NCT01823536|P5|Participant Flow|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705144|NCT01823536|P4|Participant Flow|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705145|NCT01823536|P3|Participant Flow|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705146|NCT01823536|P2|Participant Flow|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705147|NCT01823536|P1|Participant Flow|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705148|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705149|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705150|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705151|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
707191|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
705152|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705153|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705154|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705155|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705156|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705157|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705158|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705159|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705160|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705161|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705162|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705163|NCT01823536|O5|Outcome|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705164|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705165|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705166|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705167|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705431|NCT01822301|O3|Outcome|Facial Volume Score at 3 Month PO|facial volume score at 3 months post-operation
705169|NCT01823536|O4|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705170|NCT01823536|O3|Outcome|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705171|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705172|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705173|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705174|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705175|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705176|NCT01823536|O3|Outcome|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705177|NCT01823536|O2|Outcome|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705178|NCT01823536|O1|Outcome|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705179|NCT01823536|E5|Reported Event|Vaccine Naive (≥11–≤15 Years)|Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of MenACWY-CRM vaccine.
705180|NCT01823536|E4|Reported Event|MenACWY-CRM_1 (≥11–≤15 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 6-10 years of age, were administered 1 injection of MenACWY-CRM vaccine at 11-15 years of age.
705181|NCT01823536|E3|Reported Event|Vaccine Naive (≥7–≤10 Years)|Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of MenACWY-CRM vaccine.
705182|NCT01823536|E2|Reported Event|MenACWY-CRM_1 (≥7–≤10 Years)|Subjects who had previously received 1 injection of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705183|NCT01823536|E1|Reported Event|MenACWY-CRM_2 (≥7–≤10 Years)|Subjects who had previously received 2 injections of MenACWY-CRM vaccine at 2-5 years of age, were administered 1 injection of MenACWY-CRM vaccine at 7-10 years of age.
705248|NCT01823146|P1|Participant Flow|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
705184|NCT01823341|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
705185|NCT01823341|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
705186|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705187|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705188|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705189|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705190|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705191|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705192|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705193|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705194|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705195|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705196|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705197|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705198|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705199|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705200|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705201|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705202|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705203|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705204|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705249|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
705205|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705206|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705207|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705208|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705209|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705210|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705211|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705212|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705213|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705214|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705215|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705216|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705217|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705218|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705219|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705220|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705221|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705222|NCT01823341|O4|Outcome|Standard of Care (Participants 4-10 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705223|NCT01823341|O3|Outcome|Pump Suspension Algorithm (Participants 4-10 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705224|NCT01823341|O2|Outcome|Standard of Care (Participants 11-14 Years)|The control algorithm will run passively and not recommend control the patient's pump.
705225|NCT01823341|O1|Outcome|Pump Suspension Algorithm (Participants 11-14 Years)|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
705226|NCT01823341|E1|Reported Event|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
705227|NCT01823289|B1|Baseline|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
705228|NCT01823289|P1|Participant Flow|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
705229|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
705230|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
705231|NCT01823289|O1|Outcome|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
705232|NCT01823289|E1|Reported Event|Itraconazole Sequential Therapy|Itraconazole 200 milligram (mg) intravenous (directly into the vein) injection was given twice daily for first 2 days and once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily was given for 2 to 4 weeks.
705233|NCT01823224|B3|Baseline|Total|Total of all reporting groups
705234|NCT01823224|B2|Baseline|Group 2|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
705235|NCT01823224|B1|Baseline|Group 1|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
705267|NCT01822899|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
705268|NCT01822821|B3|Baseline|Total|Total of all reporting groups
705269|NCT01822821|B2|Baseline|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
706302|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
705236|NCT01823224|P2|Participant Flow|"Oral Acetaminophen 2 Capsules + IV Salt Water"|"Group 2 will receive an IV salt water infusion plus 2 capsules of oral acetaminophen 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses totaling or equaling 2000mg.~2 capsules Oral Tylenol 2000 mg and IV salt water: The participants randomized to receive the '2 capsules Oral Acetaminophenl 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
705237|NCT01823224|P1|Participant Flow|"IV Acetaminophen 1000mg + 2 Oral Sugar Pills"|"Group 1 will receive IV acetaminophen 1000mg plus 2 oral capsules sugar pills 1 hour prior to surgical incision and 4 hours after initial dose, for a total of two doses of acetaminophen totaling or equaling 2000mg~IV tylenol 1000mg and 2 oral capsule sugar pills: IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
705238|NCT01823224|O2|Outcome|Group 2|This group consisted of 22 subjects that received the oral acetaminophen and IV placebo. Of the 22 there was 1 male and 21 female.
705239|NCT01823224|O1|Outcome|Group 1|This group consisted of 28 subjects' data that was analyzed. Of the 28 there were 7 males 21 females.
705240|NCT01823224|O2|Outcome|Group 2|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times. There were no significant differences between the groups over time, Wilks’ Lambda (P = 0.875). (Table 4 and Figure 1)
705241|NCT01823224|O1|Outcome|Group 1|A Repeated Analyses of Variance was conducted to determine if there were significant differences between the IV and PO groups relative to pain over seven times.
705242|NCT01823224|E2|Reported Event|Group 2|No adverse events
705243|NCT01823224|E1|Reported Event|Group 1|.Found to have gangreouns gallbladder and stayed greater 24 hours; upon investigation found not related to the acetaminophen
705244|NCT01823146|B3|Baseline|Total|Total of all reporting groups
705245|NCT01823146|B2|Baseline|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN)
705246|NCT01823146|B1|Baseline|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
705247|NCT01823146|P2|Participant Flow|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
705250|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
705251|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
705252|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
705253|NCT01823146|O2|Outcome|Placebo Spray|single dose of 24 IU saline, self-administered intranasally (IN). This is an identical solution to the oxytocin spray but without the oxytocin.
705254|NCT01823146|O1|Outcome|Oxytocin Spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
705255|NCT01823146|E2|Reported Event|Placebo Spray|"single dose of 24 IU saline, self-administered intranasally (IN)~Placebo spray: single dose of 24 IU saline, self-administered intranasally (IN)"
705256|NCT01823146|E1|Reported Event|Oxytocin Spray|"single dose of 24 IU oxytocin, self-administered intranasally (IN)~Oxytocin spray: single dose of 24 IU oxytocin, self-administered intranasally (IN)"
705257|NCT01822899|B3|Baseline|Total|Total of all reporting groups
705258|NCT01822899|B2|Baseline|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
705259|NCT01822899|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
705260|NCT01822899|P2|Participant Flow|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
705261|NCT01822899|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
705262|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
705263|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
705264|NCT01822899|O2|Outcome|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
705265|NCT01822899|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg)/vilanterol (VI) 25 µg once daily (QD) each morning via a dry powder inhaler (DPI) and placebo twice daily (BID) (once in the morning and once in the evening) via a DPI for 12 weeks.
705266|NCT01822899|E2|Reported Event|FSC 500/50 µg|Participants received fluticasone propionate/salmeterol (FSC) 500 µg/50 µg BID (once in the morning and once in the evening) via a DPI and placebo administered QD via a DPI for 12 weeks.
705432|NCT01822301|O2|Outcome|Facial Volume Score at 7-21 Day PO|facial volume score at 7-21 days post-operation
705270|NCT01822821|B1|Baseline|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705271|NCT01822821|P2|Participant Flow|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705272|NCT01822821|P1|Participant Flow|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705273|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705274|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705275|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705276|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705277|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705278|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705279|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
707368|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
705280|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705281|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705282|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705283|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705284|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705285|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705286|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705287|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705288|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705289|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705290|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705334|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705291|NCT01822821|O2|Outcome|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705292|NCT01822821|O1|Outcome|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705293|NCT01822821|E2|Reported Event|Placebo|"Patients will receive up to four doses of IV placebo every six hours after surgery along with standard PCA (patient controlled) opioids.~Placebo: Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids."
705294|NCT01822821|E1|Reported Event|IV Acetaminophen|"Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.~IV Acetaminophen: Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids."
705295|NCT01822756|B6|Baseline|Total|Total of all reporting groups
705296|NCT01822756|B5|Baseline|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705297|NCT01822756|B4|Baseline|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705298|NCT01822756|B3|Baseline|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705299|NCT01822756|B2|Baseline|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705300|NCT01822756|B1|Baseline|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705301|NCT01822756|P5|Participant Flow|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705302|NCT01822756|P4|Participant Flow|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705303|NCT01822756|P3|Participant Flow|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705304|NCT01822756|P2|Participant Flow|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705305|NCT01822756|P1|Participant Flow|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705306|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705307|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705308|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705309|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705310|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705311|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705312|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705313|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705314|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705315|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705316|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705317|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705318|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705319|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705320|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705321|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705322|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705323|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705324|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705325|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705326|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705327|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705328|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705329|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705330|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705331|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705332|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705333|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705336|NCT01822756|O5|Outcome|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705337|NCT01822756|O4|Outcome|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705338|NCT01822756|O3|Outcome|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705339|NCT01822756|O2|Outcome|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705340|NCT01822756|O1|Outcome|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705341|NCT01822756|E5|Reported Event|Cohort B1|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; - GCSF given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19
705342|NCT01822756|E4|Reported Event|Cohort B0 (-GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; -GCSF
705343|NCT01822756|E3|Reported Event|Cohort B0 (+GCSF)|RUX 10 mg BID; Gemcitabine 1000 mg/m^2; nab-Paclitaxel 100 mg/m^2; +GCSF
705344|NCT01822756|E2|Reported Event|Cohort B (-1)|RUX Orally, Twice Daily 5 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15; nab-paclitaxel 100 mg/m^2 on Days 1, 8, and 15; + GCSF
705345|NCT01822756|E1|Reported Event|Cohort A0|RUX 15 mg BID; Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15
705346|NCT01822691|B1|Baseline|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705347|NCT01822691|P1|Participant Flow|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705348|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705349|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705350|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705351|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705352|NCT01822691|O1|Outcome|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705353|NCT01822691|E1|Reported Event|INCB024360 Treatment|Participants were treated with 600 mg orally, twice a day for 16 weeks, unless clear evidence of disease progression or toxicity was evident.
705354|NCT01822678|B4|Baseline|Total|Total of all reporting groups
705355|NCT01822678|B3|Baseline|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
705356|NCT01822678|B2|Baseline|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
705357|NCT01822678|B1|Baseline|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
705358|NCT01822678|P3|Participant Flow|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
705359|NCT01822678|P2|Participant Flow|ESL 600 mg|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
705360|NCT01822678|P1|Participant Flow|ESL 800 mg|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
705361|NCT01822678|O3|Outcome|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
705362|NCT01822678|O2|Outcome|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
705363|NCT01822678|O1|Outcome|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
705364|NCT01822678|E3|Reported Event|Placebo|"Group 3: Placebo (change in daily number of tablets administered, according to clinical response).~Placebo : Placebo, sugar pill"
705365|NCT01822678|E2|Reported Event|BIA 2-093 - 1800 mg (Maximum Dose)|"Group 2: Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response."
705366|NCT01822678|E1|Reported Event|BIA 2-093 - 2400 mg (Maximum Dose)|"Group 1: Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.~Eslicarbazepine Acetate : Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response."
705367|NCT01822665|B1|Baseline|All Randomized Participants|All randomized participants in the study who took at least one treatment dose.
705433|NCT01822301|O1|Outcome|Facial Volume Score at Baseline|facial volume score at baseline, pre-op
705368|NCT01822665|P1|Participant Flow|Overall Study|This was a randomized, 4-way crossover study. Participants received two fast dissolving paracetamol tablets (500 milligrams [mg]/tablet) four times daily (QID); two liquid-filled gelatin capsules containing ibuprofen (200 mg/capsule), three times daily (TID); two ibuprofen tablets (200 mg/tablet), TID; and, two fast dissolving placebo tablets QID. All the treatments were administered orally with water. There was a washout period of 7 days following every treatment session.
705369|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
705370|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablet (400 mg/tablet), were administered TID, orally with water.
705371|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
705372|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
705373|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
705374|NCT01822665|O3|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
705375|NCT01822665|O2|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
705376|NCT01822665|O1|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
705377|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
705378|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
705379|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
705380|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
705381|NCT01822665|O4|Outcome|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
705382|NCT01822665|O3|Outcome|Ibuprofen Tablet (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
705383|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), were administered TID, orally with water.
705384|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
705385|NCT01822665|O2|Outcome|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/tablet), was administered TID, orally with water.
705386|NCT01822665|O1|Outcome|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) was administered QID, orally with water.
705387|NCT01822665|E4|Reported Event|Placebo Tablet|Two placebo tablets were administered QID, orally with water.
705388|NCT01822665|E3|Reported Event|Ibuprofen Tablet (400 mg)|Two ibuprofen tablets (400 mg/tablet), were administered TID, orally with water.
705389|NCT01822665|E2|Reported Event|Ibuprofen Capsule (400 mg)|Two ibuprofen capsules (400 mg/capsule), were administered TID, orally with water.
705390|NCT01822665|E1|Reported Event|Paracetamol Tablet (1000 mg)|Two paracetamol tablets (500 mg/tablet) were administered QID, orally with water.
705391|NCT01822574|B4|Baseline|Total|Total of all reporting groups
705392|NCT01822574|B3|Baseline|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
705393|NCT01822574|B2|Baseline|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705394|NCT01822574|B1|Baseline|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705395|NCT01822574|P3|Participant Flow|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
705396|NCT01822574|P2|Participant Flow|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705397|NCT01822574|P1|Participant Flow|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705398|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
705426|NCT01822301|P1|Participant Flow|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
705427|NCT01822301|O3|Outcome|CT Imaging at 9 Months PO|CT imaging at 9 months post-operation
705399|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705400|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705401|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
705402|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705403|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705404|NCT01822574|O3|Outcome|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
705405|NCT01822574|O2|Outcome|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705445|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
705406|NCT01822574|O1|Outcome|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705407|NCT01822574|E3|Reported Event|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
705408|NCT01822574|E2|Reported Event|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705409|NCT01822574|E1|Reported Event|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
705410|NCT01822535|B3|Baseline|Total|Total of all reporting groups
705411|NCT01822535|B2|Baseline|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
705412|NCT01822535|B1|Baseline|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
705413|NCT01822535|P2|Participant Flow|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
705414|NCT01822535|P1|Participant Flow|Tetraplegia|Lesion level C3-T1, American Spinal Injury Association (ASIA) impairment levels A and B, ages 18-68 years
705415|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
705416|NCT01822535|O2|Outcome|Able-bodied (AB)|Age- and gender-matched to individuals with tetraplegia.
705417|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
705418|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
705419|NCT01822535|O1|Outcome|Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
705420|NCT01822535|O2|Outcome|Able-bodied|Age- and gender-matched to individuals with tetraplegia.
705421|NCT01822535|O1|Outcome|Tetraplegia|Lesion level T1 and above, ASIA levels A and B, ages 18-68 years
705422|NCT01822535|E3|Reported Event|Drug: Tetraplegia|Those individuals with tetraplegia who completed visit 1 of testing (i.e. no drug)
705423|NCT01822535|E2|Reported Event|No Drug: Able-bodied|Age- and gender-matched to individuals with tetraplegia.
705424|NCT01822535|E1|Reported Event|No Drug: Tetraplegia|Lesion level C3-T1, ASIA levels A and B, ages 18-68 years
705425|NCT01822301|B1|Baseline|Repeat Facial Fat Grafting|Repeat Fat grafting: Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. We treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. .
705428|NCT01822301|O2|Outcome|CT Imaging at 3 Months PO|CT imaging at 3 months post-operation
705434|NCT01822301|E1|Reported Event|Repeat Facial Fat Grafting|Repeat Fat grafting: treat 5 subjects from protocol IRB # PRO09060101 with an additional fat graft treatment to assess whether this will increase fat graft retention over time.
705435|NCT01822223|B3|Baseline|Total|Total of all reporting groups
705436|NCT01822223|B2|Baseline|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705437|NCT01822223|B1|Baseline|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705438|NCT01822223|P2|Participant Flow|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
705439|NCT01822223|P1|Participant Flow|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
705440|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
705441|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
705442|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
705443|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|Laser-ablated dental implant abutments will be attached to surgically placed dental implants.
705444|NCT01822223|O2|Outcome|Smooth Implant-abutments|Smooth dental implant-abutments will be attached to surgically placed dental implants.
705446|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705447|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705448|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705449|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705450|NCT01822223|O2|Outcome|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705451|NCT01822223|O1|Outcome|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705452|NCT01822223|E2|Reported Event|Smooth Implant-abutments|"Smooth dental implant-abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705453|NCT01822223|E1|Reported Event|Laser-ablated Dental Implant-abutments|"Laser-ablated dental implant abutments will be attached to surgically placed dental implants.~Dental implant-abutments: At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
705454|NCT01822197|B1|Baseline|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
705455|NCT01822197|P1|Participant Flow|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
705456|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
705457|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
705458|NCT01822197|O1|Outcome|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
705459|NCT01822197|E1|Reported Event|Phototherapy|"Bright light phototherapy will be administered for 30 minutes daily over one week in the morning (Days 0-7)~Phototherapy: light will be administered at a minimum distance of 12 inches away to provide 10,000 lux"
705460|NCT01822119|B1|Baseline|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705461|NCT01822119|P1|Participant Flow|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705462|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705463|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705464|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705465|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705466|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705467|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705468|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705469|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705470|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705471|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705472|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705473|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705474|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705475|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705476|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705477|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705478|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705479|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705480|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705481|NCT01822119|O1|Outcome|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705982|NCT01817790|P2|Participant Flow|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705482|NCT01822119|E1|Reported Event|Baha Attract System|"This transcutaneous solution is based on a magnet coupling using magnets on both side of the skin;~One implant magnet~One external magnet on which a sound processor is attached, i.e. the Sound Processor magnet (SP magnet)~Baha Attract System"
705483|NCT01821963|B1|Baseline|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
705484|NCT01821963|P1|Participant Flow|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
705485|NCT01821963|O1|Outcome|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
705486|NCT01821963|E1|Reported Event|Pegylated Interferon Alfa 2a + Ribavirin + Telaprevir|Triple combination with Telaprevir, PegIFN alfa-2a and Ribavirin administered for 12 weeks, followed by dual therapy with PegIFN alfa-2a and Ribavirin. Dual therapy continued for 48 weeks of total duration of therapy, as standard of care treatment for cirrhotic patients, or until day of transplantation, whichever comes first. Starting doses for standard of care Pegylated Interferon (PegIFN) alfa-2a 180 mcg subcutaneously once weekly, for Ribavirin (RBV) 1,000 mg orally daily (< 75 kg) and 1,200 mg orally daily (≥ 75 kg), and for Telaprevir 750 mg taken orally 3 times a day.
705487|NCT01821937|B3|Baseline|Total|Total of all reporting groups
705488|NCT01821937|B2|Baseline|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705489|NCT01821937|B1|Baseline|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705535|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705490|NCT01821937|P2|Participant Flow|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705491|NCT01821937|P1|Participant Flow|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705492|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705493|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705494|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705495|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705496|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705497|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705498|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705499|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705500|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705501|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705502|NCT01821937|O2|Outcome|Faldaprevir 240 mg|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705503|NCT01821937|O1|Outcome|Faldaprevir 120 mg|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705504|NCT01821937|E4|Reported Event|Faldaprevir 240 mg Multiple Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705505|NCT01821937|E3|Reported Event|Faldaprevir 240 mg Single Dose|"Oral administration of Faldaprevir 240 mg (BI 201335) soft gel capsule~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
705506|NCT01821937|E2|Reported Event|Faldaprevir 120 mg Multiple Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the multiple dose treatment (days 6-15), subjects received multiple oral doses of faldaprevir once daily from day 6 to day 15."
705507|NCT01821937|E1|Reported Event|Faldaprevir 120 mg Single Dose|"Oral administration of Faldaprevir 120 mg (BI 201335) soft gel capsule.~The study was divided into two phases, the first being a single dose and the second a multiple dose.~During the single dose treatment (days 1-5), subjects received one single dose in the morning of day 1."
705508|NCT01821859|B1|Baseline|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
705509|NCT01821859|P1|Participant Flow|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
705510|NCT01821859|O1|Outcome|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
705511|NCT01821859|E1|Reported Event|Abraxane/Bevacizumab|"Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.~Bevacizumab : Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.~Abraxane : Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion."
705512|NCT01821807|B3|Baseline|Total|Total of all reporting groups
706486|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
705513|NCT01821807|B2|Baseline|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
705514|NCT01821807|B1|Baseline|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
705515|NCT01821807|P2|Participant Flow|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
705516|NCT01821807|P1|Participant Flow|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
705517|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
705518|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
705519|NCT01821807|O2|Outcome|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
705520|NCT01821807|O1|Outcome|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
705521|NCT01821807|E2|Reported Event|26 Gauge Atraucan|Patients (n=110) will be treated with 26 gauge atraucan spinal needle for spinal anesthesia for cesarean section.
705522|NCT01821807|E1|Reported Event|26 Gauge Quincke|Patients (n=150) will be treated with 26 gauge quincke spinal needle for spinal anesthesia for cesarean section.
705523|NCT01821534|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was administered.
705524|NCT01821534|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was administered.
705525|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
705526|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
705527|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
705528|NCT01821534|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was administered.
705529|NCT01821534|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was administered.
705530|NCT01821417|B3|Baseline|Total|Total of all reporting groups
705531|NCT01821417|B2|Baseline|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705532|NCT01821417|B1|Baseline|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705533|NCT01821417|P2|Participant Flow|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705534|NCT01821417|P1|Participant Flow|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705576|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
705577|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
705536|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705537|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705538|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705539|NCT01821417|O2|Outcome|Dental Implant|"Randomized dental implant treatment with machined-collar implants~Dental implant treatment: Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705540|NCT01821417|O1|Outcome|Microtextured Dental Implant|"Randomized for microtextured dental implant treatment~Microtextured dental implant treatment: Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists."
705541|NCT01821417|E2|Reported Event|Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.~Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
705542|NCT01821417|E1|Reported Event|Microtextured Dental Implant|"Serious adverse events are defined as life threatening events that occur during the course of the study treatment that may or may not be related to study protocols and procedures.~Other adverse events are defined as non-life threatening events that are unexpected after the routine performance of the study protocols and procedures. These may or may not be related to the study protocols and procedures."
705543|NCT01821378|B4|Baseline|Total|Total of all reporting groups
705544|NCT01821378|B3|Baseline|Placebo|Placebo: Once Daily
705545|NCT01821378|B2|Baseline|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
705546|NCT01821378|B1|Baseline|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
705547|NCT01821378|P3|Participant Flow|Placebo|"Placebo Comparator 20 or 80 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
705548|NCT01821378|P2|Participant Flow|Lurasidone 80 mg - 160 mg|"Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
705549|NCT01821378|P1|Participant Flow|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily~Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2: Lurasidone 80 mg once daily~Placebo: Once Daily"
705550|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
705551|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
705552|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
705553|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
705554|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
705555|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
705556|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
705557|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
705558|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
705559|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
705560|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
705561|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
705562|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
705563|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
705564|NCT01821378|O3|Outcome|Placebo|Randomized to Placebo group at baseline
705565|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
705566|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
705567|NCT01821378|O2|Outcome|ENR Lurasidone 160 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 160 mg/day at week 2.
705568|NCT01821378|O1|Outcome|ENR Lurasidone 80 mg|Subjects who are only non-responders on Lurasidone 80 mg/day and randomized to Lurasidone 80 mg/day at week 2.
705569|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
705570|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
705571|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone 20 mg once daily
705572|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
705573|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
705574|NCT01821378|O1|Outcome|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
705575|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
705578|NCT01821378|O3|Outcome|Placebo|Placebo: Once Daily
705579|NCT01821378|O2|Outcome|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2
705580|NCT01821378|O1|Outcome|Lurasidone 20 mg|"Lurasidone 20 mg once daily~Lurasidone: Lurasidone 20 mg once daily"
705581|NCT01821378|E3|Reported Event|Placebo|Placebo: Once Daily
705582|NCT01821378|E2|Reported Event|Lurasidone 80-160 mg|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2 (one subject who was randomized was not treated with study drug, therefore, excluded from the safety population).
705583|NCT01821378|E1|Reported Event|Lurasidone 20 mg|Lurasidone: Lurasidone 20 mg once daily
705584|NCT01821352|B3|Baseline|Total|Total of all reporting groups
705585|NCT01821352|B2|Baseline|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
705586|NCT01821352|B1|Baseline|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
705587|NCT01821352|P2|Participant Flow|Placebo Laser|Placebo Laser device emits sham green light that has no therapeutic effect.
705588|NCT01821352|P1|Participant Flow|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW) 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
705589|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
705590|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
705591|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
705592|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
705593|NCT01821352|O2|Outcome|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
705835|NCT01819272|P2|Participant Flow|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705594|NCT01821352|O1|Outcome|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
705595|NCT01821352|E2|Reported Event|Placebo Laser|Placebo Laser device emitting sham green light that has no therapeutic effect.
705596|NCT01821352|E1|Reported Event|Erchonia Obesity Laser|The Erchonia® Obesity Laser is made up of 10 independent 17 milliWatts (mW), 532 nanometer (nm) green laser diodes, each diode positioned 120 degrees apart from the next with each titled at a 30 degree angle. The Erchonia® Obesity Laser is a pulsed wave variable frequency device.
705597|NCT01821326|B1|Baseline|Patients With Obscure Gastrointestinal Bleeding|
705598|NCT01821326|P1|Participant Flow|Patients With Obscure Gastrointestinal Bleeding|
705599|NCT01821326|O1|Outcome|Patients With Obscure Gastrointestinal Bleeding|
705600|NCT01821326|E1|Reported Event|Patients With Obscure Gastrointestinal Bleeding|
705601|NCT01821118|B3|Baseline|Total|Total of all reporting groups
705602|NCT01821118|B2|Baseline|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705603|NCT01821118|B1|Baseline|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705604|NCT01821118|P2|Participant Flow|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705605|NCT01821118|P1|Participant Flow|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705606|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705607|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705608|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705609|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705610|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705611|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705670|NCT01820559|E3|Reported Event|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
705612|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705613|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705614|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705615|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705616|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705617|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705618|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705619|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705620|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705836|NCT01819272|P1|Participant Flow|Placebo|Placebo once daily in the morning
707699|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
705621|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705622|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705623|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705624|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705625|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705626|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705627|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705628|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705629|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705630|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705631|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705632|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705633|NCT01821118|O2|Outcome|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705634|NCT01821118|O1|Outcome|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705635|NCT01821118|E2|Reported Event|Placebo|Participants received a loading dose of placebo matching PF-04360365 10 mg/kg on Day 1, followed by placebo matching PF-04360365 7.5 mg/kg on Days 30 and 60. Placebo was also administered via IV infusion over a period of 10-15 min.
705671|NCT01820559|E2|Reported Event|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
705636|NCT01821118|E1|Reported Event|PF-04360365|Participants received a loading dose of PF-04360365 10 milligrams (mg)/kilograms (kg) on Day 1, followed by PF-04360365 7.5 mg/kg on Days 30 and 60. PF-04360365 was administered via intravenous (IV) infusion over a period of 10-15 minutes (min) and dosing was based on participant weight.
705637|NCT01821105|B1|Baseline|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
705638|NCT01821105|P1|Participant Flow|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
705639|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
705640|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
705641|NCT01821105|O1|Outcome|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
705642|NCT01821105|E1|Reported Event|Preoperative PET and CT Scans|"Patients undergo preoperative whole-body PET scans and CT scans of the abdomen and pelvis. Patients then receive fluoro-deoxyglucose (FDG)IV 60-90 minutes prior to surgery and undergo intraoperative CT scans using a handheld probe and computer navigation system.~PET Scan: All patients will receive whole body PET scans (chest-abdomen-pelvis).~CT Scan: All patients will receive CT scans of the abdomen and pelvis with contrast.~fludeoxyglucose F 18: Given IV~computer-aided detection/diagnosis: Undergo computer-aided detection/diagnosis during surgery"
705643|NCT01820585|B5|Baseline|Total|Total of all reporting groups
705644|NCT01820585|B4|Baseline|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705645|NCT01820585|B3|Baseline|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705646|NCT01820585|B2|Baseline|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705647|NCT01820585|B1|Baseline|Placebo|"Tablets~Placebo : Tablets"
705648|NCT01820585|P4|Participant Flow|ESL 1200 mg|ESL was supplied in 400-mg and 600-mg tablets and was administered QD by oral route.
705649|NCT01820585|P3|Participant Flow|ESL 800 mg|ESL 800 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route
705650|NCT01820585|P2|Participant Flow|ESL 400 mg|Eslicarbazepine acetate (ESL) 400 mg : ESL was supplied in 400-mg tablets and was administered QD by oral route.
705651|NCT01820585|P1|Participant Flow|Placebo|Placebo tablets matching the 400-mg and 600-mg tablets were administered Once daily (QD) by oral route.
705652|NCT01820585|O4|Outcome|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705653|NCT01820585|O3|Outcome|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705654|NCT01820585|O2|Outcome|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705655|NCT01820585|O1|Outcome|Placebo|"Tablets~Placebo : Tablets"
705656|NCT01820585|E4|Reported Event|ESL 1200 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 1200 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705657|NCT01820585|E3|Reported Event|ESL 800 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 800 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705658|NCT01820585|E2|Reported Event|ESL 400 mg|"Eslicarbazepine acetate (BIA 2-093) tablets~ESL 400 mg : Eslicarbazepine acetate (BIA 2-093) tablets"
705659|NCT01820585|E1|Reported Event|Placebo|"Tablets~Placebo : Tablets"
705660|NCT01820559|B4|Baseline|Total|Total of all reporting groups
705661|NCT01820559|B3|Baseline|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
705662|NCT01820559|B2|Baseline|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
705663|NCT01820559|B1|Baseline|Placebo|"Placebo tablets~Placebo : Tablets"
705664|NCT01820559|P3|Participant Flow|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
705665|NCT01820559|P2|Participant Flow|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
705666|NCT01820559|P1|Participant Flow|Placebo|"Placebo tablets~Placebo : Tablets"
705667|NCT01820559|O3|Outcome|ESL 1200 mg|"eslicarbazepine acetate 1200 mg~ESL 1200 mg :"
705668|NCT01820559|O2|Outcome|ESL 800 mg|"eslicarbazepine acetate 800 mg~ESL 800 mg :"
705669|NCT01820559|O1|Outcome|Placebo|"Placebo tablets~Placebo : Tablets"
705674|NCT01820416|B3|Baseline|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
705675|NCT01820416|B2|Baseline|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
705676|NCT01820416|B1|Baseline|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
705677|NCT01820416|P3|Participant Flow|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
705678|NCT01820416|P2|Participant Flow|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
705679|NCT01820416|P1|Participant Flow|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
705680|NCT01820416|O3|Outcome|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
705706|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705681|NCT01820416|O2|Outcome|Disabled Laser|"Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Placebo Comparator: Disabled Laser: Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation."
705682|NCT01820416|O1|Outcome|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
705683|NCT01820416|E3|Reported Event|Control|Visit laboratory using same schedule as experiment and placebo. No Low-level laser or any treatment applied. Used to assess normal test-retest variability.
705684|NCT01820416|E2|Reported Event|Disabled Laser|Low-level laser device with laser diodes disabled. Also applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.
705685|NCT01820416|E1|Reported Event|Low-Level Laser Therapy|"Low-level laser applied for approximately 4 minutes to the area around the pinna, the back of the neck, and the top of the head.~Low-level Laser Therapy: Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds."
705686|NCT01820364|B1|Baseline|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
705687|NCT01820364|P2|Participant Flow|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
705688|NCT01820364|P1|Participant Flow|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
705689|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
705690|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
705691|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
705692|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
705693|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
705694|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
705695|NCT01820364|O1|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
705696|NCT01820364|O2|Outcome|Part II: CLGX818 + MEK162|As per the original study design, Part II was to have five arms corresponding to the five potential combination treatments; however, only one patient was treated in this part of the study and received LGX818 in combination with MEK162.
705697|NCT01820364|O1|Outcome|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
705698|NCT01820364|E1|Reported Event|Part I: LGX818 - Single Agent|Subjects in Part I of the study received LGX818 as a single agent.
705699|NCT01819935|B3|Baseline|Total|Total of all reporting groups
705700|NCT01819935|B2|Baseline|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705701|NCT01819935|B1|Baseline|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705702|NCT01819935|P2|Participant Flow|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705703|NCT01819935|P1|Participant Flow|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705704|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705705|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
706603|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
705707|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705708|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705709|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705710|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705711|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705712|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705713|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705714|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705715|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705716|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705717|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705718|NCT01819935|O2|Outcome|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705719|NCT01819935|O1|Outcome|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705720|NCT01819935|E2|Reported Event|Vancomycin|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an ICD-9 code for MRSA and pneumonia, who had initiated and received at least 3 days of continuous intravenous vancomycin therapy in the hospital, were analyzed retrospectively.
705721|NCT01819935|E1|Reported Event|Linezolid|Participants who were admitted to veterans affairs hospitals between 1 January 2001 and 30 September 2010 (3559 days) with an international classification of diseases – revision 9 (ICD-9) code for methicillin-resistant staphylococcus aureus (MRSA) and pneumonia, who had initiated and received at least 3 days of continuous intravenous or oral linezolid therapy in the hospital, were analyzed retrospectively.
705722|NCT01819922|B1|Baseline|Overall Participants|All randomized participants who received single dose of PF-05175157 600 mg capsule or single dose of placebo matched to PF-05175157 600 mg capsule in either first or second intervention period.
705723|NCT01819922|P2|Participant Flow|Placebo Then PF-05175157|Participants who met the pre-defined CPET criteria, received single dose of placebo matched to PF-05175157, 600 mg capsule orally in first intervention period then single dose of PF-05175157 600 mg capsule orally in second intervention period. A washout period at least of 7-10 days was maintained between each intervention period.
705724|NCT01819922|P1|Participant Flow|PF-05175157 Then Placebo|Participants who met the pre-defined cardiopulmonary exercise test (CPET) criteria, received single dose of PF-05175157 600 milligram (mg) capsule orally in first intervention period then single dose of placebo matched to PF-05175157 capsule, 600 mg orally in second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705725|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
707747|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
705726|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705727|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705728|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705729|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705730|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705731|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705732|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705733|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705734|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705735|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705736|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705737|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705738|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705739|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705740|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705741|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705742|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705743|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705744|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705745|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705746|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705747|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705748|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705749|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705834|NCT01819272|P3|Participant Flow|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705750|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705751|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705752|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705753|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705754|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705755|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705756|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705757|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705758|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705759|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705760|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705761|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705762|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705763|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705764|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705765|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705818|NCT01819415|O2|Outcome|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
705766|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705767|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705768|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705769|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705770|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705771|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705772|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705773|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705774|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705775|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705776|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705777|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705778|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705779|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705780|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705781|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705782|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705783|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705784|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705785|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705786|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705787|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705788|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705789|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705819|NCT01819415|O1|Outcome|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
705790|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705791|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705792|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705793|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705794|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705795|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705796|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705797|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705798|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705799|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705800|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705801|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705802|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705803|NCT01819922|O2|Outcome|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705804|NCT01819922|O1|Outcome|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705805|NCT01819922|E2|Reported Event|Placebo|Participants who met the pre-defined CPET criteria received single dose of placebo matched to PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705806|NCT01819922|E1|Reported Event|PF-05175157 600 mg|Participants who met the pre-defined CPET criteria received single dose of PF-05175157 600 mg capsule orally in either first or second intervention period. A washout period of at least 7-10 days was maintained between each intervention period.
705807|NCT01819415|B5|Baseline|Total|Total of all reporting groups
705808|NCT01819415|B4|Baseline|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
705809|NCT01819415|B3|Baseline|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
705810|NCT01819415|B2|Baseline|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
705811|NCT01819415|B1|Baseline|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
705812|NCT01819415|P4|Participant Flow|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
705813|NCT01819415|P3|Participant Flow|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
705814|NCT01819415|P2|Participant Flow|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
705815|NCT01819415|P1|Participant Flow|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
705816|NCT01819415|O4|Outcome|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
705817|NCT01819415|O3|Outcome|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
705887|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705820|NCT01819415|E4|Reported Event|Group 4 - Control|Patients undergoing vitrectomy surgery for epiretinal membrane or macular hole had their vitreous samples to serve as controls.
705821|NCT01819415|E3|Reported Event|Group 1 - Anti-VEGF Plus AREDS-2|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-2 supplementation formula, that includes Omega-3 metabolites (DHA and EPA).
705822|NCT01819415|E2|Reported Event|Group 2 - Anti-VEGF Plus AREDS-1 Supplementation.|Patients already receiving intravitreal anti-VEGF treatment assigned to take AREDS-1 plus Lutein supplementation formula.
705823|NCT01819415|E1|Reported Event|Group 3 - Naive|Patients starting on intravitreal anti-VEGF treatment, not receiving Omega-3 supplements. They serve as wet-AMD controls.
705824|NCT01819272|B7|Baseline|Total|Total of all reporting groups
705825|NCT01819272|B6|Baseline|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705826|NCT01819272|B5|Baseline|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705827|NCT01819272|B4|Baseline|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705828|NCT01819272|B3|Baseline|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705829|NCT01819272|B2|Baseline|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705830|NCT01819272|B1|Baseline|Placebo|Placebo once daily in the morning
705831|NCT01819272|P6|Participant Flow|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705832|NCT01819272|P5|Participant Flow|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705833|NCT01819272|P4|Participant Flow|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
707927|NCT01806857|E2|Reported Event|Matching Placebo|Includes all subjects that took matching placebo
705837|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705838|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705839|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705840|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705841|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705842|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
705843|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705844|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705845|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705846|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705847|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705848|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
705849|NCT01819272|O6|Outcome|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705850|NCT01819272|O5|Outcome|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705851|NCT01819272|O4|Outcome|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705852|NCT01819272|O3|Outcome|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705853|NCT01819272|O2|Outcome|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705854|NCT01819272|O1|Outcome|Placebo|Placebo once daily in the morning
705855|NCT01819272|E6|Reported Event|2000 mg XR|"2000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705856|NCT01819272|E5|Reported Event|1000 mg XR|"1000 mg extended-release metformin once daily in the evening~Met XR: metformin extended-release tablets"
705857|NCT01819272|E4|Reported Event|1000 mg DR|"1000 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705858|NCT01819272|E3|Reported Event|800 mg DR|"800 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705859|NCT01819272|E2|Reported Event|600 mg DR|"600 mg delayed-release metformin once daily in the morning~Met DR: metformin delayed-release tablets"
705860|NCT01819272|E1|Reported Event|Placebo|Placebo once daily in the morning
705861|NCT01819194|B1|Baseline|Dispensed Subjects|All subjects that were dispensed the study lens.
705862|NCT01819194|P1|Participant Flow|Overall|Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
705863|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
705864|NCT01819194|O1|Outcome|Senofilcon A, 38% Water|Senofilcon A, 38% water
705865|NCT01819194|E1|Reported Event|Senofilcon A, 38% Water|Senofilcon A, 38% water
705866|NCT01818700|B1|Baseline|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
705888|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
706303|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
705867|NCT01818700|P1|Participant Flow|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
705868|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
705869|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
705900|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705901|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705902|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705870|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
705871|NCT01818700|O1|Outcome|Single Arm - Norspan Patch (Buprenorphine)|This study is single arm for Norspan(buprenorphine) patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
705872|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|"This trial is single arm with Norspan patch. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
705873|NCT01818700|O1|Outcome|Single Arm-Norspan Patch (Buprenorphine)|This study is single study with buprenorphine. Treatment with NORSPAN Ò will be started from 5 μg/h (1 patch a week) for 2 weeks, and proper titration (up-titration) will be allowed at visit 2(wk 2) and at visit 3(wk 4) according to the investigator’s decision. The up-titration will be considered by investigator’s judgement as follows; (1) if the rescue medication was used more than 2 times per day, on average or (2) based on the daily average NRS(Numeric Rating Scale), if the NRS was changed to worsen since the previous visit, (3) Investigator’s judgement by considering any titration needed situation (e.g. dose, frequency of rescue medication).
705874|NCT01818700|E1|Reported Event|Norspan Patch (Buprenorphine)|"Trade name is Norspan. Buprenorphine 5μg/h, 10 μg/h, 20 μg/h patches will be used (4 patches a box). Patch will be administered every 7th day.~Buprenorphine: 8weeks treatment with Norspan®(Buprenorphine)"
705875|NCT01818596|B3|Baseline|Total|Total of all reporting groups
705876|NCT01818596|B2|Baseline|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705877|NCT01818596|B1|Baseline|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705878|NCT01818596|P2|Participant Flow|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705879|NCT01818596|P1|Participant Flow|Cohort 1 (Treatment-experienced)|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
705880|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705881|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705882|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705883|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705884|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705885|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705886|NCT01818596|O1|Outcome|All Participants|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks
705889|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705890|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705891|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705892|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705893|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705894|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705895|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705896|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705897|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705898|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705899|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705903|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705904|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705905|NCT01818596|O2|Outcome|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-naive participants
705906|NCT01818596|O1|Outcome|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in ART-experienced participants
705907|NCT01818596|E2|Reported Event|Cohort 2 (Treatment-naive)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-naive participants
705908|NCT01818596|E1|Reported Event|Cohort 1 (Treatment-experienced)|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food for 144 weeks in antiretroviral treatment (ART)-experienced participants
705909|NCT01818414|B3|Baseline|Total|Total of all reporting groups
705910|NCT01818414|B2|Baseline|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
705911|NCT01818414|B1|Baseline|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
705912|NCT01818414|P2|Participant Flow|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
705913|NCT01818414|P1|Participant Flow|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
705914|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
705915|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
705916|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
705917|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
705918|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
705919|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
705920|NCT01818414|O2|Outcome|Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
705921|NCT01818414|O1|Outcome|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.
705922|NCT01818414|O2|Outcome|Folic Acid|"Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S~Folic Acid"
705923|NCT01818414|O1|Outcome|Misoprostol|"Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S.~Misoprostol"
705924|NCT01818414|E2|Reported Event|Placebo Comparator: Folic Acid|Folic acid 4 mg buccally 3 hours prior to D&E as an adjunct to same-day Dilapan-S
705925|NCT01818414|E1|Reported Event|Misoprostol|Misoprostol 400 mcg buccal 3 hours prior to D&E as an adjunct to same-day Dilapan-S
705926|NCT01818336|B1|Baseline|Safety Population|All subjects who had skin testing performed (i.e., administered any component of the Penicillin Skin Test Kit).
705927|NCT01818336|P2|Participant Flow|Subjects in Retest Population|All subjects who initially tested positive to any of the initial skin tests with penicillin reagents and subsequently returned after 4 weeks for retesting.
705928|NCT01818336|P1|Participant Flow|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine and control results were valid) and who received the oral amoxicillin challenge.
705929|NCT01818336|O1|Outcome|Intent-to-Treat Population|All subjects who had valid skin testing performed (i.e., administered all components of the Penicillin Skin Test Kit and the histamine control results are valid) and who receive the oral amoxicillin challenge.
705930|NCT01818336|E3|Reported Event|Subjects With AE Related to Oral Amox Challenge|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
705931|NCT01818336|E2|Reported Event|Subjects With AE Related to Skin Testing|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s)."
705932|NCT01818336|E1|Reported Event|Safety Population-All Study-Emergent Adverse Events|"Intervention: Penicillin skin test kit~The skin test procedure first involved puncture testing. Subjects who had negative skin puncture test results to any of the drug antigens contained within the Penicillin Skin Test Kit then underwent intradermal testing in duplicate. Subjects who had any positive skin test to drug antigens in the Penicillin Skin Test Kit were asked to return in 4 weeks to confirm the positive test(s). Subjects who had negative puncture and intradermal test results were given the oral amoxicillin challenge, which was comprised of a single, age-dependent, full oral dose of amoxicillin. The purpose of the oral amoxicillin challenge was to confirm absence of allergy and confirm the NPV of skin testing. Subjects were monitored at the study site for 1 hour following oral amoxicillin challenge and then sent home. The study site followed up by telephone with all subjects ≥72 hours after administration of the oral amoxicillin challenge."
705933|NCT01817907|B3|Baseline|Total|Total of all reporting groups
705934|NCT01817907|B2|Baseline|Trazodone First|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
705935|NCT01817907|B1|Baseline|Placebo First|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
705936|NCT01817907|P2|Participant Flow|Trazodone First|Subjects will receive a pill of trazodone (100 mg) during their first sleep study night and will receive a sugar pill (placebo) during their second sleep study night.
705937|NCT01817907|P1|Participant Flow|Placebo First|Subjects will receive a sugar pill (placebo) during their first sleep study night and will receive a pill of trazodone (100 mg) during their second sleep study night.
705938|NCT01817907|O2|Outcome|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
705939|NCT01817907|O1|Outcome|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
705940|NCT01817907|O2|Outcome|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
705941|NCT01817907|O1|Outcome|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
705942|NCT01817907|E2|Reported Event|Trazodone|"Subjects will receive trazodone during their treatment night sleep study~Trazodone: Subjects will receive trazodone during one of their treatment arm studies"
705943|NCT01817907|E1|Reported Event|Placebo|"Subjects will receive a sugar pill during their placebo night sleep study.~Placebo pill: Subjects will receive a sugar pill during the placebo arm"
705944|NCT01817855|B5|Baseline|Total|Total of all reporting groups
705945|NCT01817855|B4|Baseline|Placebo COPD|COPD Patients with Placebo, once daily
705946|NCT01817855|B3|Baseline|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
705947|NCT01817855|B2|Baseline|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
705948|NCT01817855|B1|Baseline|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
705949|NCT01817855|P4|Participant Flow|Placebo COPD|COPD Patients with Placebo, once daily
705950|NCT01817855|P3|Participant Flow|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
705951|NCT01817855|P2|Participant Flow|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
705952|NCT01817855|P1|Participant Flow|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
705953|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
705954|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
705955|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
705956|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
705957|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
705958|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
705959|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
705960|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
705961|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
705962|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
705963|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
705964|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
705965|NCT01817855|O6|Outcome|AZD7624 Healthy Volunteers Cohort 3|Healthy volunteers on Cohort 3 with 1027 µg delivered dose of AZD7624, twice daily
705966|NCT01817855|O5|Outcome|AZD7624 Healthy Volunteers Cohort 2|Healthy volunteers on Cohort 2 with 522 µg delivered dose of AZD7624, twice daily
705967|NCT01817855|O4|Outcome|AZD7624 Healthy Volunteers Cohort 1|Healthy volunteers on Cohort 1 with 261 µg delivered dose of AZD7624, twice daily
705968|NCT01817855|O3|Outcome|AZD7624 COPD Cohort 6|COPD patients on Cohort 6 with 966 µg delivered dose of AZD7624, once daily
705969|NCT01817855|O2|Outcome|AZD7624 Healthy Volunteers Cohort 5|Healthy volunteers on Cohort 5 with 2053 µg delivered dose of AZD7624 , once daily
705970|NCT01817855|O1|Outcome|AZD7624 COPD Cohort 4|COPD patients on Cohort 4 with 1932 µg delivered dose of AZD7624 , once daily
705971|NCT01817855|O4|Outcome|Placebo COPD|COPD Patients with Placebo, once daily
705972|NCT01817855|O3|Outcome|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
705973|NCT01817855|O2|Outcome|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
705974|NCT01817855|O1|Outcome|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
705975|NCT01817855|E4|Reported Event|Placebo COPD|COPD Patients with Placebo, once daily
705976|NCT01817855|E3|Reported Event|AZD7624 COPD|COPD patients with 966 µg or 1932 µg delivered dose of AZD7624, once daily
705977|NCT01817855|E2|Reported Event|Placebo Healthy Volunteers|Healthy Volunteers with Placebo, once daily or twice daily
705978|NCT01817855|E1|Reported Event|AZD7624 Healthy Volunteers|Healthy Volunteers with 261 µg to 2053 µg delivered dose of AZD7624, once daily or twice daily
705979|NCT01817790|B3|Baseline|Total|Total of all reporting groups
705980|NCT01817790|B2|Baseline|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705981|NCT01817790|B1|Baseline|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705983|NCT01817790|P1|Participant Flow|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705984|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705985|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705986|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705987|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705988|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705989|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705990|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705991|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705992|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705993|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705994|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705995|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705996|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705997|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
705998|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
705999|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706000|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706001|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706002|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706003|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706004|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706005|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706006|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706007|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706008|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706229|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
706009|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706010|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
706011|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706012|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning
706013|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706014|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706015|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706016|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706017|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706018|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706019|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706020|NCT01817790|O2|Outcome|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706021|NCT01817790|O1|Outcome|Fluticasone Propionate Nasal Spray|Fluticasone propionate nasal spray with strength per dose of 50 mcg/spray. Two sprays of study treatment per nostril to be administered in morning.
706022|NCT01817790|E2|Reported Event|Placebo Nasal Spray|Two sprays of placebo per nostril to be administered in morning.
706023|NCT01817790|E1|Reported Event|Fluticasone Propionate Nasal Spray|Two sprays of Fluticasone propionate nasal spray (50 mcg/spray) per nostril to be administered in morning (Total dose 200 mcg).
706024|NCT01817777|B3|Baseline|Total|Total of all reporting groups
706025|NCT01817777|B2|Baseline|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706026|NCT01817777|B1|Baseline|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706027|NCT01817777|P3|Participant Flow|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706028|NCT01817777|P2|Participant Flow|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706029|NCT01817777|P1|Participant Flow|Routine Metformin|Participants were followed during an 8-week Observational Phase. During this phase, participants visited the pharmacy and purchased metformin (MTF) as per their usual routines.
706030|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706031|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706032|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706033|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706034|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706035|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706036|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706037|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706038|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706039|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706040|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706041|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706042|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706043|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706044|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706045|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706046|NCT01817777|O2|Outcome|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706047|NCT01817777|O1|Outcome|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706048|NCT01817777|E2|Reported Event|Large Pack Metformin|Each participant received a large pack of MTF for an individualized dose depending on their diabetes treatment needs. The large pack consisted of one month’s supply of metformin.
706049|NCT01817777|E1|Reported Event|Small Pack Metformin|Each participant received a small pack of MTF for an individualized dose depending on their diabetes treatment needs. The small packs were available at each site in the following doses of MTF: 500 milligrams (mg), 850 mg, and 1000 mg. Participants on MTF twice daily received one small pack at each visit (sufficient for 5 days of treatment). Participants on MTF three times daily received two small packs at each visit (sufficient for 6 days of treatment).
706050|NCT01817764|B3|Baseline|Total|Total of all reporting groups
706051|NCT01817764|B2|Baseline|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
706052|NCT01817764|B1|Baseline|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
706053|NCT01817764|P2|Participant Flow|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
706054|NCT01817764|P1|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
706055|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
706056|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
706057|NCT01817764|O2|Outcome|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
706058|NCT01817764|O1|Outcome|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
706059|NCT01817764|E2|Reported Event|FSC 250/50 µg BID|Participants were randomized to fluticasone propionate/salmeterol (FSC) 250/50 µg twice-daily (BID) treatment in the morning and evening via a DPI and placebo in the morning via a separate DPI.
706060|NCT01817764|E1|Reported Event|UMEC/VI 62.5/25 µg QD|Participants were randomized to umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once-daily (QD) treatment in the morning via a dry powder inhaler (DPI) and placebo in the morning and evening via a separate DPI.
706230|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
706061|NCT01817725|B1|Baseline|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old."
706062|NCT01817725|P1|Participant Flow|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
706063|NCT01817725|O1|Outcome|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
706064|NCT01817725|O1|Outcome|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
706065|NCT01817725|E1|Reported Event|Engerix-B|"Engerix-B (20 μg/ml, GlaxoSmithKline) was administered at 0-2-4-6-8-10-12 months in dosage of 40μg for >20 years old and 20μg for < or =20 years old~HBV vaccine (Engerix B): Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage is 20μg in those <= 20 years old and 40μg in those > 20 years old."
706066|NCT01816685|B3|Baseline|Total|Total of all reporting groups
706067|NCT01816685|B2|Baseline|Routine Care|Routine care will be provided to the participant.
706068|NCT01816685|B1|Baseline|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
706069|NCT01816685|P2|Participant Flow|Routine Care|Routine care will be provided to the participant.
706070|NCT01816685|P1|Participant Flow|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
706071|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
706072|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
706073|NCT01816685|O2|Outcome|Routine Care|Routine care will be provided to the participant.
706074|NCT01816685|O1|Outcome|CPAP|Patients in the continuous positive airway pressure (CPAP) group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.
706075|NCT01816685|E2|Reported Event|Routine Care|Routine care will be provided to the participant.
706076|NCT01816685|E1|Reported Event|CPAP|"Patients in the CPAP group will be instructed to wear an autotitrating positive airway pressure (APAP) device any time they sleep prior to surgery and on postoperative days 0, 1, and 2.~CPAP"
706077|NCT01816477|B3|Baseline|Total|Total of all reporting groups
706078|NCT01816477|B2|Baseline|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
706079|NCT01816477|B1|Baseline|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
706080|NCT01816477|P2|Participant Flow|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
706081|NCT01816477|P1|Participant Flow|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
706082|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
706083|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
706084|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
706085|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
706086|NCT01816477|O2|Outcome|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
706087|NCT01816477|O1|Outcome|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
706088|NCT01816477|E2|Reported Event|ON-Q Soaker Catheter System|ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5” catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia.
706089|NCT01816477|E1|Reported Event|Thoracic Epidural|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
706090|NCT01816451|B4|Baseline|Total|Total of all reporting groups
706091|NCT01816451|B3|Baseline|Control|The control group did not do the running training program. Control did their normal physical activities.
706092|NCT01816451|B2|Baseline|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706093|NCT01816451|B1|Baseline|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706094|NCT01816451|P3|Participant Flow|Control|The control group did not do the running training program. Control did their normal physical activities.
706095|NCT01816451|P2|Participant Flow|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706096|NCT01816451|P1|Participant Flow|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706097|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706098|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706099|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706100|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706101|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706102|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706103|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706104|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706105|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706106|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706107|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706171|NCT01815918|O1|Outcome|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706108|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706109|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706110|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706111|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706112|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706113|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706604|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706114|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706115|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706116|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706117|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706118|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706119|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706120|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706121|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706122|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706123|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706124|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706125|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706126|NCT01816451|O3|Outcome|Control|The control group did not do the running training program. Control did their normal physical activities.
706127|NCT01816451|O2|Outcome|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine.The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706128|NCT01816451|O1|Outcome|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax-maximal heart rate (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706129|NCT01816451|E3|Reported Event|Control|The control group did not do the running training program. Control did their normal physical activities.
706130|NCT01816451|E2|Reported Event|Continuous|The running training for continuous group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The continuous group ran at an intensity of ~87%HRVO2peak/HRmax.
706131|NCT01816451|E1|Reported Event|Interval|The running training for interval group were performed on a treadmill for a period of 14 weeks, with a frequency of three times a week, lasting 20-minutes per session thus completing 46 sessions of training. The intensity and volume of training both were adapted according to the recommendations of the American College of Sports Medicine. The interval training group intensities ranged between 84-87% HRVO2peak/HRmax (vigorous intensity), 88-93%HRVO2peak/HRmax (near maximum intensity) and 94-99% HRVO2peak/HRmax (maximum intensity).
706132|NCT01816295|B3|Baseline|Total|Total of all reporting groups
706133|NCT01816295|B2|Baseline|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706134|NCT01816295|B1|Baseline|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706135|NCT01816295|P2|Participant Flow|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706136|NCT01816295|P1|Participant Flow|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706137|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706138|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706139|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706140|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706141|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706142|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706143|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706144|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706145|NCT01816295|O2|Outcome|Testosterone Solution|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period. Optional OLE period starting at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706146|NCT01816295|O1|Outcome|Placebo Solution|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period. In optional open label extension (OLE) period, 60 milligram (mg) testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 24 weeks.
706147|NCT01816295|E3|Reported Event|Testosterone Solution - OLE|Sixty mg testosterone solution applied topically to axillae once daily at 60 mg/day with possible down/up titration (30 – 120 mg/day) for 24 weeks in optional OLE period.
706148|NCT01816295|E2|Reported Event|Testosterone Solution - Double Blind|Sixty mg testosterone solution applied topically to axillae once daily with possible down/up titration (30 – 120 mg/day) for 12 week double-blind treatment period.
706149|NCT01816295|E1|Reported Event|Placebo Solution - Double Blind|Placebo solution applied topically to axillae once daily for 12 week double-blind treatment period.
706150|NCT01816243|B1|Baseline|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
706151|NCT01816243|P1|Participant Flow|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
706152|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
706182|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706153|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
706154|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
706155|NCT01816243|O1|Outcome|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
706156|NCT01816243|E1|Reported Event|Transdermal Therapeutic System (TTS) - Fentanyl|Transdermal Therapeutic System (TTS) - fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS was calculated based on each participant’s opioid requirement. Patches were usually replaced every 72 hours. Doses were escalated in steps of 25 mcg/hr, if pain cannot be controlled. 90 milligram per day (mg/day) of oral morphine was allowed as supplementary analgesic. The study duration was 30 days after first patch application.
706157|NCT01815918|B3|Baseline|Total|Total of all reporting groups
706158|NCT01815918|B2|Baseline|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706159|NCT01815918|B1|Baseline|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706160|NCT01815918|P2|Participant Flow|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706161|NCT01815918|P1|Participant Flow|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706162|NCT01815918|O2|Outcome|Treatment|
706163|NCT01815918|O1|Outcome|Placebo|
706164|NCT01815918|O2|Outcome|Treatment|
706165|NCT01815918|O1|Outcome|Placebo|
706166|NCT01815918|O2|Outcome|Treatment|Data was not collected
706167|NCT01815918|O1|Outcome|Placebo|Data was not collected
706168|NCT01815918|O2|Outcome|Treatment|
706169|NCT01815918|O1|Outcome|Placebo|
706170|NCT01815918|O2|Outcome|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706227|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
706172|NCT01815918|E2|Reported Event|Treatment|"Patients receive 3 100 mg of hydrocortisone: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.~Hydrocortisone: Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706173|NCT01815918|E1|Reported Event|Placebo|"Patients receive a saline placebo before surgery, 8 hours after the first dose and 16 hours after the first dose.~Placebo: Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose."
706174|NCT01815840|B3|Baseline|Total|Total of all reporting groups
706175|NCT01815840|B2|Baseline|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706176|NCT01815840|B1|Baseline|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706177|NCT01815840|P2|Participant Flow|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706178|NCT01815840|P1|Participant Flow|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706179|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706180|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706181|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706479|NCT01813890|B4|Baseline|Total|Total of all reporting groups
706183|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706184|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706185|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706186|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706187|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706188|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706189|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706190|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706191|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706192|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706193|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706194|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706195|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706196|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706197|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706198|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706228|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
706199|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706200|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706201|NCT01815840|O2|Outcome|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706202|NCT01815840|O1|Outcome|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706203|NCT01815840|E2|Reported Event|Vismodegib Induction Followed by Intermittent Schedule|Vismodegib beginning with 24 weeks induction followed by intermittent schedule 8 weeks placebo, 8 weeks vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706204|NCT01815840|E1|Reported Event|Vismodegib Intermittent Schedule|Vismodegib intermittent schedule of 12 weeks vismodegib followed by 8 weeks placebo, repeated 3 times with a final course of vismodegib (total 72 weeks), followed by 52 weeks treatment-free follow up
706205|NCT01815736|B3|Baseline|Total|Total of all reporting groups
706206|NCT01815736|B2|Baseline|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706207|NCT01815736|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706208|NCT01815736|P2|Participant Flow|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF)-containing regimen E/C/F/TDF (Stribild®); efavirenz (EFV)/FTC/TDF (Atripla®); ritonavir (RTV)-boosted atazanavir (ATV)+FTC/TDF; or cobicistat (COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706480|NCT01813890|B3|Baseline|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706209|NCT01815736|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) FDC tablet administered once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706210|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706211|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706212|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706213|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706214|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706215|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706216|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706217|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706218|NCT01815736|O2|Outcome|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706219|NCT01815736|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706220|NCT01815736|E2|Reported Event|Stay on Baseline Treatment Regimen (SBR)|Participants stayed on their baseline FTC/TDF-containing regimen (E/C/F/TDF; EFV/FTC/TDF; RTV-boosted ATV+FTC/TDF; or COBI-boosted ATV+FTC/TDF) administered according to prescribing information for up to 96 weeks in the Randomized Phase, with the option to switch to E/C/F/TAF in the Extension Phase.
706221|NCT01815736|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily for up to 96 weeks in the Randomized Phase, with the option to continue E/C/F/TAF in the Extension Phase.
706222|NCT01815671|B3|Baseline|Total|Total of all reporting groups
706223|NCT01815671|B2|Baseline|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
706224|NCT01815671|B1|Baseline|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
706225|NCT01815671|P2|Participant Flow|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
706226|NCT01815671|P1|Participant Flow|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
706231|NCT01815671|O2|Outcome|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
706232|NCT01815671|O1|Outcome|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
706233|NCT01815671|E2|Reported Event|Lateral Tilt Down|Subjects randomized to receive colonoscopy in the lateral tilt down position
706234|NCT01815671|E1|Reported Event|Lateral Horizontal|Subjects randomized to receive colonoscopy in the lateral horizontal position
706235|NCT01815099|B1|Baseline|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
706236|NCT01815099|P1|Participant Flow|rTMS Treatment|This was an open trial. All participants received active rTMS
706237|NCT01815099|O2|Outcome|Post rTMS Treatment|Assessment After Completing rTMS
706238|NCT01815099|O1|Outcome|Pre rTMS Treatment|Assessment before beginning rTMS treatment
706239|NCT01815099|E1|Reported Event|rTMS Treatment|rTMS Treatment: will entail twice weekly rTMS sessions for 5 weeks.
706240|NCT01815008|B1|Baseline|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
706241|NCT01815008|P1|Participant Flow|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
706242|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
706243|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
706244|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Note: The 2nd week of the study was not performed as we could not find low risk population in our cohort who could be given both anti-platelets without increased estimated risk of bleeding."
706245|NCT01815008|O1|Outcome|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
706246|NCT01815008|E1|Reported Event|Clopidogrel|"Clopidogrel 75 mg daily by mouth for 1 week then Clopidogrel 75 mg daily with aspirin 81 mg daily~Clopidogrel: Clopidogrel 75 mg daily~Aspirin: Aspirin 81 mg daily"
706247|NCT01814878|B3|Baseline|Total|Total of all reporting groups
706248|NCT01814878|B2|Baseline|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706249|NCT01814878|B1|Baseline|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706250|NCT01814878|P2|Participant Flow|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706251|NCT01814878|P1|Participant Flow|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706252|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706253|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706254|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706255|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706256|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706257|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706258|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706297|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706298|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706299|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706259|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706260|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706261|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706262|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706263|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706264|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706265|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706481|NCT01813890|B2|Baseline|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706266|NCT01814878|O2|Outcome|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706267|NCT01814878|O1|Outcome|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706268|NCT01814878|E2|Reported Event|Tramadol HCl/Acetaminophen IR|Participants received 2 oral tablets of IR tramadol HCl (37.5 mg)/acetaminophen (325 mg) and 2 tablets of placebo matched to ER tramadol HCl/acetaminophen at 0, 12, 24 and 36 hours, and 2 tablets of IR tramadol HCl/acetaminophen at 6, 18, 30 and 42 hours.
706269|NCT01814878|E1|Reported Event|Tramadol Hydrochloride (HCl)/Acetaminophen ER|Participants received 2 oral tablets of extended-release (ER) tramadol HCl (75 milligram [mg])/acetaminophen (650 mg) and 2 tablets of placebo matched to immediate-release (IR) tramadol HCl/acetaminophen orally every 12 hours up to 36 hours, and 2 tablets of placebo matched to IR tramadol HCl/acetaminophen every 6 hours up to 42 hours.
706270|NCT01814800|B1|Baseline|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706271|NCT01814800|P1|Participant Flow|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg IV infusion Frequency: Every 3 or 4 weeks~Initial dose selection based on prior IGIV regimen, doses adjusted during study to maintain trough Immunoglobulin G (IgG) concentration of 500 mg/dL or greater according to investigator decision."
706272|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706273|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706274|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706275|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706276|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706277|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706278|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706279|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706280|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706281|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706282|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706283|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706284|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706285|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706286|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706287|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706288|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706289|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706290|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706291|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706292|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706293|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706294|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706295|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706296|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706304|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706305|NCT01814800|O1|Outcome|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706306|NCT01814800|E1|Reported Event|RI-002 Treatment|"Drug: RI-002 Dose: 300-800 mg/kg infusion~RI-002"
706307|NCT01814787|B3|Baseline|Total|Total of all reporting groups
706308|NCT01814787|B2|Baseline|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
706309|NCT01814787|B1|Baseline|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.~CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system."
706310|NCT01814787|P2|Participant Flow|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
706311|NCT01814787|P1|Participant Flow|CHICA Type 2 Diabetes Module|"Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.~CHICA Type 2 Diabetes Module: Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system. If the child's BMI > 85th percentile, a prompt will appear on the provider worksheet asking the clinician"
706312|NCT01814787|O2|Outcome|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
706313|NCT01814787|O1|Outcome|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
706314|NCT01814787|E2|Reported Event|Usual Care|Those patients who are assigned to the control group will have the CHICA system but will NOT be cared for using the CHICA Type 2 Diabetes Module. The CHICA system will notify the physician of the child’s BMI percentile on the physician worksheet. However, the CHICA system will not ask for any additional information related to risk factors for type 2 diabetes on the pre-screening form, no advice will be provided to the physician on the physician worksheet, nor will just-in-time documents or automated reminder calls be made available. Identification of patients at risk for type 2 diabetes and care of those patients will occur through routine practices for that clinic.
706315|NCT01814787|E1|Reported Event|CHICA Type 2 Diabetes Module|Children treated at the two intervention clinic sites will have be treated using the CHICA system AND will be provided access to the newly developed CHICA Type 2 Diabetes Module. The CHICA Type 2 Diabetes Module will assist pediatricians in identification of those children 10 years of age or older who are at increased risk for type 2 diabetes, it will provide pediatric physicians guidelines to screen for type 2 diabetes, and it will coordinate the diagnosis and long-term management of the condition.
706316|NCT01814774|B1|Baseline|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706317|NCT01814774|P1|Participant Flow|All Participants|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) and Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706318|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706319|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706320|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706637|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
706321|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706322|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706323|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706324|NCT01814774|O2|Outcome|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706325|NCT01814774|O1|Outcome|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706326|NCT01814774|E2|Reported Event|Xeomin®|Retrospective chart review of doses of Xeomin® (incobotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706327|NCT01814774|E1|Reported Event|BOTOX®|Retrospective chart review of doses of BOTOX® (onabotulinumtoxinA) used as standard of care in clinical practice. No treatment (intervention) was administered.
706328|NCT01814761|B3|Baseline|Total|Total of all reporting groups
706329|NCT01814761|B2|Baseline|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706330|NCT01814761|B1|Baseline|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706331|NCT01814761|P2|Participant Flow|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706332|NCT01814761|P1|Participant Flow|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706333|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706334|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706335|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706336|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706337|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706338|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706339|NCT01814761|O2|Outcome|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706340|NCT01814761|O1|Outcome|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706341|NCT01814761|E2|Reported Event|Pts With POAG or OH (Switched Monotherapy)|Patients previously on another monotherapy treatment with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706342|NCT01814761|E1|Reported Event|Pts With POAG or OH (Previously Treatment Naive)|Previously treatment naïve patients with Primary Open-Angle Glaucoma (POAG) or Ocular Hypertension (OH) who require treatment with bimatoprost 0.01% (Lumigan® 0.01%).
706343|NCT01814748|B3|Baseline|Total|Total of all reporting groups
706344|NCT01814748|B2|Baseline|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706345|NCT01814748|B1|Baseline|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706346|NCT01814748|P2|Participant Flow|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706347|NCT01814748|P1|Participant Flow|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706348|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706349|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706350|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706351|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706390|NCT01814696|B1|Baseline|Control|Subjects will continue to receive usual medical care from their doctor(s).
706352|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706353|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706354|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706355|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706356|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706357|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706358|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706359|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706360|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706361|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706362|NCT01814748|O2|Outcome|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706363|NCT01814748|O1|Outcome|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706364|NCT01814748|E2|Reported Event|Placebo|Placebo to omarigliptin, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706365|NCT01814748|E1|Reported Event|Omarigliptin 25 mg|Omarigliptin 25 mg, once weekly, for 24 weeks. Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
706366|NCT01814722|B4|Baseline|Total|Total of all reporting groups
706367|NCT01814722|B3|Baseline|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
706368|NCT01814722|B2|Baseline|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
706369|NCT01814722|B1|Baseline|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
706370|NCT01814722|P3|Participant Flow|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
706371|NCT01814722|P2|Participant Flow|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
706372|NCT01814722|P1|Participant Flow|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
706373|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
706374|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
706375|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
706376|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
706377|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
706378|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
706379|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
706380|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
706381|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
706382|NCT01814722|O3|Outcome|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
706383|NCT01814722|O2|Outcome|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
706384|NCT01814722|O1|Outcome|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
706385|NCT01814722|E3|Reported Event|PI + 2 NRTIs|Participants were treated with two NRTIs and a protease inhibitor (PI).
706386|NCT01814722|E2|Reported Event|NNRTI + 2 NRTIs|Participants were treated with two NRTIs and a non-nucleoside reverse transcriptase inhibitor (NNRTI).
706387|NCT01814722|E1|Reported Event|Raltegravir + 2 NRTIs|Participants were treated with raltegravir (an integrase inhibitor), and two nucleoside reverse transcriptase inhibitors (NRTIs)
706388|NCT01814696|B3|Baseline|Total|Total of all reporting groups
706389|NCT01814696|B2|Baseline|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706515|NCT01813721|O1|Outcome|At or Above Investigator Threshold|
706391|NCT01814696|P2|Participant Flow|Intervention|"Subjects will continue to receive usual medical care from their doctor(s).~Intervention: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706392|NCT01814696|P1|Participant Flow|Control|"Subjects will continue to receive usual medical care from their doctor(s).~Subjects will follow their normal medication management routine."
706393|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706394|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
706395|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706396|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
706397|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706398|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
706399|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706400|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
706401|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706402|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
706403|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706404|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
706405|NCT01814696|O2|Outcome|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706406|NCT01814696|O1|Outcome|Control|Subjects will continue to receive usual medical care from their doctor(s).
706407|NCT01814696|E2|Reported Event|Intervention|"Subjects will continue to receive usual medical care from their doctor(s). Subjects will use the MedSentry System and electronic pillbox, to manage their medications.~MedSentry System: Subjects will use the MedSentry System and electronic pillbox, to manage their medications."
706408|NCT01814696|E1|Reported Event|Control|Subjects will continue to receive usual medical care from their doctor(s).
706409|NCT01814670|B1|Baseline|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706410|NCT01814670|P1|Participant Flow|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706411|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706412|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706413|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706414|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706415|NCT01814670|O1|Outcome|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706416|NCT01814670|E1|Reported Event|Botulinum Toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
706417|NCT01814553|B3|Baseline|Total|Total of all reporting groups
706418|NCT01814553|B2|Baseline|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706419|NCT01814553|B1|Baseline|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706420|NCT01814553|P2|Participant Flow|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706421|NCT01814553|P1|Participant Flow|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706422|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706423|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706424|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706482|NCT01813890|B1|Baseline|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706425|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706426|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706427|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706428|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706429|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706430|NCT01814553|O2|Outcome|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706431|NCT01814553|O1|Outcome|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706516|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
706517|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
706518|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
706519|NCT01813721|O1|Outcome|Breast Cancer|
706520|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
706521|NCT01813721|O3|Outcome|Private Center|
706522|NCT01813721|O2|Outcome|General Hospital|
706432|NCT01814553|E2|Reported Event|Afatinib 40 mg + Loperamide Prophylactic (Cohort 2)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and 2 tablets of loperamide 2 mg daily (i.e., 4 mg daily) starting on Course 1 Day 1. If any diarrhea was experienced (CTCAE Grade 1) by subjects, 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours. Subjects who experienced no diarrhea during Course 1 were allowed to reduce the loperamide dose to 2 mg daily and subjects who experienced no diarrhea during the first two courses discontinued daily prophylactic loperamide at the end of Course 2.
706433|NCT01814553|E1|Reported Event|Afatinib 40 mg + Loperamide (Cohort 1)|Subjects were orally administered with the starting dose of Afatinib Film-coated tablets 40 mg once daily - with possible dose reductions to 30 mg and 20 mg and if any diarrhea was experienced Common Terminology Criteria for Adverse Events (CTCAE Grade 1), 2 tablets of loperamide 2 mg were to be taken immediately, followed by 1 tablet of loperamide 2 mg with every subsequent loose bowel movement until bowel movements ceased for 12 hours.
706434|NCT01814397|B1|Baseline|Women Starting Aromatase Inhibitor (AI) Therapy|There is only a single cohort. Postmenopausal women with estrogen receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
706435|NCT01814397|P1|Participant Flow|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with hormone receptor positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
706436|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
706483|NCT01813890|P3|Participant Flow|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706605|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
706437|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
706438|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
706439|NCT01814397|O1|Outcome|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
706440|NCT01814397|E1|Reported Event|Women Starting AI Therapy|There is only a single cohort. Postmenopausal women with ER positive breast cancer who are starting treatment with anastrozole 1 mg daily, letrozole 2.5 mg daily, or exemestane 25 mg daily. Choice of therapy is at the discretion of the treating physician.
706441|NCT01814332|B3|Baseline|Total|Total of all reporting groups
706442|NCT01814332|B2|Baseline|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
706443|NCT01814332|B1|Baseline|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
706444|NCT01814332|P2|Participant Flow|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
706445|NCT01814332|P1|Participant Flow|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
706446|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
706447|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
706448|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
706449|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
706450|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
706451|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
706452|NCT01814332|O2|Outcome|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
706453|NCT01814332|O1|Outcome|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
706454|NCT01814332|E2|Reported Event|Placebo|"Placebo compound treatment for comparison with IP~Placebo: Placebo compound treatment for comparison with IP"
706455|NCT01814332|E1|Reported Event|GSK561679|"GSK561679, oral administration, 350mg/day, 6 week administration~GSK561679: GSK561679, oral administration, 350mg/day, 6 week administration"
706456|NCT01814241|B1|Baseline|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
706457|NCT01814241|P1|Participant Flow|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
706458|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
706459|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
706460|NCT01814241|O1|Outcome|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
706461|NCT01814241|E1|Reported Event|Open Label Peanut OIT|Open label orally ingested peanut flour with maintenance dose of 1450mg
706462|NCT01814137|B3|Baseline|Total|Total of all reporting groups
706523|NCT01813721|O1|Outcome|University Hospital|
706524|NCT01813721|O2|Outcome|> 10 Years|
706525|NCT01813721|O1|Outcome|≤ 10 Years|
706526|NCT01813721|O2|Outcome|Hematologist|
706527|NCT01813721|O1|Outcome|Medical Oncologist|
706463|NCT01814137|B2|Baseline|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706464|NCT01814137|B1|Baseline|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706484|NCT01813890|P2|Participant Flow|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706485|NCT01813890|P1|Participant Flow|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706465|NCT01814137|P2|Participant Flow|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706466|NCT01814137|P1|Participant Flow|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706467|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706468|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706469|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706528|NCT01813721|O4|Outcome|France|
706529|NCT01813721|O3|Outcome|Romania|
706530|NCT01813721|O2|Outcome|Greece|
706531|NCT01813721|O1|Outcome|Poland|
706532|NCT01813721|O2|Outcome|General Hospital|
706533|NCT01813721|O1|Outcome|University Hospital|
706534|NCT01813721|O2|Outcome|> 10 Years|
706535|NCT01813721|O1|Outcome|≤ 10 Years|
706470|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706471|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706472|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706473|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706474|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706475|NCT01814137|O2|Outcome|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706476|NCT01814137|O1|Outcome|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706536|NCT01813721|O1|Outcome|Medical Oncologist|
706537|NCT01813721|O4|Outcome|Small Cell Lung Cancer|
706538|NCT01813721|O3|Outcome|Non-Hodgkin's Lymphoma|
706539|NCT01813721|O2|Outcome|Non-small Cell Lung Cancer|
706540|NCT01813721|O1|Outcome|Breast Cancer|
706541|NCT01813721|O4|Outcome|Comprehensive Cancer Center|
706542|NCT01813721|O3|Outcome|Private Center|
706477|NCT01814137|E2|Reported Event|IDegAsp BID + IAsp OD|Subjects randomised to insulin degludec/insulin aspart (IDegAsp) twice daily (BID) + insulin aspart (IAsp) once daily (OD) , at the discretion of the investigator, started the doses of IDegAsp at week 26 in trial NN5401-3941 with breakfast and main evening meal and added 4 units of IAsp at lunch. IDegAsp was administered subcutaneously (s.c.) by injection in the thigh, the upper arm (deltoid area) or the abdominal wall. The chosen area of injection had to be the same throughout the trial, with rotation within a given region recommended. IAsp was injected s.c. with the main meal OD, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed due to intercurrent illness. Titration (self-titration) of both IDegAsp and IAsp was done once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator's discretion. IAsp dose reduction had to be done based on the investigator's discretion.
706478|NCT01814137|E1|Reported Event|IDeg OD + IAsp TID|Subjects randomised to insulin degludec (IDeg) OD + IAsp thrice daily (TID) were, at the discretion of the investigator, to start with 70% of the total daily dose of IDegAsp taken at Week 26 in trial NN5401-3941 as IDeg OD and 30% as IAsp divided into 3 doses. IDeg was administered s.c. by injection in the thigh, the upper arm (deltoid area) or the abdominal wall and the chosen area of injection had to be the same throughout the trial. Rotation of injection sites within a given region was recommended. The OD injection time could be changed from day to day. IAsp was injected s.c. with the main meals TID, preferably into the abdominal wall in accordance with local labelling. Additional doses of IAsp were only allowed, if needed. Titration (self-titration) of IDeg and IAsp was performed once weekly. Titration of IAsp could also be done based on carbohydrate counting but at the investigator’s discretion. IAsp dose reduction had to be done based on the investigator’s discretion.
706487|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706488|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706489|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706490|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706491|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706492|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706493|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706494|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706495|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706496|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706497|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706498|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706499|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706500|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706501|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706502|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706503|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706504|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706505|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706506|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706507|NCT01813890|O3|Outcome|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706508|NCT01813890|O2|Outcome|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706509|NCT01813890|O1|Outcome|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706510|NCT01813890|E3|Reported Event|Tapentadol IR 75 mg|Tapentadol 75 mg IR tablet administered orally, every 4 to 6 hours for 3 days.
706511|NCT01813890|E2|Reported Event|Tapentadol IR 50 mg|Tapentadol 50 milligram (mg) immediate release (IR) tablet administered orally, every 4 to 6 hours for 3 days.
706512|NCT01813890|E1|Reported Event|Placebo|Placebo matched to tapentadol tablet administered orally,every 4 to 6 hours for 3 days.
706513|NCT01813721|B1|Baseline|Primary Analysis Set|
706514|NCT01813721|P1|Participant Flow|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
706564|NCT01813721|E1|Reported Event|All Enrolled Patients|Participants with cancer who were planning to receive standard dose chemotherapy regimens with a documented intermediate risk (10% to 20%) of febrile neutropenia (FN).
706565|NCT01813019|B3|Baseline|Total|Total of all reporting groups
706566|NCT01813019|B2|Baseline|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
706567|NCT01813019|B1|Baseline|Placebo|Matching Placebo b.i.d. dosing
706568|NCT01813019|P2|Participant Flow|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
706569|NCT01813019|P1|Participant Flow|Placebo|Matching Placebo b.i.d. dosing
706570|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
706571|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
706572|NCT01813019|O2|Outcome|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
706573|NCT01813019|O1|Outcome|Placebo|Matching Placebo b.i.d. dosing
706574|NCT01813019|E2|Reported Event|AFQ056|AFQ056 b.i.d up-titration of 50mg,100mg, 150mg and 200 mg for 4 weeks then AFQ056 200mg b.i.d for 12 weeks and then a down-titration of AFQ056 100mg, 50mg and 25mg b.i.d for 3 weeks
706575|NCT01813019|E1|Reported Event|Placebo|Matching Placebo b.i.d. dosing
706576|NCT01812837|B4|Baseline|Total|Total of all reporting groups
706577|NCT01812837|B3|Baseline|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706578|NCT01812837|B2|Baseline|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706657|NCT01812655|E3|Reported Event|UC Provided by the Nurses|
706579|NCT01812837|B1|Baseline|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706580|NCT01812837|P3|Participant Flow|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706581|NCT01812837|P2|Participant Flow|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706582|NCT01812837|P1|Participant Flow|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706583|NCT01812837|O3|Outcome|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706584|NCT01812837|O2|Outcome|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706585|NCT01812837|O1|Outcome|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706586|NCT01812837|E3|Reported Event|60 Minute Microneedle Pretreatment Incubation|"60 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706634|NCT01812681|P1|Participant Flow|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
706635|NCT01812681|O2|Outcome|Normal Vitamin D|The premature infants with normal vitamin D level
706636|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
706587|NCT01812837|E2|Reported Event|40 Minute Microneedle Pretreatment Incubation|"40 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706588|NCT01812837|E1|Reported Event|20 Minute Microneedle Pretreatment Incubation|"20 min microneedle pretreatment incubation vs standard 60 min incubation (split-face)~Microneedle: The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.~Aminolevulinic Acid: Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA~Blue light: Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)"
706589|NCT01812707|B5|Baseline|Total|Total of all reporting groups
706590|NCT01812707|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706591|NCT01812707|B3|Baseline|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706592|NCT01812707|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706593|NCT01812707|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
706594|NCT01812707|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706595|NCT01812707|P3|Participant Flow|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706596|NCT01812707|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706597|NCT01812707|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
706598|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706599|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706600|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706601|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12 weeks in combination with atorvastatin stable dose.
706602|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706606|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706607|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706608|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706609|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
706610|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706611|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706612|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706613|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
706614|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706615|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706616|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706617|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
706618|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706619|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706620|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706621|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
706622|NCT01812707|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706623|NCT01812707|O3|Outcome|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706624|NCT01812707|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706625|NCT01812707|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
706626|NCT01812707|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706627|NCT01812707|E3|Reported Event|Alirocumab 75 mg Q2W|Alirocumab 75 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706628|NCT01812707|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
706629|NCT01812707|E1|Reported Event|Placebo|Placebo Q2W for 12 weeks in combination with atorvastatin stable dose.
706630|NCT01812681|B3|Baseline|Total|Total of all reporting groups
706631|NCT01812681|B2|Baseline|Normal Vitamin D|The premature infants with normal vitamin D level
706632|NCT01812681|B1|Baseline|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
706633|NCT01812681|P2|Participant Flow|Normal Vitamin D|The premature infants with normal vitamin D level
706638|NCT01812681|O1|Outcome|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
706639|NCT01812681|E2|Reported Event|Normal Vitamin D|The premature infants with normal vitamin D level
706640|NCT01812681|E1|Reported Event|Low Vitamin D Level|The premature infants with low cord blood vitamin D level
706641|NCT01812655|B4|Baseline|Total|Total of all reporting groups
706642|NCT01812655|B3|Baseline|Standard Care Provided by the Nurses|
706643|NCT01812655|B2|Baseline|Passive Distraction|watching a movie
706644|NCT01812655|B1|Baseline|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
706645|NCT01812655|P3|Participant Flow|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
706646|NCT01812655|P2|Participant Flow|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
706647|NCT01812655|P1|Participant Flow|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
706648|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
706649|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
706650|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
706651|NCT01812655|O3|Outcome|SC Provided by the Nurses|Nurses provided their usual, standard care throughout the entire burn wound care, such as talking with the patients. Mean time for the intervention use was 49.0 minutes.
706652|NCT01812655|O2|Outcome|Passive Distraction|Patients watched a movie, Cloudy with a Chance of Meatballs, throughout their burn wound care to offer passive distraction from wound care pain. Mean time for the intervention use was 31.6 minutes.
706653|NCT01812655|O1|Outcome|Virtual Reality|Patients were distracted from their burn wound care pain throughout their entire burn wound care procedure using an interactive virtual reality program designed for burn patients. Mean time for the intervention was 31.6 minutes.
706654|NCT01812655|O3|Outcome|Standard Care Provided by the Nurses|
706655|NCT01812655|O2|Outcome|Passive Distraction|watching a movie
706656|NCT01812655|O1|Outcome|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
706659|NCT01812655|E1|Reported Event|Virtual Reality|Virtual reality using a software program designed for burn patients during burn wound care
706660|NCT01812473|B3|Baseline|Total|Total of all reporting groups
706661|NCT01812473|B2|Baseline|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
706662|NCT01812473|B1|Baseline|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
706663|NCT01812473|P2|Participant Flow|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
706664|NCT01812473|P1|Participant Flow|Patients Admitted to the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
706665|NCT01812473|O2|Outcome|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
706666|NCT01812473|O1|Outcome|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
706667|NCT01812473|E2|Reported Event|Patients Admitted to the ICU Treated With Voriconazole|Patients admitted to the Intensive Care Unit, treated with voriconazole are included in this study. Voriconazole protein binding will be determined and the correlation with albumin plasma concentrations will be evaluated.
706668|NCT01812473|E1|Reported Event|Patients Admitted Tot the ICU Not Treated With Voriconazole|"Patients admitted to the intensive Care Unit, with varying levels of plasma albumin concentrations during admission.~Plasma from this patients will be spiked in vitro with different voriconazole concentrations to investigate the influence of low albumine concentrations in plasma on voriconazole protein binding characteristics."
706669|NCT01812044|B4|Baseline|Total|Total of all reporting groups
706670|NCT01812044|B3|Baseline|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
707028|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706671|NCT01812044|B2|Baseline|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706672|NCT01812044|B1|Baseline|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706673|NCT01812044|P3|Participant Flow|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706674|NCT01812044|P2|Participant Flow|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706675|NCT01812044|P1|Participant Flow|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706676|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706677|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706678|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706716|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
706679|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706680|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706681|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706682|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706683|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706684|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706685|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706686|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706687|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706735|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
706688|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706689|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706690|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706691|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706692|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706693|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706694|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706695|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706797|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706696|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706697|NCT01812044|O3|Outcome|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706698|NCT01812044|O2|Outcome|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706699|NCT01812044|O1|Outcome|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706700|NCT01812044|E3|Reported Event|Topical Control and Subtenons Control|"Group 3 (topical control and subtenons control): 0.5 cc of topical Hypromellose 0.3% gel applied topically to each surgical wound and 0.5 cc of NS administered via a cannula subtenons through each surgical wound at end of surgery~topical control - 0.5 cc of Hypromellose 0.3% gel~subtenons control - 0.5 cc of Normal Saline"
706701|NCT01812044|E2|Reported Event|Topical Anesthetic and Subtenons Control|"Group 2 (topical anesthetic and subtenons control): 0.5 cc of lidocaine 3.5% ophthalmic gel applied topically to each surgical wound and 0.5 cc of normal saline (NS) administered via a cannula subtenons through each surgical wound at end of surgery~topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel~subtenons control - 0.5 cc of Normal Saline"
706702|NCT01812044|E1|Reported Event|Subtenons Anesthetic and Topical Control|"Group 1 (subtenons anesthetic and topical control): 0.5 cc of local anesthetic (preservative-free bupivacaine 0.75%) administered via a cannula subtenons through each surgical wound with 0.5 cc of Hypromellose 0.3% gel applied topically to each surgical wound at end of surgery~subtenons anesthetic - preservative-free bupivacaine 0.75%~topical control - 0.5 cc of Hypromellose 0.3% gel"
706703|NCT01811953|B7|Baseline|Total|Total of all reporting groups
706704|NCT01811953|B6|Baseline|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706705|NCT01811953|B5|Baseline|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706706|NCT01811953|B4|Baseline|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706771|NCT01811680|O1|Outcome|Supervised Treadmill Training|Supervised treadmill training on variable sensing treadmill.
706707|NCT01811953|B3|Baseline|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706708|NCT01811953|B2|Baseline|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706709|NCT01811953|B1|Baseline|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706710|NCT01811953|P6|Participant Flow|Low Dose Emp: Emp+Met / Emp/Met|"free dose combination tablets under fed conditions first; then fixed-dose-combination tablet under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706711|NCT01811953|P5|Participant Flow|Low Dose Emp: Emp/Met / Emp+Met|"fixed-dose-combination tablet under fed conditions first; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706712|NCT01811953|P4|Participant Flow|Emp+Met Fed / Emp/Met Fed / Emp+Met Fasted / Emp/Met Fasted|"free dose combination tablets under fed conditions first; then FDC tablet under fed conditions; then free dose combination tablets under fasted conditions; then fixed-dose-combination (FDC) tablet under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706713|NCT01811953|P3|Participant Flow|Emp+Met Fasted / Emp/Met Fasted / Emp+Met Fed / Emp/Met Fed|"free dose combination tablets under fasted conditions first; then fixed-dose-combination (FDC) tablet under fasted conditions; then free dose combination tablets under fed conditions; then FDC tablet under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706714|NCT01811953|P2|Participant Flow|Emp/Met Fed / Emp+Met Fed / Emp/Met Fasted / Emp+Met Fasted|"fixed-dose-combination (FDC) tablet under fed conditions first; then free dose combination tablets under fed conditions; then FDC tablet under fasted conditions; then free dose combination tablets under fasted conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706715|NCT01811953|P1|Participant Flow|Emp/Met Fasted / Emp+Met Fasted / Emp/Met Fed / Emp+Met Fed|"fixed-dose-combination (FDC) tablet under fasted conditions first; then free dose combination tablets under fasted conditions; then FDC tablet under fed conditions; then free dose combination tablets under fed conditions~Empagliflozin (Emp): 12.5 mg; Metformin (Met): 1000 mg (oral with 240 ml water)"
706717|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
706718|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706719|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706720|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706721|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706722|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
706723|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
706724|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706725|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706726|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706727|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706728|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
706729|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
706730|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706731|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706732|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706733|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706734|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
706825|NCT01811472|B4|Baseline|Total|Total of all reporting groups
706736|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706737|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706738|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706739|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706740|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
706741|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
706742|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706743|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706744|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706745|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706746|NCT01811953|O6|Outcome|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
706747|NCT01811953|O5|Outcome|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
706748|NCT01811953|O4|Outcome|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706749|NCT01811953|O3|Outcome|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706750|NCT01811953|O2|Outcome|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706751|NCT01811953|O1|Outcome|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706798|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706752|NCT01811953|E6|Reported Event|6 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: low dose of Empagliflozin oral administration~Metformin: oral administration"
706753|NCT01811953|E5|Reported Event|5 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: low dose of Empagliflozin"
706754|NCT01811953|E4|Reported Event|4 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fed conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706755|NCT01811953|E3|Reported Event|3 Empagliflozin + Metformin (R)|"tablets, oral with 240 ml water under fasted conditions~Empagliflozin: medium dose oral administration~Metformin: oral administration"
706756|NCT01811953|E2|Reported Event|2 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fed conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706757|NCT01811953|E1|Reported Event|1 Empagliflozin/Metformin (T)|"fixed-dose-combination tablet, oral with 240 ml water under fasted conditions~Empagliflozin/Metformin: medium dose of Empagliflozin oral administration"
706758|NCT01811706|B1|Baseline|All Study Participants|
706759|NCT01811706|P2|Participant Flow|Placebo, Then Dalfampridine|"Participant first receive Placebo tablet orally every 12 hours, for a 4 weeks period. After a washout period of 2 weeks, they then receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
706760|NCT01811706|P1|Participant Flow|Dalfampridine and Then Placebo|"Participant first receive Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks. After a washout period of 2 weeks, they then receive Placebo tablet orally every 12 hours, for a 4 weeks period.~Dalfampridine: Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period~Placebo: Placebo will be administered orally every 12 hours, for a 4 week period."
706761|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
706762|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
706763|NCT01811706|O2|Outcome|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
706764|NCT01811706|O1|Outcome|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
706765|NCT01811706|O2|Outcome|Placebo|Participant who received Placebo orally every 12 hours for a 4 week period.
706766|NCT01811706|O1|Outcome|Dalfampridine|Participant who received Dalfampridine at an oral dose of 10mg every 12 hours for 4 weeks period.
706767|NCT01811706|E2|Reported Event|Placebo|Participant received Placebo orally every 12 hours for a 4 week period.
706768|NCT01811706|E1|Reported Event|Dalfampridine|Participant received Dalfampridine at an oral dose of 10mg every 12 hours, for 4 weeks period.
706769|NCT01811680|B1|Baseline|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
706770|NCT01811680|P1|Participant Flow|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
706772|NCT01811680|O1|Outcome|Supervised Treadmill Training|"Supervised treadmill training on variable sensing treadmill.~Variable Speed and Sensing Treadmill: open label study on variable speed and sending treadmill training for hemiplegic gait training."
706773|NCT01811680|E1|Reported Event|Supervised Treadmill Training|Research Intervention: Supervised treadmill training on variable sensing treadmill.
706774|NCT01811563|B3|Baseline|Total|Total of all reporting groups
706775|NCT01811563|B2|Baseline|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706776|NCT01811563|B1|Baseline|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706777|NCT01811563|P2|Participant Flow|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706778|NCT01811563|P1|Participant Flow|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706779|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706780|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706781|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706782|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706783|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706784|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706785|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706786|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706787|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706788|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706789|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706790|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706791|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706792|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706793|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706794|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706795|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706796|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706799|NCT01811563|O2|Outcome|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706800|NCT01811563|O1|Outcome|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706801|NCT01811563|E2|Reported Event|Zimmer|"Subjects will be receiving a Zimmer NexGen total knee replacement~Zimmer"
706802|NCT01811563|E1|Reported Event|Stryker|"Subjects will be receiving the Stryker Triathlon total knee replacement~Stryker"
706803|NCT01811485|B4|Baseline|Total|Total of all reporting groups
706804|NCT01811485|B3|Baseline|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
706805|NCT01811485|B2|Baseline|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
706806|NCT01811485|B1|Baseline|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
706807|NCT01811485|P3|Participant Flow|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
706808|NCT01811485|P2|Participant Flow|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
706809|NCT01811485|P1|Participant Flow|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
706810|NCT01811485|O3|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
706811|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
706812|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
706813|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
706814|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
706815|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
706816|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
706817|NCT01811485|O2|Outcome|LMF237 50/500 mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
706818|NCT01811485|O1|Outcome|LMF237 50/250 mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
706819|NCT01811485|O2|Outcome|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
706820|NCT01811485|O1|Outcome|Pooled LMF237|All patients who took LMF237 50/250 mg or LMF237 50/500 mg twice daily for 14 weeks were pooled together as reporting group.
706821|NCT01811485|E4|Reported Event|Placebo|Patients took matching placebo of LMF237 (vildagliptin 50 mg) twice daily for 14 weeks
706822|NCT01811485|E3|Reported Event|LMF237 50/500mg|Patients took LMF237 50/500 mg (with a starting dose of LMF 237 50/250 mg for 2 weeks) twice daily for 14 weeks
706823|NCT01811485|E2|Reported Event|LMF237 50/250mg|Patients took LMF237 50/250 mg twice daily for 14 weeks
706824|NCT01811485|E1|Reported Event|POOLED LMF237|All patients who has received LMF237
706826|NCT01811472|B3|Baseline|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706827|NCT01811472|B2|Baseline|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706828|NCT01811472|B1|Baseline|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706829|NCT01811472|P3|Participant Flow|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706830|NCT01811472|P2|Participant Flow|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706831|NCT01811472|P1|Participant Flow|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706832|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706833|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706834|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706835|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706836|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706837|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706838|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706839|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706840|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706841|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706878|NCT01811303|P2|Participant Flow|Treatment, Treatment, Placebo, Placebo|The subjects receive treatment in the first two interventions
706879|NCT01811303|P1|Participant Flow|Placebo, Placebo, Treatment, Treatment|The subjects receive placebo in the first two interventions.
706842|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706843|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706844|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706845|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706846|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706847|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706848|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706849|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706897|NCT01811186|B1|Baseline|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706850|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706851|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706852|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706853|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706854|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706855|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706856|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706857|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706858|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706859|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706860|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706861|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706862|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706863|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706864|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706865|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706898|NCT01811186|P2|Participant Flow|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706899|NCT01811186|P1|Participant Flow|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706866|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706867|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706868|NCT01811472|O3|Outcome|Pradigastat (LCQ908) 10mg/20mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706869|NCT01811472|O2|Outcome|Pradigastat (LCQ908) 5mg/10mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706870|NCT01811472|O1|Outcome|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706871|NCT01811472|E4|Reported Event|Pooled Pradigastat (LCQ908)|This arm included all patients randomized to pradigastat (LCQ908) 5mg/10 mg and pradigastat (LCQ908)10mg/20 mg
706872|NCT01811472|E3|Reported Event|Pradigastat (LCQ908) 10mg/20 mg|Patients, randomized to pradigastat 10/20 mg, initially began with pradigastat (LCQ908) 10 mg once daily and then were up-titrated, if pradigastat (LCQ908) 10 mg once daily was tolerated, to pradigastat 20 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706873|NCT01811472|E2|Reported Event|Pradigastat (LCQ908) 5mg /10 mg|Patients, randomized to pradigastat 5/10 mg, initially began with pradigastat (LCQ908) 5 mg once daily and then were up-titrated, if pradigastat (LCQ908) 5 mg once daily was tolerated, to pradigastat 10 mg once daily at Week 2. Total treatment duration was 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706874|NCT01811472|E1|Reported Event|Placebo|Patients randomized to Placebo arm, received matching placebo to 5 mg, 10 mg and 20 mg pradigstat (LCQ908) once daily for 24 weeks. Each patient was to receive 3 tablets a day. All patients were required to remain on their American Heart Association (AHA) diet for the entire duration of the study.
706875|NCT01811303|B1|Baseline|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water vs placebo.
706876|NCT01811303|P4|Participant Flow|Treatment, Placebo, Treatment, Placebo|The subjects receive placebo or treatment in each intervention alternatively, starting with treatment.
706877|NCT01811303|P3|Participant Flow|Placebo, Treatment, Placebo, Treatment|The subjects receive placebo or treatment in each intervention alternatively, starting with placebo.
706880|NCT01811303|O2|Outcome|Control|Determination of glucose Cmax over the Baseline of the control: sucrose 50 g + 200 ml water. Blood glucose concentration expressed in mmol/l.
706881|NCT01811303|O1|Outcome|D-fagomine|Determination of glucose Cmax over the Baseline of the treatment: sucrose 50 g + 200 ml water + 40 mg D-fagomine. Blood glucose concentration expressed in mmol/l.
706882|NCT01811303|O2|Outcome|Change D-fagomine/Control AUC at 120 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 120 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
706883|NCT01811303|O1|Outcome|Change D-fagomine/Control AUC at 60 Min|Determine the relative change in the Glycaemic response between sucrose with D-fagomine and sucrose without D-fagomine in the first 60 minutes (postprandial). Calculated on incremental Area Under the Curve (AUC) from the individual glucose measurements in capillary blood, and evaluated by repeated measures ANOVA.
706884|NCT01811303|E2|Reported Event|Placebo - Control (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g sucrose in 200 ml water (without d-fagomine)
706885|NCT01811303|E1|Reported Event|D-fagomine (All Study Participants)|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose containing 40 mg D-fagomine, in 200 ml water.
706886|NCT01811238|B1|Baseline|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706887|NCT01811238|P1|Participant Flow|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706888|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706889|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706890|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706891|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706892|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/naloxone: Targin 5mg, 10mg, 20mg up to 40mg b.i.d"
706893|NCT01811238|O1|Outcome|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706894|NCT01811238|E1|Reported Event|Oxycodone/Naloxone|"Single-arm study~Oxycodone/Naloxone: 8 weeks treatment with Oxycodone/Naloxone"
706895|NCT01811186|B3|Baseline|Total|Total of all reporting groups
706896|NCT01811186|B2|Baseline|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706900|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706901|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706902|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706903|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
706904|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706905|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
706906|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706907|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
706908|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706909|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
706910|NCT01811186|O2|Outcome|Start Oxycodone/Naloxone 5/2.5mg b.i.d.|Start oxycodone/naloxone 5/2.5mg b.i.d->10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706911|NCT01811186|O1|Outcome|Start Oxycodone/Naloxone 10/5mg b.i.d.|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d
706912|NCT01811186|E2|Reported Event|Start Oxycodone/Naloxone 5/2.5mg b.i.d|Start oxycodone/naloxone 5/2.5mg b.i.d titration-> 10/5mg b.i.d.->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706913|NCT01811186|E1|Reported Event|Start Oxycodone/Naloxone 10/5mg b.i.d|Start oxycodone/naloxone 10/5mg b.i.d. titration->20/10mg b.i.d.->30/15mg b.i.d->40/20mg b.i.d.
706914|NCT01810952|B3|Baseline|Total|Total of all reporting groups
706915|NCT01810952|B2|Baseline|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
706942|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
706943|NCT01810939|E3|Reported Event|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
706944|NCT01810939|E2|Reported Event|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
707063|NCT01810263|E1|Reported Event|High Protein Supplement|high protein supplement given
706916|NCT01810952|B1|Baseline|Glargine/Lispro Insulin Arm|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
706917|NCT01810952|P2|Participant Flow|Glargine/Lispro/NPH Insulin|"The basal and prandial doses of glargine and lispro insulin were similar to those in the Glargine/Lispro Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
706918|NCT01810952|P1|Participant Flow|Glargine/Lispro Insulin|"The Glargine/Lispro Arm included 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
706919|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
706920|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
706921|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|
706922|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|
706923|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Insulin (units)/kg body weight
706924|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Insulin (units)/kg body weight
706925|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|Last Full Day of Protocol
706926|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|Last Full Day of Protocol
706927|NCT01810952|O2|Outcome|Glargine/Lispro/NPH Insulin Arm|"Basal and meal coverage for G/L/N Arm is similar to that in the GL Arm. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro/NPH insulin: The G/L/N Protocol will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all the insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent will be given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose will be 0.4 units/kg per day."
706998|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706928|NCT01810952|O1|Outcome|Glargine/Lispro Insulin Arm|"The G/L Arm will include 0.2 unit/kg/day as insulin glargine daily if the dose is between 40-80 units, or twice daily if the dose is less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent will be divided between 3 meals. The maximum starting coverage dose will be 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose will be increased by 10% if the fasting glucose value is 141-200 mg/dL and by 20% if the fasting glucose value is more than 200 mg/dL, and decreased by 10% if the fasting FSG is 70-89 mg/dL and by 20% if the fasting FSG is less than 70 mg/dL."
706929|NCT01810952|E2|Reported Event|Glargine/Lispro/NPH Insulin Arm|"The basal and prandial doses of glargine and lispro were similar to those in the G/L/N Protocol. A coverage dose of 0.1 unit/kg/day of NPH for each 10 mg of prednisone or its equivalent was given twice daily with the administration of the glucocorticoid. The maximum starting coverage dose was 0.4 units/kg per day."
706930|NCT01810952|E1|Reported Event|Glargine/Lispro Insulin Arm|"The G/L Arm received 0.2 unit/kg/day as insulin glargine daily if the dose was between 40-80 units, or twice daily if the dose was less than 40 or more than 80 units; plus 0.2 unit/kg/day as lispro divided between three meals for all insulin-naïve patients. A coverage dose of 0.1 unit/kg/day of lispro for each 10 mg of prednisone or its equivalent was divided between 3 meals. The maximum starting coverage dose was 0.4 units/kg per day.~Glargine/Lispro insulin: In both protocols glargine dose was increased by 10% if the fasting glucose value was 141-200 mg/dL and by 20% if the fasting glucose value was more than 200 mg/dL, and decreased by 10% if the fasting FSG was 70-89 mg/dL and by 20% if the fasting FSG was less than 70 mg/dL."
706931|NCT01810939|B1|Baseline|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
706932|NCT01810939|P3|Participant Flow|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
706933|NCT01810939|P2|Participant Flow|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
706934|NCT01810939|P1|Participant Flow|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
706935|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
706936|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
706937|NCT01810939|O1|Outcome|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks. The dose of patiromer could be titrated based on participant's serum potassium response.
706938|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
706939|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
706940|NCT01810939|O2|Outcome|Part B Patiromer|Participants continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks.
706941|NCT01810939|O1|Outcome|Part B Placebo|Participants were administered placebo orally twice a day for 8 weeks.
706945|NCT01810939|E1|Reported Event|Part A Patiromer|Participants were administered patiromer starting dose of 8.4 g or 16.8 g daily as a divided dose twice a day, orally, for 4 weeks.
706946|NCT01810783|B1|Baseline|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
706947|NCT01810783|P1|Participant Flow|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
706948|NCT01810783|O1|Outcome|Brexpiprazole|Brexpiprazole: 1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
706949|NCT01810783|E1|Reported Event|Brexpiprazole|210 were enrolled, only 209 patients were treated with brexpiprazole
706950|NCT01810692|B3|Baseline|Total|Total of all reporting groups
706951|NCT01810692|B2|Baseline|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
706952|NCT01810692|B1|Baseline|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
706953|NCT01810692|P2|Participant Flow|Hirobriz/Onbrez/Oslif Breezhaler|Patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
706954|NCT01810692|P1|Participant Flow|Spiriva Respimat|Patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
706955|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
706956|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
706957|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
706958|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
706959|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
706960|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
706961|NCT01810692|O2|Outcome|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
706962|NCT01810692|O1|Outcome|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
706963|NCT01810692|E2|Reported Event|Hirobriz/Onbrez/Oslif Breezhaler|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Hirobriz Breezhaler, Onbrez Breezhaler or Oslif Breezhaler, 150µg / 300µg inhalation powder, once daily oral inhalation.
706964|NCT01810692|E1|Reported Event|Spiriva Respimat|Chronic Obstructive Pulmonary Disease (COPD) patients treated with Spiriva Respimat, 2.5 µg, 2 puffs once daily, oral inhalation.
706965|NCT01810666|B1|Baseline|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
706966|NCT01810666|P1|Participant Flow|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
706967|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
706968|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
706969|NCT01810666|O1|Outcome|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
706970|NCT01810666|E1|Reported Event|Rec. Factor VIII On-demand Followed by Prophylaxis|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
706972|NCT01810380|B3|Baseline|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706973|NCT01810380|B2|Baseline|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706974|NCT01810380|B1|Baseline|Placebo|Placebo: Once daily as tablets and capsules, orally
706975|NCT01810380|P3|Participant Flow|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706976|NCT01810380|P2|Participant Flow|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706977|NCT01810380|P1|Participant Flow|Placebo|Placebo: Once daily as tablets and capsules, orally
706978|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706979|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706980|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706981|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706982|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706983|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706984|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706985|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706986|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706987|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706988|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706989|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706990|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706991|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706992|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706993|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706994|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706995|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
706996|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
706997|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
706999|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707000|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707001|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707002|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707003|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707004|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707005|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707006|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707007|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707008|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707009|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707010|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707011|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707012|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707013|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707014|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707015|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707016|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707017|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707018|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707019|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707020|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707021|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707022|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707023|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707024|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707025|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707026|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707027|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707029|NCT01810380|O3|Outcome|Quetiapine Extended Release|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707030|NCT01810380|O2|Outcome|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707031|NCT01810380|O1|Outcome|Placebo|Placebo: Once daily as tablets and capsules, orally
707032|NCT01810380|E3|Reported Event|Quetiapine|"Active Reference~Quetiapine extended release: 400-800 mg/day, once daily, encapsulated tablets, orally"
707033|NCT01810380|E2|Reported Event|Brexpiprazole|Brexpiprazole: 2-4 mg/day, once daily, tablets, orally
707034|NCT01810380|E1|Reported Event|Placebo|Placebo: Once daily as tablets and capsules, orally
707035|NCT01810302|B3|Baseline|Total|Total of all reporting groups
707036|NCT01810302|B2|Baseline|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
707037|NCT01810302|B1|Baseline|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
707038|NCT01810302|P2|Participant Flow|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
707039|NCT01810302|P1|Participant Flow|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
707040|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
707041|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
707042|NCT01810302|O2|Outcome|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
707043|NCT01810302|O1|Outcome|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
707081|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
708758|NCT01800786|O2|Outcome|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
707044|NCT01810302|E2|Reported Event|Preservative-free Normal Saline|"Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.~Preservative-free normal saline: Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10."
707045|NCT01810302|E1|Reported Event|Nicardipine Hydrochloride|"Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.~Nicardipine hydrochloride: Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10."
707046|NCT01810289|B3|Baseline|Total|Total of all reporting groups
707047|NCT01810289|B2|Baseline|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707048|NCT01810289|B1|Baseline|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707049|NCT01810289|P2|Participant Flow|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707050|NCT01810289|P1|Participant Flow|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707051|NCT01810289|O2|Outcome|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707052|NCT01810289|O1|Outcome|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707053|NCT01810289|E2|Reported Event|Post-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707054|NCT01810289|E1|Reported Event|Pre-intervention|This study is stepped-wedge in design, so each clinic experienced a period of time before the intervention rolled out and then a time period after the intervention rolled out. Each clinic contributes time to both conditions.
707055|NCT01810263|B3|Baseline|Total|Total of all reporting groups
707056|NCT01810263|B2|Baseline|Control|no intervention
707057|NCT01810263|B1|Baseline|High Protein Supplement|high protein supplement given
707058|NCT01810263|P2|Participant Flow|Control|Patients in the both groups keep on routine diet in the hospital. No additional calories are provided.
707059|NCT01810263|P1|Participant Flow|High Protein Supplement|"Patients in the both groups keep on routine diet in the hospital All the patients in the High Protein Supplement group were provided additional calories of Nucare(High protein fluid diet, 200kcal/200ml/1 can. Dasang, Seoul, Korea) three times a day.~(As a result, additional calories are 600kcal a day)"
707060|NCT01810263|O2|Outcome|Control|no intervention
707061|NCT01810263|O1|Outcome|High Protein Supplement|high protein supplement given
707062|NCT01810263|E2|Reported Event|Control|no intervention
707064|NCT01810042|B1|Baseline|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
707065|NCT01810042|P1|Participant Flow|Ranibizumab|"Ranibizumab is injected monthly 3 times then pro re nata (PRN) to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
707066|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
707067|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
707068|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
707069|NCT01810042|O1|Outcome|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
707070|NCT01810042|E1|Reported Event|Ranibizumab|"Ranibizumab is injected monthly 3 times then PRN to 6 months.~intravitreal injection of ranibizumab: 0.5mg of ranibizumab is injected into the vitreous cavity through pars plana."
707071|NCT01809938|B1|Baseline|Entire Study Population|Includes all participants in this crossover trial
707072|NCT01809938|P2|Participant Flow|Tea With Milk First Then Black Tea|Effects on gastric emptying of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed then after a period of not less than 24 hours the effects of Black tea (300ml of tea without milk) were assessed.
707073|NCT01809938|P1|Participant Flow|Black Tea First, Then Tea With Milk|Effects on gastric emptying of Black tea (300ml of tea without milk) were assessed then after a period of not less than 24 hours the effects of Tea with Milk (250mls of tea with 50mls of full fat millk) were assessed
707074|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
707075|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
707076|NCT01809938|O2|Outcome|Tea With Milk|Tea with milk : 250ml of black tea with 50ml of full fat milk
707077|NCT01809938|O1|Outcome|Black Tea|Black tea : 300ml of tea without milk
707078|NCT01809938|E1|Reported Event|Entire Study Population|Includes all participants in this crossover trial
707079|NCT01809834|B1|Baseline|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707080|NCT01809834|P1|Participant Flow|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simulataneously~Etafilcon A~Stenfilcon A"
707082|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707083|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707084|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707085|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707086|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707087|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707088|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707089|NCT01809834|O1|Outcome|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707090|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707091|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707092|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707093|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707094|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707095|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707096|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707097|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707098|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707099|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707100|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707101|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707102|NCT01809834|O2|Outcome|Stenfilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707103|NCT01809834|O1|Outcome|Etafilcon A|"Each participant was randomized to wear the test lens in one eye and the control lens in the other simultaneously~Etafilcon A~Stenfilcon A"
707104|NCT01809834|E1|Reported Event|All Participants|"Each participant was randomized to wear the test lens in one eye and the control lens in the other~Etafilcon A~Stenfilcon A"
707105|NCT01809639|B3|Baseline|Total|Total of all reporting groups
707106|NCT01809639|B2|Baseline|Placebo|Placebo: Standard placebo for 5 days
707107|NCT01809639|B1|Baseline|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
707108|NCT01809639|P2|Participant Flow|Placebo|Placebo: Standard placebo for 5 days
707109|NCT01809639|P1|Participant Flow|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
707110|NCT01809639|O2|Outcome|Placebo|Placebo: Standard placebo for 5 days
707111|NCT01809639|O1|Outcome|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
707112|NCT01809639|E2|Reported Event|Placebo|Placebo: Standard placebo for 5 days
707113|NCT01809639|E1|Reported Event|Progesterone|"400mg of oral micronized progesterone (Prometrium®) on days one, two, and three then 200mg on days four and five~Progesterone"
707114|NCT01809327|B6|Baseline|Total|Total of all reporting groups
707115|NCT01809327|B5|Baseline|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707116|NCT01809327|B4|Baseline|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707117|NCT01809327|B3|Baseline|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707118|NCT01809327|B2|Baseline|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707119|NCT01809327|B1|Baseline|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707120|NCT01809327|P5|Participant Flow|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707121|NCT01809327|P4|Participant Flow|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707122|NCT01809327|P3|Participant Flow|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707123|NCT01809327|P2|Participant Flow|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707124|NCT01809327|P1|Participant Flow|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707125|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707126|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707127|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707128|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707129|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707130|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707131|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707132|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707133|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707134|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707135|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707136|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707137|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707138|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707139|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707140|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707141|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707187|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707188|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707142|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707143|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707144|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707145|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707146|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707147|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707148|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707149|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707150|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707151|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707152|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707153|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707220|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707221|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707154|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707155|NCT01809327|O5|Outcome|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707156|NCT01809327|O4|Outcome|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707157|NCT01809327|O3|Outcome|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707158|NCT01809327|O2|Outcome|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707159|NCT01809327|O1|Outcome|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707160|NCT01809327|E5|Reported Event|Canagliflozin 300 mg + Metformin XR|Participants received one 300 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707161|NCT01809327|E4|Reported Event|Canagliflozin 100 mg + Metformin XR|Participants received one 100 mg canagliflozin capsule with the evening meal and one matching placebo capsule before the morning meal plus metformin XR tablets (in doses titrated over 9 weeks) once daily with the evening meal for 26 weeks.
707162|NCT01809327|E3|Reported Event|Canagliflozin 300 mg|Participants received one 300 mg canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707163|NCT01809327|E2|Reported Event|Canagliflozin 100 Milligram (mg)|Participants received one 100 milligram (mg) canagliflozin capsule before the morning meal and one matching placebo capsule with the evening meal plus placebo tablets with the evening meal (to match the metformin XR tablets administered in other treatment arms) for 26 weeks.
707164|NCT01809327|E1|Reported Event|Metformin XR|Participants received metformin extended release (XR) tablets (in doses titrated over 9 weeks) once daily with the evening meal, plus one placebo capsule before the morning meal and one placebo capsule with the evening meal (to match the canagliflozin capsules administered in other treatment arms) for 26 weeks.
707165|NCT01809314|B1|Baseline|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
707166|NCT01809314|P1|Participant Flow|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
707167|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
707168|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
707169|NCT01809314|O1|Outcome|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
707170|NCT01809314|E1|Reported Event|NeoRecormon in Symptomatic Anemia|Participants with symptomatic anemia who received epoetin beta (NeoRecormon) according to standard of care and the Summary of Product Characteristics were observed for 4 months. Treatment was selected at the discretion of the prescriber prior to enrollment and not chosen by the Sponsor in this non-interventional study.
707171|NCT01809262|B1|Baseline|Study Total|Total number of patients treated in the study. This was a double-blind, 5-period crossover trial. Each of the 36 patients received placebo and 4 single doses of Olodaterol (Olo) (2 microgram (mcg), 5 mcg, 10 mcg, 20mcg) separated by a wash-out period of at least 14 days.
707172|NCT01809262|P10|Participant Flow|Olo 20mcg / Olo 10mcg / Placebo / Olo 5mcg / Olo 2mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, matching Placebo in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707173|NCT01809262|P9|Participant Flow|Olo 20mcg / Placebo / Olo 10mcg / Olo 2mcg / Olo 5mcg|Patients were administered Olodaterol 20 mcg qd in the first period, matching Placebo in the second period, Olodaterol 10 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707174|NCT01809262|P8|Participant Flow|Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 2 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
707175|NCT01809262|P7|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707176|NCT01809262|P6|Participant Flow|Olo 5mcg / Olo 10mcg / Olo 2mcg / Olo 20mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
707177|NCT01809262|P5|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707178|NCT01809262|P4|Participant Flow|Olo 2mcg / Placebo / Olo 5mcg / Olo 20mcg / Olo 10mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707179|NCT01809262|P3|Participant Flow|Olo 2mcg / Olo 5mcg / Placebo / Olo 10mcg / Olo 20mcg|Patients were administered Olodaterol 2 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707180|NCT01809262|P2|Participant Flow|Placebo / Olo 20mcg / Olo 2mcg / Olo 10mcg / Olo 5mcg|Patients were administered matching Placebo in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707181|NCT01809262|P1|Participant Flow|Placebo / Olo 2mcg / Olo 20mcg / Olo 5mcg / Olo 10mcg|Patients were administered matching Placebo in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
707182|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707183|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707184|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707185|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707186|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707192|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707193|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707194|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707195|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707196|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707197|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707198|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707199|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707200|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707201|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707202|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707203|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707204|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707205|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707206|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707207|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707208|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707209|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707210|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707211|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707212|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707213|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707214|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707215|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707216|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707217|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707218|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707219|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707222|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707223|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707224|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707225|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707226|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707227|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707228|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707229|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707230|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707231|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707232|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707233|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707234|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707235|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707236|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707237|NCT01809262|O5|Outcome|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707238|NCT01809262|O4|Outcome|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707239|NCT01809262|O3|Outcome|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707240|NCT01809262|O2|Outcome|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707241|NCT01809262|O1|Outcome|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707242|NCT01809262|E5|Reported Event|Olo 20 mcg|Single dose of Olodaterol 20 mcg delivered by the Respimat inhaler.
707243|NCT01809262|E4|Reported Event|Olo 10 mcg|Single dose of Olodaterol 10 mcg delivered by the Respimat inhaler.
707244|NCT01809262|E3|Reported Event|Olo 5 mcg|Single dose of Olodaterol 5mcg delivered by the Respimat inhaler.
707245|NCT01809262|E2|Reported Event|Olo 2 mcg|Single dose of Olodaterol 2 mcg delivered by the Respimat inhaler.
707246|NCT01809262|E1|Reported Event|Placebo|Single dose of matching placebo delivered by the Respimat inhaler.
707247|NCT01809197|B3|Baseline|Total|Total of all reporting groups
707248|NCT01809197|B2|Baseline|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
707249|NCT01809197|B1|Baseline|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
707250|NCT01809197|P2|Participant Flow|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
707369|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707251|NCT01809197|P1|Participant Flow|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
707252|NCT01809197|O2|Outcome|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
707253|NCT01809197|O1|Outcome|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
707254|NCT01809197|E2|Reported Event|Acuvue Oasys/Habitual MPS|Senofilcon A contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with habitual MPS lens care system
707255|NCT01809197|E1|Reported Event|Air Optix/OFPM|Lotrafilcon B contact lenses (sphere, toric and multifocal), worn on a daily wear basis for 30 days, with OPTI-FREE MPDS lens care system
707256|NCT01809106|B5|Baseline|Total|Total of all reporting groups
707257|NCT01809106|B4|Baseline|Fentanyl|Fentanyl: 25 microg/h
707258|NCT01809106|B3|Baseline|Buprenorphine|Buprenorphine: 35 microg/h
707259|NCT01809106|B2|Baseline|Oxycodone|Oxycodone: 40 mg /24 ore
707260|NCT01809106|B1|Baseline|Morphine|Morphine: 60 mg /24 ore
707261|NCT01809106|P4|Participant Flow|Fentanyl|Fentanyl: 25 microg/h
707262|NCT01809106|P3|Participant Flow|Buprenorphine|Buprenorphine: 35 microg/h
707263|NCT01809106|P2|Participant Flow|Oxycodone|Oxycodone: 40 mg /24 ore
707264|NCT01809106|P1|Participant Flow|Morphine|Morphine: 60 mg /24 ore
707265|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
707266|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
707267|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
707268|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
707269|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
707270|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
707271|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
707272|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
707273|NCT01809106|O4|Outcome|Fentanyl|Fentanyl: 25 microg/h
707274|NCT01809106|O3|Outcome|Buprenorphine|Buprenorphine: 35 microg/h
707275|NCT01809106|O2|Outcome|Oxycodone|Oxycodone: 40 mg /24 ore
707276|NCT01809106|O1|Outcome|Morphine|Morphine: 60 mg /24 ore
707277|NCT01809106|E4|Reported Event|Fentanyl|Fentanyl: 25 microg/h
707278|NCT01809106|E3|Reported Event|Buprenorphine|Buprenorphine: 35 microg/h
707279|NCT01809106|E2|Reported Event|Oxycodone|Oxycodone: 40 mg /24 ore
707280|NCT01809106|E1|Reported Event|Morphine|Morphine: 60 mg /24 ore
707281|NCT01809054|B3|Baseline|Total|Total of all reporting groups
707310|NCT01808950|E2|Reported Event|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
707282|NCT01809054|B2|Baseline|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
707283|NCT01809054|B1|Baseline|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
707284|NCT01809054|P2|Participant Flow|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
707285|NCT01809054|P1|Participant Flow|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
707286|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
707287|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
707288|NCT01809054|O2|Outcome|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
707289|NCT01809054|O1|Outcome|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
707290|NCT01809054|E2|Reported Event|Pneumatic Compression Stockings Arm|"Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.~Pneumatic compression stockings: Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)~Aspirin"
707291|NCT01809054|E1|Reported Event|Arixtra Arm|"Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks~Arixtra~Aspirin"
707292|NCT01808963|B1|Baseline|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
707293|NCT01808963|P1|Participant Flow|Study Group|Patients undergoing elective surgery requiring endotracheal intubation for anesthesia.
707294|NCT01808963|O1|Outcome|Study Group|Joules per minute
707295|NCT01808963|E1|Reported Event|Study Group|Respiratory Heat Loss Measured in Joules Per Minute
707296|NCT01808950|B4|Baseline|Total|Total of all reporting groups
707297|NCT01808950|B3|Baseline|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
707326|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707298|NCT01808950|B2|Baseline|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
707299|NCT01808950|B1|Baseline|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
707300|NCT01808950|P3|Participant Flow|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
707301|NCT01808950|P2|Participant Flow|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
707302|NCT01808950|P1|Participant Flow|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
707303|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C: shave biopsy of BCC followed by single 100mg dose"
707304|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
707305|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation"
707306|NCT01808950|O3|Outcome|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
707307|NCT01808950|O2|Outcome|0.06% Resiquimod Gel - B|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - B"
707308|NCT01808950|O1|Outcome|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
707309|NCT01808950|E3|Reported Event|0.06% Resiquimod Gel - C|"100 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~The BCC will be pretreated. A shave biopsy (curettage or scraping off the tissue in a broad, superficial, tangential way) will be performed~0.06% Resiquimod Gel - C"
707389|NCT01808547|B3|Baseline|Total|Total of all reporting groups
707311|NCT01808950|E1|Reported Event|0.06% Resiquimod Gel - A|"60 mg gel~Once daily prior to normal sleeping hours~5x within 1 week (Monday to Friday) for 4 weeks (at maximum) or until clinical manifestation of skin erosion/crust formation~0.06% Resiquimod Gel - A"
707312|NCT01808755|B1|Baseline|All Study Participamts|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
707313|NCT01808755|P2|Participant Flow|Trimethoprim/Sulfamethoxazole First, Then D Mannose|Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks
707314|NCT01808755|P1|Participant Flow|D Mannose First, Then Trimethoprim/Sulfamethoxazole|D Mannose 1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfametoxazole 80 mg + 400 mg twice a day; length of treatment: 5-7 days
707315|NCT01808755|O2|Outcome|Trimethoprim /Sulfamethoxazole First, Then D Mannose|trimethoprim/sulfametossazole 160/800 mg for 5-7 days then D Mannose 1 gr. every 8 hours for 2 weeks
707316|NCT01808755|O1|Outcome|D Mannose First, Then Trimethoprim /Sulfamethoxazole|1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks then Antibiotic : trimethoprim/sulfamethoxazole 160/800 mg; length of treatment: 5-7 days
707317|NCT01808755|E1|Reported Event|D Mannose Versus Antibiotic|"1 gr. every 8 hours for 2 weeks, subsequently 1 gr. every 12 hours for 22 weeks~D Mannose : D Mannose versus oral antibiotic~Antibiotic : length of treatment: 5-7 days"
707318|NCT01808651|B4|Baseline|Total|Total of all reporting groups
707319|NCT01808651|B3|Baseline|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707320|NCT01808651|B2|Baseline|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707321|NCT01808651|B1|Baseline|PLA/FLX (Placebo/Fluoxetine)|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707322|NCT01808651|P3|Participant Flow|FLX40/FLX|"Period 1: Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
707323|NCT01808651|P2|Participant Flow|FLX20/FLX|"Period 1: Participants randomized to fluoxetine 20 mg /day in Study B1Y-JE-HCLV and continued on fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation of fluoxetine."
707324|NCT01808651|P1|Participant Flow|PLA/FLX|"Period 1: Participants (Pts) randomized to placebo in Study B1Y-JE-HCLV transitioned to fluoxetine 20 to 40 mg capsules administered orally, once daily, for 52 weeks in Study B1Y-JE-HCLW.~Period 2: 2-week observation phase following discontinuation (DC'd) of fluoxetine."
707325|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707327|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707328|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707329|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707330|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707331|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707332|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707333|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707334|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707335|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707336|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707337|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707338|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707339|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707340|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707341|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707342|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707343|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707344|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707345|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707390|NCT01808547|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
707346|NCT01808651|O3|Outcome|FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707347|NCT01808651|O2|Outcome|FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707348|NCT01808651|O1|Outcome|PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707349|NCT01808651|E6|Reported Event|Study Period 2 Discontinued From FLX40/FLX|Participants in the FLX40/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
707350|NCT01808651|E5|Reported Event|Study Period 2 Discontinued From FLX20/FLX|Participants in the FLX20/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2.
707351|NCT01808651|E4|Reported Event|Study Period 2 Discontinued From PLA/FLX|Participants in the PLA/FLX group in Study Period 1, and discontinuing from fluoxetine in Study Period 2,
707352|NCT01808651|E3|Reported Event|Study Period 1 FLX40/FLX|Participants randomized to fluoxetine 40 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707353|NCT01808651|E2|Reported Event|Study Period 1 FLX20/FLX|Participants randomized to fluoxetine 20 mg/day in Study B1Y-JE-HCLV and continued on fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707354|NCT01808651|E1|Reported Event|Study Period 1 PLA/FLX|Participants randomized to placebo in Study B1Y-JE-HCLV and transitioned to fluoxetine (20-40 mg/day) in Study B1Y-JE-HCLW.
707355|NCT01808612|B4|Baseline|Total|Total of all reporting groups
707356|NCT01808612|B3|Baseline|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
707357|NCT01808612|B2|Baseline|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707358|NCT01808612|B1|Baseline|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707359|NCT01808612|P3|Participant Flow|Placebo|"Treatment Period: placebo (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
707360|NCT01808612|P2|Participant Flow|40 mg Fluoxetine|"Treatment Period: 40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
707361|NCT01808612|P1|Participant Flow|20 mg Fluoxetine|"Treatment Period: 20 milligrams (mg) fluoxetine (capsules) administered orally, once daily, for 6 weeks~Discontinuation Period: placebo (capsules) administered orally, once daily, for 2 weeks"
707362|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
707363|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707364|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707365|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
707366|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707367|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707370|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707371|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
707372|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707373|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707374|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
707375|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707376|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707377|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
707378|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707379|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707380|NCT01808612|O3|Outcome|Placebo|Placebo (capsules) administered orally, once daily, for 6 weeks
707381|NCT01808612|O2|Outcome|40 mg Fluoxetine|40 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707382|NCT01808612|O1|Outcome|20 mg Fluoxetine|20 mg fluoxetine (capsules) administered orally, once daily, for 6 weeks
707383|NCT01808612|E6|Reported Event|Placebo (Discontinuation From 40 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 40 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
707384|NCT01808612|E5|Reported Event|Placebo (Discontinuation From 20 mg Fluoxetine)|AEs which occurred during the Discontinuation Period for participants who received 20 mg fluoxetine during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
707385|NCT01808612|E4|Reported Event|Placebo (Discontinuation From Placebo)|AEs which occurred during the Discontinuation Period for participants who received placebo during the Treatment Period and who received placebo administered orally, once daily, for 2 weeks during the Discontinuation Period
707386|NCT01808612|E3|Reported Event|40 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 40 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
707387|NCT01808612|E2|Reported Event|20 mg Fluoxetine (Treatment Period)|AEs which occurred during the Treatment Period for participants who received 20 mg fluoxetine administered orally, once daily, for 6 weeks during the Treatment Period
707388|NCT01808612|E1|Reported Event|Placebo (Treatment Period)|Adverse events (AEs) which occurred during the Treatment Period for participants who received placebo administered orally, once daily, for 6 weeks during the Treatment Period
707391|NCT01808547|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
707392|NCT01808547|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
707393|NCT01808547|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
707394|NCT01808547|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
707395|NCT01808547|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
707396|NCT01808547|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
707397|NCT01808547|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
707398|NCT01808534|B1|Baseline|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707399|NCT01808534|P1|Participant Flow|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707400|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707401|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707402|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707403|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707404|NCT01808534|O1|Outcome|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707405|NCT01808534|E1|Reported Event|Treatment (Palifosfamide)|Patients receive palifosfamide IV over 30 minutes on days 1-3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
707406|NCT01808508|B4|Baseline|Total|Total of all reporting groups
707407|NCT01808508|B3|Baseline|Group 3 - No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group
707408|NCT01808508|B2|Baseline|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
707409|NCT01808508|B1|Baseline|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
707410|NCT01808508|P3|Participant Flow|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
709745|NCT01791725|E1|Reported Event|ELND005 BID|"ELND005 250 mg BID~ELND005"
707411|NCT01808508|P2|Participant Flow|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
707412|NCT01808508|P1|Participant Flow|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
707413|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
707414|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
707415|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
707416|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
707417|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
707418|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
707419|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
707420|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
707421|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
707422|NCT01808508|O3|Outcome|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
707423|NCT01808508|O2|Outcome|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
707424|NCT01808508|O1|Outcome|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
707425|NCT01808508|E3|Reported Event|Group 3- No Intervention|Group 3 are individuals with normal breathing during sleep who will not receive any intervention and will be used as a control group.
707426|NCT01808508|E2|Reported Event|Group 2-Sham Continuous Positive Airway Pressure (CPAP)|"Group 2 are individuals with OSAS who will receive sham or placebo continuous positive airway pressure (CPAP) for 4 months.~Sham or placebo continuous positive airway pressure: Sham or placebo CPAP is a machine used instead of therapeutic CPAP.~This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS."
707427|NCT01808508|E1|Reported Event|Group 1- Continuous Positive Airway Pressure (CPAP)|"Group 1 will receive therapeutic CPAP for 4 months.~Continuous positive airway pressure: Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open."
707428|NCT01808339|B1|Baseline|FF 100 µg AM/FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in either of the six sequences: ABC , ACB, BAC, BCA, CAB, or CBA. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI), during treatment B: participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI during treatment C: participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707429|NCT01808339|P6|Participant Flow|Placebo/FF 100 µg PM /FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence CBA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707602|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707603|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707430|NCT01808339|P5|Participant Flow|Placebo/FF 100 µg AM/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence CAB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707431|NCT01808339|P4|Participant Flow|FF 100 µg PM /Placebo/FF 100 µg AM|Participants received 3 treatments (A, B, and C) in sequence BCA. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707432|NCT01808339|P3|Participant Flow|FF 100 µg PM /FF 100 µg AM/Placebo|Participants received 3 treatments (A, B, and C) in sequence BAC. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707433|NCT01808339|P2|Participant Flow|FF 100 µg AM/Placebo/FF 100 µg PM|Participants received 3 treatments (A, B, and C) in sequence ACB. During treatment A participants received FF 100 µg in the AM at approximately 09:00 and received placebo in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI. During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707434|NCT01808339|P1|Participant Flow|FF 100 µg AM /FF 100 µg PM/Placebo|Participants received 3 treatments (A, B, and C) in sequence ABC. During treatment A participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI). During treatment B participants received placebo in the AM and FF 100 µg in the PM for 14 days (+/-2 days) via a DPI. During treatment C participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707435|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707518|NCT01808248|E1|Reported Event|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
707436|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707437|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707438|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707439|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707440|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707441|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707442|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707443|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707444|NCT01808339|O3|Outcome|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707445|NCT01808339|O2|Outcome|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707604|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707605|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707446|NCT01808339|O1|Outcome|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707447|NCT01808339|E3|Reported Event|Placebo|Participants received placebo via a DPI for 14 days (+/-2 days) in the AM and PM. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707448|NCT01808339|E2|Reported Event|FF 100 µg PM|Participants received placebo in the AM at approximately 09:00 and FF 100 µg in the PM at approximately 21:00 for 14 days (+/-2 days) via a DPI in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707449|NCT01808339|E1|Reported Event|FF 100 µg AM|Participants received fluticasone furoate (FF) 100 micrograms (100 µg) in the morning (AM) at approximately 09:00 and received placebo in the evening (PM) at approximately 21:00 for 14 days (+/-2 days) via a dry powder inhaler (DPI) in one of the three treatment periods. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
707450|NCT01808326|B1|Baseline|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707451|NCT01808326|P1|Participant Flow|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707488|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707519|NCT01808209|B3|Baseline|Total|Total of all reporting groups
709124|NCT01798264|E4|Reported Event|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
707452|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707453|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707454|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707501|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707606|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707455|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707456|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707457|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707458|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707489|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707576|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707459|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707460|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707461|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707462|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707463|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707464|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707465|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707490|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707577|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707466|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707467|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707468|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707469|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707470|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707471|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707472|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707491|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707578|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707473|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707474|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707475|NCT01808326|O1|Outcome|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707476|NCT01808326|E1|Reported Event|Chlorambucil 10 mg/m^2|Participants with previously untreated chronic lymphocytic leukemia (CLL) received chlorambucil 10 milligram (mg)/meter squared (m^2) orally on Days 1-7 of every 28-day cycle for a minimum of 3 cycles until best response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 84 and 168 days after the day of PDFU 1 (PDFU 85 and PDFU 169, respectively) to assess survival status, date of next CLL therapy, and type of therapy. In subsequent visits, the participant continued
707477|NCT01808313|B1|Baseline|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707478|NCT01808313|P1|Participant Flow|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707479|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707480|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707481|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707482|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707483|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707484|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707485|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707486|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707487|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707492|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707493|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707494|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707495|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707496|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707497|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707498|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707499|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707500|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707601|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707607|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707502|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707503|NCT01808313|O1|Outcome|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707504|NCT01808313|E1|Reported Event|Ambrisentan|Participants received one tablet of 5 milligrams (mg) ambrisentan (AMB) once daily (QD) for the first 12 Weeks. After 12 Weeks, the AMB dose was titrated to either one tablet of 5 mg QD or one tablet of 10 mg QD, as determined by the investigator for another 12 Weeks.
707505|NCT01808248|B3|Baseline|Total|Total of all reporting groups
707506|NCT01808248|B2|Baseline|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
707507|NCT01808248|B1|Baseline|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 hepatitis C virus (HCV) infection.
707508|NCT01808248|P1|Participant Flow|SOF+PEG+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + peginterferon alfa 2a (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
707509|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
707510|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
707511|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
707512|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
707513|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
707514|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
707515|NCT01808248|O1|Outcome|SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
707516|NCT01808248|O2|Outcome|Genotype 3|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
707517|NCT01808248|O1|Outcome|Genotype 2|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
707579|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707520|NCT01808209|B2|Baseline|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707521|NCT01808209|B1|Baseline|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707522|NCT01808209|P2|Participant Flow|Filcon II 3 Then Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
707523|NCT01808209|P1|Participant Flow|Stenfilcon A Then Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707524|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707525|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707526|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
707527|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707528|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
707529|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707530|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
707531|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
707532|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707533|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
707534|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair worn one week.
707535|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707536|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707537|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707538|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707539|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707540|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
707541|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707542|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707543|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses..
708303|NCT01802632|P2|Participant Flow|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
707544|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707545|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707546|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
707547|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707548|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707549|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
707550|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707551|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707552|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
707553|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
707554|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707555|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707556|NCT01808209|O1|Outcome|Habitual Lens|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each pair was worn one week.
707557|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707558|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707559|NCT01808209|O2|Outcome|Filcon II 3|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707560|NCT01808209|O1|Outcome|Stenfilcon A|All participants completing the study were habitual lens wearers. All participants wore both sets of study lenses. Participants were randomized to wear either pair of study lenses as a first pair and then crossed over to wear the alternate second pair of study lenses. Each worn one week.
707561|NCT01808209|O1|Outcome|Overall Study Group|All 59 subjects with habitual lens prior to dispense of study lenses.
707562|NCT01808209|E2|Reported Event|Filcon II 3|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
707563|NCT01808209|E1|Reported Event|Stenfilcon A|All participants completing the study wore both sets of study lenses.Participants were randomized to wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
707564|NCT01808092|B3|Baseline|Total|Total of all reporting groups
707565|NCT01808092|B2|Baseline|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707566|NCT01808092|B1|Baseline|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707567|NCT01808092|P2|Participant Flow|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707568|NCT01808092|P1|Participant Flow|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707569|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707570|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707571|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707572|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707573|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707574|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707575|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707580|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707581|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707582|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707583|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707584|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707585|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707586|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707587|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707588|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707589|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707590|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707591|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707592|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707593|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707594|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707595|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707596|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707597|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707598|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707599|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707600|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707608|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707609|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707610|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707611|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707612|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707613|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707614|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707615|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707616|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707617|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707618|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707619|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707620|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707621|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707622|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707623|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707624|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707625|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707626|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707627|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707628|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707629|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707630|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707631|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707632|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707633|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707634|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707635|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707636|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707637|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707638|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707639|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707640|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707641|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707642|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707643|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707644|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707645|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707646|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707647|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707648|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707649|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707650|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707651|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707652|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707653|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707654|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707655|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707656|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707657|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707658|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707659|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707660|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707661|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707662|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707663|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707664|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707665|NCT01808092|O2|Outcome|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707666|NCT01808092|O1|Outcome|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707667|NCT01808092|E2|Reported Event|Meropenem|meropenem 1000mg IV infused over 30 minutes plus CAZ-AVI placebo
707668|NCT01808092|E1|Reported Event|CAZ-AVI|2000mg ceftazidime / 500mg avibactam intravenous (IV) infused over 2 hours plus appropriate placebo to meropenem
707669|NCT01808066|B1|Baseline|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
707670|NCT01808066|P1|Participant Flow|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
707671|NCT01808066|O1|Outcome|Play Groundskeeper|"This study will employ design-based research models (Laurel, 2003) to the executive-functioning training game GroundsKeeper by CogCubed; we will assess the quality of digital designs for learning (Barab & Squire, 2004) using established qualitative data collection to analyze game play and player reaction over a three week period of time.~Groundskeeper: Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task."
707672|NCT01808066|E1|Reported Event|Treatment Group|21 participants with ADHD who underwent the intervention for 3 weeks, played for 20 minutes at a time at school.
707673|NCT01807949|B4|Baseline|Total|Total of all reporting groups
707674|NCT01807949|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
708673|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
707675|NCT01807949|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707676|NCT01807949|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707677|NCT01807949|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707678|NCT01807949|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707679|NCT01807949|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
707680|NCT01807949|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707681|NCT01807949|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707682|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707683|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707684|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707685|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707686|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707687|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707688|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707689|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707690|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707691|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707692|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707693|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707694|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707695|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707696|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707697|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707698|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707700|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707701|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707702|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707703|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707704|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707705|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707706|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707707|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707708|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707709|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707710|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707711|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707712|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707713|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707714|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707715|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707716|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707717|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707718|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707719|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707720|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707721|NCT01807949|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707722|NCT01807949|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707723|NCT01807949|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707724|NCT01807949|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707725|NCT01807949|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707726|NCT01807949|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707727|NCT01807923|B4|Baseline|Total|Total of all reporting groups
707728|NCT01807923|B3|Baseline|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707729|NCT01807923|B2|Baseline|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707730|NCT01807923|B1|Baseline|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707731|NCT01807923|P3|Participant Flow|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707732|NCT01807923|P2|Participant Flow|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 milligram (mg) plus IVA 250 mg fixed-dose combination (FDC) tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707733|NCT01807923|P1|Participant Flow|Placebo|Placebo matched to lumacaftor (LUM, VX-809) and ivacaftor (IVA, VX-770) tablet every 12 hours (q12h), up to Week 24.
707734|NCT01807923|O2|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707735|NCT01807923|O1|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707736|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707737|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707738|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707739|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707740|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707741|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707742|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707743|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707744|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707745|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707746|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707748|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707749|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707750|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707751|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707752|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707753|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707754|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707755|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707756|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707757|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707758|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707759|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707760|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707761|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707762|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707763|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707764|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707765|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707766|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707767|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707768|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707769|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707770|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707771|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707772|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707773|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707774|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707775|NCT01807923|O3|Outcome|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707776|NCT01807923|O2|Outcome|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707777|NCT01807923|O1|Outcome|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707778|NCT01807923|E3|Reported Event|LUM 400 mg q12h/ IVA 250 mg q12h|LUM 400 mg plus IVA 250 mg FDC tablet in the morning and in the evening, up to Week 24.
707779|NCT01807923|E2|Reported Event|LUM 600 mg qd/IVA 250 mg q12h|LUM 600 mg plus IVA 250 mg FDC tablet in the morning and IVA 250 mg film-coated tablet in the evening, up to Week 24.
707780|NCT01807923|E1|Reported Event|Placebo|Placebo matched to LUM and IVA tablet q12h, up to Week 24.
707781|NCT01807871|B3|Baseline|Total|Total of all reporting groups
707782|NCT01807871|B2|Baseline|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
707783|NCT01807871|B1|Baseline|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
707784|NCT01807871|P2|Participant Flow|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
707785|NCT01807871|P1|Participant Flow|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
707786|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
707787|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
707788|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
707789|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
707790|NCT01807871|O2|Outcome|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
707791|NCT01807871|O1|Outcome|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
707792|NCT01807871|E2|Reported Event|Nicotine Patch, Labeled Use|"Participants will discontinue using the nicotine patch when they resume smoking. This is the current FDA approved use of the nicotine patches.~nicotine patch, labeled use: nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling."
707793|NCT01807871|E1|Reported Event|Nicotine Patch, Experimental Use|"Participants will continue to use nicotine patch after they lapse and resume smoking as long as smoking is less than 75% of pre study levels.~nicotine patch, experimental use: nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch."
708674|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
707794|NCT01807624|B1|Baseline|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707795|NCT01807624|P1|Participant Flow|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707796|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707797|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707798|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707799|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707800|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707801|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707802|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707803|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707804|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707805|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707806|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707837|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707807|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707808|NCT01807624|O1|Outcome|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707809|NCT01807624|E1|Reported Event|Kovacaine Nasal Spray|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl"
707810|NCT01807455|B1|Baseline|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707811|NCT01807455|P1|Participant Flow|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707812|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707813|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707814|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707815|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707816|NCT01807455|O1|Outcome|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707817|NCT01807455|E1|Reported Event|Restylane Vital Lidocaine|Restylane Vital Lidocaine
707818|NCT01807234|B7|Baseline|Total|Total of all reporting groups
707819|NCT01807234|B6|Baseline|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
707820|NCT01807234|B5|Baseline|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
707821|NCT01807234|B4|Baseline|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
707822|NCT01807234|B3|Baseline|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
707823|NCT01807234|B2|Baseline|Ketorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
707824|NCT01807234|B1|Baseline|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
707838|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707839|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707825|NCT01807234|P6|Participant Flow|Placebo Then Sumatriptan Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
707826|NCT01807234|P5|Participant Flow|Placebo Then Ketorolac Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
707827|NCT01807234|P4|Participant Flow|Sumatriptan Then Placebo Then Ketorolac|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril."
707828|NCT01807234|P3|Participant Flow|Sumatriptan Then Ketorolac Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 2: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
707851|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707852|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707877|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707829|NCT01807234|P2|Participant Flow|Kerorolac Then Placebo Then Sumatriptan|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril.~Attack 3: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril."
707830|NCT01807234|P1|Participant Flow|Ketorolac Then Sumatriptan Then Placebo|"Participants were randomized for three attacks. For each treated attack, participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.~Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo~Attack 1: Ketorolac: Single dose of Ketorolac spray 31.5 kg, one spray in each nostril for acute migraine attack (Treatment A), placebo spray (Treatment B) in one nostril.~Attack 2: Sumatriptan: Placebo spray (treatment A) in one nostril, 20 mg single dose of Sumatriptan spray (Treatment B) into one nostril.~Attack 3: Placebo: Placebo spray (Treatment A) in each nostril, Placebo Spray (Treatment B) in each nostril."
707831|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707832|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707833|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707834|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707835|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707836|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707840|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707841|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707842|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707843|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707844|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707845|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707846|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707847|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707848|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707849|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707850|NCT01807234|O2|Outcome|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
708138|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
707853|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707854|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707855|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707856|NCT01807234|O2|Outcome|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707857|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707858|NCT01807234|O3|Outcome|Ketorolac Placebo/ Sumatriptan Placebo|"Single dose Ketorolac placebo, single dose Sumatriptan placebo~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707859|NCT01807234|O2|Outcome|Sumatriptan/ Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707860|NCT01807234|O1|Outcome|Ketorolac/ Placebo|"Ketorolac 31.5 mg single dose nasal spray and Placebo~Ketorolac: Single dose of Ketorolac nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: Ketorolac placebo one spray in each nostril and Sumatriptan placebo one nasal spray."
707861|NCT01807234|E3|Reported Event|SRIX Placebo/Sumatriptan Placebo|"single dose SPRIX placebo, single dose Sumatriptan placebo~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~The most common adverse event for placebo were unusual taste (mild in 4%, moderate in 2%), nausea (4%), rash (4%), fatigue (4%), burning of the nose (2%), dizziness (2%)."
707862|NCT01807234|E2|Reported Event|Sumatriptan/Placebo|"Sumatriptan 20 mg single dose nasal spray and placebo~Sumatriptan: Sumatriptan 20 mg one single dose of nasal spray for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~For those treated with sumatriptan NS the most common adverse events were unusual taste (mild in 24.5%, moderate in 12.2%, severe 4.1%), burning of the nose (mild in 6.1%, moderate in 2%), nausea (8%), burning of the throat (6%), nasal discomfort (6%), dizziness (4%), fatigue (4%) and rash (2%)."
707863|NCT01807234|E1|Reported Event|Sprix/Placebo|"Sprix 31.5 mg single dose nasal spray and Placebo~SPRIX: Single dose of Sprix nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.~Placebo: SPRIX placebo one spray in each nostril and Sumatriptan placebo one nasal spray.~The most common adverse events reported by participants treated with ketorolac NS were burning of nose, (mild in 25.5%, moderate in 19.6% and severe in 3.9%), unusual taste (mild in 2%, moderate in 5.9%, severe 2%), nasal discomfort (8%), burning of throat (6%), fatigue (4%), dizziness (4%), nausea (2%), rash (2%)."
707910|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707911|NCT01806857|O2|Outcome|Matching Placebo|
707912|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707913|NCT01806857|O2|Outcome|Matching Placebo|
707914|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707864|NCT01807156|B1|Baseline|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
707865|NCT01807156|P1|Participant Flow|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
707866|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
707867|NCT01807156|O1|Outcome|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
707868|NCT01807156|E1|Reported Event|Tivozanib|"Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study.~Tivozanib: Oral medication given daily. No placebo."
707869|NCT01807000|B1|Baseline|[14C] PRUCALOPRIDE SUCCINATE|
707870|NCT01807000|P1|Participant Flow|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707871|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707872|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707873|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707874|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707875|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707876|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707878|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707879|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707880|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707881|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707882|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707883|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707884|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707885|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707886|NCT01807000|O1|Outcome|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707887|NCT01807000|E1|Reported Event|[14C] PRUCALOPRIDE SUCCINATE|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
707888|NCT01806961|B1|Baseline|Clearance at End of Trial SP848-AK-1101|no trial medication during this follow-up trial
707889|NCT01806961|P1|Participant Flow|SP848-AK-1101|Patients from SP848-AK-1101 trial
707890|NCT01806961|O1|Outcome|Group 1|Patients from SP848-AK-1101 trial
707891|NCT01806961|E1|Reported Event|Group 1|Patients from SP848-AK-1101 trial
707892|NCT01806857|B1|Baseline|All Study Participants|
707893|NCT01806857|P2|Participant Flow|Matching Placebo Then Nuedexta|"Subjects in this arm will receive treatment with matching placebo first for 28 days (±3 days) and then crossed over to receive treatment with Nuedexta for 28 days (±3 days).~Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days~Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
707894|NCT01806857|P1|Participant Flow|Nuedexta Then Matching Placebo|"Subjects in this arm will receive treatment with Nuedexta first for 28 days (±3 days) and then crossed over to receive treatment with matching placebo for 28 days (±3 days).~Nuedexta: Nuedexta PO (by mouth) for 28 ± 3 days~Matching Placebo: matching placebo PO (by mouth) for 28 ± 3 days"
707895|NCT01806857|O2|Outcome|Matching Placebo|
707896|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707897|NCT01806857|O2|Outcome|Matching Placebo|
707898|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707899|NCT01806857|O2|Outcome|Matching Placebo|
707900|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707901|NCT01806857|O2|Outcome|Matching Placebo|
707902|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707903|NCT01806857|O2|Outcome|Matching Placebo|
707904|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707905|NCT01806857|O2|Outcome|Matching Placebo|
707906|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707907|NCT01806857|O2|Outcome|Matching Placebo|
707908|NCT01806857|O1|Outcome|Active Drug (Nuedexta)|
707909|NCT01806857|O2|Outcome|Matching Placebo|
707928|NCT01806857|E1|Reported Event|Active Drug (Neudexta)|Includes all subjects that took the active drug (Neudexta)
707929|NCT01806779|B3|Baseline|Total|Total of all reporting groups
707930|NCT01806779|B2|Baseline|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707931|NCT01806779|B1|Baseline|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707932|NCT01806779|P3|Participant Flow|Nicotine Patches Only|These subjects received nicotine patches at the first study visit but dropped out before randomization. 176 subjects attended the second study visit and provided side effects (SE) data. Two of these subjects dropped out during that visit (after providing SE data but prior to randomization). So, out of the initial 197 subjects receiving nicotine patches, 174 went on to receive Chantix or Chantix+Zyban; 23 subjects only received nicotine patches before dropping out.
708304|NCT01802632|P1|Participant Flow|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
707933|NCT01806779|P2|Participant Flow|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707934|NCT01806779|P1|Participant Flow|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707935|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707936|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707937|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707938|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707939|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707940|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
708004|NCT01806389|P1|Participant Flow|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
707941|NCT01806779|O2|Outcome|Chantix + Zyban|"For the first 3 days after being switched from NRT (occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707942|NCT01806779|O1|Outcome|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707943|NCT01806779|E3|Reported Event|Nicotine Patch|All participants will receive Nicotine Replacement Therapy (NRT) in the form of 21 mg/24 h dose nicotine patches for 1 week prior to randomization to treatment with Chantix alone or Chantix + Zyban.
707944|NCT01806779|E2|Reported Event|Chantix + Zyban|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week plus Zyban at a dose of 150mg once per day. Subsequently, the dose of Chantix will be 1 mg twice per day and the dose of Zyban will be 150 mg twice per day for the remainder of the 12-week active treatment duration.~Chantix~Zyban~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
708305|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
707945|NCT01806779|E1|Reported Event|Chantix|"For the first 3 days after being switched from Nicotine Replacement Therapy (NRT, occurring at one week after initiation of nicotine patch treatment, one week before the target Quit Day), smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.~Chantix~Nicotine patches: All participants will receive 21 mg/24 h dose nicotine patches for 1 week."
707946|NCT01806623|B1|Baseline|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707947|NCT01806623|P1|Participant Flow|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707948|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707949|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707950|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707951|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707952|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707953|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707954|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707955|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707956|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707957|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707958|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707959|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707960|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707961|NCT01806623|O1|Outcome|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707962|NCT01806623|E1|Reported Event|Fluconazole|Three fluconazole 50 mg capsules were orally administered once on the first day of the treatment
707963|NCT01806584|B3|Baseline|Total|Total of all reporting groups
707964|NCT01806584|B2|Baseline|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
707965|NCT01806584|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
707966|NCT01806584|P2|Participant Flow|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
707967|NCT01806584|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
709442|NCT01795716|E2|Reported Event|Glivec|Subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
707968|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
707969|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
707970|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
707971|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
707972|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
707973|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
707974|NCT01806584|O2|Outcome|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
707975|NCT01806584|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
707976|NCT01806584|E2|Reported Event|SRM003|"Participants received a single application of 3 sponges at the time of the AVG placement: 1 sponge was wrapped around the venous anastomosis; another sponge was placed longitudinally on the vein segment, immediately distal to the venous anastomosis; and the remaining sponge was wrapped around the arterial anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application.~After surgery, subjects were to undergo assessments during the 78-week follow-up period."
707977|NCT01806584|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 78 weeks of follow-up for assessment of efficacy and safety.
707978|NCT01806545|B3|Baseline|Total|Total of all reporting groups
707979|NCT01806545|B2|Baseline|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707980|NCT01806545|B1|Baseline|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707981|NCT01806545|P2|Participant Flow|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707982|NCT01806545|P1|Participant Flow|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707983|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707984|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707985|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
708165|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
707986|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707987|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707988|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707989|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707990|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707991|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
708232|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
707992|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707993|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707994|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707995|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707996|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707997|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707998|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
707999|NCT01806545|O2|Outcome|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
708000|NCT01806545|O1|Outcome|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
708001|NCT01806545|E2|Reported Event|SRM003|Participants received a one-time implant of 2 SRM003 pieces on surgery day after the completion of the arteriovenous fistula (AVF) creation. One sponge was wrapped around the venous anastomosis site and the other was placed longitudinally on the vein segment, immediately distal to the venous anastomosis. Subjects were not permitted to undergo additional applications with SRM003 sponges after the initial application. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
708002|NCT01806545|E1|Reported Event|Participating Site's Standard Practice|Participants received the site's standard practice treatment during the surgical procedure. Post-surgery, each participant was to undergo 26 weeks of follow-up for assessment of efficacy and safety.
708003|NCT01806389|B1|Baseline|Buprenorphine Maintained Lactating Women|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria
708166|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
708005|NCT01806389|O1|Outcome|INFANT PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing INFANT PLASMA for analysis on day 14
708006|NCT01806389|O5|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 30
708007|NCT01806389|O4|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 14
708008|NCT01806389|O3|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 4
708009|NCT01806389|O2|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing BREAST MILK for analysis on day 3
708010|NCT01806389|O1|Outcome|BREAST MILK Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing breast milk for analysis on day 2
708011|NCT01806389|O5|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 30|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 30
708012|NCT01806389|O4|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 14|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 14
708013|NCT01806389|O3|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 4|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 4
708014|NCT01806389|O2|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 3|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 3
708015|NCT01806389|O1|Outcome|PLASMA Buprenorphine Maintained Lactating Women Day 2|Buprenorphine maintained women at delivery of their infant opting to breastfeed their infants and meeting study criteria and providing plasma for analysis on day 2
708016|NCT01806389|E1|Reported Event|Buprenorphine|Buprenorphine maintained women at delivery of their infant
708017|NCT01806298|B1|Baseline|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708018|NCT01806298|P1|Participant Flow|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708019|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708020|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708021|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708022|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708023|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708024|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708025|NCT01806298|O1|Outcome|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708026|NCT01806298|E1|Reported Event|Saizen®|Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
708027|NCT01806051|B1|Baseline|All Participants|
708028|NCT01806051|P1|Participant Flow|All Participants|Participants signed the consent forms and withdrew because they found the study procedures to be too cumbersome.
708029|NCT01806051|O2|Outcome|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
708030|NCT01806051|O1|Outcome|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
708031|NCT01806051|E2|Reported Event|Control Group (Arm 2)|"Subjects allocated into this group will be healthy, non-PKU individuals that may be a relative (ex: sibling) of a PKU participant, but they don't have to be a blood relation.~These subjects will undergo a 24-Hour Blood Assessment (at Study Visit #2)."
708057|NCT01805882|O4|Outcome|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
708058|NCT01805882|O3|Outcome|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708032|NCT01806051|E1|Reported Event|PKU Participants (Arm 1)|"Subjects will be administered Kuvan once daily.~They will undergo several blood draws, including a 24-Hour Blood Assessment (at Study Visit #2 before the commencement of Kuvan), plasma Phe/Tyr draws (at Study Visits #3, 4, and 5), and another 24-Hour Blood Assessment (at Study Visit #6).~Kuvan: Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks."
708033|NCT01805882|B10|Baseline|Total|Total of all reporting groups
708034|NCT01805882|B9|Baseline|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708035|NCT01805882|B8|Baseline|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708036|NCT01805882|B7|Baseline|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
708037|NCT01805882|B6|Baseline|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
708038|NCT01805882|B5|Baseline|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
708039|NCT01805882|B4|Baseline|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
708040|NCT01805882|B3|Baseline|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708041|NCT01805882|B2|Baseline|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708042|NCT01805882|B1|Baseline|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
708043|NCT01805882|P9|Participant Flow|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708044|NCT01805882|P8|Participant Flow|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708045|NCT01805882|P7|Participant Flow|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
708046|NCT01805882|P6|Participant Flow|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
708047|NCT01805882|P5|Participant Flow|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
708048|NCT01805882|P4|Participant Flow|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
708049|NCT01805882|P3|Participant Flow|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708050|NCT01805882|P2|Participant Flow|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708051|NCT01805882|P1|Participant Flow|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
708052|NCT01805882|O9|Outcome|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708053|NCT01805882|O8|Outcome|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708054|NCT01805882|O7|Outcome|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
708055|NCT01805882|O6|Outcome|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
708056|NCT01805882|O5|Outcome|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
708126|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708059|NCT01805882|O2|Outcome|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708060|NCT01805882|O1|Outcome|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
708061|NCT01805882|E9|Reported Event|H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708062|NCT01805882|E8|Reported Event|G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451|Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
708063|NCT01805882|E7|Reported Event|F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
708064|NCT01805882|E6|Reported Event|E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
708065|NCT01805882|E5|Reported Event|D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
708066|NCT01805882|E4|Reported Event|D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
708067|NCT01805882|E3|Reported Event|C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708068|NCT01805882|E2|Reported Event|B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669|Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
708069|NCT01805882|E1|Reported Event|A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir|Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
708070|NCT01805687|B1|Baseline|Zileuton Extended Release|Zileuton extended release
708071|NCT01805687|P1|Participant Flow|Zileuton Extended Release|Zileuton extended release 1200 mg (2 x 600 mg tablets)
708072|NCT01805687|O1|Outcome|Zileuton Extended Release|Zileuton extended release
708073|NCT01805687|E1|Reported Event|Zileuton Extended Release|Zileuton extended release
708074|NCT01805323|B1|Baseline|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
708075|NCT01805323|P1|Participant Flow|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
708076|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
708077|NCT01805323|O1|Outcome|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
708078|NCT01805323|E1|Reported Event|All Participants|Patients with macular edema previously treated with dexamethasone intravitreal implant (OZURDEX®) according to general clinical practice.
708079|NCT01805180|B3|Baseline|Total|Total of all reporting groups
708080|NCT01805180|B2|Baseline|Arm 2|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708081|NCT01805180|B1|Baseline|Arm 1|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708082|NCT01805180|P3|Participant Flow|Arm 2 - COBE Spectra Followed by Spectra Optia PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the COBE Spectra first, followed by the Spectra Optia.
708083|NCT01805180|P2|Participant Flow|Arm 1 - Spectra Optia Followed by COBE Spectra PMN|Healthy donors who were consented to participate in the pivotal trial and were randomized to receive the PMN collection procedure on the Spectra Optia first, followed by the COBE Spectra.
708084|NCT01805180|P1|Participant Flow|Lead-in Donor|Subjects screened and enrolled for the purpose of training on the investigational procedure only. Included in safety analysis only.
708085|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
708086|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. Device deficiency was not reported by randomization treatment arms.
708087|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708088|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708089|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708090|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708164|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
708091|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708092|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708093|NCT01805180|O1|Outcome|Spectra Optia vs COBE Spectra|All 32 subjects received both the Spectra Optia and the COBE Spectra. RBC contamination results via hematocrit in collected product not reported by randomization treatment arms.
708094|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708095|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708096|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708097|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708098|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708099|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708100|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708101|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708256|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708102|NCT01805180|O2|Outcome|Arm 2 - COBE Spectra Followed by Spectra Optia|In Arm 2 the first PMN cell collection was performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System for each subject.
708103|NCT01805180|O1|Outcome|Arm 1 - Spectra Optia Followed by COBE Spectra|In Arm 1 the first PMN cell collection was performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System for each subject.
708104|NCT01805180|E2|Reported Event|COBE Spectra|A total of n=42 subjects were randomized to receive a procedure. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Lead-in subjects are never exposed to COBE Spectra per protocol and not included. COBE Spectra events are AEs during the study period when the subject received the COBE Spectra.
708105|NCT01805180|E1|Reported Event|Spectra Optia|A total of n=48 subjects were either randomized to receive a procedure (n=42) or were assigned the Spectra Optia as a lead-in subject (lead-in n=6). Lead-in donors were not randomized and received the Spectra Optia only for training purposes and are included for Spectra Optia safety only. Randomized subjects are included in safety regardless if they withdrew or did not complete a procedure. Spectra Optia events are AEs during the study period when the subject received the Spectra Optia.
708106|NCT01805089|B3|Baseline|Total|Total of all reporting groups
708107|NCT01805089|B2|Baseline|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
708108|NCT01805089|B1|Baseline|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
708109|NCT01805089|P2|Participant Flow|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
708110|NCT01805089|P1|Participant Flow|Melatonin 3mg|"Taken orally, once per day, at/around 9:00pm~Melatonin"
708111|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
708112|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
708113|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
708114|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
708115|NCT01805089|O2|Outcome|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
708116|NCT01805089|O1|Outcome|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
708117|NCT01805089|E2|Reported Event|Placebo|"Taken orally, once per day, at/around 9:00pm~Placebo"
708118|NCT01805089|E1|Reported Event|Melatonin|"Taken orally, once per day, at/around 9:00pm~Melatonin"
708119|NCT01804946|B3|Baseline|Total|Total of all reporting groups
708120|NCT01804946|B2|Baseline|Oseltamivir Group (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
708121|NCT01804946|B1|Baseline|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
708122|NCT01804946|P2|Participant Flow|Oseltamivir Group (OG)|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708123|NCT01804946|P1|Participant Flow|Ergoferon Group (EG)|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708124|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708125|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708127|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708128|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708129|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708130|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708131|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708132|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708133|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708134|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708135|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708136|NCT01804946|O2|Outcome|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708137|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
709125|NCT01798264|E3|Reported Event|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
708139|NCT01804946|O1|Outcome|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708140|NCT01804946|O2|Outcome|Oseltamivir Goup (OG)|Oseltamivir(Tamiflu): Safety and Efficiency in treatment of Influenza
708141|NCT01804946|O1|Outcome|Ergoferon Group (EG)|"1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.~Ergoferon: Safety and Efficiency of Ergoferon in treatment of Influenza"
708142|NCT01804946|E2|Reported Event|Oseltamivir Group|Adults aged 18 to 60 years were on Oseltamivir for 5 days (75 mg b.i.d.).
708143|NCT01804946|E1|Reported Event|Ergoferon Group|Adults aged 18 to 60 years were on the treatment regimen with Ergoferon for 5 days. 1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet t.i.d.
708144|NCT01804881|B3|Baseline|Total|Total of all reporting groups
708145|NCT01804881|B2|Baseline|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
708146|NCT01804881|B1|Baseline|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
708147|NCT01804881|P2|Participant Flow|Wait List Control|wait list, offered program based on craving change(tm) material at end of study
708148|NCT01804881|P1|Participant Flow|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
708149|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
708150|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
708151|NCT01804881|O2|Outcome|Wait List Control|wait list, offered group program at end of study
708152|NCT01804881|O1|Outcome|Lifestyle Counseling|"Group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
708153|NCT01804881|O2|Outcome|Wait List Control|wait list, offered craving change program at end of study
708154|NCT01804881|O1|Outcome|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
708155|NCT01804881|E2|Reported Event|Wait List Control|wait list, offered craving change program at end of study
708156|NCT01804881|E1|Reported Event|Lifestyle Counseling|"Craving change group intervention for dietary counseling, 6 group sessions~Lifestyle counseling: Six week program to address problematic eating"
708157|NCT01804842|B4|Baseline|Total|Total of all reporting groups
708158|NCT01804842|B3|Baseline|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
708159|NCT01804842|B2|Baseline|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
708160|NCT01804842|B1|Baseline|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
708161|NCT01804842|P3|Participant Flow|Sequence 3: CAB|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
708162|NCT01804842|P2|Participant Flow|Sequence 2: BCA|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
708163|NCT01804842|P1|Participant Flow|Sequence 1: ABC|Treatment A = 1000 mg Met DR qAM Treatment B = 1000 mg Met DR qPM Treatment C = 500 mg Met DR BID
710223|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
708167|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
708168|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
708169|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
708170|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
708171|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
708172|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
708173|NCT01804842|O3|Outcome|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
708174|NCT01804842|O2|Outcome|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
708175|NCT01804842|O1|Outcome|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
708176|NCT01804842|E3|Reported Event|500 mg Met DR BID|"Two doses of 500 mg metformin delayed-release~Met DR: metformin delayed-release tablets"
708177|NCT01804842|E2|Reported Event|1000 mg Met DR qPM|"One dose of 1000 mg metformin delayed-release in the evening~Met DR: metformin delayed-release tablets"
708178|NCT01804842|E1|Reported Event|1000 mg Met DR qAM|"One dose of 1000 mg metformin delayed-release in the morning~Met DR: metformin delayed-release tablets"
708179|NCT01804673|B1|Baseline|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708300|NCT01802632|P5|Participant Flow|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
708180|NCT01804673|P1|Participant Flow|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708181|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708182|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708183|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708184|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708185|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708186|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708187|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708188|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708189|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708190|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708191|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708192|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708193|NCT01804673|O1|Outcome|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
708194|NCT01804673|E1|Reported Event|Fentanyl|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) releasing fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment was up to 72 hours.
710224|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
708195|NCT01804257|B1|Baseline|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor~Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
708196|NCT01804257|P1|Participant Flow|Digital Health Feedback System (DHFS)|"Ingestion Sensor, Wearable Sensor~Digital Health Feedback System: The digital health offering passively collects and records medication-taking behavior and other habits of daily living"
708197|NCT01804257|O1|Outcome|Digital Health Feedback System (DHFS)|Ingestion Sensor,...
708198|NCT01804257|E1|Reported Event|Digital Health Feedback System (DHFS)|DHFS
708199|NCT01804140|B1|Baseline|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
708200|NCT01804140|P1|Participant Flow|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
708201|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
708202|NCT01804140|O1|Outcome|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
708203|NCT01804140|E1|Reported Event|Participants With Confirmed Solid Tumors or Multiple Myeloma|Participants with solid tumors (other than metastatic melanoma or papillary thyroid cancer) or multiple myeloma who met the inclusion criteria and did not meet exclusion criteria of the study were enrolled and were evaluated for the presence of BRAF V600 mutations by collecting tumor samples or performing fresh biopsies according to local standards.
708204|NCT01804062|B1|Baseline|no Treatment|no treatment, prospective observational
708205|NCT01804062|P1|Participant Flow|no Treatment|no treatment, prospective observational
708206|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
708207|NCT01804062|O1|Outcome|no Treatment|no treatment, prospective observational
708208|NCT01804062|E1|Reported Event|no Treatment|no treatment, prospective observational
708209|NCT01804036|B3|Baseline|Total|Total of all reporting groups
708210|NCT01804036|B2|Baseline|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708211|NCT01804036|B1|Baseline|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
708212|NCT01804036|P2|Participant Flow|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708213|NCT01804036|P1|Participant Flow|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708214|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708215|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
708216|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708217|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
708218|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708219|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
708220|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708221|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708222|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708223|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708224|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708225|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708226|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708227|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708228|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708229|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708230|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708231|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708301|NCT01802632|P4|Participant Flow|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
708233|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708234|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708235|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
708236|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708237|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem: Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed."
708238|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708239|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708240|NCT01804036|O2|Outcome|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708241|NCT01804036|O1|Outcome|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708242|NCT01804036|E2|Reported Event|Mind-Body Bridging|"An awareness training program using mindfulness-based techniques.~Mind-Body Bridging: An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session"
708243|NCT01804036|E1|Reported Event|Zolpidem (Ambien) Treatment|"A three week treatment of Zolpidem~Zolpidem:~Week 1: half dose of Zolpidem on the first night (5 mg: males/2.5 mg: females), remaining six nights, 5-10 mg (males), 2.5-5 mg (females) nightly Week 2: half or full dose, as needed. Week 3: requested to taper off sleep medication with half-dose, as needed."
708244|NCT01803737|B3|Baseline|Total|Total of all reporting groups
708245|NCT01803737|B2|Baseline|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708246|NCT01803737|B1|Baseline|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708247|NCT01803737|P2|Participant Flow|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708248|NCT01803737|P1|Participant Flow|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
710225|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
708249|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708250|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708251|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708252|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708253|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708254|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708255|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708257|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708258|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708259|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708260|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708261|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708262|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708263|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708264|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708265|NCT01803737|O2|Outcome|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708266|NCT01803737|O1|Outcome|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708267|NCT01803737|E2|Reported Event|Campaign Intervention (CI)|Includes changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
708268|NCT01803737|E1|Reported Event|Standard Behavioral Weight Loss Intervention (SBWL)|Includes changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
708269|NCT01803607|B3|Baseline|Total|Total of all reporting groups
708353|NCT01802320|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
708354|NCT01802151|B5|Baseline|Total|Total of all reporting groups
708270|NCT01803607|B2|Baseline|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708271|NCT01803607|B1|Baseline|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708272|NCT01803607|P2|Participant Flow|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708273|NCT01803607|P1|Participant Flow|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708274|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708275|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708276|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708302|NCT01802632|P3|Participant Flow|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
708277|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708278|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708279|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708280|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708281|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708282|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708283|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708284|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708285|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708286|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708287|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
710226|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
708288|NCT01803607|O2|Outcome|Placebo|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708289|NCT01803607|O1|Outcome|Odanacatib 50 mg|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708290|NCT01803607|E2|Reported Event|Placebo OW|Participants received dose-matched placebo to odanacatib OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium. One participant who was randomized to odanacatib 50 mg OW received placebo during the entire treatment period and was therefore included in the Placebo OW group for safety analyses.
708291|NCT01803607|E1|Reported Event|ODN 50 mg OW|Participants received odanacatib 50 mg OW for 24 months. In addition, participants received Vitamin D 5600 IU as well as open-label daily calcium supplement of 500 mg (sourced locally as calcium carbonate or calcium citrate) to ensure a total daily intake (from both dietary and supplemental sources) of approximately 1200 mg of elemental calcium.
708292|NCT01802632|B7|Baseline|Total|Total of all reporting groups
708293|NCT01802632|B6|Baseline|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
708294|NCT01802632|B5|Baseline|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
708295|NCT01802632|B4|Baseline|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
708296|NCT01802632|B3|Baseline|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
708297|NCT01802632|B2|Baseline|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
708298|NCT01802632|B1|Baseline|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
708299|NCT01802632|P6|Participant Flow|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
708306|NCT01802632|O1|Outcome|80mg AZD9291 Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
708307|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
708308|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) population. Dose groups were expanded to include more patients.
708309|NCT01802632|O1|Outcome|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
708310|NCT01802632|O1|Outcome|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
708311|NCT01802632|E6|Reported Event|Japan Cytology|Japan-only cohort of patients (EGFR T790M mutation status determined from cytology samples) receiving AZD9291 80 mg tablet.
708312|NCT01802632|E5|Reported Event|80mg Tablet|US-only cohort of pre-treated EGFR patients receiving the tablet formulation of AZD9291 (80 mg).
708313|NCT01802632|E4|Reported Event|First Line|Cohort of patients receiving first-line treatment for EGFRm advanced NSCLC, in 80mg and 160mg AZD9291 capsule.
708314|NCT01802632|E3|Reported Event|Dose Expansion|Pre-treated EGFR T790M mutation positive (by central testing) patient cohort. Dose groups were expanded to include more patients.
708315|NCT01802632|E2|Reported Event|Dose Escalation|Pre-treated patient cohort in doses 20, 40, 80, 160 and 240mg AZD9291 capsule.
708316|NCT01802632|E1|Reported Event|AZD9291 80mg Extension|Phase II dose extension cohort in pre-treated EGFR T790M mutation positive patients in AZD9291 80mg tablet.
708317|NCT01802554|B3|Baseline|Total|Total of all reporting groups
708318|NCT01802554|B2|Baseline|Information Support (IS)|Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.
708319|NCT01802554|B1|Baseline|Pleasant Events Program (PEP)|The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.
708320|NCT01802554|P2|Participant Flow|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP) : Behavioral Activation Therapy"
708331|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
708454|NCT01801475|E1|Reported Event|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
708321|NCT01802554|P1|Participant Flow|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers' needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS) : Supportive Psychotherapy and informational brochures"
708322|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
708323|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
708324|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
708325|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
708326|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
708327|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
708328|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
708329|NCT01802554|O1|Outcome|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
708330|NCT01802554|O2|Outcome|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
710227|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
708332|NCT01802554|E2|Reported Event|Information-Support (IS)|"Participants in the IS control condition were provided with a resource manual consisting of topics commonly covered in support groups or information packets provided by community agencies. Topics included problem-solving and communication skills, cognitive reframing and behavioral management, self-care help, caregiver fact sheets on a range of social and mental health issues, placement information, financial and legal issues, and lists of local organizations and community resources available. Less structured than the PEP condition, each IS session allowed caregivers to select which issue(s) from the resource manual they would like to discuss, if any, and the therapist covered the material based on the caregivers’ needs. When requested by the caregiver, supportive psychotherapy was also provided.~Information Support (IS): Supportive Psychotherapy and informational brochures"
708333|NCT01802554|E1|Reported Event|Pleasant Events Program (PEP)|"The Pleasant Events Program (PEP) is a Behavioral Activation (BA) treatment for depression. Participants receive 4 weekly sessions of face-to-face therapy (60 minutes each) to increase caregiver participation in pleasurable activities. Two additional phone sessions focus on continued behavioral activation for caregivers as well as problem-solving barriers to activation.~Pleasant Events Program (PEP): Behavioral Activation Therapy"
708334|NCT01802515|B4|Baseline|Total|Total of all reporting groups
708335|NCT01802515|B3|Baseline|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
708336|NCT01802515|B2|Baseline|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
708337|NCT01802515|B1|Baseline|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
708338|NCT01802515|P3|Participant Flow|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
708339|NCT01802515|P2|Participant Flow|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
708368|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708340|NCT01802515|P1|Participant Flow|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
708341|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
708342|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
708343|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
708344|NCT01802515|O3|Outcome|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
708345|NCT01802515|O2|Outcome|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
708346|NCT01802515|O1|Outcome|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
708347|NCT01802515|E3|Reported Event|Placebo (Sugar Pill)|"1 placebo capsule by mouth everyday for 8 weeks of treatment invention followed by one week of placebo capsule during study medication taper.~Placebo: The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose."
708348|NCT01802515|E2|Reported Event|Atomoxetine, High Dose|"One capsule containing 80mg of atomoxetine by mouth everyday for 8 weeks, followed by 1 week of daily 40mg atomoxetine capsules~Atomoxetine, high dose: The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose."
708349|NCT01802515|E1|Reported Event|Atomoxetine, Low Dose|"1 capsule containing 40mg of atomoxetine by mouth everyday for 8 weeks followed by 1 week of daily placebo capsules.~Atomoxetine, low dose: The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose."
708350|NCT01802320|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
708351|NCT01802320|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
708352|NCT01802320|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
708455|NCT01801436|B1|Baseline|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708355|NCT01802151|B4|Baseline|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708356|NCT01802151|B3|Baseline|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708357|NCT01802151|B2|Baseline|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708358|NCT01802151|B1|Baseline|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708359|NCT01802151|P4|Participant Flow|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708360|NCT01802151|P3|Participant Flow|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708361|NCT01802151|P2|Participant Flow|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708362|NCT01802151|P1|Participant Flow|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708363|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708364|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708365|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708366|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708367|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708369|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708370|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708371|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708372|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708373|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708374|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708375|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708376|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708377|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708378|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708379|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708380|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708381|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708382|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708383|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708384|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708385|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708386|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708387|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708388|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708389|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708390|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708391|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708392|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708393|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708394|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708395|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708396|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708397|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708398|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708399|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708400|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708401|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708402|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708403|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708404|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708405|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708406|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708407|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708408|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708409|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708410|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708411|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708412|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708413|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708414|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708415|NCT01802151|O4|Outcome|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708416|NCT01802151|O3|Outcome|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708417|NCT01802151|O2|Outcome|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708418|NCT01802151|O1|Outcome|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708419|NCT01802151|E4|Reported Event|B. Subtilis R0179 (10 Billion CFU)|"B. subtilis R0179 (approximately 10 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708420|NCT01802151|E3|Reported Event|B. Subtilis R0179 (1 Billion CFU)|"B. subtilis R0179 (approximately 1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708421|NCT01802151|E2|Reported Event|B. Subtilis R0179 (0.1 Billion CFU)|"B. subtilis R0179 (approximately 0.1 billion CFU/capsule) once daily for 4 weeks.~B. subtilis R0179: B. subtilis R0179 for a period of 4 weeks. One capsule per day."
708422|NCT01802151|E1|Reported Event|Placebo|"Placebo (starch, magnesium stearate, citric acid) capsules once daily for 4 weeks.~Placebo: Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day."
708423|NCT01801982|B1|Baseline|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708424|NCT01801982|P1|Participant Flow|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708425|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708426|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708427|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708428|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708429|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708430|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708431|NCT01801982|O1|Outcome|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708669|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708432|NCT01801982|E1|Reported Event|Sildenafil|Participants who received intravenous (IV) sildenafil treatment in study A1481276 (NCT01069861) were followed-up for safety, up to Month 24.
708433|NCT01801735|B1|Baseline|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
708434|NCT01801735|P1|Participant Flow|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
708435|NCT01801735|O1|Outcome|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
708436|NCT01801735|E1|Reported Event|Meloxicam 10 mg|Participants were administered Meloxicam 10 mg once daily for up to 52 weeks.
708437|NCT01801475|B4|Baseline|Total|Total of all reporting groups
708438|NCT01801475|B3|Baseline|Neonates|"Babies of the pregnant women enrolled in the study; no ondansetron is given to babies in this Aim 1 of the study. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours."
708439|NCT01801475|B2|Baseline|Non-pregnant Women|"Non-pregnant women scheduled for surgery at Stanford who will be given Ondansetron prior to their surgery as standard-of-care.~Ondansetron: non-pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
708440|NCT01801475|B1|Baseline|Pregnant Women|"Full term pregnant women scheduled for Cesarean section and will be given Ondansetron as standard-of-care prior to surgery.~Ondansetron: Pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours."
708441|NCT01801475|P5|Participant Flow|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
708442|NCT01801475|P4|Participant Flow|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
708443|NCT01801475|P3|Participant Flow|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
708444|NCT01801475|P2|Participant Flow|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
708445|NCT01801475|P1|Participant Flow|Ondansetron 4 mg IV - Pregnant|Ondansetron 4 mg was given intravenously prior to delivery of the infant.
708446|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
708447|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
708448|NCT01801475|O2|Outcome|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
708449|NCT01801475|O1|Outcome|Women - Pregnant/Non-pregnant|Ondansetron 4 mg or 8mg was given intravenously prior to delivery of her baby in pregnant women and was given to age similar women in the non-pregnant group.
708450|NCT01801475|E5|Reported Event|Neonates|The neonates became part of the subject population after birth. They were subsequently sampled for pharmacokinetic samples.
708451|NCT01801475|E4|Reported Event|Non-pregnant Women - 4 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 4 mg ondansetron
708452|NCT01801475|E3|Reported Event|Non-pregnant Women - 8 mg Ondansetron|As a comparison for pharmacokinetics, a non-pregnant group was enrolled and received ondansetron. 8 mg ondansetron
708453|NCT01801475|E2|Reported Event|Ondansetron 8 mg IV - Pregnant|Ondansetron 8 mg was given intravenously prior to delivery of the infant.
708456|NCT01801436|P1|Participant Flow|Bortezomib|Participants received 1.3 milligram per meter square (mg per m^2) of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708457|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708458|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708459|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708460|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708461|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708462|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708463|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708464|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708465|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708466|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708467|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708468|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708469|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708470|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708471|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708472|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708473|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708474|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708475|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708476|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708477|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708478|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708479|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708480|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708481|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708482|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708483|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708484|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708485|NCT01801436|O1|Outcome|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708486|NCT01801436|E1|Reported Event|Bortezomib|Participants received 1.3 mg per m^2 of bortezomib on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
708487|NCT01801358|B7|Baseline|Total|Total of all reporting groups
708488|NCT01801358|B6|Baseline|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708489|NCT01801358|B5|Baseline|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708490|NCT01801358|B4|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708491|NCT01801358|B3|Baseline|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708492|NCT01801358|B2|Baseline|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708493|NCT01801358|B1|Baseline|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708494|NCT01801358|P6|Participant Flow|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708495|NCT01801358|P5|Participant Flow|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708496|NCT01801358|P4|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708497|NCT01801358|P3|Participant Flow|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708498|NCT01801358|P2|Participant Flow|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708499|NCT01801358|P1|Participant Flow|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708500|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708501|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708502|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708503|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708504|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708505|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708506|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708507|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708508|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708509|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708670|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708510|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708511|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708512|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708513|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708514|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708515|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708516|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708517|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708518|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708519|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708520|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708521|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708522|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708523|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708524|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708525|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708526|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708527|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708528|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708529|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708530|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708531|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708532|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708533|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708534|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708535|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708536|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708537|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708538|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708539|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708540|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708541|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708542|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708543|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708544|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708671|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708545|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708546|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708547|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708548|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708549|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708550|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708551|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708552|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708553|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708554|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708555|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708556|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708557|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708558|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708559|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708560|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708561|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708562|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708563|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708564|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708565|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708566|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708567|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708568|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708569|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708570|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708571|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (PAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708572|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
708573|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
708574|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
708575|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
708576|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708577|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708578|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708579|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708580|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708581|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708582|NCT01801358|O1|Outcome|Phase Ib (Dose Escalation)|"For Phase Ib, a minimum of three patients will be entered into each cohort and evaluated for safety (DLTs and any other medically significant event) at the end of Cycle 1.~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708583|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708584|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708585|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708586|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708587|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708588|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (FAS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708589|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
708590|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708591|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708592|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708593|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708594|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708595|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708596|NCT01801358|O7|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
708597|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708598|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708599|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708600|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708601|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708602|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708603|NCT01801358|O1|Outcome|Phase II (Dose Expansion)|Following the determination of the maximum tolerated dose (MTD) or the recommended phase two dose (RP2D), patients would have been randomized into two arms in a 1:1 ratio, to receive AEB071 and MEK162 or MEK162 alone. However, due to an enrollment halt, the Phase II part of the study did not occur.
708604|NCT01801358|O6|Outcome|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708605|NCT01801358|O5|Outcome|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708606|NCT01801358|O4|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708607|NCT01801358|O3|Outcome|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708608|NCT01801358|O2|Outcome|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708609|NCT01801358|O1|Outcome|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (DDS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708610|NCT01801358|E6|Reported Event|Phase Ib: AEB071 400 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
709126|NCT01798264|E2|Reported Event|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
708611|NCT01801358|E5|Reported Event|Phase Ib: AEB071 350 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708612|NCT01801358|E4|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708613|NCT01801358|E3|Reported Event|Phase Ib: AEB071 300 mg Bid + MEK162 30 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708614|NCT01801358|E2|Reported Event|Phase Ib: AEB071 200 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708615|NCT01801358|E1|Reported Event|Phase Ib: AEB071 150 mg Bid + MEK162 45 mg Bid (SS)|"Phase Ib (Dose Escalation)~Phase Ib was the combination of sotrastaurin and binimetinib administered orally bid."
708616|NCT01801280|B5|Baseline|Total|Total of all reporting groups
708617|NCT01801280|B4|Baseline|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
708618|NCT01801280|B3|Baseline|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
708619|NCT01801280|B2|Baseline|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
708620|NCT01801280|B1|Baseline|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
708621|NCT01801280|P4|Participant Flow|Sequence D|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
708622|NCT01801280|P3|Participant Flow|Sequence C|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~nd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~th period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d."
708652|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708623|NCT01801280|P2|Participant Flow|Sequence B|"st period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~rd period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d."
708624|NCT01801280|P1|Participant Flow|Sequence A|"st period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d.~nd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d.~rd period: Mycophenolate sodium (EC-MPS) tablet (720, 1080, 1440) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d.~th period: Mycophenolate mofetil (MMF) tablet (500, 750 or 1000mg) b.i.d. every 12 hours for 10-14d. Pantoprazole 40mg tablet (PAN) each for 10-14d."
708625|NCT01801280|O4|Outcome|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
708626|NCT01801280|O3|Outcome|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
708627|NCT01801280|O2|Outcome|MMF+PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
708628|NCT01801280|O1|Outcome|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
708629|NCT01801280|E4|Reported Event|EC-MPS + PAN|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate sodium.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
708630|NCT01801280|E3|Reported Event|EC-MPS|"Mycophenolate sodium (EC-MPS) tablet twice a day every 12 hours for two weeks.~Mycophenolate sodium daily dose: 720mg, 1080mg, 1440mg."
708631|NCT01801280|E2|Reported Event|MMF + PAN|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg.~Pantoprazole daily dose: 40mg once in the morning together with Mycophenolate mofetil.~Pantoprazole tablet (PAN) once a day in the morning for two weeks."
708672|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708632|NCT01801280|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Mycophenolate mofetil (MMF) tablet twice a day every 12 hours for two weeks.~Mycophenolate mofetil daily dose: 1000mg, 1500mg, 2000mg."
708633|NCT01801124|B1|Baseline|EXPAREL|undiluted EXPAREL 266 mg
708634|NCT01801124|P1|Participant Flow|EXPAREL|undiluted EXPAREL 266 mg
708635|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
708636|NCT01801124|O1|Outcome|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
708637|NCT01801124|E1|Reported Event|EXPAREL|Subjects receiving 266 mg EXPAREL to infiltrate into the bilateral TAPs.
708638|NCT01801111|B1|Baseline|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708639|NCT01801111|P1|Participant Flow|Alectinib|Participants received alectinib 600 milligrams (mg), capsule, orally, twice daily (BID), continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708640|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708641|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708642|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708643|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708644|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708645|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708646|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708647|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708648|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708649|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708650|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708651|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708706|NCT01800916|B1|Baseline|Overall Study Population|
710228|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
708653|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708654|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708655|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708656|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708657|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708658|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708659|NCT01801111|O1|Outcome|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708660|NCT01801111|E1|Reported Event|Alectinib|Participants received alectinib 600 mg, capsule, orally, BID, continuously starting on Cycle 1 (28-day cycle), Day 1 until disease progression, death, or withdrawal for any other reasons.
708661|NCT01800968|B3|Baseline|Total|Total of all reporting groups
708662|NCT01800968|B2|Baseline|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708663|NCT01800968|B1|Baseline|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708664|NCT01800968|P2|Participant Flow|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708665|NCT01800968|P1|Participant Flow|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708666|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708667|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708668|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708675|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708676|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708677|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708678|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708679|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708680|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708681|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708682|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708683|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708684|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708685|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708686|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708687|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708688|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708689|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708690|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708691|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708692|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708693|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708694|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708695|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708696|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708697|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708698|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708699|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708700|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708701|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708702|NCT01800968|O2|Outcome|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous daily.~Placebo: Placebo"
708703|NCT01800968|O1|Outcome|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous daily.~Liraglutide: Active Drug"
708704|NCT01800968|E2|Reported Event|Placebo|"Placebo dose increasing from 0.6mg, 1.2mg to 1.8 mg subcutaneous (SQ) daily.~Placebo: Placebo"
708705|NCT01800968|E1|Reported Event|Liraglutide|"Increasing dose from 0.6mg, 1.2mg to 1.8mg subcutaneous (SQ) daily.~Liraglutide: Active Drug"
708707|NCT01800916|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested SenSura then Coloplast test product C and finally Coloplast test product B
708708|NCT01800916|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product C
708709|NCT01800916|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested SenSura then Coloplast test product A and finally Coloplast test product B
708710|NCT01800916|P6|Participant Flow|Test C/SenSura/Test A|The subjects first tested Coloplast test product C then SenSura and finally Coloplast test product A
708711|NCT01800916|P5|Participant Flow|Test C/Test B/SenSura|The subjects first tested Coloplast test product C then Coloplast test product A and finally the comparator SenSura
708712|NCT01800916|P4|Participant Flow|Test B/SenSura/Test C|The subjects first tested Coloplast test product A then SenSura and finally Coloplast test product B
708713|NCT01800916|P3|Participant Flow|Test B/SenSura/Test A|The subjects first tested Coloplast test product B then SenSura and finally Coloplast test product A
708714|NCT01800916|P2|Participant Flow|Test A/Test C/SenSura|The subjects first tested Coloplast test product A then Coloplast test product C and finally the comparator SenSura
708715|NCT01800916|P1|Participant Flow|Test A/Test B/SenSura|The subjects first tested Coloplast test product A then Coloplast test product B and finally the comparator SenSura
708716|NCT01800916|O4|Outcome|SenSura|
708717|NCT01800916|O3|Outcome|Test C|
708718|NCT01800916|O2|Outcome|Test B|
708719|NCT01800916|O1|Outcome|Test A|
708720|NCT01800916|E4|Reported Event|SenSura|
708721|NCT01800916|E3|Reported Event|Test C|
708722|NCT01800916|E2|Reported Event|Test B|
708723|NCT01800916|E1|Reported Event|Test A|
708724|NCT01800903|B1|Baseline|All Participants|The intention to treat population consists of 36 healthy male subjects
708725|NCT01800903|P6|Participant Flow|ZN-C Catheter Then ZN-D Catheter Then SpeediCath Catheter|First ZN-C catheter then ZN-D catheter then SpeediCath catheter
708726|NCT01800903|P5|Participant Flow|ZN-C Catheter Then SpeediCath Catheter Then ZN-D Catheter|First ZN-C catheter then SpeediCath catheter then ZN-D catheter
708727|NCT01800903|P4|Participant Flow|ZN-D Catheter Then ZN-C Catheter Then SpeediCath Catheter|First ZN-D catheter then ZN-C catheter then SpeediCath catheter
708728|NCT01800903|P3|Participant Flow|ZN-D Catheter Then SpeediCath Catheter Then ZN-C Catheter|First ZN-D catheter then SpeediCath catheter then ZN-C catheter
708729|NCT01800903|P2|Participant Flow|SpeediCath Catheter Then ZN-C Catheter Then ZN-D Catheter|First SpeediCath catheter then ZN-C catheter then ZN-D catheter
708730|NCT01800903|P1|Participant Flow|SpeediCath Catheter Then ZN-D Catheter Then ZN-C Catheter|First SpeediCath catheter then ZN-D catheter then ZN-C catheter
708731|NCT01800903|O3|Outcome|SpeediCath|Subjects who tested the Speedicath catheter
708732|NCT01800903|O2|Outcome|ZN-C Catheter|Subjects who tested the ZN-C catheter
708733|NCT01800903|O1|Outcome|ZN-D Catheter|Subjects who tested the ZN-D catheter
708734|NCT01800903|E1|Reported Event|All Participants|"Data from subjects in the safety population. Definition of safety population: subjects that have given informed consent and have been exposed to at least one product.~However for 4 of these subjects no endpoint data was obtained and they were not included in the ITT population; they therefore do not appear in the participant flow module."
708735|NCT01800890|B1|Baseline|Overall Study Population|baseline data is given for subjects in the ITT population
708736|NCT01800890|P9|Participant Flow|SenSura/Test C/Test B|The subjects first tested the comparator product SenSura then Coloplast test product C and finally Cololpast test product B
708737|NCT01800890|P8|Participant Flow|SenSura/Test A/Test C|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product C
708738|NCT01800890|P7|Participant Flow|SenSura/Test A/Test B|The subjects first tested the comparator product SenSura then Coloplast test product A and finally Cololpast test product B
708739|NCT01800890|P6|Participant Flow|Test C/ SenSura/ Test A|The subjects first tested Coloplast test product C then the comparator SenSura and finally Cololpast test product A
708740|NCT01800890|P5|Participant Flow|Test C/ Test B/ SenSura|The subjects first tested Coloplast test product C then Cololpast test product B and finally the comparator SenSura
708741|NCT01800890|P4|Participant Flow|Test B/ SenSura/ Test C|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product C
708742|NCT01800890|P3|Participant Flow|Test B/ SenSura/ Test A|The subjects first tested Coloplast test product B then the comparator SenSura and finally Cololpast test product A
708743|NCT01800890|P2|Participant Flow|Test A/ Test C/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product C and finally the comparator SenSura
708744|NCT01800890|P1|Participant Flow|Test A/ Test B/ SenSura|The subjects first tested Coloplast test product A then Cololpast test product B and finally the comparator SenSura
708745|NCT01800890|O4|Outcome|SenSura|The comparator
708746|NCT01800890|O3|Outcome|Coloplast Test Product C|new test product
708747|NCT01800890|O2|Outcome|Coloplast Test Product B|new test product
708748|NCT01800890|O1|Outcome|Coloplast Test Product A|new test product
708749|NCT01800890|E4|Reported Event|SenSura|The comparator was the CE-marked product SenSura Click
708750|NCT01800890|E3|Reported Event|Coloplast Test Product C|Coloplast Test product C is a new test product
708751|NCT01800890|E2|Reported Event|Coloplast Test Product B|Coloplast Test product B is a new test product
708752|NCT01800890|E1|Reported Event|Coloplast Test Product A|Coloplast Test product A is a new test product
708753|NCT01800786|B3|Baseline|Total|Total of all reporting groups
708754|NCT01800786|B2|Baseline|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
708755|NCT01800786|B1|Baseline|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
708756|NCT01800786|P2|Participant Flow|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
708757|NCT01800786|P1|Participant Flow|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
708759|NCT01800786|O1|Outcome|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
708760|NCT01800786|E2|Reported Event|OSA -no CPAP|newly diagnosed OSA patient will not wear CPAP for 3 months
708761|NCT01800786|E1|Reported Event|OSA-CPAP Group|"OSA patient will use CPAP for 3 months~CPAP= continuous positive airway pressure therapy~OSA= obstructive sleep apnea"
708762|NCT01800318|B5|Baseline|Total|Total of all reporting groups
708763|NCT01800318|B4|Baseline|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708764|NCT01800318|B3|Baseline|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
708822|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
709127|NCT01798264|E1|Reported Event|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
708765|NCT01800318|B2|Baseline|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs. at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708766|NCT01800318|B1|Baseline|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708767|NCT01800318|P4|Participant Flow|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708768|NCT01800318|P3|Participant Flow|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
708808|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708809|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708899|NCT01799720|E1|Reported Event|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708900|NCT01799590|B4|Baseline|Total|Total of all reporting groups
708769|NCT01800318|P2|Participant Flow|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708770|NCT01800318|P1|Participant Flow|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708771|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708772|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
709341|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
708773|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708774|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708775|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708776|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. ."
708777|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. .(b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. .~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708778|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708779|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708780|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
709338|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
708781|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708782|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708783|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708810|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708811|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
709084|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
708784|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
708785|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708786|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708787|NCT01800318|O4|Outcome|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708788|NCT01800318|O3|Outcome|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
709339|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
708789|NCT01800318|O2|Outcome|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, four small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water:1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708790|NCT01800318|O1|Outcome|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708791|NCT01800318|E4|Reported Event|Sham NESAP With Oral Water|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose."
708792|NCT01800318|E3|Reported Event|NESAP With 24% Oral Sucrose|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. The Empi Select TENS unit will be turned on ten minutes before the heel stick. (b) Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier."
708793|NCT01800318|E2|Reported Event|NESAP With Oral Water|"(a) NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. 10 minutes before the heel stick, the Empi Select TENS unit will be turned on. (b) Infant will receive 1 ml of sterile water given via oral syringe along with a pacifier two minutes before the heel stick.~NESAP: Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at four specific acupuncture points A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick.~Oral water: For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick."
708794|NCT01800318|E1|Reported Event|Sham NESAP With 24% Oral Sucrose|"Sham NESAP: Four Stim Care electrodes with gel backing will be placed on the infant's lower leg at acupuncture points. However, the Empi Select TENS unit will not be turned on. The TENS unit will be hidden from investigators so that they are blinded to the status of the unit.~Infant will receive 1 ml of 24% oral sucrose solution given along with a pacifier two minutes before the heel stick. Investigators will be blinded to the solution given.~24% oral Sucrose: One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.~Sham NESAP: Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP)."
708795|NCT01800162|B4|Baseline|Total|Total of all reporting groups
708796|NCT01800162|B3|Baseline|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
708797|NCT01800162|B2|Baseline|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
708798|NCT01800162|B1|Baseline|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
708799|NCT01800162|P3|Participant Flow|Expectant Management|"Subjects will have their PPUL expectantly managed using serum hCG monitoring.~Expectant Management: Pregnancy will be expectantly managed using serum hcg monitoring."
709502|NCT01794741|O2|Outcome|Fluticasone Nasal Spray|
708800|NCT01800162|P2|Participant Flow|Empiric Treatment With MTX for All|"Subjects will be treated with methotrexate, receiving one dose on day 0 and a subsequent dose on day 4. Additional doses will be administered as needed based on hCG levels.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels."
708801|NCT01800162|P1|Participant Flow|Uterine Evacuation, Then MTX for Some|"Subjects will undergo a uterine evacuation. If hCG levels do not sufficiently decrease after the uterine evacuation, the subject will be treated with methotrexate. If hCG levels do sufficiently decrease after the uterine evacuation, no further treatment is required.~Methotrexate: Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.~Uterine Evacuation: Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation."
708802|NCT01800162|O2|Outcome|Expectant Management|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
708803|NCT01800162|O1|Outcome|Uterine Evacuation|Data was not analyzed as the study was closed early. Data is not anticipated to be analyzed for this study. Patients were not followed for outcome.
708804|NCT01800162|E2|Reported Event|Expectant Management|No AE to Report
708805|NCT01800162|E1|Reported Event|Uterine Evacuation|No AE to Report
708806|NCT01799941|B1|Baseline|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708807|NCT01799941|P1|Participant Flow|Dextromethorphan Hydrobromide 20 mg + Quinidine Sulfate 10 mg|Participants who received fixed-dose combination of 20 milligram (mg) dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
710229|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
708812|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708813|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708814|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708815|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708816|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708817|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708818|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708819|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708820|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708821|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708874|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708823|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708824|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708825|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708826|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708827|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708828|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708829|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708830|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708831|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708832|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708833|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708834|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708835|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708836|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708837|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708838|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708839|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708840|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708841|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708842|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708843|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708844|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708875|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708845|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708846|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708847|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708848|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708849|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708850|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708851|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708852|NCT01799941|O4|Outcome|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708853|NCT01799941|O3|Outcome|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708854|NCT01799941|O2|Outcome|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708855|NCT01799941|O1|Outcome|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708856|NCT01799941|E4|Reported Event|Traumatic Brain Injury|Participants with traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708857|NCT01799941|E3|Reported Event|Stroke|Participants with stroke who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708858|NCT01799941|E2|Reported Event|Dementia|Participants with dementia who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708859|NCT01799941|E1|Reported Event|Overall|Participants with dementia, stroke, and traumatic brain injury who received fixed-dose combination of 20 mg dextromethorphan hydrobromide and 10 mg quinidine sulfate, orally once daily in the morning for the first week of the study, and twice daily (every 12 hours) for the remaining 11 weeks of the study.
708860|NCT01799720|B4|Baseline|Total|Total of all reporting groups
708861|NCT01799720|B3|Baseline|Only Diet|Participants from group 3 only received the diet. Follow-up 30 days.
708862|NCT01799720|B2|Baseline|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the most oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708863|NCT01799720|B1|Baseline|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708864|NCT01799720|P3|Participant Flow|Diet|Participants from group 3 took only diet, Follow-up 30 days
708865|NCT01799720|P2|Participant Flow|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules a day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
708866|NCT01799720|P1|Participant Flow|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules a day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, Follow-up 30 days
708867|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708868|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708869|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708870|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708871|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708872|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708873|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708876|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708877|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708878|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708879|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708880|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708881|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708882|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708883|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708884|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708885|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708886|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708887|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708888|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708889|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708890|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708891|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708892|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708893|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708894|NCT01799720|O3|Outcome|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708895|NCT01799720|O2|Outcome|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708896|NCT01799720|O1|Outcome|Less Oxidized Oil and Diet|Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708897|NCT01799720|E3|Reported Event|Diet|Participants from group 3 only took diet. Follow-up 30 days.
708898|NCT01799720|E2|Reported Event|More Oxidized Oil and Diet|Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet. Follow-up 30 days.
708901|NCT01799590|B3|Baseline|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708902|NCT01799590|B2|Baseline|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708903|NCT01799590|B1|Baseline|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708904|NCT01799590|P3|Participant Flow|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708905|NCT01799590|P2|Participant Flow|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708906|NCT01799590|P1|Participant Flow|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708907|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708908|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708909|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708910|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708911|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708912|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708913|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708914|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708915|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708916|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708917|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708918|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
709085|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
708919|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708920|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708921|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708922|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708923|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708924|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708925|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708926|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
709008|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
708927|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708928|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708929|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708930|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708931|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708932|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708933|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708934|NCT01799590|O3|Outcome|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708935|NCT01799590|O2|Outcome|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708936|NCT01799590|O1|Outcome|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708937|NCT01799590|E3|Reported Event|Topiramate (JNS019) 100 mg|Participants allocated to JNS019 100 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day.Topiramate 50 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708938|NCT01799590|E2|Reported Event|Topiramate (JNS019) 50 mg|Participants allocated to JNS019 50 mg group in JNS019-JPN-02 trial were switched to the dose range from 50 mg per day to 100 mg per day. Topiramate 25 mg oral tablets were administered twice daily. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708939|NCT01799590|E1|Reported Event|Placebo/Topiramate (JNS019)|Participants allocated to placebo group in the JNS019-JPN-02 trial were switched to active treatment in the current study JNS019-JPN-03. Participants received topiramate oral tablets twice daily in the dose range of 50 milligram (mg) to 100 mg. Dose was increased or decreased maximum up to 200 mg per day as per Investigators discretion. Total duration of treatment was 52 weeks.
708940|NCT01799239|B1|Baseline|Overall Study|Describing baseline data for all subjects in the ITT population
708941|NCT01799239|P2|Participant Flow|First SenSura, Then Test Product|The subjects tested two products: In the first period the subjects tested the comparator SenSura. In the second period the subjects tested the newly developed ostomy bag called Test product
708942|NCT01799239|P1|Participant Flow|First Test Product; Then SenSura|The subjects tested two products: In the first period the subjects tested the newly developed ostomy bag called Test product. In the second period the subjects tested the comparator SenSura
708943|NCT01799239|O2|Outcome|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
708944|NCT01799239|O1|Outcome|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
708945|NCT01799239|E2|Reported Event|SenSura|CE marked and launched SenSura used in this investigation is a 1-piece open appliance with the intended use being to collect output from an ileostomy.
708946|NCT01799239|E1|Reported Event|Test Product|The new test product is a 1-piece open ostomy product with the intended use being collecting output from an ileostomy.
708947|NCT01799226|B3|Baseline|Total|Total of all reporting groups
708948|NCT01799226|B2|Baseline|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
709107|NCT01798264|P1|Participant Flow|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
708949|NCT01799226|B1|Baseline|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
708950|NCT01799226|P2|Participant Flow|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
708951|NCT01799226|P1|Participant Flow|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
708952|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
708953|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
708954|NCT01799226|O2|Outcome|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
708955|NCT01799226|O1|Outcome|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
708956|NCT01799226|E2|Reported Event|Test Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The test dentifrice was composed of 0.24% sodium fluoride 1100 ppm 0.243% (0.14% w/v fluoride ion) and triclosan 0.30% in combination with 2% polyvinyl methyl ether maleic acid copolymer as the active ingredients along with inactive ingredients (Colgate® Total® Clean Mint Paste).
708989|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
708957|NCT01799226|E1|Reported Event|Control Arm|Participants were randomly assigned to either the test (triclosan dentifrice) or control (fluoride dentifrice) arm of the study and to either the right or left stent side. The control dentifrice was composed of 0.76% sodium monofluorophosphate 1000 ppm (0.15% w/v fluoride ion) as the active ingredient along with inactive ingredients (Colgate® Cavity Protection Great Regular Flavor Fluoride Toothpaste).
708958|NCT01798992|B5|Baseline|Total|Total of all reporting groups
708959|NCT01798992|B4|Baseline|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
708960|NCT01798992|B3|Baseline|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
708961|NCT01798992|B2|Baseline|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
708962|NCT01798992|B1|Baseline|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
708963|NCT01798992|P4|Participant Flow|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
708964|NCT01798992|P3|Participant Flow|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
708965|NCT01798992|P2|Participant Flow|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
708966|NCT01798992|P1|Participant Flow|Non-failing Control|Patients with normal ejection fraction who underwent a single myocardial biopsy and received no β-blocker therapy
708967|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
708968|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin mesylate titrated to goals of 200 mg (metoprolol succinate) and 8 mg (doxazosin mesylate) by mouth daily for 18 months~Metoprolol succinate + doxazosin"
708969|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
708970|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
708971|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
708972|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
708973|NCT01798992|O3|Outcome|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
708974|NCT01798992|O2|Outcome|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
708975|NCT01798992|O1|Outcome|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
708976|NCT01798992|E3|Reported Event|Carvedilol|"Idiopathic dilated cardiomyopathy patients who were randomized to receive carvedilol titrated to a goal of 25 mg by mouth twice daily for 18 months~Carvedilol"
708977|NCT01798992|E2|Reported Event|Metoprolol Succinate + Doxazosin|"Idiopathic dilated cardiomyopathy patients who were randomized to receive metoprolol succinate and doxazosin titrated to a goal of 200 mg and 8 mg by mouth daily for 18 months~Metoprolol succinate + doxazosin"
708978|NCT01798992|E1|Reported Event|Metoprolol Succinate|"Idiopathic dilated cardiomyopathy patients randomized to metoprolol succinate titrated to a goal of 200 mg by mouth daily for 18 months~Metoprolol succinate"
708979|NCT01798966|B1|Baseline|SENSIMED Triggerfish|All patients included in the device group
708980|NCT01798966|P1|Participant Flow|SENSIMED Triggerfish|All patients included in the device group
708981|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
708982|NCT01798966|O1|Outcome|SENSIMED Triggerfish|All patients included in the device group
708983|NCT01798966|O1|Outcome|SENSIMED Triggerfish|SENSIMED Triggerfish worn for 24h
708984|NCT01798966|E1|Reported Event|SENSIMED Triggerfish|All patients included in the device group
708985|NCT01798927|B1|Baseline|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
708986|NCT01798927|P1|Participant Flow|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
708987|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
708988|NCT01798927|O1|Outcome|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
710341|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
708990|NCT01798927|E1|Reported Event|Ankle Foot Orthosis Fitting|"All participants will receive ankle foot orthosis or orthoses. Outcomes will be compared to pre-bracing findings.~Ankle foot orthosis: Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program."
708991|NCT01798706|B3|Baseline|Total|Total of all reporting groups
708992|NCT01798706|B2|Baseline|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
708993|NCT01798706|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
708994|NCT01798706|P2|Participant Flow|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
708995|NCT01798706|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg subcutaneously once daily (QD) for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
708996|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
708997|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
708998|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
708999|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709000|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709001|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709002|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709003|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709004|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709005|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709006|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709007|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709009|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709010|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709011|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709012|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709013|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709014|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709015|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709016|NCT01798706|O2|Outcome|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks.
709017|NCT01798706|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
709018|NCT01798706|E2|Reported Event|Placebo|Placebo (matched to lixisenatide) subcutaneously QD for 24 Weeks. (Median exposure: 169 days)
709019|NCT01798706|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg subcutaneously QD for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to Week 24. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.(Median exposure: 169 days)
709020|NCT01798485|B3|Baseline|Total|Total of all reporting groups
709021|NCT01798485|B2|Baseline|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709022|NCT01798485|B1|Baseline|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709023|NCT01798485|P2|Participant Flow|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709024|NCT01798485|P1|Participant Flow|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709025|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709026|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709027|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709028|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709029|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709030|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709031|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709032|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709033|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709034|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709035|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709036|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709037|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709038|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709039|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709040|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709041|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709108|NCT01798264|O4|Outcome|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
709109|NCT01798264|O3|Outcome|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
709042|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709043|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709044|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709045|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709046|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709047|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709048|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709049|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709050|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709051|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709052|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709053|NCT01798485|O2|Outcome|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709054|NCT01798485|O1|Outcome|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709055|NCT01798485|E2|Reported Event|Ganetespib and Docetaxel|Ganetespib (150 mg/m^2) and docetaxel (75 mg/m^2) were administered as separate 1-hour IV infusions on Day 1 of each 3-week treatment cycle. Administration of ganetespib preceded the administration of docetaxel. Ganetespib was administered again on Day 15 of each cycle.
709056|NCT01798485|E1|Reported Event|Docetaxel|Docetaxel (75 mg/m^2) was administered on Day 1 of a 3-week treatment cycle by 1-hour IV infusion.
709057|NCT01798394|B3|Baseline|Total|Total of all reporting groups
709083|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
709058|NCT01798394|B2|Baseline|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709059|NCT01798394|B1|Baseline|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709060|NCT01798394|P2|Participant Flow|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709061|NCT01798394|P1|Participant Flow|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709062|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709063|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709064|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709065|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709066|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709067|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709068|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709110|NCT01798264|O2|Outcome|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
709111|NCT01798264|O1|Outcome|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
709069|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709070|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709071|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709072|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709073|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709074|NCT01798394|O2|Outcome|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709075|NCT01798394|O1|Outcome|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709076|NCT01798394|E2|Reported Event|Placebo|"Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.~Placebo: Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4."
709077|NCT01798394|E1|Reported Event|Progesterone|"Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.~Progesterone: Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4."
709078|NCT01798316|B3|Baseline|Total|Total of all reporting groups
709079|NCT01798316|B2|Baseline|Standard of Care|"Standard of care pain management regimen including opioids~Standard of Care: No IV acetaminophen"
709080|NCT01798316|B1|Baseline|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
709081|NCT01798316|P2|Participant Flow|Standard of Care|"Standard of care pain management regimen including opioids~Standard of Care: without IV acetaminophen"
709082|NCT01798316|P1|Participant Flow|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes"
709086|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
709087|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
709088|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
709089|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
709090|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
709091|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
709092|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered before PACU admission~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
709093|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
709094|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
709095|NCT01798316|O2|Outcome|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV Acetaminophen"
709096|NCT01798316|O1|Outcome|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
709097|NCT01798316|E2|Reported Event|Standard of Care|"Standard of care pain management regimen including opioids administered on admission to PACU~No IV acetaminophen"
709098|NCT01798316|E1|Reported Event|IV Acetaminophen|"IV Acetaminophen administered on admission to PACU~IV Acetaminophen: Single dose, 1000g mg infusion over 15 minutes plus standard of care"
709099|NCT01798264|B5|Baseline|Total|Total of all reporting groups
709100|NCT01798264|B4|Baseline|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
709101|NCT01798264|B3|Baseline|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
709102|NCT01798264|B2|Baseline|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
709103|NCT01798264|B1|Baseline|10 Mcg/Day|ITCA 650 (exenatide in DUROS)
709104|NCT01798264|P4|Participant Flow|80 Mcg/Day|ITCA 650 (exenatide in DUROS)
709105|NCT01798264|P3|Participant Flow|40 Mcg/Day|ITCA 650 (exenatide in DUROS)
709106|NCT01798264|P2|Participant Flow|20 Mcg/Day|ITCA 650 (exenatide in DUROS)
709128|NCT01798134|B1|Baseline|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
709129|NCT01798134|P1|Participant Flow|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
709130|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
709131|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
709132|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
709133|NCT01798134|O1|Outcome|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
709134|NCT01798134|E1|Reported Event|DEB-TACE|"Transarterial Chemoembolization with TANDEM™ - DOX Microspheres (DEB-TACE)~Treatment: Lobes; Dosing: TANDEM™/Doxorubicin; Second Treatment:TANDEM™/Doxorubicin~TANDEM™"
709135|NCT01798004|B1|Baseline|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
709136|NCT01798004|P1|Participant Flow|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
709137|NCT01798004|O1|Outcome|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel Chemotherapy+ASCT+XRT
709138|NCT01798004|E1|Reported Event|All Patients|Induction with multi-agent chemotherapy followed by Consolidation with BuMel chemotherapy + ASCT + XRT
709139|NCT01797783|B3|Baseline|Total|Total of all reporting groups
709140|NCT01797783|B2|Baseline|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709141|NCT01797783|B1|Baseline|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709142|NCT01797783|P2|Participant Flow|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709143|NCT01797783|P1|Participant Flow|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709144|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709145|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709146|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709147|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709148|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709149|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709150|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709151|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709152|NCT01797783|O8|Outcome|FDP @ Day 30|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709153|NCT01797783|O7|Outcome|FDP @ Day 14|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709154|NCT01797783|O6|Outcome|FDP @ Day 3|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709155|NCT01797783|O5|Outcome|FDP @ Dispense|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709156|NCT01797783|O4|Outcome|DACP MF @ Day 30|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709157|NCT01797783|O3|Outcome|DACP MF @ Day 14|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709158|NCT01797783|O2|Outcome|DACP MF @ Day 3|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709159|NCT01797783|O1|Outcome|DACP MF @ Dispense|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709160|NCT01797783|O2|Outcome|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709161|NCT01797783|O1|Outcome|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709162|NCT01797783|E2|Reported Event|Focus® DAILIES® Progressives|Nelfilcon A multifocal contact lens worn for 30 days on a daily wear, daily disposable basis
709163|NCT01797783|E1|Reported Event|DAILIES® AquaComfort Plus® Multifocal|Nelfilcon A multifocal contact lens with comfort additive worn for 30 days on a daily wear, daily disposable basis
709164|NCT01797705|B1|Baseline|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
709165|NCT01797705|P1|Participant Flow|All Subjects|All enrolled subjects
709166|NCT01797705|O1|Outcome|All Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
709167|NCT01797705|E1|Reported Event|Evaluable Subjects|All subjects completing the one-night sleep study with evaluable results.
709168|NCT01797536|B5|Baseline|Total|Total of all reporting groups
709169|NCT01797536|B4|Baseline|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709170|NCT01797536|B3|Baseline|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709171|NCT01797536|B2|Baseline|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709172|NCT01797536|B1|Baseline|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709173|NCT01797536|P4|Participant Flow|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709174|NCT01797536|P3|Participant Flow|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709175|NCT01797536|P2|Participant Flow|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709176|NCT01797536|P1|Participant Flow|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709177|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709178|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709179|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709180|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709181|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709182|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709183|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709184|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709185|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709186|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709187|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709188|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709189|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709190|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709191|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709192|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709193|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709194|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709195|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709196|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709197|NCT01797536|O4|Outcome|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709198|NCT01797536|O3|Outcome|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709199|NCT01797536|O2|Outcome|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709200|NCT01797536|O1|Outcome|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709201|NCT01797536|E4|Reported Event|Healthy Participants|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants matched to the mean of all hepatic insufficiency participants for age, gender, and weight
709202|NCT01797536|E3|Reported Event|Severe Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with severe hepatic insufficiency, defined as a score of 10 to 15 on the Child-Pugh scale
709203|NCT01797536|E2|Reported Event|Moderate Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with moderate hepatic insufficiency, defined as a score of 7 to 9 on the Child-Pugh scale
709204|NCT01797536|E1|Reported Event|Mild Hepatic Insufficiency|Single oral dose of 5 x 10 mg capsules of elbasvir administered to participants with mild hepatic insufficiency, defined as a score of 5 to 6 on the Child-Pugh scale
709205|NCT01797445|B3|Baseline|Total|Total of all reporting groups
709206|NCT01797445|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709207|NCT01797445|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709208|NCT01797445|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709209|NCT01797445|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
709210|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709211|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709212|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709213|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709214|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709215|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709216|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709217|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709218|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709219|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709220|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709221|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709222|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709223|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709224|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709225|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709226|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709227|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709228|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709229|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709230|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709231|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709232|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709233|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709234|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709235|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709236|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709237|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709238|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709239|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709240|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709241|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709242|NCT01797445|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709503|NCT01794741|O1|Outcome|Dymista Nasal Spray|
709243|NCT01797445|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709244|NCT01797445|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
709245|NCT01797445|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
709246|NCT01797380|B3|Baseline|Total|Total of all reporting groups
709247|NCT01797380|B2|Baseline|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
709248|NCT01797380|B1|Baseline|Sugar Pill|Placebo
709249|NCT01797380|P2|Participant Flow|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
709250|NCT01797380|P1|Participant Flow|Sugar Pill|Placebo
709251|NCT01797380|O2|Outcome|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
709252|NCT01797380|O1|Outcome|Sugar Pill|Placebo
709253|NCT01797380|E2|Reported Event|Active Drug|Escitalopram tablet, 10mg, daily, 9 weeks.
709254|NCT01797380|E1|Reported Event|Sugar Pill|Placebo
709255|NCT01797328|B3|Baseline|Total|Total of all reporting groups
709256|NCT01797328|B2|Baseline|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
709257|NCT01797328|B1|Baseline|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
709258|NCT01797328|P2|Participant Flow|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
709259|NCT01797328|P1|Participant Flow|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
709260|NCT01797328|O2|Outcome|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
709261|NCT01797328|O1|Outcome|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering"
709262|NCT01797328|E2|Reported Event|to Avoid Feeling Cold|"warm arm~warm arm: To the best of ability avoid feeling cold during 6 weeks"
709263|NCT01797328|E1|Reported Event|Cold Provocation|"cold arm~cold arm: 1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering~no reported adverse events"
709264|NCT01797094|B3|Baseline|Total|Total of all reporting groups
709265|NCT01797094|B2|Baseline|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709266|NCT01797094|B1|Baseline|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709267|NCT01797094|P2|Participant Flow|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709410|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
709268|NCT01797094|P1|Participant Flow|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709269|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709270|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709271|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709272|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709273|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709274|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709275|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709276|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709277|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709278|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709340|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709279|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709280|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709281|NCT01797094|O2|Outcome|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709282|NCT01797094|O1|Outcome|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709283|NCT01797094|E2|Reported Event|Botulinum Toxin Type A (32U)|32 units (U) botulinum toxin Type A (total dose) per treatment. 12U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709284|NCT01797094|E1|Reported Event|Botulinum Toxin Type A (44U)|44 units (U) botulinum toxin Type A (total dose) per treatment. 24U injected into bilateral Crow's Feet Line areas and 20U injected into Frown Line area on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709285|NCT01797081|B5|Baseline|Total|Total of all reporting groups
709286|NCT01797081|B4|Baseline|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
709287|NCT01797081|B3|Baseline|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
709288|NCT01797081|B2|Baseline|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709289|NCT01797081|B1|Baseline|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709290|NCT01797081|P4|Participant Flow|Placebo/Botulinum Toxin Type A (12 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (12 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
709291|NCT01797081|P3|Participant Flow|Placebo/Botulinum Toxin Type A (24 U)|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180. Botulinum toxin Type A (24 U) injected into bilateral Crow's Feet Line areas at any additional treatments from day 180 onward. Based on retreatment criteria participants were eligible for up to 5 treatment cycles (2 Placebo + 3 botulinum toxin type A).
709292|NCT01797081|P2|Participant Flow|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709293|NCT01797081|P1|Participant Flow|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709294|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
709295|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709296|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709297|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
709298|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709299|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709300|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
709301|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709302|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709303|NCT01797081|O3|Outcome|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
709304|NCT01797081|O2|Outcome|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709305|NCT01797081|O1|Outcome|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709306|NCT01797081|E3|Reported Event|Placebo|Placebo (normal saline) one treatment injected into bilateral Crow's Feet Line areas on Day 1 and subsequent treatments if applicable until day 180.
709307|NCT01797081|E2|Reported Event|Botulinum Toxin Type A (12U)|12U botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709308|NCT01797081|E1|Reported Event|Botulinum Toxin Type A (24U)|24 units (U) botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas on Day 1. Based on retreatment criteria participants were eligible for up to 5 treatment cycles.
709309|NCT01797029|B3|Baseline|Total|Total of all reporting groups
709310|NCT01797029|B2|Baseline|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
709311|NCT01797029|B1|Baseline|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
709312|NCT01797029|P2|Participant Flow|Placebo|Inactive placebo will be identical to reconstituted Serum Institute of India, Ltd. (SIIL) LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
709313|NCT01797029|P1|Participant Flow|Vaccine|A single dose of Serum Institute of India, Ltd. (SIIL) Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
709314|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
709315|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
709316|NCT01797029|O2|Outcome|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
709317|NCT01797029|O1|Outcome|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
709318|NCT01797029|E2|Reported Event|Placebo|Inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
709319|NCT01797029|E1|Reported Event|Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 WHO Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
709411|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
709320|NCT01796977|B1|Baseline|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant was supposed to act as her own control (one breast to be treated with the test article, the other breast with the control article)."
709321|NCT01796977|P1|Participant Flow|OxyGenesys Dissolved Oxygen Dressing and Gauze Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~Standard Gauze Dressing: A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Each study participant acted as her own control (one breast of each participant was treated with OxyGenesys, while the other breast was treated with the standard dressing (control))."
709322|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
709323|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
709324|NCT01796977|O1|Outcome|All Available Study Participants|Each study participant was treated with OxyGenesys Dissolved Oxygen Dressing on one breast and standard gauze dressing on the opposite breast.
709325|NCT01796977|O2|Outcome|Standard Gauze Dressing|A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.
709326|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.
709327|NCT01796977|O2|Outcome|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
709328|NCT01796977|O1|Outcome|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
709329|NCT01796977|E2|Reported Event|Standard Gauze Dressing|"A sterile 4x4 covered by an adhesive Tegaderm will serve as the comparator for this study.~Standard Gauze Dressing"
709330|NCT01796977|E1|Reported Event|OxyGenesys Dissolved Oxygen Dressing|"OxyGenesys Dissolved Oxygen Dressing is a closed-cell foam wound dressing enriched with gaseous and dissolved oxygen for use in the management of wounds.~OxyGenesys Dissolved Oxygen Dressing"
709331|NCT01796964|B3|Baseline|Total|Total of all reporting groups
709332|NCT01796964|B2|Baseline|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709333|NCT01796964|B1|Baseline|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709334|NCT01796964|P2|Participant Flow|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709335|NCT01796964|P1|Participant Flow|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709336|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709337|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709342|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709343|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709344|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709345|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709346|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709347|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709348|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709349|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709350|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709351|NCT01796964|O2|Outcome|EYLEA|Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol
709352|NCT01796964|O1|Outcome|ESBA1008|ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
709353|NCT01796964|E3|Reported Event|EYLEA|All subjects who were randomized and received at least 1 IVT injection of Aflibercept
709354|NCT01796964|E2|Reported Event|ESBA 1008|All subjects who were randomized and received at least 1 IVT injection of ESBA1008 solution
709355|NCT01796964|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study
709356|NCT01796860|B1|Baseline|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
709357|NCT01796860|P1|Participant Flow|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
709358|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
710230|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
709359|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
709360|NCT01796860|O1|Outcome|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
709361|NCT01796860|E1|Reported Event|Ankle Foot Orthosis Group|"All persons in the study will be fit with the same AFO (Tamarack joint with adjustable check strap).~AFO: The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10."
709362|NCT01796548|B1|Baseline|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment. 'Number of participants analyzed for the baseline characteristic was intent-to-treat (ITT) population which included all randomly assigned participants who received at least 1 dose of study medication and fulfilled all eligibility criteria.'
709363|NCT01796548|P1|Participant Flow|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709364|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709365|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709713|NCT01791803|O4|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
709366|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709367|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709368|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709369|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709370|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709371|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709372|NCT01796548|O1|Outcome|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709412|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
709373|NCT01796548|E1|Reported Event|Oxybutynin|Participants received an initial dose of extended release (ER) oxybutynin chloride 10 milligram (mg) orally once daily, with an increment of 5 mg in the dosage, at an approximate 14-days interval to a maximum of 30 mg per day, until continence was achieved for the last 2 days of interval. Dose was decreased by 5 mg if there were intolerable side effects. The participants then continued the maintenance dose to 12-week treatment.
709374|NCT01796236|B3|Baseline|Total|Total of all reporting groups
709375|NCT01796236|B2|Baseline|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709376|NCT01796236|B1|Baseline|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709377|NCT01796236|P2|Participant Flow|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709378|NCT01796236|P1|Participant Flow|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709379|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709380|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709381|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709382|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709504|NCT01794741|E2|Reported Event|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
709383|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709384|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709385|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709386|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709387|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709388|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709389|NCT01796236|O2|Outcome|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709413|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
709414|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
709390|NCT01796236|O1|Outcome|Minimally Invasive Surgery and BA400|"This arm involves no softtissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments)."
709391|NCT01796236|E2|Reported Event|Traditional Surgery and BA300|"This arm involves traditional soft tissue reduction around the BA300 implant~Traditional surgery and BA300: The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm)."
709392|NCT01796236|E1|Reported Event|Minimally Invasive Surgery and BA400|"This arm involves no soft tissue reduction around the BA400 implant.~Minimally invasive surgery and BA400: The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments). The abutment is available in four different lengths (6, 8, 10 and 12 mm)"
709393|NCT01795937|B4|Baseline|Total|Total of all reporting groups
709394|NCT01795937|B3|Baseline|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
709395|NCT01795937|B2|Baseline|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
709396|NCT01795937|B1|Baseline|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
709397|NCT01795937|P3|Participant Flow|Treatment Sequence E_F (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E preceded treatment F.~Oral administration with 240 mL water."
709398|NCT01795937|P2|Participant Flow|Treatment Sequence C_D (Statins Part)|"The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part.~Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C preceded treatment D.~Oral administration with 240 mL water."
709399|NCT01795937|P1|Participant Flow|Treatment Sequence A_B (Itraconazole Part)|"The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part.~Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total).~Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment A directly preceded treatment B, without an intermittent washout period.~Oral administration with 240 mL water."
709400|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
709401|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
709402|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
709403|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
709404|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
709405|NCT01795937|O1|Outcome|Rosuvastatin|"Rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment E."
709406|NCT01795937|O2|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
709407|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
709408|NCT01795937|O2|Outcome|Rosuvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1.~Treatment F."
709409|NCT01795937|O1|Outcome|Atorvastatin+Faldaprevir|"Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment D."
709415|NCT01795937|O1|Outcome|Atorvastatin|"Atorvastatin (10 mg) was given as a single dose on Day 1.~Treatment C."
709416|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment B."
709417|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).~Treatment A."
709418|NCT01795937|O2|Outcome|Faldaprevir+Itraconazole|"Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total).~Treatment B."
709419|NCT01795937|O1|Outcome|Faldaprevir|"Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).~Treatment A."
709420|NCT01795937|E7|Reported Event|Faldaprevir + Rosuvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment F.~From the time of the combined administration of faldaprevir with rosuvastatin in treatment F until 1 day after the trial completion date."
709421|NCT01795937|E6|Reported Event|Faldaprevir + Atorvastatin (Statins Part)|"Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment D.~From the time of the combined administration of faldaprevir with atorvastatin in treatment D until 1 day after the trial completion date."
709422|NCT01795937|E5|Reported Event|Faldaprevir (Statins Part)|From the time of the first faldaprevir administration in treatment D or F until the combined administration of faldaprevir with atorvastatin or rosuvastatin in treatment D or F, respectively, or until 1 day after the trial completion date.
709423|NCT01795937|E4|Reported Event|Rosuvastatin (Statins Part)|"Rosuvastatin: 10 mg was given as a single dose on Day 1.~Treatment E.~From the time of the single dose rosuvastatin administration in treatment E until the time of the first faldaprevir administration in treatment F or until 1 day after the trial completion date."
709424|NCT01795937|E3|Reported Event|Atorvastatin (Statins Part)|"Atorvastatin: 10 mg was given as a single dose on Day 1.~Treatment C.~From the time of the single dose atorvastatin administration in treatment C until the time of the first faldaprevir administration in treatment D or until 1 day after the trial completion date of the respective subject."
709425|NCT01795937|E2|Reported Event|Faldaprevir+Itraconazole (Itraconazole Part)|"Faldaprevir: 120 mg once daily. Itraconazole: 200 mg once daily with a 200 mg twice daily loading dose on Day -3.~Treatment B."
709426|NCT01795937|E1|Reported Event|Faldaprevir (Itraconazole Part)|"Faldaprevir: 120 mg once daily with a 120 mg twice daily loading dose on Day -5.~Treatment A."
709427|NCT01795898|B1|Baseline|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709505|NCT01794741|E1|Reported Event|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
709428|NCT01795898|P1|Participant Flow|Fentanyl|Fentanyl transdermal (through the skin) patches releasing 12.5 microgram (mcg) of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709429|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709430|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709431|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709432|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709433|NCT01795898|O1|Outcome|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709434|NCT01795898|E1|Reported Event|Fentanyl|Fentanyl transdermal patches releasing 12.5 mcg of fentanyl were applied for 3 days. The patches were replaced every 3 days (Day 3, 7 and 10) with an increase in dose by 12.5 mcg to a maximum of 50 mcg.
709435|NCT01795716|B3|Baseline|Total|Total of all reporting groups
709436|NCT01795716|B2|Baseline|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
709437|NCT01795716|B1|Baseline|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period. In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
709438|NCT01795716|P2|Participant Flow|Glivec First, Then Mesylate Imatinib Capsule|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Glivec during the first study period. In the first phase of the multiple-dose administration, the groups were given Glivec 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Mesylate Imatinib Capsule was administered under the same protocol .
709439|NCT01795716|P1|Participant Flow|Mesylate Imatinib Capsule First, Then Glivec|Eligible subjects were randomly assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule during the first study period.In the first phase of the multiple-dose administration, the groups were given Mesylate Imatinib Capsule 400 mg once daily in the morning for ten consecutive days. After ten-day washout period, then Glivec was administered under the same protocol .
709440|NCT01795716|O2|Outcome|Glivec|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Glivec
709441|NCT01795716|O1|Outcome|Mesylate Imatinib Capsule|Eligible subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
709443|NCT01795716|E1|Reported Event|Mesylate Imatinib Capsule|Subjects were assigned to receive a single and multiple 400 mg oral dose Mesylate Imatinib Capsule
709444|NCT01795547|B3|Baseline|Total|Total of all reporting groups
709445|NCT01795547|B2|Baseline|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709446|NCT01795547|B1|Baseline|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709447|NCT01795547|P2|Participant Flow|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709448|NCT01795547|P1|Participant Flow|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709449|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709450|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709451|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709452|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709453|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709454|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709455|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709456|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709457|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709458|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709459|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709460|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709461|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709462|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709463|NCT01795547|O2|Outcome|Paliperidone|Paliperidone and paliperidone palmitate: Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by paliperidone palmitate IM injections every 4 weeks with last dose at Week 24 according to SmPC/USPI
709464|NCT01795547|O1|Outcome|Aripiprazole|Aripiprazole and aripiprazole once-monthly: Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection. Oral tablets will be taken for 2 more weeks after the 1st injection. Additional injections every 4 weeks until Week 24
709465|NCT01795547|O2|Outcome|Paliperidone|Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
710231|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
709466|NCT01795547|O1|Outcome|Aripiprazole|Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
709467|NCT01795547|E2|Reported Event|PALIPERIDONE|Safety data is based on all patients who received study medicine.
709468|NCT01795547|E1|Reported Event|ARIPIPRAZOLE|Safety data is based on all patients who received study medicine.
709469|NCT01795534|B1|Baseline|All Participants|Includes groups randomized to receive beetroot shot first and placebo first.
709470|NCT01795534|P2|Participant Flow|Placebo Shot Then Beetroot Shot|"Intervention: participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)~Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
709471|NCT01795534|P1|Participant Flow|Beetroot Shot Then Placebo Shot|"Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).~Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)"
709472|NCT01795534|O2|Outcome|Placebo Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)."
709473|NCT01795534|O1|Outcome|Beetroot Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
709474|NCT01795534|E2|Reported Event|Placebo Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml nitrate-depleted beetroot shot (~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)."
709475|NCT01795534|E1|Reported Event|Beetroot Shot|"Includes groups randomized to receive beetroot first and placebo first.~Data is for all participants following consumption of 1x70ml concentrated NO-3 shot of rich beetroot juice (~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK)."
709476|NCT01794949|B3|Baseline|Total|Total of all reporting groups
709477|NCT01794949|B2|Baseline|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709506|NCT01794455|B3|Baseline|Total|Total of all reporting groups
709478|NCT01794949|B1|Baseline|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709479|NCT01794949|P2|Participant Flow|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709480|NCT01794949|P1|Participant Flow|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709481|NCT01794949|O2|Outcome|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709482|NCT01794949|O1|Outcome|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709483|NCT01794949|E2|Reported Event|NIDDM Patients Receiving the Resolute Stent|Non–insulin-dependent diabetes mellitus (NIDDM) patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709484|NCT01794949|E1|Reported Event|Non-diabetic Patients Receiving the Resolute Stent|Non-diabetic patients undergoing percutaneous transluminal coronary intervention (PTCI) for treatment of de novo native vessel coronary artery disease with the Resolute drug eluting stent
709485|NCT01794936|B1|Baseline|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
709486|NCT01794936|P1|Participant Flow|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
709487|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
709488|NCT01794936|O1|Outcome|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
709489|NCT01794936|E1|Reported Event|VTI Probe or Non-Probe|Data per arm is not available. Columbia will never have access to this data.
709490|NCT01794845|B1|Baseline|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
709491|NCT01794845|P1|Participant Flow|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
709526|NCT01794000|B2|Baseline|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709492|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
709493|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
709494|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
709495|NCT01794845|O1|Outcome|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
709496|NCT01794845|E1|Reported Event|Erbitux, Taxotere, LD Fractionated RT|"Erbitux, Taxotere and Low Dose Fractionated Radiation Therapy (LDFRT):~Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.~Taxotere: 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.~Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy."
709497|NCT01794741|B3|Baseline|Total|Total of all reporting groups
709498|NCT01794741|B2|Baseline|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
709499|NCT01794741|B1|Baseline|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
709500|NCT01794741|P2|Participant Flow|Fluticasone Propionate Nasal Spray|"fluticasone propionate nasal spray 50mcg per spray per nostril twice a day~Fluticasone propionate nasal spray"
709501|NCT01794741|P1|Participant Flow|Dymista Nasal Spray|"azelastine 137mcg per spray/fluticasone propionate 50mcg per spray one spray per nostril twice a day for three months~Dymista Nasal Spray"
709507|NCT01794455|B2|Baseline|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709508|NCT01794455|B1|Baseline|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709509|NCT01794455|P2|Participant Flow|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709510|NCT01794455|P1|Participant Flow|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709511|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709512|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709513|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709514|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709515|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709516|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709517|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709518|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709519|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709520|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709521|NCT01794455|O2|Outcome|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709522|NCT01794455|O1|Outcome|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709523|NCT01794455|E2|Reported Event|Phase 2: Candesartan|"For subjects who do not remit to sertraline, they will receive candesartan for 12 weeks, with doses ranging from 4mg - 32mg daily.~Candesartan: 4mg - 32mg daily"
709524|NCT01794455|E1|Reported Event|Phase 1: Sertraline|"Eight-week trial of sertraline mono therapy, dosing ranging from 50mg- 200mg daily.~Sertraline: 50mg - 200mg daily"
709525|NCT01794000|B3|Baseline|Total|Total of all reporting groups
710232|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
709527|NCT01794000|B1|Baseline|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709528|NCT01794000|P2|Participant Flow|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709529|NCT01794000|P1|Participant Flow|Prasugrel|Participants (Pts.) will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709530|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709531|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709532|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709533|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709534|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709535|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709536|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709537|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709538|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709539|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709540|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709541|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709542|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709543|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709544|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709545|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709546|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709547|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709746|NCT01791465|B1|Baseline|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide
709548|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709549|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709550|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709551|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709552|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709553|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709554|NCT01794000|O2|Outcome|Placebo|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709555|NCT01794000|O1|Outcome|Prasugrel|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709556|NCT01794000|E3|Reported Event|Prasugrel - Open Label Phase|Participants who continued to meet eligibility criteria, who were not permanently discontinued from study drug, and who concluded their participation in 24 months of double blind treatment were to be considered eligible to enter the open label phase.
709557|NCT01794000|E2|Reported Event|Placebo - Double Blind Phase|Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
709579|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709558|NCT01794000|E1|Reported Event|Prasugrel - Double Blind Phase|Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg daily, not to exceed 10 mg daily.
709559|NCT01793688|B1|Baseline|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
709560|NCT01793688|P1|Participant Flow|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
709561|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
709562|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
709563|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
709564|NCT01793688|O1|Outcome|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
709565|NCT01793688|E1|Reported Event|Sulbactam Sodium/Ampicillin Sodium|The usual adult dosage was 6 g daily (strength) in two divided doses as sulbactam sodium/ampicillin sodium given by intravenous injection or intravenous drip infusion. In cases of severe infection, the dose could be increased with a maximum dose of 3 g (strength) four times daily (12 g [strength] daily).
709566|NCT01793285|B1|Baseline|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709567|NCT01793285|P1|Participant Flow|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 milligram (mg) weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709568|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709569|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709570|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709571|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709572|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709573|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709574|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709575|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709576|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709577|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709578|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
710192|NCT01788163|B2|Baseline|Taiwan|Subjects in Taiwan that meet I/E and population criteria
709580|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709581|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709582|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709583|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709584|NCT01793285|O1|Outcome|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709585|NCT01793285|E1|Reported Event|Etanercept|Participants who completed LoadET study 0881A3-102090 (NCT00873730) and received either etanercept 50 mg weekly subcutaneously, etanercept 100 mg weekly subcutaneously, another drug, or abandoned medication as per standard clinical practice were observed retrospectively for 3 years.
709586|NCT01792986|B1|Baseline|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
709587|NCT01792986|P1|Participant Flow|Water-only 24-hour Fasting Once Per Week for 6 Weeks|water-only 24-hour fasting once per week for 6 weeks
709588|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
709589|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
709590|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
709591|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
709592|NCT01792986|O1|Outcome|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
709593|NCT01792986|E1|Reported Event|Water-only 24-hour Fasting Once Per Week for 6 Weeks|
709594|NCT01792830|B8|Baseline|Total|Total of all reporting groups
709595|NCT01792830|B7|Baseline|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
709596|NCT01792830|B6|Baseline|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
709597|NCT01792830|B5|Baseline|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
709598|NCT01792830|B4|Baseline|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen.
709599|NCT01792830|B3|Baseline|No Diabetes/ Insulin|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin.
709600|NCT01792830|B2|Baseline|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
709601|NCT01792830|B1|Baseline|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
709602|NCT01792830|P7|Participant Flow|Diabetic/Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
709603|NCT01792830|P6|Participant Flow|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
709604|NCT01792830|P5|Participant Flow|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
709605|NCT01792830|P4|Participant Flow|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
709606|NCT01792830|P3|Participant Flow|No Diabetes Insulin Group|Patients with an HbA1c < 7% and persistent hyperglycemia will be given subcutaneous (SC) insulin therapy in the hospital will be discharged on oral metformin.
709607|NCT01792830|P2|Participant Flow|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
709608|NCT01792830|P1|Participant Flow|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, were discharged from the hospital without any antidiabetic therapy.
709609|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on glulisine, a rapid-acting insulin to be taken before meals.
709610|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + IInsulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% will be discharged on oral metformin and glargine insulin to be taken daily at the same time of day; or, basal bolus insulin regimen.
709611|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
709612|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission will be discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
709613|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin will be discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin is given in divided doses with meals.
709614|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient. Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
709615|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% will be discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin: Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.~Patients without a history of diabetes and admission HbA1C < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.~Treatment naïve patients with an HbA1C between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
709616|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
709617|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
709748|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709618|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital will be discharged on no antidiabetic therapy.
709619|NCT01792830|O10|Outcome|Diabetic HbA1C >9% Glulisine|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on glulisine, a rapid-acting insulin taken before meals.
709620|NCT01792830|O9|Outcome|Diabetic HbA1C >9% Metformin + Insulin|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C > 9% were discharged on oral metformin and glargine insulin taken daily at the same time of day; or, basal bolus insulin regimen.
709621|NCT01792830|O8|Outcome|Diabetic HbA1C 7%-9% Glargine|Patients with HbA1C between 7% and 9% requiring subcutaneous insulin therapy were discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose given once a day at the same time every day.
709622|NCT01792830|O7|Outcome|Diabetic HbA1C 7%-9% Metformin + Glargine|Patients treated with combination of oral antidiabetic agents and basal insulin (NPH, glargine, detemir) prior to admission were discharged on pre-admission oral antidiabetic therapy plus a single dose of glargine insulin or with basal bolus insulin regimen at 50% of total daily hospital dose.
709623|NCT01792830|O6|Outcome|Diabetic HbA1C 7%- 9% Metformin|Subjects requiring coronary artery bypass graft surgery with a history of diabetes with HbA1C between 7% and 9% requiring in hospital subcutaneous insulin were discharged on oral metformin and a single dose of glargine at 50% of total daily hospital dose. Metformin was given in divided doses with meals.
709624|NCT01792830|O5|Outcome|Diabetic HbA1C <7% Glargine|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to glargine and identify the minimum effective dose for the patient. Glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar levels."
709625|NCT01792830|O4|Outcome|Diabetic HbA1C <7% Metformin|"Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1C <7% were discharged on their same outpatient antidiabetic regimen (diet, oral antidiabetic agents and/or insulin).~Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels were used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient."
709626|NCT01792830|O3|Outcome|No Diabetes Insulin Group|Patients with an A1C < 7% and persistent hyperglycemia requiring SC insulin therapy in the hospital were discharged on oral metformin.
709627|NCT01792830|O2|Outcome|No Diabetes, Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1C <7% were discharged on oral metformin.
709628|NCT01792830|O1|Outcome|Control HbA1C < 7%|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1C <7% not requiring subcutaneous insulin in the hospital were discharged on no antidiabetic therapy.
709681|NCT01791972|B1|Baseline|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
709629|NCT01792830|E6|Reported Event|Diabetic/ Glargine and Glulisine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on basal bolus regimen at the same inpatient total daily insulin dose and glulisine before meals.
709630|NCT01792830|E5|Reported Event|Diabetic/ Metformin and 80-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c >9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 80% of the total daily hospital dose or with a basal bolus regimen at the same inpatient total daily dose.
709631|NCT01792830|E4|Reported Event|Diabetic/ Metformin and 50-Glargine|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c between 7% and 9% requiring subcutaneous insulin, will be discharged on oral metformin and a single dose of basal (glargine) insulin at 50% of the total daily hospital dose.
709632|NCT01792830|E3|Reported Event|Diabetic/ Antidiabetic Regimen|Subjects requiring coronary artery bypass graft surgery (CABG) with a history of diabetes with HbA1c <7% will be discharged on their same outpatient antidiabetic regimen.
709633|NCT01792830|E2|Reported Event|No Diabetes/ Metformin Only|Subjects requiring coronary artery bypass graft (CABG) surgery with no history of diabetes with HbA1c <7% and persistent hyperglycemia requiring subcutaneous insulin, will be discharged on oral metformin.
709634|NCT01792830|E1|Reported Event|Control|Subjects not requiring coronary artery bypass graft surgery (CABG) with no history of diabetes with HbA1c level <7% not requiring subcutaneous insulin, will be discharged from the hospital without any antidiabetic therapy.
709635|NCT01792635|B4|Baseline|Total|Total of all reporting groups
709636|NCT01792635|B3|Baseline|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709637|NCT01792635|B2|Baseline|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709638|NCT01792635|B1|Baseline|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709639|NCT01792635|P3|Participant Flow|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709747|NCT01791465|P1|Participant Flow|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709640|NCT01792635|P2|Participant Flow|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709641|NCT01792635|P1|Participant Flow|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709642|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709643|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709644|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709645|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709646|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709647|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709648|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709649|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709650|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709651|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709652|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709653|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709654|NCT01792635|O2|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709655|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709656|NCT01792635|O1|Outcome|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709657|NCT01792635|O1|Outcome|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709658|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709659|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709660|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709661|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709698|NCT01791894|E1|Reported Event|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV"
709699|NCT01791803|B5|Baseline|Total|Total of all reporting groups
709662|NCT01792635|O1|Outcome|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709663|NCT01792635|E3|Reported Event|Placebo - Part B|Participants received placebo twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709664|NCT01792635|E2|Reported Event|PF-05175157 200 mg Twice a Day - Part B|Participants received PF-05175157 200 mg twice a day at approximately 08:00 immediately before the morning meal, and at approximately 18:00 before the dinner meal. The treatment period was 6 weeks.
709665|NCT01792635|E1|Reported Event|All Participants in Part A|Participants underwent 2 step euglycemic hyperinsulinemic clamp procedure and were infused with insulin according to a specified algorithm to reduce plasma glucose levels to approximately 100 milligram (mg)/deciliter (dL). In Step 1 of the clamp, each individual’s insulin infusion rate during the last 2 hours of the overnight infusion was increased by 10 mU/square meter (m^2)/minute (min). During Step 2, all participants received an insulin infusion, at a rate of 120 mU/m^2/min.
709666|NCT01792518|B3|Baseline|Total|Total of all reporting groups
709667|NCT01792518|B2|Baseline|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709668|NCT01792518|B1|Baseline|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709669|NCT01792518|P2|Participant Flow|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709670|NCT01792518|P1|Participant Flow|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709671|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709672|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709673|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709674|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709675|NCT01792518|O2|Outcome|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709676|NCT01792518|O1|Outcome|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709677|NCT01792518|E2|Reported Event|Linagliptin 5 mg|Patients received 1 tablet of Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709678|NCT01792518|E1|Reported Event|Placebo|Patients received 1 matching placebo tablet to Linagliptin 5 mg, administered orally, once every day for 24 weeks during the double blind treatment period.
709679|NCT01791972|B3|Baseline|Total|Total of all reporting groups
709680|NCT01791972|B2|Baseline|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
709682|NCT01791972|P2|Participant Flow|Placebo Spiromax / Albuterol Spiromax|Placebo Spiromax, (2 inhalations), single dose on Day 1. Albuterol Spiromax 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on approximately Day 7.
709683|NCT01791972|P1|Participant Flow|Albuterol Spiromax / Placebo Spiromax|Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation), single dose on Day 1. Placebo Spiromax (2 inhalations), single dose on approximately Day 7.
709684|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
709685|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
709686|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
709687|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
709688|NCT01791972|O2|Outcome|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
709689|NCT01791972|O1|Outcome|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
709690|NCT01791972|E2|Reported Event|Placebo Spiromax|Single dose of Placebo Spiromax (2 inhalations)
709691|NCT01791972|E1|Reported Event|Albuterol Spiromax 180 mcg|Single dose of Albuterol Spiromax, 180 mcg (2 inhalations of 90 mcg/inhalation)
709692|NCT01791894|B1|Baseline|Treatment (Arsenic Trioxide)|arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days
709693|NCT01791894|P1|Participant Flow|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
709694|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
709695|NCT01791894|O1|Outcome|IV ATO|5 subjects will be treated with arsenic trioxide at 0.3 mg/kg daily via a 2 hour intravenous infusion for 5 days every 28 days (+/- 5 days) for a total of 3 cycles.
709696|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV~laboratory biomarker analysis: Correlative studies"
709697|NCT01791894|O1|Outcome|Treatment (Arsenic Trioxide)|"Patients receive arsenic trioxide IV over 2 hours on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~arsenic trioxide: Given IV~laboratory biomarker analysis: Correlative studies"
709700|NCT01791803|B4|Baseline|Self-Quit Group|Patients were given brief counseling during hospitalization and were not contacted until 26 weeks after hospitalization. They received no telephone contact and or counseling after discharge.
709701|NCT01791803|B3|Baseline|Hypnotherapy and Nicotine Replacement|patients recieved both a similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.
709702|NCT01791803|B2|Baseline|Nicotine Replacement Therapy|Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays, self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.
709703|NCT01791803|B1|Baseline|Hypnotherapy|Patients received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use . They also received counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.
709704|NCT01791803|P4|Participant Flow|Self-Quit Group|patients will be given brief counseling during hospitalization and will not be contacted until 26 weeks after hospitalization.
709705|NCT01791803|P3|Participant Flow|Hypnotherapy and Nicotine Replacement|"The group will recieve similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nictotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
709706|NCT01791803|P2|Participant Flow|Nicotine Replacement Therapy|"Patients will recieve a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients will receive self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
709707|NCT01791803|P1|Participant Flow|Hypnotherapy|"Patients admitted with a cardiopulmonary illness will receive a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
709708|NCT01791803|O1|Outcome|Smoking Abstinence Rates at 12 and 26 Weeks|Smoking status at follow-up time at 12 and 26 weeks by diagnosis status (cardiac vs. pulmonary)
709709|NCT01791803|O4|Outcome|Self-Quit Group|patients were given brief counseling during hospitalization and were not be contacted until 26 weeks after hospitalization.
709710|NCT01791803|O3|Outcome|Hypnotherapy and Nicotine Replacement|"The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
709711|NCT01791803|O2|Outcome|Nicotine Replacement Therapy|"Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
709712|NCT01791803|O1|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They will also recieve self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
709714|NCT01791803|O3|Outcome|Hypnotherapy and Nicotine Replacement|"The group received similar hypnotherapy session and tape, similar brochure and counseling protocol, as well as free nicotine replacement supplies for a month after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge~Nicotine: free one month supply after hospital discharge"
709715|NCT01791803|O2|Outcome|Nicotine Replacement Therapy|"Patients received a free one month supply of Nicotine replacement therapy to include patches and Gum, lozenges or sprays. Patients also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after hospitalization.~Nicotine: free one month supply after hospital discharge"
709716|NCT01791803|O1|Outcome|Hypnotherapy|"Patients admitted with a cardiopulmonary illness received a 90 minute free hypnotherapy session within 2 weeks of discharge, and a standardized tape for smoking cessation and relaxation for continued use after the session. They also received self-help brochures, and counseling during hospitalization and by telephone at 1,2,4,8 and 12 weeks after discharge.~hypnotherapy: One 90 minute session within 2 weeks of hospital discharge"
709717|NCT01791803|E4|Reported Event|Self-Quit Group|patient who decided to quit on their own
709718|NCT01791803|E3|Reported Event|Hypnotherapy and Nicotine Replacement|Patients receiving hypnotherapy and nicotine supply
709719|NCT01791803|E2|Reported Event|Nicotine Replacement Therapy|Patients receiving a free months supply of nicotine
709720|NCT01791803|E1|Reported Event|Hypnotherapy|patients receiving a free intensive session of hypnotherapy within 2 weeks of hospitalization
709721|NCT01791725|B4|Baseline|Total|Total of all reporting groups
709722|NCT01791725|B3|Baseline|Placebo|"Placebo BID~Placebo"
709723|NCT01791725|B2|Baseline|ELND005 QD|"ELND005 250 mg QD~ELND005"
709724|NCT01791725|B1|Baseline|ELND005 BID|"ELND005 250 mg BID~ELND005"
709725|NCT01791725|P3|Participant Flow|Placebo|"Placebo BID~Placebo"
709726|NCT01791725|P2|Participant Flow|ELND005 QD|"ELND005 250 mg QD~ELND005"
709727|NCT01791725|P1|Participant Flow|ELND005 BID|"ELND005 250 mg BID~ELND005"
709728|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
709729|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
709730|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
709731|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
709732|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
709733|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
709734|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
709735|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
709736|NCT01791725|O1|Outcome|ELND005 BID|"ELND005 250 mg BID~ELND005"
709737|NCT01791725|O3|Outcome|Placebo|"Placebo BID~Placebo"
709738|NCT01791725|O2|Outcome|ELND005 QD|"ELND005 250 mg QD~ELND005"
709749|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709750|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709751|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709752|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709753|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709754|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709755|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709756|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709757|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709758|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709759|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709760|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709761|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709762|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709763|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709764|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
710193|NCT01788163|B1|Baseline|China|Subjects in China that meet I/E and population criteria.
709765|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709766|NCT01791465|O1|Outcome|Bydureon Treatment|"Treatment for 16 weeks with extended-release Exenatide (Bydureon)~extended-release exenatide: Single arm study - 2mg Bydureon every 7 days x 16 weeks"
709767|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709768|NCT01791465|O1|Outcome|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709769|NCT01791465|E1|Reported Event|Bydureon Treatment|Treatment for 16 weeks with extended-release Exenatide (Bydureon) extended-release exenatide. N=6 HIV-infected persons
709770|NCT01791413|B3|Baseline|Total|Total of all reporting groups
709771|NCT01791413|B2|Baseline|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
709772|NCT01791413|B1|Baseline|No Depot Medroxyprogesterone Acetate|
709773|NCT01791413|P2|Participant Flow|Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
709774|NCT01791413|P1|Participant Flow|No Depot Medroxyprogesterone Acetate|
709775|NCT01791413|O4|Outcome|3 mo. Post op: Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
709776|NCT01791413|O3|Outcome|3 mo. Post op: No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 3-month post operation
709777|NCT01791413|O2|Outcome|2 wk Post op:Depot Medroxyprogesterone Acetate|depot medroxyprogesterone acetate : DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
709778|NCT01791413|O1|Outcome|2 wk Post op : No Depot Medroxyprogesterone Acetate|Percentage changes of serum Anti-Mullerian hormone (AMH) at 2-week post operation
709779|NCT01791413|E1|Reported Event|DMPA|
709780|NCT01791205|B3|Baseline|Total|Total of all reporting groups
709781|NCT01791205|B2|Baseline|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709782|NCT01791205|B1|Baseline|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709783|NCT01791205|P2|Participant Flow|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709784|NCT01791205|P1|Participant Flow|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received tocilizumab (TCZ) as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709785|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709786|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709787|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709788|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709789|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709790|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709791|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709809|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709792|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709793|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709794|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709795|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709796|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709797|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709798|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709799|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709800|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709801|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709802|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709803|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709804|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709805|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709806|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709807|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709808|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
710000|NCT01790516|O1|Outcome|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
709810|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709811|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709812|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709813|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709814|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709815|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709816|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709817|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709818|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709819|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709820|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709821|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709822|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709823|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709824|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709825|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709826|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709827|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709828|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709829|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709830|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709908|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709831|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709832|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with DMARDs in the 12 months prior to study entry were observed for Phase I.
709833|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709834|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709835|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709836|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709837|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709838|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709839|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709840|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709841|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709950|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709842|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709843|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709844|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709845|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709846|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709847|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709848|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709849|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709850|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
710194|NCT01788163|P9|Participant Flow|Russia|Subjects in Russia that meet I/E and population criteria
709851|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709852|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709853|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709854|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709855|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709856|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709857|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709858|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709859|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709860|NCT01791205|O2|Outcome|Combination Therapy|Eligible participants who received any biologic drug in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the 12 months prior to study entry were observed for Phase I.
709861|NCT01791205|O1|Outcome|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709881|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709862|NCT01791205|E1|Reported Event|Monotherapy|Eligible participants who received any biologic drug as a monotherapy in the 12 months prior to the study entry were observed for Phase I. Participants who were enrolled in Phase I and received TCZ as a monotherapy were observed for 18 months from the first infusion of TCZ in Phase II, where TCZ was prescribed according to the approved product information, local treatment guidelines and/or routine clinical practice.
709863|NCT01791153|B5|Baseline|Total|Total of all reporting groups
709864|NCT01791153|B4|Baseline|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709865|NCT01791153|B3|Baseline|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709866|NCT01791153|B2|Baseline|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709867|NCT01791153|B1|Baseline|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709868|NCT01791153|P4|Participant Flow|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709869|NCT01791153|P3|Participant Flow|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709870|NCT01791153|P2|Participant Flow|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection every 2 weeks (q2w) (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709930|NCT01791127|O1|Outcome|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
710247|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
709871|NCT01791153|P1|Participant Flow|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 milligrams (mg) as subcutaneous (SC) injection every week (qw) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709872|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709873|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709874|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709875|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709876|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709877|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709878|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709879|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709880|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
710018|NCT01790490|E1|Reported Event|Ketamine 0.41 (K1)|Ketamine 0.41 (K1) over 52 minutes
709882|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709883|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709884|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709885|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709886|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709887|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709888|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709889|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709996|NCT01790516|B1|Baseline|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
709890|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709891|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709892|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709893|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709894|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709895|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709896|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709897|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709898|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709899|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709900|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709901|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709902|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709903|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709904|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709905|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709906|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709907|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
710162|NCT01788215|B2|Baseline|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
709909|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709910|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709911|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709912|NCT01791153|O4|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709913|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709914|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709915|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709916|NCT01791153|O3|Outcome|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709917|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709918|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709949|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
710019|NCT01790178|B3|Baseline|Total|Total of all reporting groups
709919|NCT01791153|O3|Outcome|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709920|NCT01791153|O2|Outcome|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709921|NCT01791153|O1|Outcome|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709922|NCT01791153|E4|Reported Event|Part 1: Placebo + 52 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses for 52 weeks.
709923|NCT01791153|E3|Reported Event|Part 1: Placebo + 26 Weeks Prednisone Taper|Participants received tocilizumab placebo as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709924|NCT01791153|E2|Reported Event|Part 1: Tocilizumab q2w + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection q2w (and tocilizumab placebo q2w starting from Week 2) up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709925|NCT01791153|E1|Reported Event|Part 1: Tocilizumab qw + 26 Weeks Prednisone Taper|Participants received tocilizumab at a dose of 162 mg as SC injection qw up to 52 weeks along with prednisone and/or prednisone placebo according to the protocol-defined schedule. Participants received prednisone tapering oral daily doses during the first 26 weeks and prednisone placebo from Week 26 up to Week 52.
709926|NCT01791127|B1|Baseline|Pre-Market Study Cohort|All subjects who were implanted with a Siello lead (or had an implant attempt) on or before the implant date of the last subject to reach the 12-month follow-up time point.
709927|NCT01791127|P1|Participant Flow|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
709928|NCT01791127|O1|Outcome|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
709929|NCT01791127|O1|Outcome|Pacemaker Therapy|Patients with a market-released BIOTRONIK pacemaker system including one or two Siello S leads.
710573|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
709931|NCT01791127|E1|Reported Event|Pre-Market Study Cohort|"All Cause Mortality:~The total number of subjects includes all subjects who were implanted with a Siello lead (or had an implant attempt) on or before the implant date of the last subject to reach the 12-month follow-up time point (total Pre-Market Study Cohort)~Adverse Events:~The total number of subjects includes all subjects from the Pre-Market Study cohort who experienced any adverse event and/or reached the 12-month follow-up time point"
709932|NCT01790828|B1|Baseline|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709933|NCT01790828|P1|Participant Flow|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709934|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709935|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709936|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709937|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709938|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709939|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709940|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709941|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709942|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709943|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709944|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709945|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709946|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709947|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709948|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709951|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709952|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709953|NCT01790828|O1|Outcome|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709954|NCT01790828|E1|Reported Event|Xyntha|Non-interventional, observational study of participants who were prescribed and received at least 1 dose of Xyntha 250, 500, 1000, or 2000 IU.
709955|NCT01790750|B1|Baseline|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
709956|NCT01790750|P1|Participant Flow|PES First, Then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
709957|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
709958|NCT01790750|O1|Outcome|PES First, Then FFES|A 5-minutePocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
709959|NCT01790750|E1|Reported Event|PES First, Then FFES|A 5-minute Pocket Echocardiography System Scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
709960|NCT01790685|B3|Baseline|Total|Total of all reporting groups
709961|NCT01790685|B2|Baseline|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
709962|NCT01790685|B1|Baseline|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
709963|NCT01790685|P2|Participant Flow|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
709964|NCT01790685|P1|Participant Flow|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
709965|NCT01790685|O2|Outcome|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
709966|NCT01790685|O1|Outcome|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
709967|NCT01790685|E2|Reported Event|BRVO|"Branch Retinal Vein Occlusion~dexamethasone implant"
709968|NCT01790685|E1|Reported Event|CRVO|"Central Retinal Vein Occlusion~dexamethasone implant"
709969|NCT01790633|B3|Baseline|Total|Total of all reporting groups
709970|NCT01790633|B2|Baseline|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
709971|NCT01790633|B1|Baseline|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
709972|NCT01790633|P2|Participant Flow|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
709973|NCT01790633|P1|Participant Flow|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
709974|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
709975|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
709976|NCT01790633|O1|Outcome|Screened for Eligibility|Individuals who were screened for eligibility, prior to being considered for randomization.
709977|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
709978|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
709979|NCT01790633|O2|Outcome|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
709980|NCT01790633|O1|Outcome|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
710020|NCT01790178|B2|Baseline|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
709981|NCT01790633|E2|Reported Event|Rapid Testing|"HBV, HCV, and HIV infection status determined by a rapid test~Rapid Test: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day."
709982|NCT01790633|E1|Reported Event|Standard Testing With ELISA|"HBV, HCV, and HIV infection status determined by enzyme-linked immuno-assay (ELISA).~ELISA: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days)."
709983|NCT01790581|B3|Baseline|Total|Total of all reporting groups
709984|NCT01790581|B2|Baseline|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
709985|NCT01790581|B1|Baseline|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
709997|NCT01790516|P2|Participant Flow|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
709998|NCT01790516|P1|Participant Flow|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
709999|NCT01790516|O2|Outcome|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
709986|NCT01790581|P2|Participant Flow|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised sessions. Exercises and repetitions per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
709987|NCT01790581|P1|Participant Flow|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
709988|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
709989|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
710021|NCT01790178|B1|Baseline|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710022|NCT01790178|P2|Participant Flow|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
710340|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
709990|NCT01790581|O2|Outcome|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
709991|NCT01790581|O1|Outcome|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
709992|NCT01790581|E2|Reported Event|Balance Training w/ STARS|"Balance Training: This is a 4-week supervised balance training program. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. Exercises and reps that will be performed per training session will include: 1) hop to stabilization (10 reps per direction), 2) hop to stabilization and reach (5 reps per direction), 3) unanticipated hop to stabilization (3 reps), 4) progressive single limb stance (3 reps), and 5) progressive single limb stance with eyes closed (3 reps).~STARS: The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques will be applied in the same order for all sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization."
709993|NCT01790581|E1|Reported Event|Balance Training|Balance Training: This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
709994|NCT01790516|B3|Baseline|Total|Total of all reporting groups
709995|NCT01790516|B2|Baseline|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
710001|NCT01790516|E2|Reported Event|Cetuximab|"Intensity modulated radiation therapy with concurrent cetuximab~cetuximab plus radiation therapy: Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation."
710002|NCT01790516|E1|Reported Event|Cisplatin|"Intensity modulated radiation with concurrent cisplatin~platinum plus radiation: Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy"
710003|NCT01790490|B4|Baseline|Total|Total of all reporting groups
710004|NCT01790490|B3|Baseline|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
710005|NCT01790490|B2|Baseline|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
710006|NCT01790490|B1|Baseline|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
710007|NCT01790490|P3|Participant Flow|K1, K2, and LZP|K1 followed by K2 and then LZP. Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
710008|NCT01790490|P2|Participant Flow|LZP, K1, and K2|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
710009|NCT01790490|P1|Participant Flow|K1, LZP, and K2|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
710010|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP) Following K1|Infusions are separated by 48 hours. This allows for within-subject comparison of the post-K1 additive effects of K2 and LZP.
710011|NCT01790490|O2|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|LZP followed by K1 and then K2. Infusions are separated by 48 hours. This order allows for comparison between LZP and K1.
710012|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|Ketamine 0.41 (K1) followed by lorazepam (LZP) and then ketamine 0.71. Infusions are separated by 48 hours. This ordering allows for comparison between K1 and LZP, and between the post-K1 additive effects of LZP and K2.
710013|NCT01790490|O3|Outcome|Lorazepam Infusion 2 mg/kg Over 52 Minutes (LZP)|"Lorazepam 2 mg infused over 52 minutes (LZP)~Lorazepam 2 mg: 52 minute infusion of lorazepam 2 mg. This serves as an active control."
710014|NCT01790490|O2|Outcome|Ketamine Infusion 0.71 mg/kg Over 52 Minutes (K2)|"Ketamine 0.71 mg/kg infused over 52 min (K2)~Ketamine 0.71 mg/kg: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings."
710015|NCT01790490|O1|Outcome|Ketamine Infusion 0.41 mg/kg Over 52 Minutes (K1)|"Ketamine 0.41 mg/kg infused over 52 min (K1)~Ketamine 0.41 mg/kg: 52 minute iv infusion of ketamine 0.41 mg/kg"
710016|NCT01790490|E3|Reported Event|Ketamine 0.71 (K2)|Ketamine 0.71 mg/kg over 52 minutes (K2)
710017|NCT01790490|E2|Reported Event|Lorazepam 2 mg (LZP)|Lorazepam 2 mg (LZP) over 52 minutes
710023|NCT01790178|P1|Participant Flow|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710024|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
710025|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710026|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
710027|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710028|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
710029|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710030|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
710031|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710032|NCT01790178|O2|Outcome|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
710033|NCT01790178|O1|Outcome|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710034|NCT01790178|E2|Reported Event|Non-Ultrasound Guided Group|The control group will have non-ultrasound guided biopsies performed, which is the current standard of care.
710035|NCT01790178|E1|Reported Event|Ultrasound Guided Biopsy|"Ultrasound guided biopsy will be used in all patients.~Ultrasound: The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes."
710036|NCT01789970|B3|Baseline|Total|Total of all reporting groups
710037|NCT01789970|B2|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered extended-release hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710038|NCT01789970|B1|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710039|NCT01789970|P3|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710040|NCT01789970|P2|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710041|NCT01789970|P1|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
710042|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710043|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710044|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710045|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710046|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710047|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710219|NCT01788163|O2|Outcome|China-Mutation Status Negative|Subjects in China that meet I/E and population criteria, who had a Negative Mutation Status.
710048|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710049|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710050|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710051|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710052|NCT01789970|O3|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710053|NCT01789970|O2|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710054|NCT01789970|O1|Outcome|Hydrocodone ER (Safety Analysis Set)|All enrolled participants who were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours. Includes days on hydrocodone ER during both the titration and treatment periods.
710055|NCT01789970|O4|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710075|NCT01789814|P2|Participant Flow|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
710056|NCT01789970|O3|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710057|NCT01789970|O2|Outcome|Opioid-Experienced (Open-Label Titration Period)|"Opioid-experienced participants were defined as those who were taking 10 mg or more per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.~For opioid-experienced participants, the starting dose of hydrocodone ER tablets was to be approximately equivalent to 50% of the dose of opioid analgesic that they were receiving at screening and administered every 12 hours.~All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
710058|NCT01789970|O1|Outcome|Opioid-Naive (Open-Label Titration Period)|"Opioid-naïve participants were defined as those who were taking tramadol or less than 10 mg per day of oxycodone, or equivalent (including around-the-clock and rescue medication) for the 14 days before screening.~Opioid-naïve participants started at a 15-mg dose of hydrocodone ER tablets every 12 hours.~All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain."
710059|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710060|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710061|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710062|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710063|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710064|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710220|NCT01788163|O1|Outcome|China-Mutation Status Positive|Subjects in China that meet I/E and population criteria, who had a Positive Mutation Status.
710221|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710065|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710066|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710067|NCT01789970|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710068|NCT01789970|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710069|NCT01789970|E3|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
710070|NCT01789970|E2|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
710071|NCT01789970|E1|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
710072|NCT01789814|B3|Baseline|Total|Total of all reporting groups
710073|NCT01789814|B2|Baseline|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
710074|NCT01789814|B1|Baseline|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
710189|NCT01788163|B5|Baseline|Thailand|Subjects in Thailand that meet I/E and population criteria
710190|NCT01788163|B4|Baseline|Australia|Subjects in Australia that meet I/E and population criteria
710076|NCT01789814|P1|Participant Flow|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
710077|NCT01789814|O2|Outcome|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
710078|NCT01789814|O1|Outcome|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
710079|NCT01789814|E2|Reported Event|Clopidogrel|"Clopidogrel oral loading dose of 600 mg administered preceding cardiac intervention~Clopidogrel: Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter"
710080|NCT01789814|E1|Reported Event|Prasugrel|"Prasugrel oral loading dose of 60 mg administered preceding cardiac intervention~Prasugrel: Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy."
710081|NCT01789775|B3|Baseline|Total|Total of all reporting groups
710082|NCT01789775|B2|Baseline|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
710083|NCT01789775|B1|Baseline|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
710084|NCT01789775|P2|Participant Flow|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
710085|NCT01789775|P1|Participant Flow|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
710086|NCT01789775|O2|Outcome|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
710087|NCT01789775|O1|Outcome|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
710088|NCT01789775|E2|Reported Event|CD07805/47 Gel|"Intervention: Drug: CD07805/47 gel~CD07805/47 gel Placebo"
710089|NCT01789775|E1|Reported Event|CD07805/47 Gel Placebo|"Placebo~Drug: CD07805/47 gel"
710090|NCT01789476|B3|Baseline|Total|Total of all reporting groups
710091|NCT01789476|B2|Baseline|Placebo|Matched placebo
710092|NCT01789476|B1|Baseline|CR845|CR845 (0.005 mg/kg) IV
710093|NCT01789476|P2|Participant Flow|Placebo|Matched placebo
710094|NCT01789476|P1|Participant Flow|CR845|CR845 (0.005 mg/kg) IV
710095|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
710096|NCT01789476|O1|Outcome|Placebo|Matched placebo
710097|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
710098|NCT01789476|O1|Outcome|Placebo|Matched placebo
710099|NCT01789476|O2|Outcome|CR845|CR845 (0.005 mg/kg) IV
710100|NCT01789476|O1|Outcome|Placebo|Matched placebo
710101|NCT01789476|E2|Reported Event|Placebo|Matched placebo
710102|NCT01789476|E1|Reported Event|CR845|CR845 (0.005 mg/kg) IV
710103|NCT01789255|B1|Baseline|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
710104|NCT01789255|P1|Participant Flow|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
710105|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
710106|NCT01789255|O1|Outcome|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
710107|NCT01789255|E1|Reported Event|Supportive Care (Vorinostat, Tacrolimus, Methotrexate)|Patients receive vorinostat PO BID on days -10 to 100. Beginning on day -3, patients receive tacrolimus IV continuously or PO BID (or cyclosporine IV continuously or PO in patients unable to tolerate tacrolimus) with taper on days 100-180. Patients also receive methotrexate IV QD on days 1, 3, 6, and 11.
710108|NCT01789138|B3|Baseline|Total|Total of all reporting groups
710109|NCT01789138|B2|Baseline|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
710110|NCT01789138|B1|Baseline|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
710111|NCT01789138|P2|Participant Flow|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
710126|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710112|NCT01789138|P1|Participant Flow|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
710113|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
710114|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
710115|NCT01789138|O2|Outcome|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
710116|NCT01789138|O1|Outcome|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
710117|NCT01789138|E2|Reported Event|Adherence Counseling, Standard of Care|Standard of care: Antiretroviral therapy adherence is discussed with patient (study participant) according to usual practice in the medical institution no special protocol followed.
710149|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710118|NCT01789138|E1|Reported Event|Situated Optimal Adherence Intervention|"Situated Optimal Adherence Intervention: see 'Interventions' for more details.~Situated Optimal Adherence Intervention: Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts."
710119|NCT01788566|B1|Baseline|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710120|NCT01788566|P1|Participant Flow|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710121|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710122|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710123|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710124|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710125|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710191|NCT01788163|B3|Baseline|South Korea|Subjects in South Korea that meet I/E and population criteria
710127|NCT01788566|O1|Outcome|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710128|NCT01788566|E1|Reported Event|Gemcitabine + Cisplatin + Necitumumab|"Necitumumab administered intravenously (IV) 800 milligram (mg) on Days 1 and 8 of each 3-week cycle.~Gemcitabine administered IV at 1250 milligram per square meter (mg/m^2) on Days 1 and 8 of each 3 week cycle for a maximum of 6 cycles.~Cisplatin administered IV at 75 mg/m^2 on Day 1 of each 3 week cycle for a maximum of 6 cycles."
710129|NCT01788358|B1|Baseline|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710130|NCT01788358|P1|Participant Flow|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710131|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710132|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710150|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710133|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710134|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710135|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710136|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710137|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710138|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710139|NCT01788358|O1|Outcome|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710140|NCT01788358|E1|Reported Event|Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)|Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
710141|NCT01788228|B3|Baseline|Total|Total of all reporting groups
710142|NCT01788228|B2|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710143|NCT01788228|B1|Baseline|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710144|NCT01788228|P2|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710145|NCT01788228|P1|Participant Flow|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710146|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710147|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710148|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710222|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710151|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710152|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710153|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710154|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710155|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710156|NCT01788228|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects ≥18 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710157|NCT01788228|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine > 64 Years Group|Subjects >64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710158|NCT01788228|O1|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710159|NCT01788228|E2|Reported Event|Influenza A (H5N1)Virus Monovalent Vaccine ˃64 Years Group|Subjects ˃64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710160|NCT01788228|E1|Reported Event|Influenza A (H5N1) Virus Monovalent Vaccine 18-64 Years Group|Subjects 18-64 years of age received 2 doses of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia) at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm at Day 0 and dominant arm at Day 21.
710161|NCT01788215|B3|Baseline|Total|Total of all reporting groups
710163|NCT01788215|B1|Baseline|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710164|NCT01788215|P2|Participant Flow|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710165|NCT01788215|P1|Participant Flow|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710166|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710167|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710168|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710169|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710170|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710171|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710172|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710173|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710174|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710175|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710176|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710177|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710178|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710179|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710180|NCT01788215|O2|Outcome|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710181|NCT01788215|O1|Outcome|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710182|NCT01788215|E2|Reported Event|Sugar Pill|"The administered placebo is to be continued for a period of 12 weeks. A 12-week period thereafter will occur off placebo control~Sugar Pill: 1 pill twice a day"
710183|NCT01788215|E1|Reported Event|Doxycycline|"Subjects randomized to receive doxycycline for a period of 12 weeks. A 12-week period thereafter will occur off study medication. The dose of doxycycline to be used in this study is 200mg/day in divided doses of 100mg twice daily. The dose of doxycycline being used in this study is 100mg because it is the standard approved dose.~doxycycline: 200mg/day in divided doses of 100mg twice daily"
710184|NCT01788163|B10|Baseline|Total|Total of all reporting groups
710185|NCT01788163|B9|Baseline|Russia|Subjects in Russia that meet I/E and population criteria
710186|NCT01788163|B8|Baseline|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710187|NCT01788163|B7|Baseline|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710188|NCT01788163|B6|Baseline|Singapore|Subjects in Singapore that meet I/E and population criteria
710195|NCT01788163|P8|Participant Flow|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710196|NCT01788163|P7|Participant Flow|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710197|NCT01788163|P6|Participant Flow|Singapore|Subjects in Singapore that meet I/E and population criteria
710198|NCT01788163|P5|Participant Flow|Thailand|Subjects in Thailand that meet I/E and population criteria
710199|NCT01788163|P4|Participant Flow|Australia|Subjects in Australia that meet I/E and population criteria
710200|NCT01788163|P3|Participant Flow|South Korea|Subjects in South Korea that meet I/E and population criteria
710201|NCT01788163|P2|Participant Flow|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710202|NCT01788163|P1|Participant Flow|China|Subjects in China that meet Inclusion/Exclusion (I/E) and population criteria.
710203|NCT01788163|O18|Outcome|Russia-Mutation Status Negative|Subjects in Russia that meet I/E and population criteria, who had a Negative Mutation Status.
710204|NCT01788163|O17|Outcome|Russia-Mutation Status Positive|Subjects in Russia that meet I/E and population criteria, who had a Positive Mutation Status.
710205|NCT01788163|O16|Outcome|Indonesia-Mutation Status Negative|Subjects in Indonesia that meet I/E and population criteria, who had a Negative Mutation Status.
710206|NCT01788163|O15|Outcome|Indonesia-Mutation Status Positive|Subjects in Indonesia that meet I/E and population criteria, who had a Positive Mutation Status.
710207|NCT01788163|O14|Outcome|Malaysia-Mutation Status Negative|Subjects in Malaysia that meet I/E and population criteria, who had a Negative Mutation Status.
710208|NCT01788163|O13|Outcome|Malaysia-Mutation Status Positive|Subjects in Malaysia that meet I/E and population criteria, who had a Positive Mutation Status.
710209|NCT01788163|O12|Outcome|Singapore-Mutation Status Negative|Subjects in Singapore that meet I/E and population criteria, who had a Negative Mutation Status.
710210|NCT01788163|O11|Outcome|Singapore-Mutation Status Positive|Subjects in Singapore that meet I/E and population criteria, who had a Positive Mutation Status.
710211|NCT01788163|O10|Outcome|Thailand-Mutation Status Negative|Subjects in Thailand that meet I/E and population criteria, who had a Negative Mutation Status.
710212|NCT01788163|O9|Outcome|Thailand-Mutation Status Positive|Subjects in Thailand that meet I/E and population criteria, who had a Positive Mutation Status.
710213|NCT01788163|O8|Outcome|Australia-Mutation Status Negative|Subjects in Australia that meet I/E and population criteria, who had a Negative Mutation Status.
710214|NCT01788163|O7|Outcome|Australia-Mutation Status Positive|Subjects in Australia that meet I/E and population criteria, who had a Positive Mutation Status.
710215|NCT01788163|O6|Outcome|South Korea-Mutation Status Negative|Subjects in South Korea that meet I/E and population criteria, who had a Negative Mutation Status.
710216|NCT01788163|O5|Outcome|South Korea-Mutation Status Positive|Subjects in South Korea that meet I/E and population criteria, who had a Positive Mutation Status.
710217|NCT01788163|O4|Outcome|Taiwan-Mutation Status Negative|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Mutation Status.
710218|NCT01788163|O3|Outcome|Taiwan-Mutation Status Positive|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Mutation Status.
710233|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
710234|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
710235|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
710236|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
710237|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
710238|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
710239|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
710240|NCT01788163|O2|Outcome|EGFR Mutation Negative|Participants who were EGFR Mutation Negative for the analysis population.
710241|NCT01788163|O1|Outcome|EGFR Mutation Positive|Participants who were EGFR Mutation Positive for the analysis population.
710242|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710243|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710244|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710245|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria
710246|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710248|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710249|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710250|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710251|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710252|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710253|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710254|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710255|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710256|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710257|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
710258|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
710259|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
710260|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710261|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710262|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710263|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710264|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710265|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710266|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
710267|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
710268|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
710269|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710270|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710271|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710272|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710273|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710274|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710275|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
710276|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
710277|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
710278|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710279|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710280|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710281|NCT01788163|O8|Outcome|Russia - Negative Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Negative Predictive test performed.
710282|NCT01788163|O7|Outcome|Russia - Positive Predictive Value|Subjects in Russia that meet I/E and population criteria, who had a Positive Predictive test performed.
710283|NCT01788163|O6|Outcome|South Korea - Negative Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Negative Predictive test performed.
710284|NCT01788163|O5|Outcome|South Korea - Positive Predictive Value|Subjects in South Korea that meet I/E and population criteria, who had a Positive Predictive test performed.
710285|NCT01788163|O4|Outcome|Taiwan - Negative Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Negative Predictive test performed.
710286|NCT01788163|O3|Outcome|Taiwan - Positive Predictive Value|Subjects in Taiwan that meet I/E and population criteria, who had a Positive Predictive test performed.
710287|NCT01788163|O2|Outcome|China - Negative Predictive Value|Subjects in China that meet I/E and population criteria, who had a Negative Predictive test performed.
710288|NCT01788163|O1|Outcome|China - Positive Predictive Value|Subjects in China that meet I/E and population criteria, who had a Positive Predictive test performed.
710289|NCT01788163|O8|Outcome|Russia - Specificity|Subjects in Russia that meet I/E and population criteria, who had a specificity test performed.
710290|NCT01788163|O7|Outcome|Russia - Sensitivity|Subjects in Russia that meet I/E and population criteria, who had a sensitivity test performed.
710291|NCT01788163|O6|Outcome|South Korea - Specificity|Subjects in South Korea that meet I/E and population criteria, who had a specificity test performed.
710292|NCT01788163|O5|Outcome|South Korea - Sensitivity|Subjects in South Korea that meet I/E and population criteria, who had a sensitivity test performed.
710293|NCT01788163|O4|Outcome|Taiwan - Specificity|Subjects in Taiwan that meet I/E and population criteria, who had a specificity test performed.
710294|NCT01788163|O3|Outcome|Taiwan - Sensitivity|Subjects in Taiwan that meet I/E and population criteria, who had a sensitivity test performed.
710295|NCT01788163|O2|Outcome|China - Specificty|Subjects in China that meet I/E and population criteria, who had a specificity test performed.
710296|NCT01788163|O1|Outcome|China - Sensitivity|Subjects in China that meet I/E and population criteria, who had a sensitivity test performed.
710297|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710298|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710299|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710300|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710301|NCT01788163|O8|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710302|NCT01788163|O7|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
710303|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710304|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
710305|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710306|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
710307|NCT01788163|O2|Outcome|China-Non-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710308|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
710309|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710310|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710311|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710312|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710313|NCT01788163|O4|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710314|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710315|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710316|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710317|NCT01788163|O18|Outcome|Russia-Non-adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710318|NCT01788163|O17|Outcome|Russia-Adenocarcinoma|Subjects in Russia that meet I/E and population criteria with a histological type of Adenocarcinoma.
710319|NCT01788163|O16|Outcome|Indonesia-Non-adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710320|NCT01788163|O15|Outcome|Indonesia-Adenocarcinoma|Subjects in Indonesia that meet I/E and population criteria with a histological type of Adenocarcinoma.
710321|NCT01788163|O14|Outcome|Malaysia-Non-adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710322|NCT01788163|O13|Outcome|Malaysia-Adenocarcinoma|Subjects in Malaysia that meet I/E and population criteria with a histological type of Adenocarcinoma.
710323|NCT01788163|O12|Outcome|Singapore-Non-adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710324|NCT01788163|O11|Outcome|Singapore-Adenocarcinoma|Subjects in Singapore that meet I/E and population criteria with a histological type of Adenocarcinoma.
710325|NCT01788163|O10|Outcome|Thailand-Non-adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710326|NCT01788163|O9|Outcome|Thailand-Adenocarcinoma|Subjects in Thailand that meet I/E and population criteria with a histological type of Adenocarcinoma.
710327|NCT01788163|O8|Outcome|Australia-Non-adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710328|NCT01788163|O7|Outcome|Australia-Adenocarcinoma|Subjects in Australia that meet I/E and population criteria with a histological type of Adenocarcinoma.
710329|NCT01788163|O6|Outcome|South Korea-Non-adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710330|NCT01788163|O5|Outcome|South Korea-Adenocarcinoma|Subjects in South Korea that meet I/E and population criteria with a histological type of Adenocarcinoma.
710331|NCT01788163|O4|Outcome|Taiwan-Non-adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710332|NCT01788163|O3|Outcome|Taiwan-Adenocarcinoma|Subjects in Taiwan that meet I/E and population criteria with a histological type of Adenocarcinoma.
710333|NCT01788163|O2|Outcome|China-Non-adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Non-Adenocarcinoma.
710334|NCT01788163|O1|Outcome|China-Adenocarcinoma|Subjects in China that meet I/E and population criteria with a histological type of Adenocarcinoma.
710335|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710336|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710337|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710338|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
710339|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
710342|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710343|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710344|NCT01788163|O9|Outcome|Russia|Subjects in Russia that meet I/E and population criteria
710345|NCT01788163|O8|Outcome|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710346|NCT01788163|O7|Outcome|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710347|NCT01788163|O6|Outcome|Singapore|Subjects in Singapore that meet I/E and population criteria
710348|NCT01788163|O5|Outcome|Thailand|Subjects in Thailand that meet I/E and population criteria
710349|NCT01788163|O4|Outcome|Australia|Subjects in Australia that meet I/E and population criteria
710350|NCT01788163|O3|Outcome|South Korea|Subjects in South Korea that meet I/E and population criteria
710351|NCT01788163|O2|Outcome|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710352|NCT01788163|O1|Outcome|China|Subjects in China that meet I/E and population criteria.
710353|NCT01788163|E9|Reported Event|Russia|Subjects in Russia that meet I/E and population criteria
710354|NCT01788163|E8|Reported Event|Indonesia|Subjects in Indonesia that meet I/E and population criteria
710355|NCT01788163|E7|Reported Event|Malaysia|Subjects in Malaysia that meet I/E and population criteria
710356|NCT01788163|E6|Reported Event|Singapore|Subjects in Singapore that meet I/E and population criteria
710357|NCT01788163|E5|Reported Event|Thailand|Subjects in Thailand that meet I/E and population criteria
710358|NCT01788163|E4|Reported Event|Australia|Subjects in Australia that meet I/E and population criteria
710359|NCT01788163|E3|Reported Event|South Korea|Subjects in South Korea that meet I/E and population criteria
710360|NCT01788163|E2|Reported Event|Taiwan|Subjects in Taiwan that meet I/E and population criteria
710361|NCT01788163|E1|Reported Event|China|Subjects in China that meet I/E and population criteria.
710362|NCT01788046|B3|Baseline|Total|Total of all reporting groups
710363|NCT01788046|B2|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710364|NCT01788046|B1|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710365|NCT01788046|P2|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710366|NCT01788046|P1|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710367|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710368|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710369|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710370|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710371|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710372|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710373|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710374|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710375|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710376|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710377|NCT01788046|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710378|NCT01788046|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710379|NCT01788046|E2|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session TIW for 26 weeks.
710380|NCT01788046|E1|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710381|NCT01787838|B1|Baseline|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
710382|NCT01787838|P1|Participant Flow|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
710383|NCT01787838|O1|Outcome|Health Education, Audit and Feedback|"Prospective single group intervention Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about immunizations."
710384|NCT01787838|E1|Reported Event|Health Education, Audit and Feedback|"Prospective single group intervention with retrospective control group with no intervention.~Focused Health Education: A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
710385|NCT01787825|B1|Baseline|All Study Participants|"PillCam SB2 capsule and CapsoCam SV-1 capsule in random order, PillCam SB2 capsule: Capsule Endoscopy system, CapsoCam SV-1: Capsule endoscopy~The analysis population consisted of subjects that swallowed the capsules."
710386|NCT01787825|P2|Participant Flow|PillCam SB2 Then CapsoCam SV-1|Participants first received PillCam SB2 then 30-60 minutes later receive CapsoCam SV-1
710387|NCT01787825|P1|Participant Flow|CapsoCam SV-1 Then PillCam SB2|Participants first received CapsoCam SV-1 then 30-60 minutes later received Pillcam SB2
710388|NCT01787825|O2|Outcome|PillCam SB2|Subject preference for PillCam SB2
710389|NCT01787825|O1|Outcome|CapsoCam SV-1 Preference|Subject preference for CapsoCam SV-1
710390|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
710391|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
710392|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
710393|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
710394|NCT01787825|O2|Outcome|PillCam SB2|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
710395|NCT01787825|O1|Outcome|CapsoCam SV-1|Each participation swallowed both PillCam SB2 and CapsoCam SV-1 30-60 minutes apart. The order in which the cams were swallowed was randomized.
710396|NCT01787825|E1|Reported Event|All Study Participants|PillCam SB Capsule and CapsoCam SV-1
710397|NCT01787799|B1|Baseline|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
710398|NCT01787799|P1|Participant Flow|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
710399|NCT01787799|O1|Outcome|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
710400|NCT01787799|E1|Reported Event|SYNERGY Stent System|"SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System)~SYNERGY: Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating."
710401|NCT01787760|B4|Baseline|Total|Total of all reporting groups
710402|NCT01787760|B3|Baseline|Spectacle Lenses|Control spectacle lenses worn daily.
710403|NCT01787760|B2|Baseline|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
710404|NCT01787760|B1|Baseline|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
710405|NCT01787760|P3|Participant Flow|Spectacle Lenses|Control spectacle lenses worn daily.
710406|NCT01787760|P2|Participant Flow|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality
710407|NCT01787760|P1|Participant Flow|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality
710408|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
710409|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
710410|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
710411|NCT01787760|O3|Outcome|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
710412|NCT01787760|O2|Outcome|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
710413|NCT01787760|O1|Outcome|Spectacle Lenses|Control spectacle lenses worn daily.
710414|NCT01787760|E4|Reported Event|Not Randomized|Subjects who met the all study eligible criteria but did not randomize to the study arm.
710415|NCT01787760|E3|Reported Event|Test Soft Contact Lens C|Lenses will be worn in a daily disposable modality.
710416|NCT01787760|E2|Reported Event|Test Soft Contact Lens B|Lenses will be worn in a daily disposable modality.
710417|NCT01787760|E1|Reported Event|Spectacle Lenses|Control spectacle lenses worn daily.
710418|NCT01787591|B3|Baseline|Total|Total of all reporting groups
710419|NCT01787591|B2|Baseline|Metabolic Syndrome Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
710550|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710420|NCT01787591|B1|Baseline|Healthy Participants|As a randomized crossover study design, participants were stratified by health status (healthy versus metabolic syndrome) and received fat-free milk, low-fat milk, full-fat milk, and soy milk in a randomized order.
710421|NCT01787591|P4|Participant Flow|Acute Soy Milk Ingestion First|"Participants ingested soy milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and fat-free milk.~Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710422|NCT01787591|P3|Participant Flow|Acute Full-Fat Milk Ingestion First|"Participants ingested full-free milk first and then the remaining three milks in a randomized order: low-fat milk, low-fat milk, and soy milk.~Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710423|NCT01787591|P2|Participant Flow|Acute Low-Fat Milk Ingestion First|"Participants ingested low-free milk first and then the remaining three milks in a randomized order: fat-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710574|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710575|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710424|NCT01787591|P1|Participant Flow|Acute Fat-Free Milk Ingestion First|"Participants ingested fat-free milk first and then the remaining three milks in a randomized order: low-fat milk, full-fat milk, and soy milk.~Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710425|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
710426|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710427|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710428|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710429|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
710430|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710431|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710432|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710433|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
710434|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710435|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710436|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710437|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants ingested 1 cup of soy milk with deuterium labeled alpha-tocopherol
710438|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710439|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710440|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710441|NCT01787591|O4|Outcome|Acute Soy Milk Ingestion|Participants received 1 cup of soy milk with deuterium labeled alpha-tocopherol
710442|NCT01787591|O3|Outcome|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710443|NCT01787591|O2|Outcome|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710444|NCT01787591|O1|Outcome|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710445|NCT01787591|E4|Reported Event|Acute Soy Milk Ingestion|"Participants will ingest 1 cup of soy milk with 15 mg deuterium-labeled alpha-tocopherol.~Soy Milk: Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710446|NCT01787591|E3|Reported Event|Acute Full-Fat Milk Ingestion|"Participants will ingest 1 cup of full-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Full-Fat Milk: Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710447|NCT01787591|E2|Reported Event|Acute Low-Fat Milk Ingestion|"Participants will ingest 1 cup of low-fat milk with 15 mg deuterium-labeled alpha-tocopherol.~Low-Fat Milk: Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710551|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710552|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710448|NCT01787591|E1|Reported Event|Acute Fat-Free Milk Ingestion|"Participants will ingest 1 cup of fat-free milk with 15 mg deuterium-labeled alpha-tocopherol.~Fat-Free Milk: Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol."
710449|NCT01787461|B3|Baseline|Total|Total of all reporting groups
710450|NCT01787461|B2|Baseline|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710451|NCT01787461|B1|Baseline|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710452|NCT01787461|P2|Participant Flow|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710453|NCT01787461|P1|Participant Flow|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710454|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710455|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710456|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710457|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710458|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710459|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710460|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710461|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710462|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710463|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710464|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710465|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710466|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710467|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710468|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710469|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710470|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710471|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710472|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710473|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710474|NCT01787461|O2|Outcome|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710475|NCT01787461|O1|Outcome|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710476|NCT01787461|E2|Reported Event|Imedeen|Imedeen (two tablets) containing marine complex at 210 (milligrams) mg, vitamin C at 48 mg, zinc at 3.6 g and tomato fruit and grape extract blend at 56 mg, orally daily for 24 weeks.
710477|NCT01787461|E1|Reported Event|Placebo|Two Placebo tablets matched to Imedeen, orally daily for 24 weeks.
710478|NCT01787383|B3|Baseline|Total|Total of all reporting groups
710479|NCT01787383|B2|Baseline|Ingenol Mebutate Gel Sequential Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied sequentially~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied sequentially"
710480|NCT01787383|B1|Baseline|Ingenol Mebutate Gel Simultaneous Treatment|"Ingenol mebutate gel 0.05 %: Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities applied simultaneously~Ingenol mebutate gel 0.015 %: Ingenol mebutate gel 0.015 % (Picato®) on face/scalp applied simultaneously"
710481|NCT01787383|P2|Participant Flow|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710482|NCT01787383|P1|Participant Flow|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710483|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
710553|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710554|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710555|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710484|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Convenience TSQM compliance was lower than the number of randomised subjects.
710485|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
710486|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Global Satisfaction TSQM compliance was lower than the number of randomised subjects.
710487|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side Effects TSQM compliance was lower than the number of randomised subjects.
710576|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710577|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710578|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710488|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Side EffectsTSQM compliance was lower than the number of randomised subjects.
710489|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
710490|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities. The Effectiveness TSQM compliance was lower than the number of randomised subjects.
710491|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710492|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710493|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710494|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710495|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710496|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710497|NCT01787383|O2|Outcome|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710498|NCT01787383|O1|Outcome|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015 %: and 0.05 %) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710499|NCT01787383|E2|Reported Event|Ingenol Mebutate Gel Sequential Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied sequentially: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710500|NCT01787383|E1|Reported Event|Ingenol Mebutate Gel Simultaneous Treatment|Ingenol mebutate gel in 2 doses (0.015% and 0.05%) were applied simultaneously: ingenol mebutate gel 0.015% (Picato®) was applied once daily for 3 consecutive days on on face/scalp and ingenol mebutate gel 0.05% (Picato®) was applied once daily for 2 consecutive days on trunk/extremities.
710501|NCT01787279|B1|Baseline|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710556|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710502|NCT01787279|P1|Participant Flow|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered peg interferon alpha-2a (PEGASYS), 40 kilodalton (kD), 180 micrograms (mcg), subcutaneously, once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710503|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710504|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710505|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710506|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710507|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710508|NCT01787279|O1|Outcome|Peginterferon Alpha-2a, 180 mcg/48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710509|NCT01787279|E1|Reported Event|Peginterferon Alpha-2a, 180 mcg/ 48 Weeks|Eligible participants with HI3vAg (a type of hepatitis B surface antigen) negative chronic hepatitis B administered PEGASYS, 40kD, 180 mcg, subcutaneously once weekly for 48 weeks. The untreated follow-up was for 24 weeks.
710510|NCT01787240|B3|Baseline|Total|Total of all reporting groups
710511|NCT01787240|B2|Baseline|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
710512|NCT01787240|B1|Baseline|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
710513|NCT01787240|P2|Participant Flow|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
710514|NCT01787240|P1|Participant Flow|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
710515|NCT01787240|O2|Outcome|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
710516|NCT01787240|O1|Outcome|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
710517|NCT01787240|O2|Outcome|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
710518|NCT01787240|O1|Outcome|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
710519|NCT01787240|O2|Outcome|Phase 2 Active|Participants assigned to take active drug who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
710520|NCT01787240|O1|Outcome|Phase 2 Placebo|Participants assigned to take placebo who did not respond by the end of phase 1 (Week 5 of study treatment) continued onto phase 2.
710521|NCT01787240|O1|Outcome|Eligible Patients|Number of patients who were screened and were determined to be eligible for the study.
710522|NCT01787240|E2|Reported Event|Escitalopram 10mg|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Escitalopram 10mg"
710523|NCT01787240|E1|Reported Event|Placebo|"After a screening visit, the patient will undergo a baseline assessment and will be randomized to escitalopram 10mg or placebo.~Placebo"
710524|NCT01787188|B4|Baseline|Total|Total of all reporting groups
710525|NCT01787188|B3|Baseline|Placebo|Placebo: Capsule
710526|NCT01787188|B2|Baseline|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710527|NCT01787188|B1|Baseline|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710528|NCT01787188|P3|Participant Flow|Placebo|Placebo: Capsule
710529|NCT01787188|P2|Participant Flow|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710530|NCT01787188|P1|Participant Flow|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710531|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710532|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710533|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710534|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710535|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710536|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710537|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710538|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710539|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710540|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710541|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710542|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710543|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710544|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710545|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710546|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710547|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710548|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710549|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710557|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710558|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710559|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710560|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710561|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710562|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710563|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710564|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710565|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710566|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710567|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710568|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710569|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710570|NCT01787188|O3|Outcome|Placebo|Placebo: Capsule
710571|NCT01787188|O2|Outcome|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710572|NCT01787188|O1|Outcome|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710580|NCT01787188|E2|Reported Event|Meloxicam 10 mg Once Daily|Meloxicam 10 mg: Capsules
710581|NCT01787188|E1|Reported Event|Meloxicam 5 mg Once Daily|Meloxicam 5 mg: Capsules
710582|NCT01787175|B3|Baseline|Total|Total of all reporting groups
710583|NCT01787175|B2|Baseline|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710584|NCT01787175|B1|Baseline|Integration Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710585|NCT01787175|P2|Participant Flow|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710586|NCT01787175|P1|Participant Flow|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710587|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710588|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710589|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710590|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710591|NCT01787175|O2|Outcome|Standard EHR|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710592|NCT01787175|O1|Outcome|Integrated Medication Manager|Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.
710593|NCT01787175|E2|Reported Event|Standard EHR|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
710594|NCT01787175|E1|Reported Event|Integrated Medication Manager|"Experienced providers that participated in the EHR simulations. Half of the providers were assigned to use the new Integrated Medication Manager (intervention) during the simulation. The other half were assigned the VA's CPRS to use (standard EHR). Providers were randomly assigned which system to use.~Integrated Medication Manager: A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use."
710595|NCT01787032|B7|Baseline|Total|Total of all reporting groups
710596|NCT01787032|B6|Baseline|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710597|NCT01787032|B5|Baseline|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710632|NCT01786993|P1|Participant Flow|Multi-point Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
710633|NCT01786993|O2|Outcome|Biventricular Arm|"Traditional Biventricular Pacing~Traditional Biventricular Pacing: Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available."
710895|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710598|NCT01787032|B4|Baseline|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710599|NCT01787032|B3|Baseline|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710600|NCT01787032|B2|Baseline|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710601|NCT01787032|B1|Baseline|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710602|NCT01787032|P6|Participant Flow|BI 113608 + Voriconazole/ BI 113608 + Ketoconazole/ BI 113608|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710603|NCT01787032|P5|Participant Flow|BI 113608 + Voriconazole/ BI 113608/ BI 113608 + Ketoconazole|"The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710604|NCT01787032|P4|Participant Flow|BI 113608 + Ketoconazole/ BI 113608 + Voriconazole/ BI 113608|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710624|NCT01787032|E4|Reported Event|Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
710670|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710605|NCT01787032|P3|Participant Flow|BI 113608 + Ketoconazole/ BI 113608/ BI 113608 + Voriconazole|"The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours followed by BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710606|NCT01787032|P2|Participant Flow|BI 113608/BI 113608 + Voriconazole/ BI 113608 + Ketoconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710634|NCT01786993|O1|Outcome|MultiPoint Pacing Arm|"MultiPoint Pacing~MultiPoint Pacing: Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study."
710607|NCT01787032|P1|Participant Flow|BI 113608/BI 113608 + Ketoconazole/BI 113608 + Voriconazole|"The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water followed by Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) followed by Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.~A wash-out period of at least 6 days was respected between the administrations of BI 113608."
710608|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710609|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710610|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
710611|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710612|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710613|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
710614|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710615|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710616|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
710617|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710618|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710619|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
710620|NCT01787032|O3|Outcome|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710621|NCT01787032|O2|Outcome|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710622|NCT01787032|O1|Outcome|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
710623|NCT01787032|E5|Reported Event|Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) orally with 240 mL of water after an overnight fast of at least 10 hours.
710669|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710625|NCT01787032|E3|Reported Event|BI 113608 + Voriconazole|The subjects received Voriconazole (400 mg bid) (Brand name: Vfend® 200 mg film tablets) for 1 day on Day -2 (loading dose) Voriconazole (200 mg bid) for 3 days (Days -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710626|NCT01787032|E2|Reported Event|BI 113608 + Ketoconazole|The subjects received Ketokonazol film-coated tablet (200 mg bid) (Brand name: Ketokonazol Polfarmex 200 mg film tablets) for 4 days (Days -2, -1, 1, and 2) plus BI 113608 (25 mg single dose) for 1 day (Day 1) orally with 240 mL of water after an overnight fast of at least 10 hours.
710627|NCT01787032|E1|Reported Event|BI 113608|The subjects received BI 113608 film-coated tablet 25 mg orally for 1 day (Day 1) orally with 240 mL of water.
710628|NCT01786993|B3|Baseline|Total|Total of all reporting groups
710629|NCT01786993|B2|Baseline|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
710630|NCT01786993|B1|Baseline|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
710631|NCT01786993|P2|Participant Flow|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
710811|NCT01786330|P2|Participant Flow|Control|"Group receives standard of care~Standard of Care"
710635|NCT01786993|O1|Outcome|BiV/MPP Patients|Of 469 subjects who underwent an attempted implant, 31 subjects experienced a system-related complication between implant and 9 months (13 were LV lead-related, 16 were RA/RV lead-related and 3 were Quadripolar CRT-D pulse generator related. One subject experienced more than one category of complication).
710636|NCT01786993|E2|Reported Event|Biventricular Arm|Subjects were programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
710637|NCT01786993|E1|Reported Event|MultiPoint Pacing Arm|Subjects were programmed to MPP between 3 and 9 months. MPP programming was stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
710638|NCT01786954|B1|Baseline|Icare, Goldmann, Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
710639|NCT01786954|P2|Participant Flow|Sequence 2: Icare Then Tonopen Then Goldmann|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Tonopen applanation then Goldmann applanation.~Icare rebound tonometry~Tonopen applanation~Goldmann applanation"
710640|NCT01786954|P1|Participant Flow|Sequence 1: Icare Then Goldmann Then Tonopen|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry then Goldmann applanation then Tonopen applanation.~Icare rebound tonometry~Goldmann applanation~Tonopen applanation"
710641|NCT01786954|O3|Outcome|Goldmann|
710642|NCT01786954|O2|Outcome|Tonopen|
710643|NCT01786954|O1|Outcome|Icare|
710644|NCT01786954|O3|Outcome|Goldmann|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
710645|NCT01786954|O2|Outcome|Tonopen|Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.
710646|NCT01786954|O1|Outcome|Icare|"Enrolled patients will be subjected to intraocular pressure measurement using Icare rebound tonometry, Tonopen applanation, and Goldmann applanation.~Icare rebound tonometry"
710647|NCT01786954|E2|Reported Event|Sequence 2: Icare, Tonopen, Goldmann|Sequence 2: Icare, then Tonopen, then Goldmann
710648|NCT01786954|E1|Reported Event|Sequence 1: Icare, Goldmann, Tonopen|Sequence 1: Icare, then Goldmann, then Tonopen
710649|NCT01786902|B3|Baseline|Total|Total of all reporting groups
710650|NCT01786902|B2|Baseline|Non-treatment Control Group|Height be measured with no treatment
710651|NCT01786902|B1|Baseline|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
710652|NCT01786902|P2|Participant Flow|Non-treatment Control Group|Height be measured with no treatment
710653|NCT01786902|P1|Participant Flow|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
710654|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
710655|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
710656|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
710657|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
710658|NCT01786902|O2|Outcome|Non-treatment Control Group|Height be measured with no treatment
710659|NCT01786902|O1|Outcome|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
710660|NCT01786902|E2|Reported Event|Non-treatment Control Group|Height be measured with no treatment
710661|NCT01786902|E1|Reported Event|DA-3002 Treatment Group|"1.11 IU(0.37mg)/kg bodyweight of DA-3002 per week given by subcutaneous injections (six or seven times per week)~DA-3002"
710662|NCT01786876|B1|Baseline|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710663|NCT01786876|P1|Participant Flow|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710664|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710665|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710666|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710667|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710668|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710671|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710672|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710673|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710674|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710675|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710676|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710677|NCT01786876|O1|Outcome|Radiolabeled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710678|NCT01786876|E1|Reported Event|Radiolabelled SSP-002358|A single oral dose of 2 mg radiolabeled SSP-002358 administered on Day 1
710679|NCT01786707|B3|Baseline|Total|Total of all reporting groups
710680|NCT01786707|B2|Baseline|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
710681|NCT01786707|B1|Baseline|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
710682|NCT01786707|P2|Participant Flow|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
710683|NCT01786707|P1|Participant Flow|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
710684|NCT01786707|O2|Outcome|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
710685|NCT01786707|O1|Outcome|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
710686|NCT01786707|E2|Reported Event|Control Group|Patients in a control group will continue with standard medical treatment (SMT)
710687|NCT01786707|E1|Reported Event|Autologous SC and HOT|"Autologous stem cells and hyperbaric oxygen therapy~Autologous stem cells and hyperbaric oxygen therapy: Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months. Then they will be randomized to either control or intervention groups. HOT and SC group: combination of HOT therapy and intrapancreatic autologous SC infusion in addition to SMT."
710688|NCT01786668|B5|Baseline|Total|Total of all reporting groups
710689|NCT01786668|B4|Baseline|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710690|NCT01786668|B3|Baseline|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710691|NCT01786668|B2|Baseline|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710692|NCT01786668|B1|Baseline|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710693|NCT01786668|P4|Participant Flow|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710694|NCT01786668|P3|Participant Flow|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710695|NCT01786668|P2|Participant Flow|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710696|NCT01786668|P1|Participant Flow|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the morning [AM] and afternoon [PM]) for a total of 12 weeks.
710697|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710698|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710699|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710700|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710701|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710702|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710703|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710704|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710705|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710706|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710707|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710708|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710709|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710710|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710711|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710712|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710713|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710714|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710715|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710716|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710717|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710718|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710719|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710720|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710721|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710722|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710723|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710724|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710725|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710726|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710727|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710728|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710729|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710730|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710731|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710732|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710733|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710734|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710735|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710799|NCT01786629|O1|Outcome|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
710736|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710737|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710738|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710739|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710740|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710741|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710848|NCT01786174|B2|Baseline|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710742|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710743|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710744|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710745|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710746|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710747|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710748|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710749|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710750|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710751|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710752|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710753|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710754|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710755|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710756|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710757|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710758|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710759|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710760|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710761|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710762|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710763|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710764|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710765|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710766|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710767|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710768|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710769|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710770|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710771|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710772|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710896|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710773|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710774|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710775|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710776|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710777|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710778|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710779|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710780|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710781|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710782|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710783|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710784|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710785|NCT01786668|O4|Outcome|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710786|NCT01786668|O3|Outcome|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710787|NCT01786668|O2|Outcome|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710788|NCT01786668|O1|Outcome|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710789|NCT01786668|E4|Reported Event|Placebo BID|Participants were administered 4 tablets (two 1 mg placebo tablets and two 5 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710790|NCT01786668|E3|Reported Event|Tofacitinib 10 mg BID|Participants were administered 4 tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) orally twice a day (in the AM and PM) for a total of 12 weeks.
710791|NCT01786668|E2|Reported Event|Tofacitinib 5 mg BID|Participants were administered 4 tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710792|NCT01786668|E1|Reported Event|Tofacitinib 2 mg BID|Participants were administered 4 tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) orally BID (in the AM and PM) for a total of 12 weeks.
710793|NCT01786629|B3|Baseline|Total|Total of all reporting groups
710794|NCT01786629|B2|Baseline|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
710795|NCT01786629|B1|Baseline|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
710796|NCT01786629|P2|Participant Flow|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
710797|NCT01786629|P1|Participant Flow|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
710798|NCT01786629|O2|Outcome|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
710877|NCT01786109|B4|Baseline|Total|Total of all reporting groups
710800|NCT01786629|E2|Reported Event|FDA Approved Bowel Preparation|"FDA approved bowel preparation containing electrolytes~FDA approved bowel preparation containing electrolytes: solution for oral administration prior to colonoscopy"
710801|NCT01786629|E1|Reported Event|SUPREP Bowel Prep Kit|"SUPREP Bowel Prep Kit~SUPREP Bowel Prep Kit: solution for oral administration prior to colonoscopy"
710802|NCT01786551|B1|Baseline|Eplerenone|Eplerenone 50 mg daily for 14 days
710803|NCT01786551|P1|Participant Flow|Eplerenone|Eplerenone 50 mg daily for 14 days
710804|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
710805|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
710806|NCT01786551|O1|Outcome|Eplerenone|Eplerenone 50 mg daily for 14 days
710807|NCT01786551|E1|Reported Event|Eplerenone|Eplerenone 50 mg daily for 14 days
710808|NCT01786330|B3|Baseline|Total|Total of all reporting groups
710809|NCT01786330|B2|Baseline|Control|"Group receives standard of care~Standard of Care"
710810|NCT01786330|B1|Baseline|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
710812|NCT01786330|P1|Participant Flow|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
710813|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
710814|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
710815|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
710816|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
710817|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
710818|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
710819|NCT01786330|O2|Outcome|Control|"Group receives standard of care~Standard of Care"
710820|NCT01786330|O1|Outcome|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
710821|NCT01786330|E2|Reported Event|Control|"Group receives standard of care~Standard of Care"
710822|NCT01786330|E1|Reported Event|Intervention|"Group receives elastic abdominal binders after surgery. Binder used is Procare manufactured by DJO, LLC. Binders are to be worn for 24 hours after surgery.~Procare abdominal binder"
710823|NCT01786252|B3|Baseline|Total|Total of all reporting groups
710824|NCT01786252|B2|Baseline|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
710825|NCT01786252|B1|Baseline|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
710826|NCT01786252|P2|Participant Flow|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
710827|NCT01786252|P1|Participant Flow|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
710828|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
710829|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
710878|NCT01786109|B3|Baseline|Placebo|One dose of placebo will be taken orally with water.
710879|NCT01786109|B2|Baseline|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710880|NCT01786109|B1|Baseline|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710830|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
710831|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
710832|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
710849|NCT01786174|B1|Baseline|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710833|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
710834|NCT01786252|O2|Outcome|"IVF Media (Global-Trademark)"|"Placebo Comparator for hCG. A single intrauterine infusion of IVF media without hCG will be administered to participants in the control group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic and a sample of uterine secretory proteins and endometrial tissue, will be obtained via uterine lavage and endometrial biopsy, respectively, for research analysis.~Placebo Comparator (for hCG): 50ul of IVF medium (Global-trademark) to mimic hCG infusion"
710835|NCT01786252|O1|Outcome|Drug: Human Chorionic Gonadotropin (hCG)|"Drug: human chorionic gonadotropin (hCG). A single intrauterine infusion of 500IU hCG dissolved in IVF media (Global-trademark) will be administered to participants in the experimental group three days after oocyte retrieval. Two days after this infusion, participant will return to clinic where a uterine lavage and an endometrial biopsy will be performed to obtain a sample of uterine secretory proteins and endometrial tissue, respectively, for research analysis.~human chorionic gonadotropin (hCG): 500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
710836|NCT01786252|E2|Reported Event|Drug: Human Chorionic Gonadotropin (hCG)|Received hCG infusion on Day 3 Post-Ovulation Induction
710837|NCT01786252|E1|Reported Event|"IVF Media (Global-Trademark)"|Received IVF media infusion on Day 3 Post-Ovulation Induction
710838|NCT01786239|B3|Baseline|Total|Total of all reporting groups
710839|NCT01786239|B2|Baseline|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
710840|NCT01786239|B1|Baseline|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
710841|NCT01786239|P2|Participant Flow|Amber50/50 Soybean Corn Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Amber 50/50 Soybean/Corn Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
710842|NCT01786239|P1|Participant Flow|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
710843|NCT01786239|O2|Outcome|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
710881|NCT01786109|P3|Participant Flow|Placebo|One dose of placebo will be taken orally with water.
710882|NCT01786109|P2|Participant Flow|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710844|NCT01786239|O1|Outcome|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
710845|NCT01786239|E2|Reported Event|Placebo & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening.The placebo is a soybean/corn blend (each capsule contains 1000 mg). The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Placebo: The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion."
710846|NCT01786239|E1|Reported Event|Omega-3 Capsules & Risperidone|"Subjects will take 1 capsule in the morning and 1 capsule in the evening. Each capsule contains 370 mg EPA and 200 mg DHA as well as 2 mg/g tocopherol. The study dose will start on day 1 and remain the same throughout the study.~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.~Omega-3 capsules: The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion."
710847|NCT01786174|B3|Baseline|Total|Total of all reporting groups
710894|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710850|NCT01786174|P2|Participant Flow|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710851|NCT01786174|P1|Participant Flow|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710852|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710853|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710854|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710855|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710856|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710857|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710858|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710859|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710860|NCT01786174|O2|Outcome|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710861|NCT01786174|O1|Outcome|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710862|NCT01786174|E2|Reported Event|Placebo|"0.5mg placebo (sugar pill) orally once daily for 28 days +/- 3 days~Placebo: 0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days"
710863|NCT01786174|E1|Reported Event|Gilenya (Fingolimod)|"0.5mg Gilenya (fingolimod) orally once daily for 28 days +/- 3 days~Gilenya: 0.5mg Gilenya orally by mouth once daily for approximately 28 days"
710864|NCT01786161|B3|Baseline|Total|Total of all reporting groups
710865|NCT01786161|B2|Baseline|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
710866|NCT01786161|B1|Baseline|Vancomycin Continous Infusion|Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion infusion rate 1000mg/hr
710867|NCT01786161|P2|Participant Flow|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
710868|NCT01786161|P1|Participant Flow|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
710869|NCT01786161|O2|Outcome|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
710870|NCT01786161|O1|Outcome|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
710871|NCT01786161|O2|Outcome|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
710872|NCT01786161|O1|Outcome|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
710873|NCT01786161|O2|Outcome|Vancomycin With Intermittent Dose Interval|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
710874|NCT01786161|O1|Outcome|Vancomycin With Continuous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
710875|NCT01786161|E2|Reported Event|Intermittent Infusion|"infusion rate 1000mg/hr~Vancomycin intermittent dosing interval: Vancomycin intravenous infusion at rate 1000mg/hr"
710876|NCT01786161|E1|Reported Event|Vancomycin Continous Infusion|"continuous 24 hours intravenous infusion~Vancomycin continuous infusion: Vancomycin 24 hour intravenous continuous infusion"
710883|NCT01786109|P1|Participant Flow|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710884|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710885|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710886|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710887|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710888|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710889|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710890|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710891|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710892|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710893|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710897|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710898|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710899|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710900|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710901|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710902|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710903|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710904|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710905|NCT01786109|O3|Outcome|Placebo|One dose of placebo will be taken orally with water.
710906|NCT01786109|O2|Outcome|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710907|NCT01786109|O1|Outcome|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710908|NCT01786109|E3|Reported Event|Placebo|One dose of placebo will be taken orally with water.
710909|NCT01786109|E2|Reported Event|Dronabinol 5 mg|One dose of dronabinol 5 mg will be taken orally with water.
710910|NCT01786109|E1|Reported Event|Dronabinol 2.5 mg|One dose of dronabinol 2.5 mg will be taken orally with water.
710911|NCT01785875|B1|Baseline|Etelcalcetide|All participants received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks during the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710912|NCT01785875|P3|Participant Flow|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710913|NCT01785875|P2|Participant Flow|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710914|NCT01785875|P1|Participant Flow|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710915|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710916|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710917|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710918|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710919|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710920|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710921|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
711015|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
712373|NCT01778855|P1|Participant Flow|Normothermia|IV t-PA and normothermia
710922|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710923|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710924|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710925|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710926|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710927|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710928|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710929|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710930|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710931|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710932|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710933|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710934|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710935|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710936|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710937|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710938|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710939|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710940|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
711016|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
710941|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710942|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710943|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710944|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
711028|NCT01785615|P2|Participant Flow|Sugar Pill|"44 women with metabolic syndrome randomized to placebo for 6 weeks~Placebo : 80mg"
710945|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710946|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710947|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710948|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710949|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710950|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710951|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710952|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710953|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710954|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710955|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710956|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710957|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710958|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710959|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710960|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710961|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710962|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710963|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
711087|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
710964|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710965|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710966|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710967|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710968|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710969|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710970|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710971|NCT01785875|O1|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710972|NCT01785875|O4|Outcome|Etelcalcetide Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710973|NCT01785875|O3|Outcome|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710974|NCT01785875|O2|Outcome|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710975|NCT01785875|O1|Outcome|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710976|NCT01785875|E4|Reported Event|Total|Participants received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710977|NCT01785875|E3|Reported Event|20120359 Etelcalcetide|Participants who received etelcalcetide in parent study 20120359 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710978|NCT01785875|E2|Reported Event|20120229 / 20120230 Etelcalcetide|Participants who received etelcalcetide in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg TIW for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710979|NCT01785875|E1|Reported Event|20120229 / 20120230 Placebo|Participants who received placebo in parent study 20120229 or 20120230 received etelcalcetide at a starting dose of 5 mg three times a week (TIW) for up to 52 weeks in the extension study. Etelcalcetide dose could be increased at weeks 5, 9, 17, 25, 33, 41, and 49 to a maximum dose of 15 mg to achieve predialysis serum parathyroid hormone levels ≤ 300 pg/mL.
710980|NCT01785849|B3|Baseline|Total|Total of all reporting groups
710981|NCT01785849|B2|Baseline|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710982|NCT01785849|B1|Baseline|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710983|NCT01785849|P2|Participant Flow|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710984|NCT01785849|P1|Participant Flow|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
711088|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
710985|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710986|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710987|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710988|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710989|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710990|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710991|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710992|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710993|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710994|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710995|NCT01785849|O2|Outcome|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710996|NCT01785849|O1|Outcome|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710997|NCT01785849|E2|Reported Event|Etelcalcetide|Participants received etelcalcetide administered by intravenous bolus injection at the end of each hemodialysis session, TIW, for 26 weeks. The starting dose was 5 mg and may have been increased at weeks 5, 9, 13 and 17 to achieve a predialysis PTH ≤ 300 pg/mL.
710998|NCT01785849|E1|Reported Event|Placebo|Participants received placebo administered by intravenous bolus injection at the end of each hemodialysis session, three times per week (TIW) for 26 weeks.
710999|NCT01785628|B3|Baseline|Total|Total of all reporting groups
711000|NCT01785628|B2|Baseline|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711001|NCT01785628|B1|Baseline|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711002|NCT01785628|P2|Participant Flow|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711003|NCT01785628|P1|Participant Flow|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711004|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711005|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711006|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711007|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711008|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711009|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711010|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711011|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711012|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711013|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711014|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711017|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711018|NCT01785628|O2|Outcome|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711019|NCT01785628|O1|Outcome|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711020|NCT01785628|E2|Reported Event|Placebo Capsule|Oral capsules of Placebo (Dextrin 0.5g capsule) 1g / bid for 8 weeks.
711021|NCT01785628|E1|Reported Event|Sarcosine Capsule|Oral capsules of Sarcosine (0.5g capsule) 1g / bid for 8 weeks.
711022|NCT01785615|B4|Baseline|Total|Total of all reporting groups
711023|NCT01785615|B3|Baseline|Healthy Participants|
711024|NCT01785615|B2|Baseline|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711025|NCT01785615|B1|Baseline|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711026|NCT01785615|P4|Participant Flow|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711027|NCT01785615|P3|Participant Flow|Healthy Women|Women without metabolic syndrome
712652|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
711029|NCT01785615|P1|Participant Flow|Atorvastatin|"44 women with metabolic syndrome randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711030|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711031|NCT01785615|O1|Outcome|Healthy Women|
711032|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711033|NCT01785615|O1|Outcome|Healthy Women|
711034|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711035|NCT01785615|O1|Outcome|Healthy Women|
711036|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711037|NCT01785615|O1|Outcome|Healthy Women|
711038|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711039|NCT01785615|O1|Outcome|Healthy Women|
711040|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711041|NCT01785615|O1|Outcome|Healthy Women|
711042|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711043|NCT01785615|O1|Outcome|Healthy Women|
711044|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711045|NCT01785615|O1|Outcome|Healthy Women|
711046|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711047|NCT01785615|O1|Outcome|Healthy Women|
711048|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711049|NCT01785615|O1|Outcome|Healthy Women|
711050|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711051|NCT01785615|O1|Outcome|Healthy Women|
711052|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711053|NCT01785615|O1|Outcome|Healthy Women|
711054|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711055|NCT01785615|O1|Outcome|Healthy Women|
711056|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711057|NCT01785615|O1|Outcome|Healthy Women|
711058|NCT01785615|O2|Outcome|Metabolic Syndrome Women|Women without metabolic syndrome. These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711059|NCT01785615|O1|Outcome|Healthy Women|
711060|NCT01785615|O2|Outcome|Metabolic Syndrome Women|These were women who were later randomized to receive Atorvastatin or placebo during phase 2.
711061|NCT01785615|O1|Outcome|Healthy Women|Women without metabolic syndrome
711062|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711063|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711064|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711065|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711066|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711067|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711068|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711069|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711070|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711071|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711072|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711073|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711074|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711075|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711076|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711077|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711078|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711079|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711080|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711081|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711082|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711083|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711084|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo: 80mg"
711085|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin: 80mg"
711086|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711089|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711090|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711091|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711092|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711093|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711094|NCT01785615|O2|Outcome|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711095|NCT01785615|O1|Outcome|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711096|NCT01785615|E2|Reported Event|Sugar Pill|"44 women randomized to placebo for 6 weeks~Placebo : 80mg"
711097|NCT01785615|E1|Reported Event|Atorvastatin|"44 women randomized to 80 mg atorvastatin for 6weeks~Atorvastatin : 80mg"
711098|NCT01785602|B3|Baseline|Total|Total of all reporting groups
711099|NCT01785602|B2|Baseline|Placebo|Participants received matching placebo to QAW039.
711100|NCT01785602|B1|Baseline|QAW039|Participants received QAW039 450 mg daily by mouth.
711101|NCT01785602|P2|Participant Flow|Placebo|Participants received matching placebo to QAW039.
711102|NCT01785602|P1|Participant Flow|QAW039|Participants received QAW039 450 mg daily by mouth.
711103|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
711104|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
711105|NCT01785602|O2|Outcome|Placebo|Participants received matching placebo to QAW039.
711106|NCT01785602|O1|Outcome|QAW039|Participants received QAW039 450 mg daily by mouth.
711107|NCT01785602|E2|Reported Event|Placebo|Participants received matching placebo to QAW039.
711108|NCT01785602|E1|Reported Event|QAW039|Participants received QAW039 450 mg daily by mouth.
711109|NCT01785524|B3|Baseline|Total|Total of all reporting groups
711110|NCT01785524|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
711111|NCT01785524|B1|Baseline|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
711112|NCT01785524|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
711138|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711139|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711140|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711113|NCT01785524|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
711114|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
711150|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
712653|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
711115|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
711116|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
711117|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
711118|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
711119|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
711141|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711142|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
712374|NCT01778855|O2|Outcome|Hypothermia|IV t-PA and hypothermia
711120|NCT01785524|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
711121|NCT01785524|O1|Outcome|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
711122|NCT01785524|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
711180|NCT01785134|B2|Baseline|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711123|NCT01785524|E1|Reported Event|BR Juice (Beet-It Stamina Shot) & Supervised Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) and Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
711124|NCT01785472|B4|Baseline|Total|Total of all reporting groups
711125|NCT01785472|B3|Baseline|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711126|NCT01785472|B2|Baseline|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711127|NCT01785472|B1|Baseline|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711128|NCT01785472|P3|Participant Flow|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711129|NCT01785472|P2|Participant Flow|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711130|NCT01785472|P1|Participant Flow|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711131|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711132|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711133|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711134|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711135|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711136|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711137|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711143|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711144|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711145|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711146|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711147|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711148|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711149|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711151|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711152|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711153|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711154|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711155|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711156|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711157|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711158|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711159|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711160|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711161|NCT01785472|O3|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711162|NCT01785472|O2|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711163|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711164|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711165|NCT01785472|O1|Outcome|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711166|NCT01785472|O2|Outcome|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily.
711167|NCT01785472|O1|Outcome|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily.
711168|NCT01785472|E3|Reported Event|Olmesartan 20 mg|Patients will be treated with Olmesartan 20 mg for eight weeks once daily along with placebo of LCZ696 tablets once daily
711169|NCT01785472|E2|Reported Event|LCZ696 400 mg|Patients will start with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily (qd) for one week, thereafter all patients in the treatment group will be up-titrated to two LCZ696 200 mg tablets (400 mg of LCZ696) qd for the remaining seven weeks. Placebo of Olmesartan 20 mg capsule once daily also will be taken.
711170|NCT01785472|E1|Reported Event|LCZ696 200 mg|Patients will be treated with one LCZ696 200 mg tablet and one placebo of LCZ696 once daily(qd) for eight weeks along with placebo of Olmesartan 20 mg capsule once daily
711171|NCT01785160|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir The two treatments were separated by washout period of at least 7 days.
711172|NCT01785160|P1|Participant Flow|Overall Study|Total number of patients randomised and treated in the study.This was a open label trial with two periods in a fixed sequence. All subjects were to receive the following 2 treatments, A]Raltegravir B]Raltegravir+Faldaprevir. The two treatments were separated by washout period of at least 7 days.
712375|NCT01778855|O1|Outcome|Normothermia|IV t-PA and normothermia
711173|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules~Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
711174|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets~Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
711175|NCT01785160|O2|Outcome|Raltegravir + Faldaprevir|"Raltegravir coated tablets and Faldaprevir soft gelatin capsules~Oral with 240 mL of water Day 1: 400 mg raltegravir twice daily and 240 mg faldaprevir twice daily (loading dose) Days 2 to 5: 400 mg raltegravir twice daily and 240 mg faldaprevir once daily Day 6: 400 mg raltegravir once daily and 240 mg faldaprevir once daily"
711176|NCT01785160|O1|Outcome|Raltegravir|"Raltegravir coated tablets~Oral with 240 mL of water Days 1 to 3: 400 mg raltegravir twice daily Day 4: 400 mg raltegravir once daily"
711177|NCT01785160|E2|Reported Event|Raltegravir + Faldaprevir|"coated tablets and soft gelatine capsule, oral administration with 240 ml water~Raltegravir: low dose oral administration~Faldaprevir: medium dose oral administration"
711178|NCT01785160|E1|Reported Event|Raltegravir|"coated tablets, oral administration with 240 ml water~Raltegravir: low dose oral administration"
711179|NCT01785134|B3|Baseline|Total|Total of all reporting groups
711181|NCT01785134|B1|Baseline|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711182|NCT01785134|P2|Participant Flow|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711183|NCT01785134|P1|Participant Flow|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711184|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711185|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711186|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711187|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711188|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711189|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711190|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711191|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711192|NCT01785134|O2|Outcome|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711193|NCT01785134|O1|Outcome|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711194|NCT01785134|E2|Reported Event|Omentectomy|"Gastric bypass operation in conjunction with removal of greater omentum~Omentectomy~Gastric bypass operation"
711195|NCT01785134|E1|Reported Event|Control|"Gastric bypass operation without omentectomy.~Gastric bypass operation"
711196|NCT01785095|B1|Baseline|Follicle Stimulating Hormone|
711197|NCT01785095|P1|Participant Flow|Follicle Stimulation Hormone|"FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.~FSH (Follicle Stimulating Hormone)"
711198|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle after 1 month of wash out.
711199|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
711200|NCT01785095|O2|Outcome|Second Cycle|Second treatment cycle performed after 1 month of wash out.
711201|NCT01785095|O1|Outcome|First Cycle|First treatment cycle.
711202|NCT01785095|O1|Outcome|Follicle Stimulationg Hormone|
711203|NCT01785095|E1|Reported Event|Follicle Stimulating Hormone|
711204|NCT01784965|B3|Baseline|Total|Total of all reporting groups
711205|NCT01784965|B2|Baseline|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
711206|NCT01784965|B1|Baseline|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
711207|NCT01784965|P2|Participant Flow|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
711208|NCT01784965|P1|Participant Flow|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
711209|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
711210|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
711211|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Liraglutide: Double Blinded study. Participants will receive a study pen with dosing instructions: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
711340|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711212|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded study. Participants will receive study pen with dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
711213|NCT01784965|O2|Outcome|Liraglutide|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~liraglutide: Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg."
711214|NCT01784965|O1|Outcome|Placebo|"Both groups receive dietary weight loss intervention In addition one group received liraglutide and one group received placebo~Placebo: Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three."
711215|NCT01784965|E2|Reported Event|Placebo|0/33 0/33 0/33 0/33 0/33
711216|NCT01784965|E1|Reported Event|Liraglutide|Intolerable gastrointestinal side effects 3/35 injection site reaction 2/35 pneumonia 1/35 gallstone 1/35 fall 1/35
711217|NCT01784666|B4|Baseline|Total|Total of all reporting groups
711218|NCT01784666|B3|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711219|NCT01784666|B2|Baseline|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711220|NCT01784666|B1|Baseline|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711221|NCT01784666|P3|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711222|NCT01784666|P2|Participant Flow|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711223|NCT01784666|P1|Participant Flow|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711224|NCT01784666|O3|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711225|NCT01784666|O2|Outcome|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711226|NCT01784666|O1|Outcome|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711227|NCT01784666|E3|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the subsequent 4 weeks~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711228|NCT01784666|E2|Reported Event|Placebo -> Isradipine|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or isradipine for the next 4 weeks~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.~Placebo: Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711255|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711256|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
711229|NCT01784666|E1|Reported Event|Isradipine-Isradipine|"Subjects will receive isradipine in phase 1 (4 weeks) and phase 2 (4 weeks)~Isradipine: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed."
711230|NCT01784614|B1|Baseline|Overall|"Single dose of 0.1 mg LY2624803 oral solution plus 1 placebo capsule, one 1.0, 3.0 or 6.0 mg LY2624803 capsule plus placebo solution administered orally in up to 2 of 4 periods or 1 placebo capsule plus placebo solution administered orally in up to 1 of 4 periods.~There was at least 7 days washout between each period."
711231|NCT01784614|P8|Participant Flow|Cohort 8|"Period 1: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of 1.0 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
711232|NCT01784614|P7|Participant Flow|Cohort 7|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
711233|NCT01784614|P6|Participant Flow|Cohort 6|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~Period 4: Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally.~There was at least 7 days washout between each period."
711234|NCT01784614|P5|Participant Flow|Cohort 5|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
711235|NCT01784614|P4|Participant Flow|Cohort 4|"Period 1: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
711236|NCT01784614|P3|Participant Flow|Cohort 3|"Period 1: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
711237|NCT01784614|P2|Participant Flow|Cohort 2|"Period 1: Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 2: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 3: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
711238|NCT01784614|P1|Participant Flow|Cohort 1|"Period 1: Single dose of 1 placebo capsule plus placebo solution administered orally.~Period 2: Single dose of one 1.0 milligram (mg) LY2624803 capsule plus placebo solution administered orally.~Period 3: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~Period 4: Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally.~There was at least 7 days washout between each period."
711239|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
711240|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
711241|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
711242|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
711243|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
711244|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
711245|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4
711246|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4
711247|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711248|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711249|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711250|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711251|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
711252|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711253|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711254|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711257|NCT01784614|O5|Outcome|Placebo|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711258|NCT01784614|O4|Outcome|6.0 mg LY2624803|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711259|NCT01784614|O3|Outcome|3.0 mg LY2624803|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711260|NCT01784614|O2|Outcome|1.0 mg LY2624803|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711261|NCT01784614|O1|Outcome|0.1 mg LY2624803|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
711262|NCT01784614|E9|Reported Event|6 mg LY2624803 - Period 4|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
711263|NCT01784614|E8|Reported Event|3.0 mg LY2624803 - Period 4|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
711264|NCT01784614|E7|Reported Event|1.0 mg LY2624803 - Period 4|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Period 4.
711265|NCT01784614|E6|Reported Event|0.1 mg LY2624803 - Period 4|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Period 4.
711266|NCT01784614|E5|Reported Event|Placebo - Periods 1-3|Single dose of 1 placebo capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711267|NCT01784614|E4|Reported Event|6.0 mg LY2624803 - Periods 1-3|Single dose of one 6.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711268|NCT01784614|E3|Reported Event|3.0 mg LY2624803 - Periods 1-3|Single dose of one 3.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711269|NCT01784614|E2|Reported Event|1.0 mg LY2624803 - Periods 1-3|Single dose of one 1.0 mg LY2624803 capsule plus placebo solution administered orally in Periods 1, 2 and 3.
711270|NCT01784614|E1|Reported Event|0.1 mg LY2624803 - Periods 1-3|Single dose of 0.1 mg LY2624803 solution plus 1 placebo capsule administered orally in Periods 1, 2 and 3.
711271|NCT01783938|B3|Baseline|Total|Total of all reporting groups
711272|NCT01783938|B2|Baseline|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711273|NCT01783938|B1|Baseline|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711274|NCT01783938|P2|Participant Flow|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711301|NCT01783886|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
712376|NCT01778855|E2|Reported Event|Hypothermia|IV t-PA and hypothermia
711275|NCT01783938|P1|Participant Flow|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711276|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711277|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711278|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711279|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711280|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711281|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711302|NCT01783886|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) 2Q4 over 48 weeks.
711303|NCT01783886|P3|Participant Flow|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711341|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711282|NCT01783938|O2|Outcome|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711283|NCT01783938|O1|Outcome|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711293|NCT01783912|O3|Outcome|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
711284|NCT01783938|E2|Reported Event|Ipilimumab Followed by Nivolumab|Participants received ipilimumab solution at 3 milligram/kilogram (mg/kg) intravenously every 3 weeks for up to 4 doses during Weeks 1 to 13 in Induction Period 1, followed by nivolumab solution at 3 mg/kg intravenously every 2 weeks for up to 6 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711285|NCT01783938|E1|Reported Event|Nivolumab Followed by Ipilimumab|Participants received nivolumab solution at 3 milligram/kilogram (mg/kg) intravenously every 2 weeks for up to 6 doses during Weeks 1 to 13 in Induction Period 1, followed by ipilimumab solution at 3 mg/kg intravenously every 3 weeks for up to 4 doses during Weeks 13 to 25 in Induction Period 2. Per protocol, a participant was allowed to permanently discontinue one agent and then receive the other agent. Participants received nivolumab solution at 3 mg/kg intravenously every 2 weeks, starting at week 25 in the continuation period, for a maximum of 2 years from 1st study treatment in Induction Period 1. At end of 2 years, participants who had investigator-assessed benefit and were tolerating therapy were allowed to continue nivolumab therapy in the Extension Period. Regimen followed until disease progression, unacceptable toxicity, or withdrawal of consent. Treatment Period includes induction period 1, 2, continuation, and extension period.
711286|NCT01783912|B4|Baseline|Total|Total of all reporting groups
711287|NCT01783912|B3|Baseline|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
711288|NCT01783912|B2|Baseline|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
711289|NCT01783912|B1|Baseline|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
711304|NCT01783886|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711342|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711290|NCT01783912|P3|Participant Flow|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
711291|NCT01783912|P2|Participant Flow|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
711292|NCT01783912|P1|Participant Flow|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
711313|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711314|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711385|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711294|NCT01783912|O2|Outcome|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
711295|NCT01783912|O1|Outcome|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
711296|NCT01783912|E3|Reported Event|Motivated Smokers Comparison Group|"This arm of the project will address the following question:~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Do participants in the Motivated Smokers Comparison group (identified as motivated to quit upon recruitment) utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~Participants will not receive any intervention but will be consented and enrolled into this group and assessed for utilization of the tobacco quit line services."
711297|NCT01783912|E2|Reported Event|Attention Control Group|"This arm of the project will address the following question:~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate that those who are in the experimental treatment group?~After completion of control individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Cognitive/Motivational Intervention Group?~Attention Control Individual Sessions: Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking."
711298|NCT01783912|E1|Reported Event|Cognitive/Motivational Intervention Group|"This arm of the project will address the following questions:~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Active Control group?~After completion of experimental individual sessions, do the participants in the control group utilize the quit line services at the same, greater or lesser rate than those who are in the Motivated Smokers Comparison group?~Cognitive / Motivational Individual Sessions: Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).~Nicotine Patch: Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks."
711299|NCT01783886|B4|Baseline|Total|Total of all reporting groups
711300|NCT01783886|B3|Baseline|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711305|NCT01783886|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2 milligram (mg) Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711306|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711307|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711308|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711309|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711310|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711311|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711312|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711315|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711316|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711317|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711318|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711319|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711320|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711321|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711322|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711323|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711324|NCT01783886|O3|Outcome|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711325|NCT01783886|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711326|NCT01783886|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711327|NCT01783886|E3|Reported Event|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks over 48 weeks.
711328|NCT01783886|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF Trap-Eye, BAY86-5321) every 4 weeks until Week 16 and every 8 weeks (2Q8) thereafter, over 48 weeks.
711329|NCT01783886|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2 mg Intravitreal aflibercept injection (IAI) (Eylea, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4) over 48 weeks.
711330|NCT01783860|B3|Baseline|Total|Total of all reporting groups
711331|NCT01783860|B2|Baseline|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711332|NCT01783860|B1|Baseline|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711333|NCT01783860|P2|Participant Flow|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711334|NCT01783860|P1|Participant Flow|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711335|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711336|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711337|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711338|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711339|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711343|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711344|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711345|NCT01783860|O2|Outcome|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711346|NCT01783860|O1|Outcome|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711347|NCT01783860|E2|Reported Event|Oral Azithromycin|"Two 250 mg capsules (500 mg) of Azithromycin for the first day and 250mg/day for the next 4 days.~Azithromycin :"
711348|NCT01783860|E1|Reported Event|Doxycycline|"Oral doxycycline 100mg capsule every 12 hours for one month~Doxycycline :"
711349|NCT01783821|B3|Baseline|Total|Total of all reporting groups
711350|NCT01783821|B2|Baseline|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711351|NCT01783821|B1|Baseline|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711352|NCT01783821|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711353|NCT01783821|P1|Participant Flow|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711354|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711355|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711356|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711357|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711358|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711359|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711360|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711361|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711362|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711363|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711364|NCT01783821|O2|Outcome|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711365|NCT01783821|O1|Outcome|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711366|NCT01783821|E2|Reported Event|Placebo|Subjects randomized to this arm will receive normal saline, the quantity, appearance and timing of the doses the same as the intervention arm.
711367|NCT01783821|E1|Reported Event|Budesonide and Formoterol|Subjects randomized to this arm will receive combined standard aerosolized doses of budesonide (0.5 mg) and formoterol (20 mcg) twice daily, with at least 6 hours between doses, for 5 days for a total of 10 doses or until hospital discharge or death, with the first dose administered as soon as possible following randomization but not later than 4 hours.
711368|NCT01783730|B1|Baseline|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711369|NCT01783730|P1|Participant Flow|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711370|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711371|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711372|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711373|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711507|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
711374|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711375|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711376|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711377|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711378|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711379|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711380|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711381|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711382|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711383|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711384|NCT01783730|O1|Outcome|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711386|NCT01783730|E1|Reported Event|Participants With High Rheumatoid Arthritis Disease Activity|Participants who received adalimumab treatment
711387|NCT01783678|B7|Baseline|Total|Total of all reporting groups
711388|NCT01783678|B6|Baseline|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711389|NCT01783678|B5|Baseline|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711390|NCT01783678|B4|Baseline|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711391|NCT01783678|B3|Baseline|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711392|NCT01783678|B2|Baseline|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711393|NCT01783678|B1|Baseline|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711394|NCT01783678|P6|Participant Flow|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711395|NCT01783678|P5|Participant Flow|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711396|NCT01783678|P4|Participant Flow|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711397|NCT01783678|P3|Participant Flow|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711398|NCT01783678|P2|Participant Flow|Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711399|NCT01783678|P1|Participant Flow|Genotype 2 Treatment-naive|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711400|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711401|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711402|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711403|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711404|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711405|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711406|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711407|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711408|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711409|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
712377|NCT01778855|E1|Reported Event|Normothermia|IV t-PA and normothermia
711410|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711411|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711412|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711413|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711414|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711415|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711416|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711417|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711418|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711419|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711420|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711421|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711422|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711423|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711424|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711425|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711426|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711427|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711428|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711429|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711430|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711431|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711432|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711433|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711434|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711435|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711436|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711437|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711438|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
712378|NCT01778751|B3|Baseline|Total|Total of all reporting groups
711439|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711440|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711441|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711442|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711443|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711444|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711445|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711446|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711447|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711448|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711449|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711450|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711451|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711452|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711453|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711454|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711455|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711456|NCT01783678|O3|Outcome|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
711457|NCT01783678|O2|Outcome|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
711458|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711459|NCT01783678|O8|Outcome|Genotype 4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 4 HCV coinfection
711460|NCT01783678|O7|Outcome|Genotype 3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 3 HCV coinfection
711461|NCT01783678|O6|Outcome|Genotype 3 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 3 HCV coinfection
711462|NCT01783678|O5|Outcome|Genotype 2 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 HCV coinfection
711463|NCT01783678|O4|Outcome|Genotype 1b Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1b HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711464|NCT01783678|O3|Outcome|Genotype 1a Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1a HCV coinfection (subset of All Genotype 1 Treatment-naive reporting group)
711465|NCT01783678|O2|Outcome|All Genotype 1 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1 HCV coinfection
711466|NCT01783678|O1|Outcome|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711467|NCT01783678|E3|Reported Event|Genotype 1/3/4 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-naive participants with HIV-1 and genotype 1, 3, or 4 HCV coinfection
711508|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
711468|NCT01783678|E2|Reported Event|Genotype 2/3 Treatment-experienced|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks in treatment-experienced participants with HIV-1 and genotype 2 or 3 HCV coinfection
711469|NCT01783678|E1|Reported Event|Genotype 2 Treatment-naive|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks in treatment-naive participants with HIV-1 and genotype 2 HCV coinfection
711470|NCT01783639|B1|Baseline|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
711471|NCT01783639|P1|Participant Flow|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
711472|NCT01783639|O1|Outcome|Arm 1|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
711473|NCT01783639|E1|Reported Event|WIRION|"Device: WIRION™ Embolic Protection System~Interventions: Carotid Artery Stent~Carotid Artery Stent: Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices"
711474|NCT01783548|B3|Baseline|Total|Total of all reporting groups
712654|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
711475|NCT01783548|B2|Baseline|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
711476|NCT01783548|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
711477|NCT01783548|P2|Participant Flow|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
711478|NCT01783548|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
711479|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
711480|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
711481|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
711482|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
711483|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
711484|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
711485|NCT01783548|O2|Outcome|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
711486|NCT01783548|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
711487|NCT01783548|E2|Reported Event|Placebo Nasal Aerosol|Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
711488|NCT01783548|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period.
711489|NCT01783496|B7|Baseline|Total|Total of all reporting groups
711490|NCT01783496|B6|Baseline|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
711491|NCT01783496|B5|Baseline|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
711492|NCT01783496|B4|Baseline|Total Tip|Treatment with the Thermage CPT Total tip
711493|NCT01783496|B3|Baseline|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
711494|NCT01783496|B2|Baseline|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
711495|NCT01783496|B1|Baseline|Framed Tip|Treatment with Thermage CPT Framed Tip
711496|NCT01783496|P6|Participant Flow|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
711497|NCT01783496|P5|Participant Flow|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
711498|NCT01783496|P4|Participant Flow|Total Tip|Treatment with the Thermage CPT Total tip
711499|NCT01783496|P3|Participant Flow|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip Using Staggered-Pass Technique
711500|NCT01783496|P2|Participant Flow|Pattern Tip|Treatment with the Thermage CPT Pattern Tip Using Super-Pass Technique
711501|NCT01783496|P1|Participant Flow|Framed Tip|Treatment with Thermage CPT Framed Tip
711502|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
711503|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
711504|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
711505|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
711506|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
711509|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
711510|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
711511|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
711512|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
711513|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
711514|NCT01783496|O6|Outcome|Total and Patterned Tip|Split face treatment with the Thermage CPT Total and Patterned tips
711515|NCT01783496|O5|Outcome|Framed and Patterned Tip|Split face treatment with the Thermage CPT Framed and Patterned tips
711516|NCT01783496|O4|Outcome|Total Tip|Treatment with the Thermage CPT Total tip
711517|NCT01783496|O3|Outcome|Pattern Tip Group 2|Treatment with the Thermage CPT Pattern tip
711518|NCT01783496|O2|Outcome|Pattern Tip|Treatment with the Thermage CPT Pattern Tip
711519|NCT01783496|O1|Outcome|Framed Tip|Treatment with Thermage CPT Framed Tip
711520|NCT01783496|E6|Reported Event|Total and Patterned Tip|"Split face treatment with the Thermage CPT Total and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
711521|NCT01783496|E5|Reported Event|Framed and Patterned Tip|"Split face treatment with the Thermage CPT Framed and Patterned tips~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
712655|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
711522|NCT01783496|E4|Reported Event|Total Tip|"Treatment with the Thermage CPT Total tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
711523|NCT01783496|E3|Reported Event|Pattern Tip Group 2|"Treatment with the Thermage CPT Pattern tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
711524|NCT01783496|E2|Reported Event|Pattern Tip|"Treatment with the Thermage CPT Pattern Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
711525|NCT01783496|E1|Reported Event|Framed Tip|"Treatment with Thermage CPT Framed Tip~Thermage CPT: Treatment with Thermage patterned, total, or framed tip"
711526|NCT01783470|B1|Baseline|All Participants|All participants randomized to placebo or drug first then received the other treatment second.
711527|NCT01783470|P2|Participant Flow|beta3-adrenergic Receptor (AR) Agonist Then Placebo|Participants administered an oral beta3-AR agonist followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received placebo.
711528|NCT01783470|P1|Participant Flow|Placebo Then beta3-adrenergic Receptor (AR) Agonist|Participants administered a lactose-based oral placebo followed by administration of the PET tracer FDG and then PET/CT scanning. On a subsequent day that was at least 48 hours later (for washout purposes) these subjects then received drug.
711529|NCT01783470|O2|Outcome|beta3-adrenergic Receptor (AR)|
711530|NCT01783470|O1|Outcome|Placebo|"lactose~Placebo"
711531|NCT01783470|E3|Reported Event|Mild Cold Exposure|2 hours while wearing a cooling vest with water set to 14-16 C. This arm was before randomization and had 15 participants.
711532|NCT01783470|E2|Reported Event|beta3-adrenergic Receptor Agonist|"single dose~beta3-adrenergic receptor agonist: single dose"
711533|NCT01783470|E1|Reported Event|Placebo|"lactose~Placebo"
711534|NCT01783418|B3|Baseline|Total|Total of all reporting groups
711535|NCT01783418|B2|Baseline|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711536|NCT01783418|B1|Baseline|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711537|NCT01783418|P2|Participant Flow|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711538|NCT01783418|P1|Participant Flow|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711539|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711540|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711541|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711542|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711543|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711544|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711545|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711546|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711547|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711548|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711549|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711550|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711551|NCT01783418|O2|Outcome|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711552|NCT01783418|O1|Outcome|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711553|NCT01783418|E2|Reported Event|No Treatment Control|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711554|NCT01783418|E1|Reported Event|Mindfulness Intervention|Mindfulness Intervention: Mindfulness-based intervention adapted for teenagers
711555|NCT01783236|B3|Baseline|Total|Total of all reporting groups
711556|NCT01783236|B2|Baseline|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711582|NCT01783015|B2|Baseline|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711557|NCT01783236|B1|Baseline|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711558|NCT01783236|P2|Participant Flow|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711559|NCT01783236|P1|Participant Flow|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711560|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711561|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711562|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711593|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711563|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711564|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711565|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711566|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711567|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711568|NCT01783236|O2|Outcome|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711569|NCT01783236|O1|Outcome|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711570|NCT01783236|E2|Reported Event|IV Acetaminophen|"Subjects will receive an infusion of 1 g of intravenous acetaminophen administered over 15 minutes every 6 hours for 24 hours with a maximum dose of 4 grams.~IV Acetaminophen: 1000mg IV Ofirmev given every six hours for a total of four doses."
711571|NCT01783236|E1|Reported Event|Saline Placebo|"Subjects will receive a saline placebo infusion administered over 15 minutes every 6 hours for 24 hours.~Saline Placebo: Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm."
711572|NCT01783054|B1|Baseline|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711573|NCT01783054|P1|Participant Flow|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711574|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711575|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711576|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711577|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711578|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711579|NCT01783054|O1|Outcome|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711580|NCT01783054|E1|Reported Event|Chemotherapy, Surgery|All subjects enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Gemcitabine and abraxane will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks, then surgery.
711581|NCT01783015|B3|Baseline|Total|Total of all reporting groups
711583|NCT01783015|B1|Baseline|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711584|NCT01783015|P3|Participant Flow|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711585|NCT01783015|P2|Participant Flow|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711586|NCT01783015|P1|Participant Flow|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711587|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711588|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711589|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711590|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711591|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711592|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711594|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711595|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711596|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711597|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711598|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711599|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711600|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711601|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711602|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711603|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711604|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711605|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711606|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711607|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711608|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711609|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711610|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711611|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711612|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711613|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711614|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711615|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711616|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711617|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711618|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711619|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711620|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711621|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711622|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711623|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711624|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711625|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
716467|NCT01761279|P1|Participant Flow|HDWL and i-Scan Assessment|High Definition White Light Endoscopy.
711626|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711627|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711628|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711629|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711630|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711631|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711632|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711633|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711634|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711635|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
712656|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
711636|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711637|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711638|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711639|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711640|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711641|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711642|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711643|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711644|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711645|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711646|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711647|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711648|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711649|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711650|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711651|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711652|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711653|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711654|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711655|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711656|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711657|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711658|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711659|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711660|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711661|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711662|NCT01783015|O3|Outcome|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711663|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711664|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711665|NCT01783015|O2|Outcome|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711666|NCT01783015|O1|Outcome|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711667|NCT01783015|E3|Reported Event|Period 2 - Open Label Treatment|Participants received etanercept 50 mg subcutaneously with oral methotrexate 10 to 25 mg once-weekly.
711668|NCT01783015|E2|Reported Event|Period I - Blinded Treatment - Placebo|Participants received placebo injections with oral methotrexate tablets once-weekly.
711669|NCT01783015|E1|Reported Event|Period I - Blinded Treatment - Etanercept|Participants received etanercept 50 mg subcutaneously with oral methotrexate tablets once-weekly.
711670|NCT01782898|B3|Baseline|Total|Total of all reporting groups
711671|NCT01782898|B2|Baseline|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
711672|NCT01782898|B1|Baseline|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
711673|NCT01782898|P2|Participant Flow|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
711674|NCT01782898|P1|Participant Flow|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
712657|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
711675|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
711676|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
711677|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
711678|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
711679|NCT01782898|O2|Outcome|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
711680|NCT01782898|O1|Outcome|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
711681|NCT01782898|E2|Reported Event|.9 Normal Saline|".9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,~Placebo Comparator: .9 normal saline: Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,"
711682|NCT01782898|E1|Reported Event|Esmolol|"Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min~Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min: Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min"
711683|NCT01782885|B3|Baseline|Total|Total of all reporting groups
711684|NCT01782885|B2|Baseline|Intra-articular Injection of PRP|Intra-articular injection of PRP: Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks treatment).
711685|NCT01782885|B1|Baseline|Acetaminophen|Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) during 6 weeks.
711686|NCT01782885|P2|Participant Flow|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711687|NCT01782885|P1|Participant Flow|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711688|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711689|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711690|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711691|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711692|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711693|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711694|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711695|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711696|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711697|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711763|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711698|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711699|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711700|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711701|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711702|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711703|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711704|NCT01782885|O2|Outcome|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711705|NCT01782885|O1|Outcome|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711706|NCT01782885|E2|Reported Event|Intra-articular Injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks of treatment).
711707|NCT01782885|E1|Reported Event|Acetaminophen|Patients from this arm will receive a dose of acetaminophen (500 mg/8 hours) during 6 weeks.
711708|NCT01782872|B5|Baseline|Total|Total of all reporting groups
711709|NCT01782872|B4|Baseline|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
711710|NCT01782872|B3|Baseline|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711711|NCT01782872|B2|Baseline|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711712|NCT01782872|B1|Baseline|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
711713|NCT01782872|P4|Participant Flow|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
711714|NCT01782872|P3|Participant Flow|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711715|NCT01782872|P2|Participant Flow|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711716|NCT01782872|P1|Participant Flow|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
711717|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
711718|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711719|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711720|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
711721|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
711722|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711723|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711724|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
711725|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
711726|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711727|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711728|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
711729|NCT01782872|O4|Outcome|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
711730|NCT01782872|O3|Outcome|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711731|NCT01782872|O2|Outcome|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711732|NCT01782872|O1|Outcome|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
711733|NCT01782872|E4|Reported Event|Control|Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
711734|NCT01782872|E3|Reported Event|Low Dose|Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711735|NCT01782872|E2|Reported Event|Medium Dose|Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
711736|NCT01782872|E1|Reported Event|High Dose|Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
711737|NCT01782859|B3|Baseline|Total|Total of all reporting groups
711805|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711738|NCT01782859|B2|Baseline|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
711739|NCT01782859|B1|Baseline|Placebo|"Control group~Placebo (for Prednisone)"
711740|NCT01782859|P2|Participant Flow|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
711741|NCT01782859|P1|Participant Flow|Placebo|"Control group~Placebo (for Prednisone)"
711742|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV~Prednisone~Hydrocortisone"
711743|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
711744|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
711745|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
711746|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
711747|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
711748|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
711749|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
711750|NCT01782859|O2|Outcome|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
711751|NCT01782859|O1|Outcome|Placebo|"Control group~Placebo (for Prednisone)"
711752|NCT01782859|E2|Reported Event|Prednisone/Hydrocortisone|"Steroid group will receive the following:~20 mg prednisone pill to be taken in the morning of surgery prior to arrival to the hospital~100 mg hydrocortisone IV 8 hours after first dose of prednisone followed by 3. Second and last dose of 100 mg hydrocortisone IV"
711753|NCT01782859|E1|Reported Event|Placebo|"Control group~Placebo (for Prednisone)"
711754|NCT01782742|B3|Baseline|Total|Total of all reporting groups
711755|NCT01782742|B2|Baseline|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711756|NCT01782742|B1|Baseline|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711757|NCT01782742|P2|Participant Flow|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711758|NCT01782742|P1|Participant Flow|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711759|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711760|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711761|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711762|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711764|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711765|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711766|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711767|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711768|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711769|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711770|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711806|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711771|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711772|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711773|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711774|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711775|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711776|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711777|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711778|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711779|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711780|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711781|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711782|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711783|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711784|NCT01782742|O2|Outcome|Placebo|1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.
711785|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711786|NCT01782742|O2|Outcome|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711787|NCT01782742|O1|Outcome|Bexarotene|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711788|NCT01782742|E2|Reported Event|Placebo|"1 placebo capsule BID for week 1, then increasing to 2 placebo capsules BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Placebo"
711789|NCT01782742|E1|Reported Event|Bexarotene Treatment Arm|"75 mg of Bexarotene BID for week 1, then increasing to 150 mg BID for weeks 2 to 4.~Weeks 5 to 8 is Open-label phase (150 mg BID for 4 weeks)~Bexarotene: Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo"
711790|NCT01782482|B3|Baseline|Total|Total of all reporting groups
711791|NCT01782482|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711792|NCT01782482|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711793|NCT01782482|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711794|NCT01782482|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711850|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711795|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711796|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711797|NCT01782482|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711798|NCT01782482|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711799|NCT01782482|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711800|NCT01782482|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn on a daily wear basis for 7 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
711801|NCT01782469|B1|Baseline|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711802|NCT01782469|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711803|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711804|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711807|NCT01782469|O1|Outcome|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711808|NCT01782469|E1|Reported Event|Rheumatoid Arthritis (RA) Participants|Male or female participants at least 18 years of age with diagnosis of RA
711809|NCT01782326|B3|Baseline|Total|Total of all reporting groups
711810|NCT01782326|B2|Baseline|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711811|NCT01782326|B1|Baseline|QVA149|QVA149 (110/50 μg) once daily
711812|NCT01782326|P2|Participant Flow|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711813|NCT01782326|P1|Participant Flow|QVA149|QVA149 (110/50 μg) once daily
711814|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711815|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711816|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711817|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711818|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711819|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711820|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711821|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711822|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711823|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711824|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711825|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711826|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711827|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711828|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711829|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711830|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711831|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711832|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711833|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711834|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711835|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711836|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711837|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711838|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711839|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711840|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711841|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711842|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711843|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711844|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711845|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711846|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711847|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711848|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711849|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711851|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711852|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711853|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711854|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711855|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711856|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711857|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711858|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711859|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711860|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711861|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711862|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711863|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711864|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711865|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711866|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711867|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711868|NCT01782326|O2|Outcome|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711869|NCT01782326|O1|Outcome|QVA149|QVA149 (110/50 μg) once daily
711870|NCT01782326|E2|Reported Event|Long Acting B2 Agonist (LABA) and Inhaled Corticosteroid (ICS)|Salmeterol/fluticasone (50/500μg) twice a day
711871|NCT01782326|E1|Reported Event|QVA149|QVA149 (110/50 μg) once daily
711872|NCT01782222|B4|Baseline|Total|Total of all reporting groups
711873|NCT01782222|B3|Baseline|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711874|NCT01782222|B2|Baseline|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711875|NCT01782222|B1|Baseline|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711876|NCT01782222|P3|Participant Flow|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711877|NCT01782222|P2|Participant Flow|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711878|NCT01782222|P1|Participant Flow|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711879|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711880|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711881|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711882|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711899|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
716468|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
711883|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711884|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711885|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711886|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
712658|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
711887|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711888|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711889|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711890|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711891|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711892|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711893|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711894|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711895|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711896|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711897|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711898|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
716469|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
711900|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711901|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711902|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711903|NCT01782222|O3|Outcome|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711904|NCT01782222|O2|Outcome|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~The maximum Rotigotine dose allowed was 8 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711905|NCT01782222|O1|Outcome|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711906|NCT01782222|E3|Reported Event|Rotigotine, High Dose|"Rotigotine, transdermal patches, maximal 16 mg / 24 hours for patients with advanced Parkinson's Disease and 8 mg / 24 hours for those with early Parkinson's Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711907|NCT01782222|E2|Reported Event|Rotigotine, Low Dose|"Rotigotine, transdermal patches, optimal dose, maximal 8 mg / 24 hours for patients with advanced Parkinson’s Disease and 6 mg / 24 hours for those with early Parkinson’s Disease~Rotigotine: Rotigotine, transdermal patches:~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)~Optimal dosage:~The maximum Rotigotine dose allowed was 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
711908|NCT01782222|E1|Reported Event|Placebo|"Placebo transdermal patches~Placebo: Placebo, matching transdermal patches~Duration: up to 21 weeks (including de-escalation)"
711909|NCT01781962|B1|Baseline|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
711910|NCT01781962|P1|Participant Flow|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
711911|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
711912|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
711913|NCT01781962|O1|Outcome|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
711914|NCT01781962|E1|Reported Event|All Participants|Open-Angle Glaucoma (OAG) and/or Ocular Hypertension (OHT) patients.
711915|NCT01781637|B3|Baseline|Total|Total of all reporting groups
711916|NCT01781637|B2|Baseline|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
711917|NCT01781637|B1|Baseline|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
711918|NCT01781637|P2|Participant Flow|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
711919|NCT01781637|P1|Participant Flow|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
711920|NCT01781637|O2|Outcome|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
711921|NCT01781637|O1|Outcome|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
711922|NCT01781637|O2|Outcome|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
711923|NCT01781637|O1|Outcome|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
711924|NCT01781637|E2|Reported Event|Placebo|"Patients will receive placebo.~placebo: subcutaneous injection"
711925|NCT01781637|E1|Reported Event|Omalizumab Group|"Patients will receive omalizumab.~Omalizumab: subcutaneous injection"
711926|NCT01781481|B1|Baseline|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711927|NCT01781481|P1|Participant Flow|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of Inflammatory Bowel Disease (IBD).
711928|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711929|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711930|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711931|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711932|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711976|NCT01781481|O2|Outcome|Score of 1|Rating of 1 (Mild Vulnerability/Need for watchful waiting or preventive intervention) on Pediatric INTERMED item.
711933|NCT01781481|O6|Outcome|Vulnerability Health System Item: Health System Impediments|This item anticipates the problems that the child/youth may encounter in the next 3-6 months in receiving the services he/she requires.
711934|NCT01781481|O5|Outcome|Current Health System Item: Coordination of Care|This item describes the extent to which the different health care providers working with the child are in contact with each other.
711935|NCT01781481|O4|Outcome|Current Health System Item: Organization of Care|This item describes the nature and organization of the health care services that the child is current receiving.
711936|NCT01781481|O3|Outcome|Historical Health System Item: Treatment Experience|This item describes the degree to which the child and family's prior health care experiences have been positive in terms of good outcomes and relationships with health care providers.
711937|NCT01781481|O2|Outcome|Historical Health System Item: Access to Health Care|This item refers to anything in the past that served as an obstacle, hindering the patient's access to healthcare.
711938|NCT01781481|O1|Outcome|Pediatric Intermed: Health System Domain Score|Sum of Pediatric INTERMED health system item scores.
711939|NCT01781481|O2|Outcome|CBCL Externalizing Score in the Non-clinical Range|Children whose scores on the CBCL Externalizing Scale fell below the clinical range.
711940|NCT01781481|O1|Outcome|CBCL Externalizing Score in the Clinical Range.|Children whose scores on the CBCL Externalizing scale fell within the clinical range.
711941|NCT01781481|O2|Outcome|CBCL Internalizing Score in the Non-clinical Range|Children's whose scores on the CBCL Internalizing Scale fell below the clinical range.
711942|NCT01781481|O1|Outcome|CBCL Internalizing Score in the Clinical Range.|Children whose scores on the CBCL Internalizing Scale fell within the clinical range.
711943|NCT01781481|O2|Outcome|Subjects With CDI Scores in the Non-clinical Range|Children whose scores on the Children's Depression Inventory fell below the clinical range.
711944|NCT01781481|O1|Outcome|Subjects With CDI Scores in the Clinical Range.|Children whose scores on the Children's Depression Inventory fell within the clinical range.
711945|NCT01781481|O2|Outcome|Subjects With MASC Scores in the Non-clinical Range|Children whose scores on the Multidimensional Anxiety Scale for Children fell below the clinical range.
711946|NCT01781481|O1|Outcome|Subjects With MASC Scores in the Clinical Range.|Children whose scores on the Multidimensional Anxiety Scale for Children fell within the clinical range.
711947|NCT01781481|O3|Outcome|Pediatric INTERMED Caregiver/Family Domain Score|Sum of Pediatric INTERMED Caregiver/Family Domain item scores
711948|NCT01781481|O2|Outcome|Pediatric INTERMED Social Domain Score|Sum of Pediatric INTERMED Social Domain items scores
711949|NCT01781481|O1|Outcome|Pediatric INTERMED Psychological Domain Score|Sum of Pediatric INTERMED Psychological Domain item scores
711950|NCT01781481|O7|Outcome|Vulnerability Biological Item: Complications and Life Threat|This item taps the excepted functional impact of the present medical condition over the next 3-6 months based on the child' condition and experience with similar cases.
711951|NCT01781481|O6|Outcome|Current Biological Item: Therapeutic Complexity|This item taps whether a child's treatment for their disease is clear, unequivocal or non-invasive or requires more complex regimens which are perceived by the patient/caregivers to be time-consuming, demanding or aversive.
711952|NCT01781481|O5|Outcome|Current Biological Item: Diagnostic/Therapeutic Challenge|This item refers to the presence of physical symptoms that result in current diagnostic questions or therapeutic challenges.
711953|NCT01781481|O4|Outcome|Current Biological Item: Symptom Severity|This item taps the severity/acuity of the child's current physical symptoms, and the extent to which they impact on current functioning.
711954|NCT01781481|O3|Outcome|Historical Biological Item: Diagnostic Dilemma|This item taps whether or not the child/youth has been seeking care for physical complaints across a substantial portion of their life and whether or not these complaints have been resolved.
711955|NCT01781481|O2|Outcome|Historical Biological Item: Chronicity|This item taps the extent and chronicity of child's physical health issues.
711956|NCT01781481|O1|Outcome|Pediatric INTERMED Biological Domain Score|Sum of all Pediatric INTERMED Biological domain item scores.
711957|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711958|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711959|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711960|NCT01781481|O1|Outcome|Children/Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711961|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711962|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711963|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711964|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711965|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711966|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711967|NCT01781481|O4|Outcome|Greater Than 5 Years|Greater than 5 years since initial IBD diagnosis.
711968|NCT01781481|O3|Outcome|1 Year-5 Years|1 - 5 years since initial IBD diagnosis.
711969|NCT01781481|O2|Outcome|6 Months-1 Year|6 months to 1 year since initial IBD diagnosis.
711970|NCT01781481|O1|Outcome|Less Than 6 Months|Less than 6 months since initial IBD diagnosis.
711971|NCT01781481|O4|Outcome|Disease Severity: Severe|Disease Severity classified as severe
711972|NCT01781481|O3|Outcome|Disease Severity: Moderate|Disease Severity classified as moderate
711973|NCT01781481|O2|Outcome|Disease Severity: Mild|Disease Severity classified as mild
711974|NCT01781481|O1|Outcome|Disease Severity: Remission/Inactive|Disease Severity classified as in remission/inactive
711975|NCT01781481|O3|Outcome|Score of 2 or 3|Rating of 2 (Moderate Vulnerability/Need for Action or Development of an Intervention Plan) on the Pediatric INTERMED item or Rating of 3 (Severe Vulnerability/Need for Immediate Action of Intensive Action/Plans).
716470|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
711977|NCT01781481|O1|Outcome|Score of 0|Rating of 0 (No Vulnerability/Need for Action) on Pediatric INTERMED Item
711978|NCT01781481|O5|Outcome|Health Service|Sum of Health Service Domain Item Scores
711979|NCT01781481|O4|Outcome|Family/Caregiver|Sum of Family/Caregiver Domain Item Scores
711980|NCT01781481|O3|Outcome|Social|Sum of Social Domain Item Scores
711981|NCT01781481|O2|Outcome|Psychological|Sum of Psychological Domain Item Scores
711982|NCT01781481|O1|Outcome|Biological|Sum of Biological Domain Item Scores
711983|NCT01781481|O1|Outcome|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711984|NCT01781481|E1|Reported Event|Children and Youth With IBD|Children/youth (ages 8-17) with confirmed diagnoses of IBD.
711985|NCT01781403|B1|Baseline|Capecitabine, Temozolomide, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
712013|NCT01781299|E1|Reported Event|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
712201|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
711986|NCT01781403|P3|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 75mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
711987|NCT01781403|P2|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 60mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
711988|NCT01781403|P1|Participant Flow|Capecitabine 825mg/m^2, Temozolomide 45mg/m^2, Radiotherapy|"The total dose of radiotherapy will be 50.4 Gy, with a daily dose of 1.8 Gy administered on 5 days of each week, comprising a total of 45 Gy to the whole pelvis, followed by a 5.4 Gy boost to the primary tumor.~The doses and schedules for capecitabine will be fixed, with only temozolomide being prescribed using a dose-escalation schedule. Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).~Temozolomide: Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD."
711989|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711990|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711991|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711992|NCT01781403|O2|Outcome|Hypermethylated MGMT|MGMT methylation specific PCR: hypermethylated
711993|NCT01781403|O1|Outcome|Unmethylated MGMT|MGMT methylation specific PCR: unmethlyated
711994|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711995|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711996|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711997|NCT01781403|O3|Outcome|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711998|NCT01781403|O2|Outcome|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
711999|NCT01781403|O1|Outcome|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
712000|NCT01781403|E3|Reported Event|Dose Level 3/Recommended Dose|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 75 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
712001|NCT01781403|E2|Reported Event|Dose Level 2|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 60 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
712002|NCT01781403|E1|Reported Event|Dose Level 1|"Capecitabine was given 825 mg/m^2 twice/day during radiotherapy with drug holidays (weekend breaks).~Temozolomide was given 45 mg/m^2 once/day during radiotherapy with drug holidays (weekend breaks)."
712003|NCT01781299|B3|Baseline|Total|Total of all reporting groups
712004|NCT01781299|B2|Baseline|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
712005|NCT01781299|B1|Baseline|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
712006|NCT01781299|P2|Participant Flow|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
712007|NCT01781299|P1|Participant Flow|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
712008|NCT01781299|O2|Outcome|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
712009|NCT01781299|O1|Outcome|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
712010|NCT01781299|O2|Outcome|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
712011|NCT01781299|O1|Outcome|AlloDerm RTU|"Participants within this arm will have the acellular dermal matrix AlloDerm RTU implanted at the time of tissue expander placement.~AlloDerm RTU"
712012|NCT01781299|E2|Reported Event|SurgiMend PRS|"Participants within this arm will have the acellular dermal matrix SurgiMend PRS implanted at the time of tissue expander placement.~SurgiMend PRS"
712659|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
712014|NCT01781208|B1|Baseline|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy for known or suspected (non-neoplastic) liver disease were included in this study. Subjects were between 0-18 years of age.
712015|NCT01781208|P1|Participant Flow|Ultrasound-based Acoustic Radiation Force Impulse (ARFI)|"62 children undergoing clinically ordered ultrasound-directed percutaneous core needle liver biopsy were included. Biopsy was performed for known or suspected (non-neoplastic) liver disease. (One child did not undergo a liver biopsy, so was ineligible and not included in the above total.)~The patients received an additional ultrasound for research purposes that utilized a technique known as ARFI. ARFI, or Acoustic Radiation Force Impulse, uses a transducer which directs sound waves again the liver to measure the stiffness of the tissues."
712016|NCT01781208|O2|Outcome|Children Undergoing Diagnostic ARFI/VTIQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI/VTIQ and liver histologic fibrosis score.
712017|NCT01781208|O1|Outcome|Children Undergoing Diagnostic ARFI/VTQ and Fibrosis Scoring|We measured correlation between liver shear wave speed as determined by ARFI (VTQ) and liver histologic fibrosis score.
712018|NCT01781208|E1|Reported Event|All Participants|No serious or non-serious adverse events were observed during the study.
712019|NCT01781169|B3|Baseline|Total|Total of all reporting groups
712020|NCT01781169|B2|Baseline|Obese Group|
712021|NCT01781169|B1|Baseline|Normal-weight Group|
712022|NCT01781169|P2|Participant Flow|Normal-weight Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
712023|NCT01781169|P1|Participant Flow|Obese Group|Oral supplementation of vitamin D (cholecalciferol), 50000 IU/wk for 8 weeks.
712024|NCT01781169|O2|Outcome|Normal-weight Group|Oral supplementation of vitamin D.
712025|NCT01781169|O1|Outcome|Obese Group|Oral supplementation of vitamin D.
712026|NCT01781169|E2|Reported Event|Obese Group|
712027|NCT01781169|E1|Reported Event|Normal-weight Group|
712028|NCT01781078|B3|Baseline|Total|Total of all reporting groups
712029|NCT01781078|B2|Baseline|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
712030|NCT01781078|B1|Baseline|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
712031|NCT01781078|P3|Participant Flow|Patients Withdrawn Prior to Randomization|Patients who consented to the study but were withdrawn prior to the randomization.
712032|NCT01781078|P2|Participant Flow|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
712033|NCT01781078|P1|Participant Flow|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
712034|NCT01781078|O1|Outcome|All Subjects Who Underwent an Implant Procedure|All subjects who underwent an implant procedure and reached 91 days of follow-up.
712035|NCT01781078|O2|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
712036|NCT01781078|O1|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
712037|NCT01781078|O2|Outcome|Control Group|"Those subjects randomized to the Control Group will not undergo study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
712038|NCT01781078|O1|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
712062|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712039|NCT01781078|O1|Outcome|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
712040|NCT01781078|E2|Reported Event|Control Group|"Those subjects randomized to the Control Group will not undergo s study-specific MRI scan. All follow-up time requirements are the same for the two groups.~ImageReady System implant: Pacemaker and lead(s) implant"
712041|NCT01781078|E1|Reported Event|MRI Group|"Those subjects randomized to the MRI Group will undergo a study-specific MRI scan 6-9 weeks post-implant.~MRI: The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment~ImageReady System implant: Pacemaker and lead(s) implant"
712042|NCT01781026|B1|Baseline|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
712043|NCT01781026|P1|Participant Flow|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
712044|NCT01781026|O1|Outcome|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
712045|NCT01781026|E1|Reported Event|Vemurafenib Administration|Vemurafenib 960 mg orally, twice a day
712046|NCT01780987|B3|Baseline|Total|Total of all reporting groups
712047|NCT01780987|B2|Baseline|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712660|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
712048|NCT01780987|B1|Baseline|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712049|NCT01780987|P2|Participant Flow|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712050|NCT01780987|P1|Participant Flow|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712051|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712052|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712053|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712054|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712055|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712056|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712057|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712058|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712059|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712060|NCT01780987|O1|Outcome|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712061|NCT01780987|O2|Outcome|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
716471|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
712063|NCT01780987|E2|Reported Event|Unfractionated Heparin (UFH)/Warfarin|UFH was administrated by continuous intravenous infusion to bring the activated partial thromboplastin time (APTT) to between 1.5 and 2.5 times the control level, until the effect of warfarin stabilized. UFH was administrated at least 5 days unless international normalized ratio (INR) ≥ 2.0 was reached before Day 5. The appropriate dose of warfarin potassium to achieve the target INR range between 1.5 and 2.5 was administrated for 24 weeks.
712064|NCT01780987|E1|Reported Event|Apixaban|Two apixaban 5 mg tablets were administrated twice a day (morning and evening) for 7 days followed by one apixaban 5 mg tablet administrated twice a day (morning and evening) for 23 weeks.
712065|NCT01780974|B3|Baseline|Total|Total of all reporting groups
712066|NCT01780974|B2|Baseline|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
712067|NCT01780974|B1|Baseline|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
712068|NCT01780974|P2|Participant Flow|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
712069|NCT01780974|P1|Participant Flow|Placebo|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
712070|NCT01780974|O2|Outcome|Lipoic Acid Plus Omega-3 Fatty Acids|"Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.~Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate"
712661|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
712071|NCT01780974|O1|Outcome|Placebo|"Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.~Placebo: placebo capsules"
712072|NCT01780974|O2|Outcome|Lipoic Acid Plus Omega-3 Fatty Acids|"Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg DHA and 975 mg EPA plus 2 lipoic acid capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.~Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate"
712073|NCT01780974|O1|Outcome|Placebo|"Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo lipoic acid capsules per day. Capsules will be taken with food or a meal.~Placebo: placebo capsules"
712074|NCT01780974|E2|Reported Event|Lipoic Acid Plus Omega-3 Fatty Acids|Lipoic Acid plus Omega-3 Fatty Acids: alpha lipoic acid (racemic) and fish oil concentrate
712075|NCT01780974|E1|Reported Event|Placebo|placebo capsules
712076|NCT01780935|B3|Baseline|Total|Total of all reporting groups
712077|NCT01780935|B2|Baseline|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712078|NCT01780935|B1|Baseline|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712079|NCT01780935|P2|Participant Flow|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712080|NCT01780935|P1|Participant Flow|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712081|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712082|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712083|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712084|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712085|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712086|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712087|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712088|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712089|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712090|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712091|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712092|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712093|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712094|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712095|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712096|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712097|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712098|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712099|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712100|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712101|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712102|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712103|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712104|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712105|NCT01780935|O2|Outcome|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712106|NCT01780935|O1|Outcome|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712107|NCT01780935|E2|Reported Event|RBZ 0.5 mg: VA and/or OCT (Group II)|RBZ 0.5 mg: VA and/or OCT (Group II) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA)loss due to neovascular (wet) age-related macular degeneration (nAMD) and/or signs of wet AMD disease activity on optical coherence tomography (OCT).
712108|NCT01780935|E1|Reported Event|RBZ 0.5 mg: VA Only (Group I)|RBZ 0.5 mg: Visual Acuity (VA) only (Group I) 0.5 mg intravitreal injections of ranibizumab with retreatment based on best-corrected visual acuity (BCVA) loss due to neovascular (wet) age-related macular degeneration (nAMD)
712109|NCT01780922|B1|Baseline|All Study Participants|All study participants: all participants received all interventions
712110|NCT01780922|P6|Participant Flow|Placebo First, Then CLEB, Then LCJC|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
712111|NCT01780922|P5|Participant Flow|Placebo First, Then LCJC, Then CLEB|First Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
716472|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
712112|NCT01780922|P4|Participant Flow|CLEB First, Then Placebo, Then LCJC|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
712113|NCT01780922|P3|Participant Flow|CLEB First, Then LCJC, Then Placebo|First Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
712114|NCT01780922|P2|Participant Flow|LCJC First, Then Placebo, Then CLEB|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
712115|NCT01780922|P1|Participant Flow|LCJC First, Then CLEB, Then Placebo|First Intervention (1 day) - Low Calorie Cranberry Juice Cocktail (LCJC): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Second Intervention (1 day) - Cranberry Leaf Extract Beverage (CLEB): Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes Washout (7 days) Third Intervention (1 day) - Placebo: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
712116|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712117|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712118|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712119|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712120|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712121|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712122|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712123|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712124|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712125|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712126|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712127|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712128|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712129|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712130|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712131|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712132|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712133|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712134|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712135|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712136|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712137|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712138|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712139|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712140|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712141|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712142|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712143|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712144|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712145|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712146|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712147|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712148|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712149|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712150|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712151|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712152|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712153|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712154|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712155|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712156|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712157|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712158|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712159|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712160|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712161|NCT01780922|O3|Outcome|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712162|NCT01780922|O2|Outcome|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712229|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712163|NCT01780922|O1|Outcome|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712164|NCT01780922|E3|Reported Event|Non-Cranberry Beverage|"Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes~Non-Cranberry Beverage: Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712165|NCT01780922|E2|Reported Event|Cranberry Leaf Extract Beverage|"Beverage containing cranberry leaf extract: one dose of 15.2 ounces consumed within 15 minutes~Cranberry Leaf Extract Beverage: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712166|NCT01780922|E1|Reported Event|Low Calorie Cranberry Juice Cocktail|"Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes~Low Calorie Cranberry Juice Cocktail: Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes"
712167|NCT01780584|B4|Baseline|Total|Total of all reporting groups
712168|NCT01780584|B3|Baseline|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712169|NCT01780584|B2|Baseline|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712170|NCT01780584|B1|Baseline|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712171|NCT01780584|P3|Participant Flow|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712662|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
712172|NCT01780584|P2|Participant Flow|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712173|NCT01780584|P1|Participant Flow|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712174|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712175|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712176|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712177|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712178|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712179|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712180|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712181|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712182|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712183|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712184|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712185|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712186|NCT01780584|O3|Outcome|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712187|NCT01780584|O2|Outcome|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712188|NCT01780584|O1|Outcome|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712189|NCT01780584|E3|Reported Event|Oral T3 High Dose|Oral T3 high dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) q12h starting on induction of anesthesia until 60 hours post-anesthesia (6 doses oral T3)
712190|NCT01780584|E2|Reported Event|Placebo|Placebo (saccharin lactic) administer through nasogastric tube, given starting on induction of anesthesia and then every 12 hours until 60 hours post-anesthesia induction (6 doses total)
712191|NCT01780584|E1|Reported Event|Oral T3 Low Dose|Oral T3 low dose administer through nasogastric tube 0.5 mcg/kg (max 10 mcg) starting on induction of anesthesia and then every 24 hours alternating with placebo, which was given 12 hours after the first dose of oral T3 and then every 24 hours until 60 hours post anesthesia induction (3 doses oral T3, 3 doses placebo)
712192|NCT01780506|B3|Baseline|Total|Total of all reporting groups
712193|NCT01780506|B2|Baseline|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712194|NCT01780506|B1|Baseline|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712195|NCT01780506|P2|Participant Flow|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712196|NCT01780506|P1|Participant Flow|E/C/F/TAF|Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 144 weeks
712197|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712198|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712199|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712200|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712663|NCT01777581|O2|Outcome|Sugar Pill (Placebo)|Placebo
712202|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712203|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712204|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712205|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712206|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712207|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712208|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712209|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712210|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712211|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712212|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712213|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712214|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712215|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712216|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712217|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712218|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712219|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712220|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712221|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712222|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712223|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712224|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712225|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712226|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712227|NCT01780506|O2|Outcome|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712228|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
716473|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
712230|NCT01780506|O1|Outcome|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712231|NCT01780506|E2|Reported Event|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 144 weeks
712232|NCT01780506|E1|Reported Event|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus E/C/F/TDF placebo tablet administered orally once daily for 144 weeks
712233|NCT01780389|B1|Baseline|Milnacipran|Open-label flexibly dosed milnacipran
712234|NCT01780389|P1|Participant Flow|Milnacipran|Open-label flexibly dosed milnacipran
712235|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
712236|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
712237|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
712238|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
712239|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
712240|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
712241|NCT01780389|O1|Outcome|Milnacipran Open Label|Open-label flexibly dosed milnacipran
712242|NCT01780389|O1|Outcome|Milnacipran-Open Label|"Open-label flexibly dosed milnacipran for 12 weeks. Twice-daily dosing will be used and the typical titration schedule will be as follows:~Day 1 - 12.5 mg every morning Day 2-3 - 12.5 mg twice a day Day 4-7 - 25 mg twice a day Day 8-84 - 50 mg twice a day~Taper:~Day 85-88 - 25 mg twice a day Day 89-92 - 12.5 twice a day Day 93-96 - 12.5 mg every morning"
712243|NCT01780389|E1|Reported Event|Milnacipran|Open-label flexibly dosed milnacipran
712292|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712244|NCT01780350|B1|Baseline|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
712245|NCT01780350|P1|Participant Flow|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
712246|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
712247|NCT01780350|O1|Outcome|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
712248|NCT01780350|E1|Reported Event|ResQGARD ITD|"Subjects receive a ResQGARD ITD.~ResQGARD ITD: Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel."
712249|NCT01780337|B3|Baseline|Total|Total of all reporting groups
712250|NCT01780337|B2|Baseline|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
712251|NCT01780337|B1|Baseline|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
712252|NCT01780337|P2|Participant Flow|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
712253|NCT01780337|P1|Participant Flow|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
712254|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
712279|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712280|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712255|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
712256|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
712257|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
712258|NCT01780337|O2|Outcome|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
712664|NCT01777581|O1|Outcome|Milnacipran|Milnacipran, flexibly dosed (100-200 mg/day dosed twice a day)
712259|NCT01780337|O1|Outcome|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
712260|NCT01780337|E2|Reported Event|Saline|"Patients will be administered an intranasal dose of saline. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Saline: Intranasal dose of saline"
712261|NCT01780337|E1|Reported Event|Oxytocin|"Patients will be administered an intranasal dose of the study drug, 20 IU oxytocin. Repeat electrophysiologic measurements will be assessed at 15 minutes and 30 minutes after administration of the study medication/placebo. During the waiting periods in between the electrophysiologic measurements, we will continue with the standard protocol for an AF ablation, including transseptal puncture and left atrial mapping, performed prior to initiation of general anesthesia and actual delivery of ablation lesions. This 'preablation' period normally takes 45 minutes to one hour.~Oxytocin: Intranasal dose of 20 IU oxytocin"
712262|NCT01780324|B3|Baseline|Total|Total of all reporting groups
712263|NCT01780324|B2|Baseline|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
712264|NCT01780324|B1|Baseline|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
712265|NCT01780324|P2|Participant Flow|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
712266|NCT01780324|P1|Participant Flow|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
712267|NCT01780324|O2|Outcome|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
712268|NCT01780324|O1|Outcome|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
712269|NCT01780324|E2|Reported Event|Lidocaine|"This group will receive intraurethral lidocaine 5 minutes prior to urethral catheterization.~Lidocaine gel"
712270|NCT01780324|E1|Reported Event|No Lidocaine|This group will have urinary catheterization without lidocaine (per standard procedure)
712271|NCT01779648|B3|Baseline|Total|Total of all reporting groups
712272|NCT01779648|B2|Baseline|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712273|NCT01779648|B1|Baseline|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712274|NCT01779648|P2|Participant Flow|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~Alternate compression+Adjusted refill time"
712275|NCT01779648|P1|Participant Flow|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~Simultaneous compression +Fixed refill time:"
712276|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712277|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712278|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712281|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712282|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712283|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712284|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712285|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712286|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712287|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712288|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712289|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712290|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712291|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712665|NCT01777581|E2|Reported Event|Sugar Pill (Placebo)|Placebo
712293|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712294|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712295|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712296|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712297|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712298|NCT01779648|O2|Outcome|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712299|NCT01779648|O1|Outcome|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712300|NCT01779648|E2|Reported Event|Group AA|"alternate bilateral compression with adjusted venous refill time which would change several times during pneumatic compression~alternate compression :"
712301|NCT01779648|E1|Reported Event|Group SF|"Simultaneous bilateral compression with fixed venous refill time through the whole duration of pneumatic compression~simultaneous compression :"
712302|NCT01779219|B3|Baseline|Total|Total of all reporting groups
712303|NCT01779219|B2|Baseline|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
712304|NCT01779219|B1|Baseline|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with was used in all procedures."
712305|NCT01779219|P2|Participant Flow|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
712328|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712329|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712330|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712635|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712306|NCT01779219|P1|Participant Flow|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) was used in all cases."
712307|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
712308|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
712343|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712666|NCT01777581|E1|Reported Event|Milnacipran|Milnacipran, flexibly dosed
712309|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
712310|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
712311|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
712312|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
712313|NCT01779219|O2|Outcome|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
712331|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712314|NCT01779219|O1|Outcome|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
712315|NCT01779219|E2|Reported Event|Non-iMRI|"A frameless STx biopsy is performed for each patient from the control group with the use of a neuronavigation system. The entry point, target and optimal biopsy trajectory are defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).~Stereotactic frameless brain tumour biopsy: The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA)."
712316|NCT01779219|E1|Reported Event|iMRI|"The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet is used in all procedures. Subsequently, after the patient's positioning, the preoperative reference examination is routinely carried out (T1+gadolinum, T2 or FLAIR weighted - depending on the pathology, axial 4 mm scans). The entry point, target and optimal biopsy trajectory are then defined by the operator on the basis of the obtained iMRI images. Serial tissue samples (4 from the central and another 4 from the marginal part of the tumour) are collected. Following each operation, a control iMRI (T1-weighted, axial, 4 mm scan examination) is routinely performed to confirm and document the proper targeting and to exclude postoperative hyperacute intraparenchymal bleeding.~Stereotactic intraoperative magnetic resonance (iMRI)-guided frameless brain tumour biopsy: The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a was used in all procedures."
712344|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712345|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712667|NCT01777438|B3|Baseline|Total|Total of all reporting groups
712317|NCT01779167|B1|Baseline|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
712318|NCT01779167|P1|Participant Flow|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
712319|NCT01779167|O1|Outcome|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
712320|NCT01779167|O1|Outcome|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
712321|NCT01779167|E1|Reported Event|All Patients|"Daily alternating thalidomide and lenalidomide plus rituximab (ThRiL) in patients with previously treated WM~Thalidomide: Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)~Lenalidomide: Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.~Rituximab: Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc)."
712322|NCT01778985|B3|Baseline|Total|Total of all reporting groups
712323|NCT01778985|B2|Baseline|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712324|NCT01778985|B1|Baseline|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712325|NCT01778985|P2|Participant Flow|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712326|NCT01778985|P1|Participant Flow|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712327|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712371|NCT01778855|B1|Baseline|Normothermia|IV t-PA and normothermia
712332|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712333|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712334|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712335|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712336|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712337|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712338|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712339|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712340|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712341|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712342|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712402|NCT01778127|B4|Baseline|Total|Total of all reporting groups
712798|NCT01777217|P2|Participant Flow|Placebo|"Drug: Placebo oral~Placebo"
712346|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712347|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712348|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712349|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712350|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712351|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712352|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712353|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712354|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712355|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712356|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712357|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712358|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712359|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712360|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712361|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712362|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712363|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712364|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712365|NCT01778985|O2|Outcome|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712366|NCT01778985|O1|Outcome|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712367|NCT01778985|E2|Reported Event|Placebo|"Placebo cream, applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Placebo"
712368|NCT01778985|E1|Reported Event|Premarin|"Premarin cream 0.625mg/1gm. Applied to vagina by applicator as 1gm nightly for 2 weeks then 1gm 2 nights per week for 4-6 weeks or until day of surgery.~Premarin"
712369|NCT01778855|B3|Baseline|Total|Total of all reporting groups
712370|NCT01778855|B2|Baseline|Hypothermia|IV t-PA and hypothermia
712379|NCT01778751|B2|Baseline|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
712380|NCT01778751|B1|Baseline|Control|Veterans will receive diabetes educational materials and management per their primary provider
712403|NCT01778127|B3|Baseline|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712799|NCT01777217|P1|Participant Flow|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
712381|NCT01778751|P2|Participant Flow|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
712382|NCT01778751|P1|Participant Flow|Control|Veterans will receive diabetes educational materials and management per their primary provider
712383|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
712384|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
712385|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
712386|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
712387|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
712388|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
712389|NCT01778751|O2|Outcome|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
712390|NCT01778751|O1|Outcome|Control|Veterans will receive diabetes educational materials and management per their primary provider
712489|NCT01778023|P2|Participant Flow|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712391|NCT01778751|E2|Reported Event|Intervention|"Veterans randomized to the intervention arm will be enrolled in the HT program, provided with standard telemonitoring equipment by HT nursing staff (current HT practice at DVAMC is use of the Health Buddy 3 device for patients with landline phones and the Cardiocom Interactive Voice Response System for patients with cell phones), and will receive the study intervention for 6 months. Veterans without depressive symptoms on baseline PHQ-9 assessment (PHQ-9 < 10) will not initially be entered into the depressive symptom management component of the intervention, but will be monitored for new symptoms throughout the intervention.~Home Telehealth with Behavioral Education Component: The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms."
712392|NCT01778751|E1|Reported Event|Control|Veterans will receive diabetes educational materials and management per their primary provider
712393|NCT01778530|B1|Baseline|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
712394|NCT01778530|P1|Participant Flow|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
712395|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
712396|NCT01778530|O1|Outcome|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
712397|NCT01778530|E1|Reported Event|TRC105 for Recurrent Glioblastoma|TRC105: Intravenous infusion.
712398|NCT01778296|B1|Baseline|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
712399|NCT01778296|P1|Participant Flow|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
712400|NCT01778296|O1|Outcome|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
712401|NCT01778296|E1|Reported Event|Surgical Flap|The neurocutaneous island flap is based on the dorsal branch of the digital nerve
712404|NCT01778127|B2|Baseline|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712405|NCT01778127|B1|Baseline|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712406|NCT01778127|P3|Participant Flow|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712407|NCT01778127|P2|Participant Flow|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712408|NCT01778127|P1|Participant Flow|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712409|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712490|NCT01778023|P1|Participant Flow|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712491|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
716474|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
712410|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712411|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712412|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712461|NCT01778062|E2|Reported Event|Placebo|Placebo
712462|NCT01778062|E1|Reported Event|Indacaterol|Indacaterol
712463|NCT01778049|B3|Baseline|Total|Total of all reporting groups
712464|NCT01778049|B2|Baseline|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
712413|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712414|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712415|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712416|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712417|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712418|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712419|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712420|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712421|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712465|NCT01778049|B1|Baseline|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
712466|NCT01778049|P6|Participant Flow|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712422|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712423|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712424|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712425|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712426|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712427|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712428|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712429|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712430|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712467|NCT01778049|P5|Participant Flow|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
712468|NCT01778049|P4|Participant Flow|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712469|NCT01778049|P3|Participant Flow|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
712431|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712432|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712433|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712434|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712435|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712436|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712437|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712438|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712439|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712470|NCT01778049|P2|Participant Flow|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
712602|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712440|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712441|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712442|NCT01778127|O3|Outcome|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712443|NCT01778127|O2|Outcome|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712444|NCT01778127|O1|Outcome|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712445|NCT01778127|E3|Reported Event|Group C: Control|"Participants in the control group will receive an activity monitor and educational materials, but will not have access to the interactive website. No rewards will be offered for their participation.~Activity Monitor: Measurement of physical activity.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712446|NCT01778127|E2|Reported Event|Group B: Immediate Incentives|"Participants use an activity monitor and the interactive website.~In addition to minimal rewards, participants will receive immediate incentives as they move from one level to the other on the website.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712447|NCT01778127|E1|Reported Event|Group A: Minimal Rewards|"Participants use an activity monitor and the interactive website. They will receive minimal rewards based on their physical activity levels.~Activity Monitor: Measurement of physical activity.~Interactive Website: Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.~Educational Materials: All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance."
712448|NCT01778062|B3|Baseline|Total|Total of all reporting groups
712449|NCT01778062|B2|Baseline|Placebo|Placebo once daily
712450|NCT01778062|B1|Baseline|Indacaterol|Indacaterol 150 µg once daily
712451|NCT01778062|P2|Participant Flow|Placebo|Placebo once daily
712452|NCT01778062|P1|Participant Flow|Indacaterol|Indacaterol 150 µg once daily
712453|NCT01778062|O2|Outcome|Placebo|Placebo once daily
712454|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
712455|NCT01778062|O2|Outcome|Placebo|Placebo once daily
712456|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
712457|NCT01778062|O2|Outcome|Placebo|Placebo once daily
712458|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
712459|NCT01778062|O2|Outcome|Placebo|Placebo once daily
712460|NCT01778062|O1|Outcome|Indacaterol|Indacaterol 150 µg once daily
712471|NCT01778049|P1|Participant Flow|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
712472|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712473|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
712474|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712475|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
712476|NCT01778049|O4|Outcome|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712477|NCT01778049|O3|Outcome|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
712478|NCT01778049|O2|Outcome|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712479|NCT01778049|O1|Outcome|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
712480|NCT01778049|E6|Reported Event|Plc (E25)|Subjects were orally administered empa 25 mg and matching placebo to FDC empa 25 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712481|NCT01778049|E5|Reported Event|Lina5 (E25)|Subjects were orally administered FDC empa 25 mg/lina 5 mg and placebo matching to empa 25 mg for 24 wk during the double-blind treatment period.
712482|NCT01778049|E4|Reported Event|Plc (E10)|Subjects were orally administered empa 10 mg and matching placebo to FDC empa 10 mg/lina 5 mg for 24 wk during the double-blind treatment period.
712483|NCT01778049|E3|Reported Event|Lina5 (E10)|Subjects were orally administered FDC empa 10 mg/lina 5 mg and placebo matching to empa 10 mg for 24 wk during the double-blind treatment period.
712484|NCT01778049|E2|Reported Event|Empa 25 mg OL|Subjects were orally administered once daily empa 25 mg film-coated tablet for 16 week during OL treatment period, thereafter patients received once daily FDC Plc tablet matching to FDC empa 25 mg/lina 5 mg in addition to empa 25 mg for 1 wk during open label placebo add-on treatment period.
712485|NCT01778049|E1|Reported Event|Empa 10 mg OL|Subjects were orally administered once daily empa 10 mg film-coated tablet for 16 wk during OL treatment period, thereafter patients received once daily fixed dose combination (FDC) placebo tablet matching to FDC empa 10 mg/lina 5 mg in addition to empa 10 mg for 1 week during open label placebo add-on treatment period.
712486|NCT01778023|B3|Baseline|Total|Total of all reporting groups
712487|NCT01778023|B2|Baseline|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712488|NCT01778023|B1|Baseline|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712626|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712627|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712492|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712493|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712494|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712495|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712496|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712497|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712603|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712498|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712499|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712500|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712501|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712502|NCT01778023|O2|Outcome|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712503|NCT01778023|O1|Outcome|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712504|NCT01778023|E2|Reported Event|Group B: 6-month Untreated + 6-month GH Treatment|Subjects participated in the trial for 12 months. For the first six months of the trial period, subjects were untreated. For the last six months of the trial period, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712505|NCT01778023|E1|Reported Event|Group A: 12-month GH Treatment|For 12 months, a weekly dosage of 0.469 mg of somatropin (hGH) per kg of body weight was injected subcutaneously in the evening in seven (7) days per week using the Norditropin® Nordilet®.
712506|NCT01777945|B1|Baseline|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712507|NCT01777945|P1|Participant Flow|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712508|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712509|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712510|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712511|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712512|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712513|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712514|NCT01777945|O1|Outcome|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712515|NCT01777945|E1|Reported Event|Participants Receiving Capecitabine/Docetaxel|Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
712516|NCT01777932|B1|Baseline|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712628|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712517|NCT01777932|P1|Participant Flow|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712518|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712519|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712520|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712521|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712600|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712648|NCT01777581|B1|Baseline|Milnacipran|Milnacipran, flexibly dosed 100-200 mg/day dosed twice a day
712522|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712523|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712524|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712525|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712526|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712527|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712528|NCT01777932|O1|Outcome|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712529|NCT01777932|E1|Reported Event|Paclitaxel + Bevacizumab Arm|Participants received licensed dose regimens of bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until disease progression, or unacceptable toxicity (whichever occurred first), in accordance with the summary of product characteristics. Paclitaxel could be administered weekly or every 3 weeks according to the accepted oncology protocol.
712530|NCT01777776|B5|Baseline|Total|Total of all reporting groups
712531|NCT01777776|B4|Baseline|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712532|NCT01777776|B3|Baseline|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712533|NCT01777776|B2|Baseline|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712629|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712630|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
716475|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
712534|NCT01777776|B1|Baseline|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712535|NCT01777776|P4|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712536|NCT01777776|P3|Participant Flow|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712537|NCT01777776|P2|Participant Flow|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712538|NCT01777776|P1|Participant Flow|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712539|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712601|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712649|NCT01777581|P2|Participant Flow|Sugar Pill (Placebo)|Placebo
712540|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712541|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712542|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712543|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712544|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712545|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712546|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712547|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712548|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712549|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712550|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712551|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712631|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712632|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712552|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712553|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712554|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712555|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712556|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712557|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712558|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712559|NCT01777776|O3|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712560|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712561|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712562|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712563|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712564|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712565|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712566|NCT01777776|O2|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712567|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712568|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712569|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712570|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712571|NCT01777776|O4|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712572|NCT01777776|O3|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712573|NCT01777776|O2|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712574|NCT01777776|O1|Outcome|Phase I (Dose Escalation)|"Adult patients with locally advanced or metastatic BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment or patients who are naïve to selective BRAFi treatment.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712575|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712576|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712577|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712578|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712579|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712580|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712581|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712582|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712583|NCT01777776|O1|Outcome|Phase II - Arm 2 (BRAFi Resistant)|Patients with BRAF V600 mutant melanoma who are resistant to selective BRAFi treatment will be enrolled into LEE011+ LGX818.
712584|NCT01777776|O2|Outcome|Phase II - Arm 1b (LGX818)|"Patients administered LGX818. Single agent anti-tumor activity of LGX818 is comparable to other BRAFi that are either approved or in clinical trials. This single agent anti-tumor activity will be compared to that of the combination (LEE011 + LGX818) in the BRAFi naïve patient population.~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712585|NCT01777776|O1|Outcome|Phase II - Arm 1a (LGX818+LEE011)|"Patients naïve to prior BRAF inhibitor therapy were administered LGX818+LEE011 to evaluate the effect of adding LEE011 to a BRAFi in this population.~LEE011: Administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).~LGX818: Administered orally, once daily on a continuous dosing schedule (28-day cycle)."
712586|NCT01777776|O4|Outcome|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712587|NCT01777776|O3|Outcome|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712588|NCT01777776|O2|Outcome|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712633|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712634|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712589|NCT01777776|O1|Outcome|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712590|NCT01777776|E4|Reported Event|Phase Ib: LEE011 400 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712591|NCT01777776|E3|Reported Event|Phase Ib: LEE011 400 mg + LGX818 100 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712592|NCT01777776|E2|Reported Event|Phase Ib: LEE011 300 mg + LGX818 200 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712593|NCT01777776|E1|Reported Event|Phase Ib: LEE011 200 mg + LGX818 300 mg (Cohort)|"Ribociclib (LEE011) was provided in capsule form for oral use and was to be taken orally, once a day for 21 consecutive days followed by a 7-day planned break as part of each 28-day cycle of treatment.~Encorafenib (LGX818) was to be provided in capsule form for oral use and taken orally, once a day for 28 consecutive days as part of each 28-day cycle of treatment."
712594|NCT01777763|B3|Baseline|Total|Total of all reporting groups
712595|NCT01777763|B2|Baseline|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days.
712596|NCT01777763|B1|Baseline|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days.
712597|NCT01777763|P2|Participant Flow|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712598|NCT01777763|P1|Participant Flow|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712599|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712650|NCT01777581|P1|Participant Flow|Milnacipran|Milnacipran, flexibly dosed
712604|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712605|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712606|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712607|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712608|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712609|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712610|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712611|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712612|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712613|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712614|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712615|NCT01777763|O2|Outcome|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712616|NCT01777763|O1|Outcome|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712617|NCT01777763|E2|Reported Event|Posaconazole 300 mg|Posaconazole 300 mg (three 100 mg tablets) BID on Day 1 followed by 300 mg (three 100 mg tablets) QD for up to 28 days
712618|NCT01777763|E1|Reported Event|Posaconazole 200 mg|Posaconazole 200 mg (two 100 mg tablets) twice daily (BID) on Day 1 followed by 200 mg (two 100 mg tablets) once daily (QD) for up to 28 days
712619|NCT01777620|B3|Baseline|Total|Total of all reporting groups
712620|NCT01777620|B2|Baseline|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712621|NCT01777620|B1|Baseline|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712622|NCT01777620|P2|Participant Flow|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712623|NCT01777620|P1|Participant Flow|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712624|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712625|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712636|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712637|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712638|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712639|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712640|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712641|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712642|NCT01777620|O2|Outcome|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712643|NCT01777620|O1|Outcome|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712644|NCT01777620|E2|Reported Event|Placebo|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
712645|NCT01777620|E1|Reported Event|BOTOX®|BOTOX® (onabotulinumtoxinA) 44U total dose injected into the areas of glabellar lines and crow's feet lines on Day 1.
712646|NCT01777581|B3|Baseline|Total|Total of all reporting groups
712647|NCT01777581|B2|Baseline|Sugar Pill (Placebo)|Placebo
712668|NCT01777438|B2|Baseline|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
712669|NCT01777438|B1|Baseline|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
712670|NCT01777438|P2|Participant Flow|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
712671|NCT01777438|P1|Participant Flow|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
712672|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
712673|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
712674|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
712675|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
712676|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
712677|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
712678|NCT01777438|O2|Outcome|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
712679|NCT01777438|O1|Outcome|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
712680|NCT01777438|E2|Reported Event|Patients Having SCIT|patients who started immunotherapy at the Department of Allergology of the University Hospitals Leuven between November 2007 and February 2010.
712681|NCT01777438|E1|Reported Event|Control Group|a control group of AR patients who visited the ENT department of the University Hospitals Leuven in the same time period
712682|NCT01777425|B1|Baseline|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
712683|NCT01777425|P1|Participant Flow|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
712684|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
712685|NCT01777425|O1|Outcome|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
712686|NCT01777425|O1|Outcome|Rhinosinusitis Patients and Status|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
712687|NCT01777425|E1|Reported Event|Rhinosinusitis Patients|patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
712688|NCT01777412|B1|Baseline|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
712689|NCT01777412|P1|Participant Flow|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
712690|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
712691|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
712692|NCT01777412|O1|Outcome|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
712737|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712693|NCT01777412|E1|Reported Event|Bevacizumab|Bevacizumab 10 mg/kg intravenous infusion at onset of exacerbation and, if needed, a second time during the plasma exchange phase in additional 5 days of 1000 mg methylprednisolone infusion. There was no placebo or comparator group.
712694|NCT01777334|B3|Baseline|Total|Total of all reporting groups
712695|NCT01777334|B2|Baseline|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
712696|NCT01777334|B1|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
712697|NCT01777334|P2|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
712698|NCT01777334|P1|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
712699|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
712700|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
712701|NCT01777334|O2|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
712800|NCT01777217|O2|Outcome|Placebo|"Drug: Placebo oral~Placebo"
712702|NCT01777334|O1|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
712703|NCT01777334|E2|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD each morning via a DPI and placebo QD each morning via a DPI for 24 weeks.
712704|NCT01777334|E1|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 micrograms (µg) once daily (QD) each morning via a dry powder inhaler (DPI) and placebo QD each morning via a DPI for 24 weeks.
712705|NCT01777321|B3|Baseline|Total|Total of all reporting groups
712706|NCT01777321|B2|Baseline|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712707|NCT01777321|B1|Baseline|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712708|NCT01777321|P2|Participant Flow|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered intramuscularly (IM) on a 0,2-month schedule.
712709|NCT01777321|P1|Participant Flow|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered subcutaneously (SC) on a 0,2-month schedule.
712710|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712711|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712712|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712713|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712714|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712715|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712716|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712717|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712718|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712719|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712720|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712721|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712722|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712723|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712724|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712725|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712726|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712727|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712728|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712729|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712730|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712731|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712732|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712733|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712734|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712735|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712736|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712738|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712739|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712740|NCT01777321|O2|Outcome|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712741|NCT01777321|O1|Outcome|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712742|NCT01777321|E2|Reported Event|IM GSK1437173A Group|Subjects received the GSK1437173A vaccine administered IM on a 0,2-month schedule.
712743|NCT01777321|E1|Reported Event|SC GSK1437173A Group|Subjects received the GSK1437173A vaccine administered SC on a 0,2-month schedule.
712744|NCT01777282|B6|Baseline|Total|Total of all reporting groups
712745|NCT01777282|B5|Baseline|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712746|NCT01777282|B4|Baseline|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712801|NCT01777217|O1|Outcome|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
712747|NCT01777282|B3|Baseline|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712748|NCT01777282|B2|Baseline|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712749|NCT01777282|B1|Baseline|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712750|NCT01777282|P5|Participant Flow|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712751|NCT01777282|P4|Participant Flow|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712752|NCT01777282|P3|Participant Flow|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712753|NCT01777282|P2|Participant Flow|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712754|NCT01777282|P1|Participant Flow|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712755|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712756|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712757|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712758|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712759|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712760|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712761|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712762|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712763|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712764|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712765|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712766|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712767|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712768|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712769|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712770|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712802|NCT01777217|E2|Reported Event|Placebo|"Drug: Placebo oral~Placebo"
712803|NCT01777217|E1|Reported Event|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
712771|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712772|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712773|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712774|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712775|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712776|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712777|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712778|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712779|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712780|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712781|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712782|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712783|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712784|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712785|NCT01777282|O5|Outcome|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712786|NCT01777282|O4|Outcome|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712787|NCT01777282|O3|Outcome|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712788|NCT01777282|O2|Outcome|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712789|NCT01777282|O1|Outcome|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712790|NCT01777282|E5|Reported Event|Albiglutide Plus (+) Background OAD (α-Glucosidase Inhibitor)|Participants received current regimen of 30 mg albiglutide + α-glucosidase inhibitor as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712791|NCT01777282|E4|Reported Event|Albiglutide Plus (+) Background OAD (Thiazolidinedione)|Participants received current regimen of 30 mg albiglutide + thiazolidinedione as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712792|NCT01777282|E3|Reported Event|Albiglutide Plus (+) Background OAD (Glinide)|Participants received current regimen of 30 mg albiglutide + glinide as a subcutaneous injection weekly (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712793|NCT01777282|E2|Reported Event|Albiglutide Plus (+) Background OAD (Biguanide)|Participants received current regimen of 30 mg albiglutide + biguanide (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712794|NCT01777282|E1|Reported Event|Albiglutide Plus (+) Background OAD (Sulfonylurea)|Participants received current regimen of 30 milligrams (mg) albiglutide + sulfonylurea (with titration to 50 mg at Week 4 or later based on specific guidelines on glycemic control) through Week 52.
712795|NCT01777217|B3|Baseline|Total|Total of all reporting groups
712796|NCT01777217|B2|Baseline|Placebo|"Drug: Placebo oral~Placebo"
712797|NCT01777217|B1|Baseline|Solifenacin Succinate|"Solifenacin succinate, 5mg or 10 mg once daily~Solifenacin succinate"
712805|NCT01777191|B2|Baseline|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712806|NCT01777191|B1|Baseline|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712807|NCT01777191|P2|Participant Flow|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712808|NCT01777191|P1|Participant Flow|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (Q2W) at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose every 4 weeks (Q4W).
712809|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712810|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712811|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712812|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712813|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712814|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712815|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712816|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712817|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712818|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712819|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712820|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
716476|NCT01761279|O2|Outcome|i-Scan|High definition white light endoscopy with i-Scan image enhancement
712821|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712822|NCT01777191|O1|Outcome|80 mg Ixekizumab|Ixekizumab administered via prefilled syringe and auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712823|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712824|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712825|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712893|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712826|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712827|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712828|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712829|NCT01777191|O2|Outcome|80 mg Ixekizumab Auto-Injector|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712830|NCT01777191|O1|Outcome|80 mg Ixekizumab Prefilled Syringe|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712831|NCT01777191|E4|Reported Event|Follow Up Period|All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
712832|NCT01777191|E3|Reported Event|80 mg Ixe Prefilled Syringe Optional Safety Extension|One 80 mg Ixekizumab administered as an SC injection Q4W.
712833|NCT01777191|E2|Reported Event|80 mg Ixekizumab Auto-Injector Treatment Period|Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712834|NCT01777191|E1|Reported Event|80 mg Ixekizumab Prefilled Syringe Treatment Period|Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W.
712835|NCT01777126|B3|Baseline|Total|Total of all reporting groups
712836|NCT01777126|B2|Baseline|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712837|NCT01777126|B1|Baseline|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712838|NCT01777126|P2|Participant Flow|Oral Nutrition Protocol (ONP) Group|In this group, oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712839|NCT01777126|P1|Participant Flow|Control Group|In the control group, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712840|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712894|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712841|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712842|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712843|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712844|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712845|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712846|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712882|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712847|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712848|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712895|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712896|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712849|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712850|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712851|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712852|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712853|NCT01777126|O1|Outcome|Control Group|Subjects enrolled in this arm will undergo the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712854|NCT01777126|O1|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712855|NCT01777126|O2|Outcome|Oral Nutrition Protocol (ONP) Group|Subjects enrolled in this arm will undergo the ONP protocol. Oral intake was increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used were Fortimel Juicy®, 200 ml containing 300 kcal (total energy). A detailed description of the content of Fortimel Jucy® is available on www.nutriciamedical.be. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician. If the patient was unable to produce stools on the third day post-surgery, neostigmine (Prostigmine® 0.5 mg subcutaneous, maximum four times a day), promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel [14], could be administered. Only if oral intake was still insufficient after five days, as defined by the opinion of the treating physician, PN could be initiated in this group.
712856|NCT01777126|O1|Outcome|Control Group|For subjects enrolled in this arm, PN was part of the routine postoperative care pathway. PN was initiated the day postoperatively and was continued until the patients were able to tolerate solid food. PN consisted of Olimel® N7E 1000, 1500 ml or 2000 ml, a parenteral solution with a non-protein energy of 960 kcal/1000ml and containing polyamino-acids (43.75g/1000 ml), glucose (140g/1000ml), lipids (40g/1000ml) and electrolytes. The amount of PN administered depended on non-protein requirement, calculated by 25 kcal/kg ideal body weight ± 10%. Cernevit®, a multivitamin powder for injection, and Addamel®, a trace elements containing concentrate for injection, were added to the PN daily. Supplementary fluids, up to two liter per day, was given intravenously, if deemed necessary by the treating physician.
712897|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712898|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712857|NCT01777126|E2|Reported Event|Enhanced Recovery Oral Nutrition Protocol (ERONP) Group|Subjects enrolled in this arm will undergo the ERONP protocol. An enhanced oral nutrition protocol (ERONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Juicy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. If the patient is unable to produce stools on the third day post-surgery, neostigmine (Prostigmin® 0.5 mg subcutaneous, maximum 4 times a day), an acetylcholinesterase inhibitor promoting the movement of intestinal contents by augmenting motor activity of the small and large bowel, can be administered. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.
712858|NCT01777126|E1|Reported Event|Control Group|Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
712859|NCT01776645|B3|Baseline|Total|Total of all reporting groups
712860|NCT01776645|B2|Baseline|Significant Others Group|Significant Others of Participants with Chronic Pain
712861|NCT01776645|B1|Baseline|Compassion Cultivation Training - Participants With Chronic Pa|Compassion Cultivation Training Course - Participants with Chronic Pain
712862|NCT01776645|P2|Participant Flow|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
712863|NCT01776645|P1|Participant Flow|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
712864|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
712865|NCT01776645|O1|Outcome|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
712866|NCT01776645|E2|Reported Event|Significant Others Group|Significant others of the individuals with chronic pain undergoing the compassion cultivation training course
712867|NCT01776645|E1|Reported Event|Compassion Cultivation Training|Compassion Cultivation Training Course - Participants with Chronic Pain
712868|NCT01776554|B3|Baseline|Total|Total of all reporting groups
712869|NCT01776554|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712870|NCT01776554|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712871|NCT01776554|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712872|NCT01776554|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712873|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712874|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712875|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712876|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712877|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712878|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712879|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712880|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712881|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712883|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712884|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712885|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712886|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712887|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712888|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712889|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712890|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712891|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712892|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712899|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712900|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712901|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712902|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712903|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712904|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712905|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712906|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712907|NCT01776554|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712908|NCT01776554|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712909|NCT01776554|E3|Reported Event|Total|Total of subjects in both high dose and low dose groups.
712910|NCT01776554|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712911|NCT01776554|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712912|NCT01776541|B3|Baseline|Total|Total of all reporting groups
712913|NCT01776541|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712914|NCT01776541|B1|Baseline|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712915|NCT01776541|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712916|NCT01776541|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712917|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712918|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712919|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712920|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712921|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712922|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712923|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712924|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712925|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712926|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712927|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
713280|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
712928|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712929|NCT01776541|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712930|NCT01776541|O1|Outcome|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
712931|NCT01776541|E3|Reported Event|Total|Total of high dose and low dose groups.
712932|NCT01776541|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712933|NCT01776541|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
712934|NCT01775995|B3|Baseline|Total|Total of all reporting groups
712935|NCT01775995|B2|Baseline|Wait-list Control|Standard of Care Therapy only
712936|NCT01775995|B1|Baseline|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
712937|NCT01775995|P2|Participant Flow|Wait-list Control|"Usual Care~Participants receiving usual care for CLBP and opioid therapy management."
712938|NCT01775995|P1|Participant Flow|Meditation-CBT|"Meditation-CBT + Usual Care~Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management."
712939|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712940|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712941|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712942|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712943|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712944|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712945|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712946|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712947|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712948|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712949|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712950|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712951|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712952|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712953|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712954|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712955|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712956|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712957|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712958|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712959|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712960|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712961|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712962|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712963|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712964|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712965|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712966|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712967|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
713281|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
712968|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712969|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712970|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712971|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712972|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712973|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712974|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712975|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712976|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712977|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712978|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712979|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
713298|NCT01773291|B1|Baseline|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
712980|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712981|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712982|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712983|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712984|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712985|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712986|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712987|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712988|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712989|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712990|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712991|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712992|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712993|NCT01775995|O2|Outcome|Wait-list Control|Usual Care Participants receiving usual care for CLBP and opioid therapy management.
712994|NCT01775995|O1|Outcome|Meditation-CBT|Meditation-CBT + Usual Care Participants receiving the meditation-CBT intervention, in addition to usual care for CLBP and opioid therapy management.
712995|NCT01775995|E2|Reported Event|Wait-list Control|Standard of Care Therapy only
712996|NCT01775995|E1|Reported Event|Experimental: Meditation-CBT|"Mindfulness-CBT + Standard of Care Therapy~Mindfulness Based Intervention with Cognitive Behavioral Therapy (CBT) components: All study subjects receive standard of care therapy. In addition, experimental subjects receive the mindfulness-CBT. The intervention consists of an 8-week meditation-CBT course (2 hour weekly group sessions) and daily, at-home practice (30 mins/day, 6 days/week of formal practice). Controls will be offered meditation intervention after completing the study."
712997|NCT01775852|B3|Baseline|Total|Total of all reporting groups
712998|NCT01775852|B2|Baseline|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
712999|NCT01775852|B1|Baseline|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
713000|NCT01775852|P2|Participant Flow|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
713016|NCT01775670|P1|Participant Flow|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for trapeziometacarpal (TMC) arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713001|NCT01775852|P1|Participant Flow|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
713002|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
713003|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
713004|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
713028|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713029|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713005|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
713006|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
713007|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
713008|NCT01775852|O2|Outcome|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
713009|NCT01775852|O1|Outcome|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
713010|NCT01775852|E2|Reported Event|Waitlist/Treatment as Usual|The Waitlist/Treatment as Usual (WL/TAU)condition completes the same assessments as the active treatment group but does not undergo the active treatment (workshop) until after the 12-week follow-up visit. At that point, the WL/TAU participants are given the opportunity to join a treatment workshop.
713011|NCT01775852|E1|Reported Event|ACT-IM|"The ACT-IM arm is a brief, one-day intervention that includes two components: 1) Illness Management for Migraine and, 2) Acceptance and Commitment Therapy for emotional difficulties that go along with, or are exacerbated by migraine.~ACT-IM: 1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations."
713012|NCT01775670|B3|Baseline|Total|Total of all reporting groups
713013|NCT01775670|B2|Baseline|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713014|NCT01775670|B1|Baseline|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713015|NCT01775670|P2|Participant Flow|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the Massachusetts General Hospital (MGH) Occupational Therapists.~Occupational Therapy (OT) Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713282|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713017|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713018|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713019|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713020|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713021|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713022|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713023|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713024|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713025|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713026|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713027|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713030|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713031|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713032|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713033|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713034|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713035|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713036|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713037|NCT01775670|O2|Outcome|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713038|NCT01775670|O1|Outcome|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713039|NCT01775670|E2|Reported Event|OT Splint|"Subjects in this arm will be managed with a custom-made splint made by the MGH Occupational Therapists.~OT Splint: Subjects will use a splint custom-made by MGH Occupational Therapists."
713040|NCT01775670|E1|Reported Event|Off-the-Shelf Splint|"Subjects in this arm will be managed with off-the-shelf splints for TMC arthrosis.~Off-the-shelf splint: Subjects will use an off-the-shelf splint"
713041|NCT01775137|B1|Baseline|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713042|NCT01775137|P1|Participant Flow|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713043|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713044|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713045|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713046|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713047|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713048|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713049|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713050|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713051|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713052|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713053|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713054|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713055|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713056|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713057|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713058|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713059|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713060|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) twice daily (bid) via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713283|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713061|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713062|NCT01775137|O1|Outcome|Tobramycin Inhalation Powder|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid).The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713063|NCT01775137|E3|Reported Event|Overall|All participants who inhaled tobramycin inhalation powder during both core and extension study.
713064|NCT01775137|E2|Reported Event|Extension|Participants inhaled four capsules of tobramycin inhalation powder (28 mg) bid via the T-326 inhaler device, for 28 days (treatment phase in each cycle). Each treatment phase therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose of 224 mg tobramycin (112 mg bid). The treatment phase was followed by 28 days of no study treatment (off treatment in each cycle). These 56 days represented 1 cycle of therapy.
713065|NCT01775137|E1|Reported Event|Core|Eligible participants were assigned to four capsules of TIP at 28 mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112 mg tobramycin (4 capsules of 28 mg each) with the total daily dose = 224 mg tobramycin (112 mg b.i.d.). These 56 days represented 1 cycle of therapy during core study.
713066|NCT01774968|B3|Baseline|Total|Total of all reporting groups
713067|NCT01774968|B2|Baseline|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713068|NCT01774968|B1|Baseline|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713069|NCT01774968|P2|Participant Flow|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, two times a day (BID) for 24 weeks.
713070|NCT01774968|P1|Participant Flow|Human Regular U-500 Insulin TID|Human Regular U-500 Insulin (U-500R) titrated based on blood glucose readings, administered subcutaneously (SC), three times a day (TID) for 24 weeks.
713071|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713072|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713073|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713074|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713075|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713076|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713077|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713078|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713079|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713080|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713081|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713082|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713083|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713084|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713085|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713086|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713087|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713088|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713089|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713090|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713091|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713092|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713093|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713094|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713095|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713096|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713097|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
716477|NCT01761279|O1|Outcome|HDWL|High Definition White Light Endoscopy
713098|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713099|NCT01774968|O2|Outcome|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713100|NCT01774968|O1|Outcome|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713101|NCT01774968|E2|Reported Event|Human Regular U-500 Insulin BID|U-500R Insulin titrated based on blood glucose readings, administered SC, BID for 24 weeks.
713102|NCT01774968|E1|Reported Event|Human Regular U-500 Insulin TID|U-500R Insulin titrated based on blood glucose readings, administered SC, TID for 24 weeks.
713103|NCT01774929|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
713104|NCT01774929|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
713105|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
713106|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
713107|NCT01774929|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
713108|NCT01774929|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
713109|NCT01774903|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
713155|NCT01774305|B2|Baseline|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
713110|NCT01774903|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
713111|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
713112|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
713113|NCT01774903|O1|Outcome|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
713114|NCT01774903|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
713115|NCT01774903|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram (mcg) per hour for 3 days. The patches were replaced every 3 days until 30 days.
713116|NCT01774604|B3|Baseline|Total|Total of all reporting groups
713117|NCT01774604|B2|Baseline|Placebo|"Placebo suppositories (#2)~Placebo"
713118|NCT01774604|B1|Baseline|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713119|NCT01774604|P2|Participant Flow|Placebo|"Placebo suppositories (#2)~Placebo"
713120|NCT01774604|P1|Participant Flow|Indomethacin|"Indomethacin 100 mg Per Rectum (PR) x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713121|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
713122|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713123|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
713124|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713125|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
713126|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713127|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
713128|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713129|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
713130|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713131|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
713132|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713133|NCT01774604|O2|Outcome|Placebo|"Placebo suppositories (#2)~Placebo"
713134|NCT01774604|O1|Outcome|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713135|NCT01774604|E2|Reported Event|Placebo|"Placebo suppositories (#2)~Placebo"
713136|NCT01774604|E1|Reported Event|Indomethacin|"Indomethacin 100 mg PR x 1 in peri-procedural period~Indomethacin: 100 mg Indomethacin PR x 1"
713137|NCT01774344|B3|Baseline|Total|Total of all reporting groups
713138|NCT01774344|B2|Baseline|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713139|NCT01774344|B1|Baseline|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
713140|NCT01774344|P2|Participant Flow|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713141|NCT01774344|P1|Participant Flow|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
713142|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713143|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
713144|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713145|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
713146|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713147|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
713148|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713149|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
713150|NCT01774344|O2|Outcome|Regorafenib 160 mg (BAY73-4506)|Subjects received regorafenib 160 milligram (mg) (4 * 40 mg coated tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713151|NCT01774344|O1|Outcome|Placebo|Subjects received placebo matched to regorafenib coated tablets orally every day for 3 weeks followed by 1 week off treatment plus best best supportive care.
713152|NCT01774344|E2|Reported Event|Regorafenib 160mg (BAY73-4506)|Subjects received regorafenib 160 mg (4 *40 mg tablets) orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713153|NCT01774344|E1|Reported Event|Placebo|Subjects received placebo matched to regorafenib tablets orally every day for 3 weeks followed by 1 week off treatment plus BSC.
713154|NCT01774305|B3|Baseline|Total|Total of all reporting groups
713156|NCT01774305|B1|Baseline|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
713157|NCT01774305|P2|Participant Flow|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
713158|NCT01774305|P1|Participant Flow|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
713159|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
713160|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
713161|NCT01774305|O2|Outcome|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
713162|NCT01774305|O1|Outcome|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
713163|NCT01774305|E2|Reported Event|Saline|We administrate the saline single bolus (0.25ml/kg,intravenously, for 10 min) at time of muscle layer closing.
713164|NCT01774305|E1|Reported Event|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously, for 10 min) at time of muscle layer closing.
713165|NCT01774253|B1|Baseline|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713166|NCT01774253|P1|Participant Flow|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713167|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713168|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713169|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713170|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713171|NCT01774253|O1|Outcome|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713172|NCT01774253|E1|Reported Event|Vismodegib|"Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.~Vismodegib"
713173|NCT01774149|B3|Baseline|Total|Total of all reporting groups
713174|NCT01774149|B2|Baseline|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713175|NCT01774149|B1|Baseline|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713206|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713176|NCT01774149|P2|Participant Flow|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713177|NCT01774149|P1|Participant Flow|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713178|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713179|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713180|NCT01774149|O2|Outcome|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713181|NCT01774149|O1|Outcome|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713182|NCT01774149|E2|Reported Event|Diastat|"Few Touch Application with Diastat module turned on in week 4 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
713183|NCT01774149|E1|Reported Event|Delayed Diastat|"Mobile phone application Few Touch Application (FTA) in the regular version, with Diastat turned on in week 12 post-enrollment.~Few Touch Application: Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.~Diastat: Users get the Few Touch Application with Diastat module activated."
715063|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
713184|NCT01774110|B1|Baseline|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
713185|NCT01774110|P1|Participant Flow|Early Standardized Task Training|"Persons in the experimental group will receive ESTT (early standardized task specific training) for gait treatment after stroke.~Early standardized task training: Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset."
713186|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
713187|NCT01774110|O1|Outcome|Early Standardized Treadmill Training|
713188|NCT01774110|O1|Outcome|ESTT|
713189|NCT01774110|E1|Reported Event|ESTT|early standardized treadmill training
713190|NCT01774097|B3|Baseline|Total|Total of all reporting groups
713191|NCT01774097|B2|Baseline|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713192|NCT01774097|B1|Baseline|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713193|NCT01774097|P2|Participant Flow|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713194|NCT01774097|P1|Participant Flow|ALDHbr|"Participants will receive ALDHbr via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
713195|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713196|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713197|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713198|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713199|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713200|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713201|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713202|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713203|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713204|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713205|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713279|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713207|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713208|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713209|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713210|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713211|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713212|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713213|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713214|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr in the index calf and posterior, lower thigh"
713215|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713216|NCT01774097|O1|Outcome|ALDHbr|Participants will receive ALDHbr cells via intramuscular injection ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh
713217|NCT01774097|O2|Outcome|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713218|NCT01774097|O1|Outcome|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713251|NCT01773122|B3|Baseline|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713219|NCT01774097|E2|Reported Event|Placebo (Vehicle)|"Participants will receive placebo (vehicle) via intramuscular injection~Placebo (vehicle): Ten 1ml injections of placebo in the index calf and posterior, lower thigh"
713220|NCT01774097|E1|Reported Event|ALDHbr|"Participants will receive ALDHbr cells via intramuscular injection~ALDHbr: Ten 1ml injections of ALDHbr cells in the index calf and posterior, lower thigh"
713221|NCT01774084|B3|Baseline|Total|Total of all reporting groups
713222|NCT01774084|B2|Baseline|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713223|NCT01774084|B1|Baseline|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713224|NCT01774084|P2|Participant Flow|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713225|NCT01774084|P1|Participant Flow|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713226|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713227|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713228|NCT01774084|O2|Outcome|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713229|NCT01774084|O1|Outcome|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713230|NCT01774084|E2|Reported Event|Water|Water: One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713231|NCT01774084|E1|Reported Event|PreOp, NutriciaNordica AB|PreOp: 50 kcal/100 mL in the form of maltodextrin and fructose. One bottle of 800 ml to be ingested at bedtime, and at midnight by the latest, and another bottle with 400 ml approximately 2 hours before surgery started.
713232|NCT01774045|B3|Baseline|Total|Total of all reporting groups
713233|NCT01774045|B2|Baseline|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
713234|NCT01774045|B1|Baseline|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
713235|NCT01774045|P2|Participant Flow|Placebo Control|"Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~Placebo"
713236|NCT01774045|P1|Participant Flow|PDC-1421|"Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observing for three Days.~PDC-1421"
713237|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
713238|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
713239|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
713240|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
713241|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
713242|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
713243|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and and observation from baseline to the following 72 hours
713244|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
713245|NCT01774045|O2|Outcome|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours.
713246|NCT01774045|O1|Outcome|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
713247|NCT01774045|E2|Reported Event|Placebo Control|Dosage form: Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
713248|NCT01774045|E1|Reported Event|PDC-1421|Dosage form: 380mg PDC-1421 per Capsule. Dosage: single dose (1, 3, 6, 10 capsule(s)). Frequency: once daily, p.o., after meal. Duration: single dose at Day 1, and observation from baseline to the following 72 hours
713249|NCT01773122|B5|Baseline|Total|Total of all reporting groups
713250|NCT01773122|B4|Baseline|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
713252|NCT01773122|B2|Baseline|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713253|NCT01773122|B1|Baseline|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713254|NCT01773122|P4|Participant Flow|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
713255|NCT01773122|P3|Participant Flow|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713256|NCT01773122|P2|Participant Flow|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713257|NCT01773122|P1|Participant Flow|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713258|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
713259|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713260|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713261|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713262|NCT01773122|O4|Outcome|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
713263|NCT01773122|O3|Outcome|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713264|NCT01773122|O2|Outcome|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713265|NCT01773122|O1|Outcome|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713266|NCT01773122|E4|Reported Event|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
713267|NCT01773122|E3|Reported Event|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713268|NCT01773122|E2|Reported Event|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713269|NCT01773122|E1|Reported Event|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
713270|NCT01773889|B1|Baseline|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
713271|NCT01773889|P1|Participant Flow|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
713272|NCT01773889|O1|Outcome|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
713273|NCT01773889|E1|Reported Event|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2A|Denileukin Diftitox Plus Subcutaneous Pegylated IFNα-2a :
713274|NCT01773473|B3|Baseline|Total|Total of all reporting groups
713275|NCT01773473|B2|Baseline|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713276|NCT01773473|B1|Baseline|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713277|NCT01773473|P2|Participant Flow|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713278|NCT01773473|P1|Participant Flow|Insulin Lispro Mix25|Insulin Lispro Mix25 administered subcutaneously (SC) using prefilled pen twice daily for 26 weeks.
716556|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
713284|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713285|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713286|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713287|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713288|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713289|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713290|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713291|NCT01773473|O2|Outcome|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713292|NCT01773473|O1|Outcome|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713293|NCT01773473|E2|Reported Event|Insulin Lispro Mix50|Insulin Lispro Mix50 administered SC using prefilled pen twice daily for 26 weeks.
713294|NCT01773473|E1|Reported Event|Insulin Lispro Mix25|Insulin Lispro Mix25 administered SC using prefilled pen twice daily for 26 weeks.
713295|NCT01773291|B4|Baseline|Total|Total of all reporting groups
713296|NCT01773291|B3|Baseline|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
713297|NCT01773291|B2|Baseline|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
715064|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
713299|NCT01773291|P3|Participant Flow|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
713300|NCT01773291|P2|Participant Flow|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
713301|NCT01773291|P1|Participant Flow|Acupuncture|"acupuncture on Shuigou (GV26) and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
713302|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture"
713303|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
713304|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
713305|NCT01773291|O3|Outcome|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
713306|NCT01773291|O2|Outcome|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
713307|NCT01773291|O1|Outcome|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
713308|NCT01773291|E3|Reported Event|Control Group|"laser acupuncture without laser output in control group.~control: sham laser acupuncture on GV26 and 12 Well points"
713309|NCT01773291|E2|Reported Event|Laser Acupuncture|"laser acupuncture on GV26 and 12 Well points~laser acupuncture: laser acupuncture on GV26 and 12 Well points"
713310|NCT01773291|E1|Reported Event|Acupuncture|"acupuncture on GV26 and 12 Well points~acupuncture: acupuncture on GV26 and 12 Well points"
713311|NCT01773226|B1|Baseline|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713312|NCT01773226|P1|Participant Flow|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713313|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713314|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713315|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713316|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713317|NCT01773226|O1|Outcome|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713318|NCT01773226|E1|Reported Event|"Autologous Protein Solution APS(TM)"|"Patients who have been treated with a single, intra-articular injection.~Autologous Protein Solution APS(TM): A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins"
713319|NCT01773135|B3|Baseline|Total|Total of all reporting groups
713335|NCT01772576|B1|Baseline|Reliance 4-Front|"Single arm, all patients will be implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation should be from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713320|NCT01773135|B2|Baseline|Full Term Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered full term (after 37 weeks of gestation)"
713321|NCT01773135|B1|Baseline|Preterm Group|"pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.~this group delivered preterm (before 37 weeks of gestation)"
713322|NCT01773135|P1|Participant Flow|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
713323|NCT01773135|O2|Outcome|Full Term Group|group of patients who delivered after 37 weeks of gestation
713324|NCT01773135|O1|Outcome|Preterm Group|group of patients who delivered before 37 weeks of gestation
713325|NCT01773135|E1|Reported Event|Pregnant Women With Threatened Preterm Labor|"pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation > 1 and < 4 cm, and/or Cervical effacement ≥ 80%.~then, collection of blood sample and tocolysis adminstration will be done~investigators obtained a blood sample from all patient to measure the serum level of ACTH.~all patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
713326|NCT01772654|B3|Baseline|Total|Total of all reporting groups
713327|NCT01772654|B2|Baseline|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713328|NCT01772654|B1|Baseline|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713329|NCT01772654|P2|Participant Flow|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713330|NCT01772654|P1|Participant Flow|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713331|NCT01772654|O2|Outcome|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood. This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713332|NCT01772654|O1|Outcome|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713333|NCT01772654|E2|Reported Event|Control Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713334|NCT01772654|E1|Reported Event|Left Temporal Lobe Epilepsy Subjects|"Arterial Spin Labeled (ASL) MRI sequence~Arterial Spin Labeled (ASL) MRI sequence: The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
713388|NCT01772537|B3|Baseline|Open Repair|These patients received no intervention, just standard of care.
713336|NCT01772576|P1|Participant Flow|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713337|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713338|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713339|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713340|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713341|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713342|NCT01772576|O1|Outcome|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713343|NCT01772576|E1|Reported Event|Reliance 4-Front|"Single arm, all patients were implanted with the Reliance 4-Front lead~Reliance 4-Front lead implantation: The patients selected for participation were from the investigator’s general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system."
713344|NCT01772550|B4|Baseline|Total|Total of all reporting groups
713345|NCT01772550|B3|Baseline|20 GA BD Nexiva Diffusics - Nonrandomized|
713346|NCT01772550|B2|Baseline|18 GA Conventional Catheter - Randomized|
713347|NCT01772550|B1|Baseline|20 GA BD Nexiva Diffusics - Randomized|
713348|NCT01772550|P3|Participant Flow|20 GA BD Nexiva Diffusics - Nonrandomized|Subjects whose veins are not suitable for an 18GA IV catheter will be assigned to this non-randomized arm. During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20GA fenestrated BD Nexiva Diffusics single port IV catheter
713349|NCT01772550|P2|Participant Flow|18 GA Conventional Catheter - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the non-fenestrated 18GA x 1.25 inch Smiths Medical Jelco IV catheter
713350|NCT01772550|P1|Participant Flow|20 GA BD Nexiva Diffusics - Randomized|During their routinely scheduled CECT procedure, subjects receive IV contrast medium injected via the 20 GA fenestrated BD Nexiva Diffusics single port IV catheter
713351|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713352|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713353|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713354|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713355|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713356|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713357|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713358|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713359|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713360|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713361|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713362|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713363|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713364|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713365|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713366|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713367|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713368|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713369|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713370|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713371|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713372|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713373|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713374|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713375|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713376|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713377|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713378|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713379|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713380|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713381|NCT01772550|O3|Outcome|20 GA BD Nexiva Diffusics - Nonrandomized|
713382|NCT01772550|O2|Outcome|18 GA Conventional Catheter - Randomized|
713383|NCT01772550|O1|Outcome|20 GA BD Nexiva Diffusics - Randomized|
713384|NCT01772550|E3|Reported Event|20 GA BD Nexiva Diffusics - Nonrandomized|
713385|NCT01772550|E2|Reported Event|18 GA Conventional Catheter - Randomized|
713386|NCT01772550|E1|Reported Event|20 GA BD Nexiva Diffusics - Randomized|
713387|NCT01772537|B4|Baseline|Total|Total of all reporting groups
713389|NCT01772537|B2|Baseline|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
713390|NCT01772537|B1|Baseline|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
713391|NCT01772537|P3|Participant Flow|Open Repair|These patient will receive no intervention, just standard of care.
713392|NCT01772537|P2|Participant Flow|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
713393|NCT01772537|P1|Participant Flow|Stent Graft Repair Propofol|"Patients have a stent graft repair receiving intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
713394|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
713395|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
713396|NCT01772537|O3|Outcome|Stent Graft Aneurysm Repair Isoflurane|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Isoflurane as their primary anesthetic.
713397|NCT01772537|O2|Outcome|Delerium Staus Post Stenting of Aneuryms Propofol|These are participants that received stenting of thoracoabdominal aneurysms instead of an open repair and received Propofol as their primary anesthetic.
713398|NCT01772537|O1|Outcome|Delirum Status Post Open Thoracoabdominal Aneurysm Repair|These are participants that received open thoracoabdominal aneurysm repair instead of aneurysm stenting.
713399|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
713400|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
713401|NCT01772537|O2|Outcome|Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
713402|NCT01772537|O1|Outcome|Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
713403|NCT01772537|E3|Reported Event|Open Thoracoabdominal Aneurysm Repair|These are patients that received open thoracabdominal aneurysm repair instead of aneurysm stenting.
713404|NCT01772537|E2|Reported Event|Stent Graft Repair Isoflurane|"standard of care anesthetic - patients will be induced with 1-2 mg/kg of propofol and maintained with 0.5%-1.5% of isoflurane.~isoflurane"
713405|NCT01772537|E1|Reported Event|Stent Graft Repair Propofol|"Intravenous anesthetic - patients will be induced with 1-2mg/kg of Propofol and maintained with 25-200 mcg/kg/min of Propofol.~Propofol: Intravenous anesthetic"
713406|NCT01772368|B1|Baseline|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
713407|NCT01772368|P1|Participant Flow|All Participants|All subjects, regardless of the order of treatments to which they were randomized in this cross-over study.
713408|NCT01772368|O7|Outcome|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
713409|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
713410|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
713411|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
713412|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
713413|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
713414|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
713415|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
713416|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
713417|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
713418|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
713419|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
713420|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
713421|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
713422|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
713423|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
713424|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
713425|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
713426|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
713427|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
713428|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
713429|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
713430|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
713431|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
713432|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
713433|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
713434|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
713435|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
713436|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
713437|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
713438|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
713439|NCT01772368|O6|Outcome|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
713440|NCT01772368|O5|Outcome|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
713441|NCT01772368|O4|Outcome|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
713442|NCT01772368|O3|Outcome|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
713443|NCT01772368|O2|Outcome|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
713444|NCT01772368|O1|Outcome|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
713445|NCT01772368|E7|Reported Event|Fp MDPI 50 mcg X 2 BID|Patients used 2 inhalations of Fp MDPI 50 mcg (100 mcg total dose) twice daily during the 'washout' between treatment periods, so adverse events during this treatment were assigned to Fp MDPI 50 mcg.
713446|NCT01772368|E6|Reported Event|Advair Diskus 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate. This arm is the only arm which is open-label because the inhaler device was different than the MDPI used in the other treatment arms.
713447|NCT01772368|E5|Reported Event|FS MDPI 100/50 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 50 mcg salmeterol xinafoate.
713448|NCT01772368|E4|Reported Event|FS MDPI 100/25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 25 mcg salmeterol xinafoate.
713449|NCT01772368|E3|Reported Event|FS MDPI 100/12.5mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 12.5 mcg salmeterol xinafoate.
713450|NCT01772368|E2|Reported Event|FS MDPI 100/6.25 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate and 6.25 mcg salmeterol xinafoate.
713451|NCT01772368|E1|Reported Event|Fp MDPI 100 mcg|Subjects inhaled a single dose of 100 mcg fluticasone propionate.
713452|NCT01772316|B1|Baseline|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713453|NCT01772316|P1|Participant Flow|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 milligram (mg) given as 0.9 milliliter (mL) of a 180 milligram per milliliter (mg/mL) solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by subcutaneous (SC) injection and as a single fixed dose irrespective of body weight.
713454|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713455|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713456|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713457|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713458|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713459|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713460|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713461|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713462|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713463|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713464|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713465|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713495|NCT01772134|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713466|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713467|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713468|NCT01772316|O1|Outcome|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713469|NCT01772316|E1|Reported Event|Tocilizumab Subcutaneous (SC)|Participants received Tocilizumab 162 mg given as 0.9 mL of a 180 mg/mL solution administered once a week (for participants entering from NCT01194414) or once every two weeks (for participants entering from NCT01232569) by SC injection and as a single fixed dose irrespective of body weight.
713470|NCT01772147|B4|Baseline|Total|Total of all reporting groups
713471|NCT01772147|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713472|NCT01772147|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713473|NCT01772147|B1|Baseline|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713474|NCT01772147|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713475|NCT01772147|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713476|NCT01772147|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and FSC 250/50 µg twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713477|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713478|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713479|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713480|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713481|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713482|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713483|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713484|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713485|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713486|NCT01772147|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713487|NCT01772147|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713488|NCT01772147|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713489|NCT01772147|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713490|NCT01772147|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713491|NCT01772147|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713492|NCT01772134|B4|Baseline|Total|Total of all reporting groups
713493|NCT01772134|B3|Baseline|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713494|NCT01772134|B2|Baseline|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713496|NCT01772134|P3|Participant Flow|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713497|NCT01772134|P2|Participant Flow|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received umeclidinium bromide (UMEC) 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713498|NCT01772134|P1|Participant Flow|Placebo QD + FSC 250/50 µg BID|Participants received placebo once daily (QD) each morning via a dry powder inhaler (DPI) and fluticasone propionate and salmeterol (FSC) 250/50 micrograms (µg) twice daily (BID) (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713499|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713500|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713501|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713502|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713503|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713504|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713505|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713506|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713507|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713508|NCT01772134|O3|Outcome|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713509|NCT01772134|O2|Outcome|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713510|NCT01772134|O1|Outcome|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713511|NCT01772134|E3|Reported Event|UMEC 125 µg QD + FSC 250/50 µg BID|Participants received UMEC 125 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713512|NCT01772134|E2|Reported Event|UMEC 62.5 µg QD + FSC 250/50 µg BID|Participants received UMEC 62.5 µg QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713513|NCT01772134|E1|Reported Event|Placebo QD + FSC 250/50 µg BID|Participants received placebo QD each morning via a DPI and FSC 250/50 µg BID (one inhalation each morning and one inhalation each evening) via a DPI for 12 weeks.
713514|NCT01771991|B3|Baseline|Total|Total of all reporting groups
713515|NCT01771991|B2|Baseline|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
713584|NCT01770743|B5|Baseline|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
716478|NCT01761279|E1|Reported Event|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
713516|NCT01771991|B1|Baseline|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
713517|NCT01771991|P2|Participant Flow|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
713518|NCT01771991|P1|Participant Flow|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
713519|NCT01771991|O2|Outcome|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
713520|NCT01771991|O1|Outcome|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
713521|NCT01771991|E2|Reported Event|Placebo Group|"Cetaphil cream~Placebo: Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area."
713522|NCT01771991|E1|Reported Event|Topical Sodermix Dismutase|"Patients with measurable radiation induced fibrosis of the neck. Patients will be randomized to Topical Sodermix Dismutase in the form of Sodermix(SOD)~Topical Sodermix Dismutase in the form of Sodermix (SOD): Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area."
713523|NCT01771913|B3|Baseline|Total|Total of all reporting groups
713597|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713524|NCT01771913|B2|Baseline|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
713525|NCT01771913|B1|Baseline|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
713526|NCT01771913|P2|Participant Flow|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
713527|NCT01771913|P1|Participant Flow|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
713528|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
713529|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
713530|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
713531|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
713532|NCT01771913|O2|Outcome|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
713585|NCT01770743|B4|Baseline|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713533|NCT01771913|O1|Outcome|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
713534|NCT01771913|E2|Reported Event|ADSCs Enriched Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present volume insufficiency will undergo ADSCs enriched fat grafting for volume and irregularity contour improvement~ADSCs enriched fat graft: fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts."
713535|NCT01771913|E1|Reported Event|Centrifuged Fat Graft|"female patients who underwent breast reconstruction and present with volume insufficiency will undergo centrifuged fat graft for contour and volume refinements.~centrifuged fat graft: fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group."
713536|NCT01771172|B1|Baseline|Acute Defibrillation Testing|
713537|NCT01771172|P1|Participant Flow|Acute Defibrillation Testing|
713538|NCT01771172|O1|Outcome|Acute Defibrillation Testing|
713539|NCT01771172|E1|Reported Event|Acute Defibrillation Testing|
713540|NCT01770860|B1|Baseline|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
713598|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713599|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713541|NCT01770860|P1|Participant Flow|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
713542|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713543|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713544|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713545|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713546|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713547|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713548|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713549|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713550|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713551|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713552|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713553|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713554|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713555|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713556|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713557|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713558|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713559|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713560|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713561|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713562|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713563|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713564|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713565|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713566|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713567|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713568|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713569|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713570|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713571|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713572|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713573|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713574|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713575|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713576|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713577|NCT01770860|O5|Outcome|Bandage Dora the Explorer™|
713578|NCT01770860|O4|Outcome|Bandage QuiltVent™ Tough Strips Waterproof|
713579|NCT01770860|O3|Outcome|Bandage QuiltVent™ Flexible Fabric|
713580|NCT01770860|O2|Outcome|Bandage QuiltVent™ Sheer Strips|
713581|NCT01770860|O1|Outcome|Bandage QuiltVent™ Sheer Strips (With Pad Removed)|No treatment
713582|NCT01770860|E1|Reported Event|4 Commercially-available Bandage and 1 Control|Five dermabrasion wounds will be created on each subject's back by a licensed physician. Four of the wounds will be covered with four different commercially-available bandages (6660, 4314, 8336 and 4840), and one wound will be left open to the air to serve as a no treatment control (0000). Treatments and control will be randomized to application site.
713583|NCT01770743|B6|Baseline|Total|Total of all reporting groups
713586|NCT01770743|B3|Baseline|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713587|NCT01770743|B2|Baseline|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713588|NCT01770743|B1|Baseline|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713589|NCT01770743|P5|Participant Flow|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713590|NCT01770743|P4|Participant Flow|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713591|NCT01770743|P3|Participant Flow|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713592|NCT01770743|P2|Participant Flow|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713593|NCT01770743|P1|Participant Flow|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713594|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713595|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713596|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713797|NCT01769443|B3|Baseline|Total|Total of all reporting groups
713600|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713601|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713602|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713603|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713604|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713605|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713606|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713607|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713608|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713609|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713610|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713611|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713612|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713613|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713614|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713615|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713616|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713617|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713618|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713619|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713620|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713621|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713622|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713623|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713624|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713625|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713626|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713627|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713628|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713629|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713630|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713631|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713632|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713633|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713634|NCT01770743|O5|Outcome|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713635|NCT01770743|O4|Outcome|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713636|NCT01770743|O3|Outcome|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713637|NCT01770743|O2|Outcome|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713638|NCT01770743|O1|Outcome|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713639|NCT01770743|E5|Reported Event|BioThrax|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~BioThrax"
713640|NCT01770743|E4|Reported Event|AV7909 Reduced Dose|"Route of administration: Intramuscular Dose: 0.25 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713641|NCT01770743|E3|Reported Event|AV7909 (Day 0, 14, and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0, Day 14,and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713642|NCT01770743|E2|Reported Event|AV7909 (Day 0 and 28)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 28~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713643|NCT01770743|E1|Reported Event|AV7909 (Day 0 and 14)|"Route of administration: Intramuscular Dose: 0.5 mL Schedule: Day 0 and Day 14~AV7909: Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant"
713644|NCT01770691|B1|Baseline|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
713645|NCT01770691|P1|Participant Flow|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary. Not all subjects will use all SMD'S~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
713646|NCT01770691|O4|Outcome|Cleared TIPI Device (G3)|7 subjects used the cleared TIPI G3 for up to 8 hours
713647|NCT01770691|O3|Outcome|SMD 9|7 subjects used SMD 9 for up to 8 hours
713648|NCT01770691|O2|Outcome|SMD 12 2009|6 subjects used SMD 12 for up to 8 hours during 2009
713649|NCT01770691|O1|Outcome|SMD 12 2008|5 subjects used SMD 12 for up to 8 hours during 2008
713650|NCT01770691|E1|Reported Event|TIPI Vaginal Pessary|"Each subject will use different SMD'S (Slightly modified designs) of the TIPI vaginal pessary.~TIPI vaginal pessary: TIPI vaginal pessary G3 model, and TIPI SMD's"
713651|NCT01770652|B5|Baseline|Total|Total of all reporting groups
713652|NCT01770652|B4|Baseline|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713653|NCT01770652|B3|Baseline|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713654|NCT01770652|B2|Baseline|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713655|NCT01770652|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713656|NCT01770652|P4|Participant Flow|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713657|NCT01770652|P3|Participant Flow|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713658|NCT01770652|P2|Participant Flow|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713659|NCT01770652|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713660|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713661|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713662|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713663|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713664|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713665|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713666|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713667|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713668|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713669|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713670|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713671|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713672|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713673|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713674|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713675|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713676|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713677|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713678|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713679|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713680|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe impairment, defined as having an eGFR 15-19 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713681|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Mild impairment, defined as having an eGFR 30-59 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713682|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild impairment, defined as having an eGFR 60-89 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713683|NCT01770652|O1|Outcome|Normal Renal Function|"Healthy volunteers, defined as having an estimated glomerular filtration rate (eGFR) ≥90 mL/min/1.73m^2. All subjects received a single 33 mg/kg oral dose of deferiprone.~Deferiprone: Oral iron chelator"
713684|NCT01770652|O4|Outcome|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713685|NCT01770652|O3|Outcome|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713686|NCT01770652|O2|Outcome|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713687|NCT01770652|O1|Outcome|Normal Renal Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713688|NCT01770652|E4|Reported Event|Severe Renal Impairment|"Severe renal impairment as defined by an eGFR 15-19 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713862|NCT01769378|B3|Baseline|Total|Total of all reporting groups
713689|NCT01770652|E3|Reported Event|Moderate Renal Impairment|"Moderate renal impairment as defined by eGFR 30-59 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713690|NCT01770652|E2|Reported Event|Mild Renal Impairment|"Mild renal impairment defined as eGFR 60-89 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713691|NCT01770652|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|"Healthy volunteers as defined by an eGFR ≥90 mL/min/1.73m^2 as determined by the estimated glomerular filtration rate (eGFR) from the Modification of Diet in Renal Disease (MDRD) Study will receive a single 33mg/kg oral dose of deferiprone.~Deferiprone"
713692|NCT01770509|B3|Baseline|Total|Total of all reporting groups
713693|NCT01770509|B2|Baseline|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
713694|NCT01770509|B1|Baseline|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713695|NCT01770509|P2|Participant Flow|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
713696|NCT01770509|P1|Participant Flow|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713697|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
713698|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713699|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
715065|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
713700|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713701|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
713702|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713703|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
713704|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713705|NCT01770509|O2|Outcome|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
713706|NCT01770509|O1|Outcome|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713707|NCT01770509|E2|Reported Event|Application of NMBM|"Daily application of NMBM~NMBM: Daily application of NMBM in addition to compression therapy~Compression garments: Compression garments"
713708|NCT01770509|E1|Reported Event|Standard of Care|"Standard of care: Dressings +Compression garments~Compression garments: Compression garments"
713709|NCT01770483|B3|Baseline|Total|Total of all reporting groups
713710|NCT01770483|B2|Baseline|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713711|NCT01770483|B1|Baseline|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713712|NCT01770483|P2|Participant Flow|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713713|NCT01770483|P1|Participant Flow|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713714|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713715|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713716|NCT01770483|O2|Outcome|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713717|NCT01770483|O1|Outcome|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713718|NCT01770483|E2|Reported Event|Study Group|"Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~nitazoxanide : nitazoxanide 500mg twice daily~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
722874|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
713719|NCT01770483|E1|Reported Event|Control Group|"Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months~Ribavirin : ribazole~conventional interferon alfa : Inj interferon 3 Million International Units thrice weekly"
713720|NCT01770392|B1|Baseline|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
713721|NCT01770392|P1|Participant Flow|Overall Study|This was an open-label, two-period, fixed-sequence trial. During the first period 150 mg of nintedanib was administered orally in form of a soft gelatine capsule. In the second period, a single dose of 600 mg of rifampicin was administered orally via film-coated tablet every day for a week, then a single dose of nintedanib was administered. The administrations of nintedanib were separated by a washout period of at least 14 days.
713722|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
713723|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
713724|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg Rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
713725|NCT01770392|O1|Outcome|Nintedanib|150 mg of Nintedanib was given as a single dose on Day 1.
713726|NCT01770392|O2|Outcome|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
713727|NCT01770392|O1|Outcome|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
713728|NCT01770392|E4|Reported Event|Nintedanib + Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1, followed by a single dose of 150 mg nintedanib in the morning of Day 1.
713729|NCT01770392|E3|Reported Event|Rifampicin|600 mg rifampicin was given every evening from Day -7 to Day -1
713730|NCT01770392|E2|Reported Event|Washout Period|washout period of at least 14 days between the administrations of nintedanib. During this period no trial drug was administered
713731|NCT01770392|E1|Reported Event|Nintedanib|150 mg of nintedanib was given as a single dose on Day 1.
713732|NCT01770379|B4|Baseline|Total|Total of all reporting groups
713733|NCT01770379|B3|Baseline|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
713734|NCT01770379|B2|Baseline|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
713735|NCT01770379|B1|Baseline|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
713736|NCT01770379|P3|Participant Flow|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
713737|NCT01770379|P2|Participant Flow|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
713738|NCT01770379|P1|Participant Flow|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
713739|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
713740|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
713741|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
713742|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
713743|NCT01770379|O2|Outcome|AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
713744|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status
713745|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
713746|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
713747|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
713748|NCT01770379|O3|Outcome|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
713749|NCT01770379|O2|Outcome|AIN457 150mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
713750|NCT01770379|O1|Outcome|AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
713751|NCT01770379|E3|Reported Event|Placebo|At Wk 16, patients were classified: responders or non-responders. Placebo patients who were non responders were rerandomized at Wk 16 to AIN457 75 mg or AIN457 150 mg (1:1). Patients on placebo who were responders continued to receive placebo until Wk 24, these patients were re-randomized to receive AIN457 75 mg or AIN457 150 mg (1:1)
713752|NCT01770379|E2|Reported Event|Any AIN457 150 mg|150 mg secukinumab: Patients on secukinumab 150 mg continued to receive secukinumab 150 mg via PFS every 4 weeks regardless of responder status.
713753|NCT01770379|E1|Reported Event|Any AIN457 75 mg|75 mg secukinumab: Patients on secukinumab 75 mg continued to receive secukinumab 75 mg via PFS every 4 weeks regardless of responder status.
713754|NCT01770366|B3|Baseline|Total|Total of all reporting groups
713755|NCT01770366|B2|Baseline|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
713756|NCT01770366|B1|Baseline|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
713849|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
713850|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
713980|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713757|NCT01770366|P2|Participant Flow|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
713758|NCT01770366|P1|Participant Flow|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
713759|NCT01770366|O2|Outcome|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
713760|NCT01770366|O1|Outcome|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
713761|NCT01770366|E2|Reported Event|Intervention Condition|"Intervention participants will receive the Weight and Exercise Lifestyle Support (WELS) intervention, which involves use of a wireless activity monitor and weight scale, as well as access to a patient portal website displaying data from these devices.~Weight and Exercise Lifestyle Support (WELS): Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired."
713762|NCT01770366|E1|Reported Event|Usual Care|"Patients will receive usual care from the post-surgical clinic team.~Usual Care"
713763|NCT01770314|B3|Baseline|Total|Total of all reporting groups
713764|NCT01770314|B2|Baseline|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
713765|NCT01770314|B1|Baseline|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
713766|NCT01770314|P2|Participant Flow|Experimental|Participants were given instructions via email to review eleven online lessons about opioid medication safety. Instructions suggested that participants view one lesson per day for eleven consecutive days. Each educational lesson focused on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
713767|NCT01770314|P1|Participant Flow|Control|The control group was a waitlist control. Participants were given access to the experimental intervention program after the intervention period and follow up assessments were completed.
713768|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
713769|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
713863|NCT01769378|B2|Baseline|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713770|NCT01770314|O2|Outcome|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
713771|NCT01770314|O1|Outcome|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
713772|NCT01770314|E2|Reported Event|Control|The control group is a waitlist control. Participants will be given access to painACTION after the intervention period and follow up assessments are completed.
713773|NCT01770314|E1|Reported Event|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
713774|NCT01770145|B1|Baseline|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
713775|NCT01770145|P1|Participant Flow|APOKYN|"Subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
713776|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmet Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
713777|NCT01770145|O1|Outcome|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatment Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
713778|NCT01770145|E1|Reported Event|APOKYN|"In the study, subjects will complete an L-Dopa Baseline Period in which they record daily time to on following their regularly scheduled L-Dopa morning dose for 7 days. At the end of the baseline period, patients will start trimethobenzamide therapy during a minimum 3-Day Anti-Emetic Pretreatment Period. Patients determined to remain eligible at the end of the required Anti-Emetic Pretreatmetn Period will be initiated on APOKYN therapy by an investigator. Once the appropriate dose is identified by a study investigator, patients will inject APOKYN at their regularly scheduled levodopa morning dose time (levodopa will be delayed by 40 minutes) daily during a 7-day APOKYN Treatment Period and record time to on following the APOKYN injection."
713779|NCT01769586|B3|Baseline|Total|Total of all reporting groups
713780|NCT01769586|B2|Baseline|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
713781|NCT01769586|B1|Baseline|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
713782|NCT01769586|P2|Participant Flow|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
713783|NCT01769586|P1|Participant Flow|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
713784|NCT01769586|O2|Outcome|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
713785|NCT01769586|O1|Outcome|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
713786|NCT01769586|E2|Reported Event|Midazolam|"1.5 mg increments up to 3 times (maximum 4.5 mg)~Midazolam"
713787|NCT01769586|E1|Reported Event|Diphenhydramine|"Increments of 25 mcg to maximum of 3 times (total 75 mcg)~Diphenhydramine"
713788|NCT01769508|B1|Baseline|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713789|NCT01769508|P1|Participant Flow|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713864|NCT01769378|B1|Baseline|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713865|NCT01769378|P2|Participant Flow|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713790|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713791|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713792|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713793|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713794|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713795|NCT01769508|O1|Outcome|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713796|NCT01769508|E1|Reported Event|Combined Therapy|"Combined Modality Treatment of Radiation therapy, 5-Fluorouracil, Oxaliplatin and Lapatinib followed by Surgery~5-Fluorouracil: 5-FU, 225 mg/m2 IVCI, during XRT.~Oxaliplatin: Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.~Lapatinib: Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion~Radiation Therapy: Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6"
713798|NCT01769443|B2|Baseline|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713799|NCT01769443|B1|Baseline|No Desensitization|No desensitization therapy pre-transplantation
713800|NCT01769443|P2|Participant Flow|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713801|NCT01769443|P1|Participant Flow|No Desensitization|No desensitization therapy pre-transplantation
713802|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713803|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713804|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713805|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713866|NCT01769378|P1|Participant Flow|Dulaglutide|Dulaglutide 1.5 milligram (mg) administered subcutaneously (SQ) once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713867|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713868|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
716669|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
713806|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713807|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713808|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713809|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713810|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713811|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713812|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713813|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713981|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713814|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713815|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713816|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713817|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713818|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713819|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713820|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713821|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713822|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713823|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713824|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713825|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713826|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713827|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713828|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713829|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713976|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713830|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713831|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713832|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713833|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713834|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713835|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713836|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713837|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713838|NCT01769443|O2|Outcome|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713839|NCT01769443|O1|Outcome|No Desensitization|No desensitization therapy pre-transplantation
713840|NCT01769443|E2|Reported Event|Desensitization|"Plasmapheresis with concomitant bortezomib.~Plasmapheresis will be given for 3 consecutive days (treatment days 0, 1 and 2) within 2 weeks of Status I listing for heart transplantation. Plasmapheresis is a procedure that involves the extracorporeal separation of plasma from cellular blood components by centrifugation or membrane filtration, which removes the alloantibody. The plasma depleted blood is reconstituted with exogenous fresh-frozen plasma or albumin solution which is then infused back into the patient.~Four doses of bortezomib (1.3 mg/m^2) were administered intravenously on treatment days 0, 3, 7 and 10. The first dose was given between 4-8 hours after the first plasmapheresis session was completed and there was at least 96 hours between the second and third dose of bortezomib"
713841|NCT01769443|E1|Reported Event|No Desensitization|No desensitization therapy pre-transplantation
713842|NCT01769391|B3|Baseline|Total|Total of all reporting groups
713843|NCT01769391|B2|Baseline|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
713844|NCT01769391|B1|Baseline|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m^2) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
713845|NCT01769391|P2|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
713846|NCT01769391|P1|Participant Flow|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 mg per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
713847|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
713848|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
714033|NCT01768559|B4|Baseline|Total|Total of all reporting groups
713851|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
713852|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle.
713853|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
713854|NCT01769391|O1|Outcome|Necitumumab + Paclitaxel+ Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle."
713855|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
713856|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC=6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
713857|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
713858|NCT01769391|O2|Outcome|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m² administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
713859|NCT01769391|O1|Outcome|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin Area Under the Curve (AUC)6 (mg•min/mL) administered IV on Day 1 of every 3 week cycle."
713860|NCT01769391|E2|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 200 mg/m²) administered IV on Day 1 of every 3 week cycle. Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin may continue for a maximum of 6 cycles.
713861|NCT01769391|E1|Reported Event|Necitumumab +Paclitaxel+Carboplatin|"Necitumumab 800 milligram (mg) administered intravenously (IV) on Days 1 and 8 of every 3 week cycle.~Paclitaxel 200 milligram per square meter (mg/m²) administered IV on Day 1 of every 3 week cycle.~Carboplatin AUC6 administered IV on Day 1 of every 3 week cycle. The combination of paclitaxel-carboplatin and necitumumab may continue for a maximum of 6 cycles."
713869|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713870|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713871|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713872|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713873|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713874|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713875|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713876|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713877|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713878|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713879|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713880|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713881|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713882|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713883|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713884|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713885|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713886|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713887|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713888|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713889|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713890|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713891|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713892|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713893|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713894|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713895|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713896|NCT01769378|O2|Outcome|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713897|NCT01769378|O1|Outcome|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713898|NCT01769378|E2|Reported Event|Placebo|Placebo administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713899|NCT01769378|E1|Reported Event|Dulaglutide|Dulaglutide 1.5 mg administered SQ once weekly for 24 weeks added to the participant's prescribed glimepiride dose.
713900|NCT01769365|B4|Baseline|Total|Total of all reporting groups
713901|NCT01769365|B3|Baseline|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
713902|NCT01769365|B2|Baseline|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
713903|NCT01769365|B1|Baseline|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
713904|NCT01769365|P3|Participant Flow|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
713905|NCT01769365|P2|Participant Flow|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
713956|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713906|NCT01769365|P1|Participant Flow|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
713907|NCT01769365|O3|Outcome|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
713908|NCT01769365|O2|Outcome|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
713909|NCT01769365|O1|Outcome|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
713910|NCT01769365|E3|Reported Event|7-day Standard Triple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days~7-day standard triple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days"
713911|NCT01769365|E2|Reported Event|10-day Sequential Therapy|"pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days~10-day sequential therapy: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days"
713912|NCT01769365|E1|Reported Event|7-day Quadruple Therapy|"pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days~7-day quadruple therapy: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days"
713977|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713913|NCT01769339|B1|Baseline|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
713914|NCT01769339|P1|Participant Flow|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically (applied to skin) to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis (yeast infection of the vulva) were not cured clinically on Day 14.
713915|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
713916|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
713917|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
713918|NCT01769339|O1|Outcome|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
713919|NCT01769339|E1|Reported Event|Miconazole Plus Hydrocortisone|Participants applied miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14. Treatment continued till Day 28, if signs and symptoms of vulvar candidiasis were not cured clinically on Day 14.
713920|NCT01769326|B5|Baseline|Total|Total of all reporting groups
713921|NCT01769326|B4|Baseline|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
713922|NCT01769326|B3|Baseline|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
713923|NCT01769326|B2|Baseline|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
713924|NCT01769326|B1|Baseline|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
713925|NCT01769326|P4|Participant Flow|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
713926|NCT01769326|P3|Participant Flow|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
714009|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
724172|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
713927|NCT01769326|P2|Participant Flow|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
713928|NCT01769326|P1|Participant Flow|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
713929|NCT01769326|O2|Outcome|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
713930|NCT01769326|O1|Outcome|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
713931|NCT01769326|O2|Outcome|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
713932|NCT01769326|O1|Outcome|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
713933|NCT01769326|E4|Reported Event|Control Group for RAE|"Subject participates in 3 weeks of conventional arm exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional Arm Exercise: Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises"
713934|NCT01769326|E3|Reported Event|Resonating Arm Exerciser (RAE)|"Subject participates in 3 weeks of exercising with the experimental device: RAE at a minimum of 3 days per week, 1 hour per day with the exercise program~Resonating Arm Exerciser: The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm."
713978|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713979|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713935|NCT01769326|E2|Reported Event|Control Group for Music Glove|"Subject participates in 3 weeks of conventional hand exercise program, at a minimum of 3 days per week, 1 hour per day with the exercise program.~Conventional hand exercise: Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers"
713936|NCT01769326|E1|Reported Event|MusicGlove Group|"Subject participates in 3 weeks of exercising with the experimental device: MusicGlove at a minimum of 3 days per week, 1 hour per day with the exercise program~MusicGlove: The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips."
713937|NCT01769248|B3|Baseline|Total|Total of all reporting groups
713938|NCT01769248|B2|Baseline|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
713939|NCT01769248|B1|Baseline|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
713940|NCT01769248|P2|Participant Flow|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB, test arm for core biopsies, EUS-FNB"
713941|NCT01769248|P1|Participant Flow|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration using EUS-FNA needles. This was the standard of care arm"
713942|NCT01769248|O2|Outcome|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
713943|NCT01769248|O1|Outcome|Fine Needle Aspiration|"fine needle aspiration~Fine needle aspiration: Fine needle aspiration"
713944|NCT01769248|E2|Reported Event|Fine Needle Biopsy|"Fine needle biopsy~Fine needle biopsy: FNB"
713945|NCT01769248|E1|Reported Event|Fine Needle Aspiration|Fine needle aspiration: Fine needle aspiration
713946|NCT01769222|B3|Baseline|Total|Total of all reporting groups
713947|NCT01769222|B2|Baseline|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
713948|NCT01769222|B1|Baseline|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713949|NCT01769222|P2|Participant Flow|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
713950|NCT01769222|P1|Participant Flow|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713951|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
713952|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713953|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
713954|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713955|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
724173|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
713957|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
713958|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713959|NCT01769222|O2|Outcome|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
713960|NCT01769222|O1|Outcome|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713961|NCT01769222|E2|Reported Event|Ipilimumab 25 mg and Radiation Therapy|"Participants receive ipilimumab intratumorally on Day 1 and undergo local radiation therapy (10 Gy/fraction) within 48 hours for at least 3 fractions~Ipilimumab: Given intratumorally~Radiation therapy: Undergo local radiation therapy, 10 Gy x 3 fractions"
713962|NCT01769222|E1|Reported Event|Ipilimumab 25 mg|"Participants receive ipilimumab intratumorally on Day 1~Ipilimumab: Given intratumorally"
713963|NCT01769196|B3|Baseline|Total|Total of all reporting groups
713964|NCT01769196|B2|Baseline|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713965|NCT01769196|B1|Baseline|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713966|NCT01769196|P2|Participant Flow|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713967|NCT01769196|P1|Participant Flow|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713968|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713969|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713970|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713971|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713972|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713973|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713974|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713975|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713982|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713983|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713984|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713985|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713986|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713987|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713988|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713989|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713990|NCT01769196|O2|Outcome|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713991|NCT01769196|O1|Outcome|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713992|NCT01769196|E2|Reported Event|Simtuzumab Placebo|Simtuzumab placebo administered subcutaneously once a week
713993|NCT01769196|E1|Reported Event|Simtuzumab|Simtuzumab 125 mg/mL administered subcutaneously once a week
713994|NCT01769105|B3|Baseline|Total|Total of all reporting groups
713995|NCT01769105|B2|Baseline|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
713996|NCT01769105|B1|Baseline|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily, then a single Lipiflow-treatment"
713997|NCT01769105|P2|Participant Flow|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
713998|NCT01769105|P1|Participant Flow|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily, then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow treatment"
713999|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
714000|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
714001|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
714002|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
714003|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
714004|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
714005|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
714006|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
714007|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
714008|NCT01769105|O3|Outcome|Cross-over Lipiflow|Patients receive Lipiflow after performing Lid hygiene for 3 month
714010|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
714011|NCT01769105|O3|Outcome|Cross-over Lipiflow|patients received a single Lipiflow treatment after performing lid hygiene for 3 month
714012|NCT01769105|O2|Outcome|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
714013|NCT01769105|O1|Outcome|Standard Lid Hygiene Regime|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily"
714014|NCT01769105|E2|Reported Event|Lipiflow|"Patients receive a singe Lipiflow-treatment~Lipiflow: Patients receive a single Lipiflow-treatment"
714015|NCT01769105|E1|Reported Event|Standard Lid Hygiene Regime First, Then Lipiflow|"Patients receive detailed verbal and written instruction to perform lid hygiene twice daily first and then Lipiflow~Lid hygiene regime: Patients receive verbal and written instruction to perform lid hygiene twice daily and after 3 month a single Lipiflow-treatment"
714016|NCT01768676|B3|Baseline|Total|Total of all reporting groups
714017|NCT01768676|B2|Baseline|Placebo|placebo taken once daily in the evening
714018|NCT01768676|B1|Baseline|Avanafil|100 mg once daily in the evening
714019|NCT01768676|P2|Participant Flow|Placebo|placebo taken once daily in the evening
714020|NCT01768676|P1|Participant Flow|Avanafil|100 mg once daily in the evening
714021|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
714022|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
714023|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
714024|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
714025|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
714026|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
714027|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
714028|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
714029|NCT01768676|O2|Outcome|Placebo|placebo taken once daily in the evening
714030|NCT01768676|O1|Outcome|Avanafil|100 mg once daily in the evening
714031|NCT01768676|E2|Reported Event|Placebo|placebo taken once daily in the evening
714032|NCT01768676|E1|Reported Event|Avanafil|100 mg once daily in the evening
714034|NCT01768559|B3|Baseline|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
714035|NCT01768559|B2|Baseline|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
714036|NCT01768559|B1|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714037|NCT01768559|P3|Participant Flow|Insulin Glulisine TID|Insulin glulisine thrice daily (TID) SC up to Week 26 on top of insulin glargine with or without metformin.
714038|NCT01768559|P2|Participant Flow|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
714039|NCT01768559|P1|Participant Flow|Lixisenatide|Lixisenatide 10 mcg once daily (QD) subcutaneously (SC) for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714040|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of insulin glargine with or without metformin.
714041|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of insulin glargine with or without metformin.
714042|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714043|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714044|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714045|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714046|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714047|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714048|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714049|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714050|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714051|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714052|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714053|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714054|NCT01768559|O2|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714055|NCT01768559|O1|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714056|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714057|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714058|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714059|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714060|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714061|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714062|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714063|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714064|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714065|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714066|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714067|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714068|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714069|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714070|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714071|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714072|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714073|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714074|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714075|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714076|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714077|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714078|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714079|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714080|NCT01768559|O3|Outcome|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin.
714081|NCT01768559|O2|Outcome|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin.
714082|NCT01768559|O1|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin.
714083|NCT01768559|E3|Reported Event|Insulin Glulisine TID|Insulin glulisine TID SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
714084|NCT01768559|E2|Reported Event|Insulin Glulisine QD|Insulin glulisine QD SC up to Week 26 on top of Insulin glargine with or without metformin (Median exposure of 182 days).
714085|NCT01768559|E1|Reported Event|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 26 on top of insulin glargine with or without metformin (Median exposure of 182 days).
714086|NCT01768325|B3|Baseline|Total|Total of all reporting groups
714087|NCT01768325|B2|Baseline|ProCore Needle|
714088|NCT01768325|B1|Baseline|QuickCore Needle|
714089|NCT01768325|P2|Participant Flow|ProCore Needle|
714090|NCT01768325|P1|Participant Flow|Quick Core Needle|
714091|NCT01768325|O2|Outcome|ProCore Needle|
714092|NCT01768325|O1|Outcome|Quick Core Needle|
714093|NCT01768325|O2|Outcome|ProCore Needle|
714094|NCT01768325|O1|Outcome|Quick Core Needle|
714095|NCT01768325|O2|Outcome|ProCore Needle|"Core biopsy needle comparison to obtain diagnostic yield.~Cook Medical core biopsy needle: Obtaining a larger specimen."
714096|NCT01768325|O1|Outcome|Quick Core Needle|"Comparison of ProCore core biopsy needle to QuickCore core biopsy needle.Cook Medical core biopsy needle~Cook Medical core biopsy needle: Obtaining a larger specimen."
714097|NCT01768325|E2|Reported Event|ProCore Needle|
714098|NCT01768325|E1|Reported Event|Quick Core Needle|
714099|NCT01768286|B5|Baseline|Total|Total of all reporting groups
714100|NCT01768286|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714101|NCT01768286|B3|Baseline|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714102|NCT01768286|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714103|NCT01768286|B1|Baseline|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714104|NCT01768286|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714105|NCT01768286|P3|Participant Flow|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714106|NCT01768286|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
714107|NCT01768286|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet once daily for 12 weeks
714108|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714109|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714110|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714111|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714112|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714113|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714114|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714115|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714116|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714117|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714118|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714119|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714120|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714121|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714122|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714123|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714124|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714125|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714126|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714127|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714128|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714129|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714130|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714131|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714132|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714133|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714134|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714135|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714136|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714137|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714138|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714139|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714140|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714141|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714142|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714143|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714144|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714145|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714146|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714147|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714148|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714149|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714150|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714151|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714152|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714153|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714154|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714155|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714156|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714157|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714158|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714159|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
716670|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
714160|NCT01768286|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714161|NCT01768286|O3|Outcome|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714162|NCT01768286|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714163|NCT01768286|O1|Outcome|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714164|NCT01768286|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
714165|NCT01768286|E3|Reported Event|LDV/SOF 24 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 24 weeks
714166|NCT01768286|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily plus RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
714167|NCT01768286|E1|Reported Event|LDV/SOF 12 Weeks|LDV 90 mg/SOF 400 mg FDC tablet once daily for 12 weeks
714168|NCT01768117|B1|Baseline|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714169|NCT01768117|P1|Participant Flow|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714170|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714171|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714172|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714173|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714174|NCT01768117|O1|Outcome|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714175|NCT01768117|E1|Reported Event|rLP2086|Enrolled to receive on a 0, 2-, 6- month schedule
714176|NCT01768013|B1|Baseline|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714177|NCT01768013|P1|Participant Flow|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714425|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714178|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714179|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714180|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714181|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714182|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714183|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714184|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714185|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714186|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714187|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714449|NCT01766921|E2|Reported Event|Low Dose|Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart.
714188|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714189|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714190|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714191|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714192|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714193|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714194|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714246|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714195|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714196|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714197|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714198|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714199|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714200|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714201|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714202|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714203|NCT01768013|O1|Outcome|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714204|NCT01768013|E1|Reported Event|LEO 90105 Ointment|Subjects received once daily topical treatment with LEO 90105 (calcipotriol hydrate plus betamethasone dipropionate ointment) on all lesions on the trunk and/or limbs (excluding psoriasis on the genitals and skin folds) for 4 weeks. Subjects were supplied with an amount of medication at day 1, day 7 and day 14 such that the maximum usage of LEO 90105 could be 90 g per week.
714205|NCT01768000|B5|Baseline|Total|Total of all reporting groups
714206|NCT01768000|B4|Baseline|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714207|NCT01768000|B3|Baseline|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714208|NCT01768000|B2|Baseline|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714209|NCT01768000|B1|Baseline|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualized intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714210|NCT01768000|P4|Participant Flow|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714247|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714248|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714249|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714211|NCT01768000|P3|Participant Flow|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714212|NCT01768000|P2|Participant Flow|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714213|NCT01768000|P1|Participant Flow|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714214|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714215|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714216|NCT01768000|O2|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714263|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714264|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
724174|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
714217|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714218|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714219|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714220|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714221|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714222|NCT01768000|O4|Outcome|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714250|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714426|NCT01767103|E3|Reported Event|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
714223|NCT01768000|O3|Outcome|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714224|NCT01768000|O2|Outcome|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714225|NCT01768000|O1|Outcome|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714226|NCT01768000|E4|Reported Event|Control Group - Family Members|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714227|NCT01768000|E3|Reported Event|Family Cognitive Adaptation Training - Family Members|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714228|NCT01768000|E2|Reported Event|Control Group - Caregivers|Participants in this arm will support their family members as usual, and will not receive the Family CAT manual and DVD provided to those in the experimental arm of the study.
714229|NCT01768000|E1|Reported Event|Family Cognitive Adaptation Training - Caregivers|"Participants in this group will receive the Family CAT manual and DVD.~Family Cognitive Adaptation Training: Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual."
714230|NCT01767987|B3|Baseline|Total|Total of all reporting groups
714231|NCT01767987|B2|Baseline|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714232|NCT01767987|B1|Baseline|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714233|NCT01767987|P2|Participant Flow|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714234|NCT01767987|P1|Participant Flow|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714235|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714236|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714237|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714238|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714239|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714240|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714241|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714242|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714243|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714244|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714245|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714251|NCT01767987|O2|Outcome|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714252|NCT01767987|O1|Outcome|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714253|NCT01767987|E2|Reported Event|Placebo|"Oral treatment Intervention: Drug: Placebo~Placebo: Drug: Placebo Oral dose twice per day for 3 days leading up to PCI"
714254|NCT01767987|E1|Reported Event|Ranolazine|"Oral treatment Intervention: Drug: Ranolazine 1000 mg~Ranolazine: Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI"
714255|NCT01767701|B1|Baseline|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714256|NCT01767701|P1|Participant Flow|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714257|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714258|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714259|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714260|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714261|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily. The EDSS score is determined by the mean score over three months after treatment minus the mean score of the three months before treatment~Raltegravir: 400mg twice daily for 3 months"
714262|NCT01767701|O1|Outcome|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714346|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714265|NCT01767701|E1|Reported Event|Raltegravir|"All eligible patients will complete a 3 months observation period (no medications) followed by 3 months on treatment period. During the treatment period patients will be treated with open label raltegravir 400mg twice daily.~Raltegravir: 400mg twice daily for 3 months"
714266|NCT01767688|B3|Baseline|Total|Total of all reporting groups
714267|NCT01767688|B2|Baseline|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714268|NCT01767688|B1|Baseline|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714269|NCT01767688|P2|Participant Flow|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714270|NCT01767688|P1|Participant Flow|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714271|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714272|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714273|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714274|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714275|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714276|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714277|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714278|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
718195|NCT01749501|O1|Outcome|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
714279|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714280|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714281|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714282|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714283|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714284|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714285|NCT01767688|O2|Outcome|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714286|NCT01767688|O1|Outcome|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714287|NCT01767688|E2|Reported Event|Healthy Matched Control Group|Healthy participants matched according to mean age (±15 years), mean weight (±10 kg), and mean CLCr (±20 mL/min) or mean eGFR (±20 mL/min/1.73 m²) to same-gender participants with moderate hepatic impairment were enrolled in the Control group.
714288|NCT01767688|E1|Reported Event|Moderate Hepatic Impairment Group|Participants with Child-Pugh scores of 7-9 were enrolled in the Moderate Hepatic Impairment group.
714289|NCT01767597|B3|Baseline|Total|Total of all reporting groups
714290|NCT01767597|B2|Baseline|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
714291|NCT01767597|B1|Baseline|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
714292|NCT01767597|P2|Participant Flow|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
714293|NCT01767597|P1|Participant Flow|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
714294|NCT01767597|O2|Outcome|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
714295|NCT01767597|O1|Outcome|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
714296|NCT01767597|E2|Reported Event|Rapid Testing|"HBV infection status determined initially by a rapid test, then confirmed by enzyme-linked immuno-assay (ELISA).~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).~Rapid testing: A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day."
714297|NCT01767597|E1|Reported Event|ELISA Testing|"HBV infection status determined by enzyme-linked immuno-assay (ELISA)~ELISA testing: Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days)."
714298|NCT01767519|B4|Baseline|Total|Total of all reporting groups
714299|NCT01767519|B3|Baseline|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714300|NCT01767519|B2|Baseline|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714301|NCT01767519|B1|Baseline|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714328|NCT01767519|E1|Reported Event|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714302|NCT01767519|P3|Participant Flow|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714303|NCT01767519|P2|Participant Flow|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714304|NCT01767519|P1|Participant Flow|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714305|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714306|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714307|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714308|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714309|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714310|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714311|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714312|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714313|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714314|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714315|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714401|NCT01767103|B1|Baseline|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714316|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714317|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714318|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714319|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714320|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714321|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714322|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714323|NCT01767519|O3|Outcome|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714324|NCT01767519|O2|Outcome|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714325|NCT01767519|O1|Outcome|BOTOX®|Treatment Cycle 1: BOTOX injected at Day 1 with one solifenacin placebo capsule taken orally once daily for up to 24 weeks. After a minimum of 12 weeks, patients could request/qualify for a second BOTOX injection.
714326|NCT01767519|E3|Reported Event|Placebo|Treatment Cycle 1: One solifenacin placebo capsule taken orally once daily starting at Day 1 for up to 24 weeks with an intradetrusor injection of BOTOX placebo at Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714327|NCT01767519|E2|Reported Event|Solifenacin|Treatment Cycle 1: Oral solifenacin taken once daily starting at Day 1 for up to 24 weeks with intradetrusor injection of BOTOX placebo on Day 1. After a minimum of 12 weeks, patients could request/qualify for a BOTOX injection.
714329|NCT01767467|B3|Baseline|Total|Total of all reporting groups
718196|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
714330|NCT01767467|B2|Baseline|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714331|NCT01767467|B1|Baseline|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714332|NCT01767467|P2|Participant Flow|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714333|NCT01767467|P1|Participant Flow|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714334|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714335|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714336|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714337|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714338|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714339|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714340|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714341|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714342|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714343|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714344|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714345|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
716671|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
714347|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714348|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714349|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714350|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714351|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714352|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714353|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714354|NCT01767467|O1|Outcome|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714355|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714356|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714357|NCT01767467|O2|Outcome|Placebo Group|Subjects who received placebo doses according to a 0, 1 Months schedule. (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714358|NCT01767467|O1|Outcome|GSK1437173A Group|Subjects who received GSK1437173A vaccine according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714359|NCT01767467|E1|Reported Event|GSK1437173A/Placebo Group|Subjects who received GSK1437173A vaccine or placebo according to a 0, 1 Months schedule (The second dose of study vaccine/placebo could be administered 1 - 2 months after the first dose)
714360|NCT01767285|B3|Baseline|Total|Total of all reporting groups
714424|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714361|NCT01767285|B2|Baseline|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714362|NCT01767285|B1|Baseline|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714363|NCT01767285|P2|Participant Flow|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714364|NCT01767285|P1|Participant Flow|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714365|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714366|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714367|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714368|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714369|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714370|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714371|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714372|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714373|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714374|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714375|NCT01767285|O2|Outcome|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714376|NCT01767285|O1|Outcome|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714377|NCT01767285|E2|Reported Event|Delayed Postpartum Etonogestrel Implant|"These subjects will have the etonogestrel implant placed at the 6 week postpartum visit.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714378|NCT01767285|E1|Reported Event|Immediate Postpartum Etonogestrel Implant|"Etonogestrel implant placed in the hospital after delivery, before discharge home.~Etonogestrel implant: This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit."
714379|NCT01767116|B3|Baseline|Total|Total of all reporting groups
714380|NCT01767116|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714381|NCT01767116|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714382|NCT01767116|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714383|NCT01767116|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714384|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714385|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714386|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714387|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714388|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714389|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714390|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714391|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714392|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714393|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714394|NCT01767116|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714395|NCT01767116|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714396|NCT01767116|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus Placebo RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks plus placebo RBV (twice daily) for 12 weeks
714397|NCT01767116|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
714398|NCT01767103|B4|Baseline|Total|Total of all reporting groups
714399|NCT01767103|B3|Baseline|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
714400|NCT01767103|B2|Baseline|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714402|NCT01767103|P3|Participant Flow|Moderate Hepatic Failure|Moderate hepatic impairment as defined by Child-Pugh Class : 7-9 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
714403|NCT01767103|P2|Participant Flow|Mild Hepatic Failure|Mild hepatic impairment as defined by Child-Pugh Class C: 5-6 points. All subjects received a single 33 mg/kg oral dose of deferiprone.
714404|NCT01767103|P1|Participant Flow|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function. All subjects received a single 33 mg/kg oral dose of deferiprone.
714405|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
714406|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714407|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714408|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
714409|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714410|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714411|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
714412|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714413|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714414|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
714415|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714416|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714417|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by Child-Pugh Class B: 7-9 points
714418|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714419|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714420|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
714421|NCT01767103|O2|Outcome|Mild Hepatic Failure|Mild hepatic failure as defined by Child-Pugh Class C: 5-6 points
714422|NCT01767103|O1|Outcome|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714423|NCT01767103|O3|Outcome|Moderate Hepatic Failure|Moderate hepatic failure as defined by the Child-Pugh Class B: 7-9 points
714427|NCT01767103|E2|Reported Event|Mild Hepatic Failure|Mild hepatic failure as defined by the Child-Pugh Class C: 5-6 points
714428|NCT01767103|E1|Reported Event|Normal Hepatic Function (Healthy Volunteers)|Healthy volunteers with normal hepatic function
714429|NCT01766921|B3|Baseline|Total|Total of all reporting groups
714430|NCT01766921|B2|Baseline|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714431|NCT01766921|B1|Baseline|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714432|NCT01766921|P2|Participant Flow|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714433|NCT01766921|P1|Participant Flow|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714434|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714435|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714436|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714437|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714438|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714439|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714440|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714441|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714442|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714443|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714444|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714445|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714446|NCT01766921|O2|Outcome|Low Dose|Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714447|NCT01766921|O1|Outcome|High Dose|Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
714448|NCT01766921|E3|Reported Event|Total|Total of subjects in both high and low dose groups.
724175|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
714450|NCT01766921|E1|Reported Event|High Dose|Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.
714451|NCT01766778|B3|Baseline|Total|Total of all reporting groups
714452|NCT01766778|B2|Baseline|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714453|NCT01766778|B1|Baseline|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714454|NCT01766778|P2|Participant Flow|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714455|NCT01766778|P1|Participant Flow|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714456|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714457|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714458|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714459|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714460|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714461|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714462|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714463|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714464|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714465|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714466|NCT01766778|O2|Outcome|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
714467|NCT01766778|O1|Outcome|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714468|NCT01766778|E2|Reported Event|LAF237 (Vildagliptin) 50mg Twice Daily (BID)|Vildagliptin 50mg BID plus stabilized or maximum tolerated dose of Metformin
718197|NCT01749501|O1|Outcome|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
714469|NCT01766778|E1|Reported Event|LAF237 (Vildagliptin) 50mg Once Daily (QD)|Vildagliptin 50mg QD plus stabilized or maximum tolerated dose of Metformin
714470|NCT01766713|B3|Baseline|Total|Total of all reporting groups
714471|NCT01766713|B2|Baseline|Placebo|Placebo only
714472|NCT01766713|B1|Baseline|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
714473|NCT01766713|P2|Participant Flow|Placebo|Placebo
714474|NCT01766713|P1|Participant Flow|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
714475|NCT01766713|O2|Outcome|Placebo|Placebo
714476|NCT01766713|O1|Outcome|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
714477|NCT01766713|E2|Reported Event|Placebo|
714478|NCT01766713|E1|Reported Event|Ezetimibe|"10 mg/day of Ezetimibe~Ezetimibe"
714479|NCT01766466|B3|Baseline|Total|Total of all reporting groups
714480|NCT01766466|B2|Baseline|ITT Population - Ticagrelor 7 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 7 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 12 hours prior."
714481|NCT01766466|B1|Baseline|ITT Population - Ticagrelor 6 Doses|"On Day 1: Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours. Ticagrelor (180 mg) was administered at 0.5 h or 1.5 h after the initiation of cangrelor infusion. Patients were discharged and instructed to take 90 mg ticagrelor every 12 hours for 6 doses.~On Day 5: Cangrelor was administered after ticagrelor (90 mg)was discontinued 24 hours prior."
714482|NCT01766466|P4|Participant Flow|Day 5 - Ticagrelor (90mg) Dosing (7 Doses)|Ticagrelor (90mg) discontinued 12h prior to the initiation of a 2h cangrelor infusion.
714483|NCT01766466|P3|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 1.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 1.5h after the initiation of the cangrelor infusion.
714484|NCT01766466|P2|Participant Flow|Day 5 - Ticagrelor (90 mg) Dosing (6 Doses)|Ticagrelor (90mg) discontinued 24h prior to the initiation of a 2h cangrelor infusion.
714485|NCT01766466|P1|Participant Flow|Day 1 - Cangrelor + Ticagrelor (180mg) at 0.5h|Cangrelor IV (2h) + oral ticagrelor (180mg) administered at 0.5h after the initiation of the cangrelor infusion.
714486|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
714487|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
714488|NCT01766466|O1|Outcome|All Patients|
714489|NCT01766466|O3|Outcome|Ticagrelor Discontinued 12 h Prior to Cangrelor Infusion|
714490|NCT01766466|O2|Outcome|Ticagrelor Discontinued 24 h Prior to Cangrelor Infusion|
714491|NCT01766466|O1|Outcome|All Patients|
714492|NCT01766466|O3|Outcome|Cangrelor + Ticagrelor 180mg at 0.5 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
714493|NCT01766466|O2|Outcome|Cangrelor + Ticagrelor 180mg at 1.25 h of Cangrelor Infusion|Cangrelor was administered as IV infusion for 2 hours.
714494|NCT01766466|O1|Outcome|All Patients|
714495|NCT01766466|E2|Reported Event|Cangrelor + Ticagrelor 90mg (7 Doses)|Ticagrelor discontinued 12 h prior to cangrelor infusion
714496|NCT01766466|E1|Reported Event|Cangrelor + Ticagrelor 90mg (6 Doses)|Ticagrelor was discontinued 24 h prior to cangrelor infusion
714497|NCT01766440|B1|Baseline|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714498|NCT01766440|P1|Participant Flow|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714499|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714500|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714501|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714502|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714503|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714504|NCT01766440|O1|Outcome|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714505|NCT01766440|E1|Reported Event|Calcitriol 3 mcg/g Ointment|"Topical application every 12 hours for 14 consecutive days~Calcitriol 3 mcg/g ointment: Topical ointment; twice daily application"
714506|NCT01766336|B3|Baseline|Total|Total of all reporting groups
714507|NCT01766336|B2|Baseline|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
714508|NCT01766336|B1|Baseline|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
714509|NCT01766336|P2|Participant Flow|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
714510|NCT01766336|P1|Participant Flow|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
714511|NCT01766336|O2|Outcome|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
714512|NCT01766336|O1|Outcome|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
714513|NCT01766336|E2|Reported Event|Placebo/ELND005|Patients who received Placebo in AG201 and received ELND005 in this extension study AG251
714514|NCT01766336|E1|Reported Event|ELND005/ELND005|Patients who received ELND005 in AG201 and received ELND005 in this extension study AG251
714515|NCT01766310|B3|Baseline|Total|Total of all reporting groups
714516|NCT01766310|B2|Baseline|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
714517|NCT01766310|B1|Baseline|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
714518|NCT01766310|P2|Participant Flow|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
714519|NCT01766310|P1|Participant Flow|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
714520|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
714521|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
714522|NCT01766310|O2|Outcome|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
714523|NCT01766310|O1|Outcome|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
714524|NCT01766310|E2|Reported Event|Folic Acid|"Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study~Folic Acid"
714525|NCT01766310|E1|Reported Event|Placebo|"placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study~placebo: sugar tablet manufactured to mimic folic acid tablet"
714526|NCT01766076|B3|Baseline|Total|Total of all reporting groups
714527|NCT01766076|B2|Baseline|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
714528|NCT01766076|B1|Baseline|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC will be collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
714529|NCT01766076|P2|Participant Flow|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC were collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
714530|NCT01766076|P1|Participant Flow|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC collected for immune activation assays using flowcytometry"
714531|NCT01766076|O2|Outcome|Placebo|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC will be collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
714532|NCT01766076|O1|Outcome|Atorvastatin|"Intervention is be atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMC were collected for immune activation assays using flowcytometry"
714533|NCT01766076|E2|Reported Event|Placebo First, Then Atorvastatin|"Intervention for the placebo comparator arm is Placebo 2 tablets daily for 12 weeks PBMC wiere collected for immune activation assays using flowcytometry~Placebo: PBMC were collected for immune activation assays using flowcytometry"
714556|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714534|NCT01766076|E1|Reported Event|Atorvastatin First, Then Placebo|"Intervention is atorvastatin, Lipitor® (40mg) 2 tablets daily (as adjuvant to HAART) for 12 weeks.~PBMC were collected for immune activation assays using flowcytometry~'atorvastatin, Lipitor®': PBMCwere collected for immune activation assays using flowcytometry"
714535|NCT01766050|B1|Baseline|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714536|NCT01766050|P1|Participant Flow|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714537|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
714538|NCT01766050|O1|Outcome|Post Treatment|Days 12 through 46 (Day of Discharge from Study). No study drug was administered during this time.
714539|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714540|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714541|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714542|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714543|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714544|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714758|NCT01765764|E1|Reported Event|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
714545|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714546|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714547|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714548|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714549|NCT01766050|O1|Outcome|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714550|NCT01766050|O5|Outcome|All Participants|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714551|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714552|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714553|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714554|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714555|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714737|NCT01765764|B4|Baseline|Total|Total of all reporting groups
714557|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714558|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714559|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714560|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714561|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714562|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714563|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714564|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714565|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714566|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714757|NCT01765764|E2|Reported Event|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
714567|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714568|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714569|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered on Day 4.
714570|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day1.
714571|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714572|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714573|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714574|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714575|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day11.
714576|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714577|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714578|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 1.
714579|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
716672|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
714580|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714581|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714582|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714583|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714584|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714585|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714586|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714587|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1, 4, 7 and 11.
714588|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714589|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714590|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714591|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714592|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714593|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714594|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714595|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714596|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714597|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714598|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714599|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714600|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714601|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714602|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714603|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714604|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714605|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714606|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714607|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714608|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714609|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714610|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714611|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714612|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714613|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714614|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
718198|NCT01749501|E2|Reported Event|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
714615|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714616|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714617|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714618|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714619|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714620|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714621|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714622|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714623|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714624|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714625|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg IV infusion of belatacept over 30 minutes was administered only on Day 4.
714626|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714627|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714628|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714629|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714630|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714631|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714632|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714633|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714634|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714635|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714636|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714637|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714638|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714639|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714640|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714641|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714642|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714643|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714644|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714645|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714646|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714647|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714648|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714649|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Days 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714650|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714651|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714652|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714653|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714654|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714655|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714656|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714657|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714658|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714659|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714660|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714661|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714662|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714663|NCT01766050|O4|Outcome|Day 11 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 11.
714664|NCT01766050|O3|Outcome|Day 7 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 7.
714665|NCT01766050|O2|Outcome|Day 4 Inje Cocktail Plus Belatacept|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 4. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered only on Day 4.
714666|NCT01766050|O1|Outcome|Day 1 Inje Cocktail|Single oral dose of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) was administered on Day 1.
714667|NCT01766050|E1|Reported Event|Inje Cocktail Alone and Inje Cocktail Plus Belatacept|Single oral doses of Inje Cocktail consisting of: caffeine (200 mg), losartan (50 mg tablet), omeprazole (40 mg delayed-release capsule), dextromethorphan (30 mg), and midazolam (5 mg oral syrup) were administered on Days 1, 4, 7 and 11. A single 10 mg/kg intravenous (IV) infusion of belatacept over 30 minutes was administered on Day 4.
714668|NCT01766037|B3|Baseline|Total|Total of all reporting groups
714669|NCT01766037|B2|Baseline|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714670|NCT01766037|B1|Baseline|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714671|NCT01766037|P2|Participant Flow|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714672|NCT01766037|P1|Participant Flow|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714673|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714674|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714675|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714676|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714677|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714738|NCT01765764|B3|Baseline|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
714678|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714679|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714680|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714681|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714682|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714683|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714684|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714685|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714686|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714687|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714688|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714689|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714690|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714691|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714692|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714817|NCT01765465|P1|Participant Flow|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
714693|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714694|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714695|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714696|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714697|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714698|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714699|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714700|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714701|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714702|NCT01766037|O2|Outcome|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714703|NCT01766037|O1|Outcome|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714704|NCT01766037|E2|Reported Event|Lifestyle Therapy|"Lifestyle Therapy only~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714705|NCT01766037|E1|Reported Event|Aspiration Therapy|"Aspiration Therapy and Lifestyle Therapy~Aspiration Therapy (AspireAssist): Use of the AspireAssist device in aspiration therapy~Lifestyle Therapy: Lifestyle therapy is a behavioral, diet and physical activity education program"
714706|NCT01766024|B3|Baseline|Total|Total of all reporting groups
714707|NCT01766024|B2|Baseline|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
724176|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
714708|NCT01766024|B1|Baseline|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
714709|NCT01766024|P2|Participant Flow|Rebif → BCD-033|"Volunteers in this group initially will receive a single sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
714710|NCT01766024|P1|Participant Flow|BCD-033 → Rebif|"Volunteers in this group initially will receive a single sc injection of the study drug BCD-033 (interferon beta-1a) at a dose of 44 µg (on Day 1) and then, after at least 14 days, a single sc injection of the reference drug Rebif® (interferon beta-1a) at a dose of 44 µg.~Interferon beta-1a: Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days."
714711|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
714712|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
714713|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif (interferon beta-1a) a
714714|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033 (interferon beta-1a)
714715|NCT01766024|O2|Outcome|Rebif|the endpoint was assessed in all the volunteer who received Rebif
714716|NCT01766024|O1|Outcome|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
714717|NCT01766024|E2|Reported Event|Rebif|the endpoint was assessed in all the volunteer who received Rebif
714718|NCT01766024|E1|Reported Event|BCD-033|the endpoint was assessed in all the volunteer who received BCD-033
714719|NCT01765972|B1|Baseline|Overall|All subjects that were dispensed a study lens.
714720|NCT01765972|P4|Participant Flow|Spectacle/ Test 2/ Test 1/ Test 3|Subjects received spectacle and then received Test 2 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 3 (etafilcon A with print) .
714721|NCT01765972|P3|Participant Flow|Test 3/ Test 1/ Test 2/ Spectacle|Subjects received Test 3 (etafilcon A with print) and then received Test 1 (etafilcon A with Laceron) and then received Test 2 (etafilcon A with print) and then received spectacle.
714722|NCT01765972|P2|Participant Flow|Test 2/ Test 3/ Spectacle/ Test 1|Subjects received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print) and then received spectacle and then received Test 1 (etafilcon A with Laceron).
714818|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
714723|NCT01765972|P1|Participant Flow|Test 1/Spectacle/Test 2/ Test 3|Subjects received Test 1 (etafilcon A with Laceron) and then received spectacle and then received Test 2 (etafilcon A with print) and then received Test 3 (etafilcon A with print).
714724|NCT01765972|O4|Outcome|Spectacle|Subjects that wore spectacles in any of the 4 periods of this study.
714725|NCT01765972|O3|Outcome|Test 3 (Etafilcon A With Print)|Subjects that received Test 3 (etafilcon A with print) lens in any of the 4 periods of this study.
714726|NCT01765972|O2|Outcome|Test 2 (Etafilcon A With Lacreon With Print)|Subjects that received Test 2 (etafilcon A with Lacreon with print) lens in any of the 4 periods of this study.
714727|NCT01765972|O1|Outcome|Test 1 (Etafilcon A With Lacreon)|Subjects that received Test 1 (etafilcon A with Lacreon) lens in any of the 4 periods of this study.
714728|NCT01765972|E4|Reported Event|Test 3 (Etafilcon A With Print)|Subjects received Test 3 (etafilcon A with print) in any of the 4 periods of this study.
714729|NCT01765972|E3|Reported Event|Test 2 (Etafilcon A With Lacreon With Print)|Subjects received Test 2 (etafilcon A with Lacreon with print) in any of the 4 periods of this study.
714730|NCT01765972|E2|Reported Event|Test 1 (Etafilcon A With Lacreon)|Subjects received Test 1 (etafilcon A with Lacreon) in any of the 4 periods of this study.
714731|NCT01765972|E1|Reported Event|Spectacle|Subjects wore spectacles in any of the 4 periods of this study.
714732|NCT01765803|B1|Baseline|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
714733|NCT01765803|P1|Participant Flow|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
714734|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
714735|NCT01765803|O1|Outcome|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
714736|NCT01765803|E1|Reported Event|Mellaril (Thioridazine)|"A single 50 gm dose of thioridizine (Mellaril) will be given orally at the beginning of the study~Mellaril: Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment."
714739|NCT01765764|B2|Baseline|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
714740|NCT01765764|B1|Baseline|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
714741|NCT01765764|P3|Participant Flow|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
714742|NCT01765764|P2|Participant Flow|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
714743|NCT01765764|P1|Participant Flow|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
714744|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
714745|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
714746|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
714747|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
714748|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
714749|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
714750|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
714751|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
714752|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
714753|NCT01765764|O3|Outcome|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
714754|NCT01765764|O2|Outcome|Bimatoprost Solution QD|Vehicle to bimatoprost solution in the morning and bimatoprost solution once a day (QD) in the evening applied to each eyebrow for 7 months.
714755|NCT01765764|O1|Outcome|Bimatoprost Solution BID|Bimatoprost solution twice a day (BID) in the morning and in the evening applied to each eyebrow for 7 months.
714756|NCT01765764|E3|Reported Event|Vehicle to Bimatoprost Solution BID|Vehicle to bimatoprost twice a day (BID) in the morning and the evening applied to each eyebrow for 7 months.
714759|NCT01765569|B1|Baseline|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
714760|NCT01765569|P1|Participant Flow|Vemurafenib + Digoxin|"Single oral dose of digoxin 0.25 mg tablet on Day 1 in Period A, followed by vemurafenib 960 mg orally BID from Day 8 to Day 28 in Period B, and then single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35 in Period C.~Digoxin: Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.~Vemurafenib: Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35."
714761|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714762|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
714763|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714764|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
714765|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714766|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
714767|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714768|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
714769|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714770|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
714771|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714772|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
714773|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714774|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
714775|NCT01765569|O2|Outcome|Period C (Digoxin + Vemurafenib)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 29 and vemurafenib 960 mg tablet orally BID from Day 29 to Day 35.
714776|NCT01765569|O1|Outcome|Period A (Digoxin)|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1.
724177|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
714777|NCT01765569|E3|Reported Event|Period C|Single oral dose of digoxin 0.25 mg on Day 29, and vemurafenib 960 mg orally BID from Day 29 to Day 35.
714778|NCT01765569|E2|Reported Event|Period B|Vemurafenib 960 mg orally BID from Day 8 to Day 28.
714779|NCT01765569|E1|Reported Event|Period A|Single oral dose of digoxin 0.25 mg tablet on Day 1.
714780|NCT01765543|B1|Baseline|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
714781|NCT01765543|P1|Participant Flow|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib (Zelboraf) at a dose of 960 milligrams (mg) as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
714782|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714783|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714784|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714785|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714786|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714787|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714819|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
714788|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714789|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714790|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714791|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714792|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714793|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714794|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714795|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714796|NCT01765543|O2|Outcome|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally along with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714797|NCT01765543|O1|Outcome|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714798|NCT01765543|E4|Reported Event|Vemurafenib + Rifampin (All Periods)|There were 3 intervention periods in the study: Period A (Days 1 to 7), Period B (Days 8 to 16), and Period C (Days 17 to 24). Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally alone on Day 1 (Period A); with rifampin (at a dose of 600 mg as capsules orally) on Day 17 (Period C); and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 8 through 16 (Period B) and from Days 18 through 23 (Period C).
714837|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714799|NCT01765543|E3|Reported Event|Vemurafenib + Rifampin (Intervention Period C)|Participants, after an overnight fast of at least 10 hours, received vemurafenib at a dose of 960 mg as film-coated tablets orally with rifampin at a dose of 600 mg as capsules orally on Day 17 and rifampin alone at a dose of 600 mg as capsules orally once daily was administered from Days 18 through 23.
714800|NCT01765543|E2|Reported Event|Rifampin (Intervention Period B)|Participants received rifampin alone at a dose of 600 mg as capsules orally once daily from Days 8 through 16.
714801|NCT01765543|E1|Reported Event|Vemurafenib (Intervention Period A)|Participants, after an overnight fast of at least 10 hours, received vemurafenib alone at a dose of 960 mg as film-coated tablets orally on Day 1.
714802|NCT01765530|B3|Baseline|Total|Total of all reporting groups
714803|NCT01765530|B2|Baseline|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
714804|NCT01765530|B1|Baseline|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
714805|NCT01765530|P2|Participant Flow|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
714806|NCT01765530|P1|Participant Flow|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
714807|NCT01765530|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
714808|NCT01765530|O1|Outcome|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
714809|NCT01765530|O2|Outcome|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
714810|NCT01765530|O1|Outcome|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
714811|NCT01765530|E2|Reported Event|Standard of Care|In the protocol no intervention is planned for the control group, which will therefore be treated with blind suctioning as per caregiver clinical decision.
714812|NCT01765530|E1|Reported Event|ETT Cleaning Manuver|Patients randomized to the treatment group will undergo an ETT cleaning maneuver with endOclear three times a day (every 8 hours) for the whole intubation period in addition to the standard of care.
714813|NCT01765465|B3|Baseline|Total|Total of all reporting groups
714814|NCT01765465|B2|Baseline|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
714815|NCT01765465|B1|Baseline|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
714816|NCT01765465|P2|Participant Flow|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
714820|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
714821|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
714822|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1-day to 3-month~Placebo"
714823|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1-day to 3-month~Rowachol"
714824|NCT01765465|O2|Outcome|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
714825|NCT01765465|O1|Outcome|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
714826|NCT01765465|E2|Reported Event|Placebo|"Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months~Placebo"
714827|NCT01765465|E1|Reported Event|Rowachol|"Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months~Rowachol"
714828|NCT01765426|B5|Baseline|Total|Total of all reporting groups
714829|NCT01765426|B4|Baseline|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714830|NCT01765426|B3|Baseline|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714831|NCT01765426|B2|Baseline|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714832|NCT01765426|B1|Baseline|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714833|NCT01765426|P4|Participant Flow|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714834|NCT01765426|P3|Participant Flow|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714835|NCT01765426|P2|Participant Flow|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714836|NCT01765426|P1|Participant Flow|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714838|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714839|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714840|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714841|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714842|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714843|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714844|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714845|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714846|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714847|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714848|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
715061|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
714849|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714850|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714851|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714852|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714853|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714854|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714855|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714856|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714857|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714858|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714859|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714860|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714861|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714862|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714863|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714864|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714865|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714866|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714867|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714868|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714869|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714870|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714871|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714872|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
718199|NCT01749501|E1|Reported Event|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
714873|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714874|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714875|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714876|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714877|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714878|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714879|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714880|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714881|NCT01765426|O4|Outcome|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714882|NCT01765426|O3|Outcome|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714883|NCT01765426|O2|Outcome|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714884|NCT01765426|O1|Outcome|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714885|NCT01765426|E4|Reported Event|Group 4: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714886|NCT01765426|E3|Reported Event|Group 3: TDV Using Needle and Syringe|TDV one dose injection in arm 1 and placebo: PBS one dose injection in arm 2, using needle and syringe, intradermal, on Day 0 and TDV injection using needle and syringe, intradermal, one dose on Day 90.
714887|NCT01765426|E2|Reported Event|Group 2: TDV Using PharmaJet® Injector|TDV injection, one dose in each arm, using needle-free PharmaJet® Injector, intradermal, on Day 0 and placebo: PBS, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714888|NCT01765426|E1|Reported Event|Group 1: TDV Using PharmaJet® Injector|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) [previously DENVax] one dose injection in arm 1 and placebo: phosphate buffered saline (PBS) one dose injection in arm 2, using needle-free PharmaJet® Injector, intradermal, on Day 0 and TDV, injection using needle-free PharmaJet® Injector, intradermal, one dose on Day 90.
714889|NCT01765270|B3|Baseline|Total|Total of all reporting groups
714890|NCT01765270|B2|Baseline|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714891|NCT01765270|B1|Baseline|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714892|NCT01765270|P2|Participant Flow|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714893|NCT01765270|P1|Participant Flow|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before coronary artery bypass graft (CABG) surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714894|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714895|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714896|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714897|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.daily
719308|NCT01741792|O2|Outcome|Blinatumomab 28 μg/d|Participants received blinatumomab CIV 28 µg/day.
714898|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714899|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714900|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714901|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714902|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714903|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714904|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714905|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714906|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714907|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714908|NCT01765270|O2|Outcome|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714909|NCT01765270|O1|Outcome|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714910|NCT01765270|E2|Reported Event|Placebo|Treatments to be administered are placebo 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
715256|NCT01763918|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
714911|NCT01765270|E1|Reported Event|Saxagliptin|Treatments to be administered are saxagliptin 5 mg (once daily) to begin at randomization 5 to 7 days before CABG surgery, continuing through the peri-CABG surgery period and discharge, and for a total of 30 (± 5) days post-CABG surgery.
714912|NCT01765192|B3|Baseline|Total|Total of all reporting groups
714913|NCT01765192|B2|Baseline|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714914|NCT01765192|B1|Baseline|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714915|NCT01765192|P2|Participant Flow|Placebo Plus Montelukast, Then Roflumilast Plus Montelukast|Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714916|NCT01765192|P1|Participant Flow|Roflumilast Plus Montelukast, Then Placebo Plus Montelukast|Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714917|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714918|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714919|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714920|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714921|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714922|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714923|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714924|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714925|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714926|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714927|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714928|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714929|NCT01765192|O2|Outcome|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714930|NCT01765192|O1|Outcome|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714931|NCT01765192|E2|Reported Event|Placebo Plus Montelukast|Participants received placebo plus montelukast 10 mg orally once daily for 4 weeks.
714932|NCT01765192|E1|Reported Event|Roflumilast Plus Montelukast|Participants received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
714933|NCT01765153|B3|Baseline|Total|Total of all reporting groups
714934|NCT01765153|B2|Baseline|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training was 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714935|NCT01765153|B1|Baseline|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714936|NCT01765153|P2|Participant Flow|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training, which is followed by another 2-month rest.
714937|NCT01765153|P1|Participant Flow|Endurance First|Participants start with Endurance Training. Participants trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then returned for Precision Training 5x/wk for 2 months. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714938|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714939|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714940|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714941|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714942|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714943|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714944|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714945|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714946|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
714947|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714948|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714949|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714950|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
714951|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714952|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
714953|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714954|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714955|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714956|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714957|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714958|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714959|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714960|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714961|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714962|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714963|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714964|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714965|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714966|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714967|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714968|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714969|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714970|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714971|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714972|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714973|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714974|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714975|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714976|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714977|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714978|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714979|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714980|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714981|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714982|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714983|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714984|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714985|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714986|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714987|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714988|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714989|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714990|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714991|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714992|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714993|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714994|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714995|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714996|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714997|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
714998|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
714999|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715000|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715001|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715002|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715003|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715004|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715005|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715006|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715007|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715008|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715009|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715010|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715011|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715012|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715013|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715014|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
715015|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715016|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715017|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715018|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715019|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715020|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715021|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715022|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
715023|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715024|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
715025|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715026|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
715027|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715028|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
715029|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715030|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. This is followed by another 2-month rest.
715031|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715032|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715033|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Trainingis 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for training in the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715034|NCT01765153|O2|Outcome|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715035|NCT01765153|O1|Outcome|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715036|NCT01765153|E2|Reported Event|Precision First|Participants start with Precision Training. Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for Endurance Training 5x/wk for 2 months. Participants are trained to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. followed by another 2-month rest.
715037|NCT01765153|E1|Reported Event|Endurance First|Participants start with Endurance Training. Participants are trained daily to walk on a treadmill as fast and as long as possible. A harness supporting part of their body weight is used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training. Training is 5x/wk for 2 months, followed by a 2-month rest period. Participants then return for the Precision Training 5x/wk for 2 months.Participants train to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto. This is followed by another 2-month rest.
715038|NCT01764945|B9|Baseline|Total|Total of all reporting groups
715039|NCT01764945|B8|Baseline|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715040|NCT01764945|B7|Baseline|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715041|NCT01764945|B6|Baseline|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715062|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
715042|NCT01764945|B5|Baseline|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715043|NCT01764945|B4|Baseline|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715044|NCT01764945|B3|Baseline|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715045|NCT01764945|B2|Baseline|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715046|NCT01764945|B1|Baseline|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715047|NCT01764945|P8|Participant Flow|120mg Faldaprevir: Sequence Group HGEF|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is HGEF with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715048|NCT01764945|P7|Participant Flow|120mg Faldaprevir: Sequence Group GFHE|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is GFHE with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715257|NCT01763918|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715049|NCT01764945|P6|Participant Flow|120mg Faldaprevir: Sequence Group FEGH|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is FEGH with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715050|NCT01764945|P5|Participant Flow|120mg Faldaprevir: Sequence Group EHFG|"120 mg group: The reference treatment was a single 120 mg dose (consisting of three 40 mg faldaprevir soft gelatine capsules, treatment E) and the test treatments were single 120 mg doses of 3 different faldaprevir oral solutions (treatments F, G, and H).~The order of treatment administration in this sequence group is EHFG with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715051|NCT01764945|P4|Participant Flow|40mg Faldaprevir: Sequence Group DCAB|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is DCAB with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715052|NCT01764945|P3|Participant Flow|40mg Faldaprevir: Sequence Group CBDA|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is CBDA with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715053|NCT01764945|P2|Participant Flow|40mg Faldaprevir: Sequence Group BACD|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is BACD with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715054|NCT01764945|P1|Participant Flow|40mg Faldaprevir: Sequence Group ADBC|"40 mg group: The reference treatment was a single 40 mg dose of faldaprevir soft gelatine capsule (treatment A) and the test treatments were single 40 mg doses of 3 different faldaprevir oral solutions (treatments B, C, and D).~The order of treatment administration in this sequence group is ADBC with washout phases of at least 14 days between drug administrations.~Oral administration (under fed conditions, i.e. following a high-fat breakfast)."
715055|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
715056|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
715057|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
715058|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
715059|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
715060|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
715066|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
715067|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
715068|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
715069|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
715070|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
715071|NCT01764945|O8|Outcome|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3
715072|NCT01764945|O7|Outcome|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2
715073|NCT01764945|O6|Outcome|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1
715074|NCT01764945|O5|Outcome|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
715075|NCT01764945|O4|Outcome|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3
715076|NCT01764945|O3|Outcome|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2
715077|NCT01764945|O2|Outcome|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1
715078|NCT01764945|O1|Outcome|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
715079|NCT01764945|E8|Reported Event|120mg Faldaprevir: Treatment H|120 mg faldaprevir oral solution 3.
715080|NCT01764945|E7|Reported Event|120mg Faldaprevir: Treatment G|120 mg faldaprevir oral solution 2.
715081|NCT01764945|E6|Reported Event|120mg Faldaprevir: Treatment F|120 mg faldaprevir oral solution 1.
715082|NCT01764945|E5|Reported Event|120mg Faldaprevir: Treatment E|120 mg faldaprevir soft gelatine capsule (reference).
715083|NCT01764945|E4|Reported Event|40mg Faldaprevir: Treatment D|40 mg faldaprevir oral solution 3.
715084|NCT01764945|E3|Reported Event|40mg Faldaprevir: Treatment C|40 mg faldaprevir oral solution 2.
715085|NCT01764945|E2|Reported Event|40mg Faldaprevir: Treatment B|40 mg faldaprevir oral solution 1.
715086|NCT01764945|E1|Reported Event|40mg Faldaprevir: Treatment A|40 mg faldaprevir soft gelatine capsule (reference).
715087|NCT01764919|B1|Baseline|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715088|NCT01764919|P1|Participant Flow|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715089|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715090|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715091|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715092|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715093|NCT01764919|O1|Outcome|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715094|NCT01764919|E1|Reported Event|[124I]FIAU|"Single intravenous injection of [124I]FIAU in patients with diabetic foot infection~[124I]FIAU: A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning."
715095|NCT01764841|B5|Baseline|Total|Total of all reporting groups
715096|NCT01764841|B4|Baseline|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
715097|NCT01764841|B3|Baseline|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
715098|NCT01764841|B2|Baseline|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715099|NCT01764841|B1|Baseline|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715100|NCT01764841|P4|Participant Flow|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
715101|NCT01764841|P3|Participant Flow|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
715102|NCT01764841|P2|Participant Flow|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715234|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715103|NCT01764841|P1|Participant Flow|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715104|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
715105|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
715106|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715107|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715108|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
715109|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
715110|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715111|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715112|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
715258|NCT01763918|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715113|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715114|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715115|NCT01764841|O4|Outcome|Placebo 14 Days on/Off (Placebo 14)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 cycles).
715116|NCT01764841|O3|Outcome|Placebo 28 Days on/Off (Placebo 28)|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 cycles).
715117|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715118|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715119|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
715120|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715121|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715122|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
715123|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
719539|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
715124|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715125|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
715126|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715127|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715128|NCT01764841|O3|Outcome|Pooled Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of a 28-day or 14-day on-treatment phase followed by a 28-day or 14-day off-treatment phase (48 weeks treatment phase = 6 or 12 cycles).
715129|NCT01764841|O2|Outcome|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715130|NCT01764841|O1|Outcome|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 milligram (mg) corresponding to 50 mg dry powder for inhalation (DPI) administered twice daily (BID) (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715131|NCT01764841|E3|Reported Event|Pooled Placebo|Participants received matching placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours); a treatment cycle consisted of either a 28-day days on-treatment phase followed by 28-day off-treatment phase or 14-day on-treatment phase followed by 14-day off treatment phase (48 weeks treatment phase = 6 cycles and 12 cycles, respectively).
715132|NCT01764841|E2|Reported Event|Ciprofloxacin DPI 14 Days on/Off (Cipro 14)|Participants received ciprofloxacin 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 14-day on-treatment phase followed by a 14-day off-treatment phase (48 weeks treatment phase = 12 active cycles).
715259|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715133|NCT01764841|E1|Reported Event|Ciprofloxacin DPI 28 Days on/Off (Cipro 28)|Participants received ciprofloxacin (BAYQ3939) 32.5 mg corresponding to 50 mg DPI administered BID (every 12 hours); a treatment cycle consisted of a 28-day on-treatment phase followed by a 28-day off-treatment phase (48 weeks treatment phase = 6 active cycles).
715134|NCT01764685|B3|Baseline|Total|Total of all reporting groups
715135|NCT01764685|B2|Baseline|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
715136|NCT01764685|B1|Baseline|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 mins) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
715137|NCT01764685|P2|Participant Flow|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
715149|NCT01764386|B2|Baseline|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715150|NCT01764386|B1|Baseline|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715235|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715138|NCT01764685|P1|Participant Flow|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 weeks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150 mg/day~Medical Management: (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
715139|NCT01764685|O2|Outcome|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
715140|NCT01764685|O1|Outcome|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 wks + Medical Management sessions for 15-25 mins per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/wk."
715158|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715141|NCT01764685|E2|Reported Event|Placebo Pill + Medical Management|"Sugar pill with dosing schedule matched to intervention group + Medical Management sessions for 15-25 minutes per study visit~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week."
715142|NCT01764685|E1|Reported Event|Topiramate + Medical Management|"Topiramate titrated up to 150 mg/day over 5 wks then maintained for 6 weeks + Medical Management sessions for 15-25 minutes per study visit~Topiramate: Max therapeutic dose of 150mg/day~Medical Management: Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drink"
715143|NCT01764607|B1|Baseline|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
715144|NCT01764607|P1|Participant Flow|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
715145|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
715146|NCT01764607|O1|Outcome|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
715147|NCT01764607|E1|Reported Event|Sirolimus Treatment|"Patients will receive sirolimus 5 weeks prior to removal of squamous cell skin carcinoma. After the 5 weeks of treatment, nephrology will determine/manage each patient's immunosuppressant therapy.~Sirolimus: Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy."
715148|NCT01764386|B3|Baseline|Total|Total of all reporting groups
715227|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
719540|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
715151|NCT01764386|P2|Participant Flow|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to Usual Care were switched to NB+CLI for the duration of the study (Week 78)."
715152|NCT01764386|P1|Participant Flow|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26. The Uncontrolled Treatment Period was from Week 26 to Week 78. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study (Week 78)."
715153|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715154|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715155|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715156|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715157|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715159|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715160|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715161|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715162|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715163|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715164|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715165|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715166|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715167|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715168|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715169|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715170|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715228|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715229|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715171|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715172|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715173|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715174|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715175|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715176|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715177|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715178|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715179|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715254|NCT01763918|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715180|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715181|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715182|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715183|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715184|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715185|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715186|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715187|NCT01764386|O2|Outcome|Usual Care|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff."
715188|NCT01764386|O1|Outcome|NB + CLI|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools."
715189|NCT01764386|E3|Reported Event|All Subjects (Entire Study)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~All Subjects (Entire Study) consisted of all subjects in both the Controlled and Uncontrolled Treatment Periods. At the end of the Controlled Treatment Period (Week 26), subjects assigned to NB+CLI continued with NB+CLI for the duration of the study and subjects assigned to Usual Care were switched to NB+CLI for the duration of the study."
715190|NCT01764386|E2|Reported Event|Usual Care (Controlled Treatment Period)|"Usual Care (self-directed lifestyle intervention)~Usual Care: Usual Care was a self-directed lifestyle intervention in which subjects were given calorie targets, instructions to increase exercise, and a pamphlet about weight loss by study site staff.~The Controlled Treatment Period was from Day 1 to Week 26."
715230|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715231|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715191|NCT01764386|E1|Reported Event|NB + CLI (Controlled Treatment Period)|"Naltrexone SR 32 mg/Bupropion SR 360 mg/day (NB) with Comprehensive Lifestyle Intervention (CLI)~NB: Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)~CLI: The Comprehensive Lifestyle Intervention (CLI) program included telephone counseling, internet education, goal setting, and online tracking tools.~The Controlled Treatment Period was from Day 1 to Week 26."
715192|NCT01764022|B3|Baseline|Total|Total of all reporting groups
715193|NCT01764022|B2|Baseline|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715194|NCT01764022|B1|Baseline|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715195|NCT01764022|P2|Participant Flow|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715196|NCT01764022|P1|Participant Flow|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715197|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715255|NCT01763918|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716673|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715198|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715199|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715200|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715201|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715202|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715203|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715204|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715205|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715206|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715207|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715232|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715233|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715208|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715209|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715210|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715211|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715212|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715213|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
716674|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715214|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715215|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715216|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715217|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715218|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715219|NCT01764022|O2|Outcome|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715220|NCT01764022|O1|Outcome|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715221|NCT01764022|E2|Reported Event|Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland)|In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715222|NCT01764022|E1|Reported Event|BCD-022 (CJSC BIOCAD)|BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations).
715223|NCT01763996|B1|Baseline|All Participants|All participants who were randomized and received study drug (febuxostat 80 mg and placebo) during the study.
715224|NCT01763996|P2|Participant Flow|Sequence 2: Placebo + Febuxostat 80 mg|Febuxostat placebo-matching capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 2.
715225|NCT01763996|P1|Participant Flow|Sequence 1: Febuxostat 80 mg + Placebo|Febuxostat 80 mg, capsules, orally, once daily for 6 weeks in Period 1, followed by febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 2.
715226|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715236|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715237|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715238|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715239|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715240|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715241|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715242|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715243|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715244|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715245|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715246|NCT01763996|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715247|NCT01763996|O1|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715248|NCT01763996|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715249|NCT01763996|E1|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 6 weeks in Period 1 or 2.
715250|NCT01763918|B5|Baseline|Total|Total of all reporting groups
715251|NCT01763918|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715252|NCT01763918|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715253|NCT01763918|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715260|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715261|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715262|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715263|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715264|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715265|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715266|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715267|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715268|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715269|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715270|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715271|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715272|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715273|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715274|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715275|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715276|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715277|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715278|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715279|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715280|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715281|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715282|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715283|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716696|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715284|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715285|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715286|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715287|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715288|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715289|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715290|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715291|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715292|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715293|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715294|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715295|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715296|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715297|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715298|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715299|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715300|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715301|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715302|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715303|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715304|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715305|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715306|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715307|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715308|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715309|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715310|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715311|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715312|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715313|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715314|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715315|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715316|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715317|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715318|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715319|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715320|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715321|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715322|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715323|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715324|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715325|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715326|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715327|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715328|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715329|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715330|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715331|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715332|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715333|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715334|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715335|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715336|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715337|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715338|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715339|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715340|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715341|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715342|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715343|NCT01763918|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715344|NCT01763918|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715345|NCT01763918|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715346|NCT01763918|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715347|NCT01763918|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715348|NCT01763918|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715349|NCT01763918|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) for up to 12 weeks.
715350|NCT01763918|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for up to 12 weeks.
715351|NCT01763905|B5|Baseline|Total|Total of all reporting groups
715352|NCT01763905|B4|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715353|NCT01763905|B3|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715354|NCT01763905|B2|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715355|NCT01763905|B1|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715356|NCT01763905|P4|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715357|NCT01763905|P3|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715358|NCT01763905|P2|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715359|NCT01763905|P1|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715360|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715361|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715362|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715363|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715364|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715365|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715366|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715367|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715368|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715369|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715370|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715371|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715372|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716112|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
715373|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715374|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715375|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715376|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715377|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715378|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715379|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715380|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715381|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715382|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715383|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715384|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715385|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715386|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715387|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715388|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715389|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715390|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715391|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715392|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715393|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715394|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715395|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715396|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715397|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715398|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715399|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715400|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715401|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715402|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715403|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715404|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715405|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715406|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715407|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715408|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715409|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715410|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715411|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715412|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715413|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715414|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715415|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715416|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715417|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715418|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715419|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715420|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715421|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715422|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715423|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715424|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715425|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715426|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715427|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715428|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715429|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715430|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715431|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715432|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715433|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715434|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715435|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715436|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715437|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715438|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715439|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715440|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715441|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715442|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715443|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715444|NCT01763905|O4|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715445|NCT01763905|O3|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715446|NCT01763905|O2|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715447|NCT01763905|O1|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715448|NCT01763905|E4|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715449|NCT01763905|E3|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
715450|NCT01763905|E2|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
715451|NCT01763905|E1|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
715452|NCT01763866|B25|Baseline|Total|Total of all reporting groups
715453|NCT01763866|B24|Baseline|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715454|NCT01763866|B23|Baseline|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715455|NCT01763866|B22|Baseline|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715456|NCT01763866|B21|Baseline|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715457|NCT01763866|B20|Baseline|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715458|NCT01763866|B19|Baseline|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715459|NCT01763866|B18|Baseline|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715460|NCT01763866|B17|Baseline|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715461|NCT01763866|B16|Baseline|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715462|NCT01763866|B15|Baseline|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715463|NCT01763866|B14|Baseline|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715464|NCT01763866|B13|Baseline|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
716160|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
715465|NCT01763866|B12|Baseline|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715466|NCT01763866|B11|Baseline|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715467|NCT01763866|B10|Baseline|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715468|NCT01763866|B9|Baseline|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715469|NCT01763866|B8|Baseline|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715470|NCT01763866|B7|Baseline|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715471|NCT01763866|B6|Baseline|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715472|NCT01763866|B5|Baseline|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715473|NCT01763866|B4|Baseline|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715474|NCT01763866|B3|Baseline|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715475|NCT01763866|B2|Baseline|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715476|NCT01763866|B1|Baseline|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715477|NCT01763866|P24|Participant Flow|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715478|NCT01763866|P23|Participant Flow|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715479|NCT01763866|P22|Participant Flow|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715480|NCT01763866|P21|Participant Flow|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715481|NCT01763866|P20|Participant Flow|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715482|NCT01763866|P19|Participant Flow|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715483|NCT01763866|P18|Participant Flow|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715484|NCT01763866|P17|Participant Flow|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715485|NCT01763866|P16|Participant Flow|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715486|NCT01763866|P15|Participant Flow|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715487|NCT01763866|P14|Participant Flow|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715488|NCT01763866|P13|Participant Flow|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715489|NCT01763866|P12|Participant Flow|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715490|NCT01763866|P11|Participant Flow|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715491|NCT01763866|P10|Participant Flow|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
716675|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715492|NCT01763866|P9|Participant Flow|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715493|NCT01763866|P8|Participant Flow|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715494|NCT01763866|P7|Participant Flow|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715495|NCT01763866|P6|Participant Flow|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715496|NCT01763866|P5|Participant Flow|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715497|NCT01763866|P4|Participant Flow|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715498|NCT01763866|P3|Participant Flow|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715499|NCT01763866|P2|Participant Flow|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715500|NCT01763866|P1|Participant Flow|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715501|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715502|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715503|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715504|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715505|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715506|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
716072|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
715507|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715508|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715509|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715510|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715511|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715512|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715513|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715514|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715515|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715516|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715517|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715518|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715519|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715520|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715521|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715522|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715523|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715524|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715525|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715526|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715527|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715528|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715529|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715530|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715531|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715532|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715533|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715534|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
720687|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion SF-36 Scores
715535|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715536|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715537|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715538|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715539|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715540|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715541|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715542|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715543|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715544|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715545|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
724178|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
715546|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715547|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715548|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715549|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715550|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715551|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715552|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715553|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715554|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715555|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715556|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715557|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715558|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715559|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715560|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715561|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715562|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715563|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715564|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715565|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715566|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715567|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715568|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715569|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715570|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715571|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715572|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715573|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715574|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715575|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715576|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715577|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715578|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715579|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715580|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715581|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715582|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715583|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715584|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715585|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715586|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715587|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715588|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715589|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715590|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715591|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715592|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715593|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715594|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715595|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715596|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715597|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715598|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715599|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715600|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715601|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
724179|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
715602|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715603|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715604|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715605|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715606|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715607|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715608|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715609|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715610|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715611|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715612|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715613|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715614|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715615|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715616|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715617|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715646|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715618|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715619|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715620|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715621|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715622|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715623|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715624|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715625|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715626|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715627|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715628|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715629|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715630|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715631|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715632|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715633|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715634|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715635|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715636|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715637|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715638|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715639|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715640|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715641|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715642|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715643|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715644|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715645|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715647|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715648|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715649|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715650|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715651|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715652|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715653|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715654|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715655|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715656|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715657|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715658|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715659|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715660|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715661|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715662|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715663|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715664|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715665|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715666|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715667|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715668|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715669|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715670|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715671|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715672|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715673|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715674|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
721164|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
715675|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715676|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715677|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715678|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715679|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715680|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715681|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715682|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715683|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715684|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
716676|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715685|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715686|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715687|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715688|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715689|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715690|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715691|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715692|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715693|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715694|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715695|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715696|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715697|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715698|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715699|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715700|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715701|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715702|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
721165|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
715703|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715704|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715705|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715706|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715707|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715708|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715709|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715710|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715711|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716677|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715712|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715713|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715714|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715715|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715716|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715717|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715718|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715719|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715720|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715721|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715722|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715723|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715724|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715725|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715726|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715727|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715728|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715729|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715730|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715731|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715732|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715733|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715734|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715735|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715736|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715737|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715738|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715767|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715739|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715740|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715741|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715742|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715743|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715744|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715745|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715746|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715747|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715748|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715749|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715750|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715751|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715752|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715753|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715754|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715755|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715756|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715757|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715758|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715759|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715760|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715761|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715762|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715763|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715764|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715765|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715766|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715768|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715769|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715770|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715771|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715772|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715773|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715774|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715775|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715776|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715777|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715778|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715779|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715780|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715781|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715782|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715783|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715784|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715785|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715814|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715786|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715787|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715788|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715789|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715790|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715791|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715792|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715793|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715794|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715795|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715796|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715797|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715798|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715799|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715800|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715801|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715802|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715803|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715804|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715805|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715806|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715807|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715808|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715809|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715810|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715811|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715812|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715813|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715815|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715816|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715817|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715818|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715819|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715820|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715821|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715822|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715823|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
724180|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
715824|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715825|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715826|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715827|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715828|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715829|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715830|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715831|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715832|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715833|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715834|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715835|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715836|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715837|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715838|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715839|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715840|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715841|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715842|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
721166|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
715843|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715844|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715845|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715846|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715847|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715848|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715849|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715850|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716678|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715851|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715852|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715853|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715854|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715855|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715856|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715857|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715858|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715859|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715860|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715861|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715862|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715863|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715864|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715865|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715866|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715867|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715868|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715869|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715870|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
721167|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
715871|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715872|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715873|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715874|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715875|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715876|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715877|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716679|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
715878|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715879|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715880|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715881|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715882|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715883|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715884|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715885|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715886|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715887|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715888|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715889|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715890|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715891|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715892|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715893|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715894|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715895|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715896|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715897|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715898|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715899|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715900|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715901|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715902|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715903|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715904|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715933|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715905|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715906|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715907|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715908|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715909|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715910|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715911|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715912|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715913|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715914|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715915|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715916|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715917|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715918|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715919|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715920|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715921|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715922|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715923|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715924|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715925|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715926|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715927|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715928|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715929|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715930|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715931|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715932|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715934|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715935|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715936|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715937|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715938|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715939|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715940|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715941|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715942|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715943|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715944|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715945|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715946|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715947|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715948|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715949|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715950|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715951|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715952|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715953|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715982|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715954|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715955|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715956|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715957|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715958|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715959|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715960|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715961|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715962|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715963|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715964|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715965|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715966|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715967|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715968|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715969|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715970|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715971|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715972|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715973|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715974|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715975|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715976|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715977|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715978|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
715979|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
715980|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
715981|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715983|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715984|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715985|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
715986|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715987|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715988|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715989|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
724181|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
715990|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
715991|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
715992|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
715993|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715994|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715995|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
715996|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
715997|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
715998|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
715999|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716000|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716001|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
716002|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
716003|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
716004|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
716005|NCT01763866|O24|Outcome|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716006|NCT01763866|O23|Outcome|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
716007|NCT01763866|O22|Outcome|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
716008|NCT01763866|O21|Outcome|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
716009|NCT01763866|O20|Outcome|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716010|NCT01763866|O19|Outcome|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
721168|NCT01733732|E2|Reported Event|Systane Gel|One drop in each eye 4 times a day for 30 days
716011|NCT01763866|O18|Outcome|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
716012|NCT01763866|O17|Outcome|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
716013|NCT01763866|O16|Outcome|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716014|NCT01763866|O15|Outcome|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
716015|NCT01763866|O14|Outcome|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
716016|NCT01763866|O13|Outcome|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
716080|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716017|NCT01763866|O12|Outcome|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716018|NCT01763866|O11|Outcome|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716019|NCT01763866|O10|Outcome|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
716020|NCT01763866|O9|Outcome|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
716021|NCT01763866|O8|Outcome|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716022|NCT01763866|O7|Outcome|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716023|NCT01763866|O6|Outcome|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716024|NCT01763866|O5|Outcome|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716025|NCT01763866|O4|Outcome|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
716026|NCT01763866|O3|Outcome|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
716027|NCT01763866|O2|Outcome|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
716028|NCT01763866|O1|Outcome|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
716029|NCT01763866|E24|Reported Event|S40 EvoMab QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716030|NCT01763866|E23|Reported Event|S40 EvoMab Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
716031|NCT01763866|E22|Reported Event|S40 PBO QM|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
716032|NCT01763866|E21|Reported Event|S40 PBO Q2W|Participants received simvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
716033|NCT01763866|E20|Reported Event|R40 EvoMab QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716034|NCT01763866|E19|Reported Event|R40 EvoMab Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
716035|NCT01763866|E18|Reported Event|R40 PBO QM|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
716036|NCT01763866|E17|Reported Event|R40 PBO Q2W|Participants received rosuvastatin 40 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
716037|NCT01763866|E16|Reported Event|R5 EvoMab QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month for up to 12 weeks.
716038|NCT01763866|E15|Reported Event|R5 EvoMab Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks for up to 12 weeks.
716039|NCT01763866|E14|Reported Event|R5 PBO QM|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month for up to 12 weeks.
716040|NCT01763866|E13|Reported Event|R5 PBO Q2W|Participants received rosuvastatin 5 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks for up to 12 weeks.
716041|NCT01763866|E12|Reported Event|A80 EvoMab QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716042|NCT01763866|E11|Reported Event|A80 EvoMab Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716043|NCT01763866|E10|Reported Event|A80 EZE (QM)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
716680|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716044|NCT01763866|E9|Reported Event|A80 EZE (Q2W)|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once daily for up to 12 weeks.
716045|NCT01763866|E8|Reported Event|A80 PBO QM|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716046|NCT01763866|E7|Reported Event|A80 PBO Q2W|Participants received atorvastatin 80 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716047|NCT01763866|E6|Reported Event|A10 EvoMab QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once daily for up to 12 weeks.
716048|NCT01763866|E5|Reported Event|A10 EvoMab Q2W|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with 140 mg evolocumab (EvoMab) by subcutaneous injection once every 2 weeks and placebo tablets once daily for up to 12 weeks.
716049|NCT01763866|E4|Reported Event|A10 EZE (QM)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month and 10 mg ezetimibe orally once daily for up to 12 weeks.
716050|NCT01763866|E3|Reported Event|A10 EZE (Q2W)|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe (EZE) orally once daily for up to 12 weeks.
716051|NCT01763866|E2|Reported Event|A10 PBO QM|Participants received atorvastatin 10 mg a day during the 4-week lipid stabilization period and then in combination with placebo subcutaneous injection once a month (QM) and placebo tablets once daily for up to 12 weeks.
716052|NCT01763866|E1|Reported Event|A10 PBO Q2W|Participants received atorvastatin 10 mg once daily during the 4 week lipid stabilization period and then in combination with placebo (PBO) subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once daily for up to 12 weeks.
716053|NCT01763827|B7|Baseline|Total|Total of all reporting groups
716054|NCT01763827|B6|Baseline|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716055|NCT01763827|B5|Baseline|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716056|NCT01763827|B4|Baseline|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716057|NCT01763827|B3|Baseline|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716058|NCT01763827|B2|Baseline|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716059|NCT01763827|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716060|NCT01763827|P6|Participant Flow|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716061|NCT01763827|P5|Participant Flow|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716062|NCT01763827|P4|Participant Flow|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716063|NCT01763827|P3|Participant Flow|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716064|NCT01763827|P2|Participant Flow|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716065|NCT01763827|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716066|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716067|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716068|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716069|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716070|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716071|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716073|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716074|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716075|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716076|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716077|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716078|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716079|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716081|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716082|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716083|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716084|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716085|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716086|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716087|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716088|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716089|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716090|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716091|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716092|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716093|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716094|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716095|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716096|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716097|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716098|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716099|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716100|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716101|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716102|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716103|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716104|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716105|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716106|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716107|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716108|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716109|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716110|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716111|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
721169|NCT01733732|E1|Reported Event|Systane Balance|One drop in each eye 4 times a day for 30 days
716113|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716114|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716115|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716116|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716117|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716118|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716119|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716120|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716121|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716122|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716123|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716124|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716125|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716126|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716127|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716128|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716129|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716130|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716131|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716132|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716133|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716134|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716135|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716136|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716137|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716138|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716139|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716140|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716141|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716142|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716143|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716144|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716145|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716146|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716147|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716148|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716149|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716150|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716151|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
722870|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
716152|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716153|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716154|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716155|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716156|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716157|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716158|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716159|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716161|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716162|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716163|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716164|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716165|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716166|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716167|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716168|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716169|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716170|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716171|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716172|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716173|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716174|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716175|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716176|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716177|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716178|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716179|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716180|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716181|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716182|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716183|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716184|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716185|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716186|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716187|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716188|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716189|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716190|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716697|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716191|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716192|NCT01763827|O6|Outcome|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716193|NCT01763827|O5|Outcome|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716194|NCT01763827|O4|Outcome|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716195|NCT01763827|O3|Outcome|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716196|NCT01763827|O2|Outcome|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716197|NCT01763827|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716198|NCT01763827|E6|Reported Event|Evolocumab QM|Participants received 420 mg evolocumab by subcutaneous injection once a month and placebo tablets once a day for up to 12 weeks.
716681|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716199|NCT01763827|E5|Reported Event|Evolocumab Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks and placebo tablets once a day for up to 12 weeks.
716200|NCT01763827|E4|Reported Event|Ezetimibe (QM)|Participants received placebo subcutaneous injection once a month and 10 mg ezetimibe orally once a day for up to 12 weeks.
716201|NCT01763827|E3|Reported Event|Ezetimibe (Q2W)|Participants received placebo subcutaneous injection once every 2 weeks and 10 mg ezetimibe orally once a day for up to 12 weeks.
716202|NCT01763827|E2|Reported Event|Placebo QM|Participants received placebo subcutaneous injection once every month (QM) and placebo tablets once a day for up to 12 weeks.
716203|NCT01763827|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) and placebo tablets once a day for up to 12 weeks.
716204|NCT01763645|B3|Baseline|Total|Total of all reporting groups
716205|NCT01763645|B2|Baseline|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
716206|NCT01763645|B1|Baseline|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716207|NCT01763645|P2|Participant Flow|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716208|NCT01763645|P1|Participant Flow|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716209|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716210|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716211|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716212|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716213|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716236|NCT01763047|P2|Participant Flow|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B lens and then received the etafilcon A lens.
716429|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716214|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716215|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716216|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716217|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716218|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716219|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1. Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716220|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716221|NCT01763645|O2|Outcome|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel.~Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1."
716222|NCT01763645|O1|Outcome|BCD-021 (CISC BIOCAD)|In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.
716223|NCT01763645|E2|Reported Event|Avastin (F. Hoffmann-La Roche Ltd)|"In this arm patients received 6 courses of treatment with Avastin in combination with carboplatin and paclitaxel. Avastin was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks on Day 1.~Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
716224|NCT01763645|E1|Reported Event|BCD-021 (CISC BIOCAD)|"In this arm patients received 6 courses of treatment with BCD-021 in combination with carboplatin and paclitaxel. BCD-021 was administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each course). Paclitaxel was administered at a dose of 175 mg/m2 as 3 hour intravenous infusion every 3 weeks on Day 1 and carboplatin (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel every 3 weeks on Day 1.~Data on adverse events was collected from date of signing informed consent up to 18 weeks after first injection of study drug."
716225|NCT01763567|B1|Baseline|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716226|NCT01763567|P1|Participant Flow|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716227|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716228|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716229|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716230|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716231|NCT01763567|O1|Outcome|Oberservation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716232|NCT01763567|E1|Reported Event|Observation Arm|To assess safety and device performance for the Hospital Glucose Managment system
716233|NCT01763047|B3|Baseline|Total|Total of all reporting groups
716234|NCT01763047|B2|Baseline|Lotrafilcon B/ Etafilcon A|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the lotrafilcon B and then received the etafilcon A.
716235|NCT01763047|B1|Baseline|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A and then received the lotrafilcon B.
722872|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
716237|NCT01763047|P1|Participant Flow|Etafilcon A/ Lotrafilcon B|Subjects were randomly assigned to one of two possible lens sequences. Subjects first received the etafilcon A lens and then received the lotrafilcon B lens.
716238|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
716239|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
716240|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
716241|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
716242|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
716243|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
716244|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
716245|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A during either the first or second period of the study. Subjects were then stratified by sphere power as either Hyperopes or Myopes.
716246|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B during either the first or second period of the study.
716247|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
716248|NCT01763047|O2|Outcome|Lotrafilcon B|Subjects that were dispensed the lotrafilcon B lens during either the first or second period of the study.
716249|NCT01763047|O1|Outcome|Etafilcon A|Subjects that were dispensed the etafilcon A lens during either the first or second period of the study.
716250|NCT01763047|E2|Reported Event|Control (Lotrafilcon B)|Subjects that were dispensed the Control lens (lotrafilcon B) during either the first or second period of the study.
716251|NCT01763047|E1|Reported Event|Test (Etafilcon A)|Subjects that were dispensed the Test lens (etafilcon A) during either the first or second period of the study.
716252|NCT01762982|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
716253|NCT01762982|P1|Participant Flow|Overall|This was a 4-way split-plot clinical study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 milliliters (mL) of 0.13% Benazalkonium chloride solution), one positive control [Sodium lauryl sulphate (SLS); 0.03 mL of 0.3% weight by weight (w/w) SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% weight by volume (w/v) normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.
716254|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716255|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716256|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716257|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716258|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
716259|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716260|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716261|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716262|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
716263|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716264|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716265|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716266|NCT01762982|O2|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716267|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716268|NCT01762982|O4|Outcome|Empty Finn Chamber|Empty Finn Chamber (a patch test device) was applied to upper back of participants for 24 hours.
716269|NCT01762982|O3|Outcome|Normal Saline Water|0.03 mL of 0.9% w/v normal saline, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716270|NCT01762982|O2|Outcome|SLS Solution|0.03 mL of 0.3% w/w SLS solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716271|NCT01762982|O1|Outcome|Benzalkonium Chloride Solution|0.03 mL of 0.13% Benazalkonium chloride solution, filled in a Finn chamber was applied to upper back of participants for 24 hours.
716282|NCT01762800|B1|Baseline|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716430|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716272|NCT01762982|E1|Reported Event|Overall Study|"This was a 4-way split-plot study. Four Finn chambers which contained the test product (Benzalkonium chloride solution; 0.03 mL of 0.13% Benazalkonium chloride solution), one positive control [SLS; 0.03 mL of 0.3% w/w SLS solution] and 2 negative controls including one chamber for normal saline (0.03 mL of 0.9% w/v normal saline) and an empty Finn chamber were applied on the left upper back of each subject for 24 hours under occlusive dressing. The sequence of the patch assembly (Finn chambers) was randomized. During this 24 hour patch applications, subjects had direct and ongoing skin contact with the investigational products and the positive and negative controls.~All randomized participants exposed to at least one of the study treatments were evaluated for safety."
716285|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716479|NCT01761162|B1|Baseline|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716273|NCT01762904|B1|Baseline|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
716274|NCT01762904|P1|Participant Flow|Whole Group of 135 Units of Measurement|"The arm is composed of 135 units of measurement, it means, 540 determinations to test 2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol and two controls.~The principal unit of measurement it will be four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites, and determination as to each separately sampling for each area for each antiseptic forearm. The same subject may be assessed up to three separate occasions provided only after a minimum period of two weeks between each determination.~Interventions:~Biological: Bacterial culture of the prepared skin's areas with two antiseptics and two controls~Other: Preparing skin's areas to be tested with two antiseptics and two controls"
716275|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
716276|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test two controls: Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. Deionized water redistilled and Scrub the skin without prior application of any substance was tested.~Were prepared two skin's areas of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
716277|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 1% triclosan in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 1% triclosan in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
716278|NCT01762904|O1|Outcome|Whole Group of 135 Units of Measurement|"135 determinations to test 2% chlorhexidine in 70% isopropyl alcohol.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol was tested. Were prepared the skin area of 25 cm2 randomly selected. The solution remained on the skin for 60s, 3h and 24h, everyone on different days.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
716279|NCT01762904|E1|Reported Event|Whole Group of 135 Units of Measurement|"135 units of measurement to test two antiseptics and two controls. Principal unit of measurement: four determinations of bacterial counts in a subject for antiseptics and controls to test each of the application sites.~All volunteers was provided with a neutral soap without antiseptics for use of two weeks. 2% chlorhexidine in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol, Deionized water redistilled and Scrub the skin without prior application of any substance was tested. Were prepared four skin's areas of 25 cm2, two in each forearm. The solution remained on the skin for 60s, 3h and 24h.~Cultures was taken with a scrub-cup of 5 cm2 pressed over the skin, added a 3 mL of culture broth. The skin was scrub with a sterile rubber policeman for 1 minute and the procedure conducted once again. Both aliquots came together in a sterile tube, a sample of 50 microliters were spread in a plate containing a neutralizing agar and were incubated at 35°C for 24 h."
716280|NCT01762800|B3|Baseline|Total|Total of all reporting groups
716281|NCT01762800|B2|Baseline|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716431|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716283|NCT01762800|P2|Participant Flow|SAL/FLU 50/250 µg BID|Participants received 50/250 µg salmeterol xinafoate (SAL)/fluticasone propionate (FLU) BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716284|NCT01762800|P1|Participant Flow|TIO 18 µg QD|Participants received 18 micrograms (µg) tiotropium bromide (TIO) once daily (QD) via HandiHaler inhaler and placebo twice daily (BID) via dry powder inhaler (DPI), during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716286|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716287|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716288|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716289|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716290|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716291|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716292|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716293|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716294|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716295|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716296|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716297|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716298|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716299|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716300|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716301|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716302|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716319|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716303|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716304|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716305|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716306|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716307|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716308|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716309|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716310|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716311|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716312|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716313|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716314|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716315|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716316|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716317|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716318|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716463|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|
716320|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716321|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716322|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716323|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716324|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716325|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716326|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716327|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716328|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716329|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716330|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716331|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716332|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716333|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716334|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716335|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716464|NCT01761565|E2|Reported Event|40 Consecutive Doses of SUF NT 15 mcg|
716465|NCT01761565|E1|Reported Event|Single Dose of SUF NT 15 mcg|
716336|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716337|NCT01762800|O4|Outcome|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716338|NCT01762800|O3|Outcome|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716339|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716340|NCT01762800|O1|Outcome|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716341|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716342|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716343|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716344|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716345|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716346|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716347|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716348|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716349|NCT01762800|O2|Outcome|SAL/FLU 50/250 µg BID|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
716350|NCT01762800|O1|Outcome|TIO 18 µg QD|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study.
722916|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
716351|NCT01762800|E4|Reported Event|SAL/FLU 50/250 µg BID-TRIPLE|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of SAL/FLU 50/250 µg BID to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716352|NCT01762800|E3|Reported Event|SAL/FLU 50/250 µg BID-Single|Participants received 50/250 µg SAL/FLU BID via DPI and placebo QD via HandiHaler inhaler, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of SAL/FLU 50/250 µg BID were included in this arm.
716353|NCT01762800|E2|Reported Event|TIO 18 µg QD-TRIPLE|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who switched from the single treatment of TIO 18 µg QD to TRIPLE therapy (SAL/FLU 50/250 µg BID+TIO 18 µg QD) were included in this arm.
716466|NCT01761279|B1|Baseline|HDWL + I-Scan|High Definition White Light Endoscopy and i-Scan assessment performed of all polyps
716354|NCT01762800|E1|Reported Event|TIO 18 µg QD-Single|Participants received 18 µg TIO QD via HandiHaler inhaler and placebo BID via DPI, during the 24-week study treatment period. Participants also received 400 µg salbutamol as relief medication and as a bronchodilator for pulmonary function testing as required throughout the study. Participants who remained on the single treatment of TIO 18 µg QD were included in this arm.
716432|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716428|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716410|NCT01762722|B3|Baseline|Total|Total of all reporting groups
716411|NCT01762722|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
716412|NCT01762722|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
716413|NCT01762722|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
716414|NCT01762722|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
716415|NCT01762722|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
716416|NCT01762722|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
716417|NCT01762722|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
716418|NCT01762722|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
716419|NCT01762501|B3|Baseline|Total|Total of all reporting groups
716420|NCT01762501|B2|Baseline|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716421|NCT01762501|B1|Baseline|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716422|NCT01762501|P2|Participant Flow|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716423|NCT01762501|P1|Participant Flow|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716424|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716425|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716426|NCT01762501|O2|Outcome|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716427|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716519|NCT01760889|B4|Baseline|Total|Total of all reporting groups
716433|NCT01762501|O1|Outcome|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716434|NCT01762501|E2|Reported Event|Amlodipine|"Amlodipine 5mg/day in oral administration, single dose Treatment duration: 8 weeks~Amlodipine: Amlodipine 5mg/day"
716435|NCT01762501|E1|Reported Event|Azilsartan|"Azilsartan 20mg/day in oral administration, single dose Treatment duration: 8 weeks~Azilsartan: Azilsartan 20mg/day"
716436|NCT01762345|B1|Baseline|Pessary Device|pessary (disposable intra-vaginal device)
716437|NCT01762345|P1|Participant Flow|Pessary Device|pessary (disposable intra-vaginal device)
716438|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
716439|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
716440|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
716441|NCT01762345|O1|Outcome|Pessary Device|"pessary (disposable intra-vaginal device)~pessary (disposable intra-vaginal device): pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble"
716442|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
716443|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
716444|NCT01762345|O1|Outcome|Pessary Device|pessary (disposable intra-vaginal device)
716445|NCT01762345|E1|Reported Event|Pessary Device|pessary (disposable intra-vaginal device)
716446|NCT01761747|B1|Baseline|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716447|NCT01761747|P1|Participant Flow|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716448|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716449|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716450|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716451|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716452|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716453|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716454|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716455|NCT01761747|O1|Outcome|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716456|NCT01761747|E1|Reported Event|Ponatinib Treatment Arm|"Ponatinib taken by mouth daily~ponatinib"
716457|NCT01761565|B1|Baseline|One Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15 mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Single dose of SUF NT 15 mcg~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~40 consecutive doses of SUF NT 15 mcg"
716458|NCT01761565|P1|Participant Flow|Single Dose of SUF NT 15 mcg Then 40 Doses of SUF NT 15mcg|"Arm 1/Period 1: Single dose of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 14 and 2 hours before and 10 hours after the SUF NT dosing~Arm 2/Period 2: 40 consecutive doses of SUF NT 15 mcg~Subjects received oral naltrexone 50 mg approximately 2 hours before and 10, 22, and 34 hours after the first dose of SUF NT in Period 2."
716459|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
716460|NCT01761565|O1|Outcome|Single Dose of SUF NT 15 mcg|Arm 1/Period 1: Single dose of SUF NT 15 mcg
716461|NCT01761565|O1|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
716462|NCT01761565|O2|Outcome|40 Consecutive Doses of SUF NT 15 mcg|
716480|NCT01761162|P1|Participant Flow|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716481|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716482|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716483|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716484|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716520|NCT01760889|B3|Baseline|Placebo|Placebo: One capsule a day for 26 weeks
716485|NCT01761162|O1|Outcome|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716486|NCT01761162|E1|Reported Event|Pacemaker Therapy|"Patients with a ProMRI Pacemaker System~Patients with a ProMRI Pacemaker System: Bradycardia Slow Heart Beat~Magnetic Resonance Imaging (MRI) scan: MRI scan of head and lower back."
716487|NCT01761019|B1|Baseline|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716488|NCT01761019|P1|Participant Flow|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716489|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716490|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716491|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716492|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716493|NCT01761019|O1|Outcome|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716494|NCT01761019|E1|Reported Event|Taclonex Topical Suspension|"Taclonex topical suspension will be used daily to affected areas of skin with psoriasis for 12 weeks~Taclonex Topical Suspension: topical medication for psoriasis"
716495|NCT01760993|B1|Baseline|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716496|NCT01760993|P1|Participant Flow|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716497|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716498|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716499|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716500|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716501|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716502|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716503|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716504|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716505|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716506|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716507|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716508|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716509|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716510|NCT01760993|O1|Outcome|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716511|NCT01760993|E1|Reported Event|SPD489|SPD489: Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
716512|NCT01760941|B1|Baseline|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
716513|NCT01760941|P1|Participant Flow|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
716682|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
724182|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
716514|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
716515|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
716516|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
716517|NCT01760941|O1|Outcome|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
716518|NCT01760941|E1|Reported Event|Radiotherapy|"Single fraction radiotherapy~Radiotherapy: Single fraction radiotherapy. All study participants will be evaluated, simulated, and treated with conventional single fraction palliative radiotherapy using standard techniques with CT-based treatment.~planning."
716521|NCT01760889|B2|Baseline|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716522|NCT01760889|B1|Baseline|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716523|NCT01760889|P3|Participant Flow|Placebo|Placebo: One capsule a day for 26 weeks
716524|NCT01760889|P2|Participant Flow|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716525|NCT01760889|P1|Participant Flow|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716526|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716527|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716528|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716529|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716530|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716531|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716532|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716533|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716534|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716535|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716555|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716536|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716537|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716538|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716539|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716644|NCT01759368|O2|Outcome|Control Group|Control group received usual care
716698|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716699|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716540|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716541|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716542|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716543|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716544|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716545|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716546|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716547|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716548|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716549|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716550|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716551|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716552|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716553|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716554|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716557|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716558|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716559|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716688|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716689|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716560|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716561|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716562|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716563|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716564|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716565|NCT01760889|O3|Outcome|Placebo|Placebo: One capsule a day for 26 weeks
716566|NCT01760889|O2|Outcome|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716567|NCT01760889|O1|Outcome|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716568|NCT01760889|E3|Reported Event|Placebo|Placebo: One capsule a day for 26 weeks
716569|NCT01760889|E2|Reported Event|SPD489 High Dose Range|"SPD489 high dose range (120mg, 140mg and 160mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once daily for 1 week; then~120 mg capsule once-daily for 1 week, then,~140 mg capsule once-daily for 2 weeks, then~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
716570|NCT01760889|E1|Reported Event|SPD489 Low Dose Range|"SPD489 low dose range (40mg, 80mg, and 100mg): Capsule, dose titration,~40 mg capsule once-daily for 1 week; then~80 mg capsule once-daily for 4 weeks; then,~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
716571|NCT01760876|B1|Baseline|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
716572|NCT01760876|P1|Participant Flow|Biofreedom Stent|Coronary intervention: The BioFreedom drug coated study stent (DCS) is a polymer-free biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
716573|NCT01760876|O1|Outcome|Biofreedom Stent|The healing profile (curve) in terms of percentage strut coverage of the BioFreedom Stent increased from a median of 85.77%, 86.95%, 88.56%, 96.79%, and 97.14% in the first 5 months, to 99.55% at 9 months.
716574|NCT01760876|E1|Reported Event|Biofreedom Stent|The BioFreedom drug coated study stent (DCS) is a polymer-free abluminally coated Biolimus A9 coated drug stent. 100 patients needed to complete 3 OCT assessments over 9 months:- (1) at baseline (n = 100) for best stent optimization, (2) at 5 monthly groups (randomly assigned in 1 to 5 months n= 20:20:20:20:20) for early healing profile, and (3) at 9 months (n = 100) for neointima metrics.
716575|NCT01760785|B3|Baseline|Total|Total of all reporting groups
716683|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716576|NCT01760785|B2|Baseline|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
716577|NCT01760785|B1|Baseline|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
716578|NCT01760785|P2|Participant Flow|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
716579|NCT01760785|P1|Participant Flow|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
716580|NCT01760785|O2|Outcome|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
716581|NCT01760785|O1|Outcome|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
716582|NCT01760785|E2|Reported Event|Sugar Pill|Placebo: Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
716583|NCT01760785|E1|Reported Event|Divalproex Sodium|Divalproex sodium: Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
716584|NCT01760304|B3|Baseline|Total|Total of all reporting groups
716585|NCT01760304|B2|Baseline|Placebo First, Then Budesonide/Formoterol|"Subjects received in a blinded fashion placebo 2 inhalation then Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5)~Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Placebo on visit 1 then Budesonide/formoterol (B/F) 160/4.5 msg per activation on visit 2 (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716586|NCT01760304|B1|Baseline|Budesonide / Formoterol First , Then Placebo|"Subjects received in a blinded fashion Budesonide/Formoterol (Symbicort ® )2 inhalations (160/4.5) then placebo 2 inhalations Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716587|NCT01760304|P2|Participant Flow|Placebo Then Budesonide/Formoterol|"Every patient in this arm received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® )~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716588|NCT01760304|P1|Participant Flow|Budesonide / Formoterol , Then Placebo|"This is a crossover study, where every patient signed to this arm received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) 160/4.5 mcg (2 inhalations) then placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716589|NCT01760304|O2|Outcome|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716690|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716691|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716692|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716590|NCT01760304|O1|Outcome|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716591|NCT01760304|O2|Outcome|Placebo|"In this arm patients will received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study)~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716592|NCT01760304|O1|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716593|NCT01760304|O2|Outcome|Placebo|"In this arm patients received in a blinded fashion placebo first then Budesonide/Formoterol (Symbicort ® ) on subsequent visit (cross-over study).~Placebo: On visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716594|NCT01760304|O1|Outcome|Budesonide / Formoterol|"In this arm patients received in a blinded fashion Budesonide/Formoterol (Symbicort ® ) first then placebo on subsequent visit (cross-over study)~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716595|NCT01760304|E2|Reported Event|Placebo|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Placebo: Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716596|NCT01760304|E1|Reported Event|Budesonide / Formoterol|"This is a crossover study, where every patient will receive in a blinded fashion either Budesonide/Formoterol (Symbicort ® ) or placebo~Budesonide / Formoterol: Budesonide/ formoterol (B/F) 160/4.5 mcg per activation.~Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).~After 45 minutes , the above measurements will be repeated."
716597|NCT01759602|B1|Baseline|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716598|NCT01759602|P1|Participant Flow|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716599|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716600|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716684|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716685|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716601|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716602|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716603|NCT01759602|O1|Outcome|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716693|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716604|NCT01759602|E1|Reported Event|C1-esterase Inhibitor (Cinryze)|"This is a phase 1b open-label, interventional proof-of-concept study in patients with neuromyelitis optica (NMO) in which all subjects will receive 3 daily infusions of 2000 Units of intravenous CINRYZE at the onset of an NMO exacerbation in addition to standard of care high-dose steroids, plus an additional 2 infusions of 1000 Units of intravenous CINRYZE during a second treatment phase with plasma exchange, if necessary.~C1-esterase inhibitor (Cinryze)"
716605|NCT01759511|B1|Baseline|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716606|NCT01759511|P1|Participant Flow|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716607|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716608|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716609|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716610|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716611|NCT01759511|O1|Outcome|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716612|NCT01759511|E1|Reported Event|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
716613|NCT01759420|B1|Baseline|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
716614|NCT01759420|P1|Participant Flow|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
716615|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
716616|NCT01759420|O1|Outcome|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
716617|NCT01759420|E1|Reported Event|IV Ondansetron|"Adult emergency department patients receiving 4mg of IV ondansetron as part of their treatment plan.~Ondansetron: 4mg of intravenous ondansetron"
716618|NCT01759381|B3|Baseline|Total|Total of all reporting groups
716619|NCT01759381|B2|Baseline|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
716620|NCT01759381|B1|Baseline|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
716621|NCT01759381|P2|Participant Flow|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
716622|NCT01759381|P1|Participant Flow|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
716623|NCT01759381|O2|Outcome|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
716624|NCT01759381|O1|Outcome|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
716625|NCT01759381|E2|Reported Event|NPWT Arm Therapy|"This group will receive NPWT as opposed to the standard incisional dressing following complex spinal surgery.~Negative pressure wound therapy (NPWT)"
716626|NCT01759381|E1|Reported Event|No Negative Pressure Wound Therapy Device|This control group will not receive the negative pressure wound therapy device. Post operative dressings will be per the surgeon's standard routine.
716627|NCT01759368|B3|Baseline|Total|Total of all reporting groups
716686|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716687|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716700|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716701|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716628|NCT01759368|B2|Baseline|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients' visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient's own activity.
716629|NCT01759368|B1|Baseline|Telemonitoring-assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not mak
716630|NCT01759368|P2|Participant Flow|Control Group|Control group received multidisciplinary care that was standard.
716694|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716695|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716631|NCT01759368|P1|Participant Flow|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
716632|NCT01759368|O2|Outcome|Control Group|Control group received usual care
716633|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
716634|NCT01759368|O2|Outcome|Control Group|Control group received usual care that includes multidisciplinary care approach in which patients receive guidance and support for self-care. In the care of HF patients, the cardiac team plays a central role in monitoring and interpreting patient symptoms, optimizing medication and providing education. The cardiac team consists of two physicians, one specialized heart failure nurse and a physiotherapist who helps after a hospitalization period. As part of the care process, patients capable of carrying out self-care are identified and they are encouraged to regularly measure their blood pressure, heart rate and weight at home. So far, the information exchange between heart failure patients and care personnel has taken place during patients’ visits to the clinic and by telephone. Systematic collection and exploitation of the self-measurement data has been difficult, since it depends on the patient’s own activity
716635|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring.
716636|NCT01759368|O2|Outcome|Control Group|Control group received usual care
716637|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
716638|NCT01759368|O2|Outcome|Control Group|Control group received usual care
716702|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716703|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716704|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716639|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
716640|NCT01759368|O2|Outcome|Control Group|Control group received usual care
716641|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
716642|NCT01759368|O2|Outcome|Control Group|Control group received usual care
716643|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
716645|NCT01759368|O1|Outcome|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
716646|NCT01759368|E2|Reported Event|Control Group|Control group received usual care
716647|NCT01759368|E1|Reported Event|Telemonitoring Assisted Self-care|"Telemonitoring assisted self-care group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. A pre-installed software application in the mobile phone supported uploading of measurements and self-assessment of symptoms. The patients were advised to carry out and report the measurements together with the self-assessment once a week.~Telemonitoring assisted self-care: The responsible nurse followed patients’ status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring."
716648|NCT01759290|B1|Baseline|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716649|NCT01759290|P1|Participant Flow|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716650|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716651|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716652|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716653|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716654|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716655|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716656|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716657|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716658|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716659|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716660|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716661|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716662|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716663|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716664|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716665|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716666|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716667|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716668|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
724183|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
716705|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716706|NCT01759290|O1|Outcome|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716707|NCT01759290|E1|Reported Event|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
716708|NCT01759264|B1|Baseline|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716709|NCT01759264|P1|Participant Flow|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716710|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716711|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716712|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716713|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716714|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716715|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716716|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716717|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716718|NCT01759264|O2|Outcome|Moderate-to-severe Crohn's Disease (PP Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716719|NCT01759264|O1|Outcome|Moderate-to-severe Crohn's Disease (ITT Population)|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716720|NCT01759264|E1|Reported Event|Moderate-to-severe Crohn's Disease|Adalimumab induction therapy participants with moderate-to-severe Crohn's Disease
716721|NCT01759251|B1|Baseline|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
716722|NCT01759251|P1|Participant Flow|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
716723|NCT01759251|O1|Outcome|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
716724|NCT01759251|E1|Reported Event|Vestibular Vertigo|Patients with vestibular vertigo of known or unknown origin, and for whom the physician has decided to prescribe betahistine dihydrochloride at dose 48 mg/day in accordance with locally approved label
716725|NCT01759160|B3|Baseline|Total|Total of all reporting groups
716726|NCT01759160|B2|Baseline|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716727|NCT01759160|B1|Baseline|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716728|NCT01759160|P2|Participant Flow|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716729|NCT01759160|P1|Participant Flow|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716730|NCT01759160|O2|Outcome|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716731|NCT01759160|O1|Outcome|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716732|NCT01759160|E2|Reported Event|Schnider|Plasma TCI in Schnider Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716733|NCT01759160|E1|Reported Event|Marsh|Plasma TCI in Marsh Model with an initial target of 4 μg/ml, gradually titrated according to sedation level.
716734|NCT01758900|B3|Baseline|Total|Total of all reporting groups
716735|NCT01758900|B2|Baseline|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716736|NCT01758900|B1|Baseline|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716737|NCT01758900|P2|Participant Flow|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716738|NCT01758900|P1|Participant Flow|CO2(Carbon Dioxide) Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE(single-balloon enteroscopy)."
716739|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716740|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
724184|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
716741|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716742|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716743|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716744|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716745|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716746|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716747|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716748|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716749|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716750|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716751|NCT01758900|O2|Outcome|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716752|NCT01758900|O1|Outcome|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716753|NCT01758900|E2|Reported Event|Air Insufflation Regulator|"Room air will be used for insufflation as the Active Comparator arm~Air insufflation: The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716754|NCT01758900|E1|Reported Event|CO2 Insufflation Regulator|"Device: CO2 insufflation regulator~CO2 insufflation regulator: The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE."
716755|NCT01758289|B1|Baseline|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716756|NCT01758289|P1|Participant Flow|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol intravenous (IV) per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716757|NCT01758289|O2|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716758|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716759|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716760|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716813|NCT01757691|P1|Participant Flow|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
716761|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716762|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716763|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716764|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716765|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716766|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716767|NCT01758289|O3|Outcome|Paricalcitol IV: Week 24|Week 24 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716768|NCT01758289|O2|Outcome|Paricalcitol IV: Week 12|Week 12 Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716769|NCT01758289|O1|Outcome|Paricalcitol IV: Baseline|Baseline Visit: Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716770|NCT01758289|O1|Outcome|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716771|NCT01758289|E1|Reported Event|Paricalcitol IV|Participants with a diagnosis of chronic kidney disease stage V undergoing hemodialysis were treated with paricalcitol IV per routine clinical practice, according to prescribing information approved in Venezuela and clinical criteria.
716772|NCT01757964|B3|Baseline|Total|Total of all reporting groups
716773|NCT01757964|B2|Baseline|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
716774|NCT01757964|B1|Baseline|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
716775|NCT01757964|P2|Participant Flow|Bacteriotherapy: Ulcerative Colitis|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
716776|NCT01757964|P1|Participant Flow|Bacteriotherapy: Crohn's Disease|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
716777|NCT01757964|O1|Outcome|Bacteriotherapy|"Study stool recipient's will receive approximately 30 grams of processed donor stool through a tube into their stomach for the transplant.~Bacteriotherapy"
716814|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
716815|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
716816|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
722967|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
716826|NCT01757561|B4|Baseline|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716827|NCT01757561|B3|Baseline|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716828|NCT01757561|B2|Baseline|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
716829|NCT01757561|B1|Baseline|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
716778|NCT01757964|E1|Reported Event|Bacteriotherapy|Initial evaluation: Study subject recipient had laboratory tests Stool Transplantation: Study subject recipients received premedication prior to fecal transplant, which included rifaximin. Study subject recipients also receive Omeprazole (1mg/kg orally) on the day before and morning of procedure. Transplant recipient also MiraLAX for 2 days prior to FMT. For the FMT, a nasogastric (NG) tube was placed. Approximately 30g of donor stool was mixed with 100ml of normal saline and blenderized until a homogenous texture was achieved Post Transplantation follow-up: Study subject recipients were called 2 days after transplantation. Study subject recipients had clinical follow-up at 2 weeks, 6 weeks and 12 weeks. Standardized questionnaires, PUCAI, were completed during each study visit.
716779|NCT01757847|B3|Baseline|Total|Total of all reporting groups
716780|NCT01757847|B2|Baseline|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
716781|NCT01757847|B1|Baseline|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy
716782|NCT01757847|P2|Participant Flow|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
716783|NCT01757847|P1|Participant Flow|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
716784|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
716785|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
716786|NCT01757847|O2|Outcome|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
716787|NCT01757847|O1|Outcome|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
716788|NCT01757847|E2|Reported Event|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
716817|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
716818|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
716819|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
716789|NCT01757847|E1|Reported Event|Brief MOVE-II Active Control Group Intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol was delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition, the active control group focuses on increasing self-esteem and self-efficacy.
716790|NCT01757704|B3|Baseline|Total|Total of all reporting groups
716791|NCT01757704|B2|Baseline|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716792|NCT01757704|B1|Baseline|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716793|NCT01757704|P2|Participant Flow|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716794|NCT01757704|P1|Participant Flow|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716795|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716796|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716820|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
716821|NCT01757691|O2|Outcome|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
716822|NCT01757691|O1|Outcome|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
716797|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716798|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716799|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716800|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716801|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716802|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716803|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716823|NCT01757691|E2|Reported Event|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
716824|NCT01757691|E1|Reported Event|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
716825|NCT01757561|B5|Baseline|Total|Total of all reporting groups
716804|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716805|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716806|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716807|NCT01757704|O2|Outcome|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716808|NCT01757704|O1|Outcome|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716809|NCT01757704|E2|Reported Event|Open Pleurae & Conventional Filling of Heart|"In this group both pleurae will be opened and the ventilator disconnected during cardiopulmonary bypass to ensure bilateral lung collapse. However, after completion of the left heart procedure, the heart will be filled with blood actively from the heart-lung machine and manual de-airing performed in a conventional manner and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is complete and patient has been weaned off the cardiopulmonary bypass the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Open pleurae & conventional filling of heart : After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on trans-esophag"
716810|NCT01757704|E1|Reported Event|Intact Pleurae & Staged Filling of Heart|"In this group both pleurae will be left intact and the ventilator disconnected during cardiopulmonary bypass. After completion of the left heart surgery, the heart will be filled with blood actively from the heart-lung machine in a staged manner after adequate cardiac contraction has been established. De-airing will be obtained by active cardiac contraction and staged mechanical ventilation and de-airing monitored by intraoperative trans-esophageal echocardiography (TEE). After de-airing is deemed complete and patient has been weaned off the cardiopulmonary bypass (CPB) the residual air in the left heart will be quantitatively assessed by TEE and Trans-cranial Echo-Doppler (TCD) over a period of 10 minutes.~Intact pleurae & staged filling of heart : After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocar"
716811|NCT01757691|B1|Baseline|Fingolimod 0.5mg/Daily|Oral capsule dose was given once daily for 48 weeks
716812|NCT01757691|P2|Participant Flow|Placebo|Patients received oral dose of placebo from Weeks 0-18, followed by oral dose of fingolimod 0.5/mg capsule from Weeks 18-48
716830|NCT01757561|P4|Participant Flow|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716831|NCT01757561|P3|Participant Flow|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716832|NCT01757561|P2|Participant Flow|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
716833|NCT01757561|P1|Participant Flow|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
716834|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716835|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716836|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
716837|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
716838|NCT01757561|O4|Outcome|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716839|NCT01757561|O3|Outcome|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716840|NCT01757561|O2|Outcome|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
716841|NCT01757561|O1|Outcome|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
716842|NCT01757561|E4|Reported Event|Sevoflurane-Normal|"patients with preoperative SjvO2≥55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716843|NCT01757561|E3|Reported Event|Sevoflurane-Abnormal|"patients with preoperative SjvO2<55%~sevoflurane: use inhalation anesthesia with sevoflurane"
716844|NCT01757561|E2|Reported Event|Propofol-Normal|"patients with preoperative SjvO2≥55%~propofol: use total intravenous anesthesia with propofol"
716845|NCT01757561|E1|Reported Event|Propofol-Abnormal|"patients with preoperative SjvO2<55%~propofol: use total intravenous anesthesia with propofol"
716846|NCT01757405|B3|Baseline|Total|Total of all reporting groups
716847|NCT01757405|B2|Baseline|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716848|NCT01757405|B1|Baseline|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716849|NCT01757405|P2|Participant Flow|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716850|NCT01757405|P1|Participant Flow|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716851|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716852|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716853|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716854|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716855|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716856|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716857|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716858|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716859|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716860|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716861|NCT01757405|O2|Outcome|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716862|NCT01757405|O1|Outcome|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIaBI) every 3 hours as on-demand intravenous bolus infusions.
716863|NCT01757405|E2|Reported Event|Arm 2: 1 x 270 Micrograms/kg rFVIIa BI|Bleeding episodes treated with 1 dose of 270 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) as on-demand intravenous bolus infusion.
716864|NCT01757405|E1|Reported Event|Arm 1: up to 3 x 90 Micrograms/kg rFVIIa BI|Bleeding episodes treated with up to 3 doses of 90 micrograms/kg of recombinant activated factor VII BI (rFVIIa BI) every 3 hours as on-demand intravenous bolus infusions.
716865|NCT01757275|B3|Baseline|Total|Total of all reporting groups
716866|NCT01757275|B2|Baseline|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
724185|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
716867|NCT01757275|B1|Baseline|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716868|NCT01757275|P2|Participant Flow|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716869|NCT01757275|P1|Participant Flow|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716870|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716871|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716872|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716873|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716874|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716875|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716876|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716877|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716878|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716879|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716880|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716881|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716882|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716883|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716884|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716885|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716886|NCT01757275|O2|Outcome|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716887|NCT01757275|O1|Outcome|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716888|NCT01757275|E2|Reported Event|Cimetidine|Cimetidine iv 200 mg bolus infusion for 30 min followed by Cimetidine iv 60 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716889|NCT01757275|E1|Reported Event|Esomeprazole|Esomeprazole iv 80 mg bolus infusion for 30 min followed by Esomeprazole iv 8 mg/hour for 71.5 hours and esomeprazole oral 40 mg once daily for 27 days
716890|NCT01757184|B3|Baseline|Total|Total of all reporting groups
716891|NCT01757184|B2|Baseline|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716892|NCT01757184|B1|Baseline|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716893|NCT01757184|P2|Participant Flow|Double-Blind Placebo Followed by Open-Label SA|Double-blind Period: IV infusions of placebo administered once every other week (qow); Open-Label Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
716894|NCT01757184|P1|Participant Flow|Double-blind SA, Followed by Open-Label SA|Double-blind Period: IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow); Open-Label Period: IV infusions of SA at a dose of 1 mg/kg administered qow. In the event of disease progression (based on protocol-defined criteria), subjects could be considered for a dose increase to 3 mg/kg qow during the open-label period.
716895|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716896|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716897|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716898|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716899|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716900|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716901|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716902|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716903|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716904|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716905|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716906|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716907|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716908|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716909|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716910|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716911|NCT01757184|O2|Outcome|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716912|NCT01757184|O1|Outcome|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716913|NCT01757184|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo administered once every other week (qow)
716914|NCT01757184|E1|Reported Event|Double-Blind Sebelipase Alfa|IV infusions of sebelipase alfa (SA) at a dose of 1 mg/kg administered once every other week (qow)
716915|NCT01756976|B3|Baseline|Total|Total of all reporting groups
716916|NCT01756976|B2|Baseline|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
716917|NCT01756976|B1|Baseline|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
716918|NCT01756976|P2|Participant Flow|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
716919|NCT01756976|P1|Participant Flow|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
716920|NCT01756976|O2|Outcome|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
716921|NCT01756976|O1|Outcome|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
716922|NCT01756976|E2|Reported Event|Control Group|The commercially available OrthoPAT will be used in this arm. This is an observational trial and there is no intervention.
716923|NCT01756976|E1|Reported Event|Investigational Device|The 510k cleared OrthoPAT Advance will be used in this standard of care arm.
716924|NCT01756391|B1|Baseline|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
716925|NCT01756391|P1|Participant Flow|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
716926|NCT01756391|O1|Outcome|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
716927|NCT01756391|E1|Reported Event|Observational Cohort|students with asthma grades K-8 after the spring screening attending schools where permission for sampling obtained
716928|NCT01756300|B1|Baseline|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
716929|NCT01756300|P1|Participant Flow|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with severe resistant hypertension.
716930|NCT01756300|O4|Outcome|AT Twelve Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at Twelve month post-procedure
716931|NCT01756300|O3|Outcome|At Six Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at six month post-procedure
716932|NCT01756300|O2|Outcome|At Three Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at three month post-procedure
716933|NCT01756300|O1|Outcome|At One Month|Subjects achieved at least 10 mmHg systolic blood pressure reduction from Baseline at one month post-procedure
716934|NCT01756300|O4|Outcome|At Twelve Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at twelve month post-procedure
716935|NCT01756300|O3|Outcome|At Six Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at six month post-procedure
716936|NCT01756300|O2|Outcome|At Three Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at three month post-procedure
716937|NCT01756300|O1|Outcome|At One Month|Subjects achieved target systolic blood pressure, i.e., less than 140 mmHg, at one month post-procedure
716938|NCT01756300|O4|Outcome|Blood Pressures at 12-Month Follow Up|ABPM blood pressures measured at 12-month post procedure
716939|NCT01756300|O3|Outcome|Blood Pressures at 6-Month Follow Up|ABPM blood pressures measured at 6-month post procedure
716940|NCT01756300|O2|Outcome|Blood Pressures at 3-Month Follow Up|ABPM blood pressures measured at 3-month post procedure
716941|NCT01756300|O1|Outcome|Blood Pressures at Baseline|ABPM blood pressures measured at Baseline
716942|NCT01756300|O5|Outcome|Blood Pressures at 12-Month Follow Up|Office blood pressures measured at 12-month post procedure
716943|NCT01756300|O4|Outcome|Blood Pressures at 6-Month Follow Up|Office blood pressures measured at 6-month post procedure
716944|NCT01756300|O3|Outcome|Blood Pressures at 3-Month Follow Up|Office blood pressures measured at 3-month post procedure
716945|NCT01756300|O2|Outcome|Blood Pressures at 1-Month Follow Up|Office blood pressures measured at one month post-procedure
716946|NCT01756300|O1|Outcome|Blood Pressures at Baseline|Office blood pressures measured at Baseline
716947|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
716948|NCT01756300|O1|Outcome|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
716949|NCT01756300|E1|Reported Event|Renal Sympathetic Denervation|Subjects enrolled in this study underwent the renal sympathetic denervation procedure to treat resistant hypertension. The procedure used the investigational Celsius® ThermoCool® Renal Denervation Multi-electrode Ablation Catheter in subjects with resistant hypertension.
716950|NCT01756274|B1|Baseline|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples. Baseline Characteristics for Participant Flow based on number of blood samples, not number of subjects.
716951|NCT01756274|P1|Participant Flow|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS.
716952|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
716953|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
716954|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
716955|NCT01756274|O1|Outcome|Neonates 'Left-over' Blood Samples|Blood samples used in this study were 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory. Lab professionals tested the BG concentration using 3 Bayer Blood Glucose Monitoring Systems: Contour® NEXT, Contour® PLUS, and Contour® Next EZ BGMS. Each subject could contribute up to 2 blood samples.
716956|NCT01756274|E1|Reported Event|Neonates 'Left-over' Blood Samples|Blood samples used in this study are 'left-over samples' from heel sticks of neonates, collected (into a tube) and sent to the laboratory.
716957|NCT01756235|B1|Baseline|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716958|NCT01756235|P1|Participant Flow|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice
716959|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716960|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716961|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716962|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716963|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716964|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716965|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716966|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716967|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716968|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716969|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716970|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716971|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716972|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716973|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716974|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716975|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716976|NCT01756235|O1|Outcome|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716977|NCT01756235|E1|Reported Event|Participants With Rheumatoid Arthritis|Participants with rheumatoid arthritis treated with adalimumab in routine clinical practice.
716978|NCT01756157|B1|Baseline|Entire Study Population|Included participants who received 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment A) first and 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks (Treatment B) first.
718982|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
716979|NCT01756157|P2|Participant Flow|Treatment Sequence B/A|"Participants received Treatment B in Period 1 and Treatment A in Period 2; for 8 weeks each as a single 20 mL SC injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.~Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.~Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
716980|NCT01756157|P1|Participant Flow|Treatment Sequence A/B|"Participants received Treatment A in Period 1 and Treatment B in Period 2; for 8 weeks each as a single 20 milliliter (mL) subcutaneous (SC) injection per dose. A washout period of at least 7 days and no more than 30 days was maintained between the last dose in Period 1 and the first dose in Period 2.~Treatment A: 1000 U CINRYZE with 24,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks.~Treatment B: 2000 U CINRYZE with 48,000 U rHuPH20 twice weekly (every 3 or 4 days) for 8 weeks."
716981|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716982|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716983|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716984|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716985|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716986|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716987|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716988|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716989|NCT01756157|O2|Outcome|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716990|NCT01756157|O1|Outcome|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716991|NCT01756157|E2|Reported Event|Treatment B (2000 U CINRYZE + 48000 U rHuPH20)|Participants received Treatment B (2000 U CINRYZE with 48,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716992|NCT01756157|E1|Reported Event|Treatment A (1000 U CINRYZE + 24000 U rHuPH20)|Participants received Treatment A (1000 U CINRYZE with 24,000 U rHuPH20 twice weekly [every 3 or 4 days] for 8 weeks) as a single 20 mL SC injection per dose in each treatment period.
716993|NCT01756079|B1|Baseline|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
716994|NCT01756079|P1|Participant Flow|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
716995|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
716996|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day).
717024|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717025|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717026|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717027|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
716997|NCT01756079|O1|Outcome|Overall Participants|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
716998|NCT01756079|E1|Reported Event|Overall Participants: Lead-in, Treatment and Follow-up|Participants received PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) for 4 weeks during the Lead-in Period and then 44 additional weeks of treatment in the Treatment Period receiving PegIFN-2b (once weekly, 1.5 µg/kg subcutaneously) + RBV (capsules, orally, weight-based dose from 800-1400 mg/day divided into two daily doses) + boceprevir (capsules, orally, 800 mg three times per day). After completion of treatment, follow-up continued for an additional 24 weeks.
716999|NCT01756053|B1|Baseline|All Study Subjects|Subjects who were randomized and received their Period 1 study medication (ABT-089 or matching placebo).
717000|NCT01756053|P2|Participant Flow|Placebo, Then ABT-089|"Those randomized to placebo (matching ABT-089 10 mg capsules) during study medication period 1 will take four capsules daily during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four 10 mg capsules (40 mg) daily of ABT-089 for a second 10-day study medication period.~Placebo: Matching placebo capsules supplied by study drug supplier."
717001|NCT01756053|P1|Participant Flow|ABT-089, Then Placebo|"Those randomized to active ABT-089 during study medication period 1 will take four 10mg capsules daily (40mg daily) during a 10-day medication period. After a washout period of ~21 days, these subjects will then take four capsules of matching placebo daily for a second 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
717002|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717003|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717004|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717005|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717006|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717007|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717008|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717009|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717010|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717011|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717012|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717013|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717014|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717015|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717016|NCT01756053|O2|Outcome|Placebo|Subjects who were assigned to matched placebo (four capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717017|NCT01756053|O1|Outcome|ABT-089|Subjects who were assigned to active ABT-089 (four 10 mg capsules daily) in either Period 1 or Period 2 of the study. Each study period is 10 days.
717018|NCT01756053|E2|Reported Event|Placebo|"Subjects were assigned to take four placebo capsules (matching ABT-089 10 mg) daily during a 10-day medication period.~Placebo: Matched placebo capsules supplied by study drug supplier."
717019|NCT01756053|E1|Reported Event|ABT-089|"Subjects were assigned to take four 10 mg capsules daily (40 mg daily) during a 10-day medication period.~ABT-089: Selective neuronal nicotinic receptor agonist."
717020|NCT01755702|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
717021|NCT01755702|P1|Participant Flow|Overall|"In this cross-over study, participants were randomly-assigned to a blinded treatment sequence. Each participant was expected to complete 1, 2, or 3 periods depending on number of headache episodes.~The following treatments were administered during the study.~1000/130mg paracetamol/caffeine (two 500/65mg caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approximately (approx.) 250 ml of water.~1000mg paracetamol (two 500mg caplets) plus placebo paracetamol/caffeine (two caplets) taken orally with approx. 250 ml of water.~400mg ibuprofen (two 200mg caplets) plus placebo paracetamol/caffeine (two caplets) for a total of four caplets taken orally with approx. 250 ml of water.~placebo paracetamol/caffeine (two caplets) plus placebo ibuprofen (two caplets) for a total of four caplets taken orally with approx. 250 ml of water."
717022|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717023|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717230|NCT01754766|E1|Reported Event|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
717028|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717029|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717030|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717031|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717032|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717033|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717034|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717035|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717036|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717037|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717038|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717039|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717040|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717041|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717042|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717043|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717044|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717045|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717046|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717047|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717048|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717049|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717050|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717051|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717052|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717053|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717054|NCT01755702|O4|Outcome|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
717055|NCT01755702|O3|Outcome|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717056|NCT01755702|O2|Outcome|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717057|NCT01755702|O1|Outcome|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717058|NCT01755702|E4|Reported Event|Placebo|Participants were administered with four placebo caplets (two caplets matching paracetamol/caffeine and two caplets matching ibuprofen) orally with approx. 250 mL of water.
718263|NCT01748071|E2|Reported Event|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
717059|NCT01755702|E3|Reported Event|Paracetamol|Participants were administered with two 500 mg paracetamol caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717060|NCT01755702|E2|Reported Event|Ibuprofen|Participants were administered with two 200 mg Ibuprofen caplets and two placebo caplets (matching paracetamol/caffeine) orally with approx. 250 mL of water.
717061|NCT01755702|E1|Reported Event|Paracetamol/Caffeine|Participants were administered with two paracetamol/ caffeine caplets (500/65 mg each) and two placebo caplets (matching ibuprofen) orally with approx. 250 mL of water.
717062|NCT01755637|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
717063|NCT01755637|P2|Participant Flow|Albendazole (Alcohol) First, Then Albendazole (Aqua)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment followed by 400 mg aqua based albendazole tablets. A wash-out period of 7 days was maintained between treatment periods.
717064|NCT01755637|P1|Participant Flow|Albendazole (Aqua) First, Then Albendazole (Alcohol)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment, followed by single dose treatment of 400 mg albendazole tablets manufactured under ethanol based solvent conditions. A wash-out period of 7 days was maintained between treatment periods.
717065|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole Sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
717066|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole Sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
717067|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
717068|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
717069|NCT01755637|O2|Outcome|Reference: Albendazole Sulphoxide Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole sulphoxide tablets manufactured under ethanol based solvent condition as single dose treatment.
717070|NCT01755637|O1|Outcome|Experimental: Albendazole Sulphoxide Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole sulphoxide tablets manufactured under aqua based solvent condition as single dose treatment.
717071|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
717072|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
717073|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
717074|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
717075|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
717076|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
717077|NCT01755637|O2|Outcome|Reference: Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
717078|NCT01755637|O1|Outcome|Experimental: Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 milligram (mg) Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
717079|NCT01755637|E2|Reported Event|Albendazole Tablet (Alcohol Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under ethanol based solvent condition as single dose treatment.
717080|NCT01755637|E1|Reported Event|Albendazole Tablet (Aqua Based)|Participants were orally administered with 400 mg Albendazole tablets manufactured under aqua based solvent condition as single dose treatment.
717081|NCT01755455|B1|Baseline|All Study Participants|Includes those who started the study with First Intervention and those who started the study with Second Intervention
717082|NCT01755455|P2|Participant Flow|Ferrous Sulfate, Then Placebo|Ferrous Sulfate 325 mg administered daily for 6 weeks followed by 4-week washout, then Placebo administered daily for 6 weeks.
717083|NCT01755455|P1|Participant Flow|Placebo, Then Ferrous Sulfate|Placebo administered daily for 6 week followed by 4-week washout, then Ferrous Sulfate 325 mg administered daily for 6 weeks.
717084|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
717085|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
717086|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
717087|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
717088|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
717089|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
717090|NCT01755455|O2|Outcome|Ferrous Sulfate|Outcome measure in all participants who received ferrous sulfate.
717091|NCT01755455|O1|Outcome|Placebo|Outcome measure in all participants who received placebo.
717092|NCT01755455|E2|Reported Event|Ferrous Sulfate|Events observed among all participants while they were receiving ferrous sulfate.
717093|NCT01755455|E1|Reported Event|Placebo|Events observed among all participants while they were receiving placebo.
717094|NCT01755234|B3|Baseline|Total|Total of all reporting groups
717095|NCT01755234|B2|Baseline|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
717096|NCT01755234|B1|Baseline|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
717097|NCT01755234|P2|Participant Flow|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
717098|NCT01755234|P1|Participant Flow|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
717099|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
717100|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
717101|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
717102|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
717103|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
717104|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
717105|NCT01755234|O2|Outcome|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
717106|NCT01755234|O1|Outcome|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
717107|NCT01755234|E2|Reported Event|Propofol|"Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60~Propofol: Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60"
717108|NCT01755234|E1|Reported Event|Sevoflurane|"Sevoflurane administered by inhalation (laryngeal mask airway or endotracheal tube)~Sevoflurane: Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube"
717109|NCT01755169|B5|Baseline|Total|Total of all reporting groups
717110|NCT01755169|B4|Baseline|Placebo|Placebo
717111|NCT01755169|B3|Baseline|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717112|NCT01755169|B2|Baseline|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717113|NCT01755169|B1|Baseline|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717114|NCT01755169|P4|Participant Flow|Placebo|Placebo
717115|NCT01755169|P3|Participant Flow|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717116|NCT01755169|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717117|NCT01755169|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717118|NCT01755169|O4|Outcome|Placebo|Placebo
717119|NCT01755169|O3|Outcome|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717120|NCT01755169|O2|Outcome|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717121|NCT01755169|O1|Outcome|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717122|NCT01755169|E4|Reported Event|Placebo|Placebo
718264|NCT01748071|E1|Reported Event|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
717123|NCT01755169|E3|Reported Event|Ketamine 1 mg/kg/Dose|"A 5mL solution of 1 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
724186|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
717124|NCT01755169|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|"A 5mL solution of 0.5 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717125|NCT01755169|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|"A 5mL solution of 0.25 mg/kg/dose of ketamine will be given three times daily for 2 weeks.~Ketamine: Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant)."
717126|NCT01755156|B3|Baseline|Total|Total of all reporting groups
717127|NCT01755156|B2|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717128|NCT01755156|B1|Baseline|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717129|NCT01755156|P2|Participant Flow|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717130|NCT01755156|P1|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717131|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717132|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717133|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717134|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717135|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717136|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717137|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717138|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717139|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717140|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717141|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717142|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717143|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717144|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717145|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717146|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717147|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717148|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717149|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717150|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717151|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717152|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717231|NCT01754727|B1|Baseline|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717181|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
717153|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717154|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717155|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717156|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717157|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717158|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717159|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717160|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717161|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717162|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717163|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717164|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717165|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717166|NCT01755156|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717167|NCT01755156|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks
717168|NCT01755156|O1|Outcome|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717169|NCT01755156|E4|Reported Event|Placebo to Omarigliptin (Phase A) → Glimepiride (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: Matching placebo to omarigliptin capsule administered orally once weekly and glimepiride 1 or 2 mg tablet/capsule administered orally once daily (titrated up to 6 mg daily) for 80 weeks.
717170|NCT01755156|E3|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: Omarigliptin 25 mg capsule administered orally once weekly for 24 weeks. Phase B: Omarigliptin 25 mg capsule administered orally once weekly and matching placebo to glimepiride tablet/capsule administered orally once daily for 80 weeks.
717171|NCT01755156|E2|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: Matching placebo to omarigliptin capsule administered orally once weekly for 24 weeks.
717172|NCT01755156|E1|Reported Event|Omarigliptin (Phase A)|Phase A: Omarigliptin 25 mg capsule orally once a week for 24 weeks.
717173|NCT01755143|B3|Baseline|Total|Total of all reporting groups
717174|NCT01755143|B2|Baseline|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
717175|NCT01755143|B1|Baseline|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717176|NCT01755143|P2|Participant Flow|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
717177|NCT01755143|P1|Participant Flow|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717178|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
717179|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717180|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
718265|NCT01747928|B9|Baseline|Total|Total of all reporting groups
717182|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717183|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
717184|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717185|NCT01755143|O2|Outcome|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
717186|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717187|NCT01755143|O1|Outcome|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717188|NCT01755143|E2|Reported Event|Control Group|"Subjects randomized to the control group will not undergo a series of MRI scans but will come into the study office for a one hour waiting period at the 9-12 week post-implant visit.~Pacemaker System"
717189|NCT01755143|E1|Reported Event|MRI Group|"Subjects randomized to the Magnetic Resonance Imaging group will undergo a series of MRI scans at the 9-12 week visit post-implant.~Magnetic Resonance Imaging scan sequences of the head, neck, and chest~Pacemaker System"
717190|NCT01755026|B3|Baseline|Total|Total of all reporting groups
717191|NCT01755026|B2|Baseline|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
717192|NCT01755026|B1|Baseline|4 Gram Dose|4 gram dose of pre-operative prophylaxis
717193|NCT01755026|P2|Participant Flow|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
717194|NCT01755026|P1|Participant Flow|4 Gram Dose|4 gram dose of pre-operative prophylaxis
717195|NCT01755026|O2|Outcome|4 Gram Dose|4 gram dose of pre-operative prophylaxis
717196|NCT01755026|O1|Outcome|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
717197|NCT01755026|E2|Reported Event|2 Gram Dose of Cefazolin|2 gram dose of pre-operative cefazolin
717198|NCT01755026|E1|Reported Event|4 Gram Dose|4 gram dose of pre-operative prophylaxis
717199|NCT01754922|B3|Baseline|Total|Total of all reporting groups
717200|NCT01754922|B2|Baseline|Control|Veterans deployed to regions other than Iraq or Afghanistan or non-deployed
717201|NCT01754922|B1|Baseline|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
717202|NCT01754922|P2|Participant Flow|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
717203|NCT01754922|P1|Participant Flow|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
717204|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
717205|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
717206|NCT01754922|O2|Outcome|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
717207|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
717208|NCT01754922|O2|Outcome|Control|Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
717209|NCT01754922|O1|Outcome|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
717210|NCT01754922|E2|Reported Event|Control|OEF/OIF/OND Veterans deployed to regions other than Southwest Asia or non-deployed
717211|NCT01754922|E1|Reported Event|Exposed|Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
717212|NCT01754766|B4|Baseline|Total|Total of all reporting groups
717213|NCT01754766|B3|Baseline|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
717214|NCT01754766|B2|Baseline|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
717215|NCT01754766|B1|Baseline|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
717216|NCT01754766|P3|Participant Flow|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
717217|NCT01754766|P2|Participant Flow|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
717218|NCT01754766|P1|Participant Flow|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
717219|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
717220|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
717221|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
717222|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
717223|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
717224|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
717225|NCT01754766|O3|Outcome|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
717226|NCT01754766|O2|Outcome|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
717227|NCT01754766|O1|Outcome|AGN-229666 Dose A|One drop of AGN-229666 Dose A into each eye on Day 1 and Day 15.
717228|NCT01754766|E3|Reported Event|Vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
717229|NCT01754766|E2|Reported Event|AGN-229666 Dose B|One drop of AGN-229666 Dose B into each eye on Day 1 and Day 15.
717232|NCT01754727|P1|Participant Flow|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717278|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717233|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717234|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717235|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717236|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717237|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717238|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717239|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717240|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717241|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717242|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717243|NCT01754727|O1|Outcome|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717244|NCT01754727|E1|Reported Event|Participants With Ankylosing Spondylitis|Participants with ankylosing spondylitis treated with adalimumab in routine clinical practice.
717245|NCT01754714|B5|Baseline|Total|Total of all reporting groups
717246|NCT01754714|B4|Baseline|No Treatment|no study drug was administered
717247|NCT01754714|B3|Baseline|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717248|NCT01754714|B2|Baseline|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717249|NCT01754714|B1|Baseline|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717250|NCT01754714|P4|Participant Flow|No Treatment|No study drug was administered
717251|NCT01754714|P3|Participant Flow|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717252|NCT01754714|P2|Participant Flow|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717253|NCT01754714|P1|Participant Flow|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717254|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717255|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717256|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717257|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717258|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717259|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717260|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717261|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717262|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717263|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717264|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717265|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717266|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717267|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717268|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717269|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717270|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717271|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717272|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717273|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717274|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717275|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717276|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
718854|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
717277|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717279|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717280|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717281|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717282|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717283|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717284|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717285|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717286|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717287|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717288|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717289|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717290|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717291|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717292|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717293|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717294|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717295|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717296|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717297|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717298|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717299|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717300|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717301|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717302|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717303|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717304|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717305|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717306|NCT01754714|O4|Outcome|No Treatment|
717307|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717308|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717309|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717310|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717311|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717312|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717313|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717314|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717315|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717316|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717317|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717318|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717319|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717320|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717321|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717322|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717323|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717324|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717325|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717327|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717328|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717329|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717330|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717331|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717332|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717333|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717334|NCT01754714|O4|Outcome|No Treatment|No study drug was administered
717335|NCT01754714|O3|Outcome|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717336|NCT01754714|O2|Outcome|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717337|NCT01754714|O1|Outcome|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717338|NCT01754714|E4|Reported Event|No Treatment|No study drug was administered
717339|NCT01754714|E3|Reported Event|2000 mg SAMe|SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
717340|NCT01754714|E2|Reported Event|1500 mg SAMe|SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
717341|NCT01754714|E1|Reported Event|1000 mg SAMe (S-adenosyl-L-methionine)|SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
717342|NCT01754623|B1|Baseline|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
717343|NCT01754623|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
717344|NCT01754623|O2|Outcome|Resection Group -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
717345|NCT01754623|O1|Outcome|All Participants -Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
717346|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
717347|NCT01754623|O1|Outcome|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
717348|NCT01754623|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|"Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT).~After radiation, participants will be re-evaluated for surgery."
717349|NCT01754519|B1|Baseline|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717350|NCT01754519|P1|Participant Flow|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717351|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717352|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717353|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
724187|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
717354|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717355|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717356|NCT01754519|O1|Outcome|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717357|NCT01754519|E1|Reported Event|Treatment (Radiation Therapy)|"Patients undergo wide local excision breast surgery and SFRT over 60-100 minutes once negative margins are obtained.~Therapeutic Conventional Surgery: Undergo wide local excision breast surgery~Radiation Therapy: Undergo SFRT~Laboratory Biomarker Analysis: Correlative studies~Quality-of-Life Assessment: Ancillary studies"
717358|NCT01754493|B1|Baseline|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717359|NCT01754493|P1|Participant Flow|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717360|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717361|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717362|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717363|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717364|NCT01754493|O1|Outcome|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717365|NCT01754493|E1|Reported Event|Treatment With Duloxetine|"Patients will receive open treatment with Duloxetine~Duloxetine: This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms."
717366|NCT01754480|B3|Baseline|Total|Total of all reporting groups
717367|NCT01754480|B2|Baseline|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717368|NCT01754480|B1|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
717369|NCT01754480|P2|Participant Flow|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717370|NCT01754480|P1|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
717371|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717474|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717372|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
719769|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
717373|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717374|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
717375|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717376|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
717377|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717378|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
717379|NCT01754480|O2|Outcome|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717380|NCT01754480|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
717381|NCT01754480|E2|Reported Event|Surgicel®|Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose. Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
717382|NCT01754480|E1|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols: Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
717383|NCT01754467|B1|Baseline|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
717384|NCT01754467|P1|Participant Flow|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
717385|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
717386|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
717387|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
717388|NCT01754467|O1|Outcome|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
717389|NCT01754467|E1|Reported Event|NEAT!|"Participants will use the NEAT! smartphone application and accelerometer over a 1 month period.~NEAT!: Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period."
717390|NCT01754402|B4|Baseline|Total|Total of all reporting groups
717391|NCT01754402|B3|Baseline|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
717392|NCT01754402|B2|Baseline|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
717393|NCT01754402|B1|Baseline|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
722968|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
717475|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717394|NCT01754402|P3|Participant Flow|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
717395|NCT01754402|P2|Participant Flow|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
717396|NCT01754402|P1|Participant Flow|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
717397|NCT01754402|O3|Outcome|Expansion: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered at the Maximum Tolerated Dose."
717398|NCT01754402|O2|Outcome|Cohort 2: 120mg Bendamustine + 4mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
717399|NCT01754402|O1|Outcome|Cohort 1: 120mg Bendamustine + 3mg Pomalidomide|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~After 6 cycles of treatment, dexamethasone may be decreased to 20mg. After total 12 cycles of treatment, subjects will proceed to the maintenance phase until time of progression.~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort."
717400|NCT01754402|O1|Outcome|Bendamustine+Pomalidomide+Dexamethasone|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)~Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.~Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.~Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,"
717401|NCT01754402|E1|Reported Event|Bendamustine+Pomalidomide+Dexamethasone|"Pomalidomide: once daily oral (PO) dosing on days 1-21, every 28 days~Bendamustine: once intravenous (IV) dosing on day 1, every 28 days~Dexamethasone: weekly PO or IV dosing on days 1, 8, 15, and 22 every 28 days~Study treatment will be administered starting at Cohort 1 for up to four sequential cohorts, with 3-6 patients in each cohort. (Dose escalation)~Bendamustine: Bendamustine 120mg/m2 (cohort 1, 2) or 150 mg/m2 (cohort 3), or 180mg/m2 (cohort 4) will be administered intravenously on day 1, every 28 days for 12 cycles.~Pomalidomide: Pomalidomide 3mg (cohort 1) or 4mg (cohort 2, 3, 4) will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.~Dexamethasone: Dexamethasone will be administered weekly orally or intravenously on days 1, 8,"
717402|NCT01754376|B1|Baseline|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717403|NCT01754376|P1|Participant Flow|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717404|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717405|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717406|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717407|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717408|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib 960 milligrams twice a day plus intravenous aldesleukin 600,000 IU/kg every eight hours to tolerance (maximum 14 doses) over five days on days 15-19 of cycle 1 and on days 1-5 of cycle 2. (A cycle is 28 days)~The first course of treatment will consist of three 28-day cycles (12 weeks): 2 weeks of lead-in vemurafenib plus 3 weeks on IL-2 plus 7 weeks wait.~A second course may be given at the discretion of the investigator, if there is evidence of tumor stability or regression.~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717409|NCT01754376|O1|Outcome|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717410|NCT01754376|E1|Reported Event|Treatment Arm|"Oral vemurafenib twice a day IV infusion of aldesleukin~Aldesleukin: Intravenous therapy given every 8 hours for up to 14 doses per week.~Vemurafenib: Tablets given twice daily."
717411|NCT01753856|B3|Baseline|Total|Total of all reporting groups
717412|NCT01753856|B2|Baseline|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717413|NCT01753856|B1|Baseline|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717414|NCT01753856|P2|Participant Flow|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717415|NCT01753856|P1|Participant Flow|Teriparatide|"Teriparatide: 20-microgram (µg) subcutaneous (SC) injection once daily for 6 months.~DEM: 150-milligram (mg) tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 milligrams per day (mg/day) administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 International Units per day (IU/day) administered orally for 6 months."
717416|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717417|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717418|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717419|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717467|NCT01753557|P2|Participant Flow|Treatment-Relapsed|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
718200|NCT01749410|B1|Baseline|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
717420|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717421|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717422|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717423|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717424|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717425|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717426|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717427|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717428|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717429|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717430|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717468|NCT01753557|P1|Participant Flow|Treatment-Naive|Drug: MP-424 (generic name:Telaprevir) 750mg every 8 hours(q8h) for 12 weeks Drug: RBV (Ribavirin) 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717469|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717431|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717432|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717433|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717434|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717435|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717436|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717437|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717438|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717439|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717440|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717441|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717470|NCT01753557|O1|Outcome|Treatment-Naïve|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717471|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717442|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717443|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717444|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717445|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717446|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717447|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717448|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717449|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717450|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717451|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717452|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717472|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717473|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717453|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717454|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717455|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717456|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717457|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717458|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717459|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717460|NCT01753856|O2|Outcome|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717461|NCT01753856|O1|Outcome|Teriparatide|"Teriparatide: 20-mcg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717462|NCT01753856|E2|Reported Event|Denosumab|"Denosumab: A single 60-mg SC injection.~DEM: 150-mg tablets administered orally on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717463|NCT01753856|E1|Reported Event|Teriparatide|"Teriparatide: 20-µg SC injection once daily for 6 months.~DEM: 150-mg tablets administered orally, on the following days, 18 days prior to randomization:~Days 1, 2, 3, 16, 17, and 18: 150 mg DEM every 6 hours.~Days 4 through 15: DEM was not administered.~TET: 250-mg capsules administered orally on the following days, 22 days prior to biopsy procedure:~Days 1, 2, 3, 16, 17, and 18: 250 mg TET every 6 hours.~Days 4 through 15: TET was not administered.~Calcium Supplements: Approximately 1000 mg/day administered orally for 6 months.~Vitamin D Supplements: Approximately 800 to 1200 IU/day administered orally for 6 months."
717464|NCT01753557|B3|Baseline|Total|Total of all reporting groups
717465|NCT01753557|B2|Baseline|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717466|NCT01753557|B1|Baseline|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717476|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717477|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717478|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717479|NCT01753557|O2|Outcome|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717480|NCT01753557|O1|Outcome|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717481|NCT01753557|E2|Reported Event|Treatment-Relapsed|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717482|NCT01753557|E1|Reported Event|Treatment-Naive|Drug: MP-424 750mg q8h for 12 weeks Drug: RBV 600 - 1000 mg/day based on body weight for 24 weeks Drug: PEG-IFN alfa-2a 180mcg/kg/week for 24 weeks
717483|NCT01753518|B3|Baseline|Total|Total of all reporting groups
717484|NCT01753518|B2|Baseline|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717485|NCT01753518|B1|Baseline|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717486|NCT01753518|P2|Participant Flow|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717487|NCT01753518|P1|Participant Flow|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717488|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717489|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717490|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717491|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717492|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717493|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717494|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717495|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717496|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717497|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717498|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717499|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717500|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717501|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717502|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717503|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717504|NCT01753518|O2|Outcome|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717505|NCT01753518|O1|Outcome|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717506|NCT01753518|E2|Reported Event|Subcuticular Staple|Subcuticular staples are a newer modality than suture, but are currently an accepted and widely used skin closure technique.
717507|NCT01753518|E1|Reported Event|Subcuticular Suture|Subcuticular suture has been used for many years to close skin incisions.
717508|NCT01753336|B1|Baseline|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717509|NCT01753336|P1|Participant Flow|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 Units (U)/vial, 2 millilitre (mL) dilution on Day 1 of up to 3 treatment cycles. Subjects who were botulinum neurotoxin (BoNT) treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum toxin type A haemagglutinin complex (abobotulinumtoxinA).
717526|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717510|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717511|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717512|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717513|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717514|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717515|NCT01753336|O1|Outcome|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717516|NCT01753336|E1|Reported Event|Total Dysport®|Subjects received up to 3 doses of Dysport® 500 U/vial, 2 mL dilution on Day 1 of up to 3 treatment cycles. Subjects who were BoNT treatment naïve at the start of Study 169 received a starting dose of 500 U/2 mL Dysport®, and subjects who were non-naïve to BoNT treatment received the same dose they had received on Day 1 of Study 169. Subjects received Dysport® by intramuscular injection into the same neck muscles that had been used for injection in Study 169. Retreatment occurred every 12 to 16 weeks, dependent on the investigator's clinical judgment. Follow-up visits occurred at Weeks 4 and 12 of each treatment cycle. Subjects were determined to have completed the study at Week 12 of Treatment Cycle 3. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-haemagglutinin complex (abobotulinumtoxinA).
717517|NCT01753323|B4|Baseline|Total|Total of all reporting groups
717518|NCT01753323|B3|Baseline|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717519|NCT01753323|B2|Baseline|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717520|NCT01753323|B1|Baseline|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717521|NCT01753323|P3|Participant Flow|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717522|NCT01753323|P2|Participant Flow|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717523|NCT01753323|P1|Participant Flow|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717524|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717525|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717527|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717528|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717529|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717530|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717531|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717532|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717533|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717534|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717535|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717536|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717537|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717538|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717539|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717540|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717541|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717542|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717543|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717544|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717545|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717546|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717547|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717548|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717549|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717550|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717551|NCT01753323|O1|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717552|NCT01753323|O3|Outcome|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717553|NCT01753323|O2|Outcome|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717554|NCT01753323|O1|Outcome|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717555|NCT01753323|E3|Reported Event|Part 2 - Cohort 3: P. Falciparum: KAF156 800mg Single Dose|Participants with Plasmodium falciparum malaria received a single dose of KAF156 800mg.
717556|NCT01753323|E2|Reported Event|Part 1 - Cohort 2: P. Falciparum: KAF156 400mg QD|Participants with Plasmodium falciparum malaria received KAF156 400mg once a day for three days.
717557|NCT01753323|E1|Reported Event|Part 1 - Cohort 1: P. Vivax: KAF156 400mg QD|Participants with Plasmodium vivax malaria received KAF156 400 mg once a day for three days.
717558|NCT01753310|B3|Baseline|Total Title|
717559|NCT01753310|B2|Baseline|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717560|NCT01753310|B1|Baseline|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717561|NCT01753310|P2|Participant Flow|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717617|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717618|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717562|NCT01753310|P1|Participant Flow|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717563|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717564|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717565|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717566|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717567|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717568|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717569|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717570|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717571|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717572|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717573|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717574|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717575|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717576|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717577|NCT01753310|O2|Outcome|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717578|NCT01753310|O1|Outcome|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717579|NCT01753310|E2|Reported Event|Placebo|Subjects were randomised to receive a single dose of placebo by intramuscular injection. The placebo was provided in glass vials indistinguishable from the Dysport® vials. The placebo contained only the excipients used in Dysport® without the toxin, provided as a white lyophilised powder for reconstitution with the same storage and preparation conditions as for Dysport®.
717670|NCT01751867|B3|Baseline|Total|Total of all reporting groups
717580|NCT01753310|E1|Reported Event|Dysport®|Subjects were randomised to receive a single intramuscular injected dose of study medication, Dysport® 500 U/vial using a 2 mL dilution scheme. The dose of Dysport® was between 250 U and 500 U divided among a minimum of two clinically indicated muscles. Dysport® contains the neurotoxin Clostridium botulinum type A toxin-hemagglutinin complex (abobotulinumtoxinA).
717581|NCT01753115|B4|Baseline|Total|Total of all reporting groups
717582|NCT01753115|B3|Baseline|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
717583|NCT01753115|B2|Baseline|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717584|NCT01753115|B1|Baseline|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717585|NCT01753115|P3|Participant Flow|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
717586|NCT01753115|P2|Participant Flow|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717587|NCT01753115|P1|Participant Flow|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717588|NCT01753115|O2|Outcome|BioThrax Only (Arm 3)|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
717589|NCT01753115|O1|Outcome|BioThrax + Ciprofloxacin (Arms 1 + 2)|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717590|NCT01753115|O1|Outcome|Arm 1 = BioThrax (0.5 mL) + Ciprofloxacin (500 mg Bid) + PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717591|NCT01753115|E3|Reported Event|BioThrax Only|BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
717592|NCT01753115|E2|Reported Event|BioThrax + Ciprofloxacin no PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717593|NCT01753115|E1|Reported Event|BioThrax + Ciprofloxacin PK|"BioThrax: route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule~Ciprofloxacin: 500 mg twice a day"
717594|NCT01753076|B3|Baseline|Total|Total of all reporting groups
717595|NCT01753076|B2|Baseline|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
717596|NCT01753076|B1|Baseline|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
717597|NCT01753076|P2|Participant Flow|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46.
717598|NCT01753076|P1|Participant Flow|Placebo|Participants (par) received placebo once every 2 weeks by intravenous infusion up to Week 46.
717599|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717600|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717601|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717602|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717603|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717604|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717605|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
717606|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Outcome assessments conducted at Week 48 and Week 60.
717607|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717608|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717609|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717610|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717611|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717612|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717613|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717614|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717615|NCT01753076|O2|Outcome|Ozanezumab 15 mg/kg|Participants received ozanezumab 15 milligrams per kilogram (mg/kg) once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717616|NCT01753076|O1|Outcome|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46. Final outcome assessment conducted at Week 48.
717619|NCT01753076|E2|Reported Event|Ozanezumab IV|Participants received ozanezumab 15 mg/kg once every 2 weeks by intravenous infusion up to Week 46.
717620|NCT01753076|E1|Reported Event|Placebo|Participants received placebo once every 2 weeks by intravenous infusion up to Week 46.
717621|NCT01752907|B3|Baseline|Total|Total of all reporting groups
717622|NCT01752907|B2|Baseline|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717623|NCT01752907|B1|Baseline|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717624|NCT01752907|P2|Participant Flow|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717625|NCT01752907|P1|Participant Flow|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717626|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717627|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717628|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717629|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717630|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717631|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717632|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717633|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717634|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717635|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717636|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717637|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717638|NCT01752907|O2|Outcome|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717639|NCT01752907|O1|Outcome|General Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717908|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
718203|NCT01749410|E1|Reported Event|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
717640|NCT01752907|E2|Reported Event|Bone Pain Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a bone pain education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717641|NCT01752907|E1|Reported Event|General Chemotherapy Education DVD|Participants received chemotherapy and pegfilgrastim administered as a single subcutaneous injection dose of 6 mg 24 to 72 hours after chemotherapy. Participants were required to watch a general chemotherapy side effects education DVD on 2 separate visits to the clinic prior to the first administration of pegfilgrastim in cycle 1.
717642|NCT01752855|B3|Baseline|Total|Total of all reporting groups
717643|NCT01752855|B2|Baseline|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717644|NCT01752855|B1|Baseline|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717645|NCT01752855|P2|Participant Flow|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717646|NCT01752855|P1|Participant Flow|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717647|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717648|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717649|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717650|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717651|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717652|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717653|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717654|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717655|NCT01752855|O2|Outcome|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717656|NCT01752855|O1|Outcome|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717657|NCT01752855|E2|Reported Event|Current Formulation for 24 Weeks, New Formulation for 24 Weeks|Current formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week
717658|NCT01752855|E1|Reported Event|New Formulation for 48 Weeks|New formulation of adalimumab 40 mg every other week for 24 weeks in Study NCT01712178, followed by 24 weeks of treatment with the new formulation of adalimumab 40 mg every other week.
717659|NCT01752023|B3|Baseline|Total|Total of all reporting groups
717660|NCT01752023|B2|Baseline|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
717661|NCT01752023|B1|Baseline|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
717662|NCT01752023|P2|Participant Flow|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
717663|NCT01752023|P1|Participant Flow|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
717664|NCT01752023|O2|Outcome|Cisplatin + Gemcitabine|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
717665|NCT01752023|O1|Outcome|Cisplatin + Gemcitabine With SUBATM-itraconazole|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
717666|NCT01752023|O2|Outcome|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
717667|NCT01752023|O1|Outcome|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
717668|NCT01752023|E2|Reported Event|Arm B|"Arm B = Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then Best supportive care.~Arm B: Active Comparator"
717669|NCT01752023|E1|Reported Event|Arm A|"SUBATM-itraconazole 200 mg BID, Cisplatin 75 mg/m2 day 1, Gemcitabine 1000 mg/m2 days 1 + 8 for 6 cycles. Then SUBATM-itraconazole 200 mg BID alone.~Arm A: Experimental Arm"
717671|NCT01751867|B2|Baseline|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717672|NCT01751867|B1|Baseline|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717673|NCT01751867|P2|Participant Flow|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717674|NCT01751867|P1|Participant Flow|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717675|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717676|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717677|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717678|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717679|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717680|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717681|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717682|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717683|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717684|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717685|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717686|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717687|NCT01751867|O2|Outcome|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717688|NCT01751867|O1|Outcome|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717689|NCT01751867|E2|Reported Event|5-Day Posology|Decitabine 20 mg/m^2 administered by a 1-hour intravenous infusion once daily, on Days 1 through 5. Cycles repeated every 4 weeks.
717690|NCT01751867|E1|Reported Event|3-Day Posology|Decitabine 15 milligram per meter^2 (mg/m^2) administered by continuous intravenous infusion over a 3-hour period, repeated every 8 hours for 3 consecutive days. Cycles repeated every 6 weeks.
717691|NCT01751802|B3|Baseline|Total|Total of all reporting groups
717692|NCT01751802|B2|Baseline|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
717693|NCT01751802|B1|Baseline|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
717694|NCT01751802|P2|Participant Flow|Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
717695|NCT01751802|P1|Participant Flow|Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
717696|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime for 6 weeks~Placebo: Placebo for Ecopipam"
717697|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime for 6 weeks~Ecopipam: Antagonist of the dopamine D1 receptor"
717698|NCT01751802|O2|Outcome|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
717699|NCT01751802|O1|Outcome|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
717700|NCT01751802|O4|Outcome|Subject #4: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
718204|NCT01748955|B3|Baseline|Total|Total of all reporting groups
717701|NCT01751802|O3|Outcome|Subject #3: Placebo Then Ecopipam Then Placebo|Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks
717702|NCT01751802|O2|Outcome|Subject #2: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
717703|NCT01751802|O1|Outcome|Subject #1: Ecopipam Then Placebo Then Ecopipam|Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks; then Placebo, the inactive substance being tested to be taken once a day at bedtime for 6 weeks; then Ecopipam, the active substance being tested, 100mg tablets for body weight > 20kg OR 50 mg tablets for body weight up to 20kg, once daily at bedtime for 6 weeks
717704|NCT01751802|E2|Reported Event|Placebo|"Inactive substance being tested, orally once a day at bedtime~Placebo: Placebo for Ecopipam"
717705|NCT01751802|E1|Reported Event|Ecopipam|"Active substance being tested, orally once a day at bedtime~Ecopipam: Antagonist of the dopamine D1 receptor"
717706|NCT01751308|B6|Baseline|Total|Total of all reporting groups
717707|NCT01751308|B5|Baseline|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717708|NCT01751308|B4|Baseline|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717709|NCT01751308|B3|Baseline|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717710|NCT01751308|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717711|NCT01751308|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717712|NCT01751308|P5|Participant Flow|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717713|NCT01751308|P4|Participant Flow|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717714|NCT01751308|P3|Participant Flow|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717715|NCT01751308|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717716|NCT01751308|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression (DP) or discontinuation due to adverse events (AE) or death (from any cause).
717717|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717718|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717719|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717720|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
717721|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717722|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717723|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717724|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
717725|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AEor death (from any cause).
717726|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717727|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717728|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
717729|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717730|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717731|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
718201|NCT01749410|P1|Participant Flow|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
717732|NCT01751308|O3|Outcome|Phase 1 and 2: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle (at the MTD dose determined in Phase 1) in Phase 1 and Phase 2 until DP or discontinuation due to AE or death (from any cause).
717733|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717734|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717735|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717736|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717737|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717738|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717739|NCT01751308|O5|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the maximum tolerated dose (MTD) as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717740|NCT01751308|O4|Outcome|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717741|NCT01751308|O3|Outcome|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717742|NCT01751308|O2|Outcome|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717743|NCT01751308|O1|Outcome|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717744|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717745|NCT01751308|O1|Outcome|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717746|NCT01751308|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 mg/m^2, 25 mg/m^2, 30 mg/m^2 or 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717747|NCT01751308|E5|Reported Event|Phase 2: Cabazitaxel 30 mg/m^2|Cabazitaxel at the MTD as determined in phase 1 (30 mg/m^2) IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717748|NCT01751308|E4|Reported Event|Phase 1: Cabazitaxel 35 mg/m^2|Cabazitaxel 35 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717749|NCT01751308|E3|Reported Event|Phase 1: Cabazitaxel 30 mg/m^2|Cabazitaxel 30 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717750|NCT01751308|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717751|NCT01751308|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle until DP or discontinuation due to AE or death (from any cause).
717752|NCT01751178|B4|Baseline|Total|Total of all reporting groups
717753|NCT01751178|B3|Baseline|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
717754|NCT01751178|B2|Baseline|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717755|NCT01751178|B1|Baseline|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717756|NCT01751178|P3|Participant Flow|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
717757|NCT01751178|P2|Participant Flow|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717758|NCT01751178|P1|Participant Flow|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717759|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
717760|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717761|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717762|NCT01751178|O3|Outcome|Reference|Brusing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
717763|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717764|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717765|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks
718202|NCT01749410|O1|Outcome|All Participants|Previous treatment with onabotulinumtoxinA for Chronic Migraine based on retrospective medical record review.
717766|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717767|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717768|NCT01751178|O3|Outcome|Reference|Brushing alone with the standard toothpaste for 1 timed minute twice daily for 6 weeks.
717769|NCT01751178|O2|Outcome|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717770|NCT01751178|O1|Outcome|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717771|NCT01751178|E3|Reported Event|Reference|Brushing alone with the standard toothpaste for one timed minute twice daily for 6 weeks.
717772|NCT01751178|E2|Reported Event|Mouthwash Without Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717773|NCT01751178|E1|Reported Event|Mouthwash With Alcohol|Rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
717774|NCT01751165|B4|Baseline|Total|Total of all reporting groups
717775|NCT01751165|B3|Baseline|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717776|NCT01751165|B2|Baseline|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717777|NCT01751165|B1|Baseline|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717778|NCT01751165|P3|Participant Flow|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717779|NCT01751165|P2|Participant Flow|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717780|NCT01751165|P1|Participant Flow|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717781|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717782|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717783|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717784|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717785|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717786|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717787|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717788|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717789|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717790|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717791|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717792|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717793|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717794|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717795|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717796|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717797|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717798|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717799|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717800|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717801|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717802|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717803|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717804|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717805|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717806|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717807|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717808|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717809|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717810|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717811|NCT01751165|O3|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717812|NCT01751165|O2|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717813|NCT01751165|O1|Outcome|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717814|NCT01751165|O2|Outcome|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717815|NCT01751165|O1|Outcome|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717816|NCT01751165|E3|Reported Event|GSK1437173A-0,12 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,12-month schedule.
717817|NCT01751165|E2|Reported Event|GSK1437173A-0,6 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,6-month schedule.
717818|NCT01751165|E1|Reported Event|GSK1437173A-0,2 M Group|Healthy subjects aged 50 or older received the GSK1437173A vaccine administered intramuscularly on a 0,2-month schedule.
717819|NCT01751113|B1|Baseline|Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|All participants received one of the following 3 treatments in one of three 4-week treatment periods separated by a 2-week washout period:Ado 50/250 µg BID (morning and evening) + Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) + Tio matching placebo QD (morning), and Tio 18 µg QD (morning) + Ado matching placebo BID (morning and evening). Participants were randomized to one of the 6 following treatment sequences: (1) Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg (2) Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg (3) Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg (4) Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg (5) Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg (6) Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg. Ado 50/250 µg and its matching placebo were administered via DISKUS inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants used salbutamol inhaler as relief medication throughout the study.
717820|NCT01751113|P6|Participant Flow|Sequence 6: Tio 18 µg, Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
717821|NCT01751113|P5|Participant Flow|Sequence 5: Ado 50/250 µg+Tio 18 µg, Ado 50/250 µg, Tio 18 µg|Participants received Ado 50/250 µg BID plus Tio 18 µg QD (morning), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with salbutamol inhaler to be used as relief medication throughout the study.
717822|NCT01751113|P4|Participant Flow|Sequence 4: Ado 50/250 µg, Tio 18 µg, Ado 50/250 µg+Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717823|NCT01751113|P3|Participant Flow|Sequence 3: Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg, Tio 18 µg|Participants received Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), Ado 50/250 µg BID plus Tio 18 µg QD (morning), and Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening) in Treatment Period 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717824|NCT01751113|P2|Participant Flow|Sequence 2: Tio 18 µg, Ado 50/250 µg, Ado 50/250 µg+Tio 18 µg|Participants received Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning), and Ado 50/250 µg BID plus Tio 18 µg QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717825|NCT01751113|P1|Participant Flow|Sequence 1: Ado 50/250 µg+Tio 18 µg, Tio 18 µg, Ado 50/250 µg|Participants received salmeterol xinafoate/fluticasone propionate (Ado) 50/250 micrograms (µg) twice daily (BID) (morning and evening) plus tiotropium bromide (Tio) 18 µg once daily (QD) (morning), Tio 18 µg QD (morning) plus Ado matching placebo BID (morning and evening), and Ado 50/250 µg BID (morning and evening) plus Tio matching placebo QD (morning) in Treatment Periods 1, 2, and 3, respectively. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Ado 50/250 µg and its matching placebo were administered via a dry powder inhaler and Tio 18 µg and its matching placebo were administered via a HandiHaler inhaler. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717826|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717827|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717828|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717829|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717830|NCT01751113|O2|Outcome|Tio 18 µg BID|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717831|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717832|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717833|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717834|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717835|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717836|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717837|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717838|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717839|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717840|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717909|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
717841|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717842|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717843|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717844|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717845|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717846|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717847|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717848|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717849|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717850|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717851|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717852|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717853|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717854|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717855|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717856|NCT01751113|O3|Outcome|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717857|NCT01751113|O2|Outcome|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717910|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
717858|NCT01751113|O1|Outcome|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717859|NCT01751113|E3|Reported Event|Ado 50/250 µg BID|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio matching placebo QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717860|NCT01751113|E2|Reported Event|Tio 18 µg QD|Participants received Tio 18 µg QD (morning) via a HandiHaler inhaler plus Ado matching placebo BID (morning and evening) via dry powder inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717861|NCT01751113|E1|Reported Event|Ado 50/250 µg BID+Tio 18 µg QD|Participants received Ado 50/250 µg BID (morning and evening) via a dry powder inhaler plus Tio 18 µg QD (morning) via a HandiHaler inhaler, in one of the three treatment periods. Each treatment period consisted of 4 weeks and separated by a 2-week washout period. Participants were provided with a salbutamol inhaler to be used as relief medication throughout the study.
717862|NCT01751087|B4|Baseline|Total|Total of all reporting groups
717863|NCT01751087|B3|Baseline|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717864|NCT01751087|B2|Baseline|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717865|NCT01751087|B1|Baseline|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717866|NCT01751087|P3|Participant Flow|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717867|NCT01751087|P2|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717868|NCT01751087|P1|Participant Flow|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717869|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717870|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717871|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717872|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717873|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717874|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717875|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717876|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717877|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717878|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717879|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717880|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717881|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717882|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717883|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717884|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717885|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717886|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717887|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717888|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717889|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717890|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717891|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717892|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717893|NCT01751087|O3|Outcome|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717894|NCT01751087|O2|Outcome|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717895|NCT01751087|O1|Outcome|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717896|NCT01751087|E3|Reported Event|Osmotic Dilators + Mifepristone + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral mifepristone 200 mg on Day 1, and buccal placebo on Day 2.~Mifepristone: oral mifepristone 200 mg on Day 1.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for misoprostol, on day 2"
717897|NCT01751087|E2|Reported Event|Osmotic Dilators + Placebo (Vit c) + Misoprostol|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal misoprostol 400 mcg on Day 2.~misoprostol: buccal misoprostol 400 mcg on Day 2~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1"
717898|NCT01751087|E1|Reported Event|Osmotic Dilators + Placebo (Vit c) + Placebo (Vit B12)|"Women will receive osmotic dilators on Day 1, oral placebo on Day 1, and buccal placebo on Day 2.~Osmotic dilators: osmotic dilators on Day 1~placebo: placebo for mifepristone, on day 1~placebo: placebo for misoprostol, on day 2"
717899|NCT01751022|B4|Baseline|Total|Total of all reporting groups
717900|NCT01751022|B3|Baseline|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
717901|NCT01751022|B2|Baseline|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
717902|NCT01751022|B1|Baseline|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
717903|NCT01751022|P3|Participant Flow|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
717904|NCT01751022|P2|Participant Flow|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
717905|NCT01751022|P1|Participant Flow|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
717906|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
717907|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
717911|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and complete Medtronic Quad CRT-D system and valid measures of lead impedance at 6-month visit.
717912|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted successfully.
717913|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted successfully.
717914|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted successfully.
717915|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
717916|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up.
717917|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
717918|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant
717919|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant
717920|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant
717921|NCT01751022|O3|Outcome|Model 4598|Patients with an implant attempt for the Attain Performa Lead Model 4598
717922|NCT01751022|O2|Outcome|Model 4398|Patients with an implant attempt for the Attain Performa Lead Model 4398
717923|NCT01751022|O1|Outcome|Model 4298|Patients with an implant attempt for the Attain Performa Lead Model 4298
717924|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month.
717925|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
717926|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and at least one valid pacing threshold at any LV lead pacing polarity measured at the 6 month follow-up visit.
717927|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with Attain Performa LV Lead Model 4598 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
717928|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with Attain Performa LV Lead Model 4398 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
717929|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with Attain Performa LV Lead Model 4298 implanted and valid pacing thresholds measured at the 6 month follow-up visit.
717930|NCT01751022|O3|Outcome|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant.
717931|NCT01751022|O2|Outcome|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant.
717932|NCT01751022|O1|Outcome|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant.
717933|NCT01751022|E3|Reported Event|Attain Performa LV Lead Model 4598|Subjects with an attempted Attain Performa LV Lead Model 4598 implant. Results as showed in the Model 4598 PMA-S Clinical Report Version 1, 29AUG2014.
717934|NCT01751022|E2|Reported Event|Attain Performa LV Lead Model 4398|Subjects with an attempted Attain Performa LV Lead Model 4398 implant. Results as showed in the Model 4398 PMA-S Clinical Report Version 3, 03SEP2014.
717935|NCT01751022|E1|Reported Event|Attain Performa LV Lead Model 4298|Subjects with an attempted Attain Performa LV Lead Model 4298 implant. Results as showed in the Model 4298 PMA-S Clinical Report Version 1, 27MAR2014.
717936|NCT01750840|B1|Baseline|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
717937|NCT01750840|P1|Participant Flow|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
717938|NCT01750840|O1|Outcome|Stimulation Group|"All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.~Biomet EBI Bone Healing System: A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.~Biomet Orthopak Non-Invasive Bone Growth Stimulator: A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.~Biomet SpinalPak Non-Invasive Spine Fusion Stimulator System: A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day."
717939|NCT01750840|O1|Outcome|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
717940|NCT01750840|E1|Reported Event|Stimulation Group|All patients will receive either the Biomet EBI Bone Healing System, Biomet OrthoPak Non-invasive Bone Growth Stimulator System or Biomet SpinalPak Non-Invasive Spine Fusion Stimulator Systems.
717941|NCT01750684|B3|Baseline|Total|Total of all reporting groups
717942|NCT01750684|B2|Baseline|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
717943|NCT01750684|B1|Baseline|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
718037|NCT01750086|B1|Baseline|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
717944|NCT01750684|P2|Participant Flow|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
717945|NCT01750684|P1|Participant Flow|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
717946|NCT01750684|O2|Outcome|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
717947|NCT01750684|O1|Outcome|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
717948|NCT01750684|E2|Reported Event|AC105|"Patients randomized (1:1) to the active drug arm will receive an initial intravenous infusion of AC105 for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~AC105"
717949|NCT01750684|E1|Reported Event|Placebo|"Patients randomized (1:1) to the placebo arm will receive an initial intravenous infusion of saline for 30 minutes within a pre-specified time window (12, 9, 6 hours post-injury). Patients will receive 5 additional infusions of the same dose and duration at 6 -hour intervals.~Placebo"
717950|NCT01750502|B3|Baseline|Total|Total of all reporting groups
717951|NCT01750502|B2|Baseline|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
717952|NCT01750502|B1|Baseline|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
717953|NCT01750502|P2|Participant Flow|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
717954|NCT01750502|P1|Participant Flow|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
717955|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
717956|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
717957|NCT01750502|O2|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
717958|NCT01750502|O1|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
717959|NCT01750502|O3|Outcome|5 Minutes After the Opening of the Balloon|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
717960|NCT01750502|O2|Outcome|After Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
717961|NCT01750502|O1|Outcome|Before Surgery 5 Minutes|Participants, who are diagnosed as coronary-artery-disease with acute coronary syndromes or stable ischemic heart disease,they Were undergoing PCI.
717962|NCT01750502|O2|Outcome|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
717963|NCT01750502|O1|Outcome|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
717964|NCT01750502|E2|Reported Event|Non-coronary-artery-disease Group|Participants, who are diagnosed as non-coronary-artery-disease without acute coronary syndromes and stable ischemic heart disease, will not receive stent.
717965|NCT01750502|E1|Reported Event|Coronary-artery-disease Group|Participants, who are diagnosed as coronary-artery-disease which including acute coronary syndromes and stable ischemic heart disease, will receive at least one stent.
717966|NCT01750398|B1|Baseline|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
718006|NCT01750346|E1|Reported Event|0.05% AH-8|"Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
718007|NCT01750294|B1|Baseline|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
718008|NCT01750294|P1|Participant Flow|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
718009|NCT01750294|O1|Outcome|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
718010|NCT01750294|E1|Reported Event|Chlorthalidone|Open-label, forced-titration of Chlorthalidone (25mg/day at baseline)
718011|NCT01750255|B3|Baseline|Total|Total of all reporting groups
717967|NCT01750398|P1|Participant Flow|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717968|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717969|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717970|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717971|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717972|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717973|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
718033|NCT01750242|O1|Outcome|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus and with readable images.
718034|NCT01750242|E1|Reported Event|Subjects With Advanced Parkinson's Disease|The study protocol did not require safety data to be collected for the study.
718035|NCT01750086|B3|Baseline|Total|Total of all reporting groups
722969|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
717974|NCT01750398|O1|Outcome|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717975|NCT01750398|E1|Reported Event|ADT Plus IM Testosterone|"Men with castration-resistant prostate cancer will initiate androgen deprivation therapy (ADT) with an LHRH agonist (e.g. goserelin or leuprolide) for a total of 6 months. After this initial “lead-in” castration phase, patients will receive intermittent intramuscular testosterone cypionate or testosterone enanthate (T) at a dose of 400 mg while continuing on ADT.~Testosterone cypionate: DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.~Goserelin: Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist.~Leuprolide: Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection."
717976|NCT01750346|B4|Baseline|Total|Total of all reporting groups
717977|NCT01750346|B3|Baseline|Placebo|Participants in the Placebo arm received the placebo.
717978|NCT01750346|B2|Baseline|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717979|NCT01750346|B1|Baseline|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717980|NCT01750346|P3|Participant Flow|Placebo|Participants in the Placebo arm received the placebo.
717981|NCT01750346|P2|Participant Flow|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717982|NCT01750346|P1|Participant Flow|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717983|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
717984|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717985|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717986|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
717987|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717988|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717989|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
717990|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717991|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717992|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
717993|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717994|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717995|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
717996|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717997|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
717998|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
717999|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
718000|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
718001|NCT01750346|O3|Outcome|Placebo|Participants in the Placebo arm received the placebo.
718002|NCT01750346|O2|Outcome|0.025% AH-8|Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
718003|NCT01750346|O1|Outcome|0.05% AH-8|Participants in the 0.05% AH-8 arm received the higher dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.
718004|NCT01750346|E3|Reported Event|Placebo|"Participants in the Placebo arm received the placebo.~Topical acetyl hexapeptide-8"
718005|NCT01750346|E2|Reported Event|0.025% AH-8|"Participants in the 0.025% AH-8 arm received the lower dose of the study drug, Acetyl Hexapeptide 8 (AH-8), which is sold under the band name, Argireline.~Topical acetyl hexapeptide-8"
718036|NCT01750086|B2|Baseline|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
718012|NCT01750255|B2|Baseline|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment. Pharmaceutical Care: Patients and their families will be provided with verbal and written information and education about mental health and bipolar disorder.
718013|NCT01750255|B1|Baseline|Control|"There is no placebo treatment, and after randomization, patients were informed of their group assignments. The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families."
718014|NCT01750255|P2|Participant Flow|Intervention Group: the Dader Method for Pharmaceutical Care|The Dader Method for pharmaceutical care is a systematic process developed by the Research Group of Pharmaceutical Care at the University of Granada, Spain [16]. The intervention is based on the use of pharmacotherapy records, evaluation of an assessment form that includes BD-I and the drugs used to treat this medical problem, and their assessment on a specific date. This assessment is used to identify: (1) any potential or actual patient health outcomes that are not consistent with the objectives of pharmacotherapy and are associated with the use of medicines (negative outcomes associated with medication (NOM)); and (2) situations in which the use of medicines caused or may cause the appearance of a NOM (drug-related problems (DRP)) [14]. Once the relevant problems are identified, the necessary interventions to patients or to physicians are carried out to solve the identified NOM and are followed by a subsequent assessment of the achieved outcomes.
718015|NCT01750255|P1|Participant Flow|Control: Usual Care (Routine Dispensing), Verbal and Written|Because there is no blinding, there is no ‘placebo’ treatment. Patients who meet the inclusion criteria will be informed about the study and they will be registered after their signed authorization. The control group (patients and their families) will receive usual care as well as verbal and written information provided by the pharmacist (routine dispensing, including oral counseling regarding drugs). The written material is about mental health (MH) and BD, with information focusing on the importance of adhering to pharmacological and non-pharmacological interventions to achieve treatment goals. Randomization will take place during week zero (baseline) and patients will meet again with the pharmacist every three months (3, 6, 9, and 12 months). At each appointment, variables related to the primary (number of hospitalizations, emergency service consultations, unscheduled outpatient visits) and secondary outcomes (effectiveness, safety, adherence, and quality of life) will be assessed.
718016|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
718017|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
718018|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
718019|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
718020|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
718021|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
718022|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
718023|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
718024|NCT01750255|O2|Outcome|Intervention|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
718025|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
718026|NCT01750255|O2|Outcome|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
718027|NCT01750255|O1|Outcome|Control|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
718028|NCT01750255|E2|Reported Event|Pharmaceutical Care|Patients and families will be provided with verbal and written information and education about mental health and bipolar disorder. Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by certain criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy (Depression- Mania Rating Scale, Clinical Global Assessment Scale,Quality of life, adherence to treatment.
718029|NCT01750255|E1|Reported Event|Control|"The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life, adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.~Education: The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure d"
718030|NCT01750242|B1|Baseline|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
718031|NCT01750242|P1|Participant Flow|PD Patients Implanted With DBS System|Subjects implanted with Medtronic DBS system for the treatment of Parkinson's disease with leads in the subthalamic nucleus who consented for the study.
718032|NCT01750242|O1|Outcome|Subjects With Advanced Parkinson's Disease|Subjects with advanced Parkinson's Disease implanted with Medtronic DBS system and with documented improvement of at least 35% on UPDRS III from baseline preoperative off medication to post-DBS implant stimulation on/medication off.
718038|NCT01750086|P2|Participant Flow|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
718039|NCT01750086|P1|Participant Flow|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
718040|NCT01750086|O2|Outcome|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
718041|NCT01750086|O1|Outcome|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
718042|NCT01750086|E2|Reported Event|Alendronate 70mg Weekly x 8 Weeks|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
718043|NCT01750086|E1|Reported Event|Denosumab 60mg Subcutaneous Injection|"Each subject will receive one teriparatide 40-mcg subcutaneous injection at each study visit.~Teriparatide 40-mcg subcutaneous injection"
718044|NCT01749982|B5|Baseline|Total|Total of all reporting groups
718045|NCT01749982|B4|Baseline|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
718046|NCT01749982|B3|Baseline|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
718047|NCT01749982|B2|Baseline|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
718048|NCT01749982|B1|Baseline|Placebo|"Placebo tablets~Placebo"
718049|NCT01749982|P4|Participant Flow|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
718050|NCT01749982|P3|Participant Flow|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
718051|NCT01749982|P2|Participant Flow|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
718052|NCT01749982|P1|Participant Flow|Placebo|"Placebo tablets~Placebo"
718053|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
718054|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
718055|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
718056|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
718057|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
718058|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
718059|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
718060|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
718061|NCT01749982|O4|Outcome|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
718062|NCT01749982|O3|Outcome|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
718063|NCT01749982|O2|Outcome|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
718064|NCT01749982|O1|Outcome|Placebo|"Placebo tablets~Placebo"
718065|NCT01749982|E4|Reported Event|Choline Bitartrate + Betaine|"Choline bitartrate 700 mg + Betaine 1000 mg daily~Choline bitartrate + Betaine"
718066|NCT01749982|E3|Reported Event|Betaine|"Betaine 1000 mg by mouth daily~Betaine"
718067|NCT01749982|E2|Reported Event|Choline Bitartrate|"Choline bitartrate 700 mg by mouth daily~Choline bitartrate"
718068|NCT01749982|E1|Reported Event|Placebo|"Placebo tablets~Placebo"
718069|NCT01749956|B1|Baseline|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718070|NCT01749956|P1|Participant Flow|FOLFOX6/Aflibercept/Radation/Surgery|"Preoperative Chemoradiation (6 weeks): 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IV), Days 1-42; Radiation: 50.4 Gy (1.8 Gy/day) Mon-Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery (6 weeks from last dose of aflibercep): abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept: Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour; Days 1 and 15 of each 28-day cycle; Modified FOLFOX6: Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle; 5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle."
718071|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718072|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718073|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718074|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718075|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718076|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718077|NCT01749956|O1|Outcome|FOLFOX6/Aflibercept/Radiation/Surgery|Preoperative Chemoradiation (6 weeks) Surgery (6 weeks from last dose of aflibercept) Postoperative Chemotherapy and aflibercept (four 28-day cycles)
718121|NCT01748799|E7|Reported Event|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
718122|NCT01748799|E6|Reported Event|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed placebo
718078|NCT01749956|E1|Reported Event|FOLFOX6/Aflibercept/Radiation/Surgery|"Preoperative Chemoradiation: 5-FU: 225 mg/m2 per day by intravenous continuous infusion (IVCI), Days 1 thru 42; Radiation: 50.4 Gy (1.8 Gy/day or 28 fractions) Mon thru Fri, Weeks 1 thru 6; Aflibercept: 4 mg/ kg, via IV infusion, Days 1 and 15.~Surgery: Patients will undergo abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines.~Postoperative Chemotherapy and Aflibercept Treatments:~Aflibercept (administered first): 4 mg/kg IV for approximately 1 hour (no more than 2 hours) on Days 1 and 15 of each cycle.~Modified FOLFOX6:~Leucovorin: 400 mg/m2 as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~Oxaliplatin: 85 mg/m2 IV as a 2-hour infusion prior to 5-FU on Days 1 and 15 of each cycle.~5-FU: 400-mg/m2 bolus for 2 to 4 minutes followed by 2400 mg/m2 for 46 hours on Days 1 and 15 of each cycle.~Radiation~Aflibercept~Surgery: Abdominoperineal or low anterior resectio"
718079|NCT01748799|B9|Baseline|Total|Total of all reporting groups
718080|NCT01748799|B8|Baseline|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
718081|NCT01748799|B7|Baseline|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
718082|NCT01748799|B6|Baseline|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
718083|NCT01748799|B5|Baseline|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
718084|NCT01748799|B4|Baseline|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
718085|NCT01748799|B3|Baseline|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
718086|NCT01748799|B2|Baseline|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
718087|NCT01748799|B1|Baseline|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
718088|NCT01748799|P8|Participant Flow|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
718089|NCT01748799|P7|Participant Flow|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
718090|NCT01748799|P6|Participant Flow|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
718091|NCT01748799|P5|Participant Flow|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
718092|NCT01748799|P4|Participant Flow|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
718093|NCT01748799|P3|Participant Flow|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
718094|NCT01748799|P2|Participant Flow|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
718095|NCT01748799|P1|Participant Flow|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
718096|NCT01748799|O8|Outcome|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated Placebo
718097|NCT01748799|O7|Outcome|Self-titrated Placebo|Participants were requested to abstain from using cannabis and self-titrate dosages of placebo (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
718098|NCT01748799|O6|Outcome|Smoke as Usual FP|Smoke as usual condition corresponding to Fixed Placebo
718099|NCT01748799|O5|Outcome|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and administer a fixed dose of placebo daily (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
718100|NCT01748799|O4|Outcome|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
718101|NCT01748799|O3|Outcome|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
718102|NCT01748799|O2|Outcome|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
718103|NCT01748799|O1|Outcome|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
718104|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
718105|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
718106|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
718107|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
718108|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
718109|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
718110|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
718111|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
718112|NCT01748799|O8|Outcome|Sequence 8|Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
718113|NCT01748799|O7|Outcome|Sequence 7|Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
718114|NCT01748799|O6|Outcome|Sequence 6|Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
718115|NCT01748799|O5|Outcome|Sequence 5|Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
718116|NCT01748799|O4|Outcome|Sequence 4|Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
718117|NCT01748799|O3|Outcome|Sequence 3|Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
718118|NCT01748799|O2|Outcome|Sequence 2|Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
718119|NCT01748799|O1|Outcome|Sequence 1|Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
718120|NCT01748799|E8|Reported Event|Smoke as Usual StP|Smoke as usual condition corresponding to Self-titrated placebo
718123|NCT01748799|E5|Reported Event|Fixed Dose Placebo|Participants were requested to abstain from using cannabis and take a fixed dose of placebo during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
718124|NCT01748799|E4|Reported Event|Smoke as Usual StS|Smoke as usual condition corresponding to Self-titrated Sativex
718125|NCT01748799|E3|Reported Event|Self-titrated Sativex|Participants were requested to abstain from using cannabis and self-titrate dosages of Sativex (up to 40 sprays per day) during this condition. Each abstinence condition was followed by a smoke as usual condition (SAU).
718126|NCT01748799|E2|Reported Event|Smoke as Usual FS|Smoke as usual condition corresponding to Fixed Sativex
718127|NCT01748799|E1|Reported Event|Fixed Dose Sativex|Participants were requested to abstain from using cannabis and take a fixed dose of Sativex during this condition (40 sprays per day). Each abstinence condition was followed by a smoke as usual condition (SAU).
718128|NCT01748760|B3|Baseline|Total|Total of all reporting groups
718129|NCT01748760|B2|Baseline|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
718130|NCT01748760|B1|Baseline|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
718131|NCT01748760|P2|Participant Flow|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
718132|NCT01748760|P1|Participant Flow|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
718133|NCT01748760|O2|Outcome|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
718134|NCT01748760|O1|Outcome|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
718135|NCT01748760|E2|Reported Event|Treatment as Usual|"Adolescent participants and parents will not receive study intervention~Treatment as Usual: Referral to outpatient treatment as part of routine discharge planning."
718136|NCT01748760|E1|Reported Event|CLASP-A Intervention|"Adolescent participants and parents will receive adjunctive psychosocial intervention.~CLASP-A intervention: Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan."
718137|NCT01748695|B1|Baseline|V158866 and Placebo|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks or vice versa
718138|NCT01748695|P2|Participant Flow|V158866 Followed by Placebo|V158866 450mg once per day for 4 weeks followed by placebo once per day for 4 weeks
718139|NCT01748695|P1|Participant Flow|Placebo Followed by V158866|Placebo once per day for 4 weeks followed by V158866 450mg once per day for 4 weeks
718140|NCT01748695|O2|Outcome|V158866|V158866 450mg once per day for 4 weeks
718141|NCT01748695|O1|Outcome|Placebo|Placebo once per day for 4 weeks
718142|NCT01748695|O2|Outcome|V158866|V158866 450mg once per day for 4 weeks
718143|NCT01748695|O1|Outcome|Placebo|Placebo once per day for 4 weeks
718144|NCT01748695|E2|Reported Event|V158866|V158866 450mg once per day for 4 Weeks
718145|NCT01748695|E1|Reported Event|Placebo|Placebo once per day for 4 weeks
718146|NCT01749800|B4|Baseline|Total|Total of all reporting groups
718147|NCT01749800|B3|Baseline|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718148|NCT01749800|B2|Baseline|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718149|NCT01749800|B1|Baseline|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
718150|NCT01749800|P3|Participant Flow|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718151|NCT01749800|P2|Participant Flow|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718152|NCT01749800|P1|Participant Flow|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
718153|NCT01749800|O3|Outcome|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718154|NCT01749800|O2|Outcome|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718155|NCT01749800|O1|Outcome|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
718156|NCT01749800|E3|Reported Event|Armeo Spring + Sham GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with sham GVS. Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. Sham stimulation is delivered by connecting the subject to a device by A-M Systems, but the device is not active.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718157|NCT01749800|E2|Reported Event|Armeo Spring +GVS|"Subjects with both attention span deficits and significant motor impairments undergo robot-assisted upper-limb rehabilitation in combination with galvanic vestibular stimulation (GVS). Robot-assisted training is carried out using the Armeo Spring system by Hocoma AG. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Armeo Spring: A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises."
718158|NCT01749800|E1|Reported Event|Cognitive Test With/Without GVS|"Subjects with attention span deficits and no significant motor impairments undergo solely a cognitive test. The test is carried out in multiple trials. For some of the trials (randomly selected), subjects receive galvanic vestibular stimulation (GVS). For other trials, subjects received sham GVS. GVS is delivered using a device by A-M Systems.~GVS: A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.~Sham GVS: Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active."
718159|NCT01749735|B3|Baseline|Total|Total of all reporting groups
718160|NCT01749735|B2|Baseline|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718161|NCT01749735|B1|Baseline|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718162|NCT01749735|P2|Participant Flow|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718163|NCT01749735|P1|Participant Flow|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718164|NCT01749735|O2|Outcome|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718165|NCT01749735|O1|Outcome|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718166|NCT01749735|O2|Outcome|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718167|NCT01749735|O1|Outcome|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718168|NCT01749735|E2|Reported Event|Armeo Training With Sham tDCS|"Sham Transcranial Direct Current Stimulation: Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718169|NCT01749735|E1|Reported Event|Armeo Training With Continuous tDCS|"Transcranial Direct Current Stimulation: Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.~Armeo training: Upper extremity training with the use of a weight support device and virtual reality."
718170|NCT01749631|B1|Baseline|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718171|NCT01749631|P1|Participant Flow|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718172|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718173|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718174|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718175|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718176|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718177|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718178|NCT01749631|O1|Outcome|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718179|NCT01749631|E1|Reported Event|Difficult to Intubate (DTI) Participants|Male or non-pregnant females over 18 years of age with Mallampati score III or IV who were undergoing surgery using sevoflurane as the anesthetic agent as judged by the investigator and in compliance with the drug market authorization and approved product labeling.
718180|NCT01749605|B3|Baseline|Total|Total of all reporting groups
718181|NCT01749605|B2|Baseline|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
718182|NCT01749605|B1|Baseline|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
718183|NCT01749605|P2|Participant Flow|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
718184|NCT01749605|P1|Participant Flow|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
718185|NCT01749605|O2|Outcome|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
718186|NCT01749605|O1|Outcome|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
718187|NCT01749605|E2|Reported Event|Ciprofloxacin 250 mg|ciprofloxacin 250 mg BID x 3 days
718188|NCT01749605|E1|Reported Event|Nitrofurantoin 100 mg|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days
718189|NCT01749501|B3|Baseline|Total|Total of all reporting groups
718190|NCT01749501|B2|Baseline|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
718191|NCT01749501|B1|Baseline|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
718192|NCT01749501|P2|Participant Flow|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
718193|NCT01749501|P1|Participant Flow|Rocorium|"0.6 mg/kg once~Rocuronium: 0.6 mg/Kg once"
718194|NCT01749501|O2|Outcome|Placebo|Placebo: Normal saline same amt as 0.6mg/kg of study drug
718205|NCT01748955|B2|Baseline|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
718206|NCT01748955|B1|Baseline|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
718207|NCT01748955|P2|Participant Flow|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
718208|NCT01748955|P1|Participant Flow|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
718209|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
718210|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
718211|NCT01748955|O2|Outcome|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
718212|NCT01748955|O1|Outcome|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
718213|NCT01748955|E2|Reported Event|Paroxetine CR|"Participants will receive Paroxetine CR for 8 weeks.~Paroxetine CR for Major Depressive Episode: Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment."
718214|NCT01748955|E1|Reported Event|Bupropion|"Participants will receive bupropion XL for 8 weeks.~Bupropion XL for Major Depressive Episode: Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment."
718215|NCT01748916|B1|Baseline|All Groups (Average)|All study participants
718216|NCT01748916|P6|Participant Flow|Carrot-Tomato-Papaya|"Test meals were consumed in the following order: 1. Carrot 2. Tomato 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
718217|NCT01748916|P5|Participant Flow|Carrot-Papaya-Tomato|"Test meals were consumed in the following order: 1. Carrot 2. Papaya 3. Tomato~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
718218|NCT01748916|P4|Participant Flow|Tomato-Carrot-Papaya|"Test meals were consumed in the following order: 1. Tomato 2. Carrot 3. Papaya~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
718219|NCT01748916|P3|Participant Flow|Tomato-Papaya-Carrot|"Test meals were consumed in the following order: 1. Tomato 2. Papaya 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
718220|NCT01748916|P2|Participant Flow|Papaya-Tomato-Carrot|"Test meals were consumed in the following order: 1. Papaya 2. Tomato 3. Carrot~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
718221|NCT01748916|P1|Participant Flow|Papaya-Carrot-Tomato|"Test meals were consumed in the following order: 1. Papaya 2. Carrot 3. Tomato.~Papaya: Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Carrot: Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.~Tomato: Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread."
718222|NCT01748916|O5|Outcome|Lycopene Absorption From Tomato|
718223|NCT01748916|O4|Outcome|Lycopene Absorption From Papaya|
718224|NCT01748916|O3|Outcome|Beta-Carotene Absorption From Carrot|
718225|NCT01748916|O2|Outcome|Beta-Carotene Absorption From Tomato|
718226|NCT01748916|O1|Outcome|Beta-Carotene Absorption From Papaya|
718227|NCT01748916|E1|Reported Event|All Groups|All groups in study
718262|NCT01748071|E3|Reported Event|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
722970|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
718513|NCT01747655|P1|Participant Flow|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718228|NCT01748890|B1|Baseline|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
718229|NCT01748890|P1|Participant Flow|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
718230|NCT01748890|O1|Outcome|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
718231|NCT01748890|E1|Reported Event|Sonoelastography|"Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.~Sonoelastography: Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness."
718232|NCT01748227|B1|Baseline|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
718233|NCT01748227|P1|Participant Flow|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
718234|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
718235|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
718236|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
718237|NCT01748227|O1|Outcome|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
718238|NCT01748227|O1|Outcome|Pain Self-Management|"Peer delivery of pain self-management to veterans~Trained peers were each assigned 2 veterans to meet with regularly for 4 months and discuss pain self-management and coping strategies."
718239|NCT01748227|E1|Reported Event|Pain Self-Management|"Training of (veteran) peers to deliver pain self-management materials to veterans with chronic pain~Pain Self-Management: Training of veteran peers to deliver pain self-management material to veterans with chronic pain. Veteran peers will then be assigned 2 patients with chronic pain to work with over the next 4 months on pain self-management."
718240|NCT01748071|B4|Baseline|Total|Total of all reporting groups
718241|NCT01748071|B3|Baseline|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
718242|NCT01748071|B2|Baseline|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
718243|NCT01748071|B1|Baseline|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
718244|NCT01748071|P3|Participant Flow|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
718245|NCT01748071|P2|Participant Flow|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
718246|NCT01748071|P1|Participant Flow|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
718247|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
718248|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
718249|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
718250|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
718251|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
718252|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
718253|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
718254|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
718255|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
718256|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
718257|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
718258|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
718259|NCT01748071|O3|Outcome|Saline Group|Grouped by intravenous injection of saline before the time of anesthesia induction
718260|NCT01748071|O2|Outcome|Fentanyl Group|Grouped by intravenous injection of fentanyl at the time of anesthesia induction
718261|NCT01748071|O1|Outcome|Sufentanil Group|Grouped by intravenous injection of sufentanil at the time of anesthesia induction
722971|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
718266|NCT01747928|B8|Baseline|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718267|NCT01747928|B7|Baseline|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718268|NCT01747928|B6|Baseline|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718269|NCT01747928|B5|Baseline|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718270|NCT01747928|B4|Baseline|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718271|NCT01747928|B3|Baseline|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718272|NCT01747928|B2|Baseline|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718273|NCT01747928|B1|Baseline|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718274|NCT01747928|P8|Participant Flow|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718275|NCT01747928|P7|Participant Flow|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718276|NCT01747928|P6|Participant Flow|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718277|NCT01747928|P5|Participant Flow|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718278|NCT01747928|P4|Participant Flow|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718279|NCT01747928|P3|Participant Flow|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718280|NCT01747928|P2|Participant Flow|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718281|NCT01747928|P1|Participant Flow|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718282|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718283|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718284|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718285|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718286|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718287|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718288|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718289|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718290|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718291|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718292|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718293|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718294|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718295|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718296|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718297|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718298|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718299|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718300|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718301|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718302|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718303|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718304|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718305|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718306|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718307|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718308|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718309|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718310|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718311|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718312|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718313|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718314|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718315|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718316|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718317|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718318|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718319|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718320|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718321|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718322|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718323|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718324|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718325|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718326|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718327|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718328|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718329|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718330|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718331|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718332|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718333|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718334|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718335|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718336|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718337|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718338|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718339|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718340|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718341|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718342|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718343|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718344|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718345|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718346|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718347|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718348|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718349|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718350|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718351|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718352|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718353|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718354|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718355|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718356|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718357|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718358|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718359|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718360|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718361|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718362|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718363|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718364|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718365|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718366|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718367|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718368|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718369|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718370|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718371|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718372|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718373|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718374|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718375|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718376|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718377|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718378|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718379|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718380|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718381|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718382|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718383|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718384|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718385|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718386|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718387|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718388|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718389|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718390|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718391|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718392|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718393|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718394|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718395|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718396|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718397|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718398|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718399|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718400|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718401|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718402|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718403|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718404|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718405|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718406|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718407|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718408|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718409|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718410|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718411|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718412|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718413|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718414|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718415|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718416|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718417|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718418|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718419|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718420|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718421|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718422|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718423|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718424|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718425|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718426|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718427|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718428|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718429|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718430|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718431|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718432|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718433|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718434|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718435|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718436|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718437|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718438|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718439|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718440|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718441|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718442|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718443|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718444|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718445|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718446|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718447|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718448|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718449|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718450|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718451|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718452|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718453|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718454|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718455|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718456|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718457|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718458|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
718459|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718460|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718461|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718462|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718463|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718464|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718465|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718466|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718467|NCT01747928|O9|Outcome|All Participants|All participants who delivered a predefined dose and volume of alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse Dual Chamber Delivery System. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse Dual Chamber Delivery System.
718468|NCT01747928|O8|Outcome|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718469|NCT01747928|O7|Outcome|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718470|NCT01747928|O6|Outcome|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718471|NCT01747928|O5|Outcome|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718472|NCT01747928|O4|Outcome|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718512|NCT01747655|P2|Participant Flow|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718473|NCT01747928|O3|Outcome|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718474|NCT01747928|O2|Outcome|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718475|NCT01747928|O1|Outcome|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718476|NCT01747928|E8|Reported Event|Caverject 20 mcg Device - 20 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 20 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718477|NCT01747928|E7|Reported Event|Caverject 20 mcg Device - 15 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 15 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718478|NCT01747928|E6|Reported Event|Caverject 20 mcg Device - 10 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718479|NCT01747928|E5|Reported Event|Caverject 20 mcg Device - 5 mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718480|NCT01747928|E4|Reported Event|Caverject 10 mcg Device - 10 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 10 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718481|NCT01747928|E3|Reported Event|Caverject 10 mcg Device - 7.5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 7.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718482|NCT01747928|E2|Reported Event|Caverject 10 mcg Device - 5 mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Dual Chamber Delivery System to expel alprostadil 5.0 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718483|NCT01747928|E1|Reported Event|Caverject 10 mcg Device - 2.5 mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Dual Chamber Delivery System to expel alprostadil 2.5 mcg into a receptacle (rubber injection trainer). Participants did not receive study medication.
718484|NCT01747811|B3|Baseline|Total|Total of all reporting groups
718485|NCT01747811|B2|Baseline|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
718486|NCT01747811|B1|Baseline|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
718487|NCT01747811|P2|Participant Flow|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
718488|NCT01747811|P1|Participant Flow|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
718489|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
718490|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
718491|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
718492|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
718493|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
718494|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
718495|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
718496|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
718497|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-2 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
718498|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
718499|NCT01747811|O2|Outcome|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
718500|NCT01747811|O1|Outcome|Wavelength-1 Bright Light|"30 minutes daily light exposure for 6 weeks~wavelength-1 bright light: 6 weeks of daily light exposure, 30 minutes per morning"
718501|NCT01747811|E2|Reported Event|Wavelength-2 Bright Light|30 minutes daily light exposure for 6 weeks
718502|NCT01747811|E1|Reported Event|Wavelength-1 Bright Light|30 minutes daily light exposure for 6 weeks
718503|NCT01747772|B1|Baseline|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
718504|NCT01747772|P1|Participant Flow|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
718505|NCT01747772|O5|Outcome|Fibrosis 4|Participants with cirrhosis on liver biopsy evaluation.
718506|NCT01747772|O4|Outcome|Fibrosis 3|Participants with numerous septa without cirrhosis on liver biopsy evaluation.
718507|NCT01747772|O3|Outcome|Fibrosis 2|Participants with portal fibrosis with few septa on liver biopsy evaluation.
718508|NCT01747772|O2|Outcome|Fibrosis 1|Participants with portal fibrosis without septa on liver biopsy evaluation.
718509|NCT01747772|O1|Outcome|Fibrosis 0|Participants with no fibrosis on liver biopsy evaluation.
718510|NCT01747772|E1|Reported Event|Shear Wave Sonoelastography for Fibrosis Assessment|Shear Wave sonoelastography (SWE) was performed in patients who were scheduled for a non-focal liver biopsy.
718511|NCT01747655|B1|Baseline|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718514|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718515|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718516|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718517|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718518|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718519|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718520|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718521|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718522|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718523|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718524|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718525|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718526|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718527|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718528|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718529|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718530|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718531|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718532|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718533|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718534|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718535|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications.
718536|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718537|NCT01747655|O2|Outcome|Standard of Care|Participants that return to oral or transdermal anti-Parkinson's Disease medications
718538|NCT01747655|O1|Outcome|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy (PEG-J)
718539|NCT01747655|E1|Reported Event|Duodopa|Participants given Duodopa gel administered with a portable pump directly into the proximal small intestine by a jejunal extension tube of the percutaneous endoscopic gastrostomy
718540|NCT01747629|B3|Baseline|Total|Total of all reporting groups
718541|NCT01747629|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718542|NCT01747629|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718543|NCT01747629|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718544|NCT01747629|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718545|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718546|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718547|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718548|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718978|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718549|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718550|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718551|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718552|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718553|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718554|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718555|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718556|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718557|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718558|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718559|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718560|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718561|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718562|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718563|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718564|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718565|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718566|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718567|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718568|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718569|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718570|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718571|NCT01747629|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718572|NCT01747629|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718573|NCT01747629|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
718574|NCT01747629|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
718575|NCT01747343|B1|Baseline|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
718576|NCT01747343|P1|Participant Flow|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
718577|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
718578|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
718579|NCT01747343|O1|Outcome|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
718580|NCT01747343|E1|Reported Event|Underwear/Differential Reinforcement|All subjects will wear underwear followed by wearing underwear while receiving differential reinforcement.
718581|NCT01747330|B1|Baseline|Creon Micro, Minimicrospheres|Pancreatin: Doses of pancreatin <2500 lipase u/kg/feed or <4000 lipase u/g fat/intake or <10000 lipase u/kg/day given orally are used
718582|NCT01747330|P1|Participant Flow|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718583|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718584|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718585|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718586|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718587|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718588|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718589|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718590|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718591|NCT01747330|O1|Outcome|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718592|NCT01747330|E1|Reported Event|Creon Micro, Minimicrospheres|Pancreatin: Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
718593|NCT01746940|B5|Baseline|Total|Total of all reporting groups
718594|NCT01746940|B4|Baseline|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
718595|NCT01746940|B3|Baseline|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
718596|NCT01746940|B2|Baseline|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
718597|NCT01746940|B1|Baseline|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
718598|NCT01746940|P4|Participant Flow|Not Randomized|Enrolled subjects who are not randomized to treatment due to early withdrawal from the study
718599|NCT01746940|P3|Participant Flow|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
718600|NCT01746940|P2|Participant Flow|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
718601|NCT01746940|P1|Participant Flow|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
718602|NCT01746940|O3|Outcome|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
718603|NCT01746940|O2|Outcome|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
718604|NCT01746940|O1|Outcome|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
718605|NCT01746940|E3|Reported Event|Placebo Topical Solution|Subjects randomized to receive Placebo Topical Solution
718606|NCT01746940|E2|Reported Event|Cocaine HCl 10% Topical Solution|Subjects randomized to receive Cocaine HCl 10% Topical Solution
718607|NCT01746940|E1|Reported Event|Cocaine HCl 4% Topical Solution|Subjects randomized to receive Cocaine HCl 4% Topical Solution
718608|NCT01746862|B3|Baseline|Total|Total of all reporting groups
718609|NCT01746862|B2|Baseline|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718610|NCT01746862|B1|Baseline|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718611|NCT01746862|P2|Participant Flow|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718612|NCT01746862|P1|Participant Flow|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718613|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718614|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718615|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718616|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718617|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718618|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718619|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718620|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718621|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718622|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
722972|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
718855|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718623|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718624|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718625|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718626|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718627|NCT01746862|O2|Outcome|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718628|NCT01746862|O1|Outcome|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718629|NCT01746862|E2|Reported Event|Saizen Control Group|Subjects in the Saizen control group received no treatment for the first 6 months and thereafter received Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
718630|NCT01746862|E1|Reported Event|Saizen Test Group|Subjects in the Saizen test group received Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
718631|NCT01746784|B6|Baseline|Total|Total of all reporting groups
718632|NCT01746784|B5|Baseline|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718633|NCT01746784|B4|Baseline|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718634|NCT01746784|B3|Baseline|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718635|NCT01746784|B2|Baseline|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718636|NCT01746784|B1|Baseline|Normal Saline|Normal saline: IV solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
718637|NCT01746784|P5|Participant Flow|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718638|NCT01746784|P4|Participant Flow|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718639|NCT01746784|P3|Participant Flow|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718640|NCT01746784|P2|Participant Flow|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718641|NCT01746784|P1|Participant Flow|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
718642|NCT01746784|O5|Outcome|40mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022 in normal saline administered by infusion pump over 1-8 minutes"
718643|NCT01746784|O4|Outcome|20mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
718644|NCT01746784|O3|Outcome|10mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
718645|NCT01746784|O2|Outcome|5mg/N6022|"N6022 by IV infusion once per day for 7 days~N6022: Intravenous solution of N6022 in normal saline"
718646|NCT01746784|O1|Outcome|Normal Saline|Placebo will receive IV normal saline Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl
718647|NCT01746784|O5|Outcome|40mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718648|NCT01746784|O4|Outcome|20mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718649|NCT01746784|O3|Outcome|10mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718650|NCT01746784|O2|Outcome|5mg/N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718651|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
718652|NCT01746784|O5|Outcome|40mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718653|NCT01746784|O4|Outcome|20mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718654|NCT01746784|O3|Outcome|10mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718655|NCT01746784|O2|Outcome|5mg/N6022|N6022: Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes once per day for 7 days
718656|NCT01746784|O1|Outcome|Normal Saline|Normal saline: Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes
718657|NCT01746784|E5|Reported Event|40 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718658|NCT01746784|E4|Reported Event|20mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718659|NCT01746784|E3|Reported Event|10 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718660|NCT01746784|E2|Reported Event|5 mg/N6022|N6022 was administered by intravenous infusion once per day for 7 days
718661|NCT01746784|E1|Reported Event|Placebo/Saline|0.9% (weight/volume) NaCl was administered intravenously using the same volume as the active drug group.
718662|NCT01746511|B3|Baseline|Total|Total of all reporting groups
718790|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718663|NCT01746511|B2|Baseline|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718664|NCT01746511|B1|Baseline|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
718665|NCT01746511|P2|Participant Flow|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718666|NCT01746511|P1|Participant Flow|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
718667|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718668|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
718669|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718670|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
718681|NCT01746368|B1|Baseline|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
718791|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718671|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718672|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
718673|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718674|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
718675|NCT01746511|O2|Outcome|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718676|NCT01746511|O1|Outcome|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams."
718677|NCT01746511|E2|Reported Event|No Glycerin Suppository|"Infants will receive no scheduled glycerin suppositories, while under phototherapy (unless otherwise directed by attending physician).~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools."
718678|NCT01746511|E1|Reported Event|Glycerin Suppository|"Based on our institution's protocol, infant will receive a glycerin shave within one hour of initiation of phototherapy and then every eight hours while under phototherapy.~Subjects will be block randomized (varying block sizes of 2 to 8). Babies in both groups will be fed according to NICU standard birth weight protocols. Stratified enrollment will occur with 2 separate groups:~Infants who are NPO (< 20 mL/kg/day of fluids enterally at the time of therapy) vs.~Those being enterally fed at least 20 mL/kg/day of total fluids at the time of therapy.~Phototherapy: Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.~glycerin suppository: Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our"
718679|NCT01746368|B3|Baseline|Total|Total of all reporting groups
718680|NCT01746368|B2|Baseline|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
718682|NCT01746368|P2|Participant Flow|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
718683|NCT01746368|P1|Participant Flow|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
718684|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
718685|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
718686|NCT01746368|O2|Outcome|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
718687|NCT01746368|O1|Outcome|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
718688|NCT01746368|E2|Reported Event|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices. Subjects in this arm who desired information about risks, benefits, and alternatives of specific choices before randomization were scheduled for the Care-as-Usual session after they received that information from the Primary Care Provider.
718689|NCT01746368|E1|Reported Event|Nurse-Supported Advance Care Planning Intervention|The Nurse-Supported Advance Care Planning Intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
718690|NCT01746264|B1|Baseline|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718691|NCT01746264|P1|Participant Flow|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718692|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718693|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718694|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718695|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718696|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718697|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718698|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718699|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718700|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718701|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718702|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718703|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718704|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718705|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718706|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718707|NCT01746264|O1|Outcome|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718708|NCT01746264|E1|Reported Event|Vitamin D3|Vitamin D3 supplementation at 100,000 IU once a month for 3 months.
718709|NCT01746173|B1|Baseline|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
718792|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718710|NCT01746173|P1|Participant Flow|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
718711|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
718712|NCT01746173|O1|Outcome|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
718713|NCT01746173|E1|Reported Event|CHOEP + High Dose Therapy + Auto SCT|Patients received 6 cycles of induction chemotherapy: Cyclophosphamide, Doxorubicin, Vincristine, Etoposide and Prednisone (CHOEP) (5 if previously received 1 cycle of CHOP). CHOP was given at standard doses, with a dose of etoposide of 100 mg/m2 intravenously (IV) or 200 mg/m2 orally added on days 1-3 of each cycle. Patients who did not achieve a partial (PR) or complete (CR) remission at restaging after either 3 or 6 cycles were taken off study. Responders after 6 cycles had stem cell (SC) mobilization using filgrastim and plerixafor (if necessary) within 4 weeks of the end of induction. SC mobilization, harvesting, and reinfusion were performed per standard institutional protocol. A minimum collection of 2x106 CD34+ cells/kg was required to proceed to autologous stem cell transplant. Conditioning was comprised of gemcitabine 2700 mg/m2 on days -8 and -3, IV busulfan 105 mg/m2 days -8 to -5, and melphalan 60 mg/m2 given daily on days -3 and -2 (per MD Andersen protocol).
718714|NCT01746108|B4|Baseline|Total|Total of all reporting groups
718715|NCT01746108|B3|Baseline|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718716|NCT01746108|B2|Baseline|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718717|NCT01746108|B1|Baseline|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718718|NCT01746108|P3|Participant Flow|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718719|NCT01746108|P2|Participant Flow|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718720|NCT01746108|P1|Participant Flow|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718721|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718722|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718723|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718724|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718725|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718726|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718727|NCT01746108|O3|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718728|NCT01746108|O2|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718729|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718730|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
718731|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
718732|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
718733|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
718734|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718735|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
718736|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
718737|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718738|NCT01746108|O1|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
718739|NCT01746108|O2|Outcome|Synflorix AR- UN-5-17Y Group|Subset of the AR- UN-5-17Y Group including subjects aged between 5 and 17 years.
718740|NCT01746108|O1|Outcome|Synflorix AR-PR-5-17Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 5 and 17 years.
718741|NCT01746108|O2|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
718742|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718743|NCT01746108|O3|Outcome|Synflorix AR-Un-2-4Y Group|Subset of the AR-UN-2-17Y Group including subjects aged between 24 and 59 months.
718744|NCT01746108|O2|Outcome|Synflorix AR-PR-2-4Y Group|Subset of the AR-PR-2-17Y Group including subjects aged between 24 and 59 months.
718745|NCT01746108|O1|Outcome|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718767|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718768|NCT01745952|O1|Outcome|Any Difference Between the Four Conditions|effect of baseline/ figure-of-eight/ round/ sham treatment period on the seizure frequency of the patients
718853|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718746|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718747|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718748|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718749|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718750|NCT01746108|O1|Outcome|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718751|NCT01746108|O1|Outcome|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718752|NCT01746108|E3|Reported Event|Synflorix AR-Un-2-17Y Group|"Unprimed (Un) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 2 doses of SynflorixTM vaccine: Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718753|NCT01746108|E2|Reported Event|Synflorix HE-Un-2-4Y Group|Healthy (HE) unprimed (Un) subjects, aged between 24 and 59 months of age (age-matched to the subjects aged 24-59 months in the At risk groups), receiving 2 doses of SynflorixTM vaccine. Unprimed groups included subjects who have not been previously vaccinated with any pneumococcal vaccine, i.e. either plain polysaccharide pneumococcal vaccine, SynflorixTM, PrevenarTM or Prevenar13TM. For each enrolled at-risk subject aged between 24-59 months, a healthy subject of the same age expressed in years from the same country should be enrolled regardless of the priming status (i.e.: a healthy subject could be enrolled only once if he/she could be matched with an unmatched at-risk subject of the same age and country).
718789|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718754|NCT01746108|E1|Reported Event|Synflorix AR-Pr-2-17Y Group|"Primed (Pr) subjects aged between 24 months and 17 years, who were at an increased risk (AR) of pneumococcal infection*, receiving 1 dose of SynflorixTM vaccine: Primed groups included subjects who have been previously vaccinated with at least one dose of a pneumococcal conjugate vaccine, i.e. either SynflorixTM, PrevenarTM or Prevenar13TM or with plain polysaccharide pneumococcal vaccine more than 2 years (24 months) and less than 5 years (60 months) before enrolment.~*An at-risk subject was a subject with Congenital or acquired asplenia such as anatomic, surgical or functional asplenia, or Splenic dysfunction [some degree of functional asplenia, such as sickle-cell disease and other hemoglobinopathies, Hodgkin disease, rheumatologic diseases, systemic lupus erythematous (SLE), chronic gastrointestinal disorders, liver disease, infiltrative disorders, vascular disorder etc.] or Complement deficiencies, e.g.C1-C4, C5-C9, properdin factor H or factor D."
718755|NCT01745952|B1|Baseline|All Participants|description of the patients at the onset of the study
718756|NCT01745952|P3|Participant Flow|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718757|NCT01745952|P2|Participant Flow|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718758|NCT01745952|P1|Participant Flow|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718759|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718760|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718761|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718762|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718763|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718764|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718765|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718766|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718769|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718770|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718771|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718772|NCT01745952|O3|Outcome|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
718773|NCT01745952|O2|Outcome|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered"
718774|NCT01745952|O1|Outcome|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~All patients who have undergone this treatment are taken together, irrespective of order the other treatments were administered."
718775|NCT01745952|O3|Outcome|Sham Coil; Then Figure-of-eight Active Coil; Then Round Active|"rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718776|NCT01745952|O2|Outcome|Round Active Coil; Then Sham; Then Figure-of-eight Active Coil|"rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718777|NCT01745952|O1|Outcome|Figure-of-eight Active Coil; Then Round Active Coil; Then Sham|"rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period~rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~12 week follow-up period"
718778|NCT01745952|E3|Reported Event|Sham rTMS Coil (Figure-of-eight)|"rTMS is administered using the figure-of-eight sham coil, over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~sham rTMS coil (figure-of-eight): placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue"
718779|NCT01745952|E2|Reported Event|Round Active rTMS Coil|"rTMS is administered using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~round active rTMS coil: navigated rTMS over epileptogenic focus using round active rTMS coil"
718780|NCT01745952|E1|Reported Event|Figure-of-eight Active rTMS Coil|"rTMS is administered using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, at 0.5 Hertz with a total of 1500 pulses per day, during weekdays on two consecutive weeks.~figure-of-eight active rTMS coil: navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil"
718781|NCT01745380|B3|Baseline|Total|Total of all reporting groups
718782|NCT01745380|B2|Baseline|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718783|NCT01745380|B1|Baseline|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718784|NCT01745380|P2|Participant Flow|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718785|NCT01745380|P1|Participant Flow|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718786|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718787|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718788|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718793|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718794|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718795|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718796|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718797|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718798|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718799|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718800|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718801|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718802|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718803|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718804|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718805|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718806|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718807|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718808|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718809|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718810|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718811|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718812|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718813|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718814|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718815|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718816|NCT01745380|O2|Outcome|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718817|NCT01745380|O1|Outcome|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718818|NCT01745380|E2|Reported Event|Placebo|"Placebo - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Placebo"
718819|NCT01745380|E1|Reported Event|Kovacaine Mist|"Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 2 sprays will be administered at the start of the procedure, if anesthesia is insufficient, a third spray will be administered.~Tetracaine HCl 3% and Oxymetazoline HCl 0.05%"
718820|NCT01745133|B4|Baseline|Total|Total of all reporting groups
718821|NCT01745133|B3|Baseline|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
718822|NCT01745133|B2|Baseline|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
722973|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
718823|NCT01745133|B1|Baseline|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
718824|NCT01745133|P3|Participant Flow|Calcipotriene + Clobetasol Propionate 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
718825|NCT01745133|P2|Participant Flow|Calcipotriene 20|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
718826|NCT01745133|P1|Participant Flow|Vehicle 19|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
718827|NCT01745133|O3|Outcome|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
718828|NCT01745133|O2|Outcome|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
718829|NCT01745133|O1|Outcome|Vehicle 68%|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
718830|NCT01745133|E3|Reported Event|Calcipotriene + Clobetasol Propionate 79%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays for 8 weeks + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks~calcipotriene + clobetasol propionate: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks"
718831|NCT01745133|E2|Reported Event|Calcipotriene 80%|"clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks x~calcipotriene: clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks"
718832|NCT01745133|E1|Reported Event|Vehicle|"clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks~vehicle foam: clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks"
718833|NCT01745055|B1|Baseline|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718834|NCT01745055|P1|Participant Flow|Methotrexate + CP-690,550|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice); followed by CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6; followed by single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718835|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718836|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
718837|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718838|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
718839|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718840|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
718841|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718842|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
718843|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718844|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
718845|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718846|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
718847|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718848|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
718849|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718850|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
718851|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718852|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
718856|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of methotrexate (MTX) on Day 1 (15-25 milligram [mg], as per local prescribing practice).
718857|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718858|NCT01745055|O1|Outcome|Methotrexate|Single oral dose of MTX on Day 1 (15-25 milligram [mg], as per local prescribing practice).
718859|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718860|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
718861|NCT01745055|O2|Outcome|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718862|NCT01745055|O1|Outcome|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
718863|NCT01745055|E3|Reported Event|Methotrexate + CP-690,500|Single oral dose of MTX (15-25 mg, as per local prescribing practice) and single oral dose of CP-690,500 30 mg tablet orally, on Day 7.
718864|NCT01745055|E2|Reported Event|CP-690,500|CP-690,500 30 mg tablet orally every twelve hours from Day 3 to Day 6.
718865|NCT01745055|E1|Reported Event|Methotrexate|Single oral dose of MTX on Day 1 (15-25 mg), as per local prescribing practice.
718866|NCT01744977|B3|Baseline|Total|Total of all reporting groups
718867|NCT01744977|B2|Baseline|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
718868|NCT01744977|B1|Baseline|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
718869|NCT01744977|P2|Participant Flow|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
718870|NCT01744977|P1|Participant Flow|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA (Research Assistant) on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
718871|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
718872|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
718873|NCT01744977|O2|Outcome|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
718874|NCT01744977|O1|Outcome|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
718875|NCT01744977|E2|Reported Event|Education Only Group|Control Arm patients will receive primary care and LDL management according to the discretion of their provider. At baseline, patients will receive similar written information on how to obtain medication refills and the importance of taking their cholesterol medications as prescribed.
718876|NCT01744977|E1|Reported Event|Adherence Packaging Intervention Group|"[MeadWestvaco Packaging Intervention Arm] At baseline, the intervention arm will receive instructions from the RA on obtaining medication refills and the first fill of their statin medication from the VA pharmacy. At this time, the pharmacist will provide counseling including 1) use of adherence packaging, 2) to only use statin medications from the adherence packaging 3) purpose of LDL-related medications 4) how to take the medications.~packaging: Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles"
718877|NCT01744860|B1|Baseline|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
722974|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
718981|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718878|NCT01744860|P1|Participant Flow|Melanoma Tumor Sample With BRAF V600 Mutation|BRAF V600 mutations were analysed in melanoma tumor samples using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods and Cobas 4800 mutation test
718879|NCT01744860|O1|Outcome|Final Result- Discordant Samples|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
718880|NCT01744860|O1|Outcome|Discordant Group|This included 28 samples out of 420 samples, whose BRAF V600 mutation results, by INCa “in House” Methods and cobas 4800 BRAF V600 mutation test did not show similar outcome.
718881|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
718882|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
718883|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
718884|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
718885|NCT01744860|O1|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
718886|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718887|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718888|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718889|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718890|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718891|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718892|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718893|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718894|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718895|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718896|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718897|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718898|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718899|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718900|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718901|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718902|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718903|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718904|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “In-house” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods.
718905|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
718906|NCT01744860|O1|Outcome|Overall Tumour Samples|A total of 420 melanoma samples (surgical specimens or biopsies of primary tumours or metastases) were included in analysis. The samples were collected either from External pathology laboratories or Internal pathology laboratories
718907|NCT01744860|O2|Outcome|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
718979|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718908|NCT01744860|O1|Outcome|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using “in-house” methods
718909|NCT01744860|E2|Reported Event|Cobas 4800 Mutation Test|BRAF V600 mutations were analysed using Cobas 4800 mutation test
718910|NCT01744860|E1|Reported Event|INCa Molecular Genetics Laboratory “in House” Methods|BRAF V600 mutations were analysed using INCa (Institut National du Cancer [French National Cancer Institute]) molecular genetics laboratories using in-house methods
718911|NCT01744821|B5|Baseline|Total|Total of all reporting groups
718912|NCT01744821|B4|Baseline|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
718913|NCT01744821|B3|Baseline|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
718914|NCT01744821|B2|Baseline|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718915|NCT01744821|B1|Baseline|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718916|NCT01744821|P4|Participant Flow|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
718917|NCT01744821|P3|Participant Flow|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
718918|NCT01744821|P2|Participant Flow|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718919|NCT01744821|P1|Participant Flow|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718920|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
718921|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
718922|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718923|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718924|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
718925|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
718926|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718927|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718928|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
718929|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
718930|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718931|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718932|NCT01744821|O4|Outcome|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
718933|NCT01744821|O3|Outcome|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
718934|NCT01744821|O2|Outcome|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718935|NCT01744821|O1|Outcome|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718936|NCT01744821|E4|Reported Event|Placebo 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to Placebo p.o. daily until surgery (levels will be rechecked every 4 weeks)
718937|NCT01744821|E3|Reported Event|Vitamin D 2,000 IU Daily|If Vitamin D level is>30ng/ml at baseline, randomized to 2000 IU p.o. daily until surgery (levels will be rechecked every 4 week)
718938|NCT01744821|E2|Reported Event|Placebo 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to Placebo p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718939|NCT01744821|E1|Reported Event|Vitamin D 50,000 IU Weekly|If Vitamin D level is ≤ 30ng/ml at baseline, randomized to 50,000 IU p.o. weekly until surgery (levels will be rechecked every 4 weeks)
718940|NCT01744730|B6|Baseline|Total|Total of all reporting groups
718941|NCT01744730|B5|Baseline|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
718942|NCT01744730|B4|Baseline|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718980|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
719890|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
718943|NCT01744730|B3|Baseline|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718944|NCT01744730|B2|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718945|NCT01744730|B1|Baseline|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718946|NCT01744730|P5|Participant Flow|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration.
718947|NCT01744730|P4|Participant Flow|Clindamycin IV-ages 12 to 17 (BMI Greater Than 95th)|Clindamycin IV: Children ages 12 to 17 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718948|NCT01744730|P3|Participant Flow|Clinidamycin IV-ages 12 to 17 (BMI 85-95th Percentile)|Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718949|NCT01744730|P2|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI Greater Than 95th)|Clindamycin IV: Children ages 2 to 11 years old with BMI greater than 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718950|NCT01744730|P1|Participant Flow|Clindamycin IV-ages 2 to 11 Years Old (BMI 85-95th Percentile)|Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.
718951|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718952|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718953|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718954|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718955|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718956|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718957|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718958|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718959|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718960|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718961|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718962|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718963|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718964|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718965|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718966|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718967|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718968|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718969|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718970|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718971|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718972|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718973|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718974|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718975|NCT01744730|O6|Outcome|Clindamycin- Age >12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718976|NCT01744730|O5|Outcome|Clindamycin- Age >12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718977|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
722975|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
718983|NCT01744730|O4|Outcome|Clindamycin- Ages >6 to 12 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718984|NCT01744730|O3|Outcome|Clindamycin- Ages >6 to 12 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718985|NCT01744730|O2|Outcome|Clindamycin- Ages >2 to 6 Years Old (Obese)|Obese patients were those with BMI greater to or equal to the 85th percentile.
718986|NCT01744730|O1|Outcome|Clindamycin- Ages >2 to 6 Years Old (Non-Obese)|Non-obese patients were those with BMI <85th percentile.
718987|NCT01744730|E5|Reported Event|Patients Less Than 21 Years of Age (NCT01431326)|Standard of care clindamycin administration
718988|NCT01744730|E4|Reported Event|Clindamycin IV-ages 12 to 17 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 12 to 17 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
718989|NCT01744730|E3|Reported Event|Clinidamycin IV-ages 12 to 17 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 12 to 17 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
718990|NCT01744730|E2|Reported Event|Clindamycin IV-ages 2 to 11 (BMI Greater Than or Equal 95th)|"Clindamycin IV: Children ages 2 to 11 years old with BMI greater than or equal 95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
718991|NCT01744730|E1|Reported Event|Clindamycin IV-ages 2 to 11 (BMI 85- <95th Percentile)|"Clindamycin IV: Children ages 2 to 11 years old with BMI 85th to <95th percentile. Their schedule of IV Clindamycin administration included 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day was allowed for children receiving clindamycin as part of clinical care.~Clindamycin PO: Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 g/day. Dosing greater than 2.7 g/day was allowed for children receiving clindamycin as part of clinical care."
718992|NCT01744691|B1|Baseline|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
718993|NCT01744691|P1|Participant Flow|Ibrutinib|"All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.~Ibrutinib: All subjects received ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
718994|NCT01744691|O1|Outcome|PCI-32765|"All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects will receive PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
718995|NCT01744691|O1|Outcome|Ibrutinib|"All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.~ibrutinib: All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily."
718996|NCT01744691|E1|Reported Event|PCI-32765|"All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily.~PCI-32765: All subjects received PCI-32765 420 mg (3 x 140-mg capsules) orally once daily."
718997|NCT01744496|B3|Baseline|Total|Total of all reporting groups
718998|NCT01744496|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
718999|NCT01744496|B1|Baseline|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719000|NCT01744496|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719025|NCT01744483|O3|Outcome|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
719029|NCT01744483|E2|Reported Event|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
719030|NCT01744483|E1|Reported Event|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
719001|NCT01744496|P1|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719002|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719003|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719004|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719005|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719006|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719007|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719008|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719009|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719026|NCT01744483|O2|Outcome|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
719027|NCT01744483|O1|Outcome|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
719028|NCT01744483|E3|Reported Event|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
719010|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719011|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719012|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719013|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719014|NCT01744496|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719015|NCT01744496|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719016|NCT01744496|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine: Patches contained 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication started at the Baseline Visit. Rotigotine was administered once daily starting at 4 mg / 24 h. Doses were then up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) was reached and the Maintenance Period could be started. The duration of the Titration Period varied from 1 to 7 weeks ± 3 days. The Maintenance Period lasted 12 weeks ± 5 days. Thereafter, during the De-Escalation Period, the dose of study medication was decreased by 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719017|NCT01744496|E1|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo: Placebo patches matched the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and contained Placebo. Application of Placebo patches started at the Baseline Visit. Placebo patches were administered once daily starting with the equivalent of 4 mg / 24 h. Doses were then up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose was reached. The maximum dose was the equivalent to 16 mg / 24 h. The duration of the Titration Period varied from 1 to 7 weeks. The Maintenance Period lasted 12 weeks ± 5 days. During the De-Escalation Period, the dose of Placebo was decreased by the equivalent to 2 mg / 24 h every other day. The De-Escalation Period might have lasted up to 12 days."
719018|NCT01744483|B4|Baseline|Total|Total of all reporting groups
719019|NCT01744483|B3|Baseline|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
719020|NCT01744483|B2|Baseline|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
719021|NCT01744483|B1|Baseline|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
719022|NCT01744483|P3|Participant Flow|PUC-CASS ETT|"Polyurethane cuff with continuous aspiration of subglottic secretions endotracheal tube~PUC-CASS ETT: Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation."
719023|NCT01744483|P2|Participant Flow|PUC ETT|"Polyurethane cuff endotracheal tube~PUC ETT: Placement of a PUC-cuffed ETT in the setting of emergent intubation."
719024|NCT01744483|P1|Participant Flow|PVC ETT|"Polyvinylchloride cuff endotracheal tube~PVC ETT: Placement of a PVC-cuffed ETT in the setting of emergent intubation."
719031|NCT01744392|B1|Baseline|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719032|NCT01744392|P1|Participant Flow|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719033|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719034|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719035|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719036|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719037|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719052|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
719053|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
719054|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
719038|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719039|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719040|NCT01744392|O1|Outcome|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~Education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719041|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
719042|NCT01744392|O1|Outcome|Education Intervention|The intervention provides a personalized Meducation calendar to all patients enrolled in the study. The Meducation Calendar includes medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication. Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study. The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
719043|NCT01744392|E1|Reported Event|Education Intervention|"The intervention provides a personalized Meducation calendar to all patients enrolled in the study (identified in package as Example Calendar). The Meducation Calendar will include medications for diabetes (sugar), high blood pressure, cholesterol, heart medications and blood thinning medications. The medication calendars contains the following for each medication 1) the name, 2) the time of day, including a pictorial display, it should be taken 3) the number of times each day to take the medication, and 4) the indication for the medication.~education intervention: Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development."
719044|NCT01744353|B4|Baseline|Total|Total of all reporting groups
719045|NCT01744353|B3|Baseline|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
719046|NCT01744353|B2|Baseline|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
719047|NCT01744353|B1|Baseline|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
719048|NCT01744353|P3|Participant Flow|Experimental: Dose Level 3|Abraxane 175 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
719049|NCT01744353|P2|Participant Flow|Experimental: Dose Level 2/ MTD|Abraxane 150 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
719050|NCT01744353|P1|Participant Flow|Experimental: Dose Level 1|Abraxane 125 mg/m2, day 1 Oxaliplatin 85 mg/m2, day 1 leucovorin 400 mg/m2, day 1 5-FU Infusion 1200 mg/m2/ days 2 days IV infusion
719051|NCT01744353|O3|Outcome|Experimental: Dose Level 3|"Drug: Dose level 3 Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxan"
719076|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
719055|NCT01744353|O2|Outcome|Experimental: Dose Level 2/ MTD|"Drug: Dose level 2/MTD Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
719056|NCT01744353|O1|Outcome|Experimental: Dose Level 1|"Drug: Dose level 1 Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion~Other Names:~5-FU infusion, leuocovorin, oxaliplatin, Abraxane"
719057|NCT01744353|E1|Reported Event|FOLFOX- A|"FOLFOX-A Dose levels -1, 1, 2, 3: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue until level 3 provided that the MTD has not been reached. If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If dose level 1 is not tolerable then dose level -1 will be investigated. Once the MTD is found, the Principal Investigator will determine which dose should be assessed futher and an additional 10 patients will be treated.~FOLFOX-A: Three patients will be accrued to level 1. If no dose limiting toxicities (defined in section 5.2) are observed after two cycles of treatment, then accrual to level 2 will proceed. This procedure will continue un"
719058|NCT01744340|B3|Baseline|Total|Total of all reporting groups
719059|NCT01744340|B2|Baseline|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719060|NCT01744340|B1|Baseline|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719061|NCT01744340|P2|Participant Flow|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719062|NCT01744340|P1|Participant Flow|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719063|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719064|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719065|NCT01744340|O2|Outcome|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719066|NCT01744340|O1|Outcome|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719067|NCT01744340|E2|Reported Event|Colon- Closed as of May 2014|"Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle~Colon- Closed as of May 2014: Eribulin Mesylate:~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719068|NCT01744340|E1|Reported Event|Head and Neck|"Cetuximab, 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly there after Eribulin Mesylate 1.4mg/m2~Head and neck: Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
719069|NCT01744197|B3|Baseline|Total|Total of all reporting groups
719070|NCT01744197|B2|Baseline|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
719071|NCT01744197|B1|Baseline|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
719072|NCT01744197|P2|Participant Flow|Placebo First, Then Synera|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received placebo patch for the first application (day 1), and then Synera for the second (day 2 or after).
719073|NCT01744197|P1|Participant Flow|Synera First, Then Placebo|Synera (lidocaine 70mg/tetracaine 70mg): All subjects received 2 patch applications, one Synera and one placebo. These 2 patch applications were done on separate days. Subjects in this arm received Synera patch for the first application (day 1), and then placebo for the second (day 2 or after).
719074|NCT01744197|O2|Outcome|Placebo|Treated with Placebo.
719075|NCT01744197|O1|Outcome|Synera|Treated with Synera.
719083|NCT01743963|B2|Baseline|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
719894|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719084|NCT01743963|B1|Baseline|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
719085|NCT01743963|P2|Participant Flow|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
719086|NCT01743963|P1|Participant Flow|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
719087|NCT01743963|O2|Outcome|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
719088|NCT01743963|O1|Outcome|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
719089|NCT01743963|E2|Reported Event|Usual Care|"Clinicians' typical approach for GID monitoring~Usual Care: clinicians typical apporach for GID monitering"
719090|NCT01743963|E1|Reported Event|Decision Support Intervention|"Clinical pharmacists mediated computerized decision support~Decision support: Clinical pharmacists mediated computerized decision support"
719091|NCT01743729|B3|Baseline|Total|Total of all reporting groups
719092|NCT01743729|B2|Baseline|Placebo|
719093|NCT01743729|B1|Baseline|Lifitegrast|
719094|NCT01743729|P2|Participant Flow|Placebo|
719095|NCT01743729|P1|Participant Flow|Lifitegrast|
719096|NCT01743729|O2|Outcome|Placebo|
719097|NCT01743729|O1|Outcome|Lifitegrast|
719098|NCT01743729|O2|Outcome|Placebo|
719099|NCT01743729|O1|Outcome|Lifitegrast|
719100|NCT01743729|E2|Reported Event|Placebo|
719101|NCT01743729|E1|Reported Event|Lifitegrast|
719102|NCT01743521|B5|Baseline|Total|Total of all reporting groups
719103|NCT01743521|B4|Baseline|No Group Allocated|Early treatment discontinuation or non-responder
719104|NCT01743521|B3|Baseline|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719105|NCT01743521|B2|Baseline|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719106|NCT01743521|B1|Baseline|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719107|NCT01743521|P4|Participant Flow|No Group Allocated|Early treatment discontinuation or non-responder (participants in whom therapy was terminated at week 4 due to HCV RNA >1000 IU/mL or week 8 due to detectable HCV RNA)
719108|NCT01743521|P3|Participant Flow|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719109|NCT01743521|P2|Participant Flow|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719110|NCT01743521|P1|Participant Flow|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719111|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719189|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719200|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719112|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719113|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719114|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719115|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719116|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719117|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719118|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719119|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719120|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719121|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719122|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719190|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719191|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719192|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719123|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719124|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719125|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719126|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719127|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719128|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719129|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719130|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719131|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719132|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719133|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719193|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719194|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719134|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719135|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719136|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719137|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719138|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719139|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719140|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719141|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719142|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719143|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719144|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719195|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719196|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719145|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719146|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719147|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719148|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719149|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719150|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719151|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719152|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719153|NCT01743521|O3|Outcome|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719154|NCT01743521|O2|Outcome|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719155|NCT01743521|O1|Outcome|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719197|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719198|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719199|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719156|NCT01743521|E3|Reported Event|Group C - 24 Weeks Total Therapy|"24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719157|NCT01743521|E2|Reported Event|Group B - 12 Weeks Total Therapy|"12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719158|NCT01743521|E1|Reported Event|Group A - 8 Weeks Total Therapy|"8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy~TPV/PEG-IFN/RBV: Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
719159|NCT01743092|B3|Baseline|Total|Total of all reporting groups
719160|NCT01743092|B2|Baseline|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
719161|NCT01743092|B1|Baseline|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
719162|NCT01743092|P2|Participant Flow|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
719163|NCT01743092|P1|Participant Flow|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
719164|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
719165|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
719166|NCT01743092|O2|Outcome|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
719167|NCT01743092|O1|Outcome|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
719168|NCT01743092|E2|Reported Event|Tutorial Workbook Group Plus Webinar|"Tutorial Workbook Group plus webinar will receive in addition, a webinar as an additional resource.~Webinar: Some clients will receive a webinar as part of their treatment.~Tutuorial workbook: A work book about their addiciton"
719169|NCT01743092|E1|Reported Event|Tutorial Workbook|"Tutorial Workbook Group only receives a Tutorial Workbook Group~Tutuorial workbook: A work book about their addiciton"
719170|NCT01743027|B5|Baseline|Total|Total of all reporting groups
719171|NCT01743027|B4|Baseline|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719172|NCT01743027|B3|Baseline|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719173|NCT01743027|B2|Baseline|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719174|NCT01743027|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719175|NCT01743027|P4|Participant Flow|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719176|NCT01743027|P3|Participant Flow|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719177|NCT01743027|P2|Participant Flow|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719178|NCT01743027|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719179|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719180|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719181|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719182|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719183|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719184|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719185|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719186|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719187|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719188|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
722976|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
719201|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719202|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719203|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719204|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719205|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719206|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719207|NCT01743027|O4|Outcome|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719208|NCT01743027|O3|Outcome|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719209|NCT01743027|O2|Outcome|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719210|NCT01743027|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719211|NCT01743027|E4|Reported Event|Vehicle|AL-4943A ophthalmic solution vehicle, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719212|NCT01743027|E3|Reported Event|PATANOL|Olopatadine hydrochloride ophthalmic solution, 0.1%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719213|NCT01743027|E2|Reported Event|PATADAY|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719214|NCT01743027|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop per eye Day 0, followed by 1 drop per eye Day 14
719215|NCT01742936|B3|Baseline|Total|Total of all reporting groups
719216|NCT01742936|B2|Baseline|Cardiac Bypass|"Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
719217|NCT01742936|B1|Baseline|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek: Hand held coagulation monitor.~Hospital Laboratory: Coagulation testing done by hospital laboratory."
719218|NCT01742936|P2|Participant Flow|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
719219|NCT01742936|P1|Participant Flow|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
719220|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
719221|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
719222|NCT01742936|O2|Outcome|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
719223|NCT01742936|O1|Outcome|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
719224|NCT01742936|E2|Reported Event|Cardiac Bypass|Patients undergoing surgery requiring cardiopulmonary bypass and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.
719225|NCT01742936|E1|Reported Event|Spinal Fusion|"Patients undergoing a posterior spinal fusion and having clotting factors checked by both hand held CoaguChek and Hospital Laboratory.~CoaguChek~Hospital Laboratory"
719226|NCT01742897|B1|Baseline|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
719227|NCT01742897|P1|Participant Flow|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
719228|NCT01742897|O1|Outcome|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
719229|NCT01742897|E1|Reported Event|TTS-Fentanyl|Transdermal therapeutic system (TTS) fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches were replaced every 3 days until 30 days.
719230|NCT01742832|B3|Baseline|Total|Total of all reporting groups
719231|NCT01742832|B2|Baseline|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
719232|NCT01742832|B1|Baseline|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
719233|NCT01742832|P2|Participant Flow|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
719271|NCT01742364|E1|Reported Event|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719309|NCT01741792|O1|Outcome|Blinatumomab 9 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day.
719234|NCT01742832|P1|Participant Flow|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
719235|NCT01742832|O2|Outcome|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
719236|NCT01742832|O1|Outcome|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
719237|NCT01742832|E2|Reported Event|Citalopram|"For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.~Citalopram: For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day."
719238|NCT01742832|E1|Reported Event|Vilazodone|"A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.~Vilazodone: A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day."
719239|NCT01742364|B5|Baseline|Total|Total of all reporting groups
719240|NCT01742364|B4|Baseline|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719241|NCT01742364|B3|Baseline|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719242|NCT01742364|B2|Baseline|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719243|NCT01742364|B1|Baseline|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719244|NCT01742364|P4|Participant Flow|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719245|NCT01742364|P3|Participant Flow|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719246|NCT01742364|P2|Participant Flow|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719247|NCT01742364|P1|Participant Flow|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719248|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719249|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719250|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719251|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719252|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719253|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719254|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719255|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719256|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719257|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719258|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719259|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719260|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719261|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719262|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719263|NCT01742364|O1|Outcome|Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719264|NCT01742364|O4|Outcome|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719265|NCT01742364|O3|Outcome|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719266|NCT01742364|O2|Outcome|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719267|NCT01742364|O1|Outcome|INFANTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719268|NCT01742364|E4|Reported Event|ADULTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719269|NCT01742364|E3|Reported Event|ADULTS: Bioject Intradermal (ID) Pen|"Intradermal administration of BCG vaccine via the Bioject ID Pen.~Bioject ID Pen"
719270|NCT01742364|E2|Reported Event|INFANTS: Needle and Syringe|"Intradermal administration of BCG vaccine via needle and syringe.~Needle and syringe"
719272|NCT01741792|B4|Baseline|Total|Total of all reporting groups
719273|NCT01741792|B3|Baseline|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719274|NCT01741792|B2|Baseline|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719275|NCT01741792|B1|Baseline|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719276|NCT01741792|P3|Participant Flow|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719277|NCT01741792|P2|Participant Flow|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719278|NCT01741792|P1|Participant Flow|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719279|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719280|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719281|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719282|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719283|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719284|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719285|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719286|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719287|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719288|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719289|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719290|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719291|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719292|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719293|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719294|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719295|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719296|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719297|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719298|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719299|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719300|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719301|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719302|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719303|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719304|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719305|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719306|NCT01741792|O1|Outcome|Blinatumomab|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719307|NCT01741792|O3|Outcome|Blinatumomab 112 μg/d|Participants received blinatumomab administered CIV 112 µg/day.
719310|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719311|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719312|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719313|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719314|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719315|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719316|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719317|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719318|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719319|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719320|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719321|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719322|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719323|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719324|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719541|NCT01740817|E2|Reported Event|Intralipid|Saline infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then Intralipid 30 ml/h for 48 h
719601|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719325|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719326|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719327|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719328|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719329|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719330|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719331|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719332|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719333|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719334|NCT01741792|O3|Outcome|Cohort 3: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719335|NCT01741792|O2|Outcome|Cohort 2: Blinatumomab 112 μg/d|Participants received blinatumomab CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719336|NCT01741792|O1|Outcome|Cohort 1: Blinatumomab 9/28/112 μg/d|Participants received blinatumomab administered via a continuous intravenous infusion (CIV) 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a complete response (CR) or partial response (PR), or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719337|NCT01741792|E5|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
719338|NCT01741792|E4|Reported Event|Cohort 1+3: Blinatumomab 9/28/112µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719339|NCT01741792|E3|Reported Event|Cohort 3: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719340|NCT01741792|E2|Reported Event|Cohort 2: Blinatumomab 112 µg/d|Participants received blinatumomab administered CIV at a constant dose of 112 µg/day for 8 weeks of treatment during Cycle 1. Participants who achieved CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719542|NCT01740817|E1|Reported Event|Saline|Intralipid infusion 20%, at 30 ml/h for 48 h, then washout 4-6 weeks, then saline 30 ml/h for 48 h
719543|NCT01740726|B3|Baseline|Total|Total of all reporting groups
719341|NCT01741792|E1|Reported Event|Cohort 1: Blinatumomab 9/28/112 µg/d|Participants received blinatumomab administered CIV 9 µg/day for the first week, followed by 28 µg/day for the second week, then 112 µg/day for the remaining 6 weeks of treatment during Cycle 1. Participants who achieved a CR or PR, or had stable disease after the first treatment cycle were eligible to receive a second (consolidation) cycle of treatment over 4 weeks, following a 4-week treatment-free interval.
719342|NCT01741701|B3|Baseline|Total|Total of all reporting groups
719343|NCT01741701|B2|Baseline|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719344|NCT01741701|B1|Baseline|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719345|NCT01741701|P2|Participant Flow|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719346|NCT01741701|P1|Participant Flow|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719347|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719348|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719349|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719350|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719351|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719352|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719353|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719354|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719355|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719356|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719357|NCT01741701|O2|Outcome|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719358|NCT01741701|O1|Outcome|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719359|NCT01741701|E2|Reported Event|Placebo|"placebo capsules that contain only 100 mg ascorbate, taken daily~Placebo"
719360|NCT01741701|E1|Reported Event|Oxaloacetate (OAA)|"active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily~Oxaloacetate (OAA)"
719361|NCT01741688|B1|Baseline|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719362|NCT01741688|P1|Participant Flow|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719363|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719364|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719365|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719366|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719367|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719368|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719369|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719370|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719600|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719371|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719372|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719373|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719374|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719375|NCT01741688|O1|Outcome|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719376|NCT01741688|O1|Outcome|Cohort|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719377|NCT01741688|E1|Reported Event|Tocilizumab|"Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), in whom the attending physician has decided to start treatment with tocilizumab (according to the local label).~Tocilizumab: Tocilizumab was administered according to the local label."
719378|NCT01741350|B3|Baseline|Total|Total of all reporting groups
719379|NCT01741350|B2|Baseline|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719380|NCT01741350|B1|Baseline|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719381|NCT01741350|P2|Participant Flow|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719382|NCT01741350|P1|Participant Flow|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719383|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719544|NCT01740726|B2|Baseline|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
719384|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719385|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719386|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719387|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719388|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719389|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719390|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719391|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719545|NCT01740726|B1|Baseline|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
719546|NCT01740726|P2|Participant Flow|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
719392|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719393|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719394|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719395|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719396|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719397|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719398|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719399|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719547|NCT01740726|P1|Participant Flow|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
719548|NCT01740726|O2|Outcome|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
719400|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719401|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719402|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719403|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719404|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719405|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719406|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719407|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719549|NCT01740726|O1|Outcome|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
719550|NCT01740726|E2|Reported Event|Fluoxetine|Fluoxetine: Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
719408|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719409|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719410|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719411|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719412|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719413|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719414|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719415|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719551|NCT01740726|E1|Reported Event|Behavioral Activation|Behavioral Activation: 18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
719552|NCT01740713|B4|Baseline|Total|Total of all reporting groups
719553|NCT01740713|B3|Baseline|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719763|NCT01738971|E1|Reported Event|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
719416|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719417|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719418|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719419|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719420|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719421|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719422|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719423|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719554|NCT01740713|B2|Baseline|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719555|NCT01740713|B1|Baseline|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719556|NCT01740713|P3|Participant Flow|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719557|NCT01740713|P2|Participant Flow|Deferiprone 50 mg/kg/da|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719424|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719425|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719426|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719427|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719428|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719429|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719430|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719431|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719558|NCT01740713|P1|Participant Flow|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719559|NCT01740713|O1|Outcome|Safety Population|patients who may experience adverse events occurred before or after treatment
719560|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719561|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719432|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719433|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719434|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719435|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719436|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719437|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719438|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719439|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719562|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719563|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719564|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719565|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719440|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719441|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719442|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719443|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719444|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719445|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719446|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719447|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719566|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719567|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719568|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719569|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
719448|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719449|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719450|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719451|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719452|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719453|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719454|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719455|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719570|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719571|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719572|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719573|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
719456|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719457|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719458|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719459|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719460|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719461|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719462|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719463|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719574|NCT01740713|O3|Outcome|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719575|NCT01740713|O2|Outcome|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719576|NCT01740713|O1|Outcome|Deferiprone 25 mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719577|NCT01740713|O1|Outcome|PK Population|Deferiprone liquid oral solution (80 mg/ml) has been administered at 25/50/100 mg/kg/day
719464|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719465|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719466|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719467|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719468|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719469|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719470|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719471|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719578|NCT01740713|E3|Reported Event|Deferiprone 100 mg/kg/Day|"Deferiprone will be administered at 100 mg/kg/day~Deferiprone, dose level 3: deferiprone liquid oral solution (80 mg/ml)"
719579|NCT01740713|E2|Reported Event|Deferiprone 50 mg/kg/Day|"Deferiprone will be administered at 50 mg/kg/day~Deferiprone, dose level 2: deferiprone liquid oral solution (80 mg/ml)"
719580|NCT01740713|E1|Reported Event|Deferiprone 25mg/kg/Day|"Deferiprone will be administered at 25 mg/kg/day~Deferiprone, dose level 1: deferiprone liquid oral solution (80 mg/ml)"
719581|NCT01740440|B1|Baseline|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
719764|NCT01738919|B3|Baseline|Total|Total of all reporting groups
719472|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719473|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719474|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719475|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719476|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719477|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719478|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719479|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719582|NCT01740440|P1|Participant Flow|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
719583|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
719584|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face: BMR Face used in accordance with manufacturer IFU"
719585|NCT01740440|O1|Outcome|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
719586|NCT01740440|E1|Reported Event|BMR Face Treatment|"BMR Face treatment used once a day for 12 weeks~BMR Face"
719587|NCT01740427|B3|Baseline|Total|Total of all reporting groups
719480|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719481|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719482|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719483|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719484|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719485|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719486|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719487|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719588|NCT01740427|B2|Baseline|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719589|NCT01740427|B1|Baseline|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719590|NCT01740427|P2|Participant Flow|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
722977|NCT01725984|E2|Reported Event|AdVance XP|Subjects implanted with the AdVance XP Male Sling
719488|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719489|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719490|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719491|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719492|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719493|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719494|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719495|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719591|NCT01740427|P1|Participant Flow|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719592|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719593|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719496|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719497|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719498|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719499|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719500|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719501|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719502|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719503|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719594|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719595|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719596|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
722978|NCT01725984|E1|Reported Event|AdVance|Subjects implanted with the AdVance Male Sling
719504|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719505|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719506|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719507|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719508|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719509|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719510|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719511|NCT01741350|O2|Outcome|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition : Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719597|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719598|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719599|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
722979|NCT01725529|B4|Baseline|Total|Total of all reporting groups
719512|NCT01741350|O1|Outcome|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program : Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719513|NCT01741350|E2|Reported Event|Control Condition|"The time-and-attention-matched control condition for the proposed research will be a time and contact-matched, non-contaminating support group for individuals in recovery modeled after similar groups offered in the community. There will be no overlap between the content of the comparison intervention and experimental intervention although the basic structure will be the same. Thus, each participant will be asked to attend four 50-minute weekly group sessions led by two trained facilitators. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Time-and-Attention-Matched Control Condition: Four weekly support groups and routine clinical services (i.e., daily methadone and case management)."
719514|NCT01741350|E1|Reported Event|CHRP Group|"Patients assigned to Community-friendly Health Recovery Program (CHRP) will receive a weekly HIV risk reduction group level intervention led by two facilitators trained and supervised by the PI, a licensed clinical psychologist. The CHRP intervention is a substantially shortened version of the comprehensive Holistic Health Recovery Program (HHRP)-based interventions that have been identified as demonstrating evidence of effectiveness in two randomized clinical trials. The CHRP, which includes four 50-minute groups (1 group per week), will contain only content that relates explicitly to drug- or sex-related HIV risk reduction. Participants in both conditions will receive routine clinical services (i.e., daily methadone and case management).~Community-friendly Health Recovery Program: Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management)."
719515|NCT01741272|B3|Baseline|Total|Total of all reporting groups
719516|NCT01741272|B2|Baseline|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719517|NCT01741272|B1|Baseline|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719518|NCT01741272|P2|Participant Flow|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719519|NCT01741272|P1|Participant Flow|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719520|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719521|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719522|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719523|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719524|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719525|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719526|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719527|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719528|NCT01741272|O2|Outcome|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719529|NCT01741272|O1|Outcome|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719530|NCT01741272|E2|Reported Event|Group B (Early ROM)|"Will use the sling for comfort only. Intervention: Procedure: No sling~No sling: Patients may discontinue use of the sling as early as pain and comfort allow. Early active ROM is allowed for activities of daily living."
719531|NCT01741272|E1|Reported Event|Group A (Usual Care)|"Will be immobilized in a sling for 6 weeks. Intervention: Procedure: Sling~Sling: Patients will use a sling for 6 weeks as per usual care. No active ROM allowed."
719532|NCT01740817|B1|Baseline|All Study Participants|Participants who were randomized to receive either lipid or saline
719533|NCT01740817|P2|Participant Flow|Saline Then Lipid|Saline infusion 30 ml/h for 48 h, then lipid 30 ml/h for 48 h
719534|NCT01740817|P1|Participant Flow|Lipid Then Saline|Intralipid 20% 30 ml/h for 48 h, then saline 30 ml/h for 48 h
719535|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
719536|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
719537|NCT01740817|O2|Outcome|Intralipid|liposyn infusion at 30 ml/h for 48 hrs
719538|NCT01740817|O1|Outcome|Saline|Saline infusion at 30 ml/h for 48 h
719602|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719603|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719604|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719605|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719606|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719607|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719608|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719609|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719610|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719611|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719612|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719613|NCT01740427|O2|Outcome|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719614|NCT01740427|O1|Outcome|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719615|NCT01740427|E2|Reported Event|Placebo Plus Letrozole|Participants received letrozole 2.5 mg orally QD combined with placebo QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719616|NCT01740427|E1|Reported Event|Palbociclib Plus Letrozole|Participants received letrozole 2.5 milligram (mg) orally QD (once daily) combined with palbociclib 125 mg QD for 21 days of every-28-day cycle, followed by 7 days off treatment.
719617|NCT01740401|B1|Baseline|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
719618|NCT01740401|P1|Participant Flow|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
719619|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
719620|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
719621|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
719767|NCT01738919|P2|Participant Flow|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
719644|NCT01740362|B4|Baseline|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719622|NCT01740401|O1|Outcome|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
719623|NCT01740401|E1|Reported Event|Cyclophosphamide, Ipilimumab|"Treatment:~Cyclophosphamide 300 mg/m^2 po - Day 1 of Weeks 1, 4, 7, and 10, for a total of 4 doses; (premedication prior to each dose of Cyclophosphamide 8mg Zofran po, then prn)~Ipilimumab 10 mg/kg iv - Day 3 of Weeks 1, 4, 7, and 10 for a total of 4 doses Maintenance treatment will be given on Weeks 24, 36, and 48 Ipilimumab 10 mg/kg iv~Cyclophosphamide, Ipilimumab: This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimuab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study"
719624|NCT01740388|B3|Baseline|Total|Total of all reporting groups
719625|NCT01740388|B2|Baseline|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719626|NCT01740388|B1|Baseline|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719627|NCT01740388|P2|Participant Flow|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719628|NCT01740388|P1|Participant Flow|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719629|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719630|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719631|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719632|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719633|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719634|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719635|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719636|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719637|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719638|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719639|NCT01740388|O2|Outcome|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719640|NCT01740388|O1|Outcome|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719641|NCT01740388|E2|Reported Event|Vehicle|"vehicle of besifloxacin ophthalmic suspension administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Vehicle: one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days."
719642|NCT01740388|E1|Reported Event|Besifloxacin|"besifloxacin ophthalmic suspension 0.6% administered 2 times daily (BID) for 3 days to participants with a clinical diagnosis of bacterial conjunctivitis~Besifloxacin: one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days."
719643|NCT01740362|B5|Baseline|Total|Total of all reporting groups
719645|NCT01740362|B3|Baseline|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719646|NCT01740362|B2|Baseline|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719647|NCT01740362|B1|Baseline|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719648|NCT01740362|P4|Participant Flow|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719649|NCT01740362|P3|Participant Flow|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719650|NCT01740362|P2|Participant Flow|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719651|NCT01740362|P1|Participant Flow|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719652|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719653|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719654|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719655|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719656|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719657|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719658|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719659|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719660|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719661|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719662|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719663|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719664|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719665|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719666|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719667|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719668|NCT01740362|O4|Outcome|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719669|NCT01740362|O3|Outcome|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719670|NCT01740362|O2|Outcome|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719671|NCT01740362|O1|Outcome|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719672|NCT01740362|E4|Reported Event|CP-690,550 (Severe Renal Insufficiency)|Participants with severe renal insufficiency who had creatinine clearance <30 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719673|NCT01740362|E3|Reported Event|CP-690,550 (Moderate Renal Insufficiency)|Participants with moderate renal insufficiency who had creatinine clearance >=30 mL/min but =<50 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719674|NCT01740362|E2|Reported Event|CP-690,550 (Mild Renal Insufficiency)|Participants with mild renal insufficiency who had creatinine clearance >50 mL/min but less than or equal to (=<) 80 mL/min, received single oral dose of CP-690,550 tablet 10 mg orally.
719675|NCT01740362|E1|Reported Event|CP-690,550 (Normal Renal Function)|Participants with normal renal function who had creatinine clearance greater than (>) 80 milliliter/minute (mL/min), received single oral dose of CP-690,550 tablet 10 milligram (mg) orally.
719676|NCT01740089|B4|Baseline|Total|Total of all reporting groups
719677|NCT01740089|B3|Baseline|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
719678|NCT01740089|B2|Baseline|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719679|NCT01740089|B1|Baseline|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719680|NCT01740089|P3|Participant Flow|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
719681|NCT01740089|P2|Participant Flow|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719682|NCT01740089|P1|Participant Flow|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719683|NCT01740089|O2|Outcome|PegIntron (n=50)|
719684|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
719685|NCT01740089|O2|Outcome|PegIntron (n=50)|
719686|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
719687|NCT01740089|O2|Outcome|PegIntron (n=50)|
719688|NCT01740089|O1|Outcome|Algeron (n=100)|the comparative inter-group analysis of efficacy was performed for patients of groups 1 and 2 received Algeron (n=100), because after 12 weeks of therapy and analysis of data, all patients of the first and second groups continued receive Algeron in a chosen therapeutic dose 1.5 µg/kg.
719689|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
719690|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719691|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719692|NCT01740089|O3|Outcome|PegIntron|"PegIntron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~PegIntron: 1.5 μg/kg/week subcutaneously in combination with ribavirin"
719693|NCT01740089|O2|Outcome|Algeron 2.0 μg/kg|"Algeron 2.0 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719694|NCT01740089|O1|Outcome|Algeron 1.5 μg/kg|"Algeron 1.5 μg/kg of body weight weekly subcutaneously in combination with ribavirin daily orally in a daily dose of 800 mg (patients with body weight < 65 kg), 1000 mg (patients with body weight of 65-85 kg inclusive), 1200 mg (patients with body weight of 86-105 kg inclusive) or 1400 mg (patients with body weight > 105 kg).~Algeron: 1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously"
719695|NCT01740089|E2|Reported Event|PegIntron (n=50)|
719768|NCT01738919|P1|Participant Flow|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
719696|NCT01740089|E1|Reported Event|Algeron (n=101)|The safety analysis included 101 patients received at least 1 dose of Algeron (taking into account one patient withdrawn at early stages of the study due to a protocol violation [severe depression by the Beck's scale before the first injection], who was withdrawn from the mITT-analysis)
719697|NCT01739803|B3|Baseline|Total|Total of all reporting groups
719698|NCT01739803|B2|Baseline|Control Group|No intervention
719699|NCT01739803|B1|Baseline|Intervention Group|Behavioral contract intervention
719700|NCT01739803|P2|Participant Flow|Control Group|"No intervention.~The control group received standard specialty pharmacy care, which included mail or telephone reminders of monthly medication refills and an adherence packet consisting of adherence-focused educational pamphlets and a pillbox"
719701|NCT01739803|P1|Participant Flow|Intervention Group|"Behavioral contract intervention.~Each participant in the intervention group met with the study pharmacist to negotiate and sign an immunosuppressant therapy (IST) adherence contract at baseline. Each intervention participant met with the study pharmacist at 3-, 6-, and 9-months post-enrollment to review his or her contract, discuss progress toward reaching the contract's goal of achieving the highest possible IST adherence, update terms of the contract if needed, and re-sign the contract for the next three-month period. At the 12-month post-enrollment meeting, the contract was terminated.~The contract included: (a) motivation(s) for achieving adherence; (b) barriers that may interfere with achieving adherence and possible solutions to overcome barriers; (c) social support available such as a significant other who may assist in following the dosing schedule; (d) tools/strategies to follow the dosing schedule; and (e) possible consequences of nonadherence"
719702|NCT01739803|O2|Outcome|Control Group|No intervention
719703|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
719704|NCT01739803|O2|Outcome|Control Group|No intervention
719705|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
719706|NCT01739803|O2|Outcome|Control Group|No intervention
719707|NCT01739803|O1|Outcome|Intervention Group|Behavioral contract intervention
719708|NCT01739803|E2|Reported Event|Control Group|No intervention
719709|NCT01739803|E1|Reported Event|Intervention Group|Behavioral contract intervention
719710|NCT01739595|B4|Baseline|Total|Total of all reporting groups
719711|NCT01739595|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
719712|NCT01739595|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719713|NCT01739595|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719714|NCT01739595|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
719715|NCT01739595|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719716|NCT01739595|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719717|NCT01739595|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
719718|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719719|NCT01739595|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719720|NCT01739595|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
719721|NCT01739595|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719722|NCT01739595|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
719723|NCT01739361|B3|Baseline|Total|Total of all reporting groups
719724|NCT01739361|B2|Baseline|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
719725|NCT01739361|B1|Baseline|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
719726|NCT01739361|P2|Participant Flow|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
719727|NCT01739361|P1|Participant Flow|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
719728|NCT01739361|O2|Outcome|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
719729|NCT01739361|O1|Outcome|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
719730|NCT01739361|E2|Reported Event|Placebo|"Patients will receive placebo by mouth or by enteral feeding tube every six hours for 72 hours.~placebo"
719731|NCT01739361|E1|Reported Event|Acetaminophen|"Patients will receive acetaminophen at the dose of 1 gram by mouth or by enteral feeding tube every six hours for a total of 72 hours.~Acetaminophen"
719732|NCT01738984|B3|Baseline|Total|Total of all reporting groups
719733|NCT01738984|B2|Baseline|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
719765|NCT01738919|B2|Baseline|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
719766|NCT01738919|B1|Baseline|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
719734|NCT01738984|B1|Baseline|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
719735|NCT01738984|P2|Participant Flow|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
719736|NCT01738984|P1|Participant Flow|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
719737|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
719738|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
719739|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
719740|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
719741|NCT01738984|O2|Outcome|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
719742|NCT01738984|O1|Outcome|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
719743|NCT01738984|E2|Reported Event|Standard Exercise DVD|"Exercise DVD that demonstrates yoga or strengthening exercises a mother can perform with her infant.~Standard Exercise DVD: Standard exercise DVD that demonstrates exercises a women does with an infant."
719744|NCT01738984|E1|Reported Event|MomZing Web Program|"Features include selection one to three 10-minute videos demonstrating yoga, aerobics, and strengthening, specifically designed for mothers with infants 2 to 8 months of age. Women will sequence together videos personalized to their fitness level, preference for exercise type, and a choice to actively exercise with her baby or alone. Exercises with a baby will be tailored to the infant's weight and include interactions that promote cognitive development and mother-child bonding.~MomZing Web Program: Online web platform that is accessed via a television connected to internet"
719745|NCT01738971|B4|Baseline|Total|Total of all reporting groups
719746|NCT01738971|B3|Baseline|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
719747|NCT01738971|B2|Baseline|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
719748|NCT01738971|B1|Baseline|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
719749|NCT01738971|P3|Participant Flow|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
719750|NCT01738971|P2|Participant Flow|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
719751|NCT01738971|P1|Participant Flow|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
719752|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
719753|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
719754|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
719755|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
719756|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
719757|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
719758|NCT01738971|O3|Outcome|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
719759|NCT01738971|O2|Outcome|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
719760|NCT01738971|O1|Outcome|Control (Standard Care)|standard verbal and written advice on contraception from pharmacy
719761|NCT01738971|E3|Reported Event|Progestogen Only Pill|"one month progestogen only pill~one month progestogen only pill"
719762|NCT01738971|E2|Reported Event|Rapid Access|"rapid access to family planning service~rapid access to contraceptive service"
719770|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
719771|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
719772|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
719773|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
719774|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
719775|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
719776|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
719777|NCT01738919|O2|Outcome|Non-subluxated - Operation|Operative treatment with extension block technique
719778|NCT01738919|O1|Outcome|Non-subluxated - Splinting|Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used.
719779|NCT01738919|O2|Outcome|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique: Surgery with extension block technique. 6 weeks."
719780|NCT01738919|O1|Outcome|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
719781|NCT01738919|E2|Reported Event|Non-subluxated - Operation|"Operative treatment with extension block technique~Operative treatment with extension block technique"
719782|NCT01738919|E1|Reported Event|Non-subluxated - Splinting|"Conservative treatment with splinting for 6 weeks.~Conservative treatment with splinting for 6 weeks.: Aluminum Karstam splints are used."
719783|NCT01738750|B3|Baseline|Total|Total of all reporting groups
719784|NCT01738750|B2|Baseline|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
719785|NCT01738750|B1|Baseline|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
719786|NCT01738750|P2|Participant Flow|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
719787|NCT01738750|P1|Participant Flow|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
719788|NCT01738750|O2|Outcome|No Dollar Information Included|Group of patients that will not receive dollar information for the laparoscopic and open surgical procedures prior to choice of procedure.
719789|NCT01738750|O1|Outcome|Dollar Information Included|"Group of patients that will receive dollars information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Dollars Information Included"
719790|NCT01738750|O2|Outcome|No Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
719791|NCT01738750|O1|Outcome|Cost Information Included|Percentage of Participants who Choose Open Appendectomy or Laparoscopic Appendectomy
719792|NCT01738750|E2|Reported Event|No Cost Information Included|Group of patients that will not receive cost information for the laparoscopic and open surgical procedures prior to choice of procedure.
719793|NCT01738750|E1|Reported Event|Cost Information Included|"Group of patients that will receive cost information for both the laparoscopic and open surgical procedures prior to choice of procedure.~Cost Information Included"
719794|NCT01738737|B6|Baseline|Total|Total of all reporting groups
719795|NCT01738737|B5|Baseline|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719796|NCT01738737|B4|Baseline|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
719797|NCT01738737|B3|Baseline|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719798|NCT01738737|B2|Baseline|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
719799|NCT01738737|B1|Baseline|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719800|NCT01738737|P5|Participant Flow|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719801|NCT01738737|P4|Participant Flow|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)"
719802|NCT01738737|P3|Participant Flow|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 9 points of application of active laser per knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719803|NCT01738737|P2|Participant Flow|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 9 points of application of placebo laser per knee (frontal faces, lateral and medial)"
719804|NCT01738737|P1|Participant Flow|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719805|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719806|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
719807|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719808|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
719809|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719810|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719811|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
719812|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719813|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
719814|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719815|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719816|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
719817|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719818|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
719819|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719820|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719821|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
719822|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719823|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
719824|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719825|NCT01738737|O5|Outcome|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719826|NCT01738737|O4|Outcome|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
719827|NCT01738737|O3|Outcome|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719828|NCT01738737|O2|Outcome|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
719829|NCT01738737|O1|Outcome|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719830|NCT01738737|E5|Reported Event|Control|Control group that will receive a small book with informations about knee osteoarthritis and postural orientation.
719831|NCT01738737|E4|Reported Event|Active Laser|"Application of active laser only during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)"
719832|NCT01738737|E3|Reported Event|Stretching|"Seven stretching exercises for lower limbs during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719888|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719889|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719833|NCT01738737|E2|Reported Event|Placebo Laser + Stretching|"application of placebo laser therapy during nine sessions plus stretching exercises during 24 sessions~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions~placebo laser therapy: 18 points of application of placebo laser in the knee (frontal faces, lateral and medial)"
719834|NCT01738737|E1|Reported Event|Active Laser + Stretching|"application of active laser therapy during nine sessions plus stretching exercises during 24 sessions~Active Laser: 18 points of application of active laser in the knee (frontal faces, lateral and medial)~Stretching exercises: 7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions"
719835|NCT01738698|B5|Baseline|Total|Total of all reporting groups
719836|NCT01738698|B4|Baseline|Placebo|Placebo: Oral administration once-daily for 12 weeks
719837|NCT01738698|B3|Baseline|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719838|NCT01738698|B2|Baseline|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719839|NCT01738698|B1|Baseline|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719840|NCT01738698|P4|Participant Flow|Placebo|Placebo: Oral administration once-daily for 12 weeks
719841|NCT01738698|P3|Participant Flow|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719842|NCT01738698|P2|Participant Flow|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719843|NCT01738698|P1|Participant Flow|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719844|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719845|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719846|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719847|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719848|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719849|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719850|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719851|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719852|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719853|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719854|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719855|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719856|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719857|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719858|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719859|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719860|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719861|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719862|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719863|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719864|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719865|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719866|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719867|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719868|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719869|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719870|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719871|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719872|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719873|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719874|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719875|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719876|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719877|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719878|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719879|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719880|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719881|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719882|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719883|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719884|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719885|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719886|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719887|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719891|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719892|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719893|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719895|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719896|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719897|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719898|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719899|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719900|NCT01738698|O4|Outcome|Placebo|Placebo: Oral administration once-daily for 12 weeks
719901|NCT01738698|O3|Outcome|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719902|NCT01738698|O2|Outcome|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719903|NCT01738698|O1|Outcome|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719904|NCT01738698|E4|Reported Event|Placebo|Placebo: Oral administration once-daily for 12 weeks
719905|NCT01738698|E3|Reported Event|SPD489 160mg|SPD489 160mg: Oral administration of 160 mg once-daily for up to 12 weeks
719906|NCT01738698|E2|Reported Event|SPD489 100mg|SPD489 100mg: Oral administration of 100 mg once-daily for up to 12 weeks
719907|NCT01738698|E1|Reported Event|SPD489 40mg|SPD489 40mg: Oral administration of 40 mg once-daily for up to 12 weeks
719908|NCT01738646|B1|Baseline|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
719909|NCT01738646|P1|Participant Flow|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
719910|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
719911|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
719912|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
719913|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|"Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.~Vorinostat~Bevacizumab"
719914|NCT01738646|O1|Outcome|Vorinostat & Bevacizumab|Patients will be administered bevacizumab every 2 weeks and vorinostat will be taken on days 1-7 and 15-21 of each 28-day cycle at 400 mg per day.
719915|NCT01738646|E1|Reported Event|Vorinostat & Bevacizumab|Patients will be evaluated for adverse events (all grades), serious adverse events, and adverse events requiring study drug interruption or discontinuation at each study visit for the duration of their participation in the study.
719916|NCT01738581|B3|Baseline|Total|Total of all reporting groups
719917|NCT01738581|B2|Baseline|rTMS + CTL, rTMS + Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation (rTMS) with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion for the first phase, then rTMS with sensorimotor retraining.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719918|NCT01738581|B1|Baseline|rTMS + Sensorimotor Retraining, rTMS + CTL|"Repetitive transcranial magnetic (rTMS) stimulation and sensorimotor retraining for the first phase, then rTMS with control therapy (CTL). CTL therapy was non-specific therapy that includes stretching, massage, range of motion.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719919|NCT01738581|P2|Participant Flow|rTMS + CTL, Then rTMS + SMR|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719920|NCT01738581|P1|Participant Flow|rTMS + SMR, Then rTMS + CTL|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719921|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719922|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719923|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719924|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
720020|NCT01737931|P3|Participant Flow|No-treatment|No treatment to the application sites after the patch removal
719925|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
720022|NCT01737931|P1|Participant Flow|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
719926|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719927|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719928|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719929|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719930|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719931|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719932|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719933|NCT01738581|O2|Outcome|rTMS With Control Therapy|"Repetitive transcranial magnetic stimulation (rTMS) with non-specific therapy that includes stretching, massage, range of motion~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses."
719934|NCT01738581|O1|Outcome|rTMS With Sensorimotor Retraining|"Repetitive transcranial magnetic stimulation and sensorimotor retraining~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719935|NCT01738581|E2|Reported Event|rTMS With CTL, Then rTMS With Sensorimotor Retrain|"Repetitive transcranial magnetic stimulation (rTMS) with control (CTL) non-specific therapy that includes stretching, massage, range of motion for first phase, then rTMS with sensorimotor retraining for second phase.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719936|NCT01738581|E1|Reported Event|rTMS With Sensorimotor Retraining, Then rTMS With CTL|"Repetitive transcranial magnetic stimulation (rTMS) and sensorimotor retraining for first phase, then rTMS with control (CTL) therapy.~Repetitive Transcranial Magnetic Stimulation (Magstim): Applied to the premotor cortex at 1 Hz at 80% resting motor threshold for 1200 pulses.~Sensorimotor Retraining: For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed"
719937|NCT01738438|B1|Baseline|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
719938|NCT01738438|P1|Participant Flow|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
719939|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
719940|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
719941|NCT01738438|O1|Outcome|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
719942|NCT01738438|E1|Reported Event|Cabozantinib|Cabozantinib was given at a dose of 60 mg orally once per day for 21 day cycles. Treatment continued in the absence of disease progression or unacceptable toxicity.
719943|NCT01738321|B3|Baseline|Total|Total of all reporting groups
719944|NCT01738321|B2|Baseline|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719945|NCT01738321|B1|Baseline|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719946|NCT01738321|P2|Participant Flow|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719947|NCT01738321|P1|Participant Flow|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719948|NCT01738321|O2|Outcome|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719949|NCT01738321|O1|Outcome|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719950|NCT01738321|E2|Reported Event|Non-cardiac Patients|"Patients undergoing any surgery other than cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719951|NCT01738321|E1|Reported Event|Cardiac Patients|"Patients undergoing cardiac surgery~Cuff pressure: Measuring endotracheal tube (ETT) cuff pressure"
719952|NCT01737996|B4|Baseline|Total|Total of all reporting groups
720023|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
719953|NCT01737996|B3|Baseline|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719954|NCT01737996|B2|Baseline|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719955|NCT01737996|B1|Baseline|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719956|NCT01737996|P3|Participant Flow|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719957|NCT01737996|P2|Participant Flow|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
719958|NCT01737996|P1|Participant Flow|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose (MRD) part.
719959|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719960|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719961|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719962|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719963|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719964|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719965|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719966|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719967|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719968|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719969|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719970|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719971|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719972|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719973|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719974|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719975|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719976|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719977|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719978|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719979|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
720228|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
719980|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719981|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719982|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719983|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719984|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719985|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719986|NCT01737996|O1|Outcome|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719987|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719988|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719989|NCT01737996|O2|Outcome|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719990|NCT01737996|O1|Outcome|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719991|NCT01737996|E3|Reported Event|600 mg Deleobuvir + 120 mg Faldaprevir|"600 mg Deleobuvir administered twice daily and 120 mg Faldaprevir administered once daily for 16 days.~Oral administration with 240 mL of water under fed conditions. Combined treatment part; conducted after multiple rising dose part."
719992|NCT01737996|E2|Reported Event|600 mg Deleobuvir|600 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. High dose of multiple rising dose part.
719993|NCT01737996|E1|Reported Event|400 mg Deleobuvir|400 mg Deleobuvir administered twice daily for 9 days. Oral administration with 240 mL of water under fed conditions. Low dose of multiple rising dose part.
719994|NCT01737944|B5|Baseline|Total|Total of all reporting groups
719995|NCT01737944|B4|Baseline|25mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
719996|NCT01737944|B3|Baseline|20mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
719997|NCT01737944|B2|Baseline|15mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
719998|NCT01737944|B1|Baseline|10mg MTX Group|[Administered via randomized sequence and crossover of Treatment Arm A, Treatment Arm B and Treatment Arm C]
719999|NCT01737944|P4|Participant Flow|25mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
720000|NCT01737944|P3|Participant Flow|20mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
720001|NCT01737944|P2|Participant Flow|15mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
720002|NCT01737944|P1|Participant Flow|10mg MTX Group|[administered via randomized sequence and crossover of Treatment Arm A -SC injection with Vibex MTX device, Treatment Arm B -SC injection without device and Treatment Arm C -IM Injection]
720003|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
720004|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
720005|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
720006|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
720007|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
720008|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
720009|NCT01737944|O3|Outcome|Treatment Arm C|Intramuscular (IM) injection of MTX
720010|NCT01737944|O2|Outcome|Treatment Arm B|SC injection of MTX without the device
720011|NCT01737944|O1|Outcome|Treatment Arm A|Subcutaneous (SC) injection with the Vibex MTX device
720012|NCT01737944|E4|Reported Event|25mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
720013|NCT01737944|E3|Reported Event|20mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
720014|NCT01737944|E2|Reported Event|15mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
720015|NCT01737944|E1|Reported Event|10mg MTX|[Administered via randomized sequence and crossover of Treatment A, Treatment B and Treatment C]
720016|NCT01737931|B4|Baseline|Total|Total of all reporting groups
720017|NCT01737931|B3|Baseline|No-treatment|No treatment to the application sites after the patch removal
720018|NCT01737931|B2|Baseline|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
720019|NCT01737931|B1|Baseline|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
720021|NCT01737931|P2|Participant Flow|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
720024|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
720025|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
720026|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
720027|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
720028|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
720029|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
720030|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
720031|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
720032|NCT01737931|O3|Outcome|No-treatment|No treatment to the application sites after the patch removal
720033|NCT01737931|O2|Outcome|Topical Antihistamine|Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal
720034|NCT01737931|O1|Outcome|Topical Steroid|Topical medication of steroid (Dexamethasone) to the application sites after the patch removal
720035|NCT01737931|E1|Reported Event|Over-all|"In this study, all the subjects were received SPM962 with the same dose and regimen during the acceleration and dose-escalation periods and then they were randomized into one of the three groups after removal of SPM962 to evaluate recovery of skin reaction caused by SPM962 using either steroids, antihistamine or no treatment.~Since AEs mainly occurred in the acceleration and dose-escalation periods when SPM962 were used, AEs are shown in one group."
720036|NCT01737879|B1|Baseline|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
720037|NCT01737879|P1|Participant Flow|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
720038|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
720039|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
720040|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
720041|NCT01737879|O1|Outcome|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
720042|NCT01737879|E1|Reported Event|Peginesatide|Participants were treated with peginesatide administered intravenously (IV) every 4 weeks for 24 weeks. Participants were then to be converted back to epoetin alfa administered by IV 3 times a week for 32 weeks.
720043|NCT01737840|B3|Baseline|Total|Total of all reporting groups
720044|NCT01737840|B2|Baseline|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
720045|NCT01737840|B1|Baseline|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
720046|NCT01737840|P2|Participant Flow|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
720047|NCT01737840|P1|Participant Flow|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
720048|NCT01737840|O2|Outcome|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
720049|NCT01737840|O1|Outcome|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
720050|NCT01737840|O2|Outcome|Ranitidine|Intravenous ranitidine 50 mg
720051|NCT01737840|O1|Outcome|Pantoprazole|Intravenous pantoprazole 40 mg
720052|NCT01737840|E2|Reported Event|Ranitidine|"Intravenous ranitidine 50 mg~Ranitidine: 33 patients"
720053|NCT01737840|E1|Reported Event|Pantoprazole|"Intravenous pantoprazole 40 mg flacon~Pantoprazole: 33 patients"
720054|NCT01737710|B6|Baseline|Total|Total of all reporting groups
720055|NCT01737710|B5|Baseline|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720056|NCT01737710|B4|Baseline|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
720057|NCT01737710|B3|Baseline|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720058|NCT01737710|B2|Baseline|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720059|NCT01737710|B1|Baseline|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720060|NCT01737710|P5|Participant Flow|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720229|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720061|NCT01737710|P4|Participant Flow|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
720128|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720062|NCT01737710|P3|Participant Flow|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720063|NCT01737710|P2|Participant Flow|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720064|NCT01737710|P1|Participant Flow|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720065|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720066|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720067|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720068|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720069|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720070|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720071|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720072|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720073|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720074|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720075|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720076|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720077|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720078|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720079|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720080|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720081|NCT01737710|O2|Outcome|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720082|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720083|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720084|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720085|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720086|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720087|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720088|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720089|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720090|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720091|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720092|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720093|NCT01737710|O2|Outcome|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720094|NCT01737710|O1|Outcome|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720095|NCT01737710|E5|Reported Event|Mild AD, Intradermal|Mild atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720096|NCT01737710|E4|Reported Event|Non-AD, Intramuscular|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials
720097|NCT01737710|E3|Reported Event|Moderate to Severe AD, Intramuscular|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone (Intramuscular) influenza vaccine from 0.5 mL single dose vials.
720098|NCT01737710|E2|Reported Event|Moderate to Severe AD, Intradermal|Moderate to severe atopic dermatitis (AD) participants who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720099|NCT01737710|E1|Reported Event|Non-AD, Intradermal|Non-atopic dermatitis (AD) controls who received a single dose of the seasonal 2012-2013 Fluzone Intradermal influenza vaccine via a single-dose pre-filled microinjection system (0.1mL).
720100|NCT01737684|B3|Baseline|Total|Total of all reporting groups
720101|NCT01737684|B2|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720102|NCT01737684|B1|Baseline|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720103|NCT01737684|P3|Participant Flow|Participants With Mild Hepatic Insufficiencey|Participants with mild hepatic insufficiency were to receive a single oral dose of vibegron 100 mg.
720104|NCT01737684|P2|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720105|NCT01737684|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720106|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720107|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720108|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720109|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720110|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720111|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720112|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720113|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720114|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720115|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720116|NCT01737684|O2|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720117|NCT01737684|O1|Outcome|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720118|NCT01737684|E2|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
720119|NCT01737684|E1|Reported Event|Participants With Moderate Hepatic Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
720120|NCT01737593|B4|Baseline|Total|Total of all reporting groups
720121|NCT01737593|B3|Baseline|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720122|NCT01737593|B2|Baseline|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720123|NCT01737593|B1|Baseline|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720124|NCT01737593|P3|Participant Flow|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720125|NCT01737593|P2|Participant Flow|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720126|NCT01737593|P1|Participant Flow|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720230|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720127|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720129|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720130|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720131|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720132|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720133|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720134|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720135|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720136|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720137|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720138|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720139|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720140|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720141|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720142|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720143|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720144|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720145|NCT01737593|O3|Outcome|Acetaminophen PO - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720146|NCT01737593|O2|Outcome|Acetaminophen PO - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720147|NCT01737593|O1|Outcome|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720148|NCT01737593|O3|Outcome|Acetaminophen by Mouth (PO) - High Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720149|NCT01737593|O2|Outcome|Acetaminophen by Mouth (PO) - Low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720150|NCT01737593|O1|Outcome|Acetaminophen by Rectum (PR)|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720151|NCT01737593|E3|Reported Event|Acetaminophen PO-high Dose|"Acetaminophen PO (20mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720152|NCT01737593|E2|Reported Event|Acetaminophen PO-low Dose|"Acetaminophen PO (10mg/kg) 60-120min before start of BMT placement (acetaminophen is in syrup form and given by mouth)~Acetaminophen"
720153|NCT01737593|E1|Reported Event|Acetaminophen PR|"Acetaminophen PR (20-40mg/kg) after induction of Anesthesia (acetaminophen is in suppository form and given rectally)~Acetaminophen"
720154|NCT01737021|B3|Baseline|Total|Total of all reporting groups
720155|NCT01737021|B2|Baseline|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
720156|NCT01737021|B1|Baseline|Psycho-educational Intervention|Received psycho-educational intervention.
720157|NCT01737021|P2|Participant Flow|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
720158|NCT01737021|P1|Participant Flow|Psycho-educational Intervention|"Psycho-education~Psycho-education: The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate."
720159|NCT01737021|O2|Outcome|Study Design|There were also six feasibility criteria related to the study design, covering recruitment/ participation rate, acceptability of procedures, loss to follow-up rate, and the time-scale of data collection.
720160|NCT01737021|O1|Outcome|Intervention|There were six feasibility criteria related to the intervention, covering aspects of the timing of the intervention, compliance, and evaluation.
720161|NCT01737021|E2|Reported Event|Treatment as Usual|There is no existing standard follow up for parents of children discharged from PICU.
720162|NCT01737021|E1|Reported Event|Psycho-educational Intervention|Received psycho-educational intervention.
720185|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
724035|NCT01719003|P7|Participant Flow|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
720231|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720232|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720163|NCT01736930|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720164|NCT01736930|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720165|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720166|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720167|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720168|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720169|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720170|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720171|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720172|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720173|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720174|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720175|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720176|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720177|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720178|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720179|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720180|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720181|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720182|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720183|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720184|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720186|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720187|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720188|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720189|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720190|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720191|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720192|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720193|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720194|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720195|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720196|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720197|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720198|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720199|NCT01736930|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720200|NCT01736930|O1|Outcome|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720201|NCT01736930|E2|Reported Event|Standard of Care|The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
720202|NCT01736930|E1|Reported Event|Predictive Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
720203|NCT01736917|B1|Baseline|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
720204|NCT01736917|P1|Participant Flow|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m^2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
720227|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720205|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
720206|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
720207|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
720208|NCT01736917|O1|Outcome|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8 PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
720209|NCT01736917|E1|Reported Event|Fosaprepitant + 5HT3 Receptor Antagonists + Dexamethasone|"Patients must have no nausea and/or vomiting for 24 hours and must not have used other anti-emetics for 72 hours prior to starting protocol treatment. Treatment must not start until this criteria is satisfied.~- Any germ cell chemotherapy regimen utilizing Cisplatin (20mg/m2 x 5 days).~Acute emesis prophylaxis:~Any 5HT3 receptor antagonist may be used D1 - 5 or D1, 3 and 5 if palonosetron is used per institutional standards.~Dexamethasone 20mg PO (orally) daily, D1 and 2~Fosaprepitant 150mg IV on day 3~Delayed emesis prophylaxis:~Fosaprepitant 150mg IV on D5~Dexamethasone 4mg PO BID (twice a day) on D6, 7 and 8~PRN antiemetics allowed at the discretion of the treating investigator~No additional doses of 5HT3 receptor antagonist, dexamethasone, or fosaprepitant will be given during the acute or delayed treatment periods~Fosaprepitant: Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophyl"
720210|NCT01736696|B8|Baseline|Total|Total of all reporting groups
720211|NCT01736696|B7|Baseline|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720212|NCT01736696|B6|Baseline|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720213|NCT01736696|B5|Baseline|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720214|NCT01736696|B4|Baseline|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720215|NCT01736696|B3|Baseline|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720216|NCT01736696|B2|Baseline|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720217|NCT01736696|B1|Baseline|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720218|NCT01736696|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720219|NCT01736696|P6|Participant Flow|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720220|NCT01736696|P5|Participant Flow|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720221|NCT01736696|P4|Participant Flow|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720222|NCT01736696|P3|Participant Flow|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720223|NCT01736696|P2|Participant Flow|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720224|NCT01736696|P1|Participant Flow|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720225|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720226|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720233|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720234|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720235|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720236|NCT01736696|O4|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720237|NCT01736696|O3|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720238|NCT01736696|O2|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720239|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720240|NCT01736696|O3|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720241|NCT01736696|O2|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720242|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720243|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720244|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720245|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720246|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720247|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720248|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720249|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720250|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720251|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720252|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720253|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720254|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720255|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720256|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720257|NCT01736696|O1|Outcome|All CP-690,550 Treated Participants|Included all participants who received either CP-690,550 OPC or CP-690,550 tablets for 14 days.
720258|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720259|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720260|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720261|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720262|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720263|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720264|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720265|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720266|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720267|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720268|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720269|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720270|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720271|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720272|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720273|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720274|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720275|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720276|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720277|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720278|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720279|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720280|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720281|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720282|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720283|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720284|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720285|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720286|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720287|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720288|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720289|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720290|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720291|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720292|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720293|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720294|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720295|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720296|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720297|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720298|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720299|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720300|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720301|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720302|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720303|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720304|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720305|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720306|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720307|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720308|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720309|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720310|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720311|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720312|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720313|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720314|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720315|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720316|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720317|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720318|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720319|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720320|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720321|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720322|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720323|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720324|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720325|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720326|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720327|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720328|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
724089|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
720329|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720330|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720331|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720332|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720333|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720334|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720335|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720336|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720337|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720338|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720339|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720340|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720341|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720342|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720343|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720344|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720345|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720346|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720347|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720348|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720349|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720350|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720351|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720352|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720353|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720354|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720355|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720356|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720357|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720358|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720359|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720360|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720361|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720362|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720363|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720364|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720365|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720366|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720367|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720368|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720369|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720370|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720371|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720372|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720373|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720374|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720375|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720376|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720377|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
724156|NCT01718509|P1|Participant Flow|PLACEBO|Administered once-daily, orally, for up to 12 weeks
720378|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720379|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720380|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720381|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720382|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720383|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720384|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720385|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720386|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720387|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720388|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720389|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720390|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720391|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720392|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720393|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720394|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720395|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720396|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720397|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720398|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720399|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720400|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720401|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720402|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720403|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720404|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720405|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720406|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720407|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720408|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720409|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720410|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720411|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720412|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720413|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720414|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720415|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720416|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720417|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720418|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720419|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720420|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720421|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720422|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720423|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720424|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720425|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720426|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720427|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720622|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720428|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720429|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720430|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720431|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720432|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720433|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720434|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720435|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720436|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720437|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720438|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720439|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720440|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720441|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720442|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720443|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720444|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720445|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720446|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720447|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720448|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720449|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720450|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720451|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720452|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720453|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720454|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720455|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720456|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720457|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720458|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720459|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720460|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720461|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720462|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720463|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720464|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720465|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720466|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720467|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720468|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720469|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720470|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720471|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720472|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720473|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720474|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720475|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720476|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720477|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720478|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720479|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720480|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720481|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720482|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720483|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720484|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720485|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720486|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720487|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720488|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720489|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720490|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720491|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720492|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720493|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720494|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720495|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720496|NCT01736696|O2|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720497|NCT01736696|O1|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720498|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720499|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720500|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720501|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720502|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720503|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720504|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720505|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720506|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720507|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720508|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720509|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720510|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720511|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720512|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720513|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720514|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720515|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720516|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720517|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720518|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720519|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720520|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720521|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720522|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720523|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720524|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720569|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720525|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720526|NCT01736696|O7|Outcome|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720527|NCT01736696|O6|Outcome|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720528|NCT01736696|O5|Outcome|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720529|NCT01736696|O4|Outcome|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720530|NCT01736696|O3|Outcome|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720531|NCT01736696|O2|Outcome|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720532|NCT01736696|O1|Outcome|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720533|NCT01736696|E7|Reported Event|Placebo|Placebo matched to CP-690,550 for 13 days and single oral dose on Day 14.
720534|NCT01736696|E6|Reported Event|CP-690,550 50 mg (Cohort 6)|CP-690,550 50 mg tablets orally twice daily for 13 days and single oral dose on Day 14.
720535|NCT01736696|E5|Reported Event|CP-690,550 60 mg (Cohort 5)|CP-690,550 60 mg tablets orally once daily up to Day 14.
720536|NCT01736696|E4|Reported Event|CP-690,550 30 mg (Cohort 4)|CP-690,550 30 mg OPC twice daily for 13 days and single oral dose on Day 14.
720537|NCT01736696|E3|Reported Event|CP-690,550 20 mg (Cohort 3)|CP-690,550 20 mg OPC twice daily for 13 days and single oral dose on Day 14.
720538|NCT01736696|E2|Reported Event|CP-690,550 10 mg (Cohort 2)|CP-690,550 10 mg OPC twice daily for 13 days and single oral dose on Day 14.
720539|NCT01736696|E1|Reported Event|CP-690,550 5 mg (Cohort 1)|CP-690,550 5 milligram (mg) oral powder for constitution (OPC) twice daily for 13 days and single oral dose on Day 14.
720540|NCT01736657|B1|Baseline|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
720541|NCT01736657|P1|Participant Flow|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
720542|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
720543|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
720544|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
720545|NCT01736657|O1|Outcome|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
720546|NCT01736657|E1|Reported Event|Red Blood Cell Exchange for Patients With Sickle Cell Disease|Red blood cell exchange or depletion/exchange for patients with sickle cell disease : The purpose of this study is to evaluate the performance of the Red Blood Cell Exchange protocol on the Spectra Optia Apheresis System.
720547|NCT01736579|B3|Baseline|Total|Total of all reporting groups
720548|NCT01736579|B2|Baseline|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720549|NCT01736579|B1|Baseline|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720550|NCT01736579|P2|Participant Flow|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720551|NCT01736579|P1|Participant Flow|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720552|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720553|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720554|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720555|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720556|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720557|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720558|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720559|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720560|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720561|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720562|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720563|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720564|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720565|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720566|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720567|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720568|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720685|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
720570|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720571|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720572|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720573|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720574|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720575|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720576|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720577|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720578|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720579|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720580|NCT01736579|O2|Outcome|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks
720581|NCT01736579|O1|Outcome|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks
720582|NCT01736579|E2|Reported Event|IGIV, 10% at 0.4 g/kg Body Weight|IGIV, 10% at 0.4 g/kg body weight every 2 weeks.
720583|NCT01736579|E1|Reported Event|IGIV, 10% at 0.2 g/kg Body Weight|IGIV, 10% at 0.2 g/kg body weight every 2 weeks.
720584|NCT01736540|B1|Baseline|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720585|NCT01736540|P1|Participant Flow|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720586|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720587|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720588|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720589|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720590|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720591|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720592|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720593|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720594|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720595|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720596|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720597|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720598|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720599|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720600|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720601|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720602|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720603|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720604|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720605|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720606|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720607|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720608|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720609|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720610|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720611|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720612|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720613|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720614|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720615|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720616|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720617|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720618|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720619|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720620|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720621|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720623|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720624|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720625|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720626|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720627|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720628|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720629|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720630|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720631|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720632|NCT01736540|O5|Outcome|Other Anaemias|Subset of overall participants with other types of anaemia
720633|NCT01736540|O4|Outcome|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720634|NCT01736540|O3|Outcome|Melodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720635|NCT01736540|O2|Outcome|Thalassemia Major|Subset of overall participants with thalassemia major
720636|NCT01736540|O1|Outcome|Magnetic Resonance Imaging (MRI)|All participants were subjected to a non-invasive hepatic and cardiac MRI within 60 days of enrollment to measure iron overload.
720637|NCT01736540|E4|Reported Event|Non-transfusion-dependent Anaemia (NTDT)|Subset of overall participants with NTDT
720638|NCT01736540|E3|Reported Event|Other Anaemia|Subset of overall participants with other types of anaemias
720639|NCT01736540|E2|Reported Event|Myelodysplastic Syndrome (MDS)|Subset of overall participants with MDS
720640|NCT01736540|E1|Reported Event|Thalassaemia Major|Subset of overall participants with thalassemia major
720641|NCT01736527|B1|Baseline|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
720642|NCT01736527|P1|Participant Flow|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
720643|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
720644|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
720645|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
720646|NCT01736527|O1|Outcome|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
720647|NCT01736527|E1|Reported Event|LE Gel|"A single dose LE Gel 0.5% administered into the study eye, tear samples collected at 6, 9, 12, and 24 hours after instillation by Schirmer strip to measures levels of LE in tears.~LE Gel : Single drop of LE Gel 0.5% administered to the study eye on visit 2"
720648|NCT01736475|B3|Baseline|Total|Total of all reporting groups
720649|NCT01736475|B2|Baseline|On-demand|
720650|NCT01736475|B1|Baseline|Prophylaxis|
720651|NCT01736475|P2|Participant Flow|On-demand|10 to 60 ± 5 IU/kg
720652|NCT01736475|P1|Participant Flow|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
720653|NCT01736475|O2|Outcome|On-demand|
720654|NCT01736475|O1|Outcome|Prophylaxis|
720655|NCT01736475|O2|Outcome|On-demand|
720656|NCT01736475|O1|Outcome|Prophylaxis|
720657|NCT01736475|O2|Outcome|On-demand|
720658|NCT01736475|O1|Outcome|Prophylaxis|
720659|NCT01736475|O2|Outcome|On-demand|
720660|NCT01736475|O1|Outcome|Prophylaxis|
720661|NCT01736475|O2|Outcome|On-demand|
720662|NCT01736475|O1|Outcome|Prophylaxis|
720663|NCT01736475|O2|Outcome|On-demand|
720664|NCT01736475|O1|Outcome|Prophylaxis|
720665|NCT01736475|O2|Outcome|On-demand|
720666|NCT01736475|O1|Outcome|Prophylaxis|
720667|NCT01736475|O2|Outcome|On-demand|
720668|NCT01736475|O1|Outcome|Prophylaxis|
720669|NCT01736475|O2|Outcome|On-demand|
720670|NCT01736475|O1|Outcome|Prophylaxis|
720671|NCT01736475|O2|Outcome|On-demand|
720672|NCT01736475|O1|Outcome|Prophylaxis|
720673|NCT01736475|O2|Outcome|On-deamand|
720674|NCT01736475|O1|Outcome|Prophylaxis|
720675|NCT01736475|O2|Outcome|On-demand|
720676|NCT01736475|O1|Outcome|Prophylaxis|
720677|NCT01736475|O2|Outcome|On-demand|
720678|NCT01736475|O1|Outcome|Prophylaxis|
720679|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
720680|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
720681|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
720682|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
720683|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
720684|NCT01736475|O1|Outcome|Pharmacokinetic Analysis Participants|
720688|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion SF-36 Scores
720689|NCT01736475|O2|Outcome|On-demand|Participants with both baseline and study completion HAEMO-SYM scores
720690|NCT01736475|O1|Outcome|Prophylaxis|Participants with both baseline and study completion HAEMO-SYM scores
720691|NCT01736475|O2|Outcome|On-demand|10 to 60 ± 5 IU/kg
720692|NCT01736475|O1|Outcome|Prophylaxis|Twice weekly at a dose of 45 ± 5 IU/kg
720693|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
720694|NCT01736475|O1|Outcome|All Study Participants|All Study Participants who received at least one infusion of BAX855.
720695|NCT01736475|O1|Outcome|All Study Participants|
720696|NCT01736475|O2|Outcome|On-demand|
720697|NCT01736475|O1|Outcome|Prophylaxis|
720698|NCT01736475|O2|Outcome|On-demand|
720699|NCT01736475|O1|Outcome|Prophylaxis|Break-through bleeds during prophylaxis
720700|NCT01736475|O1|Outcome|Participants With a Bleeding Episode|All bleeding episodes treated with BAX 855 in participants on on-demand and prophylaxis treatment regimens.
720701|NCT01736475|O2|Outcome|On-demand|
720702|NCT01736475|O1|Outcome|Prophylaxis|
720703|NCT01736475|E1|Reported Event|All Study Participants|All study participants were analyzed in a single arm/group.
720704|NCT01736215|B1|Baseline|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720705|NCT01736215|P1|Participant Flow|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720706|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720707|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720708|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720709|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720710|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720711|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720712|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720713|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720714|NCT01736215|O1|Outcome|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720715|NCT01736215|E1|Reported Event|Participants With Cancer Related Anemia|Participants with cancer related anemia receiving erythropoietin (dosage and regimen were complied with Thai food and drug administration approval package insert) were observed for response to erythropoietin treatment.
720716|NCT01736176|B1|Baseline|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720717|NCT01736176|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|Participants had a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually. The starting total daily dose of LCIG was based solely on the daily dose of the oral levodopa taken immediately prior to Day 1 and was adjusted to obtain the optimal clinical response for the individual participant. Participants received treatment for up to 60 weeks; participants who completed their Week 60 visit before LCIG was commercially available had the option to extend their LCIG therapy, if in the opinion of the investigator, the participant would benefit from continued LCIG treatment.
720718|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720719|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720854|NCT01735201|B7|Baseline|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
720858|NCT01735201|B3|Baseline|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
720859|NCT01735201|B2|Baseline|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
720720|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720721|NCT01736176|O2|Outcome|Week 60|
720722|NCT01736176|O1|Outcome|Week 12|
720723|NCT01736176|O2|Outcome|Week 60|
720724|NCT01736176|O1|Outcome|Week 12|
720725|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720726|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720727|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720728|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720729|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720730|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720731|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720732|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720733|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720734|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720735|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720736|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720737|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720738|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720739|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720855|NCT01735201|B6|Baseline|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
720856|NCT01735201|B5|Baseline|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
720740|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720741|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720742|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720743|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720744|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720745|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720746|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720747|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720748|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720749|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720750|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720751|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720752|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720753|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720754|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720755|NCT01736176|O2|Outcome|Overall|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure and no more than 30 days after the end of the LCIG Treatment Period.
720756|NCT01736176|O1|Outcome|Week 1-4|Any adverse events that began or worsened in severity on or after the date of the first PEG-J placement procedure through week 4.
720757|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720857|NCT01735201|B4|Baseline|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
720758|NCT01736176|O1|Outcome|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720759|NCT01736176|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel|Participants had a PEG-J tube placement procedure performed on Day 1 and, at the discretion of the investigator, began initiation and titration of LCIG infusion. Dosing was determined individually and was adjusted to obtain the optimal clinical response for each participant. Participants received treatment for up to 60 weeks or until LCIG was commercially available.
720760|NCT01735916|B4|Baseline|Total|Total of all reporting groups
720761|NCT01735916|B3|Baseline|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720762|NCT01735916|B2|Baseline|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720763|NCT01735916|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
720764|NCT01735916|P3|Participant Flow|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720765|NCT01735916|P2|Participant Flow|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720766|NCT01735916|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
720767|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720768|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720769|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720770|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720771|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720772|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720773|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720774|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720775|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720776|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720777|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720778|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720779|NCT01735916|O2|Outcome|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal right ventricular-only pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720780|NCT01735916|O1|Outcome|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720781|NCT01735916|E3|Reported Event|CRT-P OFF|Subjects who were implanted with a CRT-P device and device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
720782|NCT01735916|E2|Reported Event|CRT-P ON|Subjects who were implanted with a CRT-P device and device programmed to provide simultaneous or sequential biventricular pacing to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care.
720783|NCT01735916|E1|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P device and were not randomized.
720784|NCT01735877|B3|Baseline|Total|Total of all reporting groups
720785|NCT01735877|B2|Baseline|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720786|NCT01735877|B1|Baseline|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720787|NCT01735877|P2|Participant Flow|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720788|NCT01735877|P1|Participant Flow|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720789|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720790|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720791|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720792|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720793|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720794|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720795|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720796|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720797|NCT01735877|O2|Outcome|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720825|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720798|NCT01735877|O1|Outcome|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720799|NCT01735877|E2|Reported Event|Control Group|"Group 2 will be given sham mirror therapy~Control group: The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation."
720800|NCT01735877|E1|Reported Event|Mirror Therapy|Mirror therapy: During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
720801|NCT01735630|B3|Baseline|Total|Total of all reporting groups
720802|NCT01735630|B2|Baseline|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720803|NCT01735630|B1|Baseline|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720804|NCT01735630|P2|Participant Flow|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720805|NCT01735630|P1|Participant Flow|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720806|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720807|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720808|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720809|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720810|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720811|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720812|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720813|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720814|NCT01735630|O2|Outcome|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720815|NCT01735630|O1|Outcome|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720816|NCT01735630|E2|Reported Event|Placebo|"Matched placebo BID for 12 weeks~Placebo"
720817|NCT01735630|E1|Reported Event|ELND005|"ELND005 film coated tablets, BID for 12 weeks~ELND005"
720818|NCT01735617|B1|Baseline|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720819|NCT01735617|P1|Participant Flow|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720820|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720821|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720822|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720823|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720824|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720853|NCT01735201|B8|Baseline|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
720826|NCT01735617|O1|Outcome|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720827|NCT01735617|O1|Outcome|Chronocort|Chronocort Modified Release Capsules 10mg twice-daily
720828|NCT01735617|O1|Outcome|Chroncort|Chronocort Modified Release Capsules 10mg twice-daily
720829|NCT01735617|O1|Outcome|Chronocort|Chronocort Modified Release Capsules 10 mg twice-daily.
720830|NCT01735617|E1|Reported Event|Hydrocortisone Modified Release Capsules|"Chronocort Modified Release Capsules, 5mg, 10mg and 20mg Dosing frequency twice-daily (mane and nocte) Dose setting by titration to achieve optimal biochemical and therapeutic response~Hydrocortisone Modified Release Capsules: Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment"
720831|NCT01735396|B1|Baseline|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720832|NCT01735396|P1|Participant Flow|Abiraterone Acetate|"Abiraterone acetate 1000mg orally daily until the time of disease progression, in the absence of prohibitive toxicities.~Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily"
720833|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720834|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720835|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720836|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720837|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720838|NCT01735396|O1|Outcome|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720839|NCT01735396|E1|Reported Event|Abiraterone Acetate|Abiraterone Acetate: Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
720840|NCT01735214|B1|Baseline|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720841|NCT01735214|P1|Participant Flow|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720842|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720843|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720844|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720845|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720846|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720847|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720848|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720849|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720850|NCT01735214|O1|Outcome|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720851|NCT01735214|E1|Reported Event|Patients With POAG or OHT|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
720852|NCT01735201|B9|Baseline|Total|Total of all reporting groups
720860|NCT01735201|B1|Baseline|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
720861|NCT01735201|P8|Participant Flow|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
720862|NCT01735201|P7|Participant Flow|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
720863|NCT01735201|P6|Participant Flow|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
720864|NCT01735201|P5|Participant Flow|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
720865|NCT01735201|P4|Participant Flow|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
720866|NCT01735201|P3|Participant Flow|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
720867|NCT01735201|P2|Participant Flow|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
720868|NCT01735201|P1|Participant Flow|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
720869|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
720870|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
720871|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
720872|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
720873|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
720874|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
720875|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
720876|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
720877|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
720878|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
720879|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
720880|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
720881|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
720882|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
720883|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
720884|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
720885|NCT01735201|O8|Outcome|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
720886|NCT01735201|O7|Outcome|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
720887|NCT01735201|O6|Outcome|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
720888|NCT01735201|O5|Outcome|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
720889|NCT01735201|O4|Outcome|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
720890|NCT01735201|O3|Outcome|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
720891|NCT01735201|O2|Outcome|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
720892|NCT01735201|O1|Outcome|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
720893|NCT01735201|E8|Reported Event|AGN-199201 Vehicle Twice Daily|AGN-199201 Vehicle applied twice daily to the face for 28 days.
720894|NCT01735201|E7|Reported Event|AGN-199201 Dose C Twice Daily|AGN-199201 Dose C applied twice daily to the face for 28 days.
720895|NCT01735201|E6|Reported Event|AGN-199201 Dose B Twice Daily|AGN-199201 Dose B applied twice daily to the face for 28 days.
720896|NCT01735201|E5|Reported Event|AGN-199201 Dose A Twice Daily|AGN-199201 Dose A applied twice daily to the face for 28 days.
720897|NCT01735201|E4|Reported Event|AGN-199201 Vehicle Once Daily|AGN-199201 Vehicle applied once daily to the face for 28 days.
720898|NCT01735201|E3|Reported Event|AGN-199201 Dose C Once Daily|AGN-199201 Dose C applied once daily to the face for 28 days.
720899|NCT01735201|E2|Reported Event|AGN-199201 Dose B Once Daily|AGN-199201 Dose B applied once daily to the face for 28 days.
720900|NCT01735201|E1|Reported Event|AGN-199201 Dose A Once Daily|AGN-199201 Dose A applied once daily to the face for 28 days.
720901|NCT01735175|B3|Baseline|Total|Total of all reporting groups
720902|NCT01735175|B2|Baseline|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720903|NCT01735175|B1|Baseline|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720904|NCT01735175|P2|Participant Flow|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720905|NCT01735175|P1|Participant Flow|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720989|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
720906|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720907|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720908|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720909|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720910|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720911|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720912|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720913|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720914|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720915|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720916|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720917|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720918|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720919|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720920|NCT01735175|O2|Outcome|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720921|NCT01735175|O1|Outcome|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720922|NCT01735175|E2|Reported Event|Neulasta®|"During each chemotherapy cycle eligible patients receive Neulasta® s.c. post chemotherapy application.~Neulasta®: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720923|NCT01735175|E1|Reported Event|LA-EP2006|"During each chemotherapy cycle eligible patients receive LA-EP2006 s.c. post chemotherapy application.~LA-EP2006: Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application."
720924|NCT01734993|B1|Baseline|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720925|NCT01734993|P1|Participant Flow|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 long term extension (LTE) study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of greater than [>] 1.2 points) were administered tocilizumab (TCZ) in this long-term extension study, at a dose of 162 milligrams (mg) as subcutaneous (SC) injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720986|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
720926|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720927|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720928|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720929|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720930|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720931|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720932|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720933|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720934|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720935|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720936|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720937|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720938|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720939|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720940|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720988|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
720941|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720942|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720943|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720944|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720945|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720946|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720947|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720948|NCT01734993|O1|Outcome|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375-22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720949|NCT01734993|E1|Reported Event|Tocilizumab|Moderate to severe rheumatoid arthritis participants from France who completed the Week 97 visit of the WA22762 LTE study (NCT01194414, EudraCT Number 2010-018375 -22) and considered as responders (defined as having improvement in DAS28 of > 1.2 points) were administered TCZ in this long-term extension study, at a dose of 162 mg as SC injection once a week, for a maximum of 156 weeks or until SC TCZ was commercially available, whichever occurred first.
720950|NCT01734889|B1|Baseline|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720951|NCT01734889|P1|Participant Flow|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720952|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720953|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720954|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720955|NCT01734889|O1|Outcome|Age <5 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720956|NCT01734889|O1|Outcome|Age 5-<18 Years|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720957|NCT01734889|E1|Reported Event|Orfadin Suspension|Drug: nitisinone, oral suspension 4 mg/mL, twice daily dosing, total daily dose according to current prescribed dose at screening
720958|NCT01734785|B4|Baseline|Total|Total of all reporting groups
720959|NCT01734785|B3|Baseline|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720960|NCT01734785|B2|Baseline|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720961|NCT01734785|B1|Baseline|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720962|NCT01734785|P4|Participant Flow|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
720963|NCT01734785|P3|Participant Flow|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720964|NCT01734785|P2|Participant Flow|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720965|NCT01734785|P1|Participant Flow|Empagliflozin 25 mg|Patients received 1 fixed dose combination (FDC) Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720966|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720967|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720968|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720969|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720970|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720971|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720972|NCT01734785|O3|Outcome|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720973|NCT01734785|O2|Outcome|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720974|NCT01734785|O1|Outcome|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720975|NCT01734785|E4|Reported Event|Linagliptin 5 mg|Patients received 5mg dose of Linagliptin (lina 5), administered orally, once daily for 16 weeks during the OL treatment period, thereafter patients received 1 matching placebo tablet to FDC empa 25/lina 5, and 1 matching placebo tablet to FDC empa 10/lina 5 per day in addition to lina 5 OL, for 1 week during the open-label placebo add-on treatment period.
720976|NCT01734785|E3|Reported Event|Placebo|Patients received 1 lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to FDC empa 25/lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720977|NCT01734785|E2|Reported Event|Empagliflozin 10 mg|Patients received 1 FDC empa 10/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 25/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720978|NCT01734785|E1|Reported Event|Empagliflozin 25 mg|Patients received 1 FDC Empagliflozin (empa) 25/lina 5 mg tablet and two placebo tablet (1 matching placebo tablet to lina 5 and 1 matching placebo tablet to FDC empa 10/lina 5), administered orally, once every day for 24 weeks during the double blind treatment period.
720979|NCT01734772|B3|Baseline|Total|Total of all reporting groups
720980|NCT01734772|B2|Baseline|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
720981|NCT01734772|B1|Baseline|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
720982|NCT01734772|P2|Participant Flow|Part 2|In part 2, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, 180 mg ticagrelor were given 2 hours after the morning dose of 110 mg dabigatran etexilate and dabigatran PK profile were taken on this day 1 of the test treatment.
720983|NCT01734772|P1|Participant Flow|Part 1|In part 1, 110 mg dabigatran etexilate were dosed twice daily to steady state and a dabigatran PK profile was taken on day 3 (reference). On the day after the reference treatment, ticagrelor treatment was added starting with the concomitant administration of a 180 mg ticagrelor loading dose followed by 90 mg ticagrelor twice daily. Dabigatran PK profiles were taken on day 1 of the test treatment and day 4 of the test treatment.
720984|NCT01734772|O5|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
720985|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
720987|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
720990|NCT01734772|O4|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
720991|NCT01734772|O3|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg in the morning on day 4.
720992|NCT01734772|O2|Outcome|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
720993|NCT01734772|O1|Outcome|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
720994|NCT01734772|E5|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 2|Dabigatran Etexilate 110mg morning dose followed by 180mg Ticagrelor 2 hours later.
720995|NCT01734772|E4|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 2|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
720996|NCT01734772|E3|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 90mg Bid - Part 1|Multiple dosing of 90 mg bid on days 2 and 3 and 90mg on day 4 together with Dabigatran Etexilate 110mg bid on days 2 and 3 and 110mg once on day 4.
720997|NCT01734772|E2|Reported Event|Dabigatran Etexilate 110mg Bid + Ticagrelor 180 mg - Part 1|Single loading dose of Ticagrelor 180 mg on day 1 together with Dabigatran Etexilate 110mg bid.
720998|NCT01734772|E1|Reported Event|Dabigratan Etexilate 110mg Bid Alone - Part 1|Dabigatran Etexilate 110mg twice daily (bid) for 3 days
720999|NCT01734655|B1|Baseline|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
721000|NCT01734655|P1|Participant Flow|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices in either a focus group format (the first 11 participants) or cognitive interview format (the last 29 participants).
721001|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
721002|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
721003|NCT01734655|O1|Outcome|Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
721004|NCT01734655|O1|Outcome|All Participants|all participants
721005|NCT01734655|O1|Outcome|All Participants|
721006|NCT01734655|O1|Outcome|All Participants|Participants will be asked to complete the MEQ, the Eating Inventory Questionnaire, The Mindful Attention Awareness Scale (MAAS), and the Neighborhood Environment Walkability Scale (NEWS). Participants will then be asked to sequentially respond to each of the 28 items and the response choices from the MEQ and briefly discuss their reaction to the items and response choices. Finally, participants will either participate in a focus group or an individual cognitive interview, giving them the opportunity to elaborate on their responses to the MEQ. The first 11 participants completed focus groups and the remaining 29 participants completed individual cognitive interviews.
721007|NCT01734655|E1|Reported Event|All Participants|Pregnant women who were overweight or obese and 18-40 yrs of age.
721008|NCT01734395|B1|Baseline|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
721009|NCT01734395|P1|Participant Flow|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
721010|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
721011|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
721012|NCT01734395|O1|Outcome|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
721013|NCT01734395|E1|Reported Event|Galantamine|Galantamine 8 mg/day for first 4 weeks and the dose will be increased up to 24 mg (if tolerable) for next 12 weeks.
721014|NCT01734317|B1|Baseline|Mepilex Transfer Ag|
721161|NCT01733732|O3|Outcome|Systane Balance, Day 30|One drop in each eye 4 times a day for 30 days
721056|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721015|NCT01734317|P1|Participant Flow|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
721016|NCT01734317|O1|Outcome|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
721017|NCT01734317|E1|Reported Event|Dressing|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: A soft silicone wound contact layer."
721018|NCT01734239|B3|Baseline|Total|Total of all reporting groups
721019|NCT01734239|B2|Baseline|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721020|NCT01734239|B1|Baseline|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721021|NCT01734239|P2|Participant Flow|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721022|NCT01734239|P1|Participant Flow|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721023|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721024|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721025|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721026|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721027|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721028|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721029|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721030|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721031|NCT01734239|O2|Outcome|Pneumovax™ 23: Participants >=50 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721032|NCT01734239|O1|Outcome|Pneumovax™ 23: Participants Between 2 and 49 Years|Participants received a single 0.5 mL intramuscular injection on Day 1
721033|NCT01734239|E1|Reported Event|Pneumovax™ 23|Participants received a single 0.5 mL intramuscular injection on Day 1
721034|NCT01734161|B3|Baseline|Total|Total of all reporting groups
721035|NCT01734161|B2|Baseline|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
721036|NCT01734161|B1|Baseline|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
721037|NCT01734161|P2|Participant Flow|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
721038|NCT01734161|P1|Participant Flow|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
721039|NCT01734161|O2|Outcome|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
721040|NCT01734161|O1|Outcome|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
721041|NCT01734161|E2|Reported Event|Placebo|"One dose of 50 ml of 0.9% normal saline that will be given as an infusion over 10 minutes.~Placebo: Subjects randomized to placebo receive 50cc normal saline"
721042|NCT01734161|E1|Reported Event|Dexamethasone|"One dose of 8 mg of intravenous dexamethasone diluted in 50 ml of normal saline given as an infusion over 10 minutes.~Dexamethasone: 8mg IV dexamethesone given"
721043|NCT01733953|B3|Baseline|Total|Total of all reporting groups
721044|NCT01733953|B2|Baseline|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721045|NCT01733953|B1|Baseline|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721046|NCT01733953|P2|Participant Flow|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721047|NCT01733953|P1|Participant Flow|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721048|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721049|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721050|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721051|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721052|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721053|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721054|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721055|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721057|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721058|NCT01733953|O2|Outcome|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721059|NCT01733953|O1|Outcome|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721060|NCT01733953|E2|Reported Event|Sugar Pill (Placebo)|"6-Months Placebo (sugar pill); oral, once daily~Sugar Pill (Placebo): 6-Months of placebo (sugar) pill; oral, once daily"
721061|NCT01733953|E1|Reported Event|Atorvastatin|"6-Months Atorvastatin Therapy; 40mg oral, once daily~Atorvastatin: 6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily."
721062|NCT01733758|B5|Baseline|Total|Total of all reporting groups
721063|NCT01733758|B4|Baseline|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721064|NCT01733758|B3|Baseline|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721065|NCT01733758|B2|Baseline|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721066|NCT01733758|B1|Baseline|Placebo|Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721067|NCT01733758|P4|Participant Flow|Open Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721068|NCT01733758|P3|Participant Flow|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721069|NCT01733758|P2|Participant Flow|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721070|NCT01733758|P1|Participant Flow|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly to Week 52.
721071|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721072|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721073|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721074|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721075|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721076|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721077|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721078|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721079|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721080|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721081|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721082|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721083|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721084|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721085|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721086|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721162|NCT01733732|O2|Outcome|Systane Balance, Day 14|One drop in each eye 4 times a day for 30 days
721198|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
721087|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721088|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721089|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721090|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721091|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721092|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721093|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721094|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721095|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721096|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721097|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721098|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721099|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721100|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721101|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721102|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721103|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721104|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721105|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721106|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721107|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721108|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721109|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721110|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721111|NCT01733758|O4|Outcome|Open-Label Liraglutide 0.9 mg Daily|Participants received open-label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721112|NCT01733758|O3|Outcome|Albiglutide 50 mg Weekly|Participants received double-blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721113|NCT01733758|O2|Outcome|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721114|NCT01733758|O1|Outcome|Placebo|Participants received double-blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24. After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721115|NCT01733758|E5|Reported Event|Open Label Liraglutide 0.9 mg Daily|Participants received open label liraglutide as a subcutaneous injection daily at a dose of 0.3 mg with weekly forced uptitrations to a dose of 0.6 mg then a dose of 0.9 mg (maximum dose in Japan). The dose of 0.9 mg daily was given to Week 52.
721163|NCT01733732|O1|Outcome|Systane Balance, Day 0|One drop in each eye 4 times a day for 30 days
721116|NCT01733758|E4|Reported Event|Albiglutide 50 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly until Week 4. Starting at Week 4, participants received albiglutide 50 mg as a subcutaneous injection weekly to Week 52.
721117|NCT01733758|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received double blind albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721118|NCT01733758|E2|Reported Event|Placebo - After Switch|(After Switch to 30 mg algiblutide) After Week 24, participants received albiglutide 30 mg as a subcutaneous injection weekly to Week 52.
721119|NCT01733758|E1|Reported Event|Placebo - Before Switch|(Before Switch to 30 mg albiglutide) Participants received double blind matching albiglutide placebo as a subcutaneous injection weekly to Week 24.
721120|NCT01733745|B3|Baseline|Total|Total of all reporting groups
721121|NCT01733745|B2|Baseline|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
721122|NCT01733745|B1|Baseline|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
721123|NCT01733745|P2|Participant Flow|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
721124|NCT01733745|P1|Participant Flow|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
721125|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
721126|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
721127|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
721128|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
721129|NCT01733745|O2|Outcome|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
721130|NCT01733745|O1|Outcome|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
721131|NCT01733745|E2|Reported Event|Standard of Care|Microfiber towels (as warm compresses) warmed to the maximum comfortable temperature and placed over closed eyes for 8 minutes, 1 time a day. Duration of treatment was 3 months.
721132|NCT01733745|E1|Reported Event|SYSTANE® Family|SYSTANE® Lid Wipes administered to treated eye(s) once a day; SYSTANE® BALANCE lubricant eye drops administered to treated eye(s), 1 drop 4 times a day; SYSTANE® Vitamins, 2 softgels ingested daily. Duration of treatment was 3 months.
721133|NCT01733732|B3|Baseline|Total|Total of all reporting groups
721134|NCT01733732|B2|Baseline|Systane Gel|One drop in each eye 4 times a day for 30 days
721135|NCT01733732|B1|Baseline|Systane Balance|One drop in each eye 4 times a day for 30 days
721136|NCT01733732|P2|Participant Flow|Systane Gel|One drop in each eye 4 times a day for 30 days
721137|NCT01733732|P1|Participant Flow|Systane Balance|One drop in each eye 4 times a day for 30 days
721138|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721139|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721140|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721141|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721142|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721143|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721144|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721145|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721146|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721147|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721148|NCT01733732|O4|Outcome|Systane Gel, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
721149|NCT01733732|O3|Outcome|Systane Gel, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
721150|NCT01733732|O2|Outcome|Systane Balance, Change From Baseline at Day 30|One drop in each eye 4 times a day for 30 days
721151|NCT01733732|O1|Outcome|Systane Balance, Change From Baseline at Day 14|One drop in each eye 4 times a day for 30 days
721152|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721153|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721154|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721155|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721156|NCT01733732|O2|Outcome|Systane Gel|One drop in each eye 4 times a day for 30 days
721157|NCT01733732|O1|Outcome|Systane Balance|One drop in each eye 4 times a day for 30 days
721158|NCT01733732|O6|Outcome|Systane Gel, Day 30|One drop in each eye 4 times a day for 30 days
721159|NCT01733732|O5|Outcome|Systane Gel, Day 14|One drop in each eye 4 times a day for 30 days
721160|NCT01733732|O4|Outcome|Systane Gel, Day 0|One drop in each eye 4 times a day for 30 days
721170|NCT01733329|B3|Baseline|Total|Total of all reporting groups
721171|NCT01733329|B2|Baseline|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 10 mg Folic acid (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist . The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
721172|NCT01733329|B1|Baseline|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery assigned randomly to 400 mcg misoprostol (2 tablets) (n=60) placed in buccal space after umbilical cord clamping by anesthesiologist. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
721173|NCT01733329|P2|Participant Flow|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
721174|NCT01733329|P1|Participant Flow|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=62) or placebo (n=61) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
721175|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
721176|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
721177|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
721178|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
721179|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
721180|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
721181|NCT01733329|O2|Outcome|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
721182|NCT01733329|O1|Outcome|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
721183|NCT01733329|E2|Reported Event|Folic Acid|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either misoprostol (n=60) or 10 mg Folic acid (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Placebo"
721184|NCT01733329|E1|Reported Event|Misoprostol|"women with risk factors for uterine atony who underwent cesarean delivery were assigned randomly to either 400 mcg misoprostol (n=60) or placebo (n=60) placed in buccal space after umbilical cord clamping. The primary outcome variables were the need for additional uterotonic agents, estimated blood loss and uterine atony.~Misoprostol"
721185|NCT01733316|B1|Baseline|All Participants|"From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.~During Months 3.5, 4, 5, 6, 7 and for the remainder of study: participants received RP103 Q12H."
721186|NCT01733316|P1|Participant Flow|All Participants|"From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® every 6 hours (Q6H).~During Months 3.5, 4, 5, 6, 7 and for the remainder of study: participants received RP103 every 12 hours (Q12H)."
721187|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
721188|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
721189|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
721190|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
721191|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
721192|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
721193|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
721194|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
721195|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
721196|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
721197|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
721360|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721199|NCT01733316|O3|Outcome|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
721200|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
721201|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
721202|NCT01733316|O2|Outcome|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
721203|NCT01733316|O1|Outcome|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
721204|NCT01733316|E3|Reported Event|Long-Term Phase|From Month 7 and for the remainder of study: participants received RP103 Q12H.
721205|NCT01733316|E2|Reported Event|RP103 Phase|During Months 3.5, 4, 5, 6, 7: participants received RP103 Q12H.
721206|NCT01733316|E1|Reported Event|Cystagon® Phase|From Screening and during Months 1, 2, 3: participants received their usual dose of Cystagon® Q6H.
721207|NCT01733277|B3|Baseline|Total|Total of all reporting groups
721208|NCT01733277|B2|Baseline|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
721209|NCT01733277|B1|Baseline|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
721210|NCT01733277|P2|Participant Flow|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
721211|NCT01733277|P1|Participant Flow|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
721212|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
721213|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
721214|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
721215|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
721216|NCT01733277|O2|Outcome|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
721217|NCT01733277|O1|Outcome|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
721218|NCT01733277|E2|Reported Event|Absence of Neuropathic Pain|"Absence of neuropathic pain using the PainDETECT questionnaire (PainDETECT < 13)~MRI"
721219|NCT01733277|E1|Reported Event|Presence of Neuropathic Pain|"Presence of neuropathic pain using the PainDETECT questionnaire (PainDETECT ≥ 13)~MRI"
721220|NCT01733069|B3|Baseline|Total|Total of all reporting groups
721221|NCT01733069|B2|Baseline|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
721222|NCT01733069|B1|Baseline|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
721223|NCT01733069|P2|Participant Flow|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
721224|NCT01733069|P1|Participant Flow|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses.
721225|NCT01733069|O2|Outcome|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
721226|NCT01733069|O1|Outcome|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorizes as infected or non-infected were excluded from the performance analyses
721479|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721227|NCT01733069|E2|Reported Event|Negative Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
721228|NCT01733069|E1|Reported Event|Positive Infected Status|The Infected status algorithm used results from two specimen types and two reference types and two reference Nucleic Acid Amplification Tests (NAATs). Subjects were categorized as infected if a positive result occurred in each of the two reference NAATs. For female subjects, if positive NAAT result occurred only in the urine specimens and not in PreservCyt solution liquid pap specimens, the subject was categorized as infected; however for the evaluation of the non-urine specimen types, the specimens were considered non-infected. Subjects that could not be categorized as infected or non-infected were excluded from the performance analyses
721229|NCT01733056|B4|Baseline|Total|Total of all reporting groups
721230|NCT01733056|B3|Baseline|TNF Alpha Blocker|Patients with skin diseases taking TNF alpha blockers
721231|NCT01733056|B2|Baseline|Azathioprine|Patients with skin diseases taking azathioprine
721232|NCT01733056|B1|Baseline|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
721233|NCT01733056|P3|Participant Flow|TNF Alpha Blockers|
721234|NCT01733056|P2|Participant Flow|Azathioprine|
721235|NCT01733056|P1|Participant Flow|Healthy Volunteer|
721236|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
721237|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
721238|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
721239|NCT01733056|O3|Outcome|TNF Alpha Blockers|Patients with skin diseases taking TNF alpha blockers
721240|NCT01733056|O2|Outcome|Azathioprine|Patients with skin diseases taking azathioprine
721241|NCT01733056|O1|Outcome|Healthy Volunteer|Healthy volunteers without skin disease prior to influenza vaccination
721242|NCT01733056|E6|Reported Event|TNF Alpha Blocker Post-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn after vaccination with influenza vaccine
721243|NCT01733056|E5|Reported Event|TNF Alpha Blocker Pre-vaccination|Patients with skin disease treated with TNF blockers who had blood drawn prior to vaccination with influenza vaccine
721244|NCT01733056|E4|Reported Event|Azathioprine Post-vaccination|Patients with skin disease treated with azathioprine who had blood drawn after vaccination with influenza vaccine
721245|NCT01733056|E3|Reported Event|Azathioprine Pre-vaccination|Patients with skin disease treated with azathioprine who had blood drawn prior to vaccination with influenza vaccine
721246|NCT01733056|E2|Reported Event|Healthy Volunteer Post-vaccination|Healthy volunteers who had blood drawn after vaccination with influenza vaccine
721247|NCT01733056|E1|Reported Event|Healthy Volunteer Pre-vaccination|Healthy volunteers who had blood drawn prior to vaccination with influenza vaccine
721248|NCT01732926|B3|Baseline|Total|Total of all reporting groups
721249|NCT01732926|B2|Baseline|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721250|NCT01732926|B1|Baseline|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721251|NCT01732926|P2|Participant Flow|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721252|NCT01732926|P1|Participant Flow|Idelalisib + Bendamustine + Rituximab|"Idelalisib (Zydelig®) 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions)~+ rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)"
721253|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721254|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721255|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721256|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721257|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721258|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721259|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721260|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721261|NCT01732926|O2|Outcome|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721262|NCT01732926|O1|Outcome|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721263|NCT01732926|E2|Reported Event|Placebo + Bendamustine + Rituximab|Placebo tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721264|NCT01732926|E1|Reported Event|Idelalisib + Bendamustine + Rituximab|Idelalisib 150 mg tablet twice daily + bendamustine intravenously (starting dose of 90 mg/m^2 for up to 12 infusions) + rituximab intravenously (375 mg/m^2 on Day 1 for a total of 6 infusions)
721265|NCT01732913|B3|Baseline|Total|Total of all reporting groups
721266|NCT01732913|B2|Baseline|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721267|NCT01732913|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721268|NCT01732913|P2|Participant Flow|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721269|NCT01732913|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib (Zydelig®) 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721270|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721271|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721272|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721273|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721274|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721275|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721276|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721277|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721278|NCT01732913|O2|Outcome|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721279|NCT01732913|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721280|NCT01732913|E2|Reported Event|Placebo + Rituximab|Placebo tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721281|NCT01732913|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet orally twice daily + rituximab 375 mg/m^2 intravenously starting on Day 1 for a total of 8 infusions
721282|NCT01732835|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721283|NCT01732835|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721284|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721285|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721286|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721287|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721288|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721289|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721290|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721291|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721292|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721293|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721294|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721295|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721361|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721296|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721297|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721298|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721299|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721300|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721301|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721302|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721303|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721304|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721305|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721306|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721307|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721308|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721309|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721310|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721311|NCT01732835|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721312|NCT01732835|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of HAART 300 Annuloplasty Device for aortic valve repair"
721313|NCT01732796|B4|Baseline|Total|Total of all reporting groups
721314|NCT01732796|B3|Baseline|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
721315|NCT01732796|B2|Baseline|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721316|NCT01732796|B1|Baseline|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
721317|NCT01732796|P3|Participant Flow|24 wk CR FDV+DBV+RBV|600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
721318|NCT01732796|P2|Participant Flow|24 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin (RBV) BID for 24 weeks (wk). All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
721319|NCT01732796|P1|Participant Flow|16 wk NC FDV+DBV+RBV|"600 milligram (mg) of Deleobuvir (DBV) twice daily (BID) combined with 240 mg on the first day followed by 120mg of Faldaprevir (FDV) once daily (QD) and 1000-1200mg Ribavirin BID (RBV) for 16 weeks (wk) followed by DBV placebo, FDV placebo and RBV placebo for 8 weeks. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
721320|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
721321|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721322|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721323|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
721324|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721325|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721326|NCT01732796|O3|Outcome|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
721327|NCT01732796|O2|Outcome|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721328|NCT01732796|O1|Outcome|16 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721329|NCT01732796|O2|Outcome|16 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID), orally. This is the combination of non-cirrhotic patients in the 16 week treatment group and cirrhosis patients in the 24-week treatment group.
721330|NCT01732796|O1|Outcome|24 wk FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk (orally) in cirrhotic and non-cirrhotic patients.
721331|NCT01732796|E3|Reported Event|24 wk CR FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group comprised patients with compensated cirrhosis (CR) who received open label treatment.
721332|NCT01732796|E2|Reported Event|24 wk NC FDV+DBV+RBV|600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 24wk. All were administered per os (orally). This group included non-cirrhotic patients (NC).
721333|NCT01732796|E1|Reported Event|16 wk NC FDV+DBV+RBV|"600 mg DBV (BID) + 120mg FDV (QD) + 1000-1200mg RBV (BID) for 16wk followed by DBV placebo, FDV placebo and RBV placebo for 8wk. All were administered per os (orally).~This group included non-cirrhotic patients (NC)."
721334|NCT01732770|B3|Baseline|Total|Total of all reporting groups
721335|NCT01732770|B2|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
721336|NCT01732770|B1|Baseline|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
721337|NCT01732770|P2|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
721338|NCT01732770|P1|Participant Flow|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
721339|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
721340|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
721341|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
721342|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
721343|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
721344|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
721345|NCT01732770|O2|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
721346|NCT01732770|O1|Outcome|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
721347|NCT01732770|E2|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg subcutaneous injection once every 6 months (Q6M) for 12 months and placebo to zoledronic acid by intravenous infusion on Day 1.
721348|NCT01732770|E1|Reported Event|Zoledronic Acid 5 mg Q12M|Participants received zoledronic acid 5 mg by intravenous infusion once every 12 months (Q12M) on Day 1 and placebo to denosumab by subcutaneous injection on Day 1 and at Month 6.
721349|NCT01732757|B4|Baseline|Total|Total of all reporting groups
721350|NCT01732757|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721351|NCT01732757|B2|Baseline|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721352|NCT01732757|B1|Baseline|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721353|NCT01732757|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721354|NCT01732757|P2|Participant Flow|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721355|NCT01732757|P1|Participant Flow|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721356|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721357|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721358|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721359|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721362|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721363|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721364|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721365|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721366|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721367|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721368|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721369|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721370|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721371|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721372|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721373|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721374|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721375|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721376|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721377|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721378|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721379|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721380|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721381|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721382|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721383|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721384|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721385|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721386|NCT01732757|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721387|NCT01732757|O2|Outcome|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721388|NCT01732757|O1|Outcome|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721389|NCT01732757|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of Placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
721390|NCT01732757|E2|Reported Event|Pataday™|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
721391|NCT01732757|E1|Reported Event|Lastacaft®|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
721392|NCT01732692|B3|Baseline|Total|Total of all reporting groups
721393|NCT01732692|B2|Baseline|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721394|NCT01732692|B1|Baseline|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721395|NCT01732692|P2|Participant Flow|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721396|NCT01732692|P1|Participant Flow|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721397|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721398|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721399|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721400|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721401|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721402|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721403|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721404|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721405|NCT01732692|O2|Outcome|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721406|NCT01732692|O1|Outcome|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721407|NCT01732692|E2|Reported Event|MOVIPREP (Split-dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), once the evening before colonoscopy and once the morning of colonoscopy.
721408|NCT01732692|E1|Reported Event|MOVIPREP (Morning-only Dose)|MOVIPREP 250 ml solution every 15 minutes for up to one hour (4 doses in 1 hour=1 litre of solution), twice within same morning of colonoscopy.
721409|NCT01732588|B4|Baseline|Total|Total of all reporting groups
721410|NCT01732588|B3|Baseline|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
721411|NCT01732588|B2|Baseline|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A)
721412|NCT01732588|B1|Baseline|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
721413|NCT01732588|P3|Participant Flow|Sequence 3|Subjects received a single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A); then 120 mg OZ439 IR caplet (Regimen B).
721414|NCT01732588|P2|Participant Flow|Sequence 2|Subjects received a single dose of 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C); then 120 mg OZ439 PIB oral suspension (Regimen A).
721415|NCT01732588|P1|Participant Flow|Sequence 1|Subjects received a single dose of 120 mg OZ439 PIB oral suspension (Regimen A), then 120 mg OZ439 IR caplet (Regimen B); then 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule (Regimen C)
721416|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
721417|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
721418|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
721419|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
721420|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
721421|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
721422|NCT01732588|O3|Outcome|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate delivered to the PSB via Enterion capsule
721423|NCT01732588|O2|Outcome|Regimen B - 120 mg OZ439 IR Caplet|Single dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
721424|NCT01732588|O1|Outcome|Regimen A - OZ439 120mg PIB|Single dose of 120 mg OZ439 powder in bottle (PIB) oral suspension
721425|NCT01732588|E3|Reported Event|Regimen C - 120 mg OZ439 Caplet Via Enterion Capsule|Single dose of 120 mg OZ439 caplet formulation containing nanoparticulate administered orally via the Enterion capsule
721426|NCT01732588|E2|Reported Event|Regimen B - 120 mg OZ439 IR Caplet|Single oral dose of 120 mg OZ439 Immediate release (IR) caplet formulation containing nanoparticulate
721427|NCT01732588|E1|Reported Event|Regimen A - 120mg OZ439 PIB|Single oral dose of 120 mg OZ439 as powder in bottle (PIB) formulation.
721428|NCT01732549|B3|Baseline|Total|Total of all reporting groups
721429|NCT01732549|B2|Baseline|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
721430|NCT01732549|B1|Baseline|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
721431|NCT01732549|P2|Participant Flow|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
721432|NCT01732549|P1|Participant Flow|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
721433|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721434|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
721435|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721436|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
721437|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721438|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
721439|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721440|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
721441|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721442|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
721443|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721444|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
721445|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721446|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression
721447|NCT01732549|O2|Outcome|Placebo|1 capsule daily, taken orally with water and food until disease progression
721448|NCT01732549|O1|Outcome|Tasquinimod|1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.
721449|NCT01732549|E2|Reported Event|Placebo|"1 capsule daily, taken orally with water and food until disease progression~Placebo: Patients received Placebo capsules (identical to tasquinimod capsules) to be taken orally once a day with water and food"
721450|NCT01732549|E1|Reported Event|Tasquinimod|"1 capsule daily, taken orally with water and food (0.25 mg initially then dose escalated to 0.5 mg and then to 1 mg per day) until disease progression.~Tasquinimod: Patients received initially an oral dose of 0.25 mg/day of tasquinimod, starting on Day 1, for at least 2 weeks. Once tolerability of the 0.25 mg/day dose was established, patients received a dose increase to 0.5 mg/day for at least 2 weeks, and then increased to 1 mg/day of study treatment. Patients showing poor tolerability for the escalated doses of tasquinimod were allowed to continue study treatment at the highest individually tolerated dose"
721451|NCT01732510|B8|Baseline|Total|Total of all reporting groups
721452|NCT01732510|B7|Baseline|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721453|NCT01732510|B6|Baseline|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721454|NCT01732510|B5|Baseline|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
721455|NCT01732510|B4|Baseline|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721456|NCT01732510|B3|Baseline|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721457|NCT01732510|B2|Baseline|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721458|NCT01732510|B1|Baseline|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721459|NCT01732510|P7|Participant Flow|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721460|NCT01732510|P6|Participant Flow|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721461|NCT01732510|P5|Participant Flow|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
721462|NCT01732510|P4|Participant Flow|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721463|NCT01732510|P3|Participant Flow|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721464|NCT01732510|P2|Participant Flow|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721465|NCT01732510|P1|Participant Flow|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721466|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721467|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721468|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks. No participant met criteria for inclusion in the evaluable population.
721469|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721470|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721471|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721472|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721473|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721474|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721475|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721476|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721477|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721478|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721480|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721481|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721482|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721483|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721484|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721485|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721486|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721487|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721488|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721489|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721490|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721491|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721492|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721493|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721494|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721495|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721496|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721497|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721498|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721499|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721500|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721501|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721502|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721503|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721504|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721505|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721506|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721507|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721508|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721509|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721510|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721511|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721512|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721513|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721514|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721515|NCT01732510|O2|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721516|NCT01732510|O1|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721517|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
721518|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721519|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721520|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721521|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721522|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721523|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721524|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
721525|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721526|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721527|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721528|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721529|NCT01732510|O7|Outcome|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721530|NCT01732510|O6|Outcome|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721531|NCT01732510|O5|Outcome|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
721532|NCT01732510|O4|Outcome|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721533|NCT01732510|O3|Outcome|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721534|NCT01732510|O2|Outcome|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721535|NCT01732510|O1|Outcome|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered intravenously (IV) at a weight-based dose every 2 weeks for a period of 12 weeks.
721536|NCT01732510|E7|Reported Event|Part 2: Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
721537|NCT01732510|E6|Reported Event|Part 2: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721538|NCT01732510|E5|Reported Event|Part 1: Placebo (Pooled)|Dose-matched placebo administered IV every 2 weeks for a period of 12 weeks.
721539|NCT01732510|E4|Reported Event|Part 1: MK-8226 10 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721540|NCT01732510|E3|Reported Event|Part 1: MK-8226 3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721541|NCT01732510|E2|Reported Event|Part 1: MK-8226 1 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721542|NCT01732510|E1|Reported Event|Part 1: MK-8226 0.3 mg/kg|MK-8226 administered IV at a weight-based dose every 2 weeks for a period of 12 weeks.
721543|NCT01732484|B1|Baseline|Cataract Surgery|eyes with implantation of iMics1 NY-60 IOL or Acrysof SN60WF IOL
721544|NCT01732484|P1|Participant Flow|Patients Included|
721545|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
721546|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
721547|NCT01732484|O2|Outcome|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
721548|NCT01732484|O1|Outcome|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
721549|NCT01732484|E2|Reported Event|AcrySof SN60WF|eyes with implantation of AcrySof SN60WF IOL
721550|NCT01732484|E1|Reported Event|iMics1 NY-60|eyes with implantation of iMics1 NY-60 IOL
721551|NCT01732471|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
721552|NCT01732471|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
721553|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
721554|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
721555|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
721556|NCT01732471|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
721557|NCT01732471|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) was administered orally at a dose of 20 mg/kg/day once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment was continued at the same dose for further 6 weeks.
721558|NCT01732263|B3|Baseline|Total|Total of all reporting groups
721559|NCT01732263|B2|Baseline|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721560|NCT01732263|B1|Baseline|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721561|NCT01732263|P2|Participant Flow|Matched Healthy Subjects|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721562|NCT01732263|P1|Participant Flow|Hepatic Impairment|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721563|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721564|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721593|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
722285|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722654|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
721565|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721566|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721567|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721568|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721569|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721570|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721571|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721572|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721573|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721574|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721575|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721576|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721577|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721578|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721579|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721580|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721581|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721582|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721583|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721584|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721585|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721586|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721587|NCT01732263|O6|Outcome|SSP-004184 (Matched Healthy Subjects) 50 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721588|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721589|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721590|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721591|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721592|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721594|NCT01732263|O5|Outcome|SSP-004184 (Matched Healthy Subjects) 45 mg/kg|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted).
721595|NCT01732263|O4|Outcome|SSP-004184 (Child-Pugh C Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721596|NCT01732263|O3|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721597|NCT01732263|O2|Outcome|SSP-004184 (Child-Pugh B Liver Impaired) 45 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721598|NCT01732263|O1|Outcome|SSP-004184 (Child-Pugh A Liver Impaired) 50 mg/kg|"The Child-Pugh Score is a scoring system used to determine the prognosis with cirrhosis and need for liver transplantation. Scoring is based upon albumin, ascites, total bilirubin, prothrombin time, and encephalopathy. Each category is based on a scoring system of 1-3 with 3 being the worst and a total score range of 5-15. It is broken into categories A (score of 5-6), B (score of 7-9), and C (score of 10-15) with worsening from A to C for prognosis.~All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1 (or a revised dose if dose modifications are warranted)."
721599|NCT01732263|E2|Reported Event|Matched Healthy Subjects|
721600|NCT01732263|E1|Reported Event|Hepatic Impairment|
721601|NCT01731938|B5|Baseline|Total|Total of all reporting groups
721602|NCT01731938|B4|Baseline|Surgicel® Part II|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721603|NCT01731938|B3|Baseline|Fibrin Sealant (FS) Grifols Part II|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721604|NCT01731938|B2|Baseline|Surgicel® Part I|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721605|NCT01731938|B1|Baseline|Fibrin Sealant (FS) Grifols Part I|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721606|NCT01731938|P2|Participant Flow|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721607|NCT01731938|P1|Participant Flow|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721608|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721609|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721610|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721611|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721612|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721649|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721613|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721614|NCT01731938|O2|Outcome|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721615|NCT01731938|O1|Outcome|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721616|NCT01731938|E2|Reported Event|Surgicel®|"Surgicel® is a sterile, absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.~Surgicel®: Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice."
721617|NCT01731938|E1|Reported Event|Fibrin Sealant (FS) Grifols|"Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).~Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits)."
721618|NCT01731470|B1|Baseline|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
721619|NCT01731470|P1|Participant Flow|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
721620|NCT01731470|O1|Outcome|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
721621|NCT01731470|O1|Outcome|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
721622|NCT01731470|E1|Reported Event|Liposomes|"Liposomes~Liposomes: Intravesical instillation of liposomes."
721623|NCT01731119|B1|Baseline|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721624|NCT01731119|P1|Participant Flow|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721625|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721626|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721627|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721628|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721629|NCT01731119|O1|Outcome|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721650|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721651|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721630|NCT01731119|E1|Reported Event|Flexible Dose Latuda©|"Lurasidone (Latuda©)dose will be determined solely by the clinician in accordance with the best interests of each participant.~Latuda©: All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant."
721631|NCT01731041|B3|Baseline|Total|Total of all reporting groups
721632|NCT01731041|B2|Baseline|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721633|NCT01731041|B1|Baseline|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721634|NCT01731041|P2|Participant Flow|Ticagrelor 90mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
721635|NCT01731041|P1|Participant Flow|Ticagrelor 180mg|A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).
721636|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721637|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721638|NCT01731041|O2|Outcome|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721639|NCT01731041|O1|Outcome|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721640|NCT01731041|E2|Reported Event|Ticagrelor 90mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721641|NCT01731041|E1|Reported Event|Ticagrelor 180mg|"A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose).~Ticagrelor re-load: A total of 60 subjects will be included in this study and will be randomized in a prospective, double-blind fashion in two treatment groups: 1) 90 mg dose of ticagrelor (active comparator, standard dose); 2) 180 mg of ticagrelor (experimatal arm, loading dose)."
721642|NCT01730378|B3|Baseline|Total|Total of all reporting groups
721643|NCT01730378|B2|Baseline|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721644|NCT01730378|B1|Baseline|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721645|NCT01730378|P2|Participant Flow|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721646|NCT01730378|P1|Participant Flow|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721647|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721648|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721652|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721653|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721654|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721655|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721656|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721657|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721658|NCT01730378|O2|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721659|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721660|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721661|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721662|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721663|NCT01730378|O1|Outcome|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721664|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721665|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721666|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721667|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721668|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721669|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721670|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721671|NCT01730378|O1|Outcome|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721672|NCT01730378|E2|Reported Event|Fluarix Group|Subjects in this group received 1 dose of Fluarix™ vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid region of non-dominant arm.
721673|NCT01730378|E1|Reported Event|Prepandrix Group|Subjects in this group received 2 doses of Prepandrix™ vaccine at Days 0 and 21. The vaccine was administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
721674|NCT01730339|B3|Baseline|Total|Total of all reporting groups
721675|NCT01730339|B2|Baseline|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721676|NCT01730339|B1|Baseline|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721677|NCT01730339|P2|Participant Flow|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 milligrams per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721678|NCT01730339|P1|Participant Flow|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 milligram per linear centimeter (mg/cm) (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721679|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721680|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721681|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721682|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721683|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721684|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721685|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721686|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721687|NCT01730339|O2|Outcome|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721688|NCT01730339|O1|Outcome|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm, (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721689|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
721690|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
721691|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
721692|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
721693|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
721694|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
721695|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
721696|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
721697|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
721698|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
721699|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast, and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
721700|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
721701|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, also received 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
721702|NCT01730339|O3|Outcome|Group 2: PF-06473871: (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
721703|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast
721704|NCT01730339|O1|Outcome|Group 1: PF-06473871: (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
721705|NCT01730339|O4|Outcome|Group 2: Placebo 3* 5 mg/cm|Participants who received 3 intradermal injections of PF-06473871 on one breast, and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, and 8 on another breast.
721706|NCT01730339|O3|Outcome|Group 2: PF¬06473871: 3* 5 mg/cm|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, and 8.
721707|NCT01730339|O2|Outcome|Group 1: Placebo 4* 5 mg/cm|Participants who received 4 intradermal injections of PF-06473871 on one breast and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8, and 11 on another breast.
721708|NCT01730339|O1|Outcome|Group 1: PF-06473871: 4* 5 mg/cm|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm ( 2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8, and 11.
721709|NCT01730339|E2|Reported Event|PF-06473871/Placebo (3* 5 mg/cm)|Participants with bilateral hypertrophic scars received 3 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5 and 8; and 3 intradermal injections of placebo matched to PF-06473871 at Week 2, 5 and 8 on another breast.
721710|NCT01730339|E1|Reported Event|PF-06473871/Placebo (4* 5 mg/cm)|Participants with bilateral hypertrophic scars received 4 intradermal injections of PF-06473871 at a dose of 5 mg/cm (2.5 mg on each side of the revised scar) on one breast at Week 2, 5, 8 and 11; and 4 intradermal injections of placebo matched to PF-06473871 at Week 2, 5, 8 and 11 on another breast.
721711|NCT01730053|B7|Baseline|Total|Total of all reporting groups
721712|NCT01730053|B6|Baseline|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721713|NCT01730053|B5|Baseline|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721714|NCT01730053|B4|Baseline|Rosuvastatin 40 mg|.Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721715|NCT01730053|B3|Baseline|Alirocumab 75/up to 150 + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721716|NCT01730053|B2|Baseline|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721717|NCT01730053|B1|Baseline|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721718|NCT01730053|P6|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721719|NCT01730053|P5|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721720|NCT01730053|P4|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721721|NCT01730053|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721722|NCT01730053|P2|Participant Flow|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721723|NCT01730053|P1|Participant Flow|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablet orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721741|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721724|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721725|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721726|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721727|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721728|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721729|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721730|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721731|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721732|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721733|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721734|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721735|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721736|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721737|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721738|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721739|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721740|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722090|NCT01729728|O3|Outcome|TL Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
721742|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721743|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721744|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721745|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721746|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721747|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721748|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721749|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721750|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721751|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721752|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721753|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721754|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721755|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721756|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721757|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721758|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
721759|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721760|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721761|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721762|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721763|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721764|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721765|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721766|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721767|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721768|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721769|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721770|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721771|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721772|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721773|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721774|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721775|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721776|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722091|NCT01729728|O2|Outcome|TL Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
721777|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721778|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721779|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
721780|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721781|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721782|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721783|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721784|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721785|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721786|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721787|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721788|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721789|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721790|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721791|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721792|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721793|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721794|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721795|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721796|NCT01730053|O6|Outcome|Alirocumab 75 mg/ up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721797|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721798|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721799|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721800|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721801|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721802|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721803|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721804|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721805|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721806|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721807|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721808|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721809|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721810|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721811|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722092|NCT01729728|O1|Outcome|TL Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
721812|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721813|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721814|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721815|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721816|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721817|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721818|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721819|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721820|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721821|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721822|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721823|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721824|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721825|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721826|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721827|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721828|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721846|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
724157|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
721829|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721830|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721831|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721832|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721833|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721834|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721835|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721836|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721837|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721838|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721839|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721840|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721841|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721842|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721843|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721844|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721845|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
722093|NCT01729728|O3|Outcome|ALP Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
721847|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721848|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721849|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721850|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721851|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721852|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721853|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721854|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721855|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721856|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721857|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
721858|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721859|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721860|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721861|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721862|NCT01730053|O6|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg Q2W SC injection, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721863|NCT01730053|O5|Outcome|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 20 mg over-encapsulated tablet orally QD, and placebo for alirocumab Q2W SC injection added to stable LMT for 24 weeks.
722094|NCT01729728|O2|Outcome|ALP Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
721864|NCT01730053|O4|Outcome|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg over-encapsulated tablet orally at baseline, received rosuvastatin 40 mg over-encapsulated tablet orally QD, placebo for alirocumab Q2W SC injection, and placebo for ezetimibe QD over-encapsulated tablet orally added to stable LMT for 24 weeks.
721865|NCT01730053|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received alirocumab 75 mg SC injection Q2W, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721866|NCT01730053|O2|Outcome|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received ezetimibe 10 mg over-encapsulated tablet orally QD, rosuvastatin 10 mg over-encapsulated tablet orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721867|NCT01730053|O1|Outcome|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg over-encapsulated tablet orally at baseline, received rosuvastatin 20 mg over-encapsulated tablet orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablet orally QD added to stable LMT for 24 weeks.
721868|NCT01730053|E6|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 10 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721869|NCT01730053|E5|Reported Event|Ezetimibe 10 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 20 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
721870|NCT01730053|E4|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received rosuvastatin 40 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
721871|NCT01730053|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 20 mg at baseline, received alirocumab 75 mg Q2W, rosuvastatin 20 mg QD, and placebo for ezetimibe QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721872|NCT01730053|E2|Reported Event|Ezetimibe 10 mg + Rosuvastatin 10 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received ezetimibe 10 mg QD, rosuvastatin 10 mg QD, and placebo for alirocumab Q2W added to stable LMT for 24 weeks.
721873|NCT01730053|E1|Reported Event|Rosuvastatin 20 mg|Participants, who were receiving rosuvastatin 10 mg at baseline, received rosuvastatin 20 mg QD, placebo for alirocumab Q2W, and placebo for ezetimibe QD added to stable LMT for 24 weeks.
721874|NCT01730040|B8|Baseline|Total|Total of all reporting groups
721875|NCT01730040|B7|Baseline|Alirocumab 75 mg/ up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721876|NCT01730040|B6|Baseline|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721877|NCT01730040|B5|Baseline|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721878|NCT01730040|B4|Baseline|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721879|NCT01730040|B3|Baseline|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721880|NCT01730040|B2|Baseline|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721881|NCT01730040|B1|Baseline|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721882|NCT01730040|P7|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722095|NCT01729728|O1|Outcome|ALP Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722701|NCT01727141|O4|Outcome|Placebo|b.i.d
721883|NCT01730040|P6|Participant Flow|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721884|NCT01730040|P5|Participant Flow|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721885|NCT01730040|P4|Participant Flow|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721886|NCT01730040|P3|Participant Flow|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721887|NCT01730040|P2|Participant Flow|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721888|NCT01730040|P1|Participant Flow|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721889|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721890|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721891|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721892|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721893|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721894|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721895|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721896|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721897|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721898|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721899|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721934|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
724158|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
721900|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721901|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721902|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721903|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721904|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721905|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721906|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721907|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721908|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721909|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721910|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721911|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721912|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721913|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721914|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721915|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721916|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722079|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
721917|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721918|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721919|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721920|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721921|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721922|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721923|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721924|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721925|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721926|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721927|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721928|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721929|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721930|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721931|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721932|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721933|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722080|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
724159|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
721935|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721936|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721937|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721938|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721939|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721940|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721941|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721942|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721943|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721944|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721945|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721946|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721947|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721948|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721949|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721950|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721951|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722081|NCT01729871|E2|Reported Event|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
721952|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721953|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721954|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721955|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721956|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721957|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721958|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721959|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721960|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721961|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721962|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721963|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721964|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721965|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721966|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721967|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721968|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722082|NCT01729871|E1|Reported Event|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
722083|NCT01729728|B4|Baseline|Total|Total of all reporting groups
721969|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721970|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721971|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721972|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721973|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721974|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721975|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721976|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721977|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721978|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721979|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721980|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721981|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721982|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721983|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721984|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721985|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722084|NCT01729728|B3|Baseline|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722702|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
721986|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721987|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721988|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721989|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721990|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721991|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721992|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721993|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
721994|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721995|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
721996|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721997|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
721998|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
721999|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722000|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722001|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722002|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722085|NCT01729728|B2|Baseline|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722003|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722004|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722005|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722006|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722007|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722008|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722009|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722010|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722011|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722012|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722013|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722014|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722015|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722016|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722017|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722018|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722019|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722086|NCT01729728|B1|Baseline|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
724160|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
722020|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722021|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722022|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722023|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722024|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722025|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722026|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722027|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722028|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722029|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722030|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722031|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722032|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722033|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722034|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722035|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722036|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722087|NCT01729728|P3|Participant Flow|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight)
722037|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722038|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722039|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722040|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722041|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722042|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722043|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722044|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722045|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722046|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722047|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722048|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722049|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722050|NCT01730040|O7|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722051|NCT01730040|O6|Outcome|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722052|NCT01730040|O5|Outcome|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722053|NCT01730040|O4|Outcome|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722088|NCT01729728|P2|Participant Flow|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
722089|NCT01729728|P1|Participant Flow|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight)
724161|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
722054|NCT01730040|O3|Outcome|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722055|NCT01730040|O2|Outcome|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722056|NCT01730040|O1|Outcome|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722057|NCT01730040|E7|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received alirocumab 75 mg SC injection Q2W, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722058|NCT01730040|E6|Reported Event|Ezetimibe 10 mg + Atorvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 40 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection.Q2W added to stable LMT for 24 weeks.
722059|NCT01730040|E5|Reported Event|Rosuvastatin 40 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received rosuvastatin 40 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722060|NCT01730040|E4|Reported Event|Atorvastatin 80 mg|Participants, who were receiving atorvastatin 40 mg over-encapsulated tablets orally at baseline, received Atorvastatin 80 mg over-encapsulated tablets orally QD, placebo for alirocumab SC injection Q2W, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks.
722061|NCT01730040|E3|Reported Event|Alirocumab 75 mg/up to 150 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received Alirocumab 75 mg SC injection Q2W, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for ezetimibe over-encapsulated tablets orally QD added to stable LMT for 24 weeks. Alirocumab dose up¬-titrated to 150 mg Q2W from Week 12 when LDL-¬C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on baseline disease characteristic and medical history.
722062|NCT01730040|E2|Reported Event|Ezetimibe 10 mg + Atorvastatin 20 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received ezetimibe 10 mg over-encapsulated tablets orally QD, atorvastatin 20 mg over-encapsulated tablets orally QD, and placebo for alirocumab SC injection Q2W added to stable LMT for 24 weeks.
722063|NCT01730040|E1|Reported Event|Atorvastatin 40 mg|Participants, who were receiving atorvastatin 20 mg over-encapsulated tablets orally at baseline, received atorvastatin 40 mg over-encapsulated tablets orally once daily (QD), placebo for alirocumab SC injection every two weeks (Q2W), and placebo for ezetimibe over-encapsulated tablets orally QD added to stable Lipid-Modifying Therapy (LMT) for 24 weeks.
722064|NCT01729871|B3|Baseline|Total|Total of all reporting groups
722065|NCT01729871|B2|Baseline|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
722066|NCT01729871|B1|Baseline|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
722067|NCT01729871|P2|Participant Flow|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
722068|NCT01729871|P1|Participant Flow|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
722069|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
722070|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
722071|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
722072|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
722073|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
722074|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
722075|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
722076|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
722077|NCT01729871|O2|Outcome|Vitamin K Antagonist|Participants were received dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0 for 8-10 weeks.
722078|NCT01729871|O1|Outcome|Rivaroxaban|Participants were received Rivaroxaban 20 milligram (mg) orally once-daily administered preferably with the evening meal for 8-10 weeks.
724162|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
722096|NCT01729728|O3|Outcome|CK Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722097|NCT01729728|O2|Outcome|CK Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722098|NCT01729728|O1|Outcome|CK Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722099|NCT01729728|O3|Outcome|Protein Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722100|NCT01729728|O2|Outcome|Protein Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722101|NCT01729728|O1|Outcome|Protein Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722102|NCT01729728|O3|Outcome|LDH Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722103|NCT01729728|O2|Outcome|LDH Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722104|NCT01729728|O1|Outcome|LDH Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722105|NCT01729728|O3|Outcome|Bilirubin Concentration: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722106|NCT01729728|O2|Outcome|Bilirubin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722107|NCT01729728|O1|Outcome|Bilirubin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722108|NCT01729728|O3|Outcome|GGT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722109|NCT01729728|O2|Outcome|GGT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722110|NCT01729728|O1|Outcome|GGT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722111|NCT01729728|O3|Outcome|ALT Activity: Young & Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722112|NCT01729728|O2|Outcome|ALT Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722113|NCT01729728|O1|Outcome|ALT Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722114|NCT01729728|O3|Outcome|Urine pH: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722115|NCT01729728|O2|Outcome|Urine pH: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722116|NCT01729728|O1|Outcome|Urine pH: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722117|NCT01729728|O3|Outcome|Specific Gravity Urine: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722118|NCT01729728|O2|Outcome|Specific Gravity Urine: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722119|NCT01729728|O1|Outcome|Specific Gravity Urine: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722120|NCT01729728|O3|Outcome|Glomerular Filtration Rate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722121|NCT01729728|O2|Outcome|Glomerular Filtration Rate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722122|NCT01729728|O1|Outcome|Glomerular Filtration Rate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722123|NCT01729728|O3|Outcome|Urate: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722124|NCT01729728|O2|Outcome|Urate: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722125|NCT01729728|O1|Outcome|Urate: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722126|NCT01729728|O3|Outcome|Albumin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722127|NCT01729728|O2|Outcome|Albumin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722128|NCT01729728|O1|Outcome|Albumin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722286|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722129|NCT01729728|O3|Outcome|Triglycerides Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722130|NCT01729728|O2|Outcome|Triglycerides Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722131|NCT01729728|O1|Outcome|Triglycerides Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722132|NCT01729728|O3|Outcome|AST Activity: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722133|NCT01729728|O2|Outcome|AST Activity: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722134|NCT01729728|O1|Outcome|AST Activity: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722135|NCT01729728|O3|Outcome|Creatinine Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722136|NCT01729728|O2|Outcome|Creatinine Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722137|NCT01729728|O1|Outcome|Creatinine Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722138|NCT01729728|O3|Outcome|BUN Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722139|NCT01729728|O2|Outcome|BUN Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722140|NCT01729728|O1|Outcome|BUN Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722141|NCT01729728|O3|Outcome|Blood Phosphate Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722142|NCT01729728|O2|Outcome|Blood Phosphate Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722143|NCT01729728|O1|Outcome|Blood Phosphate Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722144|NCT01729728|O3|Outcome|Blood Chloride Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722145|NCT01729728|O2|Outcome|Blood Chloride Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722146|NCT01729728|O1|Outcome|Blood Chloride Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722147|NCT01729728|O3|Outcome|Blood Calcium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722148|NCT01729728|O2|Outcome|Blood Calcium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722149|NCT01729728|O1|Outcome|Blood Calcium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722150|NCT01729728|O3|Outcome|Blood Potassium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722151|NCT01729728|O2|Outcome|Blood Potassium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722152|NCT01729728|O1|Outcome|Blood Potassium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722153|NCT01729728|O3|Outcome|Blood Sodium Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722154|NCT01729728|O2|Outcome|Blood Sodium Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722155|NCT01729728|O1|Outcome|Blood Sodium Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722156|NCT01729728|O3|Outcome|Blood Glucose Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722157|NCT01729728|O2|Outcome|Blood Glucose Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722158|NCT01729728|O1|Outcome|Blood Glucose Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722159|NCT01729728|O3|Outcome|Leukocyte Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722160|NCT01729728|O2|Outcome|Leukocyte Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722290|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722161|NCT01729728|O1|Outcome|Leukocyte Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722162|NCT01729728|O3|Outcome|Platelet Count: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722163|NCT01729728|O2|Outcome|Platelet Count: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722164|NCT01729728|O1|Outcome|Platelet Count: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722165|NCT01729728|O3|Outcome|Mean Corpuscular Volume: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722166|NCT01729728|O2|Outcome|Mean Corpuscular Volume: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722167|NCT01729728|O1|Outcome|Mean Corpuscular Volume: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722168|NCT01729728|O3|Outcome|Hematocrit: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722169|NCT01729728|O2|Outcome|Hematocrit: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722170|NCT01729728|O1|Outcome|Hematocrit: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722171|NCT01729728|O3|Outcome|Hemoglobin Concentration: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722172|NCT01729728|O2|Outcome|Hemoglobin Concentration: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722173|NCT01729728|O1|Outcome|Hemoglobin Concentration: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722174|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Tmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722175|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722176|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722177|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Tmax|Tapentadol oral solution single dose (1mg/kg body weight) of participants aged 12 years to less than 18 years old.
722178|NCT01729728|O3|Outcome|Young and Very Young Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722179|NCT01729728|O2|Outcome|Older Children With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722180|NCT01729728|O1|Outcome|Adolescents With Supplementary Analgesic|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722181|NCT01729728|O3|Outcome|Number of TEAEs: Young and Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 6 years of age.
722182|NCT01729728|O2|Outcome|Number of TEAEs: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
722183|NCT01729728|O1|Outcome|Number of TEAEs: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
722184|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: Cmax|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722185|NCT01729728|O3|Outcome|ECG Heart Rate Change: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722186|NCT01729728|O2|Outcome|ECG Heart Rate Change: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722187|NCT01729728|O1|Outcome|ECG Heart Rate Change: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722188|NCT01729728|O3|Outcome|ECG Changes: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722189|NCT01729728|O2|Outcome|ECG Changes: Older Children|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722190|NCT01729728|O1|Outcome|ECG Changes: Adolescents|Single Dose of Tapentadol Oral Solution in Children and Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722191|NCT01729728|O3|Outcome|Blood Pressure: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722192|NCT01729728|O2|Outcome|Blood Pressure: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722193|NCT01729728|O1|Outcome|Blood Pressure: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722703|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722194|NCT01729728|O3|Outcome|Oxygen Saturation: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722195|NCT01729728|O2|Outcome|Oxygen Saturation: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722196|NCT01729728|O1|Outcome|Oxygen Saturation: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722197|NCT01729728|O3|Outcome|Respiratory Rates: Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722198|NCT01729728|O2|Outcome|Respiratory Rates: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722199|NCT01729728|O1|Outcome|Respiratory Rates: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722200|NCT01729728|O1|Outcome|Tapentadol Non-Compartmental PK Parameter: AUC|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722201|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
722202|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Very Young Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 2 years and less than 3 years of age.
722203|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
722204|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Younger Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 3 years and less than 6 years of age.
722205|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
722206|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Older Children|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 6 years and less than 12 years of age.
722207|NCT01729728|O1|Outcome|Tapentadol-O-glucuronide Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
722208|NCT01729728|O1|Outcome|Sum of Pain Intensity Differences|"The sum of pain intensity difference over 4 hours (SPID4) were calculated as the weighted sum of the scheduled pain intensity difference collected up to 4 hours after tapentadol oral solution administration.~The time elapsed (in hours) since the previous measurement is multiplied with the pain intensity difference (PID) at the respective time, and defines the weight in the calculation of the weighted sum of pain intensity differences."
722209|NCT01729728|O1|Outcome|Face, Legs, Activity, Cry, Consolability Scale|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722210|NCT01729728|O2|Outcome|Faces Pain Scale: Young Children|Single Dose of Tapentadol Oral Solution in Children Age 3 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight). The children aged 2 were assessed using the FLACC (Face, Legs, Activity, Cry, Consolability) Scale and not the 6-point Faces Pain Scale - Revised.
722211|NCT01729728|O1|Outcome|Faces Pain Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight)
722212|NCT01729728|O2|Outcome|McGrath Color Analog Scale: Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722213|NCT01729728|O1|Outcome|McGrath Color Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722214|NCT01729728|O1|Outcome|Visual Analog Scale: Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722215|NCT01729728|O1|Outcome|Tapentadol Serum Concentrations: Adolescents|Tapentadol oral solution single dose (1mg/kg body weight). Participants aged 12 years and less than 18 years of age.
722216|NCT01729728|E3|Reported Event|Young and Very Young Children|Single Dose of Tapentadol Oral Solution in Children Age 2 to Less Than 6 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722217|NCT01729728|E2|Reported Event|Older Children|Single Dose of Tapentadol Oral Solution in Children Age 6 to Less Than 12 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722218|NCT01729728|E1|Reported Event|Adolescents|Single Dose of Tapentadol Oral Solution in Adolescents Age 12 to Less Than 18 Years. Tapentadol oral solution single dose (1mg/kg body weight).
722219|NCT01729559|B3|Baseline|Total|Total of all reporting groups
722220|NCT01729559|B2|Baseline|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
722221|NCT01729559|B1|Baseline|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
722222|NCT01729559|P2|Participant Flow|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
722223|NCT01729559|P1|Participant Flow|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
724163|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
722224|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
722225|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
722226|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
722227|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
722228|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
722229|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
722230|NCT01729559|O2|Outcome|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
722231|NCT01729559|O1|Outcome|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
722232|NCT01729559|E2|Reported Event|30mg Enoxaparin Q12 Hours|"Randomly assigned trauma patients to receive Low Molecular Weight Heparin (30mg enoxaparin) given subcutaneously every twelve hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~30mg enoxaparin Q12 hours: Venous thromboembolic prophylaxis"
722233|NCT01729559|E1|Reported Event|5000 Units Unfractionated Heparin Q 8 Hours|"Low Dose Unfractionated Heparin (5000 Units) given every eight hours until primary or secondary outcome measure reached, discharge, or >30 days on trauma service.~5000 Units unfractionated Heparin Q 8 hours: Venous thromboembolic prophylaxis medication. Patients were randomly assigned."
722234|NCT01729338|B1|Baseline|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722235|NCT01729338|P1|Participant Flow|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722236|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722262|NCT01729247|E1|Reported Event|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
722263|NCT01729026|B3|Baseline|Total|Total of all reporting groups
722287|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722288|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722289|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722237|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722238|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722239|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722240|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722241|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722242|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722243|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722281|NCT01728792|P2|Participant Flow|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722282|NCT01728792|P1|Participant Flow|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722283|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722244|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722245|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722246|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722247|NCT01729338|O1|Outcome|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722248|NCT01729338|E1|Reported Event|Velcade, Cyclophosphamide, Revlimid|"INDUCTION (28-day cycles for 8 cycles):~VELCADE 1.3 mg/m2 subcutaneously (SC) days 1, 8 and 15~Cyclophosphamide 300 mg/m2 orally (PO) days 1, 8 and 15~Dexamethasone 40 mg PO days 1,8 and 15~MAINTENANCE (28-day alternating cycles until stopped for toxicity, relapse or death):~Odd cycles (9, 11, 13, etc.) lenalidomide 10 mg PO days 1-21~Even cycles (10, 12, 14, etc.) VELCADE 1.3 mg/m2 SC days 1, 15~Velcade: Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until"
722249|NCT01729247|B1|Baseline|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
722250|NCT01729247|P1|Participant Flow|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
722251|NCT01729247|O1|Outcome|FeNO|Participants with asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.
722252|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
722253|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
722254|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
722255|NCT01729247|O3|Outcome|High Airway Inflammation|As categorized by physician assessment
722256|NCT01729247|O2|Outcome|Intermediate Airway Inflammation|As categorized by physician assessment
722257|NCT01729247|O1|Outcome|Low Airway Inflammation|As categorized by physician assessment
722258|NCT01729247|O2|Outcome|No ICS Use|Participants that did not use inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
722259|NCT01729247|O1|Outcome|ICS Use|Participants that used inhaled corticosteroids (ICS) or ICS/long-acting beta-agonist (LABA)
722260|NCT01729247|O2|Outcome|High ACT Score|Participants who had an asthma control test (ACT) score of >19, which indicates well-controlled asthma
722261|NCT01729247|O1|Outcome|Low ACT Score|Participants who had an asthma control test (ACT) score of <=19, which indicates less well-controlled asthma
722284|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
724164|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
722264|NCT01729026|B2|Baseline|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722265|NCT01729026|B1|Baseline|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722266|NCT01729026|P2|Participant Flow|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722267|NCT01729026|P1|Participant Flow|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722268|NCT01729026|O2|Outcome|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722269|NCT01729026|O1|Outcome|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722270|NCT01729026|E2|Reported Event|Wait-list, Then Adoption After 3 Months|"After 3 months on a wait-list, Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722271|NCT01729026|E1|Reported Event|Shelter Dog Adoption|"Veterans will choose a dog from the San Antonio Humane Society with the help of a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.~Shelter Dog Adoption: Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian."
722272|NCT01728792|B6|Baseline|Total|Total of all reporting groups
722273|NCT01728792|B5|Baseline|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722274|NCT01728792|B4|Baseline|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722275|NCT01728792|B3|Baseline|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722276|NCT01728792|B2|Baseline|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722277|NCT01728792|B1|Baseline|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722278|NCT01728792|P5|Participant Flow|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722279|NCT01728792|P4|Participant Flow|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722280|NCT01728792|P3|Participant Flow|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722291|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722292|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722293|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722294|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722295|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722296|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722297|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722298|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722299|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722300|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722301|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722302|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722303|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722304|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722305|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722306|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722307|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722308|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722309|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722310|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722311|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722312|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722313|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722314|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722315|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722316|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722317|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722318|NCT01728792|O5|Outcome|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722319|NCT01728792|O4|Outcome|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722320|NCT01728792|O3|Outcome|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722321|NCT01728792|O2|Outcome|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722322|NCT01728792|O1|Outcome|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722323|NCT01728792|E5|Reported Event|Group 5: TDV IM_2 Doses Day 0|TDV, 0.5 mL, IM injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722324|NCT01728792|E4|Reported Event|Group 4: TDV SC_2 Doses Day 0|TDV, 0.5 mL, SC injection, one dose in each arm, Day 0 using PharmaJet Stratis™ device.
722325|NCT01728792|E3|Reported Event|Group 3: TDV IM_2 Doses Days 0 and 90|TDV, 0.5 mL, IM injection, one dose on Day 0 and one dose on Day 90 using needle/syringe.
722326|NCT01728792|E2|Reported Event|Group 2: TDV IM_2 Doses Day 0|TDV, 0.5 mL, intramuscular (IM) injection, one dose in each arm, Day 0 using needle/syringe.
722327|NCT01728792|E1|Reported Event|Group 1: TDV SC_ 2 Doses Day 0|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous (SC) injection, one dose in each arm, Day 0 using needle/syringe.
722328|NCT01728584|B5|Baseline|Total|Total of all reporting groups
722329|NCT01728584|B4|Baseline|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722330|NCT01728584|B3|Baseline|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722331|NCT01728584|B2|Baseline|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722332|NCT01728584|B1|Baseline|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722333|NCT01728584|P4|Participant Flow|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722334|NCT01728584|P3|Participant Flow|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 Post Tetanic Counts [PTCs])/Standard insufflation pressure (starting pressure of 12 mmHg).
722335|NCT01728584|P2|Participant Flow|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722336|NCT01728584|P1|Participant Flow|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard (Std) NMB (depth of blockade at a targeted Train of Four [TOF] ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722337|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722338|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722339|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722340|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722341|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722342|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722343|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722344|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722345|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722346|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722347|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722348|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722349|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722350|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722351|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722352|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722353|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722354|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722355|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722356|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722357|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
722358|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
722359|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
722385|NCT01728584|E2|Reported Event|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722360|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
722361|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
722362|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
722363|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
722364|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
722365|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
722366|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
722367|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722368|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722369|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722370|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722371|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
722372|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
722373|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
722374|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
722375|NCT01728584|O4|Outcome|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722376|NCT01728584|O3|Outcome|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722377|NCT01728584|O2|Outcome|Standard NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Low insufflation pressure (starting pressure of 8 mmHg).
722378|NCT01728584|O1|Outcome|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722379|NCT01728584|O4|Outcome|Low Insufflation Pressure|Treatment condition for this reporting group is Low insufflation pressure (starting pressure of 8 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Low insufflation pressure and Deep NMB/Low insufflation pressure.
722380|NCT01728584|O3|Outcome|Standard Insufflation Pressure|Treatment condition for this reporting group is Standard insufflation pressure (starting pressure of 12 mmHg), whether in combination with Standard or Deep NMB. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Deep NMB/Standard insufflation pressure.
722381|NCT01728584|O2|Outcome|Deep NMB|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Deep NMB/Standard insufflation pressure and Deep NMB/Low insufflation pressure.
722382|NCT01728584|O1|Outcome|Standard NMB|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%), whether in combination with Standard or Low insufflation pressure. Therefore, the included arms are Standard NMB/Standard insufflation pressure and Standard NMB/Low insufflation pressure.
722383|NCT01728584|E4|Reported Event|Deep NMB and Low Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Low insufflation pressure (starting pressure of 8 mmHg).
722384|NCT01728584|E3|Reported Event|Deep NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Deep NMB (depth of blockade of 1-2 PTCs)/Standard insufflation pressure (starting pressure of 12 mmHg).
722386|NCT01728584|E1|Reported Event|Standard NMB and Standard Insufflation Pressure|Treatment condition for this reporting group is Standard NMB (depth of blockade at a targeted TOF ratio of 10%)/Standard insufflation pressure (starting pressure of 12 mmHg).
722387|NCT01728376|B7|Baseline|Total|Total of all reporting groups
722388|NCT01728376|B6|Baseline|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722389|NCT01728376|B5|Baseline|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722390|NCT01728376|B4|Baseline|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722391|NCT01728376|B3|Baseline|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722392|NCT01728376|B2|Baseline|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722393|NCT01728376|B1|Baseline|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722394|NCT01728376|P6|Participant Flow|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722395|NCT01728376|P5|Participant Flow|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722396|NCT01728376|P4|Participant Flow|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722397|NCT01728376|P3|Participant Flow|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722398|NCT01728376|P2|Participant Flow|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722399|NCT01728376|P1|Participant Flow|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722400|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722401|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722402|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722403|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722649|NCT01727258|P3|Participant Flow|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
722404|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722405|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722406|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722407|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722408|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722409|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722410|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722411|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722412|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722413|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722414|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722415|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722416|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722417|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722418|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722419|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722420|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722421|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722422|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722423|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722424|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722425|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722426|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722427|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722428|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722429|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722430|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722431|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722432|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722433|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722434|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722435|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722436|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722437|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722650|NCT01727258|P2|Participant Flow|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
722438|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722439|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722440|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722441|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722442|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722443|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722444|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722445|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722446|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722447|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722448|NCT01728376|O6|Outcome|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722449|NCT01728376|O5|Outcome|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722450|NCT01728376|O4|Outcome|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722451|NCT01728376|O3|Outcome|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722452|NCT01728376|O2|Outcome|Comparator- 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722453|NCT01728376|O1|Outcome|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722454|NCT01728376|E6|Reported Event|Comparator - 12 to 17 Year Olds|Participants ages 12-17 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722455|NCT01728376|E5|Reported Event|Daptomycin - 12 to 17 Year Olds|Participants ages 12-17 years old were administered daptomycin 7 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-42 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722456|NCT01728376|E4|Reported Event|Comparator - 7 to 11 Year Olds|Participants ages 7-11 years old received IV vancomycin or semi-synthetic penicillin or first-generation cephalosporins or clindamycin, given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722457|NCT01728376|E3|Reported Event|Daptomycin - 7 to 11 Year Olds|Participants ages 7-11 years old were administered daptomycin 9 mg/kg infused once daily, intravenously, over 30 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722458|NCT01728376|E2|Reported Event|Comparator - 1 to 6 Year Olds|Participants ages 1-6 years old received IV vancomycin, or semi-synthetic penicillin, or first-generation cephalosporins, clindamycin; given as per local guidelines or site-specific prescribing information; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. IV comparator and subsequent oral therapy were at the discretion of the investigator.
722459|NCT01728376|E1|Reported Event|Daptomycin - 1 to 6 Year Olds|Participants ages 1 to 6 years old were administered daptomycin 12 mg/kg, infused once daily, intravenously (IV) over 60 minutes; therapy duration (uncomplicated bacteremia) = 5-28 days, therapy duration (complicated bacteremia) = 7-28 days. After conclusion of IV therapy, can continue on oral therapy (not daptomycin, but at discretion of investigator).
722460|NCT01728337|B1|Baseline|Xeomin and Dysport|Xeomin® was injected on the one side of the forehead and Dysport® was injected on the other side of the forehead.
722461|NCT01728337|P1|Participant Flow|Dysport and Xeomin|Dysport® was injected on the one side of the forehead and Xeomin® was injected on the other side of the forehead.
722462|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
722463|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
722464|NCT01728337|O2|Outcome|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
722465|NCT01728337|O1|Outcome|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
722466|NCT01728337|E2|Reported Event|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead.
722467|NCT01728337|E1|Reported Event|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
722468|NCT01728324|B4|Baseline|Total|Total of all reporting groups
722469|NCT01728324|B3|Baseline|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
722470|NCT01728324|B2|Baseline|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
722471|NCT01728324|B1|Baseline|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
722472|NCT01728324|P3|Participant Flow|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
722473|NCT01728324|P2|Participant Flow|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
722474|NCT01728324|P1|Participant Flow|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
722475|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
722476|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
722477|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
722478|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
722479|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
722480|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
722481|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
722482|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
722483|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
722484|NCT01728324|O3|Outcome|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
722485|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
722486|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
722487|NCT01728324|O2|Outcome|16-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|This is the combination of 16 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients and for 24 weeks in cirrhotic patients
722488|NCT01728324|O1|Outcome|24-wk Non-cirrhotic (NC)+24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic and cirrhotic patients.
722489|NCT01728324|E3|Reported Event|24-wk Cirrhotic (CR) Treatment Group|24 weeks of treatment with 600mg BID deleobuvir (DBV) in combination with 120mg QD faldaprevir (FDV) plus ribavirin (RBV) in cirrhotic patients.
722490|NCT01728324|E2|Reported Event|16-wk Non-cirrhotic (NC) Treatment Group|Matching placebo to DBV, Matching placebo to FDV and Matching placebo to RBV for 8 weeks followed by 600mg BID DBV in combination with 120mg FDV plus RBV for 16 weeks in non-cirrhotic patients.
722491|NCT01728324|E1|Reported Event|24-wk Non-cirrhotic (NC) Treatment Group|24 weeks of treatment with 600mg twice daily (BID) deleobuvir (DBV) in combination with 120mg once a day (QD) faldaprevir (FDV) plus ribavirin (RBV) in non-cirrhotic patients.
722492|NCT01728246|B3|Baseline|Total|Total of all reporting groups
722493|NCT01728246|B2|Baseline|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722494|NCT01728246|B1|Baseline|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722495|NCT01728246|P2|Participant Flow|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722496|NCT01728246|P1|Participant Flow|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722497|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722498|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722499|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722500|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722501|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722502|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722503|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722504|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722505|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722506|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722507|NCT01728246|O2|Outcome|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722508|NCT01728246|O1|Outcome|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722509|NCT01728246|E2|Reported Event|Non-Tramadol/APAP|Celecoxib 200 mg administered orally once daily for 4 weeks.
722510|NCT01728246|E1|Reported Event|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) administered orally once daily for 4 weeks and fixed dose combination of tramadol 37.5 mg/paracetamol 325 mg administered orally thrice daily for 4 weeks as add-on therapy.
722511|NCT01728116|B3|Baseline|Total|Total of all reporting groups
722512|NCT01728116|B2|Baseline|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722513|NCT01728116|B1|Baseline|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
722514|NCT01728116|P2|Participant Flow|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52.
722515|NCT01728116|P1|Participant Flow|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device. Medical Nutritional Therapy (MNT) counseling (as defined by the 2012 American Diabetes Association guidelines) was to be conducted at Baseline then Weeks 13, 26, 39, and 52 for both groups, and additionally at Week 65 for the EndoBarrier group.
722516|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722517|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722518|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722519|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722520|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722521|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722522|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722523|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722524|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722525|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722526|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722527|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722528|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722529|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722530|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722531|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. MITT population without imputation
722532|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
722533|NCT01728116|O2|Outcome|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722534|NCT01728116|O1|Outcome|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
722535|NCT01728116|E2|Reported Event|Sham Control Group|Subjects randomized to the sham control group also underwent an upper endoscopy (without fluoroscopy) according to standard institutional endoscopy practices. Subjects also received a prophylactic dose of antibiotics on Procedure Day.
722536|NCT01728116|E1|Reported Event|EndoBarrier Group|Subjects randomized to the device group received the EndoBarrier Gastrointestinal Liner. Subjects also received a prophylactic dose of antibiotics on Procedure Day. Fluoroscopy was also used in conjunction with endoscopy to aid implantation of the EndoBarrier device.
722537|NCT01727895|B3|Baseline|Total|Total of all reporting groups
722538|NCT01727895|B2|Baseline|Control Group|No intervention
722539|NCT01727895|B1|Baseline|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
722540|NCT01727895|P2|Participant Flow|Control Group|No intervention
722541|NCT01727895|P1|Participant Flow|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
722542|NCT01727895|O2|Outcome|Control Group|No intervention
722543|NCT01727895|O1|Outcome|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
722544|NCT01727895|E2|Reported Event|Control Group|No intervention
722545|NCT01727895|E1|Reported Event|Beta-glucan|"Commercial available Beta-glucan derived from bakers yeast (S. Cerevisiae): Glucan #300® produced by Transferpoint, Columbia, United States. 2 capsules of 500mg Glucan #300®, daily, for seven days.~Beta-glucan (Glucan #300®)"
722546|NCT01727791|B1|Baseline|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722547|NCT01727791|P1|Participant Flow|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722651|NCT01727258|P1|Participant Flow|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
722548|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722549|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722550|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722551|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722552|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722553|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722554|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722555|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722556|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722557|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722558|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722559|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722560|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722561|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722562|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722563|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722564|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722565|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722566|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722567|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722568|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722569|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722570|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722571|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722572|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722573|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722574|NCT01727791|O1|Outcome|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722575|NCT01727791|E1|Reported Event|Pregabalin|Participants received pregabalin 150 milligram (mg) immediate-release (IR) capsule over 12-hour dosing intervals on Day 1, Day 2 and Day 3.
722576|NCT01727713|B1|Baseline|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722577|NCT01727713|P1|Participant Flow|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722578|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722579|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722580|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722581|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722582|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722583|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722584|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722585|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722586|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722587|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722588|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722589|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722590|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722591|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722592|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722593|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722594|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722595|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722596|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722597|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722598|NCT01727713|O1|Outcome|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722599|NCT01727713|E1|Reported Event|Open-label Aripiprazole|All participants in this open-label extension trial were assigned to once-daily aripiprazole, which was flexibly dosed at the discretion of the investigator on the basis of treatment response and medication tolerability.
722600|NCT01727700|B4|Baseline|Total|Total of all reporting groups
722601|NCT01727700|B3|Baseline|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722602|NCT01727700|B2|Baseline|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722603|NCT01727700|B1|Baseline|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722604|NCT01727700|P3|Participant Flow|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722605|NCT01727700|P2|Participant Flow|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722606|NCT01727700|P1|Participant Flow|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722607|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722652|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
722608|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722609|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722610|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722611|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722612|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722613|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722614|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722615|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722616|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722617|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722618|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722619|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722620|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722621|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722622|NCT01727700|O3|Outcome|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722623|NCT01727700|O2|Outcome|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722624|NCT01727700|O1|Outcome|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722625|NCT01727700|E3|Reported Event|Placebo|Participants received matching placebo tablets in the same way as aripiprazole.
722626|NCT01727700|E2|Reported Event|Aripiprazole High Dose|For participants who weighed < 50 kg at baseline, high dose was 10 mg/day. For participants who weighed ≥ 50 kg at baseline, high dose was 20 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was then titrated weekly until the randomized dose was achieved. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722653|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
724165|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
722627|NCT01727700|E1|Reported Event|Aripiprazole Low Dose|For participants who weighed < 50 kg at baseline, low dose was 5 mg/day. For participants who weighed ≥ 50 kg at baseline, low dose was 10 mg/day. All participants randomized to aripiprazole began treatment at 2 mg/day, with the dose titrated to 5 mg/day after 2 days. The dose was titrated to achieve the randomized dose. All participants were to have reached their randomized dose by Week 3 (Day 21) and were to remain on that dose.
722628|NCT01727505|B1|Baseline|Study Population|"This is a crossover study. Infants were randomly assigned to one of two sequences.~Sequence A consisted of 24 hours of Conventional Mechanical Ventilation followed by 24 hours of Volume Guarantee Ventilation.~Sequence B consisted of 24 hours of Volume Guarantee Ventilation followed by 24 hours of Conventional Mechanical Ventilation."
722629|NCT01727505|P2|Participant Flow|Sequence B: Volume Guarantee-Conventional|"This is a crossover study. Each patient is randomly assigned to one of two sequences.~Sequence B consisted of a 24-hour period during which the infant received volume guarantee ventilation followed by a 24 hour period during which the infant received conventional mechanical ventilation."
722630|NCT01727505|P1|Participant Flow|Sequence A: Conventional-Volume Guarantee|"This is a crossover study. Each patient is randomly assigned to one of two sequences.~Sequence A consisted of a 24-hour period during which the infant received conventional mechanical ventilation followed by a 24 hour period during which the infant received volume guarantee ventilation."
722631|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722632|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722633|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722634|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722635|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722636|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722637|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722638|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722639|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722640|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722641|NCT01727505|O2|Outcome|Volume Guarantee Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722642|NCT01727505|O1|Outcome|Conventional Mechanical Ventilation Period|"This is a crossover study that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~The sequence of conventional and volume guarantee ventilation were assigned at random."
722643|NCT01727505|E2|Reported Event|Volume Guarantee Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~These data represent the 24 hours of Volume Guarantee Ventilation."
722644|NCT01727505|E1|Reported Event|Conventional Mechanical Ventilation Period|"This is a crossover study. Infants were randomly assigned to one of two sequences that consisted of a 24-hour period during which the infant received conventional mechanical ventilation and another 24 hour period during which the infant received volume guarantee ventilation.~These data represent the 24 hours of Conventional Mechanical Ventilation."
722645|NCT01727258|B4|Baseline|Total|Total of all reporting groups
722646|NCT01727258|B3|Baseline|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
722647|NCT01727258|B2|Baseline|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
722648|NCT01727258|B1|Baseline|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
722655|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
722656|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
722657|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
722658|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
722659|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
722660|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
722661|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
722662|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
722663|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
722664|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
722665|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
722666|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
722667|NCT01727258|O3|Outcome|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033)
722668|NCT01727258|O2|Outcome|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046)
722669|NCT01727258|O1|Outcome|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007)
722670|NCT01727258|E3|Reported Event|Potassium Oxalate Mouthrinse|Potassium Oxalate Mouthrinse (experimental group)(12027-033).
722671|NCT01727258|E2|Reported Event|Sensodyne Toothpaste|5% Potassium Nitrate Dentifrice (Positive Control) (UPC #310158077046).
722672|NCT01727258|E1|Reported Event|Colgate Regular|Standard Sodium Fluoride Dentifrice (Negative Control) (UPC #035000513007).
722673|NCT01727180|B1|Baseline|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
722674|NCT01727180|P1|Participant Flow|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
722675|NCT01727180|O1|Outcome|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
722676|NCT01727180|E1|Reported Event|Chronic Kidney Disease|Questionnaire based on the McGill Pain Questionnaire: Interview questionnaire based on the short form of the McGill Pain Questionnaire
722677|NCT01727167|B3|Baseline|Total|Total of all reporting groups
722678|NCT01727167|B2|Baseline|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
722679|NCT01727167|B1|Baseline|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
722680|NCT01727167|P2|Participant Flow|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
722681|NCT01727167|P1|Participant Flow|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
722682|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
722683|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
722684|NCT01727167|O2|Outcome|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
722685|NCT01727167|O1|Outcome|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
722686|NCT01727167|E2|Reported Event|CO Group|"This group will breath 200 ppm of CO for one hour per day over the course of the three days immediately prior to surgery.~200ppm CO for one hour: This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery."
722687|NCT01727167|E1|Reported Event|Control Group|"This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.~Control: This group will breath room air for one hour per day over the course of the three days immediately prior to surgery."
722688|NCT01727141|B5|Baseline|Total|Total of all reporting groups
722689|NCT01727141|B4|Baseline|Placebo|b.i.d
722690|NCT01727141|B3|Baseline|NVA237|12.5 ug b.i.d.
722691|NCT01727141|B2|Baseline|QAB149|27.5 ug b.i.d.
722692|NCT01727141|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722693|NCT01727141|P4|Participant Flow|Placebo|b.i.d
722694|NCT01727141|P3|Participant Flow|NVA237|12.5 ug b.i.d.
722695|NCT01727141|P2|Participant Flow|QAB149|27.5 ug b.i.d.
722696|NCT01727141|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722700|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722704|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722705|NCT01727141|O4|Outcome|Placebo|b.i.d
722706|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722707|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722708|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722709|NCT01727141|O4|Outcome|Placebo|b.i.d
722710|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722711|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722712|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722713|NCT01727141|O4|Outcome|Placebo|b.i.d
722714|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722715|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722716|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722717|NCT01727141|O4|Outcome|Placebo|b.i.d
722718|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722719|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722720|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722721|NCT01727141|O4|Outcome|Placebo|b.i.d
722722|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722723|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722724|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722725|NCT01727141|O4|Outcome|Placebo|b.i.d
722726|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722727|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722728|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722729|NCT01727141|O4|Outcome|Placebo|b.i.d
722730|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722731|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722732|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722733|NCT01727141|O4|Outcome|Placebo|b.i.d
722734|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722735|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722736|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722737|NCT01727141|O4|Outcome|Placebo|b.i.d
722738|NCT01727141|O3|Outcome|NVA237|12.5 ug b.i.d.
722739|NCT01727141|O2|Outcome|QAB149|27.5 ug b.i.d.
722740|NCT01727141|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722741|NCT01727141|E4|Reported Event|Placebo|b.i.d
722742|NCT01727141|E3|Reported Event|NVA237|12.5 ug b.i.d.
722743|NCT01727141|E2|Reported Event|QAB149|27.5 ug b.i.d.
722744|NCT01727141|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d) via Single Dose Dry Powder Inhaler (SDDPI)
722745|NCT01727024|B1|Baseline|All Randomized Participants|All participants who were randomized either to sequence 1 or sequence 2
722746|NCT01727024|P2|Participant Flow|Tiotropium Respimat® First, Then Indacaterol Breezhaler®|In period 1, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days, followed by a 7-day washout. In period 2, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
722747|NCT01727024|P1|Participant Flow|Indacaterol Breezhaler® First, Then Tiotropium Respimat®|In period 1, participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days, followed by a 7-day washout. In period 2, participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
722748|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
722749|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
722750|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
722751|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
722752|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
722753|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
722754|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
722755|NCT01727024|O2|Outcome|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
722756|NCT01727024|O1|Outcome|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
722757|NCT01727024|E2|Reported Event|Tiotropium Respimat®|Participants received Tiotropium 2.5 mcg, in 2 consecutive puffs, once daily via Respimat® device for 7 days.
722758|NCT01727024|E1|Reported Event|Indacaterol (QAB149) Breezhaler®|Participants received Indacaterol 150 mcg once daily via Breezhaler® device for 7 days.
722759|NCT01726621|B1|Baseline|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
722760|NCT01726621|P1|Participant Flow|Insulin Dependent Diabetics|Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter
722761|NCT01726621|O1|Outcome|Insulin Depedent Diabetics|Subject is current insulin pump user and has CGM experience as determined by the investigator.
722797|NCT01726517|E2|Reported Event|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
722798|NCT01726517|E1|Reported Event|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
722799|NCT01726504|B3|Baseline|Total|Total of all reporting groups
722762|NCT01726621|E1|Reported Event|Insulin Dependent Diabetics|"Subjects currently using an insulin pump transferred to use the Medtronic MiniMed 620G and 640G insulin pumps and Guardian Link transmitter~Medtronic MiniMed 620G or 640G Insulin Pump: Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks."
722763|NCT01726517|B6|Baseline|Total|Total of all reporting groups
722764|NCT01726517|B5|Baseline|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
722765|NCT01726517|B4|Baseline|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722766|NCT01726517|B3|Baseline|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722767|NCT01726517|B2|Baseline|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
722768|NCT01726517|B1|Baseline|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
722769|NCT01726517|P5|Participant Flow|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
722770|NCT01726517|P4|Participant Flow|LDV/SOF 12 Weeks (TE)|Treatment-experienced (TE) participants (had virologic failure following prior therapy with a protease-inhibitor [PI]+pegylated interferon [PEG]+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722771|NCT01726517|P3|Participant Flow|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722772|NCT01726517|P2|Participant Flow|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based ribavirin (RBV) (1000-1200 mg) for 8 weeks.
722773|NCT01726517|P1|Participant Flow|LDV/SOF 8 Weeks (TN)|Treatment-naive (TN) participants were randomized to receive ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg for 8 weeks.
722774|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
722775|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722776|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722777|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
722778|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
722779|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
722780|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722781|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722782|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
722783|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
722784|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
722785|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722786|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722787|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
722788|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
722789|NCT01726517|O5|Outcome|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
722790|NCT01726517|O4|Outcome|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722791|NCT01726517|O3|Outcome|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722792|NCT01726517|O2|Outcome|LDV/SOF+RBV 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 8 weeks.
722793|NCT01726517|O1|Outcome|LDV/SOF 8 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 8 weeks.
722794|NCT01726517|E5|Reported Event|LDV/SOF+RBV 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg plus weight-based RBV (1000-1200 mg) for 12 weeks.
722795|NCT01726517|E4|Reported Event|LDV/SOF 12 Weeks (TE)|Treatment-experienced participants (had virologic failure following prior therapy with a PI+PEG+RBV regimen) were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722796|NCT01726517|E3|Reported Event|LDV/SOF 12 Weeks (TN)|Treatment-naive participants were randomized to receive LDV 90 mg/SOF 400 mg for 12 weeks.
722800|NCT01726504|B2|Baseline|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
722801|NCT01726504|B1|Baseline|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
722802|NCT01726504|P2|Participant Flow|Sham Electro-acupuncture|The acupuncture points are sham ST25, SP14, ST37. Sham location points are: about 2cm away from ST25,in the middle of the spleen and stomach channel; about 3 cm from SP14, in the middle of the spleen and stomach channel; one point beside ST37, in the middle of the stomach and gallbladder channel. The needle is inserted after sterilizing the skin by 1 to 1.5 cm, until the needle can be vertically fixed on the skin. No twirling lifting and thrusting manipulation is used. The sham electric stimulator (sham SDZ-V EA apparatus; Huatuo) is applied to the bilateral sham ST25 and sham SP14 with a dilatational wave of 10/50 Hz and electric current of 0.5 mA. The metal wire has been cut off inside to give the appearance of the real electric stimulator, with no current output. Length of treatment and the treatment sessions are the same as the treatment group sessions are the same as the treatment group.
722803|NCT01726504|P1|Participant Flow|Electro-acupuncture|"The acupuncture points are ST25, SP14,ST37. After sterilizing the skin, filiform needles are inserted 3 to 8 cm into bilateral ST25 and SP14 vertically and slowly without any manipulation until arrive the abdominal muscle layer(patients feel painful and acupuncturists feel touching hard). An electric stimulator (SDZ-V EA apparatus; Huatuo, China) is applied to bilateral ST25 and SP14 with a dilatational wave of 10/50 Hz and electric current between 0.1 and 1.0 mA with abdominal muscle twitching mildly indicating the appropriate dose.~The bilateral ST37 is inserted 3cm - twirling, lifting and thrusting three times. A local sour and heavy feeling indicates the appropriate dose.~Every session lasts for 30min/day. The participants are treated continuously for 8 weeks. During 8-week treatment the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total."
722804|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722805|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722806|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722830|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722871|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722873|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722807|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722808|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722809|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722810|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722811|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722812|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722813|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722831|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722832|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722814|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722815|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722816|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722817|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722818|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722819|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722820|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722833|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722834|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722821|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722822|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722823|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722824|NCT01726504|O2|Outcome|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722825|NCT01726504|O1|Outcome|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722826|NCT01726504|E2|Reported Event|Sham Electro-acupuncture|Sham Electroacupuncture (SA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks (five sessions in each of the first 2 weeks, followed by 3 sessions per week in the remaining 6 weeks). Huatuo disposable needles and EA apparatus, type SDZ-V (Suzhou Medical Appliance, China) were used. Participants in SA group received needling at bilateral non-acupoints of sham ST25, sham SP14, sham ST37. Specifically, 0.30 mm × 25 mm needles were used to penetrate the skin vertically at approximately 3 to 5 mm without any manipulation. Similar to EA group, paired alligator clips from the specially constructed EA apparatus were attached to the needle holders. When switched on, the EA apparatus in the SA group had the same working power indicator and sound but no actual current output. Additionally, 0.30 mm × 25 mm needles were inserted into sham ST37 vertically at about 3 - 5 mm without manipulation.
722827|NCT01726504|E1|Reported Event|Electro-acupuncture|Electroacupuncture (EA) group consisted of 28 sessions of 30 minutes’ duration, each administered over a period of 8 weeks. Huatuo disposable needles and EA apparatus, type SDZ-V(Suzhou Medical Appliance, China) were used. Participants in the EA group received EA at bilateral acupoints of ST25, SP14,ST37. With participant supine, 0.30 mm×50 mm or 0.35mm×75mm needles were inserted into ST25 and SP14 slowly and vertically, without manipulation, for approximately 30 to 70mm until they pierced the muscle layer of the abdominal wall. EA apparatus were attached transversely to bilateral ST25 and SP14, lasted for 30 minutes with a dilatational wave of 10/50Hz and current intensity of 0.1 to 1 mA depending on participant's comfort level. 0.30mm × 40mm needles were inserted into ST37 vertically for about 30mm and three small, equal manipulations of twirling, lifting, and thrusting were performed to reach acupuncture de qi.
722828|NCT01726335|B1|Baseline|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722829|NCT01726335|P1|Participant Flow|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722835|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722836|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722837|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722838|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722839|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722840|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722841|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722842|NCT01726335|O1|Outcome|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722843|NCT01726335|E1|Reported Event|Risperidone Prolonged Release|Risperidone was administered as an intramuscular injection (injection of a substance into a muscle) at a dose of 25 milligram (mg), every two weeks, from Week 1 to 50, wherein after Week 3, dose was adjusted up to 50 mg at Physician criterion. For first two weeks, previous oral antipsychotic drug was maintained and the dose was gradually decreased and ceased at Week 3.
722844|NCT01726049|B3|Baseline|Total|Total of all reporting groups
722845|NCT01726049|B2|Baseline|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
722846|NCT01726049|B1|Baseline|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
722847|NCT01726049|P2|Participant Flow|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
722848|NCT01726049|P1|Participant Flow|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
722849|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
722850|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
722851|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
722852|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
722853|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
722854|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
722855|NCT01726049|O2|Outcome|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
722856|NCT01726049|O1|Outcome|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
722857|NCT01726049|E2|Reported Event|Placebo|Placebo: Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
722858|NCT01726049|E1|Reported Event|Sildenafil|Sildenafil: Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
722859|NCT01726023|B3|Baseline|Total|Total of all reporting groups
722860|NCT01726023|B2|Baseline|Meropenem|Meropenem powder for solution for infusion 1000mg
722861|NCT01726023|B1|Baseline|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722862|NCT01726023|P2|Participant Flow|Meropenem|Meropenem powder for solution for infusion 1000mg
722863|NCT01726023|P1|Participant Flow|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722864|NCT01726023|O6|Outcome|Avibactam(3)|300-360 minutes after
722865|NCT01726023|O5|Outcome|Ceftazidime(3)|300-360 minutes after
722866|NCT01726023|O4|Outcome|Avibactam(2)|30-90 minutes after
722867|NCT01726023|O3|Outcome|Ceftazidime(2)|30-90 minutes after
722875|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722876|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722877|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722878|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722879|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722880|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722881|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722882|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722883|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722884|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722885|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722886|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722887|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722888|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722889|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722890|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722891|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722892|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722893|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722894|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722895|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722896|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722897|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722898|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722899|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722900|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722901|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722902|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722903|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722904|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722905|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722906|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722907|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion (summary only shows pathogens where N>/=10)
722908|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722909|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722910|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722911|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722912|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722913|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722914|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722915|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722917|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722918|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722919|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722920|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722921|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722922|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722923|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722924|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722925|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722926|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722927|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722928|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722929|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722930|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722931|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722932|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722933|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722934|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722935|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722936|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722937|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722938|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722939|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722940|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722941|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722942|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722943|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722944|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722945|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722946|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722947|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722948|NCT01726023|O2|Outcome|Meropenem|Meropenem powder for solution for infusion 1000mg
722949|NCT01726023|O1|Outcome|Ceftazidime-Avibactam Plus Metronidazole|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg Plus Metronidazole 500mg/100ml solution for infusion
722950|NCT01726023|E2|Reported Event|Meropenem|Meropenem powder for solution for infusion 1000mg
722951|NCT01726023|E1|Reported Event|CAZ-AVI Plus Metronidazole|
722952|NCT01725984|B3|Baseline|Total|Total of all reporting groups
722953|NCT01725984|B2|Baseline|AdVance XP|Subjects previously implanted with the AdVance XP male sling
722954|NCT01725984|B1|Baseline|AdVance|Subjects previously implanted with the AdVance Male Sling
722955|NCT01725984|P2|Participant Flow|AdVance XP|Subjects previously implanted with the AdVance XP male sling
722956|NCT01725984|P1|Participant Flow|AdVance|Subjects previously implanted with the AdVance Male Sling
722957|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
722958|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
722959|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
722960|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
722961|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
722962|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
722963|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
722964|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
722965|NCT01725984|O2|Outcome|AdVance XP|Subjects previously implanted with the AdVance XP male sling
722966|NCT01725984|O1|Outcome|AdVance|Subjects previously implanted with the AdVance Male Sling
723015|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
724188|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
722980|NCT01725529|B3|Baseline|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722981|NCT01725529|B2|Baseline|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722982|NCT01725529|B1|Baseline|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
722983|NCT01725529|P3|Participant Flow|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722984|NCT01725529|P2|Participant Flow|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722985|NCT01725529|P1|Participant Flow|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
722986|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722987|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722988|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
722989|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722990|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722991|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
722992|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722993|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722994|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
722995|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722996|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722997|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
722998|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
722999|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
723000|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
723001|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
723002|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
723003|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
723004|NCT01725529|O3|Outcome|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
723005|NCT01725529|O2|Outcome|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
723006|NCT01725529|O1|Outcome|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
723007|NCT01725529|E3|Reported Event|Simeprevir (TMC435) 150mg|Participants received TMC435 150 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 100 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
723008|NCT01725529|E2|Reported Event|Simeprevir (TMC435) 100mg|Participants received TMC435 100 mg once daily (q.d.) for 12 weeks plus peginterferon-alpha (PegIFNα-2a), ribavirin (RBV) and Placebo matching to TMC435 150 mg, followed by PegIFNα-2a and RBV alone. Response-guided treatment criterion was used to determine total treatment duration of 24 or 48 weeks for participants in the TMC435 treatment groups.
723009|NCT01725529|E1|Reported Event|Placebo|Participants received placebo matching to TMC435 100 milligram (mg) and TMC435 150 mg for 12 weeks once daily (q.d.) plus peginterferon-alpha (PegIFNa-2a) and ribavirin (RBV) for 48 weeks.
723010|NCT01725451|B1|Baseline|Testosterone 2% Solution|Participants randomized to 1 of 4 treatment sequences involving 6 treatments in each sequence. Each sequence involved 4 single-dose treatments of testosterone 2% solution to unshaved axillae with or without the use of deodorant or antiperspirant products followed by 2 single-dose treatments of testosterone 2% solution to shaved axillae with or without the use of deodorant or antiperspirant products. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
723011|NCT01725451|P4|Participant Flow|Sequence 4|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
723012|NCT01725451|P3|Participant Flow|Sequence 3|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
723013|NCT01725451|P2|Participant Flow|Sequence 2|30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 5, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
723014|NCT01725451|P1|Participant Flow|Sequence 1|30-milligram (mg) testosterone 2% solution applied to each unshaved axilla without deodorant or antiperspirant in Period 1, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination stick in Period 2, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant spray in Period 3, 30-mg testosterone 2% solution applied to each unshaved axilla with deodorant/antiperspirant combination spray in Period 4, 30-mg testosterone 2% solution applied to each shaved axilla without deodorant or antiperspirant in Period 5, and 30-mg testosterone 2% solution applied to each shaved axilla with deodorant/antiperspirant combination spray in Period 6. Each of the treatments was followed by 3 days of pharmacokinetic (PK) sampling and 1-day washout except that there was no washout after the last PK sample for the last treatment.
723054|NCT01725308|B2|Baseline|Treatment Period I: FK949E 150 mg|Participants who received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723016|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
723017|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723018|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution .
723019|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723020|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
723021|NCT01725451|O6|Outcome|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723022|NCT01725451|O5|Outcome|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
723023|NCT01725451|O4|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723024|NCT01725451|O3|Outcome|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723025|NCT01725451|O2|Outcome|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723026|NCT01725451|O1|Outcome|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
723027|NCT01725451|E6|Reported Event|Testosterone Shaved + Deodorant Antiperspirant Spray|Deodorant/antiperspirant combination spray applied to each shaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723028|NCT01725451|E5|Reported Event|Testosterone Shaved|No deodorant or antiperspirant. A single 30-mg dose of testosterone 2% solution applied topically to each shaved axilla.
723029|NCT01725451|E4|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Stick|Deodorant/antiperspirant combination stick applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723030|NCT01725451|E3|Reported Event|Testosterone Unshaved + Deodorant Antiperspirant Spray|Deodorant antiperspirant combination spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723031|NCT01725451|E2|Reported Event|Testosterone Unshaved + Deodorant Spray|Deodorant spray applied to each unshaved axilla ≥2 minutes before application of a single 30-mg dose of testosterone 2% solution.
723032|NCT01725451|E1|Reported Event|Testosterone Unshaved|No deodorant or antiperspirant. A single 30-milligram (mg) dose of testosterone 2% solution applied topically to each unshaved axilla.
723033|NCT01725386|B3|Baseline|Total|Total of all reporting groups
723034|NCT01725386|B2|Baseline|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723035|NCT01725386|B1|Baseline|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723036|NCT01725386|P2|Participant Flow|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723037|NCT01725386|P1|Participant Flow|Monotherapy|Capecitabine (XELODA®) as monotherapy according to prescribing information and normal clinical practice.
723038|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723039|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723040|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723041|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723042|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723043|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723044|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723045|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723046|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723047|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723048|NCT01725386|O2|Outcome|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723049|NCT01725386|O1|Outcome|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723050|NCT01725386|E2|Reported Event|Combination Therapy|Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
723051|NCT01725386|E1|Reported Event|Monotherapy|Capecitabine as monotherapy according to prescribing information and normal clinical practice.
723052|NCT01725308|B4|Baseline|Total|Total of all reporting groups
723053|NCT01725308|B3|Baseline|Treatment Period I: FK949E 300 mg|Participants who received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723055|NCT01725308|B1|Baseline|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723134|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723056|NCT01725308|P3|Participant Flow|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723057|NCT01725308|P2|Participant Flow|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723058|NCT01725308|P1|Participant Flow|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723059|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723060|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723061|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723062|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723063|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723064|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723065|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723066|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723067|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723068|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723069|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723070|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723071|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723072|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723073|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723074|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723075|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723076|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723077|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723078|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723079|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723080|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723081|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723082|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723083|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723084|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723085|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723086|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723087|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723088|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723089|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723090|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723091|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723092|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723093|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723094|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723095|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723096|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723097|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723098|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723099|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723100|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723101|NCT01725308|O3|Outcome|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723102|NCT01725308|O2|Outcome|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723103|NCT01725308|O1|Outcome|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723104|NCT01725308|E3|Reported Event|Treatment Period I: FK949E 300 mg|After 4 days of up-titration, participants received FK949E 300 mg once daily at bedtime for 8 weeks in Treatment Period I.
723105|NCT01725308|E2|Reported Event|Treatment Period I: FK949E 150 mg|After 2 days of up-titration, participants received FK949E 150 mg once daily at bedtime for 8 weeks in Treatment Period I.
723106|NCT01725308|E1|Reported Event|Treatment Period I: Placebo|Participants who received placebo once daily at bedtime for 8 weeks in Treatment Period I.
723107|NCT01725282|B5|Baseline|Total|Total of all reporting groups
723108|NCT01725282|B4|Baseline|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723109|NCT01725282|B3|Baseline|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723110|NCT01725282|B2|Baseline|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723111|NCT01725282|B1|Baseline|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723112|NCT01725282|P4|Participant Flow|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723113|NCT01725282|P3|Participant Flow|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723114|NCT01725282|P2|Participant Flow|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723115|NCT01725282|P1|Participant Flow|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723116|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723117|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723118|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723119|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723120|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723121|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723122|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723123|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723124|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723125|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723126|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723127|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723128|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723129|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723130|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723131|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723132|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723133|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723135|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723136|NCT01725282|O4|Outcome|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723137|NCT01725282|O3|Outcome|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723138|NCT01725282|O2|Outcome|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723139|NCT01725282|O1|Outcome|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723140|NCT01725282|E4|Reported Event|Quetiapine 300 mg|After 4 days of up-titration, participants received quetiapine XR 300 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 150 mg tablets once daily for 1 week.
723141|NCT01725282|E3|Reported Event|Quetiapine 150 mg|After 2 days of up-titration, participants received quetiapine XR 150 mg tablets once daily before bedtime for 6 weeks followed by quetiapine XR 50 mg tablets once daily for 1 week.
723142|NCT01725282|E2|Reported Event|Quetiapine 50 mg|Participants received quetiapine extended release (XR) 50 mg tablets once daily before bedtime for 7 weeks.
723143|NCT01725282|E1|Reported Event|Placebo|Participants received matching placebo tablets once daily before bedtime for 7 weeks.
723144|NCT01725217|B4|Baseline|Total|Total of all reporting groups
723145|NCT01725217|B3|Baseline|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723146|NCT01725217|B2|Baseline|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723147|NCT01725217|B1|Baseline|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
723148|NCT01725217|P3|Participant Flow|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723149|NCT01725217|P2|Participant Flow|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723150|NCT01725217|P1|Participant Flow|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
723151|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723152|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723153|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
723154|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
723155|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723156|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723157|NCT01725217|O2|Outcome|≥6 to ≤10 Years|Subjects ≥6 to ≤10 years of age who received one vaccination of MenACWY-CRM
723158|NCT01725217|O1|Outcome|Overall (≥6 Years)|All subjects ≥6 years of age who received one vaccination of MenACWY-CRM
723159|NCT01725217|O2|Outcome|≥2 to ≤3 Years|Subjects ≥2 to ≤3 years of age who received one vaccination of MenACWY-CRM
723160|NCT01725217|O1|Outcome|≥2 to ≤5 Years|Subjects ≥2 to ≤5 years of age who received one vaccination of MenACWY-CRM
723161|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723162|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723163|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
723164|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
723165|NCT01725217|O4|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723166|NCT01725217|O3|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723167|NCT01725217|O2|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
723168|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
723169|NCT01725217|O3|Outcome|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723170|NCT01725217|O2|Outcome|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723171|NCT01725217|O1|Outcome|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
723172|NCT01725217|O1|Outcome|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
723173|NCT01725217|E4|Reported Event|Overall (≥2 Years)|All subjects ≥2 years of age who received one vaccination of MenACWY-CRM
723174|NCT01725217|E3|Reported Event|≥18 Years|Subjects ≥18 years of age who received one vaccination of MenACWY-CRM
723175|NCT01725217|E2|Reported Event|≥11 to ≤17 Years|Subjects ≥11 to ≤17 years of age who received one vaccination of MenACWY-CRM
723176|NCT01725217|E1|Reported Event|≥2 to ≤10 Years|Subjects ≥2 to ≤10 years of age who received one vaccination of MenACWY-CRM
723177|NCT01724528|B3|Baseline|Total|Total of all reporting groups
723178|NCT01724528|B2|Baseline|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723179|NCT01724528|B1|Baseline|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
724166|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
723180|NCT01724528|P2|Participant Flow|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723497|NCT01722071|B1|Baseline|Participants|Each participant will complete baseline assessments prior to being studied using fMRI
723181|NCT01724528|P1|Participant Flow|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
723182|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723183|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
723184|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723185|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
723186|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723187|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
723188|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723189|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
723190|NCT01724528|O2|Outcome|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723191|NCT01724528|O1|Outcome|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
723192|NCT01724528|E2|Reported Event|Allopurinol|"Allopurinol for 7-9 days~Allopurinol: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)"
723193|NCT01724528|E1|Reported Event|Febuxostat|"Febuxostat for 7-9 days~Febuxostat: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)"
723194|NCT01724359|B1|Baseline|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723195|NCT01724359|P1|Participant Flow|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723196|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723197|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723198|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723199|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723200|NCT01724359|O2|Outcome|Patients at Week 26: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723201|NCT01724359|O1|Outcome|Patients at Baseline: Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723202|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723203|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723204|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723205|NCT01724359|O1|Outcome|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723206|NCT01724359|E1|Reported Event|Paliperidone Extended-release (ER)|The recommended Paliperidone ER dose is 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily.
723207|NCT01724216|B1|Baseline|Single Arm|Magnetic Resonance Image Collection Using Innovative Pulse Sequences
723208|NCT01724216|P1|Participant Flow|Single Arm|Magnetic Resonance Images Collected Using Innovative Pulse Sequences :
723209|NCT01724216|O1|Outcome|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
723210|NCT01724216|E1|Reported Event|Single Arm|Magnetic Resonance Imaging Using Innovative Pulse Sequences :
724167|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
723211|NCT01724177|B1|Baseline|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity.
724189|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
723212|NCT01724177|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
723213|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
723214|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
723215|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
723216|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered by mouth (PO) once daily (QD) until progressive disease or unacceptable toxicity
723217|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
723218|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
723219|NCT01724177|O1|Outcome|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
723220|NCT01724177|E1|Reported Event|Lenalidomide|Lenalidomide 25 mg administered orally once daily (QD) until progressive disease or unacceptable toxicity
723221|NCT01724021|B3|Baseline|Total|Total of all reporting groups
723222|NCT01724021|B2|Baseline|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723223|NCT01724021|B1|Baseline|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723224|NCT01724021|P2|Participant Flow|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723225|NCT01724021|P1|Participant Flow|Arm A|Participants in Arm A received one cycle of rituximab 375 milligram per metre square (mg/m^2) intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723226|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723227|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723228|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723229|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723230|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723231|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723374|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723232|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723233|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723234|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723235|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723236|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723237|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723238|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723239|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723240|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723241|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723242|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723243|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723244|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723274|NCT01723722|E1|Reported Event|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
723275|NCT01723397|B3|Baseline|Total|Total of all reporting groups
723570|NCT01721564|E1|Reported Event|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
723245|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723246|NCT01724021|O2|Outcome|Rituximab Subcutaneous (SC)|Each treatment cycle consisted of a single SC injection of rituximab administered at a fixed dose of 1400 mg. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723247|NCT01724021|O1|Outcome|Rituximab Intravenous (IV)|Rituximab was administered at a dose of 375 mg/m2 body surface area (BSA) as a single IV infusion, followed by administration of chemotherapy. At Cycle 1, Day 1, the first rituximab dose for both Arms A and B was always administered as a slow IV infusion, according to local standard practice. Faster infusion rates were permitted after Cycle 1, according to local practice. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723248|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723249|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723250|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723251|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723252|NCT01724021|O2|Outcome|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723253|NCT01724021|O1|Outcome|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723254|NCT01724021|E2|Reported Event|Arm B|Participants in Arm B received four cycles of rituximab 375 mg/m^2 IV followed by four cycles of rituximab 1400mg SC in combination with a standard chemotherapy of CHOP, CVP, or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723255|NCT01724021|E1|Reported Event|Arm A|Participants in Arm A received one cycle of rituximab 375 mg/m^2 intravenously (IV), then three cycles of rituximab 1400mg subcutaneously (SC), followed by four cycles of rituximab 375 mg/m^2 IV in combination with a standard chemotherapy of cyclophosphamide, hydroxydaunorubicin, Oncovin, prednisone/prednisolone (CHOP), cyclophosphamide, vincristine, prednisone/prednisolone (CVP), or bendamustine. Rituximab was administered on Day 1 of each treatment cycle followed by administration of the preselected chemotherapy. Cycles were repeated every 14, 21, or 28 days, depending on the combination chemotherapy regimen selected by the investigator.
723256|NCT01723904|B1|Baseline|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723257|NCT01723904|P1|Participant Flow|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723571|NCT01721486|B3|Baseline|Total|Total of all reporting groups
723258|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723259|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723260|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723261|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723262|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723263|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723264|NCT01723904|O1|Outcome|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723265|NCT01723904|E1|Reported Event|Rotigotine|"- Titration Period: Weekly titration to the subject's optimal dose of Rotigotine between 2 mg/24 h and 8 mg/24 h. In case of intolerable Adverse Events (AEs) one back-titration is allowed during the Titration Period.~Duration of the Titration Period: Between 1 week and 5 weeks.~- Maintenance Period: Starts once subject reached either optimal or maximal dose of Rotigotine. Subjects receive stable dose of Rotigotine throughout the Maintenance Period. No back-titration is allowed during the Maintenance Period.~Duration of the Maintenance Period: Between 3 weeks and 7 weeks.~Rotigotine: Application of Rotigotine up to 8 mg/24 h patches for 24 hours."
723266|NCT01723722|B3|Baseline|Total|Total of all reporting groups
723267|NCT01723722|B2|Baseline|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
723268|NCT01723722|B1|Baseline|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
723269|NCT01723722|P2|Participant Flow|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
723270|NCT01723722|P1|Participant Flow|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
723271|NCT01723722|O2|Outcome|Methadone After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started methadone
723272|NCT01723722|O1|Outcome|Deodorized Tincture Opium After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
723273|NCT01723722|E2|Reported Event|DTO After Phenobarbital for Withdrawal|for withdrawal reaching treatment threshold phenobarbital was first started and if a second drug was needed randomization was done after consent; this arm started dilute deordorized tincture of opium
723276|NCT01723397|B2|Baseline|Placebo Spray, Then Nasaleze Spray|"This group first received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
723277|NCT01723397|B1|Baseline|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
723278|NCT01723397|P2|Participant Flow|Placebo Spray, Then Nasaleze Spray|"This group first received Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (grass or ragweed) challenge, followed by a 1 week washout and then received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
723279|NCT01723397|P1|Participant Flow|Nasaleze Spray, Then Placebo Spray|"This group first received Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen (either grass or ragweed) challenge, then after a 1 week washout received placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge"
723280|NCT01723397|O2|Outcome|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
723281|NCT01723397|O1|Outcome|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
723282|NCT01723397|E2|Reported Event|Placebo Spray|"Placebo spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Placebo spray: Subjects are treated with placebo nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
723283|NCT01723397|E1|Reported Event|Nasaleze Spray|"Nasaleze spray 1 puff via spray device in each nostril 3 times daily for 1 week followed by allergen challenge~Nasaleze Spray: Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen~Allergen: Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo"
723284|NCT01723254|B9|Baseline|Total|Total of all reporting groups
723285|NCT01723254|B8|Baseline|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
723286|NCT01723254|B7|Baseline|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723287|NCT01723254|B6|Baseline|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723288|NCT01723254|B5|Baseline|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723289|NCT01723254|B4|Baseline|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723290|NCT01723254|B3|Baseline|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723291|NCT01723254|B2|Baseline|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723292|NCT01723254|B1|Baseline|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723293|NCT01723254|P8|Participant Flow|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
724168|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
723294|NCT01723254|P7|Participant Flow|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723295|NCT01723254|P6|Participant Flow|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723296|NCT01723254|P5|Participant Flow|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723297|NCT01723254|P4|Participant Flow|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723298|NCT01723254|P3|Participant Flow|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723299|NCT01723254|P2|Participant Flow|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723300|NCT01723254|P1|Participant Flow|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723301|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
723302|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723303|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723304|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723305|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723306|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723307|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723308|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723309|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
723310|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723311|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723312|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723313|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723314|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723315|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723316|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723317|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
723318|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723319|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723320|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723321|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723322|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723323|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723324|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723325|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
723326|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723327|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723328|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723329|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723330|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723331|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723332|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723333|NCT01723254|O8|Outcome|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
723334|NCT01723254|O7|Outcome|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723335|NCT01723254|O6|Outcome|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723336|NCT01723254|O5|Outcome|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723337|NCT01723254|O4|Outcome|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723338|NCT01723254|O3|Outcome|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723339|NCT01723254|O2|Outcome|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723340|NCT01723254|O1|Outcome|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 mcg on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a TLR9 agonist) in combination as adjuvants.
723341|NCT01723254|E8|Reported Event|Saline Placebo|Participants received saline placebo matching IGE-1 or IGE-2 on Days 1, 28, 56, and 168. Placebo was also administered intramuscularly in the upper deltoid muscle on the participant's preferred side.
723342|NCT01723254|E7|Reported Event|IGE-2 200 mcg|Participants received study vaccine IGE-2 (PF-06444752) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723343|NCT01723254|E6|Reported Event|IGE-2 60 mcg|Participants received study vaccine IGE-2 (PF-06444752) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723344|NCT01723254|E5|Reported Event|IGE-2 20 mcg|Participants received study vaccine IGE-2 (PF-06444752) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-2 and IGE-1 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723345|NCT01723254|E4|Reported Event|IGE-1 200 mcg|Participants received study vaccine IGE-1 (PF-06444753) 200 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723346|NCT01723254|E3|Reported Event|IGE-1 60 mcg|Participants received study vaccine IGE-1 (PF-06444753) 60 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723347|NCT01723254|E2|Reported Event|IGE-1 20 mcg|Participants received study vaccine IGE-1 (PF-06444753) 20 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723348|NCT01723254|E1|Reported Event|IGE-1 6 mcg|Participants received study vaccine IGE-1 (PF-06444753) 6 micrograms (mcg) on Days 1, 28, 56, and 168. Study vaccine volume was 0.5 mL and was administered intramuscularly in the upper deltoid muscle on the participant's preferred side. IGE-1 and IGE-2 contained the same antigenic material but differed in their fixed adjuvant configurations: IGE-1 was with aluminum hydroxide (alum) alone and IGE-2 with alum and CpG 24555 (CpG; a toll-like receptor 9 [TLR9] agonist) in combination as adjuvants.
723349|NCT01723228|B3|Baseline|Total|Total of all reporting groups
723350|NCT01723228|B2|Baseline|Placebo|Placebo oral tablets once daily for 24 weeks
723351|NCT01723228|B1|Baseline|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723352|NCT01723228|P2|Participant Flow|Placebo|Placebo oral tablets once daily for 24 weeks
723353|NCT01723228|P1|Participant Flow|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723354|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
723355|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723356|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
723357|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723358|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
723359|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723360|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
723361|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723362|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
723363|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723364|NCT01723228|O2|Outcome|Placebo|Placebo oral tablets once daily for 24 weeks
723365|NCT01723228|O1|Outcome|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723366|NCT01723228|E2|Reported Event|Placebo|Placebo oral tablets once daily for 24 weeks
723367|NCT01723228|E1|Reported Event|Rasagiline 1.0 mg/Day|Rasagiline 1 mg oral tablets once daily for 24 weeks
723368|NCT01722994|B3|Baseline|Total|Total of all reporting groups
723369|NCT01722994|B2|Baseline|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723370|NCT01722994|B1|Baseline|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723371|NCT01722994|P2|Participant Flow|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723372|NCT01722994|P1|Participant Flow|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723373|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723375|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723376|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723377|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723378|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723379|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound Using Polyglactin 910 Suture|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723380|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound Using Chromic Gut Suture|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723381|NCT01722994|O2|Outcome|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723382|NCT01722994|O1|Outcome|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723383|NCT01722994|E2|Reported Event|Group 2 Punch Biopsy Wound|"This is one of two absorbable sutures used to close punch biopsy wounds.~Polyglactin 910 sterile synthetic absorbable suture (Ethicon): Half of punch biopsy wounds are closed with each absorbablesuture"
723384|NCT01722994|E1|Reported Event|Group 1 Punch Biopsy Wound|"One of two absorbable sutures is used to close punch wounds.~Chromic Gut Sterile absorbable Suture (Ethicon)"
723385|NCT01722877|B1|Baseline|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery. Patients were eligible for the study only if they had a more or equal 50% in-stent restenotic lesion in the superficial femoral or popliteal arteries (estimated diameter ≥5 mm), Rutherford category 1-5 ischemia, and at least one patent infrapopliteal runoff vessel. Patients were excluded if they were not able to give informed consent, had a creatinine level >2.5 mg/dL, were unable to take antiplatelet drugs, or had a planned surgical or endovascular procedure within 15 days of the index procedure.The JetStream was used as a first modality of treatment, no other debulking devices, cutting/scoring balloons, or cryogenic balloons were allowed.
723386|NCT01722877|P1|Participant Flow|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
723387|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
723388|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
723389|NCT01722877|O1|Outcome|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
723390|NCT01722877|O1|Outcome|JetStream Atherectomy|"Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature.~JetStream Navitus: Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery."
723391|NCT01722877|E1|Reported Event|JetStream Atherectomy|Jetstream NAVITUS System is a rotating, aspirating, expandable catheter for active removal of atherosclerotic disease and thrombus in peripheral vasculature. In this study, Jetstream Navitus was used to treat in-stent restenosis in femoral popliteal artery.
723392|NCT01722734|B4|Baseline|Total|Total of all reporting groups
723393|NCT01722734|B3|Baseline|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
723394|NCT01722734|B2|Baseline|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
723395|NCT01722734|B1|Baseline|Control|Patients in this group received only a generic malaria information message (use bed nets) at the end of the study.
723396|NCT01722734|P3|Participant Flow|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
723397|NCT01722734|P2|Participant Flow|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
723398|NCT01722734|P1|Participant Flow|Control|Control group participants received only a message after five days informing them about the importance of using bed nets for malaria. No reminders to take ACTs were sent.
723399|NCT01722734|O3|Outcome|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
723400|NCT01722734|O2|Outcome|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
723401|NCT01722734|O1|Outcome|Control|Subjects in this group received only one generic malaria message (use bed nets) at the end of the study.
723402|NCT01722734|E3|Reported Event|Long Message|Patients in this arm receive six long text message reminders (reminders including justification for why patients should finish medication) within 60 hours of treatment initiation at 12 hour intervals.
723403|NCT01722734|E2|Reported Event|Short Message|Patients in this arm receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals.
723404|NCT01722734|E1|Reported Event|Control|Patients in this group received only a generic malaria message at the end of the study.
723405|NCT01722552|B1|Baseline|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
723406|NCT01722552|P1|Participant Flow|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
723407|NCT01722552|O2|Outcome|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
723408|NCT01722552|O1|Outcome|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
723409|NCT01722552|O2|Outcome|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
723410|NCT01722552|O1|Outcome|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
723411|NCT01722552|E2|Reported Event|Control|Control subjects will use the electronic monitoring devices just like the intervention arm, but will receive standard of care. They will not receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time, and they will not have access to the summaries of their previous month's behavior for use in interactive counseling sessions, though they will be encouraged to engage in counseling.
723412|NCT01722552|E1|Reported Event|Adherence Feedback|"Intervention subjects will receive personalized cell phone reminder messages whenever they fail to take a dose within 30 minutes of dose time (as indicated by lack of a Wisepill opening). They will then participate in monthly interactive counseling sessions using summaries of their previous month's behavior. Patients whose mean adherence in the previous month was <95% will be required to have a counseling session, while those with higher adherence will be given the option to have a counseling session.~adherence feedback"
723413|NCT01722487|B3|Baseline|Total|Total of all reporting groups
723414|NCT01722487|B2|Baseline|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723415|NCT01722487|B1|Baseline|Ibrutinib|Ibrutinib 420 mg daily.
723416|NCT01722487|P2|Participant Flow|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723417|NCT01722487|P1|Participant Flow|Ibrutinib|Ibrutinib 420 mg daily.
723418|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723419|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
723420|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723421|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
723422|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723423|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
723424|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723425|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
723426|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723427|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
723428|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723429|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
723430|NCT01722487|O2|Outcome|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles.
723431|NCT01722487|O1|Outcome|Ibrutinib|Ibrutinib 420 mg daily.
723432|NCT01722487|E2|Reported Event|Chlorambucil|Chlorambucil 0.5 mg/kg (to maximum 0.8 mg/kg) days 1 and 15 of 28-day cycle up to 12 cycles
723433|NCT01722487|E1|Reported Event|PCI-32765|Ibrutinib 420 mg daily.
723637|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723496|NCT01722097|E1|Reported Event|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
723434|NCT01722435|B1|Baseline|OST Completers|"The main objective of this prospective study was the description of the process of termination of opiate substitution treatment (OST). Patients in primary care setting (GPs) or specialized clinics likely to complete OST during the next 12 months were asked to fill out questionnaires every 3 months over a 12-months period and were followed up another 6 months later. Accordingly, the doctors documented their patients’ state of health and provided an evaluation of their living situation every 3 months and at the end of treatment (or – if patients stayed in treatment – at the end of the 18-months study period).~At the beginning of the study overall 1367 OST patients were treated in the 7 participating clinics and practices. 972 of them were treated with methadone or levomethadone. In line with the inclusion criteria, 97 patients were eligible for the study, 78 of them consented to participate in the study (8.0% of all patients treated with methadone or levomethadone)."
723435|NCT01722435|P1|Participant Flow|OST Completers|"Patients who are likely to complete OST during the next 12 or 18 months~Opiate Substitution Treatment"
723436|NCT01722435|O1|Outcome|Still in OST Completers|Patients still in OST during the whole study period.
723437|NCT01722435|O1|Outcome|OST Drop-outs|Patients dropped out of OST during 12 or 18 months.
723438|NCT01722435|O1|Outcome|OST Completers|Patients completed OST during 12 or 18 months.
723439|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months.
723440|NCT01722435|O1|Outcome|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
723441|NCT01722435|E1|Reported Event|OST Completers|Patients who are likely to complete OST during the next 12 or 18 months Opiate Substitution Treatment
723442|NCT01722266|B5|Baseline|Total|Total of all reporting groups
723443|NCT01722266|B4|Baseline|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723444|NCT01722266|B3|Baseline|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723445|NCT01722266|B2|Baseline|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723446|NCT01722266|B1|Baseline|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723447|NCT01722266|P4|Participant Flow|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723448|NCT01722266|P3|Participant Flow|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723449|NCT01722266|P2|Participant Flow|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723450|NCT01722266|P1|Participant Flow|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723451|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723452|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723453|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723494|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
723743|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723454|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723455|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723456|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723457|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723458|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723459|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723460|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723461|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723462|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723463|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723464|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723465|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723466|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723467|NCT01722266|O4|Outcome|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723468|NCT01722266|O3|Outcome|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723469|NCT01722266|O2|Outcome|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723495|NCT01722097|E2|Reported Event|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
723470|NCT01722266|O1|Outcome|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723471|NCT01722266|E4|Reported Event|Liraglutide 0.6 mg|"Daily injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723472|NCT01722266|E3|Reported Event|Liraglutide 1.2mg|"Daily injections~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723473|NCT01722266|E2|Reported Event|Liraglutide 1.8mg|"Daily Injection~Liraglutide: Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
723474|NCT01722266|E1|Reported Event|Placebo|"Daily Injection~Placebo: Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
723475|NCT01722162|B3|Baseline|Total|Total of all reporting groups
723476|NCT01722162|B2|Baseline|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
723477|NCT01722162|B1|Baseline|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
723478|NCT01722162|P2|Participant Flow|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
723479|NCT01722162|P1|Participant Flow|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
723480|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
723481|NCT01722162|O2|Outcome|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
723482|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
723483|NCT01722162|O1|Outcome|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
723484|NCT01722162|E2|Reported Event|Arm B: (Start Levocetirizine Before Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily starting 7 days prior to initiation of bevacizumab and capecitabine therapy. 5 mg daily Days 1-14 starting with cycle 2."
723485|NCT01722162|E1|Reported Event|Arm A: (Start Levocetirizine After Bevacizumab/Capecitabine)|"Bevacizumab IV 5 mg/kg on Days 1 each 2-week cycle.~Capecitabine PO 850 mg/m2 twice a day on Days 1-7 of each 2 week cycle.~Levocetirizine PO 5 mg daily before bed starting on Day 8 of Cycle 1. 5 mg daily before bed Days 1-4 of each cycle starting with cycle 2."
723486|NCT01722097|B3|Baseline|Total|Total of all reporting groups
723487|NCT01722097|B2|Baseline|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
723488|NCT01722097|B1|Baseline|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
723489|NCT01722097|P2|Participant Flow|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
723490|NCT01722097|P1|Participant Flow|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
723491|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
723492|NCT01722097|O1|Outcome|Deep Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h Other Name: Esmeron~Rocuronium"
723493|NCT01722097|O2|Outcome|Moderate Neuromuscular Blockade|"Drug: Rocuronium Intravenous use: 0,3 mg/kg followed by NaCl-infusion Other Name: Esmeron~placebo"
723498|NCT01722071|P2|Participant Flow|Oxytocin Then Placebo|"These participants were first studied using fMRI following self-administration of oxytocin (followed by another scanning session with placebo).~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
723499|NCT01722071|P1|Participant Flow|Placebo Then Oxytocin|"These participants were first studied using fMRI following self-administration of placebo (followed by another scanning session with oxytocin).~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
723500|NCT01722071|O2|Outcome|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
723501|NCT01722071|O1|Outcome|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
723502|NCT01722071|E2|Reported Event|Oxytocin Then Placebo|"Each participant will be studied using fMRI following self-administration of oxytocin.~Oxytocin: Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session."
723503|NCT01722071|E1|Reported Event|Placebo Then Oxytocin|"Each participant will be studied using fMRI following self-administration of placebo.~Placebo: Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session."
723504|NCT01721967|B1|Baseline|Ranolazine|Ranolazine, 500 mg for 60 days
723505|NCT01721967|P1|Participant Flow|Ranolazine|Ranolazine, 500 mg for 60 days
723506|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
723507|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
723508|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
723509|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
723510|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
723511|NCT01721967|O1|Outcome|Ranolazine|Ranolazine, 500 mg for 60 days
723512|NCT01721967|E1|Reported Event|Ranolazine|Ranolazine, 500 mg for 60 days
723513|NCT01721837|B1|Baseline|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
723514|NCT01721837|P1|Participant Flow|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (Per Protocol Set, PPS).
723515|NCT01721837|O1|Outcome|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
723516|NCT01721837|E1|Reported Event|All Patients|All patients with documented mild or moderate renal impairment and non valvular atrial fibrillation (PPS).
723517|NCT01721772|B3|Baseline|Total|Total of all reporting groups
723518|NCT01721772|B2|Baseline|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723519|NCT01721772|B1|Baseline|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723520|NCT01721772|P2|Participant Flow|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723521|NCT01721772|P1|Participant Flow|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723522|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723523|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723524|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723525|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723526|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723527|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723528|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
724190|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
723529|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723530|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723531|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723532|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723533|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723534|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723535|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723536|NCT01721772|O2|Outcome|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723537|NCT01721772|O1|Outcome|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723538|NCT01721772|E2|Reported Event|Dacarbazine, 1000 mg/m^2 + Placebo-matching Nivolumab|Participants received dacarbazine 1000 mg/m^2, solution administered IV every 3 weeks with placebo-matching nivolumab solution administered IV every 2 weeks until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723539|NCT01721772|E1|Reported Event|Nivolumab, 3 mg/kg + Placebo-matching Dacarbazine|Participants received nivolumab, 3 mg/kg, solution administered Intravenously (IV) every 2 weeks with placebo-matching dacarbazine solution administered IV every 3 weeks, until disease progression, discontinuation due to toxicity, withdrawal of consent, or study completion
723540|NCT01721759|B1|Baseline|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
723541|NCT01721759|P1|Participant Flow|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
723542|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
723543|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
723544|NCT01721759|O1|Outcome|Nivolumab, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
723545|NCT01721759|E1|Reported Event|NivolumAB, 3 mg/kg|Participants received nivolumab, 3 mg/kg, intravenously over 60 minutes every 2 weeks (on Day 1 of each cycle) until disease progression, discontinuation due to toxicity, withdrawal of consent, or end of study. Every 2-week treatment period was considered to be a cycle.
723546|NCT01721746|B3|Baseline|Total|Total of all reporting groups
723547|NCT01721746|B2|Baseline|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723548|NCT01721746|B1|Baseline|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723568|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
723569|NCT01721564|O1|Outcome|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
723572|NCT01721486|B2|Baseline|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
723549|NCT01721746|P3|Participant Flow|Investigator's Choice (Carboplatin+Paclitaxel)|"Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723550|NCT01721746|P2|Participant Flow|Investigator's Choice (Dacarbazine)|Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723551|NCT01721746|P1|Participant Flow|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
723552|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723553|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723554|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723555|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723556|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723557|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723558|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723559|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723560|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723561|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723562|NCT01721746|O2|Outcome|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723563|NCT01721746|O1|Outcome|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723564|NCT01721746|E2|Reported Event|Investigator's Choice (Dacarbazine or Carboplatin+Paclitaxel)|"Dacarbazine: 1000mg/m2, Powder for IV solution, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Carboplatin: Area under the concentration-time curve (AUC) 6, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends~Paclitaxel: 175 mg/ m2, solution for injection, IV, every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends"
723565|NCT01721746|E1|Reported Event|Nivolumab 3 mg/kg (IV)|Nivolumab 3 mg/kg solution for injection by intravenous (IV), every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
723566|NCT01721564|B1|Baseline|Bosentan|62.5 mg Bosentan b.i.d. for 1 month 125 mg Bosentan b.i.d. for 5 months
723567|NCT01721564|P1|Participant Flow|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
723573|NCT01721486|B1|Baseline|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
723574|NCT01721486|P2|Participant Flow|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
723575|NCT01721486|P1|Participant Flow|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
723576|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
723577|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
723578|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
723579|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
723580|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
723581|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
723582|NCT01721486|O2|Outcome|Control Group|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.
723583|NCT01721486|O1|Outcome|Study Group|IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion after IV placement in OR in study group only.
723584|NCT01721486|E2|Reported Event|Control Group|"PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30 minutes) prior to induction of anesthesia in the pre-operative area.~PO acetaminophen: PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area."
723585|NCT01721486|E1|Reported Event|Study Group|"IV acetaminophen 15 mg/kg (up to 1000 mg) administered intraoperatively over a 15 minute infusion.~IV acetaminophen: IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR in study group only."
723586|NCT01721330|B3|Baseline|Total|Total of all reporting groups
723587|NCT01721330|B2|Baseline|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
723588|NCT01721330|B1|Baseline|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
723589|NCT01721330|P2|Participant Flow|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
723590|NCT01721330|P1|Participant Flow|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
723591|NCT01721330|O2|Outcome|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
723592|NCT01721330|O1|Outcome|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
723593|NCT01721330|E2|Reported Event|Placebo|"Naltrexone-masked placebo administered twice daily up to a maximum total dose of 100mg/day.~Placebo: Placebo twice a day for 6 weeks"
723594|NCT01721330|E1|Reported Event|Naltrexone|"Active Naltrexone administered twice daily up to a maximum total dose of 100mg/day.~Naltrexone: Up to 100mg of Naltrexone once a day for 6 weeks"
723595|NCT01721317|B3|Baseline|Total|Total of all reporting groups
723596|NCT01721317|B2|Baseline|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723597|NCT01721317|B1|Baseline|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723598|NCT01721317|P2|Participant Flow|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 milligrams (mg)/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723599|NCT01721317|P1|Participant Flow|Placebo|Participants received matching ezogabine/retigabine IR placebo orally three times a day (TID) in equally or unequally divided doses.
723600|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723601|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723602|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723603|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723744|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723604|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723605|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723606|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723607|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723608|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723609|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723610|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723611|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723612|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723613|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723614|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723615|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723616|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723617|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723618|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723619|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723620|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723621|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723622|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723623|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723624|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723625|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723626|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723627|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723628|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723629|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723630|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723631|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723632|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723633|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723634|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723635|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723636|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723638|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723639|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723640|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723641|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723642|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723643|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723644|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723645|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723646|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723647|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723648|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723649|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723650|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723651|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723652|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723653|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723654|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723655|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723656|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723657|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723658|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723659|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723660|NCT01721317|O2|Outcome|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723661|NCT01721317|O1|Outcome|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723662|NCT01721317|E2|Reported Event|Ezogabine/Retigabine IR|Participants received investigator-selected daily doses of 600 mg/day, 750 mg/day, 900 mg/day, 1050 mg/day or 1200 mg/day of ezogabine/retigabine IR. The study drug was taken orally TID in equally or unequally divided doses.
723663|NCT01721317|E1|Reported Event|Placebo|Participants received matching ezogabine/retigabine IR placebo orally TID in equally or unequally divided doses.
723664|NCT01721226|B3|Baseline|Total|Total of all reporting groups
723665|NCT01721226|B2|Baseline|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723666|NCT01721226|B1|Baseline|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723667|NCT01721226|P2|Participant Flow|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
724169|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
723703|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723668|NCT01721226|P1|Participant Flow|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723669|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723670|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723671|NCT01721226|O2|Outcome|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723672|NCT01721226|O1|Outcome|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723673|NCT01721226|E2|Reported Event|CARE Tool and Cell Phone/Text Messaging|The Intervention Arm will complete the CARE tool device, a technology based HIV-counseling tool, and will receive text message reminders about HIV medical appointments and the importance of taking HIV medications. Study participants in this arm will be followed after release/study enrollment, just like participants in the Control Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723674|NCT01721226|E1|Reported Event|Control Arm|Participants in the Control Arm will receive standard discharge services according to the standards of care for that facility. In addition, participants in this arm will view an educational video on opiate overdose prevention. Study participants in the Control Arm will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
723675|NCT01721161|B3|Baseline|Total|Total of all reporting groups
723676|NCT01721161|B2|Baseline|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723677|NCT01721161|B1|Baseline|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723678|NCT01721161|P2|Participant Flow|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723679|NCT01721161|P1|Participant Flow|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723680|NCT01721161|O1|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723681|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723682|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723683|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723684|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723685|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723686|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723687|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723688|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723689|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723690|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723691|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723692|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723693|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723694|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723695|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723696|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723697|NCT01721161|O2|Outcome|BIIB033|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723698|NCT01721161|O1|Outcome|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723699|NCT01721161|E2|Reported Event|BIIB033 100 mg/kg|BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723700|NCT01721161|E1|Reported Event|Placebo|Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
723701|NCT01721109|B1|Baseline|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723702|NCT01721109|P1|Participant Flow|EVG/COBI/FTC/TDF|Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; EVG/COBI/FTC/TDF) (150/150/200/300 mg) single-tablet regiment (STR) administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase.
723704|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723705|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723706|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723707|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723708|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723709|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723710|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723711|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723712|NCT01721109|O1|Outcome|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723713|NCT01721109|E1|Reported Event|EVG/COBI/FTC/TDF|EVG/COBI/FTC/TDF (150/150/200/300 mg) STR administered orally once daily with food for 48 weeks, followed by EVG/COBI/FTC/TDF (150/150/200/300 mg) during the optional extension phase
723714|NCT01721096|B3|Baseline|Total|Total of all reporting groups
723715|NCT01721096|B2|Baseline|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723716|NCT01721096|B1|Baseline|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723717|NCT01721096|P2|Participant Flow|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723718|NCT01721096|P1|Participant Flow|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723719|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723720|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723721|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723722|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723723|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723724|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723725|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723726|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723727|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723728|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723729|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723730|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723731|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723732|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723733|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723734|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723735|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723736|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723737|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723738|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723739|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723740|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723741|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723742|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
724170|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
723745|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723746|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723747|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723748|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723749|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723750|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723751|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723752|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723753|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723754|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723755|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723756|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723757|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723758|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723759|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723760|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723761|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723762|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723763|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723764|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723765|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723766|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723767|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723768|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723769|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723770|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723771|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723772|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723773|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723774|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723775|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723776|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723777|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723778|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723779|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723780|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723781|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723782|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723783|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723784|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723785|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723786|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723787|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723788|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723789|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
724285|NCT01717989|O3|Outcome|June 2011|
724171|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
723790|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723791|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723792|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723793|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723794|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723795|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723796|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723797|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723798|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723799|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723800|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723801|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723802|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723803|NCT01721096|O2|Outcome|XIENCE PRIME - Core Size|"213 patients with 8, 12, 15, 18 or 23 mm stents~XIENCE PRIME - Core Size: Core Size"
723804|NCT01721096|O1|Outcome|XIENCE PRIME - Long Length (LL)|"323 patients receiving LL stent in 28, 33, or 38 mm length~XIENCE PRIME - Long Length (LL): Long Length"
723805|NCT01721096|E2|Reported Event|XIENCE PRIME - Core Size (CS)|XIENCE PRIME - Core Size: Core Size- 213 patients with 8, 12, 15, 18 or 23 mm stents.
723806|NCT01721096|E1|Reported Event|XIENCE PRIME - Long Length (LL)|XIENCE PRIME - Long Length (LL): Long Length- 323 patients receiving LL stent in 28, 33, or 38 mm length.
723807|NCT01721070|B1|Baseline|SUF NT 15 mcg Then 3 Days of Ketoconazole and SUF NT 15 mcg|"Period 1: SUF NT 15 mcg administered once sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.~Period 2: Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
723808|NCT01721070|P1|Participant Flow|SUF NT 15 mcg Followed by Ketoconazole 400 mg + SUF NT 15 mcg|"Period 1: One SUF NT 15 mcg administered sublingually followed by Period 2.~Period 2: Ketoconazole 400 mg given daily for three days; One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT 15 mcg dosing to block the opioid effects of the sufentanil."
723809|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
723810|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
723811|NCT01721070|O2|Outcome|Ketoconazole 400 mg and SUF NT 15 mcg|"Ketoconazole 400 mg given orally daily for three days. One SUF NT 15 mcg is also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
723812|NCT01721070|O1|Outcome|SUF NT 15 mcg|One SUF NT 15 mcg administered sublingually. Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil.
723813|NCT01721070|E2|Reported Event|Ketoconazole 400 mg + SUF NT 15 mcg|"Ketoconazole 400 mg given daily for three days. One SUF NT 15 mcg was also co-administered sublingually with the third (last) ketoconazole dose.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
723814|NCT01721070|E1|Reported Event|SUF NT 15 mcg|"One SUF NT 15 mcg administered sublingually.~Subjects also received one dose of oral naltrexone 50 mg in the evening before and the morning of each SUF NT dosing to block the opioid effects of the sufentanil."
723815|NCT01721057|B4|Baseline|Total|Total of all reporting groups
723816|NCT01721057|B3|Baseline|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
723817|NCT01721057|B2|Baseline|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
723818|NCT01721057|B1|Baseline|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723819|NCT01721057|P7|Participant Flow|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.~Includes participants who were rescued to Baricitinib 4 mg."
723820|NCT01721057|P6|Participant Flow|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
723821|NCT01721057|P5|Participant Flow|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
723822|NCT01721057|P4|Participant Flow|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
723823|NCT01721057|P3|Participant Flow|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723824|NCT01721057|P2|Participant Flow|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723825|NCT01721057|P1|Participant Flow|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723826|NCT01721057|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
723827|NCT01721057|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
723828|NCT01721057|O2|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
723829|NCT01721057|O1|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
723830|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723831|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723832|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723833|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
723834|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723835|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723836|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723837|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723838|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723839|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Starting at Week 16, participants who are nonresponders will be rescued with baricitinib 4 mg orally daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
723840|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
723841|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723842|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723843|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723844|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723845|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723846|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723847|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723848|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723849|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723850|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723851|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants will continue to take background cDMARD therapy throughout study."
723852|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723853|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723854|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723855|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723856|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~. Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723857|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723858|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
724036|NCT01719003|P6|Participant Flow|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
723859|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723860|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723861|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723862|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants will continue to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723863|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
723864|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continue to take background cDMARD therapy throughout study."
723865|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723866|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723867|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723868|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723869|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723870|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723871|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723872|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723873|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723874|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723875|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through week 24.~Participants continued to take background cDMARD therapy throughout study."
723876|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through week 24.~Participants will continued to take background cDMARD therapy throughout study."
723877|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD) through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723878|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723879|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723880|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723881|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723882|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723883|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723884|NCT01721057|O3|Outcome|Baricitinib 4 mg|"Baricitinib 4 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723885|NCT01721057|O2|Outcome|Baricitinib 2 mg|"Baricitinib 2 mg PO QD through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723886|NCT01721057|O1|Outcome|Placebo|"Placebo administered orally (PO) once daily (QD)through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723887|NCT01721057|E7|Reported Event|Baricitinib 4 mg- Follow Up|"No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.~Includes participants who were rescued to Baricitinib 4 mg."
723888|NCT01721057|E6|Reported Event|Baricitinib 2 mg- Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
723889|NCT01721057|E5|Reported Event|Placebo-Follow Up|No study drug received. Participants return for safety follow-up visit 28 days after the last dose of study drug.
723890|NCT01721057|E4|Reported Event|Rescue|Baricitinib 4 mg administered PO QD through Week 24. Participants continued to take background cDMARD therapy throughout study.
723891|NCT01721057|E3|Reported Event|Baricitinib 4 Mg-Treatment Period|"Baricitinib 4 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723892|NCT01721057|E2|Reported Event|Baricitinib 2 Mg-Treatment Period|"Baricitinib 2 mg administered orally once daily through Week 24.~Participants continued to take background cDMARD therapy throughout study."
723893|NCT01721057|E1|Reported Event|Placebo-Treatment Period|"Placebo administered orally once daily through Week 24.~Participants continued to take background conventional disease-modifying antirheumatic drug (cDMARD) therapy throughout study."
723894|NCT01720797|B3|Baseline|Total|Total of all reporting groups
724286|NCT01717989|O2|Outcome|March 2011|
723895|NCT01720797|B2|Baseline|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
723896|NCT01720797|B1|Baseline|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
723897|NCT01720797|P2|Participant Flow|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
723898|NCT01720797|P1|Participant Flow|Micro-osteoperforation|"Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.~Micro-osteoperforation: Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.~Anesthestic: Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
723899|NCT01720797|O2|Outcome|Non Micro-osteoperforation|Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.
723900|NCT01720797|O1|Outcome|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
723901|NCT01720797|E2|Reported Event|Non Micro-osteoperforation|"Prior to intervention a swish of 5cc of chlorhexidine for one minute, twice, will take place. Chlorhexidine rinses are to begin twice a day for a week.~Chlorhexidine: Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week."
723902|NCT01720797|E1|Reported Event|Micro-osteoperforation|Minimally invasive micro-osteoperforation (PROPEL™) procedure used to achieve rapid orthodontic tooth movement. Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice. Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice, will take place. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
723903|NCT01720602|B1|Baseline|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
723904|NCT01720602|P1|Participant Flow|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
723905|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
723906|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
723907|NCT01720602|O1|Outcome|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
723908|NCT01720602|E1|Reported Event|Treatment (Vorinostat, AI Therapy)|"Patients receive vorinostat PO 5 days a week for 3 weeks. Patients also receive AI therapy comprising either anastrozole PO daily, letrozole PO daily, or exemestane PO daily for 4 weeks. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.~vorinostat: Given PO~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~positron emission tomography: Correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~fludeoxyglucose F 18: Correlative studies~laboratory biomarker analysis: Correlative studies"
723909|NCT01720316|B3|Baseline|Total|Total of all reporting groups
723910|NCT01720316|B2|Baseline|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723949|NCT01720316|O1|Outcome|Glycine Then Placebo|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
723911|NCT01720316|B1|Baseline|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723912|NCT01720316|P2|Participant Flow|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
723913|NCT01720316|P1|Participant Flow|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then the participant received open-label glycine for 6 weeks.
723914|NCT01720316|O4|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (amplitude) week 6 of glycine
723915|NCT01720316|O3|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 2|Subject2: Auditory ERPs (amplitude) baseline
723916|NCT01720316|O2|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (amplitude) week 6 of glycine
723917|NCT01720316|O1|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 1|Subject1: Auditory ERPs (amplitude) baseline
723918|NCT01720316|O4|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (gamma phase locking) week 6 of glycine
723919|NCT01720316|O3|Outcome|Auditory ERPs Gamma Baseline: Subject 2|Subject2: Auditory ERPs (gamma phase locking) baseline
723920|NCT01720316|O2|Outcome|Auditory ERPs Gamma 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (gamma phase locking) week 6 of glycine
723921|NCT01720316|O1|Outcome|Auditory ERPs Gamma Baseline: Subject 1|Subject1: Auditory ERPs (gamma phase locking) baseline
723922|NCT01720316|O4|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (amplitude) week 6 of glycine
723923|NCT01720316|O3|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 2|Subject2: Auditory ERPs (amplitude) baseline
723924|NCT01720316|O2|Outcome|Auditory ERPs Amplitude (Deg) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (amplitude) week 6 of glycine
723925|NCT01720316|O1|Outcome|Auditory ERPs Amplitude (Deg) Baseline: Subject 1|Subject1: Auditory ERPs (amplitude) baseline
723926|NCT01720316|O2|Outcome|Placebo|"placebo, TID dosing, 6 weeks~placebo"
723927|NCT01720316|O1|Outcome|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks~glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
723928|NCT01720316|O4|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 2|Subject2: Auditory ERPs (latency) week 6 of glycine
723929|NCT01720316|O3|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 2|Subject2: Auditory ERPs (latency) baseline
723930|NCT01720316|O2|Outcome|Auditory ERPs Latency (ms) 6 Weeks of Glycine: Subject 1|Subject1: Auditory ERPs (latency) week 6 of glycine
723931|NCT01720316|O1|Outcome|Auditory ERPs Latency (ms) Baseline: Subject 1|Subject1: Auditory ERPs (latency) baseline
723932|NCT01720316|O2|Outcome|Subject2: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
723933|NCT01720316|O1|Outcome|Subject1: Brain GABA/CR Ratio- Baseline/Week 6 of Glycine|Brain GABA/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
723934|NCT01720316|O2|Outcome|Subject2: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 2
723935|NCT01720316|O1|Outcome|Subject1: Brain Glutamate/CR Ratio- Baseline/Week 6 of Glycine|Brain glutamate/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
723936|NCT01720316|O2|Outcome|Subject 2:Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant
723937|NCT01720316|O1|Outcome|Subject1: Brain Glycine/CR Ratio at Baseline/Week 6 of Glycine|Brain glycine/CR ratio at baseline and week 6 of glycine for one participant: Subject 1
723938|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723939|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723940|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723941|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723942|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723943|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723944|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723945|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723946|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723947|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723948|NCT01720316|O2|Outcome|Placebo Then Glycine|"placebo, TID dosing, 6 weeks Double-blind~placebo"
723950|NCT01720316|O4|Outcome|Composite Score on Glycine, Open-label|"glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
723951|NCT01720316|O3|Outcome|Composite Score on Placebo|"placebo, TID dosing, 6 weeks Double-blind~placebo"
723952|NCT01720316|O2|Outcome|Composite Score on Glycine, Double-blind|"Glycine, up to 0.8 g/kg, administered with TID dosing for 6 weeks Double-blind~Glycine: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
723953|NCT01720316|O1|Outcome|Baseline|Composite Score at Baseline
723954|NCT01720316|O2|Outcome|Placebo, Then Glycine|One participant received placebo administered with TID dosing for 6 weeks, then the participant received glycine powder, up to 0.8 g/kg, TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723955|NCT01720316|O1|Outcome|Glycine, Then Placebo|One participant received glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks, then the participant received placebo TID dosing for 6 weeks, then open-label glycine for 6 weeks.
723956|NCT01720316|E2|Reported Event|Placebo|"placebo, TID dosing, 6 weeks~placebo"
723957|NCT01720316|E1|Reported Event|Glycine|"Glycine powder, up to 0.8 g/kg, administered with TID dosing for 6 weeks~glycine powder: Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine"
723958|NCT01720251|B4|Baseline|Total|Total of all reporting groups
723959|NCT01720251|B3|Baseline|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
723960|NCT01720251|B2|Baseline|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
723961|NCT01720251|B1|Baseline|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
723962|NCT01720251|P3|Participant Flow|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
723963|NCT01720251|P2|Participant Flow|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
723964|NCT01720251|P1|Participant Flow|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
723965|NCT01720251|O3|Outcome|AllerT Full Dose|"SC injections of AllerT 50-100 micrograms~AllerT full dose: SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56"
723966|NCT01720251|O2|Outcome|AllerT Low Dose|"SC injections of AllerT 25 or 50 micrograms~AllerT low dose: SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56"
723967|NCT01720251|O1|Outcome|Placebo|"SC injections of placebo~placebo: SC injections of placebo on days 1, 7, 14, 28 and 56"
723968|NCT01720251|E3|Reported Event|AllerT 100 µg|All patients having received at least one injection of Allert 100 µg (Safety Set)
723969|NCT01720251|E2|Reported Event|Allert 50 µg|All patients having received at least one injection of Allert 50 µg (Safety Set)
723970|NCT01720251|E1|Reported Event|Placebo|All patients having received at least one injection of Placebo (Safety Set)
723971|NCT01719861|B1|Baseline|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723972|NCT01719861|P1|Participant Flow|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723973|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723974|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723975|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723976|NCT01719861|O1|Outcome|Desipramine HCl|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723977|NCT01719861|O1|Outcome|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723978|NCT01719861|E1|Reported Event|Desipramine HCl 25 mg|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. By the end of the 6 weeks, patients will be taking 450 mg (maximum dosage) or a tolerable dose of desipramine without serious side effects.
723979|NCT01719757|B1|Baseline|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
723980|NCT01719757|P1|Participant Flow|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
723981|NCT01719757|O2|Outcome|Subject|For overall satisfaction assessement of oxycodone/naloxone by subject
723982|NCT01719757|O1|Outcome|Investigator|For overall satisfaction assessement of oxycodone/naloxone by investigator
724037|NCT01719003|P5|Participant Flow|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
723983|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
723984|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
723985|NCT01719757|O1|Outcome|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
723986|NCT01719757|E1|Reported Event|Oxycodone/Naloxone|"Trade name is Targin. Oxycodone (10mg)/naloxone (5mg) or Oxycodone (20mg)/naloxone (10mg) tablets. Twice daily per oral. Dose adjustment and asymmetric dose are allowed up to 80/40mg per day~Oxycodone/Naloxone: Twice daily"
723987|NCT01719653|B6|Baseline|Total|Total of all reporting groups
723988|NCT01719653|B5|Baseline|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
723989|NCT01719653|B4|Baseline|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
723990|NCT01719653|B3|Baseline|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
723991|NCT01719653|B2|Baseline|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
723992|NCT01719653|B1|Baseline|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
723993|NCT01719653|P5|Participant Flow|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
723994|NCT01719653|P4|Participant Flow|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
723995|NCT01719653|P3|Participant Flow|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
723996|NCT01719653|P2|Participant Flow|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
723997|NCT01719653|P1|Participant Flow|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
723998|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
723999|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
724000|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724001|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724002|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724003|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
724033|NCT01719003|P9|Participant Flow|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
724004|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
724005|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724006|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724007|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724008|NCT01719653|O5|Outcome|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
724009|NCT01719653|O4|Outcome|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
724010|NCT01719653|O3|Outcome|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724011|NCT01719653|O2|Outcome|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724012|NCT01719653|O1|Outcome|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724013|NCT01719653|E5|Reported Event|SUPREP (Split-Dose)|"SUPREP consumed as a split-dose as follows: SUPREP 16 oz consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 32 oz of clear liquids; SUPREP 16 oz consumed from 3-4 hours prior to the colonoscopy followed by 32 oz of clear liquids.~SUPREP: SUPREP consumed as described in each arm."
724014|NCT01719653|E4|Reported Event|MoviPrep (Split-Dose)|"MoviPrep consumed as a split-dose as follows: MoviPrep 1 liter consumed from about 6 PM to 7 PM the day prior to the colonoscopy followed by 0.5 liter of clear liquids; MoviPrep 1 liter consumed from 3-4 hours prior to the colonoscopy followed by 0.5 liter of clear liquids.~MoviPrep: MoviPrep consumed as described in each arm."
724015|NCT01719653|E3|Reported Event|MiraLAX 306 g (Split-Dose)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed as a split-dose as follows: Gatorade 32oz mixed with Miralax 153 g from about 6 PM to 8 PM the day prior to the colonoscopy; Gatorade 32oz mixed with Miralax 153 g from about 2-4 hours prior to the colonoscopy.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724016|NCT01719653|E2|Reported Event|MiraLAX 357 g (Day-Prior)|"MiraLAX 357 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 68 g at 12 noon; Gatorade 64 oz mixed with Miralax 289 g from about 6 PM to 9 PM.~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724017|NCT01719653|E1|Reported Event|MiraLAX 306 g (Day-Prior)|"MiraLAX 306 g and Gatorade 64 oz (1/2 gallon) consumed the day-prior to the colonoscopy as follows: Miralax 51 g at 12 noon; Gatorade 64 oz mixed with Miralax 255 g from about 6 PM to 9 PM~MiraLAX: MiraLAX consumed as described in each arm.~Gatorade: Gatorade consumed as described in each arm."
724018|NCT01719172|B1|Baseline|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
724019|NCT01719172|P1|Participant Flow|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
724020|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
724021|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
724022|NCT01719172|O1|Outcome|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
724023|NCT01719172|E1|Reported Event|Veriset™ Hemostatic Patch|Subjects received the topical hemostat Veriset™ Hemostatic Patch
724024|NCT01719003|B9|Baseline|Total|Total of all reporting groups
724025|NCT01719003|B8|Baseline|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
724026|NCT01719003|B7|Baseline|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
724027|NCT01719003|B6|Baseline|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
724028|NCT01719003|B5|Baseline|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
724029|NCT01719003|B4|Baseline|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
724030|NCT01719003|B3|Baseline|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
724031|NCT01719003|B2|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
724032|NCT01719003|B1|Baseline|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
724034|NCT01719003|P8|Participant Flow|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
724038|NCT01719003|P4|Participant Flow|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
724039|NCT01719003|P3|Participant Flow|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
724040|NCT01719003|P2|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
724041|NCT01719003|P1|Participant Flow|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
724042|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
724043|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
724044|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
724045|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
724046|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
724047|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
724048|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
724049|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
724050|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
724051|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
724052|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
724053|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
724054|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
724055|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
724056|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
724057|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
724058|NCT01719003|O8|Outcome|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
724059|NCT01719003|O7|Outcome|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
724060|NCT01719003|O6|Outcome|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
724061|NCT01719003|O5|Outcome|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
724062|NCT01719003|O4|Outcome|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
724063|NCT01719003|O3|Outcome|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
724064|NCT01719003|O2|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
724065|NCT01719003|O1|Outcome|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
724066|NCT01719003|E9|Reported Event|Empagliflozin 12.5 mg Bid + Metformin 1000 mg Bid OL|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg bid in an open label (OL)
724067|NCT01719003|E8|Reported Event|Metformin 500 mg Bid|Oral administration of Metformin 500 mg bid
724068|NCT01719003|E7|Reported Event|Metformin 1000 mg Bid|Oral administration of Metformin 1000 mg bid
724069|NCT01719003|E6|Reported Event|Empagliflozin 10 mg qd|Oral administration of Empagliflozin 10 mg qd
724070|NCT01719003|E5|Reported Event|Empagliflozin 25 mg qd|Oral administration of Empagliflozin 25 mg once daily (qd)
724071|NCT01719003|E4|Reported Event|Empagliflozin 5 mg Bid + Metformin 500 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 500 mg bid
724072|NCT01719003|E3|Reported Event|Empagliflozin 5 mg Bid + Metformin 1000 mg Bid|Oral administration of Empagliflozin 5 mg and Metformin 1000 mg bid
724073|NCT01719003|E2|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 500 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 500 mg bid
724074|NCT01719003|E1|Reported Event|Empagliflozin 12.5 mg Bid+ Metformin 1000 mg Bid|Oral administration of Empagliflozin 12.5 mg and Metformin 1000 mg twice daily (bid)
724075|NCT01718691|B3|Baseline|Total|Total of all reporting groups
724076|NCT01718691|B2|Baseline|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724077|NCT01718691|B1|Baseline|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724078|NCT01718691|P2|Participant Flow|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
724079|NCT01718691|P1|Participant Flow|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
724080|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724081|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
724082|NCT01718691|O1|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724083|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724084|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724085|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724086|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724087|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724088|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724090|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724091|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724092|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724093|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724094|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724095|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724096|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724097|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724098|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724099|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724100|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724101|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm.
724102|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma.
724103|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma.
724104|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724105|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724106|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724107|NCT01718691|O3|Outcome|Total|All subjects in the SyB L-0501＋ rituximab arm
724108|NCT01718691|O2|Outcome|Mantle Cell Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Mantle cell lymphoma
724109|NCT01718691|O1|Outcome|Low-grade B-cell Non-Hodgkin’s Lymphoma|Subjects in the SyB L-0501＋ rituximab arm with primary disease of Low-grade B-cell non-Hodgkin's lymphoma
724110|NCT01718691|E1|Reported Event|SyB L-0501＋Rituximab|"Drug: SyB L-0501~A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.~Drug: rituximab~A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0."
724111|NCT01718535|B11|Baseline|Total|Total of all reporting groups
724112|NCT01718535|B10|Baseline|*3/*17 CYP2C19 Genotype|
724113|NCT01718535|B9|Baseline|*2/*17 CYP2C19 Genotype|
724114|NCT01718535|B8|Baseline|*2/*3 CYP2C19 Genotype|
724115|NCT01718535|B7|Baseline|*17/*17 CYP2C19 Genotype|
724116|NCT01718535|B6|Baseline|*1/*17 CYP2C19 Genotype|
724117|NCT01718535|B5|Baseline|*3/*3 CYP2C19 Genotype|
724118|NCT01718535|B4|Baseline|*1/*3 CYP2C19 Genotype|
724119|NCT01718535|B3|Baseline|*2/*2 CYP2C19 Genotype|
724120|NCT01718535|B2|Baseline|*1/*2 CYP2C19 Genotype|
724121|NCT01718535|B1|Baseline|*1/*1 CYP2C19 Genotype|
724122|NCT01718535|P10|Participant Flow|*3/*17 CYP2C19 Genotype|
724123|NCT01718535|P9|Participant Flow|*2/*17 CYP2C19 Genotype|
724124|NCT01718535|P8|Participant Flow|*2/*3 CYP2C19 Genotype|
724125|NCT01718535|P7|Participant Flow|*17/*17 CYP2C19 Genotype|
724126|NCT01718535|P6|Participant Flow|*1/*17 CYP2C19 Genotype|
724127|NCT01718535|P5|Participant Flow|*3/*3 CYP2C19 Genotype|
724128|NCT01718535|P4|Participant Flow|*1/*3 CYP2C19 Genotype|
724129|NCT01718535|P3|Participant Flow|*2/*2 CYP2C19 Genotype|
724130|NCT01718535|P2|Participant Flow|*1/*2 CYP2C19 Genotype|
724131|NCT01718535|P1|Participant Flow|*1/*1 CYP2C19 Genotype|
724132|NCT01718535|O10|Outcome|*3/*17 CYP2C19 Genotype|
724133|NCT01718535|O9|Outcome|*2/*17 CYP2C19 Genotype|
724134|NCT01718535|O8|Outcome|*2/*3 CYP2C19 Genotype|
724135|NCT01718535|O7|Outcome|*17/*17 CYP2C19 Genotype|
724136|NCT01718535|O6|Outcome|*1/*17 CYP2C19 Genotype|
724137|NCT01718535|O5|Outcome|*3/*3 CYP2C19 Genotype|
724138|NCT01718535|O4|Outcome|*1/*3 CYP2C19 Genotype|
724139|NCT01718535|O3|Outcome|*2/*2 CYP2C19 Genotype|
724140|NCT01718535|O2|Outcome|*1/*2 CYP2C19 Genotype|
724141|NCT01718535|O1|Outcome|*1/*1 CYP2C19 Genotype|
724142|NCT01718535|E10|Reported Event|*3/*17 CYP2C19 Genotype|
724143|NCT01718535|E9|Reported Event|*2/*17 CYP2C19 Genotype|
724144|NCT01718535|E8|Reported Event|*2/*3 CYP2C19 Genotype|
724145|NCT01718535|E7|Reported Event|*17/*17 CYP2C19 Genotype|
724146|NCT01718535|E6|Reported Event|*1/*17 CYP2C19 Genotype|
724147|NCT01718535|E5|Reported Event|*3/*3 CYP2C19 Genotype|
724148|NCT01718535|E4|Reported Event|*1/*3 CYP2C19 Genotype|
724149|NCT01718535|E3|Reported Event|*2/*2 CYP2C19 Genotype|
724150|NCT01718535|E2|Reported Event|*1/*2 CYP2C19 Genotype|
724151|NCT01718535|E1|Reported Event|*1/*1 CYP2C19 Genotype|
724152|NCT01718509|B3|Baseline|Total|Total of all reporting groups
724153|NCT01718509|B2|Baseline|SPD489|
724154|NCT01718509|B1|Baseline|PLACEBO|
724155|NCT01718509|P2|Participant Flow|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
724191|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
724192|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
724193|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
724194|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
724195|NCT01718509|O2|Outcome|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
724196|NCT01718509|O1|Outcome|PLACEBO|Administered once-daily, orally, for up to 12 weeks
724197|NCT01718509|E2|Reported Event|SPD489|50 or 70 mg administered orally, once-daily for up to 12 weeks
724198|NCT01718509|E1|Reported Event|PLACEBO|Administered once-daily, orally, for up to 12 weeks
724199|NCT01718483|B3|Baseline|Total|Total of all reporting groups
724200|NCT01718483|B2|Baseline|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724201|NCT01718483|B1|Baseline|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724202|NCT01718483|P2|Participant Flow|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 milligram (mg) administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724203|NCT01718483|P1|Participant Flow|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily, for up to 12 weeks.
724204|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724205|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724206|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724207|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724208|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724209|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724210|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724211|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724212|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724213|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724214|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724215|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724216|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724217|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724218|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724219|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724220|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724221|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724222|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724223|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724224|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724225|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724226|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724227|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724228|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724229|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724230|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724231|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724232|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724233|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724234|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724235|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724236|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724237|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724337|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724238|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724239|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724240|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724241|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724242|NCT01718483|O2|Outcome|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724243|NCT01718483|O1|Outcome|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724244|NCT01718483|E2|Reported Event|SPD489|SPD489 capsule 30 (titration purpose only), 50 or 70 mg administered orally, once-daily for up to 12 weeks once the optimal dose is reached.
724245|NCT01718483|E1|Reported Event|PLACEBO|Placebo matching SPD489 capsule administered orally, once-daily for up to 12 weeks.
724246|NCT01718028|B3|Baseline|Total|Total of all reporting groups
724247|NCT01718028|B2|Baseline|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
724248|NCT01718028|B1|Baseline|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
724249|NCT01718028|P2|Participant Flow|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
724250|NCT01718028|P1|Participant Flow|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
724251|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
724252|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
724253|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
724254|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
724255|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
724256|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
724257|NCT01718028|O2|Outcome|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
724258|NCT01718028|O1|Outcome|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
724259|NCT01718028|E2|Reported Event|LARMABAK®|Sodium chloride 0.9% saline solution, 1 drop in each eye 4 times a day for 30 days
724260|NCT01718028|E1|Reported Event|SYSTANE® BALANCE|Propylene glycol 0.6% ocular emulsion, 1 drop in each eye 4 times a day for 30 days
724261|NCT01717989|B1|Baseline|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
724262|NCT01717989|P1|Participant Flow|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
724263|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
724264|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
724265|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
724266|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
724267|NCT01717989|O1|Outcome|2010|From June through December 2010
724268|NCT01717989|O5|Outcome|December 2011|
724269|NCT01717989|O4|Outcome|September 2011|
724270|NCT01717989|O3|Outcome|June 2011|
724271|NCT01717989|O2|Outcome|March 2011|
724272|NCT01717989|O1|Outcome|December 2010|
724273|NCT01717989|O5|Outcome|December 2011|
724274|NCT01717989|O4|Outcome|September 2011|
724275|NCT01717989|O3|Outcome|June 2011|
724276|NCT01717989|O2|Outcome|March 2011|
724277|NCT01717989|O1|Outcome|December 2010|
724278|NCT01717989|O5|Outcome|December 2011|
724279|NCT01717989|O4|Outcome|September 2011|
724280|NCT01717989|O3|Outcome|June 2011|
724281|NCT01717989|O2|Outcome|March 2011|
724282|NCT01717989|O1|Outcome|December 2010|
724283|NCT01717989|O5|Outcome|December 2011|
724284|NCT01717989|O4|Outcome|September 2011|
724318|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
724319|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
724320|NCT01717989|O5|Outcome|Q4 2011|Fourth quarter, 2011
724321|NCT01717989|O4|Outcome|Q3 2011|Third quarter (Q3) 2011
724322|NCT01717989|O3|Outcome|Q2 2011|Second quarter (Q2), 2011
724323|NCT01717989|O2|Outcome|Q1 2011|First quarter (Q1), 2011
724324|NCT01717989|O1|Outcome|Q4 2010|Fourth quarter (Q4) 2010
724325|NCT01717989|O1|Outcome|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
724326|NCT01717989|E1|Reported Event|Cohort|Patients with end-stage renal disease (ESRD) treated at small dialysis organizations (SDOs).
724327|NCT01717976|B3|Baseline|Total|Total of all reporting groups
724328|NCT01717976|B2|Baseline|Control|usual care
724329|NCT01717976|B1|Baseline|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724330|NCT01717976|P2|Participant Flow|Control|usual care
724331|NCT01717976|P1|Participant Flow|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724332|NCT01717976|O2|Outcome|Control|usual care
724333|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724334|NCT01717976|O2|Outcome|Control|usual care
724335|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724336|NCT01717976|O2|Outcome|Control|usual care
724338|NCT01717976|O2|Outcome|Control|usual care
724339|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724340|NCT01717976|O2|Outcome|Control|usual care
724341|NCT01717976|O1|Outcome|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724342|NCT01717976|E2|Reported Event|Control|usual care
724343|NCT01717976|E1|Reported Event|Intervention|"primary care based nurse telephone support~DISPO ED: primary care based nurse telephone support"
724344|NCT01717872|B3|Baseline|Total|Total of all reporting groups
724345|NCT01717872|B2|Baseline|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724346|NCT01717872|B1|Baseline|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724347|NCT01717872|P2|Participant Flow|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724348|NCT01717872|P1|Participant Flow|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724349|NCT01717872|O2|Outcome|MAC Blade Lifting the Epiglottis|The MAC blade was inserted under the epiglottis and lift to view the percent glottic opening
724350|NCT01717872|O1|Outcome|MAC Blade Lifting the Tongue|The MAC blade was inserted under the tongue and lifted to view the percent glottic opening
724351|NCT01717872|O2|Outcome|Miller Blade Lifting the Tongue|Miller blade was inserted under the tongue (above the epiglottis) to view the glottic opening
724352|NCT01717872|O1|Outcome|Miller Blade Lifting the Epiglottis|Miller blade was inserted under the epiglottis to lift it to view the glottic opening
724353|NCT01717872|O2|Outcome|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724354|NCT01717872|O1|Outcome|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The percent of glottic opening (POGO) score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724355|NCT01717872|E2|Reported Event|Miller Laryngoscope Blade|"A photo of the larynx will be taken with the Miller laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724356|NCT01717872|E1|Reported Event|Macintosh Laryngoscope Blade|"A photo of the larynx will be taken with the Macintosh laryngoscope blade lifting and not lifting the epiglottis. The view of the larynx will be assessed using the POGO score by a blinded assessor.~Laryngoscope blade: The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades while lifting or not lifting the epiglottis"
724357|NCT01717768|B11|Baseline|Total|Total of all reporting groups
724358|NCT01717768|B10|Baseline|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
725063|NCT01716754|E1|Reported Event|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
724359|NCT01717768|B9|Baseline|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724360|NCT01717768|B8|Baseline|Part 4 Cohort 2: 90 mg BID/ 90 mg TID|"Oral TSX-002 90 mg BID for 15 days then 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724361|NCT01717768|B7|Baseline|Part 4 Cohort 1: 60 mg BID/ 60 mg TID|"Oral TSX-002 60 mg BID for 15 days then 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724362|NCT01717768|B6|Baseline|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724382|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
724383|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
725463|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
724363|NCT01717768|B5|Baseline|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724364|NCT01717768|B4|Baseline|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724365|NCT01717768|B3|Baseline|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724366|NCT01717768|B2|Baseline|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724367|NCT01717768|B1|Baseline|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724368|NCT01717768|P12|Participant Flow|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724369|NCT01717768|P11|Participant Flow|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724370|NCT01717768|P10|Participant Flow|Part 4 Cohort 2: 90 mg TID|Oral TSX-002 90 mg TID for 15 days
724371|NCT01717768|P9|Participant Flow|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724372|NCT01717768|P8|Participant Flow|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002 are capsules with testosterone as the active ingredient."
724373|NCT01717768|P7|Participant Flow|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724374|NCT01717768|P6|Participant Flow|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
724375|NCT01717768|P5|Participant Flow|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing."
724376|NCT01717768|P4|Participant Flow|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724377|NCT01717768|P3|Participant Flow|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724378|NCT01717768|P2|Participant Flow|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724379|NCT01717768|P1|Participant Flow|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724380|NCT01717768|O3|Outcome|Part 3:120 mg QD Treatment C|Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
724381|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
724707|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724384|NCT01717768|O2|Outcome|Part 3:120 mg QD Treatment B|Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
724385|NCT01717768|O1|Outcome|Part 3:120 mg QD Treatment A|Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.
724386|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724387|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724388|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724389|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724390|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
724391|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724392|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724393|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724394|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724395|NCT01717768|O9|Outcome|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724396|NCT01717768|O8|Outcome|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724397|NCT01717768|O7|Outcome|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724398|NCT01717768|O6|Outcome|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724399|NCT01717768|O5|Outcome|Part 4 Cohort 1: 60 mg TID|Oral TSX-002 60 mg three times daily (TID) for 15 days
724400|NCT01717768|O4|Outcome|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724401|NCT01717768|O3|Outcome|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724402|NCT01717768|O2|Outcome|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724403|NCT01717768|O1|Outcome|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724404|NCT01717768|E12|Reported Event|Part 4 Cohort 4: 120 mg BID|"Oral TSX-002 120 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724405|NCT01717768|E11|Reported Event|Part 4 Cohort 3: 180 mg QD|"Oral TSX-002 180 mg once daily (QD) for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724406|NCT01717768|E10|Reported Event|Part 4 Cohort 2: 90 mg TID|"Oral TSX-002 90 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724407|NCT01717768|E9|Reported Event|Part 4 Cohort 2: 90 mg BID|"Oral TSX-002 90 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724408|NCT01717768|E8|Reported Event|Part 4 Cohort 1: 60 mg TID|"Oral TSX-002 60 mg TID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724409|NCT01717768|E7|Reported Event|Part 4 Cohort 1: 60 mg BID|"Oral TSX-002 60 mg BID for 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724431|NCT01717638|P12|Participant Flow|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
725442|NCT01715298|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
724410|NCT01717768|E6|Reported Event|Part 3: C-A-B 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724411|NCT01717768|E5|Reported Event|Part 3: B-C-A 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
725464|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
724412|NCT01717768|E4|Reported Event|Part 3: A-B-C 120 mg QD|"Open-label, randomized, 3-way crossover of 3 treatments, A, B, and C.~Treatment A: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes after a high-calorie, high-fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment B: Oral TSX-002 (1 x 120-mg capsules) administered 4 hours after a high-calorie, high fat meal. No food was allowed 4 hours before the high calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~Treatment C: Oral TSX-002 (1 x 120-mg capsules) administered 30 minutes before a high-calorie, high-fat meal. No food was allowed 4 hours before the high-calorie, high-fat meal and no food was allowed for at least 10 hours after dosing.~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724413|NCT01717768|E3|Reported Event|Part 2: 120 mg BID|"Single cohort, open-label, nonrandomized oral TSX 002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724414|NCT01717768|E2|Reported Event|Part 1: 240 mg BID|"Oral TSX-002 240 mg BID (total dose = 480 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724415|NCT01717768|E1|Reported Event|Part 1: 120 mg BID|"Oral TSX-002 120 mg BID (total dose = 240 mg/day) for a duration of 15 days~TSX-002: TSX-002 are capsules with testosterone as the active ingredient."
724416|NCT01717638|B14|Baseline|Total|Total of all reporting groups
724417|NCT01717638|B13|Baseline|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724418|NCT01717638|B12|Baseline|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724419|NCT01717638|B11|Baseline|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724420|NCT01717638|B10|Baseline|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724421|NCT01717638|B9|Baseline|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724422|NCT01717638|B8|Baseline|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724423|NCT01717638|B7|Baseline|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724424|NCT01717638|B6|Baseline|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724425|NCT01717638|B5|Baseline|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724426|NCT01717638|B4|Baseline|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724427|NCT01717638|B3|Baseline|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724428|NCT01717638|B2|Baseline|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724429|NCT01717638|B1|Baseline|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724430|NCT01717638|P13|Participant Flow|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724432|NCT01717638|P11|Participant Flow|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724433|NCT01717638|P10|Participant Flow|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724434|NCT01717638|P9|Participant Flow|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724435|NCT01717638|P8|Participant Flow|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724436|NCT01717638|P7|Participant Flow|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724488|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724437|NCT01717638|P6|Participant Flow|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724438|NCT01717638|P5|Participant Flow|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724439|NCT01717638|P4|Participant Flow|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724440|NCT01717638|P3|Participant Flow|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724441|NCT01717638|P2|Participant Flow|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724442|NCT01717638|P1|Participant Flow|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724443|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724444|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724445|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724446|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724447|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724448|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724449|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724450|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724451|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724452|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724453|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724454|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724455|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724456|NCT01717638|O2|Outcome|B48 50 (After 2nd Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724457|NCT01717638|O1|Outcome|B48 50 (After 1st Dose)|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724458|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724459|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724460|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724586|NCT01717456|P2|Participant Flow|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724461|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724462|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724463|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724464|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724465|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724466|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724467|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724468|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724469|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724470|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724471|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724472|NCT01717638|O1|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724473|NCT01717638|O1|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724474|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724475|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724476|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724477|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724478|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724479|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724480|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724481|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724482|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724483|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
725443|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
724484|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724485|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724486|NCT01717638|O4|Outcome|B48_50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724487|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724681|NCT01717326|P14|Participant Flow|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724489|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724490|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724491|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724492|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724493|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724494|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724495|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724496|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724497|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724498|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724499|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724500|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724501|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724502|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724503|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724504|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724505|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724506|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724507|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724532|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724508|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724509|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724510|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724511|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
726002|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo during double blind period
724512|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724513|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724514|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724515|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724516|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724517|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724518|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724519|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724520|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724521|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724522|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724523|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724524|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724525|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724526|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724527|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724528|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724529|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724530|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724531|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724533|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724534|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724535|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724536|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724537|NCT01717638|O4|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724538|NCT01717638|O3|Outcome|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724539|NCT01717638|O2|Outcome|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects from this group received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724540|NCT01717638|O1|Outcome|B12 14_48|Previously received routine vaccines at 2,4 and 6 months of age, followed by two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724541|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724542|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724543|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724544|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724545|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724546|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724547|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724548|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724549|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724550|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724551|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724552|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724553|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724554|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724555|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724556|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724557|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724558|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724559|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724560|NCT01717638|O10|Outcome|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724561|NCT01717638|O9|Outcome|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724562|NCT01717638|O8|Outcome|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724563|NCT01717638|O7|Outcome|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724564|NCT01717638|O6|Outcome|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724565|NCT01717638|O5|Outcome|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724566|NCT01717638|O4|Outcome|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724567|NCT01717638|O3|Outcome|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724568|NCT01717638|O2|Outcome|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724569|NCT01717638|O1|Outcome|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724570|NCT01717638|E13|Reported Event|B48 50|Newly recruited 4 year old naive subjects who received 2 catch-up doses of rMenB+OMV NZ vaccine, two months apart, in the present study.
724571|NCT01717638|E12|Reported Event|B24 26_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 & 26 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724572|NCT01717638|E11|Reported Event|B18 20_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 & 20 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724573|NCT01717638|E10|Reported Event|B12 14_48|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 &14 months of age. All subjects received a 3rd dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724574|NCT01717638|E9|Reported Event|B+R234_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724575|NCT01717638|E8|Reported Event|B+R234_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724576|NCT01717638|E7|Reported Event|B+R234_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12months of age. All subjects received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724577|NCT01717638|E6|Reported Event|B246_24_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724578|NCT01717638|E5|Reported Event|B246_18_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724579|NCT01717638|E4|Reported Event|B246_12_48|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724580|NCT01717638|E3|Reported Event|B+R246_24_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724581|NCT01717638|E2|Reported Event|B+R246_18_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724582|NCT01717638|E1|Reported Event|B+R246_12_48|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age. One third of subjects from this group received a 5th dose of rMenB+OMV NZ vaccine in the present study at 4 years of age.
724583|NCT01717456|B3|Baseline|Total|Total of all reporting groups
724584|NCT01717456|B2|Baseline|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724585|NCT01717456|B1|Baseline|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
727812|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
724587|NCT01717456|P1|Participant Flow|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [Miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
724588|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724589|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724590|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724591|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724592|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724593|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724594|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724595|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724596|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724597|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724598|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724599|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724600|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724601|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724602|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724603|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724604|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724674|NCT01717326|B1|Baseline|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724605|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724606|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724607|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724608|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724609|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724610|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724611|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724612|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724613|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724614|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724615|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724616|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724617|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724618|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724619|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724620|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724621|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724622|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724623|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724624|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724625|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724626|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724675|NCT01717326|P20|Participant Flow|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724627|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724628|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724629|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724630|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724631|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724632|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724633|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724634|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724635|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724636|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724637|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
724638|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724639|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
724640|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724641|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724642|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724643|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724644|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724645|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724646|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724647|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724648|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724676|NCT01717326|P19|Participant Flow|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724649|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724650|NCT01717456|O2|Outcome|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724651|NCT01717456|O1|Outcome|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives or anti-diarrheals [miralax 1-2 packets (17-34 g)/day or Imodium 0.5-2 tablets (1-4 mg)/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, daily diary, and protective pads or garments [as needed].
724652|NCT01717456|E2|Reported Event|Standard Care|Standard care includes fiber supplements 1-4 packets (3.4-13.6 g)/day], daily diary, and protective pads or garments [as needed].
724653|NCT01717456|E1|Reported Event|Educational-Medical-Behavioral|Educational-Medical-Behavioral intervention includes education, fiber supplements [Metamucil 1-4 packets (3.4-13.6 g)/day], laxatives [Mirilax 1-2 packets or 17-34 g/day] or anti-diarrheal medication [Imodium 1-4 mg/day], pelvic floor muscle exercises [100 10-second squeezes/day], tips on how to prevent fecal incontinence, and use of a daily diary and protective pads or garments [if needed].
724654|NCT01717326|B21|Baseline|Total|Total of all reporting groups
724655|NCT01717326|B20|Baseline|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724656|NCT01717326|B19|Baseline|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724657|NCT01717326|B18|Baseline|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724658|NCT01717326|B17|Baseline|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724659|NCT01717326|B16|Baseline|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724660|NCT01717326|B15|Baseline|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724661|NCT01717326|B14|Baseline|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724662|NCT01717326|B13|Baseline|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724663|NCT01717326|B12|Baseline|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724664|NCT01717326|B11|Baseline|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724665|NCT01717326|B10|Baseline|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724666|NCT01717326|B9|Baseline|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724667|NCT01717326|B8|Baseline|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724668|NCT01717326|B7|Baseline|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724669|NCT01717326|B6|Baseline|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724670|NCT01717326|B5|Baseline|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724671|NCT01717326|B4|Baseline|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724672|NCT01717326|B3|Baseline|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724673|NCT01717326|B2|Baseline|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
725016|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
724677|NCT01717326|P18|Participant Flow|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724678|NCT01717326|P17|Participant Flow|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724679|NCT01717326|P16|Participant Flow|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724680|NCT01717326|P15|Participant Flow|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
727813|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
724682|NCT01717326|P13|Participant Flow|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724683|NCT01717326|P12|Participant Flow|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724684|NCT01717326|P11|Participant Flow|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724685|NCT01717326|P10|Participant Flow|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724686|NCT01717326|P9|Participant Flow|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724687|NCT01717326|P8|Participant Flow|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724688|NCT01717326|P7|Participant Flow|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724689|NCT01717326|P6|Participant Flow|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724690|NCT01717326|P5|Participant Flow|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724691|NCT01717326|P4|Participant Flow|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724692|NCT01717326|P3|Participant Flow|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724693|NCT01717326|P2|Participant Flow|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724694|NCT01717326|P1|Participant Flow|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724695|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724696|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724697|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724698|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724699|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724700|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724701|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
725061|NCT01716754|E3|Reported Event|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
724702|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724703|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724704|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724705|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724706|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724708|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724709|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724710|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724711|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724712|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724713|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724714|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724715|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724716|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724717|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724718|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724719|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724720|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724721|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724722|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724723|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724724|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724725|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724726|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724727|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724728|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724729|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724730|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724731|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724732|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724757|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724733|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724734|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724735|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724736|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724737|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724738|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724739|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724740|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724741|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724742|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724743|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724744|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724745|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724746|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724747|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724748|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724749|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724750|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724751|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724752|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
725011|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
724753|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724754|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724755|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724756|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724758|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724759|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724760|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724761|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724762|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724763|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724764|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724765|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724766|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724767|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724768|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724769|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724770|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724771|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724772|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724773|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724774|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724775|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724776|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724777|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724778|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724779|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724780|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724781|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724782|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724783|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724784|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724785|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724786|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724787|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724788|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724789|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724790|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724791|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724792|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724793|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724794|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724795|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724796|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724797|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724798|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724799|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724800|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724801|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724802|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724803|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724804|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724805|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724806|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724807|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724808|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724809|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724810|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724811|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724812|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724813|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724814|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724815|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724816|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724817|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724818|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724819|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724820|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724821|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724822|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724823|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724824|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724825|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724826|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724827|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724828|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724829|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724830|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724831|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724832|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724833|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724834|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724835|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724836|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724837|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724838|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724839|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724840|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724841|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724842|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724843|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724844|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724845|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724846|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724847|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724848|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724849|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724850|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724851|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724852|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724853|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724854|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724855|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724856|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724857|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724858|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724859|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724885|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724860|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724861|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724862|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724863|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724864|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724865|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724866|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724867|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724868|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724869|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724870|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724871|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724872|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724873|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724874|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724875|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724876|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724877|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724878|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724879|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
725012|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
724880|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724881|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724882|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724883|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724884|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724886|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724887|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724888|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724889|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724890|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724891|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724892|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724893|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724894|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724895|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724896|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724897|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724898|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724899|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724900|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724901|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724902|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724903|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724904|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724905|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724906|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724907|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724908|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724909|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724910|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
725022|NCT01717040|P2|Participant Flow|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
724911|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724912|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724913|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724914|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724915|NCT01717326|O20|Outcome|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724916|NCT01717326|O19|Outcome|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724917|NCT01717326|O18|Outcome|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724918|NCT01717326|O17|Outcome|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724919|NCT01717326|O16|Outcome|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724920|NCT01717326|O15|Outcome|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724921|NCT01717326|O14|Outcome|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724922|NCT01717326|O13|Outcome|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724923|NCT01717326|O12|Outcome|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724924|NCT01717326|O11|Outcome|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724925|NCT01717326|O10|Outcome|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724926|NCT01717326|O9|Outcome|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724927|NCT01717326|O8|Outcome|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724928|NCT01717326|O7|Outcome|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724929|NCT01717326|O6|Outcome|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724930|NCT01717326|O5|Outcome|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
725013|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
724931|NCT01717326|O4|Outcome|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724932|NCT01717326|O3|Outcome|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724933|NCT01717326|O2|Outcome|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724934|NCT01717326|O1|Outcome|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
725465|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
724935|NCT01717326|E20|Reported Event|D2: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, and RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724936|NCT01717326|E19|Reported Event|D1: TN NC/GT3 Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT3 participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, and RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724937|NCT01717326|E18|Reported Event|C2: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks and Elbasvir 50 mg capsule orally QD for 8 weeks.
724938|NCT01717326|E17|Reported Event|C1: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1b participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, and RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724939|NCT01717326|E16|Reported Event|B13: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724940|NCT01717326|E15|Reported Event|B12: TN HIV NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724941|NCT01717326|E14|Reported Event|B11: NR Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724942|NCT01717326|E13|Reported Event|B10: NR Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724943|NCT01717326|E12|Reported Event|B9: NR Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724944|NCT01717326|E11|Reported Event|B8: NR Grazoprevir 100 mg + Elbasvir 50 mg +RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724945|NCT01717326|E10|Reported Event|B7: TN C Grazoprevir 100 mg + Elbasvir 50 Mg-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks.
724946|NCT01717326|E9|Reported Event|B6: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-18 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 18 weeks, Elbasvir 50 mg capsule orally QD for 18 weeks, RBV capsules orally BID for 18 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724947|NCT01717326|E8|Reported Event|B5: TN C Grazoprevir 100 mg + Elbasvir 50 mg for 12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724948|NCT01717326|E7|Reported Event|B4: TN C Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724949|NCT01717326|E6|Reported Event|B3: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724950|NCT01717326|E5|Reported Event|B2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a/non-a participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks, RBV capsules orally BID for 12 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724951|NCT01717326|E4|Reported Event|B1: TN NC/GT1a Grazoprevir 100 mg + Elbasvir 50 mg + RBV-8 wk|GT1a only participants receive Grazoprevir 100 mg tablet orally QD for 8 weeks, Elbasvir 50 mg capsule orally QD for 8 weeks, RBV capsules orally BID for 8 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724952|NCT01717326|E3|Reported Event|A3: TN NC/GT1b Grazoprevir 100 mg + Elbasvir 50 Mg-12 wk|GT1b only participants receive Grazoprevr 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule orally QD for 12 weeks.
724953|NCT01717326|E2|Reported Event|A2: TN NC Grazoprevir 100 mg + Elbasvir 50 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally QD for 12 weeks, Elbasvir 50 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally BID for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724954|NCT01717326|E1|Reported Event|A1: TN NC Grazoprevir 100 mg + Elbasvir 20 mg + RBV-12 wk|GT1a and GT1b participants receive Grazoprevir 100 mg tablet orally once daily (QD) for 12 weeks, Elbasvir 20 mg capsule and Placebo capsule orally QD for 12 weeks, RBV capsules orally twice daily (BID) for 24 weeks at a total daily dose from 800 to 1400 mg based on participant weight.
724955|NCT01717313|B3|Baseline|Total|Total of all reporting groups
725062|NCT01716754|E2|Reported Event|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
724956|NCT01717313|B2|Baseline|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724957|NCT01717313|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
725023|NCT01717040|P1|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
725510|NCT01715064|O2|Outcome|Exercise|1 hour of moderate intensity exercise.
724958|NCT01717313|P2|Participant Flow|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724959|NCT01717313|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724960|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724961|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724962|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724963|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724964|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724965|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724966|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724967|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724968|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724969|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724970|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
725014|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
724971|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724972|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724973|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724974|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724975|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724976|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724977|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724978|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724979|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724980|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724981|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724982|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724983|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724984|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724985|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
725015|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
727777|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
724986|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724987|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724988|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724989|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724990|NCT01717313|O2|Outcome|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724991|NCT01717313|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724992|NCT01717313|E2|Reported Event|Placebo to Omarigliptin|Placebo to omarigliptin administered orally once a week for 24 weeks (Phase A) followed by placebo to omarigliptin administered orally once a week plus metformin daily for an additional 30 weeks (Phase B). Open-label metformin was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724993|NCT01717313|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks (Phase A) followed by omarigliptin 25 mg administered orally once a week plus placebo to metformin daily (Phase B). Open-label metformin daily was to be initiated for participants meeting protocol-specified glycemic criteria during Phase A, but was otherwise prohibited. Open-label glimepiride daily may be initiated as glycemic rescue therapy during Phase B.
724994|NCT01717287|B3|Baseline|Total|Total of all reporting groups
724995|NCT01717287|B2|Baseline|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
724996|NCT01717287|B1|Baseline|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
724997|NCT01717287|P2|Participant Flow|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
724998|NCT01717287|P1|Participant Flow|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
724999|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725000|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725001|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725002|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725003|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725004|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725005|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725006|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725007|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725008|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725009|NCT01717287|O2|Outcome|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725010|NCT01717287|O1|Outcome|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725017|NCT01717287|E2|Reported Event|Raltegravir Chewable Tablet|Raltegravir chewable tablet weight-based dose up to 300 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks
725018|NCT01717287|E1|Reported Event|Raltegravir Film-coated Tablet|Raltegravir film-coated tablet 400 mg administered orally twice-daily, in combination with other anti-retroviral therapy for 24 weeks.
725019|NCT01717040|B3|Baseline|Total|Total of all reporting groups
725020|NCT01717040|B2|Baseline|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
725021|NCT01717040|B1|Baseline|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
725024|NCT01717040|O2|Outcome|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
725025|NCT01717040|O1|Outcome|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
725026|NCT01717040|E2|Reported Event|Placebo|Placebo: Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
725027|NCT01717040|E1|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
725028|NCT01717014|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725029|NCT01717014|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725030|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725031|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725032|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725033|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725034|NCT01717014|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725035|NCT01717014|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in open low anterior resection or anterior proctosigmoidectomy
725036|NCT01716754|B5|Baseline|Total|Total of all reporting groups
725037|NCT01716754|B4|Baseline|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
725038|NCT01716754|B3|Baseline|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
725039|NCT01716754|B2|Baseline|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
725040|NCT01716754|B1|Baseline|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
725041|NCT01716754|P4|Participant Flow|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab.
725042|NCT01716754|P3|Participant Flow|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
725043|NCT01716754|P2|Participant Flow|QGE031 Low Dose|Participants received QGE031 36 mg q2w or 18 mg q2w.
725044|NCT01716754|P1|Participant Flow|QGE031 High Dose|Participants received QGE031 240 mg q2w, 240 mg q4w, 180 mg q2w or 120 mg q2w.
725045|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
725046|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
725047|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
725048|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
725049|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
725050|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
725051|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
725052|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
725053|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
725054|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
725055|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
725056|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
725057|NCT01716754|O3|Outcome|Omalizumab|Participants received omalizumab as per locally approved dosing table q2w or q4w.
725058|NCT01716754|O2|Outcome|Placebo to QGE031 240 mg q2w|Participants received placebo to QGE031 240 mg q2w
725059|NCT01716754|O1|Outcome|QGE031 240 mg q2w|Participants received QGE031 240 mg q2w.
725060|NCT01716754|E4|Reported Event|Placebo Total|Participants received matching placebo to QGE031 or Omalizumab
725064|NCT01716663|B1|Baseline|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725065|NCT01716663|P1|Participant Flow|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725066|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725159|NCT01716234|P4|Participant Flow|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725067|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725068|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725069|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725070|NCT01716663|O1|Outcome|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725071|NCT01716663|E1|Reported Event|Experimental: Catheter Ablation|"These patients have drug refractory recurrent symptomatic paroxysmal AF, are 18 years and older, and are able and willing to provide written informed consent to participate in the study and comply with study requirements.~Catheter Ablation: NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)"
725072|NCT01716585|B3|Baseline|Total|Total of all reporting groups
725073|NCT01716585|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
725074|NCT01716585|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725075|NCT01716585|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725076|NCT01716585|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725077|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725078|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725079|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725080|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725081|NCT01716585|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
725082|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725083|NCT01716585|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725084|NCT01716585|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725085|NCT01716585|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
725086|NCT01716585|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
725087|NCT01716559|B1|Baseline|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725088|NCT01716559|P1|Participant Flow|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta (NeoRecormon) subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725089|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725090|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725091|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725092|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725093|NCT01716559|O1|Outcome|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725094|NCT01716559|E1|Reported Event|Epoetin Beta|Participants receiving 30,000 International units (IU) of Epoetin beta subcutaneously by prefilled pen injection once a week for 16 weeks were observed.
725095|NCT01716520|B1|Baseline|UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|All participants received one of the following three treatments in one of three treatment periods QD from the DPI for 14 days: UMEC 62.5 µg inhalation powder; VI 25 µg inhalation powder; and UMEC/VI 62.5/25 µg inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg; (2) VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg; (3) UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg; (4) UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg; (5) VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg; (6) UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg. The three treatment periods were separated by a washout period of 10 to 14 days.
725096|NCT01716520|P6|Participant Flow|Sequence 6: UMEC/VI 62.5/25 µg, VI 25 µg, UMEC 62.5 µg|Participants received UMEC/VI 62.5/25 µg, VI 25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
725097|NCT01716520|P5|Participant Flow|Sequence 5: VI 25 µg, UMEC 62.5 µg, UMEC/VI 62.5/25 µg|Participants received VI 25 µg, UMEC 62.5 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
725098|NCT01716520|P4|Participant Flow|Sequence 4: UMEC 62.5 µg, UMEC/VI 62.5/25 µg, VI 25 µg|Participants received UMEC 62.5 µg, UMEC/VI 62.5/25 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
725099|NCT01716520|P3|Participant Flow|Sequence 3: UMEC/VI 62.5/25 µg, UMEC 62.5 µg, VI 25 µg|Participants received UMEC/VI 62.5/25 µg, UMEC 62.5 µg, and VI 25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
725100|NCT01716520|P2|Participant Flow|Sequence 2: VI 25 µg, UMEC/VI 62.5/25 µg, UMEC 62.5 µg|Participants received VI 25 µg, UMEC/VI 62.5/25 µg, and UMEC 62.5 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments QD for 14 days from a DPI. The three treatment periods were separated by a washout period of 10 to 14 days.
725101|NCT01716520|P1|Participant Flow|Sequence 1: UMEC 62.5 µg, VI 25 µg, UMEC/VI 62.5/25 µg|Participants received umeclidinium (UMEC) 62.5 micrograms (µg), vilanterol (VI) 25 µg, and UMEC/VI 62.5/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (QD) for 14 days from a Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 10 to 14 days.
725102|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725103|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725104|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725105|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725106|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725107|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725108|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725109|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725110|NCT01716520|O3|Outcome|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725111|NCT01716520|O2|Outcome|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725112|NCT01716520|O1|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725113|NCT01716520|E3|Reported Event|UMEC/VI 62.5/25 µg|Participants received UMEC/VI 62.5/25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725444|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725114|NCT01716520|E2|Reported Event|VI 25 µg|Participants received VI 25 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725115|NCT01716520|E1|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg inhalation powder QD from the DPI for 14 days during one of the three treatment periods. Each treatment period was followed by a washout period of 10-14 days.
725116|NCT01716468|B1|Baseline|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
725117|NCT01716468|P1|Participant Flow|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
725457|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725118|NCT01716468|O1|Outcome|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
725119|NCT01716468|E1|Reported Event|Advanced or Metastatic Cancer|Patients chosen must be diagnosed with advanced or metastatic cancer of the following tumor types (colorectal, prostate, brain, breast, pancreatic, hepatobiliary, melanoma, sarcoma, non-small cell /small cell lung, genitourinary cancers).
725120|NCT01716455|B7|Baseline|Total|Total of all reporting groups
725121|NCT01716455|B6|Baseline|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725122|NCT01716455|B5|Baseline|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725123|NCT01716455|B4|Baseline|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725124|NCT01716455|B3|Baseline|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725125|NCT01716455|B2|Baseline|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725126|NCT01716455|B1|Baseline|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725127|NCT01716455|P6|Participant Flow|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725128|NCT01716455|P5|Participant Flow|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725129|NCT01716455|P4|Participant Flow|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725130|NCT01716455|P3|Participant Flow|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725131|NCT01716455|P2|Participant Flow|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725132|NCT01716455|P1|Participant Flow|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725133|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725134|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725135|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725136|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725137|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725138|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725139|NCT01716455|O6|Outcome|SSP-004184 (Healthy Elderly Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725140|NCT01716455|O5|Outcome|SSP-004184 (Matched Healthy Subjects)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725141|NCT01716455|O4|Outcome|SSP-004184 (End Stage Renal Disease)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725142|NCT01716455|O3|Outcome|SSP-004184 (Severe Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725143|NCT01716455|O2|Outcome|SSP-004184 (Moderate Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725144|NCT01716455|O1|Outcome|SSP-004184 (Mild Renal Impairment)|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725145|NCT01716455|E3|Reported Event|Healthy Elderly Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725146|NCT01716455|E2|Reported Event|Matched Healthy Subjects|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725147|NCT01716455|E1|Reported Event|Impaired Renal Function|All subjects took a single oral dose of SSP-004184 (75 mg/kg) on Day 1
725148|NCT01716234|B8|Baseline|Total|Total of all reporting groups
725149|NCT01716234|B7|Baseline|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725150|NCT01716234|B6|Baseline|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725151|NCT01716234|B5|Baseline|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725152|NCT01716234|B4|Baseline|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725153|NCT01716234|B3|Baseline|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725154|NCT01716234|B2|Baseline|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725155|NCT01716234|B1|Baseline|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725156|NCT01716234|P7|Participant Flow|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725157|NCT01716234|P6|Participant Flow|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725158|NCT01716234|P5|Participant Flow|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725458|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725160|NCT01716234|P3|Participant Flow|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725161|NCT01716234|P2|Participant Flow|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725162|NCT01716234|P1|Participant Flow|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725163|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725164|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725165|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725166|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725167|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725168|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725169|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725170|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725171|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725172|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725173|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725174|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725175|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725176|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725177|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725178|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725179|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725180|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725181|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725182|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725183|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725184|NCT01716234|O7|Outcome|POS 12 TID 3 Months to <2 Years|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725185|NCT01716234|O6|Outcome|POS 18 TID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725186|NCT01716234|O5|Outcome|POS 18 TID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725187|NCT01716234|O4|Outcome|POS 18 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725188|NCT01716234|O3|Outcome|POS 18 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725189|NCT01716234|O2|Outcome|POS 12 BID 7 to <18 Years|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725190|NCT01716234|O1|Outcome|POS 12 BID 2 to <7 Years|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725191|NCT01716234|E7|Reported Event|POS 12 TID 3 Months to <2 Yrs|Participants aged 3 months to <2 years received posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725192|NCT01716234|E6|Reported Event|POS 18 TID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725193|NCT01716234|E5|Reported Event|POS 18 TID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) until recovery from neutropenia or up to 28 days.
725194|NCT01716234|E4|Reported Event|POS 18 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725195|NCT01716234|E3|Reported Event|POS 18 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725196|NCT01716234|E2|Reported Event|POS 12 BID 7 to <18 Yrs|Participants aged 7 to <18 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725197|NCT01716234|E1|Reported Event|POS 12 BID 2 to <7 Yrs|Participants aged 2 to <7 years received posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) until recovery from neutropenia or up to 28 days.
725198|NCT01716221|B1|Baseline|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
725199|NCT01716221|P1|Participant Flow|Study Participant|the participant received all intervention combinations in the following order: bupropion & Citalopram, then Bupropion & Placebo, then Placebo & Citalopram, then Placebo & Placebo
725200|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
725201|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
725202|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
725203|NCT01716221|O2|Outcome|Citalopram (Week 5)|
725204|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
725205|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
725206|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
725207|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
725208|NCT01716221|O2|Outcome|Citalopram (Week 5)|
725209|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
725210|NCT01716221|O5|Outcome|Bupropion + Citalopram (Week 20)|
725211|NCT01716221|O4|Outcome|Bupropion Only (Week 15)|
725212|NCT01716221|O3|Outcome|OFF - Bupropion Placebo + Citalopram Placebo (Week 10)|
725213|NCT01716221|O2|Outcome|Citalopram (Week 5)|
725214|NCT01716221|O1|Outcome|Baseline - Unblinded on Buproprion and Citalopram|
725215|NCT01716221|O5|Outcome|Baseline|unblinded 100mg Bupropion & 20mg Citalopram
725216|NCT01716221|O4|Outcome|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
725217|NCT01716221|O3|Outcome|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
725218|NCT01716221|O2|Outcome|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
725219|NCT01716221|O1|Outcome|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day or 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
725220|NCT01716221|E4|Reported Event|Placebo & Placebo|"Placebo & Placebo taken orally one time per day~Placebo & Placebo"
725221|NCT01716221|E3|Reported Event|Placebo & Citalopram|"Placebo & 20mg Citalopram taken orally one time per day or Placebo & 10mg Citalopram taken orally one time per day~Placebo & Citalopram"
725222|NCT01716221|E2|Reported Event|Bupropion & Placebo|"100mg Bupropion & Placebo taken orally one time per day or 50mg Bupropion & Placebo taken orally one time per day~Bupropion & Placebo"
725223|NCT01716221|E1|Reported Event|Bupropion & Citalopram|"100mg Bupropion & 20mg Citalopram taken orally one time per day or 100mg Bupropion & 10mg Citalopram taken orally one time per day or 50mg Bupropion & 20mg Citalopram taken orally one time per day 0r 50mg Bupropion & 10mg Citalopram taken orally one time per day~bupropion & Citalopram"
725224|NCT01716169|B1|Baseline|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
725225|NCT01716169|P1|Participant Flow|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
725226|NCT01716169|O2|Outcome|Standard of Care Dressing - Chronic Wound|Standard of Care dressings will be applied to one chronic wound
725227|NCT01716169|O1|Outcome|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
725228|NCT01716169|E2|Reported Event|Standard of Care - Chronic Wound|Standard of Care wound dressings (e.g. Vaseline gauze) will be applied to one chronic wound (of approximately 6 months duration) if the subject has more than one chronic wound of approximately the same size and duration as Helicoll chronic wound.
725445|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725229|NCT01716169|E1|Reported Event|Helicoll - Chronic Wound|"Helicoll will be applied to one chronic wound (approximately 6 months or more duration)~Helicoll: Helicoll Collagen I Wound Dressing"
725230|NCT01716156|B4|Baseline|Total|Total of all reporting groups
725231|NCT01716156|B3|Baseline|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
725232|NCT01716156|B2|Baseline|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725459|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725511|NCT01715064|O1|Outcome|Control|non-exercise control consisting of movie watching.
725233|NCT01716156|B1|Baseline|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725234|NCT01716156|P3|Participant Flow|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
725235|NCT01716156|P2|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks Plus Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725236|NCT01716156|P1|Participant Flow|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725237|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
725238|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725239|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725240|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
725241|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725242|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725243|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
725244|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725245|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725246|NCT01716156|O3|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
725247|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 12 Weeks Extended|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725248|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725249|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV HCV GT1non-a|This group consisted of all participants with HCV GT1non-a infection, pooled across treatment arms.
725250|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV HCV GT1a|This group consisted of all participants with HCV GT1a infection pooled across treatment arms.
725251|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
725252|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
727778|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
725253|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
725254|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
725255|NCT01716156|O2|Outcome|Grazoprevir 100 mg + RBV 24 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 24 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 24 weeks.
725460|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725256|NCT01716156|O1|Outcome|Grazoprevir 100 mg + RBV 12 Weeks|Grazoprevir 100 mg tablet once per day by mouth for 12 weeks and RBV capsules twice per day by mouth at a total daily dose from 800 to 1400 mg based on participant weight for 12 weeks. Participants with detectable HCV RNA at TW4 received an additional 12 weeks of study therapy for a total of 24 weeks of treatment.
725257|NCT01716156|E2|Reported Event|Grazoprevir 100 mg + RBV: up to 12 Weeks|The up to 12 weeks group consists of participants in the APaT population who only received 12 weeks of treatment and not those originally assigned to 12 weeks that went on to receive 24 total weeks of treatment.
725258|NCT01716156|E1|Reported Event|Grazoprevir 100 mg + RBV: Beyond 12 Weeks|The beyond 12 weeks group consists of participants in the APaT population who received 24 total weeks of treatment, regardless of original treatment regimen assignment.
725259|NCT01716052|B3|Baseline|Total|Total of all reporting groups
725260|NCT01716052|B2|Baseline|Placebo|"Lactulose~placebo: Lactulose"
725261|NCT01716052|B1|Baseline|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
725262|NCT01716052|P2|Participant Flow|Placebo|"Lactulose~placebo: Lactulose"
725263|NCT01716052|P1|Participant Flow|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
725264|NCT01716052|O2|Outcome|Placebo|"Lactulose~placebo: Lactulose"
725265|NCT01716052|O1|Outcome|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
725266|NCT01716052|E2|Reported Event|Placebo|"Lactulose~placebo: Lactulose"
725267|NCT01716052|E1|Reported Event|Ibuprofen|"Pfizer 200 mg caplets (Advil)~Ibuprofen"
725268|NCT01716013|B3|Baseline|Total|Total of all reporting groups
725269|NCT01716013|B2|Baseline|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
725270|NCT01716013|B1|Baseline|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
725271|NCT01716013|P2|Participant Flow|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
725272|NCT01716013|P1|Participant Flow|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
725273|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
725274|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
725275|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
725276|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
725277|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
725278|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
725279|NCT01716013|O2|Outcome|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
725280|NCT01716013|O1|Outcome|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
725281|NCT01716013|E2|Reported Event|CWCD|"Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips~CWCD: traditional closure methods of sutures, staples or adhesive strips"
725282|NCT01716013|E1|Reported Event|BondEase|"Topical Skin Adhesive~BondEase: topical skin adhesive"
725283|NCT01715948|B1|Baseline|A Comparison Between Wireless CROS and BAHD for SSD|"Participants who have been implanted with a BAHD over the past three years will be given a two-week trial period with a CROS hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~CROS hearing aid: BAHD users will be fitted with the CROS hearing aid for a two-week trial period. Their hearing abilities with the CROS hearing aid will be compared to their hearing abilities with their BAHD over a two-week period."
725284|NCT01715948|P1|Participant Flow|Contralateral Routing of Signals (CROS) Hearing Aid|"Participants who have been implanted with a bone-anchored hearing device (BAHD) over the past three years will be given a two-week trial period with a Contralateral Routing of Signals (CROS) hearing aid. The CROS uses two hearing aids that fit behind each ear. The hearing aid fitted on the side of the poor ear houses a microphone and a transmitter. The hearing aid fitted on the normal ear side houses a receiver that is connected to an open ear tip. Sounds on the side of the poor ear are picked up by the microphone and transmitted to the opposite normal ear, overcoming the head shadow effect that presents with unilateral deafness.~Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries."
725285|NCT01715948|O6|Outcome|SSQ Subscale - Qualities (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
725286|NCT01715948|O5|Outcome|SSQ Subscale - Qualities (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Qualities subscale of the SSQ on a 10-point scale.
725287|NCT01715948|O4|Outcome|SSQ Subscale - Spatial (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
725446|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725288|NCT01715948|O3|Outcome|SSQ Subscale - Spatial (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Spatial subscale of the SSQ on a 10-point scale.
725289|NCT01715948|O2|Outcome|SSQ Subscale - Speech (CROS)|Participants rated the effectiveness of the CROS for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
725290|NCT01715948|O1|Outcome|SSQ Subscale - Speech (BAHD)|Participants rated the effectiveness of the BAHD for listening situations included in the Speech subscale of the SSQ on a 10-point scale.
725461|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725291|NCT01715948|O3|Outcome|WRS in Quiet to Poorer Ear|Word recognition was tested with no noise (quiet) with words presented at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
725292|NCT01715948|O2|Outcome|WRS Noise to Poorer Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the poorer ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
725293|NCT01715948|O1|Outcome|WRS Noise to Better Ear|Word recognition was tested with words presented from the front and multitalker noise (at 45 dB HL) at 90 degrees azimuth to the better ear. This occurred across three randomized listening conditions: unaided, BAHD and CROS.
725294|NCT01715948|O6|Outcome|QuickSIN Noise to Poorer Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the CROS.
725295|NCT01715948|O5|Outcome|QuickSIN Noise to Poorer Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing the BAHD.
725296|NCT01715948|O4|Outcome|QuickSIN Noise to Poorer Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the poorer ear while wearing no device.
725297|NCT01715948|O3|Outcome|QuickSIN Noise to Better Ear With CROS|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the CROS.
725298|NCT01715948|O2|Outcome|QuickSIN Noise to Better Ear With BAHD|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing the BAHD.
725299|NCT01715948|O1|Outcome|QuickSIN Noise to Better Ear Unaided|Two different lists of sentences presented at 0 degree azimuth and multitalker noise presented at 90 degrees azimuth to the better ear while wearing no device. The multitalker noise increases with each sentence presentation such that the signal-to-noise ratio decreases from 25 to 0 dB, in 5-dB steps, over the six sentences.
725300|NCT01715948|E2|Reported Event|CROS Aid|The intervention during which the CROS aid was trialed as part of the cross-over design
725301|NCT01715948|E1|Reported Event|BAHD|The intervention during which the BAHD was trialed as part of the cross-over design
725302|NCT01715896|B3|Baseline|Total|Total of all reporting groups
725303|NCT01715896|B2|Baseline|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725304|NCT01715896|B1|Baseline|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725305|NCT01715896|P2|Participant Flow|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725306|NCT01715896|P1|Participant Flow|Golimumab 50 Milligram (mg) Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725307|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725308|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725309|NCT01715896|O1|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725310|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725311|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725312|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725313|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725314|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725447|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725315|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725316|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725317|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725318|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725319|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725320|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725321|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725322|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725323|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725324|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725325|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725326|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725327|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725328|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725329|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725330|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725331|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725332|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725333|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725334|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725335|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725336|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725448|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725449|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725337|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725338|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725339|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725340|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725341|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725342|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725343|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725344|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725345|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725346|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725347|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725348|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725349|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725350|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725351|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725352|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725353|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725354|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725355|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725356|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725357|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725358|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725450|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725451|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725359|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725360|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725361|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725362|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725363|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725364|NCT01715896|O2|Outcome|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725365|NCT01715896|O1|Outcome|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725366|NCT01715896|E2|Reported Event|Mavrilimumab 100 mg|Participants received mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725367|NCT01715896|E1|Reported Event|Golimumab 50 mg Alternating With Placebo|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
725368|NCT01715857|B1|Baseline|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725369|NCT01715857|P1|Participant Flow|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725370|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725371|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725372|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725373|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725374|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725375|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725376|NCT01715857|O1|Outcome|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725377|NCT01715857|E1|Reported Event|Chinese Patients Requiring Surgery With Sevoflurane Anesthesia|Participants who were scheduled for surgery requiring sevoflurane anesthesia with endotracheal intubation or laryngeal mask airway (LMA) per approved product information of sevoflurane in China
725378|NCT01715831|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725379|NCT01715831|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received disease-modifying anti-rheumatic drugs (DMARDs) in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725380|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
727779|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
725381|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725462|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725512|NCT01715064|E2|Reported Event|Exercise|1 hour of moderate intensity exercise.
725382|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725383|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725384|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725385|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725386|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725387|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725388|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725389|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725390|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725391|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725392|NCT01715831|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725393|NCT01715831|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 104 weeks. The maximum single dose administered to any participant was 800 mg of tocilizumab. Participants might have also received DMARDs in addition to the tocilizumab treatment in any visit, at the investigator discretion, according to the local prescription information and participant's tolerance.
725394|NCT01714336|B3|Baseline|Total|Total of all reporting groups
725395|NCT01714336|B2|Baseline|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725396|NCT01714336|B1|Baseline|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725397|NCT01714336|P2|Participant Flow|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725398|NCT01714336|P1|Participant Flow|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725399|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725400|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725401|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725402|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725403|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725404|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725405|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725406|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725407|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725408|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725409|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725410|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725411|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725412|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725413|NCT01714336|O2|Outcome|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725414|NCT01714336|O1|Outcome|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725452|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725453|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725415|NCT01714336|E2|Reported Event|Tranexamic Acid|"Tranexamic acid will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~tranexamic acid: Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure."
725416|NCT01714336|E1|Reported Event|Placebo|"Normal saline will be administered intravenously in two doses of 15 mg/kg each administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.~placebo: A similar dose of 0.9% NaCL will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure."
725417|NCT01714232|B1|Baseline|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
725418|NCT01714232|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
725419|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
725420|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
725421|NCT01714232|O1|Outcome|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
725422|NCT01714232|E1|Reported Event|Study Staff Test BGMSs|All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
725423|NCT01715415|B3|Baseline|Total|Total of all reporting groups
725424|NCT01715415|B2|Baseline|Placebo|Double-blind placebo for 12 weeks
725425|NCT01715415|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725426|NCT01715415|P2|Participant Flow|Placebo Followed by ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725427|NCT01715415|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725428|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725429|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725430|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725431|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725432|NCT01715415|O2|Outcome|Placebo|Double-blind placebo for 12 weeks
725433|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725434|NCT01715415|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725435|NCT01715415|E3|Reported Event|Open Label ABT-450/r/ABT-267 and ABT-333, Plus RBV|Open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725436|NCT01715415|E2|Reported Event|Double Blind Placebo|Double-blind placebo for 12 weeks
725437|NCT01715415|E1|Reported Event|Double Blind ABT-450/r/ABT-267 and ABT-333, Plus RBV|Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 to 1,200 mg/day divided twice daily) for 12 weeks
725438|NCT01715298|B3|Baseline|Total|Total of all reporting groups
725439|NCT01715298|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725440|NCT01715298|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725441|NCT01715298|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725454|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725455|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725456|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725513|NCT01715064|E1|Reported Event|Control|non-exercise control consisting of movie watching.
725466|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725467|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725468|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725469|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725470|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725471|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725472|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725473|NCT01715298|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725474|NCT01715298|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725475|NCT01715298|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725476|NCT01715298|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
725477|NCT01715207|B3|Baseline|Total|Total of all reporting groups
725478|NCT01715207|B2|Baseline|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
725479|NCT01715207|B1|Baseline|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
725480|NCT01715207|P2|Participant Flow|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
725481|NCT01715207|P1|Participant Flow|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
725482|NCT01715207|O2|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Control group baseline 24 Weeks Central PWV (m/s)(26) by MRI regional PWV A (level 1-2) 3.8 (1.7) 3.6 (1.23) PWV-total (level 1-4) 5.0 (1.03) 4.9 (1.24)"
725483|NCT01715207|O1|Outcome|Atenolol and Aliskiren|Aliskiren (Norvatis) 300mg oral tablet
725484|NCT01715207|O2|Outcome|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Atenolol"
725485|NCT01715207|O1|Outcome|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Aliskiren~Atenolol"
725486|NCT01715207|E2|Reported Event|Atenolol|"Atenolol tablet(Negative controls, Open-label)~Control (n=14) Overall rate of adverse events 10 (71.4%) moderate to severe cases 2 (14.3%) generalized symptoms 4 (28.6%) gastrointestinal symptoms 3 (21.4%) lung problems 1 (7.1%) cardiovascular symptoms 0 central nervous system symptoms 1 (7.1%) Eye, nose, throat symptoms 1 (7.1%) gynecologic problems 1 (7.1%) problems of extremities 2 (14.3%)"
725487|NCT01715207|E1|Reported Event|Atenolol & Aliskiren|"Atenolol tablet and Aliskiren 150mg or 300mg tablet by mouth per day for 6month~Treatment (n=14) Overall rate of adverse events 12 (85.7%) moderate to severe cases 0 generalized symptoms 8 (57.1%) gastrointestinal symptoms 4 (28.6%) lung problems 0 cardiovascular symptoms 3 (21.4%) central nervous system symptoms 5 (35.7%) Eye, nose, throat symptoms 4 (28.6%) gynecologic problems 1 (7.1%) problems of extremities 1 (7.1%)"
725488|NCT01715129|B1|Baseline|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725489|NCT01715129|P1|Participant Flow|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725490|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725491|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725492|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725493|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725494|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725495|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725496|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725497|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725498|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725499|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725500|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725501|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725502|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725503|NCT01715129|O1|Outcome|Triptorelin Pamoate|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725504|NCT01715129|E1|Reported Event|Triptorelin Pamoate 11.25 mg|Triptorelin Pamoate corresponding to 11.25 mg of triptorelin administered subcutaneously on Day 1 and 92
725505|NCT01715064|B3|Baseline|Total|Total of all reporting groups
725506|NCT01715064|B2|Baseline|Exercise|1 hour of moderate intensity exercise.
725507|NCT01715064|B1|Baseline|Control|non-exercise control consisting of movie watching.
725508|NCT01715064|P2|Participant Flow|Exercise (1hr of Mixed-modality Exercise)|1 hour of moderate intensity exercise. The session included 5- min warm-up, 25-min of resistance training, 25-min of aerobic training, and 5-min cool-down. Each session was led by a personal trainer and supervised by an exercise physiologist.
725509|NCT01715064|P1|Participant Flow|Control (1hr of Viewing Emotionally Neutral Movie)|non-exercise control consisting of movie watching for 60 mins. the videos were short cartoon films considered to be emotionally neutral.
725515|NCT01714635|B3|Baseline|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
725516|NCT01714635|B2|Baseline|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725517|NCT01714635|B1|Baseline|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725518|NCT01714635|P3|Participant Flow|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
725519|NCT01714635|P2|Participant Flow|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725520|NCT01714635|P1|Participant Flow|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725521|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
725522|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725523|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725524|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
725525|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725526|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725527|NCT01714635|O3|Outcome|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
725528|NCT01714635|O2|Outcome|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725529|NCT01714635|O1|Outcome|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725530|NCT01714635|E3|Reported Event|Monofocal Intraocular Lens|"Commercially available monofocal intraocular lens (IOL)~Monofocal Intraocular Lens"
725531|NCT01714635|E2|Reported Event|Tecnis Multifocal Intraocular Lens #2|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725532|NCT01714635|E1|Reported Event|Tecnis Multifocal Intraocular Lens #1|"A low diopter add multifocal intraocular lens~Tecnis Multifocal Intraocular Lens"
725533|NCT01714609|B3|Baseline|Total|Total of all reporting groups
725534|NCT01714609|B2|Baseline|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
725535|NCT01714609|B1|Baseline|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
725536|NCT01714609|P2|Participant Flow|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
725537|NCT01714609|P1|Participant Flow|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
725538|NCT01714609|O2|Outcome|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
725539|NCT01714609|O1|Outcome|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
725540|NCT01714609|E2|Reported Event|Sorafenib|"Subjects randomized to Sorafenib will take Sorafenib 400 mg by mouth twice daily.~Sorafenib: Sorafenib, 400 mg twice daily"
725541|NCT01714609|E1|Reported Event|Placebo|"Subjects randomized to placebo will take two tablets of placebo by mouth twice daily.~Placebo: Placebo Comparator: Placebo"
725542|NCT01714544|B1|Baseline|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
725543|NCT01714544|P1|Participant Flow|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
725544|NCT01714544|O1|Outcome|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
725545|NCT01714544|E1|Reported Event|Cloderm Cream|"Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days~Cloderm Cream"
725649|NCT01713608|E1|Reported Event|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
725650|NCT01713530|B3|Baseline|Total|Total of all reporting groups
725546|NCT01714505|B1|Baseline|Open and Closed Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
725547|NCT01714505|P2|Participant Flow|Closed-Loop Then Open-Loop Control|"Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia.~Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings."
725557|NCT01714492|B1|Baseline|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725558|NCT01714492|P1|Participant Flow|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725548|NCT01714505|P1|Participant Flow|Open-Loop Then Closed-Loop Control|"Open-Loop: Insulin delivery will be controlled by the DiAs system running in open-loop mode. The subject will interact with the system through its GUI. Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings.~Closed-Loop: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia."
725549|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
725550|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
725551|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
725552|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
725553|NCT01714505|O2|Outcome|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
725554|NCT01714505|O1|Outcome|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
725729|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
725555|NCT01714505|E2|Reported Event|Open-Loop CGM-Augmented Insulin Pump Therapy|Open Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in open-loop mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will be permitted to administer correction boluses at any time during the Control Admission, whether or not they are eating a scheduled meal or snack. DiAs will be initialized with the subject's typical insulin pump settings. The subject will be reminded that all treatment decisions should be based on fingerstick values and not on continuous glucose monitor (CGM) values.
725556|NCT01714505|E1|Reported Event|Closed-loop Control to Range|"Closed-Loop Control: Insulin delivery will be controlled by the Diabetes Assistant (DiAs) system running in Control to Range (CTR) or in Safety Only mode. The subject will interact with the system through its Graphic User Interface (GUI). Subjects will not be allowed to administer correction boluses between meals and snacks as the DiAs will automatically be adjusting insulin to correct for hyperglycemia. The total doses recommended by the DiAs prior to meals and snacks includes the correction dose and Insulin on Board (IOB) calculated by the system.~Diabetes Assistant (DiAs): A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night."
725559|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725560|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725561|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725562|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725563|NCT01714492|O1|Outcome|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725564|NCT01714492|O1|Outcome|In Vivo Knee Kinematics From Fluoroscopy Evaluation During Dee|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725565|NCT01714492|E1|Reported Event|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|subjects implanted with the Sigma Posterior Stabilizing Rotating Platform TKA including a polyethylene insert with 4 beads that allow for determination of polyethylene rotation.
725566|NCT01713998|B4|Baseline|Total|Total of all reporting groups
725567|NCT01713998|B3|Baseline|Group C|Subjects received Ultherapy® treatment using standard (highest) energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer used at the second highest energy setting on one side of the upper face and the 7-4.5mm transducer at the standard (highest) energy setting on the contralateral side of the upper face.
725568|NCT01713998|B2|Baseline|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
725569|NCT01713998|B1|Baseline|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
725570|NCT01713998|P3|Participant Flow|Group C|Subjects received an increased density guideline treatment over the full face. The upper face treatment was provided in a split-face treatment using the 4 MHz transducer at no higher than the second highest energy setting on one side of the upper face and the 7 MHz transducer at the highest energy setting on other side of the upper face.
725571|NCT01713998|P2|Participant Flow|Group B|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the lowest level of four possible energy settings on one side of the face.
725572|NCT01713998|P1|Participant Flow|Group A|Subjects received an increased density guideline treatment over the full face but with the energy reduced to the second highest level of four possible energy settings on one side of the face.
725573|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
725574|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
725575|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
726079|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
725576|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
725577|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
725578|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
725579|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4-4.5mm transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7-4.5mm transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7-4.5mm transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4-4.5mm transducer at the second highest energy setting and the corresponding lower face side.
725792|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725580|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
725581|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
725582|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted) second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For Group C, the standard energy side is defined as the upper face side treated with the 7 MHz transducer at the highest energy setting and the corresponding lower face side; the adjusted energy side is defined as the upper face side treated with 4 MHz transducer at the second highest energy setting and the corresponding lower face side.
725583|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
725584|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
725585|NCT01713998|O3|Outcome|Group C|Subjects received a standard Ultherapy® treatment using the (standard) highest energy settings on both sides of the lower face and neck. On the upper face (brow), the 4 MHz transducer was used at the (adjusted)second highest energy setting on one side of the upper face, and the 7 MHz transducer at the (standard) highest energy setting on the contralateral side of the upper face. For this outcome measure, only pain score data reported for the brow regions (using standard versus adjusted energy settings) were included.
725586|NCT01713998|O2|Outcome|Group B|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the lowest level of four possible energy settings on the contralateral side of the face.
725587|NCT01713998|O1|Outcome|Group A|Subjects received Ultherapy® treatment using standard (highest) energy settings on one side of the face, and energy adjusted down to the second highest level of four possible energy settings on the contralateral side of the face.
725588|NCT01713998|E1|Reported Event|Study Population|Includes all subjects meeting entrance criteria, consented for participation, enrolled and randomized.
725589|NCT01713933|B1|Baseline|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725590|NCT01713933|P1|Participant Flow|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725591|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725592|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725593|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725594|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725595|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725596|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725597|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725598|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725599|NCT01713933|O1|Outcome|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725600|NCT01713933|E1|Reported Event|Ultherapy® Treatment|Each enrolled subject will receive a bilateral Ultherapy® treatment of the upper arms
725601|NCT01713686|B1|Baseline|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725730|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
725602|NCT01713686|P1|Participant Flow|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725603|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725604|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725605|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725606|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725607|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725608|NCT01713686|O1|Outcome|Ulthera System Treatment|"A single triple-depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725850|NCT01712516|O4|Outcome|Placebo|b.i.d.
725851|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725609|NCT01713686|E1|Reported Event|Ulthera System Treatment|"A single triple depth Ulthera System treatment of the décolletage delivering treatment at 4.5mm, 3.0mm and 1.5mm depths.~Ulthera System Treatment: Focused ultrasound energy delivered below the surface of the skin"
725610|NCT01713660|B1|Baseline|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
725611|NCT01713660|P1|Participant Flow|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
725612|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
725613|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
725614|NCT01713660|O1|Outcome|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
725615|NCT01713660|E1|Reported Event|FS Corneal Incisions|iFS Femtosecond Laser : corneal incisions created by the femtosecond laser
725616|NCT01713621|B3|Baseline|Total|Total of all reporting groups
725617|NCT01713621|B2|Baseline|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
725618|NCT01713621|B1|Baseline|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
725619|NCT01713621|P2|Participant Flow|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
725620|NCT01713621|P1|Participant Flow|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
725621|NCT01713621|O2|Outcome|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
725622|NCT01713621|O1|Outcome|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
725623|NCT01713621|E2|Reported Event|OZ439 500mg|Single dose of 500mg of OZ439 administered as an oral suspension
725624|NCT01713621|E1|Reported Event|OZ439 100mg|Single dose of 100mg of OZ439 administered as an oral suspension
725625|NCT01713608|B5|Baseline|Total|Total of all reporting groups
725626|NCT01713608|B4|Baseline|Placebo|Placebo to match OZ439 PIB for oral suspension
725627|NCT01713608|B3|Baseline|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
725628|NCT01713608|B2|Baseline|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
725629|NCT01713608|B1|Baseline|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
725630|NCT01713608|P4|Participant Flow|Placebo|Placebo to match OZ439 PIB for oral suspension
725631|NCT01713608|P3|Participant Flow|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
725632|NCT01713608|P2|Participant Flow|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
725633|NCT01713608|P1|Participant Flow|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
725634|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
725635|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
725636|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
725637|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
725638|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
725639|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
725640|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
725641|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
725642|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
725643|NCT01713608|O3|Outcome|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
725644|NCT01713608|O2|Outcome|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
725645|NCT01713608|O1|Outcome|OZ439 300mg|300mg OZ439 drinking solution administered once daily for 3 days with milk
725646|NCT01713608|E4|Reported Event|Placebo|Placebo to match OZ439 PIB for oral suspension
725647|NCT01713608|E3|Reported Event|OZ439 700mg|700mg OZ439 drinking solution administered once daily for 3 days with milk
725648|NCT01713608|E2|Reported Event|OZ439 600mg|600mg OZ439 drinking solution administered once daily for 3 days with milk
725651|NCT01713530|B2|Baseline|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725652|NCT01713530|B1|Baseline|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725653|NCT01713530|P2|Participant Flow|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725852|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725654|NCT01713530|P1|Participant Flow|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725655|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725656|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725657|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725658|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725659|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725660|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725661|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725698|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725662|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725663|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725664|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725853|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725665|NCT01713530|O2|Outcome|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725666|NCT01713530|O1|Outcome|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725667|NCT01713530|E2|Reported Event|IDeg OD+IAsp|"The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2−4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling.~The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1."
725668|NCT01713530|E1|Reported Event|IDegAsp BID|The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening).
725669|NCT01713400|B3|Baseline|Total|Total of all reporting groups
725670|NCT01713400|B2|Baseline|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725671|NCT01713400|B1|Baseline|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725672|NCT01713400|P2|Participant Flow|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725673|NCT01713400|P1|Participant Flow|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725674|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725675|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725676|NCT01713400|O2|Outcome|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
726243|NCT01711177|O2|Outcome|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
725677|NCT01713400|O1|Outcome|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725678|NCT01713400|E2|Reported Event|Placebo|Placebo, Tacrolimus, and Sirolimus. Placebo: Identical volume to that of ustekinumab. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725679|NCT01713400|E1|Reported Event|Ustekinumab|Ustekinumab, Tacrolimus and Sirolimus. Ustekinumab: 45 mg for adults who weight 100 kg or less; 90 mg for adults who weight greater than 100 kg. Tacrolimus: Level determined according to Blood and Marrow Transplant (BMT) Program standard operating procedures. Sirolimus: The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program.
725680|NCT01713348|B5|Baseline|Total|Total of all reporting groups
725681|NCT01713348|B4|Baseline|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725854|NCT01712516|O4|Outcome|Placebo|b.i.d.
725855|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725682|NCT01713348|B3|Baseline|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725683|NCT01713348|B2|Baseline|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725684|NCT01713348|B1|Baseline|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725685|NCT01713348|P4|Participant Flow|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725686|NCT01713348|P3|Participant Flow|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725687|NCT01713348|P2|Participant Flow|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725688|NCT01713348|P1|Participant Flow|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725689|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725690|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725691|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725692|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725693|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725694|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725695|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725696|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725697|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725728|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
725699|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725700|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725701|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725702|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725703|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725704|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725705|NCT01713348|O4|Outcome|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725706|NCT01713348|O3|Outcome|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725707|NCT01713348|O2|Outcome|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100"
725708|NCT01713348|O1|Outcome|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725709|NCT01713348|E4|Reported Event|SMBG - Control Arm - Type 2 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
725710|NCT01713348|E3|Reported Event|CGM - Intervention Arm - Type 2 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725711|NCT01713348|E2|Reported Event|SMBG - Control Arm - Type 1 Diabetes|"Following a 14 day masked ( baseline) period using the FreeStyle Navigator subjects will manage their blood glucose with a standard SMBG and use a FreeStyle Navigator masked for a 14 day period at the end of the study.~Standard SMBG: Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100."
725712|NCT01713348|E1|Reported Event|CGM - Intervention Arm - Type 1 Diabetes|"Following a 14 day masked (baseline) period using the FreeStyle Navigator subjects will wear an unmasked FreeStyle Navigator with the glucose alarms switched off.~FreeStyle Navigator: Masked CGM day 1 to 15, unmasked CGM days 15 to 100"
725713|NCT01713283|B5|Baseline|Total|Total of all reporting groups
725714|NCT01713283|B4|Baseline|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
725715|NCT01713283|B3|Baseline|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
725716|NCT01713283|B2|Baseline|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced (TE))
725717|NCT01713283|B1|Baseline|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN))
725718|NCT01713283|P2|Participant Flow|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
725719|NCT01713283|P1|Participant Flow|SOF+RBV 12 Wk|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks
725720|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
725721|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
725722|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
725723|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
725724|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
725725|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
725726|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
725727|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
725731|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
725732|NCT01713283|O2|Outcome|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
725733|NCT01713283|O1|Outcome|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
725734|NCT01713283|O4|Outcome|SOF+RBV 24 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced)
725735|NCT01713283|O3|Outcome|SOF+RBV 24 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive)
725736|NCT01713283|O2|Outcome|SOF+RBV 12 Wk TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment experienced)
725737|NCT01713283|O1|Outcome|SOF+RBV 12 Wk TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive)
725738|NCT01713283|E2|Reported Event|SOF+RBV 24 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks
725739|NCT01713283|E1|Reported Event|SOF+RBV 12 Wk|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks
725763|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725740|NCT01713036|B1|Baseline|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
725741|NCT01713036|P1|Participant Flow|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [mcgCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
725742|NCT01713036|O1|Outcome|Pimasertib|Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [μCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
725743|NCT01713036|O1|Outcome|Pimasertib|Part B : Subjects received 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
725744|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725745|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725746|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
725747|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
725748|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
725749|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
725750|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
725751|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of metabolites, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
725752|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725753|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725754|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725755|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725756|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
726244|NCT01711177|O1|Outcome|Normal Control|"Normal patient placebo~placebo: Placebo"
725757|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725758|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725759|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725760|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725761|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725762|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725764|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725765|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725766|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725767|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725768|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725769|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects received 60 mg unlabeled Pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] Pimasertib orally on Day 8.
725770|NCT01713036|O1|Outcome|Pimasertib|Part A: For assessment of mass balance, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 mcgCi) of [14C] pimasertib orally on Day 8.
725771|NCT01713036|O1|Outcome|Pimasertib|Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725772|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725773|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725774|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725775|NCT01713036|O1|Outcome|Pimasertib|Part A: subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection.
725776|NCT01713036|E1|Reported Event|Pimasertib|"Part A: Subjects were administered with unlabeled pimasertib capsules orally at a single dose of 60 mg on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the IV tracer dose of 9 kBq [14C] pimasertib was administered as a bolus injection. On Days 3-21 (except Day 8), subjects received unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects received 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 MBq (70 μCi) of [14C] pimasertib orally. In the evening of Day 8, subjects received the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally.~Part B: Subjects were administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death."
725777|NCT01712984|B4|Baseline|Total|Total of all reporting groups
725778|NCT01712984|B3|Baseline|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725779|NCT01712984|B2|Baseline|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725780|NCT01712984|B1|Baseline|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725781|NCT01712984|P3|Participant Flow|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725782|NCT01712984|P2|Participant Flow|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725783|NCT01712984|P1|Participant Flow|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725784|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725785|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725786|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725787|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725788|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725789|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725790|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725791|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725856|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725793|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725794|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725795|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725796|NCT01712984|O3|Outcome|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725797|NCT01712984|O2|Outcome|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725798|NCT01712984|O1|Outcome|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725799|NCT01712984|E3|Reported Event|TIV ID2 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the alternate (Victoria) lineage (TIV ID2)
725800|NCT01712984|E2|Reported Event|TIV ID1 Vaccine Group|Adults 18 to <65 years of age received a single injection of trivalent influenza vaccine containing the B strain from the primary (Yamagata) lineage (TIV ID1)
725801|NCT01712984|E1|Reported Event|QIV ID Vaccine Group|Adults 18 to <65 years of age received a single injection of quadrivalent influenza intradermal (QIV ID) vaccine
725802|NCT01712854|B1|Baseline|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
725803|NCT01712854|P1|Participant Flow|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
725804|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
725805|NCT01712854|O1|Outcome|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
725806|NCT01712854|E1|Reported Event|Active Medication or Placebo|Data per arm is not available. Columbia will never have access to this data.
725807|NCT01712776|B3|Baseline|Total|Total of all reporting groups
725808|NCT01712776|B2|Baseline|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
725809|NCT01712776|B1|Baseline|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
725810|NCT01712776|P2|Participant Flow|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
725811|NCT01712776|P1|Participant Flow|Placebo (Normal Saline, Nature&Apos;s Tears)|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
725812|NCT01712776|O2|Outcome|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
725813|NCT01712776|O1|Outcome|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
725814|NCT01712776|E2|Reported Event|Nature's Tears|"Application of sterile water stream (manufacturer above) for 4-10 seconds onto the venipuncture site.~Sterile water (Nature's Tears): Topical stream of sterile water ( Nature's Tears ) 4-10 seconds duration to skin."
725815|NCT01712776|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream )|"Application of Vapocoolant (Pain Ease Medium Stream) for 4-10 seconds onto venipuncture site.~Vapocoolant (Pain Ease): Topical stream 4-10 seconds duration to skin."
725816|NCT01712711|B3|Baseline|Total|Total of all reporting groups
725817|NCT01712711|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
725818|NCT01712711|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
725819|NCT01712711|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
725820|NCT01712711|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
725821|NCT01712711|O2|Outcome|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
725822|NCT01712711|O1|Outcome|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
725823|NCT01712711|E2|Reported Event|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
725824|NCT01712711|E1|Reported Event|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
725825|NCT01712685|B1|Baseline|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725857|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725858|NCT01712516|O4|Outcome|Placebo|b.i.d.
725859|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725860|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725826|NCT01712685|P1|Participant Flow|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725827|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725828|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725829|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725830|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725831|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725832|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725833|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725834|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725835|NCT01712685|O1|Outcome|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725905|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725836|NCT01712685|E1|Reported Event|Renal Cell Carcinoma|This is a single arm, phase II trial of a novel radiotracer that is being evaluated for use in patients with kidney cancer. This study is designed to evaluate the imaging characteristics of this drug for detecting specific types of kidney cancer. This is a single administration trial of a single dose of the drug (18F-VM4-037: Drug being tested for use in cancer imaging studies; it may help tumor tissue show up more clearly during scans.) followed by imaging to assess distribution of the drug in normal and tumor tissue.
725837|NCT01712516|B5|Baseline|Total|Total of all reporting groups
725838|NCT01712516|B4|Baseline|Placebo|b.i.d.
725839|NCT01712516|B3|Baseline|NVA237|12.5 ug b.i.d.
725840|NCT01712516|B2|Baseline|QAB149|27.5 ug b.i.d.
725841|NCT01712516|B1|Baseline|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725842|NCT01712516|P4|Participant Flow|Placebo|b.i.d.
725843|NCT01712516|P3|Participant Flow|NVA237|12.5 ug b.i.d.
725844|NCT01712516|P2|Participant Flow|QAB149|27.5 ug b.i.d.
725845|NCT01712516|P1|Participant Flow|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725846|NCT01712516|O4|Outcome|Placebo|b.i.d.
725847|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725848|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725849|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725861|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725862|NCT01712516|O4|Outcome|Placebo|b.i.d.
725863|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725864|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725865|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725866|NCT01712516|O4|Outcome|Placebo|b.i.d.
725867|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725868|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725869|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725870|NCT01712516|O4|Outcome|Placebo|b.i.d.
725871|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725872|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725873|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725874|NCT01712516|O4|Outcome|Placebo|b.i.d.
725875|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725876|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725877|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725878|NCT01712516|O4|Outcome|Placebo|b.i.d.
725879|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725880|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725881|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725882|NCT01712516|O4|Outcome|Placebo|b.i.d.
725883|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725884|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725885|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725886|NCT01712516|O4|Outcome|Placebo|b.i.d.
725887|NCT01712516|O3|Outcome|NVA237|12.5 ug b.i.d.
725888|NCT01712516|O2|Outcome|QAB149|27.5 ug b.i.d.
725889|NCT01712516|O1|Outcome|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725890|NCT01712516|E4|Reported Event|Placebo|b.i.d.
725891|NCT01712516|E3|Reported Event|NVA237|12.5 ug b.i.d.
725892|NCT01712516|E2|Reported Event|QAB149|27.5 ug b.i.d.
725893|NCT01712516|E1|Reported Event|QVA149|27.5/12.5 ug twice daily (b.i.d.) via Single Dose Dry Powder Inhaler (SDDPI)
725894|NCT01712399|B1|Baseline|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725895|NCT01712399|P1|Participant Flow|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725896|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725897|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725898|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725899|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725900|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725901|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725902|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725903|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725904|NCT01712399|O1|Outcome|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725906|NCT01712399|E1|Reported Event|Mavrilimumab 100 mg|Participants received 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years.
725907|NCT01712360|B5|Baseline|Total|Total of all reporting groups
725908|NCT01712360|B4|Baseline|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
725909|NCT01712360|B3|Baseline|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725910|NCT01712360|B2|Baseline|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
725911|NCT01712360|B1|Baseline|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725912|NCT01712360|P4|Participant Flow|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
725913|NCT01712360|P3|Participant Flow|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725914|NCT01712360|P2|Participant Flow|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
725915|NCT01712360|P1|Participant Flow|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725916|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
725917|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
725918|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725919|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725920|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725921|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725922|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
725923|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725924|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
725925|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725926|NCT01712360|O6|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
725927|NCT01712360|O5|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
725928|NCT01712360|O4|Outcome|NAFT500 (Adult, Groin)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725929|NCT01712360|O3|Outcome|NAFT500 (Pediatric, Groin)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725930|NCT01712360|O2|Outcome|NAFT500 (Adult, Foot)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725931|NCT01712360|O1|Outcome|NAFT500 (Pediatric, Foot)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725932|NCT01712360|O4|Outcome|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
725933|NCT01712360|O3|Outcome|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725934|NCT01712360|O2|Outcome|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
725935|NCT01712360|O1|Outcome|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725936|NCT01712360|E4|Reported Event|NAFT600 (Adult)|"Topical once a day for two weeks~NAFT600 (adult): Applied to both feet"
725937|NCT01712360|E3|Reported Event|NAFT500 (Adult)|"Topical once a day for two weeks~NAFT500 (adult): Applied to both feet and groin area"
725938|NCT01712360|E2|Reported Event|NAFT600 (Pediatric)|"Topical once a day for two weeks~NAFT600 (pediatric): Applied to both feet only"
725939|NCT01712360|E1|Reported Event|NAFT500 (Pediatric)|"Topical once a day for two weeks~NAFT500 (pediatric): Applied to both feet and groin area"
725940|NCT01712334|B1|Baseline|All Participants|All participants received dornase alfa (Pulmozyme) inhaled once daily by the Pari eRapid nebulizer or the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then crossed over to use the other nebulizer in Treatment Period 2 for 2 weeks.
725941|NCT01712334|P2|Participant Flow|Jet Nebulizer Then eRapid Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 2.
725942|NCT01712334|P1|Participant Flow|eRapid Nebulizer Then Jet Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks in Treatment Period 1 then Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks in Treatment Period 2.
725943|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
725944|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
725945|NCT01712334|O2|Outcome|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
725946|NCT01712334|O1|Outcome|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
725947|NCT01712334|E2|Reported Event|Jet Nebulizer|Pulmozyme® inhaled once daily by the Pari LC Plus jet nebulizer for 2 weeks.
725948|NCT01712334|E1|Reported Event|eRapid Nebulizer|Dornase alfa (Pulmozyme®) inhaled once daily by the Pari eRapid nebulizer for 2 weeks.
725949|NCT01712256|B1|Baseline|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725950|NCT01712256|P1|Participant Flow|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
727780|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
725951|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725952|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725953|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725954|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725955|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725956|NCT01712256|O1|Outcome|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725957|NCT01712256|E1|Reported Event|Re-boosting With Vacc-4x|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) at day 1 and day 15.~Vacc-4x: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water."
725958|NCT01712204|B3|Baseline|Total|Total of all reporting groups
725959|NCT01712204|B2|Baseline|AC-201 50mg Capsule BID|AC-201 50mg Capsule BID for 16 Weeks
725960|NCT01712204|B1|Baseline|Placebo Capsule BID|Placebo Capsule BID for 16 Weeks
725961|NCT01712204|P2|Participant Flow|AC-201|AC-201 50mg Capsule BID for 16 Weeks
725962|NCT01712204|P1|Participant Flow|Placebo|Placebo Capsule BID for 16 Weeks
725963|NCT01712204|O2|Outcome|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
725964|NCT01712204|O1|Outcome|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
725965|NCT01712204|E2|Reported Event|AC-201|"AC-201 50mg Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
725966|NCT01712204|E1|Reported Event|Placebo|"Placebo Capsule BID for 16 Weeks~Background therapy: Urate-Lowering Therapy (Febuxostat 80 mg QD)"
725967|NCT01712178|B3|Baseline|Total|Total of all reporting groups
725968|NCT01712178|B2|Baseline|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725969|NCT01712178|B1|Baseline|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725970|NCT01712178|P2|Participant Flow|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725971|NCT01712178|P1|Participant Flow|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725972|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725973|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725974|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725975|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725976|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725977|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725978|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725979|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725980|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725981|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725982|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725983|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725984|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725985|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725986|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725987|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725988|NCT01712178|O2|Outcome|Current Formulation Adalimumab 40 mg Every Other Week|"Current formulation adalimumab 40 mg every other week~Adalimumab, current formulation: Current formulation adalimumab 40 mg every other week"
725989|NCT01712178|O1|Outcome|New Formulation of Adalimumab 40 mg Every Other Week|"New formulation adalimumab 40 mg every other week~Adalimumab, new formulation: New formulation adalimumab 40 mg every other week"
725990|NCT01712178|E2|Reported Event|Current Formulation Adalimumab 40 mg Every Other Week|
725991|NCT01712178|E1|Reported Event|New Formulation of Adalimumab 40 mg Every Other Week|
725992|NCT01712074|B4|Baseline|Total|Total of all reporting groups
725993|NCT01712074|B3|Baseline|Placebo: Double Blind Period|All participants entered the double blind period and received placebo
725994|NCT01712074|B2|Baseline|PF-05212377 30 mg: Double Blind Period|All participants entered the double blind period and received PF-05212377 30 mg
725995|NCT01712074|B1|Baseline|Not Randomized|Participants who have been discontinued during the Placebo Run-In period
725996|NCT01712074|P3|Participant Flow|Placebo: Double Blind Period|All participants that received placebo during the 12-week double blind period
725997|NCT01712074|P2|Participant Flow|PF-05212377 30 mg: Double Blind Period|All participants that received PF-05212377 30 mg during the 12-week double blind period
725998|NCT01712074|P1|Participant Flow|Placebo Run-In|Participants that received placebo during the 4-week single blind placebo run-in period
725999|NCT01712074|O3|Outcome|Placebo|All participants received placebo during double blind period
726000|NCT01712074|O2|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726001|NCT01712074|O1|Outcome|Placebo Run-in|All participants assigned to the placebo run-in period
726003|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726004|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
726005|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726006|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
726007|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726008|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
726009|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726010|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
726011|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726012|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
726013|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726014|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing vital signs data during double blind period
726015|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726016|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726017|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726018|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726019|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726020|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726021|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726022|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726023|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726024|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726025|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726026|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726027|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726028|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726029|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726030|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726031|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726032|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
727781|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
726033|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726034|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726035|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726036|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing ECG data during double blind period
726037|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726038|NCT01712074|O2|Outcome|Placebo|All participants who received placebo with non-missing ECG data during the double blind period
726039|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726040|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo with non-missing clinical laboratory data during double blind period
726041|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726042|NCT01712074|O2|Outcome|Placebo|All participants receiving placebo during double blind period
726043|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726044|NCT01712074|O2|Outcome|Placebo|All participants who received placebo contributing to the analysis during the double blind period
726045|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726046|NCT01712074|O2|Outcome|Placebo|All participants who received placebo contributing to the analysis during the double blind period
726047|NCT01712074|O1|Outcome|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726048|NCT01712074|E3|Reported Event|Placebo|All participants receiving placebo during double blind period
726049|NCT01712074|E2|Reported Event|PF-05212377 30 mg|participants who received PF-05212377 30 mg contributing to the analysis during double blind period
726050|NCT01712074|E1|Reported Event|Placebo Run-In|Participants received placebo during the single blind placebo run-in period
726051|NCT01712061|B3|Baseline|Total|Total of all reporting groups
726052|NCT01712061|B2|Baseline|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726053|NCT01712061|B1|Baseline|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726054|NCT01712061|P3|Participant Flow|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726055|NCT01712061|P2|Participant Flow|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
726056|NCT01712061|P1|Participant Flow|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
726057|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726058|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726059|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726060|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726061|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726062|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726063|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726064|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726065|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726066|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726067|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726068|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726069|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726070|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726071|NCT01712061|O2|Outcome|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
726072|NCT01712061|O1|Outcome|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
726073|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726074|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726075|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726076|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726077|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726078|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726080|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726081|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726082|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726083|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726084|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726085|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726086|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726087|NCT01712061|O2|Outcome|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726088|NCT01712061|O1|Outcome|PF-04634817 200 mg/150 mg|Participants were dosed orally at 150 mg (eGFR 20-<30 mL/min/1.73 m^2) or 200 mg (30-75 mL/min/1.73 m^2) QD for 12 weeks.
726089|NCT01712061|E3|Reported Event|Placebo|Participants were dosed orally with matching placebo tablets QD for 12 weeks.
726090|NCT01712061|E2|Reported Event|PF-04634817 200 mg|Participants with eGFR values of 30 to 75 mL/min/1.73 m^2 were dosed orally at 200 mg QD for 12 weeks.
726091|NCT01712061|E1|Reported Event|PF-04634817 150 mg|Participants with estimated glomerular filtration rate (eGFR) values of 20 to less than (<)30 milliliters/minute (mL/min)/1.73 square meter (m^2) were dosed orally at 150 mg once daily (QD) for 12 weeks.
726092|NCT01712009|B4|Baseline|Total|Total of all reporting groups
726093|NCT01712009|B3|Baseline|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726125|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726094|NCT01712009|B2|Baseline|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726095|NCT01712009|B1|Baseline|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726096|NCT01712009|P3|Participant Flow|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726097|NCT01712009|P2|Participant Flow|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726098|NCT01712009|P1|Participant Flow|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726099|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726100|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726101|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726102|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726103|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726104|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726105|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726106|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726107|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726108|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726109|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726110|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726111|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726112|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726113|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726114|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726115|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726116|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726117|NCT01712009|O3|Outcome|Loratadine 10 mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726118|NCT01712009|O2|Outcome|Naproxen 500 mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726119|NCT01712009|O1|Outcome|No Prophylaxis|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726120|NCT01712009|E3|Reported Event|Loratadine 10mg QD|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic loratadine 10 mg once a day (QD) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726121|NCT01712009|E2|Reported Event|Naproxen 500mg BID|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim in addition to prophylactic naproxen 500 mg orally twice a day (BID) for 5 days in each of the 4 cycles, beginning on the day of pegfilgrastim administration.
726122|NCT01712009|E1|Reported Event|No Prophylactic Intervention|Participants received adjuvant or neoadjuvant chemotherapy and pegfilgrastim.
726123|NCT01711918|B1|Baseline|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726124|NCT01711918|P1|Participant Flow|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726405|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726126|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726127|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726128|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726129|NCT01711918|O1|Outcome|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726130|NCT01711918|E1|Reported Event|Domperidone|"Participants will received domperidone at a dose of 10mg given up to three times per day~Domperidone: oral tablet; dose is 10mg per tablet given up to 3 times daily."
726131|NCT01711866|B1|Baseline|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
726132|NCT01711866|P1|Participant Flow|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
726133|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
726134|NCT01711866|O1|Outcome|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
726156|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
727782|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
726135|NCT01711866|E1|Reported Event|Rotigotine|"First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.~Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.~Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.~Rotigotine: Rotigotine up to 16 mg / 24 hours, 4 weeks."
726136|NCT01711853|B1|Baseline|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
726137|NCT01711853|P1|Participant Flow|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
726138|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
726139|NCT01711853|O1|Outcome|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
726140|NCT01711853|E1|Reported Event|Dabigatran 75 mg|Oral administration of 1 capsule of Dabigatran etexilate 75 mg twice daily
726141|NCT01711736|B3|Baseline|Total|Total of all reporting groups
726142|NCT01711736|B2|Baseline|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726143|NCT01711736|B1|Baseline|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726406|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726144|NCT01711736|P2|Participant Flow|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726145|NCT01711736|P1|Participant Flow|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726146|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726147|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726148|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726149|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726150|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726151|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726152|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726153|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726154|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726155|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726177|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726157|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726158|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726159|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726160|NCT01711736|O1|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726161|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726162|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726163|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726164|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726165|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726166|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726167|NCT01711736|O2|Outcome|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726168|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726169|NCT01711736|O1|Outcome|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726170|NCT01711736|E2|Reported Event|Fluarix Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of Fluarix vaccine.~Fluarix vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726171|NCT01711736|E1|Reported Event|GSK2282512A Group|"Subjects aged between 6 to 35 months inclusive received 1 dose (primed subjects) at Day 0 and 2 doses (unprimed subjects) at Days 0 and 28 of quadrivalent influenza GSK2282512A vaccine.~Quadrivalent influenza GSK2282512A vaccine was administered intramuscularly in the left anterolateral thigh (subjects < 12 months of age) or the deltoid muscle (subjects ≥ 12 months of age)."
726172|NCT01711645|B1|Baseline|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726173|NCT01711645|P1|Participant Flow|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726174|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726175|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726176|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
727783|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
726178|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726179|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726180|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726181|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726182|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726183|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726184|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726185|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726407|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726186|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726187|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726188|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726189|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726190|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726191|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726192|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726193|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726194|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726195|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726196|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726197|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726198|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726199|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726200|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726201|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726202|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726203|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726204|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726205|NCT01711645|O1|Outcome|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726206|NCT01711645|E1|Reported Event|Adacel® Tdap Vaccine|Postpartum participants receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed) as a single intramuscular (IM) 0.5 mL dose
726207|NCT01711424|B1|Baseline|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
726208|NCT01711424|P1|Participant Flow|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
726209|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
726210|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
726211|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
726212|NCT01711424|O1|Outcome|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
726213|NCT01711424|E1|Reported Event|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
726214|NCT01711216|B1|Baseline|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726215|NCT01711216|P1|Participant Flow|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726408|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726216|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726217|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726218|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726219|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726220|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726221|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726222|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726223|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726224|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726225|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726226|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726227|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726228|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726229|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726230|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726231|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726232|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726233|NCT01711216|O1|Outcome|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726234|NCT01711216|E1|Reported Event|Women Received Dydrogesterone for Irregular Menstrual Cycle|Adult women received dydrogesterone for irregular menstrual cycle as per standard clinical practice of the treating physician
726235|NCT01711177|B4|Baseline|Total|Total of all reporting groups
726236|NCT01711177|B3|Baseline|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
726237|NCT01711177|B2|Baseline|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
726238|NCT01711177|B1|Baseline|Normal Control|"Normal patient placebo~placebo: Placebo"
726239|NCT01711177|P3|Participant Flow|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
726240|NCT01711177|P2|Participant Flow|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
726241|NCT01711177|P1|Participant Flow|Normal Control|"Normal patient placebo~placebo: Placebo"
726242|NCT01711177|O3|Outcome|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
726245|NCT01711177|E3|Reported Event|Newly Diagnosed Glaucoma|"Treated with Travoprost (0.04%)~travoprost: Travatan Z is administered to newly diagnosed glaucoma patient"
726246|NCT01711177|E2|Reported Event|Glaucoma Suspect|"Patients with elevated Intraocular pressure higher than 18 mmHg (placebo)~placebo: Placebo"
726247|NCT01711177|E1|Reported Event|Normal Control|"Normal patient placebo~placebo: Placebo"
726248|NCT01710839|B3|Baseline|Total|Total of all reporting groups
726249|NCT01710839|B2|Baseline|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726250|NCT01710839|B1|Baseline|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726409|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726410|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726251|NCT01710839|P2|Participant Flow|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726252|NCT01710839|P1|Participant Flow|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726253|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726254|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726255|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726256|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726257|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726258|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726259|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726278|NCT01710657|P2|Participant Flow|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726260|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726261|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726283|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726411|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726262|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726263|NCT01710839|O2|Outcome|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726264|NCT01710839|O1|Outcome|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726265|NCT01710839|E2|Reported Event|Ranibizumab 0.5mg|"Cohort 2 (n=6), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses followed by PRN monthly treatment with ranibizumab 0.5 mg.~0.5mg Ranibizumab: intravitreal injections"
726266|NCT01710839|E1|Reported Event|Targeted Pan Retinal Laser Combined With 0.5mg Ranibizumab|"Cohort 1 (n=24), previously treated with at least 2 consecutive or more intravitreal injections of any anti-VEGF agent with persistent or recurrent macular edema will receive 6 loading doses of 0.5 mg ranibizumab followed by PRN treatment with ranibizumab 0.5 mg; after receiving the first loading dose of ranibizumab, the subject will have peripheral targeted-retinal photocoagulation (TRP) based on 200° wide field angiography with possibility of a second session of TRP at M4/M7, if non-perfusion persists based on angiogram.The 200°wide field angiography will indicate areas of peripheral ischemia which will be selectively treated, preserving areas of more perfused retina.~0.5mg Ranibizumab: intravitreal injections~Targeted Pan Retinal Photocoagulation: Targeted Pan Retinal Photocoagulation based on wide field angiography"
726267|NCT01710800|B1|Baseline|All Study Participants|Patients will be randomized to receive either PPI or placebo (sequence 1) and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes. Sequence 2 (placebo or PPI) will be administered followed by repeat 24 hour pH with impedance.
726268|NCT01710800|P1|Participant Flow|First Intervention (7 Days), Second Intervention (7 Days)|Patients will be randomized to receive either PPI or placebo (sequence 1) for 7 days and then undergo a 24 hour pH study with impedance to measure the number of reflux episode. The second sequence of medications (that is either placebo or PPI or sequence 2) will be administered followed by repeat 24 hour pH with impedance 7 days later.
726269|NCT01710800|O2|Outcome|Esomeprazole|Patients were randomly assigned to receive 40 mg esomeprazole twice daily prior to undergoing a 24 hour pH study with impedance to measure the number of reflux episodes
726270|NCT01710800|O1|Outcome|Placebo Arm|Patients will be randomized to receive either PPI or placebo and then undergo a 24 hour pH study with impedance to measure the number of reflux episodes
726271|NCT01710800|E2|Reported Event|PPI Arm|
726272|NCT01710800|E1|Reported Event|Placebo Arm|
726273|NCT01710657|B4|Baseline|Total|Total of all reporting groups
726274|NCT01710657|B3|Baseline|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726275|NCT01710657|B2|Baseline|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726276|NCT01710657|B1|Baseline|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
726277|NCT01710657|P3|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726279|NCT01710657|P1|Participant Flow|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
726280|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726281|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726282|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
726412|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726413|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726284|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726285|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
726286|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726287|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726288|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
726289|NCT01710657|O3|Outcome|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726290|NCT01710657|O2|Outcome|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726291|NCT01710657|O1|Outcome|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
726292|NCT01710657|E3|Reported Event|Lacosamide 400 mg/Day|"Lacosamide Treatment of 400 mg/day (200 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726293|NCT01710657|E2|Reported Event|Lacosamide 200 mg/Day|"Lacosamide Treatment of 200 mg/day (100 mg bid) for 16 weeks.~Lacosamide 50 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 50 mg~Route of Administration: Oral use~Lacosamide 100 mg: - Active Substance: Lacosamide~Pharmaceutical Form: Film-coated tablet~Concentration: 100 mg~Route of Administration: Oral use"
726294|NCT01710657|E1|Reported Event|Placebo|"Matching Placebo for 16 weeks.~Placebo: Matching oral Placebo tablets twice daily for 16 weeks."
726295|NCT01710527|B1|Baseline|Treatment T-Metformin 500 mg + Treatment R-Glucophage 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet) or treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726296|NCT01710527|P2|Participant Flow|Treatment R-Glucophage 500mg, Then Treatment T-Metformin 500mg|Participants received one tablet of treatment R (Glucophage 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment T (Metformin 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period.
726297|NCT01710527|P1|Participant Flow|Treatment T-Metformin 500mg, Then Treatment R-Glucophage 500mg|Participants received one tablet of treatment T (Metformin 500 mg tablet) given with 250 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 minutes (min) for up to 4 hours after dosing according to a plan of randomization. After a washout period of 7 days, participants then received one tablet of treatment R (Glucophage 500 mg tablet) given with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 ante meridiem (am) and 8:30 am on Day 1 (dosing day) of each study period.
726298|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726351|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726414|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726299|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726300|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726301|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726302|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726303|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726304|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726305|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726306|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726347|NCT01710501|P1|Participant Flow|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726307|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726308|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726309|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726310|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726311|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726312|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726313|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726314|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726315|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726348|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726316|NCT01710527|O2|Outcome|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726317|NCT01710527|O1|Outcome|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 hours after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 hours of overnight fasting, and confined until collecting 24 hour post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726318|NCT01710527|E2|Reported Event|Treatment R- Glucophage 500 mg|In each period of the study, participants received one tablet of treatment R (Glucophage 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726319|NCT01710527|E1|Reported Event|Treatment T-Metformin 500 mg|In each period of the study, participants received one tablet of treatment T (Metformin 500 mg tablet), with 240 mL of 20% glucose solution in water followed by 60 mL of the glucose solution administered every 15 min for up to 4 h after dosing either in sequence of treatment T/R or treatment R/T according to a plan of randomization. Participants were admitted the night before study drug administration, supervised for at least 10 h of overnight fasting, and confined until collecting 24 h post-dose blood sample during study drug administration of each period. The study drug administration took place between 8:00 am and 8:30 am on Day 1 (dosing day) of each study period. The two treatment periods were separated by a washout period of 7 days.
726320|NCT01710514|B3|Baseline|Total|Total of all reporting groups
726321|NCT01710514|B2|Baseline|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
726322|NCT01710514|B1|Baseline|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
726323|NCT01710514|P2|Participant Flow|FE 999913 100 mg TID|"FE 999913 100 mg vaginal tablet TID~FE 999913 vaginal tablet"
726324|NCT01710514|P1|Participant Flow|FE 999913 100 mg BID|"FE 999913 100 mg vaginal tablet BID~FE 999913 vaginal tablet"
726325|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
726326|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
726327|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
726328|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
726329|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
726330|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
726331|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
726332|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
726333|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
726334|NCT01710514|O3|Outcome|FE 999913 Total|Data pooled from BID and TID groups
726335|NCT01710514|O2|Outcome|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
726336|NCT01710514|O1|Outcome|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
726337|NCT01710514|O1|Outcome|FE999913 000072 (BID/TID)|Data pooled from both BID and TID groups
726338|NCT01710514|E3|Reported Event|FE 999913 Total|Data pooled from BID and TID groups
726339|NCT01710514|E2|Reported Event|FE 999913 100 mg TID|FE 999913 100 mg vaginal tablet TID
726340|NCT01710514|E1|Reported Event|FE 999913 100 mg BID|FE 999913 100 mg vaginal tablet BID
726341|NCT01710501|B4|Baseline|Total|Total of all reporting groups
726342|NCT01710501|B3|Baseline|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726343|NCT01710501|B2|Baseline|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726344|NCT01710501|B1|Baseline|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726345|NCT01710501|P3|Participant Flow|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726346|NCT01710501|P2|Participant Flow|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
727784|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
726349|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726350|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726352|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726353|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726354|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726355|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726356|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726357|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726358|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726359|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726360|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726361|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726362|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726363|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726364|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726365|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726366|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726367|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726397|NCT01710332|E2|Reported Event|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
726368|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726369|NCT01710501|O3|Outcome|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726370|NCT01710501|O2|Outcome|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726371|NCT01710501|O1|Outcome|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726372|NCT01710501|E3|Reported Event|Grazoprevir 100 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 100 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726373|NCT01710501|E2|Reported Event|Grazoprevir 50 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 50 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726374|NCT01710501|E1|Reported Event|Grazoprevir 25 mg + PEG-IFN + RBV|After a maximum of a 45 day screening window, randomized participants received 25 mg grazoprevir in combination with PEG-IFN and RBV for 12 weeks followed by 24 weeks of follow-up as determined by RGT. Participants could receive an additional 12 weeks of PEG-IFN plus RBV depending on their HCV RNA level at TW 4.
726375|NCT01710345|B4|Baseline|Total|Total of all reporting groups
726376|NCT01710345|B3|Baseline|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
726377|NCT01710345|B2|Baseline|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
726378|NCT01710345|B1|Baseline|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
726379|NCT01710345|P3|Participant Flow|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
726380|NCT01710345|P2|Participant Flow|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
726381|NCT01710345|P1|Participant Flow|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
726382|NCT01710345|O3|Outcome|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
726383|NCT01710345|O2|Outcome|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
726384|NCT01710345|O1|Outcome|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
726385|NCT01710345|E3|Reported Event|Placebo NanoTab|Placebo NanoTab as needed every 60 minutes for 12 hours
726386|NCT01710345|E2|Reported Event|Sufentanil NanoTab 30 mcg|Sufentanil NanoTab 30 mcg as needed every 60 minutes for 12 hours
726387|NCT01710345|E1|Reported Event|Sufentanil NanoTab 20 mcg|Sufentanil NanoTab 20 mcg as needed every 60 minutes for 12 hours
726388|NCT01710332|B3|Baseline|Total|Total of all reporting groups
726389|NCT01710332|B2|Baseline|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
726390|NCT01710332|B1|Baseline|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
726391|NCT01710332|P2|Participant Flow|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
726392|NCT01710332|P1|Participant Flow|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
726393|NCT01710332|O2|Outcome|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
726394|NCT01710332|O1|Outcome|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
726395|NCT01710332|O2|Outcome|Intravitreal Aflibercept Injection (x6)|"2 mg / Intravitreal / every 1 month x 6 months ((Drug administered 6 times).~GROUP B – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
726396|NCT01710332|O1|Outcome|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
726540|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726398|NCT01710332|E1|Reported Event|Intravitreal Aflibercept Injection (x4)|"2 mg / Intravitreal / every 1 month x 3 months and at month 4 (Drug administered 4 times).~Intravitreal Aflibercept Injection: GROUP A – Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total)."
726399|NCT01710046|B3|Baseline|Total|Total of all reporting groups
726400|NCT01710046|B2|Baseline|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726401|NCT01710046|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726402|NCT01710046|P2|Participant Flow|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726403|NCT01710046|P1|Participant Flow|Tofacitinib 10 Milligrams (mg) Twice Daily (BID)|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726404|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726415|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726416|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726417|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726418|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726419|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726420|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726421|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726422|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726423|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726424|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726425|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726426|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726427|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726428|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726429|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726430|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726431|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726432|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726433|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726434|NCT01710046|O2|Outcome|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726435|NCT01710046|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726436|NCT01710046|E2|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID for 12 weeks.
726437|NCT01710046|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib tablets, 10 mg, orally, BID for 12 weeks.
726438|NCT01710033|B5|Baseline|Total|Total of all reporting groups
726439|NCT01710033|B4|Baseline|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726440|NCT01710033|B3|Baseline|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726441|NCT01710033|B2|Baseline|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726442|NCT01710033|B1|Baseline|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726443|NCT01710033|P5|Participant Flow|CP-690,550 30 mg, Stage 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 2.
726541|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726444|NCT01710033|P4|Participant Flow|CP-690,550 30 mg, Stage 1|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1.
726445|NCT01710033|P3|Participant Flow|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726446|NCT01710033|P2|Participant Flow|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726447|NCT01710033|P1|Participant Flow|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (mycophenolate mofetil [MMF] with or without calcineurin inhibitor [cyclosporine {CsA} or tacrolimus {TAC}]) as per local clinical practice in Stage 1.
726448|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726449|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726450|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
727814|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
726451|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726452|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726453|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726454|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726455|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726456|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726457|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726458|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726459|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726460|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726461|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726462|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726463|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726464|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726465|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
727785|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
726466|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726467|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726468|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726469|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726470|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726471|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726472|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726473|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726474|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726475|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726476|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726477|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726478|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726479|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726480|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726481|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726482|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726483|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726484|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726485|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726486|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726487|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726542|NCT01710020|E2|Reported Event|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
727786|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
726488|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726489|NCT01710033|O4|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726490|NCT01710033|O3|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726491|NCT01710033|O2|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726492|NCT01710033|O1|Outcome|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726493|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726494|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726495|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726496|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726497|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726498|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726499|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726500|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726501|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726502|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726503|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726504|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726505|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726506|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726507|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726508|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726509|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726510|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726511|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726512|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726513|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726514|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726515|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726516|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726517|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726604|NCT01709864|E2|Reported Event|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726518|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726519|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726520|NCT01710033|O3|Outcome|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726521|NCT01710033|O2|Outcome|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726522|NCT01710033|O1|Outcome|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726523|NCT01710033|E4|Reported Event|CP-690,550 30 mg, Stage 1 And 2|CP-690,550 30 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) as per local clinical practice in Stage 1 and 2.
726524|NCT01710033|E3|Reported Event|CP-690,550 15 mg, Stage 1|CP-690,550 15 mg tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726525|NCT01710033|E2|Reported Event|CP-690,550 5 mg, Stage 1|CP-690,550 5 milligram (mg) tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF), calcineurin inhibitor (CsA) as per local clinical practice in Stage 1.
726526|NCT01710033|E1|Reported Event|Placebo, Stage 1|Placebo matched to CP-690,550 tablet orally twice daily up to Day 28 followed by single oral dose on Day 29 in stable renal transplant recipients, receiving maintenance immunosuppression therapy (MMF) with or without calcineurin inhibitor (CsA or TAC) as per local clinical practice in Stage 1.
726527|NCT01710020|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
726528|NCT01710020|P1|Participant Flow|CP-690,550 (10 mg OPC)|Single oral dose of CP-690,550 10 milligram (mg) oral powder for constitution (OPC) 1 to 2 hours (hrs) post-hemodialysis in Period 1 followed by single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2. A washout period of at least 14 days was maintained between each intervention period.
726529|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
726530|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
726531|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726532|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
726533|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
726534|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
726535|NCT01710020|O1|Outcome|CP-690,550 (Period 2)|Single oral dose of CP-690,550 10 mg OPC approximately 4 hours prior to hemodialysis in Period 2.
726536|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726537|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726538|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726539|NCT01710020|O1|Outcome|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726543|NCT01710020|E1|Reported Event|CP-690,550 (Period 1)|Single oral dose of CP-690,550 10 mg OPC 1 to 2 hours post-hemodialysis in Period 1.
726544|NCT01709903|B3|Baseline|Total|Total of all reporting groups
726545|NCT01709903|B2|Baseline|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726546|NCT01709903|B1|Baseline|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726547|NCT01709903|P2|Participant Flow|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726548|NCT01709903|P1|Participant Flow|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726549|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726550|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726551|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726552|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726553|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726554|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726555|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726556|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726557|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726558|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726559|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726560|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726561|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726562|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726563|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726564|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726565|NCT01709903|O2|Outcome|Fluticasone/Salmeterol|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726566|NCT01709903|O1|Outcome|QVA149|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726567|NCT01709903|E2|Reported Event|Salmeterol/Fluticasone 50mcg/500mcg|Fluticasone/salmeterol 500/50 µg b.i.d., delivered via a dry powder inhaler Accuhaler® device
726568|NCT01709903|E1|Reported Event|QVA149 110mcg/50mcg|QVA149 110/50 µg o.d., delivered via a single-dose dry powder inhaler (SDDPI), consisting of a fixed dose combination of indacaterol 110µg and NVA237 50µg
726569|NCT01709864|B3|Baseline|Total|Total of all reporting groups
726570|NCT01709864|B2|Baseline|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726571|NCT01709864|B1|Baseline|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726572|NCT01709864|P2|Participant Flow|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726573|NCT01709864|P1|Participant Flow|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726574|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726575|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726576|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726577|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726578|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726579|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726580|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726581|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726582|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726583|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726584|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726585|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726586|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726587|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726588|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726589|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726590|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726591|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726592|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726593|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726594|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726595|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726596|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726597|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726598|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726599|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726600|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726601|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726602|NCT01709864|O2|Outcome|Placebo|Placebo will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks.
726603|NCT01709864|O1|Outcome|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
727815|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
726605|NCT01709864|E1|Reported Event|NVA237|NVA237 will be inhaled from a single-dose dry powder inhaler for a period of 12 weeks
726606|NCT01709799|B4|Baseline|Total|Total of all reporting groups
726607|NCT01709799|B3|Baseline|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726608|NCT01709799|B2|Baseline|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
726609|NCT01709799|B1|Baseline|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Participants also received cognitive training every fourth week. See Cognitive Training arm for description."
726610|NCT01709799|P3|Participant Flow|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726611|NCT01709799|P2|Participant Flow|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
726612|NCT01709799|P1|Participant Flow|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
726659|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726613|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726614|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726615|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726616|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726617|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726618|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726619|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726620|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726621|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726622|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726623|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726624|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726625|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726626|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726627|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726628|NCT01709799|O3|Outcome|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726629|NCT01709799|O2|Outcome|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726630|NCT01709799|O1|Outcome|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR. Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every 4th week, participants will add 80mins./day of Insight gaming for cognitive training (see Cognitive Training arm for details)"
726631|NCT01709799|E3|Reported Event|Cognitive Training|"Participants will complete 80 mins/day during the 4th, 8th, 12th and 16th weeks of the intervention.~Cognitive Training: Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
726657|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
727787|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
726632|NCT01709799|E2|Reported Event|Cognitive Training Plus Exergames|"Physical exercise in this group will be achieved using the Nintendo Wii Sports Resort and Wii Sports video games. A standardized gaming plan will be used for all participants, with play starting at 15 mins. and increasing 5 mins each week after, up to a maximum of 40 play minutes.~Exergames: Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
726633|NCT01709799|E1|Reported Event|Cognitive Training Plus Exercise|"Physical exercise will be achieved using traditional methods of aerobic exercise. Participants may choose between walking on a treadmill or riding on a stationary bike (Choices include recumbent or traditional sit-up bike.)~Exercise: Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data.~Every fourth week, participants will complete Cognitive Training. See Cognitive Training arm for details."
726634|NCT01709786|B1|Baseline|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
727816|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
726635|NCT01709786|P1|Participant Flow|Patients With Suspected Hemorrhage|There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
726636|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
726637|NCT01709786|O1|Outcome|iSTAT Hemoglobin|iSTAT hemoglobin measurement
726638|NCT01709786|O2|Outcome|CBC Hemoglobin|CBC hemoglobin measurement
726639|NCT01709786|O1|Outcome|Radical-7 Hemoglobin|Radical-7 hemoglobin measurement
726640|NCT01709786|E1|Reported Event|Radical-7 vs. CBC|All patients: Difference between Radical-Y hemoglobin measurement and CBC hemoglobin measurement
726641|NCT01709708|B3|Baseline|Total|Total of all reporting groups
726642|NCT01709708|B2|Baseline|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
726643|NCT01709708|B1|Baseline|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
726644|NCT01709708|P2|Participant Flow|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
726645|NCT01709708|P1|Participant Flow|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
726646|NCT01709708|O2|Outcome|Saline|Group B will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
726647|NCT01709708|O1|Outcome|Marcaine|"Group A will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
726648|NCT01709708|E2|Reported Event|Saline|Saline (Group B) will receive saline placebo delivered bilaterally with the Tx360TM device to the mucosa associated with the SPG.
726649|NCT01709708|E1|Reported Event|Marcaine|"Marcaine (Group A) will receive treatment with 0.3 mL of 0.5% Marcaine delivered bilaterally with the Tx360™ device to the mucosa associated with the Sphenopalatine Ganglion (SPG)~Marcaine: Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG."
726650|NCT01709513|B4|Baseline|Total|Total of all reporting groups
726651|NCT01709513|B3|Baseline|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726652|NCT01709513|B2|Baseline|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726653|NCT01709513|B1|Baseline|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable lipid-modifying therapy (LMT).
726654|NCT01709513|P3|Participant Flow|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726655|NCT01709513|P2|Participant Flow|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726656|NCT01709513|P1|Participant Flow|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally once daily (QD) for 24 weeks and placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) for 24 weeks added to stable LMT.
726658|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726660|NCT01709513|O3|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726661|NCT01709513|O2|Outcome|Ezetimibe (Active Comparator)|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726662|NCT01709513|O1|Outcome|Atorvastatin (Statin Rechallenge Arm)|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726663|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726664|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726665|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726666|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726967|NCT01708915|E3|Reported Event|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
726667|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726668|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726669|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726670|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726671|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726672|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726673|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726674|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726675|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726676|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726677|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726678|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726679|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726680|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726681|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726682|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726683|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726684|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726747|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726685|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726686|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726687|NCT01709513|O2|Outcome|Alirocumab 75/ up to 150|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726688|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726689|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726690|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726718|NCT01709500|P1|Participant Flow|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726691|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726692|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726693|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726694|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726695|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726696|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726697|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726698|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726699|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726700|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726701|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726702|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726703|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726704|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726705|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726706|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726707|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726708|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726709|NCT01709513|O2|Outcome|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 24 weeks and placebo (for atorvastatin/ezetimibe) over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726710|NCT01709513|O1|Outcome|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 24 weeks added to stable LMT.
726711|NCT01709513|E3|Reported Event|Alirocumab 75 mg/ up to 150 mg|Alirocumab 75 mg SC injection Q2W for 22 weeks and placebo for atorvastatin/ezetimibe over-encapsulated tablets orally QD for 24 weeks added to stable LMT. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-­C levels ≥70 mg/dL (1.81 mmol/L) or ≥100 mg/dL (2.59 mmol/L) at Week 8, based on cardiovascular risk.
726712|NCT01709513|E2|Reported Event|Ezetimibe|Ezetimibe 10 mg over-encapsulated tablets orally QD for 24 weeks and placebo for alirocumab SC injection Q2W for 22 weeks added to stable LMT.
726713|NCT01709513|E1|Reported Event|Atorvastatin|Atorvastatin 20 mg over-encapsulated tablets orally QD for 24 weeks and placebo (for alirocumab) SC injection Q2W for 22 weeks added to stable LMT.
726714|NCT01709500|B3|Baseline|Total|Total of all reporting groups
726715|NCT01709500|B2|Baseline|Placebo|Placebo matched to alirocumab SC injection for 78­-week treatment duration.
726716|NCT01709500|B1|Baseline|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726717|NCT01709500|P2|Participant Flow|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726719|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726720|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726721|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726722|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726723|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726724|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726725|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726726|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726727|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726728|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726729|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726730|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726731|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726732|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726733|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726734|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726735|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726736|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726737|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726738|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726739|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726740|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726741|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726742|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726743|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726744|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726745|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726746|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726748|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726749|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726750|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726751|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726752|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726753|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726754|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726755|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726756|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726757|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726758|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726759|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726760|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726761|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726762|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726763|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726764|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726765|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726766|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726767|NCT01709500|O2|Outcome|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726768|NCT01709500|O1|Outcome|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection Q2W added to stable dose of statin with or without LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726769|NCT01709500|E2|Reported Event|Placebo|Placebo matched to alirocumab SC injection for 78-week treatment duration.
726770|NCT01709500|E1|Reported Event|Alirocumab 75 mg/up to 150 mg|Alirocumab 75 mg SC injection every two weeks (Q2W) added to stable dose of statin with or without LMT for 76 weeks. Alirocumab dose up-titrated to 150 mg Q2W from Week 12 when LDL-C levels ≥70 mg/dL at Week 8.
726771|NCT01709474|B3|Baseline|Total|Total of all reporting groups
726772|NCT01709474|B2|Baseline|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
726773|NCT01709474|B1|Baseline|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
726774|NCT01709474|P2|Participant Flow|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
726775|NCT01709474|P1|Participant Flow|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
726776|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
726777|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
726778|NCT01709474|O2|Outcome|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
726779|NCT01709474|O1|Outcome|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
726780|NCT01709474|E2|Reported Event|Vitamin D3 400 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 400 international units [IU] daily).
726781|NCT01709474|E1|Reported Event|Vitamin D3 6000 IU|Participants received an 18-week course of oral Vitamin D3 (cholecalciferol, 6,000 international units [IU] daily).
726782|NCT01709422|B3|Baseline|Total|Total of all reporting groups
726783|NCT01709422|B2|Baseline|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
726784|NCT01709422|B1|Baseline|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
726785|NCT01709422|P2|Participant Flow|Conventional|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
726786|NCT01709422|P1|Participant Flow|Propofol|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
726787|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3minutes to maintain the desired level of sedation (moderate to deep sedation ) without maximum limit.
726788|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation (moderate to deep sedation ) without maximum limit
726789|NCT01709422|O2|Outcome|Midazolam and Meperidine|the initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes to maintain the desired level of sedation(moderate to deep sedation ) without maximum limit.
726790|NCT01709422|O1|Outcome|Propofol,Midazolam and Meperidine|the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg. The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second to maintained the desired level of sedation(moderate to deep sedation ) without maximum limit.
726968|NCT01708915|E2|Reported Event|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
726969|NCT01708915|E1|Reported Event|Placebo|Patients treated with placebo ointment
726791|NCT01709422|E2|Reported Event|Midazolam and Meperidine|The initial dose of midazolam and meperidine were 2-5 mg iv and 25-50 mg iv respectively then the midazolam dose was given 0.5-1.0 mg iv and meperidine dose was given 5-10 mg iv every 2-3 minutes
726792|NCT01709422|E1|Reported Event|Propofol,Midazolam and Meperidine|The propofol was given as initial bolus of 20 mg and then the dose was given 5-10 mg every 30-60 second.the dose of midazolam was 1 mg in patients below 70 years and 0.5 mg in patients ≥ 70 years and the dose of meperidine was fixed at 20 mg.
726793|NCT01709331|B1|Baseline|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
726794|NCT01709331|P1|Participant Flow|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly subcutaneous (SC) injections of human chorionic gonadotropin (hCG) 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
726795|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
726796|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
726797|NCT01709331|O1|Outcome|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
726798|NCT01709331|E1|Reported Event|Corifollitropin Alfa 150 μg + hCG|During a 16-week pretreatment phase, participants received twice-weekly SC injections of hCG 1500 or 3000 IU. Eligible participants were then enrolled in the combined treatment phase in which they received a single dose of corifollitropin alfa 150 μg by SC injection once every 2 weeks for 52 weeks. In addition, eligible participants continued to receive twice-weekly hCG injections on the same schedule begun during the pretreatment phase.
726799|NCT01709305|B1|Baseline|Overall Study|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20).
726800|NCT01709305|P5|Participant Flow|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combinatino therapy for 24 weeks (Week 20 through Week 44). There were 554 participants randomized to this arm in Phase 2.
726801|NCT01709305|P4|Participant Flow|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 556 participants randomized to this arm in Phase 2.
726802|NCT01709305|P3|Participant Flow|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants randomized to this arm in Phase 2.
726803|NCT01709305|P2|Participant Flow|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 552 participants randomized to this arm in Phase 2.
726804|NCT01709305|P1|Participant Flow|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin (Week 0 through Week 20). There were 5570 participants enrolled in Phase 1.
726805|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726948|NCT01708915|P2|Participant Flow|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
726806|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726807|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726808|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726809|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726810|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726811|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726812|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726813|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726814|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726815|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726816|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726817|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726818|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726819|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726820|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726821|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726822|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726823|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726824|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726825|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 550 participants that contributed to the week 44 analysis.
726826|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 551 participants that contributed to the week 44 analysis.
726827|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 502 participants that contributed to the week 44 analysis.
726828|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44). There were 501 participants that contributed to the week 44 analysis.
726829|NCT01709305|O4|Outcome|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726830|NCT01709305|O3|Outcome|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726831|NCT01709305|O2|Outcome|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metfomin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726832|NCT01709305|O1|Outcome|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726833|NCT01709305|E5|Reported Event|Phase 2: Metformin + Sitagliptin + Glimepiride|During Phase 2, participants received up to 6 mg glimepiride daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726834|NCT01709305|E4|Reported Event|Phase 2: Metformin + Sitagliptin + Gliclazide|During Phase 2, participants received 30-120 mg gliclazide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726835|NCT01709305|E3|Reported Event|Phase 2: Metformin + Sitagliptin + Repaglinide|During Phase 2, participants received up to 16 mg repaglinide daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726836|NCT01709305|E2|Reported Event|Phase 2: Metformin + Sitagliptin + Acarbose|During Phase 2, participants received 50-100 mg acarbose three times daily as an add-on to metformin + sitagliptin combination therapy for 24 weeks (Week 20 through Week 44).
726837|NCT01709305|E1|Reported Event|Phase 1: Sitagliptin + Metformin|During Phase 1, participants received sitagliptin 100 mg + metformin for 20 weeks (Week 0 through Week 20).
726838|NCT01709227|B3|Baseline|Total|Total of all reporting groups
726839|NCT01709227|B2|Baseline|Peritoneal Dialysis|Patients randomized to receive peritoneal dialysis
726840|NCT01709227|B1|Baseline|Furosemide|Patients randomized to receive furosemide
726880|NCT01709136|B1|Baseline|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
726841|NCT01709227|P2|Participant Flow|Peritoneal Dialysis|"Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management will be directed by CICU attending and Nephrology service~Peritoneal Dialysis: Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.~One potential outcome during use of a peritoneal dialysis catheter is the development of a Pleural Peritoneal communication. In this event, dialysis fluid is instilled in the peritoneum and then leaks into the pleural space through a defect in the diaphragm. This fluid is then drained out of a surgical chest tube. This impairs the ability to perform peritoneal dialysis and thus is a reason to not complete the randomized arm."
726842|NCT01709227|P1|Participant Flow|Furosemide|"Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.~Furosemide: Patients randomized to the furosemide arm are given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix"
726843|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to PD
726844|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726845|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726846|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726847|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726848|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726849|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726850|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726851|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726852|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726853|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726854|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726855|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726856|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726857|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to PD
726858|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726859|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726860|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726861|NCT01709227|O2|Outcome|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726862|NCT01709227|O1|Outcome|Furosemide|Patients randomized to furosemide
726863|NCT01709227|E2|Reported Event|Peritoneal Dialysis|Patients randomized to peritoneal dialysis
726864|NCT01709227|E1|Reported Event|Furosemide|Patients randomized to furosemide
726865|NCT01709162|B3|Baseline|Total|Total of all reporting groups
726866|NCT01709162|B2|Baseline|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
726867|NCT01709162|B1|Baseline|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
726868|NCT01709162|P2|Participant Flow|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
726869|NCT01709162|P1|Participant Flow|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
726870|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
726871|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
726872|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
726873|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
726874|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
726949|NCT01708915|P1|Participant Flow|Placebo|Patients treated with placebo ointment
726875|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
726876|NCT01709162|O2|Outcome|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
726877|NCT01709162|O1|Outcome|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, intravenously by infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
726878|NCT01709162|E2|Reported Event|Chemotherapy|Participants received the investigator's choice of chemotherapy, dosed per package instructions.
726879|NCT01709162|E1|Reported Event|Ipilimumab, 3 mg/kg|Participants received ipilimumab, 3 mg/kg, by intravenous infusion every 3 weeks for a total of 4 doses or until disease progression, unacceptable toxicity, or withdrawal of consent
726966|NCT01708915|E4|Reported Event|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide alone
726881|NCT01709136|P1|Participant Flow|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the Children's Hospital of Pittsburgh Pediatric Clinical and Translational Research Center (PCTRC) - See more at: http://www.chp.edu/research/our-facilities/pctrc, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate Glomerular Filtration Rate (GFR) evaluation, or a few days later at the convenience of the subject.
726882|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
726883|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
726884|NCT01709136|O1|Outcome|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab..
726885|NCT01709136|O1|Outcome|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab.
726886|NCT01709136|E1|Reported Event|Sirolimus|Sirolimus: Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the PCTRC , and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
726887|NCT01709084|B3|Baseline|Total|Total of all reporting groups
726888|NCT01709084|B2|Baseline|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726889|NCT01709084|B1|Baseline|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726890|NCT01709084|P2|Participant Flow|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726891|NCT01709084|P1|Participant Flow|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726892|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726893|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726894|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726895|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726896|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726950|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
726897|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726898|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726899|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726900|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726901|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726902|NCT01709084|O2|Outcome|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726903|NCT01709084|O1|Outcome|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726904|NCT01709084|E2|Reported Event|TDF/FTC/EFV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 600 mg Efavirenz (EFV) on an empty stomach at bedtime, until Week 48.
726905|NCT01709084|E1|Reported Event|TDF/FTC/RPV|Participants received Film-coated fixed dose combination (FDC) tablet containing 300 milligram (mg) Tenofovir disoproxil fumarate (TDF), 200 mg Emtricitabine (FTC) and 25 mg Rilpivirine (RPV) with a meal, until Week 48.
726906|NCT01708967|B3|Baseline|Total|Total of all reporting groups
726907|NCT01708967|B2|Baseline|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter"
726908|NCT01708967|B1|Baseline|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)"
726909|NCT01708967|P2|Participant Flow|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
726910|NCT01708967|P1|Participant Flow|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
726911|NCT01708967|O2|Outcome|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
726912|NCT01708967|O1|Outcome|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
726913|NCT01708967|E2|Reported Event|Catheter-insertion Method|"We explored success rate, side effects, and vital signs in patients with spray+catheter method.~Intervention: use both spray and catheter~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
726951|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
726952|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
726953|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
727788|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
726914|NCT01708967|E1|Reported Event|Catheter-free Method|"We explored success rate, side effects, and vital signs in patients with one-time spray method.~Intervention: one-time spray of epinephrine (1cc) plus 4% lidocaine (4cc)~pretreatment method for transnasal endoscopy : one-time spray method : patients are given simethicone (5cc) and lidocaine (2%, 10cc). After that, epinephrine (1cc) and lidocaine (2%, 3cc) are injected in both nose and mouth. Lastly, buscopan Intra Muscular (IM) is injected.~spray+catheter method: patients are given simethicone (10cc). Next, epinephrine and lidocaine (4%, 4cc) are injected in both nose and mouth. Following this step, benoxinate hydrochloride (5cc) is inhaled by the patients. Subsequently, the patients are catheterized for 10 minutes using the 7Fr. Nelaton catheter. Finally, buscopan IM is injected."
726915|NCT01708954|B4|Baseline|Total|Total of all reporting groups
726916|NCT01708954|B3|Baseline|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726917|NCT01708954|B2|Baseline|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726918|NCT01708954|B1|Baseline|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726970|NCT01708902|B8|Baseline|Total|Total of all reporting groups
726919|NCT01708954|P3|Participant Flow|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726920|NCT01708954|P2|Participant Flow|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726921|NCT01708954|P1|Participant Flow|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726922|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726923|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726924|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726925|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726926|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726927|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726928|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726929|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726930|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726931|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726932|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726933|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726934|NCT01708954|O3|Outcome|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726935|NCT01708954|O2|Outcome|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726936|NCT01708954|O1|Outcome|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726937|NCT01708954|E4|Reported Event|Arm Z (Erlotinib+Cabozantinib; Step 2)|Patients achieving disease progression in Arm A or Arm B may receive erlotinib 150mg and cabozantinib 40mg as patients in Arm C. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726938|NCT01708954|E3|Reported Event|Arm C (Erlotinib+Cabozantinib)|Patients receive erlotinib 150mg PO daily and cabozantinib 40mg PO daily. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726939|NCT01708954|E2|Reported Event|Arm B (Cabozantinib)|Patients receive cabozantinib 60mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726940|NCT01708954|E1|Reported Event|Arm A (Erlotinib)|Patients receive erlotinib 150mg PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
726941|NCT01708915|B5|Baseline|Total|Total of all reporting groups
726942|NCT01708915|B4|Baseline|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
726943|NCT01708915|B3|Baseline|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
726944|NCT01708915|B2|Baseline|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
726945|NCT01708915|B1|Baseline|Placebo|Patients treated with placebo ointment
726946|NCT01708915|P4|Participant Flow|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
726947|NCT01708915|P3|Participant Flow|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
726954|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
726955|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
726956|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
726957|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
726958|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
726959|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
726960|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
726961|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
726962|NCT01708915|O4|Outcome|Nicoboxil/Nonivamide|Patients treated with ointments containing a combination of 2.5% nicoboxil and 0.4% nonivamide
726963|NCT01708915|O3|Outcome|Nonivamide|Patients treated with ointments containing 0.4% nonivamide alone
726964|NCT01708915|O2|Outcome|Nicoboxil|Patients treated with ointments containing 2.5% nicoboxil alone
726965|NCT01708915|O1|Outcome|Placebo|Patients treated with placebo ointment
727817|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
726971|NCT01708902|B7|Baseline|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
726972|NCT01708902|B6|Baseline|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
726973|NCT01708902|B5|Baseline|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
726974|NCT01708902|B4|Baseline|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
726975|NCT01708902|B3|Baseline|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
726976|NCT01708902|B2|Baseline|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
726977|NCT01708902|B1|Baseline|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
726978|NCT01708902|P7|Participant Flow|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
726979|NCT01708902|P6|Participant Flow|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg once daily (QD), administered oral as tablet.~(Data up to week 12)"
726980|NCT01708902|P5|Participant Flow|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
726981|NCT01708902|P4|Participant Flow|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg twice daily (BID), administered oral as fixed dose combination (FDC) tablet.
726982|NCT01708902|P3|Participant Flow|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg twice daily (BID), administered oral as tablet.
726983|NCT01708902|P2|Participant Flow|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg twice daily (BID), administered oral as tablet.
726984|NCT01708902|P1|Participant Flow|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg once daily (QD), administered oral as tablet.
726985|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
726986|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
726987|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
726988|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
726989|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
726990|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
726991|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
726992|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
726993|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
726994|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
726995|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
726996|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
727789|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
726997|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
726998|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
726999|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
727000|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
727001|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
727002|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
727003|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
727004|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
727005|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
727006|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
727007|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
727008|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
727009|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
727010|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
727011|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
727012|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
727013|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
727014|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
727015|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
727016|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
727017|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
727018|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
727019|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
727020|NCT01708902|O2|Outcome|APG: Linagliptin 2.5mg / Metformin 1000mg BID|"Additional parallel group (APG): Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
727021|NCT01708902|O1|Outcome|APG: Linagliptin 5mg QD|"Additional parallel group (APG): Patients received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
727022|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
727023|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
727024|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
727025|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
727026|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
727027|NCT01708902|O5|Outcome|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
727028|NCT01708902|O4|Outcome|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
727029|NCT01708902|O3|Outcome|Main: Metformin 1000mg BID|Main Group: Patients received metformin 1000mg BID, administered oral as tablet.
727030|NCT01708902|O2|Outcome|Main: Metformin 500mg BID|Main Group: Patients received metformin 500mg BID, administered oral as tablet.
727031|NCT01708902|O1|Outcome|Main: Linagliptin 5mg QD|Main Group: Patients received linagliptin 5mg QD, administered oral as tablet.
727032|NCT01708902|E10|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg After Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~Data from week 12 to week 24."
727033|NCT01708902|E9|Reported Event|APG: Linagliptin 5mg - Linagliptin 2.5mg / Met After Week 12|Additional parallel group (APG): Patients who received linagliptin 5mg QD, administered oral as tablet during the first 12 weeks and switched to linagliptin 2.5mg and metformin 1000mg (met) BID, administered oral as fixed dose combination (FDC) tablet from week 12 to week 24. Data from week 12 to week 24.
727127|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727034|NCT01708902|E8|Reported Event|APG: Linagliptin 5mg After Week 12|Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet. Data from week 12 to week 24
727035|NCT01708902|E7|Reported Event|APG: Linagliptin 2.5mg / Metformin 1000mg BID up to Week 12|"Additional parallel group (APG): Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.~(Data up to week 12)"
727036|NCT01708902|E6|Reported Event|APG: Linagliptin 5mg QD up to Week 12|"Additional parallel group (APG): Patients once daily received linagliptin 5mg QD, administered oral as tablet.~(Data up to week 12)"
727037|NCT01708902|E5|Reported Event|Main: Linagliptin 2.5mg / Metformin 1000mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 1000mg BID, administered oral as fixed dose combination (FDC) tablet.
727038|NCT01708902|E4|Reported Event|Main: Linagliptin 2.5mg / Metformin 500mg BID|Main Group: Patients twice daily received linagliptin 2.5mg and metformin 500mg BID, administered oral as fixed dose combination (FDC) tablet.
727039|NCT01708902|E3|Reported Event|Main: Metformin 1000mg BID|Main Group: Patients twice daily received metformin 1000mg BID, administered oral as tablet.
727040|NCT01708902|E2|Reported Event|Main: Metformin 500mg BID|Main Group: Patients twice daily received metformin 500mg BID, administered oral as tablet.
727041|NCT01708902|E1|Reported Event|Main: Linagliptin 5mg QD|Main Group: Patients once daily received linagliptin 5mg QD, administered oral as tablet.
727042|NCT01708525|B1|Baseline|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
727199|NCT01708057|E4|Reported Event|900 ug AZD8683|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler;
727043|NCT01708525|P1|Participant Flow|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
727044|NCT01708525|O2|Outcome|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera® System Treatment: Focused ultrasound energy delivered below the surface of the skin"
727045|NCT01708525|O1|Outcome|Untreated Tissue|Heavy water labeled tissue NOT receiving an Ultherapy® Treatment
727046|NCT01708525|E1|Reported Event|Ultherapy®-Treated Tissue|"Heavy water labeled tissue receiving an Ultherapy® Treatment~Ulthera System® Treatment: Focused ultrasound energy delivered below the surface of the skin"
727047|NCT01708317|B1|Baseline|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
727048|NCT01708317|P1|Participant Flow|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
727049|NCT01708317|O4|Outcome|Final Education Period|Participants seen in SLCH ED Dec 21, 2011 through March 2012 that met ACASI inclusion/exclusion criteria. During this period education continued and no ACASI enrollment was conducted.
727050|NCT01708317|O3|Outcome|ACASI + Education|Participants seen in SLCH ED April 18 - Dec 20 2011 that met ACASI inclusion/exclusion criteria. During this period education continued and ACASI enrollment was conducted.
727051|NCT01708317|O2|Outcome|Initial Education Period|Participants seen in SLCH ED Jan 1 - April 17 2011 during initial education period that met ACASI inclusion/exclusion criteria
727052|NCT01708317|O1|Outcome|Historical Control|Participants seen in SLCH ED in 2010 that met ACASI inclusion/exclusion criteria
727053|NCT01708317|E1|Reported Event|ACASI|"The group of patients that agreed to participate in the study and answer questions on our Audio-enhanced Computer-Assisted Self-Interview (ACASI)~ACASI : Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.~We compared testing over 4 time periods: 2010 (baseline), Jan - April 17, 2011 (education only), April 18-2011 - Dec 20, 2011 (education + enrollment in ACASI), and Dec 21, 2011 - March 31, 2012 (education only, ACASI enrollment stopped."
727054|NCT01708291|B3|Baseline|Total|Total of all reporting groups
727055|NCT01708291|B2|Baseline|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
727056|NCT01708291|B1|Baseline|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
727057|NCT01708291|P2|Participant Flow|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
727058|NCT01708291|P1|Participant Flow|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
727059|NCT01708291|O2|Outcome|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
727128|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
727060|NCT01708291|O1|Outcome|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
727061|NCT01708291|E2|Reported Event|No Mindfulness Based Stress Reduction|Will complete pre and post evaluation measures on the first and last sessions with no weekly sessions or mindfulness intervention program.
727062|NCT01708291|E1|Reported Event|Mindfulness Based Stress Reduction|Will complete 10 weekly sessions and comprised of an 8 week mindfulness intervention program and completing pre- and post-evaluation measures on the first and last sessions.
727063|NCT01708278|B7|Baseline|Total|Total of all reporting groups
727064|NCT01708278|B6|Baseline|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727065|NCT01708278|B5|Baseline|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727066|NCT01708278|B4|Baseline|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727200|NCT01708057|E3|Reported Event|300 ug AZD8683|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727067|NCT01708278|B3|Baseline|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727068|NCT01708278|B2|Baseline|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727069|NCT01708278|B1|Baseline|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727070|NCT01708278|P6|Participant Flow|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727071|NCT01708278|P5|Participant Flow|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727072|NCT01708278|P4|Participant Flow|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727073|NCT01708278|P3|Participant Flow|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727074|NCT01708278|P2|Participant Flow|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727075|NCT01708278|P1|Participant Flow|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727076|NCT01708278|O6|Outcome|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727077|NCT01708278|O5|Outcome|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727078|NCT01708278|O4|Outcome|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727079|NCT01708278|O3|Outcome|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727080|NCT01708278|O2|Outcome|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727081|NCT01708278|O1|Outcome|Sugar Chew- Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727129|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
727082|NCT01708278|E6|Reported Event|Sugar Chew-Cohort 3|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727083|NCT01708278|E5|Reported Event|Sugar Chew-Cohort 2|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727084|NCT01708278|E4|Reported Event|Quercetin 3-Cohort 3|"Quercetin chew containing 2000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727085|NCT01708278|E3|Reported Event|Quercetin 2-Cohort 2|"Quercetin chew containing 1000 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727086|NCT01708278|E2|Reported Event|Quercetin 1-Cohort 1|"Quercetin chew containing 500 mg quercetin, 350 mg vitamin C and 10 mg niacin~Quercetin: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
727087|NCT01708278|E1|Reported Event|Sugar Chew-Cohort 1|"contains 350 mg of vitamin C and 10 mg niacin~Placebo - sugar chew: COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)"
727088|NCT01708213|B1|Baseline|Dermal Filler - Aline HA|"Single armed study~Aline HA: Implantable dermal filler"
727089|NCT01708213|P1|Participant Flow|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
727090|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
727091|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
727092|NCT01708213|O1|Outcome|Dermal Filler - Aline HA|"Non-Randomized~Aline HA: Implantable dermal filler"
727093|NCT01708213|E1|Reported Event|Dermal Filler - Aline HA|To evaluate the safety and performance of Aline HA to treat mild to severe wrinkles in adult subjects
727094|NCT01708187|B3|Baseline|Total|Total of all reporting groups
727095|NCT01708187|B2|Baseline|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
727096|NCT01708187|B1|Baseline|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
727097|NCT01708187|P2|Participant Flow|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
727098|NCT01708187|P1|Participant Flow|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
727099|NCT01708187|O2|Outcome|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
727100|NCT01708187|O1|Outcome|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
727101|NCT01708187|E2|Reported Event|Control Arm Without Clarix™1k Graft|Group 2 received standard peroneal repair surgery without the use of the Clarix™1k tissue.
727102|NCT01708187|E1|Reported Event|Clarix™1k Graft|Group 1 received standard peroneal repair surgery with the addition of the Clarix™1k tissue.
727103|NCT01708174|B4|Baseline|Total|Total of all reporting groups
727104|NCT01708174|B3|Baseline|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727105|NCT01708174|B2|Baseline|Sonidegib (LDE225) Adults|600 mg orally
727106|NCT01708174|B1|Baseline|Sonidegib (LDE225) Children|500 mg/m2 orally
727107|NCT01708174|P3|Participant Flow|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727108|NCT01708174|P2|Participant Flow|Sonidegib (LDE225) Adults|600 mg orally
727109|NCT01708174|P1|Participant Flow|Sonidegib (LDE225) Children|500 mg/m2 orally
727110|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
727111|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
727112|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727113|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
727114|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
727115|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727116|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
727117|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
727118|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727119|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
727120|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
727121|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727122|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
727123|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
727124|NCT01708174|O3|Outcome|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727125|NCT01708174|O2|Outcome|Sonidegib (LDE225) Adults|600 mg orally
727126|NCT01708174|O1|Outcome|Sonidegib (LDE225) Children|500 mg/m2 orally
727130|NCT01708174|E4|Reported Event|Temozolomide (TMZ)|150 to 200 mg/m2 for 5 sequential days every 4 weeks according to prescribing information until the study was amended to a single arm study.
727131|NCT01708174|E3|Reported Event|Sonidegib (Total)|Sonidegib (Total)
727132|NCT01708174|E2|Reported Event|Sonidegib (LDE225) Adults|600 mg orally
727133|NCT01708174|E1|Reported Event|Sonidegib (LDE225) Children|500 mg/m2 orally
727134|NCT01708122|B3|Baseline|Total|Total of all reporting groups
727135|NCT01708122|B2|Baseline|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
727136|NCT01708122|B1|Baseline|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
727137|NCT01708122|P2|Participant Flow|Fentanyl|Subjects receiving either 50mcg or 100mcg
727138|NCT01708122|P1|Participant Flow|Placebo|"Subjects will receive 0.1 mL of intranasal saline as placebo.~saline: Sodium Chloride 0.9% intranasal spray"
727139|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
727140|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
727141|NCT01708122|O2|Outcome|Placebo|"Subjects will receive intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
727142|NCT01708122|O1|Outcome|Fentanyl|"Subjects will receive 50 to 100 mcg intranasal fentanyl~Fentanyl: 100 mcg in 1 mL intranasal spray"
727143|NCT01708122|E2|Reported Event|Placebo|"Subjects receiving either 0.5mL or 1 mL intranasal saline as placebo.~Saline: Sodium Chloride 0.9% intranasal spray"
727144|NCT01708122|E1|Reported Event|Fentanyl|"Subjects receiving either 0.5mL or 1 mL of intranasal fentanyl (50mcg or 100mcg)~Fentanyl: 100 mcg in 1 mL intranasal spray"
727145|NCT01708057|B1|Baseline|Total Baseline|All Patients population
727146|NCT01708057|P3|Participant Flow|DCEBFA|AZD8683 900 ug followed by AZD8683 300 ug followed by Spiriva® 18 ug followed by AZD8683 150 ug followed by Placebo followed by AZD8683 50 ug
727147|NCT01708057|P2|Participant Flow|FEADBC|Placebo followed by Spiriva® 18 ug followed by AZD8683 50 ug followed by AZD8683 900 ug followed by AZD8683 150 ug followed by AZD8683 300 ug
727148|NCT01708057|P1|Participant Flow|AFBECD|AZD8683 50 ug followed by Placebo followed by AZD8683 150 ug followed by Spiriva® 18 ug followed by AZD8683 300 ug followed by AZD8683 900 ug
727149|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727150|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727151|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727152|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727153|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727154|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727155|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727156|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727157|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727158|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727159|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727160|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727161|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727162|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727163|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727164|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727165|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727166|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727167|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727168|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727169|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727170|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727171|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727172|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727173|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727174|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727175|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727176|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727177|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727178|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727179|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727180|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727181|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727182|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727183|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727184|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727185|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727186|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727187|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727188|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727189|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727190|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727191|NCT01708057|O6|Outcome|AZD8683 50ug|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727192|NCT01708057|O5|Outcome|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727193|NCT01708057|O4|Outcome|Spiriva 18 ug|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727194|NCT01708057|O3|Outcome|AZD8683 900ug|AZD8683 900 ug via Turbuhaler + placebo for Spiriva via HandiHaler
727195|NCT01708057|O2|Outcome|AZD8683 300ug|AZD8683 300 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727196|NCT01708057|O1|Outcome|AZD8683 150 ug|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727197|NCT01708057|E6|Reported Event|Placebo|Turbuhaler® Placebo+Handihaler® Placebo for Spiriva®
727198|NCT01708057|E5|Reported Event|18ug Spiriva|Turbuhaler® Placebo+Handihaler® Spiriva® 18 μg
727201|NCT01708057|E2|Reported Event|150 ug AZD8683|AZD8683 150 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727202|NCT01708057|E1|Reported Event|50ug AZD8683|AZD8683 50 ug via Turbuhaler + Turbuhaler Placebo +Handihaler Placebo for Spiriva
727203|NCT01707667|B3|Baseline|Total|Total of all reporting groups
727204|NCT01707667|B2|Baseline|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
727205|NCT01707667|B1|Baseline|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
727206|NCT01707667|P2|Participant Flow|PEG-PRU|Two doses of PEG 3350 (13.8g) plus electrolytes in the first period followed by a single dose of prucalopride 2mg in the second period.
727207|NCT01707667|P1|Participant Flow|PRU-PEG|A single dose of prucalopride 2mg in the first period followed by 2 doses of polyethylene glycol (PEG) 3350 (13.8g) plus electrolytes in the second period.
727208|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727209|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727210|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727211|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727212|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727213|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727214|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727215|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727216|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727217|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727218|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727219|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727220|NCT01707667|O2|Outcome|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727221|NCT01707667|O1|Outcome|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727222|NCT01707667|E2|Reported Event|Polyethylene Glycol|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1 (once in the morning and once prior to lunch).
727223|NCT01707667|E1|Reported Event|Prucalopride|A single dose of 2mg prucalopride, administered orally as tablets with 125mL of water on Day 1.
727224|NCT01707654|B1|Baseline|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
727225|NCT01707654|P1|Participant Flow|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
727226|NCT01707654|O1|Outcome|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
727227|NCT01707654|E1|Reported Event|Nerve Graft|Simultaneous repair of the infected wound and digital nerve defect in the finger using a bipedicled nerve flap including nerve graft from the dorsal branch of the digital nerve.
727228|NCT01707290|B3|Baseline|Total|Total of all reporting groups
727229|NCT01707290|B2|Baseline|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
727230|NCT01707290|B1|Baseline|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
727231|NCT01707290|P2|Participant Flow|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
727232|NCT01707290|P1|Participant Flow|Ivacaftor Arm|Participants who received Ivacaftor 150 milligram (mg) tablet and/or Placebo matched to Ivacaftor tablet, every 12 hours (q12h) in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
727233|NCT01707290|O1|Outcome|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet, orally, q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
727551|NCT01705652|E2|Reported Event|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
727234|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727235|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727236|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727237|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727238|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727239|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727240|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727241|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727242|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727243|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727244|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727245|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727246|NCT01707290|O3|Outcome|Ivacaftor Arm: Study 113|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 113; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727247|NCT01707290|O2|Outcome|Ivacaftor Arm: Study 111|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 111; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727248|NCT01707290|O1|Outcome|Ivacaftor Arm: Study 110|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet orally, q12h in the previous Study 110; received Ivacaftor 150 mg tablet q12h in this Study 112 up to 104 weeks.
727249|NCT01707290|O1|Outcome|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
727250|NCT01707290|E2|Reported Event|Observational Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous Study 110 (NCT01614457) or Study 111 (NCT01614470), were observed (did not receive study drug) in this Study 112 (NCT01707290) for up to 2 years.
727251|NCT01707290|E1|Reported Event|Ivacaftor Arm|Participants who received Ivacaftor 150 mg tablet and/or Placebo matched to Ivacaftor tablet q12h in the previous study VX11-770-110 (Study 110; NCT01614457), VX12-770-111 (Study 111; NCT01614470) or VX12-770-113 (Study 113; NCT01685801); received Ivacaftor 150 mg tablet orally q12h in this VX12-770-112 (Study 112; NCT01707290) up to 104 weeks.
727252|NCT01707238|B3|Baseline|Total|Total of all reporting groups
727435|NCT01706666|B3|Baseline|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
727253|NCT01707238|B2|Baseline|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
727254|NCT01707238|B1|Baseline|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
727255|NCT01707238|P2|Participant Flow|Etafilcon A Then Stenfilcon A|All subjects assigned as overall study population wore both sets of lenses. Study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
727256|NCT01707238|P1|Participant Flow|Stenfilcon A Then Etafilcon A|All subjects assigned as overall study population wore both sets of lenses. Overall study population was randomized to wear either stenfilcon A followed by etafilcon A or etafilcon A followed by stenfilcon A.
727257|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727258|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727259|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727552|NCT01705652|E1|Reported Event|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
727260|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727261|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727262|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727263|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727264|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.).
727265|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727266|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727267|NCT01707238|O2|Outcome|Etafilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727268|NCT01707238|O1|Outcome|Stenfilcon A|Participants randomized to wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks. (Stenfilcon A then etafilcon A and/or etafilcon A then stenfilcon A.)
727269|NCT01707238|E2|Reported Event|Etafilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
727270|NCT01707238|E1|Reported Event|Stenfilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
727271|NCT01707225|B1|Baseline|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
727272|NCT01707225|P1|Participant Flow|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
727291|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727790|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727273|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
727293|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727316|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727274|NCT01707225|O1|Outcome|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
727275|NCT01707225|E1|Reported Event|Octreotide LAR Depot|"Once enrolled in the study subjects will receive a monthly IM injection of 20mg of octreotide LAR at each study visit for 24 weeks and will be followed for a total of 36 weeks.~Octreotide LAR Depot: subject seen in clinic every 4 weeks (+/- 4 days) through week 24. Weeks 25-36 subject will receive a call every 4 weeks +/- 4 days, to assess for changes after the study drug was stopped. Subjects will receive a exam and interview at each visit to assess for GI bleeding at home and for drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study."
727276|NCT01707095|B3|Baseline|Total|Total of all reporting groups
727277|NCT01707095|B2|Baseline|Unbundling of Cords|"The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another~Unbundling of cords: The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another"
727278|NCT01707095|B1|Baseline|Bundling of Cords|"The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.~Bundling of cords: The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy."
727279|NCT01707095|P2|Participant Flow|Unbundled / Separated|Active electrode cord and camera cord separated
727280|NCT01707095|P1|Participant Flow|Bundled|Active electrode cord and camera cord parallel
727281|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
727282|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
727283|NCT01707095|O2|Outcome|Unbundled / Separated|Active electrode cord and camera cord separated
727284|NCT01707095|O1|Outcome|Bundled|Active electrode cord and camera cord parallel
727285|NCT01707095|E2|Reported Event|Unbundled / Separated|Active electrode cord and camera cord separated
727286|NCT01707095|E1|Reported Event|Bundled|Active electrode cord and camera cord parallel
727287|NCT01706952|B1|Baseline|Cocaine/Adrenaline|"Three cotton neuropatties will be placed in each nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727288|NCT01706952|P1|Participant Flow|Cocaine/Adrenaline|"Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).~Three cotton neuropatties will be placed in each side of the nostril. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose."
727289|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727290|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727434|NCT01706666|B4|Baseline|Total|Total of all reporting groups
727292|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727315|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727294|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727295|NCT01706952|O2|Outcome|Adrenaline SIDE|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727296|NCT01706952|O1|Outcome|Cocaine SIDE|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727297|NCT01706952|E2|Reported Event|Adrenaline|"Adrenaline 1/1.000 Three cotton neuropatties will be soaked with Adrenaline 1/1,000. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727298|NCT01706952|E1|Reported Event|Cocaine|"Cocaine 4%. Three cotton neuropatties will be soaked with 4% cocaine. One neuropattie will be placed in the sphenoethmoidal recess, one in the middle meatus, and one in the anterior end of the middle turbinates on the side that the randomization has determined.~This intervention will be done before the beginning of the surgery, and will be left in the nose for 10 minutes, this will be done just once. After the 10 minutes, the neuropatties will be taken out of the nose.~Cocaine: Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).~Adrenaline: Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side)."
727299|NCT01706926|B5|Baseline|Total|Total of all reporting groups
727300|NCT01706926|B4|Baseline|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727301|NCT01706926|B3|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727302|NCT01706926|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727303|NCT01706926|B1|Baseline|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727304|NCT01706926|P4|Participant Flow|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727305|NCT01706926|P3|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727306|NCT01706926|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727307|NCT01706926|P1|Participant Flow|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727308|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727309|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727310|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727311|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727312|NCT01706926|O3|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727313|NCT01706926|O2|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727314|NCT01706926|O1|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727553|NCT01705574|B3|Baseline|Total|Total of all reporting groups
727818|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727317|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727318|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727319|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727320|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727321|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727322|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727323|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727324|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727325|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727326|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727327|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727328|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727329|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727330|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727331|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727332|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727333|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727334|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727335|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727336|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727337|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727338|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727339|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727340|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727341|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727342|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727343|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727344|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727345|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727346|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727347|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727348|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727349|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727350|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727351|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727352|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727353|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727354|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727355|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727356|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727357|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727358|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727359|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727360|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727361|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727362|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727363|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727364|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727365|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727366|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727367|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727368|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727369|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727370|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727371|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727372|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727373|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727374|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727375|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727376|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727377|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727378|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727379|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727380|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727381|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727382|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727383|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727384|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727385|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727386|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727387|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727388|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727389|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727390|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727391|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727392|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727393|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727394|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727395|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727396|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727397|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727398|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727399|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727400|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727401|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727402|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727403|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727404|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727405|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727406|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727407|NCT01706926|O4|Outcome|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727408|NCT01706926|O3|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727409|NCT01706926|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727410|NCT01706926|O1|Outcome|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727411|NCT01706926|E4|Reported Event|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727412|NCT01706926|E3|Reported Event|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727413|NCT01706926|E2|Reported Event|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
727414|NCT01706926|E1|Reported Event|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 milligram [mg] per week) through oral or parenteral route.
727415|NCT01706822|B1|Baseline|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
727416|NCT01706822|P1|Participant Flow|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
727417|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
727418|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
727419|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
727420|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
727421|NCT01706822|O1|Outcome|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy.
727422|NCT01706822|E1|Reported Event|Covidien Radial Reload Stapler With Tri-Staple Technology|Covidien Radial Reload Stapler with Tri-Staple Technology in laparoscopic low anterior resection or proctosigmoidectomy
727423|NCT01706770|B3|Baseline|Total|Total of all reporting groups
727424|NCT01706770|B2|Baseline|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727425|NCT01706770|B1|Baseline|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727426|NCT01706770|P2|Participant Flow|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727427|NCT01706770|P1|Participant Flow|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727428|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727429|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727430|NCT01706770|O2|Outcome|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727431|NCT01706770|O1|Outcome|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727432|NCT01706770|E2|Reported Event|Galyfilcon A|The control (active comparator) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727433|NCT01706770|E1|Reported Event|Enfilcon A|The test (experimental) lens is a silicone hydrogel contact lens following a daily wear 1 week planned replacement modality.
727436|NCT01706666|B2|Baseline|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727437|NCT01706666|B1|Baseline|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727438|NCT01706666|P3|Participant Flow|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
727439|NCT01706666|P2|Participant Flow|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727440|NCT01706666|P1|Participant Flow|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727441|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
727442|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727443|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727444|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
727807|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727445|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727446|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727447|NCT01706666|O3|Outcome|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
727448|NCT01706666|O2|Outcome|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727449|NCT01706666|O1|Outcome|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727450|NCT01706666|E3|Reported Event|Arm C|Patients receive bortezomib SC as in Arm A and lenalidomide PO QD on days 1-28.
727451|NCT01706666|E2|Reported Event|Arm B|Patients receive bortezomib SC as in Arm A, cyclophosphamide PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24, and dexamethasone PO on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727452|NCT01706666|E1|Reported Event|Arm A|Patients receive bortezomib SC on days 1 and 15 of courses 1-12 and day 1 of courses 13-24.
727453|NCT01706588|B6|Baseline|Total|Total of all reporting groups
727454|NCT01706588|B5|Baseline|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727455|NCT01706588|B4|Baseline|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727456|NCT01706588|B3|Baseline|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727457|NCT01706588|B2|Baseline|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727458|NCT01706588|B1|Baseline|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727459|NCT01706588|P5|Participant Flow|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727460|NCT01706588|P4|Participant Flow|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727461|NCT01706588|P3|Participant Flow|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727462|NCT01706588|P2|Participant Flow|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727463|NCT01706588|P1|Participant Flow|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727464|NCT01706588|O5|Outcome|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727465|NCT01706588|O4|Outcome|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727466|NCT01706588|O3|Outcome|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727467|NCT01706588|O2|Outcome|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727468|NCT01706588|O1|Outcome|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727469|NCT01706588|E5|Reported Event|Placebo 1 mL|One single placebo injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727470|NCT01706588|E4|Reported Event|Diclofenac Sodium 50 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727471|NCT01706588|E3|Reported Event|Diclofenac Sodium 25 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727472|NCT01706588|E2|Reported Event|Diclofenac Sodium 12.5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727473|NCT01706588|E1|Reported Event|Diclofenac Sodium 5 mg/mL|Diclofenac sodium: One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
727791|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727474|NCT01706575|B1|Baseline|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727475|NCT01706575|P1|Participant Flow|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727476|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727477|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727808|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727478|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727479|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727480|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727481|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727482|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727483|NCT01706575|O1|Outcome|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727484|NCT01706575|E1|Reported Event|Pegylated Interferon (Peginterferon) Alfa-2a|Participants receiving nucleos(t)ide analogues (NA) therapy with Hepatitis B surface Antigen (HBsAg) decline less than <0.5 log 10 international unit/milliliter (IU/ml) at baseline received peginterferon alfa-2a 180 microgram (mcg), subcutaneously (SC) once weekly for 48 weeks along with their NA therapy.
727485|NCT01706549|B1|Baseline|Postoperative Pain|Observational study on posthysterectomy pain
727486|NCT01706549|P1|Participant Flow|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
727487|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
727488|NCT01706549|O1|Outcome|Posthysterectomy Pain|Observational study on posthysterectomy pain. Participants recruited from previous studies. Recruitment completed.
727489|NCT01706549|E1|Reported Event|Posthysterectomy Pain|This was an observational study, thus no adverse events were collected.
727490|NCT01706328|B3|Baseline|Total|Total of all reporting groups
727491|NCT01706328|B2|Baseline|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
727492|NCT01706328|B1|Baseline|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
727493|NCT01706328|P3|Participant Flow|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
727494|NCT01706328|P2|Participant Flow|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
727495|NCT01706328|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo twice a day (one inhalation from a multi-dose powder inhaler [MPI] and one inhalation from a dry powder inhaler [DPI] in the morning; one inhalation from an MPI in the evening). In addition, all participants received supplemental albuterol (salbutamol) (via a metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
727496|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
727497|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
727498|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
727524|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
727499|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
727500|NCT01706328|O2|Outcome|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
727501|NCT01706328|O1|Outcome|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
727502|NCT01706328|E2|Reported Event|FP/Salmeterol 250/50 µg BID|Participants received fluticasone propionate (FP)/salmeterol 250/50 µg BID from a DPI (one inhalation in the morning and one inhalation in the evening) plus placebo QD in the morning from a DPI for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) to be used as needed throughout the study.
727503|NCT01706328|E1|Reported Event|FF/VI 100/25 µg QD|Participants received one inhalation of fluticasone furoate/vilanterol (FF/VI) 100/25 micrograms (µg) once daily (QD) in the morning from a DPI and placebo twice daily (BID) from a DPI (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol (salbutamol) inhalation to be used as needed throughout the study.
727504|NCT01706159|B3|Baseline|Total|Total of all reporting groups
727505|NCT01706159|B2|Baseline|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727506|NCT01706159|B1|Baseline|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727507|NCT01706159|P2|Participant Flow|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727508|NCT01706159|P1|Participant Flow|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727509|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727510|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727511|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727512|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727513|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727514|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727515|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727516|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727517|NCT01706159|O2|Outcome|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727518|NCT01706159|O1|Outcome|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727519|NCT01706159|E2|Reported Event|Placebo|Placebo formulation was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week. The doses were administered for a total of 4 doses.
727520|NCT01706159|E1|Reported Event|rFXIII|Recombinant factor XIII (rFXIII) was administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) at a dose of 35 IU/kg. The doses were administered once every second week for a total of 4 doses.
727521|NCT01706146|B1|Baseline|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
727522|NCT01706146|P1|Participant Flow|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
727523|NCT01706146|O1|Outcome|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
727809|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727525|NCT01706146|E1|Reported Event|Non-Coumadin Oral Anticoagulant|"Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.~Non-coumadin Oral Anticoagulant: Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device."
727526|NCT01705717|B3|Baseline|Total|Total of all reporting groups
727527|NCT01705717|B2|Baseline|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727528|NCT01705717|B1|Baseline|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727529|NCT01705717|P2|Participant Flow|Hepatitis C Virus (HCV) – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727530|NCT01705717|P1|Participant Flow|Non-Cirrhotic Chronic Hepatitis C (CHC) Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727531|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727532|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727533|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727534|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727535|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727536|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727537|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727538|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727539|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727540|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727541|NCT01705717|O2|Outcome|HCV – Related Cirrhosis Observation Only|Participants with newly diagnosed during the years 2000 through 2010 HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727542|NCT01705717|O1|Outcome|Non-Cirrhotic CHC Observation Only|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727543|NCT01705717|E1|Reported Event|All Participants|Participants with newly diagnosed during the years 2000 through 2010 non-cirrhotic CHC or HCV-related compensated cirrhosis and related morbidities were treated per the standard of care or local clinical practice and at the discretion of the physician for up to 36 months.
727544|NCT01705652|B3|Baseline|Total|Total of all reporting groups
727545|NCT01705652|B2|Baseline|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment. Minimum of 30 days and maximum of 60 days prior to the start of radiation therapy and then during treatment. The final dose is taken the last day of radiation.
727546|NCT01705652|B1|Baseline|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery. Minimum of 30 days and maximum of 80 days before surgery. The final dose is taken the day before surgery.
727547|NCT01705652|P2|Participant Flow|Nexrutine Radiation Group|Radiation Group: Nexrutine 500mg by mouth, three times per day, given prior to and during radiation treatment.
727548|NCT01705652|P1|Participant Flow|Nexrutine Surgery Group|Surgery Group: Nexrutine 500mg by mouth, three times per day, given prior to surgery.
727549|NCT01705652|O2|Outcome|Surgery Group|Nexrutine by mouth three times per day prior to surgery for a minimum of 30 days and maximum of 80 days. The final dose is taken the day before surgery.
727550|NCT01705652|O1|Outcome|Radiation Group|Nexrutine by mouth three times per day for a minimum of 30 days and a maximum of 60 days prior to the start of radiation therapy and during treatment. The final dose will be taken the last day of radiation.
727954|NCT01704404|E3|Reported Event|Dose 3 TD-4208|"88 µg~TD-4208"
727554|NCT01705574|B2|Baseline|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
727555|NCT01705574|B1|Baseline|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
727556|NCT01705574|P2|Participant Flow|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (Truvada®; 200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
727557|NCT01705574|P1|Participant Flow|E/C/F/TDF|Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) fixed-dose combination (FDC) + atazanavir (ATV) placebo + ritonavir (RTV) placebo + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily for 48 weeks
727558|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
727559|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
727560|NCT01705574|O2|Outcome|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
727561|NCT01705574|O1|Outcome|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
727562|NCT01705574|E2|Reported Event|ATV+RTV+FTC/TDF|Double-Blind Phase: ATV 300 mg boosted with RTV 100 mg + FTC/TDF (200/300 mg) FDC + E/C/F/TDF placebo once daily for 48 weeks
727563|NCT01705574|E1|Reported Event|E/C/F/TDF|Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC + ATV placebo + RTV placebo + FTC/TDF placebo once daily for 48 weeks
727564|NCT01705496|B1|Baseline|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727565|NCT01705496|P1|Participant Flow|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727566|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727567|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727568|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727569|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727570|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727571|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727572|NCT01705496|O1|Outcome|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727600|NCT01705145|E2|Reported Event|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
727573|NCT01705496|E1|Reported Event|[124I]FIAU|"Single dose study of [124I]FIAU in patients presenting with pain in a prosthetic knee or hip joint who will undergo PET-CT scanning.~[124I]FIAU: This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection."
727574|NCT01705145|B1|Baseline|Ivacaftor|"Part A: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
727575|NCT01705145|P1|Participant Flow|Ivacaftor|"Part A: Ivacaftor 50 milligram (mg) (for participants weighing less than [<] 14 kilograms [kg]) or 75 mg (for participants weighing greater than or equal to [>=] 14 kg) every 12 hours (q12h) from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.~Part B: Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants."
727576|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727577|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727578|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727579|NCT01705145|O1|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
727580|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727581|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727582|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727583|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727584|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727585|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727586|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727587|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727588|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727589|NCT01705145|O1|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727590|NCT01705145|O3|Outcome|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727591|NCT01705145|O2|Outcome|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727592|NCT01705145|O1|Outcome|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727593|NCT01705145|O3|Outcome|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
727594|NCT01705145|O2|Outcome|Part A: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
727595|NCT01705145|O1|Outcome|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
727596|NCT01705145|E6|Reported Event|Part B: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727597|NCT01705145|E5|Reported Event|Part B: Ivacaftor 75 mg|Ivacaftor 75 mg (for participants weighing >=14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727598|NCT01705145|E4|Reported Event|Part B: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h for 24 weeks during Part B of the study. Part B included participants from Part A and newly enrolled participants.
727599|NCT01705145|E3|Reported Event|Part A: Overall Ivacaftor|Ivacaftor 50 mg (for participants weighing <14 kg) or 75 mg (for participants weighing >=14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
727675|NCT01704755|B3|Baseline|Total|Total of all reporting groups
727601|NCT01705145|E1|Reported Event|Part A: Ivacaftor 50 mg|Ivacaftor 50 mg (for participants weighing <14 kg) q12h from Day 1 through Day 3 and 1 morning dose on Day 4 during Part A of the study.
727602|NCT01704976|B3|Baseline|Total|Total of all reporting groups
727603|NCT01704976|B2|Baseline|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727604|NCT01704976|B1|Baseline|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727605|NCT01704976|P2|Participant Flow|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727606|NCT01704976|P1|Participant Flow|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727607|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727608|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727810|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727609|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727610|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727611|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727612|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727613|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727614|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727615|NCT01704976|O2|Outcome|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727616|NCT01704976|O1|Outcome|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727617|NCT01704976|E2|Reported Event|Sham|"T0- Intervention 4 weeks- T1~Stochastic resonance whole-body vibration II: Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1."
727618|NCT01704976|E1|Reported Event|Intervention|"T0 - intervention 4 weeks - T1~Stochastic resonance whole-body vibration I: Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4."
727619|NCT01704846|B3|Baseline|Total|Total of all reporting groups
727620|NCT01704846|B2|Baseline|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
727621|NCT01704846|B1|Baseline|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
727622|NCT01704846|P2|Participant Flow|Treatment Sequence 2|"Treatment sequence: Reference - Test - Test - Reference~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
727623|NCT01704846|P1|Participant Flow|Treatment Sequence 1|"Treatment sequence: Test - Reference - Reference - Test~Test product: Oral administration of faldaprevir 120 mg (40 mg x 3 soft gelatine capsules) with 150 mL water after an overnight fast.~Reference Product: Oral administration of faldaprevir 120 mg (120 mg x 1 soft gelatine capsule) with 150 mL water after an overnight fast.~Treatments were separated by a washout period of at least 14 days."
727624|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727625|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727626|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727627|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727628|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727629|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727630|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727631|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727632|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727633|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727634|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727635|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727636|NCT01704846|O2|Outcome|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727637|NCT01704846|O1|Outcome|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727638|NCT01704846|E2|Reported Event|Reference Product: Faldaprevir 120 mg x 1 Capsule|Faldaprevir 120 mg (120 mg x 1 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727639|NCT01704846|E1|Reported Event|Test Product: Faldaprevir 40 mg x 3 Capsules|Faldaprevir 120 mg (40 mg x 3 capsules) - soft gelatine capsule- Oral administration with 150 mL water after an overnight fast
727640|NCT01704781|B6|Baseline|Total|Total of all reporting groups
727641|NCT01704781|B5|Baseline|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727642|NCT01704781|B4|Baseline|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727643|NCT01704781|B3|Baseline|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
727644|NCT01704781|B2|Baseline|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
727645|NCT01704781|B1|Baseline|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
727646|NCT01704781|P5|Participant Flow|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727647|NCT01704781|P4|Participant Flow|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727648|NCT01704781|P3|Participant Flow|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
727649|NCT01704781|P2|Participant Flow|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
727650|NCT01704781|P1|Participant Flow|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
727651|NCT01704781|O5|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727652|NCT01704781|O4|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727653|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
727654|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
727655|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
727676|NCT01704755|B2|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
727656|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727657|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727658|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727659|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727660|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727661|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727662|NCT01704781|O2|Outcome|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727663|NCT01704781|O1|Outcome|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727664|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
727665|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
727666|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
727667|NCT01704781|O3|Outcome|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
727668|NCT01704781|O2|Outcome|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
727669|NCT01704781|O1|Outcome|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
727670|NCT01704781|E5|Reported Event|Part B: Lenalidomide Placebo|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide placebo two days prior to and at the day of immunization.~Lenalidomide placebo: Capsules are identical to the active Lenalidomide capsules used.~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727671|NCT01704781|E4|Reported Event|Part B: Lenalidomide|"Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide for 6 immunizations (visit 2, 3, 4, 5, 6 and 7) & lenalidomide (dose determined in Part A) two days prior to and at the day of immunization.~Lenalidomide: In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A~Vacc-4X: Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.~rhuGM-CSF: Granulocyte macrophage colony stimulating factor as a local adjuvant"
727672|NCT01704781|E3|Reported Event|Part A: Lenalidopmide 25 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 25 mg
727673|NCT01704781|E2|Reported Event|Part A: Lenalidomide 10 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 10 mg
727674|NCT01704781|E1|Reported Event|Part A: Lenalidomide 5 mg|Intradermal Vacc-4x (1.2 mg) given with Leukine® (rhu-GM-CSF) (0.06 mg) and oral lenalidomide 5 mg
727677|NCT01704755|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
727678|NCT01704755|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
727679|NCT01704755|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
727680|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
727681|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
727682|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
727683|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
727684|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
727685|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
727686|NCT01704755|O2|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
727687|NCT01704755|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
727688|NCT01704755|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 24 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 24 weeks
727689|NCT01704755|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV for 12 Weeks|ABT-450/r/ABT-267 (150/100/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; 1,000 mg/day if <75 kg or 1,200 mg/day if ≥75 kg, divided twice daily) for 12 weeks
727690|NCT01704651|B3|Baseline|Total|Total of all reporting groups
727691|NCT01704651|B2|Baseline|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
727692|NCT01704651|B1|Baseline|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
727693|NCT01704651|P2|Participant Flow|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
727694|NCT01704651|P1|Participant Flow|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
727695|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
727696|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
727697|NCT01704651|O2|Outcome|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
727698|NCT01704651|O1|Outcome|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
727699|NCT01704651|E2|Reported Event|Placebo|Perioperative administration of oral placebo, at same dosing interval as study drug, starting with one dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days..
727700|NCT01704651|E1|Reported Event|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.
727701|NCT01704599|B1|Baseline|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
727702|NCT01704599|P1|Participant Flow|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
727703|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks (week 28)."
727704|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this, therapy can stop or continue . Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject."
727705|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The one arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks."
727706|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|"Humira then Humira plus 3 B vitamins~The only arm: After 16 weeks on adalimumab, modulators of homocysteine (oral vitamin B12, oral vitamin B6 or pyridoxine, and oral folic acid) will be added to adalimumab therapy for an additional 12 weeks. At end of this therapy can stop or continue. Telephone call day 70 after formal end of in person study the investigators will assess general health of each subject.~Humira Then Humira plus 3 B vitamins: Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin"
727707|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages 18-65 with moderate to severe plaque psoriasis with PASI measured week 0 on no systemic psoriasis medication, weeks 4 and 16 after 4 and 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab plus 12 weeks of adalimumab and 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12 ranked by calculated Body Mass Index (BMI) week 0.
727708|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis. Weight measurement were in pounds measured at Weeks 16 and 28.
727709|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults age 18-65 yearswith moderate to severe plaque psoriasis measured at week 0 of study on no systemic psoriasis medication.
727710|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Temperature measurements in adults ages 18-65 with moderate to severe plaque psoriasis at week16 on adalimuamb and week 28 temperatures on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
727711|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Subjects were adults with moderate to severe plaque psoriasis with test to be measured week 0 on no systemic psoriasis medication, week 16 after 16 weeks adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
727712|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|One adult psoriasis subject age 23 with moderate to severe plaque psoriasis with pregnanacy test on enrollment on no systemic psoriasis therapy.
727713|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adults ages18-65 with moderate to severe plaque psoriasis tested at week 0 on no systemic psoriasis therapy; week 16 after 16 weeks of adalimumab and week 28 after 16 weeks adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12.
727714|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab and daily 5 mg folic acid 100 mg vitamin B6 and 1000 mcg B12.
727715|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 years with moderate to severe plaque psoriasis measured at week 16 after 16 weeks adalimumab and week 28 after 28 weeks adalimumab annd 12 weeks on adalimumab, folic acid 5 mg, 100 mg B6 and 1000 mcg B12.
727716|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis.
727717|NCT01704599|O1|Outcome|Humira Plus 3 B Vitamins|adults 18-65 with plaque psoriasis (moderate to severe) measured at week 0 on no systemic psoriasis medication; week 16 after 16 weeks adalimumab and at 28 weeks after 16 weeks adalimumab plus 12 weeks folic acid, vitamin B6 and B12.
727718|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults 18-65 all with moderate to severe plaque psoriasis. Week 0 (on no systemic psoriasis medication), Week 16 ( 16 weeks adalimumab), Week 28 ( 16 weeks on adalimumab plus 12 weeks on adalimumab plus 5 mg folic acid, 100 mg B6 and 1000 mcg B12 daily.
727719|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|8 adult 18-65 year old moderate to severe plaque psoriasis patients with levels measured weeks 0,16 and 28 in 4 subjects; weeks 0 and 16 in one subject, weeks 16 and 28 in one subject and week 0 only in 2 subjects.
727720|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult subjects ages 18-65 with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication ,week 16 after 16 wqeeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus folic acid 5 mg. vitamin B6 100 mg and vitamin B12 1000 mcg daily assessing CBC with diferential for increase, decrease and no change.
727721|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis with subject serum levels to be measured weeks 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab and then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of vitamin B12.
727722|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis measured at week 0 on no systemic psoriasis medication; week 16 on adalimumab for 16 weeks and then week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
727723|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adult 18-65 year old adults with moderate to severe plaque psoriasis with adverse event documented sometime during the 28 week study plus telephone call day 70 post week 28 visit either with knowledge of serious event of adverse event documented from data taken weeks 4 and 16 on adalimumab alone and week 28 after 16 weeks on adalimumab plus 12 weeks on adalimumab and daily 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12 and a telephone call day 70 post week 28 study visit and a telephone call day 70 post week 28 visit.
727724|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis evaluated at after week 16 of study on or after of adalimumab then 12 weeks of adalimumab plus daily 5 mg folic acid, 100 mg vitamin B6 and vitamin B12 or during the 10 weeks after that.
727725|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 years with moderate to severe plaque psoriasis evaluated at week 0 on no systemic psoriasis medication; weeks 16 after 16 weeks adalimumab and 28 after 16 weeks adalimumab then 12 weeks adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg B12.
727726|NCT01704599|O1|Outcome|Humira Then Humira Plus 3 B Vitamins|Adults ages 18-65 with moderate to severe plaque psoriasis measured at week 16 after 16 weeks of adalimumab and week 28 after 16 weeks of adalimumab then 12 weeks of adalimumab plus 5 mg folic acid, 100 mg vitamin B6 and 1000 mcg of B12.
727727|NCT01704599|E1|Reported Event|Humira Then Humira Plus 3 B Vitamins|Pneumonia while on adaimumab and before the adalimumab plus B vitamins were begun.prior to vitamins
727728|NCT01704521|B3|Baseline|Total|Total of all reporting groups
727729|NCT01704521|B2|Baseline|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin.
727730|NCT01704521|B1|Baseline|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin.
727731|NCT01704521|P2|Participant Flow|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
727732|NCT01704521|P1|Participant Flow|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
727811|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727955|NCT01704404|E2|Reported Event|Dose 2 TD-4208|"44 µg~TD-4208"
727733|NCT01704521|O2|Outcome|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration PegInterferon + Ribavirin
727734|NCT01704521|O1|Outcome|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
727735|NCT01704521|E2|Reported Event|No Lead-in|No 4 week lead-in: Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin + Telaprevir for 12 weeks followed by variable duration of PegInterferon + Ribavirin
727736|NCT01704521|E1|Reported Event|Lead-In|Kinetic assessment of response guided treatment per standard of care with PegInterferon + Ribavirin for 4 weeks followed by 12 weeks of PegInterferon + Ribavirin + Telaprevir followed by variable duration of PegInterferon + Ribavirin
727737|NCT01704495|B5|Baseline|Total|Total of all reporting groups
727738|NCT01704495|B4|Baseline|Placebo|Placebo oral capsules self-administred twice daily
727739|NCT01704495|B3|Baseline|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727740|NCT01704495|B2|Baseline|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727741|NCT01704495|B1|Baseline|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727742|NCT01704495|P4|Participant Flow|Placebo|Placebo oral capsules self-administred twice daily
727743|NCT01704495|P3|Participant Flow|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727744|NCT01704495|P2|Participant Flow|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727745|NCT01704495|P1|Participant Flow|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727746|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727747|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727748|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727749|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727750|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727751|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727752|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727753|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727754|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727755|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727756|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727757|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727758|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727759|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727760|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727761|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727762|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727763|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727764|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727765|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727766|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727767|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727768|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727769|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727770|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727771|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727772|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727773|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727774|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727775|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727776|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727792|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727793|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727794|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727795|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727796|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727797|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727798|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727799|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727800|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727801|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727802|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727803|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727804|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727805|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727806|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727819|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727820|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727821|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727822|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727823|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727824|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727825|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727826|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727827|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727828|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727829|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727830|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727831|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727832|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727833|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727834|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727835|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727836|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727837|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727838|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727839|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727840|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727841|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727842|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727843|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727844|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727845|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727846|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727847|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727848|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727849|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727850|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727851|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727852|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727853|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727854|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727855|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727856|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727857|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727858|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727859|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727860|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727861|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727862|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727863|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727864|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727865|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727866|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727867|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727868|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727869|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727870|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727871|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727872|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727873|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727874|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727875|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727876|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727877|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727878|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727879|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727880|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727881|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727882|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727956|NCT01704404|E1|Reported Event|Dose 1 TD-4208|"22 µg~TD-4208"
727883|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727884|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727885|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727886|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727887|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727888|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727889|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727890|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727891|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727892|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727893|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727894|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727895|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727896|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727897|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727898|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727899|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727900|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727901|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727902|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727903|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727904|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727905|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727906|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727907|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727908|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727909|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727910|NCT01704495|O4|Outcome|Placebo|Placebo oral capsules self-administred twice daily
727911|NCT01704495|O3|Outcome|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727912|NCT01704495|O2|Outcome|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727913|NCT01704495|O1|Outcome|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727914|NCT01704495|E4|Reported Event|Placebo|Placebo oral capsules self-administered twice daily
727915|NCT01704495|E3|Reported Event|AZD5069 5 mg BID|AZD5069 oral capsules self-administered twice daily
727916|NCT01704495|E2|Reported Event|AZD5069 15 mg BID|AZD5069 oral capsules self-administered twice daily
727917|NCT01704495|E1|Reported Event|AZD5069 45 mg BID|AZD5069 oral capsules self-administered twice daily
727918|NCT01704404|B1|Baseline|Entire Study Population|"All subjects received Placebo and 4 of 6 TD-4208 dose levels:~TD-4208 - 22 µg TD-4208 - 44 µg TD-4208 - 88 µg TD-4208 - 175 µg TD-4208 - 350 µg TD-4208 - 700 µg"
727919|NCT01704404|P6|Participant Flow|Treatment 6|Placebo, 44 µg, 88 µg, 175 µg, 350 µg
727920|NCT01704404|P5|Participant Flow|Treatment 5|22 µg, 44 µg, 175 µg, 350 µg
727921|NCT01704404|P4|Participant Flow|Treatment 4|22 µg, 44 µg, 175 µg, 700 µg
727922|NCT01704404|P3|Participant Flow|Treatment 3|Placebo, 22 µg, 88 µg, 175 µg, 700 µg
727923|NCT01704404|P2|Participant Flow|Treatment 2|Placebo, 22 µg, 88 µg, 350 µg, 700 µg
727924|NCT01704404|P1|Participant Flow|Treatment 1|Placebo, 44 µg, 88 µg, 350 µg, 700 µg
727925|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
727926|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
727927|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
727928|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
727929|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
727930|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
727931|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
727932|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
727933|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
727934|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
727935|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
727936|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
727937|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
727938|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
727939|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
727940|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
727941|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
727942|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
727943|NCT01704404|O7|Outcome|Placebo|"Placebo~Placebo"
727944|NCT01704404|O6|Outcome|Dose 6 TD-4208|"700 µg~TD-4208"
727945|NCT01704404|O5|Outcome|Dose 5 TD-4208|"350 µg~TD-4208"
727946|NCT01704404|O4|Outcome|Dose 4 TD-4208|"175 µg~TD-4208"
727947|NCT01704404|O3|Outcome|Dose 3 TD-4208|"88 µg~TD-4208"
727948|NCT01704404|O2|Outcome|Dose 2 TD-4208|"44 µg~TD-4208"
727949|NCT01704404|O1|Outcome|Dose 1 TD-4208|"22 µg~TD-4208"
727950|NCT01704404|E7|Reported Event|Placebo|"Placebo~Placebo"
727951|NCT01704404|E6|Reported Event|Dose 6 TD-4208|"700 µg~TD-4208"
727952|NCT01704404|E5|Reported Event|Dose 5 TD-4208|"350 µg~TD-4208"
727953|NCT01704404|E4|Reported Event|Dose 4 TD-4208|"175 µg~TD-4208"
727958|NCT01704287|B3|Baseline|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
727959|NCT01704287|B2|Baseline|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727960|NCT01704287|B1|Baseline|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727961|NCT01704287|P5|Participant Flow|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
727962|NCT01704287|P4|Participant Flow|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed progressive disease (PD) and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
727963|NCT01704287|P3|Participant Flow|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
727964|NCT01704287|P2|Participant Flow|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727965|NCT01704287|P1|Participant Flow|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg intravenously (IV) every 3 weeks (Q3W).
727966|NCT01704287|O5|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
727967|NCT01704287|O4|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
727968|NCT01704287|O3|Outcome|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
727969|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727970|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727999|NCT01704261|B1|Baseline|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
727971|NCT01704287|O5|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
727972|NCT01704287|O4|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
727973|NCT01704287|O3|Outcome|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
727974|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727975|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727976|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
727977|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727978|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727979|NCT01704287|O2|Outcome|ICC→Pembrolizumab 10 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 10 mg/kg IV Q3W.
727980|NCT01704287|O1|Outcome|ICC→Pembrolizumab 2 mg/kg|Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg or 10 mg/kg in a double-blind fashion. Participants who qualified to switch to pembrolizumab, must have completed a washout period of ≥28 days from last dose of chemotherapy before receiving pembrolizumab. Participants received pembrolizumab 2 mg/kg IV Q3W.
727981|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
727982|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727983|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727984|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
727985|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727986|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727987|NCT01704287|O3|Outcome|Investigator-Choice Chemotherapy (ICC)|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide).
727988|NCT01704287|O2|Outcome|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727989|NCT01704287|O1|Outcome|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727990|NCT01704287|E7|Reported Event|ICC (After Switch to Pembrolizumab 10 mg/kg)|Participants initially received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide), experienced confirmed PD, met all crossover criteria at study treatment Week 12, and switched to receive pembrolizumab 10 mg/kg. These events occurred while these participants were receiving pembrolizumab 10 mg/kg after switching from ICC.
727991|NCT01704287|E6|Reported Event|ICC (After Switch to Pembrolizumab 2 mg/kg)|Participants initially received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide), experienced confirmed PD, met all crossover criteria at study treatment Week 12, and switched to receive pembrolizumab 2 mg/kg. These events occurred while these participants were receiving pembrolizumab 2 mg/kg after switching from ICC.
727992|NCT01704287|E5|Reported Event|Pembrolizumab 10 mg/kg|Participants received pembrolizumab 10 mg/kg IV Q3W.
727993|NCT01704287|E4|Reported Event|Pembrolizumab 2 mg/kg|Participants received pembrolizumab 2 mg/kg IV Q3W.
727994|NCT01704287|E3|Reported Event|ICC (Before Switch to Pembrolizumab 10 mg/kg)|Participants received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 10 mg/kg. These events occurred while these participants were receiving ICC prior to switching.
727995|NCT01704287|E2|Reported Event|ICC (Before Switch to Pembrolizumab 2 mg/kg)|Participants received one of four possible chemotherapy regimens (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). Participants who were assigned to ICC, experienced confirmed PD and met all crossover criteria at study treatment Week 12, had the opportunity to switch to receive pembrolizumab 2 mg/kg. These events occurred while these participants were receiving ICC prior to switching.
727996|NCT01704287|E1|Reported Event|ICC Only|Participants received one of four possible chemotherapy regimens decided at the treating institution (carboplatin + paclitaxel, paclitaxel alone, dacarbazine, or temozolomide). This treatment group included the participants who remained on ICC through the database cutoff date.
727997|NCT01704261|B3|Baseline|Total|Total of all reporting groups
727998|NCT01704261|B2|Baseline|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728000|NCT01704261|P2|Participant Flow|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728001|NCT01704261|P1|Participant Flow|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728002|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728003|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728004|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728005|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728006|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728007|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728008|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728088|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
728009|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728010|NCT01704261|O2|Outcome|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728011|NCT01704261|O1|Outcome|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728012|NCT01704261|E2|Reported Event|Placebo|Matching placebo to omarigliptin capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728013|NCT01704261|E1|Reported Event|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week for 24 weeks. Participants continue pre-study concomitant therapy of open-label glimepiride tablet(s) orally once daily (total daily dose >=4 mg per day) and metformin tablet(s) orally once or twice daily (total daily dose >=1500 mg per day).
728014|NCT01704196|B3|Baseline|Total|Total of all reporting groups
728015|NCT01704196|B2|Baseline|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
728016|NCT01704196|B1|Baseline|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
728017|NCT01704196|P2|Participant Flow|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
728018|NCT01704196|P1|Participant Flow|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
728019|NCT01704196|O2|Outcome|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
728020|NCT01704196|O1|Outcome|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
728021|NCT01704196|O2|Outcome|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
728022|NCT01704196|O1|Outcome|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
728023|NCT01704196|E2|Reported Event|Placebo|"Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks.~Placebo"
728024|NCT01704196|E1|Reported Event|Nepicastat|"Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks~Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks."
728025|NCT01704079|B3|Baseline|Total|Total of all reporting groups
728050|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728051|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728026|NCT01704079|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728027|NCT01704079|B1|Baseline|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728028|NCT01704079|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728029|NCT01704079|P1|Participant Flow|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728030|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728031|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728032|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728033|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728034|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728035|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728036|NCT01704079|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728037|NCT01704079|O1|Outcome|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728038|NCT01704079|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728039|NCT01704079|E1|Reported Event|Sugar Pill to CTAP101 30 μg|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
728040|NCT01703988|B5|Baseline|Total|Total of all reporting groups
728041|NCT01703988|B4|Baseline|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728042|NCT01703988|B3|Baseline|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728043|NCT01703988|B2|Baseline|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728044|NCT01703988|B1|Baseline|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
728045|NCT01703988|P4|Participant Flow|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728046|NCT01703988|P3|Participant Flow|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728047|NCT01703988|P2|Participant Flow|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728048|NCT01703988|P1|Participant Flow|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, intrathecal (IT) injection
728049|NCT01703988|O1|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728052|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728053|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
728054|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728055|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728056|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728057|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
728058|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728059|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728060|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728061|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
728062|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728063|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728064|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728065|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
728066|NCT01703988|O4|Outcome|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728067|NCT01703988|O3|Outcome|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728068|NCT01703988|O2|Outcome|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728069|NCT01703988|O1|Outcome|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
728070|NCT01703988|E4|Reported Event|Nusinersen 12 mg|12 mg nusinersen on Days 1, 29, 85, IT injection
728071|NCT01703988|E3|Reported Event|Nusinersen 9 mg|9 mg nusinersen on Days 1 and 85, IT injection
728072|NCT01703988|E2|Reported Event|Nusinersen 6 mg|6 mg nusinersen on Days 1, 29, 85, IT injection
728073|NCT01703988|E1|Reported Event|Nusinersen 3 mg|3 mg nusinersen on Days 1, 29, 85, IT injection
728074|NCT01703858|B4|Baseline|Total|Total of all reporting groups
728089|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
728090|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
728091|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
728075|NCT01703858|B3|Baseline|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
728076|NCT01703858|B2|Baseline|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
728077|NCT01703858|B1|Baseline|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
728078|NCT01703858|P3|Participant Flow|C - B - A - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) and then the oral solution of BI-113608 (50 mg) under fasted conditions (A) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
728079|NCT01703858|P2|Participant Flow|B - A - C - D - E|Participants first received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B), then they received oral solution of BI-113608 (50 mg) under fasted conditions (A) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 h prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 min prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
728109|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728110|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728080|NCT01703858|P1|Participant Flow|A - C - B - D - E|Participants first received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions (A), then they received conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions (C) and then the conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions (B) in 3-way crossover periods with washout phase of at least 6 days. After this participants received conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608 (D) and then conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast (E). All doses were administered orally.
728081|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
728082|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
728083|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
728084|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
728085|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
728086|NCT01703858|O5|Outcome|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
728087|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
728558|NCT01702233|B3|Baseline|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728092|NCT01703858|O4|Outcome|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
728093|NCT01703858|O3|Outcome|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
728094|NCT01703858|O2|Outcome|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
728095|NCT01703858|O1|Outcome|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
728096|NCT01703858|E6|Reported Event|E : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally 30 minutes (min) prior to a standardized high-calorie, high-fat breakfast.
728097|NCT01703858|E5|Reported Event|D : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally following administration of pantoprazole 40 mg twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
728098|NCT01703858|E4|Reported Event|Pantoprazole 40mg|Participants received single dose of Pantoprazole 40mg alone twice daily for 4 days with an additional 40 mg of pantoprazole 2 hours (h) prior to administration of BI-113608.
728099|NCT01703858|E3|Reported Event|C : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fed conditions orally.
728100|NCT01703858|E2|Reported Event|B : BI-113608|Participants received single dose of conventional tablet of BI-113608 (2 tablets of 25 mg) under fasted conditions orally.
728101|NCT01703858|E1|Reported Event|A : BI-113608|Participants received single dose of oral solution of BI-113608 (50 milligram (mg)) under fasted conditions.
728102|NCT01703845|B3|Baseline|Total|Total of all reporting groups
728103|NCT01703845|B2|Baseline|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728104|NCT01703845|B1|Baseline|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728105|NCT01703845|P2|Participant Flow|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728106|NCT01703845|P1|Participant Flow|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728107|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728108|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728111|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728112|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728113|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728114|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728115|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728116|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728117|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728118|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728119|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728120|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728121|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728212|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
728122|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728123|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC).The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728124|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728125|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728126|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728127|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728128|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728129|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728130|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728131|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728132|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728133|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728134|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728135|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728196|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728679|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728136|NCT01703845|O2|Outcome|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728137|NCT01703845|O1|Outcome|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728138|NCT01703845|E2|Reported Event|Tiotropium + Olodaterol (2.5µg/5µg)|Oral inhalation of tiotropium 2.5 microgram (µg) (low dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728139|NCT01703845|E1|Reported Event|Tiotropium + Olodaterol (5µg/5µg)|Oral inhalation of tiotropium 5 microgram (µg) (high dose) + olodaterol solution 5µg fixed-dose combination (FDC). The patients inhale 2 puffs from the RESPIMAT inhaler, once a day, in the morning up to 3 weeks.
728140|NCT01703832|B3|Baseline|Total|Total of all reporting groups
728141|NCT01703832|B2|Baseline|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728142|NCT01703832|B1|Baseline|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728143|NCT01703832|P2|Participant Flow|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728144|NCT01703832|P1|Participant Flow|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728145|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728213|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
730016|NCT01694667|E1|Reported Event|Omega-3|Participants randomized to omega-3
728146|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728147|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728148|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728149|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728150|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728151|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728152|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728153|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728154|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728155|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728156|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728157|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728158|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728159|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728160|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728161|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728162|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728163|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728164|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728165|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728166|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728167|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728168|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728169|NCT01703832|O2|Outcome|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728170|NCT01703832|O1|Outcome|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728171|NCT01703832|E2|Reported Event|No Intervention|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) underwent natural course, i.e. no tablet intake or other therapeutic intervention.
728172|NCT01703832|E1|Reported Event|Neurexan®|At baseline, healthy male or female participants with an age of between 31 to 59 years and the ability to understand the explanations and instructions given by the study physician (fluency in German) took a total of 6 tablets of Neurexan over a period of 2.5 hours.
728173|NCT01703819|B3|Baseline|Total|Total of all reporting groups
728174|NCT01703819|B2|Baseline|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728175|NCT01703819|B1|Baseline|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to~-30 minutes~Neurexan®"
728176|NCT01703819|P2|Participant Flow|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728177|NCT01703819|P1|Participant Flow|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728178|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728179|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728180|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728181|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728182|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728183|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728184|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728185|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728186|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728187|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728188|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728189|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728190|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728191|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728192|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728193|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728194|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728195|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728197|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728198|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728199|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728200|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728201|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728202|NCT01703819|O2|Outcome|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728203|NCT01703819|O1|Outcome|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728204|NCT01703819|E2|Reported Event|Placebo|"6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Placebo"
728205|NCT01703819|E1|Reported Event|Neurexan®|"0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes~Neurexan®"
728206|NCT01703702|B3|Baseline|Total|Total of all reporting groups
728207|NCT01703702|B2|Baseline|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
728208|NCT01703702|B1|Baseline|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
728209|NCT01703702|P2|Participant Flow|Control|"Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
728210|NCT01703702|P1|Participant Flow|Intervention|"Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.~florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration"
728211|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
730017|NCT01694641|B3|Baseline|Total|Total of all reporting groups
728214|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
728215|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
728216|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
728217|NCT01703702|O2|Outcome|Control Scan/Diagnosis Concordant|Control arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
728218|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Concordant|Intervention arm patients whose florbetapir F18 PET scan results were predicted by their initial diagnosis
728219|NCT01703702|O2|Outcome|Control Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their initial diagnosis
728220|NCT01703702|O1|Outcome|Intervention Scan/Diagnosis Discordant|Intervention arm patients whose florbetapir F18 PET scan results were not predicted by their baseline clinical diagnosis.
728221|NCT01703702|O2|Outcome|Mild Impairment AB-|Patients diagnosed with a cognitive status of mild impairment and AB- scan result.
728222|NCT01703702|O1|Outcome|Mild Impairment AB+|Patients diagnosed with a cognitive status of mild impairment and AB+ scan result.
728223|NCT01703702|O2|Outcome|Control|Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months
728224|NCT01703702|O1|Outcome|Intervention|Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.
728225|NCT01703702|E1|Reported Event|Safety Population|620 patients received florbetapir (18F) and comprise the Safety Population.
728226|NCT01703663|B1|Baseline|All Participants|
728227|NCT01703663|P2|Participant Flow|Control Night First Night, EPAP Therapy Second Night|During the first night, the subject was assigned to no EPAP (control night). During the second night, the subject was assigned to wear EPAP. During both nights, sleep disordered breathing was monitored with the WatchPAT device.
728228|NCT01703663|P1|Participant Flow|EPAP Therapy First Night, Then Control Night|During the first night, the subject was assigned to wear EPAP. During the second night, the subject did not wear EPAP (control night). During both nights, sleep disordered breathing was monitored with the WatchPAT device.
728229|NCT01703663|O2|Outcome|Control Night|Raw data from control night (not taking into account period effect).
728230|NCT01703663|O1|Outcome|EPAP Night|Raw data from EPAP night (not taking into account period effect).
728231|NCT01703663|E2|Reported Event|Control Night|
728232|NCT01703663|E1|Reported Event|EPAP Night|
728233|NCT01703286|B1|Baseline|Total Participants|All study participants
728234|NCT01703286|P6|Participant Flow|L 5/ Pbo/ G1-4/|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
728235|NCT01703286|P5|Participant Flow|Pbo/ L 5/ G1-4|Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
728236|NCT01703286|P4|Participant Flow|G1-4/ Pbo/ L 5|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
728237|NCT01703286|P3|Participant Flow|G 1-4/ L 5/ Pbo|Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days/ Placebo tablet once daily over 28 days
728238|NCT01703286|P2|Participant Flow|L 5/ G 1-4/ Pbo|Linagliptin 1 tablet (5 mg) once daily for 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Placebo tablet once daily over 28 days
728239|NCT01703286|P1|Participant Flow|Pbo/ G1-4/ L 5|Placebo tablet once daily over 28 days/ Glimepiride 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days/ Linagliptin 1 tablet (5 mg) once daily for 28 days
728240|NCT01703286|O6|Outcome|Rep - Placebo|Residual effect period - Placebo
728241|NCT01703286|O5|Outcome|REP - Glimepiride 1-4 mg|Residual effect period - Glimepiride 1-4 mg
728242|NCT01703286|O4|Outcome|REP - Linagliptin 5 mg|Residual effect period - Linagliptin 5 mg
728243|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
728244|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
728245|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
728246|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
728247|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
728248|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
728249|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
728250|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
728251|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
728252|NCT01703286|O3|Outcome|Placebo|Placebo: matching Linagliptin or Glimepiride tablet once daily over 28 days
728253|NCT01703286|O2|Outcome|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
728254|NCT01703286|O1|Outcome|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
728255|NCT01703286|E3|Reported Event|Placebo|Placebo: matching Linagliptin or Glimepiride given once daily over 28 days
728256|NCT01703286|E2|Reported Event|Glimepiride 1-4 mg|Glimepiride: 1 tablet (1 mg) once daily for 7 days followed by uptitration to 2 to 4 mg once daily within next 21 days
728257|NCT01703286|E1|Reported Event|Linagliptin 5 mg|Linagliptin: 1 tablet (5 mg) once daily for 28 days
728258|NCT01703260|B4|Baseline|Total|Total of all reporting groups
728259|NCT01703260|B3|Baseline|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728260|NCT01703260|B2|Baseline|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728261|NCT01703260|B1|Baseline|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728262|NCT01703260|P3|Participant Flow|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728263|NCT01703260|P2|Participant Flow|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728264|NCT01703260|P1|Participant Flow|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728265|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728266|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728267|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728268|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728269|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728270|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728271|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728272|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728273|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728274|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728275|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728276|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728277|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728278|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728279|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728761|NCT01701245|E1|Reported Event|Standard of Care|No intervention, standard of care
728280|NCT01703260|O3|Outcome|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728281|NCT01703260|O2|Outcome|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728282|NCT01703260|O1|Outcome|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728283|NCT01703260|E3|Reported Event|Pioglitazone Only|Pioglitazone, 30 mg, tablet, orally, once daily and roflumilast placebo-matching tablet, orally, once daily for up to 4 months.
728284|NCT01703260|E2|Reported Event|Roflumilast Only|Roflumilast, 500 mcg, tablet, orally, once daily and pioglitazone placebo-matching tablet, orally, once daily for up to 4 months.
728285|NCT01703260|E1|Reported Event|Roflumilast + Pioglitazone|Roflumilast, 500 microgram (mcg), tablet, orally, once daily and pioglitazone, 30 milligram (mg), tablet, orally, once daily for up to 4 months.
728286|NCT01703221|B4|Baseline|Total|Total of all reporting groups
728287|NCT01703221|B3|Baseline|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
728288|NCT01703221|B2|Baseline|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
728289|NCT01703221|B1|Baseline|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
728290|NCT01703221|P3|Participant Flow|Placebo (Phase A) Switching to Omarigliptin (Phase B)|Placebo for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
728291|NCT01703221|P2|Participant Flow|Sitagliptin (Phase A) Switching to Omarigliptin (Phase B)|Sitagliptin 50 mg once daily for 24 weeks (Phase A) switching to omarigliptin 25 mg once weekly for 28 weeks (Phase B)
728292|NCT01703221|P1|Participant Flow|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
728293|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
728294|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
728295|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
728296|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
728297|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
728298|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
728299|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
728300|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
728301|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
728302|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
728303|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
728304|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
728305|NCT01703221|O3|Outcome|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
728306|NCT01703221|O2|Outcome|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
728307|NCT01703221|O1|Outcome|Omarigliptin (Phase A+B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
728308|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
728309|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
728310|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
728311|NCT01703221|O3|Outcome|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
728312|NCT01703221|O2|Outcome|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
728313|NCT01703221|O1|Outcome|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
728314|NCT01703221|E6|Reported Event|Omarigliptin (Phase B)-P|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from placebo
728315|NCT01703221|E5|Reported Event|Omarigliptin (Phase B)-S|Omarigliptin 25 mg once weekly for 28 weeks (Phase B) after switching from sitagliptin
728316|NCT01703221|E4|Reported Event|Omarigliptin (Phase A + B)|Omarigliptin 25 mg once weekly for 52 weeks (Phase A + B)
728317|NCT01703221|E3|Reported Event|Placebo (Phase A)|Placebo for 24 weeks (Phase A)
728318|NCT01703221|E2|Reported Event|Sitagliptin (Phase A)|Sitagliptin 50 mg once daily for 24 weeks (Phase A)
728319|NCT01703221|E1|Reported Event|Omarigliptin (Phase A)|Omarigliptin 25 mg once weekly for 24 weeks (Phase A)
728320|NCT01703091|B3|Baseline|Total|Total of all reporting groups
728321|NCT01703091|B2|Baseline|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728322|NCT01703091|B1|Baseline|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728323|NCT01703091|P2|Participant Flow|Placebo Plus Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728324|NCT01703091|P1|Participant Flow|Ramucirumab Plus Docetaxel|Ramucirumab 10 milligrams/kilogram (mg/kg) administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 milligrams/square meter (mg/m2) administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728325|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728762|NCT01701102|B5|Baseline|Total|Total of all reporting groups
728326|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728327|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728328|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728329|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728330|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728331|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728332|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728333|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728334|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728335|NCT01703091|O2|Outcome|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728336|NCT01703091|O1|Outcome|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728337|NCT01703091|E2|Reported Event|Placebo + Docetaxel|Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728338|NCT01703091|E1|Reported Event|Ramucirumab + Docetaxel|Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.
728339|NCT01703000|B1|Baseline|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728340|NCT01703000|P1|Participant Flow|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728341|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728342|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728343|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728344|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728345|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728346|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728347|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728348|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728349|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728350|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728351|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728352|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728353|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728354|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728355|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728356|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728357|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728358|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728359|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728360|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728361|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728362|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728363|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728364|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728365|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728366|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728367|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728368|NCT01703000|O1|Outcome|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728369|NCT01703000|E1|Reported Event|NG PROMUS Stent|"Single-arm treatment group receiving interventional NG PROMUS study stent~Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent."
728370|NCT01702987|B3|Baseline|Total|Total of all reporting groups
728371|NCT01702987|B2|Baseline|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
728372|NCT01702987|B1|Baseline|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
728373|NCT01702987|P2|Participant Flow|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
728374|NCT01702987|P1|Participant Flow|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
728375|NCT01702987|O2|Outcome|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
728376|NCT01702987|O1|Outcome|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
728377|NCT01702987|E2|Reported Event|Statin + Placebo|"9 patients taking statin medications and placebo.~placebo: placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients~statin: statin was given for 1 month to 21 patients"
728378|NCT01702987|E1|Reported Event|Statin + Ubiquinol|"12 patients on statins and ubiquinol~ubiquinol: ubiquinol supplementation was given for 1 month to 12 patients~statin: statin was given for 1 month to 21 patients"
728379|NCT01702961|B1|Baseline|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
728380|NCT01702961|P1|Participant Flow|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
728381|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
730553|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
728382|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
728383|NCT01702961|O1|Outcome|BEAM + R: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
728384|NCT01702961|E1|Reported Event|Rituxan+BEAM: Autologous Stem Cell Transplant|"Ara-C, VP-16, BCNU, Melphalan, Rituxan and Stem Cells BEAM Conditioning.~BEAM Conditioning.~Melphalan: Given on Day -1~Melphalan is administered according to the current SOP.~Ara-C: 200 mg/m2 IB BID given on Days -5, -4, -3, -2~VP-16: 200 mg/m2 IV BID given on Days -5, -4, -3, -2~BCNU: BCNU 300 mg/m2 IV given on Day -6~Rituxan: 375 mg/m2 IB given on Days -6, +14, +21, +28~Stem Cells: Stem cells given on Day 0"
728385|NCT01702532|B3|Baseline|Total|Total of all reporting groups
728386|NCT01702532|B2|Baseline|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
728387|NCT01702532|B1|Baseline|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
728388|NCT01702532|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
728389|NCT01702532|P1|Participant Flow|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
728390|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes).
728391|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
730202|NCT01692782|B3|Baseline|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
728392|NCT01702532|O2|Outcome|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 – 30 minutes)
728393|NCT01702532|O1|Outcome|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
728394|NCT01702532|E2|Reported Event|Nicotine Lozenge 2 mg|Participants received a single dose of 2 mg nicotine lozenge to be placed into the mouth and periodically moved from one side of mouth to other, without swallowing until lozenge dissolved (approximately 20 to 30 minutes).
728395|NCT01702532|E1|Reported Event|Nicotine Mouth Film 2.5 mg|Participants received a single dose of 2.5 mg nicotine mouth film placed on the top of tongue and pressed to the roof of mouth until film dissolved (approximately 2 to 3 minutes).
728396|NCT01702519|B3|Baseline|Total|Total of all reporting groups
728397|NCT01702519|B2|Baseline|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
728398|NCT01702519|B1|Baseline|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
728399|NCT01702519|P2|Participant Flow|Reference Then Test Patch|Participants first applied the Reference nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied the Test nicotine patch containing reference adhesive (21 mg) for additional 24 hours.
728400|NCT01702519|P1|Participant Flow|Test Then Reference Patch|Participants first applied a test nicotine patch (21 mg) containing test adhesive for 24 hours, and then entered a washout period of 48 hours. Post-washout, they applied reference nicotine patch containing Reference adhesive (21 mg) for additional 24 hours.
728401|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
728402|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
728403|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
728404|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
728405|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours.
728406|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
728407|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with reference adhesive, for 24 hours
728408|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours
728409|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
728410|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
728411|NCT01702519|O2|Outcome|Reference Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with the reference adhesive, for 24 hours.
728412|NCT01702519|O1|Outcome|Test Patch|Participants were instructed to wear transdermal nicotine patch (21 mg) with test adhesive, for 24 hours.
728413|NCT01702519|E2|Reported Event|Reference Patch|Participants were instructed to wear transdermal nicotine patch with reference adhesive, for 24 hours
728414|NCT01702519|E1|Reported Event|Test Patch|Participants were instructed to wear transdermal nicotine patch with test adhesive, for 24 hours.
728415|NCT01702454|B3|Baseline|Total|Total of all reporting groups
728416|NCT01702454|B2|Baseline|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728417|NCT01702454|B1|Baseline|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728418|NCT01702454|P2|Participant Flow|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728419|NCT01702454|P1|Participant Flow|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728420|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|SuSubjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728421|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728422|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728521|NCT01702298|P1|Participant Flow|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728423|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728424|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728425|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728426|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728427|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728428|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728429|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728430|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728431|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728432|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728433|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728434|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728435|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728436|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728437|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728438|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728439|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
728440|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728441|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728442|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728443|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728444|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728445|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728446|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728447|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728448|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728449|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728450|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728451|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
728452|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728453|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728454|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728455|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm
728456|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728457|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728458|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728459|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728460|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728461|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728462|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728463|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728464|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728465|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728466|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728467|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728468|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728469|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728470|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728471|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728472|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728473|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728474|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728475|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728476|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728477|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728478|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728479|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728480|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728481|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728482|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728483|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NC T01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728484|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728485|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728486|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728487|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728488|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728489|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728490|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728491|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728492|NCT01702454|O2|Outcome|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728493|NCT01702454|O1|Outcome|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728494|NCT01702454|E2|Reported Event|Fluarix Quadrivalent Unprimed Group|Subjects in this group were unprimed in the primary study 115345 (NCT01439360) and received 2 doses of Fluarix Quadrivalent vaccine at Days 0 and 28 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728495|NCT01702454|E1|Reported Event|Fluarix Quadrivalent Primed Group|Subjects in this group were previously primed with 2 doses of Fluarix Quadrivalent vaccine in the primary study 115345 (NCT01439360) and received 1 dose of Fluarix Quadrivalent vaccine at Day 0 in the current study. The vaccine was administered intramuscularly in the deltoid region of arm.
728496|NCT01702363|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728497|NCT01702363|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
728498|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728499|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728500|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728501|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728502|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728503|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728504|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728505|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728506|NCT01702363|O1|Outcome|MEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728507|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728508|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728509|NCT01702363|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728510|NCT01702363|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD in the morning via a DPI for 52 weeks.
728511|NCT01702311|B3|Baseline|Total|Total of all reporting groups
728590|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728512|NCT01702311|B2|Baseline|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
728513|NCT01702311|B1|Baseline|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
728514|NCT01702311|P2|Participant Flow|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
728515|NCT01702311|P1|Participant Flow|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
728516|NCT01702311|O2|Outcome|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
728517|NCT01702311|O1|Outcome|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
728518|NCT01702311|E2|Reported Event|No Bedtime Supplementation|Patients in this arm will have ac (before meals), qhs (bedtime), and 3 am blood glucose testing; however, subjects in this group will NOT receive sliding scale insulin bedtime supplementation.
728519|NCT01702311|E1|Reported Event|Bedtime Supplementation|"Patients in this arm will have acqhs (before meals and at bedtime) and 3 am blood glucose testing and will receive sliding scale insulin supplementation as needed.~Bedtime insulin Aspart (Novolog): Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm."
728520|NCT01702298|B1|Baseline|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728522|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728523|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728524|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728525|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728526|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728527|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728528|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728529|NCT01702298|O1|Outcome|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728530|NCT01702298|E1|Reported Event|Sitagliptin 100 mg/Simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC once daily in the evening for 6 weeks. Participants continued on their pre-study dose of metformin (>=1000 mg per day).
728531|NCT01702259|B3|Baseline|Total|Total of all reporting groups
728532|NCT01702259|B2|Baseline|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728533|NCT01702259|B1|Baseline|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
728534|NCT01702259|P2|Participant Flow|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728535|NCT01702259|P1|Participant Flow|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light."
728536|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728537|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
728538|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728539|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
728540|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728591|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728541|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
728542|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728543|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
728544|NCT01702259|O2|Outcome|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728545|NCT01702259|O1|Outcome|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
728546|NCT01702259|E2|Reported Event|Placebo Device|"Inactive Erchonia GLS device~Placebo device: Inactive Erchonia GLS."
728547|NCT01702259|E1|Reported Event|Erchonia Scanner Device (GLS)|"The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light.~Erchonia Scanner device (GLS): The Erchonia® GLS device is made up of six independent diodes, each emitting 17 mW, 532 nanometer of green laser light."
728548|NCT01702246|B1|Baseline|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
728549|NCT01702246|P1|Participant Flow|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
728550|NCT01702246|O2|Outcome|Simvastatin Treatment|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
728551|NCT01702246|O1|Outcome|Baseline Cholesterol|mean cholesterol level (mmol/L) prior to treatment with simvastatin
728552|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
728553|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
728554|NCT01702246|O2|Outcome|Simvastatin|after treatment with simvastatin: 40 mg, orally, once daily for 3 months
728555|NCT01702246|O1|Outcome|Baseline|prior to treatment with simvastatin
728556|NCT01702246|E1|Reported Event|Simvastatin|"Simvastatin (Zocor), 40mg tablet, 40mg orally once daily, for 3 months~Simvastatin: 40 mg, orally, once daily for 3 months"
728557|NCT01702233|B4|Baseline|Total|Total of all reporting groups
728559|NCT01702233|B2|Baseline|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728560|NCT01702233|B1|Baseline|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728561|NCT01702233|P3|Participant Flow|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728562|NCT01702233|P2|Participant Flow|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728563|NCT01702233|P1|Participant Flow|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728564|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728565|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728566|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728567|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728568|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728569|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728570|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728571|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728572|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728573|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728574|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728575|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728576|NCT01702233|O3|Outcome|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728577|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728578|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728579|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728580|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728581|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728582|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728583|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728584|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728585|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728586|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728587|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728588|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728589|NCT01702233|O2|Outcome|Saline Inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728592|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728593|NCT01702233|O2|Outcome|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728594|NCT01702233|O1|Outcome|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728595|NCT01702233|E3|Reported Event|Saline Inj.|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728596|NCT01702233|E2|Reported Event|Fortecortin/Dexamethasone 8 mg Inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
728597|NCT01702233|E1|Reported Event|Traumeel S Inj.|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
728598|NCT01702025|B5|Baseline|Total|Total of all reporting groups
728599|NCT01702025|B4|Baseline|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
728600|NCT01702025|B3|Baseline|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
728601|NCT01702025|B2|Baseline|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
728602|NCT01702025|B1|Baseline|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
728603|NCT01702025|P4|Participant Flow|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
728604|NCT01702025|P3|Participant Flow|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide: Hypoxia
728605|NCT01702025|P2|Participant Flow|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
728606|NCT01702025|P1|Participant Flow|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo: Hypoxia
728607|NCT01702025|O8|Outcome|Hypoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose hypoxia
728608|NCT01702025|O7|Outcome|Normoxia Methazolamide/Aminophylline|Methazolamide combined with Aminophylline: single dose normoxia
728609|NCT01702025|O6|Outcome|Hypoxia Methazolamide|Methazolamide: single dose hypoxia
728610|NCT01702025|O5|Outcome|Normoxia Methazolamide|Methazolamide single dose Normoxia
728611|NCT01702025|O4|Outcome|Hypoxia Aminophylline|Aminophylline:single dose hypoxia
728612|NCT01702025|O3|Outcome|Normoxia Aminophylline|Aminophylline:single dose Normoxia
728613|NCT01702025|O2|Outcome|Hypoxia Placebo|Placebo: single dose hypoxia
728614|NCT01702025|O1|Outcome|Normoxia Placebo|Placebo: single dose Normoxia
728837|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
728615|NCT01702025|E4|Reported Event|Aminophylline + Methazolamide|Single dose Aminophylline+Methazolamide Normoxia Minimum 7 day washout Single dose Aminophylline+Methazolamide: Hypoxia
728616|NCT01702025|E3|Reported Event|Methazolamide|Single dose Methazolamide Normoxia Minimum 7 day washout Single dose Methazolamide Hypoxia
728617|NCT01702025|E2|Reported Event|Aminophylline|Single dose Aminophylline Normoxia Minimum 7 day washout Single dose Aminophylline Hypoxia
728618|NCT01702025|E1|Reported Event|Placebo|Single dose Placebo Normoxia Minimum 7 day washout Single dose placebo Hypoxia
728619|NCT01701999|B3|Baseline|Total|Total of all reporting groups
728620|NCT01701999|B2|Baseline|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
728621|NCT01701999|B1|Baseline|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
728622|NCT01701999|P2|Participant Flow|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
728623|NCT01701999|P1|Participant Flow|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
728624|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
728625|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
728626|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
728627|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
728628|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
728629|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
728630|NCT01701999|O2|Outcome|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
728631|NCT01701999|O1|Outcome|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
728632|NCT01701999|E2|Reported Event|Safety, Immunogenicity, and Plasma Collection (Part 2)|Part 2 was conducted to collect source plasma for potential use in the production of BabyBIG® and to assess safety and immunogenicity of a single 40 µg dose of over a 12-week period; Part 2 included a follow-up for safety assessment at 6 months. Participants in Part 2 did not participate in Part 1.
728633|NCT01701999|E1|Reported Event|Initial Safety and Immunogenicity (Part 1)|Part 1 included scheduled assessments of the safety and immunogenicity of a single 40 µg dose of rBV A/B over a 12-week period with a safety follow-up at 6 months.
728634|NCT01701674|B1|Baseline|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
728635|NCT01701674|P1|Participant Flow|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
728636|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
728637|NCT01701674|O1|Outcome|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
728638|NCT01701674|E1|Reported Event|Experimental: Combination Therapy|The combination of ipilimumab followed by lymphodepletion with chemotherapy, TIL infusion, and high dose IL-2.
728639|NCT01701622|B1|Baseline|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
728640|NCT01701622|P1|Participant Flow|Allopurinol, Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
728694|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728641|NCT01701622|O2|Outcome|Febuxostat|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
728642|NCT01701622|O1|Outcome|Allopurinol|"Patients currently treated with allopurinol will be switched to febuxostat, and the blood pressure differences between the two arms will be compared.~febuxostat : If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
728643|NCT01701622|E1|Reported Event|Febuxostat|Febuxostat group. The primary outcome of the study is the 24 hour ABPM differences while participants were taking allopurinol compared to taking febuxostat.
728644|NCT01701414|B3|Baseline|Total|Total of all reporting groups
728645|NCT01701414|B2|Baseline|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
728646|NCT01701414|B1|Baseline|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
728647|NCT01701414|P2|Participant Flow|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
728648|NCT01701414|P1|Participant Flow|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
728649|NCT01701414|O2|Outcome|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
728650|NCT01701414|O1|Outcome|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
728651|NCT01701414|E2|Reported Event|Standard Care (SC)|"The SC group will receive a sham injection of normal saline in order to blind both the participants and the treating physicians. A 7.5-MHz linear transducer will be placed on the side of the affected hip 1cm below the inguinal ligament. 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice.~Placebo: 3cc of 0.9% Normal Saline : 1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice"
728695|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728696|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728697|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728838|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
728652|NCT01701414|E1|Reported Event|Femoral Nerve Block (FNB)|"Participants randomized to the second group, FNB group, will receive an Ultrasound (US) guided femoral nerve block using a Sonosite TitanTM (Sonosite, Inc., Bothell, WA) with a 7.5-MHz linear array transducer. Using this technique, 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The femoral, obturator, and lateral cutaneous nerve are anesthetized with this technique (thus the name 3-in-1 femoral block is often used), providing maximum analgesia to the hip.~Femoral nerve block: 25 mL of 0.5% bupivacaine : 25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks."
728653|NCT01701401|B5|Baseline|Total|Total of all reporting groups
728654|NCT01701401|B4|Baseline|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728655|NCT01701401|B3|Baseline|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728656|NCT01701401|B2|Baseline|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728657|NCT01701401|B1|Baseline|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728658|NCT01701401|P4|Participant Flow|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728659|NCT01701401|P3|Participant Flow|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728660|NCT01701401|P2|Participant Flow|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus ribavirin (RBV) tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728661|NCT01701401|P1|Participant Flow|LDV/SOF 12 Weeks|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet once daily for 12 weeks
728662|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728663|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728664|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728665|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728666|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728667|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728668|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728669|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728670|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728671|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728672|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728673|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728674|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728675|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728676|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728677|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728678|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728680|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728681|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728682|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728683|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728684|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728685|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728686|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728687|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728688|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728689|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728690|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728691|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728692|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728693|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728831|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
728698|NCT01701401|O4|Outcome|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728699|NCT01701401|O3|Outcome|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728700|NCT01701401|O2|Outcome|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728701|NCT01701401|O1|Outcome|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728702|NCT01701401|E4|Reported Event|LDV/SOF+RBV 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 24 weeks
728703|NCT01701401|E3|Reported Event|LDV/SOF 24 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 24 weeks
728704|NCT01701401|E2|Reported Event|LDV/SOF+RBV 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily plus RBV tablets (1000 to 1200 mg daily based on weight) in a divided daily dose for 12 weeks
728705|NCT01701401|E1|Reported Event|LDV/SOF 12 Weeks|LDV/SOF 90/400 mg FDC tablet once daily for 12 weeks
728706|NCT01701375|B1|Baseline|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
728707|NCT01701375|P1|Participant Flow|Arm 1|"PD 0332991 125 was given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
728708|NCT01701375|O1|Outcome|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
728709|NCT01701375|E1|Reported Event|Arm 1|"PD 0332991 will be given orally days 1,2,3~Cytarabine (ara-C) will be given by continuous 72 hour intravenous infusion beginning on day 6~Mitoxantrone will be given over 2 hour infusion day 9, 12 hours after the completion of the ara-C infusion. The mitoxantrone dose may be reduced by 25-50% for patients who have received previous anthracyclines as determined by total previous anthracycline dose"
728710|NCT01701362|B3|Baseline|Total|Total of all reporting groups
728711|NCT01701362|B2|Baseline|Placebo|Participants randomized to receive placebo
728712|NCT01701362|B1|Baseline|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728713|NCT01701362|P2|Participant Flow|Placebo|Participants randomized to receive placebo
728714|NCT01701362|P1|Participant Flow|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728715|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728716|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728717|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728718|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728719|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728720|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728721|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728722|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728723|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728724|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728725|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728726|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728727|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728728|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728729|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728730|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728731|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728732|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728733|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728734|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728735|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728736|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728737|NCT01701362|O2|Outcome|Placebo|Participants randomized to receive placebo
728738|NCT01701362|O1|Outcome|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728739|NCT01701362|E2|Reported Event|Placebo|Participants randomized to receive placebo
728740|NCT01701362|E1|Reported Event|Pregabalin|Participants randomized to receive pregabalin: a 3-week dose optimization phase followed by 150 mg, 300 mg, 450 mg or 600 mg per day dosing 12-week maintenance phase.
728741|NCT01701271|B1|Baseline|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
728742|NCT01701271|P1|Participant Flow|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
728743|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
728744|NCT01701271|O1|Outcome|Volunteers Evaluated|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
728745|NCT01701271|O1|Outcome|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
728746|NCT01701271|E1|Reported Event|Volunteers|20 volunteers both men and women with an age between 18 and 70 years suffering from Androgenetic Alopecia in several types apply on the scalp drops of the Hair Loss Prevention Lotion
728747|NCT01701245|B3|Baseline|Total|Total of all reporting groups
728748|NCT01701245|B2|Baseline|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
728749|NCT01701245|B1|Baseline|Standard of Care|No intervention, standard of care
728750|NCT01701245|P2|Participant Flow|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
728751|NCT01701245|P1|Participant Flow|Standard of Care|No intervention, standard of care
728752|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
728753|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
728754|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
728755|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
728756|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
728757|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
728758|NCT01701245|O2|Outcome|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
728759|NCT01701245|O1|Outcome|Standard of Care|No intervention, standard of care
728760|NCT01701245|E2|Reported Event|GammaCore|"Three stimulation treatments 2x/day 7 to 10 hours apart from one another. In addition, three stimulation treatments at the time of onset of symptoms of a headache attack.~GammaCore: vagal stimulation"
728763|NCT01701102|B4|Baseline|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728764|NCT01701102|B3|Baseline|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728765|NCT01701102|B2|Baseline|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728766|NCT01701102|B1|Baseline|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728767|NCT01701102|P4|Participant Flow|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)
728768|NCT01701102|P3|Participant Flow|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)
728769|NCT01701102|P2|Participant Flow|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)
728770|NCT01701102|P1|Participant Flow|Mepivacaine 37.5 mg|Mepivacaine (37.5 mg)
728771|NCT01701102|O4|Outcome|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728772|NCT01701102|O3|Outcome|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728773|NCT01701102|O2|Outcome|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728774|NCT01701102|O1|Outcome|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728775|NCT01701102|E4|Reported Event|Mepivacaine 24 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728776|NCT01701102|E3|Reported Event|Mepivacaine 27 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728777|NCT01701102|E2|Reported Event|Mepivacaine 30 mg Plus Fentanyl 10 µg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728778|NCT01701102|E1|Reported Event|Mepivacaine 37.5 mg|Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
728779|NCT01701063|B4|Baseline|Total|Total of all reporting groups
728832|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
728833|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
728834|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
728835|NCT01701024|O2|Outcome|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
728780|NCT01701063|B3|Baseline|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728781|NCT01701063|B2|Baseline|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728782|NCT01701063|B1|Baseline|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728783|NCT01701063|P3|Participant Flow|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728784|NCT01701063|P2|Participant Flow|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728785|NCT01701063|P1|Participant Flow|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 milligram per kilogram [mg/kg] of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with pegylated interferon alfa 2b (Peg-IFN-alfa-2b) 60 microgram per meter square (mcg/m^2) subcutaneous injection weekly and ribavirin (RBV) 200 mg capsules or 40 milligram per milliliter (mg/mL) solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved extended rapid virologic response (eRVR) or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable hepatitis C virus ribonucleic acid (HCV RNA) levels at Week 4 and Week 12.
728786|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728867|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728868|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
730554|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
728787|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728788|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728789|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728790|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728836|NCT01701024|O1|Outcome|ACYC|ACYC active, topically applied to the face for 12 weeks
728791|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728792|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728793|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728794|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728795|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728796|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728797|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728798|NCT01701063|O1|Outcome|Overall Participants|Participants aged 3 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 to 18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
730555|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
728799|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728800|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728801|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728802|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728803|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728804|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728805|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728806|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728807|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728808|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728809|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728810|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
730404|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
728811|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728812|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728813|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728814|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728815|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728816|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728817|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728818|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728819|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728820|NCT01701063|O3|Outcome|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728821|NCT01701063|O2|Outcome|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728822|NCT01701063|O1|Outcome|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
730405|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
728823|NCT01701063|E3|Reported Event|Cohort 3 (3-6 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 3 to 6 years received telaprevir twice daily for 12 weeks as a chewable tablet (18 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728824|NCT01701063|E2|Reported Event|Cohort 2 (7-12 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 7 to 12 years received telaprevir twice daily for 12 weeks as a chewable tablet (16 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200-mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728825|NCT01701063|E1|Reported Event|Cohort 1 (13-17 Years): Telaprevir + Peg-IFN-alfa-2b + RBV|Participants aged 13 to 17 years received telaprevir twice daily for 12 weeks either as a film coated tablet (15 mg/kg of body weight) or as a chewable tablet (14 mg/kg of body weight) in combination with Peg-IFN-alfa-2b 60 mcg/m^2 subcutaneous injection weekly and RBV 200 mg capsules or 40 mg/mL solution orally twice daily with a maximum dose of 1200 mg per day. Peg-IFN-alfa-2b and RBV were administered for 24 weeks in participants who achieved eRVR or for 48 weeks in participants who did not achieve eRVR. eRVR was defined as undetectable HCV RNA levels at Week 4 and Week 12.
728826|NCT01701024|B3|Baseline|Total|Total of all reporting groups
728827|NCT01701024|B2|Baseline|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
728828|NCT01701024|B1|Baseline|ACYC|ACYC active, topically applied to the face for 12 weeks
728829|NCT01701024|P2|Participant Flow|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
728830|NCT01701024|P1|Participant Flow|ACYC|ACYC active, topically applied to the face for 12 weeks
728839|NCT01701024|E2|Reported Event|ACYC Vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
728840|NCT01701024|E1|Reported Event|ACYC|ACYC active, topically applied to the face for 12 weeks
728841|NCT01701011|B4|Baseline|Total|Total of all reporting groups
728842|NCT01701011|B3|Baseline|Routine Care Control Group|"Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
728843|NCT01701011|B2|Baseline|Monitoring-control Group|"DRK and Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
728844|NCT01701011|B1|Baseline|PRCI-monitoring Group|"Coping intervention, Daily Record Keeping, Questionnaires~Coping intervention, Daily Record Keeping, Questionnaires :"
728845|NCT01701011|P3|Participant Flow|Routine Care Control Group|Patients receive only questionnaires
728846|NCT01701011|P2|Participant Flow|Monitoring-control Group|Daily Record Keeping and Questionnaires
728847|NCT01701011|P1|Participant Flow|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
728848|NCT01701011|O3|Outcome|Routine Care Control Group|Patients receive only questionnaires
728849|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
728850|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
728851|NCT01701011|O3|Outcome|Routine Care Control Group|patients receive questionnaires
728852|NCT01701011|O2|Outcome|Monitoring-control Group|Daily Record Keeping and Questionnaires
728853|NCT01701011|O1|Outcome|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
728854|NCT01701011|E3|Reported Event|Routine Care Control Group|patients received questionnaires
728855|NCT01701011|E2|Reported Event|Monitoring-control Group|Daily Record Keeping and Questionnaires
728856|NCT01701011|E1|Reported Event|PRCI-monitoring Group|Coping intervention, Daily Record Keeping, Questionnaires
728857|NCT01700907|B3|Baseline|Total|Total of all reporting groups
728858|NCT01700907|B2|Baseline|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
728859|NCT01700907|B1|Baseline|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728860|NCT01700907|P2|Participant Flow|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
728861|NCT01700907|P1|Participant Flow|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728862|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
728863|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728864|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
728865|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728866|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
728869|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728870|NCT01700907|O2|Outcome|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
728871|NCT01700907|O1|Outcome|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728872|NCT01700907|E2|Reported Event|Group SEVO|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
728873|NCT01700907|E1|Reported Event|Group DES|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
728874|NCT01699698|B3|Baseline|Total|Total of all reporting groups
728875|NCT01699698|B2|Baseline|Control|Normal cohort
728876|NCT01699698|B1|Baseline|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
728877|NCT01699698|P2|Participant Flow|Control|Normal cohort
728878|NCT01699698|P1|Participant Flow|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
728879|NCT01699698|O2|Outcome|Control|Normal cohort
728880|NCT01699698|O1|Outcome|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
728881|NCT01699698|O2|Outcome|Control|Normal cohort
728882|NCT01699698|O1|Outcome|Test Subject|UICC Stage II pancreatic ductal adenocarcinoma cohort
728883|NCT01699698|E2|Reported Event|Normal|Normal cohort
728884|NCT01699698|E1|Reported Event|Test Subject|UICC StageII pancreatic ductal adenocarcinoma cohort
728885|NCT01699685|B3|Baseline|Total|Total of all reporting groups
728886|NCT01699685|B2|Baseline|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728887|NCT01699685|B1|Baseline|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728888|NCT01699685|P2|Participant Flow|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728889|NCT01699685|P1|Participant Flow|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728890|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728891|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728892|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728893|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728894|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728895|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728896|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728897|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728898|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728899|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728900|NCT01699685|O2|Outcome|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728901|NCT01699685|O1|Outcome|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728902|NCT01699685|E2|Reported Event|Sequence B|QAB149 (150μg puff) + NVA237 (50μg puff) followed by QAB149 (150μg puff) + placebo
728903|NCT01699685|E1|Reported Event|Sequence A|QAB149 (150μg puff) + placebo followed by QAB149 (150μg puff) + NVA237 (50μg puff)
728904|NCT01699607|B3|Baseline|Total|Total of all reporting groups
728905|NCT01699607|B2|Baseline|Nonsmoker Subjects|Nonsmokers are subjects who smoked 40 cigarettes or less in their lifetime, and none within the past year.
728906|NCT01699607|B1|Baseline|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day in the past year.
728907|NCT01699607|P2|Participant Flow|Nonsmoking Subjects|Nonsmokers are subjects who have smoked less than 40 cigarettes in their lifetime, and none within the last year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
728908|NCT01699607|P1|Participant Flow|Cigarette Smokers|Cigarette smokers are subjects who smoke 10 or more cigarettes per day for the past year. All subjects will receive amphetamine at 0.5 kg/mg to induce elevated dopamine levels in the brain. This dosage of amphetamine is given by mouth about 150 minutes prior to the second PET scan.
728909|NCT01699607|O2|Outcome|Nonsmoking Subjects|Nonsmokers. These are subjects who smoked less than 40 cigarettes in their lifetime and none in the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan
728910|NCT01699607|O1|Outcome|Smoking Subjects|Cigarette smokers. These are subjects who smoke at least 10 cigarettes per day for the last year. All subjects will receive amphetamine to induce elevated dopamine levels in the brain at a dose of 0.5mg/kg. They will all receive the amphetamine prior to the second PET scan.
728911|NCT01699607|E1|Reported Event|Amphetamine|"There is only one arm to the study. All subjects will receive amphetamine.~Amphetamine: All subjects will receive amphetamine to induce elevated dopamine levels in the brain."
728912|NCT01700530|B4|Baseline|Total|Total of all reporting groups
728913|NCT01700530|B3|Baseline|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
728914|NCT01700530|B2|Baseline|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
728915|NCT01700530|B1|Baseline|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
728916|NCT01700530|P3|Participant Flow|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
728917|NCT01700530|P2|Participant Flow|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
728918|NCT01700530|P1|Participant Flow|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
728919|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
728920|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
728921|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
728922|NCT01700530|O3|Outcome|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
728923|NCT01700530|O2|Outcome|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
728924|NCT01700530|O1|Outcome|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
728925|NCT01700530|E3|Reported Event|Statins + Exercise|"Statins (40mg/day of simvastatin) plus exercise training (5 days/wk) for 12 weeks~Statins + Exercise: Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks"
728926|NCT01700530|E2|Reported Event|Exercise Only|"12 weeks of exercise training (5 days a week for 45-50 min a session)~Exercise only: 12 weeks of exercise training (5 days a week for 45-50 min a session)"
728927|NCT01700530|E1|Reported Event|Statin|"Statins (40mg/day)for an average of 12 weeks~Statin: Statins (40mg/day)for 12 weeks"
728928|NCT01700517|B4|Baseline|Total|Total of all reporting groups
728929|NCT01700517|B3|Baseline|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
728930|NCT01700517|B2|Baseline|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
728931|NCT01700517|B1|Baseline|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
728932|NCT01700517|P3|Participant Flow|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
728933|NCT01700517|P2|Participant Flow|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
728934|NCT01700517|P1|Participant Flow|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
728935|NCT01700517|O3|Outcome|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
728936|NCT01700517|O2|Outcome|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
728969|NCT01700335|E1|Reported Event|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728970|NCT01700192|B3|Baseline|Total|Total of all reporting groups
728971|NCT01700192|B2|Baseline|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728937|NCT01700517|O1|Outcome|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block~To assure the double blindness, pain measurement was realized by the assistant author using a 10 points pain analog visual scale (0, absence of pain, and 10 the worst imaginable pain). Patient and researcher did not know at which group patient belongs. This measurement was realized during immediate pre-op, and 6, 12, 24 and 48 hours after surgery. After this the average of pain for each group was analyzed."
728938|NCT01700517|E3|Reported Event|Sciatic Nerves Block|"In addition to the spinal anesthesia and femoral block, the anesthesia of the sciatic nerve at the top of the popliteal fossae was realized, also guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. 0.5% ropivacaine was injected associated to 75mcg clonidine.~sciatic nerves block : sciatic nerves block~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
728939|NCT01700517|E2|Reported Event|Control Group|"Spinal anesthesia with 0.5% isobaric bupivacaine, in isolation. Punctures in the femoral and popliteal areas were made to mask the femoral and sciatic block, respectively, with no infusion of any medication.~Spinal anesthesia : spinal anesthesia"
728940|NCT01700517|E1|Reported Event|Femoral Nerve Block|"In addition to the spinal anesthesia, block of the femoral nerve guided by ultrasonography (Nemio 17 - Toshiba Systems Co. - Japan) and neurosimulation (Stimuplex HNS 12 - Braun - Germany) with 1 Hz stimulus frequency, 1.2 to 0.5 mA energy. The technique used was femoral area puncture, at the level of the crural fold of skin, with a 0.5% (125mg) ropivacaine associated to 75 mcg of clonidine.~Spinal anesthesia : spinal anesthesia~Femoral nerve block : Femoral nerve block"
728941|NCT01700387|B3|Baseline|Total|Total of all reporting groups
728942|NCT01700387|B2|Baseline|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728989|NCT01700192|E2|Reported Event|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728990|NCT01700192|E1|Reported Event|MK-8237 12 DU|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
729034|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
728943|NCT01700387|B1|Baseline|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728944|NCT01700387|P2|Participant Flow|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs (every night at bedtime) Week 2: 1 tab bid (twice daily) Week 3: 1 tab q am (every day before noon) + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728945|NCT01700387|P1|Participant Flow|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs (every night at bedtime) Week 2: topiramate 25 mg bid (twice a day) Week 3: topiramate 25 mg q am (every day before noon) + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728946|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728947|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728948|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab q hs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs q hs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728972|NCT01700192|B1|Baseline|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
728949|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg q hs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50mg q hs Week 4: topiramate 50mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728950|NCT01700387|O2|Outcome|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728951|NCT01700387|O1|Outcome|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728952|NCT01700387|E2|Reported Event|OnabotulinumtoxinA + Placebo|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with placebo. During the first month of the treatment period, subjects will titrate as follows:~Week 1: 1 tab qhs Week 2: 1 tab bid Week 3: 1 tab q am + 2 tabs qhs Week 4: 2 tabs bid~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
729242|NCT01698554|B5|Baseline|Total|Total of all reporting groups
728953|NCT01700387|E1|Reported Event|OnabotulinumtoxinA + Topiramate|"Subject will receive 155 U onabotulinumtoxinA injections at 31 sites every 3 months for 12 months and treat daily with topiramate. During the first month of the treatment period, subjects will titrate as follows:~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period.~onabotulinumtoxinA: All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5."
728954|NCT01700348|B1|Baseline|All Randomized Subjects|The study was terminated early, data were not analyzed and the plaque samples were destroyed. Data cannot be provided for each arm separately, but only in aggregate.
728955|NCT01700348|P1|Participant Flow|All Enrolled Subjects|Airflosser & Manual Floss
728956|NCT01700348|O1|Outcome|All Randomized Subjects|"The study was terminated early, data were not analyzed and the plaque samples were destroyed."
728957|NCT01700348|E1|Reported Event|All Randomized Subjects|Summary of AEs for All Randomized Subjects
728958|NCT01700335|B1|Baseline|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
728959|NCT01700335|P2|Participant Flow|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728960|NCT01700335|P1|Participant Flow|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728961|NCT01700335|O1|Outcome|All Participants|All participants who received at least 1 dose of SyB L-1101 either at 1200 mg/day or 1800 mg/day intravenously.
728962|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728963|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728964|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728965|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728966|NCT01700335|O2|Outcome|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728967|NCT01700335|O1|Outcome|SyB L-1101 1200 mg/Day Group|"Cohort 1: Participants were administered 1200 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728968|NCT01700335|E2|Reported Event|SyB L-1101 1800 mg/Day Group|"Cohort 2: Participants were administered 1800 mg/day of SyB L-1101 intravenously for 3 consecutive days, followed by 11-day observation period.~The treatment period of 14 days constitutes 1 cycle, and the treatment was allowed for up to 8 cycles."
728973|NCT01700192|P2|Participant Flow|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728974|NCT01700192|P1|Participant Flow|MK-8237|Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.
728975|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728976|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
728977|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728978|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
728979|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728980|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
728981|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728982|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
728983|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728984|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
728985|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728986|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
728987|NCT01700192|O2|Outcome|Placebo|Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
728988|NCT01700192|O1|Outcome|MK-8237|Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
729281|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
728991|NCT01700179|B1|Baseline|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
728992|NCT01700179|P1|Participant Flow|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per the label) for Days 1-84.~ACH-0143102~Ribavirin"
728993|NCT01700179|O1|Outcome|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
728994|NCT01700179|E1|Reported Event|ACH-0143102 Plus Ribavirin|"ACH-0143102 225 mg loading dose on Day 1 followed by 75 mg maintenance dose on Days 2-84. Weight-based RBV (as per label) for Days 1-84.~ACH-0143102~Ribavirin"
728995|NCT01700140|B4|Baseline|Total|Total of all reporting groups
728996|NCT01700140|B3|Baseline|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
728997|NCT01700140|B2|Baseline|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
728998|NCT01700140|B1|Baseline|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
728999|NCT01700140|P3|Participant Flow|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729000|NCT01700140|P2|Participant Flow|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729001|NCT01700140|P1|Participant Flow|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729002|NCT01700140|O3|Outcome|SyB D-0701 25 cm2 Patch|SyB D-0701 25 cm2 patch (18.75 mg) was applied to subjects in low dose group and high dose group.
729003|NCT01700140|O2|Outcome|SyB D-0701 15 cm2 Patch|SyB D-0701 15 cm2 patch (11.25 mg) was applied to subjects in high dose group.
729004|NCT01700140|O1|Outcome|Placebo Patch|"Placebo 15 cm2 patch was applied to subjects in placebo group and low dose group.~Placebo 25 cm2 patch was applied to subjects in placebo group."
729005|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729155|NCT01699087|B1|Baseline|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729006|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729007|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729008|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729009|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729010|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729011|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729012|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729013|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729014|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729015|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729016|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729017|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729018|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729019|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729020|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729021|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729022|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729023|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729024|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729156|NCT01699087|P1|Participant Flow|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729025|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729026|NCT01700140|O3|Outcome|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729027|NCT01700140|O2|Outcome|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729028|NCT01700140|O1|Outcome|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729029|NCT01700140|E3|Reported Event|SyB D-0701: High Dose Group|Study drug patches [High dose group (30.00 mg): SyB D-0701 15 cm2 patch (11.25 mg) + SyB D-0701 25 cm2 patch (18.75 mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729030|NCT01700140|E2|Reported Event|SyB D-0701: Low Dose Group|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch (18.75mg)] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729031|NCT01700140|E1|Reported Event|Placebo Group|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
729032|NCT01699867|B1|Baseline|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
729033|NCT01699867|P1|Participant Flow|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
729035|NCT01699867|O1|Outcome|Optical Coherence Tomography (Single-arm)|Specimens from all patients were evaluated by optical coherence tomography.
729036|NCT01699867|E1|Reported Event|All Patients (Single-arm)|All enrolled study patients.
729037|NCT01699815|B3|Baseline|Total|Total of all reporting groups
729038|NCT01699815|B2|Baseline|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
729039|NCT01699815|B1|Baseline|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
729040|NCT01699815|P2|Participant Flow|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
729041|NCT01699815|P1|Participant Flow|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
729042|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
729043|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
729044|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
729045|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
729046|NCT01699815|O2|Outcome|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
729047|NCT01699815|O1|Outcome|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended by manufacturer package insert.~Acetaminophen"
729048|NCT01699815|E2|Reported Event|Closure Group|"The closure group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered upon onset of skin closure.~Acetaminophen"
729049|NCT01699815|E1|Reported Event|Preemptive Group|"The preemptive group will receive one dose of 1 gram of IV acetaminophen every 6 hours x 24 hours with the first dose administered within 60 minutes prior to incision. Each infusion will be administered over 15 minutes as recommended for OfirmevTM administration.~Acetaminophen"
729050|NCT01699789|B3|Baseline|Total|Total of all reporting groups
729157|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729158|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729051|NCT01699789|B2|Baseline|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729052|NCT01699789|B1|Baseline|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729053|NCT01699789|P2|Participant Flow|Community Engagement and Planning CEP|"The CEP arm supported 4 months of planning for the CEP Council consisting of representatives from all assigned programs in biweekly 2 hour meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites were provided with enrolled client lists.~QI Program: The QI program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~CEP Council: The CEP Council was supported by a workbook de"
729243|NCT01698554|B4|Baseline|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729054|NCT01699789|P1|Participant Flow|Resources for Services RS|"The RS condition offers time-limited technical assistance to individual agencies, coupled with outreach from a community engagement specialty, to participate in structured reviews of components of the Quality Improvement (QI) Program Intervention as implemented by the RS Expert Team.~QI Program: The quality improvement program is an evidence-based toolkit from prior studies that supported team leadership, case and care management, medication management, and CBT for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.~RS Expert Team: The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. T"
729055|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729056|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729057|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729159|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729160|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
730500|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
729058|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729059|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729060|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729061|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729062|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729063|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729064|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729161|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729162|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
730556|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
729065|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729066|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729067|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729068|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729069|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729070|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729071|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729163|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729164|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
730821|NCT01690000|P2|Participant Flow|Placebo|Identical placebo given nightly for 12 months
729072|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729073|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729074|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729075|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729076|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729077|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729078|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729165|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729166|NCT01699087|O1|Outcome|PRK ALLEGRETTO|Photorefractive keratectomy (PRK) surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
730557|NCT01691313|E4|Reported Event|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
729079|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729080|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729081|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729082|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729083|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729084|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729085|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729167|NCT01699087|E2|Reported Event|PRK ALLEGRETTO|All subjects who underwent PRK surgery using the ALLEGRETTO WAVE EYE-Q excimer laser system for myopic wavefront-optimized ablation
729168|NCT01699087|E1|Reported Event|Pre-treatment|All subjects who consented to participate in the study prior to the initiation of study treatment
730558|NCT01691313|E3|Reported Event|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
729086|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729087|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729088|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729089|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729090|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729091|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729092|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729169|NCT01699022|B1|Baseline|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
732339|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
729093|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729094|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729095|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729096|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729097|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729098|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729099|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729170|NCT01699022|P1|Participant Flow|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
729171|NCT01699022|O1|Outcome|Cyclofem|
729100|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729101|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729102|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729103|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729104|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729105|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729106|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729172|NCT01699022|O1|Outcome|Cyclofem|
729173|NCT01699022|O1|Outcome|Cyclofem|
729174|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
729107|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729108|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729109|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729110|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729111|NCT01699789|O2|Outcome|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729112|NCT01699789|O1|Outcome|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729113|NCT01699789|E2|Reported Event|Community Engagement and Planning CEP|CEP supports 4 months of planning for the CEP Council of representatives from assigned programs in biweekly 2-hr meetings to fit trainings in the QI Program to the community and develop strategies across programs to collaborate as a network. The CEP Council developed a written plan for training and monitoring and supported implementation of the training plan. CEP sites received enrolled client lists. The toolkit is the same as RS. The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
729175|NCT01699022|O1|Outcome|Cyclofem|
729176|NCT01699022|O1|Outcome|Cyclofem|
729177|NCT01699022|O1|Outcome|Cyclofem|
729178|NCT01699022|O1|Outcome|Cyclofem|
729179|NCT01699022|O1|Outcome|Cyclofem|
729533|NCT01697345|O1|Outcome|Continued Vaginal Testosterone Therapy|Participants who chose to continue vaginal testosterone therapy upon completion of the study.
729114|NCT01699789|E1|Reported Event|Resources for Services RS|"RS offers time-limited technical assistance to individual agencies and outreach from a community engagement specialty, to review components of the QI Program Intervention as implemented by the RS Expert Team.~QI Program: The QI program is an evidence-based toolkit that supported team leadership, case and care management, medication management, and CBT for depression. The Case management manual supported depression screening and tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual. The expert team for RS consisted of 3 psychiatrists, a psychologist expert in CBT, a nurse care manager, a community engagement specialist, a QI expert, and staff support. The team offered 12 webinars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management."
729115|NCT01699763|B1|Baseline|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
729116|NCT01699763|P1|Participant Flow|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
729117|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
729118|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
729119|NCT01699763|O1|Outcome|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
729120|NCT01699763|E1|Reported Event|Subjects With and Without Diabetes|All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
729121|NCT01699750|B3|Baseline|Total|Total of all reporting groups
729122|NCT01699750|B2|Baseline|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
729123|NCT01699750|B1|Baseline|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
729124|NCT01699750|P2|Participant Flow|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
729125|NCT01699750|P1|Participant Flow|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
729126|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
729127|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
729128|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
729129|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
729130|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
729131|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
729132|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
729133|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
729134|NCT01699750|O4|Outcome|BIOTRUE With Acuvue Oasys|BIOTRUE with senofilcon A contact lenses for 30 days
729135|NCT01699750|O3|Outcome|BIOTRUE With Air Optix Aqua|BIOTRUE with lotrafilcon B contact lenses for 30 days
729136|NCT01699750|O2|Outcome|OFPM With Acuvue Oasys|OFPM with senofilcon A contact lenses for 30 days
729137|NCT01699750|O1|Outcome|OFPM With Air Optix Aqua|OFPM with lotrafilcon B contact lenses for 30 days
729138|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
729139|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
729140|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
729141|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
729142|NCT01699750|O2|Outcome|Acuvue Oasys|Senofilcon A contact lenses with OFPM and BIOTRUE for 30 days each
729143|NCT01699750|O1|Outcome|Air Optix Aqua|Lotrafilcon B contact lenses with OFPM and BIOTRUE for 30 days each
729144|NCT01699750|E2|Reported Event|ACUVUE OASYS With HYDRACLEAR|Senofilcon A contact lenses worn for 60 days, replaced biweekly
729145|NCT01699750|E1|Reported Event|AIR OPTIX AQUA|Lotrafilcon B contact lenses worn for 60 days, replaced monthly
729146|NCT01699373|B3|Baseline|Total|Total of all reporting groups
729147|NCT01699373|B2|Baseline|Manual Palpation|
729148|NCT01699373|B1|Baseline|Ultrasound-assisted|Pre-procedural ultrasound scan performed
729149|NCT01699373|P2|Participant Flow|Manual Palpation|
729150|NCT01699373|P1|Participant Flow|Ultrasound-assisted|Pre-procedural ultrasound scan performed
729151|NCT01699373|O2|Outcome|Manual Palpation|
729152|NCT01699373|O1|Outcome|Ultrasound-assisted|Pre-procedural ultrasound scan performed
729153|NCT01699373|E2|Reported Event|Manual Palpation|
729154|NCT01699373|E1|Reported Event|Ultrasound-assisted|Pre-procedural ultrasound scan performed
729180|NCT01699022|O1|Outcome|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
729181|NCT01699022|E1|Reported Event|Injection Cyclofem|"Injection of Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
729182|NCT01698814|B3|Baseline|Total|Total of all reporting groups
729183|NCT01698814|B2|Baseline|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
729184|NCT01698814|B1|Baseline|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
729185|NCT01698814|P2|Participant Flow|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
729186|NCT01698814|P1|Participant Flow|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
729187|NCT01698814|O2|Outcome|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
729188|NCT01698814|O1|Outcome|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
729189|NCT01698814|E2|Reported Event|AL-4943A Vehicle|AL-4943A Ophthalmic Solution Vehicle, one drop instilled in both eyes once daily for up to 6 weeks
729190|NCT01698814|E1|Reported Event|AL-4943A|AL-4943A Ophthalmic Solution, one drop instilled in both eyes once daily for up to 6 weeks
729191|NCT01698801|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
729192|NCT01698801|P1|Participant Flow|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
729282|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
729193|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
729194|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
729195|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
729196|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
729197|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or lenalidomide discontinuation for any reason."
729198|NCT01698801|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason.~Dexamethasone 40 mg orally once daily on Days 1, 8, 15 and 22 in each 28-day cycle until progressive disease or Lenalidomide discontinuation for any reason."
729199|NCT01698801|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide: 25 mg oral lenalidomide once daily on Days 1 through 21 of each 28-day cycle~Dexamethasone: 40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle"
729200|NCT01698775|B3|Baseline|Total|Total of all reporting groups
729201|NCT01698775|B2|Baseline|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
729202|NCT01698775|B1|Baseline|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
729203|NCT01698775|P2|Participant Flow|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
729204|NCT01698775|P1|Participant Flow|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
729205|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
729206|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
729207|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
729208|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
729209|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
729210|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
729211|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
729244|NCT01698554|B3|Baseline|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729283|NCT01698502|O1|Outcome|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
729212|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
729213|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
729214|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
729215|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
729216|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
729217|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
729218|NCT01698775|O1|Outcome|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
729219|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
729220|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
729221|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
729222|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
729223|NCT01698775|O2|Outcome|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
729224|NCT01698775|O1|Outcome|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
729225|NCT01698775|E4|Reported Event|Placebo to Omarigliptin (Phase A) → Glipizide (Phase B)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks. Phase B: matching placebo to omarigliptin orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received glipizide 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
729264|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729265|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729226|NCT01698775|E3|Reported Event|Omarigliptin (Phase A) → Omarigliptin (Phase B)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks. Phase B: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 30 weeks. Participants who were not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study (Week 1 through Week 24) received matching placebo to glipizide daily in a blinded manner during Phase B of the study (Week 24 through Week 54).
729227|NCT01698775|E2|Reported Event|Placebo to Omarigliptin (Phase A)|Phase A: matching placebo to omarigliptin orally once a week for 24 weeks.
729228|NCT01698775|E1|Reported Event|Omarigliptin (Phase A)|Phase A: omarigliptin 12.5 mg or 25 mg capsule orally once a week for 24 weeks.
729229|NCT01698684|B4|Baseline|Total|Total of all reporting groups
729230|NCT01698684|B3|Baseline|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
729231|NCT01698684|B2|Baseline|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
729232|NCT01698684|B1|Baseline|Placebo|Placebo: One dose 15 minutes before attempting intercourse
729233|NCT01698684|P3|Participant Flow|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
729234|NCT01698684|P2|Participant Flow|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
729235|NCT01698684|P1|Participant Flow|Placebo|Placebo: One dose 15 minutes before attempting intercourse
729236|NCT01698684|O3|Outcome|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
729237|NCT01698684|O2|Outcome|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
729238|NCT01698684|O1|Outcome|Placebo|Placebo: One dose 15 minutes before attempting intercourse
729239|NCT01698684|E3|Reported Event|Avanafil 200 mg|Avanafil 200 mg: One dose 15 minutes before attempting intercourse
729240|NCT01698684|E2|Reported Event|Avanafil 100 mg|Avanafil 100 mg: One dose 15 minutes before attempting intercourse
729241|NCT01698684|E1|Reported Event|Placebo|Placebo: One dose 15 minutes before attempting intercourse
729245|NCT01698554|B2|Baseline|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729246|NCT01698554|B1|Baseline|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729247|NCT01698554|P4|Participant Flow|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729248|NCT01698554|P3|Participant Flow|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729249|NCT01698554|P2|Participant Flow|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729250|NCT01698554|P1|Participant Flow|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729251|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729252|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729253|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729254|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729255|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729256|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729257|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729258|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729259|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729260|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729261|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729262|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729263|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729266|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729267|NCT01698554|O4|Outcome|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729268|NCT01698554|O3|Outcome|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729269|NCT01698554|O2|Outcome|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729270|NCT01698554|O1|Outcome|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729271|NCT01698554|E4|Reported Event|Vehicle of Bimatoprost Solution 0.03 %|Vehicle of bimatoprost solution 0.03 % multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729272|NCT01698554|E3|Reported Event|Vehicle of Bimatoprost Formulation A Solution|Vehicle of bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729273|NCT01698554|E2|Reported Event|Bimatoprost Solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) multi-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729274|NCT01698554|E1|Reported Event|Bimatoprost Formulation A Solution|Bimatoprost formulation A solution single-dose vial applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
729275|NCT01698502|B3|Baseline|Total|Total of all reporting groups
729276|NCT01698502|B2|Baseline|Untrained|Healthy, sedentary (Maximal oxygen uptake (VO2max), ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
729277|NCT01698502|B1|Baseline|Trained|Healthy, Endurance trained (Maximal oxygen uptake (VO2max), ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
729278|NCT01698502|P2|Participant Flow|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
729279|NCT01698502|P1|Participant Flow|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
729280|NCT01698502|O2|Outcome|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
729479|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
729284|NCT01698502|E2|Reported Event|Untrained|Healthy, sedentary (VO2max, ml*min-1*kg-1<50), 20-30 year, BMI: 18,5-25kg/m2, males.
729285|NCT01698502|E1|Reported Event|Trained|Healthy, Endurance trained (VO2max, ml*min-1*kg-1>60), 20-30 year, BMI: 18,5-25kg/m2, males.
729286|NCT01698320|B3|Baseline|Total|Total of all reporting groups
729287|NCT01698320|B2|Baseline|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729288|NCT01698320|B1|Baseline|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729289|NCT01698320|P3|Participant Flow|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729290|NCT01698320|P2|Participant Flow|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729291|NCT01698320|P1|Participant Flow|All Enrolled Subjects|Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.
729292|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729293|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729294|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729295|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729296|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729297|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729298|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729299|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729480|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
729300|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729301|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729302|NCT01698320|O2|Outcome|Albuterol MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729303|NCT01698320|O1|Outcome|Placebo MDPI-Albuterol MDPI|"During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.~The double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise."
729304|NCT01698320|E4|Reported Event|Albuterol MDPI (Formerly Albuterol) - Open Label Period|After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
729305|NCT01698320|E3|Reported Event|Albuterol MDPI (Formerly Placebo) - Open Label Period|After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).
729306|NCT01698320|E2|Reported Event|Placebo MDPI - Double-blind Period|Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.
729307|NCT01698320|E1|Reported Event|Albuterol MDPI - Double-blind Period|Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.
729308|NCT01697969|B1|Baseline|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
729309|NCT01697969|P1|Participant Flow|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
729310|NCT01697969|O2|Outcome|Right Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
729311|NCT01697969|O1|Outcome|Left Eye|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily for 14 days
729312|NCT01697969|E1|Reported Event|Overall Study|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop once daily in both eyes for 14 days
729314|NCT01697956|B2|Baseline|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729315|NCT01697956|B1|Baseline|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729316|NCT01697956|P2|Participant Flow|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729317|NCT01697956|P1|Participant Flow|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729318|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729319|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729320|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729321|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729322|NCT01697956|O4|Outcome|Placebo Nasal Aerosol - Shift to Low|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729323|NCT01697956|O3|Outcome|Placebo Nasal Aerosol - Shift to High|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729324|NCT01697956|O2|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to Low|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729325|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day - Shift to High|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729326|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729327|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729328|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
729329|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
729330|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
729331|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
729332|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
729333|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
729334|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
729335|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
729336|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
729337|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
729338|NCT01697956|O2|Outcome|BDP Pharmacokinetic Parameters|PK values characterizing beclomethasone dipropionate (BDP)
729339|NCT01697956|O1|Outcome|17-BMP Pharmacokinetic Parameters|PK values characterizing the active metabolite for BDP
729340|NCT01697956|O2|Outcome|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729341|NCT01697956|O1|Outcome|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729342|NCT01697956|E2|Reported Event|Placebo Nasal Aerosol|Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 42 day (6 week) Treatment Period.
729343|NCT01697956|E1|Reported Event|BDP Nasal Aerosol 80 mcg/Day|BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 42 day (6 week) Treatment Period.
729344|NCT01697696|B3|Baseline|Total|Total of all reporting groups
729345|NCT01697696|B2|Baseline|QAB149|75 μg once-daily
729346|NCT01697696|B1|Baseline|NVA237|12.5 μg twice-daily
729347|NCT01697696|P2|Participant Flow|QAB149|75 μg once-daily
729348|NCT01697696|P1|Participant Flow|NVA237|12.5 μg twice-daily
729349|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729350|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
729351|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729352|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
729353|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729354|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
729355|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729356|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
729357|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729358|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
729359|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729360|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
729361|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729362|NCT01697696|O1|Outcome|NVA237|12.5 μg twice-daily
729363|NCT01697696|O2|Outcome|QAB149|75 μg once-daily
729370|NCT01697592|B10|Baseline|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729371|NCT01697592|B9|Baseline|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZD (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729372|NCT01697592|B8|Baseline|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG throughout the duration of the study.
729373|NCT01697592|B7|Baseline|Placebo/Gln (Phase A) Switching to Omari. 25 mg/Gln (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729374|NCT01697592|B6|Baseline|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
729375|NCT01697592|B5|Baseline|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729376|NCT01697592|B4|Baseline|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
729377|NCT01697592|B3|Baseline|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
729378|NCT01697592|B2|Baseline|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
729379|NCT01697592|B1|Baseline|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
729481|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
729482|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
729380|NCT01697592|P10|Participant Flow|Placebo/α-GI (Phase A) Switching to Omari. 25 mg/α-GI (Ph. B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729381|NCT01697592|P9|Participant Flow|Placebo/TZD (Phase A) Switching to Omari. 25 mg/TZ (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729382|NCT01697592|P8|Participant Flow|Placebo/BG (Phase A) Switching to Omari. 25 mg/BG (Phase B)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of BG. throughout the duration of the study.
729383|NCT01697592|P7|Participant Flow|Placebo/Gln. (Phase A) Switching to Omari. 25 mg/Gln (Phase B)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729384|NCT01697592|P6|Participant Flow|Placebo/SU (Phase A) Switching to Omari. 25 mg/SU (Phase B)|Placebo to omarigliptin (omari.)administered orally once weekly for 24 weeks during Phase A. Omarigliptin 25 mg administered orally once weekly for 28 weeks during Phase B. Participants continued pre-study basal medication of SU throughout the duration of the study.
729385|NCT01697592|P5|Participant Flow|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-glucosidase (α-GI) throughout the duration of the study.
729386|NCT01697592|P4|Participant Flow|Omarigliptin 25 mg/Thiazolidinediones (TZD) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
729387|NCT01697592|P3|Participant Flow|Omarigliptin 25 mg/Biguanides (BG) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
729388|NCT01697592|P2|Participant Flow|Omarigliptin 25 mg/Glinides (Gln) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
729389|NCT01697592|P1|Participant Flow|Omarigliptin 25 mg/Sulfonylureas (SU) (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
729390|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729391|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729392|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
729640|NCT01696773|O1|Outcome|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
729393|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln. throughout the duration of the study.
729394|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
729395|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729396|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729397|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
729398|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729399|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
729400|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729401|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729402|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG. throughout the duration of the study.
729403|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued pre-study basal medication of Gln throughout the duration of the study."
729404|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued prestudy basal medication of SU throughout the duration of the study."
729483|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
729405|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729406|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
729407|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
729408|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729409|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
729410|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729411|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729412|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
729413|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729414|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
729415|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729416|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729417|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
729418|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729419|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
729420|NCT01697592|O10|Outcome|Omarigliptin 25mg/α-GI (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729421|NCT01697592|O9|Outcome|Omarigliptin 25mg/TZD (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729422|NCT01697592|O8|Outcome|Omarigliptin 25mg/BG (Phase B)|Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo. Participants continued pre-study basal medication of BG throughout the duration of the study.
729423|NCT01697592|O7|Outcome|Omarigliptin 25mg/Gln (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued pre-study basal medication of Gln throughout the duration of the study."
729424|NCT01697592|O6|Outcome|Omarigliptin 25mg/SU (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued prestudy basal medication of SU throughout the duration of the study."
729425|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729426|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
729427|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
729428|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
729429|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
729430|NCT01697592|O10|Outcome|Placebo/α-GI (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729431|NCT01697592|O9|Outcome|Placebo/TZD (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729432|NCT01697592|O8|Outcome|Placebo/BG (Phase A)|Placebo to Omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
729484|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
729433|NCT01697592|O7|Outcome|Placebo/Gln. (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729434|NCT01697592|O6|Outcome|Placebo/SU (Phase A)|Placebo to omarigliptin administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
729435|NCT01697592|O5|Outcome|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729436|NCT01697592|O4|Outcome|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729437|NCT01697592|O3|Outcome|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
729438|NCT01697592|O2|Outcome|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729439|NCT01697592|O1|Outcome|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
729440|NCT01697592|E12|Reported Event|Omarigliptin 25mg/ABM (Phase B)|"Omarigliptin 25mg administered orally once weekly for 28 weeks during Phase B after switching from placebo.~Participants continued any prestudy basal medications throughout the duration of the study."
729441|NCT01697592|E11|Reported Event|Omarigliptin 25 mg/α-GI (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729442|NCT01697592|E10|Reported Event|Omarigliptin 25 mg/TZD (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of TZD throughout the duration of the study.
729443|NCT01697592|E9|Reported Event|Omarigliptin 25 mg/BG (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of BG throughout the duration of the study.
729444|NCT01697592|E8|Reported Event|Omarigliptin 25 mg/Gln (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of Gln throughout the duration of the study.
729445|NCT01697592|E7|Reported Event|Omarigliptin 25 mg/SU (Phase A+B)|Omarigliptin 25 mg administered orally once weekly for 52 weeks (24 weeks during Phase A and 28 weeks during Phase B). Participants continued pre-study basal medication of SU throughout the duration of the study.
729446|NCT01697592|E6|Reported Event|Placebo/ABM (Phase A)|Placebo to omargliptin administered orally once weekly for 24 weeks during Phase A. Participants continued any pre-study basal medication (ABM)throughout the duration of the study.
729447|NCT01697592|E5|Reported Event|Omarigliptin 25 mg/α-GI (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of α-GI throughout the duration of the study.
729448|NCT01697592|E4|Reported Event|Omarigliptin 25 mg/TZD (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of TZD throughout the duration of the study.
729449|NCT01697592|E3|Reported Event|Omarigliptin 25 mg/BG (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of BG throughout the duration of the study.
729450|NCT01697592|E2|Reported Event|Omarigliptin 25 mg/Gln (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of Gln throughout the duration of the study.
729451|NCT01697592|E1|Reported Event|Omarigliptin 25 mg/SU (Phase A)|Omarigliptin 25 mg administered orally once weekly for 24 weeks during Phase A. Participants continued pre-study basal medication of SU throughout the duration of the study.
729452|NCT01697501|B1|Baseline|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
729453|NCT01697501|P1|Participant Flow|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
729454|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
729455|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
729456|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
729457|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
729458|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
729459|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
729460|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
729461|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
729462|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
729463|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
729464|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
729465|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
729466|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
729467|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
729468|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
729469|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs12979860
729470|NCT01697501|O4|Outcome|"TC+TT"|at IL28B genotype rs12979860
729471|NCT01697501|O3|Outcome|"TT"|at IL28B genotype rs12979860
729472|NCT01697501|O2|Outcome|"TC"|at IL28B genotype rs12979860
729473|NCT01697501|O1|Outcome|"CC"|at IL28B genotype rs12979860
729474|NCT01697501|O5|Outcome|"Overall"|at IL28B genotype rs8099917
729475|NCT01697501|O4|Outcome|"GT+GG"|at IL28B genotype rs8099917
729476|NCT01697501|O3|Outcome|"GG"|at IL28B genotype rs8099917
729477|NCT01697501|O2|Outcome|"GT"|at IL28B genotype rs8099917
729478|NCT01697501|O1|Outcome|"TT"|at IL28B genotype rs8099917
729494|NCT01697501|E1|Reported Event|Chronic Hepatitis B Patients|Interleukin 28B testing: Blood sampling for IL28B genotyping
729495|NCT01697462|B1|Baseline|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
729496|NCT01697462|P1|Participant Flow|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of metastatic colorectal cancer (mCRC) were followed until progression of the disease (PD), unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
729497|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
729498|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
729499|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
729500|NCT01697462|O1|Outcome|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
729501|NCT01697462|E1|Reported Event|mCRC Participants|Participants who were receiving capecitabine (Xeloda) as per local label for the treatment of mCRC were followed until PD, unacceptable toxicity, lost to follow up, death from any cause, or withdrawal of informed consent.
729502|NCT01697449|B1|Baseline|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
729503|NCT01697449|P1|Participant Flow|Colorectal Cancer (CRC) Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
729504|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
729505|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
729506|NCT01697449|O1|Outcome|Unresectable|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
729507|NCT01697449|O2|Outcome|Unresectable CRC at Baseline|Participants with unresectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
729508|NCT01697449|O1|Outcome|Resectable/Potentially Resectable CRC at Baseline|Participants with resectable metastatic CRC at baseline received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent..
729509|NCT01697449|O1|Outcome|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
729510|NCT01697449|E1|Reported Event|CRC Cohort|Participants with metastatic CRC (resectable/unresectable at baseline) received bevacizumab in combination with chemotherapy according to registered indication in routine clinical practice until progression of disease, unacceptable toxicity, lost to follow up, death, or withdrawal of informed consent.
729511|NCT01697358|B3|Baseline|Total|Total of all reporting groups
729512|NCT01697358|B2|Baseline|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729513|NCT01697358|B1|Baseline|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729525|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729576|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729577|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
729514|NCT01697358|P2|Participant Flow|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729515|NCT01697358|P1|Participant Flow|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729516|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729517|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729518|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729519|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729559|NCT01696994|P2|Participant Flow|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729520|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729521|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729522|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729523|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729524|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729526|NCT01697358|O2|Outcome|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729527|NCT01697358|O1|Outcome|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729528|NCT01697358|E2|Reported Event|OMM Alone|Optimal Medical Management (OMM) alone: Pain treatment was evaluated, and medical management of subjects’ pain was optimized. The investigator and subject determined an individual OMM treatment plan, which should include non-investigational pharmacologic agents (e.g., tricyclic antidepressants, opioid analgesics or tramadol, antiepileptics, or lidocaine) and/or interventional therapies (e.g., therapeutic injections, radiofrequency, acupuncture, and physical therapy) as appropriate. Excluded from OMM is intrathecal drug delivery (IDD), peripheral nerve stimulation (PNS; not an approved indication in the USA), back surgery at the location related to the subject’s original back pain complaint and experimental therapies. Data regarding pain treatments implemented during the study were collected to reveal how medical management was optimized.
729529|NCT01697358|E1|Reported Event|SCS + OMM|Spinal Cord Stimulation (SCS) using multicolumn surgical lead + Optimal Medical Management (OMM): In addition to the OMM described under the OMM group, subjects underwent an SCS screening test and, if successful, received an INS implant. Any SCS group subject not implanted continued to be treated with OMM and were followed as part of the SCS group.
729530|NCT01697345|B1|Baseline|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
729531|NCT01697345|P1|Participant Flow|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
729532|NCT01697345|O2|Outcome|Did Not Continue Vaginal Testosterone Therapy|Participants who chose not to continue vaginal testosterone upon completion of the study.
729560|NCT01696994|P1|Participant Flow|Control|Participants receive standard medical care.
729534|NCT01697345|O2|Outcome|FSFI Pain Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
729535|NCT01697345|O1|Outcome|FSFI Pain Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
729536|NCT01697345|O2|Outcome|FSFI Satisfaction Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
729537|NCT01697345|O1|Outcome|FSFI Satisfaction Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
729538|NCT01697345|O2|Outcome|FSFI Orgasm Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
729539|NCT01697345|O1|Outcome|FSFI Orgasm Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
729540|NCT01697345|O2|Outcome|FSFI Lubrication Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
729541|NCT01697345|O1|Outcome|FSFI Lubrication Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
729542|NCT01697345|O2|Outcome|FSFI Arousal Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
729543|NCT01697345|O1|Outcome|FSFI Arousal Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
729544|NCT01697345|O2|Outcome|FSFI Desire Domain Score (Posttest)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
729545|NCT01697345|O1|Outcome|FSFI Desire Domain Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
729546|NCT01697345|O2|Outcome|FSFI Total Score (Postteset)|Testosterone USP micronized powder supplied by Medisca Pharmacy was compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream was supplied in pre-filled syringes and each 0.5 mL dose delivered 300 mcg of testosterone daily. The cream was applied to the vaginal opening once daily for four weeks (28 days).
729547|NCT01697345|O1|Outcome|FSFI Total Score (Pretest)|Administered to participants prior to starting vaginal testosterone therapy.
729548|NCT01697345|E1|Reported Event|Vaginal Testosterone|Testosterone USP micronized powder supplied by Medisca Pharmacy will be compounded by Precision Compounding pharmacy as testosterone 0.3% per 0.5 milliliters (mL) in pharmabase cream. The compounded testosterone vaginal cream will be supplied in pre-filled syringes and each 0.5 mL dose will deliver 300 mcg of testosterone daily. The cream will be applied to the vaginal opening once daily for four weeks (28 days).
729549|NCT01697319|B1|Baseline|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
729550|NCT01697319|P1|Participant Flow|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
729551|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
729552|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
729553|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
729554|NCT01697319|O1|Outcome|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
729555|NCT01697319|E1|Reported Event|BMN 110 at 2.0 mg/kg/Week|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for an initial treatment phase of 48 weeks and an extension treatment phase of up to an additional 96 weeks.
729556|NCT01696994|B3|Baseline|Total|Total of all reporting groups
729557|NCT01696994|B2|Baseline|Ovarian Screening|Participants undergo blood sample collection for Cancer Antigen 125 (CA-125) analysis at baseline and annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729558|NCT01696994|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire (BQ) at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729641|NCT01696773|E2|Reported Event|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
729561|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729562|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729563|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729564|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
729565|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729566|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729567|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729568|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729569|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729570|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729571|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729572|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729573|NCT01696994|O1|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729574|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729575|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
729578|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729579|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
729580|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729581|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
729582|NCT01696994|O2|Outcome|Ovarian Screening|Participants undergo blood sample collection for CA-125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729583|NCT01696994|O1|Outcome|Control|Participants receive standard medical care.
729584|NCT01696994|E1|Reported Event|Ovarian Screening|Participants undergo blood sample collection for CA125 analysis at baseline annually for 5 years. Participants also undergo an OVR (discontinued in December 1998) and TVU at baseline and annually for 3 years.
729585|NCT01696981|B3|Baseline|Total|Total of all reporting groups
729586|NCT01696981|B2|Baseline|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729587|NCT01696981|B1|Baseline|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729588|NCT01696981|P2|Participant Flow|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729589|NCT01696981|P1|Participant Flow|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729609|NCT01696968|P2|Participant Flow|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729610|NCT01696968|P1|Participant Flow|Control|Participants receive standard medical care.
729590|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729591|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729592|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729593|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729594|NCT01696981|O1|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729595|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729596|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729597|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729598|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729599|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729600|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729601|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729602|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729603|NCT01696981|O2|Outcome|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729604|NCT01696981|O1|Outcome|Control|Participants receive standard medical care. Participants complete a baseline questionnaire at entry and a dietary history questionnaire (DHQ) during study years 0-6.
729605|NCT01696981|E1|Reported Event|Colorectal Screening|Participants undergo a colorectal examination with a flexible sigmoidoscope at baseline and year 5. Participants complete a Dietary Questionnaire (DQX) at baseline and a Dietary History Questionnaire (DHQ) at study years 3-6. An Annual Study Update (ASU) (previously referred to as the Periodic Survey of Health [PSH] questionnaire) is mailed to each participant annually for 13 years to identify all prevalent and incident colorectal cancers and all deaths that occur among both screened and control arm subjects during the trial.
729606|NCT01696968|B3|Baseline|Total|Total of all reporting groups
729607|NCT01696968|B2|Baseline|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729608|NCT01696968|B1|Baseline|Control|Participants receive standard medical care.
729639|NCT01696773|O2|Outcome|Red Tomato Juice|"Red tomato juice will be fed~Red tomato juice: Post-prandial feeding study"
729611|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729612|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729613|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729614|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
729615|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729616|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729617|NCT01696968|O1|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729618|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729619|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
729620|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729621|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
729622|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729623|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
729624|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (postero-anterior view chest radiograph) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729625|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
729626|NCT01696968|O2|Outcome|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729627|NCT01696968|O1|Outcome|Control|Participants receive standard medical care.
729628|NCT01696968|E1|Reported Event|Lung Screening|"Participants undergo a chest x-ray (one postero-anterior view) at baseline and annually for 2 years. Participants classified as smokers undergo an additional chest x-ray at year 3."
729652|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
730939|NCT01689441|E2|Reported Event|Placebo|"Normal saline 2cc IV x 1~Placebo"
729629|NCT01696929|B1|Baseline|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
729630|NCT01696929|P1|Participant Flow|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of Tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of Tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacological Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
729631|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
729632|NCT01696929|O1|Outcome|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
729633|NCT01696929|E1|Reported Event|Tocilizumab|"Following a screening evaluation, participants will receive two infusions of tocilizumab, one at baseline and another at week 4 of the study. All subjects will receive a 4 mg/kg infusion of tocilizumab, the recommended starting dose for adults with rheumatoid arthritis.~Tocilizumab: Therapeutic/Pharmacologic Class of Drug:~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.~Type of Dosage Form:~Concentrate for solution for infusion.~Route of Administration:~Intravenous (i.v.) infusion."
729634|NCT01696773|B3|Baseline|Total|Total of all reporting groups
729635|NCT01696773|B2|Baseline|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice is consumed on day 14, then tangerine tomato juice on day 28
729636|NCT01696773|B1|Baseline|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice is consumed on day 14 then red tomato juice on day 28
729637|NCT01696773|P2|Participant Flow|Red Tomato Juice First, Then Tangerine Tomato Juice|Red tomato juice will be fed, followed by a 14 day washout, then tangerine tomato juice will be fed.
729638|NCT01696773|P1|Participant Flow|Tangerine Tomato Juice First, Then Red Tomato Juice|Tangerine tomato juice will be fed, followed by a 14 day washout, and then red tomato juice will be fed
729642|NCT01696773|E1|Reported Event|Tangerine Tomato Juice|"Tangerine tomato juice will be fed~Tangerine tomato juice: Post-prandial feeding study"
729643|NCT01696760|B3|Baseline|Total|Total of all reporting groups
729644|NCT01696760|B2|Baseline|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729645|NCT01696760|B1|Baseline|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729646|NCT01696760|P2|Participant Flow|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729647|NCT01696760|P1|Participant Flow|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729648|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729649|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729650|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729651|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729748|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729653|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729654|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729655|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729656|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729657|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729658|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729659|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729660|NCT01696760|O2|Outcome|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729661|NCT01696760|O1|Outcome|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729789|NCT01695772|B1|Baseline|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729662|NCT01696760|E2|Reported Event|Arm II (Enoxaparin and PCD)|"Patients receive enoxaparin subcutaneously SC QD and wear PCD on days 1-28 after surgery.~enoxaparin: 40 mg once daily~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729663|NCT01696760|E1|Reported Event|Arm I (Acetylsalicylic Acid and PCD)|"Patients receive acetylsalicylic acid orally PO BID and wear PCD on days 1-28 after surgery.~acetylsalicylic acid: 325 mg twice a day~PCD: Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study."
729664|NCT01696695|B1|Baseline|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729665|NCT01696695|P1|Participant Flow|Metastatic Colorectal Carcinoma (mCRC) Participants|Newly diagnosed metastatic colorectal carcinoma (mCRC) participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729666|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729667|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729668|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729669|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729749|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729670|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729671|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729672|NCT01696695|O1|Outcome|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729673|NCT01696695|E1|Reported Event|mCRC Participants|Newly diagnosed mCRC participants, who received first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, were observed. The choice of therapy was based on exclusively the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
729674|NCT01696643|B3|Baseline|Total|Total of all reporting groups
729675|NCT01696643|B2|Baseline|Placebo|Placebo, administered orally, BID for 52 weeks
729676|NCT01696643|B1|Baseline|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729677|NCT01696643|P2|Participant Flow|Placebo|Placebo, administered orally, BID for 52 weeks
729678|NCT01696643|P1|Participant Flow|CB-5945|0.25 milligrams (mg) CB-5945, administered orally, twice daily (BID) for 52 weeks
729679|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
729680|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729681|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729682|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
729683|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729684|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
729685|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729686|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
729687|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729688|NCT01696643|O2|Outcome|Placebo|Placebo, administered orally, BID for 52 weeks
729689|NCT01696643|O1|Outcome|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729690|NCT01696643|E2|Reported Event|Placebo|Placebo, administered orally, BID for 52 weeks
729691|NCT01696643|E1|Reported Event|CB-5945|0.25 mg CB-5945, administered orally, BID for 52 weeks
729692|NCT01696357|B3|Baseline|Total|Total of all reporting groups
730061|NCT01694108|O2|Outcome|Control Children|No intervention
729693|NCT01696357|B2|Baseline|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729694|NCT01696357|B1|Baseline|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729695|NCT01696357|P2|Participant Flow|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729696|NCT01696357|P1|Participant Flow|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729697|NCT01696357|O2|Outcome|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729751|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729698|NCT01696357|O1|Outcome|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729699|NCT01696357|E2|Reported Event|Adolescents Without Asthma|"Ages 13-17 without an asthma diagnosis and without any other respiratory condition that presents with asthma-like symptoms.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729700|NCT01696357|E1|Reported Event|Adolescents With Asthma|"Ages 13-17 with an asthma diagnosis-both symptomatic and non-symptomatic- and with currently prescribed asthma medication.~Automated Device for Asthma Monitoring (ADAM): Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device."
729701|NCT01696214|B5|Baseline|Total|Total of all reporting groups
729702|NCT01696214|B4|Baseline|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
729703|NCT01696214|B3|Baseline|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
729704|NCT01696214|B2|Baseline|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
729705|NCT01696214|B1|Baseline|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
729706|NCT01696214|P4|Participant Flow|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, placebo ipratropium, and placebo montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
730062|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
730063|NCT01694108|O2|Outcome|Control Children|No intervention
729707|NCT01696214|P3|Participant Flow|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and placebo ipratropium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
729708|NCT01696214|P2|Participant Flow|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and placebo montelukast.~Theophylline: Participants will be assigned to theophylline 400 mg once a day for 24 weeks"
729709|NCT01696214|P1|Participant Flow|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and placebo montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
729710|NCT01696214|O4|Outcome|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250/salmeterol 50 twice a day for 24 weeks with placebo theophylline, ipratropium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg: Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo"
729711|NCT01696214|O3|Outcome|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and ipratropium.~Montelukast 10mg: Participants will be assigned to Leukotriene receptor antagonist once a day for 24 weeks."
729712|NCT01696214|O2|Outcome|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 400 mg once a day for 24 weeks with placebo ipratropium and montelukast.~Theophylline 400 mg: Participants will be assigned to Theophylline once a day for 24 weeks"
729713|NCT01696214|O1|Outcome|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 2.5 mL, 0.02% 3 times daily via mini nebulizer with placebo theophylline and montelukast.~ipratropium: Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks."
729714|NCT01696214|E4|Reported Event|Fluticasone 250 mg/Salmeterol 50mg|"Participants will be assigned to inhaled fluticasone 250 mg/salmeterol 50 mg twice a day for 24 weeks with placebo theophylline, tiotroprium, and montelukast.~Fluticasone 250 mg/salmeterol 50 mg:~Participants will be assigned to a 24 week treatment with inhaled fluticasone 250 mg /salmeterol 50"
729715|NCT01696214|E3|Reported Event|Montelukast|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to montelukast 10 mg once a day for 24 weeks with placebo theophylline and tiotroprium.~Montelukast 10mg: Participants will be assigned to montelukast 10 mg once a day for 24 weeks."
729750|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729716|NCT01696214|E2|Reported Event|Theophylline|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and will be assigned to theophylline 300 mg once a day for 24 weeks with placebo tiotroprium and montelukast.~Theophylline: Participants will be assigned to theophylline 300 mg once a day for 24 weeks"
729717|NCT01696214|E1|Reported Event|Ipratropium|"Participants will continue fluticasone 100 mg/salmeterol 50 mg once a day and be assigned to a 24 week treatment of ipratropium 0.02% solution, 2.5 ml via mini nebulizer for 24 weeks with placebo theophylline and montelukast.~Ipratropium: Participants will be assigned to ipratropium 0.02% solution, 2.5 ml via mini nebulizer 3 times"
729718|NCT01696188|B3|Baseline|Total|Total of all reporting groups
729719|NCT01696188|B2|Baseline|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plan approach.~interscalene nerve catheter"
729720|NCT01696188|B1|Baseline|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
729721|NCT01696188|P2|Participant Flow|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
729722|NCT01696188|P1|Participant Flow|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
729723|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
729724|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
729725|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
729726|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
729727|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
729728|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
729729|NCT01696188|O2|Outcome|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
729730|NCT01696188|O1|Outcome|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
729731|NCT01696188|E2|Reported Event|Out-of-plane Group|"This group will receive an interscalene catheter with an out-of-plane approach.~interscalene nerve catheter"
729732|NCT01696188|E1|Reported Event|In-plane Group|"This group will receive an interscalene catheter placed with in-plane approach.~interscalene nerve catheter"
729733|NCT01696071|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
729734|NCT01696071|P2|Participant Flow|Tio R5 QD / Tio R2.5 BID|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg) Treatment 2: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg)"
730064|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
730065|NCT01694108|O2|Outcome|Control Children|No intervention
729735|NCT01696071|P1|Participant Flow|Tio R2.5 Twice Daily (BID) / Tio R5 Once Daily (QD)|"Subjects were randomised to receive treatment with 2.5 μg tiotropium inhalation solution twice daily (i.e. in the morning and in the evening) and 5 μg tiotropium inhalation solution once daily in the evening via Respimat inhaler in a crossover manner using a predefined randomisation sequence.~Treatment 1: Tio 2.5 µg BID (twice daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 2.5 µg twice daily i.e 2 actuations of 1.25 µg tiotropium in the morning and in the evening (total daily dose of 5 μg) Treatment 2: Tio 5 µg QD (once daily):Oral inhalation via the( Tiotropium–Respimat) inhaler of 5 µg once daily i.e 2 actuations of 2.5 µg tiotropium in the evening and 2 actuations of placebo in the morning (total daily dose of 5 μg)"
729736|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729737|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729738|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729739|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729740|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729741|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729742|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729743|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729744|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729745|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729746|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729747|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729840|NCT01695304|O2|Outcome|Control Group|Control Group who did not receive ceramic water filters (until after the trial ended)
729752|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729753|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729754|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729755|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729756|NCT01696071|O2|Outcome|Tio R5 QD|Tiotropium 5 mcg QD in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729757|NCT01696071|O1|Outcome|Tio R2.5 BID|Tiotropium 2.5 mcg BID morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with inhaled corticosteroid (iCS).
729758|NCT01696071|E2|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729759|NCT01696071|E1|Reported Event|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top of maintenance therapy with iCS.
729760|NCT01696058|B3|Baseline|Total|Total of all reporting groups
729761|NCT01696058|B2|Baseline|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729762|NCT01696058|B1|Baseline|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
729763|NCT01696058|P2|Participant Flow|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729764|NCT01696058|P1|Participant Flow|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
729765|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729766|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
730066|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
730067|NCT01694108|O2|Outcome|Control Children|No intervention
729767|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729768|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729769|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729770|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729771|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729772|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729773|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729774|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729775|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729776|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729777|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729778|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729779|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729780|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729781|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729782|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729783|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729784|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729785|NCT01696058|O2|Outcome|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729786|NCT01696058|O1|Outcome|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729787|NCT01696058|E2|Reported Event|Placebo and Tiotropium (18μg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729788|NCT01696058|E1|Reported Event|Olodaterol (5μg) and Tiotropium (18μg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729790|NCT01695772|P1|Participant Flow|Bevacizumab|Participants received standard 5-Flurouracil (5-FU) based chemotherapy plus bevacizumab 5 milligrams per kilograms (mg/kg) intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729791|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729792|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729793|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729794|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729795|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729796|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729797|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729798|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729799|NCT01695772|O1|Outcome|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729800|NCT01695772|E1|Reported Event|Bevacizumab|Participants received standard 5-FU based chemotherapy plus bevacizumab 5 mg/kg intravenous infusion every two week cycle for a maximum of 12 cycles unless they experienced progressive disease, unacceptable toxicities or participant refusal.
729841|NCT01695304|O1|Outcome|Intervention Group|Intervention group who received ceramic water filters
729842|NCT01695304|O2|Outcome|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
729801|NCT01695746|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729802|NCT01695746|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729803|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729804|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729805|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729806|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729807|NCT01695746|O1|Outcome|C.E.R.A (Continuous Erythropoietin Receptor Activator)|Participants with chronic renal anemia Stage III-IV, not on dialysis, receiving therapy with C.E.R.A. according to routine clinical practice were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 μg/kg of C.E.R.A once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 μg either once monthly; or 60, 100, or 180 μg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729808|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729809|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729810|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729862|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729811|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729812|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729813|NCT01695746|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729814|NCT01695746|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia Stage III-IV, not on dialysis, were administered C.E.R.A. according to routine clinical practice and were followed for the treatment duration of 24 weeks (6 months). Dosing and titration of C.E.R.A. treatment was at the discretion of the investigator in accordance with local clinical practice or prescribing information. Dosing instructions as per the local label were - For correction of anemia: 0.6 mcg/kg of C.E.R.A. once every two weeks, and for Maintenance of Hb levels: Conversion to C.E.R.A. dose (120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks) depending on the previous weekly epoetin or darbepoetin dose.
729815|NCT01695668|B3|Baseline|Total|Total of all reporting groups
729816|NCT01695668|B2|Baseline|Restasis|Cyclosporine
729817|NCT01695668|B1|Baseline|Lotemax|Loteprednol Etabonate 0.5%
729818|NCT01695668|P2|Participant Flow|Restasis|Cyclosporine
729819|NCT01695668|P1|Participant Flow|Lotemax|Loteprednol Etabonate 0.5%
729820|NCT01695668|O2|Outcome|Restasis|Cyclosporine
729821|NCT01695668|O1|Outcome|Lotemax|Loteprednol Etabonate 0.5%
729822|NCT01695668|E2|Reported Event|Restasis|"Cyclosporine~Restasis"
729823|NCT01695668|E1|Reported Event|Lotemax|"Loteprednol Etabonate 0.5%~Lotemax"
729824|NCT01695369|B1|Baseline|Overall Study Participants|Senofilcon A and Comfilcon A
729825|NCT01695369|P1|Participant Flow|Overall Study Participants|Senofilcon A and Comfilcon A
729826|NCT01695369|O2|Outcome|Senofilcon A|Senofilcon A (Vistakon Acuvue® Oasys)
729827|NCT01695369|O1|Outcome|Comfilcon A|comfilcon A (CooperVision Biofinity®Sphere)
729828|NCT01695369|E2|Reported Event|Comfilcon A|Comfilcon A / CooperVision Biofinity Sphere
729829|NCT01695369|E1|Reported Event|Overall Study Participants|Senofilcon A and Comfilcon A
729830|NCT01695330|B1|Baseline|Subcutaneous Bortezomib|
729831|NCT01695330|P2|Participant Flow||This is one-arm study.
730068|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
730069|NCT01694108|O2|Outcome|Control Children|No intervention
729832|NCT01695330|P1|Participant Flow|Subcutaneous Bortezomib|patients with MM who received treatment with a SC bortezomib-containing combination. The patients were required to have received a prior IV bortezomib containing combination regimen that differs from the SC bortezomib-containing treatment.
729833|NCT01695330|O1|Outcome|Subcutaneous Bortezomib|Patients with MM who received treatment with a SC bortezomib-containing combination
729834|NCT01695330|E1|Reported Event|Subcutaneous Bortezomib|Bortezomib was administered SC at a dose of 1.0 mg/m2. Doses were administered on days 1, 4, 8, and 11 of a 28-day cycle. When administered subcutaneously, sites for each injection (thigh or abdomen) were rotated and reported. All other drugs used in combination with the SC bortezomib were recorded in the Case Report Forms along with their corresponding doses and schedules.
729835|NCT01695304|B3|Baseline|Total|Total of all reporting groups
729836|NCT01695304|B2|Baseline|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
729837|NCT01695304|B1|Baseline|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
729838|NCT01695304|P2|Participant Flow|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
729839|NCT01695304|P1|Participant Flow|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
729843|NCT01695304|O1|Outcome|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
729844|NCT01695304|E2|Reported Event|Control Arm|Households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
729845|NCT01695304|E1|Reported Event|Intervention Arm|"Households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water.~Ceramic water filter: In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends."
729846|NCT01695239|B5|Baseline|Total|Total of all reporting groups
729847|NCT01695239|B4|Baseline|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729848|NCT01695239|B3|Baseline|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729849|NCT01695239|B2|Baseline|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729850|NCT01695239|B1|Baseline|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729851|NCT01695239|P4|Participant Flow|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729852|NCT01695239|P3|Participant Flow|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab (ixe) Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729853|NCT01695239|P2|Participant Flow|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729854|NCT01695239|P1|Participant Flow|Placebo|Participants received placebo for ixekizumab as 2 subcutaneous (SC) injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections every 2 weeks (Q2W) from Week 2 to Week 24.
729855|NCT01695239|O3|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729856|NCT01695239|O2|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729857|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729858|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729859|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729860|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729861|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729945|NCT01695044|P1|Participant Flow|Arm 1: PSMA ADC|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
729863|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729864|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729865|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729866|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729867|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729868|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729869|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729870|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729871|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729872|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729873|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729874|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729875|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729876|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729877|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729878|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729879|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729880|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729881|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729882|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
730007|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
729883|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729884|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729885|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729886|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729887|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729888|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729889|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729890|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729891|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729892|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
730070|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
729893|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729894|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729895|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729896|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729897|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729898|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729899|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729900|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729901|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729902|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729903|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729904|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729905|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729906|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729907|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729908|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729909|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729910|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729911|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729912|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
730071|NCT01694108|O2|Outcome|Control Children|No intervention
729913|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729914|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729915|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729916|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729917|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729918|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729919|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729920|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729921|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729922|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729923|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729924|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729925|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729926|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729927|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729928|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729929|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729930|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729931|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729932|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
730072|NCT01694108|O1|Outcome|BCG-vaccine|SS! strain 1331 standard dose
729933|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729934|NCT01695239|O4|Outcome|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729935|NCT01695239|O3|Outcome|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729936|NCT01695239|O2|Outcome|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729937|NCT01695239|O1|Outcome|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729938|NCT01695239|E4|Reported Event|Ixekizumab Q2W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729939|NCT01695239|E3|Reported Event|Ixekizumab Q4W|Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections of 80 mg and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Participants received one SC injection of 80 mg of ixekizumab or placebo for ixekizumab Q2W from Week 2 to Week 24. Participants received one SC injection of placebo for adalimumab Q2W from Week 2 to Week 24.
729940|NCT01695239|E2|Reported Event|Adalimumab Q2W|Participants received 40 mg of adalimumab as one SC injection and placebo for ixekizumab as 2 SC injections for a total of 3 injections at Week 0. Participants received one SC injection of 40 mg of adalimumab and one SC injection of placebo for ixekizumab Q2W from Week 2 to Week 24.
729941|NCT01695239|E1|Reported Event|Placebo|Participants received placebo for ixekizumab as 2 SC injections and placebo for adalimumab as one SC injection for a total of 3 injections at Week 0. Placebo for ixekizumab and placebo for adalimumab were given as single SC injections Q2W from Week 2 to Week 24.
729942|NCT01695044|B3|Baseline|Total|Total of all reporting groups
729943|NCT01695044|B2|Baseline|Arm 2: PSMA ADC Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.
729944|NCT01695044|B1|Baseline|Arm 1: PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
729946|NCT01695044|O2|Outcome|Chemotherapy-naive|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
729947|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
729948|NCT01695044|O2|Outcome|Chemotherapy-naive|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
729949|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
729950|NCT01695044|O2|Outcome|Chemotherapy-naive|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it."
729951|NCT01695044|O1|Outcome|PSMA ADC Chemotherapy-experienced|"Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) administered IV at 2.3 mg/kg Q3W for 8 cycles.~The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation)."
729952|NCT01695044|E2|Reported Event|Chemotherapy-naive|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-naïve group was comprised of 35 subjects who were cytotoxic chemotherapy-naïve. Chemotherapy-naïve subjects must have received and progressed on Radium-223 (following its approval by FDA), or have been ineligible for it, refused it, had an intolerance to it, or did not have access to it.
729953|NCT01695044|E1|Reported Event|PSMA ADC Chemotherapy-experienced|PSMA ADC administered IV at 2.3 mg/kg Q3W for 8 cycles. The chemotherapy-experienced group was comprised of 84 subjects who must have received at least one taxane-containing chemotherapy regimen (e.g., docetaxel, cabazitaxel) prior to the study (more than two cytotoxic chemotherapy regimens required sponsor approval for study participation).
729954|NCT01694771|B3|Baseline|Total|Total of all reporting groups
730073|NCT01694108|O2|Outcome|Control Children|No intervention
730074|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
729955|NCT01694771|B2|Baseline|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729956|NCT01694771|B1|Baseline|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
729957|NCT01694771|P2|Participant Flow|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729958|NCT01694771|P1|Participant Flow|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose~Tiotropium: Marketed dose"
729959|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729960|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729961|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729962|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729963|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729964|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729965|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
730008|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
730009|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
730010|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
729966|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729967|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729968|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729969|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729970|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729971|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729972|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729973|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729974|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729975|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729976|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
730075|NCT01694108|O2|Outcome|Control Children|No intervention
730076|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
729977|NCT01694771|O2|Outcome|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729978|NCT01694771|O1|Outcome|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729979|NCT01694771|E2|Reported Event|Placebo and Tiotropium (18µg)|"2 puffs placebo inhalation solution from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning~Placebo matching Olodaterol: One dose, 2 inhalations once daily in the morning"
729980|NCT01694771|E1|Reported Event|Olodaterol (5µg) and Tiotropium (18µg)|"2 puffs olodaterol from Respimat and one capsule tiotropium from Handihaler once daily in am, co-administered~Olodaterol: One dose, 2 inhalations once daily in the morning~Tiotropium: Marketed dose, 2 inhalations from 1 capsule once daily in the morning"
729981|NCT01694706|B1|Baseline|Entire Study Population|"All subjects received all tested treatments in a randomised, open label, 3-way cross over study. The treatments were:~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Drug administrations were separated by a washout period of at least 14 days"
729982|NCT01694706|P3|Participant Flow|Faldaprevir+ OMP/ Faldaprevir Fed/ Faldaprevir|"Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration"
730011|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
730012|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
730013|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
730014|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
730015|NCT01694667|E2|Reported Event|Placebo|Participants randomized to placebo
729983|NCT01694706|P2|Participant Flow|Faldaprevir Fed/ Faldaprevir/ Faldaprevir+ OMP|"Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less.~Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)~faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir."
729984|NCT01694706|P1|Participant Flow|Faldaprevir/Faldaprevir+ OMP/Faldaprevir Fed|"Faldaprevir: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration.~Faldaprevir+ OMP: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir.~Faldaprevir fed: Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less."
729985|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
729986|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
729987|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
729988|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
729989|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
729990|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
729991|NCT01694706|O3|Outcome|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast prior the drug administration following multiple dosing of 40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
729992|NCT01694706|O2|Outcome|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
730077|NCT01694108|O2|Outcome|Control Children|No intervention
730078|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
729993|NCT01694706|O1|Outcome|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
729994|NCT01694706|E4|Reported Event|Omeprazole|40 mg omeprazole once daily for 4 days prior the first dose of faldaprevir
729995|NCT01694706|E3|Reported Event|Faldaprevir and Omeprazole|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was coadministered orally with 40 mg Omeprazole following an overnight or at least 10 hours (h) fast
729996|NCT01694706|E2|Reported Event|Faldaprevir After a High-fat Meal|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally 30 minutes (min) after a standard high-fat, high-caloric meal was served. The meal had to be completely consumed within 25 min or less
729997|NCT01694706|E1|Reported Event|Faldaprevir in Fasting|Single dose of 240 mg faldaprevir in a form of two soft gelatin capsules was administered orally following an overnight or at least 10 hours (h) fast prior the drug administration (Reference treatment)
729998|NCT01694667|B3|Baseline|Total|Total of all reporting groups
729999|NCT01694667|B2|Baseline|Placebo|Participants randomized to placebo
730000|NCT01694667|B1|Baseline|Omega-3|Participants randomized to omega-3
730001|NCT01694667|P2|Participant Flow|Placebo|"Placebo packets will have same orange-flavored pudding with an identical appearance and taste, but will include safflower oil instead of the fish oil.~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~28 participants allocated to this group."
730002|NCT01694667|P1|Participant Flow|Omega-3 Fatty Acids|"Omega-3 fatty acids will be delivered in orange-flavored pudding packets and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~Omega-3 Fatty Acids: Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).~29 participants allocated to this group."
730003|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
730004|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
730005|NCT01694667|O2|Outcome|Placebo|Participants randomized to placebo
730006|NCT01694667|O1|Outcome|Omega-3|Participants randomized to omega-3
730018|NCT01694641|B2|Baseline|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
730019|NCT01694641|B1|Baseline|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
730020|NCT01694641|P2|Participant Flow|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
730021|NCT01694641|P1|Participant Flow|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
730022|NCT01694641|O2|Outcome|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
730023|NCT01694641|O1|Outcome|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
730024|NCT01694641|E2|Reported Event|Standard Embryo Monitoring|Upon fertilization embryos are observed once on days 1-3-5 by the embryologist to check for development. The single embryo for transfer is selected based on actual morphology as seen under light microscope.
730079|NCT01694108|O2|Outcome|Control Children|No intervention
730080|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
730081|NCT01694108|O2|Outcome|Control Children|No intervention
730082|NCT01694108|O1|Outcome|BCG-vaccine|SSI strain 1331 standard dose
730025|NCT01694641|E1|Reported Event|Time Lapse Embryo Observation|"Embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse: upon fertilization embryos are placed in an incubator that is hooked up to a monitor that allows continuous embryo observation. A morpho-kinetic TL algorithm (made up of standard moprhology as seen on time lapse and kinetci scores) is used for embryo selection.~time-lapse morphokinetic evaluation: embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse"
730026|NCT01694420|B1|Baseline|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730027|NCT01694420|P1|Participant Flow|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730028|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730029|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730030|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730031|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730032|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730033|NCT01694420|O1|Outcome|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730034|NCT01694420|E1|Reported Event|Quad FDC|"FDC elvitegravir + cobicistat + tenofovir + emtricitabine STR once daily for 48 weeks~(FDC) ELV/COBI/FTC/TDF: Antiretroviral treatment"
730035|NCT01694199|B3|Baseline|Total|Total of all reporting groups
730036|NCT01694199|B2|Baseline|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730037|NCT01694199|B1|Baseline|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730038|NCT01694199|P2|Participant Flow|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730039|NCT01694199|P1|Participant Flow|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730040|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730041|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730531|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730042|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730043|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730044|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730045|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730046|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730047|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730048|NCT01694199|O2|Outcome|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730049|NCT01694199|O1|Outcome|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730050|NCT01694199|E2|Reported Event|Sham Study Device With no PRFE|"This study arm receives no pulsed radiofrequency energy (PRFE) from a sham test device.~No Pulsed Radiofrequency Energy (PRFE): Sham (placebo) with no therapeutic device activity"
730051|NCT01694199|E1|Reported Event|Active Study Device With PRFE|"This study arm receives pulsed radiofrequency energy (PRFE) from an active test device.~Pulsed Radiofrequency Energy (PRFE): The intervention is pulsed radiofrequencyenergy (PRFE)."
730052|NCT01694108|B3|Baseline|Total|Total of all reporting groups
730053|NCT01694108|B2|Baseline|Control Children|No intervention
730054|NCT01694108|B1|Baseline|BCG-vaccine|SSI strain 1331 standard dose
730055|NCT01694108|P2|Participant Flow|Control Children (no Intervention)|
730056|NCT01694108|P1|Participant Flow|BCG-vaccine|
730057|NCT01694108|O2|Outcome|Face-to-face|Randomized to receive information about the study by standard face-to-face consultation.
730058|NCT01694108|O1|Outcome|Telephone|Randomized to receive information about the study by telephone
730059|NCT01694108|O2|Outcome|Declining Mothers|Mothers who decided not to let their child participate in the study
730060|NCT01694108|O1|Outcome|Participating Mothers|Mothers who decided to let their child participate in the study
730110|NCT01693900|B2|Baseline|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
730111|NCT01693900|B1|Baseline|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
730112|NCT01693900|P2|Participant Flow|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
730113|NCT01693900|P1|Participant Flow|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
730114|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
730115|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
730162|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730116|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
730117|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
730118|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
730119|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
730120|NCT01693900|O2|Outcome|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
730121|NCT01693900|O1|Outcome|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
730150|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730122|NCT01693900|E2|Reported Event|Intra-operative FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room.~Intra-operative FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB."
730123|NCT01693900|E1|Reported Event|Pre-operative Ultrasound FICB Group|"Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area.~Pre-operative Ultrasound FICB Group: 25 subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under an ultrasound guidance device with an in-plane technique by a single study investigator, in the preoperative area."
730124|NCT01693653|B3|Baseline|Total|Total of all reporting groups
730125|NCT01693653|B2|Baseline|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730126|NCT01693653|B1|Baseline|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730127|NCT01693653|P2|Participant Flow|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730128|NCT01693653|P1|Participant Flow|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730129|NCT01693653|O2|Outcome|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730130|NCT01693653|O1|Outcome|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730131|NCT01693653|E2|Reported Event|Placebo|"placebo infusion 0.9% sodium chloride every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730132|NCT01693653|E1|Reported Event|Tocilizumab|"tocilizumab infusion every 4 weeks over 3 months~Tocilizumab: Intravenous infusions every 4 weeks for 3 doses."
730133|NCT01693484|B1|Baseline|Operative Calcaneus Fracture|Patients with indications for and electing to undergo operative repair of intra articular calcaneus fracture through extended lateral approach
730134|NCT01693484|P1|Participant Flow|Displaced Intra Articular Calcaneus Fracture|displaced intra articular calcaneus fracture with operative repair
730163|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730203|NCT01692782|B2|Baseline|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 8mg once daily"
730135|NCT01693484|O1|Outcome|ICG Administered|"The ICG dose (10 mg/4cc per image capture) will be administered in its entirety via push injection through IV access established for standard surgical procedure, followed by 10 cc Normal Saline bolus. This ICG dose will be administered twice, 1X prior to anesthesia, and 1X after the tourniquet on operative extremity has been removed for at least 15 minutes.~ICG (Indocyanine Green): Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency."
730136|NCT01693484|E1|Reported Event|Unanticipated Adverse Events Related to ICG|No adverse events related to administration ICG
730137|NCT01693367|B3|Baseline|Total|Total of all reporting groups
730138|NCT01693367|B2|Baseline|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730139|NCT01693367|B1|Baseline|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730140|NCT01693367|P2|Participant Flow|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730141|NCT01693367|P1|Participant Flow|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730142|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730143|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730144|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730145|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730146|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730147|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730148|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730149|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730363|NCT01691560|E4|Reported Event|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730151|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730152|NCT01693367|O2|Outcome|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730153|NCT01693367|O1|Outcome|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730154|NCT01693367|E2|Reported Event|SLS (Standard Locking Screw)|"ORIF with SLS (Standard locking screw)~SLS (Standard locking screw): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)"
730155|NCT01693367|E1|Reported Event|DLS 5.0 (Dynamic Locking Screws)|"ORIF with DLS 5.0 (Dynamic Locking Screws)~DLS 5.0 (Dynamic locking screws): Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0"
730156|NCT01693185|B3|Baseline|Total|Total of all reporting groups
730157|NCT01693185|B2|Baseline|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730158|NCT01693185|B1|Baseline|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730159|NCT01693185|P2|Participant Flow|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730160|NCT01693185|P1|Participant Flow|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730161|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730194|NCT01692938|P1|Participant Flow|No Retinal Disease|
730164|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730165|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730166|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730167|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730168|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730169|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730170|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730171|NCT01693185|O2|Outcome|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730172|NCT01693185|O1|Outcome|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730173|NCT01693185|E2|Reported Event|Midazolam and Meperidine|"a bolus midazolam of 0.03 mg/kg a bolus meperidine of 1.0 mg/kg placebo (for remifentanil)~Midazolam: bolus injection~Meperidine: bolus injection for 30 sec 1.0 mg/kg~placebo (for remifentanil): normal saline mimic diluted remifentanil"
730174|NCT01693185|E1|Reported Event|Remifentanil|"remifentanil of 0.04 mcg/kg/min with placebo (for midazolam) and placebo (for meperidine)~Remifentanil: continuous infusion 0.4 mcg/kg/min~placebo (for midazolam): normal saline mimic to midazolam injection~placebo (for meperidine): normal saline mimic meperidine injection"
730175|NCT01693029|B3|Baseline|Total|Total of all reporting groups
730176|NCT01693029|B2|Baseline|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
730364|NCT01691560|E3|Reported Event|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730177|NCT01693029|B1|Baseline|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
730178|NCT01693029|P2|Participant Flow|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
730179|NCT01693029|P1|Participant Flow|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
730180|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
730181|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
730182|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
730183|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
730184|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
730185|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
730186|NCT01693029|O2|Outcome|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
730187|NCT01693029|O1|Outcome|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
730188|NCT01693029|E2|Reported Event|US-licensed Epoetin Alfa|"US-licensed recombinant human epoetin alfa~US-licensed epoetin alfa: Solution for subcutaneous injection."
730189|NCT01693029|E1|Reported Event|HX575 Epoetin Alfa|"HX575, recombinant human epoetin alfa~HX575 epoetin alfa: Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL."
730190|NCT01692938|B3|Baseline|Total|Total of all reporting groups
730191|NCT01692938|B2|Baseline|Retinal Disease|
730192|NCT01692938|B1|Baseline|No Retinal Disease|
730193|NCT01692938|P2|Participant Flow|Retinal Disease|
730204|NCT01692782|B1|Baseline|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily"
730205|NCT01692782|P3|Participant Flow|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730206|NCT01692782|P2|Participant Flow|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730207|NCT01692782|P1|Participant Flow|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730208|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730209|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730210|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730211|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730212|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730213|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730214|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730215|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730216|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730217|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730218|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730219|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730220|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730221|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730222|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730223|NCT01692782|O3|Outcome|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730224|NCT01692782|O2|Outcome|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730225|NCT01692782|O1|Outcome|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730226|NCT01692782|E3|Reported Event|Placebo|"4 capsules of placebo~Placebo: Placebo once daily"
730227|NCT01692782|E2|Reported Event|SEP-225289 8mg|"SEP-225289 8mg once daily taken as a combination of SEP-225289 2mg and placebo to achieve 8mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730228|NCT01692782|E1|Reported Event|SEP-225289 4mg|"SEP-225289 4mg once daily taken as a combination of SEP-225289 2mg and placebo capsules to achieve 4mg QD doses~SEP-225289: SEP-225289 4mg once daily~SEP-225289: SEP-225289 8mg once daily"
730229|NCT01692691|B1|Baseline|Number of Participants|Dacarbazine Carmustine
730230|NCT01692691|P1|Participant Flow|Dacarbazine Carmustine|All patients received chemotherapy with Dacarbazine and Carmustine
730231|NCT01692691|O1|Outcome|Response Rate|Dacarbazine Carmustine
730232|NCT01692691|O1|Outcome|Progression Free Survival at 8 Weeks|Dacarbazine + Carmustine
730233|NCT01692691|E1|Reported Event|Number of Participants|Dacarbazine Carmustine
730234|NCT01692626|B1|Baseline|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
730235|NCT01692626|P2|Participant Flow|Right Side Investigational Cream / Placebo on Left Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
730264|NCT01692301|B1|Baseline|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730236|NCT01692626|P1|Participant Flow|Left Side Investigational Cream/Placebo Cream on Right Side|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
730237|NCT01692626|O2|Outcome|The Right Side the Pimecrolimus Cream|The right side of the face that the pimecrolimus cream was applied.
730238|NCT01692626|O1|Outcome|Left sidePimecrolimus Cream|The left side of the face that the Pimecrolimus Cream was applied.
730239|NCT01692626|E1|Reported Event|Investigational Cream/Placebo Cream|"Patients will apply a thin layer of the investigational cream twice daily for four weeks (unless rash worsens sooner) to one half of face at the same time the are started on cetuximab. Patients will be provided with a placebo cream to apply to the other side of their face. The study coordinator will instruct the patient regarding which side of the face to apply the investigational cream. This will be randomly assigned by the study coordinator based on a randomization list generated by the biostatistics core and will only be known to the study coordinator.~Pimecrolimus: Pimecrolimus 1% topical cream twice daily for four weeks."
730240|NCT01692340|B4|Baseline|Total|Total of all reporting groups
730241|NCT01692340|B3|Baseline|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730242|NCT01692340|B2|Baseline|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730243|NCT01692340|B1|Baseline|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730244|NCT01692340|P3|Participant Flow|Istotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730245|NCT01692340|P2|Participant Flow|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730246|NCT01692340|P1|Participant Flow|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730247|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730248|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730249|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730250|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730251|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730252|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730253|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730254|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730255|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730256|NCT01692340|O3|Outcome|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730257|NCT01692340|O2|Outcome|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730258|NCT01692340|O1|Outcome|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730259|NCT01692340|E3|Reported Event|Isotopically Labeled Phytofluene|"10 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730260|NCT01692340|E2|Reported Event|Isotopically Labeled Phytoene|"3.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730261|NCT01692340|E1|Reported Event|Isotopically Labeled Lycopene|"10.2 mg of labeled carotenoid with a controlled meal.~Consumption of an isotopically labeled carotenoid followed by pharmacokinetic studies for absorption and metabolism"
730262|NCT01692301|B3|Baseline|Total|Total of all reporting groups
730263|NCT01692301|B2|Baseline|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730265|NCT01692301|P2|Participant Flow|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730266|NCT01692301|P1|Participant Flow|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730267|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730268|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730269|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
733304|NCT01680159|E2|Reported Event|TA-650（Normal Dose Period）Plaque Psoriasis|Plaque Psoriasis
730270|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730271|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730272|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730273|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730274|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730275|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730276|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730277|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730940|NCT01689441|E1|Reported Event|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
730278|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730279|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730280|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730281|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730282|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730501|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730283|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730284|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730285|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730286|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730287|NCT01692301|O2|Outcome|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730288|NCT01692301|O1|Outcome|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730289|NCT01692301|E2|Reported Event|Olmesartan|Randomized patients received olmesartan once daily for four weeks, then force-titrated to a higher dose at Week 4 and stayed on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan) were given during the entire study.
730290|NCT01692301|E1|Reported Event|LCZ696 (Sacubitril/Valsartan)|Randomized patients received LCZ696 once daily for four weeks, then they force-titrated to a higher dose at Week 4 and stayed on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan matching placebo) were given during the entire study.
730291|NCT01691885|B1|Baseline|Per Protocol Population|All participants received placebo or FF/VI 100/25 µg in either of the two treatment periods QD, each morning from a DPI. Treatment periods lasted 7 days up to a maximum of 14 days for each period. The two treatments were separated by a wash out period of 7 days, up to a maximum of 9 days.
730292|NCT01691885|P2|Participant Flow|FF/VI Then Placebo|Participants entering Treatment Period 1 received FF/VI 100/25 µg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period, participants entered Treatment Period 2 and received matching placebo QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
730293|NCT01691885|P1|Participant Flow|Placebo Then FF/VI|Participants entering Treatment Period 1 received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days. Following Treatment Period 1, participants entered a washout period for 7 days, up to a maximum of 9 days. Following the washout period participants entered Treatment Period 2 and received Fluticasone Furoate/Vilanerol (FF/VI) 100/25 micrograms (µg), QD, each morning via a DPI for 7 days, up to a maximum of 14 days.
730294|NCT01691885|O2|Outcome|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
730295|NCT01691885|O1|Outcome|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
730296|NCT01691885|E2|Reported Event|FF/VI|Participants received FF/VI 100/25 μg QD, each morning via a DPI for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received FF/VI 100/25 μg in Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2. Participants that received placebo during Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2.
730559|NCT01691313|E2|Reported Event|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
730297|NCT01691885|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD), each morning via a dry powder inhaler (DPI) for a period of 7 days, up to a maximum of 14 days during one of the two Treatment Periods. Participants that received placebo in Treatment Period 1, crossed over after the washout period to receive FF/VI 100/25 μg during Treatment Period 2. Participants that received FF/VI 100/25 μg during Treatment Period 1, crossed over after the washout period to receive placebo during Treatment Period 2.
730298|NCT01691794|B4|Baseline|Total|Total of all reporting groups
730299|NCT01691794|B3|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730300|NCT01691794|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730301|NCT01691794|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730302|NCT01691794|P3|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730303|NCT01691794|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730304|NCT01691794|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730305|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730306|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730342|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730307|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730308|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730309|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730310|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730311|NCT01691794|O3|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730312|NCT01691794|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730313|NCT01691794|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730314|NCT01691794|E3|Reported Event|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: ≥40 kg)|Participants with baseline weight ≥40 kg received 300 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730315|NCT01691794|E2|Reported Event|Atazanavir, 200 mg + Ritonavir, 100 mg (Weight: 20 to <40 kg)|Participants with baseline weight of 20 to <40 kg received 200 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 NRTIs for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730316|NCT01691794|E1|Reported Event|Atazanavir, 150 mg + Ritonavir, 100 mg (Weight: 15 to <20 kg)|Participants with baseline weight of 15 to <20 kg received 150 mg of atazanavir plus 100 mg of ritonavir once daily with an optimized background therapy of 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 24 weeks. In countries without locally approved pediatric indication for atazanavir, patients may continue to receive study treatment, with regular 12-week visits, until the age of 18 years.
730317|NCT01691690|B3|Baseline|Total|Total of all reporting groups
730318|NCT01691690|B2|Baseline|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730319|NCT01691690|B1|Baseline|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730320|NCT01691690|P2|Participant Flow|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730321|NCT01691690|P1|Participant Flow|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730343|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730344|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730322|NCT01691690|O2|Outcome|Saline Placebo Infused Intraoperatively|"For this arm Morphine will be administered to manage pain.~Normal Saline Flush: Saline placebo will be infused intraoperatively.~Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.~Sevoflurane: Sevoflurane for anesthesia induction.~Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.~Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.~Morphine: Morphine 0.1 mg/kg given prior to intubation.~Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.~Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
730323|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction..~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg).~Midazolam: Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.~Sevoflurane: Sevoflurane for anesthesia induction.~Nitrous Oxide/Oxygen: Combination of NO2 & O2 for anesthesia induction.~Propofol: Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.~Morphine: Morphine 0.1 mg/kg given prior to intubation.~Ondansetron: Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.~Dexamethasone: Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis."
730324|NCT01691690|O2|Outcome|Saline Placebo Infused Intraoperatively|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730325|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730326|NCT01691690|O2|Outcome|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730365|NCT01691560|E2|Reported Event|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730327|NCT01691690|O1|Outcome|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730328|NCT01691690|E2|Reported Event|Saline Placebo|"Patients will receive pre-medication with oral midazolam. Participants of this control arm will receive saline to establish a control model for evaluating opioid-sparing effect and pain score reduction compared to the intervention arm.~Sodium Chloride (saline): 0.9% Sodium Chloride Placebo will be infused intraoperatively over 15 minutes to establish a control model while evaluating the pain score differences in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730329|NCT01691690|E1|Reported Event|IV Acetaminophen|"Patients will receive pre-medication with oral midazolam. Participants of this experimental arm of the study will receive Acetaminophen IV to evaluate opioid-sparing effect and pain score reduction.~Acetaminophen (paracetamol): Acetaminophen IV (15 mg/kg) will be infused intraoperatively over 15 minutes to evaluate the opioid-sparing effect and pain score reduction in pediatric patients undergoing tonsillectomy or adenotonsillectomy procedures.~Morphine (hydromorphone): Morphine (0.1 mg/kg) will be added to manage pain prior to intubation."
730330|NCT01691560|B5|Baseline|Total|Total of all reporting groups
730331|NCT01691560|B4|Baseline|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730332|NCT01691560|B3|Baseline|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730333|NCT01691560|B2|Baseline|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730334|NCT01691560|B1|Baseline|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730335|NCT01691560|P4|Participant Flow|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730336|NCT01691560|P3|Participant Flow|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730337|NCT01691560|P2|Participant Flow|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730338|NCT01691560|P1|Participant Flow|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 parts per million (ppm) fluoride as sodium monofluorophosphate
730339|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730340|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730341|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730345|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730346|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730347|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730348|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730349|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730350|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730351|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730352|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730353|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730354|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730355|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730356|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730357|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730358|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730359|NCT01691560|O4|Outcome|0% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730360|NCT01691560|O3|Outcome|Sodium Fluoride|Dentifrice containing 1100 ppm fluoride as sodium fluoride
730361|NCT01691560|O2|Outcome|Sodium Monofluorophosphate|Dentifrice containing 1000 ppm fluoride as sodium monofluorophosphate
730362|NCT01691560|O1|Outcome|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730366|NCT01691560|E1|Reported Event|5% Calcium Sodium Phosphosilicate/ Sodium Monofluorophosphate|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500 ppm fluoride as sodium monofluorophosphate
730367|NCT01691534|B8|Baseline|Total|Total of all reporting groups
730368|NCT01691534|B7|Baseline|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730369|NCT01691534|B6|Baseline|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
730370|NCT01691534|B5|Baseline|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
730371|NCT01691534|B4|Baseline|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730372|NCT01691534|B3|Baseline|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730373|NCT01691534|B2|Baseline|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730374|NCT01691534|B1|Baseline|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730375|NCT01691534|P7|Participant Flow|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730376|NCT01691534|P6|Participant Flow|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
730377|NCT01691534|P5|Participant Flow|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
730378|NCT01691534|P4|Participant Flow|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730379|NCT01691534|P3|Participant Flow|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730380|NCT01691534|P2|Participant Flow|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730381|NCT01691534|P1|Participant Flow|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730382|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730383|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
730384|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
730385|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730386|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730387|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730529|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730388|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730389|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730390|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
730391|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
730392|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730393|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730394|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730395|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730396|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730397|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-1414
730398|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
730399|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730400|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730401|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730402|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730403|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730406|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730407|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730408|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730409|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730410|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730411|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
730412|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
730413|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730414|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730415|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730416|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730417|NCT01691534|O7|Outcome|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730418|NCT01691534|O6|Outcome|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
730419|NCT01691534|O5|Outcome|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
730420|NCT01691534|O4|Outcome|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730421|NCT01691534|O3|Outcome|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730422|NCT01691534|O2|Outcome|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730423|NCT01691534|O1|Outcome|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730424|NCT01691534|E7|Reported Event|Rifafour|Rifafour on Days 1 to 14, dosed by weight
730425|NCT01691534|E6|Reported Event|Clofazimine (C)|clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14
730426|NCT01691534|E5|Reported Event|Pyrazinamide (Z)|pyrazinamide (Z): 1500 mg on Days 1 to 14
731059|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
730427|NCT01691534|E4|Reported Event|TMC207, Pyrazinamide and Clofazimine (J-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730428|NCT01691534|E3|Reported Event|TMC207, PA-824 and Clofazimine (J-PA-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730429|NCT01691534|E2|Reported Event|TMC207, PA-824 and Pyrazinamide (J-PA-Z)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14"
730430|NCT01691534|E1|Reported Event|TMC207, PA-824, Pyrazinamide and Clofazimine (J-PA-Z-C)|"TMC207 (J): 400 mg on Day 1; 300 mg on Day 2; and 200 mg on Days 3 to 14~PA-824 (PA): 200 mg on Days 1 to 14~pyrazinamide (Z): 1500 mg on Days 1 to 14~clofazimine (C): 300 mg on Days 1 to 3 and 100 mg on Days 4-14"
730431|NCT01691521|B4|Baseline|Total|Total of all reporting groups
730432|NCT01691521|B3|Baseline|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730433|NCT01691521|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730434|NCT01691521|B1|Baseline|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730435|NCT01691521|P3|Participant Flow|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730502|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
730503|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730436|NCT01691521|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730437|NCT01691521|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) plus placebo subcutaneously (SC) every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730438|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
730439|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730440|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730441|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
730442|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730443|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730444|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
730530|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
730445|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730446|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730447|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
730448|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730449|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730450|NCT01691521|O3|Outcome|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730451|NCT01691521|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730452|NCT01691521|O1|Outcome|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730453|NCT01691521|E3|Reported Event|Mepolizumab 100 mg SC|Participants received placebo IV plus mepolizumab 100 mg SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study
730454|NCT01691521|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730455|NCT01691521|E1|Reported Event|Placebo|Participants received placebo IV plus placebo SC every 4 weeks (for a total of 8 doses), with the last dose at Week 28. The SC dose and the IV dose were administered into separate arms. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730456|NCT01691508|B3|Baseline|Total|Total of all reporting groups
730457|NCT01691508|B2|Baseline|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730458|NCT01691508|B1|Baseline|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730459|NCT01691508|P2|Participant Flow|Mepolizumab 100mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730460|NCT01691508|P1|Participant Flow|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730461|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730462|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730463|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730464|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730465|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730466|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730467|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730468|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730469|NCT01691508|O2|Outcome|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730470|NCT01691508|O1|Outcome|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730471|NCT01691508|E2|Reported Event|Mepolizumab 100 mg SC|Participants received mepolizumab 100 mg SC every 4 weeks (for a total of 6 doses), with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730472|NCT01691508|E1|Reported Event|Placebo|Participants received placebo subcutaneously (SC) every 4 weeks (for a total of 6 doses),with the last dose at Week 20. A topical anaesthetic was permitted at the injection site to minimize discomfort, as needed. Rescue personnel and rescue medications (salbutamol/albuterol) /equipment were available throughout the study.
730504|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
730473|NCT01691482|B1|Baseline|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
730474|NCT01691482|P2|Participant Flow|Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2|Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2.
730475|NCT01691482|P1|Participant Flow|A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2|Participants received albuterol (4 puffs; 90 micrograms [µg] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2).
730476|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
730477|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
730478|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
730479|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
730480|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
730481|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
730482|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
730483|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
730484|NCT01691482|O2|Outcome|Ipratropium Follwed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
730485|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
730486|NCT01691482|O1|Outcome|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
730487|NCT01691482|O2|Outcome|Ipratropium Followed by Albuterol/Salbutamol|All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2
730488|NCT01691482|O1|Outcome|Albuterol/Salbutamol Followed by Ipratropium|All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2.
730489|NCT01691482|E1|Reported Event|All Randomized Participants|All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2
730490|NCT01691339|B5|Baseline|Total|Total of all reporting groups
730491|NCT01691339|B4|Baseline|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730492|NCT01691339|B3|Baseline|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
730493|NCT01691339|B2|Baseline|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730494|NCT01691339|B1|Baseline|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
730495|NCT01691339|P4|Participant Flow|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730496|NCT01691339|P3|Participant Flow|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
730497|NCT01691339|P2|Participant Flow|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730498|NCT01691339|P1|Participant Flow|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
730499|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730505|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730506|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
730507|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730508|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
730509|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730510|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
730511|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730512|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
730513|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730514|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
730515|NCT01691339|O4|Outcome|Fluzone® High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730516|NCT01691339|O3|Outcome|Fluzone® Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
730517|NCT01691339|O2|Outcome|Fluzone® Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730518|NCT01691339|O1|Outcome|Fluzone® Vaccine (Group 1)|Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly
730519|NCT01691339|E4|Reported Event|Fluzone High-Dose Vaccine (Group 4)|Adults ≥ 65 years of age received one dose of Fluzone High-Dose vaccine intramuscularly
730520|NCT01691339|E3|Reported Event|Fluzone Vaccine (Group 3)|Adults ≥ 65 years of age received one dose of Fluzone vaccine intramuscularly
730521|NCT01691339|E2|Reported Event|Fluzone Intradermal Vaccine (Group 2)|Adults 18 to < 65 years of age received one dose of Fluzone Intradermal vaccine intradermally
730522|NCT01691339|E1|Reported Event|Fluzone Vaccine (Group 1)|'Adults 18 to < 65 years of age received one dose of Fluzone vaccine intramuscularly'
730523|NCT01691326|B3|Baseline|Total|Total of all reporting groups
730524|NCT01691326|B2|Baseline|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
730525|NCT01691326|B1|Baseline|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730526|NCT01691326|P2|Participant Flow|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses 0.5 mL of Fluzone vaccine
730527|NCT01691326|P1|Participant Flow|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730528|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
730532|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
730533|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730534|NCT01691326|O2|Outcome|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
730535|NCT01691326|O1|Outcome|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730536|NCT01691326|O2|Outcome|Age 3 to < 9 Years Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
730537|NCT01691326|O1|Outcome|Age 6 to < 36 Months Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730538|NCT01691326|E2|Reported Event|3 to < 9 Years Age Group|Participants 3 years to < 9 years of age that received one or two doses of 0.5 mL of Fluzone vaccine
730539|NCT01691326|E1|Reported Event|6 to < 36 Months Age Group|Participants 6 months to < 36 months of age that received one or two doses of 0.25 mL of Fluzone vaccine
730540|NCT01691313|B5|Baseline|Total|Total of all reporting groups
730541|NCT01691313|B4|Baseline|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
730542|NCT01691313|B3|Baseline|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
730543|NCT01691313|B2|Baseline|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
730544|NCT01691313|B1|Baseline|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
730545|NCT01691313|P4|Participant Flow|Vanoxerine 400mg|vanoxerine 400 mg (4x100mg oral capsules) single oral dose
730546|NCT01691313|P3|Participant Flow|Vanoxerine 300mg|vanoxerine 300 mg (3x 100 mg oral capsules) single oral dose
730547|NCT01691313|P2|Participant Flow|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
730548|NCT01691313|P1|Participant Flow|Vanoxerine 200mg|"vanoxerine 200 mg (2x 100mg oral capsules)~Vanoxerine: single oral dose"
730549|NCT01691313|O4|Outcome|Vanoxerine 400mg|"vanoxerine oral capsule, 400mg~Vanoxerine: single oral dose"
730550|NCT01691313|O3|Outcome|Vanoxerine 300mg|"vanoxerine oral capsule, 300mg~Vanoxerine: single oral dose"
730551|NCT01691313|O2|Outcome|Vanoxerine 200mg|"vanoxerine oral capsule, 200mg~Vanoxerine: single oral dose"
730552|NCT01691313|O1|Outcome|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
730560|NCT01691313|E1|Reported Event|Placebo|"placebo to match vanoxerine oral capsule~Placebo: single oral dose"
730561|NCT01691248|B3|Baseline|Total|Total of all reporting groups
730562|NCT01691248|B2|Baseline|Placebo|Placebo tablet once daily for no longer than 40 days
730563|NCT01691248|B1|Baseline|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
730564|NCT01691248|P2|Participant Flow|Placebo|Placebo tablet once daily for no longer than 40 days
730565|NCT01691248|P1|Participant Flow|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
730566|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
730567|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
730568|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
730569|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
730570|NCT01691248|O2|Outcome|Placebo|Placebo tablet once daily for no longer than 40 days
730571|NCT01691248|O1|Outcome|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
730572|NCT01691248|E2|Reported Event|Placebo|Placebo tablet once daily for no longer than 40 days
730573|NCT01691248|E1|Reported Event|Fidaxomicin|200 mg Fidaxomicin tablet once daily for no longer than 40 days
730574|NCT01691092|B1|Baseline|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
730575|NCT01691092|P1|Participant Flow|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
730576|NCT01691092|O1|Outcome|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
730577|NCT01691092|E1|Reported Event|Ketamine|"All subjects will receive ketamine~Ketamine: All subjects will receive ketamine to induce glutamate release in the brain"
730578|NCT01691014|B5|Baseline|Total|Total of all reporting groups
730579|NCT01691014|B4|Baseline|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730580|NCT01691014|B3|Baseline|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730581|NCT01691014|B2|Baseline|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730582|NCT01691014|B1|Baseline|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730583|NCT01691014|P4|Participant Flow|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730584|NCT01691014|P3|Participant Flow|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730585|NCT01691014|P2|Participant Flow|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730586|NCT01691014|P1|Participant Flow|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730587|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730588|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730589|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730590|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730591|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730592|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730593|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730594|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730595|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730596|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730597|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730598|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730599|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730600|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730601|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730602|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730822|NCT01690000|P1|Participant Flow|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
730603|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730604|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730605|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730606|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730607|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730608|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730609|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730610|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730611|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730612|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730613|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730614|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730615|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730616|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730617|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730618|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730619|NCT01691014|O4|Outcome|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730620|NCT01691014|O3|Outcome|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730621|NCT01691014|O2|Outcome|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730622|NCT01691014|O1|Outcome|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730623|NCT01691014|E4|Reported Event|Infliximab|Participants with RA who received infliximab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730624|NCT01691014|E3|Reported Event|Certolizumab|Participants with RA who received certolizumab as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730625|NCT01691014|E2|Reported Event|Etanercept|Participants with RA who received etanercept as per SmPC during daily clinical practice, were observed prospectively for 12 months.
730626|NCT01691014|E1|Reported Event|Adalimumab|Participants with rheumatoid arthritis (RA) who received adalimumab as per summary of product characteristics (SmPC) during daily clinical practice, were observed prospectively for 12 months.
730627|NCT01690923|B1|Baseline|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
730628|NCT01690923|P2|Participant Flow|Pillows Mask First, Then Nasal Mask|"Sequence 2: Pillows mask first, then Nasal mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
730629|NCT01690923|P1|Participant Flow|Nasal Mask First, Then Pillows Mask|"Sequence 1: Nasal mask first, then Pillows mask~[Nasal mask : Nasal mask (Mirage Activa, Micro, FX) Pillows mask : Nasal pillows mask (Swift FX)]"
730630|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
730631|NCT01690923|O1|Outcome|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
730632|NCT01690923|E1|Reported Event|Current CPAP Users|"Nasal mask; Pillows mask~Nasal mask : Nasal mask (Mirage Activa, Micro, FX)~Pillows mask : Nasal pillows mask (Swift FX)"
730633|NCT01690663|B5|Baseline|Total|Total of all reporting groups
730634|NCT01690663|B4|Baseline|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
730635|NCT01690663|B3|Baseline|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730636|NCT01690663|B2|Baseline|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730637|NCT01690663|B1|Baseline|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
730638|NCT01690663|P4|Participant Flow|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
730639|NCT01690663|P3|Participant Flow|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730640|NCT01690663|P2|Participant Flow|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730641|NCT01690663|P1|Participant Flow|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
730642|NCT01690663|O4|Outcome|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
730643|NCT01690663|O3|Outcome|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730644|NCT01690663|O2|Outcome|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730645|NCT01690663|O1|Outcome|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
730646|NCT01690663|O4|Outcome|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
730647|NCT01690663|O3|Outcome|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730648|NCT01690663|O2|Outcome|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730649|NCT01690663|O1|Outcome|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
730650|NCT01690663|E4|Reported Event|Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml|"Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml~Bupivacaine 0.25%~Dexamethasone"
730651|NCT01690663|E3|Reported Event|Bupivacaine 0.25% Mixed With 2mg Dexamethasone|"Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730652|NCT01690663|E2|Reported Event|Bupivacaine 0.25% With 1mg Dexamethasone (1ml)|"Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)~Bupivacaine 0.25%~Dexamethasone"
730653|NCT01690663|E1|Reported Event|Bupivacaine 0.25% Mixed With 1ml Normal Saline|"Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)~Bupivacaine 0.25%~normal saline: placebo"
730654|NCT01690546|B1|Baseline|BUP/VLNXT to VIVITROL|
730655|NCT01690546|P1|Participant Flow|BUP/VLNXT to VIVITROL|
730656|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730657|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730658|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730659|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730660|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730661|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730662|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730663|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730664|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730665|NCT01690546|O1|Outcome|BUP/VLNXT to VIVITROL|
730666|NCT01690546|E1|Reported Event|BUP/VLNXT to VIVITROL|
730667|NCT01690299|B4|Baseline|Total|Total of all reporting groups
730668|NCT01690299|B3|Baseline|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730669|NCT01690299|B2|Baseline|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730807|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730670|NCT01690299|B1|Baseline|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730671|NCT01690299|P6|Participant Flow|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants discontinued etanercept and were switched to apremilast 30mg PO BID through week 104.
730672|NCT01690299|P5|Participant Flow|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID only through week 104.
730673|NCT01690299|P4|Participant Flow|Placebo/Apremilast|Participants received identically matching placebo tablets by PO, BID and SC saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg apremilast PO BID and remained on this dose through week 104.
730674|NCT01690299|P3|Participant Flow|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730675|NCT01690299|P2|Participant Flow|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730676|NCT01690299|P1|Participant Flow|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730677|NCT01690299|O3|Outcome|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
730678|NCT01690299|O2|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
730679|NCT01690299|O1|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
730680|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730681|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730682|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730683|NCT01690299|O3|Outcome|Etanercept/Apremilast|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
730684|NCT01690299|O2|Outcome|Apremilast/Apremilast|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
730685|NCT01690299|O1|Outcome|Placebo/Apremilast|Participants received identically matching placebo tablets PO BID and SC saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
730686|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730687|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730688|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730689|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730690|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730691|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730692|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730693|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730694|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730695|NCT01690299|O3|Outcome|Etanercept 50mg Plus Placebo Tablet|Etanercept 50 mg by SC injection QW plus placebo tablets PO, BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730696|NCT01690299|O2|Outcome|Apremilast 30mg Plus Placebo Injection|Apremilast 30 mg PO BID plus 2-1ml placebo SC saline injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730697|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730698|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730699|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730700|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730701|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablets|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730702|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730703|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730704|NCT01690299|O3|Outcome|Etanercept Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
730705|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730706|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730707|NCT01690299|O2|Outcome|Etanercept 50mg Plus Placebo Tablet|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase.
730708|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730709|NCT01690299|O2|Outcome|Apremilast Plus Placebo Injection|Participants received apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730710|NCT01690299|O1|Outcome|Placebo|Participants received placebo tablets PO BID and 2-1 ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730711|NCT01690299|E6|Reported Event|Etanercept/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to apremilast 30mg PO BID through week 104.
730712|NCT01690299|E5|Reported Event|APR/APR 30 mg (Apremilast Exposure Phase) Weeks 0-104|Participants received apremilast 30 mg PO BID plus saline (placebo) injections (1mL x 2 injections SC) QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants continued on apremilast 30mg PO BID through week 104.
730713|NCT01690299|E4|Reported Event|Placebo/APR 30mg (Apremilast Exposure Phase) Weeks 16-104|Participants received identically matching placebo tablets by mouth (PO), twice a day (BID) and subcutaneous (SC) saline (placebo) injections (1mL x 2 injections SC) weekly (QW) during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase; at week 16, participants were switched to 30 mg Apremilast PO BID and remained on this dose through week 104.
730714|NCT01690299|E3|Reported Event|Etanercept Plus Placebo Tablets (Week 0-16)|Participants received etanercept 50 mg by SC injection QW plus placebo tablets PO BID during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730715|NCT01690299|E2|Reported Event|Apremilast Plus Placebo Injection (Week 0-16)|Participants received Apremilast 30 mg PO BID plus 2-1ml SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730716|NCT01690299|E1|Reported Event|Placebo (Week 0-16)|Participants received placebo tablets PO BID and 2-1 milliliter (ml) SC saline (placebo) injections QW during the 16-week randomized, double-blind, double-dummy, placebo-controlled phase
730717|NCT01690273|B4|Baseline|Total|Total of all reporting groups
730718|NCT01690273|B3|Baseline|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
730719|NCT01690273|B2|Baseline|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
730720|NCT01690273|B1|Baseline|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
730721|NCT01690273|P3|Participant Flow|Mobility and Elastic Resistance Exercise in AS|"mobility, plus elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730722|NCT01690273|P2|Participant Flow|Mobility in Ankylosing Spondylitis|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730723|NCT01690273|P1|Participant Flow|Ankylosing Spondylitis Control|control group, no intervention in ankylosing spondylitis patients
730724|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730725|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730726|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730727|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730728|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730729|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730730|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730731|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730732|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730733|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730734|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730735|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730736|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730737|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730738|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730739|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730740|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730741|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730742|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730743|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730744|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730745|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730746|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730747|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730787|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730748|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730749|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730750|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730751|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730752|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730753|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730754|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730755|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730756|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730757|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730758|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730759|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group AS patients with no exercise
730760|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
730761|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week for sixteen weeks."
730762|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
730763|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730764|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730765|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
730766|NCT01690273|O3|Outcome|Mobility Plus Elastic Resistance Exercise in AS|"mobility and elastic resistance exercises~mobility and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour)"
730767|NCT01690273|O2|Outcome|Mobility in AS|"mobility exercises~mobility exercise: 30 minutes, twice a week"
730768|NCT01690273|O1|Outcome|Ankylosing Spondylitis Control|control group with AS patients and no exercise
730769|NCT01690273|E3|Reported Event|Elastic Resistance Exercise in AS|"stretching and elastic resistance exercises~stretching and elastic resistance exercise: 30 minutes, twice a week each exercises group. (total 1 hour) for sixteen weeks."
730770|NCT01690273|E2|Reported Event|Stretching in AS|"stretching exercises~stretching exercise: 30 minutes, twice a week for sixteen weeks."
730771|NCT01690273|E1|Reported Event|Ankylosing Spondylitis Control|Following a randomization, patients from control group stays during sixteen weeks only with medical treatment.
730772|NCT01690117|B3|Baseline|Total|Total of all reporting groups
730773|NCT01690117|B2|Baseline|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730774|NCT01690117|B1|Baseline|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730775|NCT01690117|P2|Participant Flow|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730776|NCT01690117|P1|Participant Flow|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730777|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730778|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730779|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730780|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730781|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730782|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730783|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730784|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730785|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730786|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730788|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730789|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730790|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730791|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730792|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730793|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730794|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730795|NCT01690117|O2|Outcome|Control Group|The informal caregivers of the control group only receive the standard supply of health care Services.
730796|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730797|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730798|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730799|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730800|NCT01690117|O1|Outcome|Intervention Group|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730801|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730802|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730803|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730804|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730805|NCT01690117|O2|Outcome|Control Group|"usual care~The informal caregivers of the control group only receive the standard supply of health care Services."
730806|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730808|NCT01690117|O1|Outcome|DeREACH-program|"DeREACH-program~DeREACH-program: The intervention program Resources to Enhance Alzheimer`s Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
730809|NCT01690117|E2|Reported Event|Control Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
730810|NCT01690117|E1|Reported Event|Intervention Group|Serious and Other [Not Including Serious] Adverse Events were not monitored/assessed.
730811|NCT01690052|B1|Baseline|All Participants|"Two interventions were assembled:~For the first intervention, the SEQUENCE was cevimeline (30mg three times a day) for 4 weeks and then Pilocarpine (5 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week.~For the second intervention, the SEQUENCE was Pilocarpine (5mg three times a day) or 4 weeks and then Cevimeline (30 mg three times a day) for 4 weeks, after the first sequence, the participants had a washout period for one week."
730812|NCT01690052|P2|Participant Flow|Pilocarpine First, Then Cevimeline|Pilocarpine First then Cevimeline: Pilocarpine (5 mg three times a day) for 4 weeks (first intervention period) and then Cevimeline (30mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
730813|NCT01690052|P1|Participant Flow|Cevimeline First, Then Pilocarpine|Cevimeline First then Pilocarpine: Cevimeline (30mg three times a day) for 4 weeks (First intervention period) and then pilocarpine (5 mg three times a day) for 4 weeks (second intervention period). In between first and second intervention period, participants had a washout period for one week.
730814|NCT01690052|O2|Outcome|Pilocarpine|Pilocarpine 5 mg administered three times a day in either first intervention period or second intervention period
730815|NCT01690052|O1|Outcome|Cevimeline|Cevimeline 30mg administered three times a day in first intervention period or second intervention period for 4 weeks.
730816|NCT01690052|E2|Reported Event|Pilocarpine Then Cevimeline (Intervention 2)|Pilocarpine then cevimeline One week washout period
730817|NCT01690052|E1|Reported Event|Cevimeline Then Pilocarpine (Intervention 1)|Cevimeline then pilocarpine One week washout period
730818|NCT01690000|B3|Baseline|Total|Total of all reporting groups
730819|NCT01690000|B2|Baseline|Placebo|Identical placebo given nightly for 12 months
730820|NCT01690000|B1|Baseline|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
730823|NCT01690000|O2|Outcome|Placebo|"Identical placebo given nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
730824|NCT01690000|O1|Outcome|Melatonin1+3|"1+3 mg melatonin nightly~Melatonin: 1 or 3 mg of melatonin PO each night for 12 months"
730825|NCT01690000|E2|Reported Event|Placebo|Identical placebo given nightly for 12 months
730826|NCT01690000|E1|Reported Event|Melatonin1+3|Melatonin: 1 or 3 mg of melatonin PO each night for 12 months
730827|NCT01689857|B3|Baseline|Total|Total of all reporting groups
730828|NCT01689857|B2|Baseline|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
730829|NCT01689857|B1|Baseline|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
730830|NCT01689857|P2|Participant Flow|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
730831|NCT01689857|P1|Participant Flow|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
730832|NCT01689857|O2|Outcome|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
730833|NCT01689857|O1|Outcome|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
730834|NCT01689857|E2|Reported Event|Scarclinic™ Normal|Scarclinic™ Normal applied on the surgical scar for 12weeks
730835|NCT01689857|E1|Reported Event|Scarclinic™ Thin|Scarclinic™ Thin applied on the surgical scar for 12weeks
730836|NCT01689649|B1|Baseline|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730837|NCT01689649|P1|Participant Flow|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730838|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730839|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730840|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730841|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730842|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730843|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730844|NCT01689649|O1|Outcome|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730845|NCT01689649|E1|Reported Event|Topiramate|The participants will receive an initial dose of 0.5mg/kg per oral (PO) in the evening, followed by increasing dosage of 0.5 mg/kg/day every week during 6 weeks until the target dose of 3 mg/kg/day being achieved. Subsequent dose is titrated by increasing 0.5 mg/kg/day every week to reach optimal dose according to efficacy and tolerability, but not exceeding total dose of 9 mg/kg/day.
730846|NCT01689532|B3|Baseline|Total|Total of all reporting groups
730847|NCT01689532|B2|Baseline|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730848|NCT01689532|B1|Baseline|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730849|NCT01689532|P2|Participant Flow|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730850|NCT01689532|P1|Participant Flow|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730851|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730852|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730853|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730854|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730855|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730856|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730857|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730858|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730859|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730860|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730861|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730862|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730863|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730864|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730865|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730866|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730867|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730868|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730869|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730870|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730871|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730872|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730873|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730937|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
730874|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730875|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730876|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730877|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730878|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730879|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730880|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730881|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730882|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730883|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730884|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730885|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730984|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730886|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730887|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730888|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730889|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730890|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730891|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730892|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730893|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730894|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730895|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730896|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730897|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730898|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730899|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730900|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730901|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730902|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730903|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730904|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730905|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730938|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
730906|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730907|NCT01689532|O2|Outcome|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730908|NCT01689532|O1|Outcome|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730909|NCT01689532|E2|Reported Event|Sirukumab 100 mg|Participants received Sirukumab 100 mg SC at Weeks 0, 2, and every 2 weeks (q2w) through Week 52.
730910|NCT01689532|E1|Reported Event|Sirukumab 50 Milligram (mg)|Participants received sirukumab 50 milligram (mg) subcutaneous (SC) at Weeks 0, 4, and every 4 weeks (q4w) through Week 52. Between sirukumab injections, participants received placebo SC at Weeks 2, 6, and q4w through Week 52.
730911|NCT01689519|B3|Baseline|Total|Total of all reporting groups
730912|NCT01689519|B2|Baseline|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730913|NCT01689519|B1|Baseline|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730914|NCT01689519|P2|Participant Flow|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730915|NCT01689519|P1|Participant Flow|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730916|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730917|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730918|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730919|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730920|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730921|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730922|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730923|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730924|NCT01689519|O2|Outcome|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730925|NCT01689519|O1|Outcome|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730926|NCT01689519|E2|Reported Event|Cobimetinib + Vemurafenib|Participants received cobimetinib 60 mg orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730927|NCT01689519|E1|Reported Event|Placebo + Vemurafenib|Participants received placebo orally once daily on Days 1-21 of each 28 day cycle plus vemurafenib 960 mg orally twice a day on Days 1-28 of each 28 day cycle until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurs earliest.
730928|NCT01689441|B3|Baseline|Total|Total of all reporting groups
730929|NCT01689441|B2|Baseline|Placebo|"Normal saline 2cc IV x 1~Placebo"
730930|NCT01689441|B1|Baseline|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
730931|NCT01689441|P2|Participant Flow|Placebo|"Normal saline 2cc IV x 1~Placebo"
730932|NCT01689441|P1|Participant Flow|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
730933|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
730934|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
730935|NCT01689441|O2|Outcome|Placebo|"Normal saline 2cc IV x 1~Placebo"
730936|NCT01689441|O1|Outcome|Calcitriol|"Calcitriol 2mcg IV x 1~Calcitriol"
730941|NCT01689363|B1|Baseline|Total Study Population|Subjects received four intradermal injections of study drug (two injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL), one injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL), one injection of 0.02 mL saline) in a random order at four locations on the subjects’ forearms.
730942|NCT01689363|P8|Participant Flow|P, H, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
730943|NCT01689363|P7|Participant Flow|P, H, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
730944|NCT01689363|P6|Participant Flow|N, H, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
730945|NCT01689363|P5|Participant Flow|N, H, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL saline at the upper-left forearm; 2) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
730985|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730986|NCT01689363|O1|Outcome|Intent-to-Treat Population (ITT)|Subjects who have been randomized
730946|NCT01689363|P4|Participant Flow|H, P, N, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL saline at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
730947|NCT01689363|P3|Participant Flow|H, P, H, N|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL saline at the lower-right forearm
730948|NCT01689363|P2|Participant Flow|H, N, P, H|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the upper-right forearm; 4) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the lower-right forearm
730949|NCT01689363|P1|Participant Flow|H, N, H, P|Subjects received four intradermal injections where study drug was injected to sites on the subject’s forearms in the following order: 1) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-left forearm; 2) 0.02 mL saline at the lower-left forearm; 3) 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at the upper-right forearm; 4) 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at the lower-right forearm
730950|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730951|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730952|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730953|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730954|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730955|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730956|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730957|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730958|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730959|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730960|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730961|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730962|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730963|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730964|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730965|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730966|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730967|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
731060|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
730968|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730969|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730970|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730971|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730972|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730973|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730974|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730975|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730976|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730977|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730978|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730979|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730980|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730981|NCT01689363|O2|Outcome|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730982|NCT01689363|O1|Outcome|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730983|NCT01689363|O3|Outcome|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730987|NCT01689363|O1|Outcome|Per-Protocol Population (PPP)|Subjects who: a) have received the right treatment; b) have a negative reaction for the negative control; c) have a positive reaction for the positive control; and d) have the same reaction for both Amphadase® treatments
730988|NCT01689363|E4|Reported Event|All Arms|Cannot identify which study drug may be associated with the ADE because the subject received all four injections almost at the same time
730989|NCT01689363|E3|Reported Event|Arm P|Subjects received an intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one site on their forearms
730990|NCT01689363|E2|Reported Event|Arm N|Subjects received an intradermal injection of 0.02 mL saline at one site on their forearms
730991|NCT01689363|E1|Reported Event|Arm H|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two sites on their forearms
730992|NCT01689350|B3|Baseline|Total|Total of all reporting groups
730993|NCT01689350|B2|Baseline|Experimental Group|47 cases in experimental group were genotyped as extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM）with initial dose of CPA as 0.2g, 0.4g and 0.6g per week by injection, respectively.
730994|NCT01689350|B1|Baseline|Control Group|45 cases in control group received traditional therapy that the initial dose of cyclophosphamide (CPA) was 0.2-0.6g/week injection according to clinical experience.
730995|NCT01689350|P2|Participant Flow|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
730996|NCT01689350|P1|Participant Flow|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
730997|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
730998|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
730999|NCT01689350|O2|Outcome|Control Group|CPA medication was according to the traditional experiences.
731000|NCT01689350|O1|Outcome|Experimental Group|CPA medication was according to the genotypes of SLE patients.
731001|NCT01689350|E2|Reported Event|Control Group|Cyclophosphamide (CPA) medication was according to the traditional experiences.
731002|NCT01689350|E1|Reported Event|Experimental Group|Cyclophosphamide (CPA) medication was according to the genotypes of SLE patients.
731003|NCT01689337|B1|Baseline|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
731004|NCT01689337|P1|Participant Flow|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
731005|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731006|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731007|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731008|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731009|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731010|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731061|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731011|NCT01689337|O1|Outcome|AS902330, 100 mcg|AS902330 was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731012|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
731013|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731014|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
731015|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731016|NCT01689337|O1|Outcome|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
731017|NCT01689337|E1|Reported Event|Sprifermin (AS902330), 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after microfracture (MFx) surgery.
731018|NCT01689324|B1|Baseline|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731019|NCT01689324|P1|Participant Flow|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731020|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731021|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731022|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731023|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731024|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731025|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731026|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731027|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731028|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731029|NCT01689324|O1|Outcome|Study Group|Participants received a single booster dose of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis vaccine (Tdap vaccine; ADACEL®) on Day 0.
731030|NCT01689324|E1|Reported Event|Study Group|Participants received a single booster dose of Tdap vaccine on Day 0.
731031|NCT01689207|B12|Baseline|Total|Total of all reporting groups
731032|NCT01689207|B11|Baseline|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731033|NCT01689207|B10|Baseline|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731034|NCT01689207|B9|Baseline|Part C: Placebo|Placebo
731035|NCT01689207|B8|Baseline|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731036|NCT01689207|B7|Baseline|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731037|NCT01689207|B6|Baseline|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731038|NCT01689207|B5|Baseline|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731039|NCT01689207|B4|Baseline|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731040|NCT01689207|B3|Baseline|Part B: Placebo|Placebo
731041|NCT01689207|B2|Baseline|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731042|NCT01689207|B1|Baseline|Part A: Placebo|Placebo
731043|NCT01689207|P11|Participant Flow|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731044|NCT01689207|P10|Participant Flow|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731045|NCT01689207|P9|Participant Flow|Part C: Placebo|Placebo
731046|NCT01689207|P8|Participant Flow|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731047|NCT01689207|P7|Participant Flow|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731048|NCT01689207|P6|Participant Flow|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731049|NCT01689207|P5|Participant Flow|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731050|NCT01689207|P4|Participant Flow|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731051|NCT01689207|P3|Participant Flow|Part B: Placebo|Placebo
731052|NCT01689207|P2|Participant Flow|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731053|NCT01689207|P1|Participant Flow|Part A: Placebo|Placebo
731054|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731055|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731056|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
731057|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731058|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731063|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731064|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
731065|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731066|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731067|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
731068|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731069|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731070|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731071|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731072|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731073|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
731074|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731075|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
731076|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731077|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731078|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
731079|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731080|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731081|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731082|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731083|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731084|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
731085|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731087|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731088|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731089|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
731090|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731091|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731092|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731093|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731094|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731095|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
731096|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731097|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
731098|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731099|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731100|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
731101|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731102|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731103|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731104|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731105|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731106|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
731107|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731108|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
731109|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731110|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731111|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
731112|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731113|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731114|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731115|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731116|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731117|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
731118|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731119|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
731120|NCT01689207|O14|Outcome|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
731121|NCT01689207|O13|Outcome|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
731122|NCT01689207|O12|Outcome|Part A: Aztreonam (ATM) 2000mg|Crossover period ATm 2000mg
731123|NCT01689207|O11|Outcome|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731124|NCT01689207|O10|Outcome|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731125|NCT01689207|O9|Outcome|Part C: Placebo|Placebo
731126|NCT01689207|O8|Outcome|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731127|NCT01689207|O7|Outcome|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731128|NCT01689207|O6|Outcome|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731129|NCT01689207|O5|Outcome|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731130|NCT01689207|O4|Outcome|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731131|NCT01689207|O3|Outcome|Part B: Placebo|Placebo
731132|NCT01689207|O2|Outcome|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731133|NCT01689207|O1|Outcome|Part A: Placebo|Placebo
731450|NCT01687790|P1|Participant Flow|Molecular Breast Imaging|molecular breast imaging (Discovery)
731134|NCT01689207|E14|Reported Event|Part A: ATM 2000mg + AVI 600mg|Crossover period ATM 2000mg + AVI 600mg
731135|NCT01689207|E13|Reported Event|Part A: Avibactam (AVI) 600mg|Crossover period AVI 600mg
731136|NCT01689207|E12|Reported Event|Part A: Aztreonam (ATM) 2000mg|Crossover period ATM 2000mg
731137|NCT01689207|E11|Reported Event|Part C: Cohort 2 Drug|Aged >65: ATM (500mg followed by 1500mg) + AVI (136.7mg + 410mg)
731138|NCT01689207|E10|Reported Event|Part C: Cohort 1 Drug|Aged 18-45: ATM (500mg followed by 1500mg) + AVI (136.7mg followed by 410mg)
731139|NCT01689207|E9|Reported Event|Part C: Placebo|Placebo
731140|NCT01689207|E8|Reported Event|Part B: Cohort 5 Drug|ATM (1500mg) + AVI (410mg)
731141|NCT01689207|E7|Reported Event|Part B: Cohort 4 Drug|ATM (1500mg) + AVI (450mg)
731142|NCT01689207|E6|Reported Event|Part B: Cohort 3 Drug|ATM (1500mg) + AVI (600mg)
731143|NCT01689207|E5|Reported Event|Part B: Cohort 2 Drug|ATM (2000mg) + AVI (600mg)
731144|NCT01689207|E4|Reported Event|Part B: Cohort 1 Drug|ATM (2000mg) + AVI (375mg)
731145|NCT01689207|E3|Reported Event|Part B: Placebo|Placebo
731146|NCT01689207|E2|Reported Event|Part A: Drug|Aztreonam (ATM) 2000mg, Avibactam (AVI) 600mg, ATM 2000mg +AVI 600mg (crossover)
731147|NCT01689207|E1|Reported Event|Part A: Placebo|Placebo
731148|NCT01689155|B1|Baseline|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
731149|NCT01689155|P1|Participant Flow|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
731150|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
731151|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
731152|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
731153|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
731154|NCT01689155|O2|Outcome|Control Group|There was no separate control group per se. For all analyses, rates of events in a risk window for participants were compared with rates of events in a control window for the same participants.
731155|NCT01689155|O1|Outcome|Menactra Vaccine Recipients|Participants 9 months through 23 months of age receiving Menactra vaccine within the study institution following licensure of the vaccine for this age indication. KPNC databases were used; Menactra vaccine was administered according to routine clinical practice.
731156|NCT01689155|E1|Reported Event|Menactra Vaccine Recipients|Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.
731157|NCT01688921|B3|Baseline|Total|Total of all reporting groups
731158|NCT01688921|B2|Baseline|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731159|NCT01688921|B1|Baseline|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
731160|NCT01688921|P2|Participant Flow|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731161|NCT01688921|P1|Participant Flow|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
731162|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731163|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731164|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731165|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731166|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731167|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731168|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731169|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731170|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731171|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731172|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731173|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731174|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731175|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731176|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731177|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731178|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731179|NCT01688921|O2|Outcome|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731180|NCT01688921|O1|Outcome|PJ STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the PJ STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~PJ STRATIS needle-free injection device"
731181|NCT01688921|E2|Reported Event|Needle-Syringe|"Patients assigned to this arm will receive AFLURIA vaccine administered using a needle and syringe.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~Needle-Syringe"
731182|NCT01688921|E1|Reported Event|STRATIS|"Patients assigned to this arm will receive AFLURIA vaccine administered using the STRATIS needle-free injection device.~AFLURIA vaccine (2012-2013 formulation): Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.~STRATIS needle-free injection device"
731183|NCT01688882|B3|Baseline|Total|Total of all reporting groups
731184|NCT01688882|B2|Baseline|Placebo|Placebo to Match Q2W s.c.
731185|NCT01688882|B1|Baseline|QGE031|QGE031 240 mg Q2W s.c.
731186|NCT01688882|P2|Participant Flow|Placebo|Placebo to Match Q2W s.c.
731187|NCT01688882|P1|Participant Flow|QGE031|QGE031 240 mg Q2W s.c.
731188|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
731189|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
731190|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
731191|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
731192|NCT01688882|O2|Outcome|Placebo|Placebo to Match Q2W s.c.
731193|NCT01688882|O1|Outcome|QGE031|QGE031 240 mg Q2W s.c.
731194|NCT01688882|E6|Reported Event|Follow-up Period: Open Label QGE031|Follow-up Period after completion of Part 1 Open Label QGE031 Q2W s.c.
731195|NCT01688882|E5|Reported Event|Follow-up Period: Placebo|Follow-up Period after completion of Part 1 Placebo to Match Q2W s.c.
731196|NCT01688882|E4|Reported Event|Follow-up Period: QGE031|Follow-up Period after completion of Part 1 QGE031 240 mg Q2W s.c.
731197|NCT01688882|E3|Reported Event|Open Label QGE031|Open Label QGE031 Q2W s.c.
731198|NCT01688882|E2|Reported Event|Placebo|Placebo to Match Q2W s.c.
731199|NCT01688882|E1|Reported Event|QGE031|QGE031 240 mg Q2W s.c
731200|NCT01688830|B22|Baseline|Total|Total of all reporting groups
731201|NCT01688830|B21|Baseline|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731202|NCT01688830|B20|Baseline|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731233|NCT01688830|P10|Participant Flow|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
731203|NCT01688830|B19|Baseline|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731204|NCT01688830|B18|Baseline|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731205|NCT01688830|B17|Baseline|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731206|NCT01688830|B16|Baseline|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731207|NCT01688830|B15|Baseline|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731208|NCT01688830|B14|Baseline|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731209|NCT01688830|B13|Baseline|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
731210|NCT01688830|B12|Baseline|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
731211|NCT01688830|B11|Baseline|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
731212|NCT01688830|B10|Baseline|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
731213|NCT01688830|B9|Baseline|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731214|NCT01688830|B8|Baseline|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
731215|NCT01688830|B7|Baseline|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731216|NCT01688830|B6|Baseline|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
731217|NCT01688830|B5|Baseline|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
731218|NCT01688830|B4|Baseline|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
731219|NCT01688830|B3|Baseline|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
731220|NCT01688830|B2|Baseline|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
731221|NCT01688830|B1|Baseline|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
731222|NCT01688830|P21|Participant Flow|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731223|NCT01688830|P20|Participant Flow|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731224|NCT01688830|P19|Participant Flow|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731225|NCT01688830|P18|Participant Flow|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731226|NCT01688830|P17|Participant Flow|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731227|NCT01688830|P16|Participant Flow|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731228|NCT01688830|P15|Participant Flow|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731229|NCT01688830|P14|Participant Flow|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731230|NCT01688830|P13|Participant Flow|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
731231|NCT01688830|P12|Participant Flow|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
731232|NCT01688830|P11|Participant Flow|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
731234|NCT01688830|P9|Participant Flow|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731235|NCT01688830|P8|Participant Flow|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
731236|NCT01688830|P7|Participant Flow|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731237|NCT01688830|P6|Participant Flow|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
731238|NCT01688830|P5|Participant Flow|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
731239|NCT01688830|P4|Participant Flow|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
731240|NCT01688830|P3|Participant Flow|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
731241|NCT01688830|P2|Participant Flow|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
731242|NCT01688830|P1|Participant Flow|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
731243|NCT01688830|O2|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731244|NCT01688830|O1|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731245|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731246|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731247|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731248|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731249|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731250|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731251|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
731252|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731253|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731254|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731255|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731256|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
731257|NCT01688830|O6|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731258|NCT01688830|O5|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731259|NCT01688830|O4|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731260|NCT01688830|O3|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731261|NCT01688830|O2|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731262|NCT01688830|O1|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731263|NCT01688830|O8|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731264|NCT01688830|O7|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731265|NCT01688830|O6|Outcome|DE (Dose Groups 17: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose group 17
731266|NCT01688830|O5|Outcome|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731267|NCT01688830|O4|Outcome|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731268|NCT01688830|O3|Outcome|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731269|NCT01688830|O2|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731270|NCT01688830|O1|Outcome|DE (Dose Groups 14−16: Day 3)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 in dose groups 14-16
731271|NCT01688830|O21|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731272|NCT01688830|O20|Outcome|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731273|NCT01688830|O19|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731274|NCT01688830|O18|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731275|NCT01688830|O17|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731276|NCT01688830|O16|Outcome|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731277|NCT01688830|O15|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731278|NCT01688830|O14|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731279|NCT01688830|O13|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
731280|NCT01688830|O12|Outcome|Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo~This is administered during Part 1 of the study"
731281|NCT01688830|O11|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
731282|NCT01688830|O10|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
731283|NCT01688830|O9|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731284|NCT01688830|O8|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
731285|NCT01688830|O7|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731380|NCT01688830|E5|Reported Event|600 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum
731286|NCT01688830|O6|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
731287|NCT01688830|O5|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
731288|NCT01688830|O4|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
731289|NCT01688830|O3|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
731290|NCT01688830|O2|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
731291|NCT01688830|O1|Outcome|Placebo 1 h|"One single intravenous long infusion (1 h) of Idarucizumab Placebo~This is administered during Part 1 of the study"
731292|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731293|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731294|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731295|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731506|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731296|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731297|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731298|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
731299|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
731300|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
731301|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731302|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
731303|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731304|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
731305|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
731306|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
731307|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
731308|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
731309|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731310|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731311|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731312|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731313|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731314|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731315|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
731451|NCT01687790|O1|Outcome|Molecular Breast Imaging|molecular breast imaging (Discovery)
731316|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
731317|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
731318|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731319|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
731320|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731321|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
731322|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
731323|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
731324|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
731325|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
731326|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731327|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731507|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
731328|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731329|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731330|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731331|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731332|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
731333|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
731334|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
731335|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731336|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
731337|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731338|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
731339|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
731340|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
731341|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
731342|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
731343|NCT01688830|O17|Outcome|DE+ 5 g + 2.5 g Idarucizumab|"Dose group 17: Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 3 of the study~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731344|NCT01688830|O16|Outcome|DE+ 4 g Idarucizumab 5min|"Dose group 16: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731345|NCT01688830|O15|Outcome|DE+ 2 g Idarucizumab 5min|"Dose group 15: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731381|NCT01688830|E4|Reported Event|200 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum
731382|NCT01688830|E3|Reported Event|60 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum
731346|NCT01688830|O14|Outcome|DE+ 1 g Idarucizumab 5min|"Dose group 14: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~This is administered during Part 2 of the study.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731347|NCT01688830|O13|Outcome|4 g Idarucizumab 5min|"Dose group 13: One single intravenous short infusion (5 min) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731348|NCT01688830|O12|Outcome|2 g Idarucizumab 5min|"Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731349|NCT01688830|O11|Outcome|1 g Idarucizumab 5min|"Dose group 11: One single intravenous short infusion (5 min) of 1 g Idarucizumab verum~This is administered during Part 1 of the study"
731350|NCT01688830|O10|Outcome|8 g Idarucizumab 1h|"Dose group 10: One single intravenous long infusion (1 h) of 8 g Idarucizumab verum~This is administered during Part 1 of the study"
731351|NCT01688830|O9|Outcome|6 g Idarucizumab 1h|"Dose group 9: One single intravenous long infusion (1 h) of 6 g Idarucizumab verum~This is administered during Part 1 of the study"
731352|NCT01688830|O8|Outcome|4 g Idarucizumab 1h|"Dose group 8: One single intravenous long infusion (1 h) of 4 g Idarucizumab verum~This is administered during Part 1 of the study"
731353|NCT01688830|O7|Outcome|3 g Idarucizumab 1h|"Dose group 7: One single intravenous long infusion (1 h) of 3 g Idarucizumab verum~This is administered during Part 1 of the study"
731354|NCT01688830|O6|Outcome|2 g Idarucizumab 1h|"Dose group 6: One single intravenous long infusion (1 h) of 2 g Idarucizumab verum~This is administered during Part 1 of the study"
731355|NCT01688830|O5|Outcome|1.2 g Idarucizumab 1h|"Dose group 5: One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum~This is administered during Part 1 of the study"
731356|NCT01688830|O4|Outcome|600 mg Idarucizumab 1h|"Dose group 4: One single intravenous long infusion (1 h) of 600 mg Idarucizumab verum~This is administered during Part 1 of the study"
731357|NCT01688830|O3|Outcome|200 mg Idarucizumab 1h|"Dose group 3: One single intravenous long infusion (1 h) of 200 mg Idarucizumab verum~This is administered during Part 1 of the study"
731358|NCT01688830|O2|Outcome|60 mg Idarucizumab 1h|"Dose group 2: One single intravenous long infusion (1 h) of 60 mg Idarucizumab verum~This is administered during Part 1 of the study"
731359|NCT01688830|O1|Outcome|20 mg Idarucizumab 1h|"Dose group 1: One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum~This is administered during Part 1 of the study"
731508|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731360|NCT01688830|E25|Reported Event|DE+ 5 g + 2.5 g Idarucizumab|"Two short intravenous infusions (5 min each) of 7.5 g Idarucizumab verum administered (5 g + 2.5 g 1 h later) at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731361|NCT01688830|E24|Reported Event|DE+ 5 g|"One single intravenous short infusion (5 min) of 5 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731362|NCT01688830|E23|Reported Event|DE+ Placebo+ Placebo|"Two short intravenous infusions (5 min each) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731363|NCT01688830|E22|Reported Event|DE+ Placebo|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731364|NCT01688830|E21|Reported Event|DE (Dose Groups 17)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose group 17
731365|NCT01688830|E20|Reported Event|DE+ 2 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 2 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731366|NCT01688830|E19|Reported Event|DE+ 4 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 4 g Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731367|NCT01688830|E18|Reported Event|DE+ 1 g Idarucizumab 5min|"One single intravenous short infusion (5 min) of 1g of Idarucizumab verum administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731368|NCT01688830|E17|Reported Event|DE+ Placebo 5min|"One single intravenous short infusion (5 min) of Idarucizumab Placebo administered at or close to the steady state of Dabigatran etexilate (DE) 220 mg.~DE is administered orally :~Day 1 to 3: twice daily; Day 4: once daily"
731369|NCT01688830|E16|Reported Event|DE (Dose Groups 14−16)|Dabigatran etexilate (220 mg; 2 capsules, each 110 mg) was administered to subjects orally, both in the mornings and evenings of Days 1 to 3 and in the morning of Day 4 in dose groups 14-16
731370|NCT01688830|E15|Reported Event|4 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 4 g Idarucizumab verum
731371|NCT01688830|E14|Reported Event|2 g Idarucizumab 5min|Dose group 12: One single intravenous short infusion (5 min) of 2 g Idarucizumab verum
731372|NCT01688830|E13|Reported Event|1 g Idarucizumab 5min|One single intravenous short infusion (5 min) of 1 g Idarucizumab verum
731373|NCT01688830|E12|Reported Event|Placebo 5min|One single intravenous short infusion (5 min) of Idarucizumab Placebo
731374|NCT01688830|E11|Reported Event|8 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 8 g Idarucizumab verum
731375|NCT01688830|E10|Reported Event|6 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 6 g Idarucizumab verum
731376|NCT01688830|E9|Reported Event|4 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 4 g Idarucizumab verum
731377|NCT01688830|E8|Reported Event|3 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 3 g Idarucizumab verum
731378|NCT01688830|E7|Reported Event|2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 2 g Idarucizumab verum
731379|NCT01688830|E6|Reported Event|1.2 g Idarucizumab 1h|One single intravenous long infusion (1 h) of 1.2 g Idarucizumab verum
731383|NCT01688830|E2|Reported Event|20 mg Idarucizumab 1h|One single intravenous long infusion (1 h) of 20 mg Idarucizumab verum
731384|NCT01688830|E1|Reported Event|Placebo 1 h|One single intravenous long infusion (1 h) of Idarucizumab Placebo
731385|NCT01688726|B3|Baseline|Total|Total of all reporting groups
731386|NCT01688726|B2|Baseline|Minims Saline|One drop 4 times a day for a continuous period of 1 month
731387|NCT01688726|B1|Baseline|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
731388|NCT01688726|P2|Participant Flow|Minims Saline|One drop 4 times a day for a continuous period of 1 month
731389|NCT01688726|P1|Participant Flow|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
731390|NCT01688726|O4|Outcome|Minims Saline/Left Eye|One drop 4 times a day for 1 month
731391|NCT01688726|O3|Outcome|Minims Saline/Right Eye|One drop 4 times a day for 1 month
731392|NCT01688726|O2|Outcome|SYSTANE BALANCE/Left Eye|One drop 4 times a day for 1 month
731393|NCT01688726|O1|Outcome|SYSTANE BALANCE/Right Eye|One drop 4 times a day for 1 month
731394|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
731395|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
731396|NCT01688726|O2|Outcome|Minims Saline|One drop 4 times a day for a continuous period of 1 month
731397|NCT01688726|O1|Outcome|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
731398|NCT01688726|E2|Reported Event|Minims Saline|One drop 4 times a day for a continuous period of 1 month
731399|NCT01688726|E1|Reported Event|SYSTANE BALANCE|One drop 4 times a day for a continuous period of 1 month
731400|NCT01688635|B1|Baseline|LY2963016 and US-approved Lantus|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study; Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
731401|NCT01688635|P2|Participant Flow|Lantus/LY/Lantus/LY|"A single 0.5-U/kg dose of US-approved Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
731402|NCT01688635|P1|Participant Flow|LY/Lantus/LY/Lantus|"A single 0.5-units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5-U/kg dose of US-approved Lantus (Lantus) administered subcutaneously during Periods 2 and 4.~There was at least a 7-day washout between treatment periods."
731403|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
731404|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
731405|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
731406|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
731407|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
731408|NCT01688635|O1|Outcome|LY2963016|"Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
731409|NCT01688635|O2|Outcome|US-approved Lantus|"Single 0.5-U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between treatment periods."
731410|NCT01688635|O1|Outcome|LY2963016|Single 0.5-units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study. There was at least a 7-day washout between treatment periods.
731411|NCT01688635|E2|Reported Event|US-approved Lantus|"Single 0.5 U/kg dose of US-approved Lantus administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
731412|NCT01688635|E1|Reported Event|LY2963016|"Single 0.5 units per kilogram (U/kg) dose of LY2963016 administered subcutaneously twice during the study.~There was at least a 7-day washout between the treatment periods."
731413|NCT01688310|B3|Baseline|Total|Total of all reporting groups
731414|NCT01688310|B2|Baseline|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731415|NCT01688310|B1|Baseline|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731416|NCT01688310|P2|Participant Flow|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731417|NCT01688310|P1|Participant Flow|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731418|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731419|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731420|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731448|NCT01688050|E1|Reported Event|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
731421|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731422|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731423|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731424|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731425|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731426|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731427|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731428|NCT01688310|O2|Outcome|Junior Physicians|Physicians who had very limited prior experience performing open surgical circumcisions.
731429|NCT01688310|O1|Outcome|Senior Physicians|Physicians who had extensive prior experience performing open surgical circumcisions.
731430|NCT01688310|O2|Outcome|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731431|NCT01688310|O1|Outcome|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731432|NCT01688310|E2|Reported Event|Gomco Clamp With Tissue Adhesive|Coupling removal of the foreskin with the Gomco clamp followed by wound sealing with tissue adhesive results in a procedure that can be performed by generalist doctors using the same technique in all age groups.
731433|NCT01688310|E1|Reported Event|Open Surgical Circumcision|Open surgical techniques, which are commonly used for circumcision in Subsaharan Africa (and the only technique permitted by PEPFAR), require good surgical skills and minor complications are common.
731434|NCT01688102|B3|Baseline|Total|Total of all reporting groups
731435|NCT01688102|B2|Baseline|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
731436|NCT01688102|B1|Baseline|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
731437|NCT01688102|P2|Participant Flow|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
731438|NCT01688102|P1|Participant Flow|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
731439|NCT01688102|O2|Outcome|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
731440|NCT01688102|O1|Outcome|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
731441|NCT01688102|E2|Reported Event|Ultraviolet Light|"Subjects will receive 16 treatments with ultraviolet light (narrow band UVB) over 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of narrow band UVB.~Ultraviolet Light: 16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes"
731442|NCT01688102|E1|Reported Event|Oral Vitamin D3|"Participants will receive oral vitamin D3 50,000 units weekly for 8 weeks. If 25(OH)D levels remain <35 ng/ml, subjects will receive additional doses of oral vitamin D.~Oral Vitamin D3: 50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed"
731443|NCT01688050|B1|Baseline|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
731444|NCT01688050|P1|Participant Flow|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
731445|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
731446|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
731447|NCT01688050|O1|Outcome|Endovascular Repair|Zenith® TX2® Low Profile Endovascular Graft: Zenith® TX2® Low Profile Endovascular Graft
731449|NCT01687790|B1|Baseline|Molecular Breast Imaging|molecular breast imaging (Discovery)
731452|NCT01687790|O1|Outcome|Molecular Breast Imaging|Participants received molecular breast imaging before biopsy
731453|NCT01687790|E1|Reported Event|Molecular Breast Imaging|molecular breast imaging (Discovery)
731454|NCT01687270|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731455|NCT01687270|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily plus ribavirin (RBV) tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731456|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731457|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731458|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731459|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731460|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731461|NCT01687270|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731462|NCT01687270|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily plus RBV tablets (400 mg daily starting dose, then adjusted to 200-1200 mg daily) for 24 weeks
731463|NCT01687257|B3|Baseline|Total|Total of all reporting groups
731464|NCT01687257|B2|Baseline|SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
731465|NCT01687257|B1|Baseline|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731466|NCT01687257|P3|Participant Flow|Observation/SOF+RBV (Group 2; Received Treatment)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
731467|NCT01687257|P2|Participant Flow|Observation/SOF+RBV (Group 2; Not Treated)|This reporting group only includes participants who were randomized to the Observation/SOF+RBV group who discontinued study prior to receiving study drug.
731468|NCT01687257|P1|Participant Flow|SOF+RBV (Group 1)|Sofosbuvir (Sovaldi®; SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731469|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
731470|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
731471|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
731472|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
731473|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks in both Groups 1 and 2
731474|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
731475|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
731476|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
731477|NCT01687257|O4|Outcome|All SOF+RBV (Groups 1 and 2)|Participants who received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 48 weeks in both Groups 1 and 2
731478|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for 48 weeks
731479|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
731480|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet administered orally once daily + RBV tablets administered orally (1000 or 1200 mg daily based on weight) for up to 48 weeks
731481|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731482|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731483|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731484|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731485|NCT01687257|O2|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731486|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731487|NCT01687257|O3|Outcome|SOF+RBV (Group 2)|Participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731488|NCT01687257|O2|Outcome|Observation Period (Group 2)|24 weeks of observation
731489|NCT01687257|O1|Outcome|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731490|NCT01687257|E3|Reported Event|SOF+RBV Treatment Only (Group 2)|This reporting group includes participants who completed observation and received SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks.
731491|NCT01687257|E2|Reported Event|Observation Period Only (Group 2)|This reporting group includes participants who were randomized to the Observation/SOF+RBV group and received up to 24 weeks of observation.
731492|NCT01687257|E1|Reported Event|SOF+RBV (Group 1)|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for up to 48 weeks
731493|NCT01687244|B3|Baseline|Total|Total of all reporting groups
731494|NCT01687244|B2|Baseline|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11vps/ml of rAd-IFN/Syn3 arm.
731495|NCT01687244|B1|Baseline|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml of rAd-IFN/Syn3 arm.
731496|NCT01687244|P2|Participant Flow|rAd-IFN Dose 3x10^11 Vps/ml|"Patients were randomized to the 3x10^11vps/ml rAd-IFN/Syn3 arm.~A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
731497|NCT01687244|P1|Participant Flow|rAd-IFN Dose 1x10^11vps/ml|"Patients were randomized to the 1x10^11vps/ml rAd-IFN/Syn3 arm.~A 75 mL dose of rAd-IFN/Syn3 was given as a single, one-hour intravesical administration and, depending on clinical response, was repeated every 90 Days up to a maximum of 4 instilations."
731498|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/mL|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
731499|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731500|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731501|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731502|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731503|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731504|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731505|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
731509|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731510|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Subjects were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731511|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
731512|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731513|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731514|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731515|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731516|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731517|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731518|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731519|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomly assigned to the 1x10^11 vps/ml rAd-IFN/Syn3 arm.
731520|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11 Vps/ml|Patients were randomly assigned to the 3x10^11 vps/ml rAd-IFN/Syn3 arm.
731521|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11vps/ml|Patients were randomly assigned to the 1x10^11vps/ml rAd-IFN/Syn3 arm.
731522|NCT01687244|O2|Outcome|rAd-IFN Dose 3x10^11vps/ml|Patients were randomly assigned to the 3x10^11vps/ml rAd-IFN/Syn3 arm.
731523|NCT01687244|O1|Outcome|rAd-IFN Dose 1x10^11 Vps/ml|Subjects were randomly assigned to the 1x10^11 vps/mI rAd-IFN/Syn3 arm.
731524|NCT01687244|E2|Reported Event|rAd-IFN Dose 3x10^11vps/ml|Patients were randomized the 3x10^11 vps/ml INSTILADRIN arm.
731525|NCT01687244|E1|Reported Event|rAd-IFN Dose 1x10^11 Vps/ml|Patients were randomized to the 1x10^11 vps/ml INSTILADRIN arm.
731526|NCT01687218|B7|Baseline|Total|Total of all reporting groups
731527|NCT01687218|B6|Baseline|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731528|NCT01687218|B5|Baseline|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731529|NCT01687218|B4|Baseline|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731530|NCT01687218|B3|Baseline|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731562|NCT01687101|P1|Participant Flow|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
731531|NCT01687218|B2|Baseline|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731532|NCT01687218|B1|Baseline|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731533|NCT01687218|P6|Participant Flow|Group 6|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks);followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731534|NCT01687218|P5|Participant Flow|Group 5|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731578|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731579|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
732275|NCT01682876|E4|Reported Event|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
731535|NCT01687218|P4|Participant Flow|Group 4|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731536|NCT01687218|P3|Participant Flow|Group 3|"Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731537|NCT01687218|P2|Participant Flow|Group 2|"Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731538|NCT01687218|P1|Participant Flow|Group 1|"Daily Oral Emtricitabine/Tenofovir Disoproxil Fumarate Tablet (8 weeks); followed by Daily Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks); followed by Receptive Anal Intercourse Associated Rectally-Applied Tenofovir Reduced Glycerin 1% Gel (8 weeks)~Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)~Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)~Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)"
731539|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
731540|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
731541|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
731542|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
731543|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
731544|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
731545|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
731546|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
731547|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
731548|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
731549|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
731550|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
731551|NCT01687218|O3|Outcome|Product 3|Rectal (RAI-associated TFV RG 1% gel)
731552|NCT01687218|O2|Outcome|Product 2|Rectal (Daily TFV RG 1% gel)
731553|NCT01687218|O1|Outcome|Product 1|Oral (Daily FTC/TDF)
731554|NCT01687218|E3|Reported Event|Product 3|Rectal (RAI-associated TFV RG 1% gel)
731555|NCT01687218|E2|Reported Event|Product 2|Rectal (Daily TFV RG 1% gel)
731556|NCT01687218|E1|Reported Event|Product 1|Oral (Daily FTC/TDF)
731557|NCT01687114|B1|Baseline|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
731558|NCT01687114|P1|Participant Flow|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
731559|NCT01687114|O1|Outcome|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
731560|NCT01687114|E1|Reported Event|Cranberry Juice|"27% cranberry juice~cranberry juice: 27% cranberry juice"
731561|NCT01687101|B1|Baseline|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
731563|NCT01687101|O1|Outcome|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
731564|NCT01687101|E1|Reported Event|STOPAIN Topical Gel|STOPAIN gel which is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
731565|NCT01687088|B3|Baseline|Total|Total of all reporting groups
731566|NCT01687088|B2|Baseline|Controls|No significant headache or disability as defined by migraine disability scale.
731567|NCT01687088|B1|Baseline|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
731568|NCT01687088|P2|Participant Flow|Controls|No significant headache or disability as defined by migraine disability scale.
731569|NCT01687088|P1|Participant Flow|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
731570|NCT01687088|O2|Outcome|Controls|No significant headache or disability as defined by migraine disability scale.
731571|NCT01687088|O1|Outcome|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
731572|NCT01687088|E2|Reported Event|Controls|No significant headache or disability as defined by migraine disability scale.
731573|NCT01687088|E1|Reported Event|Chronic Migraineurs|At least 8 migraine days per week and headache at least 15 days per month.
731574|NCT01687036|B1|Baseline|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731575|NCT01687036|P1|Participant Flow|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System (single treatment during visit 3)."
731576|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731577|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731580|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731581|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731582|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731583|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731584|NCT01687036|O1|Outcome|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731585|NCT01687036|E1|Reported Event|Cryoablation|"Cryoablation~Cryoablation : Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System"
731586|NCT01686932|B3|Baseline|Total|Total of all reporting groups
731587|NCT01686932|B2|Baseline|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
731588|NCT01686932|B1|Baseline|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
731589|NCT01686932|P2|Participant Flow|Sitagliptin Followed by Vildagliptin|Period 1: sitagliptin 100mg QD for 8 weeks; followed by Washout then Period 2: vildagliptin 50mg BID for 8 weeks
731590|NCT01686932|P1|Participant Flow|Vildagliptin Followed by Sitagliptin|Period 1: vildagliptin 50mg BID for 8 weeks; followed by Washout then Period 2: sitagliptin 100mg QD for 8 weeks
731591|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731592|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731593|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731594|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731595|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731596|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731597|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731598|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731599|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731600|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731601|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731602|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731603|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731604|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731605|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731606|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731607|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731608|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731609|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731610|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731611|NCT01686932|O2|Outcome|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731612|NCT01686932|O1|Outcome|Vitagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731613|NCT01686932|E2|Reported Event|Sitagliptin|For all Sitagliptin 100mg QD for 8 weeks in Period 1 and 8 weeks in Period 2
731614|NCT01686932|E1|Reported Event|Vildagliptin|For all Vitagliptin 50mg BID for 8 weeks in Period 1 and 8 weeks in Period 2
731615|NCT01686828|B5|Baseline|Total|Total of all reporting groups
731616|NCT01686828|B4|Baseline|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
731617|NCT01686828|B3|Baseline|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731618|NCT01686828|B2|Baseline|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731619|NCT01686828|B1|Baseline|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731620|NCT01686828|P4|Participant Flow|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
731621|NCT01686828|P3|Participant Flow|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731622|NCT01686828|P2|Participant Flow|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731623|NCT01686828|P1|Participant Flow|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731624|NCT01686828|O4|Outcome|Acyline + Testosterone Gel (5g/d) + Letrozole|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily letrozole (pills). This group was intended to have normal levels of serum testosterone with selective estrogen deficiency.
731625|NCT01686828|O3|Outcome|Acyline + Testosterone Gel (5g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have normal, physiologic levels of serum testosterone and estradiol.
731626|NCT01686828|O2|Outcome|Acyline + Testosterone Gel (1.25g/d) + Placebo Pills|Acyline (300 mcg/kg, subcutaneous injection at weeks 0, 2) + testosterone gel administered daily + daily placebo pills. This group was intended to have low-normal levels of serum testosterone and estradiol.
731627|NCT01686828|O1|Outcome|Acyline + Placebo Gel + Placebo Pills|Acyline (300 mg/kg, subcutaneous injection at weeks 0, 2) + placebo gel + oral placebo pills daily. This treatment regimen resulted in medical castration.
731628|NCT01686828|O4|Outcome|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
731629|NCT01686828|O3|Outcome|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731630|NCT01686828|O2|Outcome|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731631|NCT01686828|O1|Outcome|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731632|NCT01686828|O4|Outcome|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
731664|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731633|NCT01686828|O3|Outcome|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731634|NCT01686828|O2|Outcome|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731635|NCT01686828|O1|Outcome|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731636|NCT01686828|E4|Reported Event|Acyline & Testosterone Gel & Letrozole|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone transdermal 1.62% gel (5g) daily + letrozole (5mg) aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Letrozole: Letrozole oral aromatase inhibitor 5mg daily for 4 weeks"
731637|NCT01686828|E3|Reported Event|Acyline & Testosterone Gel 5g/d & Placebo Pill|"Acyline (300mcg/kg every 2 weeks, by injections) + Testosterone 1.62% gel (5g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731638|NCT01686828|E2|Reported Event|Acyline & Testosterone Gel 1.25g/d & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + Testosterone 1.62% gel (1.25g) daily + placebo aromatase inhibitor pill daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Testosterone 1.62% gel: Transdermal Testosterone Gel (either 3.75g or 5g/d) for 4 weeks~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731639|NCT01686828|E1|Reported Event|Acyline & Placebo Gel & Placebo Pill|"Acyline (300mcg/kg at Day 0 & week 2, by injections) + placebo transdermal gel + placebo aromatase inhibitor daily for 4 weeks~Acyline: 300 mcg/mL administered subcutaneously (at Day 0, Week 2)~Placebo gel (for Testosterone 1.62% gel): placebo gel manufactured to mimic Testosterone 1.62% gel~Placebo pill (for Letrozole): Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d"
731640|NCT01686646|B5|Baseline|Total|Total of all reporting groups
731641|NCT01686646|B4|Baseline|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731642|NCT01686646|B3|Baseline|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731643|NCT01686646|B2|Baseline|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731644|NCT01686646|B1|Baseline|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731645|NCT01686646|P4|Participant Flow|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731646|NCT01686646|P3|Participant Flow|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731647|NCT01686646|P2|Participant Flow|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731648|NCT01686646|P1|Participant Flow|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 milligrams [mg] ) and caffeine (65 mg) tablets were dissolved in 200 milliliter (mL) of water and administered orally.
731649|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731650|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731651|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731652|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731653|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731654|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731655|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731656|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731657|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731658|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731659|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731660|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731661|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731662|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731663|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731665|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731666|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731667|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731668|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731669|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731670|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731671|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731672|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731673|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731674|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731675|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731676|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731677|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731678|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731679|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731680|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731681|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731682|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731683|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731684|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731685|NCT01686646|O4|Outcome|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731686|NCT01686646|O3|Outcome|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731687|NCT01686646|O2|Outcome|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731688|NCT01686646|O1|Outcome|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731689|NCT01686646|E4|Reported Event|Paracetamol (500)|One paracetamol tablet (500 mg) was dissolved in 200 mL of water and administered orally.
731690|NCT01686646|E3|Reported Event|Paracetamol + Caffeine Combination (500/65)|One paracetamol (500 mg) and caffeine (65 mg) tablet was dissolved in 200 mL of water and administered orally.
731691|NCT01686646|E2|Reported Event|Paracetamol (1000)|Two paracetamol tablets (500 mg each) were dissolved in 200 mL of water and administered orally.
731692|NCT01686646|E1|Reported Event|Paracetamol + Caffeine Combination (1000/130)|Two paracetamol (500 mg) and caffeine (65 mg) tablets were dissolved in 200 mL of water and administered orally.
731693|NCT01686633|B4|Baseline|Total|Total of all reporting groups
731694|NCT01686633|B3|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731695|NCT01686633|B2|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731696|NCT01686633|B1|Baseline|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731697|NCT01686633|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731698|NCT01686633|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731699|NCT01686633|P1|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder once daily (OD) in the evening from a dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731700|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731701|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731734|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731702|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731703|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731704|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731705|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731706|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731707|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731708|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731709|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731710|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
732216|NCT01684007|E2|Reported Event|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
731711|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731712|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731713|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731714|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731715|NCT01686633|O3|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731716|NCT01686633|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731717|NCT01686633|O1|Outcome|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731718|NCT01686633|E3|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731719|NCT01686633|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731720|NCT01686633|E1|Reported Event|FF 100 µg OD|Participants received FF 100 µg inhalation powder OD in the evening from a DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
731721|NCT01686568|B3|Baseline|Total|Total of all reporting groups
731722|NCT01686568|B2|Baseline|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731723|NCT01686568|B1|Baseline|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731724|NCT01686568|P2|Participant Flow|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731725|NCT01686568|P1|Participant Flow|Omega-3|Patients in this group will receive oral supplementation with EPA + Docosahexaenoic acid (DHA) (3.9grams/day) for 6 months.
731726|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731727|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731728|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731729|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731730|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731731|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731732|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731733|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731735|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731736|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731737|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731738|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731739|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731740|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731741|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731742|NCT01686568|O2|Outcome|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731743|NCT01686568|O1|Outcome|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731744|NCT01686568|E2|Reported Event|Placebo|Patients in this group will be supplemented with placebo capsules containing ethyl oleate.
731745|NCT01686568|E1|Reported Event|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
731746|NCT01686503|B5|Baseline|Total|Total of all reporting groups
731747|NCT01686503|B4|Baseline|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731748|NCT01686503|B3|Baseline|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731749|NCT01686503|B2|Baseline|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731750|NCT01686503|B1|Baseline|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731751|NCT01686503|P4|Participant Flow|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731752|NCT01686503|P3|Participant Flow|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731753|NCT01686503|P2|Participant Flow|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731754|NCT01686503|P1|Participant Flow|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731755|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731756|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731757|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731758|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731759|NCT01686503|O4|Outcome|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731855|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731760|NCT01686503|O3|Outcome|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731761|NCT01686503|O2|Outcome|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731762|NCT01686503|O1|Outcome|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731763|NCT01686503|E4|Reported Event|2/5 Dose Intramuscular IPV|"Participants in this study arm will receive 2/5 dose (0.2 mL) inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731764|NCT01686503|E3|Reported Event|Full Dose Intramuscular IPV|"Participants in this study arm will receive the standard full dose (0.5 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intramuscularly.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731765|NCT01686503|E2|Reported Event|1/5 Dose Intadermal IPV|"Participants in this study arm will receive 1/5 dose (0.1 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one time dose intradermally using the NanoPass MicronJet 600 microneedle device.~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731766|NCT01686503|E1|Reported Event|2/5 Dose Intradermal IPV|"Participants in this arm will receive 2/5 dose (0.2 mL) of inactivated polio vaccine (IPOL, Sanofi Pasteur) as a one-time dose intradermally using the NanoPass MicronJet 600 microneedle device~IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose: Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly."
731767|NCT01686451|B3|Baseline|Total|Total of all reporting groups
731768|NCT01686451|B2|Baseline|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731769|NCT01686451|B1|Baseline|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731770|NCT01686451|P2|Participant Flow|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731771|NCT01686451|P1|Participant Flow|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731772|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731773|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731774|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731775|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731776|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731777|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731778|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731779|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731780|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731781|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731782|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731783|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731784|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731785|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731786|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731787|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731856|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731788|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731789|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731790|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731791|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731792|NCT01686451|O4|Outcome|XueZhiKang/Week 4|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731793|NCT01686451|O3|Outcome|XueZhiKang/Baseline|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731794|NCT01686451|O2|Outcome|Simvastatin/Week 4|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731795|NCT01686451|O1|Outcome|Simvastatin/Baseline|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731796|NCT01686451|E2|Reported Event|XueZhiKang|"Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.~XueZhiKang : Participants will receive 600mg of XueZhiKang twice a day for 4 weeks."
731797|NCT01686451|E1|Reported Event|Simvastatin|"Participants will receive 20mg of simvastatin daily for 4 weeks.~simvastatin : Participants will receive 20mg of simvastatin daily for 4 weeks."
731798|NCT01685996|B3|Baseline|Total|Total of all reporting groups
731799|NCT01685996|B2|Baseline|Placebo|Participants receive placebo + varenicline for smoking cessation
731800|NCT01685996|B1|Baseline|Zonisamide|Participants receive zonisamide + varenicline for smoking cessation
731801|NCT01685996|P2|Participant Flow|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
731802|NCT01685996|P1|Participant Flow|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
731803|NCT01685996|O2|Outcome|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
731804|NCT01685996|O1|Outcome|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
731805|NCT01685996|O2|Outcome|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
731806|NCT01685996|O1|Outcome|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
731807|NCT01685996|E2|Reported Event|Placebo|"Participants will receive placebo capsules to take once a day~placebo"
731808|NCT01685996|E1|Reported Event|Zonisamide|"participants will receive zonisamide capsules (up to 300 mg) to take once a day.~zonisamide: In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline"
731809|NCT01685983|B1|Baseline|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731810|NCT01685983|P1|Participant Flow|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731811|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731812|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731813|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731814|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731815|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731816|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731817|NCT01685983|O1|Outcome|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731818|NCT01685983|E1|Reported Event|Abiraterone Acetate and Prednisolone|Abiraterone acetate 1,000 milligram (mg) (administered as 4 * 250 mg tablets) orally once daily at least 1 hour before or 2 hours after a meal, and prednisolone 5 mg orally twice daily until documentation of disease progression or unacceptable toxicity.
731819|NCT01685801|B5|Baseline|Total|Total of all reporting groups
731820|NCT01685801|B4|Baseline|PIPI|Detailed reporting group description is provided in Participant Flow module.
731821|NCT01685801|B3|Baseline|PIIP|Detailed reporting group description is provided in Participant Flow module.
731822|NCT01685801|B2|Baseline|IPPI|Detailed reporting group description is provided in Participant Flow module.
731823|NCT01685801|B1|Baseline|IPIP|Detailed reporting group description is provided in Participant Flow module.
731824|NCT01685801|P4|Participant Flow|Placebo, Ivacaftor, Placebo, Ivacaftor (PIPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
731825|NCT01685801|P3|Participant Flow|Placebo, Ivacaftor, Ivacaftor, Placebo (PIIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
731826|NCT01685801|P2|Participant Flow|Ivacaftor, Placebo, Placebo, Ivacaftor (IPPI)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
731907|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731827|NCT01685801|P1|Participant Flow|Ivacaftor, Placebo, Ivacaftor, Placebo (IPIP)|During the Crossover Period, study drug was administered in 2-week alternating cycles with a minimum of 4-week washout period between Cycle 1 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and Cycle 2 [(Period 1 - Day 1 to 14) (Period 2 - Day 15 to 29)] and between Cycle 2 and the Open-label Period (Day 1 to 57). During the Open-label Period, all participants received ivacaftor.
731828|NCT01685801|O3|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
731829|NCT01685801|O2|Outcome|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
731830|NCT01685801|O1|Outcome|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
731831|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
731832|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
731833|NCT01685801|O1|Outcome|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours in open-label period (8 weeks) after washout period 2.
731834|NCT01685801|O1|Outcome|Open-Label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
731835|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 2.
731836|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
731837|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of cycle 1.
731838|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
731839|NCT01685801|O4|Outcome|Cycle 2: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
731840|NCT01685801|O3|Outcome|Cycle 2: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 2.
731841|NCT01685801|O2|Outcome|Cycle 1: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
731842|NCT01685801|O1|Outcome|Cycle 1: Placebo|Placebo-matched-to-ivacaftor tablet orally every 12 hours for 2 weeks during either in period 1 or 2 of Cycle 1.
731843|NCT01685801|E3|Reported Event|Open-label Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 8 weeks during the open-label period after washout period 2.
731844|NCT01685801|E2|Reported Event|Crossover Double-blind Period: Ivacaftor|Ivacaftor 150 mg tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
731845|NCT01685801|E1|Reported Event|Crossover Double-blind Period: Placebo|Placebo matched to ivacaftor tablet orally every 12 hours for 2 weeks either during the double blind period 1 or 2 of cycle 1 and cycle 2.
731846|NCT01685684|B3|Baseline|Total|Total of all reporting groups
731847|NCT01685684|B2|Baseline|Placebo (Double-blind Maintenance Phase)|
731848|NCT01685684|B1|Baseline|Oxycodone DETERx (Double-blind Maintenance Phase)|
731849|NCT01685684|P3|Participant Flow|Placebo (Double-blind Maintenance Phase)|Placebo: Placebo, divided into 2 doses, q12h
731850|NCT01685684|P2|Participant Flow|Oxycodone DETERx (Double-blind Maintenance Phase)|Oxycodone DETERx: 40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
731851|NCT01685684|P1|Participant Flow|Oxycodone DETERx (Titration Phase)|Achieve a stable Oxycodone DETERx dose of 40-160 mg total daily dose.
731852|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731853|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731854|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731857|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731858|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731859|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731860|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731861|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731862|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731863|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731864|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731865|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731866|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731867|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731868|NCT01685684|O2|Outcome|Placebo (Double-blind Maintenance Phase)|
731869|NCT01685684|O1|Outcome|Oxycodone DETERx (Double-blind Maintenance Phase)|
731870|NCT01685684|E4|Reported Event|Placebo (Double-blind Maintenance Phase)|
731871|NCT01685684|E3|Reported Event|Oxycodone DETERx (Double-blind Maintenance Phase)|
731872|NCT01685684|E2|Reported Event|Oxycodone DETERx (Titration Phase)|
731873|NCT01685684|E1|Reported Event|Screening|Serious Adverse Event (SAE) collection started during screening.
731874|NCT01685606|B1|Baseline|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
731875|NCT01685606|P1|Participant Flow|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
731876|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
731877|NCT01685606|O1|Outcome|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
731878|NCT01685606|E1|Reported Event|Cellular Immunotherapy|"A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor will be infused, irrespective of the number of CD34+ cells.~cellular immunotherapy: A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused."
731879|NCT01685567|B1|Baseline|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731880|NCT01685567|P1|Participant Flow|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731881|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731882|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731883|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731884|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731885|NCT01685567|O1|Outcome|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731886|NCT01685567|E1|Reported Event|Intention-to-Treat (ITT)|All patients who were enrolled in the pivotal phase of the study are included. Lead-in patients are not included in this group.
731887|NCT01685437|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731888|NCT01685437|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731889|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731890|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731891|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731892|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731893|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731894|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731895|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731896|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731897|NCT01685437|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731898|NCT01685437|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles"
731899|NCT01685320|B3|Baseline|Total|Total of all reporting groups
731900|NCT01685320|B2|Baseline|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731901|NCT01685320|B1|Baseline|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731902|NCT01685320|P2|Participant Flow|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731903|NCT01685320|P1|Participant Flow|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731904|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731905|NCT01685320|O1|Outcome|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731906|NCT01685320|O2|Outcome|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731908|NCT01685320|E2|Reported Event|Indirect Laryngoscope|Includes cases in which the forces applied by GlideScope indirect laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731909|NCT01685320|E1|Reported Event|Direct Laryngoscope|Includes cases in which the forces applied by McIntosh direct laryngoscope onto soft tissue of the pharynx during glottis visualization and intubation were measured using film pressure transducers.
731910|NCT01685216|B1|Baseline|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731911|NCT01685216|P1|Participant Flow|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731912|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731913|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731914|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731915|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731916|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731917|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731918|NCT01685216|O1|Outcome|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731919|NCT01685216|E1|Reported Event|Velaglucerase Alfa|Participants received an intravenous (IV) infusion of velaglucerase alfa at 60 U/kg, every other week for 1 year, then were followed for 1 month.
731920|NCT01685203|B8|Baseline|Total|Total of all reporting groups
731921|NCT01685203|B7|Baseline|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731922|NCT01685203|B6|Baseline|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
731923|NCT01685203|B5|Baseline|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
731924|NCT01685203|B4|Baseline|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731925|NCT01685203|B3|Baseline|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731926|NCT01685203|B2|Baseline|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731927|NCT01685203|B1|Baseline|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731928|NCT01685203|P7|Participant Flow|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731929|NCT01685203|P6|Participant Flow|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
732250|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
731930|NCT01685203|P5|Participant Flow|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
731931|NCT01685203|P4|Participant Flow|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731932|NCT01685203|P3|Participant Flow|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731933|NCT01685203|P2|Participant Flow|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731934|NCT01685203|P1|Participant Flow|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731935|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731936|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
731937|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
731938|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731939|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731940|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731941|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731942|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731943|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
731944|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
731945|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731946|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731947|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731948|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731949|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731950|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
731951|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
731952|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731953|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731954|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731955|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731956|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731957|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
731958|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
731959|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731960|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731961|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731962|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731963|NCT01685203|O7|Outcome|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731964|NCT01685203|O6|Outcome|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
731965|NCT01685203|O5|Outcome|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/RBV (pegIFN/RBV) treatment-experienced participants
731966|NCT01685203|O4|Outcome|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731967|NCT01685203|O3|Outcome|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731968|NCT01685203|O2|Outcome|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731969|NCT01685203|O1|Outcome|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731970|NCT01685203|E7|Reported Event|Group 8|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, pegylated-interferon/ RBV(pegIFN/RBV) treatment-experienced participants with compensated cirrhosis
731971|NCT01685203|E6|Reported Event|Group 7|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 24 weeks to adult, HCV GT1b-infected, treatment-naïve participants with compensated cirrhosis
731972|NCT01685203|E5|Reported Event|Group 6|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, HCV GT4-infected, pegylated-interferon/ RBV (pegIFN/RBV) treatment-experienced participants
731973|NCT01685203|E4|Reported Event|Group 4|ABT-450 150 mg/ r 100 mg, ABT-267 25 mg , once daily and weight-based ribavirin (RBV; 1,000 mg/day if < 75 kg or 1,200 mg/day if ≥ 75 kg, divided twice daily) for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731974|NCT01685203|E3|Reported Event|Group 3|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, HCV GT1b-infected, pegylated-interferon/ribavirin (pegIFN/RBV) treatment null responder participants
731975|NCT01685203|E2|Reported Event|Group 2|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve HCV GT1b-infected participants
731976|NCT01685203|E1|Reported Event|Group 1|ABT-450 150 mg/ r 100 mg, and ABT-267 25 mg once daily for 12 weeks to adult noncirrhotic, treatment-naïve, HCV GT4-infected participants
731977|NCT01685060|B1|Baseline|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731978|NCT01685060|P1|Participant Flow|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731979|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731980|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731981|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731982|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731983|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731984|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731985|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731986|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731987|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731988|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731989|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731990|NCT01685060|O1|Outcome|LDK378 750mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731991|NCT01685060|E1|Reported Event|LDK378 750 mg|Patients treated with ceritinib/LDK378 750 mg once-daily, fasted.
731992|NCT01684930|B3|Baseline|Total|Total of all reporting groups
731993|NCT01684930|B2|Baseline|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
732013|NCT01684878|P3|Participant Flow|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
731994|NCT01684930|B1|Baseline|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
731995|NCT01684930|P2|Participant Flow|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
731996|NCT01684930|P1|Participant Flow|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
732024|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
731997|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
731998|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
731999|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
732000|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
732014|NCT01684878|P2|Participant Flow|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
732015|NCT01684878|P1|Participant Flow|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
732040|NCT01684839|O1|Outcome|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
732251|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732001|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
732002|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
732003|NCT01684930|O2|Outcome|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
732004|NCT01684930|O1|Outcome|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
732217|NCT01684007|E1|Reported Event|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
732005|NCT01684930|E2|Reported Event|BR Juice Placebo and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot; Placebo) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of placebo beverage and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot (Placebo) 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training: The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training."
732006|NCT01684930|E1|Reported Event|BR Juice (Beet-It Stamina Shot) and Exercise Training|"Subjects consume 70 ml of Beetroot Juice (Beet-It Stamina Shot) to assess acute effects of beverage supplementation at the start (between Testing Visits 1 & 2) and at the end of the trial (between Visits 3 & 4). It also allows for comparisons of the combination of beetroot juice and chronic training effects (between Visits 2 & 3) to when the subject has not consumed the beverage (Visits 1 & 4). All subjects will consume Beet-It Stamina Shot 3 hours prior to all beverage tolerance visits, Testing Visits 2 & 3 and for all supervised exercise training visits during the 12 week intervention.~Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training: The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training."
732007|NCT01684878|B5|Baseline|Total|Total of all reporting groups
732008|NCT01684878|B4|Baseline|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732009|NCT01684878|B3|Baseline|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732010|NCT01684878|B2|Baseline|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
732011|NCT01684878|B1|Baseline|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
732012|NCT01684878|P4|Participant Flow|Part 2: Placebo+Chemotherapy|Participants received pertuzumab-matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732089|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732016|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732017|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732018|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732019|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732020|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732021|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732022|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732023|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732218|NCT01682954|B3|Baseline|Total|Total of all reporting groups
732219|NCT01682954|B2|Baseline|Usual Care|Usual care from primary care physician
732025|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
732026|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732027|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732028|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
732029|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
732030|NCT01684878|O2|Outcome|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732031|NCT01684878|O1|Outcome|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732032|NCT01684878|O2|Outcome|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
732033|NCT01684878|O1|Outcome|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigators assessment, unacceptable toxicity, withdrawal of consent, or death.
732034|NCT01684878|E4|Reported Event|Part 2: Placebo+Chemotherapy|Participants received pertuzumab matching placebo and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732035|NCT01684878|E3|Reported Event|Part 2: Pertuzumab+Chemotherapy|Participants received pertuzumab and chemotherapy (paclitaxel or topotecan or gemcitabine) in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death. Chemotherapy was administered as per investigators discretion.
732036|NCT01684878|E2|Reported Event|Part 1: Pertuzumab + Paclitaxel|Participants received pertuzumab and paclitaxel in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
732037|NCT01684878|E1|Reported Event|Part 1: Pertuzumab + Topotecan|Participants received pertuzumab and topotecan in cycles of 3 weeks until progressive disease as per investigator's assessment, unacceptable toxicity, withdrawal of consent, or death.
732038|NCT01684839|B1|Baseline|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
732039|NCT01684839|P1|Participant Flow|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
732041|NCT01684839|E1|Reported Event|New Surgical Treatment|Treatment of Painful Digital Neuroma Using A Pedicled Nerve Flap taken from the homolateral dorsal branch of the digital nerve.
732042|NCT01684826|B1|Baseline|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
732043|NCT01684826|P1|Participant Flow|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
732044|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
732045|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
732046|NCT01684826|O1|Outcome|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
732047|NCT01684826|E1|Reported Event|AlluraXper-ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
732048|NCT01684748|B3|Baseline|Total|Total of all reporting groups
732049|NCT01684748|B2|Baseline|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
732050|NCT01684748|B1|Baseline|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
732072|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732105|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732273|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732051|NCT01684748|P2|Participant Flow|No Drug First, Then Olmesartan Medoxomil|During the First Intervention (8 weeks), no drug will be administered to the subjects. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects then receive daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period.
732052|NCT01684748|P1|Participant Flow|Olmesartan Medoxomil First, Then No Drug|"During the First Intervention (8 weeks), subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period (6 weeks). The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks. In addition, subjects will continue taking the drug during the 2-week follow-up testing period. Subjects will then proceed to the Washout period (2 weeks). During the Second Intervention (8 weeks), no drug will be administered to the subjects.~Olmesartan medoxomil"
732053|NCT01684748|O2|Outcome|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
732054|NCT01684748|O1|Outcome|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
732055|NCT01684748|E2|Reported Event|No Drug Intervention|The no-drug intervention (i.e., no placebo is provided) is an 8-week no intervention comparison.
732056|NCT01684748|E1|Reported Event|Olmesartan Medoxomil|"Subjects will be provided with daily 20 mg of olmesartan for the first 2 weeks during the 8-week intervention. Subjects receive additional daily doses of 40 mg olmesartan for the remainder of the study period. The dose remains at 20 mg per day, however, if BP falls below 110/70 during the first 2 weeks, subjects will continue taking the drug during the 2-week follow-up period.~Olmesartan medoxomil"
732057|NCT01684566|B3|Baseline|Total|Total of all reporting groups
732058|NCT01684566|B2|Baseline|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732059|NCT01684566|B1|Baseline|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732060|NCT01684566|P2|Participant Flow|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732061|NCT01684566|P1|Participant Flow|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732062|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732090|NCT01684436|E1|Reported Event|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732091|NCT01684410|B4|Baseline|Total|Total of all reporting groups
732092|NCT01684410|B3|Baseline|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
732063|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732064|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732065|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732066|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732067|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732068|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732069|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732070|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732071|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732073|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732074|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732075|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732076|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732077|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732078|NCT01684566|O2|Outcome|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732079|NCT01684566|O1|Outcome|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732080|NCT01684566|E2|Reported Event|Standard-Of-Care|"Oral hygiene procedures~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732081|NCT01684566|E1|Reported Event|Standard-Of-Care + Episil(R)|"Standard-Of-Care plus episil® administered as three consecutive pump-strokes for a total volume of 0.45 mL applied 3 times daily and additionally, as needed~episil(R): episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.~Oral hygiene procedures: Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)"
732082|NCT01684436|B1|Baseline|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732083|NCT01684436|P1|Participant Flow|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732084|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732085|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732086|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732087|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732088|NCT01684436|O1|Outcome|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
732093|NCT01684410|B2|Baseline|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732094|NCT01684410|B1|Baseline|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732095|NCT01684410|P3|Participant Flow|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
732096|NCT01684410|P2|Participant Flow|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732097|NCT01684410|P1|Participant Flow|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732098|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
732099|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732100|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732101|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
732102|NCT01684410|O2|Outcome|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732103|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732104|NCT01684410|O3|Outcome|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
732211|NCT01684007|P1|Participant Flow|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
732106|NCT01684410|O1|Outcome|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732107|NCT01684410|E3|Reported Event|Placebo|"Placebo inhaled daily via nebulizer for 3 weeks. Placebo (phosphate buffer saline with polysorbate).~Placebo"
732108|NCT01684410|E2|Reported Event|Alpha-1 HC 200 mg|"200 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732109|NCT01684410|E1|Reported Event|Alpha-1 HC 100 mg|"100 mg of aerosolized Alpha-1 HC inhaled daily via nebulizer for 3 weeks.~Alpha-1 HC: Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma."
732110|NCT01684215|B5|Baseline|Total|Total of all reporting groups
732111|NCT01684215|B4|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732112|NCT01684215|B3|Baseline|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732113|NCT01684215|B2|Baseline|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732114|NCT01684215|B1|Baseline|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732115|NCT01684215|P4|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732116|NCT01684215|P3|Participant Flow|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732117|NCT01684215|P2|Participant Flow|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732118|NCT01684215|P1|Participant Flow|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732119|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732120|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732121|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732122|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732123|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732124|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732125|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732126|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732212|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
732213|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
732127|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732128|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732129|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732130|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732131|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732132|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732133|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732134|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732135|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732136|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732137|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732138|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732139|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732140|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732141|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732142|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732143|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732144|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732145|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732146|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732147|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732148|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732149|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732150|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732151|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732152|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732153|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732154|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732155|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732192|NCT01684046|P2|Participant Flow|RevitaLens - PureMoist|RevitaLens MPDS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
732156|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732157|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732158|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732159|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732160|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732161|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732162|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732214|NCT01684007|O2|Outcome|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
732215|NCT01684007|O1|Outcome|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
732163|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732164|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732165|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732166|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732167|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732168|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732169|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732170|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732171|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732172|NCT01684215|O4|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732173|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732174|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732175|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732176|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732177|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732178|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732179|NCT01684215|O3|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732180|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732274|NCT01682876|E5|Reported Event|Total|Total Population
732181|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732182|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732183|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732184|NCT01684215|O1|Outcome|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732185|NCT01684215|O2|Outcome|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732186|NCT01684215|O1|Outcome|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732187|NCT01684215|E4|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: Expanded Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732188|NCT01684215|E3|Reported Event|PD-0332991 125 mg+ Letrozole 2.5 mg: MTD Cohort|Participants received Letrozole 2.5 mg tablet along with PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732189|NCT01684215|E2|Reported Event|PD-0332991 125 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 125 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 125 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732190|NCT01684215|E1|Reported Event|PD-0332991 100 mg: Dose Escalation Cohort|Participants received single oral dose of PD-0332991 100 mg capsule in lead-in period (7 days prior to Cycle 1 Day 1), followed by PD-0332991 100 mg capsule orally once daily continuously for 21 days followed by 7 days off treatment in each cycle of 28 days, unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
732191|NCT01684046|B1|Baseline|PureMoist / RevitaLens|Opti-Free® PureMoist® MPDS and RevitaLens MPDS used during Period 1 and Period 2 in randomized order in crossover assignment.
732193|NCT01684046|P1|Participant Flow|PureMoist - RevitaLens|Opti-Free® PureMoist® MPDS, followed by RevitaLens MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
732194|NCT01684046|O2|Outcome|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732195|NCT01684046|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732196|NCT01684046|E2|Reported Event|RevitaLens|RevitaLens MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732197|NCT01684046|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732198|NCT01684033|B1|Baseline|PureMoist / Biotrue|Opti-Free® PureMoist® MPDS and Biotrue™ MPS used during Period 1 and Period 2 in randomized order in crossover assignment.
732199|NCT01684033|P2|Participant Flow|Biotrue - PureMoist|Biotrue™ MPS, followed by Opti-Free® PureMoist® MPDS. Each product used as indicated for 30 days with participant's habitual contact lenses.
732200|NCT01684033|P1|Participant Flow|PureMoist - Biotrue|Opti-Free® PureMoist® MPDS, followed by Biotrue™ MPS. Each product used as indicated for 30 days with participant's habitual contact lenses.
732201|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732202|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732203|NCT01684033|O2|Outcome|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732204|NCT01684033|O1|Outcome|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732205|NCT01684033|E2|Reported Event|Biotrue|Biotrue™ MPS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732206|NCT01684033|E1|Reported Event|PureMoist|Opti-Free® PureMoist® MPDS used during Period 1 or Period 2 for 30 days with participant's habitual contact lenses.
732207|NCT01684007|B3|Baseline|Total|Total of all reporting groups
732208|NCT01684007|B2|Baseline|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
732209|NCT01684007|B1|Baseline|Bilateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL, bilateral implantation
732210|NCT01684007|P2|Participant Flow|Contralateral|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL and AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, contralateral implantation
732220|NCT01682954|B1|Baseline|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
732221|NCT01682954|P2|Participant Flow|Usual Care|Usual care from primary care physician
732222|NCT01682954|P1|Participant Flow|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
732223|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
732224|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
732225|NCT01682954|O2|Outcome|Usual Care|Usual care from primary care physician
732226|NCT01682954|O1|Outcome|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
732227|NCT01682954|E2|Reported Event|Usual Care|Usual care from primary care physician
732228|NCT01682954|E1|Reported Event|Lifestyle Counseling|"Diabetes Prevention Program lifestyle intervention~Lifestyle counseling: 16-week nutrition, physical activity and behavioral intervention"
732229|NCT01682876|B5|Baseline|Total|Total of all reporting groups
732230|NCT01682876|B4|Baseline|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732231|NCT01682876|B3|Baseline|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732232|NCT01682876|B2|Baseline|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732233|NCT01682876|B1|Baseline|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732234|NCT01682876|P4|Participant Flow|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732235|NCT01682876|P3|Participant Flow|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732236|NCT01682876|P2|Participant Flow|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732237|NCT01682876|P1|Participant Flow|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732238|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732239|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732240|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732241|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732242|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732243|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732244|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732245|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732246|NCT01682876|O2|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732247|NCT01682876|O1|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732248|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732249|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732252|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732253|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732254|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732255|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732256|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732257|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732258|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732259|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732260|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732261|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732262|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732263|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732264|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732265|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732266|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732267|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732268|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732269|NCT01682876|O1|Outcome|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732270|NCT01682876|O4|Outcome|6 Through 10 Years (1 Vac)|Subjects 6-10 years of age received one MenACWY-CRM vaccination
732271|NCT01682876|O3|Outcome|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732272|NCT01682876|O2|Outcome|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732276|NCT01682876|E3|Reported Event|6 Through 10 Years (2 Vac)|Subjects 6-10 years of age received two MenACWY-CRM vaccinations
732277|NCT01682876|E2|Reported Event|2 Through 5 Years (1 Vac)|Subjects 2-5 years of age received one MenACWY-CRM vaccination
732278|NCT01682876|E1|Reported Event|2 Through 5 Years (2 Vac)|Subjects 2-5 years of age received two MenACWY-CRM vaccinations
732279|NCT01682863|B4|Baseline|Total|Total of all reporting groups
732280|NCT01682863|B3|Baseline|QAB149 75 ug od|
732281|NCT01682863|B2|Baseline|QVA149 27.5/25 ug Bid|
732282|NCT01682863|B1|Baseline|QVA149 27.5/12.5 ug Bid|
732283|NCT01682863|P3|Participant Flow|QAB149 75 ug od|
732284|NCT01682863|P2|Participant Flow|QVA149 27.5/25 ug Bid|
732285|NCT01682863|P1|Participant Flow|QVA149 27.5/12.5 ug Bid|
732286|NCT01682863|O3|Outcome|QAB149 75 ug od|
732287|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732288|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732289|NCT01682863|O3|Outcome|QAB149 75 ug od|
732290|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732291|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732292|NCT01682863|O3|Outcome|QAB149 75 ug od|
732293|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732294|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732295|NCT01682863|O3|Outcome|QAB149 75 ug od|
732296|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732297|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732298|NCT01682863|O3|Outcome|QAB149 75 ug od|
732299|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732300|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732301|NCT01682863|O3|Outcome|QAB149 75 ug od|
732302|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732303|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732304|NCT01682863|O3|Outcome|QAB149 75 ug od|
732305|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732306|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732307|NCT01682863|O3|Outcome|QAB149 75 ug od|
732308|NCT01682863|O2|Outcome|QVA149 27.5/25 ug Bid|
732309|NCT01682863|O1|Outcome|QVA149 27.5/12.5 ug Bid|
732310|NCT01682863|E3|Reported Event|QAB75|QVA149 27.5/25 μg capsules
732311|NCT01682863|E2|Reported Event|QVA149 27.5/25 ug Bid|
732312|NCT01682863|E1|Reported Event|QVA149 27.5/12.5 ug Bid|
732313|NCT01682837|B1|Baseline|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate powder, Potassium Citrate powder, Potassium Chloride powder, Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout.
732314|NCT01682837|P1|Participant Flow|All Study Participants|Participants received the following study drug in random order: Potassium Magnesium Citrate (KMgCit) powder, Potassium Citrate (KCit) powder, Potassium Chloride (KCl) powder and Placebo. Study medications were taken twice daily after dissolution in 250 ml water. Each phase was followed by at least 1 week of washout. Individual study drug assignments per randomization is provided in the comments for each study period.
732315|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732316|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732317|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732318|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732319|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732320|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732321|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732322|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732323|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732324|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732325|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732326|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732327|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732328|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732329|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732330|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732331|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732332|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732333|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732334|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732335|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732336|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732337|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732338|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732340|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732341|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732342|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732343|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732344|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732345|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732346|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732347|NCT01682837|O4|Outcome|Placebo Phase|Participants undergoing the Placebo phase of the study.
732348|NCT01682837|O3|Outcome|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732349|NCT01682837|O2|Outcome|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732350|NCT01682837|O1|Outcome|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732351|NCT01682837|E4|Reported Event|Placebo Phase|Participants undergoing the Placebo phase of the study.
732352|NCT01682837|E3|Reported Event|Potassium Chloride Powder Phase|Participants undergoing the Potassium Chloride powder phase of the study.
732353|NCT01682837|E2|Reported Event|Potassium Citrate Powder Phase|Participants undergoing the Potassium Citrate powder phase of the study.
732354|NCT01682837|E1|Reported Event|Potassium Magnesium Citrate Powder Phase|Participants undergoing the Potassium Magnesium Citrate powder phase of the study.
732355|NCT01682031|B3|Baseline|Total|Total of all reporting groups
732356|NCT01682031|B2|Baseline|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732357|NCT01682031|B1|Baseline|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732358|NCT01682031|P2|Participant Flow|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732359|NCT01682031|P1|Participant Flow|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732360|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732386|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732387|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732388|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732389|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732361|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732362|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732363|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732364|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732365|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732366|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732367|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732368|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732369|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732370|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732371|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732372|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732373|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732374|NCT01682031|O2|Outcome|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732375|NCT01682031|O1|Outcome|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732376|NCT01682031|E2|Reported Event|Arm II (Selenomethionine, Cisplatin, and Radiotherapy)|"Patients receive selenomethionine PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin and undergo radiotherapy as in arm I.~selenomethionine: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732377|NCT01682031|E1|Reported Event|Arm I (Placebo, Cisplatin, and Radiotherapy)|"Patients receive placebo PO twice daily in week 1 and then once daily in weeks 2-11. Patients also receive cisplatin IV over 3 hours once in weeks 2, 5, and 8 and undergo radiotherapy 5 days a week in weeks 2-8.~placebo: Given PO~cisplatin: Given IV~radiation therapy: Undergo radiotherapy~quality-of-life assessment: Ancillary studies"
732378|NCT01683838|B3|Baseline|Total|Total of all reporting groups
732379|NCT01683838|B2|Baseline|Placebo|Placebo : Placebo
732380|NCT01683838|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732381|NCT01683838|P2|Participant Flow|Placebo|Placebo : Placebo
732382|NCT01683838|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732383|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732384|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732385|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732390|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732391|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732392|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732393|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732394|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732395|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732396|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732397|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732398|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732399|NCT01683838|O2|Outcome|Placebo|Placebo : Placebo
732400|NCT01683838|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732401|NCT01683838|E2|Reported Event|Placebo|Placebo : Placebo
732402|NCT01683838|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
732403|NCT01683812|B1|Baseline|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
732404|NCT01683812|P1|Participant Flow|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
732405|NCT01683812|O1|Outcome|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
732406|NCT01683812|O1|Outcome|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
732407|NCT01683812|E1|Reported Event|Cranial Cup Arm|"Single arm~Cranial Cup: Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day."
732408|NCT01683630|B3|Baseline|Total|Total of all reporting groups
732409|NCT01683630|B2|Baseline|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
732410|NCT01683630|B1|Baseline|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
732411|NCT01683630|P2|Participant Flow|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
732412|NCT01683630|P1|Participant Flow|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
732413|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
732414|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
732415|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
732416|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
732417|NCT01683630|O2|Outcome|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
732418|NCT01683630|O1|Outcome|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
732419|NCT01683630|E2|Reported Event|Confirmed Cases of Influenza B|Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
732420|NCT01683630|E1|Reported Event|Confirmed Cases of Influenza A|Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
732421|NCT01683604|B1|Baseline|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732422|NCT01683604|P1|Participant Flow|Rheumatoid Arthritis (RA) Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732423|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732424|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732425|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732426|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732427|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732428|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732429|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732430|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732431|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732432|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732433|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732434|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732435|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732436|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732437|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732438|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732439|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732440|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732441|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732442|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732443|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732444|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732445|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732446|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732447|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732448|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732449|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732450|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732451|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732452|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732453|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732454|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732455|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732456|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732457|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732458|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732459|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732460|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732461|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732462|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732463|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732464|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732465|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732466|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732467|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732468|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732469|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732470|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732471|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732472|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732473|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732474|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732475|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732476|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732477|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732478|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732479|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732480|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732481|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732482|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732483|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732484|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732485|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732486|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732487|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732488|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732489|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732490|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732491|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732492|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732493|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732494|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732495|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732496|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732497|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732498|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732499|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732500|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732501|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732502|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732503|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732504|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732505|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732506|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732507|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732508|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732509|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732510|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732511|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732512|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732513|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732514|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732515|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732516|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732517|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732518|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732519|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732520|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732521|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732522|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732523|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732524|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732525|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732526|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732527|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732528|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732529|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732530|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732531|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732532|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732533|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732534|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732535|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732536|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732537|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732538|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732539|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732540|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732541|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732542|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732543|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732544|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732545|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732546|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732547|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732548|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732549|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732550|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732551|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732552|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732553|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732554|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732555|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732556|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732591|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732557|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732558|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732559|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732560|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732561|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732562|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732563|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732564|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732565|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732566|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732567|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732568|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732569|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732570|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732571|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732572|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732573|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732574|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with DMARD at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732575|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732576|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732577|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732578|NCT01683604|O5|Outcome|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732579|NCT01683604|O4|Outcome|RA Participants (Combination Therapy Group)|Participants with severe RA, were prescribed with disease-modifying anti-rheumatic drug (DMARD) at the time of first dose of tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732580|NCT01683604|O3|Outcome|RA Participants (Monotherapy Group)|Participants with severe RA, were prescribed with tocilizumab alone, in accordance with routine clinic practice and were observed for 6 months.
732581|NCT01683604|O2|Outcome|RA Participants (Biologic Exposed Group)|Participants with severe RA, with prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732582|NCT01683604|O1|Outcome|RA Participants (Biologic Naïve Group)|Participants with severe RA, and no prior exposure to biologic agent were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732583|NCT01683604|E1|Reported Event|RA Participants (All Groups)|Participants with severe RA were prescribed with tocilizumab, in accordance with routine clinic practice and were observed for 6 months.
732584|NCT01683526|B3|Baseline|Total|Total of all reporting groups
732585|NCT01683526|B2|Baseline|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732586|NCT01683526|B1|Baseline|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732587|NCT01683526|P2|Participant Flow|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732588|NCT01683526|P1|Participant Flow|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732589|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732590|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732592|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732593|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732594|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732595|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732596|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732597|NCT01683526|O2|Outcome|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732598|NCT01683526|O1|Outcome|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732599|NCT01683526|E2|Reported Event|Video Laryngoscopy|"Intubation will be done using video laryngoscopy~Video laryngoscopy (Glidescope)"
732600|NCT01683526|E1|Reported Event|Direct Laryngoscopy|"Intubation will be done using direct laryngoscopy~Direct laryngoscopy"
732601|NCT01683383|B3|Baseline|Total|Total of all reporting groups
732602|NCT01683383|B2|Baseline|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
732603|NCT01683383|B1|Baseline|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
732604|NCT01683383|P2|Participant Flow|Device (Servo-regulated Cooling)|Infants were placed on a servo-controlled cooling blanket after a rectal or esophageal probe was inserted. The temperature was servo-controlled using the Tecotherm Neo (Inspiration Medical LTD, Leicester, UK) (Appendix 1; online only) with the target temperature set to 33.5°C.
732605|NCT01683383|P1|Participant Flow|Control (Standard Cooling)|Infants were cooled as per the birth hospital practice either passively (turning the radiant warmer /incubator off) and/or actively (ice or gel packs).
732646|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732606|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
732607|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
732608|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
732609|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
732610|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
732611|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
732612|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
732613|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
732614|NCT01683383|O2|Outcome|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
732615|NCT01683383|O1|Outcome|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
732616|NCT01683383|E2|Reported Event|Device (Servo-regulated Cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
732617|NCT01683383|E1|Reported Event|Control (Standard Cooling)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
732618|NCT01683266|B3|Baseline|Total|Total of all reporting groups
732619|NCT01683266|B2|Baseline|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732620|NCT01683266|B1|Baseline|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732621|NCT01683266|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
732622|NCT01683266|P1|Participant Flow|HOE901­-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning or evening for 12 months on top of mealtime insulin analogue.
732623|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732624|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732625|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732626|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732627|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732628|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732629|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732630|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732631|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732632|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732633|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732634|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732635|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732636|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732637|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732638|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732639|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732640|NCT01683266|O1|Outcome|HOE901­-U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732641|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732642|NCT01683266|O1|Outcome|HOE901-­U300|HOE901­U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732643|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732644|NCT01683266|O1|Outcome|HOE901­-U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732645|NCT01683266|O2|Outcome|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732647|NCT01683266|E2|Reported Event|Lantus|Lantus SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732648|NCT01683266|E1|Reported Event|HOE901-­U300|HOE901-U300 SC injection once daily in morning or evening for 12 months on top of mealtime insulin.
732649|NCT01683058|B1|Baseline|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732650|NCT01683058|P1|Participant Flow|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732651|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732652|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732653|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732654|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732655|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732656|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732657|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732658|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732659|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732660|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732661|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732662|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732663|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732664|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732665|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732666|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732667|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732668|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732669|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732670|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/ 300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732671|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732672|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732673|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732674|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732675|NCT01683058|O1|Outcome|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732676|NCT01683058|E1|Reported Event|Aripiprazole IM Depot 400/300 mg|All participants in this trial received aripiprazole IM depot 400/300 mg every 4 weeks for over 24 weeks.
732677|NCT01683019|B4|Baseline|Total|Total of all reporting groups
732678|NCT01683019|B3|Baseline|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
732679|NCT01683019|B2|Baseline|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732680|NCT01683019|B1|Baseline|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732681|NCT01683019|P3|Participant Flow|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
732682|NCT01683019|P2|Participant Flow|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732716|NCT01682720|B2|Baseline|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
732683|NCT01683019|P1|Participant Flow|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732684|NCT01683019|O3|Outcome|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
732685|NCT01683019|O2|Outcome|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732686|NCT01683019|O1|Outcome|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732687|NCT01683019|E3|Reported Event|Inactive Sham Treatment|"Generate sound similar to active treatment, except that no magnetic field is generated.~Sham NeoSync EEG Synchronization Therapy : A device that looks and sounds similar to the active treatment, but no magnetic field is generated."
732688|NCT01683019|E2|Reported Event|Active Random Frequency Magnetic Stimulation|"Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second.~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732689|NCT01683019|E1|Reported Event|Active Fixed Alpha Frequency Magnetic Stimulation|"Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF).~NeoSync EEG Synchronization Therapy : Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks."
732690|NCT01682759|B3|Baseline|Total|Total of all reporting groups
732691|NCT01682759|B2|Baseline|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732692|NCT01682759|B1|Baseline|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732693|NCT01682759|P2|Participant Flow|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732694|NCT01682759|P1|Participant Flow|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732695|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732696|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732697|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732698|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732699|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732700|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732701|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732702|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732703|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732704|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732705|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732706|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732707|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732708|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732709|NCT01682759|O2|Outcome|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732710|NCT01682759|O1|Outcome|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732711|NCT01682759|E2|Reported Event|Glimepiride|Participants will receive glimepiride titrated to a maximum of 6 mg, once daily, and placebo to omarigliptin, once weekly for up to 54 weeks.
732712|NCT01682759|E1|Reported Event|Omarigliptin|Participants will receive omarigliptin, 25 mg once weekly and placebo matching glimepiride once daily for up to 54 weeks.
732713|NCT01682720|B5|Baseline|Total|Total of all reporting groups
732714|NCT01682720|B4|Baseline|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
732715|NCT01682720|B3|Baseline|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
732717|NCT01682720|B1|Baseline|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + placebo to match RBV for 12 weeks in participants with genotype 2 or 3 HCV infection.
732718|NCT01682720|P4|Participant Flow|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
732719|NCT01682720|P3|Participant Flow|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
732720|NCT01682720|P2|Participant Flow|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
732721|NCT01682720|P1|Participant Flow|Placebo 12 Weeks (GT2/3)|Placebo to match sofosbuvir (SOF) + placebo to match ribavirin (RBV) for 12 weeks in participants with genotype (GT)2 or 3 HCV infection.
732722|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
732723|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
732724|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
732725|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
732726|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
732727|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
732728|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
732729|NCT01682720|O2|Outcome|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
732730|NCT01682720|O1|Outcome|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
732731|NCT01682720|O3|Outcome|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
732732|NCT01682720|O2|Outcome|SOF 12 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 3 HCV infection.
732733|NCT01682720|O1|Outcome|SOF 12 Weeks (GT2)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 HCV infection.
732734|NCT01682720|E3|Reported Event|SOF 24 Weeks (GT3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 24 weeks in participants with genotype 3 HCV infection.
732735|NCT01682720|E2|Reported Event|SOF 12 Weeks (GT2/3)|SOF 400 mg tablet once daily + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
732736|NCT01682720|E1|Reported Event|Placebo 12 Weeks (GT2/3)|Placebo to match SOF + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks in participants with genotype 2 or 3 HCV infection.
732737|NCT01682681|B1|Baseline|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732782|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
732738|NCT01682681|P1|Participant Flow|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732739|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732740|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732741|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732742|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732743|NCT01682681|O1|Outcome|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732744|NCT01682681|E1|Reported Event|Topiramate|This was an observational study. Participants with seizures received topiramate as per Investigator’s discretion were observed.
732745|NCT01682642|B3|Baseline|Total|Total of all reporting groups
732746|NCT01682642|B2|Baseline|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
732747|NCT01682642|B1|Baseline|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
732748|NCT01682642|P2|Participant Flow|Vaporization Only|After surgical vaporization of the endometriosis , patients start immediately with IVF treatment (without additional treatment).
732749|NCT01682642|P1|Participant Flow|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months immediately following the start of IVF treatment.
732750|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
732751|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following ivf treatment.
732752|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
732753|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start IVF treatment.
732754|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients immediately start IVF without additional treatment.
732755|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVFtreatment.
732756|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
732757|NCT01682642|O1|Outcome|Zoladex|
732758|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
732759|NCT01682642|O1|Outcome|Zoladex|After surgical vaporization of endometriosis, patients are treated with Zoladex for 3 months and immediately following start of IVF treatment.
732760|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
732761|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
732762|NCT01682642|O2|Outcome|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
732763|NCT01682642|O1|Outcome|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
732764|NCT01682642|E2|Reported Event|Vaporization Only|Surgical vaporization of the endometriosis is done and patients start IVF without additional treatment.
732765|NCT01682642|E1|Reported Event|Zoladex|"After surgical vaporization of endometriosis patients are treated with Zoladex for 3 months.~Zoladex: after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment"
732766|NCT01682603|B1|Baseline|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732767|NCT01682603|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A (BoNT-A) (BOTOX 300U)
732768|NCT01682603|O2|Outcome|Pre-Non Autonomic Dysreflexia|Baseline Non autonomic dysreflexia
732769|NCT01682603|O1|Outcome|Pre-Autonomic Dysreflexia|Baseline Autonomic dysreflexia
732770|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732771|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732772|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732773|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732774|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732775|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732776|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732777|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732778|NCT01682603|O1|Outcome|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732779|NCT01682603|E1|Reported Event|Botulinum Toxin A|"BoNT-A (BOTOX 300U)~Botulinum toxin A: BoNT-A (BOTOX 300U)"
732780|NCT01682538|B1|Baseline|Overall Study|All treatment arms
732781|NCT01682538|P1|Participant Flow|All Treatment Groups|"All participants received all study treatments in a randomized fashion. Subjects were allocated to one of the following treatment sequences (2 subjects to each sequence):~A B C; B C A; C A B; C B A; A C B; B A C where A=Orfadin capsules, single dose, 30 mg; B=Orfadin suspension, single dose 30 mg, fasting; C=Orfadin suspension, single dose 30 mg, fed"
732884|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
732783|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
732784|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732785|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
732786|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension, 4 mg/mL, single dose, 30 mg (7.5 mL)
732787|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732788|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
732789|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
732790|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732791|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
732792|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
732793|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732794|NCT01682538|O3|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
732795|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
732796|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732797|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
732798|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
732799|NCT01682538|O2|Outcome|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
732800|NCT01682538|O1|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose 30 mg (7,5 mL)
732801|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
732802|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732803|NCT01682538|O2|Outcome|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7,5 mL)
732804|NCT01682538|O1|Outcome|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732805|NCT01682538|E3|Reported Event|Orfadin Suspension, With Food|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
732806|NCT01682538|E2|Reported Event|Orfadin Suspension, Fasting|Orfadin suspension 4 mg/mL, single dose, 30 mg (7.5 mL)
732807|NCT01682538|E1|Reported Event|Orfadin Capsules, Fasting|Orfadin capsules, single dose, 30 mg
732808|NCT01682460|B1|Baseline|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732809|NCT01682460|P1|Participant Flow|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732810|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732811|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732812|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732813|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732814|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732815|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732816|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732817|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732818|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732819|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732820|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732821|NCT01682460|O1|Outcome|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732822|NCT01682460|E1|Reported Event|Refresh Tears Lubricant Eye Drops (Allergan)|"Artificial tears eye drops QID for 1 month~Refresh Tears Lubricant Eye Drops (Allergan): Eye drops QID for 1 month"
732823|NCT01682135|B4|Baseline|Total|Total of all reporting groups
732824|NCT01682135|B3|Baseline|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732825|NCT01682135|B2|Baseline|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 3. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732826|NCT01682135|B1|Baseline|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle) followed by dose escalation to Cohort 2. When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732827|NCT01682135|P3|Participant Flow|Cohort 3 - 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
732828|NCT01682135|P2|Participant Flow|Cohort 2 - 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
732829|NCT01682135|P1|Participant Flow|Cohort 1 - 6 mg/kg/2w Ramucirumab|6 milligram per kilogram (mg/kg) ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2. After Cycle 1 treatment, participants who had an objective response or stable disease were permitted to receive ramucirumab at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met.
732830|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732831|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732832|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732833|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732834|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732835|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732836|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732837|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732838|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732839|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732840|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732841|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732842|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732843|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732844|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732845|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732846|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732847|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732848|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732849|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732850|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732851|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732852|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732853|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732854|NCT01682135|O3|Outcome|Cohort 3: 8 mg/kg/2w Ramucirumab|8 mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732855|NCT01682135|O2|Outcome|Cohort 2: 10 mg/kg/3w Ramucirumab|10 mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732856|NCT01682135|O1|Outcome|Cohort 1: 6 mg/kg/2w Ramucirumab|6 mg/kg ramucirumab administered intravenously (IV) every 2 weeks (w) for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732857|NCT01682135|E3|Reported Event|Cohort 3 - 8mg/kg/2w Ramucirumab|8mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle).
732858|NCT01682135|E2|Reported Event|Cohort 2 - 10mg/kg/3w Ramucirumab|10mg/kg ramucirumab administered IV every 3 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 3.
732859|NCT01682135|E1|Reported Event|Cohort 1 - 6mg/kg/2w Ramucirumab|6mg/kg ramucirumab administered IV every 2 weeks for 6 weeks (one cycle). When a pre-defined percentage of participants completed Cycle 1 without experiencing a DLT, dose escalation was initiated with the start of Cohort 2.
732860|NCT01681628|B3|Baseline|Total|Total of all reporting groups
732861|NCT01681628|B2|Baseline|Wait List|"Delayed intervention.~No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 mo the later."
732862|NCT01681628|B1|Baseline|Thought Field Therapy (TFT)|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 months later"
732863|NCT01681628|P2|Participant Flow|Wait List|"Delayed intervention.~No intervention prior to assessment after one week (pre-test 2). Then treated with Thought Field Therapy, and re-assessed after a further week (post-test).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732928|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732864|NCT01681628|P1|Participant Flow|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732865|NCT01681628|O1|Outcome|Wait List Group|Those in the wait list, who had attended for their second immediate pre-treatment assessment and attended for assessment 19 months later.
732866|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732867|NCT01681628|O3|Outcome|Wait List: Thought Field Therapy|After two control assessments at times 1 and 2, the wait list group were treated and re-assessed one week later at time 3. Non-attenders at time 3 were excluded from analysis.
732868|NCT01681628|O2|Outcome|Wait List no Treatment|"No intervention prior to assessment after one week (pre-test 2).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732869|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732870|NCT01681628|O3|Outcome|Wait-list: Thought Field Therapy|"Received thought field therapy after second assessment (time 2) and re-assessed one week later (time 3).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732871|NCT01681628|O2|Outcome|Wait List: no Therapy|"No thought field therapy intervention prior to assessment after one week (pre-test 2).~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732872|NCT01681628|O1|Outcome|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress."
732873|NCT01681628|E1|Reported Event|Thought Field Therapy|"Thought Field Therapy delivered by trained community leaders.~Thought Field Therapy.: Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.~Both groups were invited to attend 19 months later"
732874|NCT01681576|B3|Baseline|Total|Total of all reporting groups
732875|NCT01681576|B2|Baseline|Valsartan 320mg|Period 1: 4 weeks treatment with Valsartan 320mg QD, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696 400mg QD
732876|NCT01681576|B1|Baseline|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
732877|NCT01681576|P2|Participant Flow|Valsartan Followed by LCZ696|Period 1: Valsartan 320mg QD for 4 weeks then washout followed by Period 2: LCZ696 400mg QD for 4 weeks
732878|NCT01681576|P1|Participant Flow|LCZ696 Followed by Valsartan|Period 1: LCZ696 400mg QD for 4 weeks then washout followed by Period 2: Valsartan 320mg QD for 4 weeks
732879|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
732880|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
732881|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
732882|NCT01681576|O1|Outcome|LCZ696 - ALL|LCZ696 400mg
732883|NCT01681576|O2|Outcome|Valsartan - ALL|Valsartan 320mg QD
732889|NCT01681576|E2|Reported Event|Valsartan 320 mg QD|Valsartan 320 mg QD
732890|NCT01681576|E1|Reported Event|LCZ696 400 mg QD|LCZ696 400 mg QD
732891|NCT01681511|B3|Baseline|Total|Total of all reporting groups
732892|NCT01681511|B2|Baseline|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732893|NCT01681511|B1|Baseline|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732894|NCT01681511|P2|Participant Flow|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732895|NCT01681511|P1|Participant Flow|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732929|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732930|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732896|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732897|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732898|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732899|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732900|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732901|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732902|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732903|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732904|NCT01681511|O2|Outcome|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732905|NCT01681511|O1|Outcome|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732906|NCT01681511|E2|Reported Event|ICET™ TIC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~ICET™ TIC Foley Catheter : The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting."
732907|NCT01681511|E1|Reported Event|BARD® LUBRI-SIL® IC Foley Catheter|"Route of Administration: Urinary Bladder Catheterization~BARD® LUBRI-SIL® IC Foley Catheter : The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel."
732908|NCT01681472|B5|Baseline|Total|Total of all reporting groups
732909|NCT01681472|B4|Baseline|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732910|NCT01681472|B3|Baseline|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732911|NCT01681472|B2|Baseline|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
732912|NCT01681472|B1|Baseline|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
732913|NCT01681472|P4|Participant Flow|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732914|NCT01681472|P3|Participant Flow|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732915|NCT01681472|P2|Participant Flow|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
732916|NCT01681472|P1|Participant Flow|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
732917|NCT01681472|O4|Outcome|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732918|NCT01681472|O3|Outcome|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732919|NCT01681472|O2|Outcome|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
732920|NCT01681472|O1|Outcome|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
732921|NCT01681472|E4|Reported Event|6R-MTHF 60 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732922|NCT01681472|E3|Reported Event|6R-MTHF 200 mg/m2|[6R] 5,10-methylenetetrahydrofolate: i.v. bolus injection
732923|NCT01681472|E2|Reported Event|Levoleucovorin 60 mg/m2|Levoleucovorin: i.v. bolus injection
732924|NCT01681472|E1|Reported Event|Levoleucovorin 200 mg/m2|Levoleucovorin: i.v. bolus injection
732925|NCT01681368|B1|Baseline|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732926|NCT01681368|P1|Participant Flow|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732927|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732931|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732932|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732933|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732934|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732935|NCT01681368|O1|Outcome|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732936|NCT01681368|E1|Reported Event|Birinapant for Advanced Ovarian,Fallopian Tube & Peritoneal Ca|"single arm~Birinapant (TL32711): 47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle"
732937|NCT01681277|B6|Baseline|Total|Total of all reporting groups
732938|NCT01681277|B5|Baseline|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732939|NCT01681277|B4|Baseline|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732940|NCT01681277|B3|Baseline|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732941|NCT01681277|B2|Baseline|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732942|NCT01681277|B1|Baseline|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
732943|NCT01681277|P5|Participant Flow|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732944|NCT01681277|P4|Participant Flow|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732945|NCT01681277|P3|Participant Flow|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732946|NCT01681277|P2|Participant Flow|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
733744|NCT01677182|P3|Participant Flow|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
732947|NCT01681277|P1|Participant Flow|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
732948|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732949|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732950|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732951|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732952|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732953|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732954|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732955|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732956|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732957|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732958|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732959|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732960|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732961|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732962|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732963|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732964|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
733745|NCT01677182|P2|Participant Flow|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
732965|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732966|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732967|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732968|NCT01681277|O4|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732969|NCT01681277|O3|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732970|NCT01681277|O2|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732971|NCT01681277|O1|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732972|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732973|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732974|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732975|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732976|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
732977|NCT01681277|O5|Outcome|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732978|NCT01681277|O4|Outcome|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732979|NCT01681277|O3|Outcome|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732980|NCT01681277|O2|Outcome|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732981|NCT01681277|O1|Outcome|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
732982|NCT01681277|E5|Reported Event|BI 113608 100 mg qd (DG4)|DG 4: Subjects were orally administered with daily dose of BI 113608 100 mg (100 mg q.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 to Day 14.
732983|NCT01681277|E4|Reported Event|BI 113608 100 mg Bid (DG3)|DG 3: Subjects were orally administered with daily dose of BI 113608 200 mg (100 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732984|NCT01681277|E3|Reported Event|BI 113608 50 mg Bid (DG2)|DG 2: Subjects were orally administered with daily dose of BI 113608 100 mg (50 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732985|NCT01681277|E2|Reported Event|BI 113608 25 mg Bid (DG1)|Dose Group (DG) 1: Subjects were orally administered with daily dose of BI 113608 50 mg (25 mg b.i.d) (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1, followed by a 12-days (b.i.d. treatment on Days 2 to 13, and a single morning dose on Day 14.
732986|NCT01681277|E1|Reported Event|Placebo|Subjects were orally administered matching placebo to BI 113608 (powder in the bottle for oral solution) with 240 ml water after an overnight fast of at least 10 h. Subjects were treated for 14 days. Each subject received a single morning dose on Day 1 and Day 14 for all dose group, twice daily dose (b.i.d.) on Days 2 to 13 for dose group 1 to 3 and a single morning dose (q.d.) for group 4.
732987|NCT01681212|B1|Baseline|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
732988|NCT01681212|P1|Participant Flow|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression, unacceptable toxicity, or withdrawal of consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
732989|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
732990|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
732991|NCT01681212|O1|Outcome|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
732992|NCT01681212|E1|Reported Event|Ipilimumab, 10 mg/kg + Dacarbazine, 850 mg/m^2|During the Induction Period, participants received ipilimumab, 10 mg/kg, as tolerated by intravenous (IV) infusion as 1 single dose during Weeks 1 (Day 1), 4, 7, and 10 for a total of 4 separate doses. During the Maintenance Phase, participants received ipilimumab, 10 mg/kg, as tolerated by IV infusion every 12 weeks, beginning at Week 24, until disease progression or unacceptable toxicity occurred or the patient withdrew consent. Participants also received dacarbazine, 850 mg/m^2, by IV infusion over 30 to 60 minutes, starting on Week 1 and repeated every 3 weeks until Week 22. Dacarbazine was dosed on the same day as ipilimumab, when applicable, after the ipilimumab dose.
732993|NCT01681121|B3|Baseline|Total|Total of all reporting groups
732994|NCT01681121|B2|Baseline|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
732995|NCT01681121|B1|Baseline|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
732996|NCT01681121|P2|Participant Flow|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
732997|NCT01681121|P1|Participant Flow|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
732998|NCT01681121|O2|Outcome|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
732999|NCT01681121|O1|Outcome|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
733000|NCT01681121|E2|Reported Event|Placebo|"Placebo to match ADX-N05 to be taken once a day for 12 weeks~Placebo: One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks"
733001|NCT01681121|E1|Reported Event|ADX-N05|"ADX-N05 to be taken once a day for 12 weeks~ADX-N05: 150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks"
733002|NCT01681095|B3|Baseline|Total|Total of all reporting groups
733003|NCT01681095|B2|Baseline|Custiodiol HTK|"55 participants were randomized to Custodiol HTK. Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733004|NCT01681095|B1|Baseline|Standard Cold Blood Cardioplegia|"55 participants were randomized to Standard cold blood cardioplegia. Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733058|NCT01680991|B2|Baseline|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733005|NCT01681095|P2|Participant Flow|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733006|NCT01681095|P1|Participant Flow|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733007|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733008|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733009|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733010|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733073|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733206|NCT01680458|E1|Reported Event|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733011|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733012|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733013|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733014|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733173|NCT01680549|B3|Baseline|Total|Total of all reporting groups
733015|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733016|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733017|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733018|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733019|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733020|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733021|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733022|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733023|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733024|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733025|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733026|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733027|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733028|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733029|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733030|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733207|NCT01680341|B3|Baseline|Total|Total of all reporting groups
733031|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733032|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733033|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733034|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733035|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733036|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733037|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733038|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733039|NCT01681095|O2|Outcome|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733040|NCT01681095|O1|Outcome|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733041|NCT01681095|E2|Reported Event|Cold Blood Cardioplegia|"Cold Blood Cardioplegia: One liter of cold blood cardioplegic solution, mixed at a ratio of 4:1 per Beaumont standard of care (blood /cardioplegic solution), contains the following in a 500 cc bag of D5W (dextrose 5% in water): 50meq/L potassium chloride, 37.5 meq/L sodium bicarbonate and 7.5 meq/L magnesium sulfate.~After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 8°C."
733042|NCT01681095|E1|Reported Event|Cardioplegia: Custodiol HTK Solution|"Custodiol HTK (histidine-tryptophan-ketoglutarate) cardioplegia: One liter of HTK solution (Custodiol; Koehler Chemi, Alsbach-Haenlien, Germany) contains the following components: 15 mmol/L sodium chloride, 9 mmol/L potassium chloride, 4 mmol/L magnesium chloride, 18 mmol/L histidine hydrochloride, 180 mmol/L histidine, 2 mmol/L tryptophan, 30 mmol/L mannitol, 0.015 mmol/L calcium chloride, 1 mmol/L potassium hydrogen 2-ketoglutarate, osmolarity 310 mOsm/kg, pH 7.02-7.20.~Custodiol-HTK was delivered to establish and maintain cardiac arrest. After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. Custodiol-HTK was delivered at a temperature of 4°C - 10°C."
733043|NCT01681069|B3|Baseline|Total|Total of all reporting groups
733044|NCT01681069|B2|Baseline|Placebo|"2 tablets twice a day~Placebo"
733045|NCT01681069|B1|Baseline|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
733046|NCT01681069|P2|Participant Flow|Placebo|"2 tablets twice a day~Placebo"
733047|NCT01681069|P1|Participant Flow|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
733048|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
733049|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
733050|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
733051|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
733052|NCT01681069|O2|Outcome|Placebo|"2 tablets twice a day~Placebo"
733053|NCT01681069|O1|Outcome|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
733054|NCT01681069|E2|Reported Event|Placebo|"2 tablets twice a day~Placebo"
733055|NCT01681069|E1|Reported Event|IQP-VV-102|"2 tablets twice a day~IQP-VV-102"
733056|NCT01680991|B4|Baseline|Total|Total of all reporting groups
733057|NCT01680991|B3|Baseline|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733059|NCT01680991|B1|Baseline|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733060|NCT01680991|P3|Participant Flow|FL: 1000 mg Obinutuzumab|Participants with follicular lymphoma (FL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733061|NCT01680991|P2|Participant Flow|DLBCL: 1000 mg Obinutuzumab|Participants with diffuse large B-cell lymphoma (DLBCL) received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733062|NCT01680991|P1|Participant Flow|CLL: 1000 mg Obinutuzumab|Participants with chronic lymphocytic leukemia (CLL) received 1000 milligrams (mg) obinutuzumab as an intravenous (IV) infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733063|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733064|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733065|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733066|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733067|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733068|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733069|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733070|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733071|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733072|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733074|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733075|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733076|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733077|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733078|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733079|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733080|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733081|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733082|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733083|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733084|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733085|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733086|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733087|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733088|NCT01680991|O2|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733089|NCT01680991|O1|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733090|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733091|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733092|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733093|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733094|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733095|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733096|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733097|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733123|NCT01680900|P2|Participant Flow|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733098|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733099|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733100|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733101|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733102|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733103|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733104|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733105|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733106|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733302|NCT01680159|E4|Reported Event|TA-650（Dose Escalation Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)
733107|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733108|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733109|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733110|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733111|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733112|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733113|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733114|NCT01680991|O3|Outcome|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733115|NCT01680991|O2|Outcome|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733116|NCT01680991|O1|Outcome|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733117|NCT01680991|E3|Reported Event|FL: 1000 mg Obinutuzumab|Participants with FL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733118|NCT01680991|E2|Reported Event|DLBCL: 1000 mg Obinutuzumab|Participants with DLBCL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15.
733119|NCT01680991|E1|Reported Event|CLL: 1000 mg Obinutuzumab|Participants with CLL received 1000 mg obinutuzumab as an IV infusion, on Day 1 of each 21-day cycle for a maximum of 8 cycles. Additional doses of obinutuzumab were administered on Cycle 1 Day 8 and Day 15. The first infusion on Cycle 1 Day 1 was given over two days: Day 1- 100 mg and Day 2- 900 mg.
733120|NCT01680900|B3|Baseline|Total|Total of all reporting groups
733121|NCT01680900|B2|Baseline|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733122|NCT01680900|B1|Baseline|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733124|NCT01680900|P1|Participant Flow|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733125|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733126|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733127|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733128|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733129|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733130|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733131|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733132|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733133|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733134|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733135|NCT01680900|O2|Outcome|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733136|NCT01680900|O1|Outcome|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733137|NCT01680900|E2|Reported Event|Placebo Capsules (Sugar Pill)|"Placebo capsules matched to the drug dose for 8 weeks~placebo capsules: placebo capsules matched to drug capsules."
733138|NCT01680900|E1|Reported Event|Experimental 1|"vilazodone (viibryd). 20 mg or 40 mg/day for 8 weeks~vilazodone: capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved."
733139|NCT01680861|B3|Baseline|Total|Total of all reporting groups
733140|NCT01680861|B2|Baseline|Tacrolimus/EC-MPS|our standard maintenance arm.
733141|NCT01680861|B1|Baseline|Tacrolimus/Everolimus|our experimental maintenance arm.
733142|NCT01680861|P2|Participant Flow|Tacrolimus/EC-MPS|our standard maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target EC-MPS dose: 720 mg PO BID (as tolerated).
733143|NCT01680861|P1|Participant Flow|Tacrolimus/Everolimus|our experimental maintenance arm: Target 12-hr Tacrolimus trough level: 5-8 ng/mL Target 12-hr Everolimus trough level: 3-8 ng/mL.
733144|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
733145|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
733146|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
733147|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
733148|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
733149|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
733150|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
733151|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
733152|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm
733153|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm
733154|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
733155|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
733156|NCT01680861|O2|Outcome|Tacrolimus/EC-MPS|our standard maintenance arm.
733157|NCT01680861|O1|Outcome|Tacrolimus/Everolimus|our experimental maintenance arm.
733158|NCT01680861|E2|Reported Event|Tacrolimus/EC-MPS|our standard maintenance arm
733159|NCT01680861|E1|Reported Event|Tacrolimus/Everolimus|our experimental maintenance arm
733160|NCT01680848|B1|Baseline|JDPBRN Dentists|"Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.~The JDPBRN aims to allow dentists to investigate research questions and share experiences and expertise and recruited its members from the JDPBRN website."
733161|NCT01680848|P1|Participant Flow|JDPBRN Dentists|Dentists working in outpatient dental practice (n=282) who were affiliated with the JDPBRN and who indicated that they do at least some restorative dentistry.
733162|NCT01680848|O1|Outcome|High Caries Risk|The proportion of dentists who indicated surgical intervention into enamel was 74% (N = 138) in the high-caries-risk scenario.
733163|NCT01680848|E1|Reported Event|This is an Observational Study|This is an observational study. We don't have two arms.
733164|NCT01680666|B3|Baseline|Total|Total of all reporting groups
733165|NCT01680666|B2|Baseline|Ultrasound Guided|All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
733166|NCT01680666|B1|Baseline|Landmark Guided|All patients between the ages of 0 and 18 years undergoing tunneled central venous line placement under general anesthesia were approached for inclusion in the study. Children known preoperatively to have non-patency of central veins or coagulopathy were excluded from the study. Patients with previous multiple line placements were screened for deep venous thrombosis using Doppler ultrasound. Patients were enrolled by a member of the study team, and informed consent for the study was obtained from the patient’s legal guardian.
733167|NCT01680666|P2|Participant Flow|Ultrasound Guided|In the ultrasound-guided group, the internal jugular vein on either side was accessed depending on surgeon’s preference. An ultrasound console with a linear 11 Hz probe was used. The patient was then put into Trendelenburg position. The head was positioned away from the insertion side. The ultrasound probe was placed at the apex of the triangle formed between the two heads of the sternocleidomastoid muscle and the clavicle. The internal jugular vein and common carotid artery were visualized, with the vein identified by its larger size, relative anatomic position, and compressibility. After a flashback of dark venous blood was noted in the syringe, the standard Seldinger technique was followed for the catheter insertion. After 3 failed attempts using the ultrasound at the specified site, the surgeon was free to further attempts using landmark or ultrasound approaches at any other site.
733168|NCT01680666|P1|Participant Flow|Landmark Guided|In the landmark technique, the subclavian vein or the internal jugular vein on either side was chosen for access depending on surgeon’s preference. An infraclavicular approach was used for the subclavian vein, and an anterior approach was used for the internal jugular vein. If venous flash could not be achieved after three attempts on the initial chosen site using the landmark technique, the study was terminated and the surgeon was free to use either ultrasound or landmark at any other site. A single pass of the needle was defined as a single episode of needle advancement and withdrawal. A second pass occurred if the needle was re-advanced or removed and reinserted. A failed attempt was recorded if aspiration resulted in no venous flash, arterial puncture (bright red blood, pulsatile flow), or air.
733169|NCT01680666|O2|Outcome|Ultrasound Guided|Success of central venous cannulation at first attempt
733170|NCT01680666|O1|Outcome|Landmark Technique|Success of central venous cannulation at first attempt
733171|NCT01680666|E2|Reported Event|Ultrasound|Success of central venous cannulation at first attempt
733172|NCT01680666|E1|Reported Event|Landmark|Success of central venous cannulation at first attempt
733174|NCT01680549|B2|Baseline|Placebo|"Placebo 600 mg po preoperatively and continued postoperatively 300 mg po q8hours X 3 days~Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
733175|NCT01680549|B1|Baseline|Gabapentin|"Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.~Gabapentin: Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days."
733176|NCT01680549|P2|Participant Flow|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
733177|NCT01680549|P1|Participant Flow|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
733178|NCT01680549|O2|Outcome|Gabapentin|Active pain control medicine
733179|NCT01680549|O1|Outcome|Placebo|Placebo comparator
733180|NCT01680549|O2|Outcome|Gabapentin|Active pain control Medicine
733181|NCT01680549|O1|Outcome|Placebo|Placebo- comparator
733182|NCT01680549|O2|Outcome|Placebo|Placebo 1 tab PO preoperatively and 1 tab PO continued postoperatively q8hours X 3 days
733183|NCT01680549|O1|Outcome|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
733184|NCT01680549|O2|Outcome|Gabapentin|Active pain medicine
733185|NCT01680549|O1|Outcome|Placebo|Placebo- Comparator
733186|NCT01680549|E2|Reported Event|Gabapentin|Active pain control medicine
733187|NCT01680549|E1|Reported Event|Placebo|placebo comparator
733188|NCT01680497|B1|Baseline|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733189|NCT01680497|P1|Participant Flow|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733190|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733191|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733192|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733193|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733194|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733195|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733196|NCT01680497|O1|Outcome|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733197|NCT01680497|E1|Reported Event|JUVÉDERM VOLIFT™|All subjects receiving treatment with JUVÉDERM VOLIFT™.
733198|NCT01680458|B1|Baseline|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733199|NCT01680458|P1|Participant Flow|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733200|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733201|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733202|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733203|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733204|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733205|NCT01680458|O1|Outcome|Fluconazole|Pediatric participants aged less than 7 years at the start of administration received fluconazole according to Japanese package insert.
733208|NCT01680341|B2|Baseline|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733209|NCT01680341|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733210|NCT01680341|P2|Participant Flow|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733211|NCT01680341|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733303|NCT01680159|E3|Reported Event|TA-650（Normal Dose Period）Psoriatic Arthritis|Psoriatic Arthritis
733212|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733213|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733214|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733215|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733216|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733217|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733218|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733219|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733287|NCT01680159|O4|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733220|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733221|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733222|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733223|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733239|NCT01680328|O8|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733224|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733225|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733226|NCT01680341|O2|Outcome|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733227|NCT01680341|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733228|NCT01680341|E2|Reported Event|IDegAsp Step Wise|IDegAsp was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) stepwise titration algorithm arm, self-titration was done once weekly based on the lowest of 3 pre-breakfast and 3 pre-dinner SMPG values (measurements on 3 consecutive days prior to titration).
733229|NCT01680341|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was injected subcutaneously (s.c.) in either abdomen, upper arm (deltoid area) or thigh. A pre-filled pen injector (PDS290) was used to administer IDegAsp. During treatment period subjects were allowed to continue up to 3 (oral antidiabetic drugs) OADs, except insulin glargine, sulphonylurea and glinides. In the IDegAsp twice daily (BID) simple titration algorithm arm, self-titration was performed twice weekly at intervals of 3-4 days and based upon a single pre-breakfast and pre-dinner self-measured plasma glucose (SMPG) value.
733230|NCT01680328|B1|Baseline|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
733256|NCT01680328|O9|Outcome|Injection Speed at 150 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733746|NCT01677182|P1|Participant Flow|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733231|NCT01680328|P1|Participant Flow|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
733232|NCT01680328|O7|Outcome|Injection Speed at 150 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733233|NCT01680328|O6|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733234|NCT01680328|O5|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733235|NCT01680328|O4|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733236|NCT01680328|O3|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733237|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733238|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
733240|NCT01680328|O7|Outcome|Injection Speed at 300 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733241|NCT01680328|O6|Outcome|Injection Speed at 450 μL/s|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733242|NCT01680328|O5|Outcome|Injection Volume 400 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733243|NCT01680328|O4|Outcome|Injection Volume 800 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733244|NCT01680328|O3|Outcome|Injection Volume 1200 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733245|NCT01680328|O2|Outcome|Injection Volume 1600 μL|Backflow (uL) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s), and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733246|NCT01680328|O1|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Backflow (uL) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
733247|NCT01680328|O2|Outcome|Abdomen|Acceptance of pain was assessed in each subject for all injections in the abdomen.
733248|NCT01680328|O1|Outcome|Thighs|Acceptance of pain was assessed in each subject for all injections in the thighs.
733249|NCT01680328|O3|Outcome|Injection Speed at 150 μL/s|Acceptance of pain was assessed in each subject for all injections.
733250|NCT01680328|O2|Outcome|Injection Speed at 300 μL/s|Acceptance of pain was assessed in each subject for all injections.
733251|NCT01680328|O1|Outcome|Injection Speed at 450 μL/s|Acceptance of pain was assessed in each subject for all injections.
733252|NCT01680328|O4|Outcome|Injection Volume of 400 μL|Acceptance of pain was assessed in each subject for all injections.
733253|NCT01680328|O3|Outcome|Injection Volume of 800 μL|Acceptance of pain was assessed in each subject for all injections.
733254|NCT01680328|O2|Outcome|Injection Volume of 1200 μL|Acceptance of pain was assessed in each subject for all injections.
733255|NCT01680328|O1|Outcome|Injection Volume of 1600 μL|Acceptance of pain was assessed in each subject for all injections.
733286|NCT01680159|O5|Outcome|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733257|NCT01680328|O8|Outcome|Injection Speed at 300 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733258|NCT01680328|O7|Outcome|Injection Speed at 450 μL/s|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733259|NCT01680328|O6|Outcome|Injection Volume 400 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733260|NCT01680328|O5|Outcome|Injection Volume 800 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733261|NCT01680328|O4|Outcome|Injection Volume 1200 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733262|NCT01680328|O3|Outcome|Injection Volume 1600 μL|Pain (VAS) was assessed in the abdomen following administration of 4 different injection volumes (400, 800, 1200 and 1600 µL) at 3 different injection speeds (150, 300 and 450 µL/s); and in the thighs following administration of the selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450).
733263|NCT01680328|O2|Outcome|Abdomen: Injection Region-12 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 12 s.c injections+1 needle insertion administered in the abdomen.
733264|NCT01680328|O1|Outcome|Thighs: Injection Region-5 s.c Injections+1 Needle Insertion|Pain (VAS) was assessed in each subject for the 5 s.c injections+1 needle insertion administered in the thighs.
733300|NCT01680159|E6|Reported Event|TA-650（Dose Escalation Period）Psoriatic Arthritis|Psoriatic Arthritis
733301|NCT01680159|E5|Reported Event|TA-650（Dose Escalation Period）Plaque Psoriasis|Plaque Psoriasis
733265|NCT01680328|E1|Reported Event|All Participants|Subjects received 19 subcutaneous (s.c) injections. Of the 19 injections, 13 were in the abdomen and 6 in the thighs. Of the 13 injections in the abdomen, 1 was a needle insertion and 12 were combinations of the 4 different injection volumes (400, 800, 1200 and 1600 µL) and 3 injection speeds (150, 300 and 450 µL/s). Of the 6 injections in the thigh, 1 was a needle insertion and 5 were selected combinations of injection volume (µL) and speed (µL/s) (400/150, 400/450, 800/300, 1600/150, 1600/450). Except for the 2 needle insertions, sodium chloride 0.9% solution was injected.
733266|NCT01680172|B3|Baseline|Total|Total of all reporting groups
733267|NCT01680172|B2|Baseline|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
733268|NCT01680172|B1|Baseline|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
733269|NCT01680172|P2|Participant Flow|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
733270|NCT01680172|P1|Participant Flow|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
733271|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
733272|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
733273|NCT01680172|O2|Outcome|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
733274|NCT01680172|O1|Outcome|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
733275|NCT01680172|E2|Reported Event|Placebo|"Single dose of placebo~Placebo: Single dose of placebo"
733276|NCT01680172|E1|Reported Event|Ketamine|"Single dose of ketamine (0.5 mg/kg)~Ketamine: Single dose of ketamine (0.5 mg/kg)"
733277|NCT01680159|B5|Baseline|Total|Total of all reporting groups
733278|NCT01680159|B4|Baseline|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733279|NCT01680159|B3|Baseline|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733280|NCT01680159|B2|Baseline|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733281|NCT01680159|B1|Baseline|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733282|NCT01680159|P1|Participant Flow|TA-650|During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either “efficacy attenuated” or “efficacy maintained” at week 8 of the normal dose period).
733283|NCT01680159|O1|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733284|NCT01680159|O1|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733285|NCT01680159|O1|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733288|NCT01680159|O3|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733289|NCT01680159|O2|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733290|NCT01680159|O1|Outcome|Overall|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733291|NCT01680159|O5|Outcome|Psoriatic Erythroderma|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733292|NCT01680159|O4|Outcome|Pustular Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733293|NCT01680159|O3|Outcome|Psoriatic Arthritis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733294|NCT01680159|O2|Outcome|Plaque Psoriasis|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733295|NCT01680159|O1|Outcome|Overall|From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
733296|NCT01680159|E10|Reported Event|TA-650（Entire Evaluation Period）Psoriatic Arthritis|Psoriatic Arthritis
733297|NCT01680159|E9|Reported Event|TA-650（Entire Evaluation Period）Plaque Psoriasis|Plaque Psoriasis
733298|NCT01680159|E8|Reported Event|TA-650（Dose Escalation Period）Psoriatic Erythroderma|Psoriatic Erythroderma
733299|NCT01680159|E7|Reported Event|TA-650（Dose Escalation Period）Pustular Psoriasis|Pustular Psoriasis
733305|NCT01680159|E1|Reported Event|TA-650（Normal Dose Period）Overall|Overall(Plaque Psoriasis・Psoriatic Arthritis)
733306|NCT01680016|B3|Baseline|Total|Total of all reporting groups
733307|NCT01680016|B2|Baseline|Essen|Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733308|NCT01680016|B1|Baseline|Zagreb|Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733309|NCT01680016|P4|Participant Flow|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733310|NCT01680016|P3|Participant Flow|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733311|NCT01680016|P2|Participant Flow|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733312|NCT01680016|P1|Participant Flow|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
733313|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733314|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733315|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733316|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
733317|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733318|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733319|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733320|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733321|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733322|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733323|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733324|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733325|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733326|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733327|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733328|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733329|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733330|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733331|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733332|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733333|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733334|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733335|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733336|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733337|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733338|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733339|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733340|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733341|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733342|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733343|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733344|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733345|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733766|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733346|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733347|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733348|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733349|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733350|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733351|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733352|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733353|NCT01680016|O6|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733354|NCT01680016|O5|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733355|NCT01680016|O4|Outcome|Essen(≥61 Years)|≥61 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733356|NCT01680016|O3|Outcome|Zagreb(≥61 Years)|≥61 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733357|NCT01680016|O2|Outcome|Essen(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733358|NCT01680016|O1|Outcome|Zagreb(≥51 to ≤60 Years)|≥51 to ≤60 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733359|NCT01680016|O6|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733360|NCT01680016|O5|Outcome|Zagreb( ≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733361|NCT01680016|O4|Outcome|Essen(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733362|NCT01680016|O3|Outcome|Zagreb(≥12 to ≤17 Years)|≥12 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733363|NCT01680016|O2|Outcome|Essen(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733364|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤11 Years)|≥6 to ≤11 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733365|NCT01680016|O2|Outcome|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733366|NCT01680016|O1|Outcome|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
733367|NCT01680016|O2|Outcome|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
733368|NCT01680016|O1|Outcome|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1, 8 and 22
733369|NCT01680016|E4|Reported Event|Essen(≥51 Years)|≥51 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
733370|NCT01680016|E3|Reported Event|Zagreb(≥51 Years)|≥51 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733371|NCT01680016|E2|Reported Event|Essen(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Essen schedule (1-1-1-1-1) i.e. 5 doses of Rabipur at days 1, 4, 8, 15 and 29
733372|NCT01680016|E1|Reported Event|Zagreb(≥6 to ≤17 Years)|≥6 to ≤17 years-old subjects received Zagreb schedule (2-1-1) i.e. 4 doses of Rabipur at days 1 , 8 and 22
733373|NCT01679613|B1|Baseline|Overall Study|This was a randomised, open-label trial in healthy male subjects with a 2-way cross-over Pilot part, followed by a 2-way cross-over Main part. Subjects participated either in the Pilot part with 2 treatments (A and B) given in 1 of the 2 treatment sequences (A_B and B_A) or in the Main part with also 2 treatments (C and D) given in 1 of the 2 treatment sequences (C_D and D_C). Nintedanib administrations of the 2 respective treatments (A and B or C and D) were to be separated by a wash-out period of at least 14 days. The Pilot part was separated from the Main part by at least 3 weeks to allow for interim analysis
733374|NCT01679613|P4|Participant Flow|Nintedanib+Ketoconazole (Main Part)/ Nintedanib (Main Part)|Ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose, based on the results from the Pilot part (Treatment C).
733375|NCT01679613|P3|Participant Flow|Nintedanib (Main Part)/ Nintedanib+Ketoconazole (Main Part)|Based on the results from the Pilot part, nintedanib 50mg was given as a single dose (Treatment C). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for 3 days followed by administration of nintedanib 50mg as a single dose 1h after administration of ketoconazole, based on the results from the Pilot part. Nintedanib administration was done under steady state ketoconazole (Treatment D)
733376|NCT01679613|P2|Participant Flow|Nintedanib+Ketoconazole (Pilot Part)/ Nintedanib (Pilot Part)|Ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B). Following a wash out period of at least 14 days, nintedanib 50mg was given as a single dose (Treatment A).
733403|NCT01679314|O2|Outcome|Sham AlphaCore Device|"Sham AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
733404|NCT01679314|O1|Outcome|Active AlphaCore Device|"Active AlphaCore Device~Each study group will go under the same treatment regimen and assessments."
733377|NCT01679613|P1|Participant Flow|Nintedanib (Pilot Part)/ Nintedanib+Ketoconazole (Pilot Part)|Nintedanib 50mg was given as a single dose (Treatment A). Following a wash out period of at least 14 days, ketoconazole 400mg was given once daily for three days and nintedanib 50 mg was given as a single dose 1 hour (h) after the ketoconazole administration with ketoconazole under steady-state conditions (Treatment B)
733378|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733379|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733380|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733381|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733382|NCT01679613|O2|Outcome|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733383|NCT01679613|O1|Outcome|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733384|NCT01679613|E3|Reported Event|Nintedanib + Ketoconazole|"In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2 and 50 mg nintedanib were given as a single dose 1 h after the ketoconazole administration on Day 1, with ketoconazole under steady-state conditions.~In the Main part, alternatively, a single dose of 100mg could have been given 1 h after the ketoconazole administration or 4 h before the ketoconazole administration on Day 1. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733385|NCT01679613|E2|Reported Event|Nintedanib|"In both parts (Pilot and Main) 50 mg of nintedanib were given as a single dose on Day 1.~In the Main part, alternatively, a single dose of 100mg could have been given. The chosen dosing scheme depended on the increase in nintedanib exposure due to ketoconazole co-administration observed in the Pilot part."
733386|NCT01679613|E1|Reported Event|Ketoconazole|In both parts (Pilot and Main) of the study 400 mg ketoconazole were given once daily for 3 days starting on Day -2
733387|NCT01679600|B3|Baseline|Total|Total of all reporting groups
733388|NCT01679600|B2|Baseline|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
733747|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733389|NCT01679600|B1|Baseline|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
733390|NCT01679600|P2|Participant Flow|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
733391|NCT01679600|P1|Participant Flow|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
733392|NCT01679600|O2|Outcome|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
733393|NCT01679600|O1|Outcome|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
733394|NCT01679600|E2|Reported Event|RATE|"Robotics-assisted treadmill exercise~Robotics-assisted treadmill exercise: Conventional robotics-assisted treadmill exercise"
733395|NCT01679600|E1|Reported Event|FC-RATE|"Feedback-controlled robotics-assisted treadmill exercise~Feedback-controlled robotics-assisted treadmill exercise: Human-in-the-loop feedback system to control individual's active work rate"
733396|NCT01679314|B3|Baseline|Total|Total of all reporting groups
733397|NCT01679314|B2|Baseline|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733398|NCT01679314|B1|Baseline|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733399|NCT01679314|P2|Participant Flow|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733400|NCT01679314|P1|Participant Flow|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733401|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733402|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733405|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733406|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733407|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733408|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733409|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733410|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733411|NCT01679314|O2|Outcome|Sham AlphaCore Device|Sham AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733412|NCT01679314|O1|Outcome|Active AlphaCore Device|Active AlphaCore Device Each study group will go under the same treatment regimen and assessments.
733413|NCT01679314|O2|Outcome|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733414|NCT01679314|O1|Outcome|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733415|NCT01679314|E2|Reported Event|Sham AlphaCore Device|"AlphaCore sham device~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733416|NCT01679314|E1|Reported Event|Active AlphaCore Device|"AlphaCore active stimulation treatment~AlphaCore device: Each study group will go under the same treatment regimen and assessments."
733417|NCT01679236|B3|Baseline|Total|Total of all reporting groups
733418|NCT01679236|B2|Baseline|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
733419|NCT01679236|B1|Baseline|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
733420|NCT01679236|P2|Participant Flow|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
733466|NCT01679002|B2|Baseline|Group B|BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period BIA 2-093 450 mg bid - OXC 450 mg bid - BIA 2-093 450 mg od
733421|NCT01679236|P1|Participant Flow|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
733422|NCT01679236|O2|Outcome|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
733423|NCT01679236|O1|Outcome|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
733424|NCT01679236|E2|Reported Event|Interactive Learning for Smokers|"Interactive Learning for Smokers (ILS) is a 7-week intervention that provides a closely matched active control group for MTS, but with substantive education and skills training for smoking cessation. To this end, ILS combines elements of two smoking cessation programs, the American Lung Association, Freedom from Smoking program and The Mayo Clinic Nicotine Dependence Center program. ILS participants were asked to practice 30 minutes of silent non-directed walking per day throughout the intervention and were instructed to use non-directed walking for relaxation, stress reduction and as a strategy for managing urges and withdrawal symptoms.~Interactive Learning for Smokers: This provides the Interactive Learning for Smokers intervention (7 weeks long)."
733425|NCT01679236|E1|Reported Event|Mindfulness Training for Smokers|"Mindfulness Training for Smokers (MTS) is a 7-week intervention that provides instruction in mindfulness very similar to the way it is taught in Mindfulnes-Based Stress Reduction. In addition MTS provides mindfulness training targeted to specific smoking relapse challenges. The MTS intervention was designed around a weekly curriculum that provides instruction to help participants learn practices including mindfulness meditation, mindful walking and mindful eating. MTS participants are instructed to practice meditation 30 minutes per day with a guided meditation CD.~Mindfulness Training for Smokers: The provides the Mindfulness Training for Smokers intervention (7 weeks long)."
733426|NCT01679197|B1|Baseline|Treatment|"Metreleptin~Metreleptin"
733427|NCT01679197|P1|Participant Flow|Treatment|"Metreleptin~Metreleptin"
733428|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
733429|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
733430|NCT01679197|O4|Outcome|LDL mg/dL|Lipid measurement
733431|NCT01679197|O3|Outcome|HDL Cholesterol mg/dL|Lipid measurement
733432|NCT01679197|O2|Outcome|Triglycerides mg/dL|Lipid measurement
733433|NCT01679197|O1|Outcome|Cholesterol, Total mg/dL|Lipid measurement
733434|NCT01679197|O2|Outcome|Liver Function ALT|
733435|NCT01679197|O1|Outcome|Liver Function AST|
733436|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
733437|NCT01679197|O1|Outcome|Treatment|"Metreleptin~Metreleptin"
733438|NCT01679197|E1|Reported Event|Treatment|"Metreleptin~Metreleptin"
733439|NCT01679028|B7|Baseline|Total|Total of all reporting groups
733440|NCT01679028|B6|Baseline|T89 Group C|T89 225mg bid for 14 days
733441|NCT01679028|B5|Baseline|Placebo Group C|Placebo 225mg bid for 14 days
733442|NCT01679028|B4|Baseline|T89 Group B|T89 300mg single dose
733443|NCT01679028|B3|Baseline|Placebo Group B|Placebo 300mg single dose
733444|NCT01679028|B2|Baseline|T89 Group A|T89 150mg single dose
733445|NCT01679028|B1|Baseline|Placebo Group A|Placebo 150mg single dose
733446|NCT01679028|P6|Participant Flow|T89 Group C|T89 225mg bid for 14 days
733447|NCT01679028|P5|Participant Flow|Placebo Group C|Placebo 225mg bid for 14 days
733448|NCT01679028|P4|Participant Flow|T89 Group B|T89 300mg single dose
733449|NCT01679028|P3|Participant Flow|Placebo Group B|Placebo 300mg single dose
733450|NCT01679028|P2|Participant Flow|T89 Group A|T89 150mg single dose
733451|NCT01679028|P1|Participant Flow|Placebo Group A|Placebo 150mg single dose
733452|NCT01679028|O6|Outcome|T89 Group C|T89 225mg bid for 10 days
733453|NCT01679028|O5|Outcome|Placebo Group C|225mg bid for 10 days
733454|NCT01679028|O4|Outcome|T89 Group B|300mg T89; single dose
733455|NCT01679028|O3|Outcome|Placebo Group B|300mg Placebo; single dose
733456|NCT01679028|O2|Outcome|T89 Group A|150mg T89; Single dose
733457|NCT01679028|O1|Outcome|Placebo Group A|150 mg placebo; single dose
733458|NCT01679028|E6|Reported Event|T89 Group C|T89 225mf bid for 14 days
733459|NCT01679028|E5|Reported Event|Placebo Group C|Placebo 225mg bid for 14 days
733460|NCT01679028|E4|Reported Event|T89 Group B|300mg T89 single dose
733461|NCT01679028|E3|Reported Event|Placebo Group B|300mg Placebo single dose
733462|NCT01679028|E2|Reported Event|T89 Group A|150mg T89 single dose
733463|NCT01679028|E1|Reported Event|Placebo Group A|150 mg Placebo Single dose
733464|NCT01679002|B4|Baseline|Total|Total of all reporting groups
733465|NCT01679002|B3|Baseline|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 450 mg od - BIA 2-093 450 mg bid
733467|NCT01679002|B1|Baseline|Group A|BIA 2-093 450 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period BIA 2-093 450 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid
733468|NCT01679002|P3|Participant Flow|Group C|oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period OXC 450 mg bid - BIA 2-093 900 mg od - BIA 2-093 450 mg bid
733469|NCT01679002|P2|Participant Flow|Group B|"BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period followed by BIA 2-093 900 mg once-daily period~BIA 2-093 450 mg bid OXC 450 mg bid BIA 2-093 900 mg od"
733470|NCT01679002|P1|Participant Flow|Group A|"BIA 2-093 900 mg once-daily period followed by BIA 2-093 450 mg twice-daily period followed by oxcarbazepine 450 mg twice-daily period.~BIA 2-093 900 mg od - BIA 2-093 450 mg bid - OXC 450 mg bid"
733471|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
733472|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
733473|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
733474|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
733475|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
733476|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
733477|NCT01679002|O3|Outcome|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
733478|NCT01679002|O2|Outcome|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
733479|NCT01679002|O1|Outcome|BIA 2-093 900 mg od|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
733480|NCT01679002|E3|Reported Event|Oxcarbazepine 450 mg Bid|OXC, Oxcarbazepine 450 mg bid
733481|NCT01679002|E2|Reported Event|BIA 2-093 450 mg Bid|ESL, Eslicarbazepine acetate BIA 2-093 450 mg bid
733482|NCT01679002|E1|Reported Event|BIA 2-093 900 mg|ESL, Eslicarbazepine acetate BIA 2-093 900 mg od
733483|NCT01678976|B3|Baseline|Total|Total of all reporting groups
733484|NCT01678976|B2|Baseline|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
733485|NCT01678976|B1|Baseline|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
733486|NCT01678976|P2|Participant Flow|Period 1 - Oxcarbazepine; Period 2 - BIA 2-093|Period 1 - Subjects recieved 900 mg of oxcarbazepine Period 2 - Subjects recieved 900 mg of BIA 2-093
733487|NCT01678976|P1|Participant Flow|Period 1 - BIA 2-093; Period 2 - Oxcarbazepine|Period 1 - Subjects recieved 900 mg of BIA 2-093 Period 2 - Subjects recieved 900 mg of oxcarbazepine
733488|NCT01678976|O2|Outcome|Oxcarbazepine|Oxcarbazepine, Trileptal
733489|NCT01678976|O1|Outcome|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
733490|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
733491|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL, Eslicarbazepine acetate
733492|NCT01678976|O2|Outcome|Oxcarbazepine 900 mg od|Oxcarbazepine, Trileptal®
733493|NCT01678976|O1|Outcome|BIA 2-093 900 mg od|BIA 2-093, ESL Eslicarbazepine acetate
733494|NCT01678976|E2|Reported Event|Oxcarbazepine|Oxcarbazepine, Trileptal
733495|NCT01678976|E1|Reported Event|BIA 2-093|BIA 2-093, ESL, Eslicarbazepine
733496|NCT01678911|B1|Baseline|All Subjects|All randomized subjects
733497|NCT01678911|P2|Participant Flow|Gralise Then Placebo|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
733498|NCT01678911|P1|Participant Flow|Placebo, Then Gralise|Subjects may receive a pill with no medicine.
733499|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
733500|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
733501|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
733502|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
733503|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
733504|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
733505|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
733506|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
733507|NCT01678911|O2|Outcome|Gralise Then Placebo|Subjects recieve Gralise (a long acting gabapentinoid) for phase 1.Subject washout, then cross over to placebo in Phase 2.
733508|NCT01678911|O1|Outcome|Placebo Then Gralise|Subjects may receive a pill with no medicine (placebo) for phase 1. Subject washout, then cross over to Gralise in Phase 2.
733509|NCT01678911|E2|Reported Event|Gralise|"Gralise (a long acting gabapentinoid)~Gralise: Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of “wash-out” before repeating the above procedure for the other arm of the study (placebo or medication)."
733510|NCT01678911|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
733511|NCT01678885|B3|Baseline|Total|Total of all reporting groups
733512|NCT01678885|B2|Baseline|Sub-study 2|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
733513|NCT01678885|B1|Baseline|Sub-study 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
733514|NCT01678885|P5|Participant Flow|Phase 2- Low-Calorie Diet|"Participants from sub-study 1 and 2 had the chance to receive the low-calorie diet based on their eligibility; i.e., BMI level.~Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected."
733515|NCT01678885|P4|Participant Flow|Phase I Sub Study 2 - Sensewear First, Then Digital Photo|Phase 1- sensewear First, Then Digital Photography
733516|NCT01678885|P3|Participant Flow|Phase 1 Sub Study 2 - Dig Photo First, Then Sensewear|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
733517|NCT01678885|P2|Participant Flow|Phase 1 Sub-study 1 - IDEEA & Actical First, Then Dig Photo|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
733518|NCT01678885|P1|Participant Flow|Phase I Sub-study 1 - Dig Photo First, Then IDEEA & Actical|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
733519|NCT01678885|O1|Outcome|All Participants|All study participants were included in these analyses
733520|NCT01678885|O1|Outcome|All Participants|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods. During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer.During the first week of the doubly labeled water period (day 0 to 7),participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.Participants who complete Phase I of the study will receive a partial supplement low-calorie diet (LCD) for 8 weeks. Participants will return to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data will be collected.
733521|NCT01678885|O1|Outcome|Phase II|Participants who complete Phase I of the study received a partial supplement low-calorie diet (LCD) for 8 weeks. This diet plan was a 1000-1150 kcal/day diet composed of Health One shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data was collected.
733522|NCT01678885|O1|Outcome|Phase 1|During the first week of the doubly labeled water period (day 0 to 7), participants in group 1 will use digital photography of foods (RFPM). During the second week of the doubly labeled water phase, participants in this group will wear the Intelligent Device for Energy Expenditure and Activity (IDEEA) monitor and an accelerometer. Participants in group 2 will wear the IDEEA monitor and accelerometer in the first week of the doubly labeled water period and digital photography of foods during the second week.
733523|NCT01678885|E2|Reported Event|Sub-study 2|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
733524|NCT01678885|E1|Reported Event|Sub-study 1|Participants completed 2 phases of the study. Phase I included a 2-week doubly labeled water period where they also wore activity trackers for one week, and used a food photography method for the other week. Phase II was an 8-week partial supplement low-calorie diet (LCD). This diet plan was a 1000-1150 kcal/day diet composed of HealthOne shakes and prepackaged portion controlled foods or home-cooked meals that participants completed in a free-living environment. Participants returned to follow-up at six and twelve months after they completed the LCD. During these assessments, anthropometric and questionnaire data were collected.
733525|NCT01678846|B3|Baseline|Total|Total of all reporting groups
733526|NCT01678846|B2|Baseline|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
733527|NCT01678846|B1|Baseline|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
733528|NCT01678846|P2|Participant Flow|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
733542|NCT01678820|B2|Baseline|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733767|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733529|NCT01678846|P1|Participant Flow|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
733530|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
733531|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
733532|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
733533|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
733534|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
733535|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
733536|NCT01678846|O2|Outcome|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
733743|NCT01677182|B1|Baseline|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733537|NCT01678846|O1|Outcome|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
733538|NCT01678846|E2|Reported Event|Control|Schools in this arm will receive the Good Schools Toolkit materials and some implementation support after the end of the trial.
733539|NCT01678846|E1|Reported Event|Good School Toolkit|"Schools in the intervention arm will receive the Good Schools Toolkit materials and implementation support.~Good School Toolkit: The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php)."
733540|NCT01678820|B4|Baseline|Total|Total of all reporting groups
733541|NCT01678820|B3|Baseline|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733599|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
733543|NCT01678820|B1|Baseline|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733544|NCT01678820|P3|Participant Flow|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733545|NCT01678820|P2|Participant Flow|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733546|NCT01678820|P1|Participant Flow|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733547|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733548|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733549|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733550|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733551|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733552|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733553|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733554|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733555|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733556|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733557|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733558|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733600|NCT01678807|E3|Reported Event|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
733559|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733560|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733561|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733562|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733563|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733564|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733565|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733566|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733567|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733568|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733569|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733570|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733571|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733572|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733573|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733574|NCT01678820|O2|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733601|NCT01678807|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
733575|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733576|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733577|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733578|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733579|NCT01678820|O3|Outcome|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733580|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733581|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733582|NCT01678820|O2|Outcome|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733583|NCT01678820|O1|Outcome|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733584|NCT01678820|E3|Reported Event|Simvastatin|Simvastatin 40 mg plus placebo to sitagliptin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733585|NCT01678820|E2|Reported Event|Sitagliptin|Sitagliptin 100 mg plus placebo to simvastatin plus placebo to sitagliptin/simvastatin FDC administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733586|NCT01678820|E1|Reported Event|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC plus placebo to sitagliptin plus placebo to simvastatin administered orally once daily in the evening. Participants will continue on their stable pre-screening metformin dose and dosing regimen of >=1500 mg daily for the duration of the study. Participants may receive glimepiride 1 mg once daily or 2 mg once daily (may be up-titrated to 6 mg once daily) as rescue therapy.
733587|NCT01678807|B4|Baseline|Total|Total of all reporting groups
733588|NCT01678807|B3|Baseline|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
733589|NCT01678807|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
733590|NCT01678807|B1|Baseline|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
733591|NCT01678807|P3|Participant Flow|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
733592|NCT01678807|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
733593|NCT01678807|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
733594|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
733595|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
733596|NCT01678807|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
733597|NCT01678807|O3|Outcome|Placebo|Participants received a rapidly dissolving placebo tablet administered sublingually q.d. for 28 days
733598|NCT01678807|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d. for 28 days
733602|NCT01678807|E1|Reported Event|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.) for 28 days
733603|NCT01678313|B3|Baseline|Total|Total of all reporting groups
733604|NCT01678313|B2|Baseline|Control Group|Doxazosin 4 mg alone everyday, complete 3 month therapy N=58(82.9%)
733605|NCT01678313|B1|Baseline|Study Group|Doxazosin 4 mg daily plus celecoxib 200 mg daily, complete 3 month therapy N=64(91.4%)
733606|NCT01678313|P2|Participant Flow|Control Group|Doxazosin 4 mg every day (QD)
733607|NCT01678313|P1|Participant Flow|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733608|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
733609|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733610|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
733611|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733612|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
733613|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733614|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
733615|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733616|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
733617|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733618|NCT01678313|O2|Outcome|Control Group|Doxazosin 4 mg every day (QD)
733619|NCT01678313|O1|Outcome|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733620|NCT01678313|E2|Reported Event|Control Group|Doxazosin 4 mg every day (QD)
733621|NCT01678313|E1|Reported Event|Study Group|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)
733622|NCT01678196|B3|Baseline|Total|Total of all reporting groups
733623|NCT01678196|B2|Baseline|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
733624|NCT01678196|B1|Baseline|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
733625|NCT01678196|P2|Participant Flow|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
733626|NCT01678196|P1|Participant Flow|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
733627|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
733628|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
733629|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
733630|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
733631|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
733632|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
733633|NCT01678196|O2|Outcome|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
733634|NCT01678196|O1|Outcome|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
733635|NCT01678196|E2|Reported Event|Control|"Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention~Control: Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention"
733636|NCT01678196|E1|Reported Event|VA-CRAFT|"Family participants complete an on-line training course (VA-CRAFT) over a 3 month period~VA-CRAFT: VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions."
733637|NCT01678131|B4|Baseline|Total|Total of all reporting groups
733638|NCT01678131|B3|Baseline|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733639|NCT01678131|B2|Baseline|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733640|NCT01678131|B1|Baseline|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
733641|NCT01678131|P3|Participant Flow|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733642|NCT01678131|P2|Participant Flow|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733643|NCT01678131|P1|Participant Flow|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
733644|NCT01678131|O3|Outcome|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733645|NCT01678131|O2|Outcome|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733646|NCT01678131|O1|Outcome|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733647|NCT01678131|E3|Reported Event|600 mg Vaniprevir + PegIFN/RBV|Participants received 600 mg vaniprevir from Days 1-7; Peg-IFN once weekly, RBV twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733648|NCT01678131|E2|Reported Event|300 mg Vaniprevir + PegIFN/RBV|Participants received 300 mg vaniprevir from Days 1-7; Pegylated Interferon (Peg-IFN) alpha-2b once weekly, Ribavirin (RBV) twice daily from Day 1 up to Day 21; and had postdose liver biopsy from Day 7 up to Day 10 done by FNA and CNB.
733649|NCT01678131|E1|Reported Event|600 mg Vaniprevir|Participants received 600 mg vaniprevir only from Days 1-7; and had postdose liver biopsy from Day 7 up to Day 10 done by Fine Needle Aspiration (FNA) and Core Needle Biopsy (CNB).
733650|NCT01677988|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733651|NCT01677988|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733652|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733653|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733654|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733655|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733656|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733657|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733658|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733659|NCT01677988|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for -08 weeks, then surgical resection
733660|NCT01677988|E1|Reported Event|Chemotherapy, Chemoradiation, Surgery|Neoadjuvant chemotherapy - modified FOLFIRINOX chemotherapy Day and and Day 15 of 28 days cycles for 3 cycles with growth factor support followed by chemoradiation for 6-8 weeks, then surgical resection
733661|NCT01677936|B3|Baseline|Total|Total of all reporting groups
733662|NCT01677936|B2|Baseline|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
733663|NCT01677936|B1|Baseline|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
733664|NCT01677936|P2|Participant Flow|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
733763|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733665|NCT01677936|P1|Participant Flow|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
733666|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
733667|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
733668|NCT01677936|O2|Outcome|Snack Group|"Subjects randomized to the snack group will consume 100 calorie snack packs three times a day, before meals, and with water or other non-caloric beverages (i.e. tea). Subjects will consume the snack packs over a 12 week period.~Snacks: 100 calorie snack packs will be administered to the subjects in the snack group"
733669|NCT01677936|O1|Outcome|Raisin|"Subjects randomized to the raisin treatment arm will consume raisins three times a day, prior to meals, and with a glass of water or non-caloric beverages (i.e. tea). Subjects will consume the raisins over a 12 week period.~Raisins: 1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm"
733670|NCT01677936|E2|Reported Event|Snacks|Snack group
733671|NCT01677936|E1|Reported Event|Raisin|Raisin group
733672|NCT01677767|B1|Baseline|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733673|NCT01677767|P1|Participant Flow|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733674|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia who had been on other ESAs and had Hb greater than or equal to (≥)10 g/dL at baseline.
733675|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733676|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733677|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733678|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733679|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733680|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
733681|NCT01677767|O1|Outcome|C.E.R.A.|Participants with Hb less than (<) 10 g/dL at enrollment were evaluated for correction of anemia.
733682|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733683|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733684|NCT01677767|O1|Outcome|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733685|NCT01677767|E1|Reported Event|C.E.R.A.|Participants with chronic renal anemia received C.E.R.A according to routine clinical practice treatment in line with approved prescribing information for a duration of 6 months/24 weeks.
733686|NCT01677624|B1|Baseline|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
733687|NCT01677624|P1|Participant Flow|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
733688|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
733689|NCT01677624|O1|Outcome|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
733690|NCT01677624|E1|Reported Event|Device E7040|An optimal dose and size (100 to 300 μm, 300 to 500 μm, 500 to 700 μm) of microsphere that best matches the pathology (i.e., vascular target, vessel size, and target lesion) and the extent of embolization were carefully selected.
733691|NCT01677299|B5|Baseline|Total|Total of all reporting groups
733692|NCT01677299|B4|Baseline|Sequence DACB|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
733693|NCT01677299|B3|Baseline|Sequence CDBA|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
733694|NCT01677299|B2|Baseline|Sequence ABDC|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
733695|NCT01677299|B1|Baseline|Sequence BCAD|A = 1000 mg EFB0026 BID B = 1000 mg EFB0027 BID C = 500 mg EFB0027 BID D = 500 mg EFB0026 BID plus 1000 mg EFB0027 BID
733764|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733696|NCT01677299|P4|Participant Flow|Sequence 4: DACB|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
733697|NCT01677299|P3|Participant Flow|Sequence 3: CDBA|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
733698|NCT01677299|P2|Participant Flow|Sequence 2: ABDC|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
733699|NCT01677299|P1|Participant Flow|Sequence 1: BCAD|"BID~Treatment A = 1000 mg EFB0026 (Met IR) Treatment B = 1000 mg EFB0027 (Met DR) Treatment C = 500 mg EFB0027 (Met DR) Treatment D = 500 mg EFB0026 (Met IR) plus 1000 mg EFB0027 (Met DR)"
733700|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
733701|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
733702|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
733703|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
733704|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
733705|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
733706|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
733707|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
733708|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK~EFB0026: Active comparator"
733709|NCT01677299|O3|Outcome|500 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
733710|NCT01677299|O2|Outcome|1000 mg EFB0027|"BID~EFB0027: Comparison of enteric-coating to assess effect on PK"
733711|NCT01677299|O1|Outcome|1000 mg EFB0026|"BID~EFB0026: Active comparator"
733712|NCT01677299|O4|Outcome|500 mg EFB0026 + 1000 mg EFB0027|BID
733713|NCT01677299|O3|Outcome|500 mg EFB0027|BID
733714|NCT01677299|O2|Outcome|1000 mg EFB0027|BID
733715|NCT01677299|O1|Outcome|1000 mg EFB0026|BID
733716|NCT01677299|E4|Reported Event|500 mg EFB0026 BID Plus 1000 mg EFB0027 BID|D: Metformin immediate plus Metformin delayed release
733717|NCT01677299|E3|Reported Event|500 mg EFB0027 BID|C: Metformin delayed release BID
733718|NCT01677299|E2|Reported Event|1000 mg EFB0027 BID|B: Metformin delayed release BID
733719|NCT01677299|E1|Reported Event|1000 mg EFB0026 BID|A: Metformin immediate release BID
733720|NCT01677286|B1|Baseline|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
733721|NCT01677286|P1|Participant Flow|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth will be administered to subjects for 12 months.
733722|NCT01677286|O1|Outcome|Amyloid Nephropathy: Proteinuria (g/Day)|Patients with predominant amyloid kidney involvement at enrollment.
733723|NCT01677286|O1|Outcome|Amyloid Nephropathy|Patients with predominant amyloid kidney involvement at enrollment.
733724|NCT01677286|O1|Outcome|Cardiomyopathy|Patients with predominant amyloid involvement of the heart.
733725|NCT01677286|O1|Outcome|Cardiomyopathy|Patients with predominant amyloid involvement of the heart.
733726|NCT01677286|E1|Reported Event|Doxycycline 100 mg po Bid x 12 Months|Open-label doxycycline 100 mg twice daily by mouth was administered to subjects for 12 months, if tolerated.
733727|NCT01677195|B4|Baseline|Total|Total of all reporting groups
733728|NCT01677195|B3|Baseline|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
733729|NCT01677195|B2|Baseline|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733730|NCT01677195|B1|Baseline|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733731|NCT01677195|P3|Participant Flow|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
733732|NCT01677195|P2|Participant Flow|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733765|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733733|NCT01677195|P1|Participant Flow|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733734|NCT01677195|O3|Outcome|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
733735|NCT01677195|O2|Outcome|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733736|NCT01677195|O1|Outcome|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733737|NCT01677195|E3|Reported Event|Placebo|"Participants will receive placebo capsules shown not to absorb mycotoxins three times a day with meals.~Placebo: Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article."
733738|NCT01677195|E2|Reported Event|ACCS100 Low Dose|"Participants will receive a total daily dose of 1.5 grams of ACCS100; 500 mgs three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733739|NCT01677195|E1|Reported Event|ACCS100 High Dose|"Participants will receive a total daily dose of 3 grams of ACCS100; 1 gram three times a day with meals.~ACCS100: ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article."
733740|NCT01677182|B4|Baseline|Total|Total of all reporting groups
733741|NCT01677182|B3|Baseline|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733742|NCT01677182|B2|Baseline|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733748|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733749|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733750|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733751|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733752|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733753|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733754|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733755|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733756|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733757|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733758|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733759|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733760|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733761|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733762|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733768|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733769|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733770|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733771|NCT01677182|O3|Outcome|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733772|NCT01677182|O2|Outcome|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733773|NCT01677182|O1|Outcome|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733774|NCT01677182|E3|Reported Event|TAK-375SL 0.4 mg|TAK-375SL (ramelteon) 0.4 mg, tablet, sublingually, once daily for up to 6 weeks.
733775|NCT01677182|E2|Reported Event|TAK-375SL 0.1 mg|TAK-375SL (ramelteon) 0.1 mg, tablet, sublingually, once daily for up to 6 weeks.
733776|NCT01677182|E1|Reported Event|Placebo|TAK-375SL (ramelteon) placebo-matching tablet, sublingually, once daily for up to 6 weeks.
733777|NCT01676896|B4|Baseline|Total|Total of all reporting groups
733778|NCT01676896|B3|Baseline|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733779|NCT01676896|B2|Baseline|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733780|NCT01676896|B1|Baseline|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733781|NCT01676896|P3|Participant Flow|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733782|NCT01676896|P2|Participant Flow|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733783|NCT01676896|P1|Participant Flow|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733784|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733785|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733786|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733886|NCT01676532|O1|Outcome|Sprucecourt Public School Vs Other Participating Schools|The number of students from the host school of the SBHC and other participating schools
733787|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733788|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733789|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733790|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733791|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733792|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733793|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733794|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733805|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733795|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733796|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733797|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733809|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733798|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733799|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733800|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733801|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733802|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733803|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733804|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733942|NCT01676220|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733806|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733807|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733808|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733832|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733810|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733811|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733812|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733813|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733814|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733815|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733816|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733817|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733818|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733819|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733820|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733844|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733821|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733822|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733823|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733824|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733825|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733826|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733827|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733863|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733828|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733829|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733830|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733831|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733880|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
733833|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733834|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733835|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733836|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733837|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733838|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733839|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733840|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733841|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733842|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733843|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733881|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
733845|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733846|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733847|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733848|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733849|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733850|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733851|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733852|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733853|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733854|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733855|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733882|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days.
733856|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733857|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733858|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733859|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733860|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733861|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733862|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733924|NCT01676298|P1|Participant Flow|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733925|NCT01676298|O8|Outcome|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733926|NCT01676298|O7|Outcome|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733864|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733865|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733866|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733883|NCT01676714|E1|Reported Event|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
733884|NCT01676532|B1|Baseline|Students Attending SBHC|"Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.~Students attending SBHC: School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC"
733867|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733868|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733869|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733870|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733871|NCT01676896|O3|Outcome|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733872|NCT01676896|O2|Outcome|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733873|NCT01676896|O1|Outcome|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733927|NCT01676298|O6|Outcome|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733928|NCT01676298|O5|Outcome|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733929|NCT01676298|O4|Outcome|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733874|NCT01676896|E3|Reported Event|Health Promotion In-school Class|"The mock comparison follows the in-school format of 16 15-minute sessions; scheduled 3 sessions/week. The content is provided by trained health educators and includes skills practice (i.e., handwashing and brushing teeth) and health promotion topics of nutrition, healthy snacks, preventing colds, and safe exercise.~Health Promotion in-school class"
733875|NCT01676896|E2|Reported Event|Asthma Day Camp|"The asthma day camp is provided in a single day session (5.5 hours total) by trained camp staff. The same skills (i.e., placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters) and topics [a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner] are covered as those in the asthma in-school classes.~Asthma Day Camp"
733876|NCT01676896|E1|Reported Event|Asthma In-school Class|"Provided in 16 15-minute sessions (4 hours total didactic time); scheduled 3 sessions/week. The content is provided by trained asthma educators. The Asthma Plan for Kids (AP-K) is a 7-step curriculum for children to use when responding to asthma symptoms. Skills practice with placebo metered dose inhaler (MDI) and peak expiratory flow (PEF) meters with PEF score interpretation. Topics include (a) identifying lung function, asthma warning signs, symptoms, and triggers; (b) learning skills to manage symptoms, including PEF meter score interpretation, communication with adults (e.g. teachers, coaches, family members), medication use and MDI technique; (c) evaluating asthma symptoms and the effectiveness of management; and (d) discussing how to stay active in a safe manner.~Asthma in-school class"
733877|NCT01676714|B1|Baseline|Dovitinib|"500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.~Dovitinib"
733878|NCT01676714|P1|Participant Flow|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
733879|NCT01676714|O1|Outcome|Dovitinib|500 mg of dovitinib (5 capsules) once a day for 5 continuous days and stop for 2 days. Continue to take dovitinib capsules in this manner until until progression or unacceptable toxicity develops.
733885|NCT01676532|P1|Participant Flow|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
733887|NCT01676532|O1|Outcome|Number of Students From Sprucecourt Who Enrolled in SBHC|From the total number of students who enrolled in the SBHC, the number of students from the host school (Sprucecourt) was calculated
733888|NCT01676532|O1|Outcome|Number of Referrals Made for Students Attending SBHC|Types and number of referrals made for students attending SBHC.
733889|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Diagnoses|Porportion of students attending SBHC with new diagnoses
733890|NCT01676532|O1|Outcome|Number of Students Attending SBHC With New Treatment Plans|The total number of students who attended SBHC that had new treatment plans proposed
733891|NCT01676532|O1|Outcome|Students Attending SBHC|Students who were enrolled at the SBHC and then attended the SBHC
733892|NCT01676532|E1|Reported Event|Students Attending SBHC|Students who attend the SBHC from either Sprucecourt Public School or any other participating schools.
733893|NCT01676415|B3|Baseline|Total|Total of all reporting groups
733894|NCT01676415|B2|Baseline|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
733895|NCT01676415|B1|Baseline|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
733896|NCT01676415|P2|Participant Flow|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
733897|NCT01676415|P1|Participant Flow|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
733898|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
733930|NCT01676298|O3|Outcome|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733931|NCT01676298|O2|Outcome|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733932|NCT01676298|O1|Outcome|*1/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733933|NCT01676298|E8|Reported Event|*2/*17 CYP2C19 Genotype|
733899|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
733900|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
733901|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
733902|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
733903|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
733949|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733950|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733904|NCT01676415|O2|Outcome|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
733905|NCT01676415|O1|Outcome|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
733906|NCT01676415|E2|Reported Event|Topical Mometasone|"Topical steroid medication~Topical mometasone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
733907|NCT01676415|E1|Reported Event|Prednisone|"Oral steroid medication~Prednisone: Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead~Antihistamines if an appropriate history of atopy is obtained~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
733908|NCT01676298|B9|Baseline|Total|Total of all reporting groups
733909|NCT01676298|B8|Baseline|*2/*17 CYP2C19 Genotype|
733910|NCT01676298|B7|Baseline|*2/*3 CYP2C19 Genotype|
733911|NCT01676298|B6|Baseline|*17/*17 CYP2C19 Genotype|
733912|NCT01676298|B5|Baseline|*1/*17 CYP2C19 Genotype|
733913|NCT01676298|B4|Baseline|*3/*1 CYP2C19 Genotype|
733914|NCT01676298|B3|Baseline|*2/*2 CYP2C19 Genotype|
733915|NCT01676298|B2|Baseline|*1/*2 CYP2C19 Genotype|
733916|NCT01676298|B1|Baseline|*1/*1 CYP2C19 Genotype|
733917|NCT01676298|P8|Participant Flow|*2/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733918|NCT01676298|P7|Participant Flow|*2/*3 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733919|NCT01676298|P6|Participant Flow|*17/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733920|NCT01676298|P5|Participant Flow|*1/*17 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733921|NCT01676298|P4|Participant Flow|*3/*1 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733922|NCT01676298|P3|Participant Flow|*2/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733923|NCT01676298|P2|Participant Flow|*1/*2 CYP2C19 Genotype|Subject had genotype confirmed via bi-directional sequencing.
733943|NCT01676220|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733944|NCT01676220|P2|Participant Flow|Lantus (Insulin Glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
733945|NCT01676220|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with non-insulin antihyperglycemic drug(s).
733946|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733947|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733948|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733951|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733952|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733953|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733954|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
733955|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of non-insulin antihyperglycemic drug(s).
733956|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733957|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733958|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733959|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733960|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733961|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733962|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733963|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733964|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733965|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733966|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733967|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733968|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733969|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733970|NCT01676220|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733971|NCT01676220|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with non-insulin antihyperglycemic drug(s).
733972|NCT01676220|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
733973|NCT01676220|E1|Reported Event|HOE901-U300|HOE901­U300 SC injection once daily for 12 months in combination with non­insulin antihyperglycemic drug(s).
733974|NCT01676012|B1|Baseline|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
733975|NCT01676012|P1|Participant Flow|Five Types of Bronchoscopy|"Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
733976|NCT01676012|O1|Outcome|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
733977|NCT01676012|E1|Reported Event|Five Types of Bronchoscopy|"Bronchoscopy will be performed in a standardized order using five different imaging modes.~Standard white light videobronchoscopy (WLB)~High Definition -Bronchoscopy~HD-bronchoscopy + surface enhancement (iScan-surface)~HD-bronchoscopy + tone enhancement (iScan-tone)~Auto Fluorescence Bronchoscopy (AFB - SAFE3000) in dual video mode"
733978|NCT01675830|B1|Baseline|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
733979|NCT01675830|P1|Participant Flow|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
733980|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
733981|NCT01675830|O1|Outcome|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
733982|NCT01675830|E1|Reported Event|Head Wrap Device|Heat Retention Head Wrap: Applied to infant's heads during the rewarming process of CPB
733983|NCT01675661|B3|Baseline|Total|Total of all reporting groups
734010|NCT01675492|B1|Baseline|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
733984|NCT01675661|B2|Baseline|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733985|NCT01675661|B1|Baseline|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733986|NCT01675661|P2|Participant Flow|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
734017|NCT01675453|B1|Baseline|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
733987|NCT01675661|P1|Participant Flow|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733988|NCT01675661|O4|Outcome|Baseline Non-Smokder Placebo Plus CM|This analysis divided folks by baseline smoking status. This is the group of non-smokers randomized to the matched placebo arm and received placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
733989|NCT01675661|O3|Outcome|Baseline Non-Smoker NAC Plus CM|This analysis divided participants by baseline smoking status. This is the group of non-smokers randomized to the N-Acetylcysteine 1200mg twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
733990|NCT01675661|O2|Outcome|Baseline Smoker Placebo Plus CM|"Placebo plus Contingency Management (CM)~This analysis divided folks by baseline smoking status. Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733991|NCT01675661|O1|Outcome|Baseline Smoker NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~This analysis divided those by baseline smoking status. N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733992|NCT01675661|O2|Outcome|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733993|NCT01675661|O1|Outcome|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733994|NCT01675661|O2|Outcome|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733995|NCT01675661|O1|Outcome|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733996|NCT01675661|E2|Reported Event|Placebo Plus CM|"Placebo plus Contingency Management (CM)~Placebo: Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733997|NCT01675661|E1|Reported Event|NAC Plus CM|"N-acetylcysteine (NAC) plus Contingency Management (CM)~N-Acetylcysteine: Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions."
733998|NCT01675544|B1|Baseline|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
733999|NCT01675544|P1|Participant Flow|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
734000|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
734001|NCT01675544|O1|Outcome|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
734002|NCT01675544|E1|Reported Event|Heart Failure Admission|"Patients admitted for acute decompensated heart failure~Electrocardiogram: EKG voltage changes between admission and discharge~Six minute walk test"
734003|NCT01675531|B1|Baseline|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
734004|NCT01675531|P1|Participant Flow|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
734005|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
734006|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
734007|NCT01675531|O1|Outcome|Oxycontin/Naloxone|"Targin(Oxycontin/Naloxone)~Targin: Single arm for Targin"
734008|NCT01675531|O1|Outcome|Oxycodone/Naloxone|"Targin~Targin: Single arm for Targin"
734009|NCT01675531|E1|Reported Event|Oxycodone/Naloxone|"Targin(Oxycodone/Naloxone)~Targin: Single arm for Targin"
734011|NCT01675492|P1|Participant Flow|Wave-front Guided LASIK|Vision correction for a mixed astigmatism refraction
734012|NCT01675492|O1|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
734013|NCT01675492|O1|Outcome|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for a mixed astigmatism refraction
734014|NCT01675492|E1|Reported Event|Wave-front Guided LASIK|LASIK: Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System for mixed astigmatism refraction
734015|NCT01675453|B3|Baseline|Total|Total of all reporting groups
734016|NCT01675453|B2|Baseline|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
734018|NCT01675453|P2|Participant Flow|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
734019|NCT01675453|P1|Participant Flow|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
734020|NCT01675453|O2|Outcome|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
734021|NCT01675453|O1|Outcome|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
734022|NCT01675453|E2|Reported Event|0.9% NaCl (Control Group)|"On-pump CABG. 0.9% NaCl (isotonic saline) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~0.9% NaCl"
734023|NCT01675453|E1|Reported Event|7.2% NaCl /Hydroxyethyl Starch 200/0.5 (Study Group)|"On-pump CABG. 7.2% NaCl plus 6% hydroxyethyl starch 200/0.5 solution (HyperHAES) 4 mL/kg for 30 min, IV (in the vein), once, starting after the first hemodynamic measurement is obtained (before the beginning of CPB)~7.2% NaCl plus 6% hydroxyethyl starch 200/0.5"
734024|NCT01675427|B1|Baseline|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
734025|NCT01675427|P1|Participant Flow|Participants With Chronic Hepatitis C (CHC)|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
734026|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734027|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734028|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734029|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734030|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734031|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734032|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734033|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734034|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734035|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734036|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734037|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734038|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734039|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734040|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734041|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734042|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734043|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734044|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734045|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734046|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734047|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734048|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734049|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734050|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734051|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734052|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734053|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734054|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734055|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734056|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734057|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734058|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734059|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734060|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734061|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734062|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734063|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734064|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734065|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734066|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734067|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734068|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734069|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734070|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734071|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734072|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734073|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734074|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734075|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734076|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734077|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734078|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734079|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734080|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734081|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734082|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734083|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 AA|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734084|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 AC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734085|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734086|NCT01675427|O3|Outcome|Experienced: ITPA rs1127354 CC|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734087|NCT01675427|O2|Outcome|Experienced: ITPA rs1127354 CA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734088|NCT01675427|O1|Outcome|Experienced: ITPA rs1127354 AA|Treatment-experienced participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734089|NCT01675427|O3|Outcome|Naive: ITPA rs1127354 CC|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CC' confirmed by blood sampling.
734090|NCT01675427|O2|Outcome|Naive: ITPA rs1127354 CA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'CA' confirmed by blood sampling.
734091|NCT01675427|O1|Outcome|Naive: ITPA rs1127354 AA|Treatment-naive participants with CHC with ITPA rs1127354 polymorphism 'AA' confirmed by blood sampling.
734092|NCT01675427|O3|Outcome|Experienced: ITPA rs7270101 AA|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734093|NCT01675427|O2|Outcome|Experienced: ITPA rs7270101 AC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734094|NCT01675427|O1|Outcome|Experienced: ITPA rs7270101 CC|Treatment-experienced participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734095|NCT01675427|O3|Outcome|Naive: ITPA rs7270101 Alanine-Alanine (AA)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AA' confirmed by blood sampling.
734096|NCT01675427|O2|Outcome|Naive: ITPA rs7270101 Alanine-Cysteine (AC)|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'AC' confirmed by blood sampling.
734097|NCT01675427|O1|Outcome|Naive: ITPA rs7270101 CC|Treatment-naive participants with CHC with ITPA rs7270101 polymorphism 'CC' confirmed by blood sampling.
734098|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734099|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734100|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734101|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734102|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734103|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734104|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734105|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734106|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734107|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734108|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734109|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734110|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734111|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734112|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734113|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734114|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734115|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734116|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734117|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734118|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734119|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734120|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734121|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734122|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734123|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734124|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734125|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734126|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734127|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734128|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734129|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734130|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734131|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734132|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734133|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734134|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734135|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734136|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734137|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734138|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734139|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734140|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734141|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734142|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734143|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734144|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734145|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734146|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734147|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734148|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734149|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734150|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734151|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734152|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734153|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734154|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734155|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734156|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734157|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734158|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734159|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734160|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734161|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734162|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734163|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734164|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734165|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734166|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734167|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734168|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734169|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734170|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734171|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734172|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734173|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734174|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734175|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734176|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734177|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734178|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734179|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734180|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734181|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734182|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734183|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734184|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734185|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734186|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734187|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734188|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734189|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734190|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734191|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734192|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734193|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734194|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734195|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734196|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734197|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734198|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734199|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734200|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734201|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734202|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734203|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734204|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734205|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734206|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734207|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734208|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734209|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734210|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734211|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734212|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734213|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734214|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734215|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734216|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734217|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734218|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734219|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734220|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734221|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734222|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734223|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734224|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734225|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734226|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734227|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734228|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734229|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734230|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734231|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734232|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734233|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734234|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734235|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734236|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734237|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734238|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734239|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734240|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734241|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734242|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734243|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734244|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734245|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734246|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734247|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734248|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734249|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734250|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734251|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734252|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734253|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734254|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734255|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734256|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734257|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734258|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734259|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734260|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734261|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734262|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734263|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734264|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734265|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734266|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734267|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734268|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734269|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734270|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734271|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734272|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734273|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734274|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734275|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734276|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734277|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734278|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734279|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734280|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734281|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734282|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734283|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734284|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734285|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734286|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734287|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 GG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734288|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 TG|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734289|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734290|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734291|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734292|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734293|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 TT|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734294|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 TC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734295|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 CC|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734296|NCT01675427|O3|Outcome|Experienced: IL28B rs8099917 GG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734297|NCT01675427|O2|Outcome|Experienced: IL28B rs8099917 TG|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734298|NCT01675427|O1|Outcome|Experienced: IL28B rs8099917 TT|Treatment-experienced participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734299|NCT01675427|O3|Outcome|Naive: IL28B rs8099917 Glycine-Glycine (GG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'GG' confirmed by blood sampling.
734300|NCT01675427|O2|Outcome|Naive: IL28B rs8099917 Threonine-Glycine (TG)|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TG' confirmed by blood sampling.
734301|NCT01675427|O1|Outcome|Naive: IL28B rs8099917 TT|Treatment-naive participants with CHC with IL28B rs8099917 polymorphism 'TT' confirmed by blood sampling.
734302|NCT01675427|O3|Outcome|Experienced: IL28B rs12979860 TT|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734303|NCT01675427|O2|Outcome|Experienced: IL28B rs12979860 TC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734304|NCT01675427|O1|Outcome|Experienced: IL28B rs12979860 CC|Treatment-experienced participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734305|NCT01675427|O3|Outcome|Naive: IL28B rs12979860 Threonine-Threonine (TT)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TT' confirmed by blood sampling.
734306|NCT01675427|O2|Outcome|Naive: IL28B rs12979860 Threonine-Cysteine (TC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'TC' confirmed by blood sampling.
734307|NCT01675427|O1|Outcome|Naive: IL28B rs12979860 Cysteine-Cysteine (CC)|Treatment-naive participants with CHC with IL28B polymorphism rs12979860 'CC' confirmed by blood sampling.
734308|NCT01675427|E1|Reported Event|Participants With CHC|Both treatment-naive and treatment-experienced participants with CHC were enrolled in this prospective, interventional Phase 4 study.
734309|NCT01675167|B3|Baseline|Total|Total of all reporting groups
734310|NCT01675167|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734311|NCT01675167|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734312|NCT01675167|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734313|NCT01675167|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734314|NCT01675167|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
734315|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734316|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734317|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734318|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734319|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734320|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734321|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734322|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734323|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734324|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734325|NCT01675167|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
734326|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734327|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734328|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734329|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734330|NCT01675167|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734421|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
734331|NCT01675167|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
734332|NCT01675167|E3|Reported Event|DB Placebo Film|Placebo buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
734333|NCT01675167|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind titration period
734334|NCT01675167|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, 450, 600, 750, or 900 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration period
734335|NCT01675141|B1|Baseline|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734336|NCT01675141|P1|Participant Flow|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734337|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734338|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734339|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734340|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734341|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734342|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734343|NCT01675141|O1|Outcome|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734344|NCT01675141|E1|Reported Event|Lenalidomide Maintenance Therapy for Multiple Myeloma|"10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.~Lenalidomide: 10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity."
734345|NCT01675128|B4|Baseline|Total|Total of all reporting groups
734346|NCT01675128|B3|Baseline|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734347|NCT01675128|B2|Baseline|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734348|NCT01675128|B1|Baseline|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734349|NCT01675128|P3|Participant Flow|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734350|NCT01675128|P2|Participant Flow|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734351|NCT01675128|P1|Participant Flow|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734352|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734353|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734354|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734355|NCT01675128|O1|Outcome|Phase I Dose Level I & Phase I Dose Level II|"Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.~Phase I Dose Level II Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks."
734356|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734357|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734358|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734359|NCT01675128|O1|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734360|NCT01675128|O2|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734361|NCT01675128|O1|Outcome|Phase I Dose Level 2|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734362|NCT01675128|O3|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734363|NCT01675128|O2|Outcome|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734364|NCT01675128|O1|Outcome|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800 mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734365|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734366|NCT01675128|O1|Outcome|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734367|NCT01675128|O1|Outcome|All Phase I Participants|Irinotecan 160 (and 180) mg/m^2 every other week.
734368|NCT01675128|O1|Outcome|All Phase I Participants|ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734369|NCT01675128|E3|Reported Event|Phase II Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered as an intravenous infusion every week without break, i.e. Days 1, 8, 15 and 22 of a 28-day cycle. Patients will be re-staged every 8 weeks.
734370|NCT01675128|E2|Reported Event|Phase I Dose Level II|Irinotecan 180 mg/m^2 every other week; ISIS 183750 1000mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734371|NCT01675128|E1|Reported Event|Phase I Dose Level I|Irinotecan 160 mg/m^2 every other week; ISIS 183750 started 800mg/every week will be administered intravenously on Cycle 1 Days 1, 3, 5, 8, 15 and 22 of a 28 day cycle, restaged every 8 weeks.
734372|NCT01675063|B1|Baseline|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
734373|NCT01675063|P1|Participant Flow|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
734374|NCT01675063|O1|Outcome|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
734375|NCT01675063|E1|Reported Event|Retia Non-Invasive Sensors|"Sensors will be placed on the patient and connected to an amplifier that produces a waveform for 8 hours post cardiac surgery.~Retia Non-Invasive Sensors: Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform."
734376|NCT01675011|B3|Baseline|Total|Total of all reporting groups
734377|NCT01675011|B2|Baseline|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
734378|NCT01675011|B1|Baseline|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
734379|NCT01675011|P2|Participant Flow|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
734380|NCT01675011|P1|Participant Flow|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
734381|NCT01675011|O2|Outcome|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
734382|NCT01675011|O1|Outcome|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
734383|NCT01675011|E2|Reported Event|Embosphere®|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embosphere®"
734384|NCT01675011|E1|Reported Event|Embozene® Microspheres|"Uterine Fibroid Embolization (UFE)will be used to treat the fibroids. The procedure involves injecting embolizing particles into the uterine artery which causes the fibroid to shrink.~Embozene® Microspheres"
734385|NCT01674725|B3|Baseline|Total|Total of all reporting groups
734386|NCT01674725|B2|Baseline|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734387|NCT01674725|B1|Baseline|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734388|NCT01674725|P2|Participant Flow|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734389|NCT01674725|P1|Participant Flow|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734390|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734391|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734392|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734393|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734394|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734395|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734396|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734397|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734398|NCT01674725|O2|Outcome|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734399|NCT01674725|O1|Outcome|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734400|NCT01674725|E2|Reported Event|ABT-450/r/ABT-267 and ABT-333|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks
734401|NCT01674725|E1|Reported Event|ABT-450/r/ABT-267 and ABT-333, Plus RBV|ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks
734402|NCT01674712|B6|Baseline|Total|Total of all reporting groups
734403|NCT01674712|B5|Baseline|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
734404|NCT01674712|B4|Baseline|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
734405|NCT01674712|B3|Baseline|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
734406|NCT01674712|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
734407|NCT01674712|B1|Baseline|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
734408|NCT01674712|P5|Participant Flow|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
734409|NCT01674712|P4|Participant Flow|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
734410|NCT01674712|P3|Participant Flow|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
734411|NCT01674712|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
734412|NCT01674712|P1|Participant Flow|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
734413|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
734414|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
734415|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
734416|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
734417|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
734418|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
734419|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
734420|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
734422|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
734423|NCT01674712|O5|Outcome|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
734424|NCT01674712|O4|Outcome|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
734425|NCT01674712|O3|Outcome|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
734426|NCT01674712|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
734427|NCT01674712|O1|Outcome|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
734428|NCT01674712|E5|Reported Event|Fenofibrate 145 mg|Fenofibrate 145 mg: Fenofibrate, tablet, 145 mg, once daily, 12 weeks
734429|NCT01674712|E4|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg: simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
734430|NCT01674712|E3|Reported Event|Fenofibrate/Simvastatin 145/40 mg|Fenofibrate/simvastatin 145/40 mg: Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
734431|NCT01674712|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg: Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
734432|NCT01674712|E1|Reported Event|Fenofibrate/Simvastatin 145/20 mg|Fenofibrate/simvastatin 145/20 mg: Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
734433|NCT01674647|B3|Baseline|Total|Total of all reporting groups
734434|NCT01674647|B2|Baseline|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734435|NCT01674647|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734436|NCT01674647|P2|Participant Flow|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734437|NCT01674647|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734438|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734486|NCT01674621|P2|Participant Flow|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
734488|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
734439|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734498|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
734440|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734441|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734442|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734443|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734444|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734445|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734487|NCT01674621|P1|Participant Flow|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
734446|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734492|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
734493|NCT01674621|O5|Outcome|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
734447|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734448|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734449|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734450|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734451|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734452|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734453|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734494|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
734495|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
734454|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734455|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734456|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734457|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734458|NCT01674647|O2|Outcome|Vitamin K Antagonist (VKA)|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734459|NCT01674647|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734460|NCT01674647|E2|Reported Event|Vitamin K Antagonist|Subjects assigned to treatment with VKA received VKA orally once daily titrated to a target INR of 2.5 (range 2.0-3.0, inclusive). The specific VKA was given by the investigator based on local standard of practice. For all subjects randomized to receive VKA, the investigator assessed if a parenteral anticoagulant drug, particularly before cardioversion, was needed as bridging therapy with VKA as standard of care (until target INR was achieved). The duration depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, cardioversion was performed within 1-5 days after randomization. VKA was given for 1-5 days before it and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received VKA for 21 (+4) to 56 (+4) days before cardioversion and for 42 days thereafter. The investigator assessed if long-term anticoagulation was warranted and treated the subject according to standard of care or not. Then subjects entered 30-day follow-up period.
734496|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
734497|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
734461|NCT01674647|E1|Reported Event|Rivaroxaban (Xarelto; BAY59-7939)|Subjects randomized to treatment with rivaroxaban received rivaroxaban 20 milligram (mg) orally once daily. Subjects with moderate renal impairment [i.e., Creatinine clearance (CrCl) of 30 to 49 milliliter per minute (mL/min), inclusive] at screening received the adjusted dose of 15 mg once daily. The duration of the treatment period for a given subject depended on the cardioversion strategy. For subjects in the Direct Cardioversion Strategy, the cardioversion procedure was performed within 1-5 days after randomization. Rivaroxaban was given for 1-5 days before planned direct cardioversion and for 42 days thereafter. Subjects in the Delayed Cardioversion Strategy received rivaroxaban for 21 (+4) to 56 (+4) days prior to cardioversion and for 42 days thereafter. The investigator assessed whether or not long-term anticoagulation was warranted and treated the subject according to standard of care. Then subjects entered 30-day follow-up period.
734462|NCT01674634|B1|Baseline|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734463|NCT01674634|P1|Participant Flow|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734464|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734465|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734466|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734467|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734468|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734469|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734470|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the PIP joint cord
734471|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the MP joint cord
734472|NCT01674634|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the proximal interphalangeal (PIP) joint cord
734473|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX MP Joint|AA4500 (collagenase clostridium histolyticum); 0.58 mg injection in the metacarpophalangeal (MP) joint cord
734474|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734475|NCT01674634|O1|Outcome|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734476|NCT01674634|E1|Reported Event|XIAFLEX/XIAPEX|AA4500 (collagenase clostridium histolyticum): 2 concurrent 0.58 mg injections (1 injection per joint) in the same hand
734477|NCT01674621|B6|Baseline|Total|Total of all reporting groups
734478|NCT01674621|B5|Baseline|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
734479|NCT01674621|B4|Baseline|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
734480|NCT01674621|B3|Baseline|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
734481|NCT01674621|B2|Baseline|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
734482|NCT01674621|B1|Baseline|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
734483|NCT01674621|P5|Participant Flow|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
734484|NCT01674621|P4|Participant Flow|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
734485|NCT01674621|P3|Participant Flow|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
734489|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
734490|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
734491|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
734499|NCT01674621|O4|Outcome|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
734500|NCT01674621|O3|Outcome|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
734501|NCT01674621|O2|Outcome|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
734502|NCT01674621|O1|Outcome|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
734503|NCT01674621|E5|Reported Event|BA058 (Abaloparatide) Injection (80 mcg)|"BA058 (abaloparatide-SC) Subcutaneous Injection - 80 mcg daily~BA058 Injection (80 mcg): BA058 Subcutaneous Injection, 80 mcg, daily injections for 6 months"
734504|NCT01674621|E4|Reported Event|BA058 (Abaloparatide) Transdermal (150 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 150 mcg daily~BA058 Transdermal (150 mcg): BA058 Transdermal Microneedle Active Patch, 150 mcg, daily applications for 6 months"
734505|NCT01674621|E3|Reported Event|BA058 (Abaloparatide) Transdermal (100 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch - 100 mcg daily~BA058 Transdermal (100 mcg): BA058 Transdermal Microneedle Active Patch, 100 mcg, daily applications for 6 months"
734506|NCT01674621|E2|Reported Event|BA058 (Abaloparatide) Transdermal (50 mcg)|"BA058 (abaloparatide)Transdermal Microneedle Patch - 50 mcg daily~BA058 Transdermal (50 mcg): BA058 Transdermal Microneedle Active Patch, 50 mcg, daily applications for 6 months"
734507|NCT01674621|E1|Reported Event|BA058 (Abaloparatide) Transdermal Placebo (0 mcg)|"BA058 (abaloparatide) Transdermal Microneedle Patch 0 mcg daily~BA058 Placebo: BA058 Transdermal Microneedle Placebo Patch, 0 mcg, daily applications for 6 months"
734508|NCT01674062|B3|Baseline|Total|Total of all reporting groups
734509|NCT01674062|B2|Baseline|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
734510|NCT01674062|B1|Baseline|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734511|NCT01674062|P2|Participant Flow|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
734512|NCT01674062|P1|Participant Flow|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via intravenous (IV) infusion as 2 milligrams per kilogram (mg/kg) once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 milligrams (mg) followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734513|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734554|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734514|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734560|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734515|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734516|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734517|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734518|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734519|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734520|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
734521|NCT01674062|O1|Outcome|Pertuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. The treatment regimen was maintained until disease progression, intolerable toxicity, death, and/or transition to dual-agent therapy with trastuzumab.
734522|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734555|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734587|NCT01673919|E1|Reported Event|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734588|NCT01673867|B3|Baseline|Total|Total of all reporting groups
734523|NCT01674062|O1|Outcome|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734524|NCT01674062|E2|Reported Event|Pertuzumab +/- Trastuzumab (Cohort 3)|Females with HER2-positive metastatic breast cancer received single-agent treatment with pertuzumab. Recruitment for Cohort 3 was conducted following primary analysis of Cohorts 1 and 2. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, administered on Day 1 of each 3-week cycle. Participants with documented disease progression could have trastuzumab added to the regimen, per the dosing schedule described for Cohorts 1 and 2, to receive dual-agent treatment until disease progression, intolerable toxicity, or death.
734561|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734525|NCT01674062|E1|Reported Event|Pertuzumab + Trastuzumab (Cohorts 1 and 2)|Females with HER2-positive metastatic breast cancer received dual-agent treatment with pertuzumab and trastuzumab. Recruitment for Cohorts 1 and 2 was conducted separately; however, the same regimen was administered to both sets of participants. Trastuzumab was administered via IV infusion as 2 mg/kg once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1. Pertuzumab was administered via IV infusion at a loading dose of 840 mg followed by a standard dose of 420 mg every 3 weeks, beginning on Day 2 of Cycle 1. Thereafter, both medications were administered on Day 1 of each 3-week cycle. Treatment continued for a minimum of 8 cycles and could be extended until disease progression, intolerable toxicity, or death.
734526|NCT01674010|B1|Baseline|All Study Participants|
734527|NCT01674010|P3|Participant Flow|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
734528|NCT01674010|P2|Participant Flow|Phase 2 Placebo|Double Blind Randomization (Phase 2)
734529|NCT01674010|P1|Participant Flow|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
734530|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
734531|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
734532|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
734533|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
734534|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
734535|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
734536|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
734537|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
734538|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
734539|NCT01674010|O3|Outcome|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
734540|NCT01674010|O2|Outcome|Phase 2 Placebo|Double Blind Randomization (Phase 2)
734541|NCT01674010|O1|Outcome|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
734542|NCT01674010|E3|Reported Event|Phase 2 ELND005 500 mg BID|Randomization Phase 2 ELND005 500 mg BID
734543|NCT01674010|E2|Reported Event|Phase 2 Placebo|Double Blind Randomization (Phase 2)
734544|NCT01674010|E1|Reported Event|Open Treatment Phase 1 ELND005 500 mg BID|ELND005 500mg BID for 16 weeks
734545|NCT01673984|B3|Baseline|Total|Total of all reporting groups
734546|NCT01673984|B2|Baseline|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734547|NCT01673984|B1|Baseline|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734548|NCT01673984|P2|Participant Flow|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734549|NCT01673984|P1|Participant Flow|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734550|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734551|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734552|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734553|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734586|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734556|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734557|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734558|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734559|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734562|NCT01673984|O2|Outcome|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734563|NCT01673984|O1|Outcome|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734564|NCT01673984|E2|Reported Event|Current 3-monthly LHRH Agonist|"One of the following: Decapeptyl® SR 11.25mg, Prostap® 3 DCS 11.25mg, Zoladex® LA 10.8mg~Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg: For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall"
734565|NCT01673984|E1|Reported Event|Decapeptyl® SR 22.5mg|Decapeptyl® SR 22.5mg: 22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
734566|NCT01673919|B1|Baseline|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734567|NCT01673919|P1|Participant Flow|Tocilizumab (8 mg/kg)|Eligible participants received tocilizumab (TCZ) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA) in France, whichever came first.
734568|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734569|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734570|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734571|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734572|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734573|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734574|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734575|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734576|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734577|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734578|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734579|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734580|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734581|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734582|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734583|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734584|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734585|NCT01673919|O1|Outcome|Tocilizumab (8 mg/kg)|Eligible participants received TCZ 8 mg/kg intravenously every 4 weeks up to 104 weeks or until TCZ was commercially available for pcJIA in France, whichever came first.
734589|NCT01673867|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734590|NCT01673867|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734591|NCT01673867|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734592|NCT01673867|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734593|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734594|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734595|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734596|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734597|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734598|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734599|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734600|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734601|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734602|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734603|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734604|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734605|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734606|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734607|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734608|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734609|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734610|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734611|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734612|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734613|NCT01673867|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734614|NCT01673867|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734615|NCT01673867|E2|Reported Event|NIVOLUMAB 3 mg/kg|Nivolumab 3 mg/kg solution intravenously (IV) every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734616|NCT01673867|E1|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 concentrate for solution for intravenous (IV) infusion every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
734617|NCT01673854|B1|Baseline|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
734618|NCT01673854|P1|Participant Flow|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
734619|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
734620|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
734621|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
734622|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
734623|NCT01673854|O1|Outcome|Vemurafenib, 960 mg + Ipilimumab, 10 mg/kg|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity. Following the end-of-treatment visit, patients entered the Follow-up Phase.
734624|NCT01673854|E1|Reported Event|Vemurafenib, 960 mg + Ipilimumab,10 mg/kg ab|Participants received vemurafenib, 960 mg, twice daily for 6 weeks (Vem1 Phase). After a washout period of 3-10 days, patients received ipilimumab, 10 mg/kg, every 3 weeks for a maximum of 4 doses. At Week 24, participants received ipilimumab, 10 mg/kg, every 12 weeks until disease progression or unacceptable toxicity. Patients who did not progress or have unacceptable toxicity in the Vem1 Phase were retreated with vemurafenib (Vem 2 Phase) at the last dose level identified at the end of the Vem1 Phase until disease progression or unacceptable toxicity.
734625|NCT01673802|B1|Baseline|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
734626|NCT01673802|P1|Participant Flow|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
734627|NCT01673802|O1|Outcome|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
734668|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
734669|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
734628|NCT01673802|E1|Reported Event|Gadoxetate Uptake in CT Imaging|Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
734629|NCT01673698|B3|Baseline|Total|Total of all reporting groups
734630|NCT01673698|B2|Baseline|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
734631|NCT01673698|B1|Baseline|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
734632|NCT01673698|P2|Participant Flow|Sham Comparator|"Sham Comparator~Diet counseling~Exercise counseling"
736585|NCT01665170|O1|Outcome|Verum|Verum arm - Pascoflair 425mg
734633|NCT01673698|P1|Participant Flow|ReShape Duo Balloon|"ReShape Duo Balloon~ReShape Duo balloon~Diet counseling~Exercise counseling"
734634|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
734635|NCT01673698|O1|Outcome|Intent-to-Treat|Intent-to-Treat population
734636|NCT01673698|O2|Outcome|Control|Control group
734637|NCT01673698|O1|Outcome|Treatment|Treatment group
734638|NCT01673698|E2|Reported Event|Control Subjects|Subjects who were randomized to diet and exercise counseling only during weeks 0-24
734639|NCT01673698|E1|Reported Event|Treatment Subjects|Subjects who were randomized and received a balloon during weeks 0-24
734640|NCT01673620|B3|Baseline|Total|Total of all reporting groups
734641|NCT01673620|B2|Baseline|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
734642|NCT01673620|B1|Baseline|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
734643|NCT01673620|P2|Participant Flow|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
734644|NCT01673620|P1|Participant Flow|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
734645|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
734646|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
734647|NCT01673620|O2|Outcome|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
734648|NCT01673620|O1|Outcome|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
734649|NCT01673620|E2|Reported Event|Placebo|Participants receive matching placebo tablets once daily for 2 weeks
734650|NCT01673620|E1|Reported Event|Montelukast 10 mg/Loratadine 10 mg|Participants receive montelukast 10 mg/loratadine 10 mg combination tablets once daily for 2 weeks
734651|NCT01673594|B3|Baseline|Total|Total of all reporting groups
734652|NCT01673594|B2|Baseline|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
734653|NCT01673594|B1|Baseline|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
734654|NCT01673594|P2|Participant Flow|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
734655|NCT01673594|P1|Participant Flow|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
734656|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
734657|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
734658|NCT01673594|O2|Outcome|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
734659|NCT01673594|O1|Outcome|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
734660|NCT01673594|E2|Reported Event|Placebo|"Arm 2: Placebo + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH"
734661|NCT01673594|E1|Reported Event|Naltrexone|"Arm 1: Naltrexone + SODAS MPH~SODAS MPH: Adults with ADHD will receive open-label SODAS MPH~Naltrexone: Subjects randomized to the active double-blind group will receive Naltrexone HCl"
734662|NCT01673568|B3|Baseline|Total|Total of all reporting groups
734663|NCT01673568|B2|Baseline|no Abdominal Binder|no abdominal binder was warn
734664|NCT01673568|B1|Baseline|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
734665|NCT01673568|P2|Participant Flow|no Abdominal Binder|no abdominal binder
734666|NCT01673568|P1|Participant Flow|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
734667|NCT01673568|O2|Outcome|no Abdominal Binder|no abdominal binder
734691|NCT01673347|P1|Participant Flow|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
734670|NCT01673568|O1|Outcome|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
734671|NCT01673568|E2|Reported Event|no Abdominal Binder|no abdominal binder
734696|NCT01673347|E1|Reported Event|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
734697|NCT01673282|B3|Baseline|Total Title|
735265|NCT01671605|P2|Participant Flow|Controls|Controls with normal kidney function (Control)
734672|NCT01673568|E1|Reported Event|Abdominal Binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days, night and day. The belts are standard elastic belts (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done before the operation by waist measurement according to the recommendation from the company.~ETO garments: patients wearing abdominal binder for 7 days postoperatively"
734673|NCT01673490|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734674|NCT01673490|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734675|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734676|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734677|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734678|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734679|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734680|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734681|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734682|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734683|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734684|NCT01673490|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734685|NCT01673490|E1|Reported Event|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Participants received a combination of 0.5 mg dutasteride and 0.4 mg tamsulosin capsule orally approximately 30 minutes after a meal once daily for 6 months during the treatment period. Participants were followed up to 30 days after the last dose of study medication to evaluate the safety profile of study drug.
734686|NCT01673425|B1|Baseline|Live Attenuated Influenza Vaccine Study|This study was terminated due to poor enrollment and inconclusive nasal wash samples. No analyses were performed.
734687|NCT01673425|P1|Participant Flow|Experimental: Live Attenuated Influenza Vaccine|Single intervention study; all participants receive LAIV
734688|NCT01673425|O1|Outcome|Experimental: Live Attenuated Influenza Vaccine|Single Intervention Study
734689|NCT01673425|E1|Reported Event|Study Enrollment|Low accrual. Only 4 subjects completed study in 2 month period. Study terminated.
734690|NCT01673347|B1|Baseline|MENISCAL ALLOGRAFT|"The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe.~Meniscal Allograft: Meniscal allograft"
734692|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
734693|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
734694|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
734695|NCT01673347|O1|Outcome|MENISCAL ALLOGRAFT|The meniscal allograft is taken from the meniscal knee joint and implanted surgically in to the great toe for treatment of metatarsophalangeal (MTP) osteoarthritis.
734698|NCT01673282|B2|Baseline|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
734699|NCT01673282|B1|Baseline|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
734700|NCT01673282|P2|Participant Flow|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
734701|NCT01673282|P1|Participant Flow|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
734702|NCT01673282|O2|Outcome|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
734703|NCT01673282|O1|Outcome|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
734704|NCT01673282|E2|Reported Event|Vimpat + Non-Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs), none of which is a sodium channel blocking AED.
734705|NCT01673282|E1|Reported Event|Vimpat + Na Channel Blocking AED|Patients prescribed adjunctive lacosamide (LCM) added to one or more baseline Anti-Epileptic Drugs (AEDs) to include at least 1 sodium channel blocking AED.
734706|NCT01673256|B1|Baseline|SJM Confirm ICM Observational Group|SJM Confirm ICM
734707|NCT01673256|P1|Participant Flow|SJM Confirm ICM Observational Group|SJM Confirm ICM
734708|NCT01673256|O1|Outcome|SJM Confirm ICM Observational Group|SJM Confirm ICM
734709|NCT01673256|E1|Reported Event|SJM Confirm ICM Observational Group|SJM Confirm ICM
734710|NCT01673191|B3|Baseline|Total|Total of all reporting groups
734711|NCT01673191|B2|Baseline|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734712|NCT01673191|B1|Baseline|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734713|NCT01673191|P2|Participant Flow|Steroid Plus NSAID Eye Drop Combination Therapy|"NSAID eye drop: Acular LS Steriod eye drop: Pred Forte~Steroid plus NSAID eye drop combination therapy"
734714|NCT01673191|P1|Participant Flow|OZURDEX Intraocular Implant|"OZURDEX (dexamethasone posterior segment drug delivery system (DEX PS DDS), 0.7 mg~Dexamethasone intravitreal implant"
734715|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734716|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734717|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734718|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734719|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734735|NCT01673178|B2|Baseline|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734736|NCT01673178|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734737|NCT01673178|P5|Participant Flow|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734738|NCT01673178|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734720|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734721|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734722|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734723|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734724|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734725|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734726|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734727|NCT01673191|O2|Outcome|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734728|NCT01673191|O1|Outcome|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734729|NCT01673191|E2|Reported Event|Topical Steroid/NSAID ARM|Subjects randomized to receive the steroid/NSAID eye drop combination therapy began treatment at Day 0. The first administration occurred in clinic. Subjects was instructed how to instill eye drops properly and to instill each drop in the study eye four times per day every day until month 1 visit. At each monthly visit, subjects in this arm were assessed for the need to continue steroid/NSAID therapy.
734730|NCT01673191|E1|Reported Event|DEX IMPLANT ARM|Subects in the DEX implant arm received a single intravitreal administration of 0.7 mg OZURDEX in the study eye at the Day 0 appointment. In order to minimize subject discomfort, adequate local anesthesia was administered to the study eye prior to DEX implant injection. Immediately following DEX implant injection, the investigator performed indirect ophthalmic exam to assess for complications. In order to minimize risk of infection, a topical broad-spectrum antibiotic was placed in the study eye immediately prior to and following the injection, and the subject were provided a sample of a broad-spectrum antibiotic to use 4 times daily for 3 days following injection. The subject remained in the clinic for 15-30 minutes or until IOP <28 mmHg.
734731|NCT01673178|B6|Baseline|Total|Total of all reporting groups
734732|NCT01673178|B5|Baseline|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734733|NCT01673178|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734734|NCT01673178|B3|Baseline|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
735266|NCT01671605|P1|Participant Flow|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
734739|NCT01673178|P3|Participant Flow|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734740|NCT01673178|P2|Participant Flow|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734741|NCT01673178|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734742|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734743|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734744|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734745|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734746|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734747|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734748|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734749|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734750|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734751|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734752|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734753|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734754|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734755|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734756|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734757|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734758|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734759|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734760|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734761|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734762|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734763|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734764|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734765|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734766|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734767|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734768|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734769|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734770|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734771|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734772|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734773|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734774|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734775|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734776|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734777|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734778|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734779|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734780|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734781|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734782|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734783|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734784|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734785|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734786|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734787|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734788|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
735267|NCT01671605|O2|Outcome|Controls|Controls with normal kidney function (Control)
734789|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734790|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734791|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734792|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734793|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734794|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734795|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734796|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734797|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734798|NCT01673178|O4|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734799|NCT01673178|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734800|NCT01673178|O2|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734801|NCT01673178|O1|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734802|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734803|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734804|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734805|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734806|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734807|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734808|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734809|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734810|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734811|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734812|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734813|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734814|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734815|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734816|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734817|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734818|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734819|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734820|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734821|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734822|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734823|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734824|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734825|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734826|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734827|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734828|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734829|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734830|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734831|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734832|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734833|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734834|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734835|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734836|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734837|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734838|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
735268|NCT01671605|O1|Outcome|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
734839|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734840|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734841|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734842|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734843|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734844|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734845|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734846|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734847|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734848|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734849|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734850|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734851|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734852|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734853|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734854|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734855|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734856|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734857|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734858|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734859|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734860|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734861|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734862|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734863|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734864|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734865|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734866|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734867|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734868|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734869|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734870|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734871|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734872|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734873|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734874|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734875|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734876|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734877|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734878|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734879|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734880|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734881|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734882|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734883|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734884|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734885|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734886|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734887|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734888|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
736586|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
734889|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734890|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734891|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734892|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734893|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734894|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734895|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734896|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734897|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734898|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734899|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734900|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734901|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734902|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734903|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734904|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734905|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734906|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734907|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734908|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734909|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734910|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734911|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734912|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734913|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734914|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734915|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734916|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734917|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734918|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734919|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734920|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734921|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734922|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734923|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734924|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734925|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734926|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734927|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734928|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734929|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734930|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734931|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734932|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734933|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734934|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734935|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734936|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734937|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734938|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
736587|NCT01665170|O1|Outcome|Placebo|Placebo arm
734939|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734940|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734941|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734942|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734943|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734944|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734945|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734946|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734947|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734948|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734949|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734950|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734951|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734952|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734953|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734954|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734955|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734956|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734957|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734958|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734959|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734960|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734961|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734962|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734963|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734964|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734965|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734966|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734967|NCT01673178|O5|Outcome|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734968|NCT01673178|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734969|NCT01673178|O3|Outcome|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734970|NCT01673178|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734971|NCT01673178|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734972|NCT01673178|E5|Reported Event|PF-05231023 150 mg|PF-05231023 150 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734973|NCT01673178|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734974|NCT01673178|E3|Reported Event|PF-05231023 50 mg|PF-05231023 50 mg intravenous infusion over 30 minutes once weekly up to Week 4.
734975|NCT01673178|E2|Reported Event|PF-05231023 25 mg|PF-05231023 25 milligram (mg) intravenous infusion over 30 minutes once weekly up to Week 4.
734976|NCT01673178|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over 30 minutes once weekly up to Week 4.
734977|NCT01673126|B3|Baseline|Total|Total of all reporting groups
734978|NCT01673126|B2|Baseline|Sham tDCS First|Patients received sham tDCS during 20 minutes. Then, washout of 2days. Then andoal tDCS.
734979|NCT01673126|B1|Baseline|Anodal tDCS First|Patients received anodal tDCS during 20 minutes. Then, washout of 2days. Then sham tDCS.
809576|NCT01362517|O1|Outcome|Quinvaxem|
734980|NCT01673126|P2|Participant Flow|Sham tDCS|Sham tDCS during first, then 2 days of washout, then anodal tDCS.
734981|NCT01673126|P1|Participant Flow|Anodal tDCS|Anodal tDCS (on DLPF cortex) first, hen 2 days of washout, then sham tDCS.
734982|NCT01673126|O2|Outcome|Sham tDCS First|"Patients received sham tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then anodal tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
734983|NCT01673126|O1|Outcome|Anodal tDCS First|"Patients received anodal tDCS first during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised).~Then, a washout period (2days). Then sham tDCS during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)."
734984|NCT01673126|E2|Reported Event|Sham tDCS|"Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.~sham tDCS: Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation."
736588|NCT01665170|E2|Reported Event|Verum|Verum arm - Pascoflair 425mg
734985|NCT01673126|E1|Reported Event|Anodal tDCS|"Patients received anodal tDCS (on DLPF cortex) during 20 minutes preceded and followed by a clinical assessment (Coma Recovery Scale-Revised)~Anodal tDCS: patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)"
734986|NCT01673113|B3|Baseline|Total|Total of all reporting groups
734987|NCT01673113|B2|Baseline|Control|The untreated flank of each subject served as the internal control.
734988|NCT01673113|B1|Baseline|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
734989|NCT01673113|P2|Participant Flow|Control|The untreated flank of each subject served as internal control.
734990|NCT01673113|P1|Participant Flow|Treatment|Subjects were randomized to have either left or right flank treated with cryolipolysis.
734991|NCT01673113|O2|Outcome|Control|The untreated flank of each subject served as the internal control.
734992|NCT01673113|O1|Outcome|Treatment|Subjects were randomized to have right or left flank treated with Zeltiq CoolSculpting device
734993|NCT01673113|O2|Outcome|Control|Untreated flanks of each subject had vibration sensory testing done within 48-72 hours after treatment.
734994|NCT01673113|O1|Outcome|Treatment|Cryolipolysis treated flanks had vibration sensory testing done within 48-72 hours after treatment.
734995|NCT01673113|E1|Reported Event|Cryolipolysis|Zeltiq CoolSculpting device: This is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks, an area commonly referred to as the “love handles.”
734996|NCT01673009|B1|Baseline|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
734997|NCT01673009|P1|Participant Flow|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
734998|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
734999|NCT01673009|O1|Outcome|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
735000|NCT01673009|E1|Reported Event|Administration of Gleevec|"Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.~Gleevec: Gleevec® will be dosed orally 440 mg/m2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients."
735001|NCT01672996|B8|Baseline|Total|Total of all reporting groups
735002|NCT01672996|B7|Baseline|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735003|NCT01672996|B6|Baseline|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
735004|NCT01672996|B5|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
735005|NCT01672996|B4|Baseline|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735006|NCT01672996|B3|Baseline|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
735007|NCT01672996|B2|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
735008|NCT01672996|B1|Baseline|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
735009|NCT01672996|P3|Participant Flow|Arm 3 - Iopamidol 300mgI/mL|"Given as a single administration to the subject~Iopamidol 300 mgI/mL: Given as a single administration to the subject"
735010|NCT01672996|P2|Participant Flow|Arm 2 - Ioforminol 200mgI/mL|"Given as a single administration to the subject~Ioforminol 200 mgI/mL: Given as a single administration to the subject"
735011|NCT01672996|P1|Participant Flow|Arm 1 - Ioforminol 160mgI/mL|"Single administration of Ioforminol 160mgI/mL given to the subject.~Ioforminol 160 mgI/mL: Given as s single administration to the subject"
735012|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735013|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
735014|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
736186|NCT01667796|O2|Outcome|Healthy Controls|Female subjects without MS
735015|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735016|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
735017|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
735018|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
735019|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735020|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
735021|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
735022|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
736589|NCT01665170|E1|Reported Event|Placebo|Placebo arm
735023|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
735024|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
735025|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
735026|NCT01672996|O7|Outcome|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735027|NCT01672996|O6|Outcome|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
735028|NCT01672996|O5|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
735029|NCT01672996|O4|Outcome|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735030|NCT01672996|O3|Outcome|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
735031|NCT01672996|O2|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
735032|NCT01672996|O1|Outcome|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
735033|NCT01672996|E7|Reported Event|Arm 3 - Iopamidol 300mgI/mL-1.0mL/Kg|"Iopamidol 300 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735034|NCT01672996|E6|Reported Event|Arm 2 - Ioforminol 200mgI/mL-2.0mL/Kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 2.0mL/Kg"
735035|NCT01672996|E5|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.5mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.5mL/Kg"
735036|NCT01672996|E4|Reported Event|Arm 2 - Ioforminol 200mgI/mL-1.0mL/kg|"Ioforminol 200 mgI/mL: Given as a single administration to the subject.~Dosing the Subject at 1.0mL/Kg"
735037|NCT01672996|E3|Reported Event|Arm 1 - Ioforminol 160mgI/mL-2.0mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 2.0mL/kg."
735038|NCT01672996|E2|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.5mL/Kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.5mL/kg."
735039|NCT01672996|E1|Reported Event|Arm 1 - Ioforminol 160mgI/mL-1.0mL/kg|"Ioforminol 160 mgI/mL: Given as s single administration to the subject.~Dosing the Subject at 1.0mL/kg."
735040|NCT01672983|B7|Baseline|Total|Total of all reporting groups
735041|NCT01672983|B6|Baseline|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735042|NCT01672983|B5|Baseline|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735043|NCT01672983|B4|Baseline|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735044|NCT01672983|B3|Baseline|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735045|NCT01672983|B2|Baseline|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735046|NCT01672983|B1|Baseline|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735047|NCT01672983|P6|Participant Flow|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735048|NCT01672983|P5|Participant Flow|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735049|NCT01672983|P4|Participant Flow|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735050|NCT01672983|P3|Participant Flow|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735051|NCT01672983|P2|Participant Flow|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735052|NCT01672983|P1|Participant Flow|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735053|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735054|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735055|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735056|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735057|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735058|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735059|NCT01672983|O6|Outcome|Arm 6|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
735060|NCT01672983|O5|Outcome|Arm 5|Hepatitis C Virus (HCV), genotype 2 (GT2) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
735061|NCT01672983|O4|Outcome|Arm 4|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
735062|NCT01672983|O3|Outcome|Arm 3|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 24 weeks.
735063|NCT01672983|O2|Outcome|Arm 2|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 150/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
735064|NCT01672983|O1|Outcome|Arm 1|Hepatitis C Virus (HCV), genotype 1b (GT1b) participants received 100/100 mg ABT-450/ribavirin and 25 mg ABT-267 daily for 12 weeks.
735269|NCT01671605|E2|Reported Event|Controls|Controls with normal kidney function (Control)
735065|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735066|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735067|NCT01672983|O2|Outcome|Arm 2 + Arm 6|Arm 2: Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 6: Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735068|NCT01672983|O1|Outcome|Arm 1 + Arm 5|Arm 1: Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks; Arm 5: Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735069|NCT01672983|O6|Outcome|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735070|NCT01672983|O5|Outcome|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735071|NCT01672983|O4|Outcome|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735072|NCT01672983|O3|Outcome|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735073|NCT01672983|O2|Outcome|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735074|NCT01672983|O1|Outcome|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735075|NCT01672983|E6|Reported Event|Arm 6|Participants with HCV GT2 received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735076|NCT01672983|E5|Reported Event|Arm 5|Participants with HCV GT2 received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735077|NCT01672983|E4|Reported Event|Arm 4|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735078|NCT01672983|E3|Reported Event|Arm 3|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 24 weeks.
735079|NCT01672983|E2|Reported Event|Arm 2|Participants with HCV GT1b received ABT-450/ritonavir (150/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735080|NCT01672983|E1|Reported Event|Arm 1|Participants with HCV GT1b received ABT-450/ritonavir (100/100 mg) and ABT-267 (25 mg) once daily for 12 weeks.
735081|NCT01672970|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735082|NCT01672970|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria, in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735083|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735084|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735085|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735086|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735087|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735088|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735089|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735090|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735091|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735092|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735093|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735094|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735095|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735096|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735097|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735098|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735099|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735100|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735101|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735102|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735103|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735104|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735105|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735106|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735107|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735108|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735109|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735110|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735111|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735112|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735812|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
735113|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735114|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735115|NCT01672970|O1|Outcome|RA Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735116|NCT01672970|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria, in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
735130|NCT01672827|B1|Baseline|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to evaluate the effectiveness of an electronic training program for orienting and interpreting Flutemetamol Positive Emission Tomography (PET) Images.
736590|NCT01665157|B4|Baseline|Total|Total of all reporting groups
735117|NCT01672957|B1|Baseline|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735118|NCT01672957|P1|Participant Flow|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil (CellCept), were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC). The study protocol did not specify any treatment regimen.
735119|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735120|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735121|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735122|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735123|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735124|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735125|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735126|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735127|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735128|NCT01672957|O1|Outcome|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735129|NCT01672957|E1|Reported Event|Renal Transplant Participants|Renal transplant participants who were subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, were followed-up until the end of the study (after 12 months), or until the participant’s death, withdrawal, or lost contact with the participant, whichever occurred first. The choice of treatment was made prior to enrollment by the treating physician. The treatment was administered according to applicable therapeutic protocol and SmPC. The study protocol did not specify any treatment regimen.
735131|NCT01672827|P1|Participant Flow|[18F]Flutemetamol|No subjects were dosed for this study. Product was used in scans previously acquired in various GE-067 studies. This study was designed to show the PET Image Interpretations among investigators. The study did not enroll the blinded image Readers.
735132|NCT01672827|O1|Outcome|Specificity %|Specificity of the blinded visual PET Image Interpretations without Anatomic Images.
735133|NCT01672827|O1|Outcome|Inter-Reader Agreement|Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images.
735134|NCT01672827|O1|Outcome|Sensitivity %|Sensitivity of the blinded visual PET Image Interpretations without Anatomic Images.
735135|NCT01672827|E1|Reported Event|[18F]Flutemetamol|No adverse event data collected because no subjects were dosed in this study , therefore no subjects were at risk.
735136|NCT01672788|B1|Baseline|Overall Study|Total number of patients randomised and treated in the study. This was an open-label, randomized, 4-way crossover trial. 36 patients were randomised to one of 4 treatment sequences and treated. Each treatment period consisted of a single dose of medication followed by 72hours of pharmacokinetic sampling, with a washout of at least 7 days between treatment periods.
735137|NCT01672788|P4|Participant Flow|R2 / T2 / R1 / T1|"Patients received the 4 treatments in the following order:~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)"
735138|NCT01672788|P3|Participant Flow|T2 / R2 / T1 / R1|"Patients received the 4 treatments in the following order:~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)"
735139|NCT01672788|P2|Participant Flow|R1 / T1 / R2 / T2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)"
735140|NCT01672788|P1|Participant Flow|T1 / R1 / T2 / R2|"Patients received the 4 treatments in the following order:~Empa 12.5mg Fixed-dose: Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin (T1)~Empa 12.5mg Free Dose: Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet) (R1)~Empa 5mg Fixed-dose: Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin (T2)~Empa 5mg Free Dose: Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet) (R2)"
735141|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
735142|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
735143|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
735144|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
735145|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
735146|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
735147|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
735148|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
735149|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
735150|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
735151|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
735152|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
735153|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
735154|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
736187|NCT01667796|O1|Outcome|MS Subjects|Female subjects with MS
735155|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
735156|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
735157|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
735158|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
735159|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
735160|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
735161|NCT01672788|O4|Outcome|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
735162|NCT01672788|O3|Outcome|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
735163|NCT01672788|O2|Outcome|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
735164|NCT01672788|O1|Outcome|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
735165|NCT01672788|E4|Reported Event|Empa 5mg Free Dose|Free dose combination of 5mg empagliflozin (1 tablet) and 850mg metformin (1 tablet)
745848|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
735166|NCT01672788|E3|Reported Event|Empa 5mg Fixed-dose|Fixed-dose tablet of 5mg empagliflozin plus 850mg metformin
735167|NCT01672788|E2|Reported Event|Empa 12.5mg Free Dose|Free dose combination of 12.5mg empagliflozin (consisting of 1 tablet of 10mg and another of 2.5mg) and 850mg metformin (1 tablet)
735168|NCT01672788|E1|Reported Event|Empa 12.5mg Fixed-dose|Fixed-dose tablet of 12.5mg empagliflozin plus 850mg metformin
735169|NCT01672723|B1|Baseline|Naltrexone First and Placebo First|Includes groups randomized to receive naltrexone first and placebo first.
735170|NCT01672723|P2|Participant Flow|Placebo First, Then Naltrexone|Participants took 4 placebo pills over 4 days (one pill a day), followed by a 10-day washout period, followed by 4 naltrexone pills for 4 days (25 mg on days 1 and 2, 50mg on days 3 and 4)
735171|NCT01672723|P1|Participant Flow|Naltrexone First, Then Placebo|Participants took 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) followed by a 10-day washout period and finally, 4 matched placebo pills for another 4 days.
735172|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
735173|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
735174|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
735175|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
735176|NCT01672723|O2|Outcome|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
735177|NCT01672723|O1|Outcome|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure.~Naltrexone"
735178|NCT01672723|E2|Reported Event|Placebo|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
813180|NCT01349829|O2|Outcome|Havrix|
735179|NCT01672723|E1|Reported Event|Naltrexone|"Participants will take 4 doses of naltrexone over 4 days (25mg/day for days 1 and 2, 50mg/day for days 3 and 4) as well as 4 matched placebo pills for a total of 8 days. Capsules will be packaged into blister packs.~Participants will be asked to take the first drug, either naltrexone or placebo, once a day for three days prior to the first experimental session and when they arrive at the lab for the experimental procedure . After the first session, participants will take the second study drug for three days prior to the second experimental session and when they arrive for the second experimental procedure."
735180|NCT01672658|B3|Baseline|Total|Total of all reporting groups
735181|NCT01672658|B2|Baseline|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735182|NCT01672658|B1|Baseline|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735235|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
745849|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
735183|NCT01672658|P2|Participant Flow|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735184|NCT01672658|P1|Participant Flow|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735185|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735186|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735187|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735188|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735189|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735190|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735191|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735192|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735193|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735194|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735195|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735224|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
736555|NCT01665170|O1|Outcome|Placebo|Placebo arm
735196|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735197|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735198|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735199|NCT01672658|O2|Outcome|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735200|NCT01672658|O1|Outcome|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735264|NCT01671605|B1|Baseline|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
735201|NCT01672658|E2|Reported Event|Traditional Vestibular Rehabilitation|"Traditional vestibular rehabilitation will include VOT exercises that will work toward increasing the gain of the system as well as walking, balance re-training, and functional mobility.~Traditional Vestibular Rehabilitation: Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility."
735202|NCT01672658|E1|Reported Event|Sensory Kinectics Balance System|"Subjects will be randomized in to one of two groups. The group that will receive training on the SKBS device along with traditional vestibular and balance training.~Sensory Kinetics Balance System: Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks."
735203|NCT01672294|B5|Baseline|Total|Total of all reporting groups
735204|NCT01672294|B4|Baseline|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD..
735205|NCT01672294|B3|Baseline|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
735206|NCT01672294|B2|Baseline|Caregiver Outlook - Patient|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
735207|NCT01672294|B1|Baseline|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Topics included life review, issues of forgiveness and heritage and legacy.
735208|NCT01672294|P4|Participant Flow|Relaxation Meditation - Patient|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
735209|NCT01672294|P3|Participant Flow|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
735210|NCT01672294|P2|Participant Flow|Caregiver Outlook - Patient|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Topics included life review, issues of forgiveness and heritage and legacy."
735211|NCT01672294|P1|Participant Flow|Caregiver Outlook - Caregiver|"Intervention: Three facilitator-led preparation and life completion sessions with caregiver. Intervention: Three facilitator-led preparation and life completion sessions with caregiver.~Topics included life review, issues of forgiveness and heritage and legacy."
735212|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
735213|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
735214|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
735215|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
735216|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
735217|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
735218|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
735219|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
735220|NCT01672294|O2|Outcome|Relaxation Meditation - Patient|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
735221|NCT01672294|O1|Outcome|Caregiver Outlook - Patient|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
735222|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
735223|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
736556|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
735225|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
735226|NCT01672294|O2|Outcome|Relaxation Meditation - Caregiver|Three facilitator-led sessions of caregivers listening to a non-guided relaxation CD (Attention Control).
735227|NCT01672294|O1|Outcome|Caregiver Outlook - Caregiver|Three facilitator-led preparation and completion sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy (Intervention).
735228|NCT01672294|E4|Reported Event|Relaxation Meditation - Patient|Patients of the caregivers in the Attention Control arm.
735229|NCT01672294|E3|Reported Event|Relaxation Meditation - Caregiver|Attention Control: Three facilitator led sessions of caregivers listening to a non-guided relaxation CD.
735230|NCT01672294|E2|Reported Event|Caregiver Outlook - Patient|Patients of the caregivers in the Outlook Intervention arm.
735231|NCT01672294|E1|Reported Event|Caregiver Outlook - Caregiver|Intervention: Three facilitator-led sessions with the caregiver discussing life review, issues of forgiveness and heritage and legacy.
735232|NCT01671839|B1|Baseline|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735233|NCT01671839|P1|Participant Flow|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735234|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735236|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735237|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735238|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735239|NCT01671839|O1|Outcome|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735240|NCT01671839|E1|Reported Event|Subcutaneous Tissue Release|"Device: Subcutaneous tissue release with the Cabochon System~Subcutaneous tissue release with the Cabochon System: Device: Subcutaneous tissue release"
735241|NCT01671748|B3|Baseline|Total|Total of all reporting groups
735242|NCT01671748|B2|Baseline|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735243|NCT01671748|B1|Baseline|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735244|NCT01671748|P2|Participant Flow|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735245|NCT01671748|P1|Participant Flow|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735246|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735247|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735248|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735249|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735250|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735251|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735252|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735253|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735254|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735255|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735256|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735257|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735258|NCT01671748|O2|Outcome|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735259|NCT01671748|O1|Outcome|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735260|NCT01671748|E2|Reported Event|NLFU and Standard of Care|Non-contact low frequency ultrasound (NLFU) using MIST ultrasound therapy is applied for between 3 and 12 minutes (depending on wound size) 3 times a week in combination with standard treatment for VLUs of compression bandaging and non-adherent dressing change 3 times a week, with debridement as required.
735261|NCT01671748|E1|Reported Event|Standard of Care|Standard of Care (SOC) was compression bandaging and non-adherent dressing at least once a week (more frequent visits if clinically necessary). Debridement was performed as required.
735262|NCT01671605|B3|Baseline|Total|Total of all reporting groups
735263|NCT01671605|B2|Baseline|Controls|Controls with normal kidney function (Control)
735270|NCT01671605|E1|Reported Event|CKD Not on Dialysis|Patients with CKD not on dialysis (CKD III-IV)
735271|NCT01671488|B1|Baseline|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
735272|NCT01671488|P1|Participant Flow|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
735273|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
735274|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
735275|NCT01671488|O1|Outcome|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
735290|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
735291|NCT01671280|E1|Reported Event|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
813181|NCT01349829|O1|Outcome|HAVpur|
735276|NCT01671488|E1|Reported Event|Treatment|"The first dose will be given 10-14 days prior to the initiation of chemoradiation.~Patient will then receive 5-FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days and Mitomycin: 10 mg/m2, day 1 and 29 with IMRT radiation: 54 Gy in 30 fractions at 1.8 Gy per fraction.~The 2-4th dosages of ADXS11-001 will not be until after completion of all chemoradiation. The second dosage of ADXS11-001 will not be administered until a minimum of 10 days after completion of chemoradiation. The subsequent third and fourth treatment with of ADXS11 will be administered at 28 day intervals.~Treatment: ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.~5FU: 1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days~Mitomycin: 10 mg/m2, day 1 and 29 (day 29 can be + 7 days)~IMRT: 54 Gy in 30 fractions at 1.8 Gy per fraction."
735277|NCT01671293|B3|Baseline|Total|Total of all reporting groups
735278|NCT01671293|B2|Baseline|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
735279|NCT01671293|B1|Baseline|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
735280|NCT01671293|P2|Participant Flow|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
735601|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735281|NCT01671293|P1|Participant Flow|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
735282|NCT01671293|O2|Outcome|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
735283|NCT01671293|O1|Outcome|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
735284|NCT01671293|E2|Reported Event|Usual Care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments.
735285|NCT01671293|E1|Reported Event|Multicomponent Remote Care Model|Multicomponent remote care model: A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer and measuring tape to check waist circumference). The phone counseling was made by professionals working at health centers who have been trained to apply theories on behavioral change and decision-making. A Mean of 5 phone counseling calls were done by participant. Messages were sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- sought to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
735286|NCT01671280|B1|Baseline|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
735287|NCT01671280|P1|Participant Flow|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
735288|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
735289|NCT01671280|O1|Outcome|Zithromac Intravenous Use (Azithromycin Hydrate)|Participants who received Zithromac Intravenous use (and Zithromac Tablets) as indicated in the approved local product document were observed for a period of 29 days. The dosage can be adjusted as per physician’s discretion.
735319|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735292|NCT01671111|B1|Baseline|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735293|NCT01671111|P1|Participant Flow|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 milligram per kilogram per day (mg/kg/day) (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735294|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735295|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735296|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735514|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735297|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735298|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735299|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735300|NCT01671111|O1|Outcome|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735301|NCT01671111|E1|Reported Event|SSP-004184AQ|Participants received SSP-004184AQ (magnesium salt of free acid or active form, that is, SSP-004184 [SPD602, FBS0701]) capsules orally at a total daily dose of 8-75 mg/kg/day (equivalent to SSP-004184 7-68 mg/kg/day) either once daily or twice daily at the discretion of investigator for up to a maximum of 3 years or until the sponsor decided to stop the study.
735302|NCT01671059|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735303|NCT01671059|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735304|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735305|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735306|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735307|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735308|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735309|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735310|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735311|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735312|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735313|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735314|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735315|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735316|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735317|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735318|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
736188|NCT01667796|E2|Reported Event|Healthy Controls|Healthy control subjects
735320|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735321|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735322|NCT01671059|O1|Outcome|Tocilizumab|Participants with RA receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735323|NCT01671059|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735324|NCT01671059|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis (RA) receiving tocilizumab either as combination therapy or monotherapy through routine clinical practice.
735325|NCT01670825|B3|Baseline|Total|Total of all reporting groups
735326|NCT01670825|B2|Baseline|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735327|NCT01670825|B1|Baseline|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735328|NCT01670825|P2|Participant Flow|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735672|NCT01669863|B1|Baseline|Use of ECMO in Non-intubated Patients|ECMO group
836500|NCT01272583|O1|Outcome|Baseline|
735329|NCT01670825|P1|Participant Flow|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735330|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735331|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735332|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735333|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735334|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735335|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735336|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735337|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735338|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735339|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735340|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735341|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735342|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735343|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735344|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
813182|NCT01349829|O2|Outcome|Havrix|
735345|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735346|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735347|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735348|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735349|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735350|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735515|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
737808|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
735351|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735352|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735353|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735354|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735355|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735356|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735357|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735358|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735359|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735360|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735361|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735362|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735363|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735364|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735365|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735366|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735367|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735368|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735369|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735370|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735371|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735372|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735516|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
745850|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
735373|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735374|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735375|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735376|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735377|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735378|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735379|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735380|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735381|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735382|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735383|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735384|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735385|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735386|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735387|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735388|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve~Local anethestic injection"
735389|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve~Local anethestic injection"
735390|NCT01670825|O2|Outcome|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735391|NCT01670825|O1|Outcome|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735392|NCT01670825|E2|Reported Event|Corticosteroid Injection + Sham Pulsed Radiofrequency|"Injection with corticosteroid and local anesthetic over the occipital nerve(s)plus sham pulsed radiofrequency~Corticosteroid injection: Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve"
735393|NCT01670825|E1|Reported Event|Pulsed Radiofrequency + Local Anesthetic Injection|"Local anesthetic injection plus pulsed radiofrequency over each affected occipital nerve~Pulsed radiofrequency: Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve"
735394|NCT01670721|B1|Baseline|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
735395|NCT01670721|P1|Participant Flow|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg intravenous (IV) infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until disease progression (DP), unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
735396|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
735397|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
735398|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
735399|NCT01670721|O1|Outcome|Aflibercept + FOLFIRI (Irinotecan, 5-FU & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment.
735400|NCT01670721|E1|Reported Event|Aflibercept + FOLFIRI(Irinotecan, 5-Fluorouracil & Leucovorin)|Aflibercept 4 mg/kg IV infusion over 60 minutes followed by Irinotecan 180 mg/m^2 IV infusion over 90 minutes and Leucovorin 400 mg/m^2 IV infusion over 120 minutes at the same time followed by 5-FU 400 mg/m^2 IV bolus over 2-4 minutes followed by 5-FU 2400 mg/m^2 continuous IV infusion over 46 hours on Day 1 of each cycle (1 Cycle = 2 weeks), until DP, unacceptable toxicity, death, Investigator's decision or participant's refusal of further treatment (maximum exposure: Week 99).
735401|NCT01670487|B3|Baseline|Total|Total of all reporting groups
735402|NCT01670487|B2|Baseline|Nature's Tears|Applied Nature's Tears in a topical stream of 4 to 10 seconds duration to skin
735403|NCT01670487|B1|Baseline|Vapocoolant (Pain Ease Medium Stream)|Applied Vapoccolant in a topical stream of 4 to 10 seconds duration to skin
735404|NCT01670487|P2|Participant Flow|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
735405|NCT01670487|P1|Participant Flow|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
735406|NCT01670487|O2|Outcome|Placebo (Nature's Tears)|Application of the stream steadily for 4 to 10 seconds
735407|NCT01670487|O1|Outcome|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
735408|NCT01670487|E2|Reported Event|Nature's Tears|"Apply sterile water (see manufacturer above) steadily 4-10 seconds onto the cannulation site.~Sterile water: Topical intervention of sterile water stream 4 to 10 seconds to skin."
735409|NCT01670487|E1|Reported Event|Vapocoolant (Pain Ease Medium Stream)|"Application of the stream steadily 4 to 10 seconds onto the cannulation site.~Vapocoolant: Topical stream of 4 to 10 seconds duration to skin"
735410|NCT01670279|B4|Baseline|Total|Total of all reporting groups
735434|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735411|NCT01670279|B3|Baseline|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735412|NCT01670279|B2|Baseline|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735413|NCT01670279|B1|Baseline|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735414|NCT01670279|P4|Participant Flow|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735415|NCT01670279|P3|Participant Flow|Brexpiprazole-Cohort 3|In the titration phase, participants were to receive 0.5 mg brexpiprazole or placebo QD for 7 days, followed by 1 mg brexpiprazole or placebo QD for 7 days, and then 2 mg brexpiprazole or placebo QD for 7 days. In the fixed dose phase, participants were to receive 3 mg brexpiprazole or placebo QD for 14 days. However, Cohort 3 was not conducted due to safety and tolerability results from Cohorts 1 and 2.
735416|NCT01670279|P2|Participant Flow|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735417|NCT01670279|P1|Participant Flow|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
737809|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
735418|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735419|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735420|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735421|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735422|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735423|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735424|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735425|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735426|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735427|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735428|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735429|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735430|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735431|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735432|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735433|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
813183|NCT01349829|O1|Outcome|HAVpur|
735435|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735436|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735437|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735438|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735439|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735440|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735441|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735442|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735443|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735444|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735445|NCT01670279|O3|Outcome|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735446|NCT01670279|O2|Outcome|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735447|NCT01670279|O1|Outcome|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735448|NCT01670279|E3|Reported Event|Placebo|In the titration phase, participants received 0.5 mg placebo QD for 7 days, followed by 1 mg placebo QD for 7 days. In the fixed dose phase, Cohort 1: participants received 2 mg placebo QD for 14 days, followed by 3 mg placebo QD for 14 days. Cohort 2: participants received 3 mg placebo QD for 14 days.
735449|NCT01670279|E2|Reported Event|Brexpiprazole-Cohort 2|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 3 mg brexpiprazole QD for 14 days.
735450|NCT01670279|E1|Reported Event|Brexpiprazole-Cohort 1|In the titration phase, participants received 0.5 mg brexpiprazole QD for 7 days, followed by 1 mg brexpiprazole QD for 7 days. In the fixed dose phase, participants received 2 mg brexpiprazole QD for 14 days, followed by 3 mg brexpiprazole QD for 14 days.
735451|NCT01670201|B1|Baseline|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
735452|NCT01670201|P1|Participant Flow|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
735453|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
735454|NCT01670201|O1|Outcome|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
735455|NCT01670201|E1|Reported Event|Mepilex Transfer Ag|"Mepilex Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.~Mepilex Transfer Ag: Silver dressing"
735456|NCT01670045|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735457|NCT01670045|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joint Count (DAS28) who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
736189|NCT01667796|E1|Reported Event|MS Subjects|MS patients
735458|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735459|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735460|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735461|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735480|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735462|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735463|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735464|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735465|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735466|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735467|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735468|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735469|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735470|NCT01670045|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA according to the ACR criteria and the DAS28 who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735471|NCT01670045|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA and the DAS28 joint scores who were on tocilizumab treatment within 8 weeks prior to start of study received tocilizumab in accordance with the licensed label recommendations, were observed for 6 months. The study was designed as non-interventional, no additional intervention in terms of follow-up visit, complementary examination or medication was required.
735472|NCT01670019|B3|Baseline|Total|Total of all reporting groups
735473|NCT01670019|B2|Baseline|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
736190|NCT01667731|B6|Baseline|Total|Total of all reporting groups
735474|NCT01670019|B1|Baseline|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735475|NCT01670019|P2|Participant Flow|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
735476|NCT01670019|P1|Participant Flow|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735477|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
735478|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735479|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
735513|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735481|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
735482|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735483|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
735484|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735485|NCT01670019|O2|Outcome|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
735486|NCT01670019|O1|Outcome|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735487|NCT01670019|E2|Reported Event|Placebo 1-4 Tablets Daily|"Matched, blinded placebo tablets will be administered at doses from 1-4 tablets daily depending on therapeutic response and tolerability~Placebo 1-4 tablets daily: One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID"
735488|NCT01670019|E1|Reported Event|Asenapine 5-20 mg Daily|"Asenapine will be started at 5 mg BID. The asenapine dose can be increased to 15 mg daily and then to 20 mg daily, or reduced to 5 mg daily, depending on therapeutic response and tolerability~Asenapine 5-20 mg daily: 5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID"
735489|NCT01668836|B5|Baseline|Total|Total of all reporting groups
735490|NCT01668836|B4|Baseline|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735491|NCT01668836|B3|Baseline|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735492|NCT01668836|B2|Baseline|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735493|NCT01668836|B1|Baseline|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735494|NCT01668836|P4|Participant Flow|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735495|NCT01668836|P3|Participant Flow|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735496|NCT01668836|P2|Participant Flow|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735497|NCT01668836|P1|Participant Flow|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735498|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735499|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735500|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735585|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735501|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735502|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735503|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735504|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735505|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735506|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735507|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735508|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735509|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735510|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735511|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735512|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735517|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735518|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735519|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735520|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735521|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735522|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735523|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735524|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735525|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735526|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735527|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1,000kcal per day for 30 days"
735528|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735529|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735530|NCT01668836|O4|Outcome|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
735531|NCT01668836|O3|Outcome|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
735532|NCT01668836|O2|Outcome|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
735533|NCT01668836|O1|Outcome|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
735534|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735535|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735536|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735537|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735538|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735539|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735540|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735541|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735542|NCT01668836|O4|Outcome|Women With Caloric Restriction|"12 women will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735543|NCT01668836|O3|Outcome|Men With Caloric Restriction|"12 men will follow a 1000kcal/day diet for 30 days~Caloric restriction: Diet of 1000kcal per day for 30 days"
735544|NCT01668836|O2|Outcome|Women With Resveratrol|"12 women will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735545|NCT01668836|O1|Outcome|Men With Resveratrol|"12 men will receive a pill with 500mg of resveratrol daily for 30 days~Resveratrol: 1 pill daily containing 500 mg/d of resveratrol for 30 days"
735546|NCT01668836|E4|Reported Event|Women With Caloric Restriction|12 women will follow a 1000Kcal/day of caloric restriction
735547|NCT01668836|E3|Reported Event|Men With Caloric Restriction|12 men will follow a 1000Kcal/day of caloric restriction
735548|NCT01668836|E2|Reported Event|Women With Resveratrol|12 women will receive a pill with 500mg of resveratrol
735549|NCT01668836|E1|Reported Event|Men With Resveratrol|12 men will receive a pill with 500mg of resveratrol
735550|NCT01668797|B3|Baseline|Total|Total of all reporting groups
735551|NCT01668797|B2|Baseline|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
735552|NCT01668797|B1|Baseline|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735553|NCT01668797|P4|Participant Flow|Phase C - Placebo (Double-Blind Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
735554|NCT01668797|P3|Participant Flow|Phase C - Brexpiprazole (Double-Blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735555|NCT01668797|P2|Participant Flow|Phase B (Stabilization Phase)|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
735600|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735556|NCT01668797|P1|Participant Flow|Phase A (Conversion Phase)|The purpose of the open-label conversion phase was 2-fold: 1) to cross-titrate the participants current antipsychotic treatment to brexpiprazole monotherapy over a period of 1 to 4 weeks and 2) to allow washout of prohibited medications in preparation for the stabilization phase.
735557|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735558|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735559|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735560|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735561|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735562|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735563|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735564|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735565|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735566|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735567|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735568|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735569|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735570|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735571|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735572|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735573|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735574|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735575|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735576|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735577|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735578|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735579|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735580|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735581|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735582|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735583|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735584|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
736557|NCT01665170|O1|Outcome|Placebo|Placebo arm
735586|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735587|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735588|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735589|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735590|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735591|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735592|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735593|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735594|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735595|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735596|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735597|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735598|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735599|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735602|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735603|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735604|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735605|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735606|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735607|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735608|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735609|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735610|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735611|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735612|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735613|NCT01668797|O2|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
735614|NCT01668797|O1|Outcome|Brexpiprazole|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735615|NCT01668797|E3|Reported Event|Placebo (Double-blnd Maintenance Phase)|Participants received placebo orally once daily for 52 weeks.
735616|NCT01668797|E2|Reported Event|Brexpiprazole (Double-blind Maintenance Phase)|Participants received maintenance treatment daily with brexpiprazole (at the final dose achieved during the stabilization phase) for up to 52 weeks.
735617|NCT01668797|E1|Reported Event|Single Blind Stabilization Phase|This single-blind stabilization phase was to titrate participants to a dose of brexpiprazole (1 to 4 mg/day) that would maintain stability of psychotic symptoms over 12 consecutive weeks (within a maximum of 36 weeks), while minimizing tolerability issues.
735618|NCT01668784|B3|Baseline|Total|Total of all reporting groups
735619|NCT01668784|B2|Baseline|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735620|NCT01668784|B1|Baseline|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735621|NCT01668784|P2|Participant Flow|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735622|NCT01668784|P1|Participant Flow|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735623|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735624|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735625|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735626|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735627|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735809|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
735628|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735629|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735630|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735631|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735632|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735633|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735634|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735635|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735636|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735637|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735638|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735639|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735640|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735641|NCT01668784|O2|Outcome|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735642|NCT01668784|O1|Outcome|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735643|NCT01668784|E2|Reported Event|Everolimus|Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735644|NCT01668784|E1|Reported Event|Nivolumab|Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
735645|NCT01669902|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735646|NCT01669902|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735647|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735648|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735649|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735650|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735651|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735652|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735653|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735654|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735655|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735656|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735657|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735658|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735659|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735660|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
813184|NCT01349829|O2|Outcome|Havrix|
735661|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735662|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735663|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735664|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735665|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735666|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735667|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735668|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735669|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735670|NCT01669902|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735671|NCT01669902|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were considered for or treated with tocilizumab monotherapy within the clinical routine were observed for a period of 6 months.
735673|NCT01669863|P1|Participant Flow|Use of ECMO in Non-intubated Patients|"ECMO used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
735674|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
735675|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|ECMO in non-intubated patients
735676|NCT01669863|O1|Outcome|Use of ECMO in Non-intubated Patients|"ECMO will be used in non-intubated patients with ARDS~ECMO~ECMO in non-intubated patients"
735677|NCT01669863|E1|Reported Event|Use of ECMO in Non-intubated Patients|Patients on ECMO
735678|NCT01669811|B3|Baseline|Total|Total of all reporting groups
735679|NCT01669811|B2|Baseline|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
735680|NCT01669811|B1|Baseline|D961H 20 mg BID|D961H 20 mg twice Daily
735681|NCT01669811|P2|Participant Flow|D961H 20 mg QD + Placebo|Hard capsule unidentifiable to D961H capsule 20 mg
735682|NCT01669811|P1|Participant Flow|D961H 20 mg BID|Hard capsule containing 22.3 mg of D961H as enteric coated pellets
735683|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
735684|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
735685|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
735686|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
735687|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
735688|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
735689|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
735690|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
735691|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
735692|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
735693|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
735694|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
735695|NCT01669811|O2|Outcome|D961H 20mg QD + Placebo|D961H 20mg once daily along with placebo
735696|NCT01669811|O1|Outcome|D961H 20mg Bid|D961H 20mg twice daily
735697|NCT01669811|E2|Reported Event|D961H 20 mg QD + Placebo|D961H 20 mg once daily along with placebo
735698|NCT01669811|E1|Reported Event|D961H 20 mg BID|D961H 20 mg twice Daily
735699|NCT01669785|B4|Baseline|Total|Total of all reporting groups
735700|NCT01669785|B3|Baseline|Group C|NUPRO Classic Prophy Paste.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride.Leave in contact for 60 seconds, rinse with water and expectorate.
735701|NCT01669785|B2|Baseline|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride.Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735702|NCT01669785|B1|Baseline|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin. Administered on day one only.Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735703|NCT01669785|P3|Participant Flow|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735704|NCT01669785|P2|Participant Flow|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735705|NCT01669785|P1|Participant Flow|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735706|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735707|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735708|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735709|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735710|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735711|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735712|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735713|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735714|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735828|NCT01668667|B2|Baseline|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
745851|NCT01627002|O9|Outcome|Part B Placebo|
735715|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735716|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735717|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735718|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735719|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735720|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735721|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735722|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735723|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735724|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735725|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735726|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735727|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735728|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735729|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735730|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735731|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735810|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
735732|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735733|NCT01669785|O3|Outcome|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735734|NCT01669785|O2|Outcome|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735735|NCT01669785|O1|Outcome|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735736|NCT01669785|E3|Reported Event|Group C|"NUPRO Classic Prophy Paste~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains no Novamin or Fluoride..~Leave in contact for 60 seconds, rinse with water and expectorate."
735737|NCT01669785|E2|Reported Event|Group B|"NUPRO Sensodyne Prophy Paste w/ Novamin w/ Fluoride~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 1.23% fluoride ion and 15% Novamin.~Leave in contact for 60 seconds, rinse with water and expectorate."
735738|NCT01669785|E1|Reported Event|Group A|"NUPRO Sensodyne Prophy Paste w/ Novamin~Administered on day one only. Unit dose cup contained enough paste for a single procedure. Contains 15% Novamin. Does not contain Fluoride.~Leave in contact for 60 seconds, rinse with water and expectorate."
735739|NCT01669720|B3|Baseline|Total|Total of all reporting groups
735740|NCT01669720|B2|Baseline|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
735741|NCT01669720|B1|Baseline|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
735742|NCT01669720|P2|Participant Flow|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
735743|NCT01669720|P1|Participant Flow|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
735744|NCT01669720|O2|Outcome|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
735745|NCT01669720|O1|Outcome|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
735746|NCT01669720|E2|Reported Event|Observation|Patients will be randomized 2:1 to receive Aflibercept. Patients who are randomized to observation will be followed per the study table, but will receive no intervention.
735747|NCT01669720|E1|Reported Event|Aflibercept|"Patients will be randomized 2:1, to receive Aflibercept,4mg/kg IV q2weeks until progression for a maximum of 2 years~Aflibercept: Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years"
735748|NCT01669629|B1|Baseline|All Subjects|All subjects who were enrolled in the study.
735749|NCT01669629|P2|Participant Flow|Etafilcon A \ Delefilcon A|"6-10 days of etafilcon A soft contact lens wear first then 6-10 days of delefilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
735750|NCT01669629|P1|Participant Flow|Delefilcon A \ Etafilcon A|"6-10 days of delefilcon A soft contact lens wear first then 6-10 days of etafilcon A soft contact lens wear~delefilcon A: Daily wear soft contact lens for bilateral distance vision correction use.~etafilcon A: Daily wear soft contact lens for bilateral distance vision correction use."
735751|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
735752|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
735753|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
735754|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
735755|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
735756|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
735757|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
735758|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
735759|NCT01669629|O2|Outcome|Etafilcon A|Subjects that received the etafilcon A lens in either the first or second period of the study.
735760|NCT01669629|O1|Outcome|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
735761|NCT01669629|E2|Reported Event|Etafilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
735762|NCT01669629|E1|Reported Event|Delefilcon A|Subjects that received the delefilcon A lens in either the first or second period of the study.
735763|NCT01669603|B3|Baseline|Total|Total of all reporting groups
735764|NCT01669603|B2|Baseline|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
735765|NCT01669603|B1|Baseline|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
735811|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
735766|NCT01669603|P2|Participant Flow|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
735767|NCT01669603|P1|Participant Flow|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
735768|NCT01669603|O2|Outcome|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
735769|NCT01669603|O1|Outcome|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
735770|NCT01669603|E2|Reported Event|Placebo|"Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.~Placebo: Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product."
735771|NCT01669603|E1|Reported Event|Bifidobacterium Animalis Lactis Bl-04|"Bifidobacterium animalis subspecies lactis Bl-04 as powder mixed into drink.~Bifidobacterium lactis Bl-04: The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier."
735772|NCT01669577|B1|Baseline|Severe Trauma Patients|Hypotensive Patients (SBP<90mmHg), severe TBI, high energy traumas All patients must have calculated ISS >15 to be included and a written informed consent should be available
735773|NCT01669577|P1|Participant Flow|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR collection of vital signs, blood chemistry; severity scores and intensive care unit(ICU) LOS(length of stay) were recorded"
735774|NCT01669577|O1|Outcome|Severe Trauma Patients|"intervention : analysis of blood samples; vital signs and clinical outcomes recorded~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
735775|NCT01669577|E1|Reported Event|Severe Trauma Patients|"intervention : analysis of blood samples~analysis of blood samples (0,2 ml): analysis of blood samples (0,2 ml)~analysis of blood samples: analysis of blood samples regarding electrolytes, blood gases, glucose, PT/INR"
735776|NCT01669174|B3|Baseline|Total|Total of all reporting groups
735777|NCT01669174|B2|Baseline|Placebo|Placebo to BYM338 30mg/kg
735778|NCT01669174|B1|Baseline|BYM338|30 mg/kg
735779|NCT01669174|P2|Participant Flow|Placebo|Placebo to BYM338 30mg/kg
735780|NCT01669174|P1|Participant Flow|BYM338|30 mg/kg
735781|NCT01669174|O1|Outcome|BYM338|30 mg/kg
735782|NCT01669174|O1|Outcome|BYM338|30 mg/kg
735783|NCT01669174|O1|Outcome|BYM338|30 mg/kg
735784|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
735785|NCT01669174|O1|Outcome|BYM338|30 mg/kg
735786|NCT01669174|O2|Outcome|Placebo|Placebo to BYM338 30mg/kg
735787|NCT01669174|O1|Outcome|BYM338|30 mg/kg
735788|NCT01669174|E2|Reported Event|Placebo|Placebo to BYM338 30mg/kg
735789|NCT01669174|E1|Reported Event|BYM338 30mg/kg|BYM338 30mg/kg
735790|NCT01669148|B1|Baseline|All Study Participants|All study participants in both arms. 496 enrolled and 426 completed study, but no information available to distinguish study arms.
735791|NCT01669148|P1|Participant Flow|All Study Participants|All participants enrolled in study
735792|NCT01669148|O2|Outcome|Tomosynthesis Alone First Then Conventional+Tomo 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).~Conventional: conventional (2D) imaging (standard mammography)"
735793|NCT01669148|O1|Outcome|Conventional + Tomosynthesis First Then Tomo Alone 1 mo. Later|"Tomosynthesis: The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).~Conventional: conventional (2D) imaging (standard mammography)"
735794|NCT01669148|E1|Reported Event|All Study Participants|All participants enrolled in the study
735795|NCT01669122|B1|Baseline|Safety Population|Baseline measurements were performed for safety population which included all participants in the study who were dispensed at least one of the study treatment. Out of 40 randomized participants, one participant did not receive any treatment and was lost to follow-up.
735796|NCT01669122|P1|Participant Flow|Total Participants|
735797|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
735798|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
735799|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
735800|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
735801|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
735802|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
735803|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
735804|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
735805|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
735806|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
735807|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
735808|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
736558|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
735813|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
735814|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
735815|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
735816|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A was administered orally as a single dose treatment.
735817|NCT01669122|O4|Outcome|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
735818|NCT01669122|O3|Outcome|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
735819|NCT01669122|O2|Outcome|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
735820|NCT01669122|O1|Outcome|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
735821|NCT01669122|E4|Reported Event|Reference Lozenge|Reference 4 mg nicotine lozenge, was administered orally as a single dose treatment.
735822|NCT01669122|E3|Reported Event|Test Lozenge (C)|4 mg nicotine lozenge with excipient C, was administered orally as a single dose treatment.
735823|NCT01669122|E2|Reported Event|Test Lozenge (B)|4 mg nicotine lozenge with excipient B, was administered orally as a single dose treatment.
735824|NCT01669122|E1|Reported Event|Test Lozenge (A)|4 mg nicotine lozenge with excipient A, was administered orally as a single dose treatment.
735825|NCT01668667|B5|Baseline|Total|Total of all reporting groups
735826|NCT01668667|B4|Baseline|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
735827|NCT01668667|B3|Baseline|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
735829|NCT01668667|B1|Baseline|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
735830|NCT01668667|P4|Participant Flow|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
735831|NCT01668667|P3|Participant Flow|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
735832|NCT01668667|P2|Participant Flow|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
735833|NCT01668667|P1|Participant Flow|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
735834|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
735835|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
735836|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
735837|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
735838|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
735839|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
735840|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
735841|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
735842|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
735843|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
735844|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
735845|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
735846|NCT01668667|O4|Outcome|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PM
735847|NCT01668667|O3|Outcome|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
735848|NCT01668667|O2|Outcome|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
735849|NCT01668667|O1|Outcome|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
735850|NCT01668667|E4|Reported Event|GSK1838262 Placebo Match|Once-daily dose with food in the evening at approximately 5 PMmatching placebo.
735851|NCT01668667|E3|Reported Event|GSK1838262 300 mg|Once-daily dose with food in the evening at approximately 5 PM
735852|NCT01668667|E2|Reported Event|GSK1838262 450 mg|Once-daily dose with food in the evening at approximately 5 PM
735853|NCT01668667|E1|Reported Event|GSK1838262 600 mg|Once-daily dose with food in the evening at approximately 5 PM
735854|NCT01668654|B1|Baseline|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735855|NCT01668654|P1|Participant Flow|Retigabine/Ezogabine TID|Participants (par.) received retigabine/ezogabine as immediate release (IR) tablets three times a day (TID) as add-on therapy. Six dose strengths (25 milligrams(mg)/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg per day (mg/day) (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735910|NCT01668628|E1|Reported Event|Incident PD Patients|First treatment for ESRD by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is CAPD or APD and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
735911|NCT01668589|B5|Baseline|Total|Total of all reporting groups
736559|NCT01665170|O1|Outcome|Placebo|Placebo arm
735856|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735857|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735858|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735859|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735921|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735860|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735861|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735862|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735863|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735864|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735865|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735866|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
736112|NCT01667900|B2|Baseline|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
813185|NCT01349829|O1|Outcome|HAVpur|
735867|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735868|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735869|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735870|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735922|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
736154|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
735871|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735872|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735873|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735874|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735875|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735876|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735877|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
813186|NCT01349829|O2|Outcome|Havrix|
735878|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735879|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735880|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735881|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735923|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
736155|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
735882|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735883|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735884|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735885|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735886|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735887|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735888|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
813187|NCT01349829|O1|Outcome|HAVpur|
735889|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735890|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735891|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735892|NCT01668654|O1|Outcome|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability). Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735924|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
736156|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
735893|NCT01668654|E1|Reported Event|Retigabine/Ezogabine TID|Par. received retigabine/ezogabine as IR tablets TID as add-on therapy. Six dose strengths (25 mg/50 mg/100 mg/200 mg/300 mg/400 mg) were used. Doses may have been titrated no more frequently than once per week. Par. dose was adjusted as needed (e.g. based on: weight change due to increasing age and growth, efficacy or tolerability) over the course of this long-term open-label extension study. Physicians used their clinical judgment in making dose adjustments. Maximum doses allowed in the study were 900 mg/day (>50 kilogram (kg) weight) or 450 mg/day (30 to 50 kg weight) for par. aged <16 years old and the maximum doses allowed were 1200 mg/day (>50 kg weight) or 600 mg/day (30 to 50 kg weight) for par. aged >=16 years old.
735894|NCT01668628|B4|Baseline|Total|Total of all reporting groups
735895|NCT01668628|B3|Baseline|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
735896|NCT01668628|B2|Baseline|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
735897|NCT01668628|B1|Baseline|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dia;ysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
735898|NCT01668628|P3|Participant Flow|Prevalent Hemodialysis (HD) Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
735899|NCT01668628|P2|Participant Flow|Prevalent Peritoneal Dialysis (PD) Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
735900|NCT01668628|P1|Participant Flow|Incident Peritoneal Dialysis(PD) Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
735901|NCT01668628|O2|Outcome|Overhydration Group|Hemodialysis patients with baseline OH value >+2L
735902|NCT01668628|O1|Outcome|Normohydration Group|Hemodialysis patients with baseline -2L<OH value <+2L
735903|NCT01668628|O2|Outcome|Overhydration Group|Peritoneal dialysis patients with baseline OH value >+2L
735904|NCT01668628|O1|Outcome|Normohydration Group|Peritoneal dialysis patients with baseline -2L<OH value <+2L
735905|NCT01668628|O3|Outcome|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
735906|NCT01668628|O2|Outcome|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
735907|NCT01668628|O1|Outcome|Incident PD Patients|First treatment for end stage of renal disease (ESRD) by any peritoneal dialysis modality within 30 days prior to or following enrollment (patients may be enrolled prior to commencing first treatment if there is clear indication that the treatment modality is continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) and they consent in advance to enter the study) and patients who don't have any experience of dialysis treatment before this study
735908|NCT01668628|E3|Reported Event|Prevalent HD Patients|Prevalent hemodialysis(HD) patients who are under hemodialysis treatment more than 6 months
735909|NCT01668628|E2|Reported Event|Prevalent PD Patients|Prevalent peritoneal dialysis(PD) patients who are under peritoneal dialysis treatment more than 6 months
736179|NCT01667848|E2|Reported Event|Group B|Insufflation with warm gas during laparoscopic cholecystectomy
813188|NCT01349829|O2|Outcome|Havrix|
735912|NCT01668589|B4|Baseline|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735913|NCT01668589|B3|Baseline|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735914|NCT01668589|B2|Baseline|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735915|NCT01668589|B1|Baseline|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735916|NCT01668589|P4|Participant Flow|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735917|NCT01668589|P3|Participant Flow|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735918|NCT01668589|P2|Participant Flow|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735919|NCT01668589|P1|Participant Flow|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735920|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735955|NCT01668589|E1|Reported Event|Germany|Prolia 60 mg SC Q6M
736350|NCT01667224|O2|Outcome|Placebo (450mg/Day) for 12 Week|Placebo: Amount and calorie of placebo are same with Actiponin
735925|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735926|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735927|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735928|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735929|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735930|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735931|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735932|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735933|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735934|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735935|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735936|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735937|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735938|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735939|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735940|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735941|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735942|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735943|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735944|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735945|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735946|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735947|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735948|NCT01668589|O4|Outcome|Belgium|Participants in Belgium who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735949|NCT01668589|O3|Outcome|Greece|Participants in Greece who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735950|NCT01668589|O2|Outcome|Austria|Participants in Austria who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735951|NCT01668589|O1|Outcome|Germany|Participants in Germany who received denosumab 60 mg once every 6 months subcutaneously according to the approved prescribing information for the treatment of postmenopausal osteoporosis (PMO) in routine clinical practice.
735952|NCT01668589|E4|Reported Event|Belgium|Prolia 60 mg SC Q6M
735953|NCT01668589|E3|Reported Event|Greece|Prolia 60 mg SC Q6M
735954|NCT01668589|E2|Reported Event|Austria|Prolia 60 mg SC Q6M
735956|NCT01668173|B1|Baseline|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
735957|NCT01668173|P1|Participant Flow|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
735958|NCT01668173|O1|Outcome|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
735959|NCT01668173|E1|Reported Event|All Patients|HSP90 Inhibitor, AUY922, in Patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera Myelofibrosis (Post-PV MF), Post-Essential Thrombocythemia Myelofibrosis (Post-ET MF), and Refractory PV/ET
735960|NCT01668017|B6|Baseline|Total|Total of all reporting groups
735961|NCT01668017|B5|Baseline|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735962|NCT01668017|B4|Baseline|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735963|NCT01668017|B3|Baseline|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735964|NCT01668017|B2|Baseline|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735965|NCT01668017|B1|Baseline|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21- day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735966|NCT01668017|P5|Participant Flow|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735967|NCT01668017|P4|Participant Flow|Part 1: Pimasertib 30 mg in Hepatocellular Carcinoma (HCC)|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735968|NCT01668017|P3|Participant Flow|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735969|NCT01668017|P2|Participant Flow|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735970|NCT01668017|P1|Participant Flow|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735971|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735972|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736560|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
735973|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735974|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735975|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735976|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735977|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735978|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735979|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735980|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg twice a day (BID) until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735981|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736150|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
735982|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735983|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735984|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735985|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735986|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735987|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735988|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735989|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735990|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735991|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735992|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735993|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735994|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735995|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735996|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735997|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736561|NCT01665170|O1|Outcome|Placebo|Placebo arm
735998|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
735999|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736000|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736001|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736002|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736003|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736004|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736005|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736006|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736151|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736007|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736008|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736009|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736010|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736011|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736012|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736013|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with HCC were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736014|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736015|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736016|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736017|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736018|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736019|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736020|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736021|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736022|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736562|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736023|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736024|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736025|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736026|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736027|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736028|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736029|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736030|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 milligram (mg) twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736031|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736152|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736032|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736033|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736034|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736035|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736036|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736037|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736038|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736039|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736040|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736041|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736042|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736043|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736044|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736045|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736046|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736047|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736048|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736049|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736050|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736051|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736052|NCT01668017|O4|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736053|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736054|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736055|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736056|NCT01668017|O1|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736153|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736057|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736058|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736059|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736060|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736061|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736062|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736063|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736064|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736065|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736066|NCT01668017|O5|Outcome|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
736067|NCT01668017|O4|Outcome|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
736068|NCT01668017|O3|Outcome|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject, whichever comes first.
736069|NCT01668017|O2|Outcome|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736070|NCT01668017|O1|Outcome|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736071|NCT01668017|E5|Reported Event|Part 1: Pimasertib 45 mg in HCC|Subjects with HCC were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736180|NCT01667848|E1|Reported Event|Group A|Insufflation with cold gas during laparoscopic cholecystectomy
736181|NCT01667796|B3|Baseline|Total|Total of all reporting groups
736072|NCT01668017|E4|Reported Event|Part 1: Pimasertib 30 mg in HCC|Subjects with HCC were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736073|NCT01668017|E3|Reported Event|Part 1: Pimasertib 60 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736074|NCT01668017|E2|Reported Event|Part 1: Pimasertib 45 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736075|NCT01668017|E1|Reported Event|Part 1: Pimasertib 30 mg in Solid Tumor|Subjects with solid tumor were administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
736076|NCT01668004|B1|Baseline|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
736077|NCT01668004|P1|Participant Flow|GLM 50 mg|Golimumab (GLM) given subcutaneously at a dose of 50 mg once monthly for up to 12 months
736078|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
736079|NCT01668004|O1|Outcome|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
736080|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
736081|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
736082|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
736083|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
736084|NCT01668004|O2|Outcome|After GLM Treatment Start|GLM observation period: Prospective follow-up of participants given GLM subcutaneously at a dose of 50 mg once monthly for up to 12 months
745852|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
736085|NCT01668004|O1|Outcome|Before Initial Anti-TNF/GLM Treatment|Historical observation period: Retrospective record review over the 12 months prior to the initial anti-TNF treatment (anti-TNF experienced participants) or the first GLM dose (anti-TNF naïve participants).
736086|NCT01668004|E1|Reported Event|GLM 50 mg|GLM given subcutaneously at a dose of 50 mg once monthly for up to 12 months
736087|NCT01667978|B3|Baseline|Total|Total of all reporting groups
736088|NCT01667978|B2|Baseline|Control|"o PI therapy, control group~Norethindrone acetate"
736089|NCT01667978|B1|Baseline|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
736090|NCT01667978|P2|Participant Flow|Control|"no PI therapy, control group~Norethindrone acetate~17 controls (4 no ARV)"
736091|NCT01667978|P1|Participant Flow|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate~16 HIV positive on PI (atazanavir ritonavir 10, darunovir, lopinavir)"
736092|NCT01667978|O2|Outcome|Control|"o PI therapy, control group~Norethindrone acetate"
736093|NCT01667978|O1|Outcome|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
736094|NCT01667978|E2|Reported Event|Control|"o PI therapy, control group~Norethindrone acetate"
736095|NCT01667978|E1|Reported Event|Protease Inhibitor|"Study group with PI: atazanavir ritonavir~Norethindrone acetate"
736096|NCT01667926|B3|Baseline|Total|Total of all reporting groups
736097|NCT01667926|B2|Baseline|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
736098|NCT01667926|B1|Baseline|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
736099|NCT01667926|P3|Participant Flow|Screen Fail/No Baseline|"Participants who signed informed consent and were screened but did not meet study inclusion/exclusion criteria.~Participants in the screen fail group were not randomized to either Ketamine nor placebo and did not receive any infusions."
736100|NCT01667926|P2|Participant Flow|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
736101|NCT01667926|P1|Participant Flow|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
736102|NCT01667926|O2|Outcome|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
736103|NCT01667926|O1|Outcome|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
736104|NCT01667926|O2|Outcome|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
736105|NCT01667926|O1|Outcome|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
736106|NCT01667926|E2|Reported Event|Placebo|"Subjects will receive 6 infusions of normal saline over 3 weeks.~Placebo"
736107|NCT01667926|E1|Reported Event|Ketamine|"Subject will receive 6 infusions of ketamine over three weeks.~Ketamine: ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen."
736108|NCT01667900|B6|Baseline|Total|Total of all reporting groups
736109|NCT01667900|B5|Baseline|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736110|NCT01667900|B4|Baseline|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736111|NCT01667900|B3|Baseline|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736113|NCT01667900|B1|Baseline|Part A-Healthy|Part A (single-dose, 3 treatment period, crossover design) involved overtly healthy participants only. Each participant received single doses of placebo and 2 of the 3 dulaglutide doses (0.5, 0.75, and 1.5 mg), in 3 treatment periods, such that placebo was administered SQ to all 16 participants and 0.5, 0.75, and 1.5 mg dulaglutide was administered SQ to 10, 11, and 11 participants, respectively. There was a washout period of at least 28 days between doses.
736114|NCT01667900|P20|Participant Flow|Placebo (Part B-T2DM)|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736115|NCT01667900|P19|Participant Flow|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736116|NCT01667900|P18|Participant Flow|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736117|NCT01667900|P17|Participant Flow|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks in Part B
736118|NCT01667900|P16|Participant Flow|First Placebo, Then 1.5 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
736119|NCT01667900|P15|Participant Flow|First 1.5 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
736120|NCT01667900|P14|Participant Flow|First Placebo, Then 1.5 mg, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
736121|NCT01667900|P13|Participant Flow|First 0.75 mg, Then Placebo, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
737810|NCT01660321|E1|Reported Event|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
736122|NCT01667900|P12|Participant Flow|First 0.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
736123|NCT01667900|P11|Participant Flow|First 1.5 mg, Then 0.75 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
736124|NCT01667900|P10|Participant Flow|First 0.5 mg, Then 0.75 mg, Then Placebo (Part A-Helathy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
736125|NCT01667900|P9|Participant Flow|First Placebo, Then 0.75 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
736126|NCT01667900|P8|Participant Flow|First Placebo, Then 0.75 mg, Then 0.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.75 mg dulaglutide administered once SQ~Period 3: 0.5 mg dulaglutide administered once SQ"
736127|NCT01667900|P7|Participant Flow|First 0.75 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
736128|NCT01667900|P6|Participant Flow|First Placebo, Then 0.5 mg, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: placebo administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
736129|NCT01667900|P5|Participant Flow|First 1.5 mg, Then Placebo, Then 0.75 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 1.5 mg dulaglutide administered once SQ~Period 2: placebo administered once SQ~Period 3: 0.75 mg dulaglutide administered once SQ"
736130|NCT01667900|P4|Participant Flow|First 0.5 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
736131|NCT01667900|P3|Participant Flow|First 0.75 mg, Then 1.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 1.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
736132|NCT01667900|P2|Participant Flow|First 0.75 mg, Then 0.5 mg, Then Placebo (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.75 mg dulaglutide administered once SQ~Period 2: 0.5 mg dulaglutide administered once SQ~Period 3: placebo administered once SQ"
736182|NCT01667796|B2|Baseline|Healthy Controls|Female subjects without MS
736183|NCT01667796|B1|Baseline|MS Subjects|Female subjects with MS
736184|NCT01667796|P2|Participant Flow|Healthy Controls|Healthy control subjects
736185|NCT01667796|P1|Participant Flow|MS Subjects|MS patients
736133|NCT01667900|P1|Participant Flow|First 0.5 mg, Then Placebo, Then 1.5 mg (Part A-Healthy)|"Part A involved overtly healthy participants and was comprised of 3 treatment periods. There was a washout period of at least 28 days between doses.~Period 1: 0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ)~Period 2: placebo administered once SQ~Period 3: 1.5 mg dulaglutide administered once SQ"
736134|NCT01667900|O4|Outcome|Placebo (Part B-T2DM|Placebo administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736135|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736136|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736137|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736138|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736139|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736140|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736141|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736142|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736143|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736144|NCT01667900|O6|Outcome|1.5 mg Dulaglutide (Part B-T2DM)|1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736145|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736146|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736147|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736148|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736149|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736157|NCT01667900|O5|Outcome|0.75 mg Dulaglutide (Part B-T2DM)|0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736158|NCT01667900|O4|Outcome|0.5 mg Dulaglutide (Part B-T2DM)|0.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks in Part B
736159|NCT01667900|O3|Outcome|1.5 mg Dulaglutide (Part A-Healthy)|1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736160|NCT01667900|O2|Outcome|0.75 mg Dulaglutide (Part A-Healthy)|0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736161|NCT01667900|O1|Outcome|0.5 mg Dulaglutide (Part A-Healthy)|0.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods in Part A
736162|NCT01667900|E8|Reported Event|1.5 mg Dulaglutide (Part B-T2DM)|"1.5 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736163|NCT01667900|E7|Reported Event|0.75 mg Dulaglutide (Part B-T2DM)|"0.75 mg dulaglutide administered to participants with T2DM once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736164|NCT01667900|E6|Reported Event|0.5 mg Dulaglutide (Part B-T2DM)|"0.5 mg dulaglutide administered to participants with Type 2 diabetes mellitus (T2DM) once weekly SQ for 4 weeks~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736165|NCT01667900|E5|Reported Event|Placebo (Part B-T2DM)|"Placebo administered to participants with T2DM once weekly SQ for 4 weeks~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736166|NCT01667900|E4|Reported Event|1.5 mg Dulaglutide (Part A-Healthy)|"1.5 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736167|NCT01667900|E3|Reported Event|0.75 mg Dulaglutide (Part A-Healthy)|"0.75 mg dulaglutide administered once SQ to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736168|NCT01667900|E2|Reported Event|0.5 mg Dulaglutide (Part A-Healthy)|"0.5 milligrams (mg) dulaglutide administered once subcutaneously (SQ) to healthy participants in 1 of 3 treatment periods~Dulaglutide~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736169|NCT01667900|E1|Reported Event|Placebo (Part A-Healthy)|"Placebo administered once SQ to healthy participants in 1 of 3 treatment periods~Placebo: Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms."
736170|NCT01667848|B3|Baseline|Total|Total of all reporting groups
736171|NCT01667848|B2|Baseline|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
736172|NCT01667848|B1|Baseline|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
736173|NCT01667848|P2|Participant Flow|Group B: Insufflation With Warm Gas|Insufflation with warm gas during laparoscopic cholecystectomy
736174|NCT01667848|P1|Participant Flow|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
736175|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
736176|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
736177|NCT01667848|O2|Outcome|Group B|Insufflation with warm gas during laparoskopic cholecystectomy
736178|NCT01667848|O1|Outcome|Group A: Insufflation With Cold Gas|Insufflation with cold gas during laparoskopic cholecystectomy
736191|NCT01667731|B5|Baseline|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736192|NCT01667731|B4|Baseline|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736193|NCT01667731|B3|Baseline|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736194|NCT01667731|B2|Baseline|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736195|NCT01667731|B1|Baseline|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736196|NCT01667731|P5|Participant Flow|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736197|NCT01667731|P4|Participant Flow|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736198|NCT01667731|P3|Participant Flow|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced (TE), genotype 2)
736199|NCT01667731|P2|Participant Flow|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736200|NCT01667731|P1|Participant Flow|SOF+RBV 12 Wk GT 2 TN|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive (TN), genotype (GT) 2)
737811|NCT01660230|B13|Baseline|Total|Total of all reporting groups
736201|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736202|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736203|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736204|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736205|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736206|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736207|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736208|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736209|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736210|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736211|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736212|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736213|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736214|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736215|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736216|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736217|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736218|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736219|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736220|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736221|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736222|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736223|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736224|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736225|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736226|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736227|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736228|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736563|NCT01665170|O1|Outcome|Placebo|Placebo arm
736229|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736230|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736231|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736232|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736233|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736234|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736235|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736236|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736237|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736238|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736239|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736240|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736241|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736242|NCT01667731|O2|Outcome|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
736243|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
736244|NCT01667731|O5|Outcome|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736245|NCT01667731|O4|Outcome|SOF+RBV 24 Wk GT 3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 3)
736246|NCT01667731|O3|Outcome|SOF+RBV 24 Wk GT 2 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotype 2)
736247|NCT01667731|O2|Outcome|SOF+RBV 12 Wk GT 3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 3)
736248|NCT01667731|O1|Outcome|SOF+RBV 12 Wk GT 2 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotype 2)
736249|NCT01667731|E3|Reported Event|SOF+RBV 24 Wk GT 1 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment naive, genotype 1)
736250|NCT01667731|E2|Reported Event|SOF+RBV 24 Wk GT 2/3 TE|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 24 weeks (treatment experienced, genotypes 2 and 3)
736251|NCT01667731|E1|Reported Event|SOF+RBV 12 Wk GT 2/3 TN|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for 12 weeks (treatment naive, genotypes 2 and 3)
736252|NCT01667679|B3|Baseline|Total|Total of all reporting groups
736253|NCT01667679|B2|Baseline|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally.
736254|NCT01667679|B1|Baseline|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1, participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril.
736255|NCT01667679|P2|Participant Flow|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736256|NCT01667679|P1|Participant Flow|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period (TP) 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736293|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736564|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736257|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736258|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736259|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736260|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736261|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736262|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736263|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736264|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736265|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736294|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736295|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736296|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736266|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736267|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736268|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736307|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736308|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736309|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736269|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736270|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736271|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736272|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736273|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736274|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736275|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736276|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736277|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736310|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736311|NCT01667679|E2|Reported Event|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736312|NCT01667679|E1|Reported Event|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736278|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736279|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736280|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736281|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736282|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736283|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736284|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736285|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736286|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736313|NCT01667536|B1|Baseline|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
736314|NCT01667536|P1|Participant Flow|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
736404|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736287|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736288|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736289|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736290|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736291|NCT01667679|O2|Outcome|100 mg Sumatriptan+PBO (TP1)/20 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo tablet taken orally. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736292|NCT01667679|O1|Outcome|20 mg Sumatriptan+PBO (TP1)/100 mg Sumatriptan+PBO (TP2)|In Treatment Period 1 (<=12 weeks), participants received 20 milligrams (mg) sumatriptan nasal powder delivered intranasally with a bi-directional device and a placebo (PBO) tablet taken orally. After completing Treatment Period 1 (upon reaching 12 weeks or treating the fifth qualifying migraine headache in the treatment period, whichever came first), participants entered Treatment Period 2 (<=12 weeks), during which they received a 100 mg sumatriptan tablet taken orally and placebo (lactose) as a nasal powder administered into the nostril on the side of the migraine, followed by another administration into the other nostril. Participants were to treat <=5 qualifying migraine headaches during Treatment Period 2.
736297|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736298|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736299|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736300|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736301|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736302|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736303|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736304|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736305|NCT01667679|O2|Outcome|100 mg Sumatriptan Tablet|Participants received a 100 mg sumatriptan tablet taken orally in Treatment Period 1 or Treatment Period 2.
736306|NCT01667679|O1|Outcome|20 mg Sumatriptan Nasal Powder|Participants received 20 mg sumatriptan nasal powder delivered intranasally with a bi-directional device in Treatment Period 1 or Treatment Period 2.
736315|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
736316|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
736317|NCT01667536|O2|Outcome|Drug: 99mTc-MIP-1404 + MRI|Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on MRI imaging.
736318|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404. Sensitivity based on 99mTc-MIP-1404 imaging."
736319|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
736320|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404 Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
736321|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
736322|NCT01667536|O1|Outcome|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
736323|NCT01667536|E1|Reported Event|Drug: 99mTc-MIP-1404|"20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404~Drug: 99mTc-MIP-1404: A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404"
736324|NCT01667471|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736325|NCT01667471|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg intravenously (IV) every 4 weeks up to 104 weeks or until tocilizumab was commercially available for polyarticular-course Juvenile Idiopathic Arthritis (pcJIA).
736326|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736327|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736328|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736329|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736330|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736331|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736332|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736333|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736334|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736335|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736336|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736337|NCT01667471|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736338|NCT01667471|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736339|NCT01667471|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV every 4 weeks up to 104 weeks or until tocilizumab was commercially available for pcJIA.
736387|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736340|NCT01667432|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
736341|NCT01667432|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
736342|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
736343|NCT01667432|O1|Outcome|Peginterferon Alfa-2a|Intent-to-treat population: All participants who received at least 1 dose of peginterferon alfa-2a.
736344|NCT01667432|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (PEGASYS®) 180 µg subcutaneously in the abdomen or thigh once weekly for 12 weeks.
736345|NCT01667224|B3|Baseline|Total|Total of all reporting groups
736346|NCT01667224|B2|Baseline|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
736347|NCT01667224|B1|Baseline|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
736348|NCT01667224|P2|Participant Flow|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
736349|NCT01667224|P1|Participant Flow|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
745853|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
736351|NCT01667224|O1|Outcome|Actiponin(450mg/Day) for 12week|Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.
736352|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
736353|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
736354|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
736355|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
736356|NCT01667224|O2|Outcome|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
736357|NCT01667224|O1|Outcome|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
736358|NCT01667224|E2|Reported Event|Placebo|"Placebo(450mg/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Actiponin."
736359|NCT01667224|E1|Reported Event|Actiponin|"Actiponin(extract of Gynostema pentaphyllum, 450mg/day) for 12weeks~Actiponin : The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material."
736360|NCT01667107|B3|Baseline|Total|Total of all reporting groups
736361|NCT01667107|B2|Baseline|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736362|NCT01667107|B1|Baseline|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736363|NCT01667107|P2|Participant Flow|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736364|NCT01667107|P1|Participant Flow|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736365|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736388|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736389|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736366|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736367|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736368|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736369|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736370|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736592|NCT01665157|B2|Baseline|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount of 2L PEG-ELS
736371|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736372|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736373|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736374|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736375|NCT01667107|O2|Outcome|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736376|NCT01667107|O1|Outcome|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736377|NCT01667107|E2|Reported Event|Non-Cystic Fibrosis Participants|Non-cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736378|NCT01667107|E1|Reported Event|Cystic Fibrosis Participants|Cystic fibrosis participants received posaconazole 400 mg oral solution twice daily administered with Calogen® to optimize absorption for a total of 6 weeks starting within 12 hours of leaving surgery, thereafter administered in the hospital or as an outpatient; the dose could be changed to posaconazole 200 mg 4 times per day if the participant is unable to meet the conditions for optimal absorption of posaconazole.
736379|NCT01666951|B3|Baseline|Total|Total of all reporting groups
736380|NCT01666951|B2|Baseline|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736381|NCT01666951|B1|Baseline|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736382|NCT01666951|P2|Participant Flow|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736383|NCT01666951|P1|Participant Flow|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736384|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736385|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736386|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736565|NCT01665170|O1|Outcome|Placebo|Placebo arm
736390|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736391|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736392|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736393|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736394|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736395|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736396|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736397|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736398|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736399|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736400|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736401|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736402|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736403|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736405|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736406|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736407|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736408|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736409|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736410|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736411|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736412|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736413|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736414|NCT01666951|O2|Outcome|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736415|NCT01666951|O1|Outcome|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736416|NCT01666951|E2|Reported Event|Prograf|"Prograf Capsules, twice daily (Astellas Pharma US, Deerfield, IL)~Prograf: Tacrolimus"
736417|NCT01666951|E1|Reported Event|LCP-Tacro|"LCP-Tacro Tablets, once daily (Veloxis Pharmaceuticals A/S, Horsholm, DK)~LCP-Tacro tablets: Tacrolimus"
736418|NCT01666912|B3|Baseline|Total|Total of all reporting groups
736419|NCT01666912|B2|Baseline|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
736420|NCT01666912|B1|Baseline|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
736421|NCT01666912|P2|Participant Flow|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
736422|NCT01666912|P1|Participant Flow|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
736423|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
736424|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
736425|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
736426|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
736427|NCT01666912|O2|Outcome|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
736428|NCT01666912|O1|Outcome|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
736429|NCT01666912|E2|Reported Event|Immediate Postpartum Contraceptive Implant|"randomized to receive contraceptive implant prior to leaving the hospital postpartum~Contraceptive implant"
736430|NCT01666912|E1|Reported Event|6 Week Postpartum Contraceptive Implant|"randomized to receive contraceptive implant at normal 6 week postpartum visit~Contraceptive implant"
736431|NCT01666782|B3|Baseline|Total|Total of all reporting groups
736432|NCT01666782|B2|Baseline|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736433|NCT01666782|B1|Baseline|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736459|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
736566|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736434|NCT01666782|P2|Participant Flow|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736435|NCT01666782|P1|Participant Flow|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736436|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736437|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736438|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736439|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736440|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736441|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736442|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736443|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736444|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736445|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736446|NCT01666782|O2|Outcome|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736447|NCT01666782|O1|Outcome|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736448|NCT01666782|E2|Reported Event|Standard Trivalent Influenza Vaccine|Standard Trivalent Influenza Vaccine: Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
736449|NCT01666782|E1|Reported Event|High-Dose Influenza Vaccine|High-Dose Influenza Vaccine: Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
736450|NCT01666210|B3|Baseline|Total|Total of all reporting groups
736451|NCT01666210|B2|Baseline|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
736452|NCT01666210|B1|Baseline|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
736453|NCT01666210|P2|Participant Flow|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
736454|NCT01666210|P1|Participant Flow|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
736455|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
736456|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
736457|NCT01666210|O2|Outcome|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
736458|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
736567|NCT01665170|O1|Outcome|Placebo|Placebo arm
736568|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736460|NCT01666210|O1|Outcome|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
736461|NCT01666210|E2|Reported Event|Placebo Vehicle Punctum Plug|"Placebo punctum plug insertion~Placebo Vehicle Punctum Plug: Hydrogel punctum plug without dexamethasone"
736462|NCT01666210|E1|Reported Event|Dexamethasone Punctum Plug|"Sustained and tapered release of dexamethasone from hydrogel punctum plug following insertion over 30 days~OTX-DP (Dexamethasone punctum plug): Sustained and tapered release of dexamethasone from hydrogel punctum plug"
736463|NCT01666197|B3|Baseline|Total|Total of all reporting groups
736464|NCT01666197|B2|Baseline|Placebo|placebo: placebo
736465|NCT01666197|B1|Baseline|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
736466|NCT01666197|P2|Participant Flow|Placebo|placebo: placebo
736467|NCT01666197|P1|Participant Flow|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
736468|NCT01666197|O2|Outcome|Placebo|placebo: placebo
736469|NCT01666197|O1|Outcome|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
736470|NCT01666197|E2|Reported Event|Placebo|placebo: placebo
736471|NCT01666197|E1|Reported Event|Diclofenac Potassium 25 mg Tablet|diclofenac potassium 25 mg tablet: diclofenac potassium 25 mg tablet
736472|NCT01666119|B1|Baseline|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.~BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
736591|NCT01665157|B3|Baseline|Low-residue Diet (Enimaclin®) Package and 1.5L PEG|Low-residue diet package with normal amount of 1.5L PEG-ELS
736473|NCT01666119|P1|Participant Flow|BEMA Buprenorphine NX Films|"BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg).~BEMA Buprenorphine/NX films (3.5/0.6, 5.25/0.9, 7/1.2, 10.5/1.8, and 14/2.4 mg)."
736474|NCT01666119|O1|Outcome|BEMA Buprenorphine/NX Films|BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
736475|NCT01666119|O1|Outcome|BEMA Buprenorphine/NX Films|BEMA Buprenorphine/NX films (3.5/0.6mg, 5.25/0.9mg, 7.0/1.2mg, 10.5/1.7mg, 14.0/2.3mg)
736476|NCT01666119|E1|Reported Event|BEMA Buprenorphine NX Films|"BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone)will be provided in 3.361 and 5.447 cm2 film sizes, respectively.~BEMA Buprenorphine NX films: BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively."
736477|NCT01666002|B3|Baseline|Total|Total of all reporting groups
736478|NCT01666002|B2|Baseline|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
736479|NCT01666002|B1|Baseline|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
736480|NCT01666002|P2|Participant Flow|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
736481|NCT01666002|P1|Participant Flow|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~42 patients were assessed and 27 met eligibility criteria of a diagnosis of onychomycosis by clinical toenail morphology confirmed by positive culture."
736482|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
736483|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser"
736484|NCT01666002|O2|Outcome|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
736485|NCT01666002|O1|Outcome|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~After 3 months, 4 of 12 patients (33%) in the laser group had negative fungal cultures. Of the 4 patients in the laser group with baseline cultures positive for a non-dermatophyte mold, 2 (50%) had negative fungal cultures. After 3 months of observation, 2 of 10 (20%) control subjects had negative cultures. Of the 3 patients in the control group with baseline cultures positive for a non-dermatophyte mold, 1 (33%) had a negative fungal culture. There was no significant difference in the percentage of patients with negative nail cultures between laser versus control groups (P = .49)."
736486|NCT01666002|E2|Reported Event|Placebo|"st visit: For the control group, no treatment will be given.~nd visit: 2 weeks after initial visit, patient will be seen for second visit"
736487|NCT01666002|E1|Reported Event|Treatment|"st visit: Patient will come into clinic for initial laser treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~nd visit: 2 weeks after initial laser treatment, patient will be seen for second treatment with Nd:YAG 1064 nm laser fitted with special handpiece.~Laser Treatment (Pulsed Nd:YAG 1064 nm Laser): 0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser~No patients reported complications or adverse events after 2 sessions."
736488|NCT01665950|B4|Baseline|Total|Total of all reporting groups
736516|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
736489|NCT01665950|B3|Baseline|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736490|NCT01665950|B2|Baseline|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
736491|NCT01665950|B1|Baseline|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736502|NCT01665911|P1|Participant Flow|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
736492|NCT01665950|P3|Participant Flow|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736493|NCT01665950|P2|Participant Flow|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
736494|NCT01665950|P1|Participant Flow|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736495|NCT01665950|O3|Outcome|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736496|NCT01665950|O2|Outcome|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
736497|NCT01665950|O1|Outcome|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: Subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736498|NCT01665950|E3|Reported Event|Placebo-Placebo|"Placebo nonresponders for the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the subsequent 4 weeks~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736499|NCT01665950|E2|Reported Event|Placebo->Simvastatin|"Placebo non-responders after the 1st 4 weeks will be re-randomized 1:1 to placebo or simvastatin for the next 4 wks~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.~Placebo: Subjects are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results ar"
736500|NCT01665950|E1|Reported Event|Simvastatin-Simvastatin|"Subjects will receive simvastatin in phase 1 (4 weeks) and phase 2 (4 weeks)~Simvastatin: The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks."
736501|NCT01665911|B1|Baseline|All Participants|"1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design"
736525|NCT01665508|O2|Outcome|Baseline|results without nebivolol
738011|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
736503|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
736504|NCT01665911|O1|Outcome|All Participants|"Each subject will use each of these products during each of the five treatment periods in the crossover study design. There were five interventions as follows:~. 1.5 mg Sodium Fluoride in 100 ml milk: .~1.5 mg Sodium Fluoride in 200 ml milk~3.0 mg Sodium Fluoride in 100 ml milk~3.0 mg Sodium Fluoride in 200 ml milk~0 mg fluoride in 200 ml milk"
736505|NCT01665911|O1|Outcome|All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~Each of the subjects used all of the five inverventions listed above during this 5-period cross over study. Each subject had their own specific sequence of use."
736506|NCT01665911|E1|Reported Event|Arm/Group All Participants|"1.5 mg sodium fluoride in 100 ml milk 1.5 mg sodium fluoride in 200 ml milk 3 mg sodium fluoride in 100 ml milk 3 mg sodium fluoride in 200 ml milk non-fluoridated milk, 200 ml~1.5 mg Sodium Fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~1.5 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 100 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design.~3 mg sodium fluoride in 200 ml milk: Each subject will use this product during one of the five treatment periods in the crossover study design~Non-fluoridated milk, 200 ml: Each subject will use this product during one of the five treatment periods in the crossover study design."
736507|NCT01665807|B4|Baseline|Total|Total of all reporting groups
736508|NCT01665807|B3|Baseline|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736509|NCT01665807|B2|Baseline|Repeat Self-administered Intradermal|"Self-administration (2) of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736510|NCT01665807|B1|Baseline|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
736511|NCT01665807|P3|Participant Flow|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736512|NCT01665807|P2|Participant Flow|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736513|NCT01665807|P1|Participant Flow|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
736514|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736515|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736552|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736553|NCT01665170|O1|Outcome|Placebo|Placebo arm
736554|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736517|NCT01665807|O3|Outcome|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736518|NCT01665807|O2|Outcome|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736519|NCT01665807|O1|Outcome|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
736520|NCT01665807|E3|Reported Event|Self-administered Intradermal|"Self-administered intradermal influenza vaccine (Intanza 0.1 mL)~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736521|NCT01665807|E2|Reported Event|Repeat Self-administration Intradermal|"Self-administration of intradermal influenza vaccine (Intanza 0.1 mL) by participants who self-administered an intradermal vaccine in our 2010 study~Intanza : Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere"
736522|NCT01665807|E1|Reported Event|Nurse-administered IM|"Nurse-administered intramuscular influenza vaccine (Vaxigrip, 0.5 mL)~Vaxigrip : Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere"
736523|NCT01665508|B1|Baseline|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
736524|NCT01665508|P1|Participant Flow|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
736526|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~this data was incomplete and not useful for analysis"
736527|NCT01665508|O2|Outcome|Baseline|results prior to nebivolol start
736528|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)"
736529|NCT01665508|O2|Outcome|Baseline|results without nebivolol
736530|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~this data was incomplete and not useful for analysis"
736531|NCT01665508|O2|Outcome|Baseline|results off nebivolol
736532|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
736533|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~this data was incomplete and not useful for analysis"
736534|NCT01665508|O2|Outcome|Baseline|results off nebivolol
736535|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
736536|NCT01665508|O2|Outcome|Baseline|results prior to nebivolol start
736537|NCT01665508|O1|Outcome|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months~There was a significant improvement in angina stability (p=0.034) post treatment compared to baseline. The other parameter of the SAQ were not statistically different ( physical limitation, angina frequency, treatment satisfaction and quality of life)"
736538|NCT01665508|E1|Reported Event|Nebivolol|"Testing will be performed at baseline (SAQ questionnaire, cardiopulmonary testing, resource utilization, metabolomics and vascular testing). This will be repeated on the same group of patients after 3 months of nebivolol treatment.~Nebivolol: Patient to start nebivolol and have repeat testing in 3 months"
736539|NCT01665170|B3|Baseline|Total|Total of all reporting groups
736540|NCT01665170|B2|Baseline|Verum|Verum arm - Pascoflair 425mg
736541|NCT01665170|B1|Baseline|Placebo|Placebo arm
736542|NCT01665170|P2|Participant Flow|Verum|Verum arm - Pascoflair 425mg, 3 x 1 tablet per every day for 3 days
736543|NCT01665170|P1|Participant Flow|Placebo|Placebo arm, 3 x 1 tablet per every day for 3 days
736544|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736545|NCT01665170|O1|Outcome|Placebo|Placebo arm
736546|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736547|NCT01665170|O1|Outcome|Placebo|Placebo arm
736548|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736549|NCT01665170|O1|Outcome|Placebo|Placebo arm
736550|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736551|NCT01665170|O1|Outcome|Placebo|Placebo arm
736569|NCT01665170|O1|Outcome|Placebo|Placebo arm
736570|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736571|NCT01665170|O1|Outcome|Placebo|Placebo arm
736572|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736573|NCT01665170|O1|Outcome|Placebo|Placebo arm
736574|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736575|NCT01665170|O1|Outcome|Placebo|Placebo arm
736576|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736577|NCT01665170|O1|Outcome|Placebo|Placebo arm
736578|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736579|NCT01665170|O1|Outcome|Placebo|Placebo arm
736580|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736581|NCT01665170|O1|Outcome|Placebo|Placebo arm
736582|NCT01665170|O2|Outcome|Verum|Verum arm - Pascoflair 425mg
736583|NCT01665170|O1|Outcome|Placebo|Placebo arm
736584|NCT01665170|O2|Outcome|Placebo|Placebo arm
736593|NCT01665157|B1|Baseline|Low-residue Diet Package (Enimaclin®) and 2L PEG|Low-residue diet package with normal amount of 2L PEG-ELS
736594|NCT01665157|P3|Participant Flow|Low-residue Diet Package and 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
736595|NCT01665157|P2|Participant Flow|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
736596|NCT01665157|P1|Participant Flow|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736597|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
736598|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
736599|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736600|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with reduced volume 1.5L PEG-ELS
736601|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with 2L PEG-ELS
736602|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736603|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5 L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
736604|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
736605|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736606|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
736607|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
736608|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736609|NCT01665157|O3|Outcome|Low-residue Diet Package and 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
736610|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
736611|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736612|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with reduced volume low volume 1.5L PEG-ELS
736613|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
736614|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736615|NCT01665157|O3|Outcome|Low-residue Diet Package Plus 1.5L PEG|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
736616|NCT01665157|O2|Outcome|Self-controlled Diet and 2L PEG|Self-controlled diet with normal amount 2L PEG-ELS
736617|NCT01665157|O1|Outcome|Low-residue Diet Package and 2L PEG|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736618|NCT01665157|E3|Reported Event|Low-residue Diet Package Plus 1.5L PEG-ELS|Low-residue diet package(Enimaclin) with low volume 1.5L PEG-ELS
736619|NCT01665157|E2|Reported Event|Self-controlled Diet|Self-controlled diet with normal amount 2L PEG-ELS
736620|NCT01665157|E1|Reported Event|Low-residue Diet Package|Low-residue diet package (Enimaclin) with normal amount 2L PEG-ELS
736621|NCT01665053|B3|Baseline|Total|Total of all reporting groups
736622|NCT01665053|B2|Baseline|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736623|NCT01665053|B1|Baseline|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736624|NCT01665053|P2|Participant Flow|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736625|NCT01665053|P1|Participant Flow|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736626|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736627|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
813189|NCT01349829|O1|Outcome|HAVpur|
736628|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736629|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736630|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736675|NCT01664949|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736631|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736632|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736633|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736634|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736635|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736636|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736637|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736638|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736639|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736640|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736641|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736642|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736643|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736644|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736645|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736646|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736647|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736648|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736649|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736650|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736651|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736676|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736652|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736653|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736654|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736655|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736656|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736657|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736658|NCT01665053|O2|Outcome|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736659|NCT01665053|O1|Outcome|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736660|NCT01665053|E2|Reported Event|SYNERGY|"SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).~SYNERGY: A drug eluting coronary stent system"
736661|NCT01665053|E1|Reported Event|Promus Element Plus|"PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).~PROMUS Element Plus: A drug eluting coronary stent system"
736662|NCT01664975|B3|Baseline|Total|Total of all reporting groups
736663|NCT01664975|B2|Baseline|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
736664|NCT01664975|B1|Baseline|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
736665|NCT01664975|P2|Participant Flow|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
736666|NCT01664975|P1|Participant Flow|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
736667|NCT01664975|O2|Outcome|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
736668|NCT01664975|O1|Outcome|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
736669|NCT01664975|E2|Reported Event|CHOP Regimen|"CHOP(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) regimen~CHOP regimen: CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5."
736670|NCT01664975|E1|Reported Event|GDPT Regimen|"GDPT(gemcitabine,cisplatin,Prednisone,Thalidomide) regimen~GDPT regimen: GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles."
736671|NCT01664949|B3|Baseline|Total|Total of all reporting groups
736672|NCT01664949|B2|Baseline|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736673|NCT01664949|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736674|NCT01664949|P2|Participant Flow|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736677|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736678|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736679|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736680|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736681|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736682|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736683|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736684|NCT01664949|O2|Outcome|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736685|NCT01664949|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736686|NCT01664949|E2|Reported Event|OPTIVE™|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736687|NCT01664949|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
736688|NCT01664923|B3|Baseline|Total|Total of all reporting groups
736689|NCT01664923|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736690|NCT01664923|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736691|NCT01664923|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736692|NCT01664923|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736693|NCT01664923|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736694|NCT01664923|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736695|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736696|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736697|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736698|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736699|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736700|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736701|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736702|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736703|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736704|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736705|NCT01664923|O2|Outcome|Bicalutamide|Participants randomized to receive bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
736706|NCT01664923|O1|Outcome|Enzalutamide|Participants randomized to receive enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736707|NCT01664923|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg, self-administered as 1 capsule, once per day by mouth and 4 enzalutamide-placebo capsules.
737746|NCT01660802|B3|Baseline|Total|Total of all reporting groups
736708|NCT01664923|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, self-administered as four 40-mg capsules, once per day by mouth and 1 bicalutamide-placebo capsule.
736709|NCT01664806|B3|Baseline|Total|Total of all reporting groups
736710|NCT01664806|B2|Baseline|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
736711|NCT01664806|B1|Baseline|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
736743|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736712|NCT01664806|P2|Participant Flow|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
736713|NCT01664806|P1|Participant Flow|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
736714|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
736715|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
736716|NCT01664806|O2|Outcome|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
736717|NCT01664806|O1|Outcome|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
736718|NCT01664806|E2|Reported Event|Coag Mode 30 Watts Power|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power coag mode which is current standard of care.~Covidien FX monopolar generator - Coag Mode 30 Watts : 30 Watts coag mode will be used to perform laparoscopic cholecystectomy"
736719|NCT01664806|E1|Reported Event|Blend Mode (Triverse Pencil Valleylab Mode) 30 Watts|"Elective laparoscopic cholecystectomy will be performed with 30 Watts power blend mode (triverse pencil valleylab mode) which is the experimental arm of the study's mode.~Covidien Triad monopolar generator - Blend mode (triverse pencil valleylab mode) 30 Watts : Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy."
736720|NCT01664793|B3|Baseline|Total|Total of all reporting groups
736721|NCT01664793|B2|Baseline|Control Group|Children in 10 diverse pediatric and family practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
736722|NCT01664793|B1|Baseline|Intervention Group|Children in 10 diverse pediatric and family medicine practices. Baseline group are active patients of the practices with a visit between 3/1/2010 and 2/28/2011.
736723|NCT01664793|P2|Participant Flow|Control Group|Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the control group; n=38,626. They will receive the 4 Pillars Toolkit and early season vaccine in Year 2.
736724|NCT01664793|P1|Participant Flow|Intervention Group|"Children who are active patients of 10 diverse pediatric and family medicine practices and who had at least one visit between 3/1/2011 and 2/29/2012 will serve as the Intervention group; n=49,039.~Intervention sites will use the 4 Pillars toolkit along with early season vaccine to promote increases in childhood influenza vaccination."
736725|NCT01664793|O2|Outcome|Control Group|This group did not rate effectiveness of the intervention.
736726|NCT01664793|O1|Outcome|Intervention Group|2 respondents in each of 10 diverse pediatric and family medicine practices.
736727|NCT01664793|O2|Outcome|Control Group|Children with a visit between 3/1/2011 and 2/29/2012 in 10 diverse pediatric and family practices.
736728|NCT01664793|O1|Outcome|Intervention Group|Children seen in 10 diverse pediatric and family medicine practices between 3/1/2011 and 2/29/2012.
736729|NCT01664793|E2|Reported Event|Control Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
736730|NCT01664793|E1|Reported Event|Intervention Group|Children in 10 diverse pediatric and family medicine practices seen between 8/1/2011 and 2/29/2012. We used the number of children who were vaccinated during intervention as the denominator for adverse events, because there is no other study-related risk for non-vaccinated children.
736731|NCT01664624|B5|Baseline|Total|Total of all reporting groups
736732|NCT01664624|B4|Baseline|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736733|NCT01664624|B3|Baseline|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736734|NCT01664624|B2|Baseline|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736735|NCT01664624|B1|Baseline|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736736|NCT01664624|P4|Participant Flow|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736737|NCT01664624|P3|Participant Flow|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736738|NCT01664624|P2|Participant Flow|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736739|NCT01664624|P1|Participant Flow|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736740|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736741|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736742|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736744|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736745|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736746|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736747|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736748|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736749|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736750|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736751|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736752|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736753|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736754|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736755|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736756|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736757|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736758|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736759|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736760|NCT01664624|O4|Outcome|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736761|NCT01664624|O3|Outcome|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736762|NCT01664624|O2|Outcome|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736763|NCT01664624|O1|Outcome|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736764|NCT01664624|E4|Reported Event|Exenatide|Exenatide 5 μg subcutaneous injection twice a day for 11 days.
736765|NCT01664624|E3|Reported Event|Roflumilast Alone|Roflumilast 500 μg, tablets, orally and placebo to alogliptin, tablets, orally, once a day, for 11 days.
736766|NCT01664624|E2|Reported Event|Alogliptin Alone|Placebo to roflumilast, tablets, orally and alogliptin, 25 mg, tablets, orally, once a day for 11 days.
736767|NCT01664624|E1|Reported Event|Roflumilast + Alogliptin|Roflumilast 500 μg, tablets, orally and alogliptin 25 mg, tablets, orally, once a day for 11 days.
736768|NCT01664559|B3|Baseline|Total|Total of all reporting groups
736769|NCT01664559|B2|Baseline|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736770|NCT01664559|B1|Baseline|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736771|NCT01664559|P2|Participant Flow|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736772|NCT01664559|P1|Participant Flow|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736773|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736774|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736775|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736776|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736777|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736835|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736778|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736779|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736780|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736781|NCT01664559|O2|Outcome|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736782|NCT01664559|O1|Outcome|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736783|NCT01664559|E2|Reported Event|Toradol, 30mg in 1cc IM|"If the patient is randomized to the toradol (ketorolac) arm, they will receive 30mg of toradol in a 1cc volume via the intramuscular route.~Ketorolac: Ketorolac 30mg intramuscular injection, 1cc volume"
736784|NCT01664559|E1|Reported Event|Placebo With 1cc Normal Saline IM|"If the patient is randomized to the placebo arm, they will receive 1cc of normal saline via the intramuscular route.~Normal Saline: Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection"
736785|NCT01664533|B1|Baseline|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
736786|NCT01664533|P1|Participant Flow|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
736787|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
736788|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
736789|NCT01664533|O1|Outcome|Erlotinib|"Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.~Erlotinib: Erlotinib was supplied as tablets in the retail product Tarceva."
736790|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
736791|NCT01664533|O1|Outcome|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
736792|NCT01664533|E1|Reported Event|Erlotinib|Selection of the dose of erlotinib most suitable for each participant was left to the discretion of the physician, guided by the recommendation in the Summary of Product Characteristics. The recommended daily oral dose of erlotinib is 150 mg.
736793|NCT01664494|B1|Baseline|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
736794|NCT01664494|P1|Participant Flow|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
736795|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
736796|NCT01664494|O1|Outcome|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
736797|NCT01664494|E1|Reported Event|Capecitabine|Participants received capecitabine according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
736798|NCT01664247|B3|Baseline|Total|Total of all reporting groups
736799|NCT01664247|B2|Baseline|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736800|NCT01664247|B1|Baseline|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736801|NCT01664247|P2|Participant Flow|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736802|NCT01664247|P1|Participant Flow|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736803|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736847|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736804|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736805|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736806|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736807|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736808|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736809|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736810|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736811|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736812|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736813|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736836|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736837|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736838|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736814|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736815|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736848|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736849|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736850|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736851|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736816|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736817|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736818|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736819|NCT01664247|O2|Outcome|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736820|NCT01664247|O1|Outcome|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736821|NCT01664247|E2|Reported Event|Placebo|Placebo treatment (3 mL prefilled pen) in combination with Liraglutide (Lira,1.8 mg/daily, 3 mL prefilled pen) once daily was given subcutaneously (under the skin) in the thigh, abdomen or upper arm (deltoid) at any time of the day according to the subject’s choice for 26 weeks of treatment period. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736822|NCT01664247|E1|Reported Event|IDeg|Liraglutide treatment was initiated on 0.6 mg daily for one week and increased further after the second week in the run-in period. In the randomized period, Insulin degludec (IDeg, 100 U/mL, in a 3 mL prefilled pen PDS290) treatment was recommended to be initiated and administered subcutaneously (under the skin) once daily (OD) with 10 units. After that it was titrated once weekly. If one or more of the pre-breakfast plasma glucose values were below a certain range, the subjects were to reduce the insulin dose. Subjects continued on metformin (1500/day) treatment at the stable, pre-trial dose and maintained dosing frequency levels throughout the trial period.
736823|NCT01664117|B1|Baseline|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
736824|NCT01664117|P1|Participant Flow|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
736825|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736826|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736827|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
736828|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
736829|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
736830|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
736831|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
736832|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
736833|NCT01664117|O2|Outcome|Other Treatments|Participants on Other treatments for RA in routine clinical practice.
736834|NCT01664117|O1|Outcome|Tocilizumab|Participants on tocilizumab for RA in routine clinical practice.
736839|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736840|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736841|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736842|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736843|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736844|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736845|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736846|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
745854|NCT01627002|O6|Outcome|Part A Placebo|
736852|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736853|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736854|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736855|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736856|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736857|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736858|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736859|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736860|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736861|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for rheumatoid arthritis (RA) in routine clinical practice.
736862|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736863|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736864|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736865|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736866|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736867|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736868|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736869|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736870|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736871|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736872|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736873|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736874|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736875|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736876|NCT01664117|O1|Outcome|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736877|NCT01664117|E1|Reported Event|bDMARD Monotherapy|Participants on bDMARD monotherapy for RA in routine clinical practice.
736878|NCT01664052|B3|Baseline|Total|Total of all reporting groups
736879|NCT01664052|B2|Baseline|ESS305/ESS505|Unilateral placement of Essure 505 (BAY1454033) insert (PET-inclusive) and Contralateral placement of the current commercial Essure device Essure 305 (BAY1454032)
736880|NCT01664052|B1|Baseline|ESS505-A|Bilateral placement of Essure 505A (BAY1454033) insert (with minimal PET fiber).
736881|NCT01664052|P2|Participant Flow|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736882|NCT01664052|P1|Participant Flow|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
736883|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736940|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
738299|NCT01658657|B3|Baseline|Total|Total of all reporting groups
736884|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736885|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
736898|NCT01664039|B2|Baseline|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736886|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736887|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736888|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
736889|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736890|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736891|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
736892|NCT01664052|O3|Outcome|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736893|NCT01664052|O2|Outcome|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736894|NCT01664052|O1|Outcome|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
736895|NCT01664052|E2|Reported Event|ESS 305/ESS 505 (Essure, BAY1454032/Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
736896|NCT01664052|E1|Reported Event|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects’ scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
736897|NCT01664039|B3|Baseline|Total|Total of all reporting groups
736899|NCT01664039|B1|Baseline|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736900|NCT01664039|P2|Participant Flow|LUMIGAN|One drop to the study eye(s) once a day in the evening, for 6 months
736901|NCT01664039|P1|Participant Flow|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736902|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736903|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736904|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736905|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736906|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736907|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736908|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736909|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736910|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736911|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736912|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736913|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736914|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736915|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736916|NCT01664039|O2|Outcome|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736917|NCT01664039|O1|Outcome|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736918|NCT01664039|E2|Reported Event|LUMIGAN|One drop to the study eye(s) once a day in the evening for 6 months
736919|NCT01664039|E1|Reported Event|TRAVATAN|One drop to the study eye(s) once a day in the evening for 6 months
736920|NCT01663987|B3|Baseline|Total|Total of all reporting groups
736921|NCT01663987|B2|Baseline|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736922|NCT01663987|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736923|NCT01663987|P2|Participant Flow|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736924|NCT01663987|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736925|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736926|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736927|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736928|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736929|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736930|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736931|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736932|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736933|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736934|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736935|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736936|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736937|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736938|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736939|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
744784|NCT01632709|B3|Baseline|Neuroma Injection of Bupivacaine|
736941|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736942|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736943|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736944|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736945|NCT01663987|O2|Outcome|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736946|NCT01663987|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
736947|NCT01663987|E2|Reported Event|Tiotropium Bromide (18μg)|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
738012|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
736948|NCT01663987|E1|Reported Event|Placebo|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
736949|NCT01663922|B1|Baseline|All Participants|Descriptive analysis of combined groups
736950|NCT01663922|P2|Participant Flow|Group B (Boceprevir Then St John's Wort)|"Boceprevir for 5 days (10-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)~SJW from day 43 to day 56"
736951|NCT01663922|P1|Participant Flow|Group A (St John's Wort Then Boceprevir)|"St John’s Wort, (SJW) for 14 days (1-14)~[wash out for 7 days (15-21)]~SJW for 14 days (22-35) plus boceprevir from day 31 to day 35 (5 days in total)~[wash out for 7 days (36-42)]~boceprevir from day 52 to day 56"
736952|NCT01663922|O1|Outcome|All Participants|Combined analysis of both group sequences
736953|NCT01663922|E2|Reported Event|Group B|Boceprevir first
736954|NCT01663922|E1|Reported Event|Group A|St John's Wort first
736955|NCT01663779|B3|Baseline|Total|Total of all reporting groups
736956|NCT01663779|B2|Baseline|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
736957|NCT01663779|B1|Baseline|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
736958|NCT01663779|P2|Participant Flow|Palpation Based Artery Catheterization|"Blind insertion of radial artery catheterization~Blind insertion of radial artery catheterization: Radial artery catheters will be placed by the palpation technique only."
736959|NCT01663779|P1|Participant Flow|Ultrasound Radial Artery Catheter|"Ultrasound guided radial artery catheterization.~Ultrasound guided radial artery catheterization.: Radial artery catheters will be placed with the assistance of bedside ultrasound."
736960|NCT01663779|O2|Outcome|Palpation|palpation artery
736961|NCT01663779|O1|Outcome|Ultrasound|ultrasound atery
736962|NCT01663779|E2|Reported Event|Palpation|palpation artery
736963|NCT01663779|E1|Reported Event|Ultrasound|ultrasound artery
736964|NCT01663727|B3|Baseline|Total|Total of all reporting groups
736965|NCT01663727|B2|Baseline|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736966|NCT01663727|B1|Baseline|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736967|NCT01663727|P2|Participant Flow|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 milligram per kilogram (mg/kg) on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736968|NCT01663727|P1|Participant Flow|Paclitaxel+Placebo|Participants received paclitaxel 90 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736969|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736970|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736971|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736972|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736973|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736974|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736975|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736976|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
737184|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
736977|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736978|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736979|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736980|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736981|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
737116|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
736982|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736983|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736984|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736985|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736986|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736987|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736988|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736989|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736990|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736991|NCT01663727|O2|Outcome|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736992|NCT01663727|O1|Outcome|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736993|NCT01663727|E2|Reported Event|Paclitaxel+ Bevacizumab|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and bevacizumab IV 10 mg/kg on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736994|NCT01663727|E1|Reported Event|Paclitaxel+Placebo|Participants received paclitaxel 90 mg/m^2 IV on Days 1, 8 and 15 and placebo matched to bevacizumab IV infusion on Days 1 and 15 of a 28 day cycle until progressive disease, treatment limiting toxicity or death.
736995|NCT01663714|B1|Baseline|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
736996|NCT01663714|P1|Participant Flow|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemotherapy (chemo.): oral Cyclophosphamide (400 milligrams/meters squared [mg/m^2]/day) for 1-5 days; intravenous (IV) Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737021|NCT01663714|E1|Reported Event|Period After CVP|Par. received 6 cycles of chemotherapy as follows: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; intravenous Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days
737022|NCT01663532|B3|Baseline|Total|Total of all reporting groups
737023|NCT01663532|B2|Baseline|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
736997|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
736998|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737046|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
736999|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737000|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737001|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737002|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737003|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737004|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737185|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
813190|NCT01349829|O2|Outcome|Havrix|
737005|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737006|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737047|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737241|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737007|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737008|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737009|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737010|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737011|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737012|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737013|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737014|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737048|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
738013|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
737015|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737016|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737017|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737018|NCT01663714|O1|Outcome|Chemotherapy; TST and Iodine I 131 TST|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737019|NCT01663714|E3|Reported Event|Combined Regimen Period|Par. received 6 cycles of chemo.: oral Cyclophosphamide (400 mg/m^2/day) for 1-5 days; IV Vincristine (1.4 mg/m^2) on Day 1; oral Prednisone (100 mg/m^2/day) for 1-5 days. Par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled TST (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi Iodine 131. Par. received 4 DBM TID of KI and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the TD: a 1 hour IV infusion of 450 mg TST, followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose. Par. completing 2 years of the study could enter a 10-year Long-Term Follow-Up study (BEX104528) in which no study medication was given.
737020|NCT01663714|E2|Reported Event|Period After Dosimetric and Therapeutic Dose|After receiving Cyclophosphamide, Vincristine, and Prednisone, par. received the DD 4-8 weeks after Day 1 of Cycle 6 of chemo. Unlabeled tositumomab (TST) (450 mg) was infused IV for 1 hour prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) Iodine 131. Par. received 4 drops by mouth (DBM) 3 times a day (TID) of potassium iodide (KI) and 20 DBM TID Lugol's solution or KI tablets (130 mg BM, daily) >=24 hours prior to DD administration.Treatment continued daily for 14 days after the therapeutic dose (TD: a 1 hour IV infusion of 450 mg TST), followed by an infusion of 35 mg TST radiolabeled with Iodine I 131 to deliver a 75 centiGray total body radiation dose.
737229|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737024|NCT01663532|B1|Baseline|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737025|NCT01663532|P2|Participant Flow|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737026|NCT01663532|P1|Participant Flow|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737027|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737117|NCT01663103|O4|Outcome|Placebo: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
737028|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737029|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737030|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737031|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737032|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737033|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737034|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737035|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737036|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737037|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737038|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737039|NCT01663532|O2|Outcome|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737040|NCT01663532|O1|Outcome|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737041|NCT01663532|E2|Reported Event|Placebo|Participants randomized to Placebo group received matching placebo. For 14 days beginning with the first injection, participants received concomitant oral placebo.
737042|NCT01663532|E1|Reported Event|Aripiprazole IM Depot 400/300mg|Participants randomized to aripiprazole IM depot received aripiprazole IM depot 400 mg as the initial dose with a single decrease to aripiprazole IM depot 300 mg permitted for tolerability per the study physician. The study treatment was injected into gluteal muscle every 4 weeks (Baseline/Day, Week 4, Week 8) during the 12-Week Acute Treatment Phase (ie, 3 IM depot injections). For 14 days beginning with the first injection, participants received concomitant oral aripiprazole (10 to 20 mg/day based on the study physician's clinical judgment).
737043|NCT01663506|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737044|NCT01663506|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab (RoActemra/Actemra) treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737045|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
738014|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
737049|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737050|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737051|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737052|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737053|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737054|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737055|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737056|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737057|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737058|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737059|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737060|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737061|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737062|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737063|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737064|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737747|NCT01660802|B2|Baseline|Sham|Sham administered in the study eye on Day 1.
737065|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737066|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737067|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737068|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737069|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
738015|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
737070|NCT01663506|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737071|NCT01663506|E1|Reported Event|Tocilizumab|Participants with moderate to severe rheumatoid arthritis, in whom treating physician had made a decision to commence tocilizumab treatment according to local labeling (including participants who had started tocilizumab treatment within 8 weeks before enrollment) were observed prospectively for 12 months.
737072|NCT01663363|B1|Baseline|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
737073|NCT01663363|P1|Participant Flow|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
737074|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
737075|NCT01663363|O1|Outcome|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
737076|NCT01663363|E1|Reported Event|Wavefront-guided LASIK|LASIK correction of myopic refractive errors: Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System.
737077|NCT01663285|B1|Baseline|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
737078|NCT01663285|P1|Participant Flow|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
737079|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
737080|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
737081|NCT01663285|O1|Outcome|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
737082|NCT01663285|E1|Reported Event|Neoadjuvant Gemcitabine and Cisplatin|Neoadjuvant Cisplatin and Gemcitabine: Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
737083|NCT01663233|B3|Baseline|Total|Total of all reporting groups
737084|NCT01663233|B2|Baseline|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737085|NCT01663233|B1|Baseline|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737086|NCT01663233|P2|Participant Flow|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
813191|NCT01349829|O1|Outcome|HAVpur|
737087|NCT01663233|P1|Participant Flow|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737088|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737089|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737090|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737091|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
738016|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
737092|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737093|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737094|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737095|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737096|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737097|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737098|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737099|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737100|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737101|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737102|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737103|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737104|NCT01663233|O2|Outcome|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737105|NCT01663233|O1|Outcome|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737106|NCT01663233|E2|Reported Event|Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.
737286|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
737107|NCT01663233|E1|Reported Event|LCZ696 and Amlodipine|Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (an office msSBP ≥145 mmHg and <180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
737108|NCT01663103|B3|Baseline|Total|Total of all reporting groups
737109|NCT01663103|B2|Baseline|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
737110|NCT01663103|B1|Baseline|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
737111|NCT01663103|P2|Participant Flow|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
737112|NCT01663103|P1|Participant Flow|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
737113|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
737114|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
737115|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
737118|NCT01663103|O3|Outcome|Placebo: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the placebo group at baseline
737119|NCT01663103|O2|Outcome|Rilonacept: End of Study|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at 12 weeks.
737120|NCT01663103|O1|Outcome|Rilonacept: Baseline|Change in flow-mediated dilation following an acute infusion of ascorbic acid (as compared to saline) in the rilonacept group at baseline.
737121|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
737122|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
737123|NCT01663103|O2|Outcome|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
737124|NCT01663103|O1|Outcome|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
737125|NCT01663103|E2|Reported Event|Placebo|"Twelve weeks of treatment with placebo~Placebo: Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)"
737126|NCT01663103|E1|Reported Event|Rilonacept|"12 weeks of treatment with rilonacept~Rilonacept: 12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)"
737127|NCT01663012|B1|Baseline|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
737128|NCT01663012|P1|Participant Flow|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
737129|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
737130|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
737131|NCT01663012|O1|Outcome|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
737132|NCT01663012|E1|Reported Event|Drug: Etirinotecan Pegol|"145 mg/m2 dose~Etirinotecan pegol"
737133|NCT01662999|B7|Baseline|Total|Total of all reporting groups
737134|NCT01662999|B6|Baseline|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
737135|NCT01662999|B5|Baseline|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
737136|NCT01662999|B4|Baseline|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
737137|NCT01662999|B3|Baseline|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
737138|NCT01662999|B2|Baseline|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
737139|NCT01662999|B1|Baseline|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
737140|NCT01662999|P6|Participant Flow|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet"
737141|NCT01662999|P5|Participant Flow|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|"Single dose of:~Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
737142|NCT01662999|P4|Participant Flow|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral"
737143|NCT01662999|P3|Participant Flow|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
737144|NCT01662999|P2|Participant Flow|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral"
737145|NCT01662999|P1|Participant Flow|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|"Single dose of:~Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral"
737146|NCT01662999|O6|Outcome|C-B-A: (Saxagliptin+Dapagliflozin)-Dapagliflozin-Saxagliptin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
737147|NCT01662999|O5|Outcome|C-A-B: (Saxagliptin+Dapagliflozin)-Saxagliptin-Dapagliflozin|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets,Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
737148|NCT01662999|O4|Outcome|B-C-A: Dapagliflozin-(Saxagliptin+Dapagliflozin)-Saxagliptin|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral.
737149|NCT01662999|O3|Outcome|B-A-C: Dapagliflozin-Saxagliptin-(Saxagliptin+Dapagliflozin)|Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral
737150|NCT01662999|O2|Outcome|A-C-B: Saxagliptin-(Saxagliptin+Dapagliflozin)-Dapagliflozin|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral.
737240|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737151|NCT01662999|O1|Outcome|A-B-C: Saxagliptin-Dapagliflozin-(Saxagliptin+Dapagliflozin)|Treatment A: Saxagliptin 5mg, Tablet, Oral; Treatment B: Dapagliflozin 10mg, Tablet, Oral; Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral.
737152|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
737153|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
737154|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
737155|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737156|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin
737157|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
737158|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
737159|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
737160|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
737161|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
737162|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
737163|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
737164|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
737165|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
737166|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
737167|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
737168|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Single dose oral tablet of 10 mg dapagliflozin.
737169|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
737170|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet 5mg saxagliptin.
737171|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|A single oral tablet dose of 10 mg Dapagliflozin.
737172|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Single dose oral tablet of 5 mg saxagliptin.
737173|NCT01662999|O3|Outcome|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin..
737174|NCT01662999|O2|Outcome|Treatment B: Dapagliflozin 10mg|Treatment B: A single oral tablet dose of 10 mg Dapagliflozin.
737175|NCT01662999|O1|Outcome|Treatment A: Saxagliptin 5mg|Treatment A: Single dose oral tablet of 5 mg saxagliptin..
737176|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737177|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
737178|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737179|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
737180|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737181|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single saxagliptin 5mg, Tablet, Oral.
737182|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737183|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose oral tablet of 5 mg saxagliptin.
744785|NCT01632709|B2|Baseline|Dry Needling at Sympathetic Ganglion|
737186|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737187|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
737188|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737189|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
737190|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737191|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
737192|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737193|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: single dose of Saxagliptin 5mg, Tablet, Oral.
737194|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737195|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg dapagliflozin.
745855|NCT01627002|O5|Outcome|Part A PA401 10 mg|
737196|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737197|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
737198|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737199|NCT01662999|O1|Outcome|5 mg Saxagliptin|Treatment A: Single dose Saxagliptin 5mg, Tablet, Oral.
737200|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737201|NCT01662999|O1|Outcome|10mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
737202|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737203|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
737204|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737205|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
737206|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737207|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin.
737208|NCT01662999|O2|Outcome|5 mg Saxagliptin + 10 mg Dapagliflozin|Treatment C: Co-administration of a single dose oral tablet of 10 mg Dapagliflozin plus a single dose of oral tablet of 5mg saxagliptin.
737209|NCT01662999|O1|Outcome|10 mg Dapagliflozin|Treatment B: Single dose oral tablet of 10 mg Dapagliflozin
737210|NCT01662999|E3|Reported Event|Treatment C: Saxagliptin 5 mg + Dapagliflozin 10 mg|Saxagliptin 5 mg + Dapagliflozin 10 mg, Tablets, Oral, Once daily, 1 day in each of 3 periods.
737211|NCT01662999|E2|Reported Event|Treatment B: Dapagliflozin 10mg|Dapagliflozin 10mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
737212|NCT01662999|E1|Reported Event|Treatment A: Saxagliptin 5mg|Saxagliptin 5mg, Tablet, Oral, Once daily, 1 day in each of 3 periods.
737213|NCT01662986|B3|Baseline|Total|Total of all reporting groups
737214|NCT01662986|B2|Baseline|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737215|NCT01662986|B1|Baseline|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737216|NCT01662986|P2|Participant Flow|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737217|NCT01662986|P1|Participant Flow|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737218|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737219|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737220|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737221|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737222|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737223|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737224|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737225|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737226|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737227|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737228|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
744786|NCT01632709|B1|Baseline|Sympathetic Nerve Block of Bupivacaine|
737230|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737231|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737232|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737233|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737234|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737235|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737236|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737237|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737238|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737239|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737242|NCT01662986|O2|Outcome|Tiotropium Bromide (18 μg)|Patient to receive oral inhalation of one tiotropium bromide powder capsule once daily in the morning via HandiHaler.
737243|NCT01662986|O1|Outcome|Placebo|Patient to receive oral inhalation of one placebo powder capsule once daily in the morning via HandiHaler.
737244|NCT01662986|E2|Reported Event|Tiotropium Bromide (18 μg)|Patient to receive one tiotropium bromide inhalation powder capsule once daily in the morning via HandiHaler
737245|NCT01662986|E1|Reported Event|Placebo|Patient to receive one placebo inhalation powder capsule once daily in the morning via HandiHaler
737246|NCT01662908|B3|Baseline|Total|Total of all reporting groups
737247|NCT01662908|B2|Baseline|Warfarin|Participants treated with warfarin
737248|NCT01662908|B1|Baseline|Edoxaban|Participants treated with edoxaban
737249|NCT01662908|P2|Participant Flow|Warfarin|Participants treated with warfarin
737250|NCT01662908|P1|Participant Flow|Edoxaban|Participants treated with edoxaban
737251|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
737252|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
737253|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
737254|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
737255|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
737256|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
737257|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
737258|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
737259|NCT01662908|O2|Outcome|Warfarin|Participants treated with warfarin
737260|NCT01662908|O1|Outcome|Edoxaban|Participants treated with edoxaban
737261|NCT01662908|E2|Reported Event|Warfarin|Participants treated with warfarin
737262|NCT01662908|E1|Reported Event|Edoxaban|Participants treated with edoxaban
737263|NCT01662882|B4|Baseline|Total|Total of all reporting groups
737264|NCT01662882|B3|Baseline|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
737265|NCT01662882|B2|Baseline|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737266|NCT01662882|B1|Baseline|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737267|NCT01662882|P3|Participant Flow|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
737268|NCT01662882|P2|Participant Flow|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737269|NCT01662882|P1|Participant Flow|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737270|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737271|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
737272|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737273|NCT01662882|O3|Outcome|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737274|NCT01662882|O2|Outcome|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
737275|NCT01662882|O1|Outcome|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737276|NCT01662882|E3|Reported Event|Healthy Controls|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737277|NCT01662882|E2|Reported Event|MCI Subjects|"MCI (mild cognitive impairment)~florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose"
737278|NCT01662882|E1|Reported Event|AD Subjects|florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
737279|NCT01662856|B3|Baseline|Total|Total of all reporting groups
737280|NCT01662856|B2|Baseline|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
737281|NCT01662856|B1|Baseline|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
737282|NCT01662856|P2|Participant Flow|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
737283|NCT01662856|P1|Participant Flow|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
737284|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
737285|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
737287|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
737288|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
737289|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
737290|NCT01662856|O2|Outcome|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
737291|NCT01662856|O1|Outcome|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
737292|NCT01662856|E2|Reported Event|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
737293|NCT01662856|E1|Reported Event|Fibrin Sealant Grifols|Fibrin Sealant Grifols consisting of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to target bleeding site.
737294|NCT01662791|B3|Baseline|Total|Total of all reporting groups
737295|NCT01662791|B2|Baseline|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737296|NCT01662791|B1|Baseline|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737297|NCT01662791|P2|Participant Flow|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day; they did not take part in the second part of the study.
737298|NCT01662791|P1|Participant Flow|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO twice a day (BID) for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737299|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737300|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737301|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737302|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737303|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737304|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737305|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737306|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737307|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737308|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737309|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737310|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737311|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737349|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
738017|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
737312|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737313|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737314|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737315|NCT01662791|O2|Outcome|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737316|NCT01662791|O1|Outcome|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737317|NCT01662791|E2|Reported Event|Control Group|This arm consisted of subjects with Parkinson's Disease who had not experienced significant weight loss. These patients were in the study for one day.
737318|NCT01662791|E1|Reported Event|Case Group|"All individuals in the Case group (i.e., only the subjects who had lost weight) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Subjects in the case group were in the study for 3 months.~Rifaximin: All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment did not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment."
737319|NCT01662765|B3|Baseline|Total|Total of all reporting groups
737320|NCT01662765|B2|Baseline|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
737321|NCT01662765|B1|Baseline|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry."
737322|NCT01662765|P2|Participant Flow|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
737323|NCT01662765|P1|Participant Flow|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
737324|NCT01662765|O2|Outcome|Surgery|Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
737325|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
737368|NCT01662583|B1|Baseline|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
737326|NCT01662765|O2|Outcome|Surgery|Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.
737327|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
737328|NCT01662765|O2|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
737329|NCT01662765|O1|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination.~Surgery: modified umbilectomy"
737330|NCT01662765|O2|Outcome|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture. The specimen, including the umbilical complex (pilonidal cyst, and involved skin and subcutaneous tissue), was transferred to department of pathology for histopathological examination."
737331|NCT01662765|O1|Outcome|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus.~postoperative management include antibiotic treatment with ampicilline plus sulbactam and ornidazole, shaving surrounding skin, washing twice daily, and keeping umbilicus dry.~conservative: this treatment will include conservative procedures under local anesthesia for patient comfort."
737332|NCT01662765|E2|Reported Event|Surgery|"Circular incision 2-3 mm below the skin level in the umbilicus through the subcutaneous fat towards the linea alba. Dissection of the subcutaneous tissue within the umbilicus and its deep connection to preperitoneal fat through the linea alba. Excision of the umbilical complex containing pilonidal cyst 3 mm below the umbilical ostium.~Approximation of the subcutaneous tissue with a single purse-string absorbable suture."
737333|NCT01662765|E1|Reported Event|Conservative|"Conservative treatment described as follow:~Under local anesthesia, extracting all protruding hair, and curetting the granulation tissue and pilonidal cyst deep in the umbilicus."
737334|NCT01662648|B3|Baseline|Total|Total of all reporting groups
737335|NCT01662648|B2|Baseline|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737336|NCT01662648|B1|Baseline|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737337|NCT01662648|P2|Participant Flow|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737338|NCT01662648|P1|Participant Flow|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737339|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737340|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737341|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737342|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737343|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737344|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
744787|NCT01632709|P4|Participant Flow|Dry Needling at the Neuroma|
737345|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737346|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737347|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737348|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737430|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737350|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737351|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737352|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737353|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737354|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737355|NCT01662648|O2|Outcome|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737356|NCT01662648|O1|Outcome|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737357|NCT01662648|E2|Reported Event|Paliperidone ER: Lack of Tolerability, Compliance or Other|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
737358|NCT01662648|E1|Reported Event|Paliperidone ER: Lack of Efficacy|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator’s discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.
737359|NCT01662635|B1|Baseline|Demographics and Clinical Features of Overall Population|The baseline characteristics of our population were on basis of the presence or absence of ALK gene.
737360|NCT01662635|P1|Participant Flow|Determination of ALK by FISH, IHC and RT-qPCR|"The only inclusion criterion was the availability of tissue for biomarker studies.~We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); using the commercially mouse monoclonal ALK antibody for IHC and . Variants 1, 2, 3a, 4 and 5. The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies)"
737361|NCT01662635|O3|Outcome|RT-qPCR Test|The qPCR reactions were performed using the TaqMan Universal PCR MasterMix (Applied Biosystems/TaqMan, Life Technologies) and the following Taqman assays: Hs03654556_ft (E13;A20), Hs03654557_ft (E20;A20), Hs03654558_ft (E6;A20), Hs03654560_ft (E17;A20), and Hs03654559_ft (E18;A20). Hs02758991_ft (GAPDH) assays, whose expression levels are known to be nearly stable among lung tumors
737362|NCT01662635|O2|Outcome|IHC Test|using the commercially mouse monoclonal ALK antibody (dilution 1:25, clone 5A4; Abcam, Cambridge, UK), with OptiView DAB detection Kit (Ventana, Tucson, Arizona, USA). ALK IHC was performed according to the protocols provided by the antibody.
737363|NCT01662635|O1|Outcome|FISH Test|We use a commercially available break-apart probe kit specific to the ALK locus (Vysis LSI ALK Dual Color (split-apart); Abbott Molecular, Abbott Park, IL, USA). Slide washing, and counterstaining by DAPI were done following the manufacturer´s protocol (Abbott Molecular, Abbott Park, IL, USA).
737364|NCT01662635|E1|Reported Event|Adverse Events Not Collected|"Serious and Other were not collected/assessed in this observational study."
737365|NCT01662583|B4|Baseline|Total|Total of all reporting groups
737366|NCT01662583|B3|Baseline|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
737367|NCT01662583|B2|Baseline|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
744788|NCT01632709|P3|Participant Flow|Neuroma Injection of Bupivacaine|
737369|NCT01662583|P3|Participant Flow|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
737370|NCT01662583|P2|Participant Flow|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
737371|NCT01662583|P1|Participant Flow|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
737372|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
737373|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
737374|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
737375|NCT01662583|O3|Outcome|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
737376|NCT01662583|O2|Outcome|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
737377|NCT01662583|O1|Outcome|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
737378|NCT01662583|E3|Reported Event|Written Reminder Only|"written reminder at time of vaccination~Written reminder"
737379|NCT01662583|E2|Reported Event|Plain Text Message|"plain text message reminder~Text Message~Written reminder"
737380|NCT01662583|E1|Reported Event|Educational Text Message|"Educational text message reminder~Text Message~Written reminder"
737381|NCT01662531|B3|Baseline|Total|Total of all reporting groups
737382|NCT01662531|B2|Baseline|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737383|NCT01662531|B1|Baseline|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737384|NCT01662531|P1|Participant Flow|rIX-FP|"Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP) will be administered by IV infusion as routine weekly prophylaxis and episodic treatment for bleeding episodes.~rIX-FP: Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)"
737385|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737386|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737387|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737388|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737389|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737390|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737391|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737392|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737393|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737394|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737395|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737396|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737397|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
745168|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
737398|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737399|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737400|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737401|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737402|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737403|NCT01662531|O3|Outcome|Age 6 to <12 Years|"Subjects between 6 and less than 12 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737404|NCT01662531|O2|Outcome|Age < 6 Years|"Subjects less than 6 years of age who received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737405|NCT01662531|O1|Outcome|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737406|NCT01662531|E1|Reported Event|rIX-FP|"All subjects received a single dose of 50 IU/kg rIX-FP on Day 1 during the pharmacokinetic phase of the study.~Subjects received weekly (7-day) routine prophylaxis treatment with an initial weekly dose of 35 to 50 IU/kg rIX-FP, which may have been adjusted based on protocol-specified criteria."
737407|NCT01662440|B5|Baseline|Total|Total of all reporting groups
737408|NCT01662440|B4|Baseline|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737409|NCT01662440|B3|Baseline|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
737410|NCT01662440|B2|Baseline|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737411|NCT01662440|B1|Baseline|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737412|NCT01662440|P4|Participant Flow|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737413|NCT01662440|P3|Participant Flow|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
737414|NCT01662440|P2|Participant Flow|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737415|NCT01662440|P1|Participant Flow|R/JE – Conv|Subjects received Rabies and Japanese Encephalitis (JE) vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737416|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737417|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
737418|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737419|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737420|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737421|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737422|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737748|NCT01660802|B1|Baseline|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
737423|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737424|NCT01662440|O4|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737425|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737426|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737427|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737428|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737429|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
745856|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
737431|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737432|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737433|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737434|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737435|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737436|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737437|NCT01662440|O3|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737438|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737439|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737440|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737441|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737442|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737443|NCT01662440|O3|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737444|NCT01662440|O2|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737445|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737446|NCT01662440|O2|Outcome|JE – Conv|Group Description Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737447|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737448|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737449|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737450|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737749|NCT01660802|P2|Participant Flow|Sham|Sham administered in the study eye on Day 1.
737451|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737452|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737453|NCT01662440|O1|Outcome|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737454|NCT01662440|O2|Outcome|JE – Conv|Subjects received JE vaccine, conventional schedule, ie, placebo on days 1, 4, 8 and 29 in the right arm or leg, and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737455|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737456|NCT01662440|O2|Outcome|R – Conv|Subjects received Rabies vaccine, conventional schedule, ie, Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg, and placebo on days 1, 8 and 29 in the left arm.
737457|NCT01662440|O1|Outcome|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, ie, Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg, and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
738018|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
737458|NCT01662440|E4|Reported Event|JE – Conv|Subjects received JE vaccine, conventional schedule, i.e. placebo on days 1, 4, 8 and 29 in the right arm or leg; and JE vaccination on days 1 and 29 and placebo injection on day 8 in the left arm.
737459|NCT01662440|E3|Reported Event|R – Conv|Subjects received Rabies vaccine, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and placebo on days 1, 8 and 29 in the left arm.
737460|NCT01662440|E2|Reported Event|R/JE – Acc|Subjects received Rabies and JE vaccines, accelerated schedule, i.e. Rabies vaccination on days 1, 4, and 8, and placebo on day 29 in the right arm or leg; and JE vaccination on days 1 and 8, and placebo on day 29 in the left arm.
737461|NCT01662440|E1|Reported Event|R/JE – Conv|Subjects received Rabies and JE vaccines, conventional schedule, i.e. Rabies vaccination on days 1, 8, and 29, and placebo on day 4 in the right arm or leg; and JE vaccination on day 1 and 29, and placebo on day 8 in the left arm.
737462|NCT01662362|B1|Baseline|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
737463|NCT01662362|P1|Participant Flow|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
737464|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|Test blood donor specimens that are ABBOTT PRISM Chagas Nonreactive with ESA Chagas. These specimens will be unidentified specimens from routine donor testing and not individually identifiable. Specimens that are positive or indeterminate with ESA Chagas will be further tested with RIPA.
737465|NCT01662362|O1|Outcome|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
737466|NCT01662362|E1|Reported Event|Testing Donor Specimens With ESA Chagas|"Test blood donor specimens that are ABBOTT PRISM Chagas Repeatedly Reactive with ESA Chagas. Donors will be asked to return for a follow-up blood draw.~Testing Donor Specimens with ESA Chagas: Donors will be asked to return for a follow-up blood draw."
737467|NCT01662310|B1|Baseline|Entire Study Population|All the participants who were enrolled.
737468|NCT01662310|P5|Participant Flow|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737469|NCT01662310|P4|Participant Flow|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737470|NCT01662310|P3|Participant Flow|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
737471|NCT01662310|P2|Participant Flow|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737472|NCT01662310|P1|Participant Flow|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 milligram per day (mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
737473|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737497|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737474|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737475|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737476|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737477|NCT01662310|O2|Outcome|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737624|NCT01661790|O1|Outcome|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
737478|NCT01662310|O1|Outcome|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737479|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
737480|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737481|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
737482|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737483|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
737484|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
737485|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737486|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
737487|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
737488|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737489|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
737490|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
737491|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737492|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
737493|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
737494|NCT01662310|O1|Outcome|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737495|NCT01662310|O1|Outcome|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
737496|NCT01662310|O2|Outcome|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study.
737750|NCT01660802|P1|Participant Flow|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
737498|NCT01662310|E5|Reported Event|Placebo DB/Paliperidone OL Extension Phase|Participants who transitioned from placebo treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737499|NCT01662310|E4|Reported Event|Paliperidone DB/Paliperidone Open-label (OL) Extension Phase|Participants who transitioned from paliperidone treatment group in DB phase (that is participants who experienced a relapse event during the DB phase or who remained relapse free for the entire duration of the double-blind phase and participants, who were enrolled at the time the study was terminated), entered open label extension phase, wherein paliperidone ER oral tablet was administered once daily as 3 to 12 mg.
737500|NCT01662310|E3|Reported Event|Placebo: DB Phase|Participants who transitioned from run-in or stabilization phase received matching placebo once daily during DB phase of the study.
737501|NCT01662310|E2|Reported Event|Paliperidone: Double Blind (DB) Phase|Participants who transitioned from run-in or stabilization phase received paliperidone at a starting dose of 3 mg up to 12 mg, fixed dose of paliperidone ER oral tablet once daily during DB phase of the study.
737502|NCT01662310|E1|Reported Event|Paliperidone: Run-in or Stabilization Phase|Paliperidone extended-release (ER) oral tablet was administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose was increased from 3 mg/day after 5 days based on Investigator's discretion, up to maximum of 12 mg/day.
737503|NCT01662102|B3|Baseline|Total|Total of all reporting groups
737504|NCT01662102|B2|Baseline|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m^2 of rituximab every 8 weeks for 24 months (12 infusions)"
737505|NCT01662102|B1|Baseline|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
737506|NCT01662102|P2|Participant Flow|Rituximab|"Patients will receive 375 mg/m^2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
737507|NCT01662102|P1|Participant Flow|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m^2); Day 7,8, or 9 rituximab (250 mg/m^2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
737508|NCT01662102|O2|Outcome|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
737509|NCT01662102|O1|Outcome|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
737510|NCT01662102|E2|Reported Event|Rituximab|"Patients will receive 375 mg/m2 of rituximab, administered by I.V. infusion every 8 weeks, starting 8 to 12 weeks after the last R-chemotherapy cycle.~Rituximab: Group B: Response maintenance with 375 mg/m2 of rituximab every 8 weeks for 24 months (12 infusions)"
737511|NCT01662102|E1|Reported Event|Zevalin and Rituximab|"90Y-Ibritumomab tiuxetan will be administered 8 to 12 weeks after the last chemotherapy infusion. Each patient randomized to this treatment group will receive a therapeutic dose of 14.8 MBq/kg (0.4 mCi/kg of total body weight) of 90Y ibritumomab tiuxetan (maximum 1,184 MBq or 32 mCi). Patients with a pre-treatment platelet count between 100 and 149 x109/L will receive 0.3 mCi/Kg 90Y-ibritumomab tiuxetan.The 90Y ibritumomab tiuxetan regimen is as follows: Day 1 rituximab (250 mg/m2); Day 7,8, or 9 rituximab (250 mg/m2) followed by 90Y ibritumomab tiuxetan within 4 hours of the end of the rituximab infusion.~Zevalin: Group A: Response consolidation with a single dose of 90Y-ibritumomab tiuxetan (Zevalin®) 0.4 mCi/Kg - Maximum dose: 32 mCi given with 2 doses of rituximab followed by observation for 24 months;"
737512|NCT01662063|B3|Baseline|Total|Total of all reporting groups
737513|NCT01662063|B2|Baseline|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737514|NCT01662063|B1|Baseline|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737751|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
737515|NCT01662063|P3|Participant Flow|Not Treated|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) were enrolled in this LTE study for an additional 96 weeks. Participants who met Screening criteria but did not receive treatment were excluded from analysis and reported in a separate arm.
737516|NCT01662063|P2|Participant Flow|SC TCZ Every Week (QW)|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737517|NCT01662063|P1|Participant Flow|Subcutaneous (SC) Tocilizumab (TCZ) Every 2 Weeks (Q2W)|Participants with moderate to severe rheumatoid arthritis (RA) who completed treatment with SC or intravenous (IV) TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this long-term extension (LTE) study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 milligrams (mg) Q2W.
737518|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737519|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737625|NCT01661790|E2|Reported Event|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
745857|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
737520|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737521|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737522|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737523|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737524|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737525|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737526|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737527|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737528|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737529|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737530|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737531|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737532|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737533|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737534|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737535|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737536|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737537|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737538|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737539|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737540|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
737541|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
737542|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
737543|NCT01662063|O1|Outcome|SC TCZ/All Participants|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW or SC TCZ 162 mg Q2W.
737544|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737545|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737546|NCT01662063|O1|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737547|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737548|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737549|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737550|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737752|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
737551|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737552|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737553|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737554|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737555|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737556|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737723|NCT01661114|P1|Participant Flow|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
737557|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737558|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737559|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737560|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737561|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737562|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737563|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737564|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737565|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737566|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737567|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737568|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737753|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
737754|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
737569|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737570|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737571|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737572|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737573|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737574|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737575|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737576|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737577|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737578|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737579|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737580|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737581|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737582|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737583|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737584|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737585|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737586|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737587|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737588|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737589|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737590|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737591|NCT01662063|O2|Outcome|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737592|NCT01662063|O1|Outcome|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
737593|NCT01662063|E2|Reported Event|SC TCZ QW|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received IV TCZ in the previous trial were switched to SC TCZ 162 mg QW, and those who received SC TCZ continued at their same dosage of SC TCZ 162 mg QW.
737594|NCT01662063|E1|Reported Event|SC TCZ Q2W|Participants with moderate to severe RA who completed treatment with SC or IV TCZ in one of the core studies WA22762 (NCT01194414) or NA25220 (NCT01232569) received treatment in this LTE study for an additional 96 weeks. Participants who received SC TCZ continued at their same dosage of SC TCZ 162 mg Q2W.
738019|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
737595|NCT01662024|B1|Baseline|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
737596|NCT01662024|P1|Participant Flow|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
737597|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
737598|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
737599|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
737600|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures"
737601|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
737602|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. D"
737603|NCT01662024|O1|Outcome|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures. Dietitian visits were performed at 1, 3, 6, 9, and 12 months to assess for the development of eating disorders. Clinical visits were performed at 1, 3, 6, and 12 months to obtain size and weight data. Perioperative adverse events were defined as those occurring during the procedure or the post-procedure observation period."
737604|NCT01662024|E1|Reported Event|Endoscopic Gastric Restrictive Procedure|"Restrict gastric size by approximating tissue endolumenally via an incisionless/per-oral approach.~Endoscopic gastric restrictive procedure: Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures."
737651|NCT01661270|B2|Baseline|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737755|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
737605|NCT01661933|B1|Baseline|Gluten Micro-challenge|Single arm, vertical. All twelve healthy adults enrolled subjects were successfully inoculated with hookworm and there was no serious adverse response. Individual hemoglobin levels were all normal and the group mean had significantly increased unexpectedly at completion of the study. Histology was not graded until after low-dose challenge but retrospectively confirmed enrollment Marsh scores of M0-8, M1-1, M2-2 and M3a-1. All participants were complying with a gluten-free diet, were symptomatically well and had a normal anti-tTG.
737606|NCT01661933|P1|Participant Flow|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
737607|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
737608|NCT01661933|O1|Outcome|Necator Americanus, Pre-gluten Challenge|Single arm, vertical. Ten of 12 participants enrolled based on symptomatic tolerance of gluten and satisfactory histology during and after micro-challenge. 2 were withdrawn pre-GC-1g, one who was symptomatically intolerant of gluten and one who had M3a after micro-challenge. Pre-GC1g scores.
737609|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, a detailed assessment including histology was performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
737724|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
737610|NCT01661933|O1|Outcome|Necator Americanus, Gluten Challenge|Single arm, vertical. Necator americanus: Subjects were inoculated with 20 3rd stage Na larvae (10 + 10 over 4-8 weeks). After hookworm colonization, a micro-dose gluten challenge of 10 mg daily for 6 weeks, followed by 50 mg daily for 6 weeks was completed. After this, assessments including histology were performed to establish it safe for the participant to proceed to a low-dose gluten challenge of 25 mg daily and 1 G (15-20 G of pasta) twice weekly for 12 weeks. After low-dose challenge, a further evaluation was undertaken before inviting participants to undertake a gluten challenge of 3 G daily over for 2 weeks (preceded by a micro-dose 2 week lead-in).
737611|NCT01661933|E1|Reported Event|Gluten Micro-challenge|Single arm, longitudinal study of responses to escalating gluten doses in people with celiac disease after infection with Necator americanus, a human hookworm.
737612|NCT01661881|B1|Baseline|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
737613|NCT01661881|P1|Participant Flow|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity."
737614|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
737652|NCT01661270|B1|Baseline|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737653|NCT01661270|P2|Participant Flow|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737615|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
737616|NCT01661881|O1|Outcome|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity. Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
737617|NCT01661881|E1|Reported Event|RB/RC|"Patients received 3 cycles of outpatient RB (rituximab 375 mg/m2 day 1, bendamustine 90 mg/m2 days 1 and 2 of a 4-week cycle), followed by interim CT restaging. Patients with progressive disease (PD) went off study. Those with stable disease (SD) or better went on to receive three cycles of inpatient RC (rituximab 375 mg/m2 day 1, cytarabine 3 g/m2 every 12 h for 4 doses). The cytarabine was dose reduced to:~2 g/m2 for age >60 years old, creatinine 114.9–176.8 lmol/l (for patients ≤60 years old), and pre-existing neurotoxicity;~1.5 g/m2 for age >60 years old AND creatinine 114.9–176.8 lmol/l, or for age >60 years old AND pre-existing neurotoxicity;~1 g/m2 for age > 60 years old AND creatinine 114.9–176.8 lmol/l AND pre-existing neurotoxicity.~Stem cell mobilization and collection, ASCT and post-transplantation supportive care were performed per institutional standard and not as part of this study."
737618|NCT01661790|B3|Baseline|Total|Total of all reporting groups
737619|NCT01661790|B2|Baseline|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
737620|NCT01661790|B1|Baseline|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
737621|NCT01661790|P2|Participant Flow|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
737622|NCT01661790|P1|Participant Flow|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,each 2 week"
737623|NCT01661790|O2|Outcome|Cisplatin|"Cisplatin 30mg by intrapleural given every two weeks~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
737725|NCT01661114|O1|Outcome|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
737626|NCT01661790|E1|Reported Event|Bevacizumab & Cisplatin|"Bevacizumab 300mg plus Cisplatin 30mg by intrapleural given every two weeks~Bevacizumab: Bevacizumab300mg&Cisplatin 30mg by intrapleural administration of each 2 week~Cisplatin: Cisplatin 30mg,intrapleural administration,Q2W"
737627|NCT01661621|B3|Baseline|Total|Total of all reporting groups
737628|NCT01661621|B2|Baseline|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737629|NCT01661621|B1|Baseline|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737630|NCT01661621|P2|Participant Flow|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737631|NCT01661621|P1|Participant Flow|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737632|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737633|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737634|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737635|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737636|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737637|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737638|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737639|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737640|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737641|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737642|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737643|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737644|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737645|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737646|NCT01661621|O2|Outcome|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737647|NCT01661621|O1|Outcome|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737648|NCT01661621|E2|Reported Event|Group 2|"α-blockers (Doxazosin 4 mg QD)~Doxazosin 4 mg QD: Group 2"
737649|NCT01661621|E1|Reported Event|Group 1|"Antimuscarinics (Detrusitol 4 mg QD)~Detrusitol 4 mg QD: Group 1"
737650|NCT01661270|B3|Baseline|Total|Total of all reporting groups
737742|NCT01660815|P1|Participant Flow|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
737743|NCT01660815|O2|Outcome|70-kg Model|Radiation dose estimate using a 70-kg model.
737654|NCT01661270|P1|Participant Flow|Placebo|Placebo for aflibercept intravenous (IV) infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737655|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737656|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737657|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737658|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737659|NCT01661270|O2|Outcome|Aflibercept|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737660|NCT01661270|O1|Outcome|Placebo|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737661|NCT01661270|E3|Reported Event|Mixed Administration (Placebo and Aflibercept)|Participants who were originally randomized to receive either Placebo or Aflibercept, actually received both the treatment (Placebo and Aflibercept).
737726|NCT01661114|E1|Reported Event|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
737662|NCT01661270|E2|Reported Event|Aflibercept Only|Aflibercept 4 mg/kg IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737663|NCT01661270|E1|Reported Event|Placebo Only|Placebo for IV infusion on Day 1 of each cycle (1 cycle = 2 weeks) in combination with FOLFIRI regimen until disease progression, unacceptable toxicity or participant's refusal. FOLFIRI regimen: Irinotecan 180 mg/m^2 IV infusion and leucovorin 400 mg/m^2 IV infusion, 5-Fluorouracil IV bolus 400 mg/m^2 followed by continuous IV infusion 2400 mg/m^2.
737664|NCT01661205|B1|Baseline|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737665|NCT01661205|P1|Participant Flow|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737666|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737667|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737668|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737669|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737670|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737671|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737672|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737744|NCT01660815|O1|Outcome|50-kg Model|Radiation dose estimate using a 50-kg model.
737673|NCT01661205|O1|Outcome|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737674|NCT01661205|E1|Reported Event|AtriCure Bipolar System Combined With a Catheter Ablation|"Minimally invasive procedure using the AtriCure Bipolar System plus a catheter ablation performed approximately 1-10 days apart~Ablation procedure staged catheter ablation: AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart"
737675|NCT01661179|B1|Baseline|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
737676|NCT01661179|P1|Participant Flow|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
737677|NCT01661179|O1|Outcome|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
737678|NCT01661179|E1|Reported Event|Vandetanib 300 mg|Vandetanib at 300 mg using 3 x 100 mg vandetanib tablets were dosed orally, once daily
737679|NCT01661140|B1|Baseline|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label MTX for 24 weeks.
737680|NCT01661140|P3|Participant Flow|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737681|NCT01661140|P2|Participant Flow|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737682|NCT01661140|P1|Participant Flow|Initial Phase|At Week 0 participants started open-label tocilizumab and open-label methotrexate (MTX) for 24 weeks, which was the initial phase of the study.
737766|NCT01660763|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
738020|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
737683|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737684|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737685|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737686|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737687|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737688|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737689|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737745|NCT01660815|E1|Reported Event|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
737690|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737691|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737692|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737693|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737694|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737695|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
745858|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
737696|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737697|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737698|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737699|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737700|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737701|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737702|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737703|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737704|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737705|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737706|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737707|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737708|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
745859|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
737709|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737710|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737711|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy..
737712|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737713|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737714|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737715|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737716|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737717|NCT01661140|O2|Outcome|Methotrexate (MTX) Maintenance Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737718|NCT01661140|O1|Outcome|Methotrexate (MTX) Tapering Group|After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.
737719|NCT01661140|E3|Reported Event|Methotrexate (MTX) Maintenance Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Maintenance Group participants continued to be administered the same dose of MTX in a double-blind fashion from Week 25 to Week 56. In addition, participants continued to receive open-label tocilizumab from Week 25 to Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
737720|NCT01661140|E2|Reported Event|Methotrexate (MTX) Tapering Group|"After the open-label period ended at Week 24, participants achieving a good/moderate European League Against Rheumatism (EULAR) disease response were randomized to the MTX Tapering Group or MTX Maintenance Group. In the MTX Tapering Group participants received a double-blind MTX dose according to the MTX tapering scheme between Week 24 and Week 56. In addition, participants continued to receive open-label tocilizumab between Week 24 and Week 56. From Week 56 to Week 72 participants received tocilizumab monotherapy.~Adverse events in this reporting group are those occurring in the double-blind phase only."
737721|NCT01661140|E1|Reported Event|Initial Phase|"At Week 0 participants will start open-label tocilizumab and open-label MTX for 24 weeks, which is the initial phase of the study.~Adverse events in this reporting group are those occurring in the open-label phase only."
737722|NCT01661114|B1|Baseline|Gemcitabine, 5-FU and Cisplatin|4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
737727|NCT01661062|B1|Baseline|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
737728|NCT01661062|P1|Participant Flow|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
737729|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
737730|NCT01661062|O1|Outcome|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
737731|NCT01661062|E1|Reported Event|Cone Beam CT|"For the purposes of this study patients will get CT scans every day for the length of their radiation therapy (in order to assess if CT every day provides additional information compared with CT scans performed less frequently).~Radiotherapy will be delivered according to current guidelines.~Imaging will be performed every day before treatment for a total of approximately 35 cone beam CT scans over the 7 week course of therapy."
737732|NCT01660906|B1|Baseline|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737733|NCT01660906|P1|Participant Flow|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737734|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737735|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737736|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737737|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737738|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737739|NCT01660906|O1|Outcome|Dasatinib (100 mg)|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737740|NCT01660906|E1|Reported Event|Dasatinib|Dasatinib: A 100 mg tablet was taken orally once a day for up to 12 months while on study.
737741|NCT01660815|B1|Baseline|Healthy Volunteers|"Cognitively normal, healthy volunteers at least 45 years of age.~florbetapir (18F) : IV injection, 370 MBq (10mCi), single dose"
737756|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
737757|NCT01660802|O2|Outcome|Sham|Sham administered in the study eye on Day 1.
737758|NCT01660802|O1|Outcome|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
737759|NCT01660802|E2|Reported Event|Sham|Sham administered in the study eye on Day 1.
737760|NCT01660802|E1|Reported Event|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
737761|NCT01660763|B3|Baseline|Total|Total of all reporting groups
737762|NCT01660763|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
737763|NCT01660763|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
737764|NCT01660763|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
737765|NCT01660763|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
737767|NCT01660763|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
737768|NCT01660763|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System/15 mcg : Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
737769|NCT01660763|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patients may elect to remain in study for up to 72 hours.
737770|NCT01660698|B3|Baseline|Total|Total of all reporting groups
737771|NCT01660698|B2|Baseline|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
737772|NCT01660698|B1|Baseline|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
737773|NCT01660698|P2|Participant Flow|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
737774|NCT01660698|P1|Participant Flow|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
737775|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
737776|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
737777|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
737778|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
737779|NCT01660698|O2|Outcome|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
737780|NCT01660698|O1|Outcome|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
737781|NCT01660698|E2|Reported Event|Probiotic|"probiotic blended in maltodextrin~Probiotic : probiotic blended in maltodextrin powder"
737782|NCT01660698|E1|Reported Event|Placebo|"maltodextrin powder~Maltodextrin : maltodextrin powder"
737783|NCT01660672|B1|Baseline|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
737784|NCT01660672|P1|Participant Flow|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
737785|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
737786|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
737787|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
737788|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted."
737789|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
737790|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
737791|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
737792|NCT01660672|O1|Outcome|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose."
737793|NCT01660672|E1|Reported Event|LEVETIRACETAM|"Open label, dose escalation to optimal dose.~LEVETIRACETAM: liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. This dose was effective in 7/7 children."
738066|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
737794|NCT01660334|B1|Baseline|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
737795|NCT01660334|P1|Participant Flow|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
737796|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
737797|NCT01660334|O1|Outcome|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
737798|NCT01660334|E1|Reported Event|Voriconazole for Scedosporium Disease|Participants taking Voriconazole for Scedosporium disease according to Japanese Package Insert.
737799|NCT01660321|B1|Baseline|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737800|NCT01660321|P1|Participant Flow|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737801|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737802|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737803|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737804|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737805|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737806|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
737807|NCT01660321|O1|Outcome|Natroba|Natroba (Spinosad) Topical Suspension, 0.9%
745860|NCT01627002|O9|Outcome|Part B Placebo|
737812|NCT01660230|B12|Baseline|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737813|NCT01660230|B11|Baseline|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737814|NCT01660230|B10|Baseline|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737815|NCT01660230|B9|Baseline|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737816|NCT01660230|B8|Baseline|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737817|NCT01660230|B7|Baseline|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737818|NCT01660230|B6|Baseline|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737819|NCT01660230|B5|Baseline|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737820|NCT01660230|B4|Baseline|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737821|NCT01660230|B3|Baseline|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737822|NCT01660230|B2|Baseline|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737823|NCT01660230|B1|Baseline|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737824|NCT01660230|P12|Participant Flow|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737825|NCT01660230|P11|Participant Flow|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737826|NCT01660230|P10|Participant Flow|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737827|NCT01660230|P9|Participant Flow|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737828|NCT01660230|P8|Participant Flow|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737829|NCT01660230|P7|Participant Flow|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737830|NCT01660230|P6|Participant Flow|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737831|NCT01660230|P5|Participant Flow|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737832|NCT01660230|P4|Participant Flow|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737833|NCT01660230|P3|Participant Flow|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737834|NCT01660230|P2|Participant Flow|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737835|NCT01660230|P1|Participant Flow|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737836|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
737837|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737838|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
738021|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
737839|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737840|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737841|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
737842|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737843|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737844|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737845|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737846|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
737847|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737848|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737849|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737850|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737851|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
737852|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737853|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737854|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737855|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737856|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
737857|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737858|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
738067|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
737859|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737860|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737861|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
737862|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737863|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737864|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737865|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
738022|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
737866|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737867|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737868|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737869|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737870|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737871|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737872|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737873|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737874|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737875|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737876|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737877|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737878|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737879|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737880|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737881|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737882|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737883|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737884|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737885|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738068|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
745169|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
737886|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737887|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737888|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737889|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737890|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737891|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737892|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737893|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738023|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
737894|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737895|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737896|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737897|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737898|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737899|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737900|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737901|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737902|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737903|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737904|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737905|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737906|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737907|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737908|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737909|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737910|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737911|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737912|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737913|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738069|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
737914|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737915|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737916|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737917|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737918|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737919|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737920|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737921|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738024|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
738025|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
737922|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737923|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737924|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737925|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737926|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737927|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737928|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737929|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737930|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737931|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737932|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737933|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737934|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737935|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737936|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737937|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737938|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737939|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737940|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738070|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
737941|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737942|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737943|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737944|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737945|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737946|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737947|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737948|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737949|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738026|NCT01660191|O2|Outcome|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
737950|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737951|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737952|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737953|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737954|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737955|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737956|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737957|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737958|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737959|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737960|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737961|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737962|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737963|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737964|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737965|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737966|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737967|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737968|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738071|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
737969|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737970|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737971|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737972|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737973|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737974|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737975|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737976|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737977|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737978|NCT01660230|O5|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 7-10: 0.9% sodium chloride in water and administered as 100 mL IV infusion over 15 minutes~0.9% NaCl in water"
737979|NCT01660230|O4|Outcome|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737980|NCT01660230|O3|Outcome|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737981|NCT01660230|O2|Outcome|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737982|NCT01660230|O1|Outcome|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737983|NCT01660230|O8|Outcome|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737984|NCT01660230|O7|Outcome|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737985|NCT01660230|O6|Outcome|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737986|NCT01660230|O5|Outcome|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737987|NCT01660230|O4|Outcome|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737988|NCT01660230|O3|Outcome|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737989|NCT01660230|O2|Outcome|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737990|NCT01660230|O1|Outcome|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737991|NCT01660230|E12|Reported Event|Matching Placebo, 0.9% NaCl in Water|"Cohorts 1-10: 0.9% sodium chloride in water and administered as either 20 mL IV infusion over 15 minutes (Cohort 1), or 100 mL IV infusion over 15 minutes (Cohorts 2-10)~0.9% NaCl in water"
737992|NCT01660230|E11|Reported Event|540 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 10: 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737993|NCT01660230|E10|Reported Event|360 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 9: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737994|NCT01660230|E9|Reported Event|180 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 8: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
737995|NCT01660230|E8|Reported Event|90 µg/kg 3K3A-APC, q12h for 5 Doses|"Cohort 7: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes; given every 12 hours for 5 doses~3K3A-APC, diluted in 0.9% sodium chloride in water"
738072|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
738073|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
737996|NCT01660230|E7|Reported Event|540 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 540 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737997|NCT01660230|E6|Reported Event|720 µg/kg 3K3A-APC, Single-dose|"Cohort 6: TBD (not to exceed 720) 720 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737998|NCT01660230|E5|Reported Event|360 µg/kg 3K3A-APC, Single-dose|"Cohort 5: 360 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
737999|NCT01660230|E4|Reported Event|180 µg/kg 3K3A-APC, Single-dose|"Cohort 4: 180 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738000|NCT01660230|E3|Reported Event|90 µg/kg 3K3A-APC, Single-dose|"Cohort 3: 90 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738001|NCT01660230|E2|Reported Event|30 µg/kg 3K3A-APC, Single-dose|"Cohort 2: 30 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 100 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738002|NCT01660230|E1|Reported Event|6 µg/kg 3K3A-APC, Single-dose|"Cohort 1: 6 µg/kg 3K3A-APC, diluted in 0.9% sodium chloride in water and administered as an 20 mL IV infusion over 15 minutes~3K3A-APC, diluted in 0.9% sodium chloride in water"
738003|NCT01660191|B4|Baseline|Total|Total of all reporting groups
738004|NCT01660191|B3|Baseline|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
738005|NCT01660191|B2|Baseline|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
738006|NCT01660191|B1|Baseline|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
738007|NCT01660191|P3|Participant Flow|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
738008|NCT01660191|P2|Participant Flow|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
738009|NCT01660191|P1|Participant Flow|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
738010|NCT01660191|O3|Outcome|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
738027|NCT01660191|O1|Outcome|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
738028|NCT01660191|E3|Reported Event|Rosuvastatin 5 mg|Rosuvastatin 5mg, once daily by mouth for 12 weeks
738029|NCT01660191|E2|Reported Event|Pitavastatin 4mg|Pitavastatin 4mg, once daily by mouth for 12 weeks
738030|NCT01660191|E1|Reported Event|Atorvastatin 20mg|Atorvastatin 20mg, once daily by mouth for 12 weeks
738031|NCT01660022|B7|Baseline|Total|Total of all reporting groups
738032|NCT01660022|B6|Baseline|Placebo|Cohorts 1, 2, 3, 4 and 5
738033|NCT01660022|B5|Baseline|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800 mg / PQP 1440 mg
738034|NCT01660022|B4|Baseline|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300 mg / PQP 1440 mg
738035|NCT01660022|B3|Baseline|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 1440 mg
738036|NCT01660022|B2|Baseline|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 480 mg
738037|NCT01660022|B1|Baseline|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100 mg / PQP 160 mg
738038|NCT01660022|P6|Participant Flow|Placebo|Cohorts 1, 2, 3, 4 and 5
738039|NCT01660022|P5|Participant Flow|Cohort 5|Sequence 1: OZ439 800mg Sequence 2: OZ439 800mg+PQP 1440mg
738040|NCT01660022|P4|Participant Flow|Cohort 4|Sequence 1: OZ439 300mg Sequence 2: OZ439 300mg+PQP 1440mg
738041|NCT01660022|P3|Participant Flow|Cohort 3|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 1440mg
738042|NCT01660022|P2|Participant Flow|Cohort 2|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg+PQP 480mg
738043|NCT01660022|P1|Participant Flow|Cohort 1|Sequence 1: OZ439 100mg Sequence 2: OZ439 100mg / PQP 160mg
738044|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
738045|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
738046|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
738047|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
738048|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
738049|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
738050|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
738051|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
738052|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
738053|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
738054|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
738055|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
738056|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
738057|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
738058|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
738059|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
738060|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
738061|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
738062|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
738063|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
738064|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
738065|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
745480|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
738074|NCT01660022|O5|Outcome|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
738075|NCT01660022|O4|Outcome|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
738076|NCT01660022|O3|Outcome|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
738077|NCT01660022|O2|Outcome|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
738078|NCT01660022|O1|Outcome|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
738079|NCT01660022|O10|Outcome|Cohort 5 - OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
738080|NCT01660022|O9|Outcome|Cohort 5 - OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
738081|NCT01660022|O8|Outcome|Cohort 4 - OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
738082|NCT01660022|O7|Outcome|Cohort 4 - OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
738083|NCT01660022|O6|Outcome|Cohort 3 - OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
738084|NCT01660022|O5|Outcome|Cohort 3 - OZ439 100mg|Cohort 3 - Sequence 1 OZ439 100mg
738085|NCT01660022|O4|Outcome|Cohort 2 - OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
738086|NCT01660022|O3|Outcome|Cohort 2 - OZ439 100mg|Cohort 2 - Sequence 1 OZ439 100mg
738087|NCT01660022|O2|Outcome|Cohort 1 - OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
738088|NCT01660022|O1|Outcome|Cohort 1 - OZ439 100mg|Cohort 1 - Sequence 1 OZ439 100mg
738089|NCT01660022|E9|Reported Event|Placebo|Cohorts 1, 2, 3, 4 and 5
745861|NCT01627002|O8|Outcome|Part B PA401 3.0 mg|
738090|NCT01660022|E8|Reported Event|OZ439 800mg / PQP 1440mg|Cohort 5 - Sequence 2 OZ439 800mg / PQP 1440mg
738091|NCT01660022|E7|Reported Event|OZ439 300mg / PQP 1440mg|Cohort 4 - Sequence 2 OZ439 300mg / PQP 1440mg
738092|NCT01660022|E6|Reported Event|OZ439 100mg / PQP 1440mg|Cohort 3 - Sequence 2 OZ439 100mg / PQP 1440mg
738093|NCT01660022|E5|Reported Event|OZ439 100mg / PQP 480mg|Cohort 2 - Sequence 2 OZ439 100mg / PQP 480mg
738094|NCT01660022|E4|Reported Event|OZ439 100mg / PQP 160mg|Cohort 1 - Sequence 2 OZ439 100mg / PQP 160mg
738095|NCT01660022|E3|Reported Event|OZ439 800mg|Cohort 5 - Sequence 1 OZ439 800mg
738096|NCT01660022|E2|Reported Event|OZ439 300mg|Cohort 4 - Sequence 1 OZ439 300mg
738097|NCT01660022|E1|Reported Event|OZ439 100mg|Cohorts 1, 2 and 3 OZ439 100mg
738098|NCT01659996|B4|Baseline|Total|Total of all reporting groups
738099|NCT01659996|B3|Baseline|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
738100|NCT01659996|B2|Baseline|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
738101|NCT01659996|B1|Baseline|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738102|NCT01659996|P3|Participant Flow|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
738103|NCT01659996|P2|Participant Flow|Menactra + Pentacel Vaccine Group|All participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738104|NCT01659996|P1|Participant Flow|Menactra Vaccine Group|All participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738105|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
738106|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738107|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738108|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
738109|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738110|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
738111|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
738112|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738113|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738114|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
738115|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738116|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738117|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
738118|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738119|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
738120|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age.
738121|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738378|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
738122|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
738123|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
738124|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738125|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738126|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
738127|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738128|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738129|NCT01659996|O3|Outcome|Pentacel Vaccine Group|Study participants that received only Pentacel vaccine at 15 to 18 months of age
738130|NCT01659996|O2|Outcome|Menactra + Pentacel Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months.
738131|NCT01659996|O1|Outcome|Menactra Vaccine Group|Study participants that received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months.
738132|NCT01659996|E3|Reported Event|Pentacel Vaccine Group|Study participants received only Pentacel vaccine at 15 to 18 months of age
738133|NCT01659996|E2|Reported Event|Menactra + Pentacel Vaccine Group|Study participants received Menactra vaccine at 9 months of age and Menactra vaccine and Pentacel vaccine concomitantly at age 15 to 18 months
738134|NCT01659996|E1|Reported Event|Menactra Vaccine Group|Study participants received Menactra vaccine at 9 months of age and a second dose of Menactra vaccine at age 15 to 18 months
738135|NCT01659853|B1|Baseline|Overall Study|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
738136|NCT01659853|P2|Participant Flow|Azelaic Acid Gel 15%, Then CD07805/47 Gel 0.5% and Vehicle|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
738137|NCT01659853|P1|Participant Flow|CD07805/47 Gel 0.5% and Vehicle, Then Azelaic Acid Gel 15%|"Subjects were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) will switch to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
738138|NCT01659853|O2|Outcome|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
738139|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
738140|NCT01659853|O2|Outcome|Azelaic Acid Gel 15%|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
738141|NCT01659853|O1|Outcome|CD07805/47 Gel 0.5% and Vehicle|"Participants were randomly assigned to treatment sequence. Thirty-five subjects received CD07805/47 gel 0.5% and 35 received azelaic acid gel in Period 1.~A carryover effect was observed from Period 1 to Period 2. Therefore, as specified in the protocol, only the Period 1 results were analyzed."
738142|NCT01659853|E2|Reported Event|Azelaic Acid 15%|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
738143|NCT01659853|E1|Reported Event|CD07805/47 Gel 0.5 and Vehicle|"Participants were randomly assigned to treatment sequence.~Subjects who received CD07805/47 gel 0.5% and CD07805/47 gel vehicle during Period 1 (baseline to Day 15) switched to azelaic acid gel in Period 2.~Subjects who received azelaic acid gel 15% during Period 1 (baseline to Day 15) switched to CD07805/47 gel 0.5% and CD07805/47 gel vehicle in Period 2.~Subjects assigned to brimonidine tartrate gel 0.5% applied it once daily in the morning and applied brimonidine tartrate gel vehicle once daily in the evening. Subjects assigned to azelaic acid gel 15% applied it twice daily according to FDA approved prescribing information."
738144|NCT01659736|B3|Baseline|Total|Total of all reporting groups
745481|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
738145|NCT01659736|B2|Baseline|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738146|NCT01659736|B1|Baseline|TMS Therapy|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738147|NCT01659736|P2|Participant Flow|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738148|NCT01659736|P1|Participant Flow|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738149|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738150|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738151|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738152|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738153|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
745862|NCT01627002|O7|Outcome|Part B PA401 1.0 mg|
738154|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738155|NCT01659736|O2|Outcome|TMS- Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738156|NCT01659736|O1|Outcome|TMS- Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738157|NCT01659736|O2|Outcome|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738158|NCT01659736|O1|Outcome|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738159|NCT01659736|E2|Reported Event|TMS-Sham|"This is a sham TMS condition~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738160|NCT01659736|E1|Reported Event|TMS-Treatment|"TMS treatment~TMS: Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.~Treatment in the substudy will entail 2 days/week sessions of TMS for 5 weeks."
738161|NCT01659554|B1|Baseline|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
738162|NCT01659554|P1|Participant Flow|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
738163|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
738164|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
738165|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
738166|NCT01659554|O1|Outcome|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
738167|NCT01659554|E1|Reported Event|Intraoperative Cisplatin Followed by IP Chemotherapy|"Intraoperative (hyperthermic) cisplatin followed by 4 courses of intraperitoneal cisplatin and doxorubicin given on days 1 & 8 during a 3 week cycle~Intraoperative (hyperthermic) cisplatin followed by IP Cisplatin; Doxorubicin: Cisplatin 75 mg/m2 at 40.5-42.5 Celsius intraoperatively administered; IP Cisplatin 75 mg/m2 (Day 1) week 1 followed by IP Doxorubicin 25 mg week 2 (day 8) for four sequential 3 week cycles;"
738168|NCT01659320|B1|Baseline|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
738695|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738169|NCT01659320|P1|Participant Flow|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
738170|NCT01659320|O1|Outcome|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
738171|NCT01659320|E1|Reported Event|Minocycline|"Open label treatment using minocycline.~Minocycline: Minocycline 100 mg twice daily for 8 weeks"
738172|NCT01659268|B3|Baseline|Total|Total of all reporting groups
738173|NCT01659268|B2|Baseline|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
738174|NCT01659268|B1|Baseline|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
738175|NCT01659268|P2|Participant Flow|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
738176|NCT01659268|P1|Participant Flow|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
738341|NCT01658514|B3|Baseline|Moderate RI|Moderate Renal Impairment = eGFR ≥30 to <60 mL/min/1.73 m²
745863|NCT01627002|O6|Outcome|Part A Placebo|
738177|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
738178|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
738179|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
738180|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
738181|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
738182|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
738183|NCT01659268|O2|Outcome|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
738184|NCT01659268|O1|Outcome|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
738185|NCT01659268|E2|Reported Event|Control|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to the and practical activity in skill lab using the low-fidelity mannequin.~Each subgroup will be composed of 4-5 students for the practice activity which will last 35 minutes."
738186|NCT01659268|E1|Reported Event|Simulation Class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
738187|NCT01659125|B1|Baseline|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
738188|NCT01659125|P1|Participant Flow|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
738189|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
738190|NCT01659125|O1|Outcome|OCFighter Participants|Participants who initiated treatment
738225|NCT01658943|E1|Reported Event|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738226|NCT01658904|B4|Baseline|Total|Total of all reporting groups
738191|NCT01659125|E1|Reported Event|OCFighter Participants|"OCFighter~OCFighter: OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP)."
738192|NCT01659021|B3|Baseline|Total|Total of all reporting groups
738193|NCT01659021|B2|Baseline|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738194|NCT01659021|B1|Baseline|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738195|NCT01659021|P2|Participant Flow|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738209|NCT01659021|E2|Reported Event|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738196|NCT01659021|P1|Participant Flow|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of chronic lymphocytic leukemia (CLL), intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738197|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738198|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738199|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Participants in this group had 17p deletion and/or TP53 mutation."
738200|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation~Participants in this group had 17p deletion and/or TP53 mutation."
738201|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738202|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738203|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738277|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738379|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
738204|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738205|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738206|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738207|NCT01659021|O2|Outcome|Ofatumumab|"Randomized Initial Therapy (24 weeks): Ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 2000 mg weekly for 7 weeks, and then 2000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Observation until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738208|NCT01659021|O1|Outcome|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738262|NCT01658813|O1|Outcome|Number of Responders|the number of patients responding
738263|NCT01658813|O1|Outcome|Progression Free Survival|5-Fluorouracil and Interferon-alfa-2b
738264|NCT01658813|E1|Reported Event|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
738210|NCT01659021|E1|Reported Event|Idelalisib+Ofatumumab|"Randomized Initial Therapy (24 weeks): Idelalisib 150 mg tablets twice daily + ofatumumab for a total of 12 infusions (300 mg on Day 1, followed by 1000 mg weekly for 7 weeks, and then 1000 mg every 4 weeks for 4 doses)~Continuing Therapy/Observation: Idelalisib 150 mg tablets twice daily until the earliest of subject withdrawal from study, definitive progression of CLL, intolerable idelalisib-related toxicity, pregnancy or initiation of breast feeding, substantial noncompliance with study procedures, or study discontinuation"
738211|NCT01658943|B3|Baseline|Total|Total of all reporting groups
738212|NCT01658943|B2|Baseline|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738213|NCT01658943|B1|Baseline|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738214|NCT01658943|P2|Participant Flow|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738215|NCT01658943|P1|Participant Flow|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738216|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738217|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738218|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738219|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738220|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738221|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738222|NCT01658943|O2|Outcome|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738223|NCT01658943|O1|Outcome|mFOLFOX|Patients receive 85 mg/m^2 oxaliplatin IV over 2 hours on days 1 and 15 and 2,400 mg/m^2 fluorouracil IV over 46-48 hours on days 1-2 and 15-16. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738224|NCT01658943|E2|Reported Event|MK2206 and Selumetinib|Patients receive 135 mg MK2206 PO on days 1, 8, 15, and 22, and 100 mg selumetinib PO daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
738380|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
745482|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
738227|NCT01658904|B3|Baseline|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738228|NCT01658904|B2|Baseline|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738229|NCT01658904|B1|Baseline|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738230|NCT01658904|P3|Participant Flow|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738265|NCT01658735|B4|Baseline|Total|Total of all reporting groups
738231|NCT01658904|P2|Participant Flow|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738232|NCT01658904|P1|Participant Flow|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738233|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738234|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738235|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738236|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
738278|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738328|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738237|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
738238|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70.~Carfilzomib~Melphalan~Filgrastim"
738239|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738240|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738266|NCT01658735|B3|Baseline|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738286|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738241|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738242|NCT01658904|O3|Outcome|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738243|NCT01658904|O2|Outcome|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738244|NCT01658904|O1|Outcome|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738245|NCT01658904|E3|Reported Event|Cohort 3-CFZ 20 mg/m^2 (Day1,2,8,9/AHCT)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738246|NCT01658904|E2|Reported Event|Cohort 2- CFZ 20 mg/m^2 (Day 1,2,8,9)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738247|NCT01658904|E1|Reported Event|Cohort 1- CFZ 20 mg/m^2 (Day 1,2)|"Phase I/II study on the backbone of high-dose melphalan on day -2 pre-autologous hematopoietic cell transplantation (AHCT)~•Addition of an increasing number of doses of Carfilzomib (CFZ) in the early post-AHCT period introduced in a step-wise fashion in 3 successive cohorts of 3 to 15 subjects:~Cohort 1: add CFZ 20 mg/m^2 intravenous (IV) on days +1, +2~Cohort 2 : add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9~Cohort 3: add CFZ 20 mg/m^2 IV on days: +1, +2, +8, +9 and add an early post-AHCT consolidation following engraftment: CFZ 20 mg/m^2 IV given on days 42-43 then CFZ 56 mg/m^2 IV given on days 49-50, 56-57, then on days 70."
738248|NCT01658839|B1|Baseline|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738249|NCT01658839|P1|Participant Flow|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738250|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738251|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738252|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738253|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738254|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738255|NCT01658839|O1|Outcome|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738256|NCT01658839|E1|Reported Event|Travoprost|Travoprost ophthalmic solution, 0.004% (new formulation), one drop administered topically in the inferior cul-de-sac of the eye each morning at 9 AM (± 60 minutes) for 7 days
738257|NCT01658813|B1|Baseline|Number of Participants|5-Fluorouracil and Interferon-alfa-2b
738258|NCT01658813|P1|Participant Flow|5-FU and Interferon-alfa-2b|All patients received 5-Fluorouracil and Interferon-alfa-2b
738259|NCT01658813|O1|Outcome|Median Survival|The median survival of patients treated on study was determined.
738260|NCT01658813|O1|Outcome|Median Duration of Response|The median duration of response was determined.
738261|NCT01658813|O1|Outcome|Response Rate|percentage of patients responding
738267|NCT01658735|B2|Baseline|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738268|NCT01658735|B1|Baseline|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738269|NCT01658735|P3|Participant Flow|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738270|NCT01658735|P2|Participant Flow|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738271|NCT01658735|P1|Participant Flow|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738272|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738273|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738274|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738275|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738276|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738279|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738280|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738281|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738282|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738283|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738284|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738285|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738287|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738288|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738289|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738290|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738291|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738292|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738293|NCT01658735|O3|Outcome|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738294|NCT01658735|O2|Outcome|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738295|NCT01658735|O1|Outcome|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738296|NCT01658735|E3|Reported Event|Sham Electrotherapy|"Sham Device plus Usual Care.~Sham: The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical."
738297|NCT01658735|E2|Reported Event|TENS|"Transcutaneous electrical nerve stimulation (TENS) Device with Usual Care~Transcutaneous Electrical Nerve Stimulation (TENS): Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding."
738298|NCT01658735|E1|Reported Event|H-Wave Device|"H-Wave Device with Usual Care~H-Wave: Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect."
738300|NCT01658657|B2|Baseline|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
738301|NCT01658657|B1|Baseline|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
738302|NCT01658657|P2|Participant Flow|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
738303|NCT01658657|P1|Participant Flow|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
738304|NCT01658657|O2|Outcome|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
738305|NCT01658657|O1|Outcome|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
738306|NCT01658657|E2|Reported Event|Fixed-dose Combination Treatment-guided Therapy|"Participants randomized to the fixed-dose combination treatment-guided arm will be prescribed standard anti-hypertensive medications without regard to renin activity level.~Amlodipine~metoprolol~lisinopril/hydrochlorothiazide"
738307|NCT01658657|E1|Reported Event|PRA-guided Therapy|"Participants randomized to the PRA-guided therapy treatment arm will be prescribed anti-hypertensive medications based on renin activity level as defined at baseline.~Hydrochlorothiazide~Lisinopril~Amlodipine~metoprolol"
738308|NCT01658579|B5|Baseline|Total|Total of all reporting groups
738309|NCT01658579|B4|Baseline|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
745864|NCT01627002|O5|Outcome|Part A PA401 10 mg|
738310|NCT01658579|B3|Baseline|Lantus Morning Then Evening|Lantus SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
738311|NCT01658579|B2|Baseline|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B.
738312|NCT01658579|B1|Baseline|HOE901-U300 Morning Then Evening|HOE901-U300 SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B.
738313|NCT01658579|P4|Participant Flow|Lantus Evening Then Morning|Lantus SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
738314|NCT01658579|P3|Participant Flow|Lantus Morning Then Evening|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
738315|NCT01658579|P2|Participant Flow|HOE901-U300 Evening Then Morning|HOE901-U300 SC injection once daily in evening for 8 weeks during treatment period A, followed by once daily in morning for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 mmol/L (80–130 mg/dL).
738316|NCT01658579|P1|Participant Flow|HOE901-U300 Morning Then Evening|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily in morning for 8 weeks during treatment period A, followed by once daily in evening for 8 weeks during treatment period B. Dose titration seeking fasting plasma glucose 4.4-7.2 millimole per liter (mmol/L) (80–130 milligram per deciliter [mg/dL]).
738317|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738318|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738319|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738320|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738321|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738322|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738323|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738324|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738325|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738326|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738327|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738329|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738330|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738331|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738332|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738333|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738334|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738335|NCT01658579|O2|Outcome|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738336|NCT01658579|O1|Outcome|HOE901-U300 Combined|HOE901-U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738337|NCT01658579|E2|Reported Event|Lantus Combined|Lantus SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738338|NCT01658579|E1|Reported Event|HOE901-U300 Combined|HOE901­U300 SC injection once daily in morning or evening for 8 weeks during treatment period A, followed by once daily in evening or morning for 8 weeks during treatment period B.
738339|NCT01658514|B5|Baseline|Total|Total of all reporting groups
738340|NCT01658514|B4|Baseline|Severe RI|Severe Renal Impairment = eGFR ≥15 to <30 mL/min/1.73 m²
738342|NCT01658514|B2|Baseline|Mild RI|Mild Renal Impairment = eGFR ≥60 to <90 mL/min/1.73 m²
738343|NCT01658514|B1|Baseline|Normal|Normal Renal Function = eGFR ≥90 mL/min/1.73 m²
738344|NCT01658514|P3|Participant Flow|Sequence BCA|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
738345|NCT01658514|P2|Participant Flow|Sequence CAB|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
738346|NCT01658514|P1|Participant Flow|Sequence ABC|"A = 1 dose of 1000 mg Met XR B = 1 dose of 1000 mg Met DR C = 1 dose of placebo~each treatment was separated by a wash out period of 2 to 10 days"
738347|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
738348|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
738349|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
738350|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
738351|NCT01658514|O2|Outcome|Met XR|One dose of 1000 mg Metformin Extended-Release
738352|NCT01658514|O1|Outcome|Met DR|One dose of 1000 mg Metformin Delayed-Release
738353|NCT01658514|E3|Reported Event|Met XR|One dose of 1000 mg Metformin Extended-Release
738354|NCT01658514|E2|Reported Event|Met DR|One dose of 1000 mg Metformin Delayed-Release
738355|NCT01658514|E1|Reported Event|Placebo|One dose of Placebo
738356|NCT01658436|B1|Baseline|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
738357|NCT01658436|P2|Participant Flow|BEZ235 400 mg Bid|Oral BEZ235 400 mg bid was investigated in stage 1 of study
738358|NCT01658436|P1|Participant Flow|BEZ235 300 mg|Oral BEZ235 300 mg bid was investigated in stage 1 of study
738359|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
738360|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
738361|NCT01658436|O1|Outcome|BEZ235 300 mg/400 mg Bid|Oral BEZ235 300 mg/400 mg bid was investigated in stage 1 of study
738362|NCT01658436|E2|Reported Event|BEZ235 400 mg Bid|BEZ235 400 mg bid
738363|NCT01658436|E1|Reported Event|BEZ235 300 mg Bid|BEZ235 300 mg bid
738364|NCT01658072|B3|Baseline|Total|Total of all reporting groups
738365|NCT01658072|B2|Baseline|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
738366|NCT01658072|B1|Baseline|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
738367|NCT01658072|P2|Participant Flow|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
738368|NCT01658072|P1|Participant Flow|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
738369|NCT01658072|O2|Outcome|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
738370|NCT01658072|O1|Outcome|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
738371|NCT01658072|E2|Reported Event|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural Patient Controlled Analgesia (Epidural PCA): Epidural analgesia pathway.
738372|NCT01658072|E1|Reported Event|Peri-Articular Injection|Peri-Articular Injection: Use of a different analgesic protocol, based on a peri-articular injection
738373|NCT01658020|B3|Baseline|Total|Total of all reporting groups
738374|NCT01658020|B2|Baseline|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
738375|NCT01658020|B1|Baseline|DW224|Zabofloxacin 367mg tablet P.O. once daily for 3 days and then placebo P.O. once daily for 2 days
738376|NCT01658020|P2|Participant Flow|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7days
738377|NCT01658020|P1|Participant Flow|DW224|Zabofloxacin 400mg tablet P.O. once daily for 5days and Placebo P.O. once daily
738381|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
738382|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
738383|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
738384|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
738385|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
738386|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily 7 days
738387|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
738388|NCT01658020|O2|Outcome|Avelox|Moxifloxacin 400mg tablet P.O. once daily for 7 days
738389|NCT01658020|O1|Outcome|DW224|Zabofloxacin 367mg tablet P.O. once daily for 5 days and then placebo P.O. once daily for 2 days
738390|NCT01658020|E2|Reported Event|Avelox|"Moxifloxacin Tablet 400mg given by oral administration~Zabofloxacin Tablet 400mg: multiple-dose"
738391|NCT01658020|E1|Reported Event|DW224|"Zabofloxacin Tablet 400mg given by oral administration~Moxifloxacin Tablet 400mg: multiple-dose"
738392|NCT01657903|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline parameters.
738423|NCT01657877|O3|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738424|NCT01657877|O2|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 0 ppm fluoride and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738393|NCT01657903|P1|Participant Flow|Overall|This was a 4-way crossover study. Participants brushed with 1.5 g of low relative dentine abrasivity (RDA) gel to foam toothpaste (Toothpaste 1) containing 1450 parts per million (ppm) of fluoride (F) as sodium fluoride (NaF) and 5% weight by weight (w/w) potassium nitrate (KNO3); 1.5 g of medium RDA gel to foam toothpaste (Toothpaste 2) containing 1450 ppm F as NaF and 5% w/w KNO3; 1.5 g of Marketed toothpaste (Toothpaste 3) containing 1450 ppm F as NaF and 5% w/w KNO3; and 1.5 g of placebo toothpaste containing no fluoride but 5% w/w KNO3. There was a washout period of 2 days following each treatment session. In this washout period, participants used a non-fluoridated toothpaste to ensure no carry over effect.
738394|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
738395|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738396|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738397|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738398|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
738399|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738400|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738401|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738402|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppm F) containing only 5% w/w KNO3.
738403|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738404|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738405|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738406|NCT01657903|O4|Outcome|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
738407|NCT01657903|O3|Outcome|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738408|NCT01657903|O2|Outcome|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738409|NCT01657903|O1|Outcome|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738410|NCT01657903|E4|Reported Event|No Fluoride/KNO3 Toothpaste|Participants brushed with a fluoride free toothpaste (0 ppmF) containing only 5% w/w KNO3.
738411|NCT01657903|E3|Reported Event|NaF/KNO3 Toothpaste 3|Participants brushed with 1.5 g of NaF/KNO3 toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738412|NCT01657903|E2|Reported Event|NaF/KNO3 Toothpaste 2|Participants brushed with 1.5 g of medium RDA gel to foam toothpaste containing 1450 ppm F as NaF and 5% w/w KNO3.
738413|NCT01657903|E1|Reported Event|NaF/KNO3 Toothpaste 1|Participants brushed with 1.5 g of low RDA gel to foam toothpaste containing 1450 parts per million of fluoride as NaF and 5% w/w KNO3.
738414|NCT01657877|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline characteristics.
738415|NCT01657877|P1|Participant Flow|Overall Participants|"In this cross-over study, participant partial dentures were modified to hold two enamel specimens. Denture was modified at the start of the first treatment period to hold the enamel specimens. The participants were randomized using a computer generated program to receive following dentifrices:~Dentifrice containing 1500 parts per million (ppm) as sodium monofluorophosphate (SMFP) + 5% calcium sodium phosphosilicate (CSP)~Dentifrice containing 1500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 500 ppm fluoride as SMFP + 0% CSP~Dentifrice containing 0 ppm fluoride + 0% CSP~Dentifrice containing 0 ppm fluoride + 5% CSP. The participants applied the given dentifrice as per their treatment group to a toothbrush and brushed their natural teeth twice daily for one timed minute. There was a washout period of 6 days between each treatment period."
738416|NCT01657877|O2|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738417|NCT01657877|O1|Outcome|Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738418|NCT01657877|O5|Outcome|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738419|NCT01657877|O4|Outcome|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738420|NCT01657877|O3|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738421|NCT01657877|O2|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738422|NCT01657877|O1|Outcome|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738856|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738425|NCT01657877|O1|Outcome|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738426|NCT01657877|E5|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738427|NCT01657877|E4|Reported Event|Dentifrice Containing 0 Ppm Fluoride + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing no fluoride and no CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738428|NCT01657877|E3|Reported Event|Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738429|NCT01657877|E2|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 0 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738430|NCT01657877|E1|Reported Event|Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP|Participants applied a full ribbon of the dentifrice (approximately 1.5 g) containing 1500 ppm fluoride as SMFP and 5 % CSP, to a toothbrush and brushed their natural teeth twice daily for one timed minute.
738431|NCT01657461|B3|Baseline|Total|Total of all reporting groups
738432|NCT01657461|B2|Baseline|IV t-PA|IV infusion of tPA
738433|NCT01657461|B1|Baseline|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738434|NCT01657461|P2|Participant Flow|IV t-PA|IV infusion of tPA
738435|NCT01657461|P1|Participant Flow|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738436|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738437|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738438|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738439|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738440|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738441|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738442|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738443|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738444|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738445|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738446|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738447|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738448|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738449|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738450|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738451|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738452|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738453|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738454|NCT01657461|O2|Outcome|IV t-PA|IV infusion of tPA
738455|NCT01657461|O1|Outcome|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738456|NCT01657461|E2|Reported Event|IV t-PA|IV infusion of tPA
738457|NCT01657461|E1|Reported Event|IV t-PA With Solitaire™ Revascularization Device|Dual IV tPA therapy and adjunctive treatment with the Solitaire™ FR
738458|NCT01657370|B7|Baseline|Total|Total of all reporting groups
738635|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738459|NCT01657370|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738460|NCT01657370|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738461|NCT01657370|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738462|NCT01657370|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738463|NCT01657370|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738464|NCT01657370|B1|Baseline|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738465|NCT01657370|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738466|NCT01657370|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738467|NCT01657370|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738468|NCT01657370|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738469|NCT01657370|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738470|NCT01657370|P1|Participant Flow|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738471|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738472|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738473|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738474|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738475|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738476|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738477|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738478|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738479|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738480|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738481|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738482|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738483|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738484|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738485|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738486|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738487|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738488|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738489|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738490|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738491|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738492|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
745865|NCT01627002|O4|Outcome|Part A PA401 3.0 mg|
738493|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738494|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738495|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738496|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738497|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738498|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738499|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738500|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738501|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738502|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738503|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738504|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738505|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738506|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738507|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738508|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738509|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738510|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738511|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738512|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738513|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738514|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738515|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738516|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738517|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738518|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
745866|NCT01627002|O3|Outcome|Part A PA401 1.0 mg|
738519|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738520|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738521|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738522|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738523|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738524|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738525|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738526|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738527|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738528|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738529|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738530|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738531|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738532|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738533|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738534|NCT01657370|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738535|NCT01657370|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738536|NCT01657370|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738537|NCT01657370|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738538|NCT01657370|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738539|NCT01657370|O1|Outcome|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738540|NCT01657370|O5|Outcome|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738541|NCT01657370|O4|Outcome|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738542|NCT01657370|O3|Outcome|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738543|NCT01657370|O2|Outcome|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738544|NCT01657370|O1|Outcome|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
745867|NCT01627002|O2|Outcome|Part A PA401 0.3 mg|
738545|NCT01657370|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738546|NCT01657370|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738547|NCT01657370|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738548|NCT01657370|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738549|NCT01657370|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738550|NCT01657370|E1|Reported Event|Placebo|MK-1602 placebo-matching tablet orally for 3 doses: Dose 1 at the onset of a moderate or severe migraine (Day 1), Dose 2 in the evening of Day 3 and Dose 3 on Day 4. After 2 hours participants were able to take rescue medication if necessary.
738551|NCT01657292|B1|Baseline|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
738552|NCT01657292|P1|Participant Flow|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
738553|NCT01657292|O1|Outcome|Entire Study Population|All patients treated with Oleogel-S10 and Octenilin® wound gel.
738554|NCT01657292|E4|Reported Event|Localized AE Both Wound Halves|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred at both the Octenilin® wound half and Oleogel-S10 wound half in one patient are reported under this arm.
738555|NCT01657292|E3|Reported Event|Octenilin Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Octenilin® wound half are reported under this arm.
738556|NCT01657292|E2|Reported Event|Oleogel-S10 Localized AE|All patients treated with Oleogel-S10 and Octenilin® wound gel. Application site reactions which occurred only at the Oleogel-S10 wound half are reported under this arm.
738557|NCT01657292|E1|Reported Event|Entire Study Population - Systemic AEs|All patients treated with Oleogel-S10 and Octenilin® wound gel. Systemic AEs which are not localized to the wound application site are reported under this arm.
738558|NCT01657032|B3|Baseline|Total|Total of all reporting groups
738559|NCT01657032|B2|Baseline|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738560|NCT01657032|B1|Baseline|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738561|NCT01657032|P2|Participant Flow|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738690|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738691|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738562|NCT01657032|P1|Participant Flow|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738563|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738564|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738565|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738618|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
745868|NCT01627002|O1|Outcome|Part A PA401 0.1 mg|
738566|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738567|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738568|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738569|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738570|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738571|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738572|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738573|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738574|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738575|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738576|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738577|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738578|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738619|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738857|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738579|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738580|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738581|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738582|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738583|NCT01657032|O2|Outcome|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738584|NCT01657032|O1|Outcome|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738585|NCT01657032|E2|Reported Event|Lactobacillus GG and Placebo|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~placebo (glucose), dose 3 g, once daily orally until diarrhea stopped~Placebo: Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738586|NCT01657032|E1|Reported Event|Lactobacillus GG and Smectite|"Children received:~LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days and~smectite, dose 3 g, once daily orally until diarrhea stopped~Smectite: Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.~Lactobacillus GG: All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite"
738587|NCT01657019|B1|Baseline|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
745483|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
738588|NCT01657019|P1|Participant Flow|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738589|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738590|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738591|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738592|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738593|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
745869|NCT01627002|E9|Reported Event|Part B Placebo|
738594|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738595|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738596|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738597|NCT01657019|O1|Outcome|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738598|NCT01657019|E1|Reported Event|All Participants|Participants initially received lisdexamfetamine dimesylate, 30 mg administered orally, once daily during the dose optimization phase, regardless of their treatment assignment in the antecedent study. The dose was increased to an optimal dose of either 50 or 70 mg administered orally, once daily. Participants received treatment for a total of 52 weeks, then were followed for 1 week.
738599|NCT01656967|B3|Baseline|Total|Total of all reporting groups
738600|NCT01656967|B2|Baseline|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738601|NCT01656967|B1|Baseline|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738602|NCT01656967|P2|Participant Flow|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738603|NCT01656967|P1|Participant Flow|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738604|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738605|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738606|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use~first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
738607|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera~first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
738692|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738693|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738694|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738608|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use~first-attempt success rate for SGA placement for the ILMA group (30/33, 90.9%, P = 1.0)"
738609|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera~first-attempt success rate for SGA placement for the Aura-i group (30/33, 90.9%)"
738610|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738611|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738612|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738613|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738614|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738615|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738616|NCT01656967|O2|Outcome|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738617|NCT01656967|O1|Outcome|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738852|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738620|NCT01656967|E2|Reported Event|LMA Fastrach|"The LMA Fastrach Single Use Laryngeal Mask Airway (The Laryngeal Mask Airway Company, California) will be placed, followed by blind intubation using the LMA Fastrach EndoTracheal Tube.~LMA Fastrach Single Use"
738621|NCT01656967|E1|Reported Event|AMBU Aura-I/aScope 2|"First, the AMBU Aura-I LMA will be inserted. Then, then patient will be intubated with assistance of the AMBU aScope 2 disposable fiberoptic system.~AMBU Aura-I LMA and aScope 2 Disposable Fiberoptic Camera"
738622|NCT01656889|B3|Baseline|Total|Total of all reporting groups
738623|NCT01656889|B2|Baseline|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738624|NCT01656889|B1|Baseline|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738625|NCT01656889|P2|Participant Flow|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738626|NCT01656889|P1|Participant Flow|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738627|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738628|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738629|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738630|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738631|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738632|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738633|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738634|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
745484|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
738636|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738637|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738638|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738639|NCT01656889|O2|Outcome|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738640|NCT01656889|O1|Outcome|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738641|NCT01656889|E2|Reported Event|Vehicle|"Vehicle Control (fibrinogen solution & thrombin solution without cells)~Vehicle"
738642|NCT01656889|E1|Reported Event|HP802-247|"HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.~HP-802-247: HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days."
738643|NCT01656850|B3|Baseline|Total|Total of all reporting groups
738644|NCT01656850|B2|Baseline|NCEP Diet First, Then Almond Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
738645|NCT01656850|B1|Baseline|Almond Diet First, Then NCEP Diet|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
738646|NCT01656850|P2|Participant Flow|NCEP Diet First, Then Whole Almonds Diet|run in 2 weeks, NCEP diet Intervention (3 months), Washout (2 weeks), whole almonds Intervention (3 months)
738647|NCT01656850|P1|Participant Flow|Whole Almonds First, Then NCEP Diet|run in 2 weeks, whole almonds diet Intervention (3 months), Washout (2 weeks), and then NCEP diet Intervention (3 months)
738648|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738649|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738650|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738651|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738652|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738653|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738654|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738655|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738656|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738657|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738658|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738659|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738660|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738661|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738662|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738663|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738664|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738665|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738666|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738667|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738668|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738669|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738670|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738671|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738672|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738673|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738674|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738675|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738676|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738677|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738678|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738679|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738680|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738681|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738682|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738683|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738684|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738685|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738686|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738687|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738688|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738689|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738696|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738697|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738698|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738699|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738700|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738701|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738702|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738703|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738704|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738705|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738706|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738707|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738708|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738709|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738710|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738711|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738712|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
738713|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
738714|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
738853|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
745870|NCT01627002|E8|Reported Event|Part B PA401 3.0 mg|
738715|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
738716|NCT01656850|O4|Outcome|Alm After|after consuming almond diet for 3 months
738717|NCT01656850|O3|Outcome|Alm Before|before consuming almond diet
738718|NCT01656850|O2|Outcome|Con After|after consuming NCEP step II diet for 3 months
738719|NCT01656850|O1|Outcome|Con Before|before consuming NCEP step II diet
738720|NCT01656850|O2|Outcome|NCEP Step 2 Diet|"follow NCEP step 2 diet~NCEP Step 2 diet: follow NCEP step 2 diet"
738721|NCT01656850|O1|Outcome|Whole Almonds|"whole almonds to replace 20% daily calorie intake~whole almonds: Whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake."
738722|NCT01656850|E2|Reported Event|NCEP Diet|participants received NCEP diet for 3 months
738723|NCT01656850|E1|Reported Event|Whole Almond Diet|participants received experiment diet containing 20% calorie from whole almond
738724|NCT01656772|B3|Baseline|Total|Total of all reporting groups
738725|NCT01656772|B2|Baseline|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
738726|NCT01656772|B1|Baseline|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
738727|NCT01656772|P2|Participant Flow|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
738728|NCT01656772|P1|Participant Flow|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
738729|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
738730|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
738731|NCT01656772|O2|Outcome|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
738732|NCT01656772|O1|Outcome|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
738733|NCT01656772|E2|Reported Event|Vdrive Lasso Navigation|"Use of the Vdrive to remotely and robotically control the manipulation of a Lasso catheter~Vdrive Lasso navigation: Remote robotic Lasso navigation"
738734|NCT01656772|E1|Reported Event|Manual Lasso Navigation|"Use of conventional manual navigation techniques with the Lasso catheter~Manual Lasso navigation: Manually maneuver a Lasso catheter"
738735|NCT01656759|B3|Baseline|Total|Total of all reporting groups
738736|NCT01656759|B2|Baseline|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
738737|NCT01656759|B1|Baseline|Control Group|Control group. Will not receive the fibrin spray.
738738|NCT01656759|P2|Participant Flow|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
738739|NCT01656759|P1|Participant Flow|Control Group|Control group. Will not receive the fibrin spray.
738740|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
738741|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
738796|NCT01656408|B1|Baseline|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738742|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
738743|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
738744|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
738745|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
738746|NCT01656759|O2|Outcome|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
738747|NCT01656759|O1|Outcome|Control Group|Control group. Will not receive the fibrin spray.
738748|NCT01656759|E2|Reported Event|Treatment Group--Evicel Fibrin Spray|"Patient will receive the fibrin spray after implantation of device but before the wound is closed.~Patients will be randomized to receive spray or not and postop parameters measured.~Evicel Fibrin Spray: 10cc syringe dose, once at the end of TKA"
738749|NCT01656759|E1|Reported Event|Control Group|Control group. Will not receive the fibrin spray.
738750|NCT01656486|B1|Baseline|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
738751|NCT01656486|P1|Participant Flow|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
738752|NCT01656486|O1|Outcome|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
738753|NCT01656486|E1|Reported Event|Stereotactic Radiation|"Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery.~Stereotactic Radiation: Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland."
738754|NCT01656460|B1|Baseline|Stereotactic Radiation|stereotactic
738755|NCT01656460|P4|Participant Flow|Stereotactic Radiation Dose Level 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
738756|NCT01656460|P3|Participant Flow|Stereotactic Radiation Dose Level 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
738757|NCT01656460|P2|Participant Flow|Stereotactic Radiation Dose Level 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
738758|NCT01656460|P1|Participant Flow|Stereotactic Radiation Dose Level 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
738759|NCT01656460|O4|Outcome|Arm 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
738760|NCT01656460|O3|Outcome|Arm 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
738761|NCT01656460|O2|Outcome|Arm 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
738762|NCT01656460|O1|Outcome|Arm 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
738763|NCT01656460|E4|Reported Event|Arm 4|Radiation: Stereotactic radiation Arm 4 Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
738764|NCT01656460|E3|Reported Event|Arm 3|Radiation: Stereotactic radiation Arm 3 Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
738765|NCT01656460|E2|Reported Event|Arm 2|Radiation: Stereotactic radiation Arm 2 Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
738766|NCT01656460|E1|Reported Event|Arm 1|"Radiation: Stereotactic radiation Arm 1 Dose Levels Dose per Fraction Total Dose~1 8 Gy 16 Gy"
738767|NCT01656434|B3|Baseline|Total|Total of all reporting groups
738768|NCT01656434|B2|Baseline|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738769|NCT01656434|B1|Baseline|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738770|NCT01656434|P2|Participant Flow|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738771|NCT01656434|P1|Participant Flow|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738772|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738773|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738774|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738775|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738776|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738777|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738778|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738779|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738780|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738854|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738781|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738782|NCT01656434|O2|Outcome|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738783|NCT01656434|O1|Outcome|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738784|NCT01656434|E2|Reported Event|NETA-EE|Participants received a NETA-EE tablet (1 mg norethisterone acetate and 10 μg ethinylestradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NETA-EE tablets on Days 1 to 24; EE 10 μg tablets on Days 25 and 26; and ferrous fumarate 75 mg tablets on Days 27 and 28.
738785|NCT01656434|E1|Reported Event|NOMAC-E2|Participants received a NOMAC-E2 tablet (2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol), taken orally once daily for 13 cycles. Each cycle was 28 days. For each cycle, participants received NOMAC-E2 tablets on Days 1 to 24 and placebo tablets on Days 25 to 28.
738786|NCT01656408|B11|Baseline|Total|Total of all reporting groups
738787|NCT01656408|B10|Baseline|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
738788|NCT01656408|B9|Baseline|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
738789|NCT01656408|B8|Baseline|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
738790|NCT01656408|B7|Baseline|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
738791|NCT01656408|B6|Baseline|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
738792|NCT01656408|B5|Baseline|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
738793|NCT01656408|B4|Baseline|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738794|NCT01656408|B3|Baseline|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738795|NCT01656408|B2|Baseline|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738797|NCT01656408|P10|Participant Flow|Panel J – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
738798|NCT01656408|P9|Participant Flow|Panel I – Participants With Mild to Moderate Hypertension|12 participants were randomly assigned to receive MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28); 6 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
738799|NCT01656408|P8|Participant Flow|Panel H – Participants With Resistant Hypertension|In Panel with crossover design, 4 participants were randomly assigned to receive active drug (MK-8150) in Period 1 and placebo in Period 2 and 4 participants were randomly assigned to receive placebo in Period 1 and active drug in Period 2. Active drug regimen was MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10); placebo regimen was placebo once daily on Days 1-10
738800|NCT01656408|P7|Participant Flow|Panel G – Healthy Participants|8 participants were randomly assigned to receive MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28); 2 participants were randomly assigned to receive placebo once daily on Days 1-28. Dose administered could be increased or decreased based on defined criteria
738801|NCT01656408|P6|Participant Flow|Panel F – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 6 mg on Day 1 and to also receive MK-8150 4 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
738855|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
738802|NCT01656408|P5|Participant Flow|Panel E – Elderly Participants With Mild/Moderate Hypertension|6 participants were randomly assigned to receive a single dose of MK-8150 3 mg on Day 1 and to also receive MK-8150 2 mg once daily on Days 6-15 (10 days of multiple dose administration); 3 participants were randomly assigned to receive placebo (single dose) on Day 1 and once daily on Days 6-15
738803|NCT01656408|P4|Participant Flow|Panel D – Participants With Mild to Moderate Hypertension|5 participants were randomly assigned to receive MK-8150 15 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738804|NCT01656408|P3|Participant Flow|Panel C – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 20 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738805|NCT01656408|P2|Participant Flow|Panel B – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 10 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738806|NCT01656408|P1|Participant Flow|Panel A – Participants With Mild to Moderate Hypertension|6 participants were randomly assigned to receive MK-8150 5 mg once daily and 2 participants were randomly assigned to receive placebo once daily for 10 days
738807|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
738808|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738809|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
738810|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738811|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
738812|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738813|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
738814|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738815|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
738816|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738817|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
738818|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738819|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
738820|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738821|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
738822|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738823|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
738824|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738825|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
738826|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738827|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
738828|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738829|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
738830|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738831|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
738832|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738833|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
738834|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738835|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
745485|NCT01628848|E2|Reported Event|Placebo|Placebo transdermal patch
738836|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738837|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
738838|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738839|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738840|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738841|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738842|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738843|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738844|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738845|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738846|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738847|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738848|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738849|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738850|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738851|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738858|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738859|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738860|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
738861|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738862|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738863|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738864|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738865|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
738866|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738867|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738868|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738869|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738870|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
738871|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738872|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738873|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738874|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738875|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738876|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738877|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738878|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738879|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738880|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738881|NCT01656408|O2|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738882|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738883|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738884|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738885|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738886|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738887|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738888|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738889|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738890|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738891|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
738892|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
738946|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738893|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
738894|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
738895|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
738896|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
738897|NCT01656408|O2|Outcome|Panel F – MK-8150 4 mg Multiple Dose Administration|Multiple dose administration of MK-8150 4 mg once daily on Days 6-15 in Panel F
738898|NCT01656408|O1|Outcome|Panel E – MK-8150 2 mg Multiple Dose Administration|Multiple dose administration of MK-8150 2 mg once daily on Days 6-15 in Panel E
738899|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
738900|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
738901|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
738902|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
738903|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
738904|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
738905|NCT01656408|O2|Outcome|Panel F – MK-8150 6 mg Single Dose|Single dose of MK-8150 6 mg administered on Day 1 in Panel F. No drug was administered on Days 2-5
745871|NCT01627002|E7|Reported Event|Part B PA401 1.0 mg|
738906|NCT01656408|O1|Outcome|Panel E – MK-8150 3 mg Single Dose|Single dose of MK-8150 3 mg administered on Day 1 in Panel E. No drug was administered on Days 2-5
738907|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738908|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738909|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738910|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738911|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738912|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738913|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738914|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738915|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738916|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738917|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738918|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738919|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738920|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738921|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738922|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738923|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
738924|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738925|NCT01656408|O2|Outcome|Panel J – Placebo|Placebo once daily on Days 1-28
738926|NCT01656408|O1|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738927|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
738928|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738929|NCT01656408|O2|Outcome|Panel I – Placebo|Placebo once daily on Days 1-28
738930|NCT01656408|O1|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738931|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
738932|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738933|NCT01656408|O2|Outcome|Panel H – Placebo|Placebo once daily on Days 1-10
738934|NCT01656408|O1|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738935|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
738936|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738937|NCT01656408|O2|Outcome|Panel G – Placebo|Placebo once daily on Days 1-28
738938|NCT01656408|O1|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738939|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738940|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738941|NCT01656408|O2|Outcome|Panel F – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738942|NCT01656408|O1|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738943|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738944|NCT01656408|O1|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738945|NCT01656408|O2|Outcome|Panel E – Placebo|Placebo (single dose) on Day 1 and once daily on Days 6-15
738947|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
738948|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738949|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738950|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738951|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738952|NCT01656408|O5|Outcome|Panel A/B/C/D – Placebo|Placebo once daily for 10 days, combining participants who received placebo in Panels A, B, C and D
738953|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738954|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738955|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738956|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738957|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
738958|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738959|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738960|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738961|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738962|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
739981|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
738963|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738964|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738965|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738966|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738967|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738968|NCT01656408|O13|Outcome|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
738969|NCT01656408|O12|Outcome|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
738970|NCT01656408|O11|Outcome|Placebo (Panel A - J)|Combines participants who received placebo in all panels
738971|NCT01656408|O10|Outcome|Panel J – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738972|NCT01656408|O9|Outcome|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738973|NCT01656408|O8|Outcome|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738974|NCT01656408|O7|Outcome|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738975|NCT01656408|O6|Outcome|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738976|NCT01656408|O5|Outcome|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738977|NCT01656408|O4|Outcome|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738978|NCT01656408|O3|Outcome|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738979|NCT01656408|O2|Outcome|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738980|NCT01656408|O1|Outcome|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738981|NCT01656408|E13|Reported Event|Screening|All enrolled participants, presents AEs with onset before first dose of study drug
738982|NCT01656408|E12|Reported Event|Post Study|All enrolled participants, presents AEs with onset after safety follow-up period after last dose of study drug
738983|NCT01656408|E11|Reported Event|Placebo (Panel A - J)|Combines participants who received placebo in all panels
738984|NCT01656408|E10|Reported Event|Panel J – MK-8150 10/20 mgEdit|MK-8150 once daily as follows: 10 mg (Days 1-7), 20 mg (Days 8-28)
738985|NCT01656408|E9|Reported Event|Panel I – MK-8150 5/10/20/40 mg|MK-8150 once daily as follows: 5 mg (Days 1-7), 10 mg (Days 8-14), 20 mg (Days 15-21), 40 mg (Days 22-28)
738986|NCT01656408|E8|Reported Event|Panel H – MK-8150 10/20 mg|MK-8150 once daily as follows: 10 mg (Days 1-2), 20 mg (Days 3-10)
738987|NCT01656408|E7|Reported Event|Panel G – MK-8150 20/30/40/60 mg|MK-8150 once daily as follows: 20 mg (Days 1-7), 30 mg (Days 8-14), 40 mg (Days 15-21), 60 mg (Days 22-28)
738988|NCT01656408|E6|Reported Event|Panel F – MK-8150 6/4 mg|Single dose of MK-8150 6 mg on Day 1 and MK-8150 4 mg once daily on Days 6-15
738989|NCT01656408|E5|Reported Event|Panel E – MK-8150 3/2 mg|Single dose of MK-8150 3 mg on Day 1 and MK-8150 2 mg once daily on Days 6-15
738990|NCT01656408|E4|Reported Event|Panel D – MK-8150 15 mg|MK-8150 15 mg once daily for 10 days
738991|NCT01656408|E3|Reported Event|Panel C – MK-8150 20 mg|MK-8150 20 mg once daily for 10 days
738992|NCT01656408|E2|Reported Event|Panel B – MK-8150 10 mg|MK-8150 10 mg once daily for 10 days
738993|NCT01656408|E1|Reported Event|Panel A – MK-8150 5 mg|MK-8150 5 mg once daily for 10 days
738994|NCT01656304|B1|Baseline|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
738995|NCT01656304|P1|Participant Flow|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
739035|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
738996|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
738997|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
738998|NCT01656304|O1|Outcome|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
738999|NCT01656304|E1|Reported Event|Treatment (Monoclonal Antibody, Antiangiogenesis)|"Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
739000|NCT01656161|B1|Baseline|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
739001|NCT01656161|P1|Participant Flow|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
739002|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
739003|NCT01656161|O1|Outcome|PK/PD Subset of 15 Participants|Pharmacokinetic/pharmacodynamic subset of 15 participants who received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
739004|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
739005|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
745872|NCT01627002|E6|Reported Event|Part A Placebo|
739006|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
739007|NCT01656161|O1|Outcome|PK/PD Subset|PK/PD subset of 15 participants included in the ITT analysis set.
739008|NCT01656161|O1|Outcome|PK/PD Subset|Pharmacokinetic/pharmacodynamic (PK/PD) subset of 15 participants included in the ITT analysis set.
739009|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
739010|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
739011|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
739012|NCT01656161|O1|Outcome|Triptorelin Embonate 22.5 mg|Subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation were administered on Day 1 and on Day 169.
739013|NCT01656161|E1|Reported Event|Triptorelin Embonate 22.5 mg|Participants received subcutaneous injections of triptorelin embonate 22.5 mg 6-month formulation administered on Day 1 and on Day 169.
739014|NCT01656031|B1|Baseline|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
739015|NCT01656031|P1|Participant Flow|High-dose Cytarabine and Clofarabine|high-dose cytarabine administered intravenously over 3 hours followed by clofarabine administered intravenously over 2 hours daily for 5 consecutive days
739016|NCT01656031|O1|Outcome|High-Dose Cytarabine and Clofarabine|
739017|NCT01656031|E1|Reported Event|High-Dose Cytarabine and Clofarabine|
739018|NCT01655498|B1|Baseline|All Subjects|All subjects who completed the fitting process (a screening criteria) and entered the treatment period.
739019|NCT01655498|P1|Participant Flow|All Subjects|All subjects who completed the fitting process and entered the treatment period, comprised the Intent-to-treat population.
739020|NCT01655498|O1|Outcome|ITT Cohort [N=61]|All subjects who entered the Treatment Period.
739021|NCT01655498|O1|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
739022|NCT01655498|O2|Outcome|Subject Fit With the VBC Device [PP]|Per Protocol cohort is defined all all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period who also completed the study without any major protocol deviations
739023|NCT01655498|O1|Outcome|Subjects Fit With the VBC Device [ITT]|ITT cohort is defined as all subjects who were successfully fit with a VBC device (now called Eclipse Insert) during the Fitting Period
739024|NCT01655498|E1|Reported Event|ITT Cohort [N=61]|Adverse Events reported during the Screening and 1-Month Treatment Period.
739025|NCT01655381|B1|Baseline|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739026|NCT01655381|P1|Participant Flow|Tocilizumab|Tocilizumab 8 milligrams per kilogram (mg/kg) administered intravenously once every 4 weeks during a minimum of 104 weeks.
739027|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
739028|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks through Week 104.
739029|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739030|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739031|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739032|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739033|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739034|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739036|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739037|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739038|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739039|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739040|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739041|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739042|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739043|NCT01655381|O1|Outcome|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739044|NCT01655381|E1|Reported Event|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously once every 4 weeks during a minimum of 104 weeks.
739045|NCT01655329|B1|Baseline|Radiologists|Board Certified Radiologists
739046|NCT01655329|P1|Participant Flow|Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images. The radiologists reviewed each radiograph using one or the alternate presentation
739047|NCT01655329|O9|Outcome|Confidence on Tube Placement|The confirm image increases my confidence with respect to tube placement.
743305|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
739048|NCT01655329|O8|Outcome|Need for Window/Level Manipulation|The standard image required less window/level manipulation
739049|NCT01655329|O7|Outcome|Confidence on Line Placement|The modified image increased my confidence with respect to line placement
739050|NCT01655329|O6|Outcome|Image Quality Radioopaque Regions|Image quality in the opaque image areas is superior on the confirm image
739051|NCT01655329|O5|Outcome|Overall Image Quality|Overall image quality is superior on the standard image
739052|NCT01655329|O4|Outcome|Cardiac Related Wires|Cardiac related wires are easier to see on the standard image
739053|NCT01655329|O3|Outcome|Venous Catheters|Venous catheters easier to see on modified image
739054|NCT01655329|O2|Outcome|Pleural Drain Visibility|Pleural drains are easier to see on the standard image.
739055|NCT01655329|O1|Outcome|Reading Time Estimate by Radiologists|The modified image will reduce reading time.
739056|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
739057|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
739058|NCT01655329|O2|Outcome|Modified Chest Radiographs|This group of chest radiographs will be presented with the modified image. The modified image is intended to increase the visibility of tubes, lines and wires on chest radiographs. Each radiologist interpreted half the images as conventional images and half as processed images.
739059|NCT01655329|O1|Outcome|Standard Chest Radiographs|The radiologists will be viewing two groups of chest images. The first group are standard chest radiographs. The second group are the processed images. These radiographs were randomly placed into two groups. The radiologists were randomly placed in two groups. Each of these two groups interpreted half of the standard chest radiograph without processing and half with the special processing. The other group of radiologists interpreted the other half of the normal and the other half of the processed images.
739060|NCT01655329|E1|Reported Event|Radiologists|
739061|NCT01655043|B1|Baseline|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
739062|NCT01655043|P1|Participant Flow|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
739063|NCT01655043|O1|Outcome|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
739064|NCT01655043|E1|Reported Event|Coronary Artery Disease Patients|Patients with suspected coronary artery disease prospectively recruited for myocardial perfusion MRI. All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar, Lantheus) at both stress and rest. Stress to be induced using 5 ml intravenous (IV) regadenoson (Lexiscan, Astellas US LLC), and the effects of regadenoson were reversed with 50 mg IV aminophylline following the completion of stress imaging.
739065|NCT01654887|B3|Baseline|Total|Total of all reporting groups
739066|NCT01654887|B2|Baseline|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
745486|NCT01628848|E1|Reported Event|SPM 962|SPM 962 transdermal patch
739067|NCT01654887|B1|Baseline|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739068|NCT01654887|P2|Participant Flow|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739069|NCT01654887|P1|Participant Flow|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739070|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739071|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739072|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739073|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739074|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739075|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739076|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739077|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739078|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739079|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739080|NCT01654887|O2|Outcome|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739081|NCT01654887|O1|Outcome|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739082|NCT01654887|E2|Reported Event|Chest X-Ray|Patients in the control arm underwent sequential imaging with CXR followed by LUS.
739083|NCT01654887|E1|Reported Event|Lung Ultrasound|Patients in the investigational arm received a LUS. If there was clinical uncertainty after ultrasound, clinicians had the option to obtain CXR.
739084|NCT01654861|B1|Baseline|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
739085|NCT01654861|P1|Participant Flow|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
739086|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
739087|NCT01654861|O1|Outcome|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
739088|NCT01654861|E1|Reported Event|HDIVC|"Gemcitabine (Gemzar), Intravenous and oral Ascorbic Acid (Vitamin C).~Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C): Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment."
739089|NCT01654666|B4|Baseline|Total|Total of all reporting groups
739090|NCT01654666|B3|Baseline|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739091|NCT01654666|B2|Baseline|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739092|NCT01654666|B1|Baseline|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739093|NCT01654666|P3|Participant Flow|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739094|NCT01654666|P2|Participant Flow|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739806|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739095|NCT01654666|P1|Participant Flow|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739096|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739097|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739098|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739148|NCT01654536|P2|Participant Flow|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739149|NCT01654536|P1|Participant Flow|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739099|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739100|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739101|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739102|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739103|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739104|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739105|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739106|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739107|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739108|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739881|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739109|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739110|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739111|NCT01654666|O3|Outcome|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739112|NCT01654666|O2|Outcome|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739113|NCT01654666|O1|Outcome|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739150|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739725|NCT01652729|P2|Participant Flow|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739114|NCT01654666|E3|Reported Event|Sham RIPC Group|"Treatment:Patients in this group received standard medical therapy and sham RIPC treatment for at least 2 weeks before carotid artery stenting.~Sham remote ischemic preconditioning: Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739115|NCT01654666|E2|Reported Event|Control Group|"Treatment:Patients in this group received standard medical therapy alone for at least 2 weeks before carotid artery stenting.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739116|NCT01654666|E1|Reported Event|RIPC Group|"Treatment:Patients in this group received standard medical therapy and remote ischemic preconditioning (RIPC) treatment for at least 2 weeks before carotid artery stenting.~Remote ischemic preconditioning: Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.~Carotid Artery Stenting: Carotid Artery Stenting is an invasive therapy of carotid artery stenosis."
739117|NCT01654601|B3|Baseline|Total|Total of all reporting groups
739118|NCT01654601|B2|Baseline|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739119|NCT01654601|B1|Baseline|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739120|NCT01654601|P2|Participant Flow|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739121|NCT01654601|P1|Participant Flow|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739122|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739123|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739124|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739125|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739126|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739127|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739128|NCT01654601|O2|Outcome|B Group|Clozaril tablet 100mg twice daily in first intervention period and DWCZP tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739129|NCT01654601|O1|Outcome|A Group|DWCZP tablet 100mg twice daily in first intervention period and Clozaril tablet 100mg twice daily in second intervention period (no washout period, Intervention period : 10days)
739130|NCT01654601|E2|Reported Event|B Group|1.1st Administration - Clozaril tablet 100mg Mutiple dose 2.2nd Administration - DWCZP tablet 100mg Mutiple dose
739131|NCT01654601|E1|Reported Event|A Group|1.1st Administration - DWCZP tablet 100mg Mutiple dose 2.2nd Administration - Clozaril tablet 100mg Mutiple dose
739132|NCT01654549|B3|Baseline|Total|Total of all reporting groups
745487|NCT01628692|B7|Baseline|Total|Total of all reporting groups
739133|NCT01654549|B2|Baseline|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
739134|NCT01654549|B1|Baseline|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
739135|NCT01654549|P2|Participant Flow|H.Pylori Eradication|H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
739136|NCT01654549|P1|Participant Flow|Lifestyle Modification|Obtaining ideal body weight by calorie restriction diet and programmed physical activity
739137|NCT01654549|O6|Outcome|Liver Fat Content Change in Lifestyle Modification|The change of liver fat content from baseline to the end of study in lifestyle modification group
739138|NCT01654549|O5|Outcome|Liver Fat Content Change in H.Pylori Eradication|The change of liver fat content from baseline to the end of study in H.pylori eradication group
739139|NCT01654549|O4|Outcome|Liver Fat Content in Lifestyle Modification at 8 Weeks|Liver fat content in lifestyle modification group at 8 weeks
739140|NCT01654549|O3|Outcome|Liver Fat Content in Lifestyle Modification at Baseline|Liver fat content in lifestyle modification group at baseline
739141|NCT01654549|O2|Outcome|Liver Fat Content in H.Pylori Eradication at 8 Weeks|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at 8 weeks
739142|NCT01654549|O1|Outcome|Liver Fat Content in H.Pylori Eradication at Baseline|Liver fat content in Helicobacter pylori eradication plus lifestyle modification group at baseline
739143|NCT01654549|E2|Reported Event|No Intervention|Lifestyle modification
739144|NCT01654549|E1|Reported Event|H. Pylori Eradication|Helicobacter pylori eradication
739145|NCT01654536|B3|Baseline|Total|Total of all reporting groups
739146|NCT01654536|B2|Baseline|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739147|NCT01654536|B1|Baseline|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
743306|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
739151|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739152|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739153|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739154|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739155|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739156|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739157|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739158|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739159|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739160|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739161|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739162|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739163|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739164|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739165|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739166|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739167|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739168|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739169|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739683|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739170|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739171|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetona (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739172|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739173|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739174|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739175|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739176|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739177|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739178|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739179|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739180|NCT01654536|O2|Outcome|Ciclesonide Nasal Spray|"Omnaris (ciclesonide) nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739181|NCT01654536|O1|Outcome|Ciclesonide Nasal Aerosol|"Zetonna (ciclesonide) nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
745873|NCT01627002|E5|Reported Event|Part A PA401 10 mg|
739182|NCT01654536|E2|Reported Event|Ciclesonide Nasal Spray|"ciclesonide nasal spray 200 mcg~ciclesonide nasal spray: ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)"
739183|NCT01654536|E1|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol 74 mcg~ciclesonide nasal aerosol: ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)"
739184|NCT01654523|B1|Baseline|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
739185|NCT01654523|P1|Participant Flow|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
739186|NCT01654523|O1|Outcome|Awareness Enhancement and Monitoring Device|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
739187|NCT01654523|E1|Reported Event|Treatment Arm|"Open trial with no randomization~Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania: Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania"
739188|NCT01654302|B3|Baseline|Total|Total of all reporting groups
739189|NCT01654302|B2|Baseline|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
739190|NCT01654302|B1|Baseline|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch (placebo) at the Second Intervention (Day 7).
739191|NCT01654302|P2|Participant Flow|Placebo Then Synera|Subjects received the Inactive patch (placebo) during the First Intervention (Day 1) and the Synera patch at the Second Intervention (Day 7).
739192|NCT01654302|P1|Participant Flow|Synera Then Placebo|Subjects received the Synera patch during the First Intervention (Day 1) and the Inactive patch at the Second Intervention (Day 7).
739193|NCT01654302|O2|Outcome|Inactive Patch|placebo: placebo
739194|NCT01654302|O1|Outcome|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
739195|NCT01654302|E2|Reported Event|Inactive Patch|placebo: placebo
739196|NCT01654302|E1|Reported Event|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch: 70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
739197|NCT01654276|B1|Baseline|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739198|NCT01654276|P1|Participant Flow|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739199|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739200|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739201|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739202|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739203|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739204|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739205|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739206|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739207|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739208|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739209|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739210|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739211|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739212|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739292|NCT01653782|B1|Baseline|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
739213|NCT01654276|O1|Outcome|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739214|NCT01654276|E1|Reported Event|Gout and Hyperuricemia|"Adult patients (age > 21 years) with gout and hyperuricemia (serum uric acid > 7.0 mg/dl in men and >6.0 mg/dl in women) requiring uric acid lowering therapy.~Febuxostat: One 40 mg tablet once a day for 6 months"
739215|NCT01654263|B7|Baseline|Total|Total of all reporting groups
739216|NCT01654263|B6|Baseline|IIBB: Age 65-74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739217|NCT01654263|B5|Baseline|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739218|NCT01654263|B4|Baseline|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739219|NCT01654263|B3|Baseline|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739220|NCT01654263|B2|Baseline|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
739221|NCT01654263|B1|Baseline|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
739222|NCT01654263|P6|Participant Flow|IIBB: Age 65 - 74, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739223|NCT01654263|P5|Participant Flow|IIAA: Age 55-64, Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739224|NCT01654263|P4|Participant Flow|IIB: Age 65-74, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739225|NCT01654263|P3|Participant Flow|IIA: Age 55-64, Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739226|NCT01654263|P2|Participant Flow|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
739227|NCT01654263|P1|Participant Flow|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
739228|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739684|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739229|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739230|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
739231|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739232|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739233|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
739234|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739235|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739236|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
739237|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739238|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739239|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
739726|NCT01652729|P1|Participant Flow|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739240|NCT01654263|O3|Outcome|Group IIAA/BB: Previous PPSV23, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739241|NCT01654263|O2|Outcome|Group IIA/B: Previous PPSV23, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739242|NCT01654263|O1|Outcome|Group IA/B: Pneumococcal Vaccine-naive, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-74.
739243|NCT01654263|E6|Reported Event|IIBB: Previous PPSV23, Age 65-74, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739244|NCT01654263|E5|Reported Event|IIAA: Previous PPSV23, Age 55-64, Two Injections|Open-label, randomized PCV13 given as a 0.5 mL IM injection in the right arm and 0.5 mL PCV 13 IM in the left arm, to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739245|NCT01654263|E4|Reported Event|IIB: Previous PPSV23, Age 65-74, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 65-74 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739246|NCT01654263|E3|Reported Event|IIA: Previous PPSV23, Age 55-64, Single Injection|Open-label, randomized PCV13 given as a 0.5 mL IM injection to adults ages 55-64 with previous 23-valent pneumococcal polysaccharide vaccine (PPSV23) 3-7 years prior to enrollment.
739247|NCT01654263|E2|Reported Event|IB: Pneumococcal Vaccine-naive, Age 65-74, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 65-74.
739248|NCT01654263|E1|Reported Event|IA: Pneumococcal Vaccine-naive, Age 55-64, Single Injection|Open- label, 13-valent pneumococcal conjugate vaccine (PCV13) given as 0.5 mL intramuscular (IM) injection to vaccine-naive adults ages 55-64.
739249|NCT01654250|B3|Baseline|Total|Total of all reporting groups
739250|NCT01654250|B2|Baseline|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739251|NCT01654250|B1|Baseline|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739252|NCT01654250|P2|Participant Flow|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739253|NCT01654250|P1|Participant Flow|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739254|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739255|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739256|NCT01654250|O1|Outcome|Entire Study Population|All randomized participants received either placebo-matched to NW09 or NW09 chewable tablets once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739257|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739258|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739259|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739260|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739261|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739262|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739263|NCT01654250|O2|Outcome|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739264|NCT01654250|O1|Outcome|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739265|NCT01654250|E2|Reported Event|NWP09 (OL Phase; DB Phase)|NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 mg and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739266|NCT01654250|E1|Reported Event|Placebo (OL Phase; DB Phase)|Placebo-matched to NWP09 chewable tablet once daily optimized dose (optimized during the 1 to 6 weeks OL phase at a starting dose of 20 milligram [mg] and titrated at 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg per day) for 1 week.
739267|NCT01654224|B3|Baseline|Total|Total of all reporting groups
739268|NCT01654224|B2|Baseline|SD IIV|Frail adults 65 years and older who received Fluzone Standard Dose intramuscularly
739269|NCT01654224|B1|Baseline|HD IIV|Frail adults 65 years and older who received Fluzone High Dose intramuscularly
739270|NCT01654224|P2|Participant Flow|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
739271|NCT01654224|P1|Participant Flow|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
739272|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
739273|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
739274|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
739275|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
739276|NCT01654224|O2|Outcome|Standard Dose Inactivated Influenza Vaccine|"For SDIV, 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg of each strain) of influenza virus hemagglutinin~Standard Dose Inactivated Influenza Vaccine: 0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin"
739277|NCT01654224|O1|Outcome|High Dose Inactivated Influenza Vaccine|"For HDIV,0.5 ml of high dose inactivated influenza vaccine consisting of a total of 180mcg (60 mcg each strain) of influenza virus hemagglutinin~High Dose Inactivated Influenza Vaccine: 0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin"
739278|NCT01654224|E2|Reported Event|SD IIV|Frail adults 65 years or older who received Fluzone Standard Dose intramuscularly
739279|NCT01654224|E1|Reported Event|HD IIV|Frail adults 65 years or older who received Fluzone High Dose intramuscularly.
739280|NCT01654107|B3|Baseline|Total|Total of all reporting groups
753686|NCT01589822|B4|Baseline|Total|Total of all reporting groups
739281|NCT01654107|B2|Baseline|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739282|NCT01654107|B1|Baseline|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739283|NCT01654107|P2|Participant Flow|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739284|NCT01654107|P1|Participant Flow|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739285|NCT01654107|O2|Outcome|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739286|NCT01654107|O1|Outcome|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739287|NCT01654107|E2|Reported Event|Clearing The Air|"Clearing the Air Smoking Cessation intervention - 8 weeks counseling + 12 weeks nicotine lozenge~Clearing The Air: 8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739288|NCT01654107|E1|Reported Event|Persistence Targeted Smoking Cessation|"Persistence Targeted Smoking Cessation - 8 weeks counseling + 12 weeks nicotine lozenge~Persistence Targeted Smoking Cessation: 8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)~Nicotine lozenge: 12-weeks 4mg nicotine lozenge"
739289|NCT01653782|B4|Baseline|Total|Total of all reporting groups
739290|NCT01653782|B3|Baseline|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 2 hours, twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
739291|NCT01653782|B2|Baseline|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
739293|NCT01653782|P3|Participant Flow|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes of intructor-led yoga each week) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
739294|NCT01653782|P2|Participant Flow|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
739295|NCT01653782|P1|Participant Flow|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
739296|NCT01653782|O3|Outcome|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for 1 hour, twice a week (120 minutes each week of instructor-led yoga) for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
739297|NCT01653782|O2|Outcome|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
739298|NCT01653782|O1|Outcome|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
739299|NCT01653782|E3|Reported Event|Medical Yoga|Guided kundalini yoga sessions specific for low back pain for twice a week for 6 weeks. Cd recording for home practice recommended once per day.A written self care pamphlet
739300|NCT01653782|E2|Reported Event|Self Care Advice to Stay Active|"Evidence based advice from caregiver to stay active and exercise~Self care advice : Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet"
739301|NCT01653782|E1|Reported Event|Exercise|Guided exercise at a gym focusing on strength training. Twice a week during 6 weeks. A written self care pamphlet
739302|NCT01653743|B3|Baseline|Total|Total of all reporting groups
739303|NCT01653743|B2|Baseline|Urinary Human Chorionic Gonadotropin (u-hCG)|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739304|NCT01653743|B1|Baseline|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739305|NCT01653743|P2|Participant Flow|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739306|NCT01653743|P1|Participant Flow|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739307|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739308|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739309|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739323|NCT01653509|P1|Participant Flow|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739727|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
739310|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739311|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739312|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739313|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739314|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739315|NCT01653743|O2|Outcome|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739316|NCT01653743|O1|Outcome|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739317|NCT01653743|E2|Reported Event|u-hCG|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 IIU subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
739318|NCT01653743|E1|Reported Event|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol (starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days was done if no ovarian response was observed) for maximum of 28 days received a single dose of 250 microgram (mcg) MSJ-0011 subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
739319|NCT01653509|B3|Baseline|Total|Total of all reporting groups
739320|NCT01653509|B2|Baseline|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
739321|NCT01653509|B1|Baseline|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period. Baseline measures were determined for Safety population.
739322|NCT01653509|P2|Participant Flow|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739324|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
739325|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area at a time. A maximum of 5 patches/ day were allowed during the 10 day study period.
739326|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739327|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739328|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739329|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739330|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739331|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739332|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739333|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739334|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739335|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739336|NCT01653509|O2|Outcome|Placebo Patch|Participants applied single placebo patch to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739337|NCT01653509|O1|Outcome|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area. A maximum of 5 patches/ day were allowed during the 10 day study period.
739338|NCT01653509|E2|Reported Event|Placebo Patch|Participants applied single placebo patch to the cold sore area.
739339|NCT01653509|E1|Reported Event|Acyclovir Patch|Participants applied single patch containing acyclovir to the cold sore area.
739340|NCT01653418|B1|Baseline|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739341|NCT01653418|P1|Participant Flow|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739342|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739383|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739343|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739344|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739345|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739346|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739347|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739348|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739349|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739350|NCT01653418|O1|Outcome|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739351|NCT01653418|E1|Reported Event|V-BEAM + Stem Cell Infusion|Bortezomib IV or SC (1.3mg/m2) on Days -6, -3, +1 and +4 Carmustine IV (300mg/m2) on Day -7 Etoposide IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Cytarabine IV twice daily (100 mg/m2) on Days -6, -5, -4, and -3 Melphalan IV (140 mg/m2) on Day-2 Stem cell infusion on Day 0
739369|NCT01653158|P5|Participant Flow|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739728|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739352|NCT01653262|B1|Baseline|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739353|NCT01653262|P1|Participant Flow|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739354|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739355|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739356|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739357|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739358|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739359|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739384|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739360|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739361|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739362|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739363|NCT01653262|O1|Outcome|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739364|NCT01653262|E1|Reported Event|Brivaracetam|"The subjects will be treated with Brivaracetam (BRV) tablets 200 mg/day during 12 weeks: four 25 mg tablets, twice daily.~Based on the Investigator's judgement, at any time, the dose can be decreased to BRV 150 mg/day, 100 mg/day, or 50 mg/day. Flexible dosing, can be up- and down-titrated as needed.~At the end of the Treatment Period, the subject will either enter the N01372 long-term follow-up study or down-titrate during 4 weeks."
739365|NCT01653158|B1|Baseline|Entire Study Population|Includes all enrolled participants who received single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously at each cycle (1 cycle = 21 days).
739366|NCT01653158|P8|Participant Flow|CP-751,871 20 mg/kg + Docetaxel|"In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days).~In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1."
739367|NCT01653158|P7|Participant Flow|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739368|NCT01653158|P6|Participant Flow|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739370|NCT01653158|P4|Participant Flow|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739371|NCT01653158|P3|Participant Flow|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739372|NCT01653158|P2|Participant Flow|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739373|NCT01653158|P1|Participant Flow|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739374|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739375|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739376|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739377|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739378|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739379|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739380|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739381|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739382|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739648|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
739385|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739386|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739387|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739388|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739389|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739390|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739391|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739392|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739393|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739394|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739395|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739396|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739425|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739397|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739398|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739399|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739400|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739401|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739402|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739403|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739404|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739405|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739406|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739407|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739408|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739409|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739410|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739411|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739412|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739413|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739414|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739415|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739416|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739417|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739418|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739419|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739420|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739421|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739422|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739423|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739424|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739426|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739427|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739428|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739429|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739430|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739431|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739432|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739433|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739434|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739435|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739436|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739437|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739438|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739439|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739440|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739441|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739442|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739443|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739444|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739445|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739446|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739447|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739448|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739449|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739450|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739451|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739452|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739453|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739454|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739455|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739456|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739457|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739458|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739459|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739460|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739461|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739462|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739463|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739464|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739465|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739466|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739467|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739468|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739469|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739470|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739471|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739472|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739473|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739474|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739475|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739476|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739477|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739478|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739479|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739480|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739481|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739482|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739483|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739484|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739485|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739486|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739487|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739488|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739489|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739490|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739491|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739492|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739493|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739494|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739495|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739496|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739497|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739498|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739499|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739500|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739501|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739502|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739503|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739504|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739505|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739506|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739507|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739508|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739509|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739510|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739511|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739512|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739513|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739514|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739515|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739516|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739517|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739518|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739519|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739520|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739521|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739522|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739523|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739524|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739525|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739526|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739527|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739528|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739529|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739530|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739531|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739532|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739533|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739534|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739535|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739536|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739537|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739538|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739539|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739540|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739541|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739542|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739543|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739544|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739545|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739546|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739547|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739548|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739549|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739550|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739551|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739552|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739553|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739554|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739555|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739556|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739557|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739558|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739559|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739560|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739561|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739562|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739563|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739564|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739565|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739566|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739567|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739568|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739569|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739570|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739571|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739572|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739573|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739574|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739575|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739576|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739577|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739578|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739579|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739580|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739581|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739582|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739583|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739584|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739585|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739586|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739587|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739588|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739589|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739590|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
739591|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739592|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739593|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739594|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739595|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739596|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739597|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739598|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
739599|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739600|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739601|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739602|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739603|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739604|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739605|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739682|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739606|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
739607|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739608|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739609|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739610|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739611|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739612|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739613|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739614|NCT01653158|O8|Outcome|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
739615|NCT01653158|O7|Outcome|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739616|NCT01653158|O6|Outcome|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739617|NCT01653158|O5|Outcome|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739618|NCT01653158|O4|Outcome|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739619|NCT01653158|O3|Outcome|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739620|NCT01653158|O2|Outcome|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739621|NCT01653158|O1|Outcome|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739622|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739623|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739624|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739625|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739626|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739627|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
754223|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
739628|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739629|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739630|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739631|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739632|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739633|NCT01653158|O1|Outcome|CP-751,871 20 mg/kg + Docetaxel|Cycle 1 only: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously alone on Day 1 and single dose of CP-751,871 infusion 20 mg/kg intravenously alone on Day 2; subsequent cycles: single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 20 mg/kg intravenously on Day 1 (1 cycle = 21 days).
739634|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
739635|NCT01653158|O1|Outcome|CP-751,871 0.1-20 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1, 0.4, 0.8, 1.5, 3, 6, 10 or 20 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739664|NCT01653028|B1|Baseline|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739979|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739636|NCT01653158|E8|Reported Event|CP-751,871 20 mg/kg + Docetaxel|In the dose escalation cohort, single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously and single dose of CP-751,871 infusion 20 mg/kg intravenously were both administered on Day 1 of each cycle (1 cycle = 21 days). In the pharmacokinetic (PK) drug interaction expansion cohort, for Cycle 1 only, docetaxel was administered alone on Day 1 and CP-751,871 alone on Day 2; for subsequent cycles, docetaxel and CP-751,871 were both administered on Day 1.
739637|NCT01653158|E7|Reported Event|CP-751,871 10 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 10 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739638|NCT01653158|E6|Reported Event|CP-751,871 6 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 6 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739639|NCT01653158|E5|Reported Event|CP-751,871 3 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 3 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739640|NCT01653158|E4|Reported Event|CP-751,871 1.5 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 1.5 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739641|NCT01653158|E3|Reported Event|CP-751,871 0.8 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.8 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739642|NCT01653158|E2|Reported Event|CP-751,871 0.4 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 mg/m^2 over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.4 mg/kg intravenously on Day 1 of each cycle (1 cycle = 21 days).
739643|NCT01653158|E1|Reported Event|CP-751,871 0.1 mg/kg + Docetaxel|Single dose of docetaxel infusion up to 75 milligram/square meter (mg/m^2) over 1 hour intravenously followed by single dose of CP-751,871 infusion 0.1 milligram/kilogram (mg/kg) intravenously on Day 1 of each cycle (1 cycle = 21 days).
739644|NCT01653132|B1|Baseline|All Study Participants|Participants who received either Placebo, 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each) and submandibular ( 0.3 ml each), or Incobotulinum Toxin A 100 units, 20 units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
739645|NCT01653132|P2|Participant Flow|Incobotulinum Toxin A First, Then Placebo|Incobotulinum toxin, 100 units, diluted in 1 ml 0.9% sterile saline. 20 units (0.2 ml) were injected into each parotid gland and 30 units (0.3 ml) into each submandibular gland using anatomical landmarks
739646|NCT01653132|P1|Participant Flow|Placebo First, Then Incobotulinum Toxin A|sterile, preservative free 0.9% saline, 1 ml of saline into the parotid and submandibular glands in first intervention period
739647|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
739758|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739649|NCT01653132|O2|Outcome|Placebo|"Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .~Placebo: Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands ."
739650|NCT01653132|O1|Outcome|Incobotulinum Toxin A|"Twenty units (0.2 ml) of incobotulinum toxin A injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks~Incobotulinum Toxin A: Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks"
739651|NCT01653132|O2|Outcome|Placebo|Placebo: 1ml of preservative free sterile 0.9% saline, injected into the parotid (0.2 ml each)and submandibular ( 0.3ml each) glands of subjects
739652|NCT01653132|O1|Outcome|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each)and submandibular (30 units, 0.3ml each) glands of subjects
739653|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
739654|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
739655|NCT01653132|O2|Outcome|Incobotulinum Toxin A|Inco-A, 100 units was reconstituted with 1 ml 0.9% sterile saline (dilution: 10 units/0.1 ml). Twenty units (0.2 ml) of Inco-A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland using anatomical landmarks
739656|NCT01653132|O1|Outcome|Placebo|Sterile, preservative free 0.9% saline, 1 ml, injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
739657|NCT01653132|E2|Reported Event|Placebo|Sterile, preservative free 0.9% saline, 1 mL injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
739658|NCT01653132|E1|Reported Event|Incobotulinum Toxin|Incobotulinum Toxin 100 units diluted in 1 ml of sterile 0.9% saline injected in the parotid (20 units, 0.2 ml each) and submandibular (30 units, 0.3ml each) glands of subjects
739659|NCT01653028|B6|Baseline|Total|Total of all reporting groups
739660|NCT01653028|B5|Baseline|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739661|NCT01653028|B4|Baseline|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739662|NCT01653028|B3|Baseline|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739663|NCT01653028|B2|Baseline|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739724|NCT01652729|P3|Participant Flow|Placebo Comparator: Placebo|Placebo oral tablet once daily
739665|NCT01653028|P5|Participant Flow|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739666|NCT01653028|P4|Participant Flow|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739667|NCT01653028|P3|Participant Flow|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739668|NCT01653028|P2|Participant Flow|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739669|NCT01653028|P1|Participant Flow|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739670|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739671|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739672|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739673|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739674|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739675|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739676|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739677|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739678|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739679|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739680|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739681|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
754224|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
739685|NCT01653028|O5|Outcome|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739686|NCT01653028|O4|Outcome|Cohort 4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739687|NCT01653028|O3|Outcome|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739688|NCT01653028|O2|Outcome|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739689|NCT01653028|O1|Outcome|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739690|NCT01653028|E5|Reported Event|Cohort 5|Other Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739691|NCT01653028|E4|Reported Event|Cohort4|Malignant Peripheral Nerve Sheath Tumor patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739692|NCT01653028|E3|Reported Event|Cohort 3|Undifferentiated Sarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739693|NCT01653028|E2|Reported Event|Cohort 2|Leiomyosarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739694|NCT01653028|E1|Reported Event|Cohort 1|Liposarcoma patients receive alisertib PO BID on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
739695|NCT01652885|B1|Baseline|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739696|NCT01652885|P1|Participant Flow|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate atopic dermatitis (AD), twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739697|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739698|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739699|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739700|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739701|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739702|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739703|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739704|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739705|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739706|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739707|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739708|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739709|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739710|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739805|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739711|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739712|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739713|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739714|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739715|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739716|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739717|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739718|NCT01652885|O1|Outcome|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739719|NCT01652885|E1|Reported Event|AN2728 Topical Ointment 2 Percent|AN2728 ointment 2 percent was applied topically to treatment-targeted lesions in participant with mild to moderate AD, twice daily for up to 28 days, except on Day 1 and 8 applied once daily. Lesions were identified at Baseline (Day 1) by investigator.
739720|NCT01652729|B4|Baseline|Total|Total of all reporting groups
739721|NCT01652729|B3|Baseline|Placebo Comparator: Placebo|Placebo oral tablet once daily
739722|NCT01652729|B2|Baseline|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739723|NCT01652729|B1|Baseline|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739729|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739730|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
739731|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739732|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739733|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
739734|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739735|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739736|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
739737|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739738|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739739|NCT01652729|O3|Outcome|Placebo Comparator: Placebo|Placebo oral tablet once daily
739740|NCT01652729|O2|Outcome|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739741|NCT01652729|O1|Outcome|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739742|NCT01652729|E3|Reported Event|Placebo Comparator: Placebo|Placebo oral tablet once daily
739743|NCT01652729|E2|Reported Event|Active Comparator: Sitagliptin|Sitagliptin 100mg oral tablet once daily
739744|NCT01652729|E1|Reported Event|Experimental: Exenatide|Exenatide once weekly suspension 2mg subcutaneous injection
739745|NCT01652716|B3|Baseline|Total|Total of all reporting groups
739746|NCT01652716|B2|Baseline|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739747|NCT01652716|B1|Baseline|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
739748|NCT01652716|P2|Participant Flow|Active Comparator: Exenatide Twice Daily (BID)|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739749|NCT01652716|P1|Participant Flow|Experimental: Exenatide Once Weekly (QWS) Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
739750|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739751|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
739752|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739753|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
739754|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739755|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
739756|NCT01652716|O2|Outcome|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739757|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
740048|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
739759|NCT01652716|O1|Outcome|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
739760|NCT01652716|E2|Reported Event|Active Comparator: Exenatide BID|Exenatide 5 mcg BID for 4 weeks followed by 10 mcg BID for 24 weeks
739761|NCT01652716|E1|Reported Event|Experimental: Exenatide QWS Suspension|Exenatide suspension 2 mg weekly subcutaneous injection for 52 weeks (28 weeks plus an additional 24 weeks)
739762|NCT01652703|B7|Baseline|Total|Total of all reporting groups
739763|NCT01652703|B6|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739764|NCT01652703|B5|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739765|NCT01652703|B4|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739766|NCT01652703|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739767|NCT01652703|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739768|NCT01652703|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739769|NCT01652703|P6|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739770|NCT01652703|P5|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739771|NCT01652703|P4|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739772|NCT01652703|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739773|NCT01652703|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739774|NCT01652703|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739775|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739776|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739777|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739778|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739779|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739780|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739781|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739782|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739783|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739784|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739785|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739786|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739787|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739788|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739789|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739790|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739791|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739792|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739793|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739794|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739795|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739796|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739797|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739798|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739799|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739800|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739801|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739802|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739803|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739804|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
754225|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
739807|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739808|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739809|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739810|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739811|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739812|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739813|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739814|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739815|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739816|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739817|NCT01652703|O6|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739818|NCT01652703|O5|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739819|NCT01652703|O4|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739820|NCT01652703|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739821|NCT01652703|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739822|NCT01652703|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739823|NCT01652703|E6|Reported Event|Evolocumab Q4W 420 MG|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
739824|NCT01652703|E5|Reported Event|Evolocumab Q4W 280 MG|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
745874|NCT01627002|E4|Reported Event|Part A PA401 3.0 mg|
739825|NCT01652703|E4|Reported Event|Evolocumab Q2W 140 MG|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739826|NCT01652703|E3|Reported Event|Evolocumab Q2W 70 MG|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
739827|NCT01652703|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
739828|NCT01652703|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
739829|NCT01652690|B3|Baseline|Total|Total of all reporting groups
739830|NCT01652690|B2|Baseline|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739831|NCT01652690|B1|Baseline|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739832|NCT01652690|P2|Participant Flow|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739833|NCT01652690|P1|Participant Flow|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739834|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739835|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739836|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739837|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739838|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739839|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739840|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739841|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739842|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739843|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739844|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739845|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739846|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739847|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739848|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739849|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739850|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739851|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739852|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739853|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739854|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739855|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739856|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739857|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739858|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739859|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739860|NCT01652690|O2|Outcome|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739861|NCT01652690|O1|Outcome|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739862|NCT01652690|E2|Reported Event|Slovakia|Patients in Slovakia with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739863|NCT01652690|E1|Reported Event|Czech Republic|Patients in the Czech Republic with postmenopausal osteoporosis who received at least 1 injection of denosumab 60 mg administered subcutaneously every 6 months as part of their routine clinical care.
739864|NCT01652664|B3|Baseline|Total|Total of all reporting groups
739865|NCT01652664|B2|Baseline|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
739866|NCT01652664|B1|Baseline|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
739867|NCT01652664|P2|Participant Flow|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
739868|NCT01652664|P1|Participant Flow|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
739869|NCT01652664|O2|Outcome|Timolol|1 drop administered in each eye twice daily (once in the morning and once in the evening) for 3 months; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
739870|NCT01652664|O1|Outcome|Travoprost|1 drop administered in each eye in the evening with Travoprost vehicle in the morning for 3 months
739871|NCT01652664|E3|Reported Event|Timolol|All participants who received timolol; both concentrations of timolol (0.5% and 0.25%, based on age) were combined into a single group.
739872|NCT01652664|E2|Reported Event|Travoprost|All participants who received travoprost with vehicle
739873|NCT01652664|E1|Reported Event|Pre-Treatment|All enrolled participants
739874|NCT01652573|B3|Baseline|Total|Total of all reporting groups
739875|NCT01652573|B2|Baseline|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739876|NCT01652573|B1|Baseline|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739877|NCT01652573|P2|Participant Flow|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739878|NCT01652573|P1|Participant Flow|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739879|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739880|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739882|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739883|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739884|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739885|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739886|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739887|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739888|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739889|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739890|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739891|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739892|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739893|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739894|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739895|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739896|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739897|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739898|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739899|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739900|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739901|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739902|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739903|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739904|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739905|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739906|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739907|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739908|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739909|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739910|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739911|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739912|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739913|NCT01652573|O2|Outcome|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739914|NCT01652573|O1|Outcome|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739915|NCT01652573|E2|Reported Event|Saline Nasal Spray|"Patients will receive saline nasal spray once daily~Saline Nasal Spray Placebo"
739916|NCT01652573|E1|Reported Event|Nasal Calictonin|"Subjects will received nasal calcitonin once daily~nasal salmon calcitonin: 400 IU daily in two sprays (one to each nares)"
739917|NCT01652495|B3|Baseline|Total|Total of all reporting groups
739918|NCT01652495|B2|Baseline|Triamcinolone Acetonide|Single intrabursal injection of 40 mg (1 ml) of trimacinolone acetonide
739919|NCT01652495|B1|Baseline|Methylprednisolone Acetate|Single intrabursal injection of 40 mg (1 ml) of methylprednisolone acetate
739920|NCT01652495|P2|Participant Flow|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
739921|NCT01652495|P1|Participant Flow|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
739922|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide"
739923|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate"
739924|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
739925|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
739926|NCT01652495|O2|Outcome|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
739927|NCT01652495|O1|Outcome|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
739928|NCT01652495|E2|Reported Event|Triamcinolone Acetonide Group|"Single intrabursal injection of Triamcinolone acetonide~Triamcinolone Acetonide: Single intrabursal ultrasound guided injection"
739929|NCT01652495|E1|Reported Event|Methylprednisolone Acetate Group|"Single intrabursal injection of methylprednisolone acetate~methylprednisolone acetate: Single intrabursal ultrasound guided injection"
739930|NCT01652287|B3|Baseline|Total|Total of all reporting groups
739931|NCT01652287|B2|Baseline|Control|yogurt cultured with starter YF-L702
739932|NCT01652287|B1|Baseline|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
739933|NCT01652287|P2|Participant Flow|Control|yogurt cultured with starter YF-L702
739934|NCT01652287|P1|Participant Flow|BB-12|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
739935|NCT01652287|O2|Outcome|Control|yogurt cultured with starter YF-L702
739936|NCT01652287|O1|Outcome|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
739937|NCT01652287|E2|Reported Event|Control|yogurt cultured with starter YF-L702
739938|NCT01652287|E1|Reported Event|BB-12®|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12®-supplemented yogurt
739939|NCT01652001|B3|Baseline|Total|Total of all reporting groups
739940|NCT01652001|B2|Baseline|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
739941|NCT01652001|B1|Baseline|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
739980|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739942|NCT01652001|P2|Participant Flow|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
739943|NCT01652001|P1|Participant Flow|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
739944|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
739945|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
739946|NCT01652001|O2|Outcome|Control|"Control group was given a placebo with opaque flask(without any brand name)labeled B and with the same presentation and composition than Experimental group (excepting 1% malic acid).~Placebo: Oral spray for application into the oral cavity"
739947|NCT01652001|O1|Outcome|Malic Acid 1%|"Intervention group subjects was the delivery to the patients of a topical sialogogue, containing 1% malic acid, xylitol 10% and fluoride 0.05%(Xeros Dentaid Spray©, Dentaid, Barcelona, Spain).~Spray was transferred by foreign personnel into identical opaque flasks(without any brand name)labeled A.~Malic Acid: Oral spray for application into the oral cavity"
739948|NCT01652001|E2|Reported Event|Control|Patients treated with a placebo
739949|NCT01652001|E1|Reported Event|Malic Acid 1%|Patients treated with Malic Acid 1%
739950|NCT01651949|B4|Baseline|Total|Total of all reporting groups
739951|NCT01651949|B3|Baseline|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739952|NCT01651949|B2|Baseline|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739953|NCT01651949|B1|Baseline|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739954|NCT01651949|P3|Participant Flow|Men Who Have Sex With Men (MSM)|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739955|NCT01651949|P2|Participant Flow|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739956|NCT01651949|P1|Participant Flow|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739957|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739958|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739959|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739960|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739961|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739962|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739963|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739964|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739965|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739966|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739967|NCT01651949|O1|Outcome|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739968|NCT01651949|O3|Outcome|Men Who Have Sex With Men|Healthy MSM 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739969|NCT01651949|O2|Outcome|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739970|NCT01651949|O1|Outcome|Heterosexual Males|Healthy heterosexual males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739971|NCT01651949|E2|Reported Event|Females|Healthy females 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739972|NCT01651949|E1|Reported Event|Heterosexual and MSM Males|Healthy heterosexual and MSM males 16 to 26 years of age received 9vHPV vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
739973|NCT01651936|B3|Baseline|Total|Total of all reporting groups
739974|NCT01651936|B2|Baseline|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739975|NCT01651936|B1|Baseline|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739976|NCT01651936|P3|Participant Flow|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study.
739977|NCT01651936|P2|Participant Flow|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739978|NCT01651936|P1|Participant Flow|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739982|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739983|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739984|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739985|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739986|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739987|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739988|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739989|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739990|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739991|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739992|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739993|NCT01651936|O2|Outcome|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739994|NCT01651936|O1|Outcome|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739995|NCT01651936|E3|Reported Event|Extension Study: MK-8457|MK-8457 100 mg BID + MTX for up to 76 weeks in the Extension Study. Participants who completed or had early escape from the Base Study were eligible to enroll in the Extension Study
739996|NCT01651936|E2|Reported Event|Base Study: Placebo|Placebo BID + MTX for up to 24 weeks in the Base Study
739997|NCT01651936|E1|Reported Event|Base Study: MK-8457|MK-8457 100 mg BID + MTX for up to 24 weeks in the Base Study
739998|NCT01651780|B3|Baseline|Total|Total of all reporting groups
739999|NCT01651780|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740000|NCT01651780|B1|Baseline|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740001|NCT01651780|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An activated clotting time (ACT) target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740002|NCT01651780|P1|Participant Flow|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during transcatheter aortic valve replacement (TAVR). It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740003|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740049|NCT01651351|E2|Reported Event|GLASSIA Infusion Rate- 0.2 mL/kg/Min|"Participants who received simultaneous infusions of:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min"
740050|NCT01651351|E1|Reported Event|GLASSIA Infusion Rate- 0.04 mL/kg/Min|"Participants who received simultaneous infusions of:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min"
740073|NCT01651104|E1|Reported Event|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
740004|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740005|NCT01651780|O4|Outcome|UFH: Second Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
740006|NCT01651780|O3|Outcome|UFH: First Half of Study Site's Enrolled Participants|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
740007|NCT01651780|O2|Outcome|Bivalirudin: Second Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the second half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
740008|NCT01651780|O1|Outcome|Bivalirudin: First Half of Study Site's Enrolled Participants|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline. This includes the first half of the site’s enrolled participants, and only sites with more than 20 participants are included in this analysis.
740009|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740112|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
740010|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740011|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740012|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740013|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740014|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740015|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740016|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740017|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740018|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740019|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740071|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
740072|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
740020|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740021|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740022|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740023|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740024|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740025|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740026|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740027|NCT01651780|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740113|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
743307|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
740028|NCT01651780|O1|Outcome|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740029|NCT01651780|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH adhered to the standard institutional practice. An ACT target ≥250 seconds was recommended. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740030|NCT01651780|E1|Reported Event|Bivalirudin|Bivalirudin administered as a bolus and intravenous (IV) infusion during TAVR. It was recommended that the bolus (0.75 milligrams per kilogram [mg/kg]) be directly administered through the valve delivery sheath immediately following its successful delivery via percutaneous femoral access. Systemic IV administration of the bolus dose was also acceptable. The bivalirudin IV infusion was initiated immediately after the bolus administration. All wires, catheters, and sheaths were to be flushed with heparinized saline.
740031|NCT01651351|B3|Baseline|Total|Total of all reporting groups
740032|NCT01651351|B2|Baseline|Cohort 2|"Day 1:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Day 15:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Placebo: Human albumin 2.5%: Intravenous administration"
740033|NCT01651351|B1|Baseline|Cohort 1|"Day 1:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Day 15:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Placebo: Human albumin 2.5%: Intravenous administration"
740034|NCT01651351|P2|Participant Flow|Cohort 2|"Day 1:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Day 15:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.~Placebo: Human albumin 2.5%: Intravenous administration"
740035|NCT01651351|P1|Participant Flow|Cohort 1|"Day 1:~GLASSIA at 0.04 mL/kg/min~Placebo at 0.2 mL/kg/min~Day 15:~GLASSIA at 0.2 mL/kg/min~Placebo at 0.04 mL/kg/min~Alpha1-proteinase inhibitor: GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.~Placebo: Human albumin 2.5%: Intravenous administration"
740036|NCT01651351|O1|Outcome|All Study Participants|
740037|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
740038|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
740039|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
740040|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
740041|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
740042|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
740043|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
740044|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
740045|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
740046|NCT01651351|O1|Outcome|GLASSIA at 0.04 mL/kg/Min + Placebo at 0.2 mL/kg/Min|
740047|NCT01651351|O2|Outcome|GLASSIA at 0.2 mL/kg/Min + Placebo at 0.04 mL/kg/Min|
740074|NCT01651000|B3|Baseline|Total|Total of all reporting groups
740051|NCT01651260|B1|Baseline|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
740052|NCT01651260|P1|Participant Flow|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
740053|NCT01651260|O1|Outcome|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
740054|NCT01651260|O1|Outcome|Hollister Endotracheal (ET) Tube Securement Device|Hollister endotracheal tube securement device : Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
740055|NCT01651260|E1|Reported Event|Hollister ET Tube Securement Device|Hollister endotracheal tube securement device: Subjects wear one Hollister ET tube securement device until the device either needs to be changed or is no longer required by the subject.
740056|NCT01651208|B3|Baseline|Total|Total of all reporting groups
740057|NCT01651208|B2|Baseline|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
740058|NCT01651208|B1|Baseline|Motivational Interviewing (MINT)|The MINT intervention will consist of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Contentedness, Self-Efficacy theory, and the Stages of Change model.
740059|NCT01651208|P2|Participant Flow|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
740080|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740060|NCT01651208|P1|Participant Flow|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
740061|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
740062|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
740063|NCT01651208|O2|Outcome|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
740064|NCT01651208|O1|Outcome|Motivational Interviewing (MINT)|The MINT intervention consists of quarterly telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. Each call would last approximately 30 minutes. .MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.
740065|NCT01651208|E2|Reported Event|Mailed DVD|A DVD that re-enforces an adequate behavior regarding adherence to anti-platelet will be compared to a MINT intervention. The DVD will also address many questions and concerns patients have after stent placement. The intervention is based on role theory and the effects of vicarious learning via electronic media with respect to Cardiovascular behaviors.
740066|NCT01651208|E1|Reported Event|Motivational Interviewing (MINT)|"The MINT intervention will consist of 4 to 7 telephone encounters between a nurse trained in Motivational interviewing and a minority subject who recently received a coronary stent. All subjects in the MINT arm will be contacted every 3 months to complete 4 encounters.MINT is a well-known, scientifically tested behavioral counseling strategy developed as an amalgamation of principles drawn from several theoretical paradigms, the most important of which are Self-Determination Theory, Patient-Centeredness, Self-Efficacy theory, and the Stages of Change model.~Motivational Interviewing (MINT): Each telephone encounter will have a patient centered approach having the following basic structure"
740067|NCT01651104|B1|Baseline|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
740068|NCT01651104|P1|Participant Flow|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
740069|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
740070|NCT01651104|O1|Outcome|≥65 Y|Subjects ≥65 years of age who received one aTIV vaccination
754226|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
740075|NCT01651000|B2|Baseline|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740076|NCT01651000|B1|Baseline|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740077|NCT01651000|P2|Participant Flow|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740078|NCT01651000|P1|Participant Flow|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740079|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740111|NCT01650779|P1|Participant Flow|Agalsidase Beta|Commercially available agalsidase beta (Fabrazyme ®) 1.0 milligram per kilogram (mg/kg) administered as an intravenous infusion every 2 weeks (q2w) up to Month 6.
740081|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740082|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740083|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740084|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740085|NCT01651000|O2|Outcome|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740086|NCT01651000|O1|Outcome|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740087|NCT01651000|E2|Reported Event|CTAP101 30 μg Capsules|"1 CTAP101 30 μg capsule daily at bedtime for 12 weeks, with a possible increase in a blinded fashion to 2 CTAP101 30 μg capsules daily at bedtime for study duration, if needed (26 weeks total). Subjects not requiring a dose increase after 12 weeks would receive 1 CTAP101 30 μg capsule and one sugar pill (to CTAP101 30 μg capsule) for weeks 13-26.~CTAP101 30 μg capsules: CTAP101 30 μg capsule taken daily at bedtime.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740088|NCT01651000|E1|Reported Event|Sugar Pill to CTAP101 30 μg Capsule|"1 sugar pill to CTAP101 30 μg capsule daily at bedtime for 12 weeks, with an increase to 2 sugar pills to CTAP101 30 μg capsules daily at bedtime for weeks 13-26.~Sugar pill to CTAP101 30 μg capsules: Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime."
740089|NCT01650831|B1|Baseline|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
740090|NCT01650831|P1|Participant Flow|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
740091|NCT01650831|O2|Outcome|Negative Modified BreathID|The amount of subjects that produced negative results for H.pylori with modified BreathID.
740092|NCT01650831|O1|Outcome|Positive Modified BreathID|The amount of subjects that produced positive results for H.pylori with modified BreathID.
740093|NCT01650831|O2|Outcome|Marketed BreathID Negative|Cleared BreathID subjects that were found to be negative for H.pylori
740094|NCT01650831|O1|Outcome|Marketed BreathID Positive|Cleared BreathID subjects that were found to be positive for H.pylori
740095|NCT01650831|O1|Outcome|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
740096|NCT01650831|E1|Reported Event|Clinical Suspicion of Hpylori|"All subjects arriving at clinic with suspicion of having Helicobacter infection due to symptoms such as reflux, ulcer, gastric cancer and other clinical gastric conditions~Modified BreathID : A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula"
740097|NCT01650805|B3|Baseline|Total|Total of all reporting groups
740098|NCT01650805|B2|Baseline|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
740099|NCT01650805|B1|Baseline|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
740100|NCT01650805|P2|Participant Flow|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
740101|NCT01650805|P1|Participant Flow|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
740102|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
740103|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
740104|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
740105|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
740106|NCT01650805|O2|Outcome|Imatinib|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
740107|NCT01650805|O1|Outcome|Ponatinib|ponatinib: 45 mg tablet, taken orally once daily
740108|NCT01650805|E2|Reported Event|Imatinib 400 mg|imatinib (Gleevec/ Glivec): 400 mg tablet, taken orally once daily
740109|NCT01650805|E1|Reported Event|Ponatinib 45 mg|ponatinib: 45 mg tablet, taken orally once daily
740110|NCT01650779|B1|Baseline|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
740114|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
740115|NCT01650779|O1|Outcome|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
740116|NCT01650779|E1|Reported Event|Agalsidase Beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion every 2 weeks up to Month 6.
740117|NCT01650519|B3|Baseline|Total|Total of all reporting groups
740118|NCT01650519|B2|Baseline|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740119|NCT01650519|B1|Baseline|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740120|NCT01650519|P2|Participant Flow|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740121|NCT01650519|P1|Participant Flow|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740122|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740123|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740124|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740125|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740126|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740160|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740161|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
754227|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
740127|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740128|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740129|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740130|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740131|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740132|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740133|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
745875|NCT01627002|E3|Reported Event|Part A PA401 1.0 mg|
740134|NCT01650519|O2|Outcome|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740135|NCT01650519|O1|Outcome|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740136|NCT01650519|E2|Reported Event|IV Ketorolac|"Either 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia. 800 mg NS administered intravenously over 10 minutes at hour 0 and hour 4.~IV ketorolac: 30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds"
740137|NCT01650519|E1|Reported Event|IV Ibuprofen|"800 mg intravenous ibuprofen administered intravenously over 10 minutes at hour 0 and again at hour 4. 30 mg NS < 65 years of age (15 mg NS for patients > 65 years of age) administered intravenously over no less than 15 seconds at reversal of anesthesia.~IV ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 10 minutes."
740138|NCT01650350|B1|Baseline|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
740139|NCT01650350|P1|Participant Flow|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
740140|NCT01650350|O1|Outcome|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
740141|NCT01650350|E1|Reported Event|Low Dose Naltrexone|"LDN, 5 mg/day-(1 cycle = 28 days).~Naltrexone"
740142|NCT01650324|B6|Baseline|Total|Total of all reporting groups
740143|NCT01650324|B5|Baseline|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740144|NCT01650324|B4|Baseline|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740145|NCT01650324|B3|Baseline|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740146|NCT01650324|B2|Baseline|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
740147|NCT01650324|B1|Baseline|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
740148|NCT01650324|P5|Participant Flow|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740149|NCT01650324|P4|Participant Flow|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740150|NCT01650324|P3|Participant Flow|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740151|NCT01650324|P2|Participant Flow|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
740152|NCT01650324|P1|Participant Flow|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
740153|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740154|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740155|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740156|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
740157|NCT01650324|O1|Outcome|Placebo|Participants received a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg or 600 mg.
740158|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740159|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740162|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740163|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740164|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740165|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
740166|NCT01650324|O4|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740167|NCT01650324|O3|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740168|NCT01650324|O2|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740169|NCT01650324|O1|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
740170|NCT01650324|O5|Outcome|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740171|NCT01650324|O4|Outcome|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740172|NCT01650324|O3|Outcome|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740173|NCT01650324|O2|Outcome|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
740174|NCT01650324|O1|Outcome|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
740175|NCT01650324|E5|Reported Event|DBPR108 600 mg|Participants received a single oral dose of DBPR108 600 mg
740176|NCT01650324|E4|Reported Event|DBPR108 300 mg|Participants received a single oral dose of DBPR108 300 mg
740177|NCT01650324|E3|Reported Event|DBPR108 100 mg|Participants received a single oral dose of DBPR108 100 mg
740178|NCT01650324|E2|Reported Event|DBPR108 25 mg|Participants received a single oral dose of DBPR108 25 mg
740179|NCT01650324|E1|Reported Event|Placebo|Participants received either a single oral dose of matching placebo to DBPR108 25 mg, 100 mg, 300 mg, or 600 mg
740180|NCT01650285|B1|Baseline|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
740321|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
740181|NCT01650285|P1|Participant Flow|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
740182|NCT01650285|O1|Outcome|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
740183|NCT01650285|E1|Reported Event|Cabazitaxel and Radiation|"Radiation therapy (RT) will be delivered to 64.8 Gy, using IMRT treatment Cabazitaxel will be administered IV every 21 days for 3 doses at the assigned dose level.~Cabazitaxel: Dose Level Day 1, 22, 43~5.0 mg/m2~10.0 mg/m2~15.0 mg/m2~20.0 mg/m2"
740184|NCT01650246|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
740185|NCT01650246|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
740186|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
740187|NCT01650246|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
740188|NCT01650246|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg once daily (qd)
740189|NCT01649856|B3|Baseline|Total|Total of all reporting groups
740190|NCT01649856|B2|Baseline|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740191|NCT01649856|B1|Baseline|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740192|NCT01649856|P2|Participant Flow|Rituximab Intravenous (IV)|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740193|NCT01649856|P1|Participant Flow|Rituximab Subcutaneous (SC)|Participants with previously untreated, cluster of differentiation (CD) 20-positive diffuse large B-cell lymphoma (DLBCL) received up to 8 cycles of rituximab in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 milligrams per meter-squared (mg/m^2) via IV infusion; subsequent doses were given as 1400 milligrams (mg) via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved complete response (CR) or complete response unconfirmed (CRu) after 4 cycles, but all participants received a full 8 cycles of rituximab.
740230|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740194|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740195|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740196|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740197|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740322|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
740323|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
740198|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740199|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740200|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740201|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740202|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740203|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740231|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740232|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740204|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740205|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740206|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740207|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740208|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
745876|NCT01627002|E2|Reported Event|Part A PA401 0.3 mg|
740209|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740210|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740211|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740212|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740213|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740214|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740215|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740216|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740217|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740218|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740219|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740220|NCT01649856|O2|Outcome|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740221|NCT01649856|O1|Outcome|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740222|NCT01649856|E2|Reported Event|Rituximab IV|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For all cycles, rituximab was administered at a dose of 375 mg/m^2 via IV infusion. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740223|NCT01649856|E1|Reported Event|Rituximab SC|Participants with previously untreated, CD20-positive DLBCL received up to 8 cycles of rituximab in combination with CHOP. Treatment was given on Day 1 of each cycle, and the cycle length (14 or 21 days) was decided by the study center. For Cycle 1, rituximab was administered at a dose of 375 mg/m^2 via IV infusion; subsequent doses were given as 1400 mg via SC injection. Tumor response was assessed after 4 cycles according to criteria published by Cheson et al (1999), which are presented in Outcome Measure 1. The duration of CHOP therapy could be reduced from 8 to 6 cycles for those who achieved CR or CRu after 4 cycles, but all participants received a full 8 cycles of rituximab.
740224|NCT01649804|B1|Baseline|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740225|NCT01649804|P1|Participant Flow|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 milligram/kilogram (mg/kg) intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740226|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740227|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740228|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740229|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
754228|NCT01587079|O8|Outcome|GP MDI 18 μg (PT001)|18 μg
740233|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740234|NCT01649804|O1|Outcome|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740235|NCT01649804|E1|Reported Event|Tocilizumab|Tocilizumab (RoActemra/Actemra) 8 mg/kg intravenously every 4 weeks for 104 weeks. Dose could be reduced due to safety reasons at any time during the study.
740236|NCT01649791|B1|Baseline|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
740237|NCT01649791|P1|Participant Flow|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
740238|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
740239|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
740324|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
740325|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
745877|NCT01627002|E1|Reported Event|Part A PA401 0.1 mg|
740240|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
740241|NCT01649791|O1|Outcome|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
740242|NCT01649791|E1|Reported Event|Treatment (Lenalidomide as Chemoprevention)|"Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~lenalidomide: Given orally~laboratory biomarker analysis: Correlative study~lymph node biopsy: Correlative study~bone marrow aspiration: Correlative study~pharmacological study: Correlative study~flow cytometry: Correlative study"
740243|NCT01649557|B4|Baseline|Total|Total of all reporting groups
740244|NCT01649557|B3|Baseline|Prior Apripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740245|NCT01649557|B2|Baseline|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740246|NCT01649557|B1|Baseline|Prior Brexiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740247|NCT01649557|P3|Participant Flow|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740248|NCT01649557|P2|Participant Flow|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740249|NCT01649557|P1|Participant Flow|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740250|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740251|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740252|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740253|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740254|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740255|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740256|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740257|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740258|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
745878|NCT01626820|B3|Baseline|Total|Total of all reporting groups
740259|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740260|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740261|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740262|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740263|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740264|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740265|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740266|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740267|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740268|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740269|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740296|NCT01649362|P1|Participant Flow|Control Group|no prefeeding oral stimulation
740297|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
740298|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
740270|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740271|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740272|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740273|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740274|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740275|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740276|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740277|NCT01649557|O3|Outcome|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740278|NCT01649557|O2|Outcome|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740279|NCT01649557|O1|Outcome|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740280|NCT01649557|E3|Reported Event|Prior Aripiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior aripiprazole group included the participants who received aripiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740281|NCT01649557|E2|Reported Event|Prior Placebo|The participants were grouped based on the medications that they received prior to the trial. The participants in prior placebo group included the participants who received placebo prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740282|NCT01649557|E1|Reported Event|Prior Brexpiprazole|The participants were grouped based on the medications that they received prior to the trial. The participants in prior brexpiprazole group included the participants who received brexpiprazole prior to the trial. The participants began dosing with brexpiprazole 2 mg daily and the dosage was increased upto 6 mg daily if the dose was well-tolerated.
740283|NCT01649505|B3|Baseline|Total|Total of all reporting groups
740284|NCT01649505|B2|Baseline|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
740285|NCT01649505|B1|Baseline|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
740286|NCT01649505|P2|Participant Flow|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
740287|NCT01649505|P1|Participant Flow|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
740288|NCT01649505|O2|Outcome|Arm II (Standard Electrocoagulation)|"Patients undergo standard electrocoagulation dissection technique.~breast reconstruction : Undergo electrocoagulation dissection technique"
740289|NCT01649505|O1|Outcome|Arm I (Fibrin Sealant)|"Patients undergo sharp dissection technique with fibrin sealant closure.~breast reconstruction : Undergo sharp dissection technique~fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically"
740290|NCT01649505|E2|Reported Event|Arm II (Standard Electrocoagulation)|Patients undergo standard electrocoagulation dissection technique.
740291|NCT01649505|E1|Reported Event|Arm I (Fibrin Sealant)|Patients undergo sharp dissection technique with fibrin sealant closure.
740292|NCT01649362|B3|Baseline|Total|Total of all reporting groups
740293|NCT01649362|B2|Baseline|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
740294|NCT01649362|B1|Baseline|Control Group|no prefeeding oral stimulation
740295|NCT01649362|P2|Participant Flow|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
740299|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
740300|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
740301|NCT01649362|O2|Outcome|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
740302|NCT01649362|O1|Outcome|Control Group|no prefeeding oral stimulation
740303|NCT01649362|E2|Reported Event|Oral Stimulation|preterm infants receiving an prefeeding oral stimulation program
740304|NCT01649362|E1|Reported Event|Control Group|no prefeeding oral stimulation
740305|NCT01649297|B6|Baseline|Total|Total of all reporting groups
740306|NCT01649297|B5|Baseline|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
740307|NCT01649297|B4|Baseline|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
740308|NCT01649297|B3|Baseline|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
740309|NCT01649297|B2|Baseline|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
740310|NCT01649297|B1|Baseline|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
740311|NCT01649297|P5|Participant Flow|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
740312|NCT01649297|P4|Participant Flow|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
740313|NCT01649297|P3|Participant Flow|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
740314|NCT01649297|P2|Participant Flow|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
740315|NCT01649297|P1|Participant Flow|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
740316|NCT01649297|O5|Outcome|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
740317|NCT01649297|O4|Outcome|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
740318|NCT01649297|O3|Outcome|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
740319|NCT01649297|O2|Outcome|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
740320|NCT01649297|O1|Outcome|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
745969|NCT01626118|P4|Participant Flow|Placebo|Placebo Group
740326|NCT01649297|E5|Reported Event|Placebo|Oral administration of Placebo tablets matching empagliflozin 25 mg, 10 mg, 5 mg, and 2.5 mg
740327|NCT01649297|E4|Reported Event|Empa 10mg QD|Oral administration of Empagliflozin (Empa) 10 mg once daily (QD)
740328|NCT01649297|E3|Reported Event|Empa 5mg BID|Oral administration of Empagliflozin (Empa) 5 mg twice daily (BID)
740329|NCT01649297|E2|Reported Event|Empa 25mg QD|Oral administration of Empagliflozin (Empa) 25 mg once daily (QD)
740330|NCT01649297|E1|Reported Event|Empa 12.5mg BID|Oral administration of Empagliflozin (Empa) 12.5 mg twice daily (BID)
740331|NCT01649232|B3|Baseline|Total|Total of all reporting groups
740332|NCT01649232|B2|Baseline|Controls|Healthy people that not receive tDCS
740333|NCT01649232|B1|Baseline|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740334|NCT01649232|P2|Participant Flow|Controls|Healthy people that not receive tDCS
740335|NCT01649232|P1|Participant Flow|Active tDCS|"Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days.~55 % of subjects led the anode in temporal lobe (60% right temporal lobe and 40% in left temporal lobe). 8 % of subjects led de anode in parietal lobe (80 % in left hemisphere), and the rest of subjets 37 % of them led the anodo in frontal and prefrontal lobe (55 % in right frontal lobe and 45 % in left frontal lobe)."
740336|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
740337|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740338|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
740339|NCT01649232|O3|Outcome|Active tDCS at 3 Months|l Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740340|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
740341|NCT01649232|O1|Outcome|Active tDCS Group|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740342|NCT01649232|O4|Outcome|Control Group at 3 Months|Healthy people that not receive tDCS
740343|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740344|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
740345|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740346|NCT01649232|O4|Outcome|Controls at 3 Months|Healthy people that not receive tDCS
740347|NCT01649232|O3|Outcome|Active tDCS at 3 Months|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740348|NCT01649232|O2|Outcome|Controls|Healthy people that not receive tDCS
740349|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740350|NCT01649232|O2|Outcome|Control Group|Healthy people that not receive tDCS
740351|NCT01649232|O1|Outcome|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740352|NCT01649232|E2|Reported Event|Controls|Healthy people that not receive tDCS
740353|NCT01649232|E1|Reported Event|Active tDCS|Transcranial Direct-Current Stimulation. Patients with ADHD that receive electro-stimulation 20 sessions with 2 mAmp 1 session per day alternative days
740354|NCT01649180|B1|Baseline|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740355|NCT01649180|P1|Participant Flow|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740356|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740357|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740358|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740359|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740360|NCT01649180|O1|Outcome|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740361|NCT01649180|E1|Reported Event|Axitinib|"Axitinib will be given orally and will continue until progression of disease.~Axitinib: Axitinib 5 mg orally with food every 12 hours. One cycle=28 days."
740362|NCT01648920|B1|Baseline|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740363|NCT01648920|P1|Participant Flow|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740364|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740365|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740366|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740367|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740368|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740369|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740370|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
754229|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
740371|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740372|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740373|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740374|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740387|NCT01648790|P5|Participant Flow|Sequence 5|Day 1= 5 mg test ODT2, T-Fast; Day 2= 5 mg test ODT2, W-Fast; Day 3= 5 mg test ODT2, T-Fed; Day 4= 2 mg test ODT2, T-Fast; Day 5= 5 mg ODT1, T-Fast
740388|NCT01648790|P4|Participant Flow|Sequence 4|Day 1= 5 mg test ODT2, W-Fast; Day 2= 5 mg test ODT2, T-Fed; Day 3= 2 mg test ODT2, T-Fast; Day 4= 5 mg ODT1,T-Fast; Day 5= 5 mg test ODT2, T-Fast
746210|NCT01624350|O2|Outcome|Permacol Collagen Paste - 1 Month Post-op|
740375|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740376|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740377|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740378|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740379|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740380|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740381|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740382|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740383|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740384|NCT01648920|O1|Outcome|FeNO|"Participants with suspected but undiagnosed asthma will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they will have a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740385|NCT01648920|E1|Reported Event|FeNO|"Participants with suspected but undiagnosed asthma had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit. Following that they had a Methacholine Challenge (MCC) test performed according to the ATS guidelines and the Allergy and Asthma Specialists Procedure for conducting MCC tests~NIOX MINO® Instrument (09-1100): The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate."
740386|NCT01648790|B1|Baseline|All Participants|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® formulation (ODT1) or orally disintegrating tablet containing Magnasweet® formulation (ODT2) given either on top of tongue or dispersed in water administered in either the fasted or fed state. 2 mg prasugrel ODT2 given on top of tongue in the fasted state.
743308|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
740389|NCT01648790|P3|Participant Flow|Sequence 3|Day 1= 5 mg test ODT2, T-Fed; Day 2= 2 mg test ODT2, T-Fast; Day 3= 5 mg ODT1, T-Fast; Day 4= 5 mg test ODT2, T-Fast; Day 5= 5 mg test ODT2, W-Fast
740390|NCT01648790|P2|Participant Flow|Sequence 2|Day 1= 2 mg test ODT2, T-Fast; Day 2= 5 mg ODT1, T-Fast; Day 3= 5 mg test ODT2, T-Fast; Day 4= 5 mg test ODT2, W-Fast; Day 5= 5 mg test ODT2, T-Fed
740391|NCT01648790|P1|Participant Flow|Sequence 1|Day 1= 5 milligrams (mg) prasugrel without Magnasweet (reference) orally disintegrating tablet (ODT1), given on top of tongue in fasted state (T-Fast); Day 2= 5 mg prasugrel with Magnasweet (test) orally disintegrating tablet (ODT2),T-Fast; Day 3= 5 mg test ODT2, given dispersed in water in fasted state (W-Fast); Day 4= 5 mg test ODT2, given on top of tongue in fed state (T-Fed); Day 5= 2 mg test ODT2, T-Fast
740392|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
740393|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
740394|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
740395|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
740396|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
740397|NCT01648790|O5|Outcome|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
740398|NCT01648790|O4|Outcome|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
740399|NCT01648790|O3|Outcome|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
740400|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
740401|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
740402|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
740403|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
740404|NCT01648790|O2|Outcome|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
740405|NCT01648790|O1|Outcome|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
740406|NCT01648790|E5|Reported Event|2 mg Prasugrel (ODT2)|2 mg Prasugrel as ODT2 formulation administered orally once in the fasted state.
740407|NCT01648790|E4|Reported Event|5 mg Prasugrel (ODT2)-Fed|5 mg Prasugrel as ODT2 formulation administered orally once, following a standardized breakfast.
740408|NCT01648790|E3|Reported Event|5 mg Prasugrel (ODT2)-Suspension|5 mg Prasugrel as ODT2 formulation dispersed in water administered once, orally as suspension, in the fasted state.
740409|NCT01648790|E2|Reported Event|5 mg Prasugrel (ODT2)|5 mg Prasugrel as orally disintegrating tablet containing Magnasweet® (ODT2) formulation administered orally once in the fasted state.
740410|NCT01648790|E1|Reported Event|5 mg Prasugrel (ODT1)|5 mg Prasugrel as orally disintegrating tablet without Magnasweet® (ODT1) formulation administered orally once in the fasted state.
740411|NCT01648699|B1|Baseline|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
740412|NCT01648699|P1|Participant Flow|Osmotic Release Oral System (OROS) Hydromorphone|Osmotic Release Oral System (OROS) Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 milligram (mg) oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
740413|NCT01648699|O1|Outcome|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
740414|NCT01648699|O8|Outcome|OROS Hydromorphone (No Dose Indicated)|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning for 28 days, as the dose was not indicated for these participants.
740415|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740416|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740469|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
746211|NCT01624350|O1|Outcome|Baseline|
740417|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740418|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740419|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740420|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740421|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740422|NCT01648699|O7|Outcome|OROS Hydromorphone 40 mg|OROS Hydromorphone was administered as 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740423|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740424|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740425|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740426|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740460|NCT01647464|P1|Participant Flow|Contrast Administration|Patients undergoing contrast-enhanced echo.
740427|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740428|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740429|NCT01648699|O7|Outcome|OROS Hydromorphone 36 mg|OROS Hydromorphone was administered as 36 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740430|NCT01648699|O6|Outcome|OROS Hydromorphone 32 mg|OROS Hydromorphone was administered as 32 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740431|NCT01648699|O5|Outcome|OROS Hydromorphone 24 mg|OROS Hydromorphone was administered as 24 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740432|NCT01648699|O4|Outcome|OROS Hydromorphone 20 mg|OROS Hydromorphone was administered as 20 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740433|NCT01648699|O3|Outcome|OROS Hydromorphone 16 mg|OROS Hydromorphone was administered as 16 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740809|NCT01647945|P1|Participant Flow|Placebo|Placebo: placebo pill
746212|NCT01624350|O2|Outcome|Last Visit|
740434|NCT01648699|O2|Outcome|OROS Hydromorphone 12 mg|OROS Hydromorphone was administered as 12 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740435|NCT01648699|O1|Outcome|OROS Hydromorphone 8 Milligram (mg)|OROS Hydromorphone was administered as 8 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days. The study drug was administered up to 28 days.
740436|NCT01648699|E1|Reported Event|OROS Hydromorphone|OROS Hydromorphone was administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) was converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and was increased if needed, but not more frequently than every two days and not more than 40 mg. The study drug was administered up to 28 days.
740437|NCT01647542|B4|Baseline|Total|Total of all reporting groups
740438|NCT01647542|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
740439|NCT01647542|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
740440|NCT01647542|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
740441|NCT01647542|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
740442|NCT01647542|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
740443|NCT01647542|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
740444|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
740445|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
740446|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
740447|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
740448|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
740449|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
740450|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
740451|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
740452|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
740453|NCT01647542|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
740454|NCT01647542|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
740455|NCT01647542|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
740456|NCT01647542|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily, for up to 24 weeks.
740457|NCT01647542|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily, for up to 24 weeks.
740458|NCT01647542|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily, for up to 24 weeks.
740459|NCT01647464|B1|Baseline|Contrast Administration|Patients undergoing contrast-enhanced echo.
740461|NCT01647464|O1|Outcome|Contrast Administration|Patients undergoing contrast-enhanced echo.
740462|NCT01647464|E1|Reported Event|Contrast Administration|Patients undergoing contrast-enhanced echo.
740463|NCT01647438|B3|Baseline|Total|Total of all reporting groups
740464|NCT01647438|B2|Baseline|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
740465|NCT01647438|B1|Baseline|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
740466|NCT01647438|P2|Participant Flow|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
740467|NCT01647438|P1|Participant Flow|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
740468|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
746213|NCT01624350|O1|Outcome|First Visit|
740470|NCT01647438|O2|Outcome|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
740471|NCT01647438|O1|Outcome|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
740472|NCT01647438|E2|Reported Event|Lifestyle Intervention|Lifestyle Intervention: Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
740473|NCT01647438|E1|Reported Event|Primary Care Referral and Print Health Education|Primary Care Referral and Print Health Education: Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
740474|NCT01648582|B4|Baseline|Total|Total of all reporting groups
740475|NCT01648582|B3|Baseline|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740476|NCT01648582|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740477|NCT01648582|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740478|NCT01648582|P3|Participant Flow|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
740479|NCT01648582|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740480|NCT01648582|P1|Participant Flow|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 subcutaneous (SC) injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740481|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740482|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740483|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740484|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
741434|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
740485|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740486|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740487|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740488|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740489|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740490|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740491|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740492|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740493|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740494|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740495|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740496|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740497|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740498|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
743309|NCT01640353|E1|Reported Event|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
740499|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740500|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740501|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740502|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740503|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740504|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740505|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740506|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740507|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740508|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740509|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740510|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740511|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
740512|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740513|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740514|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740515|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740516|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740517|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
743090|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
740518|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740519|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740520|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740521|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740522|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740523|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
740524|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740525|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740526|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740527|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740528|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740529|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740530|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
740531|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740532|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740533|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
740534|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740535|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740536|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
740537|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740538|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740539|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
740540|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740541|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740542|NCT01648582|O3|Outcome|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and/or a sulfonylurea.
740543|NCT01648582|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740544|NCT01648582|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740545|NCT01648582|E3|Reported Event|Insulin Glargine|Insulin glargine administered per dosing titration schedule as once daily SC injection at bedtime added to participant’s pre-study prescribed dose of metformin and /or a sulfonylurea.
740546|NCT01648582|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740547|NCT01648582|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as 1 SC injection once-weekly added to participant's pre-study prescribed dose of metformin and/or a sulfonylurea.
740548|NCT01648530|B1|Baseline|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
740549|NCT01648530|P1|Participant Flow|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
740550|NCT01648530|O2|Outcome|Participants With Chronic Migraine|Participants who returned completed internet survey with Chronic Migraine defined as ≥15 headache days/month. No intervention was administered in this study.
740551|NCT01648530|O1|Outcome|Participants With Episodic Migraine|Participants who returned completed internet survey with Episodic Migraine defined as <15 headache days/month. No intervention was administered in this study.
740552|NCT01648530|O1|Outcome|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
740553|NCT01648530|E1|Reported Event|Participants With Migraines|Participants who returned completed internet survey with positive screening for migraines. No intervention was administered in this study.
740554|NCT01648491|B1|Baseline|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
740555|NCT01648491|P1|Participant Flow|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
740556|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
740557|NCT01648491|O1|Outcome|Stem Cell Treatment|Muscle biopsy and injection of autologous stem cells. Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core. Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the urethra.
740558|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
740559|NCT01648491|O1|Outcome|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
740560|NCT01648491|E1|Reported Event|Stem Cell Treatment|"Muscle Biopsy and Injection of autologous stem cells~Muscle Biopsy: Biopsy of thigh muscle to obtain stem cell core.~Injection of autologous stem cells: After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra."
740561|NCT01648452|B1|Baseline|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740562|NCT01648452|P1|Participant Flow|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740563|NCT01648452|O1|Outcome|Untreated Control Eye|
743310|NCT01640340|B3|Baseline|Total|Total of all reporting groups
740564|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740565|NCT01648452|O1|Outcome|Untreated Control Eye|
740566|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740567|NCT01648452|O1|Outcome|Untreated Control Eye|
740568|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740569|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740570|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740571|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740572|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740573|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740574|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740575|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740576|NCT01648452|O1|Outcome|NT-501 CNTF-releasing Implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline.
740577|NCT01648452|E2|Reported Event|NT-501 CNTF-releasing Implant Events > 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed are adverse events reported after the primary outcome endpoint of 6 months post-implantation.
740578|NCT01648452|E1|Reported Event|NT-501 CNTF-releasing Implant Events ≤ 6 Months Post-implant|Participants received an ocular implantation of a NT-501 CNTF-releasing capsule (20 ng/day) in one eye (the study eye) at baseline. The events listed reflect the primary outcome endpoint of adverse events reported within 6 months post-implantation.
740579|NCT01648140|B5|Baseline|Total|Total of all reporting groups
740580|NCT01648140|B4|Baseline|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740858|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740859|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740581|NCT01648140|B3|Baseline|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740582|NCT01648140|B2|Baseline|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740583|NCT01648140|B1|Baseline|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740584|NCT01648140|P4|Participant Flow|GSK2336805 60 mg, G4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740585|NCT01648140|P3|Participant Flow|Telaprevir, G1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740586|NCT01648140|P2|Participant Flow|GSK2336805 60 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740810|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
740587|NCT01648140|P1|Participant Flow|GSK2336805 40 mg, G1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (Pegylated Interferon Alfa-2a [PEG] + Ribavirin [RIBA]) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the extended rapid virologic response (eRVR) achievement. PEG dose was 180 micrograms (µg) once weekly subcutaneous (SC) injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kilogram [kg]) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740588|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740589|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740590|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740591|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740592|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740860|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
754230|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
740593|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740594|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740595|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740596|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740597|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740598|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740811|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
740812|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
740813|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
746214|NCT01624350|O3|Outcome|Permacol Collagen Paste - 12 Month Post-op|
740599|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740600|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740601|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740602|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740603|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740604|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
743091|NCT01641653|O2|Outcome|Midazolam|One half of subjects will recieveMidazolam: 1-2.5 mg IV
740605|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740606|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740607|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740608|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740609|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740610|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740814|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
740815|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
740816|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
740817|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
740611|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740612|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740613|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740614|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740615|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740616|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740617|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740618|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740619|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740620|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740621|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740622|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740818|NCT01647945|O4|Outcome|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
740819|NCT01647945|O3|Outcome|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
740820|NCT01647945|O2|Outcome|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
740821|NCT01647945|O1|Outcome|Placebo|Placebo: placebo pill
740623|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740624|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740625|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740626|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740627|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740628|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740629|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740630|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2 divided doses with food.
740631|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740632|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740633|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740634|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740822|NCT01647945|E4|Reported Event|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
740823|NCT01647945|E3|Reported Event|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
740824|NCT01647945|E2|Reported Event|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
740825|NCT01647945|E1|Reported Event|Placebo|Placebo: placebo pill
740635|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740636|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740637|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740638|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740639|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740640|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740641|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740642|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740643|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740644|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740645|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740646|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740826|NCT01647737|B3|Baseline|Total|Total of all reporting groups
740827|NCT01647737|B2|Baseline|Placebo|"Xylitol~Green tea lozenge: 4-6 times daily"
740828|NCT01647737|B1|Baseline|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
740829|NCT01647737|P2|Participant Flow|Placebo|Xylitol lozenge 4 - 6 times daily
740830|NCT01647737|P1|Participant Flow|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
740647|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740648|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740649|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740650|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740651|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740652|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740653|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740654|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740655|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740656|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
740657|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740658|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
740659|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740660|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
740661|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740662|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken orally in 2divided doses with food.
740663|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 ug once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight is <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight is >=75 kg) taken in 2 divided doses with food.
740664|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeksfollowed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 μg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
740665|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740666|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 and Genotype 4 HCV|Participants with chronic G1 and G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if bodyweight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2divided doses with food.
740667|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740668|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740669|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740670|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740671|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740672|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740673|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740674|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740675|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740676|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740677|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740861|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740862|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740863|NCT01647711|E6|Reported Event|All Participants|All treated participants included in the study.
740678|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740679|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740680|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740681|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740682|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740683|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740684|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740831|NCT01647737|O2|Outcome|Placebo|Xylitol lozenge 4 - 6 times daily
740832|NCT01647737|O1|Outcome|Green Tea Lozenge|"GTP~Green tea lozenge: 4-6 times daily"
740833|NCT01647737|E2|Reported Event|Xylitol|"4-6 times daily lozenge containing jaborandi extract, and 500 mg xylitol for 8 weeks~Xylitol: 4-6 times daily"
740834|NCT01647737|E1|Reported Event|MighTeaFlow|"4-6 times daily lozenge containing green tea, jaborandi extracts, and 500 mg xylitol for 8 weeks~MighTeaFlow: 4-6 times daily"
740685|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740686|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740687|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740688|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740689|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740690|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740691|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740692|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740693|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740694|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740695|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740696|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740835|NCT01647711|B6|Baseline|Total|Total of all reporting groups
740836|NCT01647711|B5|Baseline|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740837|NCT01647711|B4|Baseline|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740697|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740698|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740699|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740700|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740701|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740702|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740703|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740704|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740705|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740706|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740707|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740708|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740838|NCT01647711|B3|Baseline|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740839|NCT01647711|B2|Baseline|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
743347|NCT01640314|B2|Baseline|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
740709|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740710|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) OD in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740711|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740712|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740713|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740714|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740715|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740716|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740717|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740718|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740719|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740720|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740840|NCT01647711|B1|Baseline|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740841|NCT01647711|P5|Participant Flow|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
743547|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
740721|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740722|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740723|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740724|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740725|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740726|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740727|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740728|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740729|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740730|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740731|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740732|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740842|NCT01647711|P4|Participant Flow|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740843|NCT01647711|P3|Participant Flow|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
743548|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
740733|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740734|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740735|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740736|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740737|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740738|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740739|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740740|NCT01648140|O4|Outcome|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740741|NCT01648140|O3|Outcome|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740742|NCT01648140|O2|Outcome|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740743|NCT01648140|O1|Outcome|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740744|NCT01648140|E4|Reported Event|GSK2336805 60 mg, Genotype 4 HCV|Participants with chronic G4 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740844|NCT01647711|P2|Participant Flow|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740845|NCT01647711|P1|Participant Flow|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
746215|NCT01624350|O2|Outcome|Permacol Collagen Paste - 6 Month Post-op|
740745|NCT01648140|E3|Reported Event|Telaprevir, Genotype 1 HCV|Participants with chronic G1 HCV infection received two telaprevir 375 mg tablets orally 3 times a day (7 to 9 hours apart) with food containing approximately 20 grams of fat in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740746|NCT01648140|E2|Reported Event|GSK2336805 60 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 60 mg orally (30 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG+RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken orally in 2 divided doses with food.
740747|NCT01648140|E1|Reported Event|GSK2336805 40 mg, Genotype 1 HCV|Participants with chronic G1 HCV infection received GSK2336805 40 mg orally (20 mg x 2 tablets) once daily in the morning with food in combination with antiviral therapy (PEG + RIBA) for 12 weeks followed by PEG and RIBA alone for either 12 or 36 weeks based on the eRVR achievement. PEG dose was 180 µg once weekly SC injection and the RIBA dose was 1000 mg orally (200 mg x 5 capsules) (if body weight was <75 kg) or 1200 mg orally (200 mg x 6 capsules) (if body weight was >=75 kg) taken in 2 divided doses with food.
740748|NCT01648101|B4|Baseline|Total|Total of all reporting groups
740749|NCT01648101|B3|Baseline|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740908|NCT01646814|E1|Reported Event|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
740750|NCT01648101|B2|Baseline|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740751|NCT01648101|B1|Baseline|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740752|NCT01648101|P3|Participant Flow|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740753|NCT01648101|P2|Participant Flow|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740754|NCT01648101|P1|Participant Flow|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740755|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
746216|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Post-op|
740756|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740757|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740758|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740864|NCT01647711|E5|Reported Event|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740909|NCT01646671|B4|Baseline|Total|Total of all reporting groups
740759|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740760|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740761|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740762|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740763|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740764|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740846|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
743549|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
740765|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740766|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740767|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740768|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740769|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740770|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740771|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740772|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740773|NCT01648101|O4|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740847|NCT01647711|O1|Outcome|Afatinib|Patients receiving oral administration of afatinib film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
743550|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
740774|NCT01648101|O3|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740775|NCT01648101|O2|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740776|NCT01648101|O1|Outcome|Overall Study Arm|
740865|NCT01647711|E4|Reported Event|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740866|NCT01647711|E3|Reported Event|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740867|NCT01647711|E2|Reported Event|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740777|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740778|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740779|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740780|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740781|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740782|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740783|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740848|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740784|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740785|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
754231|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
740786|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740787|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740788|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740789|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740790|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740791|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740792|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740849|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
746217|NCT01624350|O4|Outcome|Permacol Collagen Paste - 12 Month Post-op|
740793|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740794|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740795|NCT01648101|O3|Outcome|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740796|NCT01648101|O2|Outcome|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740797|NCT01648101|O1|Outcome|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740798|NCT01648101|E3|Reported Event|Placebo|Participants entered a 16-week Treatment Phase (TrP) consisting of a 4-week Titration Phase (TiP) and a 12-week Maintenance Phase (MP). In the TiP, participants received matching placebo in increasing doses. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the Taper/Follow-up Phase (TaP/FUP). Participants who tolerated titration entered the MP and continued to receive the same dose regimen for 12 weeks. After completing the MP, participants who opted to enroll in the open-label extension (OLE) study entered the 4-week Transition Phase (TnP). In the TnP, participants received active retigabine in increasing doses starting at 300 milligrams per day (mg/day), 450 mg/day, 600 mg/day, and 750 mg/day, respectively, in each of 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740799|NCT01648101|E2|Reported Event|Retigabine 600 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of retigabine (RTG) 300 mg/day that increased by 150 mg/day per week until a target dose of 600 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 600 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 600 mg/day for 3 weeks and RTG 750 mg/day in the last week. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740800|NCT01648101|E1|Reported Event|Retigabine 900 mg/Day|Participants entered a 16-week TrP consisting of a 4-week TiP and a 12-week MP. In the TiP, participants received a starting dose of RTG 300 mg/day that increased by 150 mg/day per week until a target dose of 900 mg/day was reached. Participants that could not tolerate the titration or withdrew were discontinued from the study and entered the TaP/FUP. Participants who tolerated titration entered the MP and continued to receive 900 mg/day for 12 weeks. After completing the MP, participants who opted to enroll in the OLE study entered the 4-week TnP. In the TnP, participants received RTG 900 mg/day for 4 weeks. Participants that did not enroll in the OLE study completed a 3-week TaP and 1 week of FUP.
740801|NCT01647945|B5|Baseline|Total|Total of all reporting groups
740802|NCT01647945|B4|Baseline|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
740803|NCT01647945|B3|Baseline|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
740804|NCT01647945|B2|Baseline|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
740805|NCT01647945|B1|Baseline|Placebo|Placebo: placebo pill
740806|NCT01647945|P4|Participant Flow|FK506 Level 3-5|FK506 level 3-5 ng/ml: FK506 goal trough blood level 3-5 ng/ml
740807|NCT01647945|P3|Participant Flow|FK506 Level 2-3|FK506 level 2-3 ng/ml: FK506 goal trough blood level 2-3 ng/ml
740808|NCT01647945|P2|Participant Flow|FK506 Level < 2|FK506 level < 2 ng/ml: FK506 goal trough blood level < 2 ng/ml
740850|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740851|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740852|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740853|NCT01647711|O5|Outcome|Afatinib 200mg|Patients received oral administration of afatinib 200mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740854|NCT01647711|O4|Outcome|Afatinib 160mg|Patients received oral administration of afatinib 160mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740855|NCT01647711|O3|Outcome|Afatinib 150mg|Patients received oral administration of afatinib 150mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740856|NCT01647711|O2|Outcome|Afatinib 120mg|Patients received oral administration of afatinib 120mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740857|NCT01647711|O1|Outcome|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740868|NCT01647711|E1|Reported Event|Afatinib 90mg|Patients received oral administration of afatinib 90mg film-coated tablet once daily for three days, repeated every 14 days, during each 28-day cycle.
740869|NCT01646827|B3|Baseline|Total|Total of all reporting groups
740870|NCT01646827|B2|Baseline|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740871|NCT01646827|B1|Baseline|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740872|NCT01646827|P2|Participant Flow|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740873|NCT01646827|P1|Participant Flow|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740874|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740875|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740876|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740877|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740878|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740879|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740880|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740881|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740882|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740883|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740884|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740885|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740886|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
743551|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
740887|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740888|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740889|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740890|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740891|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740892|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740893|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740894|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740895|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740896|NCT01646827|O2|Outcome|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740897|NCT01646827|O1|Outcome|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single dose of aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740898|NCT01646827|E2|Reported Event|Aripiprazole IM Depot 400 mg: Gluteal|The participants in this group received single aripiprazole IM depot (400 mg) injection in the gluteal muscle.
740899|NCT01646827|E1|Reported Event|Aripiprazole IM Depot 400 mg: Deltoid|The participants in this group received single aripiprazole IM depot (400 mg) injection in the deltoid muscle.
740900|NCT01646814|B3|Baseline|Total|Total of all reporting groups
740901|NCT01646814|B2|Baseline|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
740902|NCT01646814|B1|Baseline|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
740903|NCT01646814|P2|Participant Flow|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
740904|NCT01646814|P1|Participant Flow|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
740905|NCT01646814|O2|Outcome|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
740906|NCT01646814|O1|Outcome|PL2200|"Investigational product, PL2200~PL2200: PL2200, containing 325 mg aspirin active ingredient"
740907|NCT01646814|E2|Reported Event|Aspirin Tablets|"Active comparator, 325 mg aspirin tablets~Aspirin tablets: 325 mg aspirin tablets (USP)"
740910|NCT01646671|B3|Baseline|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740911|NCT01646671|B2|Baseline|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740912|NCT01646671|B1|Baseline|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740913|NCT01646671|P3|Participant Flow|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740914|NCT01646671|P2|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740915|NCT01646671|P1|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740916|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
740935|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740936|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
740917|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740918|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740919|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740920|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
740921|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740922|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740923|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740924|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
740925|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
754232|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
740926|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740927|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740928|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
740929|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740930|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740931|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740932|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
740933|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740934|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
746218|NCT01624350|O3|Outcome|Permacol Collagen Paste - 6 Month Post-op|
740937|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740938|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740939|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740940|NCT01646671|O4|Outcome|Total Participants|All participants who were treated
740941|NCT01646671|O3|Outcome|LCZ696 400 mg Plus Other Hypertension (HTN) Medications|All participants were started on LCZ696 200 mg once daily on day 1. For participants who received LCZ696 400 mg and did not achieve msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and had no signs of safety concerns, another class of antihypertensive drugs (other than Angiotensin II receptor blockers or Angiotensin Converting Enzyme Inhibitor (ACEi) could be added, or the dose of concomitant antihypertensive drugs could be increased as per the package insert. Participants who received LCZ696 400 mg once daily did not change their dose for the remainder of the study.
740942|NCT01646671|O2|Outcome|LCZ696 400 mg|All participants were started on LCZ696 200 mg once daily on day 1. For participants who did not achieve mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4, and did not have any signs of safety concerns, the LCZ696 dose was increased to 400 mg once daily.
740943|NCT01646671|O1|Outcome|LCZ696 200 mg|All participants were started on LCZ696 200 mg once daily on day 1. Participants who achieved mean sitting diastolic blood pressure (msDBP) of < 100 mmHg and mean sitting systolic blood pressure (msSBP) of < 160 mmHg at week 2 or a msDBP < 90 mmHg and msSBP < 140 mmHg at or after week 4 and for the duration of the study continued at 200 mg LCZ696 once daily.
740944|NCT01646671|E4|Reported Event|Total Participants|All participants who were treated
740945|NCT01646671|E3|Reported Event|LCZ 400 mg + Other HTN Medications|LCZ 400 mg + other HTN medications
740946|NCT01646671|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
740947|NCT01646671|E1|Reported Event|LCZ 200 mg|LCZ 200 mg
740948|NCT01646398|B3|Baseline|Total|Total of all reporting groups
740949|NCT01646398|B2|Baseline|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
743092|NCT01641653|O1|Outcome|Placebo|Normal saline: Normal saline 2cc. IV one dose prior to OR
740950|NCT01646398|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740951|NCT01646398|P2|Participant Flow|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
740952|NCT01646398|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740953|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
740954|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740955|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
740956|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740957|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
740958|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740959|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
740960|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740961|NCT01646398|O2|Outcome|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
740962|NCT01646398|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740963|NCT01646398|E2|Reported Event|23vPS|23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly on Day 1.
740964|NCT01646398|E1|Reported Event|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
740965|NCT01646385|B3|Baseline|Total|Total of all reporting groups
740966|NCT01646385|B2|Baseline|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740967|NCT01646385|B1|Baseline|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
743552|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
740968|NCT01646385|P2|Participant Flow|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740969|NCT01646385|P1|Participant Flow|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740970|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740971|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740972|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740973|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740974|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740975|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740976|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740977|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740978|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740979|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740980|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740981|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
741025|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
741155|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
740982|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740983|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740984|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740985|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740986|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740987|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
741007|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741008|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
740988|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740989|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740990|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740991|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740992|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740993|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740994|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740995|NCT01646385|O2|Outcome|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
741055|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
743553|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
740996|NCT01646385|O1|Outcome|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740997|NCT01646385|E2|Reported Event|nbDMARDs|Biological naive participants with active RA who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC were observed using the data in BSRBR for a maximum of 8.75 years. Doses of nbDMARDs and any concomitant medication could be adjusted according to medical and therapeutic necessity.
740998|NCT01646385|E1|Reported Event|Etanercept|Participants with active rheumatoid arthritis (RA) who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC) were observed using the data in British Society for Rheumatology Biologics Register (BSRBR) for a maximum of 10 years. Doses of ETN and any concomitant medication could be adjusted according to medical and therapeutic necessity. Participants were eligible to receive any other therapy instead of ETN, as per investigator’s discretion and the doses of these were not controlled in the follow-up.
740999|NCT01646320|B3|Baseline|Total|Total of all reporting groups
741000|NCT01646320|B2|Baseline|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741001|NCT01646320|B1|Baseline|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741002|NCT01646320|P2|Participant Flow|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741003|NCT01646320|P1|Participant Flow|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741004|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741005|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741006|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741435|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741009|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741010|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741011|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741012|NCT01646320|O2|Outcome|Pla+Saxa+Met|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741013|NCT01646320|O1|Outcome|Dapa+Saxa+Met|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741014|NCT01646320|E2|Reported Event|PLA + SAXA + MET|Participants received dapagliflozin matching placebo and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741015|NCT01646320|E1|Reported Event|DAPA + SAXA + MET|Participants received dapagliflozin, 10 mg, and open-label saxagliptin 5 mg and metformin ≥1500 mg per day for up to 52 weeks
741016|NCT01646268|B3|Baseline|Total|Total of all reporting groups
741017|NCT01646268|B2|Baseline|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
741018|NCT01646268|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
741019|NCT01646268|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
741020|NCT01646268|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
741021|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
741022|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
741023|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
741024|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
741026|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
741027|NCT01646268|O2|Outcome|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
741028|NCT01646268|O1|Outcome|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
741029|NCT01646268|E2|Reported Event|Placebo|"Placebo, daily doses, placebo group~Placebo Patch: Transdermal Patch~Size:~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2~Subjects randomized to placebo will receive matching placebo patches."
741030|NCT01646268|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment group~Rotigotine: Transdermal Patch~Content:~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period."
741031|NCT01646255|B3|Baseline|Total Title|
741032|NCT01646255|B2|Baseline|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
741033|NCT01646255|B1|Baseline|Placebo|Subjects randomized to placebo received matching placebo patches.
741034|NCT01646255|P2|Participant Flow|Rotigotine|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
741035|NCT01646255|P1|Participant Flow|Placebo|Subjects randomized to placebo received matching placebo patches.
741036|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741037|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741172|NCT01646138|O4|Outcome|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
741436|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741038|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741039|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741040|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741041|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741042|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741043|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741044|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741045|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741046|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741047|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741048|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741049|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741050|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741051|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741052|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741053|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741054|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741056|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741057|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741058|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo was achieved. Each dose level was maintained for 1 week.
741059|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741060|NCT01646255|O2|Outcome|Full Analysis Set (Rotigotine Treated Subjects)|Subjects received rotigotine in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h was achieved. Each dose level was maintained for 1 week.
741061|NCT01646255|O1|Outcome|Full Analysis Set (Placebo Treated Subjects)|Subjects randomized to placebo received matching placebo patches.
741062|NCT01646255|E2|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group~Subjects will receive rotigotine or placebo patches in escalating weekly doses (starting with daily doses of rotigotine 4 mg/ 24 h or matching placebo) until an optimal dose or maximal dose of rotigotine 16 mg/ 24 h or matching placebo is achieved. A combination of patches (rotigotine or matching placebo) will be applied for subjects who require a dose > 8 mg/ 24 h. Each dose level is maintained for 1 week."
741063|NCT01646255|E1|Reported Event|Placebo|"Placebo, daily doses, placebo Group~Subjects randomized to placebo will receive matching placebo patches."
741064|NCT01646177|B5|Baseline|Total|Total of all reporting groups
741065|NCT01646177|B4|Baseline|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741066|NCT01646177|B3|Baseline|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8).~Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741173|NCT01646138|O3|Outcome|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
754233|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
741067|NCT01646177|B2|Baseline|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741068|NCT01646177|B1|Baseline|Placebo|Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12.
741069|NCT01646177|P4|Participant Flow|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10). Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741070|NCT01646177|P3|Participant Flow|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10.~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741071|NCT01646177|P2|Participant Flow|50 mg Etanercept|Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12. Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10).
741072|NCT01646177|P1|Participant Flow|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741073|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741074|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741075|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741076|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741077|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741078|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741079|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741080|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741195|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741081|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741082|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741083|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741084|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741085|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741086|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741087|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741088|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741089|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741397|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
741090|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741091|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741092|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741093|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741094|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741095|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741096|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741097|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741098|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741099|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741100|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741101|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741102|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741103|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741104|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741105|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741106|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741107|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741108|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741109|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741110|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741111|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741112|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741113|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741114|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741115|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741116|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741117|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741118|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741119|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741120|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741121|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741122|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741123|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741124|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741125|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741126|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741127|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741128|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741129|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741130|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741131|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741132|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741133|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741134|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741135|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741136|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741137|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741138|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741139|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741140|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741141|NCT01646177|O4|Outcome|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12."
741142|NCT01646177|O3|Outcome|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|A starting dose of 160 mg (Week 0) given as 2 SC injections followed by 80 mg given as 1 SC injection Q4W (Weeks 4 and 8). Placebo for ixekizumab given as 1 SC injection at Weeks 2, 6, and 10. Placebo for etanercept (1 SC injection) given twice weekly starting at Week 0 up to Week 12.
741143|NCT01646177|O2|Outcome|50 mg Etanercept|"Etanercept 50 mg (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 and up to Week 12.~Placebo for ixekizumab given as 2 SC injections (Week 0) followed by placebo for ixekizumab Q2W given as 1 SC injection (Weeks 2, 4, 6, 8, and 10)."
741144|NCT01646177|O1|Outcome|Placebo|"Placebo for ixekizumab (Week 0) given as 2 SC injections followed by placebo for ixekizumab Q2W (Weeks 2, 4, 6, 8, and 10).~Placebo for etanercept (1 SC injection) given twice weekly (every 3-4 days) starting at Week 0 up to Week 12."
741145|NCT01646177|E4|Reported Event|80 mg Ixekizumab Dosing Regimen 1 (Q2W)|"Administered by two 80 milligram (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection Q2W until Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).~80 mg ixekizumab: Administered SC"
741146|NCT01646177|E3|Reported Event|80 mg Ixekizumab Dosing Regimen 2 (Q4W)|"Administered by two 80 mg SC injections at Week 0, then one 80 mg SC injection Q4W until Week 264.~80 mg ixekizumab: Administered SC"
741147|NCT01646177|E2|Reported Event|50 mg Etanercept|"Administered by SC injections twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2.~50 mg etanercept: Administered SC"
741148|NCT01646177|E1|Reported Event|Placebo|"Placebo for ixekizumab administered by two SC injections at Week 0, then one SC injection per Dosing Regimen 1 (Q2W) until Week 12.~Placebo for etanercept administered by one SC injection twice weekly starting at Week 0 up to Week 12. At Week 12, arm is assigned to Dosing Regimen 2 (Q4W).~Placebo: Administered SC"
741149|NCT01646151|B1|Baseline|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741150|NCT01646151|P1|Participant Flow|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741151|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741152|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741153|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741154|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741156|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741157|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741158|NCT01646151|O1|Outcome|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741159|NCT01646151|E1|Reported Event|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
741160|NCT01646138|B6|Baseline|Total|Total of all reporting groups
741161|NCT01646138|B5|Baseline|10^7 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^7 TCID50 administered intranasally.
741162|NCT01646138|B4|Baseline|10^6 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^6 TCID50 administered intranasally.
741163|NCT01646138|B3|Baseline|10^5 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^5 TCID50 administered intranasally.
741164|NCT01646138|B2|Baseline|10^4 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^4 TCID50 administered intranasally.
741165|NCT01646138|B1|Baseline|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
741166|NCT01646138|P5|Participant Flow|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
741167|NCT01646138|P4|Participant Flow|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
741168|NCT01646138|P3|Participant Flow|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
741169|NCT01646138|P2|Participant Flow|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
741170|NCT01646138|P1|Participant Flow|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
741171|NCT01646138|O5|Outcome|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
741174|NCT01646138|O2|Outcome|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
741175|NCT01646138|O1|Outcome|10^3 TCID 50|Participants received influenza A(H1N1) pdm09 at a dose of 10^3 TCID 50 administered intranasally.
741176|NCT01646138|E5|Reported Event|10^7 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^7 TCID50 in 1ml given intranasally.
741177|NCT01646138|E4|Reported Event|10^6 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^6 TCID50 in 1ml given intranasally.
741178|NCT01646138|E3|Reported Event|10^5 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^5 TCID50 in 1ml given intranasally.
741179|NCT01646138|E2|Reported Event|10^4 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^4 TCID50 in 1ml given intranasally.
741180|NCT01646138|E1|Reported Event|10^3 TCID 50|Participants received Ca/04/2009/H1N1 Vero Grown Challenge Virus at a dose of 10^3 TCID50 in 1ml given intranasally.
741181|NCT01646125|B3|Baseline|Total|Total of all reporting groups
741182|NCT01646125|B2|Baseline|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741183|NCT01646125|B1|Baseline|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741184|NCT01646125|P2|Participant Flow|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741185|NCT01646125|P1|Participant Flow|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741186|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741187|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741188|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741189|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741190|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741191|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741192|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741193|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741194|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741196|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741197|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741198|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741199|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741200|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741201|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741202|NCT01646125|O2|Outcome|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741203|NCT01646125|O1|Outcome|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741204|NCT01646125|E3|Reported Event|Total|Total
741205|NCT01646125|E2|Reported Event|Chemotherapy Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the control arm drug arm.~Pemetrexed or docetaxel was to be was to be given once every three weeks."
741206|NCT01646125|E1|Reported Event|AUY922 Arm|"Participants were assigned to one of two treatment arms in a ratio of 1:1. This was the investigational drug arm.~AUY922 was to be administered weekly."
741207|NCT01646073|B3|Baseline|Total|Total of all reporting groups
741208|NCT01646073|B2|Baseline|Adalimumab Eow|Participants were started on adalimumab 40 mg every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
741209|NCT01646073|B1|Baseline|Placebo|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B
741210|NCT01646073|P2|Participant Flow|Adalimumab Eow|Participants were started on 40 mg adalimumab every other week (eow) in Period A and continued adalimumab 40 mg eow into Period B
741211|NCT01646073|P1|Participant Flow|Placebo|Participants were started on placebo in Period A and then switched to adalimumab 40 mg eow in Period B
741398|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
741212|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741213|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741214|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741215|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741216|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741217|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741218|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741219|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741220|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741221|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741222|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741223|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741224|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741225|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741226|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741227|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741228|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741229|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741230|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741231|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741232|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741233|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741234|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741235|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741236|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741466|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741237|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741238|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741239|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741240|NCT01646073|O2|Outcome|Adalimumab Eow/Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A and continued 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741241|NCT01646073|O1|Outcome|Placebo/Adalimumab Eow|Participants were started on placebo in Period A and then switched to 40 mg adalimumab eow in Period B (Week 12 to Week 24).
741242|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741243|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741244|NCT01646073|O2|Outcome|Adalimumab Eow|Participants were started on 40 mg adalimumab eow in Period A (Week 0 to Week 12).
741245|NCT01646073|O1|Outcome|Placebo|Participants were started on placebo in Period A (Week 0 to Week 12).
741246|NCT01646073|E3|Reported Event|Any Adalimumab|Participants that received at least one dose of adalimumab during Period A or Period B
741247|NCT01646073|E2|Reported Event|Double-blind Adalimumab Eow|Participants were started on adalimumab eow in Period A (Week 0 to Week 12)
741248|NCT01646073|E1|Reported Event|Double-blind Placebo|Participants were started on placebo in Period A (Week 0 to Week 12)
741249|NCT01646021|B3|Baseline|Total|Total of all reporting groups
741250|NCT01646021|B2|Baseline|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741251|NCT01646021|B1|Baseline|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741252|NCT01646021|P2|Participant Flow|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741253|NCT01646021|P1|Participant Flow|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741399|NCT01645059|O1|Outcome|Disseminated HER 2 + Breast Cancer|
741254|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741255|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741256|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741257|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741258|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741259|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741260|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741261|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741262|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741263|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741264|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741265|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741266|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741267|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741268|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741269|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741270|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741271|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741272|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741273|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741274|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741275|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741276|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741277|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741278|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741279|NCT01646021|O2|Outcome|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741280|NCT01646021|O1|Outcome|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741281|NCT01646021|E2|Reported Event|Temsirolimus|Participants receive Temsirolimus intravenous (IV) infusion 175 mg on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each subsequent 21 day cycle. Each temsirolimus dose is infused over a 30 to 60 minute period.
741400|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
741401|NCT01645059|O1|Outcome|Disseminated Her 2+ Breast Cancer|
741282|NCT01646021|E1|Reported Event|Ibrutinib|Participants received 560 milligram (mg) ibrutinib (4 x 140 mg capsules) by mouth once daily continuous (without interruption) self-administered home treatment during the 21 day cycle.
741283|NCT01645735|B3|Baseline|Total|Total of all reporting groups
741284|NCT01645735|B2|Baseline|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
741285|NCT01645735|B1|Baseline|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
741286|NCT01645735|P2|Participant Flow|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
741287|NCT01645735|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
741288|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
741289|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
741290|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
741291|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
741292|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2g IV q24 plus vancomycin 15mg/kg IV q12h initially and then dose adjusted based on trough concentrations
741293|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
741294|NCT01645735|O2|Outcome|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV q24 plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
741295|NCT01645735|O1|Outcome|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
741296|NCT01645735|E2|Reported Event|Ceftriaxone Plus Vancomycin|Ceftriaxone 2 g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations
741297|NCT01645735|E1|Reported Event|Ceftaroline|Ceftaroline fosamil 600 mg IV over 60 minutes q8h
741298|NCT01645709|B3|Baseline|Total|Total of all reporting groups
741299|NCT01645709|B2|Baseline|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741300|NCT01645709|B1|Baseline|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741301|NCT01645709|P2|Participant Flow|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741302|NCT01645709|P1|Participant Flow|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741303|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741304|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741305|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741306|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741307|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741308|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741309|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741310|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741311|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741312|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741313|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741314|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741315|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741316|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741317|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741318|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741319|NCT01645709|O2|Outcome|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741320|NCT01645709|O1|Outcome|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741321|NCT01645709|E2|Reported Event|Placebo|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Placebo"
741322|NCT01645709|E1|Reported Event|Verapamil|"Subjects will be randomized to receive a single injection of IA Verapamil or IA Placebo at a ratio of 1:1.~Verapamil"
741323|NCT01645280|B6|Baseline|Total|Total of all reporting groups
741324|NCT01645280|B5|Baseline|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741325|NCT01645280|B4|Baseline|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741402|NCT01645059|E1|Reported Event|Disseminated Her 2+ Breast Cancer|
741498|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741326|NCT01645280|B3|Baseline|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
741327|NCT01645280|B2|Baseline|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741328|NCT01645280|B1|Baseline|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
741329|NCT01645280|P5|Participant Flow|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741330|NCT01645280|P4|Participant Flow|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741331|NCT01645280|P3|Participant Flow|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
741332|NCT01645280|P2|Participant Flow|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741333|NCT01645280|P1|Participant Flow|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
741334|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741335|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741336|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
741337|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741338|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
741339|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741340|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741341|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
741342|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741343|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
741344|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
743761|NCT01637935|B1|Baseline|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
741345|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741346|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
741347|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741348|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
741349|NCT01645280|O5|Outcome|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741350|NCT01645280|O4|Outcome|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741351|NCT01645280|O3|Outcome|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
741352|NCT01645280|O2|Outcome|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741353|NCT01645280|O1|Outcome|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
741354|NCT01645280|E6|Reported Event|CNTO1959 50 mg Every 8 Weeks|Participants randomized to receive CNTO1959 50 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741355|NCT01645280|E5|Reported Event|CNTO1959 200 mg Every 8 Weeks|Participants randomized to receive CNTO1959 200 mg subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741403|NCT01644734|B1|Baseline|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
741356|NCT01645280|E4|Reported Event|Ustekinumab 90 mg Every 12 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 12 weeks (Week 16 and 28) along with methotrexate.
741357|NCT01645280|E3|Reported Event|Ustekinumab 90 mg Every 8 Weeks|Participants randomized to receive ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate.
741358|NCT01645280|E2|Reported Event|Placebo (Early Escape)|Participants who early escaped at Week 16 and received ustekinumab 90 milligram (mg) subcutaneously at Week 16, 20 and 28 along with methotrexate.
741359|NCT01645280|E1|Reported Event|Placebo|Participants randomized to receive matching placebo subcutaneously at Week 0, 4 and then every 8 weeks (Week 12, 20 and 28) along with methotrexate. 16 participants in placebo group early escaped to receive the study drug Ustekinmab.
741360|NCT01645176|B1|Baseline|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
741361|NCT01645176|P1|Participant Flow|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
741362|NCT01645176|O1|Outcome|Osteoarthritis of Knee|Change in MRI synovitis
741363|NCT01645176|E1|Reported Event|Hydroxychloroquine/Atorvastatin Open Label|Hydroxychloroquine/Atorvastatin: Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
741364|NCT01645111|B1|Baseline|Clevidipine|Clevidipine
741365|NCT01645111|P1|Participant Flow|Clevidipine|Clevidipine
741366|NCT01645111|O1|Outcome|Clevidipine|Clevidipine
741367|NCT01645111|E1|Reported Event|Clevidipine|Clevidipine
741368|NCT01645098|B3|Baseline|Total|Total of all reporting groups
741369|NCT01645098|B2|Baseline|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741370|NCT01645098|B1|Baseline|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741371|NCT01645098|P2|Participant Flow|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741372|NCT01645098|P1|Participant Flow|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741373|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741374|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741375|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741376|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741377|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741378|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741379|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741380|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741381|NCT01645098|O2|Outcome|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741382|NCT01645098|O1|Outcome|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741383|NCT01645098|E2|Reported Event|Dexmedetomidine 0.5 mcg/kg|"Patients receive a loading dose of dexmedetomidine 0.5 mcg/kg followed by a continuous infusion of 0.5 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741384|NCT01645098|E1|Reported Event|Dexmedetomidine 1 mcg/kg|"Patients receive a loading dose of dexmedetomidine 1 mcg/kg followed by a continuous infusion of 1 mcg/kg/hr.~Ketamine: 1 mg/kg IV, additional doses of 0.5 mg/kg as needed~Dexmedetomidine: 0.5 mcg/kg/hr IV"
741385|NCT01645059|B1|Baseline|Disseminated Her 2+ Breast Cancer|
741386|NCT01645059|P1|Participant Flow|Disseminated Her 2+ Breast Cancer|
741387|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
741388|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
741389|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
741390|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
741391|NCT01645059|O2|Outcome|No Taxanes First Line Treatment|
741392|NCT01645059|O1|Outcome|Taxanes First Line Treatment|
741393|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
741394|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
741395|NCT01645059|O2|Outcome|No Trastuzumab Adjuvant Treatment|
741396|NCT01645059|O1|Outcome|Trastuzumab Adjuvant Treatment|
741404|NCT01644734|P1|Participant Flow|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
741405|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
741406|NCT01644734|O1|Outcome|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
741407|NCT01644734|E1|Reported Event|Patients Treated With Spiriva HandiHaler|Inhalator is administered once daily in the dosage of 18µg.
741408|NCT01644695|B1|Baseline|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
741409|NCT01644695|P1|Participant Flow|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
741410|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
741467|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741468|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741469|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741470|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741411|NCT01644695|O1|Outcome|Candidate for BARS Procedure.|"The subjects selected for this trial were over 18 years of age with an appropriate complex, incisional hernia. These patients were consented and treated with the BARS(bony anchoring reinforcement system)procedure.~Bony Anchoring Reinforcement System : Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to"
741412|NCT01644695|E1|Reported Event|All Participants|No participant was excempt from this measure.
741413|NCT01644643|B5|Baseline|Total|Total of all reporting groups
741414|NCT01644643|B4|Baseline|cUTI:CAZ-AVI|cUTI: CAZ-AVI
741415|NCT01644643|B3|Baseline|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741416|NCT01644643|B2|Baseline|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741417|NCT01644643|B1|Baseline|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741418|NCT01644643|P4|Participant Flow|cUTI:CAZ-AVI|cUTI: CAZ-AVI
741419|NCT01644643|P3|Participant Flow|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741420|NCT01644643|P2|Participant Flow|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741421|NCT01644643|P1|Participant Flow|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741422|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
741423|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
741424|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
741425|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
741426|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
741427|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
741428|NCT01644643|O6|Outcome|AVI (3)|300-360 mins after dose
741429|NCT01644643|O5|Outcome|CAZ (3)|300-360 mins after dose
741430|NCT01644643|O4|Outcome|AVI (2)|30-90 mins after dose
741431|NCT01644643|O3|Outcome|CAZ (2)|30-90 mins after dose
741432|NCT01644643|O2|Outcome|AVI (1)|15 mins before/after dose
741433|NCT01644643|O1|Outcome|CAZ (1)|15 mins before/after dose
741437|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741438|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741439|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741440|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741441|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741442|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741443|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741444|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741445|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741446|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741447|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741448|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741449|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741450|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741451|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741452|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741453|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741454|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741455|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741456|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741457|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741458|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741459|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741460|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741461|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741462|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741463|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741464|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741465|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741471|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741472|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741473|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741474|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741475|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741476|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741477|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741478|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741479|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741480|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741481|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741482|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741483|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741484|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741485|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741486|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741487|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741488|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741489|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741490|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741491|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741492|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741493|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741494|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741495|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741496|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741497|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741499|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741500|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741501|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741502|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741503|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741504|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741505|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741506|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741507|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741508|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741509|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741510|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741511|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741512|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741513|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741514|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741515|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741516|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741517|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741518|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741519|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741520|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741521|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741522|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741523|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741524|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741525|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741526|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
746219|NCT01624350|O2|Outcome|Permacol Collagen Paste - 3 Month Post-op|
741527|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741528|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741529|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741530|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741531|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741532|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741533|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741534|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741535|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741536|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741537|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741538|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741539|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741540|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741541|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741542|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741543|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741544|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741545|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741546|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741547|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741548|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741549|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741550|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741551|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741552|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741553|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741554|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741555|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741556|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741557|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741558|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741559|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741560|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741561|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741562|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741563|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741564|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741565|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741566|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741567|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741568|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741569|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741570|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741571|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741572|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741573|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741574|NCT01644643|O4|Outcome|cUTI:CAZ-AVI|cUTI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam)
741575|NCT01644643|O3|Outcome|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741576|NCT01644643|O2|Outcome|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741577|NCT01644643|O1|Outcome|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741578|NCT01644643|E4|Reported Event|cUTI:CAZ-AVI|cUTI: CAZ-AVI
741579|NCT01644643|E3|Reported Event|cUTI:Best Available Therapy|cUTI:Best Available Therapy Determinated by Investigator
741580|NCT01644643|E2|Reported Event|cIAI:CAZ-AVI + Metronidazole|cIAI:CAZ-AVI (2000 mg ceftazidime/500 mg avibactam) plus metronidazole (500 mg)
741581|NCT01644643|E1|Reported Event|cIAI:Best Available Therapy|cIAI: Best Available Therapy Determinated by Investigator
741582|NCT01644617|B4|Baseline|Total|Total of all reporting groups
744090|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
741583|NCT01644617|B3|Baseline|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741584|NCT01644617|B2|Baseline|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741585|NCT01644617|B1|Baseline|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741586|NCT01644617|P3|Participant Flow|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741587|NCT01644617|P2|Participant Flow|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741588|NCT01644617|P1|Participant Flow|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741589|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741590|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741591|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741592|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741593|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741594|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741595|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741596|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741597|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741598|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741599|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
743093|NCT01641653|E2|Reported Event|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
741600|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741601|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741602|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741603|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741604|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741605|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741606|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741607|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741608|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741609|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741610|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741611|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741612|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741613|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741614|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741615|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741616|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741617|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741720|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741618|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741619|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741620|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741621|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741622|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741623|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741624|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741625|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741626|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741627|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741628|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741629|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741630|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741631|NCT01644617|O3|Outcome|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741632|NCT01644617|O2|Outcome|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741633|NCT01644617|O1|Outcome|MK-8237 12 DU|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741634|NCT01644617|E3|Reported Event|Placebo|Participants received placebo rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
754234|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
741635|NCT01644617|E2|Reported Event|MK-8237 6 DU|Participants received MK-8237 6 DU rapidly dissolving tablet administered sublingually q.d., at approximately the same time each day, for 24 weeks.
741636|NCT01644617|E1|Reported Event|MK-8237 12 Development Units (DU)|Participants received MK-8237 12 DU rapidly dissolving tablet administered sublingually once daily (q.d.), at approximately the same time each day, for 24 weeks.
741637|NCT01643525|B1|Baseline|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
741638|NCT01643525|P1|Participant Flow|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
741639|NCT01643525|O1|Outcome|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
741640|NCT01643525|E1|Reported Event|Nautilus NeuroWave Recording Arm|"Nautilus NeuroWaveTM System~Nautilus NeuroWaveTM System: Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke."
741641|NCT01644500|B4|Baseline|Total|Total of all reporting groups
741642|NCT01644500|B3|Baseline|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741643|NCT01644500|B2|Baseline|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741644|NCT01644500|B1|Baseline|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741645|NCT01644500|P3|Participant Flow|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741646|NCT01644500|P2|Participant Flow|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741647|NCT01644500|P1|Participant Flow|1.5 mg Dulaglutide|1.5 milligrams (mg) dulaglutide administered as one subcutaneous (SC) injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741648|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741649|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741650|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741651|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741756|NCT01644474|E1|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg (mean exposure of 22 weeks).
741652|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741653|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741654|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741655|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741656|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741657|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741658|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741659|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741660|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741661|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741662|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741663|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741664|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741665|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741666|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741667|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741668|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741669|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741670|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741671|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741672|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741673|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741674|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741675|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741676|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741677|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741678|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741679|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741680|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741681|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741682|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741683|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741684|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741685|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741686|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741687|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741688|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741689|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741690|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741691|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741692|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741693|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741694|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741695|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741696|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741697|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741698|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741699|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741700|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741701|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741702|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741703|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741704|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741705|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741706|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741707|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741708|NCT01644500|O3|Outcome|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741709|NCT01644500|O2|Outcome|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741710|NCT01644500|O1|Outcome|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741711|NCT01644500|E3|Reported Event|Glimepiride|1 to 3 mg/day glimepiride administered orally as one to three capsules per day plus one SC injection of placebo once-weekly for blinding purposes for up to 26 weeks.
741712|NCT01644500|E2|Reported Event|0.75 mg Dulaglutide|0.75 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741713|NCT01644500|E1|Reported Event|1.5 mg Dulaglutide|1.5 mg dulaglutide administered as one SC injection once-weekly plus one to three capsules of placebo each day for blinding purposes for up to 26 weeks.
741714|NCT01644474|B3|Baseline|Total|Total of all reporting groups
741715|NCT01644474|B2|Baseline|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741716|NCT01644474|B1|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741717|NCT01644474|P2|Participant Flow|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741718|NCT01644474|P1|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous (SC) placebo injection for alirocumab every 2 weeks (Q2W) for 24 weeks.
741719|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741721|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741722|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741723|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741724|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741725|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741726|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741727|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741728|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741729|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741730|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741731|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741732|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741733|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741734|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741735|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741736|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
743357|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
741737|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741738|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741739|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741740|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741741|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741742|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741743|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741744|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741745|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741746|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741747|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741748|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741749|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741750|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741751|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741752|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741753|NCT01644474|O2|Outcome|Alirocumab 75/Up to 150 mg Q2W|SC injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily for 24 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741754|NCT01644474|O1|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and SC placebo injection for alirocumab Q2W for 24 weeks.
741755|NCT01644474|E2|Reported Event|Alirocumab 75/Up150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W (mean exposure of 22 weeks).
746220|NCT01624350|O1|Outcome|Baseline - Pre-operatively|
741757|NCT01644396|B1|Baseline|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741758|NCT01644396|P1|Participant Flow|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741759|NCT01644396|O1|Outcome|Adalimumab|Number of participants with adverse events
741760|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741761|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741762|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741763|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741764|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741765|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741766|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741767|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741768|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741769|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741770|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741853|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741771|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741772|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741773|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741774|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741775|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741776|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741777|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741778|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741779|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741780|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741781|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741782|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741783|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741784|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741785|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741786|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741787|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741948|NCT01644175|E2|Reported Event|Alirocumab 75 /up to 150 mg Q2W|Participants exposed to alirocumab 75 mg /up to 150 mg SC injection Q2W added to stable LMT (mean exposition of 46 weeks).
741788|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741789|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741790|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741791|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741792|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741793|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741794|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741795|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741796|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741797|NCT01644396|O1|Outcome|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741798|NCT01644396|E1|Reported Event|Adalimumab|Participants received an initial adalimumab 80 mg subcutaneous dose, followed by adalimumab 40 mg subcutaneous every other week starting one week after the initial dose for up to 24 weeks.
741799|NCT01644331|B3|Baseline|Total|Total of all reporting groups
741800|NCT01644331|B2|Baseline|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741923|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741801|NCT01644331|B1|Baseline|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741802|NCT01644331|P2|Participant Flow|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741803|NCT01644331|P1|Participant Flow|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741804|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741805|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741806|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741807|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741808|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741809|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741810|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741811|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741812|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741813|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741814|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741815|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
744903|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
741816|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741817|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741818|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741819|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741820|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741821|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741822|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741823|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741824|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741825|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
743419|NCT01640054|P1|Participant Flow|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
741826|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741827|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741828|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741829|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741830|NCT01644331|O2|Outcome|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741831|NCT01644331|O1|Outcome|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741832|NCT01644331|E2|Reported Event|Placebo|"IV furosemide (1 x oral dose given IV Q12 divided doses or 40mg IV Q12 hours, whichever is greater) plus oral placebo (given at O, 24, 48 hours)~Placebo: IV furosemide (1 x oral dose given IV in Q12 hours divided doses) plus oral placebo (given at 0, 12, 24 and 48 hours)"
741833|NCT01644331|E1|Reported Event|Tolvaptan|"IV furosemide (1 x oral dose given IV in Q12 hours divided doses or 40 mg IV Q12 hours, whichever is greater) plus oral Tolvaptan (given at 0, 12, 24 and 48 hours)~Tolvaptan: Tolvaptan (given at 0, 12, 24 and 48 hours)"
741834|NCT01644292|B1|Baseline|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
741835|NCT01644292|P1|Participant Flow|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
741836|NCT01644292|O1|Outcome|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
741837|NCT01644292|E1|Reported Event|Training Intervention|EPIC WheelS : EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
741838|NCT01644188|B3|Baseline|Total|Total of all reporting groups
741839|NCT01644188|B2|Baseline|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741840|NCT01644188|B1|Baseline|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741841|NCT01644188|P2|Participant Flow|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741872|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741842|NCT01644188|P1|Participant Flow|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg every 2 weeks (Q2W) and oral placebo capsule for ezetimibe daily added to stable Lipid­ Modifying Therapy (LMT) for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low density lipoprotein cholesterol (LDL-C) level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741843|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741844|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741845|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741846|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741847|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741848|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741849|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741850|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741851|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741852|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
743420|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
741854|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741855|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741856|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741857|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741858|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741859|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741860|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741861|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741862|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741863|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741864|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741865|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741866|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741867|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741868|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741869|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741870|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741871|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741873|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741874|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741875|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741876|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741877|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741878|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741879|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741880|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741881|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741882|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741883|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741884|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741885|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
743358|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
741886|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741887|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741888|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741889|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741890|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741891|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741892|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741893|NCT01644188|O2|Outcome|Ezetimibe 10 mg|Oral ezetimibe 10 mg capsule daily and subcutaneous placebo injection for alirocumab Q2W added to stable LMT for 104 weeks.
741894|NCT01644188|O1|Outcome|Alirocumab 75 /up to 150 mg Q2W|Subcutaneous injection of alirocumab 75 mg Q2W and oral placebo capsule for ezetimibe daily added to stable LMT for 104 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C level ≥70 mg/dL (1.81 mmol/L) at Week 8.
741895|NCT01644188|E2|Reported Event|Ezetimibe 10 mg|Participants exposed to Ezetimibe 10 mg added to stable LMT (mean exposition of 90 weeks).
741896|NCT01644188|E1|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 /up to 150 mg Q2W added to stable LMT (mean exposition of 90 weeks).
741897|NCT01644175|B3|Baseline|Total|Total of all reporting groups
741898|NCT01644175|B2|Baseline|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741899|NCT01644175|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741900|NCT01644175|P2|Participant Flow|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741901|NCT01644175|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable Lipid-Modifying Therapy (LMT) for 52 weeks.
741902|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741903|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741904|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741905|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741906|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741907|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741908|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741909|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741910|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741911|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741912|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741913|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741914|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741915|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741916|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741917|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741918|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741919|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741920|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741921|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741922|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741924|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741925|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741926|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741927|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741928|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741929|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741930|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741931|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741932|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741933|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741934|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741935|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741936|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741937|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741938|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741939|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741940|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741941|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741942|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741943|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741944|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741945|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741946|NCT01644175|O2|Outcome|Alirocumab 75/150 mg Q2W|Alirocumab 75 mg SC injection Q2W added to stable LMT for 52 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥70 mg/dL (1.81 mmol/L) at Week 8.
741947|NCT01644175|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 52 weeks.
741949|NCT01644175|E1|Reported Event|Placebo Q2W|Participants exposed to placebo (for alirocumab) SC injection Q2W added to stable LMT (mean exposition of 45 weeks).
741950|NCT01644058|B1|Baseline|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
741951|NCT01644058|P1|Participant Flow|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
741952|NCT01644058|O1|Outcome|Immediate Loading|"Immediate loading of 2 endo-osseous mandibular implants~Immediate loading"
741953|NCT01644058|O1|Outcome|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
741954|NCT01644058|E1|Reported Event|Immediate Loading|Immediate loading of 2 endo-osseous mandibular implants
741955|NCT01643928|B6|Baseline|Total|Total of all reporting groups
741956|NCT01643928|B5|Baseline|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
741957|NCT01643928|B4|Baseline|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
741958|NCT01643928|B3|Baseline|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
743359|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
741959|NCT01643928|B2|Baseline|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
741960|NCT01643928|B1|Baseline|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
741961|NCT01643928|P5|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
741962|NCT01643928|P4|Participant Flow|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
741963|NCT01643928|P3|Participant Flow|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
741964|NCT01643928|P2|Participant Flow|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742298|NCT01643044|O2|Outcome|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
741965|NCT01643928|P1|Participant Flow|PF-05280586/PF-05280586/PF-05280586|This group received intravenous (IV) rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
741966|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741967|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
741968|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742366|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
743421|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
741969|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741970|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741971|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741972|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
741973|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741974|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741975|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741976|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741977|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
741978|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741979|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742367|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
743422|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
741980|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741981|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741982|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
741983|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741984|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741985|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741986|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742332|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742333|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
741987|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
741988|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741989|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742368|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
741990|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741991|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741992|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
741993|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741994|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741995|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741996|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741997|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742334|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
744904|NCT01631825|E1|Reported Event|SPM 962|SPM 962 transdermal patch
741998|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
741999|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742000|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742369|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742001|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742002|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742003|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742004|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742005|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742006|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742007|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742008|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742335|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742009|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742010|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742011|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742370|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
743360|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
742012|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742013|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742014|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742015|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742016|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742017|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742018|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742019|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742020|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742021|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742022|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742023|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742024|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742025|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742026|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742027|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742028|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742029|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742030|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742336|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742337|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
744905|NCT01631812|B1|Baseline|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
742031|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742032|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742371|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
743361|NCT01640314|E2|Reported Event|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
742033|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742034|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742035|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742036|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742037|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742038|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742039|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742040|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742041|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742338|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742339|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
745442|NCT01628913|B2|Baseline|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
742042|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742372|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742373|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742806|NCT01641926|P2|Participant Flow|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742043|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742044|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742045|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742046|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742047|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742048|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742049|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742050|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742051|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742052|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742053|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742374|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742054|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742055|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742056|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742057|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742058|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742059|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742060|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742061|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742062|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742063|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742340|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
747913|NCT01614249|B3|Baseline|Total|Total of all reporting groups
742075|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742064|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742065|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742066|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742067|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742068|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742069|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742070|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742071|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742072|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742073|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742074|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742341|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742076|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742077|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742078|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742079|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742080|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742081|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742082|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742083|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742084|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742085|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742342|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742343|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
743339|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
742086|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742087|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742088|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742089|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742090|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742091|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742092|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742093|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742094|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742095|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742096|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742097|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742098|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742099|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742100|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742101|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742102|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742103|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742104|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742105|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742106|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742107|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742344|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742108|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742109|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742110|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742111|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742112|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742113|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742114|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742115|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742116|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742117|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742118|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742345|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742346|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
743340|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
742130|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742119|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742120|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742121|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742122|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742123|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742124|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742125|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742126|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742127|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742128|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742129|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742347|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
748665|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
742131|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742132|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742133|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742134|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742135|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742136|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742137|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742138|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742139|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742140|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742141|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742142|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742143|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742144|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742145|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742146|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742147|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742148|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742149|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742150|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742151|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742348|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742349|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
745443|NCT01628913|B1|Baseline|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
742163|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742152|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742153|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742154|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742155|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742156|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742157|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742158|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742159|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742160|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742161|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742162|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742350|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742164|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742165|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742166|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742167|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742168|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742169|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742170|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742171|NCT01643928|O5|Outcome|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742172|NCT01643928|O4|Outcome|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742173|NCT01643928|O3|Outcome|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742351|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742174|NCT01643928|O2|Outcome|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
743423|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
742175|NCT01643928|O1|Outcome|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742176|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742177|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742178|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742179|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742180|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742181|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742182|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742183|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742184|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742352|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
746221|NCT01624350|O2|Outcome|Permacol Collagen Paste - 12 Month Follow up|
742185|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742186|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742187|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742188|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742189|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742190|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742191|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742192|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742193|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742194|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742195|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742353|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
746222|NCT01624350|O1|Outcome|Permacol Collagen Paste - 3 Month Follow up|
742196|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742197|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742198|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742199|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742200|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742201|NCT01643928|O5|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742202|NCT01643928|O4|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742203|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742204|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742205|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742206|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
742207|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742221|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742208|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742209|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
742210|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742211|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742212|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742213|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
742214|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742215|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742216|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
742217|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742218|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742219|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742220|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
742354|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742355|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742222|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742223|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
742224|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742225|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742226|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742227|NCT01643928|O7|Outcome|Rituximab-US Total|Participants who received Rituximab-US in the B3281001 study were either assigned Rituximab-US in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-US participants.
742228|NCT01643928|O6|Outcome|PF-05280586/PF-05280586/PF-05280586 (US)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742229|NCT01643928|O5|Outcome|Rituximab-US/PF-05280586/PF-05280586|This group received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24­-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24­week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-US in the B3281001 study.
742230|NCT01643928|O4|Outcome|Rituximab-EU Total|Participants who received Rituximab-EU in the B3281001 study were either assigned Rituximab-EU in the first course of B3281004, or PF-05280586. This measures the total percentage of B3281001 Rituximab-EU participants.
742231|NCT01643928|O3|Outcome|PF-05280586/PF-05280586/PF-05280586 (EU)|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24­-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742232|NCT01643928|O2|Outcome|Rituximab-EU/PF-05280586/PF-05280586|This group received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of a 24-week (±8 week) course followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 2 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received Rituximab-EU in the B3281001 study.
742233|NCT01643928|O1|Outcome|PF-05280586/PF-05280586/PF-05280586|This group received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of up to 3 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care. Participants in this treatment arm received PF-05280586 in the B3281001 study.
742234|NCT01643928|E15|Reported Event|PF-05280586 (US): by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742235|NCT01643928|E14|Reported Event|Rituximab-US/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742236|NCT01643928|E13|Reported Event|PF-05280586 (EU): by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742237|NCT01643928|E12|Reported Event|Rituximab-EU/PF-05280586/PF-05280586: by the End of Course 3|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second and third 24-week (±8 week) courses. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742238|NCT01643928|E11|Reported Event|PF-05280586: by the End of Course 3|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of all three 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742239|NCT01643928|E10|Reported Event|PF-05280586 (US): by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742240|NCT01643928|E9|Reported Event|Rituximab-US/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742241|NCT01643928|E8|Reported Event|PF-05280586 (EU): by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742242|NCT01643928|E7|Reported Event|Rituximab-EU/PF-05280586: by the End of Course 2|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study, followed by IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the second 24-week (±8 week) course. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742243|NCT01643928|E6|Reported Event|PF-05280586: by the End of Course 2|This treatment group, which received PF-05280586 in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first two 24-week (±8 week) courses in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742356|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742357|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
743341|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
742244|NCT01643928|E5|Reported Event|PF-05280586 (US): by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742245|NCT01643928|E4|Reported Event|Rituximab-US: by the End of Course 1|This treatment group, which received Rituximab-US in the B3281001 study, received IV rituximab (Rituxan) infusion 1000 mg/500 mL (preceded by 100 mg methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance) for up to 25 weeks. Folate supplementation was encouraged according to local standard of care.
742246|NCT01643928|E3|Reported Event|PF-05280586 (EU): by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742247|NCT01643928|E2|Reported Event|Rituximab-EU: by the End of Course 1|This treatment group, which received Rituximab-EU in the B3281001 study, received IV rituximab (MabThera) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742248|NCT01643928|E1|Reported Event|PF-05280586: by the End of Course 1|This treatment group, which received PF-05280586 during the B3281001 study, received IV rituximab (PF-05280586) infusion 1000 mg/500 mL (preceded by 100 mg IV methylprednisolone or its equivalent, an antipyretic, and an antihistamine) on Study Days 1 and 15 of the first 24-week (±8 week) course in this three course study. Participants continued to receive a stable background regimen of methotrexate 10 to 25 mg/week (7.5 mg/week in the event of prior poor tolerance). Folate supplementation was encouraged according to local standard of care.
742249|NCT01643902|B1|Baseline|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
742250|NCT01643902|P1|Participant Flow|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~rt-PA: IV rt-PA 0.9 mg/kg minimum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target foor to needle time of 60 minutes or less from ED arrival."
742251|NCT01643902|O1|Outcome|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
742252|NCT01643902|O1|Outcome|IV Rt-PA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from Emergency department (ED) arrival."
742253|NCT01643902|E1|Reported Event|IV tPA|"Treatment will be initiated within 4.5 hours of awakening, for patients who meet inclusion criteria~IV tPA: IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival."
742254|NCT01643876|B1|Baseline|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
742255|NCT01643876|P1|Participant Flow|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
742256|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
742257|NCT01643876|O1|Outcome|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
742258|NCT01643876|E1|Reported Event|Palatal Brushing|"Palatal brushing after each meal for 3 months.~Palatal brushing : Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing."
742358|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742363|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742364|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742365|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742259|NCT01643798|B1|Baseline|Pretreatment & Stimulation|Outside of the 3T magnetic resonance imaging (MRI) scanner, participants underwent resting motor threshold assessment, left dorsolateral prefrontal cortex localization and preliminary pain testing. Next, participants were placed in the scanner for baseline pain testing. After baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive approximately 10 ml intravenous naloxone (0.1mg/kg) or saline immediately prior to 20 minutes of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20 minutes of real left DLPFC rTMS. Participants then returned to the scanner for the final block test.
742260|NCT01643798|P2|Participant Flow|Naloxone and Stimulation, Then Saline and Stimulation|Participants received an intravenous infusion of 0.1mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
742261|NCT01643798|P1|Participant Flow|Saline and Stimulation, Then Naloxone and Stimulation|Participants received an intravenous infusion of 10ml sterile saline immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex. One week later, participants received an intravenous infusion of 0.1 mg/kg Naloxone immediately prior to sham and real rTMS of the left dorsolateral prefrontal cortex
742262|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
742263|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
742264|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
742265|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit. Whole-brain and anatomical region of interest analysis were performed. The numbers below represent midbrain percent signal change.
742266|NCT01643798|O4|Outcome|Real rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
742267|NCT01643798|O3|Outcome|Sham rTMS With Naloxone|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
742359|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742360|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742361|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742268|NCT01643798|O2|Outcome|Real rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
742269|NCT01643798|O1|Outcome|Sham rTMS With Saline|Participants first underwent baseline pain testing in the scanner. At the conclusion of baseline testing, participants were asked to rate the pain that they had experienced. Participants were subsequently removed from the scanner and randomized to receive 10 ml intravenous (I.V.) naloxone (0.1 mg/kg) or saline immediately before 20 min of sham left DLFPC rTMS. Following sham rTMS, participants returned to the scanner for the same block testing performed at baseline. After rating their pain, participants were removed from the scanner for 20min of real left DLPFC rTMS. Participants then returned to the scanner for the final block test. The I.V. pretreatment was randomized such that participants received saline on one visit and naloxone on the other visit.
742270|NCT01643798|E1|Reported Event|Pretreatment & Stimulation|
742271|NCT01643616|B3|Baseline|Total|Total of all reporting groups
742272|NCT01643616|B2|Baseline|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742273|NCT01643616|B1|Baseline|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742274|NCT01643616|P2|Participant Flow|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742275|NCT01643616|P1|Participant Flow|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742276|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742277|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742278|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742279|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742280|NCT01643616|O2|Outcome|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742281|NCT01643616|O1|Outcome|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742282|NCT01643616|E2|Reported Event|Group NS|"Nerve stimulation technique:~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742283|NCT01643616|E1|Reported Event|Group US|"Ultrasound guided block :~20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)"
742284|NCT01643213|B3|Baseline|Total|Total of all reporting groups
742285|NCT01643213|B2|Baseline|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
742286|NCT01643213|B1|Baseline|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
742287|NCT01643213|P2|Participant Flow|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
742288|NCT01643213|P1|Participant Flow|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
742289|NCT01643213|O2|Outcome|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
742290|NCT01643213|O1|Outcome|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
742291|NCT01643213|E2|Reported Event|Control to Treatment|Control (non-BSC SCS Therapy) followed by Treatment (BSC SCS Therapy)
742292|NCT01643213|E1|Reported Event|Treatment to Control|Treatment (BSC SCS Therapy) followed by Control (non-BSC SCS Therapy)
742293|NCT01643044|B3|Baseline|Total|Total of all reporting groups
742294|NCT01643044|B2|Baseline|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
742295|NCT01643044|B1|Baseline|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
742296|NCT01643044|P2|Participant Flow|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
742297|NCT01643044|P1|Participant Flow|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
742362|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
746223|NCT01624350|O1|Outcome|Permacol Collagen Paste|
742299|NCT01643044|O1|Outcome|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
742300|NCT01643044|E2|Reported Event|Control|"Participants randomized into the control condition complete assessment and a time-matched interactive session on infant nutrition.~Nutrition time control/placebo intervention: This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos."
742301|NCT01643044|E1|Reported Event|Alcohol Intervention|"Participants in this condition review tailored videos and normed feedback regarding their alcohol use and possible consequences of drinking. Next participants view a goal setting section describing possible ways to quit drinking alcohol and the participant is able to indicate a change goal (if any) and is helped through a specific change plan, should they set a change goal.~Computer-delivered, brief intervention on alcohol use: A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant."
742302|NCT01642914|B4|Baseline|Total|Total of all reporting groups
742303|NCT01642914|B3|Baseline|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742304|NCT01642914|B2|Baseline|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742305|NCT01642914|B1|Baseline|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742306|NCT01642914|P3|Participant Flow|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742307|NCT01642914|P2|Participant Flow|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742308|NCT01642914|P1|Participant Flow|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742309|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742310|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742311|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast
742312|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742313|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742314|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742315|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742316|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742317|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742318|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742319|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742320|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742321|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742322|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742323|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742324|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742325|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742326|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742327|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742328|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742329|NCT01642914|O3|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742330|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742331|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742375|NCT01642914|O2|Outcome|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742376|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742377|NCT01642914|O2|Outcome|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742378|NCT01642914|O1|Outcome|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742379|NCT01642914|E3|Reported Event|Linaclotide 290 Micrograms|"Linaclotide 290 micrograms~Linaclotide 290 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742380|NCT01642914|E2|Reported Event|Linaclotide 145 Micrograms|"Linaclotide 145 micrograms~Linaclotide 145 micrograms: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742381|NCT01642914|E1|Reported Event|Placebo|"Matching placebo~Matching placebo: oral capsule, taken once daily each morning at least 30 minutes before breakfast"
742382|NCT01642732|B1|Baseline|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
742383|NCT01642732|P1|Participant Flow|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
742384|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
742415|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742416|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742417|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742418|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742385|NCT01642732|O1|Outcome|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
742386|NCT01642732|E1|Reported Event|Everolimus With Combined Hormonal and Radiation Therapy|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.~Lupron injections will begin on study day 10 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
742387|NCT01642615|B1|Baseline|All Participants|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks in the Open Label Healing Phase. Participants with healing of EE were eligible to participate in the Maintenance Phase.
743424|NCT01640054|O1|Outcome|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
742388|NCT01642615|P3|Participant Flow|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
742389|NCT01642615|P2|Participant Flow|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
742390|NCT01642615|P1|Participant Flow|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
742391|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
742392|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
742393|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
742394|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
742395|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
742396|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
742397|NCT01642615|O2|Outcome|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
742398|NCT01642615|O1|Outcome|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
742399|NCT01642615|O1|Outcome|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
742400|NCT01642615|E3|Reported Event|Maintenance Phase: Placebo|Participants who are healed at Week 8 will be randomized to receive dexlansoprazole placebo-matching capsules, orally, once daily for up to 16 weeks.
742401|NCT01642615|E2|Reported Event|Maintenance Phase: Dexlansoprazole 30 mg|Participants who are healed at Week 8 will be randomized to receive 30 mg dexlansoprazole delayed-release capsules, orally, once daily for up to 16 weeks.
742402|NCT01642615|E1|Reported Event|Healing Phase: Dexlansoprazole 60 mg|Dexlansoprazole 60 mg delayed-release capsules, orally, once daily for up to 8 weeks.
742403|NCT01642602|B1|Baseline|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
742404|NCT01642602|P1|Participant Flow|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
742405|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
742406|NCT01642602|O1|Outcome|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
742407|NCT01642602|E1|Reported Event|Dexlansoprazole 30 mg|Dexlansoprazole 30 mg delayed-release capsules orally once daily for up to 4 weeks.
742408|NCT01642589|B3|Baseline|Total|Total of all reporting groups
742409|NCT01642589|B2|Baseline|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742410|NCT01642589|B1|Baseline|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742411|NCT01642589|P2|Participant Flow|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742412|NCT01642589|P1|Participant Flow|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742413|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742414|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742419|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742420|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742421|NCT01642589|O2|Outcome|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742422|NCT01642589|O1|Outcome|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742423|NCT01642589|E2|Reported Event|Tdap - Adacel® Group|Participants received Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap - Adacel®)
742424|NCT01642589|E1|Reported Event|Menactra® Group|Participants received Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)
742425|NCT01642485|B1|Baseline|All Study Participants|Subjects participating in the study attended for screening, two treatment periods (periods 1 and 2) of 4 assessment days each and a follow-up visit. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in fasted condition or with Continental breakfast, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. No wash-out was required between the other treatments investigated. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
742686|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742426|NCT01642485|P8|Participant Flow|Sequence 8|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fasted"
742427|NCT01642485|P7|Participant Flow|Sequence 7|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fasted"
742428|NCT01642485|P6|Participant Flow|Sequence 6|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fasted"
742429|NCT01642485|P5|Participant Flow|Sequence 5|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fed (with continental breakfast) Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fasted"
742430|NCT01642485|P4|Participant Flow|Sequence 4|"Period1:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
742431|NCT01642485|P3|Participant Flow|Sequence 3|"Period1:~Day 1: Continental breakfast Day 2: FDA breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
742432|NCT01642485|P2|Participant Flow|Sequence 2|"Period1:~Day 1: Insulin Clamp Day 2: Continental breakfast Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: FDA breakfast Day 2: Placebo Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
742433|NCT01642485|P1|Participant Flow|Sequence 1|"Period1:~Day 1: Placebo Day 2: Insulin Clamp Day 3: Moxiloxacin 400 mg fasted Washout period: 3 days~Period 2:~Day 1: Continental breakfast Day 2:FDA breakfast Day 3: Moxifloxacin 400 mg fed (with continental breakfast)"
742434|NCT01642485|O4|Outcome|Japanese Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
742435|NCT01642485|O3|Outcome|Japanese Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
742436|NCT01642485|O2|Outcome|Caucasian Fed Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (4h)
742437|NCT01642485|O1|Outcome|Caucasian Fasted Group|The results of concentration-effect analysis: the effect of moxifloxacin on QTcF (double difference of QTcF) at the time point of maximum mean concentrationof moxifloxacin (1h)
742438|NCT01642485|O3|Outcome|C-peptide|A euglycaemic/hyperinsulinaemic clamp involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous glucose and insulin production, and as a result reducing the release of C-peptides. This technique will firstly test whether hyperinsulinaemia has an effect on QT interval, and secondly whether C-peptide levels play any role in the proposed effect on the QT interval.
742439|NCT01642485|O2|Outcome|Glucose|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
742440|NCT01642485|O1|Outcome|Insulin Clamp|A euglycaemic/hyperinsulinaemic clamp was used to stop any endogenous C-peptide and insulin production. The clamp acutely raised the plasma insulin concentrations to a steady-state and maintained glucose concentrations at/or slightly lower than the individual subjects baseline reading. For each subject two 18G cannulas were inserted, one in the antecubital fossa for insulin and glucose infusions, and one for pharmacokinetic (PK) and blood glucose sampling.
742441|NCT01642485|O2|Outcome|Placebo|Time matched absolute value for QTcF for placebo treatment.
742442|NCT01642485|O1|Outcome|Moxifloxacin 400 mg Fasted|The highest change was at 2.5h time point, which is presented here.
742443|NCT01642485|O3|Outcome|Placebo at Baseline|a baseline QTcF measured on Day -1 of each period
742503|NCT01642277|E1|Reported Event|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
742904|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742444|NCT01642485|O2|Outcome|Continental Breakfast|"Continental breakfast: High carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.~QTcF change from a baseline presented."
742445|NCT01642485|O1|Outcome|FDA Breakfast|FDA breakfast: Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
742446|NCT01642485|O2|Outcome|Fed Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fed conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
742464|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
754235|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
742447|NCT01642485|O1|Outcome|Fasted Group|This study was designed as an open-label, randomized, placebo-controlled, crossover trial that evaluated the effect of a 400 mg oral dose of moxifloxacin in fasted conditions to a baseline and a placebo treatment. Data obtained on study days 1 and 2 compared the ECG effects of different types of food and placebo. Each period consisted of a baseline ECG day (day –1) and treatment days (days 1–3). Moxifloxacin was given in either the fed or fasted condition, on day 3 of each study period. The two periods were separated by at least 3 days to allow for the effects of moxifloxacin to wash-out. The ECG and samples for PK and PD analysis on the treatment days were taken at the corresponding clock time points as on the baseline days. Each subject received all treatments and all the comparisons between treatment effects were made intra-individually reducing the anticipated variability and thereby reducing the sample size.
742448|NCT01642485|E2|Reported Event|Moxifloxacin 400 mg Fed|"Moxifloxacin with food: Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.~No significant other Adverse Events have been reported."
742449|NCT01642485|E1|Reported Event|Moxifloxacin 400 mg Fasted|"Moxifloxacin fasted: One single dose of 400mg moxifloxacin after fasting - This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.~No significant other Adverse Events have been reported."
742450|NCT01642407|B1|Baseline|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742451|NCT01642407|P1|Participant Flow|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742452|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742453|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742454|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742455|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742456|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742457|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742458|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742459|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742504|NCT01642238|B1|Baseline|Antithrombotic Effects|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) using a randomized, two-treatment, two-period, cross-over design in healthy volunteers.
742460|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742461|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742462|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742463|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
754236|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
742465|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742466|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742467|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742468|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742469|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742470|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742471|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742472|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742473|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742474|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742475|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742476|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742477|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742478|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742479|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742480|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742481|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742482|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742804|NCT01641926|P4|Participant Flow|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742483|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742484|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742485|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742486|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742487|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742488|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742489|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742490|NCT01642407|O1|Outcome|Sildenafil|Participants received 10 mg or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with <=20 kg of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with >20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742491|NCT01642407|E1|Reported Event|Sildenafil|Participants received 10 milligram (mg) or 20 mg of Sildenafil (based on their body weight) orally, thrice daily on Day 1 (Baseline), Week 4, 8 and 16. Participants with less than or equal to (<=) 20 kilogram (kg) of body weight received 10 mg dose, thrice daily as powder for oral suspension and participants with greater than (>) 20 kg of body weight received 20 mg dose, thrice daily as film-coated tablets.
742492|NCT01642277|B3|Baseline|Total|Total of all reporting groups
742493|NCT01642277|B2|Baseline|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
742494|NCT01642277|B1|Baseline|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5mg daily solifenacin (with an option to increase to 10mg daily solifenacin at 4 weeks) for the treatment of urinary urge incontinence (UUI).
742495|NCT01642277|P2|Participant Flow|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
742496|NCT01642277|P1|Participant Flow|Urinary Urge Incontinence|Seventy-four (n = 74) women received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
742497|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
742498|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
742499|NCT01642277|O2|Outcome|Solifenacin Non-Responder|Individuals with urinary urge incontinence who did not respond to solifenacin at 12 weeks
742500|NCT01642277|O1|Outcome|Solifenacin Responder|Individuals with urinary urge incontinence who responded to solifenacin at 12 weeks
742501|NCT01642277|O1|Outcome|Urinary Urge Incontinence|Women who received 5-10mg daily solifenacin for the treatment of urinary urge incontinence (UUI).
742502|NCT01642277|E2|Reported Event|Non-Urinary Urge Incontinence|Sixty (n = 60) women without UUI were evaluated at baseline only (week 0) in order to serve as a control cohort. These women never received study therapy (i.e., 5-10mg daily solifenacin).
742505|NCT01642238|P2|Participant Flow|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
742506|NCT01642238|P1|Participant Flow|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week washout period in between.
742507|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742508|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
743362|NCT01640314|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
742509|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742510|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742511|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742512|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742513|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742514|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742515|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742516|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742517|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742518|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742519|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742541|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
743342|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
742520|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742521|NCT01642238|O2|Outcome|Clopidogrel + ASA + Bivalirudin|"Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Clopidogrel + ASA + Bivalirudin: Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
742522|NCT01642238|O1|Outcome|Ticagrelor + ASA + Bivalirudin|"Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.~Ticagrelor + ASA + Bivalirudin: Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour."
743363|NCT01640197|B3|Baseline|Total|Total of all reporting groups
742523|NCT01642238|E2|Reported Event|Clopidogrel, Then Ticagrelor|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
742524|NCT01642238|E1|Reported Event|Ticagrelor, Then Clopidogrel|Acute antithrombotic effects of ticagrelor (180 mg + 90 mg) versus clopidogrel (600mg), when coadministered with aspirin (81mg) and bivalirudin (weight-adjusted clinical dose, given as bolus plus 1-hour infusion) with a 1-2 week wash out period in between.
742525|NCT01642212|B3|Baseline|Total|Total of all reporting groups
742526|NCT01642212|B2|Baseline|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742527|NCT01642212|B1|Baseline|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742528|NCT01642212|P5|Participant Flow|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
742529|NCT01642212|P4|Participant Flow|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
742530|NCT01642212|P3|Participant Flow|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742531|NCT01642212|P2|Participant Flow|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742532|NCT01642212|P1|Participant Flow|Single-blind Placebo|Eligible participants entered a 4-week, single-blind, placebo baseline period. Participants ingested the first dose of placebo in the clinic in the presence of study center personnel, and the remaining doses were ingested at home. Participants took placebo twice daily (bid); once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742533|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742534|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742535|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742536|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742537|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742538|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742539|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742540|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742755|NCT01641939|B4|Baseline|Total|Total of all reporting groups
742542|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742543|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742544|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742545|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742546|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742547|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742548|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742549|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742550|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742551|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742552|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742553|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742554|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742555|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742556|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742557|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742558|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742559|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742560|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742561|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742562|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742563|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742564|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742565|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742566|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742905|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742567|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742568|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742569|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742570|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742646|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742571|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742572|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742573|NCT01642212|O2|Outcome|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2 mg OBS (formulation MB-9) twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742574|NCT01642212|O1|Outcome|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742575|NCT01642212|E4|Reported Event|Oral Budesonide Suspension (OBS) 2 mg to Open-label OBS 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
742576|NCT01642212|E3|Reported Event|Placebo to Open-label Oral Budesonide Suspension (OBS) 2 mg|During the first 12 weeks of open-label extension treatment, participants took 2 mg OBS (formulation MB-9) once daily (qd) at bedtime. The volume per dose was 10 mL of oral liquid (10 mL qd; 0.2 mg/mL). Thereafter, an optional dose increase to 1.5 mg twice daily (bid) (7.5 mL bid; 0.2 mg/mL) and then to 2 mg bid (10 mL bid; 0.2 mg/mL) was allowed for subjects whose response to the 2 mg once daily dose was inadequate, as determined by the Investigator; a dose decrease to 2 mg once daily was allowed at any time.
742577|NCT01642212|E2|Reported Event|Double-blind Oral Budesonide Suspension (OBS) 2 mg|Participants took 2mg OBS (formulation MB-9) 2 mg twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742578|NCT01642212|E1|Reported Event|Double-blind Placebo|Participants took placebo twice daily (bid) at home for 12 weeks. Study drug was administered once in the morning after breakfast and once in the evening at bedtime; the volume per dose was 10 mL of oral liquid.
742579|NCT01642147|B3|Baseline|Total|Total of all reporting groups
742580|NCT01642147|B2|Baseline|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742581|NCT01642147|B1|Baseline|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742582|NCT01642147|P2|Participant Flow|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742583|NCT01642147|P1|Participant Flow|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742584|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742585|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742586|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742587|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742588|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742589|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742590|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742591|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742592|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742593|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742594|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742595|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742596|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742597|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742598|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742599|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742600|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742601|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742602|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742603|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742604|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742605|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742606|NCT01642147|O2|Outcome|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742607|NCT01642147|O1|Outcome|Craniotomy Group|"Patients who are scheduled for selective supratentorial tumor removal surgery will be randomly chosen and recruited.~Transcranial Doppler (TCD) measures,jugular venous bulb catheterization, radial artery catheterization, and tumor removal surgery under general anesthesia will be performed."
742608|NCT01642147|E2|Reported Event|Craniotomy Group|Randomly chosen patients undergoing selective craniotomy surgery. Transcranial Doppler measures,jugular venous bulb catheterization, radial artery catheterization, and craniotomy under general anesthesia will be performed.
742609|NCT01642147|E1|Reported Event|Abdominal Surgery Group|Randomly chosen patients undergoing selective abdominal surgery. Transcranial Doppler measures,radial artery catheterization, and abdominal surgery under general anesthesia will be performed.
742610|NCT01642082|B1|Baseline|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
742611|NCT01642082|P1|Participant Flow|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
742612|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
742613|NCT01642082|O1|Outcome|Treatment (Dalantercept)|"Patients receive dalantercept SC on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Dalantercept: Given SC~Laboratory Biomarker Analysis: Correlative studies"
746224|NCT01624350|E1|Reported Event|Permacol Collagen Paste|
742614|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
742615|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
742616|NCT01642082|O1|Outcome|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
742617|NCT01642082|E1|Reported Event|Dalantercept|"Dalantercept 1.2 mg/kg (maximum starting dose of 120 mg) subcutaneously once every three weeks. One cycle is defined as three weeks.~Patients weighing more than 100 kg start treatment at 120 mg, and if dalantercept is tolerated for 2 cycles (i.e. toxicities are tolerable, less than grade 2 and resolved), the patient can be dose escalated to dosing based on actual body weight.~A CT of the chest, abdomen and pelvis to assess response by RECIST 1.1 is required every two cycles. Treatment was to continue until disease progression or adverse effects prohibit further therapy."
742618|NCT01642004|B3|Baseline|Total|Total of all reporting groups
742619|NCT01642004|B2|Baseline|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742620|NCT01642004|B1|Baseline|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742621|NCT01642004|P2|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742622|NCT01642004|P1|Participant Flow|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742623|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742624|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742625|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742626|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742627|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742628|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742629|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742630|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742631|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742632|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742633|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742634|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742635|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742636|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742637|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742638|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742639|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742640|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742641|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742642|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742643|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742644|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742645|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
743425|NCT01640054|E1|Reported Event|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
742647|NCT01642004|O2|Outcome|Docetaxel|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742648|NCT01642004|O1|Outcome|Nivolumab|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742649|NCT01642004|E2|Reported Event|DOCETAXEL|Docetaxel 75 mg/m^2 solution intravenously every 3 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742650|NCT01642004|E1|Reported Event|NIVOLUMAB|Nivolumab 3 mg/kg solution intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
742651|NCT01641991|B5|Baseline|Total|Total of all reporting groups
742652|NCT01641991|B4|Baseline|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742653|NCT01641991|B3|Baseline|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742654|NCT01641991|B2|Baseline|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742655|NCT01641991|B1|Baseline|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742656|NCT01641991|P4|Participant Flow|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742657|NCT01641991|P3|Participant Flow|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742658|NCT01641991|P2|Participant Flow|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742659|NCT01641991|P1|Participant Flow|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742660|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742661|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742662|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742663|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742664|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742665|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742666|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742667|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742668|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742669|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742670|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742671|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742672|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742673|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742674|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742675|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742676|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742677|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742678|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
743343|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
742679|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742680|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742681|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742682|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742683|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742684|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742685|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
743426|NCT01639833|B3|Baseline|Total|Total of all reporting groups
742687|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742688|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742689|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742690|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742691|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742692|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742693|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742694|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742695|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742696|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742697|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742698|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742699|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742700|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742701|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742702|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742703|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742704|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742705|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742706|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742707|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742708|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742709|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742710|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742711|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742712|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742713|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742714|NCT01641991|O1|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742715|NCT01641991|O3|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742716|NCT01641991|O2|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742717|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742718|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
743344|NCT01640327|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
742719|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742720|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742721|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742722|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742723|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742724|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742725|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742726|NCT01641991|O4|Outcome|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742727|NCT01641991|O3|Outcome|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742728|NCT01641991|O2|Outcome|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742729|NCT01641991|O1|Outcome|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742730|NCT01641991|E4|Reported Event|Arm D: 0.25mL BioThrax, Days 0, 14, 28|BioThrax 0.25ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742731|NCT01641991|E3|Reported Event|Arm C: 0.50mL BioThrax, Days 0, 14, 28|BioThrax 0.50ml subcutaneously on Days 0, 14, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742732|NCT01641991|E2|Reported Event|Arm B: 0.50mL BioThrax, Days 0, 28|BioThrax 0.50ml subcutaneously on Days 0, 28, and 0.50mL BioThrax intramuscularly at 6 month boost
742733|NCT01641991|E1|Reported Event|Arm A: 0.50mL BioThrax, Days 0, 14|BioThrax 0.50ml subcutaneously on Days 0, 14, and 0.50mL BioThrax intramuscularly at 6 month boost
742734|NCT01641978|B1|Baseline|Neurologic Level|Neurologic patients
742735|NCT01641978|P1|Participant Flow|Neurologic Level|Neurologic patients
742736|NCT01641978|O1|Outcome|Critical Care Time Experience|Influence of work experience in the evaluation of neurological patients
742737|NCT01641978|O3|Outcome|Slight|patients with GCS > 12 points
742738|NCT01641978|O2|Outcome|Moderate|patients with GCS 9 - 12 points
742739|NCT01641978|O1|Outcome|Severe|patients with GCS < 9 points
742740|NCT01641978|O1|Outcome|Neurologic Level|Neurologic patients
742741|NCT01641978|E1|Reported Event|Neurologic Level|Neurologic patients
742742|NCT01641952|B1|Baseline|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742743|NCT01641952|P1|Participant Flow|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742744|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742745|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742746|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742747|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742748|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742749|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742750|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742751|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742752|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742753|NCT01641952|O1|Outcome|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742754|NCT01641952|E1|Reported Event|Rituximab|Participants who had an inadequate response or intolerance to one anti- tumor necrosis factor (anti-TNF) agent received rituximab (Mabthera) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
742756|NCT01641939|B3|Baseline|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742757|NCT01641939|B2|Baseline|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742758|NCT01641939|B1|Baseline|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742759|NCT01641939|P3|Participant Flow|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
754237|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
742760|NCT01641939|P2|Participant Flow|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742761|NCT01641939|P1|Participant Flow|Standard Taxane Therapy|Docetaxel was administered at 75 milligram per meter square (mg/m^2) intravenously (IV) on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742762|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742763|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742764|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742765|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742766|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742767|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742768|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742769|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742770|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742771|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742772|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742773|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742774|NCT01641939|O1|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742775|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742776|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742777|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742778|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742779|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742780|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742805|NCT01641926|P3|Participant Flow|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
754238|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
742781|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742782|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742783|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742784|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742785|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742786|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742787|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742788|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742789|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742790|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742791|NCT01641939|O3|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742792|NCT01641939|O2|Outcome|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742793|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742794|NCT01641939|O2|Outcome|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742795|NCT01641939|O1|Outcome|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742796|NCT01641939|E3|Reported Event|Trastuzumab Emtansine 3.6 mg|Trastuzumab emtansine was administered on Days 1 of a 21-day cycle at 3.6 mg/kg IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742797|NCT01641939|E2|Reported Event|Trastuzumab Emtansine 2.4 mg|Trastuzumab emtansine was administered on Days 1, 8, and 15 of a 21-day cycle at 2.4 milligram per kilogram (mg/kg) IV infusion until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742840|NCT01641900|O1|Outcome|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
742798|NCT01641939|E1|Reported Event|Standard Taxane Therapy|Docetaxel was administered at 75 mg/m^2 IV on Day 1 of a 21-day cycle, or paclitaxel was administered at 80 mg/m^2 IV weekly (Days 1, 8, and 15 of a 21 day cycle) as per investigator's choice, until progression of disease, intolerable toxicity, initiation of another anticancer therapy, or participants and/or physician decision to discontinue.
742799|NCT01641926|B5|Baseline|Total|Total of all reporting groups
742800|NCT01641926|B4|Baseline|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742801|NCT01641926|B3|Baseline|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
742802|NCT01641926|B2|Baseline|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742803|NCT01641926|B1|Baseline|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742807|NCT01641926|P1|Participant Flow|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742808|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742809|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
742810|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742811|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742812|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742813|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
742814|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742815|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742816|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742817|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
742818|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742819|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742820|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742821|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
742822|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742823|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742824|NCT01641926|O4|Outcome|HBeAg(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742825|NCT01641926|O3|Outcome|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
742826|NCT01641926|O2|Outcome|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742827|NCT01641926|O1|Outcome|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742828|NCT01641926|E4|Reported Event|HBeAG(-) PEGASYS|HBeAg-negative participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742829|NCT01641926|E3|Reported Event|HBeAg(-) PEG-Intron|HBeAg-negative participants receive 1.5 mcg/kg/wk PEG-Intron SC once weekly for 48 weeks.
742830|NCT01641926|E2|Reported Event|HBeAg(+) PEGASYS|HBeAg-positive participants receive 180 mcg/kg/wk PEGASYS SC once weekly for 48 weeks.
742831|NCT01641926|E1|Reported Event|HBeAg(+) PEG-Intron|HBeAg-positive participants receive 1.5 mcg/kg/wk PEG-Intron subcutaneously (SC) once weekly for 48 weeks.
742832|NCT01641900|B3|Baseline|Total|Total of all reporting groups
742833|NCT01641900|B2|Baseline|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
742834|NCT01641900|B1|Baseline|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
742835|NCT01641900|P2|Participant Flow|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
742836|NCT01641900|P1|Participant Flow|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
742837|NCT01641900|O2|Outcome|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
742838|NCT01641900|O1|Outcome|Group: Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants completed both the Drug and Placebo arms.
742839|NCT01641900|O2|Outcome|Group: Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use. Participants completed both the Drug and Placebo arms.
742841|NCT01641900|E4|Reported Event|3mg Eszopiclone Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Drug Intervention.
742842|NCT01641900|E3|Reported Event|3mg Eszopiclone With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Drug Intervention.
742843|NCT01641900|E2|Reported Event|Placebo Healthy Controls|Adult participants screened to exclude a personal history of mental illness, family history of schizophrenia spectrum disorder, and psychoactive medication use.Participants who completed Placebo Intervention.
742844|NCT01641900|E1|Reported Event|Placebo With Schizophrenia|Outpatients with a Structural Clinical Interview confirmed DSM-IV diagnosis of schizophrenia. Participants who completed Placebo Intervention.
742845|NCT01641861|B3|Baseline|Total|Total of all reporting groups
742846|NCT01641861|B2|Baseline|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742914|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742847|NCT01641861|B1|Baseline|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742848|NCT01641861|P2|Participant Flow|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742849|NCT01641861|P1|Participant Flow|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742850|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742851|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742852|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742853|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742854|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742855|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742856|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742857|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742858|NCT01641861|O2|Outcome|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742859|NCT01641861|O1|Outcome|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742860|NCT01641861|E2|Reported Event|Intervention Arm|"Intervention arm is dental caries removal using Papacarie®. The dentist will apply Papacarie® to dental cavity in order to soften the carious dentine. Dental caries will be removed using hand instrument.~Papacarie®: Papacarie® is chemo-mechanical method for caries removal"
742861|NCT01641861|E1|Reported Event|Control Arm|"control arm is dental caries removal using the conventional method. Dental caries will be removed using rotary instrument following the usual procedures employed by the dentist.~Conventional method: caries removal by using rotary instrument."
742862|NCT01641835|B1|Baseline|Normals|No eye disease.
742863|NCT01641835|P1|Participant Flow|Normals|No eye disease.
742864|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
742865|NCT01641835|O1|Outcome|Healthy Volunteers|Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
742866|NCT01641835|E1|Reported Event|Normals|No adverse events were reported.
742867|NCT01641822|B3|Baseline|Total|Total of all reporting groups
742868|NCT01641822|B2|Baseline|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742869|NCT01641822|B1|Baseline|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742870|NCT01641822|P3|Participant Flow|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742871|NCT01641822|P2|Participant Flow|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742872|NCT01641822|P1|Participant Flow|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
742873|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742874|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742875|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
754239|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
742876|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742877|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742878|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742879|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742880|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742881|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742882|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742883|NCT01641822|O2|Outcome|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742884|NCT01641822|O1|Outcome|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742885|NCT01641822|E3|Reported Event|Placebo|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: placebo to match AZLI for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742886|NCT01641822|E2|Reported Event|AZLI|Participants were randomized to receive 3 cycles of treatment, each cycle consisting alternating regimens: AZLI (75 mg 3 times daily) for 28 days followed by TIS (300 mg 2 times daily) for 28 days.
742887|NCT01641822|E1|Reported Event|TIS Run-In Treatment Group|Enrolled participants received 28 days of TIS (300 mg 2 times daily) during the run-in phase.
742888|NCT01641692|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments :~UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo."
742889|NCT01641692|P8|Participant Flow|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742890|NCT01641692|P7|Participant Flow|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742891|NCT01641692|P6|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742892|NCT01641692|P5|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742893|NCT01641692|P4|Participant Flow|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742894|NCT01641692|P3|Participant Flow|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742895|NCT01641692|P2|Participant Flow|UMEC 15.6 µg QD|Participants received umeclidinium bromide (UMEC) 15.6 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742896|NCT01641692|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
742897|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742898|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742899|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742900|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742901|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742902|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742903|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
746225|NCT01624259|B3|Baseline|Total|Total of all reporting groups
742906|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742907|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742908|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742909|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742910|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742911|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742912|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742913|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
754240|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
742915|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742916|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742917|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742918|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742919|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742920|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742921|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742922|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742923|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742924|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742925|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742926|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742927|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742928|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742929|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742930|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742931|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742932|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742933|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742934|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742935|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742936|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742937|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742938|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742939|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742940|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742941|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742942|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742943|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742944|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742945|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742946|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742947|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742948|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742949|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742950|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742951|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742952|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742953|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742954|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742955|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742956|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742957|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742958|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742959|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742960|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742961|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742962|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742963|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742964|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742965|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742966|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742967|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742968|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742969|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742970|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742971|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742972|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742973|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742974|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742975|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742976|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742977|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742978|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742979|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742980|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742981|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742982|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742983|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742984|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742985|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742986|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742987|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742988|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742989|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742990|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742991|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742992|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
742993|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742994|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
742995|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742996|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742997|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742998|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
742999|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743000|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743001|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743002|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743003|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743004|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743005|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743006|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743007|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743008|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743009|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743010|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743011|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743012|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743013|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743014|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743015|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743016|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743017|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743018|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743019|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743020|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743021|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743022|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743023|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743024|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743025|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743026|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743027|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743028|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743029|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743030|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743031|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743032|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743033|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743034|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743035|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743036|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743037|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743038|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743039|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743040|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743041|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743042|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743043|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743044|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743045|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743046|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743047|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743048|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743049|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743050|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743051|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743052|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743053|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743054|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743055|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743056|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743057|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743058|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743059|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743060|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743061|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743062|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743063|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743064|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743065|NCT01641692|O8|Outcome|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743066|NCT01641692|O7|Outcome|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743067|NCT01641692|O6|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743068|NCT01641692|O5|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743069|NCT01641692|O4|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743070|NCT01641692|O3|Outcome|UMEC 31.25 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743071|NCT01641692|O2|Outcome|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743072|NCT01641692|O1|Outcome|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743073|NCT01641692|O1|Outcome|All Study Treatments|The treatment phase was comprised of three 14-day treatment periods. Treatment Period 1 and 2 were followed by a 12-14 day washout period. Treatment Period 3 was followed by a 5 to 9 day washout period before the Follow-up visit. Participants were randomly assigned to receive a sequence of 3 of the 8 active treatments : UMEC 15.6, 31.25, 62.5, 125, 250 µg QD and UMEC 15.6, 31.25 µg BID, placebo.
743074|NCT01641692|E8|Reported Event|UMEC 31.25 µg BID|Participants received UMEC 31.25 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743075|NCT01641692|E7|Reported Event|UMEC 15.6 µg BID|Participants received UMEC 15.6 µg in the morning via DPI A and in the evening via DPI B for 14 days.
743076|NCT01641692|E6|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743077|NCT01641692|E5|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743078|NCT01641692|E4|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743079|NCT01641692|E3|Reported Event|UMEC 31.5 µg QD|Participants received UMEC 31.25 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
748666|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
743080|NCT01641692|E2|Reported Event|UMEC 15.6 µg QD|Participants received UMEC 15.6 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
743081|NCT01641692|E1|Reported Event|Placebo|Participants received matching placebo in the morning via DPI A and in the evening via DPI B for 14 days.
743082|NCT01641653|B3|Baseline|Total|Total of all reporting groups
743083|NCT01641653|B2|Baseline|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
743084|NCT01641653|B1|Baseline|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
743085|NCT01641653|P2|Participant Flow|Midazolam|"half of the patients will receive Midazolam prior to entering the OR~Midazolam: 1-2.5 mg"
743086|NCT01641653|P1|Participant Flow|Placebo|"half of the patients will receive placebo (normal saline 2mL) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
743087|NCT01641653|O2|Outcome|Midazolam|subjects will receive midazolam 1.5-2mg prior to entering the OR
743088|NCT01641653|O1|Outcome|Placebo|subjects will receive 2cc. Normal Saline prior to entering the OR
743089|NCT01641653|O2|Outcome|Midazolam|half of subjects will receive Midazolam: 1-2.5 mgIV prior to entering the OR
743094|NCT01641653|E1|Reported Event|Placebo|"half of the patients will receive placebo (normal saline) prior to entering the OR~Normal saline: Normal saline 2cc. one dose prior to OR"
743095|NCT01641640|B1|Baseline|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743096|NCT01641640|P1|Participant Flow|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+pegylated interferon alfa 2a (PEG)+ribavirin (RBV) for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743097|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743098|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743099|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743100|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743101|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743102|NCT01641640|O1|Outcome|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743103|NCT01641640|E1|Reported Event|Sofosbuvir+PEG+RBV|"Participants received Sofosbuvir+PEG+RBV for 12 weeks and were followed for 24 weeks following treatment.~Sofosbuvir (400 mg) was administered as an oral tablet, PEG (180 µg) as a subcutaneous injection, and RBV (1000-1200 mg) as 200 mg oral tablets."
743104|NCT01641471|B3|Baseline|Total|Total of all reporting groups
743105|NCT01641471|B2|Baseline|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
743106|NCT01641471|B1|Baseline|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
743117|NCT01641237|P1|Participant Flow|Sodium Fluoride (NaF) Dentifrice,1426 Parts Per Million(Ppm)F|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 grams (g) ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743107|NCT01641471|P2|Participant Flow|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
743108|NCT01641471|P1|Participant Flow|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
754241|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
743109|NCT01641471|O2|Outcome|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
743110|NCT01641471|O1|Outcome|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
743111|NCT01641471|E2|Reported Event|Placebo TENS|"Placebo TENS in combination with a femoral nerve catheter. Patients will begin using a sham TENS unit (appears identical to Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation) immediately following surgery and continuing throughout the 6 weeks postoperatively.~Placebo EMPI Select TENS: Sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation (even though screen shows 0-60 milliamps of output current). The 4 electrodes will be focused on the posterior aspect of the knee during immediate postoperative period and lasting through discharge from the hospital. Once patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes"
743112|NCT01641471|E1|Reported Event|Active TENS|"Active TENS in combination with a femoral nerve catheter. Patients will begin using the TENS unit immediately following surgery and continuing throughout the 6 weeks postoperatively.~EMPI Select TENS: The unit is capable of 0-60 milliamps of output current. The 4 electrodes will be focused on the posterior aspect of the knee during the immediate postoperative period and lasting through discharge from the hospital. Once the patient is discharged, he/she will be instructed to use the device as he/she would like, whether it is a continuation of the posterior placement of the electrodes, or a more traditional anterior criss-cross positioning. Patients will be instructed to use the device for 2 hours on, followed by 30 minutes off, as needed. Amount of TENS usage and average intensity used will be recorded. An assessment of blinding will be conducted at the conclusion of the study by asking patients what treatment arm they think that they received."
743113|NCT01641237|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments.
743114|NCT01641237|P4|Participant Flow|Placebo Dentifrice (0ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743115|NCT01641237|P3|Participant Flow|NaF Dentifrice (250ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743116|NCT01641237|P2|Participant Flow|NaF Dentifrice (1150ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743118|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743119|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743120|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743121|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743122|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743123|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
754242|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
743124|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743125|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743126|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743127|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743128|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743129|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743130|NCT01641237|O4|Outcome|Placebo Dentifrice (0 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743131|NCT01641237|O3|Outcome|NaF Dentifrice (250 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743132|NCT01641237|O2|Outcome|NaF Dentifrice (1150 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743133|NCT01641237|O1|Outcome|NaF Dentifrice (1426 ppmF)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated. The direct contact between palatal appliance and toothbrush was avoided.
743134|NCT01641237|E4|Reported Event|Placebo Dentifrice (0 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of placebo toothpaste (0 ppmF) and expectorated.
743135|NCT01641237|E3|Reported Event|NaF Dentifrice (250 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (250 ppmF) and expectorated.
743136|NCT01641237|E2|Reported Event|NaF Dentifrice (1150 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1150 ppmF) and expectorated.
743137|NCT01641237|E1|Reported Event|NaF Dentifrice (1426 ppmF)|Participants brushed their teeth for one timed minute with 1.5 g ± 0.1g of NaF toothpaste (1426 ppmF) and expectorated.
743138|NCT01641159|B3|Baseline|Total|Total of all reporting groups
743139|NCT01641159|B2|Baseline|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
743140|NCT01641159|B1|Baseline|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
743212|NCT01641081|P3|Participant Flow|Sequence 3|Formoterol 12 μg Pressair; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Placebo Pressair; 24 μg Foradil Aerolizer
743141|NCT01641159|P2|Participant Flow|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
743142|NCT01641159|P1|Participant Flow|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
743143|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
743144|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
743145|NCT01641159|O2|Outcome|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
743146|NCT01641159|O1|Outcome|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
743147|NCT01641159|E2|Reported Event|Placebo Plus TAU|"Placebo taken daily for the 15-week active study~Placebo: Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets."
743148|NCT01641159|E1|Reported Event|Buspirone Plus TAU|"Buspirone titrated to 60 mg/day for the 15-week active study~Buspirone: Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated."
743149|NCT01641133|B4|Baseline|Total|Total of all reporting groups
743150|NCT01641133|B3|Baseline|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743151|NCT01641133|B2|Baseline|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743152|NCT01641133|B1|Baseline|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743153|NCT01641133|P3|Participant Flow|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743154|NCT01641133|P2|Participant Flow|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743155|NCT01641133|P1|Participant Flow|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743156|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743157|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743158|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743159|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743160|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743345|NCT01640327|E1|Reported Event|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
743161|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743162|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743163|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743164|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743165|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
754243|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
743166|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743167|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743168|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743169|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743170|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743171|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743172|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743173|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743174|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743175|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743176|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743177|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743178|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743179|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743180|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743213|NCT01641081|P2|Participant Flow|Sequence 2|12 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Placebo Pressair
743181|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743182|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743183|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743184|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743185|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743186|NCT01641133|O3|Outcome|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743187|NCT01641133|O2|Outcome|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743188|NCT01641133|O1|Outcome|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743189|NCT01641133|E3|Reported Event|Prevnar 2 Group|Subjects who were primed with two doses of Prevnar 13™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743190|NCT01641133|E2|Reported Event|Prevnar 1 Group|Subjects who were primed with Prevnar 13™ and Synflorix™ vaccines, administered intramuscularly into the right or left thigh, at 2 and 4 months of age respectively, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left thigh or in the deltoid, at 12-15 months of age.
743191|NCT01641133|E1|Reported Event|Synflorix Group|Subjects who were primed with two doses of Synflorix™ vaccine, administered intramuscularly into the right or left thigh, at 2 and 4 months of age, received a booster dose of Synflorix™ vaccine, administered intramuscularly into the right or left anterolateral thigh or in the deltoid, at 12-15 months of age.
743192|NCT01641120|B1|Baseline|All Study Participants|Avonex: Intramuscular injection administered using 30 gauge or 25 gauge needle
743193|NCT01641120|P1|Participant Flow|25 Gauge or 30 Gauge Needle|Avonex: Intramuscular injection administered using 25 gauge needle weeks 1, 4, and 5 and 30 gauge needle on weeks 2 and 3.
743194|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
743195|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
743196|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
743197|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
743198|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
743199|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
743200|NCT01641120|O2|Outcome|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex for weeks 2 and 3 of the study.
743201|NCT01641120|O1|Outcome|25 Gauge|Subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
743202|NCT01641120|E2|Reported Event|30 Gauge|Subjects used a 30 gauge needle for intramuscular injection of Avonex on weeks 2 and 3 of the study.
743203|NCT01641120|E1|Reported Event|25 Gauge|The same subjects used a 25 gauge needle for intramuscular injection of Avonex on weeks 4 and 5 of the study.
743204|NCT01641081|B1|Baseline|Overall Study Population|All patients participating in the crossover study
743205|NCT01641081|P10|Participant Flow|Sequence 10|Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Placebo Pressair
743206|NCT01641081|P9|Participant Flow|Sequence 9|12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; Placebo Pressair; Formoterol 6 μg Pressair
743207|NCT01641081|P8|Participant Flow|Sequence 8|24 μg Foradil Aerolizer; Placebo Pressair; 12 μg Foradil Aerolizer; Formoterol 6 μg Pressair; Formoterol 12 μg Pressair
743208|NCT01641081|P7|Participant Flow|Sequence 7|Placebo Pressair; Formoterol 6 μg Pressair; 24 μg Foradil Aerolizer; Formoterol 12 μg Pressair; 12 μg Foradil Aerolizer
743209|NCT01641081|P6|Participant Flow|Sequence 6|Formoterol 6 μg Pressair; Formoterol 12 μg Pressair; Placebo Pressair; 12 μg Foradil Aerolizer; 24 μg Foradil Aerolizer
743210|NCT01641081|P5|Participant Flow|Sequence 5|Placebo Pressair; 24 μg Foradil Aerolizer; Formoterol 6 μg Pressair; 12 μg Foradil Aerolizer; Formoterol 12 μg Pressair
743211|NCT01641081|P4|Participant Flow|Sequence 4|Formoterol 6 μg Pressair; Placebo Pressair; Formoterol 12 μg Pressair; 24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer
743346|NCT01640314|B3|Baseline|Total|Total of all reporting groups
743214|NCT01641081|P1|Participant Flow|Sequence 1|24 μg Foradil Aerolizer; 12 μg Foradil Aerolizer; Placebo Pressair; Formoterol 12 μg Pressair; Formoterol 6 μg Pressair
743215|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
743216|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
743217|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
743218|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
743219|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
743220|NCT01641081|O5|Outcome|Placebo|Administered via Pressair
743221|NCT01641081|O4|Outcome|Formoterol 6 μg|Administered via Pressair
743222|NCT01641081|O3|Outcome|Formoterol 12 μg|Administered via Pressair
743223|NCT01641081|O2|Outcome|Foradil 12 μg|Administered via Aerolizer
743224|NCT01641081|O1|Outcome|Foradil 24 μg|Administered via Aerolizer
743225|NCT01641081|E5|Reported Event|Placebo|Administered via Pressair
743226|NCT01641081|E4|Reported Event|Formoterol 6 μg|Administered via Pressair
743227|NCT01641081|E3|Reported Event|Formoterol 12 μg|Administered via Pressair
743228|NCT01641081|E2|Reported Event|Foradil 12 μg|Administered via Aerolizer
743229|NCT01641081|E1|Reported Event|Foradil 24 μg|Administered via Aerolizer
743230|NCT01640964|B4|Baseline|Total|Total of all reporting groups
743427|NCT01639833|B2|Baseline|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
743231|NCT01640964|B3|Baseline|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
743232|NCT01640964|B2|Baseline|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743233|NCT01640964|B1|Baseline|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
743234|NCT01640964|P3|Participant Flow|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
743235|NCT01640964|P2|Participant Flow|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743236|NCT01640964|P1|Participant Flow|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
743237|NCT01640964|O2|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
743238|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743239|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
743240|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743241|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743242|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743243|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743244|NCT01640964|O1|Outcome|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
743245|NCT01640964|O1|Outcome|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
743246|NCT01640964|O1|Outcome|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743247|NCT01640964|E3|Reported Event|Part B: Serelaxin (RLX030)|The patients enrolled in this part of the study received an intravenous (iv) serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min; duration of infusion depends on time required for completion of the Portal pressure gradient (PPG) data acquisition.
743248|NCT01640964|E2|Reported Event|Part A: Terlipressin Acetate|Patients received terlipressin acetate 2 mg intravenous (IV) bolus injection.
743304|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
743249|NCT01640964|E1|Reported Event|Part A: Serelaxin (RLX030)|Randomized patients received an intravenous serelaxin infusion at two different infusion rates: 80 μg/kg/day for 60 min followed by 30 μg/kg/day for at least 60 min.; duration of infusion depends on time required for completion of magnetic resonance angiography (MRA) data acquisition
743250|NCT01640925|B3|Baseline|Total|Total of all reporting groups
743251|NCT01640925|B2|Baseline|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
743252|NCT01640925|B1|Baseline|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
743253|NCT01640925|P2|Participant Flow|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
743428|NCT01639833|B1|Baseline|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
743254|NCT01640925|P1|Participant Flow|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
743255|NCT01640925|O2|Outcome|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
743256|NCT01640925|O1|Outcome|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
743257|NCT01640925|E2|Reported Event|Standard Bathing|"Upon study enrollment, patients will be bathed using standard bathing (non-medicated cloths or soap and water) daily.~Standard bathing: The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily."
743258|NCT01640925|E1|Reported Event|Chlorhexidine Gluconate Bathing|"Upon study enrollment, patients will be bathed with a 2% chlorhexidine gluconate solution on study day 1 and every 48 hours until study completion. The patient will be bathed using standard bathing (non-medicated cloths or soap and water) on study day 2 and every 48 hours after that.~Chlorhexidine gluconate: Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours"
743259|NCT01639729|B1|Baseline|Treatment A, Followed by Treatment B, C and D in Random Order|Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV) Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL) Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU) Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO) Sequence 1: A, B, C, D Sequence 2: A, B, D, C Sequence 3: A, C, B, D Sequence 4: A, C, D, B Sequence 5: A, D, B, C Sequence 6: A, D, C, B A 48-hour washout period separated each treatment period. The washout began with the start of dosing.
743260|NCT01639729|P6|Participant Flow|Sequence 6: Treatments A, D, C, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
743261|NCT01639729|P5|Participant Flow|Sequence Five: Treatments A, D, B, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
743262|NCT01639729|P4|Participant Flow|Sequence 4: Treatment A, C, D, B|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
743263|NCT01639729|P3|Participant Flow|Sequence 3: Treatment A, C, B, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
743264|NCT01639729|P2|Participant Flow|Sequence 2: A, B, D, C|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
743265|NCT01639729|P1|Participant Flow|Sequence 1: Treatment A, B, C, D|"Treatment A: Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)~Treatment B: Single Sufentanil NanoTab 15 mcg given sublingually (SL)~Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)~Treatment D: Single Sufentanil NanoTab 15 mcg swallowed (PO)~A 48-hour washout period will separate each treatment period. The washout begins with the start of dosing."
743266|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743267|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743268|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
748667|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
743269|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743270|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743271|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743272|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743273|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743274|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
754244|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
743275|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743276|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743277|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743278|NCT01639729|O4|Outcome|Sufentanil NanoTab Oral|"Sufentanil : 15 mcg oral~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743279|NCT01639729|O3|Outcome|Sufentanil NanoTab Sublingual|"Sufentanil : 15 mcg sublingual~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743280|NCT01639729|O2|Outcome|Sufentanil NanoTab Buccal|"Sufentanil : 15 mcg buccal~PK sampling 0 (predose), 10, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743281|NCT01639729|O1|Outcome|Sufentanil IV|"Sufentanil : 15 mcg IV~PK sampling 0 (predose), 1, 4, 7, 10, 15, 20, 30, 45, 60, 90, 120, 180, 240, 360, 480, 600, 720, and 840 minutes and 24 hours after dosing."
743282|NCT01639729|E4|Reported Event|Sufentanil NanoTab Oral|Sufentanil : 15 mcg oral
743283|NCT01639729|E3|Reported Event|Sufentanil NanoTab Sublingual|Sufentanil : 15 mcg sublingaul
743284|NCT01639729|E2|Reported Event|Sufentanil NanoTab Buccal|Sufentanil : 15 mcg buccal
743285|NCT01639729|E1|Reported Event|Sufentanil IV|Sufentanil : 15 mcg IV
743286|NCT01640548|B1|Baseline|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743287|NCT01640548|P1|Participant Flow|Rheumatoid Arthritis (RA) Cohort|Participants on biologic disease modifying anti-rheumatic drug (bDMARD) monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743288|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743289|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743290|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743291|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743292|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743293|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743294|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743295|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743296|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743297|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743298|NCT01640548|O1|Outcome|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743299|NCT01640548|E1|Reported Event|Rheumatoid Arthritis Cohort|Participants on bDMARD monotherapy for RA and on any RA treatment in the past were observed and data was collected retrospectively from a chart review for approximately 9 months.
743300|NCT01640353|B1|Baseline|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
743301|NCT01640353|P1|Participant Flow|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
743302|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
743303|NCT01640353|O1|Outcome|Sacroiliac Joint Fusion|SI Joint Fusion with iFuse implant system
743311|NCT01640340|B2|Baseline|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
743312|NCT01640340|B1|Baseline|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
743313|NCT01640340|P2|Participant Flow|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
743314|NCT01640340|P1|Participant Flow|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg days 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
743315|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743364|NCT01640197|B2|Baseline|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743429|NCT01639833|P2|Participant Flow|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
743316|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743317|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743318|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743319|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743320|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743321|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743322|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743323|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743324|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743325|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743326|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743327|NCT01640340|O2|Outcome|Arm B (Ondansetron 24 mg Oral on Day 1)|Ondansetron 24 mg once orally on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743328|NCT01640340|O1|Outcome|Arm A (Palonosetron 0.25 mg IV on Day 1)|Palonosetron 0.25 mg IV once on day 1, 30 minutes prior to chemotherapy, aprepitant 125 mg orally once on day 1, 60 minutes prior to chemotherapy, then 80 mg once daily on days 2 and 3 at the same time, and dexamethasone 12 mg orally once on day 1, 30 minutes prior to chemotherapy, then 8 mg once daily on days 2 through 4.
743329|NCT01640340|E2|Reported Event|Arm B|Ondansetron 24 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
743330|NCT01640340|E1|Reported Event|Arm A|Palonosetron 0.25 mg day 1; aprepitant 125 mg day 1, 80 mg day 2-3; dexamethasone 12 mg day 1, 8 mg day 2-4
743331|NCT01640327|B3|Baseline|Total|Total of all reporting groups
743332|NCT01640327|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
743333|NCT01640327|B1|Baseline|18–60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
743334|NCT01640327|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
743335|NCT01640327|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
743336|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
743337|NCT01640327|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVf vaccination
743338|NCT01640327|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIVf vaccination
743348|NCT01640314|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
743349|NCT01640314|P2|Participant Flow|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
743350|NCT01640314|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
743351|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
743352|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
743353|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
743354|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
743355|NCT01640314|O2|Outcome|≥ 61 Y|Subjects ≥61 years of age who received one TIVc vaccination
743356|NCT01640314|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIVc vaccination
743365|NCT01640197|B1|Baseline|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743366|NCT01640197|P2|Participant Flow|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743367|NCT01640197|P1|Participant Flow|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743368|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743369|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743370|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743371|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743372|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743373|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743374|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743375|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743376|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743377|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743378|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743379|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743380|NCT01640197|O2|Outcome|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743381|NCT01640197|O1|Outcome|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743382|NCT01640197|E2|Reported Event|Placebo|"Methyl Cellulose administered in identical capsules as the active.~Placebo : Methyl Cellulose. 1 capsule taken once daily for 28 days."
743383|NCT01640197|E1|Reported Event|500mg Resveratrol|"Transmax from biotivia. 500mg resveratrol (98% purity) with 10mg piperine per capsule. 1 capsule taken daily.~Resveratrol : Transmax (Biotivia). 500mg (1 capsule) per day for 28 days."
743384|NCT01640184|B4|Baseline|Total|Total of all reporting groups
743385|NCT01640184|B3|Baseline|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743386|NCT01640184|B2|Baseline|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
746434|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
743387|NCT01640184|B1|Baseline|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
743388|NCT01640184|P3|Participant Flow|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743389|NCT01640184|P2|Participant Flow|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743390|NCT01640184|P1|Participant Flow|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
754245|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
743391|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743392|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743393|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
743394|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743395|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743396|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
743397|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743398|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743399|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
743400|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743459|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
743460|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
748668|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
743401|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743402|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
743403|NCT01640184|O2|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743404|NCT01640184|O1|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743405|NCT01640184|O3|Outcome|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743406|NCT01640184|O2|Outcome|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743407|NCT01640184|O1|Outcome|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
743408|NCT01640184|E3|Reported Event|Parathyroidectomy|"Patients in parathyroidectomy group will be treated by parathyroid surgery.~Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery."
743409|NCT01640184|E2|Reported Event|Ultrasonic Ablation|"Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation.~Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively."
743410|NCT01640184|E1|Reported Event|Active Vitamin D|"Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines.~Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines."
743411|NCT01640171|B1|Baseline|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow Eye:~Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
743412|NCT01640171|P1|Participant Flow|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye Same as above plus Xylocaine 2% SC"
743413|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
743461|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
743462|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
743414|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
743415|NCT01640171|O1|Outcome|Topical Anesthesia 1 Eye, SC 1 Eye|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment at three minute intervals~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion~Fellow eye:~Same as above plus SC Xylocaine was administered following the first two topical anesthetic applications"
743416|NCT01640171|E2|Reported Event|Subconjunctival Anesthesia|"Eye receiving topical gel and subconjunctival lidocaine~Xylocaine 2% Injectable Anesthetic: xylocaine 2% injection 0.1 cc~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
743417|NCT01640171|E1|Reported Event|Topical Anesthesia|"Eye receiving only topical gel~Proparacaine Hydrochloride 0.5% Drop: Topical drop given first to the treated eye.~Tetravisc 0.5% Gel: Gel applied to eye 3 times prior to treatment~Acuvail: Anti-inflammatory drop given after treatment~Intra-vitreal Anti-VEGF Drig: Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion"
743418|NCT01640054|B1|Baseline|FOSTA 100 MG QD PO|Fostamatinib 100 mg qd
743430|NCT01639833|P1|Participant Flow|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
743431|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
743432|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
743433|NCT01639833|O2|Outcome|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
743434|NCT01639833|O1|Outcome|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
743435|NCT01639833|E2|Reported Event|TachoSil®|"Topical Hemostat~TachoSil®: Topical Hemostat"
743436|NCT01639833|E1|Reported Event|Veriset™ Hemostatic Patch|"Topical Hemostat~Veriset™ Hemostatic Patch: Topical hemostat"
743437|NCT01639755|B1|Baseline|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743438|NCT01639755|P1|Participant Flow|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743439|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743440|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743441|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743442|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743443|NCT01639755|O1|Outcome|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743444|NCT01639755|E1|Reported Event|All Participants|Al participants who had new texture shaped breast implants surgically implanted.
743445|NCT01639742|B1|Baseline|All Participants|All participants who had new texture round breast implants surgically implanted.
743446|NCT01639742|P1|Participant Flow|All Participants|All participants who had new texture round breast implants surgically implanted.
743447|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
743448|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
743449|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
743450|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
743451|NCT01639742|O1|Outcome|All Participants|All participants who had new texture round breast implants surgically implanted.
743452|NCT01639742|E1|Reported Event|All Participants|All participants who had new texture round breast implants surgically implanted.
743453|NCT01639560|B3|Baseline|Total|Total of all reporting groups
743454|NCT01639560|B2|Baseline|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
743455|NCT01639560|B1|Baseline|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
743456|NCT01639560|P2|Participant Flow|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
743457|NCT01639560|P1|Participant Flow|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
743458|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
743463|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
743464|NCT01639560|O2|Outcome|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
743465|NCT01639560|O1|Outcome|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
743466|NCT01639560|E2|Reported Event|Placebo|"1 placebo tablet twice a day for 12 weeks~Placebo: 1 placebo tablet twice per day for 12 weeks and brief behavioral counseling"
743467|NCT01639560|E1|Reported Event|Varenicline|"1 mg of varenicline twice per day for 12 weeks.~Varenicline: 1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling"
743468|NCT01639443|B3|Baseline|Total|Total of all reporting groups
743469|NCT01639443|B2|Baseline|Control|Patients who are scheduled routinely
743470|NCT01639443|B1|Baseline|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743471|NCT01639443|P2|Participant Flow|Control|Patients who are scheduled routinely
743472|NCT01639443|P1|Participant Flow|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743473|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
743474|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743475|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
743509|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743510|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743476|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743477|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
743478|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743479|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
743480|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743481|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
743482|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743483|NCT01639443|O2|Outcome|Control|Patients who are scheduled routinely
743484|NCT01639443|O1|Outcome|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743485|NCT01639443|E2|Reported Event|Control|Patients who are scheduled routinely
743486|NCT01639443|E1|Reported Event|Fast-tracked|"Patients who volunteer to enroll in fast-track line, which gives them an opportunity to overbook their appointment for endoscopy earlier in a predictive no-show slots.~Predictive no-show overbooking: During intervention period, every Veteran scheduled for an upper endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
743487|NCT01639222|B1|Baseline|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
743488|NCT01639222|P1|Participant Flow|Calcium 500 mg and Vitamin D3 800 IU|"Period 1: Low calcium meals for up to 3 days.~Period 2: Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily for up to 3 days with low calcium meals."
743489|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
743490|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
751327|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
743491|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
743492|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
743493|NCT01639222|O2|Outcome|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
743494|NCT01639222|O1|Outcome|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
743495|NCT01639222|E2|Reported Event|Reference Treatment|Period 1 (Days 1-3): 200 mL of non-carbonated water (mock treatment) with low calcium meals for up to 3 days.
743496|NCT01639222|E1|Reported Event|Calcium 500 mg and Vitamin D3 800 IU|Period 2 (Days 4-6): Calcium 500 mg and Vitamin D3 800 IU chewable tablets, orally, once daily, followed by 200 mL of non-carbonated water, for up to 3 days with low calcium meals.
743497|NCT01639157|B1|Baseline|All Study Participants|Subjects were maintained on oral buspirone (10 mg administered 3 times daily) or placebo for 6 days each during the study in random order.
743498|NCT01639157|P2|Participant Flow|Placebo Then Buspirone|Subjects were maintained on placebo daily for 6 days, then they were crossed over to 30 mg buspirone daily for 6 days.
743499|NCT01639157|P1|Participant Flow|Buspirone Then Placebo|Subjects were maintained on 30 mg buspirone daily for 6 days, then they were crossed over to placebo daily for 6 days.
743500|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743501|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743502|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743503|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743504|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743505|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743506|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743507|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743508|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743511|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743512|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743513|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743514|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743515|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743516|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743517|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743518|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743519|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743520|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743521|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743522|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743523|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743524|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743525|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743526|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743527|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743528|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743529|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743530|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743531|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743532|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743533|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743534|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743535|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743536|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743537|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743538|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743539|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743540|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743541|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743542|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743543|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743544|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743545|NCT01639157|O1|Outcome|Buspirone|Subjects were maintained on 30 mg buspirone daily for 6 days.
743546|NCT01639157|O2|Outcome|Placebo|Subjects were maintained on placebo daily for 6 days.
743554|NCT01639157|E2|Reported Event|Placebo|"Subjects will be maintained on placebo.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order.These subjects will be the same as those who are maintained on buspirone (i.e., the study uses a within-subjects design)."
743555|NCT01639157|E1|Reported Event|Buspirone|"Subjects will be maintained on buspirone.~Buspirone: Subjects will be maintained on oral buspirone (administered 3 times daily) or placebo for 6 days each during the study in random order. These subjects will be the same as those who are maintained on placebo (i.e., the study uses a within-subjects design)."
743556|NCT01639144|B3|Baseline|Total|Total of all reporting groups
743557|NCT01639144|B2|Baseline|Control|Group not receiving autogenous PRP and PPP.
743558|NCT01639144|B1|Baseline|Receiving PRP and PPP.|"Administration of PRP and PPP to surgical site.~PRP and PPP: Autogenous PRP and PPP"
743559|NCT01639144|P2|Participant Flow|Control|Group not receiving autogenous PRP and PPP.
743560|NCT01639144|P1|Participant Flow|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
743561|NCT01639144|O2|Outcome|Control|Group not receiving autogenous PRP and PPP.
743562|NCT01639144|O1|Outcome|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
743563|NCT01639144|E2|Reported Event|Control|Group not receiving autogenous PRP and PPP.
743564|NCT01639144|E1|Reported Event|Receiving PRP and PPP.|Administration of PRP and PPP to surgical site.
743565|NCT01639001|B3|Baseline|Total|Total of all reporting groups
743566|NCT01639001|B2|Baseline|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743567|NCT01639001|B1|Baseline|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743630|NCT01638468|P1|Participant Flow|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743568|NCT01639001|P2|Participant Flow|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743569|NCT01639001|P1|Participant Flow|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743570|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743571|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743572|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743573|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743574|NCT01639001|O2|Outcome|Participants With Negative ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had negative ALK FISH results.
743575|NCT01639001|O1|Outcome|Participants With Positive ALK FISH Status|Participants in the Molecular Profiling Evaluable population that had positive ALK FISH results.
743576|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743651|NCT01638312|E1|Reported Event|"HIV Infected Patients"|Serious and Other (Not Including Serious) Adverse Events were not collected
743577|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743578|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743579|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743580|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743581|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743675|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743676|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743582|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743583|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743584|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743585|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743586|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743587|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743588|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743589|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743619|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743590|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743591|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743592|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743593|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743607|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743594|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743595|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743596|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743597|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743598|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743599|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743600|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743601|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743602|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743650|NCT01638312|E2|Reported Event|"Healthy Controls"|Serious and Other (Not Including Serious) Adverse Events were not collected
743603|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743604|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743605|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743606|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743608|NCT01639001|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743609|NCT01639001|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743610|NCT01639001|E2|Reported Event|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion every 3 weeks for a maximum of 6 cycles. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered on Day 1 of a 21-day cycle at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
743611|NCT01639001|E1|Reported Event|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 21 days. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
743612|NCT01638559|B1|Baseline|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
743613|NCT01638559|P1|Participant Flow|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
743614|NCT01638559|O1|Outcome|Participants That Initiated Withdrawal|Pediatric liver transplant recipients with stable liver function tests, no evidence of rejection in the past 2 years, and at least 4 years post-transplant underwent gradual Immunosuppression withdrawal in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants were followed for 48 months ensuring a minimum of 36 months of follow-up after successful Immunosuppression withdrawal.
743615|NCT01638559|E1|Reported Event|All Screened Participants|All participants that were screened for the study.
743616|NCT01638507|B1|Baseline|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743617|NCT01638507|P1|Participant Flow|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743618|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743652|NCT01638000|B3|Baseline|Total|Total of all reporting groups
743620|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743621|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743622|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743623|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743624|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743625|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743626|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743627|NCT01638507|O1|Outcome|Primary Enrollment Group (PEG)|Patients who have one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents of less than or equal to 30 mm in length.
743628|NCT01638507|E1|Reported Event|Primary Enrollment Group (PEG)|Patients with one or two de novo lesions in native coronary arteries with a reference vessel diameter (RVD) of 2.25 mm to 4.2 mm, treated with stents less than or equal to 30 mm in length.
743629|NCT01638468|B1|Baseline|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
744789|NCT01632709|P2|Participant Flow|Dry Needling at Sympathetic Ganglion|
743631|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743632|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743633|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743634|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743635|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743636|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743637|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743638|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743639|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743640|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743641|NCT01638468|O1|Outcome|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743642|NCT01638468|E1|Reported Event|AngioJet Ultra PE Thrombectomy System|"Patients are treated with the AngioJet Ultra PE Thrombectomy System~AngioJet Ultra PE Thrombectomy System: Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System"
743643|NCT01638312|B3|Baseline|Total|Total of all reporting groups
743644|NCT01638312|B2|Baseline|"Healthy Controls"|The people didn't have infected HIV
743645|NCT01638312|B1|Baseline|"HIV Infected Patients"|The people had infected HIV
743646|NCT01638312|P2|Participant Flow|"Healthy Controls"|The people didn't have infected HIV
743647|NCT01638312|P1|Participant Flow|"HIV Infected Patients"|The people had infected HIV
743648|NCT01638312|O2|Outcome|"Healthy Controls"|"Healthy people~Graphical analysis of healthy people 1.7 of 30 healthy people were positive in waveform, and 23 were negative, the negative predictive value was 76.67%.~2.Healthy people was subjective judgments of participants, no other test as proof.~3.Graphical analysis of HIV-infected subjects"
743649|NCT01638312|O1|Outcome|"HIV Infected Patients"|20 There are six medication negative response, referring to a recent comparison of the value of the blood virus date, there are three items detected waveform error, the remaining non-medication of 14, there are two detection waveform is negative; positive predictive value = 60%
743653|NCT01638000|B2|Baseline|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743654|NCT01638000|B1|Baseline|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743655|NCT01638000|P2|Participant Flow|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743656|NCT01638000|P1|Participant Flow|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743657|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743658|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743659|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743660|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743661|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743662|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743663|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743664|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743665|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743666|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743667|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743668|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743669|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743670|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743671|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743672|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743673|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743674|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
744790|NCT01632709|P1|Participant Flow|Sympathetic Nerve Block of Bupivacaine|
743677|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743678|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743679|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743680|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743681|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743682|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743683|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743684|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743685|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743686|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743687|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743688|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743689|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743690|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743691|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743692|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743693|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743694|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743695|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743696|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743697|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743698|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743699|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743700|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743701|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743702|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743703|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743704|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743705|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743706|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743707|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743708|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743709|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743710|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743711|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743712|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743713|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743714|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743715|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743716|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743717|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743718|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743719|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743720|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743721|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743722|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743723|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743724|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743725|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743726|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743727|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743728|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743729|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743730|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743731|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743732|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743733|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743734|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743735|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743736|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743737|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743738|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743739|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743740|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743741|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743742|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743743|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743744|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743745|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743746|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743747|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743748|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743749|NCT01638000|O2|Outcome|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743750|NCT01638000|O1|Outcome|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743751|NCT01638000|E2|Reported Event|Solifenacin 5 mg|Participants who received solifenacin 5 mg once daily for 12 weeks.
743752|NCT01638000|E1|Reported Event|Mirabegron 50 mg|Participants who received mirabegron 50 mg once daily for 12 weeks.
743753|NCT01637961|B1|Baseline|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
743754|NCT01637961|P1|Participant Flow|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
743755|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
743756|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
743757|NCT01637961|O1|Outcome|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
743758|NCT01637961|E1|Reported Event|MLN8237|MLN8237, 50 mg, taken by mouth twice daily on Days 1-7. One cycle is 3 weeks long (21 days). CT or MRI imaging for response every other cycle (every 6 weeks). Treatment may continue until disease progression or adverse effects prohibit further therapy.
743759|NCT01637935|B3|Baseline|Total|Total of all reporting groups
743760|NCT01637935|B2|Baseline|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743762|NCT01637935|P2|Participant Flow|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743763|NCT01637935|P1|Participant Flow|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
743764|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743765|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
743766|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743767|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
743768|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743769|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
743770|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743771|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
743772|NCT01637935|O2|Outcome|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743773|NCT01637935|O1|Outcome|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
743774|NCT01637935|E2|Reported Event|Pioglitazone Unexposed Group|Patients never exposed to pioglitazone.
743775|NCT01637935|E1|Reported Event|Pioglitazone Exposed Group|Patients ever exposed to pioglitazone.
743776|NCT01637922|B3|Baseline|Total|Total of all reporting groups
743777|NCT01637922|B2|Baseline|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743778|NCT01637922|B1|Baseline|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743779|NCT01637922|P2|Participant Flow|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
743780|NCT01637922|P1|Participant Flow|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): Oral dose of BI 201335(faldaprevir) 480 mg on day 2 and 240 mg twice daily for days 3 to 9."
743781|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
754246|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
743782|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743783|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743784|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743785|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743786|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743787|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743788|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743789|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743790|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743791|NCT01637922|O1|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743792|NCT01637922|O2|Outcome|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743793|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743794|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743795|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743796|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743797|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743798|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743799|NCT01637922|O1|Outcome|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743800|NCT01637922|E2|Reported Event|Buprenorphine/Naloxone (Suboxone)|"patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743801|NCT01637922|E1|Reported Event|Methadone Group|"patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day. Days 1-13.~BI 201335(faldaprevir): BI 201335(faldaprevir) for days 3 to 9."
743802|NCT01637584|B3|Baseline|Total|Total of all reporting groups
743803|NCT01637584|B2|Baseline|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743804|NCT01637584|B1|Baseline|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743805|NCT01637584|P2|Participant Flow|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743806|NCT01637584|P1|Participant Flow|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743807|NCT01637584|O2|Outcome|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743852|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743853|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
744791|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
743808|NCT01637584|O1|Outcome|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743809|NCT01637584|O1|Outcome|Prazosin -Placebo|Difference in relative brain glucose metabolism between states and pre-to-post treatment for participants randomized to prazosin after adjusting for non-significant changes in the placebo group.
743810|NCT01637584|E2|Reported Event|Placebo|"A placebo is a sugar pill, which will be used to compare with the results of the active medication~Placebo: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743811|NCT01637584|E1|Reported Event|Prazosin|"Active medication arm. Prazosin is an FDA approved medication, originally designed as an anti-hypertension medication. Side effects of the medication in some include sleepiness and once asleep, sustained sleep.~Prazosin: The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking."
743812|NCT01637272|B1|Baseline|SOM230|Subjects with dumping syndrome treated with pasireotide
743813|NCT01637272|P1|Participant Flow|SOM230|Subjects with dumping syndrome treated with pasireotide
743814|NCT01637272|O4|Outcome|SOM LAR 40mg|Subjects with dumping syndrome treated with pasireotide LAR 40mg
743815|NCT01637272|O3|Outcome|SOM LAR 30mg|Subjects with dumping syndrome treated with pasireotide LAR 30mg
743816|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
743817|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
743818|NCT01637272|O5|Outcome|SOM LAR 60mg|Subjects with dumping syndrome treated with pasireotide LAR 60mg
743819|NCT01637272|O4|Outcome|SOM LAR 40mg|Subjects with dumping syndrome treated with pasireotide LAR 40mg
743820|NCT01637272|O3|Outcome|SOM LAR 30mg|Subjects with dumping syndrome treated with pasireotide LAR 30mg
743821|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
743822|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
743823|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
743824|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
743825|NCT01637272|O2|Outcome|SOM LAR 20mg|Subjects with dumping syndrome treated with pasireotide LAR 20mg
743826|NCT01637272|O1|Outcome|SOM LAR 10mg|Subjects with dumping syndrome treated with pasireotide LAR 10mg
743827|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
743828|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
743829|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
743830|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
743831|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
743832|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
743833|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
743834|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
743835|NCT01637272|O4|Outcome|SOM sc 200 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 200 ug t.i.d.
743836|NCT01637272|O3|Outcome|SOM sc 150 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 150 ug t.i.d. for 3 months
743837|NCT01637272|O2|Outcome|SOM sc 100 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 100 ug t.i.d. for 3 months
743838|NCT01637272|O1|Outcome|SOM sc 50 ug t.i.d.|Subjects with dumping syndrome treated with pasireotide sc 50 ug t.i.d. for 3 months
743839|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743840|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743841|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743842|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743843|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743844|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743845|NCT01637272|O3|Outcome|SOM230 - 8 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743846|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743847|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743848|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743849|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743850|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743851|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
754247|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
743854|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743855|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743856|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743857|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743858|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743859|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743860|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743861|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743862|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743863|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743864|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743865|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743866|NCT01637272|O3|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743867|NCT01637272|O2|Outcome|SOM230 - 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M) followed by pasireotide LAR (3M) for a total of 6 months
743868|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743869|NCT01637272|O2|Outcome|SOM230 - 12 Months (Ext)|Subjects with dumping syndrome treated with pasireotide LAR (6 months in Core & 6 months in Ext. phase)
743870|NCT01637272|O1|Outcome|SOM230- 6 Months (LAR)|Subjects with dumping syndrome treated with pasireotide sc (3M)followed by pasireotide LAR (3M) for a total of 6 months
743871|NCT01637272|O1|Outcome|SOM230 - 3 Months (sc)|Subjects with dumping syndrome treated with pasireotide sc
743872|NCT01637272|E2|Reported Event|LAR Phase|LAR phase was made up of subjects with dumping syndrome who completed the s.c. phase, entered the LAR phase and were treated with pasireotide LAR
743873|NCT01637272|E1|Reported Event|s.c. Phase|s.c. phase was made up of subjects with dumping syndrome who entered the study and were treated with pasireotide s.c.
743874|NCT01637246|B1|Baseline|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743875|NCT01637246|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743876|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743877|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743878|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743879|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743880|NCT01637246|O1|Outcome|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743881|NCT01637246|E1|Reported Event|POAG or OHT|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy
743882|NCT01637090|B1|Baseline|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743883|NCT01637090|P1|Participant Flow|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743884|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743907|NCT01636947|B1|Baseline|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743885|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743886|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743887|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743888|NCT01637090|O1|Outcome|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743889|NCT01637090|E1|Reported Event|All Patients on Study|"Prospective, phase II non-randomized, open label study of single agent everolimus for the treatment of CTCL recurrent or refractory to at least one previous treatment other than topical medication. The purpose will be evaluation of safety and anti-tumor response as evaluated by serial skin examinations and assessment of tumor burden in tissue and blood.~This study will be conducted in 2 stages. During stage 1 we will enroll a maximum of 11 subjects to evaluate response rate and will only continue to stage 2, if we observe two or more responses. During stage 2, we will expand the study to an overall N of 28 patients.~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity."
743890|NCT01636986|B3|Baseline|Total|Total of all reporting groups
743891|NCT01636986|B2|Baseline|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
743892|NCT01636986|B1|Baseline|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
743893|NCT01636986|P2|Participant Flow|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
743894|NCT01636986|P1|Participant Flow|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
743895|NCT01636986|O2|Outcome|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
746435|NCT01623050|E1|Reported Event|SinuSys Dilation System|Maxillary Sinus Dilation
743896|NCT01636986|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
743897|NCT01636986|E2|Reported Event|1DAVM|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
743898|NCT01636986|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 4 weeks
743899|NCT01636960|B1|Baseline|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
743900|NCT01636960|P1|Participant Flow|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
743901|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
743902|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
743903|NCT01636960|O1|Outcome|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
743904|NCT01636960|E1|Reported Event|Participants Receiving PegIFN Alfa-2b|Participants received PegIFN alfa-2b 6 µg/kg subcutaneously (SC) on Day 1 of each week for 8 weeks (Induction) and then 3 µg/kg SC once weekly for up to 252 weeks (Maintenance).
743905|NCT01636947|B3|Baseline|Total|Total of all reporting groups
743906|NCT01636947|B2|Baseline|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
744792|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
743908|NCT01636947|P2|Participant Flow|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743909|NCT01636947|P1|Participant Flow|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule by mouth (PO) once daily (QD) on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg intravenously (IV) QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO twice daily (BID) on Days 2 and 3.
743910|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743911|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743912|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743913|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743914|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743915|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743916|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743917|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743918|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743919|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743920|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743921|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743922|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743923|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743924|NCT01636947|O2|Outcome|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743925|NCT01636947|O1|Outcome|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743926|NCT01636947|E2|Reported Event|Control Regimen|Participants receive one placebo capsule PO QD on Day 1 and one placebo capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 20 mg PO on Day 1 and ondansetron 8 mg PO BID on Days 2 and 3.
743927|NCT01636947|E1|Reported Event|Aprepitant Regimen|Participants receive one aprepitant 125 mg capsule PO QD on Day 1 and one aprepitant 80 mg capsule PO QD on Days 2 and 3 of Cycle 1. Participants also receive ondansetron 16 mg IV QD and dexamethasone 12 mg PO on Day 1 and placebo for ondansetron 8 mg PO BID on Days 2 and 3.
743928|NCT01636778|B1|Baseline|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743929|NCT01636778|P3|Participant Flow|Eltrombopag + Antiviral Therapy: Follow-up Period After Part|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
744793|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
743930|NCT01636778|P2|Participant Flow|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743931|NCT01636778|P1|Participant Flow|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743932|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743933|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743934|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743935|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743936|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743937|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743938|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
744010|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
746436|NCT01622673|B7|Baseline|Total|Total of all reporting groups
743939|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743940|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743941|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743942|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743943|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743944|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743945|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743946|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743947|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743948|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743949|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743950|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743951|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743952|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743953|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
744011|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
743954|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743955|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743956|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743957|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743958|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743959|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743960|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743961|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743962|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743963|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743964|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743965|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743966|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743967|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743968|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
744012|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
747387|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
743969|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743970|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743971|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743972|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743973|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743974|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743975|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743976|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743977|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743978|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743979|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743980|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743981|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743982|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743983|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743984|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
744013|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
744014|NCT01636713|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
743985|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743986|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743987|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743988|NCT01636778|O1|Outcome|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
744029|NCT01636466|B2|Baseline|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
743989|NCT01636778|O1|Outcome|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of <80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained <100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743990|NCT01636778|E3|Reported Event|Eltrombopag + Antiviral Therapy: Follow-up Period After Part 2|Participants who completed therapy or had early termination in Part 2 had three post-treatment follow-up visits at 4 weeks, 12 weeks and 24 weeks after the end or withdrawal of study treatment.
743991|NCT01636778|E2|Reported Event|Eltrombopag + Antiviral Therapy: Part 2|Participants completing Part 1 continued on the same dose of eltrombopag received in Part 1 (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (Peg-IFN alfa-2a/RBV or Peg-IFN alfa-2b/RBV) for a duration of 48 weeks. Dose adjustments of eltrombobag were permitted up to 50mg QD in order to maintain an appropriate platelet count.
743992|NCT01636778|E1|Reported Event|Eltrombopag Dose Escalation: Part 1|Participants with an initial platelet count of &lt;80 Gi/L, received eltrombopag at 12.5 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 25 mg QD (up to 2 weeks). If platelet counts still remained &lt;100 Gi/L, further dose escalations to 37.5 mg QD (up to 2 weeks) and 50 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during Part1 (maximum of up to 9 weeks) were eligible to enter the Antiviral Treatment Period (Part 2), whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and progressed to the Follow-up Period.
743993|NCT01636765|B1|Baseline|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
743994|NCT01636765|P1|Participant Flow|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
743995|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
743996|NCT01636765|O1|Outcome|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
743997|NCT01636765|E1|Reported Event|All Participants|Patients with facial erythema associated with rosacea. There was no intervention in this study.
743998|NCT01636713|B4|Baseline|Total|Total of all reporting groups
743999|NCT01636713|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
744000|NCT01636713|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
744001|NCT01636713|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
744002|NCT01636713|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
744003|NCT01636713|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
744004|NCT01636713|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
744005|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
744006|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
744007|NCT01636713|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
744008|NCT01636713|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
744009|NCT01636713|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
751593|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
744015|NCT01636713|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide (UMEC)/vilanterol (VI) 62.5/25 micrograms (µg) QD via a DPI in the morning for 24 weeks.
744016|NCT01636713|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
744017|NCT01636661|B3|Baseline|Total|Total of all reporting groups
744018|NCT01636661|B2|Baseline|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744019|NCT01636661|B1|Baseline|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744020|NCT01636661|P2|Participant Flow|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744021|NCT01636661|P1|Participant Flow|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744022|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744023|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744024|NCT01636661|O2|Outcome|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744025|NCT01636661|O1|Outcome|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744026|NCT01636661|E2|Reported Event|Sham tDCS|"tDCS equipment set to placebo setting.~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744027|NCT01636661|E1|Reported Event|Transcranial Direct Current Stimulation|"Receiving active tDCS~tDCS: transcranial direct current stimulation- non-invasive brain stimulation"
744028|NCT01636466|B3|Baseline|Total|Total of all reporting groups
744030|NCT01636466|B1|Baseline|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
744031|NCT01636466|P2|Participant Flow|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
744032|NCT01636466|P1|Participant Flow|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
744033|NCT01636466|O2|Outcome|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
744034|NCT01636466|O1|Outcome|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
744035|NCT01636466|E2|Reported Event|Control|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to continue on current immunosuppressive regimen. Subjects were weaned off of all immunosuppression medicines when dialysis started.
744036|NCT01636466|E1|Reported Event|Everolimus Conversion|Subjects who have previously undergone a kidney transplant and were in late stage renal allograft failure were randomized to take everolimus at least 0.75 mg twice daily after discontinuing current calcineurin inhibitor. Subjects were weaned off of all other immunosuppression medicines when dialysis started.
744037|NCT01636414|B4|Baseline|Total|Total of all reporting groups
744038|NCT01636414|B3|Baseline|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
744039|NCT01636414|B2|Baseline|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
744040|NCT01636414|B1|Baseline|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
744041|NCT01636414|P3|Participant Flow|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
744042|NCT01636414|P2|Participant Flow|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
744043|NCT01636414|P1|Participant Flow|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
744044|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
744045|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
744046|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
744047|NCT01636414|O3|Outcome|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
744048|NCT01636414|O2|Outcome|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
744049|NCT01636414|O1|Outcome|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
751690|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
744050|NCT01636414|E3|Reported Event|Tranexamic Drain|Tranexamic drain: Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
744051|NCT01636414|E2|Reported Event|Re-infusion Drain|Re-infusion drain: This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
744052|NCT01636414|E1|Reported Event|Hemovac Drain|Hemovac drain: The Hemovac drain is a device placed under your skin used to collect blood during surgery.
744053|NCT01636362|B1|Baseline|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
744054|NCT01636362|P1|Participant Flow|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
744055|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
744056|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
744057|NCT01636362|O1|Outcome|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
744109|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
744110|NCT01636076|O1|Outcome|QMF149 Analyte: Mometasone Furoate|Mometasone furoate as part of QMF149F
744058|NCT01636362|E1|Reported Event|Mepitel Ag|"Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.~Mepitel Ag: Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues."
744059|NCT01636258|B3|Baseline|Total|Total of all reporting groups
744060|NCT01636258|B2|Baseline|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
744061|NCT01636258|B1|Baseline|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744062|NCT01636258|P2|Participant Flow|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
744063|NCT01636258|P1|Participant Flow|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744064|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
744065|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744066|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
744067|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744068|NCT01636258|O2|Outcome|Arm B|"Arm includes diet instruction, exercise, stress management, and culinary education~Stress Management: Every other week~Diet: Every other week~Exercise: Every week~Culinary education: Every other week"
744069|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744070|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
744071|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744072|NCT01636258|O2|Outcome|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
744073|NCT01636258|O1|Outcome|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744074|NCT01636258|E2|Reported Event|Arm B: Intervention Group|"Arm includes diet instruction, exercise, stress management, and culinary education~Exercise : Every week~Diet : Every other week~Culinary education : Every other week~Stress Management : Every other week"
744075|NCT01636258|E1|Reported Event|Arm A: Control Group|These participants will continue to receive their usual care from their primary medical care team.
744076|NCT01636206|B3|Baseline|Total|Total of all reporting groups
744077|NCT01636206|B2|Baseline|Lifitegrast|
744078|NCT01636206|B1|Baseline|Placebo|
744079|NCT01636206|P2|Participant Flow|Lifitegrast|
744080|NCT01636206|P1|Participant Flow|Placebo|
744081|NCT01636206|O2|Outcome|Lifitegrast|
744082|NCT01636206|O1|Outcome|Placebo|
744083|NCT01636206|E2|Reported Event|Lifitegrast|
744084|NCT01636206|E1|Reported Event|Placebo|
744085|NCT01636102|B3|Baseline|Total|Total of all reporting groups
744086|NCT01636102|B2|Baseline|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
744087|NCT01636102|B1|Baseline|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
744088|NCT01636102|P2|Participant Flow|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
744089|NCT01636102|P1|Participant Flow|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
744091|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
744092|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
744093|NCT01636102|O1|Outcome|18 - 60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
744094|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
744095|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
744096|NCT01636102|O2|Outcome|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
744097|NCT01636102|O1|Outcome|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
744098|NCT01636102|E2|Reported Event|≥61 Y|Subjects ≥61 years of age who received one TIV vaccination
744099|NCT01636102|E1|Reported Event|18-60 Y|Subjects ≥18 years to ≤60 years of age who received one TIV vaccination
744100|NCT01636076|B3|Baseline|Total|Total of all reporting groups
744101|NCT01636076|B2|Baseline|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744102|NCT01636076|B1|Baseline|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744103|NCT01636076|P2|Participant Flow|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744104|NCT01636076|P1|Participant Flow|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744105|NCT01636076|O2|Outcome|QMF149 Analyte QAB149|QMF149 analyte QAB149 ( indacaterol acetate)
744106|NCT01636076|O1|Outcome|QMF149 Analyte Mometasone Furoate|QMF149 Mometasone furoate analyte from mixture
744107|NCT01636076|O2|Outcome|QMF149 Analyte: Indacaterol Acetate|QAB149: indacaterol acetate as a component of QMF149F
744108|NCT01636076|O1|Outcome|QMF 149 Anaylyte: Mometasone Furorate|Mometasone furoate as a component of QMF149F
744111|NCT01636076|O2|Outcome|QMF149 (Analyte Indacaterol Acetate)|Assay Analyte: QAB149 (Indacaterol acetate), component of QMF 149 mixture
744112|NCT01636076|O1|Outcome|QMF149 (Analyte Mometasone Furoate)|Assay Analyte: MOMETASONE FUROATE, component of QMF 149 mixture
744113|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744114|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744115|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744116|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744117|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744118|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744119|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744120|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744121|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744122|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744123|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744124|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744125|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744126|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744127|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744128|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744129|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744130|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744131|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744132|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744133|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744134|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744135|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744136|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744137|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744138|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744139|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744140|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744141|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744142|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744143|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744144|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744145|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744146|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744147|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744148|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744149|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744150|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744151|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744152|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744153|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744154|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744155|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744156|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744157|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744158|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744159|NCT01636076|O2|Outcome|Salmeterol Xinafoate/Fluticasone Propionate|Salmeterol xinafoate/fluticasone propionate 50/500 µg b.i.d, delivered via Accuhaler®
744160|NCT01636076|O1|Outcome|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744161|NCT01636076|E2|Reported Event|SALM/FLUT|SALM/FLUT
744162|NCT01636076|E1|Reported Event|QMF149|QMF149 (Indacaterol acetate/Mometasone furoate) 150/160 µg o.d. delivered via Concept1 device
744163|NCT01636063|B3|Baseline|Total|Total of all reporting groups
744164|NCT01636063|B2|Baseline|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
744165|NCT01636063|B1|Baseline|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
744166|NCT01636063|P2|Participant Flow|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
744167|NCT01636063|P1|Participant Flow|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
744168|NCT01636063|O2|Outcome|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
744169|NCT01636063|O1|Outcome|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
744170|NCT01636063|E2|Reported Event|Misoprostol|"Subjects will receive 400 mcg of buccal misoprostol for the purposes of cervical preparation.~Misoprostol: Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure"
744171|NCT01636063|E1|Reported Event|Mifepristone|"Subjects will receive 200 mg of capsulized mifepristone orally for the purpose of cervical preparation before surgical abortion~Mifepristone: Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure"
744172|NCT01635933|B3|Baseline|Total|Total of all reporting groups
744173|NCT01635933|B2|Baseline|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744174|NCT01635933|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744175|NCT01635933|P2|Participant Flow|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744176|NCT01635933|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744177|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744178|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744179|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744180|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744181|NCT01635933|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744182|NCT01635933|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744183|NCT01635933|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A contact lens with color worn in daily wear modality for 4 weeks, with a replacement pair dispensed at 14 days. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744184|NCT01635933|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn in daily wear modality for 4 weeks. Lenses were worn bilaterally for a minimum of 5 days per week, 8 hours per day.
744185|NCT01635920|B3|Baseline|Total|Total of all reporting groups
744186|NCT01635920|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744187|NCT01635920|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744188|NCT01635920|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744189|NCT01635920|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744190|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744191|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with print worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
754248|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
744192|NCT01635920|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744193|NCT01635920|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744194|NCT01635920|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lens worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744195|NCT01635920|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lens with color worn bilaterally for a minimum of 5 days per week, 8 hours per day, in daily wear modality for 4 weeks.
744196|NCT01635881|B1|Baseline|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
744197|NCT01635881|P1|Participant Flow|Emerge|Single arm with investigational Emerge™ 1.20 mm percutaneous transluminal coronary angioplasty (PTCA) Dilatation Catheter
744198|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
744199|NCT01635881|O1|Outcome|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
744200|NCT01635881|E1|Reported Event|Emerge|Single arm with investigational Emerge™ 1.20 mm PTCA Dilatation Catheter
744201|NCT01635855|B1|Baseline|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
744202|NCT01635855|P1|Participant Flow|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
744203|NCT01635855|O1|Outcome|Belotero|Belotero®: Hyaluronic acid dermal filler
744204|NCT01635855|E1|Reported Event|Belotero®: Hyaluronic Acid Dermal Filler|Belotero®: Hyaluronic acid dermal filler
744205|NCT01635504|B1|Baseline|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
744206|NCT01635504|P1|Participant Flow|Botulinum Toxin A|Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
744207|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
744208|NCT01635504|O1|Outcome|HIV Posterior Cheek Enlargement Group|Patients with HIV posterior cheek enlargement treated with botulinum toxin A
744209|NCT01635504|E1|Reported Event|HIV Posterior Cheek Enlargement Group|Injected with botulinum toxin A
744210|NCT01635439|B3|Baseline|Total|Total of all reporting groups
744211|NCT01635439|B2|Baseline|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744212|NCT01635439|B1|Baseline|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744213|NCT01635439|P2|Participant Flow|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744214|NCT01635439|P1|Participant Flow|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744215|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744216|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744217|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744218|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744219|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744220|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744221|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744222|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744223|NCT01635439|O2|Outcome|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744224|NCT01635439|O1|Outcome|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744225|NCT01635439|E2|Reported Event|Prostin E2|PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
744226|NCT01635439|E1|Reported Event|Propess|Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h over 12 h.
744227|NCT01635244|B4|Baseline|Total|Total of all reporting groups
744228|NCT01635244|B3|Baseline|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744229|NCT01635244|B2|Baseline|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744230|NCT01635244|B1|Baseline|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744231|NCT01635244|P3|Participant Flow|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744232|NCT01635244|P2|Participant Flow|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744233|NCT01635244|P1|Participant Flow|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744234|NCT01635244|O3|Outcome|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744235|NCT01635244|O2|Outcome|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744236|NCT01635244|O1|Outcome|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744237|NCT01635244|E3|Reported Event|Trifecta|"Aortic valve replacement will be performed with a Trifecta aortic bioprosthesis (St. Jude Medical; St. Paul, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744238|NCT01635244|E2|Reported Event|Magna Ease|"Aortic valve replacement will be performed with a Magna Ease aortic bioprosthesis (Edwards Lifesciences; Irvine, CA).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744239|NCT01635244|E1|Reported Event|Freestyle|"Aortic valve replacement will be performed with a Freestyle stentless aortic bioprosthesis (Medtronic Cardiovascular; Minneapolis, MN).~Aortic valve replacement: Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta)."
744240|NCT01635218|B4|Baseline|Total|Total of all reporting groups
744241|NCT01635218|B3|Baseline|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744242|NCT01635218|B2|Baseline|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
744243|NCT01635218|B1|Baseline|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744244|NCT01635218|P3|Participant Flow|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744245|NCT01635218|P2|Participant Flow|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
744246|NCT01635218|P1|Participant Flow|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744247|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744248|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
744249|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744250|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744251|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
744252|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744253|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744254|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
744255|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744256|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744257|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
744258|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744259|NCT01635218|O3|Outcome|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744260|NCT01635218|O2|Outcome|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4."
744261|NCT01635218|O1|Outcome|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744373|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744262|NCT01635218|E3|Reported Event|Placebo|"Fluoxetine placebo plus individualized homeopathic placebo~Placebo: Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4."
744263|NCT01635218|E2|Reported Event|Fluoxetine|"Selective serotonin reuptake inhibitor.~Fluoxetine: 20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded could be repeated at week 4."
744264|NCT01635218|E1|Reported Event|Individualized Homeopathic Treatment|"Selection of the individualized homeopathic remedy based on Hahnemann´s methodology after the case history of each patient.~Individualized homeopathic treatment: A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms."
744265|NCT01635062|B3|Baseline|Total|Total of all reporting groups
744266|NCT01635062|B2|Baseline|Placebo|"Subjects will receive placebo for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
744267|NCT01635062|B1|Baseline|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
744268|NCT01635062|P2|Participant Flow|Placebo|"Subjects will receive placebo for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
744269|NCT01635062|P1|Participant Flow|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Subjects have their renin-angiotensin system, renal plasma flow, and urine protein assessed at baseline while sodium restricted and sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat assessments again while sodium restricted and sodium loaded."
744270|NCT01635062|O2|Outcome|Placebo|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
744271|NCT01635062|O1|Outcome|Calcitriol|Subjects have their urine protein assessed at baseline while sodium sodium loaded and again following 3 weeks of randomization to calcitriol (up to 0.75 mcg daily) or placebo.
744272|NCT01635062|O2|Outcome|Placebo|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
744273|NCT01635062|O1|Outcome|Calcitriol|Subjects have their renal plasma flow assessed at baseline while sodium loaded. They will then be randomized to receive calcitriol (up to 0.75 mcg daily) or placebo for 3 weeks, and repeat renal plasma flow assessments again while sodium loaded.
744274|NCT01635062|O2|Outcome|Placebo|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
744275|NCT01635062|O1|Outcome|Calcitriol|Subjects have their plasma renin activity assessed at baseline while sodium restricted, and again after 2 weeks of randomized therapy with calcitriol (up to 0.75 mcg daily) or placebo.
744276|NCT01635062|E2|Reported Event|Placebo|"Subjects will receive placebo for 3 weeks.~Placebo: Subjects will receive placebo for 3 weeks."
744277|NCT01635062|E1|Reported Event|Calcitriol|"Subjects will receive calcitriol (titrated up to 0.75 mcg daily) for 3 weeks.~Calcitriol: Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks."
744278|NCT01634659|B3|Baseline|Total|Total of all reporting groups
744279|NCT01634659|B2|Baseline|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
744280|NCT01634659|B1|Baseline|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
744281|NCT01634659|P2|Participant Flow|Narafilcon B, Then Delefilcon A|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn first, followed by delefilcon A contact lenses (DAILIES TOTAL1®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
744282|NCT01634659|P1|Participant Flow|Delefilcon A, Then Narafilcon B|Delefilcon A contact lenses (DAILIES TOTAL1®) worn first, followed by narafilcon B contact lenses (1-DAY ACUVUE® TruEye®). Each product was worn bilaterally (ie, in both eyes) in a daily wear, daily disposable mode for 8 days.
744283|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744284|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744285|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744286|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744287|NCT01634659|O2|Outcome|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744288|NCT01634659|O1|Outcome|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744289|NCT01634659|E2|Reported Event|Narafilcon B|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744290|NCT01634659|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses (DAILIES TOTAL1®) worn bilaterally in a daily wear, daily disposable mode for 8 days in either Period 1 or Period 2
744291|NCT01634620|B1|Baseline|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744292|NCT01634620|P1|Participant Flow|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744293|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744294|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
754249|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
744295|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
744296|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
744297|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
744298|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
744299|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
744300|NCT01634620|O3|Outcome|High FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements was performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~High FeNO subjects are defined as subjects with FeNO levels > 50 parts per billion."
744301|NCT01634620|O2|Outcome|Moderate FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Moderate FeNO is defined as subjects with FeNO levels >=25 parts per billion (ppb) or <=50 ppb."
744302|NCT01634620|O1|Outcome|Low FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011).~Low FeNo is defined as subjects with FeNo levels <25 parts per billion."
744374|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
751691|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
744303|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) had a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements were performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744304|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744305|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744306|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744381|NCT01634165|P2|Participant Flow|0.6 U/kg LY, 0.6 U/kg Lantus, 0.3 U/kg LY, 0.3 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg Lantus during Period 2; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
744307|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744308|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744309|NCT01634620|O1|Outcome|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744310|NCT01634620|E1|Reported Event|FeNO|"Participants with chronic obstructive pulmonary disease (COPD) will have a fractional exhaled nitric oxide (FeNO) measurement taken by NIOX MINO® Instrument (09-1100) according to the 'Perform FeNO Measurement' guidelines on page 7 of the NIOX MINO® User Manual (February 2011) during their study visit.~NIOX MINO® Instrument (09-1100) : FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
744311|NCT01634555|B1|Baseline|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
744312|NCT01634555|P1|Participant Flow|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 milligrams per kilogram (mg/kg) administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 milligrams per square meter (mg/m²) administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each 2-week cycle"
744313|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
744314|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
744315|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
744316|NCT01634555|O1|Outcome|Ramucirumab + FOLFIRI (Cycle 2)|"Ramucirumab (IMC-1121B): 8 mg/kg administered as IV infusion on Day 1 of Cycle 2 (2-week cycle)~Irinotecan: 180 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of both Cycles 1 and 2 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of Cycles 1 and 2, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of both Cycles 1 and 2 (2-week cycle)"
748367|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
744317|NCT01634555|O1|Outcome|FOLFIRI (Cycle 1)|"Irinotecan: 180 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~Folinic acid: 400 mg/m² administered IV on Day 1 of Cycle 1 (2-week cycle)~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of Cycle 1 (2-week cycle)"
744318|NCT01634555|E1|Reported Event|Ramucirumab (IMC-1121B) and FOLFIRI|"Treatment is sequential. Ramucirumab (IMC-1121B) was administered before FOLFIRI (Irinotecan + Folinic acid + 5-Fluorouracil) during Cycles 2+~Ramucirumab (IMC-1121B): 8 mg/kg, administered as IV infusion on Day 1 of each 2-week cycle (except Cycle 1)~Irinotecan: 180 mg/m² administered IV on Day 1 of each 2-week cycle~Folinic acid: 400 mg/m² administered IV on Day 1 of each 2-week cycle~5-Fluorouracil: 400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each 2-week cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle"
744319|NCT01634360|B3|Baseline|Total|Total of all reporting groups
744320|NCT01634360|B2|Baseline|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744384|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744321|NCT01634360|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744322|NCT01634360|P2|Participant Flow|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744323|NCT01634360|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744324|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744325|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744326|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744327|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744328|NCT01634360|O2|Outcome|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744375|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744376|NCT01634243|E2|Reported Event|Advanced Parkinson's Disease|
744377|NCT01634243|E1|Reported Event|Early-stage Parkinson's Disease|
744329|NCT01634360|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744330|NCT01634360|E2|Reported Event|Perampanel (Perampanel 0.5, 1, or 2 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744382|NCT01634165|P1|Participant Flow|0.3 U/kg LY, 0.6 U/kg LY, 0.3 U/kg Lantus, 0.6 U/kg Lantus|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during Period 1; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.3 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg Lantus during Period 4. There was a minimum washout interval of 6 days between each period.
744331|NCT01634360|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-E044-204). Subjects started on perampanel 1mg once daily for 4 weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. There were at least 2 weeks between each titration to assess safety and tolerability, and the subjects attended a clinic visit for safety review and dispensing of more medication. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
744332|NCT01634256|B3|Baseline|Total|Total of all reporting groups
744333|NCT01634256|B2|Baseline|Placebo|
744334|NCT01634256|B1|Baseline|Fermented Curcuma|
744335|NCT01634256|P2|Participant Flow|Placebo|"Placebo(3times/day, 6capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Fermented turmeric."
744336|NCT01634256|P1|Participant Flow|Fermented Turmeric|"Fermented turmeric(3times/day, 6capsules/day, 3g/day) for 12weeks~Fermented curcuma : Powdered Curcuma longa L., was produced through the fermentation of Aspergillus oryzae to 25 ˚ C for 36 hours."
744337|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
744338|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
744339|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
744340|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
744341|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
744342|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
744343|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
744344|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
744345|NCT01634256|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
744346|NCT01634256|O1|Outcome|Fermented Turmeric|Oral intake Fermented turmeric (3.0g/day) for 12weeks.
744347|NCT01634256|E2|Reported Event|Placebo|Oral intake placebo(3.0g/day) for 12weeks
744348|NCT01634256|E1|Reported Event|Fermented Curcuma|Oral intake fermented curcuma (3.0g/day) for 12weeks.
744349|NCT01634243|B3|Baseline|Total|Total of all reporting groups
744350|NCT01634243|B2|Baseline|Advanced Parkinson's Disease|
744351|NCT01634243|B1|Baseline|Early-stage Parkinson's Disease|
744352|NCT01634243|P2|Participant Flow|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744353|NCT01634243|P1|Participant Flow|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744354|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744355|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744356|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744357|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744358|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744359|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744360|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744361|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744362|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744363|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744364|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744365|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744366|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744367|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744368|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744369|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744370|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744371|NCT01634243|O1|Outcome|Early-stage Parkinson's Disease|Subjects with early Parkinson's disease received SPM 962 transdermal patch
744372|NCT01634243|O2|Outcome|Advanced Parkinson's Disease|Subjects with advanced Parkinson's disease received SPM 962 transdermal patch
744378|NCT01634165|B1|Baseline|All Participants|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016, or 0.6 U/kg LY2963016, or 0.3 U/kg Lantus, or 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744379|NCT01634165|P4|Participant Flow|0.6 U/kg Lantus, 0.3 U/kg Lantus, 0.6 U/kg LY, 0.3 U/kg LY|Single subcutaneous dose of 0.6 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg Lantus during Period 2; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 3; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
744380|NCT01634165|P3|Participant Flow|0.3 U/kg Lantus, 0.3 U/kg LY, 0.6 U/kg Lantus, 0.6 U/kg LY|Single subcutaneous dose of 0.3 U/kg Lantus during Period 1; Single subcutaneous dose of 0.3 U/kg LY2963016 during Period 2; Single subcutaneous dose of 0.6 U/kg Lantus during Period 3; Single subcutaneous dose of 0.6 U/kg LY2963016 during Period 4. There was a minimum washout interval of 6 days between each period.
744383|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744385|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744386|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744387|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744388|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744389|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744390|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744391|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744392|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744393|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744394|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744395|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744396|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744397|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744398|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744399|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744400|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744401|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744402|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744403|NCT01634165|O4|Outcome|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744404|NCT01634165|O3|Outcome|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744405|NCT01634165|O2|Outcome|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744406|NCT01634165|O1|Outcome|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744407|NCT01634165|E4|Reported Event|0.6 U/kg Lantus|Single subcutaneous dose of 0.6 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744408|NCT01634165|E3|Reported Event|0.3 U/kg Lantus|Single subcutaneous dose of 0.3 U/kg Lantus during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744409|NCT01634165|E2|Reported Event|0.6 U/kg LY2963016|Single subcutaneous dose of 0.6 U/kg LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744410|NCT01634165|E1|Reported Event|0.3 U/kg LY2963016|Single subcutaneous dose of 0.3 units/kilogram (U/kg) LY2963016 during 1 of the 4 study periods in 1 of the 4 study sequences. There was a minimum washout interval of 6 days between each period.
744411|NCT01634152|B4|Baseline|Total|Total of all reporting groups
744412|NCT01634152|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744413|NCT01634152|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744414|NCT01634152|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744415|NCT01634152|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744416|NCT01634152|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744417|NCT01634152|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744418|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744419|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744420|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744421|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744422|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744423|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744424|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744425|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744426|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744427|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744428|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744429|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744430|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744431|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744432|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744433|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744434|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744435|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744436|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744437|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744438|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744439|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744620|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744440|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744441|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744442|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744443|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744444|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744445|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744446|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744447|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744448|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744449|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744450|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744451|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744452|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744453|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744454|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744455|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744456|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744457|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744458|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744459|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744460|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744461|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744462|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744463|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744464|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744465|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744466|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744467|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744468|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744469|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744470|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744471|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744472|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744473|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744474|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744475|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744476|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744477|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744478|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744479|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744480|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744481|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744482|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744483|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744484|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744520|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744485|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744486|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744487|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744488|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744489|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744490|NCT01634152|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744491|NCT01634152|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744492|NCT01634152|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744493|NCT01634152|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744494|NCT01634152|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744495|NCT01634152|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 12 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744496|NCT01634139|B4|Baseline|Total|Total of all reporting groups
744497|NCT01634139|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744498|NCT01634139|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744499|NCT01634139|B1|Baseline|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744500|NCT01634139|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744501|NCT01634139|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744502|NCT01634139|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744503|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744504|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744505|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744506|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744507|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744508|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744509|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744510|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744511|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744512|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744513|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744514|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744515|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744516|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744517|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744518|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744519|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744521|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744522|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744523|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744524|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744525|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744526|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744527|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744528|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744529|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744530|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744531|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744532|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744533|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744534|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744535|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744536|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744537|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744538|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744539|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744540|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744541|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744542|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744543|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744544|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744545|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744546|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744547|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744548|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744549|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744550|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744551|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744552|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744553|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744554|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744589|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744555|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744556|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744557|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744558|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744559|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744560|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744561|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744562|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744563|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744564|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744565|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744566|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744567|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744568|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744569|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744570|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744571|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744572|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744573|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744574|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744575|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744576|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744577|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744578|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744619|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744579|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744580|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744581|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744582|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744583|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744584|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744585|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744586|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744587|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744588|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744590|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744591|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744592|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744593|NCT01634139|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744594|NCT01634139|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744595|NCT01634139|O1|Outcome|Placebo Respimat|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744596|NCT01634139|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium (Tio R5) solution (2 puffs of 2.5mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744597|NCT01634139|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium (Tio R2.5) solution (2 puffs of 1.25mcg) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744598|NCT01634139|E1|Reported Event|Placebo|Inhalation of placebo solution (2 puffs) once daily for 48 weeks delivered by the Respimat inhaler, as add on therapy on top of usual care.
744599|NCT01634113|B4|Baseline|Total|Total of all reporting groups
744600|NCT01634113|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744601|NCT01634113|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744602|NCT01634113|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744603|NCT01634113|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744604|NCT01634113|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744605|NCT01634113|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744606|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744607|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744608|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744609|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744610|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744611|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744612|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744613|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744614|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744615|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744616|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744617|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744618|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
748368|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
744621|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744622|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744623|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744624|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744625|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744626|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744627|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744628|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744629|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744630|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744631|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744632|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744633|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744634|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744635|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744636|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744637|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744638|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744639|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744640|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744641|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744642|NCT01634113|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744643|NCT01634113|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744644|NCT01634113|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744645|NCT01634113|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler.
744646|NCT01634113|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 12 weeks, delivered by the Respimat Inhaler
744647|NCT01634113|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks, delivered by the Respimat Inhaler
744648|NCT01634100|B1|Baseline|Study Overall|This was a randomised, 3-way crossover trial. 18 patients were randomised to one of six treatment sequences and treated. It was an open label trial in which each treatment period lasted 4 days with a washout period of at least 7 days between each.
744649|NCT01634100|P6|Participant Flow|Empa + Probenecid / Empa + Rifampicin / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
744650|NCT01634100|P5|Participant Flow|Empa + Probenecid / Empa Alone / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
744651|NCT01634100|P4|Participant Flow|Empa + Rifampicin / Empa + Probenecid / Empa Alone|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa Alone (A single dose of 10mg of empagliflozin (empa))"
744652|NCT01634100|P3|Participant Flow|Empa + Rifampicin / Empa Alone / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
744653|NCT01634100|P2|Participant Flow|Empa Alone / Empa + Probenecid / Empa + Rifampicin|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)"
744654|NCT01634100|P1|Participant Flow|Empa Alone / Empa + Rifampicin / Empa + Probenecid|"Patients were administered three treatments in the following order:~Empa Alone (A single dose of 10mg of empagliflozin (empa))~Empa + Rifampicin (A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin)~Empa + Probenecid (A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3)"
744655|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
744656|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
744657|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
744658|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
744659|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
744660|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
744661|NCT01634100|O3|Outcome|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
744662|NCT01634100|O2|Outcome|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
744663|NCT01634100|O1|Outcome|Empa Alone|A single dose of 10mg of empagliflozin (empa).
744664|NCT01634100|E3|Reported Event|Empa + Probenecid|A single dose of 10mg empagliflozin (empa) in the morning of day 1 combined with 500 mg of probenecid given twice daily for four days from day -1 to day 3.
744665|NCT01634100|E2|Reported Event|Empa + Rifampicin|A single dose of 10mg empagliflozin (empa) combined with a single dose of 600 mg rifampicin.
744666|NCT01634100|E1|Reported Event|Empa Alone|A single dose of 10mg of empagliflozin (empa).
744667|NCT01633944|B3|Baseline|Total|Total of all reporting groups
744668|NCT01633944|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744795|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
744669|NCT01633944|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744670|NCT01633944|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744671|NCT01633944|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744672|NCT01633944|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
744673|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744674|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744675|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744676|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744677|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744678|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744679|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744680|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744681|NCT01633944|O1|Outcome|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 75, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration phase
744682|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744683|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744684|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744685|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744686|NCT01633944|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744687|NCT01633944|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744688|NCT01633944|E3|Reported Event|DB Placebo Film|Placebo buccal film, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744689|NCT01633944|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment phase
744690|NCT01633944|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 75, 150, 300, or 450 μg, applied to the buccal mucosa every 12 hours for up to 8 weeks in the open-label titration treatment phase
744691|NCT01633853|B3|Baseline|Total|Total of all reporting groups
744692|NCT01633853|B2|Baseline|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744719|NCT01633827|O2|Outcome|Treatment Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under the conditions of oxygen and a sedative.
744693|NCT01633853|B1|Baseline|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744694|NCT01633853|P2|Participant Flow|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744695|NCT01633853|P1|Participant Flow|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744696|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744697|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744698|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744699|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744700|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744701|NCT01633853|O1|Outcome|Vitamin D2 Treatment|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744702|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744703|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744704|NCT01633853|O2|Outcome|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744705|NCT01633853|O1|Outcome|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744706|NCT01633853|E2|Reported Event|1,25(OH)2 Vitamin D3|"Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.~1,25(OH)2 Vit D3: Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol)."
744707|NCT01633853|E1|Reported Event|Vitamin D2|"Patients will be treated by vitamin D2. Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.~Vitamin D2: Treatment with Vit D2."
744708|NCT01633827|B1|Baseline|Study Group|"This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions.~During the placebo arm, one participant did not have OSA and another exhibited predominantly central sleep apnea; both were excluded from the analysis. Subject demographics for the 20 remaining unselected patients are shown below."
744709|NCT01633827|P2|Participant Flow|Eszopiclone and Oxygen First, Then Placebo and Air|Subjects will receive both eszopiclone and medical grade oxygen (FIO2 0.4) during two overnight sleep studies, after a washout period of 1 week they will receive placebo and air during two overnight sleep studies
744710|NCT01633827|P1|Participant Flow|Placebo and Air First, Then Eszopiclone and Oxygen|Subjects will receive both a sugar pill and room air during two overnight sleep studies first and subsequently eszopiclone 3 mg with oxygen (FiO2 0.4) after a washout period of 1 week.
744711|NCT01633827|O2|Outcome|Treatment Data|This result reports the AHI under the conditions of oxygen and eszopiclone
744712|NCT01633827|O1|Outcome|Placebo Data|This result reports the AHI under the conditions of room air and a placebo tablet.
744713|NCT01633827|O2|Outcome|Treatment Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during eszopiclone and oxygen administration
744714|NCT01633827|O1|Outcome|Placebo Data|These results represent the ventilation through a active airway (when pharyngeal dilator muscles maximally recruited) at atmospheric pressure during the administration of placebo and room air
744715|NCT01633827|O2|Outcome|Treatment Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during eszopiclone and oxygen administration
744716|NCT01633827|O1|Outcome|Placebo Data|These results represent the ventilation through a passive airway (when pharyngeal dilator muscles are not recruited) at atmospheric pressure and eupneic ventilatory drive during the administration of placebo and room air
744717|NCT01633827|O2|Outcome|Treatment Data|These result report the ventilatory control sensitivity (i.e., loop gain) during eszopiclone and oxygen administration
744718|NCT01633827|O1|Outcome|Placebo Data|These results report the ventilatory control sensitivity (i.e., loop gain) during placebo and room air administration
744720|NCT01633827|O1|Outcome|Placebo Data|These result reports the minimum ventilation that can be tolerated before an arousal from sleep under placebo and room air administration
744721|NCT01633827|E1|Reported Event|Study Group|This study was a randomized cross-over design so each particiapnt enrolled underweent both placebo and treatment conditions
744722|NCT01633320|B3|Baseline|Total|Total of all reporting groups
744723|NCT01633320|B2|Baseline|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
744724|NCT01633320|B1|Baseline|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
744725|NCT01633320|P2|Participant Flow|NRS>3 (Moderate to Severe Pain)|Patients with numerical rating scale pain score >3 at arrival in PACU
744726|NCT01633320|P1|Participant Flow|NRS<=3 (no or Mild Pain)|Patients with numerical rating pain scale <=3 at arrival in PACU
744727|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
744728|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
744729|NCT01633320|O2|Outcome|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
744730|NCT01633320|O1|Outcome|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
744731|NCT01633320|E2|Reported Event|NRS>3|Patients with numerical rating scale pain score >3 at arrival in PACU
744732|NCT01633320|E1|Reported Event|NRS<=3|Patients with numerical rating scale <=3 at arrival in PACU
744733|NCT01632995|B1|Baseline|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744794|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744734|NCT01632995|P1|Participant Flow|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744735|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744736|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744737|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744738|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744739|NCT01632995|O1|Outcome|Participants With DBS Testing|All study participants who had at least 1 DBS result
744740|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744741|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744742|NCT01632995|O1|Outcome|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744743|NCT01632995|O1|Outcome|Participants Assessed for Participation|All participants who were assessed for study participation
744744|NCT01632995|O1|Outcome|Participants Assessed for Participation|All participants who were assessed for study participation
744745|NCT01632995|E1|Reported Event|Emtricitabine (FTC)/Tenofovir Disoproxil Fumarate (TDF)|"All study participants will be assigned to this arm and will receive one FTC/TDF tablet orally once a day.~FTC 200 mg/TDF 300 mg fixed-dose combination tablet: Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food."
744746|NCT01632904|B3|Baseline|Total|Total of all reporting groups
744747|NCT01632904|B2|Baseline|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
744748|NCT01632904|B1|Baseline|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
744749|NCT01632904|P2|Participant Flow|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
744851|NCT01632020|B2|Baseline|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
744750|NCT01632904|P1|Participant Flow|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
744751|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
744752|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
744781|NCT01632735|E1|Reported Event|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
744782|NCT01632709|B5|Baseline|Total|Total of all reporting groups
744753|NCT01632904|O2|Outcome|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
744754|NCT01632904|O1|Outcome|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
744755|NCT01632904|E2|Reported Event|Hydroxyurea|"Hydroxyurea (HU) Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.~Ruxolitinib-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
744756|NCT01632904|E1|Reported Event|Ruxolitinib|"Ruxolitinib Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.~HU-placebo All placebo will be self-administered, and dosing will be the same as with the blinded dose.~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
744757|NCT01632878|B3|Baseline|Total|Total of all reporting groups
744758|NCT01632878|B2|Baseline|Post Myocardial Infarction Non-Omacor Group|Index post Myocardial Infarction patients screened and not treated with Omacor as decided by physician
744759|NCT01632878|B1|Baseline|Post Myocardial Infarction Omacor Group|Index post Myocardial Infarction patients screened and treated with Omacor as decided by physician
744760|NCT01632878|P1|Participant Flow|Post Myocardial Infarction|One single cohort of Index post Myocardial Infarction patients
744761|NCT01632878|O1|Outcome|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
744762|NCT01632878|E1|Reported Event|Post Myocardial Infarction|Index post Myocardial Infarction patients (Omacor group)
744763|NCT01632800|B1|Baseline|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
744764|NCT01632800|P1|Participant Flow|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
744765|NCT01632800|O1|Outcome|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
744766|NCT01632800|E1|Reported Event|Single Arm Study|"Each subjects will undergo escalating exposure to magnetic field~High pulsed magnetic fields: Magnetic fields will escalate in strength"
744767|NCT01632735|B3|Baseline|Total|Total of all reporting groups
744768|NCT01632735|B2|Baseline|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
744769|NCT01632735|B1|Baseline|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
744770|NCT01632735|P2|Participant Flow|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
744771|NCT01632735|P1|Participant Flow|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
744772|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
744773|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
744774|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
744826|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744902|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744775|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
744776|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
744777|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
744778|NCT01632735|O2|Outcome|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
744779|NCT01632735|O1|Outcome|Mobile Continuing Care|"Behavioral: 12-week Structured Texting intervention focused on recovery monitoring, feedback for self-management, social support and education~Mobile Continuing Care: Behavioral: Mobile Texting 12-week intervention. Delivers daily recovering monitoring, self-management feedback, and education/social support"
744780|NCT01632735|E2|Reported Event|Standard Continuing Care as Usual|Continuing care as usual (12-step facilitation) group
744783|NCT01632709|B4|Baseline|Dry Needling at the Neuroma|
744796|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744797|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
744798|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744799|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
744800|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744801|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
744802|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744803|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
744804|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744805|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
744806|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744807|NCT01632709|O4|Outcome|Dry Needling at the Neuroma|Placebo: Dry needling
744808|NCT01632709|O3|Outcome|Neuroma Injection of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744809|NCT01632709|O2|Outcome|Dry Needling|Placebo: Dry needling
744810|NCT01632709|O1|Outcome|Sympathetic Nerve Block of Bupivacaine|Bupivacaine: one injection of 10ml of .25%
744811|NCT01632709|E2|Reported Event|Treatment Group|
744812|NCT01632709|E1|Reported Event|Placebo/Sham Injection|
744813|NCT01632683|B3|Baseline|Total|Total of all reporting groups
744814|NCT01632683|B2|Baseline|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
744815|NCT01632683|B1|Baseline|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
744816|NCT01632683|P2|Participant Flow|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
744817|NCT01632683|P1|Participant Flow|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
744818|NCT01632683|O2|Outcome|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
744819|NCT01632683|O1|Outcome|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
744820|NCT01632683|E2|Reported Event|Glidescope|"Providers will utilize the Glidescope video laryngoscope equipped with the #4 blade to facilitate intubation~Glidescope: Glidescope arm"
744821|NCT01632683|E1|Reported Event|C-MAC|"Providers will utilize the C-MAC video laryngoscope equipped with a D-blade to facilitate intubation~C-MAC: C-MAC arm"
744822|NCT01632423|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744823|NCT01632423|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744824|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744825|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744850|NCT01632020|B3|Baseline|Total|Total of all reporting groups
744827|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744828|NCT01632423|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744829|NCT01632423|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
744830|NCT01632267|B1|Baseline|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
744831|NCT01632267|P1|Participant Flow|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
744832|NCT01632267|O1|Outcome|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
744833|NCT01632267|E1|Reported Event|Depression and Anxiety|Subjects with a primary diagnosis of depression or anxiety disorder.
744834|NCT01632215|B3|Baseline|Total|Total of all reporting groups
744835|NCT01632215|B2|Baseline|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
744836|NCT01632215|B1|Baseline|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
744837|NCT01632215|P2|Participant Flow|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
744838|NCT01632215|P1|Participant Flow|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
744839|NCT01632215|O2|Outcome|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
744840|NCT01632215|O1|Outcome|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
744841|NCT01632215|E2|Reported Event|Sugar Pill|"Placebo group~Sugar pill: Sugar pill 01 dose"
744842|NCT01632215|E1|Reported Event|Preoperative Gabapentine,|"Gabapentine~Gabapentine: Gabapentine 600 mg 01 dose"
744843|NCT01632150|B1|Baseline|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
745079|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
744844|NCT01632150|P1|Participant Flow|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
744845|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
744846|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion.
744847|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks, then beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles, then beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
744848|NCT01632150|O1|Outcome|Thalidomide + Elotuzumab + Dexamethasone + Cyclophosphamide|Participants received thalidomide in 28-day cycles: 50 mg, for the first 2 weeks, escalated to 100 mg for the next 2 weeks and beginning with Cycle 2, to 200 mg once daily. Elotuzumab, 10 mg/kg, was administered as an intravenous infusion weekly for the first 2 cycles and beginning with Cycle 3, every 2 weeks. Dexamethasone, 40 mg, was administered weekly on those weeks when elotuzumab was not administered. On weeks when elotuzumab was also given, participants received dexamethasone as a split dose of 28 mg, 3 to 24 hours before the elotuzumab infusion, and 8 mg intravenously at least 45 minutes before the infusion. Those patients with suboptimal response, defined as evidence of progressive disease between end of Cycle 2 and end of Cycle 4 or inability to achieve partial response or better by end of Cycle 4, also received cyclophosphamide, 50 mg. Cyclophosphamide could not be added beyond Cycle 5.
744849|NCT01632150|E1|Reported Event|All Treated Subjects|
744852|NCT01632020|B1|Baseline|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
744853|NCT01632020|P2|Participant Flow|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
744854|NCT01632020|P1|Participant Flow|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
744855|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
744856|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
744857|NCT01632020|O2|Outcome|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
744858|NCT01632020|O1|Outcome|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
744859|NCT01632020|E2|Reported Event|Metformin|Metformin: 850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
744860|NCT01632020|E1|Reported Event|Placebo|Placebo: 2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
744861|NCT01631929|B3|Baseline|Total|Total of all reporting groups
744862|NCT01631929|B2|Baseline|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
744863|NCT01631929|B1|Baseline|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
744864|NCT01631929|P2|Participant Flow|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
744865|NCT01631929|P1|Participant Flow|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
744866|NCT01631929|O2|Outcome|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
744867|NCT01631929|O1|Outcome|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
744868|NCT01631929|E2|Reported Event|Two Bags|"Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.~Two bags: Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line."
744869|NCT01631929|E1|Reported Event|One Bag|"IV infusion of fluids, electrolytes and dextrose using one bag~One bag: Infusion of dextrose and electrolytes using one bag"
744870|NCT01631864|B3|Baseline|Total|Total of all reporting groups
744871|NCT01631864|B2|Baseline|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
744872|NCT01631864|B1|Baseline|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
744873|NCT01631864|P2|Participant Flow|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
744874|NCT01631864|P1|Participant Flow|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
744875|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
744876|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
744877|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
744878|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
744879|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
744880|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
744881|NCT01631864|O2|Outcome|Amlodipine|amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
744882|NCT01631864|O1|Outcome|LCZ696|LCZ696 400 mg plus placebo to amlodipine once daily for 8 weeks
744883|NCT01631864|E2|Reported Event|Amlodipine|Amlodipine 10 mg plus placebo to LCZ696 once daily for 8 weeks
744884|NCT01631864|E1|Reported Event|LCZ696|LCZ696 400 mg plus placebo to Amlodipine once daily for 8 weeks
744885|NCT01631825|B1|Baseline|SPM 962|SPM 962 transdermal patch
744886|NCT01631825|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
744887|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744888|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744889|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744890|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744891|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744892|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744893|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744894|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744895|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744896|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744897|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744898|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744899|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744900|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744901|NCT01631825|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744906|NCT01631812|P1|Participant Flow|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
744907|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744908|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744909|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744910|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744911|NCT01631812|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
744912|NCT01631812|E1|Reported Event|SPM 962|SPM 962 : SPM 962 transdermal patch once a daily up to 36.0 mg/day
744913|NCT01631682|B5|Baseline|Total|Total of all reporting groups
744914|NCT01631682|B4|Baseline|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
744915|NCT01631682|B3|Baseline|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
744916|NCT01631682|B2|Baseline|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10 minute break and subsequently extinction~Reactivation: subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
744917|NCT01631682|B1|Baseline|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
744918|NCT01631682|P4|Participant Flow|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
744919|NCT01631682|P3|Participant Flow|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
744920|NCT01631682|P2|Participant Flow|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
744921|NCT01631682|P1|Participant Flow|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
745080|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
744922|NCT01631682|O4|Outcome|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
744923|NCT01631682|O3|Outcome|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
744924|NCT01631682|O2|Outcome|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
744925|NCT01631682|O1|Outcome|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
744926|NCT01631682|E4|Reported Event|Intranasal Oxytocin|"A single 32IU dose of Syntocinon (intranasal oxytocin) is given to begin visit 2, followed by a 10 minute wait and subsequent CS reactivation.~Intranasal oxytocin: 32 IU, 8 self-administered intranasal sprays, 4 in each nostril"
744927|NCT01631682|E3|Reported Event|Mifepristone|"a single dose of 1800mg (200mg tablets) mifepristone may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Mifepristone: 1800mg, 9 tablets"
744928|NCT01631682|E2|Reported Event|Reactivation With Time Delay|"For those not receiving propranolol on visit 2, one experimental CS will be reactivated, followed by a 10-min break and then extinction.~Subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)"
744929|NCT01631682|E1|Reported Event|Propranolol|"a single dose of 40mg propranolol may be given to begin visit 2, followed by 90min wait and subsequently CS reactivation~Propranolol: 40mg single pill"
744930|NCT01631630|B3|Baseline|Total|Total of all reporting groups
744931|NCT01631630|B2|Baseline|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744932|NCT01631630|B1|Baseline|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744933|NCT01631630|P2|Participant Flow|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744934|NCT01631630|P1|Participant Flow|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744935|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744936|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744937|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744938|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744939|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744940|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744941|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744942|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744943|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
751692|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
744944|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744945|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744946|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744947|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744948|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744949|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744950|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744951|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744952|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744953|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744954|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744955|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744956|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744957|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744958|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744959|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744960|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745081|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
744961|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744962|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744963|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744964|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744965|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744966|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744967|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744968|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744969|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744970|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744971|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744972|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744973|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744974|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744975|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744976|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744977|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744978|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744979|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744980|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744981|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744982|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744983|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744984|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744985|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744986|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744987|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744988|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744989|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744990|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744991|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744992|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744993|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744994|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744995|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744996|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744997|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
744998|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
744999|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745000|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745001|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745002|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745003|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745004|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745005|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745006|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745007|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745008|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745009|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745010|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745011|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745012|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745013|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745014|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745015|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745016|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745017|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745018|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745019|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745020|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745021|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745022|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745023|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745024|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745025|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745026|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745027|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745028|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745029|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745030|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745031|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745032|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745033|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745034|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745035|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745036|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745037|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745038|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745039|NCT01631630|O2|Outcome|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745040|NCT01631630|O1|Outcome|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745041|NCT01631630|E2|Reported Event|Placebo|Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
745042|NCT01631630|E1|Reported Event|Pioglitazone|Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days
745043|NCT01631435|B1|Baseline|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
745082|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
745083|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
745084|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
745085|NCT01631110|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
745086|NCT01631110|O1|Outcome|Elderly Subjects Aged Over 60 Years|
745044|NCT01631435|P1|Participant Flow|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
745045|NCT01631435|O2|Outcome|# Casesclassified as “Active CD is Likely” by IC|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the Ileo colonoscopy (IC) procedure.~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
745046|NCT01631435|O1|Outcome|# Casesclassified as “Active CD is Likely” by CE|"The number of subjects having active Crohn's disease(CD) in their TI and / or colon as detected by the PillCam Platform with the CD capsule endoscopy(CE).~“Active Crohn’s disease” included the followings lesions:~Aphthous ulceration~Ulcers (other than Aphthous)~Bleeding~Inflammatory stricture Lesions other than the above list were classified as “Non active Crohn’s disease.”"
745047|NCT01631435|E1|Reported Event|Bowel Prep Regimen|"Each study subject will undergo a bowel preparation followed by a PillCam procedure.~Pillcam colon capsule and PillCam™ Prep Procedure: PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.~Ileocolonoscopy: Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure~• Ileocolonoscopy with intubation of terminal ileum"
745048|NCT01631227|B3|Baseline|Total|Total of all reporting groups
745049|NCT01631227|B2|Baseline|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
745050|NCT01631227|B1|Baseline|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
745051|NCT01631227|P2|Participant Flow|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
745052|NCT01631227|P1|Participant Flow|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
745053|NCT01631227|O2|Outcome|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
745054|NCT01631227|O1|Outcome|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
745055|NCT01631227|E2|Reported Event|Eprosartan Mesylate|Eprosartan Mesylate 600 mg + Placebo Eprosartan
745056|NCT01631227|E1|Reported Event|Eprosartan|Eprosartan 450 mg + Placebo Eprosartan Mesylate
745057|NCT01631149|B3|Baseline|Total|Total of all reporting groups
745058|NCT01631149|B2|Baseline|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745059|NCT01631149|B1|Baseline|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745060|NCT01631149|P2|Participant Flow|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745061|NCT01631149|P1|Participant Flow|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745062|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745063|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745064|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745065|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745066|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745067|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745068|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745069|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745070|NCT01631149|O2|Outcome|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745071|NCT01631149|O1|Outcome|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745072|NCT01631149|E2|Reported Event|Deep Surgical Block|Continuous rocuronium infusion will be used to induce a deep surgical block with post tetanic twitch count of max 2. Rocuronium loading dose = 1.0 mg/kg, followed by 0.6-1.0 mg/kg per hour.
745073|NCT01631149|E1|Reported Event|Moderate/Normal Surgical Block|A normal block will be induced by an atracurium bolus dose followed by a mivacurium infusion to induce a train of four count of 1-2.
745074|NCT01631110|B3|Baseline|Total|Total of all reporting groups
745075|NCT01631110|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
745076|NCT01631110|B1|Baseline|Elderly Subjects Aged Over 60 Years|
745077|NCT01631110|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
745078|NCT01631110|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
745087|NCT01631110|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
745088|NCT01631110|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
745089|NCT01631071|B3|Baseline|Total|Total of all reporting groups
745090|NCT01631071|B2|Baseline|Adults From 18 to 60 Years Old Inclusive|
745091|NCT01631071|B1|Baseline|Elderly Subjects Aged Over 60 Years|
745092|NCT01631071|P2|Participant Flow|Adults From 18 to 60 Years Old Inclusive|
745093|NCT01631071|P1|Participant Flow|Elderly Subjects Aged Over 60 Years|
745094|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
745095|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
745096|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
745097|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
745098|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
745099|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
745100|NCT01631071|O2|Outcome|Adults From 18 to 60 Years Old Inclusive|
745101|NCT01631071|O1|Outcome|Elderly Subjects Aged Over 60 Years|
745102|NCT01631071|E2|Reported Event|Adults From 18 to 60 Years Old Inclusive|
745103|NCT01631071|E1|Reported Event|Elderly Subjects Aged Over 60 Years|
745104|NCT01630694|B3|Baseline|Total|Total of all reporting groups
745105|NCT01630694|B2|Baseline|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745106|NCT01630694|B1|Baseline|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745107|NCT01630694|P2|Participant Flow|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745108|NCT01630694|P1|Participant Flow|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745109|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745110|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745111|NCT01630694|O2|Outcome|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745281|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745112|NCT01630694|O1|Outcome|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745113|NCT01630694|E2|Reported Event|Control|"Obese and morbidly obese patients with a large neck circumference. The control group will consist of patients with easy laryngoscopy and intubation, recruited prospectively.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745114|NCT01630694|E1|Reported Event|Difficult Intubation Patients|"Obese and morbidly obese patients with a large neck circumference. This arm was patients who were difficult to intubate during previous anesthetics provided by the staff anesthesiologists.~3D Laser Scanning of the Head, measurements and digital photos of the neck and ultrasound of the tongue were performed."
745115|NCT01630135|B3|Baseline|Total|Total of all reporting groups
745116|NCT01630135|B2|Baseline|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745117|NCT01630135|B1|Baseline|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745118|NCT01630135|P2|Participant Flow|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745119|NCT01630135|P1|Participant Flow|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745120|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745121|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745122|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745123|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745124|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745125|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745126|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745127|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745128|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745129|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745130|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745131|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745132|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745133|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745134|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745135|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745136|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745137|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745138|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745139|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745140|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745141|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745142|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745143|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745144|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745145|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745439|NCT01628926|E2|Reported Event|Ropinirole|Ropinirole tablet
745146|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745147|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745148|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745149|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745150|NCT01630135|O2|Outcome|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745151|NCT01630135|O1|Outcome|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745152|NCT01630135|E2|Reported Event|Placebo|Matching placebo nasal spray was administered as one spray into each nostril once daily in the morning for 2 weeks.
745153|NCT01630135|E1|Reported Event|Fluticasone Furoate 55 µg Per Day|Fluticasone furoate nasal spray (55 micrograms [µg] per day) was administered as one spray into each nostril (27.5 μg per spray) once daily in the morning for 2 weeks.
745154|NCT01630109|B4|Baseline|Total|Total of all reporting groups
745155|NCT01630109|B3|Baseline|Placebo Control|Placebo to be used as the control group
745156|NCT01630109|B2|Baseline|Metoclopramide 10 mg|Pro-motility agent
745157|NCT01630109|B1|Baseline|Metoclopramide 5 mg|Pro-motility agent
745158|NCT01630109|P3|Participant Flow|Placebo Control|Placebo to be used as the control group
745159|NCT01630109|P2|Participant Flow|Metoclopramide 10 mg|Pro-motility agent
745160|NCT01630109|P1|Participant Flow|Metoclopramide 5 mg|Pro-motility agent
745161|NCT01630109|O6|Outcome|Placebo (Non-diabetic)|Placebo control given to non-diabetics
745162|NCT01630109|O5|Outcome|Metoclopramide 10 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
745163|NCT01630109|O4|Outcome|Metoclopramide 5 mg (Non-diabetic)|Pro-motility agent given to non-diabetic patients
745164|NCT01630109|O3|Outcome|Placebo Control (Diabetics)|Placebo to be used as the control group in diabetic patients
745165|NCT01630109|O2|Outcome|Metoclopramide 10 mg (Diabetics)|Pro-motility agent given to diabetic patients
745166|NCT01630109|O1|Outcome|Metoclopramide 5 mg (Diabetics)|Pro-motility agent given to diabetic patients
745167|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
745170|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
745171|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
745172|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
745173|NCT01630109|O3|Outcome|Placebo Control|Placebo to be used as the control group
745174|NCT01630109|O2|Outcome|Metoclopramide 10 mg|Pro-motility agent
745175|NCT01630109|O1|Outcome|Metoclopramide 5 mg|Pro-motility agent
745176|NCT01630109|E3|Reported Event|Placebo Control|Placebo to be used as the control group
745177|NCT01630109|E2|Reported Event|Metoclopramide 10 mg|Pro-motility agent
745178|NCT01630109|E1|Reported Event|Metoclopramide 5 mg|Pro-motility agent
745179|NCT01629823|B4|Baseline|Total|Total of all reporting groups
745180|NCT01629823|B3|Baseline|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745181|NCT01629823|B2|Baseline|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745182|NCT01629823|B1|Baseline|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745183|NCT01629823|P3|Participant Flow|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
745184|NCT01629823|P2|Participant Flow|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
745185|NCT01629823|P1|Participant Flow|CPAP Less Than 1 cm Water (H₂O)|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks.
745186|NCT01629823|O3|Outcome|CPAP 10cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745187|NCT01629823|O2|Outcome|CPAP 5cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745188|NCT01629823|O1|Outcome|CPAP Less Than 1 cm H2O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745189|NCT01629823|E3|Reported Event|CPAP 10cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745190|NCT01629823|E2|Reported Event|CPAP 5cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745191|NCT01629823|E1|Reported Event|CPAP Less Than 1 cm H₂O|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
745192|NCT01629797|B1|Baseline|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
745207|NCT01629771|B2|Baseline|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
745208|NCT01629771|B1|Baseline|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
745402|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745193|NCT01629797|P1|Participant Flow|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
745194|NCT01629797|O2|Outcome|Two Months Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
745195|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
745196|NCT01629797|O2|Outcome|Post-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
745197|NCT01629797|O1|Outcome|Pre-educational Lecture|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture.
745198|NCT01629797|E1|Reported Event|Acne Vulgaris|Subjects completed a questionnaire assessing 26 items related to knowledge of acne pathogenesis, signs and symptoms of acne, risk factors for acne, and beliefs about acne. Next, subjects listened to a scripted, educational lecture about acne developed from the American Academy of Dermatology (AAD) acne educational materials. In addition, the AAD patient education pamphlet on acne was provided to each subject. Subjects completed the questionnaire to assess knowledge about acne immediately post-lecture. Two months after the educational lecture, subjects were contacted by phone to complete a final questionnaire to assess knowledge about acne.
745199|NCT01629784|B1|Baseline|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
745440|NCT01628926|E1|Reported Event|SPM 962|SPM 962 transdermal patch
745200|NCT01629784|P1|Participant Flow|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
745201|NCT01629784|O2|Outcome|Three Months Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
745202|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection. 3 months later, subjects were contacted by phone to complete a knowledge and behavioral assessment about CLE and sun protection.
745203|NCT01629784|O2|Outcome|Post-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
745204|NCT01629784|O1|Outcome|Pre-educational Lecture|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a written questionnaire to assess knowledge about CLE and sun protection.
745205|NCT01629784|E1|Reported Event|Cutaneous Lupus Erythematosus (CLE)|Subjects completed a written questionnaire to collect demographic data, including personal history of CLE and sun protection behaviors, and to assess knowledge about CLE and sun protection. Next, subjects listened to a scripted, educational lecture about CLE and sun protection, and then immediately completed a post-lecture written questionnaire to assess knowledge about CLE and sun protection. Three months after the educational lecture, subjects were contacted by phone to complete a final knowledge and behavioral assessment.
745206|NCT01629771|B3|Baseline|Total|Total of all reporting groups
745209|NCT01629771|P2|Participant Flow|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
745210|NCT01629771|P1|Participant Flow|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
745211|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
745212|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
745213|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
745214|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
745215|NCT01629771|O2|Outcome|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
745216|NCT01629771|O1|Outcome|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
745217|NCT01629771|E2|Reported Event|Control Subjects|Age- and gender-matched control subjects completed health-related quality of life questionnaires.
745218|NCT01629771|E1|Reported Event|Subjects With Lymphatic Filariasis|Subjects with lymphatic filariasis completed health-related quality of life questionnaires.
745219|NCT01629706|B1|Baseline|Overall|All enrolled participants
745220|NCT01629706|P1|Participant Flow|PureVision/Habitual|Phase 1: Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for two hours and four hours at a time, separate days, with Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in the fellow eye. Phase 2: Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care.
745221|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745222|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745223|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745224|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745225|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745226|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745227|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745228|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745229|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745230|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745231|NCT01629706|O2|Outcome|Symptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745232|NCT01629706|O1|Outcome|Asymptomatic|Habitual contact lenses worn bilaterally on a daily wear basis for 4 weeks with habitual lens care
745233|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
745234|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
745235|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
745236|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
745237|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
745238|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
745239|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
745240|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
745241|NCT01629706|O2|Outcome|PV+Renu|Balafilcon A contact lens pre-soaked overnight in renu multi-purpose solution worn in 1 eye for 2 hours and 4 hours, separate days
745242|NCT01629706|O1|Outcome|PV+ClearCare|Balafilcon A contact lens pre-soaked overnight in ClearCare cleaning and disinfecting system worn in 1 eye for 2 hours and 4 hours, separate days
745243|NCT01629706|E2|Reported Event|Habitual|Habitual contact lenses worn in Phase 2
745244|NCT01629706|E1|Reported Event|PureVision|Balafilcon A contact lenses worn in Phase 1
745245|NCT01629693|B3|Baseline|Total|Total of all reporting groups
745246|NCT01629693|B2|Baseline|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745247|NCT01629693|B1|Baseline|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745248|NCT01629693|P2|Participant Flow|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745249|NCT01629693|P1|Participant Flow|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745250|NCT01629693|O2|Outcome|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745251|NCT01629693|O1|Outcome|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745401|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745252|NCT01629693|E2|Reported Event|Biofinity|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745253|NCT01629693|E1|Reported Event|Air Optix|Contact lenses worn bilaterally for at least 4 hours a day, 5 days a week, for 4 weeks, on a daily wear basis
745254|NCT01629667|B4|Baseline|Total|Total of all reporting groups
745255|NCT01629667|B3|Baseline|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745256|NCT01629667|B2|Baseline|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745257|NCT01629667|B1|Baseline|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745258|NCT01629667|P3|Participant Flow|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745259|NCT01629667|P2|Participant Flow|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745260|NCT01629667|P1|Participant Flow|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745261|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745262|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745263|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745264|NCT01629667|O2|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745265|NCT01629667|O1|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745266|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745267|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745268|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745269|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745270|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745271|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745272|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745273|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745274|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745275|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745276|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745277|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745278|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745279|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745280|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745282|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745283|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745284|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745285|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745286|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745287|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745288|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745289|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745290|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745291|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745292|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745293|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745294|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745295|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745296|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745297|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745298|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745299|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745300|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745301|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745302|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745303|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745304|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745305|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745306|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745307|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745308|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745309|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745310|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745311|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745312|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745313|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745314|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745315|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745316|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745317|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745318|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745319|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745320|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745321|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745322|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745323|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745324|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745325|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745326|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745327|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745328|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745329|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745330|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745331|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745332|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745333|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745334|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745335|NCT01629667|O3|Outcome|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745336|NCT01629667|O2|Outcome|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745337|NCT01629667|O1|Outcome|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745338|NCT01629667|E3|Reported Event|Tralokinumab 800 mg|Participants received Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
745339|NCT01629667|E2|Reported Event|Tralokinumab 400 Milligram (mg)|Participants received Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
745340|NCT01629667|E1|Reported Event|Placebo|Participants received placebo intravenous (IV) once every 4 Weeks (Q4W) for 68 Weeks.
745341|NCT01629589|B3|Baseline|Total|Total of all reporting groups
745342|NCT01629589|B2|Baseline|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745343|NCT01629589|B1|Baseline|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745344|NCT01629589|P2|Participant Flow|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745345|NCT01629589|P1|Participant Flow|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745346|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745347|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745348|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745349|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745350|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745351|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745352|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745353|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745354|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745355|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745356|NCT01629589|O2|Outcome|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745357|NCT01629589|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745358|NCT01629589|E2|Reported Event|BOOSTRIX® Vaccine Group|Participants received a single dose of BOOSTRIX® vaccine
745359|NCT01629589|E1|Reported Event|Adacel® Vaccine Group|Participants received a single dose of Adacel® vaccine
745360|NCT01629290|B1|Baseline|Varnish and Placebo|Three dental varnishes with 5% NaF active ingredient and placebo bland varnish containing no NaF
745361|NCT01629290|P1|Participant Flow|Varnishes and Placebo|"Three dental varnishes with 5% NaF active ingredient (Enamel Pro, Duraphat and Vanish) and one bland varnish with no NaF applied to each subject at four timepoints.~Each of the 15 participants received each of the four treatments, but the order followed was randomly arranged to be different, so there were twelve different patterns of assignment. Because all participants completed all four interventions, and the order was different for each, milestones are not used to indicate participation in each treatment, as that might imply a sequence, rather than simply that they received that intervention."
745362|NCT01629290|O4|Outcome|Placebo|Bland varnish containing no NaF
745363|NCT01629290|O3|Outcome|Vanish|Dental varnish with 5% NaF active ingredient
745364|NCT01629290|O2|Outcome|Duraphat|Dental varnish with 5% NaF active ingredient
745365|NCT01629290|O1|Outcome|Enamel Pro|Dental varnish with 5% NaF active ingredient
745366|NCT01629290|E4|Reported Event|Vanish|Dental varnish with 5% NaF active ingredient
745367|NCT01629290|E3|Reported Event|Duraphat|Dental varnish with 5% NaF active ingredient
745368|NCT01629290|E2|Reported Event|Placebo|Placebo bland varnish containing no NaF
745369|NCT01629290|E1|Reported Event|Enamel Pro|Dental varnish with 5% NaF active ingredient
745370|NCT01629134|B1|Baseline|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745371|NCT01629134|P1|Participant Flow|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745372|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745373|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745374|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745375|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745376|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745377|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745441|NCT01628913|B3|Baseline|Total|Total of all reporting groups
745378|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745379|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745380|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745381|NCT01629134|O1|Outcome|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745382|NCT01629134|E1|Reported Event|Volbella|"Subjects treated with JUVÉDERM VOLBELLA™ according to the physician's experience and Directions for Use~Crosslinked hyaluronic acid gel : All treatments are carried out according to the physician's experience and the Directions for Use"
745383|NCT01628965|B1|Baseline|SPM 962|SPM 962 transdermal patch
745384|NCT01628965|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
745385|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745386|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745387|NCT01628965|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745388|NCT01628965|E1|Reported Event|SPM 962|SPM 962 transdermal patch
745389|NCT01628926|B4|Baseline|Total|Total of all reporting groups
745390|NCT01628926|B3|Baseline|Placebo|SPM962 placebo patch and Ropinirole placebo tab
745391|NCT01628926|B2|Baseline|Ropinirole|Ropinirole tablet
745392|NCT01628926|B1|Baseline|SPM 962|SPM 962 transdermal patch
745393|NCT01628926|P3|Participant Flow|Placebo|SPM962 placebo patch and Ropinirole placebo tab
745394|NCT01628926|P2|Participant Flow|Ropinirole|Ropinirole tablet
745395|NCT01628926|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
745396|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745397|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745398|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745399|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
745400|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745479|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745403|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745404|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745405|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745406|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745407|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745408|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745409|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745410|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745411|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745412|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745413|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745414|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab.
745415|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745416|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745417|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745418|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745419|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745420|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745421|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745422|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745423|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745424|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745425|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745426|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745427|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745428|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745429|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745430|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745431|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745432|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745433|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745434|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745435|NCT01628926|O3|Outcome|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
745436|NCT01628926|O2|Outcome|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
745437|NCT01628926|O1|Outcome|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
745438|NCT01628926|E3|Reported Event|Placebo|SPM962 placebo patch and Ropinirole placebo tab
745444|NCT01628913|P2|Participant Flow|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
745445|NCT01628913|P1|Participant Flow|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
745446|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
745447|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
745448|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
745449|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
745450|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
745451|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
745452|NCT01628913|O2|Outcome|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
745453|NCT01628913|O1|Outcome|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
745454|NCT01628913|E2|Reported Event|Everolimus|Patients received Everolimus 10 mg qd p.o. (by mouth, daily)
745455|NCT01628913|E1|Reported Event|BEZ235|Patients received BEZ235 400 mg bid p.o. (by mouth, twice daily)
745456|NCT01628848|B3|Baseline|Total|Total of all reporting groups
745457|NCT01628848|B2|Baseline|Placebo|Placebo transdermal patch
745458|NCT01628848|B1|Baseline|SPM 962|SPM 962 transdermal patch
745459|NCT01628848|P2|Participant Flow|Placebo|Placebo transdermal patch
745460|NCT01628848|P1|Participant Flow|SPM 962|SPM 962 transdermal patch
745461|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745462|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745463|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745464|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745465|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745466|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745467|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745468|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745469|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745470|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745471|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745472|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745473|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745474|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745475|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745476|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745477|NCT01628848|O2|Outcome|Placebo|Placebo transdermal patch
745478|NCT01628848|O1|Outcome|SPM 962|SPM 962 transdermal patch
745488|NCT01628692|B6|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745489|NCT01628692|B5|Baseline|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745490|NCT01628692|B4|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
745491|NCT01628692|B3|Baseline|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745492|NCT01628692|B2|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745493|NCT01628692|B1|Baseline|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745508|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745494|NCT01628692|P6|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745495|NCT01628692|P5|Participant Flow|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745496|NCT01628692|P4|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
745497|NCT01628692|P3|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745498|NCT01628692|P2|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745499|NCT01628692|P1|Participant Flow|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745500|NCT01628692|O3|Outcome|Genotype1a: Daclatasvir +Simeprevir + Ribavirin(Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745501|NCT01628692|O2|Outcome|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
754250|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
745502|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745503|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745504|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745505|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
745506|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745507|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745601|NCT01628042|P3|Participant Flow|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745602|NCT01628042|P2|Participant Flow|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745509|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745510|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745511|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
745512|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745513|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745514|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745515|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745516|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745549|NCT01628601|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
745517|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
745518|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745519|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745520|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745521|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745522|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745523|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745603|NCT01628042|P1|Participant Flow|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
748369|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
745524|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745525|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up
745526|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745527|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745528|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745529|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745530|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745531|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745649|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745532|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745533|NCT01628692|O6|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1a, who never attained ≥2 log10 decline in hepatitis C virus genotype RNA level after 12 weeks of prior therapy. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks
745534|NCT01628692|O5|Outcome|Genotype 1a: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1a. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745535|NCT01628692|O4|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Null)|Participants with hepatitis C virus genotype 1b, who never attained ≥2 log10 decline in hepatitis C virus RNA level after 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID were continued to receive treatment for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up period.
745536|NCT01628692|O3|Outcome|Genotype 1b: Daclatasvir + Simeprevir + Ribavirin (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745537|NCT01628692|O2|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Null)|Participants with hepatitis C virus genotype 1b, and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal QD, for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745538|NCT01628692|O1|Outcome|Genotype 1b: Daclatasvir + Simeprevir (Naive)|Participants with no prior treatment of hepatitis C virus genotype 1b. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745594|NCT01628250|E1|Reported Event|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
745539|NCT01628692|E3|Reported Event|Genotype1a: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1a and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>=75 kg, respectively) ribavirin BID for a period of 24 weeks and continued into post-treatment follow-up period of 24 weeks.
745540|NCT01628692|E2|Reported Event|Genotype1b: Daclatasvir +Simeprevir + Ribavirin (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food, simeprevir 150 mg with a light to standard meal QD, and weight stratified (1000/1200 mg for participants weighing <75/>= 75 kg, respectively) ribavirin twice daily (BID) for a period of 12 or 24 weeks based on re-randomization and continued into post-treatment follow-up.
745541|NCT01628692|E1|Reported Event|Genotype 1b: Daclatasvir + Simeprevir (Naive + Null)|Participants with and without prior treatment of hepatitis C virus genotype 1b and who never attained ≥2 log10 decline in hepatitis C virus RNA levels after at least 12 weeks of prior therapy with peginterferon/ribavirin. Received daclatasvir 30 mg with or without food and simeprevir 150 mg with a light to standard meal once daily (QD), for a period of 12 weeks or 24 weeks based on re-randomization and continued into a post-treatment follow-up period.
745542|NCT01628614|B1|Baseline|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
745543|NCT01628614|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
745544|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
745545|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
745546|NCT01628614|O1|Outcome|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
745547|NCT01628614|E1|Reported Event|POAG or OHT|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
745548|NCT01628601|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
754251|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
745550|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
745551|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
745552|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
745553|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
745554|NCT01628601|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
745555|NCT01628601|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
745556|NCT01628588|B1|Baseline|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745557|NCT01628588|P1|Participant Flow|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745558|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745559|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745560|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745561|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745562|NCT01628588|O1|Outcome|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745563|NCT01628588|E1|Reported Event|POAG or OHT|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
745564|NCT01628510|B3|Baseline|Total|Total of all reporting groups
745595|NCT01628042|B5|Baseline|Total|Total of all reporting groups
745596|NCT01628042|B4|Baseline|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
745597|NCT01628042|B3|Baseline|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745598|NCT01628042|B2|Baseline|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745565|NCT01628510|B2|Baseline|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
745566|NCT01628510|B1|Baseline|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
745567|NCT01628510|P2|Participant Flow|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
745568|NCT01628510|P1|Participant Flow|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
745569|NCT01628510|O2|Outcome|Dandle Roo/Dandle Wrap|"The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.~Dandle Roo/Dandle Wrap: Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when teh infant is lying in the isolette or crib, but is taken out for hands on care times or when held."
745570|NCT01628510|O1|Outcome|Traditional NICU Positioning|"Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.~Traditional Positioning: Traditional positioning methods are used with the infant throughout the NICU hospitalization."
745571|NCT01628510|E2|Reported Event|Traditional NICU Positioning|Methods of positioning in the NICU have been used for several decades. These methods aim at providing containment and flexion and may consist of swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper® The continued use of these methods of positioning is the control group in the current study.
745650|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745940|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in the base study and the current study.
745572|NCT01628510|E1|Reported Event|Dandle Roo/Dandle Wrap|The new Dandle Roo and Dandle Wrap were developed by NICU professionals to support the neurodevelopment of the preterm infant, and this device is produced by Dandle Lion Medical. The Dandle Roo/Wrap provides all around contact, containment, and proprioceptive input, (which more closely mimics the uterine environment) and can decrease excitability and promote self-regulation, while also allowing for movement with recoil back to flexion.
745573|NCT01628367|B3|Baseline|Total|Total of all reporting groups
745574|NCT01628367|B2|Baseline|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
745575|NCT01628367|B1|Baseline|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
745576|NCT01628367|P2|Participant Flow|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
745577|NCT01628367|P1|Participant Flow|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
745578|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
745599|NCT01628042|B1|Baseline|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745600|NCT01628042|P4|Participant Flow|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
745579|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
745580|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
745581|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
745582|NCT01628367|O2|Outcome|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
745583|NCT01628367|O1|Outcome|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
745622|NCT01627860|B1|Baseline|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745584|NCT01628367|E2|Reported Event|Control|"Collagen plug:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the control group will receive a collagen wound dressing over the socket.~Collagen plug placement: A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket"
745585|NCT01628367|E1|Reported Event|Test|"Membrane:~Extraction and immediate implant placement will be performed. The gaps between the implant and socket walls will be filled with a bone graft material. Sites in the test group will receive a high-density PTFE (d-PTFE) membrane over the socket.~Membrane placement: A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area."
745586|NCT01628250|B3|Baseline|Total|Total of all reporting groups
745587|NCT01628250|B2|Baseline|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
745588|NCT01628250|B1|Baseline|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
745589|NCT01628250|P2|Participant Flow|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
745590|NCT01628250|P1|Participant Flow|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
745591|NCT01628250|O2|Outcome|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
745592|NCT01628250|O1|Outcome|Laparoscopic Complete Mesocolic Excision|"Randomized group of patients receiving laparoscopic colectomy with the concept of complete mesocolic excision~laparoscopic complete mesocolic excision: laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized."
745593|NCT01628250|E2|Reported Event|D3 Laparoscopic Colectomy|"Randomized group of patients receiving laparoscopic colectomy with D3-resection~D3-laparoscopic colectomy: D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications."
745604|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
745605|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745606|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745607|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745608|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
745609|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745610|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745611|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745612|NCT01628042|O4|Outcome|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
745613|NCT01628042|O3|Outcome|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745614|NCT01628042|O2|Outcome|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745615|NCT01628042|O1|Outcome|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745616|NCT01628042|E4|Reported Event|Healthy Matched Control Participants|Participants received a single oral dose of vibegron 100 mg on Day 1.
745617|NCT01628042|E3|Reported Event|Participants With Mild Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745618|NCT01628042|E2|Reported Event|Participants With Moderate Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745619|NCT01628042|E1|Reported Event|Participants With Severe Renal Insufficiency|Participants received a single oral dose of vibegron 100 mg on Day 1.
745620|NCT01627860|B3|Baseline|Total|Total of all reporting groups
745621|NCT01627860|B2|Baseline|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745648|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
754252|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
745623|NCT01627860|P2|Participant Flow|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745624|NCT01627860|P1|Participant Flow|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745625|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745626|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745627|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745628|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745629|NCT01627860|O2|Outcome|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745630|NCT01627860|O1|Outcome|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745674|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745675|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745676|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745631|NCT01627860|E2|Reported Event|Topiramate add-on Therapy|Participants received topiramate in addition to previous ant-epileptic drug. Participants received a starting dose of 25 mg/day in the morning during week 1 and the dosage was increased to 50 mg/day in 2 doses (morning and evening) during week 2. Consequently, the dosage was increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage was increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745632|NCT01627860|E1|Reported Event|Topiramate Monotherapy|Participants received a starting dose of 25 mg/day during week 1 and the dosage increased to 50 mg/day in 2 doses during week 2. Consequently, the dosage increased to 75 mg/day and 100 mg/day in 2 doses during week 3 and week 4, respectively. The dosage increased to 150 mg/day in 2 doses at week 5~6 and 200 mg/day in 2 doses at week 7~8.
745633|NCT01627782|B5|Baseline|Total|Total of all reporting groups
745634|NCT01627782|B4|Baseline|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745635|NCT01627782|B3|Baseline|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745636|NCT01627782|B2|Baseline|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745637|NCT01627782|B1|Baseline|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745638|NCT01627782|P4|Participant Flow|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745639|NCT01627782|P3|Participant Flow|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745640|NCT01627782|P2|Participant Flow|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745641|NCT01627782|P1|Participant Flow|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745642|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745643|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745644|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745645|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745646|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745647|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745651|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745652|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745653|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745654|NCT01627782|O2|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745655|NCT01627782|O1|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745656|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745657|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745658|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745659|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745660|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745661|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745662|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745663|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745664|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745665|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745666|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745667|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745668|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745669|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745670|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745671|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745672|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745673|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745677|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745678|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745679|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745680|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745681|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745682|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745683|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745684|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745685|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745686|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745687|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745688|NCT01627782|O4|Outcome|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745689|NCT01627782|O3|Outcome|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745690|NCT01627782|O2|Outcome|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745691|NCT01627782|O1|Outcome|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745692|NCT01627782|E4|Reported Event|Ketamine: 3 Times Per Week|Participants received 0.50 mg/kg ketamine IV infusion 3 times weekly for 4 weeks.
745693|NCT01627782|E3|Reported Event|Placebo: 3 Times Per Week|Participants received IV infusion of placebo 3 times weekly for 4 weeks.
745694|NCT01627782|E2|Reported Event|Ketamine: 2 Times Per Week|Participants received 0.50 milligram per kilogram (mg/kg) ketamine IV infusion 2 times weekly for 4 weeks.
745695|NCT01627782|E1|Reported Event|Placebo: 2 Times Per Week|Participants received Intravenous (IV) infusion of placebo 2 times weekly for 4 weeks.
745696|NCT01627561|B3|Baseline|Total|Total of all reporting groups
745697|NCT01627561|B2|Baseline|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745698|NCT01627561|B1|Baseline|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745699|NCT01627561|P2|Participant Flow|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745700|NCT01627561|P1|Participant Flow|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745701|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745702|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745703|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745704|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745705|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745706|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745707|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745708|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745709|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745710|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745711|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745712|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745713|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745714|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745715|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745716|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745717|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745718|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745719|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745720|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745721|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745722|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745970|NCT01626118|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745723|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745724|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745725|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745726|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745727|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745728|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745729|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745730|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745731|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745732|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745733|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745734|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745735|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745736|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745737|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745738|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745739|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745740|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745741|NCT01627561|O2|Outcome|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745742|NCT01627561|O1|Outcome|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745743|NCT01627561|E2|Reported Event|Priorix + Infanrix Group|Subjects aged 4-6 years receiving 1 dose of Priorix vaccine at Day 0 and 1 dose of Infanrix vaccine at Month 6
745744|NCT01627561|E1|Reported Event|Cervarix Group|Subjects aged 4-6 years receiving 2 doses of Cervarix vaccine at Day 0 and Month 6
745745|NCT01627340|B3|Baseline|Total|Total of all reporting groups
745936|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
745746|NCT01627340|B2|Baseline|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745747|NCT01627340|B1|Baseline|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745748|NCT01627340|P2|Participant Flow|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745749|NCT01627340|P1|Participant Flow|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745750|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of EngerixTM-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745751|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of EngerixTM-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745752|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745753|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745754|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745755|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745756|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745757|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745792|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745758|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745759|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745760|NCT01627340|O2|Outcome|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745761|NCT01627340|O1|Outcome|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745762|NCT01627340|E2|Reported Event|Control Group|Subjects with no diagnosis or documented history of diabetes who received 3 doses of Engerix™-B (HBV) vaccine at 0, 1 and 6 months. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
745763|NCT01627340|E1|Reported Event|Diabetes Group|Subjects diagnosed with type 2 diabetes within the five year period before study start who received 3 doses of Engerix™-B vaccine (HBV) at 0, 1 and 6 months. The vaccine was administered intramuscularly (IM) into the deltoid region of the non-dominant arm.
745764|NCT01627327|B3|Baseline|Total|Total of all reporting groups
745765|NCT01627327|B2|Baseline|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
745766|NCT01627327|B1|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
745767|NCT01627327|P2|Participant Flow|TIO 18 µg OD|Participants received tiotropium bromide (TIO) 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
745768|NCT01627327|P1|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) inhalation once daily (OD) via a dry powder inhaler (DPI) and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
745769|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
745770|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
745771|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
745772|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
745937|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
745773|NCT01627327|O2|Outcome|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
745774|NCT01627327|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
745775|NCT01627327|E2|Reported Event|TIO 18 µg OD|Participants received TIO 18 µg inhalation OD via a HandiHaler and placebo inhalation OD via a DPI in the morning for 12 weeks.
745776|NCT01627327|E1|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation OD via a DPI and placebo inhalation OD via a HandiHaler in the morning for 12 weeks.
745777|NCT01627249|B4|Baseline|Total|Total of all reporting groups
745778|NCT01627249|B3|Baseline|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745779|NCT01627249|B2|Baseline|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745780|NCT01627249|B1|Baseline|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745781|NCT01627249|P3|Participant Flow|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745782|NCT01627249|P2|Participant Flow|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745783|NCT01627249|P1|Participant Flow|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745784|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745785|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745786|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745787|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745788|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745789|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745790|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745791|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745847|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
745793|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745794|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745795|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745796|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745797|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745798|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745799|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745800|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745801|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745802|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745803|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745804|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745805|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745806|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745807|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745808|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745938|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
745809|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745810|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745811|NCT01627249|O3|Outcome|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
745812|NCT01627249|O2|Outcome|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745813|NCT01627249|O1|Outcome|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745814|NCT01627249|E3|Reported Event|Ranibizumab|0.3 mg intravitreal ranibizumab: Intravitreal injection of 0.3 mg ranibizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745815|NCT01627249|E2|Reported Event|Bevacizumab|1.25 mg intravitreal bevacizumab: Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
745816|NCT01627249|E1|Reported Event|Aflibercept|2.0 mg intravitreal aflibercept: Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
745817|NCT01627002|B3|Baseline|Total|Total of all reporting groups
745818|NCT01627002|B2|Baseline|Part B|
745819|NCT01627002|B1|Baseline|Part A|
745820|NCT01627002|P9|Participant Flow|Part B Placebo|Placebo was administered 30 minutes after lipopolysaccharide challenge
745821|NCT01627002|P8|Participant Flow|Part B PA401 3.0 mg|PA401 3.0 mg was administered 30 minutes after lipopolysaccharide challenge
745822|NCT01627002|P7|Participant Flow|Part B PA401 1.0 mg|PA401 1.0 mg was administered 30 minutes after lipopolysaccharide challenge
745823|NCT01627002|P6|Participant Flow|Part A Placebo|
745824|NCT01627002|P5|Participant Flow|Part A PA401 10 mg|
745825|NCT01627002|P4|Participant Flow|Part A PA401 3.0 mg|
745826|NCT01627002|P3|Participant Flow|Part A PA401 1.0 mg|
745827|NCT01627002|P2|Participant Flow|Part A PA401 0.3 mg|
745828|NCT01627002|P1|Participant Flow|Part A PA401 0.1 mg|
745829|NCT01627002|O3|Outcome|Part B Placebo|
745830|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
745831|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
745832|NCT01627002|O3|Outcome|Part B Placebo|
745833|NCT01627002|O2|Outcome|Part B 1.0 mg PA401|
745834|NCT01627002|O1|Outcome|Part B 3.0 mg PA401|
745835|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
745836|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
745837|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
745838|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
745839|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
745840|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
745841|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
745842|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
745843|NCT01627002|O4|Outcome|Part B PA401 3.0 mg|
745844|NCT01627002|O3|Outcome|Part B PA401 1.0 mg|
745845|NCT01627002|O2|Outcome|Part A PA401 3.0 mg|
745846|NCT01627002|O1|Outcome|Part A PA401 1.0 mg|
745879|NCT01626820|B2|Baseline|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745880|NCT01626820|B1|Baseline|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745881|NCT01626820|P2|Participant Flow|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm at Day 0
745882|NCT01626820|P1|Participant Flow|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745883|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745884|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745885|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745886|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745887|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745888|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745889|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745890|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745891|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745892|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745893|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745939|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study.
745894|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745895|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745896|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745897|NCT01626820|O2|Outcome|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745898|NCT01626820|O1|Outcome|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745899|NCT01626820|E2|Reported Event|Fluviral Elderly Group|Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
745900|NCT01626820|E1|Reported Event|Fluviral Adults Group|Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
745901|NCT01626690|B3|Baseline|Total|Total of all reporting groups
745902|NCT01626690|B2|Baseline|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745903|NCT01626690|B1|Baseline|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745904|NCT01626690|P2|Participant Flow|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745905|NCT01626690|P1|Participant Flow|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745906|NCT01626690|O2|Outcome|SpotOn (3M) Temperature Readings.|Patient temperature at time of incision as measured by SpotOn (3M) temperature monitoring system.
745907|NCT01626690|O1|Outcome|Temporal Artery Thermometer|Patient temperature at time of incision as measured by temporal artery thermometer.
745908|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745909|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745910|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745911|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745912|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745913|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745914|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745915|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745916|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745917|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745918|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745919|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745920|NCT01626690|O2|Outcome|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745921|NCT01626690|O1|Outcome|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745922|NCT01626690|E2|Reported Event|Control|Bair-Hugger Warming Device: Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
745923|NCT01626690|E1|Reported Event|Pre-Warming|Bair-Paws Warming Device: Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
745924|NCT01626456|B3|Baseline|Total|Total of all reporting groups
745925|NCT01626456|B2|Baseline|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
745926|NCT01626456|B1|Baseline|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
745927|NCT01626456|P2|Participant Flow|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
745928|NCT01626456|P1|Participant Flow|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
745929|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
745930|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
745931|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
745932|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
745933|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
745934|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
745935|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
745941|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
745942|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in the base study and in the current study.
745943|NCT01626456|O1|Outcome|PBO-440 mg|Subjects who received placebo in the base study and low dose in the current study
745944|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
745945|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
745946|NCT01626456|O5|Outcome|De Novo|Subjects who did not participate in the base study. These subjects received high dose.
745947|NCT01626456|O4|Outcome|882-882 mg|Subjects who received high dose in both the base study and the current study.
745948|NCT01626456|O3|Outcome|PBO-882 mg|Subjects who received placebo in the base study and high dose in the current study.
745949|NCT01626456|O2|Outcome|441-441 mg|Subjects who received low dose in both the base study and the current study.
745950|NCT01626456|O1|Outcome|PBO-441 mg|Subjects who received placebo in the base study and low dose in the current study.
745951|NCT01626456|O2|Outcome|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
745952|NCT01626456|O1|Outcome|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
745953|NCT01626456|E2|Reported Event|ALKS 9072, High|ALKS 9072, High: IM injection, given monthly
745954|NCT01626456|E1|Reported Event|ALKS 9072, Low|ALKS 9072, Low: IM injection, given monthly
745955|NCT01626391|B3|Baseline|Total|Total of all reporting groups
745956|NCT01626391|B2|Baseline|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
745957|NCT01626391|B1|Baseline|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
745958|NCT01626391|P2|Participant Flow|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
745959|NCT01626391|P1|Participant Flow|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
745960|NCT01626391|O2|Outcome|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
745961|NCT01626391|O1|Outcome|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
745962|NCT01626391|E2|Reported Event|Placebo|One placebo tablet containing 4-mg TRx0237 administered twice daily (8 mg/day TRx0237)
745963|NCT01626391|E1|Reported Event|TRx0237|One 125-mg TRx0237 tablet administered twice daily (250 mg/day TRx0237)
745964|NCT01626118|B5|Baseline|Total|Total of all reporting groups
745965|NCT01626118|B4|Baseline|Placebo|Placebo Group
745966|NCT01626118|B3|Baseline|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745967|NCT01626118|B2|Baseline|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745968|NCT01626118|B1|Baseline|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745971|NCT01626118|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745972|NCT01626118|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745973|NCT01626118|O4|Outcome|Placebo|Placebo Group
745974|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745975|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745976|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745977|NCT01626118|O4|Outcome|Placebo|Placebo Group
745978|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745979|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745980|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745981|NCT01626118|O4|Outcome|Placebo|Placebo Group
745982|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745983|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745984|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745985|NCT01626118|O4|Outcome|Placebo|Placebo Group
745986|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745987|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745988|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745989|NCT01626118|O4|Outcome|Placebo|Placebo Group
745990|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745991|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745992|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745993|NCT01626118|O4|Outcome|Placebo|Placebo Group
745994|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745995|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
745996|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
745997|NCT01626118|O4|Outcome|Placebo|Placebo Group
745998|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
745999|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
746000|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
746001|NCT01626118|O4|Outcome|Placebo|Placebo Group
746002|NCT01626118|O3|Outcome|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
746003|NCT01626118|O2|Outcome|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
746004|NCT01626118|O1|Outcome|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
746005|NCT01626118|E4|Reported Event|Placebo|Placebo Group
746006|NCT01626118|E3|Reported Event|Indomethacin 20 mg TID|Indomethacin Nanoformulation Capsules 20 mg TID
746007|NCT01626118|E2|Reported Event|Indomethacin 40 mg BID|Indomethacin Nanoformulation Capsules 40 mg BID
746008|NCT01626118|E1|Reported Event|Indomethacin 40 mg TID|Indomethacin Nanoformulation Capsules 40 mg TID
746009|NCT01626092|B1|Baseline|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
746010|NCT01626092|P1|Participant Flow|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
746011|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
746136|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
746012|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
746013|NCT01626092|O1|Outcome|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,"
746014|NCT01626092|E1|Reported Event|Intent-To-Treat Patients|"Patients with high-risk lysosomal and peroxisomal disorders treated with preparative regimen (Campath-1H 0.3 mg/kg intravenous (IV) on days -12 through -8, clofarabine 40 mg/m^2 IV on days -9 through -5, melphalan 140 mg/m^2 IV on day -4 and Total Body Irradiation with Marrow Boosting [ first dose of 200 cGy single dose; 5 doses of 160cGy for marrow boosting - 1000cGy cumulative exposure] by Volumetric-Modulated Arc Therapy [VMAT] on days -3 through -1). Hematopoietic stem cell transplantation will be infused on Day 0. Post-transplant immunosuppression to follow: Mycophenolate mofetil (MMF) begin day -3 and continue to day +30 or 7 days after engraftment, whichever is later; Cyclosporine A (CsA) begin day -3 and then taper at day +100 if related donor, day +180 for unrelated donor.~Campath-1H: A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8~Clofarabine: A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9"
746015|NCT01625910|B3|Baseline|Total|Total of all reporting groups
746016|NCT01625910|B2|Baseline|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
746034|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746759|NCT01620177|O1|Outcome|Cannabis - THC|Data from all dosing conditions combined to estimate the effect of THC concentrations using a regression equation.
746017|NCT01625910|B1|Baseline|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
746018|NCT01625910|P2|Participant Flow|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
746019|NCT01625910|P1|Participant Flow|Intervention - Behavioral Counseling|The intervention group received management patterned after the
746020|NCT01625910|O2|Outcome|Control|Change in cans of sugar sweetened beverages per day
746021|NCT01625910|O1|Outcome|Intervention Group|"The survey done at baseline and follow-up asked about daily cans of sugar-sweetened beverages.~Estimate is for Change in cans of sugar sweetened beverages per day"
746022|NCT01625910|O2|Outcome|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
746023|NCT01625910|O1|Outcome|Intervention - Behavioral Counseling|The intervention group received management patterned after the
746024|NCT01625910|E2|Reported Event|Control|On the day of enrollment, after randomization to the control/usual care group, the RA provided age- and ability-appropriate informational hand-outs on school readiness and/or performance.
746025|NCT01625910|E1|Reported Event|Intervention - Behavioral Counseling|"The intervention group received management patterned after the Prevention plus, Stage 1 treatment recommended by the expert panel and approved by the committee. Counseling was primarily directed toward the parents. The RA used motivational interviewing (MI) techniques as an entry way to discuss healthy lifestyle habits around eating and physical activity (e.g., open-ended questions, reflective listening, discrepancy questions, eliciting change talk). Evidence-based recommendations for childhood obesity treatment were discussed with the parent; such as, eating breakfast daily, eating ≥ 5 servings of fruits and vegetables/day, avoidance of skipping meals, watching ≤ 2 hours of screen time/day, minimizing or eliminating sugar-sweetened beverages, encouraging family meals at home, and being physically active ≥ 1 hour/day.~There were monthly follow-up phone calls to try and encourage continued success in healthy lifestyle choices."
746026|NCT01625845|B3|Baseline|Total|Total of all reporting groups
746027|NCT01625845|B2|Baseline|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746137|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746138|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746028|NCT01625845|B1|Baseline|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746029|NCT01625845|P2|Participant Flow|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746030|NCT01625845|P1|Participant Flow|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746031|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746032|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746033|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
748780|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
746035|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746036|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746037|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746038|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746039|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746040|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746041|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
748370|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
746042|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746043|NCT01625845|O2|Outcome|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746044|NCT01625845|O1|Outcome|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746045|NCT01625845|E2|Reported Event|Placebo + Standard Treatment|"Placebos: Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746046|NCT01625845|E1|Reported Event|Pentoxifylline + Standard Treatment|"Pentoxifylline: Pentoxifylline is phosphodiesterase inhibitor that interferes with proinflammatory cytokine signaling and synthesis. Participants will be instructed to take pentoxifylline 400 mg p.o. t.i.d. for 12 weeks.~Standard Treatment: Beating the Blues (BtB) is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions."
746047|NCT01625689|B3|Baseline|Total|Total of all reporting groups
746048|NCT01625689|B2|Baseline|Placebo|Inactive placebo was identical to the SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
746049|NCT01625689|B1|Baseline|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
746050|NCT01625689|P2|Participant Flow|Placebo|Inactive placebo was identical to SIIL LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
746270|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746051|NCT01625689|P1|Participant Flow|Serum Institute of India, Ltd. (SIIL) LAIV|The Serum Institute of India, Ltd. (SIIL) live attenuated influenza vaccine (LAIV) (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
746052|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
746053|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
746054|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
746055|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
746056|NCT01625689|O2|Outcome|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
746057|NCT01625689|O1|Outcome|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
746058|NCT01625689|E2|Reported Event|Placebo|Inactive placebo was identical to SII LAIV in appearance, ingredients, and concentrations, except it was missing attenuated influenza virus.
746059|NCT01625689|E1|Reported Event|SIIL LAIV|The SIIL LAIV (human, live attenuated, trivalent seasonal influenza vaccine): The viral strains in are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
746060|NCT01625507|B1|Baseline|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008"
746061|NCT01625507|P1|Participant Flow|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
746062|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746063|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746064|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746065|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746066|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
751693|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
746067|NCT01625507|O1|Outcome|PANDA Intervention|"12 week nutritional intervention, including 6 classroom/community sessions, plus two sample collection visits.~PANDA intervention: Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes (T2D), following the recommendations of the Canadian Diabetes Association, 2008"
746068|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746069|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746070|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746071|NCT01625507|O1|Outcome|All Participants|T2D patients comparing post- to pre-intervention
746072|NCT01625507|E1|Reported Event|All Participants|T2D diabetes patients
746073|NCT01625455|B3|Baseline|Total|Total of all reporting groups
746074|NCT01625455|B2|Baseline|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
746075|NCT01625455|B1|Baseline|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
746076|NCT01625455|P2|Participant Flow|Aprepitant Then Placebo.|These subjects received aprepitant during the first week and then crossed over to placebo for the second week.
746077|NCT01625455|P1|Participant Flow|Placebo Then Aprepitant|These subjects received placebo during the first week and then crossed over to aprepitant for the second week.
746078|NCT01625455|O2|Outcome|Placebo|"Matching placebo will be given in place of aprepitant~Placebo: Placebo will be given orally for a total of 7 days."
746079|NCT01625455|O1|Outcome|Aprepitant|"Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.~Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days."
746080|NCT01625455|O2|Outcome|Placebo|"Matching placebo will be given in place of aprepitant~Placebo: Placebo will be given orally for a total of 7 days."
746081|NCT01625455|O1|Outcome|Aprepitant|"Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.~Aprepitant: Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days."
746082|NCT01625455|E2|Reported Event|Aprepitant|
746083|NCT01625455|E1|Reported Event|Placebo|
746084|NCT01625377|B3|Baseline|Total|Total of all reporting groups
746100|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746309|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
754253|NCT01587079|O7|Outcome|FF MDI 9.6 μg|9.6 μg
746085|NCT01625377|B2|Baseline|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746086|NCT01625377|B1|Baseline|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746087|NCT01625377|P2|Participant Flow|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746088|NCT01625377|P1|Participant Flow|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746089|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746090|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746091|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746092|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746093|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746094|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746095|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746096|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746097|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746098|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746099|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746101|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746102|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746103|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746104|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746105|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746106|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746107|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746108|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746139|NCT01625338|E3|Reported Event|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
748371|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
746109|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746110|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746111|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746112|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746113|NCT01625377|O2|Outcome|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746114|NCT01625377|O1|Outcome|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746179|NCT01624740|B2|Baseline|High Rate Followed By Low Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
746115|NCT01625377|E2|Reported Event|Everolimus (RAD001)|"From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids.~From randomization to month 6 : everolimus (recommended starting dose of 2 mg/day, then adjusted to achieve the target 6 ≤ C0 ≤ 10 ng/mL, until W24) + mycophenolic acid 1440 mg/d ± oral corticosteroids. The dose of tacrolimus was reduced by 50% twice: at the introduction of everolimus and at week 8 post-transplantation. Tacrolimus had to be finally discontinued in week 12 post-transplantation (by week 16 at the latest)."
746116|NCT01625377|E1|Reported Event|Tacrolimus|From transplantation to randomization: Basiliximab (20mg) at Day 0 and Day 4 + tacrolimus (C0 6-10 ng/ml) from Day 3-Day 5 + mycophenolic acid 1440 mg/d ± oral corticosteroids. From randomization to month 6 : tacrolimus (C0 6-10 ng/ml) + mycophenolic acid 1440 mg/d ± oral corticosteroids
746117|NCT01625338|B4|Baseline|Total|Total of all reporting groups
746118|NCT01625338|B3|Baseline|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
746119|NCT01625338|B2|Baseline|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746120|NCT01625338|B1|Baseline|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746121|NCT01625338|P3|Participant Flow|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly for 12 weeks in participants
746122|NCT01625338|P2|Participant Flow|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746123|NCT01625338|P1|Participant Flow|SOF+RBV 12 Weeks|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746124|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
746125|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746126|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746127|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
746128|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746129|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746130|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
746131|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746132|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746133|NCT01625338|O3|Outcome|SOF+RBV+Peg-IFN 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) + Peg-IFN 180 µg administered subcutaneously once weekly for 12 weeks in participants
746134|NCT01625338|O2|Outcome|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746135|NCT01625338|O1|Outcome|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746206|NCT01624350|P1|Participant Flow|Permacol Collagen Paste|
746140|NCT01625338|E2|Reported Event|SOF+RBV 24 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 24 weeks
746141|NCT01625338|E1|Reported Event|SOF+RBV 12 Weeks|SOF 400 mg tablet once daily + RBV tablets (1000 or 1200 mg daily based on weight) for 12 weeks
746142|NCT01625221|B1|Baseline|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
746143|NCT01625221|P1|Participant Flow|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
746144|NCT01625221|O1|Outcome|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
746145|NCT01625221|E1|Reported Event|Magnetic Anal Sphincter Augmentation|"The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.~Magnetic Anal Sphincter: The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision."
754254|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
746146|NCT01625169|B1|Baseline|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14.~There is only one arm- all pregnant women enrolled into the study will receive Etravirine 200mg PO bid for 14 days postpartum"
746147|NCT01625169|P1|Participant Flow|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746148|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746149|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746150|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746151|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746152|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746153|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746154|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746155|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746156|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746157|NCT01625169|O1|Outcome|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746158|NCT01625169|E1|Reported Event|HIV + Pregnant Women|"Etravirine PK on days 5 and 14~Etravirine pharmacokinetics in breast milk and plasma: HIV+ pregnant women will receive etravirine for 14 days postpartum. PK will be done on postpartum days 5 and 14."
746159|NCT01624948|B3|Baseline|Total|Total of all reporting groups
746160|NCT01624948|B2|Baseline|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
746207|NCT01624350|O5|Outcome|Permacol Collagen Paste - 12 Month Post-op|
746208|NCT01624350|O4|Outcome|Permacol Collagen Paste - 6 Month Post-op|
746209|NCT01624350|O3|Outcome|Permacol Collagen Paste - 3 Month Post-op|
746161|NCT01624948|B1|Baseline|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
746162|NCT01624948|P2|Participant Flow|Standard of Care: 50% Reduction of Mycophenolic Acid (MPA)|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BK polyomavirus (BKV) infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
746163|NCT01624948|P1|Participant Flow|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo mycophenolic acid (MPA) discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
746164|NCT01624948|O2|Outcome|No Rejection|No biopsy-proven rejection episode
746165|NCT01624948|O1|Outcome|Rejection|Any biopsy-proven rejection episode
746238|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
754255|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
746166|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
746167|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
746168|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
746169|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
746170|NCT01624948|O2|Outcome|Failed to Reach Primary Endpoint|
746171|NCT01624948|O1|Outcome|Reached Primary Endpoint|>50% reduction of BKV viruria and/or clearance of BKV viremia
746172|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
746173|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
746174|NCT01624948|O2|Outcome|Standard of Care: 50% Reduction of MPA|"This arm (group 2) patients will continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels will be re-checked. Renal allograft biopsies will be done for cause as clinically indicated.~Mycophenolic acid dose reduction: Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone."
746175|NCT01624948|O1|Outcome|Everolimus+Tacrolimus/Prednisone|"This arm (group 1) will undergo MPA discontinuation with the addition of Zortress (everolimus) to their current regimen of tacrolimus and prednisone; All patients in group 1 will receive Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.~Everolimus: Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL."
746176|NCT01624948|E2|Reported Event|Standard of Care: 50% Reduction of MPA|Mycophenolic acid dose reduction: continue with tacrolimus (target trough level of 6-10 ng/mL), prednisone, and undergo a 50% reduction of the MPA dose, which is the standard immunosuppression treatment for renal transplant recipients with evidence of BKV infection. At months 1, 2, and 3 post-randomization urine and plasma BKV levels re-checked. Renal allograft biopsies will be done for cause as clinically indicated.
746177|NCT01624948|E1|Reported Event|Everolimus+Tacrolimus/Prednisone|Everolimus: MPA discontinuation with the addition of Zortress (everolimus) to current regimen of tacrolimus and prednisone; Zortress (everolimus) at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
746178|NCT01624740|B3|Baseline|Total|Total of all reporting groups
746367|NCT01623115|B1|Baseline|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746180|NCT01624740|B1|Baseline|Low Rate Followed By High Rate|Precision Plus Spinal Cord Stimulation system: The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
746181|NCT01624740|P2|Participant Flow|High Rate Followed By Low Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 1200 Hz stimulation for 3-4 days, followed by 2 Hz stimulation for another 3-4 days.
746182|NCT01624740|P1|Participant Flow|Low Rate Followed By High Rate|The Precision Plus spinal cord stimulation screening trial leads were temporarily implanted by the investigator. Subjects in this group first received 2 Hz stimulation for 3-4 days, followed by 1200 Hz stimulation for another 3-4 days.
746183|NCT01624740|O2|Outcome|High Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 1200 Hz as either a first or second intervention.
746184|NCT01624740|O1|Outcome|Low Rate Subperception Precision SCS Trial Therapy|Stimulation was given at a rate of 2 Hz as either a first or second intervention.
746185|NCT01624740|E3|Reported Event|High Frequency Stimulation|Stimulation was given at 1200 Hz.
746186|NCT01624740|E2|Reported Event|Low Frequency Stimulation|Stimulation was given at 2 Hz.
746187|NCT01624740|E1|Reported Event|Trial Lead Insertion|All subjects (n = 20) underwent a lead insertion procedure prior to beginning Period 1 of stimulation. Two of these subjects did not proceed to Period 1 due to insertion difficulties.
746188|NCT01624467|B1|Baseline|Necitumumab|800 mg necitumumab, administered once per week IV
746189|NCT01624467|P1|Participant Flow|Necitumumab|800 milligram (mg) necitumumab, administered once per week as an intravenous infusion (IV)
746190|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
746191|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
746192|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
746193|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
746194|NCT01624467|O2|Outcome|Necitumumab: Cycle 1, Day 36|800 mg necitumumab, administered once per week IV
746195|NCT01624467|O1|Outcome|Necitumumab: Cycle 1, Day 1|800 mg necitumumab, administered once per week IV
746196|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
746197|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
746198|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
746199|NCT01624467|O1|Outcome|Necitumumab|800 mg necitumumab, administered once per week IV
746200|NCT01624467|E1|Reported Event|Necitumumab|800 mg necitumumab, administered once per week as an intravenous infusion (IV)
746201|NCT01624363|B1|Baseline|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
746202|NCT01624363|P1|Participant Flow|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
746203|NCT01624363|O1|Outcome|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
746204|NCT01624363|E1|Reported Event|Patients Undergoing EUS|"Patients undergoing EUS for non-pancreatic treatment.~Diagnosis of a previously undetected pancreatic cyst: patients identified to have a pancreatic cyst, will need to be followed via imaging studies."
746205|NCT01624350|B1|Baseline|Permacol Collagen Paste|
746226|NCT01624259|B2|Baseline|Liraglutide|"Liraglutide 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
746227|NCT01624259|B1|Baseline|LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
746228|NCT01624259|P2|Participant Flow|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
746229|NCT01624259|P1|Participant Flow|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
746230|NCT01624259|O2|Outcome|Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
746231|NCT01624259|O1|Outcome|LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 mg/day, oral, for 26 weeks"
746232|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746233|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746234|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746235|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746236|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746237|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746407|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746239|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746240|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746241|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746242|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746243|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746244|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746245|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746246|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746247|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746248|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746249|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746250|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746251|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746252|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746253|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746254|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746255|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746256|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746257|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746258|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746259|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746260|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746261|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746262|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746263|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746264|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746265|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746266|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746267|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746268|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746269|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746921|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746271|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746272|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746273|NCT01624259|O2|Outcome|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746274|NCT01624259|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746275|NCT01624259|E2|Reported Event|1.8 mg Liraglutide|"Liraglutide: 0.6 mg, SC, once daily for 7 days, then titrated up to 1.2 mg, SC, once daily for 7 days, then titrated up to 1.8 mg, SC, once daily for 24 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746276|NCT01624259|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 mg, SC, once weekly for 26 weeks~Metformin: at least 1500 mg/day, administered orally, for 26 weeks"
746277|NCT01624233|B1|Baseline|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746278|NCT01624233|P1|Participant Flow|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).~Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks."
746279|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746280|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746281|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746391|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
748372|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
746282|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746283|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746284|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746285|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746286|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746475|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of pharmacokinetic (PK) sampling
746287|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746288|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746289|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746290|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746291|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746292|NCT01624233|O1|Outcome|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746293|NCT01624233|E1|Reported Event|80 mg Ixekizumab (LY2439821)|"Ixekizumab:~Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).~Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks."
746294|NCT01624168|B4|Baseline|Total|Total of all reporting groups
746295|NCT01624168|B3|Baseline|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746296|NCT01624168|B2|Baseline|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746297|NCT01624168|B1|Baseline|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746298|NCT01624168|P3|Participant Flow|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746299|NCT01624168|P2|Participant Flow|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746300|NCT01624168|P1|Participant Flow|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746301|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746302|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746303|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746304|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746305|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746306|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746307|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746308|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746476|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
746310|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746311|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746312|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746313|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746314|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746315|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746316|NCT01624168|O3|Outcome|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746317|NCT01624168|O2|Outcome|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746318|NCT01624168|O1|Outcome|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746319|NCT01624168|E3|Reported Event|Enhanced Tai Chi Instruction|"10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice~Enhanced tai chi instruction: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice"
746320|NCT01624168|E2|Reported Event|10 Week Tai Chi Intervention|"10 week course in Evidence Based Tai Chi meeting 2 times per week~10 week tai chi intervention: 10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week"
746321|NCT01624168|E1|Reported Event|Anxiety Management Education|Anxiety Management Education: written materials on management of anxiety for self-study
746322|NCT01623869|B1|Baseline|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
746323|NCT01623869|P1|Participant Flow|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
746324|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
746325|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
746326|NCT01623869|O1|Outcome|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
746327|NCT01623869|E1|Reported Event|Treatment (Trebananib)|Patients receive 30 mg/kg trebananib IV over 30-60 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
746328|NCT01623830|B3|Baseline|Total|Total of all reporting groups
746329|NCT01623830|B2|Baseline|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746330|NCT01623830|B1|Baseline|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746331|NCT01623830|P2|Participant Flow|Neutral Cue + VRE|"VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
746332|NCT01623830|P1|Participant Flow|Reactivation + VRE|"Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.~Virtual Reality Exposure Therapy: Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment."
746333|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746334|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746335|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746336|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
748781|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
746337|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746338|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746339|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746340|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746341|NCT01623830|O2|Outcome|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746342|NCT01623830|O1|Outcome|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746343|NCT01623830|E2|Reported Event|Neutral Cue + VRE|VRE for the FOF preceded by a neutral cue (a virtual reality clip of a virtual living room) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746344|NCT01623830|E1|Reported Event|Reactivation + VRE|Virtual reality exposure therapy (VRE) for the fear of flying (FOF) preceded by a reminder of the feared stimulus (a virtual reality clip of a virtual airplane taxiing and taking off) presented in the head mounted display 10 minutes prior to all VR exposure therapy sessions.
746345|NCT01623479|B1|Baseline|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
746346|NCT01623479|P1|Participant Flow|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
746347|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
746348|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
746349|NCT01623479|O1|Outcome|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
746350|NCT01623479|E1|Reported Event|Hypotrichosis of the Eyelashes|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
746351|NCT01623323|B1|Baseline|OPN-375|OPN-375 400 mcg/twice daily
746352|NCT01623323|P1|Participant Flow|OPN-375|OPN-375 400 mcg/twice daily
746353|NCT01623323|O1|Outcome|OPN-375|OPN-375 400 mcg/twice daily
746354|NCT01623323|E1|Reported Event|OPN-375|OPN-375 400 mcg/twice daily
746355|NCT01623271|B1|Baseline|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
746356|NCT01623271|P1|Participant Flow|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
746357|NCT01623271|O1|Outcome|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
746358|NCT01623271|E1|Reported Event|CRPS I Pain Subjects|"This is an open label study that involves taking Gralise pills (gastic-retentive gabapentin) for 8 weeks.~Day 1-15: Titration phase- titrate Gralise from 300 mg/day to 1800 mg/day Day 16-42: Maintenance phase- maintain the dose of 1800 mg/day Day 43-56: Taper phase- taper the Gralise from 100 mg/day to 300 mg/day"
746359|NCT01623154|B1|Baseline|BreathTek UBT|Comparison of urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT-IR300. UBiT-IR300 is the FDA approved device.
746360|NCT01623154|P1|Participant Flow|Urea Hydrolysis Rate (UHR)|"Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone and UBiT -IR300~Same patients will be tested on both the POCone and UBiT-IR300"
746361|NCT01623154|O2|Outcome|POCone|This is the device being tested and compared to the FDA approved device.
746362|NCT01623154|O1|Outcome|UBiT-IR300|This is the FDA approved device.
746363|NCT01623154|O1|Outcome|Urea Hydrolysis Rate (UHR) Values|Urea hydrolysis rate (UHR) values derived from Delta over Baseline (DOB)values obtained from the POCone compared to the the approved device, UBiT-IR300. Three regression analyses completed (Deming, Passing-Bablok and Regular regression).
746364|NCT01623154|E1|Reported Event|Pranactin Citric Solution|At each visit, each subject provided baseline breath samples by exhaling into the mouthpiece of the 3 Baseline bags (Blue bags, labeled A,B, C according to collection order), received one 4 oz administration of Pranctin Citric solution (mixed in water, drink using a straw), waited 15 minutes and provided the Post-Dose breath samples (Pink bags, labeled A, B, C). The Blue and Pink bags were paired and tested in no particular order on each instrument. The subjects who tested positive for H.pylori underwent a second set of tests 28 days after completion of eradication therapy.
746365|NCT01623115|B3|Baseline|Total|Total of all reporting groups
746366|NCT01623115|B2|Baseline|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
754256|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
746368|NCT01623115|P2|Participant Flow|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when low-density lipoprotein cholesterol (LDL-C) levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746369|NCT01623115|P1|Participant Flow|Placebo|Placebo for alirocumab subcutaneous (SC) injection every 2 weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
746370|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746371|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746372|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746373|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746374|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746375|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746376|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746377|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746378|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746379|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746380|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746381|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746382|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746383|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746384|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746385|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746386|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746387|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746388|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746389|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746390|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746392|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746393|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746394|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746395|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746396|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746397|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746398|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746399|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746400|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746401|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746402|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746403|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746404|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746405|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746406|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746408|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746409|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746410|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746411|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746412|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746413|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746414|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746415|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746416|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746417|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746418|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746419|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746420|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746421|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746422|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746423|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746424|NCT01623115|O2|Outcome|Alirocumab 75 mg/Up to 150 mg Q2W|Alirocumab 75 mg SC injection Q2W on top of stable LMT for 78 weeks. Alirocumab dose up-titrated to 150 mg from Week 12 when LDL-C levels ≥ 70 mg/dL (1.81 mmol/L) at Week 8.
746425|NCT01623115|O1|Outcome|Placebo|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746426|NCT01623115|E2|Reported Event|Alirocumab 75/Up to 150 mg Q2W|Participants exposed to Alirocumab 75 mg/Up to 150 mg Q2W on top of stable LMT (mean exposure of 72 weeks).
746427|NCT01623115|E1|Reported Event|Placebo|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 72 weeks).
746428|NCT01623050|B1|Baseline|SinuSys Dilation System|"Maxillary Sinus Dilation~SinuSys Dilation System: Sinuplasty"
746429|NCT01623050|P1|Participant Flow|SinuSys Dilation System|Maxillary Sinus Dilation
746430|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
746431|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
746432|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
746433|NCT01623050|O1|Outcome|SinuSys Dilation System|Maxillary Sinus Dilation
746437|NCT01622673|B6|Baseline|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746438|NCT01622673|B5|Baseline|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746439|NCT01622673|B4|Baseline|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746440|NCT01622673|B3|Baseline|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746441|NCT01622673|B2|Baseline|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746442|NCT01622673|B1|Baseline|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
746477|NCT01622673|E5|Reported Event|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
749999|NCT01605877|O3|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
746443|NCT01622673|P6|Participant Flow|MINTOX+RAL, TUMS+RAL, RAL, MINTOX After RAL, MINTOX Before RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746444|NCT01622673|P5|Participant Flow|TUMS+RAL, RAL, MINTOX+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746445|NCT01622673|P4|Participant Flow|RAL, MINTOX+RAL, TUMS+RAL, MINTOX After RAL, MINTOX Before RAL|Participants received Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours after Raltegravir in treatment period 4, followed by MINTOX® 2 hours before Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746446|NCT01622673|P3|Participant Flow|MINTOX+RAL, RAL, TUMS+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received MINTOX® + Raltegravir in treatment period 1, followed by Raltegravir in treatment period 2, followed by TUMS® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746447|NCT01622673|P2|Participant Flow|TUMS+RAL, MINTOX+RAL, RAL, MINTOX Before RAL, MINTOX After RAL|Participants received TUMS® + Raltegravir in treatment period 1, followed by MINTOX® + Raltegravir in treatment period 2, followed by Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a minimum 2-day washout between treatment periods.
746448|NCT01622673|P1|Participant Flow|RAL, TUMS+RAL, MINTOX+RAL, MINTOX Before RAL, MINTOX After RAL|Participants received Raltegravir in treatment period 1, followed by TUMS® + Raltegravir in treatment period 2, followed by MINTOX® + Raltegravir in treatment period 3, followed by MINTOX® 2 hours before Raltegravir in treatment period 4, followed by MINTOX® 2 hours after Raltegravir in treatment period 5. There was a 2-day washout between treatment periods.
746449|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of AE assessment
746450|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of AE assessment
746451|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of AE assessment
746452|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of AE assessment
746453|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
746454|NCT01622673|O5|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
746455|NCT01622673|O4|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
746456|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
746457|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
746458|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
751694|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
746459|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
746460|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
746461|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
746462|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
746463|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
746464|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
746465|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
746466|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
746467|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
746468|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
746469|NCT01622673|O2|Outcome|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
746470|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
746471|NCT01622673|O3|Outcome|MINTOX® After Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours after raltegravir on the day of PK sampling
746472|NCT01622673|O2|Outcome|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
746473|NCT01622673|O1|Outcome|Raltegravir|Raltegravir 400 mg every 12 hours
746474|NCT01622673|O3|Outcome|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
746478|NCT01622673|E4|Reported Event|MINTOX® Before Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was administered 2 hours before raltegravir on the day of PK sampling
746479|NCT01622673|E3|Reported Event|MINTOX® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of MINTOX® 20 mL was coadministered with raltegravir on the day of PK sampling
746480|NCT01622673|E2|Reported Event|TUMS® + Raltegravir|Raltegravir 400 mg every 12 hours. A single dose of TUMS® 1000 mg (3 tablets) was coadministered with raltegravir on the day of PK sampling
746481|NCT01622673|E1|Reported Event|Raltegravir|Raltegravir 400 mg every 12 hours
746482|NCT01622296|B1|Baseline|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
746483|NCT01622296|P2|Participant Flow|Buffered Lidocaine First, Then Lidocaine|buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
746484|NCT01622296|P1|Participant Flow|Lidocaine First, Then Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine. Two treatment visits were required to complete bilateral dental operative restorations. At each visit, local anesthetic was delivered to the right or left side of the dentition using one of the two anesthetic types. The second injection/treatment appointment was at least 1 week after the first treatment.
746485|NCT01622296|O2|Outcome|Buffered Lidocaine|2% buffered lidocaine with 1:100,000 ppm epinephrine
746486|NCT01622296|O1|Outcome|Lidocaine|2% lidocaine with 1:100,000 ppm epinephrine
746487|NCT01622296|E1|Reported Event|Crossover Lidocaine/Buffered Lidocaine|lidocaine 2% with 1:100,000 epinephrine followed by buffered lidocaine 2% with 1:100,000 epinephrine or buffered lidocaine 2% with 1:100,000 epinephrine followed by lidocaine 2% with 1:100,000 epinephrine
746488|NCT01622257|B4|Baseline|Total|Total of all reporting groups
746489|NCT01622257|B3|Baseline|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746490|NCT01622257|B2|Baseline|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
746491|NCT01622257|B1|Baseline|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746492|NCT01622257|P3|Participant Flow|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746493|NCT01622257|P2|Participant Flow|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
746494|NCT01622257|P1|Participant Flow|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746495|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746496|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
746497|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746498|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746499|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
747190|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
746500|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746501|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746502|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
746503|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746504|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746505|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
746506|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746507|NCT01622257|O3|Outcome|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746508|NCT01622257|O2|Outcome|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
746509|NCT01622257|O1|Outcome|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746510|NCT01622257|E3|Reported Event|Cavitation US + Metformin|Combination of both Cavitation US + Metformin
746511|NCT01622257|E2|Reported Event|Metformin|Metformin oral tablets 500 mg were given three times daily for 3 months
746512|NCT01622257|E1|Reported Event|Cavitation US|Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
746513|NCT01622231|B1|Baseline|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746514|NCT01622231|P1|Participant Flow|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746515|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746516|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746517|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746518|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
750000|NCT01605877|O2|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
746519|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746520|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746521|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746522|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746523|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746524|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746525|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746526|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746527|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746528|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746529|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746530|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746531|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746532|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746533|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746534|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746535|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746536|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746537|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746538|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746539|NCT01622231|O1|Outcome|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746540|NCT01622231|E1|Reported Event|GW685698X 55 μg QD|Participants received GW685698X nasal spray (55 micrograms [µg]) as one spray into each nostril (27.5 μg per spray) once daily (QD) in the morning for 12 weeks.
746541|NCT01621776|B4|Baseline|Total|Total of all reporting groups
746542|NCT01621776|B3|Baseline|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
746543|NCT01621776|B2|Baseline|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746544|NCT01621776|B1|Baseline|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746545|NCT01621776|P3|Participant Flow|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
746546|NCT01621776|P2|Participant Flow|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746547|NCT01621776|P1|Participant Flow|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746548|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
746549|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746550|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746551|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
746552|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746553|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746554|NCT01621776|O3|Outcome|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
746555|NCT01621776|O2|Outcome|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746556|NCT01621776|O1|Outcome|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746557|NCT01621776|E3|Reported Event|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
746558|NCT01621776|E2|Reported Event|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746559|NCT01621776|E1|Reported Event|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
746560|NCT01621672|B3|Baseline|Total|Total of all reporting groups
746561|NCT01621672|B2|Baseline|Observation|No treatment
746562|NCT01621672|B1|Baseline|Revlimid|Revlimid: 10 mg/day in the morning same time each day
746563|NCT01621672|P2|Participant Flow|Observation|No treatment
746564|NCT01621672|P1|Participant Flow|Revlimid|Revlimid: 10 mg/day in the morning same time each day
746565|NCT01621672|O2|Outcome|Observation|No treatment
746566|NCT01621672|O1|Outcome|Revlimid|Revlimid: 10 mg/day in the morning same time each day
746567|NCT01621672|E2|Reported Event|Observation|No treatment
746568|NCT01621672|E1|Reported Event|Revlimid|Revlimid: 10 mg/day in the morning same time each day
746569|NCT01621633|B5|Baseline|Total|Total of all reporting groups
746570|NCT01621633|B4|Baseline|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
746571|NCT01621633|B3|Baseline|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
746572|NCT01621633|B2|Baseline|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746573|NCT01621633|B1|Baseline|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746574|NCT01621633|P4|Participant Flow|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
746575|NCT01621633|P3|Participant Flow|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
746576|NCT01621633|P2|Participant Flow|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746577|NCT01621633|P1|Participant Flow|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746578|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
746579|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
746580|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746581|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746582|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
746583|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
746584|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746585|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746586|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
746587|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
746588|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746589|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746590|NCT01621633|O4|Outcome|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
746591|NCT01621633|O3|Outcome|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
746592|NCT01621633|O2|Outcome|Participants With Moderate Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746593|NCT01621633|O1|Outcome|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746594|NCT01621633|E4|Reported Event|Participants With Mild Hepatic Impairment (HI)|LCZ696 200 mg, given as a single oral dose
746595|NCT01621633|E3|Reported Event|Healthy Volunteers (Moderate HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 2
746596|NCT01621633|E2|Reported Event|Healthy Volunteers (Mild HI Matched)|LCZ696 200 mg, given as a single oral dose. Each healthy volunteer matched in race, age (±5 years), gender, weight (±15%) to an individual subject with hepatic impairment in group 1
746597|NCT01621633|E1|Reported Event|Moderate Hepatic Impaired Patients|Moderate hepatic impaired patients
746598|NCT01621477|B1|Baseline|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
746599|NCT01621477|P1|Participant Flow|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746600|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746601|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746602|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746603|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746604|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746605|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746606|NCT01621477|O1|Outcome|Treatment|Study participants (excluding donors) who were enrolled and underwent transplant.
746607|NCT01621477|E1|Reported Event|Treatment|Study participants (excluding donors) who were enrolled to receive treatment with clofarabine, cytarabine, busulfan, plerixafor, cyclophosphamide, antithymocyte globulin (rabbit), stem cells, tacrolimus, and mycophenolate mofetil. Donors did not receive treatment and are not followed for data collection to answer the study objectives. They are therefore not included in the results reported here.
746608|NCT01621191|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
747191|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746609|NCT01621191|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to a 60-milligram (mg) dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
746610|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
746611|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
746612|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
746613|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
746614|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
746615|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
746922|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746616|NCT01621191|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).
746617|NCT01621191|O1|Outcome|Duloxetine 60 mg|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
746618|NCT01621191|E1|Reported Event|60 mg Duloxetine|"Treatment Period: Up to a 60-mg dose of duloxetine was administered orally once daily for 50 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule), Week 2: 40-mg dose of duloxetine (two 20-mg capsules), and Weeks 3 through 50: 60-mg dose of duloxetine (three 20-mg capsules).~During the 2-week taper, the daily dosage was gradually reduced. For the first week: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the second week: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
746619|NCT01621126|B1|Baseline|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
746620|NCT01621126|P1|Participant Flow|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
746621|NCT01621126|O1|Outcome|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
746646|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
748373|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
746622|NCT01621126|E1|Reported Event|Intra-op Neuromonitoring|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor): Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
746623|NCT01621009|B5|Baseline|Total|Total of all reporting groups
746624|NCT01621009|B4|Baseline|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
746625|NCT01621009|B3|Baseline|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
746626|NCT01621009|B2|Baseline|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
746627|NCT01621009|B1|Baseline|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
746628|NCT01621009|P4|Participant Flow|Placebo Medication, No Counseling|Placebo bupropion, No counseling, just medication checks
746629|NCT01621009|P3|Participant Flow|Placebo Medication + Counseling|Placebo bupropion plus eight 10-minute individual counseling sessions
746630|NCT01621009|P2|Participant Flow|Active Bupropion , No Counseling|Active bupropion, No counseling, only medication checks
746631|NCT01621009|P1|Participant Flow|Active Bupropion + Counseling|Active bupropion SR plus eight 10-minute individual counseling sessions.
746632|NCT01621009|O4|Outcome|Placebo, No Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~No cessation counseling, medication management and assessment only."
746633|NCT01621009|O3|Outcome|Placebo + Counseling|": Medications: Pre-quit - Placebo bupropion one per day 3 days before quit day, then two per day 4 days before quit day; placebo bupropion twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
746634|NCT01621009|O2|Outcome|Bupropion, No Counseling|Active bupropion, No counseling: Medications: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date. No cessation counseling, medication management and assessment only.
746757|NCT01620177|O3|Outcome|THC x BrAC|Data from all dosing conditions combined to estimate the interactive effect of THC and BrAC concentrations using a regression equation.
746635|NCT01621009|O1|Outcome|Bupropion + Counseling|"Active bupropion + 8 weeks counseling: Medications: Pre-quit - 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.~Counseling: Pre-quit - Two 10-minute sessions; Post-quit: Eight weekly 10-minute sessions"
746636|NCT01621009|E2|Reported Event|Active Medication|Pre-quit – 150mg bupropion SR per day 3 days before quit day, then 150mg twice a day 4 days before quit day; 150mg bupropion SR twice daily for 8 weeks after the quit date.
746637|NCT01621009|E1|Reported Event|Placebo Medication|Medications: Pre-quit – one placebo pill for 3 days before quit day, then one placebo pill twice a day 4 days before quit day for 8 weeks after the quit date.
746638|NCT01620489|B3|Baseline|Total|Total of all reporting groups
746639|NCT01620489|B2|Baseline|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746640|NCT01620489|B1|Baseline|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746641|NCT01620489|P2|Participant Flow|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746642|NCT01620489|P1|Participant Flow|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746643|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746644|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746645|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
747192|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
751695|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
746647|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746648|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746649|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746650|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746651|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746652|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746653|NCT01620489|O2|Outcome|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746654|NCT01620489|O1|Outcome|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746655|NCT01620489|E2|Reported Event|Placebo|Subjects received s.c placebo 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial OAD and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746656|NCT01620489|E1|Reported Event|Lira 1.8 mg|Subjects received subcutaneous (s.c) liraglutide 1.8 mg once daily, applying a 3−4 week dose escalation regimen with weekly increments of 0.6 mg until the maintenance dose of 1.8 mg was reached, as an add-on to the subject’s stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen (monotherapy or any duo-combinations of metformin and/or sulphonylureas and/or pioglitazone; or monotherapy of basal or premix insulin or combination with metformin and/or pioglitazone).
746657|NCT01620255|B6|Baseline|Total|Total of all reporting groups
746658|NCT01620255|B5|Baseline|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746659|NCT01620255|B4|Baseline|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746660|NCT01620255|B3|Baseline|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746661|NCT01620255|B2|Baseline|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746662|NCT01620255|B1|Baseline|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746663|NCT01620255|P5|Participant Flow|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746664|NCT01620255|P4|Participant Flow|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746665|NCT01620255|P3|Participant Flow|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746666|NCT01620255|P2|Participant Flow|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746667|NCT01620255|P1|Participant Flow|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 centimeters (cm) apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746668|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746669|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746670|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746671|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746672|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746673|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746674|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746675|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746676|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746677|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
748374|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
746678|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746679|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746680|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746681|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746682|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746683|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746684|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746685|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746686|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746687|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746688|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746689|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746690|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746691|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746692|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
747193|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746693|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746694|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746695|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746696|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746697|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746698|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746699|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746700|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746701|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746702|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746703|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746704|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746705|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746706|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746707|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
747194|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
746708|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746709|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746710|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746711|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746712|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746713|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746714|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746715|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746716|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746717|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746718|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746719|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746720|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746721|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746722|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
747195|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746723|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746724|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746725|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746726|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746727|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746728|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746729|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746730|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746731|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746732|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746733|NCT01620255|O5|Outcome|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746734|NCT01620255|O4|Outcome|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746735|NCT01620255|O3|Outcome|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746736|NCT01620255|O2|Outcome|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746737|NCT01620255|O1|Outcome|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
747196|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
746738|NCT01620255|E5|Reported Event|PF-00547659 225 mg|Participants received PF-00547659 225 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 225 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746739|NCT01620255|E4|Reported Event|PF-00547659 75 mg|Participants received PF-00547659 75 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 75 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746740|NCT01620255|E3|Reported Event|PF-00547659 22.5 mg|Participants received PF-00547659 22.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 22.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746741|NCT01620255|E2|Reported Event|PF-00547659 7.5 mg|Participants received PF-00547659 7.5 milligrams (mg) in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered PF-00547659 7.5 mg SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746742|NCT01620255|E1|Reported Event|Placebo|Participants received placebo in the form of 3 subcutaneous (SC) injections on Days 1, 28, and 56, following the completion of most study procedures. Participants were administered placebo SC in the anterolateral right or left thighs. Injections were administered at least 3 cm apart to the same thigh beginning from the outermost section of the thigh OR 2 injections in 1 thigh about 3 cm apart and 1 in the other thigh.
746743|NCT01620177|B1|Baseline|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated.
746758|NCT01620177|O2|Outcome|Alcohol - BrAC (Breath Alcohol Concentration)|Data from all dosing conditions combined to estimate the effect of BrACconcentrations using a regression equation.
746744|NCT01620177|P1|Participant Flow|Overall Study|Individuals who completed the study completed all six arms of the study and the data is aggregated. Non-completers may have completed some arms and not others and their data is aggregated. There will be six study visits where the subject will arrive at the Clinical Research Unit(University of Iowa Hospitals & Clinics) the night before dosing. At each visit subjects will be receive one of the following six dosing regimens: placebo alcohol with placebo cannabis; placebo alcohol with low-dose cannabis, placebo alcohol with higher-dose of cannabis, low dose alcohol with placebo cannabis; low dose alcohol with low dose cannabis, low dose alcohol with higher-dose of cannabis.
746745|NCT01620177|O6|Outcome|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746746|NCT01620177|O5|Outcome|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746747|NCT01620177|O4|Outcome|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746748|NCT01620177|O3|Outcome|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746749|NCT01620177|O2|Outcome|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746750|NCT01620177|O1|Outcome|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746751|NCT01620177|O6|Outcome|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746803|NCT01620060|E1|Reported Event|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
746804|NCT01620047|B4|Baseline|Total|Total of all reporting groups
746752|NCT01620177|O5|Outcome|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746753|NCT01620177|O4|Outcome|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746754|NCT01620177|O3|Outcome|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746755|NCT01620177|O2|Outcome|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746756|NCT01620177|O1|Outcome|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746923|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746760|NCT01620177|E6|Reported Event|0% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746761|NCT01620177|E5|Reported Event|6.0-7.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746762|NCT01620177|E4|Reported Event|2.5-3.5% THC With 0 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746763|NCT01620177|E3|Reported Event|6.0-7.5% THC and 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746764|NCT01620177|E2|Reported Event|2.5-3.5% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746765|NCT01620177|E1|Reported Event|0% THC With 0.065 g/dL BAC|"Alcohol(oral) and placebo: Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive~Cannabis(THC)(Inhaled) and Placebo: Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC"
746766|NCT01620138|B3|Baseline|Total|Total of all reporting groups
746767|NCT01620138|B2|Baseline|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
751696|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
746768|NCT01620138|B1|Baseline|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated clinically by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
746769|NCT01620138|P2|Participant Flow|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
746770|NCT01620138|P1|Participant Flow|Pasireotide|"Non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~Patients with a nonfunctioning pituitary adenoma (NFPA), treatment will be started at least 3 months after neurosurgery. The efficacy will be evaluated by MRI 6 months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After 4 weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for 6 months."
746841|NCT01619787|P1|Participant Flow|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
746771|NCT01620138|O2|Outcome|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
746772|NCT01620138|O1|Outcome|Pasireotide|"For non-cured patients with resistant prolactinomas, MRI will be performed immediately before and six months after the onset of pasireotide. The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
746773|NCT01620138|E2|Reported Event|Cabergoline|"In patients with non-functioning pituitary adenoma, treatment will be started at least 3 months after neurosurgery. The drug response will be evaluated clinically by visual field and by Magnetic resonance imaging (MRI) before medical treatment and after six months of cabergoline treatment at maximum dose.~cabergoline: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
746774|NCT01620138|E1|Reported Event|Pasireotide|"For non-cured patients with resistant prolactinomas , MRI will be performed immediately before and six months after the onset of pasireotide . The efficacy will be evaluated by prolactin dosage every month.~For patients harboring a NFPA, treatment will be started at least 3 months after neurosurgery. In this case, the drug efficacy will be evaluated by MRI six months after pasireotide.~Pasireotide: The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
746775|NCT01620086|B3|Baseline|Total|Total of all reporting groups
746776|NCT01620086|B2|Baseline|Controls|These subjects are normal controls without schizophrenia who get stimulation over the vertex.
746777|NCT01620086|B1|Baseline|Patients|Patients with Schizophrenia who meet entry criteria for the study and get stimulation over temporal cortex.
746778|NCT01620086|P3|Participant Flow|Patients: Baseline, Control Site, 10Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz over the control site at the vertex, and then were randomized to receive 10 Hz over the treatment site in temporal cortex before receiving 1 Hz over the treatment site in temporal cortex. All treatment is for four days.
746779|NCT01620086|P2|Participant Flow|Patients: Baseline, Control Site, & 1Hz First|These are schizophrenic patients who meet entry criteria for the study. Patients in this arm receive baseline testing, then control site stimulation at 1Hz or 10 Hz located over the control site at the vertex, and then were randomized to receive 1 Hz over the treatment site in temporal cortex before receiving 10 Hz over the treatment site in temporal cortex. All stimulation is delivered for four days.
746780|NCT01620086|P1|Participant Flow|Controls: Baseline, 1Hz Sham, 1 Hz Active Over Vertex|These subjects are normal controls without schizophrenia who receive baseline testing, then sham rTMS, and then active 1Hz rTMS. All stimulation is for two days and delivered over the control site located at the vertex.
746781|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746782|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746783|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746784|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
746785|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
746842|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
746843|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
754257|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg|9/9.6 μg
746786|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746787|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746788|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746789|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
746790|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
746791|NCT01620086|O5|Outcome|Patients: Active 10 Hz Treatment Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746792|NCT01620086|O4|Outcome|Patients: Active 1Hz Treatment Site - Baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746793|NCT01620086|O3|Outcome|Patients: Control Site-baseline|"Patients with Schizophrenia who meet entry criteria for the study. Baseline, no stimulation~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 1 Hz~Repetitive Transcranial Magnetic Stimulation over temporal cortex at 10 Hz~Control site Repetitive Transcranial Magnetic Stimulation over the vertex at 1 or 10 Hz"
746794|NCT01620086|O2|Outcome|Controls: Sham Contorl Site rTMS - Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
746795|NCT01620086|O1|Outcome|Controls: 1Hz Control Site Active-Baseline|"These subjects are normal controls without schizophrenia.~Baseline, no stimulation~Active Repetitive Transcranial Magnetic Stimulation 1 Hz over vertex~Sham Repetitive Transcranial Magnetic Stimulation at 1Hz over vertex"
746796|NCT01620086|E2|Reported Event|Controls|These subjects are normal controls without schizophrenia.
746797|NCT01620086|E1|Reported Event|Patients|These are schizophrenic patients who meet entry criteria for the study.
746798|NCT01620060|B1|Baseline|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
746799|NCT01620060|P1|Participant Flow|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
746800|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
746801|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
746802|NCT01620060|O1|Outcome|Lurasidone Oral Tablets|"Lurasidone 20, 40, 80, 120 or 160 mg/day~Lurasidone: Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days"
746805|NCT01620047|B3|Baseline|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746806|NCT01620047|B2|Baseline|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746807|NCT01620047|B1|Baseline|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746808|NCT01620047|P3|Participant Flow|Intravenous Fentanyl|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746809|NCT01620047|P2|Participant Flow|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746810|NCT01620047|P1|Participant Flow|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746876|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
750001|NCT01605877|O1|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
746811|NCT01620047|O3|Outcome|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746812|NCT01620047|O2|Outcome|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746813|NCT01620047|O1|Outcome|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746814|NCT01620047|E3|Reported Event|Intravenous Fentanyl With Placebo|Control group which received 0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746815|NCT01620047|E2|Reported Event|Femoral Nerve Ropivacaine|Ropivacaine 0.1% continuously delivered through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746816|NCT01620047|E1|Reported Event|Femoral Nerve Fentanyl|Fentanyl 3 µg/ml delivered continuously through a femoral nerve sheath catheter for 24 hours post-total knee replacement. All study drugs were continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
746817|NCT01619878|B1|Baseline|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746818|NCT01619878|P1|Participant Flow|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746819|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746820|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746821|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746822|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746823|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746824|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746825|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746826|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746827|NCT01619878|O1|Outcome|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746828|NCT01619878|E1|Reported Event|Cohort 1|"One Artemether-lumefantrine (COA566) dispersible tablet taken orally twice a day during 3 days.~Infants age >28 days."
746829|NCT01619800|B3|Baseline|Total|Total of all reporting groups
746830|NCT01619800|B2|Baseline|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
746831|NCT01619800|B1|Baseline|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
746832|NCT01619800|P2|Participant Flow|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
748375|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
746833|NCT01619800|P1|Participant Flow|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
746834|NCT01619800|O2|Outcome|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
746835|NCT01619800|O1|Outcome|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
746836|NCT01619800|E2|Reported Event|Accelerometer Alone (AA)|Patients in this arm will undergo pacemaker implantation but will not have Minute Ventilation Sensor activated. Only accelerometer will remain active
746837|NCT01619800|E1|Reported Event|Blended Sensor Optimization (BSO)|Patients in this arm will undergo pacemaker placement and will have blended sensor optimization. Minute Ventilation will be optimized/activated
746838|NCT01619787|B3|Baseline|Total|Total of all reporting groups
746839|NCT01619787|B2|Baseline|Overweight/Obese Participants|"Participants whose baseline BMI is greater than or equal to 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
746840|NCT01619787|B1|Baseline|Lean Participants|"Participants whose baseline BMI is less than 25.~All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study; therefore, 5 participants were lost to follow up and no age or body mass index are reported for these participants."
746844|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
746845|NCT01619787|O3|Outcome|Overweight/Obese Participants|Participants with BMI greater than or equal to 25.
746846|NCT01619787|O2|Outcome|Lean Participants|Participants with BMI less than 25.
746847|NCT01619787|O1|Outcome|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
746848|NCT01619787|E1|Reported Event|Online Grocery|All participants completed a baseline session where behavioral measures of delay discounting, relative reinforcing value and relative reinforcing efficacy, along with the Three Factor Eating Questionnaire were measured. Participants then completed five shopping sessions under various price conditions. Age and Body Mass Index were measured at the end of the six session study.
746849|NCT01619774|B1|Baseline|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
746850|NCT01619774|P1|Participant Flow|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
746851|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
746852|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
746853|NCT01619774|O1|Outcome|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
746854|NCT01619774|E1|Reported Event|GSK2118436 + GSK1120212|GSK1120212 2 mg by mouth once a day, and GSK2118436 150 mg by mouth 2 times every day (1 time in the morning and 1 time in the evening, about 12 hours apart).
746855|NCT01619579|B3|Baseline|Total|Total of all reporting groups
746856|NCT01619579|B2|Baseline|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
746857|NCT01619579|B1|Baseline|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
746858|NCT01619579|P2|Participant Flow|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily.
746859|NCT01619579|P1|Participant Flow|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily.
746860|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
746861|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
746862|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
746983|NCT01618708|E2|Reported Event|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
746863|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
746864|NCT01619579|O2|Outcome|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
746865|NCT01619579|O1|Outcome|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
746866|NCT01619579|E2|Reported Event|Treatment Group B|Treatment Group B (n=17) underwent two AVACEN Treatment Method (ATM) warming sessions for 15 minutes daily. The participants completed the warming treatment sessions at home.
746867|NCT01619579|E1|Reported Event|Treatment Group A|Treatment Group A (n=5) underwent one AVACEN Treatment Method (ATM) warming session for 10 minutes daily. The participants completed the warming treatment sessions at home.
746868|NCT01619059|B3|Baseline|Total|Total of all reporting groups
746869|NCT01619059|B2|Baseline|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746870|NCT01619059|B1|Baseline|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746871|NCT01619059|P2|Participant Flow|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746872|NCT01619059|P1|Participant Flow|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746873|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746874|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746875|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746920|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746877|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746878|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746879|NCT01619059|O2|Outcome|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746880|NCT01619059|O1|Outcome|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746881|NCT01619059|E2|Reported Event|Saxagliptin 5mg + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin 5mg, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746882|NCT01619059|E1|Reported Event|Placebo + Dapagliflozin 10mg + Metformin|Participants received Saxagliptin-matching placebo, dapagliflozin 10mg once daily plus open-label metformin for up to 52 weeks
746883|NCT01618968|B5|Baseline|Total|Total of all reporting groups
746884|NCT01618968|B4|Baseline|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746885|NCT01618968|B3|Baseline|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746886|NCT01618968|B2|Baseline|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746887|NCT01618968|B1|Baseline|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746888|NCT01618968|P4|Participant Flow|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746889|NCT01618968|P3|Participant Flow|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746890|NCT01618968|P2|Participant Flow|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746891|NCT01618968|P1|Participant Flow|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746892|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
746893|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
746894|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
746895|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
746896|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
746897|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
746898|NCT01618968|O3|Outcome|Treatment C|SC injection of Vibex MTX into the Thigh
746899|NCT01618968|O2|Outcome|Treatment B|SC injection of Vibex MTX into the Abdomen
746900|NCT01618968|O1|Outcome|Treatment A|Oral Methotrexate (MTX) Tablets
747197|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
746901|NCT01618968|E4|Reported Event|25mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746902|NCT01618968|E3|Reported Event|20mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746903|NCT01618968|E2|Reported Event|15mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746904|NCT01618968|E1|Reported Event|10mg MTX|[administered via randomized sequence and crossover of Treatment A - Oral Methotrexate (MTX) Tablets, Treatment B - SC injection of Vibex MTX into the Abdomen and Treatment C - SC injection of Vibex MTX into the Thigh]
746905|NCT01618955|B5|Baseline|Total|Total of all reporting groups
746906|NCT01618955|B4|Baseline|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746907|NCT01618955|B3|Baseline|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746908|NCT01618955|B2|Baseline|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746909|NCT01618955|B1|Baseline|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746910|NCT01618955|P4|Participant Flow|MTX 25 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746911|NCT01618955|P3|Participant Flow|MTX 20 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746912|NCT01618955|P2|Participant Flow|MTX 15 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746913|NCT01618955|P1|Participant Flow|MTX 10 mg|Self-administration of Subcutaneous Methotrexate using VIBEX MTX
746914|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746915|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746916|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746917|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746918|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746919|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746924|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746925|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746926|NCT01618955|O4|Outcome|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746927|NCT01618955|O3|Outcome|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746928|NCT01618955|O2|Outcome|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746929|NCT01618955|O1|Outcome|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746930|NCT01618955|E4|Reported Event|Vibex MTX 25 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746931|NCT01618955|E3|Reported Event|Vibex MTX 20 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746932|NCT01618955|E2|Reported Event|Vibex MTX 15 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746933|NCT01618955|E1|Reported Event|Vibex MTX 10 mg|Self-administration of subcutaneous methotrexate using Vibex MTX
746934|NCT01618942|B3|Baseline|Total|Total of all reporting groups
746935|NCT01618942|B2|Baseline|Female Subjects|grouped by gender
746936|NCT01618942|B1|Baseline|Male Subjects|grouped by gender
746937|NCT01618942|P2|Participant Flow|Female Subjects|grouped by gender grouped by gender and applied with hand-held pressure algometer with differen
746938|NCT01618942|P1|Participant Flow|Male Subjects|grouped by gender and applied with hand-held pressure algometer with differen
746939|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746940|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746941|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746942|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746943|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746944|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746945|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746946|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746947|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746948|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746949|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746950|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746951|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746952|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746953|NCT01618942|O2|Outcome|Female Subjects|grouped by gender
746954|NCT01618942|O1|Outcome|Male Subjects|grouped by gender
746955|NCT01618942|E2|Reported Event|Female Subjects|grouped by gender
746956|NCT01618942|E1|Reported Event|Male Subjects|grouped by gender
746957|NCT01618864|B1|Baseline|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
746958|NCT01618864|P1|Participant Flow|Luxe Treatment Group|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
746959|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Evaluation of rosacea after 8 weeks of treatment.
746960|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Subjects with rosacea were evaluated by the investigator and a score provided according to a validated rosacea scale for improvement in features of rosacea such as flushing.
746961|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks and assessment at week 8.
746962|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by assessment.
746963|NCT01618864|O2|Outcome|Luxe Treatment Group at 8 Weeks|GAI assessment by investigator at 8 weeks.
746964|NCT01618864|O1|Outcome|Luxe Treatment Group at 4 Weeks|Luxe: Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
746965|NCT01618864|E1|Reported Event|Treatment Group|All treated subjects were evaluated for adverse events during the study.
746966|NCT01618838|B1|Baseline|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
746967|NCT01618838|P1|Participant Flow|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
746995|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
750002|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
746968|NCT01618838|O1|Outcome|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
746969|NCT01618838|E1|Reported Event|CyberKnife Radiosurgery, Colonoscopy|"CyberKnife radiosurgery for prostate cancer; bowel toxicity will be evaluated at 2 years by colonoscopy (lower endoscopy).~CyberKnife radiosurgery: Treatment Planning:~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
746970|NCT01618708|B3|Baseline|Total|Total of all reporting groups
746971|NCT01618708|B2|Baseline|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
746972|NCT01618708|B1|Baseline|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
746973|NCT01618708|P2|Participant Flow|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
746974|NCT01618708|P1|Participant Flow|Placebo|Single 6 mL intraarticular (IA) injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
746975|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
746976|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
746977|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
746978|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
746979|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
746980|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One at Day 1. Participants were observed for 26 weeks in follow up period.
746981|NCT01618708|O2|Outcome|Synvisc-One|Single 6 mL IA injection of Synvisc-One (48 mg of Hylan G-F 20 polymer) at Day 1. Participants were observed for 26 weeks in follow up period.
746982|NCT01618708|O1|Outcome|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
746984|NCT01618708|E1|Reported Event|Placebo|Single 6 mL IA injection of placebo matched to Synvisc-One (phosphate buffered saline) at Day 1. Participants were observed for 26 weeks in follow up period.
746985|NCT01618669|B3|Baseline|Total|Total of all reporting groups
746986|NCT01618669|B2|Baseline|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746987|NCT01618669|B1|Baseline|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746988|NCT01618669|P2|Participant Flow|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746989|NCT01618669|P1|Participant Flow|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT myocardial perfusion imaging (MPI). One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746990|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746991|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746992|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746993|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746994|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746996|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746997|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746998|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
746999|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747000|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747001|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747002|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747003|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747004|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747005|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747006|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747007|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747008|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747128|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747009|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747010|NCT01618669|O6|Outcome|REG Alone: MPI 2 SDS ≥ 14|Participants in the Regadenoson (REG) Alone group who had an SDS ≥ 14 on their second stress scan.
747011|NCT01618669|O5|Outcome|REG Alone: MPI 2 SDS 7-13|Participants in the Regadenoson (REG) Alone group who had an SDS from 7 to 13 on their second stress scan.
747012|NCT01618669|O4|Outcome|REG Alone: MPI 2 SDS 0-6|Participants in the Regadenoson (REG) Alone group who had an SDS from 0 to 6 on their second stress scan.
747013|NCT01618669|O3|Outcome|REG APEX: MPI 2 SDS ≥ 14|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS ≥ 14 on their second stress scan.
747014|NCT01618669|O2|Outcome|REG APEX: MPI 2 7-13|Participants in the Regadenoson After Peak Exercise (REG APEX) group who had an SDS from 7 to 13 on their second stress scan.
747015|NCT01618669|O1|Outcome|REG APEX: MPI 2 SDS 0-6|Participants in the Regadenoson After Peak Exercise (APEX) group who had an SDS from 0 to 6 on their second stress scan.
747016|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747017|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747018|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747019|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747020|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747021|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747217|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747022|NCT01618669|O4|Outcome|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747023|NCT01618669|O3|Outcome|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747024|NCT01618669|O2|Outcome|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747025|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747026|NCT01618669|O2|Outcome|Regadenoson Alone|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747027|NCT01618669|O1|Outcome|Regadenoson After Peak Exercise|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747028|NCT01618669|E4|Reported Event|Regadenoson Alone: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747029|NCT01618669|E3|Reported Event|Regadenoson Alone: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, (1 hour after exercise recovery) and then stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747030|NCT01618669|E2|Reported Event|Regadenoson After Peak Exercise: MPI 2|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747031|NCT01618669|E1|Reported Event|Regadenoson After Peak Exercise: MPI 1|On Day 1 participants received regadenoson, 0.4 mg in a 5 mL intravenous bolus, 3 minutes after exercise while in walk recovery and then a stress SPECT MPI. One to 14 days later participants received regadenoson at rest and then a stress SPECT MPI.
747032|NCT01618422|B3|Baseline|Total|Total of all reporting groups
747033|NCT01618422|B2|Baseline|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
747034|NCT01618422|B1|Baseline|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin.
747035|NCT01618422|P2|Participant Flow|DOTS Plus|"The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.~Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and"
747036|NCT01618422|P1|Participant Flow|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
747037|NCT01618422|O2|Outcome|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
747038|NCT01618422|O1|Outcome|DOTS Strategy|The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
747140|NCT01617668|P4|Participant Flow|Paclitaxel Without LCL161 (Negative Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747218|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747219|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747039|NCT01618422|E2|Reported Event|DOTS Plus|Directly Observed Therapy (DOTS) plus: The DOTS-Plus strategy (the strategy to be tested) includes additional measures including continuous drug resistance surveillance, culture, drug susceptibility testing for TB patients, and tailoring of individual drug regimen through the use of first and second-line drugs. The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
747040|NCT01618422|E1|Reported Event|DOTS Strategy|The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin (2HRZE/4HR or 2HRZS/4HR). In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used (2HRZES/1HRZE/5HRE).
747041|NCT01618266|B1|Baseline|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747042|NCT01618266|P1|Participant Flow|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747043|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747044|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747045|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747046|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747047|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747048|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747049|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747050|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747051|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747052|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747053|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747054|NCT01618266|O1|Outcome|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747055|NCT01618266|E1|Reported Event|Ozurdex® (Dexamethasone Intravitreal Implant)|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
747056|NCT01618240|B1|Baseline|Baseline Population|Thirty long-term ventilated patients admitted in two intensive care units at Massachusetts General Hospital.
747057|NCT01618240|P1|Participant Flow|Long-term Ventilated Subjects|Long-term (>10 days hours) ventilated subjects were included.
747198|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747058|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
747059|NCT01618240|O1|Outcome|Muscle Strength Measurement|Muscle Strength Measurement : MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
747060|NCT01618240|E1|Reported Event|Long-term Ventilated Subjects|30 consented long-term ventilated patients
747061|NCT01618227|B3|Baseline|Total|Total of all reporting groups
747062|NCT01618227|B2|Baseline|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
747063|NCT01618227|B1|Baseline|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
747064|NCT01618227|P2|Participant Flow|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
747141|NCT01617668|P3|Participant Flow|Paclitaxel With LCL161 (Negative Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747220|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747065|NCT01618227|P1|Participant Flow|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
747066|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
747067|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
747068|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
747069|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
747070|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
747071|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
747072|NCT01618227|O2|Outcome|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
747073|NCT01618227|O1|Outcome|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
747074|NCT01618227|E2|Reported Event|Rehabilitation Without Splinting|Rehabilitation without splinting: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
747129|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747130|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
751697|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
747075|NCT01618227|E1|Reported Event|Rehabilitation With Static Progressive Splinting|"Static progressive splinting is a well-established adjunct for restoring motion in stiff joints. Such splints apply a static stress relaxation force to the wrist and forearm tissues, which is sequentially increased as motion is achieved.~Joint Active Systems (JAS) Static progressive splint: Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer."
747076|NCT01618214|B3|Baseline|Total|Total of all reporting groups
747077|NCT01618214|B2|Baseline|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747142|NCT01617668|P2|Participant Flow|Paclitaxel Without LCL161 (Positive Group)|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747143|NCT01617668|P1|Participant Flow|Paclitaxel With LCL161 (Positive Group)|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747078|NCT01618214|B1|Baseline|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747079|NCT01618214|P2|Participant Flow|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747080|NCT01618214|P1|Participant Flow|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747081|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747082|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747083|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747084|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747085|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747131|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747132|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747133|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747134|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747086|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747087|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747144|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
747088|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747089|NCT01618214|O2|Outcome|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747090|NCT01618214|O1|Outcome|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747091|NCT01618214|E2|Reported Event|Investigator-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were asked to adjust their BIAsp 30 doses according to the directions from investigators throughout the trial period [20 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747092|NCT01618214|E1|Reported Event|Subject-driven Titration|Subjects were transferred on a 1:1 basis from pre-trial premixed/self-mixed human insulin to biphasic insulin aspart 30 (BIAsp 30). Individually adjusted BIAsp 30 was given immediately before breakfast and dinner during 20 weeks. Subjects were trained on how to adjust BIAsp 30 doses during the training period [4 weeks] and then were asked to adjust their BIAsp 30 doses by themselves during the maintenance period [16 weeks]. Subjects continued their pre-trial oral anti-diabetic drugs (OADs) (metformin and/or alpha-glucosidase inhibitor). OADs were kept unchanged in regimen and daily dose during this trial, and were administered orally according to local labels.
747093|NCT01618162|B3|Baseline|Total|Total of all reporting groups
747094|NCT01618162|B2|Baseline|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747095|NCT01618162|B1|Baseline|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747096|NCT01618162|P2|Participant Flow|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747135|NCT01618019|E2|Reported Event|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747136|NCT01618019|E1|Reported Event|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747137|NCT01617668|B3|Baseline|Total|Total of all reporting groups
747097|NCT01618162|P1|Participant Flow|IDegLira|In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747145|NCT01617668|O1|Outcome|LCL161|Patients randomized to the LCL161 1800 mg once weekly for 12 weeks.
747146|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
754258|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
747098|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747099|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747100|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747101|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747102|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747103|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747104|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747105|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747106|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747107|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
754259|NCT01587079|O1|Outcome|GP MDI 18 μg (PT001)|18 μg
747108|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747109|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747110|NCT01618162|O2|Outcome|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747111|NCT01618162|O1|Outcome|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747112|NCT01618162|E2|Reported Event|Placebo|In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
747113|NCT01618162|E1|Reported Event|IDegLira|In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−6.0 mmol/L).
747114|NCT01618019|B3|Baseline|Total|Total of all reporting groups
747115|NCT01618019|B2|Baseline|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747116|NCT01618019|B1|Baseline|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747117|NCT01618019|P2|Participant Flow|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747118|NCT01618019|P1|Participant Flow|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747119|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747120|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747121|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747122|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747123|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747124|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747125|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747126|NCT01618019|O1|Outcome|N-3 PUFA|5 capsules/day of n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
747127|NCT01618019|O2|Outcome|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
747189|NCT01617655|O1|Outcome|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 78 weeks).
747138|NCT01617668|B2|Baseline|Paclitaxel Without LCL161|Patients randomized to the control arm received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747139|NCT01617668|B1|Baseline|Paclitaxel With LCL161|Patients randomized to the experimental arm received paclitaxel 80 mg/m2 weekly + LECL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747216|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747147|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747148|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747149|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747150|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747151|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747152|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747153|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747154|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747155|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747156|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747157|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747158|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747159|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747160|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
748376|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
747161|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747162|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747163|NCT01617668|O2|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
747164|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
747165|NCT01617668|O1|Outcome|Paclitaxel Only|Patients randomized to the control arm who received paclitaxel 80 mg/m2 weekly for 12 weeks.
747166|NCT01617668|O1|Outcome|LCL161 + Paclitaxel|Patients randomized to the experimental arm who received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks.
747167|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747168|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747169|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747170|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747171|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747172|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747173|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747174|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747175|NCT01617668|O4|Outcome|Paclitaxel Only (Gene Expression Signature Negative)|Patients randomized to the control arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747176|NCT01617668|O3|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Negative)|Patients randomized to the experimental arm for gene expression signature negative received paclitaxel 80 mg/m2 weekly + LCL161 1800 mg once weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747177|NCT01617668|O2|Outcome|Paclitaxel Only (Gene Expression Signature Positive)|Patients randomized to the control arm for gene expression signature positive received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747178|NCT01617668|O1|Outcome|LCL161 + Paclitaxel (Gene Expression Signature Positive)|Patients randomized to the experimental arm for gene expression signature positive received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747179|NCT01617668|E2|Reported Event|PACLITAXEL|Patients randomized to the control arm for gene expression signature positive/negative received paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747180|NCT01617668|E1|Reported Event|LCL161+PACLITAXEL|Patients randomized to the experimental arm for gene expression signature positive/negative received LCL161 1800 mg once weekly + paclitaxel 80 mg/m2 weekly for 12 weeks. Equal numbers of patients with gene expression signature positive and negative disease were included in each treatment arm.
747181|NCT01617655|B3|Baseline|Total|Total of all reporting groups
747182|NCT01617655|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747183|NCT01617655|B1|Baseline|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747184|NCT01617655|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747185|NCT01617655|P1|Participant Flow|Placebo Q2W|Placebo for alirocumab subcutaneous (SC) injection every two weeks (Q2W) on top of stable lipid-modifying therapy (LMT) for 78 weeks.
747186|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747187|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747188|NCT01617655|O2|Outcome|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 78 weeks).
753461|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
747199|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747200|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747201|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747202|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747203|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747204|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747205|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747206|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747207|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747208|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747209|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747210|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747211|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747212|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747213|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747214|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747215|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
754260|NCT01587079|E8|Reported Event|Spiriva|18 μg
747221|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747222|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747223|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747224|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747225|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747226|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747227|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747228|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747229|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747230|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747231|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747232|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747233|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747234|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747235|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747236|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747237|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747238|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747239|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747240|NCT01617655|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W on top of stable LMT for 78 weeks.
747241|NCT01617655|O1|Outcome|Placebo Q2W|Placebo for alirocumab SC injection Q2W on top of stable LMT for 78 weeks.
747242|NCT01617655|E2|Reported Event|Alirocumab 150 Q2W|Participants exposed to Alirocumab 150 mg Q2W on top of stable LMT (mean exposure of 68 weeks).
747243|NCT01617655|E1|Reported Event|Placebo Q2W|Participants exposed to placebo Q2W on top of stable LMT (mean exposure of 71 weeks).
747244|NCT01617603|B4|Baseline|Total|Total of all reporting groups
747245|NCT01617603|B3|Baseline|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747246|NCT01617603|B2|Baseline|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747247|NCT01617603|B1|Baseline|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747335|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747248|NCT01617603|P3|Participant Flow|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747249|NCT01617603|P2|Participant Flow|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747250|NCT01617603|P1|Participant Flow|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747251|NCT01617603|O3|Outcome|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747252|NCT01617603|O2|Outcome|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747253|NCT01617603|O1|Outcome|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747254|NCT01617603|E3|Reported Event|Nestle Noir 70 % Chocolate|"Nestle Noir 70 % chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747255|NCT01617603|E2|Reported Event|Low Polyphenol Milk|"Low polyphenol milk control (matched to product 1 as closely as possible for milk content, carbohydrate, fat and calories, made from cocoa butter, sugar, milk powder and small amount of cocoa liquor to improve taste, giving approximately 0.05mg/g epicatechin.~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747360|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747256|NCT01617603|E1|Reported Event|High Polyphenol Milk Chocolate|"High polyphenol milk chocolate containing approximately 1 mg/g of epicatechin~Cocoa Polyphenols : 20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given"
747257|NCT01617577|B3|Baseline|Total|Total of all reporting groups
747258|NCT01617577|B2|Baseline|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
747259|NCT01617577|B1|Baseline|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
747260|NCT01617577|P2|Participant Flow|Placebo First Phase|Subjects assigned to this arm receive placebo injections daily for 5 days; after wk 7 they crossover to receive 5 daily injections of injections of G-CSF.
747261|NCT01617577|P1|Participant Flow|G-CSF First Phase|Subjects assigned to this arm receive G-CSF for 5 days during the first phase of the study. At week 7 these subjects cross over to receive placebo injections for five days
747262|NCT01617577|O1|Outcome|G-CSF and Placebo|All participants received G-CSF and placebo in crossover order
747263|NCT01617577|O2|Outcome|Placebo|All participants received placebo either in the first or second phase of crossover
747264|NCT01617577|O1|Outcome|G-CSF|All participants received G-CSF either in the first or second phase of the crossover
747265|NCT01617577|E2|Reported Event|G-CSF|participants who received GCSF injecitons during first or second phase
747266|NCT01617577|E1|Reported Event|Placebo|subjects who received placebo in either phase of the study
747267|NCT01617447|B3|Baseline|Total|Total of all reporting groups
747268|NCT01617447|B2|Baseline|Placebo|Placebo were orally administered once daily for 8 weeks.
747269|NCT01617447|B1|Baseline|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
747270|NCT01617447|P2|Participant Flow|Placebo|Placebo were orally administered once daily for 8 weeks.
747271|NCT01617447|P1|Participant Flow|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
747272|NCT01617447|O2|Outcome|Placebo|Placebo were orally administered once daily for 8 weeks.
747273|NCT01617447|O1|Outcome|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
747274|NCT01617447|E2|Reported Event|Placebo|Placebo were orally administered once daily for 8 weeks.
747275|NCT01617447|E1|Reported Event|Aripiprazole|Aripiprazole were orally administered once daily for 8 weeks. The starting dose was 1 mg/day, and the dose will be escalated to 3, 6, 9, 12, and 15 mg/day in a stepwise manner. The dose was fixed after Week 6 and administration continued for another 2 weeks until Week 8.
747276|NCT01617434|B3|Baseline|Total|Total of all reporting groups
747277|NCT01617434|B2|Baseline|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747278|NCT01617434|B1|Baseline|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747279|NCT01617434|P2|Participant Flow|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747280|NCT01617434|P1|Participant Flow|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747281|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
750003|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
747282|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747283|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747284|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747285|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747286|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747287|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747336|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747337|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747338|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747288|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747289|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747290|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747291|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747292|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747293|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747294|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747295|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747296|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747297|NCT01617434|O2|Outcome|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747339|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747340|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747341|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747298|NCT01617434|O1|Outcome|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747299|NCT01617434|E2|Reported Event|Placebo|Placebo was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the placebo was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747300|NCT01617434|E1|Reported Event|Liraglutide|Liraglutide was administered subcutaneously (s.c. injection, under the skin) once daily (OD) for 26 weeks in combination with pre-trial basal insulin analogue regimen ± metformin. The starting dose of the liraglutide was 0.6 mg/day; dose was escalated to 1.2 mg/day after one week and 1.8 mg/day after 2 weeks; dose was maintained at 1.8 mg day for subsequent weeks until the end of the trial. All subjects continued their pre-trial insulin therapy of insulin glargine (100 U/mL, s.c. injection) or insulin detemir (100 U/mL, s.c. injection). Oral anti diabetic drug metformin was administered as a tablet with a total daily dose of ≥1500 mg, divided into one to three doses per day.
747301|NCT01617369|B1|Baseline|Hypertonic Saline|"2.8% NaCl~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
747302|NCT01617369|P1|Participant Flow|Hypertonic Saline|"2.8% NaCl~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
747303|NCT01617369|O2|Outcome|Sustained Hypertonic Saline Effect|"2.8% NaCl Inhaled 4 hours before mucociliary clearance measured~Hypertonic saline = 2.8% NaCl x 4 ml delivered via Pari LC STAR jet nebulizer"
747304|NCT01617369|O1|Outcome|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before MCC scan performed~Hypertonic Saline: 2.8% NaCl x 4ml via Pari LC STAR jet nebulizer"
747305|NCT01617369|E2|Reported Event|Sustained Hypertonic Saline Effect|"2.8% NaCl inhaled 4 hours before Mucociliary Clearance measured.~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
747306|NCT01617369|E1|Reported Event|Acute Hypertonic Saline Effect|"2.8% NaCl inhaled 30 minutes before Mucociliary Clearance measured.~Hypertonic Saline: 2.8% NaCl x 4ml via nebulizer"
747307|NCT01617187|B5|Baseline|Total|Total of all reporting groups
747308|NCT01617187|B4|Baseline|Placebo BID|Participants were administered placebo tablets BID for 42 days
747309|NCT01617187|B3|Baseline|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747310|NCT01617187|B2|Baseline|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747311|NCT01617187|B1|Baseline|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747312|NCT01617187|P4|Participant Flow|Placebo BID|Participants were administered placebo tablets BID for 42 days
747313|NCT01617187|P3|Participant Flow|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) once daily (QD) for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747314|NCT01617187|P2|Participant Flow|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747315|NCT01617187|P1|Participant Flow|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet twice daily (BID) for 42 days
747316|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747317|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747318|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747319|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747320|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747321|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747322|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747323|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747324|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747325|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747326|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747327|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747328|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747329|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747330|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747331|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747332|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747333|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747334|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747342|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747343|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747344|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747345|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747346|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747347|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747348|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747349|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747350|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747351|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747352|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747353|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747354|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747355|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747356|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747357|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747358|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747359|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747361|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747362|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747363|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747364|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747365|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747366|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747367|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747368|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747369|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747370|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747371|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747372|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747373|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747374|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747375|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747376|NCT01617187|O4|Outcome|Placebo BID|Participants were administered placebo tablets BID for 42 days
747377|NCT01617187|O3|Outcome|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747378|NCT01617187|O2|Outcome|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747379|NCT01617187|O1|Outcome|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747380|NCT01617187|E4|Reported Event|Placebo BID|Participants were administered placebo tablets BID for 42 days
747381|NCT01617187|E3|Reported Event|Olanzapine 15 mg QD|Participants were administered 15 mg olanzapine (as one 10 mg and one 5 mg tablet) QD for 42 days, except during Week 1 olanzapine 10 mg QD was administered
747382|NCT01617187|E2|Reported Event|Asenapine 5 mg BID|Participants were administered one 5 mg asenapine tablet BID for 42 days
747383|NCT01617187|E1|Reported Event|Asenapine 2.5 mg BID|Participants were administered one 2.5 mg asenapine tablet BID for 42 days
747384|NCT01617070|B1|Baseline|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747385|NCT01617070|P1|Participant Flow|All Study Participants|"LNAA, washout, Kuvan, and LNAA+Kuvan~One group of 10 subjects, each under 4 conditions (each phase is 4 weeks)~Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747386|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
754179|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
747388|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
747389|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747390|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747391|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
747392|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
747393|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747394|NCT01617070|O4|Outcome|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747395|NCT01617070|O3|Outcome|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
747396|NCT01617070|O2|Outcome|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
747397|NCT01617070|O1|Outcome|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747398|NCT01617070|E4|Reported Event|BH4 and LNAA|"Kuvan: Dosed at 20 mg/kg; PO; Phase 3, Phase 4~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747399|NCT01617070|E3|Reported Event|BH4 (Kuvan)|Kuvan (BH4): Dosed at 20 mg/kg; PO; Phase 3, Phase 4
747400|NCT01617070|E2|Reported Event|Washout|no Kuvan or LNAA or any medical food products. Limited protein intake diet.
747401|NCT01617070|E1|Reported Event|LNAA|"LNAA~Large Neutral Amino Acid Therapy: Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food"
747402|NCT01617005|B1|Baseline|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
747806|NCT01612702|E1|Reported Event|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
747403|NCT01617005|P1|Participant Flow|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active Rheumatoid Arthritis (RA) participants, receiving tocilizumab treatment according to effective official Summary of Product Characteristics (SPC), were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
747404|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
747405|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
747406|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
747407|NCT01617005|O1|Outcome|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
747408|NCT01617005|E1|Reported Event|Tocilizumab in Moderate to Severe Active RA|Moderate to severe active RA participants, receiving tocilizumab treatment according to effective official SPC, were observed. The choice of therapy was based exclusively on the medical decision of the treating physician before study enrollment. The study protocol did not enforce treatment initiation and also did not specify any treatment regimen.
747409|NCT01616953|B3|Baseline|Total|Total of all reporting groups
747410|NCT01616953|B2|Baseline|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
747411|NCT01616953|B1|Baseline|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
747412|NCT01616953|P2|Participant Flow|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
748377|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
747413|NCT01616953|P1|Participant Flow|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
747414|NCT01616953|O2|Outcome|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
747415|NCT01616953|O1|Outcome|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
747416|NCT01616953|O2|Outcome|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
747807|NCT01612676|B5|Baseline|Total|Total of all reporting groups
747417|NCT01616953|O1|Outcome|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
747418|NCT01616953|E2|Reported Event|Autogenous Bone Grafting|"Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.~Autogenous Bone Grafting: Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care."
747419|NCT01616953|E1|Reported Event|Ixmyelocel-T|"iliac bone marrow aspirates are expanded ex vivo to enrich for adult multipotent cells (ixmyelocel-T) capable of regenerating bone and blood vessels and reducing inflammation. Following cell expansion, autologous ixmyelocel-T is then packaged and can be used as an autologous graft for treatment of bone defects.~Ixmyelocel-T: Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)"
747420|NCT01616771|B1|Baseline|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
747421|NCT01616771|P1|Participant Flow|Glottis View Assessment|After checking the C&L grade using Macintosh laryngoscope, C&L grade was re-evaluated using GVL selected by weight and smaller sized GVL in consecutive order.
747422|NCT01616771|O2|Outcome|Smaller Sized GVL|The C&L grade was reassessed by smaller sized GVL, after removal of GVL selected by weight
747423|NCT01616771|O1|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
747424|NCT01616771|O2|Outcome|GVL Selected by Weight|Right after Macintosh laryngoscope was removed, C&L grade was reassessed by second laryngoscopy, using GVL selected by weight.
747425|NCT01616771|O1|Outcome|Macintosh Laryngoscope|After induction of anesthesia, Macintosh laryngoscope was inserted into mouth and C&L grade was checked.
747426|NCT01616771|E3|Reported Event|Smaller Sized GVL|C&L grade assessment by smaller sized GVL, after removal of GVL selected by weight
747427|NCT01616771|E2|Reported Event|GVL Selected by Weight|C&L grade assessment by GVL selected by weight, after removal of Macintosh laryngoscope
747428|NCT01616771|E1|Reported Event|Macintosh Laryngoscope|C&L grade assessment by Macintosh laryngoscope, after induction of anesthesia
747429|NCT01616576|B3|Baseline|Total|Total of all reporting groups
747430|NCT01616576|B2|Baseline|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
747431|NCT01616576|B1|Baseline|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
748211|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747432|NCT01616576|P2|Participant Flow|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
747433|NCT01616576|P1|Participant Flow|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
747434|NCT01616576|O2|Outcome|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
747435|NCT01616576|O1|Outcome|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System for the second week.~Control Sound Processing Strategy: HiRes Fidelity120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
747436|NCT01616576|O3|Outcome|Experimental|Data from Group A and Group B were pooled for the statistical analyses. Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B.
747437|NCT01616576|O2|Outcome|Control|Data from Group A and Group B were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B.
754261|NCT01587079|E7|Reported Event|FF MDI 9.6 μg (PT005)|9.6 μg
747438|NCT01616576|O1|Outcome|Group A and Group B Data Pooled|Data from Group A (n=18) and Group B (n=18) were pooled for the statistical analyses. Control data consists of Week 1 data from Group A and Week 2 data from Group B; Experimental data consisted of Week 2 data from Group A and Week 1 data from Group B. The resulting mean Control score was subtracted from the mean Experimental score to yield a paired difference score (i.e. Experimental - Control = paired difference score). The paired difference score (n=36) is reported below for each listening condition.
747439|NCT01616576|E2|Reported Event|Experimental First, Then Control (Group B)|"Initial subject use of Experimental Sound Processing Strategy for the first week for the HiResolution™ Bionic Ear System, followed by subject use of the Control Sound Processing Strategy for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
747440|NCT01616576|E1|Reported Event|Control First, Then Experimental (Group A)|"Initial subject use of Control Sound Processing Strategy for the first week, followed by subject use of Experimental Sound Processing Strategy for the HiResolution™ Bionic Ear System condition for the second week.~Control Sound Processing Strategy: HiRes Fidelity 120™ Sound Processing Strategy, which is currently marketed sound processing strategy.~Experimental Sound Processing Strategy: newly modified sound processing strategy for the HiResolution™ Bionic Ear System."
747441|NCT01616459|B5|Baseline|Total|Total of all reporting groups
747442|NCT01616459|B4|Baseline|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747443|NCT01616459|B3|Baseline|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747444|NCT01616459|B2|Baseline|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747558|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
754180|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
747445|NCT01616459|B1|Baseline|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747446|NCT01616459|P4|Participant Flow|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747447|NCT01616459|P3|Participant Flow|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747448|NCT01616459|P2|Participant Flow|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747449|NCT01616459|P1|Participant Flow|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747450|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747451|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747452|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747559|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
747586|NCT01615822|E2|Reported Event|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
748212|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747453|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747454|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747455|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747456|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747457|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747458|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747459|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747460|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747560|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
748213|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747461|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747462|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747463|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747464|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747465|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747466|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747467|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747468|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747561|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
747587|NCT01615822|E1|Reported Event|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
748214|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747469|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747470|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747471|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747472|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747473|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747474|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747475|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747476|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747562|NCT01615939|O2|Outcome|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
748215|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747477|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747478|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747479|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747480|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747481|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747482|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747483|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747484|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747563|NCT01615939|O1|Outcome|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
747603|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747485|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747486|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747487|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747488|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747489|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747490|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747491|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747492|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747564|NCT01615939|E2|Reported Event|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
748216|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747493|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747494|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747495|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747496|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747497|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747498|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747499|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747500|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747565|NCT01615939|E1|Reported Event|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
747566|NCT01615822|B4|Baseline|Total|Total of all reporting groups
747567|NCT01615822|B3|Baseline|Placebo|Placebo
747568|NCT01615822|B2|Baseline|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
747501|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747502|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747503|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747504|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747505|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747506|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747507|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747508|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747569|NCT01615822|B1|Baseline|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
747570|NCT01615822|P3|Participant Flow|Placebo|Placebo
747571|NCT01615822|P2|Participant Flow|Cohort 2|"Period 1: OZ439 400mg single dose oral suspension~Period 2: Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets"
747572|NCT01615822|P1|Participant Flow|Cohort 1|"Period 1: OZ439 100mg single dose oral suspension~Period 2: Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet"
747509|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747510|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747511|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747512|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747513|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747514|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747515|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747516|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747573|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
747574|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
747575|NCT01615822|O2|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets
747576|NCT01615822|O1|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet
754181|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
747517|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747518|NCT01616459|O2|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747519|NCT01616459|O1|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747520|NCT01616459|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747521|NCT01616459|O1|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747522|NCT01616459|O2|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747523|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747524|NCT01616459|O2|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747577|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets~OZ439 400mg: OZ439 400mg oral suspension, single dose~MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
747578|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension~OZ439 400mg: OZ439 400mg oral suspension, single dose"
747579|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet~OZ439 100mg: OZ439 100mg oral suspension, single dose~MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
747525|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The first 3 doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747526|NCT01616459|O4|Outcome|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747527|NCT01616459|O3|Outcome|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747528|NCT01616459|O2|Outcome|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747529|NCT01616459|O1|Outcome|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747530|NCT01616459|E4|Reported Event|Prevnar13 Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Prevnar13™ vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Prevnar13™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Prevnar13™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate ).
747531|NCT01616459|E3|Reported Event|Synflorix Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of Synflorix™ at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of Synflorix™ were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of Synflorix™ was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747532|NCT01616459|E2|Reported Event|12Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830930A, or 12Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 12Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 12Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747580|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension~OZ439 100mg: OZ439 100mg oral suspension, single dose"
747581|NCT01615822|O4|Outcome|OZ439 400mg Plus MQ 750mg Single Doses|"Single dose OZ439 400mg oral suspension in combination with single dose MQ 750mg tablets~OZ439 400mg: OZ439 400mg oral suspension, single dose~MQ 750mg, single dose: Mefloquine 750mg oral tablet, single dose"
747582|NCT01615822|O3|Outcome|OZ439 400mg Single Dose|"OZ439 400mg single dose oral suspension~OZ439 400mg: OZ439 400mg oral suspension, single dose"
748217|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747533|NCT01616459|E1|Reported Event|11Pn Group|Healthy male or female subjects between, and including 6 to 12 weeks (42-90 days) of age at the time of first vaccination, received a 3-dose primary vaccination course of GSK2830929A, or 11Pn, vaccine at 2, 3 and 4 months of age, followed by a booster dose of the same vaccine at 12-15 months of age, each dose being co-administered with one dose of Infanrix hexa™. The 3 first doses of 11Pn vaccine were administered intramuscularly into the right anterolateral thigh and Infanrix hexa™ was administered intramuscularly into the left anterolateral thigh. The booster dose of 11Pn vaccine was administered intramuscularly into the right deltoid (or thigh if the deltoid muscle size was not adequate) and that of Infanrix hexa™ was administered intramuscularly into the left deltoid (or thigh if the deltoid muscle size was not adequate).
747534|NCT01616173|B4|Baseline|Total|Total of all reporting groups
747535|NCT01616173|B3|Baseline|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
747536|NCT01616173|B2|Baseline|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
747537|NCT01616173|B1|Baseline|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
747538|NCT01616173|P3|Participant Flow|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
747539|NCT01616173|P2|Participant Flow|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
747540|NCT01616173|P1|Participant Flow|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
747541|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
747542|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
747543|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
747544|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
747545|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
747546|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
747547|NCT01616173|O3|Outcome|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
747548|NCT01616173|O2|Outcome|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
747549|NCT01616173|O1|Outcome|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
747550|NCT01616173|E3|Reported Event|No Perioperative Steroids|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and 50mL saline infusion
747551|NCT01616173|E2|Reported Event|Intravenous Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine with saline/2mL and IV dexamethsone 8mg in 50mL infusion
747552|NCT01616173|E1|Reported Event|Perineural Dexamethasone|Ultrasound guided sciatic nerve block with bupivicaine 0.5% with 1:300,000 epinephrine and perineural dexamethasone 8mg/2mL ,and 50mL IV normal saline infusion
747553|NCT01615939|B3|Baseline|Total|Total of all reporting groups
747554|NCT01615939|B2|Baseline|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
747555|NCT01615939|B1|Baseline|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
747556|NCT01615939|P2|Participant Flow|Continuous Sciatic Nerve Block|"Continuous sciatic nerve block catheters will be performed using an insulated needle connected to the negative lead of a constant current nerve stimulator. The catheter will be advanced under ultrasound guidance. A test dose of 1.5% lidocaine with epinephrine will be injected to confirm catheter placement. All subjects will receive a portable pump that will infuse 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr. The subjects will follow standard protocol discharge instructions in regards to removing the catheter themselves.~Ropivacaine: 0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr."
747557|NCT01615939|P1|Participant Flow|Single Shot Sciatic Nerve Block|"Single shot sciatic nerve blocks will be performed by resident trainees supervised by faculty. Bupivacaine 0.625% with epinephrine 1:300,000 will be injected incrementally in 3-ml aliquots to a total volume of 0.4 ml/kg (minimum, 20 ml; maximum, 35 ml).~Bupivacaine: Bupivacaine 0.625% with epinephrine 1:300,000"
747583|NCT01615822|O2|Outcome|OZ439 100mg Plus MQ 250mg Single Doses|"Single dose OZ439 100mg oral suspension in combination with single dose MQ 250mg tablet~OZ439 100mg: OZ439 100mg oral suspension, single dose~MQ 250 mg, single dose: Mefloquine 250 mg tablet, single dose"
747584|NCT01615822|O1|Outcome|OZ439 100mg Single Dose|"OZ439 100mg single dose oral suspension~OZ439 100mg: OZ439 100mg oral suspension, single dose"
747585|NCT01615822|E3|Reported Event|Placebo|Placebo
747588|NCT01615809|B1|Baseline|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization was 10 ml (50 mg) twice a week for the first week, and then from the second week onwards was reduced to 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count demonstrated to be greater than or equal to 1500 cells/mm3."
747589|NCT01615809|P1|Participant Flow|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
747590|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
747641|NCT01615263|E2|Reported Event|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9F, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
755530|NCT01581021|B3|Baseline|Total|Total of all reporting groups
747591|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
747592|NCT01615809|O1|Outcome|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
747593|NCT01615809|E1|Reported Event|Amphotericin B (ABELCET®)|"Patients fulfilling inclusion criteria and those giving the general informed consent for the study will initiate nebulized Amphotericin B prophylaxis treatment, twice a week, during neutropenia periods (coincident with intensive chemotherapy treatment).~﻿AMPHOTERICIN B: The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.The administration regimen for each Abelcet® nebulization will be 10 ml (50 mg) twice a week for the first week, and then from the second week onwards it will be 5 ml (25 mg) with a minimum separation of 72 hours between doses, until the neutrophil count is greater than or equal to 1500 cells/mm3."
747594|NCT01615731|B3|Baseline|Total|Total of all reporting groups
747595|NCT01615731|B2|Baseline|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747596|NCT01615731|B1|Baseline|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747597|NCT01615731|P2|Participant Flow|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747598|NCT01615731|P1|Participant Flow|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747599|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747600|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747601|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747602|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
748218|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
747604|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747605|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747606|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747607|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747608|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747642|NCT01615263|E1|Reported Event|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
747643|NCT01615198|B3|Baseline|Total|Total of all reporting groups
747609|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747610|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747611|NCT01615731|O2|Outcome|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747612|NCT01615731|O1|Outcome|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747613|NCT01615731|E2|Reported Event|Mifepristone Plus One Set of Dilators|"One set of dilators plus mifepristone~Mifepristone: 200mg Mifepristone orally~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747614|NCT01615731|E1|Reported Event|Two Sets of Dilators|"Two sets of osmotic dilators inserted 1 and 2 days pre-op~Hygroscopic cervical dilators: Dilapan-S osmostic cervical dilators inserted through the internal os~Misoprostol: 400mcg buccal misoprostol 90 minutes pre-op~Intra-amniotic digoxin: 1mg digoxin administered intra-amniotically ~24 hours pre-op"
747615|NCT01615328|B3|Baseline|Total|Total of all reporting groups
747616|NCT01615328|B2|Baseline|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
747617|NCT01615328|B1|Baseline|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
747618|NCT01615328|P2|Participant Flow|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
747619|NCT01615328|P1|Participant Flow|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
747620|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be caried out with Bonion after randomization procedure."
747621|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be caried out with Cervios ChronOs after randomization procedure."
747622|NCT01615328|O2|Outcome|Bonion|"The ACDF surgery will be carried out with Bonion(TM), which is the PEEK cage with HA/DBM.~Bonion: The ACDF surgery will be carried out with Bonion after randomization procedure."
747623|NCT01615328|O1|Outcome|Cervios ChronOs|"The ACDF surgery will be carried out with Cervios ChronOs(TM), which is the PEEK cage filled with b-TCP.~Cervios ChronOs: The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure."
747624|NCT01615328|O2|Outcome|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
747625|NCT01615328|O1|Outcome|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
747626|NCT01615328|E2|Reported Event|Bonion|The patients underwent ACDF using Bonion which is the PEEK cage with Hydroxyapatite and demineralized bone matrix.
747627|NCT01615328|E1|Reported Event|Cervios ChronOS|The patients underwent ACDF using Cervios ChronOS(TM) which is the PEEK cage filled with b-TCP.
747628|NCT01615263|B3|Baseline|Total|Total of all reporting groups
747629|NCT01615263|B2|Baseline|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
747630|NCT01615263|B1|Baseline|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
747631|NCT01615263|P2|Participant Flow|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
747632|NCT01615263|P1|Participant Flow|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Ireland.)
748363|NCT01611883|B1|Baseline|Ezetimibe|10 mg oral dose once daily for 24 weeks
747633|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
747634|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
747635|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
747636|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
747637|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
747638|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
747639|NCT01615263|O2|Outcome|Bronchial Blocker|Lung isolation with a bronchial blocker with the inner channel closed (Fuji Uniblocker 9 Fr, Fuji System Corporation, Tokyo, 113-0033, Japan) inserted via a 8.0 mm simple lumen endotracheal tube.
747640|NCT01615263|O1|Outcome|Double Lumen Tube|Lung isolation with a left double lumen tube (BronchoCath, Mallinckrodt Medical, Cornamaddy, Athlone, Westmeath, Ireland.)
750004|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
747644|NCT01615198|B2|Baseline|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747645|NCT01615198|B1|Baseline|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747646|NCT01615198|P2|Participant Flow|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747647|NCT01615198|P1|Participant Flow|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747648|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747649|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747650|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747651|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747652|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747653|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747654|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747933|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747655|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747656|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747657|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747658|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747793|NCT01614509|E1|Reported Event|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
747794|NCT01612702|B3|Baseline|Total|Total of all reporting groups
747795|NCT01612702|B2|Baseline|Control|No dexamethasone
747659|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747660|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747661|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747662|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747663|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747664|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747665|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747666|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747667|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747668|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747669|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747670|NCT01615198|O2|Outcome|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747934|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747671|NCT01615198|O1|Outcome|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747672|NCT01615198|E2|Reported Event|Olmesartan|Participants were treated with olmesartan 10 mg qd for 4 weeks along with 2 placebo of LCZ696 tablets qd. Participants were then uptitrated to olmesartan 20 mg qd for 6 weeks along with 2 placebo of LCZ696 tablets qd. Participants, who did not achieve their goal BP, were uptitrated to olmesartan 40 mg qd for the remaining 4 weeks and 2 placebo LCZ696 tablets qd.
747673|NCT01615198|E1|Reported Event|LCZ696|Participants were treated with one LCZ696 100 mg tablet and one placebo of LCZ696 every day (qd) for 4 weeks along with placebo of Olmesartan 10 mg capsule qd. Participants were then up-titrated to LCZ 200 mg tablet and one placebo of LCZ696 qd for 6 weeks along with placebo of Olmesartan 20 mg capsule qd. Participants, who did not achieve their goal BP, were uptitrated to 2 LCZ696 200 mg tablets (LCZ696 400 mg) qd for 4 weeks along with placebo of Olmesartan 40 mg capsule qd.
747674|NCT01615029|B6|Baseline|Total|Total of all reporting groups
747796|NCT01612702|B1|Baseline|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
747797|NCT01612702|P2|Participant Flow|Control|No dexamethasone
755988|NCT01579305|E2|Reported Event|Subjects Treated With Restylane-L®|
747675|NCT01615029|B5|Baseline|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747676|NCT01615029|B4|Baseline|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747677|NCT01615029|B3|Baseline|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747678|NCT01615029|B2|Baseline|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747679|NCT01615029|B1|Baseline|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747680|NCT01615029|P5|Participant Flow|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747681|NCT01615029|P4|Participant Flow|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747682|NCT01615029|P3|Participant Flow|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747683|NCT01615029|P2|Participant Flow|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747684|NCT01615029|P1|Participant Flow|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747685|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747822|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747686|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747687|NCT01615029|O4|Outcome|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747688|NCT01615029|O3|Outcome|Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747689|NCT01615029|O2|Outcome|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747690|NCT01615029|O1|Outcome|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747691|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747692|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747693|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747694|NCT01615029|O1|Outcome|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747695|NCT01615029|O4|Outcome|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747696|NCT01615029|O3|Outcome|Phase 1: 8 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747697|NCT01615029|O2|Outcome|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747698|NCT01615029|O1|Outcome|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747699|NCT01615029|E5|Reported Event|Phase 2: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747823|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747824|NCT01612676|O1|Outcome|Full Analysis Set|The full analysis data set (FAS) comprised data from all dosed patients.
747700|NCT01615029|E4|Reported Event|Phase 1: 16 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 16 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747701|NCT01615029|E3|Reported Event|Phase 1: 8mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 8 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747798|NCT01612702|P1|Participant Flow|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
747799|NCT01612702|O2|Outcome|Control|No dexamethasone
747800|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
747801|NCT01612702|O2|Outcome|Control|No dexamethasone
747702|NCT01615029|E2|Reported Event|Phase 1: 4 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 4 mg/kg on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747703|NCT01615029|E1|Reported Event|Phase 1: 2 mg/kg Daratumumab + Lenalidomide and Dexamethasone|Participants administered with daratumumab 2 milligram/kilogram (mg/kg) on Day 0 (pre dose infusion), 1, 8, 15, 22 (cycle 1), Days 1, 8, 15, and 22 (cycle 2), Days 1 and 15 (Cycles 3 to 6), Day 1 (Cycle 7+) along with Lenalidomide 25 milligram (mg) on Day 1 to 21 of each 28-day cycle and Dexamethasone 40 mg (weekly) and may be reduced to 20 mg (weekly after cycle 6 at the investigator’s discretion). Each treatment cycle consists of 28 days.
747704|NCT01614886|B3|Baseline|Total|Total of all reporting groups
747705|NCT01614886|B2|Baseline|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
747706|NCT01614886|B1|Baseline|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
747707|NCT01614886|P2|Participant Flow|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
747708|NCT01614886|P1|Participant Flow|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
747709|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
747710|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
747711|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
747712|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
747713|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
747714|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
747715|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
747716|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
747717|NCT01614886|O2|Outcome|Rivastigmine Patch 3 Step|3-step titration group begins treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
747718|NCT01614886|O1|Outcome|Rivastigmine Patch 1 Step|1-step titration group begins treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day
747719|NCT01614886|E2|Reported Event|Rivastigmine Patch 3-step|Rivastigmine patch 3-step
747720|NCT01614886|E1|Reported Event|Rivastigmine Patch 1-step|Rivastigmine patch 1-step
747721|NCT01614795|B5|Baseline|Total|Total of all reporting groups
747722|NCT01614795|B4|Baseline|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747723|NCT01614795|B3|Baseline|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747904|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747905|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747906|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747907|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747724|NCT01614795|B2|Baseline|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747802|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
747803|NCT01612702|O2|Outcome|Control|No dexamethasone
747804|NCT01612702|O1|Outcome|Dexamethasone|dexamethasone 10 mg administration 1 hour before surgery
747805|NCT01612702|E2|Reported Event|Control|No dexamethasone
747725|NCT01614795|B1|Baseline|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747726|NCT01614795|P4|Participant Flow|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747727|NCT01614795|P3|Participant Flow|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747728|NCT01614795|P2|Participant Flow|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747729|NCT01614795|P1|Participant Flow|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747730|NCT01614795|O4|Outcome|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747731|NCT01614795|O3|Outcome|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747732|NCT01614795|O2|Outcome|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747733|NCT01614795|O1|Outcome|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747734|NCT01614795|E4|Reported Event|Group 4 Relapsed or Refractory Non-rhabdo Soft Tissue Sarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747735|NCT01614795|E3|Reported Event|Group 3 Relapsed or Refractory Rhabdomyosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
754182|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
747792|NCT01614509|E2|Reported Event|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
755989|NCT01579305|E1|Reported Event|Subjects Treated With VOLBELLA®|
747736|NCT01614795|E2|Reported Event|Group 2 Relapsed or Refractory Ewing Sarcoma/Peripheral PNET|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747737|NCT01614795|E1|Reported Event|Group 1 Relapsed or Refractory Osteosarcoma|"Patients receive cixutumumab IV over 1 hour and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 25 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV, Days 1, 8, 15, and 22, dosage 6 mg/kg. Cixutumumab dose is based on weight (kg).~temsirolimus: Given IV, Days 1, 8, 15, and 22 8 mg/m2 (maximum dose = 16 mg) (Cycle 1), Dose escalation to 10 mg/m2 (maximum dose = 20 mg). Temsirolimus dose is based on BSA.~laboratory biomarker analysis: Correlative studies"
747738|NCT01614769|B1|Baseline|All Participants|All randomized participants
747739|NCT01614769|P6|Participant Flow|Glimepiride 4 mg → Glimepiride 2 mg → Placebo|Participants received 4 mg glimepiride in the first period, 2 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
747740|NCT01614769|P5|Participant Flow|Glimepiride 2 mg → Placebo → Glimepiride 4 mg|Participants received 2 mg glimepiride in the first period, placebo in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
747741|NCT01614769|P4|Participant Flow|Placebo → Glimepiride 4 mg → Glimepiride 2 mg|Participants received placebo in the first period, 4 mg glimepiride in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
747742|NCT01614769|P3|Participant Flow|Glimepiride 4 mg → Placebo → Glimepiride 2 mg|Participants received 4 mg glimepiride in the first period, placebo in the second period and 2 mg glimepiride in the third period, with a 7-day washout between each period.
747743|NCT01614769|P2|Participant Flow|Glimepiride 2 mg → Glimepiride 4 mg → Placebo|Participants received 2 mg glimepiride in the first period, 4 mg glimepiride in the second period and placebo in the third period, with a 7-day washout between each period.
747744|NCT01614769|P1|Participant Flow|Placebo → Glimepiride 2 mg → Glimepiride 4 mg|Participants received placebo in the first period, 2 mg glimepiride in the second period and 4 mg glimepiride in the third period, with a 7-day washout between each period.
747745|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
747746|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
747747|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
747748|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
747749|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
747750|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
747751|NCT01614769|O3|Outcome|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
747752|NCT01614769|O2|Outcome|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
747753|NCT01614769|O1|Outcome|Placebo|Participants received placebo in a treatment period.
747754|NCT01614769|E3|Reported Event|Glimepiride 4 mg|Participants received 4 mg Glimepiride in a treatment period.
747755|NCT01614769|E2|Reported Event|Glimepiride 2 mg|Participants received 2 mg Glimepiride in a treatment period.
747756|NCT01614769|E1|Reported Event|Placebo|Participants received placebo in a treatment period.
747757|NCT01614613|B1|Baseline|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
747758|NCT01614613|P1|Participant Flow|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal:safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips.
747759|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
747760|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
747761|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
747908|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
754183|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
747762|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
747763|NCT01614613|O1|Outcome|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips
747764|NCT01614613|E1|Reported Event|Intended BGM Users|Subjects were assigned to subgroups according to their initial glucose levels. Subgroup 1 goal:safely decrease subject glucose levels during the visit. Subgroup 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems.
747765|NCT01614600|B1|Baseline|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
747766|NCT01614600|P1|Participant Flow|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
747767|NCT01614600|O1|Outcome|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
747768|NCT01614600|E1|Reported Event|DAILIES® AquaComfort Plus®|Nelfilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for 2 weeks
747769|NCT01614574|B1|Baseline|VPRIV® (15-60 U/kg)|
747770|NCT01614574|P1|Participant Flow|VPRIV® (15-60 U/kg)|
747771|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747772|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747773|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747774|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747775|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747776|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747777|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747778|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747779|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747780|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747781|NCT01614574|O1|Outcome|VPRIV® (15-60 U/kg)|
747782|NCT01614574|E1|Reported Event|VPRIV® (15-60 U/kg)|
747783|NCT01614509|B3|Baseline|Total|Total of all reporting groups
747784|NCT01614509|B2|Baseline|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
747785|NCT01614509|B1|Baseline|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
747786|NCT01614509|P2|Participant Flow|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
747787|NCT01614509|P1|Participant Flow|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
747788|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
747789|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
747790|NCT01614509|O2|Outcome|Combined Group|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The Bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
747791|NCT01614509|O1|Outcome|Monotherapy Group|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
747909|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747910|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747911|NCT01614457|E2|Reported Event|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747808|NCT01612676|B4|Baseline|Infusion Regimen 4|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747809|NCT01612676|B3|Baseline|Infusion Regimen 3|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747810|NCT01612676|B2|Baseline|Infusion Regimen 2|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747811|NCT01612676|B1|Baseline|Infusion Regimen 1|FE 202158 0.1 mg/ml (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747812|NCT01612676|P4|Participant Flow|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747813|NCT01612676|P3|Participant Flow|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747814|NCT01612676|P2|Participant Flow|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747815|NCT01612676|P1|Participant Flow|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747816|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747817|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747818|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747819|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747820|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747821|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747825|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747826|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747827|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747828|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747829|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747830|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747831|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747832|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747833|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747834|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747835|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747836|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747837|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747838|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747839|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747840|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747841|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747842|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747843|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747844|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747912|NCT01614457|E1|Reported Event|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747845|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747846|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747847|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747848|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747849|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747850|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747851|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747852|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747853|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747854|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747855|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747856|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747857|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747858|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747859|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747860|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747861|NCT01612676|O4|Outcome|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747862|NCT01612676|O3|Outcome|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747863|NCT01612676|O2|Outcome|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747864|NCT01612676|O1|Outcome|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747865|NCT01612676|E5|Reported Event|Total|Summation of adverse events in all treatment arms
747866|NCT01612676|E4|Reported Event|Infusion Regimen 4: Modified 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min, allowed to be increased to a maximum of 7.5 ng/kg/min if needed, with a maximum duration of 1 hour, during the first 6 hours of infusion. After 1 hour, or beyond the initial 6 hours, the infusion rate could not exceed 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747867|NCT01612676|E3|Reported Event|Infusion Regimen 3: 7.5 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5-3.75 ng/kg/min adjustable up to a maximum of 7.5 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747868|NCT01612676|E2|Reported Event|Infusion Regimen 2: 5.0 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 5.0 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747869|NCT01612676|E1|Reported Event|Infusion Regimen 1: 3.75 ng/kg/Min|FE 202158 0.1 mg/mL (10 mM acetate buffer, pH 4) was administered at initial infusion rate of 2.5 ng/kg/min, adjustable up to 3.75 ng/kg/min. Each patient received FE 202158 until recovered from the shock, however for not more than 7 days.
747870|NCT01614470|B3|Baseline|Total|Total of all reporting groups
747871|NCT01614470|B2|Baseline|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
747872|NCT01614470|B1|Baseline|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
747873|NCT01614470|P3|Participant Flow|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
747874|NCT01614470|P2|Participant Flow|Part 1: Placebo First, Then Ivacaftor|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
747875|NCT01614470|P1|Participant Flow|Part 1: Ivacaftor First, Then Placebo|Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period.
747876|NCT01614470|O1|Outcome|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
747877|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747878|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747879|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
747880|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747881|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747882|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
747883|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
747884|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747885|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747886|NCT01614470|O1|Outcome|Part 1 Treatment Period 2: Ivacaftor, Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 24 weeks (8 weeks in Part 1: Treatment Period 2 and 16 weeks in Part 2).
747887|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747888|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747889|NCT01614470|O2|Outcome|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747890|NCT01614470|O1|Outcome|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747891|NCT01614470|E3|Reported Event|Part 2: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
747892|NCT01614470|E2|Reported Event|Part 1: Placebo|Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747893|NCT01614470|E1|Reported Event|Part 1: Ivacaftor|Ivacaftor 150 mg tablet orally twice daily for 8 weeks in either treatment period 1 or treatment period 2.
747894|NCT01614457|B3|Baseline|Total|Total of all reporting groups
747895|NCT01614457|B2|Baseline|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747896|NCT01614457|B1|Baseline|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747897|NCT01614457|P2|Participant Flow|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747898|NCT01614457|P1|Participant Flow|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747899|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747900|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747901|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747902|NCT01614457|O1|Outcome|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
747903|NCT01614457|O2|Outcome|Placebo|Placebo matched to ivacaftor tablet orally twice daily for 24 weeks.
747914|NCT01614249|B2|Baseline|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the intervention group, participants received a dietary supplement of Omega Via fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits to resupply the soft-gels, monitoring of side effects and compliance and data collection.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Each participants took three soft gels of fish oil omega-3 fatty acid per day, each containing more EPA (0.715 grams) than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
747915|NCT01614249|B1|Baseline|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
747943|NCT01613599|E1|Reported Event|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years
747944|NCT01613417|B3|Baseline|Total|Total of all reporting groups
747945|NCT01613417|B2|Baseline|Gadovist/Gadavist Then ProHance|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
750005|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
747916|NCT01614249|P2|Participant Flow|Fish Oil Omega-3 EPA-rich Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
747917|NCT01614249|P1|Participant Flow|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
747918|NCT01614249|O2|Outcome|Fish Oil Omega-3 EPA-rich Soft Gels Experimental Group|"As the experimental group, participants received dietary supplement of OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight weeks with bi-weekly follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing fish oil omega-3 EPA-rich soft gels to take for two weeks before returning for re-supply. Three soft gels of fish oil omega-3 fatty acid were taken by each participant per day. Each soft gel contained more eicosapentaenoic acid (EPA) of 0.715 grams than docosahexaenoic acid (DHA) of 0.340 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
747919|NCT01614249|O1|Outcome|Soybean Oil Soft Gels Control Group|"As a control group, participants received OmegaVia soybean oil soft gels for eight weeks with regular cell-phone and bi-weekly face-to-face follow-up visits. During each follow-up visit, participants were re-supplied with soft-gels and monitored for side effects and compliance.~Each participant randomly received a sequentially numbered, securely sealed opaque plastic bottle containing soybean oil soft gels to take for two weeks before returning for re-supply. Three soft gels of soybean oil were taken by each participant per day. Each soft gel contained saturated fatty acids (0.178 grams), monounsaturated fatty acids (0.299 grams) and polyunsaturated fatty acids (0.985 grams) with traces of eicosapentaenoic acid (EPA), of 0.115 grams. The soft gels were taken orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
747920|NCT01614249|E2|Reported Event|Fish Oil Omega-3 EPA-rich Soft Gels|"Participants received OmegaVia fish oil omega-3 EPA-rich soft gels to take orally for eight (8) weeks with bi-weekly follow-up visits for monitoring of side effects and compliance and data collection.~Fish oil omega-3 EPA-rich soft gels: A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels was taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits."
747921|NCT01614249|E1|Reported Event|Soybean Oil Soft Gels|"Participants on this arm received a dietary supplement of OmegaVia soybean oil soft gels as a placebo for 8 weeks with bi-weekly follow-up visits to monitor side effects and compliance.~Soybean oil soft gels: Each participant received OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks."
747922|NCT01612494|B3|Baseline|Total|Total of all reporting groups
747923|NCT01612494|B2|Baseline|Hypertonic Saline|
747924|NCT01612494|B1|Baseline|Normal Saline|
747925|NCT01612494|P2|Participant Flow|Hypertonic Saline|
747926|NCT01612494|P1|Participant Flow|Normal Saline|
747927|NCT01612494|O2|Outcome|Hypertonic Saline|
747928|NCT01612494|O1|Outcome|Normal Saline|
747929|NCT01612494|E2|Reported Event|Hypertonic Saline|
747930|NCT01612494|E1|Reported Event|Normal Saline|
747931|NCT01613599|B1|Baseline|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747932|NCT01613599|P1|Participant Flow|Rituximab|Participants with granulomatosis with polyangiitis (GPA) (Wegener’s granulomatosis) or microscopic polyangiitis (MPA) who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747935|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747936|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747937|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747938|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747939|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747940|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747941|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener's granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747942|NCT01613599|O1|Outcome|Rituximab|Participants with GPA (Wegener’s granulomatosis) or MPA who received rituximab as per investigator's discretion were followed for a maximum of 4 years.
747946|NCT01613417|B1|Baseline|ProHance Then Gadovist/Gadavist|Per Protocol=patients who completed both exams, had global paired image data available, and had no major protocol violations
747947|NCT01613417|P2|Participant Flow|Sequence 2 (Gadovist/Gadavist Then ProHance)|Patients randomized to receive Gadovist/Gadavist first
747948|NCT01613417|P1|Participant Flow|Sequence 1 (ProHance Then Gadovist/Gadavist)|Patients randomized to receive ProHance first
747949|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
747950|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
747951|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
747952|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
747953|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
747954|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
747955|NCT01613417|O6|Outcome|Reader 3 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
747956|NCT01613417|O5|Outcome|Reader 3 - ProHance|MRI after ProHance 0.1 mmol/kg
747957|NCT01613417|O4|Outcome|Reader 2 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
747958|NCT01613417|O3|Outcome|Reader 2 - ProHance|MRI after ProHance 0.1 mmol/kg
747959|NCT01613417|O2|Outcome|Reader 1 - Gadovist/Gadavist|MRI after Gadovist/Gadavist 0.1 mmol/kg
747960|NCT01613417|O1|Outcome|Reader 1 - ProHance|MRI after ProHance 0.1 mmol/kg
747961|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
747962|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
747963|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
747964|NCT01613417|O3|Outcome|Reader 3|Lesions reviewed by Reader 3
747965|NCT01613417|O2|Outcome|Reader 2|Lesions reviewed by Reader 2
747966|NCT01613417|O1|Outcome|Reader 1|Lesions reviewed by Reader 1
747967|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
747968|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
747969|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
747970|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
747971|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
747972|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
747973|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
747974|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
747975|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
747976|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
747977|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
747978|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
747979|NCT01613417|O3|Outcome|Reader 3|Paired exams reviewed by Reader 3
747980|NCT01613417|O2|Outcome|Reader 2|Paired exams reviewed by Reader 2
747981|NCT01613417|O1|Outcome|Reader 1|Paired exams reviewed by Reader 1
747982|NCT01613417|E2|Reported Event|Safety Population (Gadovist/Gadavist)|All enrolled patients who received a randomized injection of Gadovist/Gadavist
747983|NCT01613417|E1|Reported Event|Safety Population (ProHance)|All enrolled patients who received a randomized injection of ProHance
747984|NCT01613378|B1|Baseline|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747985|NCT01613378|P1|Participant Flow|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747986|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747987|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
748364|NCT01611883|P2|Participant Flow|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
747988|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747989|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747990|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747991|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747992|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747993|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747994|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
748782|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
747995|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747996|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747997|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747998|NCT01613378|O1|Outcome|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
747999|NCT01613378|E1|Reported Event|Rheumatoid Arthritis Cohort|"The cohort included participants with moderate to severe rheumatoid arthritis (RA) in whom the treating physician made the decision to initiate tocilizumab treatment.~No intervention: No intervention administered in this study"
748000|NCT01613339|B3|Baseline|Total|Total of all reporting groups
748001|NCT01613339|B2|Baseline|Control|No specific treatment.
748002|NCT01613339|B1|Baseline|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
748003|NCT01613339|P2|Participant Flow|Control|No specific treatment.
748004|NCT01613339|P1|Participant Flow|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
748005|NCT01613339|O2|Outcome|Control|No specific treatment.
748006|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
748007|NCT01613339|O2|Outcome|Control|No specific treatment.
748008|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
748009|NCT01613339|O2|Outcome|Control|No specific treatment.
748010|NCT01613339|O1|Outcome|Body Awareness Therapy|Balance training using Body awareness therapy : Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Exemple of exercies are weight-balancing in standing and relaxation exercises.
748011|NCT01613339|E1|Reported Event|Body Awareness Therapy, Control|group training. Controls were asked to continue with their lifestyle.
748012|NCT01613326|B3|Baseline|Total|Total of all reporting groups
748013|NCT01613326|B2|Baseline|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748014|NCT01613326|B1|Baseline|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748015|NCT01613326|P2|Participant Flow|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748016|NCT01613326|P1|Participant Flow|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748017|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748018|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748019|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748020|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748021|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748022|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748023|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748024|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748025|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748026|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748027|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748028|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748029|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748030|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748783|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748031|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748032|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748033|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748034|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748035|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748036|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748037|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748038|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748039|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748040|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748041|NCT01613326|O2|Outcome|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748042|NCT01613326|O1|Outcome|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748043|NCT01613326|E2|Reported Event|Tiotropium|Tiotropium 18 μg once a day and placebo to NVA237 once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748044|NCT01613326|E1|Reported Event|NVA237|NVA237 50 μg once a day and placebo to tiotropium once a day during 85 days. Salbutamol/albuterol was provided as rescue medication.
748045|NCT01613313|B5|Baseline|Total|Total of all reporting groups
748046|NCT01613313|B4|Baseline|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748047|NCT01613313|B3|Baseline|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748048|NCT01613313|B2|Baseline|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748049|NCT01613313|B1|Baseline|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748050|NCT01613313|P4|Participant Flow|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748051|NCT01613313|P3|Participant Flow|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748052|NCT01613313|P2|Participant Flow|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748053|NCT01613313|P1|Participant Flow|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748054|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748086|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748055|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748056|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748057|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748058|NCT01613313|O4|Outcome|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748059|NCT01613313|O3|Outcome|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748060|NCT01613313|O2|Outcome|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748094|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748061|NCT01613313|O1|Outcome|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748062|NCT01613313|E4|Reported Event|Dose #4|"single injection 0.44 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748063|NCT01613313|E3|Reported Event|Dose #3|"single injection 0.29 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748064|NCT01613313|E2|Reported Event|Dose #2|"single injection 0.15 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748065|NCT01613313|E1|Reported Event|Dose #1|"single injection 0.058 mg Collagenase Clostridium Histolyticum~Collagenase Clostridium Histolyticum: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg."
748066|NCT01613248|B7|Baseline|Total|Total of all reporting groups
748067|NCT01613248|B6|Baseline|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748068|NCT01613248|B5|Baseline|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748069|NCT01613248|B4|Baseline|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748070|NCT01613248|B3|Baseline|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748071|NCT01613248|B2|Baseline|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748072|NCT01613248|B1|Baseline|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748073|NCT01613248|P6|Participant Flow|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748074|NCT01613248|P5|Participant Flow|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748075|NCT01613248|P4|Participant Flow|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748076|NCT01613248|P3|Participant Flow|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748077|NCT01613248|P2|Participant Flow|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748078|NCT01613248|P1|Participant Flow|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748079|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748080|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748081|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748082|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748083|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748084|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748085|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
754184|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
748087|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748088|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748089|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748090|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748091|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748092|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748093|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748230|NCT01613014|O2|Outcome|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
748095|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748096|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748097|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748098|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748099|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748100|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748101|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748102|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748103|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748104|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748105|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748106|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748107|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748108|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748109|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748110|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748111|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748112|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748113|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748114|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748115|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748116|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748117|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748118|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748119|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748120|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748121|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748122|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748123|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748124|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748125|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748126|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748127|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748128|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748129|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748130|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748131|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748132|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748133|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748134|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748135|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748136|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748137|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748138|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748139|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748140|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748141|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748142|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748143|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748144|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748145|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748146|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748147|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748148|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748149|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748150|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748151|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748152|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748153|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748154|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
754185|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
748155|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748156|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748157|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748158|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748159|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748160|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748161|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748162|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748163|NCT01613248|O6|Outcome|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748164|NCT01613248|O5|Outcome|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748165|NCT01613248|O4|Outcome|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748166|NCT01613248|O3|Outcome|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748167|NCT01613248|O2|Outcome|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748168|NCT01613248|O1|Outcome|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748169|NCT01613248|E6|Reported Event|MK-1602 100 mg|MK-1602 100 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748170|NCT01613248|E5|Reported Event|MK-1602 50 mg|MK-1602 50 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748171|NCT01613248|E4|Reported Event|MK-1602 25 mg|MK-1602 25 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748172|NCT01613248|E3|Reported Event|MK-1602 10 mg|MK-1602 10 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748173|NCT01613248|E2|Reported Event|MK-1602 1 mg|MK-1602 1 mg single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748174|NCT01613248|E1|Reported Event|Placebo|Placebo-matching MK-1602 single dose as treatment for a moderate or severe migraine headache. After 2 hours participants were able to take rescue medication if necessary.
748175|NCT01613131|B3|Baseline|Total|Total of all reporting groups
748176|NCT01613131|B2|Baseline|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748177|NCT01613131|B1|Baseline|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748178|NCT01613131|P2|Participant Flow|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748179|NCT01613131|P1|Participant Flow|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748180|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748181|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748182|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748183|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748184|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
754186|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
748185|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748186|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748187|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748188|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748189|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748784|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748190|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748191|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748192|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748193|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748194|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748195|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748196|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748197|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748198|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748199|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748200|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748201|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748202|NCT01613131|O2|Outcome|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748203|NCT01613131|O1|Outcome|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748204|NCT01613131|E2|Reported Event|Mirena + Placebo Gel|"Subjects will be assigned to use of placebo gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Placebo Gel: Topical Gel, Applied once daily for 50 days, Placebo comparator."
748205|NCT01613131|E1|Reported Event|Mirena + Estradiol Gel|"Subjects will be assigned to use of Estradiol gel for use with Mirena.~Mirena: Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).~Estradiol: Topical, .06%, Applied once daily for 50 days."
748206|NCT01613027|B1|Baseline|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748207|NCT01613027|P1|Participant Flow|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748208|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748209|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748210|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748219|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748220|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748221|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748222|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748223|NCT01613027|O1|Outcome|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748224|NCT01613027|E1|Reported Event|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
748225|NCT01613014|B3|Baseline|Total|Total of all reporting groups
748226|NCT01613014|B2|Baseline|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
748227|NCT01613014|B1|Baseline|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
748228|NCT01613014|P2|Participant Flow|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
748229|NCT01613014|P1|Participant Flow|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
755990|NCT01579084|B11|Baseline|Total|Total of all reporting groups
748231|NCT01613014|O1|Outcome|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
748232|NCT01613014|E2|Reported Event|ABT-436|"ABT-436 Target dose of 400 mg BID~ABT-436: Target dose - 400mg BID"
748233|NCT01613014|E1|Reported Event|Sugar Pill|"Matched Placebo sugar pill - target dose 2 pills BID~Matched Placebo - Sugar Pill: Target Dose - 2 pills BID"
748234|NCT01612858|B3|Baseline|Total|Total of all reporting groups
748235|NCT01612858|B2|Baseline|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
748236|NCT01612858|B1|Baseline|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
748237|NCT01612858|P2|Participant Flow|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
748238|NCT01612858|P1|Participant Flow|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
748239|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
748240|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
748241|NCT01612858|O2|Outcome|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
748242|NCT01612858|O1|Outcome|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
748243|NCT01612858|E2|Reported Event|Pioglitazone|Pioglitazone: Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
748244|NCT01612858|E1|Reported Event|Metformin|Metformin: Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
748245|NCT01612767|B1|Baseline|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
748246|NCT01612767|P1|Participant Flow|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
748247|NCT01612767|O4|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748248|NCT01612767|O3|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748249|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - Discharge|PRO-Kinetic Energy Stent: Coronary artery stent implant
748250|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - Baseline|PRO-Kinetic Energy Stent: Coronary artery stent implant
748251|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
748252|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
748253|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
748254|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748255|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748256|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748257|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748258|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748259|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748260|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748261|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748262|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748263|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748264|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748265|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748266|NCT01612767|O2|Outcome|PRO-Kinetic Energy Stent - 9 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748267|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
754187|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
748268|NCT01612767|O1|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748269|NCT01612767|O1|Outcome|PRO-Kinetic Energy Stent - 1 Month|PRO-Kinetic Energy Stent: Coronary artery stent implant
748270|NCT01612767|O1|Outcome|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
748271|NCT01612767|E1|Reported Event|Pro-Kinetic Energy Stent|PRO-Kinetic Energy Stent: Coronary artery stent implant
748272|NCT01612156|B3|Baseline|Total|Total of all reporting groups
748273|NCT01612156|B2|Baseline|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
748274|NCT01612156|B1|Baseline|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
748300|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748275|NCT01612156|P2|Participant Flow|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
748276|NCT01612156|P1|Participant Flow|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
748277|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
748278|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
748279|NCT01612156|O2|Outcome|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
748280|NCT01612156|O1|Outcome|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
748281|NCT01612156|E2|Reported Event|Water Based Lubricant|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared wtih water based lubricant before use in the pelvic floor examination.~Water based lubricant: Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination."
748282|NCT01612156|E1|Reported Event|2% Lidocaine Gel|"Subjects in this arm will have all urethral catheters and urethral cotton tipped swabs prepared with 2% lidocaine gel before use in the examination.~2% lidocaine gel: 2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination."
748283|NCT01612000|B5|Baseline|Total|Total of all reporting groups
748284|NCT01612000|B4|Baseline|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748285|NCT01612000|B3|Baseline|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
748286|NCT01612000|B2|Baseline|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748287|NCT01612000|B1|Baseline|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748288|NCT01612000|P4|Participant Flow|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748289|NCT01612000|P3|Participant Flow|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
748290|NCT01612000|P2|Participant Flow|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748291|NCT01612000|P1|Participant Flow|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748292|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748293|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
748294|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748365|NCT01611883|P1|Participant Flow|Ezetimibe|10 mg oral dose once daily for 24 weeks
748295|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748296|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748297|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
748298|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748299|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748301|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
748302|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748303|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748304|NCT01612000|O4|Outcome|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748305|NCT01612000|O3|Outcome|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
748306|NCT01612000|O2|Outcome|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748307|NCT01612000|O1|Outcome|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748308|NCT01612000|E4|Reported Event|PanBlok 7.5µg in 2% SE|"7.5µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748309|NCT01612000|E3|Reported Event|PanBlok 7.5µg No Adjuvant|"7.5µg recombinant hemagglutinin, no adjuvant. 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection"
748310|NCT01612000|E2|Reported Event|PanBlok 3.8µg in 2% SE|"3.8µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748311|NCT01612000|E1|Reported Event|PanBlok 15µg in 2% SE|"15µg recombinant hemagglutinin in a 2% oil-in-water stable emulsion (rHA adjuvant). 0.5mL intramuscular injection on Day 0 and Day 21 in the deltoid muscle~PanBlok: Intramuscular injection~rHA adjuvant: Intramuscular injection"
748312|NCT01611974|B4|Baseline|Total|Total of all reporting groups
748313|NCT01611974|B3|Baseline|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748314|NCT01611974|B2|Baseline|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748315|NCT01611974|B1|Baseline|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748316|NCT01611974|P3|Participant Flow|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748317|NCT01611974|P2|Participant Flow|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748318|NCT01611974|P1|Participant Flow|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748319|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748320|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748321|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748322|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748323|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748324|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748366|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
748325|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748326|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748327|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748328|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748329|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748330|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748331|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748719|NCT01610076|O1|Outcome|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
748332|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748333|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748334|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748335|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748336|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748337|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748338|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748339|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748340|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748341|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748342|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748343|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748344|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748345|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748346|NCT01611974|O3|Outcome|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748347|NCT01611974|O2|Outcome|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748348|NCT01611974|O1|Outcome|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748349|NCT01611974|E3|Reported Event|Maribavir 1200 mg Twice Daily|Participants received oral maribavir at 1200 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748350|NCT01611974|E2|Reported Event|Maribavir 800 mg Twice Daily|Participants received oral maribavir at 800 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748351|NCT01611974|E1|Reported Event|Maribavir 400 mg Twice Daily|Participants received oral maribavir at 400 mg twice daily for a maximum duration of 24 weeks. Participants were then followed for 12 weeks.
748352|NCT01611948|B3|Baseline|Total|Total of all reporting groups
748353|NCT01611948|B2|Baseline|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748354|NCT01611948|B1|Baseline|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748355|NCT01611948|P2|Participant Flow|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748356|NCT01611948|P1|Participant Flow|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748357|NCT01611948|O2|Outcome|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748358|NCT01611948|O1|Outcome|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748359|NCT01611948|E2|Reported Event|Matched Placebo|Matched Placebo daily for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748360|NCT01611948|E1|Reported Event|Aprepitant: 125mg/Day|125mg/d aprepitant for 8 weeks given in conjunction with 8 weeks of manual-guided behavioral counseling.
748361|NCT01611883|B3|Baseline|Total|Total of all reporting groups
748362|NCT01611883|B2|Baseline|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
754188|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
748378|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
748379|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
748380|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
748381|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
748382|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
748383|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
748384|NCT01611883|O2|Outcome|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
748385|NCT01611883|O1|Outcome|Ezetimibe|10 mg oral dose once daily for 24 weeks
748386|NCT01611883|E2|Reported Event|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks
748387|NCT01611883|E1|Reported Event|Ezetimibe|10 mg oral dose once daily for 24 weeks
748388|NCT01611857|B3|Baseline|Total|Total of all reporting groups
748443|NCT01611558|O1|Outcome|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
748389|NCT01611857|B2|Baseline|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
748390|NCT01611857|B1|Baseline|Tivantinib+FOLFOX Dose Escalation|"Tivantinib: (120 mg, 240 mg, or 360 mg) orally, twice daily on Days 1-14 of each 2 week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
748391|NCT01611857|P2|Participant Flow|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle.~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle."
748392|NCT01611857|P1|Participant Flow|Tivantinib + FOLFOX Dose Escalation|"Tivantinib: (120 mg; 240 mg; or 360 mg) orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle;~FOLFOX: [5-Fluorouracil (5-FU) 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2] on Day 1 each cycle."
748393|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
748394|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
748395|NCT01611857|O1|Outcome|Tivantinib + FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 14-day cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 14-day cycle.~Treatment continued until disease progression or unacceptable toxicity."
748396|NCT01611857|O3|Outcome|Tivantinib 360 mg (PO BID) + FOLFOX|"Tivantinib 360 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
748397|NCT01611857|O2|Outcome|Tivantinib 240 mg (PO BID) + FOLFOX|"Tivantinib 240 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
748398|NCT01611857|O1|Outcome|Tivantinib 120 mg (PO BID) + FOLFOX|"Tivantinib 120 mg given orally, twice daily (PO BID) on Days 1-14 of each 14-day cycle;~FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle."
748399|NCT01611857|E2|Reported Event|Tivantinib+FOLFOX Dose Expansion|"Tivantinib: 360 mg PO BID on Days 1-14 of each 2-week cycle. FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 of each 2-week cycle.~Treatment continued until disease progression or unacceptable toxicity."
748400|NCT01611857|E1|Reported Event|Tivantinib+FOLFOX Dose Escalation|Tivantinib: orally, twice daily (PO BID) on Days 1-14 of each 2 week cycle; FOLFOX: (5-FU 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2) on Day 1 each cycle.
748401|NCT01611779|B1|Baseline|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748402|NCT01611779|P1|Participant Flow|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748403|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748404|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748405|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748406|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748407|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748408|NCT01611779|O1|Outcome|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748409|NCT01611779|E1|Reported Event|Tongue Suspension|"Tongue-based suspension~Encore Tongue Suspension System: The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw."
748438|NCT01611571|E1|Reported Event|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748410|NCT01611662|B1|Baseline|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
748411|NCT01611662|P1|Participant Flow|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
748412|NCT01611662|O1|Outcome|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
748413|NCT01611662|E1|Reported Event|Treatment (Gemcitabine Hydrochloride, Cisplatin, Surgery)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on day 1 and cisplatin IV on day 1 or divided over days 1 and 2. Treatment repeats every 14 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning 3-8 weeks after chemotherapy, patients undergo radical cystectomy.~gemcitabine hydrochloride: Given IV~cisplatin: Given IV~therapeutic conventional surgery: Undergo radical cystectomy~laboratory biomarker analysis: Correlative studies"
748414|NCT01611571|B4|Baseline|Total|Total of all reporting groups
748415|NCT01611571|B3|Baseline|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748416|NCT01611571|B2|Baseline|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748417|NCT01611571|B1|Baseline|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748418|NCT01611571|P3|Participant Flow|Placebo Risedronate + Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748419|NCT01611571|P2|Participant Flow|Active Risedronte + Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748420|NCT01611571|P1|Participant Flow|Active Risedronate + Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748421|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748422|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748423|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748424|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748425|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748426|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748427|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748428|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748429|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748430|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748431|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748432|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748433|NCT01611571|O3|Outcome|Placebo Risedronate Active Teriparatide|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748434|NCT01611571|O2|Outcome|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748435|NCT01611571|O1|Outcome|Active Risedronate Active Teriparatide|"Active Risedronate Active Teriparatide~Risedronic acid & teriparatide : weekly risedronate daily teriparatide"
748436|NCT01611571|E3|Reported Event|Placebo Risedronate Active Teriparatide, Active Risedronate|"Placebo Risedronate Active Teriparatide for 18 months Active Risedronate for 6 months~Teriparatide : weekly risedronate (placebo) 18 months daily teriparatide 18 months weekly risedronate 6 months"
748437|NCT01611571|E2|Reported Event|Active Risedronte Placebo Teriparatide|"Active Risedronte Placebo Teriparatide~Risedronic acid : weekly risedronate daily teriparatide (placebo)"
748439|NCT01611558|B1|Baseline|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
748440|NCT01611558|P1|Participant Flow|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
748441|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
748442|NCT01611558|O1|Outcome|Ipilimumab,10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
748444|NCT01611558|E1|Reported Event|Ipilimumab, 10 mg/kg|Participants received 10 mg/kg of ipilimumab administered intravenously once every 3 weeks for 4 doses (Induction Phase). Then, once every 12 weeks (Maintenance Phase), until disease progression or unacceptable toxicity occurs.
748445|NCT01610791|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748446|NCT01610791|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg), intravenously (IV), once every 4 weeks for a total of 6 infusions.
748447|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748448|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748449|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748450|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748451|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748452|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748453|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748454|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748455|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748456|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748457|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748458|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748459|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748460|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748461|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748462|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748463|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748464|NCT01610791|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748465|NCT01610791|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg, IV, once every 4 weeks for a total of 6 infusions.
748466|NCT01610713|B3|Baseline|Total|Total of all reporting groups
748467|NCT01610713|B2|Baseline|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748468|NCT01610713|B1|Baseline|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748469|NCT01610713|P2|Participant Flow|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748470|NCT01610713|P1|Participant Flow|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748547|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748548|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748471|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748472|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748473|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748474|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748475|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748476|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748477|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748478|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748479|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748480|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748481|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748482|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748483|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748484|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748485|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748486|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748659|NCT01610453|O1|Outcome|Transabdominal Ultrasound|Fetal head position was assessed using a transabdominal scan
748487|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748488|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748489|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748490|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748491|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748492|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748493|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748494|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748495|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748496|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748497|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748498|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748499|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748500|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748501|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748502|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748660|NCT01610453|O1|Outcome|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
748503|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748504|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748505|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748506|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748507|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748508|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748509|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748510|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748511|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748512|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748513|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748514|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748515|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748516|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748517|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748518|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748662|NCT01610297|B1|Baseline|ICL670|Oral dose of ICL670 at 10 mg/kg daily
748519|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748520|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748521|NCT01610713|O2|Outcome|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748522|NCT01610713|O1|Outcome|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748523|NCT01610713|E2|Reported Event|Placebo DB/GW-1000-02 OL|Participants receiving placebo in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748524|NCT01610713|E1|Reported Event|GW-1000-02 DB/OL|Participants receiving GW-1000-02 in the double-blind portion of the study (Part A - NCT01610700) and continuing on GW-1000-02 in this open-label portion of the study (Part B). GW-1000-02 contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748525|NCT01610700|B3|Baseline|Total|Total of all reporting groups
748526|NCT01610700|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748527|NCT01610700|B1|Baseline|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748528|NCT01610700|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748529|NCT01610700|P1|Participant Flow|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748530|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748531|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748532|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748533|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748534|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748535|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748536|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748537|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748538|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748539|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748540|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748541|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748542|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748543|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748544|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748545|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748546|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748549|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748550|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748551|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748552|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748553|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748554|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
756927|NCT01575197|B4|Baseline|Total|Total of all reporting groups
748555|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748556|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748557|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748558|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748559|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748560|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748561|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748562|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748563|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748564|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748565|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748566|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748567|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748568|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748569|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748570|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748571|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748572|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748573|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748574|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748575|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748576|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748577|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748578|NCT01610700|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748579|NCT01610700|O1|Outcome|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748580|NCT01610700|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
748581|NCT01610700|E1|Reported Event|GW-1000-02|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was284 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
748582|NCT01610687|B1|Baseline|GW-1000-02|Active treatment
748583|NCT01610687|P1|Participant Flow|GW-1000-02|GW-1000-02 contains Δ tetrahydrocannabinol, 27 mg/ml and cannabidiol, 25 mg/ml as extract of Cannabis sativa L. Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748584|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748585|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748586|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748587|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748588|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748589|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748590|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748591|NCT01610687|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748592|NCT01610687|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml). Subjects received study medication delivered in 100 μl actuations by a pump action oromucosal spray. Maximum permitted dose was eight actuations in any three hour period and 48 actuations (THC 130 mg:CBD 120 mg) in 24 hours
748593|NCT01610596|B3|Baseline|Total|Total of all reporting groups
748594|NCT01610596|B2|Baseline|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
748595|NCT01610596|B1|Baseline|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
748596|NCT01610596|P2|Participant Flow|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
748597|NCT01610596|P1|Participant Flow|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
748598|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
748599|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
748600|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
748601|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
748602|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
748603|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
748604|NCT01610596|O2|Outcome|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
748605|NCT01610596|O1|Outcome|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 1-2 weeks, not to exceed 50 grams per week"
748606|NCT01610596|E2|Reported Event|Vehicle Lotion|"Topical lotion, applied twice daily~Placebo"
748607|NCT01610596|E1|Reported Event|Halobetasol Propionate Lotion 0.05%|"Topical lotion, applied twice daily~Halobetasol Propionate Lotion 0.05%: Apply twice daily for 2 weeks, not to exceed 50 grams per week"
748608|NCT01610570|B5|Baseline|Total|Total of all reporting groups
748609|NCT01610570|B4|Baseline|Phase 2|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
748610|NCT01610570|B3|Baseline|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
748663|NCT01610297|P1|Participant Flow|ICL670|Oral dose of ICL670 at 10 mg/kg daily
748664|NCT01610297|O1|Outcome|ICL670|Oral dose of ICL670 at 10 mg/kg daily
748611|NCT01610570|B2|Baseline|Phase 1 Dose Level 1|Dose Escalation Phase 13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
748673|NCT01610167|B1|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748674|NCT01610167|P3|Participant Flow|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
758232|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
748612|NCT01610570|B1|Baseline|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously
748613|NCT01610570|P4|Participant Flow|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Mithramycin: Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously.
748614|NCT01610570|P3|Participant Flow|Phase 1 Dose Level 2|"Dose Escalation Phase~17.5 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
748615|NCT01610570|P2|Participant Flow|Phase 1 Dose Level 1|"Dose Escalation Phase~13.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
748616|NCT01610570|P1|Participant Flow|Phase I Dose Level -1|"Dose Escalation Phase~9.0 mcg/kg/dose Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously"
748617|NCT01610570|O4|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748618|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748653|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
748654|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
748655|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
748636|NCT01610557|P3|Participant Flow|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748778|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748619|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748620|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748621|NCT01610570|O1|Outcome|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748622|NCT01610570|O3|Outcome|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748623|NCT01610570|O2|Outcome|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748624|NCT01610570|O1|Outcome|Phase I Dose Level -1|Dose Escalation Ph 9.0 mcg/kg dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748625|NCT01610570|E4|Reported Event|Phase II - Expansion Phase|Expansion phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748656|NCT01610492|E1|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
748657|NCT01610453|B1|Baseline|Transperineal Ultrasound|Fetal head descent was assessed using a transperineal scan
748661|NCT01610453|E1|Reported Event|Transabdominal and Transperineal Sonography|Fetal head position was assessed using a transabdominal scan and fetal station was assessed by transperineal scan
748626|NCT01610570|E3|Reported Event|Phase I Dose Level 2|Dose Escalation Phase 17.5 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748627|NCT01610570|E2|Reported Event|Phase I Dose Level 1|Dose Escalation Phase 13.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748628|NCT01610570|E1|Reported Event|Phase I Dose Level -1|Dose Escalation Phase 9.0 mcg/kg.dose Ph I: Mithramycin will be administered in escalating doses to children and adolescents intravenously IV) over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Ph differs from the recommended adult dose for Ph II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered IV at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Ph II: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
748629|NCT01610557|B5|Baseline|Total|Total of all reporting groups
748630|NCT01610557|B4|Baseline|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748631|NCT01610557|B3|Baseline|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748632|NCT01610557|B2|Baseline|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748633|NCT01610557|B1|Baseline|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748634|NCT01610557|P5|Participant Flow|Ranibizumab/Bevacizumab As Needed|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~53 participants attended at least one follow-up visit in the post-36-week extension phase: 49 participants who had one eye enrolled and 4 participants who had two eyes enrolled."
748635|NCT01610557|P4|Participant Flow|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748658|NCT01610453|P1|Participant Flow|Results From Transperineal Scan|"Primiparous women with prolonged labours was eligible for the study. Addenbrooke’s Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK and Department of Obstetrics and Gynecology, Stavanger University Hospital, Stavanger, Norway participated.~Ultrasound examination: a transperineal sonography was done when prolonged labor was diagnosed. Prolonged labor was diagnosed in accordance with WHO recommendations in Stavanger and in accordance with NICE guidelines in Cambridge"
748637|NCT01610557|P2|Participant Flow|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748638|NCT01610557|P1|Participant Flow|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748639|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
748640|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
748641|NCT01610557|O2|Outcome|Ranibizumab|Represents the estimated effect of ranibizumab for a 3-month period, adjusted for period and baseline value.
748642|NCT01610557|O1|Outcome|Bevacizumab|Represents the estimated effect of bevacizumab for a 3-month period, adjusted for period and baseline value.
748643|NCT01610557|E7|Reported Event|Ranibizumab and Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis. Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with two eyes assigned who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom one eye was assigned (unilateral participants) are not included."
748644|NCT01610557|E6|Reported Event|Bevacizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 3 or Group 4 in the crossover phase were injected with bevacizumab on an as-needed basis.~Participants with one eye assigned in either Group 3 or Group 4 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
748645|NCT01610557|E5|Reported Event|Ranibizumab As Needed (Post-36-Week Extension)|"Post-36-Week Extension Phase: Eyes assigned to Group 1 or Group 2 in the crossover phase were injected with ranibizumab on an as-needed basis.~Participants with one eye assigned in either Group 1 or Group 2 who had at least one follow-up visit in the post-36-week extension are included in the number of participants at risk.~Participants for whom two eyes were assigned (bilateral participants) are not included."
748646|NCT01610557|E4|Reported Event|Group 4 - Bevacizumab-Ranibizumab-Ranibizumab Injection Series|"Group 4 eyes were assigned to Bevacizumab-Ranibizumab-Ranibizumab (BRR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of ranibizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748647|NCT01610557|E3|Reported Event|Group 3 - Bevacizumab-Bevacizumab-Ranibizumab Injection Series|"Group 3 eyes were assigned to Bevacizumab-Bevacizumab-Ranibizumab (BBR) treatment sequence and received intravitreal injections of bevacizumab at baseline and Weeks 4, 8, 12, 16 and 20 (periods 1 and 2), then crossed over to receive intravitreal injections of ranibizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748648|NCT01610557|E2|Reported Event|Group 2 - Ranibizumab-Bevacizumab-Bevacizumab Injection Series|"Group 2 eyes were assigned to Ranibizumab-Bevacizumab-Bevacizumab (RBB) treatment sequence and received intravitreal injections of ranibizumab at baseline and Weeks 4 and 8 (period 1), then crossed over to receive intravitreal injections of bevacizumab at Weeks 12, 16, 20, 24, 28 and 32 (periods 2 and 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748649|NCT01610557|E1|Reported Event|Group 1 - Ranibizumab-Ranibizumab-Bevacizumab Injection Series|"Group 1 eyes were assigned to Ranibizumab-Ranibizumab-Bevacizumab (RRB) treatment sequence and received intravitreal injections of ranibizumab at baseline, Weeks 4, and 8 (period 1), and Weeks 12, 16 and 20 (period 2), then crossed over to receive intravitreal injections of bevacizumab at Weeks 24, 28 and 32 (period 3).~Participants for whom one eye was enrolled in the study had this eye randomly assigned to one of four groups. Participants for whom both eyes were enrolled had the right eye randomly assigned; the left eye was assigned to the group with the schedule inverse to that for the right eye."
748650|NCT01610492|B1|Baseline|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
748651|NCT01610492|P1|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
748652|NCT01610492|O1|Outcome|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) belimumab intravenous (IV) infusion every 4 weeks, over 24 weeks.
748669|NCT01610297|E1|Reported Event|ICL670|Oral dose of ICL670 at 10 mg/kg daily
748670|NCT01610167|B4|Baseline|Total|Total of all reporting groups
748671|NCT01610167|B3|Baseline|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748672|NCT01610167|B2|Baseline|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
760392|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
748675|NCT01610167|P2|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748676|NCT01610167|P1|Participant Flow|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748677|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748678|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748679|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748680|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748681|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748682|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748683|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748684|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748685|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748686|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748687|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748688|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748689|NCT01610167|O3|Outcome|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748690|NCT01610167|O2|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748691|NCT01610167|O1|Outcome|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748692|NCT01610167|E3|Reported Event|NUPRO(r) Classic Prophy Paste|NUPRO Classic Prophy Paste : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748693|NCT01610167|E2|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin(r) w/ Fluoride.|NUPRO Sensodyne Prophy Paste with Novamin with fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748694|NCT01610167|E1|Reported Event|NUPRO Sensodyne Prophy Paste w/ Novamin|NUPRO Sensodyne Prophy Paste with Novamin without fluoride. : Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
748695|NCT01610154|B1|Baseline|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
748696|NCT01610154|P1|Participant Flow|Sitagliptin Treatment|Sitagliptin 100 mg QD for 12 weeks
748697|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
748698|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
748699|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
748700|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
748701|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
748702|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
748703|NCT01610154|O2|Outcome|Obese Group|BMI≥25 kg/m2
748704|NCT01610154|O1|Outcome|Non-obese Group|BMI<25 kg/m2
748705|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
748706|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
748707|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
748708|NCT01610154|O1|Outcome|Sitagliptin|Sitagliptin 100 mg QD
748709|NCT01610154|E1|Reported Event|Sitagliptin Treatment|Sitagliptin 100 mg QD
748710|NCT01610076|B3|Baseline|Total|Total of all reporting groups
748711|NCT01610076|B2|Baseline|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
748712|NCT01610076|B1|Baseline|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
748713|NCT01610076|P2|Participant Flow|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
748714|NCT01610076|P1|Participant Flow|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
748715|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
748716|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
748717|NCT01610076|O1|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
748718|NCT01610076|O2|Outcome|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
748779|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748720|NCT01610076|E2|Reported Event|Code Status Video|"This group views a 10 minute video about code status prior to knowledge base survey administration~Code Status Video: 10 minute video about Code Status"
748721|NCT01610076|E1|Reported Event|No Video - Control|"This group does not watch the 10 minute code status video before having the knowledge base video administered."
748722|NCT01610063|B3|Baseline|Total|Total of all reporting groups
748723|NCT01610063|B2|Baseline|Unguided|Treatment as usual
748724|NCT01610063|B1|Baseline|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748725|NCT01610063|P2|Participant Flow|Unguided|Treatment as usual
748726|NCT01610063|P1|Participant Flow|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748727|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748728|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748729|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748730|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748731|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748732|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748733|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748734|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748735|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748736|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748737|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748738|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748739|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748740|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748741|NCT01610063|O2|Outcome|Unguided|Treatment as usual
748742|NCT01610063|O1|Outcome|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748743|NCT01610063|E2|Reported Event|Unguided|Treatment as usual
748744|NCT01610063|E1|Reported Event|Guided|A pharmacogenomic algorithm (GeneSight) guided treatment decisions for antidepressant medication selection and appropriate dosing.
748745|NCT01610037|B4|Baseline|Total|Total of all reporting groups
748746|NCT01610037|B3|Baseline|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748747|NCT01610037|B2|Baseline|Tiotropium|18 μg capsules for inhalation, o.d
748748|NCT01610037|B1|Baseline|QVA149|110/50 µg capsules for inhalation, o.d
748749|NCT01610037|P3|Participant Flow|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748750|NCT01610037|P2|Participant Flow|Tiotropium|18 μg capsules for inhalation, o.d
748751|NCT01610037|P1|Participant Flow|QVA149|110/50 µg capsules for inhalation, o.d
748752|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748753|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748754|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748755|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748756|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748757|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748758|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748759|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748760|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748761|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748762|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748763|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748764|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748765|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748766|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748767|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748768|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748769|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
754189|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
748770|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748771|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748772|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748773|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748774|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748775|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748776|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748777|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748785|NCT01610037|O3|Outcome|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748786|NCT01610037|O2|Outcome|Tiotropium 18 µg o.d|18 μg capsules for inhalation, o.d
748787|NCT01610037|O1|Outcome|QVA149|110/50 µg capsules for inhalation, o.d
748788|NCT01610037|E3|Reported Event|Placebo|To match QVA149 capsules for inhalation, o.d To match tiotropium capsules for inhalation, o.d
748789|NCT01610037|E2|Reported Event|Tiotropium|18 μg capsules for inhalation, o.d
748790|NCT01610037|E1|Reported Event|QVA 149|110/50 µg capsules for inhalation, o.d
748791|NCT01610011|B3|Baseline|Total|Total of all reporting groups
748792|NCT01610011|B2|Baseline|Glycine Administration GLDC Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
748793|NCT01610011|B1|Baseline|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
748794|NCT01610011|P2|Participant Flow|Glycine Administration GLDC Mutation Subjects|Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics. Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage.
748795|NCT01610011|P1|Participant Flow|Glycine Administration|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
748796|NCT01610011|O2|Outcome|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
748797|NCT01610011|O1|Outcome|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
748798|NCT01610011|E2|Reported Event|Glycine Administration GLDC Mutation Subjects|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
748799|NCT01610011|E1|Reported Event|Glycine Administration Controls|"Glycine will be administered once orally to all subjects to determine brain and plasma pharmacodynamics.~Glycine administration: Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage."
748800|NCT01609790|B4|Baseline|Total|Total of all reporting groups
748801|NCT01609790|B3|Baseline|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748802|NCT01609790|B2|Baseline|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748803|NCT01609790|B1|Baseline|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748804|NCT01609790|P3|Participant Flow|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748805|NCT01609790|P2|Participant Flow|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748806|NCT01609790|P1|Participant Flow|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748807|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
749118|NCT01608659|E1|Reported Event|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
748808|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748809|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748810|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748811|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748812|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748813|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748814|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748815|NCT01609790|O2|Outcome|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748858|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748816|NCT01609790|O1|Outcome|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748817|NCT01609790|O1|Outcome|Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748818|NCT01609790|E3|Reported Event|Cohort 2: Bevacizumab+AMG 386|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748819|NCT01609790|E2|Reported Event|Cohort 2: Bevacizumab+Placebo|Bevacizumab every 2 weeks + placebo weekly until disease progression. Patients who progress will be allowed to cross over and receive treatment with bevacizumab + AMG 386
748820|NCT01609790|E1|Reported Event|Cohort 1: Safety Run-In|Bevacizumab every 2 weeks + AMG 386 weekly until disease progression.
748821|NCT01609582|B3|Baseline|Total|Total of all reporting groups
748822|NCT01609582|B2|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
748823|NCT01609582|B1|Baseline|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
748824|NCT01609582|P2|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
748825|NCT01609582|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
748826|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
748827|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
748828|NCT01609582|O2|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
748829|NCT01609582|O1|Outcome|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
748830|NCT01609582|E2|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablet, orally, once daily for up to 582 days.
748831|NCT01609582|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablet, orally, once daily for up to 588 days.
748832|NCT01609543|B1|Baseline|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
748833|NCT01609543|P1|Participant Flow|Erlotinib Hydrochloride|Participants received a single 150 milligrams (mg) oral dose of erlotinib hydrochloride (Tarceva) tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
748834|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
748835|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
748836|NCT01609543|O1|Outcome|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity, or consent withdrawal, whichever occurred first up to 34 months.
748837|NCT01609543|E1|Reported Event|Erlotinib Hydrochloride|Participants received a single 150 mg oral dose of erlotinib hydrochloride tablet daily from Day 1 until disease progression, death, unacceptable toxicity or consent withdrawal, whichever occurred first up to 34 months.
748838|NCT01609478|B4|Baseline|Total|Total of all reporting groups
748839|NCT01609478|B3|Baseline|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748840|NCT01609478|B2|Baseline|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748841|NCT01609478|B1|Baseline|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748842|NCT01609478|P3|Participant Flow|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748843|NCT01609478|P2|Participant Flow|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748844|NCT01609478|P1|Participant Flow|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748845|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748846|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748847|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748848|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748849|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748850|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748851|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748852|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748853|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748854|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748855|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748856|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748857|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748944|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748859|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748860|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748861|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748862|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748863|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748864|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748865|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748866|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748867|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748868|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748869|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748870|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748871|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748872|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748873|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748874|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748875|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748876|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748877|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748878|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748879|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748880|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748881|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748882|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748883|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748884|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748885|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748886|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748887|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748888|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748889|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748890|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748891|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748892|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
749119|NCT01608321|B3|Baseline|Total|Total of all reporting groups
748893|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748894|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748895|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748896|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748897|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748898|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748899|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748900|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748901|NCT01609478|O3|Outcome|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748902|NCT01609478|O2|Outcome|Indacaterol Acetate 150 µg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748903|NCT01609478|O1|Outcome|Indacaterol Acetate 75 µg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748904|NCT01609478|E3|Reported Event|Placebo|placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748905|NCT01609478|E2|Reported Event|Indacaterol Acetate 150 mcg|indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748906|NCT01609478|E1|Reported Event|Indacaterol Acetate 75 mcg|indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
748907|NCT01609257|B3|Baseline|Total|Total of all reporting groups
748908|NCT01609257|B2|Baseline|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748909|NCT01609257|B1|Baseline|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748910|NCT01609257|P2|Participant Flow|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748911|NCT01609257|P1|Participant Flow|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748912|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748913|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748914|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748915|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748916|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748917|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748918|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748919|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748920|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748921|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748922|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748923|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748924|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748925|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748926|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748927|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748928|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748929|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748930|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748931|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748932|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748933|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748934|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
749368|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
748935|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748936|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748937|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748938|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748939|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748940|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748941|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748942|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748943|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748945|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748946|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748947|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748948|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748949|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748950|NCT01609257|O2|Outcome|Placebo_Not Infected|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748951|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748952|NCT01609257|O2|Outcome|Placebo_Not Ill|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748953|NCT01609257|O1|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748954|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748955|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748956|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748957|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748958|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748959|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748960|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748961|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748962|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748963|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748964|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748965|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748966|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748967|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748968|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748969|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748970|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748971|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748972|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748973|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748974|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748975|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748976|NCT01609257|O2|Outcome|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
749369|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
748977|NCT01609257|O1|Outcome|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748978|NCT01609257|E2|Reported Event|Placebo|Saline (0.9% NaCl and preservative-free), IM, Days 0 and 28.
748979|NCT01609257|E1|Reported Event|Norovirus Bivalent VLP Vaccine|Norovirus Bivalent virus like particle (VLP) Vaccine (50 μg of GI.1 Norwalk VLP and 50 μg of GII.4 cVLP) adjuvanted with MPL and AI(OH)3, intramuscular (IM), Days 0 and 28.
748980|NCT01609062|B3|Baseline|Total|Total of all reporting groups
748981|NCT01609062|B2|Baseline|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748982|NCT01609062|B1|Baseline|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748983|NCT01609062|P2|Participant Flow|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748984|NCT01609062|P1|Participant Flow|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748985|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749080|NCT01608815|B2|Baseline|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
748986|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748987|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748988|NCT01609062|O3|Outcome|All Subjects|Both groups combined
748989|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748990|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748991|NCT01609062|O3|Outcome|All Subjects|Both groups combined
748992|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748993|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748994|NCT01609062|O3|Outcome|All Subjects|Both groups combined
748995|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748996|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748997|NCT01609062|O3|Outcome|All Subjects|Both groups combined
748998|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
748999|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749000|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749001|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749002|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749003|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749004|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749005|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749006|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749007|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749008|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749009|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749010|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749011|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749012|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749013|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749014|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749015|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749016|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749017|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749018|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749019|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
754190|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
749020|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749021|NCT01609062|O3|Outcome|All Subjects|Both groups combined
749022|NCT01609062|O2|Outcome|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749023|NCT01609062|O1|Outcome|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749024|NCT01609062|E2|Reported Event|BMN 110 Weekly at 4.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749025|NCT01609062|E1|Reported Event|BMN 110 Weekly at 2.0 mg/kg/Week|BMN 110: Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion in the primary phase.
749026|NCT01609023|B1|Baseline|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749081|NCT01608815|B1|Baseline|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749027|NCT01609023|P1|Participant Flow|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749028|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749029|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749030|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749031|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749032|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749033|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749034|NCT01609023|O1|Outcome|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749035|NCT01609023|E1|Reported Event|Rituximab|Participants with chronic lymphocytic leukemia treated with rituximab in combination with chemotherapy according to Summary of Product Characteristics (SPC) and routine clinical practice were observed for 24 months.
749036|NCT01609010|B3|Baseline|Total|Total of all reporting groups
749037|NCT01609010|B2|Baseline|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749038|NCT01609010|B1|Baseline|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749039|NCT01609010|P2|Participant Flow|Rituximab + Interferon (IFN)|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-alpha2a (IFN-α2a), 3 million international units per day (MIU/day), subcutaneously (SC), during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749040|NCT01609010|P1|Participant Flow|Rituximab Monotherapy|Participants rituximab received 375 milligrams per square meter (mg/m^2), intravenously (IV), once weekly for 4 weeks. Participants who achieved minor response (MR), partial response (PR), or complete response (CR) after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749041|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749042|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749043|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749044|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749045|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749370|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749046|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749047|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749048|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749049|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749050|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749051|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749052|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749053|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749054|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749055|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749056|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749057|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749058|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749059|NCT01609010|O2|Outcome|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749060|NCT01609010|O1|Outcome|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749061|NCT01609010|E2|Reported Event|Rituximab + IFN|Participants received rituximab 375 mg/m^2, IV, once weekly for 4 weeks. Participants also received IFN-α2a 3 MIU/day, SC, during Week 1, and 4.5 MIU/day, SC, 6 days per week during Weeks 2 through 5. IFN-α2a was not administered on days of rituximab administration. Participants who achieved MR, PR, or CR during the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749062|NCT01609010|E1|Reported Event|Rituximab Monotherapy|Participants rituximab received 375 mg/m^2, IV, once weekly for 4 weeks. Participants who achieved MR, PR, or CR after the first cycle received a second cycle of treatment for a maximum of 2 cycles.
749063|NCT01608971|B3|Baseline|Total|Total of all reporting groups
749064|NCT01608971|B2|Baseline|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
749065|NCT01608971|B1|Baseline|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
749066|NCT01608971|P2|Participant Flow|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
749067|NCT01608971|P1|Participant Flow|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
749068|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
749069|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
749070|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
749071|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
749072|NCT01608971|O2|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
749073|NCT01608971|O1|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
749074|NCT01608971|O2|Outcome|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
749075|NCT01608971|O1|Outcome|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
749076|NCT01608971|E2|Reported Event|Weight Based Protamine Group|In this group the dose of protamine is calculated by the weight of the patients (400 IU/kg)
749077|NCT01608971|E1|Reported Event|Heparin Level Based Protamine Group|In this group the protamine dose will be calculated 1:1 according to the heparin level measured after termination of cardiopulmonary bypass.
749078|NCT01608815|B4|Baseline|Total|Total of all reporting groups
749079|NCT01608815|B3|Baseline|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749082|NCT01608815|P3|Participant Flow|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749083|NCT01608815|P2|Participant Flow|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749084|NCT01608815|P1|Participant Flow|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749085|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749086|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749087|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749088|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749089|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749090|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749091|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749092|NCT01608815|O2|Outcome|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749093|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749094|NCT01608815|O3|Outcome|Children (Group 3)|Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749095|NCT01608815|O2|Outcome|Dolescents (Group 2)|Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749096|NCT01608815|O1|Outcome|Adults (Group 1)|Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
749097|NCT01608815|E3|Reported Event|Children (Group 3)|Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
749098|NCT01608815|E2|Reported Event|Adolescents (Group 2)|Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
749099|NCT01608815|E1|Reported Event|Adults (Group 1)|Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
749100|NCT01608724|B1|Baseline|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
749101|NCT01608724|P1|Participant Flow|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
749102|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
749103|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
749104|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
749105|NCT01608724|O1|Outcome|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
749106|NCT01608724|E1|Reported Event|Saxagliptin|Saxagliptin oral 5mg once a day(Q. D.) for 24 weeks
749107|NCT01608672|B1|Baseline|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
749108|NCT01608672|P1|Participant Flow|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
749109|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
749110|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
749111|NCT01608672|O1|Outcome|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
749112|NCT01608672|E1|Reported Event|All Participants|Botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over a period of at least 5 years.
749113|NCT01608659|B1|Baseline|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
749114|NCT01608659|P1|Participant Flow|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
749115|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
749116|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
749117|NCT01608659|O1|Outcome|Botulinum Toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
749120|NCT01608321|B2|Baseline|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
749121|NCT01608321|B1|Baseline|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
749122|NCT01608321|P2|Participant Flow|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
749123|NCT01608321|P1|Participant Flow|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
749124|NCT01608321|O2|Outcome|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
749125|NCT01608321|O1|Outcome|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
749126|NCT01608321|E2|Reported Event|Sham rTMS|"Those receiving the sham rTMS will receive 20 sessions of sham rTMS. The treatment will be delivered by trained medical personnel.~Sham device: Placebo Device that simulates active rTMS treatment"
749127|NCT01608321|E1|Reported Event|rTMS|"Those receiving experimental treatment will receive 20 sessions of rTMS. The treatment will be delivered by trained medical personnel.~rTMS: Repetitive Transcranial Magnetic Stimulation"
749128|NCT01608308|B3|Baseline|Total|Total of all reporting groups
749129|NCT01608308|B2|Baseline|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749130|NCT01608308|B1|Baseline|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749131|NCT01608308|P2|Participant Flow|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749132|NCT01608308|P1|Participant Flow|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with acetyl-para-aminophenol (APAP, also known as acetaminophen) concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749133|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749134|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749135|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749136|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749137|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749163|NCT01608295|O1|Outcome|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
749138|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749139|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749140|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749378|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749141|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749142|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749143|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749144|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749145|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749146|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749147|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749148|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749149|NCT01608308|O2|Outcome|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749150|NCT01608308|O1|Outcome|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749164|NCT01608295|E2|Reported Event|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
754191|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
749151|NCT01608308|E2|Reported Event|Control|"The control group (Placebo) will receive 100 mL of 0.9% normal saline in place of IV acetaminophen in the same manner as the experimental group; the investigator/physician in question will be blinded to the agent that is being administered. Patients will be discharged with instruction to continue APAP 500 mg PO every 6-8 hours. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~Placebo: 100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen."
749152|NCT01608308|E1|Reported Event|IV Acetaminophen|"The experimental group will receive a preoperative dose of 1000mg IV acetaminophen over 15 minutes. This will occur at least 15 minutes before the start of surgery. Another 1000mg dose of IV acetaminophen will be administered 4 hours after the first dose. A rescue analgesic containing oxycodone will also be provided (with APAP concentrations of 325 mg per Hospital and FDA recommendations).~IV Acetaminophen: 1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses."
749153|NCT01608295|B3|Baseline|Total|Total of all reporting groups
749211|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
760393|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
749154|NCT01608295|B2|Baseline|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
749155|NCT01608295|B1|Baseline|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
749156|NCT01608295|P2|Participant Flow|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
749157|NCT01608295|P1|Participant Flow|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
749158|NCT01608295|O2|Outcome|Paroxetine; Paxil|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety."
749159|NCT01608295|O1|Outcome|Vilazodone; Viibryd|"After screening and baseline test results are reviewed and eligibility criteria are confirmed, medications will be dispensed if patients continue to meet eligibility criteria and sign the informed consent form. All eligible subjects will be randomized to vilazodone or paroxetine group using a computer-generated random assignment scheme, which assigned subjects in a 1:1 ratio to each group. Randomization will be done prior to subject's being assigned to the groups. Doses of the drugs will be adjusted according to individual tolerability and safety.~Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety."
749160|NCT01608295|O2|Outcome|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
749161|NCT01608295|O1|Outcome|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
749162|NCT01608295|O2|Outcome|Paroxetine; Paxil|Paroxetine; Paxil: Subjects randomized to receive paroxetine blindly received incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs were adjusted according to individual tolerability and safety.
749993|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749165|NCT01608295|E1|Reported Event|Vilazodone; Viibryd|Vilazodone; Viibryd: Subjects randomized to receive vilazodone blindly received incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
749166|NCT01608100|B1|Baseline|ARCHITECT STAT High Sensitive Troponin I Assay Testing|All subjects will have their blood tested by the investigational ARCHITECT STAT High Sensitive Troponin I assay. Specimens were collected at 11 emergency departments from 1,101 subjects presenting to the emergency department with symptoms consistent with acute coronary syndrome (ACS). All subject diagnoses were adjudicated by three board certified cardiologists according to current standard of care.
749212|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749167|NCT01608100|P1|Participant Flow|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
749168|NCT01608100|O3|Outcome|Positive Predictive Value in Serum Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749169|NCT01608100|O2|Outcome|Positive Predictive Value in Lithium Heparin Separator|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749170|NCT01608100|O1|Outcome|Positive Predictive Value in K2 EDTA|Positive Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749171|NCT01608100|O3|Outcome|Negative Predictive Value in Serum Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
749172|NCT01608100|O2|Outcome|Negative Predictive Value in Lithium Heparin Separator|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
749173|NCT01608100|O1|Outcome|Negative Predictive Value in K2 EDTA|Negative Predictive Value for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff 26.2 pg/mL).
749174|NCT01608100|O3|Outcome|Specificity in Serum Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
749175|NCT01608100|O2|Outcome|Specificity in Lithium Heparin Separator|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
749176|NCT01608100|O1|Outcome|Specificity in K2 EDTA|Specificity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
749177|NCT01608100|O3|Outcome|Sensitivity in Serum Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749178|NCT01608100|O2|Outcome|Sensitivity in Lithium Heparin Separator|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall (99th percentile cutoff 26.2 pg/mL).
749179|NCT01608100|O1|Outcome|Sensitivity in K2 EDTA|Sensitivity for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749180|NCT01608100|O6|Outcome|90-day Prognosis for Serum Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
749181|NCT01608100|O5|Outcome|30-day Prognosis for Serum Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
749182|NCT01608100|O4|Outcome|90-day Prognosis for Lithium Heparin Separator Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
749183|NCT01608100|O3|Outcome|30-day Prognosis for Lithium Heparin Separator Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
749184|NCT01608100|O2|Outcome|90-day Prognosis for K2 EDTA Tube Type|The 90-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
749185|NCT01608100|O1|Outcome|30-day Prognosis for K2 EDTA Tube Type|The 30-day prognosis (Kaplan-Meier analysis) and hazard ratios (Cox regression) for the overall 99th percentile cutoff (26.2 pg/mL) were calculated.
749186|NCT01608100|O3|Outcome|Area Under the Curve in Serum Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Serum tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749187|NCT01608100|O2|Outcome|Area Under the Curve in Lithium Heparin Separator|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using Lithium Heparin tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749188|NCT01608100|O1|Outcome|Area Under the Curve in K2 EDTA|Area Under the Curve for the ARCHITECT High Sensitive Troponin I was evaluated using K2 EDTA tube type for 3 collection time points. The results were calculated using the overall 99th percentile cutoff (26.2 pg/mL).
749306|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749189|NCT01608100|E1|Reported Event|ARCHITECT STAT High Sensitive Troponin I Assay Testing|"All subjects will have their blood tested by the investigational Troponin I assay.~ARCHITECT STAT High Sensitive Troponin I Assay: Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay.~Results obtained will be used to assess the prognosis of subjects with a troponin result for risk of ACM/MACE in the time frames (30 days and 90 days) after the Emergency Department visit.~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
749379|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
760394|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
749190|NCT01607853|B1|Baseline|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749191|NCT01607853|P1|Participant Flow|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749192|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749193|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749194|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749195|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749196|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749197|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749198|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749199|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749200|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749201|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749202|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749203|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749204|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749205|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749206|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749207|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749208|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749209|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749334|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
749994|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749210|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749213|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749214|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749215|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749216|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749217|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749218|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749219|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749220|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749221|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749222|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749223|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749224|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749225|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749226|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749227|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749228|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749229|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749230|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749231|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749232|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749233|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749335|NCT01607593|E1|Reported Event|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians
749336|NCT01607476|B4|Baseline|Total|Total of all reporting groups
749234|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749235|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749236|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749237|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749238|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749239|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749240|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749241|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749242|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749243|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749244|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749245|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749246|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749247|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749248|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749249|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749250|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749251|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749252|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749253|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749254|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749255|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749256|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749257|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749365|NCT01607450|P2|Participant Flow|Lean GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
750637|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
749258|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749259|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749260|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749261|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749262|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749263|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749264|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749265|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749266|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749267|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749268|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749269|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749270|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749271|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749272|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749273|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749274|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749275|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749276|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749277|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749278|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749279|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749280|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749281|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749366|NCT01607450|P1|Participant Flow|Lean Placebo|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
754192|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
749282|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749283|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749284|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749285|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749286|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749287|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749288|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749289|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749290|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749291|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749292|NCT01607853|O4|Outcome|Daivobet® Gel Vehicle Applied for 24 Hours|"Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749293|NCT01607853|O3|Outcome|Daivobet® Gel Applied for 24 Hours|"- Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749294|NCT01607853|O2|Outcome|Daivobet® Gel Applied Then Removed After 20 Minutes|"- Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749295|NCT01607853|O1|Outcome|Daivobet® Gel Applied Then Removed After 10 Minutes|"Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749296|NCT01607853|E1|Reported Event|Daivobet® Gel|"Each of the 24 subjects participating in this exploratory trial received:~Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel vehicle applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes) : Once daily application, 3 weeks~Daivobet® gel applied for 24 hours (+/- 2 hours) : Once daily application, 3 weeks~The products were applied on 4 test sites of 2 cm according to random assignment to specific sites on one psoriasis plaque."
749297|NCT01607645|B3|Baseline|Total|Total of all reporting groups
749298|NCT01607645|B2|Baseline|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749299|NCT01607645|B1|Baseline|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749300|NCT01607645|P2|Participant Flow|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749301|NCT01607645|P1|Participant Flow|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749302|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749303|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749304|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749305|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749367|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
749307|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749308|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749309|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749310|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749311|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749312|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749313|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749314|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749315|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749316|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749317|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749318|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749319|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749320|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749321|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749322|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749323|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749324|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749325|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749326|NCT01607645|O2|Outcome|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749327|NCT01607645|O1|Outcome|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749328|NCT01607645|E2|Reported Event|Arm II (Decitabine (Day -9 to Day -5), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -9 to -5 and cytarabine and idarubicin as in Arm I.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749329|NCT01607645|E1|Reported Event|Arm I (Decitabine Day -4 to Day 0), Idarubicin, Cytarabine)|"Patients receive decitabine IV over 1 hour on days -4 to 0, cytarabine IV continuously over 24 hours on days 1-7, and idarubicin IV over 10-15 minutes on days 1-3.~decitabine: Given IV~idarubicin: Given IV~cytarabine: Given IV"
749330|NCT01607593|B1|Baseline|SERTRALINE|Participants with PTSD who were treated with sertraline as instructed by physicians.
749331|NCT01607593|P1|Participant Flow|SERTRALINE|Participants with post-traumatic stress disorder (PTSD) who were treated with sertraline as instructed by physicians
749332|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
749333|NCT01607593|O1|Outcome|Sertraline (Zoloft)|Participants with PTSD who were treated with sertraline as instructed by physicians
749337|NCT01607476|B3|Baseline|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749338|NCT01607476|B2|Baseline|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749339|NCT01607476|B1|Baseline|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
750006|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749340|NCT01607476|P3|Participant Flow|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749341|NCT01607476|P2|Participant Flow|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749342|NCT01607476|P1|Participant Flow|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable Alzheimer's disease (AD) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR). Interventions include C11 Pittsburgh Compound B (PiB) PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 millicurie (mCi) C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749343|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749344|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749345|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749346|NCT01607476|O3|Outcome|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749347|NCT01607476|O2|Outcome|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749348|NCT01607476|O1|Outcome|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749349|NCT01607476|E3|Reported Event|Cognitive Normal Young|"Cognitively normal subjects who are between 30-60 years old. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749350|NCT01607476|E2|Reported Event|Cognitive Normal Elderly|"Cognitive Normal subjects who are greater than 60 years of age. Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749351|NCT01607476|E1|Reported Event|Alzheimer's Disease|"Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR).~Interventions include C11 PiB PET/CT, F-18 Flutametamol PET/CT.~C11 PiB: One time intravenous administration of 8-22 mCi C11 PiB~F18 Flutametamol: One time intravenous administration of 3-7 mCi F18 Flutametamol."
749352|NCT01607450|B8|Baseline|Total|Total of all reporting groups
749353|NCT01607450|B7|Baseline|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
749354|NCT01607450|B6|Baseline|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
749355|NCT01607450|B5|Baseline|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749356|NCT01607450|B4|Baseline|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749357|NCT01607450|B3|Baseline|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749358|NCT01607450|B2|Baseline|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749359|NCT01607450|B1|Baseline|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
749360|NCT01607450|P7|Participant Flow|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749361|NCT01607450|P6|Participant Flow|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749362|NCT01607450|P5|Participant Flow|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749363|NCT01607450|P4|Participant Flow|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749364|NCT01607450|P3|Participant Flow|Type 2 DM GLP-1 Mid-Range Dose|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749371|NCT01607450|O3|Outcome|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749372|NCT01607450|O2|Outcome|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749373|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
749374|NCT01607450|O7|Outcome|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
749375|NCT01607450|O6|Outcome|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose:4.0 pmol/kg/min for 12 hours prior to PET study
749376|NCT01607450|O5|Outcome|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749377|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
760395|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
749380|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
749381|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749382|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749383|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749384|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749385|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749386|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749387|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
749388|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749389|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749390|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749391|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749392|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749393|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749394|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
749395|NCT01607450|O7|Outcome|Type 2 DM GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749396|NCT01607450|O6|Outcome|Lean GLP-1 High Dose|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749397|NCT01607450|O5|Outcome|Type 2DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749398|NCT01607450|O4|Outcome|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749399|NCT01607450|O3|Outcome|Type 2 DM GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749400|NCT01607450|O2|Outcome|Lean GLP-1 Low Dose|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749401|NCT01607450|O1|Outcome|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
749402|NCT01607450|E7|Reported Event|Type 2 DM GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749403|NCT01607450|E6|Reported Event|Lean GLP-1 4.0 Pmol/kg/Min|GLP-1 High Dose: 4.0 pmol/kg/min for 12 hours prior to PET study
749404|NCT01607450|E5|Reported Event|Type 2 DM GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749405|NCT01607450|E4|Reported Event|Lean GLP-1 1.5 Pmol/kg/Min|GLP-1 Mid-Range Dose: 1.5 pmol/kg/min for 12 hours prior to PET study
749406|NCT01607450|E3|Reported Event|Type 2 DM GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749407|NCT01607450|E2|Reported Event|Lean GLP-1 0.5 Pmol/kg/Min|GLP-1 Low Dose: 0.5 pmol/kg/min for 12 hours prior to PET study
749408|NCT01607450|E1|Reported Event|Lean Saline|"12 hour placebo (saline) infusion prior to PET study~Placebo: Saline placebo infusion for 12 hours prior to PET study"
749409|NCT01607411|B1|Baseline|Overall|All randomized participants who received atleast one dose of the study treatments
749410|NCT01607411|P4|Participant Flow|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749411|NCT01607411|P3|Participant Flow|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749412|NCT01607411|P2|Participant Flow|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749413|NCT01607411|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste (1426parts Per Million(Ppm) F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 grams (g) ± 0.1g of NaF toothpaste(1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749435|NCT01607398|B1|Baseline|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749414|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749415|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749416|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749489|NCT01607203|P1|Participant Flow|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
749417|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749418|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749419|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749420|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749421|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749422|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749423|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749424|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749425|NCT01607411|O4|Outcome|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749426|NCT01607411|O3|Outcome|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749427|NCT01607411|O2|Outcome|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749428|NCT01607411|O1|Outcome|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749429|NCT01607411|E4|Reported Event|Placebo Toothpaste (0 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (0ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749430|NCT01607411|E3|Reported Event|NaF Toothpaste (500 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (500 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749431|NCT01607411|E2|Reported Event|NaF Toothpaste (1000 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1000 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749432|NCT01607411|E1|Reported Event|NaF Toothpaste (1426 Ppm F)|Participants were fitted with enamel specimen appliance in the palatal surface 5 minutes before treatment initiation. Participants brushed their teeth for one timed minute with 1.0 g ± 0.1g of NaF toothpaste (1426 ppm F) and expectorated. The direct contact between palatal appliance and toothbrush was avoided
749433|NCT01607398|B3|Baseline|Total|Total of all reporting groups
749434|NCT01607398|B2|Baseline|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749436|NCT01607398|P2|Participant Flow|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749437|NCT01607398|P1|Participant Flow|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749438|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749605|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
749439|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749440|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749441|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749442|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749443|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749444|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749445|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749446|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749447|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749448|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749449|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749450|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749451|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749452|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749453|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749454|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749455|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749456|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749457|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749458|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749459|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749599|NCT01606319|P2|Participant Flow|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
749460|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749461|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749462|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749463|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749464|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749465|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749466|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749467|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749468|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749469|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749470|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749471|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749472|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749473|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749474|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749475|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749476|NCT01607398|O2|Outcome|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749477|NCT01607398|O1|Outcome|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749478|NCT01607398|E2|Reported Event|ADOAIR 250|Participants self-administered one inhalation of ADOAIR 250 (salmeterol 50 micrograms [µg] and fluticasone propionate 250 µg) powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749479|NCT01607398|E1|Reported Event|Placebo|Participants self-administered one inhalation of placebo powder twice daily from a dry powder inhaler for 12 weeks. Participants used oxitropium (a short-acting anticholinergic drug) as a relief medication during the study.
749480|NCT01607320|B1|Baseline|All Study Participants|Participants were randomized to receive one of the two following interventions, but the study was terminated and data will not be unblinded: 1) 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 with Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal; or 2) 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 with Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
749481|NCT01607320|P2|Participant Flow|Clomiphene|"3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7~Clomiphene: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal"
749482|NCT01607320|P1|Participant Flow|Raloxifene|"3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7~Raloxifene: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal"
749483|NCT01607320|O1|Outcome|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
749484|NCT01607320|E1|Reported Event|All Study Participants|The study was randomized between the two treatments and was never unblinded, threfore randomization is unknown.
749485|NCT01607203|B3|Baseline|Total|Total of all reporting groups
749486|NCT01607203|B2|Baseline|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
749487|NCT01607203|B1|Baseline|HCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
749488|NCT01607203|P2|Participant Flow|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
750007|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749490|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
749491|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
749492|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
749493|NCT01607203|O1|Outcome|hCG Triggering|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
749494|NCT01607203|O2|Outcome|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
749495|NCT01607203|O1|Outcome|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
749496|NCT01607203|E2|Reported Event|hCG and GnRH Agonist Triggering|DUAL TRIGGERING FOR FINAL MATURATION BY 5000IU PREGNYL SC AND DECAPEPTYL(GONAPEPTYL) 0.2 MG SC 36 HOURS BEFORE OOCYTE RETRIEVAL
749497|NCT01607203|E1|Reported Event|hCG TRIGGERING|TRIGGERING FOR FINAL MATURATION BY 5000 IU PREGNYL SC ONLY 36 HOURS BEFORE OOCYTE RETRIEVAL
749498|NCT01607112|B3|Baseline|Total|Total of all reporting groups
749499|NCT01607112|B2|Baseline|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749500|NCT01607112|B1|Baseline|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749501|NCT01607112|P2|Participant Flow|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749502|NCT01607112|P1|Participant Flow|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749503|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749504|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749505|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749506|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749507|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749508|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749509|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749510|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749511|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749512|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749513|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749514|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749515|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749516|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749601|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
749517|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749518|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749519|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749606|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
749520|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749521|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749522|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749523|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749524|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749525|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group Without Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and did not receive seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749526|NCT01607112|O1|Outcome|Fluarix/Influsplit > 60 Years Group With Vaccination|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0 and who had received seasonal Flu vaccination in 2011-2012. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749527|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749528|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749529|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749530|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749531|NCT01607112|O2|Outcome|Fluarix/Influsplit > 60 Years Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749532|NCT01607112|O1|Outcome|Fluarix/Influsplit 18-60 Years Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749533|NCT01607112|E2|Reported Event|Elderly Group|Subjects above 60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749534|NCT01607112|E1|Reported Event|Adult Group|Subjects 18-60 years of age received 1 dose of Fluarix/Influsplit SSW 2012-2013 vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
749535|NCT01606800|B3|Baseline|Total|Total of all reporting groups
749536|NCT01606800|B2|Baseline|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
749537|NCT01606800|B1|Baseline|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
749538|NCT01606800|P2|Participant Flow|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
749539|NCT01606800|P1|Participant Flow|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
749540|NCT01606800|O2|Outcome|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
749541|NCT01606800|O1|Outcome|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
749542|NCT01606800|E2|Reported Event|20 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving RVR after 4 weeks of PEG-INF alfa-2b + RBV treatment continued to receive PEG-INF alpha-2b + RBV for an additional 20 weeks.
749543|NCT01606800|E1|Reported Event|44 Weeks of PEG-IFN Alfa-2b + RBV|Participants achieving rapid virologic response (RVR) after 4 weeks of pegylated interferon (PEG-INF) alfa-2b + ribavirin (RBV) treatment continued to receive PEG-INF alpha-2b + RBV for an additional 44 weeks.
749544|NCT01606748|B3|Baseline|Total|Total of all reporting groups
749600|NCT01606319|P1|Participant Flow|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
749545|NCT01606748|B2|Baseline|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749607|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
749546|NCT01606748|B1|Baseline|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749547|NCT01606748|P2|Participant Flow|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab drug product manufactured using a new and comparable necitumumab drug substance (Process D drug product).~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749548|NCT01606748|P1|Participant Flow|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (IV) infusion at an absolute dose of 800 milligrams (mg). Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/square meter (m2).~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749549|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
749550|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
749551|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
749552|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 PK Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
749553|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
749554|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
749555|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749556|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749557|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
749558|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-in|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
749559|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749560|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749561|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749562|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
750638|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
749563|NCT01606748|O2|Outcome|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749564|NCT01606748|O1|Outcome|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product. Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749565|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.
749566|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-In|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg.
749567|NCT01606748|O2|Outcome|Cisplatin Cohort 1 Day 1, Cycle 1, Combination|Cisplatin administered 75 mg/m2 on Days 1 and 8 of every 3-week cycle as an IV infusion.
749568|NCT01606748|O1|Outcome|Cisplatin Cohort 1 Day 1 Run-in|Cisplatin administered on Day 1 of the 3-week PK run-in period as an IV infusion of 75 mg/m2.
749569|NCT01606748|O2|Outcome|Gemcitabine Cohort 1 Day 1, Cycle 1, Combination|Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2.
749570|NCT01606748|O1|Outcome|Gemcitabine Cohort 1 Day 1 PK Run-In|Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.
749571|NCT01606748|O2|Outcome|Necitumumab Cohort 1 Day 1, Cycle 1, Combination|Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
749572|NCT01606748|O1|Outcome|Necitumumab Cohort 1 Day 3 Run-in|Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Participants in Cohort 1 received necitumumab Process C drug product.
749573|NCT01606748|E2|Reported Event|Necitumumab Cohort 2|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749574|NCT01606748|E1|Reported Event|Necitumumab Cohort 1|"Necitumumab administered on Day 3 of the 3-week PK run-in period as an IV infusion at an absolute dose of 800 mg. Necitumumab administered on Days 1 and 8 of every 3-week cycle as an IV infusion at an absolute dose of 800 mg.~Participants in Cohort 1 received necitumumab Process C drug product and participants in Cohort 2 received necitumumab Process D drug product.~Gemcitabine administered on Day 1 of the 3-week PK run-in period as an IV infusion at a dose of 1250 mg/m2.~Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an IV infusion at a dose of 1250 mg/m2."
749575|NCT01606735|B4|Baseline|Total|Total of all reporting groups
749576|NCT01606735|B3|Baseline|697 mcg|IBI-10090: dexamethasone
749577|NCT01606735|B2|Baseline|517 mcg|IBI-10090: dexamethasone
749578|NCT01606735|B1|Baseline|342 mcg|IBI-10090: dexamethasone
749579|NCT01606735|P3|Participant Flow|697 mcg|IBI-10090: dexamethasone
749580|NCT01606735|P2|Participant Flow|517 mcg|IBI-10090: dexamethasone
749581|NCT01606735|P1|Participant Flow|342 mcg|IBI-10090: dexamethasone
749582|NCT01606735|O3|Outcome|697 mcg|IBI-10090: dexamethasone
749583|NCT01606735|O2|Outcome|517 mcg|IBI-10090: dexamethasone
749584|NCT01606735|O1|Outcome|342 mcg|IBI-10090: dexamethasone
749585|NCT01606735|E3|Reported Event|697 mcg|IBI-10090: dexamethasone
749586|NCT01606735|E2|Reported Event|517 mcg|IBI-10090: dexamethasone
749587|NCT01606735|E1|Reported Event|342 mcg|IBI-10090: dexamethasone
749588|NCT01606670|B1|Baseline|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749589|NCT01606670|P1|Participant Flow|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749590|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749591|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749592|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749593|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749594|NCT01606670|O1|Outcome|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749595|NCT01606670|E1|Reported Event|Neupro® Treatment|Routine treatment with Neupro® (2, 4, 6, 8, 10, 12, 14, 16 mg/24 h) as per approved label in the EU, which is applicable in the EU member states Germany and Austria.
749596|NCT01606319|B3|Baseline|Total|Total of all reporting groups
749597|NCT01606319|B2|Baseline|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
749598|NCT01606319|B1|Baseline|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
754193|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
749602|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
749603|NCT01606319|O2|Outcome|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
749604|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
750008|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749608|NCT01606319|O1|Outcome|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
749609|NCT01606319|E2|Reported Event|Ibuprofen|"ibuprofen given as needed for pain or fever~Ibuprofen: 9.4 mg/kg every 6 hours as needed"
749610|NCT01606319|E1|Reported Event|Acetaminophen|"acetaminophen given as needed for pain or fever~Acetaminophen: 15 mg/kg every 6 hours as needed"
749611|NCT01606306|B7|Baseline|Total|Total of all reporting groups
749612|NCT01606306|B6|Baseline|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
749613|NCT01606306|B5|Baseline|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
749614|NCT01606306|B4|Baseline|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
749615|NCT01606306|B3|Baseline|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
749616|NCT01606306|B2|Baseline|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
749617|NCT01606306|B1|Baseline|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
749618|NCT01606306|P6|Participant Flow|Crossover Sequence 6|as needed fluticasone propionate, followed by daily montelukast, followed by daily fluticasone propionate
749619|NCT01606306|P5|Participant Flow|Crossover Sequence 5|as needed fluticasone propionate, followed by daily fluticasone propionate, followed by daily montelukast
749620|NCT01606306|P4|Participant Flow|Crossover Sequence 4|daily montelukast, followed by daily fluticasone propionate, followed by as needed fluticasone propionate
749621|NCT01606306|P3|Participant Flow|Crossover Sequence 3|daily montelukast, followed by as needed fluticasone propionate, followed by daily fluticasone propionate
749622|NCT01606306|P2|Participant Flow|Crossover Sequence 2|daily fluticasone propionate, followed by as needed fluticasone propionate, followed by daily montelukast
749623|NCT01606306|P1|Participant Flow|Crossover Sequence 1|daily fluticasone propionate, followed by daily montelukast, followed by as needed fluticasone propionate
749624|NCT01606306|O1|Outcome|All Evaluable Participants|Differential response was determined in children completing at least two treatment periods and at least 50% of the daily diary entries for each period. Because placebo washouts were not performed, the data collected during the first two weeks of each period were not included in the analysis of ACDs. Days with missing diary data were also excluded from ACD determination.
749625|NCT01606306|E3|Reported Event|Daily LTRA|Daily leukotriene receptor antagonist (LTRA) treatment
749626|NCT01606306|E2|Reported Event|As-needed ICS|As-needed ICS plus short-acting beta agonist (as-needed ICS/SABA) rescue treatment.
749627|NCT01606306|E1|Reported Event|Daily ICS|Daily inhaled corticosteroid (ICS) treatment
749628|NCT01606254|B5|Baseline|Total|Total of all reporting groups
749629|NCT01606254|B4|Baseline|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749630|NCT01606254|B3|Baseline|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749631|NCT01606254|B2|Baseline|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749632|NCT01606254|B1|Baseline|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749633|NCT01606254|P4|Participant Flow|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749634|NCT01606254|P3|Participant Flow|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749635|NCT01606254|P2|Participant Flow|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749636|NCT01606254|P1|Participant Flow|Paliperidone Palmitate 50 mg|Paliperidone palmitate (JNS010) 50 milligram (mg) intramuscular (into the muscle) injection administered on Days 1, 8, 36 and 64.
749637|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749638|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749639|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749640|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749641|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749642|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749643|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
750639|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
749644|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749645|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749646|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749647|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749648|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749649|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749650|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749651|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749652|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749653|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749654|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749655|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749656|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749657|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749658|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749659|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749660|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749661|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749662|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749663|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749664|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749665|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749666|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749667|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749668|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749669|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749670|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749671|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749672|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749673|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749674|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749675|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749676|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749677|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749678|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749679|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749680|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749681|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749682|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749683|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749684|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749685|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749686|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749687|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749688|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749689|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749690|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749691|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749692|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749693|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749694|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749695|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749696|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749697|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749698|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749699|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749700|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749701|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749702|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749703|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749704|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749705|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749706|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749707|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749708|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749709|NCT01606254|O4|Outcome|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749710|NCT01606254|O3|Outcome|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749711|NCT01606254|O2|Outcome|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749712|NCT01606254|O1|Outcome|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749713|NCT01606254|E4|Reported Event|Paliperidone Palmitate 150/ 50 mg|Paliperidone palmitate 150 mg intramuscular injection administered on Day 1 and paliperidone palmitate 50 mg intramuscular injection administered on Days 8, 36 and 64.
749714|NCT01606254|E3|Reported Event|Paliperidone Palmitate 150 mg|Paliperidone palmitate 150 mg intramuscular injections administered on Days 1, 8, 36 and 64.
749715|NCT01606254|E2|Reported Event|Paliperidone Palmitate 100 mg|Paliperidone palmitate 100 mg intramuscular injection administered on Days 1, 8, 36 and 64.
749716|NCT01606254|E1|Reported Event|Paliperidone Palmitate 50 mg|Paliperidone palmitate 50 milligram (mg) intramuscular injection administered on Days 1, 8, 36 and 64.
749717|NCT01606228|B1|Baseline|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749718|NCT01606228|P1|Participant Flow|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749719|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749720|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749721|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749722|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749723|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749724|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749725|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749726|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749727|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749728|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749729|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749730|NCT01606228|O1|Outcome|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749731|NCT01606228|E1|Reported Event|Paliperidone Extended-release (ER)|Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
749732|NCT01606202|B3|Baseline|Total|Total of all reporting groups
749733|NCT01606202|B2|Baseline|Placebo|Placebo control.
749734|NCT01606202|B1|Baseline|GW-1000-02|Active treatment.
749735|NCT01606202|P2|Participant Flow|Placebo|Placebo control.The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
749736|NCT01606202|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
749737|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749738|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749739|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749740|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749741|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749742|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749743|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749744|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749745|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749746|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749747|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749748|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749749|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749750|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749751|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749752|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749753|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749754|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749755|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749756|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749757|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749758|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749759|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749829|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749760|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749761|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749762|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749763|NCT01606202|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749764|NCT01606202|O1|Outcome|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749765|NCT01606202|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749766|NCT01606202|E1|Reported Event|GW-1000-02|Contains THC (27 mg/ml) and CBD (25 mg/ml) delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 48 actuations (THC 130 mg: CBD 120 mg) in 24 hours.
749767|NCT01606189|B1|Baseline|All Study Treatments: GW-1000-02, GW-2000-02 and Placebo|As this was a crossover study design, all patients were to receive all study treatments: GW-1000-02, GW-2000-02 and placebo.
749768|NCT01606189|P6|Participant Flow|GW-2000-02 First, Then Placebo, Then GW-1000-02|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
749769|NCT01606189|P5|Participant Flow|Placebo First, Then GW-2000-02, Then GW-1000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
749770|NCT01606189|P4|Participant Flow|GW-1000-02 First, Then Placebo, Then GW-2000-02|"GW-1000-02 first (14-20 days), then placebo (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
749771|NCT01606189|P3|Participant Flow|Placebo First, Then GW-1000-02, Then GW-2000-02|"Placebo first (14-20 days), then GW-1000-02 (14-20 days), then GW-2000-02 (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
749772|NCT01606189|P2|Participant Flow|GW-2000-02 First, Then GW-1000-02, Then Placebo|"GW-2000-02 first (14-20 days), then GW-1000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
749773|NCT01606189|P1|Participant Flow|GW-1000-02 First, Then GW-2000-02, Then Placebo|"GW-1000-02 first (14-20 days), then GW-2000-02 (14-20 days), then placebo (14-20 days).~Each actuation of GW-1000-02 delivered a dose containing 2.5 mg THC and 2.5 mg CBD, each actuation of GW-2000-02 delivered a dose containing 2.5 mg THC and each actuation of placebo delivered the excipients only. Patients were required to take no more than eight actuations of study medication within each three hour period, and no more than 48 actuations each day (24 hour period)."
749774|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749775|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749776|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749777|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749778|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749779|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749780|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749781|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749782|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749783|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749784|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749785|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749786|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749787|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749788|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749789|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749790|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749791|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749792|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749793|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749794|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749795|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749796|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749797|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749798|NCT01606189|O3|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749799|NCT01606189|O2|Outcome|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749800|NCT01606189|O1|Outcome|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749801|NCT01606189|E3|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 48 actuations in 24 hours.
749802|NCT01606189|E2|Reported Event|GW-2000-02|Each 100 micro litre actuation contains THC (25 mg/ml). The maximum dose allowed was 48 actuations (130 mg THC) per 24 hours.
749803|NCT01606189|E1|Reported Event|GW-1000-02|Each 100 micro litre actuation contains THC (25 mg/ml) and CBD (25mg/ml). The maximum dose allowed was 48 actuations (130 mg THC and 120 mg CBD) per 24 hours.
749804|NCT01606176|B3|Baseline|Total|Total of all reporting groups
749805|NCT01606176|B2|Baseline|Placebo|Placebo control.
749806|NCT01606176|B1|Baseline|GW-1000-02|Active treatment.
749807|NCT01606176|P2|Participant Flow|Placebo|Placebo control. The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
749808|NCT01606176|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.5mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 120 mg : CBD 120 mg).
749809|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749810|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749811|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749812|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749813|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749814|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749815|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749816|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749817|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749818|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749819|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749820|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749821|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749822|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749823|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749824|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749825|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749826|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749827|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749828|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749830|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749831|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749832|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749833|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
760396|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
749834|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749835|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749836|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749837|NCT01606176|O2|Outcome|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749838|NCT01606176|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749839|NCT01606176|E2|Reported Event|Placebo|Each 100 ul actuation contains the excipients. A maximum of 48 actuations was permitted in any 24 hour period.
749840|NCT01606176|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 25 mg THC and 25 mg CBD. A maximum of 48 actuations (120 mg each of THC and CBD) was permitted in any 24 hour period.
749841|NCT01606150|B3|Baseline|Total|Total of all reporting groups
749842|NCT01606150|B2|Baseline|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
749843|NCT01606150|B1|Baseline|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
749844|NCT01606150|P2|Participant Flow|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
749845|NCT01606150|P1|Participant Flow|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
749846|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
749847|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
749848|NCT01606150|O2|Outcome|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
749849|NCT01606150|O1|Outcome|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
749850|NCT01606150|E2|Reported Event|Topical Lidocaine|"LMX-4, 1 gram placed over lumbar puncture needle insertion site 30 minutes prior to the procedure~topical lidocaine: 1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure"
749851|NCT01606150|E1|Reported Event|Subcutaneous Lidocaine|"0.1 ml/kg of 1% Lidocaine~1% lidocaine: 0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure"
749852|NCT01606137|B1|Baseline|GW-1000-02|Active treatment
749853|NCT01606137|P1|Participant Flow|GW-1000-02|Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). The maximum permitted dose of was eight actuations in any three hour period, and 48 actuations in any 24 hour period (THC 130 mg : CBD 120 mg).
749854|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749855|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749856|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749857|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749858|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749859|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749860|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749861|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749862|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749863|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749864|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749865|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749866|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749867|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749868|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
750009|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749869|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749870|NCT01606137|O1|Outcome|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749871|NCT01606137|E1|Reported Event|GW-1000-02|Each 100 ul actuation contains 27 mg THC and 25 mg CBD. A maximum of 48 actuations (130 mg of THC 120 and mg of CBD) was permitted in any 24 hour period.
749872|NCT01606007|B4|Baseline|Total|Total of all reporting groups
749873|NCT01606007|B3|Baseline|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749874|NCT01606007|B2|Baseline|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749875|NCT01606007|B1|Baseline|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749876|NCT01606007|P3|Participant Flow|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749877|NCT01606007|P2|Participant Flow|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749878|NCT01606007|P1|Participant Flow|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749879|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749880|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749881|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749882|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749883|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749884|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749885|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749886|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749887|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749888|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749889|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749956|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749890|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749923|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749891|NCT01606007|O3|Outcome|Arm 3: Saxagliptin+Dapagliflozin+Metformin XR|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749892|NCT01606007|O2|Outcome|Arm 2: Dapagliflozin+Metformin XR+Placebo|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749893|NCT01606007|O1|Outcome|Arm 1: Saxagliptin+Metformin XR+Placebo|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749894|NCT01606007|E3|Reported Event|SAXA + DAPA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148
749895|NCT01606007|E2|Reported Event|DAPA + MET|Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Dapagliflozin Tablets, Oral, 10mg , Once daily, 24 weeks Other Names: BMS512148 Drug: Placebo matching with Saxagliptin Tablets, Oral, 0mg, Once daily, 24 weeks
749896|NCT01606007|E1|Reported Event|SAXA + MET|Drug: Saxagliptin Tablets, Oral, 5mg , Once daily, 24 weeks Other Names: Onglyza Drug: Metformin XR Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks Other Names: Glucophage XR Drug: Placebo matching with Dapagliflozin Tablets, Oral, 0mg, Once daily, 24 weeks
749897|NCT01605942|B3|Baseline|Total|Total of all reporting groups
749898|NCT01605942|B2|Baseline|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749899|NCT01605942|B1|Baseline|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749900|NCT01605942|P2|Participant Flow|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749901|NCT01605942|P1|Participant Flow|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749902|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749903|NCT01605942|O2|Outcome|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749904|NCT01605942|O1|Outcome|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749905|NCT01605942|E2|Reported Event|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749906|NCT01605942|E1|Reported Event|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
749907|NCT01605916|B6|Baseline|Total|Total of all reporting groups
749908|NCT01605916|B5|Baseline|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749909|NCT01605916|B4|Baseline|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749910|NCT01605916|B3|Baseline|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749911|NCT01605916|B2|Baseline|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749912|NCT01605916|B1|Baseline|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749913|NCT01605916|P5|Participant Flow|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749914|NCT01605916|P4|Participant Flow|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749915|NCT01605916|P3|Participant Flow|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749916|NCT01605916|P2|Participant Flow|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749917|NCT01605916|P1|Participant Flow|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749918|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749919|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749920|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749921|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749922|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749924|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749925|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749926|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749927|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749928|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749929|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749930|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749931|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749932|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749933|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749934|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749935|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749936|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749937|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749938|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749939|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749940|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749941|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749942|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749943|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749944|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749945|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749946|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749947|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749948|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749949|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749950|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749951|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749952|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749953|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749954|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749955|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749992|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749957|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749958|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749959|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749960|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749961|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749962|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749963|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749964|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749965|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749966|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749967|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749968|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749969|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749970|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749971|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749972|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749973|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749974|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749975|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749976|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749977|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749978|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749979|NCT01605916|O5|Outcome|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749980|NCT01605916|O4|Outcome|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749981|NCT01605916|O3|Outcome|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749982|NCT01605916|O2|Outcome|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749983|NCT01605916|O1|Outcome|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749984|NCT01605916|E5|Reported Event|Monotherapy Cohort 3 Selumetinib 75 mg|Monotherapy of Selumetinib 75 mg twice a day for Japanese patients with advanced solid malignancies
749985|NCT01605916|E4|Reported Event|Monotherapy Cohort 2 Selumetinib 50 mg|Monotherapy of Selumetinib 50 mg twice a day for Japanese patients with advanced solid malignancies
749986|NCT01605916|E3|Reported Event|Monotherapy Cohort 1 Selumetinib 25 mg|Monotherapy of Selumetinib 25 mg twice a day for Japanese patients with advanced solid malignancies
749987|NCT01605916|E2|Reported Event|Combination Therapy Cohort 2 Selumetinib 25 mg + Doce|Combination therapy of Selumetinib 25 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749988|NCT01605916|E1|Reported Event|Combination Therapy Cohort 1 Selumetinib 75 mg + Doce|Combination therapy of Selumetinib 75 mg twice a day with docetaxel 60 mg/m2 every 21 days for Japanese patients with locally advanced or metastatic non-small cell lung cancer
749989|NCT01605877|B1|Baseline|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
749990|NCT01605877|P1|Participant Flow|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
749991|NCT01605877|O1|Outcome|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749995|NCT01605877|O2|Outcome|SN6AD2, as Measured With VCTS|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749996|NCT01605877|O1|Outcome|SN6AD2, as Measured With CSV-1000|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749997|NCT01605877|O5|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
749998|NCT01605877|O4|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
760402|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
750010|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750011|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750012|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750013|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750014|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750015|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750016|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750017|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750018|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750019|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750020|NCT01605877|O2|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750021|NCT01605877|O1|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750022|NCT01605877|O4|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750023|NCT01605877|O3|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750024|NCT01605877|O2|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750025|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750026|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750027|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750028|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750029|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750030|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750031|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750032|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750033|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750034|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750035|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750036|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750037|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750038|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750039|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750040|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750041|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750042|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750043|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750044|NCT01605877|O6|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750045|NCT01605877|O5|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750046|NCT01605877|O4|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750047|NCT01605877|O3|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750048|NCT01605877|O2|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750049|NCT01605877|O1|Outcome|Preoperative|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2
750050|NCT01605877|E1|Reported Event|SN6AD2|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0], bilateral implantation
750051|NCT01605825|B3|Baseline|Total|Total of all reporting groups
750052|NCT01605825|B2|Baseline|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
750078|NCT01605617|B1|Baseline|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo.
750640|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
750053|NCT01605825|B1|Baseline|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
750054|NCT01605825|P2|Participant Flow|Dalfampridine-ER/Placebo|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
750055|NCT01605825|P1|Participant Flow|Placebo/Dalfampridine-ER|"Subjects will be randomized at day 1 to one of two blinded treatment sequences (A or B) in a 2:1 ratio respectively, according to a randomization created prior to the start of the study:~Period 1 = days 1, 8 and 15. Period 2 = Days 22, 29, and 36~dalfampridine-ER: Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2.~10mg tablets, will be taken orally, twice daily approximately 12 hours apart"
750056|NCT01605825|O2|Outcome|Dalfampridine-ER|
750057|NCT01605825|O1|Outcome|Placebo|
750058|NCT01605825|E2|Reported Event|Dalfampridine-ER|
750059|NCT01605825|E1|Reported Event|Placebo|
750060|NCT01605799|B3|Baseline|Total|Total of all reporting groups
750061|NCT01605799|B2|Baseline|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
750062|NCT01605799|B1|Baseline|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
750063|NCT01605799|P2|Participant Flow|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
750064|NCT01605799|P1|Participant Flow|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
750065|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
750066|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
750067|NCT01605799|O2|Outcome|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
750068|NCT01605799|O1|Outcome|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
750069|NCT01605799|E2|Reported Event|Wait List Control Group|"Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.~Wait list control group: Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment."
750070|NCT01605799|E1|Reported Event|IOK Treatment|"Six to eight week treatment lasting one to 1.5 hours addressing maladaptive cognitions related to killing in war.~IOK Killing Treatment: The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war."
750071|NCT01605669|B1|Baseline|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
750072|NCT01605669|P1|Participant Flow|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
750073|NCT01605669|O2|Outcome|Mean Pressure Gradient <30mmHg (Negative)|
750074|NCT01605669|O1|Outcome|Mean Pressure Gradient >=30mmHg (Positive)|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
750075|NCT01605669|E1|Reported Event|Aortic Stenosis Patients|Patients with varying degrees of aortic stenosis without significant additional valvular disease will be considered eligible for this study.
750076|NCT01605617|B3|Baseline|Total|Total of all reporting groups
750077|NCT01605617|B2|Baseline|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given Percutaneous Tibial Nerve Stimulation (PTNS) + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate.
754194|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
750079|NCT01605617|P2|Participant Flow|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo (12 weeks), washout (4 weeks), PTNS + 4mg of fesoterodine fumarate (12 weeks)
750080|NCT01605617|P1|Participant Flow|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks), Washout (4 weeks), PTNS + placebo (12 weeks)
750081|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
750082|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
750083|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
750084|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
750085|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
750086|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
750087|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
750088|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
750089|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
750090|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
750091|NCT01605617|O2|Outcome|PTNS + Placebo First, Then PTNS + Fesoterodine Fumarate|Participants were to be given PTNS + placebo for 12 weeks followed by 4 weeks of washout followed by 12 weeks of PTNS + 4mg of fesoterodine fumarate
750092|NCT01605617|O1|Outcome|PTNS + Fesoterodine Fumarate First, Then PTNS + Placebo|Participants were to be given PTNS + 4mg of fesoterodine fumarate first for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + placebo
750093|NCT01605617|E4|Reported Event|While on PTNS + Fesoterodine Fumarate Second|Participants were to be given PTNS + 4mg of fesoterodine fumarate (12 weeks)
750094|NCT01605617|E3|Reported Event|While on PTNS + Placebo Second|Participants were to be given PTNS + placebo (12 weeks)
750095|NCT01605617|E2|Reported Event|While on PTNS + Placebo First|Participants were given PTNS + placebo (12 weeks)
750096|NCT01605617|E1|Reported Event|While on PTNS + Fesoterodine Fumarate First|Participants were given PTNS + 4mg of fesoterodine fumarate (12 weeks)
750097|NCT01605552|B3|Baseline|Total|Total of all reporting groups
750098|NCT01605552|B2|Baseline|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
750099|NCT01605552|B1|Baseline|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
750100|NCT01605552|P2|Participant Flow|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
750128|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750129|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750101|NCT01605552|P1|Participant Flow|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
750132|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD will receive 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750133|NCT01605539|O1|Outcome|Control|"Subjects received pills that resembled the Cannabidiol capsule but did not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750658|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
750102|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
750103|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
750104|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
750105|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
750106|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
750107|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
750108|NCT01605552|O2|Outcome|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
750159|NCT01605292|P2|Participant Flow|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750109|NCT01605552|O1|Outcome|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
750110|NCT01605552|E2|Reported Event|Usual Care|"Patients and their primary care providers were informed of the positive depression screen, and follow-up was encouraged.~Usual Care: Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive."
750111|NCT01605552|E1|Reported Event|Beating the Blues (BtB)|"An 8-session, empirically supported, computerized, cognitive-behavioral intervention for depression (www.beatingthebluesus.com)~Beating the Blues (BtB): BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session."
750112|NCT01605539|B3|Baseline|Total|Total of all reporting groups
750113|NCT01605539|B2|Baseline|CBD Group|"The two arms (400 mg and 800 mg of Cannabidiol) were combined for analysis because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750114|NCT01605539|B1|Baseline|Control|"Subjects received pills that resemble the Cannabidiol capsule but did not have its properties.~Control: Subjects receivd a harmless, inactive pill to compare and validate the results of the other arms of the study"
750115|NCT01605539|P3|Participant Flow|CBD 800 Group|Subjects in Arm CBD 800 will receive 800 mg of Cannabidiol in each of the three test sessions
750116|NCT01605539|P2|Participant Flow|CBD 400 Group|"Subjects will receive 400 mg of cannabidiol~Subjects in Arm CBD 400 will receive 400 mg of Cannabidiol in each of the three test sessions"
750117|NCT01605539|P1|Participant Flow|Control|"Subjects will receive pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study"
750118|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750119|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750120|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750121|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750122|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750123|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750124|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750125|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750126|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750127|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750248|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750130|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol. The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750131|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750195|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
760403|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
750134|NCT01605539|O2|Outcome|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Cannabidiol: Subjects in Arm CBD Group received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750135|NCT01605539|O1|Outcome|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750136|NCT01605539|E2|Reported Event|CBD Group|"Subjects received 400 mg or 800mg of cannabidiol.The two arms (400 mg and 800 mg CBD groups) were combined for analysis as CPD Group because the sample size was too small and dividing the two arms would not have yielded a meaningful analysis.~Subjects in Arm CBD received 400 mg or 800mg of Cannabidiol in each of the three test sessions"
750137|NCT01605539|E1|Reported Event|Control|"Subjects received pills that resemble the Cannabidiol capsule but do not have have its properties.~Control: Subjects received a harmless, inactive pill to compare and validate the results of the other arms of the study"
750138|NCT01605461|B1|Baseline|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750139|NCT01605461|P1|Participant Flow|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750140|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750141|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750142|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750143|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750144|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750145|NCT01605461|O1|Outcome|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750146|NCT01605461|E1|Reported Event|All Participants|Participants received a single oral dose of 800 mg deleobuvir (BI 207127) sodium salt (NA) powder dissolved in a 20 mL solution of compendial grade sodium lauryl sulfate, tromethamine, polyethylene glycol 400, and water.
750147|NCT01605370|B3|Baseline|Total|Total of all reporting groups
750148|NCT01605370|B2|Baseline|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
750149|NCT01605370|B1|Baseline|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
750150|NCT01605370|P2|Participant Flow|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
750151|NCT01605370|P1|Participant Flow|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
750152|NCT01605370|O2|Outcome|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
750153|NCT01605370|O1|Outcome|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
750154|NCT01605370|E2|Reported Event|Metoprolol Succinate|"Subjects randomized to this arm will receive metoprolol succinate 50 mg once daily.~Metoprolol succinate: Metoprolol succinate 50 mg once daily"
750155|NCT01605370|E1|Reported Event|Nebivolol|"Subjects randomized to this arm will receive Nebivolol 2.5 mg once daily.~Nebivolol: Nebivolol 2.5 mg once daily"
750156|NCT01605292|B3|Baseline|Total|Total of all reporting groups
750157|NCT01605292|B2|Baseline|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750158|NCT01605292|B1|Baseline|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750641|NCT01603043|O2|Outcome|Sham Injection|1 mock injection per month for 12 months
750160|NCT01605292|P1|Participant Flow|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750161|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750162|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750163|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750164|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750659|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
750165|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750166|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750167|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750168|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750169|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750170|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750171|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750172|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750173|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750174|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750175|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750176|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750177|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750178|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750179|NCT01605292|O2|Outcome|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750180|NCT01605292|O1|Outcome|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750181|NCT01605292|E2|Reported Event|Ultrasound|"Real-time ultrasound guidance to facilitate needle cannulation of artery.~Ultrasound guidance: Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted."
750182|NCT01605292|E1|Reported Event|Palpation|"Manual palpation of radial pulse, as sole guide to needle cannulation.~Palpation: Manual palpation for localizing radial artery for inserting needle."
750183|NCT01604941|B3|Baseline|Total|Total of all reporting groups
750184|NCT01604941|B2|Baseline|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750185|NCT01604941|B1|Baseline|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750186|NCT01604941|P6|Participant Flow|SPD602 75mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 75 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
750187|NCT01604941|P5|Participant Flow|SPD602 50mg/kg/Day Once Daily Dosing (QD)|Participants were randomly assigned to 50 mg/kg/day oral QD dosing and continued QD dosing until the end of study (24 weeks) or early discontinuation.
750188|NCT01604941|P4|Participant Flow|SPD602 75mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
750189|NCT01604941|P3|Participant Flow|SPD602 50mg/kg/Day Once (QD) Then Twice Daily Dosing (BID)|Participants were randomly assigned to QD dosing then re-enrolled to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
750190|NCT01604941|P2|Participant Flow|SPD602 75mg/kg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 75 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
754195|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
750191|NCT01604941|P1|Participant Flow|SPD602 50mg/mg/Day Twice Daily Dosing (BID)|Participants were randomly assigned to 50 mg/kg/day oral BID dosing and continued BID dosing until the end of study (24 weeks) or early discontinuation.
750192|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750193|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750194|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750660|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
750196|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750197|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750198|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750199|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750200|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750201|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750202|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750203|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750204|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750205|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750206|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750207|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750208|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750209|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750210|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750211|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750212|NCT01604941|O2|Outcome|All Participants With BID Dosing|Of the 21 participants randomly assigned to BID dosing (including re-enrolled participants), 10 were excluded from the Full Analysis Set. Data for this arm were analyzed to verify that the protocol, as finally amended, was not impacted by using only the lower dose.
750213|NCT01604941|O1|Outcome|SPD602 50 mg/kg/d|Participants received SPD602 50mg/kg/day oral dosing either twice daily (BID) or once daily (QD), then BID.
750214|NCT01604941|E2|Reported Event|SPD602 75mg/kg/Day|Participants received SPD602 75mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
750215|NCT01604941|E1|Reported Event|SPD602 50mg/kg/Day|Participants received SPD602 50mg/kg/day oral dosing BID either as originally randomized or as a re-enrolled participant.
750216|NCT01604850|B3|Baseline|Total|Total of all reporting groups
750217|NCT01604850|B2|Baseline|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750218|NCT01604850|B1|Baseline|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750219|NCT01604850|P2|Participant Flow|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750249|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750642|NCT01603043|O1|Outcome|AL-78898A|1 intravitreal injection per month for up to 12 months
750220|NCT01604850|P1|Participant Flow|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750221|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750222|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750223|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750224|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750225|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750226|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750227|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750228|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750229|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750230|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750231|NCT01604850|O2|Outcome|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750232|NCT01604850|O1|Outcome|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750233|NCT01604850|E2|Reported Event|SOF+RBV|"Participants were randomized to receive sofosbuvir+RBV for 16 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets."
750234|NCT01604850|E1|Reported Event|SOF+RBV+Placebo|"Participants were randomized to receive sofosbuvir+RBV for 12 weeks, followed by placebo to match sofosbuvir plus placebo to match RBV for 4 weeks.~Sofosbuvir (400 mg) was administered as an oral tablet and RBV (1000-1200 mg) as 200 mg oral tablets. Placebo to match sofosbuvir and placebo to match RBV were also administered as oral tablets."
750235|NCT01604772|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
750236|NCT01604772|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
750237|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
750238|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
750239|NCT01604772|O1|Outcome|Treatment (Akt Inhibitor MK2206)|
750240|NCT01604772|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly for 4 weeks. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: 150 mg given PO"
750241|NCT01604278|B3|Baseline|Total|Total of all reporting groups
750242|NCT01604278|B2|Baseline|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750243|NCT01604278|B1|Baseline|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750244|NCT01604278|P2|Participant Flow|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750245|NCT01604278|P1|Participant Flow|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750246|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750247|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750250|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750251|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750252|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750253|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750254|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750255|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750256|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750257|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750258|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750259|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750260|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750261|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750262|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750263|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750264|NCT01604278|O2|Outcome|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750265|NCT01604278|O1|Outcome|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750266|NCT01604278|E2|Reported Event|Placebo to NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via SDDPI plus placebo to NVA237 delivered via SDDPI
750267|NCT01604278|E1|Reported Event|NVA237 + Indacaterol|Participants received Indacaterol 150 ug once daily delivered via single dose dry powder inhaler (SDDPI) plus NVA237 50 ug once daily delivered via SDDPI
750268|NCT01604265|B3|Baseline|Total|Total of all reporting groups
750269|NCT01604265|B2|Baseline|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750270|NCT01604265|B1|Baseline|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750271|NCT01604265|P2|Participant Flow|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750272|NCT01604265|P1|Participant Flow|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750273|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750274|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750275|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750276|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750277|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750278|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750279|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750280|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750281|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750282|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750283|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750284|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750285|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750286|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750287|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750288|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750289|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750290|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750291|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750292|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750293|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750294|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750295|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750296|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750297|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750298|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750299|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750300|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750301|NCT01604265|O2|Outcome|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750302|NCT01604265|O1|Outcome|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750303|NCT01604265|E2|Reported Event|Placebo|Each actuation of placebo delivered the excipients and colourants only. The maximum daily exposure was set at 48 actuations per 24 hours.
750304|NCT01604265|E1|Reported Event|Sativex|Each actuation contains 2.5 mg THC and 2.5 mg CBD, delivered through a pump action oromucosal spray. The maximum daily exposure was set at 48 actuations per 24 hours.
750305|NCT01604122|B3|Baseline|Total|Total of all reporting groups
750306|NCT01604122|B2|Baseline|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750307|NCT01604122|B1|Baseline|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750308|NCT01604122|P2|Participant Flow|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750309|NCT01604122|P1|Participant Flow|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750310|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750311|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750312|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750313|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750314|NCT01604122|O1|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750315|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750316|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750317|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750643|NCT01603043|E2|Reported Event|Sham Injection|1 mock injection per month for 12 months
750318|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750319|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750320|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750321|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750322|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750323|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750324|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750325|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750326|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750327|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750328|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750329|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750330|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750331|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750332|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750333|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750334|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750335|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750336|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750337|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750338|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750339|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750340|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750341|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750342|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750644|NCT01603043|E1|Reported Event|AL-78898A|1 intravitreal injection per month for up to 12 months
750343|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750344|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750345|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750346|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750347|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750348|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750349|NCT01604122|O2|Outcome|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750350|NCT01604122|O1|Outcome|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750351|NCT01604122|E2|Reported Event|Caregivers|Caregivers were those participants who provided support and care to the participants diagnosed with ATTR (TTR-FAP and TTR-CM) and completed the caregiver survey, regardless of whether they themselves were diagnosed with ATTR or not.
750352|NCT01604122|E1|Reported Event|Participants Diagnosed With ATTR|Participants diagnosed with transthyretin amyloidosis (ATTR) with two phenotypes: familial amyloid polyneuropathy (TTR-FAP) and cardiac amyloidosis (TTR-CM) were included in this non-interventional study to complete the one time survey.
750353|NCT01604109|B3|Baseline|Total|Total of all reporting groups
750354|NCT01604109|B2|Baseline|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
750355|NCT01604109|B1|Baseline|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
750356|NCT01604109|P2|Participant Flow|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
750357|NCT01604109|P1|Participant Flow|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
750358|NCT01604109|O2|Outcome|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
750359|NCT01604109|O1|Outcome|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
750360|NCT01604109|E2|Reported Event|Placebo Control Paste|"the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate~the paste without CPP-ACP : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch."
750361|NCT01604109|E1|Reported Event|Tooth Mousse|"10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste~10 % w/v CPP-ACP paste : Apply once a day at school by school teacher, following fluoride toothbrushing after lunch"
750362|NCT01603940|B3|Baseline|Total|Total of all reporting groups
750363|NCT01603940|B2|Baseline|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750364|NCT01603940|B1|Baseline|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750365|NCT01603940|P2|Participant Flow|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750366|NCT01603940|P1|Participant Flow|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750367|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750368|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750369|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750370|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750371|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750645|NCT01602744|B3|Baseline|Total|Total of all reporting groups
754196|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
750372|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750373|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750374|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750375|NCT01603940|O2|Outcome|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750376|NCT01603940|O1|Outcome|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750377|NCT01603940|E2|Reported Event|Benazepril|"This group will receive 20 mg of benazepril per day. Amlodipine will be maintained.~Benazepril: Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks."
750378|NCT01603940|E1|Reported Event|Losartan|"This group will receive 100 mg of losartan per day. Amlodipine will be maintained.~Losartan: Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks."
750379|NCT01603875|B4|Baseline|Total|Total of all reporting groups
750380|NCT01603875|B3|Baseline|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750381|NCT01603875|B2|Baseline|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750382|NCT01603875|B1|Baseline|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750383|NCT01603875|P3|Participant Flow|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750384|NCT01603875|P2|Participant Flow|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750385|NCT01603875|P1|Participant Flow|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750386|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750387|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750388|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750389|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750390|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750391|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750392|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750393|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750394|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750395|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750396|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750397|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750398|NCT01603875|O3|Outcome|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750399|NCT01603875|O2|Outcome|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750400|NCT01603875|O1|Outcome|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750646|NCT01602744|B2|Baseline|Intervention STOPP/START|Screening medications with STOPP/START critera
750401|NCT01603875|E3|Reported Event|PrEP and Simulated PEP With New CPRV by Intradermal Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750402|NCT01603875|E2|Reported Event|PrEP and Simulated PEP With New CPRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750403|NCT01603875|E1|Reported Event|PrEP and Simulated PEP With PVRV by Intramuscular Route|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).: new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
750435|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750436|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750404|NCT01603459|B1|Baseline|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
750405|NCT01603459|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
750406|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750407|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750408|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750409|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750410|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750411|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750412|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750413|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750414|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750415|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750416|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750417|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750418|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750419|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750420|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750421|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750422|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750423|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750424|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750425|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750426|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750427|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750428|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750429|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750430|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750647|NCT01602744|B1|Baseline|Controll|The medications in this arm will not be screened.
750431|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750432|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750433|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750434|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750437|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750438|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750439|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750440|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750441|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750442|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750443|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750444|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750445|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750446|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750447|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750448|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750449|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750450|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750451|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750452|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750453|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750454|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750455|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750456|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750457|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750458|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750459|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750460|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750461|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750462|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750463|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750464|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750465|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750466|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750467|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750468|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750469|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750470|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750471|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750472|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750473|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750474|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750475|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750476|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750477|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750478|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750479|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750480|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750481|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750482|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750483|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750484|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750485|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750486|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750487|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750488|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750489|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750490|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750491|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750492|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750493|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750494|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750495|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750496|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750497|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750498|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750499|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750500|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750501|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750502|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750503|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750504|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750505|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750506|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750507|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750508|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to End of Cycle 3 Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750509|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 3 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750510|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Timeframe 1|Time frame 1 is from Study Baseline to Cycle 2 Baseline. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750511|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 3|Time frame 3 is from Study Baseline to Cycle 3 Control Visit. Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750512|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 2|Time frame 2 is from Study Baseline to Cycle 2 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750513|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Time Frame 1|Time frame 1 is from Study Baseline to Cycle 1 Control Visit. Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750514|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750515|NCT01603459|O2|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750516|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750517|NCT01603459|O6|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 3 Control Visit 1|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750518|NCT01603459|O5|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 3 Baseline Visit|Subjects to receive IncobotulinumtoxinA total body dose of 800 units Intramuscular injection.
750519|NCT01603459|O4|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 2 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750520|NCT01603459|O3|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 2 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 600 units Intramuscular injection.
750521|NCT01603459|O2|Outcome|IncobotulinumtoxinA(Xeomin): Injection Cycle 1 Control Visit 1|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750522|NCT01603459|O1|Outcome|IncobotulinumtoxinA (Xeomin): Injection Cycle 1 Baseline Visit|Subjects to receive IncobotulinumtoxinA fixed total body dose of 400 units Intramuscular injection.
750523|NCT01603459|E1|Reported Event|IncobotulinumtoxinA (Xeomin) (up to 800 Units)|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA: Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: Intramuscular injection."
750524|NCT01603420|B3|Baseline|Total|Total of all reporting groups
750525|NCT01603420|B2|Baseline|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750526|NCT01603420|B1|Baseline|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750527|NCT01603420|P2|Participant Flow|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750528|NCT01603420|P1|Participant Flow|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750529|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750547|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750530|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750531|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750597|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
760404|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
750532|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750533|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750534|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750535|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750536|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750537|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750538|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750539|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750540|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750541|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750542|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750543|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750544|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750545|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750546|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750593|NCT01603082|P2|Participant Flow|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750548|NCT01603420|O1|Outcome|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750566|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750657|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
750549|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750550|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750551|NCT01603420|O2|Outcome|Radiation + Chemo + 6mo Luteinizing Hormone-releasing Hormone|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750552|NCT01603420|O1|Outcome|Radiation + 24mo Luteinizing Hormone-releasing Hormone (LHRH)|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~Luteinizing hormone-releasing hormone (LHRH): Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal Radiation Therapy (RT): 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750553|NCT01603420|E2|Reported Event|Radiation + Chemo + 6mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + Chemotherapy: Docetaxel 20mg/m2 x every 7 days x 8 weeks followed by 6 months LHRH (androgen suppression).~Docetaxel: Docetaxel 20mg/m2 IV every 7 days x 8 weeks.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750554|NCT01603420|E1|Reported Event|Radiation + 24mo LHRH|"Conformal RT 79.2 Gy(RBE) total dose + 24 months LHRH agonist (androgen suppression).~LHRH: Androgen suppression therapy using LHRH agonists such as leuprolide, goserelin, buserelin, triptorelin.~Conformal RT: 1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy)."
750555|NCT01603394|B1|Baseline|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750556|NCT01603394|P1|Participant Flow|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750557|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750558|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750559|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750560|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750561|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750562|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750563|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750564|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750592|NCT01603082|B1|Baseline|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750565|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750567|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750568|NCT01603394|O1|Outcome|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750569|NCT01603394|E1|Reported Event|Pregabalin (300-600 mg/Day; 150 mg/Day Starting Dose)|During the first week of treatment, participants received the starting dose of pregabalin of 150 mg/day Participants were then optimized to a dose of 300, 450 or 600 mg/day pregabalin based on efficacy and tolerability at each weekly visit: V3 (Week 1), V4 (Week 2), V5 (Week 3) and V6 (Week 4).
750570|NCT01603277|B3|Baseline|Total|Total of all reporting groups
750571|NCT01603277|B2|Baseline|Normal Saline|Placebo: Normal Saline
750572|NCT01603277|B1|Baseline|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
750573|NCT01603277|P2|Participant Flow|Normal Saline|Placebo: Normal Saline
750574|NCT01603277|P1|Participant Flow|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
750575|NCT01603277|O2|Outcome|Normal Saline|Placebo: Normal Saline
750576|NCT01603277|O1|Outcome|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
750577|NCT01603277|E2|Reported Event|Normal Saline|Placebo: Normal Saline
750578|NCT01603277|E1|Reported Event|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg: Anti-GM-CSF Monoclonal Antibody 400mg
750579|NCT01603121|B1|Baseline|All Study Participants|Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.
750580|NCT01603121|P2|Participant Flow|Lisofylline Intravenous First, Then Lisofylline Subcutaneous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750581|NCT01603121|P1|Participant Flow|Lisofylline Subcutaneous First, Then Lisofylline Intravenous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750582|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750583|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750584|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750585|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750586|NCT01603121|O2|Outcome|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750587|NCT01603121|O1|Outcome|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750588|NCT01603121|E2|Reported Event|Lisofylline Intravenous|"Lisofylline 9 mg/kg as a continuous intravenous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750589|NCT01603121|E1|Reported Event|Lisofylline Subcutaneous|"Lisofylline 12mg/kg as a continuous subcutaneous infusion over a 10 hours period~Lisofylline: Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart."
750590|NCT01603082|B3|Baseline|Total|Total of all reporting groups
750591|NCT01603082|B2|Baseline|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750594|NCT01603082|P1|Participant Flow|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750595|NCT01603082|O2|Outcome|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750596|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750598|NCT01603082|O1|Outcome|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750599|NCT01603082|E2|Reported Event|Clopidogrel|600 mg loading dose after diagnostic angiography, with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750600|NCT01603082|E1|Reported Event|Ticagrelor|180 mg loading dose after diagnostic angiography, followed by 90 mg after 12 hours (± 1 hour), with concomitant acetylysalicylic acid (160 mg to 500mg loading dose followed by a daily maintenance dose of 75 mg to 100 mg)
750601|NCT01603056|B3|Baseline|Total|Total of all reporting groups
750602|NCT01603056|B2|Baseline|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750603|NCT01603056|B1|Baseline|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750604|NCT01603056|P2|Participant Flow|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750605|NCT01603056|P1|Participant Flow|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750606|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750607|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750608|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750609|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750610|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750611|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750612|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750613|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750614|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750615|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750616|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750617|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750618|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750619|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750620|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750621|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750622|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750623|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750624|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750625|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750626|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750627|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750628|NCT01603056|O2|Outcome|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750629|NCT01603056|O1|Outcome|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750630|NCT01603056|E2|Reported Event|Placebo|Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750631|NCT01603056|E1|Reported Event|PANGRAMIN SLIT HDM MIX|Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
750632|NCT01603043|B3|Baseline|Total|Total of all reporting groups
750633|NCT01603043|B2|Baseline|Sham Injection|1 mock injection per month for 12 months
750634|NCT01603043|B1|Baseline|AL-78898A|1 intravitreal injection per month for up to 12 months
750635|NCT01603043|P2|Participant Flow|Sham Injection|1 mock injection per month for 12 months
750636|NCT01603043|P1|Participant Flow|AL-78898A|1 intravitreal injection per month for up to 12 months
750648|NCT01602744|P2|Participant Flow|Intervention STOPP/START|Screening medications with STOPP/START critera
750649|NCT01602744|P1|Participant Flow|Controll|The medications in this arm will not be screened.
750650|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
750651|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
750652|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
750653|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
750654|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
750655|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
750656|NCT01602744|O2|Outcome|Intervention STOPP/START|Screening medications with STOPP/START critera
750661|NCT01602744|O1|Outcome|Controll|The medications in this arm will not be screened.
750662|NCT01602744|E2|Reported Event|Intervention STOPP/START|Screening medications with STOPP/START critera
750663|NCT01602744|E1|Reported Event|Controll|The medications in this arm will not be screened.
750664|NCT01602731|B1|Baseline|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
750665|NCT01602731|P1|Participant Flow|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
750666|NCT01602731|O1|Outcome|Automated Medication Dispensing Device|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
750667|NCT01602731|O2|Outcome|After AMDD|Adherence was measured with the use of the AMDD as a 30-day pill count
750668|NCT01602731|O1|Outcome|Before AMDD|Adherence was measured by 30-day pill count before the use of AMDD
750669|NCT01602731|E1|Reported Event|AMDD|"Subjects with <88% medication adherence, determined by 30-day pillcount, will proceed to AMDD portion of study~Automated Medication Dispensing Device: A pre-filled medication dispensing machine with a safety phone call if doses are missed"
750670|NCT01602562|B3|Baseline|Total|Total of all reporting groups
750671|NCT01602562|B2|Baseline|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750672|NCT01602562|B1|Baseline|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750673|NCT01602562|P2|Participant Flow|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kilogram (kg) body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750674|NCT01602562|P1|Participant Flow|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a valaciclovir hydrochloride (VACV) tablet containing 500 milligrams (mg) of valaciclovir orally twice daily for 43 days, from 7 days before hematopoietic stem cell transplantation (HSCT) to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750675|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750676|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750677|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750678|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
751240|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
750679|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750680|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750696|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750767|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750681|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750682|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750683|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750684|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750685|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750686|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750687|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750688|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750689|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750690|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750691|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750692|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750693|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
751241|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
750694|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750695|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and & <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750697|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750698|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750699|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750700|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750701|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750702|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750703|NCT01602562|O2|Outcome|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750704|NCT01602562|O1|Outcome|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750705|NCT01602562|E2|Reported Event|Pediatric Participants: VACV 500 mg Granules/Tablets|Pediatric participants (between 1 and <16 years of age) received VACV granules orally at a dose of 25 mg/kg body weight twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. The maximum dose per treatment was limited to 500 mg. Participants weighing 40 kg or more could have been given a VACV tablet (containing 500 mg of valaciclovir) orally twice daily. VACV granules were administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750706|NCT01602562|E1|Reported Event|Adult Participants: VACV 500 mg Tablet|Adult participants (between 16 and 65 years of age) received a VACV tablet containing 500 mg of valaciclovir orally twice daily for 43 days, from 7 days before HSCT to 35 days after HSCT. A VACV tablet was administered once daily on Day -7 (7 days before HSCT) and on Day 35 (35 days after the final administration of HSCT).
750707|NCT01602549|B3|Baseline|Total|Total of all reporting groups
750708|NCT01602549|B2|Baseline|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750709|NCT01602549|B1|Baseline|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750710|NCT01602549|P2|Participant Flow|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750711|NCT01602549|P1|Participant Flow|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750712|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750713|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750714|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750715|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750716|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750717|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750718|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750719|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750720|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750721|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750722|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
751258|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
750723|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750724|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750725|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750726|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750727|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750728|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750729|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750730|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750731|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750732|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750733|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750734|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750735|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750736|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750737|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750738|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750739|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750740|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750741|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750742|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750743|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750744|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750745|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750746|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750747|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750748|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750749|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750750|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750751|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750752|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750753|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750754|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750755|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750756|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750757|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750758|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
751242|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
750759|NCT01602549|O3|Outcome|GSK962040 Total|Participants received GSK962040 50 milligrams (mg) (except for one participant who received GSK962040 125 mg) administered orally once daily for 7 to 9 days.
750760|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750761|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750762|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750763|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750764|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750765|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750766|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750768|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750769|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750770|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750771|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750772|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750773|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750774|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750775|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750776|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750777|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750778|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750779|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750780|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750781|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750782|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750783|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750784|NCT01602549|O2|Outcome|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750785|NCT01602549|O1|Outcome|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750786|NCT01602549|E3|Reported Event|GSK962040 125 mg|Participants received GSK962040 125 milligrams (mg) administered orally once daily for 7 to 9 days.
750787|NCT01602549|E2|Reported Event|GSK962040 50 mg|Participants received GSK962040 50 milligrams (mg) administered orally once daily for 7 to 9 days.
750788|NCT01602549|E1|Reported Event|Placebo|Participants received placebo administered orally once daily for 7 to 9 days.
750789|NCT01602510|B1|Baseline|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200 mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
750790|NCT01602510|P3|Participant Flow|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750791|NCT01602510|P2|Participant Flow|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750792|NCT01602510|P1|Participant Flow|Open Label Lamotrigine 200 mg/Day|Participants (Par.) received lamotrigine escalated to a target dose of lamotrigine 200mg/day monotherapy for 6 weeks to 16 weeks. If needed, concomitant psychotropic medications were permitted during this phase however medications were discontinued at least 1 week before entering into the double-blind phase.
750793|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750794|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750795|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
751243|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
750796|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750797|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750798|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
751259|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
750799|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750800|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750801|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750802|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750803|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750804|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750805|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750806|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750807|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750808|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750809|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750810|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750811|NCT01602510|O2|Outcome|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750812|NCT01602510|O1|Outcome|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750916|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750813|NCT01602510|E2|Reported Event|Randomized Lamotrigine 200 mg/Day|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a CGI-S score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received lamotrigine 200 mg/day for 36 weeks.
750814|NCT01602510|E1|Reported Event|Randomized Placebo|Participants who reached a stable dose of lamotrigine and met response criteria, defined as a Clinical Global Impression of Severity (CGI-S) score <= 3 maintained for at least 4 continuous weeks and lamotrigine 200 mg/day monotherapy maintained for at least 1 week during open label phase, were enrolled in the double-blind phase of the study. Participants received placebo for 36 weeks.
750815|NCT01602484|B3|Baseline|Total|Total of all reporting groups
750816|NCT01602484|B2|Baseline|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
750817|NCT01602484|B1|Baseline|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
751260|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
750818|NCT01602484|P2|Participant Flow|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
750819|NCT01602484|P1|Participant Flow|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
750820|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
750821|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
750822|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
750823|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
750824|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
750825|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
750826|NCT01602484|O2|Outcome|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
750827|NCT01602484|O1|Outcome|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
750828|NCT01602484|E2|Reported Event|Bulk Supplies|Group of post-op patients who have splint applied from bulk supplies
750829|NCT01602484|E1|Reported Event|Splint Pack|Group of post-op patients who have splint applied from prepared Plaster-of-Paris splint pack
750830|NCT01602471|B1|Baseline|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
750831|NCT01602471|P1|Participant Flow|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
750832|NCT01602471|O1|Outcome|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
750833|NCT01602471|E1|Reported Event|[F-18]RDG-K5|[F-18]RDG-K5 was administred and PET scan performed
750834|NCT01602380|B3|Baseline|Total|Total of all reporting groups
750835|NCT01602380|B2|Baseline|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750836|NCT01602380|B1|Baseline|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750837|NCT01602380|P2|Participant Flow|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750838|NCT01602380|P1|Participant Flow|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750839|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750840|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750841|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750842|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750860|NCT01602341|B2|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750843|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750844|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750884|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750845|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750846|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750847|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750848|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750849|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750850|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750851|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750852|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750853|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750854|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750855|NCT01602380|O2|Outcome|Anastrozole 1 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750856|NCT01602380|O1|Outcome|Fulvestrant 500 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750857|NCT01602380|E2|Reported Event|Anastrozole 1 mg|Patients received fulvestrant (Faslodex™) 500 mg, administered as two 5 mL intramuscular injections, 1 in each buttock, at each visit on Days 0, 14 (±3), 28 (±3) and every 28 (±3) days thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive fulvestrant, also received placebo to match the anastrozole schedule (tablets, once daily).
750858|NCT01602380|E1|Reported Event|Fulvestrant 500 mg|Patients received anastrozole (Arimidex™), administered orally as a single tablet at a dose of 1 mg/day from randomisation on Day 0 and once daily thereafter. In order to support the double-blind, double-dummy design of the trial, each patient randomised to receive anastrozole also received placebo to match the fulvestrant schedule (injections on Days 0, 14 [±3], 28 [±3] and every 28 [±3] days thereafter).
750859|NCT01602341|B3|Baseline|Total|Total of all reporting groups
750915|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
750861|NCT01602341|B1|Baseline|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750862|NCT01602341|P2|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750923|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
750863|NCT01602341|P1|Participant Flow|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate atopic dermatitis (AD), once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750864|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750865|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750866|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750867|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750868|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750869|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750870|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750871|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750872|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750873|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750874|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750875|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750876|NCT01602341|O2|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750877|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750878|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750879|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750880|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750881|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750882|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750883|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
751261|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
750885|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750886|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750887|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750888|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750889|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750890|NCT01602341|O4|Outcome|AN2728 Ointment 2 Percent, Twice Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750891|NCT01602341|O3|Outcome|AN2728 Ointment 0.5 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750892|NCT01602341|O2|Outcome|AN2728 Ointment 2 Percent, Once Daily|AN2728 topical ointment, 2 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750893|NCT01602341|O1|Outcome|AN2728 Ointment 0.5 Percent, Once Daily|AN2728 topical ointment, 0.5 percent was applied to 1 anatomically distinct treatment-targeted lesion within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750894|NCT01602341|E2|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Twice Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, twice daily from Day 1 up to Day 28 and applied only once on Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750895|NCT01602341|E1|Reported Event|AN2728 Ointment 0.5 Percent + 2 Percent, Once Daily|AN2728 topical ointment, 0.5 percent and 2 percent was applied to 2 anatomically distinct treatment-targeted lesions within each participant with mild to moderate AD, once daily from Day 1 up to Day 29. Lesions were identified at Baseline (Day 1) by investigator.
750896|NCT01602198|B3|Baseline|Total|Total of all reporting groups
750897|NCT01602198|B2|Baseline|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
750898|NCT01602198|B1|Baseline|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
750899|NCT01602198|P2|Participant Flow|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
750900|NCT01602198|P1|Participant Flow|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
750901|NCT01602198|O2|Outcome|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
750902|NCT01602198|O1|Outcome|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
750903|NCT01602198|E2|Reported Event|Placebo Transdermal Patch|"Placebo transdermal patch~Placebo patch: Placebo patch 1/day for 6 months"
750904|NCT01602198|E1|Reported Event|Exelon Transdermal Patch|"Exelon [rivastigmine] transdermal patch~Exelon [rivastigmine] transdermal patch: Exelon patch 1/day for six months"
750905|NCT01602016|B1|Baseline|All Participants|
750906|NCT01602016|P1|Participant Flow|All Participants|
750907|NCT01602016|O1|Outcome|All Participants|
750908|NCT01602016|E1|Reported Event|All Participants|
750909|NCT01601977|B1|Baseline|All Participants|Single arm crossover nonrandomised study
750910|NCT01601977|P1|Participant Flow|All Study Participants|Initial study period in usual care then switched to novel ventilation with AVAPS-AE algorithm
750911|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
750912|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750913|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
750914|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750917|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
750918|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750919|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
750920|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750921|NCT01601977|O2|Outcome|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care~crossover trial, as per intervention"
750922|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750924|NCT01601977|O1|Outcome|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750925|NCT01601977|E2|Reported Event|Usual Care|"Usual care including non-invasive ventilation~Usual care: usual care"
750926|NCT01601977|E1|Reported Event|Intervention|"Single arm, open labelled study~Omnilab - AVAPS AE algorithm: Nocturnal NIV via Omnilab device using the AVAPS AE algorithm"
750927|NCT01601821|B3|Baseline|Total|Total of all reporting groups
750928|NCT01601821|B2|Baseline|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750929|NCT01601821|B1|Baseline|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750930|NCT01601821|P2|Participant Flow|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750931|NCT01601821|P1|Participant Flow|CsA+Rapamune+CS|Month 0-3: rapamune 6 milligram (mg) tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 nanogram per milliliter (ng/mL) in combination with cyclosporine (CsA) tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, mycophenolate mofetil (MMF) tablet orally at a dose of 1-1.5 grams per day (g/day) and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received corticosteroids (CS) tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750932|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750933|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750934|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750935|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750936|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750937|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750984|NCT01601691|E1|Reported Event|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
750938|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750939|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
751069|NCT01600703|B1|Baseline|All Study Participants|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
750940|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750941|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750942|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750943|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750944|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750945|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750946|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750947|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750948|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750949|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750950|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750951|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750952|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750953|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750954|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750955|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750956|NCT01601821|O2|Outcome|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750957|NCT01601821|O1|Outcome|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750958|NCT01601821|E2|Reported Event|CsA+MMF+CS|Month 0-5: CsA tablets orally to achieve a trough level of 150-300 ng/mL. Month 6-12: CsA tablets orally to achieve a trough level of 100-200 ng/mL. Participants also received MMF tablet orally at a dose of 2 g/day and CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750959|NCT01601821|E1|Reported Event|CsA+Rapamune+CS|Month 0-3: rapamune 6 mg tablet orally once as a loading dose within 48 hours of transplantation, followed by rapamune 2 mg tablet orally once daily as a maintenance dose to achieve a target trough level of 8-15 ng/mL in combination with CsA tablets orally to achieve a trough level of 150-250 ng/mL. Month 4-6: CsA was withdrawn abruptly, MMF tablet orally at a dose of 1-1.5 g/day and rapamune dose adjusted to achieve a target trough level of 10-15 ng/mL. Month 7-12: rapamune dose adjusted to achieve a target trough level of 8-12 ng/mL, MMF tablet orally at a dose of 1-1.5 g/day. Participants also received CS tablets orally as per local practice with a minimum daily dose of 5 mg over 12 months.
750960|NCT01601782|B1|Baseline|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
750961|NCT01601782|P1|Participant Flow|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
750962|NCT01601782|O1|Outcome|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
750963|NCT01601782|E1|Reported Event|Volume Imaging Scan|"New type of ultrasound scan using General Electric US scanner, Model is a GE Logiq E9.~Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name). : The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to image the muscle and tendon injuries.~Ultrasound Scan : Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician."
750964|NCT01601704|B3|Baseline|Total|Total of all reporting groups
750965|NCT01601704|B2|Baseline|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
751213|NCT01600014|O4|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
750966|NCT01601704|B1|Baseline|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750967|NCT01601704|P2|Participant Flow|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
751067|NCT01600716|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. Median duration of exposure is 15.2 weeks.
750968|NCT01601704|P1|Participant Flow|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750969|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750970|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750971|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750972|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750973|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750974|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750975|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750976|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750977|NCT01601704|O2|Outcome|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750978|NCT01601704|O1|Outcome|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750979|NCT01601704|E2|Reported Event|Placebo|"Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750980|NCT01601704|E1|Reported Event|NB32|"NB32: Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.~Weight Management Program: A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools."
750981|NCT01601691|B1|Baseline|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
750982|NCT01601691|P1|Participant Flow|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
750983|NCT01601691|O1|Outcome|Spacer|"Subjects with spacer injection~DuraSeal: Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate"
751244|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
750985|NCT01601470|B1|Baseline|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750986|NCT01601470|P1|Participant Flow|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750987|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750988|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750989|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750990|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750991|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750992|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750993|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750994|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750995|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750996|NCT01601470|O1|Outcome|Period 1:Sildenafil;Period 2:LCZ696;Period 3:LCZ696+Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by a wash out on Day 2. In Period 2 (study Days 3-7), participants received LCZ696 once daily. In Period 3, on study Day 8, participants received LCZ696, co-administered at the same time with a single dose of sildenafil.
750997|NCT01601470|E3|Reported Event|Period 3: LCZ696 + Sildenafil|In Period 3, on study Day 8, participants received LCZ696 , co-administered at the same time with a single dose of sildenafil.
750998|NCT01601470|E2|Reported Event|Period 2: LCZ696|In Period 2 (study Days 3-7), participants received LCZ696 once daily.
750999|NCT01601470|E1|Reported Event|Period 1: Sildenafil|During Treatment Period 1, on study Day 1, participants received a single dose of sildenafil followed by wash out on Day 2.
751000|NCT01601132|B1|Baseline|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751001|NCT01601132|P1|Participant Flow|Theophylline + Colchicine|Theophylline 300 mg, solution, orally, on Day 1, then colchicine 0.6 mg tablets, orally, twice daily on Days 5–18, then theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751002|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751003|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
751004|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751005|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
751006|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751007|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
751214|NCT01600014|O3|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
751008|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751009|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
751010|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751011|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
751262|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751012|NCT01601132|O2|Outcome|Theophylline + Colchicine|Theophylline 300 mg, solution, orally together with colchicine 0.6 mg, tablet, orally on Day 19 followed by a last dose of colchicine 0.6 mg, tablet, orally, 12 hours later.
751013|NCT01601132|O1|Outcome|Theophylline|Theophylline 300 mg, solution, orally, on Day 1.
751014|NCT01601132|E3|Reported Event|Colchicine + Theophylline|Theophylline 300 mg, solution, orally, single dose and colchicine 0.6 mg, tablets, orally, twice daily, on Day 19.
751015|NCT01601132|E2|Reported Event|Colchicine|Colchicine, 0.6 mg tablet, orally, twice daily, from Days 5-18.
751016|NCT01601132|E1|Reported Event|Theophylline|Theophylline 300 mg, solution, orally, on Day 1, followed by a 4-day washout period.
751017|NCT01600950|B1|Baseline|All Participants|A single 0.3 units/kilogram (U/kg) dose of either LY2963016 or LANTUS was administered subcutaneously on Day 1 of Periods 1 or 2.
751018|NCT01600950|P2|Participant Flow|Lantus/LY2963016|"A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of LY2963016 was administered subcutaneously on Day 1 during Period 2."
751019|NCT01600950|P1|Participant Flow|LY2963016/Lantus|"A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 during Period 1 followed by a minimum washout period of 7 days.~A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 during Period 2."
751020|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
751021|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
751022|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
751023|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
751024|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
751025|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
751026|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
751027|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
751028|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
751029|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
751030|NCT01600950|O2|Outcome|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
751031|NCT01600950|O1|Outcome|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
751032|NCT01600950|E2|Reported Event|Lantus|A single 0.3 U/kg dose of Lantus was administered subcutaneously on Day 1 of Periods 1 or 2.
751033|NCT01600950|E1|Reported Event|LY2963016|A single 0.3 units per kilogram (U/kg) dose of LY2963016 was administered subcutaneously on Day 1 of Periods 1 or 2.
751034|NCT01600885|B1|Baseline|Overall Study|
751035|NCT01600885|P2|Participant Flow|Placebo Then Guanfacine|"During the first study session, the participant will receive a placebo before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI.~Placebo then Guanfacine: During the first study session, the patient will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given 3mg of guanfacine instead of the placebo."
751036|NCT01600885|P1|Participant Flow|Guanfacine Then Placebo|"During the first study session, the participant will receive guanfacine before undergoing a ketamine-infusion fMRI. During the second study session, at least two weeks later, the participant will receive a placebo before undergoing a ketamine-infusion fMRI.~Guanfacine then Placebo: During the first study session, the patient will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.~The second study session will be identical except that the patient will be given a placebo instead of the guanfacine."
751037|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751064|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
751215|NCT01600014|O2|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
751038|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751068|NCT01600716|E1|Reported Event|OnabotulinumtoxinA Treatment Cycle 1|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. Median duration of exposure is 50.7 weeks.
751039|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751040|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751041|NCT01600885|O2|Outcome|Placebo|Subjects were given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751042|NCT01600885|O1|Outcome|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751043|NCT01600885|E2|Reported Event|Placebo|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751044|NCT01600885|E1|Reported Event|Guanfacine|Subjects were given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) was given during the visual fixation scan. Immediately after completion of the 1 min bolus, the subjects received a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation was measured during a spatial working memory task. The entire scan lasted approximately two and a half hours and the ketamine infusion lasted up to one hour and 15 minutes.
751045|NCT01600729|B1|Baseline|All Participants|Participants with facial lines. There was no intervention in this study.
751046|NCT01600729|P1|Participant Flow|All Participants|Participants with facial lines. There was no intervention in this study.
751047|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
751048|NCT01600729|O1|Outcome|All Participants|Participants with facial lines. There was no intervention in this study.
751049|NCT01600729|E1|Reported Event|All Participants|Participants with facial lines. There was no intervention in this study.
751050|NCT01600716|B3|Baseline|Total|Total of all reporting groups
751051|NCT01600716|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
751052|NCT01600716|B1|Baseline|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
751053|NCT01600716|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
751054|NCT01600716|P1|Participant Flow|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
751055|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
751056|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
751057|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
751058|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
751059|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
751060|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
751061|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
751062|NCT01600716|O1|Outcome|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for a second onabotulinumtoxinA injection.
751063|NCT01600716|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, patients could request/qualify for an onabotulinumtoxinA injection.
751065|NCT01600716|E4|Reported Event|Placebo (Normal Saline)/OnabotulinumtoxinA|Placebo (normal saline) is administered into the detrusor at Day 1. After a minimum of 12 weeks, an onabotulinumtoxinA injection is given. Median duration of exposure is 12.2 weeks.
751066|NCT01600716|E3|Reported Event|OnabotulinumtoxinA/OnabotulinumtoxinA Treatment Cycle 2|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1. After a minimum of 12 weeks, a second onabotulinumtoxinA injection is given. Median duration of exposure is 12.5 weeks.
751070|NCT01600703|P2|Participant Flow|Sitagliptin First, Then Placebo|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
751071|NCT01600703|P1|Participant Flow|Placebo First, Then Sitagliptin|placebo, oral, single dose sitagliptin, 100 mg, oral, single dose
751072|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
751073|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
751074|NCT01600703|O2|Outcome|Sitagliptin|sitagliptin, 100 mg, oral, single dose
751075|NCT01600703|O1|Outcome|Placebo|placebo, oral, single dose
751076|NCT01600703|E2|Reported Event|Sitagliptin|sitagliptin, 100mg, oral, single dose
751077|NCT01600703|E1|Reported Event|Placebo|placebo, oral, single dose
751078|NCT01600677|B3|Baseline|Total|Total of all reporting groups
751079|NCT01600677|B2|Baseline|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
751080|NCT01600677|B1|Baseline|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
751081|NCT01600677|P2|Participant Flow|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
751082|NCT01600677|P1|Participant Flow|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
751083|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
751084|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
751085|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
751118|NCT01600287|B2|Baseline|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751119|NCT01600287|B1|Baseline|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751236|NCT01599806|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
751086|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
751126|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751087|NCT01600677|O2|Outcome|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
751088|NCT01600677|O1|Outcome|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
751089|NCT01600677|E2|Reported Event|Usual Care|"Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.~Usual care: Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge."
751090|NCT01600677|E1|Reported Event|Computerized Medication Delivery Unit|"Those hospitalized patients that meet all inclusion and exclusion criteria will be provided with an EMMA MDU for use in their homes for the 90-day period immediately following discharge.~Computerized medication delivery unit: The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common."
751091|NCT01600495|B3|Baseline|Total|Total of all reporting groups
751092|NCT01600495|B2|Baseline|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
751093|NCT01600495|B1|Baseline|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
751094|NCT01600495|P2|Participant Flow|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
751095|NCT01600495|P1|Participant Flow|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
751096|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
751097|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
751098|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
751099|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
751100|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
751101|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm.
751102|NCT01600495|O2|Outcome|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
751103|NCT01600495|O1|Outcome|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
751104|NCT01600495|E2|Reported Event|Control Group|Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group.
751105|NCT01600495|E1|Reported Event|Experimental TENS|TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm
751106|NCT01600326|B3|Baseline|Total|Total of all reporting groups
751120|NCT01600287|P2|Participant Flow|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751121|NCT01600287|P1|Participant Flow|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751122|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751237|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751107|NCT01600326|B2|Baseline|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
751108|NCT01600326|B1|Baseline|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
751109|NCT01600326|P2|Participant Flow|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
751110|NCT01600326|P1|Participant Flow|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
751111|NCT01600326|O2|Outcome|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
751112|NCT01600326|O1|Outcome|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
751113|NCT01600326|O2|Outcome|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
751114|NCT01600326|O1|Outcome|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
751115|NCT01600326|E2|Reported Event|Plasma Injection Group|"Treatment is Ultrasound guided platelet rich plasma injection.~Ultrasound guided platelet rich plasma injection: Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
751116|NCT01600326|E1|Reported Event|Tenotomy Group|"Subject enrolled in this arm will receive treatment for tendinitis and pain evaluation of pain pre and post treatment.~Tenotomy (no injection): Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy."
751117|NCT01600287|B3|Baseline|Total|Total of all reporting groups
751238|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751123|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751124|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751125|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751253|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751254|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751127|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751128|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751129|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751130|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751131|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751132|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751133|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751134|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751135|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751136|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751137|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751138|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751139|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751140|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751141|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751142|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751143|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751144|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751145|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751146|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751147|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751148|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751149|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751150|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751151|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751152|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751153|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751211|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|See primary endpoint for previously defined description
751154|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751155|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751156|NCT01600287|O2|Outcome|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751157|NCT01600287|O1|Outcome|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751158|NCT01600287|E2|Reported Event|Manual Group|dosage of propofol was adjusted manually by the attending anesthesiologist through the keyboard of the PC attached to the syringe pump for both induction and maintenance.
751159|NCT01600287|E1|Reported Event|IAADS Group|Both induction and maintenance of anesthesia was done automatically by IAADS according to age, sex, height of the patient, target BIS(50) entered, risk status and maximum allowable rate entered.
751160|NCT01600222|B1|Baseline|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751161|NCT01600222|P1|Participant Flow|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
751162|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Once daily for up to 4 weeks
751163|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751164|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751165|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751166|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751167|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751168|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751169|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751170|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751171|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751172|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751173|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751174|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751175|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751176|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751177|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751178|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751179|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751180|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751181|NCT01600222|O1|Outcome|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751182|NCT01600222|E1|Reported Event|LEO 90100|LEO 90100: Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
751183|NCT01600092|B3|Baseline|Total|Total of all reporting groups
751184|NCT01600092|B2|Baseline|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751185|NCT01600092|B1|Baseline|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751186|NCT01600092|P2|Participant Flow|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751187|NCT01600092|P1|Participant Flow|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751188|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751189|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751190|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751212|NCT01600014|O5|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
751245|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751191|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751192|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751255|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751256|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751257|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751193|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751194|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751195|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751196|NCT01600092|O2|Outcome|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751197|NCT01600092|O1|Outcome|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751198|NCT01600092|E2|Reported Event|RotaTeq™ Existing Formulation|Three 2.0 mL oral doses of RotaTeq™ existing formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751199|NCT01600092|E1|Reported Event|RotaTeq™ Experimental Formulation|Three 2.0 mL oral doses of RotaTeq™ experimental formulation. Vaccination 1 will be administered between 6 and 12 weeks of age and the third vaccination will be administered before 32 weeks of age. Each vaccination will be separated from the next by ≥ 4 weeks (28 days).
751200|NCT01600053|B1|Baseline|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
751201|NCT01600053|P1|Participant Flow|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
751202|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
751203|NCT01600053|O1|Outcome|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
751204|NCT01600053|E1|Reported Event|Lenalidomide|"Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles~Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each."
751205|NCT01600014|B1|Baseline|Ingenol Mebutate 0.015% Gel (1.& 2. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or controlled repeat use (2nd cycle) treatment of recalcitrant or recurrent AK lesions
751206|NCT01600014|P2|Participant Flow|Vehicle Gel (2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with vehicle gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
751207|NCT01600014|P1|Participant Flow|Ingenol Mebutate Gel, 0.015% (1st & 2nd Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by observation and/or repeat use (2nd cycle) once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area, in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup) with follow-up until Week 52
751208|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|See primary endpoint for previously defined description
751209|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|See primary endpoint for previously defined description
751210|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|See primary endpoint for previously defined description
751239|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751216|NCT01600014|O1|Outcome|Open Label Only (1st Cycle)|Subjects only treated during 1st cycle (450 participants excluding 203 participants also included in the 2nd cycle)
751217|NCT01600014|O4|Outcome|Vehicle Gel Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
751263|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751218|NCT01600014|O3|Outcome|Ingenol Mebutate Gel 0.015% Field Recurrent Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 26 or Week 44 with follow-up until Week 52
751219|NCT01600014|O2|Outcome|Vehicle Gel Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with vehicle gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
751220|NCT01600014|O1|Outcome|Ingenol Mebutate Gel, 0.015% Field Recalcitrant Subgroup|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel (1st cycle) within a 25 cm^2 treatment area on the face or scalp, followed by once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (2nd cycle), in a randomised, controlled, double-blind setting, at Week 8 with follow-up until Week 52
751221|NCT01600014|E3|Reported Event|Vehicle Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with vehicle gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
751222|NCT01600014|E2|Reported Event|Ingenol Mebutate 0.015% Gel (2. Cycle)|Repeat use once daily for 3 consecutive days with ingenol mebutate 0.015% gel of the same treatment area (25 cm2 treatment area on the face or scalp) in a randomised, controlled, double-blind setting, at Week 8 (field recalcitrant subgroup) or Week 26 or Week 44 (field recurrent subgroup)
751223|NCT01600014|E1|Reported Event|Ingenol Mebutate 0.015% Gel (1. Cycle)|Open label topical field treatment once daily for 3 consecutive days with ingenol mebutate 0.015% gel within a 25 cm2 treatment area on the face or scalp
751224|NCT01599832|B1|Baseline|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751225|NCT01599832|P1|Participant Flow|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751226|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751227|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751228|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751229|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751230|NCT01599832|O1|Outcome|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751231|NCT01599832|E1|Reported Event|Treatment (Pazopanib Hydrochloride, DCE-MRI)|"Patients receive pazopanib hydrochloride PO QD in the absence of disease progression or unacceptable toxicity. Patients undergo dynamic contrast-enhanced MRI at baseline, day 8, and prior to courses 3, 5, and 7.~pazopanib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Undergo dynamic contrast-enhanced magnetic resonance imaging~pharmacogenomic studies: Correlative studies"
751232|NCT01599806|B3|Baseline|Total|Total of all reporting groups
751233|NCT01599806|B2|Baseline|Doripenem|Doripenem treatment group
751234|NCT01599806|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
751235|NCT01599806|P2|Participant Flow|Doripenem|Doripenem treatment group
751246|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751247|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751248|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751249|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751250|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751251|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751252|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751264|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751265|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751266|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751267|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751268|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751269|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751270|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751271|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751272|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751273|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751274|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751275|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751276|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751277|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751278|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751279|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751280|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751281|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751282|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751283|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751284|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751285|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751286|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751287|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751288|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751289|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751290|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751291|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751292|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751293|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751294|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751295|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751296|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751297|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751298|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751299|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751300|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751301|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751302|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751303|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751304|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751305|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751306|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751307|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751308|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751309|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751310|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751311|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751312|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751313|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751314|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751315|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751316|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751317|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751318|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751319|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751320|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751321|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751322|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751323|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751324|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751325|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751326|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751328|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751329|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751330|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751331|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751332|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751333|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751334|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751335|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751336|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751337|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751338|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751339|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751340|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751341|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751342|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751343|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751344|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751345|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751346|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751347|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751348|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751349|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751350|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751351|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751352|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751353|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751354|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751355|NCT01599806|O2|Outcome|Doripenem|Doripenem treatment group
751356|NCT01599806|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751357|NCT01599806|E2|Reported Event|Doripenem|Doripenem treatment group
751358|NCT01599806|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
751359|NCT01599741|B1|Baseline|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
751360|NCT01599741|P1|Participant Flow|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper directly followed by DSA with ClarityIQ
751361|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
751362|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
751363|NCT01599741|O1|Outcome|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ or visa versa.
751364|NCT01599741|E1|Reported Event|Allura-Xper-ClarityIQ|DSA acquisition of iliac artery with AlluraXper followed by DSA with ClarityIQ
751365|NCT01599650|B4|Baseline|Total|Total of all reporting groups
751366|NCT01599650|B3|Baseline|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751367|NCT01599650|B2|Baseline|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751368|NCT01599650|B1|Baseline|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751369|NCT01599650|P3|Participant Flow|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751370|NCT01599650|P2|Participant Flow|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751371|NCT01599650|P1|Participant Flow|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751372|NCT01599650|O1|Outcome|3- Laser Monotherapy|laser therapy + Ranibizumab 0.5 mg after Month 6
751373|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751374|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751375|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751376|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751377|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751378|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751379|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751380|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751381|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751382|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751383|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751384|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751385|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751386|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751387|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751388|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751389|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751390|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751391|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751392|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751393|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751394|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751395|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751396|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751397|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751398|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751399|NCT01599650|O3|Outcome|3-laser Monotherapy|after 6 months, laser patients could be treated with ranibizumab
751400|NCT01599650|O2|Outcome|2-ranibizumab With Laser|Ranibizumab 0.5 mg + laser
751401|NCT01599650|O1|Outcome|1-ranibizumab Monotherapy|laser therapy + Ranibizumab 0.5 mg
751402|NCT01599650|E4|Reported Event|Laser Monotherapy Without Ranibizumab 0.5 mg From Month 6|Laser monotherapy without Ranibizumab 0.5 mg from Month 6
751403|NCT01599650|E3|Reported Event|Laser Monotherapy With Ranibizumab 0.5 mg From Month 6|Laser monotherapy with Ranibizumab 0.5 mg from Month 6
751404|NCT01599650|E2|Reported Event|Ranibizumab 0.5mg + Laser|"Ranibizumab 0.5mg + Laser~[1] Safety set was summarized based on actual treatment received. There were 3 laser monotherapy patients who received ranibizumab and 1 ranibizumab patient who received laser treatment which resulted in percentages > 100% for the ranibizumab + laser arm."
751405|NCT01599650|E1|Reported Event|Ranibizumab 0.5mg|Ranibizumab 0.5mg
751406|NCT01599637|B4|Baseline|Total|Total of all reporting groups
751514|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751407|NCT01599637|B3|Baseline|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
751408|NCT01599637|B2|Baseline|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
751409|NCT01599637|B1|Baseline|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751410|NCT01599637|P3|Participant Flow|Healthy Volunteers|Healthy volunteer data was collected at baseline only. These healthy volunteers did not receive any test treatment. The data collected from these individuals was used to provide a reference to help characterize the levels of skin biopsy markers and were used in the descriptive analyses but not formally compared with the corresponding levels in the treated subjects
751411|NCT01599637|P2|Participant Flow|Placebo to IGE025|Placebo administered subcutaneously every 4 weeks at the study center.
751412|NCT01599637|P1|Participant Flow|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751413|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751414|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751415|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751416|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751417|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751418|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751419|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751420|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751421|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751422|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751423|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751424|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751425|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751426|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751427|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751428|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751429|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751430|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751431|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751432|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751433|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751434|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751435|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751436|NCT01599637|O2|Outcome|Urticaria Patients|All patients for study at baseline
751437|NCT01599637|O1|Outcome|Healthy Subjects|Baseline Value, healthy volunteers, no treatment applied
751438|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751439|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751440|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751441|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751442|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751443|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751444|NCT01599637|O2|Outcome|Placebo IGE025|Dosed every 4 weeks up to 12 weeks
751445|NCT01599637|O1|Outcome|IGE025|Dosed every 4 weeks up to 12 weeks
751446|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751447|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751448|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751449|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751450|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751451|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751452|NCT01599637|O2|Outcome|Placebo IGE025|Placebo IGE025 administered subcutaneously every 4 weeks at the study center
751453|NCT01599637|O1|Outcome|IGE025|IGE025 administered subcutaneously every 4 weeks at the study center
751454|NCT01599637|E2|Reported Event|Placebo|Placebo administered subcutaneously every 4 weeks at the study center.
751455|NCT01599637|E1|Reported Event|IGE025 300mg|IGE025 administered subcutaneously every 4 weeks at the study center
751456|NCT01599585|B3|Baseline|Total|Total of all reporting groups
751457|NCT01599585|B2|Baseline|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751458|NCT01599585|B1|Baseline|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751459|NCT01599585|P2|Participant Flow|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751460|NCT01599585|P1|Participant Flow|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751461|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751462|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751463|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751464|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751465|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751466|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751509|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751544|NCT01599104|B2|Baseline|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751467|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751468|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751607|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
751469|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751470|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751471|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751472|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751473|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751474|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751475|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751476|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751477|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751478|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751479|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751480|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751481|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751482|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751483|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751484|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751485|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751486|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751487|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751488|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751489|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751490|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751491|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751492|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751493|NCT01599585|O2|Outcome|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751494|NCT01599585|O1|Outcome|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751495|NCT01599585|E2|Reported Event|In-Person|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week with allowance for rescheduled sessions). The sessions will be conducted in a clinic setting at The National Center for Telehealth & Technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751496|NCT01599585|E1|Reported Event|In Home|"Participants in this condition will receive 8 sessions of BA treatment over the course of approximately 8 weeks (one session per week). The sessions will be conducted in their homes using an Army approved secure web-based video conferencing system. BA has been successfully delivered in this time frame, and it has been delivered via in-home video conferencing technology.~Behavioral Activation: Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies."
751497|NCT01599325|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751498|NCT01599325|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751499|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751500|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751501|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751502|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751503|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751504|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751505|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751506|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751507|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751508|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751543|NCT01599104|B3|Baseline|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751592|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
751510|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751511|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751512|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751513|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
763039|NCT01545700|O12|Outcome|Dexamethasone 8 mg 0-4 Hours-1 Hour|
751515|NCT01599325|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751516|NCT01599325|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
751517|NCT01599234|B3|Baseline|Total|Total of all reporting groups
751518|NCT01599234|B2|Baseline|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751519|NCT01599234|B1|Baseline|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751520|NCT01599234|P2|Participant Flow|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751521|NCT01599234|P1|Participant Flow|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751522|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751523|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751524|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751525|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751526|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751527|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751528|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751529|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751530|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751531|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751532|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751533|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751534|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751535|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751536|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751537|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751538|NCT01599234|O2|Outcome|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751539|NCT01599234|O1|Outcome|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751540|NCT01599234|E2|Reported Event|Placebo|Contains no active drug but colourants and excipients. Maximum permitted dose was 24 actuations in 24 hours.
751541|NCT01599234|E1|Reported Event|Sativex|Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 24 actuations (THC 65 mg: CBD 60 mg) in 24 hours.
751542|NCT01599104|B4|Baseline|Total|Total of all reporting groups
751545|NCT01599104|B1|Baseline|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751546|NCT01599104|P3|Participant Flow|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751547|NCT01599104|P2|Participant Flow|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751548|NCT01599104|P1|Participant Flow|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751549|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751550|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751551|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751552|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751553|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
763040|NCT01545700|O11|Outcome|Dexamethasone 8 mg 0-4 Hours-baseline|
751554|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751555|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751556|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751557|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751558|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751559|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751560|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751561|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751562|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751563|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751564|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751565|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751566|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751567|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751568|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751569|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751570|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751571|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751572|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751573|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751574|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751575|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751576|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751577|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751578|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751579|NCT01599104|O3|Outcome|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751580|NCT01599104|O2|Outcome|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751581|NCT01599104|O1|Outcome|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751582|NCT01599104|E3|Reported Event|Olmesartan 20 mg|Olmesartan 20 mg tablet and a placebo tablet once daily for 8 weeks
751583|NCT01599104|E2|Reported Event|LCZ696 400 mg|LCZ696 200 mg tablet and a placebo tablet once daily for one week, then up-titrated to 400 mg once daily for the remaining 7 weeks
751584|NCT01599104|E1|Reported Event|LCZ696 200 mg|LCZ696 200 mg tablet and a placebo tablet once daily for eight weeks
751585|NCT01598987|B1|Baseline|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
751586|NCT01598987|P1|Participant Flow|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
751587|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
751588|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
751589|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
751590|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
751591|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
751594|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
751595|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
751596|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
751597|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
751598|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
751599|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
751600|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
751601|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
751602|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
751603|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
751604|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
751605|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
751606|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
751608|NCT01598987|O7|Outcome|Total|The classified change from baseline in growth percentiles cross-tabulated against baseline categories of growth percentiles.
751609|NCT01598987|O6|Outcome|>95% Percentile|Growth percentile category
751610|NCT01598987|O5|Outcome|>75% - 95% Percentile|Growth percentile category
751611|NCT01598987|O4|Outcome|>50% - 75% Percentile|Growth percentile categpru
751612|NCT01598987|O3|Outcome|>25% - 50% Percentile|Growth percentile category
751613|NCT01598987|O2|Outcome|>5% - 25% Percentile|Growth percentile category
751614|NCT01598987|O1|Outcome|<=5% Percentile|Growth percentile category
751615|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
751616|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
751617|NCT01598987|O1|Outcome|Everolimus Based Regimen|"Conversion at baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids to a regimen which contains everolimus combined with reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).~The dosing schedule was twice daily, 12 hours apart."
751618|NCT01598987|E1|Reported Event|All Patients|All patients
751619|NCT01598779|B1|Baseline|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
751620|NCT01598779|P1|Participant Flow|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
751621|NCT01598779|O1|Outcome|Women With External Genital Warts|"Women age 15–45 attending an outpatient consultation at clinics of the investigators or at University of Buenos Aires, with a lesion suspected of being HPV related were eligible to enter in the study. The main manifestations of genital warts include cauliflower-like condylomata acuminata lesions, keratotic and smooth papular warts, subclinical flat warts, Patients previously vaccinated with commercially available vaccines (Gardasil™ or Cervarix™) were not invited to participate.~Inclusion criteria: women between 15 and 45 years old, with External Genital Warts. We will exclude women under treatment corticosteroids, having an immunosuppressive disease, pregnancy, cancer related to HPV, VIN confirmed by histology, other sexually transmitted infection, HIV+ known"
751622|NCT01598779|E1|Reported Event|Patients Having External Genital Warts|"Patients were examined by experienced ginecologists in their first visit to evaluate the presence of lesions suspicious of condilomata acuminate, If they had lesions suspicious of gential warts, they were invited to participate and given an informed consent. Biopsied from genital warts were taken with an excisional procedure under local anesthesia. Biopsied sample was splinted in order to obtain two pieces, one of them was kept in formol solution (10%) and sent to the pathology laboratory for hematoxiline - eosine paint and lecture. All biopsies were analyzed by expert pathologists in order to confirm the histological diagnosis of genital warts. The other piece was sent to the laboratory to investigate the presence of HPV 6 and 11.~In this first visit, the chronogram of activities included the detection of external genital warts, review of the criteria for inclusion and exclusion, firm informed consent, complete the questionnaire and take the biopsy, on a 2nd visit we informed the"
751623|NCT01598740|B3|Baseline|Total|Total of all reporting groups
751624|NCT01598740|B2|Baseline|CLP/CLP + Spiro|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
751625|NCT01598740|B1|Baseline|CLP + Spiro/CLP|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
751626|NCT01598740|P2|Participant Flow|CLP (7 Days), Washout (7 Days), CLP + Spiro (7 Days)|Subjects in this group received administration of CLP alone orally in Period 1/coadministration of CLP orally and spironolactone orally in Period 2.
751627|NCT01598740|P1|Participant Flow|CLP + Spiro (7 Days), Washout (7 Days), CLP (7 Days)|Subjects in this group received coadministration of CLP orally and spironolactone orally in Period 1/administration of CLP orally alone in Period 2.
751628|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
751629|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|CLP: oral administration
751630|NCT01598740|O2|Outcome|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
751631|NCT01598740|O1|Outcome|Treatment Group: CLP Alone|oral administration
763041|NCT01545700|O10|Outcome|Dexamethasone 4 mg 0-4 Hours-4 Hours|
751632|NCT01598740|E2|Reported Event|Treatment Group: CLP + Spironolactone|CLP: oral administration Spironolactone: oral administration
751633|NCT01598740|E1|Reported Event|Treatment Group: CLP Alone|oral administration
751634|NCT01598610|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751635|NCT01598610|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751636|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751637|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751638|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751639|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751640|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751641|NCT01598610|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751642|NCT01598610|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use CONTOUR® PLUS Investigational BG Monitoring System.
751643|NCT01598545|B1|Baseline|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751644|NCT01598545|P1|Participant Flow|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751645|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751646|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751647|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751648|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751649|NCT01598545|O1|Outcome|Hydromorphone|"Laboring patients having a cesarean section will receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751650|NCT01598545|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally~Hydromorphone: Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.~ED50 of hydromorphone was 5.6 mcg +/- 1.8 mcg."
751651|NCT01598532|B1|Baseline|Transcranial LED Treatment|"All study subjects received LED treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy. Each session was 30 minutes in duration. Neuropsychological testing was administered at the following time points: within 1 week of the first LED treatment and within 1 week, 1 month & 2 months following the last LED treatment.~The neuropsychological testing included: 1)Stroop test, 2) California Verbal Learning Test-II (CVLT- II), Short Delay Free & Cued Recall, Long Delay Free & Cued Recall, 3) Delis-Kaplan Executive Function (D-KEF) -Trails Test, 4) Controlled Oral Word Association Test (FAS), & 5) Digit Span, Forwards & Backwards.~The following tests were not analyzed due to collinearity with other measures (r > .8): Short Delay Free & Cued Recall, Long Delay Cued Recall, & Delis-Kaplan Executive Function (D-KEF) -Trails Test."
751652|NCT01598532|P1|Participant Flow|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
751698|NCT01598207|E2|Reported Event|Placebo|Placebo: 5mg BID, orally for 1 month
751699|NCT01598207|E1|Reported Event|Marinol|Marinol: 5mg BID, orally for 1 month
754197|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
751653|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
751654|NCT01598532|O1|Outcome|Transcranial LED Treatment|"All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.~MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each."
751655|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
752150|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751656|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
751657|NCT01598532|O1|Outcome|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light). Each session was 30 minutes in duration.
751658|NCT01598532|O1|Outcome|Transcranial LED Treatment|MedX Health Phototherapy (light therapy): The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
751659|NCT01598532|E1|Reported Event|Transcranial LED Treatment|Population was Males and Females, ages 18 to 65 years who sustained a mild traumatic brain injury at least 6 months prior to study participation. All study subjects received treatment during 6-Week period (3x per week) for a total of 18 Transcranial LED Treatments using the MedX Health Phototherapy (light and laser). Each session was 30 minutes in duration.
751660|NCT01598506|B1|Baseline|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
751661|NCT01598506|P1|Participant Flow|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
751662|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
751663|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
751664|NCT01598506|O1|Outcome|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
751665|NCT01598506|E1|Reported Event|Hydromorphone|"Laboring patients receive ED50 of hydromorphone one time intrathecally.~ED50 of hydromorphone was 12.7 mcg +/- 3.27."
751666|NCT01598428|B1|Baseline|Cataract|
751667|NCT01598428|P1|Participant Flow|Cataract|During cataract surgery, the anterior capsule was unpolished intraoperatively in one eye; the anterior capsule and the equator of capsule was extensively polished intraoperatively in the other eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
751668|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
751669|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
751670|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
751671|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
751672|NCT01598428|O2|Outcome|Anterior Capsule Polishing|During cataract surgery, the anterior capsule and the equator of capsule was extensively polished intraoperatively in this eye. Anterior capsule polishing: polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
751673|NCT01598428|O1|Outcome|Control|During cataract surgery, the anterior capsule was unpolished intraoperatively in this eye;
751674|NCT01598428|E1|Reported Event|Cataract|
751675|NCT01598350|B1|Baseline|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
751676|NCT01598350|P1|Participant Flow|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
751677|NCT01598350|O1|Outcome|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
751678|NCT01598350|E1|Reported Event|Orthotic|"Orthotic Use~Supramalleolar Orthoses (Cascade) : Walk wearing supramalleolar orthoses - three trial"
751679|NCT01598207|B3|Baseline|Total|Total of all reporting groups
751680|NCT01598207|B2|Baseline|Placebo|Placebo: 5mg BID, orally for 1 month
751681|NCT01598207|B1|Baseline|Marinol|Marinol: 5mg BID, orally for 1 month
751682|NCT01598207|P2|Participant Flow|Placebo|Placebo: 5mg BID, orally for 1 month
751683|NCT01598207|P1|Participant Flow|Marinol|Marinol: 5mg BID, orally for 1 month
751684|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
751685|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
751686|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
751687|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
751688|NCT01598207|O2|Outcome|Placebo|Placebo: 5mg BID, orally for 1 month
751689|NCT01598207|O1|Outcome|Marinol|Marinol: 5mg BID, orally for 1 month
751700|NCT01598129|B1|Baseline|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751701|NCT01598129|P1|Participant Flow|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751702|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~ONCOS-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751761|NCT01597596|E2|Reported Event|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
752151|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
751703|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751704|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751705|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751706|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751707|NCT01598129|O1|Outcome|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751708|NCT01598129|E1|Reported Event|CGTG-102|"CGTG-102 dose escalation~CGTG-102: GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide."
751709|NCT01598064|B3|Baseline|Total|Total of all reporting groups
751710|NCT01598064|B2|Baseline|Placebo|Placebo 1 pack tid for 8 weeks
751711|NCT01598064|B1|Baseline|GK#10|GK#10 1 pk tid for 8 weeks
751712|NCT01598064|P2|Participant Flow|Placebo|Placebo 1 pack tid for 8 weeks
751713|NCT01598064|P1|Participant Flow|GK#10|GK#10 1 pk tid for 8 weeks
751714|NCT01598064|O2|Outcome|Placebo: 8 Week|Placebo 1 pack three times per day for 8 weeks, and F/U ALT level.
751715|NCT01598064|O1|Outcome|GK#10: 8 Week|GK#10 1 pack three times per day for 8 weeks, and F/U ALT level.
751716|NCT01598064|O2|Outcome|Placebo|Placebo 1 pack tid for 8 weeks
751717|NCT01598064|O1|Outcome|GK#10|GK#10 1 pk tid for 8 weeks
751718|NCT01598064|E2|Reported Event|Placebo|Placebo 1 pack tid for 8 weeks
751719|NCT01598064|E1|Reported Event|GK#10|GK#10 1 pk tid for 8 weeks
751720|NCT01597908|B3|Baseline|Total|Total of all reporting groups
751721|NCT01597908|B2|Baseline|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751722|NCT01597908|B1|Baseline|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751723|NCT01597908|P2|Participant Flow|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751724|NCT01597908|P1|Participant Flow|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 milligrams (mg) orally twice daily (BID) and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751725|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751726|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751727|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751728|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751729|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751754|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
752137|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751730|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751731|NCT01597908|O2|Outcome|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751732|NCT01597908|O1|Outcome|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751733|NCT01597908|E2|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751734|NCT01597908|E1|Reported Event|Dabrafenib Plus Trametinib|Participants received dabrafenib 150 mg orally BID and trametinib 2 mg orally once daily. Treatment continued until disease progression, death, unacceptable toxicity, or withdrawal of consent. Treatment beyond progression was allowed subject to consultation with the GlaxoSmithKline medical monitor.
751735|NCT01597843|B4|Baseline|Total|Total of all reporting groups
751736|NCT01597843|B3|Baseline|Education After Data Collection Complete|This group received a similar intervention, but after all quantitative data collection complete.
751737|NCT01597843|B2|Baseline|Second Intervention Group|"The group that receives the intervention second. The intervention is the same as for the first group.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
751738|NCT01597843|B1|Baseline|First Educational Intervention Group|"Group that receives intervention first. The intervention is a series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV.~Education: Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV."
751739|NCT01597843|P3|Participant Flow|Control First Round; Control Second Round; Intervention|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
751740|NCT01597843|P2|Participant Flow|Control First Round; Education in Second Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 6-9. They completed survey rounds 1 and 2 before receiving the intervention and survey round 3 after they received the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
751741|NCT01597843|P1|Participant Flow|Education in First Round|Four of twelve posts were in this group and were randomized to receive a series of training sessions. The training sessions were in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. The participants at these 4 posts received the intervention in study months 1-5. They completed survey round 1 before receiving the intervention and survey rounds 2 and 3 after receiving the intervention. The number of participants at any post who showed up to respond to any of the three survey rounds varied.
751742|NCT01597843|O3|Outcome|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
751743|NCT01597843|O2|Outcome|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
751744|NCT01597843|O1|Outcome|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
751745|NCT01597843|E3|Reported Event|Control First Round; Control Second Round; Intervention|This group received the intervention in study months 10 - 14. They completed all three survey rounds before receiving the intervention.
751746|NCT01597843|E2|Reported Event|Control First Round; Education in Second Round|The intervention was delivered to 3 groups of 4 posts in sequence. The posts in this second round received the intervention over the second study period, from month 6 through month 9. they completed survey rounds 1 and 2 before receiving the intervention, survey round 3 after.
751747|NCT01597843|E1|Reported Event|Education in First Round|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV. This group received the intervention during study months 1-5, following survey 1, prior to survey rounds 2 and 3.
751748|NCT01597596|B3|Baseline|Total|Total of all reporting groups
751749|NCT01597596|B2|Baseline|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751750|NCT01597596|B1|Baseline|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751751|NCT01597596|P2|Participant Flow|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751752|NCT01597596|P1|Participant Flow|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg intravenous (IV) infusion every other week (QOW) for 52 weeks.
751753|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751755|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751756|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751757|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751758|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751759|NCT01597596|O2|Outcome|Alglucosidase Alfa 160 L Material (US Participants)|Alglucosidase alfa (160 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751760|NCT01597596|O1|Outcome|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751762|NCT01597596|E1|Reported Event|Alglucosidase Alfa 4000 L Material (Non-US Participants)|Alglucosidase alfa (4000 L material) 20 mg/kg IV infusion QOW for 52 weeks.
751763|NCT01597492|B3|Baseline|Total|Total of all reporting groups
751764|NCT01597492|B2|Baseline|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
751765|NCT01597492|B1|Baseline|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
751766|NCT01597492|P2|Participant Flow|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
751767|NCT01597492|P1|Participant Flow|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
751768|NCT01597492|O2|Outcome|Belimumab Plus Late Vaccination|Participants received pneumococcal vaccination on Day 168 (Week 24). Open-label belimumab 10 mg/kg IV was dosed on Days 0, 14, 28, and every 28 days thereafter until Week 28 (a total of 9 doses) plus standard therapy for SLE.
751769|NCT01597492|O1|Outcome|Belimumab Plus Early Vaccination|Participants received pneumococcal vaccination on Day 0, 4 weeks prior to the first dose of belimumab. Open-label belimumab 10 mg/kg IV was dosed on Days 28, 42, 56, and every 28 days thereafter until Week 32 (a total of 9 doses) plus standard therapy for SLE.
751770|NCT01597492|E2|Reported Event|Belimumab Plus Late Vaccination|Belimumab plus Late Vaccination
751771|NCT01597492|E1|Reported Event|Belimumab Plus Early Vaccination|Belimumab plus Early Vaccination
751772|NCT01597479|B3|Baseline|Total|Total of all reporting groups
751773|NCT01597479|B2|Baseline|Non dPNBs Group|Non intervention in postoperative period
751774|NCT01597479|B1|Baseline|dPNBs Group|dPNBs on radial and median nerves at the elbow in postoperative period, before discharge
751775|NCT01597479|P2|Participant Flow|No Intervention (no dPNBs Group)|In patients of no dPNBs group didn't performed any intervention after surgery.
751776|NCT01597479|P1|Participant Flow|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"In dPNBs group, we practice distal peripheral nerves blocks guided by ultrasound and neurostimulator.~Levobupivacaine: In dPNBs group, we practice ultrasound guided distal peripheral nerve blocks on radial and median nerves using low volume and low concentration of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve).~We performed dPNBs in the postoperative period. Deffered dPNBs under the influence of axillary block didn't cause patient disconfort. We considered the technique safety due to ultrasound guidance."
751777|NCT01597479|O2|Outcome|Non dPNBs Group|In this group any intervention was done.
751778|NCT01597479|O1|Outcome|dPNBs Group|we practiced ultrasound guided dPNBs on radial and median nerves using a long acting and low concentration local anesthetic (0.125% levobupivacaine, 5 ml per nerve).
751779|NCT01597479|O2|Outcome|Non Distal Peripheral Nerve Blocks (Non dPNBs Group)|Patients in non dPNBs didn't received any intervention in the postoperatively period.
751780|NCT01597479|O1|Outcome|Distal Peripheral Nerve Blocks Group (dPNBs Group)|"We practiced ultrasound guided dPNBs on radial and median nerves, after surgery, before discharge.~Distal median nerve block was performed at the elbow, in the internal bicipital channel.~Distal radial nerve block was performed at approximately the junction of the middle and distal thirds of the arm.~We use 5ml per nerve of levobupivacaine 0,125% for target nerve blocks."
751781|NCT01597479|E1|Reported Event|Distal Peripheral Nerve Block Group|Any patient undergoing ultrasound guided distal peripheral nerve block reported any complication.
751782|NCT01597440|B3|Baseline|Total|Total of all reporting groups
751783|NCT01597440|B2|Baseline|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
751784|NCT01597440|B1|Baseline|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
751785|NCT01597440|P2|Participant Flow|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
751805|NCT01597245|P6|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
751786|NCT01597440|P1|Participant Flow|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
751787|NCT01597440|O2|Outcome|Placebo|"Standard of Care Therapy~Standard of Care: Standard of Care"
751809|NCT01597245|P2|Participant Flow|50 mg Etanercept (ETN) - Induction Period|50 milligrams (mg) ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
763042|NCT01545700|O9|Outcome|Dexamethasone 4 mg 0-4 Hours-3 Hours|
751788|NCT01597440|O1|Outcome|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG)~The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
751789|NCT01597440|O2|Outcome|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
751790|NCT01597440|O1|Outcome|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
751791|NCT01597440|E2|Reported Event|Placebo|"Standard of Care therapy~Standard of Care: Standard of Care"
751792|NCT01597440|E1|Reported Event|Carbaglu|"Active NCG & Standard of Care~N-carbamylglutamate: Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.~This drug will be administered for 7 days after admission or until discharge (whichever is sooner).~Standard of Care: Standard of Care"
751793|NCT01597245|B5|Baseline|Total|Total of all reporting groups
751794|NCT01597245|B4|Baseline|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751795|NCT01597245|B3|Baseline|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751796|NCT01597245|B2|Baseline|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751797|NCT01597245|B1|Baseline|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751798|NCT01597245|P13|Participant Flow|Ixe Q2W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751799|NCT01597245|P12|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751800|NCT01597245|P11|Participant Flow|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751801|NCT01597245|P10|Participant Flow|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
751802|NCT01597245|P9|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751803|NCT01597245|P8|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
751804|NCT01597245|P7|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751806|NCT01597245|P5|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
754198|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
751807|NCT01597245|P4|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12
751808|NCT01597245|P3|Participant Flow|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W:Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
752025|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
751810|NCT01597245|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751811|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751812|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751813|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751814|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751815|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751816|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751817|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751818|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751819|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751820|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751821|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751822|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751823|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751824|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751825|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751826|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751827|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751828|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751829|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751830|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751831|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751832|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751833|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
752152|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751834|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751835|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751836|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751837|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751838|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751839|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751840|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751841|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751842|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751843|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751844|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751845|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751846|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751847|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751848|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751849|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751850|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751851|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751852|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751853|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751854|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
752138|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
751855|NCT01597245|O3|Outcome|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751856|NCT01597245|O2|Outcome|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56 .
752153|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
751857|NCT01597245|O1|Outcome|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
751858|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751859|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751860|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751861|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751862|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751863|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751864|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751865|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751866|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751867|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751868|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751869|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751870|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751871|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W; Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751872|NCT01597245|O2|Outcome|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751873|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751874|NCT01597245|O4|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751875|NCT01597245|O3|Outcome|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W: Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751876|NCT01597245|O2|Outcome|50 mg Etanercept (ETN) - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751877|NCT01597245|O1|Outcome|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
752022|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
751878|NCT01597245|E14|Reported Event|Ixe Q4W Maintenance Period Relapsed Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751879|NCT01597245|E13|Reported Event|Ixe Q2W NonResp/Ixe Q4W Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
752026|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
751880|NCT01597245|E12|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751881|NCT01597245|E11|Reported Event|ETN NonResp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received ETN in Induction Period (Weeks 0 to 12) and classified as non-responders were administered 2 SC injections of placebo at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751882|NCT01597245|E10|Reported Event|ETN Resp/Placebo Maintenance Period Secondary Pop|Participants who received ETN during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
751883|NCT01597245|E9|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751884|NCT01597245|E8|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
751885|NCT01597245|E7|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
751886|NCT01597245|E6|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection and a Placebo for ixe injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56. To maintain blinding with Q4W dose regimen, Placebo for ixe given as 1 SC injection at every 4 weeks from Week 16 through Week 56.
751887|NCT01597245|E5|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
751888|NCT01597245|E4|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 2, 4, 6, 8, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751889|NCT01597245|E3|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W): (Weeks 4 and 8). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10. Placebo for ETN (1 SC injection) was administered twice weekly starting at Week 0 up to Week 12.
751890|NCT01597245|E2|Reported Event|50 mg ETN - Induction Period|50 mg ETN was administered by 1 SC injection twice weekly (every 3-4 days) up to Week 12. Placebo for ixe was administered as 2 SC injections at Week 0 followed by Placebo for ixe administered as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
751891|NCT01597245|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 subcutaneous (SC) injections Q2W up through Week 10. Placebo for ETN (1 SC injection) administered twice weekly (every 3 to 4 days) starting at Week 0 up to Week 12.
751892|NCT01597141|B3|Baseline|Total|Total of all reporting groups
751893|NCT01597141|B2|Baseline|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
751894|NCT01597141|B1|Baseline|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
751895|NCT01597141|P2|Participant Flow|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
751896|NCT01597141|P1|Participant Flow|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
751897|NCT01597141|O2|Outcome|Enhanced Standard Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
751898|NCT01597141|O1|Outcome|Family-aided Assertive Community Treatment|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
752023|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
751899|NCT01597141|O2|Outcome|Enhanced Treatment|"In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.~Enhanced standard treatment: In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention"
752097|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
751900|NCT01597141|O1|Outcome|Family-aided ACT|"The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.~Family-aided Assertive Community Treatment: The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication."
751901|NCT01597141|E2|Reported Event|Enhanced Standard Treatment|In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention.
751902|NCT01597141|E1|Reported Event|Family-aided Assertive Community Treatment|The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
751903|NCT01597128|B3|Baseline|Total|Total of all reporting groups
751904|NCT01597128|B2|Baseline|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751905|NCT01597128|B1|Baseline|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751906|NCT01597128|P2|Participant Flow|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751907|NCT01597128|P1|Participant Flow|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751908|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751909|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751910|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751911|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751912|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751913|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751914|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751915|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751916|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751917|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751918|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751919|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751920|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751921|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751922|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751923|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751924|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751925|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751926|NCT01597128|O2|Outcome|Strattice|Porcine Acellular Dermal Matrix: Strattice mesh for hernia repair
751927|NCT01597128|O1|Outcome|Flex HD|Human Acellular Dermal Matrix: Flex HD mesh for hernia repair
751928|NCT01597128|E2|Reported Event|Strattice|"Use of a second mesh type~Strattice: Strattice mash for hernia repair"
751929|NCT01597128|E1|Reported Event|Flex HD|"Mesh Type~Flex HD: Flex HD mesh for hernia repair"
751930|NCT01597050|B3|Baseline|Total|Total of all reporting groups
751931|NCT01597050|B2|Baseline|Placebo|"Placebo, bid~Placebo: Placebo, bid"
751932|NCT01597050|B1|Baseline|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
751933|NCT01597050|P2|Participant Flow|Placebo|"Placebo, bid~Placebo: Placebo, bid"
751934|NCT01597050|P1|Participant Flow|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
751935|NCT01597050|O2|Outcome|Placebo|"Placebo, bid~Placebo: Placebo, bid"
751936|NCT01597050|O1|Outcome|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
751937|NCT01597050|E2|Reported Event|Placebo|"Placebo, bid~Placebo: Placebo, bid"
751938|NCT01597050|E1|Reported Event|Drug: R932333|"R333 6% (60 mg/g), bid~R932333: R393233 6% (60 mg/g), bid"
751939|NCT01596972|B3|Baseline|Total|Total of all reporting groups
751940|NCT01596972|B2|Baseline|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
751941|NCT01596972|B1|Baseline|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
751942|NCT01596972|P2|Participant Flow|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
751958|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
752021|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
751960|NCT01596842|O1|Outcome|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751943|NCT01596972|P1|Participant Flow|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
751944|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
751945|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
751946|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
751947|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
751948|NCT01596972|O2|Outcome|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
751949|NCT01596972|O1|Outcome|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
751950|NCT01596972|E2|Reported Event|Serum hCG|follow-up consisting of a 1 week return visit and serum hCG plus standardized pregnancy symptom questionnaire
751951|NCT01596972|E1|Reported Event|Serum Quantitative Urine Pregnancy Test|"uterine evacuation follow-up consisting of an at-home, self-administered SQ-UPT and standardized pregnancy symptom questionnaire in 1 week~dBest semi-quantitative urine pregnancy test: The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)"
751952|NCT01596842|B3|Baseline|Total|Total of all reporting groups
751953|NCT01596842|B2|Baseline|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751954|NCT01596842|B1|Baseline|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751955|NCT01596842|P2|Participant Flow|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751956|NCT01596842|P1|Participant Flow|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751957|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751959|NCT01596842|O2|Outcome|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751961|NCT01596842|E2|Reported Event|Olive Oil|"Olive oil: Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751962|NCT01596842|E1|Reported Event|Omega-3 Fatty Acid|"Omega-3 fatty acid ethylester 90: Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks~cholecalciferol: if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks"
751963|NCT01596582|B3|Baseline|Total|Total of all reporting groups
751964|NCT01596582|B2|Baseline|Risk Assessment|"Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.~Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
751965|NCT01596582|B1|Baseline|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
751966|NCT01596582|P2|Participant Flow|Risk Assessment|"Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) and the ACNI risk assessment tool just prior to a scheduled office visit with their provider.~Risk Assessment: Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%)versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age 50-59,60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, >20 years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never)."
751967|NCT01596582|P1|Participant Flow|Standard Care|Subjects randomized to the control arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled visit with their provider.
751968|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
751969|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
751970|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
751971|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
751972|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
751973|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
751974|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
751975|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the experimental arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
751976|NCT01596582|O2|Outcome|Posttest|Provider responses to the same 3-item posttest administered after completion of study enrollment. Provider responses to a 3-item pretest administered prior the commencement of the study.
751977|NCT01596582|O1|Outcome|Pretest|Provider responses to a 3-item pretest administered prior the commencement of the study.
751978|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
751979|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
751980|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
751981|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
751982|NCT01596582|O2|Outcome|Discordance|The subgroup of patients who had a non-preferred test ordered, regardless of study arm or risk-category.
751983|NCT01596582|O1|Outcome|Concordance|The subgroup of patients who had their preferred test ordered, regardless of study arm or risk-category.
751984|NCT01596582|O2|Outcome|Low Risk|Patients with cumulative scores of less than 5 were classified as low risk, with a mean ACN rate of 3.1% (95% confidence interval [CI], 2.4% - 24.1%).
751985|NCT01596582|O1|Outcome|High Risk|Patients with cumulative ACNI scores of 5 to 12 were classified as intermediate/high risk (hereafter referred to as high risk), with a mean ACN rate of 8.3% (95% CI, 7.1% - 29.6%)
751986|NCT01596582|O2|Outcome|Risk Assessment|Subjects randomized to the experimental arm completed the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
751987|NCT01596582|O1|Outcome|Standard Care|Subjects randomized to the standard care arm reviewed the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
751988|NCT01596582|E2|Reported Event|Risk Assessment|Subjects randomized to the experimental arm will complete the ACNI risk assessment tool after reviewing the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
752235|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
751989|NCT01596582|E1|Reported Event|Standard Care|Subjects randomized to the experimental arm will review the web-based decision aid (http://www.colorectalcancerscreening4u.com) just prior to a scheduled office visit with their provider.
751990|NCT01596504|B4|Baseline|Total|Total of all reporting groups
751991|NCT01596504|B3|Baseline|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
751992|NCT01596504|B2|Baseline|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
751993|NCT01596504|B1|Baseline|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
751994|NCT01596504|P3|Participant Flow|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
751995|NCT01596504|P2|Participant Flow|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
751996|NCT01596504|P1|Participant Flow|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg once daily (QD) for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
751997|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
751998|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
751999|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752000|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752001|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752002|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752003|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752004|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752005|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752006|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752007|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752008|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752009|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752010|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752011|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752012|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752013|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752014|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752015|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752016|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752017|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752018|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752019|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752020|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752135|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752024|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752148|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752027|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752028|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752029|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752030|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752031|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752032|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752033|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752034|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752035|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752036|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752037|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752038|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752039|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752040|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752041|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752042|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752043|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752044|NCT01596504|O1|Outcome|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752045|NCT01596504|O3|Outcome|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752046|NCT01596504|O2|Outcome|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752047|NCT01596504|O1|Outcome|Lixisenatide 20 μg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752048|NCT01596504|E3|Reported Event|Liraglutide 1.8 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for another 1 week and 1.8 mg QD for next 6 weeks, on top of insulin glargine with or without metformin.
752049|NCT01596504|E2|Reported Event|Liraglutide 1.2 mg|Subcutaneous injection of liraglutide 0.6 mg QD for 1 week followed by 1.2 mg QD for 7 weeks, on top of insulin glargine with or without metformin.
752050|NCT01596504|E1|Reported Event|Lixisenatide 20 µg|Subcutaneous injection of lixisenatide10 μg QD for 2 weeks followed by 20 μg QD for 6 weeks, on top of insulin glargine with or without metformin.
752051|NCT01596231|B3|Baseline|Total|Total of all reporting groups
752052|NCT01596231|B2|Baseline|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
752053|NCT01596231|B1|Baseline|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
752054|NCT01596231|P2|Participant Flow|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
752055|NCT01596231|P1|Participant Flow|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
752056|NCT01596231|O2|Outcome|Kudzu|Kudzu extract treatment significantly reduced the number of beers opened and total amounts (weight and volume) consumed. Latency and time to consume a beer was not significantly altered, and there was no difference in the number of sips taken to drink a beer.
752057|NCT01596231|O1|Outcome|Placebo|Placebo did not alter alcohol consumption compared to baseline.
752058|NCT01596231|E2|Reported Event|Kudzu|"Kudzu 2mg~Kudzu: Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session."
752059|NCT01596231|E1|Reported Event|Placebo|"This is a study designed to test whether a single administration of kudzu extract (2 mg) or placebo will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session when given as a pretreatment 2 ½ hours before the drinking session.~Placebo: Placebo will be administered as a pretreatment 2 ½ hours before a drinking session"
752060|NCT01596088|B1|Baseline|Dexrazoxane|
752061|NCT01596088|P1|Participant Flow|Dexrazoxane|
752062|NCT01596088|O1|Outcome|Dexrazoxane|
752063|NCT01596088|E1|Reported Event|Dexrazoxane|
752064|NCT01596062|B4|Baseline|Total|Total of all reporting groups
752065|NCT01596062|B3|Baseline|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752066|NCT01596062|B2|Baseline|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752067|NCT01596062|B1|Baseline|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752068|NCT01596062|P3|Participant Flow|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752069|NCT01596062|P2|Participant Flow|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752070|NCT01596062|P1|Participant Flow|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752071|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752072|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752073|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752074|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752075|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752076|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752077|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752078|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752079|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752080|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752081|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752082|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752083|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752084|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752085|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752086|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752087|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752088|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752089|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752090|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752091|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752092|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752093|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752136|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752094|NCT01596062|O1|Outcome|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752095|NCT01596062|O3|Outcome|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752096|NCT01596062|O2|Outcome|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752149|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752098|NCT01596062|E3|Reported Event|Simulect 80mg + Certican + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Certican® + Myfortic® + corticosteroids
752099|NCT01596062|E2|Reported Event|Simulect 80mg + Neoral + Myfortic + Steroids|A cumulative dose of 80 mg of Simulect® (40mg at D0 and 40mg at D4) + Neoral® + Myfortic® + corticosteroids
752100|NCT01596062|E1|Reported Event|Simulect 40mg + Neoral + Myfortic + Steroids|A cumulative dose of 40 mg of Simulect® (20mg at Day 0 (D0) and 20mg at Day 4 (D4)+ Neoral® + Myfortic® + corticosteroids
752101|NCT01595854|B6|Baseline|Total|Total of all reporting groups
752102|NCT01595854|B5|Baseline|Dabigatran Etexilate / Multiple Dose Ticagrelor - Part 3|"A randomised two-period cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered with a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
752103|NCT01595854|B4|Baseline|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
752104|NCT01595854|B3|Baseline|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
752105|NCT01595854|B2|Baseline|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
752106|NCT01595854|B1|Baseline|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
752107|NCT01595854|P5|Participant Flow|Dabigatran Etexilate/Multiple Dose Ticagrelor Crossover-Part 3|"A randomised, two-period, cross-over trial, the two treatments administered were~A single dose of dabigatran etexilate 75 mg~Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.~Between treatment periods there was a washout period of at least 4 days."
752108|NCT01595854|P4|Participant Flow|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
752109|NCT01595854|P3|Participant Flow|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
752110|NCT01595854|P2|Participant Flow|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
752111|NCT01595854|P1|Participant Flow|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
752112|NCT01595854|O6|Outcome|Dabigatran + Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
752113|NCT01595854|O5|Outcome|Dabigatran 75 mg - Part 3|A single dose of Dabigatran etexilate 75 mg
752114|NCT01595854|O4|Outcome|Ticagrelor 180 mg - Part 2|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test.
752115|NCT01595854|O3|Outcome|Dabigatran 220 mg - Part 2|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
752116|NCT01595854|O2|Outcome|Ticagrelor 180 mg - Part 1|A single dose of Ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
752117|NCT01595854|O1|Outcome|Dabigatran 220 mg - Part 1|A single dose of Dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
752118|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (LD) ticagrelor.
752119|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
752120|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
752121|NCT01595854|O3|Outcome|Dabi + Ticagrelor MD|A single dose of 75 mg Dabigatran coadministered with a morning dose of multiple dose (MD) ticagrelor.
752122|NCT01595854|O2|Outcome|Dabi + Ticagrelor LD|A single dose of 75 mg Dabigatran coadministered with a loading dose (LD) of 180 mg ticagrelor coated tablets (T).
752123|NCT01595854|O1|Outcome|Dabi 75 mg|A single dose of Dabigatran etexilate (Dabi) 75 mg.
752124|NCT01595854|E6|Reported Event|Multiple Dose Ticagrelor - Part 3|Ticagrelor coated tablets dosed for four days; 180 mg loading dose on day 1, 90 mg twice daily on day 2 and 3, 90 mg on day 4. Co-administered is a single dose of 75 mg Dabigatran etexilate on days 1 and 4.
752125|NCT01595854|E5|Reported Event|Dabi 75 mg - Part 3|A single dose of dabigatran etexilate (Dabi) 75 mg
752126|NCT01595854|E4|Reported Event|Ticagrelor 180 mg - Part 2|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a shed blood test
752127|NCT01595854|E3|Reported Event|Dabigatran Etexilate 220 mg - Part 2|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a shed blood test.
752128|NCT01595854|E2|Reported Event|Ticagrelor 180 mg - Part 1|A single dose of ticagrelor coated tablets 180 mg (2 tablets of 90 mg), using a washed blood test.
752129|NCT01595854|E1|Reported Event|Dabigatran Etexilate 220 mg - Part 1|A single dose of dabigatran etexilate 220 mg (2 capsules of 110 mg), using a washed blood test.
752130|NCT01595438|B3|Baseline|Total|Total of all reporting groups
752131|NCT01595438|B2|Baseline|Doripenem|Doripenem treatment group
752132|NCT01595438|B1|Baseline|CAZ-AVI|Ceftazidime-avibactam treatment group
752133|NCT01595438|P2|Participant Flow|Doripenem|Doripenem treatment group
752134|NCT01595438|P1|Participant Flow|CAZ-AVI|Ceftazidime-avibactam treatment group
752139|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752140|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752141|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752142|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752143|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752144|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752145|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752146|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752147|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752154|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752155|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752156|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752157|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752158|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752159|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752160|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752161|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752162|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752163|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752164|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752165|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752166|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752167|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752168|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752169|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752170|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752171|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752172|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752173|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752174|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752175|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752176|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752177|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752178|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752179|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752180|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752181|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752182|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752183|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752184|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752185|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752186|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752187|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752188|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752189|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752190|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752191|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752192|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752193|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752194|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752195|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752196|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752197|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752198|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752199|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752200|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752201|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752202|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752203|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752204|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752205|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752206|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752207|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752208|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752209|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752210|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752211|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752212|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752213|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752214|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752215|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752216|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752217|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752218|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752219|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752220|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752221|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752222|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752223|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752224|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752225|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752226|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752227|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752228|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752229|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752230|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752231|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752232|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752233|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752234|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752236|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752237|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752238|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752239|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752240|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752241|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752242|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752243|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752244|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752245|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752246|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752247|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752248|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752249|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752250|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752251|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752252|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752253|NCT01595438|O2|Outcome|Doripenem|Doripenem treatment group
752254|NCT01595438|O1|Outcome|CAZ-AVI|Ceftazidime-avibactam treatment group
752255|NCT01595438|E2|Reported Event|Doripenem|Doripenem treatment group
752256|NCT01595438|E1|Reported Event|CAZ-AVI|Ceftazidime-avibactam treatment group
752257|NCT01595386|B3|Baseline|Total|Total of all reporting groups
752258|NCT01595386|B2|Baseline|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752259|NCT01595386|B1|Baseline|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752260|NCT01595386|P2|Participant Flow|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of cardiopulmonary bypass (CPB) and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752261|NCT01595386|P1|Participant Flow|Normal Saline|"The subjects will receive a bolus after successful completion of bypass and the post-pump adrenocorticotrophic hormone (ACTH) stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752262|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752263|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752264|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
754199|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
752265|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752266|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752324|NCT01594762|P2|Participant Flow|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
752588|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
752267|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752268|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752269|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752270|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752271|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752272|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752273|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752274|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752275|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752276|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752277|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752316|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
752317|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
752985|NCT01591616|O12|Outcome|Vital Signs (Systolic), 90 Minutes Post-dose|
752278|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752279|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752280|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752281|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752282|NCT01595386|O2|Outcome|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752283|NCT01595386|O1|Outcome|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752284|NCT01595386|E2|Reported Event|Hydrocortisone|"Subjects enrolled in this arm of the study will receive a 50mg/m2 bolus of Hydrocortisone after successful completion of CPB and the post-pump ACTH stim test has been performed. This will be followed by a continuous infusion of Hydrocortisone that will be tapered over the next 120 hours.~Hydrocortisone: The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off."
752285|NCT01595386|E1|Reported Event|Normal Saline-Placebo|"The subjects will receive a bolus after successful completion of bypass and the post-pump ACTH stim test equal to a 50mg/m2 dose of Hydrocortisone. This will be followed by a continuous infusion comparable to the rates a Hydrocortisone drip would run at. This infusion will be tapered down over the next 120 hours.~Normal Saline: This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm."
752286|NCT01595282|B3|Baseline|Total|Total of all reporting groups
752287|NCT01595282|B2|Baseline|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
752288|NCT01595282|B1|Baseline|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
752289|NCT01595282|P2|Participant Flow|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
752290|NCT01595282|P1|Participant Flow|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
752291|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
752318|NCT01594970|E3|Reported Event|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
752739|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752292|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
752293|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
752294|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
752295|NCT01595282|O2|Outcome|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
752296|NCT01595282|O1|Outcome|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
752297|NCT01595282|E2|Reported Event|Ibuprofen|"Ibuprofen 800 mg tablet -plus- intramuscular injection of 2cc saline placebo. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet -plus- intramuscular injection of 2cc saline placebo~Ibuprofen: For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure."
752298|NCT01595282|E1|Reported Event|Ketorolac|"Intramuscular injection of ketorolac 60 mg in 2cc -plus- placebo tablet (calcium carbonate 600 mg tablet). For subjects who are 50 kg or less, intramuscular injection of ketorolac 30 mg in 1cc -plus- placebo tablet (calcium carbonate 600 mg tablet)~Ketorolac: For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure"
752299|NCT01594970|B4|Baseline|Total|Total of all reporting groups
752300|NCT01594970|B3|Baseline|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
752301|NCT01594970|B2|Baseline|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
752302|NCT01594970|B1|Baseline|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
752303|NCT01594970|P3|Participant Flow|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
752304|NCT01594970|P2|Participant Flow|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
752305|NCT01594970|P1|Participant Flow|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
752306|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
752307|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
752308|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
752309|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
752310|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
752311|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
752312|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
752313|NCT01594970|O2|Outcome|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
752314|NCT01594970|O1|Outcome|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
752315|NCT01594970|O3|Outcome|Bimatoprost 0.01% (With Adjunctive Therapy)|1 drop in the affected eye(s), administered in the evening in subjects who are also receiving adjunctive therapy for 12 weeks.
752407|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752319|NCT01594970|E2|Reported Event|Bimatoprost 0.01% (Switched Monotherapy)|1 drop in the affected eye(s), administered in the evening in subjects who were previously on another monotherapy treatment for 12 weeks.
752320|NCT01594970|E1|Reported Event|Bimatoprost 0.01% (Naive Monotherapy)|1 drop in the affected eye(s), administered in the evening in previously treatment naive subjects for 12 weeks.
752321|NCT01594762|B3|Baseline|Total|Total of all reporting groups
752322|NCT01594762|B2|Baseline|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment~Standard wound care: 28-day trial period"
752323|NCT01594762|B1|Baseline|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment~Standard wound care: 28-day trial period"
752988|NCT01591616|O9|Outcome|Vital Signs (Systolic), 60 Minutes Post-dose|
752989|NCT01591616|O8|Outcome|Vital Signs (Systolic), 50 Minutes Post-dose|
752325|NCT01594762|P1|Participant Flow|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
752326|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
752327|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
752328|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
752329|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
752330|NCT01594762|O2|Outcome|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
752331|NCT01594762|O1|Outcome|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
752332|NCT01594762|E2|Reported Event|Topical Placebo Control|"Drug: Topical placebo cream~Topical placebo cream: 14 days of treatment"
752333|NCT01594762|E1|Reported Event|Topical Pexiganan Cream 0.8%|"Drug: Topical pexiganan cream 0.8%~Topical pexiganan cream 0.8%: 14 days of treatment"
752334|NCT01594749|B3|Baseline|Total|Total of all reporting groups
752335|NCT01594749|B2|Baseline|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752336|NCT01594749|B1|Baseline|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752337|NCT01594749|P2|Participant Flow|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752338|NCT01594749|P1|Participant Flow|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg intravenous (IV) infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, orally (PO) ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-hydroxytryptamine 3 (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752339|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752368|NCT01594515|P6|Participant Flow|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752369|NCT01594515|P5|Participant Flow|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752340|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752376|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752341|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752342|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752343|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752344|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752345|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752346|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752347|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752370|NCT01594515|P4|Participant Flow|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752371|NCT01594515|P3|Participant Flow|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752740|NCT01592760|E3|Reported Event|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752348|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752349|NCT01594749|O2|Outcome|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752350|NCT01594749|O1|Outcome|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752351|NCT01594749|E2|Reported Event|Control Regimen|On Day 1, participants received fosaprepitant placebo, 150 mL IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 20 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy; followed by 8 mg PO, 8 hours after the first dose. On Days 2-3, participants received ondansetron 8 mg, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752352|NCT01594749|E1|Reported Event|Fosaprepitant Regimen|On Day 1, participants received fosaprepitant, 150 mg IV infusion, ~30 minutes prior to chemotherapy PLUS dexamethasone 12 mg, PO ~30 minutes prior to chemotherapy PLUS ondansetron 16 mg total dose: 8 mg PO ~30-60 minutes prior to chemotherapy, followed by 8 mg PO, 8 hours after first dose PLUS dexamethasone placebo, PO ~30 minutes prior to chemotherapy. On Days 2 and 3, participants received ondansetron placebo, PO every 12 hours. Rescue Therapy: For established cases of nausea or vomiting, medications may have been prescribed from these permitted choices: 5-HT3 antagonists (granisetron, dolasetron, tropisetron or ondansetron); phenothiazines (e.g. prochlorperazine, fluphenazine, perphenazine, thiethylperazine, or chlorpromazine); butyrophenones (e.g. haloperidol or droperidol); benzamides (e.g. metoclopramide or alizapride); benzodiazepines; corticosteroids; domperidone.
752353|NCT01594515|B11|Baseline|Total|Total of all reporting groups
752354|NCT01594515|B10|Baseline|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752355|NCT01594515|B9|Baseline|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752356|NCT01594515|B8|Baseline|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752357|NCT01594515|B7|Baseline|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752358|NCT01594515|B6|Baseline|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752359|NCT01594515|B5|Baseline|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752360|NCT01594515|B4|Baseline|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752361|NCT01594515|B3|Baseline|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752362|NCT01594515|B2|Baseline|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752363|NCT01594515|B1|Baseline|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752364|NCT01594515|P10|Participant Flow|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752365|NCT01594515|P9|Participant Flow|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752366|NCT01594515|P8|Participant Flow|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752367|NCT01594515|P7|Participant Flow|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
754200|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
752372|NCT01594515|P2|Participant Flow|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752373|NCT01594515|P1|Participant Flow|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752374|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752375|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752377|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752378|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752379|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752380|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752381|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752382|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752383|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752384|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752385|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752386|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752387|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752388|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752389|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752390|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752391|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752392|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752393|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752394|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752395|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752396|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752397|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752398|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752399|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752400|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752401|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752402|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752403|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752404|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752405|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752406|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752741|NCT01592760|E2|Reported Event|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752408|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752409|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752410|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752411|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752412|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752413|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752414|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752415|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752416|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752417|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752418|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752419|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752420|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752421|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752422|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752423|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752424|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752425|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752426|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752427|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752428|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752429|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752430|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752431|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752432|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752433|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752434|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752435|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752436|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752437|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752438|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752439|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752440|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752441|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752442|NCT01594515|O10|Outcome|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752471|NCT01594411|O1|Outcome|No Tests/Treatment|Physician decision for no additional tests or cardiac treatment after receiving patients' GES
752443|NCT01594515|O9|Outcome|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752444|NCT01594515|O8|Outcome|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752445|NCT01594515|O7|Outcome|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752446|NCT01594515|O6|Outcome|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752447|NCT01594515|O5|Outcome|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752448|NCT01594515|O4|Outcome|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752449|NCT01594515|O3|Outcome|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752450|NCT01594515|O2|Outcome|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752451|NCT01594515|O1|Outcome|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752452|NCT01594515|E10|Reported Event|BI 1015550 High Dose 24mg|Single oral dose of 24mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752453|NCT01594515|E9|Reported Event|BI 1015550 High Dose 16mg|Single oral dose of 16mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752454|NCT01594515|E8|Reported Event|BI 1015550 Medium Dose 8mg|Single oral dose of 8mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752455|NCT01594515|E7|Reported Event|BI 1015550 Medium Dose 4mg|Single oral dose of 4mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752456|NCT01594515|E6|Reported Event|BI 1015550 Medium Dose 2mg|Single oral dose of 2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752457|NCT01594515|E5|Reported Event|BI 1015550 Low Dose 0.6mg|Single oral dose of 0.6mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752458|NCT01594515|E4|Reported Event|BI 1015550 Low Dose 0.2mg|Single oral dose of 0.2mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752459|NCT01594515|E3|Reported Event|BI 1015550 Low Dose 0.06mg|Single oral dose of 0.06mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752460|NCT01594515|E2|Reported Event|BI 1015550 Low Dose 0.02mg|Single oral dose of 0.02mg powder solution of BI 1015550 were administered once a day after an overnight fast to healthy male volunteers.
752461|NCT01594515|E1|Reported Event|Placebo|Single oral dose of placebo powder solution with matching volume were administered once a day after an overnight fast to healthy male volunteers.
752462|NCT01594424|B1|Baseline|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
752463|NCT01594424|P1|Participant Flow|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
752464|NCT01594424|O1|Outcome|IVIG + Tocilizumab (TCZ)|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
752465|NCT01594424|E1|Reported Event|IVIG + Tocilizumab|All patients received IVIg 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30) and TCZ (8 mg/kg administered on day 15, then monthly for 6 months). If transplanted, patients received IVIg on day 0; TCZ on day 2 and TCZ monthly for 6 months patients received alemtuzumab 30 mg subcutaneously x1 dose as induction and were maintained on triple regimen with tacrolimus (target level of 7 to 9 ng/mL in first 6 months; then 5-7 ng/mL between 6 and 12 months; then 3-5 ng/mL thereafter); mycophenolate mofetil and prednisone taper.
752466|NCT01594411|B1|Baseline|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
752467|NCT01594411|P1|Participant Flow|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
752468|NCT01594411|O4|Outcome|Invasive Angiography|Physician decision for invasive coronary angiography after receiving patients' GES
752469|NCT01594411|O3|Outcome|Stress Test|Physician decision for stress testing (with or without imaging) or computed tomography/coronary angiography after receiving patients' GES
752470|NCT01594411|O2|Outcome|Medical Therapy|Physician decision for lifestyle changes or medical therapy after receiving patients' GES
752472|NCT01594411|E1|Reported Event|All Subjects|Subjects are enrolled at multiple participating primary care practices. The main inclusion criterion for enrollment is the occurrence of chest pain (or anginal equivalent) in a patient without known significant CAD or a history of prior myocardial infarction.
752473|NCT01594385|B3|Baseline|Total|Total of all reporting groups
752474|NCT01594385|B2|Baseline|No Seprafilm|Patients in this group will not receive Seprafilm during re-operations. Otherwise, their surgical management will be identical to the Seprafilm Group.
752505|NCT01594125|P5|Participant Flow|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752990|NCT01591616|O7|Outcome|Vital Signs (Systolic), 40 Minutes Post-dose|
752475|NCT01594385|B1|Baseline|Seprafilm|"The treatment group will receive Seprafilm while the control group will not receive Seprafilm. Allocation of patients will be in approximately 1:1 ratio.~Seprafilm: Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:~Two Seprafilm pieces between the liver and the anterior abdominal wall~Four pieces over the exposed bowel surfaces anteriorly~Two slightly staggered pieces of Seprafilm in each colic gutter~Two pieces in the pelvic area.~If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair."
752476|NCT01594385|P2|Participant Flow|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
752477|NCT01594385|P1|Participant Flow|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
752478|NCT01594385|O2|Outcome|No Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.08 / 0.28 Operation #2 1.08 / 0.28 Operation #3 1.19 / 0.32 Operation #4 1.63 / 0.58 Operation #5 2.33 / 0.82 Operation #6 2.92 / 0.83 Operation #7 2.84 / 0.23
752479|NCT01594385|O1|Outcome|Seprafilm|Operation Number Zuhlke scores (mean / standard error) Operation #1 1.06 / 0.24 Operation #2 1.13 / 0.34 Operation #3 1.54 / 0.69 Operation #4 1.39 / 0.49 Operation #5 1.21 / 0.39 Operation #6 1.50 / 0.77 Operation #7 1.38 / 0.25
752480|NCT01594385|E2|Reported Event|No Seprafilm Group|Patients randomized to this group received no Seprafilm; Abdominal washout at the beginning of each procedure was performed in a fashion identical that in the Seprafilm Group.
752481|NCT01594385|E1|Reported Event|Seprafilm Group|Patient who randomized to this group received seprafilm at the end of each consecutive operation; Seprafilm from each previous operation was washed out at the beginning of each subsequent re-operation.
752482|NCT01594294|B3|Baseline|Total|Total of all reporting groups
752483|NCT01594294|B2|Baseline|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752484|NCT01594294|B1|Baseline|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752485|NCT01594294|P2|Participant Flow|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752486|NCT01594294|P1|Participant Flow|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752487|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752488|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752489|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752490|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752491|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752492|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752493|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752494|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752495|NCT01594294|O2|Outcome|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752496|NCT01594294|O1|Outcome|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752497|NCT01594294|E2|Reported Event|ReNu MultiPlus|ReNu MultiPlus® contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752498|NCT01594294|E1|Reported Event|AOSEPT Plus|AOSEPT® Plus contact lens solution used with etafilcon A contact lenses or lotrafilcon B contact lenses for 3 months (Investigational Phase)
752499|NCT01594125|B6|Baseline|Total|Total of all reporting groups
752500|NCT01594125|B5|Baseline|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752501|NCT01594125|B4|Baseline|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752502|NCT01594125|B3|Baseline|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752583|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752503|NCT01594125|B2|Baseline|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752504|NCT01594125|B1|Baseline|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
763043|NCT01545700|O8|Outcome|Dexamethasone 4 mg 0-4 Hours-2 Hours|
752506|NCT01594125|P4|Participant Flow|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752507|NCT01594125|P3|Participant Flow|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752508|NCT01594125|P2|Participant Flow|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752509|NCT01594125|P1|Participant Flow|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
752510|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752511|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752512|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752513|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752514|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
752515|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752516|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752517|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752518|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752519|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
752520|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752521|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752522|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752523|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752524|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
752525|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752526|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752584|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
754201|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
752527|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752528|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752529|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
752530|NCT01594125|O5|Outcome|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752531|NCT01594125|O4|Outcome|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752532|NCT01594125|O3|Outcome|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752533|NCT01594125|O2|Outcome|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752534|NCT01594125|O1|Outcome|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
752535|NCT01594125|E5|Reported Event|Group II: Nintedanib 200mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 200mg twice daily
752536|NCT01594125|E4|Reported Event|Group II: Nintedanib 150mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 x to <=5 upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 150mg twice daily
752537|NCT01594125|E3|Reported Event|Group II: Nintedanib 100mg Bid|Patients with moderate liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (>2 to <=5 x upper limit of normal (ULN)) and Child-Pugh B (score 7) treated with Nintedanib 100mg twice daily
752538|NCT01594125|E2|Reported Event|Group I: Nintedanib 200mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 200mg twice daily
752539|NCT01594125|E1|Reported Event|Group I: Nintedanib 150mg Bid|Patients with mild liver dysfunction according to their aspartate amino transferase (AST)/ alanine amino transferase (ALT) values (<=2 x upper limit of normal (ULN)) and Child-Pugh A treated with Nintedanib 150mg twice daily
752540|NCT01593852|B3|Baseline|Total|Total of all reporting groups
752541|NCT01593852|B2|Baseline|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752542|NCT01593852|B1|Baseline|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752543|NCT01593852|P2|Participant Flow|Regular X-ray Dose Settings|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752544|NCT01593852|P1|Participant Flow|Reduced X-ray Dose Settings|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752545|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752546|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752547|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752548|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752549|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752550|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752551|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752552|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752553|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
754202|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
752554|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752555|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752556|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752557|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752558|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752559|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752560|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752561|NCT01593852|O2|Outcome|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752562|NCT01593852|O1|Outcome|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752563|NCT01593852|E2|Reported Event|Regular X-ray Dose Settings (AlluraXper)|For patients in this group x-ray images are acquired with regular dose settings of the x-ray system and regular image processing
752564|NCT01593852|E1|Reported Event|Reduced X-ray Dose Settings (Allura Clarity)|"For patients in this group x-ray images are acquired with reduced dose settings of the x-ray system and advanced image processing~Advanced image processing : Acquisition of x-ray images with reduced X-ray dose and advanced image processing"
752565|NCT01593787|B4|Baseline|Total|Total of all reporting groups
752566|NCT01593787|B3|Baseline|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752567|NCT01593787|B2|Baseline|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752568|NCT01593787|B1|Baseline|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752569|NCT01593787|P3|Participant Flow|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752570|NCT01593787|P2|Participant Flow|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752571|NCT01593787|P1|Participant Flow|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752572|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
752573|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752574|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752575|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752576|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
752577|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752578|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752579|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752580|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
752581|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752582|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752585|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752586|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752587|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
763044|NCT01545700|O7|Outcome|Dexamethasone 4 mg 0-4 Hours-1 Hour|
752589|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752590|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752591|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752592|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
752593|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752594|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752595|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752596|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
752597|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752598|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752599|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752600|NCT01593787|O4|Outcome|Total LCZ696|All participants who received LCZ696
752601|NCT01593787|O3|Outcome|LCZ696 400 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who received LCZ696 200 mg and did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 4 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 400 mg.
752602|NCT01593787|O2|Outcome|LCZ696 200 mg|All participants were started on LCZ696 100 mg once daily on day 1. For participants who did not achieve msDBP <80 mmHg and msSBP <130 mmHg at or after week 2 and had no signs of safety concerns at specified visits during the treatment epoch, the LCZ696 dose was increased to LCZ696 200 mg.
752603|NCT01593787|O1|Outcome|LCZ696 100 mg|All participants were started on LCZ696 100 mg once daily on day 1.
752604|NCT01593787|E4|Reported Event|LCZ 200 mg|LCZ 200 mg
752605|NCT01593787|E3|Reported Event|Total LCZ696|All participants who received LCZ696
752606|NCT01593787|E2|Reported Event|LCZ 400 mg|LCZ 400 mg
752607|NCT01593787|E1|Reported Event|LCZ 100 mg|LCZ 100 mg
752608|NCT01593722|B3|Baseline|Total|Total of all reporting groups
752609|NCT01593722|B2|Baseline|SIngle Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752610|NCT01593722|B1|Baseline|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752611|NCT01593722|P2|Participant Flow|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752612|NCT01593722|P1|Participant Flow|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752613|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752614|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752615|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752616|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752617|NCT01593722|O2|Outcome|Single Dose IVM|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752618|NCT01593722|O1|Outcome|Single Dose DEC|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752619|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752620|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752621|NCT01593722|O2|Outcome|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752622|NCT01593722|O1|Outcome|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752623|NCT01593722|E2|Reported Event|Ivermectin|"ivermectin 200 mcg/kg single oral dose~Ivermectin: single dose"
752624|NCT01593722|E1|Reported Event|Diethylcarbamazine|"diethylcarbamazine 8 mg/kg single oral dose~Diethylcarbamazine: single dose"
752637|NCT01593592|P1|Participant Flow|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
752625|NCT01593670|B1|Baseline|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752991|NCT01591616|O6|Outcome|Vital Signs (Systolic), 30 Minutes Post-dose|
752626|NCT01593670|P1|Participant Flow|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752627|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752628|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752629|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752630|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752631|NCT01593670|O1|Outcome|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752632|NCT01593670|E1|Reported Event|Patients With High Risk MDS|"Patients who received treatment for high risk myelodysplastic syndromes (MDS). Treatment Received: Decitabine 10 mg/m^2/day intravenous (IV) over 1 hour days 1-5; Vorinostat 200 mg by mouth (PO) twice a day days 6-15; Il-2 activated donor natural killer cells (NK) infusion IV over 15 to 60 minutes day 17; Interleukin-2 6 million units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17. Repeat treatment course 6 to 8 weeks after cycle 1 start date.~Decitabine: administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.~Vorinostat: 200 mg by mouth (PO) twice a day on days 6-15~Interleukin-2: 6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17~Natural killer (NK) cells: infusion intravenously (IV) over 15 to 60 minutes day 17"
752633|NCT01593592|B3|Baseline|Total|Total of all reporting groups
752634|NCT01593592|B2|Baseline|Control Group|The control group that will receive the standard triple therapy and placebo
752635|NCT01593592|B1|Baseline|Lactobacillus Reuteri Group|The active group that will receive the standard triple therapy and Lactobacillus reuteri
752636|NCT01593592|P2|Participant Flow|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
752736|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752638|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
752667|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752639|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
752640|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
752641|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
752642|NCT01593592|O2|Outcome|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
752643|NCT01593592|O1|Outcome|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo : Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
752644|NCT01593592|E2|Reported Event|Control Group|"The control group that will receive the standard triple therapy and placebo~Placebo: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks."
752645|NCT01593592|E1|Reported Event|Lactobacillus Reuteri Group|"The active group that will receive the standard triple therapy and Lactobacillus reuteri~Lactobacillus reuteri: Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks."
752646|NCT01593215|B3|Baseline|Total|Total of all reporting groups
752647|NCT01593215|B2|Baseline|Yohimbine First Then Yohimbine|Yohimbine first and then placebo
752648|NCT01593215|B1|Baseline|Placebo First Then Yohimbine|"placebo first~Yohimbine: Yohimbine capsule"
752649|NCT01593215|P2|Participant Flow|Yohimbine First Then Placebo|Yohimbine first, 2 weeks washout and then placebo
752650|NCT01593215|P1|Participant Flow|Placebo First Then Yohimbine|Placebo first, then 2 weeks washout and then yohimbine
752651|NCT01593215|O2|Outcome|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
752652|NCT01593215|O1|Outcome|Placebo|"placebo~Yohimbine: Yohimbine capsule"
752653|NCT01593215|E2|Reported Event|Yohimbine|"Yohimbine~Yohimbine: Yohimbine capsule"
752654|NCT01593215|E1|Reported Event|Placebo|"placebo~Yohimbine: Yohimbine capsule"
752655|NCT01592864|B3|Baseline|Total|Total of all reporting groups
752656|NCT01592864|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752657|NCT01592864|B1|Baseline|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752658|NCT01592864|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752659|NCT01592864|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 milliliter (mL) of water.
752660|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752661|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752662|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752663|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752664|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752665|NCT01592864|O1|Outcome|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752666|NCT01592864|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752745|NCT01592708|B1|Baseline|Intervention Cohort|This arm was managed perioperatively with the protocol.
752992|NCT01591616|O5|Outcome|Vital Signs (Systolic), 20 Minutes Post-dose|
752668|NCT01592864|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice containing 0.76% NaMFP for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752669|NCT01592864|E1|Reported Event|SnF Dentifrice|Participants brushed whole mouth with 1-inch strip of the test dentifrice containing 0.454% SnF for one timed minute, ensuring that they brushed all sensitive areas of their teeth. This was followed by rinsing with 5 mL of water.
752670|NCT01592851|B3|Baseline|Total|Total of all reporting groups
752671|NCT01592851|B2|Baseline|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752672|NCT01592851|B1|Baseline|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752673|NCT01592851|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP) Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% Sodium Monofluorophosphate [NaMFP]) for one timed minute, followed by rinsing with 5 mL of water.
752674|NCT01592851|P1|Participant Flow|Stannous Fluoride (SnF) Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752675|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752676|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752677|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752678|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752679|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752680|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752681|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752682|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752683|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752684|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752685|NCT01592851|O2|Outcome|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752686|NCT01592851|O1|Outcome|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752687|NCT01592851|E2|Reported Event|NaMFP Dentifrice|Participants brushed whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.
752688|NCT01592851|E1|Reported Event|SnF Dentifrice|Participants brushed each of the 2 selected sensitive teeth for 30 seconds each, followed by the whole mouth with 1 inch strip of the test dentifrice (0.454% SnF) for at least 1 minute and rinsing with 5mL of water.
752689|NCT01592786|B1|Baseline|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
752690|NCT01592786|P1|Participant Flow|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg, or 15-mg per day, based upon patient weight.
752691|NCT01592786|O1|Outcome|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules once daily, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg per day, based upon patient weight.
752692|NCT01592786|E1|Reported Event|Memantine Hydrochloride (HCl)|Memantine Hydrochloride (HCl) extended-release 3-mg capsules, oral administration. Dosing was 3-mg, 6-mg, 9-mg, 12-mg or 15-mg, once per day, based upon patient weight.
752693|NCT01592773|B1|Baseline|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
752737|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752738|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752694|NCT01592773|P1|Participant Flow|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
763045|NCT01545700|O6|Outcome|Dexamethasone 4 mg 0-4 Hours-baseline|
752695|NCT01592773|O1|Outcome|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
752696|NCT01592773|E1|Reported Event|Memantine|"To maintain the blind of the preceding study, patients who participated in MEM-MD-68 began this study with 6 weeks of double blind dosing during which all patients were either titrated to or remained on their maximum target dosages. This was followed by up-to 42 weeks of open-label dosing.~Patients who took open-label memantine in the preceding study, MEM-MD-67 or MEM-MD-91, received up to 48 weeks of open-label memantine at their maximum tolerated weight based target dosage."
752697|NCT01592760|B4|Baseline|Total|Total of all reporting groups
752698|NCT01592760|B3|Baseline|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
752699|NCT01592760|B2|Baseline|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
752700|NCT01592760|B1|Baseline|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
752701|NCT01592760|P3|Participant Flow|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752702|NCT01592760|P2|Participant Flow|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752703|NCT01592760|P1|Participant Flow|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752704|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752705|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752706|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752707|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752708|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752709|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752710|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752711|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752712|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752713|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752714|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752715|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752716|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752717|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752718|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752719|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752720|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752721|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752722|NCT01592760|O3|Outcome|I-gel|"i-gel, sizes 3, 4, and 5 (Intersurgical Inc., Liverpool, NY, USA)~i-gel: i-gel placement for airway maintenance."
752723|NCT01592760|O2|Outcome|Air-Q|"air-Q Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q: air-Q placement for airway maintenance."
752724|NCT01592760|O1|Outcome|Air-Q SP|"air-Q Self-Pressurizing Intubating Laryngeal Airway, sizes 3.5 and 4.5 (Mercury Medical, Clearwater, FL, USA)~air-Q SP: air-Q SP placement for airway maintenance."
752725|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752726|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752727|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752728|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752729|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752730|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752731|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752732|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
752733|NCT01592760|O1|Outcome|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752734|NCT01592760|O3|Outcome|I-gel|Subjects randomized to receive an I-gel for airway maintenance under general anesthesia.
752735|NCT01592760|O2|Outcome|Air-Q SP|Subjects randomized to received an air-Q SP for airway maintenance under general anesthesia.
754203|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
752742|NCT01592760|E1|Reported Event|Air-Q|Subjects randomized to receive air-Q for airway maintenance under general anesthesia.
752743|NCT01592708|B3|Baseline|Total|Total of all reporting groups
752744|NCT01592708|B2|Baseline|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
763046|NCT01545700|O5|Outcome|Placebo 0-4 Hours-4 Hours|
752746|NCT01592708|P2|Participant Flow|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
752747|NCT01592708|P1|Participant Flow|Intervention Cohort|Patients undergoing maxillary surgery using antiemetic anesthesia protocol
752748|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
752749|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary
752750|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
752751|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
752752|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation, who completed the post-discharge diary
752753|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol who completed the post-discharge diary.
752754|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
752755|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
752756|NCT01592708|O2|Outcome|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
752757|NCT01592708|O1|Outcome|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthetic protocol
752758|NCT01592708|E2|Reported Event|Comparison Cohort|This arm was a retrospective comparison cohort treated at the same institution, managed per provider preference prior to protocol implementation.
752759|NCT01592708|E1|Reported Event|Intervention Cohort|Patients undergoing maxillary surgery using the antiemetic anesthesia protocol
752760|NCT01592435|B1|Baseline|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.~Carestream DR LLI software is investigational software used for reconstruction"
752761|NCT01592435|P1|Participant Flow|Pred. & Invest.-All Study Participants|"Cedera AccuStitch Software is standard of care software currently used at sites.~Carestream DR LLI software is investigational software used for reconstruction."
752762|NCT01592435|O1|Outcome|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
752763|NCT01592435|O1|Outcome|Predicate - Cedera AccuStitch Software|Cedera AccuStitch Software is standard of care software currently used at sites.
752764|NCT01592435|E2|Reported Event|Invest. - Carestream DR LLI Software|Carestream DR LLI software is investigational software used for reconstruction.
752765|NCT01592435|E1|Reported Event|Predicate - Cedera AccuStitch Software|Cedara Accustitch is the standard of care software currently used by sites.
752766|NCT01592396|B3|Baseline|Total|Total of all reporting groups
752767|NCT01592396|B2|Baseline|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752768|NCT01592396|B1|Baseline|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
752769|NCT01592396|P2|Participant Flow|Tralokinumab 300 mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752770|NCT01592396|P1|Participant Flow|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
752771|NCT01592396|O1|Outcome|Tralokinumab 300mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752772|NCT01592396|O1|Outcome|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752773|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752774|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
752775|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752776|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
752777|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752778|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
752779|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752980|NCT01591616|O17|Outcome|Vital Signs (Systolic), 140 Minutes Post-dose|
752981|NCT01591616|O16|Outcome|Vital Signs (Systolic), 130 Minutes Post-dose|
752780|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
752781|NCT01592396|O2|Outcome|Tralokinumab 300mg (Participants Aged 15-17 Years) - Cohort 2|Participants aged 15 to 17 years received a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
763047|NCT01545700|O4|Outcome|Placebo 0-4 Hours-3 Hours|
752782|NCT01592396|O1|Outcome|Tralokinumab 300 mg (Participants Aged 12-14 Years) - Cohort 1|Participants aged 12 to 14 years received a single dose of tralokinumab (CAT-354) 300 milligram (mg), subcutaneously on Day 1.
752783|NCT01592396|E1|Reported Event|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
752784|NCT01592344|B3|Baseline|Total|Total of all reporting groups
752785|NCT01592344|B2|Baseline|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
752786|NCT01592344|B1|Baseline|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
752787|NCT01592344|P2|Participant Flow|Control|Subjects implanted with the StimRouter lead and randomized to receive no electrical stimulation.
752788|NCT01592344|P1|Participant Flow|Active Stimulation Treatment|Subjects implanted with the StimRouter lead and randomized to receive active stimulation.
752789|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752790|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752791|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752792|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752793|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752794|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752795|NCT01592344|O2|Outcome|StimRouter - Control|"StimRouter- Electrical stimulation is withheld from the targeted peripheral nerve after fully implanting the StimRouter lead. The rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes is placed for transdermal stimulation but no stimulation is delivered. The EPT which normally receives radio frequency (RF) commands from a Patient Programmer is not activated. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer such that no stimulation occurs in the Control Arm of the study.~StimRouter - Control: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752982|NCT01591616|O15|Outcome|Vital Signs (Systolic), 120 Minutes Post-dose|
752820|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752993|NCT01591616|O4|Outcome|Vital Signs (Systolic), 10 Minutes Post-dose|
752994|NCT01591616|O3|Outcome|Vital Signs (Systolic), 0 Minutes Pre-dose|
752796|NCT01592344|O1|Outcome|StimRouter - Active Stimulation|"StimRouter- active electrical stimulation is applied transdermally to a targeted peripheral nerve. This is accomplished via a fully implanted StimRouter lead that receives energy from a rechargeable programmed external pulse transmitter (EPT) with attached gel electrodes. The EPT receives radio frequency (RF) commands from a Patient Programmer. A StimRouter Clinician Programmer is used to program the StimRouter EPT and Patient Programmer. Up to eight stimulation programs may be saved on a Patient Programmer for on-demand selection by the study patient.~StimRouter - active stimulation: The stimulation program settings for this arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752797|NCT01592344|E2|Reported Event|StimRouter Control|"The stimulation program settings for the control arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 200 µsec~Pulse Rate: 1 Hz~Intensity: 0 mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752798|NCT01592344|E1|Reported Event|StimRouter Active Stimulation|"The stimulation program settings for the active stimulation arm are as follows:~Stim Settings~Waveform: Symmetric or Asymmetric~Phase Duration: 100-250 µsec~Pulse Rate: 50-100 Hz~Intensity: 0-30mA Time Settings~Constant Stim: On~Total Time: 6 hour"
752799|NCT01592292|B3|Baseline|Total|Total of all reporting groups
752800|NCT01592292|B2|Baseline|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752801|NCT01592292|B1|Baseline|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752802|NCT01592292|P4|Participant Flow|Other Anti-TNF Agent: Infliximab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving infliximab as per physician’s discretion for RA treatment were observed for 12 months.
752803|NCT01592292|P3|Participant Flow|Other Anti-TNF Agent: Etanercept|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving etanercept as per physician’s discretion for RA treatment were observed for 12 months.
752804|NCT01592292|P2|Participant Flow|Other Anti-TNF Agent: Adalimumab|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving adalimumab as per physician’s discretion for RA treatment were observed for 12 months.
752805|NCT01592292|P1|Participant Flow|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752806|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752807|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752808|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752809|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752810|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752811|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752812|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752813|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752814|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752815|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752816|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752817|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752818|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752819|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752821|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752822|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752823|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752824|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752825|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752826|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752827|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752828|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752829|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752830|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752831|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752832|NCT01592292|O2|Outcome|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752833|NCT01592292|O1|Outcome|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752834|NCT01592292|E2|Reported Event|Other Anti-TNF Agent|Participants who have inadequate response or were intolerant to the first anti-TNF agent in RA, receiving other anti-TNF agent (adalimumab, etanercept or infliximab) as per physician’s discretion for RA treatment were observed for 12 months.
752835|NCT01592292|E1|Reported Event|Rituximab|Participants who have inadequate response or were intolerant to the first anti-tumor necrosis factor (anti-TNF) agent in rheumatoid arthritis (RA), receiving rituximab as per physician’s discretion for RA treatment were observed for 12 months.
752836|NCT01592071|B1|Baseline|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752837|NCT01592071|P1|Participant Flow|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752838|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752839|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752840|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752841|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752983|NCT01591616|O14|Outcome|Vital Signs (Systolic), 110 Minutes Post-dose|
754204|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
752892|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
763056|NCT01545700|O1|Outcome|Placebo 0-4 Hours|Placebo 0-4 hours baseline
752842|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752843|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752844|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752845|NCT01592071|O1|Outcome|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752846|NCT01592071|E1|Reported Event|Non-reactive Foods|Subjects had blood drawn for proprietary test known as the Immuno Bloodprint. Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements. The primary advice to each participant was to focus as much as possible on eliminating the reactive foods from the diet for a 90-day period.
752847|NCT01592045|B3|Baseline|Total|Total of all reporting groups
752848|NCT01592045|B2|Baseline|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
752849|NCT01592045|B1|Baseline|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
752850|NCT01592045|P2|Participant Flow|Sequence 2|"NCI ch14.18 for two courses followed by UTC ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
752851|NCT01592045|P1|Participant Flow|Sequence 1|"UTC ch14.18 for two courses followed by NCI ch14.18 for three courses~ch14.18 -NCI: 25 mg/m^2/day IV for four consecutive days~ch14.18-UTC: 17.5 mg/m^2/day IV for four consecutive days~Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF): GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.~Aldesleukin (IL-2): Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.~Isotretinoin: Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
752852|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
752853|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
752854|NCT01592045|O2|Outcome|NCI ch14.18|NCI Manufactured ch14.18
752855|NCT01592045|O1|Outcome|UTC ch14.18|United Therapeutics Manufactured ch14.18
752856|NCT01592045|E2|Reported Event|NCI ch14.18|NCI Manufactured ch14.18
752857|NCT01592045|E1|Reported Event|UTC ch14.18|United Therapeutics Manufactured ch14.18
752858|NCT01592006|B1|Baseline|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
752859|NCT01592006|P1|Participant Flow|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
752860|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
752861|NCT01592006|O1|Outcome|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
752862|NCT01592006|E1|Reported Event|HCV, LT, Pegasys, Ribavirin, Telaprevir|Patients will be treated with Pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week, Ribavirin 800-1200 mg PO per day (weight-based) for 48 weeks. Telaprevir 750 mg PO tid will be administered for the first 12 weeks. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
752863|NCT01591954|B1|Baseline|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
752864|NCT01591954|P1|Participant Flow|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
752865|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
752866|NCT01591954|O1|Outcome|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
752867|NCT01591954|E1|Reported Event|Video Augmentation|"Qualitative assessment of the value of video-based navigation system~Video Augmentation: Assessment of value of video-based navigation system"
752868|NCT01591863|B1|Baseline|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752869|NCT01591863|P1|Participant Flow|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752870|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752871|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752872|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752873|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752874|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752875|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752876|NCT01591863|O1|Outcome|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752877|NCT01591863|E1|Reported Event|Fidaxomicin|"fidaxomicin: 6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
752878|NCT01591837|B3|Baseline|Total|Total of all reporting groups
752879|NCT01591837|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752880|NCT01591837|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752881|NCT01591837|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752882|NCT01591837|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752883|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752884|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752885|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752886|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752887|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752888|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752889|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752890|NCT01591837|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752891|NCT01591837|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752984|NCT01591616|O13|Outcome|Vital Signs (Systolic), 100 Minutes Post-dose|
752893|NCT01591837|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752894|NCT01591837|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years received a single 0.5 mL dose of CSL Influenza Vaccine by intramuscular or subcutaneous injection.
752895|NCT01591681|B1|Baseline|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
752896|NCT01591681|P1|Participant Flow|Randomized Nights- Treatment or Control|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
752897|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752898|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752899|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752900|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752901|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752902|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752903|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752904|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752905|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752906|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752907|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752908|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752909|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752910|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752911|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752912|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752913|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752914|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752915|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
754205|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
752986|NCT01591616|O11|Outcome|Vital Signs (Systolic) 80 Minutes Post-dose|
752987|NCT01591616|O10|Outcome|Vital Signs (Systolic), 70 Minutes Post-dose|
752916|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752917|NCT01591681|O2|Outcome|Standard of Care|The control algorithm will run passively and not recommend control the patient's pump.
752918|NCT01591681|O1|Outcome|Pump Suspension Algorithm|"The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend.~Pump suspension: The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend."
752919|NCT01591681|E2|Reported Event|Standard of Care|On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump.
752920|NCT01591681|E1|Reported Event|Pump Suspension Algorithm|Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.)
752921|NCT01591616|B1|Baseline|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
752922|NCT01591616|P1|Participant Flow|Oraqix for Tooth Extraction|lidocaine and prilocaine: Appropriate dose of Oraqix based on weight will be given before tooth extraction
752923|NCT01591616|O4|Outcome|QTcB Interval, 4 Hour Post-dose|
752924|NCT01591616|O3|Outcome|QTcB Interval, 2 Hour Post-dose|
752925|NCT01591616|O2|Outcome|QTcB Interval, 1 Hour Post-dose|
752926|NCT01591616|O1|Outcome|QTcB Interval, Pre-dose|
752927|NCT01591616|O4|Outcome|QT Interval, 4 Hour Post-dose|
752928|NCT01591616|O3|Outcome|QT Interval, 2 Hour Post-dose|
752929|NCT01591616|O2|Outcome|QT Interval, 1 Hour Post-dose|
752930|NCT01591616|O1|Outcome|QT Interval, Pre-dose|
752931|NCT01591616|O4|Outcome|QRS Duration, 4 Hour Post-dose|
752932|NCT01591616|O3|Outcome|QRS Duration, 2 Hour Post-dose|
752933|NCT01591616|O2|Outcome|QRS Duration, 1 Hour Post-dose|
752934|NCT01591616|O1|Outcome|QRS Duration, Pre-dose|
752935|NCT01591616|O4|Outcome|PR Interval, 4 Hour Post-dose|
752936|NCT01591616|O3|Outcome|PR Interval, 2 Hour Post-dose|
752937|NCT01591616|O2|Outcome|PR Interval, 1 Hour Post-dose|
752938|NCT01591616|O1|Outcome|PR Interval, Pre-dose|
752939|NCT01591616|O4|Outcome|Ventricular Heart Rate, 4 Hour Post-dose|
752940|NCT01591616|O3|Outcome|Ventricular Heart Rate, 2 Hour Post-dose|
752941|NCT01591616|O2|Outcome|Ventricular Heart Rate, 1 Hour Post-dose|
752942|NCT01591616|O1|Outcome|Ventricular Heart Rate, Pre-dose|
752943|NCT01591616|O27|Outcome|Vital Signs (Diastolic), 240 Minutes Post-dose|
752944|NCT01591616|O26|Outcome|Vital Signs (Diastolic), 230 Minutes Post-dose|
752945|NCT01591616|O25|Outcome|Vital Signs (Diastolic), 220 Minutes Post-dose|
752946|NCT01591616|O24|Outcome|Vital Signs (Diastolic), 210 Minutes Post-dose|
752947|NCT01591616|O23|Outcome|Vital Signs (Diastolic), 200 Minutes Post-dose|
752948|NCT01591616|O22|Outcome|Vital Signs (Diastolic), 190 Minutes Post-dose|
752949|NCT01591616|O21|Outcome|Vital Signs (Diastolic), 180 Minutes Post-dose|
752950|NCT01591616|O20|Outcome|Vital Signs (Diastolic), 170 Minutes Post-dose|
752951|NCT01591616|O19|Outcome|Vital Signs (Diastolic), 160 Minutes Post-dose|
752952|NCT01591616|O18|Outcome|Vital Signs (Diastolic), 150 Minutes Post-dose|
752953|NCT01591616|O17|Outcome|Vital Signs (Diastolic), 140 Minutes Post-dose|
752954|NCT01591616|O16|Outcome|Vital Signs Diastolic(), 130 Minutes Post-dose|
752955|NCT01591616|O15|Outcome|Vital Signs (Diastolic), 120 Minutes Post-dose|
752956|NCT01591616|O14|Outcome|Vital Signs (Diastolic), 110 Minutes Post-dose|
752957|NCT01591616|O13|Outcome|Vital Signs (Diastolic), 100 Minutes Post-dose|
752958|NCT01591616|O12|Outcome|Vital Signs (Diastolic), 90 Minutes Post-dose|
752959|NCT01591616|O11|Outcome|Vital Signs (Diastolic) 80 Minutes Post-dose|
752960|NCT01591616|O10|Outcome|Vital Signs (Diastolic), 70 Minutes Post-dose|
752961|NCT01591616|O9|Outcome|Vital Signs Diastolic(), 60 Minutes Post-dose|
752962|NCT01591616|O8|Outcome|Vital Signs (Diastolic), 50 Minutes Post-dose|
752963|NCT01591616|O7|Outcome|Vital Signs (Diastolic), 40 Minutes Post-dose|
752964|NCT01591616|O6|Outcome|Vital Signs (Diastolic), 30 Minutes Post-dose|
752965|NCT01591616|O5|Outcome|Vital Signs (Diastolic), 20 Minutes Post-dose|
752966|NCT01591616|O4|Outcome|Vital Signs (Diastolic), 10 Minutes Post-dose|
752967|NCT01591616|O3|Outcome|Vital Signs (Diastolic), 0 Minutes Pre-dose|
752968|NCT01591616|O2|Outcome|Vital Signs (Diastolic), - 10 Minutes Pre-dose|
752969|NCT01591616|O1|Outcome|Vital Signs (Diastolic), - 20 Minutes Pre-dose|
752970|NCT01591616|O27|Outcome|Vital Signs (Systolic), 240 Minutes Post-dose|
752971|NCT01591616|O26|Outcome|Vital Signs (Systolic), 230 Minutes Post-dose|
752972|NCT01591616|O25|Outcome|Vital Signs (Systolic), 220 Minutes Post-dose|
752973|NCT01591616|O24|Outcome|Vital Signs (Systolic), 210 Minutes Post-dose|
752974|NCT01591616|O23|Outcome|Vital Signs (Systolic), 200 Minutes Post-dose|
752975|NCT01591616|O22|Outcome|Vital Signs (Systolic), 190 Minutes Post-dose|
752976|NCT01591616|O21|Outcome|Vital Signs (Systolic), 180 Minutes Post-dose|
752977|NCT01591616|O20|Outcome|Vital Signs (Systolic), 170 Minutes Post-dose|
752978|NCT01591616|O19|Outcome|Vital Signs (Systolic), 160 Minutes Post-dose|
752979|NCT01591616|O18|Outcome|Vital Signs (Systolic), 150 Minutes Post-dose|
752995|NCT01591616|O2|Outcome|Vital Signs (Systolic), - 10 Minutes Pre-dose|
752996|NCT01591616|O1|Outcome|Vital Signs (Systolic), - 20 Minutes Pre-dose|
752997|NCT01591616|O27|Outcome|Vital Signs (Pulse Rate), 240 Minutes Post-dose|
752998|NCT01591616|O26|Outcome|Vital Signs (Pulse Rate), 230 Minutes Post-dose|
752999|NCT01591616|O25|Outcome|Vital Signs (Pulse Rate), 220 Minutes Post-dose|
753000|NCT01591616|O24|Outcome|Vital Signs (Pulse Rate), 210 Minutes Post-dose|
753001|NCT01591616|O23|Outcome|Vital Signs (Pulse Rate), 200 Minutes Post-dose|
753002|NCT01591616|O22|Outcome|Vital Signs (Pulse Rate), 190 Minutes Post-dose|
753003|NCT01591616|O21|Outcome|Vital Signs (Pulse Rate), 180 Minutes Post-dose|
753004|NCT01591616|O20|Outcome|Vital Signs (Pulse Rate), 170 Minutes Post-dose|
753005|NCT01591616|O19|Outcome|Vital Signs (Pulse Rate), 160 Minutes Post-dose|
753006|NCT01591616|O18|Outcome|Vital Signs (Pulse Rate), 150 Minutes Post-dose|
753007|NCT01591616|O17|Outcome|Vital Signs (Pulse Rate), 140 Minutes Post-dose|
753008|NCT01591616|O16|Outcome|Vital Signs (Pulse Rate), 130 Minutes Post-dose|
753009|NCT01591616|O15|Outcome|Vital Signs (Pulse Rate), 120 Minutes Post-dose|
753010|NCT01591616|O14|Outcome|Vital Signs (Pulse Rate), 110 Minutes Post-dose|
753011|NCT01591616|O13|Outcome|Vital Signs (Pulse Rate), 100 Minutes Post-dose|
753012|NCT01591616|O12|Outcome|Vital Signs (Pulse Rate), 90 Minutes Post-dose|
753013|NCT01591616|O11|Outcome|Vital Signs (Pulse Rate), 80 Minutes Post-dose|
753014|NCT01591616|O10|Outcome|Vital Signs (Pulse Rate), 70 Minutes Post-dose|
753015|NCT01591616|O9|Outcome|Vital Signs (Pulse Rate), 60 Minutes Post-dose|
753016|NCT01591616|O8|Outcome|Vital Signs (Pulse Rate), 50 Minutes Post-dose|
753017|NCT01591616|O7|Outcome|Vital Signs (Pulse Rate), 40 Minutes Post-dose|
753018|NCT01591616|O6|Outcome|Vital Signs (Pulse Rate), 30 Minutes Post-dose|
753019|NCT01591616|O5|Outcome|Vital Signs (Pulse Rate), 20 Minutes Post-dose|
753020|NCT01591616|O4|Outcome|Vital Signs (Pulse Rate), 10 Minutes Post-dose|
753021|NCT01591616|O3|Outcome|Vital Signs (Pulse Rate), 0 Minutes Pre-dose|
753022|NCT01591616|O2|Outcome|Vital Signs (Pulse Rate), - 10 Minutes Pre-dose|
753023|NCT01591616|O1|Outcome|Vital Signs (Pulse Rate), - 20 Minutes Pre-dose|
753024|NCT01591616|O4|Outcome|O-toluidine Tmax|
753025|NCT01591616|O3|Outcome|2,6-xylidine Tmax|
753026|NCT01591616|O2|Outcome|Prilocaine Tmax|
753027|NCT01591616|O1|Outcome|Lidocaine Tmax|
753028|NCT01591616|O27|Outcome|% MetHemoglobin (MetHb) Time Point 240 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753029|NCT01591616|O26|Outcome|% MetHemoglobin (MetHb) Time Point 230 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753030|NCT01591616|O25|Outcome|% MetHemoglobin (MetHb) Time Point 220 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753031|NCT01591616|O24|Outcome|% MetHemoglobin (MetHb) Time Point 210 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753032|NCT01591616|O23|Outcome|% MetHemoglobin (MetHb) Time Point 200 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753033|NCT01591616|O22|Outcome|% MetHemoglobin (MetHb) Time Point 190 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753034|NCT01591616|O21|Outcome|% MetHemoglobin (MetHb) Time Point 180 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753035|NCT01591616|O20|Outcome|% MetHemoglobin (MetHb) Time Point 170 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753036|NCT01591616|O19|Outcome|% MetHemoglobin (MetHb) Time Point 160 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753037|NCT01591616|O18|Outcome|% MetHemoglobin (MetHb) Time Point 150 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753038|NCT01591616|O17|Outcome|% MetHemoglobin (MetHb) Time Point 140 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753039|NCT01591616|O16|Outcome|% MetHemoglobin (MetHb) Time Point 130 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753040|NCT01591616|O15|Outcome|% MetHemoglobin (MetHb) Time Point 120 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753041|NCT01591616|O14|Outcome|% MetHemoglobin (MetHb) Time Point 110 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
754206|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
753042|NCT01591616|O13|Outcome|% MetHemoglobin (MetHb) Time Point 100 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753043|NCT01591616|O12|Outcome|% MetHemoglobin (MetHb) Time Point 90 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753044|NCT01591616|O11|Outcome|% MetHemoglobin (MetHb) Time Point 80 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753079|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
753045|NCT01591616|O10|Outcome|% MetHemoglobin (MetHb) Time Point 70 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753046|NCT01591616|O9|Outcome|% MetHemoglobin (MetHb) Time Point 60 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753047|NCT01591616|O8|Outcome|% MetHemoglobin (MetHb) Time Point 50 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753048|NCT01591616|O7|Outcome|% MetHemoglobin (MetHb) Time Point 40 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753049|NCT01591616|O6|Outcome|% MetHemoglobin (MetHb) Time Point 30 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753050|NCT01591616|O5|Outcome|% MetHemoglobin (MetHb) Time Point 20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753051|NCT01591616|O4|Outcome|% MetHemoglobin (MetHb) Time Point 10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753052|NCT01591616|O3|Outcome|% MetHemoglobin (MetHb) Time Point 0 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753053|NCT01591616|O2|Outcome|% MetHemoglobin (MetHb) Time Point -10 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753054|NCT01591616|O1|Outcome|% MetHemoglobin (MetHb) Time Point -20 Minutes|The % MetHb levels were measured at pre-dose (-20, -10 and 0 min prior to Oraqix administration) and every 10 minutes up to 240 minutes post dose.
753055|NCT01591616|O4|Outcome|O-toluidine Cmax|
753056|NCT01591616|O3|Outcome|2,6-xylidine Cmax|
753057|NCT01591616|O2|Outcome|Prilocaine Cmax|
753058|NCT01591616|O1|Outcome|Lidocaine Cmax|
753059|NCT01591616|E1|Reported Event|Adverse Events|
753060|NCT01591499|B3|Baseline|Total|Total of all reporting groups
753061|NCT01591499|B2|Baseline|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision or Purevision crossover to Biofinity)
753062|NCT01591499|B1|Baseline|Biofinity/Air Optix Aqua Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix or Air Optix crossover to Biofinity)
753063|NCT01591499|P4|Participant Flow|Purevision Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
753064|NCT01591499|P3|Participant Flow|Biofinity Then Purevision|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
753065|NCT01591499|P2|Participant Flow|Air Optix Then Biofinity|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
753066|NCT01591499|P1|Participant Flow|Biofinity Then Air Optix|"Randomized cross-over study to wear Biofinity Multifocal lenses or to wear either the Air Optix Aqual Multiocal lens (lenses allocated on a ratio of 1/0.5) or the PureVision Multifocal lens (lenses allocated on a ratio of 1/0.5).~First pair of lens evaluated and worn up to 24 days. Subjects are crossed over to second pair of lens. Second pair of lens evaluated and worn up to 24 days."
753067|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair
753068|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
753069|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
753070|NCT01591499|O3|Outcome|Evaluated At Least One Lens|Population of patients having evaluated at least one lens pair.
753071|NCT01591499|O2|Outcome|Biofinity/Purevision Combination|Participants were randomized to wear either a Biofinity pair or an Purevision pair and then crossed over to the alternate lens pair. (Biofinity crossover to Purevision) (Purevision crossover to Biofinity
753072|NCT01591499|O1|Outcome|Biofinity/Air Optix Combination|Participants were randomized to wear either a Biofinity pair or an Air Optix pair and then crossed over to the alternate lens pair. (Biofinity crossover to Air Optix) (Air Optix crossover to Biofinity)
753073|NCT01591499|O3|Outcome|Purevision Multifocal|Clinical performance by lens (Purevision Multifocal)
753458|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
753074|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Clinical performance by lens (Air Optix Aqua Multifocal)
753075|NCT01591499|O1|Outcome|Biofinity Multifocal|Clinical performance by lens (Biofinity Multifocal) tested at V3 or V5
753076|NCT01591499|O3|Outcome|Purevision Multifocal|Geometric performance by lens (Purevision Multifocal)
753077|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
753078|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
753080|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Geometric performance by lens (Air Optix Aqua Multifocal)
753081|NCT01591499|O1|Outcome|Biofinity Multifocal|Geometric performance by lens (Biofinity Multifocal) tested at V3 or V5
753082|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
753083|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
753084|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
753085|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
753086|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
753087|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
753088|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
753089|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
753090|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
753091|NCT01591499|O3|Outcome|Purevision Multifocal|Performance by lens (Purevision Multifocal)
753092|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Performance by lens (Air Optix Aqua Multifocal)
753093|NCT01591499|O1|Outcome|Biofinity Multifocal|Performance by lens (Biofinity Multifocal) tested at V3 or V5
753094|NCT01591499|O3|Outcome|Purevision Multifocal|Comfort performance by lens (Purevision Multifocal)
753095|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Comfort performance by lens (Air Optix Aqua Multifocal)
753096|NCT01591499|O1|Outcome|Biofinity Multifocal|Comfort performance by lens (Biofinity Multifocal) tested at V3 or V5
753097|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753098|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753099|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
753100|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753101|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753102|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
753103|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753104|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753105|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
753106|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753107|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753108|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
753109|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753110|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753111|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
753112|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753113|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753114|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
753115|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753116|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753117|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
753118|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753119|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753120|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
753121|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753122|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753123|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at visit V3 or V5
753124|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753125|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753126|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal)
753127|NCT01591499|O3|Outcome|Purevision Multifocal|Visual performance by lens (Purevision Multifocal)
753128|NCT01591499|O2|Outcome|Air Optix Aqua Multifocal|Visual performance by lens (Air Optix Aqua Multifocal)
753129|NCT01591499|O1|Outcome|Biofinity Multifocal|Visual performance by lens (Biofinity Multifocal) tested at V3 or V5
753130|NCT01591499|E1|Reported Event|Overall Study Population|Population of patients having evaluated at least one lens
753225|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753140|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753238|NCT01591317|B3|Baseline|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
753131|NCT01591460|B1|Baseline|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753132|NCT01591460|P1|Participant Flow|Total Population|Treatment-naive participants with chronic hepatitis C (CHC) received treatment with peginterferon alfa-2a (PEG-IFN) 180 micrograms (mcg) subcutaneous (SC) once weekly, weight-based ribavirin (RBV) 1000 to 1200 milligrams (mg) orally (PO) daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a less than (<) 1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753133|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753134|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753135|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753136|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753137|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753138|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753139|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753226|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753141|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753142|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753143|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753144|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753145|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753146|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753147|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753148|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753149|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753150|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753227|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753459|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
753151|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753152|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753153|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753154|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753155|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753156|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753157|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753158|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753159|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753160|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753161|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753228|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753162|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753354|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753163|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753164|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753165|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753166|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753167|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753168|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753169|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753170|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753171|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753172|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753229|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753460|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
753195|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753173|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753174|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753175|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753176|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753177|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753178|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753179|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753180|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753181|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753182|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753183|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753230|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753231|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753232|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753184|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753185|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753186|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753187|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753188|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753189|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753190|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753191|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753192|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753193|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753194|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753233|NCT01591382|O2|Outcome|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753196|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753197|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753198|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753199|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753200|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753201|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753202|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753203|NCT01591460|O6|Outcome|Others|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those not meeting criteria for the other treatment groups (Cirrhotics, Poor Responders, Late Responders, or Early Responders) were classified separately (as Others) and were not treated per response-guided therapy.
753204|NCT01591460|O5|Outcome|Early Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with undetectable HCV RNA at Weeks 8 and 24 (Early Responders) stopped treatment at Week 28.
753205|NCT01591460|O4|Outcome|Late Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 (Late Responders) continued triple therapy until Week 36 and received dual therapy from Week 36 to 48.
753234|NCT01591382|O1|Outcome|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753349|NCT01590888|P2|Participant Flow|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753235|NCT01591382|E2|Reported Event|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753236|NCT01591382|E1|Reported Event|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753237|NCT01591317|B4|Baseline|Total|Total of all reporting groups
753355|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753206|NCT01591460|O3|Outcome|Poor Responders|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Those without cirrhosis and with a <1-log decrease in HCV RNA at Week 4 (Poor Responders) continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated.
753207|NCT01591460|O2|Outcome|Cirrhotics|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Response-guided treatment was determined by assessments of virologic response at Weeks 4, 8, and 24. Participants with compensated cirrhosis (Cirrhotics), regardless of response, received triple therapy until Week 48.
753208|NCT01591460|O1|Outcome|Total Population|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48.
753209|NCT01591460|E2|Reported Event|Noncirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants without liver cirrhosis, including those with transition to cirrhosis, were grouped separately in the safety analysis.
753210|NCT01591460|E1|Reported Event|Cirrhotics (Safety)|Treatment-naive participants with CHC received treatment with PEG-IFN 180 mcg SC once weekly, weight-based RBV 1000 to 1200 mg PO daily in 2 divided doses, and boceprevir 800 mg PO every 7 to 9 hours. Participants received dual therapy with PEG-IFN and RBV from Week 0 to 4, and triple therapy was initiated at Week 4. Those with undetectable HCV RNA at Weeks 8 and 24 stopped treatment at Week 28. Those with detectable HCV RNA at Week 8 but undetectable HCV RNA at Week 24 continued triple therapy until Week 36 and received dual therapy from Week 36 to 48. Those with a <1-log decrease in HCV RNA at Week 4 continued triple therapy until Week 48, with optional dual therapy from Week 32 to 48 if triple therapy was not tolerated. Participants with compensated cirrhosis, regardless of response, received triple therapy until Week 48. Participants with liver cirrhosis were grouped separately in the safety analysis.
753211|NCT01591408|B3|Baseline|Total|Total of all reporting groups
753212|NCT01591408|B2|Baseline|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753213|NCT01591408|B1|Baseline|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753214|NCT01591408|P2|Participant Flow|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753215|NCT01591408|P1|Participant Flow|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753216|NCT01591408|O2|Outcome|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753217|NCT01591408|O1|Outcome|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753218|NCT01591408|E2|Reported Event|Sham EEG Biofeedback|"Subjects will receive feedback according to someone else's brain rhythms collected during a different session.~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753219|NCT01591408|E1|Reported Event|EEG Biofeedback|"Subjects will receive EEG biofeedback according to their own brain rhythms~EEG biofeedback: EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues."
753220|NCT01591382|B3|Baseline|Total|Total of all reporting groups
753221|NCT01591382|B2|Baseline|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753222|NCT01591382|B1|Baseline|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753223|NCT01591382|P2|Participant Flow|Placebo|Hydromorphone PCA and placebo-matching ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753224|NCT01591382|P1|Participant Flow|Ketamine|Hydromorphone PCA and ketamine intravenous (IV) infusion 0.2 mg/kg/hr for 24-48 hours postoperatively.
753239|NCT01591317|B2|Baseline|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
753240|NCT01591317|B1|Baseline|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
753241|NCT01591317|P3|Participant Flow|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
753242|NCT01591317|P2|Participant Flow|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
753243|NCT01591317|P1|Participant Flow|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
753244|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
753245|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
753246|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
753247|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
753248|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
753249|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
753250|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
753251|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
753252|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
753253|NCT01591317|O3|Outcome|Prasugrel 5 mg|Prasugrel 5 mg once a day orally for 10 days
753254|NCT01591317|O2|Outcome|Prasugrel 7.5 mg|Prasugrel 7.5 mg once a day orally for 10 days
753255|NCT01591317|O1|Outcome|Prasugrel 10 mg|Prasugrel 10 mg once a day orally for 10 days
753256|NCT01591317|O3|Outcome|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
753257|NCT01591317|O2|Outcome|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
753258|NCT01591317|O1|Outcome|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
753259|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
753260|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
753261|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
753262|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
753263|NCT01591317|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg loading dose given once orally
753264|NCT01591317|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg loading dose given once orally
753265|NCT01591317|E3|Reported Event|Prasugrel - 30 mg/5 mg|Prasugrel 30 mg loading dose given once orally followed by 5 mg once a day orally for 10 days
753266|NCT01591317|E2|Reported Event|Prasugrel - 30 mg/7.5 mg|Prasugrel 30 mg loading dose given once orally, followed by 7.5 mg once a day orally for 10 days
753267|NCT01591317|E1|Reported Event|Prasugrel - 60 mg/10 mg|Prasugrel 60 mg loading dose given once orally, followed by 10 mg once a day orally for 10 days
753268|NCT01591044|B4|Baseline|Total|Total of all reporting groups
753269|NCT01591044|B3|Baseline|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753270|NCT01591044|B2|Baseline|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
753271|NCT01591044|B1|Baseline|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753272|NCT01591044|P3|Participant Flow|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753273|NCT01591044|P2|Participant Flow|Placebo|Placebo: 1 puff bid or 2 puffs bid
753274|NCT01591044|P1|Participant Flow|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753275|NCT01591044|O3|Outcome|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753276|NCT01591044|O2|Outcome|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
753277|NCT01591044|O1|Outcome|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753278|NCT01591044|E3|Reported Event|R940343 1mg, 1 Puff Bid|"R343 1mg, 1 puff bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753279|NCT01591044|E2|Reported Event|Placebo|Placebo: 1, 1 puff bid or 2, 2 puffs bid
753280|NCT01591044|E1|Reported Event|R940343 2mg, 2 Puffs Bid|"R343 2mg, 2 puffs bid~R940343: R343 1mg, 1 puff bid R343 2mg, 2 puffs bid"
753281|NCT01591018|B3|Baseline|Total|Total of all reporting groups
753282|NCT01591018|B2|Baseline|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753283|NCT01591018|B1|Baseline|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753284|NCT01591018|P2|Participant Flow|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753346|NCT01590888|B2|Baseline|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753347|NCT01590888|B1|Baseline|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753285|NCT01591018|P1|Participant Flow|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753315|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753286|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753287|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753288|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753289|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753290|NCT01591018|O2|Outcome|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753291|NCT01591018|O1|Outcome|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753292|NCT01591018|E2|Reported Event|Cardiac Surgery Without Sonolysis|"cardiac surgery (CABG or heart valve surgery) without sonolysis (continual transcranial Doppler monitoring)~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753293|NCT01591018|E1|Reported Event|Cardiac Surgery With Sonolysis|"cardiac surgery (CABG or heart valve surgery) with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes~cardiac surgery: coronary artery bypass graft (CABG) heart valve replacement"
753294|NCT01591005|B5|Baseline|Total|Total of all reporting groups
753295|NCT01591005|B4|Baseline|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753296|NCT01591005|B3|Baseline|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753297|NCT01591005|B2|Baseline|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753298|NCT01591005|B1|Baseline|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753299|NCT01591005|P4|Participant Flow|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753300|NCT01591005|P3|Participant Flow|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753301|NCT01591005|P2|Participant Flow|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753302|NCT01591005|P1|Participant Flow|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753303|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753304|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753305|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753306|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753307|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753308|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753309|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753310|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753311|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753312|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753313|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753348|NCT01590888|P3|Participant Flow|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753449|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
753314|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753316|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753317|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753318|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753319|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753320|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753321|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753322|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753323|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753324|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753325|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753326|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753327|NCT01591005|O4|Outcome|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753328|NCT01591005|O3|Outcome|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753329|NCT01591005|O2|Outcome|Carotid Endarterectomy Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753330|NCT01591005|O1|Outcome|Carotid Endarterectomy With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753331|NCT01591005|E4|Reported Event|Carotid Stenting Without Sonolysis|"carotid stenting without sonolysis~carotid stenting: percutaneous transluminal angioplasty and stenting"
753332|NCT01591005|E3|Reported Event|Carotid Stenting With Sonolysis|"carotid stenting with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~carotid stenting: percutaneous transluminal angioplasty and stenting"
753333|NCT01591005|E2|Reported Event|CEA Without Sonolysis|"endarterectomy without sonolysis~endarterectomy: carotid endarterectomy"
753334|NCT01591005|E1|Reported Event|CEA With Sonolysis|"endarterectomy with sonolysis (continual transcranial Doppler monitoring)~sonolysis: continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes~endarterectomy: carotid endarterectomy"
753335|NCT01590979|B3|Baseline|Total|Total of all reporting groups
753336|NCT01590979|B2|Baseline|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
753337|NCT01590979|B1|Baseline|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
753338|NCT01590979|P2|Participant Flow|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
753339|NCT01590979|P1|Participant Flow|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
753340|NCT01590979|O2|Outcome|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
753341|NCT01590979|O1|Outcome|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
753342|NCT01590979|E2|Reported Event|Placebo|"Company generated placebo, will be similar in size and color to Ranolazine; and administered two times a day (12 hour intervals)~Placebo: two times a day, 12 hour intervals"
753343|NCT01590979|E1|Reported Event|Ranolazine|"The antianginal properties of the drug are due to inhibition of the late inward sodium current, demonstrated in animal experiments and human studies that it can prevent atrial and ventricular arrhythmias.~Ranolazine: 1000mg, two times a day, 12 hour intervals"
753344|NCT01590888|B4|Baseline|Total|Total of all reporting groups
753345|NCT01590888|B3|Baseline|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753350|NCT01590888|P1|Participant Flow|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753351|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753352|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753353|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753356|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753357|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753358|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753359|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753360|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753361|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753362|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753363|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753364|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753365|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753366|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753367|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753368|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753369|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753370|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753371|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753372|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753373|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753374|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753375|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753376|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753377|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753378|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753379|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753380|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753381|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753382|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753383|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753384|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753385|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753386|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753387|NCT01590888|O3|Outcome|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753388|NCT01590888|O2|Outcome|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753389|NCT01590888|O1|Outcome|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753390|NCT01590888|E3|Reported Event|Sugar Pill|Placebo: Matching capsules administered orally once per day for 26 weeks
753391|NCT01590888|E2|Reported Event|PBT2 100mg|PBT2: 100mg capsules administered orally once per day for 26 weeks
753392|NCT01590888|E1|Reported Event|PBT2 250mg|PBT2: 250mg capsules administered orally once per day for 26 weeks
753393|NCT01590875|B3|Baseline|Total|Total of all reporting groups
753394|NCT01590875|B2|Baseline|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
753395|NCT01590875|B1|Baseline|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
753396|NCT01590875|P2|Participant Flow|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
753450|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
753451|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
753452|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
753453|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
753454|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
753397|NCT01590875|P1|Participant Flow|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
753398|NCT01590875|O2|Outcome|Observation Arm|10 patients were be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
753399|NCT01590875|O1|Outcome|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients without pulmonary vein reconnection after initial dose.
753400|NCT01590875|O2|Outcome|Observation Arm|10patients were randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
753401|NCT01590875|O1|Outcome|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients that did not demonstrate pulmonary vein reconnection after initial dose.
753402|NCT01590875|O2|Outcome|Observation Arm|"10 patients were randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.~Of these 10 patients, none demonstrated pulmonary vein reconnection during the 10 minute period of observation."
753403|NCT01590875|O1|Outcome|Adenosine Arm|"10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given only if no reconnection after initial dose.~Of these 10 patients, 3 patients were noted to have pulmonary vein reconnection post initial dose of adenosine in at least one pulmonary vein. No patient demonstrated pulmonary vein reconnection with second dose of adenosine."
753404|NCT01590875|O2|Outcome|Observation Arm|25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This will serve as the control arm.
753405|NCT01590875|O1|Outcome|Adenosine Arm|"25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose.~Adenosine arm: In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation."
753406|NCT01590875|E2|Reported Event|Observation Arm|10 patients were be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation. This served as the control arm.
753407|NCT01590875|E1|Reported Event|Adenosine Arm|10 patients were randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, we monitored for pulmonary vein reconnection, second dose of adenosine was given to the 7 patients without reconnection after initial dose.
753408|NCT01590810|B6|Baseline|Total|Total of all reporting groups
753409|NCT01590810|B5|Baseline|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
753410|NCT01590810|B4|Baseline|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
753411|NCT01590810|B3|Baseline|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
753412|NCT01590810|B2|Baseline|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
753455|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
753456|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
753457|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
753413|NCT01590810|B1|Baseline|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
753467|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
753414|NCT01590810|P5|Participant Flow|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
753415|NCT01590810|P4|Participant Flow|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
753416|NCT01590810|P3|Participant Flow|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
753417|NCT01590810|P2|Participant Flow|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
753418|NCT01590810|P1|Participant Flow|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
753419|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
753420|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
753421|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
753422|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
753423|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
753424|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
753425|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
753426|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
753427|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
753428|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
753429|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
753430|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
753431|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
753432|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
753433|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
753434|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
753435|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
753436|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
753437|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
753438|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
753439|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
753440|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
753441|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
753442|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
753443|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
753444|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
753445|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
753446|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
753447|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
753448|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
753462|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
753463|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
753464|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
753465|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
753466|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
753468|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
753469|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
753470|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
753471|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
753472|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
753473|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
753474|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
753475|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
753476|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
753477|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
753478|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
753479|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
753480|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
753481|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
753482|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
753483|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
753484|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
753485|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
753486|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
753487|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
753488|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
753489|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
753490|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
753491|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
753492|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
753493|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
753494|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
753495|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
753496|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
753497|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
753498|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
753499|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
753500|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
753501|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
753502|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
753503|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
753504|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
753505|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
753506|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
753507|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
753508|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
753509|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
753510|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
753511|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
753512|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
753513|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
753514|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
753515|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
753516|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
753517|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
753518|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
753519|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
753520|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
753521|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
753522|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
753523|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
753524|NCT01590810|O5|Outcome|Panel D – Placebo|Single dose of placebo
753525|NCT01590810|O4|Outcome|Panel D – MK-8150 200 mg|Single dose of MK-8150 200 mg
753526|NCT01590810|O3|Outcome|Panel D – MK-8150 100 mg|Single dose of MK-8150 100 mg
753527|NCT01590810|O2|Outcome|Panel D – MK-8150 50 mg (Repeat Dose)|Single dose of MK-8150 50 mg. This was a repeat administration of the 50 mg dose, permitted under flexible design of protocol
753528|NCT01590810|O1|Outcome|Panel D – MK-8150 50 mg|Single dose of MK-8150 50 mg
753529|NCT01590810|O4|Outcome|Panel C – Placebo|Single dose of placebo
753530|NCT01590810|O3|Outcome|Panel C – MK-8150 90 mg|Single dose of MK-8150 90 mg
753531|NCT01590810|O2|Outcome|Panel C – MK-8150 24 mg|Single dose of MK-8150 24 mg
753532|NCT01590810|O1|Outcome|Panel C – MK-8150 5 mg|Single dose of MK-8150 5 mg
753533|NCT01590810|O6|Outcome|Panel B – Placebo|Single dose of placebo
753534|NCT01590810|O5|Outcome|Panel B – MK-8150 120 mg (Repeat Dose)|Single dose of MK-8150 120 mg. This was a repeat administration of the 120 mg dose, permitted under flexible design of protocol
753535|NCT01590810|O4|Outcome|Panel B – MK-8150 120 mg|Single dose of MK-8150 120 mg
753536|NCT01590810|O3|Outcome|Panel B – MK-8150 45 mg|Single dose of MK-8150 45 mg
753537|NCT01590810|O2|Outcome|Panel B – MK-8150 12 mg|Single dose of MK-8150 12 mg
753538|NCT01590810|O1|Outcome|Panel B – MK-8150 4 mg|Single dose of MK-8150 4 mg
753539|NCT01590810|O6|Outcome|Panel A – Placebo|Single dose of placebo
753540|NCT01590810|O5|Outcome|Panel A – MK-8150 90 mg|Single dose of MK-8150 90 mg
753541|NCT01590810|O4|Outcome|Panel A – MK-8150 24 mg (Fed Condition)|Single dose of MK-8150 24 mg, administered following a standard high-fat breakfast (Fed condition). MK-8150 24 mg doses in this Panel A period were the only doses in study administered after a meal. All other doses in study were administered after an overnight fast.
753542|NCT01590810|O3|Outcome|Panel A – MK-8150 24 mg|Single dose of MK-8150 24 mg
753543|NCT01590810|O2|Outcome|Panel A – MK-8150 6 mg|Single dose of MK-8150 6 mg
753544|NCT01590810|O1|Outcome|Panel A – MK-8150 2 mg|Single dose of MK-8150 2 mg
753545|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
753546|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
753547|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
753548|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
753549|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
753550|NCT01590810|O5|Outcome|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
753551|NCT01590810|O4|Outcome|Panel D – MK-8150 50 to 200 mg|Description: Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
753567|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
754207|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
753552|NCT01590810|O3|Outcome|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
753553|NCT01590810|O2|Outcome|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
753554|NCT01590810|O1|Outcome|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
753555|NCT01590810|E5|Reported Event|Panel D – Placebo|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered placebo.
753556|NCT01590810|E4|Reported Event|Panel D – MK-8150 50 to 200 mg|Within Panel D, 8 healthy participants were randomly assigned to receive single doses of MK-8150, and 2 were randomly assigned to receive single administrations of matching placebo throughout the up to 5 treatment periods according to a computer-generated allocation schedule (i.e., assignment of a participant to either MK-8150 or placebo was fixed for all Panel D periods). This reporting group presents data for the Panel D participants administered MK-8150. The dose range of MK-8150 administered for Panel D was 50 mg to 200 mg.
753557|NCT01590810|E3|Reported Event|Panel C – MK-8150 5 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel C, 6 participants with mild to moderate hypertension were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel C was 5 mg to 90 mg.
753558|NCT01590810|E2|Reported Event|Panel B – MK-8150 4 to 120 mg/Placebo|Within each of the up to 5 treatment periods in Panel B, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel B was 4 mg to 120 mg.
753559|NCT01590810|E1|Reported Event|Panel A – MK-8150 2 to 90 mg/Placebo|Within each of the up to 5 treatment periods in Panel A, 6 healthy participants were randomly assigned to receive a single dose of MK-8150, and 2 were randomly assigned to receive single administration of matching placebo according to a computer-generated allocation schedule. By protocol allocation schedule participants did not have fixed assignment to single dose MK-8150 or placebo for all treatment periods, but were reallocated from one treatment period to the next, so that a participant could receive both MK-8150 and placebo, in different periods of the Panel. The dose range of MK-8150 administered for Panel A was 2 mg to 90 mg.
753560|NCT01590797|B3|Baseline|Total|Total of all reporting groups
753561|NCT01590797|B2|Baseline|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753562|NCT01590797|B1|Baseline|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753563|NCT01590797|P2|Participant Flow|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753564|NCT01590797|P1|Participant Flow|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753565|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753566|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753871|NCT01588548|P5|Participant Flow|AZD1208 700mg|Once daily continuous dosing schedule.
753568|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753569|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753570|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753571|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753572|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753573|NCT01590797|O2|Outcome|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753574|NCT01590797|O1|Outcome|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753575|NCT01590797|E2|Reported Event|Placebo|Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753576|NCT01590797|E1|Reported Event|Sitagliptin|Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
753577|NCT01590771|B3|Baseline|Total|Total of all reporting groups
753578|NCT01590771|B2|Baseline|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753579|NCT01590771|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753580|NCT01590771|P2|Participant Flow|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753581|NCT01590771|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753582|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753583|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753584|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753585|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753586|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753587|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753588|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753589|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753590|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753591|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753592|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753593|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753594|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753595|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753596|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753597|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753598|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753599|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753600|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753601|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753602|NCT01590771|O2|Outcome|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753603|NCT01590771|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753604|NCT01590771|E2|Reported Event|Placebo|Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753605|NCT01590771|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
753606|NCT01590758|B3|Baseline|Total|Total of all reporting groups
753607|NCT01590758|B2|Baseline|Topical Placebo Control|"Topical placebo cream: 14 days of treatment~Standard wound care: 28-day trial period"
753608|NCT01590758|B1|Baseline|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment~Standard wound care: 28-day trial period"
753609|NCT01590758|P2|Participant Flow|Topical Placebo Control|"Topical placebo cream: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
753610|NCT01590758|P1|Participant Flow|Topical Pexiganan Cream 0.8%|"Topical pexiganan cream 0.8%: 14 days of treatment + 14 days of follow-up (28-day trial period)~Standard wound care: 28-day trial period"
753611|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
753612|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
753613|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
753614|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
753615|NCT01590758|O2|Outcome|Topical Placebo Control|Topical placebo cream: 14 days of treatment
753616|NCT01590758|O1|Outcome|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
753617|NCT01590758|E2|Reported Event|Topical Placebo Control|Topical placebo cream: 14 days of treatment
753618|NCT01590758|E1|Reported Event|Topical Pexiganan Cream 0.8%|Topical pexiganan cream 0.8%: 14 days of treatment
753619|NCT01590563|B1|Baseline|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
753620|NCT01590563|P1|Participant Flow|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
753621|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
753622|NCT01590563|O1|Outcome|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
753623|NCT01590563|O1|Outcome|Investigated Device Group|Group inserted the investigated device - the IUB SCu300A
753624|NCT01590563|E1|Reported Event|SCu300A IUB|Insertion of a spherical IUD (intrauterine device) with one year follow-up
753625|NCT01590550|B1|Baseline|Observational|All patients receiving acute HD during the study period
753626|NCT01590550|P1|Participant Flow|Observational|All patients receiving acute HD during the study period
753627|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
753628|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period
753629|NCT01590550|O1|Outcome|Observational|All patients receiving acute HD during the study period 6/118 (5%) treatments with circuit or catheter clotting
753630|NCT01590550|E1|Reported Event|Observational|All patients receiving acute HD during the study period
753631|NCT01590264|B1|Baseline|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
753632|NCT01590264|P1|Participant Flow|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
753633|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
753634|NCT01590264|O1|Outcome|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
753635|NCT01590264|E1|Reported Event|Bimodal rTMS|"Open-label and single-arm rTMS bimodal treatment with placement of magnet over Dorsolateral Prefrontal Cortex (DLPFC) and Temporoparietal Junction (TPJ) for 2 weeks of treatment (10 days)~Stimulation Settings:~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
753636|NCT01590238|B1|Baseline|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
753637|NCT01590238|P1|Participant Flow|Treatment With PRFM|"Subjects treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
753638|NCT01590238|O1|Outcome|Treatment With PRFM|Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured (6 months after initial treatment) and compared to hair density index measured prior to treatment for each subject.
753639|NCT01590238|E1|Reported Event|Treatment With PRFM|"Subjects with androgenetic alopecia clinically diagnosed were treated monthly 3 times with intradermal injections of PRFM into bald/balding scalp. Post-treatment hair density index measured and compared to hair density index measured prior to treatment for each subject.~PRFM treatment: Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment."
753640|NCT01590212|B4|Baseline|Total|Total of all reporting groups
753641|NCT01590212|B3|Baseline|Care as Usual (CAU)|Participants received care in line with local guidelines.
753642|NCT01590212|B2|Baseline|Chill-out in Pregnancy (CHiP) + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
753643|NCT01590212|B1|Baseline|Mellow Bumps (MB) + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers’ understanding of neonates’ capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks’ gestation.
753644|NCT01590212|P3|Participant Flow|Care as Usual|"Care-as-usual comprises routine antenatal care provided by the NHS in line with local guidelines.~Services provided as part of an individividual woman's care plan. If indicated, a pre-birth case conference is held at 28-32 weeks."
753645|NCT01590212|P2|Participant Flow|Chill-out in Pregnancy + Care as Usual|"Chill-out in Pregnancy is a targeted intervention aimed at pregnant women with additional health and social care needs.~It is a stress-reduction programme which includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship elements.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
753646|NCT01590212|P1|Participant Flow|Mellow Bumps + Care as Usual|"Mellow Bumps is a targeted intervention aimed at pregnant women with additional health and social care needs.~Underpinned by attachment theory, there is a focus on:~Improving maternal wellbeing by reducing stress and anxiety Increasing expectant mother's understandings of neonates' capacity for social interaction Emphasising the importance of early interaction to enhance brain development and attachment.~Groups meet every week for six weeks when the women is between 20 and 30 weeks pregnant."
753647|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
753648|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
753649|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
753650|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
753651|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
753652|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
753653|NCT01590212|O3|Outcome|Care as Usual|Participants received care in line with local guidelines
753654|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
753655|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
753656|NCT01590212|O3|Outcome|Care as Usual|All participants received care in line with local guidelines.
753657|NCT01590212|O2|Outcome|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
753658|NCT01590212|O1|Outcome|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
753659|NCT01590212|E3|Reported Event|Care as Usual|Participants received care in line with local guidelines
753660|NCT01590212|E2|Reported Event|Chill-out in Pregnancy + Care as Usual|CHiP is a relaxation programme that includes all the mother-centred components of Mellow Bumps but none of the baby or mother-baby relationship components. It runs for six weeks at two hours per week. It aims to decrease maternal stress levels.
753661|NCT01590212|E1|Reported Event|Mellow Bumps + Care as Usual|MB is a six week group-based antenatal programme designed to support families with additional health and social care needs. MB is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation.
753662|NCT01589978|B1|Baseline|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753663|NCT01589978|P1|Participant Flow|PROMUS Element Overall Population|"Subjects who receive the PROMUS Element everolimus-eluting coronary stent.~Subgroups within the Overall Population Group:~PLATINUM-Like Patients N=776 (at time of Primary endpoint)~Defined as: all patients without acute MI, graft stenting, CTO, ISR, failed brachytherapy, bifurcation, ostial lesion, severe tortuosity, moderate or severe calcification by visual estimate in target lesion or target vessel proximal to target lesion, three-vessel stenting, cardiogenic shock, left main disease, or acute or chronic renal dysfunction (serum creatinine >2.0 mg/dl or patient on dialysis). For PLATINUM-like patients, lesion length and RVD should meet one of two criteria: 1) lesion length ≤28 mm and diameter ≥2.25 mm and <2.5 mm, or 2) lesion length ≤24 mm and diameter ≥2.5 mm and ≤4.25 mm.~Long Lesion Patients N=340 Defined as: patients treated with at least one 32mm or 38mm (excluding patients only treated with 2.25 mm diameter and 32 mm length WH stent size) study stent."
753664|NCT01589978|O1|Outcome|PROMUS Element Overall Population|Subjects who receive the PROMUS Element everolimus-eluting coronary stent.
753665|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753666|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753667|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753668|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753669|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753670|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753671|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753672|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753673|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753674|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753675|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753676|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753677|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753678|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753679|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753680|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753681|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753682|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753683|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753684|NCT01589978|O1|Outcome|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753685|NCT01589978|E1|Reported Event|PROMUS Element|Subjects who receive the PROMUS Element everolimus-eluting coronary stent
753687|NCT01589822|B3|Baseline|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
753688|NCT01589822|B2|Baseline|Standard of Care|Standard surgical technique for GI anastomosis.
753689|NCT01589822|B1|Baseline|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
753690|NCT01589822|P3|Participant Flow|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative"
753691|NCT01589822|P2|Participant Flow|Standard of Care|Standard surgical technique for GI anastomosis.
753692|NCT01589822|P1|Participant Flow|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative"
753693|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753694|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
753695|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753696|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753697|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
753698|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753699|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753700|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
753701|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753702|NCT01589822|O3|Outcome|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753703|NCT01589822|O2|Outcome|Standard of Care|Standard surgical technique for GI anastomosis. (IIT)
753704|NCT01589822|O1|Outcome|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (IIT)"
753705|NCT01589822|E3|Reported Event|Experimental: EVICEL Fibrin Sealant: Non-Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753706|NCT01589822|E2|Reported Event|Standard of Care|Standard surgical technique for GI anastomosis. (Safety Set)
753707|NCT01589822|E1|Reported Event|EVICEL Fibrin Sealant: Randomized|"EVICEL is a human plasma-derived fibrin sealant composed of two components - thrombin and fibrinogen.~EVICEL Fibrin Sealant: Intraoperative (Safety Set)"
753708|NCT01589653|B3|Baseline|Total|Total of all reporting groups
753709|NCT01589653|B2|Baseline|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753710|NCT01589653|B1|Baseline|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753711|NCT01589653|P2|Participant Flow|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753712|NCT01589653|P1|Participant Flow|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753713|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753714|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753715|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753716|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753872|NCT01588548|P4|Participant Flow|AZD1208 540mg|Once daily continuous dosing schedule.
753717|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753718|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753881|NCT01588548|O1|Outcome|AZD1208 120mg|Once daily continuous dosing schedule.
753882|NCT01588548|E6|Reported Event|AZD1208 800mg|Once daily continuous dosing schedule.
753719|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753720|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753721|NCT01589653|O2|Outcome|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753722|NCT01589653|O1|Outcome|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753723|NCT01589653|E2|Reported Event|Investigator-driven Titration|The subjects received BIAsp 30. The treatment dose was adjusted according to the directions given by the investigator. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753724|NCT01589653|E1|Reported Event|Subject-driven Titration|The subjects received BIAsp 30. The treatment dose was individually adjusted by the subjects themselves according to the titration algorithm every second week. Trial product was administered subcutaneously (s.c., under the skin) twice daily.
753725|NCT01589510|B1|Baseline|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753726|NCT01589510|P1|Participant Flow|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753727|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753728|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753729|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753730|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753731|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753732|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753733|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753734|NCT01589510|O1|Outcome|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753735|NCT01589510|E1|Reported Event|Lumigan® 0.01%|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) as prescribed by physician per standard practice for up to 14 weeks.
753736|NCT01589497|B5|Baseline|Total|Total of all reporting groups
753737|NCT01589497|B4|Baseline|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753738|NCT01589497|B3|Baseline|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753739|NCT01589497|B2|Baseline|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753740|NCT01589497|B1|Baseline|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753741|NCT01589497|P4|Participant Flow|RZE-RZE|"Participants were administered only RZE from Day 1 through Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
753742|NCT01589497|P3|Participant Flow|RHZE-RMZE|"Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.~Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.~Moxifloxacin: one 400 mg tablet orally once a day."
753801|NCT01589237|B1|Baseline|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
754208|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
753819|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753883|NCT01588548|E5|Reported Event|AZD1208 700mg|Once daily continuous dosing schedule.
753884|NCT01588548|E4|Reported Event|AZD1208 540mg|Once daily continuous dosing schedule.
753743|NCT01589497|P2|Participant Flow|RHZE-RZE|"Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.~Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once"
753744|NCT01589497|P1|Participant Flow|RHZE-RHZE|"Participants were administered RHZE from Day 1 to Day 14. Rifampicin: Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily; with body weight >50kg were administered one 600 mg tablet orally once daily.~Isoniazid: Participants were administered three 100 mg tablets or one 300 mg tablet once daily.~Pyrazinamide: Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.~Ethambutol: Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily; with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily; with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily."
753745|NCT01589497|O1|Outcome|Overall|Qualified samples from overall participants
753746|NCT01589497|O2|Outcome|Decontaminated Processing Method|The decontaminated sputum processing method
753747|NCT01589497|O1|Outcome|Standard Processing Method|The standard sputum processing method
753748|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753749|NCT01589497|O3|Outcome|RHZE-RMZE|Participants will be administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753750|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753751|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753752|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753753|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753754|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753755|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753756|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753757|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753758|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753759|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753760|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753761|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753762|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753763|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753764|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753765|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753766|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753767|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753768|NCT01589497|O4|Outcome|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753769|NCT01589497|O3|Outcome|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753770|NCT01589497|O2|Outcome|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753771|NCT01589497|O1|Outcome|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753772|NCT01589497|E4|Reported Event|RZE-RZE|Participants were administered only RZE from Day 1 through Day 14.
753773|NCT01589497|E3|Reported Event|RHZE-RMZE|Participants were administered RHZE Day 1 to Day 2 and RMZE from Day 3 to Day 14.
753774|NCT01589497|E2|Reported Event|RHZE-RZE|Participants were administered RHZE from Day 1 to Day 2, then RZE from Day 3 to Day 14.
753775|NCT01589497|E1|Reported Event|RHZE-RHZE|Participants were administered RHZE from Day 1 to Day 14.
753776|NCT01589484|B1|Baseline|Shockwave Lithotripsy (SWL)|One hundred patients fulfilled the inclusion and exclusion criteria and were enrolled in this study. Mean age and BMI were 47.1 years and 28.0 Kg/m2, respectively. Half of patients had their stone localized in the right kidney. Mean stone size was 9.1mm and mean stone density was 795 HU.
753777|NCT01589484|P1|Participant Flow|Shockwave Lithotripsy (SWL)|All patients were submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients were submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
753778|NCT01589484|O1|Outcome|SWL Complications|Shock wave lithotripsy complications
753779|NCT01589484|O1|Outcome|Primary Endoint|Shock wave lithotripsy outcome
753780|NCT01589484|E1|Reported Event|Shockwave Lithotripsy (SWL)|All patients will be submitted to a noncontrast computed tomography before to shockwave lithotripsy (SWL). Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
753873|NCT01588548|P3|Participant Flow|AZD1208 360mg|Once daily continuous dosing schedule.
753874|NCT01588548|P2|Participant Flow|AZD1208 240mg|Once daily continuous dosing schedule.
753875|NCT01588548|P1|Participant Flow|AZD1208 120mg|Once daily continuous dosing schedule.
753781|NCT01589445|B1|Baseline|Single Group Study With Two Interventions|"This was double blind, single group and within subjects designed study with two interventions.We screened 130 patients, selected 77 subjects who received drug Code 001, then gone through one month wash out period, then received Code 002.For PPARγ genotyping blood samples were collected from patients. There were found two groups-Pro12Pro and Pro12Ala. Baseline evaluation included detailed medical history,socioeconomic status, physical examination, and laboratory investigations for biomedical variables,psychosocial factors according to Patient Health Questionnaire (PHQ-9) and WHO-5 questionnaires.We decoded blinded drug after analyzing the results and knew that pioglitazone (30 mg once daily) was coded as 001 and metformin (850 mg once daily) as code 002.~For statistical analysis we compare Pio vs Met, Pro12Pro vs Pro12Ala, met responder vs non responder."
753782|NCT01589445|P1|Participant Flow|Single Group Study With Two Drugs- Pioglitazone and Metformin|"Group 001-Pioglitazone 30 mg tablet once daily Group 002-Metformin 850 mg tablet once daily~The single group study with a wash out period of one month with metformin 850 mg tablet once daily.~77 patients started with pioglitazone(7 drop out)and after one month wash out period 70 patients started with metformin (9 drop out).~48 patients for the 1st 3 months of pioglitazone and 32 patients for the 2nd 3 months of metformin responded to the drugs respectively according to the response rate[The treatment target was set to reduce at least ≥10% FBG or ≥1% HbA1c in the patients considering as the responder group]."
753783|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
753784|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
753785|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
753786|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
753787|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
753788|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
753789|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
753790|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
753791|NCT01589445|O2|Outcome|Metformin ( 002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
753792|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30mg once daily for 3 months.
753793|NCT01589445|O2|Outcome|Metformin (002 Group)|Dose: Metformin tablet 850 mg once daily for 3 months
753794|NCT01589445|O1|Outcome|Pioglitazone (001 Group)|Dose: Pioglitazone tablet 30 mg once daily for 3 months
753795|NCT01589445|E2|Reported Event|Metformin (002 Group)|"After wash out period 70 patients started with metformin (850mg/day) for further 3 months. Adverse events were assessed non-systematically on patients' complain and also systematically in case of hypertension, weight gain, common depression (PHQ-9 method) and creatinine increase.~On basis of systemic data review and patient complain one patient was found with hypertension and another one was with increased creatinine level at the end of the metformin treatment and these events were assumed as serious adverse events as they were at health risk and withdrawn from the trial for intervention by hospital physician though they didn't need for hospitalization.~One patient complained for mild diarrhea in the first month of the metformin treatment, the patient needed necessary treatment according to doctor's advice for one day, Five patients complained for abdominal discomfort in the 1st month and antacid was provided. Six patients were assumed suffering from common depression."
753796|NCT01589445|E1|Reported Event|Pioglitazone (001 Group)|"77 patients received the drug pioglitazone (30mg/day) for 3 months. Adverse events were assessed non-systematically on patients' complain generally and also systematically in case of hypertension, weight gain, common depression [Patient Health Questionnaire (PHQ-9) method] and creatinine increase.~No serious adverse event was found during pioglitazone trial.~In case of other adverse event, one patient complained for peripheral edema which disappeared (without medicine) within 2 days at the 2nd month of the treatment, Four patients gained weight within 10% of their initial weight after 3 months of the treatment and two patients complained for abdominal discomfort in the 1st month and normal treatment with antacid was provided to them."
753797|NCT01589237|B5|Baseline|Total|Total of all reporting groups
753798|NCT01589237|B4|Baseline|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
753799|NCT01589237|B3|Baseline|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
753800|NCT01589237|B2|Baseline|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
753818|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753876|NCT01588548|O6|Outcome|AZD1208 800mg|Once daily continuous dosing schedule.
753802|NCT01589237|P4|Participant Flow|Pradigastat (LCQ908) Regimen- From Study A2212|"Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
753803|NCT01589237|P3|Participant Flow|40 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
753804|NCT01589237|P2|Participant Flow|20 mg Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
753805|NCT01589237|P1|Participant Flow|Placebo of Pradigastat (LCQ908) Regimen|"Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.~Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile."
753806|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753807|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753808|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753809|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753810|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753811|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753812|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753813|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753814|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753815|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753816|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753817|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753867|NCT01588548|B3|Baseline|AZD1208 360mg|Once daily continuous dosing schedule.
753868|NCT01588548|B2|Baseline|AZD1208 240mg|Once daily continuous dosing schedule.
753820|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753821|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753822|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753823|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753824|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753825|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753826|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753827|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753828|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753829|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753830|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753831|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753832|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753833|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753834|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753835|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753836|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753837|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753869|NCT01588548|B1|Baseline|AZD1208 120mg|Once daily continuous dosing schedule.
753870|NCT01588548|P6|Participant Flow|AZD1208 800mg|Once daily continuous dosing schedule.
754209|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
753838|NCT01589237|O4|Outcome|Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753839|NCT01589237|O3|Outcome|40 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753840|NCT01589237|O2|Outcome|20 mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753841|NCT01589237|O1|Outcome|Placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753842|NCT01589237|E8|Reported Event|Part B-40 mg Pradigastat (LCQ908)|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
753843|NCT01589237|E7|Reported Event|Part B- Pradigastat (LCQ908) Regimen- From Study A2212|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
753844|NCT01589237|E6|Reported Event|Part B-20mg Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
753845|NCT01589237|E5|Reported Event|Part B-placebo of Pradigastat (LCQ908) Regimen|Part B: Patients who consented to take part in the Part B continued their treatment at the same dose as they took when they completed Part A. LCQ908 treatment could be titrated (within the dose range 10 mg to 40 mg) at the investigators discretion and based on individual patients’ tolerance and safety profile.
753846|NCT01589237|E4|Reported Event|Part A: Pradigastat (LCQ908) Regimen- From Study A2212|Part A: Patients who were randomized to LCQ908 in study CLCQ908A2212/NCT01146522. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753847|NCT01589237|E3|Reported Event|Part A-40mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 40 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753848|NCT01589237|E2|Reported Event|Part A-20mg Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to LCQ908 20 mg in study CLCQ908B2302/NCT01514461. In current study, patients initiated at LCQ908 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753849|NCT01589237|E1|Reported Event|Part A-placebo of Pradigastat (LCQ908) Regimen|Part A: Patients who were randomized to placebo in study CLCQ908B2302/NCT01514461. In current study, patients initiated at 10 mg/day. After at least 8 weeks of treatment with a dose, optional up-titration to the next possible dose was allowed. One down titration allowed from the highest dose attained.
753850|NCT01588951|B4|Baseline|Total|Total of all reporting groups
753851|NCT01588951|B3|Baseline|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
753852|NCT01588951|B2|Baseline|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753853|NCT01588951|B1|Baseline|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753854|NCT01588951|P3|Participant Flow|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
753855|NCT01588951|P2|Participant Flow|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753856|NCT01588951|P1|Participant Flow|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753857|NCT01588951|O3|Outcome|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
753858|NCT01588951|O2|Outcome|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753859|NCT01588951|O1|Outcome|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753860|NCT01588951|E3|Reported Event|Arm 3|"LSC present, randomized to allogeneic transplant~Allogeneic transplant: Allogeneic stem cell transplant per institutional standards."
753861|NCT01588951|E2|Reported Event|Arm 2|"LSC present, randomized to cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753862|NCT01588951|E1|Reported Event|Arm 1|"Without LSC, standard cytarabine consolidation~Cytarabine consolidation: Cytarabine-based consolidation per institutional standards."
753863|NCT01588548|B7|Baseline|Total|Total of all reporting groups
753864|NCT01588548|B6|Baseline|AZD1208 800mg|Once daily continuous dosing schedule.
753865|NCT01588548|B5|Baseline|AZD1208 700mg|Once daily continuous dosing schedule.
753866|NCT01588548|B4|Baseline|AZD1208 540mg|Once daily continuous dosing schedule.
753877|NCT01588548|O5|Outcome|AZD1208 700mg|Once daily continuous dosing schedule.
753878|NCT01588548|O4|Outcome|AZD1208 540mg|Once daily continuous dosing schedule.
753879|NCT01588548|O3|Outcome|AZD1208 360mg|Once daily continuous dosing schedule.
753880|NCT01588548|O2|Outcome|AZD1208 240mg|Once daily continuous dosing schedule.
753885|NCT01588548|E3|Reported Event|AZD1208 360mg|Once daily continuous dosing schedule.
753886|NCT01588548|E2|Reported Event|AZD1208 240mg|Once daily continuous dosing schedule.
753887|NCT01588548|E1|Reported Event|AZD1208 120mg|Once daily continuous dosing schedule.
753888|NCT01588496|B4|Baseline|Total|Total of all reporting groups
753889|NCT01588496|B3|Baseline|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753890|NCT01588496|B2|Baseline|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753891|NCT01588496|B1|Baseline|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753892|NCT01588496|P3|Participant Flow|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753893|NCT01588496|P2|Participant Flow|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753894|NCT01588496|P1|Participant Flow|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753895|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753896|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753897|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753898|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753899|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753900|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753901|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753902|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753903|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753904|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753905|NCT01588496|O2|Outcome|Part B: Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753906|NCT01588496|O1|Outcome|Part B: Placebo|Participants received double-blind placebo subcutaneously once a month for 12 weeks.
753907|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753908|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753909|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753910|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753911|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753912|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753913|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753914|NCT01588496|O1|Outcome|Part A: Evolocumab|Participants received open-label evolocumab 420 mg subcutaneously (SC) once a month (QM) for 12 weeks.
753915|NCT01588496|E3|Reported Event|Part B: DB Evolocumab|Participants received double-blind evolocumab 420 mg subcutaneously once a month for 12 weeks.
753916|NCT01588496|E2|Reported Event|Part B: DB Placebo|Participants received double-blind (DB) placebo subcutaneously once a month for 12 weeks.
753917|NCT01588496|E1|Reported Event|Part A: OL Evolocumab|Participants received open-label (OL) evolocumab 420 mg subcutaneously once a month for 12 weeks.
753918|NCT01588444|B3|Baseline|Total|Total of all reporting groups
753919|NCT01588444|B2|Baseline|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
753920|NCT01588444|B1|Baseline|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
753921|NCT01588444|P2|Participant Flow|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
753922|NCT01588444|P1|Participant Flow|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
753923|NCT01588444|O2|Outcome|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
753924|NCT01588444|O1|Outcome|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
753925|NCT01588444|E2|Reported Event|Cortical FDBA (LifeNet)|"CORTICAL FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)~cortical FDBA: cortical mineralized freeze-dried bone allograft"
754210|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
753926|NCT01588444|E1|Reported Event|Cancellous FDBA (LifeNet)|"grafting with cancellous mineralized freeze-dried bone allograft (LifeNet Health)~Cancellous FDBA: CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)"
753927|NCT01588418|B1|Baseline|PET With Exenatide vs Placebo Injection|"All subjects will receive the same intervention with Exenatide and placebo. Exenatide or placebo will be administered in random order, (i.e. first or second before OGTT-PET study).~In the first study IGT male subjects will be randomized to exenatide or placebo injection before OGTT-PET study. In the second study the same subjects will receive placebo or exenatide respectively before OGTT-PET study. The results obtained after Exenatide injection will be compared with the ones obtained after injection of placebo in the same subject."
753928|NCT01588418|P2|Participant Flow|OGTT-PET: Placebo First, Then Exenatide|In the first study subjects received placebo injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received exenatide injection (5ug) before OGTT-PET
753929|NCT01588418|P1|Participant Flow|OGTT-PET: Exenatide First Then Placebo|In the first study subjects received exenatide 5ug injected before OGTT-PET. In the second study (3 to 12 wk after first study), subjects received placebo injection before OGTT-PET
753930|NCT01588418|O1|Outcome|Effect of Exenatide or Placebo on CMRglu|Brain glucose metabolism (CMRglu) during OGTT measured by PET w/ or w/out Exenatide injection
753931|NCT01588418|E1|Reported Event|PET With Exenatide or Placebo Injection|This is a crossover study where all subjects received the same intervention with Exenatide and placebo, acutely in random order, (i.e. first or second before OGTT-PET study).
753932|NCT01588405|B1|Baseline|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753933|NCT01588405|P1|Participant Flow|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753934|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753935|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753936|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753937|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753938|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753939|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753940|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
753941|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
753942|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
753943|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
753944|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
753945|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
753946|NCT01588405|O3|Outcome|UT-15C SR (TID)|Subjects who were on TID dosing of UT-15C SR at week 24
753947|NCT01588405|O2|Outcome|UT-15C SR (BID)|Subjects who were on BID dosing of UT-15C SR at week 24
753948|NCT01588405|O1|Outcome|IV Remodulin / SQ Remodulin|Baseline while on infused Remodulin
753949|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753950|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
754211|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
753951|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753976|NCT01588353|E1|Reported Event|AK160 0.58 mg Step 1-3|Collagenase Clostridium Histolyticum: AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
753977|NCT01588158|B3|Baseline|Total|Total of all reporting groups
753978|NCT01588158|B2|Baseline|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753952|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753953|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753954|NCT01588405|O1|Outcome|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753955|NCT01588405|E1|Reported Event|UT-15C SR|UT-15C SR: Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
753956|NCT01588353|B4|Baseline|Total|Total of all reporting groups
753957|NCT01588353|B3|Baseline|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
753958|NCT01588353|B2|Baseline|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
753959|NCT01588353|B1|Baseline|AK160 0.58 mg Step 1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
753960|NCT01588353|P3|Participant Flow|AK160 0.58 mg Step3|"The participants in step 3 were added until the number of injected joints by joint type became up to 50 or more in steps1 through 3.~This arm was mainly used to determine the safety of the drug with participants enrolled in steps 1 and 2.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
753961|NCT01588353|P2|Participant Flow|AK160 0.58 mg Step 2|"This arm consisting of participants enrolled in step 2 was used to determine the efficacy of the drug with participants enrolled in step 1 and to determine the safety with participants enrolled in steps 1 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
753962|NCT01588353|P1|Participant Flow|AK160 0.58 mg Step1|"This arm consisting of participants enrolled in step 1 was used to confirm the efficacy and satety of the drug 30 days after the first dose before starting step 2.~And also this arm was used to determine the efficacy of the drug with participants enrolled in step 2 and to determine the safety with participants enrolled in steps 2 and 3.~Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal(PIP) joints. Collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints."
753963|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
753964|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
753965|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
753966|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
753967|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
753968|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
753969|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
753970|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
753971|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
753972|NCT01588353|O3|Outcome|Total|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) or proximal interphalangeal (PIP) joints
753973|NCT01588353|O2|Outcome|Primary PIP Joints|collagenase clostridium histolyticum 0.58mg injected into proximal interphalangeal (PIP) joints
753974|NCT01588353|O1|Outcome|Primary MP Joints|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) joints
753975|NCT01588353|O1|Outcome|AK160 0.58 mg Step 1-2|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
754222|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
753979|NCT01588158|B1|Baseline|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753980|NCT01588158|P2|Participant Flow|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753981|NCT01588158|P1|Participant Flow|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753982|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753983|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753984|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753985|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753986|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753987|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753988|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753989|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753990|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753991|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753992|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753993|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753994|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753995|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753996|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753997|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
753998|NCT01588158|O2|Outcome|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
753999|NCT01588158|O1|Outcome|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
754000|NCT01588158|E2|Reported Event|Acetaminophen 325 mg|"Half of the patients will be randomized to Acetaminophen~Vicodin: Vicodin 5/325 mg"
754001|NCT01588158|E1|Reported Event|Vicodin 5/325 mg|"Half of the patients will be randomized to Vicodin~Acetaminophen: 325 mg"
754002|NCT01588106|B3|Baseline|Total|Total of all reporting groups
754003|NCT01588106|B2|Baseline|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754004|NCT01588106|B1|Baseline|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754005|NCT01588106|P2|Participant Flow|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754006|NCT01588106|P1|Participant Flow|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754007|NCT01588106|O2|Outcome|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754008|NCT01588106|O1|Outcome|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754009|NCT01588106|E2|Reported Event|Control Group- Standard CONTOUR|Subjects used the standard CONTOUR device. Subjects’ blood glucose values were communicated to their health care professionals via handwritten glucose log books. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754010|NCT01588106|E1|Reported Event|Test Group- CONTOUR Next USB|Subjects applied the CONTOUR NextT USB device. This group was not required to keep a paper log book. Subjects’ blood glucose values were communicated to their health care professionals by using the data management software. Patients were trained in using the device and return every 3 months until month 9 after baseline.
754011|NCT01587989|B3|Baseline|Total|Total of all reporting groups
754049|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
754212|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
754213|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
754012|NCT01587989|B2|Baseline|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754013|NCT01587989|B1|Baseline|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754014|NCT01587989|P3|Participant Flow|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754015|NCT01587989|P2|Participant Flow|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754016|NCT01587989|P1|Participant Flow|All Participants|Participants received TCZ 8 milligrams per kilogram (mg/kg), intravenously (IV), every 4 weeks, from Weeks 1-12. Participants also received MTX 15 milligrams per week (mg/week) to 25 mg/week at a stable dose, orally (PO) as tablets, once per week, from Weeks 1-12. Participants also received folic acid, greater than or equal to (≥) 5 mg/week, PO, from Weeks 1-12. Participants also received non-sterioidal anti-inflammatory drugs (NSAIDs) and oral corticosteroids (less than or equal to [≤] 10 milligrams per day [mg/day] prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-12. At Week 12 participants who had achieved a good or moderate European League Against Rheumatism (EULAR) response were randomized to receive TCZ plus (+) continued MTX treatment or TCZ + placebo. Participants without a good or moderate EULAR response were excluded from the study and treated according to the standard of care of the treatment site.
754017|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754018|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754019|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754020|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754050|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
754051|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
754214|NCT01587079|O6|Outcome|GFF MDI BID 1.2/9.6 μg|BID 1.2/9.6 μg
754021|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754022|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754023|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754024|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754025|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754026|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754027|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754028|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754029|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754030|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754031|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754032|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754033|NCT01587989|O2|Outcome|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754034|NCT01587989|O1|Outcome|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754035|NCT01587989|E2|Reported Event|Group B: TCZ + Placebo|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-12. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive placebo, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Day 1 through Week 24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754036|NCT01587989|E1|Reported Event|Group A: TCZ + MTX|During a 12-week run-in period, all participants received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 1-12. Participants also received MTX 15-25 mg/week at a stable dose, PO as tablets, once per week, from Weeks 1-24. At Week 12, participants who had achieved a good or moderate EULAR response were randomized to receive MTX at the same dose they received from Weeks 1-12, PO as tablets, once per week, from Weeks 12-24. Participants also received TCZ 8 mg/kg, IV, every 4 weeks, from Weeks 12-24. Participants also received NSAIDs and oral corticosteroids (≤ 10 mg/day prednisone or equivalent) according to the standard of care of the treatment site from Weeks 1-24. Participants also received folic acid, ≥ 5 mg/week, PO, from Weeks 1-24.
754037|NCT01587963|B3|Baseline|Total|Total of all reporting groups
754038|NCT01587963|B2|Baseline|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
754039|NCT01587963|B1|Baseline|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
754040|NCT01587963|P2|Participant Flow|Placebo|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
754041|NCT01587963|P1|Participant Flow|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
754042|NCT01587963|O2|Outcome|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
754043|NCT01587963|O1|Outcome|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
754044|NCT01587963|E2|Reported Event|Ringers Lactate or Normal Saline|"Ringers Lactate or Normal Saline~Ringers Lactate or Normal Saline: Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour."
754045|NCT01587963|E1|Reported Event|Ascorbic Acid|"Ascorbic Acid~Ascorbic Acid: 66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams"
754046|NCT01587950|B1|Baseline|Overall|All randomized participants received all study treatments during this cross over study design.
754047|NCT01587950|P1|Participant Flow|Overall|There were six study treatment regimens- 5% Potassium nitrate (KNO3) 250μl applied to an individual tooth once for 2, 5 or 10 min; 2.5% KNO3 (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Three reference treatment regimens were sterile water (250μl) applied to an individual tooth once for 2, 5 or 10 mins. Each participant received 9 treatment regimens over three treatment visits. Three individual teeth were treated at each treatment visit. Each treatment visit was one day in length. A washout of 4 days was given after each treatment visit. Study duration for each participant during this efficacy analysis phase was approximately 5 weeks
754048|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
754175|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
754052|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
754053|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
754054|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
754055|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
754056|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
754057|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
754058|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
754059|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
754060|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
754061|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
754062|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
754063|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
754064|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth sensitive tooth once for 2 minutes during each treatment period.
754065|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
754066|NCT01587950|O9|Outcome|Sterile Water (10 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 10 minutes during each treatment period.
754067|NCT01587950|O8|Outcome|5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
754068|NCT01587950|O7|Outcome|2.5% KNO3 Solution (10 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 10 minutes during each treatment period.
754069|NCT01587950|O6|Outcome|Sterile Water (5 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 5 minutes during each treatment period.
754070|NCT01587950|O5|Outcome|5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
754071|NCT01587950|O4|Outcome|2.5% KNO3 Solution (5 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 5 minutes during each treatment period.
754072|NCT01587950|O3|Outcome|Sterile Water (2 Minutes)|Participants were administered with a maximum of 250μl of sterile water to a single sensitive tooth once for 2 minutes during each treatment period.
754073|NCT01587950|O2|Outcome|5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
754074|NCT01587950|O1|Outcome|2.5% KNO3 Solution (2 Minutes)|Participants were administered with a maximum of 250μl of 2.5% KNO3 solution to a single sensitive tooth once for 2 minutes during each treatment period.
754075|NCT01587950|E1|Reported Event|Overall|All participants received all study treatments during this cross over study design.
754076|NCT01587885|B1|Baseline|All Participants|All participants who were randomized and received study drug.
754077|NCT01587885|P2|Participant Flow|Omeprazole 20mg Then Omeprazole 20mg+Sodium Bicarbonate 1100mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
754078|NCT01587885|P1|Participant Flow|Omeprazole 20mg+Sodium Bicarbonate 1100mg Then Omeprazole 20mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
754079|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
754080|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
754081|NCT01587885|O1|Outcome|All Treated Participants|
754082|NCT01587885|O1|Outcome|All Treated Participants|
754083|NCT01587885|O1|Outcome|All Treated Participants|
754084|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
754085|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
754086|NCT01587885|O2|Outcome|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days.
754087|NCT01587885|O1|Outcome|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
754088|NCT01587885|E2|Reported Event|Omeprazole 20 mg|Participants will receive omeprazole 20 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days.
754089|NCT01587885|E1|Reported Event|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Participants will receive omeprazole 20 mg + sodium bicarbonate 1100 mg once a day for 4 days, and then after a washout period, omeprazole 20 mg once a day for 4 days.
754090|NCT01587651|B4|Baseline|Total|Total of all reporting groups
754091|NCT01587651|B3|Baseline|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
754092|NCT01587651|B2|Baseline|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
754093|NCT01587651|B1|Baseline|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
754094|NCT01587651|P3|Participant Flow|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
754095|NCT01587651|P2|Participant Flow|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
754096|NCT01587651|P1|Participant Flow|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
754097|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
754098|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
754099|NCT01587651|O2|Outcome|Ticagrelor|
754100|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
754101|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
754102|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
754103|NCT01587651|O2|Outcome|Ticagrelor|
754104|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
754105|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
754106|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
754107|NCT01587651|O2|Outcome|Ticagrelor|
754108|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
754109|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
754110|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
754111|NCT01587651|O2|Outcome|Ticagrelor|
754112|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
754113|NCT01587651|O4|Outcome|Prasugrel Maintenance Dose|prasugrel 10 mg QD for 7 days
754114|NCT01587651|O3|Outcome|Prasugrel Loading Dose|prasugrel 60 mg loading dose followed by 10 mg QD for 6 days
754115|NCT01587651|O2|Outcome|Ticagrelor|
754116|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
754117|NCT01587651|O2|Outcome|Ticagrelor|
754118|NCT01587651|O1|Outcome|Prasugrel Combined Groups|combined Prasugrel loading dose and Prasugrel maintenance dose
754119|NCT01587651|E3|Reported Event|Ticagrelor Maintenance Dose|"Ticagrelor 90 mg twice-daily (BID) MD~Ticagrelor Maintenance Dose : one 90mg film coated tablet"
754120|NCT01587651|E2|Reported Event|Prasugrel Maintenance Dose|"Prasugrel 10 mg QD MD~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet"
754121|NCT01587651|E1|Reported Event|Prasugrel Loading Dose|"Prasugrel 60mg Loading Dose (LD), followed by prasugrel 10mg once-daily (QD) Maintenance Dose (MD)~Prasugrel Maintenance Dose : 10mg maintenance dose, given as one 10mg film coated tablet~Prasugrel Loading Dose : 60mg given as six 10mg film coated tablets"
754122|NCT01587118|B1|Baseline|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
754123|NCT01587118|P1|Participant Flow|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
754124|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
754125|NCT01587118|O1|Outcome|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
754126|NCT01587118|E1|Reported Event|Antidepressant Plus Asenapine|"adjunctive asenapine~Adjunctive asenapine: participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks."
754127|NCT01587105|B3|Baseline|Total|Total of all reporting groups
754128|NCT01587105|B2|Baseline|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754129|NCT01587105|B1|Baseline|Control|Usual Care Group
754176|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
754177|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
754178|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
754130|NCT01587105|P2|Participant Flow|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754131|NCT01587105|P1|Participant Flow|Control|Usual Care Group
754132|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754133|NCT01587105|O1|Outcome|Control|Usual Care Group
754134|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754135|NCT01587105|O1|Outcome|Control|Usual Care Group
754136|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754137|NCT01587105|O1|Outcome|Control|Usual Care Group
754138|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754139|NCT01587105|O1|Outcome|Control|Usual Care Group
754140|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754141|NCT01587105|O1|Outcome|Control|Usual Care Group
754142|NCT01587105|O2|Outcome|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754143|NCT01587105|O1|Outcome|Control|Usual Care Group
754144|NCT01587105|E2|Reported Event|Comprehensive Care Management Service|"Care Coordination through the Comprehensive Care Management Service at Seattle Children's Hospital~Comprehensive Case Management Service: When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse."
754145|NCT01587105|E1|Reported Event|Control|Usual Care Group
754146|NCT01587079|B1|Baseline|All Subjects Screened|
754147|NCT01587079|P1|Participant Flow|All Subjects|
754148|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
754149|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
754150|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
754151|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
754152|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg BID|4.6/9.6 μg BID
754153|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
754154|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
754155|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
754156|NCT01587079|O8|Outcome|Spiriva18 μg QD|18 μg QD
754157|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
754158|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
754159|NCT01587079|O5|Outcome|GFF MDI 2.4/9.6 μg BID|2.4/9.6 μg BID
754160|NCT01587079|O4|Outcome|GFF MDI 4.6/9.6 μg BID|4.6/9.6 μg BID
754161|NCT01587079|O3|Outcome|GFF/MDI 9/9.6 μg BID|9/9.6 μg BID
754162|NCT01587079|O2|Outcome|GFF MDI 18/9.6 μg BID|18/9.6 μg BID
754163|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
754164|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
754165|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
754166|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
754167|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
754168|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
754169|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
754170|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
754171|NCT01587079|O1|Outcome|GP MDI 18 μg BID|18 μg BID
754172|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
754173|NCT01587079|O7|Outcome|FF MDI 9.6 μg BID|9.6 μg BID
754174|NCT01587079|O6|Outcome|GFF MDI 1.2/9.6 μg BID|1.2/9.6 μg BID
754215|NCT01587079|O5|Outcome|GFF MDI BID 2.4/9.6 μg|BID 2.4/9.6 μg
754216|NCT01587079|O4|Outcome|GFF MDI BID 4.6/9.6 μg|4.6/9.6 μg
754217|NCT01587079|O3|Outcome|GFF/MDI BID 9/9.6 μg|BID 9/9.6 μg
754218|NCT01587079|O2|Outcome|GFF MDI BID 18/9.6 μg|BID 18/9.6 μg
754219|NCT01587079|O1|Outcome|GP MDI BID 18 μg|BID 18 μg
754220|NCT01587079|O8|Outcome|Spiriva 18 μg QD|18 μg QD
754221|NCT01587079|O7|Outcome|FF MDI BID 9.6 μg|BID 9.6 μg
754262|NCT01587079|E6|Reported Event|GFF MDI 1.2/9.6 μg (PT003)|1.2/9.6 μg
754263|NCT01587079|E5|Reported Event|GFF MDI 2.4/9.6 μg (PT003)|2.4/9.6 μg
754264|NCT01587079|E4|Reported Event|GFF MDI 4.6/9.6 μg (PT003)|4.6/9.6 μg
754265|NCT01587079|E3|Reported Event|GFF MDI 9/9.6 μg (PT003)|9/9.6 μg
754266|NCT01587079|E2|Reported Event|GFF MDI 18/9.6 μg (PT003)|18/9.6 μg
754267|NCT01587079|E1|Reported Event|GP MDI 18 μg (PT001)|18 μg
754268|NCT01587027|B3|Baseline|Total|Total of all reporting groups
754269|NCT01587027|B2|Baseline|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
754270|NCT01587027|B1|Baseline|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
754271|NCT01587027|P2|Participant Flow|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
754272|NCT01587027|P1|Participant Flow|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
754273|NCT01587027|O2|Outcome|Sequence B|"Treatment 2, Treatment 1, Treatment 3~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally~Treatment 2 : Methazolamide dosage form-tablet dosage-250mg"
754274|NCT01587027|O1|Outcome|Sequence A|"Treatment 1, Treatment 2, Treatment 3~Treatment 1 : Aminophylline dosage form-tablet dosage-500mg~Treatment 3 : Aminophylline 500mg orally and Methazolamide 250mg orally"
754275|NCT01587027|E2|Reported Event|Arm B|Methazolamide (1 Day) Washout (1 Day) Aminophylline (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
754276|NCT01587027|E1|Reported Event|Arm A|Aminophylline (1 Day) Washout (1 Day) Methazolamide (1 Day) Washout (1 Day) Both Aminophylline & Methazolamide (1 Day) Discharge (1 Day)
754277|NCT01587014|B1|Baseline|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
754278|NCT01587014|P1|Participant Flow|Prima-Temp Monitoring Patch|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
754279|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
754280|NCT01587014|O1|Outcome|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
754281|NCT01587014|E1|Reported Event|Device Arm|ICU patients receive the Prima-Temp Temperature Monitoring Patch.
754282|NCT01587001|B3|Baseline|Total|Total of all reporting groups
754283|NCT01587001|B2|Baseline|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
754284|NCT01587001|B1|Baseline|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
754285|NCT01587001|P2|Participant Flow|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
754286|NCT01587001|P1|Participant Flow|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
754287|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
754288|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|"oral NAC 900mg three times daily for 8 weeks~N-acetyl-cysteine: 900mg three times daily for 8 weeks"
754289|NCT01587001|O2|Outcome|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
754290|NCT01587001|O1|Outcome|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
754291|NCT01587001|E2|Reported Event|Matching Placebo|Placebo: Matching placebo three times daily for 8 weeks.
754292|NCT01587001|E1|Reported Event|Oral N-acetyl-cysteine|N-acetyl-cysteine: 900mg three times daily for 8 weeks
754293|NCT01586975|B4|Baseline|Total|Total of all reporting groups
754294|NCT01586975|B3|Baseline|Aspiring >300 mg|Aspirin >300 mg QD
754295|NCT01586975|B2|Baseline|Aspirin 81 mg|Aspirin 81 mg QD
754296|NCT01586975|B1|Baseline|Clopidogrel 75 mg|Clopidogrel 75 mg QD
754297|NCT01586975|P3|Participant Flow|Aspirin > 300 mg|Aspiring > 300 mg QD
754298|NCT01586975|P2|Participant Flow|Aspirin 81 mg|Aspirin 81 mg QD
754299|NCT01586975|P1|Participant Flow|Clopidogrel 75 mg|Clopidogrel 75 mg QD
754300|NCT01586975|O3|Outcome|Aspirin > 300 mg|open-label Aspirin
754301|NCT01586975|O2|Outcome|Aspirin 81 mg|open label Aspirin
754302|NCT01586975|O1|Outcome|Clopidogrel 75 mg|Clopidogrel 75 mg QD
754303|NCT01586975|E3|Reported Event|Aspirin >300 mg|Aspirin >300 mg QD
754304|NCT01586975|E2|Reported Event|Aspirin 81 mg|Aspirin 81 mg QD
754305|NCT01586975|E1|Reported Event|Clopidogrel 75 mg|Clopidogrel 75 mg QD
754306|NCT01586962|B1|Baseline|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
754307|NCT01586962|P1|Participant Flow|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
754308|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
754309|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
754310|NCT01586962|O1|Outcome|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
754311|NCT01586962|E1|Reported Event|Upper Respiratory Infections|IFF flavor 316 282, Paracetamol, Pseudoephedrine : Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
754312|NCT01586897|B3|Baseline|Total|Total of all reporting groups
754313|NCT01586897|B2|Baseline|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
754314|NCT01586897|B1|Baseline|Use of Medication Metronome|"Medication Metronome: PCPs allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~While PCPs were randomized, analyses were at the patient level. Characteristics presented represent eligible patients of randomized PCPs."
754315|NCT01586897|P2|Participant Flow|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care~26 Primary Care Physicians randomized to Usual Care, with 1606 patients analyzed."
754316|NCT01586897|P1|Participant Flow|Use of Medication Metronome|"Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid.~26 Primary Care Physicians were randomized to Use of Medication Metronome with 2049 patients analyzed."
754317|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
754318|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
754319|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
754320|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
754321|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
754322|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
758512|NCT01568073|P5|Participant Flow|OPC 50mg|OPC, Opicapone 50mg
754323|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
754324|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
754325|NCT01586897|O2|Outcome|Usual Care|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
754326|NCT01586897|O1|Outcome|Use of Medication Metronome|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipid
754327|NCT01586897|E4|Reported Event|Usual Care - Patients|"Patients of PCPs allocated to Usual Care were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
754328|NCT01586897|E3|Reported Event|Use of Medication Metronome - Patients|"Patients of PCPs allocated to the Use of Medication Metronome were eligible for our outcomes if prescribed a new study medication or if they experienced a dose change of a study medication."
754329|NCT01586897|E2|Reported Event|Usual Care - PCPs|"PCPs allocated to the control arm will continue with usual care practices for laboratory monitoring.~Usual Care"
754330|NCT01586897|E1|Reported Event|Use of Medication Metronome - PCPs|Medication Metronome: Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia.
754331|NCT01586806|B4|Baseline|Total|Total of all reporting groups
754332|NCT01586806|B3|Baseline|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754333|NCT01586806|B2|Baseline|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754334|NCT01586806|B1|Baseline|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754335|NCT01586806|P3|Participant Flow|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754364|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754336|NCT01586806|P2|Participant Flow|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754337|NCT01586806|P1|Participant Flow|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754338|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754339|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754340|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754341|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754342|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754343|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754344|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754345|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754346|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754347|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754832|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
754348|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754349|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754350|NCT01586806|O3|Outcome|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754351|NCT01586806|O2|Outcome|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754352|NCT01586806|O1|Outcome|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754353|NCT01586806|E3|Reported Event|Dexamethasone 4 mg|Bupivacaine with 4 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
754354|NCT01586806|E2|Reported Event|Dexamethasone 1 mg|Bupivacaine with 1 mg of Dexamethasone: This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
754355|NCT01586806|E1|Reported Event|Control|Bupivacaine Only: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
754356|NCT01586364|B1|Baseline|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754357|NCT01586364|P1|Participant Flow|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754358|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754359|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754360|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754361|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754362|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754363|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
763129|NCT01545193|B3|Baseline|Total|Total of all reporting groups
754365|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754366|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754367|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754368|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754369|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754370|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754371|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754372|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754373|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754374|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754375|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754376|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754377|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754378|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754379|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754380|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754381|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754382|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754383|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754384|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754385|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754386|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754387|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754388|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754389|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754390|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754391|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754392|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754393|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754394|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754395|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754396|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754397|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754398|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754399|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754400|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754401|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754402|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754403|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754404|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754405|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754406|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754407|NCT01586364|O1|Outcome|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754408|NCT01586364|E1|Reported Event|Treatment Arm = 60 mg Ospemifene|Subjects took an oral dose of Ospemifene 60 mg tablet each morning with food for 52 weeks
754409|NCT01586338|B1|Baseline|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754410|NCT01586338|P1|Participant Flow|Synvisc|Three intra-articular (IA) injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754411|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754412|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754413|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754414|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754415|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754416|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754417|NCT01586338|O1|Outcome|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754418|NCT01586338|E1|Reported Event|Synvisc|Three IA injections of Synvisc (2.25 ml glass syringe containing 16 mg hylan G-F 20) at intervals of one week. The total duration of observation was 26 weeks.
754419|NCT01586312|B3|Baseline|Total|Total of all reporting groups
754420|NCT01586312|B2|Baseline|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
754421|NCT01586312|B1|Baseline|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
754422|NCT01586312|P2|Participant Flow|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
754423|NCT01586312|P1|Participant Flow|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
754424|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
754425|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
754426|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
754427|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
754428|NCT01586312|O2|Outcome|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
754429|NCT01586312|O1|Outcome|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
754430|NCT01586312|E2|Reported Event|Hyaluronic Acid (Durolane)|"Intraarticular injection of hyaluronic acid (60 mg)~Hyaluronic Acid: Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)"
754431|NCT01586312|E1|Reported Event|Allogenic Mesenchymal Stromal Cells|"Mesenchymal stem cells (MSC) prepared from bone marrow from healthy donor expanded ex vivo for 3-4 weeks. Intraarticular injection of 40 millions MSC.~Injection of Mesenchymal Stromal Cells: Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency"
754432|NCT01586195|B1|Baseline|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754433|NCT01586195|P1|Participant Flow|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 milligram (mg) orally twice daily (BID) until disease progression.
754434|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754435|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754602|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754436|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754437|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754438|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754439|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754440|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754441|NCT01586195|O1|Outcome|Vemurafenib|Participants with untreated or previously treated locally advanced, unresectable, Stage IIIc or metastatic melanoma who have an activating exon 15 BRAF mutation other than V600E received vemurafenib 960 mg orally BID until disease progression.
754442|NCT01586195|E1|Reported Event|Vemurafenib|Participants received vemurafenib 960 mg orally BID.
754443|NCT01586026|B1|Baseline|Combined Demographics|Demographics of 171 subjects that contributed to final data analysis
754444|NCT01586026|P3|Participant Flow|Group C|Maintenance flushes at days 57+
754445|NCT01586026|P2|Participant Flow|Group B|Maintenance flushes at days 29-56
754446|NCT01586026|P1|Participant Flow|Group A|Maintenance flushes at days 1-28
754447|NCT01586026|O3|Outcome|Group C|Maintenance flushes at days 57+
754448|NCT01586026|O2|Outcome|Group B|Maintenance flushes at days 29-56
754449|NCT01586026|O1|Outcome|Group A|Maintenance flushes at days 1-28
754450|NCT01586026|E3|Reported Event|Group C|Maintenance flushes at days 57+
754451|NCT01586026|E2|Reported Event|Group B|Maintenance flushes at days 29-56
754452|NCT01586026|E1|Reported Event|Group A|Maintenance flushes at days 1-28
754453|NCT01585987|B3|Baseline|Total|Total of all reporting groups
754454|NCT01585987|B2|Baseline|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment.
754455|NCT01585987|B1|Baseline|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
758513|NCT01568073|P4|Participant Flow|OPC 25mg|OPC, Opicapone 25mg
754456|NCT01585987|P2|Participant Flow|All Best Supportive Care (BSC)|All BSC includes both active and non-active BSC. Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. In non-active BSC, the fluoropyrimidine used during lead-in chemotherapy was not continued on study and no other chemotherapy or active treatment was used
754457|NCT01585987|P1|Participant Flow|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
754458|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
754459|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
754460|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
754461|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
754462|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
754463|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
754464|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
754465|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
754466|NCT01585987|O2|Outcome|All Best Supportive Care (BSC)|BSC may include the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization to this study), but no other active systemic anti-cancer treatment. All BSC = Active and non-active BSC.
754467|NCT01585987|O1|Outcome|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
754468|NCT01585987|E3|Reported Event|Non-Active BSC|Non-Active BSC involves supportive care with cessation of chemotherapy (no active drug)
754469|NCT01585987|E2|Reported Event|Active Best Supportive Care (BSC)|Active BSC includes the continuation of the fluoropyrimidine that was used during the lead-in chemotherapy (prior to randomization)
754470|NCT01585987|E1|Reported Event|Ipilimumab|Ipilimumab 10 milligram per kilogram body weight (mg/kg) solution intravenously (IV), over 90 minutes, once every 3 weeks for 4 doses, then 10 mg/kg every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose). The option of re-introduction, defined as an additional 4 doses of ipilimumab (a dose of 10 mg/kg every 3 weeks) was allowed only at discretion of the investigator if criteria for re-induction were met.
754471|NCT01585961|B1|Baseline|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754472|NCT01585961|P1|Participant Flow|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754473|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754574|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754474|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754475|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754476|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754477|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754478|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754479|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754480|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754603|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754481|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754482|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754483|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754484|NCT01585961|O1|Outcome|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754485|NCT01585961|E1|Reported Event|Catheter Ablation|"These patients have drug refractory, recurrent, symptomatic paroxysmal atrial fibrillation, are aged 18 years or older, and are able and willing to provide written informed consent to participate in the study.~Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter): Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly."
754486|NCT01585779|B3|Baseline|Total|Total of all reporting groups
754487|NCT01585779|B2|Baseline|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754488|NCT01585779|B1|Baseline|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754575|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754576|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754489|NCT01585779|P2|Participant Flow|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754490|NCT01585779|P1|Participant Flow|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754491|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754492|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754493|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754494|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754644|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754495|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754496|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754497|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754498|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754499|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754500|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754501|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754577|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754578|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754502|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754503|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754504|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754505|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754506|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754507|NCT01585779|O2|Outcome|Tri-Ad® Implant|The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring
764746|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
754508|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754509|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754510|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754511|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754512|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754513|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754514|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754579|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754580|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
758514|NCT01568073|P3|Participant Flow|OPC 5mg|OPC, Opicapone 5mg
754515|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754516|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754517|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754518|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754519|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754520|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754521|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754522|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754523|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754524|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754525|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754526|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754527|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754581|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754582|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
757843|NCT01570634|E1|Reported Event|Open Label CASAD|Treatment with CASAD for 14 days
754528|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754529|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754530|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754531|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754532|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754533|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754534|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754535|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754536|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754537|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754538|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754539|NCT01585779|O2|Outcome|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754540|NCT01585779|O1|Outcome|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754583|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754584|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
757844|NCT01570309|B3|Baseline|Total|Total of all reporting groups
754541|NCT01585779|E2|Reported Event|Tri-Ad® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Tri-Ad® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Tri-Ad® ring will occur in conjunction with another concomitant surgical repair procedure~Tri-Ad® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754542|NCT01585779|E1|Reported Event|Contour 3D® Implant|"The subject population includes patients indicated for a TV repair procedure concomitant to left-sided heart surgery, and for whom the surgeon considers the implantation of a Contour 3D® ring most appropriate to reconstruct the diseased valve. Patients with primary TV regurgitation will not be included in this study. Implantation with the Contour 3D® ring will occur in conjunction with another concomitant surgical repair procedure~Contour 3D® implant for tricuspid valve repair: Tricuspid annuloplasty ring"
754543|NCT01585597|B1|Baseline|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
754544|NCT01585597|P1|Participant Flow|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
754545|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
754546|NCT01585597|O1|Outcome|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
754547|NCT01585597|E1|Reported Event|Mild Hypothermia|"Reduction of body temperature to 34 degrees centigrade.~Zoll- Coolgaurd 3000: Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour."
754548|NCT01585584|B1|Baseline|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
754549|NCT01585584|P1|Participant Flow|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
754550|NCT01585584|O1|Outcome|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
754551|NCT01585584|E1|Reported Event|Victrelis Triple|All patients will receive a 4-week lead-in with peginterferon and ribavirin therapy, followed by 24 weeks of Pegetron 1.5mg/kg + weight-based ribavirin + boceprevir 800mg tid (Victrelis Triple)
754552|NCT01585558|B4|Baseline|Total|Total of all reporting groups
754553|NCT01585558|B3|Baseline|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754554|NCT01585558|B2|Baseline|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754555|NCT01585558|B1|Baseline|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754556|NCT01585558|P3|Participant Flow|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754557|NCT01585558|P2|Participant Flow|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754558|NCT01585558|P1|Participant Flow|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754559|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754560|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754561|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754562|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754563|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754564|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754565|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754566|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754567|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754568|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754569|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754570|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754571|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754572|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754573|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754585|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754586|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754587|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754588|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754589|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754590|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754591|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754592|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754593|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754594|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754595|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754596|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754597|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754598|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754599|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754600|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754601|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
764753|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
754604|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754605|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754606|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754607|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754608|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754609|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754610|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754611|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754612|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754613|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754614|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754615|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754616|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754617|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754618|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754619|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754620|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754621|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754622|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754623|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754624|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
757845|NCT01570309|B2|Baseline|Sugar Pill|Matching placebo
754625|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754626|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754627|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754628|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754629|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754630|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754631|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754632|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754633|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754634|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754635|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754636|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754637|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754638|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754639|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754640|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754641|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754642|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754643|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754645|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754646|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754647|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754648|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754649|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754650|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754651|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754652|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754653|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754654|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754655|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754656|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754657|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754658|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754659|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754660|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754661|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754662|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754663|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754664|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
758515|NCT01568073|P2|Participant Flow|Entacapone|Entacapone - 200 mg
754665|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754666|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754667|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754668|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754669|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754670|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754671|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754672|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754673|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754674|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754675|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754676|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754677|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754678|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754679|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754680|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754681|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754682|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754683|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754684|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754685|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754686|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754687|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754688|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754689|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754690|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754691|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754692|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754693|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754694|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754695|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754696|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754697|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754698|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754699|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754700|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754701|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754702|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754703|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754704|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
758516|NCT01568073|P1|Participant Flow|Placebo|Placebo 200 mg
754705|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754706|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754707|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754708|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754709|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754710|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754711|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754712|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754713|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754714|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754715|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754716|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754717|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754718|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754719|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754720|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754721|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754722|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754723|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754724|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754725|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754726|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754727|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754728|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754729|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754730|NCT01585558|O3|Outcome|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754731|NCT01585558|O2|Outcome|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754732|NCT01585558|O1|Outcome|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754733|NCT01585558|E3|Reported Event|Placebo|Subjects took a daily oral dose of one placebo tablet (identical in appearance to ospemifene tablets) each morning with food for 40 weeks
754734|NCT01585558|E2|Reported Event|Ospemifene 60 mg (Dose 2)|Subjects took a daily oral dose of one 60 mg ospemifene film-coated tablet each morning with food for 40 weeks
754735|NCT01585558|E1|Reported Event|Ospemifene 30 mg (Dose 1)|Subjects took a daily oral dose of one 30 mg ospemifene film-coated tablet each morning with food for 40 weeks
754736|NCT01585441|B3|Baseline|Total|Total of all reporting groups
754737|NCT01585441|B2|Baseline|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754738|NCT01585441|B1|Baseline|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754739|NCT01585441|P2|Participant Flow|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754740|NCT01585441|P1|Participant Flow|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754741|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754833|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
754742|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754743|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754744|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754745|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754746|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754747|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754748|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754749|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754750|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754751|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754752|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
764754|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
754753|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754754|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754755|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754756|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754757|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754758|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754759|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754760|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754761|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754762|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754763|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754764|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754765|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754766|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754767|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754768|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754769|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754770|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754771|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754772|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754773|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754774|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754775|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
755084|NCT01583543|O1|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib therapy.
765066|NCT01536405|B3|Baseline|Total|Total of all reporting groups
754776|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754777|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754778|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754779|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754780|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754781|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754782|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754783|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754784|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754785|NCT01585441|O2|Outcome|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754786|NCT01585441|O1|Outcome|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754787|NCT01585441|E2|Reported Event|Placebo|"Participants randomly assigned to the placebo arm will instructed to take one capsule daily for three months.~Placebo: Capsule with no active ingredients to mimic finasteride"
754834|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
754788|NCT01585441|E1|Reported Event|Finasteride 5 mg|"Participants randomly assigned to the finasteride 5 mg arm were instructed to take one capsule daily for three months.~Finasteride: Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules."
754789|NCT01585428|B3|Baseline|Total|Total of all reporting groups
754790|NCT01585428|B2|Baseline|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754791|NCT01585428|B1|Baseline|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754792|NCT01585428|P2|Participant Flow|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
755029|NCT01584479|B4|Baseline|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
754793|NCT01585428|P1|Participant Flow|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754794|NCT01585428|O2|Outcome|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754795|NCT01585428|O1|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754796|NCT01585428|O2|Outcome|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754808|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754835|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
754797|NCT01585428|O1|Outcome|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754798|NCT01585428|E2|Reported Event|NonCervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754799|NCT01585428|E1|Reported Event|Cervical|"Patients will receive a non-myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous (IV) infusion of Young tumor infiltrating lymphocytes (TIL) plus high dose IV aldesleukin.~Fludarabine: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.~Young TIL: Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).~Aldesleukin: Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)."
754989|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755085|NCT01583543|O1|Outcome|Olaparib|This group of patients with metastatic Ewing sarcoma received single agent olaparib.
754800|NCT01585324|B1|Baseline|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
754801|NCT01585324|P1|Participant Flow|Peginterferon Alpha-2a + Ribavirin|Participants infected with hepatitis C virus (HCV) genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 micrograms (mcg) subcutaneously once a week and ribavirin tablet, 1000-1200 milligrams (mg) by body weight (1000 mg if weight less than (<) 75 kilogram [kg]; 1200 mg if weight greater than or equal to (≥) 75 kg) orally split into 2 daily doses, for a total of 48 weeks.
754802|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754803|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754804|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754805|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754806|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754807|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754809|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754810|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754811|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754812|NCT01585324|O2|Outcome|Participants Without SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, and did not achieve SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
755080|NCT01583647|E1|Reported Event|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
754813|NCT01585324|O1|Outcome|Participants With SVR|Included all participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, but achieved SVR after treatment with a combination therapy of peginterferon alpha-2a at a dose of 180 mcg subcutaneously once a week and ribavirin 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally once daily in 2 divided doses, for a total of 48 weeks. SVR response was defined as a disappearance of HCV viral load 24 weeks after the end of the treatment.
754814|NCT01585324|O1|Outcome|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
754815|NCT01585324|E1|Reported Event|Peginterferon Alpha-2a + Ribavirin|Participants infected with HCV genotype 1, who were either treatment naïve or failed to respond to previous combination therapy with interferon and ribavirin, were included in the study. These participants were treated with a combination therapy of peginterferon alpha-2a injection at a dose of 180 mcg subcutaneously once a week and ribavirin tablet, 1000-1200 mg by body weight (1000 mg if weight <75 kg; 1200 mg if weight ≥75 kg) orally split into 2 daily doses, for a total of 48 weeks.
754816|NCT01585272|B1|Baseline|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754817|NCT01585272|P1|Participant Flow|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754818|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754819|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754820|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754821|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754822|NCT01585272|O1|Outcome|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754823|NCT01585272|E1|Reported Event|Rivastigmine|Eligible patients, who are under rivastigmine capsule 3 mg b.i.d. treatment for 4 weeks before Visit 2, will be recruited, followed by treatment switch from oral capsule to transdermal patch for 48 weeks maintenance treatment.
754824|NCT01585038|B3|Baseline|Total|Total of all reporting groups
754825|NCT01585038|B2|Baseline|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
754826|NCT01585038|B1|Baseline|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
754827|NCT01585038|P2|Participant Flow|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
754828|NCT01585038|P1|Participant Flow|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
754829|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
754830|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
754831|NCT01585038|O2|Outcome|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
754836|NCT01585038|O1|Outcome|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
754837|NCT01585038|E2|Reported Event|Rilpivirine|"Rilpivirine 25mg given daily with meals for 30 days~Rilpivirine: 25mg orally once daily"
754838|NCT01585038|E1|Reported Event|Efavirenz|"Efavirenz 600mg given nightly without food for 30 days~Efavirenz: 600mg orally every evening"
754839|NCT01584843|B5|Baseline|Total|Total of all reporting groups
754840|NCT01584843|B4|Baseline|GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754841|NCT01584843|B3|Baseline|GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD or with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
755081|NCT01583543|B1|Baseline|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
754842|NCT01584843|B2|Baseline|GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754843|NCT01584843|B1|Baseline|Non-treatment, Then GSK1358820|Participants (par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD or with a BSA >=20 PD and <50 PD received no treatment from the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754844|NCT01584843|P6|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754845|NCT01584843|P5|Participant Flow|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754846|NCT01584843|P4|Participant Flow|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754847|NCT01584843|P3|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
755480|NCT01581684|E8|Reported Event|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
754848|NCT01584843|P2|Participant Flow|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754849|NCT01584843|P1|Participant Flow|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754990|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755173|NCT01583101|B3|Baseline|Total|Total of all reporting groups
754850|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754851|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754852|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754853|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754854|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754855|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754982|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755012|NCT01584544|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
754856|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754857|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
755028|NCT01584479|B5|Baseline|Total|Total of all reporting groups
754858|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754859|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754860|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754861|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754862|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754863|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754983|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755013|NCT01584544|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
754864|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754865|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
755250|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
754866|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754867|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754868|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754869|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754870|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754871|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754888|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754872|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754906|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754873|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754874|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754875|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754876|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754877|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754878|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754879|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754969|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755014|NCT01584544|E5|Reported Event|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
754880|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754881|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754882|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754883|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754884|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754885|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754886|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754887|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754970|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754971|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754889|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754890|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754891|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754892|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754893|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754894|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754895|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754896|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754972|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754984|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754905|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754897|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754898|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754899|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754900|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754901|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754902|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754903|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754904|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754973|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755008|NCT01584544|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
754907|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754908|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754909|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754910|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754911|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754912|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754974|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754975|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754913|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754930|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754914|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754915|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754916|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754917|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754918|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754919|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754920|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754976|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755009|NCT01584544|O5|Outcome|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
758517|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
754929|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754921|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754922|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754923|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754924|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754925|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754926|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754927|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754928|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754977|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755010|NCT01584544|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
754931|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754932|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754933|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754934|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754935|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754936|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754978|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754979|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754937|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754985|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754986|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
765718|NCT01534910|P1|Participant Flow|Sugar Pill|"placebo~placebo: placebo"
754938|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754939|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754940|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754941|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754942|NCT01584843|O4|Outcome|BSA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754943|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754944|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754980|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755011|NCT01584544|O3|Outcome|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
758518|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
754987|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754988|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755251|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
754945|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754946|NCT01584843|O6|Outcome|BSA >=20 PD and <50 PD: GSK1358820 5.0 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754947|NCT01584843|O5|Outcome|BSA >=20 PD and <50 PD: GSK1358820 2.5 U|Par with a BSA >=20 PD and <50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754948|NCT01584843|O4|Outcome|SA >=20 PD and <50 PD: Non-treatment, Then GSK1358820|Par with a BSA >=20 PD and <50 PD received no treatment at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 2.5 U or 5.0 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754949|NCT01584843|O3|Outcome|BSA >=10 PD and <20 PD: GSK1358820 2.5 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754950|NCT01584843|O2|Outcome|BSA >=10 PD and <20 PD: GSK1358820 1.25 U|Par with a BSA >=10 PD and <20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754951|NCT01584843|O1|Outcome|BSA >=10 PD and <20 PD: Non-treatment, Then GSK1358820|Participants (Par) with a Baseline strabismus angle (BSA) >=10 prism dioptre (PD) and <20 PD received no treatment at the start of the First Treatment Period (FTP). Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U) or 2.5 U, at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754952|NCT01584843|E5|Reported Event|GSK1358820 5.0 U|Par with a BSA greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 5.0 U or 10.0 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754981|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755066|NCT01583894|O1|Outcome|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
758519|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
754953|NCT01584843|E4|Reported Event|GSK1358820 2.5 U|Participants with BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received the first injection of GSK1358820 2.5 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 2.5 U or 5.0, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754954|NCT01584843|E3|Reported Event|GSK1358820 1.25 U|Par with a BSA greater than or equal to 10 PD and less than 20 PD received the first injection of GSK1358820 1.25 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye at the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received an additional injection of GSK1358820, either 1.25 U or 2.5 U, at the same site and in the same eye as the previous injection, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the STP to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 3 injections.
754955|NCT01584843|E2|Reported Event|Non-treatment, Then GSK1358820|Par with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the FTP. Par who met the additional injection criteria at 4 weeks after the start of the FTP received the injection of GSK1358820, either 1.25 Units (U), 2.5 U, or 5.0 U at one site of the medial rectus muscle or the lateral rectus muscle of the affected eye, then were observed for 12-24 weeks. Par who met the re-injection criteria at 12-24 weeks after the last injection (of the FTP) entered the Second Treatment Period (STP) to receive the re-injection at an appropriate dose level selected by the investigator from the prior dose level, then were observed for 24 weeks. Par who did not meet the re-injection criteria were observed for 24 more weeks. Par received a maximum of 2 injections.
754956|NCT01584843|E1|Reported Event|Non-treatment|Participants (par) with a BSA of greater than or equal to 10 PD and less than 20 PD or greater than or equal to 20 PD and less than 50 PD received no treatment from the start of the First Treatment Period (FTP). Par were re-evaluated at Week 4 and Weeks 12-24. Par who did not meet the injection criteria at any time point remained in the FTP group and were observed up to study Week 52.
754957|NCT01584648|B3|Baseline|Total|Total of all reporting groups
754958|NCT01584648|B2|Baseline|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754959|NCT01584648|B1|Baseline|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754960|NCT01584648|P2|Participant Flow|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754961|NCT01584648|P1|Participant Flow|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754962|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754963|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754964|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754965|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754966|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754967|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754968|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
755067|NCT01583894|E1|Reported Event|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
754991|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754992|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754993|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754994|NCT01584648|O2|Outcome|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754995|NCT01584648|O1|Outcome|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754996|NCT01584648|E2|Reported Event|Dabrafenib + Placebo|Participants received dabrafenib 150 mg HPMC capsules orally BID, once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib placebo once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754997|NCT01584648|E1|Reported Event|Dabrafenib + Trametinib|Participants received dabrafenib 150 milligram (mg) HPMC capsules orally twice daily (BID), once in the morning and a second dose approximately 12 hours after the morning dose, and trametinib 2 mg once daily in the morning. Treatment was continued until disease progression, death, unacceptable toxicity, or withdrawal of consent.
754998|NCT01584544|B6|Baseline|Total|Total of all reporting groups
754999|NCT01584544|B5|Baseline|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755000|NCT01584544|B4|Baseline|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755001|NCT01584544|B3|Baseline|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755002|NCT01584544|B2|Baseline|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755003|NCT01584544|B1|Baseline|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755004|NCT01584544|P5|Participant Flow|1650mg|"capecitabine 1650mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755005|NCT01584544|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755006|NCT01584544|P3|Participant Flow|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755007|NCT01584544|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755015|NCT01584544|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755016|NCT01584544|E3|Reported Event|1350mg|"capecitabine 1300mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755017|NCT01584544|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755018|NCT01584544|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-25 combined with concurrent radiotherapy will be given to enrolled patients.~capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation"
755019|NCT01584518|B3|Baseline|Total|Total of all reporting groups
755020|NCT01584518|B2|Baseline|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
755021|NCT01584518|B1|Baseline|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
755022|NCT01584518|P2|Participant Flow|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
755023|NCT01584518|P1|Participant Flow|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
755024|NCT01584518|O2|Outcome|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
755025|NCT01584518|O1|Outcome|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
755026|NCT01584518|E2|Reported Event|Non CHF Peptide|Diuresis based on clinical judgement without data for CHF-P
755027|NCT01584518|E1|Reported Event|CHF Peptide|"Diuresis based on CHF-P~Furosemide: Based on clinical standard per clinician"
755030|NCT01584479|B3|Baseline|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
755031|NCT01584479|B2|Baseline|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755032|NCT01584479|B1|Baseline|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755033|NCT01584479|P4|Participant Flow|High Risk Control Group|"2 visits - High Risk 1,847 evaluable subjects~High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
755034|NCT01584479|P3|Participant Flow|High Risk Experimental Group|"1 visit - High Risk 852 evaluable subjects~High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
755035|NCT01584479|P2|Participant Flow|Low Risk Control Group|"2 visits - Low Risk 1,668 evaluable subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755036|NCT01584479|P1|Participant Flow|Low Risk Experimental Group|"1 visit - Low Risk 732 evaluable subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755037|NCT01584479|O4|Outcome|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
755038|NCT01584479|O3|Outcome|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
755039|NCT01584479|O2|Outcome|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755040|NCT01584479|O1|Outcome|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755041|NCT01584479|E4|Reported Event|High Risk Control Group|"2 visits - High Risk~~800 subjects High Risk Control Group = 2 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
755042|NCT01584479|E3|Reported Event|High Risk Experimental Group|"1 visit - High Risk~~800 subjects High Risk Experimental Group = 1 visit intervention, one or more of the following risk factors: history of periodontitis, smoker or diabetic, IL-1 genotype (+)"
755043|NCT01584479|E2|Reported Event|Low Risk Control Group|"2 visits - Low Risk~~1200 subjects~- Low risk Control Group = 2 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755044|NCT01584479|E1|Reported Event|Low Risk Experimental Group|"1 visit - Low Risk~~1200 subjects~- Low Risk Experimental Group = 1 visit intervention, no history of periodontitis, non-smoker, non-diabetic, IL-1 genotype (-)"
755045|NCT01584232|B3|Baseline|Total|Total of all reporting groups
755046|NCT01584232|B2|Baseline|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755047|NCT01584232|B1|Baseline|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755481|NCT01581684|E7|Reported Event|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755048|NCT01584232|P2|Participant Flow|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755049|NCT01584232|P1|Participant Flow|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755050|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755051|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755052|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755082|NCT01583543|P1|Participant Flow|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
755083|NCT01583543|O1|Outcome|Olaparib|"400mg PO BID Continuous~Olaparib: 400mg PO BID Continuous"
767098|NCT01527513|O1|Outcome|Placebo|Placebo QD
755053|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755054|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755055|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755056|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755057|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755058|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755059|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755060|NCT01584232|O2|Outcome|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755061|NCT01584232|O1|Outcome|LY2189265 + OAM|"LY2189265: 0.75 mg, administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755062|NCT01584232|E2|Reported Event|Insulin Glargine + OAM|"Insulin glargine: dose based on targeting fasting blood glucose ≤110 milligrams per deciliter (mg/dL), administered subcutaneously (SC), once daily for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755063|NCT01584232|E1|Reported Event|LY2189265 + OAM|"LY2189265: 0.75 milligrams (mg), administered subcutaneously (SC), once weekly for 26 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of oral antihyperglycemic medication (OAM) throughout the study. OAMs included sulfonylureas (SU; glibenclamide, gliclazide, or glimepiride) and/or biguanides (BG; metformin or buformin)."
755064|NCT01583894|B1|Baseline|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
755065|NCT01583894|P1|Participant Flow|Chronic Pain Patients|Patients suffering from chronic intractable pain of the trunk and/or limbs for a duration of at least 6 months
755068|NCT01583647|B1|Baseline|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755069|NCT01583647|P2|Participant Flow|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755070|NCT01583647|P1|Participant Flow|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755071|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755072|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755073|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755074|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755075|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755076|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755077|NCT01583647|O2|Outcome|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755078|NCT01583647|O1|Outcome|MK-0524A 1 g/20 mg (Panel A)|Single oral dose of 1 tablet of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755079|NCT01583647|E2|Reported Event|MK-0524A 2 g/40 mg (Panel B)|Single oral dose of 2 tablets of MK-0524A. Each tablet contained Extended Release (ER) Niacin 1g and laropiprant 20 mg
755086|NCT01583543|O1|Outcome|Olaparib|Patients with metastatic Ewing sarcoma who had previously received at least one line of chemotherapy were enrolled.
755087|NCT01583543|E1|Reported Event|Olaparib|400 mg PO BID Continuous Olaparib
755088|NCT01583530|B7|Baseline|Total|Total of all reporting groups
755089|NCT01583530|B6|Baseline|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755090|NCT01583530|B5|Baseline|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755091|NCT01583530|B4|Baseline|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755092|NCT01583530|B3|Baseline|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755093|NCT01583530|B2|Baseline|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755094|NCT01583530|B1|Baseline|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755095|NCT01583530|P6|Participant Flow|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755096|NCT01583530|P5|Participant Flow|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755097|NCT01583530|P4|Participant Flow|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755098|NCT01583530|P3|Participant Flow|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755099|NCT01583530|P2|Participant Flow|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755100|NCT01583530|P1|Participant Flow|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755101|NCT01583530|O6|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755102|NCT01583530|O5|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755103|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755104|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755105|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755106|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755107|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755108|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755109|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755110|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755111|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755112|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755113|NCT01583530|O2|Outcome|Belimumab SC x 1 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755482|NCT01581684|E6|Reported Event|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755114|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755115|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755116|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755117|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755118|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755119|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755120|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755121|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755122|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755123|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755124|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755125|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755126|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755127|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755128|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755129|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755130|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755131|NCT01583530|O2|Outcome|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755132|NCT01583530|O1|Outcome|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755133|NCT01583530|O4|Outcome|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755134|NCT01583530|O3|Outcome|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755135|NCT01583530|O2|Outcome|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755136|NCT01583530|O1|Outcome|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755252|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
755137|NCT01583530|E6|Reported Event|Belimumab SC 1 x 200 mg Weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
755138|NCT01583530|E5|Reported Event|Belimumab SC 2 x 120 mg Weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
755139|NCT01583530|E4|Reported Event|Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
755140|NCT01583530|E3|Reported Event|Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
755141|NCT01583530|E2|Reported Event|Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
755142|NCT01583530|E1|Reported Event|Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
755143|NCT01583452|B3|Baseline|Total|Total of all reporting groups
755144|NCT01583452|B2|Baseline|No Intervention|By observing the clinical evolution of the participants not given chewing gum as prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
755145|NCT01583452|B1|Baseline|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
755146|NCT01583452|P2|Participant Flow|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
755147|NCT01583452|P1|Participant Flow|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
755148|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
755149|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
755150|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
755151|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, besides the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
755152|NCT01583452|O2|Outcome|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
755153|NCT01583452|O1|Outcome|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
755154|NCT01583452|O2|Outcome|Control Group|The time between the end of surgery and the discharge of the patient measured in hours.
755155|NCT01583452|O1|Outcome|Chewing Gum Group|The time between the end of the surgery and the discharge of the patients, measured in hours.
755483|NCT01581684|E5|Reported Event|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755156|NCT01583452|E2|Reported Event|No Intervention|By observing the clinical evolution of the participants not given chewing gum as a prevention for post-operative ileus, and just given the standard pharmacologic treatment and post-operative care.
755157|NCT01583452|E1|Reported Event|Chewing Gum Group|"Group of patients given chewing gum as part of the treatment for prevention of post-operative ileus right after surgery, plus the standard pharmacologic treatment and post-operative care.~Chewing Gum: The use of chewing gum as a preventive measure for post-operative ileus"
755158|NCT01583374|B4|Baseline|Total|Total of all reporting groups
755159|NCT01583374|B3|Baseline|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
755160|NCT01583374|B2|Baseline|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
755161|NCT01583374|B1|Baseline|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
755162|NCT01583374|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
755163|NCT01583374|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
755164|NCT01583374|P1|Participant Flow|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
755165|NCT01583374|O3|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase..
755166|NCT01583374|O2|Outcome|Apremilast 20 mg|Participants initially randomized to 20 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
755167|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
755168|NCT01583374|O2|Outcome|Apremilast 30 mg|Participants initially randomized to 30 mg apremilast PO BID in the 24-week placebo-controlled treatment phase.
755169|NCT01583374|O1|Outcome|Placebo|Participants initially randomized to placebo by mouth (PO) twice daily (BID) in the 24-week placebo-controlled treatment phase.
755170|NCT01583374|E3|Reported Event|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
755171|NCT01583374|E2|Reported Event|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo controlled treatment phase.
755172|NCT01583374|E1|Reported Event|Placebo|Participants initially randomized to receive placebo tablets twice daily.
755174|NCT01583101|B2|Baseline|Receiving Non-highlighted Prompts|These patients received prompts that were not highlighted.
755175|NCT01583101|B1|Baseline|Receiving Highlighted Prompts|These patients received highlighted prompts.
755176|NCT01583101|P2|Participant Flow|Non-highlighted Prompts|Physicians received prompts that were not highlighted.
755177|NCT01583101|P1|Participant Flow|Highlighted Prompts|Physicians received highlighted prompts.
755178|NCT01583101|O2|Outcome|Receiving Non-highlighted Prompts|Prompts received by physicians were not highlighted.
755179|NCT01583101|O1|Outcome|Receiving Highlighted Prompts|Prompts received by physicians were highlighted.
755180|NCT01583101|E2|Reported Event|Non-highlighted Prompts|These patients received prompts that were not highlighted.
755181|NCT01583101|E1|Reported Event|Highlighted Prompts|These patients received highlighted prompts.
755182|NCT01582945|B1|Baseline|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
755183|NCT01582945|P1|Participant Flow|Treatment-resistant Depression Patients|Outpatient sample of patients (18-65 years old) with treatment-resistant major depressive disorder (TRD).
755184|NCT01582945|O1|Outcome|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg over the course of 45 minutes, twice a week for 3 weeks. Participants received this dosage for the first three of six IV ketamine infusions. If participants do not experience an improvement of greater or equal to 30% in HAM-D scores after the first three infusions, the dose will be increased to 0.75mg/kg for the subsequent three infusions.~Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
755185|NCT01582945|E1|Reported Event|Ketamine IV|"Patients will receive open label augmentation with IV Ketamine at 0.5mg/kg, twice a week for 3 weeks~Ketamine: Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen"
755186|NCT01582854|B3|Baseline|Total|Total of all reporting groups
755187|NCT01582854|B2|Baseline|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755188|NCT01582854|B1|Baseline|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755189|NCT01582854|P2|Participant Flow|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755190|NCT01582854|P1|Participant Flow|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755191|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755192|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755193|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755194|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755340|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755195|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755196|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755197|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755198|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755199|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755200|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755201|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755202|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755203|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755204|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755205|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755206|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755207|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755208|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755253|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
755209|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755210|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755211|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755212|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755213|NCT01582854|O2|Outcome|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755214|NCT01582854|O1|Outcome|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755215|NCT01582854|E2|Reported Event|Placebo|Actovegin placebo-matching solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin placebo-matching, tablets, orally, 3 times a day for up to 6 months.
755216|NCT01582854|E1|Reported Event|Actovegin|Actovegin 2000 mg solution, intravenous (IV) infusion for up to 20 days followed by 2 actovegin 200 mg, tablets, orally, 3 times a day for up to 6 months.
755217|NCT01582789|B1|Baseline|Overall Study Group Prior to Dispense|All subjects prior to dispense of first set of study lenses
755218|NCT01582789|P2|Participant Flow|Senofilcon A, Then Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
755219|NCT01582789|P1|Participant Flow|Enfilcon A, Then Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
755220|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
755221|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
755222|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
755223|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
755224|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
755225|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
755226|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
755227|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
755228|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as second pair
755229|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as second pair
755230|NCT01582789|O2|Outcome|Senofilcon A|Subject wears senofilcon A daily wear soft contact lens as first pair
755231|NCT01582789|O1|Outcome|Enfilcon A|Subject wears enfilcon A daily wear soft contact lens as first pair
755232|NCT01582789|E2|Reported Event|Senofilcon A/Enfilcon A|"senofilcon A daily wear soft contact lens 1st then cross over and subject wears the enfilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
758520|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
755233|NCT01582789|E1|Reported Event|Enfilcon A/Senofilcon A|"enfilcon A daily wear soft contact lens 1st then cross over and subject wears the senofilcon A daily wear soft contact lens 2nd~enfilcon A: enfilcon A daily wear soft contact lens~senofilcon A: senofilcon A daily wear soft contact lens"
755234|NCT01582490|B3|Baseline|Total|Total of all reporting groups
755235|NCT01582490|B2|Baseline|Instillation - EXPAREL|"Group 1 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be instilled into each breast pocket at the beginning of surgery.~Infiltration - EXPAREL: IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
755236|NCT01582490|B1|Baseline|Infiltration - EXPAREL|"Group 2 will receive diluted EXPAREL (i.e., the contents of one 20 mL vial, 266 mg, diluted with 20 mL of preservative-free 0.9% normal saline to a total of 40 mL) for postsurgical analgesia. Half of the resulting mixture (i.e., 20 mL) will be administered via local infiltration into each surgical site per the surgeon's normal practice at the beginning of surgery.~Instillation - EXPAREL: Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed."
755237|NCT01582490|P2|Participant Flow|Instillation - EXPAREL|Subjects received EXPAREL 266 mg via instillation.
755238|NCT01582490|P1|Participant Flow|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
755239|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
755240|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
755241|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
755242|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
755243|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
755244|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
755245|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
755246|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
755247|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
755248|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
755249|NCT01582490|O2|Outcome|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
755254|NCT01582490|O1|Outcome|Infiltration - EXPAREL|Subjects received EXPAREL 266 mg via infiltration.
755255|NCT01582490|E2|Reported Event|Instillation - EXPAREL|Subjects received 266 mg EXPAREL via instillation
755256|NCT01582490|E1|Reported Event|Infiltration - EXPAREL|Subjects received 266 mg EXPAREL via infiltration
755257|NCT01582477|B3|Baseline|Total|Total of all reporting groups
755258|NCT01582477|B2|Baseline|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755259|NCT01582477|B1|Baseline|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755260|NCT01582477|P2|Participant Flow|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755261|NCT01582477|P1|Participant Flow|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755262|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755263|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755264|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755265|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755266|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755267|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755268|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755269|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755270|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755271|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755272|NCT01582477|O2|Outcome|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755273|NCT01582477|O1|Outcome|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755274|NCT01582477|E2|Reported Event|EXPAREL 40 mL|Group receiving EXPAREL 40 mL
755275|NCT01582477|E1|Reported Event|EXPAREL 20 mL|Group receiving EXPAREL 20 mL
755276|NCT01582308|B1|Baseline|All Enrolled Participants|
755277|NCT01582308|P10|Participant Flow|Treatment Sequence 10|Placebo in Period 1 followed by saxagliptin 5 mg in Period 2 followed by sitagliptin 100 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by vildagliptin 50 mg in Period 5
755278|NCT01582308|P9|Participant Flow|Treatment Sequence 9|Vildagliptin 50 mg BID in Period 1 followed by sitagliptin 100 mg in Period 2 followed by placebo in Period 3 followed by vildagliptin 50 mg in Period 4 followed by saxagliptin 5 mg in Period 5
755279|NCT01582308|P8|Participant Flow|Treatment Sequence 8|Vildagliptin 50 mg in Period 1 followed by placebo in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by saxagliptin 5 mg in Period 4 followed by sitagliptin 100 mg in Period 5
755280|NCT01582308|P7|Participant Flow|Treatment Sequence 7|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by vildagliptin 50 mg in Period 3 followed by sitagliptin 100 mg in Period 4 followed by placebo in Period 5
755281|NCT01582308|P6|Participant Flow|Treatment Sequence 6|Sitagliptin 100 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by saxagliptin 5 mg in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg BID in Period 5
755282|NCT01582308|P5|Participant Flow|Treatment Sequence 5|Placebo in Period 1 followed by sitagliptin 100 mg in Period 2 followed by vildagliptin 50 mg in Period 3 followed by vildagliptin 50 mg BID in Period 4 followed by saxagliptin 5 mg in Period 5
757846|NCT01570309|B1|Baseline|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
755283|NCT01582308|P4|Participant Flow|Treatment Sequence 4|Vildagliptin 50 mg BID in Period 1 followed by placebo in Period 2 followed by saxagliptin 5 mg in Period 3 followed by vildagliptin 50 mg in Period 4 followed by sitagliptin 100 mg in Period 5
755284|NCT01582308|P3|Participant Flow|Treatment Sequence 3|Vildagliptin 50 mg in Period 1 followed by vildagliptin 50 mg BID in Period 2 followed by sitagliptin 100 mg in Period 3 followed by saxagliptin 5 mg in Period 4 followed by placebo in Period 5
755285|NCT01582308|P2|Participant Flow|Treatment Sequence 2|Saxagliptin 5 mg in Period 1 followed by vildagliptin 50 mg in Period 2 followed by placebo in Period 3 followed by sitagliptin 100 mg in Period 4 followed by vildagliptin 50 mg BID in Period 5
755286|NCT01582308|P1|Participant Flow|Treatment Sequence 1|Sitagliptin 100 mg in Period 1 followed by saxagliptin 5 mg in Period 2 followed by vildagliptin 50 mg BID in Period 3 followed by placebo in Period 4 followed by vildagliptin 50 mg in Period 5
755287|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
755288|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
755289|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
755290|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
755291|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
755292|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
755293|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
755294|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
755295|NCT01582308|O1|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
755296|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
755297|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
755298|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
755299|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
755300|NCT01582308|O5|Outcome|Placebo|Placebo to sitagliptin daily for 5 days
755301|NCT01582308|O4|Outcome|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
755302|NCT01582308|O3|Outcome|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
755303|NCT01582308|O2|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
755304|NCT01582308|O1|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
755305|NCT01582308|E5|Reported Event|Placebo|Placebo to sitagliptin daily for 5 days
755306|NCT01582308|E4|Reported Event|Vildagliptin 50 mg BID|Vildagliptin 50 mg twice daily for 5 days
755307|NCT01582308|E3|Reported Event|Vildagliptin 50 mg|Vildagliptin 50 mg daily for 5 days
755308|NCT01582308|E2|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg daily for 5 days
755398|NCT01581684|B11|Baseline|Total|Total of all reporting groups
755309|NCT01582308|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg daily for 5 days
755310|NCT01582282|B4|Baseline|Total|Total of all reporting groups
755311|NCT01582282|B3|Baseline|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755312|NCT01582282|B2|Baseline|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755313|NCT01582282|B1|Baseline|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755314|NCT01582282|P3|Participant Flow|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755315|NCT01582282|P2|Participant Flow|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755316|NCT01582282|P1|Participant Flow|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755317|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755318|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755319|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755320|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755321|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755322|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755323|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755324|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755325|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755326|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755327|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755328|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755329|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755330|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755331|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755332|NCT01582282|O3|Outcome|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755333|NCT01582282|O2|Outcome|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755334|NCT01582282|O1|Outcome|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755335|NCT01582282|E3|Reported Event|Placebo|Placebo, orange-flavored formulation with excipients of the Metamucil formulation without psyllium BID
755336|NCT01582282|E2|Reported Event|6.8g Psyllium BID|Metamucil, psyllium 6.8g BID (13.6g/day)
755337|NCT01582282|E1|Reported Event|Psyllium 3.4g BID|Metamucil, psyllium 3.4g BID (6.8g/day)
755338|NCT01582243|B1|Baseline|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755339|NCT01582243|P1|Participant Flow|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755341|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755342|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755343|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755344|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755345|NCT01582243|O1|Outcome|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755346|NCT01582243|E1|Reported Event|Vildagliptin Plus Metformin (SPC)|Eligible participants received oral vildagliptin 50 mg plus metformin 500 mg (SPC) twice daily from week 1 to week 24.
755347|NCT01582178|B3|Baseline|Total|Total of all reporting groups
755348|NCT01582178|B2|Baseline|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755349|NCT01582178|B1|Baseline|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755350|NCT01582178|P2|Participant Flow|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755351|NCT01582178|P1|Participant Flow|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755352|NCT01582178|O2|Outcome|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755353|NCT01582178|O1|Outcome|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755354|NCT01582178|E2|Reported Event|Cool Water Immersion Colonoscopy|Colonoscopy using purely room temperature water (20-24°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755355|NCT01582178|E1|Reported Event|Warm Water Immersion Colonoscopy|Colonoscopy using purely warm water (37°C) infusion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
755356|NCT01582139|B3|Baseline|Total|Total of all reporting groups
755399|NCT01581684|B10|Baseline|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
755400|NCT01581684|B9|Baseline|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
755357|NCT01582139|B2|Baseline|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
755358|NCT01582139|B1|Baseline|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
755359|NCT01582139|P2|Participant Flow|Experimental First, Then Control|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
755360|NCT01582139|P1|Participant Flow|Control First, Then Experimental|"Control, SSM+HMM: A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.~Experimental, Heart-Rate Informed SSM: An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate"
755361|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
755362|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
755363|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
755364|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
755365|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
755366|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
755367|NCT01582139|O2|Outcome|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
755368|NCT01582139|O1|Outcome|Experimental: Heart-Rate Informed SSM+HMM|"An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
755369|NCT01582139|E2|Reported Event|Experimental: Heart Rate Informed SSM+HMM|"Experimental:~An experimental condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is informed about heart rate~Heart rate informed SSM+HMM: The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes."
755370|NCT01582139|E1|Reported Event|Control: SSM+HMM|A control condition involving an exercise session where the Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) is not informed about heart rate.
755371|NCT01582100|B1|Baseline|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
755372|NCT01582100|P1|Participant Flow|GERD Subjects With Nausea|Subjects who present with GERD along with nausea (with or without vomiting)
755373|NCT01582100|O1|Outcome|Single Arm Subjects With GERD/Nausea|This is a single arm study measuring the incidence and severity of nausea with or without vomiting in patients with GERD before and after treatment with Reletex
755374|NCT01582100|E1|Reported Event|Wrist Discomfort|subject did not like the feel of the device on wrist
755375|NCT01582009|B1|Baseline|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755401|NCT01581684|B8|Baseline|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
771216|NCT01510652|B3|Baseline|Total|Total of all reporting groups
755376|NCT01582009|P1|Participant Flow|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755377|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755378|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755379|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755380|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755381|NCT01582009|O1|Outcome|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755382|NCT01582009|E1|Reported Event|Arm I: Oral Panobinostat and Oral Everolimus|"Patients receive oral panobinostat once daily on days 1, 3, 4, 8, 10, and 12 and oral everolimus once daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~panobinostat: Given orally~everolimus: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~liquid chromatography: Correlative studies~mass spectrometry: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~immunohistochemistry staining method: Correlative studies"
755428|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
757847|NCT01570309|P2|Participant Flow|Sugar Pill|Matching placebo
755383|NCT01581931|B1|Baseline|Overall Study|This was an open-label, randomised, single dose, 2-way crossover trial with 2 treatments and 2 treatment sequences. The single dose administrations in each treatment period were separated by a washout period of at least 35 days.
755384|NCT01581931|P2|Participant Flow|Lina+Met FDC Tablet / Lina+Met Single Tablets|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in the first period. After a washout period of at least 35 days, the subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in period 2.
755385|NCT01581931|P1|Participant Flow|Lina+Met Single Tablets / Lina+Met FDC Tablet|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets in the first period. After a washout period of at least 35 days, the subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet in period 2.
755386|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
755387|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
755388|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
755389|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
755390|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
755391|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
755392|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
755393|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
755394|NCT01581931|O2|Outcome|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
755395|NCT01581931|O1|Outcome|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
755396|NCT01581931|E2|Reported Event|Lina+Met FDC Tablet|Subjects are treated with a 2.5 mg linagliptin / 500 mg metformin fixed-dose-combination (FDC) tablet
755397|NCT01581931|E1|Reported Event|Lina+Met Single Tablets|Subjects are treated with single linagliptin 2.5 mg and metformin 500 mg tablets
755402|NCT01581684|B7|Baseline|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755403|NCT01581684|B6|Baseline|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755404|NCT01581684|B5|Baseline|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755405|NCT01581684|B4|Baseline|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755406|NCT01581684|B3|Baseline|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755407|NCT01581684|B2|Baseline|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755408|NCT01581684|B1|Baseline|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
755409|NCT01581684|P10|Participant Flow|20/60mg PM|Single oral dose of 20/60mg of BI 411034 for participants who are poor metabolisers
755410|NCT01581684|P9|Participant Flow|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
755411|NCT01581684|P8|Participant Flow|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
755412|NCT01581684|P7|Participant Flow|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755413|NCT01581684|P6|Participant Flow|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755414|NCT01581684|P5|Participant Flow|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755415|NCT01581684|P4|Participant Flow|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755416|NCT01581684|P3|Participant Flow|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755417|NCT01581684|P2|Participant Flow|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755418|NCT01581684|P1|Participant Flow|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
755419|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
755420|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
755421|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
755422|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
755423|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755424|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755425|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755426|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755427|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755429|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
755430|NCT01581684|O11|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
755431|NCT01581684|O10|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
755432|NCT01581684|O9|Outcome|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
755433|NCT01581684|O8|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
755434|NCT01581684|O7|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755435|NCT01581684|O6|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755436|NCT01581684|O5|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755437|NCT01581684|O4|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755438|NCT01581684|O3|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755439|NCT01581684|O2|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755440|NCT01581684|O1|Outcome|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
755441|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
755442|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
755443|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
755444|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755445|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755446|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755447|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755448|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755449|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755450|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
755451|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
755452|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
755453|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755454|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755455|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755456|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755457|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755458|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755459|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
755460|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
755461|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
755462|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755463|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755464|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755465|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755466|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755467|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755468|NCT01581684|O9|Outcome|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
755469|NCT01581684|O8|Outcome|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
755470|NCT01581684|O7|Outcome|250mg EM|Single oral dose of 250mg of BI 411034 for participants who are extensive metabolisers
755471|NCT01581684|O6|Outcome|150mg EM|Single oral dose of 150mg of BI 411034 for participants who are extensive metabolisers
755472|NCT01581684|O5|Outcome|80mg EM|Single oral dose of 80mg of BI 411034 for participants who are extensive metabolisers
755473|NCT01581684|O4|Outcome|40mg EM|Single oral dose of 40mg of BI 411034 for participants who are extensive metabolisers
755474|NCT01581684|O3|Outcome|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755475|NCT01581684|O2|Outcome|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755476|NCT01581684|O1|Outcome|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755477|NCT01581684|E11|Reported Event|60mg PM|Single oral dose of 60mg of BI 411034 for participants who are poor metabolisers
755478|NCT01581684|E10|Reported Event|20mg PM|Single oral dose of 20mg of BI 411034 for participants who are poor metabolisers
755479|NCT01581684|E9|Reported Event|Placebo PM|A powder for oral solution in the same volume as the respective active medication group and participants who are poor metabolisers (PM)
758521|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
755484|NCT01581684|E4|Reported Event|20mg EM|Single oral dose of 20mg of BI 411034 for participants who are extensive metabolisers
755485|NCT01581684|E3|Reported Event|8mg EM|Single oral dose of 8mg of BI 411034 for participants who are extensive metabolisers
755486|NCT01581684|E2|Reported Event|2mg EM|Single oral dose of 2mg of BI 411034 for participants who are extensive metabolisers
755487|NCT01581684|E1|Reported Event|Placebo EM|A powder for oral solution in the same volume as the respective active medication group and participants who are extensive metabolisers (EM)
755488|NCT01581658|B5|Baseline|Total|Total of all reporting groups
755489|NCT01581658|B4|Baseline|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
755490|NCT01581658|B3|Baseline|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
755491|NCT01581658|B2|Baseline|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
755492|NCT01581658|B1|Baseline|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
755493|NCT01581658|P4|Participant Flow|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
755494|NCT01581658|P3|Participant Flow|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
755495|NCT01581658|P2|Participant Flow|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
755496|NCT01581658|P1|Participant Flow|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
755497|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
755498|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
755499|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
755500|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
755501|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
755502|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
755503|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
755504|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
755505|NCT01581658|O4|Outcome|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
755506|NCT01581658|O3|Outcome|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
755507|NCT01581658|O2|Outcome|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
755508|NCT01581658|O1|Outcome|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
755509|NCT01581658|E4|Reported Event|Severe Renal Impairment|25 mg empagliflozin taken as a single dose for patients with severe renal impairment
755510|NCT01581658|E3|Reported Event|Moderate Renal Impairment|25 mg empagliflozin taken as a single dose for patients with moderate renal impairment
755511|NCT01581658|E2|Reported Event|Mild Renal Impairment|25 mg empagliflozin taken as a single dose for patients with mild renal impairment
755512|NCT01581658|E1|Reported Event|Normal Renal Function|25 mg empagliflozin taken as a single dose for patients with normal renal function
755513|NCT01581437|B1|Baseline|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
755514|NCT01581437|P1|Participant Flow|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
755515|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter:"
755516|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter:"
755517|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: Outcome:78 patients enrolled multicenter"
755518|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
755519|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
755520|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter"
755521|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.~Outcome:78 patients enrolled multicenter."
755583|NCT01580618|B1|Baseline|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755522|NCT01581437|O1|Outcome|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
755523|NCT01581437|E1|Reported Event|64 Pole Basket Catheter|"all patients participating undergo mapping using the 64 pole basket catheter to assess for Atypical areas of drivers that may cause atrial fibrillation~64 pole basket catheter: The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy."
755524|NCT01581307|B1|Baseline|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
755525|NCT01581307|P1|Participant Flow|2nd Line Chemotherapy With Radiotherapy|"Administration of 2nd line chemotherapy will consist of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) will take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy is given every two weeks for 6‐10 cycles.~The goal of treatment with TheraSpheres is to allow a large dose of radiation to be delivered directly to the tumor(s) with less risk of toxic effects from radiation to other parts of the body or to healthy liver tissue.~FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin): The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.~TheraSpheres: TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors."
755526|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
755527|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
755528|NCT01581307|O1|Outcome|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
755529|NCT01581307|E1|Reported Event|2nd Line Chemotherapy With Radiotherapy|Administration of 2nd line chemotherapy consisted of a modified FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin) to take place at least 2 weeks after the completion of first‐line chemotherapy. Generally, second‐line chemotherapy was to be given every two weeks for 6‐10 cycles.
755531|NCT01581021|B2|Baseline|Laminar Hooks|Group treated with hooks in the thoracic spine
755532|NCT01581021|B1|Baseline|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
755533|NCT01581021|P2|Participant Flow|Laminar Hooks|Group treated with hooks in the thoracic spine
755534|NCT01581021|P1|Participant Flow|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
755535|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
755536|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
755537|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
755538|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
755539|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
755540|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
755541|NCT01581021|O2|Outcome|Laminar Hooks|Group treated with hooks in the thoracic spine
755542|NCT01581021|O1|Outcome|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
755543|NCT01581021|E2|Reported Event|Laminar Hooks|Group treated with hooks in the thoracic spine
755544|NCT01581021|E1|Reported Event|Thoracic Pedicle Screws|Group treated with pedicle screws in the thoracic spine
755545|NCT01581008|B3|Baseline|Total|Total of all reporting groups
755546|NCT01581008|B2|Baseline|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
755547|NCT01581008|B1|Baseline|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
755548|NCT01581008|P2|Participant Flow|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
755549|NCT01581008|P1|Participant Flow|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
755584|NCT01580618|P2|Participant Flow|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
755585|NCT01580618|P1|Participant Flow|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755550|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
755551|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
755552|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
755553|NCT01581008|O2|Outcome|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
755554|NCT01581008|O1|Outcome|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
755555|NCT01581008|E2|Reported Event|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
755556|NCT01581008|E1|Reported Event|CASA|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
755557|NCT01580995|B3|Baseline|Total|Total of all reporting groups
755558|NCT01580995|B2|Baseline|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
755559|NCT01580995|B1|Baseline|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
755560|NCT01580995|P2|Participant Flow|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
755561|NCT01580995|P1|Participant Flow|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
755562|NCT01580995|O2|Outcome|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
755563|NCT01580995|O1|Outcome|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
755564|NCT01580995|E2|Reported Event|Placebo|"Matching placebo twice daily~Placebo: Placebo tablet twice daily"
755565|NCT01580995|E1|Reported Event|Valacyclovir|"Valacyclovir 500 mg po bid~Valacyclovir: Valacyclovir 500 mg po bid"
755566|NCT01580904|B3|Baseline|Total|Total of all reporting groups
755567|NCT01580904|B2|Baseline|Control Group|Patients will not be followed by the pharmacist.
755568|NCT01580904|B1|Baseline|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
755569|NCT01580904|P2|Participant Flow|Control Group|Patients will not be followed by the pharmacist.
755570|NCT01580904|P1|Participant Flow|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care : Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
755571|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
755572|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
755573|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
755574|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
755575|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist by Pharmacotherapeutic monitoring and dosing parameters such as glucose and glycated hemoglobin.~Intervention: Pharmaceutical Care~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
755576|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
755577|NCT01580904|O2|Outcome|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
755578|NCT01580904|O1|Outcome|Control Group|Patients will not be followed by the pharmacist.
755579|NCT01580904|E2|Reported Event|Intervention Group|"Patients will be followed by the pharmacist.~Intervention: Pharmaceutical Care: Patients will be followed by the pharmacist by the Pharmaceutical Care Practice"
755580|NCT01580904|E1|Reported Event|Control Group|Patients will not be followed by the pharmacist.
755581|NCT01580618|B3|Baseline|Total|Total of all reporting groups
755582|NCT01580618|B2|Baseline|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
755586|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
755587|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755588|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
755589|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755590|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755591|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
755592|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755593|NCT01580618|O2|Outcome|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
755594|NCT01580618|O1|Outcome|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755595|NCT01580618|E2|Reported Event|TNKase|Loculated pleural effusion infused with TNK twice a day for three days.
755596|NCT01580618|E1|Reported Event|Normal Saline|Loculated pleural effusion infused with normal saline twice a day for three days.
755597|NCT01580592|B4|Baseline|Total|Total of all reporting groups
755598|NCT01580592|B3|Baseline|Placebo|Placebo: Placebo, s.c., every 4 weeks
755599|NCT01580592|B2|Baseline|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
755600|NCT01580592|B1|Baseline|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
755601|NCT01580592|P3|Participant Flow|Placebo|Placebo: Placebo, s.c., every 4 weeks
755602|NCT01580592|P2|Participant Flow|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
755603|NCT01580592|P1|Participant Flow|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
755604|NCT01580592|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
755605|NCT01580592|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
755606|NCT01580592|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
755607|NCT01580592|O3|Outcome|Placebo|Placebo: Placebo, s.c., every 4 weeks
755608|NCT01580592|O2|Outcome|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
755609|NCT01580592|O1|Outcome|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
755610|NCT01580592|E3|Reported Event|Placebo|Placebo: Placebo, s.c., every 4 weeks
755611|NCT01580592|E2|Reported Event|Omalizumab 300mg|Omalizumab: 300mg, s.c., every 4 weeks
755612|NCT01580592|E1|Reported Event|Omalizumab 150mg|Omalizumab: 150mg, s.c., every 4 weeks
755613|NCT01580488|B1|Baseline|All Study Participants|
755670|NCT01580306|B3|Baseline|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
755614|NCT01580488|P1|Participant Flow|All Study Participants|"Each of the 24 subjects received all 6 investigational products on small dermal test sites: Topical cream formulation B containing 20 mg/g LEO 35299 Topical cream formulation C containing 20 mg/g LEO 35299 Topical solution formulation E containing 10 mg/g LEO 35299 Topical solution formulation F containing 10 mg/g LEO 35299 Topical ointment containing 50 mcg/g calcipotriol Topical ointment vehicle"
755615|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
755616|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
755617|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
755618|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
755619|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
755620|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
755621|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
755622|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
755623|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
755624|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
755625|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
755626|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
755627|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
755628|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
755629|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
755630|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
755631|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
755632|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
755633|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
755634|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
755635|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
755636|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
755637|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
755638|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
755639|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
755640|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
755641|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
755642|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
755643|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
758522|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
755644|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
755645|NCT01580488|O6|Outcome|Daivonex® Ointment|Topical ointment vehicle
755646|NCT01580488|O5|Outcome|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
755647|NCT01580488|O4|Outcome|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
755648|NCT01580488|O3|Outcome|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
755649|NCT01580488|O2|Outcome|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
755650|NCT01580488|O1|Outcome|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
755651|NCT01580488|E6|Reported Event|Daivonex® Ointment|Topical ointment vehicle
755652|NCT01580488|E5|Reported Event|Daivonex® Ointment: Calcipotriol 50 Mcg/g Ointment|Topical ointment containing 50 mcg/g calcipotriol
755653|NCT01580488|E4|Reported Event|F LEO 35299 10 mg/g|"Topical solution formulation F containing 10 mg/g LEO 35299"
755654|NCT01580488|E3|Reported Event|E LEO 35299 10 mg/g|"Topical solution formulation E containing 10 mg/g LEO 35299"
755655|NCT01580488|E2|Reported Event|C LEO 35299 20 mg/g|"Topical cream formulation C containing 20 mg/g LEO 35299"
755656|NCT01580488|E1|Reported Event|B LEO 35299 20 mg/g|"Topical cream formulation B containing 20 mg/g LEO 35299"
755657|NCT01580423|B1|Baseline|Entire Study Population|Includes groups randomized to receive aprepitant first and inert powder first.
755658|NCT01580423|P2|Participant Flow|First Inert Powder, Then Aprepitant|Capsule of inert powder in first intervention period and capsule of aprepitant 125 mg in second intervention period.
755659|NCT01580423|P1|Participant Flow|First Aprepitant, Then Inert Powder|Capsule of aprepitant 125 mg in first intervention period and capsule of inert powder in second intervention period.
755660|NCT01580423|O2|Outcome|Inert Powder|Capsule containing insert powder
755661|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
755662|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
755663|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
755664|NCT01580423|O2|Outcome|Inert Powder|Capsule containing inert powder
755665|NCT01580423|O1|Outcome|Aprepitant|Capsule containing 125 mg of aprepitant
755666|NCT01580423|E2|Reported Event|Inert Powder|Capsule filled with inert powder
755667|NCT01580423|E1|Reported Event|Aprepitant|Capsule filled with 125 mg of aprepitant
755668|NCT01580306|B5|Baseline|Total|Total of all reporting groups
755669|NCT01580306|B4|Baseline|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
755671|NCT01580306|B2|Baseline|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
755672|NCT01580306|B1|Baseline|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
755673|NCT01580306|P4|Participant Flow|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
755674|NCT01580306|P3|Participant Flow|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
755675|NCT01580306|P2|Participant Flow|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
755676|NCT01580306|P1|Participant Flow|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
755677|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
755678|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
755679|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
755680|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
755681|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
755682|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
755683|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
755684|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
755685|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
755686|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
755687|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
755688|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
755689|NCT01580306|O4|Outcome|Severe Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 15-29 mL/min/1.73m2"
755690|NCT01580306|O3|Outcome|Moderate Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 30-59 mL/min/1.73m2"
755691|NCT01580306|O2|Outcome|Mild Renal Impairment|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate 60-89 mL/min/1.73m2"
755692|NCT01580306|O1|Outcome|Normal Renal Function|"Capsule for oral administration (120 mg Faldaprevir)~subjects with estimated glomerular filtration rate >= 90 mL/min/1.73m2"
755693|NCT01580306|E4|Reported Event|BI 201335 Relevant Treatment Dose (Severe Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 15-29 mL/min/1.73m2"
755694|NCT01580306|E3|Reported Event|BI 201335 Relevant Treatment Dose (Moderate Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 30-59 mL/min/1.73m2"
755695|NCT01580306|E2|Reported Event|BI 201335 Relevant Treatment Dose (Mild Renal Impairment)|"Capsule for oral administration~estimated glomerular filtration rate 60-89 mL/min/1.73m2"
755696|NCT01580306|E1|Reported Event|BI 201335 Relevant Treatment Dose (Normal Renal Function)|"Capsule for oral administration~estimated glomerular filtration rate >= 90 mL/min/1.73m2"
755697|NCT01580098|B3|Baseline|Total|Total of all reporting groups
755698|NCT01580098|B2|Baseline|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755699|NCT01580098|B1|Baseline|Control Group|treatment as usual
755700|NCT01580098|P3|Participant Flow|Nurse-monitoring for Patients With Diabetes Mellitus Type 2|"nurse-monitoring for patients with Diabetes Mellitus~Nurses are entering vital parameters of the patient with mobile devices"
755701|NCT01580098|P2|Participant Flow|Self-monitoring for Patients With Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital."
755702|NCT01580098|P1|Participant Flow|Control Group|treatment as usual
755703|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755704|NCT01580098|O1|Outcome|Control Group|treatment as usual
755847|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
755705|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755706|NCT01580098|O1|Outcome|Control Group|treatment as usual
755707|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755708|NCT01580098|O1|Outcome|Control Group|treatment as usual
755709|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755710|NCT01580098|O1|Outcome|Control Group|treatment as usual
755711|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755712|NCT01580098|O1|Outcome|Control Group|treatment as usual
755713|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755714|NCT01580098|O1|Outcome|Control Group|treatment as usual
756132|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
755715|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755716|NCT01580098|O1|Outcome|Control Group|treatment as usual
755717|NCT01580098|O2|Outcome|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters. Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755718|NCT01580098|O1|Outcome|Control Group|treatment as usual
755719|NCT01580098|E2|Reported Event|Self-monitoring and Nurse Monitoring Diabetes Mellitus Type 2|"Patients are self-monitoring and submitting their vital parameters.~Self-monitoring for patients with Diabetes mellitus type 2: Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.~Home nursing is also included. Nurses are measuring and entering the vital parameters of the patients.~Nurse-monitoring for patients with Diabetes mellitus type 2: Nurses are submitting the vital parameters of the patient via mobile device.~No patients using the mobile nursing finished the study, so in the final statistical analysis they were not analysed as separate arm.~Due to low enrollement in the Nurse Monitoring arm, it is combined in this module."
755720|NCT01580098|E1|Reported Event|Control Group|treatment as usual
755721|NCT01580072|B4|Baseline|Total|Total of all reporting groups
755722|NCT01580072|B3|Baseline|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755723|NCT01580072|B2|Baseline|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755724|NCT01580072|B1|Baseline|Control Group|Participants in the control group receive usual care.
755725|NCT01580072|P3|Participant Flow|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755726|NCT01580072|P2|Participant Flow|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755727|NCT01580072|P1|Participant Flow|Control Group|Participants in the control group receive usual care.
755728|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755729|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755730|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
755731|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755732|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755733|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
755734|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755735|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755736|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
755737|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755738|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755739|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
755740|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755741|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755742|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
755743|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755744|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755745|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
755746|NCT01580072|O3|Outcome|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755747|NCT01580072|O2|Outcome|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755748|NCT01580072|O1|Outcome|Control Group|Participants in the control group receive usual care.
756133|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
755749|NCT01580072|E3|Reported Event|Nurse Monitoring for Patients With COPD|nurse-monitoring for patients with severe COPD: Nurses are entering vital parameters of the patient with mobile devices.
755750|NCT01580072|E2|Reported Event|Self Monitoring for Patients With COPD|self-monitoring for patients with severe COPD: Intervention Group entering vital parameters via Web Portal or automatic call center.
755751|NCT01580072|E1|Reported Event|Control Group|Participants in the control group receive usual care.
755752|NCT01580020|B3|Baseline|Total|Total of all reporting groups
755753|NCT01580020|B2|Baseline|Dexamethasone|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755754|NCT01580020|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755755|NCT01580020|P4|Participant Flow|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755756|NCT01580020|P3|Participant Flow|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitrally
755757|NCT01580020|P2|Participant Flow|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755758|NCT01580020|P1|Participant Flow|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755759|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755760|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755761|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755762|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755763|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755764|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755765|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755766|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755767|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755768|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755769|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755770|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755771|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755772|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755773|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755774|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755775|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755776|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755777|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755778|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
758523|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
755779|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755780|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755781|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755782|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755783|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755784|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755785|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755786|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755787|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755788|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755789|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755790|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755848|NCT01579669|O1|Outcome|Primary Care Providers|Participants' primary care providers
755849|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
755791|NCT01580020|O4|Outcome|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755792|NCT01580020|O3|Outcome|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755793|NCT01580020|O2|Outcome|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required.
755794|NCT01580020|O1|Outcome|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755795|NCT01580020|E4|Reported Event|Dexamethasone (CRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755796|NCT01580020|E3|Reported Event|Ranibizumab (CRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755797|NCT01580020|E2|Reported Event|Dexamethasone (BRVO)|A PRN re-treatment scheme will be applied for the Dexamethasone arm during this extension study, i.e. patients may receive an implant at V1E or later as needed. Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) Minimum period of 5 months in between implantations was required
755798|NCT01580020|E1|Reported Event|Ranibizumab (BRVO)|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
755799|NCT01579916|B3|Baseline|TOTAL|Total of all reporting groups
755800|NCT01579916|B2|Baseline|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755801|NCT01579916|B1|Baseline|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755802|NCT01579916|P2|Participant Flow|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755803|NCT01579916|P1|Participant Flow|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755804|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755805|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
756134|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
755806|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755807|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755808|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755809|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755810|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755811|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755812|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755813|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755814|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755850|NCT01579669|E2|Reported Event|Primary Care Providers|Primary care providers of autistic adults participating in the study.
755815|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755816|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755817|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755818|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755819|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755820|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755821|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755822|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755823|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755824|NCT01579916|O2|Outcome|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755825|NCT01579916|O1|Outcome|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755826|NCT01579916|E2|Reported Event|Placebo|Placebo is supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
755911|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
756135|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
755827|NCT01579916|E1|Reported Event|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
755828|NCT01579747|B3|Baseline|Total|Total of all reporting groups
755829|NCT01579747|B2|Baseline|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
755830|NCT01579747|B1|Baseline|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
755831|NCT01579747|P2|Participant Flow|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
755832|NCT01579747|P1|Participant Flow|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
755833|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
755834|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
755835|NCT01579747|O2|Outcome|Ultrasound Guided Sciatic Nerve Block|Sciatic nerve block performed with ultrasound guidance
755836|NCT01579747|O1|Outcome|Nerve Stimulation Sciatic Nerve Block|Sciatic nerve block performed with nerve stimulation
755837|NCT01579747|E2|Reported Event|Ultrasound Guided Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach when using an ultrasound
755838|NCT01579747|E1|Reported Event|Nerve Stimulation Sciatic Nerve Block|Time taken to complete a sciatic nerve block via the lateral popliteal approach using nerve stimulation
755839|NCT01579669|B3|Baseline|Total|Total of all reporting groups
755840|NCT01579669|B2|Baseline|Primary Care Providers|Primary care providers taking care of autistic adults participating in this study
755841|NCT01579669|B1|Baseline|Autistic Adults|Adults on the autism spectrum
755842|NCT01579669|P2|Participant Flow|Primary Care Providers|Participants' primary care providers
755843|NCT01579669|P1|Participant Flow|Autistic Adults|Adults on the autism spectrum
755844|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
755845|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
755846|NCT01579669|O1|Outcome|Autistic Adults|Adults on the autism spectrum
755851|NCT01579669|E1|Reported Event|Autistic Adults|Adults on the autism spectrum
755852|NCT01579578|B3|Baseline|Total|Total of all reporting groups
755853|NCT01579578|B2|Baseline|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755854|NCT01579578|B1|Baseline|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755855|NCT01579578|P2|Participant Flow|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755856|NCT01579578|P1|Participant Flow|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755857|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755858|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755859|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755860|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755861|NCT01579578|O2|Outcome|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755862|NCT01579578|O1|Outcome|AZD8931 + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755863|NCT01579578|E2|Reported Event|Placebo + Paclitaxel|AZD8931 matching placebo bd administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755864|NCT01579578|E1|Reported Event|AZD8931 40mg + Paclitaxel|AZD8931 40 mg bd (Twice daily) administered orally in combination with paclitaxel 80 mg/m2 administered intravenously [approximately 1 hour duration] on D1, 8 and 15 of each 28 day treatment cycle
755865|NCT01579565|B3|Baseline|Total|Total of all reporting groups
755866|NCT01579565|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
756136|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
755867|NCT01579565|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755868|NCT01579565|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755869|NCT01579565|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available balanced saline solution (BSS) through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755870|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755871|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755991|NCT01579084|B10|Baseline|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
755872|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755873|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755874|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755875|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755876|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755877|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755912|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755913|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755878|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755879|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755880|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755881|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755882|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755992|NCT01579084|B9|Baseline|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
755883|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755884|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755885|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755886|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755887|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755888|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755889|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
758524|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
755890|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755891|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755892|NCT01579565|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755893|NCT01579565|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755923|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755924|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755894|NCT01579565|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755895|NCT01579565|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
755896|NCT01579474|B7|Baseline|Total|Total of all reporting groups
755897|NCT01579474|B6|Baseline|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755898|NCT01579474|B5|Baseline|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755899|NCT01579474|B4|Baseline|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755900|NCT01579474|B3|Baseline|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755901|NCT01579474|B2|Baseline|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755902|NCT01579474|B1|Baseline|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755903|NCT01579474|P6|Participant Flow|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755904|NCT01579474|P5|Participant Flow|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755905|NCT01579474|P4|Participant Flow|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755906|NCT01579474|P3|Participant Flow|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755907|NCT01579474|P2|Participant Flow|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755908|NCT01579474|P1|Participant Flow|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily (q.d.) for 12 or 24 weeks combined with pegylated interferon alfa-2b and ribavirin (PegIFNα-2b/RBV) for 24 weeks in treatment-naive patients.
755909|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755910|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755914|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755915|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755916|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755917|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755918|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755919|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755920|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755921|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755922|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755925|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755926|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755927|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755928|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755929|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755930|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755931|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755932|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755933|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755934|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755935|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755936|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755937|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755938|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755939|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755940|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755941|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755942|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
758525|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
755943|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755944|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755945|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755946|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755947|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755948|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755949|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755950|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755951|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755952|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755953|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755954|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755955|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755956|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755957|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755958|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755959|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755960|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755961|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755962|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755963|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755964|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755965|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
755966|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755967|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755968|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755969|NCT01579474|O6|Outcome|Breakthrough Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Breakthrough) patients.
755970|NCT01579474|O5|Outcome|Null Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (null responder) patients.
755971|NCT01579474|O4|Outcome|Partial Responder Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (Partial responder) patients.
756470|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
755972|NCT01579474|O3|Outcome|Relapser Patients - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined withPegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced (relapser) patients.
755973|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755974|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755975|NCT01579474|O3|Outcome|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFNα-2b/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
755976|NCT01579474|O2|Outcome|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755977|NCT01579474|O1|Outcome|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFNα-2b/RBV for 24 weeks in treatment-naive patients.
755978|NCT01579474|E3|Reported Event|Faldaprevir 240 mg q.d - Cohort II|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 24 weeks combined with PegIFN/RBV for 24 or 48 weeks in treatment-experienced Non-responder (null responder and partial responder), breakthrough and relapser patients.
755979|NCT01579474|E2|Reported Event|Faldaprevir 240 mg q.d - Cohort I|Faldaprevir (BI 201335) 240 mg soft gelatine capsule was given once daily for 12 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
755980|NCT01579474|E1|Reported Event|Faldaprevir 120 mg q.d - Cohort I|Faldaprevir (BI 201335) 120 mg soft gelatine capsule was given once daily for 12 or 24 weeks combined with PegIFN/RBV for 24 weeks in treatment-naive patients.
755981|NCT01579305|B3|Baseline|Total|Total of all reporting groups
755982|NCT01579305|B2|Baseline|Subjects Randomized to Receive Restylane-L®|
755983|NCT01579305|B1|Baseline|Subjects Randomized to Receive VOLBELLA®|
755984|NCT01579305|P2|Participant Flow|Subjects Randomized to Receive Restylane-L®|
755985|NCT01579305|P1|Participant Flow|Subject Randomized to Receive VOLBELLA®|
755986|NCT01579305|O2|Outcome|Subjects Randomized to Receive Restylane-L® and Treated|
755987|NCT01579305|O1|Outcome|Subjects Randomized to Receive VOLBELLA® and Treated|
755993|NCT01579084|B8|Baseline|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
755994|NCT01579084|B7|Baseline|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
755995|NCT01579084|B6|Baseline|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
755996|NCT01579084|B5|Baseline|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
755997|NCT01579084|B4|Baseline|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
755998|NCT01579084|B3|Baseline|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
755999|NCT01579084|B2|Baseline|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
756000|NCT01579084|B1|Baseline|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
756001|NCT01579084|P10|Participant Flow|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
756002|NCT01579084|P9|Participant Flow|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
756003|NCT01579084|P8|Participant Flow|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
756004|NCT01579084|P7|Participant Flow|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
756005|NCT01579084|P6|Participant Flow|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
756006|NCT01579084|P5|Participant Flow|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
756007|NCT01579084|P4|Participant Flow|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
756008|NCT01579084|P3|Participant Flow|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
756009|NCT01579084|P2|Participant Flow|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
756010|NCT01579084|P1|Participant Flow|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
756011|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
758526|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
756012|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
756013|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
756014|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
756015|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
756016|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
756017|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
756018|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
756019|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
756020|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
756021|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
756022|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
756023|NCT01579084|O4|Outcome|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to the face twice daily for 5 days. Includes participants treated with Vehicle in any of the randomized treatment groups.
756024|NCT01579084|O3|Outcome|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face twice daily for 5 days. Includes participants treated with Formulation C in any of the randomized treatment groups.
756025|NCT01579084|O2|Outcome|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face twice daily for 5 days. Includes participants treated with Formulation B in any of the randomized treatment groups.
756026|NCT01579084|O1|Outcome|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face twice daily for 5 days. Includes participants treated with Formulation A in any of the randomized treatment groups.
756027|NCT01579084|E10|Reported Event|AGN-199201 Vehicle|AGN-199201 Vehicle (Placebo) applied to both sides of the face twice daily for 5 days.
773227|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
756028|NCT01579084|E9|Reported Event|AGN-199201 Formulation C|AGN-199201 Formulation C applied to both sides of the face twice daily for 5 days.
756029|NCT01579084|E8|Reported Event|AGN-199201 Formulation B|AGN-199201 Formulation B applied to both sides of the face twice daily for 5 days.
756030|NCT01579084|E7|Reported Event|AGN-199201 Formulation A|AGN-199201 Formulation A applied to both sides of the face twice daily for 5 days.
756031|NCT01579084|E6|Reported Event|AGN-199201 Formulation C and Vehicle|AGN-199201 Formulation C applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
756032|NCT01579084|E5|Reported Event|AGN-199201 Formulation B and Vehicle|AGN-199201 Formulation B applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
756033|NCT01579084|E4|Reported Event|AGN-199201 Formulation A and Vehicle|AGN-199201 Formulation A applied to one side of the face and AGN-199201 Vehicle applied to the other side of the face twice daily for 5 days.
756034|NCT01579084|E3|Reported Event|AGN-199201 Formulation C and A|AGN-199201 Formulation C applied to one side of the face and Formulation A applied to the other side of the face twice daily for 5 days.
756035|NCT01579084|E2|Reported Event|AGN-199201 Formulation B and C|AGN-199201 Formulation B applied to one side of the face and Formulation C applied to the other side of the face twice daily for 5 days.
756036|NCT01579084|E1|Reported Event|AGN-199201 Formulation A and B|AGN-199201 Formulation A applied to one side of the face and Formulation B applied to the other side of the face twice daily for 5 days.
756037|NCT01579045|B1|Baseline|Overall Subjects|All subjects who were enrolled, and completed the study.
756038|NCT01579045|P1|Participant Flow|All Subjects|All subjects who were enrolled.
756039|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756040|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756041|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756042|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756092|NCT01579006|E1|Reported Event|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who had been receiving TCZ in the past and in whom the attending physician decided to start treatment with TCZ at the time of recruitment (according to the local label) were observed for 6 months.
756043|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756044|NCT01579045|O5|Outcome|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756045|NCT01579045|O4|Outcome|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756046|NCT01579045|O3|Outcome|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756047|NCT01579045|O2|Outcome|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756048|NCT01579045|O1|Outcome|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756049|NCT01579045|E5|Reported Event|Nelfilcon A (FDT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756050|NCT01579045|E4|Reported Event|Filcon II 3 (C1DT)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756155|NCT01578850|E1|Reported Event|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg with MTX (with or without other DMARDs).
756156|NCT01578785|B3|Baseline|Total|Total of all reporting groups
774950|NCT01492088|B4|Baseline|Total|Total of all reporting groups
756051|NCT01579045|E3|Reported Event|Etafilcon A (1DAMfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756052|NCT01579045|E2|Reported Event|Filcon II 3 (Sauflon)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756053|NCT01579045|E1|Reported Event|Senofilcon A (AOfA)|As this was a non-dispensing study, the study lenses were worn only during the duration of the visit. Study lenses were marked with a non-toxic marker (e.g. surgical pen) prior to use to aid identification of the lens orientation markers. Each subject wore sequentially the 5 study lenses in a bilateral and random fashion at two different visits.
756054|NCT01579006|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756055|NCT01579006|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA), according to the American College of Rheumatology (ACR) criteria and the Disease Activity Score Based on 28 Joints (DAS28), who have had an inadequate response (or were intolerant) to treatment with non-biological disease-modifying anti-rheumatic drugs (DMARDs) or with one biological agent in whom the attending physician decided to start treatment with tocilizumab (TCZ) (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756056|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756057|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756058|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756059|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756131|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756060|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756061|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756062|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756063|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756064|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756065|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756157|NCT01578785|B2|Baseline|GA 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
756158|NCT01578785|B1|Baseline|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
756066|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756067|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756068|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756069|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756070|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756071|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756072|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756073|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756074|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756075|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756076|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756077|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756078|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756079|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756080|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756081|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756082|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756083|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756084|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756085|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756086|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756087|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756088|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756089|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756090|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756091|NCT01579006|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe RA, according to the ACR criteria and the DAS28, who have had an inadequate response (or were intolerant) to treatment with non-biological DMARDs or with one biological agent in whom the attending physician decided to start treatment with TCZ (according to local label) at the time of recruitment or up to 8 week prior to the time of recruitment were observed for 6 months.
756093|NCT01578993|B1|Baseline|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
756094|NCT01578993|P1|Participant Flow|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
756095|NCT01578993|O1|Outcome|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
756096|NCT01578993|E1|Reported Event|Single Arm Study|Patients requiring a standard 5 Fr Dual Lumen Peripherally Inserted Central Catheter (PICC) for an anticipated minimum 14 Days of antibiotic, chemotherpay or nutritional support were eligible for enrollment into this observational study.
756097|NCT01578980|B1|Baseline|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
756098|NCT01578980|P1|Participant Flow|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
756099|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.~42 hours total: 14 hours in open-loop 28 hours in closed-loop"
756100|NCT01578980|O1|Outcome|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.~42 hours total: 14 hours in open-loop 28 hours in closed-loop"
778190|NCT01479543|B6|Baseline|Total|Total of all reporting groups
756101|NCT01578980|E1|Reported Event|Outpatient Control-to-Range|"Outpatient Control-to-Range: Testing system connectivity~Outpatient Control-to-Range: Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur."
756102|NCT01578850|B3|Baseline|Total|Total of all reporting groups
756103|NCT01578850|B2|Baseline|Placebo|Participants were randomized to receive PBO 50 mg QW with MTX (with or without other DMARDs).
756104|NCT01578850|B1|Baseline|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756105|NCT01578850|P3|Participant Flow|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756106|NCT01578850|P2|Participant Flow|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756107|NCT01578850|P1|Participant Flow|Open-Label Treatment|Participants in open-label treatment received Etanercept (ETN) 50 milligram (mg) once a week (QW) with MTX (with or without other DMARDs).
756108|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756109|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756110|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756111|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756112|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756113|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756114|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756115|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756116|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756117|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756118|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756119|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756120|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756121|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756122|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756123|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756124|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756125|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756126|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756127|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756128|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756129|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756130|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756137|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756138|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756139|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756140|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756141|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756142|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756143|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756144|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756145|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756146|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756147|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756148|NCT01578850|O1|Outcome|Open-Label Treatment|Participants in open-label treatment received ETN 50 mg QW with MTX (with or without other DMARDs).
756149|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756150|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756151|NCT01578850|O2|Outcome|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756152|NCT01578850|O1|Outcome|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
756153|NCT01578850|E3|Reported Event|Placebo|Participants were randomized to receive PBO 50 mg QW + MTX (with or without DMARDs).
756154|NCT01578850|E2|Reported Event|Etanercept|Participants were randomized to receive ETN 50 mg QW with MTX (with or without other DMARDs).
778447|NCT01478360|E2|Reported Event|Placebo|Placebo
756159|NCT01578785|P2|Participant Flow|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
756160|NCT01578785|P1|Participant Flow|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
756161|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
756162|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
756163|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
756164|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
756165|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
756166|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
756167|NCT01578785|O2|Outcome|GA 20 MG/0.5 ML|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
756168|NCT01578785|O1|Outcome|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
756169|NCT01578785|E2|Reported Event|Ga 20 mg/0.5 ml|Glatiramer acetate (GA) 20 mg/0.5 ml solution in prefilled syringe for subcutaneous injection once daily.
756170|NCT01578785|E1|Reported Event|Placebo|Placebo solution in prefilled syringe for subcutaneous injection once daily.
756171|NCT01578772|B1|Baseline|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
756172|NCT01578772|P1|Participant Flow|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
756173|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
756174|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
756175|NCT01578772|O2|Outcome|Week 6|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
756176|NCT01578772|O1|Outcome|Baseline (Week 0)|All participants received telmisartan 80mg tablets po daily for 6 weeks. Flow-mediated dilatation (FMD) testing was performed for all participants at baseline (week 0) and 6 weeks.
756177|NCT01578772|E1|Reported Event|Telmisartan|"Open label~Telmisartan: 80mg tablets po daily for 6 weeks"
756178|NCT01578707|B3|Baseline|Total|Total of all reporting groups
756179|NCT01578707|B2|Baseline|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
756180|NCT01578707|B1|Baseline|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
756181|NCT01578707|P2|Participant Flow|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
756260|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756182|NCT01578707|P1|Participant Flow|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
756183|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
756184|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
756185|NCT01578707|O2|Outcome|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
756186|NCT01578707|O1|Outcome|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
756187|NCT01578707|E2|Reported Event|Ibrutinib (Arm B)|"A Bruton Tyrosine Kinase Inhibitor~ibrutinib: ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity"
756188|NCT01578707|E1|Reported Event|Ofatumumab (Arm A)|"An anti-CD20 monoclonal antibody~ofatumumab: The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
756189|NCT01578330|B1|Baseline|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
756190|NCT01578330|P1|Participant Flow|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
756191|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
756192|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
756193|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
756194|NCT01578330|O1|Outcome|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
756195|NCT01578330|E1|Reported Event|Fingolimod, FTY720|Patients received fingolimod 0.5 mg oral capsules daily with or without food.
778448|NCT01478360|E1|Reported Event|AIN457 10 mg/kg|AIN457 10 mg/kg
756196|NCT01578187|B1|Baseline|Hair2Go Device|The subjects who participated in the label comprehension phase, of them most participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
756197|NCT01578187|P1|Participant Flow|Hair2Go Device|"This group included subjects who participated in the label comprehension phase. From these subjects, 48 subjects self-included in the usability phase (no contraindications) and chose to use the device for 1 treatment.~The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM) test."
756198|NCT01578187|O2|Outcome|Usability - Non Critical Error|Non critical error: An error that, if repeated without correction/intervention, may cause an adverse event.
756199|NCT01578187|O1|Outcome|Usability - Critical Error|Critical error: an error that may cause a serious adverse event or an adverse event from a single occurrence
756200|NCT01578187|O1|Outcome|Label Comprehension Group|Subjects that participated in the label comprehension phase of the study
756201|NCT01578187|E1|Reported Event|Hair2Go (Me) Device|The subjects who participated in the label comprehension phase; the majority of whom participated in the usability phase. The subjects included all skin types and a population of low health literacy subjects based on the Rapid Estimate of Adult Literacy in Medicine (REALM)test.
756202|NCT01578044|B3|Baseline|Total|Total of all reporting groups
756203|NCT01578044|B2|Baseline|Usual Care Group|"Usual care~Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
756204|NCT01578044|B1|Baseline|Intervention Group|"Patients who are randomized to the intervention group will receive the following:~Patient education: Patients will receive information on dabigatran, apixaban, and rivaroxaban, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacy follow-up: If the anticoagulant has not been refilled, the pharmacy staff will contact the patient to assess reasons the patient has not refilled the medication."
756205|NCT01578044|P2|Participant Flow|Usual Care|"Usual care patients will receive information on dabigatran, apixaban, and rivaroxaban including risks, benefits and potential side effects.~Following the end of the study, the usual care patients will receive the additional educational materials the intervention group received during the study."
756206|NCT01578044|P1|Participant Flow|Intervention Group|"Intervention patients will receive the following:~Patient education: All patients will receive information on their oral anticoagulant, including risks, benefits, and potential side effects. Intervention patients will receive additional materials at the beginning of the study through the mail.~Tele-monitoring: IVR technology will be used to send patients automated reminders to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each anticoagulant prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
756207|NCT01578044|O2|Outcome|Usual Care Group|All usual care patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Additionally, following their time in the study, the usual care patients will receive the additional educational materials the usual care received.
758527|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
756208|NCT01578044|O1|Outcome|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
756209|NCT01578044|E2|Reported Event|Usual Care Group|"Usual care~All patients will receive information on dabigatran, rivaroxaban, and apixaban, including risks, benefits, and potential side effects. Also, following their enrollment in the study will receive the additional educational materials given to the intervention group during their time in the study."
756210|NCT01578044|E1|Reported Event|Intervention Group|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescription.~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
756211|NCT01578031|B5|Baseline|Total|Total of all reporting groups
756212|NCT01578031|B4|Baseline|Non-obese Subjects Without OSA|"Control.~Usual Care: Usual care."
756213|NCT01578031|B3|Baseline|Obese Subjects Without OSA|"Control.~Usual Care: Usual care."
756214|NCT01578031|B2|Baseline|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756215|NCT01578031|B1|Baseline|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756216|NCT01578031|P4|Participant Flow|Non-obese Subjects Without OSA|"Control.~Usual Care: Usual care."
756217|NCT01578031|P3|Participant Flow|Obese Subjects Without OSA|"Control.~Usual Care: Usual care."
756218|NCT01578031|P2|Participant Flow|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756219|NCT01578031|P1|Participant Flow|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756220|NCT01578031|O2|Outcome|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756221|NCT01578031|O1|Outcome|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756222|NCT01578031|E4|Reported Event|Non-obese Patients Without Sleep Apnea|Control Non-obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
756223|NCT01578031|E3|Reported Event|Obese Patients Without Sleep Apnea|Control Obese adults between the 40 and 65 years of age without OSA as evidenced by an apnea/hypopnea index < 15
756224|NCT01578031|E2|Reported Event|Non-obese Patients With Obstructive Sleep Apnea|"Non-obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756225|NCT01578031|E1|Reported Event|Obese Patients With Obstructive Sleep Apnea|"Obese adults between the 40 and 65 years of age with a new diagnosis of OSA as evidenced by an apnea/hypopnea index ≥ 15, ≤ 75 episodes per hour, who are naïve to CPAP use will be started on CPAP treatment.~Positive Airway Pressure During Sleep (ResMed S9 Elite): Positive airway pressure during sleep (ResMed S9 Elite)."
756226|NCT01577966|B1|Baseline|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
756227|NCT01577966|P1|Participant Flow|Sulfasalazine|Sulfasalazine
756228|NCT01577966|O1|Outcome|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
756229|NCT01577966|E1|Reported Event|Sulfasalazine|"Sulfasalazine: Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
756230|NCT01577758|B1|Baseline|All Participants|All participants who participated in the Dose Escalation and mCRC Expansion Phases.
756231|NCT01577758|P8|Participant Flow|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
756232|NCT01577758|P7|Participant Flow|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756233|NCT01577758|P6|Participant Flow|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756234|NCT01577758|P5|Participant Flow|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756235|NCT01577758|P4|Participant Flow|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756236|NCT01577758|P3|Participant Flow|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756237|NCT01577758|P2|Participant Flow|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756238|NCT01577758|P1|Participant Flow|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756239|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756240|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756241|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756242|NCT01577758|O1|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756243|NCT01577758|O8|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
756244|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756245|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756246|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756247|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756248|NCT01577758|O3|Outcome|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756249|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756250|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756251|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
756252|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
756253|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
756254|NCT01577758|O2|Outcome|MLN0264 1.8 mg/kg (mCRC Expansion)|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in participants with metastatic colorectal (rectal, colon, or colorectal) cancer (mCRC).
756255|NCT01577758|O1|Outcome|MLN0264 Dose Escalation Phase|MLN0264 0.3 to 2.4 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year in the dose escalation phase.
756256|NCT01577758|O7|Outcome|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756257|NCT01577758|O6|Outcome|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756258|NCT01577758|O5|Outcome|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756259|NCT01577758|O4|Outcome|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756261|NCT01577758|O2|Outcome|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756262|NCT01577758|O1|Outcome|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756263|NCT01577758|E7|Reported Event|MLN0264 2.4 mg/kg|MLN0264 2.4 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756264|NCT01577758|E6|Reported Event|MLN0264 2.1 mg/kg|MLN0264 2.1 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756265|NCT01577758|E5|Reported Event|MLN0264 1.8 mg/kg|MLN0264 1.8 mg/kg, 30-minute IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756266|NCT01577758|E4|Reported Event|MLN0264 1.5 mg/kg|MLN0264 1.5 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756267|NCT01577758|E3|Reported Event|MLN0264 1.2 mg/kg|MLN0264 1.2 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756268|NCT01577758|E2|Reported Event|MLN0264 0.6 mg/kg|MLN0264 0.6 mg/kg, 30-minute intravenous IV infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756269|NCT01577758|E1|Reported Event|MLN0264 0.3 mg/kg|MLN0264 0.3 mg/kg, 30-minute intravenous (IV) infusion, Day 1 of each 21-day cycle, until disease progression or unacceptable toxicity or up to 1 year.
756270|NCT01577745|B7|Baseline|Total|Total of all reporting groups
756271|NCT01577745|B6|Baseline|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
756272|NCT01577745|B5|Baseline|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756273|NCT01577745|B4|Baseline|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756274|NCT01577745|B3|Baseline|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756275|NCT01577745|B2|Baseline|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756276|NCT01577745|B1|Baseline|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756762|NCT01576159|P4|Participant Flow|Control Group|Didn't participate any organized physical exercises
756277|NCT01577745|P6|Participant Flow|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
756278|NCT01577745|P5|Participant Flow|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756279|NCT01577745|P4|Participant Flow|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756280|NCT01577745|P3|Participant Flow|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756281|NCT01577745|P2|Participant Flow|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756282|NCT01577745|P1|Participant Flow|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute intravenous (IV) infusion on Day 1 of each 21-day cycle.
756283|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756284|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756285|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756286|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756287|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756288|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756289|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756290|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756291|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756292|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756293|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756294|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756295|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756296|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756297|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756298|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756299|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756300|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756301|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756302|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
758528|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
756303|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756304|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756305|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756306|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756307|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756308|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756309|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756310|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756311|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756312|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756313|NCT01577745|O6|Outcome|MMEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756314|NCT01577745|O5|Outcome|MMEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756315|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle..
756316|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756317|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756318|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756319|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756320|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
778510|NCT01478009|B3|Baseline|Total|Total of all reporting groups
756321|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756322|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756323|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756324|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756325|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756326|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756327|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756328|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756329|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756330|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756331|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756332|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756333|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756334|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756335|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756336|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756337|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756338|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756339|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756340|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756341|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756342|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756343|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756344|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756345|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756346|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756347|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756348|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756349|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756350|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756351|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756352|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756353|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756354|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756355|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756356|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756357|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756358|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756359|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756360|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756361|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756362|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756363|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756364|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756365|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
778511|NCT01478009|B2|Baseline|Placebo|
756366|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756367|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756368|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756369|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756370|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756371|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756372|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756373|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756374|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756375|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756376|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756377|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756378|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756379|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756380|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756381|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756382|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756383|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756384|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756385|NCT01577745|O6|Outcome|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
756386|NCT01577745|O5|Outcome|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756387|NCT01577745|O4|Outcome|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756388|NCT01577745|O3|Outcome|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756389|NCT01577745|O2|Outcome|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756390|NCT01577745|O1|Outcome|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756391|NCT01577745|O1|Outcome|MEDI0639|Participants received MEDI0639, in dose escalation phase starting from dose level 1 to 6 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756392|NCT01577745|E6|Reported Event|MEDI0639 Cohort 6|Participants received MEDI0639 dose level 6 as a 60-minute IV infusion on Day 1 of each 21 day cycle.
756393|NCT01577745|E5|Reported Event|MEDI0639 Cohort 5|Participants received MEDI0639 dose level 5 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756394|NCT01577745|E4|Reported Event|MEDI0639 Cohort 4|Participants received MEDI0639 dose level 4 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756395|NCT01577745|E3|Reported Event|MEDI0639 Cohort 3|Participants received MEDI0639 dose level 3 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756396|NCT01577745|E2|Reported Event|MEDI0639 Cohort 2|Participants received MEDI0639 dose level 2 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756397|NCT01577745|E1|Reported Event|MEDI0639 Cohort 1|Participants received MEDI0639 dose level 1 as a 60-minute IV infusion on Day 1 of each 21-day cycle.
756398|NCT01577732|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
756399|NCT01577732|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
756400|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
756401|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
756402|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
756403|NCT01577732|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
756404|NCT01577732|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including 12 and 24 months received a single dose of Infanrix-IPV+Hib™. The vaccine was administered intramuscularly in the anterolateral side of the thigh.
756405|NCT01577706|B1|Baseline|All Study Participants|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756406|NCT01577706|P3|Participant Flow|Placebo, Dextroamphetamine, Alprazolam Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
756407|NCT01577706|P2|Participant Flow|Alprazolam, Dextroamphetamine, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
756408|NCT01577706|P1|Participant Flow|Dextroamphetamine, Alprazolam, Placebo Sequence|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day~Placebo: single-dose, 1-day"
756409|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756410|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756411|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
756412|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756413|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756414|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
756415|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756416|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756417|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
756418|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756419|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756420|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
756421|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756422|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756423|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
756424|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756425|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756426|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
756427|NCT01577706|O3|Outcome|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
758529|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
756428|NCT01577706|O2|Outcome|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756429|NCT01577706|O1|Outcome|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo: single-dose, 1-day"
756430|NCT01577706|E3|Reported Event|Placebo|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Placebo, single-dose, 1-day"
756431|NCT01577706|E2|Reported Event|Dextroamphetamine|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Dextroamphetamine: Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day"
756432|NCT01577706|E1|Reported Event|Alprazolam|"Healthy male volunteers receiving drug and undergoing 1H-MRSI scanning~Alprazolam: Alprazolam, gel-capsule, 1mg, single-dose, 1-day"
756433|NCT01577628|B3|Baseline|Total|Total of all reporting groups
756434|NCT01577628|B2|Baseline|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756435|NCT01577628|B1|Baseline|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756436|NCT01577628|P3|Participant Flow|Screen Only|Subject was not randomized to either treatment prior to study termination.
756437|NCT01577628|P2|Participant Flow|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756438|NCT01577628|P1|Participant Flow|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756439|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756440|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756441|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756442|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756443|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756527|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756444|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756445|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756446|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756447|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756448|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756449|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756450|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756451|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756452|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756453|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756454|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756455|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756456|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756457|NCT01577628|O2|Outcome|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756458|NCT01577628|O1|Outcome|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756459|NCT01577628|E2|Reported Event|Group 2: No Intervention Control Group|Subjects may use a moisturizer if they wish to but no instruction or product is provided
756460|NCT01577628|E1|Reported Event|Group 1: Lipikar Balm AP|"Daily application of Lipikar Balm AP starting at birth~Lipikar Balm AP: Daily application of Lipikar Balm AP starting at birth"
756461|NCT01577381|B5|Baseline|Total|Total of all reporting groups
756462|NCT01577381|B4|Baseline|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756463|NCT01577381|B3|Baseline|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756464|NCT01577381|B2|Baseline|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756465|NCT01577381|B1|Baseline|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756466|NCT01577381|P4|Participant Flow|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756467|NCT01577381|P3|Participant Flow|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756468|NCT01577381|P2|Participant Flow|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756469|NCT01577381|P1|Participant Flow|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756471|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756472|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756473|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756474|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756475|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756476|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756477|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756478|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756479|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756480|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756481|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756482|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756483|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756484|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756485|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
778512|NCT01478009|B1|Baseline|KRG Extract|
756486|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756487|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756488|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756489|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756490|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756491|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756492|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756493|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756494|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756495|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756496|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756497|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756498|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756499|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756500|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756501|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756502|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756503|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756504|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756505|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756506|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756507|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756508|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756509|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756510|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756511|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756512|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756513|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756514|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756515|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756516|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756517|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756518|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756519|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756520|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756521|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756522|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756523|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756524|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756525|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756526|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756528|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756529|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756530|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756531|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756532|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756533|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756534|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756535|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756536|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756537|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756538|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756539|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756540|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756541|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756542|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756543|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756544|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756545|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756546|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756547|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756548|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756549|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756550|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756551|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756552|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
758530|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
756553|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756554|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756555|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756556|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756557|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756558|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756559|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756560|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756561|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756562|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756563|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756564|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756565|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756566|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756567|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756568|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756569|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756570|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756571|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756572|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756573|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756574|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756575|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756576|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756577|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756578|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756579|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756580|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756581|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756582|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756583|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756584|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756585|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756586|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756587|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756588|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756589|NCT01577381|O4|Outcome|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756590|NCT01577381|O3|Outcome|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756591|NCT01577381|O2|Outcome|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756592|NCT01577381|O1|Outcome|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756593|NCT01577381|E4|Reported Event|Placebo|Placebo was administered as an IV infusion over at least 30 minutes every 28 days for 11 doses.
756594|NCT01577381|E3|Reported Event|PF-04382923 15.0 mg/kg|PF-04382923 at 15.0 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756595|NCT01577381|E2|Reported Event|PF-04382923 7.5 mg/kg|PF-04382923 at 7.5 mg/kg was administered as an IV infusion over 30 minutes every 28 days for 11 doses.
756596|NCT01577381|E1|Reported Event|PF-04382923 2.5 mg/kg|PF-04382923 (RN6G) at 2.5 milligrams per kilogram (mg/kg) was administered as an intravenous (IV) infusion over 30 minutes every 28 days for 11 doses.
756597|NCT01577186|B1|Baseline|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
756598|NCT01577186|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
756599|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
756600|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
756601|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
756602|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
756603|NCT01577186|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12.as per Investigator’s discretion.
756604|NCT01577186|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day orally once daily up to Week 12 as per Investigator’s discretion.
756605|NCT01577160|B1|Baseline|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
756606|NCT01577160|P1|Participant Flow|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s Clinical Global Impression - Improvement (CGI-I) score.
756607|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
756608|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
756609|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
756610|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
756611|NCT01577160|O1|Outcome|Paliperidone Extended Release (ER)|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
756612|NCT01577160|E1|Reported Event|Paliperidone ER|Participants received paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment was done at Week 2, 4 and 8 as per Investigator’s discretion based upon participant’s CGI-I score.
756613|NCT01577108|B3|Baseline|Total|Total of all reporting groups
756614|NCT01577108|B2|Baseline|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
756615|NCT01577108|B1|Baseline|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
756616|NCT01577108|P2|Participant Flow|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
756617|NCT01577108|P1|Participant Flow|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
756618|NCT01577108|O2|Outcome|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days~Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 9 in the probiotic group (18.0%)."
756619|NCT01577108|O1|Outcome|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days~Number of GBS-Positive pregnant women who became GBS-Negative at childbirth is 21 in the probiotic group (42.9%)."
756620|NCT01577108|E2|Reported Event|Non-probiotics, GBS Test|"Treated with 2 placebo capsules once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
756621|NCT01577108|E1|Reported Event|Probiotics, GBS Test|"Treated with 2 oral probiotics once daily before sleeping for 14 days~GR-1, RC-14: oral taking 2 capsules before sleeping per day for 14 days"
756622|NCT01576952|B3|Baseline|Total|Total of all reporting groups
756623|NCT01576952|B2|Baseline|Vehicle|DuraSite vehicle dosed BID
756624|NCT01576952|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite dosed BID
756625|NCT01576952|P2|Participant Flow|Vehicle|DuraSite vehicle dosed BID
756626|NCT01576952|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite dosed BID
756627|NCT01576952|O2|Outcome|Vehicle|DuraSite vehicle dosed BID
756628|NCT01576952|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite dosed BID
756629|NCT01576952|E2|Reported Event|Vehicle|DuraSite vehicle dosed BID
756630|NCT01576952|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite dosed BID
758531|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
756631|NCT01576939|B1|Baseline|Intensity Modulated RT Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756632|NCT01576939|P1|Participant Flow|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756633|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756634|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756635|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756636|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756637|NCT01576939|O1|Outcome|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756638|NCT01576939|E1|Reported Event|Intensity Modulated Radiotherapy Treatment|"Radiation dose to the tumor is > 60 Gy at 1.8-2.2 Gy/fx.~intensity modulated radiotherapy treatment"
756639|NCT01576809|B1|Baseline|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
756640|NCT01576809|P1|Participant Flow|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
756641|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
756642|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
756761|NCT01576159|B1|Baseline|High-Impact Loading|Performed high-impact running exercise during intervention period.
756643|NCT01576809|O1|Outcome|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
756644|NCT01576809|E1|Reported Event|Upper Respiratory Tract Infection|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin : Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
756645|NCT01576718|B7|Baseline|Total|Total of all reporting groups
756646|NCT01576718|B6|Baseline|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756647|NCT01576718|B5|Baseline|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756648|NCT01576718|B4|Baseline|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756649|NCT01576718|B3|Baseline|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756650|NCT01576718|B2|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756651|NCT01576718|B1|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756652|NCT01576718|P7|Participant Flow|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756653|NCT01576718|P6|Participant Flow|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756702|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756654|NCT01576718|P5|Participant Flow|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756655|NCT01576718|P4|Participant Flow|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756656|NCT01576718|P3|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756657|NCT01576718|P2|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756658|NCT01576718|P1|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
756659|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756660|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756661|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756662|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756663|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756664|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756665|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756666|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756667|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756668|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756669|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756808|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
756809|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
756670|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756671|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756672|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756673|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756674|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756756|NCT01576367|E1|Reported Event|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756675|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756676|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756677|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756678|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756679|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756680|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756681|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756682|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756683|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756684|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756685|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
758532|NCT01568073|O5|Outcome|OPC 50mg|OPC, Opicapone 50mg
756686|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756687|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756688|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756689|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756690|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756691|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756692|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756693|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756694|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756695|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756696|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756697|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756698|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756699|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756700|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756701|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756703|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756704|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756705|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756706|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756757|NCT01576159|B5|Baseline|Total|Total of all reporting groups
756758|NCT01576159|B4|Baseline|Control Group|Didn't participate any organized physical exercises
756759|NCT01576159|B3|Baseline|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
779551|NCT01474863|B4|Baseline|Total|Total of all reporting groups
756707|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756708|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756709|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756710|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756711|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756712|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756713|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756714|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756715|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756716|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756717|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756718|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756719|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756720|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756721|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756722|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
786874|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
756723|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756724|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756725|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756726|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756727|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756728|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756729|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756730|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756731|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756732|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756733|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756734|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
758533|NCT01568073|O4|Outcome|OPC 25mg|OPC, Opicapone 25mg
756735|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756736|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756737|NCT01576718|O6|Outcome|Flovent Diskus 250mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756738|NCT01576718|O5|Outcome|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756739|NCT01576718|O4|Outcome|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756740|NCT01576718|O3|Outcome|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756741|NCT01576718|O2|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756742|NCT01576718|O1|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756743|NCT01576718|E6|Reported Event|Placebo MDPI|"Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756744|NCT01576718|E5|Reported Event|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756745|NCT01576718|E4|Reported Event|Fp MDPI 400 mcg|"Fluticasone propionate (Fp) 400 mcg per dose twice a day (for a total daily dose of 800 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756746|NCT01576718|E3|Reported Event|Fp MDPI 200 mcg|"Fluticasone propionate (Fp) 200 mcg per dose twice a day (for a total daily dose of 400 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756747|NCT01576718|E2|Reported Event|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756748|NCT01576718|E1|Reported Event|Flovent Diskus 250 mcg|"Fluticasone propionate (Fp) 250 mcg per dose twice a day (for a total daily dose of 500 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
756749|NCT01576367|B1|Baseline|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756750|NCT01576367|P1|Participant Flow|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756810|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
756811|NCT01576055|E2|Reported Event|BARD LifeStent|BARD LifeStent: Implant
756751|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756752|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756753|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756754|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756755|NCT01576367|O1|Outcome|Canakinumab|Patients will receive a standard dose at an equivalent of 2 mg/kg s.c. of canakinumab (ACZ885) every 8 weeks. Possible dose and/or dosing regimen adjustments that can be administered include: 4 mg/kg s.c. (every 4 to 8 weeks) 6 mg/kg s.c. (every 4 to 8 weeks) 8 mg/kg s.c. (every 4 to 8 weeks)
756760|NCT01576159|B2|Baseline|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
756763|NCT01576159|P3|Participant Flow|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
756764|NCT01576159|P2|Participant Flow|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
756765|NCT01576159|P1|Participant Flow|High-Impact Loading|Performed high-impact running exercise during intervention period.
756766|NCT01576159|O4|Outcome|Control Group|Not Participated any organized physical exercise
756767|NCT01576159|O3|Outcome|Non-Impact Loading|Performed Non-impact swimming exercise for 12 weeks
756768|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise for 12 weeks
756769|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise for 12 weeks
756770|NCT01576159|O4|Outcome|Control Group|Not participated any organized physical exercise
756771|NCT01576159|O3|Outcome|Non-Impact Loading|Performed non-impact swimming exercise during intervention period.
756772|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed Moderate-impact cycling exercise during intervention period.
756773|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
756774|NCT01576159|O4|Outcome|Control Group|Didn't participate any organized physical exercises
756775|NCT01576159|O3|Outcome|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
756776|NCT01576159|O2|Outcome|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
756777|NCT01576159|O1|Outcome|High-Impact Loading|Performed high-impact running exercise during intervention period.
756778|NCT01576159|E4|Reported Event|Control Group|Didn't participate any organized physical exercises
756779|NCT01576159|E3|Reported Event|Non-Impact Loading|Performed low-impact swimming exercise during intervention period.
756780|NCT01576159|E2|Reported Event|Moderate-Impact Loading|Performed moderate-impact cycling exercise during intervention period.
756781|NCT01576159|E1|Reported Event|High-Impact Loading|Performed high-impact running exercise during intervention period.
756782|NCT01576146|B1|Baseline|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
756783|NCT01576146|P1|Participant Flow|Etelcalcetide|Participants received a bolus intravenous (IV) injection of etelcalcetide 3 times a week (TIW) at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
756784|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
756785|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
756812|NCT01576055|E1|Reported Event|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
756813|NCT01576042|B3|Baseline|Total|Total of all reporting groups
756845|NCT01575912|O1|Outcome|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
756786|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
756787|NCT01576146|O1|Outcome|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
756788|NCT01576146|E1|Reported Event|Etelcalcetide|Participants received a bolus IV injection of etelcalcetide 3 times a week at the end of each hemodialysis session for up to 144 weeks in the extension study. The starting dose was the same as the final dose administered in the parent study (20120331); the dose was adjusted per protocol-specified guidelines to achieve or maintain parathyroid hormone values in the 150 to 300 pg/mL range.
756789|NCT01576120|B3|Baseline|Total|Total of all reporting groups
756790|NCT01576120|B2|Baseline|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
756791|NCT01576120|B1|Baseline|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
756859|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
756792|NCT01576120|P2|Participant Flow|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
756793|NCT01576120|P1|Participant Flow|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
756794|NCT01576120|O2|Outcome|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
756795|NCT01576120|O1|Outcome|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
756796|NCT01576120|E2|Reported Event|Bowel Prep Regimen First Boost 3 oz. and Second Boost 6 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 3 oz. and second boost 6 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
756797|NCT01576120|E1|Reported Event|Bowel Prep Regimen First Boost 6 oz. and Second Boost 3 oz.|"4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI~bowel prep regimen first boost 6 oz. and second boost 3 oz.: Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
756798|NCT01576055|B3|Baseline|Total|Total of all reporting groups
756799|NCT01576055|B2|Baseline|BARD LifeStent|BARD LifeStent: Implant
756800|NCT01576055|B1|Baseline|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
756801|NCT01576055|P2|Participant Flow|BARD LifeStent|BARD LifeStent: Implant
756802|NCT01576055|P1|Participant Flow|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
756803|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
756804|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
756805|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
756806|NCT01576055|O1|Outcome|TIGRIS Vascular Stent|TIGRIS Vascular Stent: Implant
756807|NCT01576055|O2|Outcome|BARD LifeStent|BARD LifeStent: Implant
756814|NCT01576042|B2|Baseline|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756815|NCT01576042|B1|Baseline|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756816|NCT01576042|P2|Participant Flow|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756817|NCT01576042|P1|Participant Flow|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756860|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
786876|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
756818|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756819|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756820|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756821|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756822|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756823|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756824|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756825|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756844|NCT01575912|O2|Outcome|Group of Subjects With Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
756826|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756827|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756828|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756829|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756830|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756831|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756832|NCT01576042|O2|Outcome|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756833|NCT01576042|O1|Outcome|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756834|NCT01576042|E2|Reported Event|Antiarrhythmic Medication|"The choice of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death~amiodarone: The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.~sotalol: The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death."
756835|NCT01576042|E1|Reported Event|Catheter Ablation|"The only ablation catheter that will be allowed in this study will be the Biosense Webster’s NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults~Biosense Webster's NAVI-STAR Thermo-Cool: The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults."
756836|NCT01575912|B4|Baseline|Total|Total of all reporting groups
756837|NCT01575912|B3|Baseline|Group of Controls Without Psychiatric Disorder|subjects without any psychiatric disorder and submitted to experimental pain tests
756838|NCT01575912|B2|Baseline|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
756839|NCT01575912|B1|Baseline|Group of Subjects With Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
756840|NCT01575912|P3|Participant Flow|Group of Subjects Without Psychiatric Troubles C|subjects without any psychiatric disorder and submitted to experimental pain tests
756841|NCT01575912|P2|Participant Flow|Group of Subjects Presenting Major Depression MD|subjects presenting a major depression according to the DSM-IV-TR and submitted to experimental pain tests
756842|NCT01575912|P1|Participant Flow|Group of Subjects Presenting Schizophrenia SC|subjects presenting a schizophrenia according to the DSM-IV-TR and submitted to experimental pain tests
756843|NCT01575912|O3|Outcome|Group of Subjects Without Psychiatric Troubles C|control subjects without any psychiatric disorder
756846|NCT01575912|E3|Reported Event|Group of Controls Without Psychiatric Disorder|control subjects without any psychiatric disorder and submitted to experimental pain tests
756847|NCT01575912|E2|Reported Event|Group of Subjects Presenting Major Depression MD|subjects presenting a diagnosis of major depression according to the DSM IV TR and submitted to experimental pain tests
756848|NCT01575912|E1|Reported Event|Group of Subjects With Schizophrenia SC|subjects presenting a diagnosis of schizophrenia according to the DSM IV TR and submitted to experimental pain tests
756849|NCT01575899|B4|Baseline|Total|Total of all reporting groups
756850|NCT01575899|B3|Baseline|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
756851|NCT01575899|B2|Baseline|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
756852|NCT01575899|B1|Baseline|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
756853|NCT01575899|P3|Participant Flow|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
756854|NCT01575899|P2|Participant Flow|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
756855|NCT01575899|P1|Participant Flow|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
756856|NCT01575899|O2|Outcome|Clarithromycin-Amoxicillin|Participants who are living in rural area and received 7-day clarithromycin, amoxicillin and rabeprazole for Hp eradication.
756857|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav.|Participants who are living in rural area and received 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for Hp eradication.
756858|NCT01575899|O1|Outcome|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin.
756861|NCT01575899|E3|Reported Event|Levofloxacin-Amox/Clav. (Re-eradication)|7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for re-eradication of patient still with evidence of Hp infection after previous intent of eradication.
756862|NCT01575899|E2|Reported Event|Clarithromycin-Amoxicillin|7-day clarithromycin, amoxicillin, rabeprazole for Hp eradication.
756863|NCT01575899|E1|Reported Event|Levofloxacin-Amox/Clav.|7-day levofloxacin, amoxicillin/clavulanate, rabeprazole for Hp eradication.
756864|NCT01575769|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756865|NCT01575769|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) via intravenous (IV) infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756866|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756867|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756868|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756869|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756870|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756871|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756872|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756873|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756874|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756875|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756876|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756877|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756878|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756879|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756880|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756881|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756882|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756883|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756884|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756885|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756886|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
756887|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
756888|NCT01575769|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion,once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available, whichever occurred first.
756889|NCT01575769|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for up to 104 weeks or until tocilizumab became commercially available whichever, occurred first.
756890|NCT01575756|B1|Baseline|Octafibrin Followed by Haemocomplettan® P or RiaSTAPTM or Haem|Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later or Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.
756891|NCT01575756|P2|Participant Flow|Haemocomplettan® P or RiaSTAPTM Followed by Octafibrin|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once followed by Octafibrin 70 mg/kg intravenously once 45 days later.
756892|NCT01575756|P1|Participant Flow|Octafibrin Followed by Haemocomplettan® P or RiaSTAPTM|Participants received Octafibrin 70 mg/kg intravenously once followed by Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once 45 days later.
756893|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
756894|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
756895|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
756896|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
756897|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
756898|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
756899|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
756900|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
756901|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
756902|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
756903|NCT01575756|O2|Outcome|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
756904|NCT01575756|O1|Outcome|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
756905|NCT01575756|E2|Reported Event|Haemocomplettan® P or RiaSTAPTM|Participants received Haemocomplettan® P or RiaSTAPTM 70 mg/kg intravenously once.
756906|NCT01575756|E1|Reported Event|Octafibrin|Participants received Octafibrin 70 mg/kg intravenously once.
756907|NCT01575561|B1|Baseline|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756908|NCT01575561|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756909|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756910|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756911|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756912|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756913|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756914|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756915|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756916|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756917|NCT01575561|O1|Outcome|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756918|NCT01575561|E1|Reported Event|Lurasidone|"Lurasidone 20, 40, 60,80 mg flexible dose~Lurasidone: Lurasidone 20-80 mg taken orally once daily"
756919|NCT01575522|B1|Baseline|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
756951|NCT01575080|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
756952|NCT01575054|B3|Baseline|Total|Total of all reporting groups
757100|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: up to 40 mg capsule daily"
756920|NCT01575522|P1|Participant Flow|Treatment (Tivantinib)|"Patients receive tivantinib 360 mg PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
756921|NCT01575522|O1|Outcome|Evaluation of c-Met Positive Circulating Tumor Cells|
756922|NCT01575522|O1|Outcome|Evaluation of Phospho c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
756923|NCT01575522|O1|Outcome|Evaluation of c-Met Positivity|MET amplification was defined as a MET/CEP7 ratio ≥ 2. Samples having a MET/CEP7 ratio from 1.5 and up to 2 were defined as having relative MET gain. Samples with a MET/CEP7 ratio of 1 but with more than two copies of each probe were defined as having polysomy of chromosome 7.
756924|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
756925|NCT01575522|O1|Outcome|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
756926|NCT01575522|E1|Reported Event|Treatment (Tivantinib)|"Patients receive tivantinib PO BID on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection at baseline and periodically during study for c-Met expression, relevant markers (HGF and VEGF), PTEN loss, and PI3K mutation analysis by FISH and IHC. Archived tumor tissue samples are also analyzed.~Laboratory Biomarker Analysis: Correlative studies~Tivantinib: Given PO"
756928|NCT01575197|B3|Baseline|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
756929|NCT01575197|B2|Baseline|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
756930|NCT01575197|B1|Baseline|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
756931|NCT01575197|P3|Participant Flow|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6, 10, & 14 weeks of age.
756932|NCT01575197|P2|Participant Flow|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 10 & 14 weeks of age.
756933|NCT01575197|P1|Participant Flow|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine (HRV) was administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age.
756934|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
756935|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
756936|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
756937|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
756938|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
756939|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
756940|NCT01575197|O2|Outcome|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
756941|NCT01575197|O1|Outcome|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
756942|NCT01575197|E3|Reported Event|Rotavirus Vaccine at Age 6,10,&14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6, 10, & 14 weeks of age.
756943|NCT01575197|E2|Reported Event|Rotavirus Vaccine at Age 10 & 14 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 10 & 14 weeks of age.
756944|NCT01575197|E1|Reported Event|Rotavirus Vaccine at Age 6 & 10 Weeks|Human rotavirus vaccine was administered concomitantly with other routine EPI vaccinations at 6 & 10 weeks of age.
756945|NCT01575080|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
756946|NCT01575080|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
756947|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
756948|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
756949|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
756950|NCT01575080|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use Contour TS Blood Glucose Monitoring System.
758534|NCT01568073|O3|Outcome|OPC 5mg|OPC, Opicapone 5mg
756953|NCT01575054|B2|Baseline|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756954|NCT01575054|B1|Baseline|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756955|NCT01575054|P2|Participant Flow|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756956|NCT01575054|P1|Participant Flow|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756957|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756977|NCT01575028|E1|Reported Event|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
756978|NCT01574703|B5|Baseline|Total|Total of all reporting groups
756958|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756959|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756960|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756961|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756962|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756963|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756964|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756965|NCT01575054|O2|Outcome|Normal Saline (Placebo) Followed by Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756966|NCT01575054|O1|Outcome|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
756967|NCT01575054|E2|Reported Event|Normal Saline (Placebo)|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
757089|NCT01574248|E2|Reported Event|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
758535|NCT01568073|O2|Outcome|Entacapone|Entacapone - 200 mg
756968|NCT01575054|E1|Reported Event|Botulinum Toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles.
756969|NCT01575028|B3|Baseline|Total|Total of all reporting groups
756970|NCT01575028|B2|Baseline|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
756971|NCT01575028|B1|Baseline|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
756972|NCT01575028|P2|Participant Flow|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
756973|NCT01575028|P1|Participant Flow|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
756974|NCT01575028|O2|Outcome|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
756975|NCT01575028|O1|Outcome|Local Anesthetic Infiltration Injection|"Patients will receive local anesthetic infiltration injected at the surgical site by the surgeon at the end of surgery.~Bupivacaine: The local anesthetic at the incision sites will be injected by the surgeon."
756976|NCT01575028|E2|Reported Event|Transversus Abdominis Plane (TAP) Block|"Patients will receive a transversus abdominis plane (TAP) block.~Ropivacaine: The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally"
757389|NCT01572792|E3|Reported Event|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
756979|NCT01574703|B4|Baseline|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
756980|NCT01574703|B3|Baseline|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
756981|NCT01574703|B2|Baseline|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
756982|NCT01574703|B1|Baseline|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
756983|NCT01574703|P4|Participant Flow|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
756984|NCT01574703|P3|Participant Flow|Nicotine Replacement Therapy (NRT) Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
756985|NCT01574703|P2|Participant Flow|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
756986|NCT01574703|P1|Participant Flow|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
756987|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
756988|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
756989|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
756990|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
756991|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757090|NCT01574248|E1|Reported Event|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
756992|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
756993|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
756994|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
756995|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
756996|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
756997|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
756998|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757046|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
756999|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757000|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
757001|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
757002|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757003|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757004|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
757005|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
757006|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757007|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757008|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
757009|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
757010|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757011|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757012|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
757091|NCT01574183|B3|Baseline|Total|Total of all reporting groups
758536|NCT01568073|O1|Outcome|Placebo|Placebo 200 mg
757013|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
757014|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757015|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757016|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
757017|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
757018|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757019|NCT01574703|O4|Outcome|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757020|NCT01574703|O3|Outcome|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
757021|NCT01574703|O2|Outcome|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
757022|NCT01574703|O1|Outcome|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757023|NCT01574703|E4|Reported Event|Placebo|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received placebo in a triple-dummy design were analyzed as part of this study.
757024|NCT01574703|E3|Reported Event|NRT Patch|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received NRT patch in a triple-dummy design were analyzed as part of this study.
757025|NCT01574703|E2|Reported Event|Bupropion|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received bupropion in a triple-dummy design were analyzed as part of this study.
757026|NCT01574703|E1|Reported Event|Varenicline|This was the non-treatment extension study of parent study NCT01456936. No study drug was provided during this extension phase. However, Cardiovascular events that occurred during parent study NCT01456936 when participants received varenicline in a triple-dummy design were analyzed as part of this study.
757027|NCT01574651|B3|Baseline|Total|Total of all reporting groups
757028|NCT01574651|B2|Baseline|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757029|NCT01574651|B1|Baseline|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757030|NCT01574651|P2|Participant Flow|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757031|NCT01574651|P1|Participant Flow|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757032|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757033|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757034|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757035|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757036|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757092|NCT01574183|B2|Baseline|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
758537|NCT01568073|E5|Reported Event|OPC 50mg|OPC, Opicapone 50mg
757037|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757038|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757039|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757040|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757041|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757042|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757043|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757044|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757045|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
758088|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
757047|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757048|NCT01574651|O2|Outcome|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757049|NCT01574651|O1|Outcome|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757050|NCT01574651|E2|Reported Event|Tiotropium Plus Formoterol and Placebo to QVA149|Tiotropium 18µg, once daily for inhalation use plus Formoterol 12µg, twice daily for inhalation use and placebo to QVA149, once daily for inhalation use.
757051|NCT01574651|E1|Reported Event|QVA149 Plus Placebo to Tiotropium and Placebo to Formoterol|QVA149 110/50µg, once daily for inhalation use plus placebo to tiotropium, once daily for inhalation use and placebo to formoterol, twice daily for inhalation use.
757052|NCT01574612|B1|Baseline|Topical Cream|xerese topical cream is the only active used in this trial
757053|NCT01574612|P1|Participant Flow|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
757054|NCT01574612|O1|Outcome|Topical Cream|commercial cream used
757055|NCT01574612|E1|Reported Event|Topical Cream|"commercial product being used~acyclovir/hydrocortisone cream: cream applied topically to lesion five times daily for five days"
757056|NCT01574326|B3|Baseline|Total|Total of all reporting groups
757057|NCT01574326|B2|Baseline|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
757058|NCT01574326|B1|Baseline|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate TID for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 POS and 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant's preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator's opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
757093|NCT01574183|B1|Baseline|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
757094|NCT01574183|P2|Participant Flow|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
757095|NCT01574183|P1|Participant Flow|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
757096|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
757097|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
757098|NCT01574183|O2|Outcome|Placebo|"Flexible dose up to 40 mg capsule daily~Placebo: 40 mg capsule daily"
757099|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: 40 mg capsule daily"
758538|NCT01568073|E4|Reported Event|OPC 25mg|OPC, Opicapone 25mg
757059|NCT01574326|P2|Participant Flow|FDP-Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on screening BSA category) for 2 weeks in FDP and then continued to receive sevelamer carbonate in DTP. Sevelamer carbonate for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as POS or 1.6 g TID for BSA ≥1.2 m^2 either as POS or tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as dose prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: by 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to <1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meal/snacks).
757060|NCT01574326|P1|Participant Flow|FDP-Placebo for Sevelamer Carbonate, DTP-Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for 2 weeks in FDP and sevelamer carbonate for 26 weeks in DTP. Placebo matched to sevelamer carbonate 3 times a day (TID) for 2 weeks in FDP: 0.4 g TID for BSA <0.75 m^2 or 0.8 g TID for BSA ≥0.75 to < 1.2 m^2 as powder for oral suspension (POS) & 1.6 g TID for BSA ≥1.2 m^2 as POS/tablets as per participant’s preference. If a child ate <3 meals/snacks per day, dose was given with meals/snacks. In DTP, starting dose of sevelamer carbonate was based on screening BSA & same as prescribed during FDP. Dose was titrated up/down every 2 weeks for 6 weeks & then every 4 weeks to achieve a serum phosphorus level within age appropriate normal values or up to maximum dose as per Investigator’s opinion. Dose titrations were based on BSA category: 0.2 g TID for BSA <0.75 m^2, 0.4 g TID for BSA ≥0.75 to < 1.2 m^2 & 0.8 g TID for BSA ≥1.2 m^2 (smaller titrations were permitted but could not be <0.2 g TID with meals/snacks).
757061|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP.
758089|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
757062|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter participants received sevelamer carbonate for 26 weeks in DTP.
757063|NCT01574326|O2|Outcome|FDP-Sevelamer Carbonate, DTP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP. Thereafter, participants continued to receive sevelamer carbonate for 26 weeks in DTP based on the screening BSA category.
757064|NCT01574326|O1|Outcome|FDP- Placebo for Sevelamer Carbonate; DTP– Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP. Thereafter, participants received sevelamer carbonate for 26 weeks in DTP.
757065|NCT01574326|O2|Outcome|FDP–Sevelamer Carbonate|Participants received sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for 2 weeks in FDP.
757066|NCT01574326|O1|Outcome|FDP-Placebo for Sevelamer Carbonate|Participants received placebo for sevelamer carbonate for first 2 weeks in FDP.
757067|NCT01574326|E3|Reported Event|DTP - Sevelamer Carbonate|Participants who received placebo and participants who received sevelamer carbonate in FDP received sevelamer carbonate for 26 weeks in DTP (median exposure of 183.5 days in participants who were on sevelamer carbonate in FDP and 183 days in participants who were on placebo in FDP).
757068|NCT01574326|E2|Reported Event|FDP - Sevelamer Carbonate|Participants exposed to sevelamer carbonate 0.4 g TID or 0.8 g TID or 1.6 g TID (based on the screening BSA category) for first 2 weeks in FDP (median exposure of 15 days).
757069|NCT01574326|E1|Reported Event|FDP - Placebo|Participants exposed to placebo (for sevelamer carbonate) for first 2 weeks in FDP (median exposure of 15 days).
757070|NCT01574248|B3|Baseline|Total|Total of all reporting groups
757071|NCT01574248|B2|Baseline|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757072|NCT01574248|B1|Baseline|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757073|NCT01574248|P2|Participant Flow|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757074|NCT01574248|P1|Participant Flow|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757075|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757076|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757077|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757078|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757079|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757080|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757081|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757082|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757083|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757084|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757085|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757086|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
757087|NCT01574248|O2|Outcome|Placebo|"Subcutaneous at time 0 and 6 hours~Placebo: Subcutaneous at time 0 and 6 hours"
757088|NCT01574248|O1|Outcome|Icatibant|"30 mg icatibant will be administered subcutaneously 0 and 6 hours after randomization~icatibant: Subcutaneous at time 0 and 6 hours"
758539|NCT01568073|E3|Reported Event|OPC 5mg|OPC, Opicapone 5mg
757101|NCT01574183|O1|Outcome|Vilazodone|"Flexible dose up to 40 mg capsule daily~Vilazodone: up to 40 mg capsule daily"
757102|NCT01574183|E2|Reported Event|Placebo|Flexible dose Placebo: up to 40 mg capsule daily
757103|NCT01574183|E1|Reported Event|Vilazodone|Flexible dose Vilazodone: up to 40 mg capsule daily
757104|NCT01574105|B3|Baseline|Total|Total of all reporting groups
757105|NCT01574105|B2|Baseline|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
757106|NCT01574105|B1|Baseline|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
757107|NCT01574105|P2|Participant Flow|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
757108|NCT01574105|P1|Participant Flow|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
757109|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
757110|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
757111|NCT01574105|O2|Outcome|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
757112|NCT01574105|O1|Outcome|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
757113|NCT01574105|E2|Reported Event|Heparin Sensitive|Patients whose heparin dose response slope was 90 sec/iu/ml or higher prior to surgery.
757114|NCT01574105|E1|Reported Event|Heparin Resistant|Patients whose heparin dose response slope was 89 sec/iu/ml or lower prior to surgery.
757115|NCT01574079|B3|Baseline|Total|Total of all reporting groups
757215|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757116|NCT01574079|B2|Baseline|Physical Therapy Plus Mirror Therapy|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
757117|NCT01574079|B1|Baseline|Traditional Physical Therapy|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
757118|NCT01574079|P2|Participant Flow|Physical Therapy Plus Mirror Therapy|The treatment group will receive traditional physical therapy with the addition of 15 minutes of mirror therapy consisting of lower extremity ankle dorsiflexion, knee flexion, and hip flexion. The participant will attempt to perform the exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
757119|NCT01574079|P1|Participant Flow|Traditional Physical Therapy|The control group will receive traditional physical therapy which includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
757120|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
757121|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
757122|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
757123|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
757124|NCT01574079|O2|Outcome|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
757125|NCT01574079|O1|Outcome|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
757126|NCT01574079|E2|Reported Event|Treatment Group|The treatment group received traditional physical therapy with the addition of mirror therapy. The mirror therapy consisted of 15 minutes of exercises for the lower extremities focusing on ankle dorsiflexion, knee flexion, and hip flexion. The participant attempted to perform the exercises with both lower extremities. The participant was blinded to the affected lower extremity with a mirror, and was looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performed the activities.
757127|NCT01574079|E1|Reported Event|Control Group|The control group received traditional physical therapy which included, but was not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
757128|NCT01573910|B3|Baseline|Total|Total of all reporting groups
757129|NCT01573910|B2|Baseline|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757130|NCT01573910|B1|Baseline|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757131|NCT01573910|P2|Participant Flow|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757132|NCT01573910|P1|Participant Flow|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757133|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757134|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757135|NCT01573910|O2|Outcome|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757136|NCT01573910|O1|Outcome|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757137|NCT01573910|E2|Reported Event|Ofloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757138|NCT01573910|E1|Reported Event|Moxifloxacin|1 drop instilled TID in each eye for 7 days with a TOC at Day 9
757139|NCT01573767|B5|Baseline|Total|Total of all reporting groups
757140|NCT01573767|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757141|NCT01573767|B3|Baseline|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757142|NCT01573767|B2|Baseline|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757143|NCT01573767|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757144|NCT01573767|P4|Participant Flow|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757145|NCT01573767|P3|Participant Flow|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757146|NCT01573767|P2|Participant Flow|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757147|NCT01573767|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757148|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757149|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757150|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757151|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757152|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757153|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757154|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757155|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757156|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757157|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757158|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757159|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757374|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757160|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757161|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757162|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757163|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757164|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757165|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757166|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
795072|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
757167|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757168|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757169|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757170|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757171|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757172|NCT01573767|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757173|NCT01573767|O3|Outcome|VI 12.5 µg OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757174|NCT01573767|O2|Outcome|VI 6.25 µg OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757175|NCT01573767|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757176|NCT01573767|E4|Reported Event|VI 25 OD|Participants received VI 25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757177|NCT01573767|E3|Reported Event|VI 12.5 OD|Participants received VI 12.5 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757178|NCT01573767|E2|Reported Event|VI 6.25 OD|Participants received vilanterol (VI) 6.25 µg OD in the evening from a dry powder inhaler for 4 weeks in addition to open-label FP 100 µg BID. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757179|NCT01573767|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from a dry powder inhaler for 4 weeks in addition to open-label fluticasone propionate (FP) 100 micrograms (µg) twice daily (BID). Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication.
757180|NCT01573325|B1|Baseline|Study Popoulation|There was only one group as this was a descriptive prospective study
757181|NCT01573325|P1|Participant Flow|Study Popoulation|There was only one group as this was a descriptive prospective study. They all completed identical questionnaires including the Quality of Life Index, the Short-form Liver Disease Quality of Life tool, the Medical Outcomes Study Social Support Survey, the demographic tool and the Center for Epidemiological Studies Depression tool.
757182|NCT01573325|O1|Outcome|Population Predicted by Have Poor HRQOL by Depressive Symptoms|
757183|NCT01573325|O1|Outcome|Study Popoulation|There was only one group as this was a descriptive prospective study
757184|NCT01573325|E1|Reported Event|Study Popoulation|There was only one group as this was a descriptive prospective study
757185|NCT01573260|B3|Baseline|Total|Total of all reporting groups
757186|NCT01573260|B2|Baseline|Tango|
757187|NCT01573260|B1|Baseline|Control|
757375|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757376|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757188|NCT01573260|P2|Participant Flow|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757189|NCT01573260|P1|Participant Flow|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757190|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757191|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757192|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757193|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
795388|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
757194|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757195|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757196|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757197|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757198|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757199|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757200|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757201|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757202|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757203|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757204|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757205|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757206|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757207|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757208|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757209|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757210|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757211|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757212|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Intervention: Patient will receive information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757213|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly class of argentinean tango for a period of 3-months the intervention for this arm~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757214|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757390|NCT01572792|E2|Reported Event|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757216|NCT01573260|O2|Outcome|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757217|NCT01573260|O1|Outcome|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757218|NCT01573260|E2|Reported Event|A 'Wait-list' Control Group|"Patient information about exercise in PD. After 12 weeks, these patients will then start the same 12-weeks tango program.~Simple pamphlet about the exercise in PD: Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual."
757219|NCT01573260|E1|Reported Event|Argentinean Tango|"A biweekly 3-month tango program~Argentinean Tango classes: Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors."
757220|NCT01573000|B3|Baseline|Total|Total of all reporting groups
757221|NCT01573000|B2|Baseline|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757222|NCT01573000|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757223|NCT01573000|P2|Participant Flow|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757224|NCT01573000|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757225|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757377|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
758540|NCT01568073|E2|Reported Event|Entacapone|Entacapone - 200 mg
757226|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757227|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757228|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757391|NCT01572792|E1|Reported Event|Placebo|Placebo administered BID by inhalation
757392|NCT01572740|B3|Baseline|Total|Total of all reporting groups
757229|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757230|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757231|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757232|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757233|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757234|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757235|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757236|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757249|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757237|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757238|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757239|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757240|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757241|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757242|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757243|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757244|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757245|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757246|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757247|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757248|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757250|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757251|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757252|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757253|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757254|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757255|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757256|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757257|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757258|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757259|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757260|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757378|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757379|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
758541|NCT01568073|E1|Reported Event|Placebo|Placebo 200 mg
757261|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757262|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757263|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757264|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757265|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757266|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757267|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757268|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757269|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757270|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757271|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757284|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757272|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757273|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757274|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757275|NCT01573000|O3|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757276|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757277|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757278|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757279|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757280|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757281|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757282|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757283|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757285|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757286|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757298|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757426|NCT01572727|P2|Participant Flow|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757287|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757288|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757289|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757290|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757291|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757292|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757293|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757294|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757295|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757308|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757296|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757297|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
758228|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
757299|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757300|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757301|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757302|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757303|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757304|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757305|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757306|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757307|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757328|NCT01572948|O2|Outcome|Placebo|500microgram white tablet
757329|NCT01572948|O1|Outcome|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
758542|NCT01568047|B5|Baseline|Total|Total of all reporting groups
757309|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757310|NCT01573000|O2|Outcome|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757333|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
757311|NCT01573000|O1|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757312|NCT01573000|O2|Outcome|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757313|NCT01573000|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757314|NCT01573000|E3|Reported Event|Unlabeled TST Crossover|Participants randomized to receive 450 mg and 35 mg of unlabelled TST IV during the DD and TD phase were allowed to crossover and receive I 131 TST using the same regimen used in the TST and Iodine I 131 TST treatment arm once their disease had progressed as long as they still fulfilled the protocol entry criteria. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757315|NCT01573000|E2|Reported Event|Unlabeled TST|Participants received a DD consisting of 450 mg and 35 mg of unlabelled TST IV. The TD consisting of 450 mg and 35 mg of TST IV was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757316|NCT01573000|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
757317|NCT01572948|B3|Baseline|Total|Total of all reporting groups
757318|NCT01572948|B2|Baseline|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
757319|NCT01572948|B1|Baseline|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
757320|NCT01572948|P2|Participant Flow|Placebo|500microgram white tablet
757321|NCT01572948|P1|Participant Flow|Roflumilast|group randomized to 30 day supply of white tablet 500microgram
757322|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
757323|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
757324|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
757325|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
757326|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
757327|NCT01572948|O1|Outcome|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
757330|NCT01572948|O2|Outcome|Daliresp|"The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models~roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models"
757331|NCT01572948|O1|Outcome|Placebo|"The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient.~placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient"
757332|NCT01572948|O2|Outcome|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
757986|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
757334|NCT01572948|E2|Reported Event|Roflumilast|roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
757335|NCT01572948|E1|Reported Event|Placebo|placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
757336|NCT01572792|B6|Baseline|Total|Total of all reporting groups
757337|NCT01572792|B5|Baseline|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757338|NCT01572792|B4|Baseline|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757339|NCT01572792|B3|Baseline|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757340|NCT01572792|B2|Baseline|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757341|NCT01572792|B1|Baseline|Placebo|Placebo administered BID by inhalation
757342|NCT01572792|P5|Participant Flow|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757343|NCT01572792|P4|Participant Flow|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757344|NCT01572792|P3|Participant Flow|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757345|NCT01572792|P2|Participant Flow|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757346|NCT01572792|P1|Participant Flow|Placebo|Placebo administered BID by inhalation
757347|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757348|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757349|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757350|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757351|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757352|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757353|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757354|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757355|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757356|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757357|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757358|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757359|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757360|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757361|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757362|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757363|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757364|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757365|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757366|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757367|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757368|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757369|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757370|NCT01572792|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757371|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757372|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757373|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
761716|NCT01553318|O1|Outcome|Ketotifen|active drug group
757380|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757381|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757382|NCT01572792|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757383|NCT01572792|O4|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757384|NCT01572792|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Aclidinium bromide 400 μg + formoterol fumurate 6 μg fixed dose combination (FDC) administered BID by inhalation
757385|NCT01572792|O2|Outcome|Aclidinium/Formmoterol 400/12 μg|Aclidinium bromide 400 μg + formoterol fumurate 12 μg fixed dose combination (FDC) administered BID by inhalation
757386|NCT01572792|O1|Outcome|Placebo|Placebo administered BID by inhalation
757387|NCT01572792|E5|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg administered BID by inhalation
757388|NCT01572792|E4|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered BID by inhalation
757987|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
757393|NCT01572740|B2|Baseline|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757394|NCT01572740|B1|Baseline|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757395|NCT01572740|P2|Participant Flow|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757396|NCT01572740|P1|Participant Flow|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757397|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757398|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757399|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757400|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757848|NCT01570309|P1|Participant Flow|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
757401|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757402|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757427|NCT01572727|P1|Participant Flow|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757428|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
758090|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
757403|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757404|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757405|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757406|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757407|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757408|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757409|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757410|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757411|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757412|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757413|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757414|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757415|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757416|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757417|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757418|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757419|NCT01572740|O2|Outcome|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757420|NCT01572740|O1|Outcome|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757421|NCT01572740|E2|Reported Event|Placebo + Insulin|"Liraglutide placebo was administered subcutaneously (s.c., under the skin) OD for 36 weeks combined with insulin therapy. The starting dose of the placebo was 50 μL/day; dose was escalated to100 μL/day and 150 μL/day during first 2 weeks; dose was maintained at 150 μL/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757454|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757455|NCT01572675|O3|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757849|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
757422|NCT01572740|E1|Reported Event|Lira + Insulin|"Liraglutide was administered subcutaneously (s.c., under the skin) once daily (OD) for 36 weeks combined with insulin therapy. The starting dose of the liraglutide was 0.3 mg (50 μL)/day; dose was escalated to 0.6 mg (100 μL)/day and 0.9 mg (150 μL)/day during first 2 weeks; dose was maintained at 0.9 mg (150 μL)/day for subsequent 34 weeks.~All subjects continued their pre-trial insulin therapy (basal: once daily [OD] or twice daily [BID], premixed: OD or BID or basal-bolus regimen [basal: OD or BID and bolus: three times a day]). Insulin dose was not changed for any subject for the first 16 weeks and for the subsequent 20 weeks, insulin dose was individually adjusted."
757423|NCT01572727|B3|Baseline|Total|Total of all reporting groups
757424|NCT01572727|B2|Baseline|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757425|NCT01572727|B1|Baseline|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757988|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
757429|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757430|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757431|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757432|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757433|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757434|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757435|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757436|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757437|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757438|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757439|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757440|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757441|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757442|NCT01572727|O2|Outcome|Placebo and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757443|NCT01572727|O1|Outcome|BKM120 and Paclitaxel|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757444|NCT01572727|E2|Reported Event|Placebo 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel
757445|NCT01572727|E1|Reported Event|Buparlisib (BKM120) 100 mg Plus Paclitaxel 80 mg Per m2|Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel
757446|NCT01572675|B3|Baseline|Total|Total of all reporting groups
757447|NCT01572675|B2|Baseline|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757448|NCT01572675|B1|Baseline|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757449|NCT01572675|P2|Participant Flow|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757450|NCT01572675|P1|Participant Flow|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757451|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757452|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757453|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757456|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757457|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757458|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757459|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757460|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757461|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757462|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757463|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757464|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757465|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757466|NCT01572675|O2|Outcome|Group Celebrex®|Participants who either previously received Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757467|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who either previously received Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757468|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757469|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757470|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757471|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757472|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757473|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757474|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757475|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757476|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757477|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757478|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757479|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757480|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757481|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757482|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757483|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757484|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757485|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757510|NCT01572675|O4|Outcome|More Than One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for more than one year
757486|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757487|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757488|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757489|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757490|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757491|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757492|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757493|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757494|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757495|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757496|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757497|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757498|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757499|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757500|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757501|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757502|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757503|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757504|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757602|NCT01571453|E1|Reported Event|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757850|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
757505|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757506|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757507|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757508|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757509|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757511|NCT01572675|O3|Outcome|From Three Months to One Year|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from three months to one year
757512|NCT01572675|O2|Outcome|From One to Three Months|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated from one to three months total
757513|NCT01572675|O1|Outcome|Up to Thirty Days|Participants who were either previously treated with Arcoxia® or Celebrex® or initiated on study treatment with Arcoxia® or Celebrex® and were treated for ≤ 30 days
757514|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757515|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757516|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757517|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757518|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757519|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757520|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757521|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757522|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757523|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757524|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757525|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757526|NCT01572675|O6|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757527|NCT01572675|O5|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757528|NCT01572675|O4|Outcome|Group Celebrex® - Renewal|Participants who started Celebrex® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757529|NCT01572675|O3|Outcome|Group Celebrex® - Initiation|Participants who initiated on study treatment with Celebrex® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757851|NCT01570309|O2|Outcome|Placebo|Sugar Pill
757852|NCT01570309|O1|Outcome|Active Therapy|Ergocalciferol 50,000 U q weekly x 12 weeks
757530|NCT01572675|O2|Outcome|Group Arcoxia® - Renewal|Participants who started Arcoxia® prior to study entry (prescription renewal). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757531|NCT01572675|O1|Outcome|Group Arcoxia® - Initiation|Participants who initiated on study treatment with Arcoxia® (treatment-naïve or had discontinued treatment at least 3 months prior). Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757532|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757533|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757534|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757776|NCT01571232|B2|Baseline|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
757535|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757536|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757537|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757538|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757539|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757540|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757541|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757542|NCT01572675|O2|Outcome|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757543|NCT01572675|O1|Outcome|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757544|NCT01572675|E2|Reported Event|Group Celebrex®|Participants who were either previously treated with Celebrex® or initiated on study treatment with Celebrex®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757545|NCT01572675|E1|Reported Event|Group Arcoxia®|Participants who were either previously treated with Arcoxia® or initiated on study treatment with Arcoxia®. Participant data in terms of dosage, treatment duration, and reasons for prescription was collected under actual conditions of use.
757546|NCT01572480|B1|Baseline|Carfilzomib, Revlimid & Dexamethasone|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757547|NCT01572480|P1|Participant Flow|Carfilzomib, Revlimid and Dexamethasone in Multiple Myeloma|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757548|NCT01572480|O1|Outcome|Carfilzomib, Revlimid & Dexamethasone|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757549|NCT01572480|O1|Outcome|Carfilzomib, Revlimid and Dexamethasone in Multiple Myeloma|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757853|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
757550|NCT01572480|O1|Outcome|Carfilzomib, Revlimid and Dexamethasone in Multiple Myeloma|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757551|NCT01572480|O1|Outcome|Carfilzomib, Revlimid and Dexamethasone in Multiple Myeloma|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757989|NCT01569763|E2|Reported Event|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
757552|NCT01572480|O1|Outcome|Carfilzomib, Revlimid and Dexamethasone in Multiple Myeloma|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757553|NCT01572480|O1|Outcome|Carfilzomib, Revlimid and Dexamethasone in Multiple Myeloma|"Drug: Carfilzomib~Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid~Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone~20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron"
757554|NCT01572480|E1|Reported Event|Carfilzomib, Revlimid and Dexamethasone in Multiple Myeloma|Drug: Carfilzomib Cycle 1 ONLY: Carfilzomib 20 mg/m(2) per dose, days 1 and 2; Carfilzomib 36 mg/m(2) per dose, days 8, 9, 15, and 16 Cycles 2-8: Carfilzomib 36 mg/m(2) per dose, days 1, 2, 8, 9, 15, and 16 Other Names: •Kyprolis Drug: Revlimid Cycles 1-8: 25 mg/day, days 1 - 21 every 28 days (exception: lenalidomide is NOT given on cycle 1, day 1) Cycles 9 and beyond: 25 mg/day, days 1 - 21 every 28 days Other Names: •Lenalidomide Drug: Dexamethasone 20 mg/dose, days 1, 2, 8, 9, 15, 16, 22, and 23 (exception: dexamethasone is NOT given on cycle 1, day 1) Other Names: •Decadron
757555|NCT01572298|B3|Baseline|Total|Total of all reporting groups
757556|NCT01572298|B2|Baseline|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757557|NCT01572298|B1|Baseline|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757558|NCT01572298|P2|Participant Flow|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757559|NCT01572298|P1|Participant Flow|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757560|NCT01572298|O2|Outcome|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757561|NCT01572298|O1|Outcome|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757562|NCT01572298|E2|Reported Event|Allograft Combined With Autograft|"guided bone regeneration with allograft and autograft combined (includes tenting screws and overlying allograft membrane material)~allograft combined wtih autograft (combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane): use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757563|NCT01572298|E1|Reported Event|Allograft Alone|"guided bone regeneration with allograft alone (includes tenting screws and overlying allograft membrane material)~allograft alone (MinerOss allograft plus Alloderm GBR membrane): use of MinerOss allograft plus Alloderm GBR membrane and tenting screws"
757564|NCT01572207|B3|Baseline|Total|Total of all reporting groups
757565|NCT01572207|B2|Baseline|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
757566|NCT01572207|B1|Baseline|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
757854|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
757855|NCT01570309|O2|Outcome|Sugar Pill|Matching Placebo
757567|NCT01572207|P2|Participant Flow|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
757568|NCT01572207|P1|Participant Flow|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
757569|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
757570|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
757571|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
757572|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
757573|NCT01572207|O2|Outcome|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
757574|NCT01572207|O1|Outcome|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
757575|NCT01572207|E2|Reported Event|Delayed Exercise|Subjects assigned to the delayed group will be asked to begin the same home exercise program 12 weeks following the first meeting. During the 12 week training period, the subject will receive pamphlets, have phone conversations with research staff, and complete physical activity surveys as described above.
757576|NCT01572207|E1|Reported Event|Immediate Exercise|Subjects assigned to the immediate group will be prescribed a home exercise program during the first meeting. During the 12 week training period, the subject will read pamphlets (sent by mail) once to twice a month about developing skills to manage MS symptoms and motivational pamphlets about physical activity. In addition, the subject will have a phone conversation every two to three weeks with research staff to discuss the progress of the exercise program and to complete a short survey about his/her physical activity level.
757577|NCT01571557|B1|Baseline|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
757578|NCT01571557|P1|Participant Flow|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
757579|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
757580|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
757581|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
757582|NCT01571557|O1|Outcome|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
757583|NCT01571557|E1|Reported Event|OZURDEX®|OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.
757584|NCT01571453|B3|Baseline|Total|Total of all reporting groups
757585|NCT01571453|B2|Baseline|Venlafaxine|Venlafaxine extended release: 150 mg/day
757586|NCT01571453|B1|Baseline|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757587|NCT01571453|P2|Participant Flow|Venlafaxine|Venlafaxine extended release 150 mg/day
757588|NCT01571453|P1|Participant Flow|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757589|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
757590|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757591|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
757592|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757593|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
757594|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757595|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
757596|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757597|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
757598|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757599|NCT01571453|O2|Outcome|Venlafaxine|Venlafaxine extended release: 150 mg/day
757600|NCT01571453|O1|Outcome|Vortioxetine|Vortioxetine (Lu AA21004): 10 mg/day
757601|NCT01571453|E2|Reported Event|Venlafaxine|Venlafaxine extended release: 150 mg/day
757603|NCT01571362|B1|Baseline|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757604|NCT01571362|P3|Participant Flow|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757645|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757605|NCT01571362|P2|Participant Flow|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757606|NCT01571362|P1|Participant Flow|Open ALO-02|Participants received AL0-02 extended-release capsules, orally (PO), twice daily (BID), at total daily doses of oxycodone from 20 to 160 milligrams (mg) in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757607|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757608|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757609|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757610|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757611|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757612|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757613|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757614|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757615|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757642|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757856|NCT01570309|O1|Outcome|Active|Ergocalciferal 50,000 U qweekly x 12 weeks
757857|NCT01570309|O2|Outcome|Sugar Pill|Matching placebo
761717|NCT01553318|O2|Outcome|Placebo|placebo group
757616|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757646|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
758229|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
757617|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757618|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757619|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757620|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757621|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757622|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757623|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757624|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757625|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757626|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757627|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757628|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757629|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757630|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757631|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757632|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757633|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757634|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757635|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757636|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757637|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757638|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757639|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757640|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757641|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757858|NCT01570309|O1|Outcome|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
757859|NCT01570309|E2|Reported Event|Sugar Pill|Matching placebo
757643|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757644|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
758230|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
757647|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757648|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757649|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757650|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757651|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757652|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757653|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757654|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757655|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757656|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757657|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757658|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757774|NCT01571362|E1|Reported Event|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757775|NCT01571232|B3|Baseline|Total|Total of all reporting groups
757990|NCT01569763|E1|Reported Event|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
757659|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757660|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757661|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757662|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757663|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757664|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757665|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757666|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757667|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757668|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757669|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757699|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757700|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757670|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757671|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757672|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757673|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757674|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757675|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757676|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757677|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757678|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757679|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757680|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757681|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757682|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757683|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757684|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
761718|NCT01553318|O1|Outcome|Ketotifen|active drug group
757739|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757685|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757686|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757687|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757688|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757689|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757690|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757691|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757692|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757693|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757694|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757695|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757696|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757697|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757698|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757701|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757702|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757703|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757704|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757705|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757706|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757707|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757708|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757709|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757710|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757711|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757712|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757727|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757860|NCT01570309|E1|Reported Event|Ergocalciferol|50,000 units of ergocalciferol once a week for 12 weeks
757979|NCT01569763|B2|Baseline|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
757713|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757714|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757715|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757716|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757717|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757718|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757719|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757720|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757721|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757722|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757723|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757724|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757725|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757726|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757728|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757729|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757730|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757731|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757732|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757733|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757734|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757735|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757736|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757737|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757738|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757861|NCT01570244|B1|Baseline|All Subjects|The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.
758075|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
757740|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757741|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757742|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757743|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757744|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757745|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757746|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757747|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757748|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757749|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757796|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757750|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757751|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757752|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757753|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757754|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757755|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757756|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757757|NCT01571362|O1|Outcome|Open ALO-02|Participants received AL0-02 extended-release capsules, orally PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator.
757758|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757759|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757760|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757761|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757797|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
757980|NCT01569763|B1|Baseline|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Minerva Endometrial Ablation system
761719|NCT01553318|O2|Outcome|Placebo|placebo group
757762|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757763|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757764|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757765|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757766|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757767|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757768|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757769|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757770|NCT01571362|O2|Outcome|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757771|NCT01571362|O1|Outcome|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757772|NCT01571362|E3|Reported Event|ALO-02 To ALO-02|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, received a dummy-taper but continued to receive double-blind ALO-02 capsules PO BID at a fixed dose (specifically the ALO-02 fixed dose that had not changed with the 7 consecutive days prior to randomization) for 12 weeks.
757798|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
757981|NCT01569763|P2|Participant Flow|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
757773|NCT01571362|E2|Reported Event|ALO-02 To Placebo|Participants received AL0-02 extended-release capsules PO BID at total daily doses of oxycodone from 20 to 160 mg in the Open-Label Conversion and Titration Period for 4 to 6 weeks; titration was at the discretion of the investigator. If a participant met protocol-defined treatment response criteria at the end of open-label Week 4, 5, or 6, the participant was randomized into the Double-Blind Treatment Period, underwent a double-blind gradual taper of ALO-02 to discontinue use over the first 2 weeks, and then received double-blind placebo capsules PO BID for 10 weeks.
757777|NCT01571232|B1|Baseline|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
757778|NCT01571232|P2|Participant Flow|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
757779|NCT01571232|P1|Participant Flow|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
757780|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
757781|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
757782|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
757783|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
757784|NCT01571232|O2|Outcome|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
757785|NCT01571232|O1|Outcome|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
757786|NCT01571232|E2|Reported Event|Avastin|"Patients in this group receive Avastin Q1 month for 5 months.~intravitreal bevacizumab: Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments."
757787|NCT01571232|E1|Reported Event|Ozurdex|"Patients in this group receive Ozurdex at initial visit and at month 4~dexamethasone intravitreal implant: Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)"
757788|NCT01570751|B3|Baseline|Total|Total of all reporting groups
757789|NCT01570751|B2|Baseline|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757790|NCT01570751|B1|Baseline|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757791|NCT01570751|P2|Participant Flow|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757792|NCT01570751|P1|Participant Flow|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757793|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
757794|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
757795|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757842|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
757799|NCT01570751|O2|Outcome|IGlar/IDeg|The subjects in this arm for treatment period A received IGlar OD (100 U/mL in SoloStar® pen) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IDeg OD (200 U/mL in pre-filled pen device) for 16 weeks (treatment period B). Subjects were crossed over to IDeg without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757800|NCT01570751|O1|Outcome|IDeg/IGlar|The subjects in this arm for treatment period A received IDeg OD (200 U/mL in pre-filled pen device) subcutaneously (under the skin) for 16 weeks (treatment period A) followed by IGlar OD (100 U/mL in SoloStar® pen) for 16 weeks (treatment period B). Subjects were crossed over to IGlar without a wash-out period between the two treatment sequences. Subjects continued on metformin (pre-trial dose) throughout the trial. There was a follow-up visit 7 days following the last treatment visit.
757991|NCT01569568|B3|Baseline|Total|Total of all reporting groups
758091|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
757801|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
757802|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
757803|NCT01570751|O2|Outcome|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
757804|NCT01570751|O1|Outcome|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
757805|NCT01570751|E2|Reported Event|IGlar|Subjects received IGlar OD (100 U/mL in Solostar® pen) subcutaneously (under the skin)for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IDeg, subjects either received IGlar in treatment period A or treatment period B.
757806|NCT01570751|E1|Reported Event|IDeg|Subjects received IDeg OD (200 U/mL in prefilled pen device) subcutaneously (under the skin) for 16 weeks in combination with metformin (pre-trial dose). As this was a 32-week cross-over trial with IGlar, subjects either received IDeg in treatment period A or treatment period B.
757807|NCT01570686|B3|Baseline|Total|Total of all reporting groups
757808|NCT01570686|B2|Baseline|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757809|NCT01570686|B1|Baseline|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757810|NCT01570686|P2|Participant Flow|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757811|NCT01570686|P1|Participant Flow|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757812|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757813|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757814|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757815|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757816|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757817|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757818|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757819|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757820|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757821|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757822|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757823|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757824|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757825|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757826|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757827|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757828|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757829|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757830|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757831|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757832|NCT01570686|O2|Outcome|Aliskiren: Fasting|Aliskiren 300 mg once daily taken after after an overnight fast
757833|NCT01570686|O1|Outcome|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757834|NCT01570686|E2|Reported Event|Aliskiren 300 mg (Fasted)|Aliskiren 300 mg once daily taken after after an overnight fast
757835|NCT01570686|E1|Reported Event|Aliskiren: Fed|Aliskiren 300 mg once daily, taken 30 minutes after start of light breakfast
757836|NCT01570634|B1|Baseline|Open Label CASAD|Treatment with CASAD for 14 days
757837|NCT01570634|P1|Participant Flow|Open Label CASAD|Treatment with Calcium Aluminosilicate Anti-Diarrheal (CASAD) for 14 days
757838|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
757839|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
757840|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
757841|NCT01570634|O1|Outcome|Open Label CASAD|Treatment with CASAD for 14 days
757862|NCT01570244|P1|Participant Flow|All Subjects|"The trial was a nonrandomised, noncontrolled, open-label, 2-period fixed-sequence trial to evaluate the possible effect of multiple doses of faldaprevir on the multiple-dose pharmacokinetics of a combination of ethinylestradiol and levonorgestrel. The trial was to be performed in 16 healthy female volunteers.~Period 1: Microgynon (150 μg Ethinylestradiol+30 μg Levonorgestrel) tablets.~Period 2: Microgynon tablets and Faldaprevir."
757863|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757864|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
758221|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
757865|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757866|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757867|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757868|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757869|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757870|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757871|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757872|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757873|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757874|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757875|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757876|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757877|NCT01570244|O2|Outcome|Microgynon + Faldaprevir|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757878|NCT01570244|O1|Outcome|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757879|NCT01570244|E2|Reported Event|Microgynon + BI 201335|"Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.~Faldaprevir: loading dose of 480 mg (morning and evening doses of 240 mg on Day 1 of Period 2), on subsequent days 240 mg once daily in the morning."
757880|NCT01570244|E1|Reported Event|Microgynon|Multiple doses of Microgynon (150 µg Ethinylestradiol+30 µg Levonorgestrel) tablets once daily in the morning.
757881|NCT01570192|B3|Baseline|Total|Total of all reporting groups
757882|NCT01570192|B2|Baseline|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
757883|NCT01570192|B1|Baseline|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
757910|NCT01569828|P2|Participant Flow|Matched Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.Once daily administration of 400 mg LCZ696 p.o. for 5 days
757884|NCT01570192|P2|Participant Flow|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
758222|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
757885|NCT01570192|P1|Participant Flow|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
757886|NCT01570192|O2|Outcome|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
757887|NCT01570192|O1|Outcome|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
757888|NCT01570192|E2|Reported Event|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat Gram-positive pathogens.~**NOTE: Empiric MRSA coverage is allowed in both arms. This therapy is advised for any subjects with known or suspected MRSA entering the study. Once microbiologic results are available, this coverage may be discontinued at the investigator's discretion.~I.V. Meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage."
757889|NCT01570192|E1|Reported Event|IV Meropenem; Parenteral Aminoglycoside|"Subjects assigned to this group will receive:~IV meropenem (2 g infused over 3 hrs q 8 hr);~a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~tobramycin nebulization~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage to treat potential Gram-positive pathogens.~IV meropenem: Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).~Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h: a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)~Linezolid or Vancomcin (per institutional guidelines) will be available for MRSA coverage.: Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.~tobramycin nebulization: tobramycin nebulization 600mg/day"
757890|NCT01569841|B1|Baseline|Full Analysis Set|The full analysis set (FAS) included all randomised subjects.
757891|NCT01569841|P2|Participant Flow|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
757911|NCT01569828|P1|Participant Flow|Severe Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
761720|NCT01553318|O1|Outcome|Ketotifen|active drug group
757912|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757992|NCT01569568|B2|Baseline|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
757892|NCT01569841|P1|Participant Flow|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
757893|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
757894|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
757895|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
757896|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
757897|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
757898|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
757899|NCT01569841|O2|Outcome|IGlar/IDeg|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IGlar/IDeg treatment sequence received an morning dose of IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks in treatment Period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) subcutaneously (under the skin) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) for 6 weeks."
757971|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757972|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757973|NCT01569815|E5|Reported Event|LCZ696 400 mg - All Healthy Subjects|LCZ696 400 mg - All healthy subjects
757974|NCT01569815|E4|Reported Event|LCZ696 400 mg - Moderate - Matched Healthy Subjects|LCZ696 400 mg - Moderate - Matched healthy subjects
757900|NCT01569841|O1|Outcome|IDeg/IGlar|"The trial included 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~All randomised subjects were scheduled for 12 weeks of treatment with the trial products. After 6 weeks of treatment in period A, the subjects were crossed over to 6 weeks of the other treatment in period B.~Upon completing the 4-week run-in period, subjects randomised to the IDeg/IGlar treatment sequence received an morning dose of IDeg OD (100 U/mL, 3 mL prefilled pen) along with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks in treatment period A. Upon completion of treatment Period A, subjects crossed over to Period B and received a morning dose of IGlar OD (100 U/mL, SoloStar® prefilled pen) in combination with mealtime dosing of IAsp (100 U/mL, prefilled pen) subcutaneously (under the skin) for 6 weeks."
757901|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
757902|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
757903|NCT01569841|O2|Outcome|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
757904|NCT01569841|O1|Outcome|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
757905|NCT01569841|E2|Reported Event|IGlar|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to IGlar OD (100 U/mL, 3 mL SoloStar® prefilled pen s.c., morning dose) in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IDeg OD (100 U/mL, prefilled pen s.c., morning dose) for 6 weeks in combination with mealtime IAsp (100 U/mL, prefilled pen s.c.) for 6 weeks."
757906|NCT01569841|E1|Reported Event|IDeg|"The trial included a screening period of approximately one week, a run-in period of 4 weeks followed by 2 treatment periods of 6 weeks each in a cross-over design, and a follow-up visit no less than 7 days after the last treatment visit. Total trial duration for the individual subject was 18 weeks.~Treatment period A: Subjects from run-in period were randomised to insulin degludec (IDeg) OD (100 U/mL, 3 mL prefilled pen, morning dose) administered subcutaneously (under the skin) in combination with mealtime IAsp (100 U/mL, pre-filled pen) for 6 weeks.~Treatment period B: Subjects (from treatment period A) were crossed over to IGlar OD (100 U/mL, SoloStar® prefilled pen, morning dose) in combination with mealtime IAsp (100 U/mL, s.c., prefilled pen) for 6 weeks."
757907|NCT01569828|B3|Baseline|Total|Total of all reporting groups
757908|NCT01569828|B2|Baseline|Matched Healthy Volunteers|"All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
757909|NCT01569828|B1|Baseline|Severe Renal Impaired Subjects|"Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.~Once daily administration of 400 mg LCZ696 p.o. for 5 days"
757975|NCT01569815|E3|Reported Event|LCZ696 400 mg - Moderate - Renal Impaired Patients|LCZ696 400 mg - Moderate - Renal impaired patients
757976|NCT01569815|E2|Reported Event|LCZ696 400 mg - Mild - Matched Healthy Subjects|LCZ696 400 mg - Mild - Matched healthy subjects
757977|NCT01569815|E1|Reported Event|LCZ696 400 mg - Mild - Renal Impaired Patients|LCZ696 400 mg - Mild - Renal impaired patients
757978|NCT01569763|B3|Baseline|Total|Total of all reporting groups
757913|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement.Once daily administration of 400 mg LCZ696 p.o. for 5 days
757914|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757915|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757916|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757917|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757918|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757919|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757920|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757921|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757922|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757923|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757924|NCT01569828|O2|Outcome|Healthy Volunteers|All healthy volunteers were matched by age (±5 years), sex and BMI (±10%) to the renal subjects enrolled into the study. Subjects were to be in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.2 °C, systolic blood pressure (95-140 mm Hg), diastolic blood, pressure (60-100 mm Hg), pulse rate (45-90 bpm), laboratory tests and urinalysis. Healthy subjects must have a CrCl of >80 mL/min. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757925|NCT01569828|O1|Outcome|Renal Impaired Subjects|Subjects with severe (CrCl from <30 mL/min), renal function who were otherwise in good health as determined by past medical history, physical examination, electrocardiogram, vital signs (measured after 3 minutes rest in the supine position) which are within the following ranges; oral body temperature between 35.0-37.8°C, systolic blood pressure (95-180 mm Hg), diastolic blood pressure (60-110 mm Hg), pulse rate (54-95 bpm), laboratory tests and urinalysis. Creatinine clearance (CrCl) was calculated by the Cockcroft-Gault (CG) formula with patient stratification based on the screening serum creatinine measurement. Once daily administration of 400 mg LCZ696 p.o. for 5 days
757926|NCT01569828|E2|Reported Event|Matched Healthy Volunteers|
757927|NCT01569828|E1|Reported Event|Severe Renal Impaired Patients|
757928|NCT01569815|B5|Baseline|Total|Total of all reporting groups
757929|NCT01569815|B4|Baseline|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757930|NCT01569815|B3|Baseline|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757931|NCT01569815|B2|Baseline|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757932|NCT01569815|B1|Baseline|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757933|NCT01569815|P4|Participant Flow|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757934|NCT01569815|P3|Participant Flow|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757935|NCT01569815|P2|Participant Flow|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757936|NCT01569815|P1|Participant Flow|Mild Renal Impaired|LCZ696 400 mg once daily for 5 days
757937|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757938|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757939|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757940|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757941|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757942|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757943|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757944|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757945|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757946|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757947|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757948|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757949|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757950|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757951|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757952|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757953|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757954|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757955|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757956|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757957|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757958|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757959|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757960|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757961|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757962|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757963|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757964|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757965|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757966|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757967|NCT01569815|O2|Outcome|Mild Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757968|NCT01569815|O1|Outcome|Mild Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757969|NCT01569815|O4|Outcome|Moderate Renal Impaired Matched Healthy Subjects|LCZ696 400 mg once daily for 5 days
757970|NCT01569815|O3|Outcome|Moderate Renal Impaired Subjects|LCZ696 400 mg once daily for 5 days
757982|NCT01569763|P1|Participant Flow|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
757983|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
757984|NCT01569763|O1|Outcome|Aurora Endometrial Ablation|Aurora Endometrial Ablation: Endometrial Ablation using the Aurora Endometrial Ablation system
757985|NCT01569763|O2|Outcome|Hysteroscopic Rollerball Resection/Ablation|Rollerball Ablation/Resection: Hysteroscopic rollerball resection/ablation
757993|NCT01569568|B1|Baseline|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
757994|NCT01569568|P2|Participant Flow|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
757995|NCT01569568|P1|Participant Flow|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H Magnetic Resonance Spectroscopy (MRS), Diffusion Tensor Imaging (DTI), functional magnetic resonance imaging (fMRI)~Cognitive testing: Neuropsychological testing"
757996|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
757997|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
757998|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
757999|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
758000|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
758001|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
758002|NCT01569568|O2|Outcome|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
758003|NCT01569568|O1|Outcome|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
758004|NCT01569568|E2|Reported Event|Healthy Controls|"males and females ages 7-60 years who are healthy controls~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
758005|NCT01569568|E1|Reported Event|Subjects With OTCD|"males and females ages 7-60 years with OTCD~MRI scanning: 1H MRS, DTI, FMRI~Cognitive testing: Neuropsychological testing"
758006|NCT01569529|B3|Baseline|Total|Total of all reporting groups
758007|NCT01569529|B2|Baseline|No ad Exposure|Young adults, who registered for the cessation program, one month prior to presenting the online advertisements (intervention).
758008|NCT01569529|B1|Baseline|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
758009|NCT01569529|P2|Participant Flow|No Ad Exposure|Young adults, who registered for the cessation program, after arriving at the program site though established means (e.g., search engine results), one month prior to presenting the tailored online advertisements (intervention).
758010|NCT01569529|P1|Participant Flow|Ad Exposure|"Young Adults, who register for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
758011|NCT01569529|O2|Outcome|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
758012|NCT01569529|O1|Outcome|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
758013|NCT01569529|E2|Reported Event|No ad Exposure|Young adults, who enrolled for the cessation program, one month prior to presenting the online advertisements (intervention).
758014|NCT01569529|E1|Reported Event|Ad Exposure|"Young Adults, who enrolled for the cessation program, by clicking through the online advertisements (intervention).~Online advertisement : Internet advertisement with messages tailored for young adult smoker's motivated to quit"
758015|NCT01569464|B3|Baseline|Total|Total of all reporting groups
758016|NCT01569464|B2|Baseline|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758017|NCT01569464|B1|Baseline|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758018|NCT01569464|P2|Participant Flow|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758019|NCT01569464|P1|Participant Flow|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg / 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758020|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758021|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758022|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758086|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758087|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758231|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758023|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758024|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758025|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758026|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758027|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758028|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/r24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758029|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758030|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758031|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758032|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758033|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758034|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758035|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758036|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758037|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758038|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758073|NCT01569152|P2|Participant Flow|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758074|NCT01569152|P1|Participant Flow|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758039|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758040|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758041|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758042|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758043|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758044|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758045|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758046|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758047|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758048|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/r24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758049|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758050|NCT01569464|O2|Outcome|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758051|NCT01569464|O1|Outcome|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758052|NCT01569464|E2|Reported Event|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours~7 weeks"
758053|NCT01569464|E1|Reported Event|Rotigotine|"Rotigotine patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.~Rotigotine: Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:~Rotigotine 1 mg/ 24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours~7 weeks (titration plus maintenance)"
758054|NCT01569438|B3|Baseline|Total|Total of all reporting groups
758055|NCT01569438|B2|Baseline|Sugar Pill|Sugar Pill: Placebo
758056|NCT01569438|B1|Baseline|Gefapixant|Gefapixant: BID
758057|NCT01569438|P2|Participant Flow|Gefapixant|Gefapixant: BID
758058|NCT01569438|P1|Participant Flow|Sugar Pill|Sugar Pill: Placebo
758059|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
758060|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
758061|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
758062|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
758063|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
758064|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
758065|NCT01569438|O2|Outcome|Sugar Pill|Sugar Pill: Placebo
758066|NCT01569438|O1|Outcome|Gefapixant|Gefapixant: BID
758067|NCT01569438|E2|Reported Event|Gefapixant|Gefapixant: BID
758068|NCT01569438|E1|Reported Event|Sugar Pill|Sugar Pill: Placebo
758069|NCT01569152|B3|Baseline|Total|Total of all reporting groups
758070|NCT01569152|B2|Baseline|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758071|NCT01569152|B1|Baseline|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758072|NCT01569152|P3|Participant Flow|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
758543|NCT01568047|B4|Baseline|BIA 9-1067 (30 mg)|30 mg BIA 9-1067 - OPC, Opicapone
758076|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758077|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758078|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758079|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758080|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758081|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758082|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758083|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758084|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758085|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758092|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758093|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758094|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758095|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758096|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758097|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758098|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758099|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758100|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758101|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758102|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758103|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758104|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758105|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758106|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758107|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758108|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758109|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758110|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758111|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758112|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758113|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758114|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758115|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758116|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758117|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758118|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758119|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758120|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758121|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758122|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758123|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758124|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758125|NCT01569152|O2|Outcome|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758126|NCT01569152|O1|Outcome|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758127|NCT01569152|E3|Reported Event|Safety Extension Period 3: MK-8457|MK-8457 100 mg BID + MTX for up to approximately 52 weeks in Safety Extension Period 3. Participants who completed or had early escape from Base Study Phase IIa were eligible to enroll in Safety Extension Period 3.
758128|NCT01569152|E2|Reported Event|Base Study Phase IIa: Placebo|Placebo + MTX for up to 24 weeks in Base Study Phase IIa
758129|NCT01569152|E1|Reported Event|Base Study Phase IIa: MK-8457|MK-8457 100mg BID + MTX for up to 24 weeks in Base Study Phase IIa
758130|NCT01569126|B7|Baseline|Total|Total of all reporting groups
758131|NCT01569126|B6|Baseline|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758132|NCT01569126|B5|Baseline|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758133|NCT01569126|B4|Baseline|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758134|NCT01569126|B3|Baseline|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758135|NCT01569126|B2|Baseline|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758136|NCT01569126|B1|Baseline|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758137|NCT01569126|P6|Participant Flow|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758138|NCT01569126|P5|Participant Flow|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758139|NCT01569126|P4|Participant Flow|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758140|NCT01569126|P3|Participant Flow|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758141|NCT01569126|P2|Participant Flow|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758142|NCT01569126|P1|Participant Flow|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758143|NCT01569126|O6|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758144|NCT01569126|O5|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758145|NCT01569126|O4|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758146|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758147|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758148|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758149|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758150|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758151|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758152|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758153|NCT01569126|O2|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758154|NCT01569126|O1|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758155|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758156|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
761721|NCT01553318|O2|Outcome|Placebo|received placebo
758157|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758158|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758159|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758160|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758161|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758162|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758163|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758164|NCT01569126|O3|Outcome|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758165|NCT01569126|O2|Outcome|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758223|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758224|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758166|NCT01569126|O1|Outcome|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28, participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758167|NCT01569126|O3|Outcome|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758168|NCT01569126|O2|Outcome|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758169|NCT01569126|O1|Outcome|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758170|NCT01569126|E6|Reported Event|40 mg LY110140 (MD)|Participants, in Cohort 5, who received two 20-mg LY110140 (fluoxetine hydrochloride) capsules, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758171|NCT01569126|E5|Reported Event|20 mg LY110140 (MD)|Participants, in Cohort 4, who received 20-mg LY110140 (fluoxetine hydrochloride) capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758172|NCT01569126|E4|Reported Event|Placebo (MD)|Participants, in Cohorts 4 and 5, who received a placebo capsule, orally administered once daily for 28 days, during the MD period. On Days 1 and 28 participants were required to fast at least 8 hours prior to dosing and 4 hours postdose.
758173|NCT01569126|E3|Reported Event|40 mg LY110140 (SD)|Cohort 3: 40-mg LY110140 (fluoxetine hydrochloride) dose (two 20-mg LY110140 capsules) orally administered once, in a fasted state, during the SD period.
758174|NCT01569126|E2|Reported Event|20 mg LY110140 (SD)|Cohort 2: 20-mg LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758175|NCT01569126|E1|Reported Event|5 mg LY110140 (SD)|Cohort 1: 5-milligram (mg) LY110140 (fluoxetine hydrochloride) capsule orally administered once, in a fasted state, during the SD period.
758176|NCT01569087|B4|Baseline|Total|Total of all reporting groups
758177|NCT01569087|B3|Baseline|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758178|NCT01569087|B2|Baseline|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758179|NCT01569087|B1|Baseline|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758180|NCT01569087|P3|Participant Flow|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758181|NCT01569087|P2|Participant Flow|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758182|NCT01569087|P1|Participant Flow|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758183|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758184|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758185|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758186|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758187|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758188|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758225|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758226|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758227|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758189|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758190|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758191|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758192|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758193|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758194|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758195|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758196|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758197|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758198|NCT01569087|O3|Outcome|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758199|NCT01569087|O2|Outcome|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758200|NCT01569087|O1|Outcome|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758201|NCT01569087|E3|Reported Event|Filgrastim|"Patients will receive filgrastim subcutaneously daily (until ANC 10 000/μL or for 14 days, whichever occurred first), starting 24 h after the chemotherapy~filgrastim: Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir."
758202|NCT01569087|E2|Reported Event|Empegfilgrastim 6 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 6 mg subcutaneously, 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758544|NCT01568047|B3|Baseline|BIA 9-1067 (15 mg)|15 mg BIA 9-1067 - OPC, Opicapone
758203|NCT01569087|E1|Reported Event|Empegfilgrastim 3 mg|"Patients will receive a single administration of empegfilgrastim at a dose of 3 mg subcutaneously , 24 h after the chemotherapy~empegfilrastim: Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg."
758204|NCT01569074|B6|Baseline|Total|Total of all reporting groups
758205|NCT01569074|B5|Baseline|PLACEBO PO|Dosing Group E
758206|NCT01569074|B4|Baseline|FOSTA 50 MG BID PO|Dosing Group D
758207|NCT01569074|B3|Baseline|FOSTA 75 MG BID PO|Dosing Group C
758208|NCT01569074|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758209|NCT01569074|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
758210|NCT01569074|P5|Participant Flow|PLACEBO PO|Dosing Group E
758211|NCT01569074|P4|Participant Flow|FOSTA 50 MG BID PO|Dosing Group D
758212|NCT01569074|P3|Participant Flow|FOSTA 75 MG BID PO|Dosing Group C
758213|NCT01569074|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758214|NCT01569074|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
758215|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758216|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758217|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758218|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758219|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758220|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758233|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758234|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758235|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758236|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758237|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758238|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758239|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758240|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758241|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758242|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758243|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758244|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758245|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758246|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758247|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758248|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758249|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758250|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758251|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758252|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758253|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758254|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758255|NCT01569074|O4|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758256|NCT01569074|O3|Outcome|PLACEBO PO|Dosing Group E
758257|NCT01569074|O2|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758258|NCT01569074|O1|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758259|NCT01569074|O5|Outcome|PLACEBO PO|Dosing Group E
758260|NCT01569074|O4|Outcome|FOSTA 50 MG BID PO|Dosing Group D
758261|NCT01569074|O3|Outcome|FOSTA 75 MG BID PO|Dosing Group C
758262|NCT01569074|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758263|NCT01569074|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
758264|NCT01569074|E5|Reported Event|PLACEBO PO|Dosing Group E
758265|NCT01569074|E4|Reported Event|FOSTA 75 MG BID PO|Dosing Group C
758266|NCT01569074|E3|Reported Event|FOSTA 50 MG BID PO|Dosing Group D
758267|NCT01569074|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
758268|NCT01569074|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
758269|NCT01568905|B4|Baseline|Total|Total of all reporting groups
758270|NCT01568905|B3|Baseline|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette (10.4 mg/g; menthol: 12.3): smoke the study cigarette exclusively for one week
758271|NCT01568905|B2|Baseline|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette (5.86 mg/g menthol 5.87 mg/g): smoke the study cigarette exclusively for one week
758272|NCT01568905|B1|Baseline|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette (0.400 mg/g; menthol 0.405 mg/g): smoke the study cigarette exclusively for one week
758273|NCT01568905|P3|Participant Flow|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
758274|NCT01568905|P2|Participant Flow|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
758275|NCT01568905|P1|Participant Flow|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
758276|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
758277|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
758278|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
758279|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
758280|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
758281|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
758282|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
758283|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
758284|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
758285|NCT01568905|O3|Outcome|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
758286|NCT01568905|O2|Outcome|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
758287|NCT01568905|O1|Outcome|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
758288|NCT01568905|E3|Reported Event|Arm 3 High Level Nicotine Cigarette|High level nicotine cigarette: smoke the study cigarette exclusively for one week
758289|NCT01568905|E2|Reported Event|Arm 2 Intermediate Nicotine Level Cigarette|Intermediate nicotine level cigarette: smoke the study cigarette exclusively for one week
758290|NCT01568905|E1|Reported Event|Arm 1 Low Level Nicotine Cigarette|Low level nicotine cigarette: smoke the study cigarette exclusively for one week
758291|NCT01568892|B3|Baseline|Total|Total of all reporting groups
758292|NCT01568892|B2|Baseline|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
759037|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
758293|NCT01568892|B1|Baseline|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758294|NCT01568892|P2|Participant Flow|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758295|NCT01568892|P1|Participant Flow|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758296|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758297|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758298|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758299|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758300|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758301|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758302|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758303|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758378|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758304|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758305|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758306|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758307|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758308|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758309|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758310|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
796546|NCT01412944|B3|Baseline|Total|Total of all reporting groups
758311|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758312|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758313|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758314|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758315|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758316|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758317|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758318|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758319|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758320|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758321|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758379|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
761722|NCT01553318|O1|Outcome|Ketotifen|Ketotifen active drug
758322|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758323|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758324|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758325|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758326|NCT01568892|O2|Outcome|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758327|NCT01568892|O1|Outcome|DTG 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758328|NCT01568892|E2|Reported Event|Placebo BID in DB Phase; DTG 50 mg BID in Open-label Phase|Participants received matching placebo BID and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the DB Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758329|NCT01568892|E1|Reported Event|DTG 50mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice daily (BID) and the components of their current failing antiretroviral regimen, except raltegravir or elvitegravir, for 7 days during the Double-blind (DB) Phase. From Day 8, all participants continued to receive DTG 50 mg BID with an optimized background regimen in the Open-label Phase.
758330|NCT01568866|B3|Baseline|Total|Total of all reporting groups
758331|NCT01568866|B2|Baseline|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758332|NCT01568866|B1|Baseline|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758333|NCT01568866|P2|Participant Flow|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758334|NCT01568866|P1|Participant Flow|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758335|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758336|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758337|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758338|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758339|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758340|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758341|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758342|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758411|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758343|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758344|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758345|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758346|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758347|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758348|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758349|NCT01568866|O2|Outcome|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758350|NCT01568866|O1|Outcome|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758652|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758351|NCT01568866|E2|Reported Event|Carfilzomib + DEX|Participants received 20 mg/m² carfilzomib administered by IV infusion on Days 1 and 2 of Cycle 1, followed by 56 mg/m² on Days 8, 9, 15, and 16 of Cycle 1 and for each 28-day cycle thereafter. Additionally, participants received 20 mg dexamethasone on Days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28 day cycle.
758352|NCT01568866|E1|Reported Event|Bortezomib + DEX|Participants received bortezomib 1.3 mg/m² administered intravenously (IV) or subcutaneously (SC) on Days 1, 4, 8, and 11 of a 21-day cycle plus dexamethasone (DEX) 20 mg administered on Days 1, 2, 4, 5, 8, 9, 11, and 12 of each 21-day cycle.
758353|NCT01568827|B3|Baseline|Total|Total of all reporting groups
758354|NCT01568827|B2|Baseline|No Intervention|Water without lypholized black raspberry powder
758355|NCT01568827|B1|Baseline|Black-raspberry Powder|Black-raspberry powder: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries
758356|NCT01568827|P2|Participant Flow|Blackraspberry Slurry First, Then Washout, Then Water|Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
758357|NCT01568827|P1|Participant Flow|Water First, Then Washout, Then Blackraspberry Slurry|8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
758358|NCT01568827|O2|Outcome|Blackraspberry Slurry|Blackraspberry slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries mixed with 8 oz water
758359|NCT01568827|O1|Outcome|Water|Water without lypholized black raspberry powder
758360|NCT01568827|E2|Reported Event|Water, Washout, Black-raspberry Slurry|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
758361|NCT01568827|E1|Reported Event|Black-raspberry Slurry, Washout, Water|Black-raspberry Slurry: Black-raspberry powder (45g) equivalent to about 450 g fresh black raspberries.
758362|NCT01568593|B3|Baseline|Total|Total of all reporting groups
758363|NCT01568593|B2|Baseline|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
758364|NCT01568593|B1|Baseline|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
758365|NCT01568593|P2|Participant Flow|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
758366|NCT01568593|P1|Participant Flow|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
758367|NCT01568593|O2|Outcome|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
758368|NCT01568593|O1|Outcome|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
758369|NCT01568593|E2|Reported Event|Vismed|Vismed: 1 drop in each eye 3 to 6 times daily during 84 days
758370|NCT01568593|E1|Reported Event|T2750|T2750: 1 drop in each eye 3 to 6 times daily during 84 days
758371|NCT01568424|B1|Baseline|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758372|NCT01568424|P1|Participant Flow|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758373|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758374|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758375|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758376|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758377|NCT01568424|O1|Outcome|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758380|NCT01568424|E1|Reported Event|Treatment Group|"Patients with acute right ventricular failure from any cause requiring use of the CentriMag RVAS to sustain life.~CentriMag RVAS placement: Patients will be treated with a CentriMag RVAS"
758381|NCT01568112|B5|Baseline|Total|Total of all reporting groups
758382|NCT01568112|B4|Baseline|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758383|NCT01568112|B3|Baseline|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758384|NCT01568112|B2|Baseline|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758385|NCT01568112|B1|Baseline|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758386|NCT01568112|P4|Participant Flow|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758387|NCT01568112|P3|Participant Flow|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758388|NCT01568112|P2|Participant Flow|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758389|NCT01568112|P1|Participant Flow|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758390|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758391|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758392|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758393|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758394|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758395|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758396|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758397|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758398|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758399|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758400|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758401|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758402|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758403|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758404|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758405|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758406|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758407|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758408|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758409|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758410|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758505|NCT01568112|E1|Reported Event|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758412|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758413|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758414|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758415|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758416|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758417|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758418|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758419|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758420|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758421|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758422|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758423|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758424|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758425|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758426|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758427|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758428|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758429|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758430|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758431|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758432|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758433|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758434|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758435|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758436|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758437|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758438|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758439|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758440|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758441|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758442|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758506|NCT01568073|B6|Baseline|Total|Total of all reporting groups
758507|NCT01568073|B5|Baseline|OPC 50mg|OPC, Opicapone 50mg
758443|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758444|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758445|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758446|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758447|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758448|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758449|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758450|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758451|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758452|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758453|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758653|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758454|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758455|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758456|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758457|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758458|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758459|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758460|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758461|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758462|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758463|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758464|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758465|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758466|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758467|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758468|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758469|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758470|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758471|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758472|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758473|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758508|NCT01568073|B4|Baseline|OPC 25mg|OPC, Opicapone 25mg
758509|NCT01568073|B3|Baseline|OPC 5mg|OPC, Opicapone 5mg
758510|NCT01568073|B2|Baseline|Entacapone|Entacapone - 200 mg
758474|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758475|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758476|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758477|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758478|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758479|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758480|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758481|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758482|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758483|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
759549|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
758484|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758485|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758486|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758487|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758488|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758489|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758490|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758491|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758492|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758493|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758494|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg QD during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758495|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758496|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758497|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758498|NCT01568112|O4|Outcome|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758499|NCT01568112|O3|Outcome|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758500|NCT01568112|O2|Outcome|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758501|NCT01568112|O1|Outcome|Placebo|Participants received BG00012 placebo for 8 weeks and premedication with ASA placebo during the first 4 weeks.
758502|NCT01568112|E4|Reported Event|BG00012 Slow Titration|Participants received BG00012 for 8 weeks (120 mg once daily [QD] during Week 1, 120 mg BID during Week 2, 240 mg AM/120mg PM during Week 3, and 240 mg BID during Week 4, and 240 mg BID during Weeks 5 to 8) and premedication with ASA placebo during the first 4 weeks.
758503|NCT01568112|E3|Reported Event|BG00012 + ASA|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA during the first 4 weeks.
758504|NCT01568112|E2|Reported Event|BG00012|Participants received BG00012 for 8 weeks (120 mg BID during the first week and 240 mg BID during the subsequent 7 weeks) and premedication with ASA placebo during the first 4 weeks.
758511|NCT01568073|B1|Baseline|Placebo|Placebo 200 mg
758545|NCT01568047|B2|Baseline|BIA 9-1067 (5 mg)|5 mg BIA 9-1067 - OPC, Opicapone
758546|NCT01568047|B1|Baseline|Placebo|PLC, Placebo
758547|NCT01568047|P4|Participant Flow|BIA 9-1067 (30 mg)|OPC, Opicapone
758548|NCT01568047|P3|Participant Flow|BIA 9-1067 (15 mg)|OPC, Opicapone
758549|NCT01568047|P2|Participant Flow|BIA 9-1067 (5 mg)|OPC, Opicapone
758550|NCT01568047|P1|Participant Flow|Placebo|PLC, Placebo
758551|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
758552|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
758553|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
758554|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
758555|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
758556|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
758557|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
758558|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
758559|NCT01568047|O4|Outcome|BIA 9-1067 30 mg|30 mg BIA 9-1067 - OPC, Opicapone
758560|NCT01568047|O3|Outcome|BIA 9-1067 15 mg|15 mg BIA 9-1067 - OPC, Opicapone
758561|NCT01568047|O2|Outcome|BIA 9-1067 5 mg|5 mg BIA 9-1067 - OPC, Opicapone
758562|NCT01568047|O1|Outcome|Placebo|PLC, Placebo
758563|NCT01568047|E4|Reported Event|BIA 9-1067 (30 mg)|30 mg BIA 9-1067, OPC, Opicapone
758564|NCT01568047|E3|Reported Event|BIA 9-1067 (15 mg)|15 mg BIA 9-1067, OPC, Opicapone
758565|NCT01568047|E2|Reported Event|BIA 9-1067 (5 mg)|5 mg BIA 9-1067, OPC, Opicapone
758566|NCT01568047|E1|Reported Event|Placebo|Placebo, PLC
758610|NCT01567943|O1|Outcome|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
758611|NCT01567943|O2|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
758567|NCT01568034|B1|Baseline|Overall Study|The study was to consist of four consecutive treatment periods, corresponding to the 4 different treatment options (25 mg, 50 mg and 100 mg BIA 9-1067or Placebo).According to randomisation, subjects were to receive, in a double-blind manner, 25, 50 and 100 mg BIA 9-1067 or Placebo at 4 separate treatment periods. Each subject were to receive each of the three BIA 9-1067 doses and Placebo in a random sequence with a 3:1 ratio (BIA 9-1067: Placebo) per treatment period.
758568|NCT01568034|P4|Participant Flow|Treatment Sequence D|"Treatment Sequence D Period 1 - 50 mg BIA 9-1067 Period 2 - 100 mg BIA 9-1067 Period 3 - Placebo Period 4 - 25 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
758569|NCT01568034|P3|Participant Flow|Treatment Sequence C|"Treatment Sequence C Period 1 - 100 mg BIA 9-1067 Period 2 - Placebo Period 3 - 25 mg BIA 9-1067 Period 4 - 50 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
758570|NCT01568034|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B Period 1 - Placebo Period 2 - 25 mg BIA 9-1067 Period 3 - 50 mg BIA 9-1067 Period 4 - 100 mg BIA 9-1067~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
758571|NCT01568034|P1|Participant Flow|Treatment Sequence A|"Period 1 - 25 mg BIA 9-1067 Period 2 - 50 mg BIA 9-1067 Period 3 - 100 mg BIA 9-1067 Period 4 - Placebo~Levodopa/Carbidopa combination were given to half of the volunteers and Levodopa/Benzerazide to the other half"
758572|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
758573|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
758574|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
758575|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
758576|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
758577|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
758578|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
758579|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
758580|NCT01568034|O4|Outcome|BIA 9-1067 100 mg|BIA 9-1067 - OPC, Opicapone
758581|NCT01568034|O3|Outcome|BIA 9-1067 50 mg|BIA 9-1067 - OPC, Opicapone
758582|NCT01568034|O2|Outcome|BIA 9-1067 25 mg|BIA 9-1067 - OPC, Opicapone
758583|NCT01568034|O1|Outcome|Placebo|PLC, Placebo
758584|NCT01568034|E4|Reported Event|Placebo|Placebo ESL, Eslicarbazepine
758585|NCT01568034|E3|Reported Event|100 mg BIA 9-1067|100 mg BIA 9-1067 ESL, Eslicarbazepine
758586|NCT01568034|E2|Reported Event|50 mg BIA 9-1067|50 mg BIA 9-1067 ESL, Eslicarbazepine
758587|NCT01568034|E1|Reported Event|25 mg BIA 9-1067|25 mg BIA 9-1067 ESL, Eslicarbazepine
758588|NCT01568021|B1|Baseline|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
758589|NCT01568021|P1|Participant Flow|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
758590|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
758591|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
758592|NCT01568021|O1|Outcome|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
758593|NCT01568021|E1|Reported Event|OZURDEX®|Single dose of dexamethasone 700 ug intravitreal implant (OZURDEX®) which may be repeated over 1 year as per standard of care in clinical practice. No intervention was administered in this study.
758594|NCT01568008|B1|Baseline|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758595|NCT01568008|P1|Participant Flow|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758596|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758597|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758598|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758599|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758600|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758601|NCT01568008|O1|Outcome|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758602|NCT01568008|E1|Reported Event|All Participants|Lumigan® 0.01% (bimatoprost 0.01% ophthalmic solution) eye drops at a dose and frequency as determined by the physician.
758603|NCT01567943|B3|Baseline|Total|Total of all reporting groups
758604|NCT01567943|B2|Baseline|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
758605|NCT01567943|B1|Baseline|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
758606|NCT01567943|P3|Participant Flow|Pre-randomization Drop-out|These participants were enrolled/consented in the study but not randomized to the Contingency Management or Control conditions.
758607|NCT01567943|P2|Participant Flow|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
758608|NCT01567943|P1|Participant Flow|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
758609|NCT01567943|O2|Outcome|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
801752|NCT01391663|B5|Baseline|Total|Total of all reporting groups
758612|NCT01567943|O1|Outcome|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
758613|NCT01567943|E2|Reported Event|Non-contingent Control Group|Treatment as usual plus reinforcement for attendance
758614|NCT01567943|E1|Reported Event|Contingency Management|"Contingency Management plus treatment as usual~Contingency Management: Behavioral reinforcement for alcohol abstinence"
758615|NCT01567852|B3|Baseline|Total|Total of all reporting groups
758616|NCT01567852|B2|Baseline|Methohexital First|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital.~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
758617|NCT01567852|B1|Baseline|Ketamine First|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction"
758618|NCT01567852|P2|Participant Flow|Methohexital Then Ketamine (Alternating Each Trial)|"This arm will receive Methohexital first for induction, followed by alternating treatments between ketamine and methohexital. Each induction is one trial. Each trial is followed by one day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
758619|NCT01567852|P1|Participant Flow|Ketamine Then Methohexital (Alternating Each Trial)|"This arm will receive ketamine for induction first, followed by alternating treatments between methohexital and ketamine. Each induction is counted as one trial. Each trial is followed by a day of no treatment (2 days for weekends).~Ketamine: Ketamine (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect~Methohexital: Methohexital (1-1.5mg/kg) will be given for induction, with room to titrate up to induction effect"
758620|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
758621|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
758622|NCT01567852|O2|Outcome|Methohexital Inductions|Patients receiving methohexital for inductions
758623|NCT01567852|O1|Outcome|Ketamine Inductions|Patients receiving Ketamine inductions for ECT
758624|NCT01567852|E2|Reported Event|Methohexital Inductions|Number of trials receiving methohexital inductions. Each trial is one induction
758625|NCT01567852|E1|Reported Event|Ketamine Inductions|Number of trials receiving ketamine inductions. Each trial is one induction.
758626|NCT01567839|B1|Baseline|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
758627|NCT01567839|P1|Participant Flow|Subjects Receiving Injections|All subjects received each of the three anesthetic injections.
758628|NCT01567839|O3|Outcome|4% Prilocaine With 1:200,000 Epinephrine|
758629|NCT01567839|O2|Outcome|4% Lidocaine With 1:100,000 Epinephrine|
758630|NCT01567839|O1|Outcome|4% Articaine With 1:100,000 Epinephrine|
758631|NCT01567839|E3|Reported Event|4% Prilocaine With 1:200,000 Epinephrine|
758632|NCT01567839|E2|Reported Event|4% Lidocaine With 1:100,000 Epinephrine|
758633|NCT01567839|E1|Reported Event|4% Articaine With 1:100,000 Epinephrine|
758634|NCT01567826|B3|Baseline|Total|Total of all reporting groups
758635|NCT01567826|B2|Baseline|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
758636|NCT01567826|B1|Baseline|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
758637|NCT01567826|P2|Participant Flow|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
758835|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758836|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758638|NCT01567826|P1|Participant Flow|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
758639|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758640|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758641|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758642|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758643|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758644|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758645|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758646|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758647|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758648|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758649|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
758650|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
758651|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758654|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758655|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
758656|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
758657|NCT01567826|O2|Outcome|Aggressive Lipid Therapy|"aggressive lipid therapy: Crestor~Aggressive lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy."
758658|NCT01567826|O1|Outcome|Standard of Care Lipid Therapy|"standard-care lipid-lowering therapy: Zocor or Lipitor~standard of care lipid therapy: Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
758659|NCT01567826|E2|Reported Event|Aggressive Lipid Therapy|aggressive lipid therapy: Crestor
758660|NCT01567826|E1|Reported Event|Standard of Care Lipid Therapy|standard-care lipid-lowering therapy: Zocor or Lipitor
758661|NCT01567371|B1|Baseline|LiDCO Rapid Monitor|
758662|NCT01567371|P1|Participant Flow|LiDCO Rapid Monitor|
758663|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
758664|NCT01567371|O1|Outcome|LiDCO Rapid Monitor|
758665|NCT01567371|E1|Reported Event|LiDCO Rapid Monitor|
758666|NCT01567163|B1|Baseline|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
758667|NCT01567163|P1|Participant Flow|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
758668|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
758669|NCT01567163|O1|Outcome|Ramucirumab|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
758670|NCT01567163|O1|Outcome|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
758671|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
758672|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
758673|NCT01567163|O1|Outcome|Docetaxel (Cycle 2)|Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion and followed by docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
758674|NCT01567163|O1|Outcome|Docetaxel (Cycle 1)|Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle
758709|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow and 54 patients were included in final analysis."
758675|NCT01567163|E1|Reported Event|All Participants|"Cycle 1: docetaxel 75-milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of 3-week cycle~Cycle 2: ramucirumab 10-milligrams/kilogram (mg/kg) intravenous infusion, followed by docetaxel 75-mg/m^2 intravenous infusion administered on Day 1 of 3-week cycle~Cycle 3 and beyond: ramucirumab and docetaxel administered on Day 1 of each 3-week cycle"
758676|NCT01567150|B3|Baseline|Total|Total of all reporting groups
758677|NCT01567150|B2|Baseline|Control|Control is treatment without novel dressing
758678|NCT01567150|B1|Baseline|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
758679|NCT01567150|P2|Participant Flow|Control|Control is treatment without novel dressing
758680|NCT01567150|P1|Participant Flow|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
758681|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
758682|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
758683|NCT01567150|O2|Outcome|Control|Control is treatment without novel dressing
758684|NCT01567150|O1|Outcome|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
758685|NCT01567150|E2|Reported Event|Control|Control is treatment without novel dressing
758686|NCT01567150|E1|Reported Event|Novel Dressing|"Treatment with novel dressing~Novel Dressing: Topical wound dressing"
758687|NCT01567020|B5|Baseline|Total|Total of all reporting groups
758688|NCT01567020|B4|Baseline|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758689|NCT01567020|B3|Baseline|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758690|NCT01567020|B2|Baseline|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
802029|NCT01390844|B5|Baseline|Total|Total of all reporting groups
758691|NCT01567020|B1|Baseline|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758692|NCT01567020|P4|Participant Flow|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758693|NCT01567020|P3|Participant Flow|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758694|NCT01567020|P2|Participant Flow|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758695|NCT01567020|P1|Participant Flow|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758696|NCT01567020|O4|Outcome|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758697|NCT01567020|O3|Outcome|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758698|NCT01567020|O2|Outcome|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758699|NCT01567020|O1|Outcome|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758700|NCT01567020|E4|Reported Event|Older|"Non-blast-exposed and non-TBI, aged 50 or older~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758701|NCT01567020|E3|Reported Event|Non-Blast-Exposed TBI|"Non-blast-exposed with TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758702|NCT01567020|E2|Reported Event|Blast|"Blast-exposed with or without a TBI diagnosis~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758703|NCT01567020|E1|Reported Event|Control|"Non-blast-exposed and non-TBI, aged younger than 50~Diagnostic: All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities."
758704|NCT01566981|B3|Baseline|Total|Total of all reporting groups
758705|NCT01566981|B2|Baseline|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
758706|NCT01566981|B1|Baseline|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
758707|NCT01566981|P2|Participant Flow|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up, so 54 patients were included in final analysis."
758708|NCT01566981|P1|Participant Flow|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
758710|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
758711|NCT01566981|O2|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with Diabetes mellitus (DM) type II, who will get the software application and web- based support Intervention: Computerized support to the Diabetes type II patients~Computerized support to the Diabetes type II patients: The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process."
758712|NCT01566981|O1|Outcome|Diabetes Without Support|The group of randomly selected patients with DM type II, without software application and web-based support.
758713|NCT01566981|O2|Outcome|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow and 54 patients were included in final analysis."
758714|NCT01566981|O1|Outcome|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up, consequently 53 patients were included in final analysis"
758715|NCT01566981|E2|Reported Event|Diabetes Without Support|"62 randomly selected patients with DM type II that were followed by using usual healthcare - without software application and web-based support.~8 patients were lost to follow up and 12 patients missed final consultation. 54 patients were included in final analysis."
759038|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
758716|NCT01566981|E1|Reported Event|Diabetes With ICT Support (E-diabetes)|"The group of randomly selected patients with DM type II, who will get the software application and web- based support Intervention: Computerised support to the Diabetes type II patients~Computerised support to the Diabetes type II patients: 58 randomly selected patients with diabetes type II got software application and web based support to their usual healthcare process.~5 patients were lost to follow up and 13 patients missed final consultation, consequently 53 patients were included in final analysis"
758717|NCT01566838|B3|Baseline|Total|Total of all reporting groups
758718|NCT01566838|B2|Baseline|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758719|NCT01566838|B1|Baseline|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758720|NCT01566838|P2|Participant Flow|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758721|NCT01566838|P1|Participant Flow|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Three patients did not have follow-up data for the study and were therefore excluded from analysis~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758739|NCT01566721|P2|Participant Flow|Cohort B: SC Herceptin by Single-Use Injection Device (SID)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by a healthcare professional (HCP). Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758837|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
761723|NCT01553318|E2|Reported Event|Placebo|received placebo
758722|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758723|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758747|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
759039|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
758724|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758725|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758726|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758727|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758728|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758740|NCT01566721|P1|Participant Flow|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 milligrams (mg) every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758741|NCT01566721|O1|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
766551|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
758729|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758730|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758731|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758732|NCT01566838|O2|Outcome|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758733|NCT01566838|O1|Outcome|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758734|NCT01566838|E2|Reported Event|Standard of Care|"Patients in this arm will not receive a pain catheter in addition to the standard of care for pain management. Standard of care will consist of a standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and maintained on a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures. Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV once, neuromuscular reversal agents, and an antiemetic (ondansetron 4mg). Patients will be given additional narcotics (fentanyl) upon emergence, as needed, to facilitate patient comfort and extubation.~The ASA guidelines for acute pain management in the perioperative period will also be provided. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3.~Standard acute pain management"
758735|NCT01566838|E1|Reported Event|On-q Pump|"Patients in this arm will receive the standard acute pain management regimen during hospital admission and will be sent home after discharge with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.~Subpleural pain catheter with infusion of 0.125% bupivacaine: Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days."
758736|NCT01566721|B3|Baseline|Total|Total of all reporting groups
758737|NCT01566721|B2|Baseline|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758738|NCT01566721|B1|Baseline|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758838|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758742|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758743|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758744|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758745|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758746|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
759040|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
758748|NCT01566721|O3|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
758749|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758750|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758751|NCT01566721|O3|Outcome|Cohort B: SC Herceptin by SID (Self-Administered)|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
758752|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758753|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758754|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758755|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758756|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758757|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758758|NCT01566721|O2|Outcome|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758759|NCT01566721|O1|Outcome|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758760|NCT01566721|E2|Reported Event|Cohort B: SC Herceptin by SID|Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
758761|NCT01566721|E1|Reported Event|Cohort A: SC Herceptin by Needle/Syringe|Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
758762|NCT01566630|B3|Baseline|Total|Total of all reporting groups
758763|NCT01566630|B2|Baseline|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
758764|NCT01566630|B1|Baseline|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
766552|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
758765|NCT01566630|P2|Participant Flow|Placebo|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. The randomized patient received matching placebo of serelaxin (RLX030) in a blinded manner.
758766|NCT01566630|P1|Participant Flow|RLX030|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. As per planned treatment assigned, patients in this arm received open label serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours.
758767|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758768|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758769|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758770|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758771|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758851|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758772|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758773|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758774|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758775|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758776|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758777|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758778|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758779|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758780|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758781|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758782|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758783|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758784|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758785|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758786|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758787|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758788|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758789|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758790|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758791|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758792|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758793|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758794|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758795|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758796|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758797|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758798|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758799|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758800|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758801|NCT01566630|O2|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758802|NCT01566630|O1|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758803|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758804|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758805|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758806|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758807|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758808|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758809|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758810|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758811|NCT01566630|O4|Outcome|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758812|NCT01566630|O3|Outcome|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758813|NCT01566630|O2|Outcome|Placebo - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758814|NCT01566630|O1|Outcome|RLX030 - Maternal|Because premature termination of the study, only Cohort 1 part 1 had patients with early onset pre-eclampsia. Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758815|NCT01566630|E4|Reported Event|Placebo- Neonates Born to Patients|Neonates born to patients who received placebo for 72 hours received by pregnant patients with early onset pre-eclampsia
758816|NCT01566630|E3|Reported Event|Placebo- Maternal|Matching placebo to serelaxin (RLX030) received for 72 hours by pregnant patients with early onset pre-eclampsia
758817|NCT01566630|E2|Reported Event|RLX030- Neonates Born to Patients|Neonates born to patients who received Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received
758818|NCT01566630|E1|Reported Event|RLX030- Maternal|Serelaxin (RLX030) 15 μg/kg/day i.v. for 72 hours received by pregnant patients with early onset pre-eclampsia
758819|NCT01566604|B3|Baseline|Total|Total of all reporting groups
758820|NCT01566604|B2|Baseline|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758821|NCT01566604|B1|Baseline|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758822|NCT01566604|P2|Participant Flow|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758823|NCT01566604|P1|Participant Flow|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758824|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758825|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758826|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758827|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758828|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758829|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758830|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758831|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758832|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758833|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758834|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
766553|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
758839|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758840|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758841|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758842|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758843|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758844|NCT01566604|O2|Outcome|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758845|NCT01566604|O1|Outcome|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758846|NCT01566604|E2|Reported Event|Placebo|Placebo once daily delivered via a single dose dry powder inhaler
758847|NCT01566604|E1|Reported Event|NVA237|NVA237 50 µg once daily delivered via a single dose dry powder inhaler
758848|NCT01566526|B1|Baseline|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758849|NCT01566526|P1|Participant Flow|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758850|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758852|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758853|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758854|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758855|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758856|NCT01566526|O1|Outcome|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758857|NCT01566526|E1|Reported Event|Patients Previously Treated With OZURDEX®|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
758858|NCT01566500|B1|Baseline|Study Sample|Adults with self-reported epilepsy.
758859|NCT01566500|P1|Participant Flow|Study Sample|Adults with self-reported epilepsy.
758860|NCT01566500|O1|Outcome|Study Sample|Adults with self-reported epilepsy.
758861|NCT01566500|E1|Reported Event|Study Sample|Adults with self-reported epilepsy.
758862|NCT01566461|B3|Baseline|Total|Total of all reporting groups
758863|NCT01566461|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
758864|NCT01566461|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
758865|NCT01566461|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
758866|NCT01566461|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
758867|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758868|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758869|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758870|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758871|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758872|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758873|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758874|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758875|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
759029|NCT01565980|O1|Outcome|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
766554|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
758876|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758877|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758878|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758879|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758880|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758881|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758882|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
759041|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
758883|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758884|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758885|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758886|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758887|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758888|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758889|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758890|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758891|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758892|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758893|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758894|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758895|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758896|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758897|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758898|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758899|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758900|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758901|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758902|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758903|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
766555|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
758904|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758905|NCT01566461|O2|Outcome|Standard PTA|"Standard PTA Balloon: Balloon Angioplasty~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758906|NCT01566461|O1|Outcome|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~IN.PACT Admiral Drug-Coated Balloon (DCB): Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm"
758907|NCT01566461|E2|Reported Event|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
758908|NCT01566461|E1|Reported Event|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
758931|NCT01566409|E1|Reported Event|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
758932|NCT01566370|B3|Baseline|Total|Total of all reporting groups
758909|NCT01566435|B1|Baseline|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758910|NCT01566435|P1|Participant Flow|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m^2 IV week for 8 weeks"
758911|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758912|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758913|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758914|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758928|NCT01566409|O2|Outcome|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
759415|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
758915|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758933|NCT01566370|B2|Baseline|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
759178|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
758916|NCT01566435|O1|Outcome|Arm 1-ACF Induction Therapy Followed by Chemoradiation Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758917|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758918|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758919|NCT01566435|O1|Outcome|Arm 1 (ACF)|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m2 on Days 1, 8, and 15~Cisplatin 75 mg/m2 on Day 1~5-FU 750 mg/m2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF.~Definitive Therapy~Cisplatin 100 mg/m2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions.~If patient cannot receive cisplatin then he/she will receive cetuximab 250 mg/m2 IV week for 8 weeks"
758920|NCT01566435|E3|Reported Event|ACF Definitive Chemoradiation Therapy-cetuximab|"Definitive Therapy~Cetuximab 250 mg/m^2 IV weekly for 8 weeks~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
758921|NCT01566435|E2|Reported Event|ACF Definitive Chemoradiation Therapy-cisplatin|"Definitive Therapy~Cisplatin 100 mg/m^2 IV on Days 1, 22, and 43~Intensity modulated radiation therapy (IMRT) 7000 cGy in 35 fractions of 200 cGy each over 7 weeks. A dose of 6300 cGy in 35 fractions is optional and may be delivered to area considered to be at intermediate risk. Additional regions in the ipsilateral and contralateral neck at risk for microscopic disease in the cervical lymph nodes will receive 5600 cGy in 35 fractions."
758922|NCT01566435|E1|Reported Event|ACF Induction Therapy|"ACF Induction Therapy (Cycle 1 and Cycle 2 - each cycle is every 3 weeks)~nab-Paclitaxel 100 mg/m^2 on Days 1, 8, and 15~Cisplatin 75 mg/m^2 on Day 1~5-FU 750 mg/m^2 on Days 1-3~If patient has complete or partial response, he/she will receive an additional ACF cycle (cycle 3). If patient has stable disease or progressive disease will not receive the third cycle of ACF."
758923|NCT01566409|B3|Baseline|Total|Total of all reporting groups
758924|NCT01566409|B2|Baseline|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
758925|NCT01566409|B1|Baseline|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
758926|NCT01566409|P2|Participant Flow|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
758927|NCT01566409|P1|Participant Flow|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
758929|NCT01566409|O1|Outcome|Active Maintenance Treatment|Polyethylene glycol 3350: Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
758930|NCT01566409|E2|Reported Event|Placebo Maintenance Treatment|Placebo: Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
759034|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
758934|NCT01566370|B1|Baseline|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758935|NCT01566370|P2|Participant Flow|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758936|NCT01566370|P1|Participant Flow|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758937|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758938|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758939|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758940|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758941|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758942|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758943|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758944|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758945|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758946|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758947|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758948|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758949|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758950|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758951|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758952|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758953|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758954|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758955|NCT01566370|O2|Outcome|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758956|NCT01566370|O1|Outcome|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758957|NCT01566370|E2|Reported Event|Placebo|"Patients will receive placebo pills that are made to match the zonisamide medication (via over-encapsulation, double-blind, subjects will receive same number of capsules as the active medication group~Placebo: placebo"
758958|NCT01566370|E1|Reported Event|Zonisamide|"Subjects will receive zonisamide titrated to a target dose of 500mg orally, daily, double-blind~Zonisamide: titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose"
758959|NCT01566331|B3|Baseline|Total|Total of all reporting groups
758960|NCT01566331|B2|Baseline|Baby-guardTM With Minimal Inflation|Baby-guardTM system, with minimal inflation in women who expected natural delivery
758961|NCT01566331|B1|Baseline|Baby-guardTM|Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
758962|NCT01566331|P2|Participant Flow|Baby-guardTM Minimal Inflation|Baby-guardTM with minimal inflation who expected natural delivery
759035|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
758963|NCT01566331|P1|Participant Flow|Baby-guardTM|"Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes~Baby-guardTM: Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes"
758964|NCT01566331|O2|Outcome|Baby-guardTM With Minimal Inflation|
758965|NCT01566331|O1|Outcome|Baby Belt Device Group|
758966|NCT01566331|E2|Reported Event|Baby Birth With Minimal Inflation|group delivering with dwvice and minimal inflation
758967|NCT01566331|E1|Reported Event|Baby Birth|group delivering with baby birth
758968|NCT01566162|B1|Baseline|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758969|NCT01566162|P1|Participant Flow|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758970|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758971|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758972|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758973|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758974|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758975|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758976|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758977|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758978|NCT01566162|O1|Outcome|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758979|NCT01566162|E1|Reported Event|Lurasidone|"Lurasidone 40 – 80mg flexible dose~Lurasidone: Lurasidone 40-80 mg taken orally taken once daily"
758980|NCT01566149|B3|Baseline|Total|Total of all reporting groups
758981|NCT01566149|B2|Baseline|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758982|NCT01566149|B1|Baseline|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758983|NCT01566149|P2|Participant Flow|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758984|NCT01566149|P1|Participant Flow|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758985|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758986|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758987|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758988|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758989|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758990|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758991|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758992|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758993|NCT01566149|O2|Outcome|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758994|NCT01566149|O1|Outcome|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758995|NCT01566149|E2|Reported Event|MF/F 400/10 mcg MDI BID|Participants receiving MF/F 400/10 mcg MDI BID for 12 weeks
758996|NCT01566149|E1|Reported Event|MF/F 200/10 mcg MDI BID|Participants receiving MF/F 200/10 mcg MDI BID for 12 weeks
758997|NCT01566084|B3|Baseline|Total|Total of all reporting groups
758998|NCT01566084|B2|Baseline|Placebo (Start)|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the slow sodium tablet arm in the second half of the study."
758999|NCT01566084|B1|Baseline|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a slow sodium tablets to bring them back up to a normal salt intake. This is administered through 10 tablets day.~Subjects then cross-over to the placebo arm in the second half of the study."
759000|NCT01566084|P2|Participant Flow|Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~Subjects then cross over to the opposite condition in the second half of the study."
759001|NCT01566084|P1|Participant Flow|Slow Sodium Tablets (Start)|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~Subjects then cross over to the opposite condition in the second half of the study."
759002|NCT01566084|O4|Outcome|Low Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
759003|NCT01566084|O3|Outcome|Normal Sodium BH4|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
759036|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
803895|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
759004|NCT01566084|O2|Outcome|Low Sodium Placebo|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
759005|NCT01566084|O1|Outcome|Normal Sodium Placebo|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following acute oral tetrahydrobiopterin (BH4) or placebo is measured at the end of 5 weeks of sodium condition (low and normal intake) as an index of BH4 bioavailability."
759006|NCT01566084|O4|Outcome|Low Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
759007|NCT01566084|O3|Outcome|Normal Sodium Ascorbic Acid|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
759008|NCT01566084|O2|Outcome|Low Sodium Saline|"Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
759009|NCT01566084|O1|Outcome|Normal Sodium Saline|"Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.~FMD is assessed following an acute supraphysiological infusion of ascorbic acid (known to scavenge superoxide) compared to an equal volume of normal saline."
759010|NCT01566084|O2|Outcome|Low Sodium Diet.|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
759011|NCT01566084|O1|Outcome|Normal Sodium Diet|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of a salt pill to bring them back up to a normal salt intake.
759012|NCT01566084|E2|Reported Event|Low Sodium|Subjects on a 1200 mg salt diet are given placebo pills in order to maintain them on a low salt diet.
759013|NCT01566084|E1|Reported Event|Normal Sodium|Subjects on a 1200 mg sodium diet are given 2300 mg sodium in the form of slow sodium tablets to bring them back up to a normal salt intake.
759014|NCT01565993|B3|Baseline|Total|Total of all reporting groups
759015|NCT01565993|B2|Baseline|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
759016|NCT01565993|B1|Baseline|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
759017|NCT01565993|P2|Participant Flow|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
759018|NCT01565993|P1|Participant Flow|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
759019|NCT01565993|O2|Outcome|Conventional Polipectomy|In group CONVENTIONAL POLYPECTOMY, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique.Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection.
759020|NCT01565993|O1|Outcome|Hemoclip|"In group HEMOCLIP, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop. In all the polypectomies that were assigned to group HEMOCLIP, a rotatable clip-fixing device Quickclip 2 standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm"
759021|NCT01565993|E2|Reported Event|Group B: Conventional Polipectomy|In group B, a conventional polypectomy was performed, which was not aided beforehand by any other hemostatic technique
759022|NCT01565993|E1|Reported Event|Group A: Hemoclips|In group A, one or more clips were placed (based on the criteria of the endoscopist in accordance with the size of the pedicle), and the polyp was subsequently resected using a diathermy loop
759023|NCT01565980|B3|Baseline|Total|Total of all reporting groups
759024|NCT01565980|B2|Baseline|Mindfulness Intervention|"Participants receive weekly symptom assessment phone calls.~Mindfulness Intervention: Participants receive 6 weekly sessions of a home delivered mindfulness intervention."
759025|NCT01565980|B1|Baseline|Attention Control|weekly symptom assessment phone calls.
759026|NCT01565980|P2|Participant Flow|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
759027|NCT01565980|P1|Participant Flow|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
759028|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention.~Participants also receive weekly symptom assessment phone interview."
766556|NCT01530334|E1|Reported Event|Gefitinib|250 mg/die, oral
759030|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weeks of the home-based mindfulness intervention, and weekly symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks."
759031|NCT01565980|O1|Outcome|Symptom Assessment|"6 weeks of symptom assessment phone calls.~symptom assessment: attention control receives a weekly symptom assessment phone interview for 6 weeks."
759032|NCT01565980|O2|Outcome|Mindfulness Intervention|"Participants receive 6 weekly sessions of a home delivered mindfulness intervention.~Participants receive weekly phone calls to assess symptoms."
759033|NCT01565980|O1|Outcome|Attention Control Group|"weekly phone calls.~symptom assessment interview."
804167|NCT01381016|B3|Baseline|Total|Total of all reporting groups
759042|NCT01565980|E2|Reported Event|Mindfulness Intervention|"Participants will receive 6 weeks of home-based mindfulness intervention.~Mindfulness Intervention: Participants will receive a weekly home-based mindfulness intervention."
759043|NCT01565980|E1|Reported Event|Symptom Assessment|"weekly phone calls.~symptom assessment: attention control group"
759044|NCT01565902|B5|Baseline|Total|Total of all reporting groups
759045|NCT01565902|B4|Baseline|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
759046|NCT01565902|B3|Baseline|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759047|NCT01565902|B2|Baseline|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759048|NCT01565902|B1|Baseline|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759049|NCT01565902|P4|Participant Flow|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
759050|NCT01565902|P3|Participant Flow|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759051|NCT01565902|P2|Participant Flow|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759052|NCT01565902|P1|Participant Flow|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759053|NCT01565902|O4|Outcome|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
759054|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759055|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759056|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759057|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
759058|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
759059|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
759060|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759061|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759062|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759063|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
759064|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
759065|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
759066|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759067|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759068|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759069|NCT01565902|O6|Outcome|Matched Healthy Subjects - Severe|Treatment with a single oral dose of 0.25 mg BAF312
759070|NCT01565902|O5|Outcome|Matched Healthy Subjects - Moderate|Treatment with a single oral dose of 0.25 mg BAF312
759071|NCT01565902|O4|Outcome|Matched Healthy Subjects – Mild|Treatment with a single oral dose of 0.25 mg BAF312
759072|NCT01565902|O3|Outcome|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759073|NCT01565902|O2|Outcome|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759074|NCT01565902|O1|Outcome|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759075|NCT01565902|E4|Reported Event|Mild Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759076|NCT01565902|E3|Reported Event|Matched Healthy Subjects|Treatment with a single oral dose of 0.25 mg BAF312
759077|NCT01565902|E2|Reported Event|Severe Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759078|NCT01565902|E1|Reported Event|Moderate Hepatically Impaired|Treatment with a single oral dose of 0.25 mg BAF312
759079|NCT01565889|B7|Baseline|Total|Total of all reporting groups
759133|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759080|NCT01565889|B6|Baseline|Part B: SOF+PEG+RBV|"SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.~This reporting group presents data for those participants who joined the study for Part B only."
759081|NCT01565889|B5|Baseline|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
759082|NCT01565889|B4|Baseline|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759083|NCT01565889|B3|Baseline|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759084|NCT01565889|B2|Baseline|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
759085|NCT01565889|B1|Baseline|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
759086|NCT01565889|P6|Participant Flow|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + pegylated interferon alpha (PEG) 180 μg subcutaneous injection once weekly + weight-based ribavirin (RBV; 1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759087|NCT01565889|P5|Participant Flow|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + raltegravir (RAL) 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
759088|NCT01565889|P4|Participant Flow|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + darunavir (DRV; 800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759089|NCT01565889|P3|Participant Flow|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + atazanavir (ATV) 400 mg tablet boosted with ritonavir (RTV) 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759090|NCT01565889|P2|Participant Flow|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
759091|NCT01565889|P1|Participant Flow|Part A: SOF+EFV/FTC/TDF (Cohort 1)|Sofosbuvir (SOF; 1 × 400 mg tablet or 2 × 200 mg tablets) + efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
759092|NCT01565889|O6|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759093|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
759094|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759095|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759096|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
759097|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
759098|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759099|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759100|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759101|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759102|NCT01565889|O1|Outcome|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759103|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
766557|NCT01530243|B5|Baseline|Total|Total of all reporting groups
759104|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759105|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759106|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
759107|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
759108|NCT01565889|O5|Outcome|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
759109|NCT01565889|O4|Outcome|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759179|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
759110|NCT01565889|O3|Outcome|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759111|NCT01565889|O2|Outcome|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
759112|NCT01565889|O1|Outcome|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
759113|NCT01565889|E6|Reported Event|Part B: SOF+PEG+RBV|SOF 400 mg tablet once daily + PEG 180 μg subcutaneous injection once weekly + weight-based RBV (1000-1200 mg as 200 mg tablets in a divided daily dose) for 12 weeks.
759114|NCT01565889|E5|Reported Event|Part A: SOF+RAL+FTC/TDF (Cohort 5)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + RAL 400 mg tablet twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days followed by RAL 400 mg twice daily + FTC/TDF (200/300 mg) tablet once daily for 7 days.
759115|NCT01565889|E4|Reported Event|Part A: SOF+RTV+DRV+FTC/TDF (Cohort 4)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + DRV (800 mg; 2 × 400 mg tablets) boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by DRV (800 mg; 2 x 400 mg tablets) + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759116|NCT01565889|E3|Reported Event|Part A: SOF+RTV+ATV+FTC/TDF (Cohort 3)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + ATV 400 mg tablet boosted with RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days followed by ATV 400 mg tablet + RTV 100 mg tablet + FTC/TDF (200/300 mg) tablet coadministered once daily for 7 days.
759117|NCT01565889|E2|Reported Event|Part A: SOF+EFV+ZDV/3TC (Cohort 2)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) once daily + EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days followed by EFV 600 mg tablet once daily + ZDV/3TC (300/150 mg) tablet twice daily for 7 days.
759118|NCT01565889|E1|Reported Event|Part A: SOF+EFV/FTC/TDF (Cohort 1)|SOF (1 × 400 mg tablet or 2 × 200 mg tablets) + EFV/FTC/TDF (600/200/300 mg) tablet coadministered once daily for 7 days followed by EFV/FTC/TDF (600/200/300 mg) tablet once daily for 7 days.
759119|NCT01565850|B3|Baseline|Total|Total of all reporting groups
759120|NCT01565850|B2|Baseline|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759121|NCT01565850|B1|Baseline|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759122|NCT01565850|P2|Participant Flow|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759123|NCT01565850|P1|Participant Flow|D/C/F/TAF|Darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) (800/150/200/10 mg) fixed-dose combination (FDC) tablet plus darunavir (DRV) placebo plus cobicistat (COBI) placebo plus emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) placebo once daily
759124|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759125|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759126|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759127|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759128|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759129|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759130|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759131|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759132|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759531|NCT01564459|E3|Reported Event|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
759134|NCT01565850|O2|Outcome|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759135|NCT01565850|O1|Outcome|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759136|NCT01565850|E2|Reported Event|DRV+COBI+FTC/TDF|DRV 800 mg tablet plus COBI 150 mg tablet plus FTC/TDF 200/300 mg FDC tablet plus D/C/F/TAF placebo once daily
759137|NCT01565850|E1|Reported Event|D/C/F/TAF|D/C/F/TAF (800/150/200/10 mg) FDC tablet plus DRV placebo plus COBI placebo plus FTC/TDF placebo once daily
759138|NCT01565707|B5|Baseline|Total|Total of all reporting groups
759139|NCT01565707|B4|Baseline|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759140|NCT01565707|B3|Baseline|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759141|NCT01565707|B2|Baseline|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759142|NCT01565707|B1|Baseline|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759271|NCT01565382|P1|Participant Flow|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
759143|NCT01565707|P4|Participant Flow|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759144|NCT01565707|P3|Participant Flow|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759145|NCT01565707|P2|Participant Flow|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759146|NCT01565707|P1|Participant Flow|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759147|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759148|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759149|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759150|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759151|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759152|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759153|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759154|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759155|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759156|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759157|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759158|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759159|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
759160|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759161|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759162|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759163|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759164|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
759165|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759166|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759167|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759168|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759169|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
759170|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759171|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759172|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759173|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759174|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
759175|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759176|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759177|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759180|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759181|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759182|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759183|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759184|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
759185|NCT01565707|O5|Outcome|Adolescents PED 10|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759186|NCT01565707|O4|Outcome|Children PED 10|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 10 mg solifenacin succinate suspension
759187|NCT01565707|O3|Outcome|Adolescents PED 7.5|Adolescents aged 12 to 17 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759188|NCT01565707|O2|Outcome|Children PED 7.5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 7.5 mg solifenacin succinate suspension
759189|NCT01565707|O1|Outcome|Children PED 5|Children aged 5 to 11 years of age who received Pediatric Equivalent Dose (PED) 5.0 mg solifenacin succinate suspension
759190|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759191|NCT01565707|O1|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759192|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759193|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759194|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759195|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759196|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759197|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759198|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759199|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759200|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759201|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759258|NCT01565538|B1|Baseline|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
767240|NCT01526538|B3|Baseline|Total|Total of all reporting groups
759202|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759203|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759204|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759205|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759206|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759207|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759208|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759209|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759210|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759211|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759212|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759213|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759214|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759215|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759216|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759217|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759218|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759219|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759220|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759221|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759222|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759223|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759224|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759225|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759226|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759227|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759228|NCT01565707|O4|Outcome|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759229|NCT01565707|O3|Outcome|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo suspension once a day for 12 weeks.
759230|NCT01565707|O2|Outcome|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks. The initial dose started with pediatric equivalent dose (PED) of 5 mg (PED5) based on weight and was titrated up or down to reach the optimal dose. The minimum dose was PED2.5, and the maximum dose was PED10.
759231|NCT01565707|O1|Outcome|Placebo Children|Children aged 5 to 11 years received matching placebo suspension once a day for 12 weeks.
759232|NCT01565707|E4|Reported Event|Solifenacin Succinate Suspension Adolescents|Adolescents aged 12 to 17 years received solifenacin succinate suspension once a day for 12 weeks.
759233|NCT01565707|E3|Reported Event|Placebo Adolescents|Adolescents aged 12 to 17 years received matching placebo oral suspension once a day for 12 weeks.
759234|NCT01565707|E2|Reported Event|Solifenacin Succinate Suspension Children|Children aged 5 to 11 years received solifenacin succinate suspension once a day for 12 weeks.
759235|NCT01565707|E1|Reported Event|Placebo Children|Children aged 5 to 11 years received matching placebo oral suspension once a day for 12 weeks.
759236|NCT01565564|B3|Baseline|Total|Total of all reporting groups
759237|NCT01565564|B2|Baseline|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759238|NCT01565564|B1|Baseline|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759550|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
759239|NCT01565564|P2|Participant Flow|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759240|NCT01565564|P1|Participant Flow|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759241|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759242|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759243|NCT01565564|O2|Outcome|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759244|NCT01565564|O1|Outcome|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759245|NCT01565564|E2|Reported Event|The Usual Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759246|NCT01565564|E1|Reported Event|The Shared Care Arm|"Shared glycaemic control care within the local three-tier's antenatal care network: ·Individualized dietary and physical activity consultation plus group diabetes education~Self blood glucose monitoring~Insulin therapy if indicated~Self blood glucose monitoring~Insulin therapy institutions if indicated;"
759247|NCT01565551|B3|Baseline|Total|Total of all reporting groups
759248|NCT01565551|B2|Baseline|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
759249|NCT01565551|B1|Baseline|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
759250|NCT01565551|P2|Participant Flow|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
759251|NCT01565551|P1|Participant Flow|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
759252|NCT01565551|O2|Outcome|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
759253|NCT01565551|O1|Outcome|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
759254|NCT01565551|E2|Reported Event|Late-Presenting TBI: Rehabilitation Center|"This cohort of patients are studied after presentation to the TRACK-TBI rehabilitation site (MSMC).~N/A (Observational Study): No Interventions: Observational Study"
759255|NCT01565551|E1|Reported Event|Early-Presenting TBI: Acute Sites|"This cohort of patients are studied after acute presentation within 24 hours of TBI to one of the three TRACK-TBI acute Level I Trauma Centers (SFGH, UPMC, UMCB).~N/A (Observational Study): No Interventions: Observational Study"
759256|NCT01565538|B3|Baseline|Total|Total of all reporting groups
759257|NCT01565538|B2|Baseline|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
759259|NCT01565538|P2|Participant Flow|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
759260|NCT01565538|P1|Participant Flow|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
759261|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
759262|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
759263|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
759264|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
759265|NCT01565538|O2|Outcome|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
759266|NCT01565538|O1|Outcome|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
759267|NCT01565538|E2|Reported Event|Pemetrexed|"Pemetrexed at the dose of 500mg/m2 IV infusion every 3 weeks until progression.~Pemetrexed: 500mg/m2 Given IV"
759268|NCT01565538|E1|Reported Event|Erlotinib|"Erlotinib at the dose of 150 mg orally once a day continually until progression.~Erlotinib: 150 mg Given orally"
759269|NCT01565382|B1|Baseline|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
759270|NCT01565382|P2|Participant Flow|Physicians|Private nuclear medicine physicians with no previous training in reading florbetapir scans.
813192|NCT01349829|E4|Reported Event|Havrix - Second Vaccination|
759272|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
759273|NCT01565382|O1|Outcome|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05(NCT00702143)
759274|NCT01565382|E1|Reported Event|A05 Florbetapir-PET Scans|Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143)
759275|NCT01565369|B1|Baseline|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
759276|NCT01565369|P1|Participant Flow|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
759277|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
759278|NCT01565369|O1|Outcome|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
759279|NCT01565369|O1|Outcome|All A07(NCT00857415) Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07(NCT00857415)
759280|NCT01565369|E1|Reported Event|All A07 Autopsy Subjects|Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07
759281|NCT01565356|B1|Baseline|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
759282|NCT01565356|P1|Participant Flow|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
759283|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
759284|NCT01565356|O1|Outcome|All Scans|22 florbetapir-PET scans obtained in Study A01(NCT01565291) and and 19 scans obtained in A03(NCT01565330)
759285|NCT01565356|E1|Reported Event|All Subject Scans|22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03
759286|NCT01565343|B4|Baseline|Total|Total of all reporting groups
759287|NCT01565343|B3|Baseline|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
759288|NCT01565343|B2|Baseline|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
759289|NCT01565343|B1|Baseline|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
759290|NCT01565343|P3|Participant Flow|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
759291|NCT01565343|P2|Participant Flow|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
759292|NCT01565343|P1|Participant Flow|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
759293|NCT01565343|O2|Outcome|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
759294|NCT01565343|O1|Outcome|AD Subjects|Male or female subjects > 50 years old; probable Alzheimer's Disease) AD according to National Institute of Neurological and Communication Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria; Mini-Mental State Examination (MMSE) 10-24
759295|NCT01565343|E3|Reported Event|Control Subjects|Healthy male or female subjects; 35-55 years old; no evidence of cognitive impairment; MMSE 29 or higher
759296|NCT01565343|E2|Reported Event|AD Subjects: Slow vs. Fast Bolus Group|Same inclusion criteria as AD subjects. The first injection given as a rapid bolus (< 5 second injection, with immediate flush). The second injection given as a slow bolus (approximately 20 to 30 second injection with a flush delayed by 10 seconds after dose administration).
759297|NCT01565343|E1|Reported Event|AD Subjects|Male or female subjects > 50 years old; probable AD according to NINCDS-ADRDA criteria; MMSE 10-24
759298|NCT01565330|B5|Baseline|Total|Total of all reporting groups
759299|NCT01565330|B4|Baseline|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
759300|NCT01565330|B3|Baseline|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
759301|NCT01565330|B2|Baseline|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
759302|NCT01565330|B1|Baseline|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
759303|NCT01565330|P4|Participant Flow|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
759304|NCT01565330|P3|Participant Flow|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
759305|NCT01565330|P2|Participant Flow|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
759306|NCT01565330|P1|Participant Flow|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
759307|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
759308|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
759309|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
759310|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
759311|NCT01565330|O4|Outcome|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
759312|NCT01565330|O3|Outcome|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
759313|NCT01565330|O2|Outcome|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
759314|NCT01565330|O1|Outcome|111 MBq (3 mCi) AD Group|Subjects with Alzheimer's Disease (AD) who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
759315|NCT01565330|E4|Reported Event|370 MBq (10 mCi) Control Group|Healthy controls who received 370MBq (10 mCi) of florbetapir F 18
759316|NCT01565330|E3|Reported Event|370 MBq (10 mCi) AD Group|Subjects with AD who received 370MBq (10 mCi) of florbetapir F 18
759317|NCT01565330|E2|Reported Event|111 MBq (3 mCi) Control Group|Healthy controls who received 111MBq (3 mCi) of florbetapir F 18
759318|NCT01565330|E1|Reported Event|111 MBq (3 mCi) AD Group|Subjects with AD who received 111MBq (3 mCi) of florbetapir F 18; MBq=megabecquerel
759319|NCT01565291|B3|Baseline|Total|Total of all reporting groups
759320|NCT01565291|B2|Baseline|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
759321|NCT01565291|B1|Baseline|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
759322|NCT01565291|P2|Participant Flow|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
759323|NCT01565291|P1|Participant Flow|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
759324|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
759325|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
759326|NCT01565291|O2|Outcome|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
759327|NCT01565291|O1|Outcome|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
759328|NCT01565291|E2|Reported Event|Healthy Elderly Subjects|Cognitively normal with MMSE of 29 or higher; age 50 years or older
759329|NCT01565291|E1|Reported Event|Subjects With AD|Probable AD, National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, with mild/moderate dementia (Mini-Mental State Examination [MMSE] from 10 to 24)
759330|NCT01565083|B3|Baseline|Total|Total of all reporting groups
759331|NCT01565083|B2|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759332|NCT01565083|B1|Baseline|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759333|NCT01565083|P2|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759532|NCT01564459|E2|Reported Event|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
759334|NCT01565083|P1|Participant Flow|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg per kilogram (mg/kg) on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg per meter-squared (mg/m^2) on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759335|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759384|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759385|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759336|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759337|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759338|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759339|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759340|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759341|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759342|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759372|NCT01564862|P2|Participant Flow|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759373|NCT01564862|P1|Participant Flow|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759343|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759344|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
813193|NCT01349829|E3|Reported Event|HAVPur - Second Vaccination|
759345|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759346|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759347|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759348|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759349|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759350|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759351|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759374|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759375|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
760381|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
759352|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759353|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759354|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759355|NCT01565083|O2|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759356|NCT01565083|O1|Outcome|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759357|NCT01565083|E2|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs was well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg was administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759358|NCT01565083|E1|Reported Event|Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion|Pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (cycle length = 21 days), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 2 of Cycle 1, followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (administered after trastuzumab) at a dose of 25 mg/m^2 on Day 2 and Day 9 of Cycle 1, followed by 30-35 mg/m^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab were administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
759359|NCT01564953|B1|Baseline|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
759360|NCT01564953|P1|Participant Flow|Serum Vitamin D, Magnesium and Calcium Deficient Groups|Participants were distributed into wether they were serum vitamin D, magnesium and calcium sufficiency or deficiency.
759361|NCT01564953|O1|Outcome|Quality of Life|Quality of life measured by Chronic Obstructive Pulmonary Disease Assesment Test
759362|NCT01564953|O1|Outcome|Serum Calcium|Serum ionized calcium, in mmol/L
759363|NCT01564953|O1|Outcome|Serum Magnesium|Serum magnesium in plasma, in mmol/L
759364|NCT01564953|O1|Outcome|Lung Function|lung function measured as forced expiratory volumes in 1 second.
759365|NCT01564953|O1|Outcome|Serum Vitamin D|Participants' serum vitamin D
759366|NCT01564953|E1|Reported Event||Adverse Events were not collected for the 143 participants
759367|NCT01564862|B4|Baseline|Total|Total of all reporting groups
759368|NCT01564862|B3|Baseline|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759369|NCT01564862|B2|Baseline|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759370|NCT01564862|B1|Baseline|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759371|NCT01564862|P3|Participant Flow|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
768461|NCT01520987|B9|Baseline|Total|Total of all reporting groups
759376|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759377|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759378|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759379|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759380|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759381|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759382|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759383|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759386|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759387|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759388|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759389|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759390|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759391|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759392|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759393|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759394|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759395|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759396|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759397|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759398|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759399|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759400|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759401|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759402|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759403|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759404|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759405|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759406|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759407|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759408|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759409|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759410|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759411|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759412|NCT01564862|O3|Outcome|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759413|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759414|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759416|NCT01564862|O2|Outcome|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759417|NCT01564862|O1|Outcome|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759418|NCT01564862|E3|Reported Event|Placebo|Placebo matching capsules, orally, once daily for up to 9 weeks (includes 1 week taper down period).
759419|NCT01564862|E2|Reported Event|Duloxetine|Duloxetine 60 mg, capsules, orally, for up to 8 weeks. Duloxetine 30 mg, capsule, orally, once daily for 1 week taper-down period.
759420|NCT01564862|E1|Reported Event|Vortioxetine (Lu AA21004)|Vortioxetine (Lu AA21004) 10 mg, capsules, orally, once daily for one week; then dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks.
759421|NCT01564758|B1|Baseline|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
759422|NCT01564758|P1|Participant Flow|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
759423|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
759424|NCT01564758|O1|Outcome|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
759425|NCT01564758|E1|Reported Event|Linezolid|Linezolid (Zyvox) 600 milligram (mg) either intravenously or orally every 12 hours (hrs) for 10 to 28 days or 400 mg orally every 12 hrs for 10 to 14 days until the infection was completely resolved or in accordance with investigator’s discretion.
759426|NCT01564732|B3|Baseline|Total|Total of all reporting groups
759427|NCT01564732|B2|Baseline|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759428|NCT01564732|B1|Baseline|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759429|NCT01564732|P2|Participant Flow|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759430|NCT01564732|P1|Participant Flow|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759431|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759432|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759471|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
761724|NCT01553318|E1|Reported Event|Ketotifen|Received ketotifen the active drug
759433|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759434|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759482|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
759483|NCT01563406|E4|Reported Event|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
759435|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759436|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759437|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759438|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759439|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759440|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759441|NCT01564732|O2|Outcome|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759472|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
759473|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
759474|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec.
761887|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
759442|NCT01564732|O1|Outcome|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759443|NCT01564732|E2|Reported Event|Plicated-LAGB|"Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to anchor the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.~Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
759444|NCT01564732|E1|Reported Event|Standard-LAGB|"Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.~Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures."
759445|NCT01564706|B1|Baseline|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
759446|NCT01564706|P1|Participant Flow|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
759447|NCT01564706|O1|Outcome|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
759448|NCT01564706|E1|Reported Event|Healthy Volunteers|Single i.v. administration of approximately 10mCi 18F-AV-45
759449|NCT01564693|B4|Baseline|Total|Total of all reporting groups
759450|NCT01564693|B3|Baseline|CONTROL GROUP|These were healthy subjects. 1 MD working at the Oncology Dept. , 1 family member of one of the patients enrolled.
759451|NCT01564693|B2|Baseline|NON-ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as non-anorexic
759452|NCT01564693|B1|Baseline|ANOREXIC CANCER PATIENTS|Based on the anorexia instruments that we used, we considered these patients as anorexic.
759453|NCT01564693|P3|Participant Flow|CONTROL GROUP|Two healthy volunteers were evaluated and included in the study as controls. Their appetite was normal, as assessed by appetite measurement tools.
759454|NCT01564693|P2|Participant Flow|NON-ANOREXIC CANCER PATIENTS|According to the protocol, we evaluated 4 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the absence of anorexia was assessed by appetite assessment tools.
759455|NCT01564693|P1|Participant Flow|ANOREXIC CANCER PATIENTS|We evaluated 9 patients with lung cancer who met the inclusion criteria and were enrolled in the study. According to the protocol, the presence of anorexia was assessed by appetite assessment tools.
759456|NCT01564693|O3|Outcome|CONTROL GROUP|Healthy subjects were studied regarding BOLD signal activity by fMRI
759457|NCT01564693|O2|Outcome|NON-ANOREXIC CANCER PATIENTS|Patients revealed as non-anorexic were studied regarding BOLD signal activity by fMRI
759458|NCT01564693|O1|Outcome|ANOREXIC CANCER PATIENTS|Patients revealed as anorexic were studied regarding BOLD signal activity by fMRI
759459|NCT01564693|E3|Reported Event|CONTROL GROUP|Two volunteers were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
759460|NCT01564693|E2|Reported Event|NON-ANOREXIC CANCER PATIENTS|Four patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
759461|NCT01564693|E1|Reported Event|ANOREXIC CANCER PATIENTS|Nine patients were studied by fMRI before and after administration of a standard meal. The presence of serious adverse events (i.e., allergy, claustrophobia) were investigated. The presence of nausea and vomiting after the intake of the standard meal was also investigated.
759462|NCT01563406|B5|Baseline|Total|Total of all reporting groups
759463|NCT01563406|B4|Baseline|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
759464|NCT01563406|B3|Baseline|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
759465|NCT01563406|B2|Baseline|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
759466|NCT01563406|B1|Baseline|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
759467|NCT01563406|P4|Participant Flow|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
759468|NCT01563406|P3|Participant Flow|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
759469|NCT01563406|P2|Participant Flow|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
759470|NCT01563406|P1|Participant Flow|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
759475|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec
759476|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
759477|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
759478|NCT01563406|O1|Outcome|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
759479|NCT01563406|O4|Outcome|Chlorhexidine+Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 5 sec.
759480|NCT01563406|O3|Outcome|Alcohol, 5 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
759481|NCT01563406|O2|Outcome|Chlorhexidine+Alcohol, 15 Second Scrub|Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec.
759484|NCT01563406|E3|Reported Event|Alcohol, 5 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 5 sec.
759485|NCT01563406|E2|Reported Event|Chlorhexidine+Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 3.15% chlorhexidine gluconate(CHG)/70% isopropyl alcohol for 15 sec
759486|NCT01563406|E1|Reported Event|Alcohol, 15 Second Scrub|- Description: Each catheter hub was disinfected before each access by scrubbing with 70% isopropyl alcohol alone for 15 sec
759487|NCT01564537|B3|Baseline|Total|Total of all reporting groups
759488|NCT01564537|B2|Baseline|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759489|NCT01564537|B1|Baseline|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759490|NCT01564537|P2|Participant Flow|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759491|NCT01564537|P1|Participant Flow|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to end of treatment (EOT) projected at 80 months.
759492|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759493|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759494|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759495|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759496|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759497|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759498|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759529|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
759530|NCT01564459|O1|Outcome|MK-6096|Participants who were randomly assigned to receive MK-6096 10 mg during double blind treatment period.
759499|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759500|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759501|NCT01564537|O1|Outcome|Ixazomib + Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759502|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759547|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
759548|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
759503|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759504|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759505|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759506|NCT01564537|O2|Outcome|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759507|NCT01564537|O1|Outcome|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759508|NCT01564537|E2|Reported Event|Placebo + Lenalidomide + Dexamethasone|Ixazomib placebo-matching capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity, whichever occurred first up to EOT projected at 80 months.
759509|NCT01564537|E1|Reported Event|Ixazomib+ Lenalidomide + Dexamethasone|Ixazomib 4 mg, capsules, orally, once, on Days 1, 8 and 15; plus lenalidomide 25 mg, orally, once, on Days 1 through 21; and dexamethasone 40 mg, orally, once, on Days 1, 8, 15 and 22 of a 28-day cycle for multiple cycles until progressive disease (PD) or unacceptable toxicity up to EOT projected at 80 months.
759510|NCT01564459|B4|Baseline|Total|Total of all reporting groups
759511|NCT01564459|B3|Baseline|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
759512|NCT01564459|B2|Baseline|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period
759513|NCT01564459|B1|Baseline|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
759514|NCT01564459|P3|Participant Flow|MK-6096 10 mg→Placebo|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive placebo during double-blind treatment period.
759515|NCT01564459|P2|Participant Flow|MK-6096 10 mg→MK-6096 10 mg|Participants that received MK-6096 10 mg during run-in and were randomly assigned to receive MK-6096 10 mg during double-blind treatment period.
759516|NCT01564459|P1|Participant Flow|MK-6096 10 mg→No Treatment|Participants who received MK-6096 10 mg during run-in and did not continue to double-blind treatment period.
759517|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
759518|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
759519|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
759520|NCT01564459|O3|Outcome|Placebo- Double-Blind Period|Participants who received placebo during double-blind treatment period
759521|NCT01564459|O2|Outcome|MK-6096 10 Mg-Double Blind Period|Participants who received MK-6096 during double blind treatment period
759522|NCT01564459|O1|Outcome|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
759523|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
759524|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
759525|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
759526|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
759527|NCT01564459|O2|Outcome|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
759528|NCT01564459|O1|Outcome|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
759533|NCT01564459|E1|Reported Event|MK-6096 10 mg - Run-in Period|Participants who received MK-6096 10 mg during run-in period
759534|NCT01564407|B6|Baseline|Total|Total of all reporting groups
759535|NCT01564407|B5|Baseline|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
759536|NCT01564407|B4|Baseline|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
759537|NCT01564407|B3|Baseline|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
759538|NCT01564407|B2|Baseline|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
759539|NCT01564407|B1|Baseline|No Injection|Empty safety control, no injection
759540|NCT01564407|P5|Participant Flow|Admin Drug Day 0 and 28|Single administration day 0 and 28
759541|NCT01564407|P4|Participant Flow|Single Admin Drug Day 28|Single administration on Day 28
759542|NCT01564407|P3|Participant Flow|Single Admin Drug Day 0|Single administration of study drug on day 0
759543|NCT01564407|P2|Participant Flow|Vehicle Only|Vehicle only (0.5 ml of solution)
759544|NCT01564407|P1|Participant Flow|No Injection|Safety cohort. 4 subjects received empty control. No injection
759545|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
759546|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
759551|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
759552|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
759553|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
759554|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
759555|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
759556|NCT01564407|O4|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
759557|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
759558|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
759559|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
759560|NCT01564407|O5|Outcome|Vehicle Only|Vehicle only (0.5 ml of HypoThermosol solution)
759561|NCT01564407|O4|Outcome|No Injection|Empty safety control, no injection
759562|NCT01564407|O3|Outcome|Admin Day 0 and 28|5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ day 28
759563|NCT01564407|O2|Outcome|Single Admin Day 28|5 million cells/ cm² , single administration at day 28
759564|NCT01564407|O1|Outcome|Single Admin Day 0|5 million cells / cm² , single administration at Day 0
759565|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration of study drug on day 28
759566|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
759567|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
759568|NCT01564407|O1|Outcome|no Injection|Safety cohort. 4 subjects received empty control. No injection
759569|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration on Day 28
759570|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
759571|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
759572|NCT01564407|O1|Outcome|No Injection|Safety cohort. 4 subjects received empty control. No injection
759573|NCT01564407|O4|Outcome|Single Admin Drug Day 28|Single administration of study drug on day 28
759574|NCT01564407|O3|Outcome|Single Admin Drug Day 0|Single administration of study drug on day 0
759575|NCT01564407|O2|Outcome|Vehicle Only|Vehicle only (0.5 ml of solution)
759576|NCT01564407|O1|Outcome|no Injection|Empty control no injection
759577|NCT01564407|E5|Reported Event|no Injection|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
759578|NCT01564407|E4|Reported Event|Admin Day 0 and 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
759579|NCT01564407|E3|Reported Event|Single Admin Day 28|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
759580|NCT01564407|E2|Reported Event|Single Admin Day 0|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
759581|NCT01564407|E1|Reported Event|Vehicle Only,|Adverse events in each cohort included pain, swelling and redness at the site of injection that resolved within 8 hours of treatment
759582|NCT01564394|B3|Baseline|Total|Total of all reporting groups
759583|NCT01564394|B2|Baseline|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
759632|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759873|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759584|NCT01564394|B1|Baseline|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
759585|NCT01564394|P2|Participant Flow|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
759637|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759638|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759586|NCT01564394|P1|Participant Flow|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
759587|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
759588|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
759589|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
759590|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
759591|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
759592|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
759593|NCT01564394|O2|Outcome|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
759960|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759594|NCT01564394|O1|Outcome|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
759595|NCT01564394|E2|Reported Event|Stretching Control|"The non-aerobic stretching will serve as an attention control group to control for non-specific factors; dose of attention and to mimic being in a group setting.~Non-aerobic stretching : The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation."
759596|NCT01564394|E1|Reported Event|Qigong|"Qigong originated in China hundreds of years ago and has been practiced for centuries. It consists of a sequence of slow, flowing physical movements with concentration on the breath and awareness and may promote physical and mental relaxation and energy balance.~Qigong : Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors."
759597|NCT01563978|B3|Baseline|Total|Total of all reporting groups
759598|NCT01563978|B2|Baseline|PLACEBO|Oral treatment
759599|NCT01563978|B1|Baseline|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759600|NCT01563978|P2|Participant Flow|PLACEBO|Oral treatment
759601|NCT01563978|P1|Participant Flow|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759602|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759603|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759604|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759605|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759606|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759607|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759608|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759609|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759610|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759611|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759612|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759613|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759614|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759615|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759616|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759617|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759618|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759619|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759620|NCT01563978|O2|Outcome|PLACEBO|Oral treatment
759621|NCT01563978|O1|Outcome|FOSTA 100 MG BID|Fostamatinib 100 mg bid, oral treatment
759622|NCT01563978|E2|Reported Event|PLACEBO|
759623|NCT01563978|E1|Reported Event|FOSTA 100 MG BID|
759624|NCT01563536|B3|Baseline|Total|Total of all reporting groups
759625|NCT01563536|B2|Baseline|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759626|NCT01563536|B1|Baseline|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759627|NCT01563536|P2|Participant Flow|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759628|NCT01563536|P1|Participant Flow|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759629|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759630|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759631|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759633|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759634|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759635|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759636|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
760397|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
759639|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759640|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759641|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759642|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759643|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759644|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759645|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759646|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759647|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759648|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759649|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759650|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759651|NCT01563536|O2|Outcome|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759652|NCT01563536|O1|Outcome|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759653|NCT01563536|E2|Reported Event|ABT-267 25 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (25 mg once daily) as monotherapy for 2 days, then ABT-267 (25 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759654|NCT01563536|E1|Reported Event|ABT-267 1.5 mg, Then ABT-267, ABT-450/r, ABT-333, Plus RBV|ABT-267 (1.5 mg once daily) as monotherapy for 2 days, then ABT-267 (1.5 mg once daily), ABT-450/r (150 mg/ 100 mg once daily) and ABT-333 (400 mg twice daily), plus weight-based RBV (dosed 1,000 or 1,200 mg daily divided twice a day) combination therapy for 12 weeks
759655|NCT01563198|B1|Baseline|Comfort Talk® Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
759656|NCT01563198|P1|Participant Flow|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
759657|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
759658|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
759659|NCT01563198|O1|Outcome|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
759660|NCT01563198|E1|Reported Event|Comfort TalkTM Training|"The MRI units of three clinical sites form the group. Their personnel will be trained to use Comfort TalkTm to help patients who are claustrophobic, anxious, and/or cannot lie still to complete their tests~Comfort Talk: Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training."
759661|NCT01563185|B1|Baseline|DUEXIS|"800 mg ibuprofen/26.6 mg famotidine~800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day"
759662|NCT01563185|P1|Participant Flow|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759663|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759664|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759665|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759666|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759667|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759668|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759669|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759670|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759671|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759672|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759673|NCT01563185|O1|Outcome|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759674|NCT01563185|E1|Reported Event|DUEXIS|800 mg ibuprofen/26.6 mg famotidine: Oral tablet taken three time per day
759675|NCT01563081|B3|Baseline|Total|Total of all reporting groups
759676|NCT01563081|B2|Baseline|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
759677|NCT01563081|B1|Baseline|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
759678|NCT01563081|P2|Participant Flow|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
759679|NCT01563081|P1|Participant Flow|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
759680|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
759961|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759681|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
759682|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
759683|NCT01563081|O1|Outcome|Levocetrizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
759684|NCT01563081|O1|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
759685|NCT01563081|O3|Outcome|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
759686|NCT01563081|O2|Outcome|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
759882|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759687|NCT01563081|O1|Outcome|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
759688|NCT01563081|E3|Reported Event|Levocetirizine: Total Population|Participants received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution: once daily for participants who were >=6 months and <12 months old; twice daily for participants who were >=12 months and <24 months old) for a duration of 2 weeks.
759689|NCT01563081|E2|Reported Event|Levocetirizine: >=12 Months and <24 Months Old|Participants who were >=12 months and <24 months old received levocetirizine 1.25 mg (2.5 mL as levocetirizine oral solution) twice daily (in the morning and in the evening before going to sleep) for a duration of 2 weeks.
759690|NCT01563081|E1|Reported Event|Levocetirizine: >=6 Months and <12 Months Old|Participants who were >=6 months and <12 months old received levocetirizine 1.25 milligrams (mg) (2.5 milliliters [mL] as levocetirizine oral solution) once daily in the morning for a duration of 2 weeks.
759691|NCT01563055|B1|Baseline|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759692|NCT01563055|P1|Participant Flow|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759693|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759694|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759756|NCT01563029|P4|Participant Flow|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759695|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759766|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759767|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
760405|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
759696|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759697|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759698|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759699|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759700|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759701|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759757|NCT01563029|P3|Participant Flow|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
771835|NCT01507662|O2|Outcome|Control|Usual care
759702|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759703|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759704|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759705|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759706|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759707|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759708|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759758|NCT01563029|P2|Participant Flow|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759709|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759710|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759711|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759712|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759713|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759714|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759715|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759759|NCT01563029|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759716|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759717|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759718|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759719|NCT01563055|O1|Outcome|Overall Study Arm|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759720|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759721|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759722|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759760|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
772880|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
759723|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759724|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759725|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759726|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759727|NCT01563055|O1|Outcome|Ofatumumab +Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759728|NCT01563055|O1|Outcome|Overall Study Arm|ar. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759729|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759761|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
761888|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
759730|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759731|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759732|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759733|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759734|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759735|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759736|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759762|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
772881|NCT01500317|O3|Outcome|Placebo|Placebo tid
759737|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759738|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759739|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759740|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759741|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759742|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759743|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759763|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759744|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759745|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759746|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759747|NCT01563055|O1|Outcome|Ofatumumab + Chlorambucil|Par. with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28-day cycle in combination with oral chlorambucil 10 mg/meter squared (m^2) on Days 1-7 of each cycle for at least 3 cycles, until best overall response or up to 12 cycles. After the Treatment Phase (for par. in CR, PR or SD), survival and disease status were assessed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 and 168 days after the day of FU1 (FU85 and FU169, respectively). For par. with disease progression (PD) during the Treatment Phase, post PD follow-up were done 28 days after the first day of the last treatment cycle (PDFU1) to assess safety. Survival status, date of next CLL therapy, and type of therapy were subsequently assessed 84 and 168 days after the day of PDFU1 (PDFU85 and PDFU169, respectively).
759748|NCT01563055|E1|Reported Event|Ofatumumab+Chlorambucil|Participants with previously untreated chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by 1000 mg on the first day of each subsequent 28 day cycle in combination with chlorambucil 10 mg/meter squared (m^2) orally on Days 1-7 of every 28 day cycle for a minimum of 3 cycles, until best overall response or a maximum of 12 cycles. After completion of the Treatment Phase (for participants in CR, PR or SD), survival and disease status assessment visits were performed 28 days after the first day of the last treatment cycle (Follow-up [FU] 1), 84 days, and 168 days after the day of FU 1 (FU 85 and FU 169, respectively). For participants experiencing disease progression during the Treatment Phase, the post progressive disease (PD) follow-up for safety assessments were performed 28 days after the first day of the last treatment cycle (PDFU 1). Subsequent follow-up was performed 8
759749|NCT01563029|B6|Baseline|Total|Total of all reporting groups
759750|NCT01563029|B5|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759751|NCT01563029|B4|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759752|NCT01563029|B3|Baseline|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759753|NCT01563029|B2|Baseline|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759754|NCT01563029|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759755|NCT01563029|P5|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759764|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759765|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759877|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759768|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759769|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759770|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759771|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759772|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759773|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759774|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759775|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759776|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759777|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759778|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759779|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759780|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759781|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759782|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759962|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759783|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759784|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759785|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759878|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
760478|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
759786|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759787|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759788|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759789|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759790|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759791|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759792|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759793|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759794|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759795|NCT01563029|O6|Outcome|Average of FF 50 µg OD and FF 100 µg OD|All participants who received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks and all participants who FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759796|NCT01563029|O5|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759797|NCT01563029|O4|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759798|NCT01563029|O3|Outcome|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759799|NCT01563029|O2|Outcome|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759800|NCT01563029|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759870|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759963|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759801|NCT01563029|E5|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID, once in the morning and once in the evening via a DPI and placebo OD in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759802|NCT01563029|E4|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759803|NCT01563029|E3|Reported Event|FF 50 µg OD|Participants received FF 50 µg OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759804|NCT01563029|E2|Reported Event|FF 25 µg OD|Participants received fluticasone furoate (FF) 25 micrograms (µg) OD in the evening via a DPI and placebo BID, once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759805|NCT01563029|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening via a dry powder inhaler (DPI) and placebo twice daily (BID), once in the morning and once in the evening via a separate DPI for 12 weeks. Participants were also provided albuterol/salbutamol inhalation aerosol via metered dose inhaler (MDI) to be used as rescue medication as determined by the investigator.
759806|NCT01563003|B3|Baseline|Total|Total of all reporting groups
759807|NCT01563003|B2|Baseline|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
759808|NCT01563003|B1|Baseline|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
759809|NCT01563003|P2|Participant Flow|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
759810|NCT01563003|P1|Participant Flow|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
759811|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
759812|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
759813|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
759814|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
772882|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
759815|NCT01563003|O2|Outcome|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
759879|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759880|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759816|NCT01563003|O1|Outcome|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
759817|NCT01563003|E2|Reported Event|Treatment as Usual|"This arm acts as the comparison condition. Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.~Treatment as usual: This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them."
759818|NCT01563003|E1|Reported Event|Cognitive Behavioral Therapy Condition|"This arm is the experimental condition; it consists of 16 weekly CBT sessions. This intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposures to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases~Cognitive Behavioral Therapy: This condition involves 16 weekly CBT sessions."
759819|NCT01562886|B1|Baseline|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
759820|NCT01562886|P1|Participant Flow|Rilpivirine and Truvada|TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily
759821|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 25mg"
759822|NCT01562886|O1|Outcome|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 25mg"
759823|NCT01562886|E1|Reported Event|Rilpivirine and Truvada|"TDF/FTC (Truvada™) one tablet once plus Rilpivirine 25 mg daily~Rilpivirine: Rilpivirine 26mg"
759824|NCT01562873|B1|Baseline|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759825|NCT01562873|P2|Participant Flow|Ruxolitinib-Cohort B|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759826|NCT01562873|P1|Participant Flow|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759827|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759828|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759829|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759871|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759872|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759830|NCT01562873|O1|Outcome|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759881|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759831|NCT01562873|E1|Reported Event|Ruxolitinib-Cohort A|Patients received Ruxolitinib 25 mg twice daily for up to 12 cycles (cycle duration=28 days) until evidence of disease progression or unacceptable toxicity. Patients enrolled sequentially into two possible cohorts based on pStat3+ expression score by central testing: Cohort A - moderate to high positive status defined as a score of >/=5 by central testing or Cohort B - low positive status defined as a score of 3-4. Each cohort was evaluated with a 2 stage design. Cohort B only opened if 2 objective responses were observed in 1st stage Cohort A patients (n=21).
759832|NCT01562743|B1|Baseline|SPM 962|Rotigotine transdermal patch
759833|NCT01562743|P1|Participant Flow|SPM 962|"Rotigotine transdermal patch~A patch containing 2.25 - 6.75mg of rotigotine was administered once a day."
759834|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
759835|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
759836|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
759837|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
759838|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
759839|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
759840|NCT01562743|O1|Outcome|SPM 962|Rotigotine transdermal patch
759841|NCT01562743|E1|Reported Event|SPM 962|Rotigotine transdermal patch
759842|NCT01562678|B3|Baseline|Total|Total of all reporting groups
759843|NCT01562678|B2|Baseline|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
759844|NCT01562678|B1|Baseline|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
759845|NCT01562678|P2|Participant Flow|Placebo First, Then Liraglutide|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
759846|NCT01562678|P1|Participant Flow|Liraglutide First, Then Placebo|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
759847|NCT01562678|O2|Outcome|Placebo|Placebo: In the placebo phase of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects will self-inject placebo once per day for 18 days. Participants had this first or second (liraglutide was the other phase).
759848|NCT01562678|O1|Outcome|Liraglutide|Liraglutide: In the experimental phase of this randomized, placebo-controlled, cross-over, double-blinded study to assess the effects of liraglutide, subjects started the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week. This sequence may have occurred for their first phase or second phase (placebo was the other phase).
759849|NCT01562678|E2|Reported Event|Placebo|14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide and 14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo
759850|NCT01562678|E1|Reported Event|Liraglutide|14 participants were randomized to receive Liraglutide and then were cross-overed to receive placebo and 14 participants were randomized to receive Placebo and then were cross-overed to receive Liraglutide
759851|NCT01562613|B1|Baseline|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
759852|NCT01562613|P1|Participant Flow|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
759853|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
759854|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
759855|NCT01562613|O1|Outcome|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
759856|NCT01562613|E1|Reported Event|Hypertensive Patients|All eligible hypertensive patients treated with eprosartan
759857|NCT01562548|B5|Baseline|Total|Total of all reporting groups
759858|NCT01562548|B4|Baseline|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759859|NCT01562548|B3|Baseline|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759860|NCT01562548|B2|Baseline|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759861|NCT01562548|B1|Baseline|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759862|NCT01562548|P4|Participant Flow|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759863|NCT01562548|P3|Participant Flow|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759864|NCT01562548|P2|Participant Flow|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759865|NCT01562548|P1|Participant Flow|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759866|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759867|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759868|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759869|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759874|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759875|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759876|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759883|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759884|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759885|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759886|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759887|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759888|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759889|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759890|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759891|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759892|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759893|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759894|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759895|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759896|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759897|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759898|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759899|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759900|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759901|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759902|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759903|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759904|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759905|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759906|NCT01562548|O4|Outcome|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID for 7 consecutive days
759907|NCT01562548|O3|Outcome|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759908|NCT01562548|O2|Outcome|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID for 7 consecutive days
759909|NCT01562548|O1|Outcome|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759910|NCT01562548|E4|Reported Event|Placebo Matching Guaifenesin 1200mg|2 placebo tablets matching Guaifenesin 1200mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759911|NCT01562548|E3|Reported Event|Guaifenesin 1200mg|2 Guaifenesin 600mg Extended Release Tablets taken orally with 150ml of water BID, for 7 consecutive days
759912|NCT01562548|E2|Reported Event|Placebo Matching Guaifenesin 600mg|1 placebo tablet matching Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water BID, for 7 consecutive days
759913|NCT01562548|E1|Reported Event|Guaifenesin 600mg|Guaifenesin 600mg Extended Release Tablet taken orally with 150ml of water twice daily (BID), for 7 consecutive days
759914|NCT01562327|B1|Baseline|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
759915|NCT01562327|P1|Participant Flow|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
759916|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759917|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759918|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759919|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759920|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759921|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
760479|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
759922|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759923|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759924|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759925|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759926|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759927|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759928|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759929|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759930|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
759931|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
759932|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe rheumatoid arthritis (RA) received Tocilizumab according to individualized physician-prescribed regimens.
759933|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759934|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759935|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759936|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759937|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759938|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759939|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759940|NCT01562327|O1|Outcome|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759941|NCT01562327|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA received Tocilizumab according to individualized physician-prescribed regimens.
759942|NCT01562314|B3|Baseline|Total|Total of all reporting groups
759943|NCT01562314|B2|Baseline|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759944|NCT01562314|B1|Baseline|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759945|NCT01562314|P2|Participant Flow|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759946|NCT01562314|P1|Participant Flow|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759947|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
759948|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
759949|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759950|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759951|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
759952|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
759953|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759954|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759955|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759956|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759957|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759958|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759959|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759964|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759965|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759966|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759967|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759968|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759969|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759970|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759971|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken, twice daily. 10 week treatment period.
759972|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily, 10 week treatment period."
759973|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759974|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759975|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760483|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
759976|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759977|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759978|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759979|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759980|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759981|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759982|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759983|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759984|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759985|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759986|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759987|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759988|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759989|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759990|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759991|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759992|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759993|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759994|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759995|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759996|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759997|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
759998|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
759999|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760000|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760001|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760002|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760003|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760004|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760005|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760006|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760007|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760008|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760009|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760010|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760011|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760012|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760013|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760014|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760015|NCT01562314|O2|Outcome|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760016|NCT01562314|O1|Outcome|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760017|NCT01562314|E2|Reported Event|Placebo|Placebo: 1-5 capsules taken twice daily; 10 week treatment period.
760018|NCT01562314|E1|Reported Event|GWP42003|"(0-250mg, BD)~GWP42003: 1-5 capsules taken twice daily; 10 week treatment period."
760019|NCT01562275|B14|Baseline|Total|Total of all reporting groups
760276|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
760277|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760020|NCT01562275|B13|Baseline|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760021|NCT01562275|B12|Baseline|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760022|NCT01562275|B11|Baseline|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760283|NCT01561313|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760023|NCT01562275|B10|Baseline|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760024|NCT01562275|B9|Baseline|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760025|NCT01562275|B8|Baseline|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760026|NCT01562275|B7|Baseline|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760027|NCT01562275|B6|Baseline|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760028|NCT01562275|B5|Baseline|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760029|NCT01562275|B4|Baseline|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760030|NCT01562275|B3|Baseline|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760031|NCT01562275|B2|Baseline|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760032|NCT01562275|B1|Baseline|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760033|NCT01562275|P13|Participant Flow|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760034|NCT01562275|P12|Participant Flow|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760035|NCT01562275|P11|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760036|NCT01562275|P10|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760037|NCT01562275|P9|Participant Flow|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760038|NCT01562275|P8|Participant Flow|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760039|NCT01562275|P7|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760040|NCT01562275|P6|Participant Flow|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
813194|NCT01349829|E2|Reported Event|Havrix - First Vaccination|
760041|NCT01562275|P5|Participant Flow|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760042|NCT01562275|P4|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760043|NCT01562275|P3|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760044|NCT01562275|P2|Participant Flow|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760045|NCT01562275|P1|Participant Flow|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 milligrams (mg) cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760046|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760047|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760048|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760049|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760050|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760051|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760052|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760053|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760054|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760055|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
761889|NCT01552876|E3|Reported Event|Filcon II 3|Those who wore Filcon II 3 during Phase II
760056|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760057|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760058|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760284|NCT01561313|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
760059|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760060|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760061|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760062|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760063|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760064|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760065|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760066|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760067|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760068|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760069|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760070|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760071|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760072|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760073|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760278|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
760074|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760075|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760285|NCT01561300|B1|Baseline|Study Population|All participants who were randomised
760398|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760399|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760076|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760077|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760078|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760079|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760080|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760081|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760082|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760083|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760084|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760085|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760086|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760087|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760088|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760089|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760090|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760091|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760279|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760092|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760093|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760094|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760095|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760096|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760097|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760098|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760099|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760100|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760101|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760102|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760103|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760104|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760105|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760106|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760107|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760108|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760109|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760280|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
760281|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760110|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760111|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760112|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760113|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760114|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760115|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760116|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760117|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760118|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760119|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760120|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760121|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760122|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760123|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760124|NCT01562275|O13|Outcome|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760125|NCT01562275|O12|Outcome|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760126|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760127|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
761890|NCT01552876|E2|Reported Event|Nelfilcon A|Those subjects who wore nelfilcon A. (Phase I & II)
760128|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760129|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760130|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760131|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760132|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760133|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760134|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760135|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760136|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760137|NCT01562275|O1|Outcome|DECs and Expansion Cohorts|Included all participants who were treated under Stage 1 (Dose Escalation Cohorts) and Stage 2 (Dose Expansion Cohorts).
760138|NCT01562275|O1|Outcome|Stage 1 DECs|During Stage 1, participants received cobimetinib and ipatasertib combination doses either under Arm A (21/7 dosing schedule [cobimetinib and ipatasertib taken concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22-28, every 28 days]) or under Arm B (intermittent cobimetinib dosing schedule [ipatasertib taken once daily on Days 1-21 consecutively with concurrent dosing of cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22-28, every 28 days)] until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760139|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760140|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760141|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760142|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760143|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760144|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760145|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760282|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772883|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
760146|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760147|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760400|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
760148|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760149|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760150|NCT01562275|O11|Outcome|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760151|NCT01562275|O10|Outcome|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760152|NCT01562275|O9|Outcome|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760153|NCT01562275|O8|Outcome|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760154|NCT01562275|O7|Outcome|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760155|NCT01562275|O6|Outcome|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760156|NCT01562275|O5|Outcome|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760157|NCT01562275|O4|Outcome|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760158|NCT01562275|O3|Outcome|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760159|NCT01562275|O2|Outcome|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760160|NCT01562275|O1|Outcome|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760161|NCT01562275|E13|Reported Event|Breast Cancer: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with triple negative breast cancer received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760162|NCT01562275|E12|Reported Event|Endometrial Carcinoma: 140 mg Cobimetinib + 300 mg Ipatasertib|Participants with endometrial carcinoma received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 140 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760163|NCT01562275|E11|Reported Event|DEC Arm B: 100 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760186|NCT01561898|B2|Baseline|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760164|NCT01562275|E10|Reported Event|DEC Arm B: 150 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760321|NCT01560507|P3|Participant Flow|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
760165|NCT01562275|E9|Reported Event|DEC Arm B: 175 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 175 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760166|NCT01562275|E8|Reported Event|DEC Arm B: 150 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 300 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 150 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760167|NCT01562275|E7|Reported Event|DEC Arm B: 125 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 400 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760168|NCT01562275|E6|Reported Event|DEC Arm B: 125 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 125 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760169|NCT01562275|E5|Reported Event|DEC Arm B: 100 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 200 mg ipatasertib once daily on Days 1-21 consecutively with concurrent dosing of 100 mg cobimetinib on Days 1, 4, 8, 11, 15, and 18 with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760170|NCT01562275|E4|Reported Event|DEC Arm A: 40 mg Cobimetinib + 400 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 400 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760171|NCT01562275|E3|Reported Event|DEC Arm A: 60 mg Cobimetinib + 300 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 300 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760172|NCT01562275|E2|Reported Event|DEC Arm A: 60 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 60 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760173|NCT01562275|E1|Reported Event|DEC Arm A: 40 mg Cobimetinib + 200 mg Ipatasertib|Participants received oral 40 mg cobimetinib and 200 mg ipatasertib concurrently once daily on Days 1-21, with a 7-day dosing holiday on Days 22−28, every 28 days (1 Cycle=28 Days) until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
760174|NCT01562132|B3|Baseline|Total|Total of all reporting groups
760175|NCT01562132|B2|Baseline|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760176|NCT01562132|B1|Baseline|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760177|NCT01562132|P2|Participant Flow|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760178|NCT01562132|P1|Participant Flow|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760179|NCT01562132|O2|Outcome|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760180|NCT01562132|O1|Outcome|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760181|NCT01562132|E2|Reported Event|Fluconazole Alone|"Fluconazole monotherapy~Fluconazole: fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760182|NCT01562132|E1|Reported Event|5FC Plus Fluconazole|"Combination therapy with oral fluconazole and flucytosine~Flucytosine and fluconazole: Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily"
760183|NCT01561898|B5|Baseline|Total|Total of all reporting groups
760184|NCT01561898|B4|Baseline|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760185|NCT01561898|B3|Baseline|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760187|NCT01561898|B1|Baseline|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760188|NCT01561898|P4|Participant Flow|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760401|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
760189|NCT01561898|P3|Participant Flow|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760190|NCT01561898|P2|Participant Flow|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760191|NCT01561898|P1|Participant Flow|NO/PAL Group|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760192|NCT01561898|O1|Outcome|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760193|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760194|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760195|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760196|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760197|NCT01561898|O4|Outcome|OLZ/PAL|OLZ/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the olanzapine group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760198|NCT01561898|O3|Outcome|PAL/PAL Group|PAL/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the paliperidone ER group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760199|NCT01561898|O2|Outcome|PLA/PAL Group|PLA/PAL: group of continuing patients from JNS007ER-JPN-S31 in which they belonged to the placebo group. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760200|NCT01561898|O1|Outcome|NO/PAL|NO/PAL: group consisting of new patients. Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760201|NCT01561898|E1|Reported Event|Entire Group|Treatment is started with paliperidone extended release (ER) 6 mg once daily, and the dose is appropriately increased or decreased within the range from 3mg to 12 mg.
760202|NCT01561716|B7|Baseline|Total|Total of all reporting groups
760203|NCT01561716|B6|Baseline|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
760204|NCT01561716|B5|Baseline|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
760205|NCT01561716|B4|Baseline|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
760206|NCT01561716|B3|Baseline|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
760207|NCT01561716|B2|Baseline|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
760208|NCT01561716|B1|Baseline|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
760209|NCT01561716|P6|Participant Flow|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
760210|NCT01561716|P5|Participant Flow|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
760211|NCT01561716|P4|Participant Flow|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
760212|NCT01561716|P3|Participant Flow|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
760213|NCT01561716|P2|Participant Flow|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
760214|NCT01561716|P1|Participant Flow|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
760215|NCT01561716|O6|Outcome|Treadmill Running/Walking|Energy expenditure during 30 min treadmill running/walking
760216|NCT01561716|O5|Outcome|Wii Fit Rhythm Boxing|Energy expenditure during 10 min Wii Fit Rhythm Boxing
760217|NCT01561716|O4|Outcome|Wii Fit Advanced Steps|Energy expenditure during 10 min Wii Fit Advanced Steps
760218|NCT01561716|O3|Outcome|Wii Fit Super Hula Hoop|Energy expenditure during 10 min Wii Fit Super Hula Hoop
760219|NCT01561716|O2|Outcome|Wii Fit Free Run|Energy expenditure during 30 min Wii Fit Free Run
760220|NCT01561716|O1|Outcome|At Rest|Energy expenditure at rest
760221|NCT01561716|E6|Reported Event|Crossover Sequence 6|Resting/treadmill/Wii Fit 3 bouts/Wii Fit Free Run
760222|NCT01561716|E5|Reported Event|Crossover Sequence 5|Resting/treadmill/Wii Fit Free Run/Wii Fit 3 bouts
760223|NCT01561716|E4|Reported Event|Crossover Sequence 4|Resting/Wii Fit 3 bouts/treadmill/Wii Fit Free Run
760224|NCT01561716|E3|Reported Event|Crossover Sequence 3|Resting/Wii Fit 3 bouts/Wii Fit Free Run/treadmill
760225|NCT01561716|E2|Reported Event|Crossover Sequence 2|Resting/Wii Fit Free Run/treadmill/Wii Fit 3 bouts
760226|NCT01561716|E1|Reported Event|Crossover Sequence 1|Resting/Wii Fit Free Run/Wii Fit 3 bouts/treadmill
760227|NCT01561703|B3|Baseline|Total|Total of all reporting groups
760228|NCT01561703|B2|Baseline|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
760322|NCT01560507|P2|Participant Flow|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
760229|NCT01561703|B1|Baseline|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
760230|NCT01561703|P2|Participant Flow|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
760231|NCT01561703|P1|Participant Flow|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
760232|NCT01561703|O2|Outcome|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
760233|NCT01561703|O1|Outcome|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
760234|NCT01561703|E2|Reported Event|Control|"Patients will NOT receive postoperative antibiotic~No postoperative antibiotic: Patients will not be given a prescription for postoperative antibiotics"
760235|NCT01561703|E1|Reported Event|Intervention|"Patients will receive postoperative antibiotic after surgery.~Amoxicillin: Generic antibiotic at standard dosage that may be used for 7-10 days following surgery .~Amoxicillin/clavulanate potassium: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Azithromycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefaclor: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cephalexin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Cefdinir: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery~Clindamycin: Generic antibiotic given at standard dosage that may be used for 7-10 day after surgery"
760236|NCT01561560|B1|Baseline|OVERALL|Delefilcon A contact lenses and narafilcon A contact lenses worn in randomized order. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
760237|NCT01561560|P2|Participant Flow|TRUEYE, Then DAILIES TOTAL1|Narafilcon A contact lenses worn first, followed by delefilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
760238|NCT01561560|P1|Participant Flow|DAILIES TOTAL1, Then TRUEYE|Delefilcon A contact lenses worn first, followed by narafilcon A contact lenses. Each product was worn bilaterally on a daily wear, daily disposable basis for two weeks.
760239|NCT01561560|O2|Outcome|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
760240|NCT01561560|O1|Outcome|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
760241|NCT01561560|E2|Reported Event|TRUEYE|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
760242|NCT01561560|E1|Reported Event|DAILIES TOTAL1|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks
760243|NCT01561469|B3|Baseline|Total|Total of all reporting groups
760244|NCT01561469|B2|Baseline|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760245|NCT01561469|B1|Baseline|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760246|NCT01561469|P2|Participant Flow|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760247|NCT01561469|P1|Participant Flow|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760248|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760249|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760250|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760251|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760252|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760253|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760254|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760255|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760256|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760257|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760258|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760259|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760260|NCT01561469|O2|Outcome|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760261|NCT01561469|O1|Outcome|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760262|NCT01561469|E2|Reported Event|Vancomycin|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with vancomycin according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760263|NCT01561469|E1|Reported Event|Linezolid|Participants with diagnosis of ventilator-associated pneumonia (VAP) (subgroup of hospital-acquired pneumonia [HAP]) due to methicillin-resistant staphylococcus aureus (MRSA) and who were treated with linezolid according to routine local care were observed retrospectively for up to 28 days after the diagnosis of VAP.
760264|NCT01561313|B3|Baseline|Total|Total of all reporting groups
760265|NCT01561313|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
760266|NCT01561313|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
760267|NCT01561313|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
760268|NCT01561313|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
760269|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760270|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
760271|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760272|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
760273|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760274|NCT01561313|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
760275|NCT01561313|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
760375|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760286|NCT01561300|P2|Participant Flow|Tea, Then Wash Out, Then Control|Subjects first received Tea for one week with with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Control for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
760287|NCT01561300|P1|Participant Flow|Control, Then Washout, Then Tea|Subjects first received Control for one week with Flow Mediated Dilation (FMD) measurements on day 1 and day 8. After a washout of one week (day 8-15) they received Tea for one week with FMD measurements at day 16 and day 22. All FMD measurements were done in a fasted state just before test product intake and exactly 2 hours after test product intake.
760288|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
760289|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
760290|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
760291|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
760292|NCT01561300|O2|Outcome|Control Beverage|Participants when they received control
760293|NCT01561300|O1|Outcome|Tea Beverage|Participants when they received tea
760294|NCT01561300|E3|Reported Event|Placebo|Subjects when they consumed placebo for 6 days during the run in and during 7 days during the washout
760295|NCT01561300|E2|Reported Event|Control|Subjects when they consumed control for one week
760296|NCT01561300|E1|Reported Event|Tea Extract|Subjects when they consumed tea extract for one week
760297|NCT01560975|B1|Baseline|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
760298|NCT01560975|P1|Participant Flow|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
760299|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
760300|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
760301|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
760302|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
760303|NCT01560975|O4|Outcome|noPOAG/ no CPAP|No POAG patients without CPAP therapy
760304|NCT01560975|O3|Outcome|POAG/no CPAP|POAG patients without CPAP therapy
760305|NCT01560975|O2|Outcome|noPOAG/CPAP|no POAG patients with CPAP therapy
760306|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
760307|NCT01560975|O2|Outcome|noPOAG/CPAP|Subjects with CPAP
760308|NCT01560975|O1|Outcome|POAG/CPAP|POAG patients with CPAP therapy
760309|NCT01560975|E1|Reported Event|Sensimed Triggerfish|SENSIMED Triggerfish®: Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
760310|NCT01560819|B3|Baseline|Total|Total of all reporting groups
760311|NCT01560819|B2|Baseline|Donors|Healthy donors (>18 years of age) were chosen by participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
760312|NCT01560819|B1|Baseline|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
760313|NCT01560819|P2|Participant Flow|Donors|Healthy donors (>18 years of age) were chosen by the participants. Donors were required to complete a screening questionnaire, provide medical history, and undergo blood and stool tests.
760314|NCT01560819|P1|Participant Flow|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
760315|NCT01560819|O1|Outcome|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate ulcerative colitis (UC) (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. PUCAI is a validated tool to measure disease activity in pediatric UC based on clinical symptoms: a score of <10 = remission; 10-34 = mild disease; 35-64 = moderate disease; 65-85 = severe disease. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
760316|NCT01560819|E1|Reported Event|Study Participants|Ten participants between the ages of 7 to 21 years with mild-to moderate UC (pediatric UC activity index [PUCAI] between 15 and 65) were enrolled in the study. Participants had stable disease activity and medical treatment for UC for 2 months prior to enrollment. Participants' ongoing treatment for UC was not changed. None of the subjects had concurrent C difficile infection.
760317|NCT01560507|B4|Baseline|Total|Total of all reporting groups
760318|NCT01560507|B3|Baseline|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
760319|NCT01560507|B2|Baseline|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
760376|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
760320|NCT01560507|B1|Baseline|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
760387|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
760388|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
760323|NCT01560507|P1|Participant Flow|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
760324|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.~bupropion (Zyban) & nicotine patches: After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
760325|NCT01560507|O2|Outcome|Nicotine Patches|"This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.~nicotine patches: 21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks."
760326|NCT01560507|O1|Outcome|Varenicline (Chantix)|"This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.~varenicline (Chantix): For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
760327|NCT01560507|O3|Outcome|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
760328|NCT01560507|O2|Outcome|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
760329|NCT01560507|O1|Outcome|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
760330|NCT01560507|E3|Reported Event|Bupropion (Zyban) and Nicotine Patches|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received bupropion and nicotine patches.
760331|NCT01560507|E2|Reported Event|Nicotine Patches|This group consists of smokers who, based on smoking behavior, respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They continued to use only nicotine patches.
760332|NCT01560507|E1|Reported Event|Varenicline (Chantix)|This group consists of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation NRT (assessed the day before the scheduled quit day). They received varenicline.
760333|NCT01560429|B3|Baseline|Total|Total of all reporting groups
760334|NCT01560429|B2|Baseline|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
760335|NCT01560429|B1|Baseline|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in the post-anesthesia care unit (PACU). Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
760336|NCT01560429|P2|Participant Flow|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Postoperatively all patients received continuous epidural analgesia at infusion rates to reach pain scores of ≤ 3 while in PACU. Those randomized to the Continuous epidural analgesia group remained on the same CEA regimen.
760337|NCT01560429|P1|Participant Flow|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Continuous epidural infusion rates were set to achieve scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Upon allocation to the preoperatively determined randomization, the PCEA were switched the receive 2/3 of their baseline infusion as continuous background infusion but they also had the option to self administered the remaining 1/3rd of the dose via patient controlled epidural analgesia (PCEA)
760338|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
760339|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
760377|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
760378|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
760379|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
760380|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
760340|NCT01560429|O2|Outcome|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. CEA infusion rates were set to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in PACU. Those allocated to the CEA group remained on the same continuous epidural infusion rate to which they were optimized.
760389|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
760390|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760391|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760341|NCT01560429|O1|Outcome|Patient-controlled Epidural Analgesia|An epidural catheter sited preoperatively so analgesics can be administered postoperatively. Patients were titrated on a continuous analgesic epidural infusion until stable pain scores of ≤ 3 were reached while in PACU. Once stable, they were allocated to their preoperatively determined randomization which meant they still received 2/3rd of the anesthetic as a background infusion but also had the option to self-administer the remaining 1/3rd dose as patient controlled epidural analgesia (PCEA). Rescue analgesia was available upon request.
760342|NCT01560429|E2|Reported Event|Continuous Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
760343|NCT01560429|E1|Reported Event|Patient-controlled Epidural Analgesia|All patients were preoperatively sited with an epidural catheter in preparation for postoperative pain management. Patient controlled epidural analgesia : CEA infusion rates were set when pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 were achieved in PACU. Continuous epidural analgesia : PCEA parameters were adjusted to allow an equivalent dose per hour.
760344|NCT01560403|B3|Baseline|Total|Total of all reporting groups
760345|NCT01560403|B2|Baseline|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
760346|NCT01560403|B1|Baseline|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644)
760347|NCT01560403|P2|Participant Flow|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
760348|NCT01560403|P1|Participant Flow|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
760349|NCT01560403|O2|Outcome|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600 021 (NCT00930644).
760350|NCT01560403|O1|Outcome|NT,PBO/TED|This group represents those subjects who either participated in Study CL0600-020 (NCT00798967) and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension study CL0600-021 (NCT00930644) directly.
760351|NCT01560403|E2|Reported Event|TED/TED|This group represents those subjects exposed to active treatment with teduglutide for 24 weeks in Study CL0600-020 (NCT00798967) and an additional 24 months in Study CL0600-021 (NCT00930644)
760352|NCT01560403|E1|Reported Event|NT/PBO,TED|This group represents those subjects who either participated in Study CL0600-020 and received placebo, or who were eligible for randomization in Study CL0600-020 (NCT00798967), but qualified after the enrollment number was already satisfied and therefore entered the open-label extension Study CL0600-021 (NCT00930644) directly
760353|NCT01560260|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
760354|NCT01560260|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
760355|NCT01560260|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
760356|NCT01560260|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Linsitinib: Given PO~Pharmacological Study: Correlative studies"
760357|NCT01560234|B9|Baseline|Total|Total of all reporting groups
760358|NCT01560234|B8|Baseline|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760359|NCT01560234|B7|Baseline|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760360|NCT01560234|B6|Baseline|Cohort 5|AZD8848 15 μg
760361|NCT01560234|B5|Baseline|Cohort 4|AZD8848 5 μg
760362|NCT01560234|B4|Baseline|Cohort 3|AZD8848 1.5 μg
760363|NCT01560234|B3|Baseline|Cohort 2|AZD8848 0.5 ug
760364|NCT01560234|B2|Baseline|Cohort 1|AZD8848 0.15 μg
760365|NCT01560234|B1|Baseline|Placebo|Commercial 0.9% sodium chloride solution.
760366|NCT01560234|P8|Participant Flow|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760367|NCT01560234|P7|Participant Flow|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760368|NCT01560234|P6|Participant Flow|Cohort 5|AZD8848 15 μg
760369|NCT01560234|P5|Participant Flow|Cohort 4|AZD8848 5 μg
760370|NCT01560234|P4|Participant Flow|Cohort 3|AZD8848 1.5 μg
760371|NCT01560234|P3|Participant Flow|Cohort 2|AZD8848 0.5 ug
760372|NCT01560234|P2|Participant Flow|Cohort 1|AZD8848 0.15 μg
760373|NCT01560234|P1|Participant Flow|Placebo|Commercial 0.9% sodium chloride solution.
760374|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760382|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760383|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760384|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
760385|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
760386|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
760406|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760407|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760408|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
760409|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
760410|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
760411|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
760412|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
760413|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
760414|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760415|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760416|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
760417|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
760418|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
760419|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
760420|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
760421|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
760422|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760423|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760424|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
760425|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
760426|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
760427|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
760428|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
760429|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
760430|NCT01560234|O8|Outcome|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760431|NCT01560234|O7|Outcome|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760432|NCT01560234|O6|Outcome|Cohort 5|AZD8848 15 μg
760433|NCT01560234|O5|Outcome|Cohort 4|AZD8848 5 μg
760434|NCT01560234|O4|Outcome|Cohort 3|AZD8848 1.5 μg
760435|NCT01560234|O3|Outcome|Cohort 2|AZD8848 0.5 ug
760436|NCT01560234|O2|Outcome|Cohort 1|AZD8848 0.15 μg
760437|NCT01560234|O1|Outcome|Placebo|Commercial 0.9% sodium chloride solution.
760438|NCT01560234|E8|Reported Event|Cohort 6 and 8|AZD8848 30 μg (similar investigational product administration conditions)
760439|NCT01560234|E7|Reported Event|Cohort 7|AZD8848 15 μg (Multiple Inhalation)
760440|NCT01560234|E6|Reported Event|Cohort 5|AZD8848 15 μg
760441|NCT01560234|E5|Reported Event|Cohort 4|AZD8848 5 μg
760442|NCT01560234|E4|Reported Event|Cohort 3|AZD8848 1.5 μg
760443|NCT01560234|E3|Reported Event|Cohort 2|AZD8848 0.5 ug
760444|NCT01560234|E2|Reported Event|Cohort 1|AZD8848 0.15 μg
760445|NCT01560234|E1|Reported Event|Placebo|Commercial 0.9% sodium chloride solution.
760446|NCT01560143|B1|Baseline|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
760447|NCT01560143|P1|Participant Flow|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
760448|NCT01560143|O1|Outcome|Serum AUC of Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
760449|NCT01560143|E1|Reported Event|Tigecycline|"All subjects receive a single dose of tigecycline~Tigecycline: 100 mg IV as a single infusion over 30 minutes"
760450|NCT01559935|B1|Baseline|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
772884|NCT01500317|O3|Outcome|Placebo|Placebo tid
760451|NCT01559935|P1|Participant Flow|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
760452|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
760480|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
760481|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
760482|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
760453|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
760454|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
760455|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
760456|NCT01559935|O1|Outcome|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
760457|NCT01559935|E1|Reported Event|Car-BiRD Therapy|"Carfilzomib, Clarithromycin (Biaxin®), Lenalidomide (Revlimid®), and Dexamethasone (Decadron®) [Car-BiRD]~Car Phase:~carfilzomib: 45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles. Dexamethasone: 20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.~BiRD Phase:~Clarithromycin: 500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Lenalidomide: 25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Dexamethasone: 40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.~Maintenance Phase:~Lenalidomide: 10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed."
760458|NCT01559922|B3|Baseline|Total|Total of all reporting groups
760459|NCT01559922|B2|Baseline|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
760460|NCT01559922|B1|Baseline|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
760461|NCT01559922|P2|Participant Flow|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
760462|NCT01559922|P1|Participant Flow|Placebo|Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart
760463|NCT01559922|O2|Outcome|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
760464|NCT01559922|O1|Outcome|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
760465|NCT01559922|E2|Reported Event|Artefill|Artefill: Administration of up to 2 study treatments administered 6 weeks apart
772885|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
760466|NCT01559922|E1|Reported Event|Placebo|"Normal Saline~Normal Saline: Administration of up to 2 study treatments administered 6 weeks apart"
760467|NCT01559857|B3|Baseline|Total|Total of all reporting groups
760468|NCT01559857|B2|Baseline|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
760469|NCT01559857|B1|Baseline|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
760470|NCT01559857|P2|Participant Flow|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
760471|NCT01559857|P1|Participant Flow|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
760472|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
760473|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
760474|NCT01559857|O2|Outcome|Placebo - IS|Participants who received placebo and were insulin sensitive.
760475|NCT01559857|O1|Outcome|Pio - IS|Participants who received pioglitazone and were insulin sensitive.
760476|NCT01559857|O4|Outcome|Placebo - IR|Participants who received the sugar pill and were insulin resistant.
760477|NCT01559857|O3|Outcome|Pio - IR|Participants who received pioglitazone and were insulin resistant.
813195|NCT01349829|E1|Reported Event|HAVpur - First Vaccination|
760484|NCT01559857|E2|Reported Event|Sugar Pill|"50% of participants will be randomized to 12 weeks of treatment with placebo pill.~Sugar Pill: Placebo"
760485|NCT01559857|E1|Reported Event|Pioglitazone|"50% of participants will be allocated to 12 weeks of treatment with 30 mg/day of Pioglitazone.~Pioglitazone: 30mg once daily for 12 weeks"
760486|NCT01559844|B1|Baseline|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760487|NCT01559844|P1|Participant Flow|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet once daily + ribavirin (RBV) tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760488|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760489|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760490|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760491|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760492|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760493|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760494|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760495|NCT01559844|O1|Outcome|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760496|NCT01559844|E1|Reported Event|SOF+RBV|SOF 400 mg tablet once daily + RBV tablets (1000-1200 mg daily based on weight) for up to 48 weeks or until time of transplant, whichever occured first.
760497|NCT01559675|B3|Baseline|Total|Total of all reporting groups
760498|NCT01559675|B2|Baseline|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
760499|NCT01559675|B1|Baseline|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
760521|NCT01559506|B2|Baseline|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
760522|NCT01559506|B1|Baseline|No Device|Subject does not receive ABS system
760523|NCT01559506|P2|Participant Flow|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
760524|NCT01559506|P1|Participant Flow|No Device|Subject does not receive ABS system
772886|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
760500|NCT01559675|P2|Participant Flow|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
760501|NCT01559675|P1|Participant Flow|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
760502|NCT01559675|O2|Outcome|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
760503|NCT01559675|O1|Outcome|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
760504|NCT01559675|E2|Reported Event|Low Dose Steroid|"1/3 Intravenous equivalent dose (IVED) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed~Hydrocortisone: 1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed"
760505|NCT01559675|E1|Reported Event|High Dose Steroid|"Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed~Hydrocortisone: Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed"
760506|NCT01559649|B3|Baseline|Total|Total of all reporting groups
760507|NCT01559649|B2|Baseline|Nurses|Registered nurses working on MEDVAMC stroke wards
760508|NCT01559649|B1|Baseline|Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke.
760509|NCT01559649|P2|Participant Flow|Registered Nurses|Stroke ward nurses. The nurses administered and interpret the swallowing screening items. Speech pathologists made blinded, simultaneous interpretations of the screening items. Nurse and speech pathologist interpretation were used to establish nursing reliability.
760510|NCT01559649|P1|Participant Flow|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke recruited. Individuals with a history of neurological disease other than stroke, head and neck structural surgery, or history of dysphagia unrelated to the current stroke were excluded . Individuals who were obtunded, medically unstable, greater than 5 days post-admission were excluded. Patients with language or cognitive deficits who were judged by the attending neurologist to not have capacity to provide informed consent were eligible to participate, but they had to have an authorized representative available within 24 hours of admission to provide consent. Patients underwent swallowing screening and videofluoroscopic swallowing study (VFSS) to establish validity of screening items
760511|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
760512|NCT01559649|O1|Outcome|Nurses|Only nurses administered and interpreted the screening items.
760513|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses
760514|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
760515|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
760516|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
760517|NCT01559649|O2|Outcome|Registered Nurses|Stroke ward nurses.
760518|NCT01559649|O1|Outcome|Patients With Suspected Stroke|Veterans admitted to MEDVAMC with a suspected ischemic or hemorrhagic stroke
760519|NCT01559649|E1|Reported Event|Patients With Suspected Stroke|Individuals admitted with suspected ischemic or hemorrhagic stroke
760520|NCT01559506|B3|Baseline|Total|Total of all reporting groups
761262|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
760525|NCT01559506|O2|Outcome|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
760526|NCT01559506|O1|Outcome|No Device|Subject does not receive ABS system
760527|NCT01559506|E2|Reported Event|Air Barrier System Device|"Device is deployed adjacent to the surgery site and activated.~Air Barrier System device: Device is deployed adjacent to the surgery site and activated."
760528|NCT01559506|E1|Reported Event|No Device|Subject does not receive ABS system
760529|NCT01559454|B3|Baseline|Total|Total of all reporting groups
760530|NCT01559454|B2|Baseline|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760531|NCT01559454|B1|Baseline|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760532|NCT01559454|P2|Participant Flow|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760533|NCT01559454|P1|Participant Flow|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760534|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760535|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760536|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760537|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760538|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760539|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760540|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760541|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760542|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760543|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760544|NCT01559454|O2|Outcome|Buprenorphine/Naloxone|"4-16 mg/day divided by 2-4 times a day~Buprenorphine/naloxone: 4-16 mg/day divided by 2-4 times a day for 6 months"
760545|NCT01559454|O1|Outcome|Methadone|"10-60 mg/day divided by 2-4 times a day~Methadone: 10-60 mg/day divided by 2-4 times a day for 6 months"
760546|NCT01559454|E2|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg/day divided 2-4 times a day for 6 months
760547|NCT01559454|E1|Reported Event|Methadone|Methadone 10-60 mg/day divided 2-4 times a day for 6 months
760548|NCT01559311|B4|Baseline|Total|Total of all reporting groups
760549|NCT01559311|B3|Baseline|DDDR|Control Group – DDDR Standard Therapy
760550|NCT01559311|B2|Baseline|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
760551|NCT01559311|B1|Baseline|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
760552|NCT01559311|P3|Participant Flow|DDDR|Control Group – DDDR Standard Therapy
760553|NCT01559311|P2|Participant Flow|CRT-P ON|Echo-guided Group – Cardiac resynchronization therapy pacemaker (CRT-P) Standard Therapy
760554|NCT01559311|P1|Participant Flow|CRT-P OFF|Echo-guided Group – Dual chamber pacemaker (DDDR) Standard Therapy
760555|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
760556|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
760557|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
760558|NCT01559311|O3|Outcome|DDDR|Control Group – DDDR Standard Therapy
760559|NCT01559311|O2|Outcome|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
760560|NCT01559311|O1|Outcome|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
760561|NCT01559311|E3|Reported Event|DDDR|Control Group – DDDR Standard Therapy
760562|NCT01559311|E2|Reported Event|CRT-P ON|Echo-guided Group – CRT-P Standard Therapy
760563|NCT01559311|E1|Reported Event|CRT-P OFF|Echo-guided Group – DDDR Standard Therapy
760564|NCT01559116|B1|Baseline|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
760565|NCT01559116|P1|Participant Flow|All Subjects|Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 μg, 5/5 μg), tiotropium (2.5 μg, 5 μg) and olodaterol (5 μg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD) [VIVACITOTM].
760566|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760567|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760568|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760569|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760570|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
761263|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
760571|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760572|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760573|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760574|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760575|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760576|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760577|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760578|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760579|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760580|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760581|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760582|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
813542|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
760583|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760584|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760585|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760586|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760587|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760588|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760589|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760590|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760591|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760592|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760593|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760594|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760595|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760596|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760597|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760598|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760599|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760600|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760601|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760602|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760603|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760604|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760605|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760606|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760607|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.)
761264|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
760608|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760609|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760610|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760611|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760612|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760613|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760614|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760615|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760616|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760617|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760618|NCT01559116|O2|Outcome|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760619|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760620|NCT01559116|O6|Outcome|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760621|NCT01559116|O5|Outcome|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760622|NCT01559116|O4|Outcome|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760623|NCT01559116|O3|Outcome|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760624|NCT01559116|O2|Outcome|Olodaterol (5 µg)|"Olodaterol solution for inhalation - RESPIMAT~2 oral inhalations once daily in the morning for 6 weeks."
760625|NCT01559116|O1|Outcome|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT:2 Oral inhalations once daily in the morning for 6 weeks.
760626|NCT01559116|E6|Reported Event|Tiotropium+Olodaterol FDC (5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760627|NCT01559116|E5|Reported Event|Tiotropium+Olodaterol FDC (2.5/5 µg)|Tiotropium + Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760628|NCT01559116|E4|Reported Event|Tiotropium (5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760629|NCT01559116|E3|Reported Event|Tiotropium (2.5 µg)|Tiotropium solution for inhalation - RESPIMAT : 2 oral inhalations once daily in the morning for 6 weeks.
760630|NCT01559116|E2|Reported Event|Olodaterol (5 µg)|Olodaterol solution for inhalation – RESPIMAT: 2 oral inhalations once daily in the morning for 6 weeks.
760631|NCT01559116|E1|Reported Event|Placebo|Placebo matching Tiotropium+Olodaterol fixed dose combination (FDC) solution for inhalation – RESPIMAT: 2 Oral inhalations once daily in the morning for 6 weeks.
760632|NCT01559064|B4|Baseline|Total|Total of all reporting groups
760633|NCT01559064|B3|Baseline|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760634|NCT01559064|B2|Baseline|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760635|NCT01559064|B1|Baseline|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760636|NCT01559064|P3|Participant Flow|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760637|NCT01559064|P2|Participant Flow|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760638|NCT01559064|P1|Participant Flow|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760639|NCT01559064|O3|Outcome|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760640|NCT01559064|O2|Outcome|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760641|NCT01559064|O1|Outcome|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760642|NCT01559064|E3|Reported Event|Age Group C|"Subjects over 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760643|NCT01559064|E2|Reported Event|Age Group B|"Subjects 40 to 50 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760644|NCT01559064|E1|Reported Event|Age Group A|"Subjects 30 to 40 years old~Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®) : All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use."
760645|NCT01559012|B3|Baseline|Total|Total of all reporting groups
760646|NCT01559012|B2|Baseline|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
760647|NCT01559012|B1|Baseline|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
760648|NCT01559012|P2|Participant Flow|Placebo First - Clonidine Second|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
760649|NCT01559012|P1|Participant Flow|Clonidine First - Placebo Second|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
760650|NCT01559012|O2|Outcome|Placebo|diastolic blood pressure was recorded every day during placebo cycle
760651|NCT01559012|O1|Outcome|Clonidine|diastolic blood pressure was recorded every day during clonidine treatment cycle
760652|NCT01559012|O2|Outcome|Placebo|systolic blood pressure was recorded during placebo cycle
760653|NCT01559012|O1|Outcome|Clonidine|systolic blood pressure was recorded during clonidine treatment cycle
760654|NCT01559012|O2|Outcome|APGAR Score at 5'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
760723|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
760655|NCT01559012|O1|Outcome|APGAR Score at 1'|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
760656|NCT01559012|O1|Outcome|Mean Birth Weight of 12 Patients|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
760657|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
760658|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
760659|NCT01559012|O2|Outcome|Placebo|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
760660|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round.
760661|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
760662|NCT01559012|O1|Outcome|Clonidine|All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round
760663|NCT01559012|O2|Outcome|Placebo|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
760664|NCT01559012|O1|Outcome|Clonidine|"All patients were treated with TD clonidine for 5 days and switched to placebo for 5 days, or the other way round~Allocation order randomized"
760665|NCT01559012|O2|Outcome|Placebo|"in this group patients are treated with placebo first for 5 days then with TD clonidine for next 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
760666|NCT01559012|O1|Outcome|Clonidine|"in this group patients are treated with TD clonidine first for 5 days then switch to placebo for 5 days~Clonidine : transdermal clonidine patch 5 mg q. 5 days"
760667|NCT01559012|O2|Outcome|Placebo|"Six patients are treated with TD clonidine first,for 5 days, then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized~Every patient is the comparison as to herself"
760668|NCT01559012|O1|Outcome|Clonidine|"Six patients are treated with TD clonidine first for 5 days then switch to placebo for next 5 days Other six patients are treated with placebo first, for 5 days, then are switched to TD clonidine for next 5 days.~The allocation order for every patient is randomized.~Every patient is the comparison as to herself"
760669|NCT01559012|E2|Reported Event|Placebo|patients are treated with placebo (sham patch) for 5 days
760670|NCT01559012|E1|Reported Event|Clonidine|patients are treated with transdermal clonidine patch 5 mg for 5 days
760671|NCT01558791|B3|Baseline|Total|Total of all reporting groups
760672|NCT01558791|B2|Baseline|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
760673|NCT01558791|B1|Baseline|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
760674|NCT01558791|P2|Participant Flow|TBI Handout|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
760675|NCT01558791|P1|Participant Flow|Screened as Usual|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
760676|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
760677|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
760678|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
760679|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
760680|NCT01558791|O2|Outcome|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
760681|NCT01558791|O1|Outcome|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
760682|NCT01558791|E2|Reported Event|Arm 2|"Participants will be given the TBI handout (educational intervention) along with the usual TBI screen.~TBI handout: The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover."
760683|NCT01558791|E1|Reported Event|Arm 1|"Participants will be screened as usual. These participants will have the TBI screening as usual, without the educational intervention."
760684|NCT01558739|B1|Baseline|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760685|NCT01558739|P1|Participant Flow|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760686|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760687|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760688|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760689|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760690|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760691|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760692|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760693|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760694|NCT01558739|O1|Outcome|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760695|NCT01558739|E1|Reported Event|INC424|Patients diagnosed with PMF, PPV MF, or PET-MF were treated with oral INC424 at a dose of 15 - 20 mg (dose based on Baseline platelet count) twice daily.
760696|NCT01558700|B3|Baseline|Total|Total of all reporting groups
760697|NCT01558700|B2|Baseline|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
760698|NCT01558700|B1|Baseline|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
760699|NCT01558700|P2|Participant Flow|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
760700|NCT01558700|P1|Participant Flow|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
760701|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
760702|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
760703|NCT01558700|O2|Outcome|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
760704|NCT01558700|O1|Outcome|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
760705|NCT01558700|E2|Reported Event|Sugar Pill|"Matching capsule given once a day for a total of 17 weeks.~Sugar pill: Matching capsule given once a day for a total of 17 weeks."
760706|NCT01558700|E1|Reported Event|Duloxetine|"Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.~Duloxetine: Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week."
760707|NCT01558674|B3|Baseline|Total|Total of all reporting groups
760708|NCT01558674|B2|Baseline|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
761265|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
760709|NCT01558674|B1|Baseline|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
760710|NCT01558674|P2|Participant Flow|Furosemide/Torsemide→MK-7145 10 mg→MK-7145 16 mg→MK-7145 24 mg|Part 2: Participants receive Furosemide/Torsemide for 2 weeks , then 10 mg MK-7145 for 14 days, then MK-7145 16 mg for 14 days and then MK-7145 24 mg for 28 days. Each treatment period was separated by a 3-day wash-out.
760711|NCT01558674|P1|Participant Flow|MK-7145 8 mg→Furosemide 40 mg 2 x Day (BID)→ MK-7145 16 mg|Part 1: Participants receive 8 mg MK-7145 once daily (QD) for 5 days, then furosemide 40 mg BID for 5 days and then 16 mg MK-7145 QD for 5 days. Each treatment period was separated by a 3-day wash-out.
760712|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
760713|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
760714|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
760715|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
760716|NCT01558674|O2|Outcome|MK-7145 16 mg|14 mg of MK-7145 once daily for 14 days
760717|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
760718|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
760719|NCT01558674|O2|Outcome|MK-7145 16 mg|14 mg of MK-7145 once daily for 14 days
760720|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
760721|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
760722|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
760724|NCT01558674|O3|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
760725|NCT01558674|O2|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
760726|NCT01558674|O1|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
760727|NCT01558674|O4|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
760728|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
760729|NCT01558674|O2|Outcome|MK-7145 10 mg (Part 2:Period 2)|10 mg of MK-7145 once daily for 14 days
760730|NCT01558674|O1|Outcome|Furosemide/Torsemide (Part 2; Period 1)|Stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks.
760731|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760732|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760733|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760734|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760735|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760736|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760737|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760738|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760739|NCT01558674|O2|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760740|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760741|NCT01558674|O3|Outcome|MK-7145 16 mg (Part I:Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760742|NCT01558674|O2|Outcome|Furosemide 40 mg BID (Part 1: Period 2)|40 mg Furosemide tablet BID for 5 days administered in a fasted state
760743|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760744|NCT01558674|O4|Outcome|MK-7145 24 mg (Part 2: Period 4)|24 mg of MK-7145 once daily for 28 days
760745|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 2: Period 3)|14 mg of MK-7145 once daily for 14 days
760746|NCT01558674|O2|Outcome|MK-7145 10 mg (Part 2: Period 2)|10 mg of MK-7145 once daily for 14 days
760747|NCT01558674|O1|Outcome|Furosemide/Torsemide (Part 2; Period 1)|Stable, clinically optimized maintenance dose regimen of furosemide or torsemide for at least 2 weeks.
760748|NCT01558674|O3|Outcome|MK-7145 16 mg (Part 1: Period 3)|16 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760749|NCT01558674|O2|Outcome|Furosemide 40 mg BID (Part 1: Period 2)|40 mg Furosemide tablet BID for 5 days administered in a fasted state
760750|NCT01558674|O1|Outcome|MK-7145 8 mg (Part 1: Period 1)|8 mg MK-7145 QD for 5 days, capsules, orally administered in a fasted state
760751|NCT01558674|E3|Reported Event|Post Trial|Participants who received at least one dose of study drug during Period 1 or 2 of Part 1 of the study
760752|NCT01558674|E2|Reported Event|Furosemide 40 mg (Part 1:Period 2)|Two daily doses of one 40 mg Furosemide tablet for 5 days administered in a fasted state
760753|NCT01558674|E1|Reported Event|MK-7145 8 mg (Part 1:Period 1)|Single daily dose of 8 mg MK-7145 for 5 days, capsules, orally administered in a fasted state
760754|NCT01558596|B3|Baseline|Total|Total of all reporting groups
760789|NCT01558271|B3|Baseline|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760790|NCT01558271|B2|Baseline|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
761891|NCT01552876|E1|Reported Event|Etafilcon A|Those subjects who wore etafilcon A. (Phase I & II)
760755|NCT01558596|B2|Baseline|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
760756|NCT01558596|B1|Baseline|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
760757|NCT01558596|P2|Participant Flow|RIPC|"Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.~Preconditioning: Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion."
760758|NCT01558596|P1|Participant Flow|Sham|"Blood pressure cuff inflated to 40-50 mmHg in the upper extremity~Control: Blood pressure cuff inflated to 40-50 mmHg in the upper extremity"
760759|NCT01558596|O2|Outcome|RIPC|Blood pressure cuff inflated to 200 mmHg over the brachial artery while confirming absence of radial and ulnar pulse. Total duration of protocol was 30 minutes, equally divided between reperfusion and ischemia.
760760|NCT01558596|O1|Outcome|Sham|Blood pressure cuff inflated to 40-50 mmHg over brachial artery
813543|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
760761|NCT01558596|E2|Reported Event|RIPC|Blood pressure cuff inflated above systolic blood pressure (200 mmHg) over brachial artery to induce forearm ischemia. Total duration of protocol 30 minutes equally divided between ischemia ( 5 minutes x 3) and reperfusion ( 5 minutes x3)
760762|NCT01558596|E1|Reported Event|Sham|Blood pressure cuff inflated to 40 mmHg to mask controls
760763|NCT01558492|B1|Baseline|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
760764|NCT01558492|P1|Participant Flow|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
760765|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
760766|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
760767|NCT01558492|O1|Outcome|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
760768|NCT01558492|E1|Reported Event|All Subjects|"Carboplatin and Paclitaxel~Carboplatin: AUC = 5 intravenously (IV) on day 1 of a 28 day cycle~Paclitaxel: 80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle"
760769|NCT01558297|B4|Baseline|Total|Total of all reporting groups
760770|NCT01558297|B3|Baseline|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
760771|NCT01558297|B2|Baseline|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
760772|NCT01558297|B1|Baseline|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
760773|NCT01558297|P3|Participant Flow|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
760774|NCT01558297|P2|Participant Flow|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
760775|NCT01558297|P1|Participant Flow|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
760776|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
760777|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
760778|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
760779|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
760780|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
760781|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
760782|NCT01558297|O3|Outcome|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
760783|NCT01558297|O2|Outcome|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
760784|NCT01558297|O1|Outcome|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
760785|NCT01558297|E3|Reported Event|Treatment as Usual|Treatment as usual with primary care physician: Participants will be encouraged to continue their care with their primary care physician.
760786|NCT01558297|E2|Reported Event|Nutritional Counseling|Nutritional Counseling: 5 sessions of nutritional counseling over a period of 3 months.
760787|NCT01558297|E1|Reported Event|Motivational Interviewing|Motivational Interviewing: 5 sessions of motivational interviewing over a period of 3 months.
760788|NCT01558271|B4|Baseline|Total|Total of all reporting groups
760791|NCT01558271|B1|Baseline|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760792|NCT01558271|P3|Participant Flow|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760793|NCT01558271|P2|Participant Flow|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760794|NCT01558271|P1|Participant Flow|LY2189265|Once-weekly subcutaneous (SC) injection of 0.75 milligrams (mg) of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760795|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760796|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760797|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760798|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760799|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
813688|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
760800|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760801|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760802|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760803|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760804|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760805|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760806|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760807|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760808|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760809|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760810|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760811|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760812|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760813|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760814|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760815|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760816|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760817|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760818|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760819|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760820|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760932|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
760821|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760822|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760823|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760824|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760825|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760826|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760827|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760828|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760829|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
761373|NCT01556594|E3|Reported Event|High Dose Novel Form'n|high dose novel formulation
760830|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760831|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760832|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760833|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760834|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760835|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760836|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760837|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760838|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760839|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760840|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760841|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760842|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760843|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760844|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760845|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760846|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760847|NCT01558271|O2|Outcome|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760848|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760849|NCT01558271|O3|Outcome|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 24 weeks of open therapy.
760850|NCT01558271|O2|Outcome|Placebo|Once-weekly SC injection of placebo for 26 weeks of blinded therapy.
760851|NCT01558271|O1|Outcome|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy.
760933|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
772887|NCT01500317|E3|Reported Event|Placebo|Placebo tid
760852|NCT01558271|E3|Reported Event|Liraglutide|Once-daily SC injection of 0.3 mg of Liraglutide for the first week, followed by 0.6 mg of Liraglutide for the second week, and then 0.9 mg of Liraglutide for the remaining 50 weeks of open therapy.
760853|NCT01558271|E2|Reported Event|Placebo/LY2189265|Once-weekly SC injection of placebo for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760854|NCT01558271|E1|Reported Event|LY2189265|Once-weekly SC injection of 0.75 mg of LY2189265 for 26 weeks of blinded therapy, followed by once-weekly SC injection of 0.75 mg LY2189265 for an additional 26 weeks of open therapy.
760855|NCT01558128|B1|Baseline|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
760856|NCT01558128|P1|Participant Flow|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
760942|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
760857|NCT01558128|O1|Outcome|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
760858|NCT01558128|E1|Reported Event|Amiodarone With Cardioversion|"If subject converts to normal sinus rhythm following amiodarone no further intervention is taken, if subject remains in atrial fibrillation following amiodarone they are cardioverted.~Amiodarone: Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.~Cardioversion: Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol."
760859|NCT01558089|B1|Baseline|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
760860|NCT01558089|P1|Participant Flow|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
760861|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760862|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760863|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760864|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760865|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760866|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760867|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760868|NCT01558089|O1|Outcome|Etanercept/Methotrexate|All participants in this study who received Etanercept and Methotrexate
760869|NCT01558089|E1|Reported Event|ETANERCEPT/ METHOTREXATE|The study group comprised adult patients who at the time of entry had moderate-to-severe rheumatoid arthritis (RΑ), having symptoms for at least 6 weeks and no more than 2 years while satisfying the 2010 RA classification criteria, Disease Activity Score 28 (DAS28) ≥3.2, and who were prescribed for the first time to receive Methotrexate + Etanercept according to routine clinical practice and current summary of product characteristics, prior to enrollment in this study.
760870|NCT01557959|B1|Baseline|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
760871|NCT01557959|P1|Participant Flow|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
760872|NCT01557959|O1|Outcome|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
760934|NCT01557868|E2|Reported Event|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
760935|NCT01557868|E1|Reported Event|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
760936|NCT01557842|B3|Baseline|Total|Total of all reporting groups
760873|NCT01557959|E1|Reported Event|Treatment (Chemo, Chemoprotection, Antiangiogenesis Therapy)|Patients receive docetaxel IV over 1 hour on day 1, cisplatin IV over 1 hour on day 1, and pegfilgrastim subcutaneously on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Beginning 2 weeks after completion of docetaxel, cisplatin, and pegfilgrastim, patients receive oral erlotinib hydrochloride once daily in the absence of disease progression or unacceptable toxicity.
760874|NCT01557920|B1|Baseline|Crossover Randomized Propofol and Sevoflurane|"The healthy subject will be anesthetized with Propofol and Sevoflurane in a randomized crossover fashion. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Spontaneous swallows were identified, and categorized as physiological or pathological. Physiological swallows were followed by expiratory flow (E or I–E). Pathological swallows were followed by inspiration (I and E–I).~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
760943|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
760875|NCT01557920|P2|Participant Flow|Sevoflurane First, Then Propofol|"The healthy subject will be anesthetized first with Sevoflurane, and secondarily with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
760876|NCT01557920|P1|Participant Flow|Propofol First, Then Sevoflurane|"The healthy subject will be anesthetized first with Propofol, and secondarily with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
760877|NCT01557920|O2|Outcome|Wakefulness|
760878|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane|
760879|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (during baseline CO2).
760880|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Duty cycle during anesthesia with propofol (CO2 baseline).
760881|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (baseline CO2)
760882|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Duty cycle during anesthesia with sevoflurane (during baseline CO2).
760883|NCT01557920|O1|Outcome|Wakefulness|Duty cycle (CO2 baseline)
760884|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (during baseline CO2).
760885|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|Minute Ventilation during anesthesia with propofol (CO2 baseline).
760886|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (baseline CO2)
760887|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|Minute ventilation during anesthesia with sevoflurane (during baseline CO2).
760888|NCT01557920|O1|Outcome|Wakefulness|Minute Ventilation (CO2 baseline)
760889|NCT01557920|O4|Outcome|Tonic Genioglossus Activity (Deep Anesthesia)|Tonic Genioglossus activity (deep anesthesia)
760890|NCT01557920|O3|Outcome|Phasic Genioglossus Activity (Deep Anesthesia)|Phasic activity (Peak activity - Tonic activity)
760891|NCT01557920|O2|Outcome|Tonic Genioglossus Activity (Light Anesthesia)|Tonic Genioglossus activity (light anesthesia)
760892|NCT01557920|O1|Outcome|Phasic Genioglossus Activity (Light Anesthesia)|Phasic activity (Peak activity - Tonic activity)
760893|NCT01557920|O5|Outcome|Anesthesia With High Dose Propofol (CO2 Baseline)|
760894|NCT01557920|O4|Outcome|Anesthesia With Low Dose Propofol (CO2 Baseline)|
760895|NCT01557920|O3|Outcome|Anesthesia With High Dose Sevoflurane (Baseline CO2)|
760896|NCT01557920|O2|Outcome|Anesthesia With Low Dose Sevoflurane (Baseline CO2)|
760897|NCT01557920|O1|Outcome|Wakefulness|
760898|NCT01557920|O6|Outcome|Wakefulness (With CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during wakefulness (with CO2+4 and +8 insufflation).
760899|NCT01557920|O5|Outcome|Wakefulness (During Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia (during baseline CO2).
760900|NCT01557920|O4|Outcome|Anesthesia With Propofol and Sevoflurane (CO2 Insufflation)|Proportion of pathological (inspiratory) swallows during anesthesia (with CO2+4 and +8 insufflation).
760901|NCT01557920|O3|Outcome|Anesthesia With Propofol and Sevoflurane (Baseline CO2)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (during baseline CO2).
760902|NCT01557920|O2|Outcome|Wakefulness (All Cases)|Proportion of pathological (inspiratory) swallows during wakefulness (across CO2 levels)
760903|NCT01557920|O1|Outcome|Anesthesia With Propofol and Sevoflurane (All Cases)|Proportion of pathological (inspiratory) swallows during anesthesia with propofol and sevoflurane (across carbon-dioxide (CO2) levels).
760937|NCT01557842|B2|Baseline|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
760967|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
772888|NCT01500317|E2|Reported Event|Oxycodone|5 mg oxycodone tid
760904|NCT01557920|O2|Outcome|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
760905|NCT01557920|O1|Outcome|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
760976|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
761374|NCT01556594|E2|Reported Event|Low Dose Novel Form'n|Low dose novel formulation
760906|NCT01557920|E2|Reported Event|Sevoflurane|"The healthy subject will be anesthetized with Sevoflurane. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Sevoflurane: Sevoflurane will be administered via mask inhalation to achieve anesthesia."
760907|NCT01557920|E1|Reported Event|Propofol|"The healthy subject will be anesthetized with Propofol. Respiratory measurements will be taken while the subject is anesthetized to calculate the airway closing pressure. After recovery from anesthesia, airway diameter and duty cycle will also be measured. In addition to breathing air mixture, subject will be given carbon dioxide to achieve end tidal CO2 levels of 4 mm and 8 mm above baseline. All respiratory measurements will be repeated at each level above baseline.~Propofol: Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump."
760908|NCT01557894|B3|Baseline|Total|Total of all reporting groups
760909|NCT01557894|B2|Baseline|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760910|NCT01557894|B1|Baseline|Waitlist Control Group|Wait-list control group
760911|NCT01557894|P2|Participant Flow|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760912|NCT01557894|P1|Participant Flow|Waitlist Control Group|"Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks.~Starting from week 10 these participants received the active intervention."
760913|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760914|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
760915|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760916|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
760917|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760918|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
760919|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760920|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group
760921|NCT01557894|O2|Outcome|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760922|NCT01557894|O1|Outcome|Waitlist Control Group|Wait-list control group just completed a weekly social anxiety measure (LSAS-SR) for the first 9 weeks. Starting from week 10 these participants benefited from the active intervention.
760923|NCT01557894|E2|Reported Event|iSOFIE|"Cognitive - Behavioral: Internet-administrated CBT for Social Phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)~iSOFIE : Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)"
760924|NCT01557894|E1|Reported Event|Waitlist Control Group|Wait-list control group
760925|NCT01557868|B3|Baseline|Total|Total of all reporting groups
760926|NCT01557868|B2|Baseline|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
760927|NCT01557868|B1|Baseline|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
760928|NCT01557868|P2|Participant Flow|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
760929|NCT01557868|P1|Participant Flow|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
760930|NCT01557868|O2|Outcome|Euflexxa (1% Sodium Hyaluronate)|1% sodium hyaluronate: Three 2 cc injections at weekly intervals
760931|NCT01557868|O1|Outcome|Synvisc (Hylan G-F 20)|hylan G-F 20: Three 2 cc injections at weekly intervals
760938|NCT01557842|B1|Baseline|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
760939|NCT01557842|P2|Participant Flow|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
760940|NCT01557842|P1|Participant Flow|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
760941|NCT01557842|O2|Outcome|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
760944|NCT01557842|O1|Outcome|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
760945|NCT01557842|E2|Reported Event|Drug Treatment Group|Subjects randomized to this arm were treated with Class I and III anti-arrhythmic medication alone. Determination of optimal medical therapy was at the discretion of the investigator.
760946|NCT01557842|E1|Reported Event|Catheter Ablation Group|Subjects were randomly allocated to treatment in a 1:1 fashion. Subjects randomized to this arm were treated with ventricular tachycardia ablation using the NAVISTAR THERMOCOOL Catheter in conjunction with Class I and III anti-arrhythmic medical therapy. Determination of optimal medical therapy was at the discretion of the investigator.
760947|NCT01557699|B4|Baseline|Total|Total of all reporting groups
760948|NCT01557699|B3|Baseline|Subcutaneous Meales Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760949|NCT01557699|B2|Baseline|PMV SoloventTM|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760950|NCT01557699|B1|Baseline|PMV Puffhaler®|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760951|NCT01557699|P3|Participant Flow|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760952|NCT01557699|P2|Participant Flow|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760953|NCT01557699|P1|Participant Flow|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760954|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760955|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760956|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760957|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760958|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760959|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760960|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760961|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760962|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760963|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760964|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760965|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760966|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
772889|NCT01500317|E1|Reported Event|Tapentadol|75 mg tapentadol tid
760968|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760969|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760970|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760971|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760972|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
760973|NCT01557699|O2|Outcome|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.~N=20"
760974|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760975|NCT01557699|O3|Outcome|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml was given subcutaneously.~N=20"
813692|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
760977|NCT01557699|O1|Outcome|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.~N=20"
760978|NCT01557699|O3|Outcome|Subcutaneous Meales Vaccine|Licensed Subcutaneous Measles Vaccine was administered as single dose of 0.5 ml subcutaneously
760979|NCT01557699|O2|Outcome|PMV SoloventTM|Dry Powdered Measles Vaccine: The vaccine was administered via SoloventTM device. A single dose of 10 mg was used.
760980|NCT01557699|O1|Outcome|PMV Puffhaler®|Dry Powdered Measles Vaccine: The vaccine was administered via a Puffhaler® device. A single dose of 10 mg was used.
760981|NCT01557699|E3|Reported Event|Licensed Subcutaneous Measles Vaccine|"Licensed Subcutaneous Measles Vaccine: This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.~N=20"
760982|NCT01557699|E2|Reported Event|Dry Powdered Measles Vaccine Via SoloventTM Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via SoloventTM device. A single dose of 10 mg will be used.~N=20"
760983|NCT01557699|E1|Reported Event|Dry Powdered Measles Vaccine Via a Puffhaler® Device|"Dry Powdered Measles Vaccine: The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg will be used.~N=20"
760984|NCT01555567|B5|Baseline|Total|Total of all reporting groups
760985|NCT01555567|B4|Baseline|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760986|NCT01555567|B3|Baseline|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760987|NCT01555567|B2|Baseline|Standard of Care|This group will undergo standard ACL rehabilitation
760988|NCT01555567|B1|Baseline|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
760989|NCT01555567|P4|Participant Flow|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760990|NCT01555567|P3|Participant Flow|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760991|NCT01555567|P2|Participant Flow|Standard of Care|This group will undergo standard ACL rehabilitation
760992|NCT01555567|P1|Participant Flow|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo neuromuscular electrical stimulation (NMES) following anterior cruciate ligament (ACLr). Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
761030|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761266|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
760993|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760994|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760995|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
760996|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
761036|NCT01557504|O2|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
814296|NCT01346475|B2|Baseline|High Dose Valacyclovir|
760997|NCT01555567|O4|Outcome|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760998|NCT01555567|O3|Outcome|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
760999|NCT01555567|O2|Outcome|Standard of Care|This group will undergo standard ACL rehabilitation
761000|NCT01555567|O1|Outcome|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
761001|NCT01555567|E4|Reported Event|Combination of NMES and Eccentric Exercise|"Subjects placed into this group will undergo a combined NMES and eccentric exercise intervention following ACLr. The NMES intervention will be delivered immediately following ACLr and will end at 6 weeks post-ACLr. Subjects will receive the NMES therapy 2 times per week for the first 6 weeks post-ACLr. At six weeks post-ACLr, subjects will begin the eccentric strengthening protocol. Subjects will eccentrically train 2 times per week for 6 weeks. The eccentric strengthening will end at 12 weeks post-ACLr.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
761002|NCT01555567|E3|Reported Event|Eccentric Exercise|"Subjects placed into this group will undergo eccentric exercise strength training following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr. Eccentric strengthening will begin at week 6 post-ACLr and will end at week 12 post-ACLr.~Eccentric Exercise: Eccentric Exercise will be delivered 2 times per week"
761003|NCT01555567|E2|Reported Event|Standard of Care|This group will undergo standard ACL rehabilitation
761004|NCT01555567|E1|Reported Event|Neuromuscular Electrical Stimulation|"Subjects placed into this group will undergo NMES following ACLr. Subjects will be required to report 2 times per week for 6 weeks following ACLr for NMES therapy. NMES therapy post-reconstruction will commence immediately post-ACLr and end at week 6.~Neuromuscular Electrical Stimulation: NMES will be delivered 2 times per week"
761005|NCT01557595|B1|Baseline|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
761006|NCT01557595|P1|Participant Flow|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited. Daily bedtime, wake-up time, and compliance diaries were used to assess sleep quality and timing during a baseline observation week and a 2-week intervention period. The Pittsburgh Sleep Quality Index (PSQI) was administered following baseline and intervention. The intervention protocol consisted of use of blue wavelength-blocking glasses and a moderate lighting environment during evening hours.
761007|NCT01557595|O1|Outcome|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
761008|NCT01557595|E1|Reported Event|Adults With ADHD|Participants age 19 and older with a diagnosis of ADHD, in a generally healthy medical condition were recruited.
761009|NCT01557582|B1|Baseline|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
761031|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761267|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
772890|NCT01500278|B3|Baseline|Total Title|
761010|NCT01557582|P1|Participant Flow|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
761011|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
761279|NCT01555463|P2|Participant Flow|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761012|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
761013|NCT01557582|O1|Outcome|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
761014|NCT01557582|E1|Reported Event|Right Ventrical Volume Comparison|"Single arm study comparing Ventripoint Medical System (VMS) right ventricle volume measurement to gold standard cardiac Magnetic Resonance Imaging (cMRI) measurement in patients with Pulmonary Arterial Hypertension.~Ventripoint Medical System: The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
761015|NCT01557569|B3|Baseline|Total|Total of all reporting groups
761016|NCT01557569|B2|Baseline|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
761017|NCT01557569|B1|Baseline|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
761018|NCT01557569|P2|Participant Flow|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
761019|NCT01557569|P1|Participant Flow|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
761020|NCT01557569|O2|Outcome|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
761021|NCT01557569|O1|Outcome|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
761022|NCT01557569|E2|Reported Event|Placebo|"Group will receive placebo instead of atomoxetine~placebo: participants in this group will receive 1 dose of placebo daily for the entire 10-weeks."
761023|NCT01557569|E1|Reported Event|Atomoxetine|"Group receiving atomoxetine~Atomoxetine: During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)"
761024|NCT01557504|B3|Baseline|Total|Total of all reporting groups
761025|NCT01557504|B2|Baseline|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761026|NCT01557504|B1|Baseline|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761027|NCT01557504|P2|Participant Flow|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761028|NCT01557504|P1|Participant Flow|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761029|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761032|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761033|NCT01557504|O2|Outcome|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761034|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761035|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761037|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761038|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761039|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761040|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761041|NCT01557504|O1|Outcome|Metformin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761042|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761043|NCT01557504|O1|Outcome|Sitagliptin|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761044|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 9.
761045|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 6.
761046|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 4.
761047|NCT01557504|O1|Outcome|All Treated Participants|All participants who completed at least one period of treatment and had available data. All participants received a single dose of two matching placebo tablets on Day 2.
761048|NCT01557504|E2|Reported Event|Placebo|Days 1-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761049|NCT01557504|E1|Reported Event|Sitagliptin/Metformin XR Followed by Placebo|Day 1 (Period 1): participants received a single dose of two sitagliptin/metformin XR tablets with a low- to moderate-fat meal (breakfast). Days 2-4 (Period 1): participants received a single dose of two matching placebo tablets. Days 5-9 (Period 2): participants received a single dose of two matching placebo tablets with the evening meal.
761050|NCT01557348|B3|Baseline|Total|Total of all reporting groups
761051|NCT01557348|B2|Baseline|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761052|NCT01557348|B1|Baseline|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761053|NCT01557348|P2|Participant Flow|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761054|NCT01557348|P1|Participant Flow|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761055|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761056|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761057|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761058|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761059|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761060|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761061|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761062|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761280|NCT01555463|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761063|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761064|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761065|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761066|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761067|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761068|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761069|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761070|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761071|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761072|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761073|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761074|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761075|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761076|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761077|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761078|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761079|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761080|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761081|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761082|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761083|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761084|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761085|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761086|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761268|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761087|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761088|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761089|NCT01557348|O2|Outcome|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761090|NCT01557348|O1|Outcome|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761091|NCT01557348|E2|Reported Event|Alternative TNFi|Eligible participants received alternative TNFi as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761092|NCT01557348|E1|Reported Event|Rituximab|Eligible participants received rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.
761093|NCT01557322|B3|Baseline|Total|Total of all reporting groups
761281|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761094|NCT01557322|B2|Baseline|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761095|NCT01557322|B1|Baseline|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761096|NCT01557322|P2|Participant Flow|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761097|NCT01557322|P1|Participant Flow|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761098|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761099|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761100|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761101|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761102|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761103|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761104|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761105|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761106|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761107|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761108|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761109|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761110|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761111|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761112|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761113|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761114|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761115|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761116|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761117|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761118|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761119|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761120|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761121|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761122|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761123|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761124|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761125|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761126|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761127|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761128|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761129|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761130|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761131|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761132|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761133|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761134|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761135|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761136|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761137|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761138|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761139|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761140|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761141|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761142|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761143|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761144|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761145|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761146|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761147|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761148|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761149|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761150|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761151|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761152|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761153|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761154|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761155|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761156|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761157|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761158|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761159|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761160|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761161|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761162|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761163|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761164|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761165|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761166|NCT01557322|O2|Outcome|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761167|NCT01557322|O1|Outcome|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761168|NCT01557322|E2|Reported Event|nbDMARDs|Biological naïve participants with moderate RA, defined as DAS28 >3.2 to <=5.1, who received non-biologic disease modifying anti-rheumatic drugs (nbDMARDs) in doses as per approved product label or SmPC, were followed retrospectively using the data in BSRBR for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761169|NCT01557322|E1|Reported Event|Etanercept|Participants with moderate rheumatoid arthritis (RA), defined as disease activity score based on 28-joints count (DAS28) more than (>) 3.2 to less than or equal to (<=) 5.1, who received etanercept (ETN, as their first biological drug) in doses as per approved product label or summary of product characteristics (SmPC), were followed retrospectively using the data in British Society for Rheumatology Biologics Register (BSRBR) for 5 years. The doses had been adjusted according to medical and therapeutic necessity.
761187|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761269|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761170|NCT01557283|B1|Baseline|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761171|NCT01557283|P1|Participant Flow|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761192|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761172|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761173|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761174|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761175|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761176|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761177|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761178|NCT01557283|O1|Outcome|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761179|NCT01557283|E1|Reported Event|Etanercept|Participants who had moderate to severe plaque psoriasis and received etanercept (Enbrel) as per Summary of Product Characteristics (SmPC), were observed for at least 1 year. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly subcutaneous injection. Participants either received etanercept in treatment cycles of up to 24 weeks with at least 2 weeks of treatment discontinuation between the cycles or continuously without any treatment discontinuation as per dermatologist’s discretion.
761180|NCT01557166|B3|Baseline|Total|Total of all reporting groups
761181|NCT01557166|B2|Baseline|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761182|NCT01557166|B1|Baseline|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761183|NCT01557166|P2|Participant Flow|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761184|NCT01557166|P1|Participant Flow|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761185|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761186|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
762721|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
761188|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761189|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761190|NCT01557166|O1|Outcome|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761191|NCT01557166|O2|Outcome|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761364|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
761193|NCT01557166|E2|Reported Event|Placebo|Subjects were administered placebo subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761194|NCT01557166|E1|Reported Event|Liraglutide 3.0 mg|Subjects were administered 3.0 mg of liraglutide subcutaneously (s.c., under the skin) once daily for 32 weeks. Subjects were also prescribed a 500 kcal/day-deficit diet and exercise for a minimum of 150 min/week.
761195|NCT01556997|B4|Baseline|Total|Total of all reporting groups
761196|NCT01556997|B3|Baseline|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
761197|NCT01556997|B2|Baseline|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
761198|NCT01556997|B1|Baseline|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
761199|NCT01556997|P3|Participant Flow|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
761200|NCT01556997|P2|Participant Flow|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
761201|NCT01556997|P1|Participant Flow|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
761202|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
761203|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
761204|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
761205|NCT01556997|O3|Outcome|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
761206|NCT01556997|O2|Outcome|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
761207|NCT01556997|O1|Outcome|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
761208|NCT01556997|E3|Reported Event|Perindopril Erbumine (PERe)|Perindopril Erbumine: PERe capsule taken once daily by mouth for six weeks
761209|NCT01556997|E2|Reported Event|Amlodipine Besylate (AMLb)|Amlodipine Besylate: AMLb capsule taken once daily by mouth for six weeks
761210|NCT01556997|E1|Reported Event|XOMA 985|"fixed-dose combination of perindopril arginine/amlodipine besylate(PERa/AMLb)~XOMA 985: PERa/AMLb capsule taken once daily by mouth for six weeks"
761211|NCT01556932|B1|Baseline|All Participants|"All participants go through Placebo-ABH or ABH-placebo depending on the sequence they were randomized to. Patients are randomized into Placebo-ABH or ABH-Placebo sequence.~Sequence 1:Patients apply Drug A gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug B. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug A. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol.~Sequence 2:Patients will apply Drug B gel topically for 2 minutes at time 0. After 1 hour, if no change or increase in the nausea score alternative treatment will be given Drug A. If the second treatment is ineffective at one hour (total time 2 hours) alternative usual medications will be given Drug B. ABH is Ativan (lorazepam), Benadryl (diphenhydramine), and Haldol."
761212|NCT01556932|P2|Participant Flow|Placebo-ABH Gel|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with Placebo first and then went to ABH gel. The randomization list will be generated by the Study Biostatistician.
761213|NCT01556932|P1|Participant Flow|ABH Gel- Placebo|All individuals who are eligible were randomized to a sequence of treatments: either placebo-ABH or ABH-placebo. All participants were on one arm but separate sequences because they started on different drugs. This group started with ABH gel first and then went to Placebo.The randomization list will be generated by the Study Biostatistician.
761214|NCT01556932|O2|Outcome|Placebo|Placebo applied topically for 2 minutes.
761215|NCT01556932|O1|Outcome|ABH Gel|ABH Gel applied topically for 2 minutes.
761216|NCT01556932|E1|Reported Event|Arm A and Arm B|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes and placebo topically over 2 minutes.
761217|NCT01556906|B1|Baseline|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761218|NCT01556906|P1|Participant Flow|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761219|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
763005|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
761220|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761221|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761222|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761223|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761224|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761225|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761226|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761227|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761228|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761229|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761230|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761231|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761232|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761233|NCT01556906|O1|Outcome|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761234|NCT01556906|E1|Reported Event|Lomitapide Escalated|Lomitapide initiated with an oral dose of 0.03 mg/kg/day for 4 weeks and then escalated through an additional 3 dose levels (0.1, 0.3, and 1.0 mg/kg/day) every 4 weeks over a 16-week period.
761235|NCT01556763|B4|Baseline|Total|Total of all reporting groups
761236|NCT01556763|B3|Baseline|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761237|NCT01556763|B2|Baseline|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761238|NCT01556763|B1|Baseline|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761239|NCT01556763|P3|Participant Flow|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761240|NCT01556763|P2|Participant Flow|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761241|NCT01556763|P1|Participant Flow|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761242|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761243|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761244|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761245|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761246|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761247|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761248|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761249|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761250|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761251|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761252|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761253|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761254|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761255|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761256|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761257|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761258|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761259|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761260|NCT01556763|O2|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761261|NCT01556763|O1|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
773036|NCT01499849|B3|Baseline|Total|Total of all reporting groups
761270|NCT01556763|O3|Outcome|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761271|NCT01556763|O2|Outcome|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761272|NCT01556763|O1|Outcome|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761273|NCT01556763|E3|Reported Event|EVP-6124 (0.3 mg/Day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
761274|NCT01556763|E2|Reported Event|EVP-6124 (1.0 mg/Day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
761275|NCT01556763|E1|Reported Event|Placebo|Matching placebo was administered as one capsule per day for 21 days.
761276|NCT01555463|B3|Baseline|Total|Total of all reporting groups
761277|NCT01555463|B2|Baseline|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761278|NCT01555463|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761282|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761283|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761284|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761285|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761286|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761287|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761288|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761289|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761290|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761291|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761292|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761293|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761294|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761295|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761296|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761297|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761298|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761299|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761300|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761301|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761302|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761303|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761304|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761305|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761306|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761307|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761308|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761309|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761310|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761311|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761312|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761313|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761314|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761315|NCT01555463|O2|Outcome|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761316|NCT01555463|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761317|NCT01555463|E2|Reported Event|Vehicle Foam|0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
761318|NCT01555463|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
761319|NCT01556724|B3|Baseline|Total|Total of all reporting groups
761320|NCT01556724|B2|Baseline|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761321|NCT01556724|B1|Baseline|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761322|NCT01556724|P2|Participant Flow|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761323|NCT01556724|P1|Participant Flow|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761324|NCT01556724|O2|Outcome|0.1% Ropivacaine|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761325|NCT01556724|O1|Outcome|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761351|NCT01556633|E2|Reported Event|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761352|NCT01556633|E1|Reported Event|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761353|NCT01556594|B4|Baseline|Total|Total of all reporting groups
761354|NCT01556594|B3|Baseline|Group 3|Med dose IN followed by SC injection followed by high dose IN of glucagon
761355|NCT01556594|B2|Baseline|Group 2|Low dose IN followed by med dose IN followed by SC injection followed by high dose IN of glucagon
761326|NCT01556724|E2|Reported Event|0.1% Ropivacaine Infusion in Nerve Block Catheter|"0.1% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761365|NCT01556594|O3|Outcome|High Dose Novel Form'n|high dose novel formulation
761366|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
761367|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
761368|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
761369|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
761370|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
761371|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
761372|NCT01556594|E4|Reported Event|Medium Dose Novel Form'n|Medium dose novel formulation
761327|NCT01556724|E1|Reported Event|0.2% Ropivacaine|"0.2% ropivacaine~Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2."
761328|NCT01556633|B3|Baseline|Total|Total of all reporting groups
761329|NCT01556633|B2|Baseline|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761330|NCT01556633|B1|Baseline|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761331|NCT01556633|P2|Participant Flow|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761332|NCT01556633|P1|Participant Flow|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761333|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761334|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761335|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance (CLCR) from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761336|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis (PD) using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761337|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761338|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761339|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761340|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761341|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761342|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761343|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761344|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761345|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761346|NCT01556633|O1|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761347|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761348|NCT01556633|O2|Outcome|Reduced Creatinine Clearance (Oseltamivir 30 mg)|Participants with creatinine clearance from 10 to 30 milliliter (mL)/minute (min) not on dialysis received a single oral dose of oseltamivir 30 mg capsule.
761349|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761350|NCT01556633|O1|Outcome|Dialysis (Oseltamivir 75 mg)|Participants on Peritoneal Dialysis using a rapid cycle regimen to simulate Automated Peritoneal Dialysis (APD) received a single oral dose of oseltamivir 75 mg capsule.
761356|NCT01556594|B1|Baseline|Group 1|Low dose IN followed by med dose IN followed by SC injection of glucagon
761357|NCT01556594|P3|Participant Flow|Gp 3: Med Dose IN, SC, High Dose IN|Med dose IN followed by SC followed by high dose IN glucagon
761358|NCT01556594|P2|Participant Flow|Gp 2: Low Dose IN, Med Dose IN, SC, High Dose IN|Low dose IN followed by medium dose IN followed by SC followed by high dose IN glucagon
761359|NCT01556594|P1|Participant Flow|Gp 1: Low Dose IN, Med Dose IN, SC|Low dose IN followed by med dose IN followed by SC injection of glucagon
761360|NCT01556594|O4|Outcome|Medium Dose Novel Form'n|Medium dose novel formulation
761361|NCT01556594|O3|Outcome|High Dose Novel Form'n|High dose novel formulation
761362|NCT01556594|O2|Outcome|Low Dose Novel Form'n|Low dose novel formulation
761363|NCT01556594|O1|Outcome|SC Glucagon Injection|SC glucagon injection 1 mg
761375|NCT01556594|E1|Reported Event|SC Glucagon Injection|SC glucagon injection 1 mg
761376|NCT01556451|B1|Baseline|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
761377|NCT01556451|P1|Participant Flow|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
761378|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
761379|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
761380|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
761381|NCT01556451|O1|Outcome|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
761382|NCT01556451|E1|Reported Event|Zoster Vaccine Live|Single subcutaneous injection of 0.65 mL in the deltoid region of arm on Day 1
761383|NCT01556204|B3|Baseline|Total|Total of all reporting groups
761384|NCT01556204|B2|Baseline|Laparoscopic|Laparoscopic surgery
761385|NCT01556204|B1|Baseline|Robotic|Robotic surgery
761386|NCT01556204|P2|Participant Flow|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761387|NCT01556204|P1|Participant Flow|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761388|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761389|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761417|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
761464|NCT01555151|P4|Participant Flow|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
777566|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
761390|NCT01556204|O2|Outcome|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761391|NCT01556204|O1|Outcome|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761423|NCT01555983|P6|Participant Flow|6.7%THC First, Then 2.9%THC, Then Placebo|6.7%THC in am of first intervention visit, then 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
761475|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761392|NCT01556204|E2|Reported Event|Laparoscopy|"Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761393|NCT01556204|E1|Reported Event|Robotic Surgery|"da Vinci Surgical System~Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis)."
761394|NCT01556165|B3|Baseline|Total|Total of all reporting groups
761395|NCT01556165|B2|Baseline|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
761396|NCT01556165|B1|Baseline|Placebo|placebo: tablets, once daily, orally
761397|NCT01556165|P2|Participant Flow|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
761398|NCT01556165|P1|Participant Flow|Placebo|placebo: tablets, once daily, orally
761399|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
761400|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
761401|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
761402|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
761403|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
761404|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
761405|NCT01556165|O2|Outcome|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
761406|NCT01556165|O1|Outcome|Placebo|placebo: tablets, once daily, orally
761407|NCT01556165|E2|Reported Event|Rasagiline|rasagiline: 1 mg/day, tablets, once daily, orally
761408|NCT01556165|E1|Reported Event|Placebo|placebo: tablets, once daily, orally
761409|NCT01556061|B3|Baseline|Total|Total of all reporting groups
761410|NCT01556061|B2|Baseline|D-MAC First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
761411|NCT01556061|B1|Baseline|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
761412|NCT01556061|P2|Participant Flow|D-MAC First, Then CMAC Video Laryngoscopy|D-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
761413|NCT01556061|P1|Participant Flow|C-MAC First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
761414|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
761415|NCT01556061|O1|Outcome|C-MAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
761416|NCT01556061|O2|Outcome|D-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
761418|NCT01556061|O2|Outcome|D-MAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
761419|NCT01556061|O1|Outcome|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
761420|NCT01556061|E2|Reported Event|DMAC Laryngoscopy First, Then C-MAC Video Laryngoscopy|D-MAC video laryngoscope (C-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with D-MAC video laryngoscope then a second laryngoscopy with the C-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with C-MAC laryngoscope.
761421|NCT01556061|E1|Reported Event|C-MAC Laryngoscopy First, Then DMAC Video Laryngoscopy|C-MAC video laryngoscope (D-MAC Intubation) : Patients assigned to this arm will have a first laryngoscopy with C-MAC video laryngoscope then a second laryngoscopy with the D-MAC video laryngoscope. Patients will be intubated after second laryngoscopy with D-MAC laryngoscope.
761422|NCT01555983|B1|Baseline|All Study Participants|All participants received all interventions
761777|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761424|NCT01555983|P5|Participant Flow|6.7%THC First, Then Placebo, Then 2.9%THC|6.7%THC in am of first intervention visit, then placebo in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
761425|NCT01555983|P4|Participant Flow|2.9%THC First, Then 6.7%THC, Then Placebo|2.9%THC in am of first intervention visit, then 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then placebo in am of third intervention visit (after 3-10 day washout period).
761426|NCT01555983|P3|Participant Flow|2.9%THC First, Then Placebo, Then 6.7%THC|2.9%THC in am of first intervention visit, placebo in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC am of third intervention visit (after 3-10 day washout period)
761427|NCT01555983|P2|Participant Flow|Placebo First, Then 6.7%THC, Then 2.9%THC|Placebo in am of first intervention visit, 6.7%THC in am of second intervention visit (after 3-10 day washout period) and then 2.9%THC in am of third intervention visit (after 3-10 day washout period).
761428|NCT01555983|P1|Participant Flow|Placebo First, Then 2.9%THC, Then 6.7% THC|Placebo in am of first intervention visit, 2.9%THC in am of second intervention visit (after 3-10 day washout period) and then 6.7%THC in am of third intervention visit (after 3-10 day washout period).
761429|NCT01555983|O3|Outcome|6.7% THC|Vaporization of Cannabis 6.7% THC
761430|NCT01555983|O2|Outcome|2.9% THC|Vaporization of Cannabis 2.9% THC
761431|NCT01555983|O1|Outcome|Placebo THC|Session at which placebo THC was administered
761432|NCT01555983|E3|Reported Event|6.7% THC|Vaporization of Cannabis 6.7% THC
761433|NCT01555983|E2|Reported Event|2.9% THC|Vaporization of Cannabis 2.9% THC
761434|NCT01555983|E1|Reported Event|Placebo THC|Vaporization of Cannabis Placebo THC
761435|NCT01555931|B3|Baseline|Total|Total of all reporting groups
761436|NCT01555931|B2|Baseline|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761437|NCT01555931|B1|Baseline|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761438|NCT01555931|P2|Participant Flow|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761439|NCT01555931|P1|Participant Flow|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761440|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761441|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761442|NCT01555931|O2|Outcome|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761443|NCT01555931|O1|Outcome|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761444|NCT01555931|E2|Reported Event|Control|"Placement 4-8 weeks after delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761445|NCT01555931|E1|Reported Event|Immediate|"Placement within 48 hours of delivery~Levonorgestrel-releasing intrauterine system: Placement within 48 hours of delivery"
761446|NCT01555164|B3|Baseline|Total|Total of all reporting groups
761447|NCT01555164|B2|Baseline|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
761448|NCT01555164|B1|Baseline|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
761463|NCT01555151|B1|Baseline|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
777567|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
761449|NCT01555164|P2|Participant Flow|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
761450|NCT01555164|P1|Participant Flow|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
761472|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761473|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761474|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761451|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
761452|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
761453|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
761454|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
761455|NCT01555164|O2|Outcome|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
761456|NCT01555164|O1|Outcome|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
761457|NCT01555164|E2|Reported Event|Ranolazine+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Ranolazine 500 mg (1 x 500 mg tablet) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus metformin 500 mg/metformin placebo (1 x 500 mg tablet active metformin plus 1 placebo tablet) twice daily from Day 8 through Week 24.~Participants were required to maintain their diet and exercise regimen."
761458|NCT01555164|E1|Reported Event|Placebo+Metformin|"Qualifying period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening) and participants who were ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: Metformin 1000 mg (2 x 500 mg tablets) twice daily plus placebo to match ranolazine twice daily through Week 24.~Participants were required to maintain their diet and exercise regimen."
761459|NCT01555151|B5|Baseline|Total|Total of all reporting groups
761460|NCT01555151|B4|Baseline|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761461|NCT01555151|B3|Baseline|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761462|NCT01555151|B2|Baseline|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
763006|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
761465|NCT01555151|P3|Participant Flow|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761466|NCT01555151|P2|Participant Flow|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761467|NCT01555151|P1|Participant Flow|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761468|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761469|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761470|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761471|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761778|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761476|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761477|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761478|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761479|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761480|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761481|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761482|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761483|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761484|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761485|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761486|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761487|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761488|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761489|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761490|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761491|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761492|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761493|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761494|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761495|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761496|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761497|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761498|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761499|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761500|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761501|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761502|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761503|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761504|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761505|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761506|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
763007|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
761507|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761508|NCT01555151|O4|Outcome|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761509|NCT01555151|O3|Outcome|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761510|NCT01555151|O2|Outcome|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761511|NCT01555151|O1|Outcome|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761512|NCT01555151|E5|Reported Event|Total|Total
761513|NCT01555151|E4|Reported Event|Mometasone Furoate 800 ug Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
761514|NCT01555151|E3|Reported Event|Mometasone Furoate 320 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
761515|NCT01555151|E2|Reported Event|Mometasone Furoate 200 ug Daily Via the Twisthaler® Device|Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
761516|NCT01555151|E1|Reported Event|Mometasone Furoate 80 ug Daily Via the Concept1 Device|Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
761517|NCT01555138|B3|Baseline|Total|Total of all reporting groups
761779|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761780|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761518|NCT01555138|B2|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761519|NCT01555138|B1|Baseline|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761520|NCT01555138|P2|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761521|NCT01555138|P1|Participant Flow|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761522|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761523|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761524|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761525|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761526|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761527|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761528|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761529|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761530|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761531|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761532|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761533|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761534|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761535|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761536|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761537|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761538|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761539|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761540|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761541|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761542|NCT01555138|O2|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol 50 mcg /fluticasone propionate 500 mcg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761543|NCT01555138|O1|Outcome|Indacaterol|Indacaterol 150 mcg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761544|NCT01555138|E2|Reported Event|Salmeterol/Fluticasone|Salmeterol 50 μg /fluticasone propionate 500 μg for inhalation delivered via a proprietary multi dose dry powder inhaler (MDDPI) device (Seretide® Accuhaler®) twice daily (b.i.d.)
761545|NCT01555138|E1|Reported Event|Indacaterol|Indacaterol 150 μg once daily (o.d.) delivered via the Novartis single dose dry power inhaler (SDDPI) (Onbrez® Breezhaler®)
761546|NCT01555073|B5|Baseline|Total|Total of all reporting groups
761547|NCT01555073|B4|Baseline|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
761548|NCT01555073|B3|Baseline|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
761549|NCT01555073|B2|Baseline|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
761550|NCT01555073|B1|Baseline|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
761551|NCT01555073|P4|Participant Flow|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
761552|NCT01555073|P3|Participant Flow|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
761553|NCT01555073|P2|Participant Flow|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
761554|NCT01555073|P1|Participant Flow|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
761555|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
761556|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
761557|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
761558|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
761559|NCT01555073|O4|Outcome|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
761560|NCT01555073|O3|Outcome|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
761561|NCT01555073|O2|Outcome|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
761562|NCT01555073|O1|Outcome|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
761563|NCT01555073|E4|Reported Event|Placebo Group|"Placebo group, two placebo tablets day of surgery and twice a day for 13 days~Placebo group: Placebo group, two placebo tablets day of surgery and twice a day for 13 days"
761564|NCT01555073|E3|Reported Event|Celecoxib/Placebo Group|"celecoxib/placebo twice a day for 13 days.~celecoxib/placebo: celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days."
761565|NCT01555073|E2|Reported Event|Pregabalin/Placebo Group|"pregabalin/placebo twice a day for 13 days.~pregabalin/placebo: pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days."
761566|NCT01555073|E1|Reported Event|Pregabalin/Celecoxib Group|"pregabalin/celecoxib twice a day for 13 days.~pregabalin/celecoxib: pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days."
761567|NCT01554982|B1|Baseline|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761568|NCT01554982|P1|Participant Flow|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761569|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761570|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761571|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761572|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761573|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761574|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761575|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761576|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761577|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761578|NCT01554982|O1|Outcome|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761579|NCT01554982|E1|Reported Event|Ferric Citrate|ferric citrate: Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
761638|NCT01554176|P2|Participant Flow|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761580|NCT01554904|B1|Baseline|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
761581|NCT01554904|P1|Participant Flow|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
761781|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761782|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761582|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
761583|NCT01554904|O1|Outcome|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
761584|NCT01554904|E1|Reported Event|Facial-Flex|Subjects meeting inclusion and exclusion criteria who do not have significant obstructive sleep apnea on home sleep study 1 undergo 6 weeks of training with the facial flex (FF) exerciser. At the end of the six weeks of training another sleep study (Home sleep study 2)was performed. The facial flex (FF) exerciser manufactured by Facial Concepts, Inc is an FDA approved Class I medical device for treatment of facial muscle laxity. Facial muscles tend to weaken with age. The combination of deteriorating elastic tissue and facial muscle weakness causes the face to sag. Facial flex consists of two plastic tipped curved lower bars which slide across each other. An external dynamic resistance is provided by elastic bands.
761585|NCT01554891|B4|Baseline|Total|Total of all reporting groups
761586|NCT01554891|B3|Baseline|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
761587|NCT01554891|B2|Baseline|Comparison of SAFE-TBI and VA Screen|100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen
761588|NCT01554891|B1|Baseline|Test-Retest Reliability of SAFE-TBI|100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen
761589|NCT01554891|P3|Participant Flow|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
761590|NCT01554891|P2|Participant Flow|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
761591|NCT01554891|P1|Participant Flow|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
761592|NCT01554891|O1|Outcome|Sensitivity and Specificity of SAFE-TBI|Sensitivity = True Positives/(True Positive + False Negatives) Specificity = True Negatives/(True Negative + False Positives)
761593|NCT01554891|O1|Outcome|Comparison of SAFE-TBI and VA Screen|Veterans
761594|NCT01554891|O1|Outcome|Test-Retest Reliability of SAFE-TBI|Cohort 1 was used to determine test-retest reliability of the SAFE-TBI instrument.
761595|NCT01554891|E3|Reported Event|Sensitivity and Specificity of SAFE-TBI|200 participants in WRNMMC and Fort Belvoir Community Hospital Brain Indices Study (100 with mild TBI; 100 without mild TBI).
761639|NCT01554176|P1|Participant Flow|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761640|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
761596|NCT01554891|E2|Reported Event|Comparison of SAFE-TBI and VA Screen|"100 OEF/OIF/OND veterans seeking care at Northern New England VA Research Consortium (NNEVARC) VA Medical Centers (VAMCs) who screen positive for TBI on VA Level 1 TBI screen This component of the project assessed the correlation of the VA TBI Level 1 screen with the SAFE-TBI.~Participants were OEF/OIF/OND veterans (seeking care at the Northern New England VA Research Consortium [NNEVARC]) that screen positive for TBI on the VA screen when seeking treatment at the VA. Prior to the second level in-depth TBI evaluation, they were interviewed by a TRC using SAFE-TBI."
761643|NCT01554176|O3|Outcome|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
761644|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761729|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761597|NCT01554891|E1|Reported Event|Test-Retest Reliability of SAFE-TBI|"100 OEF/OIF/OND veterans returning to Joint Base Lewis-McChord and Fort Bragg who screen positive for TBI on the Post Deployment Health Assessment (PDHA) TBI screen.~This component of the project assessed test-retest reliability (4-6 weeks), as well as the eﬀects of diﬀerent raters; Research Coordinators (TRCs) vs. experienced TBI Clinicians (TBICs) at the Madigan Army Medical Center (MAMC) TBI Clinic. Cohort 1 included subjects recently returned from deployment in Iraq or Afghanistan to Joint Base Lewis-McChord or veterans served at the White River Junction and Togus VAMC who screened positive for TBI on the PDHA. After the initial interview, the SAFE-TBI will be administered for the second time 4-6 weeks later. Participants were assigned to one of four assessment paradigms (i. TRC time 1 and TBIC time 2; ii. TRC time 1 and TRC time 2; iii. TBIC time 1 and TBIC time 2; or iv. TBIC time 1 and TRC time 2)."
761598|NCT01554579|B3|Baseline|Total|Total of all reporting groups
761599|NCT01554579|B2|Baseline|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
761600|NCT01554579|B1|Baseline|Sugar Pill|Sugar Pill: Placebo
761601|NCT01554579|P2|Participant Flow|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
761602|NCT01554579|P1|Participant Flow|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
761603|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
761604|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo
761605|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
761606|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo
761607|NCT01554579|O2|Outcome|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
761608|NCT01554579|O1|Outcome|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
761609|NCT01554579|E2|Reported Event|Gefapixant|Gefapixant: BID Subjects received one tablet twice daily for 4 weeks.
761610|NCT01554579|E1|Reported Event|Sugar Pill|Sugar Pill: Placebo Subjects in the trial received one tablet twice daily for 4 weeks.
761611|NCT01554241|B5|Baseline|Total|Total of all reporting groups
761612|NCT01554241|B4|Baseline|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
761613|NCT01554241|B3|Baseline|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
761614|NCT01554241|B2|Baseline|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
761615|NCT01554241|B1|Baseline|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
761616|NCT01554241|P4|Participant Flow|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
761617|NCT01554241|P3|Participant Flow|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
761618|NCT01554241|P2|Participant Flow|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
761619|NCT01554241|P1|Participant Flow|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
761620|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
761621|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
761622|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
761623|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
761624|NCT01554241|O4|Outcome|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
761625|NCT01554241|O3|Outcome|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
761626|NCT01554241|O2|Outcome|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
761627|NCT01554241|O1|Outcome|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
761628|NCT01554241|E4|Reported Event|50,000 IU/Week D3|"D3 50,000 IU weekly~D3 50,000 IU weekly: vitamin D3 50,000 IU/week"
761629|NCT01554241|E3|Reported Event|Vitamin D3 4000 IU/Day|"D3 4000 IU/day~D3 4000 IU/day: vitamin D3 4000 IU/day"
761630|NCT01554241|E2|Reported Event|2000 IU/Day D3|"D3 2000 IU/day~D3 2000 IU/day: 2000 IU/day D3"
761631|NCT01554241|E1|Reported Event|Vitamin D3 800 IU/Day|"recommended daily dosage of 800 IU/day D3~vitamin D3 800 IU/day: vitamin D3 800 IU/day"
761632|NCT01554176|B3|Baseline|Total|Total of all reporting groups
761633|NCT01554176|B2|Baseline|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761634|NCT01554176|B1|Baseline|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761635|NCT01554176|P5|Participant Flow|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week Treatment Phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the Treatment Phase.
761636|NCT01554176|P4|Participant Flow|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761637|NCT01554176|P3|Participant Flow|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761681|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761641|NCT01554176|O2|Outcome|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761642|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761645|NCT01554176|O1|Outcome|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761646|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761647|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761648|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761649|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761650|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761651|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761652|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761653|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761654|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761655|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761656|NCT01554176|O2|Outcome|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761657|NCT01554176|O1|Outcome|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761658|NCT01554176|E5|Reported Event|Placebo/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received placebo once daily during the treatment phase.
761659|NCT01554176|E4|Reported Event|Filorexant 10 mg/Placebo (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered placebo once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761660|NCT01554176|E3|Reported Event|Filorexant 10 mg/Filorexant 10 mg (Run-out Phase)|Run-out Phase: Following completion of the 6-week treatment phase, participants in this group were administered filorexant 10 mg once daily at bedtime for 2 weeks. Participants in this group had received filorexant 10 mg once daily during the treatment phase.
761661|NCT01554176|E2|Reported Event|Placebo (Treatment Phase)|Treatment Phase: Participants in this group were administered placebo once daily at bedtime for 6 weeks.
761662|NCT01554176|E1|Reported Event|Filorexant 10 mg (Treatment Phase)|Treatment Phase: Participants in this group were administered filorexant 10 mg once daily at bedtime for 6 weeks.
761663|NCT01554163|B3|Baseline|Total|Total of all reporting groups
761664|NCT01554163|B2|Baseline|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761665|NCT01554163|B1|Baseline|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761666|NCT01554163|P2|Participant Flow|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761667|NCT01554163|P1|Participant Flow|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761668|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761669|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761670|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761671|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761672|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761673|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761674|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761675|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761676|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761677|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761678|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761679|NCT01554163|O1|Outcome|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761680|NCT01554163|O2|Outcome|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761682|NCT01554163|E2|Reported Event|Celecoxib 200 mg|Celecoxib 200 mg administered orally once daily for 12 weeks.
761683|NCT01554163|E1|Reported Event|Etoricoxib 30 mg|Etoricoxib 30 mg administered orally once daily for 12 weeks.
761684|NCT01553851|B1|Baseline|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761685|NCT01553851|P1|Participant Flow|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761728|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761991|NCT01552343|O1|Outcome|All Participants|All study participants
761686|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761687|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761688|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761689|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761690|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761691|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761692|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761693|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761694|NCT01553851|O1|Outcome|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761695|NCT01553851|E1|Reported Event|GSK1120212|"GSK1120212 2 mg PO daily for a total of 14 days with the intent of the last pill being the day before surgery.~GSK1120212: Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins."
761696|NCT01553708|B3|Baseline|Total|Total of all reporting groups
761697|NCT01553708|B2|Baseline|Silver Zinc Sulfadiazine Cream|
761698|NCT01553708|B1|Baseline|Epidermal Growth Factor With Silver Sulfadiazine Cream|
761699|NCT01553708|P2|Participant Flow|Silver Zinc Sulfadiazine Cream|
761700|NCT01553708|P1|Participant Flow|Epidermal Growth Factor With Silver Sulfadiazine Cream|
761701|NCT01553708|O2|Outcome|Silver Zinc Sulfadiazine Cream|Wounds treated with the cream containing silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
761702|NCT01553708|O1|Outcome|Epidermal Growth Factor With Silver Sulfadiazine Cream|Wounds treated with the cream containing epidermal growth factor and silver sulfadiazine evenly and covered with sterile gauze. Wounds were also cleaned with sterile normal saline daily and the cream was applied again after cleaning.
761703|NCT01553708|E2|Reported Event|Silver Zinc Sulfadiazine Cream|
761704|NCT01553708|E1|Reported Event|Epidermal Growth Factor With Silver Sulfadiazine Cream|
761705|NCT01553539|B1|Baseline|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
761706|NCT01553539|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) subcutaneous (SC) once daily in the absence of disease progression or unacceptable toxicity.
761707|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
761708|NCT01553539|O1|Outcome|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
761709|NCT01553539|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|Patients receive therapeutic angiotensin-(1-7) SC once daily in the absence of disease progression or unacceptable toxicity.
761710|NCT01553318|B3|Baseline|Total|Total of all reporting groups
761711|NCT01553318|B2|Baseline|Placebo|Participants who received the placebo
761712|NCT01553318|B1|Baseline|Ketotifen Group|Participants who received the active drug - ketotifen
761713|NCT01553318|P2|Participant Flow|Placebo|Placebo medication
761714|NCT01553318|P1|Participant Flow|Ketotifen|ketotifen active group
761715|NCT01553318|O2|Outcome|Placebo|placebo group
761725|NCT01553292|B1|Baseline|Angiocath Surfactant|Preterm infants born at 24 to 34 weeks of postmenstrual gestational age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761726|NCT01553292|P1|Participant Flow|Surfactant Through Vascular Catheter|Preterm infants born between 24 to 34 weeks postmenstrual gestation were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)during 1st 24 hours of life
761727|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761771|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761772|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761730|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761731|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761732|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761733|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761734|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761735|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants between 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761736|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761737|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761738|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants born between 24 to 34 weeks post-menstrual age were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761739|NCT01553292|O1|Outcome|Surfactant Administration Through Vascular Catheter|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761740|NCT01553292|E1|Reported Event|Angiocath Surfactant|Preterm infants from 24 to 34 weeks were received surfactant by using technique called ECALMIST (Early CPAP And Large Volume Minimal Invasive Surfactant)
761741|NCT01553240|B1|Baseline|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
761742|NCT01553240|P1|Participant Flow|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
761743|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
761744|NCT01553240|O1|Outcome|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
761745|NCT01553240|E1|Reported Event|TMS and fMRI|"functional MRI~single and paired pulse TMS (to identify the difference of motor excitability between patients and healthy controls)~TMS and functional MRI (Magstim): single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging."
761746|NCT01552954|B3|Baseline|Total|Total of all reporting groups
761747|NCT01552954|B2|Baseline|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
761748|NCT01552954|B1|Baseline|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
761825|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
761749|NCT01552954|P2|Participant Flow|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
761750|NCT01552954|P1|Participant Flow|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
761773|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761774|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761775|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761776|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761751|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
761752|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
761753|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
761754|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
761755|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
761756|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
761757|NCT01552954|O2|Outcome|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
761758|NCT01552954|O1|Outcome|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
761759|NCT01552954|E2|Reported Event|Intensive Education of Low-salt Diet Group|"For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.~Intensive education for low salt diet : For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks."
761760|NCT01552954|E1|Reported Event|Conventional Education of Low-salt Diet Group|Education for low salt diet will be conducted as in office with brief communication with a patient and a physician.
761761|NCT01552928|B5|Baseline|Total|Total of all reporting groups
761762|NCT01552928|B4|Baseline|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
761763|NCT01552928|B3|Baseline|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
761764|NCT01552928|B2|Baseline|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
761765|NCT01552928|B1|Baseline|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
761766|NCT01552928|P4|Participant Flow|Placebo, Then Anag 0.5 mg, Then Mox 400 mg, Then Anag 2.5 mg|A single oral dose of placebo on Day 1 for Period 1; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 3; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 4.
761767|NCT01552928|P3|Participant Flow|Mox 400 mg, Then Placebo, Then Anag 2.5 mg, Then Anag 0.5 mg|A single oral dose of 400 mg of moxifloxacin on Day 1 for Period 1; then a single oral dose of placebo on Day 1 for Period 2; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 4.
761826|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
761768|NCT01552928|P2|Participant Flow|Anag 2.5 mg, Then Mox 400 mg, Then Anag 0.5 mg, Then Placebo|A single oral dose of 2.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 2; then a single oral dose of 0.5 mg of anagrelide on Day 1 for Period 3; then a single oral dose of placebo on Day 1 for Period 4.
761769|NCT01552928|P1|Participant Flow|Anag 0.5 mg, Then Anag 2.5 mg, Then Placebo, Then Mox 400 mg|A single oral dose of 0.5 mg of anagrelide on Day 1 for Period 1; then a single oral dose of 2.5 mg of anagrelide on Day 1 for Period 2; then a single oral dose of placebo on Day 1 for Period 3; then a single oral dose of 400 mg of moxifloxacin on Day 1 for Period 4.
761770|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761783|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761784|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761785|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 2.5 mg of anagrelide
761786|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 2.5 mg of anagrelide
761787|NCT01552928|O2|Outcome|BCH24426 (Females)|Metabolite from a single oral dose of 0.5 mg of anagrelide
761788|NCT01552928|O1|Outcome|BCH24426 (Males)|Metabolite from a single oral dose of 0.5 mg of anagrelide
761789|NCT01552928|O2|Outcome|Anagrelide 2.5mg (Females)|A single oral dose of 2.5 mg of anagrelide
761790|NCT01552928|O1|Outcome|Anagrelide 2.5mg (Males)|A single oral dose of 2.5 mg of anagrelide
761791|NCT01552928|O2|Outcome|Anagrelide 0.5 mg (Females)|A single oral dose of 0.5 mg of anagrelide
761792|NCT01552928|O1|Outcome|Anagrelide 0.5 mg (Males)|A single oral dose of 0.5 mg of anagrelide
761793|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761794|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761795|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761796|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761797|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761798|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761799|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761800|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761801|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761802|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761803|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761804|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761805|NCT01552928|O3|Outcome|Moxifloxacin 400 mg|A single oral dose of 400 mg of moxifloxacin
761806|NCT01552928|O2|Outcome|Anagrelide 2.5 mg|A single oral dose of 2.5 mg of anagrelide
761807|NCT01552928|O1|Outcome|Anagrelide 0.5 mg|A single oral dose of 0.5 mg of anagrelide
761808|NCT01552928|E4|Reported Event|Placebo|
761809|NCT01552928|E3|Reported Event|Moxifloxacin 400mg|
761810|NCT01552928|E2|Reported Event|Anagrelide 2.5mg|
761811|NCT01552928|E1|Reported Event|Anagrelide 0.5mg|
761812|NCT01552915|B4|Baseline|Total|Total of all reporting groups
761813|NCT01552915|B3|Baseline|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
761814|NCT01552915|B2|Baseline|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
761815|NCT01552915|B1|Baseline|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761816|NCT01552915|P3|Participant Flow|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
761817|NCT01552915|P2|Participant Flow|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day
761818|NCT01552915|P1|Participant Flow|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761819|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
761820|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
761821|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761822|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
761823|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
761824|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761886|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
761827|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761828|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
761829|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
761830|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761831|NCT01552915|O3|Outcome|OROS-MPH|Subjects received over encapsulated OROS-MPH titrated to an optimal dose of 18, 36, 54, or 72mg/day. Subjects optimized to 72mg received two 36mg tablets.
761832|NCT01552915|O2|Outcome|SPD489|Subjects received over encapsulated SPD489 titrated to an optimal dose of 30, 50, or 70mg/day.
761833|NCT01552915|O1|Outcome|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761834|NCT01552915|E3|Reported Event|OROS-MPH|Subjects received over encapsulated OROS-MPH optimized among a 18, 36, 54 or 72mg dose. Subjects optimized to 72mg received two 36mg tablets.
761835|NCT01552915|E2|Reported Event|SPD489|Subjects received over encapsulated SPD489 optimized among a 30, 50, or 70mg dose.
761836|NCT01552915|E1|Reported Event|Placebo|Subjects received over encapsulated placebo that matched the SPD489 and OROS-MPH capsules.
761837|NCT01552902|B4|Baseline|Total|Total of all reporting groups
761838|NCT01552902|B3|Baseline|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761839|NCT01552902|B2|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761840|NCT01552902|B1|Baseline|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761841|NCT01552902|P3|Participant Flow|Methylphenidate|Methylphenidate (Concerta, Osmotic controlled oral release delivery system-methylphenidate [OROS-MPH]) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761842|NCT01552902|P2|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 milligram (mg) over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761843|NCT01552902|P1|Participant Flow|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761844|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761845|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761846|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761847|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761848|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761849|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761850|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761851|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761852|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761853|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761854|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761855|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761856|NCT01552902|O3|Outcome|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761857|NCT01552902|O2|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761858|NCT01552902|O1|Outcome|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761859|NCT01552902|E3|Reported Event|Methylphenidate|Methylphenidate (Concerta, OROS-MPH) 18 to 72 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule (no placebo administered when methylphenidate 72 mg [2*36 mg capsules] was administered) for 4 weeks (forced dose titration), followed by methylphenidate 72 mg (2*36 mg capsules) over encapsulated capsule once daily orally for 2 weeks (dose maintenance).
761860|NCT01552902|E2|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (LDX, Vyvanse®, SPD489) 30 to 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 4 weeks (forced dose titration), followed by LDX 70 mg over encapsulated capsule once daily orally along with placebo over encapsulated capsule for 2 weeks (dose maintenance).
761861|NCT01552902|E1|Reported Event|Placebo|2 placebo over encapsulated capsules once daily orally for 6 weeks.
761862|NCT01552889|B3|Baseline|Total|Total of all reporting groups
761992|NCT01552343|O1|Outcome|All Participants|All study participants
761863|NCT01552889|B2|Baseline|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
761864|NCT01552889|B1|Baseline|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
761865|NCT01552889|P2|Participant Flow|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
761866|NCT01552889|P1|Participant Flow|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
761867|NCT01552889|O2|Outcome|Collaborative Care|Same as above
761868|NCT01552889|O1|Outcome|Usual Care|Same as above
761869|NCT01552889|O2|Outcome|Collaborative Care|Same as above
761870|NCT01552889|O1|Outcome|Usual Care|Same as above
761871|NCT01552889|O2|Outcome|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
761872|NCT01552889|O1|Outcome|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
761873|NCT01552889|E2|Reported Event|Collaborative Care (CC)|"Patients randomized to the Collaborate Care (CC) arm of this study will receive brief screening, consultative, and referral services. This collaborative approach includes the patient, the patient's PCP, the cardiologist, and the nurse case manager (NCM), using evidence based recommendations for depression treatment and follow-up care.~Collaborative Care: No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period."
761874|NCT01552889|E1|Reported Event|Usual Care (UC)|Patients will receive only the care provided by their primary care physicians or other medical professionals outside of the study.
761875|NCT01552876|B1|Baseline|All Subjects|All subjects who were enrolled at baseline.
761876|NCT01552876|P2|Participant Flow|Nelfilcon A/ Etafilcon A/ Filcon II 3|nelfilcon A worn first, etafilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
761877|NCT01552876|P1|Participant Flow|Etafilcon A/ Nelfilcon A/Filcon II 3|etafilcon A worn first, nelfilcon A worn second, Filcon II 3 worn third. Only etafilcon A and nelfilcon A were used in phase I of the study per study protocol, with Filcon II 3 being added to the rotation in Phase II (see outcome 5).
761878|NCT01552876|O3|Outcome|Filcon II 3|All subjects wore the Filcon II 3 lens after the wearing of the etafilcon and nelfilcon lenses.
761879|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore Nelfilcon A
761880|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
761881|NCT01552876|O2|Outcome|Nelfilcon A|Those subjects who wore nelfilcon A.
761882|NCT01552876|O1|Outcome|Etafilcon A|Those subjects who wore etafilcon A.
761883|NCT01552876|O2|Outcome|Nelfilcon A.|Those who wore nelfilcon A.
761884|NCT01552876|O1|Outcome|Etafilcon A|Those who wore etafilcon A.
761885|NCT01552876|O2|Outcome|Nelfilcon A|Those who wore nelfilcon A.
761892|NCT01552772|B1|Baseline|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761893|NCT01552772|P1|Participant Flow|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761894|NCT01552772|O1|Outcome|Total|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761895|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761993|NCT01552343|O2|Outcome|Responders|Participants who experienced a reduction from baseline of >=33% in nocturnal voids at the Month 1
761896|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761897|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761898|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761899|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761900|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761901|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761902|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761903|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761904|NCT01552772|O1|Outcome|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761905|NCT01552772|E1|Reported Event|Aripiprazole IM Depot 400mg|Participants were stabilized on one of the following atypical oral antipsychotic medication for at least 14 days before Day 1: risperidone, quetiapine, olanzapine, ziprasidone, or paliperidone. On Day 1, participants were administered a single aripiprazole IM depot 400 mg injection. Concomitant to the aripiprazole IM depot injection, participants continued to receive their current atypical antipsychotic medication for 14 days.
761906|NCT01552694|B3|Baseline|Total|Total of all reporting groups
761907|NCT01552694|B2|Baseline|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
761908|NCT01552694|B1|Baseline|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
761909|NCT01552694|P2|Participant Flow|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
761910|NCT01552694|P1|Participant Flow|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
777568|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
761911|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
761912|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
761913|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
761914|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
761915|NCT01552694|O2|Outcome|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
761916|NCT01552694|O1|Outcome|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
761917|NCT01552694|E2|Reported Event|Placebo|"Matching placebo daily for 2 months~Placebo: oral, matching placebo daily for 2 months"
761918|NCT01552694|E1|Reported Event|Sitagliptin|"100 mg sitagliptin/day for 2 months~Sitagliptin: Oral, 100 mg/day for 2 months"
761919|NCT01552681|B3|Baseline|Total|Total of all reporting groups
761920|NCT01552681|B2|Baseline|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761921|NCT01552681|B1|Baseline|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761922|NCT01552681|P2|Participant Flow|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761923|NCT01552681|P1|Participant Flow|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761924|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761925|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761926|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761927|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761928|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761929|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761930|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761931|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761932|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761933|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761934|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761935|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761936|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761937|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761938|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761939|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761940|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761941|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761942|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761943|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761944|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761945|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761946|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761947|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761948|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761949|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761950|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761951|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761952|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761953|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761954|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761955|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761956|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
763008|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
761957|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761958|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761959|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761960|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761961|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761962|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761963|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761964|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761965|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761966|NCT01552681|O2|Outcome|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761967|NCT01552681|O1|Outcome|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
763048|NCT01545700|O3|Outcome|Placebo 0-4 Hours-2 Hours|Placebo 0-4 hours-2 hours
761968|NCT01552681|E2|Reported Event|Placebo|Participants were randomized to receive one subcutaneous injection of placebo every week for 24 weeks.
761969|NCT01552681|E1|Reported Event|Baminercept 100 mg|Participants were randomized to receive one subcutaneous injection of 100 mg baminercept every week for 24 weeks.
761970|NCT01552603|B1|Baseline|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
761971|NCT01552603|P1|Participant Flow|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
761972|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
761973|NCT01552603|O1|Outcome|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
761974|NCT01552603|E1|Reported Event|Artificial Pancreas Control|"Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 28 hours. For the entire study, the adaptive component of Artificial Pancreas Control Software will be used to control the subject's blood glucose.~Artificial Pancreas Control Software: This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm."
761975|NCT01552343|B3|Baseline|Total|Total of all reporting groups
761976|NCT01552343|B2|Baseline|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761977|NCT01552343|B1|Baseline|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761978|NCT01552343|P2|Participant Flow|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761979|NCT01552343|P1|Participant Flow|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761980|NCT01552343|O4|Outcome|Male - Desmopressin 75 μg|Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
762011|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
761981|NCT01552343|O3|Outcome|Female - Desmopressin 25 μg|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761982|NCT01552343|O2|Outcome|Male - Placebo|Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761983|NCT01552343|O1|Outcome|Female - Placebo|Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761984|NCT01552343|O4|Outcome|Male - Desmopressin 75 μg|Male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761985|NCT01552343|O3|Outcome|Female - Desmopressin 25 μg|Female participants took 1 tablet of 25 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761986|NCT01552343|O2|Outcome|Male - Placebo|Male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761987|NCT01552343|O1|Outcome|Female - Placebo|Female participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761988|NCT01552343|O1|Outcome|All Participants|All study participants
761989|NCT01552343|O2|Outcome|>= 3 Voids|Study participants who had >=3 voids average from the screening and baseline diaries.
761990|NCT01552343|O1|Outcome|< 3 Voids|Study participants who had <3 voids average from the screening and baseline diaries.
761994|NCT01552343|O1|Outcome|Non-Responders|Participants who experienced a reduction from baseline of <33% in nocturnal voids at the Month 1
761995|NCT01552343|O1|Outcome|All Participants|All study participants
761996|NCT01552343|E2|Reported Event|Desmopressin|Female participants took 1 desmopressin 25 μg tablet and male participants took 1 tablet 75 μg every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761997|NCT01552343|E1|Reported Event|Placebo|Female and male participants took 1 tablet of placebo every night, approximately 1 hour prior to bedtime (with the intention to sleep), for a period of 1 month.
761998|NCT01552057|B3|Baseline|Total|Total of all reporting groups
761999|NCT01552057|B2|Baseline|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
762000|NCT01552057|B1|Baseline|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
762001|NCT01552057|P2|Participant Flow|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
762002|NCT01552057|P1|Participant Flow|Duloxetine 60 mg|"Treatment Period: Up to 60-milligram (mg) dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
762003|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762004|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762005|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762006|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762007|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762008|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762009|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762010|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762012|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762013|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762014|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762015|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762016|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762017|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762018|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762019|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762020|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762021|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762022|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762023|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762024|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762025|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762026|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762027|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762028|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762029|NCT01552057|O2|Outcome|Placebo|Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.
762030|NCT01552057|O1|Outcome|Duloxetine 60 mg|Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).
762031|NCT01552057|E2|Reported Event|Placebo|"Treatment Period: 3 placebo capsules administered orally once daily for 14 weeks.~During the 1-week taper, the number of placebo capsules was gradually reduced. For the first 3 days: 2 placebo capsules administered orally once daily. For the remaining 4 days: 1 placebo capsule administered orally once daily."
762032|NCT01552057|E1|Reported Event|Duloxetine 60 mg|"Treatment Period: Up to 60-mg dose of duloxetine administered orally once daily for 14 weeks. During the first 2 weeks of treatment, participants gradually increased their dosage. Week 1: 20-mg dose of duloxetine (one 20-mg capsule, and 2 placebo capsules), Week 2: 40-mg dose of duloxetine (two 20-mg capsules and 1 placebo capsule), Weeks 3 to 14: 60-mg dose of duloxetine (three 20-mg capsules).~During the 1-week taper, the daily dosage was gradually reduced. For the first 3 days: 40-mg dose of duloxetine (two 20-mg capsules) administered orally once daily. For the remaining 4 days: 20-mg dose of duloxetine (one 20-mg capsule) administered orally once daily."
762033|NCT01551979|B3|Baseline|Total|Total of all reporting groups
762034|NCT01551979|B2|Baseline|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762080|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762035|NCT01551979|B1|Baseline|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762036|NCT01551979|P2|Participant Flow|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762037|NCT01551979|P1|Participant Flow|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762038|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762039|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762295|NCT01549977|B2|Baseline|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762040|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762041|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762042|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762043|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762044|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762045|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762046|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762047|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762048|NCT01551979|O2|Outcome|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762049|NCT01551979|O1|Outcome|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762050|NCT01551979|E2|Reported Event|Sham rTMS|"Sham rTMS to the vermis (lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762051|NCT01551979|E1|Reported Event|Active rTMS|"High frequency rTMS stimulation of the vermis(lobule VII) of the cerebellum.~Repetitive Transcranial Magnetic Stimulation: intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.~Sham participants will undergo the same procedures as those in the active rTMS group."
762052|NCT01551888|B1|Baseline|Overall Study Population|All patients participating in the crossover study
777569|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
762053|NCT01551888|P2|Participant Flow|Sequence 2|Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
762054|NCT01551888|P1|Participant Flow|Sequence 1|Aclidinium/formoterol 400 μg/12 μg FDC (via the Almirall inhaler) one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day in Period 1 and, in Period 2, Formoterol 12 μg via the Foradil® Aerolizer®, one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) for 1 day
762055|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
762056|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
762057|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
762058|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
762059|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
762060|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
762061|NCT01551888|O2|Outcome|Aclidinium/Formoterol 400/12 μg FDC|Fixed dose combination (FDC) administered via Almirall inhaler
762062|NCT01551888|O1|Outcome|Formoterol 12 μg|Administered via Foradil® Aerolizer®
762063|NCT01551888|E2|Reported Event|Formoterol 12 μg|Administered via Foradil® Aerolizer®
762064|NCT01551888|E1|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed dose combination (FDC) administered via Almirall inhaler
762065|NCT01551758|B3|Baseline|Total|Total of all reporting groups
762066|NCT01551758|B2|Baseline|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762067|NCT01551758|B1|Baseline|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762068|NCT01551758|P2|Participant Flow|Fluticasone Furoate (FF)/Vilanterol (VI) 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762069|NCT01551758|P1|Participant Flow|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762070|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762071|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762072|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762073|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762074|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762075|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762076|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762077|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762078|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762079|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
763009|NCT01545765|O4|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - Second Application Time|
762081|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762082|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762083|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762084|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762085|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762169|NCT01551173|E2|Reported Event|LescolIR (Fluvastatin Sodium Immediate Release Capsule)|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
762086|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762087|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762088|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762089|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762090|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762091|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762092|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762093|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762094|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|ExParticipants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762095|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762096|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762097|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762098|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762099|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762100|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone furoate /vilanterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762101|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762102|NCT01551758|O2|Outcome|FF/VI 100 mcg/25 mcg|"Existing Maintenance Therapy:~Long acting bronchodilator therapy alone~ICS alone or in combination with a long acting bronchodilator~Triple maintenance therapy"
762103|NCT01551758|O1|Outcome|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762104|NCT01551758|E2|Reported Event|FF/VI 100 mcg/25 mcg|Participants were prescribed one inhalation of fluticasone fuorate /vilaneterol (FF/VI) 100 mcg/25 mcg via dry powder inhaler (DPI) once daily in the morning for 12 months in lieu of existing maintenance therapy. Participants on previous triple therapy received LAMA therapy additionally.
762105|NCT01551758|E1|Reported Event|Usual Care|Participants continued their existing maintenance therapy that included one of the following: an inhaled corticosteroid (ICS) alone or Long Acting Beta Agonist (LABA) alone or Long Acting Muscarinic Antagonist (LAMA) alone or combination of any two (ICS+LABA/ ICS+LAMA/ LABA+LAMA) or triple therapy (ICS+LABA+LAMA) at the appropriate dosing schedule, for 12 months
762106|NCT01551693|B3|Baseline|Total|Total of all reporting groups
814297|NCT01346475|B1|Baseline|Valacyclovir|
762107|NCT01551693|B2|Baseline|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762108|NCT01551693|B1|Baseline|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762109|NCT01551693|P2|Participant Flow|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762110|NCT01551693|P1|Participant Flow|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762111|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762112|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762113|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762114|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762115|NCT01551693|O2|Outcome|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762116|NCT01551693|O1|Outcome|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762117|NCT01551693|E2|Reported Event|STA-9090 Cohort B|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort B patients received STA-9090 150 mg/m2 twice weekly (d1, 4, 8, 11, 15, 18 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762118|NCT01551693|E1|Reported Event|STA-9090 Cohort A|Patients enrolled into two possible cohorts based on tumor expression of BRAF: Cohort A – BRAF mutant disease or Cohort B – BRAF wild type. Cohort A patients received STA-9090 200 mg/m2 once weekly (d1, 8, 15 of 28 day cycle). Patients were treated until evidence of disease progression, unacceptable toxicity, intercurrent illness or withdrawal.
762119|NCT01551355|B7|Baseline|Total|Total of all reporting groups
762120|NCT01551355|B6|Baseline|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
762121|NCT01551355|B5|Baseline|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher’s guide.
762122|NCT01551355|B4|Baseline|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
777570|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
762123|NCT01551355|B3|Baseline|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
762124|NCT01551355|B2|Baseline|Usual Curriculum - Children|Control preschool facilities continued with their usual preschool curriculum
762125|NCT01551355|B1|Baseline|Healthy Habits Intervention - Children|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
762126|NCT01551355|P6|Participant Flow|Usual Curriculum - Teachers|Control preschool facilities continued with their usual preschool curriculum
762127|NCT01551355|P5|Participant Flow|Healthy Habits Intervention - Teachers|Teachers participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received teacher's guide.
762128|NCT01551355|P4|Participant Flow|Usual Curriculum - Parents/Caregivers|Control preschool facilities continued with their usual preschool curriculum
762129|NCT01551355|P3|Participant Flow|Healthy Habits Intervention - Parents/Caregivers|Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children.
762130|NCT01551355|P2|Participant Flow|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
763049|NCT01545700|O2|Outcome|Placebo 0-4 Hours-1 Hour|Placebo 0-4 hours-1 hour
762131|NCT01551355|P1|Participant Flow|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
762132|NCT01551355|O2|Outcome|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
762133|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
762134|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
762135|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
762136|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
762137|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
762138|NCT01551355|O2|Outcome|Usual Curriculum|education imparted by teachers control preschool facilities continued with their usual preschool curriculum
762139|NCT01551355|O1|Outcome|Healthy Habits Intervention|"Preschool Facility* Intervention Arm classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
762140|NCT01551355|E2|Reported Event|Usual Curriculum|children - education imparted by teachers control preschool facilities continued with their usual preschool curriculum
762141|NCT01551355|E1|Reported Event|Healthy Habits Intervention|"Preschool Facility* Intervention Arm children provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes."
762142|NCT01551303|B3|Baseline|Total|Total of all reporting groups
762143|NCT01551303|B2|Baseline|Placebo|Placebo, 0.77 ml, intranasal
762144|NCT01551303|B1|Baseline|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
762145|NCT01551303|P2|Participant Flow|Placebo|Placebo, 0.77 ml, intranasal
762146|NCT01551303|P1|Participant Flow|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
762147|NCT01551303|O2|Outcome|Placebo|Placebo, 0.77 ml, intranasal
762148|NCT01551303|O1|Outcome|Oxytocin|Oxytocin, 30 IU in 0.77 ml, intranasal
762149|NCT01551303|E2|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
762150|NCT01551303|E1|Reported Event|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
762151|NCT01551199|B1|Baseline|Multiple Channel Exposure Therapy (MCET)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
762152|NCT01551199|P1|Participant Flow|Multiple Channel Exosure Therapy (MCET-V)|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
762153|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
762154|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
762155|NCT01551199|O1|Outcome|MCET-V|MCET-V is a 12-session intervention targeting panic and PTSD symptoms.
762156|NCT01551199|E1|Reported Event|Arm 1|"MCET-V is a cognitive-behavioral treatment for persons with comorbid PTSD and panic attacks~Multiple Channel Exposure Therapy- Veterans: Individual therapy design completed twice a week over a 6-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises."
762157|NCT01551173|B3|Baseline|Total|Total of all reporting groups
762274|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762158|NCT01551173|B2|Baseline|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
762159|NCT01551173|B1|Baseline|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
762160|NCT01551173|P2|Participant Flow|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
762161|NCT01551173|P1|Participant Flow|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
762162|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
762163|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
762164|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
762165|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
762166|NCT01551173|O2|Outcome|Fluvastatin Sodium Immediate Release Capsule|Oral Fluvastatin sodium Immediate Release Capsule 40mg twice daily for 12 weeks
762167|NCT01551173|O1|Outcome|Fluvastatin Sodium Extended Release Tablet|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
762168|NCT01551173|E3|Reported Event|Total|
762170|NCT01551173|E1|Reported Event|LescolXL (Fluvastatin Sodium Extended Release Tablet)|Oral Fluvastatin sodium Extended Release Tablet 80mg once daily for 12 weeks
762171|NCT01551095|B1|Baseline|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
762172|NCT01551095|P1|Participant Flow|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
762173|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
762174|NCT01551095|O1|Outcome|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
762175|NCT01551095|E1|Reported Event|PEGJ|"Patients in this arm will receive self-propelled balloon PEGJ tube.~PEGJ tube: The self-propelled PEGJ feeding tube"
762176|NCT01551082|B1|Baseline|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
762177|NCT01551082|P1|Participant Flow|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
762178|NCT01551082|O1|Outcome|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
762179|NCT01551082|E1|Reported Event|Outpatient Chest Tubes|All patients, mixed gender, race, and age, who underwent thoracic resection by one surgeon over the past seven years and discharged home with air leak present and chest tube to portable drainage device.
762180|NCT01550965|B1|Baseline|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762181|NCT01550965|P1|Participant Flow|Participants Receiving Adalimumab|Adults with active ulcerative colitis (UC) who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762182|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762183|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762184|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762185|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|"Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.~Adalimumab: Adalimumab pre-filled syringe, administered by subcutaneous injection"
762186|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762187|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
777571|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
762188|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762189|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762190|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762191|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762215|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
762296|NCT01549977|B1|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762192|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762193|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762194|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762195|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762196|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762197|NCT01550965|O1|Outcome|Participants Receiving Adalimumab|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762198|NCT01550965|E1|Reported Event|PARTICIPANTS RECEIVING ADALIMUMAB|Adults with active UC who had failed conventional therapy received Adalimumab 160 mg at Baseline Visit, 80 mg at Week 2 Visit, and 40 mg every other week (EOW) starting at Week 4. Non-responders to adalimumab were to be discontinued from treatment at Week 8. After Week 8, dose escalation to 40 mg weekly was allowed for flare or non-response.
762199|NCT01550952|B1|Baseline|Total Shoulder Arthroplasty Patients|
762200|NCT01550952|P1|Participant Flow|Total Shoulder Arthroplasty Patients|
762201|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
762202|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
762203|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
762204|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
762205|NCT01550952|O1|Outcome|Total Shoulder Arthroplasty Patients|
762206|NCT01550952|E1|Reported Event|Total Shoulder Arthroplasty Patients|
762207|NCT01550809|B3|Baseline|Total|Total of all reporting groups
762208|NCT01550809|B2|Baseline|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
762209|NCT01550809|B1|Baseline|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
762210|NCT01550809|P2|Participant Flow|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
762211|NCT01550809|P1|Participant Flow|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
762275|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762276|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762277|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762212|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
762213|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
762214|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
763050|NCT01545700|O1|Outcome|Placebo 0-4 Hours-baseline|Placebo 0-4 hours baseline
762216|NCT01550809|O2|Outcome|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
762217|NCT01550809|O1|Outcome|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
762218|NCT01550809|E2|Reported Event|iBolus (CGM-based Insulin Administration)|This is a continuous glucose monitoring (CGM)-based algorithm for prandial insulin administration. An individual patient's model characterizing a 5-hour postprandial period (0-5h PP) is obtained from a 6-day CGM period. A model with interval parameters accounting for patient's variability is calculated considering 20% uncertainty in insulin sensitivity and 10% in carbohydrates (CHO) estimation. Based on this model, constraints on plasma glucose are posed and a set-inversion problem lead to a set of solutions (the iBolus) that contains a bolus insulin dose, a specific mealtime basal insulin dose and the time for restoration of basal to baseline values.
762219|NCT01550809|E1|Reported Event|tBolus (Traditional Bolus)|Traditional mealtime bolus based on the individual insulin-to-CHO ratio
762220|NCT01550744|B1|Baseline|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
762221|NCT01550744|P3|Participant Flow|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
762222|NCT01550744|P2|Participant Flow|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
762223|NCT01550744|P1|Participant Flow|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
762224|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
762225|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
762226|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
762227|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
763010|NCT01545765|O3|Outcome|Lidocaine 7% + Tetracaine 7% Thigh - First Application Time|
762228|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
762229|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
762254|NCT01550302|B1|Baseline|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
763051|NCT01545700|O6|Outcome|Dexamethasone 8 mg 8-24 Hours|
762230|NCT01550744|O2|Outcome|Group 2: Ustekinumab Subject-tailored Fixed-interval MR|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection (sc) of 45 mg or placebo and participants who weighed > 100 kg received 2 sc injections of ustekinumab 45 mg or placebo.
762231|NCT01550744|O1|Outcome|Group 1: Ustekinumab q12w Maintenance Regimen (MR)|Randomized double-blind period (Week 28-124) - Participants who weighed less than or equal to (<=) 100 kilograms (kg) received 1 ustekinumab subcutaneous injection of 45 milligram (mg) or placebo and participants who weighed > 100 kg received 2 subcutaneous injections of ustekinumab 45 mg or placebo.
762232|NCT01550744|E3|Reported Event|Group 2: Subject-tailored Fixed-interval Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants did not receive a dose of ustekinumab at Week 28. Individual subject-tailored fixed-interval maintenance regimens were determined by observing physician global assessment (PGA) responses from Week 32 through Week 40. The interval separating maintenance doses for each participant was determined by time to loss of PGA response (defined as PGA score of greater than or equal to [>=2]). Participants who weighed <= 100 kg received 1 ustekinumab SC of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
762233|NCT01550744|E2|Reported Event|Group 1: Approved q12w Maintenance Regimen|Randomized double-blind period (Week 28-124) - Participants who weighed <= 100 kg received 1 ustekinumab SC injection of 45 mg or placebo and participants who weighed > 100 kg received 2 SC injections of ustekinumab 45 mg or placebo.
762234|NCT01550744|E1|Reported Event|Ustekinumab 45 mg/Ustekinumab 90 mg|Open-label period (Week 0-28) - ustekinumab subcutaneous (SC) injections of 45 milligram (mg) at Week 0, 4 and 16 for participants with weight less than or equal to (<=) 100 kilograms (kg) at Week 0 or 90 mg at Week 0, 4, and 16 for participants with weight greater than (>) 100 kg at Week 0.
762235|NCT01550705|B1|Baseline|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
762236|NCT01550705|P1|Participant Flow|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
762237|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
762238|NCT01550705|O1|Outcome|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
762239|NCT01550705|E1|Reported Event|Isoniazid|"Subjects will receive isoniazid daily for 2 months. Subjects will be seen every 2 weeks to obtain lab samples and health check.~Isoniazid: Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months."
762240|NCT01550549|B1|Baseline|Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan (59 from study A07/A16 and 92 from study A05)
762241|NCT01550549|P1|Participant Flow|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
762242|NCT01550549|O1|Outcome|Autopsy Within One Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
762243|NCT01550549|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 year of scan
762244|NCT01550549|O1|Outcome|All Autopsy Population|
762245|NCT01550549|O1|Outcome|All Florbetapir-PET Scans|All subjects with a valid florbetapir-PET scan
762246|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
762247|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
762248|NCT01550549|O2|Outcome|Autopsy Within One Year of Scan|Subjects with a valid florbetapir-PET scan and autopsy (only those who deceased less than 12 months after the scan)
762249|NCT01550549|O1|Outcome|All Autopsy|Subjects with a valid florbetapir-PET scan and autopsy (including those who deceased more than 12 months after the scan)
762250|NCT01550549|O1|Outcome|Florbetapir-PET Scans Primary Analysis Group|
762251|NCT01550549|E1|Reported Event|Florbetapir-PET Scans|All subject scans with a valid florbetapir-PET scan
762252|NCT01550302|B3|Baseline|Total|Total of all reporting groups
762278|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762279|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762280|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762281|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762282|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762253|NCT01550302|B2|Baseline|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
762293|NCT01550289|E1|Reported Event|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762294|NCT01549977|B3|Baseline|Total|Total of all reporting groups
762255|NCT01550302|P2|Participant Flow|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
762256|NCT01550302|P1|Participant Flow|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
762257|NCT01550302|O2|Outcome|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
762258|NCT01550302|O1|Outcome|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
762259|NCT01550302|E2|Reported Event|Superficial Cervical Plexus Block|"Subjects enrolled in this group will have a line drawn and will receive a superficial cervical plexus block at the end of the surgery just prior to emergence from anesthesia.~Superficial Cervical Plexus Block: At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site.~Bupivacaine: Single dose of 37.5 mg of bupivacaine subcutaneously"
762260|NCT01550302|E1|Reported Event|Controls|Subjects enrolled in this group will only have a line drawn on the side of their neck for superficial cervical plexus block, but we will not perform the injection. The subjects will not be aware whether they received an intra-operative block or not. In addition, neither the Post-Anesthesia Care Unit nurse nor the providers involved in the post-operative care will be aware of subjects group assignment.
762261|NCT01550289|B3|Baseline|Total|Total of all reporting groups
762262|NCT01550289|B2|Baseline|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762263|NCT01550289|B1|Baseline|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762264|NCT01550289|P2|Participant Flow|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762265|NCT01550289|P1|Participant Flow|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762266|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
762267|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
762268|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762269|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762270|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
762271|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
762272|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants who received 3 vaccinations of placebo vaccine.
762273|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants who received 3 vaccinations of the CYD Dengue Vaccine.
777572|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
762283|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762284|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762285|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762286|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762287|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762288|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762289|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762290|NCT01550289|O2|Outcome|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762291|NCT01550289|O1|Outcome|CYD Dengue Vaccine Group|Healthy adult participants received 3 vaccinations of the CYD Dengue Vaccine.
762292|NCT01550289|E2|Reported Event|Placebo Group|Healthy adult participants received 3 vaccinations of placebo vaccine.
762297|NCT01549977|P2|Participant Flow|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762298|NCT01549977|P1|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762299|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762300|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762301|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762302|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762303|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762304|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762305|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762306|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762307|NCT01549977|O2|Outcome|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762308|NCT01549977|O1|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762309|NCT01549977|E2|Reported Event|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 12 weeks.
762310|NCT01549977|E1|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, tablets, orally, once daily for up to 12 weeks.
762311|NCT01549964|B5|Baseline|Total|Total of all reporting groups
762312|NCT01549964|B4|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762313|NCT01549964|B3|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762314|NCT01549964|B2|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762315|NCT01549964|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762316|NCT01549964|P4|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762317|NCT01549964|P3|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762318|NCT01549964|P2|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762360|NCT01549925|E1|Reported Event|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
762361|NCT01549873|B3|Baseline|Total|Total of all reporting groups
763011|NCT01545765|O2|Outcome|Lidocaine 7% + Tetracaine 7% Face - Second Application Time|
762319|NCT01549964|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762320|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762321|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762322|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762323|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762324|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762325|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762326|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762327|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762328|NCT01549964|O4|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762329|NCT01549964|O3|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762330|NCT01549964|O2|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762331|NCT01549964|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762332|NCT01549964|E4|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762333|NCT01549964|E3|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762334|NCT01549964|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg, tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
763012|NCT01545765|O1|Outcome|Lidocaine 7% + Tetracaine 7% Face - First Application Time|
762335|NCT01549964|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Sitagliptin placebo-matching tablets, orally, once daily for a 24-week Treatment Period followed by an optional 80-week extension period for up to 104 weeks of treatment. Metformin ≥1500 mg or Maximum Tolerated Dose (MTD) needs to continue at a stable dose.
762336|NCT01549951|B1|Baseline|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762337|NCT01549951|P1|Participant Flow|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762338|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762339|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
763052|NCT01545700|O5|Outcome|Dexamethasone 4 mg 8-24 Hours|
762340|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762341|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762342|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762343|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762344|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762345|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762346|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762347|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762348|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762349|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762350|NCT01549951|O1|Outcome|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762351|NCT01549951|E1|Reported Event|Orteronel + Prednisone|Orteronel 400 mg, tablets, orally, twice daily along with prednisone 5 mg, tablets, orally, twice daily for 2 treatment cycles of 28 days each. Gonadotropin-releasing hormone analogue therapy was supplied as a commercially available dosage formulation.
762352|NCT01549925|B3|Baseline|Total|Total of all reporting groups
762353|NCT01549925|B2|Baseline|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
762354|NCT01549925|B1|Baseline|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
762355|NCT01549925|P2|Participant Flow|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
762356|NCT01549925|P1|Participant Flow|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
762357|NCT01549925|O2|Outcome|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
762358|NCT01549925|O1|Outcome|Standard Surgical Resection|"standard surgical resection using clamps and surgical ligatures~Standard Surgical resection: standard surgical resection using clamps and surgical ligatures"
762359|NCT01549925|E2|Reported Event|LIGASURE|"Resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon~LIGASURE: resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon"
762362|NCT01549873|B2|Baseline|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
762363|NCT01549873|B1|Baseline|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
762364|NCT01549873|P2|Participant Flow|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
762365|NCT01549873|P1|Participant Flow|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
762366|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
762367|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
762368|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
762369|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
762370|NCT01549873|O2|Outcome|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
762371|NCT01549873|O1|Outcome|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
762372|NCT01549873|E2|Reported Event|Inhaled Anesthesia|Desflurane: Desflurane adjusted to maintain the bispectral index at 40-60.
763053|NCT01545700|O4|Outcome|Placebo 8-24 Hours|
762373|NCT01549873|E1|Reported Event|Total Intravenous Anesthesia (TIVA)|propofol: Propofol adjusted to maintain the bispectral index at 40-60.
762374|NCT01549860|B3|Baseline|Total|Total of all reporting groups
762375|NCT01549860|B2|Baseline|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
762376|NCT01549860|B1|Baseline|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
762377|NCT01549860|P2|Participant Flow|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
762378|NCT01549860|P1|Participant Flow|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
762379|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
762380|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
762381|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
762382|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
762383|NCT01549860|O2|Outcome|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
762384|NCT01549860|O1|Outcome|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
762385|NCT01549860|E2|Reported Event|SC + Mist Therapy|"30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed plus non-contract low frequency ultrasound 3 x per week for 4 weeks.~MIST Therapy: Non-contact low frequency ultrasound therapy"
762386|NCT01549860|E1|Reported Event|Standard Care (SC)|30 to 40 mmHg compression, dressing for moist wound healing environment, debridement as needed. Minimum of one treatment per week and up to 3 times per week per investigator discretion for 4 weeks
762387|NCT01549613|B3|Baseline|Total|Total of all reporting groups
762388|NCT01549613|B2|Baseline|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
762389|NCT01549613|B1|Baseline|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
762390|NCT01549613|P2|Participant Flow|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
762391|NCT01549613|P1|Participant Flow|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
762392|NCT01549613|O2|Outcome|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
762393|NCT01549613|O1|Outcome|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
762394|NCT01549613|E2|Reported Event|Standard Treatment of Vancomycin|"Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.~Vancomycin: • Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours."
762395|NCT01549613|E1|Reported Event|Standard Treatment With Daptomycin|"Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol~Daptomycin: • Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol."
762396|NCT01549405|B3|Baseline|Total|Total of all reporting groups
762397|NCT01549405|B2|Baseline|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
762398|NCT01549405|B1|Baseline|Control Group|Control group: Group that without intercostal nerve block
762399|NCT01549405|P2|Participant Flow|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
762400|NCT01549405|P1|Participant Flow|Control Group|Control group: Group that without intercostal nerve block
763054|NCT01545700|O3|Outcome|Dexamethasone 8 mg 0-4 Hours|
762401|NCT01549405|O2|Outcome|Nerve Block|"Group that performing intercostal block~İntercostal nerve block : Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery."
762402|NCT01549405|O1|Outcome|Control Group|Control group: Group that without intercostal nerve block
762403|NCT01549405|O2|Outcome|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
762404|NCT01549405|O1|Outcome|Control|Group that without intercostal nerve block
762405|NCT01549405|E2|Reported Event|İntercostal Nerve Block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
762406|NCT01549405|E1|Reported Event|Control|Group that without intercostal nerve block
762407|NCT01549392|B3|Baseline|Total|Total of all reporting groups
762408|NCT01549392|B2|Baseline|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
762409|NCT01549392|B1|Baseline|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
762410|NCT01549392|P2|Participant Flow|DECT/MRS in Glioma Patients Not Receiving Avastin|"0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
762411|NCT01549392|P1|Participant Flow|DECT/MRS in Patients Receiving Avastin|"3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks"
762412|NCT01549392|O2|Outcome|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
762413|NCT01549392|O1|Outcome|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
762414|NCT01549392|E2|Reported Event|DECT/MRS in Glioma Patients Not Receiving Avastin|"15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
762415|NCT01549392|E1|Reported Event|DECT/MRS in Patients Receiving Avastin|"-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later~DECT: DECT at tumor progression and 3 months later~MR spectroscopy: MR spectroscopy at tumor progression and 3 months later"
762416|NCT01549340|B1|Baseline|Participants With AR|Participants with AR whose records were retrospectively reviewed
762417|NCT01549340|P1|Participant Flow|Participants With AR|Participants with AR whose records were retrospectively reviewed
762418|NCT01549340|O2|Outcome|Participants With AR Alone|Participants with AR alone who elected AIT and whose records were retrospectively reviewed
762419|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma who elected AIT and whose records were retrospectively reviewed
762420|NCT01549340|O1|Outcome|Participants With AR and Asthma|Participants with AR and asthma whose records were retrospectively reviewed
762421|NCT01549340|O2|Outcome|Participants With AR Who Discontinued SLIT|Participants with AR whose records were retrospectively reviewed and discontinued SLIT
762422|NCT01549340|O1|Outcome|Participants With AR Who Discontinued SCIT|Participants with AR whose records were retrospectively reviewed and discontinued SCIT
762423|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
762424|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
762425|NCT01549340|O1|Outcome|Participants With AR|Participants with AR whose records were retrospectively reviewed
762426|NCT01549340|E1|Reported Event|Participants With AR|Participants with AR whose records were retrospectively reviewed
762427|NCT01549275|B3|Baseline|Total|Total of all reporting groups
762428|NCT01549275|B2|Baseline|AJCC TNM Staging > = IIIB HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
762429|NCT01549275|B1|Baseline|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition)
762430|NCT01549275|P2|Participant Flow|AJCC TNM Staging > = IIIB HCC Patients|29 patients belonged to AJCC TNM staging > = IIIB.
762431|NCT01549275|P1|Participant Flow|AJCC TNM Staging < = IIIA HCC Patients|Tumor stage is based on the AJCC (American Joint Committee on Cancer) TNM staging system (2010, 7th edition). 76 patients with JACC TNM staging < = IIIA.
762432|NCT01549275|O5|Outcome|TNM Staging > = IIIB Patients Receiving Supportive Treatment|All patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree C or D.
762433|NCT01549275|O4|Outcome|TNM Staging > = IIIB Patients Receiving TACE|All patients belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree C.
762434|NCT01549275|O3|Outcome|TNM Staging < = IIIA Patients Receiving Supportive Treatment|5 patients belonged to BCLC (Barcelona Clinic Liver Cancer classification) degree B and the other 4 patients belonged to BCLC degree C or D.
762435|NCT01549275|O2|Outcome|TNM Staging < = IIIA Patients Receiving TACE|All patients belonged to Child A classification and BCLC(Barcelona Clinic Liver Cancer classification) degree A or B.
762436|NCT01549275|O1|Outcome|TNM Staging < = IIIA Patients Receiving Curative Treatment|All patient belonged to Child A classification and BCLC (Barcelona Clinic Liver Cancer classification) degree A (14 patients) or B (8 patients).
762437|NCT01549275|O2|Outcome|AJCC TNM Staging < = IIIA HCC Patients|
762438|NCT01549275|O1|Outcome|AJCC TNM Staging > = IIIB|
762852|NCT01546636|E2|Reported Event|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
762439|NCT01549275|E1|Reported Event|HCC Patients Underwent FNA of Tumor|Patients who had residual specimens obtained from ultrasound-guided fine-needle aspiration of hepatic tumor measuring equal or larger than 3cm were included. The residual specimens were applied for primary culture and no additional aspiration of the tumor was performed solely for the collection of specimens for culture. Serious and other Adverse Events were not collected/assessed.
762440|NCT01549041|B3|Baseline|Total|Total of all reporting groups
762441|NCT01549041|B2|Baseline|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
762442|NCT01549041|B1|Baseline|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
762443|NCT01549041|P2|Participant Flow|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
762444|NCT01549041|P1|Participant Flow|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
762445|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
762446|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
762447|NCT01549041|O2|Outcome|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
762448|NCT01549041|O1|Outcome|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
762449|NCT01549041|E2|Reported Event|Asenapine 5 mg Twice Daily|"Patients will receive asenapine 5 mg daily in the morning and 5 mg daily in the evening~Asenapine 5 mg twice daily: Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily"
762450|NCT01549041|E1|Reported Event|Asenapine 10 mg Daily in the Evening|"Patients will receive their entire daily dose of asenapine as a single dose in the evening~Asenapine 10 mg once daily in the evening: The total daily dose of Asenapine will be given once daily in the evening"
762451|NCT01549002|B3|Baseline|Total|Total of all reporting groups
762452|NCT01549002|B2|Baseline|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
762453|NCT01549002|B1|Baseline|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
762454|NCT01549002|P2|Participant Flow|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
762455|NCT01549002|P1|Participant Flow|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
762599|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762456|NCT01549002|O2|Outcome|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
762457|NCT01549002|O1|Outcome|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
762486|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
762561|NCT01547715|P3|Participant Flow|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
762458|NCT01549002|E2|Reported Event|Intravenous Morphine|"Patients in this arm will receive intravenous morphine as their pre-I&D analgesic. The one time total dose to be used is 0.1 milligrams / kilogram, to a maximum of 8 milligrams. The medication will be delivered via slow IV push.~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intravenous Morphine: Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose"
762459|NCT01549002|E1|Reported Event|Intranasal Fentanyl|"Patients in this arm will receive intranasal Fentanyl (50 micrograms/mL) as their pre-I&D analgesic. The one time total dose to be used is 2 micrograms / kilogram, to a maximum of 100 micrograms. The medication will be delivered intranasally via an atomizer in 4 equally divided aliquots (2 per nare).~The abscess I&D will be followed according to protocol using topical and local anesthetic.~Intranasal Fentanyl: Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose"
762460|NCT01548885|B1|Baseline|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
762461|NCT01548885|P1|Participant Flow|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
762462|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
762463|NCT01548885|O1|Outcome|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
762464|NCT01548885|E1|Reported Event|Study Staff Test BGMSs|All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
762465|NCT01548833|B1|Baseline|Overall|DT1, TruEye, and Clariti contact lenses worn in randomized, cross-over fashion for one week each
762466|NCT01548833|P1|Participant Flow|Overall|All enrolled participants
762467|NCT01548833|O3|Outcome|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
762468|NCT01548833|O2|Outcome|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
762469|NCT01548833|O1|Outcome|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
762470|NCT01548833|E3|Reported Event|Clariti|Filcon II 3 contact lenses worn for one week in a daily wear, daily disposable manner.
762471|NCT01548833|E2|Reported Event|TruEye|Narafilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
762472|NCT01548833|E1|Reported Event|Dailies Total 1|Delefilcon A contact lenses worn for one week in a daily wear, daily disposable manner.
762473|NCT01548742|B3|Baseline|Total|Total of all reporting groups
762474|NCT01548742|B2|Baseline|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
762475|NCT01548742|B1|Baseline|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762476|NCT01548742|P2|Participant Flow|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
762477|NCT01548742|P1|Participant Flow|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762478|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
762479|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762480|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
763013|NCT01545765|E1|Reported Event|Lidocaine 7% + Tetracaine 7%|
762481|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762482|NCT01548742|O2|Outcome|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
762483|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762484|NCT01548742|O2|Outcome|Arm 2: Present Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
762485|NCT01548742|O1|Outcome|Arm 1: Mindfulness Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762487|NCT01548742|O1|Outcome|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762488|NCT01548742|E2|Reported Event|Arm 2: Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT): Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
762489|NCT01548742|E1|Reported Event|Arm 1: Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR): Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
762490|NCT01548638|B1|Baseline|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
762491|NCT01548638|P1|Participant Flow|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
762492|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
762493|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
762494|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
762495|NCT01548638|O1|Outcome|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
762496|NCT01548638|E1|Reported Event|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.~Galantamine ER : The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
762497|NCT01548573|B1|Baseline|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
762498|NCT01548573|P1|Participant Flow|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
762499|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
762500|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
762501|NCT01548573|O1|Outcome|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
762787|NCT01546688|B1|Baseline|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
762502|NCT01548573|O1|Outcome|Tandem Autologous Stem Cell Transplant|"Induction and PBSC Collection:1 cycle of combination D-PACE (and peripheral blood stem cell collection. After collection, participants may receive interim dexamethasone at 20mg days 1-4 every 14 days.~Transplant 1: 6 weeks after first day of D-PACE , but can occur as early as 4 weeks and as late as 6 months. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Transplant 2: 8 weeks-6 months after the first transplant, participants will have second transplant. Once recovered, participants start thalidomide daily and dexamethasone x 4 days every 21 days.~Consolidation Phase (if administered): 4 weeks-4 months after second transplant, participants may receive consolidation chemotherapy.~Maintenance Phase year 1 and 2:The first year of maintenance will commence between 6 weeks-6 months after consolidation or 4 weeks-6 months after transplant if consolidation is skipped.~DP"
762503|NCT01548573|E1|Reported Event|Tandem Transplant in MM <12 Mos of Prior Treatment|This was a single arm study for myeloma patients with <12 months of prior treatment to determine whether the incorporation of bortezomib into a tandem transplant regimen followed by 2 years of maintenance therapy would increase event-free survival.
762504|NCT01548417|B3|Baseline|Total|Total of all reporting groups
762505|NCT01548417|B2|Baseline|Placebo|Sugar Pill: placebo, oral pill, 7 days
762506|NCT01548417|B1|Baseline|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
762507|NCT01548417|P2|Participant Flow|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
762508|NCT01548417|P1|Participant Flow|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
762509|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
762510|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
762511|NCT01548417|O2|Outcome|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
762512|NCT01548417|O1|Outcome|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
762513|NCT01548417|E2|Reported Event|Sugar Pill|Sugar Pill: placebo, oral pill, 7 days
762514|NCT01548417|E1|Reported Event|Korlym (Mifepristone)|Korlym (mifepristone): 600 mg/day, oral pill, 7 days
762515|NCT01548287|B5|Baseline|Total|Total of all reporting groups
762516|NCT01548287|B4|Baseline|Placebo|Placebo daily
762517|NCT01548287|B3|Baseline|AZD5213 Dose C|AZD5213 6.0 mg daily
762518|NCT01548287|B2|Baseline|AZD5213 Dose B|AZD 5213 2.0 mg daily
762519|NCT01548287|B1|Baseline|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762520|NCT01548287|P5|Participant Flow|Screening Only|Screening period only, not randomized
762521|NCT01548287|P4|Participant Flow|Placebo|Placebo daily
762522|NCT01548287|P3|Participant Flow|AZD5213 Dose C|AZD5213 6.0 mg daily
762523|NCT01548287|P2|Participant Flow|AZD5213 Dose B|AZD 5213 2.0 mg daily
762524|NCT01548287|P1|Participant Flow|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762525|NCT01548287|O4|Outcome|Placebo|Placebo daily
762526|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
762527|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
762528|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762529|NCT01548287|O4|Outcome|Placebo|Placebo daily
762530|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
762531|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
762532|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762533|NCT01548287|O4|Outcome|Placebo|Placebo daily
762534|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
762535|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
762536|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762537|NCT01548287|O4|Outcome|Placebo|Placebo daily
762538|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
762539|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
762540|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762541|NCT01548287|O4|Outcome|Placebo|Placebo daily
762542|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
762543|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
762544|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762545|NCT01548287|O4|Outcome|Placebo|Placebo daily
762546|NCT01548287|O3|Outcome|AZD5213 Dose C|AZD5213 6.0 mg daily
762547|NCT01548287|O2|Outcome|AZD5213 Dose B|AZD 5213 2.0 mg daily
762548|NCT01548287|O1|Outcome|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762549|NCT01548287|E4|Reported Event|Placebo|Placebo daily
762550|NCT01548287|E3|Reported Event|AZD5213 Dose C|AZD5213 6.0 mg daily
762551|NCT01548287|E2|Reported Event|AZD5213 Dose B|AZD 5213 2.0 mg daily
762552|NCT01548287|E1|Reported Event|AZD5213 Dose A|AZD5213 AZD 0.5 mg daily
762553|NCT01547728|B1|Baseline|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
762554|NCT01547728|P1|Participant Flow|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
762555|NCT01547728|O1|Outcome|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
762556|NCT01547728|E1|Reported Event|Recombinant Antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
762557|NCT01547715|B4|Baseline|Total|Total of all reporting groups
762558|NCT01547715|B3|Baseline|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1.
762559|NCT01547715|B2|Baseline|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1
762560|NCT01547715|B1|Baseline|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1
762562|NCT01547715|P2|Participant Flow|11 - 18 Years|Subjects between 11 and 18 years of age received one injection of MenACWY –CRM vaccine on day 1.
762563|NCT01547715|P1|Participant Flow|2 - 10 Years|Subjects between 2 and 10 years of age received one injection of MenACWY –CRM vaccine on day 1.
762564|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762565|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762566|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762567|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762568|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762569|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762570|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762571|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762572|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762573|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762574|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762575|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762576|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762577|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762578|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762579|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762580|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762581|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762582|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762583|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762584|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762585|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762586|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762587|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762588|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762589|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762590|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762591|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762592|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762593|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762594|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762595|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762596|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762597|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762598|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762600|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762601|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762602|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762603|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762604|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762605|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762606|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762607|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762608|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762850|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
762609|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762610|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762611|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762612|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762613|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762614|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762615|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762616|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762617|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762618|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762619|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762620|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762621|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762622|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762623|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762624|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762625|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762626|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762627|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762628|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762629|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762630|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762631|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762632|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762633|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762634|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762635|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762636|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762637|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762638|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762639|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762640|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762641|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762642|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762643|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762644|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762645|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
763014|NCT01545700|B7|Baseline|Total|Total of all reporting groups
762646|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762647|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762648|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762649|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762650|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762651|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762652|NCT01547715|O4|Outcome|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762653|NCT01547715|O3|Outcome|19 - 75 Years|Subjects between 19 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762654|NCT01547715|O2|Outcome|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762655|NCT01547715|O1|Outcome|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762656|NCT01547715|E4|Reported Event|Overall (≥2 Years)|Subjects between 2 and 75 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762657|NCT01547715|E3|Reported Event|19 - 75 Years|Subjects between 19 and 75 years of age received one injection of MenACWY –CRM vaccine on day 1
762658|NCT01547715|E2|Reported Event|11 - 18 Years|Subjects between 11 and 18 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762659|NCT01547715|E1|Reported Event|2 - 10 Years|Subjects between 2 and 10 years of age who received one injection of MenACWY –CRM vaccine on day 1.
762660|NCT01547598|B3|Baseline|Total|Total of all reporting groups
762661|NCT01547598|B2|Baseline|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762662|NCT01547598|B1|Baseline|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762663|NCT01547598|P2|Participant Flow|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762664|NCT01547598|P1|Participant Flow|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762665|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762666|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762667|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762668|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762669|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762670|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762671|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762672|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762673|NCT01547598|O2|Outcome|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762674|NCT01547598|O1|Outcome|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762675|NCT01547598|E3|Reported Event|DuoTrav®|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
762720|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762676|NCT01547598|E2|Reported Event|LUMIGAN® RC|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks. Then, LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
762677|NCT01547598|E1|Reported Event|Travatan® Z|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks for all participants.
762678|NCT01547299|B3|Baseline|Total|Total of all reporting groups
762679|NCT01547299|B2|Baseline|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762680|NCT01547299|B1|Baseline|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762681|NCT01547299|P2|Participant Flow|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762682|NCT01547299|P1|Participant Flow|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762683|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762684|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762685|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762686|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762687|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762688|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762689|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762690|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762691|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762692|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762693|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762694|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762695|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762696|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762697|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762698|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762699|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762700|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762701|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762702|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762703|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762704|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762705|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762706|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762707|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762708|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762709|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762710|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762711|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762712|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762713|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762714|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762715|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762716|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762717|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762718|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762719|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762722|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762723|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762724|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762725|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762726|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762727|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762728|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762729|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762730|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762731|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762732|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762733|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762734|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762735|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762736|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762737|NCT01547299|O2|Outcome|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762738|NCT01547299|O1|Outcome|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762739|NCT01547299|E2|Reported Event|Enzalutamide Alone|Enzalutamide 160 mg, orally, once daily
762740|NCT01547299|E1|Reported Event|Enzalutamide & Leuprolide & Dutasteride|Enzalutamide 160 mg, orally, once daily and leuprolide 22.5 mg, intramuscular injection, every 3 months, and dutasteride, 0.5 mg, orally, once daily
762741|NCT01547286|B1|Baseline|Allergic Asthmatic|Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge. Nebulized methacholine inhalation: Standard
762742|NCT01547286|P1|Participant Flow|Allergic Asthmatic|This is a single physiological group study where each subject served as their own control. All eligible subjects underwent a methacholine challenge test, clinical assessment and skin tests to ascertain the diagnosis of allergic asthma. Both methacholine and skin test results were used to determine the start dose of the bronchial allergen challenge test. CT and PET with Nitrogen-13 (13NN) saline as a radiotracer images were obtained during the early and late phases after allergen challenge.
762743|NCT01547286|O1|Outcome|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard"
762744|NCT01547286|O1|Outcome|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge Nebulized methacholine inhalation: Standard"
762776|NCT01546922|P1|Participant Flow|First a Low Dose of HC Followed by a High Dose of HC|First low dose of hydrocortisone = 0.2-0.3 mg/kg body weight for 10 weeks followed by a high dose of hydrocortisone = 0.4-0.6 mg/kg body weight
762777|NCT01546922|O2|Outcome|High Dose of Hydrocortisone|Results from the participants while receiving the high dose of hydrocortisone
762778|NCT01546922|O1|Outcome|Low Dose of Hydrocortisone|Results from the participants while receiving the low dose of hydrocortisone
762779|NCT01546922|E2|Reported Event|High Dose of HC|Administration of a high dose of hydrocortisone (0.4-0.6 mg/kg body weight) for 10 weeks
762745|NCT01547286|E1|Reported Event|Allergic Asthmatic|"Standardized Cat Allergen Extract and Standardized Dust Mite Allergen: The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated PC20-allergen delivered for 5 minutes at tidal breathing, followed by FEV1 at 10-minute intervals until the lowest FEV1 is established. If the %FEV1 fall is < 20%, the next concentration is given, until the FEV1 falls ≥ 20%. When this happens the FEV1 will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum %FEV1 fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.~CT imaging, functional PET imaging: Physiology study using CT and PET imaging with Nitrogen-13 (13NN) saline as radiotracer; images obtained during the early and late phases after allergen challenge"
762746|NCT01547247|B3|Baseline|Total|Total of all reporting groups
762747|NCT01547247|B2|Baseline|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762748|NCT01547247|B1|Baseline|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762749|NCT01547247|P2|Participant Flow|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762750|NCT01547247|P1|Participant Flow|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762751|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762752|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762753|NCT01547247|O2|Outcome|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762754|NCT01547247|O1|Outcome|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762755|NCT01547247|E2|Reported Event|Water Immersion Colonoscopy|Standard colonoscopy without attached cap using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762756|NCT01547247|E1|Reported Event|Cap-assisted Water Immersion Colonoscopy|Cap-fitted colonoscopy using purely water immersion during colonoscope insertion and room air insufflation during colonoscope withdrawal.
762757|NCT01547130|B3|Baseline|Total|Total of all reporting groups
762758|NCT01547130|B2|Baseline|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
762759|NCT01547130|B1|Baseline|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
762760|NCT01547130|P2|Participant Flow|HalfLytely Colon Prep (HCP)|Patients followed the preparation method according to the manufacturer's standard instructions.
762761|NCT01547130|P1|Participant Flow|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
762762|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
762763|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
762764|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions. Subjects recorded adverse events.
762765|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Patients take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses. Adverse events were recorded on questionnaire.
762766|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Subjects rated the HCP as palatable
762767|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Subjects rated the SCC as palatable
762768|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Solution palatability of HCP by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
762769|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Solution palatability of SCC by subjects based on 1-5 scale (1-not palatable and 5-Palatable). A questionnaire was used to collect the data.
762770|NCT01547130|O2|Outcome|HalfLytely Colon Prep (HCP) Group|Patients in the HCP group followed the preparation method according to the manufacturer's standard instructions. Patients were instructed to stay on clear liquids the entire day before the colonoscopy. Two tablets of bisacodyl delayed-release tablets with water were taken at around 1:00 pm. Patients were instructed to start drinking the solution after a bowel movement or around 7 pm if no bowel activity occurred. They were instructed to sip all of the solution at a rate of 8 oz. every 10 minutes.
762771|NCT01547130|O1|Outcome|Shudh Colon Cleanse (SCC) Group|Yoga contained a 32-oz plastic pitcher and 9-gm salt sachets (Iodine-free table salt - USP grade sodium chloride) for preparation of 0.9% saline (1 sachet in 32-oz lukewarm water (37.2-38.8 degrees Centigrade or 99-102 degrees Fahrenheit)), an instructional leaflet, and a DVD providing instructions of the bowel preparation process. Patients were instructed to fill the pitcher with 16-oz of hot water and 16-oz of room temperature water to reach the lukewarm temperature. Patients could add a twist of lemon if the solution was unpalatable to them.
762772|NCT01547130|E2|Reported Event|HalfLytely Colon Prep (HCP) Group|Patients followed the preparation method according to the manufacturer's standard instructions.
762773|NCT01547130|E1|Reported Event|Shudh Colon Cleanse (SCC) Group|Patients will take a bolus intake of 8 oz. (240mL) to 16 oz. (480mL) of lukewarm saline water and perform yoga poses.
762774|NCT01546922|B1|Baseline|All Participants|All participants completing both study periods
762775|NCT01546922|P2|Participant Flow|First a High Dose of HC Followed by a Low Dose of HC|First high dose of hydrocortisone = 0.4-0.6 mg/kg body weight for 10 weeks followed by a low dose of hydrocortisone = 0.2-0.3 mg/kg body weight
762780|NCT01546922|E1|Reported Event|Low Dose of HC|Administration of a low dose of hydrocortisone (0.2-0.3 mg/kg body weight) for 10 weeks
762781|NCT01546883|B1|Baseline|Dabigatran|Dabigatran
762782|NCT01546883|P1|Participant Flow|Dabigatran|"Patients with Atrial fibrillation taking Dabigatran etexilate as the anti-coagulant~Dabigatran etexilate (Pradaxa): 150mg bid or 75mg bid for a period of one year"
762783|NCT01546883|O1|Outcome|Dabigatran|Dabigatran
762784|NCT01546883|E1|Reported Event|Dabigatran|Patients taking Dabigatran
762785|NCT01546688|B3|Baseline|Total|Total of all reporting groups
762786|NCT01546688|B2|Baseline|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
762788|NCT01546688|P2|Participant Flow|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
762789|NCT01546688|P1|Participant Flow|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
762790|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
762791|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
762792|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
762793|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
762794|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
762795|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
762796|NCT01546688|O2|Outcome|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
762797|NCT01546688|O1|Outcome|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
762798|NCT01546688|E2|Reported Event|Zonisamide|Subjects started the Titration Period on a Total Daily Dose (TDD) of zonisamide 50mg (25mg capsules twice daily in the morning and evening) for a total of 8 weeks. Doses increased in 100mg increments up to a targeted TDD of 300mg with a range of 100mg to 500mg. Subjects entered the Maintenance Period on the same dose they were on at the end of the titration phase, taking the dose once daily (in the evening) or twice daily for a total of 8 weeks. Subjects were withdrawn if they required a TDD outside of the suggested range.
762799|NCT01546688|E1|Reported Event|Placebo|Subjects took matching doses of placebo during both the Titration Period and Maintenance Period.
762800|NCT01546675|B3|Baseline|Total|Total of all reporting groups
762801|NCT01546675|B2|Baseline|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design
762802|NCT01546675|B1|Baseline|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
762803|NCT01546675|P2|Participant Flow|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
762804|NCT01546675|P1|Participant Flow|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
762805|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
762806|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
763599|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
762807|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
762808|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
762809|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
762810|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
762811|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
762851|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
762812|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
762813|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
762814|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|.Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
762815|NCT01546675|O2|Outcome|Experimental: Skeletal Stabilization 1, Traditional 2|Subjects using the Skeletal Stabilization Socket in the first 2 weeks and then the Traditional Socket in the second two weeks in a case cross-over design.
762816|NCT01546675|O1|Outcome|Active Comparator: Traditional 1, Skeletal Stabilization 2|Subjects using the Traditional Socket in the first 2 weeks and then the socket hypothesized to increase Skeletal Stabilization in the second two weeks in a case cross-over design.
762817|NCT01546675|E1|Reported Event|Cases|Subjects using the Traditional Socket and socket hypothesized to increase skeletal stabilization in a case cross-over design.
762818|NCT01546649|B3|Baseline|Total|Total of all reporting groups
762819|NCT01546649|B2|Baseline|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762820|NCT01546649|B1|Baseline|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762821|NCT01546649|P2|Participant Flow|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762822|NCT01546649|P1|Participant Flow|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762823|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762824|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762825|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762826|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762827|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762828|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762829|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762830|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762831|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762832|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762833|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762834|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762835|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762836|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762837|NCT01546649|O2|Outcome|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762838|NCT01546649|O1|Outcome|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762839|NCT01546649|E2|Reported Event|TAP-144-SR (3M)|TAP-144-SR (3M) 11.25 mg, injection, subcutaneous, once in 12 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
763023|NCT01545700|P4|Participant Flow|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
762840|NCT01546649|E1|Reported Event|TAP-144-SR (6M)|TAP-144-SR (6M) 22.5 milligram (mg), injection, subcutaneous, once in 24 weeks along with tamoxifen 20 mg, tablet, orally, once daily for up to 96 weeks.
762841|NCT01546636|B3|Baseline|Total|Total of all reporting groups
762842|NCT01546636|B2|Baseline|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
762843|NCT01546636|B1|Baseline|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
762844|NCT01546636|P2|Participant Flow|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
762845|NCT01546636|P1|Participant Flow|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
762846|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
762847|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
762848|NCT01546636|O2|Outcome|Normocapnic Group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
762849|NCT01546636|O1|Outcome|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
762853|NCT01546636|E1|Reported Event|Hypocapnic Group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
762854|NCT01546623|B3|Baseline|Total|Total of all reporting groups
762855|NCT01546623|B2|Baseline|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762856|NCT01546623|B1|Baseline|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762857|NCT01546623|P2|Participant Flow|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762858|NCT01546623|P1|Participant Flow|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762859|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762860|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762861|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762862|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762863|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762864|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762865|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762866|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762867|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762868|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762869|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762870|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762871|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762872|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762873|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762874|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762875|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762876|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762877|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762878|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762879|NCT01546623|O2|Outcome|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762880|NCT01546623|O1|Outcome|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762881|NCT01546623|E2|Reported Event|TAP-144-SR(3M)|TAP-144-SR(3M) 11.25 mg, injection, treatment interval 12 weeks for up to 48 weeks.
762882|NCT01546623|E1|Reported Event|TAP-144-SR(6M)|TAP-144-SR(6M) 22.5 mg, injection, treatment interval 24 weeks for up to 48 weeks.
762883|NCT01546519|B5|Baseline|Total|Total of all reporting groups
762884|NCT01546519|B4|Baseline|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762885|NCT01546519|B3|Baseline|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
763015|NCT01545700|B6|Baseline|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
763205|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
762886|NCT01546519|B2|Baseline|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762887|NCT01546519|B1|Baseline|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762973|NCT01546142|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762974|NCT01546142|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762888|NCT01546519|P4|Participant Flow|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762889|NCT01546519|P3|Participant Flow|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762890|NCT01546519|P2|Participant Flow|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762891|NCT01546519|P1|Participant Flow|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
762892|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762893|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762894|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762895|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
762896|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762897|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
763016|NCT01545700|B5|Baseline|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
763017|NCT01545700|B4|Baseline|Placebo Comparator Saline 8-24 Hours|"placebo, 2 cc saline~Control saline : Patients are randomized to receive saline 2 cc"
777573|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
762898|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762899|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
762900|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762901|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762902|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762903|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
762904|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762905|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762906|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60 Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762907|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water.
762908|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762909|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
763018|NCT01545700|B3|Baseline|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
763019|NCT01545700|B2|Baseline|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
777574|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
762910|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762911|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762912|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762913|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762914|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762915|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762916|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762917|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762918|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762919|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762920|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762921|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
763020|NCT01545700|B1|Baseline|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
763021|NCT01545700|P6|Participant Flow|Dexamethasone 8 mg, 8-24 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients are randomized to receive dexamethasone 8 mg"
763460|NCT01544179|E1|Reported Event|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
762922|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762923|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762924|NCT01546519|O4|Outcome|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762925|NCT01546519|O3|Outcome|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762926|NCT01546519|O2|Outcome|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762927|NCT01546519|O1|Outcome|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762928|NCT01546519|E4|Reported Event|Severe Hepatic Impairment and Normal Renal Function (Sev HI)|"Participants with severe hepatic impairment and normal renal function were included.~Severe hepatic impairment is defined as 3×ULN<TB<10×ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762929|NCT01546519|E3|Reported Event|Moderate Hepatic Impairment and Normal Renal Function (Mod HI)|"Participants with moderate hepatic impairment and normal renal function were included.~Moderate hepatic impairment was defined as 1.5 × ULN< TB<3× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762930|NCT01546519|E2|Reported Event|Mild Hepatic Impairment and Normal Renal Function (Mild HI)|"Participants with mild hepatic impairment and normal renal function were included.~Mild Hepatic was defined as = TB<=ULN, AST>ULN; OR ULN<TB<=1.5× ULN, AST any Normal renal function was defined as BSA - indexed CrCl (mL/min) = / >= 60. Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762931|NCT01546519|E1|Reported Event|Control Cohort With Normal Renal and Normal Hepatic Function|"Participants with normal renal and normal hepatic function were included. Normal renal function was defined as Body Surface Area (BSA) - indexed creatinine clearance (CrCl) (mL/min) = / >= 60 Normal hepatic function was indicated by total bilirubin (TB) <= upper limit of normal (ULN) range and aspartate transaminase (AST) <= ULN.~Participants were administered 150 mg oral vismodegib once daily for 8 consecutive days (Day 1 to Day 7 doses were taken with or without food; Day 8 dose was administered on an empty stomach) at approximately the same time with about 240 mL of water."
762932|NCT01546454|B1|Baseline|All Study Participants|
762933|NCT01546454|P1|Participant Flow|All Study Participants|
762934|NCT01546454|O3|Outcome|Steroid Effects|"Estrogen/Progesterone replacement cycle versus Eligard treatment. Interventions include leuprolide acetate, estradiol, and progesterone.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
762935|NCT01546454|O2|Outcome|Contraceptive Effects|"Oral contraceptive cycle versus Eligard treatment. Interventions include ethinyl estradiol-levonorgestrel combination and leuprolide acetate.~Ethinyl Estradiol-Levonorgestrel combination: 0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days~leuprolide acetate: single 22.5 mg subcutaneous depot suspension"
762936|NCT01546454|O1|Outcome|Non-steroidal Effects|"Natural menstrual cycle versus Estrogen/Progesterone replacement cycle. Interventions include leuprolide acetate to induce hypogonadism and estradiol and progesterone to replace hormone levels.~leuprolide acetate: single 22.5 mg subcutaneous depot suspension~Estradiol: 0.05 to 0.3 mg transdermal daily for 26 days~Progesterone: 50 to 100 mg vaginal suppositories twice daily for 13 days"
762937|NCT01546454|E1|Reported Event|All Study Participants|
762938|NCT01546402|B3|Baseline|Total|Total of all reporting groups
762939|NCT01546402|B2|Baseline|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
762975|NCT01546142|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763055|NCT01545700|O2|Outcome|Dexamethasone 4 mg 0-4 Hours|
762940|NCT01546402|B1|Baseline|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
762941|NCT01546402|P2|Participant Flow|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
762942|NCT01546402|P1|Participant Flow|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
762943|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
762944|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
762945|NCT01546402|O2|Outcome|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
762968|NCT01546155|B1|Baseline|Healthy Volunteers|The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale. The additional scan session for subjects will be performed under no pain, “control” conditions.
763022|NCT01545700|P5|Participant Flow|Dexamethasone 4 mg, 8-24 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients are randomized to receive dexamethasone 4 mg and saline 1 cc"
762969|NCT01546155|P1|Participant Flow|Healthy Volunteers|The PET/fMRI scan session will last up to 120 minutes. Subjects will have 2 MR-PET scan sessions, each lasting up to 120 minutes, with a break between scan sessions. Approximately nine venous blood samples will be taken per scan session with a maximum of 48mL of blood drawn per scan session. Intermittent cuff pain, based on the previously determined Strong ratings, will be applied during one of the two scan sessions. Subjects will rate the pain they feel as a result of the cuff stimuli using the Gracely scale.
762970|NCT01546155|O1|Outcome|Healthy Controls|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
762971|NCT01546155|E1|Reported Event|Healthy Volunteers|PET imaging: Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
762972|NCT01546142|B3|Baseline|Total|Total of all reporting groups
762946|NCT01546402|O1|Outcome|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
762947|NCT01546402|E2|Reported Event|Phacoemulsification With Ozurdex|"This group (Group A) includes patients who will undergo phacoemulsification with intraocular lens implantation with intraoperative long acting steroid injection (Ozurdex ®). The dexamethasone implant will be injected at the beginning of cataract surgery, 4mm from the limbus using the specially designed injector. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Dexamethasone Drug delivery system (Ozurdex): It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration)."
762948|NCT01546402|E1|Reported Event|Phacoemulsification With IOL Implant|"This group (Group B) includes patients who will undergo phacoemulsification with intraocular lens implantation. The dexamethasone implant will not be injected at the beginning of cataract surgery. Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.~Cataract surgery: Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy."
762949|NCT01546285|B1|Baseline|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
762950|NCT01546285|P1|Participant Flow|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
762951|NCT01546285|O3|Outcome|B40 and PRO1000 - MAP|
762952|NCT01546285|O2|Outcome|B40 and PRO1000 - Diastolic BP|
762953|NCT01546285|O1|Outcome|B40 and PRO1000 - Systolic BP|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
762954|NCT01546285|E1|Reported Event|Blood Pressure Reading|Simultaneous blood pressure readings with DINAMAP PRO1000 and B40 monitor; total of 6 successful readings
762955|NCT01546207|B1|Baseline|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
762956|NCT01546207|P1|Participant Flow|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
762957|NCT01546207|O1|Outcome|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
762958|NCT01546207|E1|Reported Event|Catheter-based Ablation|catheter ablation - a medical procedure used to treat some types of arrhythmia
762959|NCT01546194|B3|Baseline|Total|Total of all reporting groups
762960|NCT01546194|B2|Baseline|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
762961|NCT01546194|B1|Baseline|Morning Consent|"Consent process consisting of information only provided on the morning of surgery~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
762962|NCT01546194|P2|Participant Flow|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
762963|NCT01546194|P1|Participant Flow|Morning Consent|Consent process consisting of information only provided on the morning of surgery
762964|NCT01546194|O2|Outcome|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
762965|NCT01546194|O1|Outcome|Morning Consent|Consent process consisting of information only provided on the morning of surgery
762966|NCT01546194|E2|Reported Event|Phone Call and Morning Consent|"Consent process consisting of information provided on the morning of surgery. In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project~Phone call explaining the research project: A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial"
762967|NCT01546194|E1|Reported Event|Morning Consent|Consent process consisting of information only provided on the morning of surgery
763001|NCT01545843|E2|Reported Event|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
763002|NCT01545843|E1|Reported Event|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762976|NCT01546142|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762977|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762978|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762979|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762980|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762981|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762982|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762983|NCT01546142|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762984|NCT01546142|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762985|NCT01546142|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762986|NCT01546142|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
762987|NCT01545843|B4|Baseline|Total|Total of all reporting groups
762988|NCT01545843|B3|Baseline|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; risetime advanced by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762989|NCT01545843|B2|Baseline|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling:6 hours time in bed for two weeks; bedtime delayed by 2 hours~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762990|NCT01545843|B1|Baseline|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762991|NCT01545843|P3|Participant Flow|Early Risetime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
762992|NCT01545843|P2|Participant Flow|Late Bedtime Sleep Deprivation|6 hours time in bed for two weeks plus fluoxetine for 8 weeks. Bedtime delayed by 2 hours.
762993|NCT01545843|P1|Participant Flow|No Sleep Deprivation|8 hours time in bed for two weeks plus fluoxetine for 8 weeks
762994|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762995|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay of bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762996|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours vs. 6 hours time in bed for two weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762997|NCT01545843|O3|Outcome|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour advance in risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762998|NCT01545843|O2|Outcome|Late Bedtime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, with 2 hour delay in bedtime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
762999|NCT01545843|O1|Outcome|No Sleep Deprivation|"8 hours time in bed plus medication~Sleep scheduling: 8 hours time in bed for 2 weeks~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
763000|NCT01545843|E3|Reported Event|Early Risetime Sleep Deprivation|"6 hours time in bed plus medication~Sleep scheduling: 6 hours time in bed for two weeks, two hour advance of risetime~Fluoxetine: 20-40 mg fluoxetine daily for 8 weeks"
763003|NCT01545765|B1|Baseline|Lidocaine 7% and Tetracaine 7%|
763004|NCT01545765|P1|Participant Flow|Face 2 Application Times/ Thight 2 Application Times|
763024|NCT01545700|P3|Participant Flow|Dexamethasone 8 mg, 0-4 Hours|"Dexamethasone 8 mg administered intraoperatively~Dexamethasone 8 mg : Patients randomized to receive dexamethasone 8mg"
763025|NCT01545700|P2|Participant Flow|Dexamethasone 4 mg, 0-4 Hours|"Dexamethasone 4 mg administered intraoperatively~Dexamethasone 4 mg : Patients randomized to receive dexamethasone 4mg and 1 cc saline"
763026|NCT01545700|P1|Participant Flow|Control, Saline 0-4 Hours|"2 cc of saline~Control-saline : Patients are randomized to receive saline 2 cc"
763027|NCT01545700|O24|Outcome|Dexamethasone 8 mg 8-24 Hours-24 Hours|
763028|NCT01545700|O23|Outcome|Dexamethasone 8 mg 8-24 Hours-8 Hours|
763029|NCT01545700|O22|Outcome|Dexamethasone 8 mg 8-24 Hours-baseline|
763030|NCT01545700|O21|Outcome|Dexamethasone 4 mg 8-24 Hours-24 Hours|
763031|NCT01545700|O20|Outcome|Dexamethasone 4 mg 8-24 Hours-8 Hours|
763032|NCT01545700|O19|Outcome|Dexamethasone 4 mg 8-24 Hours-baseline|
763033|NCT01545700|O18|Outcome|Placebo 8-24 Hours-24 Hours|
763034|NCT01545700|O17|Outcome|Placebo 8-24 Hours-8 Hours|
763035|NCT01545700|O16|Outcome|Placebo 8-24 Hours Baseline|
763036|NCT01545700|O15|Outcome|Dexamethasone 8 mg 0-4 Hours-4 Hours|
763037|NCT01545700|O14|Outcome|Dexamethasone 8 mg 0-4 Hours-3 Hours|
763038|NCT01545700|O13|Outcome|Dexamethasone 8 mg 0-4 Hours-2 Hours|
763057|NCT01545700|E2|Reported Event|Dexamethasone Group|either 4 mg or 8 mg
763058|NCT01545700|E1|Reported Event|Control-saline Group|
763059|NCT01545518|B1|Baseline|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
763060|NCT01545518|P1|Participant Flow|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
763061|NCT01545518|O1|Outcome|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover"
763062|NCT01545518|E1|Reported Event|All Subjects|"IVIG~IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover~No AE's."
763063|NCT01545388|B4|Baseline|Total|Total of all reporting groups
763064|NCT01545388|B3|Baseline|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
763065|NCT01545388|B2|Baseline|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
763066|NCT01545388|B1|Baseline|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
763067|NCT01545388|P3|Participant Flow|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
763068|NCT01545388|P2|Participant Flow|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
763069|NCT01545388|P1|Participant Flow|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
763070|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
763071|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
763072|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
763073|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
763074|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
763075|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
763076|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
763077|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
763078|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
763593|NCT01543685|P4|Participant Flow|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763079|NCT01545388|O3|Outcome|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
763080|NCT01545388|O2|Outcome|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
763081|NCT01545388|O1|Outcome|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
763082|NCT01545388|E3|Reported Event|Placebo|Participants received sitagliptin daily at pre-study dose, 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
763083|NCT01545388|E2|Reported Event|Metformin 250 mg b.i.d.|Participants received sitagliptin daily at pre-study dose, 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
763084|NCT01545388|E1|Reported Event|Metformin 500 mg q.d.|Participants received sitagliptin daily at pre-study dose, 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
763085|NCT01545336|B3|Baseline|Total|Total of all reporting groups
763086|NCT01545336|B2|Baseline|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
763087|NCT01545336|B1|Baseline|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
763088|NCT01545336|P2|Participant Flow|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
763089|NCT01545336|P1|Participant Flow|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
763090|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
763091|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
763092|NCT01545336|O2|Outcome|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
763093|NCT01545336|O1|Outcome|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
763094|NCT01545336|O2|Outcome|Placebo|"Placebo tablet by mouth once daily for 3 months~Placebo: 1 mg tablet to be taken 1 time daily"
763095|NCT01545336|O1|Outcome|Anastrozole|"1 mg tablet by mouth once daily for 3 months~Anastrozole: 1 mg tablet to be taken 1 time daily"
763096|NCT01545336|E2|Reported Event|Placebo|Placebo 1 mg tablet by mouth once daily for 3 months
763097|NCT01545336|E1|Reported Event|Anastrozole|Anastrozole 1 mg tablet by mouth once daily for 3 months
763098|NCT01545232|B3|Baseline|Total|Total of all reporting groups
763130|NCT01545193|B2|Baseline|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763099|NCT01545232|B2|Baseline|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763100|NCT01545232|B1|Baseline|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763101|NCT01545232|P2|Participant Flow|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763102|NCT01545232|P1|Participant Flow|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763103|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763104|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763105|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763106|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763107|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763594|NCT01543685|P3|Participant Flow|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763108|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763109|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763110|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763111|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763112|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763113|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763114|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763115|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763116|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763117|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763118|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763119|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763120|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763121|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763122|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763242|NCT01544582|B3|Baseline|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
777575|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
763123|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763124|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763125|NCT01545232|O2|Outcome|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763126|NCT01545232|O1|Outcome|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763127|NCT01545232|E2|Reported Event|1:1:2 Blood Transfusion Ratio|1:1:2 Blood Transfusion Ratio: Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
763128|NCT01545232|E1|Reported Event|1:1:1 Blood Transfusion Ratio|1:1:1 Blood Transfusion Ratio: Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
763131|NCT01545193|B1|Baseline|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763132|NCT01545193|P2|Participant Flow|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763133|NCT01545193|P1|Participant Flow|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763134|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763135|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763136|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763137|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763138|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763139|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763140|NCT01545193|O2|Outcome|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763141|NCT01545193|O1|Outcome|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763142|NCT01545193|E2|Reported Event|Age 70-90|"This is a older study cohort who is anticipated to have a higher incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763143|NCT01545193|E1|Reported Event|Age 18-50|"This is a younger study cohort who is anticipated to have a lower incidence of residual neuromuscular blockade~Age and incidence of residual neuromuscular blockade: An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade"
763144|NCT01544153|B5|Baseline|Total|Total of all reporting groups
763595|NCT01543685|P2|Participant Flow|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763145|NCT01544153|B4|Baseline|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763146|NCT01544153|B3|Baseline|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763147|NCT01544153|B2|Baseline|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
763148|NCT01544153|B1|Baseline|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
763149|NCT01544153|P4|Participant Flow|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763150|NCT01544153|P3|Participant Flow|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763151|NCT01544153|P2|Participant Flow|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
763315|NCT01544361|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
763152|NCT01544153|P1|Participant Flow|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
763153|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763154|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763155|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
763156|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
763157|NCT01544153|O4|Outcome|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763158|NCT01544153|O3|Outcome|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763159|NCT01544153|O2|Outcome|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
763160|NCT01544153|O1|Outcome|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
763161|NCT01544153|E4|Reported Event|WEB+SN+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763243|NCT01544582|B2|Baseline|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763162|NCT01544153|E3|Reported Event|WEB+NRT|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Nicotine Replacement Therapy (NRT): A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own."
763163|NCT01544153|E2|Reported Event|WEB+SN|"WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.~Social Network: Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
763164|NCT01544153|E1|Reported Event|WEB Only|"Control group receiving no additional intervention~WEB: Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website."
763165|NCT01544062|B3|Baseline|Total|Total of all reporting groups
763166|NCT01544062|B2|Baseline|Normal Saline|Study subjects receiving placebo
763167|NCT01544062|B1|Baseline|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763168|NCT01544062|P2|Participant Flow|Normal Saline|Study subjects receiving placebo
763169|NCT01544062|P1|Participant Flow|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763170|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763171|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763314|NCT01544361|P2|Participant Flow|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
763172|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763173|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763174|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763175|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763176|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763177|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763178|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763179|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763180|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763181|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763182|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763183|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763184|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763185|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763186|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763187|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763188|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763189|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763190|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763214|NCT01544023|B1|Baseline|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
763191|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763192|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763193|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763194|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763195|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763196|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763197|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763198|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763199|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763200|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763201|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
763202|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763203|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
763204|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
777576|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
763206|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763207|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
763208|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763209|NCT01544062|O1|Outcome|Normal Saline|Study subjects receiving placebo
763210|NCT01544062|O2|Outcome|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763211|NCT01544062|O1|Outcome|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763212|NCT01544062|E2|Reported Event|IV Acetaminophen|"Study subjects receiving IV acetaminophen~IV acetaminophen: Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763213|NCT01544062|E1|Reported Event|Normal Saline|"Study subjects receiving placebo~Placebo: Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours."
763309|NCT01544361|B2|Baseline|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
763215|NCT01544023|P1|Participant Flow|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
763216|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
763217|NCT01544023|O1|Outcome|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
763218|NCT01544023|E1|Reported Event|TiLOOP|"Patients with immediate or delayed-immediate heterologous BR who underwent skin-sparing (SSM) or nipple-sparing mastectomy (NSM) with silicone implants in combination with TiLOOP Bra (pfm medical, Cologne, Germany) were included."
763219|NCT01544998|B1|Baseline|Entire Study Population|Includes groups randomized to receive Tadalafil plus Nesiritide first, and Tadalafil plus Placebo first.
763220|NCT01544998|P2|Participant Flow|Tadalafil Plus Nesiritide, Then Tadalafil Plus Placebo|First intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
763221|NCT01544998|P1|Participant Flow|Tadalafil Plus Placebo, Then Tadalafil Plus Nesiritide|First intervention period: oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. There was a one week washout period. Second intervention period: oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting.
763222|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763223|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763224|NCT01544998|O2|Outcome|Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763244|NCT01544582|B1|Baseline|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763245|NCT01544582|P4|Participant Flow|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
777577|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
763225|NCT01544998|O1|Outcome|Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763226|NCT01544998|E4|Reported Event|PDD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763227|NCT01544998|E3|Reported Event|PDD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763228|NCT01544998|E2|Reported Event|PSD: Tadalafil Plus Placebo|Oral Tadalafil; after 1 hour, subcutaneous (sc) placebo given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763229|NCT01544998|E1|Reported Event|PSD: Tadalafil Plus Nesiritide|Oral Tadalafil; after 1 hour, sc Nesiritide given in the abdomen. After a lead in period of 15 min, a 30-min clearance was repeated, then acute saline load was given. During the 1 hour saline load, one 30-min clearance repeated with subject in supine position, then second 30-min clearance repeated with subject sitting. This dosing administration was in either first intervention period or second intervention period.
763230|NCT01544920|B3|Baseline|Total|Total of all reporting groups
763310|NCT01544361|B1|Baseline|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
763630|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763231|NCT01544920|B2|Baseline|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
763232|NCT01544920|B1|Baseline|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
763233|NCT01544920|P2|Participant Flow|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
763234|NCT01544920|P1|Participant Flow|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
763235|NCT01544920|O2|Outcome|Arm 2a: BOC + Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of BOC + peg-IFN + RBV for a total of 24 weeks of BOC (added at Week 4) + peg-IFN + RBV therapy.
763236|NCT01544920|O1|Outcome|Arm 1a: Peg-IFN + RBV 24 Weeks|Participants received an initial 4 week lead-in of peg-IFN + RBV. The subset of participants with undetectable HCV RNA at Week 4 received an additional 20 weeks of peg-IFN + RBV for a total of 24 weeks of peg-IFN + RBV therapy.
763237|NCT01544920|O2|Outcome|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
763238|NCT01544920|O1|Outcome|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
763239|NCT01544920|E2|Reported Event|Arm 2: BOC + Peg-IFN + RBV|Participants received an initial 4-week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, all participants had BOC added to the peg-IFN + RBV regimen at Week 6 regardless of HCV RNA levels. Participants who had undetectable HCV RNA at Week 4 continued on the BOC + peg-IFN + RBV regimen for an additional 20 weeks (total of 24 weeks of BOC + peg-IFN + RBV therapy) [Arm 2a]. Participants with detectable HCV RNA at Week 4 followed the RGT regimen for BOC + peg-IFN + RBV [Arm 2b].
763240|NCT01544920|E1|Reported Event|Arm 1: Peg-IFN + RBV|Participants received an initial 4 week lead-in of peg-IFN + RBV. Following HCV RNA analysis at Week 4, participants with undetectable HCV RNA received open label peg-IFN + RBV for an additional 18 weeks (total of 24 weeks of peg-IFN/RBV therapy) [Arm 1a]. Participants with detectable HCV RNA at Week 4 had BOC added to the peg-IFN + RBV regimen at Week 6 and then followed the Response Guided Therapy (RGT) regimen for BOC + peg-IFN + RBV [Arm 1b].
763241|NCT01544582|B4|Baseline|Total|Total of all reporting groups
763596|NCT01543685|P1|Participant Flow|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763246|NCT01544582|P3|Participant Flow|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763247|NCT01544582|P2|Participant Flow|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763248|NCT01544582|P1|Participant Flow|All Included Participants|All CHC genotype-1 participants included in study.
763249|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
763250|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763251|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763311|NCT01544361|P5|Participant Flow|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763312|NCT01544361|P4|Participant Flow|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763252|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763253|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763254|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763255|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763256|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763257|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763258|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763259|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
763260|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763295|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
763296|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763261|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763262|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763263|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
763313|NCT01544361|P3|Participant Flow|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763264|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763265|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763266|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763267|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
763268|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763269|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763270|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763271|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
763272|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763273|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763274|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763275|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
763276|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763277|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763278|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763279|NCT01544582|O4|Outcome|PR + Boceprevir + Telaprevir Group of Exposure|CHC genotype-1 participants included on study that received telaprevir + PR as routine clinical management and then switched to Boceprevir + PR treatment or vice-versa. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR + Boceprevir+Telaprevir Treatment Group of Exposure included 3 participants who were switched from telaprevir + PR to boceprevir + PR, 2 participants who switched from boceprevir + PR to telaprevir + PR, and one participant who switched from boceprevir + PR to telaprevir + PR, and then to boceprevir + PR during follow-up.
763280|NCT01544582|O3|Outcome|Telaprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received telaprevir + PR as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Telaprevir + PR Treatment Group of Exposure included 307 participants who received telaprevir + PR after the lead-in period to the end of follow-up.
763281|NCT01544582|O2|Outcome|Boceprevir + PR Group of Exposure|CHC genotype-1 participants included on study who received boceprevir + peginterferon and ribavirin (PR) as routine clinical management. For this analysis, participants were categorized by CHC treatment group of exposure. The Boceprevir + PR Treatment Group of Exposure included 298 participants who received boceprevir + PR after the lead-in period to the end of follow-up.
763282|NCT01544582|O1|Outcome|PR Group of Exposure|CHC genotype-1 participants included on study who received PR either alone or during the PR lead-in period when combined with boceprevir or telaprevir. For this analysis, participants were categorized by CHC treatment group of exposure, and could successively be assigned to different treatment groups of exposure depending on their treatment regimen (treatment group was not mutually exclusive). The PR Treatment Group of Exposure comprised all 74 participants receiving PR only, plus 292 participants from the Boceprevir + PR Treatment Group who received PR during the lead-in period, plus 28 participants from the Telaprevir + PR Treatment Group who received PR during the lead-in period.
763283|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
763284|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763285|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763286|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
763287|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763288|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763289|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
763290|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763291|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763292|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
763293|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763294|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763597|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763297|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763298|NCT01544582|O3|Outcome|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
763299|NCT01544582|O2|Outcome|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763300|NCT01544582|O1|Outcome|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763301|NCT01544582|O1|Outcome|All Included Participants|All CHC genotype-1 participants included in study.
763302|NCT01544582|E3|Reported Event|PR Alone|CHC genotype-1 participants included in study and prescribed PR alone as routine clinical management
763303|NCT01544582|E2|Reported Event|Telaprevir + PR|CHC genotype-1 participants included in study and prescribed telaprevir plus PR as routine clinical management.
763304|NCT01544582|E1|Reported Event|Boceprevir + PR|CHC genotype-1 participants included in study and prescribed boceprevir plus PR as routine clinical management.
763305|NCT01544361|B6|Baseline|TOTAL|Total of all reporting groups
763306|NCT01544361|B5|Baseline|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763307|NCT01544361|B4|Baseline|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763308|NCT01544361|B3|Baseline|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763316|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763317|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763318|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763319|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
763320|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
763321|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763322|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763323|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763324|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
763325|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
763326|NCT01544361|O5|Outcome|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763327|NCT01544361|O4|Outcome|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763328|NCT01544361|O3|Outcome|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763329|NCT01544361|O2|Outcome|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
763330|NCT01544361|O1|Outcome|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
763331|NCT01544361|E5|Reported Event|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763332|NCT01544361|E4|Reported Event|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763333|NCT01544361|E3|Reported Event|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
763334|NCT01544361|E2|Reported Event|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 milligram per kilogram (mg/kg) intravenous infusion over at least 60 minutes on Day 1.
763335|NCT01544361|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
763336|NCT01544348|B9|Baseline|Total|Total of all reporting groups
763337|NCT01544348|B8|Baseline|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
763338|NCT01544348|B7|Baseline|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
763339|NCT01544348|B6|Baseline|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
763340|NCT01544348|B5|Baseline|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
763341|NCT01544348|B4|Baseline|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
763342|NCT01544348|B3|Baseline|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
763343|NCT01544348|B2|Baseline|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
763344|NCT01544348|B1|Baseline|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
763345|NCT01544348|P8|Participant Flow|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
763346|NCT01544348|P7|Participant Flow|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
763347|NCT01544348|P6|Participant Flow|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
763348|NCT01544348|P5|Participant Flow|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
763349|NCT01544348|P4|Participant Flow|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
763350|NCT01544348|P3|Participant Flow|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
763351|NCT01544348|P2|Participant Flow|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
763352|NCT01544348|P1|Participant Flow|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
763353|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
763354|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
763355|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
763356|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
763357|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
763358|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
763359|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
763360|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
763361|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
763362|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
763363|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
763364|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
763365|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
763366|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
763367|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
763368|NCT01544348|O7|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
763369|NCT01544348|O6|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
763370|NCT01544348|O5|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
763371|NCT01544348|O4|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
763372|NCT01544348|O3|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
763373|NCT01544348|O2|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
763374|NCT01544348|O1|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
763375|NCT01544348|O8|Outcome|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
763376|NCT01544348|O7|Outcome|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
763377|NCT01544348|O6|Outcome|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
763378|NCT01544348|O5|Outcome|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
763379|NCT01544348|O4|Outcome|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
763380|NCT01544348|O3|Outcome|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
763381|NCT01544348|O2|Outcome|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
763382|NCT01544348|O1|Outcome|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
763383|NCT01544348|E8|Reported Event|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
763384|NCT01544348|E7|Reported Event|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
763385|NCT01544348|E6|Reported Event|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
763386|NCT01544348|E5|Reported Event|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
763387|NCT01544348|E4|Reported Event|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
763388|NCT01544348|E3|Reported Event|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
763389|NCT01544348|E2|Reported Event|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant’s Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
763390|NCT01544348|E1|Reported Event|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
763391|NCT01544309|B3|Baseline|Total|Total of all reporting groups
763392|NCT01544309|B2|Baseline|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763393|NCT01544309|B1|Baseline|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763394|NCT01544309|P2|Participant Flow|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)"
763395|NCT01544309|P1|Participant Flow|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in the Japan Atherosclerosis Society (JAS) Guidelines (GL) after 3 months, had the atorvastatin [ATV] dose of 20 mg.)"
763396|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763397|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763398|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763399|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763400|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763401|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763402|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763403|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763404|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763405|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763406|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763407|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763408|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763409|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763410|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763411|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763412|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763413|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763414|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763415|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763416|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763459|NCT01544179|E2|Reported Event|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763417|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763418|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763419|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763420|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763421|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763422|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763423|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763424|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763425|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763426|NCT01544309|O2|Outcome|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763427|NCT01544309|O1|Outcome|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763428|NCT01544309|E2|Reported Event|Rosuvastatin Administration Group|"Rosuvastatin: Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the RSV dose of 10 mg.)"
763429|NCT01544309|E1|Reported Event|Atorvastatin Administration Group|"Atorvastatin: Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.~(When not reach the LDL-C level of target in JAS GL after 3 months, had the ATV dose of 20 mg.)"
763430|NCT01544179|B3|Baseline|Total|Total of all reporting groups
763431|NCT01544179|B2|Baseline|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763432|NCT01544179|B1|Baseline|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763433|NCT01544179|P2|Participant Flow|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763434|NCT01544179|P1|Participant Flow|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763435|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763436|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763437|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763438|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763439|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763440|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763441|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763442|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763443|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763444|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763445|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763446|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763447|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763448|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763449|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763450|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763451|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763452|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763453|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763454|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763455|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763456|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763457|NCT01544179|O2|Outcome|Placebo|Placebo and cisplatin plus pemetrexed combination chemotherapy.
763458|NCT01544179|O1|Outcome|Gefitinib|Gefitinib 250mg and cisplatin plus pemetrexed combination chemotherapy
763461|NCT01544166|B1|Baseline|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763462|NCT01544166|P1|Participant Flow|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763463|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763464|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763465|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763466|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763467|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763468|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763469|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763470|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763471|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763472|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763473|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763474|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763475|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763476|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763477|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763478|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763479|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763480|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763481|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763482|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763483|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763484|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763485|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763486|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763487|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763488|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763489|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763490|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763491|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763492|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763493|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763494|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763495|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763496|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763497|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763498|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763499|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763500|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763501|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763502|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763503|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763504|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763505|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763506|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763598|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763507|NCT01544166|O1|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763508|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763509|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763510|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763511|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763512|NCT01544166|O2|Outcome|Combined MRI Assessment|Assessment was provided for the combined unenhanced and enhanced image set in all FAS subjects.
763513|NCT01544166|O1|Outcome|Unenhanced MRI Assessment|Assessment was provided for the unenhanced image set alone in all FAS subjects.
763514|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763515|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763516|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763517|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763518|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763519|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763520|NCT01544166|O1|Outcome|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763521|NCT01544166|E1|Reported Event|Overall Study|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
763522|NCT01543958|B1|Baseline|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763523|NCT01543958|P1|Participant Flow|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763524|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763525|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763526|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763527|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763528|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763529|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763530|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763531|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763532|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763533|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763534|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763535|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763536|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763537|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763538|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763539|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763540|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763541|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763542|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763543|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763544|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763545|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763546|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763547|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763548|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763549|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763550|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763551|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763552|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763553|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763554|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763555|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763556|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763557|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763558|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763559|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763560|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763561|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763562|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763563|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763564|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763565|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763566|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763567|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763568|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763569|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763570|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763571|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763572|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763573|NCT01543958|O1|Outcome|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763574|NCT01543958|E1|Reported Event|Sevelamer Carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
763575|NCT01543828|B3|Baseline|Total|Total of all reporting groups
763576|NCT01543828|B2|Baseline|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
763577|NCT01543828|B1|Baseline|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
763578|NCT01543828|P2|Participant Flow|Placebo Then Indacaterol|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
763579|NCT01543828|P1|Participant Flow|Indacaterol Then Placebo|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
763580|NCT01543828|O4|Outcome|placebo_treatment 2|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI) followed by treatment 2: placebo one dose via SDDPI between day 7 and 10. Albuterol was available for use as rescue medication.
763581|NCT01543828|O3|Outcome|placebo_treatment 1|In treatment 1, participants received placebo one dose delivered via SDDPI. Albuterol was available for use as rescue medication.
763582|NCT01543828|O2|Outcome|indacaterol_treatment 2|In treatment 1, participants received placebo one dose delivered via SDDPI followed by treatment 2: indacaterol 75 µg one dose delivered via SDDPI between Day 7 and Day 10. Albuterol was available for use as rescue medication.
763583|NCT01543828|O1|Outcome|indacaterol_treatment 1|In treatment 1: participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI). Albuterol was available for use as rescue medication.
763584|NCT01543828|E2|Reported Event|Placebo|Participants received placebo one dose delivered via SDDPI.
763585|NCT01543828|E1|Reported Event|Indacaterol|Participants received indacaterol 75 µg one dose delivered via single-dose dry-powder inhaler (SDDPI).
763586|NCT01543685|B6|Baseline|Total|Total of all reporting groups
763587|NCT01543685|B5|Baseline|Placebo|Placebo : Capsules
763588|NCT01543685|B4|Baseline|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763589|NCT01543685|B3|Baseline|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763590|NCT01543685|B2|Baseline|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763591|NCT01543685|B1|Baseline|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763592|NCT01543685|P5|Participant Flow|Placebo|Placebo : Capsules
763600|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763601|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763602|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763603|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763604|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763605|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763606|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763607|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763608|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763609|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763610|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763611|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763612|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763613|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763614|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763615|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763616|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763617|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763618|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763619|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763620|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763621|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763622|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763623|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763624|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763625|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763626|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763627|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763628|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763629|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763631|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763632|NCT01543685|O5|Outcome|Placebo|Placebo : Capsules
763633|NCT01543685|O4|Outcome|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763634|NCT01543685|O3|Outcome|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763635|NCT01543685|O2|Outcome|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763636|NCT01543685|O1|Outcome|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763637|NCT01543685|E5|Reported Event|Placebo|Placebo : Capsules
763638|NCT01543685|E4|Reported Event|Indomethacin 40 mg TID|Indomethacin : 40 mg TID capsules
763639|NCT01543685|E3|Reported Event|Indomethacin 40 mg BID|Indomethacin : 40 mg BID capsules
763640|NCT01543685|E2|Reported Event|Indomethacin 20 mg TID|Indomethacin : 20 mg TID capsules
763641|NCT01543685|E1|Reported Event|Celecoxib 200 mg|Celecoxib : 200 mg capsules
763642|NCT01543607|B1|Baseline|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
763643|NCT01543607|P1|Participant Flow|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
763644|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
763645|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
763646|NCT01543607|O1|Outcome|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
763647|NCT01543607|E1|Reported Event|Treatment|"Radiofrequency ablation catheter~Radiofrequency ablation catheter (Habib EndoHBP): Catheter placement into bile duct"
763648|NCT01543581|B1|Baseline|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
763649|NCT01543581|P2|Participant Flow|Inactive Placebo|Those to whom the inactive placebo is given.
763650|NCT01543581|P1|Participant Flow|Vismodegib|Those to whom the drug is given.
763651|NCT01543581|O1|Outcome|Vismodegib|Those to whom the drug is given.
763652|NCT01543581|O1|Outcome|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
763653|NCT01543581|E2|Reported Event|Inactive Placebo|Those to whom the inactive placebo is given.
763654|NCT01543581|E1|Reported Event|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
763655|NCT01543568|B1|Baseline|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763656|NCT01543568|P1|Participant Flow|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763657|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763658|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763659|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763660|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763661|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763662|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763663|NCT01543568|O1|Outcome|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763664|NCT01543568|E1|Reported Event|2.0 mg Intravitreal Aflibercept|"open label, Subjects seen monthly & given mandatory 2.0 mg aflibercept at baseline, months 1, 2 and 4. Pro re nata (PRN) retreatment at months 3 and 5 was performed upon evidence of disease on spectral domain-optical coherence tomography (SD-OCT)~aflibercept 2.0 mg: Intravitreal aflibercept injection 2.0 mg"
763665|NCT01543503|B3|Baseline|Total|Total of all reporting groups
763666|NCT01543503|B2|Baseline|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763937|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763667|NCT01543503|B1|Baseline|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763668|NCT01543503|P2|Participant Flow|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763669|NCT01543503|P1|Participant Flow|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to conventional synthetic disease-modifying anti-rheumatic drug (csDMARD) therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763670|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763671|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763672|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763673|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763714|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763715|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
764874|NCT01536886|B4|Baseline|Ointment Vehicle|Ointment with no active ingredients
763674|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763675|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763676|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763677|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763678|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763679|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763680|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763681|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763682|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763683|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763684|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763685|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763686|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
777578|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
763687|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763688|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763689|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763690|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763691|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763692|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763693|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763694|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763695|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763696|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763697|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763698|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763699|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
777579|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
763700|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763701|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763702|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763703|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763704|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763705|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763706|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763707|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763708|NCT01543503|O2|Outcome|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763709|NCT01543503|O1|Outcome|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763710|NCT01543503|E2|Reported Event|TNF Inhibitor|Participants with rheumatoid arthritis who were currently being treated with a TNF inhibitor as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. The TNF inhibitor administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed TNF inhibitor for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763711|NCT01543503|E1|Reported Event|Tocilizumab|Participants with rheumatoid arthritis who were currently being treated with tocilizumab as a first biologic therapy and were non-responders or intolerant to csDMARD therapy. Tocilizumab administration occurred as per routine practice and following the local prescribing information. Participants were observed for 52 weeks after initiation of the first biologic therapy. Participants who stopped treatment with the prescribed tocilizumab for reasons of inefficacy or intolerance continued to be observed for the planned period of 52 weeks.
763712|NCT01543204|B1|Baseline|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763713|NCT01543204|P1|Participant Flow|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763857|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763716|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763717|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763718|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763719|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763720|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763721|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763722|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763723|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763724|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763725|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763726|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763727|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763938|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763728|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763729|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
763730|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763731|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763732|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
763733|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763734|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763735|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
763736|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763737|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763738|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
763739|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763740|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763741|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
763742|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763743|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763744|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763745|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763746|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
764157|NCT01540825|B9|Baseline|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
763747|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks..
763748|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763749|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763750|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763751|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763752|NCT01543204|O2|Outcome|Anti-adalimumab Antibody Negative|Participants who were anti-adalimumab antibody negative at screening received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763753|NCT01543204|O1|Outcome|Anti-adalimumab Antibody Positive|Participants who were anti-adalimumab antibody positive at screening received etanercept 50 mg, BIW, subcutaneously for 12 weeks followed by 50 mg, QW for an additional 12 weeks.
763754|NCT01543204|O1|Outcome|Etanercept 50 mg|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763755|NCT01543204|E1|Reported Event|Etanercept 50mg BIW/50mg QW|Participants received etanercept 50 mg, twice weekly (BIW), subcutaneously (SC) for 12 weeks followed by 50 mg, once weekly (QW), SC for an additional 12 weeks.
763756|NCT01543178|B4|Baseline|Total|Total of all reporting groups
763757|NCT01543178|B3|Baseline|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.
763939|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763758|NCT01543178|B2|Baseline|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.
763759|NCT01543178|B1|Baseline|Open-label Rifaximin Only|The 1943 subjects in this group did not continue into the double-blind period of the study. Open-label treatment was rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up.
763760|NCT01543178|P3|Participant Flow|Double-blind Placebo (Retreatment)|The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
763761|NCT01543178|P2|Participant Flow|Double-blind Rifaximin (Retreatment)|The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period. For participant flow during the open-label period, these subjects are included in the 2583 subjects in the open-label rifaximin group.
763762|NCT01543178|P1|Participant Flow|Open-label Rifaximin|"Subjects received open-label rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up. Responders continued into Maintenance Phase 1 (treatment free). Nonresponders withdrew from the study.~Of the 2583 subjects in this group, 636 eventually met criteria for recurrence in Maintenance Phase 1, entered the double-blind period, and were randomized 1:1 to receive rifaximin 550 mg or placebo."
763763|NCT01543178|O2|Outcome|Double-blind Placebo (Retreatment)|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo."
763764|NCT01543178|O1|Outcome|Double-blind Rifaximin (Retreatment)|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin."
763765|NCT01543178|E3|Reported Event|Double-blind Retreatment Experience - Placebo Group|"The 308 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the placebo group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received placebo TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with placebo.~Double-blind experience is shown here."
763766|NCT01543178|E2|Reported Event|Double-blind Retreatment Experience - Rifaximin Group|"The 328 subjects in this group received rifaximin in the open-label period, eventually met criteria for recurrence and were randomized to the rifaximin group for the double-blind retreatment period.~During the double-blind period, subjects in this arm received rifaximin 550 mg TID for 2 weeks with a 4-week treatment-free follow-up (first retreatment) followed by Maintenance Phase 2 (6 weeks [treatment free]) followed by a second retreatment with rifaximin.~Double-blind experience is shown here."
763767|NCT01543178|E1|Reported Event|Total Open-label Experience|"This group includes all 2579 subjects who received rifaximin the open-label period.~Open-label experience is shown here."
763768|NCT01543074|B5|Baseline|Total|Total of all reporting groups
763769|NCT01543074|B4|Baseline|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763770|NCT01543074|B3|Baseline|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
763771|NCT01543074|B2|Baseline|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763772|NCT01543074|B1|Baseline|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
763773|NCT01543074|P4|Participant Flow|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763774|NCT01543074|P3|Participant Flow|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
763775|NCT01543074|P2|Participant Flow|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763776|NCT01543074|P1|Participant Flow|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
763777|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~Garlic oil: 1 pill = 30 mg garlic oil/day~BSE: 2 pills = 200 micromoles of Sulforaphane/day"
763778|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~BSE: 2 pills = 200 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
763779|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic oil: 1 pill = 30 mg garlic oil/day"
763780|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo: 2 pills = 0 micromoles of Sulforaphane/day~Garlic Oil Placebo: 1 pill = 0 mg garlic oil/day"
763781|NCT01543074|O4|Outcome|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763940|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763782|NCT01543074|O3|Outcome|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
763783|NCT01543074|O2|Outcome|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763784|NCT01543074|O1|Outcome|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
763785|NCT01543074|E4|Reported Event|BSE & Garlic Oil|"two BSE and one garlic oil capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763786|NCT01543074|E3|Reported Event|BSE Plus Garlic Oil Placebo|"two BSE capsules plus one garlic oil placebo capsule per day for seven days~garlic oil plus BSE placebo: see arm description~BSE & Garlic Oil: see arm description"
763787|NCT01543074|E2|Reported Event|Garlic Oil Plus BSE Placebo|"one garlic oil capsule plus 2 BSE placebo capsules per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE plus garlic oil placebo: see arm description"
763788|NCT01543074|E1|Reported Event|BSE Placebo & Garlic Oil Placebo|"Two BSE placebo capsules and one garlic oil placebo capsule per day for seven days~BSE placebo & garlic oil placebo: see arm description~BSE & Garlic Oil: see arm description"
763789|NCT01542957|B3|Baseline|Total|Total of all reporting groups
763790|NCT01542957|B2|Baseline|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
763791|NCT01542957|B1|Baseline|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
763792|NCT01542957|P2|Participant Flow|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
763793|NCT01542957|P1|Participant Flow|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
763794|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
763795|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
763796|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
763797|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
763798|NCT01542957|O2|Outcome|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
764158|NCT01540825|B8|Baseline|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
763799|NCT01542957|O1|Outcome|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
763800|NCT01542957|E2|Reported Event|Cognitive Behavioral Therapy|"Combined Group and Individual Cognitive Behavioral Therapy~Cognitive Behavioral Therapy for Depression: Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized."
763801|NCT01542957|E1|Reported Event|Cognitive Behavioral + Dilemma Therapy|"Combines Group Cognitive Behavioral Therapy with a Individual Dilemma-Focused Intervention~Combined Cognitive Behavioral and Dilemma-Focused Therapy: 7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized."
763802|NCT01542788|B3|Baseline|Total|Total of all reporting groups
763803|NCT01542788|B2|Baseline|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763804|NCT01542788|B1|Baseline|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763805|NCT01542788|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763806|NCT01542788|P1|Participant Flow|SOF+RBV|Participants were randomized to receive sofosbuvir (SOF)+ribavirin (RBV) for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
764095|NCT01541397|E1|Reported Event|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
763807|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763808|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763809|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763810|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763811|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763812|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763813|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763814|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763815|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763816|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763817|NCT01542788|O2|Outcome|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763818|NCT01542788|O1|Outcome|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763819|NCT01542788|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match SOF plus placebo to match RBV for 12 weeks. Placebos were administered in the same manner as their active counterparts.
763820|NCT01542788|E1|Reported Event|SOF+RBV|Participants were randomized to receive SOF+RBV for 12 weeks. SOF was administered as a 400 mg tablet orally once daily. RBV was administered as 200 mg tablets (1000-1200 mg daily based on weight) according to package insert recommendations.
763821|NCT01542684|B1|Baseline|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
763822|NCT01542684|P1|Participant Flow|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~Granulocyte-macrophage colony-stimulating factor (GM-CSF) administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
763823|NCT01542684|O1|Outcome|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle will last at least 4 weeks~Azacytidine: Starting dose: 40 mg/m^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days.~GM-CSF: 250 mcg/m^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days."
763858|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763824|NCT01542684|E1|Reported Event|Azacytidine + GM-CSF|"Azacytidine administered intravenously (IV) or subcutaneously (SQ) at starting dose of 40 mg/m^2, daily for 4 days.~GM-CSF administered IV or subcutaneously at 250 mcg/m^2 one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.~Each treatment cycle lasts at least 4 weeks."
763825|NCT01542645|B3|Baseline|Total|Total of all reporting groups
763826|NCT01542645|B2|Baseline|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763827|NCT01542645|B1|Baseline|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763828|NCT01542645|P2|Participant Flow|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763829|NCT01542645|P1|Participant Flow|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763830|NCT01542645|O2|Outcome|Fentanyl|
763831|NCT01542645|O1|Outcome|Methadone|
763832|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763833|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
764177|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
763834|NCT01542645|O2|Outcome|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763835|NCT01542645|O1|Outcome|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763836|NCT01542645|E2|Reported Event|Fentanyl|Fentanyl: Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763837|NCT01542645|E1|Reported Event|Methadone|Methadone: Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
763838|NCT01542632|B7|Baseline|Total|Total of all reporting groups
763839|NCT01542632|B6|Baseline|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763840|NCT01542632|B5|Baseline|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763841|NCT01542632|B4|Baseline|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763842|NCT01542632|B3|Baseline|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
763843|NCT01542632|B2|Baseline|Group 2 (DO:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763844|NCT01542632|B1|Baseline|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763845|NCT01542632|P6|Participant Flow|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763846|NCT01542632|P5|Participant Flow|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763847|NCT01542632|P4|Participant Flow|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation(TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763848|NCT01542632|P3|Participant Flow|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
763849|NCT01542632|P2|Participant Flow|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763850|NCT01542632|P1|Participant Flow|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763851|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763852|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763853|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763854|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
763855|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763856|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763859|NCT01542632|O4|Outcome|Group 4 (D0:TDV,P D90:TDV,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763860|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
763861|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763862|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763863|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763864|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763865|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763866|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
763867|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
814921|NCT01344460|O2|Outcome|Unenhanced MRA|
763868|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763869|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763870|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763871|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763872|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
763873|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763874|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763875|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763876|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763877|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763878|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
763879|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763880|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takedas Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763881|NCT01542632|O6|Outcome|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 1 and 90.
763882|NCT01542632|O5|Outcome|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763883|NCT01542632|O4|Outcome|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763884|NCT01542632|O3|Outcome|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 1. TDV, 0.5 mL, subcutaneous injection on Day 90.
763885|NCT01542632|O2|Outcome|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763886|NCT01542632|O1|Outcome|Group 1 (D0:TDV,P D90:TDV)|Takeda’s Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763887|NCT01542632|E6|Reported Event|Group 6 (D0:1/10TDV D90:1/10TDV)|1/10 TDV, 0.5 mL, subcutaneous injection on Days 0 and 90.
763888|NCT01542632|E5|Reported Event|Group 5 (D0:TDVN,TDVN D90:TDVN,TDVN)|TDV new formulation, 0.5 mL, subcutaneous injection in one arm and TDV new formulation, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763889|NCT01542632|E4|Reported Event|Group 4 (D0:TDVN,P D90:TDVN,P)|TDV new formulation (TDVN), 0.5 mL, subcutaneous injection in one arm and TDV new formulation placebo, 0.5 mL, subcutaneous injection in the other arm on Days 0 and 90.
763890|NCT01542632|E3|Reported Event|Group 3 (D0:TDV,TDV D90:TDV)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV, 0.5 mL, subcutaneous injection on Day 90.
764875|NCT01536886|B3|Baseline|LEO 90100 Vehicle|Aerosol foam with no active ingredients
763891|NCT01542632|E2|Reported Event|Group 2 (D0:TDV,TDV D90:P)|TDV, 0.5 mL, subcutaneous injection in one arm and TDV, 0.5 mL, subcutaneous injection in the other arm on Day 0. TDV placebo, 0.5 mL, subcutaneous injection on Day 90.
763892|NCT01542632|E1|Reported Event|Group 1 (D0:TDV,P D90:TDV)|Takeda's Tetravalent Dengue Vaccine Candidate (TDV), 0.5 mL, subcutaneous injection in one arm and TDV placebo (P), 0.5 mL, subcutaneous injection in the other arm on Day 0 (D0). TDV, 0.5 mL, subcutaneous injection on Day 90 (D90).
763893|NCT01542541|B3|Baseline|Total|Total of all reporting groups
763894|NCT01542541|B2|Baseline|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
763895|NCT01542541|B1|Baseline|Rifaximin|Rifaximin: 550mg BID for 2 days
763896|NCT01542541|P2|Participant Flow|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
763897|NCT01542541|P1|Participant Flow|Rifaximin|Rifaximin: 550mg BID for 2 days
763898|NCT01542541|O2|Outcome|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
763899|NCT01542541|O1|Outcome|Rifaximin|Rifaximin: 550mg BID for 2 days
763900|NCT01542541|E2|Reported Event|Control|Randomly-selected matched PET-CT scans performed on same day as intervention group.
763901|NCT01542541|E1|Reported Event|Rifaximin|Rifaximin: 550mg BID for 2 days
763902|NCT01542502|B1|Baseline|All Participants|Baseline measures for all study participants
763903|NCT01542502|P2|Participant Flow|Placebo (First) Then Anakinra (Second)|"Treatment with daily subcutaneous injections of Placebo for 14 days, followed by daily subcutaneous injections of Anakinra for 14 days~Placebo: Placebo daily subcutaneous injection Anakinra: Anakinra 100 mg daily subcutaneous injection"
814922|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
763904|NCT01542502|P1|Participant Flow|Anakinra (First) Then Placebo (Second)|"Treatment with daily subcutaneous injections of Anakinra 100 mg for 14 days, followed by daily subcutaneous injections of Placebo for 14 days~Anakinra: Anakinra 100 mg daily subcutaneous injection Placebo: Placebo daily subcutaneous injection"
763905|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
763906|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra~Anakinra: Anakinra 100 mg daily subcutaneous injection"
763907|NCT01542502|O2|Outcome|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
763908|NCT01542502|O1|Outcome|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
763909|NCT01542502|E2|Reported Event|Placebo|"Treatment with daily subcutaneous injection of placebo~Placebo: Placebo daily subcutaneous injection"
763910|NCT01542502|E1|Reported Event|Anakinra|"Treatment with daily subcutaneous injections of Anakinra 100 mg~Anakinra: Anakinra 100 mg daily subcutaneous injection"
763911|NCT01542372|B1|Baseline|Step I: SSRI/SSRN Treatment of PTSD|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763912|NCT01542372|P2|Participant Flow|CBT Augmentation|"In this arm, patients were given CBT to treat SSRI/SSRN-resistant PTSD.~Cognitive Behavioral Therapy for PTSD: This is a culturally sensitive CBT for the treatment of PTSD"
763913|NCT01542372|P1|Participant Flow|Medication Augmentation (Prazosin)|"In this arm, the patients were given a medication augmentation for SSRI/SSRN-resistant PTSD, with the preferred first-line agent being prazosin.~Prazosin as first-line agent: Prazosin .5 to 2 mg"
763914|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763915|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763916|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763917|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763918|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763919|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763920|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763921|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763922|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763923|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763924|NCT01542372|O2|Outcome|CBT Augmentation|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763962|NCT01542034|B2|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763925|NCT01542372|O1|Outcome|Medication Augmentation (Prazosin)|At Step I, patients receive an SSRI or SSRN to treat PTSD. If a treatment course of SSRI/SSRN does not reduce PTSD to indicated levels, then the patient enters Step 2, which has two arms: Medication or CBT augmentation
763926|NCT01542372|E1|Reported Event|Step I and Step 2|Step 1 is treatment with SSRI or SSRN. Step 2 is Medication or CBT augmentation.
763927|NCT01542307|B1|Baseline|Enrolled Subjects|Oxygen or Medical Air is inhaled in random order for 30 minutes during each migraine attack (total 4 attacks)
763928|NCT01542307|P2|Participant Flow|Medical Air-treated Migraine Attacks|Medical air is inhaled for 30 minutes during a migraine attack
763929|NCT01542307|P1|Participant Flow|Oxygen-treated Migraine Attacks|Oxygen is inhaled for 30 minutes during a migraine attack
763930|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763931|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763932|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763933|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763934|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763935|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763936|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
764320|NCT01540370|P1|Participant Flow|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
763941|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763942|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763943|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763944|NCT01542307|O2|Outcome|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763945|NCT01542307|O1|Outcome|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763946|NCT01542307|E2|Reported Event|Room Air|"Medical air inhaled for 30 minutes during migraine attack~Room air: Placebo"
763947|NCT01542307|E1|Reported Event|Oxygen|"Oxygen is inhaled for 30 minutes during migraine attack~Oxygen: Oxygen is inhaled for 30 minutes during migraine attack"
763948|NCT01542255|B1|Baseline|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
763949|NCT01542255|P1|Participant Flow|Combined Low Dose Treatment|"A cycle of therapy is 3 weeks of continuous dosing with a 1 week rest.~Schema of treatment is:~1 mg/m2 vinblastine three times a week iv 60 mg/m2 cyclophosphamide by mouth 15 mg/m2 dacarbazine three times a week iv~vinblastine: 1 mg/m2 vinblastine given three times per week administered intravenously.~Cyclophosphamide: 60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest~dacarbazine: 15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest"
763950|NCT01542255|O1|Outcome|Single Arm|
763951|NCT01542255|E1|Reported Event|Single Arm|all patients received cyclophosphamide, DTIC and vinblastine
763952|NCT01542125|B3|Baseline|Total|Total of all reporting groups
763953|NCT01542125|B2|Baseline|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
763954|NCT01542125|B1|Baseline|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
763955|NCT01542125|P2|Participant Flow|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
763956|NCT01542125|P1|Participant Flow|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
763957|NCT01542125|O2|Outcome|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
763958|NCT01542125|O1|Outcome|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
763959|NCT01542125|E2|Reported Event|Placebo Group|"This group received a placebo that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing.~Placebo: Tubes were visually identical to the Liposomal Lidocaine tubes."
763960|NCT01542125|E1|Reported Event|Liposomal Lidocaine Group|"Patients in this groups received 4% Liposomal Lidocaine that was applied to the area immediately surrounding the pin site(s) and was covered with an opaque Tegaderm dressing~Liposomal Lidocaine: 4% Liposomal Lidocaine"
763961|NCT01542034|B3|Baseline|Total|Total of all reporting groups
764159|NCT01540825|B7|Baseline|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
763963|NCT01542034|B1|Baseline|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763964|NCT01542034|P2|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763965|NCT01542034|P1|Participant Flow|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763966|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763967|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763968|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763969|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763970|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763971|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763972|NCT01542034|O2|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
764321|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
763973|NCT01542034|O1|Outcome|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763974|NCT01542034|E2|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763975|NCT01542034|E1|Reported Event|Deoxycholic Acid Injection|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
763976|NCT01541969|B3|Baseline|Total|Total of all reporting groups
763977|NCT01541969|B2|Baseline|Tinnitus Masking|see Protocol section for details
763978|NCT01541969|B1|Baseline|CR Neuromodulation|see Protocol section for details
763979|NCT01541969|P2|Participant Flow|Tinnitus Masking|"The active control group had the same ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-36 weeks).~The active comparator group received the intervention in a double-blind RCT (0-12 weeks). They received the same device as the treatment group but the sound stimulation was determined according to an algorithm predicted not to break up tinnitus generating activity in the brain. The device may have a tinnitus masking effect in the active comparator group.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they received the verum experimental intervention."
763980|NCT01541969|P1|Participant Flow|CR Neuromodulation|"Acoustic Co-ordinated Reset (CR) Neuromodulation includes an ear level device which delivers patterned sound stimulation. Participants were asked to wear the device for 4-6 hours per day (0-12 weeks) and for at least 4 hours daily (12-36 weeks)~The experimental arm received the intervention in a double-blind RCT (0-12 weeks), with the device fitted according to audiologist training given by the manufacturer/funder. An individually specified sound stimulation algorithm is hypothesised to interrupt tinnitus generating activity in the brain.~After the first 12 weeks, the participants entered into the open-label extension (unblinded, 12-36 weeks) in which they continued with the same experimental intervention."
763981|NCT01541969|O2|Outcome|Tinnitus Masking|The active comparator group were unblinded at 12 weeks and the device algorithm was reprogrammed in the same way as the experimental intervention. At 36 weeks, this group had therefore received a mixture of placebo (0-12 weeks) and active treatment (12-36 weeks).
763982|NCT01541969|O1|Outcome|CR Neuromodulation|The treatment group were unblinded at 12 weeks and then continued to receive the same experimental intervention. At 36 weeks, this group had therefore received active treatment (0-36 weeks).
763983|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
763984|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
763985|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
763986|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
763987|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
763988|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
763989|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details.
763990|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
763991|NCT01541969|O2|Outcome|Tinnitus Masking|see Protocol section for details
763992|NCT01541969|O1|Outcome|CR Neuromodulation|see Protocol section for details
763993|NCT01541969|E2|Reported Event|Tinnitus Masking|see Protocol section for details
763994|NCT01541969|E1|Reported Event|Acoustic CR Neuromodulation|see Protocol section for details
763995|NCT01541930|B1|Baseline|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
763996|NCT01541930|P1|Participant Flow|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
763997|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Pain evaluation on Day 14 by Visual Analogue Scale (mm) One patient was withdrawn on Day 7 by Subject's request
763998|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Pain evaluation on Day 7 by Visual Analogue Scale (mm)
763999|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Pain evaluation on Day 0 (baseline) by Visual Analogue Scale (mm)
764000|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Appearance score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
764001|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Appearance score evaluated on Day 7
764002|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Appearance score evaluated on Day 0 (baseline)
764003|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
764004|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
764005|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
764006|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 by Subject's request.
764007|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
764008|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (baseline)
764009|NCT01541930|O3|Outcome|GK567, Day 14|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
764010|NCT01541930|O2|Outcome|GK567, Day 7|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
764011|NCT01541930|O1|Outcome|GK567, Day 0|Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 0 (Baseline)
764012|NCT01541930|O1|Outcome|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
764013|NCT01541930|E1|Reported Event|GK567|Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g
764014|NCT01541917|B4|Baseline|Total|Total of all reporting groups
764015|NCT01541917|B3|Baseline|Never Randomized|This group comprises participants that consented but were never randomized to a condition due to being determined to not meet eligibility criteria or self-withdrawing before randomization.
764178|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764016|NCT01541917|B2|Baseline|Online Disease Education Control|The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual health coach to discuss the participant's efforts at managing his/her disease.
764017|NCT01541917|B1|Baseline|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach to review material and help enhance motivation.
764018|NCT01541917|P2|Participant Flow|Online Disease Education Control|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.~Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764019|NCT01541917|P1|Participant Flow|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.~Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
764020|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764021|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
764022|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764023|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
764024|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764046|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764025|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
764026|NCT01541917|O2|Outcome|Online Disease Education|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764027|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
764028|NCT01541917|O2|Outcome|Online Disease Education|"Involves viewing 12 educational websites about Juvenile Idiopathic Arthritis over the course of 12 weeks.~Online disease education: The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764096|NCT01541371|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
764029|NCT01541917|O1|Outcome|Web-based Coping Skills Training|"Involves completion of a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support.~Web-based coping skills training: This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation."
764030|NCT01541917|O2|Outcome|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764031|NCT01541917|O1|Outcome|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
764032|NCT01541917|E2|Reported Event|Online Disease Education Control|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse “health coach to discuss the participant's efforts at managing his/her disease."
764033|NCT01541917|E1|Reported Event|Web-based Coping Skills Training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
764034|NCT01541865|B1|Baseline|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764035|NCT01541865|P1|Participant Flow|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764036|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764037|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764038|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764039|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764040|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764041|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764042|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764043|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764044|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764045|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
777580|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
764047|NCT01541865|O1|Outcome|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764048|NCT01541865|E1|Reported Event|Renal Denervation|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the Vessix Renal Denervation System.
764049|NCT01541735|B3|Baseline|Total|Total of all reporting groups
764050|NCT01541735|B2|Baseline|Placebo|Placebo of calcined magnesia, capsules
764051|NCT01541735|B1|Baseline|Pantoprazole|The pantoprazole will be administered in 40mg capsules
764052|NCT01541735|P2|Participant Flow|Placebo|Placebo of calcined magnesia, capsules PO, 30 minutes before to breakfast during 45 days
764053|NCT01541735|P1|Participant Flow|Pantoprazole|The pantoprazole will be administered in 40mg capsules PO, 30 minutes before to breakfast during 45 days
764054|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
764055|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
764056|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
764057|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
764058|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
764059|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
764060|NCT01541735|O2|Outcome|Placebo|Placebo of calcined magnesia, capsules
764061|NCT01541735|O1|Outcome|Pantoprazole|The pantoprazole will be administered in 40mg capsules
764062|NCT01541735|E2|Reported Event|Placebo|Placebo of calcined magnesia, capsules
764063|NCT01541735|E1|Reported Event|Pantoprazole|The pantoprazole will be administered in 40mg capsules
764064|NCT01541644|B1|Baseline|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
764065|NCT01541644|P1|Participant Flow|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
764066|NCT01541644|O1|Outcome|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
764067|NCT01541644|E1|Reported Event|Acupuncture|"All participants will receive acupuncture treatments over a total of 10 weeks.~Acupuncture: Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks."
764068|NCT01541553|B3|Baseline|Total|Total of all reporting groups
764069|NCT01541553|B2|Baseline|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
764070|NCT01541553|B1|Baseline|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
764071|NCT01541553|P2|Participant Flow|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
764072|NCT01541553|P1|Participant Flow|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
764073|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
764074|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
764075|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
764076|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
764077|NCT01541553|O2|Outcome|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
764078|NCT01541553|O1|Outcome|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
764079|NCT01541553|E2|Reported Event|Vehicle Gel|"Cryotherapy followed by vehicle gel~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with vehicle gel once daily for 3 consecutive days."
764080|NCT01541553|E1|Reported Event|PEP005 Gel, 0.015%|"Cryotherapy followed by PEP005 Gel, 0.015%~Cryotherapy of all visible AKs (4-8 lesions, “baseline AKs”) in the selected treatment area, 2-4 weeks healing time followed by field treatment with PEP005 gel, 0.015% once daily for 3 consecutive days"
764081|NCT01541397|B3|Baseline|Total|Total of all reporting groups
764082|NCT01541397|B2|Baseline|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
764083|NCT01541397|B1|Baseline|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
764155|NCT01540825|B11|Baseline|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764084|NCT01541397|P2|Participant Flow|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
764085|NCT01541397|P1|Participant Flow|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
764086|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
764087|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
764088|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
764089|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
764090|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
764091|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
764092|NCT01541397|O2|Outcome|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
764093|NCT01541397|O1|Outcome|Non-Kuvan Treated|Adults with hyperphenylalaninemia who have are not receiving Kuvan therapy.
764094|NCT01541397|E2|Reported Event|Kuvan Treated|"Adults with hyperphenylalaninemia who are treated with Kuvan (sapropterin).~Sapropterin: 20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy"
764097|NCT01541371|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator’s discretion once daily for 12 weeks.
764098|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
764099|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
764100|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
764101|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
764102|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
764103|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
764104|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
764105|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
764106|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
764107|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
764108|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
764156|NCT01540825|B10|Baseline|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
777581|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
764109|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
764110|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
764111|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
764112|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
764113|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
764114|NCT01541371|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
764175|NCT01540825|P2|Participant Flow|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764115|NCT01541371|O3|Outcome|Other Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics due to other reasons.
764116|NCT01541371|O2|Outcome|Lack of Tolerability Group|Paliperidone ER tablet in flexible dose of 3, 6, 9 or 12 mg as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (defined as the presence of clinically relevant side effects with the previous antipsychotic medication).
764117|NCT01541371|O1|Outcome|Lack of Efficacy Group|Paliperidone extended release (ER) tablet in flexible dose of 3, 6, 9 or 12 milligram (mg) as per Investigator’s discretion was given once daily orally for 12 weeks to participants who transitioned to paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (defined as participants with a baseline total Positive and Negative Syndrome Scale [PANSS] score more than [>] or equal to [=] 70 or >=2 items scoring >=4 in the Positive or Negative Symptom Subscale or >=3 items scoring >=4 in the General Psychopathology Subscale).
764118|NCT01541371|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on Investigator’s discretion once daily for 12 weeks.
764119|NCT01541358|B1|Baseline|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|
764120|NCT01541358|P1|Participant Flow|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
764121|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
764122|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and undergo a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
764123|NCT01541358|O1|Outcome|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients were injected with approximately 5mCi F18 NaF and underwent a PET/CT scan approximately 60 minutes later.~A whole body non-contrast CT was obtained for attenuation correction and anatomic localization of radiotracer activity. Positron emission tomographic scans were obtained over the same anatomical regions as the CT scan. Images were reconstructed and reviewed in the axial, coronal, and sagittal planes."
764124|NCT01541358|E1|Reported Event|Diagnostic (Fluorine F 18 Sodium Fluoride PET/CT)|"Patients undergo fluorine F 18 sodium fluoride PET/CT scan.~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET/CT scan~positron emission tomography/computed tomography: Undergo fluorine F 18 sodium fluoride PET/CT scan"
764125|NCT01541254|B1|Baseline|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
764126|NCT01541254|P1|Participant Flow|Single Arm|"Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)~Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.): Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)"
764127|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
764128|NCT01541254|O1|Outcome|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
764129|NCT01541254|E1|Reported Event|Single Arm|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
764130|NCT01540981|B3|Baseline|Total|Total of all reporting groups
764131|NCT01540981|B2|Baseline|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
777582|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
764132|NCT01540981|B1|Baseline|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
764133|NCT01540981|P2|Participant Flow|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
764134|NCT01540981|P1|Participant Flow|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
764135|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
764136|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
764137|NCT01540981|O2|Outcome|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
764138|NCT01540981|O1|Outcome|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
764176|NCT01540825|P1|Participant Flow|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
764139|NCT01540981|E2|Reported Event|MIST Therapy With SOC|"Standard of Care including pressure relief, wound cleansing, creams, and dressings as needed plus MIST Therapy daily for 5 days and then every other day for up to 7 more days~MIST Therapy: FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area."
764140|NCT01540981|E1|Reported Event|SOC - Standard of Care|"Standard of care consists of pressure relief, creams, wound cleansing and dressings as needed~Standard of Care: Standard of Care consists of pressure relief, wound cleansing and dressing as needed"
764141|NCT01540851|B3|Baseline|Total|Total of all reporting groups
764142|NCT01540851|B2|Baseline|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764143|NCT01540851|B1|Baseline|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764144|NCT01540851|P2|Participant Flow|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764145|NCT01540851|P1|Participant Flow|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764146|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
764147|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
764148|NCT01540851|O2|Outcome|Usual Care Group|Subjects in the Usual Care group receive the current standard post-operative TKA care
764149|NCT01540851|O1|Outcome|Care Navigator Intervention Group|Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively
764150|NCT01540851|O2|Outcome|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764151|NCT01540851|O1|Outcome|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764152|NCT01540851|E2|Reported Event|Usual Care Group|"Subjects in the Usual Care group receive the current standard post-operative TKA care~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764153|NCT01540851|E1|Reported Event|Care Navigator Intervention Group|"Subjects randomized to the Care Navigator Intervention group will receive up to 10 telephone calls from a care navigator for 5 months post-operatively~Care Navigator: Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharged from the hospital for 5 months after their total knee replacement.~Subjects assigned to the usual Care group will receive current standard of post-operative care"
764154|NCT01540825|B12|Baseline|Total|Total of all reporting groups
764160|NCT01540825|B6|Baseline|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764161|NCT01540825|B5|Baseline|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764162|NCT01540825|B4|Baseline|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764163|NCT01540825|B3|Baseline|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764164|NCT01540825|B2|Baseline|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764165|NCT01540825|B1|Baseline|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
764166|NCT01540825|P11|Participant Flow|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764167|NCT01540825|P10|Participant Flow|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764168|NCT01540825|P9|Participant Flow|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764169|NCT01540825|P8|Participant Flow|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764170|NCT01540825|P7|Participant Flow|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764171|NCT01540825|P6|Participant Flow|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764172|NCT01540825|P5|Participant Flow|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764173|NCT01540825|P4|Participant Flow|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764174|NCT01540825|P3|Participant Flow|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764179|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764180|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764181|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764182|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764183|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764184|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764185|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764186|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764187|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
764188|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764189|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764190|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764191|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764192|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764193|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764194|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764195|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764196|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764197|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764198|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
764199|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764200|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764201|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764202|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764203|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764204|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764205|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764206|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764207|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764208|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764209|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764210|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764211|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764212|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764213|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764214|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764215|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764216|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764217|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764218|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764219|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764220|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764221|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764222|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764223|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764224|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764225|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764226|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764227|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764228|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764229|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764230|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764319|NCT01540370|B1|Baseline|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
764231|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764232|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764233|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764234|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764235|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764236|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764237|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764238|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764239|NCT01540825|O10|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764240|NCT01540825|O9|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764241|NCT01540825|O8|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764242|NCT01540825|O7|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764243|NCT01540825|O6|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764244|NCT01540825|O5|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764245|NCT01540825|O4|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764246|NCT01540825|O3|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764247|NCT01540825|O2|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764248|NCT01540825|O1|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764249|NCT01540825|O11|Outcome|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764250|NCT01540825|O10|Outcome|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764251|NCT01540825|O9|Outcome|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764252|NCT01540825|O8|Outcome|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
764253|NCT01540825|O7|Outcome|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764254|NCT01540825|O6|Outcome|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764255|NCT01540825|O5|Outcome|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764256|NCT01540825|O4|Outcome|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764257|NCT01540825|O3|Outcome|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764258|NCT01540825|O2|Outcome|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764259|NCT01540825|O1|Outcome|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
764260|NCT01540825|E11|Reported Event|BI 113608 200mg|Participants received a single dose of BI 113608 200mg powder for oral solution
764261|NCT01540825|E10|Reported Event|BI 113608 150mg|Participants received a single dose of BI 113608 150mg powder for oral solution
764262|NCT01540825|E9|Reported Event|BI 113608 100mg|Participants received a single dose of BI 113608 100mg powder for oral solution
764263|NCT01540825|E8|Reported Event|BI 113608 50mg|Participants received a single dose of BI 113608 50mg powder for oral solution
766255|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
764264|NCT01540825|E7|Reported Event|BI 113608 20mg|Participants received a single dose of BI 113608 20mg powder for oral solution
764265|NCT01540825|E6|Reported Event|BI 113608 10mg|Participants received a single dose of BI 113608 10mg powder for oral solution
764266|NCT01540825|E5|Reported Event|BI 113608 5mg|Participants received a single dose of BI 113608 5mg powder for oral solution
764267|NCT01540825|E4|Reported Event|BI 113608 2mg|Participants received a single dose of BI 113608 2mg powder for oral solution
764268|NCT01540825|E3|Reported Event|BI 113608 1mg|Participants received a single dose of BI 113608 1mg powder for oral solution
764269|NCT01540825|E2|Reported Event|BI 113608 0.5mg|Participants received a single dose of BI 113608 0.5mg powder for oral solution
764270|NCT01540825|E1|Reported Event|Placebo|Participants received a single dose of a placebo oral solution of volume matching the respective dose group
764271|NCT01540773|B1|Baseline|All Study Participants|Participants received either an egg breakfast or an isocaloric bagel breakfast.
764272|NCT01540773|P2|Participant Flow|Placebo - Amino Acid Supplement|Placebo
764273|NCT01540773|P1|Participant Flow|Amino Acid Supplement - Placebo|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
764274|NCT01540773|O2|Outcome|Placebo - Amino Acid Supplement|Placebo
764275|NCT01540773|O1|Outcome|Amino Acid Supplement - Placebo|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
764276|NCT01540773|O2|Outcome|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
764277|NCT01540773|O1|Outcome|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative~A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined."
764278|NCT01540773|O2|Outcome|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
814923|NCT01344460|O3|Outcome|Computed Tomographic Angiography|
764279|NCT01540773|O1|Outcome|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative~A single dose of amino acids can significantly increase GH levels after 120 minutes in healthy men and women. Whether these GH changes persist over a longer duration or have other positive effects is being further examined."
764280|NCT01540773|E2|Reported Event|Placebo|"Non-Active~Placebo: A non-active orally administered supplement of the proprietary amino acid derivative"
764281|NCT01540773|E1|Reported Event|Amino Acid Supplement|"supplements with the proprietary amino acid derivative blend.~Amino acid supplement: An orally administered supplement of the proprietary amino acid derivative"
764282|NCT01540487|B3|Baseline|Total|Total of all reporting groups
764283|NCT01540487|B2|Baseline|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
764284|NCT01540487|B1|Baseline|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
764285|NCT01540487|P2|Participant Flow|Lina 2.5mg, Metformin 500mg|All patients receiving Linagliptin 2.5mg and Metformin 500mg.
764286|NCT01540487|P1|Participant Flow|Lina 2.5mg, Metformin 850mg|All patients receiving Linagliptin 2.5mg and Metformin 850mg.
764287|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764288|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
764289|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764290|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764291|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764292|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
764293|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764294|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764295|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764296|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
764297|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764298|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764299|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764300|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
764301|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764302|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764303|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764304|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
766256|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care~standard care"
764305|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764306|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764307|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764308|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
764309|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764310|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764311|NCT01540487|O4|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764312|NCT01540487|O3|Outcome|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
764313|NCT01540487|O2|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764314|NCT01540487|O1|Outcome|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764315|NCT01540487|E4|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as single tablets.
764316|NCT01540487|E3|Reported Event|Linagliptin 2.5 mg, Metformin 500 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 500 mg Metformin as a fixed dose combination (FDC) tablet.
764317|NCT01540487|E2|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as Single Tablets|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as single tablets.
764318|NCT01540487|E1|Reported Event|Linagliptin 2.5 mg, Metformin 850 mg as FDC Tablet|Patients receiving 2.5 mg Linagliptin and 850 mg Metformin as a fixed dose combination (FDC) tablet.
764322|NCT01540370|O1|Outcome|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
764323|NCT01540370|E1|Reported Event|Patients With OAG and/or OHT|Patients with OAG and/or OHT.
764324|NCT01540266|B7|Baseline|Total|Total of all reporting groups
764325|NCT01540266|B6|Baseline|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764326|NCT01540266|B5|Baseline|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764327|NCT01540266|B4|Baseline|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764328|NCT01540266|B3|Baseline|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764329|NCT01540266|B2|Baseline|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764330|NCT01540266|B1|Baseline|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764331|NCT01540266|P6|Participant Flow|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764332|NCT01540266|P5|Participant Flow|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764333|NCT01540266|P4|Participant Flow|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764334|NCT01540266|P3|Participant Flow|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764335|NCT01540266|P2|Participant Flow|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764336|NCT01540266|P1|Participant Flow|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764337|NCT01540266|O6|Outcome|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764338|NCT01540266|O5|Outcome|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764339|NCT01540266|O4|Outcome|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764340|NCT01540266|O3|Outcome|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764341|NCT01540266|O2|Outcome|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764342|NCT01540266|O1|Outcome|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764343|NCT01540266|E6|Reported Event|Third Year medical_non-structured|"Third year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764344|NCT01540266|E5|Reported Event|Third Year medical_structured|"Third year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764345|NCT01540266|E4|Reported Event|First Year mediclal_non-structured|"First year medical students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764346|NCT01540266|E3|Reported Event|First Year medical_structured|"First year medical students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764347|NCT01540266|E2|Reported Event|First Year psychology_non-structured|"First year psychology students who watched the video where the physician gives non-structured information to the patient~no information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764348|NCT01540266|E1|Reported Event|First Year psychology_structured|"First year psychology students who watched the video where the physician gives structured information to the patient~Information structuring: Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form"
764349|NCT01540162|B3|Baseline|Total|Total of all reporting groups
764350|NCT01540162|B2|Baseline|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
764351|NCT01540162|B1|Baseline|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
764352|NCT01540162|P2|Participant Flow|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
764353|NCT01540162|P1|Participant Flow|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
764354|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
764355|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
764356|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
764357|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
764358|NCT01540162|O2|Outcome|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
764359|NCT01540162|O1|Outcome|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
764360|NCT01540162|E2|Reported Event|Group II|Patients of group II remain unexposed to the probiotic Mutaflor.
764361|NCT01540162|E1|Reported Event|Group I|Patients of group I are exposed to the probiotic Mutaflor: 1 ml once a day during first week of life, and three times per week during the second and third week of life.
764362|NCT01540045|B1|Baseline|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
764363|NCT01540045|P1|Participant Flow|Pre-chemotherapy Patientes =40|Outpatients from National Cancer Institute with stage III and IV NSCLC candidates for 1 st line chemotherapy paclitaxel-cisplatin based agreeing to participate in the study
764364|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764365|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764366|NCT01540045|O2|Outcome|Post-chemotherapy Patients|patients with high or low sensibility to umami, bitter and sweet tastes post-chemotherapy
764367|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|patients with high or low sensibility to umami, bitter and sweet tastes pre-chemotherapy
764368|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764369|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764370|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764371|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764372|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764373|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764374|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764375|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764376|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764377|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764378|NCT01540045|O2|Outcome|> Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
764747|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
764379|NCT01540045|O1|Outcome|< or = Umami Recognition Thresholds|quality of life scales in patient with more or the same sensibility to recognize the umami taste
764380|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"peripheral neuropathy patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
764381|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"peripheral neuropathy in patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
764382|NCT01540045|O2|Outcome|< Umami Perception Thresholds|"patients with less sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(< UPT) = less sensibility to umami perception"
764383|NCT01540045|O1|Outcome|> or = Umami Perception Thresholds|"patients with more or the same sensibility to umami taste pre-post chemotherapy in NSCLC patients.~(> UPT) = more sensibility to umami perception"
764384|NCT01540045|O2|Outcome|HRQL Post-chemotherapy|Score of scale HRQL EORTC
764385|NCT01540045|O1|Outcome|HRQL Pre-chemotherapy|Score of scale HRQL EORTC
764386|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764387|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764388|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION < Sweet perception thresholds after chemotherapy
764389|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|IRON CONSUMPTION ≥ Sweet perception thresholds after chemotherapy
764390|NCT01540045|O2|Outcome|< Sweet Perception Thresholds After Chemotherapy|patient with less sensibility to perceive sweet taste from food
764391|NCT01540045|O1|Outcome|≥ Sweet Perception Thresholds After Chemotherapy|patient with more sensibility to perceive sweet taste from food
764392|NCT01540045|O2|Outcome|Post-chemotherapy Patientes|Subjective Global Assessment post chemotherapy
764393|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|Subjective Global Assessment pre-chemotherapy
764394|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body mass index post chemotherapy
764395|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body mass index pre-chemotherapty
764396|NCT01540045|O2|Outcome|Post-chemotherapy Patients|body composition post chemotherapy
764397|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|body composition pre-chemotherapy
764398|NCT01540045|O2|Outcome|Post-chemotherapy Patients|measurement post-chemotherapy
764399|NCT01540045|O1|Outcome|Pre-chemotherapy Patientes|measurement pre-chemotherapy
764400|NCT01540045|E1|Reported Event|LUNG CANCER PATIENTS|any toxicity resulting from exposure to chemotherapy with which patients are treated are unrelated to this study, which was observational
764401|NCT01539980|B1|Baseline|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764402|NCT01539980|P1|Participant Flow|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764403|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764466|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
764404|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764405|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764406|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764407|NCT01539980|O1|Outcome|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764408|NCT01539980|E1|Reported Event|Sericin Scaffold|Sericin scaffold: Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
764409|NCT01539811|B3|Baseline|Total|Total of all reporting groups
764410|NCT01539811|B2|Baseline|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
764435|NCT01539642|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
764748|NCT01537133|O4|Outcome|Healthy Control|
764411|NCT01539811|B1|Baseline|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
764412|NCT01539811|P2|Participant Flow|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
764413|NCT01539811|P1|Participant Flow|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
764414|NCT01539811|O2|Outcome|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
764415|NCT01539811|O1|Outcome|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
764416|NCT01539811|E2|Reported Event|Long Course Antibiotics|"Surgical intervention followed by a long course of antibiotics (>2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Long course antibiotics: Long course (>2 weeks) of antibiotics will be prescribed"
764417|NCT01539811|E1|Reported Event|Short Course Antibiotics|"Surgical intervention followed by short course of antibiotics (<2 weeks)~Surgical incision and drainage of diabetic foot infection: Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot~Short course antibiotics: Short course (<2 weeks) of antibiotics will be prescribed"
764418|NCT01539759|B3|Baseline|Total|Total of all reporting groups
764419|NCT01539759|B2|Baseline|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
764420|NCT01539759|B1|Baseline|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
764421|NCT01539759|P2|Participant Flow|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
764422|NCT01539759|P1|Participant Flow|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
764423|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
764424|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
764465|NCT01539525|O1|Outcome|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764425|NCT01539759|O2|Outcome|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
764426|NCT01539759|O1|Outcome|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
764427|NCT01539759|E2|Reported Event|Immediate Postplacental IUD Placement|"Women randomized to this arm will receive on IUD at time of cesarean delivery, immediately after the delivery of the placenta~Immediate Postplacental Placement of an IUD during cesarean delivery: Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta"
764428|NCT01539759|E1|Reported Event|Interval IUD Placement|Women randomized to this arm will be scheduled for their IUD placement 4-8 weeks after their cesarean delivery
764429|NCT01539642|B3|Baseline|Total|Total of all reporting groups
764430|NCT01539642|B2|Baseline|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
764431|NCT01539642|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
764432|NCT01539642|P2|Participant Flow|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
764433|NCT01539642|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
764434|NCT01539642|O2|Outcome|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
764436|NCT01539642|E2|Reported Event|Placebo Sufentanil NanoTab PCA System|Placebo Sufentanil NanoTab PCA System : Placebo NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
764437|NCT01539642|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|Sufentanil NanoTab PCA System/15 mcg : 15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours. Patient may elect to remain in study for up to 72 hours
764438|NCT01539590|B3|Baseline|Total|Total of all reporting groups
764439|NCT01539590|B2|Baseline|Placebo|Normal saline. Daily intravenous administration for four (4) days.
764440|NCT01539590|B1|Baseline|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
764441|NCT01539590|P2|Participant Flow|Placebo; 4 Daily Doses|Placebo: Normal saline; Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
764442|NCT01539590|P1|Participant Flow|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days ; 10 to 12 minutes; small molecule mimetic of hepatocyte growth factor
764443|NCT01539590|O2|Outcome|Placebo, 4 Daily Doses|Normal saline. Daily intravenous administration for four (4) days.
764444|NCT01539590|O1|Outcome|BB3, 4 Daily Doses|BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days
764445|NCT01539590|E2|Reported Event|Placebo|"Normal saline~Placebo: Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight."
764446|NCT01539590|E1|Reported Event|BB3 Small Molecule Mimetic of Hepatocyte Growth Factor|"small molecule mimetic of hepatocyte growth factor/scatter factor~BB3: Daily intravenous administration of 2 mg/kg BB3 for four (4) days"
764447|NCT01539538|B3|Baseline|Total|Total of all reporting groups
764448|NCT01539538|B2|Baseline|Morphine IV PCA|
764449|NCT01539538|B1|Baseline|Sufentanil NanoTab PCA System/15 mcg|
764450|NCT01539538|P2|Participant Flow|Morphine IV PCA|
764451|NCT01539538|P1|Participant Flow|Sufentanil NanoTab PCA System/15 mcg|
764452|NCT01539538|O2|Outcome|Morphine IV PCA|
764453|NCT01539538|O1|Outcome|Sufentanil NanoTab PCA System/15 mcg|
764454|NCT01539538|E2|Reported Event|Morphine IV PCA|
764455|NCT01539538|E1|Reported Event|Sufentanil NanoTab PCA System/15 mcg|
764456|NCT01539525|B4|Baseline|Total|Total of all reporting groups
764457|NCT01539525|B3|Baseline|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
764458|NCT01539525|B2|Baseline|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764459|NCT01539525|B1|Baseline|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764460|NCT01539525|P3|Participant Flow|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
764461|NCT01539525|P2|Participant Flow|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764462|NCT01539525|P1|Participant Flow|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764463|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Treatment as Usual: Subjects given a brochure listing relevant recovery resources in the local area."
764464|NCT01539525|O2|Outcome|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
766257|NCT01532934|O2|Outcome|Standard Care|"standard care~standard care: standard care"
764467|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764468|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764469|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
764470|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764471|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764472|NCT01539525|O3|Outcome|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
764473|NCT01539525|O2|Outcome|Motivational Interview-Computer|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764474|NCT01539525|O1|Outcome|Motivational Interview-Nurse|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764475|NCT01539525|E3|Reported Event|Treatment as Usual|"No intervention- resource list provided.~Resource brochure: Subjects given a brochure listing relevant recovery resources in the local area."
764476|NCT01539525|E2|Reported Event|Motivational Interview-Electronic|"Motivational Interview provided by an interactive computer program.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764477|NCT01539525|E1|Reported Event|Motivational Interview|"Motivational interview provided by a clinical research nurse or physician.~Motivational Interview: Motivational Interview provided by either a Nurse or Computer"
764478|NCT01539512|B3|Baseline|Total|Total of all reporting groups
764584|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764479|NCT01539512|B2|Baseline|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764480|NCT01539512|B1|Baseline|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764481|NCT01539512|P2|Participant Flow|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764482|NCT01539512|P1|Participant Flow|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764483|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764484|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764485|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764486|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764487|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764488|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764489|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764490|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764491|NCT01539512|O2|Outcome|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764492|NCT01539512|O1|Outcome|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764493|NCT01539512|E2|Reported Event|Placebo + Rituximab|Placebo to match idelalisib administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764494|NCT01539512|E1|Reported Event|Idelalisib + Rituximab|Idelalisib 150 mg tablet administered orally twice daily plus rituximab (8 intravenous doses through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter)
764495|NCT01539317|B3|Baseline|Total|Total of all reporting groups
764496|NCT01539317|B2|Baseline|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764497|NCT01539317|B1|Baseline|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764498|NCT01539317|P2|Participant Flow|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764499|NCT01539317|P1|Participant Flow|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764500|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764501|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764636|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764502|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764503|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764504|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764505|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764506|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764507|NCT01539317|O1|Outcome|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764508|NCT01539317|O3|Outcome|Open Label|"During Open-label Lidocaine 8 weeks~Each prior arm converted to use of open label lidocaine for 2 further months."
764509|NCT01539317|O2|Outcome|Topical Liquid Lidocaine|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
764510|NCT01539317|O1|Outcome|Topical Saline|"Topical liquid lidocaine: active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule~Topical saline: saline applied to the vestibule mucosa will not reverse the local tenderness"
764511|NCT01539317|E2|Reported Event|Topical Saline|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764512|NCT01539317|E1|Reported Event|Topical Liquid Lidocaine|Topical liquid lidocaine: Comparison of topical liquid lidocaine to placebo on application to the vulvar vestibule
764513|NCT01539135|B3|Baseline|Total|Total of all reporting groups
764514|NCT01539135|B2|Baseline|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764515|NCT01539135|B1|Baseline|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764516|NCT01539135|P2|Participant Flow|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764517|NCT01539135|P1|Participant Flow|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764518|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764519|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764520|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764521|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764522|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764523|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764524|NCT01539135|O2|Outcome|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764525|NCT01539135|O1|Outcome|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764526|NCT01539135|E2|Reported Event|TaperGuard Endotracheal Tube|"TaperGuard endotracheal tube with taper shaped cuff with 20 cc methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764527|NCT01539135|E1|Reported Event|Hi-Lo Endotracheal Tube|"Hi-Lo endotracheal tube with barrel shaped cuff with 20 cc of methylene blue instilled above the cuff once post intubation for the duration of the surgical procedure~Methylene Blue: 20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure"
764637|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764638|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
764528|NCT01539083|B1|Baseline|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
764529|NCT01539083|P3|Participant Flow|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764530|NCT01539083|P2|Participant Flow|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764531|NCT01539083|P1|Participant Flow|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
764532|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764533|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764534|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764535|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764536|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764537|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764538|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764539|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764540|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764541|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764542|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764543|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764544|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764545|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764639|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
777583|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
764546|NCT01539083|O2|Outcome|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764547|NCT01539083|O1|Outcome|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764548|NCT01539083|E3|Reported Event|Bortezomib + Thalidomide + Prednisolone [VTP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received bortezomib 1.3 mg/m^2 SC every 2 weeks for 32 weeks in addition to thalidomide 100 mg orally, once daily for a maximum of 12 months or until disease progression and prednisolone 50 mg orally, on every alternate day until disease progression.
764549|NCT01539083|E2|Reported Event|Thalidomide + Prednisolone [TP Consolidation]|Participants who completed induction phase entered in the consolidated treatment phase and received thalidomide 100 mg orally, once daily until disease progression (up to maximum of 12 months) and prednisolone 50 mg orally, on every alternate day until disease progression.
764550|NCT01539083|E1|Reported Event|Bortezomib + Cyclophosphamide + Dexamethasone [VCD Induction]|Participants received bortezomib (Velcade) 1.3 milligram per square meter (mg/m^2) subcutaneously (SC) on Days 1, 4, 8, and 11; cyclophosphamide 300 mg/m^2 orally on Days 1, 8, and 15; and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11, and 12 in three 21-day treatment cycles. Participants who completed induction phase entered into the consolidation treatment phase.
764551|NCT01539070|B3|Baseline|Total|Total of all reporting groups
764585|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764586|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764749|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
764552|NCT01539070|B2|Baseline|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
764553|NCT01539070|B1|Baseline|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
764554|NCT01539070|P2|Participant Flow|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
764555|NCT01539070|P1|Participant Flow|Eating and Physical Activity Counseling|"Eating and physical activity counseling: The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
764556|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
764557|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
764558|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
764559|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
764640|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764560|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
764561|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
764562|NCT01539070|O2|Outcome|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
764587|NCT01537900|E1|Reported Event|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764588|NCT01537835|B4|Baseline|Total|Total of all reporting groups
764750|NCT01537133|O2|Outcome|Atopic Asthmatics Treated With Placebo|
764563|NCT01539070|O1|Outcome|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
764564|NCT01539070|E2|Reported Event|Usual Care|According to the existing clinical practice guide within IMSS, obese children may be referred to a nutritionist if the physician considers it necessary, given general dietary advice by the attending physician, or, if necessary, sent for laboratory analyses of blood lipids and glucose. We gave the parents the height and weight results from the measurement of their child and recommended they share results with their physician in their next medical consultation.
764565|NCT01539070|E1|Reported Event|Eating and Physical Activity Counseling|"Eating and physical activity counseling : The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
764566|NCT01538862|B1|Baseline|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
764567|NCT01538862|P1|Participant Flow|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
764568|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
764569|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d subcutaneously for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d subcutaneously for 7 days"
764570|NCT01538862|O1|Outcome|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d subcutaneously for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d subcutaneously for 7 days"
764571|NCT01538862|E1|Reported Event|Granulocyte Colony Stimulating Factor (GCSF)|"GCSF 10mcg/kg/d SQ for 7 days~Granulocyte Colony Stimulating Factor (GCSF): G-CSF 10mcg/kg/d SQ for 7 days"
764572|NCT01538472|B1|Baseline|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
764573|NCT01538472|P1|Participant Flow|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with 1,3-bis(2-chloroethyl)-1-nitrosourea bis-chloronitrosourea (BCNU) (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
764574|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
764575|NCT01538472|O1|Outcome|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
764576|NCT01538472|E1|Reported Event|Y Zevalin + BEAM|Rituxan 250 mg/m2 preceding imaging dose of 111In Zevalin (5 mCi); additional infusion 250 mg/m2 Rituxan followed by therapeutic dose of 0.4 mCi/kg 90Y Zevalin received one week after Rituxan/111In Zevalin infusions. One week later, chemotherapy received with BCNU (300 mg/m2, intravenously (IV) day -6) VP-16 (200 mg/m2 IV every 12 hours, days -5 to -2) cytarabine (200 mg/m2 IV every 12 hours, days -5 to -2) and melphalan (140 mg/m2 IV day -1). Autologous stem cell infused on day 0 then Rituximab 1000 mg/m2 on days +1, and +8 post transplantation.
764577|NCT01537900|B1|Baseline|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764578|NCT01537900|P1|Participant Flow|Grazoprevir 100 mg|Participants received GZR 100 mg once daily (q.d.) for 7 days. Liver FNA was performed on Day 7.
764579|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764580|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764581|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764582|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764583|NCT01537900|O1|Outcome|Grazoprevir 100 mg|Participants received GZR 100 mg q.d. for 7 days. Liver FNA was performed on Day 7.
764751|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
764589|NCT01537835|B3|Baseline|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764590|NCT01537835|B2|Baseline|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764591|NCT01537835|B1|Baseline|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
764592|NCT01537835|P3|Participant Flow|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764593|NCT01537835|P2|Participant Flow|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764594|NCT01537835|P1|Participant Flow|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
764595|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764596|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764597|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
764598|NCT01537835|O3|Outcome|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764599|NCT01537835|O2|Outcome|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764600|NCT01537835|O1|Outcome|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
764641|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
766261|NCT01532934|E2|Reported Event|Standard Care|There were no adverse events for members of this group.
764601|NCT01537835|E3|Reported Event|Antimicrobial Scrubs 2|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764602|NCT01537835|E2|Reported Event|Antimicrobial Scrubs 1|"Participants will be randomized to one of three types of uniforms. In this arm, the participants will wear one of two types of antimicrobial uniforms. These are commercially available and registered with the Environmental Protective Agency.~Antimicrobial Scrubs: Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties."
764603|NCT01537835|E1|Reported Event|Standard Scrubs|Participants will be randomized to one of three types of uniforms. This arm is the standard scrub arm. The participants will wear new standard scrubs.
764604|NCT01537783|B3|Baseline|Total|Total of all reporting groups
764605|NCT01537783|B2|Baseline|Standard of Care|Standard emergency department care
764606|NCT01537783|B1|Baseline|Intervention Group|Standard emergency department care plus eradication protocol
764607|NCT01537783|P2|Participant Flow|Intervention|Usual emergency department care plus eradication protocol
764608|NCT01537783|P1|Participant Flow|Standard of Care|Usual emergency department care
764609|NCT01537783|O2|Outcome|Standard of Care|In this arm, patients receive routine care of their abscess, which may or may not include either topical or oral antibiotics, at the discretion of the treating clinician.
764653|NCT01537666|E5|Reported Event|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764610|NCT01537783|O1|Outcome|Intervention Group|"In this arm, patients are treated with chlorhexidine scrubs once a day for 5 days and mupirocin nasal ointment inserted to both nostrils twice a day for 5 days. Both treatments are begun 7 days after enrollment, or when the abscess has healed fully if it has not healed by day 7.~Chlorhexidine gluconate: Scrubs applied once a day for 5 days~Mupirocin: Nasal mupirocin applied topically to both nostrils twice a day for 5 days"
764611|NCT01537783|E2|Reported Event|Standard of Care|Standard emergency department care
764612|NCT01537783|E1|Reported Event|Intervention Group|Standard emergency department care plus eradication protocol
764613|NCT01537666|B5|Baseline|Total|Total of all reporting groups
764614|NCT01537666|B4|Baseline|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764615|NCT01537666|B3|Baseline|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
764616|NCT01537666|B2|Baseline|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
764617|NCT01537666|B1|Baseline|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
764618|NCT01537666|P4|Participant Flow|AeroVanc 32 and 80 mg in CF Patients|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764619|NCT01537666|P3|Participant Flow|AeroVanc 80 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
764620|NCT01537666|P2|Participant Flow|AeroVanc 32 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
764621|NCT01537666|P1|Participant Flow|Aerovanc 16 mg (Subset IV Vancomycin) in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation (N=6)/ Subset received IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration (N=2 from this group, 6 overall)
764622|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764623|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764624|NCT01537666|O2|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764625|NCT01537666|O1|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764626|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
764627|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764628|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764629|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764630|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
764631|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764632|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764633|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764634|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
764635|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764642|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|IV vancomycin hydrochloride : Vancomycin hydrochloride solution for intravenous administration
764643|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764644|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764645|NCT01537666|O1|Outcome|Aerovanc 16 mg in Healthy Volunteers|AeroVanc : Vancomycin hydrochloride dry powder for inhalation
764646|NCT01537666|O6|Outcome|AeroVanc 80 mg in Cystic Fibrosis Patients|Single inhaled dose of 80 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764647|NCT01537666|O5|Outcome|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764648|NCT01537666|O4|Outcome|IV Vancomycin 250 mg in Healthy Volunteers|Single IV dose of Vancomycin 250 mg in Healthy Volunteers. Group comprised of 2 subjects from each of the AeroVanc in Healthy Volunteers groups.
764649|NCT01537666|O3|Outcome|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
764650|NCT01537666|O2|Outcome|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
764651|NCT01537666|O1|Outcome|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
764652|NCT01537666|E6|Reported Event|IV Vancomycin 250 mg in Healthy Volunteers|Comprised of 2 patients from each of the AeroVanc in Healthy Volunteer groups.
764752|NCT01537133|O4|Outcome|Healthy Control|
764654|NCT01537666|E4|Reported Event|AeroVanc 32 mg in Cystic Fibrosis Patients|Single inhaled dose of 32 mg AeroVanc. One patient withdrew after receiving a 32 mg dose and was replaced with a patient who only received an 80 mg dose.
764655|NCT01537666|E3|Reported Event|AeroVanc 80 mg in Healthy Volunteers|Single inhaled dose of 80 mg AeroVanc in health volunteers.
764656|NCT01537666|E2|Reported Event|AeroVanc 32 mg in Healthy Volunteers|Single inhaled dose of 32 mg AeroVanc in health volunteers.
764657|NCT01537666|E1|Reported Event|AeroVanc 16 mg in Healthy Volunteers|Single inhaled dose of 16 mg AeroVanc in health volunteers.
764658|NCT01537549|B1|Baseline|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
764659|NCT01537549|P1|Participant Flow|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
764660|NCT01537549|O2|Outcome|Juvenon at 1 Month|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily (1 month)
764661|NCT01537549|O1|Outcome|Juvenon at Baseline|at Baseline, no drug taken yet
764662|NCT01537549|O1|Outcome|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
764663|NCT01537549|E1|Reported Event|Juvenon|alpha-lipoic acid and L-acetyl carnitine: alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
764664|NCT01537432|B3|Baseline|Total|Total of all reporting groups
764665|NCT01537432|B2|Baseline|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
764666|NCT01537432|B1|Baseline|AIN457 300mg|AIN457 300mg subcutaneously weekly
764667|NCT01537432|P2|Participant Flow|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
764668|NCT01537432|P1|Participant Flow|AIN457 300mg|AIN457 300mg subcutaneously weekly
764669|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
764670|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
764671|NCT01537432|O2|Outcome|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
764672|NCT01537432|O1|Outcome|AIN457 300mg|AIN457 300mg subcutaneously weekly
764673|NCT01537432|E2|Reported Event|Placebo|Placebo subcutaneously weekly until Week 12. At week 12, participants received AIN457 300mg subcutaneously weekly.
764674|NCT01537432|E1|Reported Event|AIN457 300 mg|AIN457 300mg subcutaneously weekly
764675|NCT01537367|B4|Baseline|Total|Total of all reporting groups
764676|NCT01537367|B3|Baseline|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
764677|NCT01537367|B2|Baseline|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
764678|NCT01537367|B1|Baseline|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient related to making and seeing clinic appointments.
764679|NCT01537367|P3|Participant Flow|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
764728|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
764680|NCT01537367|P2|Participant Flow|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
764681|NCT01537367|P1|Participant Flow|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
764682|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
764683|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
764684|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
764685|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
764686|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
764687|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
764688|NCT01537367|O3|Outcome|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
764689|NCT01537367|O2|Outcome|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
764690|NCT01537367|O1|Outcome|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
764691|NCT01537367|E3|Reported Event|Standard of Care|Participants randomized to the SOC arm received the usual attention and encouragement to attend all clinic visits that prevailed at the clinic at the time of this intervention. This attention could include the routine advice from a nurse, personal or robo reminder calls before a next clinic visit. Contacts with case managers and social workers related to clinic appointments could also occur, per the clinic's standard procedures.
764692|NCT01537367|E2|Reported Event|Enhanced Contact-plus Behavioral Skills|"This arm was described in the summary/Detailed Description as the longer comprehensive intervention arm. Patients assigned to this arm were required to return to the clinic within the next two weeks after enrollment to receive a one-to-two hour training in elements of behavioral skills relevant to improved clinic attendance. The mixture of elements was determined by the interventionist in a discussion with the patient at this special study visit. Subsequent contacts of the interventionist with patients in this arm would refer to these behavioral skills elements and to making and keeping clinic appointments."
764693|NCT01537367|E1|Reported Event|Enhanced Contact-only|The enhanced contact only arm was described in the summary/Detailed Description as the shorter intervention. This arm did not require any additional special study visits after enrollment. The contacts of the interventionist with the patient were related to making and keeping clinic appointments.
764694|NCT01537315|B3|Baseline|Total|Total of all reporting groups
764695|NCT01537315|B2|Baseline|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
766558|NCT01530243|B4|Baseline|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
764696|NCT01537315|B1|Baseline|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
764697|NCT01537315|P2|Participant Flow|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
764698|NCT01537315|P1|Participant Flow|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
764699|NCT01537315|O2|Outcome|Hydroxychloroquine|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or matching placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
764700|NCT01537315|O1|Outcome|Matching Placebo|"Patients with cardiovascular disease (CVD) and chronic kidney disease (CKD) will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching placebo capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
764743|NCT01537133|P1|Participant Flow|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
764744|NCT01537133|O4|Outcome|Healthy Control|
764745|NCT01537133|O3|Outcome|Atopic Non-asthmatics|
764701|NCT01537315|E2|Reported Event|Hydroxychloroquine|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Hydroxychloroquine: 200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)"
764702|NCT01537315|E1|Reported Event|Matching Placebo|"Patients with CVD and CKD will be randomized to either hydroxychloroquine (HCQ) or placebo in a 3:1 ratio (approximately 39 to HCQ and 13 to placebo)~Placebo comparator: matching capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months"
764703|NCT01537302|B1|Baseline|Ocelot|CTO crossing in femoropopliteal arteries using the Ocelot System
764704|NCT01537302|P1|Participant Flow|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
764705|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
764706|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
764707|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
764708|NCT01537302|O1|Outcome|Treatment Arm|CTO crossing in femoropopliteal arteries using the Ocelot System
764709|NCT01537302|E1|Reported Event|Treatment Arm|CTO crossing in femoropopliteal arteries CONNECT II: CTO crossing in femoropopliteal arteries using the Ocelot System
764710|NCT01537198|B1|Baseline|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
764711|NCT01537198|P1|Participant Flow|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of respiratory syncytial virus (RSV) in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
764712|NCT01537198|O1|Outcome|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
764713|NCT01537198|E1|Reported Event|Pediatric Participants at High Risk of RSV|Pediatric participants at high risk of RSV in need of the prevention of serious lower respiratory tract disease caused by RSV were prescribed Synagis prophylaxis in usual practice according to the approved Korean product label. The decision to prescribe or not to prescribe Synagis was taken prior to a participant’s enrollment in the study.
764714|NCT01537185|B5|Baseline|Total|Total of all reporting groups
764715|NCT01537185|B4|Baseline|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764716|NCT01537185|B3|Baseline|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764717|NCT01537185|B2|Baseline|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
764718|NCT01537185|B1|Baseline|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764719|NCT01537185|P4|Participant Flow|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
764720|NCT01537185|P3|Participant Flow|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
764721|NCT01537185|P2|Participant Flow|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
764722|NCT01537185|P1|Participant Flow|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764723|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764724|NCT01537185|O3|Outcome|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764725|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
764726|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764727|NCT01537185|O4|Outcome|Cohort 3 SPWVC+Alum 600 mcg|each individual receiving 3 vaccinations of the same dose 28 days apart
766559|NCT01530243|B3|Baseline|Tolterodine|Tolterodine: 2 mg daily
764729|NCT01537185|O2|Outcome|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
764730|NCT01537185|O1|Outcome|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764731|NCT01537185|E4|Reported Event|Cohort 3 SPWCV+Alum 600 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764732|NCT01537185|E3|Reported Event|Cohort 2 SPWCV+Alum 300 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764733|NCT01537185|E2|Reported Event|Normal Saline Injection|"placebo group within each cohort receive 3 injections of normal saline 28 days apart~normal saline injection: 3 cohorts of normal saline injection"
764734|NCT01537185|E1|Reported Event|Cohort 1 SPWCV+Alum 100 mcg|each individual receiving 3 vaccinations of same dose 28 days apart
764735|NCT01537133|B5|Baseline|Total|Total of all reporting groups
764736|NCT01537133|B4|Baseline|Healthy Control|
764737|NCT01537133|B3|Baseline|Atopic Non-asthmatics|
764738|NCT01537133|B2|Baseline|Atopic Asthmatics Treated With Placebo|Placebo fluticasone (one puff, twice a day)
764739|NCT01537133|B1|Baseline|Atopic Asthmatics Treated With Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
764740|NCT01537133|P4|Participant Flow|Atopic Non-asthmatics|
764741|NCT01537133|P3|Participant Flow|Healthy Control|
764742|NCT01537133|P2|Participant Flow|Placebo|Placebo fluticasone (one puff, twice a day)
764755|NCT01537133|O1|Outcome|Atopic Asthmatics Treated With Inhaled Corticosteroids|
764756|NCT01537133|E2|Reported Event|Placebo|Placebo fluticasone (one puff, twice a day)
764757|NCT01537133|E1|Reported Event|Inhaled Corticosteroid|Fluticasone (250 mcg/puff, one puff, twice a day)
764758|NCT01537120|B1|Baseline|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
764759|NCT01537120|P1|Participant Flow|Placebo → Vildagliptin|Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily
764760|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
764761|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
764762|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
764763|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
764764|NCT01537120|O2|Outcome|Vildagliptin|Vildagliptin tablets 50 mg twice daily for 12 weeks
764765|NCT01537120|O1|Outcome|Placebo|Placebo tablets twice daily for 3 weeks
764766|NCT01537120|E2|Reported Event|Placebo|Placebo tablets twice daily for 3 weeks
764767|NCT01537120|E1|Reported Event|Vildagliptin 50 mg|Vildagliptin tablets 50 mg twice daily for 12 weeks
764768|NCT01537081|B4|Baseline|Total|Total of all reporting groups
764769|NCT01537081|B3|Baseline|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
764770|NCT01537081|B2|Baseline|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
764771|NCT01537081|B1|Baseline|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
764772|NCT01537081|P3|Participant Flow|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
764773|NCT01537081|P2|Participant Flow|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
764774|NCT01537081|P1|Participant Flow|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
764775|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
764876|NCT01536886|B2|Baseline|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
764776|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
764777|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex (600-mg) tablets and 1 placebo tablet matching the 200-mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
764778|NCT01537081|O3|Outcome|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
764779|NCT01537081|O2|Outcome|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
764780|NCT01537081|O1|Outcome|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
764781|NCT01537081|E3|Reported Event|Placebo|Double dummy technique was employed requiring a large number of tablets and water to be consumed. Participants were instructed to take 2 matching Mucinex placebo tablets combined with 1 matching IR guaifenesin placebo tablet by mouth, every 6 hours for 7 days.
764782|NCT01537081|E2|Reported Event|Immediate-release Guaifenesin 800 mg/Day|The dosing regimen and assessments timepoints were dictated by immediate-release guaifenesin (IR GGE). Participants were instructed to take 1 immediate-release guaifenesin (IR GGE) 200 mg tablet and 2 matching Mucinex placebo tablets by mouth, every 6 hours for 7 days.
765551|NCT01535365|E2|Reported Event|Cold|Application of cold to muscle sprain.
764783|NCT01537081|E1|Reported Event|Mucinex 2400 mg/Day|The study is designed to meet regulatory requirement outside the US. The dosing regimen and assessments timepoints were dictated by IR GGE and do not match approved Mucinex labeling. Participants were instructed to take 2 Mucinex 600-mg tablets and 1 placebo tablet matching the 200 mg IR guaifenesin tablet by mouth, every 12 hours for 7 days. To ensure complete blinding, on Hours 6 and 18, this treatment group took 2 matching Mucinex placebo tablets combined with 1 IR guaifenesin placebo tablet.
764784|NCT01537042|B3|Baseline|Total|Total of all reporting groups
764785|NCT01537042|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764786|NCT01537042|B1|Baseline|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764787|NCT01537042|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.~Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal."
764788|NCT01537042|P1|Participant Flow|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance.~Up to 3 weeks of Titration,~2 weeks of Maintenance,~Up to 4 days of Taper Period."
764789|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764790|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764791|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764792|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764793|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764794|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764795|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764796|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764797|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764798|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764799|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764800|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764801|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764872|NCT01536938|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
764802|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764803|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764804|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764805|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764806|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764807|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764808|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764809|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764810|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764811|NCT01537042|O4|Outcome|Rotigotine (Visit 6)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764812|NCT01537042|O3|Outcome|Placebo (Visit 6)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764813|NCT01537042|O2|Outcome|Rotigotine (Visit 2)|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764814|NCT01537042|O1|Outcome|Placebo (Visit 2)|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764815|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764816|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764817|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764818|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764819|NCT01537042|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764820|NCT01537042|O1|Outcome|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764821|NCT01537042|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patch~1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h."
764822|NCT01537042|E1|Reported Event|Placebo|"Transdermal patch matched according to patch size and appearance.~Placebo: Transdermal patch; Patches matching to active treatment patches in size and appearance."
764823|NCT01536951|B3|Baseline|Total|Total of all reporting groups
764824|NCT01536951|B2|Baseline|Part B (LY3009104, Moxifloxacin, or Placebo)|Participants were randomized to 1 of 6 treatment sequences during Part B of the study and received a single dose (LY3009104, moxifloxacin, or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as a 40-mg dose. Moxifloxacin was administered as a 400-mg tablet.
764825|NCT01536951|B1|Baseline|Part A (LY3009104 or Placebo)|Participants were randomized to 1 of 3 treatment sequences during Part A of the study and received a single dose (LY3009104 or placebo) in each period separated by a washout of at least 3 days. LY3009104 was administered as either 20-milligrams (mg), 30-mg or 40-mg dose.
764826|NCT01536951|P9|Participant Flow|Part B: Placebo, 40 mg LY3009104, Moxifloxacin|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Second Intervention: 40-mg LY3009104 dose administered orally once.~Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.~There was a washout of at least 3 days between each intervention."
764827|NCT01536951|P8|Participant Flow|Part B: 40 mg LY3009104, Moxifloxacin, Placebo|"First Intervention: 40-mg LY3009104 dose administered orally once.~Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
764828|NCT01536951|P7|Participant Flow|Part B: Moxifloxacin, Placebo, 40 mg LY3009104|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
764829|NCT01536951|P6|Participant Flow|Part B: Moxifloxacin, 40 mg LY3009104, Placebo|"First Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Second Intervention: 40-mg LY3009104 dose administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
764830|NCT01536951|P5|Participant Flow|Part B: Placebo, Moxifloxacin, 40 mg LY3009104|"First Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Second Intervention: A single 400-mg moxifloxacin tablet administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
764831|NCT01536951|P4|Participant Flow|Part B: 40 mg LY3009104, Placebo, Moxifloxacin|"First Intervention: 40-mg LY3009104 dose administered orally once.~Second Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~Third Intervention: A single 400-mg moxifloxacin tablet administered orally once.~There was a washout of at least 3 days between each intervention."
764832|NCT01536951|P3|Participant Flow|Part A: 20 mg LY3009104, Placebo, 40 mg LY3009104|"First Intervention: 20-mg LY3009104 dose administered orally once.~Second Intervention: Placebo tablets (matching 30-mg LY3009104) administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
764833|NCT01536951|P2|Participant Flow|Part A: 20 mg LY3009104, 30 mg LY3009104, Placebo|"First Intervention: 20-mg LY3009104 dose administered orally once.~Second Intervention: 30-mg LY3009104 dose administered orally once.~Third Intervention: Placebo tablets (matching 40-mg LY3009104) administered orally once.~There was a washout of at least 3 days between each intervention."
764834|NCT01536951|P1|Participant Flow|Part A: Placebo, 30 mg LY3009104, 40 mg LY3009104|"First Intervention: Placebo tablets [matching 20-mg LY3009104] administered orally once.~Second Intervention: 30-mg LY3009104 dose administered orally once.~Third Intervention: 40-mg LY3009104 dose administered orally once.~There was a washout of at least 3 days between each intervention."
764835|NCT01536951|O7|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
764836|NCT01536951|O6|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
764837|NCT01536951|O5|Outcome|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
764838|NCT01536951|O4|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
764839|NCT01536951|O3|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
764840|NCT01536951|O2|Outcome|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
764841|NCT01536951|O1|Outcome|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
764842|NCT01536951|O4|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
764843|NCT01536951|O3|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
764844|NCT01536951|O2|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
764845|NCT01536951|O1|Outcome|Part A: 20 mg LY3009104|A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
764846|NCT01536951|O4|Outcome|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
764847|NCT01536951|O3|Outcome|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
764848|NCT01536951|O2|Outcome|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
764849|NCT01536951|O1|Outcome|Part A: 20 mg LY3009104|A 20-milligram (mg) LY3009104 dose administered orally once in Part A, Period 1 of the study.
764850|NCT01536951|O3|Outcome|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
764851|NCT01536951|O2|Outcome|Part B: 40 mg LY3009104|A 40-milligram (mg) dose of LY3009104 administered orally once in any period during Part B of the study.
764852|NCT01536951|O1|Outcome|Part B: Placebo|Placebo tablets (matching LY3009104) administered orally once in any period during Part B of the study.
764853|NCT01536951|E7|Reported Event|Part B: Moxifloxacin|A single 400-mg moxifloxacin tablet administered orally once in any period during Part B of the study.
764854|NCT01536951|E6|Reported Event|Part B: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in any period during Part B of the study.
764855|NCT01536951|E5|Reported Event|Part B: Placebo|Placebo tablets (matching 40-mg LY3009104) administered orally once in any period during Part B of the study.
764856|NCT01536951|E4|Reported Event|Part A: 40 mg LY3009104|A 40-mg LY3009104 dose administered orally once in Part A, Period 3 of the study.
764857|NCT01536951|E3|Reported Event|Part A: 30 mg LY3009104|A 30-mg LY3009104 dose administered orally once in Part A, Period 2 of the study.
764858|NCT01536951|E2|Reported Event|Part A: 20 mg LY3009104|A 20-mg LY3009104 dose administered orally once in Part A, Period 1 of the study.
764859|NCT01536951|E1|Reported Event|Part A: Placebo|Placebo tablets [matching 20-milligrams (mg), 30-mg, or 40-mg LY3009104] administered orally once in any period during Part A of the study.
764860|NCT01536938|B4|Baseline|Total|Total of all reporting groups
764861|NCT01536938|B3|Baseline|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
764862|NCT01536938|B2|Baseline|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
764863|NCT01536938|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
764864|NCT01536938|P3|Participant Flow|Calcipotriol Aerosol Foam|"Calcipotriol aerosol foam: calcipotriol 50 mcg/g.~Applied once daily for up to 4 weeks"
764865|NCT01536938|P2|Participant Flow|Betamethasone Dipropionate|"Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
764866|NCT01536938|P1|Participant Flow|LEO 90100|"LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~Applied once daily for up to 4 weeks"
764867|NCT01536938|O3|Outcome|Calcipotriol Aerosol Foam|Calcipotriol aerosol foam: calcipotriol 50 mcg/g. Applied once daily for up to 4 weeks
764868|NCT01536938|O2|Outcome|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
764869|NCT01536938|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
764870|NCT01536938|E3|Reported Event|Calcipotriol Aerosol Foam|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
764871|NCT01536938|E2|Reported Event|Betamethasone Dipropionate|Betamethasone dipropionate aerosol foam: betamethasone 0.5 mg/g (as dipropionate) Applied once daily for up to 4 weeks
764873|NCT01536886|B5|Baseline|Total|Total of all reporting groups
764877|NCT01536886|B1|Baseline|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
764878|NCT01536886|P4|Participant Flow|Ointment Vehicle|Ointment with no active ingredients
764879|NCT01536886|P3|Participant Flow|LEO 90100 Vehicle|Aerosol foam with no active ingredients
764880|NCT01536886|P2|Participant Flow|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
764881|NCT01536886|P1|Participant Flow|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
764882|NCT01536886|O4|Outcome|Ointment Vehicle|Ointment with no active ingredients
764883|NCT01536886|O3|Outcome|LEO 90100 Vehicle|Aerosol foam with no active ingredients
764884|NCT01536886|O2|Outcome|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
764885|NCT01536886|O1|Outcome|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
764886|NCT01536886|E4|Reported Event|Ointment Vehicle|Ointment with no active ingredients
764887|NCT01536886|E3|Reported Event|LEO 90100 Vehicle|Aerosol foam with no active ingredients
764888|NCT01536886|E2|Reported Event|Calcipotriol Plus BDP Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) ointment
764889|NCT01536886|E1|Reported Event|LEO 90100|LEO 90100 aerosol foam: calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)
764890|NCT01536860|B1|Baseline|Entire Study Population|Includes groups randomized to receive Control Test Drink first, Exp Test Drink 1 first and Exp Test Drink 2 first.
764891|NCT01536860|P3|Participant Flow|Exp Test Drink 2/Control Test Drink/ Exp Test Drink 1|"Consume Exp Test Drink 2 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 once over a 15 minute period."
764892|NCT01536860|P2|Participant Flow|Exp Test Drink 1/Control Test Drink/Exp Test Drink 2|"Consume Exp Test Drink 1 once over a 15 minute period followed by a 3 day wash out period.~Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 2 once over a 15 minute period."
764927|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764893|NCT01536860|P1|Participant Flow|Control Test Drink/Exp Test Drink 1/Exp Test Drink 2|"Consume Control Test Drink once over a 15 minute period followed by a 3 day wash out period.~Consume Exp Test Drink 1 followed by a 3 day wash out period. Consume Exp Test Drink 2 over a 15 minute period"
764894|NCT01536860|O3|Outcome|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
764895|NCT01536860|O2|Outcome|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
764896|NCT01536860|O1|Outcome|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
764897|NCT01536860|E3|Reported Event|Experimental Test Drink 2|"Control Drink containing ingredient 2~Dietary Intervention : 300 ml of liquid food product"
764898|NCT01536860|E2|Reported Event|Experimental Test Drink 1|"Control Drink containing ingredient 1~Dietary Intervention : 300 ml of liquid food product"
764899|NCT01536860|E1|Reported Event|Control Test Drink|"Control Drink~Dietary Intervention : 300 ml of liquid food product"
764900|NCT01536704|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures
764901|NCT01536704|P4|Participant Flow|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764902|NCT01536704|P3|Participant Flow|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764903|NCT01536704|P2|Participant Flow|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764904|NCT01536704|P1|Participant Flow|2 Milligram (mg) Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764905|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764906|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764907|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764908|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764909|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764910|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764911|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764912|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764913|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764914|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764915|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764916|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764917|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764918|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764919|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764920|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764921|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764922|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764923|NCT01536704|O2|Outcome|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764924|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764925|NCT01536704|O4|Outcome|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764926|NCT01536704|O3|Outcome|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764928|NCT01536704|O1|Outcome|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764929|NCT01536704|E4|Reported Event|4mg Mint Lozenge|Participants were instructed to move the 4mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764930|NCT01536704|E3|Reported Event|4mg Cherry Lozenge|Participants were instructed to move the 4mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge
764931|NCT01536704|E2|Reported Event|2mg Mint Lozenge|Participants were instructed to move the 2mg Mint (peppermint) mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764932|NCT01536704|E1|Reported Event|2mg Cherry Lozenge|Participants were instructed to move the 2mg Cherry mini nicotine lozenge from one side of the mouth to the other periodically and not to swallow or chew the lozenge.
764933|NCT01536587|B1|Baseline|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764934|NCT01536587|P1|Participant Flow|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764935|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764936|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764937|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764938|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764939|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764940|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764941|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764942|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764943|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764944|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764945|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764946|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764947|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764948|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764949|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764950|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764951|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
766560|NCT01530243|B2|Baseline|Terazosin|Terazosine: 2 mg BID
764952|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764953|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764954|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764955|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764956|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764957|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764958|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764959|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764960|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764961|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764962|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764963|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764964|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764965|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764966|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
814924|NCT01344460|O2|Outcome|Unenhanced MRA|
764967|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764968|NCT01536587|O1|Outcome|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764969|NCT01536587|E1|Reported Event|Salmeterol 50 µg BID|Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
764970|NCT01536574|B3|Baseline|Total|Total of all reporting groups
764971|NCT01536574|B2|Baseline|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764972|NCT01536574|B1|Baseline|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764973|NCT01536574|P2|Participant Flow|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764974|NCT01536574|P1|Participant Flow|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
765094|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765095|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765096|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
764975|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764976|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764977|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
765067|NCT01536405|B2|Baseline|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
764978|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764979|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764980|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764981|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764982|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
765097|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765098|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765435|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
764983|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764984|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764985|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764986|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764987|NCT01536574|O2|Outcome|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764988|NCT01536574|O1|Outcome|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764989|NCT01536574|E2|Reported Event|Placebo in Parent DB Study, Ropinirole PR in OL Study|Participants who had received placebo in the parent DB study received ropinirole PR in this OL extension study. Participants started on ropinirole PR 2 mg for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation, or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
764990|NCT01536574|E1|Reported Event|Ropinirole PR in Parent DB Study, Ropinirole PR in OL Study|Participants who had received ropinirole PR in the parent double-blind (DB) study received ropinirole PR in this open-label (OL) extension study. Participants started on ropinirole PR 2 milligrams (mg) for 1 week. The dose was uptitrated weekly by 2 mg for the first 3 weeks. Later, the investigators could use their clinical judgment to increase the dose level above 8 mg once daily, in 4 mg increments, up to 24 mg once daily. Participants could remain on the same dose level if tolerability issues occurred during escalation or could reduce their dose by one dose level. After the 24-week treatment phase, all participants were down-titrated over the course of 1 week, or had an early withdraw visit if they did not complete the study for any reason. Participants returned for a follow-up visit 4-14 days after the last dose of ropinirole PR.
765099|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765100|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765522|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
764991|NCT01536561|B1|Baseline|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
764992|NCT01536561|P1|Participant Flow|TST and Iodine I 131 TST|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765068|NCT01536405|B1|Baseline|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765069|NCT01536405|P2|Participant Flow|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765070|NCT01536405|P1|Participant Flow|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
764993|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
764994|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
764995|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
764996|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
764997|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765101|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765102|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765103|NCT01536405|E2|Reported Event|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
764998|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765006|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
764999|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765000|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765001|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765002|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765003|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765004|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765104|NCT01536405|E1|Reported Event|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765105|NCT01536379|B3|Baseline|Total|Total of all reporting groups
765201|NCT01536262|P3|Participant Flow|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765005|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765007|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765008|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765009|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765010|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765011|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765106|NCT01536379|B2|Baseline|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765207|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765012|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765013|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765014|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765015|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765016|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765017|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765018|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765107|NCT01536379|B1|Baseline|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765523|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
765019|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765020|NCT01536561|O2|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU stu"
765021|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765022|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765023|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765024|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765025|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:>=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
765108|NCT01536379|P2|Participant Flow|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765524|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
765026|NCT01536561|O1|Outcome|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765027|NCT01536561|E2|Reported Event|TST and Iodine I 131 TST: Retreatment|"After the Initial Treatment (DD of TST and Iodine I 131 TST, followed by TD), participants who achieved a partial response (PR:&gt;=50% reduction in the sum of the products of the longest perpendicular diameters of all measurable lesions; no new lesions) or complete response (CR: complete resolution of all disease-related radiological abnormalities and the disappearance of all signs and symptoms related to the disease) and subsequently developed progressive disease were retreated at the time of disease progression. Retreatment was administered either at the initial TD of TST/I 131 TST or at a reduced dose if a Grade 2 or greater toxicity had occurred after the Initial Treatment. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the LTFU study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study."
765028|NCT01536561|E1|Reported Event|TST and Iodine I 131 TST: Initial Treatment|Participants received 1 to 3 dosimetric doses (DD) consisting of 0, 95, or 475 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine (I 131) TST IV. This was followed by a therapeutic dose (TD) administered 7-14 days after the DD, starting at a total body dose (TBD) of 25 centiGray (cGy) or 65 cGy (only for participants who had undergone bone marrow transplantation) with increments of 10 cGy at each dose level (DL) until the maximum tolerated dose (MTD) was achieved. Participants were re-dosed with a second TD when their tumor stopped regressing (was no longer shrinking). Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
765029|NCT01536496|B3|Baseline|Total|Total of all reporting groups
765030|NCT01536496|B2|Baseline|Test (r-TEG)|
765031|NCT01536496|B1|Baseline|Control (INR, PTT, Fibrinogen, D-dimer)|
765032|NCT01536496|P2|Participant Flow|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765033|NCT01536496|P1|Participant Flow|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765034|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765035|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765202|NCT01536262|P2|Participant Flow|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
766561|NCT01530243|B1|Baseline|Placebo|Placebo: same as tolterodine and terazosin dose
765036|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765037|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765038|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765039|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765040|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765041|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765042|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765109|NCT01536379|P1|Participant Flow|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765203|NCT01536262|P1|Participant Flow|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
766565|NCT01530243|P1|Participant Flow|Placebo|Placebo: same as tolterodine and terazosin dose
765043|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765044|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765045|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765046|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765047|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765048|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765049|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765110|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765204|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
777584|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
765050|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765051|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765052|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765053|NCT01536496|O1|Outcome|Control (INR, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765054|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765055|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765056|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765111|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765205|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
766566|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
765057|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765058|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765059|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765060|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765061|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765062|NCT01536496|O2|Outcome|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765063|NCT01536496|O1|Outcome|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765112|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765206|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
766567|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
765064|NCT01536496|E2|Reported Event|Test (r-TEG)|"Patients randomized to the r-TEG guided haemostatic resuscitation group (Test Group) will receive blood component therapy per usual clinical practice. The test arm involves the use of rapid-TEG to diagnose and describe post-injury coagulopathy and to guide blood product replacement per institutional algorithm. In the Test Group, blood for r-TEG will be collected on admission, or upon entering the operating room, depending on the acuity of the injury (Baseline), and this will be followed by two additional r-TEG analyses during the first six hours at the discretion of the treating team (attending surgeon, anesthesiologist) and then two further r-TEG analyses at 12 hours and at 24 hours post-injury respectively. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on rapid thrombelastography (r-TEG) results.:"
765065|NCT01536496|E1|Reported Event|Control (INR, PTT, Fibrinogen, D-dimer)|"Patients randomized to the Control Group will receive blood component therapy guided by conventional coagulation tests per usual clinical practice. The control arm involves the use of conventional coagulation tests (aPTT, INR, fibrinogen level, D-dimer) to diagnose and describe post-injury coagulopathy and to guide blood product replacement. In the Control Group, blood will be drawn for conventional coagulation testing (aPTT, INR, platelet count, fibrinogen level, D-dimer) at Baseline (as defined above), then twice more during the first six hours at the discretion of the treating team, then again at 12 hours and at 24 hours post-injury. The current institutional massive transfusion protocol will be followed. Only the results pertinent to the group to which randomized will be released to the treating team, unless otherwise requested.~Blood product transfusion based on conventional coagulation tests.: Transfusion of blood products."
765071|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765072|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765073|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765074|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765075|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765076|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765077|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765078|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765079|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765080|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765081|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765082|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765083|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765084|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765085|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765086|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765087|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765088|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765089|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765090|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765091|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
765092|NCT01536405|O1|Outcome|MMRV (AMP)|Participants were to received two 0.5 mL subcutaneous injections of Mumps, Measles, Rubella, Varicella (MMRV) vaccine made with an alternative manufacturing process (AMP)
765093|NCT01536405|O2|Outcome|MMRV (2006 Process)|Participants were to receive two 0.5 mL subcutaneous injections of MMRV made with the 2006 manufacturing process
766568|NCT01530243|O2|Outcome|Terazosin|Terazosin: 2 mg BID
765113|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765114|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765115|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765116|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765117|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765118|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765119|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765552|NCT01535365|E1|Reported Event|Heat|Application of Heat to site of muscle sprain.
765120|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765121|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765122|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765123|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765124|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765125|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765126|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765127|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765128|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765129|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765130|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765131|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
766569|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
765132|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765133|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765134|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765135|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765136|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765137|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765157|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765138|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765139|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765140|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765141|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765142|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765143|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765144|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765145|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765146|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765147|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765148|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765149|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765150|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765151|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765152|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765153|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765154|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765155|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765156|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765158|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765159|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765160|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765161|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765162|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765163|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765164|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765165|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765166|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765167|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765168|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765169|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
766570|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
765170|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765171|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765172|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765173|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765174|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765175|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765220|NCT01536197|P1|Participant Flow|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
765221|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
765176|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765177|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765178|NCT01536379|O2|Outcome|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765179|NCT01536379|O1|Outcome|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765180|NCT01536379|E2|Reported Event|Belimumab 10mg/kg|Participants received 10 milligram (mg) /kilogram (kg) belimumab in 250 milliliter (mL) normal saline via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765181|NCT01536379|E1|Reported Event|Placebo|Participants received normal saline (0.9% sodium chloride) via intravenous infusion over 1 hour, every 4 weeks for 24 weeks (with an additional dose at week 2) in addition to standard of care assessments, treatment and other interventions according to institutional protocols from the time of transplantation throughout the study.
765182|NCT01536366|B3|Baseline|Total|Total of all reporting groups
765183|NCT01536366|B2|Baseline|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
765184|NCT01536366|B1|Baseline|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
765185|NCT01536366|P2|Participant Flow|Group 2|"Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
765186|NCT01536366|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide~BIA 9-1067: 25 mg BIA 9-1067 (single-dose)~Repaglinide: 0.5 mg repaglinide (single-dose)"
765187|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
765188|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
765189|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
765190|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
765191|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
765192|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
765193|NCT01536366|O2|Outcome|Repaglinide|Repaglinide 0.5 mg
765194|NCT01536366|O1|Outcome|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
765195|NCT01536366|E2|Reported Event|Repaglinide|Repaglinide 0.5 mg
765196|NCT01536366|E1|Reported Event|BIA 9-1067 + Repaglinide|BIA 9-1067 25 mg Repaglinide 0.5 mg
765197|NCT01536262|B4|Baseline|Total|Total of all reporting groups
765198|NCT01536262|B3|Baseline|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765199|NCT01536262|B2|Baseline|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765200|NCT01536262|B1|Baseline|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765335|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765208|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765209|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765210|NCT01536262|O3|Outcome|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765211|NCT01536262|O2|Outcome|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765212|NCT01536262|O1|Outcome|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765213|NCT01536262|E3|Reported Event|Tiotropium + Olodaterol (5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765214|NCT01536262|E2|Reported Event|Tiotropium + Olodaterol (2.5 / 5 μg)|Tiotropium and Olodaterol FDC solution for inhalation - RESPIMAT : 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765215|NCT01536262|E1|Reported Event|Olodaterol (5 μg)|Olodaterol solution for inhalation - RESPIMAT: 2 Oral inhalation once daily in the morning up to 52-week treatment period.
765216|NCT01536197|B3|Baseline|Total|Total of all reporting groups
765217|NCT01536197|B2|Baseline|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
765218|NCT01536197|B1|Baseline|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
765219|NCT01536197|P2|Participant Flow|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
765222|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
765223|NCT01536197|O2|Outcome|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
765224|NCT01536197|O1|Outcome|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
765225|NCT01536197|E2|Reported Event|Gastric Banding|"morbidly obese subjects undergoing laparoscopic gastric banding surgery~Gastric banding: Laparoscopic adjustable gastric banding"
765226|NCT01536197|E1|Reported Event|Gastric Bypass|"morbidly obese subjects undergoing gastric bypass surgery~Gastric bypass: Roux-en-Y gastric bypass"
765227|NCT01536184|B3|Baseline|Total|Total of all reporting groups
765228|NCT01536184|B2|Baseline|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765229|NCT01536184|B1|Baseline|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765230|NCT01536184|P2|Participant Flow|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765231|NCT01536184|P1|Participant Flow|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765232|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765233|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765525|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
765234|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765235|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765236|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765237|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765238|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765239|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765240|NCT01536184|O2|Outcome|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765241|NCT01536184|O1|Outcome|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765242|NCT01536184|E2|Reported Event|Control Group-Regular FASD Services|Regular FASD Services include general information on Fetal Alcohol Spectrum Disorder (FASD) with general behavioural management strategies and parental supports.
765243|NCT01536184|E1|Reported Event|Receives COS Intervention|"Circle of Security (COS) Family Intervention (B. Marvin model) is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour. The protocol itself involves a series of activities and repeated videotaped interactions between the child and their caregiver which are reviewed by the therapist who has established themselves with the caregiver as a secure base from which the attachment relationship may be explored.~Circle of Security (COS): COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment"
765244|NCT01536171|B1|Baseline|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
765245|NCT01536171|P1|Participant Flow|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
765246|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|two running conditions, with normal running shoes and barefoot
765247|NCT01536171|O1|Outcome|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
765248|NCT01536171|E1|Reported Event|Mid-Forefoot Striking in Shod Versus Barefoot Runners|trained runners (men,women) with a FM strike (verified in the lab)
765249|NCT01536145|B1|Baseline|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765250|NCT01536145|P11|Participant Flow|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765251|NCT01536145|P10|Participant Flow|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765252|NCT01536145|P9|Participant Flow|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765253|NCT01536145|P8|Participant Flow|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765254|NCT01536145|P7|Participant Flow|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765255|NCT01536145|P6|Participant Flow|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765256|NCT01536145|P5|Participant Flow|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765257|NCT01536145|P4|Participant Flow|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765258|NCT01536145|P3|Participant Flow|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765259|NCT01536145|P2|Participant Flow|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765553|NCT01535326|B4|Baseline|Total|Total of all reporting groups
765260|NCT01536145|P1|Participant Flow|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765261|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765262|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765263|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765264|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765265|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765266|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765267|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765268|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765269|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765270|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765271|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765272|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765273|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765274|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765275|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765276|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765277|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765278|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765279|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765280|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765281|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765282|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765283|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765284|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765285|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765286|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765287|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765288|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765289|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765290|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765291|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765292|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765293|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765294|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765295|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765296|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765297|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765298|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765299|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765300|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765301|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765302|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765303|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765304|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765305|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765526|NCT01535599|O1|Outcome|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
765306|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765307|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765308|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765309|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765310|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765311|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765312|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765313|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765314|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765315|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765448|NCT01535976|E1|Reported Event|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
765316|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765317|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765318|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765319|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765320|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765321|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765322|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765323|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765324|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765325|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765326|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765327|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765328|NCT01536145|O7|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765329|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765330|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765331|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765332|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765333|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765334|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
766571|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
765336|NCT01536145|O6|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765337|NCT01536145|O5|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765338|NCT01536145|O4|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765339|NCT01536145|O3|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765340|NCT01536145|O2|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765341|NCT01536145|O1|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765342|NCT01536145|O9|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765343|NCT01536145|O8|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765344|NCT01536145|O7|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765345|NCT01536145|O6|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765346|NCT01536145|O5|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765347|NCT01536145|O4|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765348|NCT01536145|O3|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765349|NCT01536145|O2|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765350|NCT01536145|O1|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765351|NCT01536145|O11|Outcome|CP-751,871 20 mg/kg|CP-751,871 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765352|NCT01536145|O10|Outcome|CP-751,871 10 mg/kg|CP-751,871 10 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765353|NCT01536145|O9|Outcome|CP-751,871 6 mg/kg|CP-751,871 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765354|NCT01536145|O8|Outcome|CP-751,871 3 mg/kg|CP-751,871 3 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent Cycles, starting from Cycle 2 (4 weeks)
765355|NCT01536145|O7|Outcome|CP-751,871 1.5 mg/kg|CP-751,871 1.5 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765356|NCT01536145|O6|Outcome|CP-751,871 0.8 mg/kg|CP-751,871 0.8 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765357|NCT01536145|O5|Outcome|CP-751,871 0.4 mg/kg|CP-751,871 0.4 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765358|NCT01536145|O4|Outcome|CP-751,871 0.2 mg/kg|CP-751,871 0.2 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765359|NCT01536145|O3|Outcome|CP-751,871 0.1 mg/kg|CP-751,871 0.1 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765360|NCT01536145|O2|Outcome|CP-751,871 0.05 mg/kg|CP-751,871 0.05 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765361|NCT01536145|O1|Outcome|CP-751,871 0.025 mg/kg|CP-751,871 0.025 milligram/kilogram (mg/kg) administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks)
765362|NCT01536145|O1|Outcome|CP-751,871 0.025-20 mg/kg|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks)
765396|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765527|NCT01535599|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
765363|NCT01536145|E1|Reported Event|CP-751,871|CP-751,871 0.025, 0.05, 0.1, 0.2, 0.4, 0.8, 1.5, 3 and 6 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks), and dose of 50% from the Cycle 1 dose administered on Day 1 of subsequent cycles, starting from Cycle 2 (4 weeks); CP-751,871 10 and 20 mg/kg administered intravenously on Day 1 of Cycle 1 (4 weeks or 8 weeks) and subsequent cycles, starting from Cycle 2 (4 weeks) (adverse events from all dosing groups were combined as a whole)
765364|NCT01536119|B3|Baseline|Total|Total of all reporting groups
765365|NCT01536119|B2|Baseline|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765366|NCT01536119|B1|Baseline|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765367|NCT01536119|P2|Participant Flow|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765368|NCT01536119|P1|Participant Flow|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765369|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765370|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765371|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765372|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765373|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765374|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765375|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765376|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765377|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765378|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765379|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765380|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765381|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765382|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765383|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765384|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765385|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765386|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765387|NCT01536119|O2|Outcome|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765388|NCT01536119|O1|Outcome|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765389|NCT01536119|E2|Reported Event|Usual Care Group|The usual care group will receive standard postpartum care in the hospital and in the community
765390|NCT01536119|E1|Reported Event|Coparenting Breastfeeding Support Intervention|The intervention group will receive a in-hospital discussion, a video, a workbook,a breastfeeding booklet, access to a secure study website, two follow-up emails, and one telephone call.
765391|NCT01536093|B3|Baseline|Total|Total of all reporting groups
765392|NCT01536093|B2|Baseline|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765393|NCT01536093|B1|Baseline|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765394|NCT01536093|P2|Participant Flow|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765395|NCT01536093|P1|Participant Flow|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765397|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765398|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765399|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765400|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765401|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765402|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765403|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765404|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765449|NCT01535807|B3|Baseline|Total|Total of all reporting groups
765602|NCT01535222|B2|Baseline|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
765405|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765406|NCT01536093|O2|Outcome|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765407|NCT01536093|O1|Outcome|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765408|NCT01536093|E2|Reported Event|Placebo|"oropharyngeal administration of sterile water~oropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765409|NCT01536093|E1|Reported Event|Colostrum|"oropharyngeal administration of own mother's colostrum~oropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."
765410|NCT01536067|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765411|NCT01536067|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765412|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765413|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765414|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
766572|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
765415|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765416|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765417|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765546|NCT01535365|P1|Participant Flow|Heat|Application of Heat to site of muscle sprain.
765418|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765419|NCT01536067|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765420|NCT01536067|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|"INDUCTION PHASE: Patients receive ofatumumab IV on days 1, 8, and 15 and bortezomib SC on days 8 and 15. Beginning on course 2, patients receive ofatumumab IV on days 1 and 15 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE PHASE: Beginning 8 weeks after course 4 of induction phase, patients receive ofatumumab IV on day 1 and bortezomib SC on days 1, 8, and 15. Treatment repeats every 28 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given SC~laboratory biomarker analysis: Correlative studies"
765421|NCT01536015|B3|Baseline|Total|Total of all reporting groups
765422|NCT01536015|B2|Baseline|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765423|NCT01536015|B1|Baseline|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765424|NCT01536015|P2|Participant Flow|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765425|NCT01536015|P1|Participant Flow|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765426|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765427|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765428|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765429|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765430|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765431|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765432|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765433|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765434|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765436|NCT01536015|O2|Outcome|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765437|NCT01536015|O1|Outcome|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765438|NCT01536015|E2|Reported Event|Rotigotine|"Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached.~Rotigotine: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours~Dosage and Frequency: One patch every 24 hours~Duration: 10 weeks"
765439|NCT01536015|E1|Reported Event|Placebo|"Placebo patch~Placebo: Frequency: One patch applied every 24 hours~Duration: 10 weeks"
765440|NCT01535976|B3|Baseline|Total|Total of all reporting groups
765441|NCT01535976|B2|Baseline|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
765442|NCT01535976|B1|Baseline|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min"
765443|NCT01535976|P2|Participant Flow|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
765444|NCT01535976|P1|Participant Flow|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case"
765445|NCT01535976|O2|Outcome|Placebo|"normal saline infusion~Placebo : Placebo Comparator: Placebo~normal saline infusion along with propofol 100 mcg/kg/min"
765446|NCT01535976|O1|Outcome|Ketamine|"Infusion of ketamine~Ketamine : Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case along with propofol 100 mcg/kg/min."
765447|NCT01535976|E2|Reported Event|Placebo|".9 normal saline infusion~Placebo : Placebo Comparator: Placebo~.9 normal saline infusion"
765450|NCT01535807|B2|Baseline|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765451|NCT01535807|B1|Baseline|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765452|NCT01535807|P2|Participant Flow|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765453|NCT01535807|P1|Participant Flow|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765454|NCT01535807|O2|Outcome|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765455|NCT01535807|O1|Outcome|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765456|NCT01535807|E2|Reported Event|Control|"The control No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765457|NCT01535807|E1|Reported Event|CorMatrix Group|"The treatment Cormatrix group will receive the CorMatrix EMC during surgery for the closure of the pericardium according to the specific recommended surgical technique.~CorMatrix extra cellular matrix (ECM): - Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.~- No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
765458|NCT01535729|B1|Baseline|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765459|NCT01535729|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC) Elderly Participants|Elderly Participants (greater than or equal to [≥] 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765460|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765461|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765462|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765463|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765528|NCT01535599|E1|Reported Event|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
765529|NCT01535560|B3|Baseline|Total|Total of all reporting groups
765464|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765465|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765466|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765467|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765468|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765469|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765470|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765471|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765547|NCT01535365|O2|Outcome|Cold|Application of cold to muscle sprain.
765548|NCT01535365|O1|Outcome|Heat|Application of heat to site of muscle sprain.
765472|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765473|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765474|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765475|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765476|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765477|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765478|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765479|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765480|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765481|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765482|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765483|NCT01535729|O1|Outcome|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765484|NCT01535729|E1|Reported Event|NSCLC Elderly Participants|Elderly Participants (≥ 65 years) with locally advanced or metastatic NSCLC, on erlotinib (Tarceva®) prescribed in accordance with the terms of the marketing authorization, were observed for maximum of 12 months.
765485|NCT01535664|B1|Baseline|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765486|NCT01535664|P1|Participant Flow|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765487|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765488|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
765489|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765490|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
765491|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765492|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
765493|NCT01535664|O2|Outcome|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765494|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|
765495|NCT01535664|O2|Outcome|Dalfampridine-ER 10 mg|
765496|NCT01535664|O1|Outcome|Dalfampridine-ER Withdrawn|"Subjects with MS taking dalfampridine-ER 10mg and considered to be responders~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765497|NCT01535664|E2|Reported Event|Dalfampridine-ER Withdrawn|
765498|NCT01535664|E1|Reported Event|Dalfampridine-ER 10mg|"Subjects with MS taking dalfampridine-ER 10mg~Withdrawal of dalfampridine-ER 10mg : Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)"
765499|NCT01535638|B1|Baseline|All Subjects|This study was conducted in healthy male subjects as open-label, single-dose, randomised three-way crossover trial to investigate relative bioavailability. Each subject was planned to receive all 3 treatments in a randomly assigned order. The treatments were 3 single doses of 600 mg (3 film-coated tablets à 200 mg each) of Deleobuvir, either as TF II (trial formulation 2) formulation, FF (final formulation) formulation or as FF modified formulation.
765549|NCT01535365|O2|Outcome|Ice Pack|Application of cold to muscle sprain.
765550|NCT01535365|O1|Outcome|Heat Pack|Application of Heat to site of muscle sprain.
765500|NCT01535638|P6|Participant Flow|Final Formulation (FF) Modified / FF / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Final Formulation and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
765501|NCT01535638|P5|Participant Flow|Final Formulation (FF) Modified / Trial Formulation II / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation modified, Trial Formulation II and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
765502|NCT01535638|P4|Participant Flow|Final Formulation (FF) / FF Modified / Trial Formulation II|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Final Formulation modified and Trial Formulation II. There was a wash out period of at least 6 days between each drug administration.
765503|NCT01535638|P3|Participant Flow|Final Formulation (FF) / Trial Formulation II / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Final Formulation, Trial Formulation II and Final Formulation modified. There was a wash out period of at least 6 days between each drug administration.
765504|NCT01535638|P2|Participant Flow|Trial Formulation II / Final Formulation (FF) Modified / FF|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation II, Final Formulation modified and Final Formulation. There was a wash out period of at least 6 days between each drug administration.
765505|NCT01535638|P1|Participant Flow|Trial Formulation II / Final Formulation (FF) / FF Modified|In this sequence group the treatments (600 mg Deleobuvir in different formulations, single dose) are administered in the order Trial Formulation (TF) II, Final Formulation (FF) and FF modified. There was a wash out period of at least 6 days between each drug administration.
765506|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765507|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765508|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765509|NCT01535638|O3|Outcome|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765510|NCT01535638|O2|Outcome|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765511|NCT01535638|O1|Outcome|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765512|NCT01535638|E4|Reported Event|Deleobuvir (Total)|All subjects while on treatment with Deleobuvir, i.e. there is no distinction between the 3 formulations.
765513|NCT01535638|E3|Reported Event|Deleobuvir Final Formulation Modified|"Final formulation modified film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765514|NCT01535638|E2|Reported Event|Deleobuvir Final Formulation|"Final formulation film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765515|NCT01535638|E1|Reported Event|Deleobuvir Trial Formulation II|"Trial formulation II film-coated tablets.~600 mg Deleobuvir (3 tablets à 200 mg). Oral administration with 240 mL water directly after a standard normal breakfast."
765516|NCT01535599|B3|Baseline|Total|Total of all reporting groups
765517|NCT01535599|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
765518|NCT01535599|B1|Baseline|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
765519|NCT01535599|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
765520|NCT01535599|P1|Participant Flow|AL-60371|AL-60371, 0.3% Otic Suspension, 4 drops to the affected ear(s) twice daily for 7 days
765521|NCT01535599|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops to the affected ear(s) twice daily for 7 days
765530|NCT01535560|B2|Baseline|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
765531|NCT01535560|B1|Baseline|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
765532|NCT01535560|P2|Participant Flow|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
765533|NCT01535560|P1|Participant Flow|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
765534|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
765535|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
765536|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
765537|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
765538|NCT01535560|O2|Outcome|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
765539|NCT01535560|O1|Outcome|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
765540|NCT01535560|E2|Reported Event|Vehicle|AL-60371 Vehicle, 4 drops in the affected ear(s) twice daily for 7 days
765541|NCT01535560|E1|Reported Event|AL-60371|AL-60371, 0.3% otic suspension, 4 drops in the affected ear(s) twice daily for 7 days
765542|NCT01535365|B3|Baseline|Total|Total of all reporting groups
765543|NCT01535365|B2|Baseline|Cold|Application of cold to muscle sprain.
765544|NCT01535365|B1|Baseline|Heat|Application of Heat to site of muscle sprain.
765545|NCT01535365|P2|Participant Flow|Cold|Application of cold to muscle sprain.
765554|NCT01535326|B3|Baseline|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
765555|NCT01535326|B2|Baseline|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
765556|NCT01535326|B1|Baseline|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
765557|NCT01535326|P3|Participant Flow|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
765558|NCT01535326|P2|Participant Flow|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
765559|NCT01535326|P1|Participant Flow|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
765560|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
765561|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
765562|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
765563|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
765564|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
765565|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
765566|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
765567|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
765568|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
765569|NCT01535326|O3|Outcome|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy~Proportion of no pain: 61.1%"
765570|NCT01535326|O2|Outcome|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal~Proportion of no pain: 43.3%"
765571|NCT01535326|O1|Outcome|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy~Proportion of no pain: 30%"
765572|NCT01535326|E3|Reported Event|Water Exchange|"infuse and remove water during insertion phase of colonoscopy~water exchange: infuse and remove water during insertion phase of colonoscopy"
765573|NCT01535326|E2|Reported Event|Water Immersion|"infuse water during insertion, remove water during withdrawal of colonoscopy~water immersion: infuse water during insertion, aspirate water during withdrawal"
765574|NCT01535326|E1|Reported Event|Air Insufflation|"Use air insufflation during colonoscopy~air insufflation: insufflate air during the insertion of colonoscopy"
765575|NCT01535261|B1|Baseline|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765576|NCT01535261|P1|Participant Flow|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765577|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765578|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765579|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765580|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765581|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765582|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765583|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765584|NCT01535261|O1|Outcome|Ranibizumab Arm|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765585|NCT01535261|E1|Reported Event|Ranibizumab 0.5mg|Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
765586|NCT01535235|B3|Baseline|Total|Total of all reporting groups
765587|NCT01535235|B2|Baseline|Placebo|"Placebo group~Placebo: Placebo Daily x24wks"
765588|NCT01535235|B1|Baseline|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg Daily x 24 weeks"
765589|NCT01535235|P2|Participant Flow|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
765590|NCT01535235|P1|Participant Flow|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
765591|NCT01535235|O2|Outcome|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
765592|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
765593|NCT01535235|O2|Outcome|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
765594|NCT01535235|O1|Outcome|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
765595|NCT01535235|E2|Reported Event|Placebo|"Placebo group~Placebo: Placebo QD x24wks"
765596|NCT01535235|E1|Reported Event|ACE Inhibitor|"Active group~Lisinopril: Lisinopril 20mg QD x 24 weeks"
765597|NCT01535222|B7|Baseline|Total|Total of all reporting groups
765598|NCT01535222|B6|Baseline|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
765599|NCT01535222|B5|Baseline|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
765600|NCT01535222|B4|Baseline|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
765601|NCT01535222|B3|Baseline|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
765603|NCT01535222|B1|Baseline|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
765604|NCT01535222|P6|Participant Flow|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
765605|NCT01535222|P5|Participant Flow|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
765606|NCT01535222|P4|Participant Flow|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
765607|NCT01535222|P3|Participant Flow|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
765608|NCT01535222|P2|Participant Flow|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
765609|NCT01535222|P1|Participant Flow|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
765610|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
765611|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
765612|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
765613|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
765614|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
765615|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
765616|NCT01535222|O6|Outcome|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
765617|NCT01535222|O5|Outcome|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
765618|NCT01535222|O4|Outcome|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
765619|NCT01535222|O3|Outcome|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
765620|NCT01535222|O2|Outcome|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
765621|NCT01535222|O1|Outcome|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
765622|NCT01535222|E6|Reported Event|Placebo|commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion
765623|NCT01535222|E5|Reported Event|Cohort 5|loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg
765624|NCT01535222|E4|Reported Event|Cohort 4|loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg
765625|NCT01535222|E3|Reported Event|Cohort 3|loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg
765626|NCT01535222|E2|Reported Event|Cohort 2|loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg
765627|NCT01535222|E1|Reported Event|Cohort 1|loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg
765628|NCT01535118|B1|Baseline|Adults and Children With ARC|Adults and children with ARC who complete the survey
765629|NCT01535118|P1|Participant Flow|Adults and Children With Allergic Rhinoconjunctivitis (ARC)|Adults and children with ARC who complete the survey
765630|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
765631|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
765632|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
765633|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
765634|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
765635|NCT01535118|O1|Outcome|Adults and Children With ARC|Adults and children with ARC who complete the survey
777585|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
765636|NCT01535118|E1|Reported Event|Adults and Children With ARC|Adults and children with ARC who complete the survey
765637|NCT01535040|B3|Baseline|Total|Total of all reporting groups
765638|NCT01535040|B2|Baseline|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
765639|NCT01535040|B1|Baseline|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
765640|NCT01535040|P2|Participant Flow|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
765641|NCT01535040|P1|Participant Flow|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
765642|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
765643|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
765644|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
765645|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
765646|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
765713|NCT01534962|E1|Reported Event|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765714|NCT01534910|B3|Baseline|Total|Total of all reporting groups
765647|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
765648|NCT01535040|O2|Outcome|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
765649|NCT01535040|O1|Outcome|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
765650|NCT01535040|E2|Reported Event|Arm II - Placebo|"Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity.~placebo: Placebo by mouth through completion of 12 weeks."
765651|NCT01535040|E1|Reported Event|Arm I - Memantine|"Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity.~memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks."
765652|NCT01535001|B3|Baseline|Total|Total of all reporting groups
765653|NCT01535001|B2|Baseline|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765654|NCT01535001|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765655|NCT01535001|P2|Participant Flow|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765656|NCT01535001|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765657|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765696|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765697|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765658|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765659|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765660|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765661|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765715|NCT01534910|B2|Baseline|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract"
765716|NCT01534910|B1|Baseline|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo"
765662|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765663|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765664|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765665|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765666|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765667|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765668|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765669|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765698|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765670|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765671|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765672|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765673|NCT01535001|O2|Outcome|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765674|NCT01535001|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765675|NCT01535001|E2|Reported Event|Standard Treatment|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information: Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.~Information will be given in a leaflet."
765676|NCT01535001|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazole: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).~The participants will be advised to use the insoles in all shoes."
765677|NCT01534962|B5|Baseline|Total|Total of all reporting groups
765678|NCT01534962|B4|Baseline|Placebo|Placebo, oral, BID.
765679|NCT01534962|B3|Baseline|Ranolazin High Dose|Ranolazine, high dose, oral, BID
765680|NCT01534962|B2|Baseline|Ranolazine Intermediate Dose|Ranolazine, intermediate dose, oral, BID
765681|NCT01534962|B1|Baseline|Ranolazine Low Dose|Ranolazine, low dose, oral, BID
765682|NCT01534962|P4|Participant Flow|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765683|NCT01534962|P3|Participant Flow|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765684|NCT01534962|P2|Participant Flow|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765685|NCT01534962|P1|Participant Flow|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765686|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765687|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765688|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765689|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765690|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765691|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765692|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765693|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765694|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765695|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765780|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
765699|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765700|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765701|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765702|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765703|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765704|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765705|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765706|NCT01534962|O4|Outcome|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765707|NCT01534962|O3|Outcome|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765708|NCT01534962|O2|Outcome|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765709|NCT01534962|O1|Outcome|Ranolazine Low Dose|"Ranolazine, low dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765710|NCT01534962|E4|Reported Event|Placebo|"Placebo (sugar pill), oral, BID.~Placebo: Oral administration, BID; for a maximum of 112 days."
765711|NCT01534962|E3|Reported Event|Ranolazin High Dose|"Ranolazine, high dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765712|NCT01534962|E2|Reported Event|Ranolazine Intermediate Dose|"Ranolazine, intermediate dose, oral, BID~Ranolazine: Oral administration, BID; for a maximum of 112 days."
765717|NCT01534910|P2|Participant Flow|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day"
765719|NCT01534910|O2|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day"
765720|NCT01534910|O1|Outcome|Sugar Pill|"placebo~placebo: placebo"
765721|NCT01534910|O2|Outcome|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
765722|NCT01534910|O1|Outcome|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
765723|NCT01534910|E2|Reported Event|Aged Garlic Extract|"2400 mg of aged garlic extract~aged garlic extract: 2400 mg a day patients randomized to aged garlic extract No adverse events"
765724|NCT01534910|E1|Reported Event|Sugar Pill|"placebo~placebo: placebo patients were randomized to placebo No adverse events"
765725|NCT01534897|B1|Baseline|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
765726|NCT01534897|P1|Participant Flow|GSK2118436|"Note: This is a single arm feasibility study.~Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
765727|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
765728|NCT01534897|O1|Outcome|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
765729|NCT01534897|O1|Outcome|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
765730|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
765731|NCT01534897|O1|Outcome|GSK2118436|Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.
765732|NCT01534897|E1|Reported Event|GSK2118436|"Intervention: GSK2118436 (dabrafenib) 150mg by mouth twice per day for 28 days, continued to day 42 if the Day 25 Iodine-131 scan shows new uptake. Patients with new Iodine-131 uptake on Day 25 who continue dabrafenib to day 42 receive a treatment dose (150 mCi) of Iodine-131 on Day 37.~GSK2118436: 150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)"
765781|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
765782|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
765783|NCT01534533|E4|Reported Event|Normal Lutein Control Group|20mg lutein for subjects free from atherosclerosis, once a day
765733|NCT01534689|B1|Baseline|Erchonia FX-405™ Laser|"The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW~Erchonia FX-405™ Laser: The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time."
765734|NCT01534689|P1|Participant Flow|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
765735|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
765736|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
765737|NCT01534689|O1|Outcome|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
765804|NCT01534351|B2|Baseline|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765738|NCT01534689|E1|Reported Event|Erchonia FX-405™ Laser|The Erchonia FX-405™ Laser is a dual-diode laser emitting 15.5-17.5 milliWatts (mW) of 635 nanometer (nm) red laser light and 23.5-25.5 mW 405 nm blue laser light. The the power reaching the surface of the skin is 1 mW. The Erchonia FX-405™ Laser is activated such that the laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
765739|NCT01534676|B3|Baseline|Total|Total of all reporting groups
765740|NCT01534676|B2|Baseline|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
765741|NCT01534676|B1|Baseline|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
765742|NCT01534676|P2|Participant Flow|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
765743|NCT01534676|P1|Participant Flow|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
765744|NCT01534676|O2|Outcome|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
765745|NCT01534676|O1|Outcome|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
765746|NCT01534676|E2|Reported Event|Donors|Volunteer dedicated donors will be recruited to donate blood for each transfusion events over the next 3 years. Each patient with a chronic illness such as sickle cell disease or thalassemia will have one dedicated donor.
765747|NCT01534676|E1|Reported Event|Recipients|Participants with a blood disorder (either sickle cell disease or thalassemia) and currently receive blood transfusions as treatment - will be receiving the following transfusion according to regular schedule: a fresh blood, a stored blood, a washed blood, and a frozen blood transfusion.
765748|NCT01534637|B1|Baseline|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
765784|NCT01534533|E3|Reported Event|Combination Group|early atherosclerosis cases, received 20mg lutein plus 20mg lycopene, once a day
765785|NCT01534533|E2|Reported Event|Lutein Group|early atherosclerosis cases, received 20mg lutein, once a day
765786|NCT01534533|E1|Reported Event|Placebo|early atherosclerosis cases, received starch in hard shell gelatine capsules, once a day
765787|NCT01534520|B3|Baseline|Total|Total of all reporting groups
765788|NCT01534520|B2|Baseline|Group 2: Intravaginal Placebo Gel|4mL placebo gel (K-Y Jelly) for vaginal self-administration
766573|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
765749|NCT01534637|P1|Participant Flow|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
765750|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
765751|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
766416|NCT01532141|E4|Reported Event|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
765752|NCT01534637|O1|Outcome|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
765753|NCT01534637|E1|Reported Event|Treatment (Antiemetic, Chemotherapy, and Radiation Therapy)|"CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily on days 1-5 for 5.5 weeks. Patients also receive gemcitabine hydrochloride IV over 30 minutes once weekly and either fluorouracil IV continuously or capecitabine PO twice daily on days 1-5.~PROPHYLACTIC THERAPY: Beginning 1 hour before chemoradiotherapy, patients receive aprepitant PO on days 1-3. Treatment repeats every 7 days for 5.5 weeks in the absence of disease progression or unacceptable toxicity.~CONSOLIDATION CHEMOTHERAPY: Two to four weeks after completion of chemoradiotherapy and prophylactic therapy, patients without disease progression or a declining performance status receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity."
765754|NCT01534533|B5|Baseline|Total|Total of all reporting groups
765755|NCT01534533|B4|Baseline|Normal Lutein Group|subjects without early atherosclerosis
765756|NCT01534533|B3|Baseline|Lutein and Lycopene Group|lutein plus lycopene group
765757|NCT01534533|B2|Baseline|Lutein Group|20mg lutein per day
765758|NCT01534533|B1|Baseline|Placebo|starch in hard shell gelatine capsules
765759|NCT01534533|P4|Participant Flow|Normal Lutein Group|subjects without early atherosclerosis
765760|NCT01534533|P3|Participant Flow|Lutein and Lycopene Group|lutein plus lycopene group
765761|NCT01534533|P2|Participant Flow|Lutein Group|20mg lutein per day
765762|NCT01534533|P1|Participant Flow|Placebo|starch in hard shell gelatine capsules
765763|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
765764|NCT01534533|O3|Outcome|Combination Group (LL Group)|early atherosclerosis cases received 20mg lutein and 20mg lycopene
765765|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
765766|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
765767|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
765768|NCT01534533|O3|Outcome|Lutein and Lycopene Group (LL Group)|received 20mg lutein and 20mg lycopene
765769|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
765770|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
765771|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
765772|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
765773|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
765774|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
765775|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
765776|NCT01534533|O3|Outcome|Combination Group (LL Group)|received 20mg lutein and 20mg lycopene
765777|NCT01534533|O2|Outcome|Lutein Group (L Group)|early atherosclerosis case received 20mg lutein
765778|NCT01534533|O1|Outcome|Placebo (P Group)|starch in hard shell gelatine capsules
765779|NCT01534533|O4|Outcome|Normal Lutein Control Group (NL Group)|subjects free from atherosclerosis received 20mg lutein
765789|NCT01534520|B1|Baseline|Group 1: Intravaginal 2% Lidocaine Gel|"4mL of 2% lidocaine gel for vaginal self-administration~)"
765790|NCT01534520|P2|Participant Flow|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
765791|NCT01534520|P1|Participant Flow|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
765792|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|Intravaginal insertion of 4ml of placebo gel (K-Y Jelly)
765793|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|4 ml of 2% lidocaine gel for self vaginal insertion
765794|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Placebo: KY Jelly"
765795|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
765796|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
765797|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Placebo: KY Jelly"
765798|NCT01534520|O2|Outcome|Group 2: Intravaginal Placebo Gel|"Intravaginal insertion of 4mL of placebo gel ( K-Y Jelly)~Lidocaine: Intravaginal insertion of 5mL 2% lidocaine gel"
765799|NCT01534520|O1|Outcome|Group 1: Intravaginal 2% Lidocaine Gel|"Intravaginal insertion of 4mL of 2% lidocaine gel~Placebo: KY Jelly"
765800|NCT01534520|E2|Reported Event|Study Drug|"Intravaginal insertion of 4mL 2% lidocaine gel~Lidocaine: Intravaginal insertion of 4mL 2% lidocaine gel"
765801|NCT01534520|E1|Reported Event|Placebo|"Intravaginal insertion of 4mL placebo gel~Placebo: KY Jelly"
765802|NCT01534351|B4|Baseline|Total|Total of all reporting groups
765803|NCT01534351|B3|Baseline|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765832|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765805|NCT01534351|B1|Baseline|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765806|NCT01534351|P3|Participant Flow|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765807|NCT01534351|P2|Participant Flow|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765808|NCT01534351|P1|Participant Flow|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765809|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765810|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765811|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765812|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765813|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765814|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765815|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765816|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765817|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765818|NCT01534351|O3|Outcome|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765819|NCT01534351|O2|Outcome|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765820|NCT01534351|O1|Outcome|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765821|NCT01534351|E3|Reported Event|Finasteride and Tamsulosin|Finasteride 5 mg orally once daily and tamsulosin 0.2 mg orally once daily for 12 months, taken concomitantly. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765822|NCT01534351|E2|Reported Event|Tamsulosin|Tamsulosin 0.2 mg taken orally once daily and finasteride-matching placebo 5 mg taken orally once daily for 12 months. The tamsulosin will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765823|NCT01534351|E1|Reported Event|Finasteride|Finasteride 5 mg taken orally once daily and tamsulosin-matching placebo 0.2 mg taken orally once daily for 12 months. The tamsulosin-matching placebo will be taken approximately one half hour following the same meal each day. Medications may be taken separately or together.
765824|NCT01534208|B3|Baseline|Total|Total of all reporting groups
765825|NCT01534208|B2|Baseline|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765826|NCT01534208|B1|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765827|NCT01534208|P2|Participant Flow|Androxal 25 mg|"Androxal 25 mg daily~Androxal, oral, 25 mg capsule, taken once daily"
765828|NCT01534208|P1|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal, oral, 12.5 mg capsule, taken once daily"
765829|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765830|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765831|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
766417|NCT01532141|E3|Reported Event|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
765833|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765834|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765835|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765836|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765837|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765838|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765839|NCT01534208|O2|Outcome|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765840|NCT01534208|O1|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765841|NCT01534208|E2|Reported Event|Androxal 25 mg|"Androxal 25 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765842|NCT01534208|E1|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg daily~Androxal: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated"
765843|NCT01534182|B3|Baseline|Total|Total of all reporting groups
765844|NCT01534182|B2|Baseline|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
765845|NCT01534182|B1|Baseline|Fingolimod|Participants received 0.5 mg orally once a day.
765846|NCT01534182|P2|Participant Flow|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
765847|NCT01534182|P1|Participant Flow|Fingolimod|Participants received 0.5 mg orally once a day.
765848|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
765849|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
765850|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
765851|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
765852|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
765853|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
765854|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
765855|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
765856|NCT01534182|O2|Outcome|Standard Disease Modifying Therapy (DMT)|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week or glatiramer acetate (GA), 20 mg subcutaneously once a day.
765857|NCT01534182|O1|Outcome|Fingolimod|Participants received 0.5 mg orally once a day.
766574|NCT01530243|O4|Outcome|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
765858|NCT01534182|E3|Reported Event|Standard Disease Modifying Therapy: Glatiramer Acetate|Patients who received glatiramer acetate (GA), 20 mg subcutaneously once a day.
765859|NCT01534182|E2|Reported Event|Standard Disease Modifying Therapy (DMT): Interferon Beta-1a|Participants received interferon beta-1a (IFN), 44 mcg subcutaneously 3 times a week
765860|NCT01534182|E1|Reported Event|Fingolimod|Participants received 0.5 mg orally once a day.
765861|NCT01534143|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765862|NCT01534143|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765863|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765892|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765864|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765865|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765866|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765867|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765868|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765869|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765870|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
766023|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
765871|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765872|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765873|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765891|NCT01533935|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg.~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
765874|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765875|NCT01534143|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765876|NCT01534143|E1|Reported Event|Treatment (Chemotherapy, Enzyme Inhibitor)|"CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV on days -7 to -3, busulfan IV on days -6 to -3, and bortezomib IV on day -2.~GVHD PROPHYLAXIS: Patients receive thymoglobulin IV on days -3 to -1, sirolimus PO on day -3, and tacrolimus IV on day -3. Patients undergo allogeneic HSCT on day 0.~anti-thymocyte globulin : Given IV~pharmacological study : Correlative studies~fludarabine phosphate : Given IV~busulfan : Given IV~bortezomib : Given IV~allogeneic hematopoietic stem cell transplantation : Undergo allogeneic HSCT~tacrolimus : Given IV~laboratory biomarker analysis : Correlative studies~sirolimus : Given PO"
765877|NCT01533974|B3|Baseline|Total|Total of all reporting groups
765878|NCT01533974|B2|Baseline|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
765879|NCT01533974|B1|Baseline|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
765880|NCT01533974|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
765881|NCT01533974|P1|Participant Flow|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
765882|NCT01533974|O2|Outcome|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
765883|NCT01533974|O1|Outcome|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
765884|NCT01533974|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT): The control condition will be the current group-delivered CBT smoking cessation program at GH.
765885|NCT01533974|E1|Reported Event|Acceptance and Commitment Therapy (ACT)|"We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker’s ACT treatment program.~Acceptance & Commitment Therapy (ACT): We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program."
765886|NCT01533935|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were:~Oral inhalation of placebo~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
765914|NCT01533935|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
766575|NCT01530243|O3|Outcome|Tolterodine|Tolterodine: 2 mg daily
765887|NCT01533935|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
765888|NCT01533935|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
765889|NCT01533935|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
765890|NCT01533935|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered, by oral inhalation delivered once daily in the morning, via the respimat inhaler, were~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
766418|NCT01532141|E2|Reported Event|BIA 9-1067 Alone|BIA 9-1067 alone.
765893|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765894|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765895|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765896|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765897|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765898|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765899|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765900|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765901|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765902|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765903|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765904|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765905|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765906|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765907|NCT01533935|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765908|NCT01533935|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765909|NCT01533935|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765910|NCT01533935|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765911|NCT01533935|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765912|NCT01533935|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765913|NCT01533935|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765915|NCT01533935|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765916|NCT01533935|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765917|NCT01533922|B1|Baseline|Overall Study|"A randomised, double-blind, placebo controlled, 5 treatment, 4-period, incomplete, crossover study. Each treatment period was separated by a washout period of 21 days. The 5 treatments, administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Olodaterol fixed dose 5 µg~Tiotropium fixed dose 5 µg~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Treatment sequence is not considered as a factor which may affect the treatment effect due to sufficient washout period added between treatment cycles. As a result, we only display baseline characteristics as a whole population, but not by treatment sequence"
765918|NCT01533922|P5|Participant Flow|Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg"
765919|NCT01533922|P4|Participant Flow|Olo / Placebo / Tio+Olo 2.5/5 / Tio+Olo 5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg"
765920|NCT01533922|P3|Participant Flow|Tio / Olo / Placebo / Tio+Olo 2.5/5|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg"
765964|NCT01533597|B2|Baseline|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765921|NCT01533922|P2|Participant Flow|Tio+Olo 5/5 / Tio / Olo / Placebo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg~Oral inhalation of placebo"
765922|NCT01533922|P1|Participant Flow|Tio+Olo 2.5/5 / Tio+Olo 5/5 / Tio / Olo|"Patients received a total of four treatments, and each treatment period is separated by a washout period of 21 days. The treatments administered orally via the respimat inhaler, once daily, in the morning were:~Fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg~Fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg~Tiotropium fixed dose 5 µg~Olodaterol fixed dose 5 µg"
765923|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765924|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765925|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765926|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765927|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765928|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765929|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765930|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765931|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765932|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765933|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765934|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765935|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765936|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765937|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765938|NCT01533922|O5|Outcome|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765939|NCT01533922|O4|Outcome|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
766120|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
765940|NCT01533922|O3|Outcome|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765941|NCT01533922|O2|Outcome|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765942|NCT01533922|O1|Outcome|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765943|NCT01533922|E5|Reported Event|Tiotropium + Olodaterol 5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765944|NCT01533922|E4|Reported Event|Tiotropium + Olodaterol 2.5/5|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765945|NCT01533922|E3|Reported Event|Tiotropium 5 µg|Oral inhalation of Tiotropium fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765946|NCT01533922|E2|Reported Event|Olodaterol 5 µg|Oral inhalation of Olodaterol fixed dose 5 µg (2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
765947|NCT01533922|E1|Reported Event|Placebo|Oral inhalation of placebo, 2 puffs from the Respimat inhaler, once daily, in the morning.
765948|NCT01533753|B3|Baseline|Total|Total of all reporting groups
765949|NCT01533753|B2|Baseline|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
765965|NCT01533597|B1|Baseline|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
766419|NCT01532141|E1|Reported Event|Before Treatment|Before treatment.
765950|NCT01533753|B1|Baseline|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
765951|NCT01533753|P2|Participant Flow|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
765952|NCT01533753|P1|Participant Flow|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
765953|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
765954|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
765955|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
765956|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
765957|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
765958|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
766018|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766019|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
765959|NCT01533753|O2|Outcome|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
765960|NCT01533753|O1|Outcome|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
765961|NCT01533753|E2|Reported Event|Arm B: Venlafaxine|"Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.~Venlafaxine: Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days."
765962|NCT01533753|E1|Reported Event|Arm A: Gabapentin|"Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.~Gabapentin: Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days."
765963|NCT01533597|B3|Baseline|Total|Total of all reporting groups
766420|NCT01532128|B4|Baseline|Total|Total of all reporting groups
765966|NCT01533597|P2|Participant Flow|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765967|NCT01533597|P1|Participant Flow|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765968|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765969|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765970|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765971|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765972|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765973|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765974|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765975|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765976|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765977|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765978|NCT01533597|O2|Outcome|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765979|NCT01533597|O1|Outcome|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765980|NCT01533597|E2|Reported Event|Solifenacin Plus Tamsulosin|Solifenacin plus Tamsulosin: Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
765981|NCT01533597|E1|Reported Event|Solifenacin|Solifenacin: Solifenacin (5mg, qd, oral)
765982|NCT01533493|B3|Baseline|Total|Total of all reporting groups
765983|NCT01533493|B2|Baseline|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
765984|NCT01533493|B1|Baseline|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
765985|NCT01533493|P2|Participant Flow|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
766020|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766021|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766022|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
765986|NCT01533493|P1|Participant Flow|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
765987|NCT01533493|O2|Outcome|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
765988|NCT01533493|O1|Outcome|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
766038|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
765989|NCT01533493|E2|Reported Event|Placebo|"Subjects randomized to receive memantine-matched placebo in addition to open-label OROS-Methylphenidate~Placebo : Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
765990|NCT01533493|E1|Reported Event|Memantine|"Subjects randomized to receive Memantine in addition to open-label OROS-Methylphenidate~Memantine Hydrochloride : Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.~OROS-Methylphenidate : OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment."
765991|NCT01533428|B3|Baseline|Total|Total of all reporting groups
765992|NCT01533428|B2|Baseline|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
765993|NCT01533428|B1|Baseline|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
765994|NCT01533428|P2|Participant Flow|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
765995|NCT01533428|P1|Participant Flow|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
765996|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
765997|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
765998|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
765999|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766000|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766001|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766002|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766003|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766004|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766005|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766006|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766007|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766008|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766009|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766010|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766011|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766012|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766013|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766014|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766015|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766016|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766017|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766576|NCT01530243|O2|Outcome|Terazosin|Terazosine: 2 mg BID
766024|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766025|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766026|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766027|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766028|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766029|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766030|NCT01533428|O2|Outcome|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766031|NCT01533428|O1|Outcome|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766032|NCT01533428|E2|Reported Event|Placebo|Placebo patch was applied for 30 minutes to the painful area(s) on Day 1
766033|NCT01533428|E1|Reported Event|Capsaicin 8%|Capsaicin 8% patch was applied for 30 minutes to the painful area(s) on Day 1
766034|NCT01533259|B1|Baseline|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
766035|NCT01533259|P1|Participant Flow|Stribild|Switch from existing treatment regimen to Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regiment (STR) once daily for 48 weeks
766036|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
766037|NCT01533259|O1|Outcome|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
766135|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766039|NCT01533259|E1|Reported Event|Stribild|Switch from existing treatment regimen to Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily for 48 weeks
766040|NCT01533246|B1|Baseline|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766041|NCT01533246|P1|Participant Flow|Treatment (Linsitinib)|"Patients receive linsitinib 150mg PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766042|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766043|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766044|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766045|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766046|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766047|NCT01533246|O1|Outcome|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766048|NCT01533246|E1|Reported Event|Treatment (Linsitinib)|"Patients receive linsitinib 150mg, PO BID on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo serum and plasma sample collection at baseline, on day 1 of courses 2 and 4, and after completion of study treatment for correlative studies.~linsitinib: Given PO~laboratory biomarker analysis: Correlative studies"
766049|NCT01533181|B3|Baseline|Total|Total of all reporting groups
766050|NCT01533181|B2|Baseline|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
766051|NCT01533181|B1|Baseline|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
766052|NCT01533181|P2|Participant Flow|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
766053|NCT01533181|P1|Participant Flow|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
766054|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
766562|NCT01530243|P4|Participant Flow|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
766055|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
766056|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
766057|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
766058|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
766059|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
766060|NCT01533181|O2|Outcome|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
766061|NCT01533181|O1|Outcome|Arm A: Topotecan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
766062|NCT01533181|E2|Reported Event|Arm B: OS-906|OS-906 (linsitinib) daily, continuously, every 3 weeks.
766063|NCT01533181|E1|Reported Event|Arm A: Topotocan|Participants receive topotecan hydrochloride IV over 30 minutes or orally (PO) daily (QD) on days 1-5. Patients may crossover to Arm B at the time of progressive disease.
766064|NCT01533116|B5|Baseline|Total|Total of all reporting groups
766065|NCT01533116|B4|Baseline|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766066|NCT01533116|B3|Baseline|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
767619|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
766067|NCT01533116|B2|Baseline|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766068|NCT01533116|B1|Baseline|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766069|NCT01533116|P4|Participant Flow|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766070|NCT01533116|P3|Participant Flow|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766071|NCT01533116|P2|Participant Flow|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766072|NCT01533116|P1|Participant Flow|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766073|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766074|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766075|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766076|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766077|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766078|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766079|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766080|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766081|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766082|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766083|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766084|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766085|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766086|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766258|NCT01532934|O1|Outcome|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
766087|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766088|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766089|NCT01533116|O4|Outcome|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766090|NCT01533116|O3|Outcome|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766091|NCT01533116|O2|Outcome|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766092|NCT01533116|O1|Outcome|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766093|NCT01533116|E4|Reported Event|30 mg BIA 9-1067|"30 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766094|NCT01533116|E3|Reported Event|15 mg BIA 9-1067|"15 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766095|NCT01533116|E2|Reported Event|5 mg BIA 9-1067|"5 mg BIA 9-1067 once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28~BIA 9-1067~levodopa/carbidopa~levodopa/benserazide"
766096|NCT01533116|E1|Reported Event|Placebo|"Placebo once-daily for 28 days single-dose of levodopa/carbidopa 100/25 mg on Day 21 single-dose of levodopa/benserazide 100/25 mg on Day 28.~Placebo~levodopa/carbidopa~levodopa/benserazide"
766097|NCT01533077|B5|Baseline|Total|Total of all reporting groups
766098|NCT01533077|B4|Baseline|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766099|NCT01533077|B3|Baseline|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766100|NCT01533077|B2|Baseline|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766101|NCT01533077|B1|Baseline|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766102|NCT01533077|P4|Participant Flow|Group 4|"Period 1: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 2: BIA 9-1067 50 mg + Sinemet® 100/25 Period 3: Sinemet® 100/25 Period 4: BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766103|NCT01533077|P3|Participant Flow|Group 3|"Period 1: BIA 9-1067 50 mg + Sinemet® 100/25 Period 2: Sinemet® 100/25 Period 3: BIA 9-1067 50 mg Period 4: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766104|NCT01533077|P2|Participant Flow|Group 2|"Period 1: Sinemet® 100/25 Period 2: BIA 9-1067 50 mg Period 3: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 4: BIA 9-1067 50 mg + Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766105|NCT01533077|P1|Participant Flow|Group 1|"Period 1: BIA 9-1067 50 mg Period 2: Sinemet® 100/25 1 h after the BIA 9-1067 50 mg Period 3: BIA 9-1067 50 mg + Sinemet® 100/25 Period 4: Sinemet® 100/25~BIA 9-1067: 50 mg of BIA 9-1067 (single-dose)~Sinemet® 100/25 mg: immediate-release levodopa/carbidopa 100/25 (single-dose)."
766106|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766107|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766108|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
766109|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766110|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766111|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
766112|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766113|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766114|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
766115|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766116|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766117|NCT01533077|O1|Outcome|BIA 9-1067 50 mg|BIA 9-1067 50 mg
766118|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766119|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766121|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766122|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766123|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766124|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766125|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766126|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766127|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766128|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766129|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766130|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766131|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766132|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766133|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766134|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766136|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766137|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766138|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766139|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766140|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766141|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766142|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766143|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766144|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766145|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766146|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766147|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766148|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766149|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766150|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766151|NCT01533077|O3|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766152|NCT01533077|O2|Outcome|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h BIA 9-1067 Levodopa 100 mg Carbidopa 25 mg
766153|NCT01533077|O1|Outcome|Sinemet® 100/25 mg|Levodopa 100 mg Carbidopa 25 mg
766154|NCT01533077|E4|Reported Event|Sinemet® 100/25 mg|Sinemet® 100/25 mg.
766155|NCT01533077|E3|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Concomitantly|BIA 9-1067 50 mg + Sinemet® 100/25 mg concomitantly.
766156|NCT01533077|E2|Reported Event|BIA 9-1067 50 mg + Sinemet® 100/25 mg Separated 1 h|BIA 9-1067 50 mg + Sinemet® 100/25 mg separated 1 h.
766157|NCT01533077|E1|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 50 mg.
766158|NCT01533038|B3|Baseline|Total|Total of all reporting groups
766159|NCT01533038|B2|Baseline|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
766160|NCT01533038|B1|Baseline|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
766205|NCT01532973|P7|Participant Flow|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766206|NCT01532973|P6|Participant Flow|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766161|NCT01533038|P2|Participant Flow|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
766162|NCT01533038|P1|Participant Flow|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
766163|NCT01533038|O2|Outcome|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
766219|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
766220|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
766221|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
766222|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
766164|NCT01533038|O1|Outcome|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
766165|NCT01533038|E2|Reported Event|Transurethral Resection of the Prostate|"Transurethral Resection of the Prostate surgery~Transurethral Resection of the Prostate: Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck."
766166|NCT01533038|E1|Reported Event|UroLift System|"UroLift System procedure~UroLift System: The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
766167|NCT01532999|B3|Baseline|Total|Total of all reporting groups
766168|NCT01532999|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766169|NCT01532999|B1|Baseline|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766170|NCT01532999|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766171|NCT01532999|P1|Participant Flow|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766172|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766207|NCT01532973|P5|Participant Flow|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766259|NCT01532934|O2|Outcome|Standard Care|Assessment only plus the usual range of pretrial services
766173|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766174|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766223|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
766224|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
766225|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
766175|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766176|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766177|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766178|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766179|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766180|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766181|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766182|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766183|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766208|NCT01532973|P4|Participant Flow|GT1 HCV 200-mg Elbasvir (Panel D)|Participants with GT1 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766209|NCT01532973|P3|Participant Flow|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766260|NCT01532934|O1|Outcome|BMI+SC|"brief MI + standard care~standard care"
766184|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766185|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766186|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766187|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766188|NCT01532999|O2|Outcome|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766189|NCT01532999|O1|Outcome|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766190|NCT01532999|E2|Reported Event|Present Centered Group Therapy|"Present Centered Group Therapy (PCGT) serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).~Present Centered Group Therapy: The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness)."
766191|NCT01532999|E1|Reported Event|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.~Mindfulness Based Stress Reduction: MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes."
766192|NCT01532973|B10|Baseline|Total|Total of all reporting groups
766193|NCT01532973|B9|Baseline|Placebo|Participants with GT1, GT3 or GT1a HCV who received placebo in Parts I, II, or II of the study.
766194|NCT01532973|B8|Baseline|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir for 5 consecutive days during Part III of the study.
766195|NCT01532973|B7|Baseline|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir for 5 consecutive days during Part III of the study.
766196|NCT01532973|B6|Baseline|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir for 5 consecutive days during Part II of the study.
766197|NCT01532973|B5|Baseline|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir for 5 consecutive days during Part II of the study.
766198|NCT01532973|B4|Baseline|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir for 5 consecutive days during Part II of the study.
766199|NCT01532973|B3|Baseline|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir for 5 consecutive days during Part I of the study.
766200|NCT01532973|B2|Baseline|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir for 5 consecutive days during Part I of the study.
766201|NCT01532973|B1|Baseline|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis who received 10 -mg elbasvir for 5 consecutive days during Part I of the study.
766202|NCT01532973|P10|Participant Flow|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
766203|NCT01532973|P9|Participant Flow|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
766204|NCT01532973|P8|Participant Flow|GT3 HCV 200-mg Elbasvir (Panel H)|Participants with GT3 HCV receive 200-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766210|NCT01532973|P2|Participant Flow|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766211|NCT01532973|P1|Participant Flow|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with genotype (GT) 1 hepatitis C virus (HCV) receive 10 -mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766212|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
766213|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
766214|NCT01532973|O3|Outcome|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
766215|NCT01532973|O2|Outcome|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
766216|NCT01532973|O1|Outcome|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
766217|NCT01532973|O5|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
766218|NCT01532973|O4|Outcome|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
766226|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766227|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766228|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766229|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
766230|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766231|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766232|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
766233|NCT01532973|O3|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
766234|NCT01532973|O2|Outcome|GT1a HCV 50-mg Elbasvir (Panel J)|Participants with GT1a only HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
766235|NCT01532973|O1|Outcome|GT1a HCV 10-mg Elbasvir (Panel I)|Participants with GT1a only HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part III of the study.
766236|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
766237|NCT01532973|O3|Outcome|GT3 HCV 100-mg Elbasvir (Panel G)|Participants with GT3 HCV receive 100-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766238|NCT01532973|O2|Outcome|GT3 HCV 50-mg Elbasvir (Panel F)|Participants with GT3 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766239|NCT01532973|O1|Outcome|GT3 HCV 10-mg Elbasvir (Panel E)|Participants with GT3 HCV receive 10-mg elbasvir or matching placebo for 5 consecutive days during Part II of the study.
766240|NCT01532973|O4|Outcome|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during Parts I, II, or III of the study.
766241|NCT01532973|O3|Outcome|GT1 HCV 5-mg Elbasvir (Panel C)|Participants with GT1 HCV receive 5-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766242|NCT01532973|O2|Outcome|GT1 HCV 50-g Elbasvir (Panel B)|Participants with GT1 HCV receive 50-mg elbasvir or matching placebo for 5 consecutive days during Part I of the study.
766243|NCT01532973|O1|Outcome|GT1 HCV 10-mg Elbasvir (Panel A)|Participants with GT1 Hepatitis receive 10 -mg elbasvir for 5 consecutive days during Part I of the study.
766244|NCT01532973|E6|Reported Event|Post-Study|All participants who received 5, 10, 50, or 100 mg of elbasvir or placebo in treatment period of study
766245|NCT01532973|E5|Reported Event|Placebo|Participants with HCV GT1, GT3 or GT1a who received placebo during.
766246|NCT01532973|E4|Reported Event|100-mg Elbasvir|Participants with HCV GT3 who received 100-mg elbasvir
766247|NCT01532973|E3|Reported Event|50-mg Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 50-mg elbasvir
766248|NCT01532973|E2|Reported Event|10-g Elbasvir|Participants with HCV GT1, GT3, or GT1a who received 10-mg elbasvir
766249|NCT01532973|E1|Reported Event|5-mg Elbasvir|Participants with HCV GT1 who received 5 -mg elbasvir
766250|NCT01532934|B3|Baseline|Total|Total of all reporting groups
766251|NCT01532934|B2|Baseline|Standard Care (SC)|Standard Care: Individuals received assessment only, plus the usual range of services provided by Monroe County Pretrial
766252|NCT01532934|B1|Baseline|Brief Motivational Intervention Plus Standard Care (BMI+SC)|Brief Motivational Intervention plus Standard Care; Individuals received up to 4 intervention sessions plus assessment and the usual range of services provided by Monroe County Pretrial
766253|NCT01532934|P2|Participant Flow|Standard Care|"standard care~standard care: standard care"
766254|NCT01532934|P1|Participant Flow|Brief Therapy|"motivational enhancement therapy for substance use~motivational enhancement therapy: Four 45-minute MET sessions"
766563|NCT01530243|P3|Participant Flow|Tolterodine|Tolterodine: 2 mg daily
766262|NCT01532934|E1|Reported Event|Brief Motivational Intervention Plus Standard Care|There were no adverse events for members of this group.
766263|NCT01532869|B3|Baseline|Total|Total of all reporting groups
766264|NCT01532869|B2|Baseline|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766265|NCT01532869|B1|Baseline|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766266|NCT01532869|P2|Participant Flow|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766267|NCT01532869|P1|Participant Flow|Placebo|Participants received tocilizumab (TCZ) matched placebo by subcutaneous (SC) injection every week (qw) for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 milligrams [mg]) SC injection qw in the open-label period for Week 48 to Week 96.
766268|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766269|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766270|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766271|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766272|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766273|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766274|NCT01532869|O1|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766275|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766276|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766277|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766278|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766279|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766280|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766281|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766282|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766283|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766284|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766285|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766286|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766287|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766288|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766289|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766290|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766291|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766292|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766293|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766564|NCT01530243|P2|Participant Flow|Terazosin|Terazosin: 2 mg BID
766294|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766295|NCT01532869|O2|Outcome|Tocilizumab|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96.
766296|NCT01532869|O1|Outcome|Placebo|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96.
766297|NCT01532869|E6|Reported Event|Tocilizumab to Tocilizumab (up to 96 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for double-blind tocilizumab to open-label tocilizumab up to Week 96 are presented in this reporting group.
766298|NCT01532869|E5|Reported Event|Placebo to Tocilizumab (up to 96 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for double-blind placebo to open-label tocilizumab up to Week 96 are presented in this reporting group.
766299|NCT01532869|E4|Reported Event|Tocilizumab (up to 48 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 48 are presented in this reporting group.
766300|NCT01532869|E3|Reported Event|Placebo (up to 48 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 48 are presented in this reporting group.
766301|NCT01532869|E2|Reported Event|Tocilizumab (up to 24 Weeks)|Participants received TCZ (162 mg) by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then in the open-label period for Week 48 to Week 96. The data analyzed for TCZ up to Week 24 was presented in this reporting group.
766302|NCT01532869|E1|Reported Event|Placebo (up to 24 Weeks)|Participants received TCZ matched placebo by SC injection qw for Week 0 to Week 48 (blinded-treatment period) and then received TCZ (162 mg) SC injection qw in the open-label period for Week 48 to Week 96. The data analyzed for placebo up to Week 24 are presented in this reporting group.
766303|NCT01531725|B1|Baseline|BMS Implantation|Patients with a BMS implanted.
766304|NCT01531725|P1|Participant Flow|BMS Implantation|BMS implantation
766305|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
766306|NCT01531725|O1|Outcome|BMS Implantation|BMS implantation
766307|NCT01531725|E1|Reported Event|BMS Implantation|BMS implantation
766308|NCT01532635|B1|Baseline|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766309|NCT01532635|P1|Participant Flow|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766310|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766311|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766312|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766313|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766314|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766315|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766316|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766521|NCT01530464|E2|Reported Event|Ambrisentan Only|Ambrisentan 5 mg orally, followed by 48 h washout period. lowed by 48 h washout period.
766317|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766318|NCT01532635|O1|Outcome|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766319|NCT01532635|E1|Reported Event|Allogeneic HSCT Using Two Related Donors|"CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2.~TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28."
766320|NCT01532570|B5|Baseline|Total|Total of all reporting groups
766321|NCT01532570|B4|Baseline|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766322|NCT01532570|B3|Baseline|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766323|NCT01532570|B2|Baseline|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766324|NCT01532570|B1|Baseline|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766325|NCT01532570|P4|Participant Flow|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766326|NCT01532570|P3|Participant Flow|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766327|NCT01532570|P2|Participant Flow|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766328|NCT01532570|P1|Participant Flow|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766329|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766330|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
766331|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
766332|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
766333|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766334|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|
766335|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient No.2)|
766336|NCT01532570|O1|Outcome|Acute Neuro BD (Patient No.1)|
766337|NCT01532570|O2|Outcome|Acute Neuro-BD (Patient 2)|
766338|NCT01532570|O1|Outcome|Acute Neuro BD (Patient 1)|
766339|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766340|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766341|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766342|NCT01532570|O1|Outcome|Vascular-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766343|NCT01532570|O1|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766344|NCT01532570|O1|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766345|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766346|NCT01532570|O3|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766347|NCT01532570|O2|Outcome|Neuro-BD (Acute+Chronic Progressive)|"Acute; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.~Chronic Progressive; A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30."
766348|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766349|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766350|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766351|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766352|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766353|NCT01532570|O4|Outcome|Vascular BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766354|NCT01532570|O3|Outcome|Chronic Progressive Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766355|NCT01532570|O2|Outcome|Acute Neuro-BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766356|NCT01532570|O1|Outcome|Intestinal BD|A-650, 5 mg/kg, iv infusion over a period of more than 2 hours. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766414|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
766357|NCT01532570|E1|Reported Event|TA-650|TA-650: TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
766358|NCT01532453|B3|Baseline|Total|Total of all reporting groups
766359|NCT01532453|B2|Baseline|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
766360|NCT01532453|B1|Baseline|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
766361|NCT01532453|P2|Participant Flow|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
766362|NCT01532453|P1|Participant Flow|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
766363|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
766364|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
766365|NCT01532453|O2|Outcome|MD-3511356|MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
766366|NCT01532453|O1|Outcome|Standard Sun Protection Measures|Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
766367|NCT01532453|E2|Reported Event|MD-3511356|"Patients receive detailed information on standardised sun protection measures. Additionally, they will be provided free of charge with MD-3511356 for application to sun exposed skin areas once daily in the morning for 24 months. MD 3511356 lotion will be applied topically on the sun-exposed skin areas (face, neck, head, forearms and hands) in doses corresponding to the surface extent (see chapter 6.1). The dispensers will be provided with a dosage pump to allow application of reproducible amounts (each pump 0,5 g).~MD-3511356: Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun."
766368|NCT01532453|E1|Reported Event|Standard Sun Protection Measures|"Detailed information on standardised sun protection measures and application of self-provided sunscreen products. The Investigator may decide on an individual reimbursement of patient's expenditure (out of the centre's budget).~Standard Sun Protection Measures: Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product."
766369|NCT01532414|B4|Baseline|Total|Total of all reporting groups
766370|NCT01532414|B3|Baseline|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
766371|NCT01532414|B2|Baseline|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
766372|NCT01532414|B1|Baseline|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
766373|NCT01532414|P3|Participant Flow|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
766374|NCT01532414|P2|Participant Flow|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
766375|NCT01532414|P1|Participant Flow|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months Subjects with morning testosterone <300ng/dL after 6 weeks of treatment were up-titrated to 25 mg/day"
766376|NCT01532414|O2|Outcome|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
766522|NCT01530464|E1|Reported Event|Aminophylline Only|Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.
766377|NCT01532414|O1|Outcome|Androxal Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
766378|NCT01532414|O1|Outcome|Androxal Treated Subjects Pooled|"Androxal (enclomiphene citrate), 12.5 mg or 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
766379|NCT01532414|E3|Reported Event|Placebo|"Placebo oral capsules taken one time daily~Placebo: Oral capsule taken one time daily for 3 months"
766380|NCT01532414|E2|Reported Event|Androxal 25 mg|"Androxal (enclomiphene citrate), 25 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
766381|NCT01532414|E1|Reported Event|Androxal 12.5 mg|"Androxal (enclomiphene citrate), 12.5 mg oral capsules taken once daily~enclomiphene citrate: oral, capsules, taken one time daily, for 3 months"
766382|NCT01532362|B3|Baseline|Total|Total of all reporting groups
766383|NCT01532362|B2|Baseline|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766384|NCT01532362|B1|Baseline|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766385|NCT01532362|P2|Participant Flow|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766386|NCT01532362|P1|Participant Flow|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766387|NCT01532362|O2|Outcome|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766415|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
766388|NCT01532362|O1|Outcome|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766389|NCT01532362|E2|Reported Event|No Drug Intervention|no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766390|NCT01532362|E1|Reported Event|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
766391|NCT01532349|B3|Baseline|Total|Total of all reporting groups
766392|NCT01532349|B2|Baseline|4000 IU Vitamin D|Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
766393|NCT01532349|B1|Baseline|400 IU Vitamin D|Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
766394|NCT01532349|P2|Participant Flow|4000 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
766395|NCT01532349|P1|Participant Flow|400 IU Vitamin D|Children will be randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.
766396|NCT01532349|O2|Outcome|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
766397|NCT01532349|O1|Outcome|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
766398|NCT01532349|E2|Reported Event|4000 IU Vitamin D|"Children were be randomly allocated to receive cholecalciferol supplementation 4000 IU/day (28,000 IU weekly) according to the KDOQI recommended supplementation for children with mild 25D deficiency. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
766399|NCT01532349|E1|Reported Event|400 IU Vitamin D|"Children were randomly allocated to receive cholecalciferol supplementation 400 IU/day (2,800 IU/weekly), which is the recommended dietary allowance. Study participants will be prescribed any clinically indicated additional cholecalciferol supplementation once the 3-month laboratory measures have been obtained, based on serum 25D levels at the end of the study period.~Serum hepcidin was the primary outcome variable and was quantified at all visits."
766400|NCT01532141|B4|Baseline|Total|Total of all reporting groups
766401|NCT01532141|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
766402|NCT01532141|B2|Baseline|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
766403|NCT01532141|B1|Baseline|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
766404|NCT01532141|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
766405|NCT01532141|P2|Participant Flow|Group 2|"Period 1: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 2: 50 mg BIA 9-1067 alone Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
766406|NCT01532141|P1|Participant Flow|Group 1|"Period 1: 50 mg BIA 9-1067 alone Period 2: 50 mg BIA 9-1067 1 h before a single dose of rasagiline 1 mg Period 3: 50 mg BIA 9-1067 alone concomitantly single dose of rasagiline 1 mg~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)~Rasagiline: 1 mg rasagiline (single-dose)"
766407|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
766408|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
766409|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
766410|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
766411|NCT01532141|O2|Outcome|BIA 9-1067 1h Before Rasagiline|BIA 9-1067 1h before Rasagiline.
766412|NCT01532141|O1|Outcome|BIA 9-1067 Alone|BIA 9-1067 alone.
766413|NCT01532141|O3|Outcome|BIA 9-1067 Concomitant Rasagiline|BIA 9-1067 concomitant rasagiline.
766421|NCT01532128|B3|Baseline|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
766422|NCT01532128|B2|Baseline|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
766423|NCT01532128|B1|Baseline|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
766424|NCT01532128|P3|Participant Flow|Group 3|"Period 1: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 2: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 3: rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
766425|NCT01532128|P2|Participant Flow|Group 2|"Period 1: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg Period 2: rasagiline 1 mg Period 3: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
766426|NCT01532128|P1|Participant Flow|Group 1|"Period 1: rasagiline 1 mg Period 2: 50 mg BIA 9-1067. 1 hour later rasagiline 1 mg Period 3: rasagiline 1 mg concomitantly with BIA 9-1067 50 mg~rasagiline: 1 mg rasagiline (single-dose)~BIA 9-1067: 50 mg BIA 9-1067 (single-dose)"
766427|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
766428|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
766429|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
766430|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
766431|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
766432|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
766433|NCT01532128|O3|Outcome|Rasagiline Concomitant BIA 9-1067|Rasagiline concomitant BIA 9-1067.
766434|NCT01532128|O2|Outcome|Rasagiline 1 h After BIA 9-1067|Rasagiline 1 h after BIA 9-1067.
766435|NCT01532128|O1|Outcome|Rasagiline Alone|Rasagiline alone.
766436|NCT01532128|E4|Reported Event|Rasagiline Concomitant BIA 9-1067|
766437|NCT01532128|E3|Reported Event|Rasagiline 1 h After BIA 9-1067|
766438|NCT01532128|E2|Reported Event|Rasagiline Alone|
766439|NCT01532128|E1|Reported Event|Before Treatment|
766440|NCT01531998|B1|Baseline|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
766441|NCT01531998|P1|Participant Flow|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
766523|NCT01530399|B7|Baseline|Total|Total of all reporting groups
766442|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
766443|NCT01531998|O1|Outcome|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
766444|NCT01531998|E1|Reported Event|Siltuximab + Bortezomib + Lenalidomide|Induction of Lenalidomide 25 mg orally Days 1-14; Bortezomib 1.3 mg/m^2 intravenous Days 1, 4, 8 and 11; Dexamethasone 20 mg orally Days 1, 2, 4, 5, 8, 9, 11, 12. Siltuximab 11 mg/kg intravenous Day 1. If delayed transplant, induction therapy continued up to 2 cycles beyond achieving a CR/nCR then transition to maintenance therapy (Lenalidomide at last tolerated dose Day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg). Siltuximab 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy. Bortezomib at last tolerated dose Day 1 and Day 8 Dexamethasone at last tolerated dose or 20 mg weekly.
766445|NCT01531387|B3|Baseline|Total|Total of all reporting groups
766446|NCT01531387|B2|Baseline|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766447|NCT01531387|B1|Baseline|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766448|NCT01531387|P2|Participant Flow|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766449|NCT01531387|P1|Participant Flow|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766450|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766451|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766452|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766453|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766454|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766455|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766456|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766457|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766458|NCT01531387|O2|Outcome|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766459|NCT01531387|O1|Outcome|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766460|NCT01531387|E2|Reported Event|Standard Therapy: Observation|Half of the subjects will be randomized to clinical observation only, which includes monthly visits with clinical evaluations, laboratory tests, and TCD endpoint examinations
766461|NCT01531387|E1|Reported Event|Hydroxyurea|"Half of the subjects will be randomized to hydroxyurea, taken as capsules (300 mg, 400 mg, or 500 mg), or as a liquid formulation (100 mg/mL). Hydroxyurea will be administered once daily by mouth. Subjects will be monitored monthly with clinical evaluations, laboratory tests, and TCD endpoint examinations.~Hydroxyurea: Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs."
766462|NCT01531335|B3|Baseline|Total|Total of all reporting groups
766463|NCT01531335|B2|Baseline|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
766464|NCT01531335|B1|Baseline|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
766465|NCT01531335|P2|Participant Flow|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
766466|NCT01531335|P1|Participant Flow|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
766467|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
766468|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
766469|NCT01531335|O2|Outcome|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
766470|NCT01531335|O1|Outcome|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
766471|NCT01531335|E2|Reported Event|Hypocaloric Hyperproteic Nutrition|"15 kcal per kg of body weight and 1.7 grams of protein per kg~Hypocaloric hyperproteic nutrition: 15 kcal per kg of body weight and 1.7 grams of protein per kg."
766472|NCT01531335|E1|Reported Event|Standard Care|"Patients will receive normal nutritional regime of around 25 kcal per kg.~Standard care: 25 kcal per kg of body weight"
766473|NCT01531205|B1|Baseline|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766474|NCT01531205|P1|Participant Flow|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766475|NCT01531205|O2|Outcome|Participant Two|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766476|NCT01531205|O1|Outcome|Participant One|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766477|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766478|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766479|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766480|NCT01531205|O1|Outcome|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766481|NCT01531205|E1|Reported Event|Experimental: Drug and Hormonal Therapy With Salvage Surgery|Androgen Ablation (hormonal therapy before surgery), Cabazitaxel (chemotherapy before surgery), Salvage Surgery (radical prostatectomy), Post-operative Hormonal Therapy, Post-operative Follow-up
766482|NCT01530477|B4|Baseline|Total|Total of all reporting groups
766483|NCT01530477|B3|Baseline|Skeletal and Body Composition|"Skeletal and Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
766484|NCT01530477|B2|Baseline|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
766485|NCT01530477|B1|Baseline|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
766486|NCT01530477|P3|Participant Flow|Skeletal & Body Composition|"Skeletal & Body Composition was not a cohort that was actively recruited to, it is a cohort for reporting purposes. Subjects were able to consent and enroll to both Skeletal and Body Composition cohorts and these subjects will be counted for under this joint cohort."
766487|NCT01530477|P2|Participant Flow|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
766488|NCT01530477|P1|Participant Flow|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
766489|NCT01530477|O2|Outcome|Body Composition Only|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Body Composition Cohort.
766490|NCT01530477|O1|Outcome|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects). Subjects willing to participate in Skeletal & Body Composition are counted towards the 90 evaluable subject requirement of the protocol for the Skeletal Cohort.
766592|NCT01529645|B6|Baseline|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766491|NCT01530477|E2|Reported Event|Body Composition|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
766492|NCT01530477|E1|Reported Event|Skeletal|Recruitment for each cohort will include approximately equal male/female split (no gender bias). Depending on the weight category, for each cohort, a minimum of 30 adult subjects will be measured on two of the three systems, and 60 will be measured on all three systems (total of evaluable 90 subjects).
766493|NCT01530464|B3|Baseline|Total|Total of all reporting groups
766494|NCT01530464|B2|Baseline|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
766495|NCT01530464|B1|Baseline|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
766496|NCT01530464|P2|Participant Flow|Sequence B|Period 1: First intervention (Ambrisentan 5mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Aminophylline 500mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
766497|NCT01530464|P1|Participant Flow|Sequence A|Period 1: First intervention (Aminophylline 500mg, 24h) Period 2: Washout (24 hours) Period 3: Second intervention (Ambrisentan 5mg, 24h) Period 4: Washout (24h) Period 5: Third intervention (Aminophylline 500mg plus ambrisentan 5mg, 24h) Period 6: Washout (24h)
766498|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
766499|NCT01530464|O3|Outcome|Ambrisentan Alone|
766500|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
766501|NCT01530464|O1|Outcome|Aminophylline Alone|
766502|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
766503|NCT01530464|O3|Outcome|Ambrisentan Alone|
766504|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
766505|NCT01530464|O1|Outcome|Aminophylline Alone|
766506|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
766507|NCT01530464|O3|Outcome|Ambrisentan Alone|
766508|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
766509|NCT01530464|O1|Outcome|Aminophylline Alone|
766510|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
766511|NCT01530464|O3|Outcome|Ambrisentan Alone|
766512|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
766513|NCT01530464|O1|Outcome|Aminophylline Alone|
766514|NCT01530464|O4|Outcome|Ambrisentan in Presence of Aminophylline|
766515|NCT01530464|O3|Outcome|Ambrisentan Alone|
766516|NCT01530464|O2|Outcome|Aminophylline in Presence of Ambrisentan|
766517|NCT01530464|O1|Outcome|Aminophylline Alone|
766518|NCT01530464|O2|Outcome|Sequence B|"Period 1: Ambrisentan 5 mg orally, followed by 48 h washout period. Period 2: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
766519|NCT01530464|O1|Outcome|Sequence A|"Period 1: Aminophylline 500 mg orally (corresponding to 395 mg theophylline), followed by 48 h washout period.~Period 2: Ambrisentan 5 mg orally, followed by 48 h washout period.. Period 3: Aminophylline, 500 mg plus Ambrisentan, 5 mg orally, followed by 48 h washout period."
766520|NCT01530464|E3|Reported Event|Combined Aminophylline and Ambrisentan|Combined single doses of Aminophylline 400 mg and ambrisentan 5 mg, followed by a 48 h washout period
766550|NCT01530334|O1|Outcome|Gefitinib|250 mg/die, oral
766524|NCT01530399|B6|Baseline|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
766525|NCT01530399|B5|Baseline|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
766526|NCT01530399|B4|Baseline|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
766527|NCT01530399|B3|Baseline|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
766528|NCT01530399|B2|Baseline|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
766529|NCT01530399|B1|Baseline|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
766530|NCT01530399|P6|Participant Flow|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
766531|NCT01530399|P5|Participant Flow|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
766532|NCT01530399|P4|Participant Flow|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
766817|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766533|NCT01530399|P3|Participant Flow|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
766534|NCT01530399|P2|Participant Flow|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
766535|NCT01530399|P1|Participant Flow|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
766536|NCT01530399|O6|Outcome|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
766537|NCT01530399|O5|Outcome|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
766538|NCT01530399|O4|Outcome|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
766539|NCT01530399|O3|Outcome|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
766540|NCT01530399|O2|Outcome|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
766541|NCT01530399|O1|Outcome|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
766542|NCT01530399|E6|Reported Event|Tranexamic Acid|saline: A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
766543|NCT01530399|E5|Reported Event|Saline|Tranexamic Acid: Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
766544|NCT01530399|E4|Reported Event|MDCO 4|MDCO-2010 Dose 4: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
766545|NCT01530399|E3|Reported Event|MDCO 3|MDCO-2010 Dose 3: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
766546|NCT01530399|E2|Reported Event|MDCO 2|MDCO-2010 Dose 2: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
766547|NCT01530399|E1|Reported Event|MDCO 1|MDCO-2010 Dose 1: MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
766548|NCT01530334|B1|Baseline|Gefitinib|250 mg/die, oral
766549|NCT01530334|P1|Participant Flow|Gefitinib|250 mg/die, oral
766577|NCT01530243|O1|Outcome|Placebo|Placebo: same as tolterodine and terazosin dose
766578|NCT01530243|E4|Reported Event|Tolterodine + Terazosin|Tolterodine + Terazosin: 2mg daily and 2mg BID
766579|NCT01530243|E3|Reported Event|Tolterodine|Tolterodine: 2 mg daily
766580|NCT01530243|E2|Reported Event|Terazosin|Terazosin: 2 mg BID
766581|NCT01530243|E1|Reported Event|Placebo|Placebo: same as tolterodine and terazosin dose
766582|NCT01530087|B1|Baseline|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
766583|NCT01530087|P1|Participant Flow|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
766584|NCT01530087|O1|Outcome|Treatment|"CASTLE Barrier~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
766585|NCT01530087|O1|Outcome|Treatment|CASTLE Barrier: Prototype barrier used in place of previous two piece device
766586|NCT01530087|E1|Reported Event|Subjects With Ileostomy or Colostomy|"CASTLE Barrier ostomy device~CASTLE barrier: Prototype barrier to be used in place of current two piece device"
766587|NCT01529645|B11|Baseline|Total|Total of all reporting groups
766588|NCT01529645|B10|Baseline|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766589|NCT01529645|B9|Baseline|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766590|NCT01529645|B8|Baseline|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766591|NCT01529645|B7|Baseline|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766818|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766593|NCT01529645|B5|Baseline|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766594|NCT01529645|B4|Baseline|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766595|NCT01529645|B3|Baseline|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766596|NCT01529645|B2|Baseline|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766597|NCT01529645|B1|Baseline|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766598|NCT01529645|P10|Participant Flow|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766599|NCT01529645|P9|Participant Flow|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766600|NCT01529645|P8|Participant Flow|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766601|NCT01529645|P7|Participant Flow|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766602|NCT01529645|P6|Participant Flow|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766603|NCT01529645|P5|Participant Flow|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766604|NCT01529645|P4|Participant Flow|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on day 1 of this study.
766605|NCT01529645|P3|Participant Flow|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766606|NCT01529645|P2|Participant Flow|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766607|NCT01529645|P1|Participant Flow|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766608|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766609|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766610|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766611|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766709|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766612|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766613|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766614|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766615|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766616|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766617|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766618|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766619|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766620|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766621|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766622|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
766819|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766623|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766624|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766625|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766626|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
766627|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766628|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766629|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766630|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766631|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766632|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766633|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766634|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766635|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766636|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766637|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766638|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766639|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766640|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766641|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766642|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766710|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
766643|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766644|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766645|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766646|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766647|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766648|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766649|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766650|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766651|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766652|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766653|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766654|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766655|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766656|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766657|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766658|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766659|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766660|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766661|NCT01529645|O3|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766662|NCT01529645|O2|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766663|NCT01529645|O1|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766664|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
766665|NCT01529645|O3|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766666|NCT01529645|O2|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766667|NCT01529645|O1|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766668|NCT01529645|O4|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day1 of this study.
766669|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766670|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766671|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766672|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766673|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766711|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766674|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766675|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766676|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766677|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766678|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766679|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766680|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766681|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766682|NCT01529645|O10|Outcome|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766683|NCT01529645|O9|Outcome|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766684|NCT01529645|O8|Outcome|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766685|NCT01529645|O7|Outcome|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766686|NCT01529645|O6|Outcome|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766687|NCT01529645|O5|Outcome|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766688|NCT01529645|O4|Outcome|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766689|NCT01529645|O3|Outcome|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766690|NCT01529645|O2|Outcome|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766691|NCT01529645|O1|Outcome|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766692|NCT01529645|E10|Reported Event|Licensed TdaP|Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on day 1 of this study.
766693|NCT01529645|E9|Reported Event|Group T5D4aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766694|NCT01529645|E8|Reported Event|Group T5D4aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766695|NCT01529645|E7|Reported Event|Group T5D4aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766696|NCT01529645|E6|Reported Event|Group T5D2aP4|Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766697|NCT01529645|E5|Reported Event|Group T5D2aP2|Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766698|NCT01529645|E4|Reported Event|Group T5D2aP1|Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on day 1 of this study.
766699|NCT01529645|E3|Reported Event|Group aP4|Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this study.
766700|NCT01529645|E2|Reported Event|Group aP2|Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
766701|NCT01529645|E1|Reported Event|Group aP1|Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
766702|NCT01529632|B3|Baseline|Total|Total of all reporting groups
766703|NCT01529632|B2|Baseline|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766704|NCT01529632|B1|Baseline|QVA149|QVA149 plus placebo once daily for 28 days.
766705|NCT01529632|P2|Participant Flow|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766706|NCT01529632|P1|Participant Flow|QVA149|QVA149 plus placebo once daily for 28 days.
766707|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766708|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
766712|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
766713|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766714|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
766715|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766716|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
766717|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766718|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
766719|NCT01529632|O2|Outcome|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766720|NCT01529632|O1|Outcome|QVA149|QVA149 plus placebo once daily for 28 days.
766721|NCT01529632|E2|Reported Event|QAB149 + NVA237|Indacaterol (QAB149) plus glycopyrronium bromide (NVA237) once daily for 28 days.
766722|NCT01529632|E1|Reported Event|QVA149|QVA149 plus placebo once daily for 28 days.
766723|NCT01529515|B3|Baseline|Total|Total of all reporting groups
766724|NCT01529515|B2|Baseline|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
766725|NCT01529515|B1|Baseline|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
766726|NCT01529515|P4|Participant Flow|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
766820|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766727|NCT01529515|P3|Participant Flow|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
766728|NCT01529515|P2|Participant Flow|Open-Label Maintenance Phase: Paliperidone Palmitate 3-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
766729|NCT01529515|P1|Participant Flow|Open-Label Transition Phase: Paliperidone Palmitate 1-Month|Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64.
766730|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
766731|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
766732|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
766733|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
766734|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
766735|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
766736|NCT01529515|O2|Outcome|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
766737|NCT01529515|O1|Outcome|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
766738|NCT01529515|E3|Reported Event|Double-Blind Phase: Paliperidone Palmitate 3-Month (PP3M)|Paliperidone palmitate was administered at a dose of 175, 263, 350, or 525 milligram equivalents (mg eq) intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria. Participants received the same dose of study agent that was administered on Day 120 of the Maintenance Phase.
766739|NCT01529515|E2|Reported Event|Double-Blind Phase: Placebo|Matching placebo [20 percent (%) Intralipid solution] was administered intramuscular (IM) injection every 12 weeks up to participants had a relapse event or met discontinuation criteria.
766740|NCT01529515|E1|Reported Event|Open-Label Phase: PP1M + PP3M|PP1M= Paliperidone Palmitate 1 Month and PP3M= Paliperidone Palmitate 3 Month. Open-Label Transition Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 150 milligram equivalents (mg eq) on Day 1, 100 mg eq on Day 8, flexible dose (50, 75, 100, or 150 mg eq) on Day 36 and 64, and on Day 92 same dose as on Day 64. Open-Label Maintenance Phase: Paliperidone palmitate intramuscular (IM) injection was administered at a dose of 3.5-fold multiple of the PP1M dose received on Day 92 during the Transition Phase.
766741|NCT01529502|B7|Baseline|Total|Total of all reporting groups
766742|NCT01529502|B6|Baseline|Old Blood + Inhaled Nitric Oxide- Old Blood- Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766743|NCT01529502|B5|Baseline|Old Blood + Inhaled Nitric Oxide- Fresh Blood- Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766744|NCT01529502|B4|Baseline|Old Blood- Old Blood + Inhaled Nitric Oxide- Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766787|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766745|NCT01529502|B3|Baseline|Old Blood- Fresh Blood- Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766746|NCT01529502|B2|Baseline|Fresh Blood-Old Blood + Inhaled Nitric Oxide-Old Blood-|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766747|NCT01529502|B1|Baseline|Fresh Blood-Old Blood-Old Blood + Inhaled Nitric Oxide|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD + inhaled NITRIC OXIDE Red blood Cells auto-transfusion: Withdrawal from the same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766748|NCT01529502|P6|Participant Flow|Old Blood+iNO - Fresh Blood - Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
766749|NCT01529502|P5|Participant Flow|Old Blood - Old Blood+iNO - Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
766750|NCT01529502|P4|Participant Flow|Fresh Blood - Old Blood+iNO - Old Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
766751|NCT01529502|P3|Participant Flow|Old Blood+iNO - Old Blood - Fresh Blood|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
766779|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
767008|NCT01528605|E1|Reported Event|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
777586|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
766752|NCT01529502|P2|Participant Flow|Old Blood - Fresh Blood - Old Blood+iNO|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
766753|NCT01529502|P1|Participant Flow|Fresh Blood - Old Blood - Old Blood+iNO|"FRESH BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time.~OLD BLOOD:~Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~OLD BLOOD+iNO Red blood Cells auto-transfusion: Withdrawal from same overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time while breathing Nitric Oxide (NO)."
766754|NCT01529502|O3|Outcome|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766755|NCT01529502|O2|Outcome|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
766756|NCT01529502|O1|Outcome|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
766816|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766757|NCT01529502|O3|Outcome|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766758|NCT01529502|O2|Outcome|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
766759|NCT01529502|O1|Outcome|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
766760|NCT01529502|E3|Reported Event|Old Blood + Inhaled Nitric Oxide|"Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.~Inhaled Nitric Oxide (iNO) administration: Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion."
766761|NCT01529502|E2|Reported Event|Old Blood|Red blood Cells auto-transfusion: Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
766762|NCT01529502|E1|Reported Event|Fresh Blood|Red blood Cells auto-transfusion: Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
766763|NCT01529450|B3|Baseline|Total|Total of all reporting groups
766764|NCT01529450|B2|Baseline|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766765|NCT01529450|B1|Baseline|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766766|NCT01529450|P2|Participant Flow|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766767|NCT01529450|P1|Participant Flow|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766768|NCT01529450|O1|Outcome|All Participants|Participants received LDE225: 800-mg (4 200-mg capsules/day) capsule
766769|NCT01529450|O2|Outcome|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766770|NCT01529450|O1|Outcome|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766771|NCT01529450|E2|Reported Event|Resistance Developed Group|"Patients previously treated with non-LDE225 Smo inhibitor who were initially responsive but became resistant with progressive disease.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766772|NCT01529450|E1|Reported Event|Refractory Group|"Patients previously treated with non-LDE225 Smo inhibitor who were refractory.~LDE225: 800-mg (4 200-mg capsules/day) capsule"
766773|NCT01529385|B3|Baseline|Total|Total of all reporting groups
766774|NCT01529385|B2|Baseline|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766775|NCT01529385|B1|Baseline|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766776|NCT01529385|P2|Participant Flow|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766777|NCT01529385|P1|Participant Flow|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766778|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
777587|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
766780|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766781|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766782|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766783|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766784|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766785|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766786|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766788|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766789|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766790|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766791|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766792|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766793|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766794|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766795|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766796|NCT01529385|O2|Outcome|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766797|NCT01529385|O1|Outcome|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766798|NCT01529385|E2|Reported Event|Standard Diabetic Sock|"A standard diabetic sock that is designed to limit foot ulcer formation, but does not provide compression to the leg.~Standard diabetic sock: A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks"
766799|NCT01529385|E1|Reported Event|Mild Compression Diabetic Sock|"Diabetic socks that provide 18-25mm Hg of pressure to the lower extremities.~mild compression diabetic sock: A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks"
766800|NCT01529203|B1|Baseline|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
766801|NCT01529203|P1|Participant Flow|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
766802|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
766803|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
766994|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
766804|NCT01529203|O1|Outcome|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
766805|NCT01529203|E1|Reported Event|Azzalure and Restylane|"All subjects will be injected with Azzalure and Restylane~Botulinum Toxin Type A (Azzalure): Powder for solution for injection~Restylane ranges: Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)"
766806|NCT01529112|B3|Baseline|Total|Total of all reporting groups
766807|NCT01529112|B2|Baseline|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766808|NCT01529112|B1|Baseline|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766809|NCT01529112|P2|Participant Flow|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766810|NCT01529112|P1|Participant Flow|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766811|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766812|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766813|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766814|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766815|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766821|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766822|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766823|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766824|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766825|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766826|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766827|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766828|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766829|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766830|NCT01529112|O2|Outcome|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766831|NCT01529112|O1|Outcome|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766832|NCT01529112|E2|Reported Event|Lenvatinib Matched Placebo|Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
766833|NCT01529112|E1|Reported Event|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
766834|NCT01528969|B3|Baseline|Total|Total of all reporting groups
766835|NCT01528969|B2|Baseline|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
766836|NCT01528969|B1|Baseline|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
766837|NCT01528969|P2|Participant Flow|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks."
766838|NCT01528969|P1|Participant Flow|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks."
766839|NCT01528969|O2|Outcome|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%."
766840|NCT01528969|O1|Outcome|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w."
766841|NCT01528969|E2|Reported Event|Sorbitol|"A half of the subjects (n = 38) were randomly allocated into sorbitol group.~Subjects will chewed 2 pieces of sorbitol chewing gum (1,5, g/pellet) three times a day for five weeks. Each chewing gum pellet contained sorbitol 63% and sorbitol 2%.~None of the subjects had any adverse effects of the consumption of the chewing gum."
766842|NCT01528969|E1|Reported Event|Xylitol|"A half of the subjects (n = 37) were randomly allocated into xylitol group.~Subjects chewed 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day for five weeks. Each chewing gum pellet contained 65% xylitol w/w.~None of the subjects had any adverse effects of the consumption of the chewing gum."
766843|NCT01528891|B3|Baseline|Total|Total of all reporting groups
766844|NCT01528891|B2|Baseline|Placebo|"Normal saline equivalent volume~Placebo~Of the 200 patients in this treatment arm, 2 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
766845|NCT01528891|B1|Baseline|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery~Of the 200 patients in this treatment arm, 5 were totally excluded from analysis due to administration of medications that were not a part of the anesthetic protocol."
766846|NCT01528891|P2|Participant Flow|Placebo|"Normal saline equivalent volume~Placebo"
766847|NCT01528891|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
766848|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
766849|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
766850|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
766851|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
766852|NCT01528891|O2|Outcome|Placebo|"Normal saline equivalent volume~Placebo"
766853|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
766854|NCT01528891|O2|Outcome|Placebo|"Normal saline~Placebo"
766855|NCT01528891|O1|Outcome|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery"
766856|NCT01528891|E2|Reported Event|Placebo|"Normal saline equivalent volume~Placebo"
766857|NCT01528891|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine~Dexmedetomidine: 0.5 micrograms/Kilogram one time rapid bolus 5 minutes prior to the end of surgery"
766858|NCT01528735|B3|Baseline|Total|Total of all reporting groups
766859|NCT01528735|B2|Baseline|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766860|NCT01528735|B1|Baseline|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766861|NCT01528735|P2|Participant Flow|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766862|NCT01528735|P1|Participant Flow|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766863|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766864|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766865|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766866|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766867|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766868|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766995|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
767241|NCT01526538|B2|Baseline|Sugar Pill|"Inactive placebo~sugar pill: placebo"
766869|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766870|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766871|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766872|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766873|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766874|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766875|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
814925|NCT01344460|O1|Outcome|Gadobutrol-Enhanced MRA|
766876|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766877|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766878|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766879|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766880|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766881|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766882|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766883|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766884|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766996|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
766997|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
766885|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766886|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766887|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766888|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766889|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766890|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766891|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766892|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766893|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766894|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766895|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766896|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766897|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766898|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766899|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766900|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766998|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
766999|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
766901|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766902|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766903|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766904|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766905|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766906|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766907|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766908|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766909|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766910|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766911|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766912|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766913|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766914|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766915|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766916|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
767000|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
767001|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
766917|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766918|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766919|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766920|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766921|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766922|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766923|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766924|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766925|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766926|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766927|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766928|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766929|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766930|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766931|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766932|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
767002|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
767003|NCT01528605|E6|Reported Event|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
766933|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766934|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766935|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766936|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766937|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766938|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766939|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766940|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766941|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766942|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766943|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766944|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766945|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766946|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766947|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766948|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
767004|NCT01528605|E5|Reported Event|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
767005|NCT01528605|E4|Reported Event|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
766949|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766950|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766951|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766952|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766953|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766954|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766955|NCT01528735|O2|Outcome|600mg Deleobuvir and 120mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir and 120 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766956|NCT01528735|O1|Outcome|600mg Deleobuvir and 80mg Faldaprevir|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir and 80 mg once daily (qd) faldaprevir in combination with standard weight-based dose of ribavirin (RBV). Followed by 24 weeks of 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV).
766957|NCT01528735|E4|Reported Event|Faldap/pegIFN/RBV:120mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
766958|NCT01528735|E3|Reported Event|Faldap/pegIFN/RBV:80mg Faldap and 600mg Del.|Patients received 24 weeks 120 mg once daily (qd) faldaprevir (faldap) in combination with once weekly subcutaneous injection of 180 μg pegylated interferon alfa-2a (PegIFN) and standard weight-based dose of ribavirin (RBV), following treatment of 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV).
766959|NCT01528735|E2|Reported Event|Faldap/Del/RBV:120mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid.) deleobuvir (del) and 120 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
766960|NCT01528735|E1|Reported Event|Faldap/Del/RBV:80mg Faldap and 600mg Del.|Patients received 8 weeks of 600mg twice daily (bid) deleobuvir (del) and 80 mg once daily (qd) faldaprevir (faldap) in combination with standard weight-based dose of ribavirin (RBV)
766961|NCT01528696|B3|Baseline|Total|Total of all reporting groups
766962|NCT01528696|B2|Baseline|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
766963|NCT01528696|B1|Baseline|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
766964|NCT01528696|P2|Participant Flow|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
766965|NCT01528696|P1|Participant Flow|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
767006|NCT01528605|E3|Reported Event|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
767007|NCT01528605|E2|Reported Event|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
777588|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
766966|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
766967|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
766968|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
766969|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
766970|NCT01528696|O2|Outcome|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
766971|NCT01528696|O1|Outcome|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
767029|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
814926|NCT01344460|O1|Outcome|Computed Tomographic Angiography (CTA)|
766972|NCT01528696|E2|Reported Event|Silverlon|"Obese patients undergoing cesarean section in this arm will receive Silverlon, a silver impregnated dressing~Silverlon: Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
766973|NCT01528696|E1|Reported Event|Standard Dressing|"Obese patients undergoing cesarean section in this arm will receive a standard island-type dressing~Standard Dressing: Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse."
766974|NCT01528605|B7|Baseline|Total|Total of all reporting groups
766975|NCT01528605|B6|Baseline|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
766976|NCT01528605|B5|Baseline|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
766977|NCT01528605|B4|Baseline|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
766978|NCT01528605|B3|Baseline|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
766979|NCT01528605|B2|Baseline|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
766980|NCT01528605|B1|Baseline|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
766981|NCT01528605|P6|Participant Flow|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
766982|NCT01528605|P5|Participant Flow|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
766983|NCT01528605|P4|Participant Flow|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
766984|NCT01528605|P3|Participant Flow|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
766985|NCT01528605|P2|Participant Flow|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
766986|NCT01528605|P1|Participant Flow|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
766987|NCT01528605|O6|Outcome|High Lutein Zeaxanthin|"Zeaxanthin plus lutein group~zeaxanthin plus lutein: one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks"
766988|NCT01528605|O5|Outcome|High Zeaxanthin|"zeaxanthin group~high zeaxanthin: one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks"
766989|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
766990|NCT01528605|O3|Outcome|High Lutein|"high lutein group~high lutein: one gelatine capsule containing 20mg lutein per day, for 96 weeks"
766991|NCT01528605|O2|Outcome|Low Lutein|"low lutein group~low lutein: one gelatine capsule containing 10mg lutein per day, for 96 weeks"
766992|NCT01528605|O1|Outcome|Placebo|"starch in hard shell gelatine capsules~placebo: Placebo, one gelatine capsule containing starch per day, for 96 weeks"
766993|NCT01528605|O4|Outcome|Low Lutein Zeaxanthin|"lutein plus zeaxanthin group~lutein plus zeaxanthin: one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks"
777589|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
767009|NCT01528592|B1|Baseline|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
767010|NCT01528592|P1|Participant Flow|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
767011|NCT01528592|O1|Outcome|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
767012|NCT01528592|E1|Reported Event|On / Off Medication|Subjects undergo MRI scanning in the medication off state and 1 hour after receiving medications.
767013|NCT01528345|B3|Baseline|Total|Total of all reporting groups
767014|NCT01528345|B2|Baseline|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767015|NCT01528345|B1|Baseline|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767016|NCT01528345|P2|Participant Flow|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767017|NCT01528345|P1|Participant Flow|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767018|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767019|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767020|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767021|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767022|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767023|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767024|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767025|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767026|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767027|NCT01528345|O1|Outcome|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767028|NCT01528345|O2|Outcome|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767030|NCT01528345|E2|Reported Event|Fulvestrant + Dovitinib Placebo|Fulvestrant in combination with a placebo matching Dovitinib.
767031|NCT01528345|E1|Reported Event|Fulvestrant + Dovitinib Active|Fulvestrant in combination with the study drug Dovitinib.
767032|NCT01528332|B3|Baseline|Total|Total of all reporting groups
767033|NCT01528332|B2|Baseline|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
767034|NCT01528332|B1|Baseline|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
767035|NCT01528332|P2|Participant Flow|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
767036|NCT01528332|P1|Participant Flow|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
767037|NCT01528332|O2|Outcome|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
767038|NCT01528332|O1|Outcome|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
767039|NCT01528332|E2|Reported Event|Control PRP Device|Control PRP device: Light wavelength 531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm², light on for 5 seconds, device worn for 30 minutes
767040|NCT01528332|E1|Reported Event|Pain Relief Patch|Pain Relief Patch: Light wavelength 453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm², 30 minutes
767041|NCT01528319|B1|Baseline|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767042|NCT01528319|P1|Participant Flow|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767043|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767044|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767045|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767046|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767047|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767048|NCT01528319|O1|Outcome|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767049|NCT01528319|E1|Reported Event|MG-1|Arthroscopic Bankart repair is applied for glenohumeral instability using MG-1
767050|NCT01528293|B3|Baseline|Total|Total of all reporting groups
767051|NCT01528293|B2|Baseline|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767082|NCT01527942|P1|Participant Flow|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
767052|NCT01528293|B1|Baseline|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767053|NCT01528293|P2|Participant Flow|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767054|NCT01528293|P1|Participant Flow|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767096|NCT01527513|O1|Outcome|Esl PART II|Eslicarbazepine acetate (ESL) 10-30 mg/kg/day QD (maximum 1200 mg/day).
767097|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
767055|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767056|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767057|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767058|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767059|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767242|NCT01526538|B1|Baseline|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
767060|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767061|NCT01528293|O2|Outcome|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767062|NCT01528293|O1|Outcome|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767063|NCT01528293|E2|Reported Event|Compression Therapy Only|"Standard of Care compression therapy only~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767064|NCT01528293|E1|Reported Event|ActiVAC System+ Compression Therapy|"ActiVAC System + Compression therapy group consisting of the application of this device along with compression therapy.~ActiVAC System + Compression therapy: The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.~Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations."
767065|NCT01528215|B3|Baseline|Total|Total of all reporting groups
767066|NCT01528215|B2|Baseline|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
767067|NCT01528215|B1|Baseline|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
767068|NCT01528215|P2|Participant Flow|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
767069|NCT01528215|P1|Participant Flow|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
767070|NCT01528215|O2|Outcome|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
767071|NCT01528215|O1|Outcome|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
767072|NCT01528215|E2|Reported Event|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
767073|NCT01528215|E1|Reported Event|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
767074|NCT01528150|B1|Baseline|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
767075|NCT01528150|P1|Participant Flow|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
767076|NCT01528150|O1|Outcome|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
767077|NCT01528150|E1|Reported Event|Accent MRI System|Accent MRI system will be implanted = Accent MRI Pacemaker + Tendril MRI Leads
767078|NCT01527942|B3|Baseline|Total|Total of all reporting groups
767079|NCT01527942|B2|Baseline|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
767080|NCT01527942|B1|Baseline|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
767081|NCT01527942|P2|Participant Flow|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
767243|NCT01526538|P2|Participant Flow|Sugar Pill|"Inactive placebo~sugar pill: placebo"
767083|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
767084|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
767085|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
767086|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
767087|NCT01527942|O2|Outcome|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
767088|NCT01527942|O1|Outcome|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
767089|NCT01527942|E2|Reported Event|Arm 2 - Placebo|"Preoperative IV Placebo (0.9 NaCl 100 ml) will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Placebo: Placebo - IV administration 0.9% 100 ml NaCl"
767090|NCT01527942|E1|Reported Event|Arm 1 - Active Drug|"Preoperative administration of 1,000 mg IV Acetaminophen will be administered after induction of general anesthesia and prior to incision and every 6 hours thereafter for 24 hours.~Acetaminophen: Intravenous Acetaminophen 1,000 mg IV"
767091|NCT01527513|B3|Baseline|Total|Total of all reporting groups
767092|NCT01527513|B2|Baseline|Placebo|Placebo QD
767093|NCT01527513|B1|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
767094|NCT01527513|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 10-30 mg/kg/day QD (maximum 1200 mg/day).
767095|NCT01527513|P1|Participant Flow|Placebo|Placebo Once-Daily (QD)
767099|NCT01527513|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (BIA 2-093): ESL 30 mg/kg/day QD (maximum 1200 mg/day).
767100|NCT01527513|O1|Outcome|Placebo|Placebo QD
767101|NCT01527513|E3|Reported Event|Part II - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
767102|NCT01527513|E2|Reported Event|Part I - ESL|Eslicarbazepine acetate (ESL) - 30 mg/kg/day QD maximum 1200 mg/day.
767103|NCT01527513|E1|Reported Event|Placebo|Placebo QD
767104|NCT01527487|B3|Baseline|Total|Total of all reporting groups
767105|NCT01527487|B2|Baseline|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
767106|NCT01527487|B1|Baseline|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard;~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard"
767107|NCT01527487|P2|Participant Flow|Docetaxel+Cyclophosphamide: TC|"Docetaxel (T): 75 mg/m^2 by IV infusion (Day 1); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)tandard.~Administered every 21 days for 6 cycles followed by surgery."
767108|NCT01527487|P1|Participant Flow|Eribulin+Cyclophosphamide: ErC|"Eribulin (Er): 1.4 mg/m^2 by IV infusion (Days 1 and 8); Cyclophosphamide (C): 600 mg/m^2 by IV infusion (Day 1)~Administered every 21 days for 6 cycles followed by surgery."
767109|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
767110|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 IV (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle by IV infusion."
767111|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
767112|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion."
767113|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
767114|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion.~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle) by IV infusion."
767115|NCT01527487|O2|Outcome|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m^2 (Day 1 of each treatment cycle), by IV infusion~Cyclophosphamide (C): 600 mg/m^2 (Day 1 of each treatment cycle)"
767116|NCT01527487|O1|Outcome|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m^2 (Days 1 and 8 of each treatment cycle) by IV infusion~Cyclophosphamide (C): 600 mg/m^2 IV (Day 1 of each treatment cycle) by IV infusion"
767117|NCT01527487|E2|Reported Event|Docetaxel+Cyclophosphamide (TC)|"Docetaxel (T): 75 mg/m2 IV (Day 1), given by 1-hour IV infusion~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.~Docetaxel: Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks."
767118|NCT01527487|E1|Reported Event|Eribulin+Cyclophosphamide (ErC)|"Eribulin (Er): 1.4mg/m2 IV (Days 1 and 8) given short (≤1.5 minutes) IV infusion, per institutional standard~Cyclophosphamide (C): 600 mg/m2 IV (Day 1), given by IV infusion, per institutional standard~Eribulin: 1.4 mg/m2 IV (Days 1 & 8), given short (≤15 minute) IV infusion, per institutional standard~Cyclophosphamide: Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard."
767119|NCT01527370|B1|Baseline|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
767120|NCT01527370|P1|Participant Flow|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
767121|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
767122|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
767123|NCT01527370|O1|Outcome|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
767124|NCT01527370|E1|Reported Event|Zoster Vaccine Live|A single dose of Zoster vaccine was administered on day 1. Participants were followed up to day 42 for safety and immunogenicity.
767125|NCT01527162|B1|Baseline|All Participants|We used a randomized cross-over design with eleven children with bilateral 9 CP, mean age 4.3 years. Subjects were randomized to their current SAFO worn or SAFO not worn for 2 weeks and then crossed over.
767126|NCT01527162|P2|Participant Flow|SAFO NOT Worn First, Then Worn|Child does not wear their prescirbed SAFO for 14 days by random assignment, then worn
767127|NCT01527162|P1|Participant Flow|SAFO Worn First, Then Not Worn|Child wears their prescribed SAFO for 14 days by random assignment and then not worn
767128|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wears their prescribed SAFO for 14 days
767129|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
767130|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
767131|NCT01527162|O1|Outcome|SAFO Worn|Child wears their prescribed SAFO for 14 days
767132|NCT01527162|O2|Outcome|SAFO Not Worn|Child does not wear the prescribed SAFO for 14 days
767133|NCT01527162|O1|Outcome|SAFO Worn|"Child wears their prescribed SAFO for 14 days~SAFO worn: Child wears their prescribed SAFO for 14 days by random assignment~SAFO not worn: Child does not wear their prescirbed SAFO for 14 days by random assignment"
767134|NCT01527162|E2|Reported Event|SAFO Not Worn|SAFO not worn: Child does ont wear their prescribed SAFO for 14 days by random assignment
767135|NCT01527162|E1|Reported Event|SAFO Worn|SAFO worn: Child wears their prescirbed SAFO for 14 dyas by random assignment
767136|NCT01527006|B3|Baseline|Total|Total of all reporting groups
767137|NCT01527006|B2|Baseline|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767138|NCT01527006|B1|Baseline|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767139|NCT01527006|P2|Participant Flow|Cohort ( ≥ 7 to < 12 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767140|NCT01527006|P1|Participant Flow|Cohort ( ≥ 2 to < 7 Years of Age)|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767141|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767142|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767244|NCT01526538|P1|Participant Flow|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
767245|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo~sugar pill: placebo"
767143|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767144|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767145|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767146|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767204|NCT01526902|E2|Reported Event|Lotrafilcon B / Air Optix MF (CONTROL)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
767147|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767148|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767149|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767150|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767151|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767152|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767153|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767154|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767155|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767246|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
767247|NCT01526538|O2|Outcome|Control|Placebo (sugar pill)
767156|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767157|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767158|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767159|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767160|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767161|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767300|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767162|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767163|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767164|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767165|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767166|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767167|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767168|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767169|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767170|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767171|NCT01527006|O4|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767172|NCT01527006|O3|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767248|NCT01526538|O1|Outcome|D-cycloserine|Study medication under investigation
767249|NCT01526538|O2|Outcome|Sugar Pill|"Inactive placebo~sugar pill: placebo"
767173|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767174|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767175|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767176|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767177|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767178|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767179|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767180|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767181|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767182|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767183|NCT01527006|O2|Outcome|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767184|NCT01527006|O1|Outcome|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767185|NCT01527006|E4|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767186|NCT01527006|E3|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Extension Phase|During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
767187|NCT01527006|E2|Reported Event|Cohort ( ≥ 7 to < 12 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767188|NCT01527006|E1|Reported Event|Cohort ( ≥ 2 to < 7 Years of Age) - For Core Study|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period.
767189|NCT01526902|B1|Baseline|Overall Study Population|Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
767239|NCT01526551|E1|Reported Event|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
767190|NCT01526902|P2|Participant Flow|Lotrafilcon B (AIR OPTIX MF) / Omafilcon A (PC 1-D MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
767191|NCT01526902|P1|Participant Flow|Omafilcon A (PC 1-D MF) / Lotrafilcon B (AIR OPTIX MF)|Subjects were randomly assigned into either the omafilcon A (PC 1-D) Multifocal with +0.75D over-correction in the non-dominant eye or the Air Optix Aqua (lotrafilcon B)Multifocal lenses as their initial pair. Lens Pair 1 were evaluated for fit, vision and comfort (1 hour after lens application). Following this evaluation and during this same visit, the subject then crossed-over into the alternative pair of study lenses. This second pair of lenses was also evaluated for fit, vision and comfort (1 hour after lens application).
767192|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
767193|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
767194|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
767195|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
767196|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
767197|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
767198|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
767199|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
767200|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
767201|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
767202|NCT01526902|O2|Outcome|Air Optix MF|(Control Lens) lotrafilcon B Air Optix Aqua Multifocal
767203|NCT01526902|O1|Outcome|PC1DMF|(Test Lens) omafilcon A Proclear 1-D multifocal lens
814927|NCT01344460|O2|Outcome|Unenhanced MRA|
767205|NCT01526902|E1|Reported Event|Omafilcon A / PC1DMF L2A (TEST)|Low-Med and High Add power groups were randomly assigned to either omafilcon A/Proclear Multifocal soft contact lenses (PC1DMF L2A) or lotrafilcon B/Air OPtix Aqua Multifocal soft contact lenses (Air Optix MF) then crossed-over into the alternative pair of study lenses.
767206|NCT01526785|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767207|NCT01526785|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa (4000 litre [L] scale) intravenous (IV) infusion administered for 52 weeks as per physician's routine practice.
767208|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767209|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767210|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767211|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767212|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767213|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767214|NCT01526785|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per physician's routine practice.
767215|NCT01526785|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa (4000 L scale) IV infusion administered for 52 weeks as per participant's routine practice.
767216|NCT01526733|B1|Baseline|All Enrolled Participants|All participants enrolled in the study.
767217|NCT01526733|P2|Participant Flow|Insulin-sham, Then Insulin-rHuPH20|"In Phase I, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injection administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Phase I and Phase II were separated by a washout period of 5 to 21 days."
767218|NCT01526733|P1|Participant Flow|Insulin-rHuPH20, Then Insulin-sham|"In Phase I, participants received 0.15 units per kilogram (U/kg) insulin (either insulin aspart or insulin lispro) as a continuous subcutaneous insulin infusion (CSII) for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 milliliter (mL) (150 U) injection of recombinant human hyaluronidase PH20 (rHuPH20).~In Phase II, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with a sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Phase I and II were separated by a washout period of 5 to 21 days."
767219|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767220|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767221|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767222|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767223|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767224|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767225|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767226|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767301|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767620|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767227|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767228|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767229|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767230|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767231|NCT01526733|O2|Outcome|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767232|NCT01526733|O1|Outcome|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767233|NCT01526733|E2|Reported Event|Insulin (Aspart or Lispro)-Sham|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days, with sham injections administered prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16.~Each Phase was separated by a washout period of 5 to 21 days."
767234|NCT01526733|E1|Reported Event|Insulin (Aspart or Lispro)-rHuPH20|"In Phase I or Phase II of the study, participants received 0.15 U/kg insulin (either insulin aspart or insulin lispro) as a CSII for 16 days. Prior to outpatient euglycemic clamps on Days 1 and 4 and prior to outpatient meal test procedures on Days 7, 10, 13, and 16, participants received a 1 mL (150 U) injection of rHuPH20.~Each Phase was separated by a washout period of 5 to 21 days."
767235|NCT01526551|B1|Baseline|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
767236|NCT01526551|P1|Participant Flow|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
767237|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
767238|NCT01526551|O1|Outcome|Intervention School|"High school students attending Wayne County and Monticello Ind. schools will be given opportunity to receive HPV vaccination in school clinic~HPV Vaccine and Disease Education: Increased education of disease and vaccine~Reduction of barriers: eliminate barriers to being vaccinated"
767250|NCT01526538|O1|Outcome|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
767251|NCT01526538|E2|Reported Event|Sugar Pill|"Inactive placebo~sugar pill: placebo"
767252|NCT01526538|E1|Reported Event|50 mg D-cycloserine|"active drug condition~d-cycloserine: 50 mg d-cycloserine"
767253|NCT01526213|B7|Baseline|Total|Total of all reporting groups
767254|NCT01526213|B6|Baseline|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767255|NCT01526213|B5|Baseline|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767256|NCT01526213|B4|Baseline|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767302|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767303|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767257|NCT01526213|B3|Baseline|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767258|NCT01526213|B2|Baseline|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767259|NCT01526213|B1|Baseline|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767260|NCT01526213|P6|Participant Flow|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
767261|NCT01526213|P5|Participant Flow|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
767262|NCT01526213|P4|Participant Flow|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
767263|NCT01526213|P3|Participant Flow|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
767264|NCT01526213|P2|Participant Flow|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
767265|NCT01526213|P1|Participant Flow|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|By randomized 3-way crossover design, the subject will receive single doses of fexofenadine 120 mg (2 60mg tablets) and 240 mL of water, grapefruit juice (GFJ), and furanocoumarin-free GFJ (depending on Williams design sequence), with at least 10 day washout in between each treatment period.
767266|NCT01526213|O3|Outcome|Furanocoumarin-free Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
767267|NCT01526213|O2|Outcome|Grapefruit Juice|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
767268|NCT01526213|O1|Outcome|Water|For juice and water comparisons, fexofenadine + grapefruit juice or fexofenadine + furanocoumarin-free grapefruit juice will be the test agent (numerator) and fexofenadine + water will be the reference standard (denominator).
767339|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
767340|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
767341|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
767269|NCT01526213|E6|Reported Event|Sequence 6: Furanocoumarin-free GFJ, Water, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767270|NCT01526213|E5|Reported Event|Sequence 5: Furanocoumarin-free GFJ, GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767271|NCT01526213|E4|Reported Event|Sequence 4: GFJ, Water, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767304|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767305|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767272|NCT01526213|E3|Reported Event|Sequence 3: GFJ, Furanocoumarin-free GFJ, Water|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767273|NCT01526213|E2|Reported Event|Sequence 2: Water, Furanocoumarin-free GFJ, GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767274|NCT01526213|E1|Reported Event|Sequence 1: Water, GFJ, Furanocoumarin-free GFJ|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice (GFJ), and furanocoumarin-free grapefruit juice (depending on Williams design sequence) with at least 10 day washout in between each treatment period.
767275|NCT01526148|B3|Baseline|Total|Total of all reporting groups
767276|NCT01526148|B2|Baseline|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
767277|NCT01526148|B1|Baseline|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
767278|NCT01526148|P2|Participant Flow|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
767279|NCT01526148|P1|Participant Flow|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
767280|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
767281|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
767282|NCT01526148|O2|Outcome|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
767283|NCT01526148|O1|Outcome|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
767284|NCT01526148|E2|Reported Event|Quetiapine|Quetiapine: Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
767285|NCT01526148|E1|Reported Event|Lithium|Lithium: Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
767286|NCT01525927|B3|Baseline|Total|Total of all reporting groups
767287|NCT01525927|B2|Baseline|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
767288|NCT01525927|B1|Baseline|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders."
767289|NCT01525927|P1|Participant Flow|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
767290|NCT01525927|O1|Outcome|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy."
767291|NCT01525927|E2|Reported Event|Chemotherapy Responders|"Patients who respond to chemotherapy are treated with reduced dose radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~Reduced dose radiotherapy: Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.~Zero (0) participants analyzed"
777590|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
767292|NCT01525927|E1|Reported Event|Chemotherapy Non-responders|"Patients treated with three cycles neoadjuvant chemotherapy who do not exhibit response to chemotherapy are then allocated to recieve standard dose and schedule radiotherapy.~chemotherapy: Chemotherapy for three cycles prior to radiotherapy~radiotherapy: Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders.~Zero (0) participants analyzed"
767293|NCT01525849|B3|Baseline|Total|Total of all reporting groups
767294|NCT01525849|B2|Baseline|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767295|NCT01525849|B1|Baseline|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767296|NCT01525849|P2|Participant Flow|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767297|NCT01525849|P1|Participant Flow|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767298|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767299|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767306|NCT01525849|O2|Outcome|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767307|NCT01525849|O1|Outcome|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767308|NCT01525849|E2|Reported Event|Functional Endoscopic Sinus Surgery|Traditional endoscopic sinus surgery (maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy) using cutting, grasping, and microdebrider tools.
767309|NCT01525849|E1|Reported Event|Balloon Sinus Dilation|Balloon sinus dilation using XprESS Multi-Sinus Dilation Balloon or FinESS Sinus Treatment
767310|NCT01525745|B3|Baseline|Total|Total of all reporting groups
767311|NCT01525745|B2|Baseline|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
767312|NCT01525745|B1|Baseline|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
767313|NCT01525745|P2|Participant Flow|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
767314|NCT01525745|P1|Participant Flow|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
767315|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
767316|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
767317|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
767318|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
767319|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
767320|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
767321|NCT01525745|O2|Outcome|External Beam Radiation Therapy|"External Beam Radiation Therapy~External Beam Radiation Therapy: 10 consecutive days of standard radiation"
767322|NCT01525745|O1|Outcome|Radiosurgery/SBRT|"Radiosurgery/SBRT~Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments"
767323|NCT01525745|O2|Outcome|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
767324|NCT01525745|O1|Outcome|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
767325|NCT01525745|E2|Reported Event|B/External Beam Radiation Therapy|External Beam Radiation Therapy: 10 consecutive days of standard radiation
767326|NCT01525745|E1|Reported Event|A/Radiosurgery-SBRT|Radiosurgery/SBRT: 1, 3 or 5 SBRT treatments
767327|NCT01525667|B4|Baseline|Total|Total of all reporting groups
767328|NCT01525667|B3|Baseline|Placebo|Placebo: Single treatment, multiple injections
767329|NCT01525667|B2|Baseline|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
767330|NCT01525667|B1|Baseline|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
767331|NCT01525667|P3|Participant Flow|Placebo|Placebo: Single treatment, multiple injections
767332|NCT01525667|P2|Participant Flow|PLX-PAD High Dose|300M PLX-PAD : Single treatment, multiple injections
767333|NCT01525667|P1|Participant Flow|PLX-PAD Low Dose|150M PLX-PAD : Single treatment, multiple injections
767334|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
767335|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
767336|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
767337|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
767338|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
767342|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
767343|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
767344|NCT01525667|O2|Outcome|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
767345|NCT01525667|O1|Outcome|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
767346|NCT01525667|O3|Outcome|Placebo|Placebo: Single treatment, multiple injections
767347|NCT01525667|O2|Outcome|PLX-PAD High Dose|PLX-PAD high dose: Single treatment, multiple injections
767348|NCT01525667|O1|Outcome|PLX-PAD Low Dose|PLX-PAD low dose: Single treatment, multiple injections
767349|NCT01525667|E3|Reported Event|Placebo|Placebo: Single treatment, multiple injections
767350|NCT01525667|E2|Reported Event|300M PLX-PAD|PLX-PAD high dose: Single treatment, multiple injections
767351|NCT01525667|E1|Reported Event|150M PLX-PAD|PLX-PAD low dose: Single treatment, multiple injections
767352|NCT01525641|B1|Baseline|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767353|NCT01525641|P1|Participant Flow|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767354|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767355|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767356|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767357|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767358|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767359|NCT01525641|O1|Outcome|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767360|NCT01525641|E1|Reported Event|Subjects With Parkinson's Disease (PD)|Subjects with Parkinson's Disease (PD) were orally administered Mirapex LA: Pramipexole Hydrochloride Hydrate tablets with starting dose of 0.375 once daily after meal and increased by 0.75 mg/day at week 2. The daily may be increased by 0.75 mg/day at weekly intervals up to maintenance dose (standard dose: 1.5 to 4.5mg/day). Subjects with renal impairment were administered with the starting dose of 0.375 every other day for the first week, if necessary the dose may be increased by 0.375mg every week but not exceeding the daily dose of 2.25mg.
767361|NCT01525628|B6|Baseline|Total|Total of all reporting groups
767362|NCT01525628|B5|Baseline|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
767363|NCT01525628|B4|Baseline|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
767440|NCT01525615|P1|Participant Flow|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767364|NCT01525628|B3|Baseline|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
767365|NCT01525628|B2|Baseline|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767366|NCT01525628|B1|Baseline|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767367|NCT01525628|P5|Participant Flow|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
767368|NCT01525628|P4|Participant Flow|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
767369|NCT01525628|P3|Participant Flow|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
767370|NCT01525628|P2|Participant Flow|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767617|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767371|NCT01525628|P1|Participant Flow|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767372|NCT01525628|O5|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
767373|NCT01525628|O4|Outcome|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
767374|NCT01525628|O3|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
767375|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767376|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767377|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
767378|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
767379|NCT01525628|O1|Outcome|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
767380|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
767381|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
767382|NCT01525628|O1|Outcome|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
767441|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767593|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767383|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767384|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767385|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767386|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767387|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767388|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767389|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767390|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767391|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767392|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767393|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767394|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767395|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
777591|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
767396|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767397|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767398|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767399|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767400|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767401|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767402|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767403|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767404|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767405|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767406|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767407|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767408|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
777592|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
767409|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767410|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767411|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767412|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767413|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767414|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767415|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767416|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767417|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767418|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767419|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767420|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767421|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
777593|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
767422|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767423|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767424|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767425|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767426|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767427|NCT01525628|O2|Outcome|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767428|NCT01525628|O1|Outcome|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767429|NCT01525628|E5|Reported Event|Group E|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with raltegravir tablet 400mg twice daily on days 1-17.
767430|NCT01525628|E4|Reported Event|Group D|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily with probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66).
767431|NCT01525628|E3|Reported Event|Group C|600mg deleobuvir(DBV) tablet taken twice a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks with tenofovir tablet 300mg daily on days 1-17.
767432|NCT01525628|E2|Reported Event|Group B|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a (PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group B the effect of FDV on DBV, the effect of DBV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767433|NCT01525628|E1|Reported Event|Group A|600mg deleobuvir(DBV) tablet taken orally 3 times a day plus 120mg faldaprevir(FDV) capsule taken orally once daily plus ribavirin(RBV) tablet taken orally twice daily for 24 weeks along with pegylated interferon α-2a(PegIFN) injection and probe drugs(200 mg caffeine tablet, 500 mg tolbutamide tablet, and 2 mg midazolam syrup administered orally on days 1, 9, 17, and 66). In group A the effect of DBV on FDV, the effect of FDV, dual oral direct acting antiviral (DAAs) and their metabolites on caffeine, tolbutamide and midazolam were determined.
767434|NCT01525615|B4|Baseline|Total|Total of all reporting groups
767435|NCT01525615|B3|Baseline|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767436|NCT01525615|B2|Baseline|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767437|NCT01525615|B1|Baseline|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767438|NCT01525615|P3|Participant Flow|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767439|NCT01525615|P2|Participant Flow|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767587|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767442|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767443|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767444|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767445|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767446|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767447|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767448|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767449|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767450|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767451|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767452|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767453|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
814928|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
767454|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767455|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767456|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767457|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767458|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767459|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767460|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767461|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767462|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767463|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767464|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767465|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767466|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767467|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767468|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767469|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767470|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767471|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767472|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767473|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767588|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767474|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767475|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767476|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767477|NCT01525615|O3|Outcome|Tio+Olo 5.0 / 5.0 µg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767478|NCT01525615|O2|Outcome|Tio+Olo 2.5 / 5.0 µg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767479|NCT01525615|O1|Outcome|Placebo|"once daily 2 puffs, solution for inhalation Respimat~placebo to tiotropium+olodaterol: comparator"
767480|NCT01525615|E3|Reported Event|Tio+Olo 5.0 / 5.0 μg|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767481|NCT01525615|E2|Reported Event|Tio+Olo 2.5 / 5.0 μg|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
767482|NCT01525615|E1|Reported Event|Placebo|once daily 2 puffs, solution for inhalation Respimat placebo to tiotropium+olodaterol: comparator
767483|NCT01525563|B1|Baseline|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
767484|NCT01525563|P1|Participant Flow|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
767485|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
767486|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
767487|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
767488|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
767489|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
767490|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
767491|NCT01525563|O1|Outcome|Subjects With Irregular Menstrual Cycle|All patients who had received at least one dose of treatment and had at least one efficacy assessment to assess cycle regularization during the end of treatment period.
767492|NCT01525563|E1|Reported Event|Subjects With Irregular Menstrual Cycle|Adult subjects with irregular menstrual cycle and can be treated with Duphaston as per locally approved label can be enrolled.
767493|NCT01525550|B3|Baseline|Total|Total of all reporting groups
767494|NCT01525550|B2|Baseline|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767495|NCT01525550|B1|Baseline|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767496|NCT01525550|P2|Participant Flow|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767497|NCT01525550|P1|Participant Flow|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767498|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767499|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767500|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767501|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767589|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767590|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767502|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767503|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767504|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767505|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767506|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767507|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767508|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767509|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767618|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767510|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767511|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767512|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767513|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767514|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767515|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767516|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767517|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767518|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767519|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767520|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767521|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767522|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767523|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767591|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767524|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767525|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767526|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767527|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767528|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767529|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767530|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767531|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767532|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767533|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767534|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767535|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767536|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767537|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767538|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767539|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767540|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767541|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767542|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767543|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767544|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767545|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767592|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767546|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767547|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767548|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767549|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767550|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767551|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767552|NCT01525550|O2|Outcome|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767553|NCT01525550|O1|Outcome|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767554|NCT01525550|E2|Reported Event|Sunitinib: Later-Line Cohort|Sunitinib 37.5 mg capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in previously treated/later-line participants (participants who developed progressive disease on or after prior systemic therapy).
767555|NCT01525550|E1|Reported Event|Sunitinib: Treatment Naive Cohort|Sunitinib 37.5 milligram (mg) capsule, orally once daily in each 28-day treatment cycle (up to a maximum of 43 cycles) until death, unacceptable toxicity, consent withdrawal or final analysis in treatment-naive participants.
767556|NCT01525420|B3|Baseline|Total|Total of all reporting groups
767557|NCT01525420|B2|Baseline|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): ACT: This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
767558|NCT01525420|B1|Baseline|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
767559|NCT01525420|P2|Participant Flow|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT~This is the control arm of the study. This included 5 weekly sessions of CBT therapy via telephone."
767560|NCT01525420|P1|Participant Flow|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT~This is the experimental arm of the study. This included 5 weekly sessions of ACT therapy via telephone."
767561|NCT01525420|O2|Outcome|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
767562|NCT01525420|O1|Outcome|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
767563|NCT01525420|E2|Reported Event|Cognitive Behavioral Therapy (CBT)|"CBT~Cognitive Behavioral Therapy (CBT): CBT"
767564|NCT01525420|E1|Reported Event|Acceptance & Commitment Therapy (ACT)|"ACT~Acceptance & Commitment Therapy (ACT): ACT"
767565|NCT01525238|B4|Baseline|Total|Total of all reporting groups
767566|NCT01525238|B3|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767567|NCT01525238|B2|Baseline|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767568|NCT01525238|B1|Baseline|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767569|NCT01525238|P3|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767570|NCT01525238|P2|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767571|NCT01525238|P1|Participant Flow|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767572|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767573|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767574|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767575|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767576|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767577|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767578|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767579|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767580|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767581|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767582|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767583|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767584|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767585|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767586|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767594|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767595|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767596|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767597|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767598|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767599|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767600|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767601|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767602|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767603|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767604|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767605|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767606|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767607|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767608|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767609|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767610|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767611|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767612|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767613|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767614|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767615|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767616|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767621|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767622|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767623|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767624|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767625|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767626|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767627|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767628|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767629|NCT01525238|O3|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767630|NCT01525238|O2|Outcome|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767631|NCT01525238|O1|Outcome|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767632|NCT01525238|E3|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablet, Oral, 10 mg, Single-dose
767633|NCT01525238|E2|Reported Event|Dapagliflozin 5 mg|Dapagliflozin: Tablet, Oral, 5 mg, Single-dose
767634|NCT01525238|E1|Reported Event|Dapagliflozin 2.5 mg|Dapagliflozin: Tablet, Oral, 2.5 mg, Single-dose
767635|NCT01525225|B1|Baseline|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
767636|NCT01525225|P1|Participant Flow|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® immediate release (IR) tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin extended release (XR) fixed dose combination (FDC) tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
767637|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
767638|NCT01525225|O1|Outcome|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
767674|NCT01524900|B3|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767675|NCT01524900|B2|Baseline|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
777594|NCT01482221|E3|Reported Event|Placebo|Intravenous infusion
767639|NCT01525225|E1|Reported Event|Metformin + Saxagliptin + Saxagliptin/Metformin XR FDC|Each participant received one dose of a 5 mg saxagliptin tablet once a day (QD) and a 1000 mg Glucophage® IR tablet twice a day (BID) on Day 1. On Days 2 through 6, participants received a 1000 mg tablet of Glucophage® IR BID, and on Day 7, participants received one dose of two 2.5 mg saxagliptin/1000 mg metformin XR FDC tablets. Finally, on Day 8 participants received four 500 mg Glucophage® IR tablets QD. All study drugs were administered with food.
767640|NCT01525173|B3|Baseline|Total|Total of all reporting groups
767641|NCT01525173|B2|Baseline|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767642|NCT01525173|B1|Baseline|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767643|NCT01525173|P2|Participant Flow|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767644|NCT01525173|P1|Participant Flow|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767645|NCT01525173|O2|Outcome|LUMIGAN® Alone|1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767646|NCT01525173|O1|Outcome|ALPHAGAN® P and LUMIGAN®|1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767647|NCT01525173|E2|Reported Event|LUMIGAN® Alone|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767692|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767897|NCT01523743|E2|Reported Event|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
767648|NCT01525173|E1|Reported Event|ALPHAGAN® P and LUMIGAN®|1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
767649|NCT01524913|B4|Baseline|Total|Total of all reporting groups
767650|NCT01524913|B3|Baseline|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
767651|NCT01524913|B2|Baseline|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
767652|NCT01524913|B1|Baseline|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
767653|NCT01524913|P3|Participant Flow|Saline Placebo|Participants in this group received 1 milliliter (mL) of lactated Ringer's solution injected into the superior joint space.
767654|NCT01524913|P2|Participant Flow|Hyaluronic Acid|Participants in the group received 1milliliter (mL) of Hyalgan (10 mg/mL) injected into the superior joint space.
767655|NCT01524913|P1|Participant Flow|Corticosteroid|Participants in this group received 1 milliliter (mL) of Celestone (6mg/mL) injected into the the superior joint space.
767656|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
767657|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
767658|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
767659|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
767660|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
767661|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
767662|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
767663|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
767664|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
767665|NCT01524913|O3|Outcome|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
767666|NCT01524913|O2|Outcome|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
767667|NCT01524913|O1|Outcome|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
767668|NCT01524913|E3|Reported Event|Saline Placebo|Participants in this group received 1mL of lactated Ringer's solution injected into the superior joint space.
767669|NCT01524913|E2|Reported Event|Hyaluronic Acid|Participants in the group received 1mL of Hyalgan (10 mg/mL) injected into the superior joint space.
767670|NCT01524913|E1|Reported Event|Corticosteroid|Participants in this group received 1mL of Celestone (6mg/mL) injected into the the superior joint space.
767671|NCT01524900|B6|Baseline|Total|Total of all reporting groups
767672|NCT01524900|B5|Baseline|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767673|NCT01524900|B4|Baseline|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767676|NCT01524900|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767677|NCT01524900|P5|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767678|NCT01524900|P4|Participant Flow|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767679|NCT01524900|P3|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767680|NCT01524900|P2|Participant Flow|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767681|NCT01524900|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767682|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767683|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767684|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767685|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767686|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767687|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767688|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load>50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767689|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767690|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767691|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767693|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767694|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767695|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767696|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767697|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767698|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767699|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767700|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767701|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767702|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767703|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767704|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767705|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767706|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767707|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767708|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767709|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767710|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767711|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767712|NCT01524900|O5|Outcome|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767713|NCT01524900|O4|Outcome|Pretreated Patients, Baseline Viral Load >50 Copies/mL|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767714|NCT01524900|O3|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
777595|NCT01482221|E2|Reported Event|AZD6765iv 50 mg|Intravenous infusion
767715|NCT01524900|O2|Outcome|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767716|NCT01524900|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy
767717|NCT01524900|E5|Reported Event|Patients With Baseline Viral Load Not Documented|Patients with no documented information about the baseline viral load.
767718|NCT01524900|E4|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/ML|Patients switching from a virologically ineffective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load > 50 copies/mL.
767719|NCT01524900|E3|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/ML|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance) other than nevirapine IR, with a baseline viral load ≤ 50 copies/mL.
767720|NCT01524900|E2|Reported Event|Patients Switching From Nevirapine IR|Patients switching from nevirapine immediate release (IR).
767721|NCT01524900|E1|Reported Event|Treatment-naïve Patients|Patients who were not pretreated with HIV therapy
767722|NCT01524887|B4|Baseline|Total|Total of all reporting groups
767723|NCT01524887|B3|Baseline|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767724|NCT01524887|B2|Baseline|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767725|NCT01524887|B1|Baseline|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767726|NCT01524887|P3|Participant Flow|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767727|NCT01524887|P2|Participant Flow|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767728|NCT01524887|P1|Participant Flow|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767729|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767730|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767731|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767732|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
814929|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
767733|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767734|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767735|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767736|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767737|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767738|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767739|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767740|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767741|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767742|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767743|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767744|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767745|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767746|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767747|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767748|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767749|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767750|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767751|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767752|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767753|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767754|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767755|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767756|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767757|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767758|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767759|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767760|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767761|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767762|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767763|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767764|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767765|NCT01524887|O3|Outcome|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767766|NCT01524887|O2|Outcome|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767767|NCT01524887|O1|Outcome|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767768|NCT01524887|E3|Reported Event|Placebo Control|Human albumin 0.25%: Intravenous infusion every 2 weeks over 18 months
767769|NCT01524887|E2|Reported Event|IGIV, 10% at Low Dose (0.2 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767770|NCT01524887|E1|Reported Event|IGIV, 10% at High Dose (0.4 g/kg)|Immune Globulin Intravenous (Human), 10% Solution: Intravenous infusion every 2 weeks over 18 months
767771|NCT01524796|B1|Baseline|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767772|NCT01524796|P1|Participant Flow|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767773|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767774|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767896|NCT01523743|O1|Outcome|Compact Catheter|Compact intermittent catheter
767775|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767776|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767777|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767778|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767779|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767780|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767781|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767782|NCT01524796|O1|Outcome|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767783|NCT01524796|E1|Reported Event|Pregabalin|Participants who were diagnosed with peripheral neuropathic pain and met the usual prescribing criteria for pregabalin (Lyrica) as per the local product information were observed for a period of 3 months.
767784|NCT01524783|B3|Baseline|Total|Total of all reporting groups
767785|NCT01524783|B2|Baseline|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767786|NCT01524783|B1|Baseline|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767787|NCT01524783|P2|Participant Flow|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767788|NCT01524783|P1|Participant Flow|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767789|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767790|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767791|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767792|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767793|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767794|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767795|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767836|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
767796|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767797|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767798|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767799|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767800|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767801|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767802|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767803|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767804|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767805|NCT01524783|O2|Outcome|Everolimus Placebo + BSC|Participants received matching placebo to everolimus with same dose, plus best supportive care (BSC)
767806|NCT01524783|O1|Outcome|Everolimus + BSC|Participants received everolimus 10mg once daily until disease progression, intolerable toxicity, or consent withdrawal, plus best supportive care (BSC)
767807|NCT01524783|E2|Reported Event|Placebo + BSC|Placebo + BSC
767808|NCT01524783|E1|Reported Event|Everolimus + BSC|Everolimus + BSC
767809|NCT01524770|B1|Baseline|Entire Study Population|All participants who received at least one 1.5-milligram (mg) dose of dulaglutide administered subcutaneously via manual syringe or auto-injector.
767810|NCT01524770|P2|Participant Flow|Auto-injector First, Then Manual Syringe|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by manual syringe."
767811|NCT01524770|P1|Participant Flow|Manual Syringe First, Then Auto-injector|"First Intervention:~Dulaglutide: A single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe.~There was a washout period of at least 28 days between treatment periods.~Second intervention:~Dulaglutide: A single dose of 1.5 mg dulaglutide administered SC by auto-injector."
767812|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
767813|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
767814|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
767815|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
767816|NCT01524770|O2|Outcome|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
767817|NCT01524770|O1|Outcome|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period.
767818|NCT01524770|E2|Reported Event|Manual Syringe|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by manual syringe in one of two study periods separated by a 28 day minimum washout period.
767819|NCT01524770|E1|Reported Event|Auto-injector|Dulaglutide: Single dose of 1.5 milligrams (mg) dulaglutide administered subcutaneously (SC) by auto-injector in one of two study periods separated by a minimum 28 day washout period
767820|NCT01524302|B3|Baseline|Total|Total of all reporting groups
767821|NCT01524302|B2|Baseline|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
767822|NCT01524302|B1|Baseline|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
767823|NCT01524302|P2|Participant Flow|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
767824|NCT01524302|P1|Participant Flow|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
767825|NCT01524302|O4|Outcome|Log Inhibition of 4.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
767826|NCT01524302|O3|Outcome|Log Inhibition of 2.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
767827|NCT01524302|O2|Outcome|Log Inhibition of 1.0mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
767828|NCT01524302|O1|Outcome|Log Inhibition of 0.5mg/L MIC Levofloxacin|Measurement of the decrease in organism (Staphylococcus aureus) colony counts following exposure of serum containing Levofloxacin or Ceftaroline
767829|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
767830|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
767831|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
767832|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
767833|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
767834|NCT01524302|O1|Outcome|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
767835|NCT01524302|O2|Outcome|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
767837|NCT01524302|E2|Reported Event|Ceftaroline|"Pharmacodynamics~Ceftaroline: 600 mg Q12h"
767838|NCT01524302|E1|Reported Event|Levofloxacin|"Pharmacodynamics~Levofloxacin: 750 mg QD"
767839|NCT01524198|B3|Baseline|Total|Total of all reporting groups
767840|NCT01524198|B2|Baseline|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
767841|NCT01524198|B1|Baseline|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
767842|NCT01524198|P2|Participant Flow|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
767843|NCT01524198|P1|Participant Flow|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
767844|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
767845|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
767846|NCT01524198|O2|Outcome|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
767847|NCT01524198|O1|Outcome|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
767848|NCT01524198|E2|Reported Event|Budesonide, Albuterol, Ipratropium Bromide|Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if < 20 kg body weight or 5 mg if >= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
767849|NCT01524198|E1|Reported Event|Normal Saline, Albuterol, Ipratropium Bromide|Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if < 20 kg or 5 mg if >= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back
767850|NCT01523964|B5|Baseline|Total|Total of all reporting groups
767851|NCT01523964|B4|Baseline|Healthy Control Ages 8-12 Inclusive|
767852|NCT01523964|B3|Baseline|Healthy Control Ages 3-7 Inclusive|
767853|NCT01523964|B2|Baseline|DMD Subject Ages 8-12 Inclusive|
767854|NCT01523964|B1|Baseline|DMD Subject Ages 3-7 Inclusive|
767855|NCT01523964|P4|Participant Flow|Healthy Control Ages 8-12 Inclusive|
767856|NCT01523964|P3|Participant Flow|Healthy Control Ages 3-7 Inclusive|
767857|NCT01523964|P2|Participant Flow|DMD Subject Ages 8-12 Inclusive|
767858|NCT01523964|P1|Participant Flow|DMD Subject Ages 3-7 Inclusive|
767859|NCT01523964|O4|Outcome|Healthy Control Ages 8-12 Inclusive|
767860|NCT01523964|O3|Outcome|Healthy Control Ages 3-7 Inclusive|
767861|NCT01523964|O2|Outcome|DMD Subject Ages 8-12 Inclusive|
767862|NCT01523964|O1|Outcome|DMD Subject Ages 3-7 Inclusive|
767863|NCT01523964|E4|Reported Event|Healthy Control Ages 8-12 Inclusive|
767864|NCT01523964|E3|Reported Event|Healthy Control Ages 3-7 Inclusive|
767865|NCT01523964|E2|Reported Event|DMD Subject Ages 8-12 Inclusive|
767866|NCT01523964|E1|Reported Event|DMD Subject Ages 3-7 Inclusive|
767867|NCT01523886|B3|Baseline|Total|Total of all reporting groups
767868|NCT01523886|B2|Baseline|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
767869|NCT01523886|B1|Baseline|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
767870|NCT01523886|P2|Participant Flow|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
767871|NCT01523886|P1|Participant Flow|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
767872|NCT01523886|O2|Outcome|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
767873|NCT01523886|O1|Outcome|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
767874|NCT01523886|E2|Reported Event|Moderate Neuromuscular Blockade|Rocuronium: Intravenous use: 0,3 mg/kg followed by NaCl-infusion
767875|NCT01523886|E1|Reported Event|Deep Neuromuscular Blockade|Rocuronium: Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
767876|NCT01523873|B1|Baseline|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
767877|NCT01523873|P1|Participant Flow|All Included Patients|All patients scheduled for a Dotarem-enhanced MRI with appropriate consent, prospectively enrolled in the study and having reliable data reported.
767878|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
767879|NCT01523873|O1|Outcome|Efficacy Population|Efficacy Population included all patients administered with Dotarem who have been imaged and have had a valid diagnostic assessment.
767880|NCT01523873|O1|Outcome|Patients With Moderate to Severe Impaired Renal Function|Patients identified with moderate to severe impaired renal function at the time of inclusion (i.e. estimated Glomerular Filtration Rate (eGFR) or estimated creatinine clearance (eCrCl) <60 ml/min (1.73 m2))
767881|NCT01523873|O1|Outcome|Safety Population|Safety Population included All Included Patients administered with Dotarem.
767882|NCT01523873|E1|Reported Event|Safety Population|Safety Population included All Included Patients administered with Dotarem.
767883|NCT01523756|B1|Baseline|Overall Study|
767884|NCT01523756|P2|Participant Flow|Own Product (Baseline) - Test Product 2 - Test Product 1|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
767885|NCT01523756|P1|Participant Flow|Own Product (Baseline) - Test Product 1 - Test Product 2|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
767886|NCT01523756|O3|Outcome|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
767887|NCT01523756|O2|Outcome|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
767888|NCT01523756|O1|Outcome|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
767889|NCT01523756|E3|Reported Event|Baseline|"Data collected on own product-~All subjects collected baseline data on own product in the first period."
767890|NCT01523756|E2|Reported Event|Test Product 2|"own product (baseline) - test product 2 - test product 1~test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2"
767891|NCT01523756|E1|Reported Event|Test Product 1|"own product (baseline) - test product 1 - test product 2~test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1"
767892|NCT01523743|B1|Baseline|All Study Participants|"125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data.~The baseline and analysis data are based on the ITT population."
767893|NCT01523743|P2|Participant Flow|First Standard Care; Then Compact Catheter|First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast
767894|NCT01523743|P1|Participant Flow|First Compact Catheter, Then Standard Care|First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject
767895|NCT01523743|O2|Outcome|Standard Care|Standard Care: Coated intermittent catheter normally used by subject
767898|NCT01523743|E1|Reported Event|Compact Catheter|Compact intermittent catheter
767899|NCT01523587|B3|Baseline|Total|Total of all reporting groups
767900|NCT01523587|B2|Baseline|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767901|NCT01523587|B1|Baseline|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767902|NCT01523587|P2|Participant Flow|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767903|NCT01523587|P1|Participant Flow|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767904|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767905|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767906|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767907|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767908|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767909|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767910|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767911|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767912|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767913|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767914|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767915|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767916|NCT01523587|O2|Outcome|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767917|NCT01523587|O1|Outcome|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767918|NCT01523587|E2|Reported Event|Erlotinib Once Daily|150 mg once daily, with dose reduction to 100 mg/day or 50 mg/day in the presence of known drug-related adverse events.
767919|NCT01523587|E1|Reported Event|Afatinib Once Daily|40 mg once daily for the first 28-day treatment course. Dose escalation to 50 mg once daily was allowed at the beginning of the second 28-day treatment course, if patients met specified safety and compliance criteria. Dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day, was required in the presence of known drug-related adverse events.
767920|NCT01523392|B3|Baseline|Total|Total of all reporting groups
767921|NCT01523392|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
767922|NCT01523392|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 2)
767923|NCT01523392|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), and then ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 2)
767924|NCT01523392|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2)
767925|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767926|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767927|NCT01523392|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767928|NCT01523392|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767929|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
767930|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767931|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
767932|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767933|NCT01523392|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
767934|NCT01523392|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767935|NCT01523392|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days
767936|NCT01523392|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767937|NCT01523366|B3|Baseline|Total|Total of all reporting groups
767938|NCT01523366|B2|Baseline|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
767939|NCT01523366|B1|Baseline|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
767940|NCT01523366|P2|Participant Flow|Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
767941|NCT01523366|P1|Participant Flow|Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence|Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
767942|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767943|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767944|NCT01523366|O2|Outcome|Ticagrelor (Treatment Period 2)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767945|NCT01523366|O1|Outcome|Ticagrelor (Treatment Period 1)|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days
767946|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
767947|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
767948|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
767949|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
767950|NCT01523366|O2|Outcome|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
767951|NCT01523366|O1|Outcome|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
767952|NCT01523366|E2|Reported Event|Clopidogrel Arm|Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days.
767953|NCT01523366|E1|Reported Event|Ticagrelor Arm|Ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days.
767954|NCT01523301|B3|Baseline|Total Title|
767955|NCT01523301|B2|Baseline|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
767956|NCT01523301|B1|Baseline|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
767957|NCT01523301|P2|Participant Flow|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
767998|NCT01522976|E2|Reported Event|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
768323|NCT01521845|E2|Reported Event|Control|This group is without omega 3 : just receives standard treatment
767958|NCT01523301|P1|Participant Flow|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
767959|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767960|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767961|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767962|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767963|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767964|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767965|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767966|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767967|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767968|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
768041|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
767969|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767970|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767971|NCT01523301|O2|Outcome|Efficacy Evaluable Set (Placebo Treated Subjects)|Placebo, daily doses, placebo Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767972|NCT01523301|O1|Outcome|Efficacy Evaluable Set (Rotigotine Treated Subjects)|Rotigotine, daily doses, treatment Group. The Efficacy Evaluable Set (EES) consisted of all subjects who received at least one dose of study medication, had a valid Baseline and at least 1 valid post-Baseline HAM-D 17 measurement and who had a Baseline HAM-D 17 score of 12 or higher.
767973|NCT01523301|E2|Reported Event|Placebo|"Placebo, daily doses, placebo Group. Subjects randomized to placebo received matching placebo patches.~Early-stage Parkinson´s disease for 1 week: Placebo patches´ dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Placebo patches´dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period.~In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
767999|NCT01522976|E1|Reported Event|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Lenalidomide: Given PO
768324|NCT01521845|E1|Reported Event|Omega 3|receive omega 3 in addition to standard treatment
767974|NCT01523301|E1|Reported Event|Rotigotine|"Rotigotine, daily doses, treatment Group.~Early-stage Parkinon´s disease for 1 week: Rotigotine dose at 2 mg/24 h. Advanced-stage Parkinson´s disease for 1 week: Rotigotine dose at 4 mg/24 h.~Afterwards the dose has been increased in the Titration Period by 2 mg/24 h each week until either the optimal or maximal dose was reached.~All subjects remained 8-weeks in the Maintenance Period. In the De-escalation Period Subjects with early-stage Parkinson´s disease de-escalated their dose by 2 mg/24 h every other day to 2 mg/24h, and then to 0 mg after 2 days. Subjects with advanced-stage Parkinson´s disease de-escalated their dose by 2 mg/24h every other day to 4 mg/24h, and then to 0 mg after 2 days.~A Safety Follow-Up Visit was scheduled for all subjects 30 days after their last dose administration."
767975|NCT01522976|B4|Baseline|Total|Total of all reporting groups
767976|NCT01522976|B3|Baseline|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
767977|NCT01522976|B2|Baseline|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
767978|NCT01522976|B1|Baseline|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
767979|NCT01522976|P3|Participant Flow|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
767980|NCT01522976|P2|Participant Flow|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
767981|NCT01522976|P1|Participant Flow|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
767982|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
767983|NCT01522976|O2|Outcome|Arm 2: Azacitidine|Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
767984|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV
767985|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
767986|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
767987|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
767988|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
767989|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
768453|NCT01521026|P2|Participant Flow|Standard Pharmacotherapy|Standard pharmacotherapy with regular clinician
767990|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
767991|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
767992|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
767993|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
767994|NCT01522976|O3|Outcome|Arm 3: Azacitidine/Vorinostat|"Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Vorinostat: Given PO"
767995|NCT01522976|O2|Outcome|Arm 2: Azacitidine|"Patients receive azacitidine as in Arm 1. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV"
767996|NCT01522976|O1|Outcome|Arm 1: Azacitidine/Lenalidomide|"Patients receive azacitidine SC or IV on days 1-7 or days 1-5 and 8-9, and lenalidomide PO QD on days 1-21. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity.~Azacitidine: Given SC or IV~Lenalidomide: Given PO"
767997|NCT01522976|E3|Reported Event|Arm 3: Azacitidine/Vorinostat|Patients receive azacitidine as in Arm 1 and vorinostat PO BID on days 3-9. Courses repeat every 28 days for up to 5 years in the absence of disease progression or unacceptable toxicity. Azacitidine: Given SC or IV Vorinostat: Given PO
768000|NCT01522937|B1|Baseline|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768001|NCT01522937|P1|Participant Flow|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768002|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768003|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768004|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768005|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768454|NCT01521026|P1|Participant Flow|Cognitive Training|Cognitive training group
768006|NCT01522937|O1|Outcome|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768007|NCT01522937|E1|Reported Event|Liver Cancer Patients|"The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).~individualized Stereotactic Body Radiation Therapy (SBRT): The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment."
768008|NCT01522924|B3|Baseline|Total|Total of all reporting groups
768009|NCT01522924|B2|Baseline|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768010|NCT01522924|B1|Baseline|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768011|NCT01522924|P2|Participant Flow|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768012|NCT01522924|P1|Participant Flow|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768013|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768014|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768015|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768016|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768017|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768018|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768019|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768020|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768021|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768022|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768023|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768024|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768025|NCT01522924|O2|Outcome|Lecture Only|Students will receive the first questionnaire before the lecture and the second questionnaire after the lecture
768026|NCT01522924|O1|Outcome|Counseling Practice Sessions|Dental students will be administered the first questionnaire before receiving a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients, and debriefing session.
768027|NCT01522924|E2|Reported Event|Counseling/Debriefing|participated in counseling and debriefing sessions
768028|NCT01522924|E1|Reported Event|Lecture Only|participated in lecture only
768029|NCT01522703|B3|Baseline|Total|Total of all reporting groups
768030|NCT01522703|B2|Baseline|Alfalfa Sprouts (Placebo Control)|
768031|NCT01522703|B1|Baseline|Broccoli Sprouts|
768032|NCT01522703|P2|Participant Flow|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts 3 consecutive days
768033|NCT01522703|P1|Participant Flow|Broccoli Sprouts|ingestion of broccoli sprouts 3 consecutive days
768034|NCT01522703|O2|Outcome|Broccoli Sprouts|ingestion of broccoli sprouts for 3 consecutive days
768035|NCT01522703|O1|Outcome|Alfalfa Sprouts (Placebo Control)|ingestion of alfalfa sprouts for 3 consecutive days
768036|NCT01522703|E2|Reported Event|Alfalfa Sprouts (Placebo Control)|
768037|NCT01522703|E1|Reported Event|Broccoli Sprouts|
768038|NCT01522456|B1|Baseline|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
768039|NCT01522456|P1|Participant Flow|Total Participants|All subjects randomized into the trial who received Epiduo Gel and Retin-A Micro 0.1% gel on each side of the face
768040|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768042|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768043|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768044|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768045|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768046|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768047|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768048|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768049|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768050|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768051|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768052|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768053|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768325|NCT01521780|B1|Baseline|All Participants|Participants who enrolled in the study
768054|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768055|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768056|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768057|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768058|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768059|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768060|NCT01522456|O4|Outcome|Retin-A Micro (Fitzpatrick Skin Types IV-VI)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768061|NCT01522456|O3|Outcome|Epiduo Gel (Fitzpatrick Skin Types IV-VI)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768062|NCT01522456|O2|Outcome|Retin-A Micro (Fitzpatrick Skin Types I-III)|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768063|NCT01522456|O1|Outcome|Epiduo Gel (Fitzpatrick Skin Types I-III)|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768064|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768065|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768066|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768067|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768068|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768069|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768070|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768071|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768072|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768073|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768455|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
768074|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768075|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768076|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768077|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768078|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768079|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768080|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768081|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768082|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768083|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768084|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768085|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768086|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
769564|NCT01518192|O2|Outcome|Cefuroximew Axetil|cefuroxime axetil 500 mg twice daily for 15 days
768087|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768088|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768089|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768090|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768091|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768092|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768093|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768094|NCT01522456|O2|Outcome|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768095|NCT01522456|O1|Outcome|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768096|NCT01522456|E3|Reported Event|Non-application Site|Adverse events occurring on non-application sites
768097|NCT01522456|E2|Reported Event|Retin-A Micro Microsphere 0.1%|"Tretinoin gel, 0.1%~Retin-A Micro Microsphere 0.1% : Tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel."
768098|NCT01522456|E1|Reported Event|Epiduo Gel|"Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% gel~Epiduo Gel : Fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel."
768099|NCT01522339|B1|Baseline|Pilot Group|Patients who had an MRI in the NICU scanner.
768100|NCT01522339|P1|Participant Flow|Pilot Group|Patients who received an MRI.
768101|NCT01522339|O1|Outcome|Pilot Group|Patients who had an MRI on the NICU scanner.
768102|NCT01522339|O1|Outcome|Pilot Group|Patients who received an MRI on the NICU scanner.
768103|NCT01522339|E1|Reported Event|Pilot Group|Patients who had an MRI in the NICU scanner.
768104|NCT01522131|B3|Baseline|Total|Total of all reporting groups
768105|NCT01522131|B2|Baseline|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
768106|NCT01522131|B1|Baseline|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
768107|NCT01522131|P2|Participant Flow|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
768108|NCT01522131|P1|Participant Flow|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
768109|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
768198|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768110|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
768111|NCT01522131|O2|Outcome|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
768112|NCT01522131|O1|Outcome|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
768113|NCT01522131|E2|Reported Event|Laser With Bioresorabable Membrane (Test)|bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
768114|NCT01522131|E1|Reported Event|Bioresorbable Membrane Will be Used as the Control|"Bioresorbable membrane (control)~bioresorbable membrane with laser will be used for regeneration of the periodontium: bioresorbable membrane with laser will be used for regeneration of the periodontium(test)"
768115|NCT01521923|B5|Baseline|Total Title|
768116|NCT01521923|B4|Baseline|CZP+MTX / CZP Q2W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2
768117|NCT01521923|B3|Baseline|CZP+MTX / CZP Q4W+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2
768118|NCT01521923|B2|Baseline|CZP+MTX / PBO+MTX|Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
768119|NCT01521923|B1|Baseline|PBO+MTX / PBO+MTX|Placebo (PBO) + Methotrexate (MTX) in Period 11 syringe PBO every 2 Weeks + MTX in Period 2
768120|NCT01521923|P4|Participant Flow|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768178|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768121|NCT01521923|P3|Participant Flow|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768122|NCT01521923|P2|Participant Flow|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768123|NCT01521923|P1|Participant Flow|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768124|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768125|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768126|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768127|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768128|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768129|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768130|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768131|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768132|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768133|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768134|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768135|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768136|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768137|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768138|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768139|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768228|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768140|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768141|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768142|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768143|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768144|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768145|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768146|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768147|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768148|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768285|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
814930|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
768149|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768150|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768151|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768152|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768153|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768154|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768155|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768156|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768157|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768158|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768159|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768160|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768161|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768162|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768163|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768164|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768165|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768166|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768167|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768168|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768456|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
768169|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768170|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768171|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768172|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768173|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768174|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768175|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768176|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768177|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768179|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768180|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768181|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768182|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768183|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768184|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768185|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768186|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768187|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768188|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768189|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768190|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768191|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768192|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768193|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768194|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768195|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768196|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768197|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
777596|NCT01482221|E1|Reported Event|AZD6765iv 100 mg|Intravenous infusion
768199|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768200|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768201|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768202|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768203|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768204|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768205|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768206|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768207|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768208|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768209|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768210|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768211|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768212|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768213|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768214|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768215|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768216|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768217|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768218|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768219|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768220|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768221|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768222|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768223|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768224|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768225|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768226|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768227|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768457|NCT01521026|O2|Outcome|Standard Pharmacotherapy|Standard pharmacotherapy with the regular clinician
768229|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768230|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768231|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Radiographic Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768232|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768233|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768234|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768235|NCT01521923|O3|Outcome|CZP+MTX / CZP Q2W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768236|NCT01521923|O2|Outcome|CZP+MTX / CZP Q4W+MTX (Full Analysis Set)|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768237|NCT01521923|O1|Outcome|CZP+MTX / PBO+MTX (Full Analysis Set [FAS])|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768238|NCT01521923|E4|Reported Event|CZP+MTX / CZP Q2W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 2 Weeks + MTX in Period 2"
768239|NCT01521923|E3|Reported Event|CZP+MTX / CZP Q4W+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe 200 mg Certolizumab pegol (CZP) every 4 Weeks/ 1 syringe Placebo (PBO) every 4 Weeks (CZP and PBO administration to be staggered 2 weeks apart to maintain blind) + MTX in Period 2"
768240|NCT01521923|E2|Reported Event|CZP+MTX / PBO+MTX|"Certolizumab pegol (CZP) 200 mg Q2W + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768241|NCT01521923|E1|Reported Event|PBO+MTX / PBO+MTX|"Placebo (PBO) + Methotrexate (MTX) in Period 1~1 syringe PBO every 2 Weeks + MTX in Period 2"
768242|NCT01521897|B1|Baseline|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768243|NCT01521897|P1|Participant Flow|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768244|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768245|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768246|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768247|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768248|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768249|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768250|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768251|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768305|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768252|NCT01521897|O1|Outcome|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768253|NCT01521897|E1|Reported Event|Prevenar™ (7-valent)|Participants were vaccinated with Prevenar™ (7-valent) as follows: for primary immunization, three doses of Prevenar™ (7-valent) 0.5 mL were injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar™ (7-valent) 0.5 mL was injected subcutaneously, at least 60 days after the third dose.
768254|NCT01521884|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768255|NCT01521884|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768256|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768257|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768258|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768321|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
768259|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768260|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768261|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768262|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768263|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768264|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768265|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768266|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768267|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768268|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768269|NCT01521884|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768270|NCT01521884|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who received subcutaneous anti-TNF-alpha therapy along with methotrexate as per treating physician’s discretion based on summary of product characteristics, were followed up for 2 years.
768271|NCT01521871|B3|Baseline|Total|Total of all reporting groups
768272|NCT01521871|B2|Baseline|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
768273|NCT01521871|B1|Baseline|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768274|NCT01521871|P2|Participant Flow|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
768275|NCT01521871|P1|Participant Flow|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768458|NCT01521026|O1|Outcome|Cognitive Training|Cognitive training group
768276|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768277|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768278|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768279|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768280|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768281|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768282|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768283|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768284|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768322|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
768286|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768287|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768288|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768289|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768290|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768291|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768292|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768293|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768294|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768295|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768296|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768297|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768298|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768299|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768300|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768301|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768302|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768303|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768304|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
777597|NCT01482091|B3|Baseline|Total|Total of all reporting groups
768306|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768307|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768308|NCT01521871|O2|Outcome|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing: Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768309|NCT01521871|O1|Outcome|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue: The glue is used both as closure device and as wound dressing."
768310|NCT01521871|E2|Reported Event|Tissue Glue Wound Closure|"Skin wound closure by tissue glue~Skin wound closure by tissue glue : The glue is used both as closure device and as wound dressing."
768311|NCT01521871|E1|Reported Event|Conventional Suture + Dressing|"Skin wound closure by conventional suture + dressing~Skin wound closure by conventional suture + dressing : Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)"
768312|NCT01521845|B3|Baseline|Total|Total of all reporting groups
768313|NCT01521845|B2|Baseline|Control|This group is without omega 3 : just receives standard treatment
768314|NCT01521845|B1|Baseline|Omega 3|receive omega 3 in addition to standard treatment
768315|NCT01521845|P2|Participant Flow|Control|This group is without omega 3 : just receives standard treatment
768316|NCT01521845|P1|Participant Flow|Omega 3|receive omega 3 in addition to standard treatment
768317|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
768318|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
768319|NCT01521845|O2|Outcome|Control|This group is without omega 3 : just receives standard treatment
768320|NCT01521845|O1|Outcome|Omega 3|receive omega 3 in addition to standard treatment
768326|NCT01521780|P3|Participant Flow|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
768327|NCT01521780|P2|Participant Flow|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
768328|NCT01521780|P1|Participant Flow|Imaging|Magnetic resonance imaging (MRI) of Hepatocellular carcinoma (HCC) tumor.
768329|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
768330|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
768331|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
768332|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
768333|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
768334|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
768335|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
768336|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
768337|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
768338|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
768339|NCT01521780|O1|Outcome|Imaging and Imaging/Pathology|Magnetic resonance imaging (MRI) of HCC tumor.
768340|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
768341|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
768342|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
768343|NCT01521780|O3|Outcome|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
768344|NCT01521780|O2|Outcome|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
768345|NCT01521780|O1|Outcome|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
768346|NCT01521780|E3|Reported Event|Imaging/Pathology|MRI of HCC tumor, followed by pathology samples from surgical resection of HCC tumor and adjacent liver.
768347|NCT01521780|E2|Reported Event|Pathology|Pathology samples from surgical resection of HCC tumor and adjacent liver.
768348|NCT01521780|E1|Reported Event|Imaging|Magnetic resonance imaging (MRI) of HCC tumor.
768349|NCT01521559|B3|Baseline|Total|Total of all reporting groups
768350|NCT01521559|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
768351|NCT01521559|B1|Baseline|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
768352|NCT01521559|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 milligrams (mg) Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
783489|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
768353|NCT01521559|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
768354|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
768355|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
768356|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24
768357|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
768358|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
768359|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
768360|NCT01521559|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24.
768361|NCT01521559|O1|Outcome|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24.
768362|NCT01521559|E2|Reported Event|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|Participants received 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) through week 24 followed by injections every 8 weeks (2Q8) through week 48. Participants in this group could receive laser rescue at week 36.
768363|NCT01521559|E1|Reported Event|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at Baseline and then according to laser re-treatment criteria up to week 24. Participants received treatment with Intravitreal Aflibercept Injection (IAI) starting at week 24 if they met rescue criteria. Treatment with IAI once initiated was 3 initial monthly doses followed by Q8 week dosing.
768364|NCT01521546|B3|Baseline|Total|Total of all reporting groups
768365|NCT01521546|B2|Baseline|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
768366|NCT01521546|B1|Baseline|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
768367|NCT01521546|P2|Participant Flow|Eplerenone|"active study drug~eplerenone: 25mg tablet, once daily by mouth for 12 months"
768368|NCT01521546|P1|Participant Flow|Placebo|"placebo~placebo: one tablet by mouth daily for 12 months"
768369|NCT01521546|O2|Outcome|Eplerenone|eplerenone one tablet by mouth daily for 12 months
768370|NCT01521546|O1|Outcome|Placebo|placebo: one tablet by mouth daily for 12 months
768371|NCT01521546|E2|Reported Event|Eplerenone|eplerenone one tablet daily for 12 months
768372|NCT01521546|E1|Reported Event|Placebo|placebo one tablet daily for 12 months
768373|NCT01521507|B3|Baseline|Total|Total of all reporting groups
768374|NCT01521507|B2|Baseline|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
768375|NCT01521507|B1|Baseline|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
768376|NCT01521507|P2|Participant Flow|Warm Compress & Lid Hygiene, Then Crossover LipiFlow Treatment|"Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3 months in Stage 1. Then, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at crossover, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
768377|NCT01521507|P1|Participant Flow|LipiFlow Treatment|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief:~One LipiFlow Treatment - After subjects received one LipiFlow treatment at randomization, no other MGD or dry eye treatment was prescribed for the study duration.~Two LipiFlow Treatments - Subjects received a second LipiFlow treatment during Stage 2. No other MGD or dry eye treatment was prescribed for the study duration.~Combination Treatment - After subjects received one or two LipiFlow treatments, they received other MGD or dry eye treatment, as prescribed by the physician."
768378|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
768379|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
768421|NCT01521143|P1|Participant Flow|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768460|NCT01521026|E1|Reported Event|Cognitive Training|Cognitive training group
768380|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
768381|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
768382|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
768383|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
768384|NCT01521507|O4|Outcome|Warm Compress/Hygiene Arm: Combination Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at crossover) or two LipiFlow treatments followed by other MGD or dry eye treatment, as prescribed by the physician."
768385|NCT01521507|O3|Outcome|Warm Compress/Hygiene Arm: One LipiFlow Treatment Subgroup|"After 3 months of using standardized warm compress therapy and lid hygiene, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
768386|NCT01521507|O2|Outcome|LipiFlow Arm: Combination Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the Combination Treatment subgroup, subjects received one LipiFlow treatment (at randomization) followed by other MGD or dry eye treatment, as prescribed by the physician."
768480|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768387|NCT01521507|O1|Outcome|LipiFlow Arm: One LipiFlow Treatment Subgroup|"Subjects received a single, 12-minute, in-office LipiFlow treatment of both eyes after randomization in Stage 1.~In Stage 2, subjects were entered into subgroups based on the subject's assessment of adequacy of symptom relief. In the One LipiFlow Treatment subgroup, no other MGD or dry eye treatment was prescribed for the study duration."
768388|NCT01521507|O2|Outcome|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
768389|NCT01521507|O1|Outcome|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
768390|NCT01521507|E3|Reported Event|Crossover LipiFlow Treatment|After using twice-daily, standardized warm compress therapy and lid hygiene for 3 months, subjects received a single, 12-minute crossover LipiFlow treatment of both eyes.
768391|NCT01521507|E2|Reported Event|Warm Compress & Lid Hygiene|Subjects received twice-daily, standardized warm compress therapy and lid hygiene in both eyes from randomization to 3-month visit in Stage 1.
768392|NCT01521507|E1|Reported Event|LipiFlow Treatment|Subjects received a single, 12-minute, in-office treatment of both eyes for MGD with the LipiFlow System after randomization in Stage 1 of study.
768393|NCT01521364|B1|Baseline|Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768394|NCT01521364|P1|Participant Flow|0mg, 250mg and 500mg Claritromycin|Patients receive 300mg linezolid twice a day during entire study.
768395|NCT01521364|O3|Outcome|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768396|NCT01521364|O2|Outcome|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768397|NCT01521364|O1|Outcome|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768398|NCT01521364|O3|Outcome|500mg Clarithromycin|
768399|NCT01521364|O2|Outcome|250mg Clarithromycin|
768422|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768459|NCT01521026|E2|Reported Event|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
768400|NCT01521364|O1|Outcome|0mg Claritrhomycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768401|NCT01521364|E3|Reported Event|500mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768402|NCT01521364|E2|Reported Event|250mg Clarithromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768403|NCT01521364|E1|Reported Event|0mg Claritromycin|"Patients receive 300mg linezolid twice a day during entire study. After one week, 250mg claritromycin once daily is added for a duration of two weeks.~After another two weeks, 250mg claritromycin is replaced by 500mg claritromycin once daily for another two weeks.~After this, there is a wash-out period of one week during which no claritromycine is administered.~Addition of different doses of clarithromycin. : At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
768404|NCT01521260|B3|Baseline|Total|Total of all reporting groups
768481|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768405|NCT01521260|B2|Baseline|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
768406|NCT01521260|B1|Baseline|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
768407|NCT01521260|P2|Participant Flow|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
768408|NCT01521260|P1|Participant Flow|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
768409|NCT01521260|O2|Outcome|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
768410|NCT01521260|O1|Outcome|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
768411|NCT01521260|E2|Reported Event|Chlorhexidine Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
768412|NCT01521260|E1|Reported Event|Placebo Group|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
768413|NCT01521143|B5|Baseline|Total|Total of all reporting groups
768414|NCT01521143|B4|Baseline|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768415|NCT01521143|B3|Baseline|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768416|NCT01521143|B2|Baseline|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768417|NCT01521143|B1|Baseline|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768418|NCT01521143|P4|Participant Flow|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768419|NCT01521143|P3|Participant Flow|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768420|NCT01521143|P2|Participant Flow|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768452|NCT01521026|B1|Baseline|Cognitive Training|Cognitive training group
768423|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768424|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768425|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768426|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768427|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768428|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768429|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768430|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768431|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768482|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768432|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768433|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768434|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768435|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768436|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768437|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768438|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768439|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768440|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768441|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768442|NCT01521143|O4|Outcome|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768443|NCT01521143|O3|Outcome|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768444|NCT01521143|O2|Outcome|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768445|NCT01521143|O1|Outcome|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768446|NCT01521143|E4|Reported Event|Part B - Observational Standard of Care|Participants in this group did not receive any treatment during the study.
768447|NCT01521143|E3|Reported Event|Part B - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768448|NCT01521143|E2|Reported Event|Part A - Placebo|Participants received intradermal injections of placebo given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks.
768449|NCT01521143|E1|Reported Event|Part A - Cvac|Participants received intradermal injections of Cvac given at 4-week intervals for the first 3 doses, and then every 12 weeks for 3 additional doses, for a total of 6 doses over 44 weeks. Each injection had an approximate concentration of 60 × 10^6 viable dendritic cells/mL.
768450|NCT01521026|B3|Baseline|Total|Total of all reporting groups
768451|NCT01521026|B2|Baseline|Standard Pharmacotherapy|standard pharmacotherapy with regular clinician
768462|NCT01520987|B8|Baseline|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
768463|NCT01520987|B7|Baseline|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768464|NCT01520987|B6|Baseline|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768465|NCT01520987|B5|Baseline|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768466|NCT01520987|B4|Baseline|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
768467|NCT01520987|B3|Baseline|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768468|NCT01520987|B2|Baseline|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768469|NCT01520987|B1|Baseline|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768470|NCT01520987|P8|Participant Flow|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
768471|NCT01520987|P7|Participant Flow|Japanese 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
768472|NCT01520987|P6|Participant Flow|Japanese 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
768473|NCT01520987|P5|Participant Flow|Japanese 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
768474|NCT01520987|P4|Participant Flow|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
768475|NCT01520987|P3|Participant Flow|Caucasian 50 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
768476|NCT01520987|P2|Participant Flow|Caucasian 25 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
768477|NCT01520987|P1|Participant Flow|Caucasian 5 mg OPC|OPC, opicapone, BIA 9-1067 (once-daily).
768478|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768479|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768597|NCT01520909|B3|Baseline|Total|Total of all reporting groups
768483|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768484|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768485|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768486|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768487|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768488|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768489|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768490|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768491|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768492|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768493|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768494|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768495|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768496|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768497|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768498|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768499|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768500|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768501|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768502|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768503|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768504|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768505|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768506|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768507|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768508|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768509|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768510|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768511|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768512|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
783665|NCT01460732|O1|Outcome|All Patients|All patients analyzed
768513|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768514|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768515|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768516|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768517|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768518|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768519|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768520|NCT01520987|O6|Outcome|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768521|NCT01520987|O5|Outcome|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768522|NCT01520987|O4|Outcome|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768523|NCT01520987|O3|Outcome|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768524|NCT01520987|O2|Outcome|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768525|NCT01520987|O1|Outcome|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768526|NCT01520987|E8|Reported Event|Japanese Placebo|"Placebo, PLC~Placebo: once-daily"
768527|NCT01520987|E7|Reported Event|Japanese 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768528|NCT01520987|E6|Reported Event|Japanese 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768529|NCT01520987|E5|Reported Event|Japanese 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768530|NCT01520987|E4|Reported Event|Caucasian Placebo|"Placebo, PLC~Placebo: once-daily"
769129|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
768531|NCT01520987|E3|Reported Event|Caucasian 50 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768532|NCT01520987|E2|Reported Event|Caucasian 25 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768533|NCT01520987|E1|Reported Event|Caucasian 5 mg OPC|"OPC, opicapone, BIA 9-1067~BIA 9-1067: 5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily)."
768534|NCT01520922|B3|Baseline|Total|Total of all reporting groups
768535|NCT01520922|B2|Baseline|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768536|NCT01520922|B1|Baseline|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768537|NCT01520922|P2|Participant Flow|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768538|NCT01520922|P1|Participant Flow|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768539|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768540|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768541|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768542|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768543|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
769249|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
768544|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768545|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768546|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768547|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768548|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768668|NCT01520727|B5|Baseline|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768669|NCT01520727|B4|Baseline|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768549|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768550|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768551|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768552|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768553|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768554|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768555|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768556|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768557|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768558|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768559|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768696|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768560|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768561|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768562|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768563|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768564|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768565|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768566|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768567|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768568|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768569|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768570|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768571|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768572|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768573|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768574|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768575|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768697|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768576|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768577|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768578|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768579|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768580|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768581|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768582|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768583|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768584|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768585|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768586|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768587|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768588|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768589|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768590|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768591|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768698|NCT01520727|O9|Outcome|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
769351|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
768592|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768593|NCT01520922|O2|Outcome|Ofatumumab + Bendamustine 70 mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768594|NCT01520922|O1|Outcome|Ofatumumab + Bendamustine 90 mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768595|NCT01520922|E2|Reported Event|Ofatumumab + Bendamustine 90mg/m^2|Participants with previously untreated CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 90 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768596|NCT01520922|E1|Reported Event|Ofatumumab + Bendamustine 70mg/m^2|Participants with relapsed CLL received IV infusions of ofatumumab in combination with bendamustine IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 mg on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Bendamustine was administered at 70 mg/m^2 on Days 1 and 2 of each cycle (6 cycles).
768598|NCT01520909|B2|Baseline|Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines.
768599|NCT01520909|B1|Baseline|Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day. In Part 2, participants received eltrombopag. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768600|NCT01520909|P3|Participant Flow|Part 2 (Open-Label Period) Eltrombopag|All participants receiving placebo in Part 1 received eltrombopag in Part 2 following starting dose guidelines for Part 1. Participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants receiving eltrombopag in Part 1 continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
768601|NCT01520909|P2|Participant Flow|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day. Participants continued on the same dose of eltrombopag in Part 2 unless adjustments were warranted according to the dosing guidelines. Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
768602|NCT01520909|P1|Participant Flow|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day). Standard of care treatments were allowed during the study, and were prescribed based on the investigator's discretion.
768603|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768604|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768605|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768606|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768607|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768608|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768609|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768610|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768611|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768612|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768613|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768614|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768615|NCT01520909|O3|Outcome|Eltrombopag Cohort 3 (1-5 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768616|NCT01520909|O2|Outcome|Eltrombopag Cohort 2 (6-11 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768617|NCT01520909|O1|Outcome|Eltrombopag Cohort 1 (12-17 Years)|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows:body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD.
768618|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768619|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768699|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768700|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768620|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight &lt;27 kg received eltrombopag 37.5 mg QD, and those with a body weight &gt;=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768621|NCT01520909|O1|Outcome|Part 1 (Randomized Period) - Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768622|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768623|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768624|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768625|NCT01520909|O1|Outcome|EPart 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768626|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768627|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768628|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768629|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768630|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768631|NCT01520909|O1|Outcome|Part 1(Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768632|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
769352|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
768633|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768634|NCT01520909|O1|Outcome|Part 1 (Randmoized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768635|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768636|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768670|NCT01520727|B3|Baseline|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768637|NCT01520909|O1|Outcome|Part 1 (Randmoized Period) -Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768638|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768639|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768640|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768641|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768642|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768643|NCT01520909|O1|Outcome|Part 2 (Open-Label Period) - Eltrombopag|Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768644|NCT01520909|O2|Outcome|Part 1 (Randomized Period) -Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
769250|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
768645|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768646|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768647|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768648|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768671|NCT01520727|B2|Baseline|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768649|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768650|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768651|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768652|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768653|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768654|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768655|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768656|NCT01520909|O2|Outcome|Part 1 (Randomized Period) - Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768657|NCT01520909|O1|Outcome|Part 1 (Randomized Period)-Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received placebo 37.5 mg QD, and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768658|NCT01520909|O2|Outcome|Part 1 (Randomized Period)-Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight <27 kg received eltrombopag 37.5 mg QD, and those with a body weight >=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768659|NCT01520909|O1|Outcome|Part 1 (Randomized Period)- Placebo|In Part 1, participants aged between 6 and 17 years with a body weight <27 kilograms (kg) received placebo 37.5 milligrams (mg) once daily (QD), and those with a body weight >=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 milligrams per kilogram (mg/kg) QD; participants of East Asian ancestry received a starting dose of placebo 0.8 milligrams per kilograms per day (mg/kg/day).
768660|NCT01520909|E3|Reported Event|Part 2: Eltrombopag|In Part 2, participants continued on the same dose of eltrombopag received in Part 1 unless adjustments were warranted according to the dosing guidelines.
768661|NCT01520909|E2|Reported Event|Part 1: Placebo|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received placebo 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
768662|NCT01520909|E1|Reported Event|Part 1: Eltrombopag|In Part 1, participants aged between 6 and 17 years with a body weight less than 27 kg received eltrombopag 37.5 mg QD, and those with a body weight greater than or equal to 27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
768663|NCT01520727|B10|Baseline|Total|Total of all reporting groups
768664|NCT01520727|B9|Baseline|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
768665|NCT01520727|B8|Baseline|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768666|NCT01520727|B7|Baseline|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768667|NCT01520727|B6|Baseline|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
769565|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
768672|NCT01520727|B1|Baseline|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768673|NCT01520727|P9|Participant Flow|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
768674|NCT01520727|P8|Participant Flow|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768675|NCT01520727|P7|Participant Flow|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768676|NCT01520727|P6|Participant Flow|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768677|NCT01520727|P5|Participant Flow|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768678|NCT01520727|P4|Participant Flow|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768679|NCT01520727|P3|Participant Flow|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768680|NCT01520727|P2|Participant Flow|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768681|NCT01520727|P1|Participant Flow|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768682|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768683|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768684|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768685|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768686|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768687|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768688|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768689|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768690|NCT01520727|O8|Outcome|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768691|NCT01520727|O7|Outcome|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768692|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768693|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768694|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768695|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
769484|NCT01519089|E3|Reported Event|Total|(=sum across Arm/Groups)
768701|NCT01520727|O6|Outcome|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768702|NCT01520727|O5|Outcome|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768703|NCT01520727|O4|Outcome|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768704|NCT01520727|O3|Outcome|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768705|NCT01520727|O2|Outcome|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768706|NCT01520727|O1|Outcome|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768707|NCT01520727|E9|Reported Event|Placebo|"Placebo (PLC): single-dose~Placebo: single-dose"
768708|NCT01520727|E8|Reported Event|BIA 9-1067 1200 mg|"BIA 9-1067 (Opicapone, OPC) - 1200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768709|NCT01520727|E7|Reported Event|BIA 9-1067 800 mg|"BIA 9-1067 (Opicapone, OPC) - 800 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768710|NCT01520727|E6|Reported Event|BIA 9-1067 400 mg|"BIA 9-1067 (Opicapone, OPC) - 400 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768711|NCT01520727|E5|Reported Event|BIA 9-1067 200 mg|"BIA 9-1067 (Opicapone, OPC) - 200 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768712|NCT01520727|E4|Reported Event|BIA 9-1067 100 mg|"BIA 9-1067 (Opicapone, OPC) - 100 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768713|NCT01520727|E3|Reported Event|BIA 9-1067 50 mg|"BIA 9-1067 (Opicapone, OPC) - 50 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
769566|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
768714|NCT01520727|E2|Reported Event|BIA 9-1067 25 mg|"BIA 9-1067 (Opicapone, OPC) - 25 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768715|NCT01520727|E1|Reported Event|BIA 9-1067 10 mg|"BIA 9-1067 (Opicapone, OPC) - 10 mg~BIA 9-1067: single ascending doses in up to 8 sequential groups of 8 healthy young male subjects"
768716|NCT01520714|B3|Baseline|Total|Total of all reporting groups
768717|NCT01520714|B2|Baseline|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768718|NCT01520714|B1|Baseline|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768719|NCT01520714|P2|Participant Flow|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV Lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768720|NCT01520714|P1|Participant Flow|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768721|NCT01520714|O2|Outcome|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768722|NCT01520714|O1|Outcome|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms both had same follow-up testing and schedule.~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead: 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images were taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768723|NCT01520714|E2|Reported Event|Medtronic Passive Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768753|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
769637|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
768724|NCT01520714|E1|Reported Event|Medtronic 4195 Active Fixation LV Lead|"Medtronic 4195 Active Fixation LV lead and Medtronic passive fixation LV lead arms will both have same follow-up testing and schedule~Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead : 1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position."
768725|NCT01520532|B1|Baseline|Ablation|
768726|NCT01520532|P1|Participant Flow|Ablation|Single-arm study, all subjects received a radio-frequency (RF) ablation with the goal of achieving Pulmonary Vein Isolation (PVI).
768727|NCT01520532|O1|Outcome|Ablation|
768728|NCT01520532|O1|Outcome|Ablation|
768729|NCT01520532|O1|Outcome|Ablation|
768730|NCT01520532|E1|Reported Event|Ablation|
768731|NCT01520506|B1|Baseline|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
768732|NCT01520506|P1|Participant Flow|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. Radiofrequency (RF) is applied with pre-programmed time and intensity in each of the renal arteries.
768733|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
768734|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
768735|NCT01520506|O1|Outcome|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
768736|NCT01520506|E1|Reported Event|Rapid Renal Denervation|Covidien OneShot™ System: Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
768737|NCT01520454|B5|Baseline|Total|Total of all reporting groups
768738|NCT01520454|B4|Baseline|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768739|NCT01520454|B3|Baseline|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768740|NCT01520454|B2|Baseline|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768741|NCT01520454|B1|Baseline|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768742|NCT01520454|P4|Participant Flow|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768743|NCT01520454|P3|Participant Flow|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768744|NCT01520454|P2|Participant Flow|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768745|NCT01520454|P1|Participant Flow|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours"
768746|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768747|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768748|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768749|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768750|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768751|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768752|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768754|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768755|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768756|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768757|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768758|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768759|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768760|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768761|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768762|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
769567|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
768763|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768764|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768765|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768766|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768767|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768768|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768769|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768770|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768771|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768772|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768773|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768774|NCT01520454|O4|Outcome|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768775|NCT01520454|O3|Outcome|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768776|NCT01520454|O2|Outcome|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768777|NCT01520454|O1|Outcome|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768778|NCT01520454|E4|Reported Event|Oral Fat|"Oral fat load with IV saline~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~oral fat: Soybean oil by mouth at 1.25 g/kg x 2 doses"
768779|NCT01520454|E3|Reported Event|Low Dose Fat Solution|"Low dose IV Intralipid with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768780|NCT01520454|E2|Reported Event|High Dose Fat Solution|"Intralipid at high dose, with heparin and PO water~Intralipid: Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768781|NCT01520454|E1|Reported Event|Placebo|"IV saline with heparin, oral water~Saline: IV saline at 0.83 mL/kg/hr for six hours~Water: Water by mouth~Heparin: Heparin bolus of 1000 units followed by 800 u/hr, adjust per PTT, for 5.5 hours"
768782|NCT01520402|B1|Baseline|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
768783|NCT01520402|P1|Participant Flow|Warfarin|"Healthy subjects age 18-74 with no medical indication for warfarin therapy, who are free of medications and co-morbid medical conditions with the potential to interfere with warfarin metabolism, and who are willing to follow a fixed vitamin K diet (men 120 micrograms/day, women 90 micrograms/day) are included.~Warfarin : Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin)."
768784|NCT01520402|O1|Outcome|CYP2C9/VKORC1 Genotype Group|Group 1 (CYP2C9 wild-type and VKORC1 wild-type), Group 2 (CYP2C9 wild-type and VKORC1 variant), Group 3 (CYP2C9 variant and VKORC1 wild-type), and Group 4 (CYP2C9 variant and VKORC1 variant).
768785|NCT01520402|O4|Outcome|Demographic Plus CYP2C9 and VKORC1 and CYP4F2|
768786|NCT01520402|O3|Outcome|Demographic Plus CYP2C9 and VKORC1|
768787|NCT01520402|O2|Outcome|Demographic Plus CYP2C9|
768788|NCT01520402|O1|Outcome|Demographic Only|Demographic variables were gender, age, and race.
768789|NCT01520402|O1|Outcome|CYP4F2 (p.V433M; c.1297G>A)|"CYP4F2 G/G was defined as wild-type, CYP4F2 G/A was defined as single-variant, and CYP4F2 A/A was defined as double-variant"
768790|NCT01520402|O2|Outcome|VKORC1 -1639 G>A|"VKORC1 GG was defined as wild-type; VKORC1 G/A was defined as single variant; and VKORC1 A/A was defined as double variant."
768791|NCT01520402|O1|Outcome|CYP2C9|"The wild-type CYP2C9 allele (*1) was assigned in the absence of other detectable variant alleles. Extensive metabolizers (EMs) were defined as *1/*1 wild-type, intermediate metabolizers (IMs) as *1/variant single variant; and poor metabolizers (PMs) as variant/variant double variant."
768792|NCT01520402|E1|Reported Event|Warfarin|Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin).
768793|NCT01519960|B4|Baseline|Total|Total of all reporting groups
768794|NCT01519960|B3|Baseline|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768795|NCT01519960|B2|Baseline|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768796|NCT01519960|B1|Baseline|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768797|NCT01519960|P3|Participant Flow|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768798|NCT01519960|P2|Participant Flow|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week principal observation period (POP). For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced hepatitis B envelope antigen (HBeAg) seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768912|NCT01519921|B2|Baseline|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
769251|NCT01519427|E1|Reported Event|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
768799|NCT01519960|P1|Participant Flow|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received peginterferon alfa-2a (PEG-IFN) monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 micrograms (mcg) was based on body surface area (BSA) and given as a once-weekly subcutaneous (SC) injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 square meters (m^2), 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; greater than (>) 1.51 m^2, 180 mcg.
768800|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768801|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768802|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768923|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
769568|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
768803|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768804|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768805|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768806|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768807|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768808|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768809|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768810|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768913|NCT01519921|B1|Baseline|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
769347|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
768811|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768812|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768813|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768814|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768815|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768816|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768817|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768818|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768819|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768820|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768821|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768822|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
769348|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
768823|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768824|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768825|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768924|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768826|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768827|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768828|NCT01519960|O1|Outcome|All Groups Combined|Participants without advanced fibrosis were randomized to receive PEG-IFN monotherapy or were evaluated as untreated control for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for the same duration. For those who received PEG-IFN treatment, each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768829|NCT01519960|O3|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768830|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768831|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768832|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768833|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768834|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768917|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
769638|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
768835|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768836|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768837|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768925|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768838|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768839|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768840|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768841|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768842|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768843|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768844|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768845|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768846|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768847|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768848|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768914|NCT01519921|P2|Participant Flow|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants received PEGASYS 180mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768849|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768850|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768851|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768852|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768853|NCT01519960|O1|Outcome|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768854|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768855|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768856|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768857|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768858|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768859|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768860|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
769349|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
768861|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768862|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
769130|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
769131|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
768863|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768864|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768865|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768866|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768867|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768868|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768869|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768870|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768871|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768915|NCT01519921|P1|Participant Flow|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received peginterferon alfa-2a (PEGASYS) 180 micrograms (mcg) subcutaneously (SC) once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
783666|NCT01460732|O1|Outcome|All Patients|All patients analyzed
768872|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768873|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768874|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768875|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768876|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768877|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768878|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768879|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768880|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768881|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768882|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768883|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768884|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768885|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768886|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768887|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768888|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768889|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768890|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768891|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768892|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768893|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768916|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
783667|NCT01460732|O1|Outcome|All Patients|All patients analyzed
768894|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768895|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768896|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768897|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768898|NCT01519960|O2|Outcome|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up. After completing the POP, the same PEG-IFN regimen administered in Group A was offered to participants in Group B who had not experienced HBeAg seroconversion. The offer remained for up to 1 year following the Week 48 visit. From the time a given participant switched to PEG-IFN, he/she was no longer included in Group B.
768899|NCT01519960|O1|Outcome|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768900|NCT01519960|E4|Reported Event|Group D: Switch to PEG-IFN Monotherapy|Participants without advanced fibrosis who did not receive treatment and had not experienced HBeAg seroconversion were allowed to switch to PEG-IFN monotherapy. Treatment was given over 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg. Because participants could switch from Group B to Group D for up to 1 year following the Week 48 visit, not all participants had reached FU Week 24 at time of analysis.
768901|NCT01519960|E3|Reported Event|Group C: PEG-IFN Monotherapy With Advanced Fibrosis|Participants with advanced fibrosis were allocated (not randomized) to receive PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768902|NCT01519960|E2|Reported Event|Group B: Untreated Control Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and were evaluated for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. As the study is open-label, participants did not receive any investigational or placebo treatment during the 48-week POP. For ethical reasons, participants in Group B had a reduced visit schedule (every 12 weeks) compared to participants in Group A through the end of 24-week follow-up.
768903|NCT01519960|E1|Reported Event|Group A: PEG-IFN Monotherapy Without Advanced Fibrosis|Participants without advanced fibrosis were randomized and received PEG-IFN monotherapy for 48 weeks with a 24-week follow-up and an additional ongoing 4.5-year extended follow-up. Each dose of 45 to 180 mcg was based on BSA and given as a once-weekly SC injection for 48 weeks. BSA-based dosing was as follows: 0.51–0.53 m^2, 45 mcg; 0.54–0.74 m^2, 65 mcg; 0.75–1.08 m^2, 90 mcg; 1.09–1.51 m^2, 135 mcg; >1.51 m^2, 180 mcg.
768904|NCT01519934|B1|Baseline|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
768905|NCT01519934|P1|Participant Flow|Ulthera-treated Subjects|All enrolled subjects had received one Ulthera treatment on the face and neck at two treatment depths, 4.5mm and 3.0mm depths, prior to enrollment.
768906|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
768907|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
768908|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
768909|NCT01519934|O1|Outcome|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
768910|NCT01519934|E1|Reported Event|Ulthera-treated Subjects|All enrolled subjects will have received an Ulthera treatment prior to enrollment.
768911|NCT01519921|B3|Baseline|Total|Total of all reporting groups
768918|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768919|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768920|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768921|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768922|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768926|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768927|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768928|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768929|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768930|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768931|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768932|NCT01519921|O2|Outcome|PEG-IFN Alfa-2a (YMDD Mutant)|Eligible YMDD mutant participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up. Participants received lamivudine concomitantly for the initial 12 weeks.
768933|NCT01519921|O1|Outcome|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768934|NCT01519921|E2|Reported Event|PEG-IFN Alfa-2a (YMDD Mutant)|Group B included tyrosine-methionine-aspartate-aspartate (YMDD) mutant participants who received PEGASYS 180mcg subcutaneously once weekly for 48 weeks, followed by 24 weeks of treatment-free follow- up.
768935|NCT01519921|E1|Reported Event|PEG-IFN Alfa-2a (Treatment naïve)|Eligible treatment naïve participants received PEGASYS 180 mcg SC once weekly for 48 weeks, followed by 24 weeks of treatment-free follow-up.
768936|NCT01519882|B3|Baseline|Total|Total of all reporting groups
768937|NCT01519882|B2|Baseline|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768938|NCT01519882|B1|Baseline|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768939|NCT01519882|P2|Participant Flow|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768940|NCT01519882|P1|Participant Flow|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768941|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768942|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
769038|NCT01519765|P1|Participant Flow|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
768943|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768944|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768945|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768946|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
769047|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769132|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
768947|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768948|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768949|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768950|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768951|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768952|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768953|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768954|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768955|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768956|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768957|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768958|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768959|NCT01519882|O2|Outcome|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
769039|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
783668|NCT01460732|O1|Outcome|All Patients|All patients analyzed
768960|NCT01519882|O1|Outcome|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768961|NCT01519882|E2|Reported Event|Rotigotine|"Rotigotine Transdermal Patches~Rotigotine : Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
768962|NCT01519882|E1|Reported Event|Placebo|"Placebo Transdermal Patches~Placebo : Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
768963|NCT01519791|B3|Baseline|Total Title|
769048|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
814931|NCT01344460|O2|Outcome|Unenhanced MRA|
768964|NCT01519791|B2|Baseline|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768965|NCT01519791|B1|Baseline|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768966|NCT01519791|P2|Participant Flow|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768967|NCT01519791|P1|Participant Flow|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768968|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768969|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768970|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768971|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768972|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768973|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768974|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768975|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768976|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768977|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769049|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769133|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
768978|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768979|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768980|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768981|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768982|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768983|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768984|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768985|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768986|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768987|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768988|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768989|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769040|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769639|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
768990|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768991|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768992|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768993|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768994|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768995|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768996|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768997|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768998|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
768999|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769000|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769001|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769002|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769003|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769041|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769640|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
769004|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769005|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769006|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769007|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769008|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769009|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769010|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769011|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769012|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769013|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769014|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769015|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769016|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769017|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769042|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769641|NCT01517750|O2|Outcome|Previous ENT Surgeries + Without Humidification|
769018|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769019|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769020|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769021|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769022|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Radiographic Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769023|NCT01519791|O1|Outcome|Placebo + Methotrexate (Radiographic Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769024|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769025|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769026|NCT01519791|O2|Outcome|Certolizumab Pegol + Methotrexate (Full Analysis Set)|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769027|NCT01519791|O1|Outcome|Placebo + Methotrexate (Full Analysis Set)|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769028|NCT01519791|E2|Reported Event|Certolizumab Pegol + Methotrexate|"Certolizumab Pegol + Methotrexate (MTX)~Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.~Injections will be given subcutaneously. CZP 400 mg + MTX at Baseline, Week 2 and Week 4, followed by a maintenance dose of CZP 200 mg + MTX every 2 Weeks until Week 50.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769029|NCT01519791|E1|Reported Event|Placebo + Methotrexate|"Placebo + Methotrexate (MTX)~2 syringes Placebo at Baseline, Week 2 and Week 4 + MTX, followed by 1 syringe Placebo every 2 Weeks + MTX.~The MTX treatment is to be initiated at a dose of 10 mg per Week. The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8."
769030|NCT01519778|B1|Baseline|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
769031|NCT01519778|P1|Participant Flow|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
769032|NCT01519778|O1|Outcome|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
769033|NCT01519778|E1|Reported Event|TR-701 FA|TR701 FA: 1 tablet 200 mg once daily
769034|NCT01519765|B3|Baseline|Total|Total of all reporting groups
769035|NCT01519765|B2|Baseline|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769036|NCT01519765|B1|Baseline|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769037|NCT01519765|P2|Participant Flow|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769246|NCT01519427|P1|Participant Flow|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
769043|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769044|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769045|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769046|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769134|NCT01519700|O5|Outcome|Total|All patients
769050|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769051|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769052|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769053|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769054|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769055|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769056|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769057|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769058|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769059|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769060|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769061|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769062|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769063|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769064|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769065|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769066|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769067|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769068|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769069|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769070|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769071|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769072|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
769073|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769074|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769247|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
769075|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769076|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769077|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769078|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
769079|NCT01519765|O2|Outcome|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769080|NCT01519765|O1|Outcome|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~This same regimen was then repeated every four hours according to protocol."
769081|NCT01519765|E2|Reported Event|Vaginal Misoprostol|Participants received misoprostol 25 mcg via vaginal route and placebo pill via buccal route. This same regimen was repeated every four hours according to protocol.
769082|NCT01519765|E1|Reported Event|Buccal Misoprostol|"Participants received misoprostol 25 mcg via buccal route and placebo pill via vaginal route.~The same regimen was then repeated every four hours according to protocol."
769083|NCT01519713|B4|Baseline|Total|Total of all reporting groups
769084|NCT01519713|B3|Baseline|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769085|NCT01519713|B2|Baseline|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769086|NCT01519713|B1|Baseline|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769087|NCT01519713|P3|Participant Flow|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769088|NCT01519713|P2|Participant Flow|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769089|NCT01519713|P1|Participant Flow|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769090|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769091|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769092|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769093|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769094|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769095|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769096|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769097|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769098|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769099|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769100|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769101|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769102|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769103|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769104|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769105|NCT01519713|O3|Outcome|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769106|NCT01519713|O2|Outcome|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769107|NCT01519713|O1|Outcome|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769108|NCT01519713|E3|Reported Event|Children Menactra® Vaccine Group|Participants aged 2 to 10 years received a single dose of Menactra® vaccine
769109|NCT01519713|E2|Reported Event|Adolescents Menactra® Vaccine Group|Participants aged 11 to 17 years received a single dose of Menactra® vaccine
769110|NCT01519713|E1|Reported Event|Adults Menactra® Vaccine Group|Participants aged 18 to 55 years received a single dose of Menactra® vaccine
769111|NCT01519700|B5|Baseline|Total|Total of all reporting groups
769112|NCT01519700|B4|Baseline|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
769113|NCT01519700|B3|Baseline|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
769114|NCT01519700|B2|Baseline|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
769115|NCT01519700|B1|Baseline|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
769116|NCT01519700|P4|Participant Flow|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study, daily dose of 5 mcg/kg body weight, subcutaneously
769117|NCT01519700|P3|Participant Flow|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle, daily dose of 5 mcg/kg body weight, subcutaneously
769248|NCT01519427|O1|Outcome|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
769118|NCT01519700|P2|Participant Flow|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle, daily dose of 5 mcg/kg body weight, subcutaneously
769119|NCT01519700|P1|Participant Flow|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study daily dose of 5 mcg/kg body weight, subcutaneously
769120|NCT01519700|O5|Outcome|Total|All patients
769121|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
769122|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
769123|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
769124|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
769125|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
769126|NCT01519700|O2|Outcome|EP2006 & Neupogen + Neupogen & EP2006|All subjects randomized to receive EP2006 & Neupogen + Neupogen & EP2006.
769127|NCT01519700|O1|Outcome|EP2006 + Neupogen|All subjects randomized to receive either EP2006 or Neupogen.
769128|NCT01519700|O3|Outcome|Total|All patients in Cycle 1
814932|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
769135|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
769136|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
769137|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
769138|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
769139|NCT01519700|O5|Outcome|Total|All patients
769140|NCT01519700|O4|Outcome|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
769141|NCT01519700|O3|Outcome|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
769142|NCT01519700|O2|Outcome|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
769143|NCT01519700|O1|Outcome|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
769144|NCT01519700|O2|Outcome|Neupogen + Neupogen & EP2006|All subjects randomized to receive Neupogen in Cycle 1
769145|NCT01519700|O1|Outcome|EP2006 + EP2006 & Neupogen|All subjects randomized to receive either EP2006 in Cycle 1
769146|NCT01519700|E4|Reported Event|Neupogen|Patients remained on Neupogen (their initial treatment) throughout the study
769147|NCT01519700|E3|Reported Event|Neupogen + EP2006|Patients received alternating treatment with Neupogen or EP2006 starting with the 2nd cycle
769148|NCT01519700|E2|Reported Event|EP2006 + Neupogen|Patients received alternating treatment with EP2006 or Neupogen starting with the second cycle
769149|NCT01519700|E1|Reported Event|EP2006|Patients remained on EP2006 (their initial treatment) throughout the study
769150|NCT01519674|B4|Baseline|Total|Total of all reporting groups
769151|NCT01519674|B3|Baseline|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769152|NCT01519674|B2|Baseline|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769153|NCT01519674|B1|Baseline|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769154|NCT01519674|P3|Participant Flow|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769155|NCT01519674|P2|Participant Flow|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769156|NCT01519674|P1|Participant Flow|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769157|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769158|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769159|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769160|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769161|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769162|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769163|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769164|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769165|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769166|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769167|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769168|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769169|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769170|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769171|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769172|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769173|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769174|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769175|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769176|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769177|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769178|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769179|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769180|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769181|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769182|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769183|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769184|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769185|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769186|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769187|NCT01519674|O3|Outcome|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769188|NCT01519674|O2|Outcome|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769189|NCT01519674|O1|Outcome|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769190|NCT01519674|E3|Reported Event|OD + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected once daily, 12 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769191|NCT01519674|E2|Reported Event|BID + Sita + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) and sitagliptin (100 mg/day) treatments.
769192|NCT01519674|E1|Reported Event|BID + Met|Biphasic insulin aspart 30 (BIAsp 30) was injected twice daily, 6 U before breakfast and 6 U before dinner (evening meal), subcutaneously (under the skin) for 24 weeks. Dosing of BIAsp 30 was adjusted individually according to the titration guideline and the subject’s self-measured plasma glucose (SMPG) levels. Subjects continued on their pre-trial metformin (1000 mg/day) treatment.
769193|NCT01519661|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769194|NCT01519661|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769195|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769219|NCT01519518|B1|Baseline|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
769315|NCT01519245|P1|Participant Flow|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
769196|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769197|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769198|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769199|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769200|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769201|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy. Total number of isolates at each cycle/day: baseline = 279; cycle 1, day 29 = 252; cycle 2, day 85 = 238; cycle 3, day 141 = 210; cycle 4, day 197 = 184; cycle 5, day 253 = 178; cycle 6, day 309 = 164; and completion, day 337 = 158
769202|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769203|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769204|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769205|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769206|NCT01519661|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769642|NCT01517750|O1|Outcome|Previous ENT Surgeries + Humidification|
769207|NCT01519661|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Eligible patients were assigned to four capsules of TIP at 28mg dosage strength, inhaled b.i.d. in the morning and in the evening via the T-326 inhaler, for 28 days (on treatment), followed by 28 days of no study treatment (off treatment). Each treatment therefore consisted of 112mg tobramycin (4 capsules of 28mg each) with the total daily dose = 224mg tobramycin (112mg b.i.d.). These 56 days represented 1 cycle of therapy.
769208|NCT01519648|B3|Baseline|Total|Total of all reporting groups
769209|NCT01519648|B2|Baseline|Allo- or Auto- Transplant Recipients|
769210|NCT01519648|B1|Baseline|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
769211|NCT01519648|P2|Participant Flow|Allo- or Auto- Transplant Recipients|
769212|NCT01519648|P1|Participant Flow|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
769213|NCT01519648|O2|Outcome|Allo- or Auto- Transplant Recipients|Allo- or auto- transplant recipients
769214|NCT01519648|O1|Outcome|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
769215|NCT01519648|E2|Reported Event|Allo- or Auto- Transplant Recipients|
769216|NCT01519648|E1|Reported Event|Acute Leukemia Patients|Patients with de novo or relapsed acute myeloid and lymphoid leukemia
769217|NCT01519518|B3|Baseline|Total|Total of all reporting groups
769218|NCT01519518|B2|Baseline|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
769220|NCT01519518|P2|Participant Flow|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
769221|NCT01519518|P1|Participant Flow|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
769222|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
769223|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
769224|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
769225|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
769226|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
769227|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
769228|NCT01519518|O2|Outcome|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
769229|NCT01519518|O1|Outcome|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
769230|NCT01519518|E2|Reported Event|Bivalirudin|"intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour~Bivalirudin: intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour"
769231|NCT01519518|E1|Reported Event|Unfractionated Heparin|"70 units/kg body weight intravenous~unfractionated heparin: 70 units/kg body weight intravenous"
769232|NCT01519466|B3|Baseline|Total|Total of all reporting groups
769233|NCT01519466|B2|Baseline|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
769234|NCT01519466|B1|Baseline|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
769235|NCT01519466|P2|Participant Flow|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
769236|NCT01519466|P1|Participant Flow|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
769237|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
769238|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
769239|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
769240|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
769241|NCT01519466|O2|Outcome|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
769242|NCT01519466|O1|Outcome|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
769243|NCT01519466|E2|Reported Event|FreeStyle Freedom Lite|"Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.~FreeStyle Freedom Lite: FreeStyle Freedom Lite is a blood glucose meter"
769244|NCT01519466|E1|Reported Event|FreeStyle InsuLinx|"Subjects will use a FreeStyle InsuLinx blood glucose meter during the study~FreeStyle InsuLinx: FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature."
769245|NCT01519427|B1|Baseline|Treatment (Selumetinib and Akt Inhibitor MK2206)|Patients receive selumetinib PO BID on days 1-21 and Akt inhibitor MK2206 PO once weekly.
769252|NCT01519323|B1|Baseline|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769253|NCT01519323|P2|Participant Flow|Vemurafenib Dose Escalation Cohort Level 2|Participants received 960 mg of vemurafenib by mouth BID.
769254|NCT01519323|P1|Participant Flow|Vemurafenib Dose Escalation Cohort Level 1|Participants received 720 milligram (mg) of vemurafenib by mouth twice daily (BID).
769255|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769256|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769316|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
769257|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769258|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769259|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769260|NCT01519323|O2|Outcome|Vemurafenib 960 mg|Participants enrolled in the second cohort received vemurafenib 960 mg by mouth BID.
769261|NCT01519323|O1|Outcome|Vemurafenib 720 mg|Participants enrolled in the first cohort received vemurafenib 720 mg by mouth BID.
769262|NCT01519323|O1|Outcome|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769263|NCT01519323|E1|Reported Event|Vemurafenib|Participants received vemurafenib into two separate cohorts with different starting doses based on greater than or equal to (>=)45 kilogram (kg) and other weighing less than (<)45 kg. The starting dose for participants (>=45 kg) was 720 milligram (mg) of vemurafenib by mouth twice daily (BID) and the next dose level for participants in this cohort was 960 mg by mouth BID. The starting dose level for participants weighing <45 kg was to be 480 mg of vemurafenib by mouth BID, but no participants were enrolled into this cohort.
769264|NCT01519284|B6|Baseline|Total|Total of all reporting groups
769265|NCT01519284|B5|Baseline|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose~Entacapone: Entacapone 200 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
769266|NCT01519284|B4|Baseline|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 30 mg: BIA 9-1067 OPC, Opicapone 30 mg"
769267|NCT01519284|B3|Baseline|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)~BIA 9-1067 15 mg: BIA 9-1067 OPC, Opicapone 15 mg"
769268|NCT01519284|B2|Baseline|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose~BIA 9-1067 5 mg: BIA 9-1067 OPC, Opicapone 5 mg~Placebo: placebo (four times a day)~levodopa/carbidopa: standard release levodopa/carbidopa 100/25 mg (single-dose)"
769269|NCT01519284|B1|Baseline|Group 1|"Placebo at all the dosing times~Placebo: placebo (four times a day)"
769270|NCT01519284|P5|Participant Flow|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
769271|NCT01519284|P4|Participant Flow|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
769272|NCT01519284|P3|Participant Flow|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769680|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769273|NCT01519284|P2|Participant Flow|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769274|NCT01519284|P1|Participant Flow|Group 1|Placebo at all the dosing times
769275|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
769276|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
769277|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769278|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769279|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
769280|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
769281|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
769282|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769313|NCT01519245|B1|Baseline|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
769283|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769284|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
769285|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
769286|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
769287|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769288|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769289|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
769290|NCT01519284|O5|Outcome|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
769291|NCT01519284|O4|Outcome|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
769292|NCT01519284|O3|Outcome|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769293|NCT01519284|O2|Outcome|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769294|NCT01519284|O1|Outcome|Group 1|Placebo at all the dosing times
769295|NCT01519284|E5|Reported Event|Group 5|"Day 1 to 7:~Placebo: 7 AM dose; Entacapone 200 mg: 8 AM; 4 PM; 12 PM dose~Day 8:~Placebo: 7 AM dose Entacapone 200 mg + levodopa/carbidopa 100/25 mg: 8 AM dose"
769296|NCT01519284|E4|Reported Event|Group 4|"Day 1 to 7:~BIA 9-1067 30 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 30 mg: 7 AM dose Placebo + levodopa/carbidopa 100/25 mg: 8 AM dose"
769297|NCT01519284|E3|Reported Event|Group 3|"Day 1 to 7:~BIA 9-1067 15 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 15 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769298|NCT01519284|E2|Reported Event|Group 2|"Day 1 to 7:~BIA 9-1067 5 mg: 7 AM dose Placebo: 8 AM; 4 PM; 12 PM dose~Day 8:~BIA 9-1067 5 mg: 7 AM dose Placebo+ levodopa/carbidopa 100/25 mg: 8 AM dose"
769299|NCT01519284|E1|Reported Event|Group 1|Placebo at all the dosing times
769300|NCT01519271|B3|Baseline|Total|Total of all reporting groups
769301|NCT01519271|B2|Baseline|5-10cm2 Rivastigmine Patch First First Then Placebo Patch|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).~Each phase lasted 10 weeks."
769302|NCT01519271|B1|Baseline|Placebo Patch First Then 5-10cm2 Rivastigmine Patch|"Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Each phase lasted 10 weeks."
769303|NCT01519271|P2|Participant Flow|Rivastigmine First Then Placebo|"5-10cm2 rivastigmine patch daily first in phase 1 and placebo patch daily in phase 2. Each phase lasted for 10 weeks.~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
769304|NCT01519271|P1|Participant Flow|Placebo First Then Rivastigmine|"Placebo patches placed on skin daily in Phase 1 and Rivastigmine 5-10cm2 patches in Phase 2. Each phase lasted for 10 weeks.~Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )~Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine)."
769350|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
783669|NCT01460732|O1|Outcome|All Patients|All patients analyzed
769305|NCT01519271|O2|Outcome|Rivastigmine|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
769306|NCT01519271|O1|Outcome|Placebo|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
769307|NCT01519271|O2|Outcome|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
769308|NCT01519271|O1|Outcome|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
769309|NCT01519271|E2|Reported Event|Exelon Patch (Rivastigmine Transdermal System)|"Exelon Patch (rivastigmine transdermal system): The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
769310|NCT01519271|E1|Reported Event|Placebo Patch|Placebo Patches: The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
769311|NCT01519245|B3|Baseline|Total|Total of all reporting groups
769312|NCT01519245|B2|Baseline|Placebo|Normal saline (70mL)
769314|NCT01519245|P2|Participant Flow|Placebo|Normal saline (70mL)
769317|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
769318|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
769319|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
769320|NCT01519245|O2|Outcome|Placebo|Normal saline (70mL)
769321|NCT01519245|O1|Outcome|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
769322|NCT01519245|O2|Outcome|Placebo|"Normal saline (70mL)~Total duration that chest tubes were in-situ before removal = 21 hours (SD 2)"
769323|NCT01519245|O1|Outcome|Trial Drug|"Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)~Total duration that chest tubes were in-situ before removal = 20 hours (SD 3)"
769324|NCT01519245|E2|Reported Event|Placebo|Normal saline (70mL)
769325|NCT01519245|E1|Reported Event|Trial Drug|Total 70mL solution containing 2 grams tranexamic acid (20mL) + normal saline (50mL)
769326|NCT01519206|B1|Baseline|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769327|NCT01519206|P1|Participant Flow|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769328|NCT01519206|O3|Outcome|Treated Subjects PSQ Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769329|NCT01519206|O2|Outcome|Treated Subjects PSQ Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769330|NCT01519206|O1|Outcome|Treated Subjects PSQ Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769331|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769332|NCT01519206|O4|Outcome|Treated Subjects GAIS Data - 1 Year Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769333|NCT01519206|O3|Outcome|Treated Subjects GAIS Data - 180 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769334|NCT01519206|O2|Outcome|Treated Subjects GAIS Data - 90 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769335|NCT01519206|O1|Outcome|Treated Subjects GAIS Data - 60 Days Post-treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769336|NCT01519206|O1|Outcome|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769337|NCT01519206|E1|Reported Event|Ultherapy Treatment|Study subjects received a full face Ultherapy treatment delivering approximately 500 treatment lines at two treatment depths, i.e., 4.5mm and 3.0mm depth.
769338|NCT01519167|B3|Baseline|Total|Total of all reporting groups
769339|NCT01519167|B2|Baseline|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769340|NCT01519167|B1|Baseline|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769341|NCT01519167|P2|Participant Flow|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769342|NCT01519167|P1|Participant Flow|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769343|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769344|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769345|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769346|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769353|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769354|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769355|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769356|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769357|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769358|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769359|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769360|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769361|NCT01519167|O2|Outcome|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769362|NCT01519167|O1|Outcome|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769363|NCT01519167|E2|Reported Event|Dose Level 2|Dexmedetomidine Loading dose 1 mcg/kg and Maintenance dose 0.6 mcg/kg/hr
769364|NCT01519167|E1|Reported Event|Dose Level 1|Dexmedetomidine Loading dose 0.1 mcg/kg and Maintenance dose 0.1 mcg/kg/hr
769365|NCT01519089|B3|Baseline|Total|Total of all reporting groups
769366|NCT01519089|B2|Baseline|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769367|NCT01519089|B1|Baseline|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769494|NCT01518946|O1|Outcome|Placebo|single dose of matching placebo
769368|NCT01519089|P2|Participant Flow|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769369|NCT01519089|P1|Participant Flow|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769370|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769371|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769372|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769373|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769374|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769375|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769376|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769377|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769378|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769379|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769380|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769381|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769382|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769383|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769384|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769385|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769386|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769387|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769388|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769389|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769390|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769391|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769392|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769393|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769394|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769395|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769396|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769397|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769727|NCT01516437|E2|Reported Event|HS Group|Healthy smokers aged between 45-75 years
769398|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769399|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769400|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769401|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769402|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769403|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769404|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769405|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769406|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769407|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769408|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769409|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769563|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
769410|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769411|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769412|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769413|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769414|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769415|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769416|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769417|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769418|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769419|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769420|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769421|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769422|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769423|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769424|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769425|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769426|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769427|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769428|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769429|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769430|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769431|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769432|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769433|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769434|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769435|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769436|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769437|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769438|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769439|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769440|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769441|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769442|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769443|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769444|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769445|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769446|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769447|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769448|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769449|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769450|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769451|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769452|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769453|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769454|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769455|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769456|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769457|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769458|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769459|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769460|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769461|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769462|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769463|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769464|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769465|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769466|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769467|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769468|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769469|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769470|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769471|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769472|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769473|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769474|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769475|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769476|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769477|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769478|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769479|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769480|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769481|NCT01519089|O3|Outcome|Total|(=sum across Arm/Groups)
769482|NCT01519089|O2|Outcome|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769483|NCT01519089|O1|Outcome|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769485|NCT01519089|E2|Reported Event|CP-690,550 10 mg BID|CP-690,550 10 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769486|NCT01519089|E1|Reported Event|CP-690,550 5 mg BID|CP-690,550 5 mg tablet orally twice daily (BID) up to Week 16: CP-690,550 10 mg BID from Week 16 to 20: variable 5 or 10 mg BID from Week 20 to Week 52.
769487|NCT01518946|B3|Baseline|Total|Total of all reporting groups
769488|NCT01518946|B2|Baseline|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
769489|NCT01518946|B1|Baseline|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
769490|NCT01518946|P3|Participant Flow|Midodrine HCl First, Then Placebo (Randomized Phase)|Midodrine hydrochloride dose at the subject's current dose level for the first intervention Day 2, then placebo for second intervention on Day 3.
769491|NCT01518946|P2|Participant Flow|Placebo First, Then Midodrine HCl (Randomized Phase)|Placebo for first intervention on Day 2, then Midodrine hydrochloride dose at the subject's current dose level for the second intervention on Day 3.
769492|NCT01518946|P1|Participant Flow|Midodrine HCl (Open-label Phase)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld.
769493|NCT01518946|O2|Outcome|Midodrine HCl|dose at the subject's current dose level
769495|NCT01518946|E3|Reported Event|Midodrine HCl (Randomized Phase)|dose at the subject's current dose level
769496|NCT01518946|E2|Reported Event|Placebo (Randomized Phase)|single dose of matching placebo
769497|NCT01518946|E1|Reported Event|Midodrine HCl (Open-label Phase)|dose at the subject's current dose level
769498|NCT01518530|B1|Baseline|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
769499|NCT01518530|P1|Participant Flow|Chronic Neck Pain Patients Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
769500|NCT01518530|O1|Outcome|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
769501|NCT01518530|E1|Reported Event|Patients With Chronic Neck Pain Treated With Occiflex|Occiflex is a computerized robotic system for the accurate 3-dimensional mobilization of the head and neck.
769502|NCT01518322|B1|Baseline|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
769503|NCT01518322|P1|Participant Flow|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
769504|NCT01518322|O1|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
769505|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
769506|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
769507|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
769508|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high
769509|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
769510|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
769511|NCT01518322|O3|Outcome|High FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and High FeNO per the American Thoracic Society (ATS) standards. For those aged 12 years or older, >50 ppb is high. For children under age 12 years, >35 ppb is high.
769512|NCT01518322|O2|Outcome|Intermediate FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and intermediate FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, ≥20 ppb and ≤35 ppb is intermediate. For those aged 12 years or older, ≥25 ppb and ≤50 ppb.
769513|NCT01518322|O1|Outcome|Low FeNO|Subjects with their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements and Low FeNO per the American Thoracic Society (ATS) standards. For children under age 12 years, <20 ppb is low. For those aged 12 years or older, <25 ppb is low.
769728|NCT01516437|E1|Reported Event|HNS Group|Healthy non-smokers aged between 45-75 years
769514|NCT01518322|E1|Reported Event|FeNO|All subjects will have their Fractional Exhaled Nitric Oxide (FeNO) measured with the NIOX MINO® device according to instructions for NO measurements.
769515|NCT01518270|B1|Baseline|Healthy Females|Participant's eyelashes were photographed at one study visit.
769516|NCT01518270|P1|Participant Flow|Healthy Females|Participant's eyelashes were photographed at one study visit.
769517|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
769518|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
769519|NCT01518270|O1|Outcome|Healthy Females|Participant's eyelashes were photographed at one study visit.
769520|NCT01518270|E1|Reported Event|Healthy Females|Healthy Females
769521|NCT01518257|B3|Baseline|Total|Total of all reporting groups
769522|NCT01518257|B2|Baseline|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769523|NCT01518257|B1|Baseline|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769524|NCT01518257|P2|Participant Flow|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769525|NCT01518257|P1|Participant Flow|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769526|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769527|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769528|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769529|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769530|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769531|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769532|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769533|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769534|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769535|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769536|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769537|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769538|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769539|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769540|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769541|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769542|NCT01518257|O2|Outcome|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769543|NCT01518257|O1|Outcome|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769544|NCT01518257|E2|Reported Event|Placebo|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
769545|NCT01518257|E1|Reported Event|Botulinum Toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
769546|NCT01518244|B1|Baseline|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
769547|NCT01518244|P1|Participant Flow|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
769548|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
769549|NCT01518244|O1|Outcome|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
769550|NCT01518244|E1|Reported Event|AZARGA®|Brinzolamide/timolol maleate fixed combination, 1 drop self-administered in study eye(s) twice a day for 8 weeks
769551|NCT01518192|B4|Baseline|Total|Total of all reporting groups
769552|NCT01518192|B3|Baseline|Controls|To obtain a control group from the same geographical area, each patient was asked if he/she had a family member or friend who was within 5 years of his/her age and had no history of Lyme disease (two of the potential control subjects were excluded due to this reason), and was not pregnant, lactating or immunocompromised.
769553|NCT01518192|B2|Baseline|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
769643|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769729|NCT01516268|B3|Baseline|Total|Total of all reporting groups
783670|NCT01460732|O1|Outcome|All Patients|All patients analyzed
769554|NCT01518192|B1|Baseline|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with either doxycycline 100 mg or cefuroxime axetil 500 mg twice daily, by alternating treatment regimens each week.~Evaluations:~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured as previously described; this procedure was repeated 2-3 months later in patients with a positive culture."
769555|NCT01518192|P3|Participant Flow|Controls|patients' family members or friends without a history of Lyme disease
769556|NCT01518192|P2|Participant Flow|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
769557|NCT01518192|P1|Participant Flow|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
769558|NCT01518192|O2|Outcome|Controls|controls with selected subjective symptoms at 12 months post inclusion
769559|NCT01518192|O1|Outcome|Patients|patients with selected subjective symptoms at 12 months post inclusion
769560|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since erythema migrans at 12 months post inclusion
769561|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 12 months post inclusion
769562|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
814933|NCT01344460|O2|Outcome|Unenhanced MRA|
769569|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
769570|NCT01518192|O2|Outcome|Controls|controls with new or increased symptoms since enrollment at 6 months post inclusion
769571|NCT01518192|O1|Outcome|Patients|patients with new or increased symptoms since erythema migrans at 6 months post inclusion
769572|NCT01518192|O2|Outcome|Cefuroxime Axetil|cefuroxime axetil 500 mg twice daily for 15 days
769573|NCT01518192|O1|Outcome|Doxycycline|doxycycline 100 mg twice daily for 15 days
769574|NCT01518192|E3|Reported Event|Controls|patients' family members or friends without a history of Lyme disease
769575|NCT01518192|E2|Reported Event|Cefuroxime Axetil|"Patients were assigned to receive a 15-day oral treatment with cefuroxime axetil 500 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
769576|NCT01518192|E1|Reported Event|Doxycycline|"Patients were assigned to receive a 15-day oral treatment with doxycycline 100 mg twice daily.~At baseline and at 14 days, 2, 6, and 12 months thereafter, patients were interviewed and examined. At baseline, a skin biopsy specimen was cultured; this procedure was repeated 2-3 months later in patients with a positive culture."
769577|NCT01518153|B1|Baseline|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769578|NCT01518153|P3|Participant Flow|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769579|NCT01518153|P2|Participant Flow|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769580|NCT01518153|P1|Participant Flow|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
769602|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769581|NCT01518153|O1|Outcome|Stem Cell Transplant + Donor Lymphocyte Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1 x 10^6 CD3+ cells/kg or 3 x 10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769582|NCT01518153|O2|Outcome|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769583|NCT01518153|O1|Outcome|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769650|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769696|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769584|NCT01518153|E3|Reported Event|High Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 3*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769585|NCT01518153|E2|Reported Event|Low Dose Donor T-Cells|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused. Planned Donor Lymphocyte Infusion CD3+ cells: 1*10^6 CD3+ cells/kg between Day +56 & +64. Tacrolimus 0.015 mg/kg IV as continuous infusion daily to achieve therapeutic level of 5-15 ng/ml (target 10 ng/ml). Tacrolimus changed to oral dosing, tapering approximately Day +35 to off by Day +42. Methotrexate 5 mg/m^2 administered IV days +1, +3, +6. G-CSF 5 mcg/kg/day subcutaneously beginning Day +7, continuing until absolute neutrophil count (ANC)> 500*10/L for 3 consecutive days.
769586|NCT01518153|E1|Reported Event|Stem Cell Infusion|Fludarabine 40 mg/m^2 intravenous (IV) administered from Day -6 to -3, Melphalan 140 mg/m^2 IV on Day -2 and Alemtuzumab 50 mg IV on Day -1. Day 0 Stem Cell infusion: Fresh or cryopreserved peripheral blood progenitor cells infused.
769587|NCT01517984|B4|Baseline|Total|Total of all reporting groups
769588|NCT01517984|B3|Baseline|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769589|NCT01517984|B2|Baseline|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769590|NCT01517984|B1|Baseline|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
769591|NCT01517984|P4|Participant Flow|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769633|NCT01517750|P2|Participant Flow|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
783671|NCT01460732|O1|Outcome|All Patients|All patients analyzed
769592|NCT01517984|P3|Participant Flow|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769593|NCT01517984|P2|Participant Flow|Transplanted, Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
769594|NCT01517984|P1|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did receive a living-donor kidney allograft transplant as specified by the protocol.
769651|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769652|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769595|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769596|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769597|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769598|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769599|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769600|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769601|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769679|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
783672|NCT01460732|E1|Reported Event|All Patients|All patients analyzed
769603|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769604|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769694|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
814934|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
769605|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769606|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769607|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769608|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769609|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769610|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769611|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769634|NCT01517750|P1|Participant Flow|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints classified as a NPC score equal or less than 9) of nasopharyngeal problems.
769612|NCT01517984|O2|Outcome|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where the continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769613|NCT01517984|O1|Outcome|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769614|NCT01517984|E3|Reported Event|Randomized to Control Group|Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to control group, where they continued on the pre-randomization standard care of mycophenolate mofetil, prednisone, and tacrolimus. Participants were followed up to 18 months after being randomized.
769615|NCT01517984|E2|Reported Event|Randomized to Tacrolimus Withdrawal|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for 6-8 months then randomized to tacrolimus withdrawal. Following randomization these participants had their dose of tacrolimus withdrawn gradually over three to four months, with complete withdrawal occurring no later than four months. Participants were followed up to 18 months after being randomized.
769616|NCT01517984|E1|Reported Event|Transplanted, But Not Randomized|These participants were enrolled into the study and received a living-donor kidney allograft transplant. Participants were given an induction therapy with rabbit antithymocyte globulin (1.5-2.0 mg/kg daily for 5 days) and treated with a regimen of mycophenolate mofetil (target dose of 1000 mg twice daily), prednisone (no less than 5 mg/day or 10 mg every other day) and tacrolimus (0.1 mg/kg twice daily, adjusted to target trough levels of 8-12 ng/ml in first 3 months post-transplant, 5-8 ng/ml thereafter). Participants were followed for up to 8 months and deemed ineligible for randomization or terminated for other reasons.
769617|NCT01517893|B3|Baseline|Total|Total of all reporting groups
769618|NCT01517893|B2|Baseline|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
769619|NCT01517893|B1|Baseline|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
769620|NCT01517893|P2|Participant Flow|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
769621|NCT01517893|P1|Participant Flow|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
769622|NCT01517893|O2|Outcome|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
769623|NCT01517893|O1|Outcome|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
769624|NCT01517893|E2|Reported Event|Placebo Arm|Placebo: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
769625|NCT01517893|E1|Reported Event|Intervention Arm|"Sig: Simvastatin 40 mg, increased to 80 mg after 1 month if initial dose tolerated~Simvastatin: Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated"
769626|NCT01517750|B5|Baseline|Total|Total of all reporting groups
769627|NCT01517750|B4|Baseline|APAP Without Humidification + High Risks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769628|NCT01517750|B3|Baseline|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769629|NCT01517750|B2|Baseline|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769630|NCT01517750|B1|Baseline|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769631|NCT01517750|P4|Participant Flow|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) without Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
769632|NCT01517750|P3|Participant Flow|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ (continuous positive airway pressure) with Thermosmart heated tube with patients who are classified to have a high risks (major complaints classified as a NPC score more than 9) of nasopharyngeal problems.
769635|NCT01517750|O4|Outcome|WIthout Previous ENT Surgeries + WIthout Humidification|
769636|NCT01517750|O3|Outcome|Without Previous ENT Surgeries + Humidification|
769644|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769645|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769646|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769647|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769648|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769649|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769695|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769653|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769654|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769655|NCT01517750|O4|Outcome|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769656|NCT01517750|O3|Outcome|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769657|NCT01517750|O2|Outcome|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769658|NCT01517750|O1|Outcome|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769659|NCT01517750|E4|Reported Event|APAP Without Humidification + High RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769660|NCT01517750|E3|Reported Event|APAP With Humidification + High Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a high risks (major complaints) of nasopharyngeal problems.
769661|NCT01517750|E2|Reported Event|APAP Without Humidification + Low RIsks of NPC|ICON Auto CPAP™ without Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769662|NCT01517750|E1|Reported Event|APAP With Humidification + Low Risks of NPC|ICON Auto CPAP™ with Thermosmart heated tube with patients who are classified to have a low risks (minor complaints) of nasopharyngeal problems.
769663|NCT01517529|B1|Baseline|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
769664|NCT01517529|P1|Participant Flow|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who failed the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
769665|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
769666|NCT01517529|O1|Outcome|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
769667|NCT01517529|E1|Reported Event|10 Hepatitis C Infected Subjects|10 chronically HCV-infected patients who fail the standard peg-IFN and Ribavirin therapy (NR) and are therefore eligible for combined treatment with Protease Inhibitor therapy.
769668|NCT01516437|B5|Baseline|Total|Total of all reporting groups
769669|NCT01516437|B4|Baseline|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769670|NCT01516437|B3|Baseline|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769671|NCT01516437|B2|Baseline|HS Group|Healthy smokers aged between 45-75 years
769672|NCT01516437|B1|Baseline|HNS Group|Healthy non-smokers aged between 45-75 years
769673|NCT01516437|P4|Participant Flow|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769674|NCT01516437|P3|Participant Flow|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769675|NCT01516437|P2|Participant Flow|HS Group|Healthy smokers aged between 45-75 years
769676|NCT01516437|P1|Participant Flow|HNS Group|Healthy non-smokers aged between 45-75 years
769677|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769678|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769681|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769682|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769683|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
769684|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769685|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769686|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769687|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769688|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769689|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
769690|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769691|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769692|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769693|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
814935|NCT01344460|O2|Outcome|Unenhanced MRA|
769697|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769698|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769699|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
769700|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769701|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769702|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769703|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769704|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769705|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
769706|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769707|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769708|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769709|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769710|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769711|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
769712|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769713|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769714|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769715|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769716|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769717|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
769718|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769719|NCT01516437|O2|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769720|NCT01516437|O1|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769721|NCT01516437|O4|Outcome|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769722|NCT01516437|O3|Outcome|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769723|NCT01516437|O2|Outcome|HS Group|Healthy smokers aged between 45-75 years
769724|NCT01516437|O1|Outcome|HNS Group|Healthy non-smokers aged between 45-75 years
769725|NCT01516437|E4|Reported Event|NFeCOPD Group|COPD patients with one exacerbation within 365 days prior to the screening visit (non-frequent exacerbators), aged between 45-75 years
769726|NCT01516437|E3|Reported Event|FeCOPD Group|COPD subjects with ≥ two exacerbations within 365 days prior to the screening visit (frequent exacerbators), aged between 45-75 years
769730|NCT01516268|B2|Baseline|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
769731|NCT01516268|B1|Baseline|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
769732|NCT01516268|P2|Participant Flow|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
769733|NCT01516268|P1|Participant Flow|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
769734|NCT01516268|O2|Outcome|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
769735|NCT01516268|O1|Outcome|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
769736|NCT01516268|E2|Reported Event|Control Group|In control group we add 1cc salin to 20cc bupivacain in TAP block
769737|NCT01516268|E1|Reported Event|Sufentanyl Group|IN case group we add 1cc sufentanyl to 20 cc bupivacain in TAP block
769738|NCT01517412|B3|Baseline|Total|Total of all reporting groups
769739|NCT01517412|B2|Baseline|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769740|NCT01517412|B1|Baseline|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769741|NCT01517412|P2|Participant Flow|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769742|NCT01517412|P1|Participant Flow|Lixisenatide Main Meal|Lixisenatide 10 mcg subcutaneous (SC) injection once daily (QD) within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769743|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769877|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769744|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769745|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769746|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769747|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769748|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769749|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769750|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769751|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769752|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769753|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769754|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769755|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769756|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769757|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769758|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769759|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769760|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769761|NCT01517412|O2|Outcome|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769762|NCT01517412|O1|Outcome|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769763|NCT01517412|E2|Reported Event|Lixisenatide Breakfast|Lixisenatide 10 mcg SC injection QD within 1 hour before “breakfast” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769764|NCT01517412|E1|Reported Event|Lixisenatide Main Meal|Lixisenatide 10 mcg SC injection QD within 1 hour before “main meal of the day” for 2 weeks, then at a maintenance dose of 20 mcg QD up to Week 24 on top of metformin.
769765|NCT01517373|B6|Baseline|Total|Total of all reporting groups
769860|NCT01517282|B1|Baseline|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769766|NCT01517373|B5|Baseline|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769767|NCT01517373|B4|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769768|NCT01517373|B3|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769769|NCT01517373|B2|Baseline|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769770|NCT01517373|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769771|NCT01517373|P6|Participant Flow|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769772|NCT01517373|P5|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769773|NCT01517373|P4|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769774|NCT01517373|P3|Participant Flow|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769878|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769775|NCT01517373|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769776|NCT01517373|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
769777|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769778|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769779|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769780|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769781|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769782|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769783|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769784|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769785|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769786|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769787|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769788|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769789|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769790|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769791|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769792|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769793|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769794|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769795|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769861|NCT01517282|P4|Participant Flow|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
786872|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
769796|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769797|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769798|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769799|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769800|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769801|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769802|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769803|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769804|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769805|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769806|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769807|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769808|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769809|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769810|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769811|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769812|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769813|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769814|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769815|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769816|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769817|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769818|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769819|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769820|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769821|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769822|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769823|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769824|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769825|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769826|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769827|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769828|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769829|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769830|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769831|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769832|NCT01517373|O5|Outcome|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769833|NCT01517373|O4|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769834|NCT01517373|O3|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769835|NCT01517373|O2|Outcome|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769836|NCT01517373|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769837|NCT01517373|E6|Reported Event|Glimepiride|Glimepiride capsule at a starting dose of 2 milligram per day (mg/day) up to a maximum dose of 6 mg/day along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769838|NCT01517373|E5|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769839|NCT01517373|E4|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769840|NCT01517373|E3|Reported Event|PF-04937319 10 mg|PF-04937319 10 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769841|NCT01517373|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet and placebo matched to glimepiride oral capsule once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
769842|NCT01517373|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
769843|NCT01517295|B3|Baseline|Total|Total of all reporting groups
769844|NCT01517295|B2|Baseline|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769845|NCT01517295|B1|Baseline|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769846|NCT01517295|P2|Participant Flow|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769847|NCT01517295|P1|Participant Flow|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769848|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769849|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769850|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769851|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769852|NCT01517295|O2|Outcome|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769853|NCT01517295|O1|Outcome|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769854|NCT01517295|E2|Reported Event|Group 2|"Blood will be drawn at 0, 2, 4, and 6 hours after one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 4.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769855|NCT01517295|E1|Reported Event|Group 1|"Blood will be drawn at 0, 1, 3, and 5 hours after taking one dose of hydrocodone/APAP. Urine will be taken at hour 0 and 3.~Hydrocodone: Dose: Standard prescribed dose Frequency: Once Duration: Once"
769856|NCT01517282|B5|Baseline|Total|Total of all reporting groups
769857|NCT01517282|B4|Baseline|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
769858|NCT01517282|B3|Baseline|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769859|NCT01517282|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769862|NCT01517282|P3|Participant Flow|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769863|NCT01517282|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769864|NCT01517282|P1|Participant Flow|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769865|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
769866|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769867|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769868|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769869|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
769870|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769871|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769872|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769873|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769874|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769875|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769876|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769879|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769880|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769881|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769882|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769883|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769884|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769885|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
769886|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769887|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769888|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769889|NCT01517282|O4|Outcome|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
769890|NCT01517282|O3|Outcome|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769891|NCT01517282|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769892|NCT01517282|O1|Outcome|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769893|NCT01517282|E4|Reported Event|Pooled Placebo|Placebo administered intravenously once every 2 weeks for a total of 6 doses
769894|NCT01517282|E3|Reported Event|MOR103 2.0 mg/kg|MOR103 2.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769895|NCT01517282|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769896|NCT01517282|E1|Reported Event|MOR103 0.5 mg/kg|MOR103 0.5 mg/kg administered intravenously every 2 weeks for a total of 6 doses.
769897|NCT01517178|B1|Baseline|Intention-to-treat Analysis Set|
769898|NCT01517178|P2|Participant Flow|New Ostomy Base Plate - Standard Care|Subjects first test New ostomy base plate then Standard Care.
769899|NCT01517178|P1|Participant Flow|Standard Care - New Ostomy Base Plate|Subjects first test Standard Care then New ostomy base plate.
769900|NCT01517178|O2|Outcome|New Ostomy Base Plate|
769901|NCT01517178|O1|Outcome|Standard Care Base Plate|
769902|NCT01517178|E2|Reported Event|New Ostomy Base Plate|Safety population includes subjects allocated to run-in period and test period.
769903|NCT01517178|E1|Reported Event|Standard Care Base Plate|Safety population includes subjects allocated to test period (no run-in period)
769904|NCT01517074|B1|Baseline|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
769905|NCT01517074|P1|Participant Flow|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
769906|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
769907|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
769908|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
770033|NCT01516008|E1|Reported Event|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
769909|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
769910|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
769911|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
769912|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
769913|NCT01517074|O1|Outcome|Sirolimus|"Participants will receive a 15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If > two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg).~Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period)."
769914|NCT01517074|E1|Reported Event|Sirolimus|Participants will receive a15 μL (660 μg) subconjunctival injection of sirolimus in the study eye at baseline if a single quadrant or two adjacent quadrants are involved. If greater than two quadrants are involved (i.e., 3 or 4 quadrant involvement) or two non-adjacent quadrants are involved, two 15 μL (660 μg) injections will be given in two quadrants 180 degrees apart (total dose of 30 μL or 1,320 μg). Participants that still demonstrate active inflammation (incomplete or no response to initial injection) or experience a flare-up (as defined by a ≥1-step increase in scleral inflammation) after the initial injection will be eligible for a re-injection in the study eye at or after Week 4 (not to exceed a dose of 1,320 μg per eye within an eight-week period).
769915|NCT01516970|B3|Baseline|Total|Total of all reporting groups
769963|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769964|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769916|NCT01516970|B2|Baseline|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
769917|NCT01516970|B1|Baseline|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769918|NCT01516970|P2|Participant Flow|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
769919|NCT01516970|P1|Participant Flow|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
770034|NCT01515943|B4|Baseline|Total|Total of all reporting groups
769920|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769921|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769922|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769923|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769924|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769925|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769926|NCT01516970|O2|Outcome|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769927|NCT01516970|O1|Outcome|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769965|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769966|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769967|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769928|NCT01516970|E2|Reported Event|Standard of Care Postexposure Prophylaxis (SOCPEP)|Standard of care human immunodeficiency virus (HIV) PEP (as per German-Austrian Guidelines): Administration of the standard of care HIV PEP (postexposure prophylaxis) consisting of 2 NRTIs plus third partner. Lopinavir in combination with low-dose ritonavir (LPV/r) [Kaletra] was combined with following NRTIs: TDF (tenofovir)/ FTC (emtricitabine) [Truvada], AZT (zidovudine)/3TC (lamivudine) [Combivir]) and ABC (Abacavir)/ 3TC (Lamivudine) administered as per the individual SmPCs at the discretion of either the treating physician or Investigator.
769929|NCT01516970|E1|Reported Event|Darunavir/Ritonavir Postexposure Prophylaxis (DRV/r PEP)|Darunavir (800 milligram [mg]) in combination with low-dose ritonavir (100 mg) administered once a day for at least 28 days and a maximum of 30 days along with 2 nucleoside/nucleotide analogue reverse transcriptase inhibitors (NRTIs). The NRTIs (including tenofovir/emtricitabine [Truvada] was administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
769930|NCT01516892|B1|Baseline|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
769931|NCT01516892|P1|Participant Flow|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
769932|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
769933|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
770032|NCT01516008|E2|Reported Event|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
769934|NCT01516892|O1|Outcome|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
769935|NCT01516892|E1|Reported Event|BOTOX®|Participants received 155 U of onabotulinumtoxinA (BOTOX®) approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
769936|NCT01516879|B3|Baseline|Total|Total of all reporting groups
769937|NCT01516879|B2|Baseline|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769938|NCT01516879|B1|Baseline|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769939|NCT01516879|P2|Participant Flow|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769940|NCT01516879|P1|Participant Flow|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769941|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769942|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769943|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769944|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769945|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769946|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769947|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769948|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769949|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769950|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769951|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769952|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769953|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769954|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769955|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769956|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769957|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769958|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769959|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769960|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769961|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769962|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
791988|NCT01433263|B2|Baseline|Placebo / Late 30mg/kg BYM338|
769968|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769969|NCT01516879|O2|Outcome|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769970|NCT01516879|O1|Outcome|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769971|NCT01516879|E2|Reported Event|Evolocumab|Participants received evolocumab 420 mg subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769972|NCT01516879|E1|Reported Event|Placebo|Participants received placebo subcutaneously once a month for 52 weeks in addition to background lipid-lowering therapy.
769973|NCT01516749|B1|Baseline|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
769974|NCT01516749|P1|Participant Flow|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
769975|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
769976|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
769977|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
769978|NCT01516749|O1|Outcome|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
769979|NCT01516749|E1|Reported Event|Anakinra|"All patients in this arm will receive the investigation drug anakinra once daily subcutaneously.~anakinra: Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks."
769980|NCT01516632|B3|Baseline|Total|Total of all reporting groups
769981|NCT01516632|B2|Baseline|The Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
769982|NCT01516632|B1|Baseline|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
769983|NCT01516632|P2|Participant Flow|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
769984|NCT01516632|P1|Participant Flow|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
769985|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
769986|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
770017|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770018|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
771195|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
769987|NCT01516632|O2|Outcome|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
769988|NCT01516632|O1|Outcome|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
769989|NCT01516632|O2|Outcome|Attention Matched Control|"Messages aimed at improving one's sleep and increasing one's fitness, along with general messages about the most well known health dangers of smoking. Messages sent on the same schedule as the intervention group.~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
769990|NCT01516632|O1|Outcome|Smoking Cesssation Via Text Messaging|"The 6-week smoking cessation program~SMS (Stop my Smoking) USA: Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again."
769991|NCT01516632|E2|Reported Event|Attention-Matched Control Group|Control group participants received a text-messaging program that was similar to the intervention program on the number of text messages received per day across the 6 weeks. Message content was aimed at improving one’s sleep and exercise habits within the context of how it would help the participant quit smoking. Messages were not tailored based on quitting stage (e.g., Pre-Quit vs. Early Quit) nor were Text Buddy and Text Crave components available to this group.
769992|NCT01516632|E1|Reported Event|Smoking Cessation Text Messaging|6-week smoking cessation program delivered via daily text messages. Stop My Smoking (SMS) USA is a text messaging–based smoking cessation program tailored to the experiences of young adult smokers. Content was tailored based on participant's stage of quitting (i.e. pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day. The intervention group had access to Text Buddy (another person in the program that a participant was assigned to so they could text one another for support anonymously and Text Crave (immediate, on demand messages aimed at helping the participant through a craving).
769993|NCT01516034|B1|Baseline|Treatment|Cupola tattoo removal treatment
769994|NCT01516034|P1|Participant Flow|Treatment|Cupola tattoo removal treatment
769995|NCT01516034|O1|Outcome|Treatment|Cupola tattoo removal treatment
769996|NCT01516034|E1|Reported Event|Treatment|Cupola tattoo removal treatment
769997|NCT01516008|B4|Baseline|Total|Total of all reporting groups
769998|NCT01516008|B3|Baseline|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
769999|NCT01516008|B2|Baseline|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770000|NCT01516008|B1|Baseline|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770001|NCT01516008|P3|Participant Flow|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770002|NCT01516008|P2|Participant Flow|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770003|NCT01516008|P1|Participant Flow|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770004|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770005|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770006|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770007|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770008|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770009|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770010|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770011|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770012|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770013|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770014|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770015|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770016|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770019|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770020|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770021|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770022|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770023|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770024|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770025|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770026|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770027|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770028|NCT01516008|O3|Outcome|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770029|NCT01516008|O2|Outcome|Tapentadol IR 50 mg|Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770030|NCT01516008|O1|Outcome|Placebo|Each participant received matching placebo once every 4 to 6 hours for 3 days
770031|NCT01516008|E3|Reported Event|Tapentadol IR 75 mg|Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
770035|NCT01515943|B3|Baseline|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
770036|NCT01515943|B2|Baseline|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the pr"
770037|NCT01515943|B1|Baseline|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
770038|NCT01515943|P3|Participant Flow|Placebo|"The placebo group will be assigned placebo home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Placebo home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5"
770039|NCT01515943|P2|Participant Flow|Near Target Push-up (NTP)|"The NTP group will be assigned placebo home-based computer vergence/accommodative therapy (5 minutes/day) plus near target push-ups (15 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Near target push-ups: At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times."
771976|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
770040|NCT01515943|P1|Participant Flow|Computer-based Therapy (CBT)|"The CBT group will be assigned active home-based computer vergence/accommodative therapy (15 minutes/day) plus placebo yoked prism flipper therapy (5 minutes/day) for a total of 20/minutes per day, 5 days per week for the 12-week treatment phase.~Active home-based computer vergence/accommodative therapy: At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.~Placebo yoked prism flippers: Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment"
770041|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770042|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770043|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770044|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770045|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770107|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
770046|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770047|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770048|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770049|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770050|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770051|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770052|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770053|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770054|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770055|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770056|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770057|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770058|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770059|NCT01515943|O2|Outcome|HB-C (Did Not Complete Computer-based Therapy Program)|Participants in the HB-C treatment group who did not complete the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving <15 stars for the jump vergence exercise.
770060|NCT01515943|O1|Outcome|HB-C (Completed Computer-based Therapy Program)|Participants in the HB-C treatment group who completed the computer vergence/accommodative therapy (CVAT) program at 12 weeks, defined as achieving at least 15 stars for the jump vergence exercise).
770061|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770062|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770063|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770064|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
771389|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
770065|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770066|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770067|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770068|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770069|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770070|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770071|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770072|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770108|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
814936|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
770073|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770074|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770075|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770076|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770077|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770078|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770079|NCT01515943|O3|Outcome|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770080|NCT01515943|O2|Outcome|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770081|NCT01515943|O1|Outcome|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770082|NCT01515943|E3|Reported Event|Placebo|Prescribed 15 minutes of placebo computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770083|NCT01515943|E2|Reported Event|Near Target Push-up (NTP)|Prescribed 15 minutes (in full or split into three 5-minute intervals) of a well-defined near target push-up (NTP) procedure and 5 minutes of placebo computer vergence/accommodative therapy (CVAT), 5 days per week for 12 weeks to be performed at home.
770084|NCT01515943|E1|Reported Event|Computer-based Therapy (CBT)|Prescribed 15 minutes of active computer vergence/accommodative therapy (CVAT) and 5 minutes of placebo flipper exercises, 5 days per week for 12 weeks to be performed at home.
770085|NCT01515891|B1|Baseline|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
770086|NCT01515891|P1|Participant Flow|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
770087|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
770088|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
770089|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
770090|NCT01515891|O1|Outcome|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
770091|NCT01515891|E1|Reported Event|BIA 9-1067|"90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).~BIA 9-1067: 90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose)."
770092|NCT01515865|B1|Baseline|Enrolled Population|
770093|NCT01515865|P3|Participant Flow|Placebo - (Randomized)|On Day 16 subjects received matching placebo.
770094|NCT01515865|P2|Participant Flow|Midodrine HCl - (Randomized)|On Day 16 subjects received over-encapsulated midodrine HCl tablets (equivalent to their previously prescribed dose).
770134|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
771520|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
770095|NCT01515865|P1|Participant Flow|Midodrine HCl - (Open-label)|On the morning of Day -1, subjects took their usual morning dose of midodrine HCl, using their own midodrine HCl supplies at approximately the same time before rising that they would normally take their morning dose. On the morning of Day 1, subjects had their usual morning dose of midodrine HCl withheld. On Day 2, all eligible subjects continued on their midodrine HCl dose regimen over at least 14 days, using study-supplied investigational product.
770096|NCT01515865|O2|Outcome|Placebo|Matching placebo treatment (utilizing the same number of placebo capsules that would be required to constitute their midodrine HCl dose).
770097|NCT01515865|O1|Outcome|Midodrine HCl|Over-encapsulated midodrine HCl tablet at the subjects previously prescribed dose level.
770098|NCT01515865|E4|Reported Event|Placebo - Randomized (Part C)|over-encapsulated randomized matching placebo
770099|NCT01515865|E3|Reported Event|Midodrine HCl - Randomized (Part C)|over-encapsulated randomized dose (Part C) at subjects current dose level
770100|NCT01515865|E2|Reported Event|Midodrine HCl - Open-label (Part B)|open-label study-supplied (Part B) dose at subjects current dose level
770101|NCT01515865|E1|Reported Event|Midodrine HCl - Open-label (Part A)|dose at the subjects current dose level
770102|NCT01515696|B3|Baseline|Total|Total of all reporting groups
770103|NCT01515696|B2|Baseline|Sterile Water|infants receive 9ml/kg sterile water
770104|NCT01515696|B1|Baseline|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
770105|NCT01515696|P2|Participant Flow|Sterile Water|infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube
770106|NCT01515696|P1|Participant Flow|Gastrografin|infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube
770109|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
770110|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
770111|NCT01515696|O2|Outcome|Sterile Water|infants receive 9ml/kg sterile water
770112|NCT01515696|O1|Outcome|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
770113|NCT01515696|E2|Reported Event|Sterile Water|infants receive 9ml/kg sterile water
770114|NCT01515696|E1|Reported Event|Gastrografin|infants receive 3ml/kg Gastrografin + 6ml/kg sterile water
770115|NCT01515657|B1|Baseline|All Study Participants|All patients that received at least 1 dose of study drug under the study protocol.
770116|NCT01515657|P3|Participant Flow|EC Aspirin First, Then PL2200 Aspirin, Then IR Aspirin Tablets|"First Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days"
770117|NCT01515657|P2|Participant Flow|IR Aspirin Tablets First, Then EC Aspirin, Then PL2200 Aspirin|"First Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
770118|NCT01515657|P1|Participant Flow|PL2200 Aspirin First, Then IR Aspirin Tablets, Then EC Aspirin|"First Intervention Period:~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Second Intervention Period:~IR (immediate-release) aspirin tablets: 325 mg aspirin; once per day for 3 days (after 2-week washout period)~Third Intervention Period:~EC (enteric coated) aspirin: 325 mg aspirin; once per day for 3 days"
770119|NCT01515657|O3|Outcome|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
770120|NCT01515657|O2|Outcome|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
770121|NCT01515657|O1|Outcome|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
770122|NCT01515657|E3|Reported Event|Enteric-coated Aspirin Caplets|"Active comparator; crossover design~Enteric-coated aspirin caplets: 325 mg aspirin; once per day for 3 days"
770123|NCT01515657|E2|Reported Event|Immediate-Release Aspirin Tablets|"Active comparator; crossover design~Immediate-Release Aspirin Tablets: 325 mg aspirin; once per day for 3 days"
770124|NCT01515657|E1|Reported Event|PL2200 Aspirin Capsules|"Investigational drug arm; crossover design~PL2200 Aspirin Capsules: 325 mg aspirin; once per day for 3 days"
770125|NCT01515566|B3|Baseline|Total|Total of all reporting groups
770126|NCT01515566|B2|Baseline|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
770127|NCT01515566|B1|Baseline|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl or Placebo. Questionnaires completed at baseline and after study visit.
770128|NCT01515566|P2|Participant Flow|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Placebo. Questionnaires completed at baseline and after study visit.
770129|NCT01515566|P1|Participant Flow|Fentanyl|Fentanyl subcutaneous (SQ) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test; 6 minute walk test (6MWT) at baseline and 15 minutes after Fentanyl. Questionnaires completed at baseline and after study visit.
770130|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
770131|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
770132|NCT01515566|O2|Outcome|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test; 6MWT at baseline and 15 minutes after Placebo.
770133|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
770135|NCT01515566|O1|Outcome|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of MEDD 15 minutes before walk test; 6MWT at baseline and 15 minutes after Fentanyl.
770136|NCT01515566|E2|Reported Event|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Placebo.
770137|NCT01515566|E1|Reported Event|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before walk test. 6 minute walk test at baseline and 15 minutes after Fentanyl.
770138|NCT01515540|B3|Baseline|Total|Total of all reporting groups
770139|NCT01515540|B2|Baseline|Control|placebo patch
770140|NCT01515540|B1|Baseline|Lidocaine|5% lidoderm patch
770141|NCT01515540|P2|Participant Flow|Control|placebo patch
770142|NCT01515540|P1|Participant Flow|Lidocaine|5% lidoderm patch
770143|NCT01515540|O2|Outcome|Control|placebo patch
770144|NCT01515540|O1|Outcome|Lidocaine|5% lidoderm patch
770145|NCT01515540|E2|Reported Event|Control|placebo patch
770146|NCT01515540|E1|Reported Event|Lidocaine|5% lidoderm patch
770147|NCT01515488|B3|Baseline|Total|Total of all reporting groups
770148|NCT01515488|B2|Baseline|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
770149|NCT01515488|B1|Baseline|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
770150|NCT01515488|P2|Participant Flow|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
770663|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770151|NCT01515488|P1|Participant Flow|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
770152|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
770153|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
770154|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
770155|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
770156|NCT01515488|O2|Outcome|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
770157|NCT01515488|O1|Outcome|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
770158|NCT01515488|E2|Reported Event|Self-triage Kiosk|"Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)~Self-triage kiosk : Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)"
770159|NCT01515488|E1|Reported Event|Nurse-initiated Triage|"Nurse-initiated triage for obtaining medical history and presenting problem(s)~Nurse-initiated triage : Nurse-assisted triage for obtaining medical history and presenting problem(s)"
770160|NCT01515423|B3|Baseline|Total|Total of all reporting groups
770161|NCT01515423|B2|Baseline|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770162|NCT01515423|B1|Baseline|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770163|NCT01515423|P3|Participant Flow|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770164|NCT01515423|P2|Participant Flow|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770165|NCT01515423|P1|Participant Flow|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
770166|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770167|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770168|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770169|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770170|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770171|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770172|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770202|NCT01515345|E1|Reported Event|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
770203|NCT01515306|B3|Baseline|Total|Total of all reporting groups
770173|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770174|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770175|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770176|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770177|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770178|NCT01515423|O2|Outcome|Double Blind: Paliperidone Palmitate 1 Month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770179|NCT01515423|O1|Outcome|Double Blind: Paliperidone Palmitate 3 Month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770180|NCT01515423|E3|Reported Event|Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.
770181|NCT01515423|E2|Reported Event|Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation|Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.
770182|NCT01515423|E1|Reported Event|Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation|Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.
770183|NCT01515410|B1|Baseline|Overall Study|DM-1992 first, then Sinemet IR; Sinemet IR first, then DM-1992
770184|NCT01515410|P2|Participant Flow|Sinemet IR First, Then DM-1992|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD) first, then DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
770185|NCT01515410|P1|Participant Flow|DM-1992 First, Then Sinemet IR|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD) first, then Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
770186|NCT01515410|O2|Outcome|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
770187|NCT01515410|O1|Outcome|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
770188|NCT01515410|E2|Reported Event|Sinemet IR|Sinemet IR, an Immediate-release (IR) tablet containing 25mg carbidopa (CD) and 100mg levodopa (LD)
770189|NCT01515410|E1|Reported Event|DM-1992|DM-1992, a gastric-retentive extended-release tablet containing 72.5mg carbidopa (CD) and 230mg levodopa (LD)
770190|NCT01515345|B3|Baseline|Total|Total of all reporting groups
770191|NCT01515345|B2|Baseline|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
770192|NCT01515345|B1|Baseline|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
770193|NCT01515345|P2|Participant Flow|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
770194|NCT01515345|P1|Participant Flow|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
770195|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
770196|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
770197|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
770198|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
770199|NCT01515345|O2|Outcome|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
770200|NCT01515345|O1|Outcome|Standard Therapy|standard dual antiplatelet therapy after PCI for all patient populations (stable CVD and ACS)
770201|NCT01515345|E2|Reported Event|Individualized Therapy|dual antiplatelet therapy modified according to clopidogrel on-treatment platelet reactivity measured by Multiplate Analyzer
770204|NCT01515306|B2|Baseline|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
770205|NCT01515306|B1|Baseline|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
770206|NCT01515306|P2|Participant Flow|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
770207|NCT01515306|P1|Participant Flow|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
770208|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
770209|NCT01515306|O1|Outcome|Part A: Ramucirumab (IMC-1121B) (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
770210|NCT01515306|O1|Outcome|Part B: Ramucirumab (IMC-1121B) (Cycle 1)|Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.
770211|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
770212|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
770213|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 2)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle."
770214|NCT01515306|O1|Outcome|Part A: Paclitaxel (Cycle 1)|Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.
770215|NCT01515306|E2|Reported Event|Part B: Ramucirumab (IMC-1121B) With or Without Paclitaxel|"Cycle 1: ramucirumab (IMC-1121B) 8 mg/kg administered as monotherapy on Day 1 of 3-week cycle.~Cycle 2 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~*After Cycle 1 (mandatory pharmacokinetic phase) is completed, participants may continue to receive ramucirumab (IMC-1121B) monotherapy or combination therapy with paclitaxel as described in Part A."
770216|NCT01515306|E1|Reported Event|Part A: Paclitaxel and Ramucirumab (IMC-1121B)|"Cycle 1: paclitaxel 80 milligrams/square meter (mg/m²) administered on Day 1 of 2-week cycle.~Cycle 2: ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of 4-week cycle.~Cycle 3 and beyond: ramucirumab (IMC-1121B) 8 mg/kg administered on Day 1 and Day 15, paclitaxel 80 mg/m² administered on Day 1, Day 8 and Day 15 of each 4-week cycle."
770217|NCT01515189|B3|Baseline|Total|Total of all reporting groups
770218|NCT01515189|B2|Baseline|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770219|NCT01515189|B1|Baseline|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770220|NCT01515189|P2|Participant Flow|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770221|NCT01515189|P1|Participant Flow|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770222|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770223|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770224|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770225|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770226|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770227|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770228|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770229|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
815994|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
770230|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770231|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770232|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770233|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770234|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770235|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770236|NCT01515189|O2|Outcome|Ipilimumab (3 mg/kg)|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770237|NCT01515189|O1|Outcome|Ipilimumab (10 mg/kg)|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770238|NCT01515189|E2|Reported Event|3 MG/KG IPILIMUMAB|Ipilimumab 3 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770239|NCT01515189|E1|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg solution intravenously once every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
770240|NCT01515046|B1|Baseline|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770241|NCT01515046|P1|Participant Flow|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770242|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770243|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770264|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770276|NCT01514734|O1|Outcome|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
770244|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770245|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770246|NCT01515046|O1|Outcome|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770247|NCT01515046|E1|Reported Event|Gemcitabine With Escalating IV Ascorbate|"Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off. Ascorbic Gemcitabine (1000 mg/m2) weekly for three weeks and then one week off.~Ascorbate (vitamin C) given twice weekly, escalating doses weekly. Week 1: 15 grams ascorbate / infusion for two infusions. Doses are then escalated in 25 gram increments until therapeutic window is achieved (350 mg/dL or above). Dose is then held at that level for the full cycle.~Gemcitabine with escalating ascorbic acid: Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
770248|NCT01514864|B3|Baseline|Total|Total of all reporting groups
770249|NCT01514864|B2|Baseline|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770250|NCT01514864|B1|Baseline|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770251|NCT01514864|P2|Participant Flow|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770252|NCT01514864|P1|Participant Flow|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770253|NCT01514864|O1|Outcome|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer (NSCLC) received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
770254|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770255|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770256|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770257|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770258|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770259|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770260|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770261|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770262|NCT01514864|O2|Outcome|Dasatinib, 140 mg (NSCLC With DDR2 Mutation)|Participants with NSCLC and a discoidin domain receptor 2 (DDR2) mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770263|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) and an inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770265|NCT01514864|O1|Outcome|Dasatinib, 140 mg (NSCLC With Inactivating B-RAF Mutation)|Participants with nonsmall-cell lung cancer (NSCLC) with inactivating B-RAF mutation received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred
770266|NCT01514864|E1|Reported Event|Dasatinib, 140 mg|Participants with nonsmall-cell lung cancer received dasatinib, 140 mg, once daily as a tablet until unacceptable toxicity or disease progression occurred. Data from both arms were combined for safety reporting, because the safety profile of dasatinib should not have be affected by the type of mutation in the tumor. In addition, pooling the data from both arms increased the robustness of the data set.
770267|NCT01514760|B1|Baseline|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
770281|NCT01514630|E1|Reported Event|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
770282|NCT01514513|B3|Baseline|Total|Total of all reporting groups
770283|NCT01514513|B2|Baseline|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
770268|NCT01514760|P1|Participant Flow|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan : The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
770269|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
770270|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
770271|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
770272|NCT01514760|O1|Outcome|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
770273|NCT01514760|E1|Reported Event|Mobile-based Asthma Action Plan|"The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts.~Mobile-based Asthma Action Plan: The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
770274|NCT01514734|B1|Baseline|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
770275|NCT01514734|P1|Participant Flow|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
770277|NCT01514734|E1|Reported Event|AZARGA|Brinzolamide/timolol maleate fixed combination, one drop self-administered in study eye(s) twice a day for 8 weeks
770278|NCT01514630|B1|Baseline|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
770279|NCT01514630|P1|Participant Flow|Creatine Monohydrate|14 female depressed methamphetamine users received 5 grams of creatine monohydrate daily for eight weeks. Participants were seen twice weekly after creatine was initiated. All participants met SCID-I/P criteria for lifetime methamphetamine dependence or for current methamphetamine dependence. After consent was obtained, the principal investigator administered the SCID-I/P and HAMD, and if a female met SCID-I/P criteria and scored > 15 on the HAMD, the following additional screening data were collected: Beck Anxiety Inventory, C-SSRS , vital signs, concomitant medications, self-report drug use over the past 48 hours for cigarettes, alcohol, cocaine, methamphetamine, marijuana, heroin and prescription controlled substances, urine drug screen for methamphetamine, opiates, benzodiazepines, marijuana and cocaine, pregnancy testing and attendance in outpatient treatment and/or 12 step programs.
770280|NCT01514630|O1|Outcome|Creatine Monohydrate|"14 female depressed methamphetamine users will receive 5 grams of creatine monohydrate daily for eight weeks.~Creatine monohydrate: Five grams of creatine monohydrate will be administered for eight weeks."
770284|NCT01514513|B1|Baseline|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
770285|NCT01514513|P2|Participant Flow|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
770286|NCT01514513|P1|Participant Flow|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
770287|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
770288|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
770289|NCT01514513|O2|Outcome|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
770290|NCT01514513|O1|Outcome|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
770291|NCT01514513|E2|Reported Event|Nix Creme Rinse, 1% Permethrin|1% permethrin creme rinse: Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
770292|NCT01514513|E1|Reported Event|Licefreee Spray|Licefreee Spray: Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
770293|NCT01514461|B4|Baseline|Total|Total of all reporting groups
770294|NCT01514461|B3|Baseline|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770295|NCT01514461|B2|Baseline|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770296|NCT01514461|B1|Baseline|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770297|NCT01514461|P3|Participant Flow|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770298|NCT01514461|P2|Participant Flow|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770299|NCT01514461|P1|Participant Flow|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770300|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770301|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770302|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770303|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
815995|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
770304|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770305|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770306|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770307|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770308|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770309|NCT01514461|O2|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770310|NCT01514461|O1|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770311|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770312|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770353|NCT01514240|B1|Baseline|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770612|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770313|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770314|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770315|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770316|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770317|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770318|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770319|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770320|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770321|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770322|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770323|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770324|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770325|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770354|NCT01514240|P2|Participant Flow|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770526|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770326|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770327|NCT01514461|O2|Outcome|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770328|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770329|NCT01514461|O3|Outcome|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770330|NCT01514461|O2|Outcome|LCQ908 20mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770331|NCT01514461|O1|Outcome|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770332|NCT01514461|E3|Reported Event|LCQ908 40 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 40 mg active tablet + one LCQ908 placebo matching to 20mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770333|NCT01514461|E2|Reported Event|LCQ908 20 mg|In period II (0-12 weeks) double-blind treatment: one LCQ908 20 mg active tablet + one LCQ908 placebo matching to 40mg tablet, once daily. No dose titration allowed. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen will follow. Following decision to down titrate: one LCQ908 10 mg active tablet + one LCQ908 placebo matching to 40 mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet will be followed and recorded in patient diary.
770334|NCT01514461|E1|Reported Event|Placebo|In period II (0-12 weeks) double-blind treatment: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet, once daily. In period III (12-52 weeks) double blind treatment: Without down titration, the period II dosing regimen was followed. Following decision to down titrate: one LCQ908 placebo matching to 40mg tablet + one LCQ908 placebo matching to 20mg tablet + one LCQ908 placebo matching to 10mg tablets, once daily. A low fat diet was followed and recorded in patient diary.
770335|NCT01514422|B1|Baseline|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
770336|NCT01514422|P1|Participant Flow|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
770337|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
770338|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
770339|NCT01514422|O1|Outcome|Minocycline|Minocycline for 8 weeks
770340|NCT01514422|E1|Reported Event|Minocycline|Minocycline for 8 weeks
770341|NCT01514318|B1|Baseline|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
770342|NCT01514318|P1|Participant Flow|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
770343|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
770344|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
770345|NCT01514318|O1|Outcome|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
770346|NCT01514318|E1|Reported Event|Revelation|Subjects who received the Revelation Hip Stem prior to 2002 and have agreed to come into the office for a single visit.
770347|NCT01514292|B1|Baseline|Real Time Continuous Glucose Monitoring System|Real Time Continuous Glucose Monitoring(CGM) System Wearing for up to 7 days.
770348|NCT01514292|P1|Participant Flow|CGM Device|Dexcom CGM Device Wearing for up to 7 days
770349|NCT01514292|O1|Outcome|Real Time Continous Glucose Monitoring System|Real Time Continous Glucose Monitoring System Wearing for up to 7 days
770350|NCT01514292|E1|Reported Event|CGM Device|Dexcom CGM Device Wearing for up to 7 days
770351|NCT01514240|B3|Baseline|Total|Total of all reporting groups
770352|NCT01514240|B2|Baseline|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
791989|NCT01433263|B1|Baseline|30mg/kg BYM338|
770355|NCT01514240|P1|Participant Flow|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770356|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770357|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770358|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770359|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770360|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770361|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770362|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770363|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770364|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770365|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770366|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770367|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770368|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770369|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770370|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770371|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770372|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770373|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770374|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770375|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770376|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770377|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770378|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770379|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770380|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770381|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770524|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770382|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770383|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770384|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770385|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770386|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770387|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770388|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770389|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770390|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770391|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770392|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770393|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770394|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770395|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770396|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770397|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770398|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770399|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770400|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770401|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770402|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770403|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770404|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770405|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770406|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770407|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770408|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770525|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770409|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770410|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770411|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770412|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770413|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770414|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770415|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770416|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770417|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770418|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770419|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770420|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770421|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770422|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770423|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770424|NCT01514240|O2|Outcome|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770425|NCT01514240|O1|Outcome|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770426|NCT01514240|E2|Reported Event|Mesalazine 3g + D9421-C Placebo|Patients randomised to Mesalazine 3 g took 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
770427|NCT01514240|E1|Reported Event|D9421-C 9mg + Mesalazine Placebo|Patients randomised to D9421-C 9 mg took 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
770428|NCT01514162|B1|Baseline|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
770429|NCT01514162|P1|Participant Flow|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
770430|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
770431|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
770432|NCT01514162|O1|Outcome|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
770433|NCT01514162|E1|Reported Event|Trifecta Valve Group|Subjects implanted with a Trifecta valve.
770434|NCT01514136|B3|Baseline|Total|Total of all reporting groups
770435|NCT01514136|B2|Baseline|Flat Product Users|Subjects who usually use a flat product
770436|NCT01514136|B1|Baseline|Convex Product Users|Subjects who usually use a convex product
770437|NCT01514136|P8|Participant Flow|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
770438|NCT01514136|P7|Participant Flow|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
770439|NCT01514136|P6|Participant Flow|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
791990|NCT01433263|P2|Participant Flow|Placebo / Late 30mg/kg BYM338|
770440|NCT01514136|P5|Participant Flow|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
770441|NCT01514136|P4|Participant Flow|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test D was a newly developed concept by Coloplast A/S for the first round."
770442|NCT01514136|P3|Participant Flow|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test C was a newly developed concept by Coloplast A/S for the first round."
770443|NCT01514136|P2|Participant Flow|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test B was a newly developed concept by Coloplast A/S for the first round."
770444|NCT01514136|P1|Participant Flow|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Therefore the participant flow is divided by the test products and not for each period.~Test A was a newly developed concept by Coloplast A/S for the first round."
770445|NCT01514136|O16|Outcome|Test D* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
770446|NCT01514136|O15|Outcome|Test C* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
770447|NCT01514136|O14|Outcome|Test B* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
770448|NCT01514136|O13|Outcome|Test A* - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
770449|NCT01514136|O12|Outcome|Test D - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
770450|NCT01514136|O11|Outcome|Test C - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
770451|NCT01514136|O10|Outcome|Test B - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
770452|NCT01514136|O9|Outcome|Test A - Flat Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
770453|NCT01514136|O8|Outcome|Test D* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
770454|NCT01514136|O7|Outcome|Test C* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
770455|NCT01514136|O6|Outcome|Test B* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
791991|NCT01433263|P1|Participant Flow|30mg/kg BYM338|
770456|NCT01514136|O5|Outcome|Test A* - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
770457|NCT01514136|O4|Outcome|Test D - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test D was a newly developed concept by Coloplast A/S for the first round."
770458|NCT01514136|O3|Outcome|Test C - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test C was a newly developed concept by Coloplast A/S for the first round."
770459|NCT01514136|O2|Outcome|Test B - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test B was a newly developed concept by Coloplast A/S for the first round."
770619|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770460|NCT01514136|O1|Outcome|Test A - Convex Product Users|"The investigation was set up with two different periods. In the first period the newly developed concepts, Test A-D, were tested. Based on the results, four new concepts were developed and tested, Test A* - D*.~Two subject populations were included in the investigation: subjects using flat ostomy products and subjects using convex ostomy products.~Test A was a newly developed concept by Coloplast A/S for the first round."
770461|NCT01514136|E8|Reported Event|Test D*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D* was a newly developed optimized concept by Coloplast A/S for the second round."
770462|NCT01514136|E7|Reported Event|Test C*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C* was a newly developed optimized concept by Coloplast A/S for the second round."
770463|NCT01514136|E6|Reported Event|Test B*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B* was a newly developed optimized concept by Coloplast A/S for the second round."
770464|NCT01514136|E5|Reported Event|Test A*|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A* was a newly developed optimized concept by Coloplast A/S for the second round."
770465|NCT01514136|E4|Reported Event|Test D|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test D was a newly developed concept by Coloplast A/S for the first round."
770466|NCT01514136|E3|Reported Event|Test C|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test C was a newly developed concept by Coloplast A/S for the first round."
770467|NCT01514136|E2|Reported Event|Test B|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test B was a newly developed concept by Coloplast A/S for the first round."
770468|NCT01514136|E1|Reported Event|Test A|"The investigation was set up with two different periods. In the first period the newly developed concepts Test A-D were tested based on the results four new products were developed and tested concept Test A* - D*.~Test A was a newly developed concept by Coloplast A/S for the first round."
770469|NCT01513902|B4|Baseline|Total|Total of all reporting groups
770470|NCT01513902|B3|Baseline|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770471|NCT01513902|B2|Baseline|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770472|NCT01513902|B1|Baseline|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770473|NCT01513902|P3|Participant Flow|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770474|NCT01513902|P2|Participant Flow|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770475|NCT01513902|P1|Participant Flow|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770613|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770476|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770477|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770478|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770479|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770480|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770620|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770481|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770482|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770483|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770484|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770485|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770486|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770487|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770488|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770489|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770490|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770491|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770492|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770493|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770494|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770495|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770496|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770497|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770498|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770499|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770500|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770501|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770502|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770503|NCT01513902|O3|Outcome|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770504|NCT01513902|O2|Outcome|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770505|NCT01513902|O1|Outcome|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770506|NCT01513902|E3|Reported Event|Cohort III: 2 Years to <6 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 4.5 mL) for participants weighing <30 kg. Participants weighing >=30 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770507|NCT01513902|E2|Reported Event|Cohort II: 6 Years to <12 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 mL to 3 mL) for participants weighing <40 kg, oral tablets (5 mg) were used for participants weighing >=40 kg. Participants with a body weight of >=40 kg had the option of taking oral solution (5 mL) or tablets (5 mg).
770508|NCT01513902|E1|Reported Event|Cohort I: 12 Years to <18 Years|CP-690,550 was administered orally, twice daily as oral solution (ranging from 1 milliliter [mL] to 3 mL) for children weighing <40 kilogram (kg) or twice daily as oral tablets (5 milligram [mg]) for participants weighing greater than or equal to (>=) 40 kg. Participants who were unable to swallow tablets had the option of taking oral solution.
770509|NCT01513590|B3|Baseline|Total|Total of all reporting groups
770510|NCT01513590|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770511|NCT01513590|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770512|NCT01513590|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770513|NCT01513590|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770514|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770515|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770516|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770517|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770518|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770519|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770520|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770521|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770522|NCT01513590|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770523|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770527|NCT01513590|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770528|NCT01513590|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with metformin. BIAsp 30 was given with the breakfast meal and main evening meal.
770529|NCT01513590|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with metformin. IDegAsp was given with the breakfast meal and main evening meal.
770530|NCT01513473|B3|Baseline|Total|Total of all reporting groups
770531|NCT01513473|B2|Baseline|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770532|NCT01513473|B1|Baseline|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770533|NCT01513473|P2|Participant Flow|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770534|NCT01513473|P1|Participant Flow|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770535|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770536|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770537|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770538|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770539|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770540|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770541|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770542|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770543|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770544|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770545|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770546|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770547|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770621|NCT01513317|E2|Reported Event|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770622|NCT01513317|E1|Reported Event|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770548|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770549|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770550|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770551|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770552|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770553|NCT01513473|O2|Outcome|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770554|NCT01513473|O1|Outcome|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770555|NCT01513473|E2|Reported Event|IDet + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDet OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDet was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDet.
770556|NCT01513473|E1|Reported Event|IDeg + IAsp|Subjects from 1 to 18 years of age were randomised into treatment arms, IDeg OD as basal insulin and IAsp as mealtime bolus insulin for a period of 26 weeks followed by extension trial for a period of 26 weeks. IDeg was given once a day at approximately the same time of the day. Basal and bolus insulin titration was done according to the lowest pre-breakfast SMPG value measured on the three days prior to the visit/ phone contact for IDeg.
770557|NCT01513460|B4|Baseline|Total|Total of all reporting groups
770558|NCT01513460|B3|Baseline|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770559|NCT01513460|B2|Baseline|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770560|NCT01513460|B1|Baseline|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770709|NCT01513148|B1|Baseline|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
770561|NCT01513460|P3|Participant Flow|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770562|NCT01513460|P2|Participant Flow|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770623|NCT01513291|B3|Baseline|Total|Total of all reporting groups
770624|NCT01513291|B2|Baseline|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770664|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770563|NCT01513460|P1|Participant Flow|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770564|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770565|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770566|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770567|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770568|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770569|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770570|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770571|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770572|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770573|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770574|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770606|NCT01513317|B1|Baseline|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
771977|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
770575|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770576|NCT01513460|O3|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770577|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770578|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770579|NCT01513460|O2|Outcome|NVA237/Tiotropium+Flu/Sal|NVA237+Flu/Sal and Tiotropium+Flu/Sal arms
770580|NCT01513460|O1|Outcome|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770581|NCT01513460|O2|Outcome|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770582|NCT01513460|O1|Outcome|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770583|NCT01513460|E3|Reported Event|Flu/Sal|Placebo (NVA237 placebo + Tiotropium placebo + Flu/Sal). Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770584|NCT01513460|E2|Reported Event|Tiotropium + Flu/Sal|Tiotropium 18µg once daily (NVA237 placebo + Tiotropium + Flu/Sal). Tiotropium 18 μg o.d. delivered via a proprietary inhalation device plus Placebo to NVA237 o.d. delivered via single-dose dry-powder inhaler (SDDPI) plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770585|NCT01513460|E1|Reported Event|NVA237 + Fluticasone/Salmeterol (Flu/Sal)|NVA237 50 µg once daily (NVA237 + Tiotropium placebo + Flu/Sal). NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI) o.d. plus Placebo to tiotropium o.d. delivered via a proprietary inhalation device plus Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device. In addition, at Visit 1, all participants were provided with a short acting β2-agonist (salbutamol) which they were instructed to use throughout the study as rescue medication.
770586|NCT01513447|B3|Baseline|Total|Total of all reporting groups
770587|NCT01513447|B2|Baseline|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770588|NCT01513447|B1|Baseline|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770607|NCT01513317|P2|Participant Flow|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770608|NCT01513317|P1|Participant Flow|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770609|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770610|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770589|NCT01513447|P2|Participant Flow|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770625|NCT01513291|B1|Baseline|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770665|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770590|NCT01513447|P1|Participant Flow|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770591|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770592|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770593|NCT01513447|O2|Outcome|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770594|NCT01513447|O1|Outcome|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770595|NCT01513447|E2|Reported Event|Normal Saline Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770596|NCT01513447|E1|Reported Event|Sterile Water Injection|"In the sitting position, study subjects will receive a total of 0.4 mL of “study drug” via four intracutaneous injections: bilateral injections at the posterior superior iliac spine and bilateral injections at 1 cm medial and 1-2 cm inferior to the first point.~Intracutaneous injections: Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds."
770597|NCT01513330|B1|Baseline|Entire Study Population|Entire study population = all participants enrolled in the study
770598|NCT01513330|P2|Participant Flow|First Standard Care, Then SenSura Mio|The subjects first test Standard Care Ostomy product 1 piece closed bags (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)and after cross-over test SenSura Mio 1-piece closed bags.
770599|NCT01513330|P1|Participant Flow|First SenSura Mio, Then Standard Care|The subjects first test SenSura Mio : Ostomy product - 1 piece closed bag and thereafter cross-over and test Standard Care (Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima)
770600|NCT01513330|O2|Outcome|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
770601|NCT01513330|O1|Outcome|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
770602|NCT01513330|E2|Reported Event|Standard Care|Standard Care : Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
770603|NCT01513330|E1|Reported Event|SenSura Mio|SenSura Mio : Ostomy product - 1 piece closed bag
770604|NCT01513317|B3|Baseline|Total|Total of all reporting groups
770605|NCT01513317|B2|Baseline|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770611|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770614|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770615|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770616|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770617|NCT01513317|O2|Outcome|Placebo|Placebo administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770618|NCT01513317|O1|Outcome|Siltuximab|15 mg/kg of siltuximab administered as a 1-hour infusion every 4 weeks + best supportive care (BSC)
770626|NCT01513291|P5|Participant Flow|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770627|NCT01513291|P4|Participant Flow|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770628|NCT01513291|P3|Participant Flow|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
770629|NCT01513291|P2|Participant Flow|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770630|NCT01513291|P1|Participant Flow|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770631|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770632|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770633|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770634|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770635|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770636|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770637|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770638|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770639|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
770640|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770641|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770642|NCT01513291|O5|Outcome|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, received double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770643|NCT01513291|O4|Outcome|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770644|NCT01513291|O3|Outcome|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
770645|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770646|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770647|NCT01513291|O2|Outcome|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770648|NCT01513291|O1|Outcome|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770649|NCT01513291|E5|Reported Event|Run-out Period: Placebo / Placebo|Participants who received placebo and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770650|NCT01513291|E4|Reported Event|Run-out Period: MK-6096 / Placebo|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind placebo, two tablets, orally, once daily for 2 weeks in the Run-out Period.
770651|NCT01513291|E3|Reported Event|Run-out Period: MK-6096 / MK-6096|Participants who received MK-6096 and completed the Treatment Period, and were randomized to receive double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 2 weeks in the Run-out Period.
770652|NCT01513291|E2|Reported Event|Treatment Period: Placebo|Participants received double-blind placebo, two tablets, orally, once daily for 12 weeks in the Treatment Period
770653|NCT01513291|E1|Reported Event|Treatment Period: MK-6096|Participants received double-blind MK-6096, two 5 mg tablets (10 mg dose), orally, once daily for 12 weeks in the Treatment Period
770654|NCT01513239|B4|Baseline|Total|Total of all reporting groups
770655|NCT01513239|B3|Baseline|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770656|NCT01513239|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770657|NCT01513239|B1|Baseline|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770658|NCT01513239|P3|Participant Flow|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770659|NCT01513239|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770660|NCT01513239|P1|Participant Flow|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770661|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770662|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
816603|NCT01339897|O4|Outcome|Placebo|Non-Active
770666|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770667|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770668|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770669|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770670|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770671|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770672|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770673|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770674|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770675|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770676|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770677|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770678|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770679|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770680|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770681|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770682|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770683|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770684|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770685|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770686|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770687|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770688|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770689|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770690|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770691|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770692|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770693|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770694|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770695|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770696|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770697|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770698|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770699|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770700|NCT01513239|O3|Outcome|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770701|NCT01513239|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770702|NCT01513239|O1|Outcome|MK-3415A + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415A + SOC for CDI
770703|NCT01513239|E4|Reported Event|MK-3415 + SOC|Single IV infusion of 10 mg/kg MK-3415 + SOC for CDI
770704|NCT01513239|E3|Reported Event|Placebo + SOC|Normal saline IV infusion (0.9% sodium chloride) + SOC for CDI
770705|NCT01513239|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
770706|NCT01513239|E1|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
770707|NCT01513148|B3|Baseline|Total|Total of all reporting groups
770708|NCT01513148|B2|Baseline|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
771978|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
770710|NCT01513148|P2|Participant Flow|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
770711|NCT01513148|P1|Participant Flow|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
770712|NCT01513148|O14|Outcome|Sham Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770713|NCT01513148|O13|Outcome|Sham Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770714|NCT01513148|O12|Outcome|Sham Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770715|NCT01513148|O11|Outcome|Sham Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770716|NCT01513148|O10|Outcome|Sham Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770717|NCT01513148|O9|Outcome|Sham Temp Time 0|Temperature immediately following the application of sham superluminous diodes light irradiation over the superficial radial nerve
770718|NCT01513148|O8|Outcome|Sham Temp Pretreatment|Temperature prior to the application of sham super luminous diodes light irradiation over the superficial radial nerve
770719|NCT01513148|O7|Outcome|Light Temp Time 10|Temperature 10 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770720|NCT01513148|O6|Outcome|Light Temp Time 8|Temperature 8 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770814|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
770721|NCT01513148|O5|Outcome|Light Temp Time 6|Temperature 6 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770722|NCT01513148|O4|Outcome|Light Temp Time 4|Temperature 4 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770723|NCT01513148|O3|Outcome|Light Temp Time 2|Temperature 2 minutes following the application of superluminous diodes light irradiation over the superficial radial nerve
770724|NCT01513148|O2|Outcome|Light Temp Time 0|Temperature immediately following the application of superluminous diodes light irradiation over the superficial radial nerve
770725|NCT01513148|O1|Outcome|Light Temp Pretreatment|Temperature prior to the application of super luminous diodes light irradiation over the superficial radial nerve
770726|NCT01513148|O14|Outcome|Sham NPL Pretreatment|NPL for Sham treatment group (Sham Superluminous diode light therapy) at baseline (pretreatment)
770727|NCT01513148|O13|Outcome|Sham NPL Time 10|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 10 minutes
770728|NCT01513148|O12|Outcome|Sham NPL Time 8|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 8 minutes
770729|NCT01513148|O11|Outcome|Sham NPL Time 6|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 6 minutes
770730|NCT01513148|O10|Outcome|Sham NPL Time 4|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 4 minutes
770731|NCT01513148|O9|Outcome|Sham NPL Time 2|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 2 minutes
770732|NCT01513148|O8|Outcome|Sham NPL Time 0|NPL for Sham treatment group (Sham Superluminous diode light therapy) at time 0 minutes
770733|NCT01513148|O7|Outcome|Light NPL Time 10|NPL for treatment group (Superluminous diode light therapy) at time 10 minutes
770734|NCT01513148|O6|Outcome|Light NPL Time 8|NPL for treatment group (Superluminous diode light therapy) at time 8 minutes
770735|NCT01513148|O5|Outcome|Light NPL Time 6|NPL for treatment group (Superluminous diode light therapy) at time 6 minutes
770736|NCT01513148|O4|Outcome|Light NPL Time 4|NPL for treatment group (Superluminous diode light therapy) at time 4 minutes
770737|NCT01513148|O3|Outcome|Light NPL Time 2|NPL for treatment group (Superluminous diode light therapy) at time 2 minutes
770738|NCT01513148|O2|Outcome|Light NPL Time 0|NPL for treatment group (Superluminous diode light therapy) at time 0 minutes
770739|NCT01513148|O1|Outcome|Light NPL Pre-treatment|NPL for treatment group (Superluminous diode light therapy) at baseline (pre-treatment)
770740|NCT01513148|O14|Outcome|Sham NCV Time 10|NCV 10 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
770741|NCT01513148|O13|Outcome|Sham NCV Time 8|NCV 8 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
770742|NCT01513148|O12|Outcome|Sham NCV Time 6|NCV 6 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
770743|NCT01513148|O11|Outcome|Sham NCV Time 4|NCV 4 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
770744|NCT01513148|O10|Outcome|Sham NCV Time 2|NCV 2 minutes following the application of sham superluminous diodes light irradiation over the superficial radial nerve
770745|NCT01513148|O9|Outcome|Sham NCV Time 0|NCV immediately (Time 0) following the application of superluminous diodes light irradiation over the superficial radial nerve
770746|NCT01513148|O8|Outcome|Sham NCV Pretreatment|NCV at baseline, before the application of sham superluminous diodes light irradiation over the superficial radial nerve
770747|NCT01513148|O7|Outcome|Light NCV Time 10|NCV 10 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
770748|NCT01513148|O6|Outcome|Light NCV Time 8|NCV 8 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
770749|NCT01513148|O5|Outcome|Light NCV Time 6|NCV 6 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
770750|NCT01513148|O4|Outcome|Light NCV Time 4|NCV 4 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
770751|NCT01513148|O3|Outcome|Light NCV Time 2|NCV 2 minutes following the application of super luminous diodes light irradiation over the superficial radial nerve
770752|NCT01513148|O2|Outcome|Light NCV Time 0|NCV at time 0, immediately following the application of super luminous diodes light irradiation over the superficial radial nerve
791992|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
770753|NCT01513148|O1|Outcome|Light NCV Pretreatment|NCV at baseline, before the application of super luminous diodes light irradiation over the superficial radial nerve
770754|NCT01513148|E2|Reported Event|Sham Irradiation|Sham Irradiation over the Superficial Radial Nerve for the same time period as the intervention group
770755|NCT01513148|E1|Reported Event|Light Therapy|Application of super luminous diodes light irradiation over the superficial radial nerve
770756|NCT01513122|B3|Baseline|Total|Total of all reporting groups
770757|NCT01513122|B2|Baseline|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770758|NCT01513122|B1|Baseline|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770759|NCT01513122|P2|Participant Flow|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770760|NCT01513122|P1|Participant Flow|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770761|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770762|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770813|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
770763|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770764|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770765|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770766|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770767|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770768|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770769|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770770|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770771|NCT01513122|O2|Outcome|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770772|NCT01513122|O1|Outcome|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770773|NCT01513122|E2|Reported Event|Arm 2. Lopinavir /Ritonavir + Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily.
770774|NCT01513122|E1|Reported Event|Arm 1. Lopinavir / Ritonavir + 2-3N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
770775|NCT01512979|B3|Baseline|Total|Total of all reporting groups
770776|NCT01512979|B2|Baseline|Linagliptin 5mg|Patients treated with linagliptin 5mg
770777|NCT01512979|B1|Baseline|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770778|NCT01512979|P2|Participant Flow|Linagliptin 5mg|Patients treated with linagliptin 5mg
770779|NCT01512979|P1|Participant Flow|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770780|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
770781|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770782|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
770783|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770784|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
770785|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770786|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
770787|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770788|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
770789|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770790|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
770791|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770792|NCT01512979|O2|Outcome|Linagliptin 5mg|Patients treated with linagliptin 5mg
770793|NCT01512979|O1|Outcome|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770794|NCT01512979|E2|Reported Event|Linagliptin 5mg|Patients treated with linagliptin 5mg
770795|NCT01512979|E1|Reported Event|Linagliptin 5mg + Metformin|Patients treated with linagliptin 5mg and metformin IR (1500mg to 2000mg total daily dose)
770796|NCT01512849|B3|Baseline|Total|Total of all reporting groups
770797|NCT01512849|B2|Baseline|Entire Population for Normal Renal Function|
770798|NCT01512849|B1|Baseline|Entire Population for Moderate Renal Impairment|
770799|NCT01512849|P4|Participant Flow|Normal Renal Function High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
770800|NCT01512849|P3|Participant Flow|Normal Renal Function Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
770801|NCT01512849|P2|Participant Flow|Moderate Renal Impairment High Dose First|TA-7284 High dose in Period 1, then crossover to TA-7284 Low dose in Period 2
770802|NCT01512849|P1|Participant Flow|Moderate Renal Impairment Low Dose First|TA-7284 Low dose in Period 1, then crossover to TA-7284 High dose in Period 2
770803|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
770804|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
770805|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
770806|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
770807|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
770808|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
770809|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
770810|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
770811|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
770812|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
770815|NCT01512849|O4|Outcome|Normal Renal Function High|TA-7284-High was administered in a single dose.
770816|NCT01512849|O3|Outcome|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
770817|NCT01512849|O2|Outcome|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
770818|NCT01512849|O1|Outcome|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
770819|NCT01512849|E4|Reported Event|Normal Renal Function High|TA-7284-High was administered in a single dose.
770820|NCT01512849|E3|Reported Event|Normal Renal Function Low|TA-7284-Low was administered in a single dose.
770821|NCT01512849|E2|Reported Event|Moderate Renal Impairment High|TA-7284-High was administered in a single dose.
770822|NCT01512849|E1|Reported Event|Moderate Renal Impairment Low|TA-7284-Low was administered in a single dose.
770823|NCT01512745|B3|Baseline|Total|Total of all reporting groups
770824|NCT01512745|B2|Baseline|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770825|NCT01512745|B1|Baseline|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770826|NCT01512745|P2|Participant Flow|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770827|NCT01512745|P1|Participant Flow|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770828|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770829|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770830|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770831|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770832|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770833|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770834|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770835|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770836|NCT01512745|O2|Outcome|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770837|NCT01512745|O1|Outcome|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770838|NCT01512745|E2|Reported Event|Placebo|placebo: placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770839|NCT01512745|E1|Reported Event|Apatinib|apatinib: apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
770840|NCT01512368|B1|Baseline|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770841|NCT01512368|P1|Participant Flow|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770842|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770843|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770844|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770845|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770846|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770847|NCT01512368|O1|Outcome|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770848|NCT01512368|E1|Reported Event|Supervised Exercising|A treadmill exercise test (following the Bruce’s protocol) was done five times per week (from Monday to Friday) for two weeks to participants.
770849|NCT01512225|B3|Baseline|Total|Total of all reporting groups
770850|NCT01512225|B2|Baseline|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770851|NCT01512225|B1|Baseline|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770852|NCT01512225|P2|Participant Flow|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770853|NCT01512225|P1|Participant Flow|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770854|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770855|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770856|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770857|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770858|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770859|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770860|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770861|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770862|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770863|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770864|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770865|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770866|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770867|NCT01512225|O1|Outcome|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770868|NCT01512225|O2|Outcome|Group B: Placebo + Domperidone|Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days
770869|NCT01512225|O1|Outcome|Group A: Domperidone|Domperidone 10 mg orally three times daily for 28 days
770870|NCT01512225|E2|Reported Event|Group B: Placebo + Domperidone|"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days~Domperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days"
770871|NCT01512225|E1|Reported Event|Group A: Domperidone|"Domperidone 10 mg orally three times daily for 28 days~Domperidone maleate: domperidone 10 mg orally three times daily for 28 days"
770872|NCT01512160|B5|Baseline|Total|Total of all reporting groups
770873|NCT01512160|B4|Baseline|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770874|NCT01512160|B3|Baseline|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
771092|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
770875|NCT01512160|B2|Baseline|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770876|NCT01512160|B1|Baseline|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770877|NCT01512160|P4|Participant Flow|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770878|NCT01512160|P3|Participant Flow|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770879|NCT01512160|P2|Participant Flow|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
771007|NCT01511809|B2|Baseline|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
770880|NCT01512160|P1|Participant Flow|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 milligram (mg) spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 millimeter (mm) on a 100 mm Visual Analogue Scale (VAS).
770881|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770882|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770883|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770884|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770885|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770886|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770887|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770888|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770889|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770890|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770891|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770892|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770893|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770894|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770895|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770896|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770897|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770898|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
816604|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
770899|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770900|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770901|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770902|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770903|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770904|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770905|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770906|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770907|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770908|NCT01512160|O1|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770909|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770910|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770911|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770912|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
771193|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
770913|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770914|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770915|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770916|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
771008|NCT01511809|B1|Baseline|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
816605|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
770917|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770918|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770919|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770920|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770921|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770922|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770923|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770924|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770925|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770926|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770927|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770928|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770929|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770930|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770931|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
771194|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
770932|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770933|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770934|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770935|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770936|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770937|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770938|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770939|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770940|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770941|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770942|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770943|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770944|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770945|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770946|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770947|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770948|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770949|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770950|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
771979|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
770951|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770952|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770953|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770954|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770955|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770956|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770957|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770958|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770959|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770960|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770961|NCT01512160|O4|Outcome|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770962|NCT01512160|O3|Outcome|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770963|NCT01512160|O2|Outcome|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770964|NCT01512160|O1|Outcome|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770965|NCT01512160|E4|Reported Event|Placebo|Single oral dose of placebo matched to PF-04531083 spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770966|NCT01512160|E3|Reported Event|Ibuprofen 400 mg|Single oral dose of 2 ibuprofen 200 mg tablets (equivalent to ibuprofen 400 mg) along with placebo matched to PF-04531083 spray dried dispersion presented as an oral solution 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770967|NCT01512160|E2|Reported Event|PF-04531083 2000 mg|Single oral dose of PF-04531083 2000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770968|NCT01512160|E1|Reported Event|PF-04531083 1000 mg|Single oral dose of PF-04531083 1000 mg spray dried dispersion presented as an oral solution along with 2 placebo tablets matched to ibuprofen 200 mg (equivalent to ibuprofen 400 mg) 1 to 5 hours post-surgery in participants with post-surgical pain intensity of moderate to severe, and confirmed by a score of at least 50 mm on a 100 mm VAS.
770969|NCT01512108|B3|Baseline|Total|Total of all reporting groups
770970|NCT01512108|B2|Baseline|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
771980|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
770971|NCT01512108|B1|Baseline|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
770972|NCT01512108|P2|Participant Flow|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
770973|NCT01512108|P1|Participant Flow|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
770974|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
771009|NCT01511809|P2|Participant Flow|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
770975|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
770976|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
770977|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
770978|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
770979|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
770980|NCT01512108|O2|Outcome|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
770981|NCT01512108|O1|Outcome|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
770982|NCT01512108|E2|Reported Event|Additional OAD|Subject's received additional OAD to pre-trial OAD. The type and dosage of additional OAD was chosen based on each individual’s glycaemic control by the investigator as per Japanese labelling.
770983|NCT01512108|E1|Reported Event|Liraglutide 0.9 mg/Day|Liraglutide 0.9 mg/day was injected subcutaneously, once daily in morning or evening in addition to unchanged pre-trial oral anti-diabetic drug (OAD) (either glinide, metformin, α-glucosidase inhibitor or thiazolidinedione) for 52 weeks. Liraglutide was started at 0.3 mg/day and dose was escalated to maximum dose level of 0.9 mg/day by weekly increment of 0.3 mg.
770984|NCT01511939|B4|Baseline|Total|Total of all reporting groups
770985|NCT01511939|B3|Baseline|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770986|NCT01511939|B2|Baseline|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770987|NCT01511939|B1|Baseline|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770988|NCT01511939|P3|Participant Flow|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770989|NCT01511939|P2|Participant Flow|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771053|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
770990|NCT01511939|P1|Participant Flow|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis (OA) pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770991|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771010|NCT01511809|P1|Participant Flow|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
770992|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770993|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770994|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770995|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770996|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770997|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770998|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
770999|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771000|NCT01511939|O3|Outcome|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771001|NCT01511939|O2|Outcome|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771002|NCT01511939|O1|Outcome|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771003|NCT01511939|E3|Reported Event|Pennsaid, Aspirin and/or Clopidogrel|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of aspirin and/or clopidogrel for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771088|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771004|NCT01511939|E2|Reported Event|Pennsaid, Dabigatran|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of dabigatran for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771005|NCT01511939|E1|Reported Event|Pennsaid, Warfarin|"Pennsaid 1.5%, 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period in a subject who has been taking a stable dose of warfarin for at least 2 months~Pennsaid: Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if OA pain is present bilaterally) 4 times a day for a 4 week active treatment period."
771006|NCT01511809|B3|Baseline|Total|Total of all reporting groups
771011|NCT01511809|O2|Outcome|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
771012|NCT01511809|O1|Outcome|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
771013|NCT01511809|E2|Reported Event|Atazanavir/Ritonavir Triple Therapy|Patients will continue the same regimen ATV/RTV 300mg/100mg OD plus 2 NRTIs as backbone
771014|NCT01511809|E1|Reported Event|Atazanavir/Ritonavir Monotherapy|"Patients will simplify therapy to ATV/RTV 300mg/100mg OD as monotherapy~Atazanavir/ritonavir monotherapy: Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks."
771015|NCT01511536|B4|Baseline|Total|Total of all reporting groups
771016|NCT01511536|B3|Baseline|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771017|NCT01511536|B2|Baseline|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771018|NCT01511536|B1|Baseline|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771019|NCT01511536|P3|Participant Flow|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at maximum tolerated dose (MTD) as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771020|NCT01511536|P2|Participant Flow|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771021|NCT01511536|P1|Participant Flow|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771022|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771023|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771024|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771025|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771026|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771027|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771089|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771028|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771029|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/ m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771030|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771031|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771032|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771060|NCT01511315|E1|Reported Event|Ustekinumab|Ustekinumab: Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
771061|NCT01511107|B3|Baseline|Total|Total of all reporting groups
771033|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771034|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771035|NCT01511536|O1|Outcome|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771036|NCT01511536|O1|Outcome|Phase 1: Overall Population|Cabazitaxel 20 or 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771037|NCT01511536|E3|Reported Event|Phase 2: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel at MTD as determined in phase 1 part (25 mg/m^2) IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771038|NCT01511536|E2|Reported Event|Phase 1: Cabazitaxel 25 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771039|NCT01511536|E1|Reported Event|Phase 1: Cabazitaxel 20 mg/m^2 + Abiraterone 1000 mg|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with abiraterone acetate 1000 mg orally once daily and prednisone 5 mg orally twice daily until disease progression, unacceptable toxicity or consent withdrawal.
771040|NCT01511445|B3|Baseline|Total|Total of all reporting groups
771041|NCT01511445|B2|Baseline|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
771042|NCT01511445|B1|Baseline|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
771043|NCT01511445|P2|Participant Flow|ACDF With PEEK Interbody Cage|"Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic. The open space in the center of the cage is to be filled with local autologous bone harvested during the decompression phase of the procedure.~Anterior cervical discectomy and fusion (ACDF) with PEEK Cage: Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer"
771044|NCT01511445|P1|Participant Flow|ACDF With Valeo CSC Ceramic Cage|"ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage. The center area of the cage is filled with porous silicon nitride. No autologous bone is used; the cage is soaked in patient blood.~Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage: Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer."
771045|NCT01511445|O2|Outcome|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
771046|NCT01511445|O1|Outcome|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
771047|NCT01511445|O2|Outcome|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
771048|NCT01511445|O1|Outcome|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
771049|NCT01511445|E2|Reported Event|ACDF With PEEK Interbody Cage|Anterior cervical discectomy and fusion (ACDF) with an interbody spacer made from polyetheretherketone (PEEK) plastic.
771050|NCT01511445|E1|Reported Event|ACDF With Valeo CSC Ceramic Cage|ACDF with the Valeo CSC cage, a silicon nitride ceramic interbody cage.
771051|NCT01511315|B1|Baseline|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771052|NCT01511315|P1|Participant Flow|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771090|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771054|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771055|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771056|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771057|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771058|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771059|NCT01511315|O1|Outcome|Ustekinumab|Biologic agent: ustekinumab 45mg pre-filled syringes, subcutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter. (each dose of 45mg for subjects weighing less than or equal to 100kg and 90mg for subjects weighing greater than 100kg)
771062|NCT01511107|B2|Baseline|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771063|NCT01511107|B1|Baseline|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771064|NCT01511107|P2|Participant Flow|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771065|NCT01511107|P1|Participant Flow|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771066|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771067|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771068|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771069|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771070|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771071|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771072|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771073|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771074|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771075|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771076|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771077|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771078|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771079|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771080|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771081|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771082|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771083|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771084|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771085|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771086|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771087|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771091|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771093|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771094|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771095|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771096|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771097|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771098|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771099|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771100|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771101|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771102|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771103|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771104|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771105|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771106|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771107|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771108|NCT01511107|O2|Outcome|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771109|NCT01511107|O1|Outcome|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771110|NCT01511107|E2|Reported Event|Amoxicillin-Clavulanate, 5 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for Days 1-5 followed by placebo in 2 divided doses for Days 6-10.
771111|NCT01511107|E1|Reported Event|Amoxicillin-Clavulanate, 10 Days|Amoxicillin-clavulanate administered at a dosage of 90/6.4mg/kg/day in 2 divided doses for 10 days.
771112|NCT01511016|B3|Baseline|Total|Total of all reporting groups
771113|NCT01511016|B2|Baseline|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771114|NCT01511016|B1|Baseline|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771115|NCT01511016|P2|Participant Flow|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771116|NCT01511016|P1|Participant Flow|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771117|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771118|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771119|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771120|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771121|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771122|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771123|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771124|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771125|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771126|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771127|NCT01511016|O2|Outcome|Human Recombinant Leptin (Metreleptin)|"Each subject received 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771128|NCT01511016|O1|Outcome|Placebo Injection|"Each subject received placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771129|NCT01511016|E2|Reported Event|Human Recombinant Leptin (Metreleptin)|"Each subject will receive 0.02 mg leptin / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg leptin / kg for two more months.~Human recombinant leptin (metreleptin) : Metreleptin will be administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months."
771130|NCT01511016|E1|Reported Event|Placebo Injection|"Each subject will receive placebo at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by a dose of 0.04 mg / kg for two more months.~Placebo : Placebo will administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months."
771131|NCT01510912|B1|Baseline|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
771132|NCT01510912|P1|Participant Flow|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
771133|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
771134|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
771135|NCT01510912|O1|Outcome|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
771136|NCT01510912|E1|Reported Event|Diclofenac 35 mg Capsules|Participants were administered Diclofenac 35 mg capsules two times daily and could either be uptitrated to three times daily or remain at two times daily. Participants who were uptitrated to three times daily were allowed to downtitrate to two times daily either temporarily or permanently. Participants could change regimens between two and three times daily as often as needed, with the approval of the investigator.
771137|NCT01510834|B1|Baseline|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
771138|NCT01510834|P1|Participant Flow|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
771139|NCT01510834|O1|Outcome|Mean Difference in PHQ-8 (T1, T3)|Mean Difference in PHQ-8 (T1,T3) for study completers
771140|NCT01510834|O1|Outcome|Mean Difference in PSS (T1, T3)|Mean difference in Perceived Stress Scale (T1, T3) for study completers
771141|NCT01510834|O1|Outcome|Mean Difference in QOLS (T1, T3)|Mean Difference in QOLS (T1, T3)for study completers only
771981|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771142|NCT01510834|O1|Outcome|Mean Difference in PCL (T1, T3) (Negative Change is Better)|Mean difference in PCL (T1, T3) for study completers
771143|NCT01510834|E1|Reported Event|All Participants|All participants who met study criteria, consented and were enrolled, were asked to complete online assessments at three timepoints(baseline, 1-month, and 3-months) and complete 2 or more behavioral programs each month.
771144|NCT01510769|B4|Baseline|Total|Total of all reporting groups
771145|NCT01510769|B3|Baseline|Placebo + Febuxostat|
771146|NCT01510769|B2|Baseline|Lesinurad 400 mg + Febuxostat|
771147|NCT01510769|B1|Baseline|Lesinurad 200 mg + Febuxostat|
771148|NCT01510769|P3|Participant Flow|Placebo + Febuxostat|
771149|NCT01510769|P2|Participant Flow|Lesinurad 400 mg + Febuxostat|
771150|NCT01510769|P1|Participant Flow|Lesinurad 200 mg + Febuxostat|
771151|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
771152|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
771153|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
771154|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
771155|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
771156|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
771157|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
771215|NCT01510704|E1|Reported Event|Placebo|
771158|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
771159|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
771160|NCT01510769|O3|Outcome|Placebo + Febuxostat 80 mg|placebo qd plus febuxostat 80 mg
771161|NCT01510769|O2|Outcome|Lesinurad 400 mg + Febuxostat 80 mg|lesinurad 400 mg qd plus febuxostat 80 mg
771162|NCT01510769|O1|Outcome|Lesinurad 200 mg + Febuxostat 80 mg|lesinurad 200 mg once daily (qd) plus febuxostat 80 mg
771163|NCT01510769|E3|Reported Event|Placebo + Febuxostat|
771164|NCT01510769|E2|Reported Event|Lesinurad 400 mg + Febuxostat|
771165|NCT01510769|E1|Reported Event|Lesinurad 200 mg + Febuxostat|
771166|NCT01510756|B1|Baseline|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
771167|NCT01510756|P1|Participant Flow|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
771168|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
771169|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
771170|NCT01510756|O1|Outcome|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
771171|NCT01510756|E1|Reported Event|Sorafenib|"Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days).~Sorafenib: Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles."
771172|NCT01510717|B3|Baseline|Total|Total of all reporting groups
771173|NCT01510717|B2|Baseline|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771174|NCT01510717|B1|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771175|NCT01510717|P2|Participant Flow|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771176|NCT01510717|P1|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771177|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771178|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771179|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771180|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771181|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771182|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771183|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771184|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771185|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771186|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771187|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771188|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771189|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771190|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771191|NCT01510717|O2|Outcome|Monofocal IOL|AcrySof® IQ Monofocal IOL Model SN60WF
771192|NCT01510717|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771196|NCT01510717|E3|Reported Event|Monofocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ Monofocal IOL Model SN60WF
771197|NCT01510717|E2|Reported Event|Multifocal IOL|All participants with attempted IOL implantation in at least one eye (successful or aborted after contact with the eye), AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]
771198|NCT01510717|E1|Reported Event|Pre-Treatment|All enrolled participants
771199|NCT01510704|B5|Baseline|Total|Total of all reporting groups
771200|NCT01510704|B4|Baseline|High Dose APD421|20mg dose level
771201|NCT01510704|B3|Baseline|Mid Dose APD421|5mg dose level
771202|NCT01510704|B2|Baseline|Low Dose APD421|1mg dose level
771203|NCT01510704|B1|Baseline|Placebo|
771204|NCT01510704|P4|Participant Flow|High Dose APD421|20mg dose level
771205|NCT01510704|P3|Participant Flow|Mid Dose APD421|5mg dose level
771206|NCT01510704|P2|Participant Flow|Low Dose APD421|1mg dose level
771207|NCT01510704|P1|Participant Flow|Placebo|
771208|NCT01510704|O4|Outcome|High Dose APD421|20mg dose level
771209|NCT01510704|O3|Outcome|Mid Dose APD421|5mg dose level
771210|NCT01510704|O2|Outcome|Low Dose APD421|1mg dose level
771211|NCT01510704|O1|Outcome|Placebo|
771212|NCT01510704|E4|Reported Event|High Dose APD421|20mg dose level
771213|NCT01510704|E3|Reported Event|Mid Dose APD421|5mg dose level
771214|NCT01510704|E2|Reported Event|Low Dose APD421|1mg dose level
771217|NCT01510652|B2|Baseline|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
771218|NCT01510652|B1|Baseline|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
771219|NCT01510652|P2|Participant Flow|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
771220|NCT01510652|P1|Participant Flow|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
771221|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
771222|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
771223|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
771224|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
771225|NCT01510652|O2|Outcome|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
771226|NCT01510652|O1|Outcome|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
771227|NCT01510652|E2|Reported Event|BiP Group|"Patients in the BiP Group will be implanted with a standard (regulatory approved and commercially available) bipolar left ventricular lead from other companies (non St. Jude Medical leads)~Standard Left Ventricular (LV) lead: Implantation of standard Left Ventricular (LV) lead"
771228|NCT01510652|E1|Reported Event|Quad Group|"Patients in the Quad group will be implanted with St. Jude Medical (SJM) quadripolar Left Ventricular (LV) lead Quartet~Quartet Left Ventricular (LV) lead: Implantation of quadripolar Left ventricular (LV) lead Quartet"
771229|NCT01510457|B3|Baseline|Total|Total of all reporting groups
771230|NCT01510457|B2|Baseline|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771231|NCT01510457|B1|Baseline|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771232|NCT01510457|P2|Participant Flow|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771233|NCT01510457|P1|Participant Flow|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
791993|NCT01433263|O1|Outcome|30mg/kg BYM338|
771234|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771235|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771236|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771237|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771238|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771262|NCT01510327|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771239|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771240|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771241|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771242|NCT01510457|O2|Outcome|Milnacipran|"Uptitration from 10mg to 50mg BID Milnacipran~Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used."
771243|NCT01510457|O1|Outcome|Sugar Pill|"BID placebo~Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication."
771244|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771245|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771246|NCT01510457|O2|Outcome|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771247|NCT01510457|O1|Outcome|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771248|NCT01510457|E2|Reported Event|Sugar Pill|Placebo: Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
771249|NCT01510457|E1|Reported Event|Milnacipran|Milnacipran: Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
771250|NCT01510379|B3|Baseline|Total|Total of all reporting groups
771251|NCT01510379|B2|Baseline|Control|Scheduled ondansetron plus phenergan prn
771252|NCT01510379|B1|Baseline|Reletex|Reletex plus scheduled ondansetron and phenergan prn
771253|NCT01510379|P2|Participant Flow|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
771385|NCT01509625|O2|Outcome|Previous Treatment With Two or More Hormonal Treatment Lines|The patients have received at least two hormonal treatment: tamoxifen and aromatase inhibitor
771254|NCT01510379|P1|Participant Flow|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
771255|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
771256|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
771257|NCT01510379|O2|Outcome|Control|Scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
771258|NCT01510379|O1|Outcome|Reletex|Reletex plus scheduled IV ondansetron 4 mg q 6 hours for a total of 4 doses. Breakthrough nausea will be treated using IV promethazine 25 mg q 6 hours prn during the hospital stay and in elixir at the same dose and frequency after discharge.
771259|NCT01510379|E2|Reported Event|Control|Scheduled ondansetron plus phenergan prn
771260|NCT01510379|E1|Reported Event|Reletex|Reletex plus scheduled ondansetron and phenergan prn
771261|NCT01510327|B1|Baseline|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771263|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771264|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771265|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771266|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771267|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771268|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771269|NCT01510327|O1|Outcome|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771270|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771271|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771272|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771273|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771274|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771275|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771276|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771277|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771278|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771279|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771280|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771281|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771282|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771386|NCT01509625|O1|Outcome|Previous Treatment Wiht One Line of Hormonal Treatment|Hormonal treatment was tamoxifen or an aromatase inhibitor
771283|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771284|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771285|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771286|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771287|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; the dose of everolimus is based on the number and sizes of stents implanted
771288|NCT01510327|O3|Outcome|Everolimus Dose of 138.6 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
771289|NCT01510327|O2|Outcome|Everolimus Dose of 102.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents.
771290|NCT01510327|O1|Outcome|Everolimus Dose of 95.4 µg|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique; total dose of everolimus administered is based on the number of stents received and the size of the stents
771291|NCT01510327|E1|Reported Event|PROMUS Element|Patients who received the PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
771292|NCT01510158|B4|Baseline|Total|Total of all reporting groups
771293|NCT01510158|B3|Baseline|Placebo + Allopurinol|placebo qd plus allopurinol
771294|NCT01510158|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
771295|NCT01510158|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
771296|NCT01510158|P3|Participant Flow|Placebo + Allopurinol|placebo qd plus allopurinol
771297|NCT01510158|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
771298|NCT01510158|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
771299|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
771300|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
771301|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
771302|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
771303|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
771304|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
771305|NCT01510158|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
771306|NCT01510158|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
771307|NCT01510158|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
771308|NCT01510158|E3|Reported Event|Placebo + Allopurinol|placebo qd plus allopurinol
771309|NCT01510158|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
771310|NCT01510158|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
771311|NCT01510145|B1|Baseline|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
771312|NCT01510145|P1|Participant Flow|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
771313|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
771314|NCT01510145|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
771315|NCT01510145|E1|Reported Event|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks.
771316|NCT01509807|B3|Baseline|Total|Total of all reporting groups
771317|NCT01509807|B2|Baseline|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771318|NCT01509807|B1|Baseline|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771319|NCT01509807|P2|Participant Flow|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771320|NCT01509807|P1|Participant Flow|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
791994|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
771321|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771322|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771323|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771324|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771343|NCT01509664|B3|Baseline|Total|Total of all reporting groups
771344|NCT01509664|B2|Baseline|Control|Received no discount at the participating supermarket.
771345|NCT01509664|B1|Baseline|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
771325|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771326|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771327|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771328|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771329|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771330|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771331|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771332|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771333|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771334|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771335|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771336|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771337|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771338|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771387|NCT01509625|O2|Outcome|Patients With Visceral Metastasis|Group of patients with metastasis in organs like liver or lungs
771339|NCT01509807|O2|Outcome|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771340|NCT01509807|O1|Outcome|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771341|NCT01509807|E2|Reported Event|Group 2|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL: Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771342|NCT01509807|E1|Reported Event|Group 1|"IV morphine sulfate (or Sponsor-approved equivalent), Standard of Care (SOC)~IV morphine sulfate or Sponsor-approved equivalent: Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed."
771346|NCT01509664|P2|Participant Flow|Control|Received no discount at the participating supermarket.
771347|NCT01509664|P1|Participant Flow|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
771348|NCT01509664|O2|Outcome|Control|Received no discount at the participating supermarket.
771349|NCT01509664|O1|Outcome|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
771350|NCT01509664|E2|Reported Event|Control|Received no discount at the participating supermarket.
771351|NCT01509664|E1|Reported Event|Discount Intervention|"Receives 50% discount intervention on selected fruits and vegetables at participating supermarket.~Discount intervention: 50% discount on selected fruits and vegetables at participating supermarket"
771352|NCT01509638|B3|Baseline|Total|Total of all reporting groups
771353|NCT01509638|B2|Baseline|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771354|NCT01509638|B1|Baseline|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771355|NCT01509638|P2|Participant Flow|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771356|NCT01509638|P1|Participant Flow|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771357|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771358|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771359|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771360|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771361|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771362|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771388|NCT01509625|O1|Outcome|Patients Without Visceral Metastasis|Group of patients without metastasis in organs like liver or lungs
771363|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771364|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771365|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771366|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771367|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
816606|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
771368|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771369|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771370|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771371|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771372|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771373|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771374|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771375|NCT01509638|O2|Outcome|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771376|NCT01509638|O1|Outcome|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771377|NCT01509638|E2|Reported Event|Group 2 EXPAREL|"bupivacaine liposome injectable suspension.~Group 2 EXPAREL: Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care."
771378|NCT01509638|E1|Reported Event|Group 1 Standard of Care|"IV Morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump~Group 1 Standard of Care: Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed."
771379|NCT01509625|B1|Baseline|One Arm of Metastatic RE Breast Cancer Patients|Women with metastatic breast cancer who have disease progresion after prior antiestrogen treatment. All tumors were positive estrogen receptors
771380|NCT01509625|P1|Participant Flow|One Arm of Metastatic Breast Cancer Patients|All the patients have tumors with positive estrogen receptors
771381|NCT01509625|O2|Outcome|Patients With Tumors ki67 Negative|Patients with tumors with low ki67 expression
771382|NCT01509625|O1|Outcome|Patients With Tumors ki67 Positive|Patients with tumors with high ki67 expression
771383|NCT01509625|O2|Outcome|Patients With Tumors HER2 Negative|tumor is considered HER2 negative if there is not a sobreexpression of the receptor by immunohistochemistry or FISH is positive
771384|NCT01509625|O1|Outcome|Patients With Tumors HER2 Positive|tumor is considered HER2 positive if there is a sobreexpression of the receptor by immunohistochemistry or FISH is positive
771982|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771390|NCT01509625|O1|Outcome|Patients With Clinical Benefit|Patients wich achieved a clinical benefit with fulvetrant 500: complete response, partial response or stable disease of 24 weeks or longer
771391|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
771392|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
771393|NCT01509625|O1|Outcome|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
771394|NCT01509625|E1|Reported Event|One Arm of Metastatic Breast Cancer Patients|All patients have tumors with positive estrogen receptors
771395|NCT01509586|B3|Baseline|Total|Total of all reporting groups
771396|NCT01509586|B2|Baseline|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
771397|NCT01509586|B1|Baseline|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
771398|NCT01509586|P2|Participant Flow|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
772498|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
771399|NCT01509586|P1|Participant Flow|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
771400|NCT01509586|O2|Outcome|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
771401|NCT01509586|O1|Outcome|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
771402|NCT01509586|E2|Reported Event|Cigarette Group|This group will smoke their normal cigarettes as much or as little as they want to.
771403|NCT01509586|E1|Reported Event|PREP (Potentially Reduced Exposure Product) Group|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product: The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
771404|NCT01509105|B1|Baseline|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771405|NCT01509105|P1|Participant Flow|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771406|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771521|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771522|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771523|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771524|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
791995|NCT01433263|O1|Outcome|30mg/kg BYM338|
771407|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771408|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771548|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
771553|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
771409|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771410|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771411|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771412|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771413|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771414|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771415|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771525|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771526|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771527|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771416|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771417|NCT01509105|O1|Outcome|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771418|NCT01509105|E1|Reported Event|Prevenar 13|Participants aged below 6 months recieved single 0.5 milliliter (mL) dose of Prevenar 13 vaccine, intramuscularly at approximately 2, 4, 6 months of age and single 0.5 mL booster dose at least 60 days after the last dose. Participants aged between 7 to 11 months recieved 2 doses of 0.5 mL Prevenar 13 vaccine intramuscularly, at least 1 month apart and one 0.5 mL dose after the age of 12 months, separated from the previous dose by at least 2 months. Participants aged between 12 to 23 months recieved two 0.5 mL doses of Prevenar 13 vaccine intramuscularly, at least 2 months apart. Participants aged between 24 months to 17 years recieved single 0.5 mL dose of Prevenar 13 vaccine intramuscularly. Participants were followed up to 28 days after last dose of study vaccination.
771419|NCT01509079|B3|Baseline|Total|Total of all reporting groups
771420|NCT01509079|B2|Baseline|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771421|NCT01509079|B1|Baseline|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771422|NCT01509079|P2|Participant Flow|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771423|NCT01509079|P1|Participant Flow|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771424|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771425|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771426|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771427|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771428|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771429|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771430|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771431|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771432|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771433|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771434|NCT01509079|O2|Outcome|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771435|NCT01509079|O1|Outcome|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771436|NCT01509079|E2|Reported Event|Vitamin D3 600 IU|Vitamin D3: cholecalciferol capsule, 600 IU, daily for 6 months
771437|NCT01509079|E1|Reported Event|Vitamin D3 4000 IU|Vitamin D3: Cholecalciferol capsule, 4000IU, daily for 6 months
771438|NCT01509053|B1|Baseline|All Participants|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
771439|NCT01509053|P1|Participant Flow|Oral Aripiprazole Tablets and Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
771440|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
771528|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771529|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771441|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
771442|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
771552|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
771443|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
771444|NCT01509053|O2|Outcome|Standard of Care|Patients who received oral antipsychotic treatment as standard of care in clinical practice.
771445|NCT01509053|O1|Outcome|Aripiprazole IM Depot Injection|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
771446|NCT01509053|E3|Reported Event|Aripiprazole IM Depot (Phase C)|Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase (C). Oral aripiprazole was available as rescue medication if necessary.
771447|NCT01509053|E2|Reported Event|Aripiprazole IM Depot (Phase B)|In the Open-label Aripiprazole IM Depot Phase (B), participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Oral aripiprazole was available as rescue medication if necessary.
771448|NCT01509053|E1|Reported Event|Oral Aripiprazole (Phase A)|Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase (A) prior to receiving treatment with aripiprazole IM Depot.
771449|NCT01509040|B4|Baseline|Total|Total of all reporting groups
771450|NCT01509040|B3|Baseline|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
771451|NCT01509040|B2|Baseline|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
771452|NCT01509040|B1|Baseline|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771530|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771531|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771532|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771533|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771534|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771453|NCT01509040|P3|Participant Flow|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
771549|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
771550|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
773228|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
771454|NCT01509040|P2|Participant Flow|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
771455|NCT01509040|P1|Participant Flow|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771456|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771457|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771458|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771459|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771460|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771535|NCT01508936|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771536|NCT01508936|E1|Reported Event|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771461|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771551|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis.
771462|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
771463|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
771464|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771465|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771466|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771467|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771468|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771537|NCT01508910|B4|Baseline|Total|Total of all reporting groups
771538|NCT01508910|B3|Baseline|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
771539|NCT01508910|B2|Baseline|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
771983|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771485|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771469|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771470|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771471|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
771472|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
771473|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771474|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771475|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771476|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771540|NCT01508910|B1|Baseline|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
771541|NCT01508910|P4|Participant Flow|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
771477|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771478|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771479|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771480|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771481|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771482|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771483|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771484|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771542|NCT01508910|P3|Participant Flow|Unblinded Standard of Care (SOC) Arm|No study-related procedures were performed.
771543|NCT01508910|P2|Participant Flow|Active Control Arm|Targeted intramyocardial delivery of placebo after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
771486|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 90 mL/kg/h.~HIgh Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771487|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK 4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone-based membrane) filters used throughout study. Hemofilter changed every 6h after initiation of HF, and as required."
771488|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mmHg; inotropes, vasopressors if mean arterial pressure is less than 65 mmHg; vasodilators, if mean arterial pressure is 90 mmHg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771489|NCT01509040|O3|Outcome|High Volume Hemofiltration|"Initiate standard post-resuscitative care including a triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core"
771490|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core tem"
771491|NCT01509040|O1|Outcome|Control|"Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious. Fluids, 500-mL bolus of intravenous crystalloid given every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Standard Care: Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.~Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.~Percutaneous coronary intervention performed as"
771492|NCT01509040|O3|Outcome|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
771589|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
771544|NCT01508910|P1|Participant Flow|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis.
771545|NCT01508910|O4|Outcome|Not Injected Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
771546|NCT01508910|O3|Outcome|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
771547|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
816607|NCT01339897|O4|Outcome|Placebo|Non-Active
771493|NCT01509040|O2|Outcome|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
771494|NCT01509040|O1|Outcome|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771495|NCT01509040|E3|Reported Event|High Volume Hemofiltration|"High volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/kg/h, ultrafiltration 90 mL/kg/h. .~High Volume Hemofiltration: Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
771496|NCT01509040|E2|Reported Event|Low Volume Hemofiltration|"Low Volume Hemofiltration: Initiate standard post-resuscitative care as in control group. Hemofiltration x 48 hours via 11.5F double lumen venous catheter, blood flow 250 mL/h, ultrafiltration 45 mL/kg/h.~Low Volume Hemofiltration: Patients will receive isovolemic HF. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
771497|NCT01509040|E1|Reported Event|Control|"Control group: Initiate standard post-resuscitative care including triple lumen catheter to monitor central venous pressure, core temperature maintenance between 32C and 34C if unconscious via standard external cooling techniques. Fluids, 500-mL bolus of intravenous crystalloid every 30 minutes to achieve a central venous pressure of 8 to 12 mm Hg; inotropes, vasopressors if mean arterial pressure is less than 65 mm Hg; vasodilators, if mean arterial pressure is 90 mm Hg or above to maintain hemodynamics.~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
771498|NCT01508936|B3|Baseline|Total|Total of all reporting groups
771499|NCT01508936|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771500|NCT01508936|B1|Baseline|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771501|NCT01508936|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771502|NCT01508936|P1|Participant Flow|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771503|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771504|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771505|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771506|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771507|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771508|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771509|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771510|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771511|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771512|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771513|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771514|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771515|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771516|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771517|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771518|NCT01508936|O1|Outcome|Placebo|Placebo intravenous injection every 4 weeks for a total of 4 doses.
771519|NCT01508936|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab intravenous injection at a dosage of 3.0 mg/kg every 4 weeks for a total of 4 doses.
771554|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
771555|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
771556|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
771557|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
771558|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
771559|NCT01508910|O2|Outcome|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
771560|NCT01508910|O1|Outcome|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
771561|NCT01508910|E4|Reported Event|Not Treated Arm|Participants randomized into the Treatment Arm or Active Control Arm who did not undergo targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells or placebo, respectively.
771562|NCT01508910|E3|Reported Event|Unblinded Standard of Care (SOC) Arm|No study-related procedures will be performed.
771563|NCT01508910|E2|Reported Event|Active Control Arm|Targeted intramyocardial delivery of placebo after G-CSF mobilization and apheresis
771564|NCT01508910|E1|Reported Event|Treatment Arm|Targeted intramyocardial delivery of 1 x 10^5 Auto-CD34+ cells after granulocyte-colony stimulating factor (G-CSF) mobilization and apheresis
771565|NCT01508832|B3|Baseline|Total|Total of all reporting groups
771566|NCT01508832|B2|Baseline|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% Digital Block (2cc), left finger; Bupivacaine 0.25% Digital Block (2 cc), right finger.
771567|NCT01508832|B1|Baseline|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% Digital Nerve Block (2 cc) , right finger. Bupivacaine 0.25% Digital Nerve Block (2 cc), left finger
771568|NCT01508832|P2|Participant Flow|Lidocaine Block, Left Finger; Bupivacaine Block, Right Finger|Lidocaine 1% digital nerve block (2cc), left finger; Bupivacaine 0.25% digital nerve block (2cc), right finger.
771569|NCT01508832|P1|Participant Flow|Lidocaine Block, Right Finger; Bupivacaine Block, Left Finger|Lidocaine 1% digital nerve block (2cc), right finger; Bupivacaine 0.25% digital nerve block (2cc), left finger.
771570|NCT01508832|O2|Outcome|Bupivacaine|Bupivacaine 0.25% digital nerve block (2cc) in one finger
771571|NCT01508832|O1|Outcome|Lidocaine|Lidocaine 1% digital nerve block (2cc) in one finger
771572|NCT01508832|E2|Reported Event|Bupivacaine|Bupivacaine digital block right or left finger
771573|NCT01508832|E1|Reported Event|Lidocaine|Lidocaine digital block in right or left finger
771574|NCT01508702|B3|Baseline|Total|Total of all reporting groups
771575|NCT01508702|B2|Baseline|Placebo|
771576|NCT01508702|B1|Baseline|Lesinurad 400 mg|lesinurad 400 mg
771577|NCT01508702|P2|Participant Flow|Placebo|
771578|NCT01508702|P1|Participant Flow|Lesinurad 400 mg|lesinurad 400 mg
771579|NCT01508702|O2|Outcome|Placebo|Placebo qd
771580|NCT01508702|O1|Outcome|Lesinurad 400 mg|lesinurad 400 mg
771581|NCT01508702|E2|Reported Event|Placebo|
771582|NCT01508702|E1|Reported Event|Lesinurad 400 mg|lesinurad 400 mg
771583|NCT01508676|B3|Baseline|Total|Total of all reporting groups
771584|NCT01508676|B2|Baseline|Placebo Phase I|Placebo lotion (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
771585|NCT01508676|B1|Baseline|Pennsaid Phase I|Pennsaid (20-40 drops; 2-4 times daily). Upon completion of the first phase, subjects in each arm will be crossed over (i.e., from placebo to Pennsaid and vise versa). Pennsaid or placebo lotion will be packed in a container with identical appearance before being dispensed to study subjects.
771586|NCT01508676|P2|Participant Flow|Placebo Phase I, Pennsaid Phase II|"Phase I: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily)."
771587|NCT01508676|P1|Participant Flow|Pennsaid Phase I, Placebo Phase II|"Phase I: 2 weeks applying Pennsaid lotion (20-40 drops; 2-4 times daily).~Washout: 1 week, applying nothing.~Phase II: 2 weeks applying Placebo lotion (20-40 drops; 2-4 times daily)."
771588|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
771984|NCT01507090|O3|Outcome|Mercy Method|Study coordinators performing measurements
771590|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Placebo lotion in either Phase I or II were considered.
771591|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
771592|NCT01508676|O2|Outcome|Placebo|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
771593|NCT01508676|O1|Outcome|Pennsaid|All subjects who recieved Pennsaid lotion in either Phase I or II were considered.
771594|NCT01508676|E2|Reported Event|Placebo|Placebo lotion (20-40 drops; 2-4 times daily for 2 weeks).
771595|NCT01508676|E1|Reported Event|Pennsaid|Pennsaid (20-40 drops; 2-4 times daily for 2 weeks).
771596|NCT01508455|B1|Baseline|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771597|NCT01508455|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771598|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771599|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771600|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
773229|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
771601|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771602|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771603|NCT01508455|O1|Outcome|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771604|NCT01508455|E1|Reported Event|Dexmedetomidine|Dexmedetomidine Load 0.2 mcg/kg over 10 or 20 min Dexmedetomidine Maintenance 0.2 mcg/kg/hr (at least 6 and up to 24 hours)
771605|NCT01508325|B3|Baseline|Total|Total of all reporting groups
771606|NCT01508325|B2|Baseline|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771607|NCT01508325|B1|Baseline|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771608|NCT01508325|P2|Participant Flow|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771609|NCT01508325|P1|Participant Flow|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.
771610|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771611|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771612|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771613|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771614|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771615|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771616|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771747|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771617|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771618|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771619|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771620|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
816608|NCT01339897|O3|Outcome|Cohort 3|N6022 - Active 20 mg
771621|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771622|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771623|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771624|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771625|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771626|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771627|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771628|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771629|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771630|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771631|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771632|NCT01508325|O2|Outcome|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771633|NCT01508325|O1|Outcome|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771634|NCT01508325|E2|Reported Event|Metoprolol|Subjects received metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol was escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771635|NCT01508325|E1|Reported Event|Bisoprolol|Subjects received bisoprolol fumarate (Concor®) at a dose of 5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of bisoprolol was escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic SBP was >= 140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
771636|NCT01508169|B3|Baseline|Total|Total of all reporting groups
771637|NCT01508169|B2|Baseline|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771649|NCT01508169|E2|Reported Event|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
816609|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
771638|NCT01508169|B1|Baseline|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771639|NCT01508169|P2|Participant Flow|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771640|NCT01508169|P1|Participant Flow|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771641|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771642|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771643|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771644|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771645|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771646|NCT01508169|O1|Outcome|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four patients finished the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771647|NCT01508169|O2|Outcome|Control Group|Forty-seven elderly women with osteoporosis (in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas- UNICAMP) were assigned, at random, to enter the control group with no foot intervention. Fourty-five subjects complited the protocolBalance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771780|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771648|NCT01508169|O1|Outcome|Foot Orthosis|Fourty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol. Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771670|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771650|NCT01508169|E1|Reported Event|Foot Orthosis|Forty-seven women in treatment in the outpatient clinic of the Rheumatology Division of State University of Campinas(UNICAMP) who met the inclusion criteria for this study (being female with osteoporosis and aged 60 or above) were assigned, at random, to wear ethyl-vinyl-acetate insoles with medial arch supports and metatarsal pads over a four-week period. Fourty-four subjects completed the protocol.Balance, using the Berg Balance Scale (BBS) and the Timed Up and Go (TUG) indexes; pain, using a numeric pain scale (NPS); and disability of the feet, using the Manchester Foot Pain and Disability Index (MFPDI), were assessed at baseline and after four weeks.
771651|NCT01508130|B3|Baseline|Total|Total of all reporting groups
771652|NCT01508130|B2|Baseline|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771653|NCT01508130|B1|Baseline|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771654|NCT01508130|P2|Participant Flow|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771655|NCT01508130|P1|Participant Flow|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received PegIFN + RBV + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771656|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771657|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771658|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771659|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771660|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771661|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771662|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771663|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771664|NCT01508130|O1|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771665|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771666|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771781|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771782|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771667|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771668|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771669|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771793|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
816610|NCT01339897|O1|Outcome|Cohort 1|N6022 - Active 5 mg
771671|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771672|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771673|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771674|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771675|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771676|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771677|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771678|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771679|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771680|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771681|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771682|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771683|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771684|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771685|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771686|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771687|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771783|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771985|NCT01507090|O2|Outcome|3D-TAPE|Study coordinators performing measurements
771688|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771689|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771690|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771691|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771692|NCT01508130|O2|Outcome|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771693|NCT01508130|O1|Outcome|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771694|NCT01508130|E2|Reported Event|PegIFN + RBV + BOC|As per the standard of care and U.S. labeling, participants received first 4 weeks of PegIFN + RBV (dual therapy), followed by additional 28 or 36 weeks of PegIFN + RBV + boceprevir (BOC) therapy, and/or then completed dual therapy through Week 48 depending on viral response and prior response status.
771695|NCT01508130|E1|Reported Event|PegIFN + RBV + TEL|As per the standard of care and U.S. labeling, participants received pegylated interferon alfa (PegIFN) + ribavirin (RBV) + telaprevir (TEL) for 12 weeks; followed by additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.
771696|NCT01508052|B3|Baseline|Total|Total of all reporting groups
771697|NCT01508052|B2|Baseline|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
771698|NCT01508052|B1|Baseline|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
771699|NCT01508052|P2|Participant Flow|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
771700|NCT01508052|P1|Participant Flow|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
771701|NCT01508052|O2|Outcome|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
771702|NCT01508052|O1|Outcome|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
771703|NCT01508052|E2|Reported Event|Elastic Stockings|"Apply elastic stockings during the thyroidectomy~sequential compression device: applying sequential compression device during the surgery"
771704|NCT01508052|E1|Reported Event|Sequential Compression Device|"Apply sequential compression device during the thyroidectomy~elastic stockings: applying elastic stockings during the surgery"
771705|NCT01508013|B3|Baseline|Total|Total of all reporting groups
771706|NCT01508013|B2|Baseline|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
771707|NCT01508013|B1|Baseline|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
771708|NCT01508013|P2|Participant Flow|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
771709|NCT01508013|P1|Participant Flow|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
771710|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
771711|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
771712|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
771713|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
771714|NCT01508013|O2|Outcome|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
791996|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
771715|NCT01508013|O1|Outcome|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
771716|NCT01508013|E2|Reported Event|Control Website|Control participants viewed an Internet site designed to provide drug and alcohol education for teens. Control Website: The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
771717|NCT01508013|E1|Reported Event|Appearance-Focused Website Intervention|This is a Internet-based appearance-focused prevention intervention based on the Behavioral Alternatives Model. Appearance-Focused Website Intervention: The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
771732|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771839|NCT01507493|B3|Baseline|Total|Total of all reporting groups
771718|NCT01507896|B1|Baseline|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
771719|NCT01507896|P1|Participant Flow|Treatment With BAX326|Recombinant Factor IX (FIX): Following a loading dose with BAX326, participants received BAX326 as a bolus infusion. The treatment regimen was determined by the intensity and duration of the hemostatic challenge and the institution's standard of care. The dose was tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries. Note: Treatment with BAX326 refers to unique participants treated with BAX326 which is less than the number of participants treated with BAX326 as unique participants could undergo more than one surgical procedure in this study. 30 unique participants were treated with BAX326 for 40 planned surgical procedures; of these, 2 unique participants were treated with BAX326 but did not undergo 2 surgical procedures (1 surgery per unique participant), therefore 28 unique participants underwent 38 surgical procedures.
771720|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771721|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
771722|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
771723|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
771724|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
771725|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
771726|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
771727|NCT01507896|O1|Outcome|Pre-surgical PK Assessment|A pre-surgical pharmacokinetic (PK) assessment was conducted for participants who had not undergone a PK assessment during the Pivotal study (Baxalta study 250901) before undergoing surgery in this study. Data is reported as pre-surgical PK assessment per surgical procedure as opposed to number of unique participants as a unique participant could have a pre-surgical PK assessment for more than one surgical procedure.
771728|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
771729|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
771784|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771730|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
771731|NCT01507896|O1|Outcome|Treatment With BAX326|All participants treated with BAX326 per planned surgical procedure and per unique participant. Data is reported as treatment with BAX326 per planned surgical procedure (including participants who discontinued in the study after treatment with BAX326 but before surgery was done) and per unique participants as a unique participant could be treated with BAX326 for more than one surgical procedure in this study.
776385|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
771733|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771734|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
771735|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth Minor surgeries.
771736|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771737|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
771738|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771739|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771740|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771741|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771742|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
771743|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771744|NCT01507896|O1|Outcome|All Surgical Procedures|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771745|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
771746|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771748|NCT01507896|O1|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient com fort. It generally referred to major orthopedic (e.g., joint replacement), major abdom inal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatom ical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771749|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions
771792|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771750|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771751|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771752|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
771753|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771754|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771755|NCT01507896|O3|Outcome|Minor Surgeries|Minor surgery defined as surgeries which could be safely and comfortably performed on a patient who had received local or topical anesthesia, without more than minimal pre-operative medication or minimal pre-operative medication or minimal intraoperative sedation. The likelihood of complications requiring hospitalization or prolonged hospitalization was remote. It referred to interventions such as removal of skin lesions, arthroscopy, minor dental procedures or dental extractions.
771756|NCT01507896|O2|Outcome|Major Surgeries|Major surgery defined as surgeries which required moderate or deep sedation, general anesthesia, or major conduction blockade for patient comfort. It generally referred to major orthopedic (e.g., joint replacement), major abdominal, intracranial, cardiovascular, spinal and any other surgery which had a significant risk of large volume blood loss or blood loss into a confined anatomical space. Several tooth extractions or extraction of the third molar were generally considered as major.
771757|NCT01507896|O1|Outcome|All Surgeries|All participants treated with BAX326 per surgical procedure. Data is reported per number of surgical procedures as opposed to number of unique participants as a unique participant can have more than one surgical procedure.
771758|NCT01507896|E1|Reported Event|All Participants|All unique participants treated with BAX326 per planned surgical procedure.
771759|NCT01507831|B3|Baseline|Total|Total of all reporting groups
771760|NCT01507831|B2|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771761|NCT01507831|B1|Baseline|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771762|NCT01507831|P2|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771763|NCT01507831|P1|Participant Flow|Placebo Q2W|Placebo (for alirocumab) subcutaneous (SC) injection every 2 weeks (Q2W) added to stable lipid modifying therapy (LMT) for 78 weeks.
771764|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771765|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771766|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771767|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771768|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771769|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771770|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771771|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771772|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771773|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771774|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771775|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771776|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771777|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771778|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771779|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771785|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771786|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771787|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771788|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771789|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771790|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771791|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
816611|NCT01339897|E4|Reported Event|Placebo|Non-Active
771794|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771795|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771796|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771797|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771798|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771799|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771800|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771801|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771802|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771803|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771804|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771805|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771806|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771807|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771808|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771809|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771810|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771811|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771812|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771813|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771814|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771815|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771816|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771817|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771818|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771819|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771820|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771821|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771822|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771823|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771824|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771825|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771826|NCT01507831|O2|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771827|NCT01507831|O1|Outcome|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771828|NCT01507831|E2|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable LMT for 78 weeks.
771829|NCT01507831|E1|Reported Event|Placebo Q2W|Placebo (for alirocumab) SC injection Q2W added to stable LMT for 78 weeks.
771830|NCT01507662|B3|Baseline|Total|Total of all reporting groups
771831|NCT01507662|B2|Baseline|Control|Usual care
771832|NCT01507662|B1|Baseline|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
771833|NCT01507662|P2|Participant Flow|Control|Usual care
771834|NCT01507662|P1|Participant Flow|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
771836|NCT01507662|O1|Outcome|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
771837|NCT01507662|E2|Reported Event|Control|Usual care
771838|NCT01507662|E1|Reported Event|BMD Result Letter and Brochure|"Patients who receive the intervention - BMD result letter with brochure~Bone Mineral Density Result Letter and Bone Health Brochure: Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information."
771840|NCT01507493|B2|Baseline|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771841|NCT01507493|B1|Baseline|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771842|NCT01507493|P2|Participant Flow|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771843|NCT01507493|P1|Participant Flow|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771844|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771845|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771846|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771847|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771848|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771849|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771850|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771851|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771852|NCT01507493|O2|Outcome|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771853|NCT01507493|O1|Outcome|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771854|NCT01507493|E2|Reported Event|Wild-type Alleles|grouped by SCN9A wild-type alleles including 3312G, 1719C, 1150R.
771855|NCT01507493|E1|Reported Event|Mutant Alleles|grouped by SCN9A mutant alleles including 3312T, 1719R, 1150W.
771856|NCT01507246|B3|Baseline|Total|Total of all reporting groups
771857|NCT01507246|B2|Baseline|EXPAREL Group|Group receiving EXPAREL
771858|NCT01507246|B1|Baseline|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
771859|NCT01507246|P2|Participant Flow|EXPAREL Group|Group receiving EXPAREL
771860|NCT01507246|P1|Participant Flow|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
771861|NCT01507246|O2|Outcome|EXPAREL Group|Group receiving EXPAREL
771862|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
771863|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
771864|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
771865|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
771866|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
771867|NCT01507246|O2|Outcome|EXPAREL|Group receiving EXPAREL
771868|NCT01507246|O1|Outcome|PCA/Opioid Group|Group receiving standardized IV morphine or Sponsor-approved equivalent via PCA pump postsurgically, as need.
771869|NCT01507246|E2|Reported Event|EXPAREL Group|Group receiving EXPAREL
771870|NCT01507246|E1|Reported Event|PCA/Opioid Group|Group receiving standardized IV morphine sulfate or Sponsor-approved equivalent via PCA pump postsurgically, as needed.
771871|NCT01507233|B3|Baseline|Total|Total of all reporting groups
771872|NCT01507233|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771873|NCT01507233|B1|Baseline|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
771874|NCT01507233|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771875|NCT01507233|P1|Participant Flow|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
771986|NCT01507090|O1|Outcome|2D-TAPE|Study coordinators performing measurements
771987|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771876|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771877|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
771993|NCT01507051|B4|Baseline|Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
771994|NCT01507051|B3|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
816612|NCT01339897|E3|Reported Event|Cohort 3|N6022 - Active 20 mg
771878|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771879|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
771880|NCT01507233|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771881|NCT01507233|O1|Outcome|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
771882|NCT01507233|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome injectable suspension)~EXPAREL (bupivacaine liposome injectable suspension): Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771883|NCT01507233|E1|Reported Event|IV Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~IV morphine sulfate: Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour."
771884|NCT01507220|B3|Baseline|Total|Total of all reporting groups
771885|NCT01507220|B2|Baseline|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771886|NCT01507220|B1|Baseline|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
771887|NCT01507220|P2|Participant Flow|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771888|NCT01507220|P1|Participant Flow|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
771889|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771890|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
771988|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771989|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771990|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771891|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771995|NCT01507051|B2|Baseline|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
771892|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
771893|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771894|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
771895|NCT01507220|O2|Outcome|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771896|NCT01507220|O1|Outcome|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
771897|NCT01507220|E2|Reported Event|EXPAREL|"EXPAREL (bupivacaine liposome extended-release injectable suspension)~bupivacaine liposome extended-release injectable suspension: Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.~All patients will be offered rescue analgesia, as needed."
771898|NCT01507220|E1|Reported Event|Morphine Sulfate|"morphine sulfate (or Sponsor-approved equivalent)~morphine sulfate: Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump."
771899|NCT01507181|B3|Baseline|Total|Total of all reporting groups
771900|NCT01507181|B2|Baseline|Midazolam|single dose IV midazolam, .45mg/kg
771901|NCT01507181|B1|Baseline|Ketamine|single dose IV ketamine, .5mg/kg
771902|NCT01507181|P2|Participant Flow|Midazolam|"single dose IV midazolam, .45mg/kg~Midazolam: single dose IV midazolam, .45mg/kg infused over 40 minutes"
771903|NCT01507181|P1|Participant Flow|Ketamine|"single dose IV ketamine, .5mg/kg~Ketamine: single dose IV ketamine, .5mg/kg infused over 40 minutes"
771904|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771905|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771906|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771907|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771908|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771909|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771910|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771911|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771912|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771913|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771914|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771915|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771916|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771917|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771918|NCT01507181|O2|Outcome|Midazolam|single dose IV midazolam, .045mg/kg
771919|NCT01507181|O1|Outcome|Ketamine|single dose IV ketamine, .5mg/kg
771920|NCT01507181|E2|Reported Event|Midazolam|single dose IV midazolam, .45mg/kg
771921|NCT01507181|E1|Reported Event|Ketamine|single dose IV ketamine, .5mg/kg
771922|NCT01507155|B1|Baseline|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
771923|NCT01507155|P2|Participant Flow|Patient-Reported Measures|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
771924|NCT01507155|P1|Participant Flow|Clincian-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
771997|NCT01507051|P4|Participant Flow|Group D: Warfarin Alone|Days -6 to -1 (could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR
771925|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
771926|NCT01507155|O1|Outcome|Clinician's Utilizing Assay Guided Treatment in Psychiatry|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
771927|NCT01507155|E2|Reported Event|Patient-Reported Outcomes|Patients age 18 and older with a diagnosis of Major Depressive Disorder or Generalized Anxiety disorder who receive genetic testing using the Genecept Assay and used self-reported patient scales to measure clinical improvements.
771928|NCT01507155|E1|Reported Event|Clinician-Reported Outcomes|"Prescribing clinicians responsible for the treatment of patients age 18 and older with a primary diagnosis of Major Depressive Disorder or Generalized Anxiety disorder, and for whom the Genecept Assay has been utilized to perform genetic testing.~Genecept Assay: Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders"
771929|NCT01507103|B4|Baseline|Total|Total of all reporting groups
771930|NCT01507103|B3|Baseline|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771931|NCT01507103|B2|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771932|NCT01507103|B1|Baseline|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771933|NCT01507103|P3|Participant Flow|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771934|NCT01507103|P2|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771935|NCT01507103|P1|Participant Flow|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771936|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771937|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771938|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771939|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771940|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771941|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771942|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771943|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771991|NCT01507090|E1|Reported Event|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771992|NCT01507051|B5|Baseline|Total|Total of all reporting groups
771996|NCT01507051|B1|Baseline|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
816613|NCT01339897|E2|Reported Event|Cohort 2|N6022 Active - 10 mg
771944|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771945|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771946|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771947|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771948|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771949|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771950|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771951|NCT01507103|O3|Outcome|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771952|NCT01507103|O2|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771953|NCT01507103|O1|Outcome|Chemoradiotherapy+Tecemotide (L-BLP25)+Cyclophosphamide|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771954|NCT01507103|E3|Reported Event|Chemoradiotherapy|Radiotherapy of 45-52 Gy will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-FU will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
771955|NCT01507103|E2|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)|Weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771956|NCT01507103|E1|Reported Event|Chemoradiotherapy+Tecemotide (L-BLP25)+CPA|Single dose of cyclophosphamide (300 mg/m^2 to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (actual delivered dose was 806 mcg) administered concomitantly with chemotherapy for 8 weeks, followed by a 9th subcutaneous vaccination 7 to 11 days prior to surgery.
771957|NCT01507090|B1|Baseline|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771958|NCT01507090|P1|Participant Flow|Normal Children|Otherwise healthy children 2 months to 16 years of age were enrolled. The 2D and 3D Mercy TAPE was developed to measure two upper arm landmarks so as to arrive at the weight estimate for a given child. The 2D Mercy TAPE requires two serial measurements with simple addition. The 3D TAPE makes both measurements simultaneously also requiring simple addition.
771959|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771960|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771961|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771962|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771963|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771964|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771965|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771966|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771967|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771968|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771969|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771970|NCT01507090|O2|Outcome|3D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771971|NCT01507090|O1|Outcome|2D-TAPE|Otherwise healthy children 2 months to 16 years of age.
771972|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771973|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771974|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771975|NCT01507090|O1|Outcome|Normal Children|Otherwise healthy children 2 months to 16 years of age.
771998|NCT01507051|P3|Participant Flow|Group C: Rivaroxaban Without Any Pre-treatment With Warfarin|Days 0 to 3: 20 mg rivaroxaban once daily
771999|NCT01507051|P2|Participant Flow|Group B: Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772000|NCT01507051|P1|Participant Flow|Group A: Warfarin Followed by Rivaroxaban|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772001|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772002|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772003|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772004|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772005|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772006|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772007|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772008|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772009|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772010|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772011|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772012|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772013|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772014|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772015|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772016|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772017|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772018|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772019|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772020|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772021|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772022|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772023|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
776386|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
772024|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772025|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772026|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772027|NCT01507051|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772028|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772029|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772030|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772031|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772032|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772033|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772034|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772035|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772036|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772037|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772038|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772039|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772040|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772041|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772042|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772043|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772044|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772045|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772046|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772047|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772296|NCT01505881|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
772048|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772049|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772050|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772306|NCT01505881|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
772051|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772052|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772053|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772054|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772055|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772056|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772057|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772058|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772059|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772060|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772061|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772062|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772063|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772064|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772065|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772066|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772067|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772068|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772069|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772070|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772071|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772072|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772073|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772074|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772075|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772076|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772077|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772078|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772079|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772080|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772081|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772082|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772083|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772084|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772085|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772086|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772087|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772088|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772089|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772090|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772091|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772092|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772093|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772094|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772095|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772096|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772097|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772098|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772099|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772100|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772101|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772102|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772297|NCT01505881|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
791997|NCT01433263|O1|Outcome|30mg/kg BYM338|
772103|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772104|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772105|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772106|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772107|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772108|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772109|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772110|NCT01507051|O3|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
772111|NCT01507051|O2|Outcome|Warfarin Followed by Placebo|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily
772112|NCT01507051|O1|Outcome|Warfarin Followed by Rivaroxaban (Xarelto, BAY59-7939)|Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily
772113|NCT01507051|E4|Reported Event|RG4: Warfarin Alone|All participants received warfarin in the Run-In Phase, who either received rivaroxaban or placebo afterwards, or discontinued the study. Days -6 to -1(could be prolonged by 2 days): dose 15 mg to 2.5 mg, dosing depending on INR. Note: Safety Data presented here include participants listed in Groups A, B (warfarin run-in only) and D of the Participant Flow section.
772114|NCT01507051|E3|Reported Event|RG3: Rivaroxaban|All participants received rivaroxaban. Days 0 to 3: 20 mg rivaroxaban once daily. Note: Safety Data presented here include participants listed in Group C of the Participant Flow section.
772115|NCT01507051|E2|Reported Event|RG2: Warfarin Followed by Placebo|All participants received warfarin and later placebo. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 1 tablet matching placebo once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group B of the Participant Flow section.
772116|NCT01507051|E1|Reported Event|RG1: Warfarin Followed by Rivaroxaban|All participants received warfarin and later rivaroxaban. Days -6 and -5: 10 mg warfarin once daily or lower depending on INR; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin once daily depending on INR; Days 0 to 3: 20 mg rivaroxaban once daily; Day 5: 10 mg vitamin K once daily. Note: Safety Data presented here include participants listed in Group A of the Participant Flow section.
772117|NCT01506960|B1|Baseline|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
772118|NCT01506960|P1|Participant Flow|Coronary Stenting With OCT, NIRS/IVUS|All subjects will have Near Infrared Spectroscopy/Intravascular Ultrasound Imaging performed.
772119|NCT01506960|O2|Outcome|Deep Lipid|
772120|NCT01506960|O1|Outcome|Superficial Lipid|
772121|NCT01506960|O1|Outcome|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
772122|NCT01506960|E1|Reported Event|Subjects Having NIRS/IVUS and OCT Imaging During PCI.|
772123|NCT01506947|B1|Baseline|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772124|NCT01506947|P1|Participant Flow|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772125|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772126|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772127|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772128|NCT01506947|O2|Outcome|Month 6|
772129|NCT01506947|O1|Outcome|Baseline|
772130|NCT01506947|O2|Outcome|Month 6|
772131|NCT01506947|O1|Outcome|Baseline|
772298|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
772132|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772133|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772134|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772135|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772136|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772137|NCT01506947|O1|Outcome|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772138|NCT01506947|E1|Reported Event|Paricalcitol|"Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.~Participants may have also received routine darbepoetin alfa to treat anemia."
772139|NCT01506908|B3|Baseline|Total|Total of all reporting groups
772140|NCT01506908|B2|Baseline|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772141|NCT01506908|B1|Baseline|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772142|NCT01506908|P2|Participant Flow|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772143|NCT01506908|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg)|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772144|NCT01506908|O2|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772145|NCT01506908|O1|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772146|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772147|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772148|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772149|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772150|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772151|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772152|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772153|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772154|NCT01506908|O2|Outcome|Matched Placebo|Participants received a single dose of matched placebo mint lozenge, through oral route.
772155|NCT01506908|O1|Outcome|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772156|NCT01506908|E2|Reported Event|Placebo Lozenge|Participants received a single dose of matched placebo mint lozenge, through oral route.
772157|NCT01506908|E1|Reported Event|Nicotine Lozenge 4 mg|Participants received a single dose of 4 mg nicotine polacrilex mint lozenge, through oral route.
772158|NCT01506882|B3|Baseline|Total Title|
772159|NCT01506882|B2|Baseline|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
772160|NCT01506882|B1|Baseline|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
772161|NCT01506882|P2|Participant Flow|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
772162|NCT01506882|P1|Participant Flow|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
772163|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
772299|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
772164|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
772307|NCT01505881|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
772308|NCT01505764|B3|Baseline|Total|Total of all reporting groups
772165|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
772166|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
772167|NCT01506882|O1|Outcome|Full Analysis Set (LEV 3000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
772168|NCT01506882|O1|Outcome|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
772169|NCT01506882|O1|Outcome|Full Analysis Set (LEV 1000 mg/Day to 2000 mg/Day Group)|"FAS includes all subjects in the Safety Set who had at least 1 treatment day in the Evaluation Period. This means that subjects in LEV 1000 to 2000 mg/day group had to have at least 1 treatment day in the Evaluation Period on their final evaluated dose.~Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
772170|NCT01506882|O1|Outcome|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
772171|NCT01506882|E2|Reported Event|Levetiracetam 3000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.~Frequency: Twice daily"
772172|NCT01506882|E1|Reported Event|Levetiracetam 1000 mg/Day to 2000 mg/Day Group|"Formulation: Tablet~Strength: LEV 250 mg, LEV 500 mg~Dosage: First study dose is 1000 mg/day and if a seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.~Frequency: Twice daily"
772173|NCT01506726|B3|Baseline|Total|Total of all reporting groups
772174|NCT01506726|B2|Baseline|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772175|NCT01506726|B1|Baseline|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772176|NCT01506726|P2|Participant Flow|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772177|NCT01506726|P1|Participant Flow|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772178|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772179|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772223|NCT01506596|E1|Reported Event|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772180|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772181|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772182|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772183|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772184|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772185|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772186|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772187|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772188|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772189|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772190|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772191|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772192|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772193|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772300|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
773027|NCT01499862|O2|Outcome|Patient 2|Five Times Sit to Stand Test (seconds)
772194|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772195|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772196|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772197|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772198|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772199|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772200|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772201|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772202|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772203|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772204|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772205|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772206|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772207|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772301|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
772828|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772208|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772209|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772210|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772211|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772212|NCT01506726|O2|Outcome|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772213|NCT01506726|O1|Outcome|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772214|NCT01506726|E2|Reported Event|Placebo Arm|"Subjects randomized to the placebo arm will receive a matching placebo pill (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 2 matching placebo pills twice a day (if the one pill dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Placebo: Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months"
772215|NCT01506726|E1|Reported Event|Active Drug - Oral Salsalate|"Subjects randomized to active drug arm will receive 750mg of salsalate (one pill) twice a day (am and pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a day (if the 750mg dose was tolerated) for a further 5 months. Total treatment time is 6 months.~Salsalate: Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)"
772216|NCT01506596|B1|Baseline|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772217|NCT01506596|P1|Participant Flow|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772218|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772219|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772220|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772221|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772222|NCT01506596|O1|Outcome|Pazopanib|"Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.~pazopanib: Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity."
772829|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772276|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772349|NCT01505608|O2|Outcome|Arm A- TMZ + Irinotecan Only|Did not receive TPI 287
772224|NCT01506362|B1|Baseline|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
772225|NCT01506362|P1|Participant Flow|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
772226|NCT01506362|O1|Outcome|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
772227|NCT01506362|E1|Reported Event|A Synthetic Oligonucleotide for Treatment of IBD.|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~BL-7040: BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
772228|NCT01506323|B3|Baseline|Total|Total of all reporting groups
772229|NCT01506323|B2|Baseline|Present Centered Therapy (PCT)|Present Centered Individual Therapy (PCT): The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
772230|NCT01506323|B1|Baseline|Mantram Repetition Program (MRP)|The Mantram Repetition Program (MRP) teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772231|NCT01506323|P2|Participant Flow|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically avoids actual details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training.
772232|NCT01506323|P1|Participant Flow|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP was delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772233|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCIT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772234|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772235|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772302|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator.
772830|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772236|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772237|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772238|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772239|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772240|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772241|NCT01506323|O2|Outcome|Arm 2: Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772242|NCT01506323|O1|Outcome|Arm 1: Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772243|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772244|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772245|NCT01506323|O2|Outcome|Present Centered Therapy|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772274|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772831|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772246|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772247|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)`|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772248|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772249|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772250|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772251|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772252|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772253|NCT01506323|O2|Outcome|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772254|NCT01506323|O1|Outcome|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772255|NCT01506323|E2|Reported Event|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It typically details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention comparison arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
772275|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772303|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
772256|NCT01506323|E1|Reported Event|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
772257|NCT01506193|B4|Baseline|Total|Total of all reporting groups
772258|NCT01506193|B3|Baseline|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772259|NCT01506193|B2|Baseline|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772260|NCT01506193|B1|Baseline|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772261|NCT01506193|P3|Participant Flow|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772262|NCT01506193|P2|Participant Flow|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772263|NCT01506193|P1|Participant Flow|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772264|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772265|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772266|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772267|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772268|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772269|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772270|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772271|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772272|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772273|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772428|NCT01504867|E1|Reported Event|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772277|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772278|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772279|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772280|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772281|NCT01506193|O3|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772282|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772283|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772284|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772285|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772286|NCT01506193|O2|Outcome|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772287|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772288|NCT01506193|O2|Outcome|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772289|NCT01506193|O1|Outcome|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772290|NCT01506193|E3|Reported Event|Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine at Visit 1 (Day 0) and Priorix-Tetra™ vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772291|NCT01506193|E2|Reported Event|Priorix-Tetra Group|Healthy male or female subjects between 13 to 15 months of age who received Priorix-Tetra™ vaccine at Visit 1 (Day 0) and Meningitec® vaccine at Visit 2 (Days 35-49). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772292|NCT01506193|E1|Reported Event|Priorix-Tetra + Meningitec Group|Healthy male or female subjects between 13 to 15 months of age who received Meningitec® vaccine co-administered along with Priorix-Tetra™ vaccine at Visit 1 (Day 0). Priorix-Tetra™ vaccine was administered subcutaneously in the deltoid region of the left arm and Meningitec® vaccine was administered intramuscularly in the tricep of the right arm.
772293|NCT01505881|B3|Baseline|Total|Total of all reporting groups
772294|NCT01505881|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
772295|NCT01505881|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
772304|NCT01505881|O2|Outcome|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
772305|NCT01505881|O1|Outcome|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily.
772309|NCT01505764|B2|Baseline|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
772310|NCT01505764|B1|Baseline|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
772311|NCT01505764|P2|Participant Flow|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
772312|NCT01505764|P1|Participant Flow|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
772313|NCT01505764|O2|Outcome|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
772314|NCT01505764|O1|Outcome|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
772315|NCT01505764|E2|Reported Event|Arm 2|"Placebo~Placebo: Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day."
772316|NCT01505764|E1|Reported Event|Arm 1|"Anamorelin HCl~Anamorelin HCl: 100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day."
772317|NCT01505647|B3|Baseline|Total|Total of all reporting groups
772318|NCT01505647|B2|Baseline|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772319|NCT01505647|B1|Baseline|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772320|NCT01505647|P2|Participant Flow|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772321|NCT01505647|P1|Participant Flow|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live Alternative Manufacturing Process (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772322|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772323|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772324|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772325|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772326|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772327|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772328|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772329|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772330|NCT01505647|O2|Outcome|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772331|NCT01505647|O1|Outcome|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772332|NCT01505647|E2|Reported Event|ZOSTAVAX™|Zoster Vaccine, Live : One approximately 0.65-mL injection subcutaneously on Day 1
772333|NCT01505647|E1|Reported Event|ZOSTAVAX™ (AMP)|Zoster Vaccine, Live (AMP) : One approximately 0.65-mL injection subcutaneously on Day 1
772334|NCT01505608|B3|Baseline|Total|Total of all reporting groups
772335|NCT01505608|B2|Baseline|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772336|NCT01505608|B1|Baseline|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772337|NCT01505608|P2|Participant Flow|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772429|NCT01504854|B3|Baseline|Total|Total of all reporting groups
772338|NCT01505608|P1|Participant Flow|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~During Phase 2- Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772378|NCT01504997|P1|Participant Flow|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
772339|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772340|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772341|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772342|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772343|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772344|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772345|NCT01505608|O2|Outcome|Arm B- Temozolomide/Irinotecan + TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772346|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772347|NCT01505608|O2|Outcome|Phase I Patients + Phase II Assigned Arm B- Tmz +I+ TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772430|NCT01504854|B2|Baseline|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
772348|NCT01505608|O1|Outcome|Arm A- Temozolomide and Irinotecan|"Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~Patients who show progression on the I+TMZ arm may crossover to the I+TMZ+TPI 287 arm at anytime during cycles 1 to 6. If there is evidence of progression after completion of the I+TMZ arm (after completion of cycle 6) then the patient will have been considered to have completed therapy and is not eligible for the crossover.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
816614|NCT01339897|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
772350|NCT01505608|O1|Outcome|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772351|NCT01505608|E2|Reported Event|Phase II Arm A- Subjects That Did Not Receive TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772352|NCT01505608|E1|Reported Event|TPI 287|"Cycle 1 to 6: Irinotecan and Temozolomide in combination with TPI 287~Intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle.~Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.~TPI 287: Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.~Temozolomide: Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle~Irinotecan: Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle."
772353|NCT01505387|B3|Baseline|Total|Total of all reporting groups
772354|NCT01505387|B2|Baseline|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
772355|NCT01505387|B1|Baseline|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
772356|NCT01505387|P2|Participant Flow|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
772357|NCT01505387|P1|Participant Flow|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
772358|NCT01505387|O2|Outcome|Litramine|"Fibre complex of plant origin n tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
772359|NCT01505387|O1|Outcome|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
772360|NCT01505387|E2|Reported Event|Litramine|"Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)~Litramine: Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)"
772361|NCT01505387|E1|Reported Event|Placebo|"Identical to Litramine 2 tablets 3 times daily (oral consumption, after meal)~Placebo: Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)"
772362|NCT01505374|B1|Baseline|All Study Participants|
772363|NCT01505374|P2|Participant Flow|Study Technique Left Leg, Control Technique Right Leg|
772364|NCT01505374|P1|Participant Flow|Study Technique Right Leg, Control Technique Left Leg|
772365|NCT01505374|O1|Outcome|All Patients|
772366|NCT01505374|O1|Outcome|All Patients|
772367|NCT01505374|O1|Outcome|All Patients|
772368|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
772369|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
772370|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
772371|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
772372|NCT01505374|O1|Outcome|All Patients|
772373|NCT01505374|O2|Outcome|Control Technique: Femoral Nerve Block|Control Technique: The other leg will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
772866|NCT01500317|B3|Baseline|Placebo|Placebo tid
772374|NCT01505374|O1|Outcome|Study Technique: Saphenous Nerve Block|Study Technique: One leg will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
772375|NCT01505374|E2|Reported Event|Control Technique: Femoral Nerve Block|
772376|NCT01505374|E1|Reported Event|Study Technique: Saphenous Nerve Block|
772377|NCT01504997|B1|Baseline|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
772379|NCT01504997|O1|Outcome|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
772380|NCT01504997|E1|Reported Event|Robot Assisted Distal Gastrectomy|"patients who received robot assisted distal gastrectomy~Robot assisted distal gastrectomy (DaVinci): patients who received robot assisted distal gastrectomy"
772381|NCT01504971|B1|Baseline|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
772382|NCT01504971|P1|Participant Flow|Gastroesophageal Reflux Disease (GERD)|"symptom questionaire: GerdQ questionaire~pH monitoring: 24-hour pH monitoring~Tri-modal imaging endoscopy: To investigate WLI,NBI and AFI~rabeprazole: 10mg, bid, p.o."
772383|NCT01504971|O3|Outcome|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
772384|NCT01504971|O2|Outcome|Participants Same to arm1|Diagnostic capabilities of Autofluorescence Imaging on Gastroesophageal Reflux Disease
772385|NCT01504971|O1|Outcome|Participants|Diagnostic capabilities of White-light Imaging on Gastroesophageal Reflux Disease
772386|NCT01504971|E3|Reported Event|Participants Same to Previous Arm|Diagnostic capabilities of GerdQ in the diagnosis of GERD
772387|NCT01504971|E2|Reported Event|Participants Same to arm1|Diagnostic capabilities of AFI in the diagnosis of GERD
772388|NCT01504971|E1|Reported Event|Participants|Diagnostic capabilities of WLI in the diagnosis of GERD
772389|NCT01504958|B4|Baseline|Total|Total of all reporting groups
772390|NCT01504958|B3|Baseline|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
772391|NCT01504958|B2|Baseline|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772392|NCT01504958|B1|Baseline|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772393|NCT01504958|P3|Participant Flow|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
772394|NCT01504958|P2|Participant Flow|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772867|NCT01500317|B2|Baseline|Oxycodone|5 mg oxycodone tid
772395|NCT01504958|P1|Participant Flow|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772596|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772396|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
772397|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772398|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772399|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
772400|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772401|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772402|NCT01504958|O3|Outcome|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
772431|NCT01504854|B1|Baseline|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772868|NCT01500317|B1|Baseline|Tapentadol|75 mg tapentadol tid
772403|NCT01504958|O2|Outcome|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772404|NCT01504958|O1|Outcome|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772405|NCT01504958|E3|Reported Event|Sham rTMS With Sham Cognitive Training|"High frequency sham rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~Sham Cognitive Training: subjects will undergo pseudo cognitive training with the sham rTMS following the same procedures as the active group"
772406|NCT01504958|E2|Reported Event|Sham rTMS With Real Cognitive Training|"High frequency sham rTMS to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772407|NCT01504958|E1|Reported Event|Active rTMS With Real Cognitive Training|"High frequency rTMS stimulation to the left and right parietal cortex (somatosensory association cortex), left and right DLPFC (dorsolateral prefrontal cortex), and left superior temporal gyrus (Broca's area).~Repetitive Transcranial Magnetic Stimulation (rTMS): Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).~Sham participants will receive the same study procedures as patients receiving active rTMS.~NICE Cognitive Training: 12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).~A particular cognitive exercise will start 200msec after the termination of each TMS train.~Sham participants receive real cognitive training that follows the same procedures as the active group."
772408|NCT01504867|B3|Baseline|Total|Total of all reporting groups
772409|NCT01504867|B2|Baseline|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772410|NCT01504867|B1|Baseline|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772411|NCT01504867|P2|Participant Flow|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772412|NCT01504867|P1|Participant Flow|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772413|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772414|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772415|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772416|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772417|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772418|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772419|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772420|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772421|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772422|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772423|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772424|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772425|NCT01504867|O2|Outcome|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772426|NCT01504867|O1|Outcome|Aspirin|This arm received a 325mg loading dose of aspirin on study day one, followed by 81mg of aspirin on days 2-7.
772427|NCT01504867|E2|Reported Event|Placebo|This group received matching lactose powder filled capsules on days 1-7.
772432|NCT01504854|P2|Participant Flow|Placebo|"Subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
772433|NCT01504854|P1|Participant Flow|Resveratrol|"Subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772434|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
776387|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
772435|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772436|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
772437|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772438|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
772439|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772440|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
772441|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772442|NCT01504854|O2|Outcome|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
772443|NCT01504854|O1|Outcome|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772444|NCT01504854|E2|Reported Event|Placebo|"60 subjects will receive a matching placebo to be taken with or without food.~Placebo: The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily."
772445|NCT01504854|E1|Reported Event|Resveratrol|"60 subjects will take 500 mg by mouth once daily increasing at 13 week intervals to a maximum of 1 gram by mouth twice daily with or without food.~Resveratrol: The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily)."
772446|NCT01503749|B4|Baseline|Total|Total of all reporting groups
772447|NCT01503749|B3|Baseline|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
772448|NCT01503749|B2|Baseline|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
772449|NCT01503749|B1|Baseline|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
772450|NCT01503749|P3|Participant Flow|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
772451|NCT01503749|P2|Participant Flow|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
772869|NCT01500317|P3|Participant Flow|Placebo|Placebo tid
772452|NCT01503749|P1|Participant Flow|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
772473|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772497|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772453|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
772454|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
772455|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
772456|NCT01503749|O3|Outcome|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
772457|NCT01503749|O2|Outcome|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
772458|NCT01503749|O1|Outcome|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
772459|NCT01503749|E3|Reported Event|Infusion of the Mobilized Peripheral Blood Mononucleated Cells|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells~. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.~Infusion of the mobilized peripheral blood mononucleated cells: G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance."
772460|NCT01503749|E2|Reported Event|G-colony Stimulating Factor|"G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm.~G-colony stimulating factor: G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm."
772461|NCT01503749|E1|Reported Event|Control|Three patients with liver cirrhosis of this arm will not receive any intervention regarding to peripheral blood mononucleated cells
772462|NCT01503021|B3|Baseline|Total|Total of all reporting groups
772463|NCT01503021|B2|Baseline|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
772464|NCT01503021|B1|Baseline|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µM (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
772465|NCT01503021|P2|Participant Flow|Placebo/SFP|Standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks.
772466|NCT01503021|P1|Participant Flow|SFP/Placebo|Soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate x 2 weeks, then 1 week washout, then standard liquid bicarbonate concentrate without SFP x 2 weeks
772467|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772468|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772469|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772470|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772471|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772472|NCT01503021|O1|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772589|NCT01502371|P4|Participant Flow|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
772496|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772474|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772475|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772476|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772477|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772478|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772479|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772480|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772481|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772482|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772483|NCT01503021|O2|Outcome|Placebo/SFP|"Parent Study: Blinded standard liquid bicarbonate concentrate without SFP x 2 weeks, then 1 week washout, then soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate x 2 weeks.~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772484|NCT01503021|O1|Outcome|SFP/Placebo|"Parent Study: Blinded soluble ferric pyrophosphate (SFP) 2 µmoles (110 µg) iron/L of dialysate, then 1 week washout, then blinded standard liquid bicarbonate concentrate without SFP x 2 weeks~SFP: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate~Placebo: Dialysis with standard liquid bicarbonate concentrate without iron"
772485|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772486|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772487|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772488|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772489|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772490|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772491|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772492|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772493|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772590|NCT01502371|P3|Participant Flow|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772494|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772495|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772499|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772500|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772501|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772502|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772503|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772504|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772505|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772506|NCT01503021|O3|Outcome|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772507|NCT01503021|O2|Outcome|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772508|NCT01503021|O1|Outcome|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772509|NCT01503021|E3|Reported Event|Open-label Soluble Ferric Pyrophosphate|Extension Study: Open-label soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772510|NCT01503021|E2|Reported Event|Placebo|Parent Study: Blinded standard liquid bicarbonate concentrate
772511|NCT01503021|E1|Reported Event|Soluble Ferric Pyrophosphate|Parent Study: Blinded soluble ferric pyrophosphate administered via the liquid bicarbonate concentrate to yield a final dialysate concentration of 2 micromolar (110 micrograms) iron/liter.
772512|NCT01502787|B1|Baseline|All Participants|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period , there will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
772513|NCT01502787|P2|Participant Flow|Nebivolol First, Then Metoprolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
772514|NCT01502787|P1|Participant Flow|Metoprolol First Then Nebivolol|"The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.~Metoprolol succinate: The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued."
772515|NCT01502787|O2|Outcome|Second Intervention Nebivolol: 24 Weeks|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks.
772516|NCT01502787|O1|Outcome|First Intervention Metoprolol: 12 Weeks|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
772591|NCT01502371|P2|Participant Flow|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772517|NCT01502787|E2|Reported Event|Nebivolol 21 Subjects|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
772594|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772595|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
772518|NCT01502787|E1|Reported Event|Metoprolol 21 Subjects|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued. There will be a 2-week washout period. Following washout, the subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks.
772519|NCT01502709|B3|Baseline|Total|Total of all reporting groups
772520|NCT01502709|B2|Baseline|Placebo Arm|0 participants received placebo
772521|NCT01502709|B1|Baseline|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
772522|NCT01502709|P2|Participant Flow|Placebo Arm|0 participants received placebo
772523|NCT01502709|P1|Participant Flow|Caloric Vestibular Neurostimulation|1 treatment of caloric vestibular neurostimulation for 7.5 minutes in the right ear
772524|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
772525|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
772526|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
772527|NCT01502709|O1|Outcome|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
772528|NCT01502709|O2|Outcome|Placebo Arm|0 participants received placebo
772529|NCT01502709|O1|Outcome|Neurostimulator|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
772530|NCT01502709|E2|Reported Event|Placebo Arm|0 participants received placebo
772531|NCT01502709|E1|Reported Event|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
772532|NCT01502644|B4|Baseline|Total|Total of all reporting groups
772533|NCT01502644|B3|Baseline|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772534|NCT01502644|B2|Baseline|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772535|NCT01502644|B1|Baseline|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772536|NCT01502644|P4|Participant Flow|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772537|NCT01502644|P3|Participant Flow|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772538|NCT01502644|P2|Participant Flow|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772539|NCT01502644|P1|Participant Flow|Enrolled at Visit 1|All participants who satisfied pre-screening requirements and were enrolled at Visit 1.
772540|NCT01502644|O3|Outcome|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772870|NCT01500317|P2|Participant Flow|Oxycodone|5 mg oxycodone tid
772541|NCT01502644|O2|Outcome|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772542|NCT01502644|O1|Outcome|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772543|NCT01502644|E3|Reported Event|High NA|Participants with high NA (HADS score ≥9 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772544|NCT01502644|E2|Reported Event|Moderate NA|Participants with moderate NA (HADS score ≥6 to ≤8 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772545|NCT01502644|E1|Reported Event|Low NA|Participants with low NA (HADS score ≤5 on each subscale) received placebo or active opioid drug (immediate-release morphine 15 to 30 mg or oxycodone 5 to 10 mg) up to three times a day as needed for 1 week each in random order, followed by morphine or oxycodone titrated to a maximum allowable daily dose in morphine equivalents of 30 mg for short-acting medication and 60 mg for long-acting medication, respectively, three times a day for up to 20 weeks, followed by morphine or oxycodone tapering (individualized opioid dose was decreased by approximately 25% each week) for 4 weeks.
772546|NCT01502423|B3|Baseline|Total|Total of all reporting groups
772547|NCT01502423|B2|Baseline|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
772548|NCT01502423|B1|Baseline|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
772549|NCT01502423|P2|Participant Flow|New Formulation of Adalimumab/Current Formulation Adalimumab|First dose with 40 mg of new formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of current formulation of adalimumab in a pre-filled syringe.
772550|NCT01502423|P1|Participant Flow|Current Formulation Adalimumab/New Formulation of Adalimumab|First dose with 40 mg of current formulation of adalimumab in a pre-filled syringe and second dose with 40 mg of new formulation of adalimumab in a pre-filled syringe.
772551|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772552|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772553|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772554|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772555|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772556|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772557|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772558|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772559|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772560|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772561|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772562|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772563|NCT01502423|O2|Outcome|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772564|NCT01502423|O1|Outcome|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772565|NCT01502423|E2|Reported Event|New Formulation of Adalimumab|One dose with 40 mg of new formulation of adalimumab in a pre-filled syringe
772566|NCT01502423|E1|Reported Event|Current Formulation Adalimumab|One dose with 40 mg of current formulation of adalimumab in a pre-filled syringe
772567|NCT01502410|B5|Baseline|Total|Total of all reporting groups
772568|NCT01502410|B4|Baseline|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772815|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772569|NCT01502410|B3|Baseline|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
776388|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
772570|NCT01502410|B2|Baseline|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772571|NCT01502410|B1|Baseline|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772572|NCT01502410|P4|Participant Flow|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772573|NCT01502410|P3|Participant Flow|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772574|NCT01502410|P2|Participant Flow|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772575|NCT01502410|P1|Participant Flow|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772576|NCT01502410|O4|Outcome|Group 4 Papillary Thyroid Carcinoma|"Patients with relapsed or refractory papillary thyroid carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772577|NCT01502410|O3|Outcome|Group 3 Relapsed/Refractory Hepatocellular Carcinoma|"Patients with relapsed or refractory hepatocellular carcinoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772578|NCT01502410|O2|Outcome|Group 2 Relapsed/Refractory Wilms Tumor|"Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772579|NCT01502410|O1|Outcome|Group 1 Relapsed/Refractory Rhabdomyosarcoma|"Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28~pharmacological study: Optional correlative studies~laboratory biomarker analysis: Optional correlative studies"
772580|NCT01502410|E2|Reported Event|Group 2 Relapsed/Refractory Wilms Tumor|Patients with relapsed or refractory Wilms tumor receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
772581|NCT01502410|E1|Reported Event|Group 1 Relapsed/Refractory Rhabdomyosarcoma|Patients with relapsed or refractory rhabdomyosarcoma receive sorafenib tosylate PO BID on days 1-28. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.
772582|NCT01502371|B6|Baseline|Total|Total of all reporting groups
772583|NCT01502371|B5|Baseline|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772584|NCT01502371|B4|Baseline|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
772585|NCT01502371|B3|Baseline|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772586|NCT01502371|B2|Baseline|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772587|NCT01502371|B1|Baseline|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772588|NCT01502371|P5|Participant Flow|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772871|NCT01500317|P1|Participant Flow|Tapentadol|75 mg tapentadol tid
772592|NCT01502371|P1|Participant Flow|MF MDI 50 mcg BID|Participants receive mometasone furoate (MF) metered dose inhaler (MDI) 25 mcg x 2 inhalations (50 mcg total dose) twice daily (BID) PLUS Placebo dry powder inhaler (DPI) x 1 inhalation once daily (QD) in the evening for 12 weeks.
772593|NCT01502371|O2|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
772597|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772598|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772599|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772600|NCT01502371|O5|Outcome|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
772601|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772602|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772603|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772604|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772605|NCT01502371|O4|Outcome|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772606|NCT01502371|O3|Outcome|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772607|NCT01502371|O2|Outcome|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772608|NCT01502371|O1|Outcome|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772609|NCT01502371|E5|Reported Event|Placebo|Participants receive Placebo MDI x 2 inhalations BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772610|NCT01502371|E4|Reported Event|MF DPI 100 mcg QD|Participants receive Placebo MDI x 2 inhalations BID PLUS MF DPI x 1 inhalation QD in the evening for 12 weeks.
772611|NCT01502371|E3|Reported Event|MF MDI 200 mcg BID|Participants receive MF MDI 100 mcg x 2 inhalations (200 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772612|NCT01502371|E2|Reported Event|MF MDI 100 mcg BID|Participants receive MF MDI 50 mcg x 2 inhalations (100 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772613|NCT01502371|E1|Reported Event|MF MDI 50 mcg BID|Participants receive MF MDI 25 mcg x 2 inhalations (50 mcg total dose) BID PLUS Placebo DPI x 1 inhalation QD in the evening for 12 weeks.
772614|NCT01502332|B3|Baseline|Total|Total of all reporting groups
772615|NCT01502332|B2|Baseline|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772616|NCT01502332|B1|Baseline|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772617|NCT01502332|P2|Participant Flow|Moderate Alveolar Recruitment|Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772618|NCT01502332|P1|Participant Flow|Intensive Alveolar Recruitment|Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772619|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772620|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772621|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772622|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772623|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772624|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772625|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772816|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772872|NCT01500317|O3|Outcome|Placebo|Placebo tid
772626|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772627|NCT01502332|O2|Outcome|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772628|NCT01502332|O1|Outcome|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772832|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772833|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772629|NCT01502332|E2|Reported Event|Moderate Alveolar Recruitment ARM|Mechanical ventilation strategy: Moderate alveolar recruitment ARM: recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772630|NCT01502332|E1|Reported Event|Intensive Alveolar Recruitment ARM|Mechanical ventilation strategy: Intensive Alveolar Recruitment ARM: recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
772631|NCT01502228|B1|Baseline|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
772632|NCT01502228|P1|Participant Flow|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
772633|NCT01502228|O1|Outcome|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
772634|NCT01502228|O1|Outcome|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
772635|NCT01502228|E1|Reported Event|62Cu-ETS PET Assessment|"CT scan for attenuation correction; 15O-water administered by intravenous injection and 6-minute dynamic PET imaging; 62Cu-ETS administered by intravenous injection; Dynamic PET acquisition for 6-minutes; Whole-body PET acquisition from 6-20 minutes post-62Cu-ETS injection 150-Water: Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.~62Cu-ethylglyoxal bis: Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV. Positron Emission Tomography: PET Scan Sunitinib"
772636|NCT01502033|B1|Baseline|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
772637|NCT01502033|P1|Participant Flow|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
772817|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772818|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772638|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation: 30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment"
772639|NCT01502033|O1|Outcome|Open Label Active Treatment|All participants had unblended treatment
817964|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
772640|NCT01502033|O1|Outcome|Transcranial Magnetic Stimulation|"Open-label course of 30 daily treatments with repetitive transcranial magnetic stimulation (rTMS) at 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.~Transcranial Magnetic Stimulation"
772641|NCT01502033|E1|Reported Event|Open Label Active Treatment|All participants had unblinded treatment
772642|NCT01501162|B3|Baseline|Total|Total of all reporting groups
772643|NCT01501162|B2|Baseline|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
772644|NCT01501162|B1|Baseline|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
772645|NCT01501162|P2|Participant Flow|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
772646|NCT01501162|P1|Participant Flow|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
772647|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
772648|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
772649|NCT01501162|O2|Outcome|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
772650|NCT01501162|O1|Outcome|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
772651|NCT01501162|E2|Reported Event|Hepatitis, Alcohol, Probiotics|7 days of probiotics (1500 mg/day)
772652|NCT01501162|E1|Reported Event|Alcohol, Hepatitis, Placebo|Placebo (for probiotics) for 7 days Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
772653|NCT01501110|B3|Baseline|Total|Total of all reporting groups
772654|NCT01501110|B2|Baseline|no Intervention|No intervention / usual care
772655|NCT01501110|B1|Baseline|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
772656|NCT01501110|P2|Participant Flow|no Intervention|No intervention / usual care
772657|NCT01501110|P1|Participant Flow|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
772658|NCT01501110|O2|Outcome|no Intervention|No intervention / usual care
772659|NCT01501110|O1|Outcome|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
772660|NCT01501110|E2|Reported Event|no Intervention|No intervention / usual care
772661|NCT01501110|E1|Reported Event|N-acetylcysteine|"intra-venous infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours.~N-acetylcysteine: in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours"
772662|NCT01500772|B1|Baseline|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
772663|NCT01500772|P1|Participant Flow|Alisporivir|Alisporivir (ALV) 400 mg twice daily (BID), with peginterferon alfa-2a (PEG) and ribavirin (RBV) for 48 weeks.
772664|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
772665|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
772666|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
772667|NCT01500772|O1|Outcome|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
772668|NCT01500772|E1|Reported Event|Alisporivir|ALV 400 mg BID with PEG and RBV for 48 weeks.
772669|NCT01500746|B3|Baseline|Total|Total of all reporting groups
772670|NCT01500746|B2|Baseline|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
772671|NCT01500746|B1|Baseline|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
772672|NCT01500746|P2|Participant Flow|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
772673|NCT01500746|P1|Participant Flow|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
772674|NCT01500746|O2|Outcome|Moist Dressings|This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.
772675|NCT01500746|O1|Outcome|Lavage Arm|This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.
772819|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772820|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772676|NCT01500746|E2|Reported Event|Moist Dressings|"This group will serve as the control group. They will undergo twice daily dressing changes with moist gauze dressings for a total of 4 days (8 dressing changes). Bacterial counts and gene expression analysis will be performed prior to the first dressing change and after the last dressing change.~Dressing changes: Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments)."
772834|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772677|NCT01500746|E1|Reported Event|Lavage Arm|"This group will serve as the experimental arm. They will undergo twice daily pulse lavage of their wounds for 4 days. In between the lavage treatments, their wounds will be dressed with moist gauze.~Pulse lavage treatment: A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments)."
772678|NCT01500720|B3|Baseline|Total|Total of all reporting groups
772679|NCT01500720|B2|Baseline|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772680|NCT01500720|B1|Baseline|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772681|NCT01500720|P2|Participant Flow|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772682|NCT01500720|P1|Participant Flow|Cabazitaxel|Cabazitaxel (XRP6258) 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772683|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772684|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772685|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772686|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772687|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772688|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772689|NCT01500720|O2|Outcome|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772690|NCT01500720|O1|Outcome|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772691|NCT01500720|E2|Reported Event|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772692|NCT01500720|E1|Reported Event|Cabazitaxel|Cabazitaxel 25 mg/m^2 IV on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
772693|NCT01500694|B3|Baseline|Total|Total of all reporting groups
772694|NCT01500694|B2|Baseline|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772695|NCT01500694|B1|Baseline|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772696|NCT01500694|P2|Participant Flow|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772697|NCT01500694|P1|Participant Flow|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 milligram [mg] or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772698|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772699|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772700|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772701|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772702|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772703|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772704|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772705|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772821|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772873|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
772706|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772835|NCT01500434|E1|Reported Event|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772836|NCT01500382|B5|Baseline|Total|Total of all reporting groups
772707|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772708|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772709|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772710|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772711|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772712|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772713|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772714|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772715|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772716|NCT01500694|O2|Outcome|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772717|NCT01500694|O1|Outcome|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772718|NCT01500694|E2|Reported Event|SPD503 (13-18 Years)|Participants aged 13-18 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772719|NCT01500694|E1|Reported Event|SPD503 (6-12 Years)|Participants aged 6-12 years received extended-release guanfacine hydrochloride (SPD503) one tablet (1 x 1 mg or 2 mg or 3 mg or 4mg) or two tablets (1 x 2+3 mg or 1 x 2+4 mg, 1 x 3+4 mg) once daily for up to 2 years.
772720|NCT01500629|B3|Baseline|Total|Total of all reporting groups
772721|NCT01500629|B2|Baseline|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772722|NCT01500629|B1|Baseline|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772723|NCT01500629|P2|Participant Flow|Placebo Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772724|NCT01500629|P1|Participant Flow|C-1266-7 Then Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772725|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772822|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772823|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772874|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
773139|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
773140|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
772726|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772727|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772728|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772729|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772730|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772731|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772732|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772733|NCT01500629|O2|Outcome|C-1266-6 Then C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772734|NCT01500629|O1|Outcome|C-1266-7 Then C-1266-6|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772735|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772736|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772737|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772875|NCT01500317|O3|Outcome|Placebo|Placebo tid
772738|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772739|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772740|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772741|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772742|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772743|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772744|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772745|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772746|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772747|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772748|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772749|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772876|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
772750|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772751|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772752|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772753|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772754|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772755|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772756|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772757|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772758|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772759|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772760|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772761|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772877|NCT01500317|O1|Outcome|Tapentadol|75 mg tapentadol tid
772762|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772763|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772764|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772765|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772766|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772767|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772768|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772769|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772770|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772771|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772772|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772773|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772878|NCT01500317|O3|Outcome|Placebo|Placebo tid
772774|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772775|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772776|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772777|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772778|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772779|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772780|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772781|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772782|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772783|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772784|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772785|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772879|NCT01500317|O2|Outcome|Oxycodone|5 mg oxycodone tid
772786|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772787|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772788|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772789|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772790|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772791|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772792|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772793|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772794|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772795|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772796|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772824|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772825|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772826|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772827|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772797|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772798|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772799|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo).. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo).: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772800|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772801|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6, (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772802|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772803|NCT01500629|O2|Outcome|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6 (placebo). After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772804|NCT01500629|O1|Outcome|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6 (placebo).~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~C-1266-6 (placebo): Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment."
772805|NCT01500629|E2|Reported Event|Placebo|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-6. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-7.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772806|NCT01500629|E1|Reported Event|C-1266-7|"In a crossover design with subjects randomized to treatment sequence, each subject will receive 200 uL of device Intervention C-1266-7. After a washout period of approximately 14 days, subjects will receive 200 uL of device Intervention C-1266-6.~C-1266-7: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.~Placebo: Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6) in each nostril, for a total of 200 uL per treatment."
772807|NCT01500434|B1|Baseline|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772808|NCT01500434|P1|Participant Flow|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772809|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772810|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772811|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772812|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772813|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772814|NCT01500434|O1|Outcome|PROMUS Element|Patients who received the PROMUS™ Element Everolimus-Eluting Coronary Stent
772837|NCT01500382|B4|Baseline|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
772838|NCT01500382|B3|Baseline|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
772839|NCT01500382|B2|Baseline|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
772840|NCT01500382|B1|Baseline|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
772841|NCT01500382|P4|Participant Flow|Placebo → Vibegron 50 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 50 mg and placebo to match tolterodine ER.
772842|NCT01500382|P3|Participant Flow|Placebo → Tolterodine 4 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily tolterodine 4 mg and placebo to match vibegron.
772843|NCT01500382|P2|Participant Flow|Placebo → Vibegron 100 mg|During Treatment Period 1, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once daily vibegron 100 mg and placebo to match tolterodine ER.
772844|NCT01500382|P1|Participant Flow|Vibegron 100 mg + Tolterodine 4 mg → Placebo|During Treatment Period 1, participants received 7 days of once-daily vibegron 100 mg and tolterodine extended-release (ER) 4 mg. Participants then completed a 2-week single-blind double-dummy placebo washout period prior to Treatment Period 2. During Treatment Period 2, participants received 7 days of once-daily placebo to match vibegron and placebo to match tolterodine ER.
772845|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772846|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
772847|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
772848|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772849|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772850|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
772851|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
772852|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772853|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772854|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
772855|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
772856|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772857|NCT01500382|O4|Outcome|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772858|NCT01500382|O3|Outcome|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
772859|NCT01500382|O2|Outcome|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
772860|NCT01500382|O1|Outcome|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772861|NCT01500382|E4|Reported Event|Placebo|Participants received 7 days of once-daily placebo to match vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772862|NCT01500382|E3|Reported Event|Vibegron 50 mg|Participants received 7 days of once-daily vibegron 50 mg and placebo to match tolterodine ER 4 mg.
772863|NCT01500382|E2|Reported Event|Vibegron 100 mg + Tolterodine ER 4 mg|Participants received 7 days of once-daily vibegron 100 mg and tolterodine ER 4 mg.
772864|NCT01500382|E1|Reported Event|Vibegron 100 mg|Participants received 7 days of once-daily vibegron 100 mg and placebo to match tolterodine ER 4 mg.
772865|NCT01500317|B4|Baseline|Total|Total of all reporting groups
772946|NCT01500226|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy.~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy."
773141|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
817965|NCT01333592|E2|Reported Event|KAD-1229 / Biguanides|
772891|NCT01500278|B2|Baseline|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772892|NCT01500278|B1|Baseline|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772893|NCT01500278|P2|Participant Flow|ADA+MTX (RTG)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772894|NCT01500278|P1|Participant Flow|CZP+MTX (RTG)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772895|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772896|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772897|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772898|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772899|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772900|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
773028|NCT01499862|O1|Outcome|Patient 1|Five Times Sit to Stand Test (seconds)
773029|NCT01499862|O3|Outcome|Patient 3|Timed Up and Go Test (seconds)
772901|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772902|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772903|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772904|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772905|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772906|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772907|NCT01500278|O2|Outcome|ADA+MTX (Week 12 Responder Set)|"ADA 40 mg at Baseline and then every 2 Weeks until Week 102. Subjects received PBO in addition to ADA at baseline and weeks 2 and 4 in order to maintain the blinding.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772908|NCT01500278|O1|Outcome|CZP+MTX (Week 12 Responder Set)|"CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 102.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772909|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
773030|NCT01499862|O2|Outcome|Patient 2|Timed Up and Go Test (seconds)
773031|NCT01499862|O1|Outcome|Patient 1|Timed Up and Go Test (seconds)
772910|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772911|NCT01500278|O2|Outcome|ADA+MTX (FAS)|"Subjects received ADA 40mg (40mg/PFS, ie, 1 injection) at Baseline and then every 2 weeks through Week 10. In order to preserve the blind (ie, use of 2 injections) until Week 12, subjects received an injection of PBO in addition to ADA at Baseline, and Weeks 2 and 4.~Week 12 Responders continued ADA 40mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to a loading dose of CZP 400mg at Weeks 12, 14, and 16 followed by CZP 200mg every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued CZP treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772912|NCT01500278|O1|Outcome|CZP+MTX (FAS)|"Subjects received loading doses of CZP 400mg (200mg/PFS, ie, 2 injections) at Baseline, and Weeks 2 and 4; and CZP 200mg at Weeks 6, 8, and 10.~Week 12 Responders continued CZP 200mg at Week 12 and every 2 weeks thereafter through Week 102.~Week 12 Non-Responders were switched to receive ADA 40mg at Week 12 and every 2 weeks through Week 22. At Week 24, Week 12 Non-Responders who did not have DAS28(ESR) LDA or a DAS28(ESR) change from Week 12 reduction of ≥1.2 discontinued ADA treatment and were withdrawn from the Treatment Period.~All subjects received Methotrexate 15 to 25mg/week orally or subcutaneously from Baseline through Week 104. Regimens could have been changed at Week 52 only. Subjects who could not tolerate these doses could receive MTX at a minimum dose of 10mg/week orally or subcutaneously."
772913|NCT01500278|E2|Reported Event|ADA+MTX (SS)|All subjects who received at least 1 dose of Adalimumab (ADA). All adverse events that occurred when the subject was receiving ADA treatment are summarized in this group.
772914|NCT01500278|E1|Reported Event|CZP+MTX (SS)|All subjects who received at least 1 dose of Certolizumab pegol (CZP). All adverse events that occurred when the subject was receiving CZP treatment are summarized in this group.
772915|NCT01500252|B3|Baseline|Total|Total of all reporting groups
772916|NCT01500252|B2|Baseline|Patellar Retention|Subjects retained their native patella.
772917|NCT01500252|B1|Baseline|Patellar Resurfacing|Subjects received patellar resurfacing.
772918|NCT01500252|P2|Participant Flow|Patellar Retention|Subjects retained their native patella.
772919|NCT01500252|P1|Participant Flow|Patellar Resurfacing|Subjects received patellar resurfacing.
772920|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772921|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772922|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772923|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772924|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772925|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing
772926|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772927|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772928|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772929|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772930|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772931|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772932|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772933|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772934|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772935|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772936|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772937|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772938|NCT01500252|O2|Outcome|Patellar Retention|Subjects retained their native patella.
772939|NCT01500252|O1|Outcome|Patellar Resurfacing|Subjects received patellar resurfacing.
772940|NCT01500252|E2|Reported Event|Patellar Retention|Subjects retained their native patella.
772941|NCT01500252|E1|Reported Event|Patellar Resurfacing|Subjects received patellar resurfacing.
772942|NCT01500226|B3|Baseline|Total|Total of all reporting groups
772943|NCT01500226|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772944|NCT01500226|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772945|NCT01500226|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
773032|NCT01499862|O3|Outcome|Patient 3|Six Minute Walk Test (meters)
773033|NCT01499862|O2|Outcome|Patient 2|Six Minute Walk Test (meters)
773034|NCT01499862|O1|Outcome|Patient 1|Six Minute Walk Test (meters)
772947|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772948|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772949|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772950|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772951|NCT01500226|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772952|NCT01500226|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy"
772953|NCT01500226|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~685 subjects were randomized to control~674 of those who were randomized to control received control in C1~Safety = 674 control"
772954|NCT01500226|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (2 mg orally) about 30 min before chemotherapy. Subsequently, granisetron 2mg was administered orally to all patients once daily on days 2–3~Dexamethasone (20 mg orally) about 30 min before chemotherapy~684 subjects were randomized to Rolapitant~670 of those randomized to Rolapitant received rolapitant in C1~Safety = 670 Rolapitant"
772955|NCT01500213|B3|Baseline|Total|Total of all reporting groups
772956|NCT01500213|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772957|NCT01500213|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772958|NCT01500213|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772959|NCT01500213|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772960|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772961|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772962|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772963|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772964|NCT01500213|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772965|NCT01500213|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
772966|NCT01500213|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4~277 subjects were randomized to control;~274 of those who were randomized to control received control in C1.~Safety = 274 control"
772967|NCT01500213|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4~278 subjects were randomized to Rolapitant~272 of those randomized to Rolapitant received Rolapitant in C1~Safety = 272 Rolapitant"
772968|NCT01500135|B3|Baseline|Total|Total of all reporting groups
772969|NCT01500135|B2|Baseline|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772970|NCT01500135|B1|Baseline|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772971|NCT01500135|P2|Participant Flow|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772972|NCT01500135|P1|Participant Flow|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772973|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772974|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772975|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772976|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772977|NCT01500135|O2|Outcome|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772978|NCT01500135|O1|Outcome|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772979|NCT01500135|E2|Reported Event|Surgicel® Original|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772980|NCT01500135|E1|Reported Event|TachoSil®|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The patches were lightly compressed against the suture line for 3 minutes. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
772981|NCT01500109|B4|Baseline|Total|Total of all reporting groups
772982|NCT01500109|B3|Baseline|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
772983|NCT01500109|B2|Baseline|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
773220|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773037|NCT01499849|B2|Baseline|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773225|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
772984|NCT01500109|B1|Baseline|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
772985|NCT01500109|P3|Participant Flow|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
772986|NCT01500109|P2|Participant Flow|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
772987|NCT01500109|P1|Participant Flow|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
772988|NCT01500109|O3|Outcome|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
772989|NCT01500109|O2|Outcome|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
772990|NCT01500109|O1|Outcome|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
772991|NCT01500109|E3|Reported Event|Opioid Only|"This group will receive placebo oral cherry elixir prior to going to the operating room and placebo Ofirmev® after securing intravenous access in the operating room with redosing every six hours. They will receive local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to incision as well as at the completion of surgery with Bupivicaine 0.25% with Epinephrine. Postoperatively they will receive only Morphine prn for pain control.~Opioid only: Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed."
773035|NCT01499862|E1|Reported Event|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
772992|NCT01500109|E2|Reported Event|Oral Acetaminophen|"Patients will receive oral acetaminophen cherry elixir preoperatively. After intravenous access is obtained intraoperatively patients will receive placebo for Ofirmev (saline). Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon prior to surgical incision as wel as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patient will receive oral acetaminophen every six hours and intravenous placebo (normal saline) for intravenous acetaminophen. Intravenous morphine will be administered as needed for 24 hours.~Oral acetaminophen: Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care t"
772993|NCT01500109|E1|Reported Event|Ofirmev®|"Oral inert cherry syrup will be administered preoperatively as placebo for oral acetaminophen. Ofirmev will be administered in the operating room once intravenous access is established. Patients will receive standardized dose of local anesthetic (Lidocaine 0.5% with Epinephrine) infiltration by the surgeon before surgical incision as well as at the completion of surgery with Bupivacaine 0.25% with Epinephrine. Postoperatively patients will receive Ofirmev® every 6 hours as well as placebo oral cherry elixir every 6 hours and morphine as needed for 24 hours.~Ofirmev®: Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia c"
772994|NCT01500083|B3|Baseline|Total|Total of all reporting groups
772995|NCT01500083|B2|Baseline|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
772996|NCT01500083|B1|Baseline|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
772997|NCT01500083|P2|Participant Flow|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
772998|NCT01500083|P1|Participant Flow|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
772999|NCT01500083|O2|Outcome|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
773000|NCT01500083|O1|Outcome|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
773001|NCT01500083|E2|Reported Event|Patients With iNHL|Patients with iNHL will receive bendamustine at a dose of 120 mg/m2 on Days 1 and 2 in treatment cycles of 21 or 28 days for up to eight cycles. Bendamustine will be administered intravenous (i.v.) over 60 minutes.
773002|NCT01500083|E1|Reported Event|Patients With Previously Untreated CLL|Patients with CLL will receive bendamustine at a dose of 100 mg/m2 on Days 1 and 2 in treatment cycles of 28 days for up to six cycles. Bendamustine will be administered i.v. over 30 minutes.
773003|NCT01500031|B1|Baseline|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
773004|NCT01500031|P1|Participant Flow|Re-ROUTE|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with the OffRoad™ Re-entry Catheter
773005|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773006|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773007|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773008|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773009|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773010|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773011|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773012|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773013|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773014|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773015|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773016|NCT01500031|O1|Outcome|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773017|NCT01500031|E1|Reported Event|OffRoad Re-entry Catheter|Participants treated with OffRoad Re-entry Catheter System
773018|NCT01499862|B1|Baseline|All Participants|All subjects had reached plateau with conventional Bodyweight-Supported Treadmill Training (BWSTT, participated in task-oriented mobility therapy(1.5 hours, 2-4 times per week for 4 weeks) with Robotic Leg Orthosis (RLO) under the supervision of a physical therapist.
773019|NCT01499862|P1|Participant Flow|Tibion Arm Baseline Assessments|Arm of the study in which enrolled post-stroke subjects undergo rehabilitative therapy with the Tibion Bionic Leg.
773020|NCT01499862|O3|Outcome|Patient 3|Ambulation speed (meters/second)
773021|NCT01499862|O2|Outcome|Patient 2|Ambulation speed (meters/second)
773022|NCT01499862|O1|Outcome|Patient 1|Ambulation speed (meters/second)
773023|NCT01499862|O3|Outcome|Patient 3|Step Length (meters)
773024|NCT01499862|O2|Outcome|Patient 2|Step Length (meters)
773025|NCT01499862|O1|Outcome|Patient 1|Step Length (meters)
773026|NCT01499862|O3|Outcome|Patient 3|Five Times Sit to Stand Test (seconds)
773038|NCT01499849|B1|Baseline|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773039|NCT01499849|P2|Participant Flow|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773040|NCT01499849|P1|Participant Flow|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773041|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773042|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773043|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773044|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773045|NCT01499849|O2|Outcome|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773046|NCT01499849|O1|Outcome|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773047|NCT01499849|E2|Reported Event|Placebo + Granisetron + Dexamethasone|"Matching placebo 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773048|NCT01499849|E1|Reported Event|Rolapitant + Granisetron + Dexamethasone|"Oral dose of rolapitant 180 mg (equivalent to 200 mg rolapitant hydrochloride monohydrate) 1–2 h before administration of chemotherapy~Granisetron (10 μg/kg intravenously) about 30 min before chemotherapy~Dexamethasone (20 mg orally) about 30 min before chemotherapy, and dexamethasone 8 mg orally twice daily on days 2–4"
773049|NCT01499810|B1|Baseline|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773050|NCT01499810|P1|Participant Flow|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773051|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773117|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773118|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773136|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
773137|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
773138|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
773052|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773053|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773054|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergone bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) was inserted into renal artery and 4-10 point ablations were performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation was performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773055|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773056|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773057|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773058|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773059|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773119|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773120|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773121|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773060|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773061|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773062|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773063|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773064|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773065|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773066|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773067|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773122|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773123|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773124|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773068|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773069|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773070|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773071|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773072|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773073|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773074|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773075|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773125|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773126|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773127|NCT01499667|E3|Reported Event|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773076|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773077|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773078|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773079|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773080|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773081|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773082|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773083|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773128|NCT01499667|E2|Reported Event|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773129|NCT01499667|E1|Reported Event|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773130|NCT01499654|B1|Baseline|Study Group|Entire cohort
773131|NCT01499654|P1|Participant Flow|Study Group|Entire cohort
773214|NCT01499290|O3|Outcome|CAZ (2)|30-90 mins after dose
773084|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773085|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773086|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773087|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773088|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773089|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773090|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773091|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773132|NCT01499654|O3|Outcome|Injection 1 to Injection 2|Time in minutes between the first 1/2 dose injection and the second 1/2 dose injection
773133|NCT01499654|O2|Outcome|Injection 2 to Scan 2|Time in minutes between the second 1/2 dose injection and the second scan.
773134|NCT01499654|O1|Outcome|Injection 1 to Scan 1|Time in minutes between the first 1/2 dose injection and the first scan
773135|NCT01499654|O1|Outcome|Study Group|Entire cohort
773215|NCT01499290|O2|Outcome|AVI (1)|30 min before/after dose
773092|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773093|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773094|NCT01499810|O1|Outcome|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773095|NCT01499810|E1|Reported Event|Renal Denervation|"All eligible patients undergo bilateral radiofrequency sympathetic renal denervation using endocardial ablation system: after standard renal angiography using femoral access a small size endocardial ablation catheter (5-6 F, 4 mm electrode) is inserted into renal artery and 4-8 point ablations are performed consecutively from distal part to aorta with 3-4 mm step and 90 degrees rotation on the upper, lower, front and back aspects of the artery to get circumferential coverage, then the procedure is repeated on the other side.~Bilateral radiofrequency sympathetic renal denervation: Bilateral radiofrequency sympathetic renal denervation is performed as percutaneous transluminal radiofrequency (RF) ablation of neural pathways in the renal artery walls and surrounding tissue using standard equipment for RF ablation of cardiac electrical pathways"
773096|NCT01499667|B4|Baseline|Total|Total of all reporting groups
773097|NCT01499667|B3|Baseline|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod
773098|NCT01499667|B2|Baseline|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773099|NCT01499667|B1|Baseline|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773100|NCT01499667|P3|Participant Flow|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773101|NCT01499667|P2|Participant Flow|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773102|NCT01499667|P1|Participant Flow|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773103|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773104|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773105|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773106|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773107|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773108|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773109|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773110|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773111|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773112|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773113|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773114|NCT01499667|O1|Outcome|8-week Washout + Fingolimod (FTY720)|8-week washout (8 weeks no treatment) followed by 24 weeks of treatment with fingolimod 0.5mg once a day
773115|NCT01499667|O3|Outcome|16-week Washout + Fingolimod (FTY720)|16-week washout (8 weeks no treatment and 8 weeks placebo) followed by 16 weeks of treatment with fingolimod 0.5mg once a day
773116|NCT01499667|O2|Outcome|12-week Washout + Fingolimod (FTY720)|12-week washout (8 weeks no treatment and 4 weeks placebo) followed by 20 weeks of treatment with fingolimod 0.5mg once a day
773142|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
773143|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
773144|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
773145|NCT01499654|O3|Outcome|Full-dose FBP|Full-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
773146|NCT01499654|O2|Outcome|Half-dose FBP|Half-dose Tc-99m sestamibi reconstructed using filtered back projection (FBP)
773147|NCT01499654|O1|Outcome|Half-dose WBR|Half-dose Tc-99m sestamibi reconstructed using wide beam reconstruction (WBR)
773148|NCT01499654|E1|Reported Event|Study Group|Entire cohort for the study
773149|NCT01499576|B1|Baseline|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
773150|NCT01499576|P1|Participant Flow|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
773151|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
773152|NCT01499576|O1|Outcome|Acetic Acid Spraying|The same participants primary outcome analysed
773153|NCT01499576|O1|Outcome|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
773154|NCT01499576|E1|Reported Event|Acetic Acid Spraying|Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.
773155|NCT01499498|B1|Baseline|Sildenafil and Boceprevir|All subjects take single dose sildenafil 25mg day 0, day 10-15 they take boceprevir 800mg three times a day followed by Intentive PK on day 15 and on day 16 single dose of sildenafil and boceprevir together followed by intensive PK
773156|NCT01499498|P1|Participant Flow|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
773157|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
773158|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
773159|NCT01499498|O1|Outcome|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir: 25mg once/800mg three times a day"
773160|NCT01499498|O1|Outcome|Bocepreprivir Alone|"Healthy volunteers~Boceprevir: 800mg three times a day"
773161|NCT01499498|O1|Outcome|Sildenafil Only|"Healthy volunteers~Sildenafil 25mg once"
773162|NCT01499498|E1|Reported Event|Sildenafil and Boceprevir|"Healthy volunteers~Sildenafil and Boceprevir : 25mg once daily/800mg three times a day"
773163|NCT01499355|B1|Baseline|All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
773164|NCT01499355|P4|Participant Flow|Double-Blind Period: BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
773165|NCT01499355|P3|Participant Flow|Double-Blind Period: BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
773166|NCT01499355|P2|Participant Flow|Double-Blind Period: Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy of oral steroids (prednisone or equivalent) and MMF.
773167|NCT01499355|P1|Participant Flow|Run-In Period: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received mycophenolate mofetil (MMF) starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
773168|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773169|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773170|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773171|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773172|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773173|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773216|NCT01499290|O1|Outcome|CAZ (1)|30 mins before/after dose
773217|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773218|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773219|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773174|NCT01499355|O1|Outcome|Run-In: All Enrolled Participants|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
773226|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
773175|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773176|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773177|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773178|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773179|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773180|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773181|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773182|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773183|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773184|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773185|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773186|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773187|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773188|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773189|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773190|NCT01499355|O3|Outcome|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773191|NCT01499355|O2|Outcome|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773192|NCT01499355|O1|Outcome|Placebo|Placebo IV infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773193|NCT01499355|E4|Reported Event|BIIB023 20 mg/kg|BIIB023 20 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773194|NCT01499355|E3|Reported Event|BIIB023 3 mg/kg|BIIB023 3 mg/kg IV on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48 plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773195|NCT01499355|E2|Reported Event|Placebo|Placebo intravenous (IV) infusion on Day 1, Week 2, Week 4, Week 8, and every 4 weeks thereafter through Week 48, plus background therapy including oral steroids (prednisone or equivalent) and MMF.
773196|NCT01499355|E1|Reported Event|Run-in Period|At Run-in Day 1, participants entering the study received oral corticosteroid (prednisone or equivalent) starting at 0.75 mg/kg/day (maximum allowed dose of 60 mg/day) for 2 weeks and subsequently tapered over an 8-week period to 10 mg/day by Run-in Week 10. Following confirmation of eligibility, subjects also received MMF starting at Run-in Day 1 at a total dose of 1 g/day and titrated to a target dose of 2 g/day by Run-in Week 2.
773197|NCT01499303|B3|Baseline|Total|Total of all reporting groups
773198|NCT01499303|B2|Baseline|200mg BID|200mg Fostmatinib BID
773199|NCT01499303|B1|Baseline|100mg BID|100mg Fostmatinib BID
773200|NCT01499303|P2|Participant Flow|200mg BID|200mg Fostmatinib BID
773201|NCT01499303|P1|Participant Flow|100mg BID|100mg Fostmatinib BID
773202|NCT01499303|O2|Outcome|200mg BID|200mg Fostmatinib BID
773203|NCT01499303|O1|Outcome|100mg BID|100mg Fostmatinib BID
773204|NCT01499303|E2|Reported Event|200mg BID|200mg Fostmatinib BID
773205|NCT01499303|E1|Reported Event|100mg BID|100mg Fostmatinib BID
773206|NCT01499290|B3|Baseline|Total|Total of all reporting groups
773207|NCT01499290|B2|Baseline|Meropenem|1000 mg: IV treatment
773208|NCT01499290|B1|Baseline|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773209|NCT01499290|P2|Participant Flow|Meropenem|1000 mg: IV treatment
773210|NCT01499290|P1|Participant Flow|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773211|NCT01499290|O6|Outcome|AVI (3)|300-360 mins after dose
773212|NCT01499290|O5|Outcome|CAZ (3)|300-360 mins after dose
773213|NCT01499290|O4|Outcome|AVI (2)|30-90 mins after dose
773221|NCT01499290|O4|Outcome|Meropenem (Denominator)|Number of patients with pathogen at baseline
773222|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Number of patients with pathogen at baseline
773223|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773224|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773230|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (Denominator)|Total number of patiets with each pathogen at baseline (summary only shows pathogens where N>/=10)
773231|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment. Number of favourable responses
773232|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment Number of favourable responses
773233|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
773234|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
773235|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
773236|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
773237|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours after last dose of study drug
773238|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours after last dose of study drug
773239|NCT01499290|O6|Outcome|Meropenem (LFU)|LFU - 42 to 49 days after start of study drug
773240|NCT01499290|O5|Outcome|CAZ-AVI + Metronidazole (LFU)|LFU - 42 to 49 days after start of study drug
773241|NCT01499290|O4|Outcome|Meropenem (TOC)|TOC - 28 to 35 days after start of study drug
773242|NCT01499290|O3|Outcome|CAZ-AVI + Metronidazole (TOC)|TOC - 28 to 35 days after start of study drug
773243|NCT01499290|O2|Outcome|Meropenem (EOT)|EOT - within 24 hours of last dose of study drug
773244|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole (EOT)|EOT - within 24 hours of last dose of study drug
773245|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773246|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773247|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773248|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773249|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773250|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773251|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773252|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773253|NCT01499290|O2|Outcome|Meropenem|1000 mg: IV treatment
773254|NCT01499290|O1|Outcome|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment
773255|NCT01499290|E2|Reported Event|Meropenem|1000 mg: IV treatment
773256|NCT01499290|E1|Reported Event|CAZ-AVI + Metronidazole|CAZ (2000mg)/AVI (500mg): IV treatment.
773257|NCT01499277|B3|Baseline|Total|Total of all reporting groups
773258|NCT01499277|B2|Baseline|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773259|NCT01499277|B1|Baseline|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773260|NCT01499277|P2|Participant Flow|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773261|NCT01499277|P1|Participant Flow|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773262|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773263|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773264|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773265|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773266|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773267|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773268|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773269|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773270|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773271|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773272|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773273|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773274|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773275|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773276|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773277|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773278|NCT01499277|O2|Outcome|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773279|NCT01499277|O1|Outcome|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773280|NCT01499277|E2|Reported Event|Vancomycin/Aztreonam|Vancomycin Plus Aztreonam
773281|NCT01499277|E1|Reported Event|Ceftaroline|Ceftaroline fosamil at 600 mg every 8 hours (q8h)
773282|NCT01499199|B1|Baseline|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773283|NCT01499199|P1|Participant Flow|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773284|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773353|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773285|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773286|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773287|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773288|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773289|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773290|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773291|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773292|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773293|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773294|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773295|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773296|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773297|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773298|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773299|NCT01499199|O1|Outcome|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773300|NCT01499199|E1|Reported Event|Dolutegravir 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) in combination with abacavir/lamivudine (ABC/3TC) OD.
773301|NCT01499147|B3|Baseline|Total|Total of all reporting groups
773302|NCT01499147|B2|Baseline|Arm 2|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
773303|NCT01499147|B1|Baseline|Arm 1|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
773304|NCT01499147|P2|Participant Flow|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
773305|NCT01499147|P1|Participant Flow|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
773306|NCT01499147|O2|Outcome|Fludarabine/Melphalan +ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
773307|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
773308|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).~ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
773309|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.~ATG: Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen."
773310|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
773311|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
773312|NCT01499147|O2|Outcome|Fludarabine/Melphalan + ATG|"All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.~fludarabine/ melphalan: All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl)."
773313|NCT01499147|O1|Outcome|Fludarabine/Busulfan + ATG|"All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.~fludarabine/busulfan: All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI."
773314|NCT01499147|E3|Reported Event|FluMel Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluMel and receiving PBSC.
773315|NCT01499147|E2|Reported Event|FluBu Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and receiving PBSC.
773316|NCT01499147|E1|Reported Event|Participants With Extra-hematological Toxicities|We analyzed if different rates of severe extra-hematological toxicities could be detected in patients conditioned with FluBu and FluMel and receiving PBSC.
773317|NCT01499134|B3|Baseline|Total|Total of all reporting groups
773318|NCT01499134|B2|Baseline|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773319|NCT01499134|B1|Baseline|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773320|NCT01499134|P2|Participant Flow|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773321|NCT01499134|P1|Participant Flow|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773322|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773323|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773324|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773325|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773326|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773327|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773354|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773355|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
776373|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
773328|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773329|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
776389|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
773330|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773331|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773332|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773333|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773334|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773335|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773336|NCT01499134|O2|Outcome|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773337|NCT01499134|O1|Outcome|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773338|NCT01499134|E2|Reported Event|Metoprolol Succinate|"metoprolol 1 to 4 capsules daily~Metoprolol succinate: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing)."
773339|NCT01499134|E1|Reported Event|Nebivolol|"nebivolol 1 to 4 capsules daily~nebivolol: Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing)."
773340|NCT01499095|B3|Baseline|Total|Total of all reporting groups
773341|NCT01499095|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773342|NCT01499095|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773343|NCT01499095|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
773344|NCT01499095|P1|Participant Flow|HOE901-U300|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s).
773345|NCT01499095|O2|Outcome|HOE901­U300: Fixed Dosing Intervals|HOE901­U300 SC injection once daily for 12 months in combination with of oral antidiabetic drug(s). From Month 6 up to Month 9 participants received HOE901­U300 once daily every 24 hours.
773346|NCT01499095|O1|Outcome|HOE901­U300: Adaptable Dosing Intervals|HOE901­U300 SC injection once daily for 6 months in combination with oral antidiabetic drug(s). From Month 6 to Month 9 participants received HOE901­U300 once daily at intervals of 24 +/­ 3 hours.
773347|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773348|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773349|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773350|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773351|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773352|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
776374|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
773356|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773357|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773358|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773359|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773360|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
776390|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
773361|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773362|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773363|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on in combination with antidiabetic drug(s).
773364|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773365|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773366|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773367|NCT01499095|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773368|NCT01499095|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773369|NCT01499095|E2|Reported Event|LANTUS|Lantus SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773370|NCT01499095|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months in combination with oral antidiabetic drug(s).
773371|NCT01499082|B3|Baseline|Total|Total of all reporting groups
773372|NCT01499082|B2|Baseline|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773373|NCT01499082|B1|Baseline|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773374|NCT01499082|P2|Participant Flow|Lantus|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue.
773375|NCT01499082|P1|Participant Flow|HOE901-U300|HOE901­U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue.
773376|NCT01499082|O2|Outcome|HOE901-U300: Fixed Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 up to Month 9 participants received HOE901-U300 once daily every 24 hours.
773377|NCT01499082|O1|Outcome|HOE901-U300: Adaptable Dosing Intervals|HOE901-U300 SC injection once daily for 6 months on top of mealtime insulin. From Month 6 to Month 9 participants received HOE901-U300 once daily at intervals of 24 +/- 3 hours.
773378|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773379|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773380|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773381|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773382|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773383|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773384|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773385|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773386|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773387|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773388|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773389|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773390|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773391|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773392|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773393|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773394|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773395|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773396|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773397|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773398|NCT01499082|O2|Outcome|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773399|NCT01499082|O1|Outcome|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773400|NCT01499082|E2|Reported Event|Lantus|Lantus SC injection once daily for 12 months on top of mealtime insulin.
773401|NCT01499082|E1|Reported Event|HOE901-U300|HOE901-U300 SC injection once daily for 12 months on top of mealtime insulin.
773402|NCT01498822|B3|Baseline|Total Title|
773403|NCT01498822|B2|Baseline|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
773404|NCT01498822|B1|Baseline|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
773405|NCT01498822|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
773406|NCT01498822|P1|Participant Flow|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
773407|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
773408|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
773409|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
773410|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
773411|NCT01498822|O2|Outcome|Full Analysis Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
773412|NCT01498822|O1|Outcome|Full Analysis Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
773413|NCT01498822|O2|Outcome|Per Protocol Set (OXC Treated Subjects)|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)
773414|NCT01498822|O1|Outcome|Per Protocol Set (LEV Treated Subjects)|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
773415|NCT01498822|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine twice a day treatment Group~150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1 week then 600 mg/day 1 week)"
773416|NCT01498822|E1|Reported Event|Levetiracetam|"Levetiracetam twice a day treatment Group~250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks"
773417|NCT01498744|B3|Baseline|Total|Total of all reporting groups
773418|NCT01498744|B2|Baseline|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773419|NCT01498744|B1|Baseline|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773420|NCT01498744|P2|Participant Flow|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773421|NCT01498744|P1|Participant Flow|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773422|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773423|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773424|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773451|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773452|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773425|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
776391|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
773426|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773427|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773428|NCT01498744|O2|Outcome|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773429|NCT01498744|O1|Outcome|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773430|NCT01498744|E2|Reported Event|1 Day Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773431|NCT01498744|E1|Reported Event|5 Days Postoperative Antibiotic|"Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).~Oral Clindamycin: Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours)."
773432|NCT01498692|B1|Baseline|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773433|NCT01498692|P1|Participant Flow|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773434|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773435|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773436|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773437|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773438|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773439|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773440|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773441|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773442|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773443|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773444|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773445|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773446|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773447|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773448|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773449|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773450|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773453|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773454|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773455|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773456|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773457|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773458|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773459|NCT01498692|O1|Outcome|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773460|NCT01498692|E1|Reported Event|PROMUS Element|Patients enrolled in the study to receive treatment with the PROMUS Element everolimus-eluting stent
773461|NCT01498679|B3|Baseline|Total|Total of all reporting groups
773462|NCT01498679|B2|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
773463|NCT01498679|B1|Baseline|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
773464|NCT01498679|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 100/25 micrograms (µg) OD in the evening,via a DPI, for a period of 12 weeks.
773465|NCT01498679|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773466|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
773467|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
773468|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
773469|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
773470|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
773471|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
773472|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
773473|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
773474|NCT01498679|O2|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
773475|NCT01498679|O1|Outcome|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
773476|NCT01498679|E2|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg Once Daily|Participants received FF/VI 100/25 µg OD in the evening,via a DPI, for a period of 12 weeks.
773477|NCT01498679|E1|Reported Event|Placebo|Participants received placebo OD in the evening,via a DPI, for a period of 12 weeks.
773478|NCT01498653|B3|Baseline|Total|Total of all reporting groups
773479|NCT01498653|B2|Baseline|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773480|NCT01498653|B1|Baseline|Fluticasone Furoate/Vilanterol 200/25 µg OD|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773481|NCT01498653|P2|Participant Flow|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773482|NCT01498653|P1|Participant Flow|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening,via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773483|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773484|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773485|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773486|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773487|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773488|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773489|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773490|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773491|NCT01498653|O2|Outcome|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773492|NCT01498653|O1|Outcome|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773493|NCT01498653|E2|Reported Event|Fluticasone Propionate 500 µg Twice Daily (BID)|Participants received fluticasone propionate (FP) 500 µg inhalation powder BID (in the morning and evening), via the DISKUS, for a period of 12 weeks.
773849|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773494|NCT01498653|E1|Reported Event|Fluticasone Furoate/Vilanterol 200/25 µg Once Daily|Participants received fluticasone furoate (FF)/vilanterol (VI) 200/25 micrograms (µg) once daily (OD) in the evening, via a Dry Powder Inhaler (DPI), for a period of 12 weeks.
773495|NCT01498640|B1|Baseline|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
773496|NCT01498640|P1|Participant Flow|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
773497|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
773498|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
773499|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
773500|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
773501|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
773502|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
773503|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
773504|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the PIP joint cord
773505|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the MP joint cord
773506|NCT01498640|O2|Outcome|XIAFLEX/XIAPEX PIP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the proximal interphalangeal (PIP) joint cord
773507|NCT01498640|O1|Outcome|XIAFLEX/XIAPEX MP Joint|Up to 3 injections of collagenase clostridium histolyticum 0.58 mg in the metacarpophalangeal (MP) joint cord
773508|NCT01498640|E1|Reported Event|XIAFLEX/XIAPEX|XIAFLEX/XIAPEX: up to three 0.58 mg injections
773509|NCT01498601|B3|Baseline|Total|Total of all reporting groups
773510|NCT01498601|B2|Baseline|Retrospective Study Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified through a retrospective chart review for the same in-patient unit.
773511|NCT01498601|B1|Baseline|Oral Care Treatment Group|Subjects were neurologically impaired, dependent adults who met inclusion criteria. Subjects were identified upon admission to the in-patient unit during the study period.
773512|NCT01498601|P2|Participant Flow|Oral Care Treatment Group|"All subjects in the intervention group received the enhanced oral care protocol:~Changing mouth suction equipment every 24 hours~Mouth assessment every 2-4 hours~Cleansing mouth with toothbrush every 12 hours~Cleansing oral mucosa with oral rinse solution every 2-4 hours~Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours~Suction mouth and throat as needed~Head of the bed elevated to a minimum of 30° during oral care"
773513|NCT01498601|P1|Participant Flow|Retrospective Study Group|A retrospective chart review identified matched in-patients meeting the study inclusion criteria.
773514|NCT01498601|O2|Outcome|Retrospective Study Group|Acute neurologically impaired adults in the retrospective chart review
773515|NCT01498601|O1|Outcome|Oral Care Treatment Group|Acute neurologically impaired adults receiving the study protocol
773516|NCT01498601|E2|Reported Event|Retrospective Study Group|Subjects were identified through a chart review process for in-patients on the study unit unit during the retrospective study period and met the inclusion criteria .
773517|NCT01498601|E1|Reported Event|Oral Care Treatment Group|Subjects meeting the inclusion criteria and identified at the point of admission to the in-patient unit during the study period.
773518|NCT01498588|B1|Baseline|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
773519|NCT01498588|P1|Participant Flow|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
773520|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
773521|NCT01498588|O1|Outcome|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
773522|NCT01498588|E1|Reported Event|Eribulin+Doxorubicin+Cyclophosphamide|"Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide~Eribulin Day 1 and Day 8 of a 21 day cycle x 4 cycles:~Day 1: Eribulin 1.4mg/m² IV~Day 8: Eribulin 1.4mg/m² IV~Dose-dense doxorubicin and cyclophosphamide every 14 days x 4 cycles:~Day 1: Doxorubicin 60mg/m² IV~Day 1: Cyclophosphamide 600mg/m² IV~Day 2: Pegfilgrastim support 6mg sc at least 24 hours after chemotherapy"
773523|NCT01498575|B3|Baseline|Total|Total of all reporting groups
773524|NCT01498575|B2|Baseline|Usual Practice|Use of typical supervised practice driving resources
773794|NCT01496469|P2|Participant Flow|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
773525|NCT01498575|B1|Baseline|Teen Driving Plan|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
773526|NCT01498575|P2|Participant Flow|Usual Practice (Control)|Use of typical supervised practice driving resources
776392|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
773527|NCT01498575|P1|Participant Flow|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
773528|NCT01498575|O2|Outcome|Usual Practice (Control)|Participants received a hard copy of the Pennsylvania driver's manual, also available online and at licensing centers.
773529|NCT01498575|O1|Outcome|Teen Driving Plan (TDP)|Access to web-based driving intervention that provides practice supervisors with specific guidance for facilitating supervision of teens' practice drives across several environments and conditions (eg., highways, commercial districts) using brief instructional videos and resources.
773530|NCT01498575|E2|Reported Event|Usual Practice (Control)|Use of typical supervised practice driving resources
773531|NCT01498575|E1|Reported Event|Teen Driving Plan (TDP)|"Access to web-based driving intervention~Teen driving plan: Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver."
773532|NCT01498549|B1|Baseline|Total Sample|This is the summary of the total sample used in the crossover design.
773533|NCT01498549|P1|Participant Flow|Participants|Participants were randomly assigned to one of 3 possible groups over a 3 day assessment period.
773534|NCT01498549|O3|Outcome|Sugar Pill 0mg|Sugar pill 0 mg dose
773535|NCT01498549|O2|Outcome|Atomoxetine 80 mg|Atomoxetine 80 mg dose
773536|NCT01498549|O1|Outcome|Atomoxetine 40 mg|Atomoxetine 40 mg dose
773537|NCT01498549|O3|Outcome|Sugar Pill 0mg|Sugar pill 0mg dose
773538|NCT01498549|O2|Outcome|Atomoxetine 80 mg|Atomoxetine 80 mg dose
773539|NCT01498549|O1|Outcome|Atomoxetine 40 mg|Atomoxetine 40 mg dose
773540|NCT01498549|E3|Reported Event|Sugar Pill 0 mg|Sugar pill 0 mg dose
773541|NCT01498549|E2|Reported Event|Atomoxetine 80 mg|Atomoxetine 80 mg dose
773542|NCT01498549|E1|Reported Event|Atomoxetine 40 mg|Atomoxetine 40 mg dose
773543|NCT01498458|B1|Baseline|Pazopanib Plus Capecitabine|pazopanib plus capecitabine
773544|NCT01498458|P1|Participant Flow|Pazopanib Plus Capecitabine|The baseline refers only to the 8 patients who received Pazopanib.
773545|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|2 patients were on study treatment for a long time.
773546|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|
773547|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|pazopanib together with capecitabine
773548|NCT01498458|O1|Outcome|Pazopanib + Capecitabine|Pazopanib and Capecitabine
773549|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|The following DLTs resulted in permanent discontinuation of the study therapy: hypertension, (DLT 1), mucositis CTC grade 3, hand-foot-syndrome CTC grade 3, increase of liver enzymes (GOT,- and GPT) CTC grade 2 (DLT 2), and increase of liver enzymes (GOT-, GPT) CTC grade 3 (DLT 3).
773550|NCT01498458|O1|Outcome|Pazopanib Plus Capecitabine|A maximal tolerated dose (MTD) could not be established. The study was stopped after 8 patients.
773551|NCT01498458|E1|Reported Event|Pazopanib Plus Capecitabine|There was only one arm in this study as this was a dose escalation study.
773552|NCT01498419|B5|Baseline|Total|Total of all reporting groups
773553|NCT01498419|B4|Baseline|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773554|NCT01498419|B3|Baseline|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773555|NCT01498419|B2|Baseline|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773556|NCT01498419|B1|Baseline|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773557|NCT01498419|P4|Participant Flow|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773558|NCT01498419|P3|Participant Flow|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773559|NCT01498419|P2|Participant Flow|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773560|NCT01498419|P1|Participant Flow|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773561|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773562|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773563|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773564|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773565|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773850|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773566|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773567|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773568|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773569|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773570|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773571|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773572|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773573|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773574|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773575|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773576|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773577|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773578|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773579|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773580|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773581|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773582|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773583|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773584|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773585|NCT01498419|O4|Outcome|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773586|NCT01498419|O3|Outcome|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773587|NCT01498419|O2|Outcome|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773588|NCT01498419|O1|Outcome|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773589|NCT01498419|E4|Reported Event|Multi Drug-Resistant: M (400 mg) Pa (200 mg) Z (1500 mg)|Multi Drug-Resistant Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773590|NCT01498419|E3|Reported Event|Drug Sensitive: Rifafour|Drug Sensitive Participants received Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: two tablets, 38-54kg: three tablets, 55-70kg: four tablets: 71kg and over: five tablets
773795|NCT01496469|P1|Participant Flow|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
776375|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
773591|NCT01498419|E2|Reported Event|Drug Sensitive: M (400 mg) Pa (200 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 200 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773592|NCT01498419|E1|Reported Event|Drug Sensitive: M (400 mg) Pa (100 mg) Z (1500 mg)|Drug Sensitive Participants received moxifloxacin (M) (one 400 mg tablet), pretomanid (Pa-824; Pa) (one 100 mg tablet), and pyrazinamide (Z) (three 500 mg tablets) once daily for 8 weeks
773593|NCT01498185|B6|Baseline|Total|Total of all reporting groups
773594|NCT01498185|B5|Baseline|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773595|NCT01498185|B4|Baseline|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773596|NCT01498185|B3|Baseline|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773597|NCT01498185|B2|Baseline|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773598|NCT01498185|B1|Baseline|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
773599|NCT01498185|P5|Participant Flow|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773600|NCT01498185|P4|Participant Flow|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773601|NCT01498185|P3|Participant Flow|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773602|NCT01498185|P2|Participant Flow|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773603|NCT01498185|P1|Participant Flow|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
773604|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773605|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773606|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773607|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773608|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773609|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773610|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773611|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773612|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773613|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773614|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773615|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773616|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773617|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773618|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773619|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773620|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773621|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773622|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773623|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773624|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773625|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773626|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773627|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773628|NCT01498185|O4|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773629|NCT01498185|O3|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773630|NCT01498185|O2|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773631|NCT01498185|O1|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773632|NCT01498185|O5|Outcome|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773633|NCT01498185|O4|Outcome|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773634|NCT01498185|O3|Outcome|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773635|NCT01498185|O2|Outcome|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773636|NCT01498185|O1|Outcome|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
773637|NCT01498185|E5|Reported Event|Dapagliflozin 10 mg + Insulin|Tablets, oral, once daily for 2 weeks
773638|NCT01498185|E4|Reported Event|Dapagliflozin 5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773639|NCT01498185|E3|Reported Event|Dapagliflozin 2.5 mg + Insulin|Tablets, oral, once daily for 2 weeks
773640|NCT01498185|E2|Reported Event|Dapagliflozin 1 mg + Insulin|Tablets, oral, once daily for 2 weeks
773641|NCT01498185|E1|Reported Event|Placebo + Insulin|Tablets, oral, once daily for 2 weeks
773642|NCT01498120|B1|Baseline|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
773643|NCT01498120|P1|Participant Flow|Rotigotine|Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
773644|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
773796|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
773691|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773645|NCT01498120|O1|Outcome|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
773646|NCT01498120|E1|Reported Event|Rotigotine (Safety Set)|The Safety Set (SS) which consists of all subjects who were randomized in this study and received at least 1 dose of study medication. Adolescent subjects who were previously administered rotigotine transdermal system (Neupro) in study SP1004 (NCT01495793), received the rotigotine transdermal patch in the following doses and sizes: 0.5mg/24h (2.5cm^2), 1mg/24h (5cm^2), 2mg/24h (10cm^2) and 3mg/24h (15cm^2).
773647|NCT01498068|B3|Baseline|Total|Total of all reporting groups
773648|NCT01498068|B2|Baseline|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773649|NCT01498068|B1|Baseline|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773650|NCT01498068|P2|Participant Flow|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773651|NCT01498068|P1|Participant Flow|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773652|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773653|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773654|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773655|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773656|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773657|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773658|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773659|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773660|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773661|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773662|NCT01498068|O2|Outcome|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773663|NCT01498068|O1|Outcome|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773664|NCT01498068|E2|Reported Event|Treatment-experienced|Treatment-experienced participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773665|NCT01498068|E1|Reported Event|Treatment-naïve|Treatment naïve participants received telaprevir 750 mg every 8 hours for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram once a week and RBV 1000 – 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration is based on participant’s prior treatment status, liver disease status, and individual on-treatment virologic response in this study.
773666|NCT01497938|B3|Baseline|Total|Total of all reporting groups
773667|NCT01497938|B2|Baseline|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
773668|NCT01497938|B1|Baseline|Low Glucose Suspend Feature (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
773669|NCT01497938|P2|Participant Flow|Control Arm|"The Low Glucose Suspend feature will not be available to subjects in the control arm~Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump : No Automatic suspension of insulin delivery when glucose is low."
773670|NCT01497938|P1|Participant Flow|Low Glucose Suspend Feasure (LGS)|"According to randomization, Low Glucose Suspend (LGS) will be turned ON in the treatment arm of the study~Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature : Automatic suspension of insulin delivery when glucose is low."
773671|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
773672|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
773673|NCT01497938|O2|Outcome|Group B Without Low Glucose Suspend (LGS) Feature|
773674|NCT01497938|O1|Outcome|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
773675|NCT01497938|E2|Reported Event|Group B Without Low Glucose Suspend (LGS) Feature|
773676|NCT01497938|E1|Reported Event|Group A With Low Glucose Suspend (LGS) Feature Turned 'ON'|
773677|NCT01497899|B5|Baseline|Total|Total of all reporting groups
773678|NCT01497899|B4|Baseline|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received DRV+COBI+TVD in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
773679|NCT01497899|B3|Baseline|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received D/C/F/TAF in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
773680|NCT01497899|B2|Baseline|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773681|NCT01497899|B1|Baseline|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773682|NCT01497899|P4|Participant Flow|DRV+COBI+TVD to Open-Label E/C/F/TAF|Participants previously received darunavir (DRV) + cobicistat (COBI) + truvada (TVD) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
773683|NCT01497899|P3|Participant Flow|D/C/F/TAF to Open-Label E/C/F/TAF|Participants previously received darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF) in another Gilead-sponsored study and then enrolled into the Open-Label Extension Phase of this study to receive E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily.
773684|NCT01497899|P2|Participant Flow|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773685|NCT01497899|P1|Participant Flow|E/C/F/TAF|"Double-Blind Phase: Elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (Genvoya®; E/C/F/TAF) (150/150/200/10 mg) fixed-dose combination (FDC) tablet plus elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773686|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773687|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773688|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773689|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773690|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773797|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
773692|NCT01497899|O2|Outcome|E/C/F/TDF|"Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks~Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773693|NCT01497899|O1|Outcome|E/C/F/TAF|"Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks~Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773694|NCT01497899|E3|Reported Event|All E/C/F/TAF|"Adverse events in this reporting group include those that occurred any time during the study by participants while receiving E/C/F/TAF.~Participants received blinded or open-label E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773695|NCT01497899|E2|Reported Event|E/C/F/TDF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TDF.~Double-Blind Phase: E/C/F/TDF (150/150/200/300 mg) FDC tablet plus E/C/F/TAF placebo tablet administered orally once daily for 48 weeks; Open-Label Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773696|NCT01497899|E1|Reported Event|E/C/F/TAF|"Adverse events in this reporting group include those that occurred during the double-blind phase by participants randomized to E/C/F/TAF.~Double-Blind Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet plus E/C/F/TDF placebo tablet administered orally once daily for 48 weeks; Open-Label (OL) Extension Phase: E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily"
773697|NCT01497756|B1|Baseline|CAPP Application|Patients in whom device is used
773698|NCT01497756|P1|Participant Flow|CAPP Application|Patients in whom device is used
773699|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
773700|NCT01497756|O1|Outcome|CAPP Application|Patients in whom device is used
773701|NCT01497756|E1|Reported Event|CAPP Application|Patients in whom device is used
773702|NCT01497665|B1|Baseline|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773703|NCT01497665|P1|Participant Flow|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773704|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773705|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773706|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773707|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773708|NCT01497665|O1|Outcome|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773709|NCT01497665|E1|Reported Event|GRN1005 Alone|"GRN1005 alone~GRN1005: 650 mg/m2 IV every 3 weeks"
773710|NCT01497366|B3|Baseline|Total|Total of all reporting groups
773711|NCT01497366|B2|Baseline|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773712|NCT01497366|B1|Baseline|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
773713|NCT01497366|P2|Participant Flow|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773714|NCT01497366|P1|Participant Flow|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+ribavirin (RBV) for 12 weeks.
773715|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773716|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
773717|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773718|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
773719|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773720|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
773721|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773722|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir (SOF)+RBV for 12 weeks.
773723|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773724|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
773725|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773726|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
773727|NCT01497366|O2|Outcome|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773728|NCT01497366|O1|Outcome|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
773729|NCT01497366|E2|Reported Event|PEG+RBV|Participants were randomized to receive PEG+RBV for 24 weeks.
773730|NCT01497366|E1|Reported Event|Sofosbuvir+RBV|Participants were randomized to receive sofosbuvir+RBV for 12 weeks.
773731|NCT01497275|B1|Baseline|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
773732|NCT01497275|P1|Participant Flow|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
773798|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
773799|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
773847|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773848|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773733|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
773734|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
773735|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
773736|NCT01497275|O1|Outcome|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
773737|NCT01497275|E1|Reported Event|Zevalin + Velcade|Drug: Rituximab, Bortezomib,Y90 ibritumomab tiuxetan Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4 millicurie (mCi)/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
773738|NCT01497262|B1|Baseline|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
773739|NCT01497262|P1|Participant Flow|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
773740|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
773741|NCT01497262|O1|Outcome|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
773742|NCT01497262|E1|Reported Event|Fingolimod 0.5 mg|Open-label fingolimod 0.5 mg, taken orally once daily for 4 months
773743|NCT01497197|B3|Baseline|Total|Total of all reporting groups
773744|NCT01497197|B2|Baseline|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773745|NCT01497197|B1|Baseline|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773746|NCT01497197|P2|Participant Flow|Gonal-f® Followed by Luveris|GONAL-f® (Liquid Pen; 300 IU per day) stimulation Day 1-5 then added Luveris® (vial/powder, 150 IU per day) from stimulation day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
773747|NCT01497197|P1|Participant Flow|Gonal-f®+Luveris|GONAL f® (Liquid Pen; 300 international units [IU] of per day) stimulation Day 1-5 then followed by Luveris® (vial/powder, 150 IU per day) from stimulation Day 1 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject’s ovarian response and according to the centre's standard practice.
773748|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773749|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773750|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773751|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773800|NCT01496469|O2|Outcome|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
773801|NCT01496469|O1|Outcome|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
773752|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773753|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773754|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773755|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773756|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773757|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773758|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773759|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773760|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773761|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773762|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773763|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773764|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773765|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773766|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773802|NCT01496469|E2|Reported Event|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
773803|NCT01496469|E1|Reported Event|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
791998|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
773767|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773768|NCT01497197|O2|Outcome|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773769|NCT01497197|O1|Outcome|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773770|NCT01497197|E2|Reported Event|Gonal-f® Followed by Luveris|GONAL-f® 300 IU per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 6 until required r-hCG level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773771|NCT01497197|E1|Reported Event|Gonal-f®+Luveris|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen from stimulation Day 1-5 followed by Luveris® 150 IU per day lyophilized powder for subcutaneous injection from stimulation Day 1 until required recombinant human chorionic gonadotropin (r-hCG) level was met. The dose was adjusted from stimulation Day 6 (increased or decreased) based upon the subject's ovarian response and according to the center's standard practice.
773772|NCT01497171|B3|Baseline|Total|Total of all reporting groups
773773|NCT01497171|B2|Baseline|Anterior Colporrhaphy|Traditional suture repair of anterior vaginal prolapse
773774|NCT01497171|B1|Baseline|Elevate Mesh|Transvaginal mesh repair of anterior vaginal prolapse
773775|NCT01497171|P2|Participant Flow|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
773776|NCT01497171|P1|Participant Flow|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
773777|NCT01497171|O2|Outcome|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
773778|NCT01497171|O1|Outcome|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
773779|NCT01497171|E2|Reported Event|Anterior Colporrhaphy|"Anterior colporrhaphy - surgical repair of prolapse~Anterior Colporrhaphy: Traditional suture repair of anterior vaginal prolapse"
773780|NCT01497171|E1|Reported Event|Elevate Mesh|"Elevate transvaginal mesh - surgical repair of prolapse~Elevate Mesh: Transvaginal mesh repair of anterior vaginal prolapse"
773781|NCT01496807|B1|Baseline|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773782|NCT01496807|P1|Participant Flow|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773783|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773784|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773785|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773786|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773787|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773788|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773789|NCT01496807|O1|Outcome|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773790|NCT01496807|E1|Reported Event|Yervoy With Sylatron|Participants are given Yervoy induction every 3 weeks for four doses, for 12 weeks, and all participants simultaneously receive Sylatron induction weekly, followed by Sylatron maintenance alone for up to 144 additional weeks (total 156 weeks = 3 years).
773791|NCT01496469|B3|Baseline|Total|Total of all reporting groups
773792|NCT01496469|B2|Baseline|Febuxostat 80 mg|Febuxostat 80 mg, over-encapsulated tablet, orally, once daily for up to 6 week.
773793|NCT01496469|B1|Baseline|Placebo|Febuxostat placebo-matching over-encapsulated tablet, orally, once daily for up to 6 weeks.
791999|NCT01433263|O1|Outcome|30mg/kg BYM338|
773804|NCT01496456|B1|Baseline|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms in same patient (2 study teeth). A) Resin infiltration therapy in addition to preventative caries management B) Preventative caries management only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC fluoride supplements"
773805|NCT01496456|P1|Participant Flow|Lesion Infiltration and Preventative Management Only|"Paired split-mouth study: both arms (arm A and arm B) were applied in same patient (2 study teeth).~A) Resin infiltration therapy in addition to SOC Preventative caries management B) SOC Preventative caries management only.~––– Standard Of Care (SOC) Baseline preventative caries management included dietary and behavioral modification, and over-the-counter (OTC) fluoride supplements."
773806|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation~Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
773807|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
773808|NCT01496456|O2|Outcome|Preventative Measures|"Caries management by preventative measures only: oral hygiene instruction, diet counseling and fluoride supplementation~Baseline SOC preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
773809|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
773810|NCT01496456|O2|Outcome|Preventative Measures|SOC Caries management by preventative measures only.
773811|NCT01496456|O1|Outcome|Lesion Infiltration|Resin infiltration of caries lesion in addition to SOC caries management by preventative measures.
773812|NCT01496456|E2|Reported Event|Preventative Measures|"Caries management by preventative measures only~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
773813|NCT01496456|E1|Reported Event|Lesion Infiltration|"Resin infiltration of caries lesion in addition to SOC caries management by preventative measures~SOC Baseline preventative caries management: dietary and behavioral modification, and OTC-fluoride supplements"
773814|NCT01496430|B4|Baseline|Total|Total of all reporting groups
773815|NCT01496430|B3|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773816|NCT01496430|B2|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773817|NCT01496430|B1|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773818|NCT01496430|P3|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773819|NCT01496430|P2|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773820|NCT01496430|P1|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773821|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773822|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773823|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773824|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773825|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773826|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773827|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773828|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773829|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773830|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773831|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773832|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773833|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773834|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773835|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773836|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773837|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773838|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773839|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773840|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773841|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773842|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773843|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773844|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773845|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773846|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
792000|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
773851|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773852|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773853|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773854|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773855|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773856|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773857|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773858|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773859|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773860|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773861|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773862|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773863|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773864|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773865|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773866|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773867|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773868|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773869|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773870|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773871|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773872|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773873|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773874|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773875|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773876|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773877|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773878|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773879|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773880|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773881|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773882|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773883|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773884|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773885|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773886|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773887|NCT01496430|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773888|NCT01496430|O2|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773889|NCT01496430|O1|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773890|NCT01496430|E3|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 24 weeks.
773891|NCT01496430|E2|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 24 weeks.
773892|NCT01496430|E1|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 24 weeks.
773893|NCT01496352|B3|Baseline|Total|Total of all reporting groups
773894|NCT01496352|B2|Baseline|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
773895|NCT01496352|B1|Baseline|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
773896|NCT01496352|P2|Participant Flow|DFA-02 Placebo|Progressive cohorts of 2 patients per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
792001|NCT01433263|O1|Outcome|30mg/kg BYM338|
773897|NCT01496352|P1|Participant Flow|DFA-02|"Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02~DFA-02: Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure"
773898|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
773899|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL DFA-02
773900|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subject per cohort receiving up to 10, 20 or 30 mL DFA-02 placebo
773901|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
773902|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving 10, 20 or 30 mL DFA-02 placebo
773903|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL DFA-02
773904|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 and 30 mL of DFA-02 placebo
773905|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 18 subjects receiving up to 10, 20 or 30 mL of DFA-02
773906|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
773907|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
773908|NCT01496352|O2|Outcome|DFA-02 Placebo|Progressive cohorts of 2 subjects receiving 10, 20 or 30 mL of DFA-02 placebo
773909|NCT01496352|O1|Outcome|DFA-02|Progressive cohorts of 8 subjects receiving up to 10, 20 or 30 mL of DFA-02
773910|NCT01496352|E2|Reported Event|DFA-02 Placebo|Progressive cohorts of 2 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02 placebo
773911|NCT01496352|E1|Reported Event|DFA-02|Progressive cohorts of 8 subjects per cohort receiving up to 10, 20 or 30 mL of DFA-02
773912|NCT01496313|B3|Baseline|Total|Total of all reporting groups
773913|NCT01496313|B2|Baseline|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773914|NCT01496313|B1|Baseline|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773915|NCT01496313|P2|Participant Flow|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773916|NCT01496313|P1|Participant Flow|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773917|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773918|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773919|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773920|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773921|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773922|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773923|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773924|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773925|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773926|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773927|NCT01496313|O2|Outcome|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773928|NCT01496313|O1|Outcome|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773929|NCT01496313|E2|Reported Event|Vandetanib 300 mg|Oral blinded tablet, taken once daily
773930|NCT01496313|E1|Reported Event|Vandetanib 150 mg|Oral blinded tablet, taken once daily
773931|NCT01496287|B1|Baseline|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
773932|NCT01496287|P1|Participant Flow|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
773933|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
773934|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
773935|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
773936|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
773937|NCT01496287|O1|Outcome|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
773938|NCT01496287|E1|Reported Event|Tube Placement Group|Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
773939|NCT01496274|B3|Baseline|Total|Total of all reporting groups
773940|NCT01496274|B2|Baseline|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
773941|NCT01496274|B1|Baseline|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention.~rIX-FP: Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration"
773971|NCT01496274|O1|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
792002|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
773942|NCT01496274|P2|Participant Flow|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
774047|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
776393|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
773943|NCT01496274|P1|Participant Flow|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773944|NCT01496274|O3|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
773945|NCT01496274|O2|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
773946|NCT01496274|O1|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
773947|NCT01496274|O1|Outcome|Surgical Population|The Surgical population consisted of 3 subjects in the prophylaxis arm and 1 subject in the on demand arm who received at least 1 dose of rIX FP for a major or minor surgical procedure.
773948|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773949|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773950|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773951|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773952|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773953|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773954|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773955|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773956|NCT01496274|O4|Outcome|Prophylaxis Arm, 14-day Regimen|Subjects received prophylactic rIX-FP every 14 days.
773957|NCT01496274|O3|Outcome|Prophylaxis Arm, 10-day Regimen|Subjects received prophylactic rIX-FP every 10 days.
773958|NCT01496274|O2|Outcome|Prophylaxis Arm, 7-day Regimen|Subjects received prophylactic rIX-FP on a weekly basis.
773959|NCT01496274|O1|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
773960|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773961|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773962|NCT01496274|O3|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
773963|NCT01496274|O2|Outcome|On-demand Arm, On-demand Regimen|Participants in the On-demand Arm, when receiving episodic treatment for bleeding episodes (on-demand regimen).
773964|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773965|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
773966|NCT01496274|O3|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
773967|NCT01496274|O2|Outcome|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773968|NCT01496274|O1|Outcome|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773969|NCT01496274|O1|Outcome|Safety Population|The Safety population consisted of subjects who received at least 1 dose of rIX-FP during the study.
773970|NCT01496274|O2|Outcome|On-demand Arm, Prophylaxis Regimen|Participants in the On-demand Arm, when receiving routine weekly prophylaxis (prophylaxis regimen).
773972|NCT01496274|E2|Reported Event|On-demand|"Episodic treatment for bleeding episodes for up to 26 weeks then switch to routine weekly prophylaxis for the remainder of the study.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773973|NCT01496274|E1|Reported Event|Prophylaxis|"Routine weekly prophylaxis and episodic treatment for bleeding episodes. An individualized dosing interval may be tested in sub-group subjects during the 2nd part of the trial.~Subjects may participate in a surgical ’sub-study’ in which rIX-FP may be administered prior to, during and after surgical intervention."
773974|NCT01496248|B1|Baseline|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773975|NCT01496248|P1|Participant Flow|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773976|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773977|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773978|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773979|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773980|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773981|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773982|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773983|NCT01496248|O1|Outcome|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773984|NCT01496248|E1|Reported Event|Korean Red Ginseng|Korean Red Ginseng: 100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
773985|NCT01496183|B3|Baseline|Total|Total of all reporting groups
773986|NCT01496183|B2|Baseline|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
773987|NCT01496183|B1|Baseline|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
773988|NCT01496183|P2|Participant Flow|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
773989|NCT01496183|P1|Participant Flow|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
773990|NCT01496183|O2|Outcome|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
773991|NCT01496183|O1|Outcome|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days Six subjects from the placebo group completed the 2-week double-blind trial and were included in the analysis.
773992|NCT01496183|E2|Reported Event|Olanzapine|Olanzapine: Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
773993|NCT01496183|E1|Reported Event|Placebo|Placebo: Placebo capsule administered orally at bedtime for 14 days
773994|NCT01495975|B3|Baseline|Total|Total of all reporting groups
773995|NCT01495975|B2|Baseline|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
773996|NCT01495975|B1|Baseline|Usual Care|Usual care for diabetes in the 1 month after discharge.
773997|NCT01495975|P2|Participant Flow|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
773998|NCT01495975|P1|Participant Flow|Usual Care|Usual care for diabetes in the 1 month after discharge.
773999|NCT01495975|O2|Outcome|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
774000|NCT01495975|O1|Outcome|Usual Care|Usual care for diabetes in the 1 month after discharge.
774045|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774048|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
776394|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
774001|NCT01495975|E2|Reported Event|Diabetes Transitions Tool Kit|"Remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), in the 1 month after discharge.~Diabetes Transitions Tool Kit: Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge."
774002|NCT01495975|E1|Reported Event|Usual Care|Usual care for diabetes in the 1 month after discharge.
774003|NCT01495923|B3|Baseline|Total|Total of all reporting groups
774004|NCT01495923|B2|Baseline|Gabapentin|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive real gabapentin and a placebo injection as treatment.
774005|NCT01495923|B1|Baseline|Epidural Steriod Injections|Participants that had lumbosacral radicular pain secondary to herniated disc or spinal stenosis who receive a real epidural steroid injection and placebo medication as treatment.
774006|NCT01495923|P2|Participant Flow|Gabapentin|If randomized to this group participants received gabapentin medication and a placebo intramuscular injection. The gabapentin was uptitrated to a therapeutic dose using a titration schedule.
774007|NCT01495923|P1|Participant Flow|Epidural Steroid Injection|If randomized to this group, participants received either a transforaminal injection for unilateral pain or an interlaminar injection for bilateral pain and placebo medication. The level and type of injection to be given was determined by signs, symptoms, and radiological findings.
774008|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774009|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774010|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774011|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774012|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774013|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774014|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774015|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774016|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774017|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774018|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774019|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774020|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774021|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774022|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774023|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774024|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774025|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774026|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774027|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774028|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774029|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774030|NCT01495923|O2|Outcome|Epidural Steroid|This group received an epidural steroid injection and placebo gabapentin.
774031|NCT01495923|O1|Outcome|Gabapentin Group|This group received gabapentin and a placebo intramuscular injection.
774032|NCT01495923|O2|Outcome|Gabapentin|This group received gabapentin medication and a placebo injection.
774033|NCT01495923|O1|Outcome|Epidural Steroid Injection|This group received an epidural steroid injection and placebo medication.
774034|NCT01495923|E2|Reported Event|Gabapentin|"Titration of gabapentin to effect~Sham epidural steroid injection: Injection of saline into the back muscles~Gabapentin: Titration of gabapentin to effect"
774035|NCT01495923|E1|Reported Event|Epidural Steroids|"Injection of steroids into the epidural space~epidural steroid injection: Injection of steroids and local anesthetic into the epidural space~Placebo gabapentin: Titration of placebo gabapentin"
774036|NCT01495858|B4|Baseline|Total|Total of all reporting groups
774037|NCT01495858|B3|Baseline|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774038|NCT01495858|B2|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774039|NCT01495858|B1|Baseline|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774040|NCT01495858|P3|Participant Flow|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774041|NCT01495858|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774042|NCT01495858|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774043|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774044|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774046|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
792003|NCT01433263|O1|Outcome|30mg/kg BYM338|
774049|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774050|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774051|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774052|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774053|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774054|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774055|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774056|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774057|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774058|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774059|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774060|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774061|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774062|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774063|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774064|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774065|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774066|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774067|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774068|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774069|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774070|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774071|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774072|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774073|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774074|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774075|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774076|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774077|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774078|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774079|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774080|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774081|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774082|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774083|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774084|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774085|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
792004|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
774086|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774087|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774088|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774089|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774090|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774091|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774092|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774093|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774094|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774095|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774096|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774097|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774098|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774099|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774100|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774101|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774102|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774103|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774104|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774105|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774106|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774107|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774108|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774109|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774110|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774111|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774112|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774113|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774114|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774115|NCT01495858|O3|Outcome|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774116|NCT01495858|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
774117|NCT01495858|O1|Outcome|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
774118|NCT01495858|E3|Reported Event|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
774119|NCT01495858|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally
774120|NCT01495858|E1|Reported Event|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally
774121|NCT01495793|B1|Baseline|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774122|NCT01495793|P1|Participant Flow|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774123|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774124|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774125|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774126|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774127|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774128|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774129|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774130|NCT01495793|O1|Outcome|Rotigotine (PKPPS)|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774131|NCT01495793|E1|Reported Event|Rotigotine|In the Titration Period a subject received the first dose of rotigotine then the dose was increased weekly by a dose step over 4 weeks.
774132|NCT01495702|B3|Baseline|Total|Total of all reporting groups
774133|NCT01495702|B2|Baseline|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
774134|NCT01495702|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
774135|NCT01495702|P2|Participant Flow|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an nonnucleoside reverse transcriptase inhibitor (NNRTI) (efavirenz (EFV), nevirapine (NVP), or rilpivirine (RPV)) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
774136|NCT01495702|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
774137|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
774138|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
774139|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
774140|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
774141|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
774142|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
774143|NCT01495702|O2|Outcome|NNRTI+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
774144|NCT01495702|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
774145|NCT01495702|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in all participants while receiving Stribild in the randomized and extension phases.
774146|NCT01495702|E2|Reported Event|NNRTI+FTC/TDF (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving NNRTI+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of an NNRTI (EFV, NVP, or RPV) plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
774147|NCT01495702|E1|Reported Event|Stribild (Randomized Phase)|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
774148|NCT01495689|B3|Baseline|Total|Total of all reporting groups
774149|NCT01495689|B2|Baseline|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
774150|NCT01495689|B1|Baseline|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
774729|NCT01494467|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
774151|NCT01495689|P2|Participant Flow|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
774152|NCT01495689|P1|Participant Flow|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
774153|NCT01495689|O2|Outcome|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
774154|NCT01495689|O1|Outcome|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
774155|NCT01495689|E2|Reported Event|Ottawa Model With SmartCard|"On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids~Ottawa Model with SmartCard: On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids"
774156|NCT01495689|E1|Reported Event|Usual Care|"Usual care for smoking cessation will be delivered to the control arm which comprises of strong physician advice, brief counseling from the clinic nurse +/- a prescription for smoking cessation aid if requested and willing~Usual care: Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing"
774157|NCT01495585|B4|Baseline|Total|Total of all reporting groups
774158|NCT01495585|B3|Baseline|Lonafarnib 200 mg|"4 participants were randomized to Lonafarnib 200 mg and two Placebo participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg ."
774159|NCT01495585|B2|Baseline|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
774160|NCT01495585|B1|Baseline|Placebo|placebo control.
774161|NCT01495585|P3|Participant Flow|Lonafarnib 200 mg|4 participants were randomized to Lonafarnib 200 mg.
774162|NCT01495585|P2|Participant Flow|Lonafarnib 100 mg|6 participants were randomized to Lonafarnib 100 mg.
774163|NCT01495585|P1|Participant Flow|Placebo|Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
774164|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
774165|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
774166|NCT01495585|O1|Outcome|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
774167|NCT01495585|O3|Outcome|Group 2|lonafarnib 200 mg
774168|NCT01495585|O2|Outcome|Group 1|lonafarnib 100 mg
774169|NCT01495585|O1|Outcome|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
774170|NCT01495585|E3|Reported Event|Group 2|lonafarnib 200 mg
774171|NCT01495585|E2|Reported Event|Group 1|lonafarnib 100 mg
774172|NCT01495585|E1|Reported Event|Placebo|"placebo control.~Group 1 placebo participants received open-label lonafarnib as group 2 participants.~Each group consisted of 8 participants (6 lonafarnib ands 2 placebo)."
774173|NCT01495572|B3|Baseline|Total|Total of all reporting groups
774174|NCT01495572|B2|Baseline|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774175|NCT01495572|B1|Baseline|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774176|NCT01495572|P2|Participant Flow|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774177|NCT01495572|P1|Participant Flow|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774212|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774178|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x1011 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774179|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774180|NCT01495572|O2|Outcome|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774181|NCT01495572|O1|Outcome|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x10^11 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774182|NCT01495572|E2|Reported Event|Peripheral Blood Lymphocytes (PBL)|"Cyclophosphamide 60 mg/kg intravenous (IV ) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus MART-127-35 reactive CD8+ PBL up to 3x10^11 IV over 20-30 minutes on day 0~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days(day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774183|NCT01495572|E1|Reported Event|High Dose (HD) Aldesleukin|"Pts receiving high dose aldesleukin: Cyclophosphamide 60 mg/kg intravenous (IV) for days -7 and -6, Fludarabine 25 mg/m^2 IV for days -5 to -1, plus melanoma antigen recognized by T cells (MART)-127-35 reactive CD8+ peripheral blood lymphocytes (PBL) up to 3x1011 IV over 20-30 minutes on day 0, plus aldesleukin 720,000 IU/kg IV over 15 minutes, every 8 hrs for up to 5 days.~Fludarabine: 25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)~Cyclophosphamide: 60 mg/kg IV (in the vein) for days -7 and -6~Aldesleukin: Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg IV over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6~MART-1 Reactive CD8+ PBL: IV over 30 minutes on day 0"
774184|NCT01495481|B1|Baseline|Adenosine and Dexmedetomidine|Patients will receive both adenosine and dexmedetomidine for the termination of SVT.
774185|NCT01495481|P1|Participant Flow|Adenosine and Dexmedetomidine|Patients will receive adenosine for termination of SVT, and then dexmedetomidine for the termination of supraventricular tachycardia (SVT) and comparison will be made for efficacy and safety.
774186|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
774187|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push"
774188|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
774189|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
774190|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
774191|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of supraventricular tachycardia (SVT)~Dexmedetomidine: Dexmedetomidine 2 mcg/kg, Intravenous push"
774192|NCT01495481|O2|Outcome|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
774193|NCT01495481|O1|Outcome|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
774194|NCT01495481|E2|Reported Event|Adenosine|"Patients will receive Adenosine for the termination of SVT~Adenosine: stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful"
774195|NCT01495481|E1|Reported Event|Dexmedetomidine|"Patients will receive dexmedetomidine for the termination of SVT~Dexmedetomidine: Dexmedetomidine 1 mcg/kg, Intravenous push"
774196|NCT01495286|B1|Baseline|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774213|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774784|NCT01493557|B3|Baseline|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
774214|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774197|NCT01495286|P1|Participant Flow|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774198|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774199|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774200|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774201|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774202|NCT01495286|O1|Outcome|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774203|NCT01495286|E1|Reported Event|Noninvasive Electrical Stimulation Acupuncture Points (NESAP)|This was a single arm study, a descriptive pilot study to assess the safety of using noninvasive electrical stimulation at acupuncture points (NESAP) as an analgesic during routine heel sticks for newborn screenings. All infants who participated in the study received NESAP starting 10 minutes before the heel stick. The treatment continued throughout the heel stick and for 5 minutes afterwards. The first 6 infants received NESAP with an Empi Select transcutaneous electrical nerve stimulation (TENS) unit at 1.0 mA, 2 Hz. THe second 6 infants received TENS unit stimulation at 2.0 mA, 10 Hz. The last 18 infants received TENS unit stimulation at 3.5 mA, 10 Hz.
774204|NCT01495000|B3|Baseline|Total|Total of all reporting groups
774205|NCT01495000|B2|Baseline|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774206|NCT01495000|B1|Baseline|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774207|NCT01495000|P2|Participant Flow|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774208|NCT01495000|P1|Participant Flow|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774209|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774210|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774211|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774215|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774216|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774217|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774218|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774219|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774220|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774221|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774222|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774223|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774224|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774225|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774226|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774227|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774228|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774229|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774230|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774231|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774232|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774233|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774234|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774235|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774236|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774237|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
817966|NCT01333592|E1|Reported Event|KAD-1229 / DPP-4 Inhibitors|
774238|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774239|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774240|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774241|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774242|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774243|NCT01495000|O2|Outcome|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774244|NCT01495000|O1|Outcome|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774245|NCT01495000|E2|Reported Event|Placebo|Participants received placebo administered as a single subcutaneous injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
774246|NCT01495000|E1|Reported Event|Denosumab 60 mg|Participants received denosumab 60 milligrams (mg) administered as a single subcutaneous (SC) injection at the start of the Double-blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 international units [IU]).
774247|NCT01494987|B3|Baseline|Total|Total of all reporting groups
774248|NCT01494987|B2|Baseline|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
774249|NCT01494987|B1|Baseline|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
774250|NCT01494987|P2|Participant Flow|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
774251|NCT01494987|P1|Participant Flow|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
774252|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
774266|NCT01494818|P1|Participant Flow|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774864|NCT01493089|O1|Outcome|Zegerid Group|
774268|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
776310|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
774253|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
774254|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
774255|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
774256|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
774257|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
774258|NCT01494987|O2|Outcome|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
774259|NCT01494987|O1|Outcome|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
774260|NCT01494987|E2|Reported Event|Ranolazine+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive ranolazine (1 x 500 mg tablet) twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg (2 x 500 mg tablets) twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24.~Participants were required to maintain their diet and exercise regimen."
774261|NCT01494987|E1|Reported Event|Placebo+Glimepiride|"Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride received glimepiride 2 mg once daily, and if tolerated the dose was increased on Day 8 (+ 2 days) to 4 mg once daily.~Qualifying period: participants received placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria continued to the treatment period.~Treatment period: participants were randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks.~Participants were required to maintain their diet and exercise regimen."
774262|NCT01494818|B3|Baseline|Total|Total of all reporting groups
774263|NCT01494818|B2|Baseline|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774264|NCT01494818|B1|Baseline|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774265|NCT01494818|P2|Participant Flow|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774267|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774269|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774270|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774271|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774272|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774273|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774274|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774275|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774276|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774277|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774278|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774279|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774280|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774281|NCT01494818|O2|Outcome|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774282|NCT01494818|O1|Outcome|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774283|NCT01494818|E2|Reported Event|ReNu MultiPlus|PHMB-containing contact lens solution used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774284|NCT01494818|E1|Reported Event|CLEAR CARE/AOSEPT Plus|Hydrogen peroxide-based contact lens care system used with silicone hydrogel contact lenses per manufacturer's instructions for 3 months
774285|NCT01494753|B3|Baseline|Total|Total of all reporting groups
774286|NCT01494753|B2|Baseline|T2345/Prostaglandin|One drop at 8.00pm.
774287|NCT01494753|B1|Baseline|Prostaglandin/T2345|One drop at 8.00pm.
774288|NCT01494753|P2|Participant Flow|T2345/Prostaglandin|One drop at 8.00pm.
774289|NCT01494753|P1|Participant Flow|Prostaglandin/T2345|One drop at 8.00pm.
774290|NCT01494753|O2|Outcome|T2345/Prostaglandin|One drop at 8.00pm.
774291|NCT01494753|O1|Outcome|Prostaglandin/T2345|One drop at 8.00pm.
774292|NCT01494753|E2|Reported Event|T2345|One drop at 8.00pm.
774293|NCT01494753|E1|Reported Event|Prostaglandin|One drop at 8.00pm.
774294|NCT01494649|B3|Baseline|Total|Total of all reporting groups
774295|NCT01494649|B2|Baseline|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774296|NCT01494649|B1|Baseline|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
774297|NCT01494649|P2|Participant Flow|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774298|NCT01494649|P1|Participant Flow|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily.
774299|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774300|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
774301|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774302|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
774303|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774304|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
774305|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774306|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeths for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
792005|NCT01433263|O1|Outcome|30mg/kg BYM338|
774307|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774308|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
774309|NCT01494649|O2|Outcome|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily.
774310|NCT01494649|O1|Outcome|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute for 14 days twice daily. The test product is a commercially available product.
774311|NCT01494649|E2|Reported Event|Negative Control|Toothpaste containing 0.76% sodium monofluorophosphate, 1 inch strip brushed on all teeth in the whole mouth for at least 1 minute for 14 days twice daily
774312|NCT01494649|E1|Reported Event|Test|Commercially available toothpaste containing 0.454% stannous fluoride, 1 inch strip brushed on each of the 2 selected sensitive teeth for 30 seconds, followed by thorough brushing of all teeth for at least 1 minute, for 14 days twice daily. The test product is a commercially available product.
774313|NCT01494610|B1|Baseline|FP/Salmeterol 250/50 Mcg|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in one of two sequences in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively: ABBA, BAAB. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
774314|NCT01494610|P2|Participant Flow|FP/Salmeterol 250/50 Mcg: Sequence BAAB|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of BAAB in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
774315|NCT01494610|P1|Participant Flow|FP/Salmeterol 250/50 Mcg: Sequence ABBA|Participants received fluticasone propionate (FP)/salmeterol 250/50 micrograms (mcg) twice daily via a capsule-based inhaler for two 10-day periods and via a multi-dose dry powder (MDPI) inhaler for two 10-day periods in a replicate crossover design. Participants were dosed approximately every 12 hours. Treatment was given in the sequence of ABBA in Periods 1, 2, 3, and 4 (with no washouts between periods), respectively. A, FP/salmeterol from an MDPI; B, FP/salmeterol from a capsule-based inhaler.
774316|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774317|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774318|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774319|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774320|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774321|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774322|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774323|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774324|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774325|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774326|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774327|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774328|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774329|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774330|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774865|NCT01493089|O2|Outcome|Losec Group|20mg Losec over-encapsulated capsule plus placebo suspension
774866|NCT01493089|O1|Outcome|Zegerid Group|20mg Zegerid suspension plus over-encapsulated placebo capsule
774949|NCT01492400|E1|Reported Event|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
774331|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774332|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774333|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774334|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774335|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774336|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774337|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774338|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774339|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774340|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774341|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774342|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774343|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774344|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774345|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774346|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774347|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774348|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774349|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774350|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774351|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774352|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774353|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774354|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774355|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774356|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774357|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774358|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774867|NCT01493089|E2|Reported Event|Losec|Treatment of heartburn with Losec
774868|NCT01493089|E1|Reported Event|Zegerid|Treatment of heartburn with Zegerid
774359|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774360|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774361|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774362|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774363|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774364|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774365|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774366|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774367|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774368|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774369|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774370|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774371|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774372|NCT01494610|O2|Outcome|FP/Salmeterol From Capsule-based Inhaler|Fluticasone propionate/salmeterol combination was administered as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for two 10-day periods.
774373|NCT01494610|O1|Outcome|FP/Salmeterol From MDPI|Fluticasone propionate (FP)/salmeterol combination was administered as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for two 10-day periods
774374|NCT01494610|E8|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
774375|NCT01494610|E7|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
774376|NCT01494610|E6|Reported Event|FP/Salmeterol From MDPI 2nd Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
774377|NCT01494610|E5|Reported Event|FP/Salmeterol From MDPI 1st Admin, COPD|Fluticasone propionate (FP)/salmeterol combination was administered to participants with COPD as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
774378|NCT01494610|E4|Reported Event|FP/Salmeterol From Capsule-based Inhaler 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
774379|NCT01494610|E3|Reported Event|FP/Salmeterol From Capsule-based Inhaler 1st Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in capsule in the dose of 250/50 mcg BID via a capsule-based inhaler for a 10-day period.
774380|NCT01494610|E2|Reported Event|FP/Salmeterol From MDPI 2nd Admin, Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to particiapants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
774381|NCT01494610|E1|Reported Event|FP/Salmeterol From MDPI 1st Administration (Admin), Asthma|Fluticasone propionate (FP)/salmeterol combination was administered to participants with asthma as a powder in blister in the dose of 250/50 micrograms (mcg) twice daily (BID) via a multi-dose dry powder inhaler (MDPI) for a 10-day period.
774382|NCT01494584|B1|Baseline|Ezogabine/Retigabine|Participants received an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774395|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774869|NCT01492439|B3|Baseline|Total|Total of all reporting groups
774383|NCT01494584|P1|Participant Flow|Ezogabine/Retigabine|Participants recieved an initial dose of ezogabine/retigabine 300 milligrams (mg) per day administered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774384|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774385|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774386|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774387|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774388|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774389|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774390|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774391|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774392|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774393|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774394|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774730|NCT01494350|B1|Baseline|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
774396|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774397|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774398|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774399|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774400|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774401|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774402|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774403|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774404|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774405|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774406|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R)300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774407|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774731|NCT01494350|P1|Participant Flow|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
774408|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774409|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly upitration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774410|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774411|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774412|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774413|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants recieved an initial dose of ezogabine/retigabine 300 mg/day administered as 100 mg IR tablets TID orally and underwent weekly up-titration at Weeks 1, 3, and 5. Dose titration occurred no more than once per week, with participants receiving up-titrated daily doses of 450 mg (150 mg TID), 600 mg (200 mg TID), 750 mg (250 mg TID), and 900 mg (300 mg TID) at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774414|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774415|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of>50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774416|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774417|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774418|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774419|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774469|NCT01494584|E2|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an up-titrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774420|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774421|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774422|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774423|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774424|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774425|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774426|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774427|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774428|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774429|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774430|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774431|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774507|NCT01494545|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774508|NCT01494532|B7|Baseline|Total|Total of all reporting groups
774432|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774433|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774434|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774435|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774436|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774437|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774438|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774439|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774440|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774441|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774442|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774443|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774732|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
776376|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
774444|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774445|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774446|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774447|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774448|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774449|NCT01494584|O5|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774450|NCT01494584|O4|Outcome|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774451|NCT01494584|O3|Outcome|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774452|NCT01494584|O2|Outcome|Regimen A: Ezogabine/Retigabine 300 mg, Then 450 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants then received an uptitrated dose of 450 mg/day ezogabine/retigabine as 150 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774453|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774454|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774455|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774456|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774457|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774458|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774459|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774460|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774461|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774462|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774463|NCT01494584|O3|Outcome|Regimen A: E/R 300/450/ 600/750 mg Then 900 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally. At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. At week 4 (Day 28), par. received 750 mg/day administered as 250 mg IR tablets TID orally. At week 5 (Day 35), par. received 900 mg/day administered as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774464|NCT01494584|O2|Outcome|Regimen A: E/R 300/450 mg Then 600 mg|Par. with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. At week two (Day 14), par. received 450 mg/day administered as 150 mg IR tablets TID orally.At week 3 (Day 21), par. received 600 mg/day administered as 200 mg IR tablets TID orally. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774465|NCT01494584|O1|Outcome|Regimen A: Ezogabine/Retigabine (E/R) 300 mg|Participants (par.) with a body weight of >50 kilograms (kg) received a starting dose of 300 milligrams per day (mg/day) ezogabine/retigabine adminstered as 100 mg immediate release (IR) tablets three times a day (TID) orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774466|NCT01494584|E5|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600/750, Then 900 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg, 600 mg, and 750 mg (as 150 mg IR, 200 mg IR, and 250 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 900 mg/day ezogabine/retigabine as 300 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774467|NCT01494584|E4|Reported Event|Regimen A: Ezogabine/Retigabine 300/450/600 mg, Then 750 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received up-titrated doses of ezogabine/retigabine 450 mg and 600 mg (as 150 mg IR and 200 mg IR tablets, respectively, TID orally) initially, then received an up-titrated dose of 750 mg/day ezogabine/retigabine as 250 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774468|NCT01494584|E3|Reported Event|Regimen A: Ezogabine/Retigabine 300/450 mg, Then 600 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administered as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. These participants received an up-titrated dose of 450 mg/day ezogabine/retigabine (as 150 mg IR tablets TID orally) initially, then received an up-titrated dose of 600 mg/day ezogabine/retigabine as 200 mg IR tablets TID orally. The TID daily dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774782|NCT01493687|E1|Reported Event|CD5024 1% Cream - Part A|Part A: CD5024 1% Cream, once daily application for 12 weeks
774470|NCT01494584|E1|Reported Event|Regimen A: Ezogabine/Retigabine 300 mg|Participants with a body weight of >50 kg received a starting dose of 300 mg/day ezogabine/retigabine administerd as 100 mg IR tablets TID orally and underwent weekly up-titration at a frequency of no more than once per week. The TID dosing regimen was administered at an 8-hour dosing interval or a 6-, 6-, 12-hour dosing interval.
774471|NCT01494545|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774472|NCT01494545|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774473|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774474|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774475|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774476|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774477|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774478|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774479|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774480|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
774481|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
774482|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774483|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
774484|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
774485|NCT01494545|O3|Outcome|Delefilcon A, Both Eyes|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774486|NCT01494545|O2|Outcome|Delefilcon A, Left Eye|Delefilcon A contact lenses worn in left eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
774487|NCT01494545|O1|Outcome|Delefilcon A, Right Eye|Delefilcon A contact lenses worn in right eye on a daily wear, daily disposable basis for two weeks. A new lens was inserted each day.
774488|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774489|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774490|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774491|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774492|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774493|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774494|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774495|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774496|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774497|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774498|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774499|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774500|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774501|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774502|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774503|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774504|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774505|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774506|NCT01494545|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for two weeks. A new pair was inserted each day.
774509|NCT01494532|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774510|NCT01494532|B5|Baseline|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774511|NCT01494532|B4|Baseline|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774512|NCT01494532|B3|Baseline|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774513|NCT01494532|B2|Baseline|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774514|NCT01494532|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774515|NCT01494532|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774516|NCT01494532|P5|Participant Flow|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774517|NCT01494532|P4|Participant Flow|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774518|NCT01494532|P3|Participant Flow|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774519|NCT01494532|P2|Participant Flow|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774520|NCT01494532|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774521|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774536|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774522|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774523|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774524|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774525|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774526|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774527|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774528|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774529|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774530|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774531|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774532|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774533|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774534|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774535|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774537|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774538|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774539|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774540|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774541|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774542|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774543|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774544|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774545|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774546|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774547|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774548|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774549|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774550|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774680|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774551|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774552|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774553|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774554|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774555|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774556|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774557|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774558|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774559|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774560|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774561|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774562|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774563|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774564|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774565|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774566|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774567|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774568|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774569|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774570|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774571|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774572|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774573|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774574|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774575|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774576|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774577|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774578|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774783|NCT01493557|B4|Baseline|Total|Total of all reporting groups
774579|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774580|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774581|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774582|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774583|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774584|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774585|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774586|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774587|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774588|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774589|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774590|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774591|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774592|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774722|NCT01494467|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
774723|NCT01494467|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
792006|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
774593|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774594|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774595|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774596|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774597|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774598|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774599|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774600|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774601|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774602|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774603|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774604|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774605|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774606|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774607|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774608|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774609|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774610|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774611|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774612|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774613|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774614|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774615|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774616|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774617|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774618|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774619|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774620|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
792007|NCT01433263|O1|Outcome|30mg/kg BYM338|
774621|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774622|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774623|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774624|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774625|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774626|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774627|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774628|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774629|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774630|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774631|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774632|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774633|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774634|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774724|NCT01494467|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
774725|NCT01494467|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
792008|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
774635|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774636|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774637|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774638|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774639|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774640|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774641|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774642|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774643|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774644|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774645|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774646|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774647|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774648|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774649|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774650|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774651|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774652|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774653|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774654|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774655|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774656|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774657|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774658|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774659|NCT01494532|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774660|NCT01494532|O5|Outcome|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774661|NCT01494532|O4|Outcome|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774662|NCT01494532|O3|Outcome|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
792009|NCT01433263|O1|Outcome|30mg/kg BYM338|
774663|NCT01494532|O2|Outcome|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774664|NCT01494532|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774665|NCT01494532|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were switched to ropinirole PR 16.0 mg/day for 4 days then 8.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774666|NCT01494532|E5|Reported Event|Treatment Group E: 16 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6 and 16 mg/day at Week 8. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 12.0 mg/day for 4 days then 6.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774667|NCT01494532|E4|Reported Event|Treatment Group D: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4 and 12 mg/day at Week 6. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 8.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774668|NCT01494532|E3|Reported Event|Treatment Group C: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to ropinirole PR 6.0 mg/day for 4 days then 4.0 mg/day for 3 days for down-titration before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774669|NCT01494532|E2|Reported Event|Treatment Group B: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to study Week 17. Par. reaching their target dose and completing the Maintenance Period or withdrawing prematurely were switched to placebo for down-titration for 1 Week before completing a follow-up visit 2 weeks after receiving the last dose of study medication.
774670|NCT01494532|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching prolonged release (PR) placebo tablet once daily (OD) for up to 17 Weeks followed by down titration with placebo over 1 week. Par. completed a follow-up visit 2 weeks after receiving the last dose of study medication.
774671|NCT01494506|B4|Baseline|Total|Total of all reporting groups
774672|NCT01494506|B3|Baseline|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
774673|NCT01494506|B2|Baseline|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
774674|NCT01494506|B1|Baseline|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
774675|NCT01494506|P3|Participant Flow|MM-398 + 5-FU + Leucovorin (Arm C)|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774676|NCT01494506|P2|Participant Flow|5-FU + Leucovorin (Arm B)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774677|NCT01494506|P1|Participant Flow|MM-398 (Arm A)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774678|NCT01494506|O2|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774679|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
792010|NCT01433263|O2|Outcome|Placebo / Late 30mg/kg BYM338|
774681|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774682|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774683|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774684|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774685|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774686|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774687|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774688|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774689|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774690|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774691|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774692|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774693|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774694|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774695|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774696|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774726|NCT01494467|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
774727|NCT01494467|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
774728|NCT01494467|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
774697|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774698|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774699|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774700|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774701|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774702|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774703|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774704|NCT01494506|O4|Outcome|5-FU + Leucovorin (Combo Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774705|NCT01494506|O3|Outcome|MM-398 + 5-FU + Leucovorin(Arm C) Combo Therapy Comparison|"MM-398 80 mg/m2 IV every 2 weeks Patients who were homozygous for UGT1A1*28 allele and were randomized to Arm C, received the first cycle of therapy at a reduced dose of 60 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased to 80 mg/m2.~5-FU 2400 mg/m2 IV over 46-hours, and~Leucovorin l + d racemic form 400 mg/m2, or l form 200 mg/m2 IV over 30 minutes, every 2 weeks"
774706|NCT01494506|O2|Outcome|5-FU + Leucovorin (Arm B) (Mono Therapy Comparison)|"5-FU 2000 mg/m2 IV over 24-hours, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle~Leucovorin l + d racemic form 200 mg/m2, or l form 100 mg/m2 IV over 30 minutes, every week for 4 weeks (days 1, 8, 15 and 22), followed by 2 weeks of rest, in a 6 week cycle."
774707|NCT01494506|O1|Outcome|MM-398 Arm A (Mono Therapy Comparison)|• MM-398 120 mg/m2 IV on Day 1of a 3 weekly cycle Patients who were homozygous for UGT1A1*28 allele received the first cycle of therapy at a reduced dose of 80 mg/m2. If the patient did not experience any drug related toxicity after the first administration of MM-398, from cycle 2 onwards, the dose could be increased in increments of 20 mg/m2 up to a maximum of 120 mg/m2.
774708|NCT01494506|E3|Reported Event|MM-398, 5-FU and Leucovorin|"MM-398, 5-FU and Leucovorin Q2W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
774709|NCT01494506|E2|Reported Event|5 Fluorouracil and Leucovorin IV|"5 Fluorouracil and Leucovorin IV~5 Fluorouracil: Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks~Leucovorin: Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
774710|NCT01494506|E1|Reported Event|MM-398|"MM-398 Q3W IV~MM-398: Arm A: MM-398 120 mg/m2 IV Q3W~Arm C: MM-398 80mg/m2 IV Q2W"
774711|NCT01494467|B3|Baseline|Total|Total of all reporting groups
774712|NCT01494467|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
774713|NCT01494467|B1|Baseline|CD5024 1% Cream|"Part A: CD5024 1% Cream, once daily application for 12 weeks~Part B: CD5024 1% Cream, once daily application for 40 weeks"
774714|NCT01494467|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
774715|NCT01494467|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
774716|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
774717|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
774718|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
774719|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
774720|NCT01494467|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
774721|NCT01494467|O1|Outcome|CD5024 1% Cream|CD5024 1% Cream, once daily application for 12 weeks
774733|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
774734|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
774735|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
774736|NCT01494350|O1|Outcome|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
774737|NCT01494350|E1|Reported Event|WR 279,396 Topical Cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
774738|NCT01494298|B3|Baseline|Total|Total of all reporting groups
774739|NCT01494298|B2|Baseline|Controls|African American Men without diabetes
774740|NCT01494298|B1|Baseline|T2DM|African American Men with Type 2 Diabetes
774741|NCT01494298|P2|Participant Flow|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
774742|NCT01494298|P1|Participant Flow|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
774743|NCT01494298|O2|Outcome|Controls|
774744|NCT01494298|O1|Outcome|T2DM|
774745|NCT01494298|O2|Outcome|Controls|African-American men without type 2 diabetes who are not taking cholesterol lowering medications
774746|NCT01494298|O1|Outcome|T2DM|African-American men with type 2 diabetes who are not taking cholesterol lowering medications
774747|NCT01494298|O2|Outcome|Controls|
774748|NCT01494298|O1|Outcome|T2DM|
774749|NCT01494298|E2|Reported Event|Controls|African American men without type 2 diabetes and not taking cholesterol-lowering medications.
774750|NCT01494298|E1|Reported Event|T2DM|African American men with type 2 diabetes and not taking cholesterol-lowering medications.
774751|NCT01493947|B3|Baseline|Total|Total of all reporting groups
774752|NCT01493947|B2|Baseline|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
774753|NCT01493947|B1|Baseline|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
774754|NCT01493947|P2|Participant Flow|Metronidazole 0.75% Cream|Metronidazole 0.75% cream applied twice daily on the face during 16-week
774755|NCT01493947|P1|Participant Flow|Ivermectin|Ivermectin applied once daily on the face during 16-week
774756|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
774757|NCT01493947|O1|Outcome|CD5024|CD5024: CD5024 applied once daily on the face during 16-week plus 36-week extension period.
774758|NCT01493947|O2|Outcome|Metronidazole 0.75% Cream|Metronidazole 0.75% cream: Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
774759|NCT01493947|O1|Outcome|Ivermectin|Ivermectin: Ivermectin applied once daily on the face during 16-week plus 36-week extension period.
774760|NCT01493947|E4|Reported Event|Metronidazole 0.75% Cream Period B|36-week extension period : only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible.
774761|NCT01493947|E3|Reported Event|Ivermectin 1% Cream Period B|36-week extension period :only subjects with an IGA of 0 or 1 at Week 16 (i.e., at the last visit of Period A) were eligible
774762|NCT01493947|E2|Reported Event|Metronidazole 0.75% Cream Period A|Metronidazole 0.75% cream applied twice daily on the face during 16-week
774763|NCT01493947|E1|Reported Event|Ivermectin 1% Cream Period A|Ivermectin applied once daily on the face during 16-week
774764|NCT01493687|B3|Baseline|Total|Total of all reporting groups
774765|NCT01493687|B2|Baseline|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application for 12 weeks~Part B: Azelaic acid 15% Gel, twice daily application for 40 weeks"
774766|NCT01493687|B1|Baseline|CD5024 1% Cream|Part A: CD5024 1% Cream, once daily application for 12 weeks Part B: CD5024 1% Cream, once daily application for 40 weeks
774767|NCT01493687|P2|Participant Flow|CD5024 Vehicle Cream/Azelaic Acid 15% Gel|"Part A: CD5024 Vehicle Cream, once daily application~Part B: Azelaic acid 15% Gel, twice daily application"
774768|NCT01493687|P1|Participant Flow|CD5024 1% Cream|Part A & B: CD5024 1% Cream, once daily application
774769|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
774770|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
774771|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
774772|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
774773|NCT01493687|O2|Outcome|CD5024 Vehicle Cream|CD5024 Vehicle Cream, once daily application for 12 weeks
774774|NCT01493687|O1|Outcome|CD5024 1% Cream|CD5024: CD5024 1% Cream, once daily application for 12 weeks
774775|NCT01493687|E8|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Overall|Overall number of subjects with adverse events for the entire duration of study
774776|NCT01493687|E7|Reported Event|CD5024 1% Cream - Overall|Overall number of subjects with adverse events for the entire duration of study
774777|NCT01493687|E6|Reported Event|CD5024 Vehicle Cream/Azelaic Acid 15% Gel - Part C|Part C: 4 week safety follow up. No drug applications
774778|NCT01493687|E5|Reported Event|CD5024 1% Cream - Part C|Part C: 4 week safety follow up. No drug applications
774779|NCT01493687|E4|Reported Event|Azelaic Acid 15% Gel - Part B|Part B: Subjects in the CD5024 Vehicle Cream arm applied Azelaic Acid 15% Gel twice daily for 40 weeks
774780|NCT01493687|E3|Reported Event|CD5024 1% Cream - Part B|Part B CD5024 1% Cream, once daily application for 40 weeks
774781|NCT01493687|E2|Reported Event|CD5024 Vehicle Cream - Part A|Part A: CD5024 Vehicle Cream, once daily application for 12 weeks
774785|NCT01493557|B2|Baseline|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774786|NCT01493557|B1|Baseline|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774787|NCT01493557|P3|Participant Flow|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
774788|NCT01493557|P2|Participant Flow|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774789|NCT01493557|P1|Participant Flow|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774790|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774791|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774792|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774793|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774794|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774795|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774796|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774797|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774798|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774799|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774800|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774801|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774802|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774803|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774804|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774805|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774806|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774807|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774808|NCT01493557|O2|Outcome|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774947|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
774809|NCT01493557|O1|Outcome|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774810|NCT01493557|E3|Reported Event|Pradaxa, Never Randomized|Patients who were treated for 3 months with Pradaxa ® and were never randomized to management strategies.
774811|NCT01493557|E2|Reported Event|Pantoprazole 40 mg (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to delayed release tablet pantoprazole 40 mg once daily in the Morning (q.a.m) (4 weeks).
774812|NCT01493557|E1|Reported Event|Pradaxa, 30 Minutes After a Meal (Randomized)|Randomized patients that develop gastrointestinal symptoms (GIS) were orally administered to Pradaxa (dabigatran etexilate) 150 mg or Pradaxa (dabigatran etexilate) 75 mg twice daily ( b.i.d.) taken with food (150 mg or 110 mg b.i.d. in Canada), within 30 minutes after a meal (4 weeks).
774813|NCT01493531|B4|Baseline|Total|Total of all reporting groups
774814|NCT01493531|B3|Baseline|Placebo + Allopurinol|
774815|NCT01493531|B2|Baseline|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
774816|NCT01493531|B1|Baseline|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
774817|NCT01493531|P3|Participant Flow|Placebo + Allopurinol|
774818|NCT01493531|P2|Participant Flow|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
774819|NCT01493531|P1|Participant Flow|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
774820|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
774821|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
774822|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
774823|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
774824|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
774825|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
774826|NCT01493531|O3|Outcome|Placebo + Allopurinol|placebo qd plus allopurinol
774827|NCT01493531|O2|Outcome|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
774828|NCT01493531|O1|Outcome|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
774829|NCT01493531|E3|Reported Event|Placebo + Allopurinol|
774830|NCT01493531|E2|Reported Event|Lesinurad 400 mg + Allopurinol|lesinurad 400 mg qd plus allopurinol
774831|NCT01493531|E1|Reported Event|Lesinurad 200 mg + Allopurinol|lesinurad 200 mg qd plus allopurinol
774832|NCT01493427|B1|Baseline|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
774833|NCT01493427|P1|Participant Flow|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
774834|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
774835|NCT01493427|O1|Outcome|TRAVATAN® BAK-free|Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks
774836|NCT01493427|E1|Reported Event|TRAVATAN® BAK-free|"Travoprost 0.004%, 1 drop self-administered to the study eye(s) once daily, every evening at around 8:00 pm, for 12 weeks~Travoprost 0.004%: Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative"
774837|NCT01493180|B3|Baseline|Total|Total of all reporting groups
774838|NCT01493180|B2|Baseline|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
774839|NCT01493180|B1|Baseline|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
774840|NCT01493180|P2|Participant Flow|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
774841|NCT01493180|P1|Participant Flow|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
774842|NCT01493180|O2|Outcome|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
774843|NCT01493180|O1|Outcome|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
774844|NCT01493180|E2|Reported Event|Sodium Hyaluronate Ophthalmic Solution|Sodium hyaluronate ophthalmic solution 0.1%
774845|NCT01493180|E1|Reported Event|OPC-12759 Ophthalmic Suspension|OPC-12759 ophthalmic suspension 2%
774846|NCT01493167|B1|Baseline|Woodcast Circular System Casts|Operatively treated adult patients needing a post-operative Circular Woodcast scaphoid-type cast
774847|NCT01493167|P1|Participant Flow|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
774848|NCT01493167|O1|Outcome|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
774849|NCT01493167|E1|Reported Event|Limb Casting/Splinting|"Patient age 0-90 years. Patient treatment requires extremity immobilization~limb casting/splinting: ankle and arm cast"
774850|NCT01493089|B3|Baseline|Total|Total of all reporting groups
774851|NCT01493089|B2|Baseline|Losec|Treatment of heartburn with Losec
774852|NCT01493089|B1|Baseline|Zegerid|Treatment of heartburn with Zegerid
774853|NCT01493089|P2|Participant Flow|Losec|Treatment of heartburn with 20mg Losec over-capsulated capsule plus placebo suspension once a day
774854|NCT01493089|P1|Participant Flow|Zegerid|Treatment of heartburn with 20mg Zegerid suspension plus over-encapsulated placebo capsule once a day
774855|NCT01493089|O2|Outcome|Losec Group|
774856|NCT01493089|O1|Outcome|Zegerid Group|
774857|NCT01493089|O2|Outcome|Losec Group|
774858|NCT01493089|O1|Outcome|Zegerid Group|
774859|NCT01493089|O2|Outcome|Losec Group|
774860|NCT01493089|O1|Outcome|Zegerid Group|
774861|NCT01493089|O2|Outcome|Losec Group|
774862|NCT01493089|O1|Outcome|Zegerid Group|
774863|NCT01493089|O2|Outcome|Losec Group|
774870|NCT01492439|B2|Baseline|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774871|NCT01492439|B1|Baseline|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774872|NCT01492439|P2|Participant Flow|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774873|NCT01492439|P1|Participant Flow|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a week for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774874|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774875|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774876|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774877|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774878|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774879|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774880|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774881|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774882|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774883|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774884|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774885|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774886|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774887|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774888|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774889|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774890|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774891|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774892|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774893|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774894|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774895|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774896|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774897|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774898|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774899|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774900|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774901|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774902|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774903|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774904|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774905|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774906|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774948|NCT01492400|E2|Reported Event|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
776377|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
774907|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774908|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774909|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774910|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774911|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774912|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774913|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774914|NCT01492439|O2|Outcome|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774915|NCT01492439|O1|Outcome|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774916|NCT01492439|E2|Reported Event|Supported Education Only|Participants in this group received all services and supports provided by the Redirection Through Education program at George Brown College. They did not receive the additional cognitive remediation training provided to those randomized to the experimental arm of the study.
774917|NCT01492439|E1|Reported Event|Cognitive Remediation + Supported Education|Participants in this group received cognitive remediation training in addition to supported education provided by the Redirection Through Education program at George Brown College. Cognitive remediation had two components: computer-based cognitive exercise sessions held twice a weekly for 10 weeks (approximately 45 minutes) and 10 weekly group discussion sessions (approximately 60 minutes).
774918|NCT01492426|B3|Baseline|Total|Total of all reporting groups
774919|NCT01492426|B2|Baseline|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
774920|NCT01492426|B1|Baseline|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
774921|NCT01492426|P2|Participant Flow|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
774922|NCT01492426|P1|Participant Flow|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
774923|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food.
774924|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
775072|NCT01491919|E1|Reported Event|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
774925|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
774926|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
774927|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
774928|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a+ Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a)180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
774929|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200mg per day was administered twice daily with food.
774930|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
774931|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
774932|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000 – 1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
774933|NCT01492426|O2|Outcome|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000–1200 mg per day was administered twice daily with food.
774934|NCT01492426|O1|Outcome|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000–1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day).
774935|NCT01492426|E2|Reported Event|Telaprevir + PEG-IFN Alpha-2a + Ribavirin|Participants received 2 telaprevir 375-mg tablets orally 3 times a day for 12 weeks. PEG-IFN alpha-2a 180 µg was coadministered subcutaneously once a week for 24 or 48 weeks depending on response, and ribavirin in a body weight stratified dose range of 1000-1200 mg per day was administered twice daily with food
774936|NCT01492426|E1|Reported Event|Daclatasvir + PEG-IFN Alpha-2a + Ribavirin|Participants received daclatasvir 60-mg tablet orally once daily for 24 weeks in combination with pegylated interferon alpha-2a (PEG-IFN alpha-2a) 180 µg administered subcutaneously once a week for 24 or 48 weeks and ribavarin administered in a body weight stratified dose range of 1000-1200 mg per day (for participants weighing less than 75 kg, the total dose was 1000 mg per day and for those weighing greater than or equal to 75 kg, the dose was 1200 mg per day)
774937|NCT01492400|B3|Baseline|Total|Total of all reporting groups
774938|NCT01492400|B2|Baseline|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
774939|NCT01492400|B1|Baseline|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
774940|NCT01492400|P2|Participant Flow|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
774941|NCT01492400|P1|Participant Flow|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
774942|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
774943|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
774944|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
774945|NCT01492400|O1|Outcome|Dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
774946|NCT01492400|O2|Outcome|Ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
774951|NCT01492088|B3|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774952|NCT01492088|B2|Baseline|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774953|NCT01492088|B1|Baseline|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774954|NCT01492088|P3|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774955|NCT01492088|P2|Participant Flow|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774956|NCT01492088|P1|Participant Flow|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774957|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774958|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774959|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774960|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774961|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774962|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774963|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774964|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774965|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774966|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774967|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774968|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775073|NCT01491737|B3|Baseline|Total|Total of all reporting groups
775522|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775164|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
774969|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774970|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774971|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774972|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774973|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774974|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774975|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774976|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774977|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774978|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774979|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774980|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774981|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774982|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774983|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774984|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774985|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774986|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
792011|NCT01433263|O1|Outcome|30mg/kg BYM338|
774987|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774988|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774989|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774990|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774991|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774992|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774993|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774994|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774995|NCT01492088|O3|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774996|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r Hodgkin Lymphoma (HL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774997|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
774998|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
774999|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775000|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
775001|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775002|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
775003|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775004|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle starting from Cycle 2 until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
775005|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775038|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775006|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
775007|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775008|NCT01492088|O2|Outcome|Brentuximab Vedotin 1.8 mg/kg: Phase 1|Brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
775009|NCT01492088|O1|Outcome|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775010|NCT01492088|E3|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r sALCL Only|Participants with r/r systemic anaplastic large-cell lymphoma (sALCL) received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
775011|NCT01492088|E2|Reported Event|Brentuximab Vedotin 1.8 mg/kg: Phase 1 and 2 r/r HL Only|Participants with r/r HL received brentuximab vedotin 1.8 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle until there was evidence of disease progression or unacceptable toxicity (Up to 16 cycles). Treatment with brentuximab vedotin beyond 16 cycles was permitted at the joint discretion of the sponsor and the investigator for those participants experiencing continued clinical benefit.
775012|NCT01492088|E1|Reported Event|Brentuximab Vedotin 1.4 mg/kg: Phase 1|Brentuximab vedotin 1.4 mg/kg, 30-minute IV infusion, Day 1 of every 21-day cycle, until there was evidence of disease progression or unacceptable toxicity.
775013|NCT01491984|B3|Baseline|Total|Total of all reporting groups
775014|NCT01491984|B2|Baseline|Intubation Order MAC/Levitan|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice).
775015|NCT01491984|B1|Baseline|Intubation Order Levitan/MAC|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
775016|NCT01491984|P2|Participant Flow|Macintosh/Levitan FPS Laryngoscope Intubation Order|"traditional MAC intubation~laryngoscopy view with MAC :"
775017|NCT01491984|P1|Participant Flow|Levitan FPS/Mac Laryngoscope Intubation Order|"Intubation with Levitan~laryngoscopy view with Levitan :"
775018|NCT01491984|O2|Outcome|MAC/Levitan Intubation|Laryngoscopy with MAC then Levitan
775019|NCT01491984|O1|Outcome|Levitan/MAC Intubation|Laryngoscopy with Levitan, then MAC
775020|NCT01491984|E2|Reported Event|Macintosh Intubation|A size 7.0-mm endotracheal tube with a malleable stylet was used to facilitate Macintosh intubation (standard practice)
775021|NCT01491984|E1|Reported Event|Levitan FPS Intubation|The LFS is used to guide and confirm endotracheal placement of endotracheal tubes during routine laryngoscopy.
775022|NCT01491919|B4|Baseline|Total|Total of all reporting groups
775023|NCT01491919|B3|Baseline|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775024|NCT01491919|B2|Baseline|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775025|NCT01491919|B1|Baseline|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775026|NCT01491919|P3|Participant Flow|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775027|NCT01491919|P2|Participant Flow|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775028|NCT01491919|P1|Participant Flow|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775029|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775030|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775031|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775032|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775033|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775034|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775035|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775036|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775037|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775039|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775040|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775041|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775042|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775043|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775044|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775045|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775046|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775047|NCT01491919|O2|Outcome|Lisinopril Standard of Care (SOC)|These protocol participants were enrolled and continued on the lisinopril dose prescribed as standard of care. They were assigned to the appropriate eGFR and dose level stratum (rounding to the closest dose level). Since the lisinopril dose was assigned based on standard of care, a patient was enrolled without regard to open/closed status of the dose stratum in this group. Therefore, over enrollment of a specific dose and eGFR stratum was allowed for participants enrolled he the Lisinopril-naive group to accommodate these valuable low-risk participants already taking lisinopril.
775048|NCT01491919|O1|Outcome|Lisinopril-naive|These protocol participants were not randomized. Instead, the older age group (7-17 years) were first enrolled consecutively into each dose level, starting with the lowest dose level (0.1 mg/kg per day). After enrollment is complete in the low dose level for an eGFR strata, enrollment will commence for the intermediate (0.2 mg/kg per day) dosage in that strata, followed by the high (0.4 mg/kg per day) dosage level. Enrollment for the 2-6 years age group did not begin until enrollment in the older age group (7-17 years) for the low and intermediate dosage level at each eGFR strata is complete.
775049|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775050|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775051|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775052|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775053|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775054|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775055|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775056|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775057|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775058|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775059|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775060|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775061|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775062|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775063|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775064|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775065|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775066|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775067|NCT01491919|O3|Outcome|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775068|NCT01491919|O2|Outcome|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
775069|NCT01491919|O1|Outcome|Low Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.1 mg/kg/day
775070|NCT01491919|E3|Reported Event|High Dose: Lisinopril|Participants will initially receive study medication at 0.2 mg/kg/day for 5±2 days. If blood tests exclude drug-related toxicity, then the lisinopril dose will be increased to 0.4 mg/kg/day and participants will continue to complete the 14±3 day Treatment Period.
775071|NCT01491919|E2|Reported Event|Medium Dose: Lisinopril|Participants will receive study medication for 14±3 days at a dose 0.2 mg/kg/day
794969|NCT01422356|E1|Reported Event|12 Month Cohort|
775074|NCT01491737|B2|Baseline|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775075|NCT01491737|B1|Baseline|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775076|NCT01491737|P2|Participant Flow|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775077|NCT01491737|P1|Participant Flow|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775078|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775079|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775080|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775081|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775082|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775083|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775357|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775084|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775085|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775086|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775087|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775088|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775089|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775090|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775091|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775092|NCT01491737|O2|Outcome|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775093|NCT01491737|O1|Outcome|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775358|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775094|NCT01491737|E2|Reported Event|Arm B: Trastuzumab|Participants received trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775095|NCT01491737|E1|Reported Event|Arm A: Pertuzumab and Trastuzumab|Participants received pertuzumab at a loading dose of 840 mg followed by 420 mg along with trastuzumab at a loading dose of 8 mg/kg of body weight followed by 6 mg/kg of body weight on Day 1 or Day 2 of each 3-weekly cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death, or the predefined end of study whichever occurs first. Participant received aromatase inhibitor (AI), orally as per product labeling (anastrozole: 1 mg once daily or letrozole: 2.5 mg once daily). Participants receiving induction chemotherapy up to the first 18‑24 weeks of the treatment period were to receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective product labeling.
775096|NCT01491672|B4|Baseline|Total|Total of all reporting groups
775097|NCT01491672|B3|Baseline|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775098|NCT01491672|B2|Baseline|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775099|NCT01491672|B1|Baseline|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775100|NCT01491672|P3|Participant Flow|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775101|NCT01491672|P2|Participant Flow|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775102|NCT01491672|P1|Participant Flow|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775103|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
775104|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775105|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775106|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775107|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
775108|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775109|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775110|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775111|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
775112|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775113|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775114|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775115|NCT01491672|O4|Outcome|All Participants|All participants received RAD001 10 mg daily.
775116|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775117|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775118|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775119|NCT01491672|O3|Outcome|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775120|NCT01491672|O2|Outcome|Other Prior Vascular Endothelial Growth Factor (VEGF)|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775121|NCT01491672|O1|Outcome|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775122|NCT01491672|O1|Outcome|All Participants|All participants received RAD001 10 mg daily.
775123|NCT01491672|E3|Reported Event|Prior Cytokines|Participants, who received prior cytokine therapy, received RAD001 10 mg orally once daily.
775124|NCT01491672|E2|Reported Event|Other Prior Anti VEGF|Participants, who received prior anti-VEGF other than sunitinib, received RAD001 10 mg orally once daily.
775125|NCT01491672|E1|Reported Event|Prior Sunitinib|Participants, who received prior sunitinib therapy, received RAD001 10 mg orally once daily.
775126|NCT01491633|B1|Baseline|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775127|NCT01491633|P1|Participant Flow|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775128|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775129|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775130|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775131|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775132|NCT01491633|O1|Outcome|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775133|NCT01491633|E1|Reported Event|Dasatinib|"Dasatinib 140 mg by mouth each day~Dasatinib: 140 mg orally, daily in 28 day cycles"
775134|NCT01491607|B5|Baseline|Total|Total of all reporting groups
794970|NCT01422304|B3|Baseline|Total|Total of all reporting groups
775135|NCT01491607|B4|Baseline|BioThrax - Site 04|Subjects from Site 04 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
775136|NCT01491607|B3|Baseline|BioThrax - Site 03|Subjects from Site 03 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
775137|NCT01491607|B2|Baseline|BioThrax - Site 02|Subjects from Site 02 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
775138|NCT01491607|B1|Baseline|BioThrax - Site 01|Subjects from Site 01 who received all three doses of BioThrax within the allowable time window and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by Sponsor) on Day 63 were excluded.
775139|NCT01491607|P1|Participant Flow|BioThrax|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
775140|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775141|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775142|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775143|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775144|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775145|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775146|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775147|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775148|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775149|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775150|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775151|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775152|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775153|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775154|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775155|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775156|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775157|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775158|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775159|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775160|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775161|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775162|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775163|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775165|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775166|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775167|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775168|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775169|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of systemic reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775170|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775171|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775172|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775173|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775174|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775175|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775176|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775177|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775178|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775179|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775180|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775181|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775182|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775183|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775184|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775185|NCT01491607|O15|Outcome|BioThrax 3rd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775186|NCT01491607|O14|Outcome|BioThrax 3rd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775187|NCT01491607|O13|Outcome|BioThrax 3rd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775188|NCT01491607|O12|Outcome|BioThrax 3rd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775189|NCT01491607|O11|Outcome|BioThrax 3rd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775190|NCT01491607|O10|Outcome|BioThrax 2nd Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775191|NCT01491607|O9|Outcome|BioThrax 2nd Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775192|NCT01491607|O8|Outcome|BioThrax 2nd Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775193|NCT01491607|O7|Outcome|BioThrax 2nd Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775359|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775194|NCT01491607|O6|Outcome|BioThrax 2nd Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775195|NCT01491607|O5|Outcome|BioThrax 1st Vaccination - Total of Reactions|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775196|NCT01491607|O4|Outcome|BioThrax 1st Vaccination - Severe Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775197|NCT01491607|O3|Outcome|BioThrax 1st Vaccination - Moderate Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775198|NCT01491607|O2|Outcome|BioThrax 1st Vaccination - Mild Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775199|NCT01491607|O1|Outcome|BioThrax 1st Vaccination - No Reaction|The incidence of injection site reactions was evaluated in the population of subjects who had any diary data available during the 7-day-post-vaccination period
775200|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775201|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775202|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775203|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775204|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775205|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775206|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775207|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775208|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775209|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775210|NCT01491607|O1|Outcome|BioThrax - Days 63-100 Immunogenicity|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days, Day 70 ± 2 days, Day 84 ± 3 days, and Day 100 ± 3 days, inclusive. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Days 63, 70, 84, or 100 were excluded.
775361|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775211|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775212|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775213|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775214|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01, 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775215|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775216|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775217|NCT01491607|O5|Outcome|BioThrax - > 30 Years of Age|Participants > 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775218|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years in age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775219|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775220|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775221|NCT01491607|O1|Outcome|BioThrax - Day 70|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 70 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 70 were excluded.
775222|NCT01491607|O11|Outcome|BioThrax - Site 04|Participants enrolled at Site 04 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
775223|NCT01491607|O10|Outcome|BioThrax - Site 03|Participants enrolled at Site 03 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
775224|NCT01491607|O9|Outcome|BioThrax - Site 02|Participants enrolled at Site 02 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
775225|NCT01491607|O8|Outcome|BioThrax - Site 01|Participants enrolled at Site 01 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
775360|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
776378|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
775226|NCT01491607|O7|Outcome|BioThrax - Non-Caucasian|Non-Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
775227|NCT01491607|O6|Outcome|BioThrax - Caucasian|Caucasian participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
775228|NCT01491607|O5|Outcome|BioThrax- > 30 Years of Age|Participants > 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
775229|NCT01491607|O4|Outcome|BioThrax - ≤ 30 Years of Age|Participants ≤ 30 Years of Age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
775230|NCT01491607|O3|Outcome|BioThrax - Female|Female participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
775231|NCT01491607|O2|Outcome|BioThrax - Male|Male participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population..
775232|NCT01491607|O1|Outcome|BioThrax|Participants 18 to 65 years of age who received all three doses of BioThrax (0.5 mL) subcutaneously (SC) within the allowable time window (±2 days for Days 14 and 28) and had a blood sample collected for immunogenicity testing on Day 63 ± 2 days. Subjects with key protocol deviations that may have impacted assessment of immune response or sample testing (as determined by the Sponsor) on Day 63 were excluded from the Primary Per-Protocol Population.
775233|NCT01491607|E1|Reported Event|ITT Population|Participants 18 to 65 years of age who received at least one dose of BioThrax (0.5 mL) subcutaneously (SC).
775234|NCT01491490|B3|Baseline|Total|Total of all reporting groups
775235|NCT01491490|B2|Baseline|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
775236|NCT01491490|B1|Baseline|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
775237|NCT01491490|P2|Participant Flow|Placebo|Taken as 6 capsules, matched to taste and look like the active study medication.
775238|NCT01491490|P1|Participant Flow|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
775239|NCT01491490|O2|Outcome|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
775240|NCT01491490|O1|Outcome|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
775241|NCT01491490|E2|Reported Event|Placebo|Taken as 6 capsules once daily, matched to taste and look like the active study medication.
775242|NCT01491490|E1|Reported Event|GWP42003 : GWP42004 (40:1)|Active study medication as 4 capsules GWP42003 and 2 capsules GWP42004 once daily.
775243|NCT01491113|B6|Baseline|Total|Total of all reporting groups
775244|NCT01491113|B5|Baseline|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775245|NCT01491113|B4|Baseline|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775246|NCT01491113|B3|Baseline|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
776304|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
775247|NCT01491113|B2|Baseline|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775248|NCT01491113|B1|Baseline|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775249|NCT01491113|P5|Participant Flow|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775250|NCT01491113|P4|Participant Flow|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775251|NCT01491113|P3|Participant Flow|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775252|NCT01491113|P2|Participant Flow|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775253|NCT01491113|P1|Participant Flow|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775254|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analysis: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775255|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775265|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775256|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775257|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775258|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775259|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775260|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775261|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775262|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775263|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775264|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
776379|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
775266|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775267|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775268|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775269|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775270|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775271|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775272|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775273|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775274|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775275|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775276|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775347|NCT01491035|B1|Baseline|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775348|NCT01491035|P8|Participant Flow|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
795066|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
775277|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775278|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775279|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775280|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775281|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775282|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775283|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775284|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775285|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775286|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775287|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775288|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775289|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775290|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775291|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775292|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775293|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775294|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775295|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775296|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775297|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775298|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775349|NCT01491035|P7|Participant Flow|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775350|NCT01491035|P6|Participant Flow|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775299|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775300|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775301|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775302|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775303|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775304|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775305|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775306|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775307|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775308|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775309|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775351|NCT01491035|P5|Participant Flow|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775352|NCT01491035|P4|Participant Flow|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
796815|NCT01412281|E4|Reported Event|>60 Years - CSL HA Antigen|
775310|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775311|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775312|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775313|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775314|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775315|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775316|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775317|NCT01491113|O1|Outcome|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775318|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775353|NCT01491035|P3|Participant Flow|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775354|NCT01491035|P2|Participant Flow|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775319|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775320|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775321|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775322|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775323|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775324|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775325|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775326|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775327|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775328|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775329|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775355|NCT01491035|P1|Participant Flow|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775356|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
796816|NCT01412281|E3|Reported Event|>60 Years - AdImmune HA Antigen|
775330|NCT01491113|O4|Outcome|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775331|NCT01491113|O3|Outcome|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775332|NCT01491113|O2|Outcome|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775333|NCT01491113|O1|Outcome|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775334|NCT01491113|E5|Reported Event|Group E: End-stage Renal Disease|"Group E received Levetiracetam (LEV) 500 mg orally on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg was administered 1 h after the end of the first hemodialysis on Day 3.~The 4-h Hemodialysis was scheduled as follows:~Dialysis: 44 h to 48 h after the first dose (Day 3)~Dialysis: 92 h to 96 h after the first dose (Day 5)~Dialysis: 140 h after the first dose (Day 7)~Safety assessments and blood samplings were conducted until Day 7. Safety follow-up assessments were performed on Day 10.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44*, 44.25*, 44.5*, 45*, 46*, 47*, 48*, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing.~49 h-sample was taken before the additional dose. The 44 h, 92 h, and 140 h samples were taken before the start of the hemodialysis.~*Inflow blood, outflow blood, and dialysate fluid were collected."
775335|NCT01491113|E4|Reported Event|Group D: Severe Renal Impairment|"Patients with severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 7 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose"
775336|NCT01491113|E3|Reported Event|Group C: Moderate Renal Impairment|"Patients with moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 6 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose"
775337|NCT01491113|E2|Reported Event|Group B: Mild Renal Impairment|"Patients with mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects were orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings were conducted through Day 5 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetics (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose"
775338|NCT01491113|E1|Reported Event|Group A: Normal Renal Function|"Subjects with normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects were orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings were taken through to Day 4 during the Treatment Period, and safety follow-up assessments were performed on Day 8 according to the schedule of study assessments.~Blood samples for Pharmacokinetic (PK) analyses: Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose~Urine samples for PK analyses: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose"
775339|NCT01491035|B9|Baseline|Total|Total of all reporting groups
775340|NCT01491035|B8|Baseline|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775341|NCT01491035|B7|Baseline|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775342|NCT01491035|B6|Baseline|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775343|NCT01491035|B5|Baseline|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775344|NCT01491035|B4|Baseline|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775345|NCT01491035|B3|Baseline|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775346|NCT01491035|B2|Baseline|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775362|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775363|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775364|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775365|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775366|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775367|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775368|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775369|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775370|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775371|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775372|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775373|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775374|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775375|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775376|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775377|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775378|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775379|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775380|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775381|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775382|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775383|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775384|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775385|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775386|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775387|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775388|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775389|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775390|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775391|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775392|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775393|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775394|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775395|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775396|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775397|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775398|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775399|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775400|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775401|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775402|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775403|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775404|NCT01491035|O8|Outcome|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
798848|NCT01402115|B1|Baseline|Polycan|Polycan 150mg for 12 weeks
775405|NCT01491035|O7|Outcome|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775406|NCT01491035|O6|Outcome|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775407|NCT01491035|O5|Outcome|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775408|NCT01491035|O4|Outcome|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775409|NCT01491035|O3|Outcome|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775410|NCT01491035|O2|Outcome|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775411|NCT01491035|O1|Outcome|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775412|NCT01491035|E8|Reported Event|Children, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775413|NCT01491035|E7|Reported Event|Children, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775414|NCT01491035|E6|Reported Event|Children, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775415|NCT01491035|E5|Reported Event|Children, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775416|NCT01491035|E4|Reported Event|Adolescents, 20 mg|Vortioxetine: 20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
775417|NCT01491035|E3|Reported Event|Adolescents, 15 mg|Vortioxetine: 15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
775418|NCT01491035|E2|Reported Event|Adolescents, 10 mg|Vortioxetine: 10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
775419|NCT01491035|E1|Reported Event|Adolescents, 5 mg|Vortioxetine: 5 mg tablets for 14 days; orally; once daily
775420|NCT01491022|B3|Baseline|Total|Total of all reporting groups
775421|NCT01491022|B2|Baseline|Placebo Then Ampyra|Placebo for 4 weeks followed by 2 weeks washout followed by Ampyra 10 mg po bid for 4 weeks
775422|NCT01491022|B1|Baseline|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
775423|NCT01491022|P2|Participant Flow|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
775424|NCT01491022|P1|Participant Flow|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
775425|NCT01491022|O2|Outcome|Placebo|"placebo 4 weeks followed by Ampyra 10 mg po BID~placebo first, then Ampyra: placebo"
775426|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks~Ampyra first, then Placebo: 10 mg po bid for 4 weeks followed by placebo 4 weeks."
775427|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
775428|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
775429|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
775430|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
775431|NCT01491022|O2|Outcome|Placebo Then Ampyra|placebo for 4 weeks followed by 2 weeks washout followed by 4 weeks Ampyra 10 mg po BID
775432|NCT01491022|O1|Outcome|Ampyra Then Placebo|Ampyra 10 mg po BID for 4 weeks followed by 2 weeks washout followed by 4 weeks placebo
775433|NCT01491022|O2|Outcome|Placebo|"placebo 4 weeks followed by Ampyra 10 mg po BID~placebo first, then Ampyra: placebo"
775434|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID for 4 weeks followed by placebo 4 weeks~Ampyra first, then Placebo: 10 mg po bid for 4 weeks followed by placebo 4 weeks."
775435|NCT01491022|O2|Outcome|Placebo|placebo: placebo
775436|NCT01491022|O1|Outcome|Ampyra|"Ampyra 10 mg po BID~Dalfampridine: 10 mg po bid for 4 weeks"
775437|NCT01491022|E2|Reported Event|Placebo|placebo: placebo
775438|NCT01491022|E1|Reported Event|Ampyra|"Ampyra 10 mg po BID~Dalfampridine: 10 mg po bid for 4 weeks"
775439|NCT01489956|B3|Baseline|Total|Total of all reporting groups
775440|NCT01489956|B2|Baseline|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775441|NCT01489956|B1|Baseline|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775442|NCT01489956|P3|Participant Flow|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775443|NCT01489956|P2|Participant Flow|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775444|NCT01489956|P1|Participant Flow|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775523|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775524|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775445|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775446|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775447|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775448|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775449|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775450|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775451|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775452|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775453|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775454|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775455|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775456|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775457|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775458|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775459|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775460|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775461|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775462|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775484|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
798849|NCT01402115|P2|Participant Flow|Placebo|Placebo 15mg for 12 weeks
775463|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775464|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775465|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775466|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775467|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775468|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775469|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775470|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775471|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775472|NCT01489956|O3|Outcome|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775473|NCT01489956|O2|Outcome|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775474|NCT01489956|O1|Outcome|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775475|NCT01489956|E3|Reported Event|Immucothel Alone or Immucothel + Montanide (Part B)|Ten new, healthy participants ingested 50 mg of native keyhole limpet hemocyanin (KLH) orally. KLH, a protein extracted from a mollusk (a sea animal), was ingested on Days 0 through 4 and Days 10 through 14, for a total dose of 500 mg. The participants were then immunized using the strategy that produced an immune response in at least nine out of 10 participants in Part A (Immucothel alone or Immucothel plus Montanide) on Days 26 and 35.
775476|NCT01489956|E2|Reported Event|Immucothel + Montanide (Part A)|If an immune response was not observed in at least nine of the subjects after receiving Immucothel alone, 10 additional healthy subjects would be recruited and immunized with Immucothel (SQ) plus Montanide (SQ) on Day 0 and Day 9. If at least nine of the subjects had an immune response after receiving Immucothel plus Montanide, Part A of the study would be completed.
775477|NCT01489956|E1|Reported Event|Immucothel Alone (Part A)|Subjects received 100 µg Immucothel subcutaneously (SQ) on Day 0 and Day 9. If at least nine of the subjects demonstrated an immune response, Part A of the study would be complete.
775478|NCT01489891|B3|Baseline|Total|Total of all reporting groups
775479|NCT01489891|B2|Baseline|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
775480|NCT01489891|B1|Baseline|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
775481|NCT01489891|P2|Participant Flow|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
775482|NCT01489891|P1|Participant Flow|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated esophagogastroduodenoscopy (EGD)~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
775483|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
775485|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
775486|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
775487|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
775488|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
775489|NCT01489891|O2|Outcome|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
775490|NCT01489891|O1|Outcome|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
775491|NCT01489891|E2|Reported Event|Placebo|"Excipients without lidocaine. The flavour taste is the same of active comparator ensuring the masking.~Placebo : Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking)."
775492|NCT01489891|E1|Reported Event|Lidocaine Group|"Blinded spraying 50 mg of pharyngeal topical lidocaine 180 seconds before sedated EGD~Lidocaine : Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff)."
775493|NCT01489826|B10|Baseline|Total|Total of all reporting groups
775494|NCT01489826|B9|Baseline|Dexanabinol Expansion Phase|Open label, expansion phase to assess pharmacodynamics of dexanabinol in patients with advanced tumours at the MTD/MAD (30 mg/kg)
775495|NCT01489826|B8|Baseline|Dexanabinol Dose Escalation - Cohort 8|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775496|NCT01489826|B7|Baseline|Dexanabinol Dose Escalation - Cohort 7|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775497|NCT01489826|B6|Baseline|Dexanabinol Dose Escalation - Cohort 6|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775498|NCT01489826|B5|Baseline|Dexanabinol Dose Escalation - Cohort 5|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775499|NCT01489826|B4|Baseline|Dexanabinol Dose Escalation - Cohort 4|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775500|NCT01489826|B3|Baseline|Dexanabinol Dose Escalation - Cohort 3|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775501|NCT01489826|B2|Baseline|Dexanabinol Dose Escalation - Cohort 2|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775502|NCT01489826|B1|Baseline|Dexanabinol Dose Escalation - Cohort 1|Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours
775503|NCT01489826|P9|Participant Flow|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775504|NCT01489826|P8|Participant Flow|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775505|NCT01489826|P7|Participant Flow|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775506|NCT01489826|P6|Participant Flow|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775507|NCT01489826|P5|Participant Flow|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775508|NCT01489826|P4|Participant Flow|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775509|NCT01489826|P3|Participant Flow|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775510|NCT01489826|P2|Participant Flow|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775511|NCT01489826|P1|Participant Flow|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775512|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775513|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775514|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775515|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775516|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775517|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775518|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775519|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775520|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775521|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
776380|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
775525|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775526|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775527|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775528|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775529|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775530|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775531|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775532|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775533|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775534|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775535|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775536|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775537|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775538|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775539|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775540|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775541|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775542|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775543|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775544|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775545|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775546|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775547|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775548|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775549|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775550|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775551|NCT01489826|O6|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775552|NCT01489826|O5|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775553|NCT01489826|O4|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775554|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775555|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775556|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775557|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775558|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775559|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775560|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775561|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775562|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775563|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775564|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775565|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775566|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775567|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775568|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775569|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775570|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775571|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775572|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775573|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775574|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775575|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775576|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775577|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775578|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775579|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775580|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775581|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775582|NCT01489826|O7|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775583|NCT01489826|O6|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775584|NCT01489826|O5|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775585|NCT01489826|O4|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775586|NCT01489826|O3|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775587|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775588|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775589|NCT01489826|O9|Outcome|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775590|NCT01489826|O8|Outcome|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775591|NCT01489826|O7|Outcome|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775592|NCT01489826|O6|Outcome|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775593|NCT01489826|O5|Outcome|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775594|NCT01489826|O4|Outcome|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775595|NCT01489826|O3|Outcome|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775596|NCT01489826|O2|Outcome|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775597|NCT01489826|O1|Outcome|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775598|NCT01489826|E9|Reported Event|Dexanabinol Expansion Phase|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775599|NCT01489826|E8|Reported Event|Dexanabinol 36 mg/kg|Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775600|NCT01489826|E7|Reported Event|Dexanabinol 30 mg/kg|Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775601|NCT01489826|E6|Reported Event|Dexanabinol 22 mg/kg|Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775602|NCT01489826|E5|Reported Event|Dexanabinol 15 mg/kg|Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775603|NCT01489826|E4|Reported Event|Dexanabinol 12 mg/kg|Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775604|NCT01489826|E3|Reported Event|Dexanabinol 6 mg/kg|Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775605|NCT01489826|E2|Reported Event|Dexanabinol 3 mg/kg|Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775606|NCT01489826|E1|Reported Event|Dexanabinol 2 mg/kg|Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
775607|NCT01490931|B1|Baseline|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775608|NCT01490931|P1|Participant Flow|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775609|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775965|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775966|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775610|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775611|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775612|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775613|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775614|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775615|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775616|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775617|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775618|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775619|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775620|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775621|NCT01490931|O1|Outcome|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775622|NCT01490931|E1|Reported Event|Ketorolac Nasal Spray 31.5 mg (SPRIX)|"Recommended dose according to package insert in 18 - 64 year olds for moderate to moderately severe pain.~Ketorolac Tromethamine Nasal Spray: 15.75 mg nasal spray delivery to each nostril no more than every six hours"
775623|NCT01490866|B1|Baseline|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
775624|NCT01490866|P1|Participant Flow|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
775625|NCT01490866|O2|Outcome|Axitinib|All patients who received at least one dose of axitinib
775626|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab|All patients who received at least one dose of FOLFOX/bevacizumab
775627|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
775628|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
775672|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
776305|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
775629|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (a total of 16 weeks). After 4 cycles, axitinib maintenance will be administered. FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin.~FOLFOX/bevacizumab:~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by;IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day (PO BID)"
775630|NCT01490866|O1|Outcome|FOLFOX/Bevacizumab and Axitinib|"All patients receive FOLFOX/bevacizumab for four 28-day cycles (16 weeks). After 4 cycles, axitinib maintenance will be administered starting on Week 17. Maintenance treatment will continue until disease progression or intolerable toxicity occurs.~FOLFOX/bevacizumab ( FOLFOX is a combination of Leucovorin, fluorouracil and oxiloplatin):~5-Fluorouracil: 400 mg/m2 Days 1 and 15 by IV followed by 2400 mg/m2 over 46-48 hours Days 1 and 15 by continuous infusion;~Leucovorin: 400 mg/m2 given Days 1 and 15 by IV~Oxaliplatin: 85 mg/m2 Days 1 and 15 by IV~Bevacizumab: 5 mg/kg on Days 1 and 15 by IV~Maintenance:~- Axitinib: 5-mg tablets orally twice per day on Days 1 thru 28 of each cycle until disease progression or unacceptable toxicity occurs."
775631|NCT01490866|E1|Reported Event|FOLFOX/Bevacizumab and Axitinib|
775632|NCT01490840|B3|Baseline|Total|Total of all reporting groups
775633|NCT01490840|B2|Baseline|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775634|NCT01490840|B1|Baseline|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775635|NCT01490840|P2|Participant Flow|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775636|NCT01490840|P1|Participant Flow|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775637|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775638|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775673|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775930|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775639|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775640|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775641|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775642|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775643|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775644|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775645|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775646|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775674|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798850|NCT01402115|P1|Participant Flow|Polycan|Polycan 150mg for 12 weeks
775647|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775648|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775649|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775650|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775651|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775652|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775653|NCT01490840|O2|Outcome|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775654|NCT01490840|O1|Outcome|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775675|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798851|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
775655|NCT01490840|E2|Reported Event|Waiting|Fingolimod as baseline immunomodulatory multiple sclerosis treatment is prescribed as per clinical practice. During Phase 1, participants randomized to this arm did not receive e-training exercise. After a 6 month waiting period, phase 2, participants had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day.
775656|NCT01490840|E1|Reported Event|E-training|Fingolimod as baseline immunomodulatory multiple sclerosis treatment was prescribed as per clinical practice. During phase 1, participants randomized to this arm had an introductory group session, hosted by a sports therapist. The individual training schedule was comprised of strength exercises twice a week for 30-45 minutes and endurance training once a week for 20-60 minutes for 6 months. The participants documented each training session thoroughly via the web-based application (duration, type of exercises, number of repetitions and sets, perceived exertion). A standard course of corticosteroids (methylprednisolone) on an inpatient or outpatient basis was allowed for treatment of relapses as clinically warranted. Steroid treatment consisted of 3-5 days and up to 1,000 mg methylprednisolone/day. After 6 months, Phase 2, the same Phase 1 regimen applied.
775657|NCT01490294|B5|Baseline|Total|Total of all reporting groups
775658|NCT01490294|B4|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775659|NCT01490294|B3|Baseline|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775660|NCT01490294|B2|Baseline|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775661|NCT01490294|B1|Baseline|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775662|NCT01490294|P4|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775663|NCT01490294|P3|Participant Flow|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775664|NCT01490294|P2|Participant Flow|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775665|NCT01490294|P1|Participant Flow|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg body weight (BW) (0.01mL/kg) for stress magnetic resonance imaging (MRI) via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775666|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775667|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775668|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775669|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775670|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775671|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775929|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
798852|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
775676|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775677|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775678|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775679|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775680|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775681|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775682|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775683|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775684|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775685|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775686|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775687|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775688|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775689|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775690|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775691|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775692|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775693|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775694|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775695|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798853|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
775696|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775697|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775698|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775699|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775700|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775701|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775702|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775703|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775704|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775705|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775706|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775707|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775708|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775709|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775710|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775711|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775712|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775713|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775714|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775715|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798854|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
775716|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775717|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775718|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775719|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775720|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775721|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775722|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775723|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775724|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775725|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775726|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775727|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775728|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775729|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775730|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775731|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775732|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775733|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775734|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775735|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798855|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
775736|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775737|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775738|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775739|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775740|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775741|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775742|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775743|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775744|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775745|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775746|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775747|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775748|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775749|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775750|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775751|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775752|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775753|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775754|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775755|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798856|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
775756|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775757|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775758|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775759|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775760|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775761|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775762|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775763|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775764|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775765|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775766|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775767|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775768|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775769|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775770|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775771|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775772|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775773|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775774|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775775|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798857|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
775776|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775777|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775778|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775779|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775780|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775781|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775782|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775783|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775784|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775785|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775786|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775787|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775788|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775789|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775790|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775791|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775792|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775793|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775794|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775795|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798858|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
775796|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775797|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775798|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775799|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775800|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775801|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775802|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775803|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775804|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775805|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775806|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775807|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775808|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775809|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775810|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775811|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775812|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775813|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775814|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775815|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798859|NCT01402115|O2|Outcome|Placebo|Placebo 15mg for 12 weeks
775816|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775817|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775818|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775819|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775820|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775821|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775822|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775823|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775824|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775825|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775826|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775827|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775828|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775829|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775830|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775831|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775832|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775833|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775834|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775835|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798860|NCT01402115|O1|Outcome|Polycan|Polycan 150mg for 12 weeks
775836|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775837|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775838|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775839|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775840|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775841|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775842|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775843|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775844|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775845|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775846|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775847|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775848|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775849|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775850|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775851|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775852|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775853|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775854|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775855|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798861|NCT01402115|E2|Reported Event|Placebo|Placebo 15mg for 12 weeks
775856|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775857|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775858|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775859|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775860|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775861|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775862|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775863|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775864|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775865|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775866|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775867|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775868|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775869|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775870|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775871|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775872|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775873|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775874|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775875|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798862|NCT01402115|E1|Reported Event|Polycan|Polycan 150mg for 12 weeks
775876|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775877|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775878|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775879|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775880|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775881|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775882|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775883|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775884|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775885|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775886|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775887|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775888|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775889|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775890|NCT01490294|O4|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775891|NCT01490294|O3|Outcome|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775892|NCT01490294|O2|Outcome|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775893|NCT01490294|O1|Outcome|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775894|NCT01490294|E4|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.1 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.1 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775895|NCT01490294|E3|Reported Event|Gadobutrol 0.05 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.05 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.05 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
798863|NCT01402102|B3|Baseline|Total|Total of all reporting groups
775896|NCT01490294|E2|Reported Event|Gadobutrol 0.025 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.025 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.025 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775897|NCT01490294|E1|Reported Event|Gadobutrol 0.01 mmol/kg BW (Gadavist, BAY86-4875)|Participants received 1 i.v. bolus injections of Gadobutrol 0.01 mmol/kg BW (0.01mL/kg) for stress MRI via a power injector at a rate of 3 mL/s. The second i.v. bolus injection of Gadobutrol 0.01 mmol/kg BW was given after a 10-15 minutes wash-out period of the stressor for the rest MRI.
775898|NCT01490190|B1|Baseline|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
775899|NCT01490190|P1|Participant Flow|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
775900|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775901|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775902|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775903|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775904|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775905|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775906|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775907|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775908|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775909|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775910|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775911|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775912|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775913|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775914|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775915|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775916|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775917|NCT01490190|O1|Outcome|NuvaRing|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
775918|NCT01490190|E1|Reported Event|NuvaRing: Safety Population|Safety Population, which included all participants who met inclusion and exclusion criteria and who inserted NuvaRing at least once during the study period.
775919|NCT01490125|B1|Baseline|All Participants|All participants who entered the study and were randomized to any of the 3 treatment combinations: QVA149 plus placebo to tiotropium; tiotropium plus placebo to QVA149 or placebo to QVA149 plus placebo to tiotropium.
775920|NCT01490125|P6|Participant Flow|Tiotropium + Placebo +QVA149|Participants were randomized to sequence tiotropium + placebo + QVA149
775921|NCT01490125|P5|Participant Flow|Tiotropium + QVA149+ Placebo|Participants were randomized to sequence tiotropium + QVA149 + placebo
775922|NCT01490125|P4|Participant Flow|Placebo+ Tiotropium + QVA149|Participants were randomized to sequence placebo + tiotropium + QVA149
775923|NCT01490125|P3|Participant Flow|Placebo + QVA149 + Tiotropium|Participants were randomized to sequence placebo + QVA149 + tiotropium
775924|NCT01490125|P2|Participant Flow|QVA149+ Tiotropium+ Placebo|Participants were randomized to sequence QVA149 + tiotropium + placebo.
775925|NCT01490125|P1|Participant Flow|QVA149+ Placebo+ Tiotropium|Participants were randomized to sequence QVA149 + placebo + tiotropium.
775926|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775927|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775928|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
776306|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
775931|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775932|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775933|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775934|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775935|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775936|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775937|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775938|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775939|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775940|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775941|NCT01490125|O3|Outcome|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775942|NCT01490125|O2|Outcome|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775943|NCT01490125|O1|Outcome|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775944|NCT01490125|E3|Reported Event|Placebo|Participants received placebo to QVA149 plus placebo to tiotropium during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775945|NCT01490125|E2|Reported Event|Tiotropium + Placebo to QVA149|Participants received tiotropium 18 μg plus placebo to QVA149 during 1 of 3 treatment periods once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775946|NCT01490125|E1|Reported Event|QVA149 + Placebo to Tiotropium|Participants received QVA149 plus placebo to tiotropium during 1 of 3 treatment periods, once a day for 6 weeks. Participants were provided with a salbutamol/albuterol inhaler to use as rescue medication.
775947|NCT01490086|B6|Baseline|Total|Total of all reporting groups
775948|NCT01490086|B5|Baseline|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775949|NCT01490086|B4|Baseline|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775950|NCT01490086|B3|Baseline|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775951|NCT01490086|B2|Baseline|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775952|NCT01490086|B1|Baseline|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775953|NCT01490086|P5|Participant Flow|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775954|NCT01490086|P4|Participant Flow|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775955|NCT01490086|P3|Participant Flow|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775956|NCT01490086|P2|Participant Flow|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775957|NCT01490086|P1|Participant Flow|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775958|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775959|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775960|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775961|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775962|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775963|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775964|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775967|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775968|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775969|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775970|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775971|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775972|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775973|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775974|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775975|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775976|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775977|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775978|NCT01490086|O5|Outcome|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775979|NCT01490086|O4|Outcome|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775980|NCT01490086|O3|Outcome|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775981|NCT01490086|O2|Outcome|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775982|NCT01490086|O1|Outcome|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775983|NCT01490086|E5|Reported Event|Placebo|Participants with acute schizophrenia or schizoaffective disorder receiving Placebo once daily for 28 days.
775984|NCT01490086|E4|Reported Event|Aripiprazole 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of Aripiprazole once daily for 28 days.
775985|NCT01490086|E3|Reported Event|RP5063 50 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 50 mg of RP5063 once daily for 28 days.
775986|NCT01490086|E2|Reported Event|RP5063 30 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 30 mg of RP5063 once daily for 28 days.
775987|NCT01490086|E1|Reported Event|RP5063 15 mg|Participants with acute schizophrenia or schizoaffective disorder receiving 15 mg of RP5063 once daily for 28 days.
775988|NCT01490060|B3|Baseline|Total|Total of all reporting groups
775989|NCT01490060|B2|Baseline|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
775990|NCT01490060|B1|Baseline|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
775991|NCT01490060|P4|Participant Flow|Arm B: Two Doses, Group 2|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
775992|NCT01490060|P3|Participant Flow|Arm B: Two Doses, Group 1|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
775993|NCT01490060|P2|Participant Flow|Arm A: Single Dose, Group 2|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
776033|NCT01489358|P2|Participant Flow|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776309|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
775994|NCT01490060|P1|Participant Flow|Arm A: Single Dose, Group 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2). Dexamethasone IVPB daily for 5 days (12 mg on day 1, and 8 mg on days 2-5) and 5HT3 receptor antagonist as standard of care 30 min prior to chemotherapy. Doxorubicin 25 mg/m^2/day IV continuous infusion for 72 hrs on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2). Mesna: Prior to ifosfamide (Day 1) - 500 mg/m^2 given simultaneously with ifosfamide and then daily CI (Days 1-4 completing infusion on day 4) – 1,500 mg/m^2/day for a total of 6 gm/m^2. The mesna infusion will complete 24 hrs after the last dose of ifosfamide. Ifosfamide: 2.5 g/m^2 IV bolus over 3 hrs on days 1, 2, 3, 4 (total dose: 10 g/m^2). Vincristine: 2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
775995|NCT01490060|O3|Outcome|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
775996|NCT01490060|O2|Outcome|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
775997|NCT01490060|O1|Outcome|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
775998|NCT01490060|E3|Reported Event|Arm B: Two Doses, Day 1 + Day 4|Fosaprepitant 150 mg IV Day 1 + Day 4 of Cycle 1 (Group 1) or Day 1 + Day 4 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
775999|NCT01490060|E2|Reported Event|Arm A: Single Dose, Day 1|Fosaprepitant 150 mg intravenous (IV) Day 1 of Cycle 1 (Group 1) or Day 1 of Cycle 2 (Group 2). Participants Randomized to Group 1 (Fosaprepitant Cycle 1 + No Fosaprepitant Cycle 2) or Group 2 (No Fosaprepitant Cycle 1 + Fosaprepitant Cycle 2).
776000|NCT01490060|E1|Reported Event|Control Cycle (Arm A/Arm B)|Control cycle without fosaprepitant.
776001|NCT01489670|B1|Baseline|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776002|NCT01489670|P1|Participant Flow|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776003|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776004|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776005|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776006|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776007|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776008|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776009|NCT01489670|O1|Outcome|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776010|NCT01489670|E1|Reported Event|Lumigan® 0.01%|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
776011|NCT01489527|B3|Baseline|Total|Total of all reporting groups
776012|NCT01489527|B2|Baseline|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776013|NCT01489527|B1|Baseline|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776014|NCT01489527|P2|Participant Flow|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776015|NCT01489527|P1|Participant Flow|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776016|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776017|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776018|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776019|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776020|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776021|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776022|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776023|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776024|NCT01489527|O2|Outcome|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776025|NCT01489527|O1|Outcome|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776026|NCT01489527|E2|Reported Event|Placebo Administration|Placebo injected intramuscularly into the deltoid or thigh muscle.
776027|NCT01489527|E1|Reported Event|Gardasil Vaccine Administration|Gardasil Vaccine injected intramuscularly into the deltoid or thigh muscle.
776028|NCT01489358|B4|Baseline|Total|Total of all reporting groups
776029|NCT01489358|B3|Baseline|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776030|NCT01489358|B2|Baseline|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776031|NCT01489358|B1|Baseline|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776032|NCT01489358|P3|Participant Flow|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776034|NCT01489358|P1|Participant Flow|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776035|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776036|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776037|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776038|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776039|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776040|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776041|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776042|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776043|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776044|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776045|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776046|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776047|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776048|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776049|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776050|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776051|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776052|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776053|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776054|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776055|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776056|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776057|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776058|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776059|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776060|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776061|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776062|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776063|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776064|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776065|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776066|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776067|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776068|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776169|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776069|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776070|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776071|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776072|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776073|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776074|NCT01489358|O3|Outcome|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776075|NCT01489358|O2|Outcome|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776076|NCT01489358|O1|Outcome|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776077|NCT01489358|E3|Reported Event|Group 3: 40 mcg VRC-CHKVLP059-00-VP|Group 3 subjects received 40 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776078|NCT01489358|E2|Reported Event|Group 2: 20 mcg VRC-CHKVLP059-00-VP|Group 2 subjects received 20 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776079|NCT01489358|E1|Reported Event|Group 1: 10 mcg VRC-CHKVLP059-00-VP|Group 1 subjects received 10 mcg of a Virus-Like Particle (VLP) Chikungunya Vaccine, VRC-CHKVLP059-00-VP, on Days 0, 28, and 140
776080|NCT01489254|B4|Baseline|Total|Total of all reporting groups
776081|NCT01489254|B3|Baseline|Placebo|Placebo (daily) for 9 months
776082|NCT01489254|B2|Baseline|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
776083|NCT01489254|B1|Baseline|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
776084|NCT01489254|P4|Participant Flow|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
776085|NCT01489254|P3|Participant Flow|Placebo|Placebo (daily) for 9 months
776086|NCT01489254|P2|Participant Flow|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
776087|NCT01489254|P1|Participant Flow|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
776088|NCT01489254|O3|Outcome|Placebo|Placebo (daily) for 9 months
776089|NCT01489254|O2|Outcome|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months
776090|NCT01489254|O1|Outcome|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months
776091|NCT01489254|E4|Reported Event|Extension Glatiramer 20 mg|Glatiramer acetate (GTR) 20 mg daily for 15 months, open-label extension
776092|NCT01489254|E3|Reported Event|Placebo|Placebo (daily) for 9 months, double-blind
776093|NCT01489254|E2|Reported Event|Copaxone 20 mg|Glatiramer Acetate (Copaxone) 20 mg daily for 9 months, double-blind
776094|NCT01489254|E1|Reported Event|Glatiramer 20 mg|Glatiramer Acetate (GTR) 20 mg daily for 9 months, double-blind
776095|NCT01489189|B3|Baseline|Total|Total of all reporting groups
776096|NCT01489189|B2|Baseline|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776097|NCT01489189|B1|Baseline|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776098|NCT01489189|P2|Participant Flow|Prompt PRP|"Panretinal Photocoagulation (PRP). PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776099|NCT01489189|P1|Participant Flow|Anti-VEGF+Deferred PRP|"Anti vascular endothelial growth factor (Anti-VEGF). Panretinal photocoagulation (PRP). Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776100|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776101|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776102|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776103|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776104|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776184|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776307|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
776105|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776106|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776107|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776108|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776109|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776110|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776111|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776112|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776113|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776114|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776115|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776116|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776117|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776118|NCT01489189|O2|Outcome|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776119|NCT01489189|O1|Outcome|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776120|NCT01489189|E3|Reported Event|Prompt PRP|"PRP= Panretinal Photocoagulation. PRP alone.~Prompt Panretinal Photocoagulation: Panretinal photocoagulation alone at baseline (full session completed within 56 days)."
776121|NCT01489189|E2|Reported Event|Anti-VEGF+Deferred PRP|"Anti-VEGF= Anti vascular endothelial growth factor. PRP= Panretinal photocoagulation. Intravitreal anti-VEGF with PRP only if indicated.~0.5-mg Ranibizumab: Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.~Deferred panretinal photocoagulation: PRP is deferred until failure/futility criteria for intravitreal injection are met."
776122|NCT01489189|E1|Reported Event|Bilateral Participants|Participants with one eye enrolled in each arm of the study.
776123|NCT01488994|B3|Baseline|Total|Total of all reporting groups
776124|NCT01488994|B2|Baseline|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to <12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776215|NCT01488877|P2|Participant Flow|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776216|NCT01488877|P1|Participant Flow|PF-03882845 Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776217|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776218|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
776125|NCT01488994|B1|Baseline|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776126|NCT01488994|P2|Participant Flow|Pediatric Participants 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776127|NCT01488994|P1|Participant Flow|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776128|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776129|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776130|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776131|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776132|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776133|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776134|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776135|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776136|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776137|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776138|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
798906|NCT01401647|B4|Baseline|Total|Total of all reporting groups
776139|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776140|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776141|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776142|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776143|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776144|NCT01488994|O1|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776145|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776146|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776147|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776148|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776149|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776150|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776151|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776152|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776153|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776154|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776219|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776220|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
776155|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776156|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776157|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776158|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776159|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776160|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776161|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776162|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776163|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776164|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776165|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776166|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776167|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776168|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776381|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
776170|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776171|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776172|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776173|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776174|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776175|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776176|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776177|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776178|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776179|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776180|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776181|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776182|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776183|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776382|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
776185|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776186|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776187|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
776188|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776189|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776190|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
776191|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776192|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776193|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
776194|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776195|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776196|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
776197|NCT01488994|O2|Outcome|BAX326 6 to <12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776221|NCT01488877|O1|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776222|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776308|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
776198|NCT01488994|O1|Outcome|BAX326 < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776199|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
776200|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776201|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776202|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
776203|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776204|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776205|NCT01488994|O3|Outcome|Pharmacokinetic Full Analysis Set|Comprised of all participants who had at least one plasma factor IX activity level available during post-infusion timepoints after infusion of study product.
776206|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776207|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776208|NCT01488994|O1|Outcome|Overall Study Arm|No participants
776209|NCT01488994|O3|Outcome|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776210|NCT01488994|O2|Outcome|Pediatric Participants 6 to < 12 Years of Age|Pediatric participants 6 to < 12 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776211|NCT01488994|O1|Outcome|Pediatric Participants < 6 Years of Age|Pediatric participants < 6 years of age. All pediatric participants underwent pharmacokinetic (PK) assessment followed by prophylactic treatment with the study product. All participants received the same dosing schedule of study product during the study. After a washout period of 5-7 days, participants received an initial infusion of study product at a dose of 75±5 IU/kg for the PK assessment. For the prophylactic regimen, participants were treated with the recommended dose of 50 IU/kg of study product twice weekly ranging from 40-80 IU/kg for 26±1 weeks or for at least 50 EDs to study product, whichever occurred last.
776212|NCT01488994|E1|Reported Event|Full Analysis Set|Comprised of all participants who received at least one infusion of study product
776213|NCT01488877|B1|Baseline|Entire Study Population|All participants who were enrolled in this study.
776214|NCT01488877|P3|Participant Flow|Spironolactone Placebo|Similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
776223|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
776224|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776225|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
776226|NCT01488877|O2|Outcome|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776227|NCT01488877|O1|Outcome|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
776228|NCT01488877|E2|Reported Event|PF-03882845 3 mg|PF-03882845 3 mg tablet in Cohort 1, orally once daily up to Day 14.
776229|NCT01488877|E1|Reported Event|Placebo|Placebo matched to PF-03882845 3 mg tablet in Cohort 1 or similar-looking placebo matched to spironolactone 25 mg tablet in Cohort 4, orally once daily up to Day 14.
776230|NCT01488578|B1|Baseline|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
776231|NCT01488578|P1|Participant Flow|Tolterodine Tartrate|Participants taking Tolterodine tartrate.
776232|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
776233|NCT01488578|O2|Outcome|Without Previous Treatment|Participants without previous treatment of OAB who took tolterodine according to Japanese Package Insert.
776234|NCT01488578|O1|Outcome|With Previous Treatment|Participants with previous treatment of OAB who took tolterodine according to Japanese Package Insert.
776235|NCT01488578|O3|Outcome|>= 5 Episodes|Participants with >= 5 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
776236|NCT01488578|O2|Outcome|3 to 4 Episodes|Participants with 3 or 4 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
776237|NCT01488578|O1|Outcome|1 to 2 Episodes|Participants with 1 or 2 urinary incontinence episodes per day who took tolterodine according to Japanese Package Insert.
776238|NCT01488578|O4|Outcome|>= 3 Urinations|Participants with >= 3 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
776239|NCT01488578|O3|Outcome|2 Urinations|Participants with 2 times urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
776240|NCT01488578|O2|Outcome|1 Urination|Participants with 1 time urination per day (during sleep)who took tolterodine according to Japanese Package Insert.
776241|NCT01488578|O1|Outcome|No Urination|Participants with no urination who took tolterodine according to Japanese Package Insert.
776242|NCT01488578|O2|Outcome|Without Urinary Urgency|Participants without urinary urgency who took tolterodine according to Japanese Package Insert.
776243|NCT01488578|O1|Outcome|With Urinary Urgency|Participants with urinary urgency who took tolterodine according to Japanese Package Insert.
776244|NCT01488578|O3|Outcome|Severe|Participants with severe OAB who took tolterodine according to Japanese Package Insert.
776245|NCT01488578|O2|Outcome|Moderate|Participants with moderate OAB who took tolterodine according to Japanese Package Insert.
776246|NCT01488578|O1|Outcome|Mild|Participants with mild OAB who took tolterodine according to Japanese Package Insert.
776247|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
776248|NCT01488578|O2|Outcome|Without BPH|Participants without complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
776249|NCT01488578|O1|Outcome|With BPH|Participants with complication of benign prostatic hypertrophy who took tolterodine according to Japanese Package Insert.
776250|NCT01488578|O2|Outcome|>=65 Years|Participants with >= 65 years who took tolterodine according to Japanese Package Insert.
776251|NCT01488578|O1|Outcome|<65 Years|Participants with < 65 years who took tolterodine according to Japanese Package Insert.
776252|NCT01488578|O2|Outcome|Without Complications|Participants without complications who took tolterodine according to Japanese Package Insert.
776253|NCT01488578|O1|Outcome|With Complications|Participants with complications who took tolterodine according to Japanese Package Insert.
776254|NCT01488578|O2|Outcome|Female|Female participants who took tolterodine according to Japanese Package Insert.
776255|NCT01488578|O1|Outcome|Male|Male participants who took tolterodine according to Japanese Package Insert.
776256|NCT01488578|O2|Outcome|Without Non-drug Therapies|Participants without non-drug therapies who took tolterodine according to Japanese Package Insert.
776257|NCT01488578|O1|Outcome|With Non-drug Therapies|Participants with non-drug therapies who took tolterodine according to Japanese Package Insert.
776258|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
776259|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
776260|NCT01488578|O2|Outcome|Without Concomitant Drugs|Participants without concomitant drugs who took tolterodine according to Japanese Package Insert.
776261|NCT01488578|O1|Outcome|With Concomitant Drugs|Participants with concomitant drugs who took tolterodine according to Japanese Package Insert.
776262|NCT01488578|O1|Outcome|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
776263|NCT01488578|E1|Reported Event|Tolterodine Tartrate|Participants taking Tolterodine tartrate according to Japanese Package Insert.
776264|NCT01488487|B1|Baseline|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
776302|NCT01488409|O1|Outcome|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
776303|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
776265|NCT01488487|P1|Participant Flow|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
776266|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
776267|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
776268|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
776269|NCT01488487|O1|Outcome|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
776270|NCT01488487|E1|Reported Event|Everolimus + Pasireotide|"Oral Everolimus 7.5 mg administered daily for 28 days per cycle, plus pasireotide LAR 60 mg administered by intramuscular injection once per 28 day cycle on day 1.~Everolimus: Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.~Pasireotide: Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity."
776271|NCT01488448|B3|Baseline|Total|Total of all reporting groups
776272|NCT01488448|B2|Baseline|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776273|NCT01488448|B1|Baseline|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776274|NCT01488448|P2|Participant Flow|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776275|NCT01488448|P1|Participant Flow|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776276|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776277|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776278|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776279|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776280|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776281|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776282|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776283|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776284|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776285|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776286|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776287|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776288|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776289|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776290|NCT01488448|O2|Outcome|Nebulized Normal Saline|"4 mL nebulized 0.9% sodium chloride every 4 hours until discharge~0.9% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
776291|NCT01488448|O1|Outcome|Nebulized Hypertonic Saline|"4mL nebulized 3% sodium chloride every 4 hours until discharge~3% sodium chloride: 4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge"
776292|NCT01488448|O2|Outcome|Normal Saline|4 mL nebulized 0.9% sodium chloride every 4 hours until discharge
776293|NCT01488448|O1|Outcome|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776294|NCT01488448|E2|Reported Event|Normal Saline|4mL nebulized 0.9% sodium chloride every 4 hours until discharge
776295|NCT01488448|E1|Reported Event|Hypertonic Saline|4 mL nebulized 3% sodium chloride every 4 hours until discharge
776296|NCT01488409|B3|Baseline|Total|Total of all reporting groups
776297|NCT01488409|B2|Baseline|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
776298|NCT01488409|B1|Baseline|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
776299|NCT01488409|P2|Participant Flow|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
776300|NCT01488409|P1|Participant Flow|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
776301|NCT01488409|O2|Outcome|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
776311|NCT01488409|E2|Reported Event|Placebo|"Treatment with Placebo control.~Placebo: 0 mg by mouth (PO) three times daily"
776312|NCT01488409|E1|Reported Event|Acipimox|"Treatment with the study drug Acipimox~Acipimox: 250 mg by mouth (PO) three times daily"
776313|NCT01488370|B4|Baseline|Total|Total of all reporting groups
776314|NCT01488370|B3|Baseline|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776315|NCT01488370|B2|Baseline|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776316|NCT01488370|B1|Baseline|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776317|NCT01488370|P3|Participant Flow|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776318|NCT01488370|P2|Participant Flow|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776319|NCT01488370|P1|Participant Flow|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776320|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776321|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776322|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776323|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776324|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776325|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776326|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776327|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776328|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776329|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776330|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776331|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776332|NCT01488370|O3|Outcome|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776333|NCT01488370|O2|Outcome|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776334|NCT01488370|O1|Outcome|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776335|NCT01488370|E3|Reported Event|Standard Laryngoscope|"A device for endotracheal intubation~Endotracheal intubation: Endotracheal intubation"
776336|NCT01488370|E2|Reported Event|Storz|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776337|NCT01488370|E1|Reported Event|Glidescope|"A device for endotracheal intubation.~Endotracheal intubation: Endotracheal intubation"
776338|NCT01488188|B3|Baseline|Total|Total of all reporting groups
776339|NCT01488188|B2|Baseline|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
776340|NCT01488188|B1|Baseline|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
776341|NCT01488188|P2|Participant Flow|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
776342|NCT01488188|P1|Participant Flow|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
776343|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
776344|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
776345|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
776346|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
776347|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
776348|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
776349|NCT01488188|O2|Outcome|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
776350|NCT01488188|O1|Outcome|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
776351|NCT01488188|E2|Reported Event|Influenza Vaccine-Nasal|"Nasal administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by nasal route"
776352|NCT01488188|E1|Reported Event|Influenza Vaccine -Sublingual|"Sublingual administration~Influenza vaccine : Administration of 1 dose (0.2 ml) by sublingual route"
776353|NCT01488097|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776372|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
799149|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
776383|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
776384|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
776354|NCT01488097|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776355|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776356|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776357|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776358|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776359|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776360|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776361|NCT01488097|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776362|NCT01488097|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa. Each subject initiated treatment in this extension study at the once weekly (qw) dose of sebelipase alfa that he/she received in study LAL-CL01 (0.35, 1, or 3 mg/kg qw). After 4 initial weekly doses, subjects transitioned to every other week (qow) dosing at either 1 mg/kg (subjects who initiated treatment at 0.35 or 1 mg/kg qw) or 3 mg/kg (subjects who initiated dosing at 3 mg/kg qw). In the event of disease progression (based on protocol defined criteria) after at least 12 weeks of treatment in this study, subjects could be considered for a dose increase to 3 mg/kg qow (from 1 mg/kg qow) or to 3 mg/kg qw (from 3 mg/kg qow).
776363|NCT01488071|B3|Baseline|Total|Total of all reporting groups
776364|NCT01488071|B2|Baseline|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
776365|NCT01488071|B1|Baseline|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
776366|NCT01488071|P2|Participant Flow|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
776367|NCT01488071|P1|Participant Flow|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
776368|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
776369|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
776370|NCT01488071|O2|Outcome|Agomelatine 25 mg or 50 mg|encapsulated tablets, daily, orally
776371|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
799150|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
776395|NCT01488071|O1|Outcome|Vortioxetine 10 mg or 20 mg|encapsulated tablets, daily, orally
776396|NCT01488071|E2|Reported Event|Agomelatine|
776397|NCT01488071|E1|Reported Event|Vortioxetine|
776398|NCT01488019|B3|Baseline|Total|Total of all reporting groups
776399|NCT01488019|B2|Baseline|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776400|NCT01488019|B1|Baseline|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20mcg/2 mL, twice daily nebulization for 52 weeks"
776401|NCT01488019|P2|Participant Flow|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776402|NCT01488019|P1|Participant Flow|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776403|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776404|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776405|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776406|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776407|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776408|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776409|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist-Placebo: Placebo vehicle, 2mL, twice daily for 52 weeks"
776410|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist, nebulization, COPD: Perforomist, 20 mcg/2 mL, twice daily for 52 weeks"
776411|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776412|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776413|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776414|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776415|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776416|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776417|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776418|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776419|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776420|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776421|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776422|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776423|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776424|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776425|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776426|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776427|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776428|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776429|NCT01488019|O2|Outcome|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776430|NCT01488019|O1|Outcome|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776431|NCT01488019|E2|Reported Event|Matching Placebo|"Placebo~Perforomist Matching Placebo: placebo vehicle, 2mL, twice daily nebulization for 52 weeks"
776432|NCT01488019|E1|Reported Event|Perforomist Inhalation Solution|"Active~Perforomist Inhalation Solution, 20 mcg/2 mL, twice daily nebulization for 52 weeks"
776433|NCT01487954|B3|Baseline|Total|Total of all reporting groups
776465|NCT01487577|P1|Participant Flow|Mycophenolate Mofetil|Pharmacokinetics-based targeting of Mycophenolate mofetil
776434|NCT01487954|B2|Baseline|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776435|NCT01487954|B1|Baseline|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776468|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776658|NCT01486043|E1|Reported Event|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
776436|NCT01487954|P2|Participant Flow|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776437|NCT01487954|P1|Participant Flow|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776438|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776439|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776440|NCT01487954|O2|Outcome|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776441|NCT01487954|O1|Outcome|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776442|NCT01487954|E2|Reported Event|Arm II: Distilled Water|"Patients undergo external beam radiation therapy as in arm I. Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy~distilled water: Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776443|NCT01487954|E1|Reported Event|Arm I: Alkaline Water|"Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks. Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~alkaline water: Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.~external beam radiation therapy (EBRT): Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks."
776444|NCT01487863|B3|Baseline|Total|Total of all reporting groups
776445|NCT01487863|B2|Baseline|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776446|NCT01487863|B1|Baseline|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death, occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776447|NCT01487863|P2|Participant Flow|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776495|NCT01486966|B3|Baseline|Total|Total of all reporting groups
776614|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776448|NCT01487863|P1|Participant Flow|Concurrent Arm|"Subjects received sipuleucel-T with concurrent abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776469|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776449|NCT01487863|O2|Outcome|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776450|NCT01487863|O1|Outcome|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776451|NCT01487863|E2|Reported Event|Sequential Arm|"Subjects received sipuleucel-T therapy followed by abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone started at week 10 from the start of the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776452|NCT01487863|E1|Reported Event|Concurrent Arm|"Subjects received sipuleucel-T concurrent with abiraterone acetate plus prednisone. Abiraterone acetate plus prednisone treatment started the next day after the first infusion of sipuleucel-T and continued for 26 weeks or until disease progression, unacceptable toxicity, or death occurred.~sipuleucel-T: Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).~abiraterone acetate: Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks."
776453|NCT01487668|B3|Baseline|Total|Total of all reporting groups
776454|NCT01487668|B2|Baseline|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
776455|NCT01487668|B1|Baseline|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
776456|NCT01487668|P2|Participant Flow|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
776457|NCT01487668|P1|Participant Flow|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
776458|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages
776459|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
776460|NCT01487668|O2|Outcome|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
776461|NCT01487668|O1|Outcome|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
776462|NCT01487668|E2|Reported Event|Arm 2 (Life Goals Collaborative Care)|Life Goals Collaborative Care: LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
776463|NCT01487668|E1|Reported Event|Arm 1 (Usual Care)|Usual care will include standard mental health and medical care available in the VA clinics but with no active management by the LGCC health specialist.
776464|NCT01487577|B1|Baseline|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776466|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776467|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776556|NCT01486758|P2|Participant Flow|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776470|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776471|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776472|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776473|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776474|NCT01487577|O1|Outcome|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776475|NCT01487577|E1|Reported Event|Mycophenolate Mofetil|"Pharmacokinetics-based targeting of mycophenolate mofetil~Mycophenolate mofetil: Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure"
776476|NCT01487525|B3|Baseline|Total|Total of all reporting groups
776477|NCT01487525|B2|Baseline|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
776478|NCT01487525|B1|Baseline|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
776479|NCT01487525|P2|Participant Flow|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
776480|NCT01487525|P1|Participant Flow|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
776481|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
776482|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
776483|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
776484|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
776485|NCT01487525|O2|Outcome|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
776486|NCT01487525|O1|Outcome|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
776487|NCT01487525|E2|Reported Event|PBFR+|"strength training exercise with partial blood flow restriction~double leg press with partial blood flow restriction: double leg press extension with application of partial blood flow restriction to the upper leg"
776488|NCT01487525|E1|Reported Event|PBFR-|"strength training exercise without partial blood flow restriction~double leg press without partial blood flow restriction: double leg press extension without application of partial blood flow restriction to the upper leg"
776489|NCT01487499|B1|Baseline|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
776490|NCT01487499|P1|Participant Flow|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
776491|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
776492|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
776493|NCT01487499|O1|Outcome|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
776494|NCT01487499|E1|Reported Event|Patients With Limited Stage SCLC|"Subjects with limited stage SCLC treated sequentially with cisplatin.~Cisplatin: 40 mg in 40 mL of normal saline for each of 4 bronchoscopies"
776496|NCT01486966|B2|Baseline|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776497|NCT01486966|B1|Baseline|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776498|NCT01486966|P2|Participant Flow|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776499|NCT01486966|P1|Participant Flow|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776500|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776501|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776502|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776503|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776504|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776505|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776506|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776507|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776508|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776509|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776510|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776511|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776512|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776513|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776514|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776515|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776516|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776517|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776518|NCT01486966|O2|Outcome|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776519|NCT01486966|O1|Outcome|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776520|NCT01486966|E2|Reported Event|Insulin NPH + Human Soluble Insulin ± Metformin|Insulin NPH was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Human Soluble insulin was injected in the abdominal area subcutaneously 30 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776521|NCT01486966|E1|Reported Event|Insulin Detemir + Insulin Aspart ± Metformin|Insulin detemir was administered subcutaneously in the thigh once daily at bedtime as basal insulin. Insulin aspart was injected in the abdominal area subcutaneously 0~5 minutes before each meal as bolus insulin. Metformin was given to subjects who were taking metformin before this trial.
776522|NCT01486927|B1|Baseline|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
776523|NCT01486927|P1|Participant Flow|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover pharmacokinetic [PK] analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 exposure days (EDs). In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
776524|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776525|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776526|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776527|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776528|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776529|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776530|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776531|NCT01486927|O1|Outcome|rVIII-SingleChain PK Population (Part 3)|The rVIII-SingleChain PK population (Part 3) consisted of subjects who received rVIII-SingleChain during Part 3 of the study (initial and repeat dose) and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In Part 3, 64 subjects participated in the initial PK, of whom 30 also participated in the repeat PK.
776613|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776532|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least one dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
776533|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
776534|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
776557|NCT01486758|P1|Participant Flow|Placebo|Placebo for 14 days.
776535|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
776536|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
776537|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776538|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776539|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776540|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776541|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776542|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776543|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776544|NCT01486927|O1|Outcome|PK Population (Part 1)|The PK population (Part 1) consisted of subjects who had received 1 dose of 50 IU/kg of rVIII-SingleChain and for whom a sufficient number of analyzable PK samples were obtained to permit the evaluation of the PK profile. In the Part 1 PK analysis, these subjects also received 1 dose of 50 IU/kg octocog alfa. There were 27 subjects in the PK population (Part 1).
776545|NCT01486927|O1|Outcome|rVIII-SingleChain Surgical|The rVIII-SingleChain Surgical group included all subjects enrolled in the surgical sub-study who received at least 1 dose of rVIII-SingleChain during the surgical sub-study. There were 13 subjects in the rVIII-SingleChain Surgical group.
776546|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
776547|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
776548|NCT01486927|O1|Outcome|Recombinant Factor VIII (rFVIII)|In Part 1 of the study (a single-sequence crossover PK analysis), 27 subjects received a single injection of octocog alfa followed by a single injection of rVIII-SingleChain. Twenty-six of the 27 subjects from Part 1 then entered Part 2 of the study where they were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs. In Part 3 of the study, 148 additional subjects were enrolled and were assigned either to an on-demand or prophylaxis regimen with repeat injections of rVIII-SingleChain until they reached 50 EDs; 64 of these subjects participated in additional PK analyses. Overall, 174 subjects received rVIII-SingleChain as either on-demand or prophylaxis regimens, and 13 subjects participated in the surgical substudy.
776549|NCT01486927|O3|Outcome|rVIII-SingleChain|The Efficacy population consisted of all subjects who received at least 1 dose of rVIII-SingleChain as part of either routine prophylaxis treatment or on-demand treatment during Parts 2 or 3 of the study. There were 173 subjects in the Efficacy population.
776550|NCT01486927|O2|Outcome|rVIII-SingleChain Prophylaxis|The rVIII-SingleChain Prophylaxis group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of routine prophylaxis treatment during Parts 2 or 3 of the study. There were 146 subjects in the rVIII-SingleChain Prophylaxis group.
776551|NCT01486927|O1|Outcome|rVIII-SingleChain On-demand|The rVIII-SingleChain On-demand group consisted of all subjects in the efficacy population who received at least 1 dose rVIII-SingleChain as part of on-demand treatment during Parts 2 or 3 of the study. There were 27 subjects in the rVIII-SingleChain On-demand group.
776552|NCT01486927|E1|Reported Event|Safety Population|The Safety Population comprised all subjects treated with rVIII-SingleChain.
776553|NCT01486758|B3|Baseline|Total|Total of all reporting groups
776554|NCT01486758|B2|Baseline|Placebo|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776555|NCT01486758|B1|Baseline|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776659|NCT01485991|B3|Baseline|Total|Total of all reporting groups
776558|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776559|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
776560|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776561|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
776562|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776563|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
776564|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776565|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
776566|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776567|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
776568|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776569|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
776570|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776571|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days.
776572|NCT01486758|O2|Outcome|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776573|NCT01486758|O1|Outcome|Placebo|Placebo for 14 days
776574|NCT01486758|E2|Reported Event|Azithromycin|Azithromycin: Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
776575|NCT01486758|E1|Reported Event|Placebo|Placebo for 14 days.
776576|NCT01486615|B5|Baseline|Total|Total of all reporting groups
776577|NCT01486615|B4|Baseline|Placebo|premedication 1-2 hr prior to anesthesia
776578|NCT01486615|B3|Baseline|Alprazolam|premedication 1-2 hr prior to anesthesia
776579|NCT01486615|B2|Baseline|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
776580|NCT01486615|B1|Baseline|Melatonin|premedication 1-2 hour prior to anesthesia
776581|NCT01486615|P4|Participant Flow|Placebo|Oral premedication with a similar looking placebo tablet 1-2 hr prior to anesthesia
776582|NCT01486615|P3|Participant Flow|Alprazolam|Oral premedication with 0.5 mg alprazolam (Alprax) 1-2 hr prior to anesthesia
776583|NCT01486615|P2|Participant Flow|Melatonin and Alprazolam|Oral premedication with a 3 mg melatonin and 0.5 mg alprazolam combination tablet (Stressnil) 1-2 hrs prior to anesthesia
776584|NCT01486615|P1|Participant Flow|Melatonin|Oral premedication with 3 mg melatonin tablet (Meloset) 1-2 hour prior to anesthesia
776585|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776586|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776587|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776588|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776589|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776590|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776591|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776592|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776593|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776594|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776595|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776596|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776597|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776598|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776599|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776600|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776601|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776602|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776603|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776604|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776605|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776606|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776607|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776608|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776609|NCT01486615|O4|Outcome|Placebo|premedicated 1-2 hours before anesthesia
776610|NCT01486615|O3|Outcome|Alprazolam|premedicated 1-2 hours before anesthesia
776611|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776612|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776615|NCT01486615|O2|Outcome|Melatonin and Alprazolam|premedicated 1-2 hrs before anesthesia
776616|NCT01486615|O1|Outcome|Melatonin|premedicated 1-2 hour before anesthesia
776617|NCT01486615|E4|Reported Event|Placebo|premedication 1-2 hr prior to anesthesia
776618|NCT01486615|E3|Reported Event|Alprazolam|premedication 1-2 hr prior to anesthesia
776619|NCT01486615|E2|Reported Event|Melatonin and Alprazolam|premedicated 1-2 hrs prior to anesthesia
776620|NCT01486615|E1|Reported Event|Melatonin|premedication 1-2 hour prior to anesthesia
776621|NCT01486446|B3|Baseline|Total|Total of all reporting groups
776622|NCT01486446|B2|Baseline|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776623|NCT01486446|B1|Baseline|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
817967|NCT01333501|B3|Baseline|Total|Total of all reporting groups
776624|NCT01486446|P2|Participant Flow|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776625|NCT01486446|P1|Participant Flow|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776626|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776627|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776628|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776629|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776630|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776631|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776632|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776633|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776634|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776635|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776636|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776637|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776638|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776639|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776640|NCT01486446|O2|Outcome|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776641|NCT01486446|O1|Outcome|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776642|NCT01486446|E2|Reported Event|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
776643|NCT01486446|E1|Reported Event|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
776644|NCT01486238|B3|Baseline|Total|Total of all reporting groups
776645|NCT01486238|B2|Baseline|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
776646|NCT01486238|B1|Baseline|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
776647|NCT01486238|P2|Participant Flow|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
776648|NCT01486238|P1|Participant Flow|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
776649|NCT01486238|O2|Outcome|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
776650|NCT01486238|O1|Outcome|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
776651|NCT01486238|E2|Reported Event|IVMac q4 Arm|Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Macugen® injection will be administered as described in the package insert.
776652|NCT01486238|E1|Reported Event|IVMac q6 Arm|Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6week intervals beginning on Day 0 and ending at Week 18. Macugen® injection will be administered as described in the package insert.
776653|NCT01486043|B1|Baseline|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
776654|NCT01486043|P1|Participant Flow|Metformin and Insulin Therapy|"For the prospectively recruited arm (metformin plus insulin therapy), a total of 4 subjects were recruited. Two subjects were withdrawn from the study after laboratory studies revealed liver enzymes (AST) levels that were above that allowed for the study at the time. An additional 2 subjects were recruited in the study.~For the retrospective chart review portion of our study, 12 patients were included after conducting chart review of cases from January 2007 to August 2011."
776655|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
776656|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
776657|NCT01486043|O1|Outcome|Metformin and Insulin Therapy|Patients receiving metformin and insulin therapy.
776660|NCT01485991|B2|Baseline|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
776661|NCT01485991|B1|Baseline|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
776662|NCT01485991|P2|Participant Flow|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
776663|NCT01485991|P1|Participant Flow|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
776664|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
776665|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
776666|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
776667|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
776668|NCT01485991|O2|Outcome|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
776669|NCT01485991|O1|Outcome|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
776670|NCT01485991|E2|Reported Event|Telaprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|2 Telaprevir (TVR) tablets, orally, 3 times a day along with 150 mg TMC435 matched placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks.
776671|NCT01485991|E1|Reported Event|Simeprevir+Placebo+Peginterferon Alfa-2a+Ribavirin|Simeprevir (TMC435) 150 milligram (mg) capsule, orally, once daily for 12 weeks, along with 2 telaprevir (TVR) matched placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
776672|NCT01485887|B1|Baseline|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776673|NCT01485887|P1|Participant Flow|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776674|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776675|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776713|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
776714|NCT01485536|O1|Outcome|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
776715|NCT01485536|E1|Reported Event|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
776676|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776677|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776678|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776679|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776680|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776681|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776682|NCT01485887|O1|Outcome|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776706|NCT01485640|B1|Baseline|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
776707|NCT01485640|P1|Participant Flow|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
776683|NCT01485887|E1|Reported Event|Venlafaxine ER 75-225 mg/Day Flexible|Participants orally received venlafaxine ER once daily after dinner or breakfast at a dosage within the predetermined range (75, 150, and 225 mg/day). Participants commenced venlafaxine ER treatment at the dosage of 37.5 mg/day, and after 1 week, increased the dosage to 75 mg/day and continued treatment for 1 week. If no tolerability issue was observed after 2 weeks by the judgment of the investigators, the dosage was increased to 150 mg/day and continued for 1 week. Furthermore, if no tolerability issue was observed after 3 weeks by the judgment of the investigators, the dosage was increased to 225 mg/day. Participants were able to remain at the same dose by the judgment of investigators if there was any tolerability concern from dose escalation. In addition, dose reduction was allowed upon occurrence of tolerability concern following dose escalation.
776684|NCT01485796|B1|Baseline|Subcutaneous Treatment With IGI, 10% and rHuPH20|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
776685|NCT01485796|P1|Participant Flow|Subcutaneous Treatment With IGI, 10% and rHuPH20|Subcutaneous treatment with IGI, 10% and rHuPH20 occurred in 2 study epochs. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up. During the safety-follow up, subjects received IGI, 10% by either the IV or the SC route.
776686|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
776687|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776688|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776689|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776690|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776691|NCT01485796|O1|Outcome|Epoch 2 Data Set|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
776692|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776693|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
776694|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776695|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776696|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
776697|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776698|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776699|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
776700|NCT01485796|O1|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
776701|NCT01485796|O2|Outcome|Epoch 2 Data Set (n=36)|The Epoch 2 Data Set comprises all subjects of the safety analysis set who received study drug in Epoch 2.
776702|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776703|NCT01485796|O1|Outcome|Safety Analysis Set (n=37)|The Safety Analysis Set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2.
776704|NCT01485796|E2|Reported Event|Safety Follow-up (n=26)|Treatment with rHuPH20 was stopped as of August 2012 following discussion with the FDA. This decision was based on theoretical risks of exposure to anti-rHuPH20 antibodies, not because of any clinical adverse events. 26 subjects still active in Epoch 2 of the study went into a safety follow-up period and were treated with IGI, 10% (GAMMAGARD LIQUID) either intravenously or subcutaneously.
776705|NCT01485796|E1|Reported Event|Epochs 1+2 (SC Treatment w/ IGI,10% and rHuPH20, n=37)|This analysis set comprises all subjects exposed to study drug in Epoch 1 and Epoch 2. In Epoch 1, PIDD patients that were already on intravenous (IV) or subcutaneous (SC) treatment were treated with IGI, 10% and rHuPH20 subcutaneously, with one 1-week dose and interval and one 2-week dose and interval. Epoch 2 was to consist of approx. 6 months (24 weeks) of IGI, 10% and rHuPH20 treatment. For subjects pretreated IV, this treatment was to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), depending on the subject´s previous IV dosing schedule. For subjects pretreated SC, treatment was also to occur every 3 or 4 weeks (at a 3-week or 4-week dose, respectively), at the discretion of the investigator and subject. However, treatment with rHuPH20 was stopped as of August 2012 following a discussion with the FDA, and subjects still active in Epoch 2 were switched to a safety follow-up (IGI, 10% by IV or SC route).
777692|NCT01481558|O2|Outcome|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
776708|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
776709|NCT01485640|O1|Outcome|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
776710|NCT01485640|E1|Reported Event|Lurasidone|"Lurasidone flexibly dosed~Lurasidone: Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food"
776711|NCT01485536|B1|Baseline|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
776712|NCT01485536|P1|Participant Flow|AUY922|AUY922 starting dose 70 mg/m2 intravenous on Days 1, 8, 15, and 22 of 28 day cycle.
776716|NCT01485380|B1|Baseline|Active Study Arm|"Subjects recruited into this study will be required to undergo two MRI-PET scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
776717|NCT01485380|P1|Participant Flow|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography scans of the brain in addition to high density electroencephalogram acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
776718|NCT01485380|O1|Outcome|Active Study Arm|"Subjects recruited into this study will be required to undergo two magnetic resonance imaging-positron emission tomography (MRI-PET) scans of the brain in addition to high density electroencephalogram (EEG) acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss on consciousness is initially observed. Loss on consciousness will be assayed by specific auditory and verbal stimuli."
776719|NCT01485380|E1|Reported Event|Active Study Arm|"Subjects recruited into this study will be required to undergo two MR-PET scans of the brain in addition to high density EEG acquisition. The first scan will be a baseline scan while the second scan will be performed while dexmedetomidine is being infused.~dexmedetomidine: The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli."
776720|NCT01485172|B7|Baseline|Total|Total of all reporting groups
776721|NCT01485172|B6|Baseline|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776722|NCT01485172|B5|Baseline|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776723|NCT01485172|B4|Baseline|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776724|NCT01485172|B3|Baseline|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776725|NCT01485172|B2|Baseline|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776726|NCT01485172|B1|Baseline|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776727|NCT01485172|P6|Participant Flow|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776744|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776843|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776728|NCT01485172|P5|Participant Flow|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776729|NCT01485172|P4|Participant Flow|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776877|NCT01484912|E1|Reported Event|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776730|NCT01485172|P3|Participant Flow|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776731|NCT01485172|P2|Participant Flow|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776732|NCT01485172|P1|Participant Flow|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776733|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776734|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776735|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776736|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776737|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776738|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776739|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776740|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776741|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776742|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776743|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776745|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776761|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776746|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776747|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776748|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776749|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776750|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776751|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776752|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776753|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776754|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776755|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776756|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776757|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776758|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776759|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776792|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
777828|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
776760|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776762|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776763|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776764|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776765|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776766|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776767|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776768|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776769|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776770|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776771|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776772|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776773|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776774|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776775|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776813|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776776|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776815|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776816|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776777|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776778|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776779|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776780|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776781|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776782|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776783|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776784|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776785|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776786|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776787|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776788|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776789|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776790|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776791|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776793|NCT01485172|O6|Outcome|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776794|NCT01485172|O5|Outcome|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776795|NCT01485172|O4|Outcome|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776796|NCT01485172|O3|Outcome|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776797|NCT01485172|O2|Outcome|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776798|NCT01485172|O1|Outcome|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776799|NCT01485172|E6|Reported Event|Treatment Group F: 24 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, 12 mg/day at Week 6, 16 mg/day at Week 8, 20 mg/day at Week 10, and 24 mg/day at Week 12. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776800|NCT01485172|E5|Reported Event|Treatment Group E: 12 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, 8 mg/day at Week 4, and 12 mg/day at Week 6. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776801|NCT01485172|E4|Reported Event|Treatment Group D: 8 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2, 6 mg/day at Week 3, and 8 mg/day at Week 4. Par. continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776802|NCT01485172|E3|Reported Event|Treatment Group C: 4 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 mg/day, OD for one week. Par. were up-titrated to 4 mg/day at Week 2 and continued this dose up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were down-titrated to 2 mg for 4 days and then switched to placebo for 3 days for down-titration before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776803|NCT01485172|E2|Reported Event|Treatment Group B: 2 mg/Day|Par. were administered a ropinirole PR tablet totalling 2 milligrams per day (mg/day), OD up to Study Week 17. Par. reaching their target dose and completing the maintenance period or withdrawing prematurely were switched to placebo for down-titration for 1 week before completing a Follow-up visit 2 weeks after receiving the last dose of study medication.
776804|NCT01485172|E1|Reported Event|Treatment Group A: Placebo|Participants (par.) were administered a matching Prolonged Release (PR) placebo tablet Once Daily (OD) for up to 17 weeks. Par. completed a Follow-up visit 2 weeks after receiving the last dose of study medication.
776805|NCT01485094|B4|Baseline|Total|Total of all reporting groups
776806|NCT01485094|B3|Baseline|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776807|NCT01485094|B2|Baseline|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
776808|NCT01485094|B1|Baseline|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776809|NCT01485094|P3|Participant Flow|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776810|NCT01485094|P2|Participant Flow|GRT6010|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~GRT6010: Oral solution given once daily."
776811|NCT01485094|P1|Participant Flow|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo: Matching Placebo capsules to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776812|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776814|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776876|NCT01484912|E2|Reported Event|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776817|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776818|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776819|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776820|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776821|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776822|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776823|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776824|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776825|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776826|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776827|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776828|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776829|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776830|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776831|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776832|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776833|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776834|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776835|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776836|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776837|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776838|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776839|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776840|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776841|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776842|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776844|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776845|NCT01485094|O3|Outcome|Pregabalin|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Pregabalin: Over-encapsulated Pregabalin tablets 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776846|NCT01485094|O2|Outcome|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776847|NCT01485094|O1|Outcome|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be treated with acetaminophen.~Matching Placebo to the over-encapsulated pregabalin tablets and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776848|NCT01485094|E3|Reported Event|Pregabalin|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Pregabalin: Pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7."
776849|NCT01485094|E2|Reported Event|GRT6010|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~GRT6010: Oral solution given once daily."
776850|NCT01485094|E1|Reported Event|Matching Placebo|"Oral administration. Pain not sufficiently controlled may be dosed with acetaminophen.~Matching Placebo: Matching Placebo capsules to the Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.~Capsules twice daily on Days 1 to 7. Solution once daily."
776851|NCT01484977|B1|Baseline|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
776852|NCT01484977|P1|Participant Flow|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
776853|NCT01484977|O1|Outcome|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
776854|NCT01484977|E1|Reported Event|Lacosamide|"Lacosamide will be added to levetiracetam while withdrawing the sodium channel blocking antiepileptic drug (AED).~Lacosamide: 50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.~Maximum duration of study drug administration is approximately 23 weeks."
776855|NCT01484951|B1|Baseline|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
776856|NCT01484951|P1|Participant Flow|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
776857|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
776858|NCT01484951|O1|Outcome|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
776859|NCT01484951|E1|Reported Event|AZARGA|Brinzolamide 1% and timolol 0.5% fixed combination eye drops, one drop administered to the study eye(s) twice daily (8:00 am and 8:00 pm) for up to 8 weeks.
776860|NCT01484938|B1|Baseline|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
776861|NCT01484938|P1|Participant Flow|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
776862|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
776863|NCT01484938|O1|Outcome|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
776864|NCT01484938|E1|Reported Event|OPTI-FREE|Multi-purpose contact lens solution used for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses, per protocol-specified regimen.
776865|NCT01484912|B3|Baseline|Total|Total of all reporting groups
776866|NCT01484912|B2|Baseline|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776867|NCT01484912|B1|Baseline|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776868|NCT01484912|P2|Participant Flow|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776869|NCT01484912|P1|Participant Flow|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776870|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776871|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776872|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
778634|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
776873|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776874|NCT01484912|O2|Outcome|Placebo|"Placebo capsule, containing non-active ingredients.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776875|NCT01484912|O1|Outcome|STA-2|"STA-2 250 mg capsule, each containing 100 mg green tea polyphenols.~Two capsules three times daily for 6 weeks, to be administered in a non-fasting state."
776878|NCT01484873|B1|Baseline|Exenatide|exenatide 10 mcg twice daily
776879|NCT01484873|P1|Participant Flow|Exenatide|exenatide 10 mcg twice daily
776880|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
776881|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
776882|NCT01484873|O1|Outcome|Exenatide|Exenatide: Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
776883|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
776884|NCT01484873|O1|Outcome|Exenatide|exenatide 10 mcg twice daily
776885|NCT01484873|E1|Reported Event|Exenatide|exenatide 10 mcg twice daily
776886|NCT01484652|B3|Baseline|Total|Total of all reporting groups
776887|NCT01484652|B2|Baseline|Placebo|2 tablets taken every 12 hours
776888|NCT01484652|B1|Baseline|COV795|2 tablets taken every 12 hours
776889|NCT01484652|P2|Participant Flow|Placebo|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
776890|NCT01484652|P1|Participant Flow|COV795|2 tablets taken every 12 hours at Hour 0, 12, 24, and 36; total of 4 doses
776891|NCT01484652|O2|Outcome|Placebo|2 tablets taken every 12 hours
776892|NCT01484652|O1|Outcome|COV795|2 tablets taken every 12 hours
776893|NCT01484652|E2|Reported Event|Placebo|2 tablets taken every 12 hours
776894|NCT01484652|E1|Reported Event|COV795|2 tablets taken every 12 hours
776895|NCT01484561|B3|Baseline|Total|Total of all reporting groups
776896|NCT01484561|B2|Baseline|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776897|NCT01484561|B1|Baseline|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776898|NCT01484561|P2|Participant Flow|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776899|NCT01484561|P1|Participant Flow|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776900|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776901|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776902|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776903|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776904|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776905|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776906|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776907|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776908|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776909|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776910|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776911|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
777010|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
776912|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776913|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776914|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776915|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776916|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776917|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776918|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776919|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776920|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776921|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776922|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776923|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776924|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776925|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776926|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776927|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776928|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776929|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776930|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776931|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776932|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776933|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776934|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776935|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776936|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776937|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
777011|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
776938|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776939|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776940|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776941|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776942|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776943|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776944|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776945|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776946|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776947|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776948|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776949|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776950|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776951|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776952|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776953|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776954|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776955|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776956|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776957|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776958|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776959|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776960|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776961|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776962|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776963|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
777012|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
776964|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776965|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776966|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776967|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776968|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776969|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776970|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776971|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776972|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776973|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776974|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776975|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776976|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776977|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776978|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776979|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776980|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776981|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776982|NCT01484561|O2|Outcome|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776983|NCT01484561|O1|Outcome|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776984|NCT01484561|E2|Reported Event|Placebo/Placebo|Participants received matching placebo tablets orally for 43 days (up to a maximum of 50 days) in Period 1 immediately followed by matching placebo tablets orally for 29 days (up to a maximum of 36 days)
776985|NCT01484561|E1|Reported Event|CP-690,550/Placebo|Participants received CP-690,550 10 milligram (mg) tablets twice daily (BID) orally for 43 days (up to a maximum of 50 days) in Period 1 (43 days) followed immediately by placebo BID orally for 29 days (up to a maximum of 36 days) in Period 2
776986|NCT01484314|B1|Baseline|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
776987|NCT01484314|P1|Participant Flow|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
776988|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
777013|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
776989|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
776990|NCT01484314|O1|Outcome|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
776991|NCT01484314|E1|Reported Event|Migration Arm|"Administration of eltrombopag to support platelets during chemotherapy~Eltrombopag: 100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy"
776992|NCT01484197|B1|Baseline|All Participants|All participants randomized to one of four treatment sequences.
776993|NCT01484197|P4|Participant Flow|Sequence 4|Treatment Period 1: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
776994|NCT01484197|P3|Participant Flow|Sequence 3|Treatment Period 1: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
776995|NCT01484197|P2|Participant Flow|Sequence 2|Treatment Period 1: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM ) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
776996|NCT01484197|P1|Participant Flow|Sequence 1|Treatment Period 1: 75 µg indacaterol maleate (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 2: placebo to indacterol (lactose blend) + placebo to indacterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 3: placebo to indacaterol (lactose blend) + 75 µg indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. Treatment Period 4: placebo to indacaterol (lactose blend) + 37.5 µg Indacaterol (PulmoSphereTM) delivered via the Concept1 device once daily in the morning for 7 days. All participants took part in a 7 day run-in period. There was a minimum 14 day washout between each treatment period. Participants continued their current treatment with Inhaled corticosteroids. Inhaled short-acting B2-agonist salbutamol was available for use as rescue medication throughout the study.
776997|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
776998|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
776999|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777000|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777001|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777002|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777003|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777004|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777005|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777006|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777007|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777008|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777009|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
799151|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
777014|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777015|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777016|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777017|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777018|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777019|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777020|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777021|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777022|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777023|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777024|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777025|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777026|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777027|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777028|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777029|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777030|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777031|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777032|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777033|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777034|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777035|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777036|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777037|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777038|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777039|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777040|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777041|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777042|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777043|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777044|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777045|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777046|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777047|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777048|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777049|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777050|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777051|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777052|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777053|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777054|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777055|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777056|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777057|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777058|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777059|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777060|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777061|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777062|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777063|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777064|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777065|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777066|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777067|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777068|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777069|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777070|NCT01484197|O4|Outcome|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777071|NCT01484197|O3|Outcome|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777072|NCT01484197|O2|Outcome|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777073|NCT01484197|O1|Outcome|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777074|NCT01484197|E4|Reported Event|Placebo|Placebo to indacterol lactose blend or PulmoSphereTM delivered via the Concept1 device in the morning for 7 days.
777075|NCT01484197|E3|Reported Event|37.5 µg Indacaterol (PoS)|37.5 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device in the morning for 7 days.
777076|NCT01484197|E2|Reported Event|75 µg Indacaterol (PoS)|75 µg indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device daily in the morning for 7 days.
777077|NCT01484197|E1|Reported Event|75 µg Indacaterol (LB)|75 µg indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
777078|NCT01484132|B1|Baseline|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777079|NCT01484132|P1|Participant Flow|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777080|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777081|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777082|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777083|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777084|NCT01484132|O1|Outcome|Composite|Restoration of dental caries with dental composite: Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777085|NCT01484132|E1|Reported Event|Composite|Restoration of dental caries with dental composite: Dental Resin Restoration (bisphenol A diglycidyl ether methacrylate based composite)
777086|NCT01484054|B1|Baseline|All Subjects|All enrolled subjects who received study lenses.
777087|NCT01484054|P2|Participant Flow|EADE/EAPVPDE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A with embedded print and PVP for dark eyes lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
777088|NCT01484054|P1|Participant Flow|EAPVPDE/EADE|etafilcon A with embedded print and PVP for dark eyes lens worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days with a 1-3 day of wash-out time between 2 periods.
777089|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
777090|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
777091|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
777092|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens
777093|NCT01484054|O2|Outcome|EADE|A marketed daily disposable contact lens
777094|NCT01484054|O1|Outcome|EAPVPDE|A daily disposable contact lens.
777095|NCT01484054|E2|Reported Event|EADE|etafilcon a existing, daily disposable contact lens.
777096|NCT01484054|E1|Reported Event|EAPVPDE|etafilcon A material incorporating PVP in the blister packaging solution.
777097|NCT01484041|B1|Baseline|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777098|NCT01484041|P1|Participant Flow|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777099|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777100|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777101|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777523|NCT01482429|B3|Baseline|Total|Total of all reporting groups
777102|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777103|NCT01484041|O1|Outcome|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777104|NCT01484041|E1|Reported Event|Dovitinib Plus Aromatase Inhibitors|"Dovitinib with aromatase inhibitor~Dovitinib: Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest~Aromatase Inhibitors: Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily"
777105|NCT01484028|B1|Baseline|All Subjects|All randomized subjects who worn at least one pair of study lenses.
777106|NCT01484028|P4|Participant Flow|EALE/1DM|etafilcon A for light eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
777107|NCT01484028|P3|Participant Flow|EADE/1DM|etafilcon A for dark eyes worn daily during the first period of 7-9 days then etafilcon A control lens worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
777108|NCT01484028|P2|Participant Flow|1DM/EALE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for light eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
777109|NCT01484028|P1|Participant Flow|1DM/EADE|etafilcon A control lens worn daily during the first period of 7-9 days then etafilcon A for dark eyes worn daily during the second period of 7-9 days, with a 1-3 days of wash-out time between the 2 periods.
777110|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia, two were discontinued between the first and second periods.
777111|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
777112|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lenses to correct myopia.
777113|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
777114|NCT01484028|O2|Outcome|1-DM|A marketed daily disposable contact lens to correct myopia.
777115|NCT01484028|O1|Outcome|EADE/EALE|etafilcon A with embedded print and PVP for dark/light eyes to correct myopia.
777116|NCT01484028|E2|Reported Event|Etafilcon A Control Lenses|A marketed daily disposable contact lens to correct myopia.
777117|NCT01484028|E1|Reported Event|Etafilcon A With PVP for Dark/Light Eyes|A daily disposable contact lens to correct myopia.
777118|NCT01483963|B6|Baseline|Total|Total of all reporting groups
777119|NCT01483963|B5|Baseline|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777120|NCT01483963|B4|Baseline|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777121|NCT01483963|B3|Baseline|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777122|NCT01483963|B2|Baseline|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777123|NCT01483963|B1|Baseline|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777124|NCT01483963|P5|Participant Flow|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777125|NCT01483963|P4|Participant Flow|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777126|NCT01483963|P3|Participant Flow|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777127|NCT01483963|P2|Participant Flow|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777128|NCT01483963|P1|Participant Flow|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777129|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777130|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777131|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777132|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777133|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
799152|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
777134|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777135|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777136|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777137|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777138|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777139|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777140|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777141|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777142|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777143|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777144|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777145|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777146|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777147|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777148|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777149|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777150|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777151|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777152|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777153|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of collagenase clostridium histolyticum (AA4500) 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777154|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777155|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777156|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777157|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777158|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777159|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777160|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777161|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777162|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777163|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777164|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777165|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777166|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777167|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777168|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777169|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777170|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777171|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777172|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777173|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777174|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777175|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777176|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777177|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777178|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777179|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777180|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777181|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777182|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777183|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777184|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777185|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777186|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777187|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777188|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777189|NCT01483963|O5|Outcome|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777190|NCT01483963|O4|Outcome|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777191|NCT01483963|O3|Outcome|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777192|NCT01483963|O2|Outcome|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777193|NCT01483963|O1|Outcome|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777194|NCT01483963|E5|Reported Event|Shoulder Exercises Only|"Home shoulder exercises for 64 days~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777195|NCT01483963|E4|Reported Event|AA4500 0.58 mg/0.5 mL|"Up to 3 injections of AA4500 0.58 mg/0.5 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777196|NCT01483963|E3|Reported Event|AA4500 0.58 mg/1 mL|"Up to 3 injections of AA4500 0.58 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777197|NCT01483963|E2|Reported Event|AA4500 0.58 mg/2 mL|"Up to 3 injections of AA4500 0.58 mg/2 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777198|NCT01483963|E1|Reported Event|AA4500 0.29 mg/1 mL|"Up to 3 injections of AA4500 0.29 mg/1 mL~Shoulder exercises: Home shoulder exercises, minimum of 3 times per day"
777199|NCT01483937|B3|Baseline|Total|Total of all reporting groups
777200|NCT01483937|B2|Baseline|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777201|NCT01483937|B1|Baseline|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777202|NCT01483937|P2|Participant Flow|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777203|NCT01483937|P1|Participant Flow|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777204|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
777205|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
777206|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
777207|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
777208|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
777209|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received usual care physical therapy from vestibular and balance specialists."
777246|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777247|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777210|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|"Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.~Usual care physical therapy plus SEMD: Patients received standard care physical therapy while wearing SEMD. SEMD protocols were provided to device subjects."
777211|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|"Subjects received usual physical therapy intervention provided by vestibular and balance specialists.~Conventional physical therapy only: Subjects received standard care physical therapy from vestibular and balance specialists."
777212|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777213|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777214|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777215|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777216|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777217|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777218|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777219|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777220|NCT01483937|O2|Outcome|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777221|NCT01483937|O1|Outcome|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777222|NCT01483937|E2|Reported Event|Conventional Physical Therapy Plus SEMD|Subjects received usual physical therapy intervention while using SEMD: SEMD protocols augmented conventional physical therapy.
777223|NCT01483937|E1|Reported Event|Conventional Care Physical Therapy Only|Subjects received usual physical therapy intervention provided by vestibular and balance specialists.
777224|NCT01483924|B6|Baseline|Total|Total of all reporting groups
777225|NCT01483924|B5|Baseline|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777226|NCT01483924|B4|Baseline|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777227|NCT01483924|B3|Baseline|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777228|NCT01483924|B2|Baseline|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777229|NCT01483924|B1|Baseline|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777230|NCT01483924|P5|Participant Flow|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777231|NCT01483924|P4|Participant Flow|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777232|NCT01483924|P3|Participant Flow|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777233|NCT01483924|P2|Participant Flow|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777234|NCT01483924|P1|Participant Flow|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777235|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777236|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777237|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777238|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777239|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777240|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777241|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777242|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777243|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777244|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777245|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777555|NCT01482221|P3|Participant Flow|Placebo|Intravenous infusion
777248|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777249|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777250|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
777251|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777252|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
818091|NCT01333397|O3|Outcome|Dysport NG 50 U|
777253|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
777254|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777255|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777256|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777257|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777258|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777259|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777260|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777261|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777262|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777263|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777264|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777265|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777266|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777267|NCT01483924|O4|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777268|NCT01483924|O3|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777269|NCT01483924|O2|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777270|NCT01483924|O1|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777271|NCT01483924|O5|Outcome|Apo805K1 100 mg|Patients in this treatment group received two 50 mg tablets of Apo805K1 daily for 12 weeks
777272|NCT01483924|O4|Outcome|Apo805K1 60 mg|Patients in this treatment group received one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777273|NCT01483924|O3|Outcome|Apo805K1 30 mg|Patients in this treatment group received three 10 mg tablets of Apo805K1 daily for 12 weeks
777274|NCT01483924|O2|Outcome|Apo805K1 10 mg|Patients in this treatment group received a single 10 mg tablet of Apo805K1 daily for 12 weeks
777275|NCT01483924|O1|Outcome|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to receive placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777276|NCT01483924|E5|Reported Event|Apo805K1 100 mg|Patients in this treatment group took two 50 mg tablets of Apo805K1 daily for 12 weeks
777277|NCT01483924|E4|Reported Event|Apo805K1 60 mg|Patients in this treatment group took one 10 mg tablet plus one 50 mg tablet of Apo805K1 daily for 12 weeks
777278|NCT01483924|E3|Reported Event|Apo805K1 30 mg|Patients in this treatment group took three 10 mg tablets of Apo805K1 daily for 12 weeks
777279|NCT01483924|E2|Reported Event|Apo805K1 10 mg|Patients in this treatment group took a single 10 mg tablet of Apo805K1 daily for 12 weeks
777280|NCT01483924|E1|Reported Event|Placebo|Three patients in each of the 4 dose-escalating cohorts were randomized to take placebo tablets that matched the active product in size and number (one 10 mg tablet, three 10 mg tablets, one 50 mg plus one 10 mg tablet, or two 50 mg tablets, respectively), daily for 12 weeks. The data of all placebo recipients were pooled for analyses.
777281|NCT01483820|B1|Baseline|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777282|NCT01483820|P1|Participant Flow|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777283|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777284|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777285|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777286|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777287|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777288|NCT01483820|O1|Outcome|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777289|NCT01483820|E1|Reported Event|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
777290|NCT01483651|B1|Baseline|All Study Participants|Regular insulin given at each of three study visits with a different infusion rate at each visit, either low, medium or high insulin infusion with glucagon administration.
777291|NCT01483651|P6|Participant Flow|High, Medium and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
777524|NCT01482429|B2|Baseline|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
777292|NCT01483651|P5|Participant Flow|High, Low and Medium Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at highest level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
777293|NCT01483651|P4|Participant Flow|Medium, High and Low Insulin Infusion|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at lowest level with glucagon administration."
777294|NCT01483651|P3|Participant Flow|Medium, Low and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at medium level with glucagon administration.~Second study is regular insulin infused at lowest level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
777295|NCT01483651|P2|Participant Flow|Low, High and Medium Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at highest level with glucagon adminstration.~Third study is regular insulin infused at medium level with glucagon administration."
777296|NCT01483651|P1|Participant Flow|Low, Medium and High Insulin Infusion Rate|"All study subjects in this arm were randomized as follows:~First study is regular insulin infused at lowest level with glucagon administration.~Second study is regular insulin infused at medium level with glucagon adminstration.~Third study is regular insulin infused at highest level with glucagon administration."
777297|NCT01483651|O3|Outcome|High Insulin Infusion Rate|Regular insulin infused at highest level with glucagon administration.
777298|NCT01483651|O2|Outcome|Medium Insulin Infusion Rate|Regular insulin infused at medium level with glucagon administration.
777299|NCT01483651|O1|Outcome|Low Insulin Infusion Rate|Regular insulin infused at lowest level of glucagon administration.
777300|NCT01483651|E3|Reported Event|High Insulin Infusion|regular insulin infused at highest level with glucagon administration.
777301|NCT01483651|E2|Reported Event|Medium Insulin Infusion|Regular insulin infused at medium level with glucagon administration.
777302|NCT01483651|E1|Reported Event|Low Insulin Infusion|Regular insulin infused at lowest level with glucagon administration.
777303|NCT01483625|B3|Baseline|Total|Total of all reporting groups
777304|NCT01483625|B2|Baseline|Tiotropium 18mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777305|NCT01483625|B1|Baseline|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777306|NCT01483625|P2|Participant Flow|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777307|NCT01483625|P1|Participant Flow|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777308|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777309|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777310|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777311|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777312|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777313|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777314|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777315|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777316|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777317|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777318|NCT01483625|O2|Outcome|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777319|NCT01483625|O1|Outcome|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777320|NCT01483625|E2|Reported Event|Tiotropium 18 mcg|active - Tiotropium bromide Inhalation capsule 18 mcg, HandiHaler®
777321|NCT01483625|E1|Reported Event|Placebo|placebo - Placebo Inhalation capsule, HandiHaler®
777322|NCT01483378|B1|Baseline|Survey Participants|
777323|NCT01483378|P2|Participant Flow|Patients Who Declined the Herpes Zoster Vaccine|These eligible subjects completed the survey and then declined to receive the herpes zoster vaccine for free.
777324|NCT01483378|P1|Participant Flow|Patients Who Received the Herpes Zoster Vaccine|These eligible subjects completed the survey and then chose to receive the herpes zoster vaccine for free.
777325|NCT01483378|O2|Outcome|Patients Who Declined the Herpes Zoster Vaccine|Patients who declined to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
777326|NCT01483378|O1|Outcome|Patients Who Received the Herpes Zoster Vaccine|Patients who chose to receive the herpes zoster vaccine completed the survey. Primary outcomes reported are statistically significant answers to the survey questions.
777327|NCT01483378|E2|Reported Event|Subjects Who Declined the Herpes Zoster Vaccine|
777328|NCT01483378|E1|Reported Event|Subjects Who Received the Herpes Zoster Vaccine|
777329|NCT01483352|B1|Baseline|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777556|NCT01482221|P2|Participant Flow|AZD6765 100 mg|Intravenous infusion
777330|NCT01483352|P1|Participant Flow|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777331|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777332|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
778443|NCT01478360|P2|Participant Flow|Placebo|Placebo intravenous injection
777333|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777334|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777335|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777336|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777337|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777338|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777339|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777340|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777341|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777342|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777343|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777344|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777345|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777346|NCT01483352|O1|Outcome|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777347|NCT01483352|E1|Reported Event|Accu-Chek DiaPort|Participants were implanted with Accu-Chek® DiaPort with Infusion set connected to an Accu-Check Insulin Pump to perform continuous intraperitoneal insulin delivery.
777348|NCT01483209|B1|Baseline|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
777349|NCT01483209|P1|Participant Flow|Boxtox Injection|Subjects will serve as their own controls. Both hands are evaluated and the hand demonstrating more severe ischemia will be the one to receive the Botox (experimental treatment).
777350|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
777351|NCT01483209|O1|Outcome|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
777352|NCT01483209|E1|Reported Event|Botox Injection|"Use of botulinum toxin A to determine efficacy in treating vasopressor-induced digital ischemia~Injection of botulinum toxin A: One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy"
777353|NCT01483183|B11|Baseline|Total|Total of all reporting groups
777354|NCT01483183|B10|Baseline|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
777355|NCT01483183|B9|Baseline|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777356|NCT01483183|B8|Baseline|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777357|NCT01483183|B7|Baseline|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777358|NCT01483183|B6|Baseline|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777359|NCT01483183|B5|Baseline|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777360|NCT01483183|B4|Baseline|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
777361|NCT01483183|B3|Baseline|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777362|NCT01483183|B2|Baseline|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777363|NCT01483183|B1|Baseline|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777364|NCT01483183|P10|Participant Flow|Persistent AF - Placebo|Participants received a single dose of placebo, 10-minute constant rate IV infusion.
777365|NCT01483183|P9|Participant Flow|Persistent AF - OPC-108459 1.55 mg/kg|Participants received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777525|NCT01482429|B1|Baseline|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
777366|NCT01483183|P8|Participant Flow|Persistent AF - OPC-108459 1.35 mg/kg|Participants received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777367|NCT01483183|P7|Participant Flow|Persistent AF - OPC-108459 0.60 mg/kg|Participants received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777368|NCT01483183|P6|Participant Flow|Persistent AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777369|NCT01483183|P5|Participant Flow|Persistent AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777370|NCT01483183|P4|Participant Flow|Paroxysmal AF - Placebo|Participants received placebo dose 10-minute constant rate IV infusion.
777371|NCT01483183|P3|Participant Flow|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777372|NCT01483183|P2|Participant Flow|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777373|NCT01483183|P1|Participant Flow|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants received a single dose of OPC-108459 0.26 milligram per kilogram (mg/kg), 10-minute constant rate intravenous (IV) infusion to achieve specified Cmax target.
777374|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
777375|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777376|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777377|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777378|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777379|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777380|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
777381|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777382|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777383|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777384|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
777385|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777386|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777387|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777388|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777389|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777390|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
777391|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777392|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777393|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777394|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
777395|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777396|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777397|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777398|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777399|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777400|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
777401|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777402|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777403|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777404|NCT01483183|O10|Outcome|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
777405|NCT01483183|O9|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777406|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777407|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777408|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777409|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777410|NCT01483183|O4|Outcome|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
777411|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777412|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777413|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777414|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777415|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777416|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777417|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777418|NCT01483183|O4|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777419|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777420|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777421|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777422|NCT01483183|O8|Outcome|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777423|NCT01483183|O7|Outcome|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777424|NCT01483183|O6|Outcome|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777425|NCT01483183|O5|Outcome|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777426|NCT01483183|O4|Outcome|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777427|NCT01483183|O3|Outcome|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777428|NCT01483183|O2|Outcome|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777429|NCT01483183|O1|Outcome|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777430|NCT01483183|E10|Reported Event|Persistent AF - Placebo|Participants had received a single dose of placebo, 10-minute constant rate IV infusion.
777431|NCT01483183|E9|Reported Event|Persistent AF - OPC-108459 1.55 mg/kg|Participants had received a single dose of OPC-108459 1.55 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777432|NCT01483183|E8|Reported Event|Persistent AF - OPC-108459 1.35 mg/kg|Participants had received a single dose of OPC-108459 1.35 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777433|NCT01483183|E7|Reported Event|Persistent AF - OPC-108459 0.60 mg/kg|Participants had received a single dose of OPC-108459 0.60 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777557|NCT01482221|P1|Participant Flow|AZD6765 50 mg|Intravenous infusion
777434|NCT01483183|E6|Reported Event|Persistent AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777435|NCT01483183|E5|Reported Event|Persistent AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777436|NCT01483183|E4|Reported Event|Paroxysmal AF - Placebo|Participants had received placebo dose 10-minute constant rate IV infusion.
777437|NCT01483183|E3|Reported Event|Paroxysmal AF - OPC-108459 1.00 mg/kg|Participants had received a single dose of OPC-108459 1.00 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777438|NCT01483183|E2|Reported Event|Paroxysmal AF - OPC-108459 0.40 mg/kg|Participants had received a single dose of OPC-108459 0.40 mg/kg,10-minute constant rate IV infusion to achieve specified Cmax target.
777439|NCT01483183|E1|Reported Event|Paroxysmal AF - OPC-108459 0.26 mg/kg|Participants had received a single dose of OPC-108459 0.26 mg/kg, 10-minute constant rate IV infusion to achieve specified Cmax target.
777440|NCT01482910|B3|Baseline|Total|Total of all reporting groups
777441|NCT01482910|B2|Baseline|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
777442|NCT01482910|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
777443|NCT01482910|P2|Participant Flow|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
777444|NCT01482910|P1|Participant Flow|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
777445|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
777446|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
777447|NCT01482910|O2|Outcome|PDT Treatments|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48.
777448|NCT01482910|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed.
777449|NCT01482910|E4|Reported Event|PDT Then Aflibercept Injection, From Week 28 to Week 52|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data from week 28 up to week 52 was reported.
777450|NCT01482910|E3|Reported Event|Aflibercept Injection, From Week 28 to Week 52|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data from week 28 up to week 52 was reported.
777451|NCT01482910|E2|Reported Event|PDT Treatments, up to Week 28|Participants received PDT as needed. Additionally, sham IAI injections was administered until week 28. Thereafter, participants received active IAI treatment until week 48. The data up to week 28 was reported.
777452|NCT01482910|E1|Reported Event|Aflibercept Injection, up to Week 28|Participants received 2.0 mg intravitreal aflibercept injection (IAI) every 4 weeks for the first 12 weeks, followed by additional 2.0 mg IAI every 8 weeks until week 48. Additionally, sham photodynamic therapy (PDT) treatments was administered as needed. The data up to week 28 was reported.
777453|NCT01482884|B3|Baseline|Total|Total of all reporting groups
777454|NCT01482884|B2|Baseline|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777455|NCT01482884|B1|Baseline|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777456|NCT01482884|P2|Participant Flow|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777457|NCT01482884|P1|Participant Flow|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777458|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777459|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777460|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777461|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777462|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777463|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777464|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777465|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777558|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
777466|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777467|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777468|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
778444|NCT01478360|P1|Participant Flow|AIN457|AIN457 10 mg/kg
777469|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777470|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777471|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777472|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777473|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777474|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777475|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777476|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777477|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777478|NCT01482884|O2|Outcome|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777479|NCT01482884|O1|Outcome|Tralokinumab|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777480|NCT01482884|E2|Reported Event|Tralokinumab 300 mg|Tralokinumab 300 mg was administered during study as two subcutaneous 150 mg injections every 2 weeks for 12 weeks starting from Visit 2.
777481|NCT01482884|E1|Reported Event|Placebo|Placebo was administered during study as two subcutaneous injections every 2 weeks for 12 weeks starting from Visit 2.
777482|NCT01482819|B1|Baseline|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
777483|NCT01482819|P1|Participant Flow|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
777484|NCT01482819|O5|Outcome|Polymacon|test article
777485|NCT01482819|O4|Outcome|Lotrafilcon A|test article
777486|NCT01482819|O3|Outcome|Galyfilcon A|test article
777487|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
777488|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
777489|NCT01482819|O5|Outcome|Polymacon|test article
777490|NCT01482819|O4|Outcome|Lotrafilcon A|test article
777491|NCT01482819|O3|Outcome|Galyfilcon A|test article
777492|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
777493|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
777494|NCT01482819|O5|Outcome|Polymacon|test article
777495|NCT01482819|O4|Outcome|Lotrafilcon A|test article
777496|NCT01482819|O3|Outcome|Galyfilcon A|test article
777497|NCT01482819|O2|Outcome|Galyfilcon A Plus|Test article
777498|NCT01482819|O1|Outcome|Spectacles|No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.
777499|NCT01482819|E1|Reported Event|All Subjects|Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
777500|NCT01482767|B3|Baseline|Total|Total of all reporting groups
777501|NCT01482767|B2|Baseline|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777502|NCT01482767|B1|Baseline|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777503|NCT01482767|P2|Participant Flow|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777504|NCT01482767|P1|Participant Flow|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777505|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777559|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
777560|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
777506|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777507|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777508|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777509|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777510|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777511|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777512|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777513|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777514|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777515|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777516|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777517|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777518|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777519|NCT01482767|O2|Outcome|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777520|NCT01482767|O1|Outcome|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777521|NCT01482767|E2|Reported Event|HCV Treatment-Experienced (Group B)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV), and non-cirrhotics received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777561|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
777562|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
777563|NCT01482221|O1|Outcome|AZD6765 50 mg|Intravenous infusion
777564|NCT01482221|O3|Outcome|Placebo|Intravenous infusion
777565|NCT01482221|O2|Outcome|AZD6765 100 mg|Intravenous infusion
777522|NCT01482767|E1|Reported Event|HCV Treatment-Naive (Group A)|Participants were prescribed a lead-in with PEG-IFN and RBV for 4 weeks. After the lead-in, BOC was added. Cirrhotic participants received 44 weeks of triple therapy (BOC+PEG-IFN+RBV). Among non-cirrhotics, the week 8 serum HCV RNA was used to determine total duration of therapy. Those who had undetectable HCV RNA at Week 8 completed therapy at Week 28. Those with detectable HCV RNA at Week 8 received 32 weeks of triple therapy followed by 12 additional weeks of PEG-IFN+RBV.
777526|NCT01482429|P2|Participant Flow|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
777527|NCT01482429|P1|Participant Flow|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
777528|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
777529|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
777530|NCT01482429|O2|Outcome|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
777531|NCT01482429|O1|Outcome|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
777532|NCT01482429|E2|Reported Event|Usual Care|Discontinuation of ventilation was left entirely to the discretion of the physicians.
777533|NCT01482429|E1|Reported Event|Protocol-directed|Discontinuation of ventilation was based in multidisciplinary protocol.
777534|NCT01482325|B1|Baseline|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor"
777535|NCT01482325|P1|Participant Flow|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
777536|NCT01482325|O1|Outcome|Subjects Requiring Blood Pressure Monitoring|"St. Joseph’s Hospital (001), there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. Wisconsin Heart Hospital (002), there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study.~There were enrollment criteria followed by both Site 001 and Site 002 that were provided by the study’s GEHC engineer in order to test the SuperSTAT algorithm. Each set of subjects enrolled under the required enrollment criteria were tested by the GEHC engineer."
777537|NCT01482325|E1|Reported Event|Subjects Requiring Blood Pressure Monitoring|"Any subject (neonate-adult) requiring hospital or clinic blood pressure monitoring~Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor: 10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor~At Site #001 – St. Joseph’s Hospital, there were 21 subjects screened, of which five were screen failures and 16 subjects completed the study. There were no adverse events reported.~At Site #002 – Wisconsin Heart Hospital, there were 25 subjects screened, of which 10 were screen failures and 15 subjects completed the study. There were no adverse events reported."
777538|NCT01482312|B1|Baseline|Overall|This reporting group includes all enrolled participants.
777539|NCT01482312|P3|Participant Flow|Glasses / Lotrafilcon A / Comfilcon A|Glasses worn first, followed by lotrafilcon A contact lenses, followed by comfilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
777540|NCT01482312|P2|Participant Flow|Comfilcon A / Glasses / Lotrafilcon A|Comfilcon A contact lenses worn first, followed by glasses, followed by lotrafilcon A contact lenses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
777541|NCT01482312|P1|Participant Flow|Lotrafilcon A / Comfilcon A / Glasses|Lotrafilcon A contact lenses worn first, followed by comfilcon A contact lenses, followed by habitual glasses. Each product worn for 90 minutes in a controlled, low-humidity environment (LHE) chamber. Each period separated by a washout of approximately 7 days.
777542|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
777543|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
777544|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
777545|NCT01482312|O3|Outcome|Glasses|Glasses per habitual prescription
777546|NCT01482312|O2|Outcome|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
777547|NCT01482312|O1|Outcome|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
777548|NCT01482312|E3|Reported Event|Glasses|Glasses per habitual prescription
777549|NCT01482312|E2|Reported Event|Comfilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
777550|NCT01482312|E1|Reported Event|Lotrafilcon A Contact Lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
777551|NCT01482221|B4|Baseline|Total|Total of all reporting groups
777552|NCT01482221|B3|Baseline|Placebo|Intravenous infusion
777553|NCT01482221|B2|Baseline|AZD6765 100 mg|Intravenous infusion
777554|NCT01482221|B1|Baseline|AZD6765 50 mg|Intravenous infusion
777598|NCT01482091|B2|Baseline|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777599|NCT01482091|B1|Baseline|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777600|NCT01482091|P2|Participant Flow|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
778445|NCT01478360|O2|Outcome|Placebo|Placebo intravenous injection
777601|NCT01482091|P1|Participant Flow|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777602|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777603|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777604|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777605|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777606|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777607|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777608|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777609|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777610|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777611|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777612|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777613|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777614|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777615|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777616|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777617|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777618|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777619|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777620|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777621|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777622|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777623|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777624|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777625|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777626|NCT01482091|O2|Outcome|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777627|NCT01482091|O1|Outcome|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777628|NCT01482091|E2|Reported Event|Intranasal Fentnayl|Fentanyl Citrate: A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
777629|NCT01482091|E1|Reported Event|Intranasal Saline|Normal Saline: A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
777630|NCT01482065|B3|Baseline|Total|Total of all reporting groups
777631|NCT01482065|B2|Baseline|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
777632|NCT01482065|B1|Baseline|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
777633|NCT01482065|P2|Participant Flow|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
777634|NCT01482065|P1|Participant Flow|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
777635|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
777636|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
777693|NCT01481558|O1|Outcome|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
777694|NCT01481558|E2|Reported Event|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
777695|NCT01481558|E1|Reported Event|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
777637|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
777638|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
777639|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
777640|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
777641|NCT01482065|O2|Outcome|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
777642|NCT01482065|O1|Outcome|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for Obstructive Sleep Apnea (OSA) severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
777643|NCT01482065|E2|Reported Event|CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the CPAP group will be sent home with an autoset CPAP device, which they will be instructed to utilize for 4 months. The CPAP device will be set in the auto mode so that it will automatically adjust the pressure at night to eliminate upper airway obstruction during sleep.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively."
777644|NCT01482065|E1|Reported Event|Deferred CPAP|"Patients with moderate to severe apnea will be randomized to CPAP or deferred CPAP. Those in the deferred CPAP group will sign a consent to agree to defer CPAP use for 4 months to complete the study.~Criteria for OSA severity are specifically designed to target patients with nocturnal hypoxemia, which is hypothesized to contribute to NAFLD progression. According to the guidelines of the American Academy of Sleep Medicine, apnea will be defined as cessation of airflow for ≥ 10 sec. and hypopnea will be defined as decreased airflow for ≥ 10 sec. leading to oxyhemoglobin desaturation ≥ 4%. Mild, moderate and severe OSA will be diagnosed by an AHI of 5-14.9, 15-29.9, and ≥ 30 events/hr, respectively.~CPAP (ResMed S9 autoset CPAP): A ResMed S9 autoset CPAP device will be utilized throughout the study."
777645|NCT01481935|B3|Baseline|Total|Total of all reporting groups
777696|NCT01481376|B1|Baseline|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777697|NCT01481376|P1|Participant Flow|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777829|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777646|NCT01481935|B2|Baseline|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777701|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777647|NCT01481935|B1|Baseline|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777648|NCT01481935|P2|Participant Flow|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777649|NCT01481935|P1|Participant Flow|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777650|NCT01481935|O2|Outcome|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777651|NCT01481935|O1|Outcome|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777652|NCT01481935|E2|Reported Event|Enhanced Cleaning|Rooms in the Enhanced Cleaning arm received a single extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777653|NCT01481935|E1|Reported Event|Sham Enhanced Cleaning|Rooms in the Sham Enhanced Cleaning arm received a single sham extra cleaning of frequently contaminated surfaces by a study researcher in addition to standard room cleaning by hospital housekeeping staff. Sham Enhanced Cleaning was performed once per day of enrollment and follow-up. Seventeen surfaces identified by the CDC as being 'frequently touched and frequently contaminated' were cleaned as part of the experimental intervention. Cleaning was performed using standard hospital cleaning products (wipes soaked in a commercially-available quaternary ammonium solution).
777654|NCT01481896|B1|Baseline|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
777655|NCT01481896|P1|Participant Flow|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
777656|NCT01481896|O1|Outcome|Patients Satisfied With Outcome of Hip Replacement|"Patient satisfaction was evaluated by asking the question, Are you satisfied with the results of your hip operation? on a questionnaire. Patients could respond Yes or No by filling in the appropriated bubble on the questionnaire."
777657|NCT01481896|O1|Outcome|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
777658|NCT01481896|O2|Outcome|Cup Stability|Based on the most recent follow-up x-ray, the fixation of the cup component implanted in a patient's pelvis was graded as bone ingrown, fibrous stable or loose. A cup was considered fibrous stable if there was a continuous radiolucent line along the interface between the cup and the patient's pelvic bone. A cup was considered loose if it had migrated more than 2 mm or its orientation had changed by at least 5 degrees on the follow-up x-ray compared to the immediate post-operative x-ray. A cup that did not meet the criteria for fibrous stable or loose was considered bone ingrown.
777659|NCT01481896|O1|Outcome|Stem Stability|"Based on the most recent follow-up x-ray, the fixation of the stem component implanted in a patient's femur was graded as bone ingrown, fibrous stable or loose using the criteria defined by Engh, Massin and Suthers in their article titled Roentgenographic assessment of the biologic fixation of porous-surfaced femoral components published in the August 1990 edition of Clinical Orthopaedics and Related Research on pages 107 to 128."
777660|NCT01481896|O2|Outcome|Hips With CT Scans Analyzed for Pelvic Osteolysis|Digital Computed Tomography (CT) scans taken more than 5 years after a patient's hip replacement were used to evaluate pelvic bone loss (osteolysis). Regions of bone loss were traced on CT slices to determine the volume and location of each osteolytic defect using three-dimensional image analysis software (Analyze, Biomedical Imaging Resource, Rochester, MN). For the purposes of reporting, the total number of hips with any evidence of pelvic osteolysis on CT is indicated.
777661|NCT01481896|O1|Outcome|Hips With Radiographs Analyzed for Femoral Osteolysis|Serial x-rays for each hip replacement were analyzed by a single experienced reviewer to identify regions where bone had been lost in the femur. Expansile (ballooned-out) regions of bone loss identified on follow-up x-rays taken at least 4.75 years after their surgery that were not apparent on the immediate post-operative x-ray were considered to be osteolysis. For the purposes of reporting, the total number of hips with any evidence of femoral osteolysis on x-ray is indicated.
777662|NCT01481896|O1|Outcome|Hips With Harris Hip Scores|The Harris Hip Score is an outcome measure used for hip replacements that ranges from 0 (worst) to 100 (best). The score consists of a series of questions related to hip pain, function and range of motion that accumulate a different number of points depending on the response choices. At the time of their follow-up visits, patients completed a standardized questionnaire that included components of the Harris Hip Score and the physician completed a standardized evaluation which included range of motion assessment.
777663|NCT01481896|O2|Outcome|Cup Anteversion Angle|The Cup Anteversion Angle quantifies the front-to-back rotation of the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the circular face of the cup projects onto the x-ray as an ellipse. The ratio of the major axis of the ellipse to the minor axis can be used to calculate the anteversion. A cup rotated anteriorly has positive anteversion. A cup rotated posteriorly has negative anteversion. For this study, the cup Anteversion Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL). Taken together, the abduction and anteversion angle quantify the three-dimensional orientation of the cup.
777664|NCT01481896|O1|Outcome|Cup Abduction Angle|The Cup Abduction Angle quantifies the amount of tilt associated with the hemispheric implant implanted inside a patient's pelvis to replace their hip socket. When an anterioposterior (front-to-back) x-ray is taken, the angle between the face of the cup and a horizontal line defines the Cup Abduction Angle. The line defining the face of the cup is drawn through the uppermost and lowest edges of the cup's projection on the x-ray. For this study, the Cup Abduction Angle was measured from digitized x-rays using Dr. John Martell's Hip Suite Analysis Software (University of Chicago, Chicago, IL).
777665|NCT01481896|O2|Outcome|Patients With Serum Chromium Levels|Patients were recommended to have blood drawn for evaluation of serum chromium levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. The chromium detection limit was 0.1 micrograms per liter for all labs that performed metal level assessments. Patients with undetectable chromium levels were assigned a value of zero. A patient's chromium level was considered high if it was 7 micrograms per liter or greater.
777666|NCT01481896|O1|Outcome|Patients With Serum Cobalt Levels|Patients were recommended to have blood drawn for evaluation of serum cobalt levels if they were considered to be active or thought to be at risk for an adverse local tissue reaction. Blood was drawn at our hospital or a facility of the patient's choice. Among all the labs that performed metal level assessments, the cobalt detection limit varied from 0.5 to 1.0 microgram per liter. Patients with undetectable cobalt levels were assigned a value of zero. A patient's cobalt level was considered high if it was 7 micrograms per liter or greater.
777667|NCT01481896|E1|Reported Event|Metal-on-Metal Total Hip Arthroplasties|Consecutive series of primary total hip arthroplasties performed with DePuy Pinnacle cups, Ultamet metal liners and 36-mm cobalt-chromium alloy femoral heads.
777668|NCT01481740|B3|Baseline|Total|Total of all reporting groups
777669|NCT01481740|B2|Baseline|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777670|NCT01481740|B1|Baseline|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777671|NCT01481740|P2|Participant Flow|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777672|NCT01481740|P1|Participant Flow|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777673|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777674|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777675|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777676|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777677|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777678|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777679|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777680|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777681|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777682|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777683|NCT01481740|O2|Outcome|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777684|NCT01481740|O1|Outcome|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777685|NCT01481740|E2|Reported Event|Phenylephrine Infusion|phenylephrine infusion: 60ml infusion of 100mcg/ml phenylephrine and placebo bolus
777686|NCT01481740|E1|Reported Event|Phenylephrine Bolus|Phenylephrine bolus: 10 ml of 100mcg/ml phenylephrine and placebo infusion
777687|NCT01481558|B3|Baseline|Total|Total of all reporting groups
777688|NCT01481558|B2|Baseline|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
777689|NCT01481558|B1|Baseline|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
777690|NCT01481558|P2|Participant Flow|Transcranial Direct Current Stimulation|One application of tDCS every two days (total: 6 applications)
777691|NCT01481558|P1|Participant Flow|Sham Transcranial Direct Current Stimulation|One application of sham tDCS every two days (total: 6 applications)
777698|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777699|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777700|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777702|NCT01481376|O1|Outcome|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777703|NCT01481376|E1|Reported Event|Parietex Progrip|Surgical cure of inguinal hernia using the Parietex™ ProGrip™ mesh by Laparoscopic Transabdominal Preperitoneal (TAPP) approach
777704|NCT01481324|B4|Baseline|Total|Total of all reporting groups
777705|NCT01481324|B3|Baseline|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
777706|NCT01481324|B2|Baseline|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777707|NCT01481324|B1|Baseline|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777708|NCT01481324|P3|Participant Flow|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
777709|NCT01481324|P2|Participant Flow|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777710|NCT01481324|P1|Participant Flow|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777711|NCT01481324|O3|Outcome|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
777712|NCT01481324|O2|Outcome|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777713|NCT01481324|O1|Outcome|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777714|NCT01481324|E3|Reported Event|No Sensor Group|This group will not have a pressure sensor placed on the foot ankle orthosis.
777715|NCT01481324|E2|Reported Event|Non-Functioning Pressure Sensor Group|This group will have a non-functioning pressure sensor (a placebo) placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777716|NCT01481324|E1|Reported Event|Functioning Pressure Sensor Group|This group will have a functioning pressure sensor placed on the foot ankle orthosis. The group will be blinded as to whether or not the sensor is functioning.
777717|NCT01481129|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777718|NCT01481129|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777719|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777720|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777721|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777722|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777723|NCT01481129|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777724|NCT01481129|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO once weekly on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
777725|NCT01481116|B4|Baseline|Total|Total of all reporting groups
777726|NCT01481116|B3|Baseline|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777727|NCT01481116|B2|Baseline|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777825|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777728|NCT01481116|B1|Baseline|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777729|NCT01481116|P3|Participant Flow|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777730|NCT01481116|P2|Participant Flow|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777731|NCT01481116|P1|Participant Flow|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777732|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777733|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777734|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777735|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777736|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777737|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777738|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777739|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777740|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777741|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777742|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777743|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777744|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777745|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777746|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777747|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777748|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777749|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
799153|NCT01401153|E2|Reported Event|Skipping Lunch|No lunch (water)
777750|NCT01481116|O3|Outcome|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777751|NCT01481116|O2|Outcome|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777832|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777752|NCT01481116|O1|Outcome|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777753|NCT01481116|E3|Reported Event|TAK-875 50 mg|TAK-875 50 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777754|NCT01481116|E2|Reported Event|TAK-875 25 mg|TAK-875 25 mg, tablets, orally, once daily and glimepiride placebo-matching capsules, orally, once daily along with metformin >=1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks.
777755|NCT01481116|E1|Reported Event|Glimepiride|TAK-875 placebo-matching tablets, orally, once daily and glimepiride 1 mg, over-encapsulated capsules, orally, once daily for 1 week followed by up-titration in 2 mg increments up to 6 mg, orally, once daily along with metformin greater than or equal to (>=)1500 mg per day or maximum tolerated dose, tablets, orally for up to 104 weeks. Glimepiride dose could be down-titrated from 6 mg in case of recurrent or severe hypoglycemia.
777756|NCT01480674|B1|Baseline|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777757|NCT01480674|P1|Participant Flow|Trastuzumab|Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab (Herceptin) as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777758|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777759|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777760|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777761|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777762|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777763|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777764|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777765|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777766|NCT01480674|O1|Outcome|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777767|NCT01480674|E1|Reported Event|Trastuzumab|Eligible participants with HER2-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
777768|NCT01480596|B3|Baseline|Total|Total of all reporting groups
777769|NCT01480596|B2|Baseline|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777770|NCT01480596|B1|Baseline|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777771|NCT01480596|P2|Participant Flow|Belimumab 10 mg/kg IV|Participants received 10 milligrams per kilogram (mg/kg) of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777772|NCT01480596|P1|Participant Flow|Placebo IV|Participants received 250 milliliter (ml) of a normal saline placebo administered as intravenous (IV) infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777826|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
779532|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
777773|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777833|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777774|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777775|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777776|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777777|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777778|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777779|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777780|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777781|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777782|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777783|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777784|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777785|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777786|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777787|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777788|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777789|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777790|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777791|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777792|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777793|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777794|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777795|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777827|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777796|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
778446|NCT01478360|O1|Outcome|AIN457|AIN457 10 mg/kg
777797|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777798|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777799|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777800|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777801|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777802|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777803|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777804|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777805|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777806|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777807|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777808|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777809|NCT01480596|O2|Outcome|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777810|NCT01480596|O1|Outcome|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777811|NCT01480596|E2|Reported Event|Belimumab 10 mg/kg IV|Participants received 10 mg/kg of belimumab administered as IV infusion in 250 mL normal saline on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777812|NCT01480596|E1|Reported Event|Placebo IV|Participants received 250 ml of a normal saline placebo administered as IV infusion on Days 0, 14, 28 and then every 28 days through Week 20 of the treatment period. Participants continued with the standard of care therapy throughout the treatment period.
777813|NCT01480297|B1|Baseline|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
777814|NCT01480297|P1|Participant Flow|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
777815|NCT01480297|O1|Outcome|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
777816|NCT01480297|E1|Reported Event|Salsalate|"All subjects will take Salsalate, 3 grams daily (as 3 divided doses of 1 gram with breakfast, lunch and dinner).~Salsalate: Salsalate 3 grams daily (1 gram TID with meals)"
777817|NCT01480284|B3|Baseline|Total|Total of all reporting groups
777818|NCT01480284|B2|Baseline|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777819|NCT01480284|B1|Baseline|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777820|NCT01480284|P2|Participant Flow|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777821|NCT01480284|P1|Participant Flow|TDF 300 mg OD|Participants received Tenofovir Disoproxil Fumarate (TDF) 300 milligrams (mg) tablet once daily (OD) and Entecavir Hydrate (ETV) placebo capsule OD for 96 weeks.
777822|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777823|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777824|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777830|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777831|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777834|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777835|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777836|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777837|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777838|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777839|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777840|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777841|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777842|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777843|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777844|NCT01480284|O2|Outcome|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777845|NCT01480284|O1|Outcome|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777846|NCT01480284|E2|Reported Event|ETV 0.5 mg OD|Participants received ETV 0.5 mg capsule OD and TDF placebo tablet OD for 48 weeks.
777847|NCT01480284|E1|Reported Event|TDF 300 mg OD|Participants received TDF 300 mg tablet OD and ETV placebo capsule OD for 96 weeks.
777848|NCT01480232|B5|Baseline|Total|Total of all reporting groups
777849|NCT01480232|B4|Baseline|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777850|NCT01480232|B3|Baseline|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777851|NCT01480232|B2|Baseline|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777852|NCT01480232|B1|Baseline|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777853|NCT01480232|P4|Participant Flow|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777854|NCT01480232|P3|Participant Flow|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777855|NCT01480232|P2|Participant Flow|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT (nicotine replacement therapy) Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777856|NCT01480232|P1|Participant Flow|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
799154|NCT01401153|E1|Reported Event|Having Lunch|Lunch ad libitum
777857|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777858|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777859|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777860|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777861|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777862|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777863|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777864|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777865|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777866|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777867|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777868|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777883|NCT01480219|B1|Baseline|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
777884|NCT01480219|P2|Participant Flow|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
777869|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777870|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777871|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777872|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777873|NCT01480232|O4|Outcome|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777874|NCT01480232|O3|Outcome|Placebo + NicoDerm CQ (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777875|NCT01480232|O2|Outcome|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777876|NCT01480232|O1|Outcome|EVP-6124 + NicoDerm CQ (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm CQ patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm CQ Patch (Active): One NicoDerm CQ patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777877|NCT01480232|E4|Reported Event|Placebo + NRT Patch (Placebo)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777878|NCT01480232|E3|Reported Event|Placebo + NicoDerm (Active)|"One placebo capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~Placebo Capsule: One placebo capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777879|NCT01480232|E2|Reported Event|EVP-6124 + NRT Patch (Placebo)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NRT patch (Placebo) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NRT Patch (Placebo): One NRT patch (Placebo) daily for first 6 weeks (42 days).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777880|NCT01480232|E1|Reported Event|EVP-6124 + NicoDerm (Active)|"One EVP-6124 capsule ingested orally daily for 12 weeks (84 days) and one NicoDerm patch (Active) daily for first 6 weeks (42 days)~EVP-6124: One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)~NicoDerm Patch (Active): One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).~Brief Supportive and Behavioral Treatment: Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association."
777881|NCT01480219|B3|Baseline|Total|Total of all reporting groups
777882|NCT01480219|B2|Baseline|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
779541|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
777885|NCT01480219|P1|Participant Flow|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
777886|NCT01480219|O2|Outcome|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
778186|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
777887|NCT01480219|O1|Outcome|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
777888|NCT01480219|E2|Reported Event|Voriconazole|Participants having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
777889|NCT01480219|E1|Reported Event|No Voriconazole|Participants not having any voriconazole prescription claims in the period 180 days before or after the date of lung or heart/lung transplant.
777890|NCT01480089|B3|Baseline|Total|Total of all reporting groups
777891|NCT01480089|B2|Baseline|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
777892|NCT01480089|B1|Baseline|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
777893|NCT01480089|P2|Participant Flow|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
777894|NCT01480089|P1|Participant Flow|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
777895|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
777896|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
777897|NCT01480089|O2|Outcome|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
777898|NCT01480089|O1|Outcome|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
777899|NCT01480089|E2|Reported Event|Atomized Intraperitoneal Saline (AIS)|Participants randomized to this arm are given atomized intraperitoneal saline(AIS) to the peritoneal cavity at the completion of surgery.
777900|NCT01480089|E1|Reported Event|Intraperitoneal Ropivacaine(AIR)|Participants randomized to this arm receive atomized intraperitoneal ropivacaine (AIR). That is, 2 mg/kg of lean body mass up to no more than 200mg total dose is atomized and delivered into the peritoneal cavity at the completion of surgery.
777901|NCT01480076|B3|Baseline|Total|Total of all reporting groups
777902|NCT01480076|B2|Baseline|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
777903|NCT01480076|B1|Baseline|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks.
777904|NCT01480076|P1|Participant Flow|Fampridine|All participants took 10 mg fampridine twice daily for the first 4 weeks. If deemed a treatment responder, the participant continued 10 mg fampridine twice daily for 44 weeks. Treatment non-responders continued without treatment by completing quality of life questionnaires.
777905|NCT01480076|O3|Outcome|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777906|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777907|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777908|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777909|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777910|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777911|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777912|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777913|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777914|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777915|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778187|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
777916|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777917|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777918|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777919|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777920|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777921|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777922|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777923|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777924|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777925|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777926|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777927|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777928|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777929|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777930|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777931|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777932|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777933|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777934|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777935|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777936|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777937|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777938|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777939|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777940|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
779995|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan 3mg once daily.
777941|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777942|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777943|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777944|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777945|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777946|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777947|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777948|NCT01480076|O4|Outcome|Non-responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777949|NCT01480076|O3|Outcome|Responder: Not Taking Additional MS Therapy|Participants (not taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777950|NCT01480076|O2|Outcome|Non-responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777951|NCT01480076|O1|Outcome|Responder: Taking Additional MS Therapy|Participants (taking additional MS therapy) took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777952|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777953|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777954|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777955|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777956|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777957|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777958|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777959|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777960|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777961|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777962|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777963|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777964|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777965|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777966|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777967|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777968|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777969|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777970|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777971|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777972|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777973|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777974|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777975|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777976|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777977|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777978|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777979|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777980|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777981|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777982|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777983|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777984|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777985|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777986|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777987|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777988|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777989|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777990|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777991|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
778182|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
799155|NCT01401101|B3|Baseline|Total|Total of all reporting groups
777992|NCT01480076|O4|Outcome|Progressive-Relapsing MS|"Participants in the Responder group with progressive-relapsing MS (PRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777993|NCT01480076|O3|Outcome|Primary-Progressive MS|"Participants in the Responder group with primary-progressive MS (PPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777994|NCT01480076|O2|Outcome|Secondary-Progressive MS|"Participants in the Responder group with secondary-progressive MS (SPMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777995|NCT01480076|O1|Outcome|Relapsing-Remitting MS|"Participants in the Responder group with relapsing-remitting MS (RRMS).~Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks."
777996|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777997|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
777998|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
777999|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778000|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778001|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778002|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778003|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778004|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778005|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778006|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778007|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778008|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778009|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778010|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778011|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778012|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778013|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778014|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778015|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778016|NCT01480076|O2|Outcome|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778017|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778018|NCT01480076|O1|Outcome|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778019|NCT01480076|E3|Reported Event|All Participants|All participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778020|NCT01480076|E2|Reported Event|Non-responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment non-responders continued without treatment by completing quality of life questionnaires.
778021|NCT01480076|E1|Reported Event|Responder|Participants took 10 mg fampridine twice daily for the first 4 weeks. Those deemed treatment responders continued 10 mg fampridine twice daily for 44 weeks.
778183|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778184|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
779996|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
778188|NCT01479595|E2|Reported Event|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
778189|NCT01479595|E1|Reported Event|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778022|NCT01479868|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778023|NCT01479868|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778024|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778025|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778026|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778027|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778028|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778029|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778030|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778031|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778032|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778033|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
779997|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
778034|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778035|NCT01479868|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778036|NCT01479868|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants received TMC435, 150 mg once daily plus peginterferon alfa-2a (PegIFN alfa-2a) and ribavirin (RBV) for 12 Weeks, followed by PegIFN alfa-2a (P) and RBV (R) until Week 24/48 (PR24/48). Treatment was to be stopped at Week 24 for HCV treatment-naïve and prior HCV relapsers who met the response guided therapy criteria, and who did not have cirrhosis. All prior HCV non-responders (null and partial), participants with cirrhosis, and HCV treatment-naïve and prior HCV relapsers who did not meet the response guided therapy criteria had a 48-week treatment period.
778037|NCT01479777|B1|Baseline|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778038|NCT01479777|P1|Participant Flow|FES Stepping|For the next 8 weeks, we will ask you to come to the ICSCI twice (2) time per week during which you will perform FES Stepping.
778039|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778040|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778041|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778042|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778043|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778044|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778045|NCT01479777|O1|Outcome|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778046|NCT01479777|E1|Reported Event|FES Stepping|FES Stepping, twice a week, for 8 weeks.
778047|NCT01479764|B3|Baseline|Total|Total of all reporting groups
778048|NCT01479764|B2|Baseline|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
778049|NCT01479764|B1|Baseline|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
778050|NCT01479764|P2|Participant Flow|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
778051|NCT01479764|P1|Participant Flow|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
778052|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
778053|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
778054|NCT01479764|O2|Outcome|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
778055|NCT01479764|O1|Outcome|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
778056|NCT01479764|E2|Reported Event|Neostigmine/Glycopyrrolate|Participants receive a single IV bolus dose of neostigmine/glycopyrrolate (neostigmine total dose not to exceed 5 mg) per usual practice
778057|NCT01479764|E1|Reported Event|Sugammadex|Participants receive a single intravenous (IV) bolus dose of sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery
778058|NCT01479725|B3|Baseline|Total|Total of all reporting groups
778059|NCT01479725|B2|Baseline|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
778060|NCT01479725|B1|Baseline|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
778061|NCT01479725|P2|Participant Flow|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
778062|NCT01479725|P1|Participant Flow|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
778063|NCT01479725|O2|Outcome|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
778064|NCT01479725|O1|Outcome|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
778065|NCT01479725|E2|Reported Event|Non-Ulcerative IC|"HBOT for non-ulcerative IC~HBOT: HBOT"
778066|NCT01479725|E1|Reported Event|Ulcerative IC|"HBOT for ulcerative IC~HBOT: HBOT"
778067|NCT01479621|B7|Baseline|Total|Total of all reporting groups
778068|NCT01479621|B6|Baseline|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778069|NCT01479621|B5|Baseline|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778070|NCT01479621|B4|Baseline|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778071|NCT01479621|B3|Baseline|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778072|NCT01479621|B2|Baseline|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778073|NCT01479621|B1|Baseline|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778074|NCT01479621|P7|Participant Flow|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778075|NCT01479621|P6|Participant Flow|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778076|NCT01479621|P5|Participant Flow|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778077|NCT01479621|P4|Participant Flow|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778078|NCT01479621|P3|Participant Flow|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778079|NCT01479621|P2|Participant Flow|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778080|NCT01479621|P1|Participant Flow|Placebo MDPI (Run-In)|Upon enrollment, participants used current asthma medications and 1 inhalation of placebo multidose dry powder inhaler (MDPI), single-blind, twice daily for 14-day (±2 days).
778081|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778082|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778083|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778084|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778085|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778086|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778185|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778087|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778088|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778089|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778090|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778091|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778092|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778093|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778094|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778095|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778096|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778097|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778098|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778099|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778100|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778101|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778102|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
800369|NCT01396226|B3|Baseline|Total|Total of all reporting groups
778103|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778104|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778105|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778106|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778107|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778108|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778109|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778110|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778111|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778112|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778113|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778114|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778115|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778116|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778117|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778118|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
800370|NCT01396226|B2|Baseline|PLACEBO|Placebo solution for infusion
778119|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778120|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778121|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778122|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778123|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778124|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778125|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778126|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778127|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778128|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778129|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778130|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778131|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778132|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778133|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778134|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778135|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778136|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778137|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778138|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778139|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778140|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778141|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778142|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778143|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778144|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778145|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778146|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778147|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778148|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778149|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778150|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
800371|NCT01396226|B1|Baseline|AZD2927|AZD2927 solution for infusion
778151|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778152|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778153|NCT01479621|O6|Outcome|Flovent Diskus 100mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778154|NCT01479621|O5|Outcome|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner. During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms.
778155|NCT01479621|O4|Outcome|Fp MDPI 100 mcg|"Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778156|NCT01479621|O3|Outcome|Fp MDPI 50 mcg|"Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778157|NCT01479621|O2|Outcome|Fp MDPI 25 mcg|"Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778158|NCT01479621|O1|Outcome|Fp MDPI 12.5 mcg|"Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.~During the run-in and the treatment periods, all subjects replaced their current rescue medication with albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI) (90 mcg/actuation) for use on an as needed basis for the relief of asthma symptoms."
778159|NCT01479621|E6|Reported Event|Placebo MDPI|Placebo twice a day using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
778160|NCT01479621|E5|Reported Event|Fp MDPI 50 mcg|Fluticasone propionate (Fp) 50 mcg per dose twice a day (for a total daily dose of 100 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
778161|NCT01479621|E4|Reported Event|Fp MDPI 25 mcg|Fluticasone propionate (Fp) 25 mcg per dose twice a day (for a total daily dose of 50 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
778162|NCT01479621|E3|Reported Event|Fp MDPI 12.5 mcg|Fluticasone propionate (Fp) 12.5 mcg per dose twice a day (for a total daily dose of 25 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
778163|NCT01479621|E2|Reported Event|Fp MDPI 100 mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in a double-blind manner.
778164|NCT01479621|E1|Reported Event|Flovent Diskus 100mcg|Fluticasone propionate (Fp) 100 mcg per dose twice a day (for a total daily dose of 200 mcg) using a multidose dry powder inhaler (MDPI) for 12 weeks in an open-label manner.
778165|NCT01479595|B3|Baseline|Total|Total of all reporting groups
778166|NCT01479595|B2|Baseline|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
778167|NCT01479595|B1|Baseline|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778168|NCT01479595|P2|Participant Flow|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
778169|NCT01479595|P1|Participant Flow|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778170|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
778171|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778172|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778173|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778174|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778175|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778176|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
778177|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778178|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
778179|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778180|NCT01479595|O2|Outcome|Placebo|Participants received placebo to QBX258 iv infusion every 4 weeks for up to 4 doses total.
778181|NCT01479595|O1|Outcome|QBX258|Participants received QBX258 intravenous (iv) infusion every 4 weeks for up to 4 doses total.
778191|NCT01479543|B5|Baseline|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
778192|NCT01479543|B4|Baseline|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778193|NCT01479543|B3|Baseline|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778194|NCT01479543|B2|Baseline|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
778195|NCT01479543|B1|Baseline|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
778196|NCT01479543|P5|Participant Flow|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
778197|NCT01479543|P4|Participant Flow|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778198|NCT01479543|P3|Participant Flow|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778199|NCT01479543|P2|Participant Flow|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
778200|NCT01479543|P1|Participant Flow|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
778201|NCT01479543|O5|Outcome|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
778202|NCT01479543|O4|Outcome|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778203|NCT01479543|O3|Outcome|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778204|NCT01479543|O2|Outcome|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
778205|NCT01479543|O1|Outcome|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
778206|NCT01479543|E5|Reported Event|Group E|"Volunteers receive a placebo.~Placebo capsule: Placebo capsule for 28 days."
778207|NCT01479543|E4|Reported Event|Group D|"Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.~Probiotics CNCM I-4035 and CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778208|NCT01479543|E3|Reported Event|Group C|"Volunteers are given Probiotic CNCM I-4036.~Probiotic CNCM I-4036: 9x10E9 cfu (colony forming unit) per day during 28 days."
778209|NCT01479543|E2|Reported Event|Group B|"Volunteers receive Probiotic CNCM I-4035.~Probiotic CNCM I-4035: 9x10E9 cfu (colony forming unit) per day during 28 days."
778210|NCT01479543|E1|Reported Event|Group A|"Volunteers are given strain CNCM I-4034.~Probiotic CNCM I-4034: 9x10E9 cfu (colony forming unit) per day during 28 days."
778211|NCT01479530|B3|Baseline|Total|Total of all reporting groups
778212|NCT01479530|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 16 weeks
778213|NCT01479530|B1|Baseline|Placebo|Once daily; tablet; orally; 16 weeks
778214|NCT01479530|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 16 weeks
778215|NCT01479530|P1|Participant Flow|Placebo|Once daily; tablet; orally; 16 weeks
778216|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
778217|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
778218|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
778219|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
778220|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
778221|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
778222|NCT01479530|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 16 weeks
778223|NCT01479530|O1|Outcome|Placebo|Once daily; tablet; orally; 16 weeks
778224|NCT01479530|E2|Reported Event|Azilect®|1 mg daily; tablet; orally; 16 weeks
778225|NCT01479530|E1|Reported Event|Placebo|Once daily; tablet; orally; 16 weeks
778226|NCT01479517|B4|Baseline|Total|Total of all reporting groups
778227|NCT01479517|B3|Baseline|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
778228|NCT01479517|B2|Baseline|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
778229|NCT01479517|B1|Baseline|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
778230|NCT01479517|P3|Participant Flow|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
778231|NCT01479517|P2|Participant Flow|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
778232|NCT01479517|P1|Participant Flow|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
778233|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
778331|NCT01478971|E1|Reported Event|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
778234|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
778235|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
778236|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
778237|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
778238|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
778239|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
778240|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
778241|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
778242|NCT01479517|O3|Outcome|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
778243|NCT01479517|O2|Outcome|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
778244|NCT01479517|O1|Outcome|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
778245|NCT01479517|E3|Reported Event|Kovacaine Mist, 0.2 mL x 1 Spray|"Total dose: 6 mg tetracaine/0.1 mg oxymetazoline~Kovacaine Mist 0.2 mL x 1 spray: Dose = 1 intranasal spray of study drug"
778246|NCT01479517|E2|Reported Event|Kovacaine Mist 0.2 mL x 2 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.2 mL x 2 sprays: Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals."
778247|NCT01479517|E1|Reported Event|Kovacaine Mist 0.1 mL x 4 Sprays|"Total dose: 12 mg tetracaine/0.2 mg oxymetazoline~Kovacaine Mist 0.1 mL x 4 sprays: Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals."
778248|NCT01479374|B4|Baseline|Total|Total of all reporting groups
778249|NCT01479374|B3|Baseline|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778250|NCT01479374|B2|Baseline|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778251|NCT01479374|B1|Baseline|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778252|NCT01479374|P3|Participant Flow|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778253|NCT01479374|P2|Participant Flow|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778254|NCT01479374|P1|Participant Flow|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778255|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778256|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778257|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778258|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778259|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778260|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778261|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778262|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778263|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778264|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778265|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778266|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778267|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778268|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778269|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778270|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778271|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778272|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778273|NCT01479374|O3|Outcome|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778274|NCT01479374|O2|Outcome|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778275|NCT01479374|O1|Outcome|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778276|NCT01479374|E3|Reported Event|Pataday|Olopatadine hydrochloride ophthalmic solution, 0.2%, 1 drop to each eye, 3 nonconsecutive days
778277|NCT01479374|E2|Reported Event|Vehicle|AL-4943A vehicle, 1 drop to each eye, 3 nonconsecutive days
778278|NCT01479374|E1|Reported Event|AL-4943A|AL-4943A ophthalmic solution, 1 drop to each eye, 3 nonconsecutive days
778329|NCT01478971|E3|Reported Event|Peginesatide Treatment Period|In the second six months of the study participants transitioned to once monthly peginesatide injection (the Peginesatide Treatment Period [PTP]).
778332|NCT01478958|B4|Baseline|Total|Total of all reporting groups
778333|NCT01478958|B3|Baseline|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
778334|NCT01478958|B2|Baseline|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
778335|NCT01478958|B1|Baseline|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
778336|NCT01478958|P3|Participant Flow|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
778279|NCT01479127|B1|Baseline|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778280|NCT01479127|P1|Participant Flow|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-Parkinson's disease (PD) medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel [LCIG]), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by a naso-jejunum (NJ) tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778281|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778282|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
778283|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
778284|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
778285|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
778286|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
778287|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
778288|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
778289|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
778290|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant's symptoms."
778291|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
778292|NCT01479127|O2|Outcome|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778293|NCT01479127|O1|Outcome|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
778294|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778330|NCT01478971|E2|Reported Event|ESA Free Week|A one-week erythropoiesis-stimulating agent (ESA)-free period following 6 months of standard of care.
779998|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
778295|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778296|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778297|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778298|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778299|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778300|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778301|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778302|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778303|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778304|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778305|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
800861|NCT01394614|B3|Baseline|Total|Total of all reporting groups
778306|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778307|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778308|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778309|NCT01479127|O1|Outcome|Levodopa-carbidopa Intestinal Gel|"Following a 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours), participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778310|NCT01479127|O1|Outcome|Oral Levodopa/Carbidopa Tablet|During a 28-day Run-in Period, participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours)
778311|NCT01479127|E2|Reported Event|Levodopa-carbidopa Intestinal Gel|"Participants receive ABT-SLV187 (levodopa-carbidopa intestinal gel), administered over 16 hours a day with an infusion pump directly into the proximal jejunum by an NJ tube, for 3 weeks.~The individually-adjusted infusion dose (composed of the morning dose, the continuous maintenance dose, and the extra dose) is optimized by the Investigator for each participant during the study based on the participant’s symptoms."
778312|NCT01479127|E1|Reported Event|Oral Levodopa-carbidopa Tablets|A 28-day Run-in Period where participants are switched from prior anti-PD medications to monotherapy with an oral 100 mg levodopa/10 mg carbidopa tablet (optimized every 3rd hour during waking hours).
778313|NCT01479010|B1|Baseline|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
778314|NCT01479010|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
778315|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
778316|NCT01479010|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
778317|NCT01479010|E1|Reported Event|Anakinra|Anakinra 100 mg subcutaneously daily: Anakinra 100 mg subcutaneously daily
778318|NCT01478971|B1|Baseline|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
778319|NCT01478971|P1|Participant Flow|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
778320|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
778321|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
778322|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
778323|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
778324|NCT01478971|O2|Outcome|Peginesatide Treatment Period|In the second six months of the study participants transitioned to peginesatide injection (the Peginesatide Treatment Period [PTP]).
778325|NCT01478971|O1|Outcome|Epoetin Standard of Care|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]).
778326|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
778327|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
778328|NCT01478971|O1|Outcome|Peginesatide Injection|In the first 6 months participants received Standard of Care treatment with epoetin (the Standard of Care Period [SCP]), followed by a 1 -week erythropoiesis-stimulating agent (ESA)-free period, followed by a transition to once monthly peginesatide injection for 6 months (the Peginesatide Treatment Period [PTP]).
778337|NCT01478958|P2|Participant Flow|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
778338|NCT01478958|P1|Participant Flow|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
778339|NCT01478958|O3|Outcome|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
778340|NCT01478958|O2|Outcome|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
778341|NCT01478958|O1|Outcome|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
778342|NCT01478958|E3|Reported Event|High n-6 Polyunsaturated Fat Diet|n-6 PUFA diet: Volunteers followed a high n-6 polyunsaturated fat diet for a 4-month period
778343|NCT01478958|E2|Reported Event|High Monounsaturated Fat Diet|MUFA diet: Volunteers followed a high monounsaturated fat diet for a 4-month period
778344|NCT01478958|E1|Reported Event|High Saturated Fat Diet|SFA diet: Volunteers followed a high saturated fat diet for a 4-month period
778345|NCT01478828|B1|Baseline|Lovastatin|"After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.~Lovastatin: oral qd varying dose escalations/de-escalations"
778346|NCT01478828|P1|Participant Flow|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
778347|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
778348|NCT01478828|O1|Outcome|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
778349|NCT01478828|E1|Reported Event|Lovastatin|After informed consent and central pathology review of the core prostate biopsy, eligible patients who decide to undergo prostatectomy at Johns Hopkins will be scheduled to receive po lovastatin following a four times a day schedule, at the starting dose of 20 mg/kg/day. Following an initial period of monitoring for safety at this entry dose level of one month, we will then accrue patients to dose de-escalation (to 1, and 10 mg/kg/day) cohorts.
778350|NCT01478620|B1|Baseline|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
778351|NCT01478620|P1|Participant Flow|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
778352|NCT01478620|O1|Outcome|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
778353|NCT01478620|E1|Reported Event|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
778354|NCT01478594|B3|Baseline|Total|Total of all reporting groups
778355|NCT01478594|B2|Baseline|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778356|NCT01478594|B1|Baseline|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778357|NCT01478594|P2|Participant Flow|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778358|NCT01478594|P1|Participant Flow|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each 28-day cycle for 21 days followed by 7 days off treatment. Participants also received modified FOLFOX6 (mFOLFOX6) chemotherapy consisting of oxaliplatin, 85 mg/m^2, leucovorin 400 mg/m^2, and 5-fluorouracil 400 mg/m^2 bolus then 2400 mg/m^2 every 2 weeks on Days 1 and 15 of each cycle.
778359|NCT01478594|O4|Outcome|Bevacizumab: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778360|NCT01478594|O3|Outcome|Bevacizumab: PIGF RNA < Median|Participants with PIGF RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778361|NCT01478594|O2|Outcome|Tivozanib: PIGF RNA ≥ Median|Participants with PIGF RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778362|NCT01478594|O1|Outcome|Tivozanib: PIGF RNA < Median|Participants with PIGF RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778363|NCT01478594|O4|Outcome|Bevacizumab: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778364|NCT01478594|O3|Outcome|Bevacizumab: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778440|NCT01478360|B3|Baseline|Total|Total of all reporting groups
778441|NCT01478360|B2|Baseline|Placebo|Placebo intravenous injection
778365|NCT01478594|O2|Outcome|Tivozanib: VEGF-D RNA ≥ Median|Participants with VEGF-D RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778366|NCT01478594|O1|Outcome|Tivozanib: VEGF-D RNA < Median|Participants with VEGF-D RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778367|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778368|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778369|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A RNA ≥ Median|Participants with VEGF-C/VEGF-A RNA ratio ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778370|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A RNA < Median|Participants with VEGF-C/VEGF-A RNA ratio < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778371|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778372|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778373|NCT01478594|O2|Outcome|Tivozanib: VEGF-C RNA ≥ Median|Participants with VEGF-C RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778374|NCT01478594|O1|Outcome|Tivozanib: VEGF-C RNA < Median|Participants with VEGF-C RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778375|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778376|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778377|NCT01478594|O2|Outcome|Tivozanib: VEGF-A RNA ≥ Median|Participants with VEGF-A RNA levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778378|NCT01478594|O1|Outcome|Tivozanib: VEGF-A RNA < Median|Participants with VEGF-A RNA levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778379|NCT01478594|O4|Outcome|Bevacizumab: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778380|NCT01478594|O3|Outcome|Bevacizumab: Neuropilin < Median|Participants with neuropilin levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and FOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778381|NCT01478594|O2|Outcome|Tivozanib: Neuropilin ≥ Median|Participants with neuropilin levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778382|NCT01478594|O1|Outcome|Tivozanib: Neuropilin < Median|Participants with neuropilin levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778383|NCT01478594|O4|Outcome|Bevacizumab: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778384|NCT01478594|O3|Outcome|Bevacizumab: IL-8 < Median|Participants with IL-8 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778385|NCT01478594|O2|Outcome|Tivozanib: IL-8 ≥ Median|Participants with IL-8 levels ≥ median received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778386|NCT01478594|O1|Outcome|Tivozanib: IL-8 < Median|Participants with IL-8 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
779999|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
778387|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778388|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778389|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-3 ≥ Median|Participants with sVEGFR-3 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778390|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-3 < Median|Participants with sVEGFR-3 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778391|NCT01478594|O4|Outcome|Bevacizumab: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778392|NCT01478594|O3|Outcome|Bevacizumab: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778393|NCT01478594|O2|Outcome|Tivozanib: sVEGFR-2 ≥ Median|Participants with sVEGFR-2 levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778394|NCT01478594|O1|Outcome|Tivozanib: sVEGFR-2 < Median|Participants with sVEGFR-2 levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778395|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778396|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778397|NCT01478594|O2|Outcome|Tivozanib: VEGF-C/VEGF-A ≥ Median|Participants with VEGF-C/VEGF-A ratio ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778398|NCT01478594|O1|Outcome|Tivozanib: VEGF-C/VEGF-A < Median|Participants with VEGF-C/VEGF-A ratio < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778399|NCT01478594|O4|Outcome|Bevacizumab: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778400|NCT01478594|O3|Outcome|Bevacizumab: VEGF-C < Median|Participants with VEGF-C levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778401|NCT01478594|O2|Outcome|Tivozanib: VEGF-C ≥ Median|Participants with VEGF-C levels ≥ median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778402|NCT01478594|O1|Outcome|Tivozanib: VEGF-C < Median|Participants with VEGF-C levels < median received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778403|NCT01478594|O4|Outcome|Bevacizumab: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778404|NCT01478594|O3|Outcome|Bevacizumab: VEGF-A < Median|Participants with VEGF-A levels < median received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778405|NCT01478594|O2|Outcome|Tivozanib: VEGF-A ≥ Median|Participants with VEGF-A levels ≥ median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778406|NCT01478594|O1|Outcome|Tivozanib: VEGF-A < Median|Participants with VEGF-A levels < median received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778407|NCT01478594|O4|Outcome|Bevacizumab : LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778408|NCT01478594|O3|Outcome|Bevacizumab: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778409|NCT01478594|O2|Outcome|Tivozanib: LDH ≥ 1.5 ULN|Participants with LDH status ≥ 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778410|NCT01478594|O1|Outcome|Tivozanib: LDH < 1.5 ULN|Participants with LDH status < 1.5 ULN received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778635|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778411|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778412|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778442|NCT01478360|B1|Baseline|AIN457|AIN457 10 mg/kg
778413|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778414|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778415|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778416|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778417|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778418|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778419|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778420|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 m tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778421|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778422|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778423|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778424|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778425|NCT01478594|O2|Outcome|Bevacizumab + mFOLFOX6|Participants received 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle and mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778426|NCT01478594|O1|Outcome|Tivozanib + mFOLFOX6|Participants received 1.5 mg tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778427|NCT01478594|E2|Reported Event|Bevacizumab + mFOLFOX6|Participants received a dose of 5 mg/kg bevacizumab via intravenous infusion every 2 weeks on Days 1 and 15 of each cycle. Participants also received mFOLFOX6 chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778428|NCT01478594|E1|Reported Event|Tivozanib + mFOLFOX6|Participants received 1.5 mg of tivozanib orally once daily beginning on Day 1 of each cycle for 21 days followed by 7 days off treatment. Participants also received mFOLFOX6) chemotherapy every 2 weeks on Days 1 and 15 of each cycle.
778429|NCT01478373|B1|Baseline|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778430|NCT01478373|P1|Participant Flow|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778431|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778432|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778433|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778434|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778435|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778436|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778437|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778438|NCT01478373|O1|Outcome|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778439|NCT01478373|E1|Reported Event|Dovitinib|Patients received Dovitinib (TKI258) on an outpatient basis at the dose of 500 mg qd for 5 days followed by 2 days off, every week for cycle of 4 weeks (28d) until disease progression, unacceptable toxicity, or consent withdrawal.
778449|NCT01478347|B1|Baseline|rMenB+OMV NZ|"Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. 18 subjects were enrolled in part I of the study.~In part II of the study, subjects were re-enrolled for optional blood draws and safety follow-up. Of the 18 subjects enrolled in part I of the study, only 12 subjects continued participation into protocol part II of the study. Only 11 subjects (one subject was withdrawn after visit 3 due to lost to follow-up) were included in the safety set and therefore contributed to the baseline characteristics data."
778450|NCT01478347|P1|Participant Flow|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
778451|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
778452|NCT01478347|O1|Outcome|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of rMenB + OMV NZ vaccine, 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
778453|NCT01478347|E1|Reported Event|rMenB+OMV NZ|Healthy adults (≥18 to ≤65 years), at high risk for meningococcal B disease due to routine occupational exposure to N. Meningitidis cultures (e.g. lab workers), were administered two injections of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB + OMV NZ vaccine), 2 months apart, in part I of the study. In part II of the study subjects were re-enrolled for optional blood draws and safety follow-up.
778454|NCT01478256|B3|Baseline|Total|Total of all reporting groups
778455|NCT01478256|B2|Baseline|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
778456|NCT01478256|B1|Baseline|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
778457|NCT01478256|P2|Participant Flow|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
778458|NCT01478256|P1|Participant Flow|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
778459|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment twice a day for treatment of acute blepharitis
778460|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin twice a day to treat acute blepharitis
778461|NCT01478256|O2|Outcome|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
778462|NCT01478256|O1|Outcome|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
778463|NCT01478256|E2|Reported Event|Erythromycin|Topical Erythromycin ointment for treatment of acute blepharitis
778464|NCT01478256|E1|Reported Event|Besifloxocin|Use of topical besifloxocin to treat acute blepharitis
778465|NCT01478113|B3|Baseline|Total|Total of all reporting groups
778466|NCT01478113|B2|Baseline|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778467|NCT01478113|B1|Baseline|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778468|NCT01478113|P2|Participant Flow|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778540|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778541|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778469|NCT01478113|P1|Participant Flow|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778470|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778513|NCT01478009|P2|Participant Flow|Placebo|"Placebo(3times/day, 9capsules/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with KRG Extract."
778471|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778472|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778473|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778474|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778475|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778476|NCT01478113|O2|Outcome|WBT + Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778477|NCT01478113|O1|Outcome|WBT + Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine/dextroamphetamine: The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778478|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778479|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778480|NCT01478113|O2|Outcome|WBT + Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778481|NCT01478113|O1|Outcome|WBT + Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine/dextroamphetamine: The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778482|NCT01478113|O2|Outcome|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778483|NCT01478113|O1|Outcome|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778484|NCT01478113|E2|Reported Event|Well-being Therapy With Placebo|"In the placebo group, participants will receive treatment with Well-being therapy and pill placebo.~Placebo: The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778485|NCT01478113|E1|Reported Event|Well-being Therapy With Amphetamine/Dextroamphetamine|"In the active group, participants will receive treatment with Well-being therapy and amphetamine-dextroamphetamine.~Amphetamine-dextroamphetamine (AMPH): The amphetamine-dextroamphetamine will be in a pill formulation. The dosage of the amphetamine-dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.~Well-being therapy: Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit."
778486|NCT01478087|B1|Baseline|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
778487|NCT01478087|P1|Participant Flow|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
778488|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
778489|NCT01478087|O1|Outcome|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
778490|NCT01478087|E1|Reported Event|IA Treatment|The Mysorba device is an immunoadsorbent column. : Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
778491|NCT01478048|B3|Baseline|Total|Total of all reporting groups
778492|NCT01478048|B2|Baseline|Bortezomib + Dexamethasone|"Bortezomib: 1.3 mg/m^2 IV; (Cycles 1 - 8 on Days 1, 4, 8, 11; Cycles 9+ on Days 1, 8, 15.~Dexamethasone: 20 mg oral; (Cycles 1-8 QD on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ QD on Days 1, 2, 8, 9, 15, 16).~Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation."
778493|NCT01478048|B1|Baseline|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: 10 mg/kg Intravenous (IV): In Cycles 1 & 2: Treatment on Days 1, 8 & 15; In Cycles 3-8: on Days 1 & 11; In Cycle 9+: on Days 1 & 15.~Bortezomib: 1.3 mg/m^2 IV or subcutaneous; (Cycles 1 - 8: on Days 1, 4, 8, 11; Cycles 9+: on Days 1, 8, 15~Dexamethasone: On days of elotuzumab infusion, dexamethasone was administered as a split dose of 8mg oral 3 - 24 hours prior to elotuzumab followed by 8mg IV at least 45 minutes prior to elotuzumab. On other non-elotuzumab days, 20 mg oral dexamethasone was given once daily (QD) in Cycles 1 and 2 on Days 2, 4, 5, 9, 11; in Cycles 3 - 8 on Days 2, 4, 5, 8, 9, 12; in Cycles 9+ on Days 2, 8, 9, 16.~Participants were treated until disease progression, unacceptable toxicity, withdrawal of consent, or other criteria for discontinuation."
778494|NCT01478048|P2|Participant Flow|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778495|NCT01478048|P1|Participant Flow|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
778496|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778497|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
778498|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778636|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778499|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
818092|NCT01333397|O2|Outcome|Dysport NG 20 U|
778500|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778501|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
778502|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778503|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
778504|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778505|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
778506|NCT01478048|O2|Outcome|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778507|NCT01478048|O1|Outcome|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug~Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered~Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
778508|NCT01478048|E2|Reported Event|Bortezomib + Dexamethasone|"Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of study drug.~Dexamethasone: Tablets; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until criteria is met for discontinuation of study drug"
778542|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778637|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778509|NCT01478048|E1|Reported Event|Elotuzumab + Bortezomib + Dexamethasone|"Elotuzumab: Solution; IV; 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until participant meets criteria for discontinuation of drug Bortezomib: Solution; IV; 1.3 mg/m^2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until criteria met for discontinuation of drug.~Days of Elotuzumab infusion: Dexamethasone (8mg IV + 8mg Oral) administered. Other days Dexamethasone 20 mg Oral administered Dexamethasone: Tablets; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until criteria met for discontinuation.~Dexamethasone: Tablets; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation of drug. Dexamethasone: Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until criteria met for discontinuation"
778514|NCT01478009|P1|Participant Flow|KRG(Korean Red Ginseng) Extract|"KRG Extract(3times/day, 9capsules/day, 3g/day) for 12weeks~KRG Extract : KRG Extract was extracted at high temperatures (above 95℃)"
778515|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
778516|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
778517|NCT01478009|O2|Outcome|Placebo|Oral intake placebo(3.0g/day) for 12weeks
778518|NCT01478009|O1|Outcome|KRG Extract|Oral intake Korean red ginseng(3.0g/day) for 12weeks.
778519|NCT01478009|E2|Reported Event|Placebo|
778520|NCT01478009|E1|Reported Event|KRG Extract|
778521|NCT01477892|B3|Baseline|Total|Total of all reporting groups
778522|NCT01477892|B2|Baseline|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778523|NCT01477892|B1|Baseline|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778524|NCT01477892|P2|Participant Flow|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778525|NCT01477892|P1|Participant Flow|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778526|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778527|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778528|NCT01477892|O2|Outcome|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778529|NCT01477892|O1|Outcome|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778530|NCT01477892|E2|Reported Event|Low Dose Remifentanil|"continuous infusion of remifentanil 0.1mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778531|NCT01477892|E1|Reported Event|High Dose Remifentanil|"continuous infusion of remifentanil 0.25mcg/kg/min~low dose remifentanil : non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control"
778532|NCT01477853|B4|Baseline|Total|Total of all reporting groups
778533|NCT01477853|B3|Baseline|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778534|NCT01477853|B2|Baseline|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778535|NCT01477853|B1|Baseline|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778536|NCT01477853|P3|Participant Flow|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778537|NCT01477853|P2|Participant Flow|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778538|NCT01477853|P1|Participant Flow|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778539|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778543|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778544|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778545|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778546|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778641|NCT01477567|O5|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
778547|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778548|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778549|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778550|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778551|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778552|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778553|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778554|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778555|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778556|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778557|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778558|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778559|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778560|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778561|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778562|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778563|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778564|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778691|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo - inactive capsule
778565|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778566|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778567|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778642|NCT01477567|O4|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778643|NCT01477567|O3|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778568|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778569|NCT01477853|O3|Outcome|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778570|NCT01477853|O2|Outcome|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778571|NCT01477853|O1|Outcome|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778572|NCT01477853|E3|Reported Event|Sitagliptin + Atorvastatin/Sitagliptin + Atorvastatin|In Phase A, participants sitagliptin 100 mg plus atorvastatin 80 mg daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus atorvastatin 80 mg plus matching placebo to glimepiride daily for an additional 38 weeks.
778573|NCT01477853|E2|Reported Event|Atorvastatin/Atorvastatin + Glimepiride|In Phase A, participants received atorvastatin 80 mg plus matching placebo to sitagliptin daily for 16 weeks. Participants continuing to Phase B received atorvastatin 80 mg plus matching placebo to sitagliptin plus glimepiride daily for an additional 38 weeks.
778574|NCT01477853|E1|Reported Event|Sitagliptin/Sitagliptin + Atorvastatin|In Phase A, participants received sitagliptin 100 mg plus matching placebo to atorvastatin daily for 16 weeks. Participants continuing to Phase B received sitagliptin 100 mg plus matching placebo to glimepiride plus atorvastatin 80 mg daily for an additional 38 weeks.
778575|NCT01477762|B5|Baseline|Total|Total of all reporting groups
778576|NCT01477762|B4|Baseline|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778577|NCT01477762|B3|Baseline|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778578|NCT01477762|B2|Baseline|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778579|NCT01477762|B1|Baseline|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778580|NCT01477762|P4|Participant Flow|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778581|NCT01477762|P3|Participant Flow|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778582|NCT01477762|P2|Participant Flow|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778583|NCT01477762|P1|Participant Flow|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778584|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778633|NCT01477567|P1|Participant Flow|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778585|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778586|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778644|NCT01477567|O2|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
781124|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
778587|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778588|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778589|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778590|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778591|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778592|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778593|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778594|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778595|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778596|NCT01477762|O4|Outcome|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778597|NCT01477762|O3|Outcome|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778598|NCT01477762|O2|Outcome|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778599|NCT01477762|O1|Outcome|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778600|NCT01477762|E4|Reported Event|PTSD Positive: Dexamethasone First, Then Placebo|"Participants with PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778601|NCT01477762|E3|Reported Event|PTSD Positive: Placebo First, Then Dexamethosone|"Participants with PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778602|NCT01477762|E2|Reported Event|PTSD Negative: Dexamethasone First, Then Placebo|"Participants who do not have PTSD received dexamethasone then placebo for the duration of two consecutive study visits separated by at least one month.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments."
778603|NCT01477762|E1|Reported Event|PTSD Negative: Placebo First, Then Dexamethasone|"Participants who do not have PTSD received placebo then dexamethasone for the duration of two consecutive study visits separated by at least one month.~Placebo: One placebo tablet was taken ten hours prior to completing study assessments.~Dexamethasone: One tablet of 0.5 mg dexamethasone was taken ten hours prior to completing study assessments."
778645|NCT01477567|O1|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778646|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
778647|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778604|NCT01477749|B1|Baseline|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
778605|NCT01477749|P1|Participant Flow|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
778606|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
778607|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
778608|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
778609|NCT01477749|O1|Outcome|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
778610|NCT01477749|E1|Reported Event|Sipuleucel-T|"Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.~sipuleucel-T: Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals."
778611|NCT01477710|B1|Baseline|All Participants|Each clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Then, each will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, each will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
778612|NCT01477710|P1|Participant Flow|All Participants|Each participant will perform 3 tasks -- in the same order. First, the clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes. Next, the clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes. Finally, the clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
778613|NCT01477710|O3|Outcome|Airway|Using a supraglottic airway
778614|NCT01477710|O2|Outcome|Strap Mask|Mask is strapped to model using a securing device
778615|NCT01477710|O1|Outcome|Hold Mask|Mask is held in place by caregiver.
778616|NCT01477710|E3|Reported Event|Airway|
778617|NCT01477710|E2|Reported Event|Strap Mask|
778618|NCT01477710|E1|Reported Event|Hold Mask|
778619|NCT01477567|B8|Baseline|Total|Total of all reporting groups
778620|NCT01477567|B7|Baseline|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
778621|NCT01477567|B6|Baseline|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778622|NCT01477567|B5|Baseline|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778623|NCT01477567|B4|Baseline|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778624|NCT01477567|B3|Baseline|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778625|NCT01477567|B2|Baseline|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778626|NCT01477567|B1|Baseline|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778627|NCT01477567|P7|Participant Flow|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
778628|NCT01477567|P6|Participant Flow|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778629|NCT01477567|P5|Participant Flow|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778630|NCT01477567|P4|Participant Flow|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778631|NCT01477567|P3|Participant Flow|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778632|NCT01477567|P2|Participant Flow|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778638|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778639|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778640|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778648|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778649|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778650|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778651|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778652|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778653|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
778654|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778655|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778656|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778657|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778658|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778659|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778660|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778661|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778662|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778663|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778664|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778665|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778666|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778667|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778668|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778669|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778670|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778671|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778672|NCT01477567|O7|Outcome|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
778673|NCT01477567|O6|Outcome|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778674|NCT01477567|O5|Outcome|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778675|NCT01477567|O4|Outcome|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778676|NCT01477567|O3|Outcome|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778677|NCT01477567|O2|Outcome|1 mg LY3009385|LY3009385: 1 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778678|NCT01477567|O1|Outcome|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778679|NCT01477567|E7|Reported Event|Placebo|Placebo: saline, subcutaneous (SC) injection, single dose on Day 1
778680|NCT01477567|E6|Reported Event|54 mg LY3009385|LY3009385: 54 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778681|NCT01477567|E5|Reported Event|22 mg LY3009385|LY3009385: 22 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778682|NCT01477567|E4|Reported Event|9 mg LY3009385|LY3009385: 9 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778683|NCT01477567|E3|Reported Event|3 mg LY3009385|LY3009385: 3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778684|NCT01477567|E2|Reported Event|1 mg LY3009385|LY3009385: 1 milligram (mg), subcutaneous (SC) injection, single dose on Day 1
778685|NCT01477567|E1|Reported Event|0.3 mg LY3009385|LY3009385: 0.3 milligrams (mg), subcutaneous (SC) injection, single dose on Day 1
778686|NCT01477463|B3|Baseline|Total|Total of all reporting groups
778687|NCT01477463|B2|Baseline|Arm B: Placebo|Placebo - subjects may cross over to vitamin D treatment after placebo treatment is complete
778688|NCT01477463|B1|Baseline|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
778689|NCT01477463|P2|Participant Flow|Arm B: Placebo|Placebo - patients may cross over to vitamin D3 treatment after placebo treatment
778690|NCT01477463|P1|Participant Flow|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
778692|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
778693|NCT01477463|O2|Outcome|Arm B: Placebo|Placebo (inactive capsule)
778694|NCT01477463|O1|Outcome|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
778695|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
778696|NCT01477463|O1|Outcome|All Patients Treated With Vitamin D3|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
778697|NCT01477463|E2|Reported Event|Arm B: Placebo|Placebo (inactive capsule)
778698|NCT01477463|E1|Reported Event|Arm A: Vitamin D|"4,000 IU oral vitamin D3~Vitamin D3: 4,000 IU oral vitamin D3"
778699|NCT01477450|B4|Baseline|Total|Total of all reporting groups
778700|NCT01477450|B3|Baseline|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
779745|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
818093|NCT01333397|O1|Outcome|Placebo|
778701|NCT01477450|B2|Baseline|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778702|NCT01477450|B1|Baseline|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778703|NCT01477450|P3|Participant Flow|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778704|NCT01477450|P2|Participant Flow|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778705|NCT01477450|P1|Participant Flow|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778706|NCT01477450|O3|Outcome|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778707|NCT01477450|O2|Outcome|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778708|NCT01477450|O1|Outcome|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778709|NCT01477450|E3|Reported Event|3 L/Min ; 48 mL|"Cylinder oxygen delivery (3 L/min) followed by pulse-dose oxygen by concentrator (48 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778710|NCT01477450|E2|Reported Event|2 L/Min ; 32 mL|"Cylinder oxygen delivery (2 L/min) followed by pulse-dose oxygen by concentrator (32 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778711|NCT01477450|E1|Reported Event|1 L/Min ; 16 mL|"Cylinder oxygen delivery (1 L/min) followed by pulse-dose oxygen by concentrator (16 mL)~Pulse-dose oxygen: Pulsed-dose oxygen delivery from an oxygen concentrator~Cylinder oxygen delivery: Oxygen delivery from an oxygen cylinder"
778712|NCT01477333|B1|Baseline|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778713|NCT01477333|P1|Participant Flow|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778714|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778715|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778716|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778717|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778718|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778719|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778720|NCT01477333|O4|Outcome|Class III to Class III|UT-15C SR BID
778721|NCT01477333|O3|Outcome|Class III to Class II|UT-15C SR BID
778722|NCT01477333|O2|Outcome|Class II to Class III|UT-15C SR BID
778723|NCT01477333|O1|Outcome|Class II to Class II|UT-15C SR BID
778724|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778725|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778726|NCT01477333|O1|Outcome|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778727|NCT01477333|E1|Reported Event|UT-15C SR BID|UT-15C SR: Initiated at 0.125 mg BID, titrated as clinically indicated.
778728|NCT01475734|B3|Baseline|Total|Total of all reporting groups
778729|NCT01475734|B2|Baseline|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778730|NCT01475734|B1|Baseline|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778842|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
802569|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
778731|NCT01475734|P2|Participant Flow|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778732|NCT01475734|P1|Participant Flow|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778733|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778734|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778735|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778736|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778737|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778738|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778739|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778740|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778741|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778742|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778743|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778744|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778745|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778746|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778747|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778748|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778843|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778844|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778749|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778750|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778751|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778752|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778753|NCT01475734|O2|Outcome|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778754|NCT01475734|O1|Outcome|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778755|NCT01475734|E2|Reported Event|Placebo|Participants received a single dose of matching placebo (50 mg) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 mmol/L (162, 90, 72, 59, and 50.4 mg/dL, respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778756|NCT01475734|E1|Reported Event|Albiglutide 50 mg|Participants received a single dose of albiglutide (50 milligrams [mg]) subcutaneously 3 days before employing a stepped hyper- and hypoglycemic clamp with glucose plateaus of 9.0, 5.0, 4.0, 3.3, and 2.8 millimoles per liter (mmol/L) (162, 90, 72, 59, and 50.4 milligrams per deciliter [mg/dL], respectively). Glucose and insulin infusions were included as part of the clamp procedure.
778757|NCT01475721|B3|Baseline|Total|Total of all reporting groups
778758|NCT01475721|B2|Baseline|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778759|NCT01475721|B1|Baseline|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778760|NCT01475721|P2|Participant Flow|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778761|NCT01475721|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778762|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778763|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778764|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778765|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778766|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778767|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778768|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778769|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778770|NCT01475721|O2|Outcome|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778771|NCT01475721|O1|Outcome|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778772|NCT01475721|E2|Reported Event|Fluticasone Propionate (FP)|Participants received one of following treatments: FP 100 µg or FP 250 µg or FP 500 µg as one inhalation (BID) via (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778773|NCT01475721|E1|Reported Event|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg or FSC 500/50 µg as one inhalation twice daily (BID) via Dry powder inhaler (DPI) for 26 weeks. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment. Participants were instructed to stop using their current asthma medication.
778774|NCT01476748|B4|Baseline|Total|Total of all reporting groups
778775|NCT01476748|B3|Baseline|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778776|NCT01476748|B2|Baseline|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778777|NCT01476748|B1|Baseline|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778778|NCT01476748|P3|Participant Flow|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778779|NCT01476748|P2|Participant Flow|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778780|NCT01476748|P1|Participant Flow|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778781|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778782|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778783|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778784|NCT01476748|O3|Outcome|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778785|NCT01476748|O2|Outcome|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778786|NCT01476748|O1|Outcome|Covidien Versaport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778787|NCT01476748|E3|Reported Event|Storz Reusable Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778788|NCT01476748|E2|Reported Event|Ethicon Xcel Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778789|NCT01476748|E1|Reported Event|Covidien Veraport Trocars|LaproStop : One of the subject's trocars will be randomized to be used with a LaproStop device.
778790|NCT01476722|B1|Baseline|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
778791|NCT01476722|P1|Participant Flow|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
778792|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
778793|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
778794|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
778795|NCT01476722|O1|Outcome|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
778796|NCT01476722|E1|Reported Event|OPTI-FREE PureMoist|OPTI-FREE PureMoist multipurpose disinfecting solution used with study contact lenses on a daily wear basis for 30 days
778797|NCT01476696|B1|Baseline|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
780000|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
778798|NCT01476696|P3|Participant Flow|Part A Then Part B: Prasugrel Single Dose Then Once-Daily Dose|"Participants who enrolled in Part A and B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition."
779112|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
778799|NCT01476696|P2|Participant Flow|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel, administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
778800|NCT01476696|P1|Participant Flow|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
778801|NCT01476696|O1|Outcome|Part B: Prasugrel Once-Daily Dose|Part B: daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study.
778802|NCT01476696|O4|Outcome|Part B: Prasugrel Once-Daily Dose (0.12 mg/kg)|Participants who received 0.12 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
778803|NCT01476696|O3|Outcome|Part B: Prasugrel Once-Daily Dose (0.08 mg/kg)|Participants who received 0.08 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
778804|NCT01476696|O2|Outcome|Part B: Prasugrel Once-Daily Dose (0.06 mg/kg)|Participants who received 0.06 mg/kg Prasugrel administered orally, ODT, once daily, anytime (first or second dosing period) during Part B of the study, for a total of up to 36 days.
778805|NCT01476696|O1|Outcome|Part B: Baseline|Participants in Part B of the study, prior to receiving treatment (Prasugrel once-daily doses).
778806|NCT01476696|O1|Outcome|Part A: Prasugrel Single Dose|Part A of the study: 0.03 up to 0.60 milligrams per kilogram (mg/kg) Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses.
778807|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
778808|NCT01476696|O1|Outcome|Entire Study Population|"Participants enrolled in Part A, Part A and B, or only Part B of study. Part A: 0.03 up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period in Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then PD response measured 4 hours later. Based on 4-hour PD response, each participant assigned to 0.08 or 0.06 mg/kg Prasugrel once daily for remainder of first dosing period. For second 14 ± 4-day period, participants assigned to 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on steady-state PD response at end of first dosing period, so that the second dose would be unlikely to exceed 50% platelet inhibition."
778845|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778846|NCT01476475|E2|Reported Event|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
778847|NCT01476475|E1|Reported Event|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted (median exposure: 169 days).
778848|NCT01476345|B1|Baseline|All Participants|A single 0.5 units/kilogram (U/kg) dose of LY2963016 or a single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778809|NCT01476696|E4|Reported Event|Part A and Part B Participants: During Part B|"Events reported during Part B for those participants who enrolled in Part A and Part B of study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
779272|NCT01475838|B3|Baseline|Total|Total of all reporting groups
778810|NCT01476696|E3|Reported Event|Part A and Part B Participants: During Part A|"Events reported during Part A for those participants who enrolled in Part A and Part B of study.~Part A: 0.03 mg/kg up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally, ODT, up to 3 times, at different mg/kg doses, with up to 18 days between doses."
778811|NCT01476696|E2|Reported Event|Part B: Prasugrel Once-Daily Dose|"Participants who only enrolled in Part B of the study.~Part B: Daily Prasugrel dose (mg/kg) expected to achieve mean platelet activation inhibition of 30%, administered orally, ODT, once daily for 14 ± 4 days (first dosing period during Part B). Initial dose, 0.08 mg/kg Prasugrel, administered then pharmacodynamic (PD) response measured 4 hours later. Based on 4-hour PD response, each participant assigned to either 0.08 or 0.06 mg/kg Prasugrel administered orally, once daily for the remainder of the first dosing period in Part B. For the second continuous 14 ± 4-day period, participants were administered 1 of 3 possible doses: 0.06, 0.08, or 0.12 mg/kg depending on their steady-state PD response at the end of the first dosing period, such that the second dose would be unlikely to exceed 50% platelet inhibition. Participants received study drug for a total of 28 ± 8 days during Part B of the study."
778812|NCT01476696|E1|Reported Event|Part A: Prasugrel Single Dose|"Participants who only enrolled in Part A of the study.~Part A: 0.03 milligrams per kilogram (mg/kg) up to 0.60 mg/kg Prasugrel, each dose titrated up or down for each participant in order to achieve desired platelet inhibition (20% to 50%). Single dose administered orally [oral-disintegrating tablet (ODT)] up to 3 times, at different mg/kg doses, with up to 18 days between doses."
778813|NCT01476475|B3|Baseline|Total|Total of all reporting groups
778814|NCT01476475|B2|Baseline|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778815|NCT01476475|B1|Baseline|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778816|NCT01476475|P2|Participant Flow|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778817|NCT01476475|P1|Participant Flow|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously once daily (QD) for 24 weeks. Dose individually adjusted.
778818|NCT01476475|O2|Outcome|Insulin Glargine (Lantus® SoloSTAR®)|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778819|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778820|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778821|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778822|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778823|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778824|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778825|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778826|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778827|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778828|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778829|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778830|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778831|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778832|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778833|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778834|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778835|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778836|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778837|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778838|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778839|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778840|NCT01476475|O2|Outcome|Insulin Glargine|Insulin glargine injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778841|NCT01476475|O1|Outcome|Insulin Glargine/Lixisenatide Fixed Ratio Combination|FRC injected subcutaneously QD for 24 weeks. Dose individually adjusted.
778849|NCT01476345|P2|Participant Flow|Lantus/LY/Lantus/LY|"Sequence 2: A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of LY2963016 administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
778850|NCT01476345|P1|Participant Flow|LY/Lantus/LY/Lantus|"Sequence 1: A single 0.5 units/kilogram (U/kg) dose of LY2963016 (LY) administered subcutaneously during Periods 1 and 3.~A single 0.5 U/kg dose of Lantus administered subcutaneously during Periods 2 and 4.~Minimum washout interval of 7 days between each period."
778851|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
779542|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
778852|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778853|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778854|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778855|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778856|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778857|NCT01476345|O2|Outcome|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778858|NCT01476345|O1|Outcome|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778859|NCT01476345|E2|Reported Event|Lantus|A single 0.5 U/kg dose of Lantus administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778860|NCT01476345|E1|Reported Event|LY2963016|A single 0.5 units/kilogram (U/kg) dose of LY2963016 administered subcutaneously followed by minimum washout interval of 7 days during 2 of 4 study periods in each sequence.
778861|NCT01476202|B4|Baseline|Total|Total of all reporting groups
778862|NCT01476202|B3|Baseline|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
778863|NCT01476202|B2|Baseline|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
778864|NCT01476202|B1|Baseline|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
778865|NCT01476202|P3|Participant Flow|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
778866|NCT01476202|P2|Participant Flow|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
778867|NCT01476202|P1|Participant Flow|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
778868|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
778869|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
778870|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 Milligram (mg)|Participants self administered single dose of 2.5 mg nicotine mouth strip.
778871|NCT01476202|O3|Outcome|Nicotine Gum 2 mg|Participants self administered a single dose of 2 mg nicotine gum.
778872|NCT01476202|O2|Outcome|Nicotine Lozenge 2 mg|Participants self administered a single dose of 2 mg nicotine lozenge.
778873|NCT01476202|O1|Outcome|Nicotine Mouth Strip 2.5 mg|Participants self administered a single dose of 2.5 mg nicotine mouth strip.
778874|NCT01476202|E3|Reported Event|Nicotine Gum 2 mg|Participants self administered single dose of 2 mg nicotine gum.
778875|NCT01476202|E2|Reported Event|Nicotine Lozenge 2 mg|Participants self administered single dose of 2 mg nicotine lozenge.
778876|NCT01476202|E1|Reported Event|Nicotine Mouth Strip 2.5 mg|Participants self administered single dose of 2.5 mg nicotine mouth strip.
778877|NCT01475955|B6|Baseline|Total|Total of all reporting groups
778878|NCT01475955|B5|Baseline|Vehicle (VEH) + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visit 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778879|NCT01475955|B4|Baseline|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
778880|NCT01475955|B3|Baseline|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
778881|NCT01475955|B2|Baseline|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
778882|NCT01475955|B1|Baseline|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
778883|NCT01475955|P5|Participant Flow|Vehicle + BLUE Light Treatment|"Vehicle (VEH) group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle (VEH) Photodynamic Therapy (PDT) : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779533|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
778884|NCT01475955|P4|Participant Flow|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
778885|NCT01475955|P3|Participant Flow|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
778886|NCT01475955|P2|Participant Flow|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
778887|NCT01475955|P1|Participant Flow|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5
778888|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778889|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778890|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778891|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778892|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778893|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778894|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778895|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778896|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778897|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778898|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778899|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778900|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778901|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778902|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778903|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778904|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778905|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778906|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778907|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778908|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778909|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778910|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778911|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778912|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
818094|NCT01333397|O5|Outcome|Dysport 50 U|
778913|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778914|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778915|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778916|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778917|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778918|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778919|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778920|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778921|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778922|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778923|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778924|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778925|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778926|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778927|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778928|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778929|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778930|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778931|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778932|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778933|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
803415|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
778934|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778935|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778936|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778937|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778938|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778939|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778940|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778941|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778942|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778943|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778944|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778945|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778946|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778947|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778948|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778949|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778950|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778951|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778952|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778953|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778954|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778955|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778956|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778957|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778958|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
803416|NCT01385293|E1|Reported Event|BKM 120|BKM120 at 100mg orally daily
778959|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778960|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778961|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778962|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778963|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778964|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778965|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778966|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778967|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778968|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778969|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778970|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778971|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778972|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778973|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778974|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778975|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778976|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778977|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778978|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778979|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778980|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778981|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778982|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778983|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
803887|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
778984|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778985|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778986|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778987|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778988|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778989|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778990|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778991|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778992|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778993|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778994|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778995|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778996|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778997|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
778998|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
778999|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779000|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779001|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779002|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779003|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779004|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779005|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779006|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779007|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779008|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
803992|NCT01382186|B3|Baseline|Total|Total of all reporting groups
779009|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779010|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779011|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779012|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779013|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779014|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779015|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779016|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779017|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779018|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779019|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779020|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779021|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779022|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779023|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779024|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779025|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779026|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779027|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779028|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779029|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779030|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779031|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779032|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779033|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
807351|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
779034|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779035|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779036|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779037|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779038|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779039|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779040|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779041|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779042|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779043|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779044|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779045|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779046|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779047|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779048|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779049|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779050|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779051|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779052|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779053|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779054|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779055|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
779056|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779057|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779058|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
807352|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
779059|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779060|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779061|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment at Visit 1 and Vi|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779543|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779062|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779063|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779064|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779065|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779066|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779067|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779068|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779069|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779070|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779071|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779072|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779073|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779074|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779075|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779076|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779077|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779078|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779079|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779080|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779081|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779082|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779083|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779084|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779085|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779086|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
818095|NCT01333397|O4|Outcome|Dysport NG 75 U|
779087|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779088|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779089|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779090|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779091|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Visit 1 and Visit 5
779092|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779093|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779094|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779095|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779096|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779097|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779098|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779099|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779100|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779101|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779102|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779103|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779104|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779105|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779106|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779107|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779108|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779534|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779109|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779110|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779111|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779113|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779114|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779115|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779116|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779117|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779118|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779119|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779120|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779121|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779122|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779123|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779124|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779125|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779126|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779127|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779128|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779129|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779130|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779131|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779132|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779133|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779535|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779134|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779135|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779136|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779137|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779138|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779139|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779140|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779141|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779142|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779143|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779144|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779145|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779146|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779147|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779148|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779149|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779150|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779151|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779152|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779153|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779154|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779155|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779156|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779157|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779158|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779536|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779159|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779160|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779161|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779162|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779163|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779164|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779165|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779166|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779167|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779168|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779169|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779170|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779171|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779172|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779173|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779174|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779175|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779176|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779177|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779178|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5 . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779179|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779180|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779181|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779182|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779183|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Vist 1 and Visit 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779537|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779184|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779185|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779186|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation prior to BLUE light treatment at Vist 1 and Visit 5
779187|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779188|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment, at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779189|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779190|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779191|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visit 1 and Visit 5
779192|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Vist 1 and Visit 5
779193|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779194|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779195|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779196|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779197|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779198|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779199|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779200|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779201|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779202|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779203|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779204|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779205|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779206|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779207|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779208|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group were randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779538|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779209|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779210|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779211|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779212|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779213|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779214|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779215|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779216|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779217|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779218|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5. . Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779219|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779220|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779221|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779222|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779223|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779224|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779225|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779226|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation,prior to BLUE light treatment at Visits 1 and 5.
779227|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779228|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779229|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779230|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779231|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779232|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779233|NCT01475955|O5|Outcome|Vehicle + BLUE Light Treatment|"VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment at Visits 1 and 5.. Subjects receiving VEH were considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group was randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH were considered a single treatment group."
779539|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779234|NCT01475955|O4|Outcome|Spot ALA 2-hour + BLUE Light Treatment|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779235|NCT01475955|O3|Outcome|Broad Area ALA 3-hour + BLUE Light Treatment|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779236|NCT01475955|O2|Outcome|Broad Area ALA 2-hour + BLUE Light Treatment|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779237|NCT01475955|O1|Outcome|Broad Area ALA 1-hour + BLUE Light Treatment|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation, prior to BLUE light treatment at Visits 1 and 5.
779238|NCT01475955|E5|Reported Event|Vehicle PDT|"VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.~Vehicle PDT : Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group."
779239|NCT01475955|E4|Reported Event|Spot ALA 2-hour|Spot application ALA 2 hour incubation : 20% ALA spot application 2 hour incubation
779240|NCT01475955|E3|Reported Event|Broad Area ALA 3-hour|broad area ALA 3-hour incubation : 20% ALA broad area 3 hour incubation
779241|NCT01475955|E2|Reported Event|Broad Area ALA 2-hour|Broad Area ALA 2-hr incubation : 20% ALA broad area 2-hour incubation
779242|NCT01475955|E1|Reported Event|Broad Area ALA 1-hour|Broad Area ALA 1-hour incubation : 20% ALA, broad area, 1 hour incubation
779243|NCT01475851|B3|Baseline|Total|Total of all reporting groups
779244|NCT01475851|B2|Baseline|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779245|NCT01475851|B1|Baseline|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779246|NCT01475851|P2|Participant Flow|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779247|NCT01475851|P1|Participant Flow|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779248|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779249|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779250|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779251|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779252|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779253|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779254|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779255|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779256|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779257|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779258|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779259|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779260|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779261|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779262|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779263|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779264|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779265|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779266|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779267|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779268|NCT01475851|O2|Outcome|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779269|NCT01475851|O1|Outcome|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779270|NCT01475851|E2|Reported Event|ETV 0.5 mg/TDF 300 mg|Participants received a single, OL entecavir (ETV) 0.5 mg tablet OD and a single, OL TDF 300 mg tablet OD for 96 weeks.
779271|NCT01475851|E1|Reported Event|LAM 100 mg/TDF 300 mg|Participants received a single, Open-Label (OL) Lamivudine (LAM) 100 milligram (mg) tablet once daily (OD) and a single, OL tenofovir disoproxil fumarate (TDF) 300 mg tablet OD for 96 weeks.
779273|NCT01475838|B2|Baseline|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
779274|NCT01475838|B1|Baseline|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
779275|NCT01475838|P2|Participant Flow|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a protease inhibitor (PI) (atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)) boosted with ritonavir (RTV) plus emtricitabine (FTC)/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
779276|NCT01475838|P1|Participant Flow|Stribild|Participants switched from their baseline treatment regimen to Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
779277|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
779278|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
779279|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
779280|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
779281|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
779282|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
779283|NCT01475838|O2|Outcome|PI+RTV+FTC/TDF|Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase.
779284|NCT01475838|O1|Outcome|Stribild|Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase.
779285|NCT01475838|E3|Reported Event|All Stribild|Adverse events for this reporting group include those occurring in participants while receiving Stribild in the randomized and extension phases.
779286|NCT01475838|E2|Reported Event|PI+RTV+FTC/TDF|"Adverse events for this reporting group include those occurring in participants receiving PI+RTV+FTC/TDF in the randomized phase.~Participants stayed on their baseline treatment regimen consisting of a PI (ATV, DRV, FPV, LPV, or SQV) boosted with RTV plus FTC/TDF (200/300 mg) (administered according to prescribing information) for up to 96 weeks in the randomized phase, and may have switched to Stribild in the extension phase."
779287|NCT01475838|E1|Reported Event|Stribild|"Adverse events for this reporting group include those occurring in participants receiving Stribild in the randomized phase.~Participants switched from their baseline treatment regimen to Stribild (E/C/F/TDF) (150/150/200/300 mg) STR once daily for up to 96 weeks in the randomized phase, and may have continued to receive Stribild in the extension phase."
779288|NCT01475487|B3|Baseline|Total|Total of all reporting groups
779289|NCT01475487|B2|Baseline|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
779290|NCT01475487|B1|Baseline|Cricothyrotomy Using Digital Palpation|"Group-1 will perform Cricothyrotomy using conventional digital palpation technique~Utrasound guided cricothyrotomy: Utrasound guided cricothyrotomy"
779300|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
779329|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779540|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779291|NCT01475487|P2|Participant Flow|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
779292|NCT01475487|P1|Participant Flow|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
779293|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
779294|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
779295|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
779296|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
779297|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
779298|NCT01475487|O1|Outcome|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
779299|NCT01475487|O2|Outcome|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
779328|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779524|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779301|NCT01475487|E2|Reported Event|Ultrasound Guided Cricothyrotomy Group|"Group-2 Ultrasound guided cricothyrotomy A 15-10 mHz linear probe (MicroMaxx system, Sonosite Canada Inc, Markham, Ontario, Canada) was used to obtain sonographic images of anatomical landmarks on cadaveric necks as described by Kristensen.~The participants held the linear high-frequency transducer in their non-dominant hand and placed themselves on the right side of the cadaver facing towards the head of the cadaver. Then they placed the US probe transversely over the cadaver’s neck just above the suprasternal notch in order to visualize the trachea. The transducer was then moved laterally to the patient’s right side until the right border of the transducer was superficial to the midline of the trachea. During this movement it was ensured that the right end of the transducer was kept in the midline of the trachea while the left end of the transducer was rotated into the sagittal plane resulting in a longitudinal scan of the midline of the trachea."
779302|NCT01475487|E1|Reported Event|Cricothyrotomy Using Digital Palpation|"Group-1 will perform cricothyrotomy using conventional digital palpation technique~The identification of the cricothyroid membrane by digital palpation was performed by using the index and third fingers of the non-dominant hand. The thyroid cartilage was first palpated in the midline starting from cephalad and moving caudally until the cricoid cartilage is palpated. The is the space between the inferior border of the thyroid cartilage and the superior border of the cricoid cartilage"
779303|NCT01475474|B1|Baseline|Renew Insert for Management of Accidental Bowel Leakage|
779304|NCT01475474|P1|Participant Flow|Renew Insert for Management of Accidental Bowel Leakage|The Renew Insert is designed for self-insertion to seal and help prevent involuntary leakage of stool from the rectum. The Insert is designed for single use and consists of two components: a soft, easily deformable silicone insert and a flexible plastic fingertip applicator. After self insertion into the anal canal the Insert is expelled with voluntary bowel movement or if desired, manually removed by the user.
779305|NCT01475474|O1|Outcome|Modified Intent to Treat Cohort (MITT)|Modified Intent-to-Treat cohort included all subjects who completed at least one week of Insert use during the 12 Week Treatment Period.
779306|NCT01475474|O1|Outcome|Modified Intent-To-Treat Cohort|Modified Intent-to-Treat cohort included all subjects who completed week one and up to week 12 during the 12-Week Treatment Period.
779307|NCT01475474|E1|Reported Event|Intent-to-treat (ITT) Cohort|Subjects who used the Renew Insert.
779308|NCT01475461|B7|Baseline|Total|Total of all reporting groups
779309|NCT01475461|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779310|NCT01475461|B5|Baseline|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779311|NCT01475461|B4|Baseline|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779312|NCT01475461|B3|Baseline|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779313|NCT01475461|B2|Baseline|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779314|NCT01475461|B1|Baseline|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779315|NCT01475461|P7|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779316|NCT01475461|P6|Participant Flow|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779317|NCT01475461|P5|Participant Flow|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779318|NCT01475461|P4|Participant Flow|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779319|NCT01475461|P3|Participant Flow|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779320|NCT01475461|P2|Participant Flow|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779321|NCT01475461|P1|Participant Flow|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
779322|NCT01475461|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779323|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779324|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779325|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779326|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779327|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779525|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779330|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779331|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779332|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779333|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
818096|NCT01333397|O3|Outcome|Dysport NG 50 U|
779334|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779335|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779336|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779337|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779338|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779339|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779340|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
779341|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779342|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779343|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779344|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779345|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779346|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779347|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
779348|NCT01475461|O7|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779349|NCT01475461|O6|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779350|NCT01475461|O5|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779351|NCT01475461|O4|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779352|NCT01475461|O3|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779353|NCT01475461|O2|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779354|NCT01475461|O1|Outcome|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
779355|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779356|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779357|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779358|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779359|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779360|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
807353|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
779361|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779362|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779363|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779364|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779365|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779366|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779367|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779368|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779369|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779370|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779371|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779372|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779373|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779374|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779375|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779376|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779377|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779378|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779379|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779380|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779381|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779382|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779383|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779384|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779385|NCT01475461|O6|Outcome|Sitagliptin|Sitagliptin 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779386|NCT01475461|O5|Outcome|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779387|NCT01475461|O4|Outcome|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779388|NCT01475461|O3|Outcome|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779389|NCT01475461|O2|Outcome|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779390|NCT01475461|O1|Outcome|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779391|NCT01475461|E7|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally tablet once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779392|NCT01475461|E6|Reported Event|PF-04937319 100 mg|PF-04937319 100 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779393|NCT01475461|E5|Reported Event|PF-04937319 50 mg|PF-04937319 50 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779394|NCT01475461|E4|Reported Event|PF-04937319 20 mg|PF-04937319 20 mg tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779395|NCT01475461|E3|Reported Event|PF-04937319 3 mg|PF-04937319 3 mg tablet orally once daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice, for 12 weeks.
779396|NCT01475461|E2|Reported Event|Placebo|Placebo matched to PF-04937319 tablet orally once daily and placebo matched to sitagliptin tablet orally once daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice, for 12 weeks.
779397|NCT01475461|E1|Reported Event|Metformin 500 mg|Metformin 500 milligram (mg) immediate release tablet used as standardized, pre-specified background therapy in all participants initiated at the run-in visit and continued till follow-up visit.
779398|NCT01475253|B4|Baseline|Total|Total of all reporting groups
779399|NCT01475253|B3|Baseline|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
779400|NCT01475253|B2|Baseline|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779401|NCT01475253|B1|Baseline|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779402|NCT01475253|P4|Participant Flow|LiRIS® 400 mg - Open Label Extension|LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine. All subjects who completed the randomized study had the option to enter the open label extension.
779403|NCT01475253|P3|Participant Flow|Sham Cystoscopic Procedure-Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
779404|NCT01475253|P2|Participant Flow|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779405|NCT01475253|P1|Participant Flow|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779406|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779407|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779408|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779409|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779410|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779411|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779412|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779413|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779414|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779415|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779416|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779526|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779417|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779418|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779419|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779420|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779421|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779422|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779423|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779424|NCT01475253|O2|Outcome|LiRIS® Placebo-Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS® investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779425|NCT01475253|O1|Outcome|LiRIS® 400 Mg-Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779426|NCT01475253|E4|Reported Event|LiRIS 400 mg - Open Label Extension|"LiRIS® 400 mg is a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine.~All subjects who completed the randomized study had the option to enter the open lable extension."
779427|NCT01475253|E3|Reported Event|Sham Cystoscopic Procedure - Randomized Study|"Single-blinded sham arm of subjects who underwent cystoscopic insertion and retrieval procedures without any placement or removal of investigational product or placebo."
779428|NCT01475253|E2|Reported Event|LiRIS® Placebo - Randomized Study|LiRIS® Placebo, the matching placebo for the LiRIS investigational product containing lactose as the drug surrogate, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779429|NCT01475253|E1|Reported Event|LiRIS® 400 mg - Randomized Study|LiRIS® 400 mg, a non-resorbable intravesical drug-device combination investigational product that contains 400 mg of lidocaine, was inserted into the bladder using a standard cystoscopic procedure on Baseline Study Day 0 and was removed from the bladder on Day 14.
779430|NCT01475214|B4|Baseline|Total|Total of all reporting groups
779431|NCT01475214|B3|Baseline|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
779432|NCT01475214|B2|Baseline|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779433|NCT01475214|B1|Baseline|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779434|NCT01475214|P3|Participant Flow|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
779435|NCT01475214|P2|Participant Flow|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779436|NCT01475214|P1|Participant Flow|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779437|NCT01475214|O3|Outcome|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
779438|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779439|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779440|NCT01475214|O3|Outcome|Inactive Placebo Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
779441|NCT01475214|O2|Outcome|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779527|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779528|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779442|NCT01475214|O1|Outcome|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779443|NCT01475214|E3|Reported Event|Inactive Capsule|"microcrystalline cellulose~placebo: microcrystalline cellulose"
779444|NCT01475214|E2|Reported Event|Potassium Bicarbonate Higher Dose|"potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779544|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
818097|NCT01333397|O2|Outcome|Dysport NG 20 U|
779445|NCT01475214|E1|Reported Event|Potassium Bicarbonate Low Dose|"potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water~potassium bicarbonate: potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water"
779446|NCT01475175|B1|Baseline|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779447|NCT01475175|P1|Participant Flow|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779448|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779449|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779450|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779451|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779452|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779453|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779454|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779455|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779456|NCT01475175|O1|Outcome|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779457|NCT01475175|E1|Reported Event|Adaptive CRT Pacing|Cardiac resynchronization therapy (CRT) with adaptive pacing.
779458|NCT01475097|B3|Baseline|Total|Total of all reporting groups
779459|NCT01475097|B2|Baseline|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779460|NCT01475097|B1|Baseline|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779461|NCT01475097|P2|Participant Flow|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779462|NCT01475097|P1|Participant Flow|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779463|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779464|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779465|NCT01475097|O2|Outcome|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779466|NCT01475097|O1|Outcome|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779467|NCT01475097|E2|Reported Event|Iopamidol 370mgI/mL|Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779468|NCT01475097|E1|Reported Event|Iodixanol 320mgI/mL|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
779469|NCT01475071|B1|Baseline|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
779470|NCT01475071|P1|Participant Flow|All Subjects Enrolled|Intra-individual Comparison: all subjects have received Metvix and daylight photodynamic therapy on one side and Metvix and conventional photodynamic therapy on the other side
779471|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
779472|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
779473|NCT01475071|O2|Outcome|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
779474|NCT01475071|O1|Outcome|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
779475|NCT01475071|E2|Reported Event|Metvix and Lamp|Metvix and conventional Phototodynamic Therapy
779476|NCT01475071|E1|Reported Event|Metvix and Daylight|Metvix and daylight Photodynamic Therapy
779477|NCT01474993|B3|Baseline|Total|Total of all reporting groups
779478|NCT01474993|B2|Baseline|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane.
779479|NCT01474993|B1|Baseline|Placebo|15 participants were randomized to placebo.
779480|NCT01474993|P2|Participant Flow|Sulforaphane-rich Broccoli Sprout Extract|"29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study.~Sulforaphane-rich Broccoli Sprout Extract: The medication was supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane depended on subject's body weight:~Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)~Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)~Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)"
779481|NCT01474993|P1|Participant Flow|Placebo|15 participants were randomized to placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose).One participant in placebo group dropped out before starting study drug. 14 participants completed the study.
779529|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779482|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
818098|NCT01333397|O1|Outcome|Placebo|
779483|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779484|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779485|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779486|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779487|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779488|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779489|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779490|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779491|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779492|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779530|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779493|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779545|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779494|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779495|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779496|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779497|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779498|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient's body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 - 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779499|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient's body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 - 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779500|NCT01474993|O2|Outcome|Sulforaphane-rich Broccoli Sprout Extract|Patients were treated for 18 weeks (from the second [randomization] visit until the 18 week visit). Sulforaphane was supplied and dispensed as no.1 size gel caps (each gel cap containing ~ 250 mg Sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of Sulforaphane). The dosage of Sulforaphane was based on the patient’s body weight: ~50 µmol Sulforaphane (1 gel cap per day) for patients with weight ≤ 100 lbs; ~100 µmol Sulforaphane (2 gel caps per day) for patients with weight 101 – 199 lbs; ~150 µmol Sulforaphane (3 gel caps per day) for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779501|NCT01474993|O1|Outcome|Placebo|Patients were treated for 18 weeks (from the second [baseline] visit until the 18 week visit). The placebo was supplied and dispensed as no.1 size gel caps (each gel cap containing microcrystalline cellulose) identical in size, appearance and color to capsules containing sulforaphane. The dosage of placebo was based on the patient’s body weight: 1 gel cap per day for patients with weight ≤ 100 lbs; 2 gel caps per day for patients with weight 101 – 199 lbs; 3 gel caps per day for patients with weight ≥ 200 lbs. Route of administration: oral. Frequency of administration: once a day.
779502|NCT01474993|E2|Reported Event|Sulforaphane-rich Broccoli Sprout Extract|29 subjects were randomized to receive sulforaphane-rich Broccoli Sprout Extract. Of these, 2 were lost to follow up and 1 discontinued intervention. 26 sulforaphane participants completed the study and were analyzed.
779503|NCT01474993|E1|Reported Event|Placebo|15 participants were randomized to placebo. One participant in placebo group dropped out before starting study drug. 14 participants completed the study and were analyzed.
779504|NCT01474915|B3|Baseline|Total|Total of all reporting groups
779505|NCT01474915|B2|Baseline|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
779531|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
807354|NCT01369745|E5|Reported Event|Placebo|placebo once daily
779546|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779547|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779548|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779549|NCT01474876|O1|Outcome|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779550|NCT01474876|E1|Reported Event|Overall Study Population|Participants who received adalimumab treatment
779506|NCT01474915|B1|Baseline|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
779507|NCT01474915|P2|Participant Flow|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
779508|NCT01474915|P1|Participant Flow|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
779509|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
779510|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
779511|NCT01474915|O2|Outcome|Ondansetron|"Ondansetron is given via intravenous (IV), along with an oral (PO) or IV placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject receives 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
779512|NCT01474915|O1|Outcome|Aprepitant|"Aprepitant is given orally (PO), along with an oral or PO placebo depending on their group assignment for uniformity. Each patient receives three drugs in their respective triple prophylactic medication plus an intravenous (IV) or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject receives 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject receives 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject receives 25 mg of Promethazine IV around anesthesia induction"
779513|NCT01474915|E2|Reported Event|Ondansetron|"Ondansetron is given via IV, along with an oral or IV placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication (25mg promethazine, 10mg dexamethasone, and either 4mg ondansetron or 40mg aprepitant) plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy~4mg Ondansetron IV + PO placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Ondansetron : Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
779514|NCT01474915|E1|Reported Event|Aprepitant|"Aprepitant is given orally, along with an oral or PO placebo depending on their group assignment for uniformity. Each patient will receive three drugs in their respective triple prophylactic medication plus an IV or oral placebo prior to induction of anesthesia.~Triple therapy 40mg Aprepitant PO + IV placebo, 25mg Promethazine IV and 10mg dexamethasone IV~Aprepitant : Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction~Dexamethasone : Subject will receive 10 mg of Dexamethasone IV around anesthesia induction~Promethazine : Subject will receive 25 mg of Promethazine IV around anesthesia induction"
779515|NCT01474876|B4|Baseline|Total|Total of all reporting groups
779516|NCT01474876|B3|Baseline|Disease State Unknown|For one participant, information regarding the underlying disease was not available
779517|NCT01474876|B2|Baseline|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779518|NCT01474876|B1|Baseline|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779519|NCT01474876|P3|Participant Flow|Disease State Unknown|For one participant, information regarding the underlying disease was not available
779520|NCT01474876|P2|Participant Flow|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779521|NCT01474876|P1|Participant Flow|Ankylosing Spondylitis|Participants with a diagnosis of ankylosing spondylitis
779522|NCT01474876|O1|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779523|NCT01474876|O2|Outcome|Psoriatic Arthritis|Participants with a diagnosis of psoriatic arthritis
779552|NCT01474863|B3|Baseline|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
779553|NCT01474863|B2|Baseline|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
779554|NCT01474863|B1|Baseline|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
779555|NCT01474863|P3|Participant Flow|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
779556|NCT01474863|P2|Participant Flow|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
779557|NCT01474863|P1|Participant Flow|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
779558|NCT01474863|O3|Outcome|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
779559|NCT01474863|O2|Outcome|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
779560|NCT01474863|O1|Outcome|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
779561|NCT01474863|E3|Reported Event|High Dose Citrulline|"High Dose Citrulline~High Dose Citrulline: Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days"
779562|NCT01474863|E2|Reported Event|Placebo|"Placebo IV infusion~Placebo: D5W IV fluids at isovolumetric rate (about 15ml/hr)"
779563|NCT01474863|E1|Reported Event|Low Dose Citrulline|"Low Dose Citrulline~Low Dose Citrulline: Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days."
779564|NCT01474772|B3|Baseline|Total|Total of all reporting groups
779565|NCT01474772|B2|Baseline|Placebo/Pregabalin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779566|NCT01474772|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779567|NCT01474772|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779568|NCT01474772|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (2 week dose titration [starting dose: 150 mg/day] and 4 weeks fixed dose [150 - 300 mg/day]) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779659|NCT01474681|E3|Reported Event|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779660|NCT01474681|E2|Reported Event|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779661|NCT01474681|E1|Reported Event|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779569|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779663|NCT01474551|P1|Participant Flow|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
779746|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779570|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779571|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779572|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779573|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779574|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779575|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779576|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779577|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779578|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779579|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779733|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779738|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779580|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779581|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779582|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779583|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779584|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779585|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779586|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779587|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779588|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779589|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779590|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779734|NCT01474512|O3|Outcome|Ixe/Q4W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
779591|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779592|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779593|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779594|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779595|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779596|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779597|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779598|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779599|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779600|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779601|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779735|NCT01474512|O2|Outcome|Ixe/Q12W|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56 (Maintenance Period).
779602|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779603|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779604|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779605|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779606|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779607|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779608|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779609|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779610|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779611|NCT01474772|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779612|NCT01474772|O1|Outcome|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779736|NCT01474512|O1|Outcome|Ixe/Placebo|Participants who received ixe (Q2W or Q4W) in Induction Period who were re-randomized at Week 12 and administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56 (Maintenance Period).
779613|NCT01474772|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779614|NCT01474772|E1|Reported Event|Pregabalin|The below table included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (2 weeks dose titration and 4 weeks fixed dose for each treatment period). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
779615|NCT01474681|B3|Baseline|Total|Total of all reporting groups
779616|NCT01474681|B2|Baseline|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
779617|NCT01474681|B1|Baseline|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
779618|NCT01474681|P4|Participant Flow|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779619|NCT01474681|P3|Participant Flow|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779620|NCT01474681|P2|Participant Flow|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779621|NCT01474681|P1|Participant Flow|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779622|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779623|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779624|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779625|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779626|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779627|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779628|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779629|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779630|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779631|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779632|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779633|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779634|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779635|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779636|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779637|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779638|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779639|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779640|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779641|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779642|NCT01474681|O2|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779643|NCT01474681|O1|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779644|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779645|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779646|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779647|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779648|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779649|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779650|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779651|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779652|NCT01474681|O4|Outcome|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779653|NCT01474681|O3|Outcome|DUCBT < 18 Yrs|Double umbilical cord blood transplant (DUCBT) less than 18 yrs
779654|NCT01474681|O2|Outcome|SUCBT >= 18 Yrs|Single umbilical cord blood transplant (SUCBT) greater than or equal to 18 yrs
779655|NCT01474681|O1|Outcome|SUCBT < 18 Yrs|Single umbilical cord blood transplant(SUCBT) less than 18 yrs
779656|NCT01474681|E6|Reported Event|DUCBT|Double umbilical cord blood transplant (DUCBT) This is the combination of the DUCBT<18 yrs and DUCBT >= 18 yrs
779657|NCT01474681|E5|Reported Event|SUCBT|Single umbilical cord blood transplant (SUCBT) This is the combination of the SUCBT<18 yrs and SUCBT >= 18 yrs
779658|NCT01474681|E4|Reported Event|DUCBT >= 18 Yrs|Double umbilical cord blood transplant (DUCBT) greater than or equal to 18 yrs
779662|NCT01474551|B1|Baseline|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
779743|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
781125|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
779664|NCT01474551|O1|Outcome|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
779665|NCT01474551|E1|Reported Event|Vemurafenib|"This is a single institution phase II trial in stage III or IV melanoma patients with poor ECOG performance status (3 or 4). Patients must have melanoma with a BRAFV600E or BRAFV600K or mutation with measurable disease not curable by surgery.~Vemurafenib: All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long."
779666|NCT01474538|B3|Baseline|Total|Total of all reporting groups
779667|NCT01474538|B2|Baseline|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
779668|NCT01474538|B1|Baseline|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
779669|NCT01474538|P2|Participant Flow|Insulin Aspart / Insulin Lispro|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1, followed by insulin lispro (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
779670|NCT01474538|P1|Participant Flow|Insulin Lispro / Insulin Aspart|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1, followed by insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 2.
779671|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779672|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779673|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779674|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779675|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779676|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779677|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779678|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779679|NCT01474538|O2|Outcome|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779680|NCT01474538|O1|Outcome|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779681|NCT01474538|E2|Reported Event|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779682|NCT01474538|E1|Reported Event|Insulin Lispro|Insulin lispro [100 units/milliliter (U/mL)] administered by continuous subcutaneous insulin infusion (CSII) pump for 16 weeks in Treatment Period 1 or Treatment Period 2.
779683|NCT01474512|B4|Baseline|Total|Total of all reporting groups
779684|NCT01474512|B3|Baseline|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Week 10.
779685|NCT01474512|B2|Baseline|Ixe Q4W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W.
779686|NCT01474512|B1|Baseline|Placebo|Placebo administered as 2 SC injections Q2W up to Week 10.
779687|NCT01474512|P10|Participant Flow|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779688|NCT01474512|P9|Participant Flow|Ixe Q4W Non-Resp/Ixe Q4W- Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779689|NCT01474512|P8|Participant Flow|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779690|NCT01474512|P7|Participant Flow|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
779737|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779691|NCT01474512|P6|Participant Flow|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779692|NCT01474512|P5|Participant Flow|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection every 12 weeks (Q12W) up to and including Week 56.
779744|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
818099|NCT01333397|O5|Outcome|Dysport 50 U|
779693|NCT01474512|P4|Participant Flow|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
779694|NCT01474512|P3|Participant Flow|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W at Weeks 4, 6, 8, and 10.
779695|NCT01474512|P2|Participant Flow|Ixe Q4W - Induction Period|160 milligrams (mg) ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection every 4 weeks (Q4W). Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
779696|NCT01474512|P1|Participant Flow|Placebo- Induction Period|Placebo was administered as 2 subcutaneous (SC) injections every 2 weeks (Q2W) up to Week 10.
779697|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779698|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779699|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779700|NCT01474512|O4|Outcome|Ixe Q12W - Maintenance Period|80 mg ixe administered as 1 SC injection Q12W from Week 12 up to Week 60
779701|NCT01474512|O3|Outcome|Ixe Q4W - Maintenance Period|80 mg ixe administered as 1 SC injection Q4W from Week 12 up to Week 60
779702|NCT01474512|O2|Outcome|Ixe Q4W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779703|NCT01474512|O1|Outcome|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779704|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779705|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779706|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779707|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779708|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779709|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779710|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779711|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779712|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779713|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779714|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779715|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779716|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779717|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779718|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779719|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779720|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779721|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779722|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779723|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779724|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779725|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779726|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779727|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779728|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779729|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779730|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779731|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779732|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
811998|NCT01353976|B2|Baseline|Vehicle Foam|Placebo medication
779739|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779740|NCT01474512|O3|Outcome|Ixe Q2W|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).
779741|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779742|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
818100|NCT01333397|O4|Outcome|Dysport NG 75 U|
779747|NCT01474512|O2|Outcome|Ixe Q4W|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W (Weeks 4 and 8).
779748|NCT01474512|O1|Outcome|Placebo|Placebo was administered as 2 SC injections Q2W (Weeks 2, 4, 6, 8, and 10).
779749|NCT01474512|E11|Reported Event|Ixe Q4W - Maintenance Period Relapse Pop|Participants who relapsed (loss of response, sPGA ≥3 during Maintenance Period) were administered 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779750|NCT01474512|E10|Reported Event|Q2W Non-Resp/Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q2W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779751|NCT01474512|E9|Reported Event|Ixe Q4W Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received 80 mg ixe Q4W in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779752|NCT01474512|E8|Reported Event|Placebo Non-Resp/Ixe Q4W - Maintenance Period Secondary Pop|Participants who received placebo in Induction Period (Weeks 0 to 10) and classified as non-responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779753|NCT01474512|E7|Reported Event|Placebo Resp/Placebo - Maintenance Period Secondary Pop|Participants who received Placebo during the Induction Period (Weeks 0 to 10) and classified as responders and were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
779754|NCT01474512|E6|Reported Event|Ixe/Ixe Q4W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q4W up to and including Week 56.
779755|NCT01474512|E5|Reported Event|Ixe/Ixe Q12W - Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered 80 mg ixe as 1 SC injection at Week 12 followed by 80 mg ixe as 1 SC injection Q12W up to and including Week 56.
779756|NCT01474512|E4|Reported Event|Ixe/Placebo- Maintenance Period Primary Pop|Participants who received 80 mg ixe Q2W or Q4W in Induction Period (Weeks 0 to 10) and classified as responders were administered placebo as 2 SC injections at Week 12 followed by placebo as 1 SC injection Q4W up to and including Week 56.
779757|NCT01474512|E3|Reported Event|Ixe Q2W - Induction Period|160 mg ixe administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q2W up to Weeks 4, 6, 8 and 10.
779758|NCT01474512|E2|Reported Event|Ixe Q4W - Induction Period|160 mg ixe was administered as 2 SC injections at Week 0 followed by 80 mg ixe as 1 SC injection Q4W. Placebo was administered as 1 SC injection at Weeks 2, 6, and 10.
779759|NCT01474512|E1|Reported Event|Placebo - Induction Period|Placebo was administered as 2 SC injections Q2W up to Week 10.
779760|NCT01474434|B5|Baseline|Total|Total of all reporting groups
779761|NCT01474434|B4|Baseline|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
779762|NCT01474434|B3|Baseline|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
779763|NCT01474434|B2|Baseline|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
779764|NCT01474434|B1|Baseline|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
779765|NCT01474434|P4|Participant Flow|Part A, Cohort 2: Placebo Followed by Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
780001|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
779766|NCT01474434|P3|Participant Flow|Part A, Cohort 2: Pradigastat (LCQ908) Followed by Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
779767|NCT01474434|P2|Participant Flow|Part A, Cohort 1: Placebo Followed by Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received Placebo (5-day treatment period) followed by a 30-day washout period followed by pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by 20 mg (2 x 10-mg tablets) daily for two days
779843|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779768|NCT01474434|P1|Participant Flow|Part A, Cohort 1: Pradigastat (LCQ908) Followed by Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All patients who randomized to this sequence received pradigastat 80 mg (4 x 20-mg tablets) loading dose daily for three days followed by pradigastat 20 mg (2 x 10-mg tablets) daily for two days followed by a 30-day washout period in between followed by 5-day placebo treatment
779769|NCT01474434|O2|Outcome|Part B: Placebo|
779770|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
779771|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779772|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
779773|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779774|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779775|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779776|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
779777|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779778|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779779|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779780|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
779781|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779782|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779783|NCT01474434|O4|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779784|NCT01474434|O3|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
779785|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779786|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779787|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779788|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
779789|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779790|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779791|NCT01474434|O2|Outcome|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
780004|NCT01474122|E1|Reported Event|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
779792|NCT01474434|O1|Outcome|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
779793|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779794|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779795|NCT01474434|O2|Outcome|Part B: Placebo|
779796|NCT01474434|O1|Outcome|Part B: Pradigastat (LCQ908)|
779797|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779798|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779799|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779800|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779801|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779802|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779803|NCT01474434|O2|Outcome|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779804|NCT01474434|O1|Outcome|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779805|NCT01474434|E4|Reported Event|Part A, Cohort 2: Placebo|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779806|NCT01474434|E3|Reported Event|Part A, Cohort 2: Pradigastat (LCQ908)|Cohort 2 consisted of patients with stable asymptomatic non-obstructive coronary artery disease or coronary heart disease risk equivalents and mild to moderate hypertriglyceridemia.. All randomized patients who recieved pradigastat in either of 2 treatment period.
779807|NCT01474434|E2|Reported Event|Part A, Cohort 1: Placebo|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received matching placebo in either of 2 treatment period
779808|NCT01474434|E1|Reported Event|Part A, Cohort 1: Pradigastat (LCQ908)|Cohort 1 consisted of patients with evidence of stable symptomatic or obstructive coronary artery disease and mild to moderate hypertriglyceridemia. All randomized patients who received pradigastat in either of 2 treatment period.
779809|NCT01474317|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
779810|NCT01474317|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
779837|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779838|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
780002|NCT01474122|E3|Reported Event|Placebo|Patients received placebo once daily.
779811|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
779842|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
780005|NCT01474109|B4|Baseline|Total|Total of all reporting groups
779812|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
779813|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
779814|NCT01474317|O1|Outcome|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
779815|NCT01474317|E1|Reported Event|Intended Users of the G3 Investigational BG Monitoring System|"Untrained subjects with diabetes use the G3 investigational blood glucose monitoring system. Of 226 subjects enrolled, 224 completed the study.~G3 Investigational Blood Glucose Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback."
779816|NCT01474291|B3|Baseline|Total|Total of all reporting groups
779817|NCT01474291|B2|Baseline|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779818|NCT01474291|B1|Baseline|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779819|NCT01474291|P1|Participant Flow|All Tocilizumab|Tocilizumab (RoActemra/Actemra) administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779820|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779821|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779822|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779823|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779824|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779825|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779826|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779827|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779828|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779829|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779830|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779831|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779832|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779833|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779834|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779835|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779836|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
780003|NCT01474122|E2|Reported Event|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
779839|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779840|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779841|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
780006|NCT01474109|B3|Baseline|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
779844|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779845|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779846|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779847|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779848|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779849|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779850|NCT01474291|O2|Outcome|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779851|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779852|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779853|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779854|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779855|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779856|NCT01474291|O1|Outcome|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779857|NCT01474291|O1|Outcome|All Tocilizumab|Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779858|NCT01474291|E2|Reported Event|Tocilizumab Combination Therapy|Tocilizumab administered in combination with other standard of care therapy according to prescribing information and normal clinical practice.
779859|NCT01474291|E1|Reported Event|Tocilizumab Monotherapy|Tocilizumab administered as monotherapy according to prescribing information and normal clinical practice.
779860|NCT01474239|B3|Baseline|Total|Total of all reporting groups
779861|NCT01474239|B2|Baseline|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779862|NCT01474239|B1|Baseline|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779863|NCT01474239|P2|Participant Flow|Fotemustine|Participants received fotemustine 75 milligrams per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779864|NCT01474239|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779865|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779866|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779867|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779868|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779869|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779870|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779918|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
779871|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779872|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779873|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779874|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779875|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779876|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779877|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779878|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779879|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779880|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779881|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779882|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779883|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779884|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779885|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779886|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779887|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779888|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779889|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779890|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779891|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779892|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779893|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779894|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779980|NCT01474122|B1|Baseline|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
779895|NCT01474239|O2|Outcome|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779896|NCT01474239|O1|Outcome|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779897|NCT01474239|E2|Reported Event|Fotemustine|Participants received fotemustine 75 mg/m^2 via IV infusion on Days 1, 8, and 15 (induction phase), followed by a 35-day drug-free interval, and then fotemustine 100 mg/m^2 every 21 days (maintenance phase) until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779898|NCT01474239|E1|Reported Event|Bevacizumab|Participants received bevacizumab 10 mg/kg via IV infusion every 14 days until disease progression was radiographically documented or the onset of toxicity prevented treatment continuation.
779899|NCT01474213|B3|Baseline|Total|Total of all reporting groups
779900|NCT01474213|B2|Baseline|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779901|NCT01474213|B1|Baseline|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
779902|NCT01474213|P2|Participant Flow|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779903|NCT01474213|P1|Participant Flow|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
779904|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
779905|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779906|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
779907|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779908|NCT01474213|O2|Outcome|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
779909|NCT01474213|O1|Outcome|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site (had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779910|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Three patients in dexmedetomidine group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
779911|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Two patients in remifentanil group exhibited bradycardia(heart rate<50beats per minute) during endoscopy and intubation period.
779912|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
779913|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779914|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
779915|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779916|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
779917|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779981|NCT01474122|P3|Participant Flow|Placebo|Patients received placebo once daily.
779982|NCT01474122|P2|Participant Flow|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
779919|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779920|NCT01474213|O2|Outcome|Dexmedetomidine Continuously Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg-1) infused over10 min followed by a continuous infusion of 0.7 μg kg-1 h-1.
780007|NCT01474109|B2|Baseline|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780008|NCT01474109|B1|Baseline|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
779921|NCT01474213|O1|Outcome|Remifetanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml-1 and the TCI was adjusted by 0.5 ng ml-1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779922|NCT01474213|E2|Reported Event|Remifentanil Target Controlled Infusion|Patients in the remifentanil group received remifentanil via an Orchestra Base Primea (Fresenius Vial) infusion system using a Minto pharmacokinetic model. The initial target was 3.0 ng ml–1 and the TCI was adjusted by 0.5 ng ml–1 after the target concentration at the effect site had equilibrated with the plasma concentration, until the desired level of sedation was reached.
779923|NCT01474213|E1|Reported Event|Dexmedetomidine Infusion for Sedation|Patients in the dexmedetomidine group received a loading dose (1.5 μg kg–1) infused over10 min followed by a continuous infusion of 0.7 μg kg–1 h–1.
779924|NCT01474200|B3|Baseline|Total|Total of all reporting groups
779925|NCT01474200|B2|Baseline|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779926|NCT01474200|B1|Baseline|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779927|NCT01474200|P2|Participant Flow|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779928|NCT01474200|P1|Participant Flow|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779929|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779930|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779931|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779932|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779983|NCT01474122|P1|Participant Flow|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
779984|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
779985|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
779933|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
818101|NCT01333397|O3|Outcome|Dysport NG 50 U|
779934|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779935|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779936|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779937|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779938|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779939|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779940|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779941|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779942|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779943|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779986|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
779987|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
779988|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
779944|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
818102|NCT01333397|O2|Outcome|Dysport NG 20 U|
779945|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779946|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779947|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779948|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779949|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779950|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779951|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779952|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779953|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779954|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779989|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
779990|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
779991|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
811999|NCT01353976|B1|Baseline|Econazole Nitrate Foam 1%|Study medication
780009|NCT01474109|P3|Participant Flow|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
780010|NCT01474109|P2|Participant Flow|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780011|NCT01474109|P1|Participant Flow|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780012|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
818103|NCT01333397|O1|Outcome|Placebo|
779955|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779956|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779957|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779958|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779959|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779960|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779961|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779962|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779963|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779964|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779965|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779992|NCT01474122|O1|Outcome|Macitentan 3mg|Patients received macitentan once daily at a dose of 3 mg.
779993|NCT01474122|O3|Outcome|Placebo|Patients received placebo once daily.
779994|NCT01474122|O2|Outcome|Macitentan 10mg|Patients received macitentan 10mg once daily.
779966|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779967|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779968|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779969|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779970|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779971|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779972|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779973|NCT01474200|O2|Outcome|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779974|NCT01474200|O1|Outcome|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779975|NCT01474200|E2|Reported Event|IV Loop Diuretics (LD)|Excess fluid from the patient was removed by IV (Intravenous) loop diuretic treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. This included furosemide or other IV loop diuretics administered at equivalent doses to furosemide. The recommended doses of IV bolus, maintenance dose and potential additional diuretics were outlined in treatment guidelines and were based on the CARRESS-HF Stepped Pharmacologic Protocol.
779976|NCT01474200|E1|Reported Event|Aquapheresis (AQ) - Isolated Veno-venous Ultrafiltration|Excess fluid from the patient was removed by isolated veno-venous ultrafiltration treatment using the FDA cleared Aquadex Flex Flow System during index hospitalization until the patient's signs and symptoms of fluid overload improved to the satisfaction of the treating physician. Diuretics were withheld for the duration of the AQ treatment and the use of positive inotropic agents and vasodilators were prohibited unless deemed necessary by the treating physician as rescue therapy. Ultrafiltration rates and monitoring of treatment were outlined in treatment guidelines.
779977|NCT01474122|B4|Baseline|Total|Total of all reporting groups
779978|NCT01474122|B3|Baseline|Placebo|Patients received placebo once daily.
779979|NCT01474122|B2|Baseline|Macitentan 10mg|Patients received macitentan once daily at a dose of 10 mg.
812000|NCT01353976|P2|Participant Flow|Vehicle Foam|Placebo medication
780013|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780014|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780015|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
780016|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780017|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780018|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
780019|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780020|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780021|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
780022|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780023|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780024|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
780025|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780026|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780027|NCT01474109|O3|Outcome|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
780028|NCT01474109|O2|Outcome|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780029|NCT01474109|O1|Outcome|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780030|NCT01474109|E3|Reported Event|Placebo|"matching placebo once daily~placebo: matching placebo once daily"
780031|NCT01474109|E2|Reported Event|Macitentan 10mg|"macitentan 10mg tablet once daily~macitentan 10mg: macitentan 10mg tablet once daily"
780032|NCT01474109|E1|Reported Event|Macitentan 3mg|"macitentan 3mg tablet once daily~macitentan 3mg: macitentan 3mg tablet once daily"
780033|NCT01473992|B3|Baseline|Total|Total of all reporting groups
780034|NCT01473992|B2|Baseline|Non Amputee Control Group|non-amputee healty controls
780035|NCT01473992|B1|Baseline|Entire Study Population|Includes groups randomized to receive Otto Bock C-Leg (prosthetic knee 1), amputees' preferred prosthetic knee, first and Otto Bock Genium (prosthetic knee 2), the study knee, first.
780036|NCT01473992|P3|Participant Flow|Control (Non-amputees)|Non-amputee control group
780037|NCT01473992|P2|Participant Flow|Prosthetic Knee 2 Then Prosthetic Knee 1|Experimental knee (Otto Bock Genium: Study knee) then subjects' preferred knee (C-Leg).
780038|NCT01473992|P1|Participant Flow|Prosthetic Knee 1 Then Prosthetic Knee 2|Otto Bock C-Leg: Amputees' preferred prosthetic knee then experimental knee (Genium).
780039|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee control group
780040|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
780041|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
780042|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
780043|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
780044|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
780045|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
780046|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
780047|NCT01473992|O3|Outcome|Non Amputee Control Group|healthy, non-amputee controls
780048|NCT01473992|O2|Outcome|Prosthetic Knee 2|Otto Bock Genium: Study knee.
780049|NCT01473992|O1|Outcome|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
780050|NCT01473992|E2|Reported Event|Prosthetic Knee 2|Otto Bock Genium: Study knee.
780051|NCT01473992|E1|Reported Event|Prosthetic Knee 1|Otto Bock C-Leg: Amputees' preferred prosthetic knee.
780052|NCT01473953|B6|Baseline|Total|Total of all reporting groups
780053|NCT01473953|B5|Baseline|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780054|NCT01473953|B4|Baseline|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780055|NCT01473953|B3|Baseline|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780056|NCT01473953|B2|Baseline|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780057|NCT01473953|B1|Baseline|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780058|NCT01473953|P5|Participant Flow|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780840|NCT01470651|B1|Baseline|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
780059|NCT01473953|P4|Participant Flow|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780060|NCT01473953|P3|Participant Flow|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780061|NCT01473953|P2|Participant Flow|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780062|NCT01473953|P1|Participant Flow|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780063|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780064|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780065|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780066|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780067|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780068|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780069|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780070|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780071|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780072|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780073|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780074|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780075|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780076|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780077|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780078|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780079|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780080|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780081|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780082|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780083|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780084|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780085|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780086|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780087|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780088|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780089|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780090|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780091|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780092|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780093|NCT01473953|O5|Outcome|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780094|NCT01473953|O4|Outcome|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780095|NCT01473953|O3|Outcome|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780096|NCT01473953|O2|Outcome|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780097|NCT01473953|O1|Outcome|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780098|NCT01473953|E5|Reported Event|Placebo|In the placebo group a corresponding volume of liraglutide-depot placebo was administered subcutaneous (s.c.).
780099|NCT01473953|E4|Reported Event|Cohort 4a: Lira-depot 30 mg|In cohort 4a a single subcutaneous dose of 30 mg liraglutide-depot was administered.
780100|NCT01473953|E3|Reported Event|Cohort 3a: Lira-depot 15 mg|In cohort 3a a single subcutaneous dose of 15 mg liraglutide-depot was administered.
780101|NCT01473953|E2|Reported Event|Cohort 2a: Lira-depot 6.75 mg|In cohort 2a a single subcutaneous dose of 6.75 mg liraglutide-depot was administered.
780102|NCT01473953|E1|Reported Event|Cohort 1a: Lira-depot 2.25 mg|In cohort 1a a single subcutaneous dose of 2.25 mg liraglutide-depot was administered.
780127|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780306|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780103|NCT01473836|B1|Baseline|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780104|NCT01473836|P1|Participant Flow|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780132|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780105|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780106|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780107|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780108|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780109|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780110|NCT01473836|O1|Outcome|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780111|NCT01473836|E1|Reported Event|Metronidazole/Ceftriaxone|Metronidazole was administered in combination with ceftriaxone sodium, at a dose of 500 mg three times a day (TID) or four times a day (QID) for refractory or severe infection. Ceftriaxone was administered at the dose of 1 g twice a day (BID) when metronidazole was administered TID, or at dose of 2 g BID when metronidazole was administered QID. The duration of drug administration was 3 to 14 days.
780112|NCT01473758|B3|Baseline|Total|Total of all reporting groups
780113|NCT01473758|B2|Baseline|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780114|NCT01473758|B1|Baseline|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780115|NCT01473758|P4|Participant Flow|Placebo (Cycle 2)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
780116|NCT01473758|P3|Participant Flow|Roflumilast 500 µg (Cycle 2)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations in Cycle 2.
780117|NCT01473758|P2|Participant Flow|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
780118|NCT01473758|P1|Participant Flow|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations. Eligible participants were re-randomized to receive either roflumilast 500 μg or placebo for 4 weeks in Cycle 2.
780119|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780120|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780121|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780122|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780123|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780124|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780125|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780126|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
781114|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
780128|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780129|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780130|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780131|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
818104|NCT01333397|O5|Outcome|Dysport 50 U|
780133|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780134|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780135|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780136|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780137|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780138|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780139|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780140|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780141|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780142|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780143|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780144|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780145|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780146|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780147|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780148|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780149|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780150|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780151|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780152|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780153|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780154|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780155|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780156|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780157|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780158|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780159|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780160|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780161|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780162|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
781115|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
780163|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780164|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780165|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780166|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780167|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780168|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780169|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780170|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780171|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780172|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780173|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780174|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780175|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780176|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780177|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780178|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780179|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780180|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780181|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780182|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780183|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780184|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780185|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780186|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780187|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780188|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780189|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780190|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780191|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780192|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780193|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780194|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780195|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780196|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780197|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
781116|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
780198|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780199|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780200|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780201|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780202|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780203|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780204|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780205|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780206|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780207|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780208|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780209|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780210|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780211|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780212|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780213|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780214|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780215|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780216|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780217|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780218|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780219|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780220|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780221|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780222|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780223|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780224|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780225|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780226|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780227|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780228|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780229|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780230|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780231|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780232|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
781117|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
780233|NCT01473758|O2|Outcome|Placebo|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780234|NCT01473758|O1|Outcome|Roflumilast 500 μg|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast for 4 weeks added on to standard therapy for acute COPD exacerbations.
780235|NCT01473758|E4|Reported Event|Placebo (Extended Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
780268|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
781126|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
780236|NCT01473758|E3|Reported Event|Roflumilast 500 µg (Extended Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Extended Approach Arm includes all participants who received treatment in Cycle 1 and those participants who were re-randomized and received treatment in Cycle 2.
780237|NCT01473758|E2|Reported Event|Placebo (Initial Approach)|Placebo matching roflumilast tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
780238|NCT01473758|E1|Reported Event|Roflumilast 500 μg (Initial Approach)|Roflumilast 500 µg tablet, once daily, orally in the morning after breakfast added on to standard therapy for acute COPD exacerbations. Initial Approach Arm includes all participants who received treatment in Cycle 1.
780239|NCT01473745|B3|Baseline|Total|Total of all reporting groups
780240|NCT01473745|B2|Baseline|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780241|NCT01473745|B1|Baseline|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780242|NCT01473745|P2|Participant Flow|Modified Alar Cinch Group|Patients received modified alar base cinch technique during LeFort I osteotomy procedure.
780243|NCT01473745|P1|Participant Flow|Conventional Alar Cinch Group|Patients received conventional alar base cinch technique during LeFort I osteotomy procedure.
780244|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780245|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780246|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780247|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780248|NCT01473745|O2|Outcome|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780249|NCT01473745|O1|Outcome|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from intraoral to extraoral and from one side to another side~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780250|NCT01473745|E2|Reported Event|Conventional Alar Base Cinch Suture|"conventional nasal cinch alar base technique: suture goes through bilateral alar base and anterior nasal spine(ANS) and nasalis muscle intra-orally~conventional nasal alar cinch suture technique: conventional alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780251|NCT01473745|E1|Reported Event|Modified Alar Cinch Suture|"modified extraoral alar cinch suture techniques suture from not only ANS and nasalis muscle, but also through the dermis layer of the alar base.~modified extraoral alar base cinch technique: modified alar cinch suture technique performed after the maxillary Lefort I osteotomy."
780252|NCT01473602|B3|Baseline|Total|Total of all reporting groups
780253|NCT01473602|B2|Baseline|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780254|NCT01473602|B1|Baseline|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780255|NCT01473602|P2|Participant Flow|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780256|NCT01473602|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780257|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780258|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780259|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780260|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780261|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780262|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780263|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780264|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780265|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780266|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780267|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780381|NCT01473394|B3|Baseline|Total|Total of all reporting groups
780269|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780270|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780271|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780272|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780273|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780274|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780275|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780276|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780277|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780278|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780279|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780280|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780281|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780282|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780283|NCT01473602|O2|Outcome|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780284|NCT01473602|O1|Outcome|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780285|NCT01473602|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780286|NCT01473602|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780287|NCT01473602|E2|Reported Event|Teriparatide|Teriparatide 20 µg once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780288|NCT01473602|E1|Reported Event|Placebo|Placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780289|NCT01473589|B3|Baseline|Total|Total of all reporting groups
780290|NCT01473589|B2|Baseline|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780291|NCT01473589|B1|Baseline|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780292|NCT01473589|P2|Participant Flow|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780293|NCT01473589|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (µg) administered once-daily by subcutaneous (SC) injection for 6 months. Participants received calcium and vitamin D supplements.
780294|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780295|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780296|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780297|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780298|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780299|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780300|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780301|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780302|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780303|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780304|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780305|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780307|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780308|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780309|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780310|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780311|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780312|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780313|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780314|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780315|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780316|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780317|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780318|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780319|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780320|NCT01473589|O2|Outcome|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780321|NCT01473589|O1|Outcome|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780322|NCT01473589|E4|Reported Event|Teriparatide Follow-up|Follow-up after teriparatide 20 µg once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780323|NCT01473589|E3|Reported Event|Placebo Follow-up|Follow-up after placebo once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780324|NCT01473589|E2|Reported Event|Teriparatide|Teriparatide 20 µg administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780325|NCT01473589|E1|Reported Event|Placebo|Placebo administered once-daily by SC injection for 6 months. Participants received calcium and vitamin D supplements.
780326|NCT01473563|B1|Baseline|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780327|NCT01473563|P1|Participant Flow|Pemetrexed|Pemetrexed: 500 milligrams per meter squared (mg/m^2) administered as an intravenous (IV) infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780328|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780329|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780330|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780331|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780332|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780333|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780334|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780335|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
813067|NCT01350128|E6|Reported Event|Placebo BID|Placebo BID.
780336|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780337|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780842|NCT01470651|P1|Participant Flow|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
780338|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780339|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780340|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780341|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780342|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780343|NCT01473563|O1|Outcome|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780344|NCT01473563|E1|Reported Event|Pemetrexed|Pemetrexed: 500 mg/m^2 IV infusion over approximately 10 minutes on Day 1 of each 21-day cycle until disease progression or the participant discontinued for any other reason. The first dose of maintenance therapy was administered at the hospital; thereafter, therapy was administered in the home setting by qualified oncology homecare nurses.
780345|NCT01473524|B4|Baseline|Total|Total of all reporting groups
780346|NCT01473524|B3|Baseline|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780347|NCT01473524|B2|Baseline|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780348|NCT01473524|B1|Baseline|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780349|NCT01473524|P3|Participant Flow|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780350|NCT01473524|P2|Participant Flow|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780351|NCT01473524|P1|Participant Flow|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780352|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780353|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780354|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780355|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780356|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780469|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
813409|NCT01349114|B3|Baseline|Total|Total of all reporting groups
780357|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780358|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
818105|NCT01333397|O4|Outcome|Dysport NG 75 U|
780359|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780360|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780361|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780362|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780363|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780364|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780365|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780366|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780367|NCT01473524|O3|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780368|NCT01473524|O2|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780369|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780370|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780371|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780372|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780373|NCT01473524|O1|Outcome|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period.~After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780374|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780375|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780376|NCT01473524|O2|Outcome|Placebo|One tablet daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780377|NCT01473524|O1|Outcome|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780378|NCT01473524|E3|Reported Event|Placebo|One tablet daily for double-blind period. After completion of the 1 year double-blind period period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
813410|NCT01349114|B2|Baseline|Placebo|Sugar pill/placebo
780379|NCT01473524|E2|Reported Event|OCA 10 mg|OCA 10 mg for double-blind period. After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated.
780380|NCT01473524|E1|Reported Event|OCA 5-10 mg|"OCA 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double blind-period.~After completion of the 1 year double-blind period subjects will be offered the opportunity to enter an open label long term safety extension for up to 5 years beginning at 5 mg OCA. Doses up to 25 mg daily will be evaluated."
780382|NCT01473394|B2|Baseline|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
780383|NCT01473394|B1|Baseline|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
780384|NCT01473394|P2|Participant Flow|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
780385|NCT01473394|P1|Participant Flow|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
780386|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
780387|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
780388|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
780389|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
780390|NCT01473394|O2|Outcome|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
780391|NCT01473394|O1|Outcome|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
780392|NCT01473394|E2|Reported Event|Vilazodone|Participants received vilazodone orally once daily for 9 weeks, as follows: Week 1, 10 mg once a day; Week 2, 20 mg once a day; Weeks 3 to 8, 40 mg once a day; and Week 9 (down-taper period), 20 mg once a day for 4 days, then 10 mg once a day for 3 days.
780393|NCT01473394|E1|Reported Event|Dose-matched Placebo|Participants received dose-matched placebo orally once daily for 9 weeks.
780394|NCT01473381|B5|Baseline|Total|Total of all reporting groups
780395|NCT01473381|B4|Baseline|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
780396|NCT01473381|B3|Baseline|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
780397|NCT01473381|B2|Baseline|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
780398|NCT01473381|B1|Baseline|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
780399|NCT01473381|P4|Participant Flow|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
780400|NCT01473381|P3|Participant Flow|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
780401|NCT01473381|P2|Participant Flow|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
780402|NCT01473381|P1|Participant Flow|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
780403|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
780404|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days
813411|NCT01349114|B1|Baseline|Aliskiren|aliskiren 300 mg daily
780405|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
780406|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
780473|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
818106|NCT01333397|O3|Outcome|Dysport NG 50 U|
780407|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
780408|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
780409|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
780410|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
780411|NCT01473381|O4|Outcome|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
780412|NCT01473381|O3|Outcome|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
780413|NCT01473381|O2|Outcome|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
780414|NCT01473381|O1|Outcome|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
780415|NCT01473381|E4|Reported Event|Citalopram 40 mg/Day|Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
780416|NCT01473381|E3|Reported Event|Vilazodone 40 mg/Day|Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days.
780417|NCT01473381|E2|Reported Event|Vilazodone 20 mg/Day|Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11.
780418|NCT01473381|E1|Reported Event|Placebo|Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study.
780419|NCT01473368|B5|Baseline|Total|Total of all reporting groups
780420|NCT01473368|B4|Baseline|Control|control group
780421|NCT01473368|B3|Baseline|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
780422|NCT01473368|B2|Baseline|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
780423|NCT01473368|B1|Baseline|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
780424|NCT01473368|P4|Participant Flow|Control|Control group
780425|NCT01473368|P3|Participant Flow|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
780426|NCT01473368|P2|Participant Flow|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
780427|NCT01473368|P1|Participant Flow|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
780428|NCT01473368|O7|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
780429|NCT01473368|O6|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During Treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
780430|NCT01473368|O5|Outcome|Core Microbiome|Core Microbiome
780431|NCT01473368|O4|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
780432|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During Treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
780470|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
780433|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
780474|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
780434|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During Treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
780435|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic) After Treatment|"After treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
780436|NCT01473368|O2|Outcome|Combination (Prebiotic and Antibiotic) During Treatment|"During treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
780437|NCT01473368|O1|Outcome|Combination (Prebiotic and Antibiotic) Before Treatment|"Before treatment~Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily)."
780438|NCT01473368|O3|Outcome|Antibiotic (Amoxicillin Clavulanate) After Treatment|"After treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
780439|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate) During Treatment|"During treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
780440|NCT01473368|O1|Outcome|Antibiotic (Amoxicillin Clavulanate) Before Treatment|"Before treatment~Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days"
780441|NCT01473368|O3|Outcome|Prebiotic (Saccharomyces Boulardii) After Treatment|"After treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
780442|NCT01473368|O2|Outcome|Prebiotic (Saccharomyces Boulardii) During Treatment|"During treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
780443|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii) Before Treatment|"Before treatment~Saccharomyces boulardii: 500 mg, 2 times daily for 14 days"
780444|NCT01473368|O4|Outcome|Control|Control group
780445|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
780446|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
780447|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
780448|NCT01473368|O4|Outcome|Control|Control group
780449|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
780450|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
780451|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
780452|NCT01473368|O4|Outcome|Control|Control group
780453|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
780454|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
780455|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
780456|NCT01473368|O3|Outcome|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
780457|NCT01473368|O2|Outcome|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
780458|NCT01473368|O1|Outcome|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
780459|NCT01473368|E4|Reported Event|Control|
780460|NCT01473368|E3|Reported Event|Combination (Prebiotic and Antibiotic)|Saccharomyces boulardii AND Amoxicillin Clavulanate: Amoxicillin Clavulanate for 7 days (days 1 to 7; 875/125 mg 2 times daily at least 1 hour before meals) in addition to the dietary supplement Saccharomyces boulardii for 14 days (days 1 to 14; 500 mg, 2 times daily).
780461|NCT01473368|E2|Reported Event|Antibiotic (Amoxicillin Clavulanate)|Amoxicillin Clavulanate: 875/125 mg 2 times daily at least 1 hour before meals for 7 days
780462|NCT01473368|E1|Reported Event|Prebiotic (Saccharomyces Boulardii)|Saccharomyces boulardii: 500 mg, 2 times daily for 14 days
780463|NCT01473160|B1|Baseline|Overall Study|All enrolled participants
780464|NCT01473160|P1|Participant Flow|Overall Study|All enrolled participants
780465|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
780466|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
780467|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
780468|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
780471|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
780472|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
781127|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
780475|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
780476|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
780477|NCT01473160|O2|Outcome|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
780478|NCT01473160|O1|Outcome|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
780479|NCT01473160|E2|Reported Event|Narafilcon A|Narafilcon A contact lens in one eye, with delefilcon A in the fellow eye, worn one day, 16 hours
780480|NCT01473160|E1|Reported Event|Delefilcon A|Delefilcon A contact lens in one eye, with narafilcon A in the fellow eye, worn one day, 16 hours
780481|NCT01472939|B5|Baseline|Total|Total of all reporting groups
780482|NCT01472939|B4|Baseline|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780483|NCT01472939|B3|Baseline|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780484|NCT01472939|B2|Baseline|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780485|NCT01472939|B1|Baseline|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
780486|NCT01472939|P4|Participant Flow|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780487|NCT01472939|P3|Participant Flow|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780488|NCT01472939|P2|Participant Flow|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780489|NCT01472939|P1|Participant Flow|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
780490|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780491|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780492|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780493|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780494|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780495|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780496|NCT01472939|O3|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780497|NCT01472939|O2|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780498|NCT01472939|O1|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780499|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780500|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780501|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780502|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
780503|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780504|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780505|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780506|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
780507|NCT01472939|O4|Outcome|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780508|NCT01472939|O3|Outcome|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780509|NCT01472939|O2|Outcome|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780510|NCT01472939|O1|Outcome|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
780511|NCT01472939|E4|Reported Event|SSP-002358 2.0mg + PPI|2.0 mg tablet taken TID in addition to a PPI
780512|NCT01472939|E3|Reported Event|SSP-002358 0.5mg + PPI|0.5 mg tablet taken TID in addition to a PPI
780513|NCT01472939|E2|Reported Event|SSP-002358 0.1mg + PPI|0.1 mg tablet taken TID in addition to a PPI
780514|NCT01472939|E1|Reported Event|Placebo + PPI|Placebo taken three times daily (TID) in addition to a PPI
780515|NCT01472874|B1|Baseline|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780516|NCT01472874|P1|Participant Flow|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780517|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780518|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780519|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780779|NCT01471197|P1|Participant Flow|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
780520|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780521|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780522|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780523|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780524|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780525|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780526|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780527|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780528|NCT01472874|O1|Outcome|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780529|NCT01472874|E1|Reported Event|Once a Day Trientine|"Patients receive once a day trientine~Once a day Trientine: Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year."
780530|NCT01472835|B3|Baseline|Total|Total of all reporting groups
780531|NCT01472835|B2|Baseline|Control|Patient will not receive no sedation during their 1st procedure and sedation during their 2nd procedure
780532|NCT01472835|B1|Baseline|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780533|NCT01472835|P2|Participant Flow|Control|Patient will not receive sedation during their 1st procedure, but receive sedation during the 2nd procedure
780534|NCT01472835|P1|Participant Flow|Sedation|"Pt will receive sedation with their 1st procedure, then a control procedure will be done without sedation~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780535|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
780536|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780537|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
780538|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780539|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during the 1st procedure, but receive sedation during their 2nd procedure
780540|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780541|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during procedure
780542|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780543|NCT01472835|O2|Outcome|Control|Patient will not receive sedation during their 1st procedure but receive sedation during their 2nd procedure
780544|NCT01472835|O1|Outcome|Sedation|"Pt will receive sedation with their 1st procedure and no sedation with their 2nd procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780545|NCT01472835|E2|Reported Event|Control|Patient did not receive sedation during procedure
813516|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
780546|NCT01472835|E1|Reported Event|Sedation|"Pt received sedation with their procedure~sacroiliac joint injection: Patient will receive an injection into the sacroiliac joint with bupivacaine and corticosteroid with and without sedation. Since this is a crossover trial, patients will receive both treatments.~Sympathetic block: Sympathetic block with bupivacaine~bupivacaine~corticosteroid"
780547|NCT01472822|B3|Baseline|Total|Total of all reporting groups
780548|NCT01472822|B2|Baseline|Placebo|
780549|NCT01472822|B1|Baseline|Omija|
780550|NCT01472822|P2|Participant Flow|Placebo|"Placebo(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Omija extract.."
780551|NCT01472822|P1|Participant Flow|Omija Extract.|"Omija extract.(2times/day, 4tablets/day, 1.2g/day) for 12weeks~Omija extract.: Omija extracted with ethanol and then concentrated and dried."
780552|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
780553|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
780554|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
780555|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
780556|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
780557|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
780558|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
780559|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
780560|NCT01472822|O2|Outcome|Placebo|Oral intake placebo(1.2g/day) for 12weeks
780561|NCT01472822|O1|Outcome|Omija Extract|Oral intake Omija extract(1.2g/day) for 12weeks.
780562|NCT01472822|E2|Reported Event|Placebo|
780563|NCT01472822|E1|Reported Event|Omija|
780564|NCT01472562|B1|Baseline|All Patients|Study Treatment Arm
780565|NCT01472562|P1|Participant Flow|All Patients|Study Treatment Arm
780566|NCT01472562|O1|Outcome|All Patients|Study Treatment Arm
780567|NCT01472562|O1|Outcome|All Patients|Study Treatment Arm
780568|NCT01472562|E1|Reported Event|All Patients|Study Treatment Arm
780569|NCT01472432|B3|Baseline|Total|Total of all reporting groups
780570|NCT01472432|B2|Baseline|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780571|NCT01472432|B1|Baseline|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780572|NCT01472432|P2|Participant Flow|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780573|NCT01472432|P1|Participant Flow|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780574|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780575|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780576|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea"
780588|NCT01472380|B1|Baseline|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
781118|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
780589|NCT01472380|P1|Participant Flow|Efavirenz Alone, FFA Alone, Enfavirenz and FFA Together|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours
818107|NCT01333397|O2|Outcome|Dysport NG 20 U|
780577|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~Placebo: Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea"
780578|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780579|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780580|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780581|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780582|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780583|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780584|NCT01472432|O2|Outcome|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780585|NCT01472432|O1|Outcome|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780586|NCT01472432|E2|Reported Event|Vildagliptin|"The experimental arm followed the same treatment of placebo group, but received also vildagliptin 50 mg per os b.i.d. for 4 months~vildagliptin: 50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice."
780587|NCT01472432|E1|Reported Event|Placebo|"In the placebo group, the dose of other concomitant hypoglycemic medication was changed to obtain a similar profile of metabolic parameters. Additional antidiabetic therapy, including sulfonylurea, metformin, and insulin, was titrated for optimal glycemic control for 3 months. All patients had diabetes and at least one full-thickness wound below the ankle for >3 months. All patients were examined weekly for the first 4 weeks (day 28) then every other week until day 120 or ulcer closure by any means. At each visit, tracings of the wound margins were made for computer planimetry to document changes in wound size, and photographs were taken for a visual record. All patients followed the regular treatment at the multidisciplinary diabetes foot clinic, included treatment of infection, debridement, off-loading, and metabolic control according to high international standards and standard good medical practice.~placebo: Placebo is added to the standard good medical practice."
780617|NCT01472185|B1|Baseline|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780590|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
780591|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
780592|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
780593|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
780594|NCT01472380|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
780595|NCT01472380|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period
780596|NCT01472380|E3|Reported Event|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
780597|NCT01472380|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
780598|NCT01472380|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
780599|NCT01472341|B1|Baseline|All Participants|Participants receiving routine care under a diabetologist.
780600|NCT01472341|P1|Participant Flow|All Participants|Participants receiving routine care under a diabetologist.
780601|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
780602|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
780603|NCT01472341|O1|Outcome|All Participants|Participants receiving routine care under a diabetologist.
780604|NCT01472341|E1|Reported Event|All Participants|Participants receiving routine care under a diabetologist.
780605|NCT01472289|B1|Baseline|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780606|NCT01472289|P1|Participant Flow|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells (BMMNCs) concentrate prepared using the Res-Q 60 technology (a point of care system) and injected the concentrate intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780607|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780608|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780609|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780610|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780611|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780612|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780613|NCT01472289|O1|Outcome|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic tissue of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780614|NCT01472289|E1|Reported Event|BMMNC Treated Group|All the subjects enrolled in the study were treated using autologous Bone Marrow Mononuclear Cells concentrate (BMMNCs) prepared using the Res-Q 60 technology (a point of care system) and injected intra-muscularly into multiple sites in the ischemic muscle of the affected limb at 0.5 cc/injection for a total of 15-20 cc.
780615|NCT01472185|B3|Baseline|Total|Total of all reporting groups
780616|NCT01472185|B2|Baseline|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
813517|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
780618|NCT01472185|P2|Participant Flow|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780784|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
780619|NCT01472185|P1|Participant Flow|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780620|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780621|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780622|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780623|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780624|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780625|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780626|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780627|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780628|NCT01472185|O2|Outcome|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780629|NCT01472185|O1|Outcome|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780630|NCT01472185|E2|Reported Event|Ranolazine|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Ranolazine tablets (Days 1–7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780631|NCT01472185|E1|Reported Event|Placebo|"Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.~Treatment Period: Placebo to match ranolazine (Days 1–7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.~Participants were required to maintain their diet and exercise regimen."
780632|NCT01471782|B7|Baseline|Total|Total of all reporting groups
780633|NCT01471782|B6|Baseline|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780634|NCT01471782|B5|Baseline|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780635|NCT01471782|B4|Baseline|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780636|NCT01471782|B3|Baseline|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780637|NCT01471782|B2|Baseline|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780638|NCT01471782|B1|Baseline|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780639|NCT01471782|P6|Participant Flow|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780780|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
780640|NCT01471782|P5|Participant Flow|Phase 1: Blinatumomab 5/15 µg/m²/Day|PK Expansion: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780641|NCT01471782|P4|Participant Flow|Phase 1: Blinatumomab 15/30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780642|NCT01471782|P3|Participant Flow|Phase 1: Blinatumomab 30 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780643|NCT01471782|P2|Participant Flow|Phase 1: Blinatumomab 15 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780644|NCT01471782|P1|Participant Flow|Phase 1: Blinatumomab 5 µg/m²/Day|Dose Evaluation/Escalation: Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780645|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
780646|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
780647|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day..
780648|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780649|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780650|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780651|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780652|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780653|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780654|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780655|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780656|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780657|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780658|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780659|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780660|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780661|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780781|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
780662|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780663|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780664|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780665|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780666|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780667|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780668|NCT01471782|O2|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780669|NCT01471782|O1|Outcome|Phase 1: Blinatumomab|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate ranging from 5 to 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780670|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day.
780671|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day.
780672|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day.
780673|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780674|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780675|NCT01471782|O3|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780676|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780677|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780678|NCT01471782|O7|Outcome|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/ day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780679|NCT01471782|O6|Outcome|Phase 2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780680|NCT01471782|O5|Outcome|Phase 1: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780681|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780682|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780683|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780782|NCT01471197|O2|Outcome|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
813518|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
780684|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
781991|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
780685|NCT01471782|O4|Outcome|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780686|NCT01471782|O3|Outcome|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780687|NCT01471782|O2|Outcome|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780688|NCT01471782|O1|Outcome|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous (cIV) infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780689|NCT01471782|E6|Reported Event|Total|All Participants who received blinatumomab administered as a continuous intravenous infusion at a constant daily flow rate.
780690|NCT01471782|E5|Reported Event|Phase 1: Blinatumomab 30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 30 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780691|NCT01471782|E4|Reported Event|Phase 1: Blinatumomab 15/30 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day for the first week of cycle 1 and then at 30 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 30 µg/m²/day for up to five cycles of treatment.
780692|NCT01471782|E3|Reported Event|Phase 1+2: Blinatumomab 5/15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day for the first week of cycle 1 and then at 15 µg/m²/day for 3 weeks followed by a treatment-free interval of 2 weeks. Participants received subsequent cycles at 15 µg/m²/day for up to five cycles of treatment.
780693|NCT01471782|E2|Reported Event|Phase 1: Blinatumomab 15 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 15 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780694|NCT01471782|E1|Reported Event|Phase 1: Blinatumomab 5 µg/m²/Day|Blinatumomab was administered as a continuous intravenous infusion at a constant daily flow rate of 5 µg/m²/day over 4 weeks followed by a treatment-free interval of 2 weeks for up to five cycles of treatment.
780695|NCT01471691|B3|Baseline|Total|Total of all reporting groups
780696|NCT01471691|B2|Baseline|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
780697|NCT01471691|B1|Baseline|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
780698|NCT01471691|P2|Participant Flow|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose Patients were given six months of monthly treatment with the 1.0mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
780699|NCT01471691|P1|Participant Flow|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose Patients were given six months of monthly treatment with the standard 0.5mg ranibizumab dose, followed by six months of evaluation and PRN treatment based upon pre-specified criteria.
780700|NCT01471691|O2|Outcome|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
780701|NCT01471691|O1|Outcome|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
780702|NCT01471691|E2|Reported Event|Intravitreal Ranibizumab 1.0mg|ranibizumab 1.0mg: High dose
780703|NCT01471691|E1|Reported Event|Intravitreal Ranibizumab 0.5mg|ranibizumab 0.5mg: Standard dose
780704|NCT01471626|B1|Baseline|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
780705|NCT01471626|P1|Participant Flow|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
780706|NCT01471626|O1|Outcome|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
780707|NCT01471626|E1|Reported Event|Telematic Attended Polysomnography|"All patients underwent one Home-PSG, using Dream and Sleepbox (Medatec, Belgium), that is a wireless system able to communicate with Dream, and with Internet through a wi-fi/3G interface. It is equipped with a digital infrared camera, and with a speaker/microphone system for bidirectional audio/video communication via Skype.~The Sleep Lab nurse performed a discontinue monitoring of the PSG. In case of defective signals, she called the patient who had been previously educated to replace the sensors."
780708|NCT01471574|B5|Baseline|Total|Total of all reporting groups
780753|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
781119|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
780754|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780709|NCT01471574|B4|Baseline|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780710|NCT01471574|B3|Baseline|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780711|NCT01471574|B2|Baseline|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780712|NCT01471574|B1|Baseline|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780713|NCT01471574|P4|Participant Flow|Non-­HAART Therapy|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780714|NCT01471574|P3|Participant Flow|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780715|NCT01471574|P2|Participant Flow|HAART: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780716|NCT01471574|P1|Participant Flow|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780717|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780718|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780719|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780720|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780721|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
781120|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
780722|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780723|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30, 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780724|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780725|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780726|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780727|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780728|NCT01471574|O3|Outcome|HAART Therapy: Daclatasvir, 30mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg),, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780729|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780730|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780731|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780732|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780733|NCT01471574|O2|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780734|NCT01471574|O1|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780839|NCT01470651|B2|Baseline|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
780735|NCT01471574|O5|Outcome|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780736|NCT01471574|O4|Outcome|HAART Therapy: Daclatasvir 30 or 60 or 90 mg|Participants with prior exposure to HAART therapy, received daclatasvir tablets , either 30, 60 or 90 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for Participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780737|NCT01471574|O3|Outcome|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received daclatasvir tablets, 90 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780738|NCT01471574|O2|Outcome|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780739|NCT01471574|O1|Outcome|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780740|NCT01471574|E4|Reported Event|Non-HAART Therapy: Daclatasvir, 60 mg|Participants not receiving HAART received daclatasvir tablets, 60 mg, orally, once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally, twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780741|NCT01471574|E3|Reported Event|HAART: Daclatasvir, 30 mg + 60 mg|Participants taking non-nucleoside reverse transcriptase inhibitors, except rilpivirine, received 2 daclatasvir tablets (1x30 mg and 1x60 mg), orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously, once weekly; and ribavirin tablets, orally twice daily for a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780742|NCT01471574|E2|Reported Event|HAART Therapy: Daclatasvir, 60 mg|Participants taking other HAART, including rilpivirine, received daclatasvir tablets, 60 mg, orally once daily; pegIFNalfa-2a solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780743|NCT01471574|E1|Reported Event|Highly Active Anti-Retroviral Therapy (HAART):Daclatasvir,30mg|Participants taking HIV ritonavir-boosted protease inhibitors received daclatasvir tablets, 30 mg, orally once daily; peg-interferon alfa-2a (pegIFNalfa-2a) solution for injection, 180 µg, subcutaneously once weekly; and ribavirin tablets, orally twice daily with a total dose of 1000 mg for participants weighing <75 kg and 1200 mg for those weighing ≥75 kg, for up to 24 weeks. Participants without virologic response at Weeks 4 and 12 continued to receive pegIFNalfa-2a and ribavirin for a total duration of 48 weeks.
780744|NCT01471379|B4|Baseline|Total|Total of all reporting groups
780745|NCT01471379|B3|Baseline|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780746|NCT01471379|B2|Baseline|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
780747|NCT01471379|B1|Baseline|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
780748|NCT01471379|P3|Participant Flow|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780749|NCT01471379|P2|Participant Flow|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
780750|NCT01471379|P1|Participant Flow|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg twice a day (BID) (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran per orally (PO), BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
780751|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780752|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
818108|NCT01333397|O1|Outcome|Placebo|
780755|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
780756|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
780757|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780758|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
780759|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
780760|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780761|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
780762|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
780763|NCT01471379|O3|Outcome|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780764|NCT01471379|O2|Outcome|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
780765|NCT01471379|O1|Outcome|Group A (50mg - 100mg)|"Group A begins treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
780766|NCT01471379|E3|Reported Event|Group C (Placebo - 50mg)|"Group C will begin treatment with Placebo BID (n=20) during Phase I and will be given 50mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Placebo : Inactive pill, identical in shape, size, and appearance to active drug, PO, BID."
780767|NCT01471379|E2|Reported Event|Group B (50mg x12)|"Subjects in this arm will be maintained at Milnacipran 50mg BID for the entirety of the 12 weeks of the study.~Milnacipran : Milnacipran, 50mg PO BID for 12 weeks"
780768|NCT01471379|E1|Reported Event|Group A (50mg - 100mg)|"Group A will begin treatment with Milnacipran 50mg BID (n=20) during Phase I and will be increased to 100mg BID during Phase II~Milnacipran : 50mg Milnacipran PO, BID, for 6 weeks.~Milnacipran : Milnacipran, 100mg PO, BID, for six weeks"
780769|NCT01471353|B1|Baseline|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
780770|NCT01471353|P1|Participant Flow|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
780771|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
780772|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
780773|NCT01471353|O1|Outcome|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
780774|NCT01471353|E1|Reported Event|Sorafenib Plus Capecitabine (SorCape)|"Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days. Single arm study.~Sorafenib Plus Capecitabine (SorCape): Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days"
780775|NCT01471197|B3|Baseline|Total|Total of all reporting groups
780776|NCT01471197|B2|Baseline|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
780777|NCT01471197|B1|Baseline|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
780778|NCT01471197|P2|Participant Flow|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 milligram per meter squared (mg/m^2), Once every 3 weeks during Treatment Phase, 10 minute infusion.
780783|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
818109|NCT01333397|O4|Outcome|Dysport NG 75 U|
780785|NCT01471197|O1|Outcome|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
780786|NCT01471197|E2|Reported Event|Pemetrexed 500 mg/m^2|Pemetrexed: IV solution, IV, 500 mg/m^2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
780787|NCT01471197|E1|Reported Event|Ipilimumab 10 mg/kg|Ipilimumab: Intravenous (IV) solution, IV, 10 milligrams per kilogram (mg/kg), Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion.
780788|NCT01471171|B1|Baseline|Overall Study Safety Population|All patients randomized into the crossover study were included in the safety population
780789|NCT01471171|P2|Participant Flow|Placebo - Aclidinium Bromide 400 μg|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
780790|NCT01471171|P1|Participant Flow|Aclidinium Bromide 400 μg - Placebo|The study consisted of 2 treatment periods of 22 (±2) days separated by a washout period of 14 (-2/+7) days. In treatment period 1, patients received 1 puff of aclidinium bromide 400 μg via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks. In treatment period 2, patients received 1 puff of placebo via the Genuair® multidose dry powder inhaler in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
780791|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
780792|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
780793|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
780794|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
780795|NCT01471171|O2|Outcome|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
780796|NCT01471171|O1|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
780797|NCT01471171|E2|Reported Event|Placebo|Placebo: Oral inhalation by Genuair® multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) for 3 weeks.
780798|NCT01471171|E1|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide: Oral inhalation via Genuair® multidose dry powder inhaler. 1 puff of 400 μg in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h) for 3 weeks.
780799|NCT01471041|B1|Baseline|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
780800|NCT01471041|P1|Participant Flow|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
780801|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
780802|NCT01471041|O1|Outcome|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
780803|NCT01471041|E1|Reported Event|Venous Window Needle Guide|"Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula~Venous Window Needle Guide: Subcutaneous, extravascular needle guide made of medical-grade titanium"
780804|NCT01471015|B4|Baseline|Total|Total of all reporting groups
780805|NCT01471015|B3|Baseline|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
780806|NCT01471015|B2|Baseline|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
780807|NCT01471015|B1|Baseline|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
780808|NCT01471015|P3|Participant Flow|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
780809|NCT01471015|P2|Participant Flow|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
780810|NCT01471015|P1|Participant Flow|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
780811|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
818110|NCT01333397|O3|Outcome|Dysport NG 50 U|
780812|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
780813|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
780814|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
780815|NCT01471015|O3|Outcome|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
780816|NCT01471015|O2|Outcome|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
780817|NCT01471015|O1|Outcome|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
780818|NCT01471015|E3|Reported Event|Placebo|"Placebo given x2 doses, with the first given within 12 hours of delivery and the second given at 7 days old~Placebo: Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old"
780819|NCT01471015|E2|Reported Event|Low Dose Darbepoetin Alfa|"2 mcg/kg/dose Darbe x2, with the first dose given within 12 hours of delivery and the second dose given at 7 days old.~Darbepoetin alfa: 2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old."
780820|NCT01471015|E1|Reported Event|High Dose Darbepoetin Alfa|"10 mcg/kg/dose Darbe x2 doses, with the first dose within 12 hours of delivery and the second dose at 7 days~Darbepoetin alfa: 10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old."
780821|NCT01470859|B3|Baseline|Total|Total of all reporting groups
780822|NCT01470859|B2|Baseline|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780823|NCT01470859|B1|Baseline|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780824|NCT01470859|P2|Participant Flow|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780825|NCT01470859|P1|Participant Flow|Levodopa|"Sinemet Controlled Release (CR)~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780826|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780827|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780828|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780829|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780830|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780831|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780832|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780833|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780834|NCT01470859|O2|Outcome|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780835|NCT01470859|O1|Outcome|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780836|NCT01470859|E2|Reported Event|Pramipexole|"0.375mg-4.5mg/day, flexible dosage according to an optimal improvement of movement dysfunction in PD patients~pramipexole: tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year."
780837|NCT01470859|E1|Reported Event|Levodopa|"Sinemet CR~Sinemet CR: tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year"
780838|NCT01470651|B3|Baseline|Total|Total of all reporting groups
813597|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
780841|NCT01470651|P2|Participant Flow|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
783070|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
780843|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
780844|NCT01470651|O1|Outcome|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
780845|NCT01470651|O2|Outcome|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
780846|NCT01470651|O1|Outcome|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
780847|NCT01470651|E2|Reported Event|Sugar Pill|"Inactive pill, matched to look like active medication~Placebo Comparator: Inactive pill, matched to look like active medication"
780848|NCT01470651|E1|Reported Event|Armodafinil|"Active medication~Armodafinil: 50mg - 250mg pills, taken each morning, for 14 weeks"
780849|NCT01470469|B3|Baseline|Total|Total of all reporting groups
780850|NCT01470469|B2|Baseline|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780851|NCT01470469|B1|Baseline|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780852|NCT01470469|P2|Participant Flow|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780853|NCT01470469|P1|Participant Flow|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780854|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780855|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780856|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780857|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780858|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780859|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780860|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780861|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780862|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780863|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780864|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780865|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780866|NCT01470469|O2|Outcome|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780867|NCT01470469|O1|Outcome|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780868|NCT01470469|E2|Reported Event|SPD503|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks.
780869|NCT01470469|E1|Reported Event|PLACEBO|Once-daily oral dosing in the evening for 12 weeks.
780870|NCT01470417|B3|Baseline|Total|Total of all reporting groups
780871|NCT01470417|B2|Baseline|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
780872|NCT01470417|B1|Baseline|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
780873|NCT01470417|P2|Participant Flow|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
780874|NCT01470417|P1|Participant Flow|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
780897|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780958|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780959|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
818111|NCT01333397|O2|Outcome|Dysport NG 20 U|
780875|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
780876|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
780877|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
780878|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
780879|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
780880|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
780881|NCT01470417|O2|Outcome|Chemotherapy + ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy + ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
780882|NCT01470417|O1|Outcome|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
780883|NCT01470417|E2|Reported Event|Chemotherapy and ChemoRadiotherapy|"Individuals with high-risk disease or borderline resectable disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.~Chemotherapy and ChemoRadiotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection."
780884|NCT01470417|E1|Reported Event|Chemotherapy|"Individuals with low risk disease will receive nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.~Chemotherapy: Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection."
780956|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
813598|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
780885|NCT01470248|B1|Baseline|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
780886|NCT01470248|P1|Participant Flow|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
780887|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
780888|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
780889|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
780890|NCT01470248|O1|Outcome|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
780891|NCT01470248|E1|Reported Event|Arsenic Trioxide Treatment|"This is a single arm study. All patients will be treated with the investigational agent, Arsenic Trioxide, according to the dose and schedule indicated in the protocol.~Arsenic Trioxide: Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects"
780892|NCT01470196|B1|Baseline|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780893|NCT01470196|P1|Participant Flow|Carfilzomib, Dexamethasone, and Rituximab|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780894|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780895|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780896|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780957|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
813662|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
780898|NCT01470196|O1|Outcome|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780899|NCT01470196|E1|Reported Event|Treatment Arm|"Carfilzomib, dexamethasone, rituximab~Dexamethasone: 20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8~Carfilzomib: 20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8~Rituximab: 375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8"
780900|NCT01470170|B6|Baseline|Total|Total of all reporting groups
780901|NCT01470170|B5|Baseline|Group 5/ Control|Propofol alone
780902|NCT01470170|B4|Baseline|Group 4|alfentanil 5ug/kg two minutes before propofol
780903|NCT01470170|B3|Baseline|Group 3|alfentanil 5ug/kg immediately before propofol
780904|NCT01470170|B2|Baseline|Group 2|alfentanil 2.5ug/kg two minutes before propofol
780905|NCT01470170|B1|Baseline|Group1|alfentanil 2.5ug/kg immediately before propofol
780906|NCT01470170|P5|Participant Flow|Group 5 Control|TCI propofol administration alone
780907|NCT01470170|P4|Participant Flow|Group 4|Alfentanil 5μg/kg two minutes before TCI propofol administration
780908|NCT01470170|P3|Participant Flow|Group 3|Alfentanil 2.5μg/kg two minutes before TCI propofol administration
780909|NCT01470170|P2|Participant Flow|Group2|Alfentanil 5μg/kg immediately before TCI propofol administration
780910|NCT01470170|P1|Participant Flow|Group1|Alfentanil 2.5μg/kg immediately before TCI propofol administration
780911|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
780912|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
780913|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
780914|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
780915|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
780916|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
780917|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
780918|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
780919|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
780920|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
780921|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
780922|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
780923|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
780924|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
780925|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
780926|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
780927|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
780928|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
780929|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
780930|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
780931|NCT01470170|O5|Outcome|Group 5 /Control|Propofol alone
780932|NCT01470170|O4|Outcome|Group 4|alfentanil 5ug/kg two minutes before propofol
780933|NCT01470170|O3|Outcome|Group 3|alfentanil 5ug/kg immediately before propofol
780934|NCT01470170|O2|Outcome|Group 2|alfentanil 2.5ug/kg two minutes before propofol
780935|NCT01470170|O1|Outcome|Group1|alfentanil 2.5ug/kg immediately before propofol
780936|NCT01470170|E5|Reported Event|Group 5 /Control|Propofol alone
780937|NCT01470170|E4|Reported Event|Group 4|alfentanil 5ug/kg two minutes before propofol
780938|NCT01470170|E3|Reported Event|Group 3|alfentanil 5ug/kg immediately before propofol
780939|NCT01470170|E2|Reported Event|Group 2|alfentanil 2.5ug/kg two minutes before propofol
780940|NCT01470170|E1|Reported Event|Group1|alfentanil 2.5ug/kg immediately before propofol
780941|NCT01470144|B1|Baseline|Treatment|All patients who received at least one dose of EFI
780942|NCT01470144|P1|Participant Flow|Treatment|All patients who received at least one dose of EFI
780943|NCT01470144|O1|Outcome|Treatment|
780944|NCT01470144|O1|Outcome|Treatment|All patients who received at least one dose of EFI
780945|NCT01470144|E1|Reported Event|Treatment|
780946|NCT01470118|B4|Baseline|Total|Total of all reporting groups
780947|NCT01470118|B3|Baseline|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780948|NCT01470118|B2|Baseline|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780949|NCT01470118|B1|Baseline|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780950|NCT01470118|P3|Participant Flow|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780951|NCT01470118|P2|Participant Flow|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780952|NCT01470118|P1|Participant Flow|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780953|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780954|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780955|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780960|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780961|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780962|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780963|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780964|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780965|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780966|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780967|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780968|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780969|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780970|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780971|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780972|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780973|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780974|NCT01470118|O3|Outcome|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780975|NCT01470118|O2|Outcome|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780976|NCT01470118|O1|Outcome|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780977|NCT01470118|E3|Reported Event|Placebo (Dextran 70 0.1%/Hydroxypropyl Methylcellulose 0.3%)|One drop of placebo instilled in each eye at Day 0 and Day 14.
780978|NCT01470118|E2|Reported Event|Pataday™ (Olopatadine 0.2%)|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780979|NCT01470118|E1|Reported Event|LASTACAFT® (Alcaftadine 0.25%)|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
780980|NCT01469819|B1|Baseline|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
780981|NCT01469819|P1|Participant Flow|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
780982|NCT01469819|O1|Outcome|SIBO (+)|Twenty-five patients were tested for SIBO before treatment with lubiprostone and 17 (68.0%) were SIBO (+) at baseline.
780983|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement
780984|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as > 2 times increase in their weekly bowel movement compared to baseline.
780985|NCT01469819|O2|Outcome|Non-Responders|Subgroup of patients who had <2 times increase in their weekly bowel movement.
780986|NCT01469819|O1|Outcome|Responders|Subgroup of patients who clinically responded to lubiprostone defined as ≥ 2 times increase in their weekly bowel movement.
780987|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients aster all inclusionary criteria were met.
780988|NCT01469819|O1|Outcome|All Participants|Due to the nature of this project, which did not include placebo, blinded portion of the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
780989|NCT01469819|E1|Reported Event|All Participants|Due to the nature of this project, which did not include placebo, blinded portion to the investigation, all patients were exposed to study drug in a similar design. Lubiprostone 24 micrograms twice a day for 14 consecutive days was provided for qualified patients after all inclusionary criteria were met.
780990|NCT01469767|B1|Baseline|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
780991|NCT01469767|P1|Participant Flow|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
780992|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
780993|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
780994|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
781121|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
780995|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
781123|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
780996|NCT01469767|O1|Outcome|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
780997|NCT01469767|E1|Reported Event|Fluocinonide Cream|"Subjects will apply fluocinonide cream 0.1% twice daily for 5 days.~Fluocinonide cream: Fluocinonide cream 0.1% applied twice daily for 5 days."
780998|NCT01469715|B1|Baseline|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
780999|NCT01469715|P1|Participant Flow|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
781000|NCT01469715|O1|Outcome|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
781001|NCT01469715|E1|Reported Event|GBP-CGM|"All participants will wear one active GBP-CGM and one inactive GBP-CGM~GBP CGM: Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5."
781002|NCT01469637|B3|Baseline|Total|Total of all reporting groups
781003|NCT01469637|B2|Baseline|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
781004|NCT01469637|B1|Baseline|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
781005|NCT01469637|P2|Participant Flow|Sulfamethoxazole + MMX Mesalazine/Mesalamine First|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for second intervention.
781006|NCT01469637|P1|Participant Flow|Sulfamethoxazole + MMX Placebo First|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4 for first intervention; then 800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4 for second intervention.
781007|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
781008|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
781009|NCT01469637|O2|Outcome|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
781010|NCT01469637|O1|Outcome|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
781055|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781057|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
818112|NCT01333397|O1|Outcome|Placebo|
781011|NCT01469637|E2|Reported Event|Sulfamethoxazole + MMX Mesalazine/Mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4.
781012|NCT01469637|E1|Reported Event|Sulfamethoxazole + MMX Placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX placebo once daily (QD) orally for 3 days and a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX placebo orally on Day 4.
781013|NCT01469546|B1|Baseline|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
781014|NCT01469546|P1|Participant Flow|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
781015|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
781016|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
781017|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
781018|NCT01469546|O1|Outcome|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
781019|NCT01469546|E1|Reported Event|Axitinib (AG-013736)|Axitinib (AG-013736): The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities.
781020|NCT01469364|B1|Baseline|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781021|NCT01469364|P1|Participant Flow|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781022|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781023|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781024|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781025|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781026|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781027|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781056|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781028|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781029|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781030|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781031|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781032|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781033|NCT01469364|O1|Outcome|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781034|NCT01469364|E1|Reported Event|Aztreonam Lysine for Inhalation (AZLI)|"Patients to received Aztreonam Lysine(AZLI)~Aztreonam Lysine for Inhalation (AZLI): The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)~Status Post Lung Transplant: Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care."
781035|NCT01469234|B4|Baseline|Total|Total of all reporting groups
781036|NCT01469234|B3|Baseline|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781037|NCT01469234|B2|Baseline|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781038|NCT01469234|B1|Baseline|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781039|NCT01469234|P3|Participant Flow|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781040|NCT01469234|P2|Participant Flow|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781041|NCT01469234|P1|Participant Flow|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781042|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781043|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781044|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781045|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781046|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781047|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781048|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781049|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781050|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781051|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781052|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781053|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781054|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781113|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781058|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781059|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781060|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781061|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781062|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781063|NCT01469234|O3|Outcome|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781064|NCT01469234|O2|Outcome|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781065|NCT01469234|O1|Outcome|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781066|NCT01469234|E3|Reported Event|Placebo|Participants received one dose of placebo following randomization at 120 minutes of exposure during visit 4.
781067|NCT01469234|E2|Reported Event|Fexofenadine|Participants received one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
781068|NCT01469234|E1|Reported Event|Loratadine|Participants received one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
781069|NCT01469182|B3|Baseline|Total|Total of all reporting groups
781070|NCT01469182|B2|Baseline|Placebo|Matching placebo tablet, sublingual, once daily.
781071|NCT01469182|B1|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781072|NCT01469182|P2|Participant Flow|Placebo|Matching placebo tablet, sublingual, once daily.
781073|NCT01469182|P1|Participant Flow|SCH 39641 12 Amb a 1-U|12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily.
781074|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781075|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781076|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781077|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781078|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781079|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781080|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781081|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781082|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781083|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781084|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781085|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781086|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781087|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781088|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781089|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781090|NCT01469182|O2|Outcome|Placebo|Matching placebo tablet, sublingual, once daily.
781091|NCT01469182|O1|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781092|NCT01469182|E2|Reported Event|Placebo|Matching placebo tablet, sublingual, once daily.
781093|NCT01469182|E1|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U extract in an AIT, sublingual, once daily.
781094|NCT01469065|B6|Baseline|Total|Total of all reporting groups
781095|NCT01469065|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781096|NCT01469065|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781097|NCT01469065|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781098|NCT01469065|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781099|NCT01469065|B1|Baseline|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
781100|NCT01469065|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781101|NCT01469065|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781102|NCT01469065|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781103|NCT01469065|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781104|NCT01469065|P1|Participant Flow|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
781105|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781106|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781107|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781108|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781109|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
781110|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781111|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781112|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
814969|NCT01344447|O2|Outcome|Unenhanced MRA|
781122|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781128|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781129|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
781130|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781131|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781132|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781133|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781134|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
781135|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781136|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781137|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781138|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781139|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781140|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781141|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781142|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781143|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781144|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781145|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781146|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781147|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781148|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781149|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781150|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781151|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781152|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781153|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781154|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781155|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781156|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781157|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781158|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781159|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781160|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781161|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781162|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781163|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781164|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781165|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781166|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781167|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781168|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781169|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781170|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781171|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781172|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781173|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781174|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781175|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781176|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781177|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781178|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781179|NCT01469065|O4|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781180|NCT01469065|O3|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781181|NCT01469065|O2|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781182|NCT01469065|O1|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781183|NCT01469065|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781184|NCT01469065|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781185|NCT01469065|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781186|NCT01469065|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781187|NCT01469065|O1|Outcome|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
781188|NCT01469065|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily for 2 weeks.
781189|NCT01469065|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily for 2 weeks.
781190|NCT01469065|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily for 2 weeks.
781191|NCT01469065|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 milligram (mg) tablet orally twice daily for 2 weeks.
781192|NCT01469065|E1|Reported Event|Placebo|PF-04991532 matching placebo orally twice daily for 2 weeks.
781193|NCT01469052|B7|Baseline|Total|Total of all reporting groups
781194|NCT01469052|B6|Baseline|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781195|NCT01469052|B5|Baseline|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781196|NCT01469052|B4|Baseline|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781197|NCT01469052|B3|Baseline|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781198|NCT01469052|B2|Baseline|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781199|NCT01469052|B1|Baseline|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781200|NCT01469052|P6|Participant Flow|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781201|NCT01469052|P5|Participant Flow|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781202|NCT01469052|P4|Participant Flow|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781203|NCT01469052|P3|Participant Flow|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781204|NCT01469052|P2|Participant Flow|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781205|NCT01469052|P1|Participant Flow|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 milligram (mg) tablet orally once daily (QD) followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally twice daily (BID) in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781206|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
781207|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
781208|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
781209|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
781210|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
781211|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
781212|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
781213|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
781214|NCT01469052|O2|Outcome|Fasted State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fasted state in cycles of 4 weeks, up to 8 cycles.
781215|NCT01469052|O1|Outcome|Fed State|Axitinib (AG-013736) tablet 5 mg BID, 15 mg QD and 20 mg BID were administered orally in fed state in cycles of 4 weeks, up to 8 cycles.
781216|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781217|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781218|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781219|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781220|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781221|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781222|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781223|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781224|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781225|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781226|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781227|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781228|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781229|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781230|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781231|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781232|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781233|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781234|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781235|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781236|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781237|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781238|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781239|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781240|NCT01469052|O6|Outcome|Cohort 6: Axitinib 2 mg + 5 mg BID, Fasted|Axitinib (AG-013736) 2 mg tablet orally BID on the first day of dosing followed by 5 mg BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781241|NCT01469052|O5|Outcome|Cohort 5: Axitinib 5 mg BID, Fasted|Axitinib (AG-013736) 5 mg tablet orally BID in fasted state continuously in cycles of 4 weeks, up to 8 cycles.
781242|NCT01469052|O4|Outcome|Cohort 4: Axitinib 15 mg QD, Fed|Axitinib (AG-013736) 15 mg tablet orally QD in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781243|NCT01469052|O3|Outcome|Cohort 3: Axitinib 5 mg BID, Fed|Axitinib (AG-013736) 5 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781244|NCT01469052|O2|Outcome|Cohort 2: Axitinib 20 mg BID, Fed|Axitinib (AG-013736) 20 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781245|NCT01469052|O1|Outcome|Cohort 1: Axitinib (10 mg QD + 10 mg/20mg/30mg BID), Fed|Single dose of axitinib (AG-013736) 10 mg tablet orally QD followed by 30 mg single dose after 48 hours. Axitinib (AG-013736) 10 mg/ 20 mg/ 30 mg tablet orally BID in fed state continuously in cycles of 4 weeks, up to 8 cycles.
781246|NCT01469052|O1|Outcome|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
781247|NCT01469052|E1|Reported Event|All Treated Participants|All participants of Cohorts 1 to 6 received oral doses of axitinib (AG-013736) (10 mg and 15 mg, QD; 2 mg, 5 mg, 10 mg, 20 mg and 30 mg, BID) tablet in fed or fasted state in cycles of 4 weeks, up to 8 cycles.
781248|NCT01469039|B4|Baseline|Total|Total of all reporting groups
781249|NCT01469039|B3|Baseline|Placebo|Intramuscular injection, given monthly
781250|NCT01469039|B2|Baseline|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
781251|NCT01469039|B1|Baseline|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
781252|NCT01469039|P3|Participant Flow|Placebo|Intramuscular injection, given monthly
781253|NCT01469039|P2|Participant Flow|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
781254|NCT01469039|P1|Participant Flow|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
781255|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
781256|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
781257|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
781258|NCT01469039|O3|Outcome|Placebo|Intramuscular injection, given monthly
781259|NCT01469039|O2|Outcome|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
781260|NCT01469039|O1|Outcome|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
781261|NCT01469039|E3|Reported Event|Placebo|Intramuscular injection, given monthly
781262|NCT01469039|E2|Reported Event|Aripiprazole Lauroxil 882 mg|Intramuscular injection, given monthly
814970|NCT01344447|O1|Outcome|Gadobutrol-Enhanced MRA|
781263|NCT01469039|E1|Reported Event|Aripiprazole Lauroxil 441 mg|Intramuscular injection, given monthly
781264|NCT01469000|B3|Baseline|Total|Total of all reporting groups
781265|NCT01469000|B2|Baseline|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
781266|NCT01469000|B1|Baseline|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781267|NCT01469000|P2|Participant Flow|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
784468|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
781268|NCT01469000|P1|Participant Flow|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781269|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
781270|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781271|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
781272|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781273|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
781274|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781275|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
781276|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781277|NCT01469000|O2|Outcome|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
781278|NCT01469000|O1|Outcome|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781279|NCT01469000|E2|Reported Event|250 mg Gefitinib|250 mg Gefitinib taken orally once QD
781280|NCT01469000|E1|Reported Event|250 mg Gefitinib/500 mg Pemetrexed|250 milligrams (mg) Gefitinib taken orally once daily (QD) and 500 milligrams per square meter (mg/m²) Pemetrexed taken intravenously (IV) once every 3 weeks concurrently with Gefitinib QD.
781281|NCT01468818|B1|Baseline|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
781282|NCT01468818|P1|Participant Flow|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
781283|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
781284|NCT01468818|O1|Outcome|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
781285|NCT01468818|E1|Reported Event|Immunotherapy for Metastatic Melanoma|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of:~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.~Fludarabine: Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.~Young Tumor Infiltrating Lymphocytes (TIL): Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine)."
781286|NCT01468675|B3|Baseline|Total|Total of all reporting groups
781287|NCT01468675|B2|Baseline|Control|Usual Care
781288|NCT01468675|B1|Baseline|Intervention|Risk Assessment and Prevention Recommendations provided to subjects
781289|NCT01468675|P2|Participant Flow|Control|Control - Usual Care
781290|NCT01468675|P1|Participant Flow|Intervention|Risk Assessment and Prevention Recommendations
781291|NCT01468675|O2|Outcome|Control|Usual care
781292|NCT01468675|O1|Outcome|Intervention|"Validated, web-based risk assessment is being used to assess personalized risk and generate a risk report~risk assessment survey; decision support for providers for prevention based on risk"
781293|NCT01468675|E2|Reported Event|Control|Control subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) AFTER their primary care visit. Coded data was not sent to the EHR.
781294|NCT01468675|E1|Reported Event|Intervention|Intervention subjects completed a risk factors/perceptions assessment and received a 1 page Health Risk Assessment (HRA) prior to a primary care visit. This coded data was sent to the EHR. After their primary care visit, subjects again reported risk perception.
781295|NCT01468584|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
781296|NCT01468584|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
781297|NCT01468584|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
781298|NCT01468584|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
781299|NCT01468558|B1|Baseline|Overall Study|All subjects that were enrolled in the study.
781300|NCT01468558|P1|Participant Flow|Overall Study|Subjects first received MAP0004 1.0mg via oral inhalation followed by 48 hours of PK sampling, they then received Ketoconazole (400mg once a day for 4 days) followed by MAP0004 1.0mg and another 48 hours of PK sampling. After a 7-11 day washout, subjects returned to the clinic to receive 1.0mg IV DHE and 48 hours of PK sampling.
781301|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
781302|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
781303|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
781304|NCT01468558|O3|Outcome|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
781305|NCT01468558|O2|Outcome|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
781306|NCT01468558|O1|Outcome|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
781307|NCT01468558|E3|Reported Event|IV DHE 1.0mg|IV DHE 1.0mg on Day 1 of Visit 3.
781308|NCT01468558|E2|Reported Event|MAP0004 1.0mg + Ketoconazole|Ketoconazole 400mg once a day on Days 3-6 of Visit 2 and MAP0004 1.0mg via inhalation on Day 6 of Visit 2.
781309|NCT01468558|E1|Reported Event|MAP0004 1.0mg|MAP0004 1.0mg via inhalation on Day 1 of Visit 2.
781310|NCT01468350|B5|Baseline|Total|Total of all reporting groups
781311|NCT01468350|B4|Baseline|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
781312|NCT01468350|B3|Baseline|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
781313|NCT01468350|B2|Baseline|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
781314|NCT01468350|B1|Baseline|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
781315|NCT01468350|P4|Participant Flow|(PART B) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive multiple doses of (A) dalfampridine-ER 10mg and multiple doses of (B) placebo~Day 1, visit 2, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 dose for 1 day. Day 15, visit 4, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day"
781316|NCT01468350|P3|Participant Flow|(PART B) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive multiple doses of (B) placebo, and multiple doses of (A) dalfampridine-ER 10mg~Day 1, visit 2, subjects will be given 15 tablets of placebo taken twice daily for 7 days and an additional 1 tablet for 1 day. Day 15, visit 4, subjects will be given 15 tablets dalfampridine-ER taken twice daily for 7 days and an additional 1 tablet for 1 day"
781317|NCT01468350|P2|Participant Flow|(PART A) Dalfampridine-ER 10mg Then Placebo|"Each subject randomized to the AB arm will receive a single witnessed dose of (A) dalfampridine-ER 10 mg, and a single witnessed dose of (B) placebo, two days apart~Day 1, visit 2, subjects will receive dalfampridine-ER 10mg. Day 3, visit 3 subjects will receive placebo"
781318|NCT01468350|P1|Participant Flow|(PART A) Placebo Then Dalfampridine-ER 10mg|"Each subject randomized to the BA arm will receive a single witnessed dose of (B) placebo, and a single witnessed dose of (A) dalfampridine-ER 10 mg, two days apart~Day 1, visit 2, subjects will receive placebo. Day 3, visit 3, subjects will receive dalfampridine-ER 10mg"
781319|NCT01468350|O4|Outcome|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
781361|NCT01468233|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
781320|NCT01468350|O3|Outcome|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
781321|NCT01468350|O2|Outcome|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
823189|NCT01316315|E1|Reported Event|Active|N6022 - Active 5 mg
781322|NCT01468350|O1|Outcome|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
781323|NCT01468350|E4|Reported Event|PART B: Dalfampridine-ER 10mg|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
781324|NCT01468350|E3|Reported Event|PART B: Placebo|"12 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 12 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~Subjects received multiple doses of placebo and multiple doses of dalfampridine-ER 10mg"
781325|NCT01468350|E2|Reported Event|PART A: Dalfampridine-ER 10mg|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
781326|NCT01468350|E1|Reported Event|PART A: Placebo|"6 subjects randomized into Sequence BA (placebo – dalfampridine-ER) 5 subjects randomized into Sequence AB (dalfampridine-ER - placebo)~A single witnessed dose of placebo and a single witnessed dose of dalfampridine-ER 10 mg, two days apart"
781327|NCT01468337|B1|Baseline|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781328|NCT01468337|P1|Participant Flow|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781329|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781330|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781331|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781332|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781362|NCT01468233|O2|Outcome|Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781363|NCT01468233|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
782785|NCT01463878|O2|Outcome|Control - Jevity|The control arm of the study. Patients to receive Jevity
781365|NCT01468233|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781366|NCT01468233|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
782866|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
781333|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781334|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781335|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781336|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781337|NCT01468337|O1|Outcome|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781338|NCT01468337|E1|Reported Event|Interferon Gamma-1b|"Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. A single dropperette contains 1 mL of topical interferon gamma-1b (Actimmune®) at a concentration of 200 µg/mL, which is equivalent to 28 drops. Each drop provides a dose of 7 µg of investigational product.~All participants will receive interferon gamma-1b for two weeks. Doses of interferon gamma-1b eye drops will be escalated among participants during this initial 2-week period; however, additional doses will be dispensed to participants if needed at Week 4 or after the initial 8-week study period. Participants eligible for additional doses after 8 weeks will be administered the maximum dose of 4 drops 4 times daily for a total daily dose of 112 μg."
781339|NCT01468311|B1|Baseline|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781340|NCT01468311|P1|Participant Flow|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781341|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781364|NCT01468233|O6|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781543|NCT01467934|P3|Participant Flow|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5ml IM x 1
781342|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781343|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781344|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781345|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781346|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781347|NCT01468311|O1|Outcome|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781348|NCT01468311|E1|Reported Event|Yttrium-90-labeled Daclizumab + Chemotherapy|"Yttrium-90-labeled Daclizumab + BCNU, etoposide, cytarabine and melphalan (BEAM) + Auto stem cell transplant (ASCT)~Auto stem cell transplant: Auto stem cell transplant (ASCT) is given after 90Y-daclizumab~BEAM: BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab~111In-daclizumab: 111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.~90Y-daclizumab: 90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant"
781349|NCT01468233|B3|Baseline|Total|Total of all reporting groups
781350|NCT01468233|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781351|NCT01468233|B1|Baseline|Placebo|Placebo for 12 weeks
781352|NCT01468233|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781353|NCT01468233|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
781354|NCT01468233|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781355|NCT01468233|P3|Participant Flow|Placebo/Placebo|Participants randomized to receive placebo in Period 1 received placebo every week from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781356|NCT01468233|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781357|NCT01468233|P1|Participant Flow|Placebo|Placebo for 12 weeks
781358|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781359|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
781360|NCT01468233|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline Patient's Global Assessment of Skin Pain Numeric Rating Scale (NRS) ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781402|NCT01468207|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks
781403|NCT01468181|B6|Baseline|Total|Total of all reporting groups
781367|NCT01468233|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks
781368|NCT01468233|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781369|NCT01468233|O1|Outcome|Placebo|Placebo for 12 weeks
781370|NCT01468233|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781371|NCT01468233|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
781372|NCT01468233|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781373|NCT01468233|E3|Reported Event|Placebo/Placebo (Period 2)|Participants randomized to receive placebo in Period 1 received placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781374|NCT01468233|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781375|NCT01468233|E1|Reported Event|Placebo (Period 1)|Placebo for 12 weeks.
781376|NCT01468207|B3|Baseline|Total|Total of all reporting groups
781377|NCT01468207|B2|Baseline|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781378|NCT01468207|B1|Baseline|Placebo|Placebo for 12 weeks.
781379|NCT01468207|P6|Participant Flow|Adalimumab Every Week (EW)/Adalimumab Every Week (EW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781380|NCT01468207|P5|Participant Flow|Adalimumab Every Week (EW)/ Adalimumab Every Other Week (EOW)|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive adalimumab 40 mg eow from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
781381|NCT01468207|P4|Participant Flow|Adalimumab Every Week (EW)/Placebo|Participants randomized to receive adalimumab ew in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781382|NCT01468207|P3|Participant Flow|Placebo/Adalimumab Every Week (EW)|Participants randomized to receive placebo in Period 1 received adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to Week 35 in Period 2 (up to 24 weeks).
781383|NCT01468207|P2|Participant Flow|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781384|NCT01468207|P1|Participant Flow|Placebo|Placebo for 12 weeks.
781385|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781386|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
781387|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781388|NCT01468207|O1|Outcome|Placebo - Baseline NRS at Worst ≥ 3|Participants with baseline NRS ≥ 3 randomized to receive placebo every week (ew) for 12 weeks.
781389|NCT01468207|O2|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781390|NCT01468207|O1|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
781391|NCT01468207|O6|Outcome|Adalimumab Every Week (ew) - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781392|NCT01468207|O5|Outcome|Adalimumab Every Week (EW) - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive adalimumab ew 160 mg at Week 12, 80 mg at Week 14, and 40 mg ew from Week 16 to 35 (up to 24 weeks).
781393|NCT01468207|O4|Outcome|Placebo - Baseline Hurley Stage III|Participants with baseline Hurley Stage III randomized to receive placebo every week (ew) for 12 weeks.
781394|NCT01468207|O3|Outcome|Placebo - Baseline Hurley Stage II|Participants with baseline Hurley Stage II randomized to receive placebo every week (ew) for 12 weeks.
781395|NCT01468207|O2|Outcome|Adalimumab Every Week (EW)|Adalimumab ew for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781396|NCT01468207|O1|Outcome|Placebo|Placebo for 12 weeks.
781397|NCT01468207|E6|Reported Event|Adalimumab EW/Adalimumab EW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive 40 mg adalimumab ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781398|NCT01468207|E5|Reported Event|Adalimumab EW/Adalimumab EOW (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive adalimumab 40 mg every other week (eow) from Week 12 to Week 35 in Period 2; placebo injections were administered eow from Week 13 to Week 35 (up to 24 weeks).
781399|NCT01468207|E4|Reported Event|Adalimumab EW/Placebo (Period 2)|Participants randomized to receive adalimumab every week (ew) in Period 1 were re-randomized to receive placebo ew from Week 12 to Week 35 in Period 2 (up to 24 weeks).
781400|NCT01468207|E3|Reported Event|Placebo/Adalimumab EW (Period 2)|Participants randomized to receive placebo in Period 1 were re-randomized to receive adalimumab 160 mg at Week 12, 80 mg at Week 14, and 40 mg every week (ew) from Week 16 to Week 35 in Period 2 (up to 24 weeks).
781401|NCT01468207|E2|Reported Event|Adalimumab EW (Period 1)|Adalimumab every week (ew) for 12 weeks (160 mg at Week 0; 80 mg at Week 2; and 40 mg ew from Week 4 to Week 12).
781404|NCT01468181|B5|Baseline|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781545|NCT01467934|P1|Participant Flow|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine 0.25ml IM X 1
781405|NCT01468181|B4|Baseline|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781406|NCT01468181|B3|Baseline|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781407|NCT01468181|B2|Baseline|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781408|NCT01468181|B1|Baseline|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781409|NCT01468181|P5|Participant Flow|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781410|NCT01468181|P4|Participant Flow|LY2189265 + Thiazolidin Edione (TZD)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781411|NCT01468181|P3|Participant Flow|LY2189265 + Alpha-glucosidas e Inhibitor (a-GI)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781412|NCT01468181|P2|Participant Flow|LY2189265 + Biguanides (BG)|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781413|NCT01468181|P1|Participant Flow|LY2189265 + Sulfonylureas (SU)|"LY2189265: 0.75 milligrams (mg) administered subcutaneously (SC), once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781414|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781415|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781416|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781417|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781418|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781419|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781420|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781421|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781422|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781423|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781424|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781425|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781426|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781427|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781428|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781429|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781430|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781431|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781432|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781433|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781434|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781435|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781436|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781437|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781438|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781439|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781440|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781441|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781442|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781443|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781444|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781445|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781446|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781447|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781448|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781449|NCT01468181|O5|Outcome|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781450|NCT01468181|O4|Outcome|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781451|NCT01468181|O3|Outcome|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781452|NCT01468181|O2|Outcome|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781453|NCT01468181|O1|Outcome|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781454|NCT01468181|E5|Reported Event|LY2189265 + Glinides|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of glinides monotherapy throughout the study."
781455|NCT01468181|E4|Reported Event|LY2189265 + TZD|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of TZD monotherapy throughout the study."
781456|NCT01468181|E3|Reported Event|LY2189265 + a-GI|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of a-GI monotherapy throughout the study."
781457|NCT01468181|E2|Reported Event|LY2189265 + BG|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of BG monotherapy throughout the study."
781458|NCT01468181|E1|Reported Event|LY2189265 + SU|"LY2189265: 0.75 mg administered SC, once weekly for 52 weeks~Participants were to continue on their stable, pre-study, physician-prescribed dose of SU monotherapy throughout the study."
781459|NCT01468077|B3|Baseline|Total|Total of all reporting groups
781460|NCT01468077|B2|Baseline|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781461|NCT01468077|B1|Baseline|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781462|NCT01468077|P2|Participant Flow|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781463|NCT01468077|P1|Participant Flow|Tocilizumab, Normal Administration|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
782786|NCT01463878|O1|Outcome|Glycerna|Diabetic specific formula
781464|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781465|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781466|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781467|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781468|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781469|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781470|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781471|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781472|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781473|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781474|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781475|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781476|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781477|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781478|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781479|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781480|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781481|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781482|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781483|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781484|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781485|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781486|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781487|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781488|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781489|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781490|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781491|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781542|NCT01467934|B1|Baseline|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
781492|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781493|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781494|NCT01468077|O2|Outcome|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781495|NCT01468077|O1|Outcome|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781496|NCT01468077|E2|Reported Event|Tocilizumab, Fast Administration|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a total of 6 infusions during the 24-week treatment period. The first infusion (Baseline) was given over 60 minutes, and over 31 minutes the following 5 infusions.
781497|NCT01468077|E1|Reported Event|Tocilizumab, Normal Administration|Participants received tocilizumab 8 mg/kg IV over 60 minutes once every 4 weeks for a total of 6 infusions during the 24-week treatment period.
781498|NCT01468012|B4|Baseline|Total|Total of all reporting groups
781499|NCT01468012|B3|Baseline|Non-randomized|
781500|NCT01468012|B2|Baseline|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
781501|NCT01468012|B1|Baseline|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
781502|NCT01468012|P3|Participant Flow|Non-randomized|
781503|NCT01468012|P2|Participant Flow|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
781504|NCT01468012|P1|Participant Flow|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
781505|NCT01468012|O2|Outcome|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
781506|NCT01468012|O1|Outcome|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
781507|NCT01468012|E2|Reported Event|Placebo|"placebo~Placebo: matched placebo for LCE condition dosed twice daily"
781508|NCT01468012|E1|Reported Event|Levodopa Carbidopa and Entacapone (LCE)|"400mg/100mg/200mg, twice daily dosing of levodopa carbidopa and entacapone (LCE)~levodopa carbidopa and entacapone (LCE): 400mg/100mg/200mg, twice daily"
781509|NCT01467960|B7|Baseline|Total|Total of all reporting groups
781510|NCT01467960|B6|Baseline|Group C|Patients at stage > than II, H&Y
781511|NCT01467960|B5|Baseline|Group B|Patients at Stage II, H&Y
781512|NCT01467960|B4|Baseline|Group A|Patients at Stage I, H&Y
781513|NCT01467960|B3|Baseline|Group III|Healthy Subjects aged more than 65
781514|NCT01467960|B2|Baseline|Group II|Healthy Subjects aged 40-65
781515|NCT01467960|B1|Baseline|Group I|Healthy Subjects aged 20-40
781516|NCT01467960|P6|Participant Flow|Group C|30 Patients at Stage more than III, H&Y classification
781517|NCT01467960|P5|Participant Flow|Group B|30 Patients at Stage II, H&Y classification
781518|NCT01467960|P4|Participant Flow|Group A|30 Patients at Stage I, H&Y classification
781519|NCT01467960|P3|Participant Flow|Group III|30 Healthy Subjects aged more than 65
781520|NCT01467960|P2|Participant Flow|Group II|30 Healthy Subjects aged 40-65
781521|NCT01467960|P1|Participant Flow|Group I|30 Healthy Subjects aged 20-40
781522|NCT01467960|O6|Outcome|Group C|Patients at stage > than II, H&Y
781523|NCT01467960|O5|Outcome|Group B|Patients at Stage II, H&Y
781524|NCT01467960|O4|Outcome|Group A|Patients at Stage I, H&Y
781525|NCT01467960|O3|Outcome|Group III|Healthy Subjects aged more than 65
781526|NCT01467960|O2|Outcome|Group II|Healthy Subjects aged 40-65
781527|NCT01467960|O1|Outcome|Group I|Healthy Subjects aged 20-40
781528|NCT01467960|E6|Reported Event|Group C|Patients at stage > than II, H&Y
781529|NCT01467960|E5|Reported Event|Group B|Patients at Stage II, H&Y
781530|NCT01467960|E4|Reported Event|Group A|Patients at Stage I, H&Y
781531|NCT01467960|E3|Reported Event|Group III|Healthy Subjects aged more than 65
781532|NCT01467960|E2|Reported Event|Group II|Healthy Subjects aged 40-65
781533|NCT01467960|E1|Reported Event|Group I|Healthy Subjects aged 20-40
781534|NCT01467947|B1|Baseline|C1 Esterase Inhibitor|Subjects received 20 IU/kg C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
781535|NCT01467947|P1|Participant Flow|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
781536|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
781537|NCT01467947|O1|Outcome|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
781538|NCT01467947|E1|Reported Event|C1 Esterase Inhibitor|Subjects received 20 IU C1 Esterase Inhibitor (C1-INH)/kg body weight by slow intravenous infusion for each acute HAE attack requiring treatment during a 9-month period beginning after their first HAE attack while on study.
781539|NCT01467934|B4|Baseline|Total|Total of all reporting groups
781540|NCT01467934|B3|Baseline|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
781541|NCT01467934|B2|Baseline|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
781544|NCT01467934|P2|Participant Flow|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
823190|NCT01316302|B3|Baseline|Total|Total of all reporting groups
781546|NCT01467934|O3|Outcome|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
781547|NCT01467934|O2|Outcome|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
781548|NCT01467934|O1|Outcome|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
781549|NCT01467934|E3|Reported Event|13-valent Pneumococcal Conjugate Vaccine (PCV13) Alone|13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
781550|NCT01467934|E2|Reported Event|TIV and PCV13 Together|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1; 13-valent pneumococcal conjugate vaccine (PCV13) 0.5 mL IM x1
781551|NCT01467934|E1|Reported Event|Trivalent Inactivated Influenza Vaccine (TIV) Alone|Trivalent inactivated influenza vaccine (TIV) 0.25 ml IM x 1
781552|NCT01467882|B1|Baseline|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781553|NCT01467882|P1|Participant Flow|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781554|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781555|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781556|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781557|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781558|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781559|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781560|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781561|NCT01467882|O1|Outcome|AOC Subset|All children in AOC subset who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781562|NCT01467882|O3|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781563|NCT01467882|O2|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781564|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781565|NCT01467882|O1|Outcome|Boys|All boys enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781566|NCT01467882|O1|Outcome|Girls|All girls enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781567|NCT01467882|O2|Outcome|All Children Follicle Stimulating Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781568|NCT01467882|O1|Outcome|All Children Luteinizing Hormone|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781569|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781570|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781571|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781572|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781573|NCT01467882|O1|Outcome|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781574|NCT01467882|E1|Reported Event|Children|All children enrolled who received triptorelin 22.5 mg, intramuscular (IM), at Day 1 and Day 169
781575|NCT01467713|B5|Baseline|Total|Total of all reporting groups
781576|NCT01467713|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781577|NCT01467713|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781578|NCT01467713|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781579|NCT01467713|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781580|NCT01467713|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781581|NCT01467713|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781582|NCT01467713|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781583|NCT01467713|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781584|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781585|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781586|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781587|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781588|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781589|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
783411|NCT01461733|E2|Reported Event|Placebo|Placebo: placebo delivered blinded
781590|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781591|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781592|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781593|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781594|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781595|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781596|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781597|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781598|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781599|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781600|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781601|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781602|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781603|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781604|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781605|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781606|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781607|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781608|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781609|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781610|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781611|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781612|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781613|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781614|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781615|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781616|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781617|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781618|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781619|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781620|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781621|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781622|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781623|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781624|NCT01467713|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781625|NCT01467713|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781626|NCT01467713|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781627|NCT01467713|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781628|NCT01467713|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781629|NCT01467713|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781630|NCT01467713|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, sublingual, once daily, every night at bedtime for up to 9 months.
781631|NCT01467713|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 9 months.
781632|NCT01467700|B5|Baseline|Total|Total of all reporting groups
781633|NCT01467700|B4|Baseline|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781634|NCT01467700|B3|Baseline|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781635|NCT01467700|B2|Baseline|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781636|NCT01467700|B1|Baseline|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781637|NCT01467700|P4|Participant Flow|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781638|NCT01467700|P3|Participant Flow|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781639|NCT01467700|P2|Participant Flow|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781640|NCT01467700|P1|Participant Flow|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781641|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781642|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781643|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781644|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781645|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781646|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781647|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781648|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781649|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781650|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781651|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781652|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781653|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781654|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781655|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781656|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781657|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781658|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781659|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781660|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781661|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781662|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781663|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781664|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781665|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781666|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781667|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781668|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781669|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781670|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781671|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781672|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781673|NCT01467700|O4|Outcome|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781674|NCT01467700|O3|Outcome|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks,
781675|NCT01467700|O2|Outcome|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
781676|NCT01467700|O1|Outcome|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
781677|NCT01467700|E4|Reported Event|Ramelteon SL 0.8 mg|Ramelteon SL 0.8 mg tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781678|NCT01467700|E3|Reported Event|Ramelteon SL 0.4 mg|Ramelteon SL 0.4 mg, tablets, SL, once daily, every night at bedtime for up to 8 weeks.
781679|NCT01467700|E2|Reported Event|Ramelteon SL 0.1 mg|Ramelteon SL 0.1 mg, tablets, SL, once daily (QD), every night at bedtime for up to 8 weeks.
814971|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
781680|NCT01467700|E1|Reported Event|Placebo|Ramelteon SL placebo-matching, tablets, sublingual (SL) [dissolved under the tongue], once daily, every night at bedtime for up to 8 weeks.
782867|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
781681|NCT01467661|B1|Baseline|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781682|NCT01467661|P1|Participant Flow|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781683|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781684|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781685|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781686|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781687|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781688|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781689|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781690|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781691|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781692|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781693|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781694|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 mg per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781695|NCT01467661|O1|Outcome|SPD422 (Anagrelide Hydrochloride)|Participants received anagrelide hydrochloride (SPD422) tablet orally at a dose of 1.0 milligram (mg) per day and titrated as necessary with a maximum single dose of 2.5 mg, total daily dose not more than 10 mg and total dosage increment should not exceed 0.5 mg per day in any week of treatment.
781696|NCT01467661|E2|Reported Event|SPD422: Post-marketing Trial Safety Analysis Set|Included all subjects in the safety analysis set who continued into the post-marketing part of study SPD422-309 (NCT01467661).
781697|NCT01467661|E1|Reported Event|SPD422: Safety Analysis Set|Included all enrolled participants who had taken at least 1 dose of SPD422 since enrolment into Study SPD422-308 (NCT01214915).
781698|NCT01467583|B4|Baseline|Total|Total of all reporting groups
781699|NCT01467583|B3|Baseline|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
781700|NCT01467583|B2|Baseline|Renal Failure, on CRRT|Fondaparinux: 2.5 mg every 48 hours
781701|NCT01467583|B1|Baseline|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
781702|NCT01467583|P3|Participant Flow|Renal Failure, Not on Dialysis Fondaparinux: 2.5 mg q48 hr|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
781703|NCT01467583|P2|Participant Flow|Renal Failure, on CRRT on Fondaparinux: 2.5 mg Every 48 Hours|These are renal failure patients, either acute or chronic on Fondaparinux: 2.5 mg every 48 hours
781704|NCT01467583|P1|Participant Flow|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
781705|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
782787|NCT01463878|E2|Reported Event|Control - Jevity|The control arm of the study. Patients to receive Jevity
781706|NCT01467583|O2|Outcome|Renal Failure-renal Replacement Therapy|"These are patients with renal failure, either acute or chronic, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
781707|NCT01467583|O1|Outcome|Renal Failure on Intermittent Dialysis (IHD)|"These are patients with renal failure, on IHD, receiving fondaparinux 2.5 mg subcutaneously every 48 hours~Fondaparinux: 2.5 mg every 48 hours"
781708|NCT01467583|O3|Outcome|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
781709|NCT01467583|O2|Outcome|Renal Failure-continuous Renal Replacement Therapy|These are renal failure patients, either acute or chronic, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
781710|NCT01467583|O1|Outcome|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
781711|NCT01467583|E3|Reported Event|Renal Failure, Not on Dialysis|"These are patients with acute kidney injury not yet on dialysis~Fondaparinux: 2.5 mg every 48 hours"
781712|NCT01467583|E2|Reported Event|Renal Failure-continuous Renal Replacement Therapy|These are patients with renal failure, on continuous renal replacement therapy (CRRT), receiving Fondaparinux: 2.5 mg every 48 hours
781713|NCT01467583|E1|Reported Event|Renal Failure, on Intermittent Hemodialysis (IHD)|"These are patients with renal failure, on intermittent dialysis~Fondaparinux: 2.5 mg every 48 hours"
781714|NCT01467570|B3|Baseline|Total|Total of all reporting groups
781715|NCT01467570|B2|Baseline|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781716|NCT01467570|B1|Baseline|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781717|NCT01467570|P2|Participant Flow|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781718|NCT01467570|P1|Participant Flow|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781719|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781720|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781721|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781722|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781723|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781724|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781725|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781726|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781727|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781728|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781729|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781730|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781731|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781732|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781733|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781734|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781735|NCT01467570|O2|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781736|NCT01467570|O1|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781737|NCT01467570|O2|Outcome|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200 : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781738|NCT01467570|O1|Outcome|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS : Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781739|NCT01467570|E2|Reported Event|ESPGHAN ORS|"ESPGHAN oral rehydration solution~ESPGHAN ORS: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781740|NCT01467570|E1|Reported Event|Hipp ORS Apple 200|"oral rehydration solution Hipp ORS 200 Apple~oral rehydration solution Hipp ORS Apple 200: Volume of the solution calculated by weight:~fast oral rehydration in 3-4 hours by mouth~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
781741|NCT01467557|B3|Baseline|Total|Total of all reporting groups
781742|NCT01467557|B2|Baseline|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
781743|NCT01467557|B1|Baseline|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
781744|NCT01467557|P2|Participant Flow|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses"
781745|NCT01467557|P1|Participant Flow|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses"
781746|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
781747|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
781748|NCT01467557|O2|Outcome|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
781749|NCT01467557|O1|Outcome|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
781750|NCT01467557|E2|Reported Event|1-Day ACUVUE MOIST Contact Lens Users|"1-Day ACUVUE MOIST contact lens users~etafilcon A daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
781751|NCT01467557|E1|Reported Event|1-Day ACUVUE TruEye Contact Lens Users|"1-Day ACUVUE TruEye contact lens users~narafilcon B daily disposable soft contact lenses: daily disposable soft contact lenses.~Registered Wearers who had been recently fit with these daily disposable lenses."
781752|NCT01467505|B3|Baseline|Total|Total of all reporting groups
781753|NCT01467505|B2|Baseline|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781754|NCT01467505|B1|Baseline|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781755|NCT01467505|P2|Participant Flow|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving cyclosporine (CsA) based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781756|NCT01467505|P1|Participant Flow|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving tacrolimus (TAC) based immunosuppressant regimen at baseline, received telaprevir (T) 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781757|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781986|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781990|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
824050|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
781758|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781759|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781760|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781761|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781762|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781763|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781764|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781765|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781766|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781767|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781768|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781769|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781770|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781771|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781772|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781773|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781774|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781775|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781776|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781777|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781778|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781779|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781780|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781781|NCT01467505|O2|Outcome|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781782|NCT01467505|O1|Outcome|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781783|NCT01467505|E2|Reported Event|T/PR + Immunosuppressant Regimen (Cyclosporine)|Participants who were receiving CsA based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781784|NCT01467505|E1|Reported Event|T/PR + Immunosuppressant Regimen (Tacrolimus)|Participants who were receiving TAC based immunosuppressant regimen at baseline, received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Participants continued their immunosuppressant regimen, as per standard practice and investigator discretion.
781785|NCT01467492|B3|Baseline|Total|Total of all reporting groups
781786|NCT01467492|B2|Baseline|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781787|NCT01467492|B1|Baseline|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781788|NCT01467492|P2|Participant Flow|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781789|NCT01467492|P1|Participant Flow|Group A - Black|Black/African American participants received telaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing <75 kilograms [kg]) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781790|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781791|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781792|NCT01467492|O1|Outcome|All Participants|All enrolled participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781793|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781794|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781795|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781796|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781797|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781798|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781799|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781800|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781801|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781802|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781803|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781804|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781805|NCT01467492|O2|Outcome|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781806|NCT01467492|O1|Outcome|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781807|NCT01467492|E2|Reported Event|Group B – Non-Black|Non-Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781808|NCT01467492|E1|Reported Event|Group A - Black|Black/African American participants received telaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing <75 kg) or 1200 mg/day (for participants weighing >=75 kg) for 24 or 48 weeks.
781809|NCT01467479|B4|Baseline|Total|Total of all reporting groups
781810|NCT01467479|B3|Baseline|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781811|NCT01467479|B2|Baseline|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781812|NCT01467479|B1|Baseline|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781813|NCT01467479|P3|Participant Flow|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving raltegravir (RAL) based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781814|NCT01467479|P2|Participant Flow|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving efavirenz (EFV) based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781815|NCT01467479|P1|Participant Flow|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving atazanavir/ritonavir (ATV/r) based HAART at baseline, received Telaprevir (T)1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (P) (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (R) (RBV) tablet orally twice daily at a dose of 800 milligram per day (mg/day) for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781816|NCT01467479|O1|Outcome|T/PR + HAART Regimen|Participants who were receiving either ATV/r based HAART or EFV based HAART or RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily or 1125 mg three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their respective HAART, as per standard practice and investigator discretion.
781817|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781818|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781819|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781820|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781821|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781987|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
781988|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781822|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781823|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781824|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781825|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781826|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781827|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781828|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781829|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781830|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781831|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781832|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781833|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781834|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781835|NCT01467479|O3|Outcome|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781836|NCT01467479|O2|Outcome|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781955|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781837|NCT01467479|O1|Outcome|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781838|NCT01467479|E3|Reported Event|T/PR + HAART Regimen (RAL-Based)|Participants who were receiving RAL based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781839|NCT01467479|E2|Reported Event|T/PR + HAART Regimen (EFV-Based)|Participants who were receiving EFV based HAART at baseline, received Telaprevir 1125 mg tablet three times a day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781840|NCT01467479|E1|Reported Event|T/PR + HAART Regimen (ATV/r-Based)|Participants who were receiving ATV/r based HAART at baseline, received Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 800 mg/day for 24 or 48 weeks, depending on individual response to telaprevir treatment. Participants continued their HAART, as per standard practice and investigator discretion.
781841|NCT01467076|B4|Baseline|Total|Total of all reporting groups
781842|NCT01467076|B3|Baseline|High Dose IPGE1|300 ng/kg/min
781843|NCT01467076|B2|Baseline|Low Dose IPGE1|150 ng/kg/min
781844|NCT01467076|B1|Baseline|Control|Aerosolized saline
781845|NCT01467076|P3|Participant Flow|High Dose IPGE1|300 ng/kg/min
781846|NCT01467076|P2|Participant Flow|Low Dose IPGE1|150 ng/kg/min
781847|NCT01467076|P1|Participant Flow|Control|Aerosolized saline
781848|NCT01467076|O3|Outcome|High Dose IPGE1|300 ng/kg/min
781849|NCT01467076|O2|Outcome|Low Dose IPGE1|150 ng/kg/min
781850|NCT01467076|O1|Outcome|Control|Aerosolized saline
781851|NCT01467076|E3|Reported Event|High Dose IPGE1|300 ng/kg/min
781852|NCT01467076|E2|Reported Event|Low Dose IPGE1|150 ng/kg/min
781853|NCT01467076|E1|Reported Event|Control|Aerosolized saline
781854|NCT01467037|B3|Baseline|Total|Total of all reporting groups
781855|NCT01467037|B2|Baseline|Rotavirus -Positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus-positives were confirmed via real-time reverse-transcriptase polymerase chain reactions (RT-PCR). RT-PCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
781856|NCT01467037|B1|Baseline|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
781857|NCT01467037|P1|Participant Flow|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
781858|NCT01467037|O2|Outcome|≥1 Versus 0 Dose|We compared Rotavirus VE between patients that received 1 versus 0 dose of RV1.
781859|NCT01467037|O1|Outcome|2 Versus 0 Doses|We compared Rotavirus VE between patients that received 2 versus 0 doses of RV1.
781860|NCT01467037|O2|Outcome|Rotavirus-positive|All stool were initially tested for rotavirus via enzyme immunoassay. Rotavirus positives were confirmed via realtime reversetranscriptase polymerase chain reactions (RTPCR). RTPCR results were used in the event of discordant EIA results. Rotavirus genotyping was performed.
781861|NCT01467037|O1|Outcome|Rotavirus-negative|All stool samples were initially tested for rotavirus via enzyme immunoassay. Patients with a negative result are included in this group.
781862|NCT01467037|E1|Reported Event|Vaccine Effectiveness Study Population|Among patients eligible for active surveillance of acute gastroenteritis, patients aged <15 months at RV1 program implementation (November 1, 2011), AND aged ≥16 weeks at symptom onset
781863|NCT01466881|B1|Baseline|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
781864|NCT01466881|P1|Participant Flow|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
781865|NCT01466881|O2|Outcome|Responders|Eligible Patients who received protocol treatment and achieved complete or partial response.
781866|NCT01466881|O1|Outcome|Non-responders|Eligible patients who received protocol treatment and did not respond to the protocol treatment. Patients for whom response assessment was inadequate were considered non-responders.
781867|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
781868|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
781869|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
781870|NCT01466881|O1|Outcome|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
781871|NCT01466881|E1|Reported Event|MLN8237|Patients receive MLN8237 (alisertib) PO BID on days 1-7. Treatment repeats every 21 days for 17 courses in the absence of disease progression or unacceptable toxicity
781872|NCT01466790|B9|Baseline|Total|Total of all reporting groups
781873|NCT01466790|B8|Baseline|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781981|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
781989|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
781874|NCT01466790|B7|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781875|NCT01466790|B6|Baseline|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781876|NCT01466790|B5|Baseline|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781877|NCT01466790|B4|Baseline|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781878|NCT01466790|B3|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781879|NCT01466790|B2|Baseline|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781880|NCT01466790|B1|Baseline|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781881|NCT01466790|P8|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781882|NCT01466790|P7|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781883|NCT01466790|P6|Participant Flow|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781884|NCT01466790|P5|Participant Flow|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781885|NCT01466790|P4|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781886|NCT01466790|P3|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781887|NCT01466790|P2|Participant Flow|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781888|NCT01466790|P1|Participant Flow|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781889|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781890|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781891|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781892|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781893|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781982|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781894|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781895|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781896|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781897|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781898|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781899|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781900|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781901|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781902|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781903|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781904|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781905|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781906|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781907|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781908|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781909|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781910|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781911|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781912|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781913|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781983|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782788|NCT01463878|E1|Reported Event|Glycerna|Diabetic specific formula
781914|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781915|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781916|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781917|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781918|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781919|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781920|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781921|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781922|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781923|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781924|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781925|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781926|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781927|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781928|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781929|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781930|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781931|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781932|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781933|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781984|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781934|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781935|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781936|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781937|NCT01466790|O8|Outcome|Cohort 2: TMC435 and PSI-7977 for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781938|NCT01466790|O7|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781939|NCT01466790|O6|Outcome|Cohort 2: TMC435 and PSI-7977 for 24 Weeks|Cohort 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781940|NCT01466790|O5|Outcome|Cohort 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 2 participants (with advanced hepatic fibrosis, who did not respond to previous PegIFN/ribavirin therapy or who never received treatment for HCV infection) received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781941|NCT01466790|O4|Outcome|Cohort 1: TMC435 and PSI-7977 for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781942|NCT01466790|O3|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781943|NCT01466790|O2|Outcome|Cohort 1: TMC435 and PSI-7977 for 24 Weeks|Cohort 1 participants received TMC435 150 mg capsule along with PSI-7977 (GS7977) 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781944|NCT01466790|O1|Outcome|Cohort 1: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohort 1 participants (without advanced hepatic fibrosis, who did not respond to previous pegylated interferon [PegIFN]/ribavirin therapy) received TMC435 150 milligram (mg) capsule along with PSI-7977 (GS7977) 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kilogram [kg] and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781945|NCT01466790|E4|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 12 weeks followed by a 36-week follow-up phase.
781946|NCT01466790|E3|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 12 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 12 weeks followed by a 36-week follow-up phase.
781947|NCT01466790|E2|Reported Event|Cohort 1 and 2: TMC435 and PSI-7977 for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet orally once daily for 24 weeks followed by a 24-week follow-up phase.
781948|NCT01466790|E1|Reported Event|Cohort 1 and 2: TMC435, PSI-7977 and Ribavirin for 24 Weeks|Cohorts 1 and 2 participants received TMC435 150 mg capsule along with PSI-7977 400 mg tablet and ribavirin 1000-1200 mg tablet (1000 mg for participants with body weight less than 75 kg and 1200 mg for participants with body weight more than or equal to 75 kg) orally once daily for 24 weeks followed by a 24-week follow-up phase.
781949|NCT01466673|B3|Baseline|Total|Total of all reporting groups
781950|NCT01466673|B2|Baseline|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781951|NCT01466673|B1|Baseline|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781952|NCT01466673|P2|Participant Flow|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781953|NCT01466673|P1|Participant Flow|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781954|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781985|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782789|NCT01463696|B9|Baseline|Total|Total of all reporting groups
781956|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781957|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781958|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781959|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781960|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781961|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781962|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781963|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781964|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781965|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781966|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781967|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781968|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781969|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781970|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781971|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781972|NCT01466673|O2|Outcome|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781973|NCT01466673|O1|Outcome|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781974|NCT01466673|E2|Reported Event|Ethinyl Estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation was administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
781975|NCT01466673|E1|Reported Event|Ethinyl Estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet was administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
781976|NCT01466595|B3|Baseline|Total|Total of all reporting groups
781977|NCT01466595|B2|Baseline|Arm B: No Study Treatment|No study treatment for 4 weeks
781978|NCT01466595|B1|Baseline|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781979|NCT01466595|P2|Participant Flow|Arm B: No Study Treatment|No study treatment for 4 weeks
781980|NCT01466595|P1|Participant Flow|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781992|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781993|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
781994|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781995|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
781996|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781997|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
781998|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
781999|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782000|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782001|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782002|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782003|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782004|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782005|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782006|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782007|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782008|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782009|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782010|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782011|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782012|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782013|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782014|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782015|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782016|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782017|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782018|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782019|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782020|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782021|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782022|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782023|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782024|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782025|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782026|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782027|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782028|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782029|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782030|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782031|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782032|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782033|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782034|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782035|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782036|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782037|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782038|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782039|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782863|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782040|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782041|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782042|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782043|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782044|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782045|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782046|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782047|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782048|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782049|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782050|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782051|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782052|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782053|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782054|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782055|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782056|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782057|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782058|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782059|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782060|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782061|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782062|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782063|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782064|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782065|NCT01466595|O2|Outcome|Arm B: No Study Treatment|No study treatment for 4 weeks
782066|NCT01466595|O1|Outcome|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782067|NCT01466595|E2|Reported Event|Arm B: No Study Treatment|No study treatment for 4 weeks
782068|NCT01466595|E1|Reported Event|Arm A: Treatment With Rifaximin|Participants were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
782069|NCT01466387|B7|Baseline|Total|Total of all reporting groups
782070|NCT01466387|B6|Baseline|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
782071|NCT01466387|B5|Baseline|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
782072|NCT01466387|B4|Baseline|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782073|NCT01466387|B3|Baseline|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
782074|NCT01466387|B2|Baseline|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782075|NCT01466387|B1|Baseline|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
782076|NCT01466387|P6|Participant Flow|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
782077|NCT01466387|P5|Participant Flow|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
782078|NCT01466387|P4|Participant Flow|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782079|NCT01466387|P3|Participant Flow|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
782080|NCT01466387|P2|Participant Flow|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782081|NCT01466387|P1|Participant Flow|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
782082|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
782083|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782084|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 yars of age who received three doses of Rabies vaccine.
782085|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
782086|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782087|NCT01466387|O3|Outcome|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine
782088|NCT01466387|O2|Outcome|JE + Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of rabies vaccine.
782089|NCT01466387|O1|Outcome|JE + Rabies + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782090|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
782091|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782092|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
782093|NCT01466387|O1|Outcome|JE + Rab + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782094|NCT01466387|O2|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
782095|NCT01466387|O1|Outcome|TF + YF + MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782096|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782097|NCT01466387|O1|Outcome|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
782098|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
782099|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
782100|NCT01466387|O2|Outcome|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782101|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
782102|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782103|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
782104|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
782105|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
782106|NCT01466387|O2|Outcome|JE+Rab+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine and one dose of Meningococcal conjugate vaccine.
782107|NCT01466387|O1|Outcome|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese Encephalitis and three doses of Rabies vaccine.
782108|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782109|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
782110|NCT01466387|O2|Outcome|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782111|NCT01466387|O1|Outcome|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
782112|NCT01466387|E6|Reported Event|MenACWY-CRM197 (Combined)|Subjects ≥18 years to ≤60 years of age who received one dose of meningococcal ACWY conjugate vaccine.
782113|NCT01466387|E5|Reported Event|Rabies|Subjects ≥18 years to ≤60 years of age who received three doses of Rabies vaccine.
782114|NCT01466387|E4|Reported Event|JE+Rabies+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies and one dose of meningococcal ACWY conjugate vaccine.
782115|NCT01466387|E3|Reported Event|JE+Rabies|Subjects ≥18 years to ≤60 years of age who received two doses of Japanese encephalitis and three doses of Rabies vaccine.
782116|NCT01466387|E2|Reported Event|TF+YF+MenACWY-CRM197|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide, yellow fever and meningococcal ACWY conjugate vaccine.
782117|NCT01466387|E1|Reported Event|TF+YF|Subjects ≥18 years to ≤60 years of age who received one dose of typhoid Vi polysaccharide and yellow fever vaccine.
782118|NCT01466361|B5|Baseline|Total|Total of all reporting groups
782119|NCT01466361|B4|Baseline|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782120|NCT01466361|B3|Baseline|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
782121|NCT01466361|B2|Baseline|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782122|NCT01466361|B1|Baseline|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
782123|NCT01466361|P4|Participant Flow|Placebo Lozenge (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782124|NCT01466361|P3|Participant Flow|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
782868|NCT01463683|O1|Outcome|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782125|NCT01466361|P2|Participant Flow|Placebo Lozenge (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782126|NCT01466361|P1|Participant Flow|Nicotine Lozenge 4 Milligrams (mg) (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
782127|NCT01466361|O4|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782128|NCT01466361|O3|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
782129|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782130|NCT01466361|O1|Outcome|Nicotine Lozenge 4 mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
782131|NCT01466361|O2|Outcome|Heavy Smokers Group|Participants smoking more than 20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
782132|NCT01466361|O1|Outcome|Light Smokers Group|Participants smoking between 6-20 cigarettes per day at baseline and responded to nicotine craving provocative paradigm before treatment
782133|NCT01466361|O2|Outcome|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782134|NCT01466361|O1|Outcome|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
782135|NCT01466361|O2|Outcome|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of placebo lozenge, through oral route.
782136|NCT01466361|O1|Outcome|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes/day, received a single dose of 1.5mg nicotine lozenge, through oral route.
782137|NCT01466361|E4|Reported Event|Placebo Lozenge 2 (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782138|NCT01466361|E3|Reported Event|Placebo Lozenge 1 (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of placebo lozenge, through oral route.
782139|NCT01466361|E2|Reported Event|Nicotine Lozenge 4mg (Heavy Smokers Group)|Participants smoking more than 20 cigarettes per day, received a single dose of 4mg nicotine lozenge, through oral route.
782140|NCT01466361|E1|Reported Event|Nicotine Lozenge 1.5mg (Light Smokers Group)|Participants smoking between 6-20 cigarettes per day, received a single dose of 1.5mg nicotine lozenge, through oral route.
782141|NCT01466348|B1|Baseline|All Randomized Participants|All randomized participants were evaluated for baseline measures.
782142|NCT01466348|P2|Participant Flow|Paracetamol Powder Then Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of paracetamol soluble powder (1000 mg), then 200 mL solution of two soluble tablets [each tablet containing 500 mg paracetamol and 65 mg of caffeine]. A washout period of 5 hours was maintained.
782143|NCT01466348|P1|Participant Flow|Paracetamol/ Caffeine Tablet Then Paracetamol Powder|Participants were orally administered with 200 millilitre (mL) solution of two soluble tablets, [each tablet containing 500 milligram (mg) paracetamol and 65 mg of caffeine], then 200 mL solution of paracetamol soluble powder (1000 mg). A washout period of 5 hours was maintained.
782144|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782145|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782146|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782147|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782148|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782149|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
782150|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782151|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782152|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782153|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782154|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782155|NCT01466348|O1|Outcome|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782156|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782157|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782158|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782159|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782160|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782161|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782162|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782163|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine
782164|NCT01466348|O2|Outcome|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782165|NCT01466348|O1|Outcome|Paracetamol/ Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782166|NCT01466348|E2|Reported Event|Paracetamol Powder|Participants were orally administered with 200 mL solution of 1000 mg paracetamol soluble powder.
782167|NCT01466348|E1|Reported Event|Paracetamol/Caffeine Tablet|Participants were orally administered with 200 mL solution of two soluble tablets, each tablet containing 500 mg paracetamol and 65 mg of caffeine.
782168|NCT01466270|B3|Baseline|Total|Total of all reporting groups
782169|NCT01466270|B2|Baseline|Arm II - Placebo|Patients receive placebo PO QD.
782170|NCT01466270|B1|Baseline|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
782171|NCT01466270|P2|Participant Flow|Arm II - Placebo|Patients receive placebo PO QD.
782172|NCT01466270|P1|Participant Flow|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
782173|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
782174|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
782175|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
782176|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
782177|NCT01466270|O2|Outcome|Arm II - Placebo|Patients receive placebo PO QD.
782178|NCT01466270|O1|Outcome|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
782179|NCT01466270|O2|Outcome|Arm II|"Patients receive placebo PO QD.~Placebo: Given PO"
782180|NCT01466270|O1|Outcome|Arm I|"Patients receive donepezil hydrochloride PO QD.~donepezil hydrochloride: Given PO"
782181|NCT01466270|E2|Reported Event|Arm II - Placebo|Patients receive placebo PO QD.
782182|NCT01466270|E1|Reported Event|Arm I - Donepezil|Patients receive donepezil hydrochloride PO QD.
782183|NCT01466192|B1|Baseline|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
782184|NCT01466192|P1|Participant Flow|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
782185|NCT01466192|O1|Outcome|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
782186|NCT01466192|E1|Reported Event|MP-424|"MP-424 (generic name:Telaprevir): 750mg q8h for 12 weeks~Ribavirin: 400 - 1000 mg/day based on body weight for 24 weeks~Peginterferon alfa-2b: 1.5mcg/kg/week for 24 weeks"
782187|NCT01466179|B1|Baseline|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782188|NCT01466179|P1|Participant Flow|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782189|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782190|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782191|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782192|NCT01466179|O3|Outcome|Cycle 2: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 2.
782193|NCT01466179|O2|Outcome|Cycle 1: Blinatumomab 28 μg/Day|Participants receiving 28 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
782194|NCT01466179|O1|Outcome|Cycle 1: Blinatumomab 9 μg/Day|Participants receiving 9 μg/day blinatumomab by continuous intravenous (CIV) infusion during Cycle 1.
782195|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782196|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782197|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782284|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782286|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782198|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782199|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782200|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782201|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782202|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782203|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782204|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782205|NCT01466179|O1|Outcome|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782206|NCT01466179|E1|Reported Event|Blinatumomab|Participants received blinatumomab by continuous intravenous (CIV) infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The the initial dose was 9 μg/day for the first seven days of treatment, escalated to 28 μg/day starting from Week 2 of treatment.
782207|NCT01466153|B4|Baseline|TOTAL|Total of all reporting groups
782208|NCT01466153|B3|Baseline|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782209|NCT01466153|B2|Baseline|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782210|NCT01466153|B1|Baseline|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782211|NCT01466153|P3|Participant Flow|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782212|NCT01466153|P2|Participant Flow|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782213|NCT01466153|P1|Participant Flow|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782214|NCT01466153|O2|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782215|NCT01466153|O1|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782216|NCT01466153|O2|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782217|NCT01466153|O1|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782218|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
785720|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
782219|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782220|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782221|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782222|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782223|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782224|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782225|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782226|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782227|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782228|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782229|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782230|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782231|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782232|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782233|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782234|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782235|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782236|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782237|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782285|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782238|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782239|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782240|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782241|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782242|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782243|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782244|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782245|NCT01466153|O3|Outcome|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782246|NCT01466153|O2|Outcome|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782247|NCT01466153|O1|Outcome|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782248|NCT01466153|E3|Reported Event|MEDI-551 4 mg/kg + Bendamustine|MEDI-551 4 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782249|NCT01466153|E2|Reported Event|MEDI-551 2 mg/kg + Bendamustine|MEDI-551 2 mg/kg was administered by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of MEDI-551 in each cycle.
782250|NCT01466153|E1|Reported Event|Rituximab + Bendamustine|Rituximab was administered by IV infusion as 375 mg/m^2 on Day 2 of Cycle 1 and then 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycle. Bendamustine was also administered by IV infusion on Day 1 and Day 2 of every cycle (total 6 cycles). Bendamustine was administered before the administration of rituximab in each cycle.
782251|NCT01466127|B3|Baseline|Total|Total of all reporting groups
782252|NCT01466127|B2|Baseline|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
782253|NCT01466127|B1|Baseline|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
782254|NCT01466127|P2|Participant Flow|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
782255|NCT01466127|P1|Participant Flow|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
782256|NCT01466127|O2|Outcome|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
782257|NCT01466127|O1|Outcome|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
782258|NCT01466127|E2|Reported Event|Oxytocin|"Liquid intranasal oxytocin administered in a nasal spray.~Oxytocin: Liquid metered-dose nasal spray, 30 IUs, administered once."
782259|NCT01466127|E1|Reported Event|Placebo|"Matched nasal spray placebo.~Placebo: Matched nasal spray placebo"
782260|NCT01466075|B1|Baseline|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
782261|NCT01466075|P1|Participant Flow|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
782262|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
782263|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
782264|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
782265|NCT01466075|O1|Outcome|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
782266|NCT01466075|E1|Reported Event|Intended Users of the Monitoring System|"Untrained subjects with diabetes use the Apollo Evolution Investigational Blood Glucose Monitoring System.~Apollo Evolution Investigational BG Monitoring System : Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood. All BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback."
782267|NCT01466062|B1|Baseline|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782268|NCT01466062|P1|Participant Flow|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782269|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782270|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782271|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782272|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782273|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782274|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782275|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782276|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782277|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782278|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782279|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782280|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782281|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782282|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782283|NCT01466062|O1|Outcome|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782355|NCT01465763|B4|Baseline|Total|Total of all reporting groups
785721|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
782287|NCT01466062|E1|Reported Event|Palivizumab|15 mg/kg at 30-day intervals; at least 4 intramuscular injections up to a maximum of 7 intramuscular injections as appropriate for prophylaxis of respiratory syncytial virus (RSV) during the RSV season.
782288|NCT01465958|B1|Baseline|Safety Population|The safety population consisted of all subjects who received any amount of GAMUNEX-C. In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks. In the SC Phase, subjects received weekly subcutaneous infusion of Gamunex-C at a mg/kg dose based on intravenous dose of the subject and dosing interval x 1.37 conversion factor for 12 weeks.
782289|NCT01465958|P2|Participant Flow|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose of subject and dosing interval x 1.37 conversion factor for 12 weeks.
782290|NCT01465958|P1|Participant Flow|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
782291|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
782292|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: Two intravenous infusions at a dose of 200-600 mg/kg per intravenous infusion every 3-4 weeks for 4 to 5 weeks.
782293|NCT01465958|O2|Outcome|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
782294|NCT01465958|O1|Outcome|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: In the IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
782295|NCT01465958|E2|Reported Event|Subcutaneous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on intravenous dose and dosing interval x 1.37 conversion factor for 12 weeks.
782296|NCT01465958|E1|Reported Event|Intravenous GAMUNEX-C|GAMUNEX-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified: In the Run-in Phase, subjects received intravenous infusions of Gamunex-C at a dose between 200 to 600 mg/kg every three or four weeks for 3 months. In the subsequent IV phase, subjects received two IV infusions of Gamunex-C at a dose between 200 to 600 mg/kg for four to five weeks.
782297|NCT01465802|B6|Baseline|Total|Total of all reporting groups
782298|NCT01465802|B5|Baseline|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782299|NCT01465802|B4|Baseline|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782300|NCT01465802|B3|Baseline|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782301|NCT01465802|B2|Baseline|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782302|NCT01465802|B1|Baseline|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782303|NCT01465802|P5|Participant Flow|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782304|NCT01465802|P4|Participant Flow|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782356|NCT01465763|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782357|NCT01465763|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782361|NCT01465763|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782305|NCT01465802|P3|Participant Flow|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05 percent (%) applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782306|NCT01465802|P2|Participant Flow|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782307|NCT01465802|P1|Participant Flow|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 milligram (mg) tablets orally (PO) taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782308|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782309|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782310|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782311|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782312|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782313|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782314|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782315|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782316|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782317|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782318|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782319|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782320|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782321|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782358|NCT01465763|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782864|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
782322|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782323|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782324|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782325|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782326|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782327|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782328|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782329|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782330|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782331|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782332|NCT01465802|O1|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782333|NCT01465802|O5|Outcome|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782334|NCT01465802|O4|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782335|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782336|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782337|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782338|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782359|NCT01465763|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782360|NCT01465763|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782339|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782340|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782341|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782342|NCT01465802|O1|Outcome|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782343|NCT01465802|O3|Outcome|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782344|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782345|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782346|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782347|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782348|NCT01465802|O2|Outcome|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782349|NCT01465802|O1|Outcome|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782350|NCT01465802|E5|Reported Event|Cohort III (Dacomitinib 45 mg)|Open-label dacomitinib 45 mg tablets PO, taken once daily Cycle 1 Day 1 through and including Cycle 1 Day 10; no dacomitinib was taken on Cycle 1 Days 11, 12, 13 and 14; resumption of dacomitinib 45 mg PO once daily taken continuously from Cycle 1 Day 15 onwards until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal.
782351|NCT01465802|E4|Reported Event|Cohort II (Dacomitinib 45mg + VSL#3 Probiotic + Alclometasone)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label VSL#3 probiotic 4 capsules PO taken once daily or 1 sachet PO taken once daily starting on either Days -7, -6, -5 or -4 per site/participant preference, and continuing through Cycle 1 Day 28 (for a total of up to 5 weeks [range of 32 to 35 days]) PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782352|NCT01465802|E3|Reported Event|Cohort I: Arm C (Dacomitinib 45mg+Alclometasone Diproprionate)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS open-label topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks (prophylactic treatment).
782353|NCT01465802|E2|Reported Event|Cohort I: Arm B (Dacomitinib 45 mg + Doxycycline 100 mg)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline 100 mg capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782354|NCT01465802|E1|Reported Event|Cohort I: Arm A (Dacomitinib 45 mg + Doxycycline Placebo)|Open-label dacomitinib 45 mg tablets PO taken once daily until progression of disease, intolerance to dacomitinib treatment, or participant withdrawal PLUS single-blind (participant blinded) doxycycline placebo capsules PO taken twice daily for 4 weeks (prophylactic treatment).
782362|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782363|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782364|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782365|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782366|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782367|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782368|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782369|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782370|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782371|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782372|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782373|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782374|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782375|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782376|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782377|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782378|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782379|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782380|NCT01465763|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782381|NCT01465763|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782382|NCT01465763|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
782383|NCT01465763|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782384|NCT01465763|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg, tablets, orally, BID for 9 weeks of double blind treatment period.
782385|NCT01465412|B5|Baseline|Total|Total of all reporting groups
782386|NCT01465412|B4|Baseline|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782387|NCT01465412|B3|Baseline|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782388|NCT01465412|B2|Baseline|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782389|NCT01465412|B1|Baseline|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782390|NCT01465412|P4|Participant Flow|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782391|NCT01465412|P3|Participant Flow|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782392|NCT01465412|P2|Participant Flow|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782393|NCT01465412|P1|Participant Flow|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782394|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782395|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782396|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782397|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782398|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782399|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782400|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782401|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782402|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782403|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782404|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782405|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782406|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782407|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782408|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782409|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782410|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782411|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782412|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782413|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782414|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782415|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782416|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782417|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782418|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782419|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782420|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782421|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782422|NCT01465412|O4|Outcome|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782423|NCT01465412|O3|Outcome|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782424|NCT01465412|O2|Outcome|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782425|NCT01465412|O1|Outcome|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782426|NCT01465412|E4|Reported Event|Healthy to Match Moderate HI Part 2|Healthy volunteers with normal hepatic function matched to participants with moderate chronic liver disease by race, age, BMI, and gender, enrolled in Part 2 received one 5-mg preladenant tablet, orally, on Day 1.
782427|NCT01465412|E3|Reported Event|Moderate HI Part 2|Participants with moderate chronic liver disease enrolled in Part 2 one 5-mg preladenant tablet, orally, on Day 1.
782428|NCT01465412|E2|Reported Event|Healthy to Match Mild HI Part 1|Healthy volunteers with normal hepatic function matched to participants with mild chronic liver disease by race, age, BMI, and gender, enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782429|NCT01465412|E1|Reported Event|Mild Hepatic Impaired (HI) Part 1|Participants with mild chronic liver disease enrolled in Part 1 received one 5-mg preladenant tablet, orally, on Day 1.
782510|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
782511|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
782430|NCT01465386|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
782431|NCT01465386|P1|Participant Flow|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
782432|NCT01465386|O1|Outcome|Treated Patients|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
782433|NCT01465386|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive bortezomib SC on days 1, 8, 15 and 22. Treatment repeats every 35 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~bortezomib: Given SC"
782434|NCT01465230|B1|Baseline|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
782435|NCT01465230|P1|Participant Flow|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
782436|NCT01465230|O1|Outcome|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
782437|NCT01465230|E1|Reported Event|Lenalidomide|"Maintenance treatment with lenalidomide following induction treatment with bendamustine and rituximab.~Maintenance lenalidomide: Daily maintenance treatment, oral lenalidomide"
782438|NCT01465178|B3|Baseline|Total|Total of all reporting groups
782439|NCT01465178|B2|Baseline|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
782440|NCT01465178|B1|Baseline|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
782441|NCT01465178|P2|Participant Flow|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
782442|NCT01465178|P1|Participant Flow|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
782443|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
782444|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
782445|NCT01465178|O2|Outcome|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
782446|NCT01465178|O1|Outcome|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
782447|NCT01465178|E2|Reported Event|Placebo|"Non-matching placebo, gelatin filled capsules~Placebo: matching placebo"
782448|NCT01465178|E1|Reported Event|2000 IU Vitamin D3|"Cholecalciferol 2,000 IU capsules~cholecalciferol: 2000 IU cholecalciferol gelcaps by mouth daily"
782449|NCT01465048|B4|Baseline|Total|Total of all reporting groups
782450|NCT01465048|B3|Baseline|PfSPZ Challenge 25,000 IM|
782451|NCT01465048|B2|Baseline|PfSPZ Challenge 2,500 IM|
782452|NCT01465048|B1|Baseline|PfSPZ Challenge 2,500 ID|
782453|NCT01465048|P3|Participant Flow|PfSPZ Challenge 25,000 IM|
782454|NCT01465048|P2|Participant Flow|PfSPZ Challenge 2,500 IM|
782455|NCT01465048|P1|Participant Flow|PfSPZ Challenge 2,500 ID|
782456|NCT01465048|O3|Outcome|PfSPZ Challenge 25,000 IM|
782457|NCT01465048|O2|Outcome|PfSPZ Challenge 2,500 IM|
782458|NCT01465048|O1|Outcome|PfSPZ Challenge 2,500 ID|
782459|NCT01465048|E3|Reported Event|PfSPZ Challenge 25,000 IM|
782460|NCT01465048|E2|Reported Event|PfSPZ Challenge 2,500 IM|
782461|NCT01465048|E1|Reported Event|PfSPZ Challenge 2,500 ID|
782462|NCT01465022|B4|Baseline|Total|Total of all reporting groups
782463|NCT01465022|B3|Baseline|Not Randomized|70 women who were enrolled.
782464|NCT01465022|B2|Baseline|Progestin-only Pill|Study Arm B is one of two interventions (POP).
782465|NCT01465022|B1|Baseline|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions (OCP).
782466|NCT01465022|P3|Participant Flow|Not Randomized|Participants who were consented but not randomized.
782467|NCT01465022|P2|Participant Flow|Progestin-only Pill|Study Arm B is one of two interventions.
782468|NCT01465022|P1|Participant Flow|Combined Estrogen-progestin Pill|Study Arm A is one of two interventions.
782469|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
782470|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
782471|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
782472|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
782473|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
782474|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
782475|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
782476|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
782477|NCT01465022|O2|Outcome|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
782478|NCT01465022|O1|Outcome|Combined Estrogen-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
782479|NCT01465022|E2|Reported Event|Progestin-only Pill|"Study Arm B is one of two interventions (Progestin-only pill)~Progestin-only pill: .35 mg norethindrone once a day orally"
782480|NCT01465022|E1|Reported Event|Combined Estrogin-progestin Pill|"Study Arm A is one of two interventions (Combined estrogen-progestin pill)~Combined estrogen-progestin pill: 1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo"
782481|NCT01464996|B1|Baseline|All Study Participants|Will include composite restorations placed using both dental adhesives OptiBond XTR and OptiBond FL.
782482|NCT01464996|P1|Participant Flow|All Study Participants|"Will include composite restorations placed using both the dental adhesive OptiBond XTR and OptiBond FL.~Participants were randomized to receive either type of intervention"
782483|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782484|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782485|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782486|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782487|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782488|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782489|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782490|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782491|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782492|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782493|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782494|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782495|NCT01464996|O2|Outcome|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782496|NCT01464996|O1|Outcome|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782497|NCT01464996|E2|Reported Event|Adhesive OptiBond FL|"will include composite restorations placed using the dental adhesive OptibOnd FL.~Adhesives: OptiBond FL Composite: Herculite Ultra: Arm 2 (FL) is a 3-step, etch-and-rinse adhesive."
782498|NCT01464996|E1|Reported Event|Adhesive OptiBond XTR|"will include composite restorations placed using the dental adhesive OptiBond XTR.~Adhesives: OptiBond XTR Composite: Herculite Ultra: The intervention in Arm 1 (XTR) is a 2-step, self-etching adhesive."
782499|NCT01464931|B3|Baseline|Total|Total of all reporting groups
782500|NCT01464931|B2|Baseline|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782501|NCT01464931|B1|Baseline|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782502|NCT01464931|P2|Participant Flow|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782503|NCT01464931|P1|Participant Flow|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782504|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782505|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782506|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782507|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782508|NCT01464931|O2|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
782509|NCT01464931|O1|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
782512|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
782513|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
782514|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
782515|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
782516|NCT01464931|O4|Outcome|ESRD - Dose 2|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 29.
782517|NCT01464931|O3|Outcome|Severe CKD - Dose 2|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 29.
782518|NCT01464931|O2|Outcome|ESRD - Dose 1|Participants with ESRD requiring dialysis received 120 mg denosumab administered subcutaneously on Day 1.
782519|NCT01464931|O1|Outcome|Severe CKD - Dose 1|Participants with severe CKD received 120 mg denosumab administered subcutaneously on Day 1.
782520|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782521|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782522|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782523|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782524|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782525|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782526|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782527|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782528|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782529|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782530|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782531|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782532|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782533|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782534|NCT01464931|O2|Outcome|ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782535|NCT01464931|O1|Outcome|Severe CKD|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782536|NCT01464931|E3|Reported Event|Denosumab 120 mg - All Subjects|Participants received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782537|NCT01464931|E2|Reported Event|Denosumab 120 mg - ESRD|Participants with end-stage renal disease (ESRD) requiring dialysis received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782538|NCT01464931|E1|Reported Event|Denosumab 120 mg - Severe|Participants with severe chronic kidney disease (CKD; defined as creatinine clearance < 30 mL/min) received two 120 mg doses of denosumab administered subcutaneously on Day 1 and Day 29.
782539|NCT01464840|B4|Baseline|Total|Total of all reporting groups
782540|NCT01464840|B3|Baseline|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782541|NCT01464840|B2|Baseline|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782542|NCT01464840|B1|Baseline|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782543|NCT01464840|P3|Participant Flow|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782544|NCT01464840|P2|Participant Flow|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782545|NCT01464840|P1|Participant Flow|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782546|NCT01464840|O3|Outcome|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782547|NCT01464840|O2|Outcome|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782639|NCT01464619|B3|Baseline|Total|Total of all reporting groups
814972|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
782669|NCT01464424|E2|Reported Event|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
782548|NCT01464840|O1|Outcome|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782549|NCT01464840|E3|Reported Event|60 Minutes|"500 mg of intravenous azithromycin will be administered 60 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782550|NCT01464840|E2|Reported Event|30 Minutes|"500 mg of intravenous azithromycin will be administered 30 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782551|NCT01464840|E1|Reported Event|15 Minutes|"500 mg of intravenous azithromycin will be administered 15 minutes prior to incision.~Azithromycin : 500 mg intravenous infused over 1 hour"
782552|NCT01464827|B15|Baseline|Total|Total of all reporting groups
782553|NCT01464827|B14|Baseline|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782554|NCT01464827|B13|Baseline|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782555|NCT01464827|B12|Baseline|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782556|NCT01464827|B11|Baseline|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782557|NCT01464827|B10|Baseline|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782558|NCT01464827|B9|Baseline|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782559|NCT01464827|B8|Baseline|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782560|NCT01464827|B7|Baseline|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782561|NCT01464827|B6|Baseline|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782562|NCT01464827|B5|Baseline|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
782563|NCT01464827|B4|Baseline|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782564|NCT01464827|B3|Baseline|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782565|NCT01464827|B2|Baseline|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782566|NCT01464827|B1|Baseline|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
782567|NCT01464827|P14|Participant Flow|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782568|NCT01464827|P13|Participant Flow|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782569|NCT01464827|P12|Participant Flow|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782570|NCT01464827|P11|Participant Flow|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782571|NCT01464827|P10|Participant Flow|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782572|NCT01464827|P9|Participant Flow|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782573|NCT01464827|P8|Participant Flow|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782574|NCT01464827|P7|Participant Flow|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782575|NCT01464827|P6|Participant Flow|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782576|NCT01464827|P5|Participant Flow|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
782577|NCT01464827|P4|Participant Flow|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782668|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
782578|NCT01464827|P3|Participant Flow|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782579|NCT01464827|P2|Participant Flow|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782580|NCT01464827|P1|Participant Flow|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
782581|NCT01464827|O2|Outcome|Groups K + L + M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
782582|NCT01464827|O1|Outcome|Groups F + G + H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 or 24 weeks.
782583|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782584|NCT01464827|O1|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily, for 12 weeks.
782585|NCT01464827|O3|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782586|NCT01464827|O2|Outcome|Groups C + D + J|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782587|NCT01464827|O1|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782588|NCT01464827|O3|Outcome|Groups H + I + M + N|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782589|NCT01464827|O2|Outcome|Groups F + G + K + L|Participants (treatment-naïve and null-responders) received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782590|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
782591|NCT01464827|O14|Outcome|Group N|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782592|NCT01464827|O13|Outcome|Group M|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782593|NCT01464827|O12|Outcome|Group L|Participants who were null-responders to previous HCV treatment received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782594|NCT01464827|O11|Outcome|Group K|Participants who were null-responders to previous HCV treatment received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782595|NCT01464827|O10|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782596|NCT01464827|O9|Outcome|Group I|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782597|NCT01464827|O8|Outcome|Group H|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782598|NCT01464827|O7|Outcome|Group G|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782599|NCT01464827|O6|Outcome|Group F|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782600|NCT01464827|O5|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
782601|NCT01464827|O4|Outcome|Group D|Treatment-naïve participants received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782602|NCT01464827|O3|Outcome|Group C|Treatment-naïve participants received ABT-450 100 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782603|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782604|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 8 weeks.
782605|NCT01464827|O9|Outcome|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782606|NCT01464827|O8|Outcome|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782607|NCT01464827|O7|Outcome|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782608|NCT01464827|O6|Outcome|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782609|NCT01464827|O5|Outcome|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782610|NCT01464827|O4|Outcome|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
782611|NCT01464827|O3|Outcome|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782612|NCT01464827|O2|Outcome|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782613|NCT01464827|O1|Outcome|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
782614|NCT01464827|E9|Reported Event|Group M + N|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782615|NCT01464827|E8|Reported Event|Group K + L|Participants who were null-responders to previous HCV treatment received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782616|NCT01464827|E7|Reported Event|Group J|Participants who were null-responders to previous HCV treatment received ABT-450 200 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782617|NCT01464827|E6|Reported Event|Group H + I|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 24 weeks.
782618|NCT01464827|E5|Reported Event|Group F + G|Treatment-naïve participants received ABT-450 (100 mg or 150 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782619|NCT01464827|E4|Reported Event|Group E|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ABT-333 400 mg twice daily for 12 weeks.
782620|NCT01464827|E3|Reported Event|Group C + D|Treatment-naïve participants received ABT-450 (100 mg or 200 mg) and ritonavir 100 mg once daily, ABT-267 25 mg once daily, and ribavirin dosed by weight, twice daily, for 12 weeks.
782621|NCT01464827|E2|Reported Event|Group B|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily for 12 weeks.
782622|NCT01464827|E1|Reported Event|Group A|Treatment-naïve participants received ABT-450 150 mg and ritonavir 100 mg once daily, ABT-267 25 mg once daily, ABT-333 400 mg twice daily, and ribavirin dosed by weight, twice daily, for 8 weeks.
782623|NCT01464788|B4|Baseline|Total|Total of all reporting groups
782624|NCT01464788|B3|Baseline|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782625|NCT01464788|B2|Baseline|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782626|NCT01464788|B1|Baseline|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782627|NCT01464788|P3|Participant Flow|Rt-PA (Alteplase) Only|Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour.
782628|NCT01464788|P2|Participant Flow|High Dose Argatroban + Rt-PA (Alteplase)|"Argatroban: 100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours.~and~Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
782629|NCT01464788|P1|Participant Flow|Low-dose Argatroban + Rt-PA (Alteplase)|"100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours.~and~Intravenous rt-PA (alteplase) 0.9mg/kg (max dose 90mg); 10% bolus and remaining over 1 hour."
782630|NCT01464788|O3|Outcome|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782631|NCT01464788|O2|Outcome|High Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782632|NCT01464788|O1|Outcome|Low Dose Argatroban + Rt-PA (Alteplase)|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782633|NCT01464788|O3|Outcome|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782634|NCT01464788|O2|Outcome|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782635|NCT01464788|O1|Outcome|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782636|NCT01464788|E3|Reported Event|Rt-PA (Alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782637|NCT01464788|E2|Reported Event|High Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782638|NCT01464788|E1|Reported Event|Low Dose Argatroban + Rt-PA|100 micrograms/kilogram bolus, followed by 1 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
782640|NCT01464619|B2|Baseline|Intervention|"Caregivers assigned to the intervention arm will be assigned to the Incredible Years parenting intervention immediately after enrollment. They will also receive enhanced mental health referrals and monthly follow-up phone calls.~The Incredible Years Parenting Intervention: The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials."
782641|NCT01464619|B1|Baseline|Delayed Intervention|"Those assigned to the delayed intervention arm will receive enhanced mental health referrals, monthly follow-up phone calls, and will be assigned to the parenting intervention 3-4 months after enrollment.~Delayed Intervention: Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment."
782642|NCT01464619|P2|Participant Flow|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782643|NCT01464619|P1|Participant Flow|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782644|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782645|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782646|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782647|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782648|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782649|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782650|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782651|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782652|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
782653|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
782654|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782655|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782656|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
782657|NCT01464619|O1|Outcome|Intervention|Subjects received parenting intervention immediately
782658|NCT01464619|O2|Outcome|Delayed Intervention|Subjects received an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions, following the second study visit. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782659|NCT01464619|O1|Outcome|Intervention|Subjects received immediately an adaptation of the Incredible Years Toddler Basic parenting intervention, which consisted of 12 weekly 2 hour sessions. Sessions were adapted for depressed parents with infusion of depression psychoeducational materials.
782660|NCT01464619|E2|Reported Event|Delayed Intervention|Subjects received parenting intervention after completing 2 study visits 12 week apart.
782661|NCT01464619|E1|Reported Event|Intervention|Subjects received parenting intervention immediately
782662|NCT01464424|B1|Baseline|Overall|Travoprost 0.004% and bimatoprost 0.01% in cross-over fashion, as randomized, 6 weeks each
782663|NCT01464424|P2|Participant Flow|LUMIGAN, Then TRAVATAN|Bimatoprost 0.01% ophthalmic solution (LUMIGAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by travoprost 0.004% ophthalmic solution (TRAVATAN), same dose, same duration, as randomized, for a total duration of 12 weeks
782664|NCT01464424|P1|Participant Flow|TRAVATAN, Then LUMIGAN|Travoprost 0.004% ophthalmic solution (TRAVATAN), 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks, followed by bimatoprost 0.01% ophthalmic solution (LUMIGAN), same dose, same duration, as randomized, for a total duration of 12 weeks
782665|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
782666|NCT01464424|O1|Outcome|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
782667|NCT01464424|O2|Outcome|LUMIGAN|Bimatoprost 0.01% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
782670|NCT01464424|E1|Reported Event|TRAVATAN|Travoprost 0.004% ophthalmic solution, 1 drop to the study eye once daily every evening at 8:00 pm for 6 weeks
782671|NCT01464359|B1|Baseline|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782672|NCT01464359|P1|Participant Flow|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782673|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782674|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782675|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782676|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782677|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782690|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
782715|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782716|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
814973|NCT01344447|O2|Outcome|Non-contrast MRA|
782717|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782678|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782679|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782680|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782681|NCT01464359|O1|Outcome|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782682|NCT01464359|E1|Reported Event|Patients With Acute Myelogenous Leukemia|"Allopurinol: start on Day -8 per institutional guidelines Fludarabine: give on Days -7, -6 and -5, 25 mg/m^2 intravenously (IV) Cyclophosphamide: give on Days -7 and -6, 60 mg/kg IV along with mesna per institutional guidelines Total body irradiation: give on Days -5, -4, -3, and -2, 165 cGy twice daily Double T-cell depleted umbilical cord blood transplantation with activation of one of the units in interleukin-2 (IL-2): give on Day 0 IL-2: start on Day +3 and Day +60, 9 MU subcutaneously three times weekly for 6 doses~Alternate preparative therapy for patients not able to receive additional radiation~Levetiracetam (Keppra): begin on Day -10 per institutional guidelines Busulfan: give Day -9 through Day -6, 0.8 mg/kg (1.1 mg/kg if <12 kg) IV every 6 hours Cyclophosphamide: give Day -5 through Day -2, 50 mg/kg/day IV along with mesna per institutional guidelines"
782683|NCT01464307|B3|Baseline|Total|Total of all reporting groups
782684|NCT01464307|B2|Baseline|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
782685|NCT01464307|B1|Baseline|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782686|NCT01464307|P2|Participant Flow|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
782687|NCT01464307|P1|Participant Flow|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9 percent (%) Sodium Chloride (NaCl), 400 units, total volume 8.0 milliliter (mL); Mode of administration: intramuscular injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection sessions of solution, prepared by reconstitution of powder with 0.9% NaCl, 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782688|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
782689|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782691|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782692|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
782693|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782694|NCT01464307|O2|Outcome|Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
782695|NCT01464307|O1|Outcome|IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782696|NCT01464307|E3|Reported Event|Open-Label Extension: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Open-Label Extension Period: All subjects receive three injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782697|NCT01464307|E2|Reported Event|Main Period: Placebo|"Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection.~Placebo Comparator: Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection"
782698|NCT01464307|E1|Reported Event|Main Period: IncobotulinumtoxinA (Xeomin) 400 Units|"IncobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kiloDalton), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection.~IncobotulinumtoxinA (400 Units): Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection."
782699|NCT01464255|B3|Baseline|Total|Total of all reporting groups
782700|NCT01464255|B2|Baseline|Ocufilcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
782701|NCT01464255|B1|Baseline|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
782702|NCT01464255|P2|Participant Flow|Ocufulcon B Then Ocufilcon D|Participants were randomized to wear ocufilcon B lenses for 1 week and then crossed over to the ocufilcon D lens pair for 1 week.
782703|NCT01464255|P1|Participant Flow|Ocufilcon D Then Ocufilcon B|Participants were randomized to wear ocufilcon D lenses for 1 week and then crossed over to the ocufilcon B lens pair for 1 week.
782704|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782705|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782706|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782707|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782708|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782709|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782710|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782711|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782712|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782713|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782714|NCT01464255|O1|Outcome|Overall Study Group|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782782|NCT01463878|B1|Baseline|Glycerna|Diabetic specific formula
814974|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
782718|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782719|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782720|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782721|NCT01464255|O2|Outcome|Ocufilcon B Then Ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782722|NCT01464255|O1|Outcome|Ocufilcon D Then Ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
782723|NCT01464255|E2|Reported Event|Ocufilcon B|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782724|NCT01464255|E1|Reported Event|Ocufilcon D|Participants wore (experimental) ocufilcon D lenses or (active comparator) ocufilcon B lens bilaterally in a randomized order for 1 week and then crossed over to the alternate pair for 1 week.
782725|NCT01464229|B3|Baseline|Total|Total of all reporting groups
782726|NCT01464229|B2|Baseline|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
782727|NCT01464229|B1|Baseline|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks, in addition to SSRI antidepressant
782728|NCT01464229|P2|Participant Flow|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks, then iloperidone for 4 weeks; in addition to standard SSRI antidepressant
782729|NCT01464229|P1|Participant Flow|Iloperidone, Then Placebo|Iloperidone (1-8 mg) for 4 weeks, then placebo for 4 weeks; in addition to standard SSRI antidepressant
782730|NCT01464229|O2|Outcome|Placebo, Then Iloperidone|Placebo: Placebo for 4 weeks then iloperidone for 4 weeks; addition to standard SSRI antidepressant
782731|NCT01464229|O1|Outcome|Iloperidone, Then Placebo|Iloperidone: Iloperidone 1-8 mg for 4 weeks then placebo for 4 weeks; addition to SSRI antidepressant
782732|NCT01464229|E2|Reported Event|Placebo|
782733|NCT01464229|E1|Reported Event|Iloperidone|
782734|NCT01464190|B3|Baseline|Total|Total of all reporting groups
782735|NCT01464190|B2|Baseline|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
782736|NCT01464190|B1|Baseline|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
782737|NCT01464190|P2|Participant Flow|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
782738|NCT01464190|P1|Participant Flow|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day)
782739|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
782740|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
782741|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
782742|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
782743|NCT01464190|O2|Outcome|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
782744|NCT01464190|O1|Outcome|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
782745|NCT01464190|E2|Reported Event|Sevelamer Carbonate|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
782746|NCT01464190|E1|Reported Event|PA21|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
782747|NCT01464021|B1|Baseline|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782748|NCT01464021|P1|Participant Flow|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782749|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782750|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782751|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782752|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782753|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782754|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782783|NCT01463878|P2|Participant Flow|Control - Jevity|The control arm of the study. Patients to receive Jevity
782784|NCT01463878|P1|Participant Flow|Glycerna|Diabetic specific formula
782865|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
824054|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
782755|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782756|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782757|NCT01464021|O1|Outcome|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782758|NCT01464021|E1|Reported Event|Adalimumab|Chinese adult participants with a diagnosis of rheumatoid arthritis (RA) (any disease duration) who meet the requirements per the local label for treatment with adalimumab. Participants must be naïve to adalimumab at the Baseline visit.
782759|NCT01463982|B5|Baseline|Total|Total of all reporting groups
782760|NCT01463982|B4|Baseline|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782761|NCT01463982|B3|Baseline|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782762|NCT01463982|B2|Baseline|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782763|NCT01463982|B1|Baseline|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782764|NCT01463982|P4|Participant Flow|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782765|NCT01463982|P3|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782766|NCT01463982|P2|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782767|NCT01463982|P1|Participant Flow|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782768|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782769|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782770|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782771|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782772|NCT01463982|O4|Outcome|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782773|NCT01463982|O3|Outcome|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782774|NCT01463982|O2|Outcome|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782775|NCT01463982|O1|Outcome|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782776|NCT01463982|E4|Reported Event|Capecitabine 1000mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782777|NCT01463982|E3|Reported Event|Capecitabine 800mg/㎡ + Oratecan 20mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782778|NCT01463982|E2|Reported Event|Capecitabine 800mg/㎡ + Oratecan 15mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782779|NCT01463982|E1|Reported Event|Capecitabine 800mg/㎡ + Oratecan 10mg/㎡|One cycle was composed of 3 weeks. Oratecan™ was administered once daily for 5 consecutive days, and Capecitabine Tablet was administered twice daily for 14 consecutive days, followed by washout period for 7 days.
782780|NCT01463878|B3|Baseline|Total|Total of all reporting groups
782781|NCT01463878|B2|Baseline|Control - Jevity|The control arm of the study. Patients to receive Jevity
782790|NCT01463696|B8|Baseline|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782791|NCT01463696|B7|Baseline|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782792|NCT01463696|B6|Baseline|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782793|NCT01463696|B5|Baseline|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782794|NCT01463696|B4|Baseline|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782795|NCT01463696|B3|Baseline|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782796|NCT01463696|B2|Baseline|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782797|NCT01463696|B1|Baseline|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782798|NCT01463696|P8|Participant Flow|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782799|NCT01463696|P7|Participant Flow|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782800|NCT01463696|P6|Participant Flow|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782801|NCT01463696|P5|Participant Flow|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782802|NCT01463696|P4|Participant Flow|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782803|NCT01463696|P3|Participant Flow|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782804|NCT01463696|P2|Participant Flow|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782805|NCT01463696|P1|Participant Flow|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered orally (PO) twice a day (BID) on Days 1-6 and PO once daily (QD) in the morning on Day 7 of the 21-day cycle to accommodate pharmacokinetic (PK) sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782806|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782807|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782808|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782809|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782810|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782811|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782860|NCT01463683|P1|Participant Flow|V232-2XP Subcutaneous (SC)|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782812|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782813|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782814|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782815|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782816|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782817|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782818|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782819|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782820|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782821|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782822|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782823|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782824|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782825|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782826|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782827|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782828|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782829|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782830|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782831|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782832|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782833|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782861|NCT01463683|O3|Outcome|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
782862|NCT01463683|O2|Outcome|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782834|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782835|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782836|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782837|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782838|NCT01463696|O8|Outcome|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782839|NCT01463696|O7|Outcome|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782840|NCT01463696|O6|Outcome|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782841|NCT01463696|O5|Outcome|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782842|NCT01463696|O4|Outcome|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782843|NCT01463696|O3|Outcome|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782844|NCT01463696|O2|Outcome|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782845|NCT01463696|O1|Outcome|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782846|NCT01463696|E8|Reported Event|MK-8242 500 mg BID|In Cycle 1, participants received MK-8242 500 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 500 mg PO BID on Days 1-7 of each 21-day cycle.
782847|NCT01463696|E7|Reported Event|MK-8242 400 mg BID|In Cycle 1, participants received MK-8242 400 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 400 mg PO BID on Days 1-7 of each 21-day cycle.
782848|NCT01463696|E6|Reported Event|MK-8242 350 mg BID|In Cycle 1, participants received MK-8242 350 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 350 mg PO BID on Days 1-7 of each 21-day cycle.
782849|NCT01463696|E5|Reported Event|MK-8242 300 mg BID|In Cycle 1, participants received MK-8242 300 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 300 mg PO BID on Days 1-7 of each 21-day cycle.
782850|NCT01463696|E4|Reported Event|MK-8242 250 mg BID|In Cycle 1, participants received MK-8242 250 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 250 mg PO BID on Days 1-7 of each 21-day cycle.
782851|NCT01463696|E3|Reported Event|MK-8242 170 mg BID|In Cycle 1, participants received MK-8242 170 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 170 mg PO BID on Days 1-7 of each 21-day cycle.
782852|NCT01463696|E2|Reported Event|MK-8242 120 mg BID|In Cycle 1, participants received MK-8242 120 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 120 mg PO BID on Days 1-7 of each 21-day cycle.
782853|NCT01463696|E1|Reported Event|MK-8242 60 mg BID|In Cycle 1, participants received MK-8242 60 mg administered PO BID on Days 1-6 and PO QD in the morning on Day 7 of the 21-day cycle to accommodate PK sampling. In Cycle 2 and subsequent cycles, participants received MK-8242 60 mg PO BID on Days 1-7 of each 21-day cycle.
782854|NCT01463683|B4|Baseline|Total|Total of all reporting groups
782855|NCT01463683|B3|Baseline|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
782856|NCT01463683|B2|Baseline|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782857|NCT01463683|B1|Baseline|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782858|NCT01463683|P3|Participant Flow|V232-2XP Intramuscular (IM)|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
782859|NCT01463683|P2|Participant Flow|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782869|NCT01463683|E3|Reported Event|V232-2XP IM|2XP HEPTAVAX™-II vaccine 0.5 mL intramuscular injection on Day 1, Month 1, and Month 6
782870|NCT01463683|E2|Reported Event|V232-1XP SC|1XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782871|NCT01463683|E1|Reported Event|V232-2XP SC|2XP HEPTAVAX™-II vaccine 0.5 mL subcutaneous injection on Day 1, Month 1, and Month 6
782872|NCT01463527|B3|Baseline|Total|Total of all reporting groups
782873|NCT01463527|B2|Baseline|Capnography Blind|Staff members were blinded to screen on capnography monitor and all alarms turned off for the sedation.
782874|NCT01463527|B1|Baseline|Open Capnography|Staff members able to view capnography monitor during sedation.
782875|NCT01463527|P2|Participant Flow|Capnography Blind|Staff members blinded to capnography screen and alarms turned off during sedation.
782876|NCT01463527|P1|Participant Flow|Open Capnography|Staff members able to view capnography monitor during sedation.
782877|NCT01463527|O2|Outcome|Capnography Blind|Staff blinded to capnography screen and alarms turned off during sedation.
782878|NCT01463527|O1|Outcome|Open Capnography|Staff able to view capnography monitor during sedation.
782879|NCT01463527|E2|Reported Event|Capnography Blind|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
782880|NCT01463527|E1|Reported Event|Open Capnography|Nellcor NPB-70 Capnograph: Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
782881|NCT01463384|B1|Baseline|Minocycline|Subjects administered 50mg minocycline twice daily for 6 months
782882|NCT01463384|P1|Participant Flow|Minocycline|Subjects were administered 50mg minocycline twice daily for 6 months
782883|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
782884|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
782885|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
782886|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
782887|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
782888|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
782889|NCT01463384|O3|Outcome|Minocycline NC|Normal control subjects who were administered 50mg minocycline twice daily.
782890|NCT01463384|O2|Outcome|Minocycline MCI|Mild cognitively impaired subject who was administered 50mg minocycline twice daily.
782891|NCT01463384|O1|Outcome|Minocycline AD|Alzheimer subjects who were administered 50mg minocycline twice daily.
782892|NCT01463384|E1|Reported Event|Minocycline|No adverse events were reported in any subjects who were taking minocycline. All subjects underwent monthly blood tests to monitor alanine transaminase and blood urea nitrogen levels.
782893|NCT01463293|B4|Baseline|Total|Total of all reporting groups
782894|NCT01463293|B3|Baseline|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
782895|NCT01463293|B2|Baseline|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
782896|NCT01463293|B1|Baseline|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
782897|NCT01463293|P3|Participant Flow|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
782898|NCT01463293|P2|Participant Flow|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
782899|NCT01463293|P1|Participant Flow|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
782900|NCT01463293|O3|Outcome|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
782901|NCT01463293|O2|Outcome|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
782902|NCT01463293|O1|Outcome|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
782903|NCT01463293|E3|Reported Event|Placebo|"Placebo capsule~Placebo: Capsule containing no probiotic once a day"
782904|NCT01463293|E2|Reported Event|Low Dose Probiotic|"Capsule containing 1 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 1 billion cfu B. lactis HN019 once a day"
782905|NCT01463293|E1|Reported Event|High-dose Probiotic|"Capsule containing 10 billion cfu B. lactis HN019~B. lactis HN019: Capsule containing 10 billion cfu B. lactis HN019 once a day"
782906|NCT01463111|B1|Baseline|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782907|NCT01463111|P1|Participant Flow|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782908|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782909|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782910|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782911|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782912|NCT01463111|O1|Outcome|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782913|NCT01463111|E1|Reported Event|Mood Stabilizer|"Participants diagnosed with Bipolar Disorder received open-label treatment with a mood stabilizer for six weeks.~Lithium, valproate, lamotrigine: Open label treatment per standard of care for bipolar disorder for six weeks."
782914|NCT01463033|B3|Baseline|Total|Total of all reporting groups
782915|NCT01463033|B2|Baseline|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
782916|NCT01463033|B1|Baseline|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
782917|NCT01463033|P2|Participant Flow|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
782918|NCT01463033|P1|Participant Flow|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
782919|NCT01463033|O1|Outcome|Participants|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. schedule were monitored for adverse events through the 30 day treatment period.
782920|NCT01463033|O2|Outcome|Observational|60 subjects with acute head injury with a high risk for developing post-traumatic epilepsy enrolled 8-24 hours after injury will not receive levetiracetam. Subjects will receive phenytoin for 1 week following head injury as standard clinical care.
782921|NCT01463033|O1|Outcome|Levetiracetam|66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy will receive levetiracetam 55 mg/kg/day in a b.i.d. schedule. Treatment will commence within 8 hours of the acute head injury and will last for 30 days. In addition, subjects will receive phenytoin for 1 week following head injury as standard clinical care.
782922|NCT01463033|E2|Reported Event|Observational|Adverse events were not monitored for the Observational group
782923|NCT01463033|E1|Reported Event|Levetiracetam|The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
782924|NCT01463007|B1|Baseline|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
782925|NCT01463007|P1|Participant Flow|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
782926|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
782927|NCT01463007|O2|Outcome|Extended to 5 Years of Follow Up-Rhode Island Hospital Only|Follow up has been extended to include follow up visits at 2,6 weeks and at 4,6,12,18,24 months then annually (+/- 6 months) for an additional 3 years for a total of approximately 5 years of follow up.
782928|NCT01463007|O1|Outcome|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
782929|NCT01463007|E1|Reported Event|Radiation|"AccuBoost APBI- 34.0 Gy in 10fx~Accelerated partial breast irradiation: Accuboost APBI 34.0 Gy in 10 fractions"
782930|NCT01462942|B6|Baseline|Total|Total of all reporting groups
782931|NCT01462942|B5|Baseline|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782932|NCT01462942|B4|Baseline|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782933|NCT01462942|B3|Baseline|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782934|NCT01462942|B2|Baseline|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782935|NCT01462942|B1|Baseline|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782936|NCT01462942|P5|Participant Flow|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782937|NCT01462942|P4|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782938|NCT01462942|P3|Participant Flow|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782939|NCT01462942|P2|Participant Flow|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782940|NCT01462942|P1|Participant Flow|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782941|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782942|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
814975|NCT01344447|O2|Outcome|Non-contrast MRA|
782943|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782944|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782945|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782946|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782947|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782948|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782949|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782950|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782951|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782952|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782953|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782954|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782955|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782956|NCT01462942|O5|Outcome|Formoterol 12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782957|NCT01462942|O4|Outcome|Aclidinium 400 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782958|NCT01462942|O3|Outcome|Aclidinium/Formoterol 400/6 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782959|NCT01462942|O2|Outcome|Aclidinium/Formoterol 400/12 μg|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782960|NCT01462942|O1|Outcome|Placebo|Administered BID by inhalation, in the mornings and evenings using a multi-dose dry powder inhaler (Genuair®)
782961|NCT01462942|E5|Reported Event|Formoterol 12 μg|
782962|NCT01462942|E4|Reported Event|Aclidinium 400 μg|
782963|NCT01462942|E3|Reported Event|Aclidinium/Formoterol 400/6 μg|
782964|NCT01462942|E2|Reported Event|Aclidinium/Formoterol 400/12 μg|
782965|NCT01462942|E1|Reported Event|Placebo|
782966|NCT01462929|B4|Baseline|Total|Total of all reporting groups
782967|NCT01462929|B3|Baseline|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
782968|NCT01462929|B2|Baseline|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
782969|NCT01462929|B1|Baseline|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
782970|NCT01462929|P3|Participant Flow|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
782971|NCT01462929|P2|Participant Flow|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
782972|NCT01462929|P1|Participant Flow|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
782973|NCT01462929|O3|Outcome|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
782974|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
782975|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
785722|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
782976|NCT01462929|O3|Outcome|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
783067|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
782977|NCT01462929|O2|Outcome|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
782978|NCT01462929|O1|Outcome|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
782979|NCT01462929|E3|Reported Event|Placebo|"Placebo~Route of administration:~Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 capsule of placebo in the morning (09:00 ± 1h)."
782980|NCT01462929|E2|Reported Event|Tiotropium 18 μg Once-daily|"Tiotropium 18 μg administered once daily~Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler.~Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)~AND~1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) via oral inhalation by Genuair multidose dry powder inhaler."
782981|NCT01462929|E1|Reported Event|Aclidinium Bromide 400 µg BID|"Aclidinium bromide 400 µg administered twice per day~Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler.~Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)~AND~1 capsule of placebo in the morning (09:00 ± 1h) via oral inhalation by HandiHaler single-dose dry powder inhaler."
782982|NCT01462877|B1|Baseline|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782983|NCT01462877|P1|Participant Flow|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782984|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782985|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782986|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782987|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782988|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782989|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782990|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782991|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782992|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782993|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782994|NCT01462877|O1|Outcome|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782995|NCT01462877|E1|Reported Event|Fenofibrate Arm|fenofibrate: Fenofibrate Capsule 200mg qd orally
782996|NCT01462812|B3|Baseline|Total|Total of all reporting groups
782997|NCT01462812|B2|Baseline|Sumatriptan|Sumatriptan : Sumatriptan 20mg
782998|NCT01462812|B1|Baseline|Matching Placebo|Placebo : Matching placebo
782999|NCT01462812|P2|Participant Flow|Sumatriptan|Sumatriptan : Sumatriptan 20mg
783000|NCT01462812|P1|Participant Flow|Matching Placebo|Placebo : Matching placebo
783001|NCT01462812|O2|Outcome|Sumatriptan|Sumatriptan : Sumatriptan 20mg
783002|NCT01462812|O1|Outcome|Matching Placebo|Placebo : Matching placebo
783003|NCT01462812|E2|Reported Event|Sumatriptan|Sumatriptan : Sumatriptan 20mg
783004|NCT01462812|E1|Reported Event|Matching Placebo|Placebo : Matching placebo
783005|NCT01462773|B1|Baseline|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients receive bortezomib IV over 3-5 seconds on days 1, 8, 15, and 22 and recombinant interferon alfa-2b SC on days 1, 3, and 5 (days 1 and 3 only in week 4 course 1) of weeks 1-4. Treatment repeats every 5 weeks for 5 courses in the absence of disease progression or unacceptable toxicity.
783006|NCT01462773|P1|Participant Flow|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
783007|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Bortezomib was administered intravenously weekly along with IFN-a thrice weekly.
783008|NCT01462773|O1|Outcome|Bortezomib & Interferon-a|Patients were treated on a 5-week cycle. Week 1 of cycle 1, patients received 5 million U/m(2) IFN-a subcutaneously thrice weekly. Weeks 2-4 of cycle 1, bortezomib was administered intravenously weely along with IFN-a thrice weekly. A break from treatment during week 5. Folllowing cycle 1, bortezomib was administered in combination iwth IFN-a. Bortezomib was administered in escalating doses to cohorts of 3 patients.
783009|NCT01462773|E1|Reported Event|Treatment (Enzyme Inhibitor, Interferon Therapy)|Patients were treated on a 5-week cycle. In week 1 of cycle 1, patients received 5 million U/m(2) IFN-α subcutaneously thrice weekly. During weeks 2-4 of cycle 1, bortezomib was administered intravenously weekly along with IFN-α thrice weekly. There was a treatment break during week 5. After cycle 1, bortezomib was administered in combination with IFN-α. Bortezomib was administered in escalating doses (1.0, 1.3, or 1.6 mg/m) to cohorts of 3 patients.
783010|NCT01462695|B3|Baseline|Total|Total of all reporting groups
783011|NCT01462695|B2|Baseline|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
783012|NCT01462695|B1|Baseline|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
783068|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783069|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783013|NCT01462695|P2|Participant Flow|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
783014|NCT01462695|P1|Participant Flow|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
783015|NCT01462695|O2|Outcome|Stratum B: Recurrent Ependymoma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
783016|NCT01462695|O1|Outcome|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
783017|NCT01462695|E2|Reported Event|Stratum B: Recurrent Ependymoma|Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.
783018|NCT01462695|E1|Reported Event|Stratum A: Recurrent High Grade Glioma|"Patients receive sunitinib malate orally (PO) once daily (QD) on days 1-28. Treatment repeats every 42 days for up to 18 courses in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~diagnostic laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
783019|NCT01462435|B5|Baseline|Total|Total of all reporting groups
783020|NCT01462435|B4|Baseline|Placebo|Placebo : Capsules
783021|NCT01462435|B3|Baseline|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783022|NCT01462435|B2|Baseline|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783023|NCT01462435|B1|Baseline|Celecoxib|Celecoxib : 200 mg Capsules
783024|NCT01462435|P4|Participant Flow|Placebo|Placebo : Capsules
783025|NCT01462435|P3|Participant Flow|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783026|NCT01462435|P2|Participant Flow|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783027|NCT01462435|P1|Participant Flow|Celecoxib|Celecoxib : 200 mg Capsules
783028|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783029|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783030|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783031|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783032|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783033|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783034|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783035|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783036|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783037|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783038|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783039|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783040|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783041|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783042|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783043|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783044|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783045|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783046|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783047|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783048|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783049|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783050|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783051|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783052|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783053|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783054|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783055|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783056|NCT01462435|O4|Outcome|Placebo|Placebo : Capsules
783057|NCT01462435|O3|Outcome|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783058|NCT01462435|O2|Outcome|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783059|NCT01462435|O1|Outcome|Celecoxib|Celecoxib : 200 mg Capsules
783060|NCT01462435|E4|Reported Event|Placebo|Placebo : Capsules
783061|NCT01462435|E3|Reported Event|Diclofenac Test (Upper Dose)|Diclofenac Test (upper dose) : Capsules
783062|NCT01462435|E2|Reported Event|Diclofenac Test (Lower Dose)|Diclofenac Test (lower dose) : Capsules
783063|NCT01462435|E1|Reported Event|Celecoxib|Celecoxib : 200 mg Capsules
783064|NCT01462370|B1|Baseline|All Randomized Participants|All participants randomized into the study.
783065|NCT01462370|P2|Participant Flow|Ibuprofen Up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to for times a day as needed for a maximum of 2400 mg/day in menstrual cyle 1. In menstrual cycle 2, etoricoxib 120 mg ws given orally for one dose.
783066|NCT01462370|P1|Participant Flow|Etoricoxib 120 mg/ Ibuprofen Up to 2400 mg|Etoricoxib 120 mg tablet given orally or one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
783071|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783072|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783073|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783074|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783075|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783076|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783077|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783078|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783079|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783080|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783081|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783082|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783083|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783084|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783085|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783086|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783087|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783088|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783089|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783090|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783091|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783092|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783093|NCT01462370|O2|Outcome|Ibuprofen up to 2400 mg|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
783094|NCT01462370|O1|Outcome|Etoricoxib 120 mg|Etoricoxib 120 mg tablet given orally for one dose.
783095|NCT01462370|E2|Reported Event|Ibuprofen up to 2400 mg / Etoricoxib 120 mg|Ibuprofen 600 mg given orally up to four times a day as needed, for a maximum of 2400 mg/day in menstrual cycle 1. In menstrual cycle 2, etoricoxib was administered at a dose of 120 mg daily.
783096|NCT01462370|E1|Reported Event|Etoricoxib 120 mg / Ibuprofen up to 2400 mg/Daily|Etoricoxib 120 mg tablet given orally for one dose in menstrual cycle 1. In menstrual cycle 2, ibuprofen was administered at a dose of 600 mg every 4 hours as needed up to 2400 mg/day.
783097|NCT01462357|B4|Baseline|Total|Total of all reporting groups
783098|NCT01462357|B3|Baseline|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783099|NCT01462357|B2|Baseline|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783100|NCT01462357|B1|Baseline|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783101|NCT01462357|P3|Participant Flow|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783102|NCT01462357|P2|Participant Flow|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783103|NCT01462357|P1|Participant Flow|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783104|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783105|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783106|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783336|NCT01461993|E2|Reported Event|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783107|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783108|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
785259|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
783109|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783110|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783111|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783112|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783113|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783114|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783115|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783116|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783117|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783118|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783119|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783120|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783121|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783122|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783123|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783124|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783125|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783126|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783127|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783128|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783129|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783130|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783131|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783132|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783133|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783134|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783243|NCT01462227|P2|Participant Flow|Placebo First/ Naltrexone (Lower Dose) Second|Placebo given given 12 hours prior to visit orally Naltrexone 50 mg (1 tablet) given at time of visit orally
783135|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783244|NCT01462227|P1|Participant Flow|Naltrexone (Lower Dose) First /Placebo Second|Naltrexone 50 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
783136|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783137|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783138|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783139|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783140|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783141|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783142|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783143|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783144|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783145|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783146|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783147|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783148|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783149|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783150|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783151|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783152|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783153|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783154|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783155|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783156|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783157|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783158|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783159|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783160|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783161|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783162|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783329|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783163|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783164|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783165|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783166|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783167|NCT01462357|O3|Outcome|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783168|NCT01462357|O2|Outcome|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783169|NCT01462357|O1|Outcome|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783170|NCT01462357|E3|Reported Event|Gardasil 3 Dose Group|Subjects who received 3 doses of Gardasil® vaccine at Day 0 and at Months 2 and 6. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783171|NCT01462357|E2|Reported Event|Gardasil 2 Dose Group|Subjects who received 2 doses of Gardasil® vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783172|NCT01462357|E1|Reported Event|Cervarix 2 Dose Group|Subjects who received 2 doses of CervarixTM vaccine at Day 0 and Month 6 and 1 dose of placebo at Month 2. The vaccines were administered intramuscularly, in the deltoid muscle of the non-dominant upper arm.
783173|NCT01462344|B3|Baseline|Total|Total of all reporting groups
783174|NCT01462344|B2|Baseline|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783175|NCT01462344|B1|Baseline|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783176|NCT01462344|P2|Participant Flow|Fluticasone Propionate (FP)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783177|NCT01462344|P1|Participant Flow|Fluticasone Propionate/Salmeterol Combination (FSC)|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783178|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783179|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783180|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783208|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783408|NCT01461733|P1|Participant Flow|Amiodarone|standard dose amiodarone
783245|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783181|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783182|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783183|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783184|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783185|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783186|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783187|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783188|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783189|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783190|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783191|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783192|NCT01462344|O2|Outcome|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783242|NCT01462227|P3|Participant Flow|Naltrexone (Higher Dose) First /Placebo Second|Naltrexone 100 mg, 1 tablet given 12 hours prior to visit orally Placebo given at time of visit orally
783409|NCT01461733|O2|Outcome|Placebo|Placebo: placebo delivered blinded
783193|NCT01462344|O1|Outcome|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783194|NCT01462344|E2|Reported Event|FP DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of the following treatments: FP 100 µg or FP 250 µg as one inhalation BID (approximately 12 hours apart) via DPI during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via MDI was permitted during study treatment.
783195|NCT01462344|E1|Reported Event|FSC DPI|Participants were randomized to either FSC or FP, and the treatment dose was based on participants' asthma control status. There was no intent to compare the dosage levels received, therefore participants were combined for comparison regardless of dosage. In this treatment arm, participants received one of following treatments: FSC 100/50 microgram (µg) or FSC 250/50 µg as one inhalation twice daily (BID) (approximately 12 hours apart) via Dry powder inhaler (DPI) during the 6 month treatment period. Rescue medication (albuterol/salbutamol) via metered dose inhaler (MDI) was permitted during study treatment.
783196|NCT01462318|B3|Baseline|Total|Total of all reporting groups
783197|NCT01462318|B2|Baseline|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
783198|NCT01462318|B1|Baseline|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783199|NCT01462318|P3|Participant Flow|Extension Phase|After completion of the washout period from the Main Study or the TP-DI sub-study, eligible participants had the option to resume monthly open-label treatment with DAC HYP 150 mg in the extension phase of the study for up to 3 additional years.
783200|NCT01462318|P2|Participant Flow|Therapeutic Protein-Drug Interaction (TP-DI)Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
783201|NCT01462318|P1|Participant Flow|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783202|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
783203|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
783204|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
783205|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783206|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783207|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
814976|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
783209|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783210|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783211|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783212|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
783213|NCT01462318|O1|Outcome|TP-DI Sub-study|"In Period 1 (Week -1), the probe-drug cocktail (consisting of oral midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg, where the oral vitamin K was used prophylactically to counteract warfarin’s anticoagulant effect) was administered 7 days before the first dose of DAC HYP 150 mg in the 3-year extension phase.~In Period 2, pretreatment with DAC HYP 150 mg was administered at Weeks 0, 4, and 8. The probe-drug cocktail was administered 7 days after the third dose of DAC HYP."
783214|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783215|NCT01462318|O1|Outcome|Main Study|"All participants received DAC HYP 150 mg SC injections every 4 weeks over an initial 24-week treatment period (for a total of 6 injections), followed by a 20-week washout period.~Those participants from the Main Study who enrolled in the Intensive PK sub-study underwent serial DAC HYP PK sampling over the first and the last dosing intervals (on Day 1 [Week 0] and again on Day 141 [Week 20], the last dosing visit)."
783216|NCT01462318|E1|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg by SC injection using the PFS every 4 weeks for24 weeks followed by a 20-week washout period. After completion of the washout period, participants could resume monthly DAC HYP 150 mg using the PFS for up to 3 additional years. Participants in the TP-DI sub-study received s probe-drug cocktail administration at Weeks 43 and 53. The probe-drug cocktail consisted of midazolam 5 mg, caffeine 200 mg, S-warfarin 10 mg, vitamin K 10 mg, omeprazole 40 mg, and dextromethorphan 30 mg. The oral vitamin K was used to counteract warfarin’s anticoagulant effect prophylactically.
783217|NCT01462279|B1|Baseline|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
783218|NCT01462279|P1|Participant Flow|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
783219|NCT01462279|O1|Outcome|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
783220|NCT01462279|E1|Reported Event|Thiamine|"Open label - 200mg IV~Thiamine: 200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once"
783221|NCT01462266|B3|Baseline|Total|Total of all reporting groups
783222|NCT01462266|B2|Baseline|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783223|NCT01462266|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783224|NCT01462266|P2|Participant Flow|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783225|NCT01462266|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783226|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783227|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783228|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783229|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783230|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783231|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783232|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783233|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783234|NCT01462266|O2|Outcome|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783235|NCT01462266|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783236|NCT01462266|E2|Reported Event|Placebo|Placebo to sitagliptin administered orally once daily for 24 weeks.
783237|NCT01462266|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally once daily for 24 weeks.
783238|NCT01462227|B3|Baseline|Total|Total of all reporting groups
783239|NCT01462227|B2|Baseline|Naltrexone (Higher Dose)|Naltrexone: Naltrexone 100mg, 1 tablet given every 12 hours orally
783240|NCT01462227|B1|Baseline|Naltrexone (Lower Dose)|Naltrexone: Naltrexone 50 mg, 1 tablet given every 12 hours orally
783241|NCT01462227|P4|Participant Flow|Placebo First / Naltrexone (Higher Dose) Second|Placebo given 12 hours prior to visit orally Naltrexone 100 mg (1 tablet) given at time of visit orally
783330|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783246|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783247|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783248|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783249|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783250|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783251|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783252|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783253|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783254|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783255|NCT01462227|O2|Outcome|Naltrexone (Higher Dose)|Subjects were randomized to receive either Naltrexone 100 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783256|NCT01462227|O1|Outcome|Naltrexone (Lower Dose)|Subjects were randomized to receive either Naltrexone 50 mg or placebo: 1 tablet given 12 hours prior to visit orally and again at time of visit.
783257|NCT01462227|E4|Reported Event|Placebo (Higher Dose)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
783258|NCT01462227|E3|Reported Event|Naltrexone (100 mg)|Naltrexone 100 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
783259|NCT01462227|E2|Reported Event|Placebo (Lower Dose Group)|Placebo 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
783260|NCT01462227|E1|Reported Event|Naltrexone (50 mg)|Naltrexone 50 mg, 1 tablet given 12 hours and again at 1 hour prior to testing (orally).
783261|NCT01462162|B1|Baseline|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
783262|NCT01462162|P1|Participant Flow|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
783263|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783264|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783265|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783266|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783267|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783268|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783269|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783331|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783332|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783410|NCT01461733|O1|Outcome|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
783270|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783271|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783272|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783273|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783274|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783275|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783276|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783277|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783278|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783279|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783280|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783281|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783282|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783283|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783284|NCT01462162|O1|Outcome|Rheumatoid Arthritis Participants|Participants with moderate to severe rheumatoid arthritis (RA) who had been considered and proposed by rheumatologist to start treatment with tocilizumab (RoActemra) according to the indications of the summary of product characteristics and the standard clinical practice of each participating center were followed-up for 6 months.
783285|NCT01462162|E1|Reported Event|All Participants|Participants with moderate to severe RA who have been considered and proposed by the rheumatologist to start treatment with Tocilizumab (RoActemra) according to the indications of the summary of product characteristics of the product and the standard clinical practice of each participating center were followed-up for 6 months.
783286|NCT01462084|B1|Baseline|Overall Study Population|All study patients included in final analysis.
783287|NCT01462084|P2|Participant Flow|Bi-Level PAP|Bi-level PAP delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so patients in this arm used Bi-Level PAP therapy the first night and then crossed over and used ASV the second night.
783333|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783334|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783335|NCT01461993|E3|Reported Event|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783288|NCT01462084|P1|Participant Flow|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so patients in this arm used ASV therapy the first night and then crossed over and used BiLevel PAP the second night.
783289|NCT01462084|O2|Outcome|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
783290|NCT01462084|O1|Outcome|Adaptive Servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. Both pressures are fixed and do not adjust based on the individuals breathing events.
783291|NCT01462084|O2|Outcome|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
783292|NCT01462084|O1|Outcome|Adaptive Servo-Ventilation (ASV)|All patients received 1 night of therapy using Adaptive servo-ventilation (ASV) and 1 night of therapy using Bi-level PAP. Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
783293|NCT01462084|E2|Reported Event|Bi-Level PAP|Bi-level pressure delivers two pressures, IPAP and EPAP. Both pressures are fixed and do not adjust based on the individuals breathing events. This is a crossover study, so all patients enter both treatment groups.
783294|NCT01462084|E1|Reported Event|Adaptive Servo-Ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual. ASV adjusts to the breathing events the individual is experiencing and provides enough PAP to resolve the breathing event. This is a crossover study, so all patients enter both treatment groups.
783295|NCT01462045|B4|Baseline|Total|Total of all reporting groups
783296|NCT01462045|B3|Baseline|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
783297|NCT01462045|B2|Baseline|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
783298|NCT01462045|B1|Baseline|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
783299|NCT01462045|P3|Participant Flow|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
783300|NCT01462045|P2|Participant Flow|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
783301|NCT01462045|P1|Participant Flow|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
783302|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
783303|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
783304|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
783305|NCT01462045|O3|Outcome|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
783306|NCT01462045|O2|Outcome|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
783307|NCT01462045|O1|Outcome|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
783308|NCT01462045|E3|Reported Event|Base Group|Healthy volunteers who are not screened positive for PTSD and do not participate in the mindfulness-based exercise.
783309|NCT01462045|E2|Reported Event|Control Group|Participants who are screened positive for PTSD but do not participate in the mindfulness-based exercise.
783310|NCT01462045|E1|Reported Event|Exercise Group|Participants who are screened positive for PTSD and participate in the mindfulness-based exercise.
783311|NCT01461993|B4|Baseline|Total|Total of all reporting groups
783312|NCT01461993|B3|Baseline|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783313|NCT01461993|B2|Baseline|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783314|NCT01461993|B1|Baseline|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783315|NCT01461993|P3|Participant Flow|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783316|NCT01461993|P2|Participant Flow|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783317|NCT01461993|P1|Participant Flow|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783318|NCT01461993|O3|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783319|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783320|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783321|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783322|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783323|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783324|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783325|NCT01461993|O2|Outcome|Group 2: rLP2086 + Saline|Randomized to receive on a 0, 2-, 6- month schedule
783326|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783327|NCT01461993|O2|Outcome|Group 3: Saline + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783328|NCT01461993|O1|Outcome|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783337|NCT01461993|E1|Reported Event|Group 1: rLP2086 + Gardasil|Randomized to receive on a 0, 2-, 6- month schedule
783338|NCT01461980|B4|Baseline|Total|Total of all reporting groups
783339|NCT01461980|B3|Baseline|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783340|NCT01461980|B2|Baseline|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783341|NCT01461980|B1|Baseline|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783342|NCT01461980|P3|Participant Flow|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783343|NCT01461980|P2|Participant Flow|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783344|NCT01461980|P1|Participant Flow|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783345|NCT01461980|O3|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783346|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783347|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783348|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783349|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783350|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783351|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783352|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783353|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783354|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783355|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783356|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783357|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783358|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783359|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783360|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783361|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783362|NCT01461980|O2|Outcome|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783363|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783364|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783365|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783366|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783367|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783368|NCT01461980|O2|Outcome|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783414|NCT01461707|B2|Baseline|Activity Monitor Group|Participants in the group will receive an activity monitor
783449|NCT01461551|O2|Outcome|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
783369|NCT01461980|O1|Outcome|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783370|NCT01461980|E3|Reported Event|Saline+Saline+rLP2086|Randomized to receive Saline on 0- month, rLP2086 vaccine on a 0-, 2-, 6- month schedule, MCV4 and Tdap vaccine on 7- month.
783371|NCT01461980|E2|Reported Event|MCV4+Tdap+Saline|Randomized to receive MCV4 and Tdap vaccine on 0- month, Saline on a 0-, 2-, 6- month schedule.
783372|NCT01461980|E1|Reported Event|MCV4+Tdap+rLP2086|Randomized to receive Quadrivalent meningococcal polysaccharide conjugate (MCV4) and Tetanus, diphtheria, and acellular pertussis (Tdap) vaccine on 0- month, Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
783373|NCT01461811|B3|Baseline|Total|Total of all reporting groups
783374|NCT01461811|B2|Baseline|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783375|NCT01461811|B1|Baseline|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783376|NCT01461811|P2|Participant Flow|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783377|NCT01461811|P1|Participant Flow|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783378|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783379|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783380|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783381|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783382|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783383|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783384|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783385|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783386|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783387|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783388|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783389|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783390|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783391|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783392|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783393|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783394|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783395|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783396|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783397|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783398|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783399|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783400|NCT01461811|O2|Outcome|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783401|NCT01461811|O1|Outcome|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783402|NCT01461811|E2|Reported Event|Focus® DAILIES® Toric|Nelfilcon A toric contact lenses worn in both eyes on a daily wear, daily disposable basis for three months
783403|NCT01461811|E1|Reported Event|DAILIES® AquaComfort Plus® Toric|Nelfilcon A toric contact lenses (with comfort additives) worn in both eyes on a daily wear, daily disposable basis for three months
783404|NCT01461733|B3|Baseline|Total|Total of all reporting groups
783405|NCT01461733|B2|Baseline|Placebo|Placebo: placebo delivered blinded
783406|NCT01461733|B1|Baseline|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
783407|NCT01461733|P2|Participant Flow|Placebo|
783412|NCT01461733|E1|Reported Event|Amiodarone|"standard dose amiodarone~amiodarone: standard dose amiodarone"
783413|NCT01461707|B3|Baseline|Total|Total of all reporting groups
783415|NCT01461707|B1|Baseline|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
783416|NCT01461707|P2|Participant Flow|Activity Monitor Group|Participants in the group will receive an activity monitor
783417|NCT01461707|P1|Participant Flow|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
783418|NCT01461707|O2|Outcome|Activity Monitor Group|Participants in the group will receive an activity monitor
783419|NCT01461707|O1|Outcome|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
783420|NCT01461707|O2|Outcome|Activity Monitor Group|Participants in the group will receive an activity monitor
783421|NCT01461707|O1|Outcome|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
783422|NCT01461707|E2|Reported Event|Activity Monitor Group|Participants in the group will receive an activity monitor
783423|NCT01461707|E1|Reported Event|Mobile App Plus Activity Monitor Group|"Participants in the group will receive a study mobile phone application and an activity monitor~Mobile phone-based physical activity program: Participants in the intervention group will receive an activity monitor and the mobile phone based physical activity intervention."
783424|NCT01461655|B1|Baseline|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783425|NCT01461655|P1|Participant Flow|Topical Retinoid - Placebo, Topical Retinoid - NSAID|"Using a left-right split face set up, the study evaluated the effect of sequential application of topical retinoid 0.1% gel and NSAID 5% gel in comparison with the sequential application of topical retinoid 0.1% gel and vehicle gel for the treatment of acne vulgaris.~The randomised subjects received the following products:~NSAID 5% gel , in the morning on the appropriate hemiface.~Topical retinoid 0.1% gel, in the evening on the entire face.~Vehicle gel, in the morning on the appropriate hemiface."
783426|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
783427|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783428|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
783429|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783430|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
783431|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783432|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
783433|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783434|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
783435|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783436|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
783437|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783438|NCT01461655|O2|Outcome|Topical Retinoid-NSAID|"marketed topical NSAID : once daily application, 4 weeks~marketed topical retinoid : once daily application, 4 weeks"
783439|NCT01461655|O1|Outcome|Topical Retinoid - Placebo|"marketed topical retinoid : once daily application, 4 weeks~vehicle gel : once daily application, 4 weeks"
783440|NCT01461655|E1|Reported Event|Topical Retinoid - Placebo, Topical Retinoid - NSAID|
783441|NCT01461551|B4|Baseline|Total|Total of all reporting groups
783442|NCT01461551|B3|Baseline|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
783443|NCT01461551|B2|Baseline|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
783444|NCT01461551|B1|Baseline|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
783445|NCT01461551|P3|Participant Flow|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
783446|NCT01461551|P2|Participant Flow|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
783447|NCT01461551|P1|Participant Flow|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
783488|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
783448|NCT01461551|O3|Outcome|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
785729|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
783450|NCT01461551|O1|Outcome|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
783451|NCT01461551|E3|Reported Event|Combine of Sevoflurane and Propofol|combine of sevoflurane and propofol: anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
783452|NCT01461551|E2|Reported Event|Propofol|Propofol: anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
783453|NCT01461551|E1|Reported Event|Sevoflurane|Sevoflurane: anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
783454|NCT01461538|B4|Baseline|Total|Total of all reporting groups
783455|NCT01461538|B3|Baseline|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783456|NCT01461538|B2|Baseline|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783457|NCT01461538|B1|Baseline|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783458|NCT01461538|P3|Participant Flow|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783459|NCT01461538|P2|Participant Flow|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783460|NCT01461538|P1|Participant Flow|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783461|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783462|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783463|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783464|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783465|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783466|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783467|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783468|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783469|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783470|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783471|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783472|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783473|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783474|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783475|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783476|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783477|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783478|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783479|NCT01461538|O3|Outcome|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783480|NCT01461538|O2|Outcome|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783481|NCT01461538|O1|Outcome|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783482|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
783483|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
783484|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
783485|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
783486|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
783487|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
783490|NCT01461538|O2|Outcome|Leukemia|Participants with acute leukemia or high grade MDS (refractory anemia with excess blasts-2)
783491|NCT01461538|O1|Outcome|Solid Tumors|Participants with solid tumors
784059|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
783492|NCT01461538|E3|Reported Event|BV 1.2 mg/kg Q1Week|Brentuximab vedotin 1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion in patients with acute leukemia or myelodysplastic syndrome (MDS)
783493|NCT01461538|E2|Reported Event|BV 2.4 mg/kg Q3Week|Brentuximab vedotin 2.4 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783494|NCT01461538|E1|Reported Event|BV 1.8 mg/kg Q3Week|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive solid tumors or leukemia
783495|NCT01461473|B3|Baseline|Total|Total of all reporting groups
783496|NCT01461473|B2|Baseline|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783497|NCT01461473|B1|Baseline|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783498|NCT01461473|P2|Participant Flow|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783499|NCT01461473|P1|Participant Flow|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783500|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783501|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783502|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783503|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783504|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783505|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783506|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783507|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783508|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783509|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783510|NCT01461473|O2|Outcome|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783511|NCT01461473|O1|Outcome|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783512|NCT01461473|E2|Reported Event|Oral Appliance|"Subjects randomized to standard Oral Appliance (OA) treatment for Obstructive Sleep Apnea (OSA).~Oral Appliance: Participants who are randomized to the Oral Appliance Treatment Group will receive a dental evaluation to determine the optimal setting for the Oral Appliance (OA) device."
783696|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783729|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783513|NCT01461473|E1|Reported Event|Positive Airway Pressure|"Participants randomized to standard clinical Positive Airway Pressure (PAP) treatment for Obstructive Sleep Apnea (OSA).~Positive Airway Pressure: Participants who are randomized to the Positive Airway Pressure treatment group will receive adequate Positive Airway Pressure (PAP) pressure setting through standard clinical polysomnography (PSG) study."
783514|NCT01461369|B4|Baseline|Total|Total of all reporting groups
783515|NCT01461369|B3|Baseline|Placebo|Placebo: Capsule
783516|NCT01461369|B2|Baseline|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783517|NCT01461369|B1|Baseline|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783518|NCT01461369|P3|Participant Flow|Placebo|Placebo: Capsule
783519|NCT01461369|P2|Participant Flow|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783520|NCT01461369|P1|Participant Flow|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783521|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
783522|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783523|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783524|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
783525|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783526|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783527|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
783528|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783529|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783530|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
783531|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783532|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783533|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
783534|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783535|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783536|NCT01461369|O3|Outcome|Placebo|Placebo: Capsule
783537|NCT01461369|O2|Outcome|Diclofenac 35 mg Three Times Daily|Diclofenac (three times daily): Capsules
783538|NCT01461369|O1|Outcome|Diclofenac 35 mg Two Times Daily|Diclofenac (two times daily): Capsules
783539|NCT01461369|E3|Reported Event|Placebo|Placebo: Capsule
783540|NCT01461369|E2|Reported Event|Diclofenac 35 mg Three Times Daily|Diclofenac Test (three times daily): Capsules
783541|NCT01461369|E1|Reported Event|Diclofenac 35 mg Two Times Daily|Diclofenac Test (two times daily): Capsules
783542|NCT01461096|B3|Baseline|Total|Total of all reporting groups
783543|NCT01461096|B2|Baseline|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783544|NCT01461096|B1|Baseline|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783545|NCT01461096|P2|Participant Flow|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783546|NCT01461096|P1|Participant Flow|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783547|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783548|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783549|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783550|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783551|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783552|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783553|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783554|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783555|NCT01461096|O2|Outcome|Placebo Vaccine|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783556|NCT01461096|O1|Outcome|Quadrivalent HPV Vaccine|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783557|NCT01461096|E2|Reported Event|Placebo|"Participants were prescribed the placebo vaccine at baseline and Weeks 8 and 24.~Placebo Vaccine for Male Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.~Placebo Vaccine for Female Participants Only: Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783558|NCT01461096|E1|Reported Event|qHPV|"Participants were prescribed the quadrivalent HPV vaccine at baseline and Weeks 8 and 24.~Quadrivalent HPV Vaccine: Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24."
783559|NCT01461057|B3|Baseline|Total|Total of all reporting groups
783560|NCT01461057|B2|Baseline|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
783561|NCT01461057|B1|Baseline|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
783562|NCT01461057|P2|Participant Flow|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
783563|NCT01461057|P1|Participant Flow|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
783564|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
783565|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
783566|NCT01461057|O2|Outcome|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
783567|NCT01461057|O1|Outcome|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
783832|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
783568|NCT01461057|E2|Reported Event|Pertuzumab 840/840 mg|Participants received 840 mg as an IV infusion Q3W for cycles 1-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 mg/m^2 was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg q3w for subsequent cycles.
783569|NCT01461057|E1|Reported Event|Pertuzumab 840/420 mg|Participants received pertuzumab as an intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for cycle 1 and a dose of 420 mg every three weeks (Q3W) for cycles 2-6. Participants in both arms received trastuzumab, cisplatin, and capecitabine. Capecitabine 1000 milligram per meter squared (mg/m^2) was administered orally twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle. Cisplatin 80 mg/m^2 was administered as an IV infusion on Day 1 of each cycle. Trastuzumab was administered as an IV infusion at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 milligram per kilogram (mg/kg) q3w for subsequent cycles.
783570|NCT01461044|B3|Baseline|Total|Total of all reporting groups
783571|NCT01461044|B2|Baseline|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783572|NCT01461044|B1|Baseline|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783573|NCT01461044|P2|Participant Flow|Bevacizumab: Triple Negative (TN) Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783574|NCT01461044|P1|Participant Flow|Bevacizumab: Hormone Receptor-Positive (HR+) Breast Cancer|Participants with human epidermal growth factor receptor 2 negative (HER2-) metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for greater than or equal to (>=) 12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783575|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783576|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783577|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783578|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783579|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783580|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783697|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783581|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783582|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783583|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783584|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783585|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783586|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783587|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783588|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783589|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783590|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783591|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783592|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783698|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783593|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783594|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783595|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783596|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783597|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783598|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783599|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783600|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783601|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HR+ cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months.
783602|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783603|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783604|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783699|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
784091|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
783605|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783606|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783607|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783608|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783609|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783610|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783611|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783612|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783613|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783614|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783615|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783616|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783700|NCT01460446|O1|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783617|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783618|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783619|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783620|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783621|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783622|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783623|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data of participants with HR+ cancer, receiving first-line bevacizumab in combination with chemotherapy for at least 12 months, were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783624|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783625|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783626|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783627|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783628|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783673|NCT01460628|B1|Baseline|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783629|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783630|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783631|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783632|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783633|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783634|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783635|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783636|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783637|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783638|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783639|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783640|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783641|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783695|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
784092|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
783642|NCT01461044|O2|Outcome|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783643|NCT01461044|O1|Outcome|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Retrospective data were collected till inclusion in the study. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783644|NCT01461044|E2|Reported Event|Bevacizumab: TN Breast Cancer|Participants with HER2- metastatic or locally advanced TN breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783645|NCT01461044|E1|Reported Event|Bevacizumab: HR+ Breast Cancer|Participants with HER2- metastatic or locally advanced HR+ breast cancer, who received first-line bevacizumab in combination with chemotherapy for >=12 months and without disease progression for at least 12 months were included. Participants who were alive at inclusion in the study, were prospectively followed for maximum of 18 months. Bevacizumab treatment considering retrospectively and prospectively was approximately 61 months.
783646|NCT01460940|B1|Baseline|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
783647|NCT01460940|P1|Participant Flow|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
783648|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
783649|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
783650|NCT01460940|O1|Outcome|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
783651|NCT01460940|E1|Reported Event|Lenalidomide and Panobinostat|"In the phase I trial, three patients will be enrolled at each dose level, starting at dose level 1 using a standard 3 + 3 dose escalation phase I design.~panobinostat: Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.~lenalidomide: Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days."
783652|NCT01460927|B1|Baseline|TriActive+ RF|Healthy male or female subjects 30-60 years of age, having at least two facial sub-areas (left peri-orbital, right peri-orbital or peri-oral) with visible lines/wrinkles and elastosis, which correlate to a score of 2-6 on the Fitzpatrick Classification of Wrinkling and Degree of Elastosis.
783653|NCT01460927|P1|Participant Flow|TriActive+RF|"Subjects will receive up to 8 treatments on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2days) with evaluation follow-up visits at one (1) week (±2days), one (1) month (±4days), and three (3) months (±4days) following the final treatment. The treatments start at a low power (3W for the small tip, 10W for the medium and large tips) and then gradually increase the setting up to the highest powers available within the tips, checking the subject’s tolerability and reaction of the tissue.~The power is adjusted to suit the subject’s sensitivity and the “depth” of tissue to be treated (deeper tissue requires the larger tip). The goal is to progressively and smoothly reach an epidermal temperature end-point of 43°C. The treatment end-point correlates directly with the measurement of the skin temperature.~The temperature of 43°C should be maintained at the end point for several minutes (3-5min)."
783654|NCT01460927|O5|Outcome|3 Month FU|3 Months after the 8th treatment
783655|NCT01460927|O4|Outcome|1 Month FU|1 Month after the 8th treatment
783656|NCT01460927|O3|Outcome|Pre Treatment 8|After 7 treatments
783657|NCT01460927|O2|Outcome|Pre Treatment 4|After 3 treatments
783658|NCT01460927|O1|Outcome|Baseline|Baseline (before Treatments)
783659|NCT01460927|E1|Reported Event|TriActive+RF|Subjects will receive up to 8 treatments with the TriActive+ RF on at least two facial sub areas (e.g., left peri-orbital, right peri-orbital and/or peri-oral). Treatments will be administered once a week (±2 days).
783660|NCT01460732|B1|Baseline|All Patients|All patients analyzed
783661|NCT01460732|P1|Participant Flow|All Patients|All patients analyzed
783662|NCT01460732|O2|Outcome|HBPM-Nocturnal|Dippers defined by HBPM-Nocturnal.
783663|NCT01460732|O1|Outcome|ABPM|Dippers defined by ABPM.
783664|NCT01460732|O1|Outcome|All Patients|All patients analyzed
783674|NCT01460628|P1|Participant Flow|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783675|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783676|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783677|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783678|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783679|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783680|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783681|NCT01460628|O1|Outcome|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783682|NCT01460628|E1|Reported Event|Armodafinil|Armodafinil is the drug being tested. Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio.
783683|NCT01460446|B3|Baseline|Total|Total of all reporting groups
783684|NCT01460446|B2|Baseline|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783685|NCT01460446|B1|Baseline|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783686|NCT01460446|P2|Participant Flow|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783687|NCT01460446|P1|Participant Flow|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783688|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783689|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783690|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783691|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783692|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783693|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783694|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
784056|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
783701|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783702|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783703|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783704|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783705|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783706|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783707|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783708|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783709|NCT01460446|O2|Outcome|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783710|NCT01460446|O1|Outcome|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783711|NCT01460446|E2|Reported Event|Aviva Nano Blood Glucose Meter|Participants used the Accu-Chek® Aviva Nano blood glucose meter and manual bolus calculation to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783712|NCT01460446|E1|Reported Event|Aviva Expert Blood Glucose Meter|Participants used the Accu-Chek® Aviva Expert blood glucose meter with an integrated bolus advisor to determine the dose of insulin for each injection in their 24 week multiple daily injection therapy.
783713|NCT01460342|B3|Baseline|Total|Total of all reporting groups
783714|NCT01460342|B2|Baseline|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783715|NCT01460342|B1|Baseline|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783716|NCT01460342|P2|Participant Flow|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783717|NCT01460342|P1|Participant Flow|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783718|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783719|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783720|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783721|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783722|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783723|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783724|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783725|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783726|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783727|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783728|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783730|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783731|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783732|NCT01460342|O2|Outcome|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783733|NCT01460342|O1|Outcome|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783734|NCT01460342|E2|Reported Event|Tadalafil|Tadalafil: 5 mg (two 2.5-mg tablets), given orally once daily for 12 weeks, during the double-blind treatment period. This followed a 4-week placebo lead-in period [2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily].
783735|NCT01460342|E1|Reported Event|Placebo|Placebo: 2 tablets [identical to 2.5-milligram (mg) tadalafil tablets] given orally once daily for 4 weeks, during the placebo lead-in period and for 12 weeks, during the double-blind treatment period.
783736|NCT01460290|B1|Baseline|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg/day and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study."
783737|NCT01460290|P1|Participant Flow|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
783738|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783739|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783740|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783741|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783742|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783743|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783744|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783745|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783746|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783747|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783748|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783834|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
825274|NCT01309802|O1|Outcome|Placebo|no intervention
783749|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783750|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783751|NCT01460290|O1|Outcome|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783752|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
783753|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
783754|NCT01460290|O1|Outcome|Asenapine|12-weeks of open-label asenapine treatment. Asenapine was administered open-label in pill form. Asenapine was initiated at 5 mg and increased as tolerated to a maximum of 20 mg/day. A control group was not used for this study.
783755|NCT01460290|E1|Reported Event|Asenapine|"12-weeks of open-label asenapine treatment~Asenapine: Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist."
783756|NCT01459913|B5|Baseline|Total|Total of all reporting groups
783757|NCT01459913|B4|Baseline|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
783758|NCT01459913|B3|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
783759|NCT01459913|B2|Baseline|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783760|NCT01459913|B1|Baseline|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783761|NCT01459913|P4|Participant Flow|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
783762|NCT01459913|P3|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
783763|NCT01459913|P2|Participant Flow|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783764|NCT01459913|P1|Participant Flow|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 milligram (mg) tablet twice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met rapid viral response (RVR, undetectable Hepatitis C Virus [HCV] Ribonucleic Acid [RNA] at Week 4) criteria, were randomized in this group, as planned, and did not receive any further treatment.
785723|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
783765|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
783766|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
783767|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783768|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783769|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783770|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783771|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783772|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783773|NCT01459913|O5|Outcome|Telaprevir+Peg-IFN-alfa-2a, RBV (Total)|All subjects who received telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, up to 48 weeks.
783774|NCT01459913|O4|Outcome|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
783775|NCT01459913|O3|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
783776|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783777|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783778|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783833|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783779|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783780|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783781|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783782|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783783|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783784|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783785|NCT01459913|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783786|NCT01459913|O2|Outcome|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783787|NCT01459913|O1|Outcome|Telaprevir 12 Week (Wk)+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783788|NCT01459913|E4|Reported Event|Telaprevir 12 Wk +Peg-IFN-alfa-2a,RBV 48 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks. Only subjects with no RVR or no RVR assessment, and subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, who did not have eRVR or eRVR assessment, were included in this group, as planned.
783789|NCT01459913|E3|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Non Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects with RVR who permanently discontinued telaprevir, Peg-IFN-alfa-2a, or RBV treatment before Week 12, and had extended rapid viral response (eRVR, undetectable HCV RNA at Weeks 4 and 12), were included in this group, as planned.
783790|NCT01459913|E2|Reported Event|Telaprevir 12 Wk+Peg-IFN-alfa-2a,RBV 24 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned.
783791|NCT01459913|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Wk (Randomized)|Telaprevir 1125 mg tablet twice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks. Only subjects who completed initial 12 week of telaprevir and Peg-IFN/RBV and met RVR criteria, were randomized in this group, as planned, and did not receive any further treatment.
783792|NCT01459783|B3|Baseline|Total|Total of all reporting groups
783812|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783793|NCT01459783|B2|Baseline|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
783794|NCT01459783|B1|Baseline|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
783795|NCT01459783|P2|Participant Flow|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
783796|NCT01459783|P1|Participant Flow|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
783797|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
783798|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
783799|NCT01459783|O2|Outcome|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
783829|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783830|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
814977|NCT01344447|O2|Outcome|Unenhanced MRA|
783800|NCT01459783|O1|Outcome|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
783801|NCT01459783|E2|Reported Event|Dementia Care Management Telephone Only|"The dementia care management protocol will be delivered via telephonic meetings only. Assessment, education, counseling, and social support procedures as well as referral and follow-ups will follow the same procedural content as stipulated for the face-to-face intervention, however, contact will not be planned in person.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals and proactive follow-up."
783802|NCT01459783|E1|Reported Event|Dementia Care Management in Person|"The dementia care management protocol will be delivered via face-to-face interactions in participants' homes or in mutually convenient locations between a trained care manager and the care recipient/informal family caregiver dyad, supplemented by telephone.~Dementia care management: Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems."
783803|NCT01459705|B4|Baseline|Total|Total of all reporting groups
783804|NCT01459705|B3|Baseline|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
783805|NCT01459705|B2|Baseline|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783806|NCT01459705|B1|Baseline|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783807|NCT01459705|P3|Participant Flow|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
783808|NCT01459705|P2|Participant Flow|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783809|NCT01459705|P1|Participant Flow|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783810|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783811|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783831|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
814978|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
783813|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783814|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
783815|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783816|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783817|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
783818|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783819|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783820|NCT01459705|O3|Outcome|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
783821|NCT01459705|O2|Outcome|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783822|NCT01459705|O1|Outcome|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783823|NCT01459705|E3|Reported Event|Waitlist|"The waitlist (WL) participants will be asked to refrain from psychotherapy during the 5 weeks of study participation.~Waitlist: This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation"
783824|NCT01459705|E2|Reported Event|Virtual Reality Exposure Therapy (VRET)|"The VRET protocol follows the same procedures as the PE protocol with the primary exception being that all instances of imaginal exposure will be augmented by immersion into Virtual Iraq environments, thus creating a situation known as immersive exposure.~Virtual Reality Exposure Therapy (VRET): Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments."
783825|NCT01459705|E1|Reported Event|Prolonged Exposure Therapy (PE)|"The PE protocol is based on manualized procedures, which are derived from the theory that effective treatment for PTSD requires that the underlying pathological fear structure be activated and paired with new information that is incompatible with the fear structure. PE involves imaginal exposure and in vivo exposure as the two primary strategies to elicit repeated confrontation of feared but objectively safe thoughts, feelings, situations and events.~Prolonged Exposure Therapy (PE): Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments."
783826|NCT01459653|B1|Baseline|EP2006, Evaluable Sample|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Only patients who had no major protocol violations and have a minimum of enrollment cycle and either one follow-up cycle or study end data with valid outcome data (i.e., ANC or completed CIN/FN data) belong to the evaluable sample and are analyzed.
783827|NCT01459653|P1|Participant Flow|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783828|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN
818124|NCT01333397|O2|Outcome|Dysport NG 20 U|
783835|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783836|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783837|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783838|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783839|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783840|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783841|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783842|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783843|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783844|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783845|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783846|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783847|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783848|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783849|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783850|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783851|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783852|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783853|NCT01459653|O3|Outcome|EP2006: Over Treated|Over treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783854|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Correctly treated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783855|NCT01459653|O1|Outcome|EP2006: Undertreated|Undertreated cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783856|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
783857|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
783858|NCT01459653|O2|Outcome|EP2006: No CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had no CIN/FN-related chemotherapy disturbance
783859|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN who had any CIN/FN-related chemotherapy disturbance
783860|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with no grade 4 CIN/FN
783861|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with any grade 4 CIN/FN
783862|NCT01459653|O2|Outcome|EP2006: no CIN/FN-related Chemotherapy Disturbance|Cancer patients having no CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783863|NCT01459653|O1|Outcome|EP2006: Any CIN/FN-related Chemotherapy Disturbance|Cancer patients having any CIN/FN-related chemotherapy disturbance treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783864|NCT01459653|O2|Outcome|EP2006: No Grade 4 CIN/FN|Cancer patients with no grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783865|NCT01459653|O1|Outcome|EP2006: Any Grade 4 CIN/FN|Cancer patients with any grade 4 CIN/FIN treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
784093|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
783866|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783867|NCT01459653|O3|Outcome|EP2006: >=6 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with >=6 days of study drug duration.
783868|NCT01459653|O2|Outcome|EP2006: 4-5 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 4-5 days of study drug duration.
783869|NCT01459653|O1|Outcome|EP2006: 1-3 Days Duration|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with 1-3 days of study drug duration.
783870|NCT01459653|O3|Outcome|EP2006: Day 4 or Later|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 4 or later
783871|NCT01459653|O2|Outcome|EP2006: Days 1-3 (Per Guidelines)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on days 1-3 (per guidelines)
783872|NCT01459653|O1|Outcome|EP2006: Day 0 (During Chemotherapy)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN that initiated study drug on day 0 (during chemotherapy)
783873|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783874|NCT01459653|O3|Outcome|EP2006: Mean GIS 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 1
783875|NCT01459653|O2|Outcome|EP2006: Mean GIS 0.51-0.99|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0.51-0.99
783876|NCT01459653|O1|Outcome|EP2006: Mean GIS 0-0.5|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN with mean GIS 0-0.5
783877|NCT01459653|O2|Outcome|EP2006: 48MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 48MIU/day
783878|NCT01459653|O1|Outcome|EP2006: 30MIU/Day|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, treated with 30MIU/day
783879|NCT01459653|O3|Outcome|EP2006: Overtreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, overtreated relative to guidelines.
783880|NCT01459653|O2|Outcome|EP2006: Correctly Treated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, correctly treated relative to guidelines
783881|NCT01459653|O1|Outcome|EP2006: Undertreated|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN, undertreated relative to guidelines
783882|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN
783883|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN
783884|NCT01459653|O3|Outcome|EP2006: High (>20%) Risk|Cancer patients treated with chemotherapy with high risk(>20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783885|NCT01459653|O2|Outcome|EP2006: Medium (10-20%) Risk|Cancer patients treated with chemotherapy with medium risk(10-20%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783886|NCT01459653|O1|Outcome|EP2006: Low (<10%) Risk|Cancer patients treated with chemotherapy with low risk(<10%) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783887|NCT01459653|O1|Outcome|EP2006 Cycle Level|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783888|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783889|NCT01459653|O1|Outcome|EP2006 Cycles|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783890|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783891|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783892|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783893|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783894|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783895|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783896|NCT01459653|O3|Outcome|EP2006: EP2006 Initiation Later (Day 4 or More)^|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation later (day 4 or more).
818125|NCT01333397|O1|Outcome|Placebo|
783962|NCT01459653|O2|Outcome|EP2006: >=65 Years|Cancer patients >=65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783897|NCT01459653|O2|Outcome|EP2006: EP 2006 Initiation Per Guidelines (Days 1-3)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP 2006 initiation per guidelines (days 1-3).
783898|NCT01459653|O1|Outcome|EP2006: EP2006 Initiation During Chemotherapy (Day 0)|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (EP2006 initiation during chemotherapy, day 0).
783899|NCT01459653|O3|Outcome|EP2006: Hematological Tumor|Cancer patients (Hematological tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783900|NCT01459653|O2|Outcome|EP2006: Solid Tumor|Cancer patients (Solid tumor) treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783901|NCT01459653|O1|Outcome|EP2006: All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783902|NCT01459653|O3|Outcome|EP2006, <10% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (<10% chemo-associated FN risk).
783903|NCT01459653|O2|Outcome|EP2006, 10-20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (10-20% chemo-associated FN risk).
783904|NCT01459653|O1|Outcome|EP2006, >20% Chemo-associated FN Risk|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (>20% chemo-associated FN risk)
783905|NCT01459653|O3|Outcome|EP2006 - Hematological Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Hematological tumor).
783906|NCT01459653|O2|Outcome|EP2006 - Solid Tumor|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (Solid tumor).
783907|NCT01459653|O1|Outcome|EP2006 - All Patients|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN (all patients).
783908|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783909|NCT01459653|O2|Outcome|EP2006 - Group 2|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783910|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783911|NCT01459653|O1|Outcome|EP2006 - Group 1|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783912|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783913|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783914|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783915|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783916|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783917|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
783918|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
783919|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783920|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783921|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783922|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783923|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783924|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783925|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783926|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783927|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783928|NCT01459653|O3|Outcome|EP2006: >20% Risk|Cancer patients treated with chemotherapy with high toxicity (>20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783929|NCT01459653|O2|Outcome|EP2006: 10-20% Risk|Cancer patients treated with chemotherapy with medium toxicity (10-20% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783930|NCT01459653|O1|Outcome|EP2006: <10% Risk|Cancer patients treated with chemotherapy with low toxicity (<10% risk) and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783931|NCT01459653|O2|Outcome|EP2006: Secondary Prophylaxis|Cancer patients treated with chemotherapy as and who are prescribed commercially available filgrastim biosimilar for secondary prophylaxis for FN.
783932|NCT01459653|O1|Outcome|EP2006: Primary Prophylaxis|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary prophylaxis for FN.
783933|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783934|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783935|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783936|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783937|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783938|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783939|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783940|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783941|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783942|NCT01459653|O3|Outcome|EP2006: Risk >20%|Cancer patients with chemotherapy toxicity >20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783943|NCT01459653|O2|Outcome|EP2006: Risk 10-20%|Cancer patients with chemotherapy toxicity 10-20% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783944|NCT01459653|O1|Outcome|EP2006: Risk <10%|Cancer patients with chemotherapy toxicity <10% treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783945|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783946|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783947|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783948|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783949|NCT01459653|O2|Outcome|EP2006: >65kg|Cancer patients weighing >65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783950|NCT01459653|O1|Outcome|EP2006: <=65kg|Cancer patients weighing <=65kg treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783951|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783952|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783953|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783954|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783955|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783956|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783957|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783958|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783959|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783960|NCT01459653|O2|Outcome|EP2006: Hematological Tumor|Cancer patients with hematological tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783961|NCT01459653|O1|Outcome|EP2006: Solid Tumor|Cancer patients with solid tumor treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
818126|NCT01333397|O5|Outcome|Dysport 50 U|
783963|NCT01459653|O1|Outcome|EP2006: <65 Years|Cancer patients <65 years treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783964|NCT01459653|O2|Outcome|EP2006: Female|Female cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783965|NCT01459653|O1|Outcome|EP2006: Male|Male cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783966|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783967|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783968|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783969|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783970|NCT01459653|O1|Outcome|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN.
783971|NCT01459653|E1|Reported Event|EP2006|Cancer patients treated with chemotherapy and who are prescribed commercially available filgrastim biosimilar for primary or secondary prophylaxis for FN. Number 1496 refers to the total number of patients who received at least one dose of study medication EP2006.
783972|NCT01459588|B5|Baseline|Total|Total of all reporting groups
783973|NCT01459588|B4|Baseline|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783974|NCT01459588|B3|Baseline|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783975|NCT01459588|B2|Baseline|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783976|NCT01459588|B1|Baseline|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783977|NCT01459588|P4|Participant Flow|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783978|NCT01459588|P3|Participant Flow|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783979|NCT01459588|P2|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783980|NCT01459588|P1|Participant Flow|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783981|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783982|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783983|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783984|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783985|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783986|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783987|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783988|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783989|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783990|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783991|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
784094|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784058|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
783992|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783993|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783994|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783995|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783996|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783997|NCT01459588|O4|Outcome|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
783998|NCT01459588|O3|Outcome|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
783999|NCT01459588|O2|Outcome|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
784000|NCT01459588|O1|Outcome|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
784001|NCT01459588|E4|Reported Event|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
784002|NCT01459588|E3|Reported Event|Carboxymethylcellulose Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
784003|NCT01459588|E2|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
784004|NCT01459588|E1|Reported Event|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
784005|NCT01459068|B3|Baseline|Total|Total of all reporting groups
784006|NCT01459068|B2|Baseline|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784007|NCT01459068|B1|Baseline|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784008|NCT01459068|P2|Participant Flow|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784009|NCT01459068|P1|Participant Flow|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784010|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784011|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784026|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784057|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
818127|NCT01333397|O4|Outcome|Dysport NG 75 U|
784012|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784013|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784014|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784015|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784016|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784017|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784018|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784019|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784020|NCT01459068|O2|Outcome|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784021|NCT01459068|O1|Outcome|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784022|NCT01459068|E2|Reported Event|Common Elements Treatment Approach|"Eligible study subjects randomized into the CETA intervention were offered ten weeks of counseling sessions, consisting of nine elements designed to treat symptoms of common mental health disorders including depression, PTS, and anxiety and to provide skills to deal with life stressors.~Common Elements Treatment Approach: CETA components include:~Engagement (encouraging participation)~Psychoeducation (introduction)~Anxiety Management Strategies (relaxation)~Behavioral Activation (getting active)~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)~Imaginal Gradual Exposure (talking about difficult memories)~In Vivo Exposure (Live exposure)~Suicide/Homicide/Danger Assessment and Planning (safety)~Screening and Brief Intervention for Alcohol (alcohol intervention)"
784023|NCT01459068|E1|Reported Event|Waitlist-Control|Eligible study subjects were assigned to the waitlist-control arm on a rolling admissions basis. The waitlist-controls waited for a period equivalent to the duration of the intervention and then were re-interviewed.
784024|NCT01459016|B1|Baseline|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784025|NCT01459016|P1|Participant Flow|Standard of Care|Participants with prodromal to mild Alzheimer’s Disease (AD) underwent a florbetapir F 18 positron emission tomography (PET) scan. (Single intravenous microdose of 260 to 370 megabecquerels (MBq) [7 to 10 millicuries (mCi)] of florbetapir.) Those who tested amyloid positive and met other entry criteria received standard of care for up to 12 months (mos). No therapeutic investigational drug intended to treat AD was administered.
784027|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784028|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784029|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784030|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784031|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784032|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784033|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784034|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784035|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784036|NCT01459016|O1|Outcome|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784037|NCT01459016|E1|Reported Event|Standard of Care|Participants with prodromal to mild AD underwent a florbetapir F 18 PET scan. (Single intravenous microdose of 260 to 370 MBq [7 to 10 mCi] of florbetapir.) Those who tested amyloid positive and met other disease diagnostic criteria received standard of care for up to 12 mos. No therapeutic investigational drug intended to treat AD was administered.
784038|NCT01458951|B4|Baseline|Total|Total of all reporting groups
784039|NCT01458951|B3|Baseline|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784040|NCT01458951|B2|Baseline|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784041|NCT01458951|B1|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784042|NCT01458951|P3|Participant Flow|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784043|NCT01458951|P2|Participant Flow|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784044|NCT01458951|P1|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784045|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784046|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784047|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784048|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784049|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784050|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784051|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784052|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784053|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784054|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784055|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
785724|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
784060|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784061|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784062|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784063|NCT01458951|O2|Outcome|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784064|NCT01458951|O1|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784065|NCT01458951|E3|Reported Event|Placebo BID|Participants received tofacitinib-matched placebo tablets, orally, BID for 9 weeks of double blind treatment period.
784066|NCT01458951|E2|Reported Event|Tofacitinib 15 mg BID|Participants received tofacitinib 15 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784067|NCT01458951|E1|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 9 weeks of double blind treatment period.
784068|NCT01458639|B1|Baseline|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784069|NCT01458639|P1|Participant Flow|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784070|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784071|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784072|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784073|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784074|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784075|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784076|NCT01458639|O1|Outcome|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784077|NCT01458639|E1|Reported Event|Overall Study|Xenon-133 Ventilation Planar imaging, followed by Technegas Ventilation SPECT imaging with Technetium-99m (Tc-99m) labeled carbon particles, followed by Technetium 99m (Tc-99m) MAA Perfusion imaging for the diagnosis of pulmonary embolism. Xe-133 V / Tc-99m MAA Q results compared to Technegas V / Tc-99m MAA Q results.
784078|NCT01458587|B3|Baseline|Total|Total of all reporting groups
784079|NCT01458587|B2|Baseline|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
784080|NCT01458587|B1|Baseline|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
784081|NCT01458587|P2|Participant Flow|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
784082|NCT01458587|P1|Participant Flow|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
784083|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784084|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784085|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784086|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784087|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784088|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784089|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784090|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
818128|NCT01333397|O3|Outcome|Dysport NG 50 U|
784095|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784096|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784097|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784098|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784099|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784100|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784101|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784102|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784103|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784104|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784105|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784106|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784107|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784108|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784109|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784110|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784111|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784112|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784113|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784114|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784115|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784116|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784117|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784118|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784119|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784120|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784121|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784122|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784123|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784124|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784125|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784126|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784127|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784128|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784129|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784130|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784131|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784132|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784133|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784134|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784135|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784136|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784137|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784138|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784139|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784140|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784141|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784142|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784143|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784144|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784145|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784146|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784147|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
818129|NCT01333397|O2|Outcome|Dysport NG 20 U|
784148|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784149|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784150|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784151|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784152|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784153|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784154|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784155|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784156|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784157|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784158|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784159|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784160|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784161|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784162|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784163|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784164|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784165|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784166|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784167|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784168|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784169|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784170|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784171|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784172|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784173|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784174|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784175|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784176|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784177|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784178|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784179|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784180|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784181|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784182|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784183|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784184|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784185|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784186|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784187|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784188|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784189|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784190|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784191|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784192|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784193|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784194|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784195|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784196|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784197|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784198|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784199|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784200|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
818130|NCT01333397|O1|Outcome|Placebo|
784201|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784202|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784203|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784204|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784205|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784206|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784207|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784208|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784209|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784210|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784211|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784212|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784213|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784214|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784215|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784216|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784217|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784218|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784219|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784220|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784221|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784222|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784223|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784224|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784225|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784226|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784227|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784228|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784229|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784230|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784231|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784232|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784233|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784234|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784235|NCT01458587|O4|Outcome|VEH-OCC|Vehicle application on one extremity unoccluded during the incubation period.
784236|NCT01458587|O3|Outcome|VEH+OCC|Vehicle application on one extremity occluded with plastic wrap during the incubation period.
784237|NCT01458587|O2|Outcome|ALA-OCC|ALA application on one extremity unoccluded during the incubation period.
784238|NCT01458587|O1|Outcome|ALA+OCC|ALA application on one extremity occluded with plastic wrap during the incubation period.
784239|NCT01458587|E2|Reported Event|Vehicle|Vehicle applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
784240|NCT01458587|E1|Reported Event|Aminolevulinic Acid|ALA applied to both extremities; one extremity on each subject randomized to occlusion with plastic wrap during the incubation period.
784241|NCT01458574|B4|Baseline|Total|Total of all reporting groups
784242|NCT01458574|B3|Baseline|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784243|NCT01458574|B2|Baseline|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784244|NCT01458574|B1|Baseline|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784245|NCT01458574|P3|Participant Flow|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784246|NCT01458574|P2|Participant Flow|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784247|NCT01458574|P1|Participant Flow|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784841|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784248|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784249|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784250|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784251|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784252|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784253|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784254|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784255|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784256|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784257|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784258|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784259|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784260|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784261|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784262|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784263|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784264|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784265|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784266|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784267|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784268|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784269|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784270|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784271|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784272|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784273|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784274|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784275|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784276|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784842|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784277|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784278|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784279|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784280|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784281|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784282|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784283|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784284|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784285|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784286|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784287|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784288|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784289|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784290|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784291|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784292|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784293|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784294|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784295|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784296|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784297|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784298|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784299|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784300|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784301|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784302|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784303|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784304|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784305|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784843|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784306|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784307|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784308|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784309|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784310|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784311|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784312|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784313|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784314|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784315|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784316|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784317|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784318|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784319|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784320|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784321|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784322|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784323|NCT01458574|O3|Outcome|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784324|NCT01458574|O2|Outcome|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784325|NCT01458574|O1|Outcome|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784326|NCT01458574|E3|Reported Event|Placebo|Participants received tofacitinib matched placebo tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784327|NCT01458574|E2|Reported Event|Tofacitinib 10 mg BID|Participants received tofacitinib 10 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784328|NCT01458574|E1|Reported Event|Tofacitinib 5 mg BID|Participants received tofacitinib (CP-690,550) 5 mg tablets, orally, BID for 53 weeks of double blind treatment period. Participants were followed-up for 4 weeks if withdrew from study participation.
784329|NCT01458561|B3|Baseline|Total|Total of all reporting groups
784330|NCT01458561|B2|Baseline|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784331|NCT01458561|B1|Baseline|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784332|NCT01458561|P2|Participant Flow|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784333|NCT01458561|P1|Participant Flow|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784334|NCT01458561|O2|Outcome|Complications/Adverse Events in Subj. Receiving Gelfoam Plus|"Number of complications/adverse events recorded for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784335|NCT01458561|O1|Outcome|Complications/Adverse Events in Subjects Receiving BioFoam|"Number of complications/adverse events recorded for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
819695|NCT01328548|B3|Baseline|Total|Total of all reporting groups
784393|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784336|NCT01458561|O2|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titer in Gelfoam Plus Sub|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784337|NCT01458561|O1|Outcome|Anti-Bovine Serum Albumin (Anti-BSA) Titers in BioFoam Subj|"Evaluation of anti-bovine serum albumin (anti-BSA) antibodies in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784338|NCT01458561|O2|Outcome|# of Gelfoam Plus Subj. Requiring Hospitalization/Intervention|"Number of subjects receiving Gelfoam Plus as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784339|NCT01458561|O1|Outcome|# of BioFoam Subjects Requiring Hospitalization/Intervention|"Number of subjects receiving BioFoam Surgical Matrix as a surgical adjunct that required hospitalization or intervention following final wound closure through the 2 year follow-up visit~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784340|NCT01458561|O2|Outcome|Length of Hospital Stay for Gelfoam Plus Subjects|"Length of hospital stay for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784341|NCT01458561|O1|Outcome|Length of Hospital Stay for BioFoam Surgical Matrix Subjects|"Length of hospital stay for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784342|NCT01458561|O2|Outcome|Core Body Temp of Gelfoam Plus During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784343|NCT01458561|O1|Outcome|Core Body Temp of BioFoam Subjects During Hemostat Application|"Core body temp during prescribed topical hemostat application for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784344|NCT01458561|O2|Outcome|Total Time of Procedure for Gelfoam Plus Subjects|"Total time of procedure for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784345|NCT01458561|O1|Outcome|Total Time of Procedure for BioFoam Surgical Matrix Subjects|"Total time of procedure for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784346|NCT01458561|O2|Outcome|Gelfoam Plus Subj. Requiring Reop. Due to Bleeding/Bili. Leak|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784347|NCT01458561|O1|Outcome|BioFoam Subj. Requiring Reop. Due to Bleeding/Biliary Leakage|"Number of subjects requiring reoperation due to bleeding and/or biliary leakage in subjects who received BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784348|NCT01458561|O2|Outcome|Presence of Device Via MRI in Gelfoam Plus Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784349|NCT01458561|O1|Outcome|Presence of Device Via MRI in BioFoam Surgical Matrix Subjects|"Evaluation for presence of device via magnetic resonance imaging (MRI) in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784350|NCT01458561|O2|Outcome|Laboratory Evaluations for Gelfoam Plus Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784351|NCT01458561|O1|Outcome|Laboratory Evaluations for BioFoam Subjects Out of Range|"Number of out of range lab evaluations for subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784352|NCT01458561|O2|Outcome|Amt. of Intraop. Blood Products Rec'd by Gelfoam Plus Subjects|"Amount of blood products administered intraoperatively to subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784353|NCT01458561|O1|Outcome|Amt. of Intraop. Blood Products Rec'd by BioFoam Subjects|"Amount of blood products administered intraoperatively to subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784354|NCT01458561|O2|Outcome|Duration of Postoperative Drainage in Gelfoam Plus Subjects|"Duration of postoperative drainage in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784355|NCT01458561|O1|Outcome|Duration of Postoperative Drainage in BioFoam Subjects|"Duration of postoperative drainage in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784356|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784357|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784358|NCT01458561|O2|Outcome|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784359|NCT01458561|O1|Outcome|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784360|NCT01458561|O2|Outcome|Intraop. Blood Loss in Gelfoam Plus Subjects|"Amount of blood lost intraoperatively in subjects receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784361|NCT01458561|O1|Outcome|Intraop. Blood Loss in BioFoam Surgical Matrix Subjects|"Amount of blood lost intraoperatively in subjects receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784844|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784362|NCT01458561|O2|Outcome|Achievement of Immediate Hemostasis in Gelfoam Plus Subjects|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784363|NCT01458561|O1|Outcome|Achieve Immediate Hemostasis in BioFoam Subjects/Participants|"Number of subjects achieving immediate hemostasis (1 minute following application of hemostatic agent) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784364|NCT01458561|O2|Outcome|Subjects/Participants Receiving Gelfoam Plus|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784365|NCT01458561|O1|Outcome|Subjects/Participants Receiving BioFoam|"Number of subjects achieving hemostasis (y/n) at predetermined time points (1, 3, 5, 7, 10 min) in subjects/participants receiving BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784366|NCT01458561|O2|Outcome|Control Bleeding in Gelfoam Plus Subjects/Participants|"Control of bleeding in subjects/participants who receive Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784367|NCT01458561|O1|Outcome|Control Bleeding in BioFoam Subjects/Participants|"Control of bleeding in subjects/participants who receive BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784368|NCT01458561|E2|Reported Event|Gelfoam Plus|"Control of bleeding using Gelfoam Plus as a surgical adjunct~Gelfoam Plus : Surgical adjunct in control of bleeding in open liver surgery"
784369|NCT01458561|E1|Reported Event|BioFoam Surgical Matrix|"Control of bleeding using BioFoam Surgical Matrix as a surgical adjunct~BioFoam Surgical Matrix : Surgical adjunct to control bleeding in open liver surgery"
784370|NCT01458535|B7|Baseline|Total|Total of all reporting groups
784371|NCT01458535|B6|Baseline|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784372|NCT01458535|B5|Baseline|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784373|NCT01458535|B4|Baseline|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784374|NCT01458535|B3|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784375|NCT01458535|B2|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784376|NCT01458535|B1|Baseline|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784377|NCT01458535|P6|Participant Flow|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784378|NCT01458535|P5|Participant Flow|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784379|NCT01458535|P4|Participant Flow|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784380|NCT01458535|P3|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784381|NCT01458535|P2|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784382|NCT01458535|P1|Participant Flow|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve genotype 1 participants.
784383|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784384|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784385|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784386|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784387|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784388|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784389|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784390|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784391|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784392|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784845|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784394|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784395|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784396|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784397|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784398|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784399|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784400|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784401|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784402|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784403|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784404|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784405|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784406|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784407|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784408|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784409|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784410|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784411|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784412|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784413|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784414|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784415|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784416|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784417|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784418|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784419|NCT01458535|O6|Outcome|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 3 participants.
784420|NCT01458535|O5|Outcome|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 2 participants.
784421|NCT01458535|O4|Outcome|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve genotype 1 participants.
784422|NCT01458535|O3|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 3 participants.
784423|NCT01458535|O2|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 2 participants.
784424|NCT01458535|O1|Outcome|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve genotype 1 participants.
784425|NCT01458535|E6|Reported Event|ABT-450/r and ABT-267 in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
784426|NCT01458535|E5|Reported Event|ABT-450/r and ABT-267 in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.
784427|NCT01458535|E4|Reported Event|ABT-450/r and ABT-267 in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.
784428|NCT01458535|E3|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 3 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.
784429|NCT01458535|E2|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 2 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.
784430|NCT01458535|E1|Reported Event|ABT-450/r and ABT-267 Plus RBV in Genotype 1 Participants|ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.
784431|NCT01458288|B1|Baseline|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
784432|NCT01458288|P1|Participant Flow|TG-0054 (3.14 mg/kg TG-0054 Administrated Via 15-min IV Infus)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
784433|NCT01458288|O2|Outcome|TG-0054 (3.14 mg/kg)+G-CSF|Patients followed administration of TG-0054 (3.14 mg/kg) combined with granulocyte colony-stimulating factor (G-CSF) and leukapheresis start from study day 8.
784434|NCT01458288|O1|Outcome|TG-0054 (3.14 mg/kg)|Patients followed administration of TG-0054 (3.14 mg/kg) alone and leukapheresis start from study day 1.
784435|NCT01458288|E1|Reported Event|TG-0054 (3.14 mg/kg Administrated Via 15-min IV Infusion)|"TG-0054 (3.14 mg/kg)~TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)"
784436|NCT01458275|B4|Baseline|Total|Total of all reporting groups
784437|NCT01458275|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784438|NCT01458275|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784439|NCT01458275|B1|Baseline|Placebo|Placebo: Placebo - one actuation per nostril
784440|NCT01458275|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784441|NCT01458275|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784442|NCT01458275|P1|Participant Flow|Placebo|Placebo: Placebo - one actuation per nostril
784443|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784444|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784445|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784446|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784447|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784448|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784449|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784450|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784451|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784452|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784453|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784454|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784455|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784456|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784457|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784458|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784459|NCT01458275|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784460|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784461|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784462|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784463|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784464|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784465|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784466|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784467|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784469|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784470|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784471|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784472|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784473|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784474|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784475|NCT01458275|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784476|NCT01458275|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784477|NCT01458275|O1|Outcome|Placebo|Placebo: Placebo - one actuation per nostril
784478|NCT01458275|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
784479|NCT01458275|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
784480|NCT01458275|E1|Reported Event|Placebo|Placebo: Placebo - one actuation per nostril
784481|NCT01458249|B3|Baseline|Total|Total of all reporting groups
784482|NCT01458249|B2|Baseline|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784483|NCT01458249|B1|Baseline|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784484|NCT01458249|P1|Participant Flow|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
784485|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784486|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784487|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784488|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784489|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784490|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784491|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784492|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784493|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784494|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784495|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784496|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784497|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784846|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784498|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784499|NCT01458249|O2|Outcome|Arm 2: Participants With OTH|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Other types of eligible soft tissue sarcoma (OTH)
784500|NCT01458249|O1|Outcome|Arm 1: Participants With ADI or LMS|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks). Adipocyte sarcoma (ADI) or Leiomyosarcoma (LMS)
784501|NCT01458249|E1|Reported Event|All Treated Participants (Arm 1 and Arm 2)|Eribulin mesylate was administered at a dose of 1.4 mg/m^2 as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days (3 weeks).
784502|NCT01458210|B1|Baseline|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784503|NCT01458210|P1|Participant Flow|Overall Study|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784504|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784505|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
784506|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784507|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
784508|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784509|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
784510|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784531|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
784532|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
784533|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
826666|NCT01305044|B3|Baseline|Total|Total of all reporting groups
784511|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
784512|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784513|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
784514|NCT01458210|O2|Outcome|Ortho-Cyclen + Dulaglutide (Period 2)|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 2 sample was taken during the second 28-day course.~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784515|NCT01458210|O1|Outcome|Ortho-Cyclen Alone (Period 1)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively). Following the Lead-in period, the Period 1 sample was taken during the first 28-day course.
784516|NCT01458210|E3|Reported Event|Ortho-Cyclen + Dulaglutide|"Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).~Dulaglutide: A single, 1.5-mg subcutaneous injection on Day 19 of Period 2."
784517|NCT01458210|E2|Reported Event|Ortho-Cyclen Alone|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in) followed by 2 subsequent 28-day courses (Periods 1 and 2, respectively).
784518|NCT01458210|E1|Reported Event|Lead-in (1st Course of Ortho-Cyclen)|Ortho-Cyclen (OC) (0.25 milligram [mg] norelgestromin [NGMN] + 0.035 mg ethinyl estradiol [EE] [active tablets] for 21 days + non-active tablets for 7 days): A 28-day course of OC consists of 0.25 mg NGMN and 0.035 mg EE (active tablets), administered orally, once per day for 21 days, then non-active tablets, administered orally, once per day for 7 days. Participants received the first 28-day course (Lead-in).
784519|NCT01458171|B1|Baseline|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
784520|NCT01458171|P1|Participant Flow|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
784521|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
784522|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
784523|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
784524|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
784525|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
784526|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
784527|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
784528|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
784529|NCT01458171|O2|Outcome|IgPro20 - PPS|The PPS comprised all subjects with the disease under study who a) received uniformly repeated IgPro20 infusions at weekly intervals and b) who had at least 1 documented total serum IgG trough level.
784530|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
784534|NCT01458171|O1|Outcome|IgPro20 - FAS|The FAS comprised all subjects receiving at least 1 IgPro20 infusion.
784535|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
784536|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
784537|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
784538|NCT01458171|O1|Outcome|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
784539|NCT01458171|E1|Reported Event|IgPro20|Immune globulin subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
784540|NCT01458106|B3|Baseline|Total|Total of all reporting groups
784541|NCT01458106|B2|Baseline|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784542|NCT01458106|B1|Baseline|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784543|NCT01458106|P2|Participant Flow|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784544|NCT01458106|P1|Participant Flow|Participants < 6 Years Old|"Pharmacokinetic (PK) subgroup: After a Washout Period of ≥72 hrs, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5±2 minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for PK assessment. Following a second Washout Period of ≥72 hrs, participants receive a single IV injection of rFVIIIFc over 5±2 mins at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784545|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784620|NCT01457950|B1|Baseline|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
785725|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
784725|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
784546|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784547|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784548|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784549|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784550|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784551|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784552|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784553|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784554|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784555|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784556|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784557|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784558|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784559|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784560|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784561|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784562|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784563|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784564|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784565|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784566|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784567|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784568|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784569|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784570|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784571|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784572|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784573|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784574|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784575|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784576|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784577|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784578|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784579|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784580|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784581|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784582|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784583|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784584|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784585|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784586|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784587|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784588|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784589|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784590|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784591|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784592|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784593|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784594|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784595|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784596|NCT01458106|O1|Outcome|Participants < 6 Years Old|PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.
784597|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784598|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784599|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784600|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784601|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784602|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784621|NCT01457950|P4|Participant Flow|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784847|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784603|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784604|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784605|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784606|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784607|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784608|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784609|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784664|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784848|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784610|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784611|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784612|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784613|NCT01458106|O3|Outcome|All Arms: Total|
784614|NCT01458106|O2|Outcome|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784615|NCT01458106|O1|Outcome|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥72 hours, at the Baseline Visit (28±7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (±2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥72 hours, participants receive a single IV injection of rFVIIIFc over 5 (±2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection is given, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784616|NCT01458106|E2|Reported Event|Participants 6 to < 12 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784617|NCT01458106|E1|Reported Event|Participants < 6 Years Old|"PK subgroup: After a Washout Period of ≥ 72 hours, at the Baseline Visit (28 ± 7 days prior to Day 1), participants receive a single IV injection of prestudy FVIII over 5 (± 2) minutes at a dose of 50 IU/kg, rounded up to the nearest 250 IU increment, for a PK assessment. Following a second Washout Period of ≥ 72 hours, participants receive a single IV injection of rFVIIIFc over 5 (± 2) minutes at a dose of 50 IU/kg for PK assessment. The first prophylactic dose of rFVIIIFc is administered at a starting dose of 25 IU/kg IV injection on Day 1 and 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated.~Non-PK subgroup: On Day 1, a first prophylactic dose of rFVIIIFc of 25 IU/kg IV injection, followed by a dose of 50 IU/kg on Day 4. Dose increases to a maximum of 80 IU/kg, and frequency of administration to a minimum interval of once every 2 days, are allowed as indicated."
784618|NCT01457950|B3|Baseline|Total|Total of all reporting groups
784619|NCT01457950|B2|Baseline|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784622|NCT01457950|P3|Participant Flow|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784623|NCT01457950|P2|Participant Flow|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784624|NCT01457950|P1|Participant Flow|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784625|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784626|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784627|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784628|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784629|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784630|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784631|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784632|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784633|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784634|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784665|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784849|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784635|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784636|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784637|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784638|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784639|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784640|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784641|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784642|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784643|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784644|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784645|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784646|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784647|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784648|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784649|NCT01457950|O2|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784650|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784651|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784652|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784653|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784654|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784655|NCT01457950|O1|Outcome|Placebo to Open-Label Denosumab 60 mg|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784656|NCT01457950|O1|Outcome|Denosumab 60 mg to Open-Label Denosumab 60mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784657|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784658|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784659|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784660|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784661|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784662|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784663|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784828|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784666|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784667|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784668|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784669|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784670|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784671|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784672|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784673|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784674|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784675|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784676|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784677|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784678|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784679|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784680|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784681|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784682|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784683|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784684|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784685|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784686|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784687|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784688|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784689|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
822064|NCT01319422|B3|Baseline|Total|Total of all reporting groups
784690|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784691|NCT01457950|O2|Outcome|Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784692|NCT01457950|O1|Outcome|Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784693|NCT01457950|E4|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Placebo)|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784694|NCT01457950|E3|Reported Event|Open Label Denosumab 60 mg (Previously Randomized Denosumab)|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]). At the end of the Double-Blind Treatment Phase, following completion of all Month 6 assessments, eligible participants entered the Open-Label Extension Phase and received a single SC injection of denosumab 60 mg and were followed up for an additional 6 months.
784695|NCT01457950|E2|Reported Event|Randomized Phase: Placebo|Participants received a matching placebo single SC injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU).
784696|NCT01457950|E1|Reported Event|Randomized Phase: Denosumab 60 mg|Participants received a denosumab 60 milligrams (mg) single subcutaneous (SC) injection at the start of the Double-Blind Treatment Phase. All participants received daily oral supplementation of elemental calcium (at least 1000 mg) and vitamin D (at least 400 International Units [IU]).
784697|NCT01457885|B1|Baseline|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
784698|NCT01457885|P1|Participant Flow|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
784699|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
784700|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
784701|NCT01457885|O1|Outcome|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
784702|NCT01457885|E1|Reported Event|CloBu4 Regimen|"After pre-conditioning with CloBu4 (Clofarabine/Busulfan x 4), subjects will receive a peripheral blood stem cell transplant~Clofarabine/Busulfan x 4: - Clofarabine IV, 40 mg/m2/day x 5 days, and Busulfan IV, 3.2 mg/kg daily x 4 days"
784703|NCT01457846|B3|Baseline|Total|Total of all reporting groups
784704|NCT01457846|B2|Baseline|AZD4547|80mg BD 2 weeks on/1 week off
784705|NCT01457846|B1|Baseline|Paclitaxel|80mg / m^2
784706|NCT01457846|P2|Participant Flow|Paclitaxel|80mg / m^2
784707|NCT01457846|P1|Participant Flow|AZD4547|80mg BD 2 weeks on/1 week off
784708|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
784709|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
784710|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
784711|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
784712|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
784713|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
784714|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
784715|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
784716|NCT01457846|O2|Outcome|Paclitaxel|80mg / m^2
784717|NCT01457846|O1|Outcome|AZD4547|80mg BD 2 weeks on/1 week off
784718|NCT01457846|E2|Reported Event|Paclitaxel|80mg / m^2
784719|NCT01457846|E1|Reported Event|AZD4547|80mg BD 2 weeks on/1 week off
784720|NCT01457703|B3|Baseline|Total|Total of all reporting groups
784721|NCT01457703|B2|Baseline|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784722|NCT01457703|B1|Baseline|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784723|NCT01457703|P2|Participant Flow|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784724|NCT01457703|P1|Participant Flow|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784829|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784726|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
784727|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784728|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784729|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
784730|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
784731|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
784732|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~GnRH or gonadorelin (Lutrepulse) and Letrozole were administered in Aim 2. Description: comparative study of pathophysiology"
784733|NCT01457703|O2|Outcome|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784734|NCT01457703|O1|Outcome|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784735|NCT01457703|E2|Reported Event|BMI 18-25 kg/m2|"BMI 18-25 kg/m2~History of regular menstrual cycles every 25-35 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784736|NCT01457703|E1|Reported Event|BMI ≥30 kg/m2|"BMI ≥30 kg/m2~History of regular menstrual cycles every 25-40 days~Letrozole, Gonadorelin-GnRH, Luveris-lutropin, cetrorelix: Reproductive Hormonal Alterations in Obesity, Aims #1 and 2 Description: comparative study of pathophysiology"
784737|NCT01457521|B3|Baseline|Total|Total of all reporting groups
784738|NCT01457521|B2|Baseline|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
784739|NCT01457521|B1|Baseline|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
784740|NCT01457521|P2|Participant Flow|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
784741|NCT01457521|P1|Participant Flow|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
784742|NCT01457521|O2|Outcome|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
784743|NCT01457521|O1|Outcome|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
784744|NCT01457521|E2|Reported Event|Therapeutic|Ibuprofen 800 mg every 4-6 hours as needed starting at the onset of pain. The maximum dose is 3,200 mg per 24 hour period.
784745|NCT01457521|E1|Reported Event|Prophylactic|Ibuprofen 800 mg starting 1 hour before the misoprostol dose and continuing every 4-6 hours for 48 hours regardless of pain, then as needed. The maximum dose is 3,200 mg per 24 hour period.
784746|NCT01457430|B1|Baseline|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
784747|NCT01457430|P1|Participant Flow|Icatibant|Icatibant: 30 mg subcutaneous dose of Icatibant
784748|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
784749|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
784750|NCT01457430|O2|Outcome|Icatibant Treatment by Self Administration|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by self administration.
784751|NCT01457430|O1|Outcome|Icatibant Treatment With Health Care Provider|Icatibant: 30 mg subcutaneous dose of Icatibant given to treat an acute attack of HAE by a health care provider.
784752|NCT01457430|E1|Reported Event|Icatibant|"Open-label study~Icatibant: 30 mg subcutaneous dose of Icatibant"
784753|NCT01457417|B6|Baseline|Total|Total of all reporting groups
784754|NCT01457417|B5|Baseline|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784755|NCT01457417|B4|Baseline|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784830|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784851|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784852|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784756|NCT01457417|B3|Baseline|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784757|NCT01457417|B2|Baseline|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784758|NCT01457417|B1|Baseline|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784759|NCT01457417|P5|Participant Flow|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784760|NCT01457417|P4|Participant Flow|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784761|NCT01457417|P3|Participant Flow|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784762|NCT01457417|P2|Participant Flow|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784763|NCT01457417|P1|Participant Flow|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784764|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784765|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784766|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784831|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784767|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784768|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784769|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784770|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784771|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784772|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784773|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784774|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784775|NCT01457417|O1|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784776|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784777|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784832|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784850|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784778|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784779|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784780|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784781|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784782|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784783|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784784|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784785|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784786|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784787|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784833|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784834|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784835|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784788|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784789|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784790|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784791|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784792|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784793|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784794|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784795|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784796|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784797|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784836|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784837|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784838|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
785012|NCT01456962|B3|Baseline|Total|Total of all reporting groups
784798|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784799|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784800|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784801|NCT01457417|O6|Outcome|Total|Total across all treatment groups
784802|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784803|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784804|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784805|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784806|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784807|NCT01457417|O6|Outcome|Total|Total across all treatment groups
784808|NCT01457417|O5|Outcome|300 mg DKN-01 Part B (Q2W)|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784809|NCT01457417|O4|Outcome|600 mg DKN-01 Part A (Q2W)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784839|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784840|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784810|NCT01457417|O3|Outcome|300 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784811|NCT01457417|O2|Outcome|150 mg DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784812|NCT01457417|O1|Outcome|75 Milligram (mg) DKN-01 Part A (QW)|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784813|NCT01457417|E5|Reported Event|300 mg DKN-01 Part B|Dose Confirmation: Once the MTD had been established or the highest planned dose level completed, 300 mg of DKN-01 was administered as IV on days 1 and 15 of every 28 day cycle.
784814|NCT01457417|E4|Reported Event|600 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784815|NCT01457417|E3|Reported Event|300 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) was met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784816|NCT01457417|E2|Reported Event|150 mg DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method will be guided by the incidence of DLTs during the first cycle.
784817|NCT01457417|E1|Reported Event|75 Milligram (mg) DKN-01 Part A|DKN-01: DKN-01 was administered intravenously (IV) once a week over a minimum of 30 minutes and up to a maximum of 2 hours for dose levels of 75 mg, 150 mg and 300 mg. At the 600 mg dose level, DKN-01 was administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: Study group of 3 participants were treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation occurred sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching the maximum tolerated dose (MTD) were met or the highest planned dose study group was completed. Cycle 1 defined the dose limiting toxicity (DLT) period that governs dose escalation. The dose escalation method was guided by the incidence of DLTs during the first cycle.
784818|NCT01457339|B3|Baseline|Total|Total of all reporting groups
784819|NCT01457339|B2|Baseline|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784820|NCT01457339|B1|Baseline|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
784821|NCT01457339|P2|Participant Flow|SPD489 (Lisdexamfetamine Dimesylate)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784822|NCT01457339|P1|Participant Flow|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
784823|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784824|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784825|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784826|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784827|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784853|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784854|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784855|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784856|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784857|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784858|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784859|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784860|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784861|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784862|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784863|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784864|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784865|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784866|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784867|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784868|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784869|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784870|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784871|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784872|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784873|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784874|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784875|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784876|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784877|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784878|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784879|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784880|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784881|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784882|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784883|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784884|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784885|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784886|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784887|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784888|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784889|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784890|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784891|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784892|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784893|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784894|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784895|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784896|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784897|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784898|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784899|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784900|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784901|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784902|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784903|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784904|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784905|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784906|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
824408|NCT01312844|B3|Baseline|Total|Total of all reporting groups
784907|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784908|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784909|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784910|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784911|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784912|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784913|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784914|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784915|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784916|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784917|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784918|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784919|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784920|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784921|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784922|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784923|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784924|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784925|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784926|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784927|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784928|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784929|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784930|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784931|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784932|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784933|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784934|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784935|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784936|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784937|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784938|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784939|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784940|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784941|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784942|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784943|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784944|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784945|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784946|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784947|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784948|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784949|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784950|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784951|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784952|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784953|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784954|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784955|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784956|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784957|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784958|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784959|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784960|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784961|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784962|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784963|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784964|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784965|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784966|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784967|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Oral 250 mg dose of SPD489 administered once daily for 5 days.
784968|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Oral 200 mg dose of SPD489 administered once daily for 5 days.
784969|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Oral 150 mg dose of SPD 489 administered once daily for 5 days.
784970|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784971|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784972|NCT01457339|O1|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784973|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Oral 100 mg dose of SPD489 administered once daily for 5 days.
784974|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784975|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Oral 70 mg dose of SPD489 administered once daily for 5 days.
784976|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784977|NCT01457339|O2|Outcome|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Oral 50 mg dose of SPD489 administered once daily for 5 days.
784978|NCT01457339|O1|Outcome|Placebo|Placebo Capsule(s) for oral use taken once daily for 5 days
784979|NCT01457339|E8|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(All Doses)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784980|NCT01457339|E7|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(250 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784981|NCT01457339|E6|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(200 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784982|NCT01457339|E5|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(150 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784983|NCT01457339|E4|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(100 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784984|NCT01457339|E3|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(70 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784985|NCT01457339|E2|Reported Event|SPD489 (Lisdexamfetamine Dimesylate)(50 mg)|Ascending multiple, oral doses of SPD489 (50mg, 70mg, 100mg, 150mg, 200mg, 250mg) administered once daily for 5 days at each dose level (30 days total).
784986|NCT01457339|E1|Reported Event|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
784987|NCT01457053|B1|Baseline|All Study Participants|2 subjects completed the study. 2 subjects did not complete either arm and did not have usable data.
784988|NCT01457053|P2|Participant Flow|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
784989|NCT01457053|P1|Participant Flow|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
784990|NCT01457053|O2|Outcome|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
785013|NCT01456962|B2|Baseline|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
785186|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785014|NCT01456962|B1|Baseline|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
784991|NCT01457053|O1|Outcome|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
784992|NCT01457053|E2|Reported Event|Diuretic Therapy|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretic therapy. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Loop diuretics (furosemide, torsemide, bumetanide): Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
784993|NCT01457053|E1|Reported Event|Ultrafiltration|"Patients with acute decompensated heart failure will be randomized to either ultrafiltration or diuretics. The myocardial blood flow of patients treated with ultrafiltration will be actively compared to diuretic therapy.~Ultrafiltration: Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
784994|NCT01457014|B1|Baseline|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
784995|NCT01457014|P4|Participant Flow|Servo Ventilation Manual (Manual SV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
784996|NCT01457014|P3|Participant Flow|Servo Ventilation Auto Mode (autoSV)|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
784997|NCT01457014|P2|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
784998|NCT01457014|P1|Participant Flow|Diagnostic Polysomnography (PSG)|A Diagnostic PSG was performed using the core equipment available to determine eligibility into the overnight portion of the study.
784999|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
785000|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
785001|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
785002|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
785003|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
785004|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
785005|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
785006|NCT01457014|O1|Outcome|Diagnostic PSG|Baseline overnight PSG.
785007|NCT01457014|O4|Outcome|Servo Ventilation Manual|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device with mandatory minimal inspiratory minus expiratory pressure difference.~servo ventilation manual: servo ventilation titrated in manual mode"
785008|NCT01457014|O3|Outcome|Servo Ventilation Auto Mode|"Inspiratory and expiratory pressures automatically determined by the servo ventilation device.~servo ventilation auto: Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
785009|NCT01457014|O2|Outcome|CPAP|"Airway pressure delivered at a constant pressure level.~CPAP: continuous positive airway pressure~servo ventilation manual: servo ventilation titrated in manual mode"
785010|NCT01457014|O1|Outcome|Diagnostic Polysomnography (PSG)|Baseline overnight Polysomnography (PSG)
785011|NCT01457014|E1|Reported Event|Total Group|34 subjects completed part 1 of the study which consisted of diagnostic PSG screening and met all inclusion/exclusion criteria
785015|NCT01456962|P2|Participant Flow|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
785016|NCT01456962|P1|Participant Flow|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL) with a CD4+ T-cells/mm3 >300 and HIV RNA copies/mL <48 for a minimum of 6 months.
785017|NCT01456962|O2|Outcome|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
785018|NCT01456962|O1|Outcome|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
785019|NCT01456962|E2|Reported Event|Atazanavir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with ritonavir (RIT)-boosted atazanavir (ATZ)
785020|NCT01456962|E1|Reported Event|Raltegravir Group|HIV-1-infected women on a regimen of tenofovir (TDF) and emtricitabine (FTC) with raltegravir (RAL)
785021|NCT01456936|B5|Baseline|Total|Total of all reporting groups
785022|NCT01456936|B4|Baseline|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785023|NCT01456936|B3|Baseline|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785024|NCT01456936|B2|Baseline|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785025|NCT01456936|B1|Baseline|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785026|NCT01456936|P4|Participant Flow|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785027|NCT01456936|P3|Participant Flow|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785028|NCT01456936|P2|Participant Flow|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785029|NCT01456936|P1|Participant Flow|Varenicline|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg daily once (QD) x 3 days, 0.5 mg twice daily (BID) x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785030|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785031|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785032|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785033|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785034|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785173|NCT01456169|P3|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785187|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785188|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785035|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785036|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785037|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785038|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785039|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785040|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785041|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785042|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785043|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785044|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785045|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785046|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785047|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785048|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785049|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785050|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785174|NCT01456169|P2|Participant Flow|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785175|NCT01456169|P1|Participant Flow|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785051|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785052|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785053|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785054|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785055|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785056|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785057|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785058|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785059|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785060|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785061|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785062|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785063|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785064|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785065|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785066|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785176|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785177|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785067|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785068|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785069|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785070|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785071|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785072|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785073|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785074|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785075|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785076|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785077|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785078|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785079|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785080|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785081|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785082|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785178|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785179|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785083|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785084|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785085|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785086|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785087|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785088|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785089|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785090|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785091|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785092|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785093|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785094|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785095|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785096|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785097|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785098|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785180|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785181|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785099|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785100|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785101|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785102|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785103|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785104|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785105|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785106|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785107|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785108|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785109|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785110|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785111|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785112|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785113|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785114|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785182|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785183|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785115|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785116|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785117|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785118|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785119|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785120|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785121|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785122|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785123|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785124|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785125|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785126|NCT01456936|O4|Outcome|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785127|NCT01456936|O3|Outcome|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785128|NCT01456936|O2|Outcome|Bupropion 150 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785129|NCT01456936|O1|Outcome|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785130|NCT01456936|E4|Reported Event|Placebo|Participants received matching placebo for varenicline, bupropion, and NRT in this triple-dummy design, and followed the same titration and dosing schedule as for the active treatments noted above.
785184|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785185|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785131|NCT01456936|E3|Reported Event|NRT Patch|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received NRT started active dosing the morning of the Week 1 visit and received a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment. They also received placebo varenicline and bupropion, dosed in the same manner as active medication.
785132|NCT01456936|E2|Reported Event|Bupropion|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received bupropion 150 mg QD x 3 days and taken 150 mg BID for the remainder of the treatment period (11 weeks and 4 days). They also received placebo varenicline and NRT patch, dosed in the same manner as the active medication.
785133|NCT01456936|E1|Reported Event|Varenicline 1.0 mg BID|Participants were randomized to 1 of the 3 active dosing groups that took active medication of either varenicline, bupropion, NRT in this triple-dummy design. Participants in this arm received varenicline titrated to the full dose during the first week in the following manner: 0.5 mg QD x 3 days, 0.5 mg BID x 4 days, then 1 mg BID for 11 weeks. They also received placebo bupropion and NRT patch, dosed in the same manner as the active medication.
785134|NCT01456299|B4|Baseline|Total|Total of all reporting groups
785135|NCT01456299|B3|Baseline|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
785136|NCT01456299|B2|Baseline|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
785137|NCT01456299|B1|Baseline|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
785138|NCT01456299|P3|Participant Flow|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
785139|NCT01456299|P2|Participant Flow|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
785140|NCT01456299|P1|Participant Flow|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
785141|NCT01456299|O3|Outcome|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
785142|NCT01456299|O2|Outcome|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
785143|NCT01456299|O1|Outcome|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
785144|NCT01456299|E3|Reported Event|Remifentanil 2|"The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml~remifentanil 2: Patients received no remifentanil"
785145|NCT01456299|E2|Reported Event|Remifentanil 1|"The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml~control: Patients received a normal saline only"
785146|NCT01456299|E1|Reported Event|Control|"The control group, which received an infusion of normal saline~remifentanil 1: The patients received an infusion of remifentanil"
785147|NCT01456195|B4|Baseline|Total|Total of all reporting groups
785148|NCT01456195|B3|Baseline|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
785149|NCT01456195|B2|Baseline|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
785150|NCT01456195|B1|Baseline|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
785151|NCT01456195|P3|Participant Flow|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
785152|NCT01456195|P2|Participant Flow|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
785153|NCT01456195|P1|Participant Flow|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
785154|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
785155|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
785156|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
785157|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
785158|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
785159|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
785160|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
785161|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
785162|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
785163|NCT01456195|O3|Outcome|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
785164|NCT01456195|O2|Outcome|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
785165|NCT01456195|O1|Outcome|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
785166|NCT01456195|E3|Reported Event|Fasiglifam 50 mg|Fasiglifam 50 mg, tablets, orally, once daily for up to 24 weeks.
785167|NCT01456195|E2|Reported Event|Fasiglifam 25 mg|Fasiglifam 25 mg, tablets, orally, once daily for up to 24 weeks.
785168|NCT01456195|E1|Reported Event|Placebo|Fasiglifam placebo-matching tablets, orally, once daily for up to 24 weeks.
785169|NCT01456169|B4|Baseline|Total|Total of all reporting groups
785170|NCT01456169|B3|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785171|NCT01456169|B2|Baseline|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785172|NCT01456169|B1|Baseline|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785189|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785190|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785191|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785192|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785193|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785194|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785195|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785196|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785197|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785198|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785199|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785200|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785201|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785202|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785203|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785204|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785205|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785206|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785207|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785208|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785209|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785210|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785211|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785212|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785213|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785214|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785215|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785216|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785217|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785218|NCT01456169|O3|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
785219|NCT01456169|O2|Outcome|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
785220|NCT01456169|O1|Outcome|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
785221|NCT01456169|E4|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/25 mg|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
785222|NCT01456169|E3|Reported Event|Azilsartan Medoxomil + Chlorthalidone 40/12.5 mg|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
785223|NCT01456169|E2|Reported Event|Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks during the Double-Blind Treatment Period.
785224|NCT01456169|E1|Reported Event|Monotherapy: Azilsartan Medoxomil 40 mg|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for 4 weeks during the Single-Blind Monotherapy Treatment Period. All enrolled participants, including those who were not randomized to double-blind treatment are included in this group.
785225|NCT01456143|B1|Baseline|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
827075|NCT01303224|B1|Baseline|Ibodutant 1 mg|oral tablet, once daily
785226|NCT01456143|P1|Participant Flow|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
785227|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
785228|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
785229|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
785230|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
785231|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
785232|NCT01456143|O1|Outcome|HRME With Proflavine|High Resolution Microendoscopy (HRME) imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer. 0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa. HRME is used to capture images of suspicious areas sprayed with proflavine hemisulfate.
785233|NCT01456143|E1|Reported Event|HRME With Proflavine Hemisulfate|High Resolution Microendoscopy imaging device used in conjunction with proflavine hemisulfate as a contrast agent
785234|NCT01456130|B1|Baseline|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
785235|NCT01456130|P1|Participant Flow|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
785236|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
785237|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
785238|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
785239|NCT01456130|O1|Outcome|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
785240|NCT01456130|E1|Reported Event|Alogliptin|Alogliptin 25 mg (or 12.5 mg for participants with moderate renal dysfunction) tablets, orally once daily and a rapid-acting insulin secretagogue as prescribed by the Investigator for up to 52 weeks.
785241|NCT01456052|B4|Baseline|Total|Total of all reporting groups
785242|NCT01456052|B3|Baseline|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
785243|NCT01456052|B2|Baseline|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
785244|NCT01456052|B1|Baseline|Placebo|Placebo: Matching placebo administered orally
785245|NCT01456052|P3|Participant Flow|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
785246|NCT01456052|P2|Participant Flow|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
785247|NCT01456052|P1|Participant Flow|Placebo|Placebo: Matching placebo administered orally
785248|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
785249|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
785250|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
785251|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
785252|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
785253|NCT01456052|O1|Outcome|Placebo|Placebo: Matching placebo administered orally
785254|NCT01456052|O3|Outcome|Placebo|Placebo: Matching placebo administered orally
785255|NCT01456052|O2|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
785256|NCT01456052|O1|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
785257|NCT01456052|O3|Outcome|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
825160|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
785258|NCT01456052|O2|Outcome|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
785260|NCT01456052|E3|Reported Event|High Dose LX1606|500 mg LX1606 TID: 500 mg LX1606 administered orally three times daily
785261|NCT01456052|E2|Reported Event|Low Dose LX1606|500 mg LX1606 QD: 500 mg LX1606 administered orally once daily
785262|NCT01456052|E1|Reported Event|Placebo|Placebo: Matching placebo administered orally
785263|NCT01456039|B4|Baseline|Total|Total of all reporting groups
785264|NCT01456039|B3|Baseline|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785265|NCT01456039|B2|Baseline|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785266|NCT01456039|B1|Baseline|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785267|NCT01456039|P3|Participant Flow|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785268|NCT01456039|P2|Participant Flow|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785269|NCT01456039|P1|Participant Flow|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785270|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785271|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785272|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785273|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785274|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785275|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785276|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785277|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785278|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785279|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785280|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785281|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785282|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785283|NCT01456039|O1|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785284|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785285|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785286|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785287|NCT01456039|O3|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785288|NCT01456039|O2|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785289|NCT01456039|O1|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785290|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785291|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785292|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785293|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785294|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785295|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785296|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785297|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785298|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785299|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785300|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785301|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785302|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785303|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785304|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
829225|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
785305|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785306|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785307|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785308|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785309|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785310|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785311|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785312|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785313|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785314|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785315|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785316|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785317|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785318|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785319|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785320|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785321|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785322|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785323|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785324|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785325|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785326|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785327|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785328|NCT01456039|O4|Outcome|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785329|NCT01456039|O3|Outcome|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785330|NCT01456039|O2|Outcome|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785331|NCT01456039|O1|Outcome|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785332|NCT01456039|O2|Outcome|Phase 1: Cohort 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785333|NCT01456039|O1|Outcome|Phase 1: Cohort 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785334|NCT01456039|E4|Reported Event|Total: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785335|NCT01456039|E3|Reported Event|Phase 2: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785336|NCT01456039|E2|Reported Event|Phase 1: Romidepsin 14mg/m^2|Romidepsin 14mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle.
785337|NCT01456039|E1|Reported Event|Phase 1: Romidepsin 9mg/m^2|Romidepsin 9mg/m^2 by intravenous (IV) infusion on Days 1, 8, 15 of each 28-day cycle
785338|NCT01456000|B3|Baseline|Total|Total of all reporting groups
785339|NCT01456000|B2|Baseline|Control Arm Ablation|"Treatment with standard ablation. Randomized and treated cohort.~Control Arm Ablation: Treatment with standard radiofrequency (RF) ablation."
785340|NCT01456000|B1|Baseline|EAS-AC (HeartLight)|"Treatment with the EAS-AC. Randomized and treated cohort.~EAS-AC (HeartLight): Pulmonary vien isolation"
785341|NCT01456000|P2|Participant Flow|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
785342|NCT01456000|P1|Participant Flow|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
785343|NCT01456000|O2|Outcome|Control Arm Ablation|"Treatment with standard ablation and evaluable for efficacy.~Control Arm Ablation: Treatment with standard ablation."
785344|NCT01456000|O1|Outcome|EAS-AC (HeartLight)|"Treatment with the EAS-AC and evaluable for efficacy.~EAS-AC (HeartLight): Pulmonary vien isolation"
785345|NCT01456000|E2|Reported Event|Control Arm Ablation|"Treatment with standard ablation.~Control Arm Ablation: Treatment with standard ablation.~ITT Population 175 Participants"
785346|NCT01456000|E1|Reported Event|EAS-AC (HeartLight)|"Treatment with the EAS-AC.~EAS-AC (HeartLight): Pulmonary vien isolation~ITT Population 178 participants"
785347|NCT01455545|B1|Baseline|Asthmatic Patients|"Patient group with bad control defined as participants with an Asthma Control Test (ACT) score = or < 19. Patient group with good control defined as participants with an Asthma Control Test (ACT)score > 19.~In both groups there were patients with mild, moderate and severe asthma according the Global Initiative for Asthma (GINA)."
829226|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
785348|NCT01455545|P2|Participant Flow|Good Control|Patient group with good control defined as participants with an Asthma Control Test (ACT)> 19 points.
785349|NCT01455545|P1|Participant Flow|Bad Control|Patient group with bad control defined as participants with an Asthma Control Test (ACT) = or < 19 points.
785350|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
785351|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
785352|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
785353|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
785354|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19 .
785355|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
785356|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
785357|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
785358|NCT01455545|O2|Outcome|Good Control|Patients with asthma and goog control. Good control if ACT score > 19.
785359|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control. Bad control if ACT score < or = 19.
785360|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
785361|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
785362|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
785363|NCT01455545|O1|Outcome|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19.
785364|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
785365|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
785366|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19 .
785367|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19.
785368|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control if ACT score > 19.
785369|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
785370|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
785371|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test (ACT). Bad control if ACT score < or = 19 .
785372|NCT01455545|O2|Outcome|Good Control|Patients with asthma and good control evaluated by Asthma Control Test (ACT). Good control if ACT score > 19.
785373|NCT01455545|O1|Outcome|Bad Control|Patients with asthma and bad control evaluated by Asthma Control Test. Bad control if ACT score < or = 19 .
785374|NCT01455545|E2|Reported Event|Good Control|Patients with asthma and good control evaluated by Asthma Control Test. Good control more than 19 score.
785375|NCT01455545|E1|Reported Event|Bad Control Asthmatic Patients|Patients with asthma and bad control evaluated by Asthma Control Test. Good control less than 20 score.
785376|NCT01455519|B3|Baseline|Total|Total of all reporting groups
785377|NCT01455519|B2|Baseline|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
785378|NCT01455519|B1|Baseline|Sugar Pill|Subjects may receive a pill with no medicine.
785379|NCT01455519|P2|Participant Flow|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785380|NCT01455519|P1|Participant Flow|Sugar Pill|Subjects may receive a pill with no medicine.
785381|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785382|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785402|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785531|NCT01455194|P3|Participant Flow|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785726|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785571|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785383|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785384|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785385|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785386|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785387|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785388|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785389|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785390|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785391|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785392|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785393|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785394|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785395|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785396|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785397|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785398|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785399|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785400|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785401|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785403|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785404|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785405|NCT01455519|O2|Outcome|Hydromorphone ER|Hydromorphone ER Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
785406|NCT01455519|O1|Outcome|Sugar Pill|Subjects may receive a pill with no medicine.
785407|NCT01455519|E2|Reported Event|Hydromorphone ER|"Subjects received study drug: Hydromorphone ER~Hydromorphone ER: Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used."
785408|NCT01455519|E1|Reported Event|Sugar Pill|Subjects may receive a pill with no medicine.
785409|NCT01455428|B3|Baseline|Total|Total of all reporting groups
785410|NCT01455428|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
785411|NCT01455428|B1|Baseline|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785412|NCT01455428|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
785413|NCT01455428|P1|Participant Flow|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785414|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785415|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785416|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785417|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785418|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785419|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785420|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785421|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785422|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785423|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785424|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785469|NCT01455415|P2|Participant Flow|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785425|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785426|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785427|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785428|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785429|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785430|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785431|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785432|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785433|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785434|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785435|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785436|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785437|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785438|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785439|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785440|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785441|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785442|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785443|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785444|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785445|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785446|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785523|NCT01455220|O1|Outcome|MSQOL-54, Physical (Baseline to 6 Months)|
785524|NCT01455220|O1|Outcome|Baseline to 6 Months (MSISQ-19 Scores)|All enrolled participants
785525|NCT01455220|E1|Reported Event|All Patients|no Adverse events were experienced
785447|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785448|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785449|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785450|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785451|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785452|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785453|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785454|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785455|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785456|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785457|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785458|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785459|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785460|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785461|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785462|NCT01455428|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks
785463|NCT01455428|O1|Outcome|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785464|NCT01455428|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 10 weeks.
785465|NCT01455428|E1|Reported Event|Pregabalin|Participants received 1 matching placebo capsule twice a day (BID) for 1 week (run-in period), followed by an 8-week double-blind treatment phase (1-week dose-titration phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg BID and a 7-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg BID), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg BID).
785466|NCT01455415|B3|Baseline|Total|Total of all reporting groups
785467|NCT01455415|B2|Baseline|Placebo/Pregablin|Participants were randomized to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (150 - 300 mg/day). There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785468|NCT01455415|B1|Baseline|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785526|NCT01455194|B4|Baseline|Total|Total of all reporting groups
785715|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785470|NCT01455415|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized to double-blind treatment with pregabalin for 6 weeks (150 - 300 mg/day) in period 1 followed by placebo in period 2. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785471|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785472|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785473|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785474|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785475|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785476|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785477|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785478|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785479|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785480|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785481|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785482|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785483|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785484|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785485|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785486|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785487|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785488|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785489|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785490|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785491|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785492|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785493|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785494|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785527|NCT01455194|B3|Baseline|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785528|NCT01455194|B2|Baseline|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785495|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785496|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785497|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785498|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785499|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785500|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785501|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785502|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785503|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785504|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785505|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785506|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785529|NCT01455194|B1|Baseline|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785530|NCT01455194|P4|Participant Flow|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785507|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785508|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785509|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785510|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785511|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785512|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785513|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785514|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785515|NCT01455415|O2|Outcome|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785516|NCT01455415|O1|Outcome|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785517|NCT01455415|E2|Reported Event|Placebo|The below table included data from participants while receiving placebo in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785518|NCT01455415|E1|Reported Event|Pregabalin|The below tables included data from participants while receiving pregabalin in either period of the 2-period crossover study design. This crossover study consisted of two double blind 6- week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period. There was a 2-week single-blind washout (blinded to participant) between the treatment periods. A 1-week taper was administered at the end of the second treatment period, followed by a final follow-up visit.
785519|NCT01455220|B1|Baseline|Tysabri|All patients were receiving commercial Tysabri
785520|NCT01455220|P1|Participant Flow|All Patients|
785521|NCT01455220|O1|Outcome|MSQOL-54 Total (Baseline to 6 Months)|
785522|NCT01455220|O1|Outcome|FAMS (Baseline to 6 Months)|
785532|NCT01455194|P2|Participant Flow|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period. Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785533|NCT01455194|P1|Participant Flow|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, metered dose inhaler (MDI), inhalational, twice daily for up to 3 weeks in the baseline period.
785534|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785535|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785536|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785537|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785538|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785539|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785540|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785541|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785542|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785543|NCT01455194|O4|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785544|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785545|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785546|NCT01455194|O1|Outcome|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
785547|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785548|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785549|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785550|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785551|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785552|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785553|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785554|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785555|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785556|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785557|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785558|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785559|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785560|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785561|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785562|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785563|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785564|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785565|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785566|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785567|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785568|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785569|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785570|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785572|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785573|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785574|NCT01455194|O3|Outcome|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785575|NCT01455194|O2|Outcome|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785576|NCT01455194|O1|Outcome|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785577|NCT01455194|E4|Reported Event|Treatment Period: Ciclesonide 640 mcg|Ciclesonide 320 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785578|NCT01455194|E3|Reported Event|Treatment Period: Ciclesonide 320 mcg|Ciclesonide 160 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785579|NCT01455194|E2|Reported Event|Treatment Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 52 weeks in the double blind treatment period.
785580|NCT01455194|E1|Reported Event|Baseline Period: Ciclesonide 160 mcg|Ciclesonide 80 mcg, MDI, inhalational, twice daily for up to 3 weeks in the baseline period.
785581|NCT01455181|B1|Baseline|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785582|NCT01455181|P1|Participant Flow|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785583|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785584|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785585|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785586|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785587|NCT01455181|O1|Outcome|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785588|NCT01455181|E1|Reported Event|NPSP558|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50, 75, or 100 mcg subcutaneously daily.
785589|NCT01455064|B1|Baseline|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
785590|NCT01455064|P1|Participant Flow|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
785591|NCT01455064|O1|Outcome|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
785592|NCT01455064|E1|Reported Event|Observational Group|Participants using the FreeStyle Navigator II RT-CGM for 15 days (360 hours).
785593|NCT01455012|B3|Baseline|Total|Total of all reporting groups
785594|NCT01455012|B2|Baseline|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785595|NCT01455012|B1|Baseline|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785596|NCT01455012|P2|Participant Flow|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785597|NCT01455012|P1|Participant Flow|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785598|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785599|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785600|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785601|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785727|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785728|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785602|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785603|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785604|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785605|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785606|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785607|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785608|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785609|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785610|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785611|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785612|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785613|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785614|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785615|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785616|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785617|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785716|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785717|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785718|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785618|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785619|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785620|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785621|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785622|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785623|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785624|NCT01455012|O2|Outcome|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785625|NCT01455012|O1|Outcome|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785626|NCT01455012|E2|Reported Event|Rotigotine|"Rotigotine, optimal dose (minimum dose 1 mg/24 h, maximum dose 3 mg/24 h)~Rotigotine : Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785627|NCT01455012|E1|Reported Event|Placebo|"Placebo~Placebo : Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose."
785628|NCT01454934|B3|Baseline|Total|Total of all reporting groups
785629|NCT01454934|B2|Baseline|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
785630|NCT01454934|B1|Baseline|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
785631|NCT01454934|P2|Participant Flow|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
785632|NCT01454934|P1|Participant Flow|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
785633|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
785634|NCT01454934|O1|Outcome|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
785635|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
785636|NCT01454934|O1|Outcome|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
785637|NCT01454934|O2|Outcome|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
785638|NCT01454934|O1|Outcome|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
785639|NCT01454934|E2|Reported Event|Arm B: Vinorelbine, Gemcitabine, Docetaxel, or Pemetrexed|Treatment of Physician's Choice (TPC): Vinorelbine (30 mg/m^2) was administered IV on Day 1 every 7 days, Gemcitabine (1250 mg/m^2) was administered IV on Days 1 and 8 every 21 days (or 1000 mg/m^2 IV on Days 1, 8, and 15 every 28 days), Docetaxel (75 mg/m^2) was administered IV on Day 1 every 21 days, or Pemetrexed (500 mg/m^2 ) was administered IV on Day 1 every 21 days (nonsquamous histology only).
785640|NCT01454934|E1|Reported Event|Arm A: Erubulin Mesylate|Eribulin mesylate (1.4 mg/m^2) was administered intravenously (IV) over 2 to 5 minutes on Day 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
785641|NCT01454830|B3|Baseline|Total|Total of all reporting groups
785642|NCT01454830|B2|Baseline|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785643|NCT01454830|B1|Baseline|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785644|NCT01454830|P2|Participant Flow|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785645|NCT01454830|P1|Participant Flow|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785646|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785647|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785648|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785649|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785650|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785651|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785652|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785653|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
829227|NCT01296646|O2|Outcome|Naltrexone|50 mg of naltrexone orally daily.
785654|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785655|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785656|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785657|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785658|NCT01454830|O2|Outcome|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785659|NCT01454830|O1|Outcome|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785660|NCT01454830|E2|Reported Event|Usual Care|"The comparison group, usual care, includes the standard of care delivered to all newly-diagnosed OSA persons proceeding to CPAP treatment~Usual care: Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care"
785661|NCT01454830|E1|Reported Event|Tailored|"Tailored, or individualized, intervention addressing patient education, skills training, and cognitive perceptions~Tailored: Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy"
785662|NCT01454791|B3|Baseline|Total|Total of all reporting groups
785663|NCT01454791|B2|Baseline|Placebo Followed by Diclofenac Sodium Gel|"placebo for 2 weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
785664|NCT01454791|B1|Baseline|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
785665|NCT01454791|P2|Participant Flow|Placebo Followed by Diclofenac Sodium Topical Gel|"Placebo for two weeks followed by diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
785666|NCT01454791|P1|Participant Flow|Diclofenac Sodium Topical Gel Followed by Placebo|"diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
785667|NCT01454791|O2|Outcome|Placebo|Placebo for two weeks: a placebo gel is applied 1-4 times per day
785668|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
785669|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day
785670|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
785671|NCT01454791|O2|Outcome|Placebo|Placebo for 2 weeks: a placebo gel is applied 1-4 times per day.
785672|NCT01454791|O1|Outcome|Diclofenac Sodium Topical Gel|diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks
785673|NCT01454791|E2|Reported Event|Placebo|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
785674|NCT01454791|E1|Reported Event|Diclofenac Sodium Topical Gel|"1:1 randomization to either of two treatment phases of 2 weeks duration (active-placebo or placebo-active).~diclofenac sodium topical gel: diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo~Placebo: a placebo gel is applied 1-4 times per day for two weeks."
785675|NCT01454778|B1|Baseline|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785719|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785676|NCT01454778|P1|Participant Flow|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785677|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785678|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785679|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785680|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785681|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785682|NCT01454778|O1|Outcome|Paclitaxel|"Paclitaxel: Paclitaxel coating in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785683|NCT01454778|E1|Reported Event|Paclitaxel|"Paclitaxel: Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3~Paclitaxel Dosage:~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*~not to exceed 10mg total dose"
785684|NCT01454726|B3|Baseline|Total|Total of all reporting groups
785685|NCT01454726|B2|Baseline|Control Group|receiving the Western medical treatment alone.
785686|NCT01454726|B1|Baseline|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
785687|NCT01454726|P2|Participant Flow|Control Group|receiving the Western medical treatment alone.
785688|NCT01454726|P1|Participant Flow|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
785689|NCT01454726|O2|Outcome|Control Group|receiving the Western medical treatment alone.
785690|NCT01454726|O1|Outcome|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
785691|NCT01454726|E2|Reported Event|Control Group|receiving the Western medical treatment alone.
785692|NCT01454726|E1|Reported Event|Experimental Group|receiving both Diaoshi Jifa therapy and the Western medical treatment.
785693|NCT01454583|B4|Baseline|Total|Total of all reporting groups
785694|NCT01454583|B3|Baseline|Group C|Patients without any RAS inhibition (No-RAS-I)
785695|NCT01454583|B2|Baseline|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785696|NCT01454583|B1|Baseline|Group A|Patients treated with Aliskiren (DRI)
785697|NCT01454583|P3|Participant Flow|No RAS-inhibition|Patients treated with no RAS-inhibition drugs at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
785698|NCT01454583|P2|Participant Flow|ACE-I/ARB|Patients treated with ACE-I or ARB (ARB/ACE-I) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
785699|NCT01454583|P1|Participant Flow|Aliskiren|Patients treated with Aliskiren (DRI) at baseline. In the 3rd year period, only patients with Diabetes Mellitus (DM) or Heart Failure (HF) were considered.
785700|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785701|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785702|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785703|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785704|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785705|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785706|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785707|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785708|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785709|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785710|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785711|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785712|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785713|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785714|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785730|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785731|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785732|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785733|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785734|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785735|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785736|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785737|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785738|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785739|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785740|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785741|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785742|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785743|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785744|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785745|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785746|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785747|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785748|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785749|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785750|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785751|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785752|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785753|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785754|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785755|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785756|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785757|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785758|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785759|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785760|NCT01454583|O3|Outcome|Group C|Patients without any RAS inhibition (No-RAS-I)
785761|NCT01454583|O2|Outcome|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785762|NCT01454583|O1|Outcome|Group A|Patients treated with Aliskiren (DRI)
785763|NCT01454583|E3|Reported Event|Group C|Patients without any RAS inhibition (No-RAS-I)
785764|NCT01454583|E2|Reported Event|Group B|Patients treated with ACE-I or ARB (ARB/ACE-I)
785765|NCT01454583|E1|Reported Event|Group A|Patients treated with Aliskiren (DRI)
785766|NCT01454531|B1|Baseline|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785767|NCT01454531|P1|Participant Flow|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785768|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785769|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785770|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785771|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785772|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785773|NCT01454531|O1|Outcome|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785774|NCT01454531|E1|Reported Event|AVANZ Phleum Pratense|"AVANZ Phleum pratense~AVANZ Phleum pratense: Up-dosing phase of AVANZ Phleum pratense"
785775|NCT01454505|B4|Baseline|Total|Total of all reporting groups
785776|NCT01454505|B3|Baseline|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
785777|NCT01454505|B2|Baseline|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
785778|NCT01454505|B1|Baseline|Stage A/Healthy Volunteers|AL-53817 nasal spray solution in 1 of 3 concentration doses, 1 or 2 sprays per nostril, OR Vehicle, 1 spray per nostril
785779|NCT01454505|P4|Participant Flow|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
785780|NCT01454505|P3|Participant Flow|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
785781|NCT01454505|P2|Participant Flow|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
785782|NCT01454505|P1|Participant Flow|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
785783|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
785784|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
785785|NCT01454505|O2|Outcome|Stage B/Vehicle|Vehicle nasal spray, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
785786|NCT01454505|O1|Outcome|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray to each nostril twice a day for 4 days. On Day 5, 1 spray to each nostril 60 minutes before entering the EEC.
785787|NCT01454505|O2|Outcome|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
785788|NCT01454505|O1|Outcome|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
785789|NCT01454505|E4|Reported Event|Stage B/Vehicle|Vehicle nasal spray, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
785790|NCT01454505|E3|Reported Event|Stage B/AL-53817|AL-53817 nasal spray solution, 1 spray per nostril twice a day for 4 days. On Day 5, 1 spray per nostril 60 minutes before entering the EEC.
785791|NCT01454505|E2|Reported Event|Stage A/Vehicle|Vehicle, 1 or 2 sprays per nostril, single dose
785792|NCT01454505|E1|Reported Event|Stage A/AL-53817|AL-53817 nasal spray solution in 1 of 3 concentrations, 1 or 2 sprays per nostril, single dose
785793|NCT01454414|B3|Baseline|Total|Total of all reporting groups
785794|NCT01454414|B2|Baseline|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
785795|NCT01454414|B1|Baseline|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
785796|NCT01454414|P2|Participant Flow|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
785797|NCT01454414|P1|Participant Flow|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
785798|NCT01454414|O2|Outcome|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
785799|NCT01454414|O1|Outcome|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
785800|NCT01454414|E2|Reported Event|Placebo|Uniforms sent to Insect Shield, washed and refolded (no permethrin applied).
785801|NCT01454414|E1|Reported Event|Permethrin Impregnated Uniforms|"Uniforms (including pants, shorts, shirts, socks, and hats) treated with long-lasting permethrin.~Permethrin Impregnated Uniforms: Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc."
785802|NCT01454401|B1|Baseline|LeucoPatch Treatment of Diabetic Foot Ulcers|"Weekly treatment~LeucoPatch device: weekly treatment"
785803|NCT01454401|P1|Participant Flow|LeucoPatch Treatment of Diabetic Foot Ulcers|Weekly LeucoPatch treatment of diabetic foot ulcers
785804|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
785805|NCT01454401|O1|Outcome|LeucoPatch|LeucoPatch: weekly treatment
785806|NCT01454401|E1|Reported Event|All Patients Consenting to be Enrolled in the Study.|"60 patients were included for a 2 week run-in period. If ulcer area decreased more than 40% during that time the ulcer were deemed healing and NOT included for treatment. 16 patients were excluded during the run-in period - 44 were treated. For safety analysis all patients were included"
785807|NCT01454258|B1|Baseline|Cohort|Surgical patients from 10 hospitals over a period of 13 months
785808|NCT01454258|P1|Participant Flow|Cohort|Surgical patients from 10 hospitals over a period of 13 months
785809|NCT01454258|O3|Outcome|Other Colloids|gelatine, albumin,
785810|NCT01454258|O2|Outcome|Hydroxyethyl Starch|
785811|NCT01454258|O1|Outcome|Crystalloids|
785812|NCT01454258|E1|Reported Event|Cohort|Surgical patients
785813|NCT01454063|B3|Baseline|Total|Total of all reporting groups
785814|NCT01454063|B2|Baseline|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785815|NCT01454063|B1|Baseline|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785816|NCT01454063|P2|Participant Flow|Placebo|"Placebo diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785817|NCT01454063|P1|Participant Flow|OMS302|"OMS302 diluted in Balanced Salt Solution (BSS) and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785943|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
829228|NCT01296646|O1|Outcome|Placebo|Placebo taken once daily.
785987|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
786098|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
785818|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785819|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785820|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785821|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785822|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785823|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785824|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785825|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785826|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785827|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785828|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785842|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785829|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785830|NCT01454063|O2|Outcome|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785831|NCT01454063|O1|Outcome|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785832|NCT01454063|E2|Reported Event|Placebo|"Placebo diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~Placebo: Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785833|NCT01454063|E1|Reported Event|OMS302|"OMS302 diluted in Balanced Salt Solution and administered as irrigation solution during Intraocular Lens Replacement surgery.~OMS302: OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 60.75 mM phenylephrine HCl and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product are added to a 500-mL bottle of commercially available BSS solution through a syringe filter, resulting in 4.0 mL of the drug product in the 500-mL bottle."
785834|NCT01453998|B4|Baseline|Total|Total of all reporting groups
785835|NCT01453998|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785836|NCT01453998|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785837|NCT01453998|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785838|NCT01453998|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785839|NCT01453998|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785840|NCT01453998|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785841|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785856|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785843|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785844|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785845|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785846|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785847|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785848|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785849|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785850|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785851|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785852|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785853|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785854|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785855|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785980|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
785981|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
785857|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785858|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785859|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785860|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785861|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785862|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785863|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785864|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785865|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785866|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785867|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785868|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785869|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785982|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
785983|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
785870|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785871|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785872|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785873|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785874|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785875|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785876|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785877|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785878|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785879|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785880|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785881|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785882|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785984|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
786095|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
785883|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785884|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785885|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785886|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785887|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785888|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785889|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785890|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785891|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785892|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785893|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785894|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785895|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785941|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
786096|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
785896|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785897|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785898|NCT01453998|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785899|NCT01453998|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785900|NCT01453998|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785901|NCT01453998|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the Infanrix hexa™ vaccine in the primary study and a booster dose of Infanrix hexa™ in this study, co-administered with a booster dose of Prevenar 13®. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785902|NCT01453998|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation B vaccine in the primary study and a booster dose of either GSK217744 formulation B vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785903|NCT01453998|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 12 and 15 months at the time of booster vaccination who received the GSK217744 formulation A vaccine in the primary study and a booster dose of either GSK217744 formulation A vaccine (for subjects vaccinated before Protocol Amendment 2) or Infanrix hexa™ vaccine (for subjects vaccinated after Protocol Amendment 2) in this study, coadministered with a booster dose of Prevenar 13®. The Infanrix hexa™/GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively.
785904|NCT01453946|B1|Baseline|Entocort|Entocort 6 mg/day
785905|NCT01453946|P1|Participant Flow|Entocort|Entocort 6 mg/day
785906|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
785907|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
785908|NCT01453946|O1|Outcome|Entocort|Entocort 6 mg/day
785909|NCT01453946|E1|Reported Event|Entocort|Entocort 6 mg/day
785910|NCT01453894|B3|Baseline|Total|Total of all reporting groups
785911|NCT01453894|B2|Baseline|Usual Care Control Group|Patients assigned to this arm will receive usual care.
785912|NCT01453894|B1|Baseline|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
785913|NCT01453894|P2|Participant Flow|Usual Care Control Group|Patients assigned to this arm will receive usual care.
785914|NCT01453894|P1|Participant Flow|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
785915|NCT01453894|O2|Outcome|Usual Care Control Group|Patients assigned to this arm will receive usual care.
785942|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785985|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
785916|NCT01453894|O1|Outcome|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
785917|NCT01453894|E2|Reported Event|Usual Care Control Group|Patients assigned to this arm will receive usual care.
785918|NCT01453894|E1|Reported Event|Reminder and Outreach Intervention|"Participants randomized to this arm will receive the Reminder and Outreach intervention.~Reminder and Outreach Intervention: This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results."
785919|NCT01453855|B3|Baseline|Total|Total of all reporting groups
785920|NCT01453855|B2|Baseline|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
785921|NCT01453855|B1|Baseline|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
785922|NCT01453855|P2|Participant Flow|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
785923|NCT01453855|P1|Participant Flow|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
785924|NCT01453855|O2|Outcome|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
785925|NCT01453855|O1|Outcome|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
785926|NCT01453855|E2|Reported Event|TRAVATAN|Travoprost ophthalmic solution, 0.004%, one drop instilled in each eye, once daily, for three months
785927|NCT01453855|E1|Reported Event|Travoprost 0.003%|Travoprost ophthalmic solution, 0.003%, one drop instilled in each eye, once daily, for three months
785928|NCT01453725|B3|Baseline|Total|Total of all reporting groups
785929|NCT01453725|B2|Baseline|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785930|NCT01453725|B1|Baseline|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785931|NCT01453725|P2|Participant Flow|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785932|NCT01453725|P1|Participant Flow|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785933|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785934|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785935|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785936|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785937|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785938|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785939|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785940|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785986|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
785944|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785945|NCT01453725|O2|Outcome|Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785946|NCT01453725|O1|Outcome|Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785947|NCT01453725|E4|Reported Event|Part 2: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785948|NCT01453725|E3|Reported Event|Part 2: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785949|NCT01453725|E2|Reported Event|Part 1: Placebo→Golimumab|In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)
785950|NCT01453725|E1|Reported Event|Part 1: Golimumab→Golimumab|In Part 1, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
785951|NCT01452529|B3|Baseline|Total|Total of all reporting groups
785952|NCT01452529|B2|Baseline|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
785953|NCT01452529|B1|Baseline|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
785954|NCT01452529|P3|Participant Flow|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
785955|NCT01452529|P2|Participant Flow|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
785956|NCT01452529|P1|Participant Flow|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects qualification for randomization
785957|NCT01452529|O2|Outcome|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
785958|NCT01452529|O1|Outcome|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
785959|NCT01452529|E3|Reported Event|Placebo|"Placebo to match hydrocodone bitartrate once daily tablets~Placebo to match hydrocodone bitartrate q24h tablets: Placebo to match hydrocodone bitartrate q24h film coated tablets 20 – 120 mg once daily"
785960|NCT01452529|E2|Reported Event|Hydrocodone Bitartrate|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
785961|NCT01452529|E1|Reported Event|Open-label Run-in Dose-titration Period Hydrocodone Bitartrate|The open-label run-in dose-titration period was designed to assess subjects' qualification for randomization
785962|NCT01453595|B4|Baseline|Total|Total of all reporting groups
785963|NCT01453595|B3|Baseline|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
785964|NCT01453595|B2|Baseline|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
785965|NCT01453595|B1|Baseline|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
785966|NCT01453595|P3|Participant Flow|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
785967|NCT01453595|P2|Participant Flow|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
785968|NCT01453595|P1|Participant Flow|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
785969|NCT01453595|O1|Outcome|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
785970|NCT01453595|E3|Reported Event|Cohort -1a: BEZ235 300mg|Cohort -1a: BEZ235 300mg by mouth twice daily
785971|NCT01453595|E2|Reported Event|Cohort -1: BEZ235 200mg|Cohort -1: BEZ235 200mg by mouth twice daily
785972|NCT01453595|E1|Reported Event|Cohort 1: BEZ235 400mg|Cohort 1: BEZ235 400mg by mouth twice daily
785973|NCT01453569|B4|Baseline|Total|Total of all reporting groups
785974|NCT01453569|B3|Baseline|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
785975|NCT01453569|B2|Baseline|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
785976|NCT01453569|B1|Baseline|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
785977|NCT01453569|P3|Participant Flow|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
785978|NCT01453569|P2|Participant Flow|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
785979|NCT01453569|P1|Participant Flow|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
829708|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
785988|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
785989|NCT01453569|O3|Outcome|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
785990|NCT01453569|O2|Outcome|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
785991|NCT01453569|O1|Outcome|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
785992|NCT01453569|E3|Reported Event|Placebo|Placebo: simulant of sodium oligo-mannurarate capsule
785993|NCT01453569|E2|Reported Event|Sodium Oligo-mannurarate 600mg|Sodium oligo-mannurarate 600mg: sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
785994|NCT01453569|E1|Reported Event|Sodium Oligo-mannurarate 900mg|Sodium oligo-mannurarate 900mg: sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
785995|NCT01453413|B1|Baseline|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
785996|NCT01453413|P1|Participant Flow|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
785997|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
785998|NCT01453413|O1|Outcome|People With Type 2 Diabetes|People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on Contour® Blood Glucose meter, subjects were informed of their BG value. Three subjects were excluded from all analyses due to inconsistencies in responses to inclusion / exclusion questions. So 294 subjects were included in demographics analyses.
785999|NCT01453413|E1|Reported Event|People With Type 2 Diabetes|Perceived BG value versus measured BG for people with type 2 diabetes who are in attendance at a diabetes conference
786000|NCT01453387|B3|Baseline|Total|Total of all reporting groups
786001|NCT01453387|B2|Baseline|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
786002|NCT01453387|B1|Baseline|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
786003|NCT01453387|P2|Participant Flow|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
786004|NCT01453387|P1|Participant Flow|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
786005|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
786006|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
786007|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
786008|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
786009|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg.
786010|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg.
786011|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786012|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786013|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786014|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786015|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786016|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786017|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786018|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786019|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786020|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786021|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786022|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786023|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786024|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786025|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786026|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786027|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786028|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786029|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786030|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786031|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786032|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786033|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786034|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786035|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786036|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786037|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786038|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786039|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786040|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786041|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786042|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786043|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786044|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786045|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786046|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786047|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786048|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786049|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786050|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786051|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786052|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786053|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786054|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786055|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786056|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786057|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786058|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786059|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786060|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786061|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786062|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786063|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786064|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786065|NCT01453387|O9|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 2)|MSC2015103B 200 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786066|NCT01453387|O8|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 2)|MSC2015103B 150 mcg was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786067|NCT01453387|O7|Outcome|Part 1 - MSC2015103B 1500 mcg (Schedule 1)|MSC2015103B 1500 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786068|NCT01453387|O6|Outcome|Part 1 - MSC2015103B 1000 mcg (Schedule 1)|MSC2015103B 1000 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786069|NCT01453387|O5|Outcome|Part 1 - MSC2015103B 650 mcg (Schedule 1)|MSC2015103B 650 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786070|NCT01453387|O4|Outcome|Part 1 - MSC2015103B 450 mcg (Schedule 1)|MSC2015103B 450 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786071|NCT01453387|O3|Outcome|Part 1 - MSC2015103B 300 mcg (Schedule 1)|MSC2015103B 300 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786072|NCT01453387|O2|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|MSC2015103B 200 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786073|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 150 mcg (Schedule 1)|MSC2015103B 150 mcg was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle.
786074|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786075|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
786076|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|The planned dose of MSC2015103B (150 mcg and 200 mcg) was orally administered thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle.
786077|NCT01453387|O1|Outcome|Part 1 - MSC2015103B 200 mcg (Schedule 1)|The planned dose of MSC2015103B (150 mcg, 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg) was orally administered once weekly on Days 1, 8, and 15 of a 21-day cycle.
786078|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
786079|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
786080|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
786081|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
786082|NCT01453387|O2|Outcome|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
786083|NCT01453387|O1|Outcome|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until maximum tolerated dose (MTD) was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
786084|NCT01453387|E2|Reported Event|Part 1 - MSC2015103B (Schedule 2)|MSC2015103B was administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose was 150 mcg, and was escalated to 200 mcg subsequently.
786085|NCT01453387|E1|Reported Event|Part 1 - MSC2015103B (Schedule 1)|MSC2015103B was administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD was established. Starting dose was 150 microgram (mcg), which was escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
786086|NCT01453374|B1|Baseline|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786087|NCT01453374|P1|Participant Flow|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786088|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786089|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
786090|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
786091|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786092|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786093|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786094|NCT01453374|O1|Outcome|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786097|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
827076|NCT01303224|P4|Participant Flow|Placebo|oral tablet, once daily
786099|NCT01453374|O2|Outcome|All 7 Injections|Subjects who received all 7 VIVITROL injections
786100|NCT01453374|O1|Outcome|<7 Injections|Subjects who received less than 7 VIVITROL injections
786101|NCT01453374|E1|Reported Event|VIVITROL|"380 mg IM injection~VIVITROL 380mg: 380 mg IM injection given once monthly"
786102|NCT01453348|B4|Baseline|Total|Total of all reporting groups
786103|NCT01453348|B3|Baseline|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
786104|NCT01453348|B2|Baseline|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786105|NCT01453348|B1|Baseline|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
786106|NCT01453348|P3|Participant Flow|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
786107|NCT01453348|P2|Participant Flow|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786108|NCT01453348|P1|Participant Flow|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
786109|NCT01453348|O3|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
786110|NCT01453348|O2|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786111|NCT01453348|O1|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
786112|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
786113|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786114|NCT01453348|O2|Outcome|MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
786398|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
786875|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786115|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786116|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
786117|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786118|NCT01453348|O2|Outcome|HepA/B|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
786119|NCT01453348|O1|Outcome|HepA/B+MenACWY-CRM|Subjects ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine ; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786120|NCT01453348|E3|Reported Event|ACWY|Subject ≥ 18 to ≤ 64 years of age who received one dose of MenACWY-CRM conjugate vaccine.
786121|NCT01453348|E2|Reported Event|HepA/B+ACWY|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine; all the subjects concomitantly received one dose of MenACWY-CRM conjugate vaccine.
786122|NCT01453348|E1|Reported Event|HepA/B|Subject ≥ 18 to ≤ 64 years of age who were not previously primed with hepatitis A and B vaccine received three doses of combined hepatitis A/B vaccine; subjects who were previously primed with combined hepatitis A/B received one booster dose; subjects who were previously primed with monovalent hepatitis B vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis B vaccine booster; first dose of hepatitis A vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis A vaccine; subjects who were previously primed with hepatitis A vaccine received one dose of combined hepatitis A/B vaccine on day 1 (hepatitis A vaccine booster; first dose of hepatitis B vaccine on an accelerated schedule), followed by two doses of monovalent hepatitis B vaccine.
786123|NCT01453296|B1|Baseline|VI 25 µg/Placebo or Placebo/VI 25 µg|Participants received either vilanterol (VI) 25 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by a repeat dose of the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled VI 25 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786124|NCT01453296|P2|Participant Flow|Sequence 2: Placebo Followed by VI 25 µg|Participants received placebo and VI 25 µg in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
786125|NCT01453296|P1|Participant Flow|Sequence 1: VI 25 µg Followed by Placebo|Participants received vilanterol (VI) 25 micrograms (µg) and matching placebo in Treatment Periods 1 and 2, respectively. Inhaled VI 25 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via ae Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
786126|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786127|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786128|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786129|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786130|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786131|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786132|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786133|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786134|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786135|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786136|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786137|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786138|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786139|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786140|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786141|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786142|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786143|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786144|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786145|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786146|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786147|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786148|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786393|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
786149|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786150|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786151|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786152|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786153|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786154|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786155|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786156|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786157|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786158|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786159|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786160|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786161|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786162|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786163|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786164|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786165|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786166|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786167|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786168|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786169|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786170|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786171|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786394|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
786172|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786173|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786174|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786175|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786176|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786177|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786178|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786179|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786180|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786181|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786182|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786183|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786184|NCT01453296|O2|Outcome|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786185|NCT01453296|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786186|NCT01453296|E2|Reported Event|VI 25 µg|All participants who received VI 25 µg in one or both of the 14-day treatment periods. Inhaled VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786187|NCT01453296|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786188|NCT01453166|B4|Baseline|Total|Total of all reporting groups
786189|NCT01453166|B3|Baseline|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786190|NCT01453166|B2|Baseline|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786191|NCT01453166|B1|Baseline|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786192|NCT01453166|P3|Participant Flow|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786863|NCT01451411|B1|Baseline|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786193|NCT01453166|P2|Participant Flow|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786194|NCT01453166|P1|Participant Flow|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786195|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786196|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786197|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786198|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786199|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786200|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786201|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786202|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786203|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786204|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786395|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
786864|NCT01451411|P2|Participant Flow|Placebo|Placebo: Intravenous
786205|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786206|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786207|NCT01453166|O3|Outcome|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786208|NCT01453166|O2|Outcome|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786209|NCT01453166|O1|Outcome|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786210|NCT01453166|E3|Reported Event|Heart Prevent Meal II|Group C received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
786211|NCT01453166|E2|Reported Event|Heart Prevent Meal I|Group B received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
786212|NCT01453166|E1|Reported Event|Brazilian Heart-prevent Meal|Nutrient profile of the diets used in the three groups was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, prioritizing the Brazilian culture and regional habits. All foods included in the menu were low-cost and widely available at local markets
786213|NCT01453075|B3|Baseline|Total|Total of all reporting groups
786214|NCT01453075|B2|Baseline|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
786215|NCT01453075|B1|Baseline|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
786216|NCT01453075|P2|Participant Flow|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
786217|NCT01453075|P1|Participant Flow|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
786218|NCT01453075|O2|Outcome|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
786219|NCT01453075|O1|Outcome|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
786220|NCT01453075|E2|Reported Event|Arm 2: Placebo|"Assigned patients will receiving matching placebo twice daily~Placebo: Matching placebo twice daily"
786221|NCT01453075|E1|Reported Event|Arm 1: Valacyclovir|"Assigned patients will take 1.5 mg po valacyclovir twice daily~Valacyclovir: Valacyclovir 1.5 mg po bid"
786222|NCT01453049|B3|Baseline|Total|Total of all reporting groups
786223|NCT01453049|B2|Baseline|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786237|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786865|NCT01451411|P1|Participant Flow|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786224|NCT01453049|B1|Baseline|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786225|NCT01453049|P2|Participant Flow|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786226|NCT01453049|P1|Participant Flow|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786227|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786228|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786229|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786230|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786231|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786232|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786233|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786234|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786235|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786236|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786396|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
786866|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
786238|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786239|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786240|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786241|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786242|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786243|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786244|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786245|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786246|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786247|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786248|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786249|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786250|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786397|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
786867|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786251|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786252|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786253|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786254|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786255|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786256|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786257|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786258|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786259|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786260|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786261|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786262|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786263|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786277|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786264|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786265|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786266|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786267|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786268|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786269|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786270|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786271|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786272|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786273|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786274|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786275|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786276|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786391|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
786868|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
786278|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786279|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786280|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786281|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786282|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786283|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786284|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786285|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786286|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786287|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786288|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786289|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786290|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786392|NCT01452347|O1|Outcome|Patients Evaluated|All patients treated orally with either 150mg, 220mg or 300mg of dabigatran etexilate (DE) twice daily.
786869|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786291|NCT01453049|O2|Outcome|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786292|NCT01453049|O1|Outcome|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786293|NCT01453049|E2|Reported Event|Glimepiride|Glimepiride was administered at Dose level 1 in the dose of 1 mg OD for a duration of 24 wks. In participants with FPG >=110 mg/dL after 2 or 4 wks, the investigator made a blinded increase in study medication (glim) to Dose level 2 (2 mg OD) or 3 (4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786294|NCT01453049|E1|Reported Event|Rosiglitazone+Glimepiride FDC|Fixed-dose combination (FDC) tablet of rosiglitazone (rosi) 4 milligrams (mg) and glimepiride (glim) 1 mg at Dose level 1 was administered once daily (OD) for a duration of 24 weeks (wks). In participants with fasting plasma glucose (FPG) greater than or equal to (>=) 110 mg per deciliter (dL) after 2 or 4 wks, the investigator made a blinded increase in study medication to Dose level 2 (rosi/glim, 4 mg/2 mg OD) or 3 (rosi/glim, 4 mg/4 mg OD). In any participant with hypoglycemia events at Wks 4, 8, 12, or any unscheduled visits, the dose level was reduced by one (level 3 to 2, or level 2 to 1).
786295|NCT01453036|B4|Baseline|Total|Total of all reporting groups
786296|NCT01453036|B3|Baseline|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
786297|NCT01453036|B2|Baseline|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
786298|NCT01453036|B1|Baseline|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
786299|NCT01453036|P3|Participant Flow|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
786300|NCT01453036|P2|Participant Flow|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
786301|NCT01453036|P1|Participant Flow|Conventional AOC Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
786302|NCT01453036|O3|Outcome|Convential AOM Group|The investigators do not perform mutation test in the conventional group apply amoxicillin 1 g, bid , rabeprazole 20 mg bid, metronidazole 500mg tid during 1weeks
786303|NCT01453036|O2|Outcome|Mutation Test Group|Mutation test group is composed of two groups, clarithromycin group and metronidazole group Clarithromycin subgroup ; no point mutation at 23S rRNA apply clarithromycin 500 mg bid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week Metronidazole subgroup ; point mutation at 23S rRNA apply metronidazole 500 mg tid, amoxicillin 1 g bid, rabeprazole 20 mg bid during 1 week
786304|NCT01453036|O1|Outcome|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
786305|NCT01453036|E3|Reported Event|Mutation Test Group|
786306|NCT01453036|E2|Reported Event|Convential AOM Group|
786307|NCT01453036|E1|Reported Event|Convential AOC Group|amoxicillin 1 g, bid , rabeprazole 20 mg bid, clarithromycin 500 mg bid during 1weeks
786308|NCT01453023|B1|Baseline|FF 100 µg/VI 25 µg and FF 100 µg in TPs 1 and 2|All participants who received FF 100 µg/VI 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2 or FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
786309|NCT01453023|P2|Participant Flow|FF 100 µg in TP 1 and FF 100 µg/VI 25 µg in TP 2|Participants received FF 100 µg in Treatment Period 1 and FF 100 µg/VI 25 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
786310|NCT01453023|P1|Participant Flow|FF 100 µg/VI 25 µg in TP 1 and FF 100 µg in TP 2|Participants received fluticasone furoate (FF) 100 micrograms (µg)/Vilanterol (VI) 25 µg in Treatment Period 1 and FF 100 µg in Treatment Period 2. The first 14-day treatment period was followed by a washout period of at least 7 days. Inhaled FF 100 µg/VI 25 µg and FF 100 µg were administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler.
786311|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786312|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786313|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786870|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
786314|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786315|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786316|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786317|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786318|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786319|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786320|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786321|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786322|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786323|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786324|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786325|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786326|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786327|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786328|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786329|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786330|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786331|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786332|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786333|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786334|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786335|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786336|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786337|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
831349|NCT01289028|O1|Outcome|Nilotinib|ITT
786338|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786339|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786340|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786341|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786342|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786343|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786344|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786345|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786346|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786347|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786348|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786349|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786350|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786351|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786352|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786353|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786354|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786355|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786356|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786357|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786358|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786359|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786360|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786361|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
831350|NCT01289028|O1|Outcome|Nilotinib|
786362|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786363|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786364|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786365|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786366|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786367|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786368|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786369|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786370|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786371|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786372|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786373|NCT01453023|O2|Outcome|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786374|NCT01453023|O1|Outcome|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786375|NCT01453023|E2|Reported Event|FF 100 µg|Participants received FF 100 µg in one of the two 14-day treatment periods. FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786376|NCT01453023|E1|Reported Event|FF 100 µg/VI 25 µg|Participants received FF 100 µg/VI 25 µg in one of the two 14-day treatment periods. FF 100 µg/VI 25 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
786377|NCT01452854|B1|Baseline|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
786378|NCT01452854|P1|Participant Flow|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
786379|NCT01452854|O1|Outcome|Cancer|The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).
786380|NCT01452854|E1|Reported Event|Cancer|"The study cohort will include adult women of childbearing potential with a diagnosis of low grade glioma (WHO grade II) who are being treated with low doses of Temozolomide (Temodar).~Low recruitment necessitated the closing of the study. No results available."
786381|NCT01452425|B1|Baseline|Tourniquet|No adverse event
786382|NCT01452425|P1|Participant Flow|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
786383|NCT01452425|O1|Outcome|Tourniquet|
786384|NCT01452425|O1|Outcome|Tourniquet|"Inflation of a tourniquet~Tourniquet: Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion"
786385|NCT01452425|E1|Reported Event|Tourniquet|No adverse event
786386|NCT01452347|B3|Baseline|Total|Total of all reporting groups
786387|NCT01452347|B2|Baseline|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
786388|NCT01452347|B1|Baseline|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
786389|NCT01452347|P2|Participant Flow|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
786390|NCT01452347|P1|Participant Flow|Dabigatran Etexilate (DE)|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
786871|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786399|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
786400|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the PKS who have a corresponding predicted value.
786401|NCT01452347|O2|Outcome|Predicted|This includes the predicted Ctrough,ss value for all patients in the PKS who have a corresponding observed value.
786402|NCT01452347|O1|Outcome|Observed|This includes the observed Ctrough,ss value for all patients in the pharmacokinetic set (PKS) who have a corresponding predicted value.
786403|NCT01452347|E2|Reported Event|Warfarin|Oral administration of Warfarin 1mg, 3mg and 5 mg according to target international normalised ratio (INR), as recommended in guidelines, and deemed appropriate by investigator
786404|NCT01452347|E1|Reported Event|Dabigatran Etexilate|Oral administration of 1 capsule of 150 mg (150 mg), 2 capsules of 110 mg (220 mg), or 2 capsules of 150 mg (300 mg) twice daily
786405|NCT01452269|B3|Baseline|Total|Total of all reporting groups
786406|NCT01452269|B2|Baseline|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786407|NCT01452269|B1|Baseline|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786408|NCT01452269|P2|Participant Flow|Delayed Intervention Group|"This arm received the Group intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786409|NCT01452269|P1|Participant Flow|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786410|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786411|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786575|NCT01451632|P3|Participant Flow|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
831351|NCT01289028|O1|Outcome|Nilotinib|
786576|NCT01451632|P2|Participant Flow|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786412|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786413|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786414|NCT01452269|O2|Outcome|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786415|NCT01452269|O1|Outcome|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786416|NCT01452269|E2|Reported Event|Delayed Intervention Group|"This arm received the intervention one year following the immediate intervention group.Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786417|NCT01452269|E1|Reported Event|Immediate Intervention Group|"This arm received the Group intervention immediately following baseline data collection. Groups consisted of 4-12 subjects who meet for 2 hours a week for 16 weeks. Group sessions were offered at a variety of times. A trained, deaf, ASL-fluent counselor led the sessions.~Subjects completed a food and physical activity diary. Each intervention session included a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Subjects received a Personal Feedback Report periodically. Subjects earned points for complying with various aspects of the program. Points were redeemed for small prizes (i.e. water bottles).~The maintenance phase consisted of two meetings at the beginning of the 6-month maintenance period and three months later, and consisted of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
786418|NCT01452152|B4|Baseline|Total|Total of all reporting groups
786419|NCT01452152|B3|Baseline|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
786420|NCT01452152|B2|Baseline|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
786421|NCT01452152|B1|Baseline|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
786422|NCT01452152|P3|Participant Flow|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
786423|NCT01452152|P2|Participant Flow|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
786424|NCT01452152|P1|Participant Flow|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
786425|NCT01452152|O3|Outcome|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
786426|NCT01452152|O2|Outcome|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
786427|NCT01452152|O1|Outcome|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
786428|NCT01452152|E3|Reported Event|Standard of Care|Participants randomized to the SOC group will not have CYP2C19 genotype analysis performed. They will receive dual anti-platelet therapy guided by the judgment of their treating physician according to standard medical practice irrespective of genotype.
786429|NCT01452152|E2|Reported Event|Genotype-directed, Prasugrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 intermediate and poor metabolizers will receive prasugrel.~prasugrel: Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year"
786430|NCT01452152|E1|Reported Event|Genotype-directed, Clopidogrel|"Participants randomized to the G-D group will have CYP2C19 genotype analysis performed. CYP2C19 extensive and ultrarapid metabolizers will receive clopidogrel.~clopidogrel: clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year"
786431|NCT01452126|B1|Baseline|Ropivacaine|Each patient received ropivacaine-based nerve blockade at a fixed volume, with concentration determined per protocol
786432|NCT01452126|P1|Participant Flow|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
786433|NCT01452126|O1|Outcome|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
786434|NCT01452126|O4|Outcome|Popliteal Nerve Block|Ropivacaine-based blockade of the popliteal nerve, with concentration per protocol.
786435|NCT01452126|O3|Outcome|Infraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via an infraclavicular approach, with concentration per protocol.
786436|NCT01452126|O2|Outcome|Supraclavicular Blockade|Ropivacaine-based blockade of the brachial plexus nerves via a supraclavicular approach, with concentration per protocol.
786437|NCT01452126|O1|Outcome|Femoral Nerve Block|Ropivacaine-based blockade of the femoral nerve, with concentration per protocol.
786438|NCT01452126|E1|Reported Event|Ropivacaine|"Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient~Ropivacaine concentration: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block"
786439|NCT01451983|B5|Baseline|Total|Total of all reporting groups
786440|NCT01451983|B4|Baseline|Siblings|Siblings of individuals with autism spectrum disorders.
786441|NCT01451983|B3|Baseline|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
786442|NCT01451983|B2|Baseline|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
786443|NCT01451983|B1|Baseline|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
786444|NCT01451983|P4|Participant Flow|Siblings|Siblings of individuals with autism spectrum disorders.
786445|NCT01451983|P3|Participant Flow|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
786446|NCT01451983|P2|Participant Flow|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
786447|NCT01451983|P1|Participant Flow|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
786448|NCT01451983|O4|Outcome|Siblings|Siblings of individuals with autism spectrum disorders.
786449|NCT01451983|O3|Outcome|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
786450|NCT01451983|O2|Outcome|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
786451|NCT01451983|O1|Outcome|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
786452|NCT01451983|E4|Reported Event|Siblings|Siblings of individuals with autism spectrum disorders.
786453|NCT01451983|E3|Reported Event|ASD no PTEN no Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation without a large head circumference.
786454|NCT01451983|E2|Reported Event|ASD no PTEN Macrocephaly|Individuals with autism spectrum disorder who do not have a PTEN mutation with a large head circumference.
786455|NCT01451983|E1|Reported Event|ASD With PTEN|Individuals with autism spectrum disorder who are also found to have a PTEN mutation.
786456|NCT01451931|B4|Baseline|Total|Total of all reporting groups
786457|NCT01451931|B3|Baseline|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786861|NCT01451411|B3|Baseline|Total|Total of all reporting groups
786458|NCT01451931|B2|Baseline|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786459|NCT01451931|B1|Baseline|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786460|NCT01451931|P3|Participant Flow|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786461|NCT01451931|P2|Participant Flow|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786462|NCT01451931|P1|Participant Flow|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786463|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786464|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786465|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786466|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786467|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786468|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786469|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786470|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786471|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786472|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786473|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786474|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786475|NCT01451931|O3|Outcome|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786476|NCT01451931|O2|Outcome|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786477|NCT01451931|O1|Outcome|Point-of-care Ultrasound|"Patient with suspected urolithiasis will receive ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786478|NCT01451931|E3|Reported Event|Computed Tomography|"Patient with suspected urolithiasis received computed tomography in the radiology department.~CT in Radiology: Computed tomography of abdomen completed in the radiology department at time 0."
786479|NCT01451931|E2|Reported Event|Radiology Ultrasound|"Patient with suspected urolithiasis received diagnostic ultrasonography in the radiology department.~Diagnostic ultrasonography in radiology department: Diagnostic ultrasound completed in the radiology department at time 0."
786480|NCT01451931|E1|Reported Event|Point-of-care Ultrasound|"Patient with suspected urolithiasis received ultrasonography performed in the emergency department.~Ultrasonography in the Emergency Department: Perform ultrasonography in the ED (physician)."
786481|NCT01451814|B3|Baseline|Total|Total of all reporting groups
786482|NCT01451814|B2|Baseline|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786483|NCT01451814|B1|Baseline|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
831352|NCT01289028|O1|Outcome|Nilotinib|
786484|NCT01451814|P2|Participant Flow|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786485|NCT01451814|P1|Participant Flow|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786486|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786487|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786488|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786489|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786490|NCT01451814|O2|Outcome|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786491|NCT01451814|O1|Outcome|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786492|NCT01451814|E2|Reported Event|Standard Treatment|"6 sessions of individual behavioral smoking cessation counseling with 8 weeks of transdermal nicotine patch. Inlcudes relaxation training to match time in the experimental condition~Nicotine polacrilex: 8 weeks of nicotine patch~Relaxation training: Instructions in progressive muscle relaxation~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786493|NCT01451814|E1|Reported Event|Positive Psychotherapy|"6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Positive Psychotherapy for smoking cessation: 6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.~Nicotine polacrilex: 8 weeks of nicotine patch~Behavioral smoking cessation treatment: Counseling on techniques to manage triggers and avoid smoking"
786494|NCT01451775|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 3 period crossover trial. 18 patients were randomised to one of six treatment sequences and treated. The trial was open label with washout periods of at least 7 days between treatments.
786495|NCT01451775|P6|Participant Flow|Empa 10mg Fasted / Empa 25mg Fed / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
786496|NCT01451775|P5|Participant Flow|Empa 10mg Fasted / Empa 25mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
786536|NCT01451749|O1|Outcome|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
786497|NCT01451775|P4|Participant Flow|Empa 25mg Fed / Empa 10mg Fasted / Empa 25mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours."
786498|NCT01451775|P3|Participant Flow|Empa 25mg Fed / Empa 25mg Fasted / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
786499|NCT01451775|P2|Participant Flow|Empa 25mg Fasted / Empa 10mg Fasted / Empa 25mg Fed|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 10 mg empa after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast"
786500|NCT01451775|P1|Participant Flow|Empa 25mg Fasted / Empa 25mg Fed / Empa 10mg Fasted|"Patients were administered three treatments in the following order:~A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.~A single dose of 25 mg empa after a standardised high-fat, high-caloric breakfast~A single dose of 10 mg empa after an overnight fast of at least 10 hours."
786501|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786502|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
786503|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786504|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786505|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
786506|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786507|NCT01451775|O3|Outcome|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786508|NCT01451775|O2|Outcome|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
786509|NCT01451775|O1|Outcome|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786510|NCT01451775|E3|Reported Event|Empa 10 mg Fasted|A single dose of 10 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786511|NCT01451775|E2|Reported Event|Empa 25 mg Fed|A single dose of 25 mg empagliflozin (empa) after a standardised high-fat, high-caloric breakfast.
786512|NCT01451775|E1|Reported Event|Empa 25 mg Fasted|A single dose of 25 mg empagliflozin (empa) after an overnight fast of at least 10 hours.
786513|NCT01451762|B4|Baseline|Total|Total of all reporting groups
786514|NCT01451762|B3|Baseline|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
786515|NCT01451762|B2|Baseline|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
786516|NCT01451762|B1|Baseline|Placebo|.9 normal saline IV
786517|NCT01451762|P3|Participant Flow|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
786518|NCT01451762|P2|Participant Flow|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
786519|NCT01451762|P1|Participant Flow|Placebo|.9 normal saline IV
786520|NCT01451762|O3|Outcome|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
786521|NCT01451762|O2|Outcome|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
786522|NCT01451762|O1|Outcome|Placebo|.9 normal saline IV
786523|NCT01451762|E3|Reported Event|50 mg Diphenhydramine IV|50 mg diphenhydramine IV administered before surgery
786524|NCT01451762|E2|Reported Event|25 mg Diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
786525|NCT01451762|E1|Reported Event|Placebo|.9 normal saline IV
786526|NCT01451749|B3|Baseline|Total|Total of all reporting groups
786527|NCT01451749|B2|Baseline|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
786528|NCT01451749|B1|Baseline|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
786529|NCT01451749|P2|Participant Flow|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
786530|NCT01451749|P1|Participant Flow|Shenwu Capsule|Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months
786531|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
786532|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
786533|NCT01451749|O2|Outcome|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
786534|NCT01451749|O1|Outcome|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
786535|NCT01451749|O2|Outcome|Donepezil|"Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
786537|NCT01451749|E2|Reported Event|Donepezil|"1 tablet contains 5 mg of donepezil, 1 tablet/time, 1time/day for 6 months.~Donepezil: This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.~Placebo identical to shenwu capsules: 5 capsules/time,3times/day for 6months."
786538|NCT01451749|E1|Reported Event|Shenwu Capsule|"1 capsule contains 451 mg of Shenwu extracts. 5 capsules/time, 3 times/day for 6 months.~Shenwu Capsule: 1 shenwu capsule contains 451 mg extract from herbs. 5 capsules/time, 3 times/day for 6 months. Placebo identical to donepezil: 1 placebo tablet/time,1 time/day for 6 months"
786539|NCT01451723|B3|Baseline|Total|Total of all reporting groups
786540|NCT01451723|B2|Baseline|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
786541|NCT01451723|B1|Baseline|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
786542|NCT01451723|P2|Participant Flow|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
786543|NCT01451723|P1|Participant Flow|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
786544|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
786545|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
786546|NCT01451723|O2|Outcome|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
786547|NCT01451723|O1|Outcome|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
786548|NCT01451723|E2|Reported Event|Placebo|"Matching placebo capsules.~Placebo: Matching placebo capsules"
786549|NCT01451723|E1|Reported Event|Polyphenon E 400mg Twice a Day|"Two capsules of Polyphenon E containing 200mg of EGCG each taken twice a day with food.~Polyphenon E: Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food."
786550|NCT01451645|B3|Baseline|Total|Total of all reporting groups
786551|NCT01451645|B2|Baseline|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
786552|NCT01451645|B1|Baseline|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
786553|NCT01451645|P2|Participant Flow|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
786554|NCT01451645|P1|Participant Flow|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
786555|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
786556|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
786557|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
786558|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
786559|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
786560|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
786561|NCT01451645|O2|Outcome|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
786562|NCT01451645|O1|Outcome|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
786563|NCT01451645|E2|Reported Event|Colchicine (Colcrys®) 0.6mg|daily 0.6 mg colchicine dosing for 16 weeks with background allopurinol therapy
786564|NCT01451645|E1|Reported Event|Placebo|daily placebo dosing for 16 weeks with background allopurinol therapy
786565|NCT01451632|B3|Baseline|Total|Total of all reporting groups
786566|NCT01451632|B2|Baseline|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786567|NCT01451632|B1|Baseline|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786568|NCT01451632|P10|Participant Flow|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786569|NCT01451632|P9|Participant Flow|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786570|NCT01451632|P8|Participant Flow|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786571|NCT01451632|P7|Participant Flow|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786572|NCT01451632|P6|Participant Flow|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
786573|NCT01451632|P5|Participant Flow|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786574|NCT01451632|P4|Participant Flow|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786577|NCT01451632|P1|Participant Flow|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
786578|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786579|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786580|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786581|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786582|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
786583|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786584|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786585|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786586|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786587|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
786588|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
786589|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
786590|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
786591|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
786592|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
786593|NCT01451632|O5|Outcome|Part 2: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses plus cetuximab 400/250 mg/m2 plus irinotecan 180 mg/m2
786594|NCT01451632|O4|Outcome|Part 2: 20 mg/kg|MM-121: 20 mg/kg plus cetuximab at 400/250 mg/m2 plus irinotecan at 180 mg/m2
786595|NCT01451632|O3|Outcome|Part 1: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance doses Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
786596|NCT01451632|O2|Outcome|Part 1: 20 mg/kg|MM-121: 20 mg/kg Plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
786597|NCT01451632|O1|Outcome|Part 1: 12 mg/kg|MM-121 mg/kg plus cetuximab at either 400/200 mg/m2 or 400/250 mg/m2
786598|NCT01451632|O10|Outcome|Part 2: Expansion Cohort|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786599|NCT01451632|O9|Outcome|Part 2: Cohort 2|"MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786600|NCT01451632|O8|Outcome|Part 2: Cohort 1|"MM-121: 20 mg/kg IV QW~Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW~Irinotecan: 180 mg/m2 IV Q2W"
786601|NCT01451632|O7|Outcome|Part 1: Expansion Cohort|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786602|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg one time loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 one-time loading dose followed by 250 mg/m2 maintenance IV QW
786603|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786604|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786605|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786606|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786607|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV weekly in 4-week cycles Cetuximab: 400 mg/m2 IV one-time loading dose followed by 200 mg/m2 IV weekly maintenance doses
786608|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786609|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786610|NCT01451632|O2|Outcome|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786611|NCT01451632|O1|Outcome|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786612|NCT01451632|O8|Outcome|Part 2: Cohort 2|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
786613|NCT01451632|O7|Outcome|Part 2: Cohort 1|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW Irinotecan: 180 mg/m2 IV Q2W
786873|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786614|NCT01451632|O6|Outcome|Part 1: Cohort 4|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786615|NCT01451632|O5|Outcome|Part 1: Cohort 3b|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786616|NCT01451632|O4|Outcome|Part 1: Cohort 3a|MM-121: 40 mg/kg loading dose followed by 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786617|NCT01451632|O3|Outcome|Part 1: Cohort 2b|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 250 mg/m2 maintenance IV QW
786618|NCT01451632|O2|Outcome|Part 1: Cohort 2a|MM-121: 20 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786619|NCT01451632|O1|Outcome|Part 1: Cohort 1|MM-121: 12 mg/kg IV QW Cetuximab: 400 mg/m2 loading dose followed by 200 mg/m2 maintenance IV QW
786620|NCT01451632|E2|Reported Event|Part 2: MM-121 + Cetuximab + Irinotecan|"increasing doses of irinotecan + the RP2D of MM121 + cetuximab as determined in Part 1~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Irinotecan: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786621|NCT01451632|E1|Reported Event|Part 1: MM-121 + Cetuximab|"increasing doses of weekly MM-121 + weekly cetuximab~MM-121 (SAR256212): MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)~Cetuximab: MM-121 (SAR256212) (IV) plus Cetuximab (IV) and Irinotecan (IV)"
786622|NCT01451554|B3|Baseline|Total|Total of all reporting groups
786623|NCT01451554|B2|Baseline|Usual Care|Provided with self-help booklets on diet and exercise.
786624|NCT01451554|B1|Baseline|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
786625|NCT01451554|P2|Participant Flow|Usual Care|Provided with self-help booklets on diet and exercise.
786626|NCT01451554|P1|Participant Flow|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
786627|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
786628|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
786629|NCT01451554|O2|Outcome|Usual Care|Provided with self-help booklets on diet and exercise.
786630|NCT01451554|O1|Outcome|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
786631|NCT01451554|E2|Reported Event|Usual Care|Provided with self-help booklets on diet and exercise.
786632|NCT01451554|E1|Reported Event|Portion Control Intervention|Individuals will be given a portion control plate and dietary counseling
786633|NCT01451541|B4|Baseline|Total|Total of all reporting groups
786634|NCT01451541|B3|Baseline|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786635|NCT01451541|B2|Baseline|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786636|NCT01451541|B1|Baseline|Placebo|Placebo: placebo - one dose per nostril
786637|NCT01451541|P3|Participant Flow|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786638|NCT01451541|P2|Participant Flow|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786639|NCT01451541|P1|Participant Flow|Placebo|Placebo: placebo - one dose per nostril
786640|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786641|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786642|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786643|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786644|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786645|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786646|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786647|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786648|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786649|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786650|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786651|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786652|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786653|NCT01451541|O1|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786654|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786655|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786656|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786657|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786862|NCT01451411|B2|Baseline|Placebo|Placebo: Intravenous
786658|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786659|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786660|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786661|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786662|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786663|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786664|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786665|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786666|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786667|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786668|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786669|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786670|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786671|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786672|NCT01451541|O3|Outcome|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786673|NCT01451541|O2|Outcome|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786674|NCT01451541|O1|Outcome|Placebo|Placebo: placebo - one dose per nostril
786675|NCT01451541|E3|Reported Event|Ciclesonide Nasal Aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg once daily
786676|NCT01451541|E2|Reported Event|Ciclesonide Nasal Aerosol 37mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37mcg once daily
786677|NCT01451541|E1|Reported Event|Placebo|Placebo: placebo - one dose per nostril
786678|NCT01451437|B10|Baseline|Total|Total of all reporting groups
786679|NCT01451437|B9|Baseline|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786680|NCT01451437|B8|Baseline|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786681|NCT01451437|B7|Baseline|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786682|NCT01451437|B6|Baseline|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786683|NCT01451437|B5|Baseline|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786684|NCT01451437|B4|Baseline|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786685|NCT01451437|B3|Baseline|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786686|NCT01451437|B2|Baseline|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786687|NCT01451437|B1|Baseline|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786688|NCT01451437|P9|Participant Flow|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786689|NCT01451437|P8|Participant Flow|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786690|NCT01451437|P7|Participant Flow|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786691|NCT01451437|P6|Participant Flow|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786692|NCT01451437|P5|Participant Flow|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786693|NCT01451437|P4|Participant Flow|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786694|NCT01451437|P3|Participant Flow|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786695|NCT01451437|P2|Participant Flow|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786696|NCT01451437|P1|Participant Flow|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786697|NCT01451437|O9|Outcome|Pt 2 Arm A: MK-8242 300 mg BID|Participants to receive MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg to be administered QD in the morning) in Part 2 Arm A.
786698|NCT01451437|O8|Outcome|Pt 2 Arm A: MK-8242 250 mg BID|Participants to receive MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg to be administered QD in the morning) in Part 2 Arm A.
786699|NCT01451437|O7|Outcome|Pt 2 Arm A: MK-8242 210 mg BID|Participants to receive MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg to be administered QD in the morning) in Part 2 Arm A.
786700|NCT01451437|O6|Outcome|Pt 2 Arm A: MK-8242 170 mg BID|Participants to receive MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg to be administered QD in the morning) in Part 2 Arm A.
786701|NCT01451437|O5|Outcome|Pt 2 Arm A: MK-8242 120 mg BID|Participants to receive MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg to be administered QD in the morning) in Part 2 Arm A.
786702|NCT01451437|O4|Outcome|Pt 2 Arm A: MK-8242 250 mg QD|Participants to receive MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
786703|NCT01451437|O3|Outcome|Pt 2 Arm A: MK-8242 120 mg QD|Participants to receive MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
786704|NCT01451437|O2|Outcome|Pt 2 Arm A: MK-8242 60 mg QD|Participants to receive MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
786705|NCT01451437|O1|Outcome|Pt 2 Arm A: MK-8242 30 mg QD|Participants to receive MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 2 Arm A.
786706|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786707|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786708|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786709|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786710|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786711|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786712|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786713|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786714|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786715|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786716|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786717|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786718|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786719|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786720|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786721|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786722|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786723|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786724|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786725|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786726|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786727|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786728|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786729|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786730|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786731|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786732|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786733|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786734|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786735|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786736|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786737|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786738|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786739|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786740|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786741|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786742|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786743|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786744|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786745|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786746|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786747|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786748|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786749|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786750|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786751|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786752|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786753|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786754|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786755|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786756|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786757|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786758|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786759|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786760|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786761|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786762|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786763|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786764|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786765|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786766|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786767|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786768|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786769|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786770|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786771|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786772|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786773|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786774|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786775|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786776|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786777|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786778|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786779|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786780|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786781|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786782|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786783|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786784|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786785|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786786|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786787|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786788|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786789|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786790|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786791|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786792|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786793|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786794|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786795|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786796|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786797|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786798|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786799|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786800|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786801|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786802|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786803|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786804|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786805|NCT01451437|O9|Outcome|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786806|NCT01451437|O8|Outcome|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786807|NCT01451437|O7|Outcome|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786808|NCT01451437|O6|Outcome|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786809|NCT01451437|O5|Outcome|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786810|NCT01451437|O4|Outcome|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786811|NCT01451437|O3|Outcome|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786812|NCT01451437|O2|Outcome|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786813|NCT01451437|O1|Outcome|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786814|NCT01451437|E9|Reported Event|Pt 1 Arm A: MK-8242 300 mg BID|Participants received MK-8242 300 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 300 mg was administered QD in the morning) in Part 1 Arm A.
786815|NCT01451437|E8|Reported Event|Pt 1 Arm A: MK-8242 250 mg BID|Participants received MK-8242 250 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 250 mg was administered QD in the morning) in Part 1 Arm A.
786816|NCT01451437|E7|Reported Event|Pt 1 Arm A: MK-8242 210 mg BID|Participants received MK-8242 210 mg BID monotherapy on Days 1-7 of each 21-day cycle (except Cycle 1 Day 7 on which MK-8242 210 mg was administered QD in the morning) in Part 1 Arm A.
786817|NCT01451437|E6|Reported Event|Pt 1 Arm A: MK-8242 170 mg BID|Participants received MK-8242 170 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 170 mg was administered QD in the morning) in Part 1 Arm A.
786818|NCT01451437|E5|Reported Event|Pt 1 Arm A: MK-8242 120 mg BID|Participants received MK-8242 120 mg BID monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7 on which MK-8242 120 mg was administered QD in the morning) in Part 1 Arm A.
786819|NCT01451437|E4|Reported Event|Pt 1 Arm A: MK-8242 250 mg QD|Participants received MK-8242 250 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786820|NCT01451437|E3|Reported Event|Pt 1 Arm A: MK-8242 120 mg QD|Participants received MK-8242 120 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786821|NCT01451437|E2|Reported Event|Pt 1 Arm A: MK-8242 60 mg QD|Participants received MK-8242 60 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786822|NCT01451437|E1|Reported Event|Pt 1 Arm A: MK-8242 30 mg QD|Participants received MK-8242 30 mg QD monotherapy on Days 1-7 and Days 15-21 of each 28-day cycle in Part 1 Arm A.
786823|NCT01451424|B5|Baseline|Total|Total of all reporting groups
786824|NCT01451424|B4|Baseline|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
786825|NCT01451424|B3|Baseline|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 weeks Includes subjects from both arms 1 and 3 (PK group and non-PK groups)"
786826|NCT01451424|B2|Baseline|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786827|NCT01451424|B1|Baseline|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786828|NCT01451424|P4|Participant Flow|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks~All subjects completed the placebo run-in period and started active dosing."
786829|NCT01451424|P3|Participant Flow|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1, PK group) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks~The first 6 subjects (arm 1) had no placebo run-in period. Arm 3 subjects all completed the placebo run-in period and started active dosing."
786830|NCT01451424|P2|Participant Flow|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
786831|NCT01451424|P1|Participant Flow|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks~All subjects completed the placebo run-in period and started active dosing."
786832|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
786833|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
786834|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786835|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786836|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
786837|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
786838|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786839|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786840|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
786841|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
786842|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786843|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786844|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
786845|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
786846|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786847|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786848|NCT01451424|O5|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
786849|NCT01451424|O4|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
786850|NCT01451424|O3|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786851|NCT01451424|O2|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786852|NCT01451424|O1|Outcome|Proellex 12 mg PK Group|"Subjects receiving 12 mg Proellex administered vaginally, and completing a PK arm consisting of 1 x 24 hr PK of Proellex, 14 days of daily Proellex trough measurements, and 1 x 24 hr PK of Proellex after 14 days of daily dosing. 12 mg PK subjects will continue with the protocol as written after the first 2 week period.~Proellex: vaginal suppository, daily, for 12 weeks"
786853|NCT01451424|O4|Outcome|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 16 weeks"
786854|NCT01451424|O3|Outcome|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 or 16 weeks~Proellex: vaginal suppository, daily, for 12 or 16 weeks~The first 6 subjects dosed at 12 mg (arm 1) were dosed for 16 weeks, the second 6 (arm 3) were dosed for 12 weeks"
786855|NCT01451424|O2|Outcome|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786856|NCT01451424|O1|Outcome|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786857|NCT01451424|E4|Reported Event|24 mg Proellex|"24 mg vaginal Proellex daily~Proellex: vaginal suppository, daily, for 12 weeks"
786858|NCT01451424|E3|Reported Event|Proellex 12 mg Per Protocol|"Subjects receiving 12 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786859|NCT01451424|E2|Reported Event|Proellex 6 mg Per Protocol|"Subjects receiving 6 mg Proellex daily, vaginally for 12 weeks~Proellex: vaginal suppository, daily, for 12 weeks"
786860|NCT01451424|E1|Reported Event|Proellex 3 mg Per Protocol|"Subjects will receive 3 mg Proellex daily, vaginally for 12 weeks.~Proellex: vaginal suppository, daily, for 12 weeks"
786877|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786878|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
786879|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786880|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
786881|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786882|NCT01451411|O2|Outcome|Placebo|Placebo: Intravenous
786883|NCT01451411|O1|Outcome|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786884|NCT01451411|E2|Reported Event|Placebo|Placebo: Intravenous
786885|NCT01451411|E1|Reported Event|Conivaptan Hydrochloride|Conivaptan hydrochloride: Intravenous
786886|NCT01451398|B3|Baseline|Total|Total of all reporting groups
786887|NCT01451398|B2|Baseline|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786888|NCT01451398|B1|Baseline|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786889|NCT01451398|P2|Participant Flow|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786890|NCT01451398|P1|Participant Flow|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786891|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786892|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786893|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786894|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786895|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786896|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786897|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786898|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786899|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786900|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786901|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786902|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786903|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786904|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786905|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786906|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786907|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786908|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786909|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786910|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786911|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786912|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
831353|NCT01289028|E1|Reported Event|All Patients|All patients
786913|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
788436|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
786914|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786915|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786916|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786917|NCT01451398|O2|Outcome|Technosphere Powder|Technosphere powder (with no insulin) administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786918|NCT01451398|O1|Outcome|TI Inhalation Powder + OADs|Technosphere Insulin powder administered via the Gen2 inhaler added to 2 or more stable Oral Antidiabetic Drugs (OADs), doses individualized for each patient
786919|NCT01451398|E2|Reported Event|Technosphere Powder|"technosphere powder (with no insulin) administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere Powder: Placebo Comparator"
786920|NCT01451398|E1|Reported Event|TI Inhalation Powder|"Technosphere® Insulin powder administered via the Gen2 inhaler added to 1 - 3 stable OADs~Technosphere® Insulin: Technosphere® Insulin Inhalation Powder"
786921|NCT01451203|B3|Baseline|Total|Total of all reporting groups
786922|NCT01451203|B2|Baseline|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786923|NCT01451203|B1|Baseline|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786924|NCT01451203|P2|Participant Flow|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786925|NCT01451203|P1|Participant Flow|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786926|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786927|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786928|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786929|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786930|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786931|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786932|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786933|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786934|NCT01451203|O2|Outcome|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786935|NCT01451203|O1|Outcome|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786936|NCT01451203|E2|Reported Event|CZP + MTX|Participants who received certolizumab pegol (CZP) subcutaneously at a loading dose of CZP 400 mg every 2 weeks (Q2W) at Weeks 0, 2, and 4; followed by a dose of CZP 200 mg subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786937|NCT01451203|E1|Reported Event|PBO + MTX|Participants who received placebo subcutaneously every two weeks (Q2W) at Weeks 0, 2, and 4; followed by placebo subcutaneously Q2W from Week 6 to Week 50 and an oral dose of MTX administered from Week 0 onwards
786938|NCT01450813|B5|Baseline|Total|Total of all reporting groups
786939|NCT01450813|B4|Baseline|Group 4|Rocuronium dose 0.6 mg/kg prior to laryngoscopy
786940|NCT01450813|B3|Baseline|Group 3|Rocuronium dose 0.4 mg/kg prior to laryngoscopy
786941|NCT01450813|B2|Baseline|Group 2|Rocuronium dose 0.2 mg/kg prior to laryngoscopy
786942|NCT01450813|B1|Baseline|Group 1|Rocuronium dose 0 mg/kg prior to laryngoscopy
786943|NCT01450813|P4|Participant Flow|Group 4|Rocuronium 0.6 mg/kg
786944|NCT01450813|P3|Participant Flow|Group 3|Rocuronium 0.4 mg/kg
786945|NCT01450813|P2|Participant Flow|Group 2|Rocuronium 0.2 mg/kg
786946|NCT01450813|P1|Participant Flow|Group 1|Saline 0.06 ml/kg
786947|NCT01450813|O2|Outcome|Remifentanil 8 ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
829125|NCT01297062|E2|Reported Event|Placebo|Placebo Comparator
786948|NCT01450813|O1|Outcome|Remifentanil 2ng/ml|The anesthesia provider will titrate propofol as appropriate throughout the procedure to maintain a BIS level between 45- 60.
786949|NCT01450813|O4|Outcome|Group 4|Rocuronium 0.6mg/kg
786950|NCT01450813|O3|Outcome|Group 3|Rocuronium 0.4mg/kg
786951|NCT01450813|O2|Outcome|Group 2|Rocuronium 0.2mg/kg
786952|NCT01450813|O1|Outcome|Group 1|Rocuronium 0mg/kg
786953|NCT01450813|E4|Reported Event|Group 4|Rocuronium dose 0.6 mg/kg
786954|NCT01450813|E3|Reported Event|Group 3|Rocuronium dose 0.4 mg/kg
786955|NCT01450813|E2|Reported Event|Group 2|Rocuronium dose 0.2 mg/kg
786956|NCT01450813|E1|Reported Event|Group 1|Rocuronium dose 0 mg/kg
786957|NCT01450800|B3|Baseline|Total|Total of all reporting groups
786958|NCT01450800|B2|Baseline|Placebo|Participants randomized to receive placebo instructed to take placebo 1 tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
786959|NCT01450800|B1|Baseline|Nitrofurantoin|Participants randomized to receive antibiotics instructed to take nitrofurantoin 100mg by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
786960|NCT01450800|P2|Participant Flow|Placebo|Randomized to placebo 1 tablet daily for each day of catheterization for up to 7 days
786961|NCT01450800|P1|Participant Flow|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily for each day of catheterization for up to 7 days
786962|NCT01450800|O1|Outcome|Urine Cultures Performed|All participants in the final analysis were examined
786963|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
786964|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
786965|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
786966|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
786967|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
786968|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
786969|NCT01450800|O1|Outcome|All Participants in Final Analysis|All participants in the final analysis were examined
786970|NCT01450800|O2|Outcome|Placebo|Randomized to placebo 1 tab daily while using a catheter for up to 7 days
786971|NCT01450800|O1|Outcome|Nitrofurantoin|Randomized to nitrofurantoin 100mg daily while using a catheter for up to 7 days
786972|NCT01450800|E2|Reported Event|Placebo|Participants randomized to receive placebo 1 tablet by mouth daily each day of catheterization for up to one week after surgery
786973|NCT01450800|E1|Reported Event|Nitrofurantoin|Participants randomized to receive nitrofurantoin 100mg by mouth daily each day of catheterization for up to one week after surgery
786974|NCT01450787|B3|Baseline|Total|Total of all reporting groups
786975|NCT01450787|B2|Baseline|Non Diabetics|non diabetics over age 40
786976|NCT01450787|B1|Baseline|Diabetics|diabetics over age 40
786977|NCT01450787|P2|Participant Flow|Non Diabetics|non diabetics over age 40
786978|NCT01450787|P1|Participant Flow|Diabetics|diabetics over age 40
786979|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
786980|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
786981|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
786982|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
786983|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
786984|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
786985|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
786986|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
786987|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
786988|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
786989|NCT01450787|O2|Outcome|Non Diabetics|non diabetics over age 40
786990|NCT01450787|O1|Outcome|Diabetics|diabetics over age 40
786991|NCT01450787|E2|Reported Event|Non Diabetics|non diabetics over age 40
786992|NCT01450787|E1|Reported Event|Diabetics|diabetics over age 40
786993|NCT01450761|B3|Baseline|Total|Total of all reporting groups
786994|NCT01450761|B2|Baseline|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
786995|NCT01450761|B1|Baseline|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
786996|NCT01450761|P2|Participant Flow|Placebo and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with placebo every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
786997|NCT01450761|P1|Participant Flow|Ipilimumab and Platinum/Etoposide|During the lead-in chemotherapy (induction) phase, participants received platinum/etoposide (investigator's choice of platinum) every 3 weeks for 4 cycles, with ipilimumab (10 mg/kg IV) every 3 weeks for cycles 3-6. During the treatment with blinded study therapy phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
787362|NCT01449708|O2|Outcome|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
787363|NCT01449708|O1|Outcome|Classic / Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
786998|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
786999|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
787000|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
787001|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
787002|NCT01450761|O2|Outcome|Placebo and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
787003|NCT01450761|O1|Outcome|Ipilimumab and Platinum/Etoposide|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
787004|NCT01450761|E2|Reported Event|PLACEBO + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with placebo every 3 weeks from cycle 3-6 during the Induction phase. During the maintenance phase, placebo was administered every 12 weeks, beginning 9-12 weeks after the last Induction dose, for a maximum treatment period of 3 years from the first dose of placebo.
787005|NCT01450761|E1|Reported Event|10 MG/KG IPILIMUMAB + PLATINUM/ETOPOSIDE|Participants received platinum/etoposide (investigator's choice of carboplatin or cisplatin) every 3 weeks for 4 cycles with ipilimumab (10 mg/kg IV) every 3 weeks from cycle 3-6 of Induction phase. During the maintenance phase, ipilimumab (10 mg/kg IV) was administered every 12 weeks, beginning 9-12 weeks after the last induction dose, for a maximum treatment period of 3 years from the first dose of ipilimumab.
787006|NCT01450696|B3|Baseline|Total|Total of all reporting groups
787007|NCT01450696|B2|Baseline|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787008|NCT01450696|B1|Baseline|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787009|NCT01450696|P2|Participant Flow|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787010|NCT01450696|P1|Participant Flow|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 followed by 6 mg/kg every three weeks (q3w) as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 milligrams per meter-squared (mg/m^2) intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787011|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787012|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787013|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787014|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787015|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787016|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787017|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787018|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787019|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787020|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787021|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787022|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787023|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787024|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787025|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787026|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787027|NCT01450696|O2|Outcome|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787056|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787028|NCT01450696|O1|Outcome|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787029|NCT01450696|E2|Reported Event|Capecitabine + Cisplatin + Herceptin (10 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 10 mg/kg q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787030|NCT01450696|E1|Reported Event|Capecitabine + Cisplatin + Herceptin (6 mg/kg)|Participants received Herceptin at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 mg/kg q3w as standard of care from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason (cycle length = 21 days). Participants also received cisplatin 80 mg/m^2 intravenously q3w plus capecitabine 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 treatment cycles (Cycles 1 to 6).
787031|NCT01450683|B1|Baseline|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
787032|NCT01450683|P1|Participant Flow|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
787033|NCT01450683|O1|Outcome|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
787034|NCT01450683|E1|Reported Event|Itraconazole|"Itraconazole: 600 mg/day oral (PO)~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
787035|NCT01450631|B3|Baseline|Total|Total of all reporting groups
787036|NCT01450631|B2|Baseline|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
787037|NCT01450631|B1|Baseline|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
787038|NCT01450631|P2|Participant Flow|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
787039|NCT01450631|P1|Participant Flow|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
787057|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787058|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787059|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787060|NCT01450319|E1|Reported Event|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787040|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
787041|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
787042|NCT01450631|O2|Outcome|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
787043|NCT01450631|O1|Outcome|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
787044|NCT01450631|E2|Reported Event|Prevena™ (PIMS)|"PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period.~Prevena™ Incision Management System (PIMS): PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister."
787045|NCT01450631|E1|Reported Event|Standard Dressing|"Standard-of-care includes coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™) consistent with the national standard for dressing Cesarean section incisions.~Standard-of-care Dressing: The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy."
787046|NCT01450397|B1|Baseline|XIAFLEX|Patient who have received XIAFLEX
787047|NCT01450397|P1|Participant Flow|XIAFLEX|0.58 mg of Xiaflex injected into a palpable Dupuytren's cord
787048|NCT01450397|O1|Outcome|XIAFLEX|Subjects receiving one Xiaflex injection
787049|NCT01450397|E1|Reported Event|XIAFLEX|Patient who received XIAFLEX
787050|NCT01450319|B1|Baseline|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787051|NCT01450319|P1|Participant Flow|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787052|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787053|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787054|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787055|NCT01450319|O1|Outcome|Cetuximab|Cetuximab was administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
787061|NCT01450306|B3|Baseline|Total|Total of all reporting groups
787062|NCT01450306|B2|Baseline|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
787063|NCT01450306|B1|Baseline|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
787064|NCT01450306|P2|Participant Flow|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
787065|NCT01450306|P1|Participant Flow|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
787066|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
787067|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
787068|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
787069|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
787070|NCT01450306|O2|Outcome|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
787071|NCT01450306|O1|Outcome|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
787072|NCT01450306|E2|Reported Event|Placebo Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus oral placebo capsule administered 1 hr prior to exposure therapy session
787073|NCT01450306|E1|Reported Event|D-cycloserine Plus Exposure Therapy|Single session (up to 3 hr) of in vivo exposure therapy plus 50 mg oral d-cycloserine administered 1 hr prior to exposure therapy session
787074|NCT01450189|B4|Baseline|Total|Total of all reporting groups
787075|NCT01450189|B3|Baseline|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
787076|NCT01450189|B2|Baseline|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787077|NCT01450189|B1|Baseline|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
787078|NCT01450189|P3|Participant Flow|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
787079|NCT01450189|P2|Participant Flow|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787080|NCT01450189|P1|Participant Flow|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
787170|NCT01450007|P3|Participant Flow|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
787171|NCT01450007|P2|Participant Flow|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
787172|NCT01450007|P1|Participant Flow|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
787081|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787082|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787083|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787084|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787085|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787086|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787087|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787088|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787089|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787173|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
787174|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
787090|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787091|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787092|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787093|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787094|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787095|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787096|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787097|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787098|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787175|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
787176|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
787099|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787100|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787101|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787102|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787103|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787104|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787105|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787106|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787107|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787177|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
788425|NCT01446289|P4|Participant Flow|Infants Placebo|Infants born from mothers who received one injection of saline solution.
787108|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787109|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787110|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787111|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787112|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787113|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787114|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787115|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787116|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787178|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
787179|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
787117|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787118|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787119|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787120|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787121|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787122|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787123|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787124|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787125|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787180|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
788426|NCT01446289|P3|Participant Flow|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
787126|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787127|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787128|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787129|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787130|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787131|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787132|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787133|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787134|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787181|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
787182|NCT01450007|O3|Outcome|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
787135|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787136|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787137|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787138|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787139|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787140|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787141|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787142|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787143|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787183|NCT01450007|O2|Outcome|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
788427|NCT01446289|P2|Participant Flow|Mothers Placebo|Pregnant women who received one injection of saline solution.
787144|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787145|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787146|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787147|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787148|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787149|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787150|NCT01450189|O3|Outcome|Behavioral Intervention Plus ARV|"The BIA arm:.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Raltegravir: raltegravir (400 mg) administered orally twice daily for 12 weeks~emtricitabine/tenofovir disoproxil fumarate: emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks"
787151|NCT01450189|O2|Outcome|Behavioral Intervention Arm Only|"Behavior- BI: Information-Motivation-Behavioral Skills Model the Information-Motivation-Behavioral Skills (IMB) Model. The 5 sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.~BI: Information-Motivation-Behavioral Skills Model: The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787152|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection."
787184|NCT01450007|O1|Outcome|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
787185|NCT01450007|E3|Reported Event|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
787153|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
787154|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787155|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
787156|NCT01450189|O1|Outcome|Combined Behavioral Intervention Arms|Both the behavioral intervention and behavioral intervention plus antiretroviral arms are combined in this outcome
787157|NCT01450189|O3|Outcome|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
787158|NCT01450189|O2|Outcome|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787159|NCT01450189|O1|Outcome|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
787160|NCT01450189|O1|Outcome|Overall|
787161|NCT01450189|O1|Outcome|Overall|
787162|NCT01450189|O1|Outcome|Overall|All arms combined
787163|NCT01450189|E3|Reported Event|Behavioral Intervention Plus Antiretrovirals (BIA)|"The BIA arm consists of the same behavioral intervention plus antiretroviral drugs (ARVs) with raltegravir (400 mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg daily) orally for 12 weeks.~ARVs with raltegravir and emtricitabine/tenofovir disoproxil fumarate: The behavioral intervention and antiretroviral (BIA) arm consists of the same behavioral intervention plus antiretroviral drugs (ARV) with raltegravir (400mg twice daily) and fixed dose combination (FDC) emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300mg daily) orally for 12 weeks."
787164|NCT01450189|E2|Reported Event|Behavioral Intervention Arm|"The BI arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.~5 counselor-delivered sessions: The behavioral intervention (BI) arm consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction."
787165|NCT01450189|E1|Reported Event|Standard Counseling Arm|"The SC arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection.~Standard HIV prevention messages: The standard counseling (SC) arm consists of a single session of standard HIV prevention messages during HIV post-test counseling. The counseling will be comparable to that given to persons with established HIV infection with supplemental information regarding the acute stage of their infection."
787166|NCT01450007|B4|Baseline|Total|Total of all reporting groups
787167|NCT01450007|B3|Baseline|Placebo|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline
787168|NCT01450007|B2|Baseline|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
787169|NCT01450007|B1|Baseline|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
788561|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
787186|NCT01450007|E2|Reported Event|Dexamethasone IV|Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml
787187|NCT01450007|E1|Reported Event|Dexamethasone Block|Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline
787188|NCT01449955|B3|Baseline|Total|Total of all reporting groups
787189|NCT01449955|B2|Baseline|Placebo|15mg Placebo administered once in pill form
787190|NCT01449955|B1|Baseline|Rapamycin|15mg Rapamycin administered once in pill form
787191|NCT01449955|P2|Participant Flow|Placebo|15mg Placebo administered once in pill form
787192|NCT01449955|P1|Participant Flow|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
787193|NCT01449955|O2|Outcome|Placebo|15 mg Placebo administered once in pill form
787194|NCT01449955|O1|Outcome|Rapamycin (e.g., Sirolimus)|15mg Rapamycin administered once in pill form
787195|NCT01449955|E2|Reported Event|Placebo|Placebo arm
787196|NCT01449955|E1|Reported Event|Rapamycin|15mg Rapamycin
787197|NCT01449929|B3|Baseline|Total|Total of all reporting groups
787198|NCT01449929|B2|Baseline|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787199|NCT01449929|B1|Baseline|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787200|NCT01449929|P2|Participant Flow|DRV 800 mg + RTV 100 mg OD|Participants received darunavir (DRV) 800 mg + ritonavir (RTV) 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787201|NCT01449929|P1|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) administered in combination with fixed-dose combination (FDC) dual nucleoside reverse transcriptase inhibitor (NRTI) therapy (either abacavir/lamivudine [ABC/3TC] or tenofovir/emtricitabine [TDF/FTC]) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
787202|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787203|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787204|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787205|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787206|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787207|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787208|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787209|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787210|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787211|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787212|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787213|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787214|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787215|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787216|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787217|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787218|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787219|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787220|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787221|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787222|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787223|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787224|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787225|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
788562|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
787226|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787227|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787228|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787229|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787230|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787231|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787232|NCT01449929|O2|Outcome|DRV 800 mg + RTV 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787233|NCT01449929|O1|Outcome|DTG 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787234|NCT01449929|E2|Reported Event|Darunavir 800 mg + Ritonavir 100 mg OD|Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787235|NCT01449929|E1|Reported Event|Dolutegravir 50 mg OD|Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
787236|NCT01449812|B4|Baseline|Total|Total of all reporting groups
787237|NCT01449812|B3|Baseline|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787238|NCT01449812|B2|Baseline|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787239|NCT01449812|B1|Baseline|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787240|NCT01449812|P3|Participant Flow|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787241|NCT01449812|P2|Participant Flow|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787242|NCT01449812|P1|Participant Flow|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787243|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787244|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787245|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787246|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787247|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
788563|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
787248|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787249|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787250|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787251|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787252|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787253|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787254|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787255|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787256|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787257|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787258|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787259|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787260|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787261|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787262|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787356|NCT01449708|B1|Baseline|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice.~patients in both groups receive antiemetic prophylaxis~postop management in both groups is similar in both groups"
787263|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787264|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787265|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787266|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787267|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787268|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787269|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787270|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787271|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787272|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787273|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787274|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787275|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787276|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787277|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787357|NCT01449708|P2|Participant Flow|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
788564|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
787278|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787279|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787280|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787281|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787282|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787283|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787284|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787285|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787286|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787287|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787288|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787289|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787290|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787291|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787292|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787358|NCT01449708|P1|Participant Flow|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
831354|NCT01289015|B3|Baseline|Total|Total of all reporting groups
787293|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787294|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787295|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787296|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787297|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787298|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787299|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787300|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787301|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787302|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787303|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787304|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787305|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787306|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787307|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787359|NCT01449708|O1|Outcome|All Study Participants|measure included all119 patients depending on surgical procedure
787360|NCT01449708|O2|Outcome|TIVA|"TIVA NoNarc (Study): - patients in both groups receive antiemetic prophylaxis~- patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively"
787308|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787309|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787310|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787311|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787312|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787313|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787314|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787315|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787316|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787317|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787318|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787319|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787320|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787321|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787322|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787361|NCT01449708|O1|Outcome|Classic/Balanced Anesthesia|"Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. This reflects our current clinical practice. (Control)~postop management in both groups is similar in both groups"
833454|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
787323|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787324|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787325|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787326|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787327|NCT01449812|O3|Outcome|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787328|NCT01449812|O2|Outcome|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787329|NCT01449812|O1|Outcome|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787330|NCT01449812|E3|Reported Event|Control Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787331|NCT01449812|E2|Reported Event|Infanrix+Hib/Poliorix 2 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787332|NCT01449812|E1|Reported Event|Infanrix+Hib/Poliorix 1 Group|Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively.
787333|NCT01449747|B3|Baseline|Total|Total of all reporting groups
787334|NCT01449747|B2|Baseline|Responder|Sitagliptin response patients
787335|NCT01449747|B1|Baseline|Non-responder|Sitagliptin non-response patients
787336|NCT01449747|P2|Participant Flow|Responder|Sitagliptin response patients
787337|NCT01449747|P1|Participant Flow|Non-responder|Sitagliptin non-response patients
787338|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
787339|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
787340|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
787341|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
787342|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
787343|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
787344|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
787345|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
787346|NCT01449747|O2|Outcome|Responder|Sitagliptin response patients
787347|NCT01449747|O1|Outcome|Non-responder|Sitagliptin non-response patients
787348|NCT01449747|E2|Reported Event|Responder|Sitagliptin response patients
787349|NCT01449747|E1|Reported Event|Non-responder|Sitagliptin non-response patients
787350|NCT01449734|B1|Baseline|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
787351|NCT01449734|P1|Participant Flow|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
787352|NCT01449734|O1|Outcome|Family Satisfaction|All 215 surveyed relatives are contained in this group, since the study was observational without intervention.
787353|NCT01449734|E1|Reported Event|Family Satisfaction|family satisfaction in the intensive care unit (ICU) and areas for improvement
787354|NCT01449708|B3|Baseline|Total|Total of all reporting groups
787355|NCT01449708|B2|Baseline|TIVA|"patients in both groups receive antiemetic prophylaxis~patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively~postop management in both groups is similar in both groups"
836501|NCT01272583|E3|Reported Event|Placebo|
787364|NCT01449708|E2|Reported Event|TIVA|patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
787365|NCT01449708|E1|Reported Event|Classic/Balanced Anesthesia|Patients will receive balanced general anesthesia including volatile anesthetics and narcotics. (Control)
787366|NCT01449682|B3|Baseline|Total|Total of all reporting groups
787367|NCT01449682|B2|Baseline|Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks~Other Name: Ozurdex PRN"
787368|NCT01449682|B1|Baseline|Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks~Other Name: Ozurdex PRN"
787369|NCT01449682|P2|Participant Flow|Active Comparator: Ozurdex q16 Weeks|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and every 16 weeks~Other Name: Ozurdex q16 weeks"
787370|NCT01449682|P1|Participant Flow|Active Comparator: Ozurdex PRN|"Drug: dexamethasone intravitreal implant Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and PRN every 16 weeks~Other Name: Ozurdex PRN"
787371|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
787372|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
787373|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
787374|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
787375|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
787376|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
787377|NCT01449682|O2|Outcome|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
787378|NCT01449682|O1|Outcome|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
787379|NCT01449682|E2|Reported Event|Ozurdex Q16 Weeks|"0.7 mg intravitreal DEX implant at Visit 1 then Q16 weeks~Ozurdex: 0.7 mg intravitreal DEX implant on first visit then every 16 weeks"
787380|NCT01449682|E1|Reported Event|Ozurdex PRN|"0.7 mg intravitreal DEX implant at Visit 1 then PRN for duration of trial (48 weeks) if evidence of fluid on OCT~Ozurdex: 0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies"
787381|NCT01449539|B1|Baseline|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres for 90 minutes at pressure. Treatment lasts about 2 hours as time is allowed for gradual pressurization and depressurization. Treated for two weeks a total of 10 HBOT treatments.
787382|NCT01449539|P1|Participant Flow|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
787383|NCT01449539|O1|Outcome|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyperbaric chamber 100% oxygen at 2.0 atmospheres (the equivalent of being under 33 feet of sea water) for 90 minutes. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each participant will be treated for two weeks for a total of 10 HBOT treatments.
787384|NCT01449539|E1|Reported Event|Hyperbaric Oxygen Therapy|Daily HBOT treatments (100% oxygen at 2.0 atmospheres (14.7) PSI for 90 minutes) for 10 days (Monday-Friday for two weeks) in conjunction with standard growth factor treatment regimens
787385|NCT01449526|B3|Baseline|Total|Total of all reporting groups
787386|NCT01449526|B2|Baseline|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787387|NCT01449526|B1|Baseline|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787388|NCT01449526|P2|Participant Flow|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787389|NCT01449526|P1|Participant Flow|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787390|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787391|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787392|NCT01449526|O2|Outcome|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787393|NCT01449526|O1|Outcome|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
788033|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
788435|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
787394|NCT01449526|E2|Reported Event|B&L PureVision Contact Lens|"The Bausch + Lomb PureVision silicone hydrogel contact lens~B&L PureVision Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787395|NCT01449526|E1|Reported Event|B&L Investigational Contact Lens|"The Bausch + Lomb investigational silicone hydrogel contact lens~B&L Investigational Contact Lens: Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly."
787396|NCT01449513|B3|Baseline|Total|Total of all reporting groups
787397|NCT01449513|B2|Baseline|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787398|NCT01449513|B1|Baseline|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787399|NCT01449513|P2|Participant Flow|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787400|NCT01449513|P1|Participant Flow|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787401|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787402|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787403|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787404|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787405|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787406|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787407|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787408|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787409|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787410|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787411|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787412|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787413|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787414|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787415|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787416|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787417|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787418|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787419|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787420|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787421|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787422|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787423|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787424|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787425|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787426|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787427|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787428|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787429|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787430|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787431|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787432|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787433|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787434|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787435|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787436|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787437|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
836502|NCT01272583|E2|Reported Event|Sitagliptin Treatment|
787438|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787439|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787440|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787441|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787442|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787443|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787444|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787445|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787446|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787447|NCT01449513|O2|Outcome|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787448|NCT01449513|O1|Outcome|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787449|NCT01449513|E2|Reported Event|Vehicle|"Vehicle of PEP005 Gel~Vehicle gel once daily on two consecutive days to an 25cm2 area"
787450|NCT01449513|E1|Reported Event|Ingenol Mebutate Gel (PEP005 Gel)|"Ingenol mebutate gel (PEP005 gel)~Ingenol mebutate gel (0.05%) once daily on two consecutive days to an 25cm2 area"
787451|NCT01449370|B26|Baseline|Total|Total of all reporting groups
787452|NCT01449370|B25|Baseline|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787453|NCT01449370|B24|Baseline|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787454|NCT01449370|B23|Baseline|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787455|NCT01449370|B22|Baseline|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787456|NCT01449370|B21|Baseline|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787457|NCT01449370|B20|Baseline|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787458|NCT01449370|B19|Baseline|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787459|NCT01449370|B18|Baseline|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787460|NCT01449370|B17|Baseline|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787461|NCT01449370|B16|Baseline|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787462|NCT01449370|B15|Baseline|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787463|NCT01449370|B14|Baseline|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787464|NCT01449370|B13|Baseline|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787465|NCT01449370|B12|Baseline|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787466|NCT01449370|B11|Baseline|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787467|NCT01449370|B10|Baseline|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787468|NCT01449370|B9|Baseline|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787469|NCT01449370|B8|Baseline|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787470|NCT01449370|B7|Baseline|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787471|NCT01449370|B6|Baseline|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787472|NCT01449370|B5|Baseline|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787473|NCT01449370|B4|Baseline|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787474|NCT01449370|B3|Baseline|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787475|NCT01449370|B2|Baseline|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787476|NCT01449370|B1|Baseline|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787477|NCT01449370|P25|Participant Flow|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787478|NCT01449370|P24|Participant Flow|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787479|NCT01449370|P23|Participant Flow|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787480|NCT01449370|P22|Participant Flow|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787481|NCT01449370|P21|Participant Flow|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787482|NCT01449370|P20|Participant Flow|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787483|NCT01449370|P19|Participant Flow|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787484|NCT01449370|P18|Participant Flow|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787485|NCT01449370|P17|Participant Flow|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787486|NCT01449370|P16|Participant Flow|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787487|NCT01449370|P15|Participant Flow|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787488|NCT01449370|P14|Participant Flow|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787489|NCT01449370|P13|Participant Flow|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787490|NCT01449370|P12|Participant Flow|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787491|NCT01449370|P11|Participant Flow|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787492|NCT01449370|P10|Participant Flow|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787493|NCT01449370|P9|Participant Flow|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787494|NCT01449370|P8|Participant Flow|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787495|NCT01449370|P7|Participant Flow|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787496|NCT01449370|P6|Participant Flow|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787497|NCT01449370|P5|Participant Flow|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787498|NCT01449370|P4|Participant Flow|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787499|NCT01449370|P3|Participant Flow|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787500|NCT01449370|P2|Participant Flow|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787501|NCT01449370|P1|Participant Flow|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787502|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787503|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787504|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787505|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787506|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787507|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787508|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787509|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787510|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787511|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787512|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787513|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787514|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787515|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787516|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787517|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787518|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787519|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787520|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787521|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787522|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787523|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
788034|NCT01448057|E2|Reported Event|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
787524|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787525|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787526|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787527|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787528|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787529|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787530|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787531|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787532|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787533|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787534|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787535|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787536|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787537|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787538|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787539|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787540|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787541|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787542|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787543|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787544|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787545|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787546|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787547|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787548|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787549|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787550|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787551|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787552|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787553|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787554|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787555|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787556|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787557|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787558|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787559|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787560|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787561|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787562|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787563|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787564|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787565|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787566|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787567|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787568|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787569|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787589|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
836503|NCT01272583|E1|Reported Event|Baseline|
787570|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787571|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787572|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787573|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787574|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787575|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787576|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787577|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787578|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787579|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787580|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787581|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787582|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787583|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787584|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787585|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787586|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787587|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787588|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
838453|NCT01265563|B6|Baseline|Total|Total of all reporting groups
787590|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787591|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787592|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787593|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787594|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787595|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787596|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787597|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787598|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787599|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787600|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787601|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787602|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787603|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787604|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787605|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787606|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787607|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787608|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787609|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787610|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787611|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787612|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787613|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787614|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787615|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787616|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787617|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787618|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787619|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787620|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787621|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787622|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787623|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787624|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787625|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787626|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787627|NCT01449370|O15|Outcome|Process B: TAK-117 1500 mg|Cohort 21: TAK-117 1500 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787648|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787628|NCT01449370|O14|Outcome|Process B: TAK-117 1200 mg|Cohort 17: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW ; Cohort 20: TAK-117 1200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787629|NCT01449370|O13|Outcome|Process B: TAK-117 900 mg|Cohort 16: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 19: TAK-117 900 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787630|NCT01449370|O12|Outcome|Process B: TAK-117 600 mg|Cohort 15: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 18: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW; Cohort 25: TAK-117 600 mg, capsules, orally, intermittently, BID every other day on MWF QW. TAK-117 was administered in all the 3 cohorts for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787631|NCT01449370|O11|Outcome|Process B: TAK-117 500 mg|Cohort 24: TAK-117 500 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787632|NCT01449370|O10|Outcome|Process B: TAK-117 400 mg|Cohort 23: TAK-117 400 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787633|NCT01449370|O9|Outcome|Process B: TAK-117 300 mg|Cohort 22: TAK-117 300 mg, capsules, orally, intermittently, BID every other day on MWF QW for first 21 days of therapy (Cycle 1). Process B in the study is referred to the study design when new CTM was introduced. FM used drug substance manufactured by an improved synthetic process.
787634|NCT01449370|O8|Outcome|Process A: TAK-117 1200 mg|Cohort 10: TAK-117 1200 mg, capsules, orally, intermittently, once every other day on MWF QW for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787635|NCT01449370|O7|Outcome|Process A: TAK-117 900 mg|Cohort 9: TAK-117 900 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 14: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787636|NCT01449370|O6|Outcome|Process A: TAK-117 600 mg|Cohort 8: TAK-117 600 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 13: TAK-117 600 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787637|NCT01449370|O5|Outcome|Process A: TAK-117 400 mg|Cohort 7: TAK-117 400 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 12: TAK-117 400 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787638|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg|Cohort 4: TAK-117 300 mg, capsules, orally, QD, continuously; Cohort 6: TAK-117 300 mg, capsules, orally, intermittently, once every other day on MWF QW. TAK-117 was administered in both the cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787639|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg|Cohort 3: TAK-117 200 mg, capsules, orally, QD, continuously; Cohort 5: TAK-117 200 mg, capsules, orally, intermittently, once every other day on MWF QW; Cohort 11: TAK-117 200 mg, capsules, orally, intermittently, QD for 3 consecutive days, on MTW QW. TAK-117 was administered in all 3 cohorts for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787640|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg|Cohort 2: TAK-117 150 mg, capsules, orally, QD, continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787641|NCT01449370|O1|Outcome|Process A: TAK-117 100 mg|Cohort 1: TAK-117 100 mg, capsules, orally, once a day (QD), continuously for first 21 days of therapy (Cycle 1). Process A included participants who received original formulation of TAK-117 capsules.
787642|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787643|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787644|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787645|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787646|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787647|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
788565|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
787649|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787650|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787651|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787652|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787653|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787654|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787655|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787656|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787657|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787658|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787659|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787660|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787661|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787662|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787663|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787664|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787665|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787666|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787667|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787668|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787669|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787670|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787671|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787672|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787673|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787674|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787675|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
842819|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
787676|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787677|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787678|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787679|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787680|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787681|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787682|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787683|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787684|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787685|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787686|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787687|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787688|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787689|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787690|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787691|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787692|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787693|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787694|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787695|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787696|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787697|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787698|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787699|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787700|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787701|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787702|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787703|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787704|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787705|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787706|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787707|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787708|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787709|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787710|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787711|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787712|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787713|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787714|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787715|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787716|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787717|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787718|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787719|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787720|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787721|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787722|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787723|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787724|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787725|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787726|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787727|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787728|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787729|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787838|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787730|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787731|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787732|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787733|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787734|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787735|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787736|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787737|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787738|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787739|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787740|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787741|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787742|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787743|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787744|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787745|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787746|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787747|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787748|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787749|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787750|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787751|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787752|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787753|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787754|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787755|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787756|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
788428|NCT01446289|P1|Participant Flow|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
787757|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787758|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787759|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787760|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787761|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787762|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787763|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787764|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787765|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787766|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787767|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787768|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787769|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787770|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787771|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787772|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787773|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787774|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787775|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787776|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787777|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787778|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787779|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787780|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787781|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787782|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787783|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787839|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787784|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787785|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787786|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787787|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787788|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787789|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787790|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787791|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787792|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787793|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787794|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787795|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787796|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787797|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787798|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787799|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787800|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787801|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787802|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787803|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787804|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787805|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787806|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787807|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787808|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787809|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787810|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787840|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787811|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787812|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787813|NCT01449370|O4|Outcome|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787814|NCT01449370|O3|Outcome|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787815|NCT01449370|O2|Outcome|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787816|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787817|NCT01449370|O25|Outcome|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787818|NCT01449370|O24|Outcome|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787819|NCT01449370|O23|Outcome|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787820|NCT01449370|O22|Outcome|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787821|NCT01449370|O21|Outcome|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787822|NCT01449370|O20|Outcome|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787823|NCT01449370|O19|Outcome|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787824|NCT01449370|O18|Outcome|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787825|NCT01449370|O17|Outcome|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787826|NCT01449370|O16|Outcome|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787827|NCT01449370|O15|Outcome|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787828|NCT01449370|O14|Outcome|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787829|NCT01449370|O13|Outcome|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787830|NCT01449370|O12|Outcome|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787831|NCT01449370|O11|Outcome|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787832|NCT01449370|O10|Outcome|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787833|NCT01449370|O9|Outcome|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787834|NCT01449370|O8|Outcome|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787835|NCT01449370|O7|Outcome|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787836|NCT01449370|O6|Outcome|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787837|NCT01449370|O5|Outcome|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
788429|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
787841|NCT01449370|O1|Outcome|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787842|NCT01449370|O6|Outcome|Process B: Total FM BID MWF QW 300-600 mg|TAK-117 300-600 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787843|NCT01449370|O5|Outcome|Process B: Total FM MTW QW 600-1500 mg|TAK-117 600-1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787844|NCT01449370|O4|Outcome|Process B: Total FM MWF QW TAK-117 600-1200 mg|TAK-117 600-1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787845|NCT01449370|O3|Outcome|Process A: Total MTW QW 200-900 mg|TAK-117 200-900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787846|NCT01449370|O2|Outcome|Process A: Total MWF QW 200-1200 mg|TAK-117 200-1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787847|NCT01449370|O1|Outcome|Process A: Total QD TAK-117 100-300 mg|TAK-117 100-300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787848|NCT01449370|E25|Reported Event|Process B: TAK-117 600 mg FM BID MWF QW|TAK-117 600 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787849|NCT01449370|E24|Reported Event|Process B: TAK-117 500 mg FM BID MWF QW|TAK-117 500 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787850|NCT01449370|E23|Reported Event|Process B: TAK-117 400 mg FM BID MWF QW|TAK-117 400 mg, capsules (Process B), orally, intermittently, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787851|NCT01449370|E22|Reported Event|Process B: TAK-117 300 mg FM Twice Daily (BID) MWF QW|TAK-117 300 mg, capsules (Process B), orally, BID every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787852|NCT01449370|E21|Reported Event|Process B: TAK-117 1500 mg FM MTW QW|TAK-117 1500 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787853|NCT01449370|E20|Reported Event|Process B: TAK-117 1200 mg FM MTW QW|TAK-117 1200 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787854|NCT01449370|E19|Reported Event|Process B: TAK-117 900 mg FM MTW QW|TAK-117 900 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787855|NCT01449370|E18|Reported Event|Process B: TAK-117 600 mg FM MTW QW|TAK-117 600 mg, capsules (Process B), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787856|NCT01449370|E17|Reported Event|Process B: TAK-117 1200 mg FM MWF QW|TAK-117 1200 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787857|NCT01449370|E16|Reported Event|Process B: TAK-117 900 mg FM MWF QW|TAK-117 900 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787858|NCT01449370|E15|Reported Event|Process B: TAK-117 600 mg Process B Capsule (FM) MWF QW|TAK-117 600 mg, capsules (Process B), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days. FM used drug substance manufactured by an improved synthetic process.
787859|NCT01449370|E14|Reported Event|Process A: TAK-117 900 mg, MTW QW|TAK-117 900 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787860|NCT01449370|E13|Reported Event|Process A: TAK-117 600 mg, MTW QW|TAK-117 600 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787861|NCT01449370|E12|Reported Event|Process A: TAK-117 400 mg, MTW QW|TAK-117 400 mg, capsules (Process A), orally, QD for 3 consecutive days, on MTW QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787862|NCT01449370|E11|Reported Event|Process A: TAK-117 200 mg, MTW QW|TAK-117 200 mg, capsules (Process A), orally, QD for 3 consecutive days, on Monday, Tuesday, and Wednesday each week (MTW QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787863|NCT01449370|E10|Reported Event|Process A: TAK-117 1200 mg, MWF QW|TAK-117 1200 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787864|NCT01449370|E9|Reported Event|Process A: TAK-117 900 mg, MWF QW|TAK-117 900 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787865|NCT01449370|E8|Reported Event|Process A: TAK-117 600 mg, MWF QW|TAK-117 600 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787866|NCT01449370|E7|Reported Event|Process A: TAK-117 400 mg, MWF QW|TAK-117 400 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787867|NCT01449370|E6|Reported Event|Process A: TAK-117 300 mg, MWF QW|TAK-117 300 mg, capsules (Process A), orally, once every other day on MWF QW up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787868|NCT01449370|E5|Reported Event|Process A: TAK-117 200 mg, MWF QW|TAK-117 200 mg, capsules (Process A), orally, once every other day on Monday, Wednesday, and Friday each week (MWF QW) up to Day 15 of each treatment cycle. Treatment cycles were repeated every 21 days.
787869|NCT01449370|E4|Reported Event|Process A: TAK-117 300 mg, QD|TAK-117 300 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787870|NCT01449370|E3|Reported Event|Process A: TAK-117 200 mg, QD|TAK-117 200 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787871|NCT01449370|E2|Reported Event|Process A: TAK-117 150 mg, QD|TAK-117 150 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787872|NCT01449370|E1|Reported Event|Process A: TAK-117 100 Milligram (mg), Once Daily (QD)|TAK-117 100 mg, capsules (Process A), orally, QD up to Day 15 of each treatment cycle. Treatment cycle were repeated every 21 days.
787873|NCT01449305|B1|Baseline|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
787874|NCT01449305|P1|Participant Flow|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
787875|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
787876|NCT01449305|O1|Outcome|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
787877|NCT01449305|E1|Reported Event|Nanoone Woman Underwear|"Nanoone negative ion of textiles, which is health material specifically designed for human body, in short distance and long time to produce negative ion, the human body really needed, it can neutralize free radical in the human body. The subjects were required to wear the Nanoone Woman Underwear during each menstrual cycle for a total of three consecutive menstrual cycles."
787878|NCT01449279|B1|Baseline|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787879|NCT01449279|P1|Participant Flow|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787880|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787881|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787893|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
788430|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
787882|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787883|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787884|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787885|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787886|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787887|NCT01449279|O1|Outcome|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787888|NCT01449279|E1|Reported Event|Ipilimumab Treatment + Radiation Therapy|"Ipilimumab (BMS-734016, MDX010, MDX-CTLA4, Yervoy) will be administered as standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments. Palliative radiation therapy to 1-2 sites of disease will start within 5 days of the first ipilimumab dose. Subjects will have follow up visits 2-4 weeks after the last ipilimumab dose and then every 3 months (±2 weeks) thereafter until progression of disease.~Ipilimumab: Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.~Radiation Therapy: Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist."
787889|NCT01449266|B1|Baseline|Dotarem®-Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
787890|NCT01449266|P1|Participant Flow|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem®: Dotarem® was administered at a dose of 0.1 mmoL/kg (0.2 mL/kg)."
787891|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
787892|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
788566|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
787894|NCT01449266|O1|Outcome|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)"
787895|NCT01449266|E1|Reported Event|Dotarem® Injected Patients|"Male or female, aged ≥18 years~• Subjects suffering from end-stage renal failure who require hemodialysis treatment for 3 times per week (or equivalent to allow overnight dialysis being rescheduled as appropriate per protocol)~Dotarem: Dotarem® was administered at a single dose of 0.1 mmoL/kg (0.2 mL/kg)."
787896|NCT01449240|B1|Baseline|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
787897|NCT01449240|P1|Participant Flow|No Investigational Treatment or Control Group|This was an observational study for the collection and study of cerebrospinal fluid (CSF) in patients with Hunter syndrome. No investigational treatment was given.
787898|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
787899|NCT01449240|O1|Outcome|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given.
787900|NCT01449240|E1|Reported Event|No Investigational Treatment or Control Group|This was an observational study for the collection and study of CSF in patients with Hunter syndrome. No investigational treatment was given. Safety analyses were performed in the Safety Population, which was defined as all patients who had undergone a procedure for CSF sample collection. This included a patient who underwent unsuccessful CSF sample collection; no CSF or urine GAG data were available for this adult patient.
787901|NCT01449006|B3|Baseline|Total|Total of all reporting groups
787902|NCT01449006|B2|Baseline|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
787903|NCT01449006|B1|Baseline|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
787904|NCT01449006|P2|Participant Flow|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
787905|NCT01449006|P1|Participant Flow|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
787906|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
787907|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
787908|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
787909|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
787910|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
787911|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
787912|NCT01449006|O2|Outcome|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
787913|NCT01449006|O1|Outcome|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
787914|NCT01449006|E2|Reported Event|Maraviroc|"Participants randomised to this arm will remain on their usual prescribed HAART regimen, with the addition of Maraviroc. Maraviroc will be prescribed according to the Product Information Sheet, with consideration given to background therapy.~Maraviroc: Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet."
787915|NCT01449006|E1|Reported Event|Standard of Care HAART Regimen|Participants randomised to this arm of the trial will remain on their usual prescribed HAART regimen.
787916|NCT01448850|B3|Baseline|Total|Total of all reporting groups
787917|NCT01448850|B2|Baseline|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787918|NCT01448850|B1|Baseline|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787919|NCT01448850|P2|Participant Flow|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787920|NCT01448850|P1|Participant Flow|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787921|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787922|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787923|NCT01448850|O1|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787924|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787925|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787926|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787927|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787928|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787929|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787930|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787931|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787932|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787933|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787934|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787935|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787936|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787937|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787938|NCT01448850|O2|Outcome|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
787939|NCT01448850|O1|Outcome|Placebo|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787940|NCT01448850|E2|Reported Event|MEDI8968 300 mg|MEDI8968 600 milligram (mg) as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 5.
787941|NCT01448850|E1|Reported Event|PLACEBO|Placebo matched to MEDI8968 as intravenous (IV) infusion on Day 1 followed by subcutaneous (SC) injection every 4 weeks up to Week 53.
787942|NCT01448707|B3|Baseline|Total|Total of all reporting groups
787943|NCT01448707|B2|Baseline|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
787944|NCT01448707|B1|Baseline|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787945|NCT01448707|P2|Participant Flow|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
787946|NCT01448707|P1|Participant Flow|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787947|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
787948|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787949|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
787950|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787951|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
787952|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
788431|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
787953|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
787954|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787955|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
787956|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787957|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
787958|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787959|NCT01448707|O2|Outcome|DRV/r + 2NRTIs|Darunavir (DRV) + ritonavir (rtv) + 2 N[t]RTIs: 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC)
787960|NCT01448707|O1|Outcome|DRV/r|Darunavir (DRV) + ritonavir (rtv): 2 tablets DRV 400 mg should be taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787961|NCT01448707|E2|Reported Event|DRV/Rtv + 2NRTIs|Darunavir (DRV), ritonavir (rtv) and 2 N[t]RTIs: 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal in combination with 2 N[t]RTIs (an investigator-selected dual combination of either abacavir (ABC), lamivudine (3TC), zidovudine (AZT), tenofovir disoproxil fumarate (TDF) or emtricitabine (FTC).
787962|NCT01448707|E1|Reported Event|DRV/Rtv MONO|Darunavir (DRV) and ritonavir (rtv): 2 tablets DRV 400 mg were taken together with 1 tablet rtv 100 mg within 30 minutes after a meal.
787963|NCT01448616|B4|Baseline|Total|Total of all reporting groups
787964|NCT01448616|B3|Baseline|Oral Placebo + Vaginal Placebo Gel|Participants received matching oral tab and placebo gel both to be used daily
787965|NCT01448616|B2|Baseline|Oral Placebo + Vaginal TFV Gel|Participants randomized to receive matching oral placebo tab once daily + tenofovir (TFV) 1% vaginal gel (40mg in 4ml) to be used daily
787966|NCT01448616|B1|Baseline|Oral TDF + Vaginal Placebo Gel|Participants randomized to receive 300mg Tenofovir Disaproxil Fumarate (TDF) 1 tab daily + the universal placebo vaginal gel (4ml) to be used daily.
787967|NCT01448616|P4|Participant Flow|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
787968|NCT01448616|P3|Participant Flow|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
787969|NCT01448616|P2|Participant Flow|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
787970|NCT01448616|P1|Participant Flow|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
787971|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
787972|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
787973|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
787974|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
787975|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg/4ml of TFV gel both to be used daily
787976|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
787977|NCT01448616|O3|Outcome|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
787978|NCT01448616|O2|Outcome|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
787979|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
787980|NCT01448616|O3|Outcome|Oral Placebo + Vaginal Placebo|"placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
787981|NCT01448616|O2|Outcome|Oral Placebo + Vaginal TFV Gel|"Tenofovir: Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator 40mg/4ml) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~placebo tablets: TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals."
788029|NCT01448057|P1|Participant Flow|Combination Product|"Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
787982|NCT01448616|O1|Outcome|Oral TDF + Vaginal Placebo Gel|"tenofovir disoproxil fumarate (TDF): Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.~placebo gel: Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects — negative or positive — on study endpoints."
787983|NCT01448616|E4|Reported Event|Placebo Oral + Placebo Vaginal Gel|This group received the matching placebos to both study products
787984|NCT01448616|E3|Reported Event|Oral Placebo + Vaginal Tenofovir 1% Gel|Participants received a matching oral placebo to study product and 40mg of TFV gel both to be used daily
787985|NCT01448616|E2|Reported Event|Oral TDF + Vaginal Placebo Gel|"Women received daily TDF tablets at 300mg + universal placebo gel for daily application"
787986|NCT01448616|E1|Reported Event|Observational Group|All enrolled participants completed 28 days of twice-daily genital swabbing for HSV DNA. Only women completing >90% of requested swabs were randomized.
787987|NCT01448525|B3|Baseline|Total|Total of all reporting groups
787988|NCT01448525|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787989|NCT01448525|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787990|NCT01448525|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787991|NCT01448525|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787992|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787993|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787994|NCT01448525|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787995|NCT01448525|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787996|NCT01448525|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787997|NCT01448525|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
787998|NCT01448486|B3|Baseline|Total|Total of all reporting groups
787999|NCT01448486|B2|Baseline|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
788000|NCT01448486|B1|Baseline|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
788001|NCT01448486|P2|Participant Flow|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
788002|NCT01448486|P1|Participant Flow|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
788003|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
788004|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
788005|NCT01448486|O2|Outcome|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
788006|NCT01448486|O1|Outcome|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
788007|NCT01448486|E2|Reported Event|Standard of Care HAART|Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART).
788008|NCT01448486|E1|Reported Event|Raltegravir|"Participants randomised to this arm will remain on their standard of care Highly Active Antiretroviral Therapy (HAART) with the addition of Raltegravir 400 mg twice daily (BID).~Raltegravir : Oral raltegravir, 400 mg tablet, twice daily for one year."
788009|NCT01448356|B1|Baseline|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
788010|NCT01448356|P1|Participant Flow|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
788011|NCT01448356|O1|Outcome|Temperature and Humidity|average of three measurements
788012|NCT01448356|O1|Outcome|Temperature and Humidity|Tear evaporation of overall surface
788013|NCT01448356|E1|Reported Event|Temperature and Humidity|All conditions were tested in a CAE chamber on the same day.
788014|NCT01448213|B3|Baseline|Total|Total of all reporting groups
788030|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
788031|NCT01448057|O1|Outcome|Arm A|Combination Product Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
788032|NCT01448057|O2|Outcome|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
788015|NCT01448213|B2|Baseline|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
788016|NCT01448213|B1|Baseline|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
788017|NCT01448213|P2|Participant Flow|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
788018|NCT01448213|P1|Participant Flow|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
788019|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
788020|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
788021|NCT01448213|O2|Outcome|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
788022|NCT01448213|O1|Outcome|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
788023|NCT01448213|E2|Reported Event|Prednisolone Acetate 1% Solution|"Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.~Prednisolone acetate: Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study."
788024|NCT01448213|E1|Reported Event|Fluorometholone 0.1% Solution|"Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.~Fluorometholone: Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study."
788025|NCT01448057|B3|Baseline|Total|Total of all reporting groups
788026|NCT01448057|B2|Baseline|Arm B|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
788027|NCT01448057|B1|Baseline|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
788028|NCT01448057|P2|Participant Flow|Paracetamol Tablets|"Paracetamol (500 mg) tablets~Paracetamol (500 mg) tablets: Paracetamol (500 mg) tablets"
842820|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
788035|NCT01448057|E1|Reported Event|Arm A|"Combination Product~Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets: Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets"
788036|NCT01448044|B3|Baseline|Total|Total of all reporting groups
788037|NCT01448044|B2|Baseline|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788038|NCT01448044|B1|Baseline|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788039|NCT01448044|P2|Participant Flow|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788040|NCT01448044|P1|Participant Flow|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788041|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788042|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788043|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788044|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788045|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788046|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788047|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788048|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788049|NCT01448044|O2|Outcome|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788050|NCT01448044|O1|Outcome|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788051|NCT01448044|E2|Reported Event|Placebo + PegIFNα2a + Ribavirin|Placebo matching daclatasvir tablets was administered orally once daily for 48 weeks. Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 48 weeks and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 48 weeks.
788432|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
788052|NCT01448044|E1|Reported Event|Daclatasvir + PegIFNα2a + Ribavirin|Daclatasvir 60 mg tablets were administered orally once daily for 24 weeks, Peginterferon alfa-2a (PegIFNα2a) 180 µg was administered subcutaneously once in a week for 24 or 48 weeks depending on response and ribavirin 400 mg (2 tablets for participants <75 kg) or 600 mg (3 tablets for participants >=75 kg) was administered orally in the morning and 600 mg (3 tablets) in the evening for 24 or 48 weeks depending on response.
788053|NCT01447927|B3|Baseline|Total|Total of all reporting groups
788054|NCT01447927|B2|Baseline|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788055|NCT01447927|B1|Baseline|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788056|NCT01447927|P2|Participant Flow|Placebo|Patients receive extended-release placebo orally (PO) once daily (QD) on week 1and BID on weeks 2-12 (every morning (QAM) and every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
788057|NCT01447927|P1|Participant Flow|Metformin|Patients receive extended-release metformin hydrochloride orally (PO) once daily (QD) on week 1, and twice daily (BID) on weeks 2-12 (every morning (QAM) every evening (QPM) on week 3) in the absence of unacceptable toxicity or disease progression.
788058|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788059|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788060|NCT01447927|O2|Outcome|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788061|NCT01447927|O1|Outcome|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788062|NCT01447927|E2|Reported Event|Metformin|Patients receive extended-release metformin hydrochloride PO QD on week 1, and BID on weeks 2-12 (QAM QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788063|NCT01447927|E1|Reported Event|Placebo|Patients receive extended-release placebo PO QD on week 1and BID on weeks 2-12 (QAM and QPM on week 3) in the absence of unacceptable toxicity or disease progression.
788064|NCT01447914|B1|Baseline|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
788065|NCT01447914|P1|Participant Flow|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
788066|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
788067|NCT01447914|O1|Outcome|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
788068|NCT01447914|E1|Reported Event|Tivantinib Treatment|Oral Tivantinib 360 mg twice daily continuously for each day of every 28 day treatment cycle (taken as three tablets of 120 mg each)
788069|NCT01447849|B5|Baseline|Total|Total of all reporting groups
788070|NCT01447849|B4|Baseline|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
788071|NCT01447849|B3|Baseline|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
788072|NCT01447849|B2|Baseline|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation (CC)received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
788073|NCT01447849|B1|Baseline|Chronic Constipation(CC) Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation (CC) received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
788074|NCT01447849|P4|Participant Flow|Controls on Placebo Then Lubiprostone|"Control group received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
788075|NCT01447849|P3|Participant Flow|Controls on Lubiprostone Then Placebo|"Control group received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
788076|NCT01447849|P2|Participant Flow|Chronic Constipation (CC)Subjects on Placebo Then Lubiprostone|"Subjects with chronic constipation received 1 week of therapy with placebo,then washed out for 1 week, then received 1 week of therapy with lubiprostone.~placebo pill: twice a day (BID) for 1 week; lubiprostone: 24mcg twice a day (BID)for 1 week"
788077|NCT01447849|P1|Participant Flow|Chronic Constipation (CC)Subjects on Lubiprostone Then Placebo|"Subjects with chronic constipation received 1 week of therapy with lubiprostone,then washed out for 1 week, then received 1 week of therapy with placebo.~lubiprostone: 24mcg twice a day (BID)for 1 week; placebo pill: twice a day (BID) for 1 week"
788078|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received lubiprostone 24mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
788079|NCT01447849|O1|Outcome|Lubiprostone 24 mcg Bid|Both controls and patients with chronic constipation received lubiprostone 24 mcg twice daily for one week and placebo pills twice daily for one week in cross over design.
788080|NCT01447849|O2|Outcome|Placebo|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
790935|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
788081|NCT01447849|O1|Outcome|Lubiprostone 24 mcg BID|Both controls and patients with chronic constipation received 1 week of therapy with lubiprostone (24 mcg twice a day)and 1 week of placebo (twice a day) in crossover design
788082|NCT01447849|E4|Reported Event|Controls on Placebo Then Lubiprostone|Control group who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
788083|NCT01447849|E3|Reported Event|Controls on Lubiprostone Then Placebo|Control group who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
788084|NCT01447849|E2|Reported Event|Chronic Constipation Subjects on Placebo Then Lubiprostone|Subjects with chronic constipation who received 1 week of therapy with placebo, then washed out for 1 week, then received 1 week of therapy with lubiprostone.
788085|NCT01447849|E1|Reported Event|Chronic Constipation Subjects on Lubiprostone Then Placebo|Subjects with chronic constipation who received 1 week of therapy with lubiprostone, then washed out for 1 week, then received 1 week of therapy with placebo.
788086|NCT01447719|B1|Baseline|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
788087|NCT01447719|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
788088|NCT01447719|O1|Outcome|Autopsy Within 1 Year of Scan|Group of subjects with valid images who came to autopsy within 1 year of scan
788089|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
788090|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
788091|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 year of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
788092|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 1 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
788093|NCT01447719|O1|Outcome|All Autopsy Population|Group of subjects with valid images who came to autopsy within 2 years of scan
788094|NCT01447719|O1|Outcome|Subjects With no or Sparse Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had no or sparse neuritic plaques at autopsy (no AD or possible AD)
788095|NCT01447719|O1|Outcome|Subjects With Moderate or Frequent Plaques at Autopsy|Group of subjects with valid images who came to autopsy within 2 years of scan and had moderate to frequent neuritic plaques at autopsy (probable AD or definite AD)
788096|NCT01447719|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
788097|NCT01447706|B3|Baseline|Total|Total of all reporting groups
788098|NCT01447706|B2|Baseline|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
788099|NCT01447706|B1|Baseline|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
788100|NCT01447706|P2|Participant Flow|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
788101|NCT01447706|P1|Participant Flow|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
788102|NCT01447706|O4|Outcome|HRG Low: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
788103|NCT01447706|O3|Outcome|HRG Low: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
788104|NCT01447706|O2|Outcome|HRG High: Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
788105|NCT01447706|O1|Outcome|HRG High: MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
788106|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
788107|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
788108|NCT01447706|O2|Outcome|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
788109|NCT01447706|O1|Outcome|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
788110|NCT01447706|E2|Reported Event|Paclitaxel|Paclitaxel: 80 mg/m2 weekly IV infusion over 60 minutes
788111|NCT01447706|E1|Reported Event|MM-121 + Paclitaxel|MM-121 (20 mg/kg weekly following a 40 mg/kg loading dose) IV infusion over 60 minutes + Paclitaxel (80 mg/m2 weekly) IV infusion over 60 minutes
788112|NCT01447576|B1|Baseline|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
788113|NCT01447576|P1|Participant Flow|Brexpiprazole +ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
788114|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
788115|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
788116|NCT01447576|O1|Outcome|Brexpiprazole+ADT|All participants received brexpiprazole 0.25 to 3.0 mg/day plus ADT.
788117|NCT01447576|E1|Reported Event|Brexpiprazole+ADT|Participants received brexpiprazole 0.25 to 3.0mg/day plus ADT.
788118|NCT01447511|B6|Baseline|Total|Total of all reporting groups
788119|NCT01447511|B5|Baseline|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788120|NCT01447511|B4|Baseline|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788433|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
788121|NCT01447511|B3|Baseline|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788122|NCT01447511|B2|Baseline|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
788123|NCT01447511|B1|Baseline|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788124|NCT01447511|P5|Participant Flow|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788125|NCT01447511|P4|Participant Flow|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788126|NCT01447511|P3|Participant Flow|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788127|NCT01447511|P2|Participant Flow|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
788128|NCT01447511|P1|Participant Flow|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788129|NCT01447511|O5|Outcome|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788130|NCT01447511|O4|Outcome|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788131|NCT01447511|O3|Outcome|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788132|NCT01447511|O2|Outcome|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
788133|NCT01447511|O1|Outcome|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788134|NCT01447511|E5|Reported Event|CYP2C9*3/*3 Genotype|Individuals with the CYP2C9*3/*3 genotype have two *3 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788135|NCT01447511|E4|Reported Event|CYP2C9*2/*3 Genotype|Individuals with the CYP2C9*2/*3 genotype have one *2 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788136|NCT01447511|E3|Reported Event|CYP2C9*1/*3 Genotype|Individuals with the CYP2C9*1/*3 genotype have one *1 allele and one *3 allele and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788137|NCT01447511|E2|Reported Event|CYP2C9*1B/*1B Haplotype|Individuals with the CYP2C9*1B/*1B haplotype have two *1B alleles and participated in the following periods: Control Period and Rifampin Period.
788138|NCT01447511|E1|Reported Event|CYP2C9*1/*1 Genotype|This genotype is considered the wild type genotype. Individuals with the CYP2C9*1/*1 genotype have two *1 alleles and participated in the following periods: Control Period, Fluconazole Period, and Rifampin Period.
788139|NCT01447446|B7|Baseline|Total|Total of all reporting groups
788140|NCT01447446|B6|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788141|NCT01447446|B5|Baseline|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788142|NCT01447446|B4|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788143|NCT01447446|B3|Baseline|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788144|NCT01447446|B2|Baseline|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788145|NCT01447446|B1|Baseline|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788146|NCT01447446|P6|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788147|NCT01447446|P5|Participant Flow|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788213|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788148|NCT01447446|P4|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788149|NCT01447446|P3|Participant Flow|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788150|NCT01447446|P2|Participant Flow|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788151|NCT01447446|P1|Participant Flow|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788152|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788153|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788154|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788155|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788156|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788157|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788158|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788159|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788160|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788161|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788162|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2b [peg-IFN Alfa-2b] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788163|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (pegylated interferon alfa-2a [peg-IFN Alfa-2a] along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788164|NCT01447446|O4|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788165|NCT01447446|O3|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788166|NCT01447446|O2|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788167|NCT01447446|O1|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788168|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788293|NCT01447225|P8|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788169|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788170|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788171|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788172|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788173|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788174|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788175|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788176|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788177|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788178|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788179|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788180|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788181|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788182|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788183|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788184|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788185|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788186|NCT01447446|O4|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788187|NCT01447446|O3|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788188|NCT01447446|O2|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788189|NCT01447446|O1|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788190|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788423|NCT01446289|B2|Baseline|Mothers Placebo|Pregnant women who received one injection of saline solution.
788191|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788192|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788193|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788194|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788195|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788196|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788197|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788198|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788199|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788200|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788201|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788202|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788203|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788204|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788205|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788206|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788207|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788208|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788209|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788210|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788211|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788212|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788424|NCT01446289|B1|Baseline|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
788214|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788215|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788216|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788217|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788218|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788219|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788220|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788221|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788222|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788223|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788224|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788225|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788226|NCT01447446|O6|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788227|NCT01447446|O5|Outcome|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788228|NCT01447446|O4|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788229|NCT01447446|O3|Outcome|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788230|NCT01447446|O2|Outcome|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788231|NCT01447446|O1|Outcome|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788232|NCT01447446|E6|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788233|NCT01447446|E5|Reported Event|Triple Therapy: Telaprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and telaprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788234|NCT01447446|E4|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2b along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788235|NCT01447446|E3|Reported Event|Triple Therapy: Boceprevir + Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving triple therapy (peg-IFN Alfa-2a along with ribavirin and boceprevir according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788434|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
788236|NCT01447446|E2|Reported Event|Dual Therapy: Peg-IFN Alfa-2b + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2b along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788237|NCT01447446|E1|Reported Event|Dual Therapy: Peg-IFN Alfa-2a + Ribavirin|Participants with CHC receiving dual therapy (peg-IFN Alfa-2a along with ribavirin according to standard of care and in line with local labeling) were followed for the duration of their treatment and for up to 24 weeks after therapy.
788238|NCT01447433|B3|Baseline|Total|Total of all reporting groups
788239|NCT01447433|B2|Baseline|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788240|NCT01447433|B1|Baseline|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788241|NCT01447433|P2|Participant Flow|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788242|NCT01447433|P1|Participant Flow|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788243|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788244|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788245|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788246|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788247|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788248|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788249|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788250|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788251|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788252|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788253|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788254|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788255|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788256|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788257|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788258|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788259|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788260|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788261|NCT01447433|O2|Outcome|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788262|NCT01447433|O1|Outcome|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788263|NCT01447433|E2|Reported Event|Control|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788264|NCT01447433|E1|Reported Event|Calcium+D|Calcium supplements provide 600mg of calcium and 125IU vitamin D per day. A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
788265|NCT01447420|B4|Baseline|Total|Total of all reporting groups
788266|NCT01447420|B3|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788267|NCT01447420|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered with peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788268|NCT01447420|B1|Baseline|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
788269|NCT01447420|P3|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788270|NCT01447420|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788557|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788271|NCT01447420|P1|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin With Genotype – CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
788272|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788273|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788274|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
788275|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788276|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788277|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
788278|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788279|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788280|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
788281|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a 180 mcg SC weekly, 48 weeks and Ribavirin 1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg, orally daily, 48 weeks
788282|NCT01447420|O3|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - TT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - TT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788283|NCT01447420|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CT|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CT, were administered peginterferon alfa-2a, 180 mcg SC per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for < 75 kg and 1,200 mg per day for >= 75 kg).
788284|NCT01447420|O1|Outcome|Peginterferon Alfa-2a Plus Ribavirin With Genotype - CC|Eligible participants with interleukin 28B (IL28-B) - RS12979860 Genotype - CC, were administered peginterferon alfa-2a, 180 micrograms (mcg) subcutaneous (SC) per week plus ribavirin orally at a dose based on the initial weight (1,000 mg per day for less than (<) 75 kg and 1,200 mg per day for greater than or equal to [>=] 75 kg).
788285|NCT01447420|E1|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants were administered peginterferon alfa-2a, 180 mcg SC weekly, 48 weeks and Ribavirin 1000 mg per day for < 75 kg and 1200 mg per day for >= 75 kg, orally daily, 48 weeks.
788286|NCT01447225|B5|Baseline|Total|Total of all reporting groups
788287|NCT01447225|B4|Baseline|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
788288|NCT01447225|B3|Baseline|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
788289|NCT01447225|B2|Baseline|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
788290|NCT01447225|B1|Baseline|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
788291|NCT01447225|P10|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
788292|NCT01447225|P9|Participant Flow|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788558|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788294|NCT01447225|P7|Participant Flow|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788295|NCT01447225|P6|Participant Flow|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788296|NCT01447225|P5|Participant Flow|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788297|NCT01447225|P4|Participant Flow|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788298|NCT01447225|P3|Participant Flow|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
788299|NCT01447225|P2|Participant Flow|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
788300|NCT01447225|P1|Participant Flow|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
788301|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
788302|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788303|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788304|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788305|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788306|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788307|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788308|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
788309|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
788310|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
788311|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
788312|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
788313|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
788314|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
788315|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
788316|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
788317|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
788318|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
788319|NCT01447225|O8|Outcome|MM-121 + Cisplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus Cisplatin 25 mg/m2
788320|NCT01447225|O7|Outcome|MM-121 + Pemetrexed: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
788321|NCT01447225|O6|Outcome|MM-121 + Carboplatin: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Plus carboplatin AUC 6
788322|NCT01447225|O5|Outcome|MM-121 + Gemcitabine: 40/20 mg/kg|MM-121 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
788323|NCT01447225|O4|Outcome|MM-121 + Cisplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus Cisplatin 20 mg/m2 or 25 mg/m2
788324|NCT01447225|O3|Outcome|MM-121 + Pemetrexed: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus pemetrexed 500 mg/m²
788325|NCT01447225|O2|Outcome|MM-121 + Carboplatin: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Plus carboplatin AUC 6
788326|NCT01447225|O1|Outcome|MM-121 + Gemcitabine: 20/12 mg/kg|MM-121 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose plus gemcitabine 1000mg/m² or 1250mg/m²
842821|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
788327|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
788328|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788329|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788330|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788331|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788332|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788333|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788334|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
788335|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
788336|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
788337|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
788338|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788339|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788340|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788341|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788342|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788343|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788344|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
788345|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
788346|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
788347|NCT01447225|O1|Outcome|MM-121 + Cabazitaxel|MTD of MM-121 + Cabazitaxel combination - NOTE: MTD of MM-121 for this combination provided in separate endpoint
788348|NCT01447225|O1|Outcome|MM-121 + Pemetrexed|MTD of combination of MM-121 + Pemetrexed - NOTE: MTD of MM-121 for this combination provided in separate endpoint
788349|NCT01447225|O1|Outcome|MM-121 + Carboplatin|MTD of the MM-121 + Carboplatin combination NOTE: MTD of MM-121 for this combination provided in separate endpoint
788350|NCT01447225|O1|Outcome|MM-121 + Gemcitabine|
788351|NCT01447225|O4|Outcome|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
788352|NCT01447225|O3|Outcome|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
788353|NCT01447225|O2|Outcome|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
788354|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Gemcitabine: administered IV at 1000 mg/m2 or 1250 mg/m2"
788355|NCT01447225|O10|Outcome|MM-121 Plus Cabazitaxel: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 25 mg/m2 IV on Day 1 of each 3-week cycle"
842822|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
788356|NCT01447225|O9|Outcome|MM-121 Plus Cabazitaxel: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788357|NCT01447225|O8|Outcome|MM-121 Plus Cabazitaxel: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12mg/kg IV maintenance doses weekly for each 3-week cycle~Cabazitaxel: 20 mg/m2 IV on Day 1 of each 3-week cycle"
788358|NCT01447225|O7|Outcome|MM-121 Plus Pemetrexed: Cohort 2|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788359|NCT01447225|O6|Outcome|MM-121 Plus Pemetrexed: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance dose weekly for every 3-week cycle~Pemetrexed at 500 mg/m2 IV on Day 1 of every 3 week cycle"
788360|NCT01447225|O5|Outcome|MM-121 Plus Carboplatin: Cohort 3|"MM-121: 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788361|NCT01447225|O4|Outcome|MM-121 Plus Carboplatin: Cohort 2|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 5 Day 1 of every 3 week cycle"
788362|NCT01447225|O3|Outcome|MM-121 Plus Carboplatin: Cohort 1|"MM-121: 20 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 12 mg/kg IV maintenance doses weekly for each 3-week cycle~Carboplatin at AUC 6 Day 1 of every 3 week cycle"
788363|NCT01447225|O2|Outcome|MM-121 Plus Gemcitabine: Cohort 2|"MM-121 40 mg/kg IV one-time loading dose on Cycle 1, Week 1 followed by 20 mg/kg IV maintenance doses weekly for each 3-week cycle~Gemcitabine: 1000 mg/m2 IV on Day 1 And Day 8 of each 3-week cycle"
788364|NCT01447225|O1|Outcome|MM-121 Plus Gemcitabine: Cohort 1|"MM-121 20 mg/kg one-time loading dose on Cycle 1, Week 1 followed 12 mg/kg IV maintenance doses weekly for 3-week cycles~gemcitabine 1000 mg/m2 IV on Days 1 and 8 of each 3-week cycle"
788365|NCT01447225|E4|Reported Event|MM-121 Plus Cabazitaxel|"escalating doses of MM-121 and cabazitaxel on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Cabazitaxel: administered IV at 20 mg/m2 or 25 mg/m2"
788366|NCT01447225|E3|Reported Event|MM-121 Plus Pemetrexed|"pemetrexed at 500 mg/m2 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Pemetrexed: administered IV at 500 mg/m2"
788367|NCT01447225|E2|Reported Event|MM-121 Plus Carboplatin|"carboplatin at AUC 6 with escalating doses of MM-121 on Day 1 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV~Carboplatin: administered at AUC 6"
788368|NCT01447225|E1|Reported Event|MM-121 Plus Gemcitabine|"escalating doses of MM-121 and gemcitabine on Day 1 and Day 8 of every 3 week cycle~MM-121: MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV"
788369|NCT01447121|B1|Baseline|Intended Users of the System|Study results from 2 subjects were excluded from all data analysis, because study staff inadvertently performed study tasks that could be considered 'training' them. (According to protocol, training was not allowed.)
788370|NCT01447121|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
788371|NCT01447121|O1|Outcome|Study Staff|Study staff also used the investigational Blood Glucose Monitoring System (BGMS) (Tatus/Tradewind Investigational Blood Glucose Meter)
788372|NCT01447121|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
788373|NCT01447121|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.~Tatsu/Tradewind Investigational BG Monitoring System : Tradewind is a Bayer investigational meter that used an investigational sensor."
788374|NCT01447017|B3|Baseline|Total|Total of all reporting groups
788375|NCT01447017|B2|Baseline|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
788376|NCT01447017|B1|Baseline|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
788377|NCT01447017|P2|Participant Flow|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
788378|NCT01447017|P1|Participant Flow|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
788379|NCT01447017|O2|Outcome|Placebo for DPK-060 Ear Drops|Patients randomized to treatment with Placebo for DPK-060 ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
788380|NCT01447017|O1|Outcome|DPK-060 2% Ear Drops|Patients randomized to treatment with DPK-060 2% ear drops (0.3 mL/pipette, 3 times daily for 7 or 10 days, as applicable)
788381|NCT01447017|E2|Reported Event|Placebo for DPK-060 Ear Drops|Placebo for DPK-060 ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
788382|NCT01447017|E1|Reported Event|DPK-060 2% Ear Drops|DPK-060 2% ear drops, 0.3 mL/pipette, 3 times daily for 7 or 10 days (as applicable).
788383|NCT01446796|B1|Baseline|Continuous RV Pacing|Study terminated early due to recruitment
788384|NCT01446796|P2|Participant Flow|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
788385|NCT01446796|P1|Participant Flow|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
842823|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
788386|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
788387|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
788388|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
788389|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
788390|NCT01446796|O2|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
788391|NCT01446796|O1|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
788392|NCT01446796|O2|Outcome|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
788393|NCT01446796|O1|Outcome|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
788394|NCT01446796|E2|Reported Event|Continuous RV Pacing|Devices will be programmed to continuous dual chamber pacing at a DDD (dual chamber dual pacing) setting with base rate ≥ 90 bpm (not to exceed 100 bpm) to achieve a majority (>80%) of paced right ventricular beats
788395|NCT01446796|E1|Reported Event|Native Conduction|Devices will be programmed to continuous atrial pacing at an AAI (atrial inhibited pacing) setting with base rate 90 bpm. Patients will not receive ventricular pacing.
788396|NCT01446705|B3|Baseline|Total|Total of all reporting groups
788397|NCT01446705|B2|Baseline|Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
788398|NCT01446705|B1|Baseline|Control (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
788399|NCT01446705|P2|Participant Flow|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
788400|NCT01446705|P1|Participant Flow|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VA Medical Center (VAMC) for whom information exchange has not been activated.
788401|NCT01446705|O2|Outcome|Enrolled in HIE|Patients in this arm represent Veterans seen at the Indianapolis VAMC enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
788402|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this arm represent Veterans seen at the Indianapolis VAMC NOT enrolled in VLER who have readily identifiable cost information. The analysis will determine any difference among baseline variables
788403|NCT01446705|O2|Outcome|Enrolled in HIE|This group represents veterans were enrolled in Health Information Exchange via VLER
788404|NCT01446705|O1|Outcome|Control (Not Enrolled)|Patients in this group were not enrolled in Health Information Exchange.
788405|NCT01446705|E2|Reported Event|Patients Enrolled in HIE|"Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has been activated by the patient choosing to opt-in."
788406|NCT01446705|E1|Reported Event|Controls (Not Enrolled)|Patients in this arm will represent Veterans seen at the Indianapolis VAMC for whom information exchange has not been activated.
788407|NCT01446419|B3|Baseline|Total|Total of all reporting groups
788408|NCT01446419|B2|Baseline|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
788409|NCT01446419|B1|Baseline|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
788410|NCT01446419|P2|Participant Flow|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
788411|NCT01446419|P1|Participant Flow|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
788412|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
788413|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
788414|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
788415|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
788416|NCT01446419|O2|Outcome|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
788417|NCT01446419|O1|Outcome|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
788418|NCT01446419|E2|Reported Event|Sham Treatment|Sham Treatment: Percutaneous access to the lumbar vertebra, no RF ablation delivered.
788419|NCT01446419|E1|Reported Event|Intracept Treatment|Intracept Treatment: Percutaneous access and RF ablation of the basivertebral nerve within the lumbar vertebral body to treat chronic axial low back.
788420|NCT01446289|B5|Baseline|Total|Total of all reporting groups
788421|NCT01446289|B4|Baseline|Infants Placebo|Infants born from mothers who received one injection of saline solution.
788422|NCT01446289|B3|Baseline|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
842824|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
788437|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
788438|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
788439|NCT01446289|O2|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
788440|NCT01446289|O1|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
788441|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
788442|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
788443|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
788444|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
788445|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
788446|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
788447|NCT01446289|O4|Outcome|Infants Placebo|Infants born from mothers who received one injection of saline solution.
788448|NCT01446289|O3|Outcome|Infants GBS|Infants born from mothers who received one injection of GBS vaccine.
788449|NCT01446289|O2|Outcome|Mothers Placebo|Pregnant women who received one injection of saline solution.
788450|NCT01446289|O1|Outcome|Mothers GBS|Pregnant women who received one injection of GBS vaccine.
788451|NCT01446289|E4|Reported Event|Infants Placebo|Infants born from mothers who received one injection of saline solution.
788452|NCT01446289|E3|Reported Event|Infants GBS|Infants born from mothers who received one dose of GBS vaccine.
788453|NCT01446289|E2|Reported Event|Mothers Placebo|Pregnant women who received one injection of saline solution.
788454|NCT01446289|E1|Reported Event|Mothers GBS|Pregnant women who received one dose of GBS vaccine.
788455|NCT01446250|B1|Baseline|All Enrolled Participants|Analysis was performed on all enrolled participants.
788456|NCT01446250|P4|Participant Flow|No Intervention|Participants who had an End of Treatment Response (ETR) were followed-up for 24 weeks after the last dose of BOC triple therapy (in Treatment Period 2) and participants who did not respond for any reason or discontinued the treatment early were followed-up for 12 weeks after the last dose of BOC (in Treatment Period 2).
788457|NCT01446250|P3|Participant Flow|PEGinf + RBV|Participants who received ALV in Treatment Period 1 were put on clinical hold but continued receiving PEGinf and RBV for 4 weeks, after which they switched to BOC triple therapy in Treatment Period 2.
788458|NCT01446250|P2|Participant Flow|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
788459|NCT01446250|P1|Participant Flow|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
788460|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
788461|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
788462|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
788463|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
788464|NCT01446250|O2|Outcome|Boceprevir|Participants randomized to Treatment C received Boceprevir (BOC) 800 mg three times daily (TID) with PEGinf and RBV in Treatment Period 1. Participants who received ALV in Treatment Period 1 and were put on clinical hold for 4 weeks, received BOC 800 mg TID with PEGinf and RBV in Treatment Period 2.
788465|NCT01446250|O1|Outcome|Alisporivir|Participants randomized to Treatment A and B received Alisporivir (ALV) 400 mg twice daily (BID) with Peginterferon alfa-2a (PEGinf) and Ribavirin (RBV) in Treatment Period 1.
788466|NCT01446250|E4|Reported Event|No Intervention|AE was discovered while taking no intervention.
788467|NCT01446250|E3|Reported Event|PEGinf + RBV|AE occurred while taking only PEGinf + RBV.
788468|NCT01446250|E2|Reported Event|Boceprevir|AE occurred while taking Boceprevir + PEGinf + RBV.
788469|NCT01446250|E1|Reported Event|Alisporivir|Adverse event (AE) occurred while taking Alisporivir + PEGinf + RBV.
788470|NCT01446237|B1|Baseline|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
788471|NCT01446237|P1|Participant Flow|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (Benzoyl Peroxide[BPO]) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 percent salicylic acid [SA]) each evening over an application period of 12 weeks.
788472|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
788559|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788514|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
789171|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
788473|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
788474|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
788475|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
788476|NCT01446237|O1|Outcome|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
788477|NCT01446237|E1|Reported Event|MaxClarity|Participants were instructed to apply MaxClarity Foam Deep Cleanser (2.5 percent (BPO) and MaxClarity Foam Advanced Acne Treatment (2.5 percent BPO) to the face each morning and MaxClarity Foam Deep Cleanser (2.5 percent BPO) and MaxClarity Foam Rejuvenating Toner (0.5 SA) each evening over an application period of 12 weeks.
788478|NCT01446003|B1|Baseline|All Participants|
788479|NCT01446003|P2|Participant Flow|Placebo-MK-8457 Sequence|Each treatment will be separated by a 10-day washout
788480|NCT01446003|P1|Participant Flow|MK-8457-Placebo Sequence|Each treatment will be separated by a 10-day washout
788481|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for MK-8457 for 10 days
788482|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788483|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for MK-8457 for 10 days
788484|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788485|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788486|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788487|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788488|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788489|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for MK-8457 for 10 days
788490|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788491|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for MK-8457 for 10 days
788492|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788493|NCT01446003|O2|Outcome|Placebo|Participants received Placebo for MK-8457 for 10 days
788494|NCT01446003|O1|Outcome|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788495|NCT01446003|E2|Reported Event|Placebo|Participants received Placebo for MK-8457 for 10 days
788496|NCT01446003|E1|Reported Event|MK-8457 100 mg BID|Participants received MK-8457 100 mg BID for 10 days
788497|NCT01445951|B4|Baseline|Total|Total of all reporting groups
788498|NCT01445951|B3|Baseline|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788499|NCT01445951|B2|Baseline|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788500|NCT01445951|B1|Baseline|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788501|NCT01445951|P3|Participant Flow|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788502|NCT01445951|P2|Participant Flow|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788503|NCT01445951|P1|Participant Flow|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788504|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788505|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788506|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788507|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788508|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788509|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788510|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788511|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788512|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788513|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788560|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788515|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788516|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788517|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788518|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788519|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788520|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788521|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788522|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788523|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788524|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788525|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788526|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788527|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788528|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788529|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788530|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788531|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788532|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788533|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788534|NCT01445951|O3|Outcome|Insulin Aspart + Basal Insulin|Subcutaneous insulin aspart plus subcutaneous basal insulin, doses individualized for each patient
788535|NCT01445951|O2|Outcome|Technosphere Insulin-MedTone + Basal Insulin|Technosphere Insulin delivered via the MedTone C Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788536|NCT01445951|O1|Outcome|Technosphere Insulin-Gen2 + Basal Insulin|Technosphere Insulin delivered via the Gen2 Inhaler plus subcutaneous basal insulin, doses individualized for each patient
788537|NCT01445951|E3|Reported Event|Aspart Group|"Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry~Insulin Aspart in combination with a basal insulin: Injectable insulin"
788538|NCT01445951|E2|Reported Event|Technosphere® Insulin With MedTone C Inhaler|"Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere® Insulin with MedTone C Inhaler: Inhalation Powder and injectable insulin"
788539|NCT01445951|E1|Reported Event|Technosphere ® Insulin-Gen2 Group|"Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry~Technosphere ®Insulin with Gen2 Inhaler: Inhalation Powder and injectable insulin"
788540|NCT01445873|B1|Baseline|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788541|NCT01445873|P1|Participant Flow|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788542|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788543|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788544|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788545|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788546|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788547|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788548|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788549|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788550|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788551|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788552|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788553|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788554|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788555|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788556|NCT01445873|O1|Outcome|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788567|NCT01445873|E1|Reported Event|Sitaxentan (Thelin)|Duration and dose as prescribed in clinical practice.
788568|NCT01445847|B3|Baseline|Total|Total of all reporting groups
788569|NCT01445847|B2|Baseline|Placebo|Placebo group received 1 mL/10 kg bolus once inhalational gas (Desflurane) is discontinued
788570|NCT01445847|B1|Baseline|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
788571|NCT01445847|P2|Participant Flow|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
788572|NCT01445847|P1|Participant Flow|Lidocaine|Lidocaine group received 1 mL/10 kg (or 1 mg/kg) bolus once inhalational gas (Desflurane) is discontinued
788573|NCT01445847|O2|Outcome|Placebo|Placebo group received 1 ml per 10 kg (0.2 mL per 2 kg) bolus once inhalational gas (Desflurane) is discontinued
788574|NCT01445847|O1|Outcome|Lidocaine|Lidocaine group received 1 mg per kg (1mL per 10kg) bolus once inhalational gas (Desflurane) is discontinued
788575|NCT01445847|E2|Reported Event|Placebo|Placebo group received 1 ml per 10 kg bolus once inhalational gas (Desflurane) is discontinued
788576|NCT01445847|E1|Reported Event|Lidocaine|Lidocaine group received 1 ml/10 kg (or 1mg/kg) bolus once inhalational gas (Desflurane) is discontinued
788577|NCT01445769|B1|Baseline|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788578|NCT01445769|P1|Participant Flow|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported Patients' Global Impression of Change (PGIC) score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788579|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥ 100 x 10^9/L at week 12 or ≥ 150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788580|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788581|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788582|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788583|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788584|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788598|NCT01445678|P2|Participant Flow|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days Of the 979 treated subjects in the integrated analysis set, 497 received meropenem.
788599|NCT01445678|P1|Participant Flow|CXA-201 and Metronidazole as Treatment for cIAI|"CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days.~Of the 979 treated subjects in the integrated analysis set, 482 received CXA."
788601|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788585|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788586|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788587|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788588|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788589|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788590|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788591|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788592|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
788593|NCT01445769|O1|Outcome|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia. Only the subjects who had Week 24 spleen volume data are summarized.
788594|NCT01445769|E1|Reported Event|Ruxolitinib|Participants initially received ruxolitinib 10 mg twice a day (bid). Dose increases of 5 mg bid were permitted at Weeks 12 and 18 for subjects who did not meet criteria for or have a dose hold over the prior 6 weeks, had a platelet count ≥100 x 10^9/L at week 12 or ≥150 x 10^9/L at week 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length had been reduced by less than 40% at that visit relative to Baseline. The maximum dose was 15 mg BID at Week 12 and 20 mg bid at Week 18. There were also protocol-required dose decreases for protocol-defined anemia and thrombocytopenia.
788595|NCT01445678|B3|Baseline|Total|Total of all reporting groups
788596|NCT01445678|B2|Baseline|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788597|NCT01445678|B1|Baseline|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788600|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788602|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788603|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788604|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788605|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788606|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788607|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788608|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788609|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788610|NCT01445678|O2|Outcome|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788611|NCT01445678|O1|Outcome|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788612|NCT01445678|E2|Reported Event|Meropenem as Treatment for cIAI|Meropenem: Meropenem IV infusion (1000mg q8h) for 4-14 days
788613|NCT01445678|E1|Reported Event|CXA-201 and Metronidazole as Treatment for cIAI|CXA-201 and metronidazole: CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
788614|NCT01445652|B3|Baseline|Total|Total of all reporting groups
788615|NCT01445652|B2|Baseline|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
788616|NCT01445652|B1|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
788617|NCT01445652|P2|Participant Flow|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
788618|NCT01445652|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
788619|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
788620|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
788621|NCT01445652|O2|Outcome|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
788622|NCT01445652|O1|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
788623|NCT01445652|E2|Reported Event|Spectacles|Spectacles per current prescription worn a minimum of five days per week, eight hours per day, for six months
788624|NCT01445652|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily disposable basis a minimum of five days per week, eight hours per day, for six months
788625|NCT01445626|B1|Baseline|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788626|NCT01445626|P1|Participant Flow|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788627|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788628|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788629|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788630|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788631|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788632|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788633|NCT01445626|O1|Outcome|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788634|NCT01445626|E1|Reported Event|All Participants|Patients who received at least two OZURDEX® (dexamethasone intravitreal implant) injections.
788635|NCT01445613|B1|Baseline|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788636|NCT01445613|P1|Participant Flow|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788637|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788638|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
789054|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
788713|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~ T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788639|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788640|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788641|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
788642|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
788643|NCT01445613|O2|Outcome|In Non-octogenarian Group|Non-octogenarian: A person who is less than 80 years old.
788644|NCT01445613|O1|Outcome|In Octogenarian Group|Octogenarian: A person with age >= 80 years.
788645|NCT01445613|O2|Outcome|In Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
788646|NCT01445613|O1|Outcome|In Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or TIA (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
788647|NCT01445613|O2|Outcome|Composite of Peri-procedural DS in the Asymptomatic Group|Asymptomatic Subject: Subject does not have a history of symptoms, stroke or TIA (hemispheric or ocular/Amaurosis Fugax) in the hemisphere supplied by the target vessel in the last 180 days.
788648|NCT01445613|O1|Outcome|Composite of Peri-procedural DS in the Symptomatic Group|Symptomatic subject: Subject with Amaurosis Fugax (a temporary (≤10 minutes) loss of vision in one eye due to insufficient blood flow to the retina), stroke or transient ischemic attack (TIA) (hemispheric or ocular) in the hemisphere supplied by the target vessel in the last 180-days prior to procedure.
788649|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788650|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788651|NCT01445613|O1|Outcome|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788652|NCT01445613|E1|Reported Event|RX Acculink Carotid Stent System (RX Acculink)|"Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.~RX Acculink Carotid Stent System (RX Acculink): Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink."
788653|NCT01445548|B1|Baseline|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788654|NCT01445548|P1|Participant Flow|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788655|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788656|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788657|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788658|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788659|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788660|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788661|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788662|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788690|NCT01444924|E2|Reported Event|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
788663|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788664|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788665|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788666|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788667|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788668|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788669|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788670|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788671|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788672|NCT01445548|O1|Outcome|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788673|NCT01445548|E1|Reported Event|Sirolimus|"Participants initially received a 20 μL (440 μg) intravitreal injection sirolimus in the study eye at baseline and every two months thereafter unless contraindicated.~As of September 2012, sirolimus intravitreal injections were no longer administered to participants."
788674|NCT01445028|B3|Baseline|Total|Total of all reporting groups
788675|NCT01445028|B2|Baseline|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
788676|NCT01445028|B1|Baseline|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
788677|NCT01445028|P2|Participant Flow|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
788678|NCT01445028|P1|Participant Flow|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
788679|NCT01445028|O2|Outcome|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
788680|NCT01445028|O1|Outcome|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
788681|NCT01445028|E2|Reported Event|Recurrent RD Associated With PVR|"Oral isotretinoin on recurrent retinal detachment associated with Proliferative vitreoretinopathy~Isotretinoin: Isotretinoin 20mg daily for 12 weeks"
788682|NCT01445028|E1|Reported Event|Primary, High-risk Retinal Detachment|Isotretinoin: Isotretinoin 20mg daily for 12 weeks
788683|NCT01444924|B3|Baseline|Total|Total of all reporting groups
788684|NCT01444924|B2|Baseline|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
788685|NCT01444924|B1|Baseline|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
788686|NCT01444924|P2|Participant Flow|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
788687|NCT01444924|P1|Participant Flow|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
788688|NCT01444924|O2|Outcome|Placebo|"TAP block with placebo placed prior to surgery~Placebo: The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline."
788689|NCT01444924|O1|Outcome|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
788712|NCT01444781|O2|Outcome|Group 2: DTaP-IPV-HepB-PRP~Tprimary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788691|NCT01444924|E1|Reported Event|Bupivicaine|"TAP block with bupivicaine/epinephrine placed prior to surgery.~Bupivicaine: The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis"
788692|NCT01444898|B1|Baseline|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788693|NCT01444898|P1|Participant Flow|Exenatide|All subjects enrolled in this study will be given Exenatide for 6 months. The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
788694|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788695|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788696|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788697|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788698|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788699|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788700|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788701|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788702|NCT01444898|O1|Outcome|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788703|NCT01444898|E1|Reported Event|Exenatide|"All subjects enrolled in this study will be given Exenatide for 6 months.~Exenatide: The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months)."
788704|NCT01444781|B4|Baseline|Total|Total of all reporting groups
788705|NCT01444781|B3|Baseline|Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster Group.|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
788706|NCT01444781|B2|Baseline|DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788707|NCT01444781|B1|Baseline|DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster Group|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
788708|NCT01444781|P3|Participant Flow|Group3: Infanrix Hexa Primary/DTaPIPV-Hep B PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788709|NCT01444781|P2|Participant Flow|Group2: DTaPIPV-Hep B-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788710|NCT01444781|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788711|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788714|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788715|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788716|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788717|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788718|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788719|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788720|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788721|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788722|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788723|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788724|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788725|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788726|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788727|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788728|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788729|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
788730|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788731|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
788732|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788733|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788734|NCT01444781|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788735|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
788736|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788737|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
788738|NCT01444781|O3|Outcome|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788739|NCT01444781|O2|Outcome|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788740|NCT01444781|O1|Outcome|Group 1: DTaP-IPV Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788741|NCT01444781|O3|Outcome|Group 3Infanrix Hexa Primary/DTaP IPV Hep B PRP T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP IPV Hep B PRP T and one dose of PCV7
788742|NCT01444781|O2|Outcome|Group 2DTaP IPV Hep B PRP T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
789055|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
788743|NCT01444781|O1|Outcome|Group 1: DTaP IPV Hep B PRP T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP IPV Hep B PRP T received one dose of DTaP IPV Hep B PRP T vaccine and one dose of Prevenar (PCV7)
788744|NCT01444781|E3|Reported Event|Group 3:Infanrix Hexa Primary/DTaP-IPV-HepB-PRP~T+PCV7 Booster|Participants who were previously primed with Infanrix Hexa vaccine received one dose of DTaP-IPV-Hep B-PRP~T and one dose of PCV7
788745|NCT01444781|E2|Reported Event|Group 2:DTaP-IPV-HepB-PRP~T Primary/Infanrix Hexa+PCV7 Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of Infanrix Hexa vaccine and one dose of PCV7.
788746|NCT01444781|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T + Prevenar™ Primary and Booster|Participants who were previously primed with DTaP-IPV-Hep B-PRP~T received one dose of DTaP-IPV-Hep B-PRP~T vaccine and one dose of Prevenar (PCV7)
788747|NCT01444651|B3|Baseline|Total|Total of all reporting groups
788748|NCT01444651|B2|Baseline|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788749|NCT01444651|B1|Baseline|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788750|NCT01444651|P2|Participant Flow|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788751|NCT01444651|P1|Participant Flow|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788752|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788753|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788754|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788755|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788756|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788757|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788758|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788759|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788760|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788761|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788762|NCT01444651|O2|Outcome|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788763|NCT01444651|O1|Outcome|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788764|NCT01444651|E2|Reported Event|Placebo|"Placebo tablet taken by mouth once a day for 3 months~Placebo: Placebo tablet taken by mouth once a day for 3 months"
788765|NCT01444651|E1|Reported Event|Tadalafil|"20 mg Tadalafil tablet taken by mouth once a day for 3 months~Tadalafil: 20 mg Tadalafil taken once a day for 3 months"
788766|NCT01444456|B1|Baseline|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
788767|NCT01444456|P1|Participant Flow|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
788768|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
788769|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
788770|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
788771|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
788772|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
788773|NCT01444456|O1|Outcome|Darbepoetin Alfa|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) to treat symptomatic anemia according to routine institutional practice.
788774|NCT01444456|E1|Reported Event|Darbepoetin Alfa or Other ESA|Participants receiving systemic chemotherapy for solid tumors who also received darbepoetin alfa (Aranesp®) or another erythropoiesis-stimulating agent (ESA) to treat symptomatic anemia according to routine institutional practice.
788775|NCT01444430|B3|Baseline|Total|Total of all reporting groups
788776|NCT01444430|B2|Baseline|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788777|NCT01444430|B1|Baseline|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
789037|NCT01443494|E1|Reported Event|Septic Shock Patients Despite EGDT|Patients requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
788887|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788778|NCT01444430|P2|Participant Flow|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788779|NCT01444430|P1|Participant Flow|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788780|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788781|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788782|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788783|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788784|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788785|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788786|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788787|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788788|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788789|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788790|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788791|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788792|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788793|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788794|NCT01444430|O2|Outcome|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788795|NCT01444430|O1|Outcome|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788796|NCT01444430|E2|Reported Event|Budesonide|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening).
788797|NCT01444430|E1|Reported Event|Symbicort|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening).
788798|NCT01444417|B3|Baseline|Total|Total of all reporting groups
788799|NCT01444417|B2|Baseline|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788800|NCT01444417|B1|Baseline|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788801|NCT01444417|P2|Participant Flow|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788802|NCT01444417|P1|Participant Flow|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788803|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788804|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788805|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788806|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788807|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788808|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788809|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788810|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788811|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788812|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788813|NCT01444417|O2|Outcome|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788814|NCT01444417|O1|Outcome|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788815|NCT01444417|E2|Reported Event|Romiplostim|Participants received once weekly subcutaneous romiplostim for 24 weeks at a starting dose of 1 µg/kg; weekly dose increases continued in increments of 1 µg/kg/week to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L.
788816|NCT01444417|E1|Reported Event|Placebo|Participants received weekly subcutaneous placebo for 24 weeks.
788817|NCT01444391|B1|Baseline|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788818|NCT01444391|P1|Participant Flow|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788819|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788820|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788821|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788822|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788823|NCT01444391|O1|Outcome|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788824|NCT01444391|E1|Reported Event|Tympanostomy Tube Placement|Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
788825|NCT01444378|B1|Baseline|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788826|NCT01444378|P1|Participant Flow|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788827|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788828|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788829|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788830|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788831|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788832|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788833|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788834|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788835|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788836|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788837|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788838|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788839|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788840|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788841|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788842|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788843|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788844|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788845|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788846|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788847|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788848|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788849|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788850|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788851|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788852|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788853|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788854|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788855|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788856|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788857|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788858|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788859|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788860|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788861|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788862|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788863|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788864|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788865|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788866|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788867|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788868|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788869|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788870|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788871|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788872|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788873|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788874|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788875|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788876|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788877|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788878|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788879|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788880|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788881|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788882|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788883|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788884|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788885|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788886|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
789038|NCT01443403|B5|Baseline|Total|Total of all reporting groups
842825|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
788888|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788889|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788890|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788891|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788892|NCT01444378|O3|Outcome|Stair Climbing Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788893|NCT01444378|O2|Outcome|Walking Speed Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788894|NCT01444378|O1|Outcome|Walking Distance Score|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788895|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788896|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788897|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788898|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788899|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788900|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788901|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788902|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788903|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788904|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788905|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788906|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788907|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788908|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788909|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788910|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788911|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788912|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788913|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788914|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
789056|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
790579|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
788915|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788916|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788917|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788918|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788919|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788920|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788921|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788922|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788923|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788924|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788925|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788926|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788927|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788928|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788929|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788930|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788931|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788932|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788933|NCT01444378|O1|Outcome|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788934|NCT01444378|E1|Reported Event|Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems: Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
788935|NCT01444300|B3|Baseline|Total|Total of all reporting groups
788936|NCT01444300|B2|Baseline|Placebo|Placebo: placebo pill, twice daily (bid), for 12 weeks
788937|NCT01444300|B1|Baseline|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
788938|NCT01444300|P2|Participant Flow|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
788939|NCT01444300|P1|Participant Flow|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
788940|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for for 12 weeks
788941|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
788942|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
788943|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
788944|NCT01444300|O2|Outcome|Placebo|Placebo: placebo pill, twice daily (bid), pill taken by mouth for 12 weeks
788945|NCT01444300|O1|Outcome|Dalfampridine|Dalfampridine: 10mg, twice daily (bid), pill taken by mouth for 12 weeks
788946|NCT01444300|E2|Reported Event|Placebo|Placebo: placebo pill, twice daily, for 12 weeks
788947|NCT01444300|E1|Reported Event|Dalfampridine|Dalfampridine: 10mg, twice daily, pill taken by mouth for 12 weeks
788948|NCT01444287|B1|Baseline|All Subjects|Subjects who were enrolled and randomized to a trial arm.
789039|NCT01443403|B4|Baseline|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
842826|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
788949|NCT01444287|P1|Participant Flow|All Study Participants|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations. The four arms were Spectacles (no contact lenses), Narafilcon B, Polymacon A, and Lotrafilcon A, in random order during the sessions.
788950|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788951|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788952|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788953|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788954|NCT01444287|O4|Outcome|Lotrafilcon A (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788955|NCT01444287|O3|Outcome|Polymacon (+ Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788956|NCT01444287|O2|Outcome|Narafilcon B (Test)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788957|NCT01444287|O1|Outcome|Spectacles No Lenses (Control)|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788958|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788959|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788960|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788961|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788962|NCT01444287|O4|Outcome|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788963|NCT01444287|O3|Outcome|Polymacon|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788964|NCT01444287|O2|Outcome|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788965|NCT01444287|O1|Outcome|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788966|NCT01444287|E4|Reported Event|Lotrafilcon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788967|NCT01444287|E3|Reported Event|Polymacon A|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788968|NCT01444287|E2|Reported Event|Narafilcon B|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788969|NCT01444287|E1|Reported Event|Spectacles No Lenses|Assigned in random order during one of four 8 hour sessions on four separate days, in one of 24 possible order combinations.
788970|NCT01444092|B1|Baseline|Entocort|Entocort™ EC 9/6/3 mg
788971|NCT01444092|P1|Participant Flow|Entocort|Entocort™ EC 9/6/3 mg
788972|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
788973|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
788974|NCT01444092|O1|Outcome|Entocort|Entocort™ EC 9/6/3 mg
788975|NCT01444092|E1|Reported Event|Entocort|Entocort™ EC 9/6/3 mg
788976|NCT01443923|B3|Baseline|Total|Total of all reporting groups
788977|NCT01443923|B2|Baseline|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788978|NCT01443923|B1|Baseline|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788979|NCT01443923|P2|Participant Flow|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788980|NCT01443923|P1|Participant Flow|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788981|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788982|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788983|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788984|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788985|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788986|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788987|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788988|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788989|NCT01443923|O2|Outcome|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788990|NCT01443923|O1|Outcome|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788991|NCT01443923|E2|Reported Event|2 HCV/HIV|"Hepatitis C and HIV co-Infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788992|NCT01443923|E1|Reported Event|1-HCV|"Hepatitis C Mono-infected~Boceprevir~Peg-Interferon-alfa 2B~Ribavirin"
788993|NCT01443858|B4|Baseline|Total|Total of all reporting groups
789040|NCT01443403|B3|Baseline|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789041|NCT01443403|B2|Baseline|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789042|NCT01443403|B1|Baseline|Placebo|Participants received placebo orally once daily for 28 days.
789043|NCT01443403|P4|Participant Flow|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789044|NCT01443403|P3|Participant Flow|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
788994|NCT01443858|B3|Baseline|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
788995|NCT01443858|B2|Baseline|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
788996|NCT01443858|B1|Baseline|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
788997|NCT01443858|P3|Participant Flow|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
788998|NCT01443858|P2|Participant Flow|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
788999|NCT01443858|P1|Participant Flow|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789000|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789001|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789002|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789045|NCT01443403|P2|Participant Flow|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789046|NCT01443403|P1|Participant Flow|Placebo|Participants received placebo orally once daily for 28 days.
789047|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789048|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
842827|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
789003|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789004|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789005|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789006|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789007|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789008|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789009|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789010|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789011|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789049|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789050|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789051|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789052|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789053|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789012|NCT01443858|O3|Outcome|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789013|NCT01443858|O2|Outcome|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789014|NCT01443858|O1|Outcome|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789015|NCT01443858|E3|Reported Event|50mg Meclizine|"Subjects in this group will take 50mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789016|NCT01443858|E2|Reported Event|25mg Meclizine|"Subjects in this group will take 25mg of meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Meclizine will be administered in two doses each day.~Meclizine: Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789017|NCT01443858|E1|Reported Event|Control|"Subjects in this group will take placebo meclizine daily for the three weeks prior to their quit date. Subjects will also apply a 21mg/24h nicotine patch daily starting in the second week of pre-quit treatment. Placebo meclizine will be administered in two doses each day.~Nicotine patches: Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
789018|NCT01443845|B3|Baseline|Total|Total of all reporting groups
789019|NCT01443845|B2|Baseline|Roflumilast|Roflumilast 500 µg, oral administration, once per day
789020|NCT01443845|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
789021|NCT01443845|P2|Participant Flow|Roflumilast|Roflumilast 500 µg, oral administration, once per day
789022|NCT01443845|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
789023|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
789024|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
789025|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
789026|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
789027|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
789028|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
789029|NCT01443845|O2|Outcome|Roflumilast|Roflumilast 500 µg, oral administration, once per day
789030|NCT01443845|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
789031|NCT01443845|E2|Reported Event|Roflumilast|Roflumilast 500 µg, oral administration, once per day
789032|NCT01443845|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
789033|NCT01443494|B1|Baseline|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
789034|NCT01443494|P1|Participant Flow|Septic Shock Patients Despite EGDT With Hypertension|Patients with previous hypertension requiring norepinephrine to maintain a MAP of 65 mm Hg despite fluid resuscitation to central venous pressure above 8 mm Hg.
789035|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
789036|NCT01443494|O1|Outcome|Septic Shock Patients Despite EGDT|After stabilization for 30 min, basal measurements including hemodynamic and microcirculatory measurements were taken, 20 min apart, the NE doses were increased to titrate MAP to the target level. Patients were allowed to stabilize for 30 min before taking new measurements.
789057|NCT01443403|O3|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789058|NCT01443403|O2|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789059|NCT01443403|O1|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789060|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789061|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789062|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789063|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789064|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789065|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789066|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789067|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789068|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789069|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789070|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789071|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789072|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789073|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789074|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789075|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789076|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789077|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789078|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789079|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789080|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789081|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789082|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789083|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789084|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789085|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789086|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789087|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789088|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789089|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789090|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789091|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789092|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789093|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789094|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789095|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789096|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789097|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789098|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789099|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789100|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789101|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789102|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789103|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789104|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789105|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789106|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789107|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789108|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789109|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789110|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789111|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789112|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789113|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789114|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789115|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789116|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789117|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789118|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789119|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789120|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789121|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789122|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789123|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789124|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789125|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789126|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789127|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789128|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789129|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789130|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789131|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789132|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789133|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789134|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789135|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789136|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789137|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789138|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789139|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789140|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789141|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789142|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789143|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789144|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789145|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789146|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789147|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789148|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789149|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789150|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789151|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789152|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789153|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789154|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789155|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789156|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789157|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789158|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789159|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789160|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789161|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789162|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789163|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789164|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789165|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789166|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789167|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789168|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789169|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789170|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789172|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789173|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789174|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789175|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789176|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789177|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789178|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789179|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789180|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789181|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789182|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789183|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789184|NCT01443403|O4|Outcome|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789185|NCT01443403|O3|Outcome|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789186|NCT01443403|O2|Outcome|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789187|NCT01443403|O1|Outcome|Placebo|Participants received placebo orally once daily for 28 days.
789188|NCT01443403|E4|Reported Event|Naldemedine 0.4 mg|Participants received 0.4 mg naldemedine orally once daily for 28 days.
789189|NCT01443403|E3|Reported Event|Naldemedine 0.2 mg|Participants received 0.2 mg naldemedine orally once daily for 28 days.
789190|NCT01443403|E2|Reported Event|Naldemedine 0.1 mg|Participants received 0.1 mg naldemedine orally once daily for 28 days.
789191|NCT01443403|E1|Reported Event|Placebo|Participants received placebo orally once daily for 28 days.
789192|NCT01443364|B1|Baseline|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789193|NCT01443364|P1|Participant Flow|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789194|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789195|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789196|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789197|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789198|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789199|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789200|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789201|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789202|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789203|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789396|NCT01442844|E2|Reported Event|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
789331|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789204|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789205|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789206|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789207|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789208|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789209|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789210|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789211|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789212|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789213|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789214|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789215|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789216|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789217|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789218|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789219|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789220|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789221|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789222|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789223|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789463|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789224|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789225|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789226|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789227|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789228|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789229|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789230|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789231|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789232|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789233|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789234|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789235|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789236|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789237|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789238|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789239|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789240|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789241|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789242|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789243|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789464|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
842828|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
789244|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789245|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789246|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789247|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789248|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789249|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789250|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789251|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789252|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789253|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789254|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789255|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789256|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789257|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789258|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789259|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789260|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789261|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789262|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789263|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789465|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789264|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789265|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789266|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789267|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789268|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789269|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789270|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789271|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789272|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789273|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789274|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789275|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789276|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789277|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789278|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789279|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789280|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789281|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789282|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789283|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789466|NCT01442181|E2|Reported Event|Medical Therapy|Patients are treated with rhythm and rate control medications.
842829|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
789284|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789285|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789286|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789287|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789288|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789289|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789290|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789291|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789292|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789293|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789294|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789295|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789296|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789297|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789298|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789299|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789300|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789301|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789302|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789303|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789467|NCT01442181|E1|Reported Event|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789304|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789305|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789306|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789307|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789308|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789309|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789310|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789311|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789312|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789313|NCT01443364|O1|Outcome|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789314|NCT01443364|E1|Reported Event|Certolizumab Pegol|Subjects will be treated for 52 weeks with Certolizumab Pegol (CZP) (administration every two weeks) in combination with Methotrexate (MTX) (administration weekly). Dosing regimen of CZP consists of 3 administrations of 400 mg at Weeks 0, 2 and 4 followed by 200 mg every other week up to and including Week 50.
789315|NCT01443130|B7|Baseline|Total|Total of all reporting groups
789316|NCT01443130|B6|Baseline|Infant SP IPT|Infants born to maternal participants who received SP IPT.
789317|NCT01443130|B5|Baseline|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
789318|NCT01443130|B4|Baseline|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
789319|NCT01443130|B3|Baseline|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789320|NCT01443130|B2|Baseline|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789321|NCT01443130|B1|Baseline|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789322|NCT01443130|P6|Participant Flow|Infant SP IPT|Infants born to maternal participants who received SP IPT.
789323|NCT01443130|P5|Participant Flow|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
789324|NCT01443130|P4|Participant Flow|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
789325|NCT01443130|P3|Participant Flow|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789326|NCT01443130|P2|Participant Flow|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789327|NCT01443130|P1|Participant Flow|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789328|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789329|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789330|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
842830|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
789332|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789333|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789334|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789335|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789336|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789337|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789338|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789339|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789340|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
789341|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
789342|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
789343|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
789344|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
789345|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
789346|NCT01443130|O3|Outcome|Infant SP IPT|Infants born to maternal participants who received SP IPT.
789347|NCT01443130|O2|Outcome|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
789348|NCT01443130|O1|Outcome|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
789349|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789350|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789351|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789352|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789353|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789354|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789355|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789356|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789357|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789358|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789359|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789360|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789361|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789362|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789363|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789364|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789365|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789366|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789367|NCT01443130|O3|Outcome|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789368|NCT01443130|O2|Outcome|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789369|NCT01443130|O1|Outcome|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789370|NCT01443130|E6|Reported Event|Infant SP IPT|Infants born to maternal participants who received SP IPT.
789371|NCT01443130|E5|Reported Event|Infant Chloroquine IPT|Infants born to maternal participants who received chloroquine IPT.
789372|NCT01443130|E4|Reported Event|Infant Chloroquine Prophylaxis|Infants born to maternal participants who received chloroquine prophylaxis.
789373|NCT01443130|E3|Reported Event|Maternal SP IPT|Maternal participants receive a therapeutic dose of sulfadoxine-pyrimethamine (SP), (1500 mg sulfadoxine and 75 mg pyrimethamine (3 tablets)) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789374|NCT01443130|E2|Reported Event|Maternal Chloroquine IPT|Maternal participants receive a therapeutic dose of chloroquine (1,500 mg given over 3 days, 2 tablets on Day 0, 2 tablets on Day 1, 1 tablet on Day 2) administered twice during pregnancy at 20-28 weeks and at 28-34 weeks.
789375|NCT01443130|E1|Reported Event|Maternal Chloroquine Prophylaxis|Maternal participants receive a loading dose of chloroquine (base) 600 mg (2 tablets) at first administration followed by 300 mg of chloroquine base (1 tablet) every week until delivery.
789376|NCT01443078|B1|Baseline|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
789377|NCT01443078|P1|Participant Flow|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
789378|NCT01443078|O1|Outcome|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
789379|NCT01443078|E1|Reported Event|All Patients|Patients with clinical Stage IB-III resectable and operable non-small cell lung cancer
789380|NCT01443026|B3|Baseline|Total|Total of all reporting groups
789381|NCT01443026|B2|Baseline|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
789382|NCT01443026|B1|Baseline|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
789383|NCT01443026|P2|Participant Flow|Placebo|"Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
789384|NCT01443026|P1|Participant Flow|Lycopene|"Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)~Lycopene 30 mg or Placebo: Taken until clinically-indicated repeat biopsy performed (approximately 6 months)"
789385|NCT01443026|O2|Outcome|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
789386|NCT01443026|O1|Outcome|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
789387|NCT01443026|E2|Reported Event|Placebo|Placebo taken until clinically-indicated repeat biopsy performed (approximately 6 months)
789388|NCT01443026|E1|Reported Event|Lycopene|Lycopene 30 mg/day until clinically-indicated repeat biopsy performed (approximately 6 months)
789389|NCT01442844|B3|Baseline|Total|Total of all reporting groups
789390|NCT01442844|B2|Baseline|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
789391|NCT01442844|B1|Baseline|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
789392|NCT01442844|P2|Participant Flow|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
789393|NCT01442844|P1|Participant Flow|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
789394|NCT01442844|O2|Outcome|No Intervention|No intervention will be performed. Subject will receive dressings that are standard of care.
789395|NCT01442844|O1|Outcome|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
789426|NCT01442376|B3|Baseline|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
789397|NCT01442844|E1|Reported Event|Micrografting|"Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.~Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound."
789398|NCT01442779|B1|Baseline|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
789399|NCT01442779|P1|Participant Flow|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
789400|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
789401|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
789402|NCT01442779|O1|Outcome|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
789403|NCT01442779|E1|Reported Event|Interferon Alpha|Treatment with low dose oral interferon alpha lozenges taken 3 times daily (approximately 6 hours apart). Lozenge is to be dissolved under tongue or by moving around in mouth.
789404|NCT01442688|B3|Baseline|Total|Total of all reporting groups
789405|NCT01442688|B2|Baseline|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
789406|NCT01442688|B1|Baseline|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
789407|NCT01442688|P2|Participant Flow|Amoxicillin + MMX Mesalazine/Mesalamine First|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for first intervention. Then, MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for second intervention.
789408|NCT01442688|P1|Participant Flow|Amoxicillin + MMX Placebo First|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4 for first intervention. Then, MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4 for second intervention.
789409|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
789410|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
789411|NCT01442688|O2|Outcome|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
789412|NCT01442688|O1|Outcome|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
789413|NCT01442688|E2|Reported Event|Amoxicillin + MMX Mesalazine/Mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
789414|NCT01442688|E1|Reported Event|Amoxicillin + MMX Placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
789415|NCT01442675|B1|Baseline|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
789416|NCT01442675|P1|Participant Flow|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine in this study.
789417|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
789418|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
789419|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
789420|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
789421|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
789422|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age ≥11 years received a single dose of Menactra vaccine
789423|NCT01442675|O1|Outcome|Menactra® Vaccine Group|Participants <56 years of age who received Menactra vaccine 4-6 years previously at age ≥11 years received a single dose of Menactra in this study.
789424|NCT01442675|E1|Reported Event|Menactra® Vaccine Group|Participants <56 years of age who received Menactra 4-6 years previously at age >= 11 years received a single dose of Menactra vaccine
789425|NCT01442376|B4|Baseline|Total|Total of all reporting groups
789575|NCT01441960|E2|Reported Event|NMBA: Rocuronium|No adverse events occurred during the study
842831|NCT01255592|O2|Outcome|Placebo|Placebo bd
789427|NCT01442376|B2|Baseline|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
789428|NCT01442376|B1|Baseline|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
789429|NCT01442376|P3|Participant Flow|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
789430|NCT01442376|P2|Participant Flow|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
789431|NCT01442376|P1|Participant Flow|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
789432|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
789433|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
789434|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
789435|NCT01442376|O3|Outcome|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
789436|NCT01442376|O2|Outcome|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
789437|NCT01442376|O1|Outcome|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
789438|NCT01442376|E3|Reported Event|Ondansetron|"Ondansetron and placebo to Palonosetron~Drug:~Comparator: Ondansetron~Ondansetron: Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg~Placebo to Palonosetron"
789439|NCT01442376|E2|Reported Event|Palonosetron 20 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg~Placebo to Ondansetron"
789440|NCT01442376|E1|Reported Event|Palonosetron 10 mcg/kg|"Palonosetron and placebo to Ondansetron~Intervention:~Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg~Placebo to Ondansetron"
789441|NCT01442181|B3|Baseline|Total|Total of all reporting groups
789442|NCT01442181|B2|Baseline|Medical Therapy|Patients are treated with rhythm and rate control medications.
789443|NCT01442181|B1|Baseline|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789444|NCT01442181|P2|Participant Flow|Medical Therapy|Patients are treated with rhythm and rate control medications.
789445|NCT01442181|P1|Participant Flow|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789446|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
789447|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789448|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
789449|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789450|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
789451|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789452|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications.
789453|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789454|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
789455|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789456|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
789457|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789458|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
789459|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789460|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
789461|NCT01442181|O1|Outcome|Minimally Invasive Surgery|Thumb sized incisions are made on each sides of the chest wall where instruments are placed in the chest to perform the surgery.
789462|NCT01442181|O2|Outcome|Medical Therapy|Patients are treated with rhythm and rate control medications
789576|NCT01441960|E1|Reported Event|NMBA: Succinylcholine|No adverse events occurred during the study
789579|NCT01441843|B1|Baseline|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
790799|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
789468|NCT01442155|B1|Baseline|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
789469|NCT01442155|P1|Participant Flow|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
789470|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
789471|NCT01442155|O1|Outcome|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
789472|NCT01442155|E1|Reported Event|Capecitabine + Oxaliplatin|"Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.~Capecitabine: Administered according to the Summary of Product Characteristics.~Oxaliplatin: Administered according to the Summary of Product Characteristics."
789473|NCT01442129|B3|Baseline|Total|Total of all reporting groups
789474|NCT01442129|B2|Baseline|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
789475|NCT01442129|B1|Baseline|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
789476|NCT01442129|P2|Participant Flow|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
789477|NCT01442129|P1|Participant Flow|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
789478|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
789479|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
789480|NCT01442129|O2|Outcome|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
789481|NCT01442129|O1|Outcome|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
789482|NCT01442129|E2|Reported Event|Control Solution|"Intramyocardial injections of 50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO~50% Alpha-MEM/42.5% ProFreeze NAO Freezing Medium/7.5% DMSO: Injection of control solution during the LVAD implantation."
789483|NCT01442129|E1|Reported Event|MPC Intramyocardial Injection|"Intramyocardial injections of 25 million MPCs~Mesenchymal Precursor Cell Injection: Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation"
789484|NCT01442103|B1|Baseline|Silver Gel, Chronic Wounds|Open, non-comparative, single-centre investigation exploring the clinical utility of a new silver gel for use on chronic wounds.
789485|NCT01442103|P1|Participant Flow|Silver Gel, Chronic Wounds|The patients will present with chronic wounds in need of initial treatment prior to initiating standard of care (i.e. wound bed with eschar or slough), in need of treatment after debridement or with presenting inflammation along with need for treatment.Only one wound will be chosen for treatment in the study and the area should not exceed 10x10 cm and not be deeper than 6 cm. Photos of the wound will be taken at each visit.
789486|NCT01442103|O1|Outcome|Device Common Dressing|Normlgel® Ag is an opaque, amorphous hyrdrogel containing a high (>80%) water content and water soluble polymer chains.
789487|NCT01442103|E1|Reported Event|Device Common Dressing|Normal Ag is an opaque, amorphous hydrogel containing a high watersoluble polymer chains and an antimicrobial silver compund
789488|NCT01442064|B7|Baseline|Total|Total of all reporting groups
789489|NCT01442064|B6|Baseline|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789490|NCT01442064|B5|Baseline|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789491|NCT01442064|B4|Baseline|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
789492|NCT01442064|B3|Baseline|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789577|NCT01441843|B3|Baseline|Total|Total of all reporting groups
789493|NCT01442064|B2|Baseline|Ranibizumab (0.3 mg BRAVO)|In this extension study participant received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789494|NCT01442064|B1|Baseline|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
789495|NCT01442064|P6|Participant Flow|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789496|NCT01442064|P5|Participant Flow|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789497|NCT01442064|P4|Participant Flow|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
789498|NCT01442064|P3|Participant Flow|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789499|NCT01442064|P2|Participant Flow|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789500|NCT01442064|P1|Participant Flow|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
789501|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
789502|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789503|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year)for 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
789504|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789505|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789506|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
789507|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
789508|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789509|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
789510|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
790983|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
789511|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789512|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
789513|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
789514|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789515|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
789516|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789517|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789518|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
789519|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
789520|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789521|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
789522|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789523|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789524|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
789525|NCT01442064|O6|Outcome|Ranibizumab (0.5 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibuzumab intravitreal injections in the 6 month treatment period of CRUISE.
789526|NCT01442064|O5|Outcome|Ranibizumab (0.3 mg CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of CRUISE.
789527|NCT01442064|O4|Outcome|Ranibizumab (Sham CRUISE)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received sham intravitreal injections in the 6 month treatment period of CRUISE and received ranibizumab in the 6 month observation period of CRUISE or in this extension study.
789528|NCT01442064|O3|Outcome|Ranibizumab (0.5 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789578|NCT01441843|B2|Baseline|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
789529|NCT01442064|O2|Outcome|Ranibizumab (0.3 mg BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection as-needed administered no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO.
789530|NCT01442064|O1|Outcome|Ranibizumab (Sham BRAVO)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO and received ranibizumab in the 6 month observation period of BRAVO or in this extension study.
789531|NCT01442064|E3|Reported Event|Ranibizumab (0.5 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.5 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
789532|NCT01442064|E2|Reported Event|Ranibizumab (0.3 mg)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received 0.3 mg Ranibizumab intravitreal injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE.
789533|NCT01442064|E1|Reported Event|Ranibizumab (Sham)|In this extension study participants received Ranibizumab 0.5 mg intravitreal injection administered as-needed no more frequently than every 30 days (no more than 12 injections per year) up to 24 months. Participants in this group received intravitreal sham injections in the 6 month treatment period of BRAVO or the 6 month treatment period of CRUISE and received Ranibizumab during the 6 month observation period of the initial study or this extension study.
789534|NCT01442038|B3|Baseline|Total|Total of all reporting groups
789535|NCT01442038|B2|Baseline|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
789536|NCT01442038|B1|Baseline|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
789537|NCT01442038|P2|Participant Flow|Placebo|Ranolazine placebo (1 tablet) for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
789538|NCT01442038|P1|Participant Flow|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
789539|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
789540|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
789541|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
789542|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
789543|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
789544|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
789545|NCT01442038|O2|Outcome|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
789546|NCT01442038|O1|Outcome|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
789547|NCT01442038|E2|Reported Event|Placebo|Ranolazine placebo (1 tablet) twice daily for 7 days, followed by ranolazine placebo (2 tablets) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine placebo (1 tablet) twice daily for the duration of the study)
789548|NCT01442038|E1|Reported Event|Ranolazine|Ranolazine 500 mg (1 x 500 mg tablet) twice daily for 7 days, followed by ranolazine 1000 mg (2 x 500 mg tablet) twice daily for the duration of the study (participants receiving a moderate CYP3A4 inhibitor continued to receive ranolazine 500 mg (1 x 500 mg tablet) twice daily for the duration of the study)
789549|NCT01441973|B3|Baseline|Total|Total of all reporting groups
789550|NCT01441973|B2|Baseline|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789670|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789551|NCT01441973|B1|Baseline|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789552|NCT01441973|P2|Participant Flow|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789553|NCT01441973|P1|Participant Flow|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789554|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789555|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789556|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789557|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789558|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789559|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789560|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789561|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789562|NCT01441973|O2|Outcome|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789563|NCT01441973|O1|Outcome|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789564|NCT01441973|E2|Reported Event|Elotuzumab, 10 mg/kg|Participants in the second group received elotuzumab intravenously at a dose of 10 mg/kg weekly per 28-day cycle in Cycles 1 and 2, then on Days 1 and 15 in subsequent cycles.
789565|NCT01441973|E1|Reported Event|Elotuzumab, 20 mg/kg|Participants in 2 arms were enrolled sequentially. The first group of participants received elotuzumab intravenously at a dose of 20 mg/kg on Days 1 and 8 per 28-day cycle for Cycle 1 and then on Day 1 only in subsequent cycles.
789566|NCT01441960|B1|Baseline|Succinylcholine and Rocuronium|All study participants
789567|NCT01441960|P2|Participant Flow|Rocuronium First , Then Succinylcholine|"After induction of anesthesia Rocuronium (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the rocuronium-induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg.~By identifying the optimal (minimal effective) dose of rocuronium, in the subsequent treatment of the subject, Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline."
789568|NCT01441960|P1|Participant Flow|Succinylcholine First, Then Rocuronium|"After induction of anesthesia Succinylcholine (Quelicin®, Hospira Inc., Lake Forest, IL) 0.8 (2.67 × ED95) mg/kg was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline.~By identifying the optimal (minimal effective) dose of succinylcholine, Rocuronium bromide (Zemuron®, Oganon USA Inc) 0.4 mg/kg (1.33 × ED95) was administered intravenously over 5 sec via an intravenous catheter in the arm contralateral to the side of neuromuscular transmission monitoring, which was then flushed with a 10 ml bolus of normal saline. After the ECT treatment and when appropriate, as determined by the practicing anesthesiologist, the induced neuromuscular blockade was reversed with neostigmine 50 microgram/kg, administered with glycopyrrolate 10 microgram/kg."
789569|NCT01441960|O2|Outcome|Rocuronium|Duration of induced seizure
789570|NCT01441960|O1|Outcome|Succinylcholine|Duration of induced seizure after standard ECT
789571|NCT01441960|O2|Outcome|Rocuronium|Time to recovery after single bolus administered at the beginning of ECT therapy
789572|NCT01441960|O1|Outcome|Succinylchline|Time to recovery after single bolus administered at the beginning of ECT therapy
789573|NCT01441960|O2|Outcome|NMBA- Rocuronium|Cross-over randomized controlled, assessor blinded clinical trial. Rocuronium: Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
789574|NCT01441960|O1|Outcome|NMBA: Sux|"Cross-over randomized controlled, assessor blinded clinical trial.~Succinylcholine: Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'."
842832|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
789580|NCT01441843|P2|Participant Flow|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
789581|NCT01441843|P1|Participant Flow|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
789582|NCT01441843|O2|Outcome|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
789583|NCT01441843|O1|Outcome|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
789584|NCT01441843|E2|Reported Event|NaCl 0.9%|"NaCl 0.9% 4ml~NaCl 0.9% (Sodium Chloride) : Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery"
789585|NCT01441843|E1|Reported Event|Lorazepam|"Lorazepam 4mg/4ml~Lorazepam : Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery"
789586|NCT01441765|B3|Baseline|Total|Total of all reporting groups
789587|NCT01441765|B2|Baseline|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789588|NCT01441765|B1|Baseline|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789589|NCT01441765|P2|Participant Flow|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789590|NCT01441765|P1|Participant Flow|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789591|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789592|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789593|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789594|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789595|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789596|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789597|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789598|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789599|NCT01441765|O2|Outcome|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789600|NCT01441765|O1|Outcome|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789601|NCT01441765|E2|Reported Event|CT-011 With DC/RCC Fusion Vaccine|"CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks~DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4"
789602|NCT01441765|E1|Reported Event|CT-011|"CT-011 3 mg/kg for 4 cycles of 6 weeks~CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks"
789603|NCT01441596|B4|Baseline|Total|Total of all reporting groups
789604|NCT01441596|B3|Baseline|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
789605|NCT01441596|B2|Baseline|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
789606|NCT01441596|B1|Baseline|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
789607|NCT01441596|P3|Participant Flow|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
789608|NCT01441596|P2|Participant Flow|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
789609|NCT01441596|P1|Participant Flow|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
789610|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
789611|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
789612|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
789613|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
789614|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
789615|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
789616|NCT01441596|O3|Outcome|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
789617|NCT01441596|O2|Outcome|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
789618|NCT01441596|O1|Outcome|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
789619|NCT01441596|E3|Reported Event|Investigator's Choice|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
789620|NCT01441596|E2|Reported Event|Afatinib+Vino|Afatinib 40 mg per day administered orally, continuous treatment, in combination with weekly Vinorelbine 25 mg/m² administered intravenously on days 1, 8, 15 in a 3-weekly course.
789621|NCT01441596|E1|Reported Event|Afatinib Mono|Afatinib monotherapy administered orally: starting dose 40 mg per day, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
789622|NCT01441570|B3|Baseline|Total|Total of all reporting groups
789623|NCT01441570|B2|Baseline|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
789624|NCT01441570|B1|Baseline|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
789625|NCT01441570|P2|Participant Flow|Metoprolol Succinate|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
789626|NCT01441570|P1|Participant Flow|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
789627|NCT01441570|O2|Outcome|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
789628|NCT01441570|O1|Outcome|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
789629|NCT01441570|O2|Outcome|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
789630|NCT01441570|O1|Outcome|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
789631|NCT01441570|E2|Reported Event|Metoprolol|Metoprolol succinate: Subject will take metoprolol succinate daily for 12 weeks.
789632|NCT01441570|E1|Reported Event|Nebivolol|Nebivolol: Subject will take nebivolol daily for 12 weeks.
789633|NCT01441466|B3|Baseline|Total|Total of all reporting groups
789634|NCT01441466|B2|Baseline|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789635|NCT01441466|B1|Baseline|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
789636|NCT01441466|P2|Participant Flow|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789637|NCT01441466|P1|Participant Flow|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
789638|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789639|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
789640|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789641|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
789642|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789643|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
789644|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789645|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
789646|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789647|NCT01441466|O1|Outcome|Group Without Isolation|"Patients in this arm are nursed together (in the same room) independent of viral agent.~Isolation: Patients in this arm are nursed together (in the same room) independent of viral agent"
789648|NCT01441466|O2|Outcome|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789649|NCT01441466|O1|Outcome|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
789650|NCT01441466|E2|Reported Event|Group With Isolation|Patients in this arm are nursed separately until the test result of the PCR (polymerase chain reaction) for viral agents is known (within 24-48 hrs). RS-positive patients are nursed separately (separate room) from RS-negative patients
789651|NCT01441466|E1|Reported Event|Group Without Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent.
789652|NCT01441440|B4|Baseline|Total|Total of all reporting groups
789653|NCT01441440|B3|Baseline|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789654|NCT01441440|B2|Baseline|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789655|NCT01441440|B1|Baseline|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789656|NCT01441440|P3|Participant Flow|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789657|NCT01441440|P2|Participant Flow|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789658|NCT01441440|P1|Participant Flow|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789659|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789660|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789661|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789662|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789663|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789664|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789665|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789666|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789667|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789668|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789669|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789758|NCT01441180|B2|Baseline|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
789671|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789672|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789673|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789674|NCT01441440|O3|Outcome|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789675|NCT01441440|O2|Outcome|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789676|NCT01441440|O1|Outcome|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789677|NCT01441440|E3|Reported Event|Venlafaxine 75-225 mg/Day Flexible|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was increased to 150 mg/day. If there was no tolerability concern at Week 3, the dose was increased to 225 mg/day. Dose was reduced in the case of intolerability and if the participants could not take venlafaxine 75 mg/day or higher doses at Week 1 and the following weeks, the treatment were discontinued. No dose adjustment was allowed from Week 4 to Week 8.
789678|NCT01441440|E2|Reported Event|Venlafaxine 75 mg/Day Fixed|Participants received venlafaxine ER capsule orally once daily after meal for 8 weeks. Starting dose was 37.5 mg/day followed by 75 mg/day at Week 1. If there was no tolerability concern at Week 2, the dose was continued 75 mg/day until Week 8.
789679|NCT01441440|E1|Reported Event|Placebo|Participants received placebo capsule orally once daily after meal for 8 weeks.
789680|NCT01441414|B1|Baseline|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789681|NCT01441414|P1|Participant Flow|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789682|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789683|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789684|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789685|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789686|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789687|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789688|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789689|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789690|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789691|NCT01441414|O1|Outcome|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789692|NCT01441414|O4|Outcome|All-causality CTCAE Grade 5|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 5 TEAEs are presented
789693|NCT01441414|O3|Outcome|All-causality CTCAE Grade 4|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 4 TEAEs are presented
789694|NCT01441414|O2|Outcome|All-causality CTCAE Grade 3|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 3 TEAEs are presented
789695|NCT01441414|O1|Outcome|All-causality CTCAE Grade 2|Number of participants who had serious TEAEs (all-causality) of CTCAE Grade 2 TEAEs are presented
789696|NCT01441414|O8|Outcome|Treatment-related Overall|Incidence and severity of treatment-related CTCAE Grades 3,4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789697|NCT01441414|O7|Outcome|All-causality Overall|Incidence and severity of all-causality CTCAE Grades 3, 4, and 5 are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789698|NCT01441414|O6|Outcome|Treatment-related CTCAE Grade 5|Incidence and severity of treatment-related CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789699|NCT01441414|O5|Outcome|Treatment-related CTCAE Grade 4|Incidence and severity of treatment-related CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789700|NCT01441414|O4|Outcome|Treatment-related CTCAE Grade 3|Incidence and severity of treatment-related CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789701|NCT01441414|O3|Outcome|All-causality CTCAE Grade 5|Incidence and severity of all-causality CTCAE Grade 5 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789702|NCT01441414|O2|Outcome|All-causality CTCAE Grade 4|Incidence and severity of all-causality CTCAE Grade 4 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789703|NCT01441414|O1|Outcome|All-causality CTCAE Grade 3|Incidence and severity of all-causality CTCAE Grade 3 TEAEs are presented. Participants with multiple occurrences of an AE within a category were counted once within the category.
789704|NCT01441414|E1|Reported Event|PF-04856884 + AG-013736|Participants in Part I received PF-04856884 15 mg/kg/week and AG-013736 5 mg twice a day. Following the decision of 06 November 2012 not to continue with Part II of the study, any participant remaining in Part I continued to receive PF-04856884 at a reduced dose of 10 mg/kg/week in combination with AG-013736 (5 mg twice a week) or AG-013736 alone (5 mg twice a week).
789705|NCT01441401|B1|Baseline|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789706|NCT01441401|P1|Participant Flow|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789707|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789751|NCT01441245|O1|Outcome|Lenght of Hospitalization in cIV|Prevalence of hospital stay > 10 days in continuous intravenous furosemide infusion.
789752|NCT01441245|O2|Outcome|Urine Output in iIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
789753|NCT01441245|O1|Outcome|Urine Output in cIV|Evaluation of urine output in Intermittent intravenous furosemide infusion group
789754|NCT01441245|E2|Reported Event|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
789755|NCT01441245|E1|Reported Event|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
789708|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789709|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789710|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789711|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789712|NCT01441401|O2|Outcome|Long Term|Participants who received gabapentin for 1 year or more
789713|NCT01441401|O1|Outcome|Non-Long Term|Participants who received gabapentin for less than 1 year
789714|NCT01441401|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
789715|NCT01441401|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
789716|NCT01441401|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
789717|NCT01441401|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
789718|NCT01441401|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
789719|NCT01441401|O3|Outcome|Unknown|Participants with unknown frequency of baseline epileptic seizure
789720|NCT01441401|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8
789721|NCT01441401|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure 8 or less
789722|NCT01441401|O4|Outcome|Unknown|Participants with unknown severity of baseline epileptic seizure
789723|NCT01441401|O3|Outcome|Severe|Participants with severe epileptic seizure at baseline
789724|NCT01441401|O2|Outcome|Moderate|Participants with moderate epileptic seizure at baseline
789725|NCT01441401|O1|Outcome|Mild|Participants with mild epileptic seizure at baseline
789726|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789727|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789756|NCT01441180|B4|Baseline|Total|Total of all reporting groups
789757|NCT01441180|B3|Baseline|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
789728|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789729|NCT01441401|O1|Outcome|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789730|NCT01441401|E1|Reported Event|Gabapentin Tablets/Syrup|For participants aged 13 years or older, 600 mg in 3 divided doses (div.) was administered on day 1 and an effective dose of 1200 mg in 3 div. was administered on day 2. From day 3 on, participants were maintained on 1200 mg to 1800 mg in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum daily dose of 2400 mg). For participants aged 3 to 12 years, 10 mg/kg/day was administered orally in 3 div. on day 1 of the treatment, and an effective dose of 20 mg/kg/day was administered in 3 div. on day 2. From day 3 on, participants aged 3 to 4 years were maintained on 40 mg/kg/day in 3 div. and participants aged 5 to 12 years were maintained on 25 to 35 mg/kg/day in 3 div. The maintenance dose was adjusted according to the symptoms (up to a maximum dose of 50 mg/kg/day). At any time point, the dose was not exceeded that for participants aged 13 years or older.
789731|NCT01441245|B3|Baseline|Total|Total of all reporting groups
789732|NCT01441245|B2|Baseline|iIV Group|The group that received the intermittent infusion of furosemide (iIV), consisted of 27 patients.
789733|NCT01441245|B1|Baseline|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
789734|NCT01441245|P2|Participant Flow|iIV Group|The second group that received the same drug in bolus injections twice a day (iIV), consisted of 27 patients.
789735|NCT01441245|P1|Participant Flow|cIV Group|The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients.
789736|NCT01441245|O2|Outcome|Dopamine Infusion in iIV|Prevalence of dopamine infusion in intermittent intravenous furosemide infusion.
789737|NCT01441245|O1|Outcome|Dopamine Infusion in cIV|Prevalence of dopamine infusion in continuous intravenous furosemide infusion.
789738|NCT01441245|O2|Outcome|GFR at Discharge in iIV|Mean GFR at discharge in intermittent intravenous fursoemide infusion.
789739|NCT01441245|O1|Outcome|GFR at Discharge in cIV|Mean GFR at discharge in continuous intravenous fursoemide infusion.
789740|NCT01441245|O2|Outcome|GFR Change in iIV|Mean GFR change in intermittent intravenous fursoemide infusion.
789741|NCT01441245|O1|Outcome|GFR Change in cIV|Mean GFR change in continuous intravenous fursoemide infusion.
789742|NCT01441245|O2|Outcome|BNP Change in iIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
789743|NCT01441245|O1|Outcome|BNP Change in cIV|Evaluation of BNP change in Intermittent intravenous furosemide infusion group
789744|NCT01441245|O2|Outcome|BNP Levels at Discharge in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
789745|NCT01441245|O1|Outcome|BNP Levels at Discharge in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
789746|NCT01441245|O2|Outcome|Changes in Creatinine in iIV Group|"The group that received the bolus infusion of furosemide (iIV), consisted of 27 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
789747|NCT01441245|O1|Outcome|Changes in Creatinine in cIV Group|"The group that received the continuous infusion of furosemide (cIV), consisted of 30 patients~furosemide infusion: Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours"
789748|NCT01441245|O2|Outcome|Creatinine at Discharge in iIV|Mean creatinine at discharge in intermittent intravenous fursoemide infusion.
789749|NCT01441245|O1|Outcome|Creatinine at Discharge in cIV|Mean creatinine at discharge in continuous intravenous fursoemide infusion.
789750|NCT01441245|O2|Outcome|Lenght of Hospitalization in iIV|Prevalence of hospital stay > 10 days in intermittent intravenous furosemide infusion.
789759|NCT01441180|B1|Baseline|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
789760|NCT01441180|P3|Participant Flow|Phase 2 Arm B|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
789761|NCT01441180|P2|Participant Flow|Phase 2 Arm A|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
789762|NCT01441180|P1|Participant Flow|Phase 1|(N =10): Participants will be enrolled and will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.
789763|NCT01441180|O3|Outcome|Phase 2 Arm B|"(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).~GS7977~RBV"
789764|NCT01441180|O2|Outcome|Phase 2 Arm A|"(N =25) 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)~GS7977~RBV"
789765|NCT01441180|O1|Outcome|Phase 1|"Participants (N =10) will receive GS-7977 QD in combination with RBV for a total of 24 weeks. The study team will perform an interim evaluation of data and safety at the end of 12 weeks of treatment.~GS7977~RBV"
789766|NCT01441180|O3|Outcome|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
789767|NCT01441180|O2|Outcome|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
789768|NCT01441180|O1|Outcome|Phase 1|
789769|NCT01441180|E3|Reported Event|Phase 2 Arm B (Sofosbuvir + Low-dose RBV)|(N = 25): 24 weeks of GS-7977 QD with low dose RBV (600mg).
789770|NCT01441180|E2|Reported Event|Phase 2 Arm A (Sofosbuvir + Weight Based RBV)|(N =25): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
789771|NCT01441180|E1|Reported Event|Phase 1 (Sofosbuvir + Weight Based RBV)|(N =10): 24 weeks of GS-7977 QD in combination with weight based RBV (1000 mg for participants weighing <75 kg and 1200 mg for participants weighing ≥75kg)
789772|NCT01441102|B1|Baseline|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789773|NCT01441102|P1|Participant Flow|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789774|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789775|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789776|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789777|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789778|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789779|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789780|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789781|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789782|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789783|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789784|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789785|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789786|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789787|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789788|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789789|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789790|NCT01441102|O1|Outcome|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789791|NCT01441102|E1|Reported Event|Dextromethorphan Hydrobromide|Dextromethorphan hydrobromide: Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
789792|NCT01441076|B1|Baseline|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789793|NCT01441076|P1|Participant Flow|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
792012|NCT01433263|E5|Reported Event|Follow-up - 30mg/kg BYM338 Late|Follow-up - 30mg/kg BYM338 Late
789794|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789795|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789796|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789797|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789798|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789799|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789800|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789801|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789802|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789803|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789804|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789805|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789806|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789807|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789808|NCT01441076|O1|Outcome|Anakinra|Treatment with Anakinra 100mg subcutaneous daily with option to escalate dose up to 300mg subcutaneous daily
789809|NCT01441076|E1|Reported Event|Anakinra|Treatment with Anakinra 100mg subcutaneous daily
789810|NCT01440972|B3|Baseline|Total|Total of all reporting groups
789811|NCT01440972|B2|Baseline|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789812|NCT01440972|B1|Baseline|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789813|NCT01440972|P2|Participant Flow|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789814|NCT01440972|P1|Participant Flow|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789815|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789816|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789817|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789818|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789819|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789820|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789821|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789822|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789823|NCT01440972|O2|Outcome|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789824|NCT01440972|O1|Outcome|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789825|NCT01440972|E2|Reported Event|Exercise With PBFR|partial blood flow restriction (PBFR): low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
789826|NCT01440972|E1|Reported Event|Exercise Without PBFR|low intensity resistance training: low intensity resistance training without partial blood flow restriction
789827|NCT01440959|B1|Baseline|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789828|NCT01440959|P1|Participant Flow|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789829|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789830|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789831|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789832|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789833|NCT01440959|O1|Outcome|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789834|NCT01440959|E1|Reported Event|TKI258|dovitinib : TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
789835|NCT01440946|B3|Baseline|Total|Total of all reporting groups
789836|NCT01440946|B2|Baseline|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
792013|NCT01433263|E4|Reported Event|Follow-up - Placebo|Follow-up - Placebo
789944|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789837|NCT01440946|B1|Baseline|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789838|NCT01440946|P2|Participant Flow|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789839|NCT01440946|P1|Participant Flow|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single intravenous (IV) injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last pharmacokinetic (PK) sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789840|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789841|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789842|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789843|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789844|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789845|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789846|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789847|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789848|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789849|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789884|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
789885|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
792014|NCT01433263|E3|Reported Event|Follow-up - 30mg/kg BYM338|Follow-up - 30mg/kg BYM338
789850|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789851|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789852|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789853|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789854|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789855|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789856|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789857|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789858|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789859|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789860|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789861|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789862|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789886|NCT01440881|O2|Outcome|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
789887|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
789888|NCT01440881|E2|Reported Event|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
789863|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789864|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789865|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789866|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789867|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789868|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789869|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789870|NCT01440946|O3|Outcome|Total|All Participants
789871|NCT01440946|O2|Outcome|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789872|NCT01440946|O1|Outcome|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789873|NCT01440946|E2|Reported Event|Participants 6 to < 12 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789874|NCT01440946|E1|Reported Event|Participants < 6 Years Old|"At Baseline and at Day 1, participants received a single IV injection of prestudy FIX and rFIXFc, respectively, over 10 (±5) minutes at a dose of 50 IU/kg. Immediately after the last PK sampling, the first prophylactic dose of approximately 50 to 60 IU/kg was administered in clinic as an IV injection.~Dose could be increased or decreased in increments of 10 IU/kg; increases to a maximum of 100 IU/kg and frequency of administration to a maximum of twice weekly, were allowed as indicated."
789875|NCT01440881|B3|Baseline|Total|Total of all reporting groups
789876|NCT01440881|B2|Baseline|Placebo|"infuses at 0.01MCG/KG/min for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
789877|NCT01440881|B1|Baseline|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
789878|NCT01440881|P2|Participant Flow|Placebo|"infuses at 0.01micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Placebo: infuses at 0.01MCG/KG/min for 48 hours"
789879|NCT01440881|P1|Participant Flow|Nesiritide|"infuses at 0.01 micrograms (MCG)/kilograms (KG)/minute (min) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
789880|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
789881|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
789882|NCT01440881|O2|Outcome|Placebo|infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours Placebo: infuses at 0.01MCG/KG/min for 48 hours
789883|NCT01440881|O1|Outcome|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
789889|NCT01440881|E1|Reported Event|Nesiritide|"infuses at 0.01 MCG (micrograms)/KG (kilograms)/min (minute) for 48 hours~Nesiritide: infuses at 0.01MCG/KG/min for 48 hours"
789890|NCT01440764|B3|Baseline|Total|Total of all reporting groups
789891|NCT01440764|B2|Baseline|F(80) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (80mg/8ml solution of Saline) and two Aerosol Saline (8ml) Interventions in any sequence or receive the Aerosol Furosemide (80mg/8ml solution of Saline), Aerosol Saline (8ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
789892|NCT01440764|B1|Baseline|F(40) Participants|Participants who consented to participate in the study and receive the Aerosol Furosemide (40mg/4ml solution of Saline), Aerosol Saline (4ml), and IV Furosemide (15mg/8ml Saline) Interventions in any sequence.
789893|NCT01440764|P7|Participant Flow|Saline, Then Saline, Then F(80)|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes."
789894|NCT01440764|P6|Participant Flow|Saline, Then F(80), Then Saline|"On Test Day 1, participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
789895|NCT01440764|P5|Participant Flow|F(80), Then Saline, Then Saline|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes."
789896|NCT01440764|P4|Participant Flow|Saline, Then F(80), Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 8ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
789897|NCT01440764|P3|Participant Flow|Saline, Then F(40), Then IV.F|"On Test Day 1, participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
789898|NCT01440764|P2|Participant Flow|IV.F, Then F(40), Then Saline|"On Test Day 1, participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes."
789899|NCT01440764|P1|Participant Flow|F(40), Then Saline, Then IV.F|"On Test Day 1, participants received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes.~On Test Day 2 (at least 24 hours after Test Day 1), participants received Aerosol Saline 4ml by inhalation for 5-10 minutes.~On Test Day 3 (at least 24 hours after Test Day 2), participants received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes."
789900|NCT01440764|O5|Outcome|IV Furosemide|"Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.~To be compared to Aerosol Furosemide (40mg) Arm and Aerosol Saline (4 ml) Arm.~Furosemide"
789901|NCT01440764|O4|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.~To be compared to Aerosol Furosemide (80mg) Arm.~Saline"
789902|NCT01440764|O3|Outcome|Aerosol Saline (4 ml)|"Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Furosemide (40mg) Arm and IV Furosemide Arm.~Saline"
789903|NCT01440764|O2|Outcome|Aerosol Furosemide (80mg)|"Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Saline (8ml) Arm.~Furosemide"
789904|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.~To be compared to Aerosol Saline (4ml) Arm and IV Furosemide Arm.~Furosemide"
789905|NCT01440764|O2|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject's data did not pass a priori requirements for quality control and the subject's data was excluded. Therefore, this analysis includes only the 11 subjects who met quality control."
789906|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Participants who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject had used cannabis recently and their information was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
789907|NCT01440764|O5|Outcome|Aerosol Saline (8 ml)|"Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days and met quality control.~12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
789908|NCT01440764|O4|Outcome|Aerosol Furosemide (80mg)|"Participants who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day and met quality control.~12 participants who consented to receive this intervention received the intervention and completed the study day. However, 1 subject's physiological data did not meet quality control and was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
789942|NCT01440595|P1|Participant Flow|Grazoprevir 200 mg + Peg-IFN + RBV|Grazoprevir 200 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789943|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789909|NCT01440764|O3|Outcome|IV Furosemide|"Participants who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day and met quality control.~Of the 13 participants who consented to receive this intervention, only 12 participants received the intervention and completed the study day (one withdrew before starting this intervention).~Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded. Also, 1 subject's data did not meet quality control and was excluded.~Therefore, this analysis includes only the 10 subjects who met quality control."
789910|NCT01440764|O2|Outcome|Aerosol Saline (4 ml)|"Participants who received Aerosol Saline (4ml) by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, only 11 participants received the intervention and completed the study day (one withdrew before starting this intervention).~Additionally, it was later discovered that 1 subject had used cannabis recently and their data was discarded.~Therefore, this analysis includes only the 10 subjects who met quality control."
789911|NCT01440764|O1|Outcome|Aerosol Furosemide (40 mg)|"Participants who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on a single test day and met quality control.~Of the 12 participants who consented to receive this intervention, all 12 participants received the intervention and completed the study day. However, it was later discovered that 1 subject had used cannabis recently and their information was discarded. Therefore, this analysis includes only the 11 subjects who met quality control."
789912|NCT01440764|E5|Reported Event|IV Furosemide|Any subject who received Furosemide 15 mg diluted in 10 ml of saline by intravenous delivery for 5 minutes on 1 test day.
789913|NCT01440764|E4|Reported Event|Aerosol Saline (8 ml)|Any subject who received Aerosol Saline 8ml by inhalation for 5-10 minutes on 2 test days.
789914|NCT01440764|E3|Reported Event|Aerosol Saline (4 ml)|Any subject who received Aerosol Saline 4ml by inhalation for 5-10 minutes on 1 test day.
789915|NCT01440764|E2|Reported Event|Aerosol Furosemide (80mg)|Any subject who received Aerosol Furosemide 80mg in 8ml saline by inhalation for 5-10 minutes on 1 test day.
789916|NCT01440764|E1|Reported Event|Aerosol Furosemide (40 mg)|Any subject who received Aerosol Furosemide 40mg in 4ml saline by inhalation for 5-10 minutes on 1 test day.
789917|NCT01440647|B3|Baseline|Total|Total of all reporting groups
789918|NCT01440647|B2|Baseline|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
789919|NCT01440647|B1|Baseline|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
789920|NCT01440647|P2|Participant Flow|CPAP|After extubation this arm was placed on CPAP (continuous positive airway pressure)and was not offered NIPPV in the first month on life
789921|NCT01440647|P1|Participant Flow|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
789922|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
789923|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
789924|NCT01440647|O2|Outcome|CPAP|Extubation to CPAP at the discretion of the medical team after extubation criteria were reached
789925|NCT01440647|O1|Outcome|NIPPV|Extubation to NIPPV when reaching extubation criteria
789926|NCT01440647|E2|Reported Event|CPAP|After extubation this arm was placed on CPAP and was not offered NIPPV in the first month on life
789927|NCT01440647|E1|Reported Event|NIPPV|Extubation to NIPPV (nasal intermittent positive pressure ventilation)
789928|NCT01440634|B3|Baseline|Total|Total of all reporting groups
789929|NCT01440634|B2|Baseline|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
789930|NCT01440634|B1|Baseline|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
789931|NCT01440634|P2|Participant Flow|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
789932|NCT01440634|P1|Participant Flow|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
789933|NCT01440634|O2|Outcome|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
789934|NCT01440634|O1|Outcome|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
789935|NCT01440634|E2|Reported Event|Standard of Care|Patients will be observed during the time of the study, no intervention will be applied. Patients are allowed to do their regular activity at home.
789936|NCT01440634|E1|Reported Event|Supervised Exercise|It consists of six months of supervised, intermittent track walking to near maximal leg pain or discomfort three days per week. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month.
789937|NCT01440595|B3|Baseline|Total|Total of all reporting groups
789938|NCT01440595|B2|Baseline|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789939|NCT01440595|B1|Baseline|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789940|NCT01440595|P3|Participant Flow|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789941|NCT01440595|P2|Participant Flow|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789945|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789946|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789947|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789948|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789949|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789950|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789951|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789952|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789953|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789954|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789955|NCT01440595|O2|Outcome|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789956|NCT01440595|O1|Outcome|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789957|NCT01440595|E2|Reported Event|Placebo + Peg-IFN + RBV|Placebo to grazoprevir once daily by mouth in combination with Peg-IFN and RBV for 12 weeks, followed by open-label Peg-IFN and RBV for an additional 12 weeks.
789958|NCT01440595|E1|Reported Event|Grazoprevir 400 mg + Peg-IFN + RBV|Grazoprevir 400 mg once daily by mouth in combination with Peg-IFN and RBV for 12 weeks.
789959|NCT01440569|B3|Baseline|Total|Total of all reporting groups
789960|NCT01440569|B2|Baseline|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789961|NCT01440569|B1|Baseline|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789962|NCT01440569|P2|Participant Flow|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789963|NCT01440569|P1|Participant Flow|Treatment-Naive|Treatment-naive participants received darunavir (DRV; 800 mg; 2 × 400 mg tablets) + cobicistat (COBI; 1 × 150 mg tablet) once daily + two nucleoside analogue reverse transcriptase inhibitors (NRTIs; per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789964|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789965|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789966|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789967|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789968|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789969|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789970|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789971|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789972|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789973|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
790074|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790080|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
789974|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789975|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789976|NCT01440569|O2|Outcome|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789977|NCT01440569|O1|Outcome|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789978|NCT01440569|E2|Reported Event|Treatment-Experienced|Treatment-experienced participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789979|NCT01440569|E1|Reported Event|Treatment-Naive|Treatment-naive participants received DRV (800 mg; 2 × 400 mg tablets) + COBI (1 × 150 mg tablet) once daily + two NRTIs (per prescribing information) for 48 weeks, and may have continued their regimen in the open-label rollover phase.
789980|NCT01440543|B5|Baseline|Total|Total of all reporting groups
789981|NCT01440543|B4|Baseline|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
789982|NCT01440543|B3|Baseline|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
789983|NCT01440543|B2|Baseline|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
789984|NCT01440543|B1|Baseline|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
789985|NCT01440543|P4|Participant Flow|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
789986|NCT01440543|P3|Participant Flow|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
789987|NCT01440543|P2|Participant Flow|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
789988|NCT01440543|P1|Participant Flow|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
789989|NCT01440543|O4|Outcome|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
789990|NCT01440543|O3|Outcome|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
789991|NCT01440543|O2|Outcome|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
789992|NCT01440543|O1|Outcome|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
789993|NCT01440543|E4|Reported Event|Air/Air|room air insufflation during both colonoscope insertion and withdrawal
789994|NCT01440543|E3|Reported Event|Water/CO2|water immersion during colonoscope insertion and CO2 insufflation during colonoscope withdrawal
789995|NCT01440543|E2|Reported Event|CO2/CO2|CO2 insufflation during both colonoscope insertion and withdrawal
789996|NCT01440543|E1|Reported Event|Water/Air|Water immersion during colonoscope insertion and air insufflation during colonoscope withdrawal
789997|NCT01440517|B1|Baseline|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
789998|NCT01440517|P1|Participant Flow|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
789999|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
790000|NCT01440517|O1|Outcome|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
790001|NCT01440517|E1|Reported Event|Tc99m-Maraciclatide Injection|The nominal activity of a single administration of Tc88m maraciclatide was 925 megabecquerels (MBq) (25 millicures).
790002|NCT01440387|B3|Baseline|Total|Total of all reporting groups
790003|NCT01440387|B2|Baseline|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790004|NCT01440387|B1|Baseline|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790005|NCT01440387|P2|Participant Flow|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790006|NCT01440387|P1|Participant Flow|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790007|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790008|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790009|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790010|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790011|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790012|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790013|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790014|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790015|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790016|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790017|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790018|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790019|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790020|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790021|NCT01440387|O2|Outcome|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790022|NCT01440387|O1|Outcome|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790023|NCT01440387|E2|Reported Event|FLULAVAL QUADRIVALENT Elderly Group|Subjects above 60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790024|NCT01440387|E1|Reported Event|FLULAVAL QUADRIVALENT Adult Group|Subjects 18-60 years of age received 1 dose of FLULAVAL® QUADRIVALENT vaccine at Day 0. The vaccine was administered intramuscularly in the deltoid of the non-dominant arm.
790025|NCT01440374|B4|Baseline|Total|Total of all reporting groups
790026|NCT01440374|B3|Baseline|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790027|NCT01440374|B2|Baseline|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790028|NCT01440374|B1|Baseline|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
790029|NCT01440374|P4|Participant Flow|Part 3: Eltrombopag|"23 subjects of the 47 randomized to the placebo group in Part 2 entered part 3. 36 subjects of the 98 randomized to the Etrombopag group in Part 2 entered part 3.~All subjects received eltrombopag. Part 3 subjects could also have received treatment for their disease per local SOC, including azacitidine, decitabine, lenalidomide, and chemotherapy. The duration of Part 3 was to be 10 months for subjects from Part 1and 9 months for subjects from Part 2."
790030|NCT01440374|P3|Participant Flow|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790031|NCT01440374|P2|Participant Flow|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790032|NCT01440374|P1|Participant Flow|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 milligrams (mg) daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
790033|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790075|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790076|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790034|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790035|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790036|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790037|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790038|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790039|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790040|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790041|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790042|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790043|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790044|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790045|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790046|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790047|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790048|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790049|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790077|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790078|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790079|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790050|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790051|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790052|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790053|NCT01440374|O2|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790054|NCT01440374|O1|Outcome|Part 2: Eltrombopag|Part 2: Eltrombopag The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790055|NCT01440374|O1|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
790056|NCT01440374|O1|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
790057|NCT01440374|O2|Outcome|Part 2: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The duration of treatment with the initial dose level prior to first dose escalation was determined based on the platelet response and toxicity observed in Part 1. The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. Supportive standard of care was allowed as needed throughout the study.
790058|NCT01440374|O1|Outcome|Part 2: Placebo|Participants received eltrombopag matching placebo once daily (3 tablets). Supportive standard of care was allowed as needed throughout the study.
790059|NCT01440374|O1|Outcome|Part 1: Eltrombopag|The eltrombopag starting dose the participants received was 100 mg daily (50 mg for participants of East Asian heritage). The dose of eltrombopag was escalated from 100 mg to 200 mg (50 mg to 100 mg for East Asians) and further from 200 mg to 300 mg once daily (100 mg to 150 mg for East Asians) based on the platelet response and safety data after two weeks of current dose level. After all participants finished the 8 week treatment period, platelet response and safety were analyzed before initiating Part 2 of the study. Supportive standard of care was allowed as needed. The duration of Part 1 was 8 weeks.
790060|NCT01440374|E4|Reported Event|Eltrombopag, Part 3 Plus 30 Days From Part 2 Subjects|Eltrombopag, Part 3 plus 30 Days from Part 2 subjects
790061|NCT01440374|E3|Reported Event|Placebo, Part 2 Plus 1 Day From Part 2 Subjects|Placebo, Part 2 plus 1 day from Part 2 subjects
790062|NCT01440374|E2|Reported Event|Eltrombopag, Part 2 Plus 1 Day From Part 2 Subjects|Eltrombopag, Part 2 plus 1 day from Part 2 subjects
790063|NCT01440374|E1|Reported Event|Eltrombopag, Part 1 Subjects|Eltrombopag, Part 1 subjects
790064|NCT01440322|B3|Baseline|Total|Total of all reporting groups
790065|NCT01440322|B2|Baseline|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790066|NCT01440322|B1|Baseline|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790067|NCT01440322|P2|Participant Flow|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790068|NCT01440322|P1|Participant Flow|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790069|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790070|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790071|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790072|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790073|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
792015|NCT01433263|E2|Reported Event|Core - Placebo|Core - Placebo
790081|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790082|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790083|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790084|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790085|NCT01440322|O2|Outcome|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790086|NCT01440322|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790087|NCT01440322|E2|Reported Event|AIR OPTIX® AQUA|Lotrafilcon B contact lenses worn in both eyes on a daily wear, monthly replacement basis for 3 months
790088|NCT01440322|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B contact lenses with color worn in both eyes on a daily wear, monthly replacement basis for 3 months
790089|NCT01440283|B1|Baseline|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
790090|NCT01440283|P1|Participant Flow|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
790091|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
790092|NCT01440283|O6|Outcome|Left Kidney: S-I|Nine participants who underwent all 3 scans.
790093|NCT01440283|O5|Outcome|Left Kidney: A-P|Nine participants who underwent all 3 scans.
790094|NCT01440283|O4|Outcome|Left Kidney: M-L|Nine participants who underwent all 3 scans.
790095|NCT01440283|O3|Outcome|Right Kidney: S-I|Nine participants who underwent all 3 scans.
790096|NCT01440283|O2|Outcome|Right Kidney: A-P|Nine participants who underwent all 3 scans.
790097|NCT01440283|O1|Outcome|Right Kidney: M-L|Nine participants who underwent all 3 scans.
790098|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
790099|NCT01440283|O1|Outcome|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
790100|NCT01440283|E1|Reported Event|Treatment|"Patients with high-risk abdominal neuroblastoma who receive any high-risk neuroblastoma treatment regimen were eligible to enroll prior to surgical resection of the primary tumor. Following implantation of fiducial markers within the tumor bed and autologous hematopoietic rescue, patients began the planning process for abdominal irradiation.~Intensity Modulated Radiation Therapy (IMRT) delivery followed current conventional volume-targeting guidelines, however, appropriate application within the abdomen was determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease was required."
790101|NCT01440101|B4|Baseline|Total|Total of all reporting groups
790102|NCT01440101|B3|Baseline|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790103|NCT01440101|B2|Baseline|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790104|NCT01440101|B1|Baseline|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
792016|NCT01433263|E1|Reported Event|Core - 30mg/kg BYM338|Core - 30mg/kg BYM338
790105|NCT01440101|P3|Participant Flow|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790106|NCT01440101|P2|Participant Flow|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790107|NCT01440101|P1|Participant Flow|Open Label Natalizumab|300 mg intravenous (IV) infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790108|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790109|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790110|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790111|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790112|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790113|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790114|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790115|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790116|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790117|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790118|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790119|NCT01440101|O1|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790120|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790121|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790122|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790123|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790124|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790125|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790126|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790127|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790128|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790129|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790130|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790131|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790132|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790133|NCT01440101|O2|Outcome|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790134|NCT01440101|O1|Outcome|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790135|NCT01440101|O1|Outcome|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790136|NCT01440101|E3|Reported Event|Double-Blind Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790137|NCT01440101|E2|Reported Event|Double-Blind Placebo|IV infusions of placebo over 60 minutes every 4 weeks for 20 weeks
790138|NCT01440101|E1|Reported Event|Open Label Natalizumab|300 mg IV infusions of natalizumab (BG00002) over 60 minutes every 4 weeks for 20 weeks
790139|NCT01440049|B1|Baseline|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790140|NCT01440049|P1|Participant Flow|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790141|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790142|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790143|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790144|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790145|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790210|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790146|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790147|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790148|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790149|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790150|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790151|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790152|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790153|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790154|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790155|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790156|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790157|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790158|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790159|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790160|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790161|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790162|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790163|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790164|NCT01440049|O1|Outcome|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790165|NCT01440049|E1|Reported Event|Eplerenone|Participants who received eplerenone according to the approved summary of product characteristics (SmPC) were observed for 12 months. Eplerenone treatment initiated at 25 mg once daily and titrated to the target dose of 50 mg once daily within 4 weeks based on the kalaemia level.
790166|NCT01439971|B6|Baseline|Total|Total of all reporting groups
790167|NCT01439971|B5|Baseline|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790168|NCT01439971|B4|Baseline|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790169|NCT01439971|B3|Baseline|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790170|NCT01439971|B2|Baseline|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790209|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790171|NCT01439971|B1|Baseline|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790172|NCT01439971|P5|Participant Flow|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790173|NCT01439971|P4|Participant Flow|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790174|NCT01439971|P3|Participant Flow|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790175|NCT01439971|P2|Participant Flow|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790176|NCT01439971|P1|Participant Flow|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790177|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790178|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790179|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790180|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790181|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790182|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790183|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790184|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790185|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790186|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790187|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790188|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790189|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790190|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790191|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790192|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790193|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790194|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790195|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790196|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790197|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790198|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790199|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790200|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790201|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790202|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790203|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790204|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790205|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790206|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790207|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790208|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790211|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790212|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790213|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790214|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790215|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790216|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790217|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790218|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790219|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790220|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790221|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790222|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790223|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790224|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790225|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790226|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790227|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790228|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790229|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790230|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790231|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790232|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790233|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790234|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790235|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790236|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790237|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790238|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790239|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790240|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790241|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790242|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790243|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790244|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790245|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790246|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790247|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
792017|NCT01433250|B3|Baseline|Total|Total of all reporting groups
790248|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790249|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790250|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790251|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790252|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790253|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790254|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790255|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790256|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790257|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790258|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790259|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790260|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790261|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790262|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790263|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790264|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790265|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790266|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790267|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790268|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790269|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790270|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790271|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790272|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790273|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790274|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790275|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790276|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790277|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790278|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790279|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790280|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790281|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790282|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790283|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790284|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790285|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790324|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790325|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790286|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790287|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790288|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790289|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790290|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790291|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790292|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790293|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790294|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790295|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790296|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790297|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790298|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790299|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790300|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790301|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790302|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790303|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790304|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790305|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790306|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790307|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790308|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790309|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790310|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790311|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790312|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790313|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790314|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790315|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790316|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790317|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790318|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790319|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790320|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790321|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790322|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790323|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
842833|NCT01255592|E2|Reported Event|Placebo|Placebo for AZD5069 bd
790326|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790327|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790328|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790329|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790330|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790331|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790332|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790333|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790334|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790335|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790336|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790337|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790338|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790339|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790340|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790341|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790342|NCT01439971|O5|Outcome|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790343|NCT01439971|O4|Outcome|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790344|NCT01439971|O3|Outcome|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790345|NCT01439971|O2|Outcome|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790346|NCT01439971|O1|Outcome|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790347|NCT01439971|E5|Reported Event|PF-05280602 30.0 mcg/kg|PF-05280602 30.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790348|NCT01439971|E4|Reported Event|PF-05280602 18.0 mcg/kg|PF-05280602 18.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790349|NCT01439971|E3|Reported Event|PF-05280602 9.0 mcg/kg|PF-05280602 9.0 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790350|NCT01439971|E2|Reported Event|PF-05280602 4.5 mcg/kg|PF-05280602 4.5 mcg/kg was administered as a single dose of bolus intravenous infusion on Day 1.
790351|NCT01439971|E1|Reported Event|PF-05280602 0.5 mcg/kg|PF-05280602 0.5 mcg/kg, the original lowest dosing arm, was administered as a single dose of bolus intravenous infusion on Day 1. The protocol was amended after a single participant was enrolled and the starting dose was changed to 4.5 mcg/kg.
790352|NCT01439945|B4|Baseline|Total|Total of all reporting groups
790353|NCT01439945|B3|Baseline|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790354|NCT01439945|B2|Baseline|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790355|NCT01439945|B1|Baseline|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790356|NCT01439945|P4|Participant Flow|High Dose Placebo|"Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take three placebo tablets daily (QD)."
790357|NCT01439945|P3|Participant Flow|Low Dose Placebo|"Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two placebo tablets daily (QD)."
790358|NCT01439945|P2|Participant Flow|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790423|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790578|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790359|NCT01439945|P1|Participant Flow|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790360|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790361|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790362|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790363|NCT01439945|O2|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790364|NCT01439945|O1|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790365|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790366|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790367|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790368|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790369|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790370|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790371|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790372|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790373|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790374|NCT01439945|O3|Outcome|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790375|NCT01439945|O2|Outcome|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790376|NCT01439945|O1|Outcome|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790377|NCT01439945|E4|Reported Event|Optional Continuation Phase|After the double blind phase patient questionnaire booklet has been completed and returned to the investigator, the patient will be told whether she was on magnesium or placebo. If the patient wishes to continue or start the magnesium, and healthcare provider approves that this is an appropriate option, she may be registered on the Optional Continuation Phase of the study. This phase will last up to 4 weeks of treatment following either 800 or 1200 mg/day treatment group.
790378|NCT01439945|E3|Reported Event|Placebo|"Patients registered to the High Dose Placebo and Low Dose Placebo are combined for treatment analysis.~Week 2:~Patients take one placebo tablets orally (PO) daily (QD).~Week 3:~Patients take two placebo tablets daily (QD).~Weeks 4-9:~Patients take two or three placebo tablets daily (QD)."
790379|NCT01439945|E2|Reported Event|High Dose Magnesium Oxide (1200 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take three 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790380|NCT01439945|E1|Reported Event|Low Dose Magnesium Oxide (800 mg/Day)|"Week 2:~Patients take one 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Week 3:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD).~Weeks 4-9:~Patients take two 400 mg tablet of magnesium oxide orally (PO) daily (QD)."
790381|NCT01439724|B3|Baseline|Total|Total of all reporting groups
790382|NCT01439724|B2|Baseline|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
790383|NCT01439724|B1|Baseline|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
790384|NCT01439724|P2|Participant Flow|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100mW, 4 Joules(J)/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
790385|NCT01439724|P1|Participant Flow|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
790386|NCT01439724|O2|Outcome|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
790387|NCT01439724|O1|Outcome|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
790388|NCT01439724|E2|Reported Event|Low Level Laser Therapy|"The investigators used a diode laser (DMC, São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.~Low Level Laser Therapy- (DMC, São Paulo, Brazil): Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region."
790389|NCT01439724|E1|Reported Event|Placebo|"Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.~Placebo (DMC, São Paulo, Brazil): The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light."
790390|NCT01439672|B1|Baseline|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
790391|NCT01439672|P1|Participant Flow|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
790424|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790576|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790392|NCT01439672|O1|Outcome|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity. Each subject will be admitted twice approximately 3 weeks apart.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
790393|NCT01439672|E1|Reported Event|Insulin Sensitivity|"Single arm. Each subject will consume a mixed meal beverage along with insulin administration in order to calculate insulin sensitivity.~Mixed meal and insulin challenge: The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100."
790394|NCT01439360|B3|Baseline|Total|Total of all reporting groups
790395|NCT01439360|B2|Baseline|Control|In function of their age and D-QIV-vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790396|NCT01439360|B1|Baseline|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790397|NCT01439360|P2|Participant Flow|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790398|NCT01439360|P1|Participant Flow|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790399|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790400|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790401|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790402|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790403|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790404|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790405|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790406|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790407|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790408|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790409|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790410|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790411|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790412|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790413|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790414|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790415|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790416|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790417|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790418|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790419|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790420|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790421|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790422|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
842834|NCT01255592|E1|Reported Event|AZD5069|80 mg bd
790425|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790426|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790427|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790428|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790429|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790430|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790431|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790432|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790433|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790434|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790435|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790436|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790437|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790438|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790439|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790440|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790441|NCT01439360|O2|Outcome|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790442|NCT01439360|O1|Outcome|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790443|NCT01439360|E2|Reported Event|Control|In function of their age and Influsplit™ Tetra (D-QIV) vaccine status, subjects received Prevenar 13® or Havrix® Junior and possibly a varicella vaccine (Varilrix® or Varivax/ProVarivax ®).
790444|NCT01439360|E1|Reported Event|D-QIV|Subjects received 1 or 2 doses of candidate influenza Influsplit™ Tetra vaccine (GSK2321138A).
790445|NCT01439282|B3|Baseline|Total|Total of all reporting groups
790446|NCT01439282|B2|Baseline|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790447|NCT01439282|B1|Baseline|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790448|NCT01439282|P2|Participant Flow|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790449|NCT01439282|P1|Participant Flow|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an intravenous (IV) infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally twice a day (BID) on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790450|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790473|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790577|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790451|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790452|NCT01439282|O2|Outcome|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (E7389) (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790453|NCT01439282|O1|Outcome|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790454|NCT01439282|E2|Reported Event|Cohort 2: Eribulin Mesylate Plus 1500 mg Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. A fixed dose of capecitabine (1500 mg) was administered orally BID on a 7/7 schedule (7days on and 7 days off) for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790455|NCT01439282|E1|Reported Event|Cohort 1: Eribulin Mesylate Plus 900 mg/m^2 Capecitabine|Eribulin mesylate (1.4 mg/m^2) was injected directly as an IV infusion over 2 to 5 minutes on Day 1 and Day 8 of the 21-day cycle for a total of 4 cycles. Alternatively, eribulin mesylate could be diluted in up to 100 mL in 0.9% sodium chloride for IV infusion over 2 to 5 minutes. Capecitabine (900 mg/m^2) was administered orally BID on Days 1 through 14 of a 21-day cycle for a total of 4 cycles. Capecitabine was to be taken approximately 30 minutes after breakfast and approximately 30 minutes after dinner.
790456|NCT01439204|B3|Baseline|Total|Total of all reporting groups
790457|NCT01439204|B2|Baseline|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790458|NCT01439204|B1|Baseline|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790459|NCT01439204|P2|Participant Flow|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790460|NCT01439204|P1|Participant Flow|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790461|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790462|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790463|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790464|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790465|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790466|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790467|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790468|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790469|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790470|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790471|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790472|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790527|NCT01439074|E2|Reported Event|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
790474|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790475|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790476|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790477|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790478|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790479|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790480|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790481|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790482|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790483|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790484|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790485|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790486|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790487|NCT01439204|O2|Outcome|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790488|NCT01439204|O1|Outcome|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790489|NCT01439204|E2|Reported Event|750 mg Abatacept From Lonza, NH|A single dose of abatacept 750 mg, manufactured at Lonza, New Hampshire facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790490|NCT01439204|E1|Reported Event|750 mg Abatacept From Devens, MA|A single dose of abatacept 750 mg, manufactured at Devens, Massachusetts facility, was administered intravenously (IV) using a calibrated, constant rate infusion pump over approximately 30 minutes.
790491|NCT01439126|B3|Baseline|Total|Total of all reporting groups
790492|NCT01439126|B2|Baseline|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790493|NCT01439126|B1|Baseline|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790494|NCT01439126|P2|Participant Flow|Subjects on Placebo|"Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study~Of 67 Subjects randomized to Placebo:~26 (38.8%) oral dose of 0.4 mg/day 24 (35.8%) oral dose of 0.3 mg/day 15 (22.4%) oral dose of 0.2 mg/day 2 (3.0%) oral dose of 0.1 mg/day"
790495|NCT01439126|P1|Participant Flow|Subjects on KAPVAY (Clonidine Hydrochloride)|"Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period.~All subjects were given study medication at the baseline visit (Visit 2, open label) and instructed to take 1 x 0.1 mg tablet each evening (Day 1) at bedtime until the next visit. Subjects who required an increase in total dose to 0.2 mg/day took 1 x 0.1 mg tablet (0.1 mg) in the morning and at bedtime until the next visit. Those who required a further increase in dose to 0.3 mg/day took 1 x 0.1 mg tablet in the morning and 2 x 0.1 mg tablets at bedtime until the next visit. Patient increasing dose to 0.4 mg/day were instructed to take 2 x 0.1 mg tablets in the morning and at bedtime until the next visit.~Of 68 Subjects randomized to KAPVAY:~24 (35.3%) oral dose of 0.4 mg/day 25 (36.8%) oral dose of 0.3 mg/day 14 (20.6%) oral dose of 0.2 mg/day 5 (7.4%) oral dose of 0.1 mg/day"
790496|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790497|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790498|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790499|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790500|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790501|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790502|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790503|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790504|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790505|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790506|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790507|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790508|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790509|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790510|NCT01439126|O2|Outcome|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790511|NCT01439126|O1|Outcome|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790512|NCT01439126|E2|Reported Event|Subjects on Placebo|Subjects randomized to the placebo arm were tapered off their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) at weekly intervals in decrements of 0.1 mg/day until reaching the dose of 0 mg/day, and then received only placebo for the rest of the study
790513|NCT01439126|E1|Reported Event|Subjects on KAPVAY (Clonidine Hydrochloride)|Subjects in the KAPVAY arm received their optimal dose of KAPVAY (as determined after a 4-week, open-label, dose optimization period) for the duration of the 26-week randomized-withdrawal period
790514|NCT01439074|B3|Baseline|Total|Total of all reporting groups
790515|NCT01439074|B2|Baseline|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
790516|NCT01439074|B1|Baseline|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
790517|NCT01439074|P2|Participant Flow|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
790518|NCT01439074|P1|Participant Flow|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
790519|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
790520|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
790521|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
790522|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
790523|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
790524|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
790525|NCT01439074|O2|Outcome|SSD Ag Cream|"Silver Sulphadiazine Ag cream~Silver sulphadiazine: Cream"
790526|NCT01439074|O1|Outcome|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
790528|NCT01439074|E1|Reported Event|Mepilex Ag|"Mepilex Ag consists of a Safetac(R) soft silicone wound contact layer, a grey absorbent polyurethane foam pad containing a silver compound, activated carbon, and a vapour permeable waterproof film.~Mepilex Ag: Dressing"
790529|NCT01438996|B4|Baseline|Total|Total of all reporting groups
790530|NCT01438996|B3|Baseline|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790531|NCT01438996|B2|Baseline|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790532|NCT01438996|B1|Baseline|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790533|NCT01438996|P3|Participant Flow|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790534|NCT01438996|P2|Participant Flow|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790535|NCT01438996|P1|Participant Flow|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790536|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790537|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790538|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790539|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790540|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790541|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790542|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790543|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790544|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790545|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790546|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790547|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790548|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790549|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790550|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790551|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790552|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790553|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790554|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790555|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790556|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790557|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790558|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790559|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790560|NCT01438996|O3|Outcome|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790561|NCT01438996|O2|Outcome|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790562|NCT01438996|O1|Outcome|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790563|NCT01438996|E3|Reported Event|NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
790564|NCT01438996|E2|Reported Event|Vi-PS/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01_04TP study
790565|NCT01438996|E1|Reported Event|NVGH Vi-CRM/NVGH Vi-CRM|One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01_04TP study
790566|NCT01438814|B3|Baseline|Total|Total of all reporting groups
790567|NCT01438814|B2|Baseline|Met Bid|Patients treated with metformin alone twice daily.
790568|NCT01438814|B1|Baseline|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790569|NCT01438814|P2|Participant Flow|Met Bid|Patients treated with metformin alone twice daily.
790570|NCT01438814|P1|Participant Flow|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790571|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790572|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790573|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790574|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790575|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
792018|NCT01433250|B2|Baseline|Placebo/AIN457|Placebo for core study and AIN in extension study
790580|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790581|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790582|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790583|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790584|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790585|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790586|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790587|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790588|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790589|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790590|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790591|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790592|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790593|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790594|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790595|NCT01438814|O2|Outcome|Met Bid|Patients treated with metformin alone twice daily.
790596|NCT01438814|O1|Outcome|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790597|NCT01438814|E2|Reported Event|Met Bid|Patients treated with metformin alone twice daily.
790598|NCT01438814|E1|Reported Event|Lina 5mg + Met qd|Patients treated with Linagliptin 5mg in combination with metformin once daily.
790599|NCT01438710|B1|Baseline|Prograf|"Tacrolimus capsules for twice daily oral administration~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
790600|NCT01438710|P2|Participant Flow|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
790601|NCT01438710|P1|Participant Flow|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
790602|NCT01438710|O1|Outcome|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
790603|NCT01438710|E2|Reported Event|Prograf|"All patients received Prograf/generic Tacrolimus capsules for twice daily oral administration during the first week of treatment.~Prograf: Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice."
790604|NCT01438710|E1|Reported Event|LCP-Tacro|"After the first weeks treatment with Prograf/generic Tacrolimus, all patients were switched to LCP Tacro tables for once daily oral administration for one week.~LCP-Tacro: LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL."
790605|NCT01438541|B1|Baseline|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
790606|NCT01438541|P1|Participant Flow|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
790607|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
790608|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
790609|NCT01438541|O1|Outcome|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
790610|NCT01438541|E1|Reported Event|Window|WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown.
790611|NCT01438489|B4|Baseline|Total|Total of all reporting groups
790612|NCT01438489|B3|Baseline|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790613|NCT01438489|B2|Baseline|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790614|NCT01438489|B1|Baseline|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790615|NCT01438489|P3|Participant Flow|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790616|NCT01438489|P2|Participant Flow|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790617|NCT01438489|P1|Participant Flow|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790618|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
829126|NCT01297062|E1|Reported Event|Exenatide|Exenatide
790619|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790620|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790621|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790622|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790623|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790624|NCT01438489|O2|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790625|NCT01438489|O1|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790626|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790627|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790628|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790629|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790630|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790631|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790632|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790633|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790634|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790635|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790636|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790637|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790638|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790639|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790640|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790641|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790642|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790643|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790644|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790645|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790646|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790647|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790648|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790649|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790650|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790651|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790652|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790653|NCT01438489|O3|Outcome|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790654|NCT01438489|O2|Outcome|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790655|NCT01438489|O1|Outcome|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790656|NCT01438489|E3|Reported Event|Anifrolumab 1000 mg|Participants received 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790657|NCT01438489|E2|Reported Event|Anifrolumab 300 mg|Participants received 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
790658|NCT01438489|E1|Reported Event|Placebo|Participants received placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
790659|NCT01438424|B1|Baseline|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790660|NCT01438424|P1|Participant Flow|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790661|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790798|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790662|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790663|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790664|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790665|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790666|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
790667|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790668|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790669|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790670|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790671|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
790672|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790673|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790674|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790675|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790676|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790677|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790678|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790679|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
790680|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
790681|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
790682|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790683|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg QD, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir once daily (QD) with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine. All participants, regardless of dosing or regimen, included in these safety analyses.
790684|NCT01438424|O1|Outcome|Entecavir, 1.0 mg, With or Without Lamivudine|Participants received 1 mg of entecavir QD with or without lamivudine.
790685|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790686|NCT01438424|O1|Outcome|Entecavir, 0.5 or 1.0 mg, With or Without Lamivudine|Participants originally received 0.5 mg of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790687|NCT01438424|E8|Reported Event|Placebo|Participants originally assigned to placebo before protocol change to study drug.
790688|NCT01438424|E7|Reported Event|Missing|Category missing
790689|NCT01438424|E6|Reported Event|Lamovidine, 100 mg|Participants originally received lamovidine with entecavir
790690|NCT01438424|E5|Reported Event|Entecavir, 1.0 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790691|NCT01438424|E4|Reported Event|Entecavir, 0.5 mg|Participants received entecavir QD with lamovidine
790692|NCT01438424|E3|Reported Event|Entecavir, 0.1 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790693|NCT01438424|E2|Reported Event|Entecavir, 0.02588 mg|Participants originally received lower doses of entecavir QD with lamivudine, but protocol later amended to 1.0 mg of entecavir QD without lamivudine.
790694|NCT01438424|E1|Reported Event|Adefovir, 10 mg|Participants who received adefovir concomitantly at postdosing follow-up
790695|NCT01438307|B3|Baseline|Total|Total of all reporting groups
790696|NCT01438307|B2|Baseline|Schedule B|Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.
790697|NCT01438307|B1|Baseline|Schedule A|Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.
790698|NCT01438307|P2|Participant Flow|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
790699|NCT01438307|P1|Participant Flow|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
790700|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
790701|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
790702|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
790703|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
790704|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
790705|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
790718|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
792019|NCT01433250|B1|Baseline|AIN457/ AIN457|AIN in core study , continued AIN in extension study
790706|NCT01438307|O2|Outcome|Schedule B|"Subjects with advanced NSCLC who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258, different from Schedule A.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (5-week cycle): Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual de"
790707|NCT01438307|O1|Outcome|Schedule A|"Subjects with advanced non-small cell lung cancer who have been previously treated will be given a specific regimen of the novel taxane, Cabazitaxel-XRP6258.~Subjects with asymptomatic brain metastases will be eligible for the study and a subset analysis will take place to help determine what, if any, effect Cabazitaxel-XRP6258 has on brain metastases.~Cabazitaxel-XRP6258 (3-week cycle): Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator."
790708|NCT01438307|E2|Reported Event|Treatment Schedule B|"Cabazitaxel 8.4 mg/m2 weekly on Days 1, 85, 15, and 22 of a 5 week cycle with a planned dose escalation to 10 mg/m2 weekly if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
790709|NCT01438307|E1|Reported Event|Treatment Schedule A|"Cabazitaxel 20 mg/m2 every 3 weeks as a 1 hour IV infusion with a planned dose escalation of to 25 mg/m2 if no dose limiting toxicities (DLTs) were observed.~All subjects will be followed for survival/progression after every 2 cycles of therapy with imaging studies."
790710|NCT01438294|B3|Baseline|Total|Total of all reporting groups
790711|NCT01438294|B2|Baseline|Video Game|"The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( reflex ridge- Adventure).~Video game group: The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge)."
790712|NCT01438294|B1|Baseline|Aerobic Exercise|"The aerobic training will be done on the treadmill with heart monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.~Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011)."
790713|NCT01438294|P2|Participant Flow|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
790714|NCT01438294|P1|Participant Flow|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
790715|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
790716|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
790717|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
790719|NCT01438294|O2|Outcome|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
790720|NCT01438294|O1|Outcome|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
790721|NCT01438294|E2|Reported Event|Video Game|The game “Reflex Ridge” of Kinect Adventure (XBOX 360 KinectTM, Microsoft, USA) was used for training. A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, children played video game, each session lasted 30 minutes and was performed in 10 rounds each one lasting 3 minutes with a 30-second rest interval between rounds. The video game intensity was increased with each round, requiring the child to perform a greater number of jumps, squats, lateral movements and arm movements. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM , USA).
790722|NCT01438294|E1|Reported Event|Aerobic Exercise|Aerobic exercise group: A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
790723|NCT01438229|B1|Baseline|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790724|NCT01438229|P1|Participant Flow|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790725|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790726|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790727|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790728|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790729|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790730|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790731|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790732|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790733|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790734|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790735|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790736|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790737|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790738|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
792030|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
790739|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790740|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790741|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790742|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790743|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790744|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790745|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790746|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790747|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790748|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790749|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790750|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790751|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790752|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790753|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790754|NCT01438229|O1|Outcome|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790755|NCT01438229|E1|Reported Event|Renal Artery Ablation|"Catheter-based RF ablation in renal artery~St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002): Catheter-based RF ablation in renal artery"
790756|NCT01438177|B1|Baseline|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
790757|NCT01438177|P1|Participant Flow|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
790758|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
790759|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
790760|NCT01438177|O1|Outcome|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
790761|NCT01438177|E1|Reported Event|Velcade+Cyclophosphamide+Chloroquine|"VELCADE given by intravenous push at 1.3 mg/m^2 on days 1, 4, 8, 11, 22, 25, 29 and 32.~Cyclophosphamide given at 50 mg orally twice per day on days 1-14 and 22-35.~Chloroquine given at 500 mg orally daily on days 1-14 and 22-35.~Each cycle is 42 days in length."
790794|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790795|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790796|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790797|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790762|NCT01438151|B1|Baseline|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
790763|NCT01438151|P1|Participant Flow|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
790764|NCT01438151|O1|Outcome|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
790765|NCT01438151|E1|Reported Event|Remicade|"If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.~Remicade: The first potential for dose augmentation will be at infusion #3. Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved."
790766|NCT01438060|B3|Baseline|Total|Total of all reporting groups
790767|NCT01438060|B2|Baseline|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790768|NCT01438060|B1|Baseline|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
790769|NCT01438060|P2|Participant Flow|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790770|NCT01438060|P1|Participant Flow|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
790771|NCT01438060|O1|Outcome|Aripiprazole|Treatment beyond 140 weeks: Dosed at 2-15 mg/day (flexible dosing).
790772|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790773|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790774|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790775|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790776|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790777|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790778|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790779|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790780|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790781|NCT01438060|O1|Outcome|Aripiprazole|Aripiprazole dosed at 2 mg (Week 11), 2-5 mg/day (Weeks 12-13), 2-10 mg/day (Weeks 14-15), 2-15 mg/day (Weeks 16-140).
790782|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790783|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790784|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: Dosed at 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790785|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks)
790786|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790787|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790788|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790789|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790790|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790791|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790792|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790793|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790984|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
790800|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790801|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790802|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790803|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790804|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790805|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790806|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790807|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790808|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790809|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790810|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790811|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790812|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790813|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790814|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790815|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790816|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790817|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790818|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790819|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790820|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790821|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790822|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790823|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790824|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790825|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790826|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790827|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790828|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790829|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790830|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790831|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790832|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790833|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790834|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790835|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790836|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790837|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790838|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790839|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790840|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790841|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790842|NCT01438060|O2|Outcome|Aripiprazole|Acute Phase: 2 mg/day (Week 1-2), 2-5 mg/day (Week 3-4), 2-10 mg/day (Week 5-6), 2-15 mg/day (Weeks 7-10).
790843|NCT01438060|O1|Outcome|Placebo|Acute Phase: 0 mg, Once daily (10 Weeks
790844|NCT01438060|E3|Reported Event|3 Ext - Aripiprazole|
790845|NCT01438060|E2|Reported Event|2 Double Blind Placebo|
790846|NCT01438060|E1|Reported Event|1 Double Blind Aripiprazole|
790847|NCT01437995|B4|Baseline|Total|Total of all reporting groups
790848|NCT01437995|B3|Baseline|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790849|NCT01437995|B2|Baseline|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790850|NCT01437995|B1|Baseline|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790851|NCT01437995|P3|Participant Flow|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790934|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
790852|NCT01437995|P2|Participant Flow|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790853|NCT01437995|P1|Participant Flow|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790854|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790855|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790856|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790857|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790858|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790859|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790860|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790861|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790862|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790863|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790864|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790865|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790866|NCT01437995|O3|Outcome|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790867|NCT01437995|O2|Outcome|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790868|NCT01437995|O1|Outcome|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790869|NCT01437995|E3|Reported Event|LABA Step Off|"Fluticasone Diskus alone 250 ug twice daily without Salmeterol~Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol"
790870|NCT01437995|E2|Reported Event|Reduced ICS/LABA|"Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily~Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily"
790871|NCT01437995|E1|Reported Event|Stable ICS-LABA|"Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily~Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily"
790872|NCT01437943|B3|Baseline|Total|Total of all reporting groups
790873|NCT01437943|B2|Baseline|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet (0 mg) daily for 180 days"
790874|NCT01437943|B1|Baseline|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
790875|NCT01437943|P2|Participant Flow|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet by mouth daily for 180 days"
790876|NCT01437943|P1|Participant Flow|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
790877|NCT01437943|O2|Outcome|Placebo|"Placebo identical to Aliskiren drug daily for 180 days~Placebo: Take 1 tablet (0 mg) daily for 180 days."
790878|NCT01437943|O1|Outcome|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
790879|NCT01437943|E2|Reported Event|Placebo|"Placebo daily for 180 days~Placebo: Take 1 tablet by mouth daily for 180 days"
790880|NCT01437943|E1|Reported Event|Aliskiren|"Aliskiren 150 mg daily for 180 days~Aliskiren: Take 1 tablet (150 mg) by mouth daily for 180 days"
790881|NCT01437878|B3|Baseline|Total|Total of all reporting groups
790882|NCT01437878|B2|Baseline|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790883|NCT01437878|B1|Baseline|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790884|NCT01437878|P2|Participant Flow|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790885|NCT01437878|P1|Participant Flow|Iloprost|"single dose inhalation using the power disc-6 with I-neb Adaptive Aerosol Delivery (AAD) system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790886|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790887|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790888|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790889|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790890|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
846600|NCT01243892|B3|Baseline|Total|Total of all reporting groups
790891|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790892|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790893|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790894|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790895|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790896|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790897|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790898|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790899|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790900|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790901|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790902|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790903|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790904|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790905|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790906|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790907|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790908|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790909|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790910|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790911|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790912|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790913|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790914|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790915|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790916|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790917|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790918|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790919|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790920|NCT01437878|O2|Outcome|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790921|NCT01437878|O1|Outcome|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790922|NCT01437878|E2|Reported Event|Placebo|"matching placebo using the power disc-6 with I-neb AAD system~Placebo: matching placebo"
790923|NCT01437878|E1|Reported Event|Iloprost|"single dose inhalation using the power disc-6 with I-neb AAD system~Iloprost: 5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks"
790924|NCT01437540|B3|Baseline|Total|Total of all reporting groups
790925|NCT01437540|B2|Baseline|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
790926|NCT01437540|B1|Baseline|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
790927|NCT01437540|P2|Participant Flow|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
790928|NCT01437540|P1|Participant Flow|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
790929|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
790930|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
790931|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
790932|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
790933|NCT01437540|O2|Outcome|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
790936|NCT01437540|O1|Outcome|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
790937|NCT01437540|E2|Reported Event|Formoterol 12 μg|Formoterol 12 μg administered BID via dry-powder inhaler
790938|NCT01437540|E1|Reported Event|Aclidinium/Formoterol 400 μg/12 μg|Aclidinium bromide/formoterol 400 μg/12 μg administered BID via dry-powder inhaler
790939|NCT01437501|B3|Baseline|Total|Total of all reporting groups
790940|NCT01437501|B2|Baseline|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
790941|NCT01437501|B1|Baseline|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
790942|NCT01437501|P2|Participant Flow|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
790943|NCT01437501|P1|Participant Flow|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
790944|NCT01437501|O2|Outcome|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
790945|NCT01437501|O1|Outcome|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
790946|NCT01437501|E2|Reported Event|Placebo Beverage|placebo beverage : 100 mL of dilute pineapple and lime juice daily for 84 days.
790947|NCT01437501|E1|Reported Event|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage : Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
790948|NCT01437423|B1|Baseline|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
790949|NCT01437423|P1|Participant Flow|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
790950|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
790951|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
790952|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
790953|NCT01437423|O1|Outcome|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
790954|NCT01437423|E1|Reported Event|TETRAXIM™ Vaccination and Booster Group|Children under 12 years old who received the 3-dose primary series injection of TETRAXIM™ vaccination and booster, were enrolled during the 6-year surveillance period, and whose case report forms were retrieved.
790955|NCT01437397|B6|Baseline|Total|Total of all reporting groups
790956|NCT01437397|B5|Baseline|Placebo|Administered BID by inhalation
790957|NCT01437397|B4|Baseline|Formoterol 12 μg|Administered BID by inhalation
790958|NCT01437397|B3|Baseline|Aclidinium 400 μg|Administered BID by inhalation
790959|NCT01437397|B2|Baseline|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
790960|NCT01437397|B1|Baseline|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
790961|NCT01437397|P5|Participant Flow|Placebo|Administered BID by inhalation
790962|NCT01437397|P4|Participant Flow|Formoterol 12 μg|Administered BID by inhalation
790963|NCT01437397|P3|Participant Flow|Aclidinium 400 μg|Administered BID by inhalation
790964|NCT01437397|P2|Participant Flow|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
790965|NCT01437397|P1|Participant Flow|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
790966|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
790967|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
790968|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
790969|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
790970|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
790971|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
790972|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
790973|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
790974|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
790975|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
790976|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
790977|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
790978|NCT01437397|O3|Outcome|Aclidinium 400 μg|Administered BID by inhalation
790979|NCT01437397|O2|Outcome|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
790980|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
790981|NCT01437397|O5|Outcome|Placebo|Administered BID by inhalation
790982|NCT01437397|O4|Outcome|Formoterol 12 μg|Administered BID by inhalation
790985|NCT01437397|O1|Outcome|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
790986|NCT01437397|E5|Reported Event|Placebo|Administered BID by inhalation
790987|NCT01437397|E4|Reported Event|Formoterol 12 μg|Administered BID by inhalation
790988|NCT01437397|E3|Reported Event|Aclidinium 400 μg|Administered BID by inhalation
790989|NCT01437397|E2|Reported Event|Aclidinium/Formoterol 400/6 μg|Fixed-dose combination (FDC) administered BID by inhalation
790990|NCT01437397|E1|Reported Event|Aclidinium/Formoterol 400/12 μg|Fixed-dose combination (FDC) administered BID by inhalation
790991|NCT01437319|B1|Baseline|Overall|The analysis population consists of all subjects that were enrolled into the study.
790992|NCT01437319|P3|Participant Flow|Balfilcon A|Subjects that received balafilcon A lens in Phase II.
790993|NCT01437319|P2|Participant Flow|Comfilcon A|Subjects that received comfilcon A lens in Phase II.
790994|NCT01437319|P1|Participant Flow|Lotrafilcon A|All subjects received lotrafilcon A in Phase I.
790995|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former
790996|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former
790997|NCT01437319|O2|Outcome|Non-repeat Mucin Ball Former|Subjects that were classified as Non-repeat Mucin Ball Former.
790998|NCT01437319|O1|Outcome|Repeat Mucin Ball Former|Subjects that were classified as being repeat Mucin Ball former.
790999|NCT01437319|E3|Reported Event|Lotrafilcon A|All Subjects received lotrafilcon A in Phase I of the study.
791000|NCT01437319|E2|Reported Event|Balafilcon A|Subjects who received balafilcon A in Phase II of the study
791001|NCT01437319|E1|Reported Event|Comfilcon A|Subjects who received comfilcon A in Phase II of the study.
791002|NCT01437267|B7|Baseline|Total|Total of all reporting groups
791003|NCT01437267|B6|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791004|NCT01437267|B5|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791005|NCT01437267|B4|Baseline|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791006|NCT01437267|B3|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791007|NCT01437267|B2|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791008|NCT01437267|B1|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791009|NCT01437267|P6|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791010|NCT01437267|P5|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791011|NCT01437267|P4|Participant Flow|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791012|NCT01437267|P3|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791013|NCT01437267|P2|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791014|NCT01437267|P1|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791015|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791016|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791017|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791018|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791019|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791020|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791021|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791022|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791023|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791024|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791025|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791026|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791027|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791028|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791029|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791030|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791031|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791032|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791033|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791034|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791035|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791036|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791037|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791038|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791039|NCT01437267|O6|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791040|NCT01437267|O5|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791041|NCT01437267|O4|Outcome|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791042|NCT01437267|O3|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791043|NCT01437267|O2|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791044|NCT01437267|O1|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791045|NCT01437267|E6|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
791046|NCT01437267|E5|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
791047|NCT01437267|E4|Reported Event|PNC13, Older Infants|Older infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
791048|NCT01437267|E3|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791049|NCT01437267|E2|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
791050|NCT01437267|E1|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
791051|NCT01437124|B1|Baseline|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
791052|NCT01437124|P1|Participant Flow|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
791053|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
791054|NCT01437124|O1|Outcome|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
791055|NCT01437124|E1|Reported Event|Ceramic on Metal THA|Those who have received a ceramic on metal total hip replacement
791056|NCT01437111|B1|Baseline|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
791057|NCT01437111|P1|Participant Flow|Fosamax Plus: All Participants|All participants who were enrolled in the study to receive one oral combination tablet of Fosamax Plus weekly.
791058|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
791059|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
791060|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
791061|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
791062|NCT01437111|O4|Outcome|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
791063|NCT01437111|O3|Outcome|Fosamax Plus: Treatment Naive at Baseline|Participants that were treatment-naïve or not recently treated at baseline were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
791064|NCT01437111|O2|Outcome|Fosamax Plus: Other Osteoporosis Therapy at Baseline|Participants receiving other osteoporosis drugs at baseline (besides bisphosphonate, strontium, estrogen, or SERM) were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
791065|NCT01437111|O1|Outcome|Fosamax Plus: Recent/Current Osteoporosis Therapy at Baseline|Participants receiving recent/current osteoporosis therapy at baseline (including bisphosphonate, strontium, estrogen, or SERM were administered open-label alendronate sodium 70 mg+Vitamin D3 5600 IU combination tablet (Fosamax Plus D) orally once a week for 26 weeks.
791066|NCT01437111|E1|Reported Event|Fosamax Plus: All Treated Participants|All participants who received at least one oral dose combination tablet of Fosamax Plus.
791067|NCT01437098|B1|Baseline|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
791068|NCT01437098|P1|Participant Flow|MDT-2111 TAVI|Transcatheter Aortic Valve Implantation (TAVI) with MDT-2111 system.
791069|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791070|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791071|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791072|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791073|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791074|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791130|NCT01436799|E1|Reported Event|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
791131|NCT01436643|B4|Baseline|Total|Total of all reporting groups
792034|NCT01433250|E2|Reported Event|AIN457(Core)/AIN457(Extension)|AIN457(core)/AIN457(extension)
791075|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791076|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791077|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791078|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791079|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791080|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791081|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791082|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791083|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791084|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791085|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791086|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791087|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791088|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791089|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791090|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791091|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791092|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791093|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791094|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791095|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791096|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791097|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791098|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791099|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791100|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791101|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791102|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791103|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791698|NCT01435265|E1|Reported Event|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
791104|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
791105|NCT01437098|O1|Outcome|As Treated Population With Index Procedure|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed. Index procedure was defined as introduction of the MDT-2111 TAV system delivery catheter.
791106|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
791107|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed..
791108|NCT01437098|O1|Outcome|As Treated (AT) Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791109|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791110|NCT01437098|O1|Outcome|As Treated Population|The As Treated (AT) population was defined as subjects with an attempted implant procedure, identified as subject entry to the procedure room and any of the following occurrences: anesthesia administered, vascular line placed, transesophageal echo (TEE) placed, or any monitoring line placed.
791111|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791112|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791113|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791114|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791115|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791116|NCT01437098|O2|Outcome|Iliofemoral Implanted Subjects|The IF Implanted population consisted of all IF As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791117|NCT01437098|O1|Outcome|All Implanted Subjects|The Implanted population consisted of all As Treated Subjects who underwent an index procedure and were implanted with the MDT-2111 device.
791118|NCT01437098|E4|Reported Event|All Subjects (As Treated Subjects)|This includes subjects from all access approaches, iliofemoral, subclavian and direct aortic.
791119|NCT01437098|E3|Reported Event|Direct Aortic (As Treated Subjects)|For patients who would benefit from the therapy but have unfavorable non-aortic vasculature of the transfemoral and subclavian/axillary access sites (i.e. excessive atherosclerosis, calcifications, or tortuosity of arteries), the direct aortic approach is currently being used in oversea(EU and US) in clinical practice with similar outcomes to transfemoral and subclavian/ axillary artery approaches.
791120|NCT01437098|E2|Reported Event|Subclavian (As Treated Subjects)|The subclavian access is additionally chosen (as the secondary access site) when physicians may require an alternative to the femoral access site for patients who would benefit from the therapy but have unfavorable peripheral vasculature such as excessive atherosclerosis, calcifications, or tortuosity of common femoral arteries.
791121|NCT01437098|E1|Reported Event|Iliofemoral (As Treated Subjects)|The iliofemoral approach is used as the primary access site because there is a large body of clinical data in the past using this approach in patients.
791122|NCT01436799|B3|Baseline|Total|Total of all reporting groups
791123|NCT01436799|B2|Baseline|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
791124|NCT01436799|B1|Baseline|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
791125|NCT01436799|P2|Participant Flow|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
791126|NCT01436799|P1|Participant Flow|Desflurane|anaesthesia was induced with thiopental sodium 2 mg kg-1, alfentanil 10 μg kg-1 and rocuronium 0.6 mg kg-1. Anesthetic maintenance by desflurane
791127|NCT01436799|O2|Outcome|Propofol|anesthetic maintanence with propofol
791128|NCT01436799|O1|Outcome|Desflurane|anesthetic maintenence with desflurane
791129|NCT01436799|E2|Reported Event|Propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1, alfentanil 10 μg kg-1, and rocuronium 0.6 mg kg-1. A commercially available target controlled infusion (TCI) pump (Orchestra®, Fresenius Vial, France) was used and the pharmacokinetic set used to calculate target effect-site concentrations for propofol was Schnider and colleagues' model
792031|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
791132|NCT01436643|B3|Baseline|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
791133|NCT01436643|B2|Baseline|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
791134|NCT01436643|B1|Baseline|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
791135|NCT01436643|P4|Participant Flow|Pre-treatment With Fingolimod|During 2weeks pre-treatment period patients received Fingolimod 0.5 mg per capsule (hard gelatin capsules) orally once daily.
791136|NCT01436643|P3|Participant Flow|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
791137|NCT01436643|P2|Participant Flow|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
791138|NCT01436643|P1|Participant Flow|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
791139|NCT01436643|O4|Outcome|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
791140|NCT01436643|O3|Outcome|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
791141|NCT01436643|O2|Outcome|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
791142|NCT01436643|O1|Outcome|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
791143|NCT01436643|E4|Reported Event|Fluoxetine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Fluoxetine, supplied in blistered packs containing 20 tablets; starting dose 20 mg; final dose 40 mg
791144|NCT01436643|E3|Reported Event|Citalopram and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Citalopram, supplied in blistered packs containing 20 tablets; starting dose 20 mg, final dose 40 mg
791145|NCT01436643|E2|Reported Event|Venlafaxine and Fingolimod|Fingolimod 0.5 mg per capsule(hard gelatin capsules) was taken p.o. once daily. Venlafaxine, supplied in blistered packs containing 14 capsules; starting dose 75 mg; final dose 150 mg
791146|NCT01436643|E1|Reported Event|Fingolimod|2 Week Pre-treatment Period: Fingolimod 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once during 2 week pre-treatment period.
791147|NCT01436526|B3|Baseline|Total|Total of all reporting groups
791148|NCT01436526|B2|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
791149|NCT01436526|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg , Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
791150|NCT01436526|P2|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 1*10 mg, Then 2*5 mg|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
791151|NCT01436526|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939) First 2*5 mg, Then 1*10 mg|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
791152|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
791153|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791154|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
791155|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791156|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
791157|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791158|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
791159|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791160|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
791161|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791162|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
791163|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791164|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
791165|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791166|NCT01436526|O2|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 1*10 mg|Single oral dose of 1*10 mg rivaroxaban tablets administered under fasting conditions
829127|NCT01296841|B3|Baseline|Total|Total of all reporting groups
791167|NCT01436526|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939) 2*5 mg|Single oral dose of 2*5 mg rivaroxaban tablet administered under fasting conditions
791168|NCT01436526|E2|Reported Event|Rivaroxaban 1*10 mg (Xarelto, BAY59-7939)|Single oral dose of 1*10 mg rivaroxaban tablet administered under fasting conditions
791169|NCT01436526|E1|Reported Event|Rivaroxaban 2*5 mg (Xarelto, BAY59-7939)|Single oral dose of 2*5 mg rivaroxaban tablets administered under fasting conditions
791170|NCT01436500|B3|Baseline|Total|Total of all reporting groups
791171|NCT01436500|B2|Baseline|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
791172|NCT01436500|B1|Baseline|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791173|NCT01436500|P5|Participant Flow|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
791174|NCT01436500|P4|Participant Flow|150 mg Ifetroban|150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791175|NCT01436500|P3|Participant Flow|50 mg Ifetroban|50 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791176|NCT01436500|P2|Participant Flow|15 mg Ifetroban|15 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791177|NCT01436500|P1|Participant Flow|5 mg Ifetroban|5 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791178|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
791179|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791180|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
791181|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791182|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
791183|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791184|NCT01436500|O2|Outcome|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
791185|NCT01436500|O1|Outcome|Ifetroban Injection|5, 15, 50, or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791186|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791187|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791188|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791189|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791190|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791191|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791192|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791193|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791194|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791195|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791196|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791197|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791198|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791199|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791200|NCT01436500|O7|Outcome|150 mg Ifetroban, Type 2|"60-minute intravenous infusion of 150 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791201|NCT01436500|O6|Outcome|50 mg Ifetroban, Type 2|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791202|NCT01436500|O5|Outcome|50 mg Ifetroban, Type 1|"60-minute intravenous infusion of 50 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791203|NCT01436500|O4|Outcome|15 mg Ifetroban, Type 2|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 2 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791204|NCT01436500|O3|Outcome|15 mg Ifetroban, Type 1|"60-minute intravenous infusion of 15 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791205|NCT01436500|O2|Outcome|5 mg Ifetroban, Type 2|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791206|NCT01436500|O1|Outcome|5 mg Ifetroban, Type 1|"60-minute intravenous infusion of 5 mg ifetroban given once daily for 3 days to subjects with Type 1 HRS.~Ifetroban Injection: Ifetroban sodium injectable, diluted in sterile water with 5% dextrose"
791207|NCT01436500|E2|Reported Event|Placebo|5% Dextrose in Water administered IV over 60 minutes once daily x 3 days
791208|NCT01436500|E1|Reported Event|Ifetroban|5, 15, 50 or 150 mg Ifetroban Injection administered IV over 60 minutes once daily x 3 days
791209|NCT01436435|B1|Baseline|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791210|NCT01436435|P1|Participant Flow|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791211|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791212|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791213|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791214|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791215|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791216|NCT01436435|O1|Outcome|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791217|NCT01436435|E1|Reported Event|Jetstream Atherectomy System|"Patients with symptomatic peripheral vascular disease undergoing percutaneous intervention including Atherectomy utilizing the Jetstream Atherectomy System with or without adjunctive therapy.~Jetstream Atherectomy System: Atherectomy"
791218|NCT01436370|B9|Baseline|Total|Total of all reporting groups
791219|NCT01436370|B8|Baseline|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791220|NCT01436370|B7|Baseline|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791221|NCT01436370|B6|Baseline|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791222|NCT01436370|B5|Baseline|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791223|NCT01436370|B4|Baseline|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791224|NCT01436370|B3|Baseline|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791225|NCT01436370|B2|Baseline|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791226|NCT01436370|B1|Baseline|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791227|NCT01436370|P8|Participant Flow|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791228|NCT01436370|P7|Participant Flow|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791229|NCT01436370|P6|Participant Flow|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791230|NCT01436370|P5|Participant Flow|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791231|NCT01436370|P4|Participant Flow|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791232|NCT01436370|P3|Participant Flow|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791233|NCT01436370|P2|Participant Flow|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791234|NCT01436370|P1|Participant Flow|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791235|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791236|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791237|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791238|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791239|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791240|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791241|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791242|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791243|NCT01436370|O4|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791244|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791245|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791246|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791247|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791248|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791249|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791250|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791251|NCT01436370|O2|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791252|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791253|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791254|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791255|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791256|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791257|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791258|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791259|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791260|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791261|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791262|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791263|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791264|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
792032|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
791265|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791266|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791267|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791268|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791269|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791270|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791271|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791272|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791273|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791274|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791275|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791276|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791277|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791278|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791279|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791280|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791281|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791282|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791283|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791284|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791285|NCT01436370|O4|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791286|NCT01436370|O3|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791287|NCT01436370|O2|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791288|NCT01436370|O1|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791289|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791290|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791291|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791292|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791293|NCT01436370|O8|Outcome|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791294|NCT01436370|O7|Outcome|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791295|NCT01436370|O6|Outcome|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791296|NCT01436370|O5|Outcome|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791297|NCT01436370|O4|Outcome|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791298|NCT01436370|O3|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791299|NCT01436370|O2|Outcome|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791300|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791301|NCT01436370|O2|Outcome|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791302|NCT01436370|O1|Outcome|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791303|NCT01436370|E8|Reported Event|Healthy Controls, 2012-2013 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791304|NCT01436370|E7|Reported Event|RA Participants, 2012-2013 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone® High Dose
791305|NCT01436370|E6|Reported Event|Healthy Controls, 2012-2013 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791306|NCT01436370|E5|Reported Event|RA Participants, 2012-2013 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2012-2013 Sanofi Pasteur Fluzone®
791307|NCT01436370|E4|Reported Event|Healthy Controls, 2011-2012 Fluzone High Dose|Healthy gender and age-matched controls were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791308|NCT01436370|E3|Reported Event|RA Participants, 2011-2012 Fluzone High Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 60 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone® High Dose
791309|NCT01436370|E2|Reported Event|Healthy Controls, 2011-2012 Fluzone Standard Dose|Healthy gender and age-matched controls were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791310|NCT01436370|E1|Reported Event|RA Participants, 2011-2012 Fluzone Standard Dose|Adults with Rheumatoid Arthritis receiving TNF-alpha-inhibitor therapy were given a single 15 mcg intramuscular dose of 2011-2012 Sanofi Pasteur Fluzone®
791311|NCT01436279|B3|Baseline|Total|Total of all reporting groups
791312|NCT01436279|B2|Baseline|Osmotic Dilators|Placed 20-24 hours prior to procedure
791313|NCT01436279|B1|Baseline|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
791314|NCT01436279|P2|Participant Flow|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
791315|NCT01436279|P1|Participant Flow|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
791316|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
791317|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
791318|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
791319|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
791320|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
791321|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
791322|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
791323|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
791324|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
791325|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
791326|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
791327|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
791328|NCT01436279|O2|Outcome|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
791329|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
791330|NCT01436279|O2|Outcome|Osmotic Dilators|Placed 20-24 hours prior to procedure
791331|NCT01436279|O1|Outcome|Mifepristone + Misoprostol|Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure
791332|NCT01436279|E2|Reported Event|Osmotic Dilators|"Placed 20-24 hours prior to procedure~osmotic dilators: osmotic dilators placed in the cervix 20-24 hours prior to the procedure"
791836|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
791333|NCT01436279|E1|Reported Event|Mifepristone + Misoprostol|"Mifepristone 200 mg PO given 20-24 hours prior to procedure, misoprostol 400 mcg given 2 hours prior to procedure~Mifepristone: 200 mg po 20-24 hours prior to the procedure"
791334|NCT01436266|B3|Baseline|Total|Total of all reporting groups
791335|NCT01436266|B2|Baseline|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
791336|NCT01436266|B1|Baseline|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
791337|NCT01436266|P2|Participant Flow|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
791338|NCT01436266|P1|Participant Flow|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
791339|NCT01436266|O2|Outcome|Placebo Comparator: Placebo (Folic Acid)|Two 1-mg tablets buccally 2 hours prior to procedure
791340|NCT01436266|O1|Outcome|Active Comparator: Misoprostol|400 mcg buccally 2 hours prior to procedure
791341|NCT01436266|E2|Reported Event|Placebo (Folic Acid)|"Two 1-mg tablets buccally 2 hours prior to procedure~Folic acid: 2mg buccally 2 hours prior to procedure"
791342|NCT01436266|E1|Reported Event|Misoprostol|"400 mcg buccally 2 hours prior to procedure~Misoprostol: 400 mcg buccally 2 hours prior to procedure"
791343|NCT01436253|B1|Baseline|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
791344|NCT01436253|P1|Participant Flow|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
791345|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
791346|NCT01436253|O1|Outcome|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid values on their current therapy.
791347|NCT01436253|E1|Reported Event|All Participants|Participants in Croatia being treated in Physician Offices for hyperlipidemia who have not achieved target lipid levels on their current therapy.
791348|NCT01436201|B1|Baseline|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
791349|NCT01436201|P1|Participant Flow|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
791350|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
791351|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
791352|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
791353|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
791354|NCT01436201|O2|Outcome|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
791355|NCT01436201|O1|Outcome|Digoxin Only|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
791356|NCT01436201|E2|Reported Event|Digoxin + Dulaglutide|"Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 8 to Day 17.~Dulaglutide (LY2189265): 1.5 mg, subcutaneous injection, once on Day 8 and once on Day 15."
791357|NCT01436201|E1|Reported Event|Digoxin|Digoxin: Two 0.5-milligram (mg) doses, administered orally, 12 hours apart on Day 1 (1 mg total on Day 1); 0.25 mg, orally, once daily on Day 2 to Day 7.
791358|NCT01436175|B1|Baseline|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791359|NCT01436175|P1|Participant Flow|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791360|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791361|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791362|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
792020|NCT01433250|P2|Participant Flow|AIN Placebo/ AIN457 Extension|"Placebo in core study and AIN in extension study~(10 mg/kg iv every four weeks)"
791363|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791364|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791365|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791366|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791367|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791368|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 (Lisdexamfetamine dimesylate) + Antidepressant: SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
791369|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791370|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791371|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791372|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791373|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791374|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791375|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791376|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791377|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791378|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791379|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791380|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
792033|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
791381|NCT01436175|O1|Outcome|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791382|NCT01436175|E1|Reported Event|SPD489 + Antidepressant|SPD489 20, 30, 50 or 70 milligram (mg) once daily orally for 52 weeks along with the assigned background product that participant had received during the antecedent study (antidepressant: either escitalopram oxalate, sertraline hydrochloride [HCl], venlafaxine HCl extended-release, or duloxetine HCl) at a dose consistent with applicable local labeling guidelines.
791383|NCT01436162|B3|Baseline|Total|Total of all reporting groups
791384|NCT01436162|B2|Baseline|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
791385|NCT01436162|B1|Baseline|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose) for 8 weeks.
791386|NCT01436162|P3|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
791387|NCT01436162|P2|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among a 20, 30, 50, or 70 mg dose).
791388|NCT01436162|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
791389|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
791390|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791391|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791392|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791393|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791394|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791395|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791396|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791397|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791398|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791399|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791400|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791401|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791402|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791540|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791403|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791404|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791405|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791406|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791407|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791408|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791409|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791410|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791411|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791412|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791413|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791414|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791415|NCT01436162|O2|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791416|NCT01436162|O1|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791417|NCT01436162|E2|Reported Event|Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
791418|NCT01436162|E1|Reported Event|SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate ): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
791419|NCT01436149|B3|Baseline|Total|Total of all reporting groups
791420|NCT01436149|B2|Baseline|Antidepressant + Double-blind SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose) for 8 weeks.
791421|NCT01436149|B1|Baseline|Antidepressant + Double-blind Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489) for 8 weeks.
791422|NCT01436149|P3|Participant Flow|Antidepressant + Double-blind SPD489|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50, or 70 mg dose).
791423|NCT01436149|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received assigned oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
791424|NCT01436149|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded oral, once daily standard antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended-release, or duloxetine hydrochloride) plus oral, once daily placebo (matching SPD489).
791425|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
792021|NCT01433250|P1|Participant Flow|AIN457 Core / AIN457 Extension|AIN in core study , continued AIN in extension study ( 10 mg/Kg iv every four weeks)
791426|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791427|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791428|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791429|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791430|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791431|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791432|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791433|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791434|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791435|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791436|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791437|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791438|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791439|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791440|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791441|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791442|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791443|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791444|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791445|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791446|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
791447|NCT01436149|O2|Outcome|Antidepressant + SPD489|Antidepressant + SPD489 (Lisdexamfetamine dimesylate): Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + SPD489 (optimized as a 20, 30, 50, or 70 mg dose, oral, once daily), for 8 weeks.
791448|NCT01436149|O1|Outcome|Antidepressant + Placebo|Antidepressant + Placebo: Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks.
829677|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
791449|NCT01436149|E2|Reported Event|Antidepressant + SPD489|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride), plus oral, once daily SPD489 (Lisdexamfetamine dimesylate optimized among 20, 30, 50 or 70 mg dose).
791450|NCT01436149|E1|Reported Event|Antidepressant + Placebo|Oral, once daily antidepressant therapy (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release, or duloxetine hydrochloride) plus oral, once daily, double-blind placebo (matching SPD489).
791451|NCT01436110|B4|Baseline|Total|Total of all reporting groups
791452|NCT01436110|B3|Baseline|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791453|NCT01436110|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791454|NCT01436110|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791455|NCT01436110|P3|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791456|NCT01436110|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791457|NCT01436110|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791458|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791459|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791460|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791461|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791462|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791463|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791464|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791465|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791466|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791467|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791468|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791469|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791470|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791471|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791472|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791473|NCT01436110|O3|Outcome|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791474|NCT01436110|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791475|NCT01436110|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791476|NCT01436110|E3|Reported Event|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID via a DPI plus placebo via a different DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791477|NCT01436110|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening plus placebo via a different DPI BID for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791478|NCT01436110|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening plus placebo via a different DPI twice daily (BID) for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791479|NCT01436084|B1|Baseline|SB1518|400 mg orally a day for 28 day cycle.
791480|NCT01436084|P1|Participant Flow|SB1518|400 mg orally a day for 28 day cycle.
791481|NCT01436084|O1|Outcome|SB1518|400 mg orally a day for 28 day cycle.
791482|NCT01436084|E1|Reported Event|SB1518|400 mg orally a day for 28 day cycle.
791483|NCT01436071|B3|Baseline|Total|Total of all reporting groups
791484|NCT01436071|B2|Baseline|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791485|NCT01436071|B1|Baseline|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791486|NCT01436071|P2|Participant Flow|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791487|NCT01436071|P1|Participant Flow|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791488|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791489|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791490|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791491|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791492|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791493|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791494|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791495|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791496|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791497|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791498|NCT01436071|O2|Outcome|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791499|NCT01436071|O1|Outcome|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791500|NCT01436071|E2|Reported Event|FF 50 µg OD|Participants received fluticasone furoate (FF) 50 micrograms (µg) inhalation powder via a DPI OD in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792022|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
791501|NCT01436071|E1|Reported Event|Placebo|Participants receieved placebo via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 12 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
791502|NCT01436045|B1|Baseline|All Study Partipants|Participants who received either intranasal glulisine (0.10 milliliter (mL) in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
791503|NCT01436045|P2|Participant Flow|Placebo, Then Insulin Glulisine|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Placebo (5 minutes), Washout (1 week), Insulin Glulisine (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
791504|NCT01436045|P1|Participant Flow|Insulin Glulisine, Then Placebo|"A randomized, double-blind, placebo-controlled, cross-over designed - all subject will receive intervention (insulin glulisine) and placebo (saline) during separate visits.~Insulin glulisine (5 minutes), Washout (1 week), Placebo (5 minutes)~Insulin glulisine: Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)~Placebo: Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)"
791505|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
791506|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
791507|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
791508|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
791509|NCT01436045|O2|Outcome|Post Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
791510|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
791511|NCT01436045|O2|Outcome|Post-Placebo|Results of cognitive assessment after intranasal treatment with Placebo.
791512|NCT01436045|O1|Outcome|Post-Insulin Glulisine|Results of cognitive assessment after intranasal treatment with Insulin Glulisine.
791513|NCT01436045|E1|Reported Event|All Study Partipants|Participants who received either intranasal glulisine (0.10 mL in each nostril, 20 IU total) or placebo (0.10 mL in each nostril) at the 2nd or 3rd study visit.
791514|NCT01436006|B1|Baseline|CT Scan|patient with cancer
791515|NCT01436006|P1|Participant Flow|CT Scan|"A total of 65 radiology departments, with 70 MDCT scanners, collected data of 5942 adult patients, randomly chosen, who underwent to CT examinations for common clinical for 5 common different protocols including also new examination that will be in the near future common practise as cardiac CT.~A prevalence of multiphasic study was documented in many chest abdomen and pelvis (CAP) studies and abdominal studies."
791516|NCT01436006|O1|Outcome|CT Adult Spine|Adult patients submitted to spine CT
791517|NCT01436006|O1|Outcome|Adult Patient Chest Abdomen and Pelvis|Adult patients submitted to chest abdomen and pelvis CT examinations.
791518|NCT01436006|O1|Outcome|Adult Cardiac CT|Adult patients submitted to cardiac CT
791519|NCT01436006|O2|Outcome|Abdomen CT Pediatric|Pediatric patients submitted to abdomen CT
791520|NCT01436006|O1|Outcome|Abdomen CT Adults|Adult patients submitted to abdomen CT
791521|NCT01436006|O2|Outcome|Chest CT- Pediatric|Pediatric patients submitted to chest CT
791522|NCT01436006|O1|Outcome|Chest CT- Adult|Adult patients submitted to chest CT
791523|NCT01436006|O2|Outcome|Pediatric|Pediatric patients submitted to head CT scan
791524|NCT01436006|O1|Outcome|Adult|Adult patients submitted to head CT scan
791525|NCT01436006|E1|Reported Event|Adverse Reaction to CT|Patients submitted to CT
791526|NCT01435928|B3|Baseline|Total|Total of all reporting groups
791527|NCT01435928|B2|Baseline|Placebo|During double blind phase subjects received matching placebo.
791528|NCT01435928|B1|Baseline|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
791529|NCT01435928|P3|Participant Flow|Placebo|During double blind phase subjects received matching placebo.
791530|NCT01435928|P2|Participant Flow|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
791531|NCT01435928|P1|Participant Flow|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
791532|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791533|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791534|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791535|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791536|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791537|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791538|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791539|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791653|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791541|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791542|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791543|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791544|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791545|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791546|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791547|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791548|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791549|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791550|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791551|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791552|NCT01435928|O2|Outcome|Placebo|"Matching placebo once daily in the evening with a meal or 30 minutes after eating~Matching Placebo: Matching placebo once daily in the evening with a meal or 30 minutes after eating"
791553|NCT01435928|O1|Outcome|Lurasidone|"Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating~Lurasidone: Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating"
791554|NCT01435928|E3|Reported Event|Placebo|During double blind phase subjects received matching placebo.
791555|NCT01435928|E2|Reported Event|Lurasidone|During double blind phase subjects received Lurasidone flexibly dosed 40 or 80 mg once daily
791556|NCT01435928|E1|Reported Event|All Subjects|During the Open Label Phase subjects will receive Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
791557|NCT01435798|B1|Baseline|Dextromethorphan Dose Response Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
791558|NCT01435798|P1|Participant Flow|Dextromethorphan Dose Response (DDR) Clinical Trial|Each subject received four doses of dextromethorphan; 0% (placebo), 25%, 50%, and 100% of the maximum tolerated dose in a balanced randomized order. Each dose was administered for a period of 28 days; on day 21 of each phase, subjects traveled to the study site to undergo study procedures in a nested clinical trial (not described here).
791559|NCT01435798|O4|Outcome|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791560|NCT01435798|O3|Outcome|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791561|NCT01435798|O2|Outcome|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791562|NCT01435798|O1|Outcome|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791563|NCT01435798|O4|Outcome|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791564|NCT01435798|O3|Outcome|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791565|NCT01435798|O2|Outcome|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791566|NCT01435798|O1|Outcome|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791567|NCT01435798|E4|Reported Event|100% MTD Dex|100% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791568|NCT01435798|E3|Reported Event|50% MTD Dex|50% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791569|NCT01435798|E2|Reported Event|25% MTD Dex|25% of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791570|NCT01435798|E1|Reported Event|0% MTD Dex|0% (placebo) of maximum tolerated dose of dextromethorphan; dose was administered for a period of 28 days, and on day 21, subjects traveled to the study site to undergo additional study procedures.
791571|NCT01435759|B6|Baseline|Total|Total of all reporting groups
791572|NCT01435759|B5|Baseline|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
791573|NCT01435759|B4|Baseline|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
791574|NCT01435759|B3|Baseline|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
791575|NCT01435759|B2|Baseline|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
791576|NCT01435759|B1|Baseline|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
791577|NCT01435759|P6|Participant Flow|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
791578|NCT01435759|P5|Participant Flow|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
791579|NCT01435759|P4|Participant Flow|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
791580|NCT01435759|P3|Participant Flow|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
791581|NCT01435759|P2|Participant Flow|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
791582|NCT01435759|P1|Participant Flow|Antidepressant + Single-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily single-blind placebo (matching SPD489).
791583|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
791584|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
791585|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
791586|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
791587|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
791588|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
791589|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
791590|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
791591|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
791592|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
791593|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
791594|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
792023|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
791595|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
791596|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
791597|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
791598|NCT01435759|O5|Outcome|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
791599|NCT01435759|O4|Outcome|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
791600|NCT01435759|O3|Outcome|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
791601|NCT01435759|O2|Outcome|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
791602|NCT01435759|O1|Outcome|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
791603|NCT01435759|E5|Reported Event|Antidepressant + Double-blind SPD489 70mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 70mg dose.
791604|NCT01435759|E4|Reported Event|Antidepressant + Double-blind SPD489 50mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 50mg dose.
791605|NCT01435759|E3|Reported Event|Antidepressant + Double-blind SPD489 30mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 30mg dose.
791606|NCT01435759|E2|Reported Event|Antidepressant + Double-blind SPD489 10mg|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily over-encapsulated SPD489 as a 10mg dose.
791607|NCT01435759|E1|Reported Event|Antidepressant + Double-blind Placebo|Subjects received unblinded standard antidepressant therapy (either escitalopram oxalate or venlafaxine hydrochloride extended-release titrated to the maximum tolerated dose) plus oral, once daily double-blind placebo (matching SPD489).
791608|NCT01435655|B1|Baseline|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791609|NCT01435655|P1|Participant Flow|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791610|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791611|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791612|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791613|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791614|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791615|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791616|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791617|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791618|NCT01435655|O1|Outcome|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791619|NCT01435655|E1|Reported Event|Tafamidis 20 mg|Participants (V30m and non-V30m transthyretin mutation) received tafamidis 20 mg soft gelatin capsules orally once daily for up to 78 weeks
791620|NCT01435577|B3|Baseline|Total|Total of all reporting groups
791621|NCT01435577|B2|Baseline|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791622|NCT01435577|B1|Baseline|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791654|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
792024|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
791623|NCT01435577|P2|Participant Flow|Matching Placebo Intravenous|"Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.~65 Randomized participants, 65 Participants in the Safety Set (SAF), 65 Participants in the Full Analysis Set(FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
791624|NCT01435577|P1|Participant Flow|Tapentadol Intravenous|"Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.~64 Participants Randomized, 64 Participants in the Safety Set (SAF), 64 Participants in the Full Analysis Set (FAS). The FAS comprised all randomized subjects who were administered at least 1 dose and had a baseline pain assessment."
791625|NCT01435577|O1|Outcome|Matching Placebo Intravenous|Matching Placebo will be given by intravenous infusion. Matching Placebo will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791626|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791627|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
791628|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791629|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791630|NCT01435577|O1|Outcome|Tapentadol Intravenous|Pharmacokinetic samples were taken from all participants, however only samples from the tapentadol treatment group were analyzed.
791631|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone. Values collected after 12 hours were censored, i.e. participants scored as having no meaningful pain relief.
791632|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791633|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791634|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791635|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791636|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791637|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791638|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791639|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791640|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791641|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791642|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791643|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791644|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791645|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791646|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791647|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791648|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791649|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791650|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791651|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791652|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791655|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791656|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791657|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791658|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791659|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791660|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791661|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791662|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791663|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791664|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791665|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791666|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791667|NCT01435577|O2|Outcome|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791668|NCT01435577|O1|Outcome|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by tapentadol alone.
791669|NCT01435577|E2|Reported Event|Matching Placebo Intravenous|Placebo (0.9% sodium chloride and water for injection). Ibuprofen 600 mg orally may be given as rescue medication for pain.
791670|NCT01435577|E1|Reported Event|Tapentadol Intravenous|Tapentadol will be given by intravenous infusion. Tapentadol will be administered every 4 hours. Ibuprofen 600 mg orally may be given as rescue medication for pain not controlled by Tapentadol alone.
791671|NCT01435460|B3|Baseline|Total|Total of all reporting groups
791672|NCT01435460|B2|Baseline|Patanol|Ophthalmic solution containing olopatadine, 0.1%
791673|NCT01435460|B1|Baseline|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
791674|NCT01435460|P2|Participant Flow|Patanol|Ophthalmic solution containing olopatadine, 0.1%
791675|NCT01435460|P1|Participant Flow|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
791676|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
791677|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
791678|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
791679|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
791680|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
791681|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
791682|NCT01435460|O2|Outcome|Patanol|Ophthalmic solution containing olopatadine, 0.1%
791683|NCT01435460|O1|Outcome|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
791684|NCT01435460|E2|Reported Event|Patanol|Ophthalmic solution containing olopatadine, 0.1%
791685|NCT01435460|E1|Reported Event|Alrex|Ophthalmic formulation containing the active ingredient loteprednol etabonate, 0.2%
791686|NCT01435265|B3|Baseline|Total|Total of all reporting groups
791687|NCT01435265|B2|Baseline|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
791688|NCT01435265|B1|Baseline|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
791689|NCT01435265|P2|Participant Flow|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
791690|NCT01435265|P1|Participant Flow|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
791691|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
791692|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
791693|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
791694|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
791695|NCT01435265|O2|Outcome|Additional Nurse Education-|Subjects will receive additional nurse education beyond the normal education materials provided by their physician
791696|NCT01435265|O1|Outcome|Normal Nurse Education|Subjects receive normal nurse education materials provided by their physician.
791697|NCT01435265|E2|Reported Event|Additional Nurse Education|Experimental: Additional Nurse Education- Subjects will receive additional nurse education beyond the normal education materials provided by their physician
791699|NCT01435174|B1|Baseline|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
791700|NCT01435174|P1|Participant Flow|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
791701|NCT01435174|O1|Outcome|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
791702|NCT01435174|E1|Reported Event|Ranolazine|"End-stage renal disease patients receiving a single-dose of ranolazine and a concomitant hemodialysis session.~Ranolazine: A single dose of two oral ranolazine extended release 500 mg tablets~Pharmacokinetic Blood and Dialysate Sampling: Blood samples collected to assess ranolazine plasma and dialysate concentrations.~QT Interval: Calculation of a QT interval will be performed throughout subject participation."
791703|NCT01435122|B1|Baseline|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791704|NCT01435122|P1|Participant Flow|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791705|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791706|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791707|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791708|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791709|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791710|NCT01435122|O1|Outcome|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791711|NCT01435122|E1|Reported Event|Axitinib Administration|The investigational drug used in this study is axitinib, and is available as tablets.
791712|NCT01435031|B1|Baseline|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791713|NCT01435031|P1|Participant Flow|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791714|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791715|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791716|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791717|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791718|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791719|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791720|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791721|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791722|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791723|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791724|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791725|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791726|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791727|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791728|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791729|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791730|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791837|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
791731|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791732|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791733|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791734|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791735|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791736|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791737|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791738|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791739|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791740|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791741|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791742|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791838|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
830417|NCT01291056|O2|Outcome|Placebo|Placebo
791743|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791744|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791745|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791746|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791747|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791748|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791749|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791750|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791751|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791752|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791753|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791754|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791839|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
791755|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791756|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791757|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791758|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791759|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791760|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791761|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791762|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791763|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791764|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791765|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791766|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791840|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
791767|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791768|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791769|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791770|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791771|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791772|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791773|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791774|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791775|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791776|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791777|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791778|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791841|NCT01434680|O1|Outcome|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
830634|NCT01290640|B1|Baseline|PFC RP TC3 TKA|
791779|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791780|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791781|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791782|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791783|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791784|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791785|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791786|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791787|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791788|NCT01435031|O1|Outcome|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791789|NCT01435031|E1|Reported Event|CTO Treatment|"Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation~CTO Treatment Device: Subjects receiving at least 1 of the following for the treatment of CTO:~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent~HT PROGRESS and/or HT PILOT guide wires in recanalization~MINI-TREK Coronary Dilatation Catheter in predilatation"
791790|NCT01434823|B3|Baseline|Total|Total of all reporting groups
791791|NCT01434823|B2|Baseline|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
791792|NCT01434823|B1|Baseline|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
791842|NCT01434680|E4|Reported Event|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
791793|NCT01434823|P2|Participant Flow|Control - Standard of Care|"The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay."
791794|NCT01434823|P1|Participant Flow|Intervention - Nocturnal Coverage|"Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.~Randomization was blocked such that 1 week of a 2-week attending block of service was randomized to nocturnal coverage. We also calculated the proportion of covered nights for each patient's ICU stay in secondary analyses."
791795|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
791796|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
791797|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
791798|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
791799|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
791800|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
791801|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
791802|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
791803|NCT01434823|O2|Outcome|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
791804|NCT01434823|O1|Outcome|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
791805|NCT01434823|E2|Reported Event|Control - Standard of Care|The weeks that are not randomized, the intervention arm will retain the current standard of care in the HUP MICU: attending intensivist availability by phone (home call).
791806|NCT01434823|E1|Reported Event|Intervention - Nocturnal Coverage|Nocturnal coverage from intensivists will be randomized by week. The weeks that have intensivists in the MICU during the 7pm to 7am shift are the intervention weeks.
791807|NCT01434693|B5|Baseline|Total|Total of all reporting groups
791808|NCT01434693|B4|Baseline|TSO 7500|Trichuris suis ova : single dose
791809|NCT01434693|B3|Baseline|TSO 2500|Trichuris suis ova : single dose
791810|NCT01434693|B2|Baseline|TSO 500|Trichuris suis ova : single dose
791811|NCT01434693|B1|Baseline|Placebo|Placebo: single dose
791812|NCT01434693|P4|Participant Flow|TSO 7500|Trichuris suis ova : single dose
791813|NCT01434693|P3|Participant Flow|TSO 2500|Trichuris suis ova : single dose
791814|NCT01434693|P2|Participant Flow|TSO 500|Trichuris suis ova : single dose
791815|NCT01434693|P1|Participant Flow|Placebo|Placebo: single dose
791816|NCT01434693|O4|Outcome|TSO 7500|Trichuris suis ova : single dose
791817|NCT01434693|O3|Outcome|TSO 2500|Trichuris suis ova : single dose
791818|NCT01434693|O2|Outcome|TSO 500|Trichuris suis ova : single dose
791819|NCT01434693|O1|Outcome|Placebo|Placebo: single dose
791820|NCT01434693|E4|Reported Event|TSO 7500|Trichuris suis ova : single dose
791821|NCT01434693|E3|Reported Event|TSO 2500|Trichuris suis ova : single dose
791822|NCT01434693|E2|Reported Event|TSO 500|Trichuris suis ova : single dose
791823|NCT01434693|E1|Reported Event|Placebo|Placebo: single dose
791824|NCT01434680|B5|Baseline|Total|Total of all reporting groups
791825|NCT01434680|B4|Baseline|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
791826|NCT01434680|B3|Baseline|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
791827|NCT01434680|B2|Baseline|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
791828|NCT01434680|B1|Baseline|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
791829|NCT01434680|P4|Participant Flow|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
791830|NCT01434680|P3|Participant Flow|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
791831|NCT01434680|P2|Participant Flow|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
791832|NCT01434680|P1|Participant Flow|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
791833|NCT01434680|O4|Outcome|MenC-CRM ROS_EMV|Subjects enrolled to receive MenC-CRM ROS, but were mistakenly administered 1 injection of MenC-CRM EMV
791834|NCT01434680|O3|Outcome|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
791835|NCT01434680|O2|Outcome|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
791843|NCT01434680|E3|Reported Event|MenC-CRM EMV|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
791844|NCT01434680|E2|Reported Event|MenC-CRM ROS|Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
791845|NCT01434680|E1|Reported Event|MenC-CRM LIQ|Subjects received 1 injection of MenC-CRM vaccine, liquid formulation.
791846|NCT01434654|B3|Baseline|Total|Total of all reporting groups
791847|NCT01434654|B2|Baseline|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791848|NCT01434654|B1|Baseline|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791849|NCT01434654|P2|Participant Flow|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791850|NCT01434654|P1|Participant Flow|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791851|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791852|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791853|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791854|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791855|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791856|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791857|NCT01434654|O2|Outcome|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791858|NCT01434654|O1|Outcome|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are allocated to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791859|NCT01434654|E2|Reported Event|Neuro-HAART (High CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791860|NCT01434654|E1|Reported Event|Non Neuro-HAART (Low CNS Penetrance)|Participants will be assessed based on their current Highly Active Antiretroviral Treatment (HAART). A scoring system is utilised to determine if their current treatment has high Central Nervous System (CNS) penetrance or low CNS penetrance. This will determine which study cohort they are randomised to. No treatment adjustments or changes will be made, they will remain on their usual HAART regimen.
791861|NCT01434641|B1|Baseline|Myocardial Perfusion SPECT|The 102 study patients underwent a very low-activity stress/high-activity rest, single-day myocardial perfusion SPECT ith a conventional sodium iodide camera and wide beam reconstruction processing.
792025|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
791862|NCT01434641|P1|Participant Flow|Stress/Rest Myocardial Perfusion SPECT Patients|All patients referred for clinically indicated myocardial perfusion SPECT are eligible candidates for this protocol. Low-dose stress/high-dose rest myocardial perfusion SPECT is performed according to the protocol and image quality and rest/stress myocardial count density ratios are assessed.
791863|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
791864|NCT01434641|O1|Outcome|Myocardial Perfusion SPECT|Participants underwent novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
791865|NCT01434641|E1|Reported Event|Myocardial Perfusion SPECT|
791866|NCT01434511|B1|Baseline|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791867|NCT01434511|P1|Participant Flow|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791868|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791869|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791870|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791871|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791872|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791873|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791874|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791875|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791876|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791877|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791878|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791879|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791880|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791881|NCT01434511|O1|Outcome|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791882|NCT01434511|E1|Reported Event|OBI-1|OBI-1: intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
791883|NCT01434342|B3|Baseline|Total|Total of all reporting groups
791884|NCT01434342|B2|Baseline|Arm II|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
791885|NCT01434342|B1|Baseline|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
791886|NCT01434342|P2|Participant Flow|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
791887|NCT01434342|P1|Participant Flow|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
791888|NCT01434342|O2|Outcome|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
791889|NCT01434342|O1|Outcome|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.~The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.~Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.~Participants also learn behavioral tips and coping skills."
792026|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
792027|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
837357|NCT01270529|B4|Baseline|Total|Total of all reporting groups
791890|NCT01434342|O2|Outcome|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
791891|NCT01434342|O1|Outcome|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff.~The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients.~Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period.~Participants also learn behavioral tips and coping skills."
791892|NCT01434342|E2|Reported Event|Arm II - Usual Care|Participants receive a letter from their physician advising them to quit smoking, the importance of quitting smoking for cancer patients, and a copy of the National Cancer Institute’s “Clearing the Air” smoking cessation booklet. Participants also receive standard of care from their oncology and other treatment providers which may or may not include nicotine replacement therapy.
791893|NCT01434342|E1|Reported Event|Arm I - Quitline|"Participants receive a letter from their physician advising them to quit smoking, and undergo a 15-30-minute smoking-cessation counseling session by a trained research staff. The participants are educated and motivated about the importance of quitting smoking, and cancer-specific quitting issues. They will be called by Quitline in 2-3 days and receive a fact sheet about benefits of SC for cancer patients. Participants receive 8 weeks of nicotine replacement patches and up to 5 proactive telephone calls over a 12-week period. Participants also learn behavioral tips and coping skills.~Nicotine Replacement Patch: Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 we"
791894|NCT01434186|B3|Baseline|Total|Total of all reporting groups
791895|NCT01434186|B2|Baseline|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
791896|NCT01434186|B1|Baseline|Placebo|Placebo matching saxagliptin
791897|NCT01434186|P2|Participant Flow|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
791898|NCT01434186|P1|Participant Flow|Placebo|Placebo matching saxagliptin
791899|NCT01434186|O2|Outcome|Placebo|Saxagliptin matching placebo
791900|NCT01434186|O1|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg according to bodyweight
791901|NCT01434186|E2|Reported Event|Saxagliptin|saxagliptin 2.5 or 5 mg according to body weight
791902|NCT01434186|E1|Reported Event|Placebo|Placebo matching saxagliptin
791903|NCT01434121|B4|Baseline|Total|Total of all reporting groups
791904|NCT01434121|B3|Baseline|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791905|NCT01434121|B2|Baseline|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791906|NCT01434121|B1|Baseline|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791907|NCT01434121|P3|Participant Flow|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791908|NCT01434121|P2|Participant Flow|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791909|NCT01434121|P1|Participant Flow|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791910|NCT01434121|O3|Outcome|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791911|NCT01434121|O2|Outcome|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791912|NCT01434121|O1|Outcome|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791913|NCT01434121|E3|Reported Event|Placebo|"Subject receives an infusion of saline~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791914|NCT01434121|E2|Reported Event|Low Dose Ascorbic Acid|"Subject receives a low dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791915|NCT01434121|E1|Reported Event|High Dose Ascorbic Acid|"Subject receives a high dose of infused Vitamin C~Ascorbic Acid vs. Placebo: The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo"
791916|NCT01434030|B1|Baseline|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
791946|NCT01433549|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A worn first, with lotrafilcon B worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
792028|NCT01433250|O2|Outcome|PBO/AIN|placebo first 24 weeks/ AIN extension for 52 weeks
792029|NCT01433250|O1|Outcome|AIN/AIN|AIN core 24 weeks/AIN extension 1 year
791917|NCT01434030|P1|Participant Flow|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
791918|NCT01434030|O1|Outcome|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
791919|NCT01434030|O1|Outcome|Behavioral Observer|Focus group methodology was chosen to obtain qualitative and quantitative data on participants’ desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
791920|NCT01434030|E1|Reported Event|Behavioral Observer|Behavioral: This is a field study that will investigate behavioral events (e.g. meals, exercise) in T1DM and daily glucose patterns using an insulin pump, continuous glucose monitoring (CGM) data, and frequent SMBG tagged with behavioral markers (recent food and activity). From these data, a learning algorithm – behavioral observer - will be able to track over time key recurrent elements, such as wake-up time, meals, exercise, and daily patterns of risks for hypo- or hyperglycemia. In future controllers, behavioral observation such as this will be used to forecast upcoming routine events, enabling open-loop and closed-loop control algorithms to deal with the probabilistic patterns of patients’ self-treatment behavior.
791921|NCT01433913|B3|Baseline|Total|Total of all reporting groups
791922|NCT01433913|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
791923|NCT01433913|B1|Baseline|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
791924|NCT01433913|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
791925|NCT01433913|P1|Participant Flow|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
791926|NCT01433913|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
791927|NCT01433913|O1|Outcome|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
791928|NCT01433913|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 4-12 weeks.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
791929|NCT01433913|E1|Reported Event|Arm I (Metformin Hydrochloride)|"Patients receive extended-release metformin hydrochloride PO QD for 4-12 weeks.~metformin hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
791930|NCT01433731|B5|Baseline|Total|Total of all reporting groups
791931|NCT01433731|B4|Baseline|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
791932|NCT01433731|B3|Baseline|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
791933|NCT01433731|B2|Baseline|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
791934|NCT01433731|B1|Baseline|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
791935|NCT01433731|P4|Participant Flow|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
791936|NCT01433731|P3|Participant Flow|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
791937|NCT01433731|P2|Participant Flow|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
791938|NCT01433731|P1|Participant Flow|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
791939|NCT01433731|O2|Outcome|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gel
791940|NCT01433731|O1|Outcome|SHAPE (SHP-141)|"Histone deacetylase inhibitor~SHAPE (SHP-141): topical gel"
791941|NCT01433731|E4|Reported Event|SHAPE (SHP-141) 1.0% BID|SHAPE (SHP-141): topical gelled solution at 1.0% concentration twice daily
791942|NCT01433731|E3|Reported Event|SHAPE (SHP-141) 0.5% BID|SHAPE (SHP-141): topical gelled solution at 0.5% concentration twice daily
791943|NCT01433731|E2|Reported Event|SHAPE (SHP-141) 0.1% BID|SHAPE (SHP-141): topical gelled solution at 0.1% concentration twice daily
791944|NCT01433731|E1|Reported Event|Placebo for SHAPE (SHP-141)|placebo for SHAPE (SHP-141): topical gelled solution
791945|NCT01433549|B1|Baseline|Overall|Lotrafilcon B and Senofilcon A worn in cross-over fashion as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791987|NCT01433263|B3|Baseline|Total|Total of all reporting groups
791947|NCT01433549|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B worn first, with senofilcon A worn second, as randomized. Each product was worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791948|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791949|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791950|NCT01433549|O2|Outcome|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791951|NCT01433549|O1|Outcome|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791952|NCT01433549|E2|Reported Event|Senofilcon A|Senofilcon A worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791953|NCT01433549|E1|Reported Event|Lotrafilcon B|Lotrafilcon B worn worn bilaterally in 2-hour intervals, separated by lens-free (recovery) intervals of either 0, 30, 60, or 80 minutes, over the course of a 12-hour day, for a total of 4 cycles (days).
791954|NCT01433471|B3|Baseline|Total|Total of all reporting groups
791955|NCT01433471|B2|Baseline|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791956|NCT01433471|B1|Baseline|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791957|NCT01433471|P2|Participant Flow|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791958|NCT01433471|P1|Participant Flow|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791959|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791960|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791961|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791962|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791963|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791964|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791965|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791966|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791967|NCT01433471|O2|Outcome|Placebo Followed by Trichuris Suis Ova|"Subjects in this arm will receive placebo for 12 weeks, followed by Trichuris suis ova for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791968|NCT01433471|O1|Outcome|Trichuris Suis Ova Followed by Placebo|"Subjects in this arm will receive Trichuris suis ova for 12 weeks, followed by placebo for 12 weeks after crossover~Trichuris suis ova: 2,500 eggs by mouth every two weeks for 12 weeks"
791969|NCT01433471|O2|Outcome|Placebo|
791970|NCT01433471|O1|Outcome|Trichuris Suis Ova|
791971|NCT01433471|E2|Reported Event|Placebo|
791972|NCT01433471|E1|Reported Event|Trichuris Suis Ova|
791973|NCT01433354|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
791974|NCT01433354|P1|Participant Flow|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals.
791975|NCT01433354|O6|Outcome|AFQ056 100 mg Bid|
791976|NCT01433354|O5|Outcome|AFQ056 75 mg Bid|
791977|NCT01433354|O4|Outcome|AFQ056 50 mg Bid|
791978|NCT01433354|O3|Outcome|AFQ056 25 mg Bid|
791979|NCT01433354|O2|Outcome|Prior to Ext. First Dose|
791980|NCT01433354|O1|Outcome|AFQ056|Total
791981|NCT01433354|E6|Reported Event|Total|Total
791982|NCT01433354|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
791983|NCT01433354|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
791984|NCT01433354|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
791985|NCT01433354|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
791986|NCT01433354|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
792035|NCT01433250|E1|Reported Event|Placebo(Core)/AIN457(Extension)|Placebo(core)/AIN457(extension)
792036|NCT01433172|B4|Baseline|Total|Total of all reporting groups
792037|NCT01433172|B3|Baseline|Phase II Arm B Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
792038|NCT01433172|B2|Baseline|Phase II Arm A Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
792039|NCT01433172|B1|Baseline|Phase I Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
792040|NCT01433172|P3|Participant Flow|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Phase II Arm B: Participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
792041|NCT01433172|P2|Participant Flow|Phase II Arm A GM.CD40L Cells Vaccinations|Phase II Arm A: Participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
792042|NCT01433172|P1|Participant Flow|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period.
792043|NCT01433172|O2|Outcome|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
792044|NCT01433172|O1|Outcome|Phase II Arm A GM.CD40L Cells Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
792045|NCT01433172|O2|Outcome|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
792046|NCT01433172|O1|Outcome|Phase II Arm A GM.CD40L Cells Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
792047|NCT01433172|O1|Outcome|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
792048|NCT01433172|E3|Reported Event|Phase II Arm B GM.CD40L.CCL21 Vaccinations|Arm B participants will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
792049|NCT01433172|E2|Reported Event|Phase II Arm A GM.CD40L Vaccinations|Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals.
792050|NCT01433172|E1|Reported Event|Phase I GM.CD40L.CCL21 Vaccinations|Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals.
792051|NCT01433159|B3|Baseline|Total|Total of all reporting groups
792052|NCT01433159|B2|Baseline|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
792053|NCT01433159|B1|Baseline|HP011-101|Xenaderm Ointment
792054|NCT01433159|P2|Participant Flow|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
792055|NCT01433159|P1|Participant Flow|HP011-101|Xenaderm Ointment
792056|NCT01433159|O2|Outcome|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT-containing products
792057|NCT01433159|O1|Outcome|HP011-101|Xenaderm Ointment
792058|NCT01433159|E2|Reported Event|Various Standard Care|Standard Care at each site other than Xenaderm Ointment or other BCT2-containing products
792059|NCT01433159|E1|Reported Event|HP011-101|Xenaderm Ointment
792060|NCT01433107|B3|Baseline|Total|Total of all reporting groups
792061|NCT01433107|B2|Baseline|Placebo|Drug
792062|NCT01433107|B1|Baseline|Terbinafine|Drug
792063|NCT01433107|P2|Participant Flow|Placebo|Drug
792064|NCT01433107|P1|Participant Flow|Terbinafine|Drug
792065|NCT01433107|O2|Outcome|Placebo|Drug
792066|NCT01433107|O1|Outcome|Terbinafine|Drug
792067|NCT01433107|O2|Outcome|Placebo|Drug
792068|NCT01433107|O1|Outcome|Terbinafine|Drug
792069|NCT01433107|O2|Outcome|Placebo|Drug
792070|NCT01433107|O1|Outcome|Terbinafine|Drug
792071|NCT01433107|E2|Reported Event|Placebo|Drug
792072|NCT01433107|E1|Reported Event|Terbinafine|Drug
792073|NCT01433081|B3|Baseline|Total|Total of all reporting groups
792074|NCT01433081|B2|Baseline|Placebo|.9 normal saline infusion
792075|NCT01433081|B1|Baseline|Magnesium Sulfate Infusion|Administration of magnesium suflate
792076|NCT01433081|P2|Participant Flow|Placebo|Normal saline infusion
792077|NCT01433081|P1|Participant Flow|Magnesium Sulfate Infusion|Administration of magnesium suflate
792078|NCT01433081|O2|Outcome|Placebo|.9 normal saline infusion
792079|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
792080|NCT01433081|O2|Outcome|Placebo|Normal saline infusion
792081|NCT01433081|O1|Outcome|Magnesium Sulfate Infusion|Administration of magnesium suflate
792082|NCT01433081|E2|Reported Event|Placebo|.9 normal saline infusion
792083|NCT01433081|E1|Reported Event|Magnesium Sulfate Infusion|Administration of magnesium suflate
792084|NCT01433055|B3|Baseline|Total|Total of all reporting groups
792085|NCT01433055|B2|Baseline|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792140|NCT01432756|B1|Baseline|Wait-list Control - Parent Participants|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
792086|NCT01433055|B1|Baseline|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792087|NCT01433055|P2|Participant Flow|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792088|NCT01433055|P1|Participant Flow|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792089|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792090|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792091|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792092|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792093|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792094|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792112|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
792113|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
792095|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792096|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792097|NCT01433055|O2|Outcome|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792098|NCT01433055|O1|Outcome|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792099|NCT01433055|E2|Reported Event|Sugar Pill|"Placebo: Placebo Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792100|NCT01433055|E1|Reported Event|Minocycline|"Minocycline: Minocycline Dosing:~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
792101|NCT01433042|B1|Baseline|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
792102|NCT01433042|P1|Participant Flow|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
792103|NCT01433042|O1|Outcome|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
792104|NCT01433042|E1|Reported Event|Capsule Endoscopy|capsule endoscopy : capsule endoscopy procedure
792105|NCT01433016|B1|Baseline|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
792106|NCT01433016|P1|Participant Flow|Suspected HCC|Subjects at high risk for hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease will be asked to perform a single Octanoate Breath test, where their breath will be analyzed before and after ingestion of 100 milligrams of Octanoate dissolved in a cup of tap water. The actual breath test procedure lasts approximately one hour.
792107|NCT01433016|O1|Outcome|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
792108|NCT01433016|E1|Reported Event|Suspected HCC|Subjects at high risk for Hepatocellular carcinoma (HCC), such as cirrhotics and patients with advanced liver disease
792109|NCT01432938|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (dulaglutide or warfarin).
792110|NCT01432938|P2|Participant Flow|Dulaglutide + Warfarin First, Then Warfarin|"First Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2).~There was a washout period of at least 24 days between intervention periods.~Second Intervention: A single, 10-mg dose of warfarin administered orally on Day 1 (Treatment 1)."
792111|NCT01432938|P1|Participant Flow|Warfarin First, Then Dulaglutide + Warfarin|"First Intervention: A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 (Treatment 1).~There was a washout period of at least 24 days between treatment periods.~Second Intervention: A single, 1.5-mg subcutaneous dose of dulaglutide on Day 1, followed by a single, 10-mg dose of warfarin administered orally on Day 3 (Treatment 2)."
838735|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
792114|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
792115|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
792116|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
792117|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
792118|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
792119|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
792120|NCT01432938|O2|Outcome|Dulaglutide + Warfarin|A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2.
792121|NCT01432938|O1|Outcome|Warfarin Alone|A single, 10-milligram (mg) dose of warfarin administered orally on Day 1 of Treatment 1.
792122|NCT01432938|E3|Reported Event|Dulaglutide + Warfarin|"A single, 1.5-mg dose of dulaglutide administered subcutaneously on Day 1 of Treatment 2, followed by a single, 10-mg dose of warfarin administered orally on Day 3 of Treatment 2~Timeframe: After dosing of warfarin on Day 3 of Treatment 2"
792123|NCT01432938|E2|Reported Event|Dulaglutide Alone|"A single, 1.5-mg dose administered subcutaneously on Day 1 of Treatment 2.~Timeframe: Day 1 to Day 3 before dosing of warfarin in Treatment 2"
792124|NCT01432938|E1|Reported Event|Warfarin Alone|"A single, 10-milligram (mg) dose administered orally on Day 1 of Treatment 1.~Timeframe: Treatment 1"
792125|NCT01432886|B3|Baseline|Total|Total of all reporting groups
792126|NCT01432886|B2|Baseline|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
792127|NCT01432886|B1|Baseline|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
792128|NCT01432886|P2|Participant Flow|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
792129|NCT01432886|P1|Participant Flow|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
792130|NCT01432886|O2|Outcome|E7389 With Triweekly Trastuzumab|"Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle.~Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses."
792131|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
792132|NCT01432886|O2|Outcome|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
792133|NCT01432886|O1|Outcome|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
792134|NCT01432886|E2|Reported Event|E7389 With Tri-weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously tri-weekly, with an initial dose of 8 mg/kg followed by 6 mg/kg for the remaining doses.
792135|NCT01432886|E1|Reported Event|E7389 With Weekly Trastuzumab|Eribulin mesylate (E7389) was administered intravenously on Day 1 and Day 8 of each 3 week cycle. Trastuzumab was administered intravenously weekly, with an initial dose of 4 mg/kg followed by 2 mg/kg for the remaining doses.
792136|NCT01432756|B5|Baseline|Total|Total of all reporting groups
792137|NCT01432756|B4|Baseline|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
792138|NCT01432756|B3|Baseline|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
792139|NCT01432756|B2|Baseline|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
792141|NCT01432756|P4|Participant Flow|Let's Talk Worksite Parenting Program - Adolescent Participant|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
792142|NCT01432756|P3|Participant Flow|Wait-list Control - Adolescent Partipants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
792143|NCT01432756|P2|Participant Flow|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
792144|NCT01432756|P1|Participant Flow|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
792145|NCT01432756|O4|Outcome|Let's Talk Worksite Parenting Program -Adolescent Participants|"Adolescent participants will have parents who are in the Let's Talk Worksite Parenting Program.~The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child."
792146|NCT01432756|O3|Outcome|Wait-list Control - Adolescent Participants|Adolescent wait-list control participants have parents who are in the wait-list control group. Their parents will not receive the intervention until after the 3-month follow-up assessment.
792147|NCT01432756|O2|Outcome|Let's Talk Worskite Parenting Program - Parent Participants|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
792148|NCT01432756|O1|Outcome|Wait-list Control - Parent Participants|Parent participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
792149|NCT01432756|E2|Reported Event|Let's Talk Worskite Parenting Program|"The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.~Let's Talk Worksite Parenting Program: The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence;"
792150|NCT01432756|E1|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 3-month follow-up assessment.
792151|NCT01432626|B1|Baseline|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
792174|NCT01432600|E2|Reported Event|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
792175|NCT01432600|E1|Reported Event|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
792279|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
792152|NCT01432626|P1|Participant Flow|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
792153|NCT01432626|O1|Outcome|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
792154|NCT01432626|E1|Reported Event|Stress Induced Cardiomyopathy Patients|"Patients with stress induced cardiomyopathy, by the Mayo criteria (normal coronary anatomy, EKG changes/Enzyme abnormalities, wall motion abnormalities consistent with stress induced cardiomyopathy and no evidence of pheochromocytoma) and signing informed consent, will receive an I123-mIBG scan to determine the sympathetic function of the heart during the acute presentation and after functional recovery.~I-123 radiolabeled metaiodobenzylguanidine cardiac imaging: All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later."
792155|NCT01432600|B4|Baseline|Total|Total of all reporting groups
792156|NCT01432600|B3|Baseline|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
792157|NCT01432600|B2|Baseline|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
792158|NCT01432600|B1|Baseline|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
792159|NCT01432600|P3|Participant Flow|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
792160|NCT01432600|P2|Participant Flow|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Arm D participants may be referenced separately in some Outcome Measures."
792161|NCT01432600|P1|Participant Flow|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
792162|NCT01432600|O3|Outcome|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D. Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.
792163|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
792164|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
792165|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
792166|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
792167|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
792168|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
792169|NCT01432600|O2|Outcome|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
792170|NCT01432600|O1|Outcome|B: Pomalidomide and Dexamethasone|"Phase II: Pomalidomide and high dose dexamethasone.~Crossover Arm D is a part of Arm B. Arm D was opened later to accommodate requested transfers from Arm B. Participants who experienced progressive disease in arm B were allowed to crossover to arm D at the discretion of the treating physician.~Arm D participants may be referenced separately in some Outcome Measures."
792171|NCT01432600|O1|Outcome|A: Dose Escalation of Cyclophosphamide|Phase I: Pomalidomide, high dose dexamethasone and oral cyclophosphamide.
792172|NCT01432600|E4|Reported Event|D: Crossover Arm|Phase II: Participants who crossed over from Arm B to Arm D.
792173|NCT01432600|E3|Reported Event|C: Pomalidomide, Dexamethasone, Cyclophosphamide|Phase II: Pomalidomide high dose dexamethasone and oral cyclophosphamide.
792176|NCT01432574|B1|Baseline|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
792177|NCT01432574|P1|Participant Flow|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
792178|NCT01432574|O2|Outcome|Gardasil Vaccine - Month 7|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
792179|NCT01432574|O1|Outcome|Gardasil Vaccine - Day 1|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
792180|NCT01432574|O1|Outcome|Gardasil Vaccine - Month 7|
792181|NCT01432574|E1|Reported Event|Gardasil Vaccine|"Vaccine Administration: A total of 3 injections (shots) at 3 separate visits.~Gardasil: The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3)."
792182|NCT01432561|B1|Baseline|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
792183|NCT01432561|P1|Participant Flow|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
792184|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
792185|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
792186|NCT01432561|O1|Outcome|Cysteamine Bitartrate|Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4
792187|NCT01432561|E1|Reported Event|Cysteamine Bitartrate|"Cysteamine bitartrate, 500mg once a day, three days.~Cysteamine bitartrate : 500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period."
792188|NCT01432535|B4|Baseline|Total|Total of all reporting groups
792189|NCT01432535|B3|Baseline|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792190|NCT01432535|B2|Baseline|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792191|NCT01432535|B1|Baseline|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792192|NCT01432535|P3|Participant Flow|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792193|NCT01432535|P2|Participant Flow|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792194|NCT01432535|P1|Participant Flow|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792195|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792196|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792197|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792198|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792199|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792200|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792201|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792202|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792203|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792277|NCT01432379|P1|Participant Flow|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
792204|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792205|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792206|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792207|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792208|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792209|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792210|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792211|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792212|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792213|NCT01432535|O3|Outcome|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792214|NCT01432535|O2|Outcome|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792215|NCT01432535|O1|Outcome|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792216|NCT01432535|E3|Reported Event|Participants With Severe Renal Impairment|Participants with severe renal impairment defined as having a creatinine clearance test value of <30 mL/min/1.73 m^2 or end stage renal disease on hemodialysis. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792217|NCT01432535|E2|Reported Event|Participants With Moderate Renal Impairment|Participants with moderate renal impairment defined as having a creatinine clearance test value of 30-50 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792218|NCT01432535|E1|Reported Event|Healthy Participants|Participants with normal renal function, defined as having a creatinine clearance test value of ≥80 mL/min/1.73 m^2. Participants receive a single subcutaneous dose of PegIFN-2b, 4.5 μg/kg.
792219|NCT01432457|B4|Baseline|Total|Total of all reporting groups
792220|NCT01432457|B3|Baseline|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792221|NCT01432457|B2|Baseline|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792222|NCT01432457|B1|Baseline|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792223|NCT01432457|P3|Participant Flow|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792224|NCT01432457|P2|Participant Flow|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792225|NCT01432457|P1|Participant Flow|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792226|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792227|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792228|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792229|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792230|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792231|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792232|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792233|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792234|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792235|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792236|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792237|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792238|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792239|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792240|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792241|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792242|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792243|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792244|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792245|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792246|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792247|NCT01432457|O3|Outcome|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792248|NCT01432457|O2|Outcome|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792249|NCT01432457|O1|Outcome|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792250|NCT01432457|E3|Reported Event|DVS SR 100 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 100 milligrams (mg) group received 50 mg DVS SR tablets each day for first week of treatment, 100 mg DVS SR tablets each day through the remainder of the 8-week double-blind treatment and received 50 mg DVS SR tablets each day during 1-week taper.
792251|NCT01432457|E2|Reported Event|DVS SR 50 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 50 milligrams (mg) group received 50 mg DVS SR tablets through the 8-weeks of double-blind treatment and received placebo tablets each day during 1-week taper.
792252|NCT01432457|E1|Reported Event|Placebo|Placebo group received placebo tablets through 8-weeks of double-blind treatment and during 1-week of taper.
792253|NCT01432444|B1|Baseline|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792254|NCT01432444|P3|Participant Flow|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believes would receive benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
792255|NCT01432444|P2|Participant Flow|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792302|NCT01432327|B2|Baseline|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
792256|NCT01432444|P1|Participant Flow|Tolerability/Cross-titration Phase (Phase A)|In Phase A, participants who had no history of tolerating oral aripiprazole entered a Tolerability Assessment/Cross-titration Phase in order to assess tolerability to oral aripiprazole. The recommended initial dose of oral aripiprazole in the Tolerability Assessment/Cross-titration Phase was 10 mg or 15 mg/day, depending on the participant's symptoms and the study physician's judgment. Participants were seen in the clinic at baseline and weekly thereafter for a minimum of 1 week and maximum of 4 weeks/28 days, until tolerability to oral aripiprazole had been determined, based on physician's discretion, or until the participant was terminated from the study.
792257|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792258|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792259|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792260|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792261|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792262|NCT01432444|O1|Outcome|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792263|NCT01432444|E2|Reported Event|Extension Phase (Phase C)|Participants who completed the 24-Week treatment period (Phase B), and whom the study physician believed would benefit from continued treatment with aripiprazole IM depot, were eligible to enter Phase C. During Phase C, participants were to continue treatment with aripiprazole IM depot until approximately 400 subjects have enrolled in Phase B (in order to achieve approximately 200 Phase B completers).
792264|NCT01432444|E1|Reported Event|Open-label Aripiprazole IM Depot Treatment Phase (Phase B)|In Phase B, all participants received aripiprazole IM depot 400 mg and had received supplemental oral aripiprazole for the first 14 days of Phase B (open-label aripiprazole IM depot treatment phase) for more than or equal to 3 months. However, at the discretion of the study physician, the dose of aripiprazole IM depot was decreased to 300 mg only if needed for tolerability and subsequently increased the dose to 400 mg for efficacy as required. This dose adjustment was permitted as often as necessary to maintain symptomatic stability with acceptable tolerability. For purposes of this study, participants who completed Week 24 of Phase B were defined as trial completers.
792265|NCT01432405|B3|Baseline|Total|Total of all reporting groups
792266|NCT01432405|B2|Baseline|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792278|NCT01432379|O1|Outcome|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
793340|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
792267|NCT01432405|B1|Baseline|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792268|NCT01432405|P2|Participant Flow|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792269|NCT01432405|P1|Participant Flow|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792270|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792271|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792272|NCT01432405|O2|Outcome|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792273|NCT01432405|O1|Outcome|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792274|NCT01432405|E2|Reported Event|Pioglitazone|"Pioglitazone 45 mg daily orally for 12 months~Pioglitazone: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792275|NCT01432405|E1|Reported Event|Pioglitazone and Exenatide|"Exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months.~Pioglitazone and exenatide: Type 2 diabetic subjects will be randomized to receive either pioglitazone 45 mg daily orally or exenatide 10 micrograms injected subcutaneously twice daily plus pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period."
792276|NCT01432379|B1|Baseline|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
793341|NCT01429584|E2|Reported Event|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
792280|NCT01432379|E1|Reported Event|Botulinum Toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
792281|NCT01432366|B1|Baseline|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792282|NCT01432366|P1|Participant Flow|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792283|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792284|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792285|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792286|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792287|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792288|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792289|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792290|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792291|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792292|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792293|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792294|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792295|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792296|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792297|NCT01432366|O1|Outcome|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792298|NCT01432366|E1|Reported Event|Anti-Tumour Necrosis Factor Alpha (Anti-TNF-alpha)|Participants with rheumatoid arthritis (RA), who were on stable therapy and received subcutaneous anti-TNF-alpha treatment for at least 1 consecutive year as per treating physician’s discretion based on summary of product characteristics, were followed up for 1 year.
792299|NCT01432327|B5|Baseline|Total|Total of all reporting groups
792300|NCT01432327|B4|Baseline|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
792301|NCT01432327|B3|Baseline|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
792303|NCT01432327|B1|Baseline|Control Group|This group receives no kind of feedback during the intervention period
793355|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
792304|NCT01432327|P4|Participant Flow|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
792305|NCT01432327|P3|Participant Flow|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
792306|NCT01432327|P2|Participant Flow|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
792307|NCT01432327|P1|Participant Flow|Control Group|This group receives no kind of feedback during the intervention period
792308|NCT01432327|O4|Outcome|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
792309|NCT01432327|O3|Outcome|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
792310|NCT01432327|O2|Outcome|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
792311|NCT01432327|O1|Outcome|Control Group|This group receives no kind of feedback during the intervention period
792312|NCT01432327|E4|Reported Event|Coaching Group|Participants receive real-time feedback on their energy expenditure, step count and minutes of physical activity by means of the SenseWear Display and weekly meet with a Personal Coach to discuss their progress
792313|NCT01432327|E3|Reported Event|Display Group|Participants receive real time feedback on their energy expenditure, minutes of physical activity and step count by means of the SenseWear Display
792314|NCT01432327|E2|Reported Event|Step Group|This group receives feedback about the daily amount of steps by means of a pedometer.
792315|NCT01432327|E1|Reported Event|Control Group|This group receives no kind of feedback during the intervention period
792316|NCT01432262|B3|Baseline|Total|Total of all reporting groups
792317|NCT01432262|B2|Baseline|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792318|NCT01432262|B1|Baseline|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792319|NCT01432262|P2|Participant Flow|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792320|NCT01432262|P1|Participant Flow|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792321|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792322|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792323|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792324|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792325|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792326|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792327|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792328|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792329|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792330|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792331|NCT01432262|O2|Outcome|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792332|NCT01432262|O1|Outcome|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792333|NCT01432262|E2|Reported Event|13vPnC, Cohort 2|Participants greater than or equal to (>=) 65 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly on Day 1.
792334|NCT01432262|E1|Reported Event|13vPnC, Cohort 1|Participants 50 to 64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly on Day 1.
792335|NCT01432236|B3|Baseline|Total|Total of all reporting groups
792336|NCT01432236|B2|Baseline|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792491|NCT01431703|E1|Reported Event|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
792492|NCT01431521|B5|Baseline|Total|Total of all reporting groups
792493|NCT01431521|B4|Baseline|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
792655|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792337|NCT01432236|B1|Baseline|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792338|NCT01432236|P2|Participant Flow|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792339|NCT01432236|P1|Participant Flow|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792340|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
792341|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
792342|NCT01432236|O1|Outcome|All Participants|All randomized participants were included in this analysis.
792343|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792344|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792345|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792346|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792347|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792348|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792349|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792350|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792351|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792494|NCT01431521|B3|Baseline|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
792495|NCT01431521|B2|Baseline|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
793342|NCT01429584|E1|Reported Event|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
792352|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792353|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792354|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792355|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792356|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792357|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792358|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792359|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792360|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792361|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792362|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792363|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792496|NCT01431521|B1|Baseline|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792497|NCT01431521|P4|Participant Flow|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
792364|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792365|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792366|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792367|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792368|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792369|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792370|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792371|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792372|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792373|NCT01432236|O2|Outcome|Placebo|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792374|NCT01432236|O1|Outcome|Pregabalin|This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792375|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792498|NCT01431521|P3|Participant Flow|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
792499|NCT01431521|P2|Participant Flow|Placebo for MK-4074|Participants will receive oral doses of placebo to match MK-4074 twice daily for 4 weeks.
792376|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792377|NCT01432236|O2|Outcome|Placebo/Pregabalin|Participants were randomized in a 1:1 ratio to double-blind treatment with placebo for 6 weeks in period 1 followed by pregabalin in period 2 (3 weeks dose optimization and 3 weeks fixed dose) with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process in period 2. There was a 2-week single-blind taper/washout period between treatment periods
792378|NCT01432236|O1|Outcome|Pregabalin/Placebo|Participants were randomized in a 1:1 ratio to double-blind treatment with pregabalin for 6 weeks (3 weeks dose optimization and 3 weeks fixed dose) in period 1 followed by placebo in period 2 with background antidepressants. Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792379|NCT01432236|O2|Outcome|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792380|NCT01432236|O1|Outcome|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792381|NCT01432236|E2|Reported Event|Placebo|The below table included participants who received placebo in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). There was a 2-week single-blind taper/washout period between treatment periods.
792382|NCT01432236|E1|Reported Event|Pregabalin|The below table included participants who received pregabalin in either treatment period pooled together due to the crossover study design. This crossover study consisted of two double blind 6-week treatment periods where participants were randomized to pregabalin or placebo for the first period, and were then switched to the other treatment for the second period (3 weeks dose optimization and 3 weeks fixed dose for each treatment period). Pregabalin was administered as immediate release (IR) capsule with a starting dose of 150 mg/day and increased up to 300 - 450 mg/day during the dose optimization process. There was a 2-week single-blind taper/washout period between treatment periods.
792383|NCT01432015|B3|Baseline|Total|Total of all reporting groups
792384|NCT01432015|B2|Baseline|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
792385|NCT01432015|B1|Baseline|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
792386|NCT01432015|P2|Participant Flow|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
792387|NCT01432015|P1|Participant Flow|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3. Patient will receive standard pre-medications on day 1
792388|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
792462|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
792389|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
792390|NCT01432015|O2|Outcome|Aprepitant Including Placebo|"Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo and 80 mg orally once daily in the morning on Days 2 and 3 with Placebo Intravenously on day 1. patient will receive standard pre-medications on day 1.~aprepitant including placebo: Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications"
792391|NCT01432015|O1|Outcome|Fosaprepitant Including Placebo|"Fosaprepitant (EMEND™) for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1~Aprepitant (EMEND™) is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3~fosaprepitant including placebo: Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications"
792392|NCT01432015|E2|Reported Event|Aprepitant and Placebo|Aprepitant is 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) with Intravenous Placebo on day 1 and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications on day 1.
792393|NCT01432015|E1|Reported Event|Fosaprepitant and Placebo|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy.Oral Placebo 125 mg given 1 hour prior to infusion of chemotherapy on day 1 and oral Placebo 80 mg on day 2 and day 3.Patient will receive standard pre-medications on day 1
792394|NCT01431989|B1|Baseline|Participants Receiving Both Test and Reference Products|Participants receiving either test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2 or reference product in Period 1 and test product inPeriod 2
792395|NCT01431989|P2|Participant Flow|Reference Product in Period 1: Test Product in Period 2|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, in Period 2
792396|NCT01431989|P1|Participant Flow|Test Product in Period 1: Reference Product in Period 2|Test product, Amoxicillin (Clamoxyl) 500 milligrams (mg)/5 milliliter (mL) powder for oral suspension, in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product, Amoxil 500 mg/5 mL powder for oral suspension, in Period 2
792397|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792398|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792399|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792400|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792401|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792402|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792403|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792404|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792405|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792406|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792407|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792408|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792409|NCT01431989|O2|Outcome|Reference Product|Reference product, Amoxil 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792410|NCT01431989|O1|Outcome|Test Product|Test product, Amoxicillin (Clamoxyl) 500 mg/5 mL powder for oral suspension, received in either Period 1 or Period 2
792411|NCT01431989|E2|Reported Event|Reference Product in Period 1 and Test Product in Period 2|Reference product: Amoxil 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by test product: Clamoxyl 500 mg/5 mL in Period 2
792412|NCT01431989|E1|Reported Event|Test Product in Period 1 and Reference Product in Period 2|Test product: Amoxicillin powder for oral suspension (Clamoxyl) 500 mg/5 mL in Period 1; followed by a 14-day washout period during which no medication was administered; followed by reference product; Amoxil 50 mg/5 mL in Period 2
792500|NCT01431521|P1|Participant Flow|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792501|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
792502|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
792413|NCT01431976|B1|Baseline|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792414|NCT01431976|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 0.3 milligrams per kilogram per day (mg/kg/day) was administered orally once daily from Week W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, whichever was less (WWL), until a seizure-free (SF) status was confirmed by hyperventilation (HV)-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792415|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792416|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792417|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792418|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792419|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792420|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792503|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792654|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792421|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792422|NCT01431976|O1|Outcome|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at >=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose <1.2 mg/kg/day or >10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792423|NCT01431976|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 0.3 mg/kg/day was administered orally once daily from W1 to W2, and 0.6 mg/kg/day from W3 to W4. From W5, the dose was escalated by 0.6 mg/kg/day once every 1 or 2 weeks, up to a maximum of 10.2 mg/kg/day or 400 mg/day, WWL, until a SF status was confirmed by HV-clinical signs. After a SF confirmation, the dose was increased by one level and HV-electroencephalography was assessed twice at the same dose level to confirm the SF status. In the MP, the same dose was continued for 12 weeks. An increase/decrease in dose (0.6 mg/kg/day at &gt;=1-week intervals) was allowed within the range of 1.2 to 10.2 mg/kg/day or 400 mg/day, WWL. In the ExP, doses of 1.2 to 10.2 mg/kg/day or 400 mg/day (WWL) were administered based on seizure status/safety. If a dose &lt;1.2 mg/kg/day or &gt;10.2 mg/kg/day or 400 mg/day (WWL) was necessary, the participant was withdrawn from the study.
792424|NCT01431963|B1|Baseline|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
792425|NCT01431963|P1|Participant Flow|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
792426|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
792427|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
792463|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
792504|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
793343|NCT01429532|B4|Baseline|Total|Total of all reporting groups
792428|NCT01431963|O1|Outcome|Lamotrigine|In the EP, lamotrigine 25 milligrams per day (mg/day) was orally administered once daily (QD; in the evening [PM]) as the initial dose from Week (W) 1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD (in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, lamotrigine 200 mg/day was orally administered QD (in the PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at >=1-week intervals. A dose >200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose <100 or >400 mg/day was judged to be necessary, the participant was withdrawn from the study.
792429|NCT01431963|E1|Reported Event|Lamotrigine|In the EP, lamotrigine 25 mg/day was orally administered QD; in the evening(PM) as the initial dose from W1 to W2. As a fixed dose escalation, lamotrigine 50 mg/day was orally administered QD(in the PM) from W3 to W4; 100 mg/day was administered from W5 to W6. In the MP, Lamotrigine 200 mg/day was orally administered QD(PM) from W7 to W30. The dose could have been decreased to 100 mg/day per safety concerns. Per investigator discretion, the investigational product was discontinued if safety concerns remained. If the 200 mg/day dose did not control seizures, the dose could have been increased up to 400 mg/day by 50-100 mg/day at greater than or equal to 1 week intervals. A dose greater than 200 mg/day could have been administered in 2 divided doses (in the morning and PM). In the ExP, lamotrigine was administered at 100-400 mg/day based on seizure status/safety. If a dose less than 100 or greater than 400 mg/day was judged to be necessary, the participant was withdrawn from the study.
792430|NCT01431950|B3|Baseline|Total|Total of all reporting groups
792431|NCT01431950|B2|Baseline|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792432|NCT01431950|B1|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792433|NCT01431950|P2|Participant Flow|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792434|NCT01431950|P1|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792435|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792436|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792437|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792438|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792439|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792440|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792441|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792442|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792443|NCT01431950|O2|Outcome|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792444|NCT01431950|O1|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792445|NCT01431950|E2|Reported Event|FF 200 µg OD|Participants received FF 200 µg via a DPI OD in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792446|NCT01431950|E1|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 micrograms (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening for 24 weeks. In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
792447|NCT01431846|B4|Baseline|Total|Total of all reporting groups
792464|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
792448|NCT01431846|B3|Baseline|Arm 3|"Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention~Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical att"
792449|NCT01431846|B2|Baseline|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
792450|NCT01431846|B1|Baseline|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
792451|NCT01431846|P3|Participant Flow|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
792452|NCT01431846|P2|Participant Flow|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
792453|NCT01431846|P1|Participant Flow|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
792454|NCT01431846|O3|Outcome|Arm 3|Informed by interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1)PCP follow-up within 2-4 weeks of hospital discharge; 2)medications reconciled between pre and post-hospital discharge; 3)discharge summary available to PCP at time of visit; and 4)patient awareness of symptoms that require medical attention Intervention: Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
792455|NCT01431846|O2|Outcome|Arm 2|Three providers who refer patients to the Denver VA Medical Center for cardiac care were interviewed to identify barriers and facilitators from their perspective of following-up with patients after their hospitalization at Denver VAMC. Additionally, the same information was asked of providers who participated in two focus groups in the Grand Junction VA.
792456|NCT01431846|O1|Outcome|Arm 1|Eight patients who were being discharged from Denver VA Medical Center for cardiac care to their primary care providers were recruited at the time of discharge and completed an interview two weeks following their discharge. Patients were asked to describe their transition to home and identify barriers and facilitators of this process, their understanding of their medical condition, new medications prescribed, timeliness of follow-up visit with their PCP and knowledge of signs/symptoms in which they should seek medical attention.
792457|NCT01431846|E3|Reported Event|Intervention|Total number at risk was 8. Zero adverse events were seen.
792458|NCT01431846|E2|Reported Event|Providers|Total number at risk was 3. Zero adverse events were seen.
792459|NCT01431846|E1|Reported Event|Discharged Patients|Total number at risk was 8. Zero adverse events were seen.
792460|NCT01431755|B1|Baseline|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended
792461|NCT01431755|P1|Participant Flow|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
793344|NCT01429532|B3|Baseline|Group III|3.0-mm-incision-size phacoemulsification system
792465|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
792466|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
792467|NCT01431755|O1|Outcome|Restylane SubQ/Restylane SubQ Lidocaine|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.
792468|NCT01431755|E3|Reported Event|Restylane SubQ Lidocaine: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
792469|NCT01431755|E2|Reported Event|Restylane SubQ: Localized|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time
792470|NCT01431755|E1|Reported Event|Restylane SubQ/Restylane SubQ Lidocaine: Systemic|The study has a split-face design. Each subject was injected with Restylane SubQ in one cheek and Restylane SubQ Lidocaine in the contralateral cheek as randomized. Half of the subjects received both study products by injections with a sharp needle and the other half received both study products by injection with a blunt ended microcannula. Following the initial treatment there was a one year follow-up period including an optional re-treatment at 3 months. A maximum volume of 2 ml per cheek and session was recommended.Hence, all subjects received injections with both products at the same time.
792471|NCT01431716|B1|Baseline|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792472|NCT01431716|P1|Participant Flow|Epoprostenol for Injection (EFI/ACT-385781A)|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792473|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792474|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792475|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792476|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792477|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792478|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792479|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792480|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792481|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792482|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792483|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792484|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792485|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792486|NCT01431716|O1|Outcome|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792487|NCT01431716|E1|Reported Event|EFI/ACT-385781A|EFI/ACT-385781A administered by continuous intravenous infusion via a central venous catheter using an ambulatory infusion pump.
792488|NCT01431703|B1|Baseline|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
792489|NCT01431703|P1|Participant Flow|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
792490|NCT01431703|O1|Outcome|NBI With Magnification|Patients with lesions diagnosed by Sano classification using NBI with magnification
793345|NCT01429532|B2|Baseline|Group II|2.2-mm-incision-size phacoemulsification system
792505|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
792506|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792507|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
792508|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
792509|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792510|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
792511|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
792512|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792513|NCT01431521|O3|Outcome|Placebo|Participants will receive oral doses of placebo to match MK-4074 or pioglitazone hydrochloride once daily for 4 weeks.
792514|NCT01431521|O2|Outcome|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg (1 x 30-mg tablet) once daily for 4 weeks.
792515|NCT01431521|O1|Outcome|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792516|NCT01431521|E4|Reported Event|Placebo for Pioglitazone|Participants will receive oral doses of placebo to match pioglitazone hydrochloride once daily for 4 weeks.
792517|NCT01431521|E3|Reported Event|Pioglitazone|Participants will receive oral doses of pioglitazone hydrochloride 30 mg once daily for 4 weeks.
792518|NCT01431521|E2|Reported Event|Placebo for MK-4074|Participants will receive oral doses of placebo matching MK-4074 twice daily for 4 weeks.
792519|NCT01431521|E1|Reported Event|MK-4074|Participants will receive oral doses of MK-4074 200 mg (2 x 100-mg capsules) twice daily for 4 weeks.
792520|NCT01431508|B1|Baseline|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / HCTZ 12.5 mg once-a-day for 12 weeks.
792521|NCT01431508|P1|Participant Flow|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
792522|NCT01431508|O1|Outcome|Losartan 50 mg / HCTZ 12.5 mg|Participants with mild to moderate essential hypertension who will receive Losartan 50 mg / Hydrochlorothiazide (HCTZ) 12.5 mg once-a-day for 12 weeks.
792523|NCT01431508|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|
792524|NCT01431391|B3|Baseline|Total|Total of all reporting groups
792525|NCT01431391|B2|Baseline|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
792526|NCT01431391|B1|Baseline|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
792527|NCT01431391|P2|Participant Flow|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
792528|NCT01431391|P1|Participant Flow|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
792529|NCT01431391|O2|Outcome|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
792530|NCT01431391|O1|Outcome|Arm 1:Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started androgen deprivation therapy (ADT) with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
792531|NCT01431391|O2|Outcome|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
792532|NCT01431391|O1|Outcome|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
792571|NCT01431287|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792612|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792533|NCT01431391|E2|Reported Event|Arm 2: ADT Followed by Sipuleucel-T|Subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg) 12 weeks before infusion 1 of sipuleucel-T. An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT. Twelve weeks after the initial leuprolide 45 mg depot injection, subjects began one infusion of sipuleucel-T every two weeks for a total of three infusions.
792534|NCT01431391|E1|Reported Event|Arm 1: Sipuleucel-T Followed by ADT|Subjects received one infusion of sipuleucel-T every two weeks for a total of three infusions. Two weeks after the third sipuleucel-T infusion, subjects started ADT with 45 mg leuprolide acetate depot injection (Eligard® 45 mg). An additional leuprolide acetate injection was administered at 6 months after the first injection for a total of 2 injections and 12 months of ADT.
792535|NCT01431339|B3|Baseline|Total|Total of all reporting groups
792536|NCT01431339|B2|Baseline|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
792537|NCT01431339|B1|Baseline|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
792538|NCT01431339|P2|Participant Flow|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
792539|NCT01431339|P1|Participant Flow|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
792540|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
792541|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
792542|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
792543|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
792544|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
792545|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
792546|NCT01431339|O2|Outcome|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
792547|NCT01431339|O1|Outcome|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
792548|NCT01431339|E2|Reported Event|Vancomycin With Possible Switch to Oral Linezolid|Vancomycin/Linezolid: IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
792549|NCT01431339|E1|Reported Event|Dalbavancin|IV Dalbavancin: IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
792550|NCT01431300|B4|Baseline|Total|Total of all reporting groups
792551|NCT01431300|B3|Baseline|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
792552|NCT01431300|B2|Baseline|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792553|NCT01431300|B1|Baseline|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792554|NCT01431300|P3|Participant Flow|0.03 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition. This is the FDA-approved dose for lower extremity arterial imaging
792555|NCT01431300|P2|Participant Flow|0.02 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
792556|NCT01431300|P1|Participant Flow|0.01 mmol/kg of Gadofosveset|Intravenous administration of gadofosveset via power injector at onset of MRI image acquisition
792557|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
792558|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792559|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792560|NCT01431300|O3|Outcome|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
792561|NCT01431300|O2|Outcome|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792562|NCT01431300|O1|Outcome|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792563|NCT01431300|E3|Reported Event|0.03 mmol/kg|"FDA-approved dose for lower extremity arterial imaging~gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent"
792564|NCT01431300|E2|Reported Event|0.02 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792565|NCT01431300|E1|Reported Event|0.01 mmol/kg|gadofosveset : Intravenous administration of the specified dosage of gadolinium contrast agent
792566|NCT01431287|B6|Baseline|Total|Total of all reporting groups
792567|NCT01431287|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792568|NCT01431287|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792569|NCT01431287|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792570|NCT01431287|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792572|NCT01431287|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792573|NCT01431287|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792574|NCT01431287|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792575|NCT01431287|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792576|NCT01431287|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792577|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792578|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792579|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792580|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792581|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792582|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792583|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792584|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792585|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792586|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792587|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792588|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792589|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792590|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792591|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792592|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792593|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792594|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792595|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792596|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792597|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792598|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792599|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792600|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792601|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792602|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792603|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792604|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792605|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792606|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792607|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792608|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792609|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792610|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792611|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792613|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792614|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792615|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792616|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792617|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792618|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792619|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792620|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792621|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792622|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792623|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792624|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792625|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792626|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792627|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792628|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792629|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792630|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792631|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792632|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792633|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792634|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792635|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792636|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792637|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792638|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792639|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792640|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792641|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792642|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792643|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792644|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792645|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792646|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792647|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792648|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792649|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792650|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792651|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792652|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792653|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
793346|NCT01429532|B1|Baseline|Group I|1.8-mm-incision-size phacoemulsification system
792656|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792657|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792658|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792659|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792660|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792661|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792662|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792663|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792664|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792665|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792666|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792667|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792668|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792669|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792670|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792671|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792672|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792673|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792674|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792675|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792676|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792677|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792678|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792679|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792680|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792681|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792682|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792683|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792684|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792685|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792686|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792687|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792688|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792689|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792690|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792691|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792692|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792693|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792694|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792695|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792696|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792697|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792698|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792699|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792700|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792701|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792702|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792703|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792704|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792705|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792706|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792707|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792708|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792709|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792710|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792711|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792712|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792713|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792714|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792715|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792716|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792717|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792718|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792719|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792720|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792721|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792722|NCT01431287|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792723|NCT01431287|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of FDC of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation), 2 puffs in the morning.
792724|NCT01431287|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792725|NCT01431287|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation), 2 puffs in the morning.
792726|NCT01431287|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation), 2 puffs in the morning.
792727|NCT01431287|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792728|NCT01431287|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792729|NCT01431287|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792730|NCT01431287|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792731|NCT01431287|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792732|NCT01431274|B6|Baseline|Total|Total of all reporting groups
792733|NCT01431274|B5|Baseline|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792734|NCT01431274|B4|Baseline|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792735|NCT01431274|B3|Baseline|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792736|NCT01431274|B2|Baseline|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792737|NCT01431274|B1|Baseline|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792738|NCT01431274|P5|Participant Flow|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792739|NCT01431274|P4|Participant Flow|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792740|NCT01431274|P3|Participant Flow|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792741|NCT01431274|P2|Participant Flow|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792742|NCT01431274|P1|Participant Flow|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792743|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792744|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792745|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792746|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792747|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792748|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792749|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792750|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792751|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792752|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792753|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792754|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792755|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792756|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792757|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792758|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792759|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792760|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792761|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792762|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792763|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792764|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792765|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792766|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792767|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792768|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792769|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792770|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792771|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792772|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792773|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792774|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792775|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792776|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792777|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792778|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792779|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792780|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792781|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792782|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792783|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792784|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792785|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792786|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792787|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792788|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792789|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792790|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792791|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792792|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792793|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792794|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792795|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792796|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792797|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792798|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792799|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792800|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792801|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792802|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792803|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792871|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792804|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792805|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792806|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792807|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792808|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792809|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792810|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792811|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792812|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792813|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792814|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792815|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792816|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792817|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792818|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792819|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792820|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792821|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792822|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792823|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792824|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792825|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792826|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792827|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792828|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792829|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792830|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792831|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792832|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792833|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792834|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792835|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792836|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792837|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792838|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792839|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792840|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792841|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792842|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792843|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792844|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792845|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792846|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792847|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792848|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792849|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792850|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792851|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792852|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792853|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792854|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792855|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792856|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792857|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792858|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792859|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792860|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792861|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792862|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792863|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792864|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792865|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792866|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792867|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792868|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792869|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792870|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
793347|NCT01429532|P3|Participant Flow|Group III|3.0-mm-incision-size phacoemulsification system
792872|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792873|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792874|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792875|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792876|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792877|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792878|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792879|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792880|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792881|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792882|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792883|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792884|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792885|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792886|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792887|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792888|NCT01431274|O5|Outcome|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792889|NCT01431274|O4|Outcome|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792890|NCT01431274|O3|Outcome|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792891|NCT01431274|O2|Outcome|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792892|NCT01431274|O1|Outcome|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792893|NCT01431274|E5|Reported Event|Tio+Olo FDC (5/5 μg)|Oral inhalation of FDC of Tiotropium 5 μg and Olodaterol 5 μg (Tiotropium and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792894|NCT01431274|E4|Reported Event|Tio+Olo FDC (2.5/5 μg)|Oral inhalation of fixed dose combination (FDC) of Tiotropium 2.5 μg and Olodaterol 5 μg (Tiotropium: 1.25 μg per actuation and Olodaterol: 2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792895|NCT01431274|E3|Reported Event|Tiotropium (5 μg)|Oral inhalation of Tiotropium 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792896|NCT01431274|E2|Reported Event|Tiotropium (2.5 μg)|Oral inhalation of Tiotropium 2.5 μg (1.25 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792897|NCT01431274|E1|Reported Event|Olodaterol (5 μg)|Oral inhalation of Olodaterol 5 μg (2.5 μg per actuation) , 2 puffs from the RESPIMAT inhaler, once daily, in the morning.
792898|NCT01431170|B3|Baseline|Total|Total of all reporting groups
792899|NCT01431170|B2|Baseline|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
792900|NCT01431170|B1|Baseline|Besivance Treatment Group|Subjects received Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
792901|NCT01431170|P2|Participant Flow|Polytrim Treatment Group|Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily for 10 days.
792902|NCT01431170|P1|Participant Flow|Besivance Treatment Group|Subjects receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily for 10 days.
792903|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects treated with Polytrim ophthalmic solution, who achieved treatment success by the study close-out visit (week 16).
792904|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects treated with Besivance™ ophthalmic suspension, 0.6%, who achieved treatment success by the study close-out visit (week 16).
792905|NCT01431170|O2|Outcome|Polytrim Safety Outcomes|Number of reported medication safety issues in the Polytrim Treatment Group
792906|NCT01431170|O1|Outcome|Besivance Safety Outcomes|Number of reported medication safety issues in the Besivance Treatment Group.
792907|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of Treatment Failures for subjects randomized to the Polytrim treatment group.
792908|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of Treatment Failures for subjects randomized to the Besivance treatment group.
792909|NCT01431170|O2|Outcome|Efficacy of Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
792910|NCT01431170|O1|Outcome|Efficacy of Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
792911|NCT01431170|O2|Outcome|Polytrim Treatment Group|Number of subjects who had a recurrence randomized to the Polytrim treatment group,
792912|NCT01431170|O1|Outcome|Besivance Treatment Group|Number of subjects who had a recurrence randomized to the Besivance treatment group.
792913|NCT01431170|O2|Outcome|Polytrim Treatment Group|Subjects received Polytrim ophthalmic solution in the study eye, one drop three times daily for ten days.
792914|NCT01431170|O1|Outcome|Besivance Treatment Group|Subjects received Besivance ophthalmic solution in the study eye, one drop three times a day for ten days
792915|NCT01431170|E2|Reported Event|Polytrim Treatment Group|Subjects randomized to the Polytrim treatment group.
792916|NCT01431170|E1|Reported Event|Besivance Treatment Group|Subjects randomized to the Besivance treatment group.
792917|NCT01431144|B3|Baseline|Total|Total of all reporting groups
792918|NCT01431144|B2|Baseline|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792919|NCT01431144|B1|Baseline|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792920|NCT01431144|P2|Participant Flow|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792921|NCT01431144|P1|Participant Flow|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792922|NCT01431144|O2|Outcome|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792923|NCT01431144|O1|Outcome|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792924|NCT01431144|E2|Reported Event|Connective Tissue Autograft|A connective tissue autograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792925|NCT01431144|E1|Reported Event|Connective Tissue Allograft|A connective tissue allograft was placed simultaneously with dental implant placement and soft tissue thickness was measured at baseline and Time 4.
792926|NCT01431131|B3|Baseline|Total|Total of all reporting groups
792927|NCT01431131|B2|Baseline|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
792928|NCT01431131|B1|Baseline|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
792929|NCT01431131|P2|Participant Flow|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
792930|NCT01431131|P1|Participant Flow|Intrasocket Graft|Positive control, an intrasocket cancellous allograft is placed
792931|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
792932|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
792933|NCT01431131|O2|Outcome|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
792934|NCT01431131|O1|Outcome|Intrasocket Graft|Positive control, an intrasocket cancellous allograft was placed
792935|NCT01431131|E2|Reported Event|Intrasocket Plus Facial Overlay Graft|Intrasocket cancellous allograft plus a facial overlay bovine xenograft
792936|NCT01431131|E1|Reported Event|Intrasocket Graft|Positive control, an intrasocket cancellous allograft will be placed
792937|NCT01431079|B3|Baseline|Total|Total of all reporting groups
792938|NCT01431079|B2|Baseline|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792939|NCT01431079|B1|Baseline|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792940|NCT01431079|P2|Participant Flow|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792941|NCT01431079|P1|Participant Flow|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792942|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
792943|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792944|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
792945|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792972|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This control group will provide follow-up data for knowledge based education for HPV vaccine
792946|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792947|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792948|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
792949|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792950|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
792951|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792952|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792953|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792954|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
792955|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792956|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
792957|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792958|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792959|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792960|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for an education based on knowledge regarding HPV vaccine acceptability.
792961|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792962|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for an education based on knowledge regarding HPV vaccine acceptability.
792963|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide posttest data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792964|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792965|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792966|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data for education based on knowledge regarding HPV vaccine acceptability.
792967|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792968|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data for education based on knowledge regarding HPV vaccine acceptability.
792969|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792970|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792971|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide base line data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792973|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental group will provide follow-up data for an Health belief model based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792974|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This control group will provide post test data for knowledge based education for HPV vaccine
792975|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental group will provide post test data for an HBM based educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792976|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792977|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792978|NCT01431079|O6|Outcome|Follow-up Knowledge Based Education|This comparison arm will provide follow-up data regarding education based on knowledge regarding HPV vaccine acceptability.
792979|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792980|NCT01431079|O4|Outcome|Post Test Knowledge Based Education|This comparison arm will provide post test data regarding education based on knowledge regarding HPV vaccine acceptability.
792981|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792982|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data regarding education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792983|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792984|NCT01431079|O6|Outcome|Follow-up Knowledge-based Education|This comparison arm will provide follow-up data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
792985|NCT01431079|O5|Outcome|Follow-up Health Belief Model Based Education|This experimental arm will provide follow-up data for number of people who have taken HPV vaccine upto 3 months after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792986|NCT01431079|O4|Outcome|Post Test Knowledge-based Education|This comparison arm will provide post test data for number of people who have taken the HPV vaccine after an education based on knowledge regarding HPV vaccine acceptability.
792987|NCT01431079|O3|Outcome|Post Test Health Belief Model Based Education|This experimental arm will provide post test data for number of people who have taken HPV vaccine after an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.
792988|NCT01431079|O2|Outcome|Baseline Knowledge-based Education|"This comparison arm will provide baseline data for number of people who have taken the HPV vaccine before an education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792989|NCT01431079|O1|Outcome|Baseline Health Belief Model Based Education|"This experimental arm will provide baseline data for number of people who have taken HPV vaccine before an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792990|NCT01431079|E2|Reported Event|Knowledge-based Education|"This comparison arm will provide education based on knowledge regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792991|NCT01431079|E1|Reported Event|Health Belief Model Based Education|"This experimental arm will provide an educational intervention designed to modify constructs of health belief model regarding HPV vaccine acceptability.~HPV vaccine acceptability : One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention."
792992|NCT01431014|B3|Baseline|Total|Total of all reporting groups
792993|NCT01431014|B2|Baseline|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
792994|NCT01431014|B1|Baseline|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
792995|NCT01431014|P2|Participant Flow|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose : 5mg"
792996|NCT01431014|P1|Participant Flow|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose : 15 mg"
792997|NCT01431014|O2|Outcome|"DexamethasoneLow-dose"|"5mg Dexamethasonelow-dose : 5 mg"
792998|NCT01431014|O1|Outcome|"DexamethasoneHigh-dose"|"15mg Dexamethasonehigh-dose : 15 mg"
792999|NCT01431014|E2|Reported Event|"DexamethasoneHigh-dose"|"15mg~Dexamethasonehigh-dose: 15 mg"
793000|NCT01431014|E1|Reported Event|"DexamethasoneLow-dose"|"5mg~Dexamethasonelow-dose: 5mg"
793001|NCT01430819|B3|Baseline|Total|Total of all reporting groups
793002|NCT01430819|B2|Baseline|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
793003|NCT01430819|B1|Baseline|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
793004|NCT01430819|P2|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.
793005|NCT01430819|P1|Participant Flow|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
793006|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
793007|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
793008|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
793009|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
793010|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
793011|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
793012|NCT01430819|O2|Outcome|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
793013|NCT01430819|O1|Outcome|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
793014|NCT01430819|E2|Reported Event|Fluzone® High-Dose Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
793015|NCT01430819|E1|Reported Event|Fluzone® Vaccine Group|Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
793016|NCT01430754|B4|Baseline|Total|Total of all reporting groups
793017|NCT01430754|B3|Baseline|Placebo (Randomized)|"Placebo capsules~Placebo: Placebo capsules, daily"
793018|NCT01430754|B2|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793019|NCT01430754|B1|Baseline|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
793020|NCT01430754|P2|Participant Flow|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793021|NCT01430754|P1|Participant Flow|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793022|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793023|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793024|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793025|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793026|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793027|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793028|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793029|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793030|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793031|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793032|NCT01430754|O2|Outcome|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793033|NCT01430754|O1|Outcome|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793034|NCT01430754|E4|Reported Event|Placebo|"Placebo capsules~Placebo: Placebo capsules, daily"
793035|NCT01430754|E3|Reported Event|Tasimelteon|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793036|NCT01430754|E2|Reported Event|Run-In - Not Randomized|"20 mg tasimelteon capsules~tasimelteon: 20 mg capsules, daily"
793037|NCT01430754|E1|Reported Event|Total Run-In|"20 mg tasimelteon capsules~tasimelteon: 20 mg tasimelteon capsules, daily"
793038|NCT01430741|B5|Baseline|Total|Total of all reporting groups
793039|NCT01430741|B4|Baseline|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
793040|NCT01430741|B3|Baseline|Enhanced Implementation Approach GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793041|NCT01430741|B2|Baseline|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans."
793042|NCT01430741|B1|Baseline|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793043|NCT01430741|P4|Participant Flow|GTO MISSION Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
793044|NCT01430741|P3|Participant Flow|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793063|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
793348|NCT01429532|P2|Participant Flow|Group II|2.2-mm-incision-size phacoemulsification system
793354|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
793045|NCT01430741|P2|Participant Flow|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793046|NCT01430741|P1|Participant Flow|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793047|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
793048|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793049|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793050|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793051|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
793052|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793053|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793054|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793055|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
793056|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793057|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793058|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793059|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
793060|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793061|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793062|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793349|NCT01429532|P1|Participant Flow|Group I|1.8-mm-incision-size phacoemulsification system
793064|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793065|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793066|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793067|NCT01430741|O4|Outcome|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans.
793068|NCT01430741|O3|Outcome|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793069|NCT01430741|O2|Outcome|MISSION-Vet IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793070|NCT01430741|O1|Outcome|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793071|NCT01430741|E4|Reported Event|GTO Veterans|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform, while delivering MISSION services to Veterans
793072|NCT01430741|E3|Reported Event|GTO Case Management|Getting To Outcomes (GTO) is used to strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. In GTO, staff receive ongoing technical assistance using the GTO implementation platform.
793073|NCT01430741|E2|Reported Event|MISSION-Vet - IU Veterans|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - staff receive standard training on the MISSION model via a 1.5 hour webinar and then deliver MISSION services to Veterans"
793074|NCT01430741|E1|Reported Event|MISSION-Vet - IU Case Management|"Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition):MISSION-Vet has been developed to target mental health, substance abuse and related issues faced by homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources.~Implementation as Usual (IU) - standard training on the MISSION model via a 1.5 hour webinar"
793075|NCT01430624|B4|Baseline|Total|Total of all reporting groups
793076|NCT01430624|B3|Baseline|Standard Care (Completing Baseline)|Standard Care Condition completing baseline
793077|NCT01430624|B2|Baseline|PIRI (Completing Baseline)|Pleasant Imagery and Relaxation Instruction
793078|NCT01430624|B1|Baseline|PPRS (Completing Baseline)|Prevention of Post-Sexual Assault Stress
793079|NCT01430624|P3|Participant Flow|Standard Care|Treatment as usual
793080|NCT01430624|P2|Participant Flow|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793081|NCT01430624|P1|Participant Flow|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793082|NCT01430624|O3|Outcome|Standard Care|Treatment as usual which included standard care
793083|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793084|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793085|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
793086|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793087|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793088|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
793089|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793090|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793091|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
793350|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
793092|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793093|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793094|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
793095|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793096|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793097|NCT01430624|O3|Outcome|SC Condition|Standard Care Completing Follow-up
793098|NCT01430624|O2|Outcome|PIRI|Pleasant Imagery and Relaxation Condition
793099|NCT01430624|O1|Outcome|PPRS|Prevention of Post-Sexual Assault Stress
793100|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
793101|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793102|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793103|NCT01430624|O3|Outcome|Standard Care|Treatment as usual
793104|NCT01430624|O2|Outcome|PIRI Video|"Pleasant imagery and relaxation instruction~PIRI: Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam."
793105|NCT01430624|O1|Outcome|PPRS Video|"Prevention of post sexual assault stress~PPRS: Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam."
793106|NCT01430624|E3|Reported Event|Standard Care Condition|Standard Care Condition
793107|NCT01430624|E2|Reported Event|PIRI|Pleasant Imagery and Relaxation Instruction
793108|NCT01430624|E1|Reported Event|PPRS|Prevention of Post-Sexual Assault Stress
793109|NCT01430611|B3|Baseline|Total|Total of all reporting groups
793110|NCT01430611|B2|Baseline|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793111|NCT01430611|B1|Baseline|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793112|NCT01430611|P2|Participant Flow|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793113|NCT01430611|P1|Participant Flow|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793114|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793115|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793116|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793117|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793118|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793119|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793120|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793121|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793122|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793123|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793124|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793125|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793126|NCT01430611|O2|Outcome|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793127|NCT01430611|O1|Outcome|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793128|NCT01430611|E2|Reported Event|Meng Ling Kang® (Group 2)|Children aged 2 to 6 years received a single dose of Lanzhou Institute of Biological Products Meningococcal A+C Polysaccharide Vaccine
793129|NCT01430611|E1|Reported Event|Meningo A+C® (Group 1)|Children aged 2 to 6 years received a single dose of Sanofi Pasteur Meningococcal A+C Polysaccharide Vaccine
793130|NCT01430585|B1|Baseline|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793351|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
793352|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
793131|NCT01430585|P1|Participant Flow|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793132|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793133|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793134|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793135|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793136|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793137|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793138|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793139|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793140|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793141|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793142|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793143|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793144|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793145|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793146|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793147|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793148|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793149|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793150|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793151|NCT01430585|O4|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793152|NCT01430585|O3|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793153|NCT01430585|O2|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793154|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793155|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793156|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793157|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793158|NCT01430585|O3|Outcome|Letrozole (Phase 2)|Letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793159|NCT01430585|O2|Outcome|PF-04691502 + Letrozole (Phase 2)|Combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793160|NCT01430585|O1|Outcome|PF-04691502, Then PF-04691502 + Letrozole (Phase 2)|PF-04691502 6 mg tablet orally once daily up to Week 2 followed by combination of PF-04691502 6 mg tablet and letrozole 2.5 mg tablet orally once daily up to Week 6 or 16 as per investigator’s discretion.
793161|NCT01430585|O1|Outcome|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793162|NCT01430585|E1|Reported Event|PF-04691502 + Letrozole (Phase 1B)|Letrozole 2.5 milligram (mg) tablet orally on Day 1 followed by PF-04691502 8 mg tablet orally once daily from Day 2 until Day 11 and then a combination of PF-04691502 8 mg tablet and letrozole 2.5 mg tablet orally once daily from Day 12 until progression of disease, occurrence of unacceptable toxicity or withdrawal of consent. Dose of PF-04691502 was reduced to 6 mg orally once daily based on preliminary safety analysis conducted in the first 7 participants evaluable for safety.
793163|NCT01430468|B3|Baseline|Total|Total of all reporting groups
793164|NCT01430468|B2|Baseline|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
793165|NCT01430468|B1|Baseline|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
793166|NCT01430468|P2|Participant Flow|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
793167|NCT01430468|P1|Participant Flow|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
793168|NCT01430468|O2|Outcome|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
793169|NCT01430468|O1|Outcome|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
793170|NCT01430468|E2|Reported Event|Standard Group|Each surgeon will use their standard methods of pre-operative planning using the pre-operative x-rays and CT scan.
793171|NCT01430468|E1|Reported Event|Glenoid Positioning System|"For the patients randomized to the GPS group, the surgeon will be given the GPS patient specific instrumentation and a model of the glenoid surface showing the exact placement and fit of the GPS alignment instruments.~Glenoid Positioning System: Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component"
793172|NCT01430403|B4|Baseline|Total|Total of all reporting groups
793173|NCT01430403|B3|Baseline|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
793174|NCT01430403|B2|Baseline|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
793175|NCT01430403|B1|Baseline|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
793176|NCT01430403|P3|Participant Flow|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
793177|NCT01430403|P2|Participant Flow|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
793178|NCT01430403|P1|Participant Flow|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
793179|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
793353|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
793180|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
793181|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793182|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793183|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793184|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793185|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793186|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793187|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793188|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793189|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793190|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793191|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793192|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793193|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793194|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793195|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793232|NCT01430325|P3|Participant Flow|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793196|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793197|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793198|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793199|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793200|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793201|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793202|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793203|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793204|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793205|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793206|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793207|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793208|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793209|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793210|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793211|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793233|NCT01430325|P2|Participant Flow|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793212|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793213|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
793214|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
793215|NCT01430403|O2|Outcome|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
793216|NCT01430403|O1|Outcome|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
793217|NCT01430403|O2|Outcome|Samples Without Exacerbations|These nasal mucus samples were not associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
793218|NCT01430403|O1|Outcome|Samples With Exacerbations|These nasal mucus samples were associated with an exacerbation (defined as a prescribed course of systemic steroids by a clinician or initiation of a course of systemic steroids by a participant or a hospitalization during the fall outcome period (90 day period beginning on the first day of the participant's school year) to prevent a serious asthma outcome. If a participant initiates and completes a course of systemic steroids without clinician involvement, this course will be counted only if it meets the following minimum dosage: prednisone, prednisolone, or methylprednisolone at >/= 20mg per day for 3 of any 5 consecutive days; or dexamethasone at >/= 10mg per day for >/= 1 day)
793219|NCT01430403|O2|Outcome|Treatment Steps 2-4:Inhaled Corticosteroid Boost Therapy (ICS)|Participants on the ICS arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793220|NCT01430403|O1|Outcome|Treatment Steps 2-4: Omalizumab|Participants on the omalizumab arm at Treatment Steps 2-4 at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793221|NCT01430403|O2|Outcome|Treatment Steps 2-5: Placebo|Participants on the placebo arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793222|NCT01430403|O1|Outcome|Treatment Steps 2-5: Omalizumab|Participants on the omalizumab arm across all treatment steps (2-5) at randomization. Six treatment steps were established, consistent with report 3 of the National Asthma Education and Prevention Program guidelines to standardize prescribing patterns according to levels of asthma severity. Steps 1 and 2 apply to mild asthma, Step 3 to moderate asthma, and Steps 4 through 5 to severe asthma.
793223|NCT01430403|E3|Reported Event|Placebo|Participants in the placebo group received placebo injection and placebo inhaler. All participants received standardized specialist asthma care.
793224|NCT01430403|E2|Reported Event|Inhaled Corticosteroid Boost Therapy (ICS)|Participants in the Inhaled Corticosteroid (ICS) boost arm received active ICS and placebo injections of omalizumab (Xolair(R)). Self-administered fluticasone (Flovent (R) Diskus) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone were used. All participants received standardized specialist asthma care.
793225|NCT01430403|E1|Reported Event|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
793226|NCT01430325|B5|Baseline|Total|Total of all reporting groups
793227|NCT01430325|B4|Baseline|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793228|NCT01430325|B3|Baseline|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793229|NCT01430325|B2|Baseline|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793230|NCT01430325|B1|Baseline|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793231|NCT01430325|P4|Participant Flow|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793338|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
793234|NCT01430325|P1|Participant Flow|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793235|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793236|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793237|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793238|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793239|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793240|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793241|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793242|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793243|NCT01430325|O4|Outcome|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793244|NCT01430325|O3|Outcome|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793245|NCT01430325|O2|Outcome|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793246|NCT01430325|O1|Outcome|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793247|NCT01430325|E4|Reported Event|Sea Level Equivalent 1.5 Atm Abs (O2)|"Sea Level Equivalent 1.5 atm abs (6.2 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793248|NCT01430325|E3|Reported Event|Sea Level Equivalent 1.2 Atm Abs (Air)|"Sea Level Equivalent 1.2 atm abs (2.6 psig) breathing regular air 20-chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793249|NCT01430325|E2|Reported Event|Altitude Equivalent 1.5 Atm Abs (O2)|"Altitude Equivalent 1.5 atm abs (9.6 psig) breathing 100% oxygen 20-minute chamber excursion~Hyperbaric Oxygen (1.5 atm abs) : Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs."
793250|NCT01430325|E1|Reported Event|Altitude Equivalent 1.2 Atm Abs (Air)|"Altitude Equivalent 1.2 atm abs (5.1 psig) breathing regular air 20-minute chamber excursion~Sham Chamber Session : Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs"
793251|NCT01430182|B3|Baseline|Total|Total of all reporting groups
793252|NCT01430182|B2|Baseline|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793253|NCT01430182|B1|Baseline|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793254|NCT01430182|P2|Participant Flow|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793255|NCT01430182|P1|Participant Flow|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793256|NCT01430182|O2|Outcome|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793257|NCT01430182|O1|Outcome|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793258|NCT01430182|E2|Reported Event|Morphine 0.2 mg/kg|"0.2 mg/kg morphine by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Morphine: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793339|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
793259|NCT01430182|E1|Reported Event|Methadone 0.2 mg/kg|"0.2 mg/kg methadone by actual body weight, administered over ten minutes, initiated after induction of anesthesia and endotracheal intubation complete.~Methadone: 0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete."
793260|NCT01430169|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793261|NCT01430169|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg (First Injection is administered on Day 1 and the second Injection is administered on Day 2)"
793262|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793263|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793264|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793265|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793266|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793267|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793268|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793269|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793270|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793271|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793272|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793273|NCT01430169|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793274|NCT01430169|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: Two injections of AA4500 0.58 mg"
793275|NCT01430130|B1|Baseline|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
793276|NCT01430130|P1|Participant Flow|All Study Participants|Half of the revised incision was treated with the embrace device. Half of the revised incision was treated according to the Investigator's standard of care. Participant served as his/her own control.
793277|NCT01430130|O2|Outcome|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
793278|NCT01430130|O1|Outcome|Treated Side|Half of the revised incision was treated with the embrace device.
793279|NCT01430130|E2|Reported Event|Control Side|Half of the revised incision was treated according to the investigator’s standard of care. Participant served as his own control.
793280|NCT01430130|E1|Reported Event|Treated Side|Half of the revised incision was treated with the embrace device.
793281|NCT01430104|B1|Baseline|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793282|NCT01430104|P1|Participant Flow|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793283|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793284|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and after the planned Teriparatide dose during the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793285|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793286|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793287|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793288|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide planned dose during 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793289|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the planned Teriparatide dose during the 14-day Lead-in Period and after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793290|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793291|NCT01430104|O1|Outcome|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793292|NCT01430104|E1|Reported Event|600 mg Aspara-CA + 1 µg Alfarol + 20 µg Teriparatide|Aspara-CA (600 milligrams [mg]) and Alfarol (1.0 microgram [µg]) were administered orally once daily after the Teriparatide dose during the 28-day Treatment Period and the 7-day Follow-up Period. Teriparatide (20 µg) was administered subcutaneously once daily for the 28-day Treatment Period.
793293|NCT01430091|B1|Baseline|Participants|Total Number of Study Participants
793294|NCT01430091|P1|Participant Flow|Participants|Received 5 milligrams (mg) prasugrel as either the clinical tablet or as an orally disintegrating tablet (ODT).
793295|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
793296|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
793297|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
793298|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating table (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
793299|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole approximately 180 milliliters (ml) with water.
793300|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
793301|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
793302|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
793303|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
793304|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
793305|NCT01430091|O5|Outcome|ODT Placed Under the Tongue|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
793306|NCT01430091|O4|Outcome|ODT Chewed and Swallowed|5-mg prasugrel ODT chewed and swallowed, no liquid given.
793307|NCT01430091|O3|Outcome|ODT on Top of Tongue With Juice Chaser|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
793308|NCT01430091|O2|Outcome|ODT on Top of Tongue|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
793309|NCT01430091|O1|Outcome|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
793310|NCT01430091|E5|Reported Event|ODT (Under Tongue)|5-mg prasugrel ODT placed under the tongue and allowed to disintegrate, no liquid given.
793311|NCT01430091|E4|Reported Event|ODT (Chew and Swallow)|5-mg prasugrel ODT chewed and swallowed, no liquid given.
793312|NCT01430091|E3|Reported Event|ODT (Juice Chaser)|5-mg prasugrel ODT placed on the tongue and allowed to disintegrate, followed by approximately 180 milliliters (ml) apple juice chaser.
793313|NCT01430091|E2|Reported Event|ODT (Top of Tongue)|5-mg prasugrel orally disintegrating tablet (ODT) placed on the tongue and allowed to disintegrate, no liquid given.
793314|NCT01430091|E1|Reported Event|Clinical Tablet|5-milligrams (mg) prasugrel clinical tablet swallowed whole with approximately 180 milliliters (ml) water.
793315|NCT01429623|B3|Baseline|Total|Total of all reporting groups
793316|NCT01429623|B2|Baseline|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
793317|NCT01429623|B1|Baseline|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
793318|NCT01429623|P2|Participant Flow|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
793319|NCT01429623|P1|Participant Flow|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
793320|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
793321|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
793322|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
793323|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
793324|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
793325|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
793326|NCT01429623|O2|Outcome|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
793327|NCT01429623|O1|Outcome|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
793328|NCT01429623|E2|Reported Event|Placebo Control|"drug product excipients~Placebo: Placebo comparator"
793329|NCT01429623|E1|Reported Event|Ladostigil Hemitartrate|"10mg ladostigil base~ladostigil hemitartrate: 10mg ladostigil base administered once daily as hard gelatin capsule"
793330|NCT01429584|B3|Baseline|Total|Total of all reporting groups
793331|NCT01429584|B2|Baseline|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
793332|NCT01429584|B1|Baseline|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
793333|NCT01429584|P2|Participant Flow|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
793334|NCT01429584|P1|Participant Flow|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
793335|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
793336|NCT01429584|O1|Outcome|0.25% Bupivacaine|interscalene nerve block with 0.25% bupivacaine
793337|NCT01429584|O2|Outcome|0.125% Bupivacaine|interscalene nerve block with 0.125% bupivacaine
793356|NCT01429532|O3|Outcome|Group III|3.0-mm-incision-size phacoemulsification system
793357|NCT01429532|O2|Outcome|Group II|2.2-mm-incision-size phacoemulsification system
793358|NCT01429532|O1|Outcome|Group I|1.8-mm-incision-size phacoemulsification system
793359|NCT01429532|E3|Reported Event|Group III|3.0-mm-incision-size phacoemulsification system
793360|NCT01429532|E2|Reported Event|Group II|2.2-mm-incision-size phacoemulsification system
793361|NCT01429532|E1|Reported Event|Group I|1.8-mm-incision-size phacoemulsification system
793362|NCT01429441|B3|Baseline|Total|Total of all reporting groups
793363|NCT01429441|B2|Baseline|Sham|Subjects in the sham group received a single sham injection
793364|NCT01429441|B1|Baseline|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
793365|NCT01429441|P2|Participant Flow|Sham|Subjects in the sham group received a single sham injection
793366|NCT01429441|P1|Participant Flow|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
793367|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
793368|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
793369|NCT01429441|O2|Outcome|Sham|Subjects in the sham group received a single sham injection
793370|NCT01429441|O1|Outcome|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
793371|NCT01429441|E2|Reported Event|Sham|Subjects in the sham group received a single sham injection
793372|NCT01429441|E1|Reported Event|Ocriplasmin|Subjects in the ocriplasmin group received a single intravitreal injection of ocriplasmin 0.125mg
793373|NCT01429259|B1|Baseline|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
793374|NCT01429259|P1|Participant Flow|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
793375|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
793376|NCT01429259|O1|Outcome|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
793377|NCT01429259|E1|Reported Event|Meropenem 3 Hour Prolonged Infusion|"All 30 participants will receive meropenem as a 3 hour infusion.~meropenem: meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion."
793378|NCT01429077|B3|Baseline|Total|Total of all reporting groups
793379|NCT01429077|B2|Baseline|Inactive Pill|
793380|NCT01429077|B1|Baseline|Levodopa|
793381|NCT01429077|P2|Participant Flow|Inactive Pill|The inactive pill was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
793382|NCT01429077|P1|Participant Flow|Levodopa|The study drug (100 mg levodopa / 25 mg carbidopa), was received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
793383|NCT01429077|O2|Outcome|Inactive Pill|
793384|NCT01429077|O1|Outcome|Levodopa/Carbidopa|
793385|NCT01429077|E2|Reported Event|Inactive Pill|
793386|NCT01429077|E1|Reported Event|Levodopa|
793387|NCT01429064|B5|Baseline|Total|Total of all reporting groups
793388|NCT01429064|B4|Baseline|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793389|NCT01429064|B3|Baseline|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793390|NCT01429064|B2|Baseline|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793391|NCT01429064|B1|Baseline|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
793392|NCT01429064|P4|Participant Flow|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793393|NCT01429064|P3|Participant Flow|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793394|NCT01429064|P2|Participant Flow|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793395|NCT01429064|P1|Participant Flow|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
793396|NCT01429064|O4|Outcome|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793397|NCT01429064|O3|Outcome|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793398|NCT01429064|O2|Outcome|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793399|NCT01429064|O1|Outcome|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
793400|NCT01429064|E4|Reported Event|Patients From Arades 3104001 Dose Expansion (1400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793545|NCT01428076|E1|Reported Event|Polidocanol 1%|polidocanol injectable foam 1% concentration
793401|NCT01429064|E3|Reported Event|Patients From Arades 3104001 Dose Expansion (400mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793402|NCT01429064|E2|Reported Event|Patients From Arades 3104001 Dose Expansion (200mg/Day)|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor.
793403|NCT01429064|E1|Reported Event|Patients From Arades 3104001 Dose Escalation|200 mg/day, 400 mg/day, 600 mg/day, 1000 mg/day, 1400 mg/day, 1800 mg/day
793404|NCT01429051|B1|Baseline|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
793405|NCT01429051|P1|Participant Flow|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
793406|NCT01429051|O3|Outcome|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
793407|NCT01429051|O2|Outcome|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
793408|NCT01429051|O1|Outcome|Titration Phase|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase.
793409|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
793410|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
793411|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
793412|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
793413|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
793414|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
793415|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
793416|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
793417|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
793418|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
793419|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|All participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I). Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence. Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
793420|NCT01429051|O2|Outcome|Placebo|In the Efficacy Phase Participants received placebo intranasal spray for 2 episodes of breakthrough pain.
793421|NCT01429051|O1|Outcome|Intranasal Fentanyl Spray (INFS)|In the Efficacy phase participants received 400 μg INFS for 6 episodes of breakthrough pain.
793422|NCT01429051|E3|Reported Event|Tolerability Phase|Participants entered the Tolerability Phase (III) either directly from the Titration Phase (with an effective dose of 50 or 100 μg) or from the Efficacy Phase (400 μg) and continued with this specific dose, unless adjustment was needed, for a total treatment time of 12 weeks.
793423|NCT01429051|E2|Reported Event|Efficacy Phase|Participants titrated to 200 or 400 μg INFS in the Titration Phase were randomized to an 8-spray sequence in the Efficacy Phase (II); 6 BTP episodes were treated with 400 μg INFS and 2 BTP episodes with placebo in a random sequence.
793424|NCT01429051|E1|Reported Event|Titration Phase|Participants were step-wise titrated to an effective dose of 50, 100, 200 or 400 μg INFS in the Titration Phase (I).
793425|NCT01428882|B3|Baseline|Total|Total of all reporting groups
793426|NCT01428882|B2|Baseline|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793427|NCT01428882|B1|Baseline|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793428|NCT01428882|P2|Participant Flow|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793546|NCT01428063|B4|Baseline|Total|Total of all reporting groups
794125|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
793705|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793429|NCT01428882|P1|Participant Flow|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793430|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793431|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793432|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793433|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793434|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793435|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793436|NCT01428882|O2|Outcome|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793437|NCT01428882|O1|Outcome|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793438|NCT01428882|E2|Reported Event|Single-agent Propofol Sedation|"2 ml saline followed by continuous propofol iv infusion~Propofol: Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793439|NCT01428882|E1|Reported Event|Midazolam Balanced Propofol Sedation|"2 mg midazolam in 2 ml saline midazolam followed by continuous propofol iv infusion~Midazolam: Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level"
793440|NCT01428765|B1|Baseline|All Patients|
793441|NCT01428765|P1|Participant Flow|All Patients|
793442|NCT01428765|O1|Outcome|All Patients|
793443|NCT01428765|O1|Outcome|All Patients|
793444|NCT01428765|O1|Outcome|All Patients|
793445|NCT01428765|O1|Outcome|All Patients|
793446|NCT01428765|O1|Outcome|All Patients|
793447|NCT01428765|O1|Outcome|All Patients|
793448|NCT01428765|O1|Outcome|All Patients|
793449|NCT01428765|O1|Outcome|All Patients|
793450|NCT01428765|E1|Reported Event|All Patients|
793451|NCT01428713|B1|Baseline|All Study Participants|"Group A: TA first, then COCP:~Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP.~Group B: COCP first, then TA:~Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP.~Subsequently, patients who initially received COCP, received TA."
793452|NCT01428713|P2|Participant Flow|Group B: COCP First, Then TA|"Patients received COCP first. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between COCP and TA.~Subsequently, patients who initially received COCP, received TA. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles."
793453|NCT01428713|P1|Participant Flow|Group A: TA First, Then COCP|"Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP. COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between TA and COCP."
793454|NCT01428713|O2|Outcome|Group: COCP|Patients received COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles.
793455|NCT01428713|O1|Outcome|Group: TA|Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.
793508|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
793456|NCT01428713|E2|Reported Event|Combined Oral Contraceptives (COCP)|COCP formulation Lo/Ovral (components: Ethinyl estradiol 30 mcg and norgestrel 0.3 mg; each monthly pack containing 21 hormonal tablets and 7 inactive tablets). Patients received COCP with 3 weeks of hormonal pills and 1 week of placebo pills for 3 consecutive cycles. Each medication was prescribed for 3 menstrual cycles with a 1 month wash out in-between medications.
793457|NCT01428713|E1|Reported Event|Tranexamic Acid (TA)|"Patients received oral tranexamic acid at 1300 mg three times each day on days 1 to 5 of menstrual cycle for 3 cycles. The mean age of the study population was 14.2 years. Patients received oral TA (given according to US FDA label for adult women, an off-label use for adolescents <18 years of age) at 1300 mg (two 650mg tablets) three times each day on days 1 to 5 of menstrual cycle for 3 consecutive cycles.~Subsequently, patients who initially received TA, received COCP and patients who initially received COCP, then received TA."
793458|NCT01428661|B4|Baseline|Total|Total of all reporting groups
793459|NCT01428661|B3|Baseline|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
793460|NCT01428661|B2|Baseline|Placebo|Placebo capsules, PO daily for 8 weeks
793461|NCT01428661|B1|Baseline|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
793462|NCT01428661|P3|Participant Flow|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
793463|NCT01428661|P2|Participant Flow|Placebo|Placebo capsules, PO daily for 8 weeks
793464|NCT01428661|P1|Participant Flow|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
793465|NCT01428661|O3|Outcome|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
793466|NCT01428661|O2|Outcome|Placebo|Placebo capsules, PO daily for 8 weeks
793467|NCT01428661|O1|Outcome|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
793468|NCT01428661|E3|Reported Event|Open Label Tasimelteon|20 mg capsules, PO daily for 52 weeks
793469|NCT01428661|E2|Reported Event|Placebo|Placebo capsules, PO daily for 8 weeks
793470|NCT01428661|E1|Reported Event|Tasimelteon|20 mg tasimelteon capsules, PO daily for 8 weeks
793471|NCT01428583|B1|Baseline|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793472|NCT01428583|P1|Participant Flow|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793473|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793474|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793475|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793476|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793477|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793478|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793509|NCT01428258|O1|Outcome|GMP Diet|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
793479|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793480|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793481|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793482|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793483|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793484|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793485|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793486|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793487|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793488|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793489|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793490|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793510|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
793588|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
793491|NCT01428583|O1|Outcome|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793492|NCT01428583|E1|Reported Event|Oxycodone Hydrochloride (HCl) and Naltrexone HCl|Participants received oxycodone HCl and naltrexone HCl extended-release capsules at an allowable total daily dose range of 20 milligram (mg) oxycodone HCl /2.4 mg naltrexone HCl to 160 mg oxycodone HCl /19.2 mg naltrexone HCl, once daily or twice daily, as per investigators’ discretion, for 12 months. Following Month 12, dose might be tapered from the current total daily dose of oxycodone HCl and naltrexone HCl extended-release capsules to the Investigator-determined standard of care based on investigator’s discretion.
793493|NCT01428258|B3|Baseline|Total|Total of all reporting groups
793494|NCT01428258|B2|Baseline|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.~Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
793495|NCT01428258|B1|Baseline|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.~Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
793496|NCT01428258|P2|Participant Flow|AA Diet - GMP Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the AA diet followed by the GMP diet referred to as the Amino Acid (AA) Diet given first intervention.~Amino Acid (AA) Diet Given First: The intervention compares the usual amino acid (AA) low-phenylalanine (phe) dietary therapy with a new dietary therapy for PKU, a low-phe diet containing foods and beverages made from glycomacropeptide (GMP). PKU subjects in the AA Diet-GMP Diet Arm will follow their usual AA diet for 3 weeks followed by a 3 wk wash out period. They will then replace all of the protein equivalents provided in their diet by AA formula with foods and beverages made from GMP using Glytactin as provided by Cambrooke Foods, LLC. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
793497|NCT01428258|P1|Participant Flow|GMP Diet-AA Diet|"In this randomized crossover study, half of subjects will be assigned to an arm that consists of the the GMP diet followed by the AA diet referred to as the Glycomacropeptide (GMP) diet given first intervention.~Glycomacropeptide (GMP) diet given first: The intervention compares a new low-phenylalanine (phe) dietary therapy for PKU, a diet containing foods and beverages made from GMP using Glytactin provided by Cambrooke Foods LLC, with the usual amino acid (AA) low-phe dietary therapy. PKU subjects in the GMP Diet-AA Diet Arm will follow the GMP diet that will replace all of the dietary protein equivalents provided by AA formula with foods and beverages made from GMP for 3 weeks followed by a 3 wk wash out period. They will then follow the usual AA diet for 3 weeks. Each dietary treatment period will maintain constant intake of total protein and phe and last for 3 weeks in subjects living at home."
793498|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
793499|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention administered as the first or second dietary treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
793500|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
793501|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made with glycomacropeptide.
793502|NCT01428258|O2|Outcome|Phe Concentration in Dried Blood Spots, Tandem Mass Spec|Subjects spotted their blood on filter paper at the same time as plasma was obtained at 3 or 4 time periods, dried blood spots were obtained, and analyzed for Phe concentration using tandem mass spectrometry.
793503|NCT01428258|O1|Outcome|Phe Concentration in Plasma, Ion Exchange Chromatography|Blood was collected by venipuncture at 3 to 4 time points, plasma was isolated and the concentration of Phe was determined by ion exchange chromatography.
793504|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
793505|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
793506|NCT01428258|O2|Outcome|AA Diet/AA Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with each subjects usual AA medical foods.
793507|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|The intervention followed as the first or second treatment consists of a low-Phe diet in combination with medical foods made from glycomacropeptide .
793544|NCT01428076|E2|Reported Event|Polidocanol 2%|polidocanol injectable foam 2% concentration
793511|NCT01428258|O1|Outcome|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
793512|NCT01428258|E2|Reported Event|AA Diet/AA Medical Foods|All subjects received the Amino Acid (AA) Diet in either the first or second period. The intervention consists of a low-Phe diet in combination with each subject's usual AA medical formula.
793513|NCT01428258|E1|Reported Event|GMP Diet/GMP Medical Foods|All subjects received the Glycomacropeptide (GMP) diet either in the first or second period. The intervention consists of a low-Phe diet in combination with medical foods made from glycomacropeptide, a low-Phe whey protein.
793514|NCT01428219|B1|Baseline|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
793515|NCT01428219|P1|Participant Flow|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
793516|NCT01428219|O1|Outcome|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
793517|NCT01428219|E1|Reported Event|Cabozantinib (XL184)|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
793518|NCT01428128|B1|Baseline|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
793519|NCT01428128|P1|Participant Flow|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
793520|NCT01428128|O1|Outcome|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
793521|NCT01428128|E1|Reported Event|Arsenic Trioxide|Arsenic Trioxide: IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
793522|NCT01428115|B1|Baseline|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793523|NCT01428115|P1|Participant Flow|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793524|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793525|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793526|NCT01428115|O1|Outcome|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793527|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793528|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793529|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793530|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793531|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793532|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793533|NCT01428115|O1|Outcome|Adalimumab|Participants received 40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793534|NCT01428115|E1|Reported Event|Adalimumab|40 mg every other week via subcutaneous injection according to Summary of Product Characteristics (SmPC)
793535|NCT01428076|B3|Baseline|Total|Total of all reporting groups
793536|NCT01428076|B2|Baseline|Polidocanol 2%|polidocanol intravenous foam 2% concentration
793537|NCT01428076|B1|Baseline|Polidocanol 1%|polidocanol injectable foam 1% concentration
793538|NCT01428076|P2|Participant Flow|Polidocanol 2%|polidocanol injectable foam 2% concentration
793539|NCT01428076|P1|Participant Flow|Polidocanol 1%|polidocanol injectable foam 1% concentration
793540|NCT01428076|O4|Outcome|Females- Polidocanol 2%|polidocanol injectable foam 2% concentration
793541|NCT01428076|O3|Outcome|Females-polidocanol 1%|polidocanol injectable foam 1% concentration
793542|NCT01428076|O2|Outcome|Males-polidocanol 2%|polidocanol injectable foam 2% concentration
793543|NCT01428076|O1|Outcome|Males-polidocanol 1%|polidocanol injectable foam 1% concentration
793547|NCT01428063|B3|Baseline|Daclatasvir + pegIFN-2a+ Ribavirin|Patients received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
793548|NCT01428063|B2|Baseline|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
793549|NCT01428063|B1|Baseline|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
793550|NCT01428063|P3|Participant Flow|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793551|NCT01428063|P2|Participant Flow|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule or 200-mg tablet, by mouth twice daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
793552|NCT01428063|P1|Participant Flow|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks
793553|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793554|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
793555|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
793556|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793557|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793558|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793559|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793560|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793561|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
793562|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793563|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
793564|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
793565|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793566|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793587|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793567|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793568|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793569|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793570|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
793571|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793572|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
793573|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
793574|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793575|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793576|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793577|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793578|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793579|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
793580|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793581|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
793582|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
793583|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793584|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793585|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793586|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793589|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793590|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
793591|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
793592|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793593|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793594|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793595|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793596|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793597|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
793598|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received DCV, 60 mg tablet, by mouth once daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793599|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
793600|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
793601|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793602|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC)/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793603|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793604|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793605|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin|Participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793606|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
793607|NCT01428063|O9|Outcome|DCV + pegIFN-2a+ RBV|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793608|NCT01428063|O8|Outcome|DCV + ASV + pegIFN-2a+ RBV (pegIFNα /RBV Relapsers)|pegIFNα /RBV relapsers were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 week.
793609|NCT01428063|O7|Outcome|DCV + ASV + pegIFN-2a+ RBV (Treatment Naive)|HCV GT-1a infection treatment-naive participants were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 12 weeks.
793610|NCT01428063|O6|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior TVR Failures)|Participants who were nor responders to earlier telaprevir (TVR) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793611|NCT01428063|O5|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior BOC Failures)|Participants who were nor responders to earlier boceprevir(BOC) /pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793612|NCT01428063|O4|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior ASV Failures)|Participants who were nor responders to earlier ASV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793613|NCT01428063|O3|Outcome|DCV + ASV + pegIFN-2a+ RBV (Prior DCV Failures)|Participants who were nor responders to earlier DCV/pegIFN/RBV therapy were administered with DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegIFNα2a, 80 μg solution, subcutaneously weekly + RBV, weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793614|NCT01428063|O2|Outcome|DCV + ASV + pegIFN-2a+ Ribavirin (Genotype 4)|Genotype 4 participants received DCV, 60 mg tablet, by mouth once daily + ASV,100 mg capsule or 200 mg tablet, by mouth twice daily + pegylated interferon alfa-2a(pegIFNα2a), 80 μg solution, subcutaneously weekly + ribavirin (RBV), weight based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793615|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir|Participants received daclatasvir (DCV), 60 mg tablet, by mouth once daily + asunaprevir (ASV), 100 mg capsule, by mouth twice daily for 24 weeks.
793616|NCT01428063|O1|Outcome|Daclatasvir + Asunaprevir + PegIFNα-2a + Ribavirin (NR)|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
793617|NCT01428063|E3|Reported Event|Daclatasvir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet, by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks
793618|NCT01428063|E2|Reported Event|Daclatasvir + Asunaprevir + pegIFN-2a+ Ribavirin|Participants received daclatasvir, 60-mg tablet by mouth once daily + pegIFNα-2a, 180-μg solution, subcutaneously weekly for 24 weeks + ribavirin, weight-based dosing (<75 kg=1000 mg once daily; >=75 kg=1200 mg once daily) for 24 weeks.
793619|NCT01428063|E1|Reported Event|Daclatasvir + Asunaprevir|Participants received daclatasvir, 60-mg tablet, by mouth once daily + asunaprevir, 100-mg capsule, by mouth twice daily for 24 weeks.
793620|NCT01427933|B3|Baseline|Total|Total of all reporting groups
793621|NCT01427933|B2|Baseline|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793622|NCT01427933|B1|Baseline|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793623|NCT01427933|P2|Participant Flow|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793624|NCT01427933|P1|Participant Flow|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793625|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793626|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793627|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793628|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793629|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793630|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793631|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793632|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793633|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793634|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793635|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793636|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 milligrams/kilogram (mg/kg) administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 milligrams/square meter (mg/m²) administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793637|NCT01427933|O2|Outcome|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793638|NCT01427933|O1|Outcome|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793639|NCT01427933|E2|Reported Event|Eribulin Monotherapy|Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle
793640|NCT01427933|E1|Reported Event|Ramucirumab and Eribulin|"Ramucirumab (IMC-1121B) 10 mg/kg administered by intravenous (IV) infusion on Day 1 of each 3-week cycle~Eribulin 1.4 mg/m² administered by IV bolus on Day 1 and Day 8 of each 3-week cycle"
793641|NCT01427920|B3|Baseline|Total|Total of all reporting groups
793642|NCT01427920|B2|Baseline|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793643|NCT01427920|B1|Baseline|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793644|NCT01427920|P2|Participant Flow|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793645|NCT01427920|P1|Participant Flow|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793646|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793647|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793648|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793649|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793700|NCT01427751|B2|Baseline|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793770|NCT01427504|O1|Outcome|Boceprevir C8 Coadministered With Etravirine|Geometric mean ratio of boceprevir C8 when coadministered with etravirine
793650|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793651|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793652|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793653|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793654|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793655|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793656|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793657|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793658|NCT01427920|O2|Outcome|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793701|NCT01427751|B1|Baseline|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793771|NCT01427504|O1|Outcome|Boceprevir Cmax Coadministered With Etravirine|Geometric mean ratio of boceprevir Cmax when coadministered with etravirine
793659|NCT01427920|O1|Outcome|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793660|NCT01427920|E2|Reported Event|Investigator-driven|The investigator performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793661|NCT01427920|E1|Reported Event|Subject-driven|The subjects performed the titration of biphasic insulin aspart 30 (BIAsp 30) dose and administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. The starting dose of BIAsp 30 was subject’s previous basal insulin analogue dose split into two equal daily doses, immediately before breakfast and immediately before dinner. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued. Metformin was allowed to be continued at the pre-trial dose with a total daily dose of at least 1500 mg or maximum tolerated dose (minimum 1000 mg) as prior to randomisation.
793662|NCT01427907|B3|Baseline|Total|Total of all reporting groups
793663|NCT01427907|B2|Baseline|Sequence II: Sevelamer Then COS|Sevelamer Carbonate for 4 weeks then Calcium Acetate Oral Solution for 4 weeks
793664|NCT01427907|B1|Baseline|Sequence I: COS Then Sevelamer|Sequence I: Calcium Acetate Oral Solution for 4 weeks then Sevelamer Carbonate for 4 weeks
793665|NCT01427907|P2|Participant Flow|Sequence II: Sevelamer (4 Weeks) Then COS (4 Weeks)|Patient receive Sevelamer tablets for 4 weeks, then cross over to take COS for 4 weeks.
793666|NCT01427907|P1|Participant Flow|Sequence I: COS (4 Weeks) Then Sevelamar (4 Weeks)|Patient receive Calcium Acetate Oral Solution (COS) for 4 weeks then cross over to Sevelamer tablets for 4 weeks.
793667|NCT01427907|O2|Outcome|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
793668|NCT01427907|O1|Outcome|Calcium Acetate Oral Solution|Calcium Acetate Oral Solution for periods 1 and 2
793669|NCT01427907|E2|Reported Event|Sevelamer Carbonate|Sevelamer Carbonate for periods 1 and 2
793670|NCT01427907|E1|Reported Event|Calcium Acetate Oral Solution|Sequence I: Calcium Acetate Oral Solution for periods 1 and 2
793671|NCT01427881|B1|Baseline|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793672|NCT01427881|P1|Participant Flow|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793673|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793674|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793675|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793676|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793677|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793678|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793679|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793680|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793681|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793702|NCT01427751|P2|Participant Flow|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793703|NCT01427751|P1|Participant Flow|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793704|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
794906|NCT01422720|E1|Reported Event|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
793682|NCT01427881|O1|Outcome|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793683|NCT01427881|E1|Reported Event|Treatment (TBI, PBSCT, and Cyclophosphamide GVHD Prophylaxis)|"PREPARATIVE REGIMEN: Patients receive TBI BID on days -4 or -3 to -1. Some patients also receive fludarabine IV daily on days -5 to -2 and busulfan IV over 3 hours QD or over 2 hours every 6 hours on days -5 to -2. Patients may also undergo CNS prophylaxis, testicular irradiation, and/or involved field irradiation as per standard practice.~TRANSPLANTATION: Patients undergo allogeneic PBSCT on day 0 per standard practice.~GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 1-2 hours on days 3-4. Patients also receive cyclosporine IV every 12 hours or every 8 hours beginning on day 5 with taper on days 56-126.~cyclophosphamide: Given IV~cyclosporine: Given IV~peripheral blood stem cell transplantation: Undergo allogeneic PBSCT~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~busulfan: Given IV~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic PBSCT"
793684|NCT01427803|B3|Baseline|Total|Total of all reporting groups
793685|NCT01427803|B2|Baseline|Reasons for Misuse Interviewed Population|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
793686|NCT01427803|B1|Baseline|Patterns of Use User Population|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
793687|NCT01427803|P2|Participant Flow|Reasons for Misuse Cohort|A subject was included in the Reasons for Misuse Interviewed Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Reasons for Misuse Cohort, misused on one or more occasions (did not comply with the label directions [took more than one tablet per dose or a subsequent dose less than 22 hours later]), and completed the reasons for misuse questions.
793688|NCT01427803|P1|Participant Flow|Patterns of Use Cohort|A subject was included in the Patterns of Use User Population if he/she completed the enrollment interview, purchased the investigational product, was randomized into the Patterns of Use Cohort, and provided e-diary data regarding their use.
793689|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793690|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793691|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793692|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793693|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793694|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793695|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793696|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793697|NCT01427803|O1|Outcome|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793698|NCT01427803|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|Subjects were allowed to purchase a maximum of two bottles of Naproxen Sodium ER during their participation in the trial. The package instructed subjects to take one tablet every 24 hours while symptoms lasted for no more than 10 consecutive days for pain and no more than three consecutive days for fever.
793699|NCT01427751|B3|Baseline|Total|Total of all reporting groups
794907|NCT01422538|B4|Baseline|Total|Total of all reporting groups
793706|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793707|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793708|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793709|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793710|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793711|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793712|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793713|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793714|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793715|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793716|NCT01427751|O2|Outcome|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793717|NCT01427751|O1|Outcome|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793718|NCT01427751|E2|Reported Event|Lucentis®|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Participants will receive additional treatment thereafter based on re-treatment criteria.
793719|NCT01427751|E1|Reported Event|Ozurdex®|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Participants may receive up to one additional treatment, thereafter.
793720|NCT01427738|B3|Baseline|Total|Total of all reporting groups
793721|NCT01427738|B2|Baseline|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793722|NCT01427738|B1|Baseline|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793723|NCT01427738|P2|Participant Flow|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793724|NCT01427738|P1|Participant Flow|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793725|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793726|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793727|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793728|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793729|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793730|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793731|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793732|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793733|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793772|NCT01427504|O1|Outcome|Boceprevir AUC Coadministered With Etravirine|Geometric mean ratio of boceprevir AUC when coadministered with etravirine
793734|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793735|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793736|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793737|NCT01427738|O2|Outcome|Arm B: Nystatin Oral Suspension|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793738|NCT01427738|O1|Outcome|Arm A: Topical GV Solution|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793739|NCT01427738|E2|Reported Event|Nystatin|"Nystatin oral suspension (5 mL of 100,000 units/mL swish for 1 minute and swallow 4 times per day [QID]) for 14 days~Nystatin oral suspension: Participants will be administered Nystatin oral suspension 4 times a day for 14 days."
793740|NCT01427738|E1|Reported Event|Gentian Violet|"Topical GV 0.00165% solution (5 mL swish and gargle for 1 minute and expectorate [spit] 2 times per day [BID]) for 14 days~Gentian Violet: Participants will be administered topical Gentian violet solution, orally, twice daily for 14 days."
793741|NCT01427517|B4|Baseline|Total|Total of all reporting groups
793742|NCT01427517|B3|Baseline|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
793743|NCT01427517|B2|Baseline|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
793744|NCT01427517|B1|Baseline|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
793745|NCT01427517|P3|Participant Flow|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
793746|NCT01427517|P2|Participant Flow|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
793747|NCT01427517|P1|Participant Flow|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
793748|NCT01427517|O3|Outcome|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
793749|NCT01427517|O2|Outcome|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
793750|NCT01427517|O1|Outcome|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
793751|NCT01427517|E3|Reported Event|NAC in Controls|single intravenous administration of N-acetylcysteine in control subjects
793752|NCT01427517|E2|Reported Event|NAC in GD|single intravenous administration of N-acetylcysteine in GD patients
793753|NCT01427517|E1|Reported Event|NAC in PD|single intravenous administration of N-acetylcysteine in PD patients
793754|NCT01427504|B7|Baseline|Total|Total of all reporting groups
793755|NCT01427504|B6|Baseline|Sequence 3b|Sequence 3,2,1: Both boceprevir and etravirine, then etravirine only, then boceprevir only.
793756|NCT01427504|B5|Baseline|Sequence 3a|Sequence 3,1,2: both boceprevir and etravirine, then boceprevir only, then etravirine only.
793757|NCT01427504|B4|Baseline|Sequence 2b|Sequence 2,3,1: etravirine only, then both boceprevir and etravirine, then boceprevir only.
793758|NCT01427504|B3|Baseline|Sequence 2a|Sequence 2,1,3: etravirine only, then boceprevir only, then both boceprevir and etravirine.
793759|NCT01427504|B2|Baseline|Sequence 1b|Sequence 1,3,2: boceprevir only, then both boceprevir and etravirine, then etravirine only.
793760|NCT01427504|B1|Baseline|Sequence 1a|Sequence 1,2,3: boceprevir only, then etravirine only, then both boceprevir and etravirine.
793761|NCT01427504|P6|Participant Flow|Sequence 3b|Sequence 3,2,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
793762|NCT01427504|P5|Participant Flow|Sequence 3a|Sequence 3,1,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
793763|NCT01427504|P4|Participant Flow|Sequence 2b|Sequence 2,3,1: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
793764|NCT01427504|P3|Participant Flow|Sequence 2a|Sequence 2,1,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
793765|NCT01427504|P2|Participant Flow|Sequence 1b|Sequence 1,3,2: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
793766|NCT01427504|P1|Participant Flow|Sequence 1a|Sequence 1,2,3: boceprevir 800 mg three times daily alone, then etravirine 200 mg twice daily only, then both boceprevir 800 mg three times daily and etravirine 200 mg twice daily were each given for 11-14 days. Each intervention was followed by a 14 day washout period before the next sequence was started.
793767|NCT01427504|O1|Outcome|Etravirine Cmin Coadministered With Boceprevir|Geometric mean ratio of etravirine Cmin when coadministered with boceprevir
793768|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean ratio of etravirine Cmax when coadministered with boceprevir
793769|NCT01427504|O1|Outcome|Etravirine AUC Coadministered With Boceprevir|Geometric mean ratio of etravirine AUC when coadministered with boceprevir
794961|NCT01422369|B1|Baseline|All Subjects|All randomized subjects
793773|NCT01427504|O1|Outcome|Etravirine Cmin|Geometric mean of etravirine Cmin when administered alone.
793774|NCT01427504|O1|Outcome|Etravirine Cmax|Geometric mean of etravirine Cmax when administered alone.
793775|NCT01427504|O1|Outcome|Etravirine AUC|Geometric mean of etravirine AUC when administered alone.
793776|NCT01427504|O1|Outcome|Boceprevir C8|Geometric mean of boceprevir Cmax when administered alone.
793777|NCT01427504|O1|Outcome|Boceprevir Cmax|Geometric mean of boceprevir Cmax when administered alone.
793778|NCT01427504|O1|Outcome|Boceprevir AUC|Geometric mean of boceprevir AUC administered alone.
793779|NCT01427504|E3|Reported Event|Boceprevir Coadministered With Etravirine|Boceprevir, 800 mg thrice daily, coadministered with etravirine, 200 mg twice daily for 10-14 days.
793780|NCT01427504|E2|Reported Event|Etravirine Alone|Subjects took etravirine alone, 200 mg twice daily, for 10-14 days
793781|NCT01427504|E1|Reported Event|Boceprevir Alone|Subjects took boceprevir alone, 800 mg thrice daily, for 10-14 days.
793782|NCT01427309|B5|Baseline|Total|Total of all reporting groups
793783|NCT01427309|B4|Baseline|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793784|NCT01427309|B3|Baseline|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793785|NCT01427309|B2|Baseline|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793786|NCT01427309|B1|Baseline|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793787|NCT01427309|P4|Participant Flow|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793788|NCT01427309|P3|Participant Flow|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793789|NCT01427309|P2|Participant Flow|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793790|NCT01427309|P1|Participant Flow|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793791|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793792|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793793|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793794|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793795|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793796|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793797|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793798|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793799|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793800|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793801|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793802|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793803|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793804|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793805|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793806|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793807|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793808|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793809|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793810|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793811|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793812|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793813|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793814|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793815|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793816|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793817|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793818|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793819|NCT01427309|O4|Outcome|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793820|NCT01427309|O3|Outcome|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793821|NCT01427309|O2|Outcome|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793822|NCT01427309|O1|Outcome|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793823|NCT01427309|E4|Reported Event|Fluzone® Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone vaccine
793824|NCT01427309|E3|Reported Event|Fluzone® High Dose Vaccine (Year 2)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793825|NCT01427309|E2|Reported Event|Fluzone® Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone vaccine
793826|NCT01427309|E1|Reported Event|Fluzone® High Dose Vaccine (Year 1)|Adults ≥65 years of age received one dose of Fluzone High Dose vaccine
793827|NCT01426958|B1|Baseline|Overall Study|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
793828|NCT01426958|P1|Participant Flow|All Participants|This is an open-label, randomized, three-way crossover clinical phase I trial in healthy volunteers.
793829|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
793830|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
793831|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
793832|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
793833|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
793834|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
793835|NCT01426958|O3|Outcome|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
793836|NCT01426958|O2|Outcome|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
793837|NCT01426958|O1|Outcome|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
793838|NCT01426958|E3|Reported Event|Afatinib + Timed Rtv|Subjects were treated with Rtv 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 six hours prior to third Rtv dose.
793839|NCT01426958|E2|Reported Event|Afatinib + Concomittant Rtv|Subjects were treated with Ritonavir (Rtv) 2x100mg twice daily (bid) on Days -1, 1 and 2 and with a single dose of Afatinib 40mg on Day 1 with third Rtv dose.
793840|NCT01426958|E1|Reported Event|Afatinib|Subjects were treated with a single dose of Afatinib 40mg on Day 1.
793841|NCT01426867|B4|Baseline|Total|Total of all reporting groups
793842|NCT01426867|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
793843|NCT01426867|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
793844|NCT01426867|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
793845|NCT01426867|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
793846|NCT01426867|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
793847|NCT01426867|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
793848|NCT01426867|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
793849|NCT01426867|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
793850|NCT01426867|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
793851|NCT01426867|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each affected eye 3 times a day for 7 days
793852|NCT01426867|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each affected eye 3 times a day for 7 days
793853|NCT01426867|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each affected eye 3 times a day for 7 days
793854|NCT01426854|B3|Baseline|Total|Total of all reporting groups
793855|NCT01426854|B2|Baseline|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793856|NCT01426854|B1|Baseline|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793857|NCT01426854|P2|Participant Flow|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793858|NCT01426854|P1|Participant Flow|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793859|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793860|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793861|NCT01426854|O2|Outcome|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
794126|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794076|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
793862|NCT01426854|O1|Outcome|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793863|NCT01426854|E2|Reported Event|Placebo|Nepafenac Vehicle, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793864|NCT01426854|E1|Reported Event|Nepafenac|Nepafenac Ophthalmic Suspension, 0.1%, 1 drop to the operative eye, 3 times a day, beginning 1 day preoperatively and continuing through the day of surgery and for 14 days postoperatively. An additional dose was administered prior to surgery.
793865|NCT01426789|B3|Baseline|Total|Total of all reporting groups
793866|NCT01426789|B2|Baseline|Placebo|Placebo i.v.
793867|NCT01426789|B1|Baseline|Secukinumab|10 mg/kg intravenous (I.V.)
793868|NCT01426789|P6|Participant Flow|Group 4|Part 1: placebo; Part 2: no study treatment
793869|NCT01426789|P5|Participant Flow|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
793870|NCT01426789|P4|Participant Flow|Group 2|Part 1: secukinumab 6 x 10 mg/kg i.v.; part 2: no study treatment
793871|NCT01426789|P3|Participant Flow|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
793872|NCT01426789|P2|Participant Flow|Placebo|Placebo i.v.
793873|NCT01426789|P1|Participant Flow|Secukinumab|10 mg/kg intravenous (I.V.)
793874|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
793875|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
793876|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
793877|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
793878|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
793879|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
793880|NCT01426789|O2|Outcome|Placebo|Placebo i.v.
793881|NCT01426789|O1|Outcome|Secukinumab|10 mg/kg intravenous (I.V.)
793882|NCT01426789|E4|Reported Event|Group 3|Part 1: placebo; Part 2: secukinumab 4 x 300 mg sc loading dose (at weeks 12, 13, 14 and 16), then 300 mg sc monthly
793883|NCT01426789|E3|Reported Event|Group 1|Part 1: secukinumab 6 x 10 mg/kg i.v.; Part 2: secukinumab 300 mg sc monthly
793884|NCT01426789|E2|Reported Event|Placebo|Placebo i.v.
793885|NCT01426789|E1|Reported Event|Secukinumab|10mg/kg i.v.
793886|NCT01426763|B3|Baseline|Total|Total of all reporting groups
793887|NCT01426763|B2|Baseline|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
793888|NCT01426763|B1|Baseline|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
793889|NCT01426763|P2|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
793890|NCT01426763|P1|Participant Flow|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous (SC) injection of 1000 Units of CINRYZE with 20,000 Units of recombinant human hyaluronidase (rHuPH20) twice weekly for two weeks
793891|NCT01426763|O2|Outcome|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
793892|NCT01426763|O1|Outcome|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
793893|NCT01426763|E2|Reported Event|SC CINRYZE With rHuPH20 Dose Level 2|Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two weeks
793894|NCT01426763|E1|Reported Event|SC CINRYZE With rHuPH20 Dose Level 1|Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
793895|NCT01426555|B3|Baseline|Total|Total of all reporting groups
793896|NCT01426555|B2|Baseline|Rowing Arm|Thirty five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
793897|NCT01426555|B1|Baseline|ZA Infusion Arm|Thirty five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were enrolled.
793898|NCT01426555|P2|Participant Flow|ZA Infusion Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~After the observation period, subjects in the FES rowing plus zoledronic acid arm were planned to receive Zoledronic Acid (Reclast ®) administered as a dose of 5mg intravenously.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
793899|NCT01426555|P1|Participant Flow|Rowing Arm|"Prior to FES-row, subjects undertook a 2 -12 weeks strength-training program at SRH, depending on how the subjects respond to the FES-strength training. Subjects who completed strength training, progressed to rowing.~In the FES-Rowing program, the goal was for each subject to achieve an exercise intensity of 75-85% maintained for a continuous 40 minutes performed 3 times each week in additional to maintaining strength training at home on days when they are not rowing.~All subjects received a daily minimum supplementation of 1000mg Calcium & 1000 IUs of Vitamin-D supplementation during the duration of the program."
793900|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
793901|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI, were enrolled.~Dataset unavailable for analysis to VABHS study team. The study was closed by the VABHS IRB."
793902|NCT01426555|O2|Outcome|Rowing Arm|"Thirty Five subjects, in each arm age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
794962|NCT01422369|P1|Participant Flow|All Subjects|All randomized subjects
793903|NCT01426555|O1|Outcome|ZA Infusion Arm|"Thirty Five subjects in each arm, age 18 years or older and wheelchair dependent at least 50% of the time because of an SCI were planned to be enrolled.~No Data was analyzed because dataset is not available to VABHS Study team."
793904|NCT01426555|E2|Reported Event|Rowing Arm|No adverse event data were available for the remaining 16 participants.
793905|NCT01426555|E1|Reported Event|ZA Infusion Arm|No adverse event data were available for the remaining 9 participants.
793906|NCT01426516|B3|Baseline|Total|Total of all reporting groups
793907|NCT01426516|B2|Baseline|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
793908|NCT01426516|B1|Baseline|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
793909|NCT01426516|P2|Participant Flow|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
793910|NCT01426516|P1|Participant Flow|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
793911|NCT01426516|O2|Outcome|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
793912|NCT01426516|O1|Outcome|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
793913|NCT01426516|E2|Reported Event|Genecept Assay|"Subjects donate DNA sample for genetic testing and treatment decisions take genetic results into account.~Genecept Assay: Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders"
793914|NCT01426516|E1|Reported Event|Treatment as Usual (TAU)|Subjects will give DNA sample for genetic testing but will not receive genetic results and will therefore receive treatment as usual.
793915|NCT01426438|B3|Baseline|Total|Total of all reporting groups
793916|NCT01426438|B2|Baseline|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793917|NCT01426438|B1|Baseline|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793918|NCT01426438|P2|Participant Flow|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793919|NCT01426438|P1|Participant Flow|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793920|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793921|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793922|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793923|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793924|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793925|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793926|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793927|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793928|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793929|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793930|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793931|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793932|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
794074|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
793933|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793934|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793935|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793936|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793937|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793938|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793939|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793940|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793941|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793942|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793943|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793944|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793945|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793946|NCT01426438|O2|Outcome|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793947|NCT01426438|O1|Outcome|Arm A: Extended-release Niacin With Aspirin|"Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)~Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24."
793948|NCT01426438|E2|Reported Event|Arm B: Fenofibrate|Fenofibrate: Fenofibrate administered as 200 mg by mouth once daily for 24 weeks.
793949|NCT01426438|E1|Reported Event|Arm A: Extended-release Niacin With Aspirin|Niacin: Extended-release niacin given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24) Aspirin: Aspirin 325 mg given by mouth in the evening with extended-release niacin through week 24.
793950|NCT01426425|B1|Baseline|mITT Set|The modified intent-to-treat (mITT) set.
793951|NCT01426425|P1|Participant Flow|All Participants|All subjects enrolled into the study.
793952|NCT01426425|O1|Outcome|mITT Subjects With Acute Procedural Success|The modified intent-to-treat (mITT) subjects who had acute procedural success with cryoablation for the treatment of AVNRT.
793953|NCT01426425|O1|Outcome|mITT Set|The modified intent-to-treat (mITT) set.
793954|NCT01426425|O1|Outcome|mITT Set|The modified intent-to-treat (mITT) set.
793955|NCT01426425|E1|Reported Event|mITT Set|Subjects in the modified intent-to-treat (mITT) set.
793956|NCT01426373|B1|Baseline|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793957|NCT01426373|P1|Participant Flow|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793958|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793959|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793960|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793961|NCT01426373|O2|Outcome|Month 12 After Last Treatment|
793962|NCT01426373|O1|Outcome|Month 3 After Last Treatment|
793963|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793964|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793965|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793966|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793967|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793968|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793969|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793970|NCT01426373|O1|Outcome|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793971|NCT01426373|E1|Reported Event|Deoxycholic Acid 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
793972|NCT01426360|B3|Baseline|Total|Total of all reporting groups
793973|NCT01426360|B2|Baseline|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
793974|NCT01426360|B1|Baseline|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
793975|NCT01426360|P2|Participant Flow|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
793976|NCT01426360|P1|Participant Flow|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
793977|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
793978|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
793979|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
793980|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
793981|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
793982|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
793983|NCT01426360|O2|Outcome|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
793984|NCT01426360|O1|Outcome|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
793985|NCT01426360|E2|Reported Event|Control Dentifrice|Subjects receive a commercially available control dentifrice containing exactly the same ingredients with the exception of strontium chloride and potassium nitrate (the control group)
793986|NCT01426360|E1|Reported Event|Strontium Chloride/Potassium Nitrate Dentifrice|Subjects receive a commercially available dentifrice containing 2% strontium chloride and 5% potassium nitrate in a silica base (the experimental group)
793987|NCT01426347|B3|Baseline|Total|Total of all reporting groups
793988|NCT01426347|B2|Baseline|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
793989|NCT01426347|B1|Baseline|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
793990|NCT01426347|P2|Participant Flow|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
793991|NCT01426347|P1|Participant Flow|Placebo Group|"Rheumatoid Arthritis (RA) patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
793992|NCT01426347|O2|Outcome|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
794075|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
793993|NCT01426347|O1|Outcome|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
793994|NCT01426347|O2|Outcome|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
793995|NCT01426347|O1|Outcome|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
793996|NCT01426347|E2|Reported Event|Ergocalciferol|"Patients with vitamin D deficiency will be randomized to either active or placebo group. In the active group, patients will receive ergocalciferol 50,000 IU per week for 16 weeks.~Ergocalciferol: Ergocalciferol 50,000 IU per week for 16 weeks"
793997|NCT01426347|E1|Reported Event|Placebo Group|"RA Patients with vitamin D deficiency will be randomized to placebo and active intervention arms.~Patients in the placebo arm will receive I placebo pill per week for 16 weeks. After completing this arm, they will cross-over to the active treatment arm.~Placebo sugar pill: Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule."
793998|NCT01426269|B1|Baseline|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
793999|NCT01426269|P3|Participant Flow|Placebo|"Subjects will receive placebo during phase 2 (week 12 – week 52)~Placebo: During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning"
794000|NCT01426269|P2|Participant Flow|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during phase 2 (week 12 - week 52)~Oral Doxycycline: During phase 2 week 12 - week 52: Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
794001|NCT01426269|P1|Participant Flow|Doxycycline and Metronidazole Regimen|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)~Oral Doxycycline and Topical Metronidazole: During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area.~After Period 1, subjects who meet criteria for phase 2 will be randomized to receive doxycycline or placebo during phase 2"
794002|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794003|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794004|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794005|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794006|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794007|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794008|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794009|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794010|NCT01426269|O4|Outcome|Week 12|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794011|NCT01426269|O3|Outcome|Week 8|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794012|NCT01426269|O2|Outcome|Week 4|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794013|NCT01426269|O1|Outcome|Baseline|Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) and MetroGel® 1% (topical metronidazole) during phase 1 (baseline to week 12)
794014|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
794015|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
794016|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
794017|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
794018|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
794019|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
794020|NCT01426269|O2|Outcome|Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: During period 2, placebo, oral, one capsule daily in the morning"
794021|NCT01426269|O1|Outcome|Oral Doxycycline|"Subjects will receive Oracea® (oral doxycycline 40 mg USP (30 mg immediate release and 10 mg delayed release beads)) during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: During period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
794022|NCT01426269|E3|Reported Event|Period 2: Placebo|"Subjects will receive placebo during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Placebo: period 2, placebo, oral, one capsule daily in the morning"
794023|NCT01426269|E2|Reported Event|Period 2: Oral Doxycycline|"Subjects will receive oral doxycycline during period 2 (40 weeks) after 12 weeks of treatment with oral docycycline and topical metronidazole.~Oral Doxycycline: period 2, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning"
794024|NCT01426269|E1|Reported Event|Period 1: Oral Doxycycline and Topical Metronidazole|"Subjects will receive oral doxycycline and topical metronidazole during period 1 (12 weeks)~Oral Doxycycline and Topical Metronidazole: period 1, Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning and MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area"
794025|NCT01426230|B3|Baseline|Total|Total of all reporting groups
794026|NCT01426230|B2|Baseline|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
794027|NCT01426230|B1|Baseline|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
794028|NCT01426230|P2|Participant Flow|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
794029|NCT01426230|P1|Participant Flow|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
794030|NCT01426230|O2|Outcome|Open Label - Cohort <=70 Yrs Old|"Cohort by age-~- Patients <=70 Yrs old"
794031|NCT01426230|O1|Outcome|Open Label - Cohort >70 Yrs Old|"Cohort by age-~- Patients >70 Yrs old"
794032|NCT01426230|E1|Reported Event|Open Label - Both Cohorts|
794033|NCT01426113|B3|Baseline|Total|Total of all reporting groups
794034|NCT01426113|B2|Baseline|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
794035|NCT01426113|B1|Baseline|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
794036|NCT01426113|P2|Participant Flow|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
794037|NCT01426113|P1|Participant Flow|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
794038|NCT01426113|O2|Outcome|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
794039|NCT01426113|O1|Outcome|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
794040|NCT01426113|E2|Reported Event|Timolol Ophthalmic Solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
794041|NCT01426113|E1|Reported Event|Bimatoprost Ophthalmic Solution Formulation A and Vehicle|1 drop bimatoprost vehicle in the affected eye(s) in the morning and 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning and 1 drop bimatoprost vehicle in the affected eye(s) in the evening for 6 additional weeks.
794042|NCT01425879|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
794043|NCT01425879|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
794044|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
794045|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
794046|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
794047|NCT01425879|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
794048|NCT01425879|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Diagnostic Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
794049|NCT01425853|B3|Baseline|Total|Total of all reporting groups
794050|NCT01425853|B2|Baseline|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794051|NCT01425853|B1|Baseline|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794052|NCT01425853|P2|Participant Flow|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794053|NCT01425853|P1|Participant Flow|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794054|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794055|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794056|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794057|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794058|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794059|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794060|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794061|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794062|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794063|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794064|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794065|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794066|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794067|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794068|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794069|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794070|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794071|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794072|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794073|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794963|NCT01422369|O1|Outcome|All Subjects|All randomized subjects
794077|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794078|NCT01425853|O2|Outcome|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794079|NCT01425853|O1|Outcome|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794080|NCT01425853|E2|Reported Event|Celecoxib|"Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.~Celecoxib"
794081|NCT01425853|E1|Reported Event|Chondroitin Sulfate/ Glucosamine Hydrochloride (Droglican)|"Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.~Pharmacotherapeutic group: Other specific antirheumatic agents. ATC code: M01CX.~Chondroitin sulfate/ Glucosamine hydrochloride"
794082|NCT01425814|B1|Baseline|Overall Population|All patients who were randomized and received at least one dose of investigational medicinal product
794083|NCT01425814|P6|Participant Flow|Sequence F|Placebo - Indacaterol 150 μg - LAS100977 5 μg - LAS100977 10 μg - LAS100977 2.5 μg - LAS100977 0.625 μg
794084|NCT01425814|P5|Participant Flow|Sequence E|LAS100977 5 μg - Placebo - LAS100977 2.5 μg - Indacaterol 150 μg - LAS100977 0.625 μg - LAS100977 10 μg
794085|NCT01425814|P4|Participant Flow|Sequence D|LAS100977 2.5 μg - LAS100977 5 μg - LAS100977 0.625 μg - Placebo - LAS100977 10 μg - Indacaterol 150 μg
794086|NCT01425814|P3|Participant Flow|Sequence C|LAS100977 0.625 μg - LAS100977 2.5 μg - LAS100977 10 μg - LAS100977 5 μg - Indacaterol 150 μg - Placebo
794087|NCT01425814|P2|Participant Flow|Sequence B|LAS100977 10 μg - LAS100977 0.625 μg - Indacaterol 150 μg - LAS100977 2.5 μg - Placebo - LAS100977 5 μg
794088|NCT01425814|P1|Participant Flow|Sequence A|Indacaterol 150 μg - LAS100977 10 μg - Placebo - LAS100977 0.625 μg - LAS100977 5 μg- LAS100977 2.5 μg
794089|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794090|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794091|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794092|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794093|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794094|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794095|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794096|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794097|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794098|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794099|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794100|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794101|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794102|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794103|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794104|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794105|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794106|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794107|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794108|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794109|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794110|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794111|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794112|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794113|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794114|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794115|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794116|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794117|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794118|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794119|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794120|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794121|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794122|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794123|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794124|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794127|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794128|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794129|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794130|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794131|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794132|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794133|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794134|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794135|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794136|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794137|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794138|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794139|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794140|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794141|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794142|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794143|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794144|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794145|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794146|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794147|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794148|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794149|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794150|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794151|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794152|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794153|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794154|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794155|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794156|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794157|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794158|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794159|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794160|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794161|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794162|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794163|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794164|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794165|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794166|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794167|NCT01425814|O6|Outcome|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794168|NCT01425814|O5|Outcome|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794169|NCT01425814|O4|Outcome|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794170|NCT01425814|O3|Outcome|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794171|NCT01425814|O2|Outcome|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794172|NCT01425814|O1|Outcome|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794173|NCT01425814|E6|Reported Event|Indacaterol 150 μg|Single dose administered by inhalation from the Breezhaler® inhaler
794174|NCT01425814|E5|Reported Event|LAS100977 10 μg|Single dose administered by inhalation from the Genuair® device
794175|NCT01425814|E4|Reported Event|LAS100977 5 μg|Single dose administered by inhalation from the Genuair® device
794176|NCT01425814|E3|Reported Event|LAS100977 2.5 μg|Single dose administered by inhalation from the Genuair® device
794177|NCT01425814|E2|Reported Event|LAS100977 0.625 μg|Single dose administered by inhalation from the Genuair® device
794178|NCT01425814|E1|Reported Event|Placebo|Single dose administered by inhalation from the Genuair® device and the Breezhaler® inhaler
794179|NCT01425749|B3|Baseline|Total|Total of all reporting groups
794180|NCT01425749|B2|Baseline|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794370|NCT01424813|E2|Reported Event|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794181|NCT01425749|B1|Baseline|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794182|NCT01425749|P2|Participant Flow|Arm B: Intradermal/Subcutaneous Injections|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794183|NCT01425749|P1|Participant Flow|Arm A: Intramuscular Injections|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794184|NCT01425749|O1|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794185|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794186|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794187|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794188|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794189|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794190|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794191|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794192|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794193|NCT01425749|O2|Outcome|Arm B|"Intradermal/Subcutaneous injections. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794194|NCT01425749|O1|Outcome|Arm A|"Intramuscular injections.~recMAGE-A3 + AS15 ASCI: Injections will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794195|NCT01425749|E2|Reported Event|Arm B|"Intradermal/Subcutaneous injections of recMAGE-A3 + AS15 ASCI. Requires an injection site biopsy at Day 8 and Day 50.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794196|NCT01425749|E1|Reported Event|Arm A|"Intramuscular injections of recMAGE-A3 + AS15 ASCI.~recMAGE-A3 + AS15 ASCI: Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit."
794197|NCT01425632|B4|Baseline|Total|Total of all reporting groups
794198|NCT01425632|B3|Baseline|Placebo|TAU-284 placebo twice daily for 2 weeks
794199|NCT01425632|B2|Baseline|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
794200|NCT01425632|B1|Baseline|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
794201|NCT01425632|P3|Participant Flow|Placebo|TAU-284 placebo twice daily for 2 weeks
794202|NCT01425632|P2|Participant Flow|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
794203|NCT01425632|P1|Participant Flow|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
794204|NCT01425632|O3|Outcome|Placebo|TAU-284 placebo twice daily for 2 weeks
794205|NCT01425632|O2|Outcome|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
794206|NCT01425632|O1|Outcome|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
794207|NCT01425632|E3|Reported Event|Placebo|TAU-284 placebo twice daily for 2 weeks
794208|NCT01425632|E2|Reported Event|TAU-284 High|TAU-284 10mg twice daily for 2 weeks
794209|NCT01425632|E1|Reported Event|TAU-284 Low|TAU-284 5mg twice daily for 2 weeks
794210|NCT01425528|B3|Baseline|Total|Total of all reporting groups
794964|NCT01422369|O1|Outcome|NK-104|NK-104 4mg once daily (QD)
794211|NCT01425528|B2|Baseline|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
794212|NCT01425528|B1|Baseline|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
794213|NCT01425528|P2|Participant Flow|Cohort 2|Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.
794214|NCT01425528|P1|Participant Flow|Cohort 1|This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.
794215|NCT01425528|O2|Outcome|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
794216|NCT01425528|O1|Outcome|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
794217|NCT01425528|E2|Reported Event|Cohort 2|"Participants in cohort 2 will be enrolled after the analysis of cohort 1 data has taken place. Dosing for cohort 2 will be based on results obtained in cohort 1.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
794218|NCT01425528|E1|Reported Event|Cohort 1|"This cohort will be enrolled first. Analysis will be done to determine the optimum dosing of Kuvan to normalize BH4 levels in the Cerebral Spinal Fluid.~Sapropterin: Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1."
794219|NCT01425463|B3|Baseline|Total|Total of all reporting groups
794220|NCT01425463|B2|Baseline|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794221|NCT01425463|B1|Baseline|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794222|NCT01425463|P2|Participant Flow|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794223|NCT01425463|P1|Participant Flow|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794224|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794225|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794226|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794227|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794296|NCT01425203|E1|Reported Event|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
794228|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794229|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794230|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794231|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794232|NCT01425463|O2|Outcome|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794233|NCT01425463|O1|Outcome|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794234|NCT01425463|E2|Reported Event|Polyferose|"Polyferose treatment with 150 mg twice daily (b.i.d) for 12 weeks plus Placebo to Ferrous (II) Glycine Sulphate Complex.~Polyferose: Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Ferrous (II) Glycine Sulphate Complex: Administered orally with water."
794235|NCT01425463|E1|Reported Event|Ferrous (II) Glycine Sulphate Complex|"Ferrous (II) Glycine Sulphate Complex treatment with 567.7 mg three times a day (t.i.d.) for 12 weeks plus Placebo to Polyferose.~Ferrous (II) Glycine Sulphate Complex: Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).~Administered orally with water.~Placebo to Polyferose: Administered orally with water."
794236|NCT01425359|B3|Baseline|Total|Total of all reporting groups
794237|NCT01425359|B2|Baseline|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794238|NCT01425359|B1|Baseline|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794239|NCT01425359|P2|Participant Flow|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794240|NCT01425359|P1|Participant Flow|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794241|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794242|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794297|NCT01425190|B4|Baseline|Total|Total of all reporting groups
794243|NCT01425359|O2|Outcome|Qualifying Phase: Participants Entered a 2-week Washout Period|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794244|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794245|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794246|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794247|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794248|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794249|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794250|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794251|NCT01425359|O2|Outcome|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794252|NCT01425359|O1|Outcome|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794253|NCT01425359|E2|Reported Event|Ranolazine|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment period: Ranolazine tablets (Day 1: 1 × 500 tablet in the evening; Days 2-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 8 weeks."
794294|NCT01425203|E3|Reported Event|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
794295|NCT01425203|E2|Reported Event|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
794254|NCT01425359|E1|Reported Event|Placebo|"Qualifying phase: Participants entered a 2-week washout period if needed to discontinue antianginal drugs (except beta-blockers) followed by placebo to match ranolazine (1 tablet twice daily) during a 4-week run-in period. Participants with at least 85% adherence to documentation requirements (angina frequency and sublingual nitroglycerin use) over the last 21 days of the placebo run-in period were randomized to the treatment period.~Treatment Period: Placebo to match ranolazine (Day 1: 1 tablet in the evening; Days 2-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 8 weeks."
794255|NCT01425307|B3|Baseline|Total|Total of all reporting groups
794256|NCT01425307|B2|Baseline|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
794257|NCT01425307|B1|Baseline|Standard Therapy|Standard Therapy of monthly transfusions
794258|NCT01425307|P2|Participant Flow|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
794259|NCT01425307|P1|Participant Flow|Standard Therapy|Standard Therapy of monthly transfusions
794260|NCT01425307|O2|Outcome|Treatment Arm|Hydroxyurea will be provided as capsules and liquid
794261|NCT01425307|O1|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
794262|NCT01425307|O2|Outcome|Treatment Arm|Hydroxyurea will be provided as capsules and liquid
794263|NCT01425307|O1|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
794264|NCT01425307|O2|Outcome|Standard Therapy|Standard Therapy of monthly transfusions
794265|NCT01425307|O1|Outcome|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
794266|NCT01425307|E2|Reported Event|Treatment Arm|"Hydroxyurea will be provided as capsules or liquid~Hydroxyurea: Capsules (300 mg, 400 mg, or 500 mg) taken once daily or liquid formulation (100 mg/mL)"
794267|NCT01425307|E1|Reported Event|Standard Therapy|Standard Therapy of monthly transfusions
794268|NCT01425229|B1|Baseline|Bosentan|Bosentan PK
794269|NCT01425229|P1|Participant Flow|Bosentan|Bosentan pharmacokinetics
794270|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
794271|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
794272|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
794273|NCT01425229|O3|Outcome|Bosentan During Clarithromycin|administration of bosentan 125 mg p.o. b.i.d. on day 11-14 and administration of clarithromycin 500 mg p.o b.i.d. on day 11-14
794274|NCT01425229|O2|Outcome|Bosentan at Steady-state|administration of bosentan 125 mg p.o. b.i.d. on day 2-10
794275|NCT01425229|O1|Outcome|Bosentan After First Dose|administration of bosentan 125 mg p.o. single dose
794276|NCT01425229|E3|Reported Event|Bosentan During Clarithromycin|Bosentan PK during clarithromycin
794277|NCT01425229|E2|Reported Event|Bosentan at Steady-state|Bosentan PK at steady-state
794278|NCT01425229|E1|Reported Event|Bosentan After First Dose|Bosentan PK after first dose
794279|NCT01425203|B3|Baseline|Total|Total of all reporting groups
794280|NCT01425203|B2|Baseline|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
794281|NCT01425203|B1|Baseline|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
794282|NCT01425203|P3|Participant Flow|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
794283|NCT01425203|P2|Participant Flow|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
794284|NCT01425203|P1|Participant Flow|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
794285|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
794286|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
794287|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
794288|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
794289|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
794290|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
794291|NCT01425203|O3|Outcome|Crossover Arm|Participants randomized to the PBO + PR Control arm who failed the futility rule at treatment week (TW) 12 or 24 were rolled over to the Crossover arm and received BOC + PR for 32 weeks and PR for up to 44 weeks depending on HCV-RNA level assessment at Crossover Weeks 4 and 8.
794292|NCT01425203|O2|Outcome|PBO + PR (Control)|Participants received PR for 4 weeks before addition of BOC-matched PBO. Participants then received BOC + PR for up to 44 weeks.
794293|NCT01425203|O1|Outcome|RGT BOC + PR|Participants received PR for 4 weeks before addition of BOC. Participants then received response guided therapy (RGT) with BOC + PR for up to 32 weeks followed by PBO + PR for up to 20 weeks.
794298|NCT01425190|B3|Baseline|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794299|NCT01425190|B2|Baseline|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794300|NCT01425190|B1|Baseline|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794301|NCT01425190|P3|Participant Flow|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794302|NCT01425190|P2|Participant Flow|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794303|NCT01425190|P1|Participant Flow|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794304|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794305|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794306|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794307|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794308|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794309|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794310|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794311|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794312|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794313|NCT01425190|O3|Outcome|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794369|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794965|NCT01422369|E1|Reported Event|All Subjects|All randomized subjects
794314|NCT01425190|O2|Outcome|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794315|NCT01425190|O1|Outcome|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794316|NCT01425190|E3|Reported Event|Cohort 3: Children <7 to ≥3 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 2. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794317|NCT01425190|E2|Reported Event|Cohort 2: Children <13 to ≥7 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such as pudding or applesauce. The first 4 participants were treated with boceprevir at a dose contingent on the PK and safety results in Cohort 1. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794318|NCT01425190|E1|Reported Event|Cohort 1: Children 17 to ≥13 Years|Participants were administered a single dose of boceprevir powder mixed in a suitable vehicle such pudding or applesauce. The first 4 participants were treated with a 11.4 mg/kg dose of boceprevir powder. The dose/weight ratio may be adjusted for the next 12 participants based on the evaluation of the PK, safety, and tolerability data from the first 4 participants.
794319|NCT01424943|B3|Baseline|Total|Total of all reporting groups
794320|NCT01424943|B2|Baseline|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794321|NCT01424943|B1|Baseline|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794322|NCT01424943|P2|Participant Flow|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794323|NCT01424943|P1|Participant Flow|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794324|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794325|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794326|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794327|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794328|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794329|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794330|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794331|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794332|NCT01424943|O2|Outcome|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794333|NCT01424943|O1|Outcome|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794334|NCT01424943|E2|Reported Event|IDEA Part C Services As Usual|IDEA Part C services as usual based on IFSP
794335|NCT01424943|E1|Reported Event|Stepping Stones Triple P Plus IDEA Part C Services as Usual|"10-15 sessions of Level 4 Standard Stepping Stones Triple P delivered in family homes~Stepping Stones Triple P: 10-12 session manualized intervention delivered in client homes. Families also recieved IDEA Part C early intervention services as usual per the family IFSP."
794336|NCT01424930|B3|Baseline|Total|Total of all reporting groups
794337|NCT01424930|B2|Baseline|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
794338|NCT01424930|B1|Baseline|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
794339|NCT01424930|P2|Participant Flow|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
794966|NCT01422356|B1|Baseline|12 Month Cohort|
794340|NCT01424930|P1|Participant Flow|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
794341|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
794342|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
794343|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
794344|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
794345|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
794346|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
794347|NCT01424930|O2|Outcome|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
794348|NCT01424930|O1|Outcome|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
794349|NCT01424930|E2|Reported Event|Abiraterone+Prednisone (High-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14
794350|NCT01424930|E1|Reported Event|Abiraterone+Prednisone (Low-fat Meal)|Participants received abiraterone acetate at a starting dose of 1,000 milligram (mg) once daily for 7 days post 30-minutes of a standardized low-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14. Prednisone was administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
794351|NCT01424813|B3|Baseline|Total|Total of all reporting groups
794352|NCT01424813|B2|Baseline|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794353|NCT01424813|B1|Baseline|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794354|NCT01424813|P2|Participant Flow|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794355|NCT01424813|P1|Participant Flow|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794356|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794357|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794358|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794359|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794360|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794361|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794362|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794363|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794364|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794365|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794366|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794367|NCT01424813|O1|Outcome|Placebo MDPI|Placebo multi-dose dry powder inhaler (MDPI) administered as 2 inhalations four times a day for 12 weeks.
794368|NCT01424813|O2|Outcome|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794967|NCT01422356|P1|Participant Flow|12 Month Cohort|16-20 year old males
794371|NCT01424813|E1|Reported Event|Albuterol MDPI|Albuterol multi-dose dry powder inhaler (MDPI) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for 12 weeks.
794372|NCT01424644|B3|Baseline|Total|Total of all reporting groups
794373|NCT01424644|B2|Baseline|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794374|NCT01424644|B1|Baseline|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794375|NCT01424644|P2|Participant Flow|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794376|NCT01424644|P1|Participant Flow|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794377|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794378|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794379|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794380|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794381|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794382|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794383|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794384|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794385|NCT01424644|O2|Outcome|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794386|NCT01424644|O1|Outcome|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794387|NCT01424644|E2|Reported Event|Placebo+Tdap+HPV|Subjects received one dose of Tdap, placebo, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794388|NCT01424644|E1|Reported Event|MenACWY-CRM+Tdap+HPV|Subjects received one dose of Tdap, MenACWY-CRM, and HPV concomitantly on day 1. A second and third dose of HPV was administered at 2 and 6 months, respectively, after the first dose.
794389|NCT01424501|B7|Baseline|Total|Total of all reporting groups
794390|NCT01424501|B6|Baseline|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794391|NCT01424501|B5|Baseline|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794392|NCT01424501|B4|Baseline|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794393|NCT01424501|B3|Baseline|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794394|NCT01424501|B2|Baseline|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794395|NCT01424501|B1|Baseline|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794396|NCT01424501|P6|Participant Flow|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794397|NCT01424501|P5|Participant Flow|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794398|NCT01424501|P4|Participant Flow|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794399|NCT01424501|P3|Participant Flow|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794400|NCT01424501|P2|Participant Flow|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794401|NCT01424501|P1|Participant Flow|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794402|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794403|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794404|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794405|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794406|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794407|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794408|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794409|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794410|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794411|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794412|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794413|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794414|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794415|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794416|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794417|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794418|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794419|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794420|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794421|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794422|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794423|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794424|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794425|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794426|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794427|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794428|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794429|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794430|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794431|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794608|NCT01424189|P2|Participant Flow|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
794432|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794433|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794434|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794435|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794436|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794437|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794438|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794439|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794440|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794441|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794442|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794443|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794444|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794445|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794446|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794447|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794448|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794449|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794450|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794451|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794452|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794453|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794454|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794455|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794456|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794457|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794458|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794459|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794460|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794461|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794796|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794462|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794463|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794464|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794465|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794466|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794467|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794468|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794469|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794470|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794471|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794472|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794473|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794474|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794475|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794476|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794477|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794478|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794479|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794480|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794481|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794482|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794483|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794484|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794485|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794486|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794487|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794488|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794489|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794490|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794491|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794797|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794492|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794493|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794494|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794495|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794496|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794497|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794498|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794499|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794500|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794501|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794502|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794503|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794504|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794505|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794506|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794507|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794508|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794509|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794510|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794511|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794512|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794513|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794514|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794515|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794516|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794517|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794518|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794519|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794520|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794521|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794798|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794522|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794523|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794524|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794525|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794526|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794527|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794528|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794529|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794530|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794531|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794532|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794533|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794534|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794535|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794536|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794537|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794538|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794539|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794540|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794541|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794542|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794543|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794544|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794545|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1
794546|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794547|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794548|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794549|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794550|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794551|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794799|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794552|NCT01424501|O6|Outcome|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794553|NCT01424501|O5|Outcome|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794554|NCT01424501|O4|Outcome|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794555|NCT01424501|O3|Outcome|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794556|NCT01424501|O2|Outcome|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794557|NCT01424501|O1|Outcome|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794558|NCT01424501|E6|Reported Event|TB Naive Saline Group|Subjects unaffected by tuberculosis who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794559|NCT01424501|E5|Reported Event|TB Naive GSK 692342 Group|Subjects unaffected by tuberculosis who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794560|NCT01424501|E4|Reported Event|TB Treated Saline Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who in this study received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794561|NCT01424501|E3|Reported Event|TB Treated GSK 692342 Group|Subjects having successfully completed treatment for TB disease at least 1 year prior to the study, who during this study received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794562|NCT01424501|E2|Reported Event|TB Treatment Saline Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment who received a placebo (physiological saline) according to a 2-dose schedule at Months 0 and 1.
794563|NCT01424501|E1|Reported Event|TB Treatment GSK 692342 Group|Subjects having completed the intensive phase of treatment, i.e. 2 to 4 months post initiation of treatment, who received the GSK 692342 vaccine according to a 2-dose schedule at Months 0 and 1.
794564|NCT01424228|B3|Baseline|Total|Total of all reporting groups
794565|NCT01424228|B2|Baseline|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794566|NCT01424228|B1|Baseline|Placebo|Tablet once daily before breakfast
794567|NCT01424228|P2|Participant Flow|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794568|NCT01424228|P1|Participant Flow|Placebo|Tablet once daily before breakfast
794569|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794570|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794571|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794572|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794573|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794574|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794575|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794576|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794577|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794578|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794579|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794580|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794581|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794582|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794583|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794584|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794585|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794586|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794587|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794588|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794589|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794590|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794591|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794592|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794593|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794594|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794595|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794596|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794597|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794598|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794599|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794600|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794601|NCT01424228|O2|Outcome|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794602|NCT01424228|O1|Outcome|Placebo|Tablet once daily before breakfast
794603|NCT01424228|E2|Reported Event|Prucalopride|1 mg or 2 mg tablet once daily before breakfast
794604|NCT01424228|E1|Reported Event|Placebo|Tablet once daily before breakfast
794605|NCT01424189|B3|Baseline|Total|Total of all reporting groups
794606|NCT01424189|B2|Baseline|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3, bilateral implantation
794607|NCT01424189|B1|Baseline|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
794609|NCT01424189|P1|Participant Flow|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
794610|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
794611|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
794612|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
794613|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
794614|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
794615|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
794616|NCT01424189|O2|Outcome|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
794617|NCT01424189|O1|Outcome|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
794618|NCT01424189|E2|Reported Event|ReSTOR IOL|AcrySof® ReSTOR® Multifocal IOL Model SA60D3
794619|NCT01424189|E1|Reported Event|ReSTOR Toric IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
794620|NCT01424072|B4|Baseline|Total|Total of all reporting groups
794621|NCT01424072|B3|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
794622|NCT01424072|B2|Baseline|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
794623|NCT01424072|B1|Baseline|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
794624|NCT01424072|P3|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
794625|NCT01424072|P2|Participant Flow|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
794626|NCT01424072|P1|Participant Flow|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
794627|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
794628|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
794629|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
794630|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
794631|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
794632|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
794633|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
794634|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
794635|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
794636|NCT01424072|O3|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
794637|NCT01424072|O2|Outcome|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
794666|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794667|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794638|NCT01424072|O1|Outcome|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
794639|NCT01424072|E3|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
794640|NCT01424072|E2|Reported Event|Auriculotherapy by Seeds|"The investigators used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.~auriculotherapy by seeds : We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day."
794641|NCT01424072|E1|Reported Event|Auriculotherapy by Needles|"The investigators used 3 points, Shenmen, Kidney, and Brain Stem with semi-permanent needles of 1.8 mm, 1 time per week for 8 sessions.~auriculotherapy by needles : The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion."
794642|NCT01424033|B1|Baseline|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
794643|NCT01424033|P1|Participant Flow|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
794644|NCT01424033|O1|Outcome|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
794645|NCT01424033|E1|Reported Event|N-Acetylcysteine|"This is an open label trial, all patient will be entered into one treatment arm.~N-Acetylcysteine: 600mg by mouth, three times daily for 12 months"
794646|NCT01423916|B4|Baseline|Total|Total of all reporting groups
794647|NCT01423916|B3|Baseline|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
794648|NCT01423916|B2|Baseline|Brexpiprzole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794649|NCT01423916|B1|Baseline|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794650|NCT01423916|P3|Participant Flow|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
794651|NCT01423916|P2|Participant Flow|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794652|NCT01423916|P1|Participant Flow|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD (once daily) on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794653|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794654|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794655|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794656|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants were randomised to 1 of 4 arms in a ratio of 2:2:1:1. On Day 1, all participants received brexpiprazole placebo tablets. Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794657|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794658|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794659|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794660|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794661|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794662|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794663|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794664|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794665|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794800|NCT01423084|O2|Outcome|MenB Lot 2|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794668|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794669|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794670|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794671|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794672|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794673|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794674|NCT01423916|O3|Outcome|Moxifloaxcin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794675|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794676|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794677|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794678|NCT01423916|O3|Outcome|Moxifloxacin 400mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794679|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794680|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794681|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who had received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794682|NCT01423916|O3|Outcome|Moxifloxacin 400 mg|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794683|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794684|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794685|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
794686|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794687|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794688|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
794689|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794690|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794691|NCT01423916|O3|Outcome|Moxifloxacin/ Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
794692|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794693|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794694|NCT01423916|O4|Outcome|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794695|NCT01423916|O3|Outcome|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794696|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794697|NCT01423916|O1|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794698|NCT01423916|O3|Outcome|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794699|NCT01423916|O2|Outcome|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794700|NCT01423916|O1|Outcome|Moxifloxacin/Placebo|Moxifloxacin/Placebo arm comprised of 2 groups: one who had received 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 1 and brexpiprazole placebo (as 4 tablets) QD on Days 2 to 12 and the other group who received brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and 400 mg moxifloxacin (as 1 tablet) plus brexpiprazole placebo (as 3 tablets) on Day 12.
794701|NCT01423916|E4|Reported Event|Placebo|Placebo arm comprised of all participants who received brexpiprazole placebo (as 3 tablets) on Day 1 and as 4 tablets QD on Days 2 to 12; and brexpiprazole placebo (as 4 tablets) QD on Days 1 to 11 and as 3 tablets on Day 12.
794702|NCT01423916|E3|Reported Event|Moxifloxacin|Moxifloxacin arm comprised of all participants who had received 400 mg moxifloxacin (as 1 tablet) on Day 1 and Day 12.
794703|NCT01423916|E2|Reported Event|Brexpiprazole 12mg|Participants received 12mg brexpiprazole (as two 5-mg tablets and two 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794704|NCT01423916|E1|Reported Event|Brexpiprazole 4mg|Participants received 4mg brexpiprazole (as four 1-mg tablets) QD on Days 1 to 11 and brexpiprazole placebo (as 4 tablets) QD on Day 12.
794705|NCT01423773|B1|Baseline|Overall|Each product worn bilaterally for two consecutive days in either Period One or Period Two. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
794706|NCT01423773|P2|Participant Flow|Lotrafilcon A Control, Then Lotrafilcon A Test|Lotrafilcon A control contact lenses worn in Period One, with lotrafilcon A test contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
794707|NCT01423773|P1|Participant Flow|Lotrafilcon A Test, Then Lotrafilcon A Control|Lotrafilcon A test contact lenses worn in Period One, with lotrafilcon A control contact lenses worn in Period Two. Each product was worn bilaterally for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2. A wash-out of 24 hours minimum to 3 weeks maximum separated the two periods.
794708|NCT01423773|O2|Outcome|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
794709|NCT01423773|O1|Outcome|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
794710|NCT01423773|E2|Reported Event|Lotrafilcon A Control|Lotrafilcon A control contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
794711|NCT01423773|E1|Reported Event|Lotrafilcon A Test|Lotrafilcon A test contact lenses worn for two consecutive days as follows: 20 minutes on Day 1, and 10 hours on Day 2.
794712|NCT01423760|B3|Baseline|Total|Total of all reporting groups
794713|NCT01423760|B2|Baseline|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
794714|NCT01423760|B1|Baseline|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
794715|NCT01423760|P2|Participant Flow|Multiple Myeloma|"Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.~Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide."
794716|NCT01423760|P1|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals. Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide, were only observed for PD (if applicable) and survival in 6-month intervals and were not provided treatment with tecemotide.
794717|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
794755|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794801|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794802|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794718|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
794719|NCT01423760|O2|Outcome|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
794720|NCT01423760|O1|Outcome|Non-small Cell Lung Cancer (NSCLC)|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
794721|NCT01423760|E2|Reported Event|Multiple Myeloma|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
794722|NCT01423760|E1|Reported Event|NSCLC|Subjects who received tecemotide in a feeder study continued treatment with tecemotide and had safety assessments performed until the discontinuation criteria described in the respective feeder study protocol were met. Once the subject discontinued maintenance treatment, an End of Treatment visit was performed. Thereafter, the subjects were observed for progression of disease (PD) (if applicable according to the respective feeder study protocol) and survival in 6-month intervals.
794723|NCT01423617|B3|Baseline|Total|Total of all reporting groups
794724|NCT01423617|B2|Baseline|Placebo|Placebo: 3 tablets 2 times daily
794725|NCT01423617|B1|Baseline|Zenoctil|Zenoctil: 3 tablets 2 times daily
794726|NCT01423617|P2|Participant Flow|Placebo|Placebo: 3 tablets 2 times daily
794727|NCT01423617|P1|Participant Flow|Zenoctil|Zenoctil: 3 tablets 2 times daily
794728|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
794729|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
794730|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
794731|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
794732|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
794733|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
794734|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
794735|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
794736|NCT01423617|O2|Outcome|Placebo|Placebo: 3 tablets 2 times daily
794737|NCT01423617|O1|Outcome|Zenoctil|Zenoctil: 3 tablets 2 times daily
794738|NCT01423617|E2|Reported Event|Placebo|Placebo: 3 tablets 2 times daily
794739|NCT01423617|E1|Reported Event|Zenoctil|Zenoctil: 3 tablets 2 times daily
794740|NCT01423604|B4|Baseline|Total|Total of all reporting groups
794741|NCT01423604|B3|Baseline|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794742|NCT01423604|B2|Baseline|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794743|NCT01423604|B1|Baseline|Ruxolitinib - Safety Run-In|Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]) + ruxolitinib at 15 mg BID.
794744|NCT01423604|P2|Participant Flow|Placebo|Part 2: Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794745|NCT01423604|P1|Participant Flow|Ruxolitinib|"Part 1: Subjects received capecitabine 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) + ruxolitinib 15 mg BID.~Part 2: Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID])."
794746|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794747|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794748|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794749|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794750|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794751|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794752|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794753|NCT01423604|O1|Outcome|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794754|NCT01423604|O2|Outcome|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794756|NCT01423604|E3|Reported Event|Placebo|Matching placebo tablets were administered as oral doses in the same manner as active drug during the randomized portion of the study. Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794757|NCT01423604|E2|Reported Event|Ruxolitinib|Subjects received ruxolitinib 15 mg BID plus capecitabine at a starting dose of 2000 mg/m^2 (1000 mg/m^2 twice a day [BID]).
794758|NCT01423604|E1|Reported Event|Ruxolitinib (Safety Run-In)|Subjects received capecitabine 2000 mg/m^2 daily (taken as 1000 mg/m2 twice daily [BID]) + ruxolitinib 15 mg BID
794759|NCT01423253|B1|Baseline|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794760|NCT01423253|P1|Participant Flow|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794761|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794762|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794763|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794764|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794765|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794766|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794767|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794768|NCT01423253|O1|Outcome|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794769|NCT01423253|E1|Reported Event|Lurasidone 20, 40, 60 mg|"Lurasidone 20, 40, or 60 mg/day flexibly dosed~Lurasidone: Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed"
794770|NCT01423162|B3|Baseline|Total|Total of all reporting groups
794771|NCT01423162|B2|Baseline|Drink Without Vit C Then Drink With Vit C|Dietary Intervention (without Vitamin C): Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
794772|NCT01423162|B1|Baseline|Drink With Vit C Then Drink Without Vit C|Dietary Intervention (with Vitamin C): Fortified oat drink with vitamin C followed by fortified oat drink without Vit C
794773|NCT01423162|P2|Participant Flow|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
794774|NCT01423162|P1|Participant Flow|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
794775|NCT01423162|O2|Outcome|Fortified Oat Drink Without Vitamin C|
794776|NCT01423162|O1|Outcome|Fortified Oat Drink With Vitamin C|
794777|NCT01423162|E2|Reported Event|Drink Without Vitamin C Then Drink With Vit C|Dietary Intervention: Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C.
794778|NCT01423162|E1|Reported Event|Drink With Vit C Then Drink Without Vit C|Dietary Intervention: Fortified oat drink with vitamin C followed by fortified oat drink without viatamin C
794779|NCT01423084|B3|Baseline|Total|Total of all reporting groups
794780|NCT01423084|B2|Baseline|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794781|NCT01423084|B1|Baseline|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794782|NCT01423084|P2|Participant Flow|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794783|NCT01423084|P1|Participant Flow|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794784|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794785|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794786|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794787|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794788|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794789|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794790|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794791|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794792|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794793|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794794|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794795|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794803|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794804|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794805|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794806|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794807|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794808|NCT01423084|O2|Outcome|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794809|NCT01423084|O1|Outcome|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794810|NCT01423084|E2|Reported Event|4CMenB_Siena|Subjects received two doses of rMenB+OMV NZ vaccine from lot 2 manufactured at Siena facility.
794811|NCT01423084|E1|Reported Event|4CMenB_Rosia|Subjects received two doses of rMenB+OMV NZ vaccine from lot 1 manufactured at Rosia facility.
794812|NCT01422915|B1|Baseline|Colestipol Therapy of Protoporphyria|4 subjects were assigned, all between 18-65 years of age.
794813|NCT01422915|P1|Participant Flow|Colestipol Treatment|Colestipol 2 grams twice daily for 5-6 months. Completion of sun sensitivity questionnaire and blood protoporphyrin concentrations. were obtained monthly.
794814|NCT01422915|O1|Outcome|Colestipol Treatment|Sun sensitivity and protoporphyrin levels
794815|NCT01422915|O1|Outcome|Colestipol Treatment|"gram morning and bedtime for 90 days; then~grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concns. were determined monthly."
794816|NCT01422915|E1|Reported Event|1st Period - Colestipol Optimal Dosage|"gram morning and bedtime for 90 days; then~grams morning and bedtime for 90 days. Sun sensitivity questionnaires and blood protoporphyrin concentrations were determined monthly."
794817|NCT01422889|B1|Baseline|ION Registry|The ION Registry population contains 1120 enrolled subjects with 1111 eligible for analysis. Subjects eligible for analysis includes subjects with at least one study stent implanted.
794818|NCT01422889|P1|Participant Flow|ION Registry|The ION Registry population consists of 1111 subjects that were enrolled and received a study stent.
794819|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
794820|NCT01422889|O1|Outcome|ION Registry|The ION Registry includes the 1111 enrolled subjects that received a study stent.
794821|NCT01422889|E1|Reported Event|ION Registry|The ION Registry population will contain the first 1115 consecutive, consenting patients
794822|NCT01422876|B11|Baseline|Total|Total of all reporting groups
794823|NCT01422876|B10|Baseline|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794824|NCT01422876|B9|Baseline|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794825|NCT01422876|B8|Baseline|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794826|NCT01422876|B7|Baseline|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794827|NCT01422876|B6|Baseline|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794828|NCT01422876|B5|Baseline|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794829|NCT01422876|B4|Baseline|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794830|NCT01422876|B3|Baseline|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794831|NCT01422876|B2|Baseline|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794852|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
795071|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
794832|NCT01422876|B1|Baseline|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation and treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794833|NCT01422876|P10|Participant Flow|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794834|NCT01422876|P9|Participant Flow|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794835|NCT01422876|P8|Participant Flow|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794836|NCT01422876|P7|Participant Flow|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794837|NCT01422876|P6|Participant Flow|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794838|NCT01422876|P5|Participant Flow|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794839|NCT01422876|P4|Participant Flow|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794840|NCT01422876|P3|Participant Flow|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794841|NCT01422876|P2|Participant Flow|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794842|NCT01422876|P1|Participant Flow|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation. Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin: Oral
794843|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794844|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794845|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794846|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794847|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794848|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794849|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794850|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794851|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794905|NCT01422720|O1|Outcome|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
794968|NCT01422356|O1|Outcome|Baseline Prevalence|
794853|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794854|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794855|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794856|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794857|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794858|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794859|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794860|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794861|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794862|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794863|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794864|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794865|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794866|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794867|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794868|NCT01422876|O5|Outcome|Treatment Naive: Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794869|NCT01422876|O4|Outcome|Treatment Naive: Empagliflozin 10 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794870|NCT01422876|O3|Outcome|Treatment Naive: Empagliflozin 25 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794871|NCT01422876|O2|Outcome|Treament Naive: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794872|NCT01422876|O1|Outcome|Treatment Naive: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population treatment naive defined as an absence of any oral antidiabetic therapy, GLP-1 analog or insulin for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794873|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794874|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Ora"
794875|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794876|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794877|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794878|NCT01422876|O5|Outcome|Metformin Background: Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral"
794879|NCT01422876|O4|Outcome|Metformin Background: Empagliflozin 10 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral"
794880|NCT01422876|O3|Outcome|Metformin Background: Empagliflozin 25 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral"
794881|NCT01422876|O2|Outcome|Metformin Background: Empagliflozin 10 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral"
794882|NCT01422876|O1|Outcome|Metformin Background: Empagliflozin 25 mg/Linagliptin 5 mg|"Study population on a stable background of metformin defined as pre-treated with metformin (≥1500 mg/day or on the maximum tolerated dose or the maximum dose according to local label) unchanged for 12 weeks prior to randomisation.~Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral"
794883|NCT01422876|E5|Reported Event|Linagliptin 5 mg|Reference therapy 2: Linagliptin tablets dose: 5 mg q.d. mode of admin.: Oral
794884|NCT01422876|E4|Reported Event|Empagliflozin 10 mg|Reference therapy 1: Empagliflozin tablets dose: 10 mg q.d. mode of admin.: Oral
794885|NCT01422876|E3|Reported Event|Empagliflozin 25 mg|Reference therapy 1: Empagliflozin tablets dose: 25 mg q.d. mode of admin.: Oral
794886|NCT01422876|E2|Reported Event|Empagliflozin 10 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 10 mg/5 mg q.d. mode of admin.: Oral
794887|NCT01422876|E1|Reported Event|Empagliflozin 25 mg/Linagliptin 5 mg|Test product: Empagliflozin/linagliptin FDC tablets dose: 25 mg/5 mg q.d. mode of admin.: Oral
794888|NCT01422850|B1|Baseline|ALECSAT|
794889|NCT01422850|P1|Participant Flow|ALECSAT|After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.
794890|NCT01422850|O1|Outcome|ALECSAT|
794891|NCT01422850|O1|Outcome|Trends Towards Possible Treatment Response|No significant conclusion of efficacy is possible due to the study design with only one active group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy are possible. Scintigraphy and blood tests (PSA, ALP, LDH and Creatinine)were used for this analysis.
794892|NCT01422850|O1|Outcome|ALCESAT|
794893|NCT01422850|E1|Reported Event|ALECSAT|
794894|NCT01422824|B1|Baseline|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
794895|NCT01422824|P1|Participant Flow|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current summaries of product characteristics (SPCs)/local labeling.
794896|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
794897|NCT01422824|O1|Outcome|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
794898|NCT01422824|E1|Reported Event|Mircera|Participants received Mircera® (methoxy polyethylene glycol-epoetin beta) according to the standard practice in line with current SPCs/local labeling.
794899|NCT01422720|B1|Baseline|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
794900|NCT01422720|P1|Participant Flow|Esl 800 mg|Eslicarbazepine Acetate (Esl) tablets (800 mg) QD
794901|NCT01422720|O4|Outcome|PPS- Treatment Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
794902|NCT01422720|O3|Outcome|PPS - Baseline Period|The Per Protocol Set (PPS) consisted of all subjects in the FAS who had completed the Treatment Period and did not have any protocol deviation (e.g. poor compliance, diaries not properly filled) in a sufficiently serious manner to warrant data (but not subject) exclusion.
794903|NCT01422720|O2|Outcome|FAS - Treatment Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
794904|NCT01422720|O1|Outcome|FAS - Baseline Period|The Full Analysis Set (FAS) consisted of all subjects who received at least one dose of IMP and had at least one day of seizure evaluation reported in the patient diary after Visit 2.
794908|NCT01422538|B3|Baseline|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment. Study subjects in Group C received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
794909|NCT01422538|B2|Baseline|Group B|Subjects received Sculptra® treatment only
794910|NCT01422538|B1|Baseline|Group A|Subjects received Ultherapy® Treatment only. Study subjects in Group A received approximately 400 lines of Ultherapy treatment (5.0PLUS Guideline followed).
794911|NCT01422538|P3|Participant Flow|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
794912|NCT01422538|P2|Participant Flow|Group B|Subjects received Sculptra® treatment only
794913|NCT01422538|P1|Participant Flow|Group A|Subjects received Ultherapy® Treatment only.
794914|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
794915|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
794916|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
794917|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
794918|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
794919|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
794920|NCT01422538|O2|Outcome|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
794921|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
794922|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
794923|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
794924|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
794925|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
794926|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
794927|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
794928|NCT01422538|O3|Outcome|Group C|Subjects received Sculptra® treatment and Ultherapy® treatment
794929|NCT01422538|O2|Outcome|Group B|Subjects received Sculptra® treatment only
794930|NCT01422538|O1|Outcome|Group A|Subjects received Ultherapy® Treatment only.
794931|NCT01422538|E3|Reported Event|Group C|Subjects received Sculptra® and Ultherapy® Treatment.
794932|NCT01422538|E2|Reported Event|Group B|Subjects received Sculptra® only.
794933|NCT01422538|E1|Reported Event|Group A|Subjects received Ultherapy® Treatment only.
794934|NCT01422434|B4|Baseline|Total|Total of all reporting groups
794935|NCT01422434|B3|Baseline|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
794936|NCT01422434|B2|Baseline|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
794937|NCT01422434|B1|Baseline|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
794938|NCT01422434|P3|Participant Flow|Rinderon® - DP Ointment (Betamethasone Dipropionate)|"Applied once daily for 4 weeks~Rinderon® - DP ointment ( betamethasone dipropionate) : Applied once daily for 4 weeks."
794939|NCT01422434|P2|Participant Flow|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
794940|NCT01422434|P1|Participant Flow|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
794941|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
794942|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
794943|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
794944|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
794945|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
794946|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
794947|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
794948|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
794949|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
794950|NCT01422434|O3|Outcome|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
794951|NCT01422434|O2|Outcome|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
794952|NCT01422434|O1|Outcome|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
794953|NCT01422434|E3|Reported Event|Rinderon® - DP Ointment|"Applied once daily for 4 weeks~Rinderon® - DP = betamethasone dipropionate : Applied once daily for 4 weeks."
794954|NCT01422434|E2|Reported Event|LEO 90105 Ointment|"LEO 90105 ointment applied once daily for 4 weeks.~LEO 90105 = calcipotriol + betamethasone dipropionate : Applied once daily for 4 weeks."
794955|NCT01422434|E1|Reported Event|Dovonex® Ointment|"Applied twice daily for 4 weeks.~Dovonex® = calcipotriol : Applied twice daily for 4 weeks."
794956|NCT01422382|B1|Baseline|All Subjects|All randomized subjects.
794957|NCT01422382|P1|Participant Flow|All Subjects|All randomized subjects.
794958|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
794959|NCT01422382|O1|Outcome|All Subjects|All randomized subjects.
794960|NCT01422382|E1|Reported Event|All Subjects|All randomized subjects.
794971|NCT01422304|B2|Baseline|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794972|NCT01422304|B1|Baseline|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794973|NCT01422304|P2|Participant Flow|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794974|NCT01422304|P1|Participant Flow|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794975|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794976|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794977|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794978|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794979|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794980|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794981|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794982|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794983|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
795067|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795068|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795069|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795070|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
794984|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794985|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794986|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794987|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794988|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794989|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794990|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794991|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794992|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794993|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794994|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794995|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794996|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
795011|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
794997|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
794998|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
794999|NCT01422304|O2|Outcome|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
795000|NCT01422304|O1|Outcome|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
795001|NCT01422304|E2|Reported Event|Usual Care|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single IV administration of neostigmine (up to a maximum dose of 5 mg) with glycopyrrolate or atropine and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of sugammadex that would have been administered).
795002|NCT01422304|E1|Reported Event|Sugammadex|For participants in this Arm assigned to planned active reversal of neuromuscular blockade: single intravenous (IV) administration of sugammadex 4 mg/kg and single IV administration of placebo (normal saline [NaCl 0.9%] to match volume of neostigmine/glycopyrrolate [or neostigmine/atropine] that would have been administered). For participants in this Arm assigned to planned spontaneous recovery from neuromuscular blockade: single IV administration of sugammadex 4 mg/kg.
795003|NCT01422239|B3|Baseline|Total|Total of all reporting groups
795004|NCT01422239|B2|Baseline|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
795005|NCT01422239|B1|Baseline|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
795006|NCT01422239|P2|Participant Flow|Standard Behavioral Counseling|The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's smoking cessation manual. All of the material for sessions 4-8 for the standard behavioral counseling condition will cover topics from the Mayo Clinic's smoking cessation manual - Session 4: coping with triggers to smoke and nicotine withdrawal, Session 5: Stress Management, Session 6: Time Management and Self-Image, Session 7: Communication Skills and Wellness, Session 8: Focusing on the Future (maintenance of smoking abstinence).
795007|NCT01422239|P1|Participant Flow|Tailored Behavioral Counseling|The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session, coping with withdrawal symptoms in the third session, and on coping with triggers and withdrawal in the forth session using the Mayo Clinic's smoking cessation manual. The focus of sessions 5-7 will be the three perceive risks of quitting that were not covered during the first three session (i.e., the three least highly endorsed risks). Session 8 will cover maintenance of smoking abstinence using the Mayo Clinic manual.
795008|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
795009|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
795010|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
795065|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795012|NCT01422239|O2|Outcome|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
795013|NCT01422239|O1|Outcome|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
795014|NCT01422239|E2|Reported Event|Standard Behavioral Counseling|"The focus of the first three sessions for participants receiving the standard treatment will be the benefits of quitting smoking. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. All participants will receive identical counseling sessions during week 4-8 based on material from the Mayo Clinic manual."
795015|NCT01422239|E1|Reported Event|Tailored Behavioral Counseling|"The focus of the first three sessions for participants receiving the tailored treatment will be their three most highly endorsed perceived risks of quitting. All participants will receive information about preparing for quit day in the second session and coping with withdrawal symptoms in the third session using the Mayo Clinic's Smoke Free and Living It manual. The last 5 counseling sessions will be based on perceived risks of quitting."
795016|NCT01422226|B3|Baseline|Total|Total of all reporting groups
795017|NCT01422226|B2|Baseline|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
795018|NCT01422226|B1|Baseline|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
795019|NCT01422226|P2|Participant Flow|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
795020|NCT01422226|P1|Participant Flow|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
795021|NCT01422226|O2|Outcome|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
795022|NCT01422226|O1|Outcome|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
795023|NCT01422226|E2|Reported Event|Placebo Comparator|Placebo: Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
795024|NCT01422226|E1|Reported Event|Experimental Active Comparator|Misoprostol: Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
795025|NCT01422213|B4|Baseline|Total|Total of all reporting groups
795026|NCT01422213|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795027|NCT01422213|B2|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795028|NCT01422213|B1|Baseline|Placebo|capsules, daily, orally
795029|NCT01422213|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets; daily; orally
795030|NCT01422213|P2|Participant Flow|Vortioxetine 10 mg|encapsulated tablets; daily; orally
795031|NCT01422213|P1|Participant Flow|Placebo|capsules; daily; orally
795032|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795033|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795034|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795035|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795036|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795037|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795038|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795039|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795040|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795041|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795042|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795043|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795044|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795045|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795046|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795047|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795048|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795049|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795050|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795051|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795052|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795053|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795054|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795055|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795056|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795057|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795058|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795059|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795060|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795061|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795062|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795063|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795064|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795073|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795074|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795075|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795076|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795077|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795078|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795079|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795080|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795081|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795082|NCT01422213|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
795083|NCT01422213|O2|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
795084|NCT01422213|O1|Outcome|Placebo|capsules, daily, orally
795085|NCT01422213|E3|Reported Event|Vortioxetine 20 mg|
795086|NCT01422213|E2|Reported Event|Vortioxetine 10 mg|
795087|NCT01422213|E1|Reported Event|Placebo|
795088|NCT01422187|B4|Baseline|Total|Total of all reporting groups
795089|NCT01422187|B3|Baseline|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795090|NCT01422187|B2|Baseline|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795091|NCT01422187|B1|Baseline|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795092|NCT01422187|P3|Participant Flow|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795093|NCT01422187|P2|Participant Flow|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795094|NCT01422187|P1|Participant Flow|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795095|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795096|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795097|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795098|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795099|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795100|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795101|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795102|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795103|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795104|NCT01422187|O3|Outcome|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795105|NCT01422187|O2|Outcome|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795106|NCT01422187|O1|Outcome|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795107|NCT01422187|E3|Reported Event|Dose Adjusted|"Subjects randomized to 30 units/kg but with dose increased~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795108|NCT01422187|E2|Reported Event|Taliglucerase Alfa 60 Units/kg|"Subjects randomized to 60 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795109|NCT01422187|E1|Reported Event|Taliglucerase Alfa 30 Units/kg|"Subjects randomized to receive 30 units/kg~Taliglucerase alfa: Taliglucerase infusion every two weeks for 21 months"
795110|NCT01422070|B3|Baseline|Total|Total of all reporting groups
795111|NCT01422070|B2|Baseline|Units Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
795112|NCT01422070|B1|Baseline|Units With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
795113|NCT01422070|P2|Participant Flow|Units in Hospitals Without Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals without intermediate care unit
795114|NCT01422070|P1|Participant Flow|Units in Hospitals With Intermediate Care Unit|Adult patients consecutively admitted to Intensive Care Units in hospitals with intermediate care unit
795115|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
795116|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
795117|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
795118|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
795119|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
795229|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795120|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
795121|NCT01422070|O2|Outcome|Units in Hospitals Without Intermediate Care Unit|Patients admitted to intensive care unit without intermediate care unit in the hospital
795122|NCT01422070|O1|Outcome|Units in Hospitals With Intermediate Care Unit|Patients admitted to intensive care unit with intermediate care unit in the hospital
795123|NCT01422070|E1|Reported Event|Adverse Events Not Collected|Adverse events were not collected
795124|NCT01421719|B1|Baseline|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
795125|NCT01421719|P1|Participant Flow|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
795126|NCT01421719|O1|Outcome|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
795127|NCT01421719|O1|Outcome|Urinary Leaks Per Day|3-day voiding diary produced the clinical observation as an average per evaluation milestone.
795128|NCT01421719|E1|Reported Event|Botulinum Toxin Treatment|Injection of Botox into urinary bladder for neurogenic symptoms.
795129|NCT01421667|B5|Baseline|Total|Total of all reporting groups
795130|NCT01421667|B4|Baseline|CD30+ DLBCL, BV+R|
795131|NCT01421667|B3|Baseline|CD30u DLBCL, BV|
795132|NCT01421667|B2|Baseline|CD30+ B-Cell NHL, BV|
795133|NCT01421667|B1|Baseline|CD30+ T-Cell NHL, BV|
795134|NCT01421667|P4|Participant Flow|CD30+ DLBCL, BV+R|Part B - Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients with CD30-positive diffuse large B-cell lymphoma (DLBCL)
795135|NCT01421667|P3|Participant Flow|CD30u DLBCL, BV|Part C - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
795136|NCT01421667|P2|Participant Flow|CD30+ B-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients with CD30-positive B-cell non-Hodgkin lymphomas (NHL), including CD30-positive diffuse large B-cell lymphoma (DLBCL) and other CD30-positive B-cell NHLs
795137|NCT01421667|P1|Participant Flow|CD30+ T-Cell NHL, BV|Part A - Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive mature T-cell non-Hodgkin lymphomas (NHL)
795138|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
795139|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
795140|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795141|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
795142|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
795143|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795144|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
795145|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
795146|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795147|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
795148|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
795149|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795150|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
795151|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
795152|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795153|NCT01421667|O3|Outcome|CD30u DLBCL, BV|
795154|NCT01421667|O2|Outcome|CD30+ B-Cell NHL, BV|
795155|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795156|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
795157|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
795158|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
795159|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795160|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
795161|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
795162|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
795163|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795164|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
795165|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
795166|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
795167|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795168|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
795169|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
795170|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
795171|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795172|NCT01421667|O5|Outcome|CD30+ DLBCL, BV+R|
795173|NCT01421667|O4|Outcome|CD30u DLBCL, BV|
795174|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|
795175|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|
795176|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|
795177|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|
795178|NCT01421667|O1|Outcome|CD30+ DLBCL, BV+R|Part B - CD30-positive diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
795179|NCT01421667|O4|Outcome|CD30u DLBCL, BV|Part C - CD30u diffuse large B-cell lymphoma (DLBCL) includes only the pathological diagnosis of DLBCL.
795180|NCT01421667|O3|Outcome|CD30+ DLBCL, BV|Part A - CD30-positive diffuse large B-cell lymphoma (DLBCL) include pathological diagnoses of DLBCL, Epstein-Barr Virus (EBV)-associated DLBCL of the elderly, and T-cell rich B-cell lymphoma.
795181|NCT01421667|O2|Outcome|CD30+ Other B-Cell NHL, BV|Part A - CD30-positive other B-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of follicular lymphoma, gray zone lymphoma, primary mediastinal B-cell lymphoma (PMBL), post-transplant lymphoproliferative disease (PTLD), and plasmablastic lymphoma.
795182|NCT01421667|O1|Outcome|CD30+ T-Cell NHL, BV|Part A - CD30-positive T-cell non-Hodgkin lymphomas (NHL) include pathological diagnoses of angioimmunoblastic T-cell lymphoma (AITL) and peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS).
795183|NCT01421667|E3|Reported Event|CD30+ DLBCL, BV+R|Brentuximab vedotin (BV) 1.8 mg/kg plus rituximab (R; first 8 cycles only) (375 mg/m2) every 3 weeks by intravenous (IV) infusion in patients in Part B with diffuse large B-cell lymphoma (DLBCL)
795184|NCT01421667|E2|Reported Event|CD30u DLBCL, BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in Part C with diffuse large B-cell lymphoma (DLBCL) with undetectable CD30 (CD30u)
795230|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795185|NCT01421667|E1|Reported Event|CD30+ NHL (T-Cell and B-Cell), BV|Brentuximab vedotin (BV) 1.8 mg/kg every 3 weeks by intravenous (IV) infusion in patients in with CD30-positive non-Hodgkin lymphomas (NHL), including T-cell lymphomas and B-cell lymphomas, as well as diffuse large B-cell lymphoma (DLBCL)
795186|NCT01421654|B3|Baseline|Total|Total of all reporting groups
795187|NCT01421654|B2|Baseline|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
795188|NCT01421654|B1|Baseline|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
795189|NCT01421654|P2|Participant Flow|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
795190|NCT01421654|P1|Participant Flow|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
795191|NCT01421654|O2|Outcome|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
795192|NCT01421654|O1|Outcome|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
795193|NCT01421654|E2|Reported Event|Fixed Mode Only|S9 Elite Flow Generator with Fixed Mode only
795194|NCT01421654|E1|Reported Event|Fixed Mode + Acclimate|S9 Elite flow generator with Acclimate feature activated.
795195|NCT01421641|B3|Baseline|Total|Total of all reporting groups
795196|NCT01421641|B2|Baseline|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
795197|NCT01421641|B1|Baseline|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
795198|NCT01421641|P2|Participant Flow|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
795199|NCT01421641|P1|Participant Flow|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
795200|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
795201|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
795202|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
795203|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
795204|NCT01421641|O2|Outcome|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
795205|NCT01421641|O1|Outcome|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
795206|NCT01421641|E2|Reported Event|Topical Lidocaine Gel|Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
795207|NCT01421641|E1|Reported Event|Intracervical Lidocaine Injection|Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
795208|NCT01421589|B1|Baseline|Growth Hormone|Growth hormone treatment: Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795209|NCT01421589|P1|Participant Flow|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795210|NCT01421589|O1|Outcome|Growth Hormone|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795211|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795212|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795213|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795214|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795215|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795216|NCT01421589|O1|Outcome|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795217|NCT01421589|E1|Reported Event|Growth Hormone Treatment|Growth hormone treatment: recombinant human Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
795218|NCT01421511|B3|Baseline|Total|Total of all reporting groups
795219|NCT01421511|B2|Baseline|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795220|NCT01421511|B1|Baseline|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
795221|NCT01421511|P2|Participant Flow|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795222|NCT01421511|P1|Participant Flow|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795223|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795224|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795225|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795226|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795227|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795228|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795231|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795232|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795233|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795234|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795235|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795236|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795237|NCT01421511|O2|Outcome|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795238|NCT01421511|O1|Outcome|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo.
795239|NCT01421511|E2|Reported Event|Linezolid|IV to oral linezolid 600 mg twice daily for 10 days.
795240|NCT01421511|E1|Reported Event|Tedizolid Phosphate|IV to oral tedizolid phosphate 200 mg once daily for 6 days followed by 4 days of placebo.
795241|NCT01421498|B3|Baseline|Total|Total of all reporting groups
795242|NCT01421498|B2|Baseline|Placebo|
795243|NCT01421498|B1|Baseline|Lifitegrast 5.0%|
795244|NCT01421498|P2|Participant Flow|Placebo|
795245|NCT01421498|P1|Participant Flow|Lifitegrast 5.0%|
795246|NCT01421498|O2|Outcome|Placebo|
795247|NCT01421498|O1|Outcome|Lifitegrast 5.0%|
795248|NCT01421498|O2|Outcome|Placebo|
795249|NCT01421498|O1|Outcome|Lifitegrast 5.0%|
795250|NCT01421498|E2|Reported Event|Placebo|
795251|NCT01421498|E1|Reported Event|Lifitegrast 5.0%|
795252|NCT01421472|B5|Baseline|Total|Total of all reporting groups
795253|NCT01421472|B4|Baseline|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795254|NCT01421472|B3|Baseline|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795255|NCT01421472|B2|Baseline|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795256|NCT01421472|B1|Baseline|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795257|NCT01421472|P4|Participant Flow|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795258|NCT01421472|P3|Participant Flow|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795259|NCT01421472|P2|Participant Flow|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795260|NCT01421472|P1|Participant Flow|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795261|NCT01421472|O4|Outcome|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795262|NCT01421472|O3|Outcome|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795263|NCT01421472|O2|Outcome|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795264|NCT01421472|O1|Outcome|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795265|NCT01421472|E4|Reported Event|TN: Paclitaxel|"Triple negative (TN) patients randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795266|NCT01421472|E3|Reported Event|TN: MM-121 + Paclitaxel|"Triple Negative (TN) patients randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795267|NCT01421472|E2|Reported Event|HR+: Paclitaxel Only|"Hormone-receptor positive (HR+) sub-group randomized to receive:~Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery."
795387|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795268|NCT01421472|E1|Reported Event|HR+: MM-121+ Paclitaxel|"Hormone-receptor positive (HR+) sub-group randomized to receive:~2 week run-in of MM-121 (20 mg/kg weekly IV infusion over 60 minutes following a 40 mg/kg loading dose), followed by 4 cycles of MM-121 (20 mg/kg weekly) + Paclitaxel (80 mg/kg IV infusion weekly over 60 minutes) for 12 weeks, followed by 4 cycles of doxorubicin and cyclophosphamide (8 weeks)"
795269|NCT01421459|B3|Baseline|Total|Total of all reporting groups
795270|NCT01421459|B2|Baseline|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795271|NCT01421459|B1|Baseline|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795272|NCT01421459|P2|Participant Flow|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795273|NCT01421459|P1|Participant Flow|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795274|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795275|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795276|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795277|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795278|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795279|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795280|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795281|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795282|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795283|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795284|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795285|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795286|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795287|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795288|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795289|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795290|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795291|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795292|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795293|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795294|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795295|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795296|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795297|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795383|NCT01421134|B1|Baseline|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795298|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795299|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795300|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795301|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795302|NCT01421459|O2|Outcome|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795303|NCT01421459|O1|Outcome|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795304|NCT01421459|E2|Reported Event|Lantus + OAMs|Lantus titrated based on BG readings, administered subcutaneously, once daily in combination with at least 2 OAMs administered per standard of care for 24 weeks
795305|NCT01421459|E1|Reported Event|LY2963016 + OAMs|LY2963016 titrated based on blood glucose (BG) readings, administered subcutaneously, once daily in combination with at least 2 oral antihyperglycemic medications (OAMs) administered per standard of care for 24 weeks
795306|NCT01421355|B1|Baseline|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
795307|NCT01421355|P1|Participant Flow|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
795308|NCT01421355|O1|Outcome|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
795309|NCT01421355|E1|Reported Event|Atazanavir 300 mg BID|"Atazanavir 300 mg BID for 4 days.~Atazanavir: The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug."
795310|NCT01421303|B1|Baseline|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795311|NCT01421303|P1|Participant Flow|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795312|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795313|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795314|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795315|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795316|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795317|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795318|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795319|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795320|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795321|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795322|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795323|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795384|NCT01421134|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
795324|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795325|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795326|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795327|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795328|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795329|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795330|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795331|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795332|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795333|NCT01421303|O1|Outcome|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795334|NCT01421303|E1|Reported Event|Etanercept|Participants diagnosed with active Ankylosing Spondylitis (AS) and starting an anti-Tumor Necrosis Factor (anti-TNF) treatment with etanercept (Enbrel) 25 milligram (mg) twice weekly or 50 mg once weekly were observed prospectively for up to 2 years.
795335|NCT01421277|B3|Baseline|Total|Total of all reporting groups
795336|NCT01421277|B2|Baseline|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
795337|NCT01421277|B1|Baseline|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
795338|NCT01421277|P2|Participant Flow|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
795339|NCT01421277|P1|Participant Flow|Participants Enrolled in Protocol Version (V)1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
795340|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
795341|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
795342|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
795343|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
795344|NCT01421277|O2|Outcome|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
795345|NCT01421277|O1|Outcome|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
795346|NCT01421277|E2|Reported Event|Participants Enrolled in Protocol V2|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V2 of this study.
795347|NCT01421277|E1|Reported Event|Participants Enrolled in Protocol Version V1.1|Participants with physician-diagnosed migraine with or without aura who are treatment-naive to triptans, who received their first prescription for a triptan and took at least one dose within 6 months prior to being included in Protocol V1.1 of this study.
795348|NCT01421147|B3|Baseline|Total|Total of all reporting groups
795349|NCT01421147|B2|Baseline|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795350|NCT01421147|B1|Baseline|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795351|NCT01421147|P2|Participant Flow|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795352|NCT01421147|P1|Participant Flow|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795353|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795354|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795355|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795356|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795357|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795358|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795359|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795360|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795361|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795362|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795363|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795364|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795385|NCT01421134|P1|Participant Flow|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795386|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
795365|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795366|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795367|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795368|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795369|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795370|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795371|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795372|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795373|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795374|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795375|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795376|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795377|NCT01421147|O2|Outcome|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795378|NCT01421147|O1|Outcome|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795379|NCT01421147|E2|Reported Event|Lantus + Insulin Lispro|Lantus dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795380|NCT01421147|E1|Reported Event|LY2963016 + Insulin Lispro|LY2963016 dose was titrated based on blood glucose readings, and administered subcutaneously, once daily at the same timing (daytime or evening/bedtime) as participant's prestudy basal insulin injection schedule in combination with premeal insulin lispro for 52 weeks. Insulin lispro dosing was titrated based on blood glucose readings, and administered subcutaneously, 3 times a day for 52 weeks.
795381|NCT01421134|B3|Baseline|Total|Total of all reporting groups
795382|NCT01421134|B2|Baseline|Placebo|"Placebo~Placebo: Placebo"
796817|NCT01412281|E2|Reported Event|≥18 to ≤60 Years - CSL HA Antigen|
795389|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795390|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
795391|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795392|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
795393|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795394|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
795395|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795396|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
795397|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795398|NCT01421134|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
795399|NCT01421134|O1|Outcome|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795400|NCT01421134|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo"
795401|NCT01421134|E1|Reported Event|Lurasidone|"Lurasidone 20, 40 or 60 mg~Lurasidone: 20, 40, 60 mg, flexible dose, once daily PM 6 weeks"
795402|NCT01420926|B3|Baseline|Total|Total of all reporting groups
795403|NCT01420926|B2|Baseline|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795404|NCT01420926|B1|Baseline|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795405|NCT01420926|P2|Participant Flow|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795406|NCT01420926|P1|Participant Flow|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795407|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795408|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795409|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795504|NCT01419977|B2|Baseline|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
795410|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795411|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795412|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795413|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795414|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795415|NCT01420926|O2|Outcome|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795416|NCT01420926|O1|Outcome|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795417|NCT01420926|E2|Reported Event|Arm II (Decitabine and Bortezomib)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 2-11 and 1.3 mg/m^2 bortezomib SC on days 1, 4, 8, and 11. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 1.3 mg/m^2 bortezomib SC on day 1 and 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795418|NCT01420926|E1|Reported Event|Arm I (Decitabine)|"REMISSION INDUCTION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-10. Treatment repeats every 28 days for 2-4 courses in the absence of disease progression or unacceptable toxicity. Patients not achieving CR or CRi proceed to continuation therapy. Patients achieving CR or CRi proceed to maintenance therapy.~CONTINUATION THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive 20 mg/m^2 decitabine IV over 1 hour QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
795419|NCT01420848|B4|Baseline|Total|Total of all reporting groups
795420|NCT01420848|B3|Baseline|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
795421|NCT01420848|B2|Baseline|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
795422|NCT01420848|B1|Baseline|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
795423|NCT01420848|P3|Participant Flow|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
795424|NCT01420848|P2|Participant Flow|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
795425|NCT01420848|P1|Participant Flow|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
795426|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
795427|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
795428|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
795429|NCT01420848|O3|Outcome|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
795430|NCT01420848|O2|Outcome|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
795431|NCT01420848|O1|Outcome|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
795432|NCT01420848|E3|Reported Event|Placebo Group|Auriculotherapy by sham, at the fist and outer ear points. These points aren't indicated for stress and anxiety.
795433|NCT01420848|E2|Reported Event|Control Group|Control Group didn't receive any treatment and was evaluated at the same time and the same way of interventions group
795434|NCT01420848|E1|Reported Event|Auriculotherapy Group|"The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.~Two points were chosen to treat stress and anxiety (Shenmen and Brainstem).~Auriculotherapy : Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological."
795435|NCT01420289|B3|Baseline|Total|Total of all reporting groups
795436|NCT01420289|B2|Baseline|Excercise|Walking on a graded treadmill for 45 minutes once daily
795437|NCT01420289|B1|Baseline|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
795438|NCT01420289|P2|Participant Flow|Excercise|Walking on a graded treadmill for 45 minutes once daily
795439|NCT01420289|P1|Participant Flow|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
795440|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
795441|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
795442|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
795443|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
795444|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
795445|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
795446|NCT01420289|O2|Outcome|Excercise|Walking on a graded treadmill for 45 minutes once daily
795447|NCT01420289|O1|Outcome|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
795448|NCT01420289|E2|Reported Event|Excercise|Walking on a graded treadmill for 45 minutes once daily
795449|NCT01420289|E1|Reported Event|HPIPC|High Pressure Intermittent Pneumatic compression (HPIPC)to be performed for 1 hour twice daily
795450|NCT01420146|B1|Baseline|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
795451|NCT01420146|P1|Participant Flow|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
795452|NCT01420146|O1|Outcome|Zr89-trastuzumab PET/CT|Zr89-trastuzumab (trastuzumab labelled with zirconium 89) for PET/CT single arm
795453|NCT01420146|E1|Reported Event|Zr89-trastuzumab PET/CT|"Zr89-trastuzumab PET/CT single arm~Zr89-trastuzumab: trastuzumab labelled with zirconium 89 for PET/CT"
795454|NCT01420081|B10|Baseline|Total|Total of all reporting groups
795455|NCT01420081|B9|Baseline|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795456|NCT01420081|B8|Baseline|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795478|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795457|NCT01420081|B7|Baseline|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795458|NCT01420081|B6|Baseline|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795459|NCT01420081|B5|Baseline|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795460|NCT01420081|B4|Baseline|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795461|NCT01420081|B3|Baseline|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
795462|NCT01420081|B2|Baseline|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795463|NCT01420081|B1|Baseline|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
795464|NCT01420081|P9|Participant Flow|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795465|NCT01420081|P8|Participant Flow|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795466|NCT01420081|P7|Participant Flow|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795467|NCT01420081|P6|Participant Flow|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795468|NCT01420081|P5|Participant Flow|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, once weekly (Quaque, QW) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795469|NCT01420081|P4|Participant Flow|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795470|NCT01420081|P3|Participant Flow|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
795471|NCT01420081|P2|Participant Flow|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795472|NCT01420081|P1|Participant Flow|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, once daily (QD) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
795473|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795474|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795475|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795476|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795477|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795575|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
795479|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795480|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795481|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795482|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795483|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795484|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795485|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795486|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795487|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795488|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795489|NCT01420081|O2|Outcome|PF-04691502 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795490|NCT01420081|O1|Outcome|PF-04691502 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795491|NCT01420081|O3|Outcome|PF-05212384 (PI3K Basal + Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal + activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795492|NCT01420081|O2|Outcome|PF-05212384 (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795493|NCT01420081|O1|Outcome|PF-05212384 (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants were given PF-05212384 QW (Days 1, 8, 15 and 22 of each cycle), with a ±3 day window.
795494|NCT01420081|E9|Reported Event|LIC PF-05212384 (154 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 154 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795495|NCT01420081|E8|Reported Event|LIC PF-05212384 (89 mg)|Participants who were enrolled in the PF-05212384 LIC began dosing with PF-05212384 89 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05212384 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795496|NCT01420081|E7|Reported Event|Lead-in-cohort (LIC) PF-04691502 (4 mg)|Participants who were enrolled in the PF-04691502 LIC began dosing with PF-04691502 4 mg at least 4 days (but no more than 10 days) prior to Cycle 1 Day 1 and continued taking PF-05691502 until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795497|NCT01420081|E6|Reported Event|PF-05212384 154 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795498|NCT01420081|E5|Reported Event|PF-05212384 154 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants received PF-05212384 154 mg by 30 minute infusion at the study site, QW (Quaque [Once Weekly]) until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795499|NCT01420081|E4|Reported Event|PF-04691502 6 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795500|NCT01420081|E3|Reported Event|PF-04691502 8 mg (PI3K Activated)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K activated). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
795501|NCT01420081|E2|Reported Event|PF-04691502 6 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 6 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death.
795502|NCT01420081|E1|Reported Event|PF-04691502 8 mg (PI3K Basal)|Eligible participants were categorized by PI3K pathway activation status (i.e. PI3K basal). Participants self-administered PF-04691502 8 mg orally, QD until they experienced unacceptable toxicity, disease progression, significant deviation, withdrawal of consent or death. Dose of the participants were reduced to 6 mg if they were on 8 mg dose.
795503|NCT01419977|B3|Baseline|Total|Total of all reporting groups
795505|NCT01419977|B1|Baseline|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
795506|NCT01419977|P2|Participant Flow|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
795507|NCT01419977|P1|Participant Flow|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
795508|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
795509|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
795510|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
795511|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
795512|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
795513|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
795514|NCT01419977|O2|Outcome|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
795515|NCT01419977|O1|Outcome|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
795516|NCT01419977|E2|Reported Event|Dalteparin|Dalteparin: Low molecular weight heparin (LMWH), 5000 units subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
795517|NCT01419977|E1|Reported Event|Placebo|Placebo: Normal saline solution, administered by nursing staff once daily
795518|NCT01419795|B3|Baseline|Total|Total of all reporting groups
795519|NCT01419795|B2|Baseline|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795520|NCT01419795|B1|Baseline|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795521|NCT01419795|P2|Participant Flow|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795522|NCT01419795|P1|Participant Flow|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795523|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795524|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795525|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795526|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795527|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795576|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
795577|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
795578|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
795580|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
795528|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795529|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795530|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795531|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795532|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795533|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795534|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795535|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795536|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795537|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795538|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795539|NCT01419795|O2|Outcome|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795540|NCT01419795|O1|Outcome|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795541|NCT01419795|E2|Reported Event|Arm II (Lenalidomide)|"Patients who have relapsed/progressed at any time point post-transplant and who have contraindications, prior severe hypersensitivity reaction to rituximab infusion, to receive rituximab or have CD20 negative disease (Cohort 3) receive lenalidomide as in Arm I.~lenalidomide: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
796818|NCT01412281|E1|Reported Event|≥18 to ≤60 Years - AdImmune HA Antigen|
795542|NCT01419795|E1|Reported Event|Arm I (Lenalidomide, Rituximab)|"Patients who have relapsed/progressed within 180 days post-transplant (Cohort 1), beyond day 180 post-transplant (Cohort 2), or within 6 months but were not started within 3 months of relapse, receive lenalidomide PO QD on days 1-28 (patients with CLL/SLL/PLL) or days 1-21 (patients with NHL). Patients in Cohorts 1 and 2 also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and then every two months for courses 3, 5, 7, 9, and 11.~lenalidomide: Given PO~rituximab: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
795543|NCT01419769|B1|Baseline|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795544|NCT01419769|P1|Participant Flow|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795545|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795546|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795547|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795548|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795549|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795550|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795579|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
795551|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795552|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795553|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795554|NCT01419769|O1|Outcome|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795555|NCT01419769|E1|Reported Event|AXIOS Stent and Delivery System|"AXIOS Stent & Delivery System: The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
795556|NCT01419639|B1|Baseline|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
795557|NCT01419639|P1|Participant Flow|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
795558|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
795559|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
795560|NCT01419639|O1|Outcome|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
795561|NCT01419639|E1|Reported Event|RAD001|RAD001 taken orally continuously until disease progression or unacceptable toxicity, dosed according to age
795562|NCT01419314|B3|Baseline|Total|Total of all reporting groups
795563|NCT01419314|B2|Baseline|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
795564|NCT01419314|B1|Baseline|LE Splints Group|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
795565|NCT01419314|P2|Participant Flow|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
795566|NCT01419314|P1|Participant Flow|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
795567|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
795568|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
795569|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
795570|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
795571|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study.
795572|NCT01419314|O1|Outcome|Splinting Application|Participants will be asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
795573|NCT01419314|O2|Outcome|Splint Liner Application|The liner or protective sheath from the Walkabout™ splint was applied to the LEs, with the structural frame of the splint removed by the researcher in advance.
795574|NCT01419314|O1|Outcome|Splinting Application|Participants were asked to wear a pair of LE night splints for the duration of the study (6 weeks) at night/during sleep only.
795581|NCT01419314|O2|Outcome|Splint Liner|Night time application of lower extremity splint liner
795582|NCT01419314|O1|Outcome|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
795583|NCT01419314|E2|Reported Event|Splint Liner|Night time application of lower extremity splint liner
795584|NCT01419314|E1|Reported Event|Lower Extremity Splinting Application|nighttime splint application to the lower extremities
795585|NCT01419249|B3|Baseline|Total|Total of all reporting groups
795586|NCT01419249|B2|Baseline|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795587|NCT01419249|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795588|NCT01419249|P2|Participant Flow|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795589|NCT01419249|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795590|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795591|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795592|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795593|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795594|NCT01419249|O1|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795595|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795596|NCT01419249|O2|Outcome|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795597|NCT01419249|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795598|NCT01419249|E2|Reported Event|Turner Syndrome (TS) Cohort|Participants with pre-established diagnosis of TS and were treated with r-hGH therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795599|NCT01419249|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD) Cohort|Participants with pre-established diagnosis of IGHD and were treated with recombinant human growth hormone (r-hGH) therapy for at least 1 year were observed in this retrospective cohort study wherein blood sampling was performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
795600|NCT01419236|B3|Baseline|Total|Total of all reporting groups
795601|NCT01419236|B2|Baseline|Placebo|Placebo solution applied topically once daily for 16 weeks.
795602|NCT01419236|B1|Baseline|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795603|NCT01419236|P2|Participant Flow|Placebo|Placebo solution applied topically once daily for 16 weeks.
795604|NCT01419236|P1|Participant Flow|Testosterone Solution 2%|Testosterone solution 2% [60 milligrams (mg) applied topically once daily with a potential 1-time titration to 30 milligrams per day (mg/day) or 90 mg/day] for 16 weeks.
795605|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795692|NCT01418937|B1|Baseline|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
795606|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795607|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795608|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795609|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795610|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795611|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795612|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795613|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795614|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795615|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795616|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795617|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795618|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795619|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795620|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795621|NCT01419236|O2|Outcome|Placebo|Placebo solution applied topically once daily for 16 weeks.
795622|NCT01419236|O1|Outcome|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795623|NCT01419236|E2|Reported Event|Placebo|Placebo solution applied topically once daily for 16 weeks.
795624|NCT01419236|E1|Reported Event|Testosterone Solution 2%|Testosterone solution 2% [60 mg applied topically once daily with a potential 1-time titration to 30 mg/day or 90 mg/day] for 16 weeks.
795625|NCT01419197|B3|Baseline|Total|Total of all reporting groups
795626|NCT01419197|B2|Baseline|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795627|NCT01419197|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795628|NCT01419197|P2|Participant Flow|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and human epidermal growth factor receptor 2 (HER2)-directed therapy.
795629|NCT01419197|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795630|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795631|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795632|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795633|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795634|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795635|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795636|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795637|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795638|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795639|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795693|NCT01418937|P1|Participant Flow|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
795694|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
795695|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
795640|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795641|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795642|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795643|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795644|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795645|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795646|NCT01419197|O2|Outcome|Treatment of Physician’s Choice|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795647|NCT01419197|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795648|NCT01419197|E3|Reported Event|Trastuzumab Emtansine - Post TPC Treatment Switch|Participants, who switched treatment in the Treatment of Physician's Choice arm to trastuzumab emtansine, were administered trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795649|NCT01419197|E2|Reported Event|Treatment of Physician’s Choice (TPC)|Treatment of physician’s choice until disease progression (as assessed by the investigator) or unmanageable toxicity. The treatments included single-agent chemotherapy, single-agent or dual-agent hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
795650|NCT01419197|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg intravenously every 3 weeks until disease progression (as assessed by the investigator) or unmanageable toxicity.
795651|NCT01419184|B3|Baseline|Total|Total of all reporting groups
795652|NCT01419184|B2|Baseline|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795653|NCT01419184|B1|Baseline|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795654|NCT01419184|P2|Participant Flow|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed per investigator’s discretion and was administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occured first. Investigators treated participants according to their usual decision-making and discretion.
795655|NCT01419184|P1|Participant Flow|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for complicated skin and skin structure infections (cSSSI) or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795656|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795657|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795658|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795659|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795660|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795661|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795662|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795663|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795831|NCT01417455|P2|Participant Flow|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
795664|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795665|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795666|NCT01419184|O2|Outcome|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795667|NCT01419184|O1|Outcome|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795668|NCT01419184|E2|Reported Event|Vancomycin|Vancomycin was reconstituted per the manufacturer’s instructions and was dosed and administered intravenously until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795669|NCT01419184|E1|Reported Event|Daptomycin|Daptomycin 4 milligrams per kilogram (mg/kg) was administered intravenously once a day until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
795670|NCT01419171|B1|Baseline|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795671|NCT01419171|P1|Participant Flow|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795672|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795673|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795674|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795675|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795676|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795677|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795678|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795679|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795680|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795681|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795682|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795683|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795684|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795685|NCT01419171|O1|Outcome|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795686|NCT01419171|E1|Reported Event|OMEGA™ Monorail Coronary Stent System|OMEGA™ Monorail Coronary Stent System: All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
795687|NCT01419028|B1|Baseline|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
795688|NCT01419028|P1|Participant Flow|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
795689|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
795690|NCT01419028|O1|Outcome|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
795691|NCT01419028|E1|Reported Event|Retrospective Observational|Patients with severe perinatal and/or infantile onset HPP (ie, where signs of the disease are present before 6 months of age).
795696|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
795697|NCT01418937|O1|Outcome|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
795698|NCT01418937|E1|Reported Event|Cervarix Group|Subjects received 3 intramuscular injections of Cervarix™ vaccine according to a 0, 1, 6-month schedule.
795699|NCT01418703|B3|Baseline|Total|Total of all reporting groups
795700|NCT01418703|B2|Baseline|Enhanced Control to Range (eCTR)|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual’s conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
795701|NCT01418703|B1|Baseline|Standard Control to Range (sCTR)|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
795702|NCT01418703|P4|Participant Flow|eCTR Closed-Loop First, Then Open-Loop|"Participants completed open-loop admission, then completed eCTR closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR."
795703|NCT01418703|P3|Participant Flow|Open-Loop First, Then eCTR Closed-Loop|"Participants completed open-loop admission, then completed eCTR (Enhanced Control to Range) closed-loop admission.~The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC (model predictive control) algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the clinical research center (CRC) kitchen but automatically calculated by eCTR."
795704|NCT01418703|P2|Participant Flow|sCTR Closed-Loop First, Then Open-Loop|"Participants completed sCTR Closed-Loop admission, then completed open-loop admission.~The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour."
795705|NCT01418703|P1|Participant Flow|Open-Loop First, Then sCTR Closed-Loop|"Completed open-loop, then sCTR (Standard Control to Range ) Closed-Loop admission.~The two modules of sCTR are the SSM (safety supervision module) and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM (continuous glucose monitor) and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g. body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII (continuous subcutaneous insulin infusion) parameters."
795706|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
795832|NCT01417455|P1|Participant Flow|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
795788|NCT01417936|E1|Reported Event|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795707|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
795708|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
795709|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
795710|NCT01418703|O2|Outcome|Closed Loop|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed Loop Control (CLC): During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms."
795711|NCT01418703|O1|Outcome|Open Loop|"The subject were in charge of their insulin treatment.~Open Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
795712|NCT01418703|E3|Reported Event|eCTR Closed-Loop Control|The two modules of the eCTR are the SSM and an enhanced range control module based on an MPC algorithm that aims to maintain glycemia in a target range. eCTR also uses insulin-on-board constraints (29) intended to prevent insulin overdose during intensified therapy. The rationale behind MPC was presented in detail in a recent review (7). Controller aggressiveness was individualized for each subject based on readily available patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery) (30). In this application, the MPC worked using information from the individual's conventional therapy. Premeal boluses were triggered by the patient, with the carbohydrate amount measured in the CRC kitchen but automatically calculated by eCTR.
795713|NCT01418703|E2|Reported Event|sCTR Closed-Loop Control|The two modules of sCTR are the SSM and a standard range control module that avoids prolonged hyperglycemic excursions. Both modules use a real-time estimate of the patient 's metabolic state based on CGM and insulin infusion data. This estimate is used for prediction of the risks of hypo-and hyperglycemia 30-45 min ahead of the event. If a risk for hypoglycemia is predicted, the SSM attenuates automatically any insulin requests proportionally to the predicted risk level. How aggressively the system attenuates insulin is determined with patient characteristics (e.g., body weight, insulin-to-carbohydrate ratio, and basal insulin delivery). If a risk for hyperglycemia is predicted, the range controller gives a correction bolus using the predicted plasma glucose and the patient's CSII parameters; the system injects only half of the computed bolus and can do so once every hour.
795714|NCT01418703|E1|Reported Event|Open-Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
795715|NCT01418482|B1|Baseline|Mepilex Border Ag|Mepilex Border Ag, ( a silver dressing)
795716|NCT01418482|P1|Participant Flow|Mepilex Border Ag|Mepilex Border Ag, a silver dressing
795717|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
795718|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
795719|NCT01418482|O1|Outcome|Mepilex Border Ag|Mepilex Border Ag
795720|NCT01418482|E1|Reported Event|Mepilex Border Ag|Mepilex Border Ag
795721|NCT01418365|B3|Baseline|Total|Total of all reporting groups
795722|NCT01418365|B2|Baseline|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
795723|NCT01418365|B1|Baseline|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
795724|NCT01418365|P2|Participant Flow|Metronidazole + MMX Mesalazine/Mesalamine First|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, first; then Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally, second
795725|NCT01418365|P1|Participant Flow|Metronidazole + MMX Placebo First|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally,first; then Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally, second
795726|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
795727|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
795728|NCT01418365|O2|Outcome|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
795729|NCT01418365|O1|Outcome|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
795730|NCT01418365|E2|Reported Event|Metronidazole + MMX Mesalazine/Mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
795731|NCT01418365|E1|Reported Event|Metronidazole + MMX Placebo|Metronidazole 750 mg twice daily + MMX placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX placebo single dose on Day 4 orally
795732|NCT01418209|B4|Baseline|Total|Total of all reporting groups
795733|NCT01418209|B3|Baseline|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795734|NCT01418209|B2|Baseline|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795735|NCT01418209|B1|Baseline|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795736|NCT01418209|P3|Participant Flow|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795737|NCT01418209|P2|Participant Flow|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795738|NCT01418209|P1|Participant Flow|Low-dose 17-ß-Estradiol With Progesterone Taper|Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably. The 8 week estradiol treatment is followed 14 days (2 weeks) of progesterone taper (as medroxy-progesterone 10 mg/day).
795739|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795740|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795741|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795742|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795743|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795786|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795744|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795745|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795746|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795747|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795748|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795749|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795750|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795751|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795752|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795753|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795754|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795755|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795756|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795757|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795758|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795787|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795833|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
795789|NCT01417481|B3|Baseline|Total|Total of all reporting groups
795759|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795760|NCT01418209|O3|Outcome|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795761|NCT01418209|O2|Outcome|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795762|NCT01418209|O1|Outcome|Low-dose 17-ß-estradiol With Progesterone Taper|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795763|NCT01418209|E3|Reported Event|Placebo|Placebo: The placebo is an inactive pill that looks like the active medication.
795764|NCT01418209|E2|Reported Event|Venlafaxine XR|Venlafaxine XR: Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
795765|NCT01418209|E1|Reported Event|Low-dose 17-ß-estradiol|Low-dose 17-ß-estradiol: Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. After the 8-week treatment, women with a uterus will receive medroxyprogesterone 10 mg once per day for 2 weeks (14 days). 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably.
795766|NCT01418001|B1|Baseline|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
795767|NCT01418001|P1|Participant Flow|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
795768|NCT01418001|O1|Outcome|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
795769|NCT01418001|E1|Reported Event|Level 1: Pazopanib 400 mg QD|Level 1: Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination with Pazopanib
795770|NCT01417936|B1|Baseline|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795771|NCT01417936|P1|Participant Flow|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795772|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795773|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795774|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795775|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795776|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795777|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795778|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795779|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795780|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795781|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795782|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795783|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795784|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795785|NCT01417936|O1|Outcome|Sym004|Sym004 was administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
795790|NCT01417481|B2|Baseline|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
795791|NCT01417481|B1|Baseline|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
795792|NCT01417481|P2|Participant Flow|Placebo, Then Glycine|"First intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses)."
795793|NCT01417481|P1|Participant Flow|Glycine, Then Placebo|"First intervention (8 weeks) with Glycine (0.5 g/kg/day divided in three doses).~Washout period of 2 weeks. Second intervention (8 weeks) with Placebo (sugar glass, 0.5 g/kg/day divided in three doses)."
795794|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795795|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795796|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795797|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795798|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795799|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795800|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795801|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795802|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795803|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795804|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795805|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795806|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795807|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795808|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795809|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795810|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795811|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795812|NCT01417481|O2|Outcome|Placebo|All study participants receiving a daily oral supplement of 0.5 g/kg placebo (sugar glass) dissolved in water during 8 weeks.
795813|NCT01417481|O1|Outcome|Glycine|All study participants receiving a daily oral supplement of 0.5 g/kg glycine dissolved in water during 8 weeks.
795814|NCT01417481|E2|Reported Event|Placebo|Patients received a daily oral supplement of sugar glass at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
795815|NCT01417481|E1|Reported Event|Glycine|Patients received a daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks, dissolved in any liquid.
795816|NCT01417455|B9|Baseline|Total|Total of all reporting groups
795817|NCT01417455|B8|Baseline|Controls|Healthy donors age and sex matched to the patients
795818|NCT01417455|B7|Baseline|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
795819|NCT01417455|B6|Baseline|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
795820|NCT01417455|B5|Baseline|Ankylosing Spondylitis|Active Ankylosing Spondylitis
795821|NCT01417455|B4|Baseline|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
795822|NCT01417455|B3|Baseline|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
795823|NCT01417455|B2|Baseline|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
795824|NCT01417455|B1|Baseline|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
795825|NCT01417455|P8|Participant Flow|Controls|Healthy donors age and sex matched to the patients
795826|NCT01417455|P7|Participant Flow|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
795827|NCT01417455|P6|Participant Flow|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
795828|NCT01417455|P5|Participant Flow|Ankylosing Spondylitis|Active Ankylosing Spondylitis
795829|NCT01417455|P4|Participant Flow|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
795830|NCT01417455|P3|Participant Flow|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
795834|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
797601|NCT01408329|E1|Reported Event|Sham Group|Slowly fluctuating simulated altitude up to 607 meters.
795835|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
795836|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
795837|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
795838|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
795839|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
795840|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
795841|NCT01417455|O8|Outcome|Controls|Healthy donors age and sex matched to the patients
795842|NCT01417455|O7|Outcome|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
795843|NCT01417455|O6|Outcome|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
795844|NCT01417455|O5|Outcome|Ankylosing Spondylitis|Active Ankylosing Spondylitis
795845|NCT01417455|O4|Outcome|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
795846|NCT01417455|O3|Outcome|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
795847|NCT01417455|O2|Outcome|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
795848|NCT01417455|O1|Outcome|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
795849|NCT01417455|E8|Reported Event|Controls|Healthy donors age and sex matched to the patients - Healthy donors were not under any therapy therefore they were not at risk and Adverse effects were not assessed.
795850|NCT01417455|E7|Reported Event|Ankylosing Spondylitis With TNF-blockers|Ankylosing spondylitis recruited after a minimum of 6 months after the start of a TNF-blocker.
795851|NCT01417455|E6|Reported Event|Ankylosing Spondylitis Baseline for TNF Blocker|Patients with Ankylosing spondylitis naive to TNF-blockers, before the first TNF-block administration
795852|NCT01417455|E5|Reported Event|Ankylosing Spondylitis|Active Ankylosing Spondylitis
795853|NCT01417455|E4|Reported Event|Rheumatoid Arthritis With TNF-blockers|RA patients recruited at least 6 months after the start of a TNF-blocker
795854|NCT01417455|E3|Reported Event|Rheumatoid Arthritis Baseline for TNF-blockers|RA patients naive to TNF blockers recruited before the first administration of a TNF-blocker
795855|NCT01417455|E2|Reported Event|Rheumatoid Arthritis With DMARDs|Patients that started DMARD therapy after the Baseline collection
795856|NCT01417455|E1|Reported Event|Rheumatoid Arthritis|Active Rheumatoid Arthritis patients
795857|NCT01417377|B1|Baseline|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
795858|NCT01417377|P1|Participant Flow|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
795859|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
795860|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
795861|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
795862|NCT01417377|O1|Outcome|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
795863|NCT01417377|E1|Reported Event|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha were observed for a period of 6 months.
795864|NCT01417195|B3|Baseline|Total|Total of all reporting groups
795865|NCT01417195|B2|Baseline|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795866|NCT01417195|B1|Baseline|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795867|NCT01417195|P2|Participant Flow|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795868|NCT01417195|P1|Participant Flow|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795869|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
796230|NCT01414634|E1|Reported Event|ETIMS 1x10^3|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
795870|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795871|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795872|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795873|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795874|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795875|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795876|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795877|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur and administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795878|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795879|NCT01417195|O2|Outcome|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795880|NCT01417195|O1|Outcome|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795881|NCT01417195|E2|Reported Event|Menopur Alone|The initial daily dose consisted of 225 IU of Menopur administered by subcutaneous (SC) injection for 5 days. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and treatment could not continue beyond day 20.
795882|NCT01417195|E1|Reported Event|Menopur and Bravelle Combination|The initial daily dose consisted of 225 IU of gonadotropins, mixed in the same syringe and administered by subcutaneous (SC) injection for 5 days. The initial daily dose, based on the Investigator's judgment, consisted of either 150 IU of Menopur and 75 IU of Bravelle or 150 IU of Bravelle and 75 IU of Menopur. Dosing adjustments were allowed as of day 6. Dose could vary between 150-450 IU daily and was always to include at least 75 IU of Menopur and 75 IU of Bravelle. Treatment could not continue beyond day 20.
795883|NCT01417156|B1|Baseline|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
795884|NCT01417156|P1|Participant Flow|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
795885|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
795886|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
795887|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
795888|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
796231|NCT01414413|B3|Baseline|Total|Total of all reporting groups
795889|NCT01417156|O1|Outcome|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
795890|NCT01417156|E1|Reported Event|Nintedanib|Patients were treated orally with 150 milligram (mg) Nintedanib (BIBF 1120) twice daily (b.i.d.) on top of pre-existing Pirfenidone treatment with the opportunity to reduce the dose to 100 mg bid to manage adverse events.
795891|NCT01417104|B3|Baseline|Total|Total of all reporting groups
795892|NCT01417104|B2|Baseline|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
795893|NCT01417104|B1|Baseline|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
795894|NCT01417104|P2|Participant Flow|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
795895|NCT01417104|P1|Participant Flow|Aliskiren|Aliskiren will be administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
795896|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
795897|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
795898|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
795899|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
795900|NCT01417104|O2|Outcome|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
795901|NCT01417104|O1|Outcome|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
795902|NCT01417104|E2|Reported Event|Placebo|Placebo (sugar pill) built to mimic both the 150mg Aliskiren tablet ( administered for the first 2 weeks) and the 300mg Aliskiren tablet ( administered for the rest of treatment period)
795903|NCT01417104|E1|Reported Event|Aliskiren|Aliskiren was administered for 2 weeks at 150mg/day oral pill, followed by 34 weeks oral therapy with 300mg/day
795904|NCT01417078|B1|Baseline|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
795905|NCT01417078|P1|Participant Flow|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
795906|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration.
795907|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
795908|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration
795909|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
795910|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
795911|NCT01417078|O2|Outcome|Nordiazepam|Diazepam was slowly converted to nordiazepam following intranasal administration
795912|NCT01417078|O1|Outcome|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
795913|NCT01417078|E1|Reported Event|Diazepam Nasal Spray|Diazepam: single-dose; dosage in mg, based on patient body weight
795914|NCT01417026|B3|Baseline|Total|Total of all reporting groups
795915|NCT01417026|B2|Baseline|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795916|NCT01417026|B1|Baseline|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795917|NCT01417026|P2|Participant Flow|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795986|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
797054|NCT01410565|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
795918|NCT01417026|P1|Participant Flow|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795919|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795920|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795921|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795922|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795923|NCT01417026|O2|Outcome|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795924|NCT01417026|O1|Outcome|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795925|NCT01417026|E2|Reported Event|Intranasal Placebo|"Intranasal placebo~The placebo is identical to the oxytocin formulation with the exception of the active compound.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.~One dose equals 6 spray puffs (3 puffs in each nostril).~Placebo will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795987|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
797602|NCT01408303|B4|Baseline|Total|Total of all reporting groups
795926|NCT01417026|E1|Reported Event|Intranasal Oxytocin|"Intranasal oxytocin (Trade name: Syntocinon)~Pharmacological class: The pharmacologic and clinical properties of Syntocinon are identical with the naturally occurring hormone oxytocin, which is released from the posterior pituitary.~Route of administration: Intranasal~Planned exposure: Each participant will receive one dose of intranasal oxytocin (24 IU) per day for 5 days.~One dose of 24 IU equals 6 spray puffs (3 puffs in each nostril).~Oxytocin will be imported from Victoria Pharmacy Zurich- Switzerland.~Intranasal Oxytocin (Trade name: Syntocinon): This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period."
795927|NCT01416610|B1|Baseline|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795928|NCT01416610|P1|Participant Flow|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795929|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795930|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795931|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795932|NCT01416610|O4|Outcome|End of Follow-up|End of Follow-up Visit
795933|NCT01416610|O3|Outcome|End of Treatment|End of Treatment Visit
795934|NCT01416610|O2|Outcome|Week 12|Week 12 Visit
795935|NCT01416610|O1|Outcome|Baseline|Baseline Visit
795936|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795937|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795938|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795939|NCT01416610|O1|Outcome|All Participants|Participants with chronic hepatitis C, Genotype 2, 3, 1 or 4, undergoing an opioid maintenance therapy
795940|NCT01416610|E1|Reported Event|Safety Population|Participants who started treatment
795941|NCT01416571|B1|Baseline|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795942|NCT01416571|P1|Participant Flow|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795943|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795944|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795945|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795946|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795947|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795948|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795949|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795950|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795951|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795952|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795953|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795954|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795988|NCT01416142|O2|Outcome|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
795955|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795956|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795957|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795958|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795959|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795960|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795961|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795962|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795963|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795964|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795965|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795966|NCT01416571|O1|Outcome|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795967|NCT01416571|E1|Reported Event|Influenza A (H5N1) Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm.
795968|NCT01416272|B1|Baseline|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
795969|NCT01416272|P1|Participant Flow|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
795970|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
795971|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
795972|NCT01416272|O1|Outcome|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
795973|NCT01416272|E1|Reported Event|KeraSoft IC Soft Contact Lenses|"KeraSoft IC Soft Contact Lenses, with CIBA Clear Care solution provided for lens care~KeraSoft IC Soft Contact Lenses: Lenses will be worn between 8 and 16 hrs each day, for 12 months"
795974|NCT01416155|B1|Baseline|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
795975|NCT01416155|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions of natalizumab open label every 4 weeks
795976|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
795977|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
795978|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
795979|NCT01416155|O1|Outcome|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
795980|NCT01416155|E1|Reported Event|Natalizumab|300 mg IV infusions of natalizumab open label every 4 weeks
795981|NCT01416142|B1|Baseline|All Eligible Baseline Participants|Participants crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
795982|NCT01416142|P3|Participant Flow|PureVision2 HD|Following the movie participants wore PureVision2 HD lenses on a daily wear basis for one week.
795983|NCT01416142|P2|Participant Flow|Spectacles:PureVision2 HD|Participants crossed over from spectacle wear to PureVision2 HD contact lenses during the movie intermission.
795984|NCT01416142|P1|Participant Flow|PureVision2 HD:Spectacles|Participants:crossed over from PureVision2 HD contact lenses to spectacle wear during the movie intermission.
795985|NCT01416142|O3|Outcome|No Difference|Participants reporting no difference between the PureVision2 HD lens and spectacles
795989|NCT01416142|O1|Outcome|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses. The lower the mean logMAR the better the VA.
795990|NCT01416142|E2|Reported Event|Spectacles|The subject's habitual spectacles (updated or confirmed as correct within the last 2 years).
795991|NCT01416142|E1|Reported Event|PureVision2 Lenses|The currently marketed Bausch + Lomb PureVision2 HD contact lenses. Bausch + Lomb Biotrue® multi-purpose solution was dispensed with the lenses.
795992|NCT01416129|B3|Baseline|Total|Total of all reporting groups
795993|NCT01416129|B2|Baseline|Active Comparator: Prosthetic Brimless Socket|This is the experimental socket condition that includes lower trimlines, below the level of the ischial tuberosity.
795994|NCT01416129|B1|Baseline|Active Comparator: Prosthetic Socket Standard of Care|This socket is the standard of care and is defined by higher trimlines and a medial wall that contains the ischial tuberosity.
795995|NCT01416129|P2|Participant Flow|Prosthetic Socket (Experimental): Brimless Socket|5 subjects randomized to the experimental condition then, following assessment, crossed over to accommodate and re-test with the standard of care (ischial containment socket).
795996|NCT01416129|P1|Participant Flow|Standard of Care Prosthetic Socket (Ischial Containment)|In this crossover study, 5 subjects were randomized to continue using their ischial containment socket socket first. After assessment, subjects crossed over into the other condition.
795997|NCT01416129|O2|Outcome|Active Comparator/Experimental: Prosthetic Brimless Socket|
795998|NCT01416129|O1|Outcome|Control Condition: Prosthetic Socket Standard of Care|
795999|NCT01416129|E2|Reported Event|Standard of Care Socket|
796000|NCT01416129|E1|Reported Event|Vacuum Assisted Socket|
796001|NCT01416025|B3|Baseline|Total|Total of all reporting groups
796002|NCT01416025|B2|Baseline|Standard Dosing|Standard doses of voriconazole will be used
796003|NCT01416025|B1|Baseline|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
796004|NCT01416025|P2|Participant Flow|Standard Dosing|Standard doses of voriconazole will be used
796005|NCT01416025|P1|Participant Flow|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
796006|NCT01416025|O2|Outcome|Standard Dosing|Standard doses of voriconazole will be used
796007|NCT01416025|O1|Outcome|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
796008|NCT01416025|E2|Reported Event|Standard Dosing|Standard doses of voriconazole will be used
796009|NCT01416025|E1|Reported Event|Prospective TDM Arm|"Voriconazole dose will be adjusted based on per protocol obtained TDM levels~Prospective TDM Arm: Voriconazole dose will be adjusted based on per protocol obtained TDM levels"
796010|NCT01415986|B1|Baseline|Group 1|Interstitial Photodynamic Therapy (I-PDT)
796011|NCT01415986|P1|Participant Flow|Group 1|Interstitial Photodynamic Therapy (I-PDT). This subject was adminatred with 0.15 mg/kg Foscan on day 1. He was trtaed with I-PDT using 652-nm light at 20 J/cm, 4 days after the drug adminstration. He stayed in a outpatient facility for 3 more days and discharged home.
796012|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (I-PDT)
796013|NCT01415986|O1|Outcome|Group 1|Interstitial Photodynamic Therapy (PDT)
796014|NCT01415986|E1|Reported Event|Group 1|Interstitial Photodynamic Therapy (I-PDT)
796015|NCT01415960|B1|Baseline|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
796016|NCT01415960|P1|Participant Flow|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
796017|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
796018|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
796019|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
796020|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
796021|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
796022|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
796023|NCT01415960|O1|Outcome|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart.~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im (intramuscular) injection, twice during the study, three months apart."
796024|NCT01415960|E1|Reported Event|Leuprolide Acetate 22.5 mg Depot|"Leuprolide acetate 22.5 mg depot administered twice, 3 months apart~Leuprolide acetate 22.5 mg depot, GP-Pharm SA: Administered by im injection, twice during the study, three months apart"
796025|NCT01415921|B3|Baseline|Total|Total of all reporting groups
796050|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
797913|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
796026|NCT01415921|B2|Baseline|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796027|NCT01415921|B1|Baseline|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796028|NCT01415921|P2|Participant Flow|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796029|NCT01415921|P1|Participant Flow|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796030|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796031|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796032|NCT01415921|O2|Outcome|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796033|NCT01415921|O1|Outcome|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796034|NCT01415921|E2|Reported Event|Placebo|"Matching placebo forced titration 15-60 mg as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796035|NCT01415921|E1|Reported Event|Pyridostigmine Bromide|"Forced titration protocol 15-60 mg every 8 hours as tolerated~Pyridostigmine Bromide: 15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue."
796036|NCT01415908|B3|Baseline|Total|Total of all reporting groups
796037|NCT01415908|B2|Baseline|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796038|NCT01415908|B1|Baseline|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796039|NCT01415908|P2|Participant Flow|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796040|NCT01415908|P1|Participant Flow|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796041|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796042|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796043|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796044|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796045|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796046|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796047|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796048|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796049|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796051|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796052|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796053|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796054|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796055|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796056|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796057|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796058|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796059|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796060|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796061|NCT01415908|O2|Outcome|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796062|NCT01415908|O1|Outcome|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796063|NCT01415908|E2|Reported Event|Control Group|Control subjects received autogenous bone graft from iliac crest, with CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System) using TLIF surgical approach.
796064|NCT01415908|E1|Reported Event|Investigational Group|Investigational subjects received INFUSE® bone graft, with the CAPSTONE® Spinal System and posterior supplemental fixation (CD HORIZON® Spinal System) using TLIF surgical approach.
796065|NCT01415531|B3|Baseline|Total|Total of all reporting groups
796066|NCT01415531|B2|Baseline|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
796067|NCT01415531|B1|Baseline|Placebo|Dose-matched placebo
796068|NCT01415531|P2|Participant Flow|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
796069|NCT01415531|P1|Participant Flow|Placebo|Dose-matched placebo
796070|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
796071|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
796072|NCT01415531|O2|Outcome|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
796073|NCT01415531|O1|Outcome|Placebo|Dose-matched placebo
796074|NCT01415531|E2|Reported Event|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
796075|NCT01415531|E1|Reported Event|Placebo|Dose-matched placebo
796076|NCT01415518|B3|Baseline|Total|Total of all reporting groups
796077|NCT01415518|B2|Baseline|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796078|NCT01415518|B1|Baseline|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796079|NCT01415518|P2|Participant Flow|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796080|NCT01415518|P1|Participant Flow|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796081|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796082|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796083|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796084|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796085|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796086|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796229|NCT01414634|E2|Reported Event|ETIMS 1x10^5|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796087|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796088|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796089|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796090|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796091|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796092|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796093|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796094|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796095|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796096|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796097|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796098|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796099|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796100|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796101|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796102|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796103|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796104|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796105|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796106|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796107|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796108|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796109|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796110|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796111|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796112|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796113|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796114|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796115|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796116|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796117|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796118|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796119|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796120|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796121|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796122|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796123|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796124|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796125|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796126|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796127|NCT01415518|O2|Outcome|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796128|NCT01415518|O1|Outcome|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796129|NCT01415518|E2|Reported Event|Ipratropium + Theophylline SR|ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796130|NCT01415518|E1|Reported Event|Symbicort Turbuhaler + Ipratropium + Theophylline SR|Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to ipratropium (AtroventTM 20 μg/inhalation, 2 inhalations four times daily) + theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
796131|NCT01415453|B1|Baseline|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
796132|NCT01415453|P1|Participant Flow|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
796133|NCT01415453|O1|Outcome|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
796134|NCT01415453|E1|Reported Event|Retinitis Pigmentosa|Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
796135|NCT01415427|B5|Baseline|Total|Total of all reporting groups
796136|NCT01415427|B4|Baseline|QW-QW|BMN110 2.0 mg/kg/qw in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
796137|NCT01415427|B3|Baseline|QOW-QOW|BMN110 2.0 mg/kg/qow in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
796138|NCT01415427|B2|Baseline|PBO-QW|Placebo in MOR004 + BMN110 2.0 mg/kg/qw in MOR005
796139|NCT01415427|B1|Baseline|PBO-QOW|Placebo in MOR004 + BMN110 2.0 mg/kg/qow in MOR005
796140|NCT01415427|P4|Participant Flow|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796141|NCT01415427|P3|Participant Flow|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796142|NCT01415427|P2|Participant Flow|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796143|NCT01415427|P1|Participant Flow|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796144|NCT01415427|O5|Outcome|Total|All treatment groups
796145|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796146|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796147|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796148|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796149|NCT01415427|O5|Outcome|Total|All treatment groups
796150|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796193|NCT01415232|B1|Baseline|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
796151|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796152|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796153|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796154|NCT01415427|O5|Outcome|Total|All treatment groups
796155|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796156|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796157|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796158|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796159|NCT01415427|O5|Outcome|Total|All treatment groups
796160|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796161|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796162|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796163|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796164|NCT01415427|O5|Outcome|Total|All treatment groups
796165|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796166|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796167|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796168|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796169|NCT01415427|O5|Outcome|Total|All treatment groups
796170|NCT01415427|O4|Outcome|QW-QW|Weekly infusions of 2.0 mg/kg/week BMN 110 for a total of 24 consecutive weeks in MOR004 + Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796171|NCT01415427|O3|Outcome|QOW-QOW|Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796172|NCT01415427|O2|Outcome|PBO-QW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 +Weekly infusions of 2.0 mg/kg/week BMN 110 in MOR005
796173|NCT01415427|O1|Outcome|PBO-QOW|Weekly IV infusions of placebo solution for a total of 24 consecutive weeks in MOR004 + Biweekly infusions of 2.0 mg/kg/qow BMN 110 and infusions of placebo on alternating weeks in MOR005
796174|NCT01415427|E5|Reported Event|Total|Total
796175|NCT01415427|E4|Reported Event|QW-QW|QW-QW
796176|NCT01415427|E3|Reported Event|QOW-QOW|QOW-QOW
796177|NCT01415427|E2|Reported Event|PBO-QW|PBO-QW
796178|NCT01415427|E1|Reported Event|PBO-QOW|PBO-QOW
796179|NCT01415401|B1|Baseline|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
796180|NCT01415401|P1|Participant Flow|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
796181|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
796182|NCT01415401|O1|Outcome|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
796183|NCT01415401|E1|Reported Event|AZARGA|Brinzolamide 1% / timolol 0.5% maleate fixed combination, 1 drop self-administered in study eye(s) twice daily for 8 weeks (8AM and 8PM)
796184|NCT01415349|B1|Baseline|Safety Analysis Set|Safety Analysis Set defined as all subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
796185|NCT01415349|P2|Participant Flow|SSP-002358 + Omeprazole First|A single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 in treatment period 2
796186|NCT01415349|P1|Participant Flow|SSP-002358 First|A single dose of 1 mg SSP-002358 in treatment period 1, a washout period, then a single dose of 1 mg SSP-002358 + a single dose of 40 mg Omeprazole in treatment period 2
796187|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
796188|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
796189|NCT01415349|O2|Outcome|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
796190|NCT01415349|O1|Outcome|SSP-002358 Alone|All subjects that received only SSP-002358
796191|NCT01415349|E2|Reported Event|SSP-002358 + Omeprazole|All subjects that received SSP-002358 + Omeprazole
796192|NCT01415349|E1|Reported Event|SSP-002358 Alone|All subjects that received only SSP-002358
796194|NCT01415232|P1|Participant Flow|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
796195|NCT01415232|O1|Outcome|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth from the skin to the epidural space in morbidly obese parturients
796196|NCT01415232|E1|Reported Event|Ultrasound Measurement|Ultrasound using the Sonosite S-Nerve® US system (SonoSite, Bothell,WA) to measure depth to epidural space in morbidly obese parturients.
796197|NCT01414855|B1|Baseline|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796198|NCT01414855|P1|Participant Flow|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy (cyclophosphamide, doxorubicin, vincristine and prednisone) for 6 cycles.
796199|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796200|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796201|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796202|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796203|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796204|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796205|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796206|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796207|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796208|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796209|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796210|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796211|NCT01414855|O1|Outcome|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796212|NCT01414855|E1|Reported Event|Obinutuzumab + CHOP|Participants received 1000 mg obinutuzumab intravenously on Day 1 of each 21-day cycle for 8 cycles; during Cycle 1 administration also on Days 8 and 15. Participants also received standard CHOP therapy for 6 cycles.
796213|NCT01414634|B1|Baseline|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796214|NCT01414634|P8|Participant Flow|ETIMS 3x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796215|NCT01414634|P7|Participant Flow|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796216|NCT01414634|P6|Participant Flow|ETIMS 1x10^9|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796217|NCT01414634|P5|Participant Flow|ETIMS 5x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796218|NCT01414634|P4|Participant Flow|ETIMS 1x10^8|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796219|NCT01414634|P3|Participant Flow|ETIMS 1x10^7|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796220|NCT01414634|P2|Participant Flow|ETIMS 1x10^5|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796221|NCT01414634|P1|Participant Flow|ETIMS 1x10^3|ETIMS: injection of peptide-coupled peripheral blood mononuclear cell (PBMC) by i.v. infusion
796222|NCT01414634|O1|Outcome|ETIMS Dose Escalation|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796223|NCT01414634|E8|Reported Event|ETIMS 3x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796224|NCT01414634|E7|Reported Event|ETIMS 2.5x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796225|NCT01414634|E6|Reported Event|ETIMS 1x10^9|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796226|NCT01414634|E5|Reported Event|ETIMS 5x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796227|NCT01414634|E4|Reported Event|ETIMS 1x10^8|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796228|NCT01414634|E3|Reported Event|ETIMS 1x10^7|ETIMS: injection of peptide-coupled PBMC by i.v. infusion
796232|NCT01414413|B2|Baseline|Clinic-based ART Assessment and Initiation|8466 adults resident in 3397 households
796233|NCT01414413|B1|Baseline|Home Assessment and Initiation of ART|8194 adults resident in 3213 households
796234|NCT01414413|P2|Participant Flow|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
796235|NCT01414413|P1|Participant Flow|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
796236|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
796237|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
796238|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
796239|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
796240|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
796241|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
796242|NCT01414413|O2|Outcome|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
796243|NCT01414413|O1|Outcome|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
796244|NCT01414413|E2|Reported Event|Clinic-based ART Assessment and Initiation|Facility-based HIV care following HIV self-testing only
796245|NCT01414413|E1|Reported Event|Home Assessment and Initiation of ART|Optional home initiation of HIV care following HIV self-testing
796246|NCT01414205|B3|Baseline|Total|Total of all reporting groups
796247|NCT01414205|B2|Baseline|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796248|NCT01414205|B1|Baseline|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796249|NCT01414205|P2|Participant Flow|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796250|NCT01414205|P1|Participant Flow|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796251|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796252|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796253|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796254|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796255|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796256|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796257|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796258|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796259|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796260|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796261|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796262|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796291|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796292|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796263|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796264|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796265|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796266|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796267|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796268|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796269|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796270|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796271|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796272|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796273|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796274|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796275|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796276|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796277|NCT01414205|O2|Outcome|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796278|NCT01414205|O1|Outcome|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796279|NCT01414205|E2|Reported Event|Obinutuzumab 2000 mg|Participants received a 2000 mg IV infusion, on days 1 (split dose 100 mg Day 1, 900 mg Day 2 and 1000 mg Day 3), 8 and 15 of cycle 1 and day 1 of cycles 2 -8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796280|NCT01414205|E1|Reported Event|Obinutuzumab 1000 mg|Participants received a 1000 mg intravenous (IV) infusion, on days 1 (split dose 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1 and day 1 of cycles 2 - 8, 21 day cycles. All participants received corticosteroids IV prior to the initial dose.
796281|NCT01414192|B5|Baseline|Total|Total of all reporting groups
796282|NCT01414192|B4|Baseline|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796283|NCT01414192|B3|Baseline|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796284|NCT01414192|B2|Baseline|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796285|NCT01414192|B1|Baseline|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796286|NCT01414192|P4|Participant Flow|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796287|NCT01414192|P3|Participant Flow|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796288|NCT01414192|P2|Participant Flow|Ezetimibe Monotherpay With Prior Treatment|Enrolled participants with prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796289|NCT01414192|P1|Participant Flow|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796290|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
798040|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
796293|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796294|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796295|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796296|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796297|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796298|NCT01414192|O3|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796299|NCT01414192|O2|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796300|NCT01414192|O1|Outcome|Ezetimibe Monotherapy With or Without Prior Treatment|Enrolled participants with or without prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796301|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796302|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796303|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796304|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796305|NCT01414192|O3|Outcome|Ezetimibe Plus Statin or Ezetimibe/Simvastatin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin or were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796306|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796307|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796308|NCT01414192|O4|Outcome|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796309|NCT01414192|O3|Outcome|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796310|NCT01414192|O2|Outcome|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796311|NCT01414192|O1|Outcome|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796312|NCT01414192|E4|Reported Event|Ezetimibe/Simvastatin|Enrolled participants who were receiving ezetimibe and simavastatin fixed dose combination tablet (Inegy®).
796313|NCT01414192|E3|Reported Event|Ezetimibe Plus Statin|Enrolled participants who were being coadministered ezetimide (Ezetrol®) and another prescription statin or ezetimide with simvastatin
796314|NCT01414192|E2|Reported Event|Ezetimibe Monotherapy With Prior Treatment|Enrolled participants who had prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796315|NCT01414192|E1|Reported Event|Ezetimibe Monotherapy Without Prior Treatment|Enrolled participants who had no prior lipid-lowering therapy and were currently receiving Ezetimibe alone (Ezetrol®).
796316|NCT01414166|B3|Baseline|Total|Total of all reporting groups
796317|NCT01414166|B2|Baseline|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796318|NCT01414166|B1|Baseline|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796319|NCT01414166|P2|Participant Flow|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796320|NCT01414166|P1|Participant Flow|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796321|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796322|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796323|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796324|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796325|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796358|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796326|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796327|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796328|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796329|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796330|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796331|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796332|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796333|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796334|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796335|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796336|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796337|NCT01414166|O2|Outcome|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796338|NCT01414166|O1|Outcome|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796339|NCT01414166|E2|Reported Event|Placebo|Matching placebo to ERN/LRPT administered orally once daily for 16 weeks to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796340|NCT01414166|E1|Reported Event|ERN/LPRT|Extended-release niacin 1 g in combination with laropiprant 20 mg administered orally once daily for 4 weeks, followed by ERN 2 g LPRT 40 mg administered orally once daily for 12 weeks, to South and Southeast Asian participants with low HDL-C and low-to-moderate coronary heart disease risk.
796341|NCT01414153|B5|Baseline|Total|Total of all reporting groups
796342|NCT01414153|B4|Baseline|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796343|NCT01414153|B3|Baseline|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796344|NCT01414153|B2|Baseline|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796345|NCT01414153|B1|Baseline|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796346|NCT01414153|P4|Participant Flow|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796347|NCT01414153|P3|Participant Flow|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796348|NCT01414153|P2|Participant Flow|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796349|NCT01414153|P1|Participant Flow|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796350|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796351|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796352|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796353|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796354|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796355|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796356|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796357|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
798041|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
796359|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796360|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796361|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796362|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796363|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796364|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796365|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796366|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796367|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796368|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796369|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796370|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796371|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796372|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796373|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796374|NCT01414153|O4|Outcome|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796375|NCT01414153|O3|Outcome|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796376|NCT01414153|O2|Outcome|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796377|NCT01414153|O1|Outcome|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796378|NCT01414153|E4|Reported Event|Lucentis or Avastin or Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea followed by a sham injection; given monthly intravitreously for 4 months
796379|NCT01414153|E3|Reported Event|4.0 mg iSONEP & Lucentis/Avastin/Eylea|4.0 mg iSONEP followed by 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796380|NCT01414153|E2|Reported Event|0.5 mg iSONEP & Lucentis/Avastin/Eylea|0.5 mg iSONEP and 0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea; given monthly intravitreously for 4 months
796381|NCT01414153|E1|Reported Event|Monotherapy|4.0 mg iSONEP followed by sham injection; given monthly intravitreously for 4 months
796382|NCT01414114|B1|Baseline|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796383|NCT01414114|P1|Participant Flow|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796384|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
796385|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
796386|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796387|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
796388|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
796389|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796390|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
796391|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
796474|NCT01413542|O1|Outcome|Group 1|The effect of ACE and/or DPP4 inhibition on change in heart rate in response to substance P (SP) was evaluated.
796511|NCT01413191|P1|Participant Flow|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
796476|NCT01413542|O1|Outcome|Group 1 (Males)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
796392|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796393|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
796394|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
796395|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796396|NCT01414114|O3|Outcome|Baseline PTH > 700 pg/mL|Participants with baseline PTH > 700 pg/mL
796397|NCT01414114|O2|Outcome|Baseline PTH ≤ 700 pg/mL|Participants with baseline PTH ≤ 700 pg/mL
796398|NCT01414114|O1|Outcome|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796399|NCT01414114|E1|Reported Event|Etelcalcetide|Participants received etelcalcetide three times a week (TIW) administered by intravenous bolus injection at the end of each hemodialysis session for 12 weeks. The starting dose was 5 mg and may have been titrated every 4 weeks based on the preceding serum parathyroid hormone (PTH) and corrected calcium (cCa) levels to a maximum dose of 20 mg per hemodialysis session in order to achieve the targeted PTH range while maintaining serum calcium within an acceptable range.
796400|NCT01414036|B3|Baseline|Total|Total of all reporting groups
796401|NCT01414036|B2|Baseline|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
796402|NCT01414036|B1|Baseline|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
796403|NCT01414036|P2|Participant Flow|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
796404|NCT01414036|P1|Participant Flow|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
796405|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
796406|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
796407|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
796408|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
796409|NCT01414036|O2|Outcome|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
796410|NCT01414036|O1|Outcome|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
796411|NCT01414036|E2|Reported Event|Patient Navigation|"Patients in this arm will receive a low literacy smoking cessation educational brochure and a list of hospital and community resources for smoking cessation. Patients will also receive navigation from a trained navigator Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.~Patient navigation: Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period."
796475|NCT01413542|O2|Outcome|Group 1 (Females)|The effect of ACE inhibition and/or DPP4 inhibition on tPA release in response to bradykinin and substance P (SP) was evaluated.
796412|NCT01414036|E1|Reported Event|Enhanced Traditional Care Control|"This arm will receive a low literacy smoking cessation educational brochure, a list of hospital and community resources for smoking cessation, in addition to usual care.~Enhanced Traditional Care control: Educational brochure, list of hospital and community resources"
796413|NCT01413958|B3|Baseline|Total|Total of all reporting groups
796414|NCT01413958|B2|Baseline|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796415|NCT01413958|B1|Baseline|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796416|NCT01413958|P2|Participant Flow|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796417|NCT01413958|P1|Participant Flow|Phenylephrine|Phenylephrine hydrochloride, 30 mg extended-release tablets, one tablet every 12 hours for 7 days
796418|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796419|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796420|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796421|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796422|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796423|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796424|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796425|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796426|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796427|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796428|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796429|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796430|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796431|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796432|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride 30 mg extended release tablets, one dose every 12 hours for 7 days
796433|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796434|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796435|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796436|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796437|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796438|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796439|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796440|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796441|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796442|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796443|NCT01413958|O2|Outcome|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796444|NCT01413958|O1|Outcome|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796445|NCT01413958|E2|Reported Event|Placebo|Placebo to phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796446|NCT01413958|E1|Reported Event|Phenylephrine|Phenylephrine hydrochloride, 30-mg extended release tablets, one tablet every 12 hours for 7 days
796447|NCT01413750|B5|Baseline|Total|Total of all reporting groups
796448|NCT01413750|B4|Baseline|Phase II (Placebo)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796449|NCT01413750|B3|Baseline|Phase II (Vorinostat)|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796450|NCT01413750|B2|Baseline|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796451|NCT01413750|B1|Baseline|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796510|NCT01413191|B1|Baseline|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
796452|NCT01413750|P4|Participant Flow|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796453|NCT01413750|P3|Participant Flow|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796454|NCT01413750|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796455|NCT01413750|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796456|NCT01413750|O1|Outcome|Phase I|All patients enrolled on the Phase I (safety lead-in) portion of the study.
796457|NCT01413750|O2|Outcome|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796458|NCT01413750|O1|Outcome|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796459|NCT01413750|O2|Outcome|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796460|NCT01413750|O1|Outcome|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796461|NCT01413750|E4|Reported Event|Phase II: Placebo|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to placebo on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796462|NCT01413750|E3|Reported Event|Phase II: Vorinostat|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients randomized to 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Voninostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796463|NCT01413750|E2|Reported Event|Phase I: Dose Level 2|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 800 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796464|NCT01413750|E1|Reported Event|Phase I: Dose Level 1|"Patients receive A fixed dose of Carboplatin at AUC 6 mg/ml.min iv on day 0 of each cycle and Paclitaxel 200 mg/m2, iv on day 0 of each cycle. Patients also receive 600 mg QD of Vorinostat on days -2 to 2. Each cycle is 21 days.~Paclitaxel: Given IV~Carboplatin: Given IV~Vorinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies"
796465|NCT01413542|B3|Baseline|Total|Total of all reporting groups
796466|NCT01413542|B2|Baseline|Group 2|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
796467|NCT01413542|B1|Baseline|Group 1|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
796468|NCT01413542|P4|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo = Group 2|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
796469|NCT01413542|P3|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibition)=Group 2|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the forearm blood flow and tPA responses to brain natriuretic peptide (BNP) and glucagon-like receptor 1 (GLP-1).
796470|NCT01413542|P2|Participant Flow|Sitagliptin (DPP4 Inhibition) Then Placebo=Group 1|Participants first received Sitagliptin 200 mg then Placebo by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
796471|NCT01413542|P1|Participant Flow|Placebo Then Sitagliptin (DPP4 Inhibibition)=Group 1|Participants first received Placebo then Sitagliptin 200 mg by mouth one time on each of two study days. Two weeks separated each study day. Each study day examined the effect of vehicle and enalaprilat on the forearm blood flow and tPA responses to bradykinin and substance P.
796472|NCT01413542|O1|Outcome|Group 2|The effect of treatment (placebo vs. DPP4 inhibition) on venous GLP-1 levels during intra-arterial GLP-1 infusion.
796473|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
796477|NCT01413542|O2|Outcome|Group 2|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effect of study drug on FBF response to glucagon like peptide-1 (peptide 1) and brain natriuretic peptide (peptide 2) was studied.
796478|NCT01413542|O1|Outcome|Group 1|Participants were randomized to sitagliptin 200 mg (DPP4 inhibitor) vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat (ACE inhibitor) on forearm blood flow and tPA responses to bradykinin (peptide 1) and substance P (SP) (peptide 2) were studied.
796479|NCT01413542|E4|Reported Event|Group 2 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
796480|NCT01413542|E3|Reported Event|Group 2 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effect of brain natriuretic peptide and glucagon like receptor-1 (GLP-1) on forearm blood flow and tPA release was studied.
796481|NCT01413542|E2|Reported Event|Group 1 (Sitagliptin Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
796482|NCT01413542|E1|Reported Event|Group 1 (Placebo Arm)|Participants were randomized to sitagliptin 200 mg vs. placebo on each of two study days. On each study day, the effects of vehicle and enalaprilat on forearm blood flow and tPA responses to bradykinin and substance P were studied.
796483|NCT01413516|B3|Baseline|Total|Total of all reporting groups
796484|NCT01413516|B2|Baseline|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
796485|NCT01413516|B1|Baseline|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
796486|NCT01413516|P2|Participant Flow|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
796487|NCT01413516|P1|Participant Flow|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
796488|NCT01413516|O2|Outcome|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor along with varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
796489|NCT01413516|O1|Outcome|Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor along with placebo during 1st day of study~Placebo: Sugar pill without any active medication"
796490|NCT01413516|E2|Reported Event|Experimental: Varenicline|"Smoking counseling, Varenicline: Experimental~Interventions:~Behavioral: smoking counseling~Drug: varenicline~Smoking counseling: Counseling sessions provided by trained smoking counselor during 1st day of study along with 28 day supply of varenicline~Varenicline: Varenicline (an approved medication for smoking cessation)"
796491|NCT01413516|E1|Reported Event|Control: Sugar Pill Without Any Active Medication|"Smoking counseling, Placebo: Placebo comparator~Interventions:~Behavior: smoking counseling~Drug: placebo (sugar pill without any active medication)~Smoking counseling: Counseling sessions provided by a trained smoking counselor during 1st day of study along with 28 day supply of placebo~Placebo: Sugar pill without any active medication"
796492|NCT01413360|B1|Baseline|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
796493|NCT01413360|P1|Participant Flow|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
796494|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
796495|NCT01413360|O1|Outcome|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
796496|NCT01413360|E1|Reported Event|HD Vitamin C|"High dose vitamin C~High dose vitamin C: Vitamin C, 3g per day (tid), with meal, per oral with water 100mL"
796497|NCT01413204|B4|Baseline|Total|Total of all reporting groups
796498|NCT01413204|B3|Baseline|Placebo|TA-7284 Placebo, once daily for 24 weeks
796499|NCT01413204|B2|Baseline|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
796500|NCT01413204|B1|Baseline|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
796501|NCT01413204|P3|Participant Flow|Placebo|TA-7284 Placebo, once daily for 24 weeks
796502|NCT01413204|P2|Participant Flow|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
796503|NCT01413204|P1|Participant Flow|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
796504|NCT01413204|O3|Outcome|Placebo|TA-7284 Placebo, once daily for 24 weeks
796505|NCT01413204|O2|Outcome|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
796506|NCT01413204|O1|Outcome|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
796507|NCT01413204|E3|Reported Event|Placebo|TA-7284 Placebo, once daily for 24 weeks
796508|NCT01413204|E2|Reported Event|TA-7284 High|TA-7284 high dose, once daily for 24 weeks
796509|NCT01413204|E1|Reported Event|TA-7284 Low|TA-7284 low dose, once daily for 24 weeks
796512|NCT01413191|O1|Outcome|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
796545|NCT01412957|E1|Reported Event|Panitumumab Plus BSC|
796513|NCT01413191|E1|Reported Event|CixutumumabTreatment|Cixutumumab 10 mg/kg intravenous (IV) over 1 hour on days 1 and 15 for 4 week courses.
796514|NCT01412983|B1|Baseline|Overall Study|All 99 participants in study
796515|NCT01412983|P2|Participant Flow|Ciba Vision Soft Contact Lens Then Bausch+Lomb Test Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision lens:Bausch+Lomb Test Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796516|NCT01412983|P1|Participant Flow|Bausch+Lomb Test Lens Then Ciba Vision Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens:Ciba Vision Lens. Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796517|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796518|NCT01412983|O1|Outcome|Bausch + Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch + Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796519|NCT01412983|O2|Outcome|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796520|NCT01412983|O1|Outcome|Bausch+Lomb Test Lens|"Bausch+Lomb investigational soft contact lens~Bausch+Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch+Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796521|NCT01412983|E2|Reported Event|Ciba Vision Soft Contact Lens|"Ciba Vision Air Optix Aqua soft contact lens~Ciba Vision soft contact lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796522|NCT01412983|E1|Reported Event|Bausch & Lomb Test Lens|"Bausch + Lomb investigational soft contact lens~Bausch & Lomb Test lens: Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses."
796523|NCT01412957|B3|Baseline|Total|Total of all reporting groups
796524|NCT01412957|B2|Baseline|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796525|NCT01412957|B1|Baseline|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796526|NCT01412957|P2|Participant Flow|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796527|NCT01412957|P1|Participant Flow|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796528|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796529|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796530|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796531|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796532|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796533|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796534|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796535|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796536|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796537|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796538|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796539|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796540|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796541|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796542|NCT01412957|O2|Outcome|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796543|NCT01412957|O1|Outcome|Panitumumab + BSC|Participants received panitumumab administered intravenously 6 mg/kg every 14 days plus best supportive care (BSC) until disease progression, withdrawal of consent, death, or intolerance of study drug.
796544|NCT01412957|E2|Reported Event|BSC Alone|Participants received best supportive care until disease progression, withdrawal of consent, or death.
796547|NCT01412944|B2|Baseline|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796548|NCT01412944|B1|Baseline|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796549|NCT01412944|P6|Participant Flow|AIN457 300 mg - AIN457 10 mg/kg I.V.|
796550|NCT01412944|P5|Participant Flow|AIN457 150 mg - AIN457 10 mg/kg I.V.|
796551|NCT01412944|P4|Participant Flow|AIN457 300 mg - AIN457 300 mg s.c.|
796552|NCT01412944|P3|Participant Flow|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
796553|NCT01412944|P2|Participant Flow|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796554|NCT01412944|P1|Participant Flow|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796555|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796556|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796557|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796558|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796559|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796560|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796561|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796562|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796563|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796564|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796565|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796566|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796567|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796568|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796569|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796570|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796571|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796678|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796572|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796573|NCT01412944|O2|Outcome|AIN457 I.V.|During the I.V. period, participants received AIN457 10mg/kg I.V. at randomization, week 2 and week 4, and AIN457 placebo s.c. at randomization and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796574|NCT01412944|O1|Outcome|AIN457 Subcutaneous (s.c.)|During the intravenous (I.V.) period, participants received two 150 mg s.c. injections of AIN457 at randomization and week 4, and AIN457 placebo I.V. at randomization, week 2 and week 4. During the maintenance period, participants received 300 mg s.c. of open-label AIN457.
796575|NCT01412944|E12|Reported Event|Follow-up: AIN457 150 mg - 10 mg/kg i.v.|
796576|NCT01412944|E11|Reported Event|Follow-up: AIN457 150 mg - 300 mg s.c.|
796577|NCT01412944|E10|Reported Event|Follow-up: AIN457 300 mg - 10 mg/kg i.v.|
796578|NCT01412944|E9|Reported Event|Follow up: AIN457 300 mg - AIN457 300 mg s.c.|
796579|NCT01412944|E8|Reported Event|Entire Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
796580|NCT01412944|E7|Reported Event|Entire Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
796581|NCT01412944|E6|Reported Event|Entire Period: AIN457 300 mg - AIN457 300 mg s.c.|
796582|NCT01412944|E5|Reported Event|Entire Period: AIN457 150 mg - AIN457 300 mg s.c.|
796583|NCT01412944|E4|Reported Event|I.V. Period: AIN457 300 mg - AIN457 10 mg/kg i.v.|
796584|NCT01412944|E3|Reported Event|I.V. Period: AIN457 150 mg - AIN457 10 mg/kg i.v.|
796585|NCT01412944|E2|Reported Event|I.V. Period: AIN457 300 mg - AIN457 300 mg s.c.|
796586|NCT01412944|E1|Reported Event|I.V. Period: AIN457 150 mg - AIN457 300 mg s.c.|
796587|NCT01412918|B3|Baseline|Total|Total of all reporting groups
796588|NCT01412918|B2|Baseline|No Tinnitus|Individuals without tinnitus.
796589|NCT01412918|B1|Baseline|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
796590|NCT01412918|P2|Participant Flow|No Tinnitus|Individuals without tinnitus.
796591|NCT01412918|P1|Participant Flow|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
796592|NCT01412918|O2|Outcome|No Tinnitus|Individuals without tinnitus.
796593|NCT01412918|O1|Outcome|Tinnitus|"Individual with tinnitus.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
796594|NCT01412918|O1|Outcome|Tinnitus|Tinnitus. genetic sample collection (no intervention)
796595|NCT01412918|E2|Reported Event|No Tinnitus|Individuals without tinnitus.
796596|NCT01412918|E1|Reported Event|Tinnitus|"Individual with tinnitus. Intervention: inhibitor device demonstration.~The Inhibitor™ Tinnitus Masking Device: The Inhibitor™ Tinnitus Masking Device"
796597|NCT01412879|B3|Baseline|Total|Total of all reporting groups
796598|NCT01412879|B2|Baseline|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
796599|NCT01412879|B1|Baseline|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
796600|NCT01412879|P3|Participant Flow|Consolidation Therapy: Stem Cell Transplant|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
796601|NCT01412879|P2|Participant Flow|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
796602|NCT01412879|P1|Participant Flow|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
796644|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796809|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
796645|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796603|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
796604|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
796605|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
796606|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
796607|NCT01412879|O3|Outcome|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
796608|NCT01412879|O2|Outcome|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
796609|NCT01412879|O1|Outcome|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
796610|NCT01412879|O2|Outcome|Arm 2: R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
796611|NCT01412879|O1|Outcome|Arm 1: R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
796612|NCT01412879|E3|Reported Event|Stem Cell Transplant (Consolidation Therapy)|"Patients receive stem cell transplant with non-TBI containing regimen (BCV or BEAM Chemotherapy) for patients 61 years or older or TBI-containing regimen (TBI/VP-16/Cyclophosphamide). BCV chemotherapy: Carmustine IV over 2 hours on days -6 to -4; etoposide IV over 4 hours on day -4; and cyclophosphamide IV over 1 hour on day -2. BEAM chemotherapy: Carmustine IV over 4 hours on days -7 and -6; etoposide IV over 1 hour twice daily and cytarabine IV over 2 hours twice daily on days -5 to -2, and melphalan IV on day -1.~TBI, etoposide, cyclophosphamide: Patients undergo total-body irradiation (TBI)** twice daily on days -8 to -5. Patients also receive etoposide IV on day -4 and cyclophosphamide IV over 1 hour on day -2. * *TBI may not be used for patients 61 years of age and older. Stem cell transplantation: Patients then undergo autologous peripheral blood stem cell transplantation on day 0."
796613|NCT01412879|E2|Reported Event|R-Bendamustine (Induction Therapy)|R-bendamustine combinations are rituximab and bendamustine. Patients receive rituximab IV on day 1 and bendamustine hydrochloride IV over 30 minutes on days 1-2. Treatment repeats every 28 days for 4 cycles (1 cycle = 28 days). Patients with responsive disease receive 2 additional cycles of treatment. Patients undergo stem cell collection after completion of 6 Cycles of treatment.
796614|NCT01412879|E1|Reported Event|R-HCVAD/MTX/Ara-C (Induction Therapy)|The R-HCVAD/MTX/ARA-C combination are rituximab, cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, and cytarabine. Cycle 1 and 3: Patients receive induction therapy comprising rituximab IV on day 1; cyclophosphamide IV over 3 hours every 12 hours on days 2-4; doxorubicin hydrochloride IV over 72 hours on days 5-7; vincristine sulfate IV on days 5 and 12; and dexamethasone IV or orally (PO) once daily (QD) on days 2-5 and 12-15. Patients with responsive disease after course 1 proceed to course 2. Cycle 2 and 4: Patients receive rituximab IV on day 1; methotrexate IV over 2-22 hours on day 2; cytarabine IV over 2 hours every 12 hours on days 3-4; and leucovorin calcium PO or IV on days 3-6. Patients undergo stem cell collection after completion of Cycle 2 (1 cycle = 21 days).
796615|NCT01412801|B7|Baseline|Total|Total of all reporting groups
796616|NCT01412801|B6|Baseline|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
796617|NCT01412801|B5|Baseline|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
796618|NCT01412801|B4|Baseline|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
796619|NCT01412801|B3|Baseline|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796620|NCT01412801|B2|Baseline|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796621|NCT01412801|B1|Baseline|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796622|NCT01412801|P6|Participant Flow|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
796623|NCT01412801|P5|Participant Flow|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
796624|NCT01412801|P4|Participant Flow|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
796625|NCT01412801|P3|Participant Flow|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796626|NCT01412801|P2|Participant Flow|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796627|NCT01412801|P1|Participant Flow|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796628|NCT01412801|O3|Outcome|HIVneg|"Maternal subjects: HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.~Infants: Infants born to HIV-antibody negative maternal subjects"
796629|NCT01412801|O2|Outcome|HIVposCD4HIGH|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
796630|NCT01412801|O1|Outcome|HIVposCD4LOW|Maternal Subjects:HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine Infants:Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
796631|NCT01412801|O3|Outcome|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
796632|NCT01412801|O2|Outcome|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
796633|NCT01412801|O1|Outcome|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL
796634|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796635|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796636|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796637|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796638|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796639|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796640|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796641|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796642|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796643|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine.
796810|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
796646|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796647|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796648|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796649|NCT01412801|O6|Outcome|HIVneg(Infants)|Infants born to HIV-antibody negative maternal subjects
796650|NCT01412801|O5|Outcome|HIVposCD4HIGH(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/µL
796651|NCT01412801|O4|Outcome|HIVposCD4LOW(Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/µL but > 50 cells/µL .
796652|NCT01412801|O3|Outcome|HIVneg_Maternal|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796653|NCT01412801|O2|Outcome|HIVposCD4HIGH_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796654|NCT01412801|O1|Outcome|HIVposCD4LOW_Maternal|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/µL but > 50 cells/µL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent Vaccine
796655|NCT01412801|E8|Reported Event|Total Maternal Subjects|Total number of Maternal subjects participated in the study
796656|NCT01412801|E7|Reported Event|HIVneg_Maternal Subjects|HIV-antibody negative maternal subjects at 24 to 35 weeks gestation received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
796657|NCT01412801|E6|Reported Event|HIVposCD4HIGH_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count >350 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
796658|NCT01412801|E5|Reported Event|HIVposCD4LOW_Maternal Subjects|HIV-antibody positive maternal subjects at 24 to 35 weeks gestation with CD4+ count ≤350 cells/μL but > 50 cells/μL received one dose of 5 μg of each of the 3 glycoconjugates present in the GBS Trivalent vaccine.
796659|NCT01412801|E4|Reported Event|Total (Infants)|Total number of Infants participated in the study
796660|NCT01412801|E3|Reported Event|HIVneg (Infants)|Infants born to HIV-antibody negative maternal subjects
796661|NCT01412801|E2|Reported Event|HIVposCD4HIGH (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count >350 cells/μL .
796662|NCT01412801|E1|Reported Event|HIVposCD4LOW (Infants)|Infants born to HIV-antibody positive maternal subjects with CD4+ count ≤350 cells/μL but > 50 cells/μL
796663|NCT01412541|B3|Baseline|Total|Total of all reporting groups
796664|NCT01412541|B2|Baseline|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796665|NCT01412541|B1|Baseline|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796666|NCT01412541|P2|Participant Flow|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796667|NCT01412541|P1|Participant Flow|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796668|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796669|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796670|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796671|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796672|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796673|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796674|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796675|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796676|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796677|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796811|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
796679|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796680|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796681|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796682|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796683|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796684|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796685|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796686|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796687|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796688|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796689|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796690|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796691|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796692|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796693|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796694|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796695|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796696|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796697|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796698|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796699|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796700|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796701|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796702|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796703|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796704|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796705|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796706|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796707|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796708|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796812|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
796709|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796710|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796711|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796712|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796713|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796714|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796715|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796716|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796717|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796718|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796719|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796720|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796721|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796722|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796723|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796724|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796725|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796726|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796727|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796728|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796729|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796730|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796731|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796732|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796733|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796734|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796735|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796736|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796737|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796738|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796813|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
796739|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796740|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796741|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796742|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796743|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796744|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796745|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796746|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796747|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796748|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796749|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796750|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796751|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796752|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796753|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796754|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796755|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796756|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796757|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796758|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796759|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796760|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796761|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796762|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796763|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796764|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796765|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796766|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796767|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796768|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796814|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
796769|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796770|NCT01412541|O2|Outcome|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796771|NCT01412541|O1|Outcome|Lutonix 035 Drug Coated Balloon PTA Catheter (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796772|NCT01412541|E2|Reported Event|Standard Uncoated Angioplasty Balloon|"Control group: standard uncoated PTA catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796773|NCT01412541|E1|Reported Event|Lutonix 035 Drug Coated Balloon (Lutonix DCB)|"Test group: Formerly called the Moxy Drug Coated Balloon, the Lutonix DCB is a paclitaxel coated balloon catheter~Subjects were randomized 2:1 to the Lutonix DCB or standard angioplasty balloon."
796774|NCT01412424|B1|Baseline|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796775|NCT01412424|P1|Participant Flow|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796776|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796777|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796778|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796779|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796780|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796781|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796782|NCT01412424|O1|Outcome|Octreotide Capsules|Participants received octreotide capsules orally twice a day for up to 13 months. Dosing started at 40 mg per day (20 in the morning + 20 in the evening) and increased to 60 mg per day (40 in the morning + 20 in the evening) or 80 mg per day (40 in the morning + 40 in the evening) if there was inadequate IGF-1 suppression.
796783|NCT01412424|O4|Outcome|Octreotide 40, 60, or 80 mg - All Participants|Participants received octreotide 40, 60, or 80 mg orally for up to 13 months.
796784|NCT01412424|O3|Outcome|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
796785|NCT01412424|O2|Outcome|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
796786|NCT01412424|O1|Outcome|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
796787|NCT01412424|E3|Reported Event|Octreotide 80 mg|Participants received octreotide 40 mg in the morning and octreotide 40 mg in the evening orally for up to 13 months.
796788|NCT01412424|E2|Reported Event|Octreotide 60 mg|Participants received octreotide 40 mg in the morning and octreotide 20 mg in the evening orally for up to 13 months.
796789|NCT01412424|E1|Reported Event|Octreotide 40 mg|Participants received octreotide 20 mg orally twice a day for up to 13 months.
796790|NCT01412281|B5|Baseline|Total|Total of all reporting groups
796791|NCT01412281|B4|Baseline|>60 Years - CSL HA Antigen|
796792|NCT01412281|B3|Baseline|>60 Years - AdImmune HA Antigen|
796793|NCT01412281|B2|Baseline|≥18 to ≤60 Years - CSL HA Antigen|
796794|NCT01412281|B1|Baseline|≥18 to ≤60 Years - AdImmune HA Antigen|
796795|NCT01412281|P4|Participant Flow|>60 Years - CSL HA Antigen|
796796|NCT01412281|P3|Participant Flow|>60 Years - AdImmune HA Antigen|
796797|NCT01412281|P2|Participant Flow|≥18 to ≤60 Years - CSL HA Antigen|
796798|NCT01412281|P1|Participant Flow|≥18 to ≤60 Years - AdImmune HA Antigen|
796799|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
796800|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
796801|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
796802|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
796803|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
796804|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
796805|NCT01412281|O2|Outcome|≥18 to ≤60 Years - CSL HA Antigen|
796806|NCT01412281|O1|Outcome|≥18 to ≤60 Years - AdImmune HA Antigen|
796807|NCT01412281|O4|Outcome|>60 Years - CSL HA Antigen|
796808|NCT01412281|O3|Outcome|>60 Years - AdImmune HA Antigen|
796819|NCT01412164|B1|Baseline|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
797603|NCT01408303|B3|Baseline|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
796820|NCT01412164|P1|Participant Flow|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
796821|NCT01412164|O1|Outcome|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
796822|NCT01412164|E1|Reported Event|Firehawk|"Using Firehawk biodegradable polymer rapamycin-eluting stent for CAD~FIREHAWK biodegradable polymer rapamycin-eluting stent: DES PCI for CAD"
796823|NCT01412151|B1|Baseline|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
796824|NCT01412151|P1|Participant Flow|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
796825|NCT01412151|O1|Outcome|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
796826|NCT01412151|E1|Reported Event|Creatine Monohydrate|Twice daily with a meal mixed in a liquid for a total daily dosage of 30 grams. Daily dosage adjustments (e.g. reductions, suspensions, rechallenges) were allowed to manage adverse events.
796827|NCT01412086|B1|Baseline|All Participants|Healthy volunteers. No treatment (intervention) was received.
796828|NCT01412086|P1|Participant Flow|All Participants|Healthy volunteers. No treatment (intervention) was received.
796829|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
796830|NCT01412086|O1|Outcome|All Participants|Healthy volunteers. No treatment (intervention) was received.
796831|NCT01412086|E1|Reported Event|All Participants|Healthy volunteers. No treatment (intervention) was received.
796832|NCT01411891|B3|Baseline|Total|Total of all reporting groups
796833|NCT01411891|B2|Baseline|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796834|NCT01411891|B1|Baseline|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796835|NCT01411891|P2|Participant Flow|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796836|NCT01411891|P1|Participant Flow|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796837|NCT01411891|O2|Outcome|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796838|NCT01411891|O1|Outcome|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796839|NCT01411891|E2|Reported Event|Chlorhexidine Impregnated Patch.|Patients assigned to this study group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796840|NCT01411891|E1|Reported Event|Control|Patients assigned to this study group will not have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
796841|NCT01411852|B3|Baseline|Total|Total of all reporting groups
796842|NCT01411852|B2|Baseline|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796843|NCT01411852|B1|Baseline|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796844|NCT01411852|P2|Participant Flow|0.9% Sodium Chloride 250 mL Bolus|"0.9% Sodium Chloride 250 mL bolus - A large bore IV will be placed and a 250cc bag of normal saline (NS) will be hung. If IV placement is difficult, NS can be given through an intraosseous line. The procedure will continue until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.~0.9% Sodium Chloride 250 mL bolus: Either systolic blood pressure (SBP) or radial pulse is the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients receive 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS is given only to keep the vein open. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first."
796845|NCT01411852|P1|Participant Flow|0.9% Sodium Chloride 2000 mL Bolus|"0.9% Sodium Chloride 2000 mL bolus - An intravenous line (IV) will be placed and a 1000cc bag of normal saline will be hung. If IV placement is difficult, fluid can be given through an intraosseous line. This procedure will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.~0.9% Sodium Chloride 2000 mL bolus: The systolic blood pressure (SBP) is the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. Once the total fluid reaches 2 liters and the SBP exceeds 110 mmHg, the fluid will be stopped and restarted as necessary to maintain a goal SBP of 110 mmHg."
796846|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796847|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796848|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796849|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796850|NCT01411852|O2|Outcome|Controlled Resuscitation|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796851|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796852|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796853|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796854|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796855|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796856|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796857|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796858|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796859|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796860|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796861|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796862|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796863|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796864|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796865|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796866|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796867|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796868|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796869|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796870|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796871|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796872|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796873|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796874|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796875|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796876|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796877|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796878|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796879|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796880|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796881|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796882|NCT01411852|O3|Outcome|ECV Difference [Standard - Controlled]|ECV treatment difference between SR and CR
796883|NCT01411852|O2|Outcome|Controlled Resuscitation (CR)|Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.
796884|NCT01411852|O1|Outcome|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796885|NCT01411852|E2|Reported Event|Controlled Resuscitation (CR)|"Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was < 70 millimeters of mercury (mmHg) or they had no palpable radial pulse.~The total number of patients at risk is one less than the total number of patients enrolled. Regulatory restrictions for prisoners required that no data collection, including severe adverse events, be performed for the patient who was determined to have been in police custody at the time of enrollment."
796886|NCT01411852|E1|Reported Event|Standard Resuscitation (SR)|Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period.
796887|NCT01411696|B1|Baseline|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
796888|NCT01411696|P1|Participant Flow|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
796889|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
796890|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
796891|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
796892|NCT01411696|O1|Outcome|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
796893|NCT01411696|E1|Reported Event|All Participants|Patients who received at least 2 injections of OZURDEX® (dexamethasone intravitreal implant) to treat Macular Edema.
796894|NCT01411592|B3|Baseline|Total|Total of all reporting groups
796895|NCT01411592|B2|Baseline|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
796896|NCT01411592|B1|Baseline|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
796897|NCT01411592|P2|Participant Flow|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
796898|NCT01411592|P1|Participant Flow|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
796899|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
796900|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
796959|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796960|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796970|NCT01411215|P2|Participant Flow|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796901|NCT01411592|O2|Outcome|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
796902|NCT01411592|O1|Outcome|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
796903|NCT01411592|E2|Reported Event|Panavia 21 TC|"16 RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Panavia 21 TC: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer.~Patients were recalled after 6 and 12 months, and then annually."
796904|NCT01411592|E1|Reported Event|Multilink|"14 RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system [A/B primer and Multilink-Automix] with Metal/Zirconia primer).~Multilink bonding: After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer).~Patients were recalled after 6 and 12 months, and then annually."
796905|NCT01411501|B5|Baseline|Total|Total of all reporting groups
796906|NCT01411501|B4|Baseline|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796907|NCT01411501|B3|Baseline|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796908|NCT01411501|B2|Baseline|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796909|NCT01411501|B1|Baseline|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796910|NCT01411501|P4|Participant Flow|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796911|NCT01411501|P3|Participant Flow|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796912|NCT01411501|P2|Participant Flow|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796961|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
796962|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796963|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796964|NCT01411228|E3|Reported Event|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
796965|NCT01411228|E2|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796913|NCT01411501|P1|Participant Flow|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796914|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796915|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796916|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796917|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796918|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796919|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796920|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796921|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796922|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796923|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796966|NCT01411228|E1|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796967|NCT01411215|B3|Baseline|Total|Total of all reporting groups
797204|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
796924|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796925|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796926|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796927|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796928|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796929|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796930|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796931|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796932|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796933|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796934|NCT01411501|O4|Outcome|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796968|NCT01411215|B2|Baseline|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796969|NCT01411215|B1|Baseline|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796935|NCT01411501|O3|Outcome|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796936|NCT01411501|O2|Outcome|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796937|NCT01411501|O1|Outcome|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796938|NCT01411501|E4|Reported Event|Medicine|"oral use of mosapride citrate~mosapride citrate: 4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal"
796939|NCT01411501|E3|Reported Event|Acupuncture at ST25, BL25, LI11 and ST37|"the formula of He-point,back-shu point and front-mu point~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796940|NCT01411501|E2|Reported Event|Acupuncture at LI11 and ST37|"the points formula of He-points~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796941|NCT01411501|E1|Reported Event|Acupuncture at ST25 and BL25|"the points formula of back-shu point combination with front-mu point.~acupuncture: Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
796942|NCT01411228|B4|Baseline|Total|Total of all reporting groups
796943|NCT01411228|B3|Baseline|Dose Adjusted|Taliglucerase alfa: Dose increased from 30 Units/kg to 45 or 60 Units/kg
796944|NCT01411228|B2|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796945|NCT01411228|B1|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796946|NCT01411228|P3|Participant Flow|Switchover|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796947|NCT01411228|P2|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796948|NCT01411228|P1|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796949|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
796950|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796951|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796952|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
796953|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796954|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796955|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
796956|NCT01411228|O2|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796957|NCT01411228|O1|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 24 months
796958|NCT01411228|O3|Outcome|Switchover|Taliglucerase alfa: Maintained dose from PB-06-002 study
797053|NCT01410565|P3|Participant Flow|Open Label-Apaziquone|
796971|NCT01411215|P1|Participant Flow|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796972|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796973|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796974|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796975|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796976|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796977|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796978|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796979|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796980|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796981|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796982|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796983|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796984|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796985|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796986|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796987|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796988|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796989|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796990|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796991|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796992|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796993|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796994|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796995|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796996|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796997|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796998|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
796999|NCT01411215|O2|Outcome|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
797000|NCT01411215|O1|Outcome|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
797001|NCT01411215|E2|Reported Event|Ankylosing Spondylitis [AS]|Participants with AS who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
797002|NCT01411215|E1|Reported Event|Rheumatoid Arthritis [RA]|Participants with RA who received etanercept 25 mg twice weekly or 50 mg weekly per standard medical practice were observed for 52 weeks
797003|NCT01411137|B1|Baseline|All Study Participants|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.~Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, an additional 6-month open-label extension study."
797004|NCT01411137|P1|Participant Flow|IPX066|extended-release CD-LD
797055|NCT01410565|P1|Participant Flow|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
797056|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
797005|NCT01411137|O5|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
797006|NCT01411137|O4|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
797007|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
797008|NCT01411137|O2|Outcome|Part 1: Conversion (Week 6)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
797009|NCT01411137|O1|Outcome|Part 1: Conversion (Baseline)|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
797010|NCT01411137|O4|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
797011|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
797012|NCT01411137|O2|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
797013|NCT01411137|O1|Outcome|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
797014|NCT01411137|O4|Outcome|Part 1 or 2 Early Termination|"Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.~Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study."
797015|NCT01411137|O3|Outcome|Part 2: Open-Label Extension (Month 6)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
797016|NCT01411137|O2|Outcome|Part 2: Open-Label Extension (Month 3)|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
797017|NCT01411137|O1|Outcome|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
797018|NCT01411137|E4|Reported Event|Overall|All treated subjects
797019|NCT01411137|E3|Reported Event|Part 3: Open-Label Extension 2|Following the successful completion of Part 2 of the study, eligible subjects could participate in Part 3, a 6-month open-label extension study.
797020|NCT01411137|E2|Reported Event|Part 2: Open-Label Extension 1|Following the successful completion of Part 1 of the study, eligible subjects could participate in Part 2, a 6-month open-label extension study.
797021|NCT01411137|E1|Reported Event|Part 1: Conversion|Subjects converted from their previous CD-LD treatment to IPX066 over a 6-week period.
797022|NCT01410773|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
797023|NCT01410773|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
797024|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
797025|NCT01410773|O1|Outcome|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
797026|NCT01410773|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.~Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor."
797027|NCT01410604|B3|Baseline|Total|Total of all reporting groups
797028|NCT01410604|B2|Baseline|Placebo|
797029|NCT01410604|B1|Baseline|Metformin|
797030|NCT01410604|P2|Participant Flow|Placebo|
797031|NCT01410604|P1|Participant Flow|Metformin|
797032|NCT01410604|O2|Outcome|Placebo|
797033|NCT01410604|O1|Outcome|Metformin|
797034|NCT01410604|O2|Outcome|Placebo|
797035|NCT01410604|O1|Outcome|Metformin|
797036|NCT01410604|O2|Outcome|Placebo|
797037|NCT01410604|O1|Outcome|Metformin|
797038|NCT01410604|O2|Outcome|Placebo|
797039|NCT01410604|O1|Outcome|Metformin|
797040|NCT01410604|O2|Outcome|Placebo|
797041|NCT01410604|O1|Outcome|Metformin|
797042|NCT01410604|O2|Outcome|Placebo|
797043|NCT01410604|O1|Outcome|Metformin|
797044|NCT01410604|O2|Outcome|Placebo|
797045|NCT01410604|O1|Outcome|Metformin|
797046|NCT01410604|O2|Outcome|Placebo|
797047|NCT01410604|O1|Outcome|Metformin|
797048|NCT01410604|E2|Reported Event|Placebo|
797049|NCT01410604|E1|Reported Event|Metformin|
797050|NCT01410565|B3|Baseline|Total|Total of all reporting groups
797051|NCT01410565|B2|Baseline|Placebo|"Placebo~Placebo in the Double Blind Phase"
797052|NCT01410565|B1|Baseline|Apaziquone|"Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
797057|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
797058|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
797059|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
797060|NCT01410565|O2|Outcome|Placebo|"Placebo~Placebo in the Double Blind Phase"
797061|NCT01410565|O1|Outcome|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone in the Double Blind Phase"
797062|NCT01410565|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo in the Double Blind Phase"
797063|NCT01410565|E1|Reported Event|Apaziquone|"Apaziquone: Apaziquone 4 mg in 40 mL diluent~Apaziquone: Apaziquone in the Double Blind Phase"
797064|NCT01410474|B3|Baseline|Total|Total of all reporting groups
797065|NCT01410474|B2|Baseline|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797066|NCT01410474|B1|Baseline|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797067|NCT01410474|P2|Participant Flow|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797068|NCT01410474|P1|Participant Flow|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797069|NCT01410474|O3|Outcome|Overall (6-18 Years)|Subjects 6-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
797070|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
797071|NCT01410474|O1|Outcome|6-10 Years|Subjects 6-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
797072|NCT01410474|O1|Outcome|2-5 Years|Subjects 2-5 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1
797073|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797074|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797075|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797076|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797077|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797078|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797079|NCT01410474|O3|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797080|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797081|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797082|NCT01410474|O2|Outcome|11-18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797083|NCT01410474|O1|Outcome|2-10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797084|NCT01410474|O1|Outcome|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797085|NCT01410474|E3|Reported Event|Overall (2 to 18 Years)|Subjects 2 to 18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797086|NCT01410474|E2|Reported Event|11–18 Years|Subjects 11-18 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797087|NCT01410474|E1|Reported Event|2–10 Years|Subjects 2-10 years of age received one 0.5 mL dose of MenACWY-CRM vaccination as intramuscular (IM) injection at Day 1.
797088|NCT01410448|B3|Baseline|Total|Total of all reporting groups
797089|NCT01410448|B2|Baseline|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797090|NCT01410448|B1|Baseline|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797091|NCT01410448|P2|Participant Flow|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797092|NCT01410448|P1|Participant Flow|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797093|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797094|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797518|NCT01408719|B19|Baseline|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
797354|NCT01409837|P2|Participant Flow|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill taken once daily. Then crossed over to Lisinopril 2.5 mg taken once a day.
797863|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797095|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797096|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797097|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797098|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797099|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797100|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797101|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797102|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797103|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797104|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797105|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797106|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797107|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797108|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797109|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797110|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797111|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797112|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797113|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797114|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797115|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797116|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797117|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797118|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797119|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797120|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797121|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797122|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797123|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797124|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797125|NCT01410448|O2|Outcome|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797126|NCT01410448|O1|Outcome|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797127|NCT01410448|E2|Reported Event|Delayed Everolimus (DE)|The standard dose of mycophenolate sodium was administered within 48 hours after graft reperfusion in combination with a full dose of cyclosporine and steroids. After28 +/- 4 days of treatment, mycophenolate sodium was discontinued and everolimus was introduced at a starting dose of 0.75 mg twice daily for 3 months.
797128|NCT01410448|E1|Reported Event|Immediate Everolimus (IE)|Everolimus was started within 48 hours after graft reperfusion at a starting dose of 0.75 mg twice daily in combination with low-dose cyclosporine and steroids for 3 months.
797129|NCT01410409|B3|Baseline|Total|Total of all reporting groups
797130|NCT01410409|B2|Baseline|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797131|NCT01410409|B1|Baseline|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797132|NCT01410409|P2|Participant Flow|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797133|NCT01410409|P1|Participant Flow|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797168|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797169|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797170|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797134|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797135|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797136|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797137|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797138|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797139|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797140|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797141|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797171|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797172|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797142|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797143|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797144|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797145|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797146|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797147|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797148|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797149|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797173|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797174|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797150|NCT01410409|O2|Outcome|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797151|NCT01410409|O1|Outcome|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797152|NCT01410409|E2|Reported Event|MEDIC + TKR|"TKR: Surgical treatment with insertion of total knee replacement following standard procedures.~Followed by:~60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797153|NCT01410409|E1|Reported Event|MEDIC|"60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.~Paracetamol: 1 g x 4/day~Burana: 400 mg x 3/day~Pantoprazol: 20mg x 1/day~Dietary counseling: For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet.~Patient education: The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA.~Insoles: The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral)."
797154|NCT01410240|B4|Baseline|Total|Total of all reporting groups
797155|NCT01410240|B3|Baseline|FLOSEAL + Standard of Care (SoC) - Run-In|"Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL.~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
797156|NCT01410240|B2|Baseline|FLOSEAL + Standard of Care (SoC) - Non-Run-In|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~Standard of Care: Conventional hemostatic techniques, such as cautery and manual compression"
797157|NCT01410240|B1|Baseline|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797158|NCT01410240|P3|Participant Flow|FLOSEAL + Standard of Care (SoC) Run-In Participants|"This arm/group only includes the 12 initial run-in participants (one for each site permitted to familiarize the investigators with the study procedures and the use of FLOSEAL)~FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797159|NCT01410240|P2|Participant Flow|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797160|NCT01410240|P1|Participant Flow|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797161|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797162|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797163|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797164|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797165|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797166|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797167|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797175|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797519|NCT01408719|B18|Baseline|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
797176|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797177|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797178|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
797179|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797180|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
797181|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797182|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC) Including Run-In Participants|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression.~Run-In = The first participant who qualified for surgery at each site was treated with FLOSEAL + SoC to allow the investigator to familiarize with the study procedures and the use of FLOSEAL."
797183|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797184|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797185|NCT01410240|O2|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797186|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797187|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797188|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797189|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797190|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797191|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797192|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797193|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797194|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797195|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797196|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797197|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797198|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797199|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797200|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797201|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797202|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797203|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797205|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797206|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797207|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797208|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797209|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797210|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797211|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797212|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797213|NCT01410240|O1|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797214|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797215|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797216|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797217|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797218|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797219|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797220|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797221|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797222|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797223|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797224|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797225|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797226|NCT01410240|O2|Outcome|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797227|NCT01410240|O1|Outcome|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797228|NCT01410240|E2|Reported Event|Standard of Care (SoC)|SoC: conventional hemostatic techniques such as cautery and manual compression
797229|NCT01410240|E1|Reported Event|FLOSEAL + Standard of Care (SoC)|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed. FLOSEAL consists of bovine-derived gelatin granules and a human plasma-derived thrombin component.~SoC: conventional hemostatic techniques such as cautery and manual compression."
797230|NCT01410227|B1|Baseline|All Subjects Treated With Study Product|All subjects treated with study product
797231|NCT01410227|P4|Participant Flow|Arm 4: Treatment Only|In Part A, participants received on-demand treatment for bleeding episodes (BEs) with study product (recombinant von Willebrand Factor [rVWF] administered together with recombinant Factor VIII [rFVIII] (rVWF:rFVIII) or rVWF alone), where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels. If not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months. No pharmacokinetic (PK) assessments were conducted in this arm.
797248|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797520|NCT01408719|B17|Baseline|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
797232|NCT01410227|P3|Participant Flow|Arm 3: PK80 + Treatment|In Part A, participants initially underwent a first PK assessment of an infusion of 80 IU/kg recombinant von Willebrand Factor Ristocetin cofactor (VWF:RCo rVWF) [rVWF]. After the first PK assessment participants received on demand treatment for bleeding episodes (BEs) with study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rWVF with or without rFVIII, based on FVIII levels. If FVIII levels not available, the individual participant's PK data was used to determine rFVIII dose at discretion of investigator. Participants received on-demand treatment for 6 months after the first study product infusion. After 6 months participants underwent a second PK assessment of an infusion of 80 IU/kg rVWF. In part B, participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
797233|NCT01410227|P2|Participant Flow|Arm 2: PK50 Only|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). Participants then exited the study or could opt to sign informed consent to move to Arm 1 receive treatment for bleeding episodes with study product.
797234|NCT01410227|P1|Participant Flow|Arm 1: PK50 + Treatment|In Part A, (pharmacokinetic [PK] assessment followed by on-demand treatment for bleeding episodes [BEs] for 6 months) participants were initially infused either with 50 IU/kg recombinant von Willebrand Factor:von Willebrand Ristocetin cofactor (VWF:RCo rVWF) [rVWF] administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline. Participants then crossed over to the alternate infusion after washout (PK). For on-demand treatment, participants received study product [VWF:rFVIII or rVWF], where BEs were initially treated with rVWF:rFVIII and subsequently with rVWF with or without rFVIII, based on FVIII levels (dose based on previous FVIII levels or if not available from the individual participant's PK data at discretion of investigator). In part, B participants continued to receive on-demand treatment for BEs with study product [VWF:rFVIII or rVWF] for a further 6 months.
797235|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797236|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797237|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797238|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797239|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797240|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797241|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797242|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797243|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797244|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797245|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797246|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797247|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797249|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797250|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797251|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797252|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797253|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797254|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797255|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797256|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797257|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797258|NCT01410227|O1|Outcome|PK80 Arm|Comprised of participants who underwent PK analysis of study product (80 IU/kg recombinant von Willebrand Factor [rVWF]) i.e. participants from Arm 3 [PK80+Treatment]. Participants in this arm have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included in this arm.
797259|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797260|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797261|NCT01410227|O1|Outcome|Overall Study Arm|
797262|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797263|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797264|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797265|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797266|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797521|NCT01408719|B16|Baseline|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
797267|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797268|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797269|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797270|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797271|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797272|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797273|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797274|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797275|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797276|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797277|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797278|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797279|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797280|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
798042|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
797281|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797282|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797283|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797284|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797285|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797286|NCT01410227|O1|Outcome|PK50 Arms|Comprised of participants who underwent PK analysis of study product (50 IU/kg recombinant von Willebrand Factor (rVWF) administered together with 38.5 IU/kg recombinant Factor VIII (rFVIII) [rVWF:rFVIII] or 50 IU/kg rVWF administered together with saline [rVWF]) i.e. a total of participants from Arm 1 [PK50+Treatment] and Arm 2 [PK50 only]. Participants in the PK50 arms have received at least one PK infusion and have provided data suitable for PK analysis. Only PK data included from the PK50 arms.
797287|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797288|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797289|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797290|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797291|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797292|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797293|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797294|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797295|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797296|NCT01410227|O1|Outcome|Safety Analysis Set|Comprised of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797297|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
797298|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
797299|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
797300|NCT01410227|O1|Outcome|Full Analysis Set|Comprised of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
797301|NCT01410227|O1|Outcome|Full Analysis Set|Comprises of participants treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) for whom at least one efficacy rating scale was available.
797302|NCT01410227|E1|Reported Event|Safety Analysis Set|Comprises of participants who were treated with study product (recombinant von Willebrand Factor [rVWF] with or without recombinant factor VIII [rFVIII]) at least once during the study.
797303|NCT01410110|B3|Baseline|Total|Total of all reporting groups
797304|NCT01410110|B2|Baseline|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797305|NCT01410110|B1|Baseline|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797306|NCT01410110|P2|Participant Flow|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797307|NCT01410110|P1|Participant Flow|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797308|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797309|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797310|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797311|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797312|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797313|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797314|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797315|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797316|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797317|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797318|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797319|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797320|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797321|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797322|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797323|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797324|NCT01410110|O2|Outcome|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797325|NCT01410110|O1|Outcome|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797326|NCT01410110|E2|Reported Event|Work Therapy Only|"Same work therapy but for 20 hours per week.~Work Therapy: 20 hours per week of work therapy"
797327|NCT01410110|E1|Reported Event|Cognitive Training + Work Therapy|"Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.~Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.~Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy"
797328|NCT01409993|B3|Baseline|Total|Total of all reporting groups
797329|NCT01409993|B2|Baseline|Placebo|"matching placebo p.o. tid~Administration of placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil or placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
798043|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
797330|NCT01409993|B1|Baseline|Sildenafil|"sildenafil 25 mg p.o. tid~Administration of sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) clamp and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797331|NCT01409993|P4|Participant Flow|Placebo Aim 2|Administration of Placebo: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
797332|NCT01409993|P3|Participant Flow|Sildenafil Aim 2|Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperinsulinemic euglycemic (Aim 2) and then receive sildenafil for 3 months. Another euglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test.
797333|NCT01409993|P2|Participant Flow|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797334|NCT01409993|P1|Participant Flow|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797335|NCT01409993|O4|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797336|NCT01409993|O3|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797337|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797338|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797339|NCT01409993|O4|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797340|NCT01409993|O3|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Sildenafil: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797341|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797342|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil : Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797343|NCT01409993|O2|Outcome|Placebo Aim 2|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797344|NCT01409993|O1|Outcome|Sildenafil Aim 2|"sildenafil 25 mg p.o. tid~Administration of Sildenafil : Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797345|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797346|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797347|NCT01409993|O2|Outcome|Placebo Aim 1|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797348|NCT01409993|O1|Outcome|Sildenafil Aim 1|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797349|NCT01409993|E2|Reported Event|Placebo - Aims 1 and 2|"matching placebo p.o. tid~Administration of Placebo: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive placebo for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797350|NCT01409993|E1|Reported Event|Sildenafil - Aims 1 and 2|"sildenafil 25 mg p.o. tid~Administration of Sildenafil: Subjects with prediabetes will have a baseline hyperglycemic (Aim 1) or a euglycemic (Aim 2) and then receive sildenafil for 3 months. Another hyperglycemic or euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test."
797351|NCT01409837|B3|Baseline|Total|Total of all reporting groups
797352|NCT01409837|B2|Baseline|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797353|NCT01409837|B1|Baseline|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797355|NCT01409837|P1|Participant Flow|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril 2.5 mg taken once a day. Then crossed over to Sugar Pill taken also once a day. The Lisinopril and the Sugar Pill were made indistinguishable in appearance.
797356|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797357|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797358|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797359|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797360|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797361|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797362|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797363|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797364|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797365|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797366|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
797367|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
797368|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, then crossed over to Lisinopril
797369|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, then crossed over to Sugar Pill
797370|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797371|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797372|NCT01409837|O2|Outcome|Group A (Placebo First, Then Lisinopril)|Started with Sugar Pill, crossed over to Lisinopril
797373|NCT01409837|O1|Outcome|Group B (Lisinopril First, Then Placebo)|Started with Lisinopril, crossed over to Placebo
797374|NCT01409837|E2|Reported Event|Events Reported During Treatment With Placebo|All the events reported by patients in either group A or group B while receiving the Sugar Pill.
797375|NCT01409837|E1|Reported Event|Events Reported During Treatment With Lisinopril|All the events reported by patients in either group A or group B while receiving Lisinopril.
797376|NCT01409707|B4|Baseline|Total|Total of all reporting groups
797377|NCT01409707|B3|Baseline|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting the trauma-focused exposure therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797378|NCT01409707|B2|Baseline|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797379|NCT01409707|B1|Baseline|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
797380|NCT01409707|P3|Participant Flow|Motivational Enhancement + Trauma-focused Exposure Therapy|A one session, 90 min. trauma-focused motivational enhancement therapy session was provided prior to starting exposure therapy. Exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for exposure therapy, and were taught breathing retraining as a method to manage arousal associated with posttraumatic stress disorder. Nine to 12 50-60 minutes sessions were provided.
797381|NCT01409707|P2|Participant Flow|Trauma-focused Exposure Therapy|Trauma-focused exposure therapy is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of posttraumatic stress disorder. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about posttraumatic stress disorder, a rationale for trauma-focused exposure therapy, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797382|NCT01409707|P1|Participant Flow|Healthy Lifestyles Sessions|Healthy lifestyles sessions is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
797383|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797471|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
797522|NCT01408719|B15|Baseline|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
797384|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797385|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
797386|NCT01409707|O3|Outcome|Motivational Enhancement + Trauma-focused Exposure Therapy|One 90 min. motivational enhancement therapy session was provided prior to beginning trauma focused therapy. EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797387|NCT01409707|O2|Outcome|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797388|NCT01409707|O1|Outcome|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
797389|NCT01409707|E2|Reported Event|Trauma-focused Exposure Therapy|EXP is a well-described cognitive-behavioral therapy that utilizes imaginal and in vivo exposure techniques to reduce the symptoms of PTSD. In addition to imaginal and iv vivo exposure techniques, in the current study patients were provided psychoeducation about PTSD, a rationale for EXP, and were taught breathing retraining as a method to manage arousal associated with PTSD. Nine to 12 50-60 minutes sessions were provided.
797390|NCT01409707|E1|Reported Event|Healthy Lifestyles Sessions|HLS is a structured 9-12 session intervention that provides education about a variety of health-related topics. Each therapy session was 50-60 minutes long. Sessions included the provision of information, discussing participants' understanding of information, and answering questions about the information provided.
797391|NCT01409564|B3|Baseline|Total|Total of all reporting groups
797392|NCT01409564|B2|Baseline|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
797393|NCT01409564|B1|Baseline|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
797394|NCT01409564|P2|Participant Flow|Placebo|Placebo group includes dementia patients receiving donepezil with placebo. All the patients were randomly assigned as placebo group and received 10 mg of Donepezil along with the same dose of sugar pill as normal cilostazol. All the clinical assessments and medications were doubly blinded. All the medications were orally administered.
797395|NCT01409564|P1|Participant Flow|Cilostazol|Cilostazol group includes dementia patients receiving donepezil with cilostazol augmentation. All the randomly assigned AD patients in cilostazol group received 10 mg of Donepezil along with 200 mg of cilostazol per a day, doubly blinded. All the medications were orally administered. For the initial two weeks, patients only received 100 mg of cilstazol per a day to minimize the instabilities. Afterwards, for 22 weeks, patients received 200 mg of cilostazol.
797396|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
797397|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
797398|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
797399|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
797400|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
797401|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
797402|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
797403|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
797404|NCT01409564|O2|Outcome|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
797405|NCT01409564|O1|Outcome|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
797406|NCT01409564|O4|Outcome|Placebo, 24-week|Placebo group means dementia patients group receiving donepezil with placebo after 24 weeks.
797407|NCT01409564|O3|Outcome|Placebo, Baseline|Placebo group means dementia patients group receiving donepezil with placebo at the baseline.
797408|NCT01409564|O2|Outcome|Cilostazol, 24-week|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation after 24 weeks.
797409|NCT01409564|O1|Outcome|Cilostazol, Baseline|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation at the baseline.
797410|NCT01409564|E2|Reported Event|Placebo|Placebo group means dementia patients group receiving donepezil with placebo.
797411|NCT01409564|E1|Reported Event|Cilostazol|Cilostazol group means dementia patients group receiving donepezil with cilostazol augmentation.
797412|NCT01409434|B1|Baseline|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797473|NCT01409096|E2|Reported Event|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
797413|NCT01409434|P1|Participant Flow|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797414|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797415|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797416|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797417|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797418|NCT01409434|O1|Outcome|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797419|NCT01409434|E1|Reported Event|Follow-Up Arm|"All patients are recruited for inclusion in the Follow-Up Arm, which is the sole arm of the study. The Follow-Up Arm includes a one time study visit in which study interventions are performed.~Oral Glucose Tolerance Test: Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline)."
797420|NCT01409382|B3|Baseline|Total|Total of all reporting groups
797421|NCT01409382|B2|Baseline|Standard Follow-up|Prenatal care will proceed according to the routine
797422|NCT01409382|B1|Baseline|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
797423|NCT01409382|P2|Participant Flow|Standard Follow-up|Prenatal care will proceed according to the routine. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
797424|NCT01409382|P1|Participant Flow|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet. Patients assigned to the intervention protocol will be instructed to walk briskly for at least 40 minutes seven days a week, to avoid high-carbohydrate meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Antidepressants will be not discontinued, but patients on paroxetine and sertraline will be switched to fluoxetine.
797425|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
797426|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
797427|NCT01409382|O2|Outcome|Neonates Born to Controls|Neonates with hypoglycemia detected 1, 2 or 4 hours after birth
797428|NCT01409382|O1|Outcome|Neonates Born to Mothers Assigned to Protocol Walking+Diet|Neonates with hypoglycemia (blood glucose levels ≤ 40 mg/dL) at 1, 2 or 4 hours after birth
797429|NCT01409382|O2|Outcome|Standard Follow-up|Prenatal care will proceed according to the routine.
797430|NCT01409382|O1|Outcome|Lifestyle Counseling|Daily brisk walking plus a carbohydrate-restricted diet
797431|NCT01409382|E4|Reported Event|Lifestyle Counseling (Babies)|Exercise plus a carbohydrate-controlled diet.
797432|NCT01409382|E3|Reported Event|Standard Follow-up (Babies)|Prenatal care will proceed according to the routine.
797433|NCT01409382|E2|Reported Event|Lifestyle Counseling (Mothers)|Exercise plus a carbohydrate-controlled diet.
797434|NCT01409382|E1|Reported Event|Standard Follow-up (Mothers)|Prenatal care will proceed according to the routine.
797435|NCT01409291|B3|Baseline|Total|Total of all reporting groups
797436|NCT01409291|B2|Baseline|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
797437|NCT01409291|B1|Baseline|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
797438|NCT01409291|P2|Participant Flow|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
797439|NCT01409291|P1|Participant Flow|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
797440|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
797441|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
797442|NCT01409291|O2|Outcome|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
797443|NCT01409291|O1|Outcome|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
797444|NCT01409291|E2|Reported Event|Children|Children between ages 3 and 18 years whose mothers were participating in the Financial Success Program.
797445|NCT01409291|E1|Reported Event|Mothers|All participants of the Financial Success Program were approached for the study. This was a single arm descriptive study.
797446|NCT01409239|B3|Baseline|Total|Total of all reporting groups
797472|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
798044|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
797447|NCT01409239|B2|Baseline|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
797448|NCT01409239|B1|Baseline|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
797449|NCT01409239|P2|Participant Flow|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
797450|NCT01409239|P1|Participant Flow|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
797451|NCT01409239|O2|Outcome|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital's universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
797452|NCT01409239|O1|Outcome|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
797453|NCT01409239|E2|Reported Event|Intravenous Insulin|IV insulin was started at 0500 hours the morning following consent. Patients continued to receive prandial and correction insulin until the IV insulin was started, after which only the prandial component was continued. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which was adapted from a published protocol and has a target glucose of 6.1-8.3 mmol/l. All floor nurses are trained in its use. Patients were transitioned from the infusion at 1700 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
797454|NCT01409239|E1|Reported Event|Subcutaneous Insulin|Among patients receiving subcutaneous insulin, basal and prandial insulin were administered in approximately equal total daily doses with correction dosing. Daily adjustments were based upon 10-20% of the total daily dose.
797455|NCT01409213|B1|Baseline|All Enrolled Participants|Full analysis set (FAS) consisted of 1522 participants; one participant was excluded from the FAS due to missing data at baseline.
797456|NCT01409213|P1|Participant Flow|All Enrolled Participants|
797457|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
797458|NCT01409213|O1|Outcome|All Enrolled Participants|All enrolled participants with available data.
797459|NCT01409213|E1|Reported Event|All Enrolled Participants|
797460|NCT01409096|B3|Baseline|Total|Total of all reporting groups
797461|NCT01409096|B2|Baseline|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
797462|NCT01409096|B1|Baseline|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
797463|NCT01409096|P2|Participant Flow|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
797464|NCT01409096|P1|Participant Flow|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
797465|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
797466|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
797467|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
797468|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
797469|NCT01409096|O2|Outcome|Placebo|"The arm will be given placebo that matches the Pregnenolone at the same frequency as the Pregnenolone for 12 weeks.~Placebo: Inactive ingredient matching the active medication in appearance."
797470|NCT01409096|O1|Outcome|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
797474|NCT01409096|E1|Reported Event|Pregnenolone|"This arm will be given 50mg Pregnenolone twice per day for 2 weeks, then 150mg Pregnenolone twice per day for 2 weeks, then 250mg Pregnenolone twice per day for 8 weeks.~Pregnenolone: Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system."
797475|NCT01408992|B1|Baseline|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. A total of 551 subjects were required to obtain an 80% sensitivity rate for the original test, at a 95% confidence level, with 80% power, and a 7% margin of error. Considering 22.7% as the estimated prevalence of hearing loss [Prasansuk, 2000] and a 10% drop out rate, the total number of subjects needed was 606. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older
797476|NCT01408992|P1|Participant Flow|Community People|The Phu Wieng district in Khon Kaen Province was chosen as a representative rural community in Thailand. This district comprises 114 villages and has a population of 24,201 inhabitants. Of these, 13,001 inhabitants lived in municipal areas, whereas the rest lived in non-municipal areas. The subjects were recruited from different target villages. The villages had been divided according to their municipality. The target villages were simply randomly selected from a list of villages that have more than 300 adults in their populations. One village was from a municipal area and the other village was from a non-municipal area. All of the people in the target villages, who were older than 18 years, could read or understand the Thai language, and wanted to participate, were recruited. Those who had aphasia, severe mental disability, or other conditions that precluded audiometry were excluded.
797477|NCT01408992|O1|Outcome|Hearing Loss|The severity of hearing loss was defined by the pure tone average air-conduction threshold at the speech frequencies of the better hearing ears, according to the ASHA criteria. Normal hearing means PTA of less than or equal 25 dB. Mild hearing loss means PTA of 26-40 dB. Moderate hearing loss means PTA of 41-55 dB. Moderately severe hearing loss means PTA of 56-74 dB. Severe hearing loss means PTA of 75-90 dB. Profound hearing loss means PTA > 90 dB.
797478|NCT01408992|O1|Outcome|FMHT|"FMHT Score is the sum of value of the answers for each question. If the subject answers never, it will be scored as 0, occasionally will be 1, half the time will be 2, and almost always will be 3."
797479|NCT01408992|O7|Outcome|Mixed Hearing Loss|Air and bone conduction threshold are more than 25 dB with air-bone gap
797480|NCT01408992|O6|Outcome|Sensorineural Hearing Loss|Air and bone conduction thresholds are more than 25 dB
797481|NCT01408992|O5|Outcome|Conductive Hearing Loss|Air-bone gap and bone conduction thresholds are lower than 25 dB
797482|NCT01408992|O4|Outcome|Chronic Otitis Media|Tympanic membrane perforation with or without ear discharge
797483|NCT01408992|O3|Outcome|Otitis Media With Effusion|Fluid in middle ear, whether serous, mucoid, mucous, or pus
797484|NCT01408992|O2|Outcome|Ear Wax|Impacted cerumen
797485|NCT01408992|O1|Outcome|Normal Ears and Hearing|Normal ear examination and normal hearing
797486|NCT01408992|E1|Reported Event|Community People|All people who live in the Phu Wieng district in Khon Kaen Province was chosen as a representative of community people in Thailand.
797487|NCT01408888|B1|Baseline|Entire Study Population|Participants who received at least one dose of study drug (LY2189265 or Sitagliptin).
797488|NCT01408888|P2|Participant Flow|Sitagliptin + LY2189265, LY2189265|"First Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~Second Intervention Period: A single 1.5-mg SC injection of LY2189265 on Day 1 (Treatment 1).~There was a washout of at least 21 days between treatments."
797489|NCT01408888|P1|Participant Flow|LY2189265, Sitagliptin + LY2189265|"First Intervention Period: A single 1.5-milligram (mg) subcutaneous (SC) injection of LY2189265 on Day 1 (Treatment 1).~Second Intervention Period: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2).~There was a washout of at least 21 days between treatments."
797490|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
797491|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
797492|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
797493|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
797514|NCT01408862|O1|Outcome|Controls|Flow cytometry studies In order to test the presence of GLP1 and GIP receptors on normal platelet membrane, indirect immunodetection was carried out in platelet samples from 20 normal donors.
797515|NCT01408862|E1|Reported Event|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
797494|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
797495|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5 mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
797496|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 12)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 12 of Treatment 2.
797497|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 5)|Sitagliptin + LY2189265: A single, 1.5-mg dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 5 of Treatment 2.
797498|NCT01408888|O1|Outcome|1.5 mg LY2189265 (Day 1)|Sitagliptin + LY2189265: A single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously (Treatment 1). There was a washout period of at least 21 days before crossing over and receiving 100 mg of sitagliptin administered orally, once daily for 18 days in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 (Treatment 2). Measure taken on Day 1 of Treatment 1.
797499|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
797500|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
797501|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
797502|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
797503|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg of LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
797504|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
797505|NCT01408888|O3|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 13)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 13.
797506|NCT01408888|O2|Outcome|100 mg Sitagliptin + 1.5 mg LY2189265 (Day 6)|Sitagliptin + LY2189265: 100 mg of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single SC injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 6.
797507|NCT01408888|O1|Outcome|100 mg Sitagliptin (Day 4)|Sitagliptin + LY2189265: 100 milligrams (mg) of sitagliptin, administered orally, once daily on Day 1 to Day 18 with single subcutaneous (SC) injections of 1.5 mg LY2189265 immediately prior to the sitagliptin dose on Day 5 and Day 12 (Treatment 2). Measure taken at Day 4.
797508|NCT01408888|E3|Reported Event|Sitagliptin + LY2189265|"Sitagliptin + LY2189265: 100-mg dose of sitagliptin administered orally, once daily from Day 5 to Day 18 of Treatment 2 in combination with two separate single 1.5-mg doses of LY2189265 administered subcutaneously, immediately prior to the sitagliptin doses on Day 5 and Day 12 of Treatment 2.~Time Frame: Day 5 to end of Treatment 2"
797509|NCT01408888|E2|Reported Event|Sitagliptin|"Sitagliptin: 100-mg dose of sitagliptin, administered orally, once daily before the LY2189265 dose on Day 1 to Day 5 of Treatment 2.~Time Frame: Day 1 to Day 5 of Treatment 2"
797510|NCT01408888|E1|Reported Event|LY2189265|"LY2189265: a single, 1.5-milligram (mg) dose of LY2189265 administered subcutaneously on Day 1 of Treatment 1~Time frame: Treatment 1"
797511|NCT01408862|B1|Baseline|Controls|Platelets from healthy human subjects who were not taken any medication in the previous 10 days were studied. Blood samples (30 ml) were drawn with i) ACD-C (9:1, v/v) (7 mmol/L citric acid, 93 mmol/L citrate, 139 mmol/L dextrose, pH 6.4) for gene expression and western blot studies; ii) with 1% EDTA for flow cytometry and iii) with 3.8% sodium citrate for functional studies. Blood samples were centrifuged at 150 g for 10 min to obtain platelet-rich plasma (PRP).
797512|NCT01408862|P1|Participant Flow|Controls|"20 healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
797513|NCT01408862|O1|Outcome|Controls|"Healthy volunteers were asked to donor a 10-80 ml blood through a venous puncture~venous puncture: Blood for in vitro studies were drawn"
797516|NCT01408719|B21|Baseline|Total|Total of all reporting groups
797517|NCT01408719|B20|Baseline|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
797523|NCT01408719|B14|Baseline|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
797524|NCT01408719|B13|Baseline|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
797525|NCT01408719|B12|Baseline|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
797526|NCT01408719|B11|Baseline|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
797527|NCT01408719|B10|Baseline|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
797528|NCT01408719|B9|Baseline|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
797529|NCT01408719|B8|Baseline|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
797530|NCT01408719|B7|Baseline|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
797531|NCT01408719|B6|Baseline|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
797532|NCT01408719|B5|Baseline|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
797533|NCT01408719|B4|Baseline|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
797534|NCT01408719|B3|Baseline|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
797535|NCT01408719|B2|Baseline|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
797536|NCT01408719|B1|Baseline|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
797537|NCT01408719|P20|Participant Flow|Sequence 20|3g HMW, followed by 5g LMW, followed by control, followed by 3g LMW
797538|NCT01408719|P19|Participant Flow|Sequence 19|Control, followed by 3g HMW, followed by 3g LMW, followed by 5g LMW
797539|NCT01408719|P18|Participant Flow|Sequence 18|5g LMW, followed by 3g HMW, followed by control, followed by 3g LMW
797540|NCT01408719|P17|Participant Flow|Sequence 17|3g HMW, followed by 3g LMW, followed 5g LMW, followed by control
797541|NCT01408719|P16|Participant Flow|Sequence 16|3g HMW, followed by 5g LMW, followed 3g LMW, followed by control
797542|NCT01408719|P15|Participant Flow|Sequence 15|3g LMW, followed by 5g LMW, followed by control, followed by 3g HMW
797543|NCT01408719|P14|Participant Flow|Sequence 14|3g LMW, followed by 5g LMW, followed by 3g HMW, followed by control
797544|NCT01408719|P13|Participant Flow|Sequence 13|3g HMW, followed by control, followed by 3g LMW, followed by 5g LMW
797545|NCT01408719|P12|Participant Flow|Sequence 12|5g LMW, followed by control, followed by 3g LMW, followed by 3g HMW
797546|NCT01408719|P11|Participant Flow|Sequence 11|3g HMW, followed by control, followed by 5g LMW, followed by 3g LMW
797547|NCT01408719|P10|Participant Flow|Sequence 10|Control, followed by 3g LMW, followed by 5g LMW, followed by 3g HMW
797548|NCT01408719|P9|Participant Flow|Sequence 9|Control, followed by 5g HMW, followed by 3g LMW, followed by 3g HMW
797549|NCT01408719|P8|Participant Flow|Sequence 8|3g LMW, followed by 3g HMW, followed by control, followed by 5g HMW
797550|NCT01408719|P7|Participant Flow|Sequence 7|5g LMW, followed by 3g LMW, followed control, followed by 3g HMW
797551|NCT01408719|P6|Participant Flow|Sequence 6|control, followed by 5g LMW, followed by 3g HMW, followed by 3g LMW
797552|NCT01408719|P5|Participant Flow|Sequence 5|3g HMW, followed by 3g LMW, followed by control, followed by 5g LMW
797553|NCT01408719|P4|Participant Flow|Sequence 4|5g LMW, followed by 3g LMW, followed by 3g HMW, followed by control
797554|NCT01408719|P3|Participant Flow|Sequence 3|3g LMW, followed by 3g HMW, followed by 5g LMW, followed by control
797555|NCT01408719|P2|Participant Flow|Sequence 2|Control, followed by 3g HMW, followed by 5g LMW, followed by 3g LMW
797556|NCT01408719|P1|Participant Flow|Sequence 1|3g LMW followed by control, followed by 3g HMW, followed by 5g LMW
797557|NCT01408719|O4|Outcome|Control|"control diet containing negligible amount of beta glucan~3g HMW beta-glucan: 3 grams of high molecular weight beta-glucan"
797558|NCT01408719|O3|Outcome|3g LMW Beta Glucan|"3 grams of low molecular weight beta-glucan diet for 35 days~5g LMW beta-glucan: 5 grams beta-glucan"
797559|NCT01408719|O2|Outcome|3g HMW Beta Glucan|"3 gram high molecular weight barley beta-glucan diet for 35 days~3g LMW beta-glucan: 3grams beta-glucan"
797560|NCT01408719|O1|Outcome|5g LMW Beta Glucan|"5 gram low molecular weight barley beta-glucan diet for 35 days~Control: Minimal beta-glucan"
797561|NCT01408719|E4|Reported Event|5g LMW Beta-glucan|5 grams low molecular weight barley beta-glucan
797562|NCT01408719|E3|Reported Event|3g LMW Beta-glucan|3 grams low molecular weight barley beta-glucan
797563|NCT01408719|E2|Reported Event|3g HMW Beta-glucan|3 grams high molecular weight barley beta-glucan
797564|NCT01408719|E1|Reported Event|Control|Minimal barley and minimal beta-glucan
797565|NCT01408628|B1|Baseline|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
797566|NCT01408628|P1|Participant Flow|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
797567|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
797598|NCT01408329|O2|Outcome|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6097m
797599|NCT01408329|O1|Outcome|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
797600|NCT01408329|E2|Reported Event|Cyclic Hypoxic Group|Rapidly fluctuating simulated altitude up to 6097 meters
797568|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
797569|NCT01408628|O1|Outcome|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of ≤ 7.0% using an established treat-to-target algorithm.
797570|NCT01408628|E1|Reported Event|Internet Insulin Education|Internet Insulin Education: Offer and assess the safety and effectiveness of a synchronous (“live”) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm.
797571|NCT01408537|B1|Baseline|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
797572|NCT01408537|P1|Participant Flow|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
797573|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
797574|NCT01408537|O8|Outcome|SAEs Entire the Study|SAEs which occured entire the study period were recorded.
797575|NCT01408537|O7|Outcome|Unsolicited AEs After Each Vaccination|unsolicited AEs after each vaccinations (3 doses). Episode of unsolicited AEs (excluded SAEs) were collected up to 28 days after each vaccination
797576|NCT01408537|O6|Outcome|Urticaria After Vaccination|Urticaria after each vaccinations (3 doses). Episode of Urticaria was collected up to 28 days after each vaccination.
797577|NCT01408537|O5|Outcome|Vomiting After Vaccination|Vomiting after each vaccinations (3 doses). Episode of vomiting was collected up to 28 days after each vaccination.
797578|NCT01408537|O4|Outcome|Poor Appetite After Vaccination|Poor appetite after each vaccinations (3 doses). Episode of poor appetite was collected up to 28 days after each vaccination.
797579|NCT01408537|O3|Outcome|Chills After Vaccination|Chills after each vaccinations (3 doses). Episode of chills was collected up to 28 days after each vaccination.
797580|NCT01408537|O2|Outcome|Local AE JEVAC After Vaccination|"Local Adverse event (tenderness, redness, ecchymosis, hematoma and swelling) after each vaccinations the first vaccination was on day of enrollment, the second dose was Day7 (+21day))~, Booster vaccine was on 1 year(+30days). Local AEs were collected up to 28 days after each vaccination."
797581|NCT01408537|O1|Outcome|Fever After Vaccination|Fever (Temp > =37.5 Axillary )after each vaccinations (3 doses). Episode of fever was collected up to 28 days after each vaccination.
797582|NCT01408537|O3|Outcome|GMT of NT Titer After Booster Vaccine|GMT of NT of subject at 28 days after booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
797583|NCT01408537|O2|Outcome|GMT of NT Before Booster Vaccine|GMT of NT of subject at 1 year before booster vaccination. Exclude NT titer >=10 before first vaccination and subjects received JE vaccine outside the study.
797584|NCT01408537|O1|Outcome|GMT of NT on 28days After Vaccination|GMT of NT titer of subjects on 28 days after vaccination (excluded the subject who had NT titer > =10 before first vaccination).
797585|NCT01408537|O1|Outcome|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
797586|NCT01408537|E1|Reported Event|JEVAC|JEVAC : Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
797587|NCT01408485|B1|Baseline|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
797588|NCT01408485|P1|Participant Flow|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
797589|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
797590|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
797591|NCT01408485|O1|Outcome|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
797592|NCT01408485|E1|Reported Event|Treatment Arm|"Therapy™ Cool Flex™ Irrigated Ablation System: The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter~IBI 1500T9 V1.43 RF Generator"
797593|NCT01408329|B3|Baseline|Total|Total of all reporting groups
797594|NCT01408329|B2|Baseline|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
797595|NCT01408329|B1|Baseline|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
797596|NCT01408329|P2|Participant Flow|Cyclic Hypoxic Group|Rapidly fluctuating pressures simulating altitude up to 6096 meters
797597|NCT01408329|P1|Participant Flow|Sham Group|Slowly fluctuating pressures simulating altitude up to 607 meters
797604|NCT01408303|B2|Baseline|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
797605|NCT01408303|B1|Baseline|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
797606|NCT01408303|P3|Participant Flow|Olive Oil + Statin|"olive oil, 1 g capsule~olive oil: 4 x 1 g capsule daily for 6 weeks~prescribed statin"
797607|NCT01408303|P2|Participant Flow|Epanova, 4 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids: omega-3 carboxylic acids 4 x 1 g capsule daily for 6 weeks~prescribed statin"
797608|NCT01408303|P1|Participant Flow|Epanova, 2 g + Statin|"omega-3 carboxylic acids, 1 g capsule~omega-3 carboxylic acids + olive oil: omega-3 carboxylic acids 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks~prescribe statin"
797609|NCT01408303|O3|Outcome|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
797610|NCT01408303|O2|Outcome|Epanova 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
797611|NCT01408303|O1|Outcome|Epanova 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo: omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
797612|NCT01408303|E3|Reported Event|Placebo|"placebo, 1 g capsule~placebo : 4 x 1 g capsule daily for 6 weeks"
797613|NCT01408303|E2|Reported Event|Epanova, 4 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids: omega-3-carboxylic acids 4 x 1 g capsule daily for 6 weeks
797614|NCT01408303|E1|Reported Event|Epanova, 2 g|omega-3-carboxylic acids, 1 g capsule omega-3-carboxylic acids + placebo : omega-3-carboxylic acids 2 x 1 g capsule + placebo 2 x 1 g capsule daily for 6 weeks
797615|NCT01408277|B3|Baseline|Total|Total of all reporting groups
797616|NCT01408277|B2|Baseline|Control|Standard Care
797617|NCT01408277|B1|Baseline|Santyl|Collagenase (SANTYL®) Ointment
797618|NCT01408277|P2|Participant Flow|Control|Standard Care
797619|NCT01408277|P1|Participant Flow|Santyl|Collagenase (SANTYL®) Ointment
797620|NCT01408277|O2|Outcome|Control|"Control = Standard Care~Standard Care is defined as the standard wound care protocol for chronic wounds used by each Investigator, in their clinic (e.g., wet-to-dry, compression, sharp debridement, etc.)."
797621|NCT01408277|O1|Outcome|Santyl®|Collagenase (Santyl®) Ointment
797622|NCT01408277|E2|Reported Event|Control|Standard Care
797623|NCT01408277|E1|Reported Event|Santyl|Collagense (Santyl®) Ointment
797624|NCT01407354|B1|Baseline|All Study Participants|Baseline data reflects all participants who received both aquatic exercise and lokomat training during the study.
797625|NCT01407354|P2|Participant Flow|Aquatic Therapy First Then Lokomat Intervention|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session, participants received lokomat intervention after aquatic exercise"
797626|NCT01407354|P1|Participant Flow|Lokomat First Then Aquatic Exercise|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session, participants received aquatic exercise after lokomat"
797627|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
797628|NCT01407354|O1|Outcome|Lokomat|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session,"
797629|NCT01407354|O2|Outcome|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
797630|NCT01407354|O1|Outcome|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
797631|NCT01407354|E2|Reported Event|Aquatic Therapy|"Aquatic exercise therapy~Aquatic exercise therapy: Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session"
797632|NCT01407354|E1|Reported Event|Lokomat Training|"Lokomat robotic assisted treadmill training Lokomat Treadmill Training~Lokomat treadmill training: Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session"
797633|NCT01407276|B9|Baseline|Total|Total of all reporting groups
797634|NCT01407276|B8|Baseline|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
797635|NCT01407276|B7|Baseline|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
797636|NCT01407276|B6|Baseline|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797637|NCT01407276|B5|Baseline|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797638|NCT01407276|B4|Baseline|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797639|NCT01407276|B3|Baseline|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797640|NCT01407276|B2|Baseline|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797641|NCT01407276|B1|Baseline|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797642|NCT01407276|P8|Participant Flow|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G.
798045|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
797643|NCT01407276|P7|Participant Flow|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
797644|NCT01407276|P6|Participant Flow|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797645|NCT01407276|P5|Participant Flow|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797646|NCT01407276|P4|Participant Flow|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797647|NCT01407276|P3|Participant Flow|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797648|NCT01407276|P2|Participant Flow|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797649|NCT01407276|P1|Participant Flow|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797650|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797651|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
797652|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797653|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797654|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797655|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797656|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797657|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797658|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797659|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Periods 1 and 2|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G.
797660|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797661|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797662|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797663|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797664|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797665|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797666|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
797667|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797668|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
797669|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
797670|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797671|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797672|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797673|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797674|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797675|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797676|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797776|NCT01407575|P1|Participant Flow|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797677|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797678|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797679|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
797680|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797681|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797682|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797683|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797684|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797685|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797686|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797687|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797688|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797689|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797690|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797691|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797692|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797693|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797694|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797695|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797696|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797697|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797698|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797699|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797700|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797701|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797702|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797703|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797704|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
797705|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797706|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
797707|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
797739|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797708|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797777|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
797709|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797710|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797711|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797712|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797713|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797714|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from the study was not included.
797715|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797716|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
797717|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
797718|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797719|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797720|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797721|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797722|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797723|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797724|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797725|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797726|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797727|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
797728|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797729|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797730|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797731|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797732|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797733|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797734|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797735|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797736|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797737|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
797738|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797773|NCT01407575|B2|Baseline|Placebo|Placebo: matched placebo
797740|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797741|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797742|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797743|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797744|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797745|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797746|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797747|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD.
797748|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797749|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797750|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797751|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797752|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797753|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797754|NCT01407276|O10|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 2|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
797755|NCT01407276|O9|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 2|Participants with ESRD requiring HD were enrolled in Panel G. In Period 2, participants received MK-3102 3 mg 2 hours prior to HD.
797756|NCT01407276|O8|Outcome|Part 2: Control to Match Panel G (Panel H) - Period 1|Participants were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from the participant that withdrew from study was not included.
797757|NCT01407276|O7|Outcome|Part 2: ESRD Requiring HD (Panel G) - Period 1|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD) were enrolled in Panel G. In Period 1, participants received MK-3102 3 mg immediately after HD. One participant did not have an estimable parameter.
797758|NCT01407276|O6|Outcome|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797759|NCT01407276|O5|Outcome|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797760|NCT01407276|O4|Outcome|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797761|NCT01407276|O3|Outcome|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797762|NCT01407276|O2|Outcome|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797763|NCT01407276|O1|Outcome|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797764|NCT01407276|E8|Reported Event|Part 2: Control to Match Panel G (Panel H)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel G. Data from one participant who withdrew from study and data from the replacement participant are both included.
797765|NCT01407276|E7|Reported Event|Part 2: ESRD Requiring HD (Panel G)|Participants with end-stage renal disease (ESRD) requiring hemodialysis (HD)
797766|NCT01407276|E6|Reported Event|Part 1: Control to Match Panel E (Panel F)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel E.
797767|NCT01407276|E5|Reported Event|Part 1: Severe Renal Impairment (Panel E)|Participants with eGFR <30 mL/min/1.73 m² but not on dialysis were enrolled in the Severe Renal Impairment group.
797768|NCT01407276|E4|Reported Event|Part 1: Control to Match Panel C (Panel D)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel C.
797769|NCT01407276|E3|Reported Event|Part 1: Moderate Renal Impairment (Panel C)|Participants with eGFR ≥30 - <60 mL/min/1.73 m² were enrolled in the Moderate Renal Impairment group.
797770|NCT01407276|E2|Reported Event|Part 1: Control to Match Panel A (Panel B)|Participants with eGFR >/= 80 mL/min/1.73 m² were matched by age, gender, race, and body mass index (BMI) to participants in Panel A.
797771|NCT01407276|E1|Reported Event|Part 1: Mild Renal Impairment (Panel A)|Participants with estimated glomerular filtration rate (eGFR) ≥60 - <80 mL/min/1.73 m² were enrolled in the Mild Renal Impairment group.
797772|NCT01407575|B3|Baseline|Total|Total of all reporting groups
797774|NCT01407575|B1|Baseline|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797775|NCT01407575|P2|Participant Flow|Placebo|Placebo: matched placebo
797778|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797779|NCT01407575|O2|Outcome|Placebo|"matching placebo- sublingual- over the course of 8 weeks~Placebo: matched placebo"
797780|NCT01407575|O1|Outcome|Buprenorphine|"0.2 to 1.6mg of buprenorphine sublingual over the course of 8 weeks~Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)"
797781|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
797782|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797783|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
797784|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797785|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
797786|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797787|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
797788|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797789|NCT01407575|O2|Outcome|Placebo|Placebo: matched placebo
797790|NCT01407575|O1|Outcome|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797791|NCT01407575|E2|Reported Event|Placebo|Placebo: matched placebo
797792|NCT01407575|E1|Reported Event|Buprenorphine|Buprenorphine: low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
797793|NCT01407523|B1|Baseline|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797794|NCT01407523|P1|Participant Flow|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797795|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797796|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797797|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797798|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797799|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797800|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797801|NCT01407523|O1|Outcome|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797802|NCT01407523|E1|Reported Event|Levetiracetam|"Twice daily intravenous (IV) infusion of Levetiracetam solution equivalent (mg-for-mg) to oral dose of Levetiracetam.~Levetiracetam :~Formulation: concentrate for solution for infusion~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day~Frequency: twice daily"
797803|NCT01407068|B1|Baseline|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
797804|NCT01407068|P1|Participant Flow|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
797805|NCT01407068|O2|Outcome|AA4500 PIP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the interphalangeal (PIP) joint cord"
797806|NCT01407068|O1|Outcome|AA4500 MP|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand in the metacarpophalangeal (MP) joint cord"
797807|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
797808|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
797809|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
797810|NCT01407068|O1|Outcome|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
797811|NCT01407068|E1|Reported Event|AA4500|"AA4500 collagenase clostridium histolyticum~AA4500 collagenase clostridium histolyticum: 2 concurrent injections (0.58 mg) into 2 cords on the same hand"
797812|NCT01406990|B1|Baseline|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
797813|NCT01406990|P1|Participant Flow|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
797814|NCT01406990|O1|Outcome|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
797815|NCT01406990|E1|Reported Event|Aspirin 81 mg|Women with CAD taking 81 mg aspirin.
797816|NCT01406938|B3|Baseline|Total|Total of all reporting groups
797817|NCT01406938|B2|Baseline|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797818|NCT01406938|B1|Baseline|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797819|NCT01406938|P6|Participant Flow|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797820|NCT01406938|P5|Participant Flow|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797821|NCT01406938|P4|Participant Flow|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797822|NCT01406938|P3|Participant Flow|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797823|NCT01406938|P2|Participant Flow|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797824|NCT01406938|P1|Participant Flow|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797825|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797826|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797827|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797828|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797829|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797830|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797831|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797832|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797833|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797834|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797835|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797836|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797837|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797838|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797839|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797840|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797841|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797842|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797843|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797844|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797845|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797846|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797847|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797848|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797849|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797850|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797851|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797852|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797853|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797854|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797855|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797856|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797857|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797858|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797859|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797860|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797861|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797862|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797864|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797865|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797866|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797867|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797868|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797869|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797870|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797871|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797872|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797873|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797874|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797875|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797876|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797877|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797878|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797879|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797880|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797881|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797882|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797883|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797884|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797885|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797886|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797887|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797888|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797889|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797890|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797891|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797892|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797893|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797894|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797895|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797896|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797897|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797898|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797899|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797900|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797901|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797902|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797903|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797904|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797905|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797906|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797907|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797908|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797909|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797910|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797911|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797912|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797914|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797915|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797916|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797917|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797918|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797919|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797920|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797921|NCT01406938|O6|Outcome|AIN457 300 mg- SoR|2 s.c. secukinumab 150 mg injections
797922|NCT01406938|O5|Outcome|AIN457 150 mg- Start of Relapse (SoR)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection
797923|NCT01406938|O4|Outcome|AIN457 300 mg FI|2 s.c. secukinumab 150 mg injections
797924|NCT01406938|O3|Outcome|AIN457 150 mg - Fixed Interval (FI)|1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection
797925|NCT01406938|O2|Outcome|AIN457 300 mg - IPO|secukinumab- 2 x 150mg injections per dose
797926|NCT01406938|O1|Outcome|AIN457150 mg- Induction Period Only(IPO)|secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO)
797927|NCT01406938|E12|Reported Event|FOLLOW UP-AIN457 300 mg SoR|FOLLOW UP-AIN457 300 mg SoR
797928|NCT01406938|E11|Reported Event|FOLLOW UP-AIN457 150 mg SoR|FOLLOW UP-AIN457 150 mg SoR
797929|NCT01406938|E10|Reported Event|FOLLOW UP-AIN457 300 mg|FOLLOW UP-AIN457 300 mg
797930|NCT01406938|E9|Reported Event|FOLLOW UP-AIN457 150 mg|FOLLOW UP-AIN457 150 mg
797931|NCT01406938|E8|Reported Event|FOLLOW UP-AIN457 300mg IPO|FOLLOW UP-AIN457 300mg IPO
797932|NCT01406938|E7|Reported Event|FOLLOW UP-AIN457 150mg IPO|FOLLOW UP-AIN457 150mg IPO
797933|NCT01406938|E6|Reported Event|ENTIRE-AIN457 300 mg SoR|ENTIRE-AIN457 300 mg SoR
797934|NCT01406938|E5|Reported Event|ENTIRE-AIN457 150 mg SoR|ENTIRE-AIN457 150 mg SoR
797935|NCT01406938|E4|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
797936|NCT01406938|E3|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
797937|NCT01406938|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
797938|NCT01406938|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
797939|NCT01406795|B1|Baseline|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797940|NCT01406795|P1|Participant Flow|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797941|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797942|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797943|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797944|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797945|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797946|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797947|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797948|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
798003|NCT01405937|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
797949|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
798006|NCT01405937|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
797950|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797951|NCT01406795|O1|Outcome|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797952|NCT01406795|E1|Reported Event|Venous Stent Arm|"The study is a single treatment arm study and the venous stent will be placed in all eligible participants.~Gore Viabahn Heparin Coated Stent: For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open."
797953|NCT01406574|B1|Baseline|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797954|NCT01406574|P4|Participant Flow|OPB-31121: 400mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
797955|NCT01406574|P3|Participant Flow|OPB-31121: 200mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
797956|NCT01406574|P2|Participant Flow|OPB-31121: 100mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
797957|NCT01406574|P1|Participant Flow|OPB-31121: 50mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797958|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797959|NCT01406574|O4|Outcome|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
797960|NCT01406574|O3|Outcome|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
797961|NCT01406574|O2|Outcome|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle
797962|NCT01406574|O1|Outcome|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797963|NCT01406574|O1|Outcome|OPB-31121|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797964|NCT01406574|E4|Reported Event|OPB-31121: 400 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797965|NCT01406574|E3|Reported Event|OPB-31121: 200 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797966|NCT01406574|E2|Reported Event|OPB-31121: 100 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797967|NCT01406574|E1|Reported Event|OPB-31121: 50 mg/Day|OPB-31121: 50, 100, 200 and 400 mg/day oral once daily (QD) in a 4 week cycle.
797968|NCT01406015|B3|Baseline|Total|Total of all reporting groups
797969|NCT01406015|B2|Baseline|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797970|NCT01406015|B1|Baseline|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797971|NCT01406015|P2|Participant Flow|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797972|NCT01406015|P1|Participant Flow|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797973|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797974|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797975|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797976|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797977|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797978|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797979|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797980|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797981|NCT01406015|O2|Outcome|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797982|NCT01406015|O1|Outcome|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797983|NCT01406015|E2|Reported Event|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
797984|NCT01406015|E1|Reported Event|Spironolactone|Spironolactone 50 mg once daily for 6 weeks.
797985|NCT01405950|B3|Baseline|Total|Total of all reporting groups
797986|NCT01405950|B2|Baseline|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
797987|NCT01405950|B1|Baseline|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
797988|NCT01405950|P4|Participant Flow|Dose Level 4|Zanaflex Capsules : 0.1 mg/kg
797989|NCT01405950|P3|Participant Flow|Dose Level 3|Zanaflex Capsules : 0.075 mg/kg
797990|NCT01405950|P2|Participant Flow|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
797991|NCT01405950|P1|Participant Flow|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
797992|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
797993|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
797994|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
797995|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
797996|NCT01405950|O4|Outcome|Dose Level 4|Zanaflex Capsules: 0.1 mg/kg
797997|NCT01405950|O3|Outcome|Dose Level 3|Zanaflex Capsules: 0.075 mg/kg
797998|NCT01405950|O2|Outcome|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
797999|NCT01405950|O1|Outcome|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
798000|NCT01405950|E2|Reported Event|Dose Level 2|Zanaflex Capsules : 0.05 mg/kg
798001|NCT01405950|E1|Reported Event|Dose Level 1|Zanaflex Capsules : 0.025 mg/kg
798002|NCT01405937|B3|Baseline|Total|Total of all reporting groups
798004|NCT01405937|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798005|NCT01405937|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798007|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798008|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798009|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798010|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798011|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798012|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798013|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798014|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798015|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798016|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798017|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798018|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798019|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798020|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798021|NCT01405937|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798022|NCT01405937|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798023|NCT01405937|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798024|NCT01405937|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV
798025|NCT01405924|B1|Baseline|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798026|NCT01405924|P1|Participant Flow|Fosaprepitant 150 mg|Women with breast cancer receiving anthracycline-cyclophosphamide (AC)-like chemotherapy and women with gynecological cancer receiving carboplatin-paclitaxel (CT) chemotherapy receive fosaprepitant 150 mg administered intravenously (IV) on Day 1 of Cycle 2 of chemotherapy
798027|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798028|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798029|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798030|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798031|NCT01405924|O2|Outcome|Fosaprepitant 150 mg: CT Chemotherapy|Women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798032|NCT01405924|O1|Outcome|Fosaprepitant 150 mg: AC-like Chemotherapy|Women with breast cancer receiving AC-like chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798033|NCT01405924|O1|Outcome|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798034|NCT01405924|E1|Reported Event|Fosaprepitant 150 mg|Women with breast cancer receiving AC-like chemotherapy and women with gynecological cancer receiving CT chemotherapy receive fosaprepitant 150 mg administered IV on Day 1 of Cycle 2 of chemotherapy
798035|NCT01405898|B3|Baseline|Total|Total of all reporting groups
798036|NCT01405898|B2|Baseline|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
798037|NCT01405898|B1|Baseline|Beetroot Juice|Beetroot juice 4 weeks 250ml daily
798038|NCT01405898|P2|Participant Flow|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
798039|NCT01405898|P1|Participant Flow|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
798046|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
798047|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
798048|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
798049|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
798050|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
798051|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
798052|NCT01405898|O2|Outcome|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
798053|NCT01405898|O1|Outcome|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
798054|NCT01405898|E2|Reported Event|Nitrate-free Beetroot Juice|Nitrate-free beetroot juice, 4 weeks 250ml daily
798055|NCT01405898|E1|Reported Event|Beetroot Juice|Beetroot juice, 4 weeks 250ml daily
798056|NCT01405820|B7|Baseline|Total|Total of all reporting groups
798057|NCT01405820|B6|Baseline|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
798058|NCT01405820|B5|Baseline|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
798059|NCT01405820|B4|Baseline|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
798060|NCT01405820|B3|Baseline|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
798061|NCT01405820|B2|Baseline|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
798062|NCT01405820|B1|Baseline|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
798063|NCT01405820|P6|Participant Flow|Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798064|NCT01405820|P5|Participant Flow|Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798065|NCT01405820|P4|Participant Flow|Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798066|NCT01405820|P3|Participant Flow|Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798067|NCT01405820|P2|Participant Flow|Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798068|NCT01405820|P1|Participant Flow|Natalizumab 300 mg Intravenous (IV) Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798069|NCT01405820|O6|Outcome|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
798070|NCT01405820|O5|Outcome|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
798071|NCT01405820|O4|Outcome|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
798072|NCT01405820|O3|Outcome|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
798073|NCT01405820|O2|Outcome|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
798074|NCT01405820|O1|Outcome|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
798075|NCT01405820|E12|Reported Event|Open-label Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798076|NCT01405820|E11|Reported Event|Open-label Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798077|NCT01405820|E10|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798078|NCT01405820|E9|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798079|NCT01405820|E8|Reported Event|Open-label Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798080|NCT01405820|E7|Reported Event|Open-label Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.
798081|NCT01405820|E6|Reported Event|Randomized Period: Natalizumab 150 mg SC Every 12 Weeks|Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
798082|NCT01405820|E5|Reported Event|Randomized Period: Natalizumab 150 mg IV Every 12 Weeks|Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
798083|NCT01405820|E4|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 12 Weeks|Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.
798084|NCT01405820|E3|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 12 Weeks|Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.
798085|NCT01405820|E2|Reported Event|Randomized Period: Natalizumab 300 mg SC Every 4 Weeks|Natalizumab 300 mg SC every 4 weeks for 60 weeks.
798086|NCT01405820|E1|Reported Event|Randomized Period: Natalizumab 300 mg IV Every 4 Weeks|Natalizumab 300 mg IV every 4 weeks for 60 weeks.
798087|NCT01405794|B1|Baseline|All Participants|
798088|NCT01405794|P1|Participant Flow|All Study Participants|All participants were dosed with the placebo (14 days), then they all had a 72hr washout period. Last all participants were dosed with the 32ppm Oral Silver for (14 days).
798089|NCT01405794|O2|Outcome|32ppm Oral Silver|
798090|NCT01405794|O1|Outcome|Placebo|
798091|NCT01405794|O2|Outcome|32ppm Oral Silver|
798092|NCT01405794|O1|Outcome|Placebo|
798093|NCT01405794|O2|Outcome|32ppm Oral Silver|
798094|NCT01405794|O1|Outcome|Placebo|
798095|NCT01405794|O2|Outcome|32ppm Oral Silver|
798096|NCT01405794|O1|Outcome|Placebo|
798097|NCT01405794|O2|Outcome|32ppm Oral Silver|
798098|NCT01405794|O1|Outcome|Placebo|
798099|NCT01405794|O2|Outcome|32ppm Oral Silver|
798100|NCT01405794|O1|Outcome|Placebo|
798101|NCT01405794|O2|Outcome|32ppm Oral Silver|
798102|NCT01405794|O1|Outcome|Placebo|
798103|NCT01405794|O2|Outcome|32ppm Oral Silver|
798104|NCT01405794|O1|Outcome|Placebo|
798105|NCT01405794|O2|Outcome|32ppm Oral Silver|
798106|NCT01405794|O1|Outcome|Placebo|
798107|NCT01405794|O2|Outcome|32ppm Oral Silver|
798108|NCT01405794|O1|Outcome|Placebo|
798109|NCT01405794|O2|Outcome|32ppm Oral Silver|
798110|NCT01405794|O1|Outcome|Placebo|
798111|NCT01405794|O2|Outcome|32ppm Oral Silver|
798112|NCT01405794|O1|Outcome|Placebo|
798113|NCT01405794|O2|Outcome|32ppm Oral Silver|
798114|NCT01405794|O1|Outcome|Placebo|
798115|NCT01405794|O2|Outcome|32ppm Oral Silver|
798116|NCT01405794|O1|Outcome|Placebo|
798117|NCT01405794|O2|Outcome|32ppm Oral Silver|
798118|NCT01405794|O1|Outcome|Placebo|
798119|NCT01405794|O2|Outcome|32ppm Oral Silver|
798120|NCT01405794|O1|Outcome|Placebo|
798121|NCT01405794|O2|Outcome|32ppm Oral Silver|
798122|NCT01405794|O1|Outcome|Placebo|
798123|NCT01405794|O2|Outcome|32ppm Oral Silver|
798124|NCT01405794|O1|Outcome|Placebo|
798125|NCT01405794|O2|Outcome|32ppm Oral Silver|
798126|NCT01405794|O1|Outcome|Placebo|
798127|NCT01405794|O2|Outcome|32ppm Oral Silver|
798128|NCT01405794|O1|Outcome|Placebo|
798129|NCT01405794|O2|Outcome|32ppm Oral Silver|
798130|NCT01405794|O1|Outcome|Placebo|
798131|NCT01405794|O2|Outcome|32ppm Oral Silver|
798132|NCT01405794|O1|Outcome|Placebo|
798133|NCT01405794|O2|Outcome|32ppm Oral Silver|
798134|NCT01405794|O1|Outcome|Placebo|
798135|NCT01405794|O2|Outcome|32ppm Oral Silver|
798136|NCT01405794|O1|Outcome|Placebo|
798137|NCT01405794|O2|Outcome|32ppm Oral Silver|
798138|NCT01405794|O1|Outcome|Placebo|
798139|NCT01405794|O2|Outcome|32ppm Oral Silver|
798140|NCT01405794|O1|Outcome|Placebo|
798141|NCT01405794|O2|Outcome|32ppm Oral Silver|
798142|NCT01405794|O1|Outcome|Placebo|
798143|NCT01405794|O2|Outcome|32ppm Oral Silver|
798144|NCT01405794|O1|Outcome|Placebo|
798145|NCT01405794|O2|Outcome|32ppm Oral Silver|
798146|NCT01405794|O1|Outcome|Placebo|
798147|NCT01405794|O2|Outcome|32ppm Oral Silver|
798148|NCT01405794|O1|Outcome|Placebo|
798149|NCT01405794|O2|Outcome|32ppm Oral Silver|
798150|NCT01405794|O1|Outcome|Placebo|
798151|NCT01405794|O2|Outcome|32ppm Oral Silver|
798152|NCT01405794|O1|Outcome|Placebo|
798153|NCT01405794|O2|Outcome|32ppm Oral Silver|
798154|NCT01405794|O1|Outcome|Placebo|
798155|NCT01405794|O2|Outcome|32ppm Oral Silver|
798156|NCT01405794|O1|Outcome|Placebo|
798157|NCT01405794|O2|Outcome|32ppm Oral Silver|
798158|NCT01405794|O1|Outcome|Placebo|
798159|NCT01405794|E2|Reported Event|Silver Biotics 32 Ppm Diluent|
798160|NCT01405794|E1|Reported Event|ASAP 32 Ppm Solution Experimental|
798161|NCT01405768|B3|Baseline|Total|Total of all reporting groups
798162|NCT01405768|B2|Baseline|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
798163|NCT01405768|B1|Baseline|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
798164|NCT01405768|P2|Participant Flow|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
798165|NCT01405768|P1|Participant Flow|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
798166|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
798167|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
798168|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
798169|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
798319|NCT01404611|E3|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
798170|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
798171|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
798172|NCT01405768|O2|Outcome|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
798173|NCT01405768|O1|Outcome|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
798174|NCT01405768|E2|Reported Event|Buffered Lidocaine|"Women in this arm will receive sodium bicarbonate buffered lidocaine mixed with epinephrine injected into their cervix prior to the LEEP procedure.~sodium bicarbonate buffered lidocaine: 8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix."
798175|NCT01405768|E1|Reported Event|Lidocaine Arm|Women in this arm will receive plain lidocaine with epinephrine injected into their cervix prior to the LEEP procedure.
798176|NCT01405742|B1|Baseline|Severe Hemophilia A|Subjects will be randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period.
798177|NCT01405742|P2|Participant Flow|Thrice-Weekly Then Once-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
798178|NCT01405742|P1|Participant Flow|Once-Weekly Then Thrice-Weekly FVIII|Subjects randomized to receive either once-weekly F.VIII at 40 IU/kg (Arm A) or thrice-weekly F.VIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm for the last 26 weeks, following a 72 hour washout period. Group 1, will receive Arm A for the first 26 weeks, and Arm B for the last 26 weeks. Group 2, will receive Arm B for the first 26 weeks and Arm A for the last 26 weeks.
798179|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
798180|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
798181|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
798182|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
798183|NCT01405742|O2|Outcome|Thrice Weekly FVIII|Subjects will be randomized to receive thrice-weekly FVIII at 40 IU/kg (Arm B) for the first 26 weeks of study. Then, at 26 weeks, they will cross-over to once-weekly FVIII at 40 IU/kg (Arm A) for weeks 26-52, following a 72 hour washout period.
798184|NCT01405742|O1|Outcome|Once Weekly FVIII|Subjects will be randomized to receive once-weekly FVIII at 40 IU/kg (Arm A) for the first 26 weeks. Then at 26 weeks, they will cross-over to thrice-weekly FVIII at 40 IU/kg (Arm B) for weeks 26-52, following a 72 hour washout period.
798185|NCT01405742|E2|Reported Event|Arm B Thrice-weekly F.VIII at 40 IU/kg|Subjects will be randomized to receive thrice-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (once-weekly) for the last 26 weeks, following a 72 hour washout period.
798186|NCT01405742|E1|Reported Event|Arm A Once-weekly F.VIII at 40 IU/kg|Subjects in Arm A will be randomized to receive either once-weekly F.VIII at 40 IU/kg for the first 26 weeks of study. Then, at 26 weeks, they will undergo “Cross-Over”, that is, switch to the alternative Study Arm (thrice-weekly) for the last 26 weeks, following a 72 hour washout period.
798187|NCT01405560|B1|Baseline|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798188|NCT01405560|P1|Participant Flow|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798189|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798190|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798191|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798192|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798193|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798194|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798195|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798196|NCT01405560|O1|Outcome|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798320|NCT01404611|E2|Reported Event|DF277|"Ear drops~DF277: Ear drops"
798197|NCT01405560|E1|Reported Event|Vaniprevir 24 Week Arm|Participants receive 24 weeks of vaniprevir (300 mg twice daily) with concomitant peg-IFN and RBV treatment
798198|NCT01405508|B5|Baseline|Total Title|
798199|NCT01405508|B4|Baseline|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798200|NCT01405508|B3|Baseline|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
798201|NCT01405508|B2|Baseline|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798202|NCT01405508|B1|Baseline|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798203|NCT01405508|P4|Participant Flow|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798204|NCT01405508|P3|Participant Flow|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
798205|NCT01405508|P2|Participant Flow|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798206|NCT01405508|P1|Participant Flow|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798207|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798208|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
798316|NCT01404611|O3|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
798317|NCT01404611|O2|Outcome|DF277|"Ear drops~DF277: Ear drops"
798321|NCT01404611|E1|Reported Event|DF289|"Ear drops~DF289: Ear drops"
798322|NCT01404572|B1|Baseline|All Treated|All participants tasted atazanavir, 15 mg/5 mL, in the current formulation and 2 new powder for oral use formulations in 3 different sequences
798352|NCT01404572|E1|Reported Event|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A)
798209|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798210|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798211|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798212|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
798213|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798214|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798215|NCT01405508|O4|Outcome|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798216|NCT01405508|O3|Outcome|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
798217|NCT01405508|O2|Outcome|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798218|NCT01405508|O1|Outcome|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798219|NCT01405508|E4|Reported Event|Brivaracetam (BRV) Tablets / BRV Infusion|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by Brivaracetam intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798279|NCT01404988|E3|Reported Event|Arm 3|"Attention Placebo Group (API) - patients will receive non-tailored counseling on general health topics.~Telephone-Delivered API: Attention Placebo Intervention will be delivered over the phone"
798318|NCT01404611|O1|Outcome|DF289|"Ear drops~DF289: Ear drops"
798220|NCT01405508|E3|Reported Event|Brivaracetam (BRV) Tablets / BRV Bolus|"Subjects will receive Brivaracetam (BRV) tablets for one week followed by BRV bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake bid for the fourth week"
798221|NCT01405508|E2|Reported Event|Placebo Tablets / Brivaracetam Infusion|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) intravenous infusion for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive BRV tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798222|NCT01405508|E1|Reported Event|Placebo Tablets / Brivaracetam Bolus|"Subjects will receive Placebo (PBO) tablets for one week followed by Brivaracetam (BRV) bolus for 4.5 days.~Down-Titration:~If subject discontinues the study during the Run-In Period, then the subject will receive the treatment that he/she was assigned during Run-In~If subject discontinues during the Evaluation Period or after Day 12, the subject will receive Placebo tablets during Down-Titration:~Tablets will be provided for 4 weeks; 75 mg / intake BID for the first week, 50 mg / intake BID for the second week, 25 mg / intake BID for the third week, 10 mg / intake BID for the fourth week"
798223|NCT01405469|B1|Baseline|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
798224|NCT01405469|P1|Participant Flow|POEM Patients|pilot group of achalasia patients who received POEM Treatment: Endoscopic Myotomy of the Lower Esophageal Sphincter
798225|NCT01405469|O1|Outcome|POEM Patients|pilot study, first 16 patients who received POEM for treatment of achalasia
798226|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798227|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798228|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798229|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798230|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798231|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798232|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798233|NCT01405469|O1|Outcome|POEM Patients|pilot group of achalasia patients who received POEM treatment
798234|NCT01405469|E1|Reported Event|POEM Patients|pilot group of achalasia patients who received POEM treatment
798235|NCT01405313|B1|Baseline|Modified ASV/Conventional ASV|Therapy used was Modified ASV and then Conventional ASV
798236|NCT01405313|P1|Participant Flow|First Modified ASV Then Conventional ASV|Patients receive Modified ASV algorithm as therapy for 1 night, then Conventional ASV for 1 night
798237|NCT01405313|O2|Outcome|Conventional ASV ODI|1 night of conventional ASV therapy with full polysomnography measurements
798238|NCT01405313|O1|Outcome|Modified ASV ODI|1 night of modified ASV therapy with full polysomnography measurements
798239|NCT01405313|O2|Outcome|Conventional ASV AHI|1 night of conventional ASV therapy with full polysomnography measurements
798240|NCT01405313|O1|Outcome|Modified ASV AHI|1 night of modified ASV therapy with full polysomnography measurements
798241|NCT01405313|E2|Reported Event|Modified ASV|Intervention was modified ASV therapy
798242|NCT01405313|E1|Reported Event|Conventional ASV|Intervention was conventional ASV therapy
798243|NCT01405027|B3|Baseline|Total|Total of all reporting groups
798244|NCT01405027|B2|Baseline|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798245|NCT01405027|B1|Baseline|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798246|NCT01405027|P2|Participant Flow|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798247|NCT01405027|P1|Participant Flow|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798248|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798249|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798250|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798251|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798252|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but without clinical trial experience with an HCV protease inhibitor received patient education and management skills training from Hepatology Centers of Educational Expertise (HCEEs) during four (4) educational interventions.~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798253|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor. HCEE investigators provided patient education and management skills training during four (4) educational interventions to Community Site investigators.~Patient education and management skills training: Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798254|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798255|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798256|NCT01405027|O2|Outcome|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798257|NCT01405027|O1|Outcome|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798258|NCT01405027|E2|Reported Event|Group B - Community Sites|"Group B - community physicians treating HCV but no clinical trial experience with an HCV protease inhibitor~Educational Intervention: Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798259|NCT01405027|E1|Reported Event|Group A - HCEE|"Group A - CLDF Hepatology Centers of Educational Expertise (HCEE) are hepatologists experienced in educating health professionals about current developments in the management of chronic liver disease and with clinical trial experience using an HCV protease inhibitor.~No Intervention: Deliver patient education and management skills training to community sites during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes."
798260|NCT01404988|B4|Baseline|Total|Total of all reporting groups
798261|NCT01404988|B3|Baseline|Attention Placebo Intervention (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
798278|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI) -|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
798315|NCT01404611|P1|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
798262|NCT01404988|B2|Baseline|Behavioral and Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
798263|NCT01404988|B1|Baseline|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.Behavioral Intervention will be delivered over the phone.
798264|NCT01404988|P3|Participant Flow|Attention Placebo Group (API) -|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
798265|NCT01404988|P2|Participant Flow|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
798266|NCT01404988|P1|Participant Flow|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement over the phone.
798267|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
798268|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
798269|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|"Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Behavioral Intervention will be delivered over the phone."
798270|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
798271|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education. Behavioral and Environmental Intervention will be delivered over the phone
798272|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
798273|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
798274|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
798275|NCT01404988|O1|Outcome|Comprehensive Behavioral Intervention (BI)|Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement. Behavioral Intervention will be delivered over the phone.
798276|NCT01404988|O3|Outcome|Attention Placebo Group (API)|Patients will receive non-tailored counseling on general health topics. Attention Placebo Intervention will be delivered over the phone
798277|NCT01404988|O2|Outcome|Behavioral & Environmental Intervention (BEI)|Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.Behavioral and Environmental Intervention will be delivered over the phone
798416|NCT01404208|E2|Reported Event|Sugar Pill|Placebo: Sugar pill
798280|NCT01404988|E2|Reported Event|Arm 2|"Behavioral & Environmental Intervention (BEI) - Participants in this arm will receive the BI but will also receive environmental tailoring. Environmental Tailoring consists of Built Environment Tailoring (BET) where the intervention will incorporate aspects from the patients' environment, such as accessibility of health food stores or recreational facilities. Environmental Tailoring also consists of Human Environment Tailoring (HET) which incorporates patients' social support. Caregivers will be enrolled for patients in this arm of the study and they will also receive health education.~Telephone-Delivered BEI: Behavioral and Environmental Intervention will be delivered over the phone"
798281|NCT01404988|E1|Reported Event|Arm 1|"Comprehensive behavioral intervention (BI) - Participants will receive the BI that is based on the transtheoretical model, which targets stage of change, decisional balance and self-efficacy, while also assessing and counseling regarding the barriers and facilitators of HF care, and to improve self-regulatory care such as self-monitoring, self-evaluation, feedback and reinforcement.~Telephone-Delivered BI: Behavioral Intervention will be delivered over the phone."
798282|NCT01404936|B1|Baseline|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
798283|NCT01404936|P1|Participant Flow|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
798284|NCT01404936|O1|Outcome|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
798285|NCT01404936|E1|Reported Event|Interferon-2A + Chemotherapy|Interferon-2A 4 (x106 IU/m^2) subcutaneously Day 1 - 4 + ABVD Chemotherapy on Day 4 (ABVD: Adriamycin 25 mg/m2 intravenous (IV), Bleomycin 10 mg/m^2 IV, Velban 6 mg/m2 IV, and Dacarbazine 375 mg/m2 IV)
798286|NCT01404923|B3|Baseline|Total|Total of all reporting groups
798287|NCT01404923|B2|Baseline|Standard of Care|anti spasmodic agents: best standard of care prescriptions
798288|NCT01404923|B1|Baseline|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
798289|NCT01404923|P2|Participant Flow|Standard of Care|anti spasmodic agents: best standard of care prescriptions
798290|NCT01404923|P1|Participant Flow|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
798291|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
798292|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
798293|NCT01404923|O2|Outcome|Standard of Care|anti spasmodic agents: best standard of care prescriptions
798294|NCT01404923|O1|Outcome|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
798295|NCT01404923|E2|Reported Event|Standard of Care|anti spasmodic agents: best standard of care prescriptions
798296|NCT01404923|E1|Reported Event|Meteospasmyl|alverine citrate, simeticone: on-demand therapy
798297|NCT01404832|B1|Baseline|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
798298|NCT01404832|P1|Participant Flow|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
798299|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
798300|NCT01404832|O1|Outcome|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
798301|NCT01404832|E1|Reported Event|Patients Whose PPI Was Changed to Lansoprazole|In 21 patients taking omeprazole ≥80 mg/day, the PPI was changed to lansoprazole 30 mg BID before breakfast and dinner.
798302|NCT01404650|B1|Baseline|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
798303|NCT01404650|P1|Participant Flow|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
798304|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
798305|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
798306|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
798307|NCT01404650|O1|Outcome|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
798308|NCT01404650|E1|Reported Event|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles repeated every 21 days. Patients are evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter until evidence of disease progression or intolerable toxicity.
798309|NCT01404611|B4|Baseline|Total|Total of all reporting groups
798310|NCT01404611|B3|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
798311|NCT01404611|B2|Baseline|DF277|"Ear drops~DF277: Ear drops"
798312|NCT01404611|B1|Baseline|DF289|"Ear drops~DF289: Ear drops"
798313|NCT01404611|P3|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
798314|NCT01404611|P2|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
798323|NCT01404572|P3|Participant Flow|Treatment Sequence C, A, B|Participants in this sequence first tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose followed by at least a 45-minute washout period. Next, participants tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame.
798324|NCT01404572|P2|Participant Flow|Treatment Sequence B, C, A|Participants in this sequence first tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following at least a 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose. Following another 45-minute washout period, participants then tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame.
798325|NCT01404572|P1|Participant Flow|Treatment Sequence A, B, C|Participants in this sequence first tasted (Treatment A) atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame followed by at least a 45-minute washout period. Next, participants tasted (Treatment B) atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame. Following another at least 45-minute washout period, participants tasted (Treatment C) atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose.
798326|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798327|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798328|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798329|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798330|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798331|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798332|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798333|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798334|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798335|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C).
798336|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798337|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798338|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame+ 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798339|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798340|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798341|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798342|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted received atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798343|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798344|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798345|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798346|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798347|NCT01404572|O3|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798348|NCT01404572|O2|Outcome|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798349|NCT01404572|O1|Outcome|Atazanavir, 15 mg/5 mL, With 10% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, powder for oral use (POU) in the current formulation with 10% aspartame (Treatment A).
798350|NCT01404572|E3|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame + 0.53% Sucralose|Participants tasted atazanavir, 15 mg/5 mL, in the second new POU formulation (POU2) with 4.2% aspartame plus 0.53% sucralose (Treatment C)
798351|NCT01404572|E2|Reported Event|Atazanavir, 15 mg/5 mL, With 4.2% Aspartame|Participants tasted atazanavir, 15 mg/5 mL, in the first new POU (POU1) with 4.2% aspartame (Treatment B)
798353|NCT01404559|B3|Baseline|Total|Total of all reporting groups
798354|NCT01404559|B2|Baseline|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
798355|NCT01404559|B1|Baseline|Transtibial Amputees|This arm included unilateral transtibial amputees who who were crossed over into 3 different prosthetic feet and assessed per intervention.
798356|NCT01404559|P4|Participant Flow|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
798357|NCT01404559|P3|Participant Flow|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3(Endolite Elite Blade; 1 week) the prosthetic foot 1(Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week).~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
798358|NCT01404559|P2|Participant Flow|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 3(Endolite Elite Blade; 1 week).~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
798359|NCT01404559|P1|Participant Flow|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1 (Ossur Variflex; 1 week) then prosthetic foot 2(Ossur Ceterus; 1 week) then prosthetic foot 3(Endolite Elite Blade;1 week).~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
798360|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
798361|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
798362|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
798363|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
798364|NCT01404559|O4|Outcome|Non-amputee Controls|"This was an observational arm including non-amputees who were assessed as non-impaired control subjects. There are no interventions in this observational arm of the study.~No intervention. Control group.: There are no interventions in this observational arm of the study."
798365|NCT01404559|O3|Outcome|Prosthetic Foot 3 (Endolite Elite Blade)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 3.~Endolite Elite Blade prosthetic foot: Multi-axial prosthetic foot"
798366|NCT01404559|O2|Outcome|Prosthetic Foot 2 (Ossur Ceterus)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 2.~Ossur Ceterus prosthetic foot: Shock-absorbing prosthetic foot"
798367|NCT01404559|O1|Outcome|Prosthetic Foot 1 (Ossur Variflex)|"This arm included unilateral transtibial amputees who who were assessed while using prosthetic foot 1.~Ossur Variflex prosthetic foot: Lightweight energy-storing prosthetic foot"
798368|NCT01404559|E1|Reported Event|Unilateral Transtibial Amputees|This arm/group included unilateral transtibial amputees who who were assessed three times. They were exposed to 3 different prosthetic feet interventions.
798369|NCT01404429|B3|Baseline|Total|Total of all reporting groups
798370|NCT01404429|B2|Baseline|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798371|NCT01404429|B1|Baseline|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798372|NCT01404429|P2|Participant Flow|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
798373|NCT01404429|P1|Participant Flow|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
798374|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
798375|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
798376|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798377|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798378|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798379|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798380|NCT01404429|O2|Outcome|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798381|NCT01404429|O1|Outcome|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) which was then escalated by 2.5 mg every 2 weeks (max 25 mg weekly)
798382|NCT01404429|E2|Reported Event|Methotrexate 15 mg Per Week|Patients started on 15 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
798383|NCT01404429|E1|Reported Event|Methotrexate 7.5 mg Per Week|Patients started on 7.5 mg of oral methotrexate (weekly) increased by 2.5 mg every 2 weeks (max 25mg weekly)
798384|NCT01404260|B3|Baseline|Total|Total of all reporting groups
798385|NCT01404260|B2|Baseline|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
798871|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798386|NCT01404260|B1|Baseline|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
798387|NCT01404260|P2|Participant Flow|Arm B: Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
798388|NCT01404260|P1|Participant Flow|Arm A: Gefitinib + Gemcitabine + Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
798389|NCT01404260|O2|Outcome|Arm B: Gemcitabine +Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
798390|NCT01404260|O1|Outcome|Arm A: Gefitinib+Gemcitabine +Carboplatin|Arm A: Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, Gefitinib 250mg/d every cycle d15-25, and Gefitinib 250mg/d from d15 of last cycle until disease progression
798391|NCT01404260|E2|Reported Event|Arm B|gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum4 cycles, observation until disease progression
798392|NCT01404260|E1|Reported Event|Arm A|"Arm A: gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles, gefitinib 250mg/d every cycle d15-25, and gefitinib 250mg/d from d15 of last cycle until disease progression~gefitinib: gefitinib 250mg/d every cycle d15-25,and gefitinib 250mg/d from d15 of last cycle until disease progression"
798393|NCT01404234|B1|Baseline|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798394|NCT01404234|P1|Participant Flow|AZLI|Participants received three 28-day courses of Aztreonam for Inhalation Solution (AZLI), each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798395|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798396|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798397|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798398|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798399|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798400|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798401|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798402|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798403|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798404|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798405|NCT01404234|O1|Outcome|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798406|NCT01404234|E1|Reported Event|AZLI|Participants received three 28-day courses of AZLI, each followed by 28 days off-treatment. AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
798407|NCT01404208|B3|Baseline|Total|Total of all reporting groups
798408|NCT01404208|B2|Baseline|Sugar Pill|Placebo: Sugar pill
798409|NCT01404208|B1|Baseline|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
798410|NCT01404208|P2|Participant Flow|Sugar Pill|Placebo: Sugar pill
798411|NCT01404208|P1|Participant Flow|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
798412|NCT01404208|O2|Outcome|Sugar Pill|Placebo: Sugar pill
798413|NCT01404208|O1|Outcome|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
798414|NCT01404208|O2|Outcome|Sugar Pill|Placebo: Sugar pill
798415|NCT01404208|O1|Outcome|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
798417|NCT01404208|E1|Reported Event|D-Cycloserine|D-Cycloserine: 25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
798418|NCT01404078|B3|Baseline|Total|Total of all reporting groups
798515|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798419|NCT01404078|B2|Baseline|Polycap Double Dose Plus Potassium|"Patients in this arm received one dose of low strength Polycap with potassium~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
798420|NCT01404078|B1|Baseline|Polycap Single Dose|Patients in this arm received single dose of low strength Polycap only Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
798421|NCT01404078|P2|Participant Flow|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
798422|NCT01404078|P1|Participant Flow|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
798423|NCT01404078|O2|Outcome|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
798424|NCT01404078|O1|Outcome|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
798425|NCT01404078|E2|Reported Event|One Dose of Low Srength Polycap|"Patients in this arm will receive one dose of low strength Polycap~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
798426|NCT01404078|E1|Reported Event|Two Doses of Low Strength Polycap|"Patients in this arm will receive 2 doses of low strength Polycap.~Indian Polycap: Polycap contains 5 drugs at half doses Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin"
798427|NCT01404039|B10|Baseline|Total|Total of all reporting groups
798428|NCT01404039|B9|Baseline|Mental Imagery (MI) - Control|
798429|NCT01404039|B8|Baseline|Mental Imagery (MI) - Real|
798430|NCT01404039|B7|Baseline|Observational Task (OT) - Control|
798431|NCT01404039|B6|Baseline|Observational Task (OT) - Real|
798432|NCT01404039|B5|Baseline|Somatosensory Learning (SL) Control Group|
798433|NCT01404039|B4|Baseline|Somatosensory Activation (S Activation)|
798434|NCT01404039|B3|Baseline|Somatosensory Learning (SL Blind)|
798435|NCT01404039|B2|Baseline|Somatosensory Learning (SL Sighted)|
798436|NCT01404039|B1|Baseline|Motor Learning (ML)|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
798437|NCT01404039|P13|Participant Flow|tDCS - Sham|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
798438|NCT01404039|P12|Participant Flow|tDCS - Active|This experimental arm will be conducted in a cross-over design (active tDCS and sham tDCS).
798439|NCT01404039|P11|Participant Flow|Mental Imagery (MI) - Control Group|Control Group - Mental Imagery: Subjects will be asked to perform simple mental math calculations for 20 minutes. (ex. adding or subtracting a one digit number from a starting number (1+1=2; 2+1=3; 3+1= 4 and so on.)
798440|NCT01404039|P10|Participant Flow|Mental Imagery (MI)|Mental Imagery: Subjects will be seated in a chair and are asked to keep their arm and hand muscles fully relaxed. Then they will be asked to imagine repetitive movement of the left index finger to the left thumb for 5 minutes. Subjects then will be asked to imagine sequential movement of left finger to left thumb (thumb to 2nd, 3rd, 4th, 5th) for 5 minutes.
798441|NCT01404039|P9|Participant Flow|Observational Task (OT) - Control Group|Control Group -- Observational Task: Subjects in this group will be asked to watch a video of random geometric forms for the same duration of time as those in the observational task group.
798442|NCT01404039|P8|Participant Flow|Observational Task (OT)|Observational Task: Subjects in this group will watch a 10 second video of a right-handed person performing movements of their left index finger at a 1 Hz rate on a screen at a distance of 1 meter away. Subjects will be instructed to watch the video without any other specific instruction.
798443|NCT01404039|P7|Participant Flow|Somatosensory Learning (SL) Control Group|"In this arm,the subjects will not receive any somatosensory input (SL control group).~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
798444|NCT01404039|P6|Participant Flow|Somatosensory Activation (S Activation)|"In this arm, subject will receive simple sensory stimulation over their left index finger - Sactivation.~There will be an anticipated total of 10 subjects in this experimental arm.This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
798445|NCT01404039|P5|Participant Flow|Somatosensory Learning (SL Blind)|"In this arm, subject will perform sensory Learning without visual feedback - SL blind.~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
798446|NCT01404039|P4|Participant Flow|Somatosensory Learning (SL Sighted)|"In this arm, subject will perform sensory Learning with visual feedback - SL sighted.~There will be an anticipated total of 10 subjects in this experimental arm. This experimental arm will be conducted in a parallel design with 4 groups (SL sighted, SL blind, Sactivation, SL control)."
798447|NCT01404039|P3|Participant Flow|Motor Learning (ML) MLcontrol Group/MLsighted/MLblind|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
798509|NCT01403376|B1|Baseline|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798448|NCT01404039|P2|Participant Flow|Motor Learning (ML) MLblind/MLcontrol/MLsighted|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
798513|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798449|NCT01404039|P1|Participant Flow|Motor Learning - MLsighted/MLblind/MLcontrol|This arm will be conducted as a cross-over design. The subjects will undergo the three interventions listed (motor learning with visual feedback, motor learning without visual feedback, and control group) in a counterbalanced randomized order. There will be at least 24 hours between each experimental session.
798450|NCT01404039|O11|Outcome|Mental Imagery (MI) - MI Control|
798451|NCT01404039|O10|Outcome|Mental Imagery (MI) - MI Real|
798452|NCT01404039|O9|Outcome|Observational Task (OT)- OT Control|
798453|NCT01404039|O8|Outcome|Observational Task (OT)- OT Real|
798454|NCT01404039|O7|Outcome|Somatosensory Learning (SL)-SL Control|
798455|NCT01404039|O6|Outcome|Somatosensory Learning (SL)-SL Activation|
798456|NCT01404039|O5|Outcome|Somatosensory Learning (SL)-SL Blind|
798457|NCT01404039|O4|Outcome|Somatosensory Learning (SL)- SL Sighted|
798458|NCT01404039|O3|Outcome|Motor Learning - ML Control|
798459|NCT01404039|O2|Outcome|Motor Learning -ML Blind|
798460|NCT01404039|O1|Outcome|Motor Learning (ML)-Sighted|
798461|NCT01404039|E11|Reported Event|Mental Imagery (MI) - Control|
798462|NCT01404039|E10|Reported Event|Mental Imagery (MI) - Real|
798463|NCT01404039|E9|Reported Event|Observational Task (OT) - Control|
798464|NCT01404039|E8|Reported Event|Observational Task (OT) - Real|
798465|NCT01404039|E7|Reported Event|Somatosensory Learning (SL) Control|
798466|NCT01404039|E6|Reported Event|Somatosensory Activation (SA)|
798467|NCT01404039|E5|Reported Event|Somatosensory Learning (SL) Blind|
798468|NCT01404039|E4|Reported Event|Somatosensory Learning (SL) Sighted|
798469|NCT01404039|E3|Reported Event|Motor Learning (ML) Control|
798470|NCT01404039|E2|Reported Event|Motor Learning (ML) Blind|
798471|NCT01404039|E1|Reported Event|Motor Learning (ML) Sighted|
798472|NCT01403987|B4|Baseline|Total|Total of all reporting groups
798473|NCT01403987|B3|Baseline|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
798474|NCT01403987|B2|Baseline|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
798475|NCT01403987|B1|Baseline|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
798476|NCT01403987|P3|Participant Flow|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
798477|NCT01403987|P2|Participant Flow|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
798478|NCT01403987|P1|Participant Flow|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
798479|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
798480|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
798481|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
798482|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
798483|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
798484|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
798485|NCT01403987|O3|Outcome|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
798486|NCT01403987|O2|Outcome|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
798487|NCT01403987|O1|Outcome|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
798510|NCT01403376|P3|Participant Flow|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798488|NCT01403987|E3|Reported Event|"Intensive Education Arm (Pager Arm)"|This group will receive the residency teaching, the specialist lecture, the pocket card, and have access to a pager carried by a gastroenterology fellow for personal assistance in performing paracentesis.
798514|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798489|NCT01403987|E2|Reported Event|Intermediate Education Arm|In addition to the teaching provided by the residency program, the intermediate education group will receive a dedicated lecture by a gastroenterology fellow designed to teach consensus guidelines and their rationale in management of ascites. They will also receive a pocket card noting specific indications for paracentesis, and a brief summary of guidelines.
798490|NCT01403987|E1|Reported Event|Control Arm|Control group will receive standard teaching by the Residency Program regarding management of ascites and performance of paracentesis.
798491|NCT01403805|B3|Baseline|Total|Total of all reporting groups
798492|NCT01403805|B2|Baseline|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
798493|NCT01403805|B1|Baseline|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
798494|NCT01403805|P2|Participant Flow|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
798495|NCT01403805|P1|Participant Flow|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
798496|NCT01403805|O1|Outcome|Died Before Oral Care Starting|Number of resident died before the start of oral care
798497|NCT01403805|O1|Outcome|Reject Vaccine|Number of resident to reject vaccine
798498|NCT01403805|O1|Outcome|Reject Oral Care|Number of resident to reject oral care
798499|NCT01403805|O1|Outcome|Leaving Nursing Home|Numer of resident for leaving nursing home
798500|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
798501|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
798502|NCT01403805|O2|Outcome|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
798503|NCT01403805|O1|Outcome|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
798504|NCT01403805|E2|Reported Event|Oral Care With Influenza and Pneumococcal Vaccines|"Number of Participants with oral care and both an influenza vaccines (Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.) and a pneumococcal vaccine (PNEUMOVAX NP, 0.5ml, MSD Co.Ltd.) How to do oral care is the following;~1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room. At the same time, we taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material."
798505|NCT01403805|E1|Reported Event|Influenza Vaccine|Number of Participants with only an influenza vaccine(Flubik HA, 0.5ml, Mitsubishi Tanabe Pharm. Co.Ltd.).
798506|NCT01403376|B4|Baseline|Total|Total of all reporting groups
798507|NCT01403376|B3|Baseline|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798508|NCT01403376|B2|Baseline|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798511|NCT01403376|P2|Participant Flow|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798512|NCT01403376|P1|Participant Flow|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798516|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798517|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798518|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798519|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798520|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798521|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798522|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798523|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798524|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798525|NCT01403376|O3|Outcome|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798526|NCT01403376|O2|Outcome|Teriflunomide 14 mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798527|NCT01403376|O1|Outcome|Teriflunomide 7 mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798528|NCT01403376|E3|Reported Event|IFN-β-1|Influenza vaccine in participants treated with a stable dose of interferon-β-1 (IFN-β-1) for at least 6 months
798529|NCT01403376|E2|Reported Event|Teriflunomide 14mg|Influenza vaccine in participants treated with teriflunomide 14 mg for at least 6 months
798530|NCT01403376|E1|Reported Event|Teriflunomide 7mg|Influenza vaccine in participants treated with teriflunomide 7 mg for at least 6 months
798531|NCT01403194|B1|Baseline|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
798532|NCT01403194|P1|Participant Flow|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
798533|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
798534|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
798535|NCT01403194|O1|Outcome|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
798536|NCT01403194|E1|Reported Event|CPAP/Bi-PAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
798537|NCT01403090|B1|Baseline|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
798538|NCT01403090|P1|Participant Flow|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
798539|NCT01403090|O1|Outcome|Angel Catheter|Angel Catheter Placement : The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
798540|NCT01403090|E1|Reported Event|Angel Catheter|
798541|NCT01403051|B3|Baseline|Total|Total of all reporting groups
798542|NCT01403051|B2|Baseline|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798543|NCT01403051|B1|Baseline|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798544|NCT01403051|P2|Participant Flow|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798590|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798864|NCT01402102|B2|Baseline|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798545|NCT01403051|P1|Participant Flow|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798595|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798546|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798547|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798548|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798549|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798550|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798551|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798552|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798553|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798554|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798555|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798556|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798592|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798557|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798558|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798559|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798560|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798561|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798562|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798563|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798564|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798565|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798566|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798567|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798568|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla)~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798591|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798569|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798570|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798571|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798572|NCT01403051|O2|Outcome|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798573|NCT01403051|O1|Outcome|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798574|NCT01403051|E2|Reported Event|Arm B: Vitamin D3 Placebo and Calcium Placebo Plus EFV/FTC/TDF|"The participants were administered a placebo for vitamin D3, a placebo for calcium carbonate, and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Placebo for vitamin D3: A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.~Placebo for calcium carbonate: A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798575|NCT01403051|E1|Reported Event|Arm A: Vitamin D3 and Calcium Carbonate Plus EFV/FTC/TDF|"The participants were administered vitamin D3, calcium carbonate and FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla).~Vitamin D3: One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.~Calcium Carbonate: Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.~Atripla: FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach."
798576|NCT01402986|B5|Baseline|Total|Total of all reporting groups
798577|NCT01402986|B4|Baseline|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798578|NCT01402986|B3|Baseline|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798579|NCT01402986|B2|Baseline|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798580|NCT01402986|B1|Baseline|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798581|NCT01402986|P4|Participant Flow|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798582|NCT01402986|P3|Participant Flow|Placebo, Q2/4W - Cohort 2|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798583|NCT01402986|P2|Participant Flow|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798584|NCT01402986|P1|Participant Flow|Placebo, Q2W - Cohort 1|Participants received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798585|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798586|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798587|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798588|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798589|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798593|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798594|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798596|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798597|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798598|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798599|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798600|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798601|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798602|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798603|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798604|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798605|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798606|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798607|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798608|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798609|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798610|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798611|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798612|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798613|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798614|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798615|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798616|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798617|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798618|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798619|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798620|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798621|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798622|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798623|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798624|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798625|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798626|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798627|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798628|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798629|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798630|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798631|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798632|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798633|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798634|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798635|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798636|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798637|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798638|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798639|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798640|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798641|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798642|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798643|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798644|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798645|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798646|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798647|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798648|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798649|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798650|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798651|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798652|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798653|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798654|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798655|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798656|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798657|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798658|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798659|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798660|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798661|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798662|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798663|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798664|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798665|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798666|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798667|NCT01402986|O1|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798668|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798669|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798670|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798671|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798672|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798673|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798674|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798675|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798676|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798677|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798678|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798679|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798680|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798681|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798682|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798683|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798684|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798685|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798686|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798687|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798688|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798689|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798690|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798691|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798692|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798693|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798694|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798695|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798696|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798697|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798698|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798699|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798700|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798701|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798702|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798703|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798704|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798705|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798706|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798707|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798708|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798709|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798710|NCT01402986|O3|Outcome|Tralokinumab 300 mg, Q2/4W - Cohort 2|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798711|NCT01402986|O2|Outcome|Tralokinumab 300 mg, Q2W - Cohort 1|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798712|NCT01402986|O1|Outcome|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798713|NCT01402986|E3|Reported Event|Tralokinumab 300 mg Q2/4W|Participants received tralokinumab 300 mg subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798714|NCT01402986|E2|Reported Event|Tralokinumab 300 mg Q2W|Participants received tralokinumab 300 milligram (mg) subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
798715|NCT01402986|E1|Reported Event|Placebo Total|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks, and participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for 12 weeks followed by every 4 weeks (Q4W) for 38 weeks (Q2/4W) for a total of 16 doses.
798716|NCT01402947|B3|Baseline|Total|Total of all reporting groups
798717|NCT01402947|B2|Baseline|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
798718|NCT01402947|B1|Baseline|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
798719|NCT01402947|P2|Participant Flow|MMX Mesalazine/Mesalamine + Ciprofloxacin First|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for first intervention; then MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for second intervention
798720|NCT01402947|P1|Participant Flow|MMX Placebo + Ciprofloxacin First|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4 for first intervention; then MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4 for second intervention
798721|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
798722|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
798723|NCT01402947|O2|Outcome|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
798724|NCT01402947|O1|Outcome|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
798725|NCT01402947|E2|Reported Event|MMX Mesalazine/Mesalamine + Ciprofloxacin|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
798834|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798726|NCT01402947|E1|Reported Event|MMX Placebo + Ciprofloxacin|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, and a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
798727|NCT01402869|B4|Baseline|Total|Total of all reporting groups
798728|NCT01402869|B3|Baseline|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
798729|NCT01402869|B2|Baseline|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798730|NCT01402869|B1|Baseline|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798731|NCT01402869|P3|Participant Flow|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
798732|NCT01402869|P2|Participant Flow|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798733|NCT01402869|P1|Participant Flow|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798734|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
798735|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798736|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798737|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
798738|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798739|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798740|NCT01402869|O3|Outcome|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
798741|NCT01402869|O2|Outcome|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798742|NCT01402869|O1|Outcome|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798743|NCT01402869|E3|Reported Event|No Local Anesthetic|No local anesthetic was administered prior to restorative dental treatment-Negative control
798744|NCT01402869|E2|Reported Event|Lidocaine|2.5mg/kg of 2% lidocaine with 1:100,000 epinephrine administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798745|NCT01402869|E1|Reported Event|Prilocaine|5mg/kg of 4% prilocaine plain administered via infiltration into multiple sites of the buccal mucosa of the mouth 1 time prior to start of restorative dental treatment
798746|NCT01402817|B1|Baseline|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
798747|NCT01402817|P1|Participant Flow|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
798748|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
798749|NCT01402817|O1|Outcome|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.
798750|NCT01402817|E1|Reported Event|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg.The maximum dose for children is 15mg/m2/day.
798751|NCT01402700|B1|Baseline|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
798835|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798752|NCT01402700|P1|Participant Flow|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
798753|NCT01402700|O1|Outcome|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
798754|NCT01402700|E1|Reported Event|Visi-Pro™ Balloon Expandable Stent System|"The objective of the study is to confirm the safety and effectiveness of the Visi-Pro stent in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Visi-Pro™ Balloon Expandable Stent System: Implantation of one or more study devices in the common and/or external iliac artery."
798755|NCT01402570|B1|Baseline|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
798756|NCT01402570|P1|Participant Flow|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
798757|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
798758|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
798759|NCT01402570|O1|Outcome|Study Group|All subjects took a three month trials of 1,000 mg of glutathione supplement
798760|NCT01402570|O1|Outcome|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
798761|NCT01402570|E1|Reported Event|Study Group|All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid).
798762|NCT01402427|B3|Baseline|Total|Total of all reporting groups
798763|NCT01402427|B2|Baseline|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798764|NCT01402427|B1|Baseline|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798765|NCT01402427|P2|Participant Flow|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798766|NCT01402427|P1|Participant Flow|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798767|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798768|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798769|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798770|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798771|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798772|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798773|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798774|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798775|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798776|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798777|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798778|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798779|NCT01402427|O2|Outcome|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798780|NCT01402427|O1|Outcome|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798781|NCT01402427|E2|Reported Event|Placebo|Placebo: Intraarterial administration of 10 mL saline.
798782|NCT01402427|E1|Reported Event|Verapamil|Verapamil: Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
798783|NCT01402284|B1|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798836|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798837|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798838|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798839|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798840|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798841|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798842|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798843|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798865|NCT01402102|B1|Baseline|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798866|NCT01402102|P2|Participant Flow|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798867|NCT01402102|P1|Participant Flow|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798868|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798869|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798870|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798784|NCT01402284|P1|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone Therapy|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798785|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798786|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798787|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798788|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798789|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798790|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798844|NCT01402128|E2|Reported Event|Placebo|Placebo for 12 weeks
798845|NCT01402128|E1|Reported Event|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798846|NCT01402115|B3|Baseline|Total|Total of all reporting groups
798847|NCT01402115|B2|Baseline|Placebo|Placebo 15mg for 12 weeks
798791|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798792|NCT01402284|O1|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798793|NCT01402284|E1|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone|Patients will receive 8 cycles of induction combination therapy of carfilzomib, lenalidomide, and dexamethasone (CRd). Patients achieving stable disease or better after 8 cycles of CRd will receive lenalidomide extended dosing (phase I) for 12 cycles. After 12 cycles, patients will have the option to continue extended dosing (phase II) for one additional year Carfilzomib: Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16 Lenalidomide: Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year Dexamethasone: Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22,
798794|NCT01402141|B3|Baseline|Total|Total of all reporting groups
798795|NCT01402141|B2|Baseline|Placebo(35g)|
798796|NCT01402141|B1|Baseline|Chungkookjang(35g)|
798797|NCT01402141|P2|Participant Flow|Placebo|"Placebo(3times/day, 3packs/day, 35g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Chungkookjang."
798798|NCT01402141|P1|Participant Flow|Chungkookjang|"Chungkookjang(3times/day, 3packs/day, 35g/day) for 12weeks~Chungkookjang: The Chungkookjang was manufactured from raw beans, peels made after freeze-drying"
798799|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
798800|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798801|NCT01402141|O2|Outcome|Placeb|Oral intake placebo(35g/day) for 12weeks
798802|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798803|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
798804|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798805|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
798806|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798807|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
798808|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798809|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
798810|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798811|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
798812|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798813|NCT01402141|O2|Outcome|Placebo|Oral intake placebo(35g/day) for 12weeks
798814|NCT01402141|O1|Outcome|Chungkookjang|Oral intake Chungkookjang(35g) for 12weeks.
798815|NCT01402141|E2|Reported Event|Placebo(35g)|Oral intake placebo(35g/day) for 12weeks
798816|NCT01402141|E1|Reported Event|Chungkookjang(35g)|Oral intake Chungkookjang(35g) for 12weeks.
798817|NCT01402128|B3|Baseline|Total|Total of all reporting groups
798818|NCT01402128|B2|Baseline|Placebo|Placebo for 12 weeks
798819|NCT01402128|B1|Baseline|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798820|NCT01402128|P2|Participant Flow|Placebo|"Placebo(1times/day, 1packs/day, 3g/day) for 12weeks~Placebo : Amount and calorie of placebo are same with Barley beta-glucan"
798821|NCT01402128|P1|Participant Flow|Barley Beta-glucan|"Barley beta-glucan(1times/day, 1packs/day, 3g/day) for 12weeks~Barley beta-glucan: Barley as raw material is milled by crushing the liquefaction and saccharification enzymes reacted after baking yeast (S. cereviasiae) for 48 h, is produced through the fermentation process."
798822|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798823|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798824|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798825|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798826|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798827|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798828|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798829|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798830|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798831|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798832|NCT01402128|O2|Outcome|Placebo|Placebo for 12 weeks
798833|NCT01402128|O1|Outcome|Barley Beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
798872|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798873|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798874|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798875|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798876|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
798877|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
798878|NCT01402102|O2|Outcome|Placebo|Placebo 6.0g/day oral intake
798879|NCT01402102|O1|Outcome|Aged Garlic Powder|Aged garlic powder 6.0g/day oral intake
798880|NCT01402102|O2|Outcome|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798881|NCT01402102|O1|Outcome|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798882|NCT01402102|E2|Reported Event|Placebo|Oral intake placebo(6.0g/day) for 12weeks
798883|NCT01402102|E1|Reported Event|Aged Garlic Powder|Oral intake Aged garlic powder(6.0g/day) for 12weeks.
798884|NCT01402063|B3|Baseline|Total|Total of all reporting groups
798885|NCT01402063|B2|Baseline|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
798886|NCT01402063|B1|Baseline|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
798887|NCT01402063|P2|Participant Flow|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
798888|NCT01402063|P1|Participant Flow|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
798889|NCT01402063|O2|Outcome|Radiation + Temozolomide|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
798890|NCT01402063|O1|Outcome|Radiation Plus PPX(CT2103|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
798891|NCT01402063|E2|Reported Event|Radiation + Temozolomide and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ Daily oral temozolomide(TMZ) (7 days) x 6 wks for a total of 42 days~Temozolomide: XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum"
798892|NCT01402063|E1|Reported Event|Radiation Plus PPX and Maintenance|"Radiation therapy, Monday through Friday, for 6 weeks for a total of 30 treatments~+ intravenous PPX every week x 6 weeks for a total of 6 treatments~PPX (CT2103): XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum."
798893|NCT01401842|B3|Baseline|Total|Total of all reporting groups
798894|NCT01401842|B2|Baseline|Stabilization Exercise|Low intensity core stabilization exercise
798895|NCT01401842|B1|Baseline|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
798896|NCT01401842|P2|Participant Flow|Stabilization Exercise|Low intensity core stabilization exercise
798897|NCT01401842|P1|Participant Flow|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
798898|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
798899|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
798900|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
798901|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
798902|NCT01401842|O2|Outcome|Stabilization Exercise|Low intensity core stabilization exercise
798903|NCT01401842|O1|Outcome|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
798904|NCT01401842|E2|Reported Event|Stabilization Exercise|Low intensity core stabilization exercise
798905|NCT01401842|E1|Reported Event|Strengthening Exercise|Lumbar ext. high intensity progressive resistance exercise
798907|NCT01401647|B3|Baseline|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
799314|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
798908|NCT01401647|B2|Baseline|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
798909|NCT01401647|B1|Baseline|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
798910|NCT01401647|P3|Participant Flow|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
798911|NCT01401647|P2|Participant Flow|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
798912|NCT01401647|P1|Participant Flow|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
798913|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
798914|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
798915|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
798916|NCT01401647|O3|Outcome|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
798917|NCT01401647|O2|Outcome|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
798918|NCT01401647|O1|Outcome|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
798919|NCT01401647|E3|Reported Event|Normal Saline|"IV or IO administration of normal saline if VF/pulseless VT reoccurs after initial defibrillation.~Normal saline: 6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists."
798942|NCT01401582|O1|Outcome|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
798920|NCT01401647|E2|Reported Event|Lidocaine|"IV or IO administration of lidocaine if VF/pulseless VT reoccurs after initial defibrillation.~Lidocaine: 120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists."
798921|NCT01401647|E1|Reported Event|Amiodarone|"Intravenous (IV) or intraosseous (IO) administration of amiodarone if VF/pulseless VT reoccurs after initial defibrillation.~amiodarone: 300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists."
798922|NCT01401595|B3|Baseline|Total|Total of all reporting groups
798923|NCT01401595|B2|Baseline|Control Subjects|10 control participants completed the baseline screening and SPECT scans.
798924|NCT01401595|B1|Baseline|Night Eaters|31 participants screened and diagnosed with NES attended the baseline treatment session and at least one follow-up appointment.
798925|NCT01401595|P2|Participant Flow|Control Subjects|"At the beginning of the study, control subjects were given a medical history, height and weight was measured, and BMI calculated. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing.~An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding of the 10 control subjects with that of the 30 night eating subjects to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls."
798926|NCT01401595|P1|Participant Flow|Night Eaters|"Subjects were given a medical history, and height and weight was measured. Initial outpatient assessment included diary measurement of food intake and nighttime awakenings (and associated food intake) together with psychological testing. For women, a pregnancy test was also administered no more than 48 hours before SPECT-CT imaging and the beginning of Lexapro treatment. Lexapro treatment lasted 12 weeks.~escitalopram oxalate: The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding was conducted which will compare SERT binding in 30 night eaters with that of 10 controls. The first procedure assessed SPECT-CT images of night eaters and controls. Medication was administered starting at 10 mg daily, with increases up to 20 mg, as indicated and tolerated, for up to three months. Visits occured at baseline and weeks 1, 2, 4, 6, 8, 10, and 12."
798927|NCT01401595|O2|Outcome|Controls|The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
798928|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All NES subjects received the open label escitalopram treatment
798929|NCT01401595|O2|Outcome|Controls|The controls did not participate in the escitalopram treatment portion of the study. The just completed the baseline screening and SPECT scan.
798930|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All NES subjects received the open label escitalopram treatment
798931|NCT01401595|O2|Outcome|Controls|The control participants did not participate in the treatment part of the study - only the baseline SPECT scans.
798932|NCT01401595|O1|Outcome|Night Eating Syndrome Open Label Escitalopram Treatment|All subjects with NES participated in the open label treatment with escitalopram, although of the 32 participants, 1 did not return after her initial medication visit. As it is unknown if this participants started the medication, only the 31 participants who returned to a second visit or more were included in the analysis
798933|NCT01401595|E1|Reported Event|Night Eating Syndrome Open Label Treatment Group|Only the 32 participants with NES participated in the open label escitalopram treatment trial. One participant did not return after the first visit, and it is unknown if she ever started the medication. Thus 31 participants were included in the statistical analyses.
798934|NCT01401582|B3|Baseline|Total|Total of all reporting groups
798935|NCT01401582|B2|Baseline|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
798936|NCT01401582|B1|Baseline|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
798937|NCT01401582|P2|Participant Flow|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
798938|NCT01401582|P1|Participant Flow|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
798939|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
798940|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
798941|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
798943|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
798944|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
798945|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers.~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
798946|NCT01401582|O1|Outcome|Care as Usual|"care as usual, no intervention, just observation of natural change/ trajectories over time~published in Thyrian et al. (2016). Journal of Alzheimer´s Disease (52); 69-617."
798947|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
798948|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
798949|NCT01401582|O2|Outcome|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Implementation of Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
798950|NCT01401582|O1|Outcome|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
798951|NCT01401582|E2|Reported Event|Implementation of Dementia Care Manager|"Subjects in this arm will be provided with a specialised Dementia Care Manager to be included in a subsidiary support system~Provision of a Dementia Care Manager: Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
798952|NCT01401582|E1|Reported Event|Care as Usual|care as usual, no intervention, just observation of natural change/ trajectories over time
798953|NCT01401517|B4|Baseline|Total|Total of all reporting groups
798954|NCT01401517|B3|Baseline|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798955|NCT01401517|B2|Baseline|40 mg Sodium Nitrite|"40 mg dose, BID~40 mg sodium nitrite: 40 twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798956|NCT01401517|B1|Baseline|Placebo|Placebo twice each day for 11 weeks
798957|NCT01401517|P3|Participant Flow|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798958|NCT01401517|P2|Participant Flow|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798959|NCT01401517|P1|Participant Flow|Placebo|sodium nitrite: 0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.
798960|NCT01401517|O3|Outcome|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite:80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798961|NCT01401517|O2|Outcome|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798962|NCT01401517|O1|Outcome|Placebo|0 mg twice each day for 11 weeks.
798963|NCT01401517|E3|Reported Event|80 mg Sodium Nitrite|"80 mg dose, BID~sodium nitrite: 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798964|NCT01401517|E2|Reported Event|40 mg Sodium Nitrite|"40 mg dose, BID~sodium nitrite: 40 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose."
798965|NCT01401517|E1|Reported Event|Placebo|sodium nitrite: 0 mg twice each day for 11 weeks .
798966|NCT01401478|B1|Baseline|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798967|NCT01401478|P1|Participant Flow|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798968|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798969|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798970|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798971|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798972|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798973|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798974|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798975|NCT01401478|O1|Outcome|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798976|NCT01401478|E1|Reported Event|Stage 5 Chronic Kidney Disease|Planned for Zemplar administration due to secondary hyperparathyroidism
798977|NCT01401465|B3|Baseline|Total|Total of all reporting groups
798978|NCT01401465|B2|Baseline|Sequence MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
800372|NCT01396226|P2|Participant Flow|PLACEBO|Placebo solution for infusion
798979|NCT01401465|B1|Baseline|Sequence CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
798980|NCT01401465|P2|Participant Flow|MOM / CIC|Sequence MOM/CIC: Treatment Period 1 = mometasone nasal inhalation 200 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = ciclesonide Nasal aerosol 74 mcg once daily for two weeks
798981|NCT01401465|P1|Participant Flow|CIC / MOM|Sequence CIC/MOM: Treatment Period 1 = ciclesonide nasal aerosol 74 mcg once daily for two weeks; followed by a 2-week washout phase between treatments; next Treatment Period 2 = mometasone nasal inhalation 200 mcg once daily for two weeks
798982|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
798983|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
798984|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
798985|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
798986|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
798987|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
798988|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
798989|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
798990|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
798991|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
798992|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
798993|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
798994|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg once daily
798995|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg once daily
798996|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
798997|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
798998|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
798999|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799000|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799001|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799002|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799003|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799004|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799005|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799006|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799007|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799008|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799009|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799010|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799011|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799012|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799013|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799014|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799015|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799016|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799017|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799018|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799019|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799020|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799021|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799022|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799023|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799024|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799025|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799026|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799027|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799028|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799029|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799030|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799031|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799032|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799033|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799034|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799035|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799036|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799037|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799038|NCT01401465|O2|Outcome|Mometasone|Mometasone AQ 200 mcg
799039|NCT01401465|O1|Outcome|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799040|NCT01401465|O1|Outcome|Ciclesonide Versus Mometasone|This analysis presents the comparison of ciclesonide versus mometasone and provides the score in relation to the preference for ciclesonide
799041|NCT01401465|E2|Reported Event|Mometasone|Mometasone AQ 200 mcg
799042|NCT01401465|E1|Reported Event|Ciclesonide|Ciclesonide nasal aerosol 74 mcg
799043|NCT01401361|B1|Baseline|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
799044|NCT01401361|P1|Participant Flow|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
799079|NCT01401257|E2|Reported Event|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799045|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
799315|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799046|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
799047|NCT01401361|O1|Outcome|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
799048|NCT01401361|E1|Reported Event|Treatment Arm|Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
799049|NCT01401322|B1|Baseline|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
799050|NCT01401322|P1|Participant Flow|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
799051|NCT01401322|O1|Outcome|Lenalidomide 50 mg/Day x 28 Days|"Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.~Lenalidomide: 50 mg; po"
799052|NCT01401322|E1|Reported Event|Lenalidomide 50 mg/Day x 28 Days|Lenalidomide 50 mg daily for 28 consecutive days every 42 days (+/-7 days). Treatment to continue until evidence of disease progression or development of unexpected toxicities not reversed by dose reductions and/or interruptions.
799053|NCT01401283|B3|Baseline|Total|Total of all reporting groups
799054|NCT01401283|B2|Baseline|Control Group|hemodynamic management according to institutional clinical standards
799055|NCT01401283|B1|Baseline|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
799056|NCT01401283|P2|Participant Flow|Control Group|hemodynamic management according to institutional clinical standards
799057|NCT01401283|P1|Participant Flow|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
799058|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
799059|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
799060|NCT01401283|O2|Outcome|Control Group|hemodynamic management according to institutional clinical standards
799061|NCT01401283|O1|Outcome|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
799062|NCT01401283|E2|Reported Event|Control Group|hemodynamic management according to institutional clinical standards
799063|NCT01401283|E1|Reported Event|Study Group|"intraoperative guidance of hemodynamics by measures of cardiac index and pulse pressure variation~measurement of cardiac output and pulse pressure variation: hemodynamic optimization according to cardiac index and pulse pressure variation"
799064|NCT01401257|B5|Baseline|Total|Total of all reporting groups
799065|NCT01401257|B4|Baseline|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
799066|NCT01401257|B3|Baseline|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799067|NCT01401257|B2|Baseline|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799068|NCT01401257|B1|Baseline|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799069|NCT01401257|P4|Participant Flow|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
799070|NCT01401257|P3|Participant Flow|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799071|NCT01401257|P2|Participant Flow|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799072|NCT01401257|P1|Participant Flow|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799073|NCT01401257|O4|Outcome|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
799074|NCT01401257|O3|Outcome|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799075|NCT01401257|O2|Outcome|PXT3003 Intermediate Dose|"Oral Liquid formulation, 1/50, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799076|NCT01401257|O1|Outcome|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799077|NCT01401257|E4|Reported Event|Placebo|"Oral Liquid formulation, bid, 12 months~Placebo: Liquid,5 ml, twice a day, 12-month treatment"
799078|NCT01401257|E3|Reported Event|PXT3003 High Dose|"Oral Liquid formulation, 1/10, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799080|NCT01401257|E1|Reported Event|PXT3003 Low Dose|"Oral Liquid formulation, 1/100, bid, 12 months~PXT3003: Liquid,5 ml, twice a day, 12-month treatment"
799081|NCT01401166|B3|Baseline|Total|Total of all reporting groups
799650|NCT01399190|B1|Baseline|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
799082|NCT01401166|B2|Baseline|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799083|NCT01401166|B1|Baseline|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799084|NCT01401166|P4|Participant Flow|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799085|NCT01401166|P3|Participant Flow|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799086|NCT01401166|P2|Participant Flow|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799087|NCT01401166|P1|Participant Flow|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via single-use injection device (SID), and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by healthcare professional (HCP). Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 milligrams (mg) for all cycles where SC Herceptin was given, and the IV dose was 6 milligrams per kilogram (mg/kg) for all cycles where IV Herceptin was given.
799088|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799089|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799099|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799316|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799090|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799091|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799092|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799093|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799094|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799095|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799096|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799097|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799098|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799142|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799143|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water) o
799144|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799145|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799146|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799147|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799100|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799101|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799102|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799103|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799104|NCT01401166|O1|Outcome|All HCPs: SC and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
799105|NCT01401166|O1|Outcome|All HCPs: SC and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID (Cohort 1) or vial (Cohort 2) for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin (Cohort 1) or SC Herceptin (Cohort 2) for up to 10 remaining cycles. Participants in Cohort 1 with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered to self-administer SC Herceptin via SID under the direction of a trained HCP, whereas in Cohort 2, administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for both SID and vial.
799106|NCT01401166|O4|Outcome|Cohort 2: IV Then SC (Vial) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via handheld syringe using the vial formulation. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799107|NCT01401166|O3|Outcome|Cohort 2: SC (Vial) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via handheld syringe using the vial formulation, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP throughout the study. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799108|NCT01401166|O2|Outcome|Cohort 1: IV Then SC (SID) Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, IV Herceptin was given, and during Cycles 5 to 8, SC Herceptin was administered via SID. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The IV dose was a loading dose of 8 mg/kg in Cycle 1 for de novo participants who started Herceptin treatment in the study, and a dose of 6 mg/kg for all subsequent cycles where IV Herceptin was given and for non-de novo participants. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799148|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799109|NCT01401166|O1|Outcome|Cohort 1: SC (SID) Then IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. During Cycles 1 to 4 of the crossover period, SC Herceptin was administered via SID, and during Cycles 5 to 8, IV Herceptin was given. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. The SC dose was 600 mg for all cycles where SC Herceptin was given, and the IV dose was 6 mg/kg for all cycles where IV Herceptin was given.
799110|NCT01401166|E10|Reported Event|Cohort 2 Overall: SC (Vial) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via handheld syringe using the vial formulation for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received SC Herceptin for up to 10 remaining cycles. Administration was performed by HCP throughout the study. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799111|NCT01401166|E9|Reported Event|Cohort 2: SC (Vial) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. Administration was performed by HCP.
799112|NCT01401166|E8|Reported Event|Cohort 2: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants were planned to receive SC Herceptin via handheld syringe using the vial formulation for up to 10 remaining cycles. However, under protocol deviation a small number of participants received IV Herceptin as a 6-mg/kg dose for this period. Administration was performed by HCP.
799113|NCT01401166|E7|Reported Event|Cohort 2: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
799114|NCT01401166|E6|Reported Event|Cohort 2: SC (Vial) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via handheld syringe using the vial formulation as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
799115|NCT01401166|E5|Reported Event|Cohort 1 Overall: SC (SID) and IV Herceptin|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles, randomized to one of two crossover sequences: SC Herceptin via SID for Cycles 1 to 4 followed by IV Herceptin for Cycles 5 to 8, or vice versa. In the continuation period, participants received IV Herceptin for up to 10 remaining cycles. Administration was performed by HCP. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID under the direction of a trained HCP. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg for de novo participants who started Herceptin treatment in the study. For all other cycles where IV Herceptin was given and for non-de novo participants, the dose was 6 mg/kg. The SC dose was 600 mg for all cycles where SC Herceptin was given.
799116|NCT01401166|E4|Reported Event|Cohort 1: SC (SID) Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. Those with at least 2 treatment cycles remaining of the 18-cycle treatment course after the crossover period were offered the opportunity to self-administer SC Herceptin via SID as a 600-mg dose under the direction of a trained HCP.
799117|NCT01401166|E3|Reported Event|Cohort 1: IV Herceptin (Continuation)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. In the continuation period, participants received IV Herceptin as a 6-mg/kg dose for up to 10 remaining cycles. Administration was performed by HCP.
799118|NCT01401166|E2|Reported Event|Cohort 1: IV Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. IV Herceptin was given as a 6-mg/kg dose during four consecutive cycles of the crossover period. If study treatment for Cycle 1 was IV Herceptin, the initial dose was a loading dose of 8 mg/kg (instead of 6 mg/kg) for de novo participants who started Herceptin treatment in the study. Administration was performed by HCP.
799119|NCT01401166|E1|Reported Event|Cohort 1: SC (SID) Herceptin (Crossover)|Participants received Herceptin on Day 1 of each 3-week cycle for 18 cycles. SC Herceptin was administered via SID as a 600-mg dose during four consecutive cycles of the crossover period. Administration was performed by HCP.
799120|NCT01401153|B3|Baseline|Total|Total of all reporting groups
799121|NCT01401153|B2|Baseline|Skipping Lunch|No lunch (water)
799122|NCT01401153|B1|Baseline|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
799123|NCT01401153|P2|Participant Flow|Skipping Lunch|No lunch (water)
799124|NCT01401153|P1|Participant Flow|Having Lunch|Lunch ad libitum (pasta Bolognese, apple and water)
799125|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799126|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799127|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799128|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799129|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799130|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799131|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799132|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799133|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799134|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799135|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799136|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799137|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799138|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799139|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799140|NCT01401153|O1|Outcome|Having Lunch|Lunch ad libitum
799141|NCT01401153|O2|Outcome|Skipping Lunch|No lunch (water)
799156|NCT01401101|B2|Baseline|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
799157|NCT01401101|B1|Baseline|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
799158|NCT01401101|P2|Participant Flow|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
799159|NCT01401101|P1|Participant Flow|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
799160|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
799161|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
799162|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
799163|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
799164|NCT01401101|O2|Outcome|Treatment-as-Usual (TAU)|"The TAU condition will consist of only the clinician education and patient screening without written feedback.~Treatment-as-Usual: The TAU condition will consist of only the clinician education and patient screening without written feedback."
799165|NCT01401101|O1|Outcome|PTSD Care Management (PCM)|"There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.~quality improvement: Care Manager (CM) intervention"
799166|NCT01401101|E2|Reported Event|Treatment-as-Usual (TAU)|The TAU condition consists of only the clinician education and patient screening without written feedback.
799167|NCT01401101|E1|Reported Event|PTSD Care Management (PCM)|There are six PCM intervention components: 1) patient education, 2) patient screening and written feedback of screening information to primary care clinicians, 3) clinician education on practice guidelines , 4) structured feedback between primary care and mental health clinicians, 5) continuity of patient care, and 6) a resource guide detailing available community services where the CHC has established reciprocal referrals. All of the intervention components will be implemented through the CM, except for the clinician education component, which will combine onsite and online continuing medical education (CME)-accredited sessions.
799168|NCT01401062|B3|Baseline|Total|Total of all reporting groups
799169|NCT01401062|B2|Baseline|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799170|NCT01401062|B1|Baseline|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799171|NCT01401062|P2|Participant Flow|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799172|NCT01401062|P1|Participant Flow|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799646|NCT01399229|P2|Participant Flow|Pregnant, Preterm, Non Labor|Pregnant preterm women independently determined to not be in labor.
799173|NCT01401062|O2|Outcome|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799174|NCT01401062|O1|Outcome|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799175|NCT01401062|E2|Reported Event|Arm 2 (Fresolimumab 10 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 10 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799176|NCT01401062|E1|Reported Event|Arm 1 (Fresolimumab 1 mg/kg)|"Fresolimumab is administered intravenously (i.v.) at a dose of 1 mg/kg on day 1 of weeks 0, 3, 6, 9 & 12 and radiation administered at 7.5 Gy/fraction in 3 fractions during weeks 1 (to lesion 1) and 7 (to lesion 2).~Fresolimumab~Radiation Therapy"
799177|NCT01401049|B3|Baseline|Total|Total of all reporting groups
799178|NCT01401049|B2|Baseline|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
799179|NCT01401049|B1|Baseline|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
799180|NCT01401049|P2|Participant Flow|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
799181|NCT01401049|P1|Participant Flow|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
799182|NCT01401049|O2|Outcome|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
799183|NCT01401049|O1|Outcome|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
799184|NCT01401049|E2|Reported Event|Propofol/Lidocaine|"The purpose of this study is to compare the incidence and intensity of possible pain on injection as well as patient satisfaction caused by propofol (a lipid based medication); Lusedra (a water based medication); and the drug combination of propofol with lidocaine (a local anesthetic commonly used with propofol injection).~Propofol/Lidocaine: We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion)."
799185|NCT01401049|E1|Reported Event|Fospropofol|"To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.~Fospropofol: To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control."
799186|NCT01401023|B1|Baseline|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
799187|NCT01401023|P1|Participant Flow|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
799188|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
799189|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
799190|NCT01401023|O1|Outcome|Clostridium Difficile Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
799191|NCT01401023|E1|Reported Event|CDAD Patient|"Open non-comparative trial~Tygacil : : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 mg LD followed by 50 mg Q12h) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy."
799192|NCT01401010|B3|Baseline|Total|Total of all reporting groups
799193|NCT01401010|B2|Baseline|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
799194|NCT01401010|B1|Baseline|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
799195|NCT01401010|P2|Participant Flow|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
799196|NCT01401010|P1|Participant Flow|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
799197|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
799198|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
799199|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
799200|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
799201|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
799202|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
799203|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
799204|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
799205|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
799206|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
799207|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
799208|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
799209|NCT01401010|O4|Outcome|1000 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
799210|NCT01401010|O3|Outcome|1000 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
799211|NCT01401010|O2|Outcome|500 mg Doripenem 4 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
799212|NCT01401010|O1|Outcome|500 mg Doripenem 1 Hour Infusion|Probability of target attainment (40%fT>MIC) against Gram-negative pathogens using Monte Carlo simulations
799213|NCT01401010|O3|Outcome|Combined Results for Both 500 and 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Combined Results
799214|NCT01401010|O2|Outcome|Doripenem 1000 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 1000 mg Dosing
799215|NCT01401010|O1|Outcome|Doripenem 500 mg|Mean (SD) Doripenem Pharmacokinetic (PK) Parameters in Febrile Neutropenic Patients Who Received 500mg Dosing
799216|NCT01401010|E2|Reported Event|Doripenem 1000 mg|pharmacokinetics/pharmacodynamics
799217|NCT01401010|E1|Reported Event|Doripenem 500 mg|pharmacokinetics/pharmacodynamics
799218|NCT01400958|B3|Baseline|Total|Total of all reporting groups
799219|NCT01400958|B2|Baseline|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799220|NCT01400958|B1|Baseline|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799221|NCT01400958|P2|Participant Flow|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799222|NCT01400958|P1|Participant Flow|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799313|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799223|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799224|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799225|NCT01400958|O2|Outcome|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799226|NCT01400958|O1|Outcome|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799227|NCT01400958|E2|Reported Event|Placebo Comparator: B: Placebo|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent EBRT and TMZ, there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799228|NCT01400958|E1|Reported Event|Active Comparator: A: Nuvigil®|Study evaluation times correspond to standard follow-up evaluations for newly diagnosed malignant glioma patients. After 6 weeks of concurrent External Beam Radiation Therapy (EBRT) and Temozolomide (TMZ), there is typically a 4 week treatment break prior to the start of the 6 monthly cycles of TMZ. No further placebo or Nuvigil® will be given after the 6 week treatment regimen. Thus, study evaluations will occur at baseline (Week 0), immediately after completion of EBRT, TMZ, and Nuvigil® or placebo (Week 7), at the end of the 4 week washout period (Week 10), after the first 2 cycles of TMZ (Week 18), and after the 6th cycle of TMZ (Week 34).
799229|NCT01400932|B3|Baseline|Total|Total of all reporting groups
799230|NCT01400932|B2|Baseline|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799231|NCT01400932|B1|Baseline|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799232|NCT01400932|P2|Participant Flow|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799233|NCT01400932|P1|Participant Flow|GI148512|Participants applied 2 finger tip units (FTU) of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799234|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799235|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799236|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799237|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799238|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799239|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799240|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799241|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799500|NCT01399866|P1|Participant Flow|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
799242|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799243|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799244|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799245|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799246|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799247|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799248|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799249|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799250|NCT01400932|O2|Outcome|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799251|NCT01400932|O1|Outcome|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799252|NCT01400932|E2|Reported Event|Vehicle Gel|Participants applied 2 FTU of matching vehicle gel of GI148512 without the active ingredient topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799253|NCT01400932|E1|Reported Event|GI148512|Participants applied 2 FTU of GI148512 topically once daily in the evening/bedtime, over the entire face (including the forehead, nose, cheeks, and chin), for a treatment period of 12 weeks.
799254|NCT01400919|B1|Baseline|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
799255|NCT01400919|P1|Participant Flow|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
799256|NCT01400919|O1|Outcome|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
799257|NCT01400919|E1|Reported Event|Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems|"The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.~Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery."
799258|NCT01400906|B1|Baseline|Placebo, FP 100 µg, and FP 500 µg in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods, one inhalation in the morning and evening from Day 1 to 6 and one inhalation on the morning on Day 7, from the Dry Powder Inhaler (DPI): Placebo; Fluticasone propionate (FP) 100 micrograms (µg); and FP 500 µg. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FP 100 µg, FP 500 µg; (2) Placebo, FP 500 µg, FP 100 µg; (3) FP 100 µg, Placebo, FP 500 µg; (4) FP 100 µg, FP 500 µg, Placebo; (5) FP 500 µg, Placebo, FP 100 µg; (6) FP 500 µg, FP 100 µg, Placebo. The three treatment periods were separated by a washout period of 14 days.
799259|NCT01400906|P6|Participant Flow|Sequence 6: FP 500 µg, FP 100 µg, Placebo|Participants received FP 500 µg, FP 100 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
799260|NCT01400906|P5|Participant Flow|Sequence 5: FP 500 µg, Placebo, FP 100 µg|Participants received FP 500 µg, Placebo, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
799261|NCT01400906|P4|Participant Flow|Sequence 4: FP 100 µg, FP 500 µg, Placebo|Participants received FP 100 µg, FP 500 µg, and Placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
799501|NCT01399866|O2|Outcome|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
799262|NCT01400906|P3|Participant Flow|Sequence 3: FP 100 µg, Placebo, FP 500 µg|Participants received FP 100 µg, Placebo, and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
799263|NCT01400906|P2|Participant Flow|Sequence 2: Placebo, FP 500 µg, FP 100 µg|Participants received Placebo, FP 500 µg, and FP 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the DPI. The three treatment periods were separated by a washout period of 14 days.
799264|NCT01400906|P1|Participant Flow|Sequence 1: Placebo, FP 100 µg, FP 500 µg|Participants received placebo, Fluticasone Propionate (FP) 100 micrograms (µg), and FP 500 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments, one inhalation in the morning and evening from Day 1 to 6 and one inhalation in the morning on Day 7, from the Dry Powder Inhaler (DPI). The three treatment periods were separated by a washout period of 14 days.
799265|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799266|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799267|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799268|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799269|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799270|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799271|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799272|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799273|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799274|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799275|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799276|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799277|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799278|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799279|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799280|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799281|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799282|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799283|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799502|NCT01399866|O1|Outcome|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
799284|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799285|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799286|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799287|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799288|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799289|NCT01400906|O3|Outcome|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799290|NCT01400906|O2|Outcome|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799291|NCT01400906|O1|Outcome|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799292|NCT01400906|E3|Reported Event|FP 500 µg|Participants received FP 500 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799293|NCT01400906|E2|Reported Event|FP 100 µg|Participants received FP 100 µg, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799294|NCT01400906|E1|Reported Event|Placebo|Participants received placebo, one inhalation in the morning and one in the evening from Day 1 to 6, and one inhalation in the morning on Day 7 from the DPI during one of the three treatment periods. Each treatment period was followed by a washout period of 14 days.
799295|NCT01400880|B1|Baseline|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
799296|NCT01400880|P1|Participant Flow|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation monitored with Electrode Sensor, TOCO and IUPC
799297|NCT01400880|O1|Outcome|Electrode Sensor, TOCO and IUPC|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation studied with electrode sensor, Tocodynamometer and IUPC
799298|NCT01400880|E1|Reported Event|Primary|Pregnant women between the ages of 18-50 with a single viable fetus in cephalic presentation
799299|NCT01400841|B1|Baseline|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799300|NCT01400841|P1|Participant Flow|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799301|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799302|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799303|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799304|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799305|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799306|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799307|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799308|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799309|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799310|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799311|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799312|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799317|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799318|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799319|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799320|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799321|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799322|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799323|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799324|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799325|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799326|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799327|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799328|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799329|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799330|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799331|NCT01400841|O1|Outcome|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799332|NCT01400841|E1|Reported Event|HAART 300 Annuloplasty Device|"Implantation of HAART 300 Annuloplasty Device for aortic valve repair~HAART 300 Annuloplasty Device: Implantation of device for aortic valve repair"
799333|NCT01400698|B5|Baseline|Total|Total of all reporting groups
799334|NCT01400698|B4|Baseline|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799335|NCT01400698|B3|Baseline|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799336|NCT01400698|B2|Baseline|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799337|NCT01400698|B1|Baseline|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799338|NCT01400698|P6|Participant Flow|Observation (C)|Participants with bone age >12 years for girls or 14 years for boys or refused to be treated in any of the above groups were followed without treatment until they reached final height for a maximum duration of 10.6 years.
799339|NCT01400698|P5|Participant Flow|Observed Then Randomized to Observation (B2)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to observation group with no treatment until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
799340|NCT01400698|P4|Participant Flow|Observed Then Randomized to Saizen® (B1)|Participants with bone age <=12 years for girls or 14 years for boys and height >-2 SD were observed until first signs of puberty and if remained at a height >-2 SD, were randomized to receive continuous treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Participants whose height fell to <=-2 SD before the first sign of puberty, were randomized to either Saizen® Continuous (A1) or Saizen® Intermittent (A2) treatment group.
799341|NCT01400698|P3|Participant Flow|Observed, Not Randomized (B0)|Participants with bone age <=12 years for girls or 14 years for boys and height greater than (>) -2 SD were observed until first signs of puberty but not randomized.
799342|NCT01400698|P2|Participant Flow|Saizen® Intermittent (A2)|Participants with bone age <=12 years for girls or 14 years for boys and height <=-2 SD received intermittent treatment with r-hGH 0.067 mg/kg/day sc until they reached final height for a maximum duration of 10.6 years. Intermittent treatment was given on an individual basis depending on the height achieved during the study.
799503|NCT01399866|E2|Reported Event|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
799343|NCT01400698|P1|Participant Flow|Saizen® Continuous (A1)|Participants with bone age less than or equal to (<=) 12 years for girls or 14 years for boys and height <=-2 standard deviation (SD) received continuous treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc) until they reached final height for a maximum duration of 10.6 years.
799344|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799345|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799346|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799347|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799348|NCT01400698|O2|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799349|NCT01400698|O1|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799350|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799351|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799352|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799353|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799354|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799355|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799356|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799357|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799358|NCT01400698|O4|Outcome|Final Height: Treated|Includes all participants who achieved the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799359|NCT01400698|O3|Outcome|Final Height: Not Treated|Includes all participants who achieved the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799360|NCT01400698|O2|Outcome|Non-Final Height: Treated|Includes all participants who did not achieve the final height during the study period and received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799361|NCT01400698|O1|Outcome|Non-Final Height: Not Treated|Includes all participants who did not achieve the final height during the study period and did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799362|NCT01400698|E2|Reported Event|Treated|Included all participants who received r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799363|NCT01400698|E1|Reported Event|Not Treated|Included all participants who did not receive r-hGH 0.067 mg/kg/day sc either continuously or intermittently.
799364|NCT01400516|B3|Baseline|Total|Total of all reporting groups
799365|NCT01400516|B2|Baseline|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
799366|NCT01400516|B1|Baseline|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
799367|NCT01400516|P2|Participant Flow|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
799368|NCT01400516|P1|Participant Flow|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
799369|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
799370|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
799504|NCT01399866|E1|Reported Event|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
799371|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
799516|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799372|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
799373|NCT01400516|O2|Outcome|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
799374|NCT01400516|O1|Outcome|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
799375|NCT01400516|E2|Reported Event|Teriparatide|The participants who are in treatment arm received teriparatide 20 μg, subcutaneous injection, 1 injection per day, with a biologic for 12 months. A second year of teriparatide was offered to all interested participants. All participants received daily 1000 milligrams (mg) of calcium citrate, 800 IU of vitamin D and a Tumor Necrosis Factor (TNF) antagonist.
799376|NCT01400516|E1|Reported Event|Control Arm|The participants randomized to the control arm had the same testing as those in the treatment arm and were offered teriparatide, if determined to be effective in healing bone erosions, after the first 12 months. All participants received daily 1000 mg of calcium citrate, 800 IU of vitamin D and a TNF antagonist.
799377|NCT01400451|B4|Baseline|Total|Total of all reporting groups
799378|NCT01400451|B3|Baseline|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
799379|NCT01400451|B2|Baseline|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
799380|NCT01400451|B1|Baseline|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1, plus 960 mg vemurafenib orally twice daily throughout combination treatment."
799381|NCT01400451|P3|Participant Flow|720 mg Vemurafenib|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the dose limiting toxicities (DLTs) were identified ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily. Note: the dose of vemurafenib could be escalated from 720 mg to 960 mg, at the investigator’s discretion.
799382|NCT01400451|P2|Participant Flow|3 mg/kg Ipilimumab + 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily throughout combination treatment."
799383|NCT01400451|P1|Participant Flow|3 mg/kg Ipilimumab + 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Combination Treatment (Induction of ipilimumab) Period: 3 milligrams per kilogram body weight (mg/kg) ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily throughout combination treatment."
799384|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
799385|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily continuing during combination treatment.
799386|NCT01400451|O2|Outcome|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
799387|NCT01400451|O1|Outcome|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
799388|NCT01400451|O3|Outcome|720 mg Vemurafenib Alone|"These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.~Events from first day of vemurafenib to last day of treatment + 90 days, up to date of data cut off for Primary Endpoint."
799389|NCT01400451|O2|Outcome|720 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
799390|NCT01400451|O1|Outcome|960 mg Vemurafenib Lead in Period|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
799391|NCT01400451|E5|Reported Event|3 mg/kg Ipilimumab + 720 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 720 mg vemurafenib orally twice daily continuing during combination treatment.
799505|NCT01399788|B1|Baseline|Entire Study Population|Includes participants randomized to receive Myrin-P Forte first and four single drug references first.
799392|NCT01400451|E4|Reported Event|3 mg/kg Ipilimumab + 960 mg Vemurafenib|3 mg/kg ipilimumab intravenously once every 3 weeks for 4 weeks (Week 1, Week 4, Week 7, Week 10) starting on Day 1 plus 960 mg vemurafenib orally twice daily and continuing during combination treatment.
799718|NCT01398852|E1|Reported Event|CXL Treatment|All eyes to be treated with riboflavin and UV light
799393|NCT01400451|E3|Reported Event|Lead- In Period 720 mg Vemurafenib Alone|These participants were receiving 720 mg vemurafenib in the Lead in Period prior to starting ipilimumab but after the DLTs were identified, ipilimumab was not started. Due to disease stabilization, they continued on 720 mg vemurafenib alone orally twice daily.
799394|NCT01400451|E2|Reported Event|Lead-In Period 720 mg Vemurafenib|"Lead In Period: 28 Days of 720 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
799395|NCT01400451|E1|Reported Event|Lead-In Period 960 mg Vemurafenib|"Lead In Period: 28 Days of 960 mg vemurafenib orally twice daily (starting Day -27 or -13).~Events between the first vemurafenib dose and the day prior to the first ipilimumab dose."
799396|NCT01400425|B1|Baseline|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799397|NCT01400425|P1|Participant Flow|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799398|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799399|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799400|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799401|NCT01400425|O3|Outcome|Subjects With a Negative Scan|Subjects with progressive cognitive decline that received a negative scan.
799402|NCT01400425|O2|Outcome|Subjectss With a Positive Scan|Subjects with progressive cognitive decline that received a positive florbetapir scan.
799403|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799404|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799405|NCT01400425|O1|Outcome|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799406|NCT01400425|E1|Reported Event|Subjects With Progressive Cognitive Decline|Subjects who have previously or are currently being evaluated for progressive cognitive decline. Enrolling physicians must have a confidence of less than 85% in their initial diagnosis of the subject's progressive cognitive decline and that there was at least a 15% chance that the subject's progressive cognitive decline was due to Alzheimer's disease. All subjects who did not complete the study withdrew before receiving a florbetapir F 18 injection and PET scan. Subjects received IV injection, 370 MBq (10 mCi) florbetapir F18, single dose.
799407|NCT01400412|B3|Baseline|Total|Total of all reporting groups
799506|NCT01399788|P2|Participant Flow|Four Single Drug References First, Then Myrin-P Forte|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in first intervention period; and single oral dose of 4 FDC tablets of Myrin-P Forte (each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in second intervention period. A washout period of at least 1 week was maintained between each period.
799517|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799408|NCT01400412|B2|Baseline|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799409|NCT01400412|B1|Baseline|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799410|NCT01400412|P2|Participant Flow|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799411|NCT01400412|P1|Participant Flow|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799412|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799413|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799414|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799415|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799416|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799507|NCT01399788|P1|Participant Flow|Myrin-P Forte First, Then Four Single Drug References|Single oral dose of 4 fixed dose combination (FDC) tablets of Myrin-P Forte (each tablet contains 150 milligram (mg) rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide) in first intervention period; and single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in second intervention period. A washout period of at least 1 week was maintained between each period.
799417|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799418|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799419|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799420|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799421|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799422|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799423|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799424|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799425|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799508|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799509|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799644|NCT01399229|B1|Baseline|Pregnant|The study focused on recruiting laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients.
799426|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799427|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799428|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799429|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799430|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799431|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799432|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799433|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799434|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799510|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799511|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799649|NCT01399229|E1|Reported Event|Pregnant|
799435|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799436|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799437|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799438|NCT01400412|O2|Outcome|TDF Arm: DRV/r + TDF + FTC + MVC Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one tablet."
799439|NCT01400412|O1|Outcome|MVC Arm: DRV/r + MVC + FTC + TDF Placebo|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.~Maraviroc: Maraviroc was administered orally once a day as one 150 mg tablet."
799440|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799441|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799442|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799443|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799512|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799513|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799696|NCT01399008|O1|Outcome|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
799444|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799445|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799446|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799447|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799448|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799449|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799450|NCT01400412|O2|Outcome|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799451|NCT01400412|O1|Outcome|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799452|NCT01400412|E2|Reported Event|TDF Arm (DRV/r + TDF + FTC + MVC Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Emtricitabine 200 mg PO QD + Tenofovir disoproxil fumarate 300 mg PO QD + Placebo for Maraviroc PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Tenofovir disoproxil fumarate: Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Maraviroc: Placebo for maraviroc was administered orally once a day as one 150 mg tablet."
799514|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799515|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799719|NCT01398839|B3|Baseline|Total|Total of all reporting groups
799453|NCT01400412|E1|Reported Event|MVC Arm (DRV/r + MVC + FTC + TDF Placebo)|"Darunavir 800 mg PO QD + Ritonavir 100 mg PO QD + Maraviroc 150 mg PO QD + Emtricitabine 200 mg PO QD + Placebo for Tenofovir disoproxil fumarate PO QD~Darunavir: Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.~Ritonavir: Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.~Emtricitabine: Emtricitabine was administered orally once a day as one 200 mg capsule.~Placebo for Tenofovir disoproxil fumarate: Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet."
799454|NCT01400243|B3|Baseline|Total|Total of all reporting groups
799455|NCT01400243|B2|Baseline|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799456|NCT01400243|B1|Baseline|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799457|NCT01400243|P2|Participant Flow|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799458|NCT01400243|P1|Participant Flow|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799459|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799460|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799461|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799462|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799463|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799464|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799465|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799466|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799467|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799468|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799469|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799470|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799471|NCT01400243|O2|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799472|NCT01400243|O1|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799473|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799474|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799475|NCT01400243|O2|Outcome|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799476|NCT01400243|O1|Outcome|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799477|NCT01400243|E2|Reported Event|Placebo Patch|"Placebo patch for 15-day quit period~Placebo Patch: Placebo patch"
799478|NCT01400243|E1|Reported Event|Nicotine Patch|"7 mg Habitrol nicotine patch-15 day quit period~Nicotine: Nicotine patch 7mg"
799479|NCT01400139|B1|Baseline|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799480|NCT01400139|P1|Participant Flow|Hydrocodone Bitartrate (HYD)|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799481|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799482|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799483|NCT01400139|O2|Outcome|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799484|NCT01400139|O1|Outcome|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799485|NCT01400139|E2|Reported Event|HYD Extension Period|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799486|NCT01400139|E1|Reported Event|HYD Core Study|"Hydrocodone bitartrate (HYD) once daily (q24h) tablets~Hydrocodone bitartrate q24h film-coated tablets: Hydrocodone bitartrate q24h film-coated tablets 20 – 120 mg once daily"
799487|NCT01400113|B3|Baseline|Total|Total of all reporting groups
799488|NCT01400113|B2|Baseline|Placebo|60 patients were randomized to this group
799489|NCT01400113|B1|Baseline|Asenapine|60 patients were randomized to this group
799490|NCT01400113|P2|Participant Flow|Placebo|60 patients were randomized to this group
799491|NCT01400113|P1|Participant Flow|Asenapine|60 patients were randomized to this group
799492|NCT01400113|O2|Outcome|Placebo|60 patients were randomized to this group
799493|NCT01400113|O1|Outcome|Asenapine|60 patients were randomized to this group
799494|NCT01400113|E2|Reported Event|Placebo|Placebo: Placebo Sublingual Tablet, single-dose
799495|NCT01400113|E1|Reported Event|Asenapine|Asenapine: Asenapine Sublingual Tablet 10mg, single-dose
799496|NCT01399866|B3|Baseline|Total|Total of all reporting groups
799497|NCT01399866|B2|Baseline|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
799498|NCT01399866|B1|Baseline|Placebo|"50 mg capsule,single dose, twice, one week apart, by mouth~Placebo"
799499|NCT01399866|P2|Participant Flow|D-cycloserine|"50 mg capsule,single dose, twice, one week apart, by mouth~D-cycloserine: 2 single weekly doses, 50 mg capsule"
799518|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799519|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799520|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799521|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799522|NCT01399788|O2|Outcome|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799523|NCT01399788|O1|Outcome|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799524|NCT01399788|E2|Reported Event|Four Single Drug References|Single oral dose of 4 reference products: 600 mg rifampicin capsules, 300 mg isoniazid, 1100 mg ethambutol and 1500 mg pyrazinamide tablets in either first intervention period or second intervention period.
799525|NCT01399788|E1|Reported Event|Myrin-P Forte|Single oral dose of 4 FDC tablets of Myrin-P Forte (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 275 mg ethambutol and 400 mg pyrazinamide.
799526|NCT01399723|B3|Baseline|Total|Total of all reporting groups
799527|NCT01399723|B2|Baseline|Penicillin|Benzyl penicillin 50000 IU 6 hourly
799528|NCT01399723|B1|Baseline|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
799529|NCT01399723|P2|Participant Flow|Benzyl Penicillin 50,000IU/kg 6 Hourly|Benzyl penicillin: Intravenous 50,000IU/kg 6 hourly
799530|NCT01399723|P1|Participant Flow|Amoxicillin 45mg/kg 12 Hourly|Amoxicillin: Oral 45mg/kg 12 hourly
799531|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
799532|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
799533|NCT01399723|O2|Outcome|Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
799534|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
799535|NCT01399723|O2|Outcome|Penicillin|Benzyl penicillin 50000 IU/kg 6 hourly
799536|NCT01399723|O1|Outcome|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
799537|NCT01399723|E2|Reported Event|Benzyl Penicillin|Benzyl Penicillin 50,000IU/kg 6 hourly
799538|NCT01399723|E1|Reported Event|Amoxicillin|Amoxicillin 45mg/kg 12 hourly
799539|NCT01399697|B4|Baseline|Total|Total of all reporting groups
799540|NCT01399697|B3|Baseline|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
799541|NCT01399697|B2|Baseline|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
799542|NCT01399697|B1|Baseline|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
799543|NCT01399697|P3|Participant Flow|TCZ + Placebo (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was defined) weekly, from Weeks 1 through 16 followed by matching placebo capsules, orally, weekly through Week 24.
799544|NCT01399697|P2|Participant Flow|TCZ + MTX (Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week, but no maximum dose was defined), weekly, from Weeks 1 through 24.
799545|NCT01399697|P1|Participant Flow|Tocilizumab (TCZ) Plus (+) Methotrexate (Not Randomized)|Participants received TCZ 8 milligrams per kilogram (mg/kg; maximum 800 mg) via intravenous (IV) infusion every 4 weeks (q4w) through Week 24 (total of 7 infusions). Participants also received methotrexate (MTX) capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
799546|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799547|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799548|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799549|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799645|NCT01399229|P3|Participant Flow|Pregnant, Term, Non Labor|Pregnant term women independently determined to be in labor.
799550|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799551|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799831|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799552|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799553|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799554|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799555|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799556|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799557|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799558|NCT01399697|O2|Outcome|Tocilizumab + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799559|NCT01399697|O1|Outcome|Tocilizumab + Methotrexate (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799560|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799561|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799562|NCT01399697|O2|Outcome|TCZ + Placebo (Randomized)|TCZ 8 mg/kg (maximum 800 mg) q4w IV up to Week 28 along with MTX orally at stable dose (10, 15, 17.5 or 20 mg per week) up to Week 16 followed by placebo matched to MTX along with TCZ up to Week 28.
799563|NCT01399697|O1|Outcome|TCZ + MTX (Randomized)|TCZ 8 mg/kg (maximum 800 mg) IV q4w along with MTX orally at a stable dose (10, 15, 17.5 or 20 mg/week) up to Week 28.
799564|NCT01399697|E5|Reported Event|TCZ + Placebo (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and matching placebo MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
799565|NCT01399697|E4|Reported Event|TCZ + MTX (Post-randomization)|TCZ 8 mg/kg (maximum 800 mg) q4w via IV infusion up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive 3 additional IV infusions of TCZ 8 mg/kg between Week 16 and Week 24 and MTX capsules, orally, at a stable dose (10, 15, 17.5, or 20 mg per week, but no maximum dose was set), weekly through Week 24. Response was defined as participants having DAS28 score <=3.2.
799566|NCT01399697|E3|Reported Event|TCZ + Placebo (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and matching MTX placebo in the second part of the study. Response was defined as participants having DAS28 score <=3.2.
799567|NCT01399697|E2|Reported Event|TCZ + MTX (Pre-randomization)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w up to Week 16 (total of 4 infusions). Participants also received MTX capsules, orally at a stable dose (10, 15, 17.5, or 20 mg/week but no maximum dose was set) weekly, up to Week 16. Participants with a response were randomized to receive TCZ and MTX in the second part of the study. Response was defined as participants having DAS28 score less than or equal to (<=)3.2.
799568|NCT01399697|E1|Reported Event|TCZ + MTX (Not Randomized)|Participants received TCZ 8 mg/kg (maximum 800 mg) via IV infusion q4w through Week 24 (total of 7 infusions). Participants also received MTX capsules orally, at a stable dose (10, 15, 17.5, or 20 mg, no maximum dose was defined) weekly from Week 1 through 16.
799569|NCT01399619|B3|Baseline|Total|Total of all reporting groups
799570|NCT01399619|B2|Baseline|Faldaprevir 240mg -T|patient to receive Faldaprevir 240 mg once a day for 12 or 24 weeks and PegIFN/RBV for 24 or 48 weeks + patients who received Faldaprevir 240 mg and discontinued prior to week 12.
799571|NCT01399619|B1|Baseline|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799572|NCT01399619|P4|Participant Flow|Faldaprevir 240 mg -NR (Prior to Re-randomization at Week 12)|Patients initially assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at WK 12.
799573|NCT01399619|P3|Participant Flow|Faldaprevir 240mg-24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799574|NCT01399619|P2|Participant Flow|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799575|NCT01399619|P1|Participant Flow|Faldaprevir 120mg -24W|Faldaprevir (BI 201335) 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799576|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799577|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799578|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799579|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799580|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799581|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799582|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799583|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799584|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799585|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799586|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799587|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799588|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799589|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799590|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799591|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799592|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799593|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799594|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799595|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799596|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799597|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799598|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799599|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799600|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799601|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799602|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799603|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799604|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799605|NCT01399619|O1|Outcome|Faldaprevir 120mg -24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799606|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799607|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799608|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799609|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799610|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799611|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799612|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799613|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799614|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799615|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799616|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799617|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799618|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799619|NCT01399619|O2|Outcome|Faldaprevir 240mg -12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799620|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799621|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799622|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799623|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799624|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799625|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799626|NCT01399619|O5|Outcome|Faldaprevir - Total|Total subjects who were treated with Faldaprevir.
799627|NCT01399619|O4|Outcome|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799628|NCT01399619|O3|Outcome|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue BI 201335 to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799629|NCT01399619|O2|Outcome|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799630|NCT01399619|O1|Outcome|Faldaprevir 120mg - 24W|Faldaprevir 120 mg once a day (QD) combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799631|NCT01399619|E4|Reported Event|Faldaprevir 240mg -T|Faldaprevir 240mg-12w + Faldaprevir 240mg-24w + patients initially randomized or assigned to Faldaprevir 240 mg who discontinued prior to re-randomization at Week 12.
799632|NCT01399619|E3|Reported Event|Faldaprevir 240mg - 24W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to continue Faldaprevir to Week 24, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799633|NCT01399619|E2|Reported Event|Faldaprevir 240mg - 12W|Faldaprevir 240 mg QD plus pegIFN/RBV for 12 weeks followed by re-randomisation at Week 12 to stop Faldaprevir and continue pegIFN/RBV alone until Week 24; at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799634|NCT01399619|E1|Reported Event|Faldaprevir 120mg - 24W|Faldaprevir 120 mg QD combined with pegIFN/RBV for 24 weeks, at Week 24, randomisation of patients who achieved early treatment success (ETS) to an additional 24 weeks of pegIFN/RBV or to stop treatment; patients who did not achieve ETS received pegIFN/RBV until Week 48.
799635|NCT01399593|B3|Baseline|Total|Total of all reporting groups
799636|NCT01399593|B2|Baseline|Standard of Care (SOC)|"Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.~Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment plus an additional 60-day washout period. For those patients randomized to the SOC treatment group who were switched to eculizumab for treatment of AMR, from that point forward their data were no longer included in the Prevention Phase."
799637|NCT01399593|B1|Baseline|Eculizumab|"Patients in the eculizumab treatment group were to receive eculizumab for 9 weeks according to the following dosing regimen:~Eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.~Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment plus an additional 60-day washout period."
799638|NCT01399593|P2|Participant Flow|Standard of Care|Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
799639|NCT01399593|P1|Participant Flow|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9).
799640|NCT01399593|O2|Outcome|Standard of Care|Patients in the standard of care (SOC) treatment group received prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg.
799641|NCT01399593|O1|Outcome|Eculizumab|Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.
799642|NCT01399593|E2|Reported Event|Standard of Care|"Patients received standard of care (SOC) prophylactic therapy for acute AMR according to the SOC choice at each participating investigative site, which could have included any combination of plasmapheresis (PP) and intravenous immunoglobulin (IVIg). Patients randomized to SOC who were diagnosed with AMR could have received eculizumab for the treatment of AMR after initially receiving PP and/or IVIg. Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment plus an additional 60-day washout period. For those patients randomized to the SOC treatment group who were switched to eculizumab for treatment of AMR, from that point forward their data were no longer included in the Prevention Phase."
799643|NCT01399593|E1|Reported Event|Eculizumab|"Patients were to receive eculizumab 1200 mg prior to allograft transplantation (Day 0, starting approximately one hour prior to kidney allograft reperfusion), eculizumab 900 mg (Days 1, 7, 14, 21, and 28), and eculizumab 1200 mg (Weeks 5, 7 and 9). All doses of eculizumab were administered intravenously.~Data reported are summarized for the Prevention phase of the study, i.e., 9-week treatment with eculizumab plus an additional 60-day washout period."
799647|NCT01399229|P1|Participant Flow|Pregnant, Preterm, In Labor|Pregnant preterm women independently determined to be in labor.
799648|NCT01399229|O1|Outcome|Pregnant Patents With Uterine Contractions|Patient contractions were monitored with both SureCALL® Labor Monitor® and Tocodynamometer. The times of peak contractions recorded by both devices were compared, and the time differences between contractions were assessed.
799651|NCT01399190|P1|Participant Flow|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
799652|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
799653|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
799654|NCT01399190|O1|Outcome|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
799655|NCT01399190|E1|Reported Event|Bevacizumab|Participants received bevacizumab in combination with capecitabine and oxaliplatin according to prescribing information and normal clinical practice.
799656|NCT01399125|B3|Baseline|Total|Total of all reporting groups
799657|NCT01399125|B2|Baseline|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
799658|NCT01399125|B1|Baseline|Rivastigmine Patch|Once-daily target patch size 10 cm²
799659|NCT01399125|P2|Participant Flow|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
799660|NCT01399125|P1|Participant Flow|Rivastigmine Patch|Once-daily target patch size 10 cm²
799661|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
799662|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
799663|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
799664|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
799665|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
799666|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
799667|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
799668|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
799669|NCT01399125|O2|Outcome|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
799670|NCT01399125|O1|Outcome|Rivastigmine Patch|Once-daily target patch size 10 cm²
799671|NCT01399125|E2|Reported Event|Rivastigmine Capsule|Twice-daily target dose of 6 mg oral capsule
799672|NCT01399125|E1|Reported Event|Rivastigmine Patch|Once-daily target patch size 10 cm²
799673|NCT01399099|B1|Baseline|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
799674|NCT01399099|P1|Participant Flow|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
799675|NCT01399099|O2|Outcome|Control Side|Half of the abdomnioplasty incision was treated according to the Investigator’s standard of care. Participant served as his/her own control.
799676|NCT01399099|O1|Outcome|Treated Side|Half of the abdomnioplasty incision was treated with the embrace device.
799677|NCT01399099|E1|Reported Event|All Study Participants|Half of the abdomnioplasty incision was treated with the embrace device. Half of the abdomnioplasty incision was treated according to the investigator’s standard of care. Participant served as his own control.
799678|NCT01399047|B3|Baseline|Total|Total of all reporting groups
799679|NCT01399047|B2|Baseline|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
799680|NCT01399047|B1|Baseline|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
799681|NCT01399047|P2|Participant Flow|Group B: Placebo to Mycophenolate Crossover|Subjects received one treatment period (8 weeks) of placebo, then, after a 4-week washout, received one treatment period (8 weeks) of mycophenolate, in a blinded manner.
799682|NCT01399047|P1|Participant Flow|Group A: Mycophenolate to Placebo Crossover|Subjects received one treatment period (8 weeks) of mycophenolate, then, after a 4-week washout, received one treatment period (8 weeks) of placebo, in a blinded manner.
799683|NCT01399047|O2|Outcome|Placebo|Includes data from all subjects while on placebo, regardless of treatment order.
799684|NCT01399047|O1|Outcome|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of treatment order.
799685|NCT01399047|E2|Reported Event|Placebo|Includes data from all subjects while on placebo, regardless of order.
799686|NCT01399047|E1|Reported Event|Mycophenolate|Includes data from all subjects while on mycophenolate, regardless of order.
799687|NCT01399008|B4|Baseline|Total|Total of all reporting groups
799688|NCT01399008|B3|Baseline|Placebo|Placebo plus Allopurinol 300 mg
799689|NCT01399008|B2|Baseline|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
799690|NCT01399008|B1|Baseline|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
799691|NCT01399008|P3|Participant Flow|Placebo|Placebo plus Allopurinol 300 mg
799692|NCT01399008|P2|Participant Flow|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
799693|NCT01399008|P1|Participant Flow|Arhalofenate 400 mg|Arhalofenate 400 mg plus allopurinol 300 mg
799694|NCT01399008|O3|Outcome|Placebo|Placebo plus Allopurinol 300 mg
799695|NCT01399008|O2|Outcome|Arhalofenate 600 mg|Arhalofenate 600 mg plus allopurinol 300 mg
799697|NCT01399008|E3|Reported Event|Placebo Plus Allopurinol 300 mg|Placebo plus allopurinol 300 mg (Safety Population)
799698|NCT01399008|E2|Reported Event|Arhalofenate 600 mg Plus Allopurinol 300 mg|Arhalofenate 600 mg plus allopurinol 300 mg (Safety Population)
799699|NCT01399008|E1|Reported Event|Arhalofenate 400 mg Plus Allopurinol 300 mg|Arhalofenate 400 mg plus allopurinol 300 mg (Safety Population)
799700|NCT01398982|B3|Baseline|Total|Total of all reporting groups
799720|NCT01398839|B2|Baseline|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
799701|NCT01398982|B2|Baseline|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799702|NCT01398982|B1|Baseline|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799703|NCT01398982|P2|Participant Flow|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799704|NCT01398982|P1|Participant Flow|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799705|NCT01398982|O2|Outcome|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799706|NCT01398982|O1|Outcome|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799707|NCT01398982|E2|Reported Event|Bupivacaine (Study Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799708|NCT01398982|E1|Reported Event|Isotonic Saline (Control Group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine or Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine or Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
799709|NCT01398956|B1|Baseline|Levetiracetam|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
799710|NCT01398956|P1|Participant Flow|Levetiracetam|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
799711|NCT01398956|O1|Outcome|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
799712|NCT01398956|O1|Outcome|Levetiracetam (FAS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
799713|NCT01398956|O1|Outcome|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
799714|NCT01398956|E1|Reported Event|Levetiracetam (SS)|Levetiracetam dose was be adjusted at the investigator’s discretion in the range from 20mg/kg/day or 1000mg/day to 60mg/kg/day or 3000mg/day during this study
799715|NCT01398852|B1|Baseline|CXL Treatment|All eyes to be treated with riboflavin and UV light
799716|NCT01398852|P1|Participant Flow|CXL Treatment|All eyes to be treated with riboflavin and UV light
799717|NCT01398852|O1|Outcome|CXL Treatment|All eyes to be treated with riboflavin and UV light
799721|NCT01398839|B1|Baseline|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
799722|NCT01398839|P2|Participant Flow|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
799723|NCT01398839|P1|Participant Flow|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
799724|NCT01398839|O2|Outcome|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
799725|NCT01398839|O1|Outcome|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
799726|NCT01398839|E2|Reported Event|Sham Control|Riboflavin : Both treatment and sham groups will receive riboflavin
799727|NCT01398839|E1|Reported Event|CXL Treatment|"VEGA UV-A Illumination System : Only subjects assigned to the treatment group will receive treatment with the UV Light~Riboflavin : Both treatment and sham groups will receive riboflavin"
799728|NCT01398787|B1|Baseline|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
799729|NCT01398787|P1|Participant Flow|AIR OPTIX® COLORS/FRESHLOOK® COLORBLENDS|AIR OPTIX® COLORS and FRESHLOOK® COLORBLENDS, contralateral wear
799730|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
799731|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
799732|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
799733|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
799734|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
799735|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
799736|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
799737|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
799738|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
799739|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
799740|NCT01398787|O2|Outcome|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 1 of 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye for up to 10 minutes
799741|NCT01398787|O1|Outcome|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 1 of 4 colors (gray, blue, green, pure hazel) worn in one eye for up to 10 minutes
799742|NCT01398787|E2|Reported Event|FRESHLOOK® COLORBLENDS|Phemfilcon A hydrogel contact lens in 4 colors (ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel) worn in one eye, up to 10 minutes each
799743|NCT01398787|E1|Reported Event|AIR OPTIX® COLORS|Lotrafilcon B silicone hydrogel contact lens in 4 colors (gray, blue, green, pure hazel) worn in one eye, up to 10 minutes each
799744|NCT01398514|B3|Baseline|Total|Total of all reporting groups
799745|NCT01398514|B2|Baseline|Placebo|Matched pill placebo
799746|NCT01398514|B1|Baseline|Active Medication|Escitalopram 10mg/day
799747|NCT01398514|P2|Participant Flow|Placebo|Matched pill placebo
799748|NCT01398514|P1|Participant Flow|Active Medication|Escitalopram 10mg/day
799749|NCT01398514|O4|Outcome|Placebo CS+|
799750|NCT01398514|O3|Outcome|Placebo CS-|
799751|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
799752|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
799753|NCT01398514|O4|Outcome|Placebo CS+|
799754|NCT01398514|O3|Outcome|Placebo CS-|
799755|NCT01398514|O2|Outcome|Active Medication CS+|Matched pill placebo
799756|NCT01398514|O1|Outcome|Active Medication CS-|Escitalopram 10mg/day
799757|NCT01398514|E2|Reported Event|Placebo|Matched pill placebo
799758|NCT01398514|E1|Reported Event|Active Medication|Escitalopram 10mg/day
799777|NCT01398475|E3|Reported Event|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
799778|NCT01398475|E2|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometer (mcm)] administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
799759|NCT01398475|B1|Baseline|Entire Study Population|"Includes groups randomized to receive any of the following study drugs as the first intervention.~LY3009104 Reference Formulation (RF): 8-milligram (mg) dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~LY3009104 Test Formulation 1 (TF1), 20 micrometers (mcm): 8-mg dose of LY3009104 TF1 [one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 mcm] administered once in a fasted state.~LY3009104 Test Formulation 2 (TF2), 50 mcm, fasted: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~LY3009104 TF2, 50 mcm, fed: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal."
799760|NCT01398475|P4|Participant Flow|LY 50-mcm Fed, LY 50-mcm Fasted, LY RF, LY 20-mcm|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~Second intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~Fourth Intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
799761|NCT01398475|P3|Participant Flow|LY 50-mcm Fasted, LY 20-mcm, LY 50-mcm Fed, LY RF|"First intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~Fourth intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
799762|NCT01398475|P2|Participant Flow|LY 20-mcm, LY RF, LY 50-mcm Fasted, LY 50-mcm Fed|"First intervention: 8-mg dose of LY3009104 TF1 (one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 RF (two 4-mg phosphate salt capsules) administered once in a fasted state.~Third intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal.~There was a washout period of 5 to 7 days between doses of study drug."
799763|NCT01398475|P1|Participant Flow|LY3009104 (LY) RF, LY 50-mcm Fed, LY 20-mcm, LY 50-mcm Fasted|"First intervention: 8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state.~Second intervention: 8-mg dose of LY3009104 test formulation 2 [TF2, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 50 micrometers (mcm)] administered once with a high-fat, high calorie meal.~Third intervention: 8-mg dose of LY3009104 test formulation 1 (TF1, one 8-mg tablet, free base formulation, target API particle size of 20 mcm) administered once in a fasted state.~Fourth intervention: 8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state.~There was a washout period of 5 to 7 days between doses of study drug."
799764|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
799765|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
799766|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
799767|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
799768|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
799769|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
799770|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
799771|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
799772|NCT01398475|O4|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
799773|NCT01398475|O3|Outcome|LY3009104 Test Formulation 2 (50-mcm, Fed)|8-mg dose of LY3009104 test formulation 2 (TF2, one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once with a high-fat, high calorie meal in Period 1, 2, 3, or 4.
799774|NCT01398475|O2|Outcome|LY3009104 Test Formulation 1 (20-mcm)|8-mg dose of LY3009104 test formulation 1 [TF1, one 8-mg tablet, free base formulation, target active pharmaceutical ingredient (API) particle size of 20 micrometers (mcm)] administered once in a fasted state in Period 1, 2, 3, or 4.
799775|NCT01398475|O1|Outcome|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
799776|NCT01398475|E4|Reported Event|LY3009104 Test Formulation 2 (50-mcm, Fasted)|8-mg dose of LY3009104 TF2 (one 8-mg tablet, free base formulation, target API particle size of 50 mcm) administered once in a fasted state in Period 1, 2, 3, or 4.
799779|NCT01398475|E1|Reported Event|LY3009104 Reference Formulation|8-milligram (mg) dose of LY3009104 reference formulation (RF, two 4-mg phosphate salt capsules) administered once in a fasted state in Period 1, 2, 3, or 4.
799780|NCT01398410|B3|Baseline|Total|Total of all reporting groups
799781|NCT01398410|B2|Baseline|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
799782|NCT01398410|B1|Baseline|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
799783|NCT01398410|P2|Participant Flow|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
799784|NCT01398410|P1|Participant Flow|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
799785|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
799786|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
799787|NCT01398410|O2|Outcome|Rabeprazole 10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
799788|NCT01398410|O1|Outcome|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
799789|NCT01398410|E2|Reported Event|Rabeprazole10 mg|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
799790|NCT01398410|E1|Reported Event|Rabeprazole 5 mg|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
799791|NCT01398176|B3|Baseline|Total|Total of all reporting groups
799792|NCT01398176|B2|Baseline|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
799793|NCT01398176|B1|Baseline|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
799794|NCT01398176|P2|Participant Flow|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
799795|NCT01398176|P1|Participant Flow|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
799796|NCT01398176|O2|Outcome|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
799797|NCT01398176|O1|Outcome|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
799798|NCT01398176|E2|Reported Event|6 Ounces of Mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
799799|NCT01398176|E1|Reported Event|3 Ounces of Mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
799800|NCT01397890|B3|Baseline|Total|Total of all reporting groups
799801|NCT01397890|B2|Baseline|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799802|NCT01397890|B1|Baseline|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799803|NCT01397890|P2|Participant Flow|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799804|NCT01397890|P1|Participant Flow|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799805|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799806|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799807|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799808|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799809|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799810|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799811|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799812|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799813|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799814|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799815|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799816|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799817|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799818|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799819|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799820|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799821|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799822|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799823|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799824|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799825|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799826|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799827|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799828|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799829|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799830|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799832|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799833|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799834|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799835|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799836|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799837|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799838|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799839|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799840|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799841|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799842|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799843|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799844|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799845|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799846|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799847|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799848|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799849|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799850|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799851|NCT01397890|O2|Outcome|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799852|NCT01397890|O1|Outcome|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799853|NCT01397890|E2|Reported Event|Spiriva|Spiriva 18 μg/inhalation, 1 inhalation once daily
799854|NCT01397890|E1|Reported Event|Symbicort+Spiriva|Budesonide/formoterol (Symbicort Turbuhaler 160/4.5μg/inhalation, 2 inhalations twice daily) added to tiotropium (Spiriva 18 μg/inhalation, 1 inhalation once daily)
799855|NCT01397851|B3|Baseline|Total|Total of all reporting groups
799856|NCT01397851|B2|Baseline|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
799857|NCT01397851|B1|Baseline|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
799858|NCT01397851|P2|Participant Flow|Treatment|
799859|NCT01397851|P1|Participant Flow|Control|
799860|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
799861|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
799862|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
799863|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
799864|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
799865|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
799866|NCT01397851|O2|Outcome|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
799867|NCT01397851|O1|Outcome|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
799868|NCT01397851|E2|Reported Event|Control|Smallholder farmers in the control group are informed that they had a chance to win an insecticide-treated mosquito net in a raffle, but did not end up winning
799869|NCT01397851|E1|Reported Event|Treatment: Insecticide-treated Net|"Smallholder farmers in the treatment group are informed that they won a raffle, and receive a free insecticide-treated net~Insecticide-treated net (BASF Incerceptor): One per farmer, once during the 2010-2011 season"
799870|NCT01397786|B4|Baseline|Total|Total of all reporting groups
800208|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
799871|NCT01397786|B3|Baseline|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799872|NCT01397786|B2|Baseline|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799873|NCT01397786|B1|Baseline|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799874|NCT01397786|P3|Participant Flow|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799875|NCT01397786|P2|Participant Flow|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799876|NCT01397786|P1|Participant Flow|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786 .
799877|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799878|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799879|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799880|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799881|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799882|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799883|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799884|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799885|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799886|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799887|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799888|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799889|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799890|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799891|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799892|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
800243|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800244|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
799893|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799894|NCT01397786|O3|Outcome|De Novo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799895|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799896|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799897|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799898|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799899|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799900|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799901|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799902|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799903|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799904|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799905|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799906|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799907|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799908|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799909|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799910|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799911|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799912|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799913|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799914|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799915|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799916|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799917|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799918|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799919|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799920|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799921|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799922|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799923|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799924|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799925|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799926|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799927|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799928|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799929|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799930|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799931|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799932|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799933|NCT01397786|O4|Outcome|Total|Participants who rolled over from, and received blinded brexpiprazole/placebo in, one of the randomized, double blind, placebo controlled Phase 3 efficacy studies (Vector, NCT01396421;Beacon, NCT01393613; and Equator, NCT01668797); or de novo patients, All received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799934|NCT01397786|O3|Outcome|De Novo|Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
800025|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
799935|NCT01397786|O2|Outcome|Prior Placebo|Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799989|NCT01397448|P1|Participant Flow|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799936|NCT01397786|O1|Outcome|Prior Brexpiprazole|Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.
799937|NCT01397786|E4|Reported Event|De Novo (Phase B)|"Participants who had not previously participated in a brexpiprazole clinical study and who received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.~NOTE: Five participants from Phase B - Denovo were excluded in this analysis."
799938|NCT01397786|E3|Reported Event|Prior Placebo (Phase B)|"Participants who rolled over from, and received blinded placebo in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786.~Participants who received at least 1 dose of study drug were included in this phase.~NOTE: One participant each from the trials P33110230 and P33110231 were excluded in this analysis."
799939|NCT01397786|E2|Reported Event|Prior Brexpiprazole (Phase B)|"Participants who rolled over from, and received blinded brexpiprazole in, one of the randomized, double-blind, placebo-controlled Phase 3 efficacy studies (Vector, NCT01396421; Beacon, NCT01393613; and Equator, NCT01668797); all received 1-4 mg of daily treatment with open label brexpiprazole in trial NCT01397786. Participants who received at least 1 dose of study drug were included in this phase.~NOTE: Six participants from the trial P33110231 were excluded in this analysis."
799940|NCT01397786|E1|Reported Event|De Novo (Phase A)|"Participants underwent cross-titration to oral brexpiprazole for 4 weeks in Phase A. DeNovo participants in Phase A received brexpiprazole monotherapy starting dose of 2 mg daily at the conversion Week 4 visit (baseline visit of Phase B). Participants who received at least 1 dose of study drug were included in this phase.~NOTE: 12 participants from the trial P33110232 were excluded in this analysis."
799941|NCT01397747|B1|Baseline|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
799942|NCT01397747|P1|Participant Flow|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
799943|NCT01397747|O2|Outcome|FIT Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
799944|NCT01397747|O1|Outcome|Multitarget DNA Test Results|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
799945|NCT01397747|E1|Reported Event|Average Risk Patients|Subjects will be men and women, 50-84 years of age, inclusive, who are at average risk of developing colorectal cancer. We compared a noninvasive, multitarget stool DNA test with fecal immunochemical test (FIT) in persons at average risk for colorectal cancer. Results were compared to colonoscopy and histopathology was performed on any biopsy or excised lesions.
799946|NCT01397617|B4|Baseline|Total|Total of all reporting groups
799947|NCT01397617|B3|Baseline|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
799948|NCT01397617|B2|Baseline|NobelActive External|"NobelActive External implant~NobelActive External implant"
799949|NCT01397617|B1|Baseline|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
799950|NCT01397617|P3|Participant Flow|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
799951|NCT01397617|P2|Participant Flow|NobelActive External|"NobelActive External implant~NobelActive External implant"
799952|NCT01397617|P1|Participant Flow|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
799953|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant: Dental implant"
799954|NCT01397617|O2|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant: Dental implant"
799955|NCT01397617|O1|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant: Dental implant"
799956|NCT01397617|O3|Outcome|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
799957|NCT01397617|O2|Outcome|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
799958|NCT01397617|O1|Outcome|NobelActive External|"NobelActive External implant~NobelActive External implant"
799959|NCT01397617|E3|Reported Event|NobelReplace Tapered Groovy|"NobelReplace Tapered Groovy implant~NobelReplace Tapered Groovy implant"
799960|NCT01397617|E2|Reported Event|NobelActive Internal|"NobelActive Internal implant~NobelActive Internal implant"
799961|NCT01397617|E1|Reported Event|NobelActive External|"NobelActive External implant~NobelActive External implant"
799962|NCT01397591|B1|Baseline|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
800240|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
799990|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
800383|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
799963|NCT01397591|P1|Participant Flow|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
799964|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
799965|NCT01397591|O1|Outcome|Ofatumumab in Combination With Bortezomib|"All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
799966|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
799967|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
799968|NCT01397591|O1|Outcome|Treatment (Monoclonal Antibody and Enzyme Inhibitor Therapy)|"Patients receive ofatumumab IV over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ofatumumab: Given IV~bortezomib: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~biopsy: Optional correlative studies~quality-of-life assessment: Ancillary studies~polymorphism analysis: Correlative studies~flow cytometry: Correlative studies"
799969|NCT01397591|E1|Reported Event|Ofatumumab in Combination With Bortezomib|All patients were given Ofatumumab in combination with Bortezomib in treatment cycles lasting 28 days. Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
799970|NCT01397461|B4|Baseline|Total|Total of all reporting groups
799971|NCT01397461|B3|Baseline|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
799972|NCT01397461|B2|Baseline|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
799973|NCT01397461|B1|Baseline|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
799974|NCT01397461|P3|Participant Flow|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
799975|NCT01397461|P2|Participant Flow|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
799976|NCT01397461|P1|Participant Flow|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
799977|NCT01397461|O3|Outcome|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
799978|NCT01397461|O2|Outcome|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
799979|NCT01397461|O1|Outcome|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
799980|NCT01397461|E3|Reported Event|Retapamulin 1% Ointment|"1% ointment~retapamulin 1% ointment: ointment"
799981|NCT01397461|E2|Reported Event|Ozenoxacin Placebo|"cream~ozenoxacin placebo: cream"
799982|NCT01397461|E1|Reported Event|Ozenoxacin 1% Cream|"1% cream~ozenoxacin 1% cream: 1% cream"
799983|NCT01397448|B4|Baseline|Total|Total of all reporting groups
799984|NCT01397448|B3|Baseline|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
799985|NCT01397448|B2|Baseline|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799986|NCT01397448|B1|Baseline|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799987|NCT01397448|P3|Participant Flow|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
799988|NCT01397448|P2|Participant Flow|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799991|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799992|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799993|NCT01397448|O3|Outcome|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
799994|NCT01397448|O2|Outcome|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799995|NCT01397448|O1|Outcome|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799996|NCT01397448|E3|Reported Event|Teprenone 150 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg capsule three times daily after each meal.
799997|NCT01397448|E2|Reported Event|Rabeprazole 10 mg|Orally administered E3810 (Rabeprazole) 5mg placebo tablet and 10mg tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799998|NCT01397448|E1|Reported Event|Rabeprazole 5 mg|Orally administered E3810 (Rabeprazole) 5mg tablet and E3810 10mg placebo tablet once daily after breakfast; and orally administered Teprenone 50mg placebo capsule three times daily after each meal.
799999|NCT01397409|B11|Baseline|Total|Total of all reporting groups
800000|NCT01397409|B10|Baseline|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
800001|NCT01397409|B9|Baseline|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800002|NCT01397409|B8|Baseline|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800003|NCT01397409|B7|Baseline|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800004|NCT01397409|B6|Baseline|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800005|NCT01397409|B5|Baseline|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800006|NCT01397409|B4|Baseline|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
800007|NCT01397409|B3|Baseline|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
800008|NCT01397409|B2|Baseline|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
800009|NCT01397409|B1|Baseline|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
800010|NCT01397409|P10|Participant Flow|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
800011|NCT01397409|P9|Participant Flow|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800012|NCT01397409|P8|Participant Flow|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800013|NCT01397409|P7|Participant Flow|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800014|NCT01397409|P6|Participant Flow|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800015|NCT01397409|P5|Participant Flow|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800016|NCT01397409|P4|Participant Flow|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
800017|NCT01397409|P3|Participant Flow|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
800018|NCT01397409|P2|Participant Flow|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
800019|NCT01397409|P1|Participant Flow|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
800020|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
800021|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
800022|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800023|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
800024|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
800026|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800027|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800384|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800028|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800029|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800030|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800031|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800032|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800033|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800034|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800035|NCT01397409|O3|Outcome|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks.
800036|NCT01397409|O2|Outcome|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16
800037|NCT01397409|O1|Outcome|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800038|NCT01397409|O3|Outcome|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800039|NCT01397409|O2|Outcome|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800040|NCT01397409|O1|Outcome|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800041|NCT01397409|O4|Outcome|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection
800042|NCT01397409|O3|Outcome|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection.
800043|NCT01397409|O2|Outcome|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection
800044|NCT01397409|O1|Outcome|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
800045|NCT01397409|O1|Outcome|Stage 1 All Participants|Participants in Stage 1 received an intravitreal injection of AGN-150998 with doses ranging from 1.0 to 4.2 mg.
800046|NCT01397409|E10|Reported Event|Stage 3: Ranibizumab 0.5 mg|Stage 3: ranibizumab 0.5 mg given as intravitreal injections every 4 weeks for 16 weeks
800047|NCT01397409|E9|Reported Event|Stage 3: AGN-150998 1.0 mg|Stage 3: AGN-150998 1.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800048|NCT01397409|E8|Reported Event|Stage 3: AGN-150998 2.0 mg|Stage 3: AGN-150998 2.0 mg given as intravitreal injections at Baseline, Weeks 4 and 8, followed by sham injections at Weeks 12 and 16.
800049|NCT01397409|E7|Reported Event|Stage 2: Ranibizumab 0.5 mg|Stage 2: ranibizumab 0.5 mg given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800050|NCT01397409|E6|Reported Event|Stage 2: AGN-150998 3.0 mg|Stage 2: AGN-150998 3.0 mg (one dose below highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800051|NCT01397409|E5|Reported Event|Stage 2: AGN-150998 4.2 mg|Stage 2: AGN-150998 4.2 mg (highest tolerated dose from Stage 1) given as a single intravitreal injection at baseline. A second intravitreal injection will be given by week 16.
800052|NCT01397409|E4|Reported Event|Stage 1: AGN-150998 1.0 mg|Stage 1: AGN-150998 1.0 mg given as a single intravitreal injection.
800053|NCT01397409|E3|Reported Event|Stage 1: AGN-150998 2.0 mg|Stage 1: AGN-150998 2.0 mg given as a single intravitreal injection
800054|NCT01397409|E2|Reported Event|Stage 1: AGN-150998 3.0 mg|Stage 1: AGN-150998 3.0 mg given as a single intravitreal injection.
800055|NCT01397409|E1|Reported Event|Stage 1: AGN-150998 4.2 mg|Stage 1: AGN-150998 4.2 mg given as a single intravitreal injection.
800056|NCT01397253|B3|Baseline|Total|Total of all reporting groups
800057|NCT01397253|B2|Baseline|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
800058|NCT01397253|B1|Baseline|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
800314|NCT01396382|P1|Participant Flow|68Ga-DOTATATE PET Scan|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
800082|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800385|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800059|NCT01397253|P2|Participant Flow|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
800060|NCT01397253|P1|Participant Flow|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
800061|NCT01397253|O2|Outcome|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
800062|NCT01397253|O1|Outcome|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
800063|NCT01397253|E2|Reported Event|Automated Communication Tools|"An enhanced version of MedTrak (the present system of PCP notification). Electronic medical record links will be developed and used to allow automated communication with the PCP.~Automated communication tools will include:~PCP notification of patient admission and location~Data on medications begun on admission~Automated alerts on changes in patient status and location while the patient is hospitalized~Links to the EMR and to hospital physician contact information on all email alerts~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP~Automatic reporting to PCPs of test results pending at discharge~Electronic delivery of final discharge summaries"
800064|NCT01397253|E1|Reported Event|(Usual) MedTrak System of PCP Notification|MedTrak, the information system used by the University of Pittsburgh Medical Center (UPMC), currently notifies PCPs when patients are admitted and discharged from the hospital.
800065|NCT01397084|B1|Baseline|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
800066|NCT01397084|P1|Participant Flow|Esomeprazole 20 mg|esomeprazole 20 mg : esomeprazole 20 mg once daily for 8 weeks
800067|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
800068|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
800069|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
800070|NCT01397084|O1|Outcome|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
800071|NCT01397084|E1|Reported Event|Esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
800072|NCT01396525|B1|Baseline|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800073|NCT01396525|P1|Participant Flow|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800074|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800075|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800076|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800077|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800078|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800079|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800080|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800081|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800373|NCT01396226|P1|Participant Flow|AZD2927|AZD2927 solution for infusion
800083|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800084|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800085|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800086|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800087|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800088|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800089|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800090|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800091|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800092|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800093|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800094|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800095|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800096|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800097|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800098|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800099|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800100|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800101|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800102|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800374|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800103|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800104|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800105|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800106|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800107|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800108|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800109|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800110|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800111|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800112|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800113|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800114|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800115|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800116|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800117|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800118|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800119|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800120|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800121|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800122|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800123|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800375|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800124|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800125|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800126|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800127|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800128|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800129|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800130|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800131|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800132|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800133|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800134|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800135|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800136|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800137|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800138|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800139|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800140|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800141|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800142|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800143|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800144|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800145|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800146|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800147|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800148|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800149|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800150|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800151|NCT01396525|O3|Outcome|Stair Climbing Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800152|NCT01396525|O2|Outcome|Walking Speed Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800153|NCT01396525|O1|Outcome|Walking Distance Score|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800154|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800155|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800156|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800157|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800158|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800159|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800160|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800161|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800162|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800163|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800164|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800165|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800166|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800167|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800168|NCT01396525|O1|Outcome|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System: Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800169|NCT01396525|E1|Reported Event|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Omnilink Elite™ Peripheral Balloon-Expandable Stent System : Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
800170|NCT01396512|B3|Baseline|Total|Total of all reporting groups
800171|NCT01396512|B2|Baseline|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
800172|NCT01396512|B1|Baseline|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
800173|NCT01396512|P2|Participant Flow|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
800174|NCT01396512|P1|Participant Flow|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
800175|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
800176|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
800177|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
800178|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
800179|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
800180|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
800181|NCT01396512|O2|Outcome|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
800182|NCT01396512|O1|Outcome|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
800183|NCT01396512|E2|Reported Event|CD.JEVAX™ Vaccine Group|Participants age 12 to 24 months received one dose of CD.JEVAX™
800184|NCT01396512|E1|Reported Event|IMOJEV™ Vaccine Group|Participants age 12 to 24 months received one dose of IMOJEV™
800185|NCT01396434|B4|Baseline|Total|Total of all reporting groups
800186|NCT01396434|B3|Baseline|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
800187|NCT01396434|B2|Baseline|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
800188|NCT01396434|B1|Baseline|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
800189|NCT01396434|P3|Participant Flow|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
800190|NCT01396434|P2|Participant Flow|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
800191|NCT01396434|P1|Participant Flow|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
800192|NCT01396434|O3|Outcome|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
800193|NCT01396434|O2|Outcome|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
800194|NCT01396434|O1|Outcome|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
800195|NCT01396434|E3|Reported Event|13vPnC (Prevenar 13), Cohort 3|13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
800196|NCT01396434|E2|Reported Event|13vPnC (Prevenar 13), Cohort 2|13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.
800197|NCT01396434|E1|Reported Event|13vPnC (Prevenar 13), Cohort 1|Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.
800198|NCT01396421|B5|Baseline|Total|Total of all reporting groups
800199|NCT01396421|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
800200|NCT01396421|B3|Baseline|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800201|NCT01396421|B2|Baseline|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800202|NCT01396421|B1|Baseline|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800203|NCT01396421|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
800204|NCT01396421|P3|Participant Flow|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800205|NCT01396421|P2|Participant Flow|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800206|NCT01396421|P1|Participant Flow|Brexpiprazole 4 mg|"Brexpiprazole 4 milligram (mg) tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800207|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800209|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800210|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800211|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks
800212|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800213|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800214|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800215|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800216|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800217|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800218|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800219|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800220|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800221|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800222|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800223|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800224|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800225|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800226|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800227|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800228|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800229|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800230|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800231|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800232|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800233|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day by Day 5."
800234|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800235|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800236|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800237|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800238|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800239|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800241|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800242|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2"
800245|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800246|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800247|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800248|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800249|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800250|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800251|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800252|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800253|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a r5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800254|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800255|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800256|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800257|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800258|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800259|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800260|NCT01396421|O3|Outcome|Brexpiprazole 0.25mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800261|NCT01396421|O2|Outcome|Brexpiprazole 2mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5)."
800262|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800263|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800264|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800265|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800266|NCT01396421|O1|Outcome|Brexpiprazole 4 mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800267|NCT01396421|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800268|NCT01396421|O3|Outcome|Brexpiprazole 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks
800269|NCT01396421|O2|Outcome|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5 day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800270|NCT01396421|O1|Outcome|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1),and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800271|NCT01396421|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
800272|NCT01396421|E3|Reported Event|Brexpiprazile 0.25 mg|Brexpiprazole 0.25mg tablet once daily for 6 weeks.
800273|NCT01396421|E2|Reported Event|Brexpiprazole 2 mg|"Brexpiprazole 2mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 5-day period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose by Day 5."
800376|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800274|NCT01396421|E1|Reported Event|Brexpiprazole 4mg|"Brexpiprazole 4mg tablet once daily for 6 weeks.~Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2)."
800275|NCT01396395|B3|Baseline|Total|Total of all reporting groups
800276|NCT01396395|B2|Baseline|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800386|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800277|NCT01396395|B1|Baseline|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800278|NCT01396395|P2|Participant Flow|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800279|NCT01396395|P1|Participant Flow|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 milligram (mg) tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors (ACEIs) as permitted by disease condition or as per standard local practices or prescribed per discretion of the investigators.
800280|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800281|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800282|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800283|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800284|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800285|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800286|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800287|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800288|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800289|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800290|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800291|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800292|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800293|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800315|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE will be administered to patient in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
800294|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800295|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800296|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800297|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800298|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800299|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800300|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800301|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800302|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800303|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800304|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800305|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800306|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies ( aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800307|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800308|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800309|NCT01396395|O2|Outcome|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800310|NCT01396395|O1|Outcome|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800311|NCT01396395|E2|Reported Event|Standard Treatment|The subjects received one of the standard antianginal therapies which included but not limited to aspirin, beta blockers, lipid lowering statins and ACEIs as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators.
800312|NCT01396395|E1|Reported Event|Standard Treatment Plus Nicorandil|The subjects received nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with one of the standard antianginal therapies (aspirin, beta-blockers, lipid lowering statins and angiotensin-converting enzyme inhibitors [ACEIs] as permitted by disease condition or as per standard local practices or prescribed per discretion of investigators).
800313|NCT01396382|B1|Baseline|Imaging/Scans|68Ga-DOTATATE PET scans performed on subjects. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
800316|NCT01396382|O1|Outcome|68Ga-DOTATATE PET|68Ga-DOTATATE PET scan will be administered to patients in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
800317|NCT01396382|E1|Reported Event|68Ga-DOTATATE PET Scan|Patients will receive 68Ga-DOTATATE PET scans. 68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.
800318|NCT01396265|B1|Baseline|Overall Study|This was a open-label, two period, fixed sequence trial clinical phase I trial in healthy male volunteers.
800319|NCT01396265|P1|Participant Flow|Overall Group|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800320|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800321|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800322|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800323|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800324|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800325|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800326|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800327|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800328|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800329|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800330|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800331|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800332|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800333|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800334|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800335|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800336|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800337|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800338|NCT01396265|O2|Outcome|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800339|NCT01396265|O1|Outcome|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800340|NCT01396265|E2|Reported Event|Afatinib + Rifa|Subjects were treated with Rifa 600mg once daily (evening) from Day -7 to -1 and with a single morning dose of Afatinib 40mg on Day 1.
800341|NCT01396265|E1|Reported Event|Afatinib|Subjects were treated with a single morning dose of Afatinib 40mg on Day 1.
800342|NCT01396239|B4|Baseline|Total|Total of all reporting groups
800343|NCT01396239|B3|Baseline|Placebo|Placebo: phosphate buffered saline solution identical in appearance to eteplirsen for 24 weeks
800344|NCT01396239|B2|Baseline|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
800345|NCT01396239|B1|Baseline|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
800346|NCT01396239|P4|Participant Flow|Placebo - Week 24 Biopsy|Placebo for 24 weeks with muscle biopsy at Week 24
800347|NCT01396239|P3|Participant Flow|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen for 24 weeks
800348|NCT01396239|P2|Participant Flow|Placebo - Week 12 Biopsy|Placebo for 24 Weeks with muscle Biopsy at Week 12
800349|NCT01396239|P1|Participant Flow|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen for 24 weeks
800350|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
800351|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
800352|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
800353|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
800354|NCT01396239|O2|Outcome|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
800355|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
800356|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
800357|NCT01396239|O2|Outcome|50mg/kg Eteplirsen|50mg/kg eteplirsen for 24 weeks
800358|NCT01396239|O1|Outcome|30mg/kg Eteplirsen|30mg/kg eteplirsen for 24 weeks
800359|NCT01396239|O3|Outcome|Placebo|Placebo for 24 weeks
800360|NCT01396239|O2|Outcome|50 mg/kg Eteplirsen|50 mg/kg eteplirsen for 24 weeks
800361|NCT01396239|O1|Outcome|30 mg/kg Eteplirsen|30 mg/kg eteplirsen for 24 weeks
800362|NCT01396239|O4|Outcome|Placebo - Week 12 Biopsy|Placebo - Biopsied after 12 weeks of dosing
800363|NCT01396239|O3|Outcome|AVI-4658 (Eteplirsen) 50 mg/kg|50 mg/kg eteplirsen - Biopsied after 12 weeks of dosing
800364|NCT01396239|O2|Outcome|Placebo - Week 24 Biopsy|Placebo: Biopsied after 24 weeks of dosing
800365|NCT01396239|O1|Outcome|AVI-4658 (Eteplirsen) 30 mg/kg|30 mg/kg eteplirsen - Biopsied after 24 weeks of dosing
800366|NCT01396239|E3|Reported Event|Placebo|Placebo for 24 weeks - Phosphate buffered saline solution identical in appearance to eteplirsen
800367|NCT01396239|E2|Reported Event|AVI-4658 (Eteplirsen) - 50mg/kg|50 mg/kg eteplirsen for 24 weeks
800368|NCT01396239|E1|Reported Event|AVI-4658 (Eteplirsen) - 30mg/kg|30 mg/kg eteplirsen for 24 weeks
800377|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800378|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800379|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800380|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800381|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800382|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800387|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800388|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800389|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800390|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800391|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800392|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800393|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800394|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800395|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800396|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800397|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800398|NCT01396226|O2|Outcome|Arm 2 - PLACEBO|Placebo solution for intravenous (i.v.) infusion
800399|NCT01396226|O1|Outcome|Arm 1 - AZD2927|AZD2927 solution for intravenous (i.v.) infusion
800400|NCT01396226|E2|Reported Event|PLACEBO|Placebo solution for infusion
800401|NCT01396226|E1|Reported Event|AZD2927|AZD2927 solution for infusion
800402|NCT01396187|B6|Baseline|Total|Total of all reporting groups
800403|NCT01396187|B5|Baseline|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800404|NCT01396187|B4|Baseline|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800405|NCT01396187|B3|Baseline|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800406|NCT01396187|B2|Baseline|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800407|NCT01396187|B1|Baseline|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800408|NCT01396187|P5|Participant Flow|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800409|NCT01396187|P4|Participant Flow|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800410|NCT01396187|P3|Participant Flow|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800411|NCT01396187|P2|Participant Flow|PF-05231023 5 mg|PF-05231023 5 mg (milligram) intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800412|NCT01396187|P1|Participant Flow|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800413|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800414|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800415|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800416|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800417|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800418|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800419|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800420|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800421|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800422|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800423|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800424|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800425|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800426|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800427|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800428|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800429|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800430|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800431|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800432|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800433|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800434|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800435|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800436|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800437|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800438|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800439|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800440|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800441|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800442|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800443|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800444|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800445|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800446|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800447|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800448|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800449|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800450|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800451|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800452|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800453|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800454|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800455|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800456|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800457|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800458|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800459|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800460|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800461|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800462|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800463|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800464|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800465|NCT01396187|O4|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800466|NCT01396187|O3|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800467|NCT01396187|O2|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800468|NCT01396187|O1|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800469|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800470|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800471|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800472|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800473|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800474|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800475|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800476|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800477|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800478|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800479|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800480|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800481|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800482|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800483|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800484|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800485|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800486|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800487|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800488|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800489|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800490|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800491|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800492|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800493|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800494|NCT01396187|O5|Outcome|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800495|NCT01396187|O4|Outcome|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800496|NCT01396187|O3|Outcome|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800497|NCT01396187|O2|Outcome|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800498|NCT01396187|O1|Outcome|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800499|NCT01396187|E5|Reported Event|PF-05231023 140 mg|PF-05231023 140 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800500|NCT01396187|E4|Reported Event|PF-05231023 100 mg|PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800501|NCT01396187|E3|Reported Event|PF-05231023 25 mg|PF-05231023 25 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8 11, 15, 18, 22 and 25.
800502|NCT01396187|E2|Reported Event|PF-05231023 5 mg|PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800503|NCT01396187|E1|Reported Event|Placebo|Placebo matched to PF-05231023 intravenous infusion over approximately 1 hour on Day 1, 4, 8, 11, 15, 18, 22 and 25.
800504|NCT01396161|B8|Baseline|Total|Total of all reporting groups
800505|NCT01396161|B7|Baseline|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800506|NCT01396161|B6|Baseline|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800507|NCT01396161|B5|Baseline|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules PF-05175157 QD for 14 days
800508|NCT01396161|B4|Baseline|PF-05175157 100 mg QD -HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800509|NCT01396161|B3|Baseline|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800510|NCT01396161|B2|Baseline|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
800511|NCT01396161|B1|Baseline|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
800512|NCT01396161|P7|Participant Flow|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800513|NCT01396161|P6|Participant Flow|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 twice daily (BID) for 14 days
800514|NCT01396161|P5|Participant Flow|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800515|NCT01396161|P4|Participant Flow|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800516|NCT01396161|P3|Participant Flow|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 milligram (mg) capsules of PF-05175157 QD for 14 days
800517|NCT01396161|P2|Participant Flow|Placebo - Type 2 Diabetes Mellitus Participants (T2DM)|T2DM participants administered orally matched placebo capsules QD for 14 days
800518|NCT01396161|P1|Participant Flow|Placebo - Healthy and Overweight Participants (HOV)|HOV participants administered orally matched placebo capsules once daily (QD) for 14 days
800519|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
801166|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
800520|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800521|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800522|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800523|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800524|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800525|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800526|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800527|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800528|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800529|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
800530|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
800531|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800532|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800533|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800534|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800535|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800536|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800537|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800538|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800539|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800540|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800541|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800542|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800543|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800544|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800545|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800546|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800547|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800548|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800549|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800550|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800551|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800552|NCT01396161|O4|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800553|NCT01396161|O3|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800554|NCT01396161|O2|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800555|NCT01396161|O1|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800556|NCT01396161|O7|Outcome|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800557|NCT01396161|O6|Outcome|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800558|NCT01396161|O5|Outcome|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800559|NCT01396161|O4|Outcome|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800560|NCT01396161|O3|Outcome|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800561|NCT01396161|O2|Outcome|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
800562|NCT01396161|O1|Outcome|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
800563|NCT01396161|E7|Reported Event|PF-05175157 200 mg QD - T2DM|T2DM participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800564|NCT01396161|E6|Reported Event|PF-05175157 100 mg BID - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 BID for 14 days
800565|NCT01396161|E5|Reported Event|PF-05175157 200 mg QD - HOV|HOV participants administered orally 200 mg capsules of PF-05175157 QD for 14 days
800566|NCT01396161|E4|Reported Event|PF-05175157 100 mg QD - HOV|HOV participants administered orally 100 mg capsules of PF-05175157 QD for 14 days
800567|NCT01396161|E3|Reported Event|PF-05175157 30 mg QD - HOV|HOV participants administered orally 30 mg capsules of PF-05175157 QD for 14 days
800568|NCT01396161|E2|Reported Event|Placebo - T2DM|T2DM participants administered orally matched placebo capsules QD for 14 days
800569|NCT01396161|E1|Reported Event|Placebo - HOV|HOV participants administered orally matched placebo capsules QD for 14 days
800570|NCT01396083|B3|Baseline|Total|Total of all reporting groups
800571|NCT01396083|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800572|NCT01396083|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800573|NCT01396083|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800574|NCT01396083|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
801175|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
800575|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800576|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800577|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800578|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800579|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800580|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800581|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800582|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800583|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800584|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800585|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800586|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800587|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800588|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800589|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800590|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800591|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800592|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800593|NCT01396083|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800594|NCT01396083|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800595|NCT01396083|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800596|NCT01396083|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800597|NCT01396070|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
800598|NCT01396070|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
800599|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
800600|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
800601|NCT01396070|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks (1 cycle)
800602|NCT01396070|O1|Outcome|Overall Response Rate (%)|Overall Response Rate of all patients
800603|NCT01396070|E1|Reported Event|All Participants|All reported AE's on trial
800604|NCT01396057|B3|Baseline|Total|Total of all reporting groups
800605|NCT01396057|B2|Baseline|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800606|NCT01396057|B1|Baseline|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800607|NCT01396057|P2|Participant Flow|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800608|NCT01396057|P1|Participant Flow|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800609|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800610|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800611|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800612|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800613|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800614|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800615|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800616|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800617|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800618|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800619|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800620|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800621|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800622|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800623|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800624|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
801176|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
800625|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800626|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800627|NCT01396057|O2|Outcome|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800628|NCT01396057|O1|Outcome|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800629|NCT01396057|E2|Reported Event|Dexamethasone|Intravitreal implant as per commercial label (700 μg Dexamethasone; long acting release (LAR) over 6 months
800630|NCT01396057|E1|Reported Event|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally
800631|NCT01396044|B3|Baseline|Total|Total of all reporting groups
800632|NCT01396044|B2|Baseline|Verbal Prompting|Verbal prompting with written checklist
800633|NCT01396044|B1|Baseline|Electronic Checklist|Electronic checklist
800634|NCT01396044|P2|Participant Flow|Verbal Prompting|Verbal prompting with written checklist
800635|NCT01396044|P1|Participant Flow|Electronic Checklist|Electronic checklist
800636|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800637|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800638|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800639|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800640|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800641|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800642|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800643|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800644|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800645|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800646|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800647|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800648|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800649|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800650|NCT01396044|O2|Outcome|Verbal Prompting|Verbal prompting with written checklist
800651|NCT01396044|O1|Outcome|Electronic Checklist|Electronic checklist
800652|NCT01396044|E2|Reported Event|Verbal Prompting|Verbal prompting with written checklist
800653|NCT01396044|E1|Reported Event|Electronic Checklist|Electronic checklist
800654|NCT01396005|B3|Baseline|Total|Total of all reporting groups
800655|NCT01396005|B2|Baseline|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800656|NCT01396005|B1|Baseline|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
800657|NCT01396005|P2|Participant Flow|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800658|NCT01396005|P1|Participant Flow|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
800659|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800660|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800661|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800662|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800663|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800664|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800665|NCT01396005|O2|Outcome|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800666|NCT01396005|O1|Outcome|Buprenorphine/Naloxone Alone|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800667|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
800668|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
800669|NCT01396005|O2|Outcome|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
800670|NCT01396005|O1|Outcome|Methadone Alone|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
800671|NCT01396005|E2|Reported Event|Buprenorphine/Naloxone + Boceprevir|Participants receive standard buprenorphine/naloxone maintenance therapy (8/2-24/6 mg, tablets, sublingual, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7
800672|NCT01396005|E1|Reported Event|Methadone + Boceprevir|Participants receive standard methadone maintenance therapy (20-150 mg tablets, liquid, or disket, orally, once per day) on Days 1 through 8 + boceprevir (800 mg [4 x 200 mg capsules], orally, every 8 hours) on Days 2 through 7)
800673|NCT01395966|B4|Baseline|Total|Total of all reporting groups
800674|NCT01395966|B3|Baseline|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
800675|NCT01395966|B2|Baseline|DF277|"Ear drops~DF277: Ear drops"
800676|NCT01395966|B1|Baseline|DF289|"Ear drops~DF289: Ear drops"
800677|NCT01395966|P3|Participant Flow|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
800678|NCT01395966|P2|Participant Flow|DF277|"Ear drops~DF277: Ear drops"
800679|NCT01395966|P1|Participant Flow|DF289|"Ear drops~DF289: Ear drops"
800680|NCT01395966|O3|Outcome|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
800681|NCT01395966|O2|Outcome|DF277|"Ear drops~DF277: Ear drops"
800682|NCT01395966|O1|Outcome|DF289|"Ear drops~DF289: Ear drops"
800683|NCT01395966|E3|Reported Event|DF289 Plus DF277|"Ear drops~DF289 plus DF277: Ear drops"
800684|NCT01395966|E2|Reported Event|DF277|"Ear drops~DF277: Ear drops"
800685|NCT01395966|E1|Reported Event|DF289|"Ear drops~DF289: Ear drops"
800686|NCT01395901|B3|Baseline|Total|Total of all reporting groups
800687|NCT01395901|B2|Baseline|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
800688|NCT01395901|B1|Baseline|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800689|NCT01395901|P2|Participant Flow|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
800690|NCT01395901|P1|Participant Flow|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800691|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
800692|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800693|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
800694|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800695|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
800696|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800697|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
800698|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800699|NCT01395901|O2|Outcome|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
800700|NCT01395901|O1|Outcome|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800701|NCT01395901|E2|Reported Event|Ondansetron and Placebo to Palonosetron|"Intervention: Drug: Comparator: Ondansetron~Ondansetron: Single dose Ondansetron IV:~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;~13 years to less than 17 years dose: 4 mg~Placebo to Palonosetron"
801167|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
800702|NCT01395901|E1|Reported Event|Palonosetron and Placebo to Ondansetron|"Intervention: Drug: Palonosetron~Palonosetron: Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)~Placebo to Ondansetron"
800703|NCT01395888|B3|Baseline|Total|Total of all reporting groups
800704|NCT01395888|B2|Baseline|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
801177|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
800705|NCT01395888|B1|Baseline|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
800706|NCT01395888|P3|Participant Flow|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
800707|NCT01395888|P2|Participant Flow|FF/VI 100/25 µg|Participants (par.) self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
800708|NCT01395888|P1|Participant Flow|Salb/Alb + IBr|Participants were provided with an inhaled short-acting beta2-receptor agonist, salbutamol/albuterol (Salb/Alb), for use as needed throughout the Run-in Period for relief of chronic obstructive pulmonary disease (COPD) symptoms. Ipratropium bromide (IBr) was permitted during the Run-in Period and for up to 4 hours prior to Randomization (Visit 2) if the participant was on a stable dose prior to Screening (Visit 1). Following randomization, IBr was not permitted during exposure to study treatment.
800709|NCT01395888|O2|Outcome|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
800710|NCT01395888|O1|Outcome|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
800711|NCT01395888|E2|Reported Event|Tiotropium Bromide 18 µg|Participants self-administered one inhalation of placebo via an DPI followed by 2 inhalations from a single capsule containing Tiotropiuum Bromide 18 µg via a HandiHaler. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of COPD symptoms.
800712|NCT01395888|E1|Reported Event|FF/VI 100/25 µg|Participants self-administered one inhalation of Fluticasone Furoate /Vilanterol (FF/VI) 100/25 micrograms (µg) via a dry powder inhaler (DPI) followed by 2 inhalations from a single placebo capsule delivered via a HandiHaler in the morning for 12 weeks. An inhaled short-acting beta2-receptor agonist, salbutamol/albuterol, was provided for participants to use as needed throughout the Treatment Period for relief of Chronic Obstructive Pulmonary Disease (COPD) symptoms.
800713|NCT01395823|B3|Baseline|Total|Total of all reporting groups
800714|NCT01395823|B2|Baseline|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
800715|NCT01395823|B1|Baseline|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
800716|NCT01395823|P2|Participant Flow|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
800717|NCT01395823|P1|Participant Flow|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
800718|NCT01395823|O2|Outcome|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
800719|NCT01395823|O1|Outcome|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
800720|NCT01395823|E2|Reported Event|Placebo|placebo: placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
800721|NCT01395823|E1|Reported Event|Ergocalciferol Supplementation|ergocalciferol supplementation: 50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
800722|NCT01395784|B1|Baseline|Withing-subjects, Placebo-Controlled|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
800723|NCT01395784|P1|Participant Flow|Withing-subjects, Placebo-Controlled|"Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.~pioglitazone: A PPARγ agonist, also marketed as Actos."
800724|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
800725|NCT01395784|O1|Outcome|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
800726|NCT01395784|E1|Reported Event|All Participants|Participants will complete the various outcome measures following maintenance period of: Placebo, Pioglitazone 15 mg, and 45 mg.
800727|NCT01394510|B1|Baseline|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
800728|NCT01394510|P1|Participant Flow|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
800791|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters.
800729|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
800730|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
800731|NCT01394510|O1|Outcome|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
800732|NCT01394510|E1|Reported Event|N-acetylcysteine Dose Study|"Subjects will take N-acetylcysteine (NAC) 600 mg twice daily for 2 weeks, then 1200 mg twice daily for an additional 2 weeks. Study procedures will be performed at baseline, after 2 weeks and after 4 weeks.~N-acetylcysteine: 600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks."
800733|NCT01395524|B4|Baseline|Total|Total of all reporting groups
800734|NCT01395524|B3|Baseline|Placebo|Placebo QD, oral treatment
800735|NCT01395524|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
800736|NCT01395524|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
800737|NCT01395524|P3|Participant Flow|Placebo|Placebo QD, oral treatment
800738|NCT01395524|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
800739|NCT01395524|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
800740|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
800741|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
800742|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
800743|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
800744|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
800745|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
800746|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
800747|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
800748|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
800749|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
800750|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
800751|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
800752|NCT01395524|O3|Outcome|Placebo|Placebo QD, oral treatment
800753|NCT01395524|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
800754|NCT01395524|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg QD, oral treatment
800755|NCT01395524|E3|Reported Event|Placebo|
800756|NCT01395524|E2|Reported Event|NKTR-118 25 mg|
800757|NCT01395524|E1|Reported Event|NKTR-118 12.5 mg|
800758|NCT01395394|B4|Baseline|Total|Total of all reporting groups
800759|NCT01395394|B3|Baseline|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800760|NCT01395394|B2|Baseline|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800761|NCT01395394|B1|Baseline|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800762|NCT01395394|P3|Participant Flow|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800763|NCT01395394|P2|Participant Flow|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800789|NCT01395043|B1|Baseline|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
800790|NCT01395043|P1|Participant Flow|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
801168|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
800792|NCT01395043|O1|Outcome|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2,5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
800864|NCT01394614|P2|Participant Flow|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (not vaccinated or vaccinated after the onset of symptoms)
800764|NCT01395394|P1|Participant Flow|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800765|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800766|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800767|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800768|NCT01395394|O3|Outcome|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800769|NCT01395394|O2|Outcome|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800770|NCT01395394|O1|Outcome|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800771|NCT01395394|E3|Reported Event|BH4 Responders|"Participants in this group will use their already prescribed BH4 with the meal challenge and be assessed at a single study visit. They will take their prescribed BH4 with the meal.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800772|NCT01395394|E2|Reported Event|Healthy Controls|"Participants in this group match an enrolled PKU participant in terms of age, gender, and body mass index class. They will participate in a single study visit and will not be given BH4.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800773|NCT01395394|E1|Reported Event|BH4 Non-Responders|"Participants in this group have PKU and were deemed unresponsive to the drug. They will attend their first study visit, and proceed through the meal challenge without BH4. They will then take BH4 for 2 weeks. The second meal challenge will be performed with the participant's final dose of BH4.~Kuvan: Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.~Meal Challenge: At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction"
800774|NCT01395368|B1|Baseline|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
800775|NCT01395368|P1|Participant Flow|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
800776|NCT01395368|O1|Outcome|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month's duration or longer.
800777|NCT01395368|E1|Reported Event|Tinnitus|Participants must be between the ages of 18 and 80. Participants must have subjective, unilateral or bilateral, non-pulsatile tinnitus of 6 month’s duration or longer.
800778|NCT01395277|B3|Baseline|Total|Total of all reporting groups
800779|NCT01395277|B2|Baseline|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
800859|NCT01394692|E2|Reported Event|Conventional Group|standard microsurgical tumor resection
800780|NCT01395277|B1|Baseline|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content . On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the placebo trial (low flavanol group) will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
800781|NCT01395277|P2|Participant Flow|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with low flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with high flavanol content.~During the first visit the low flavanol measures will be performed before and 2 hours following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
800782|NCT01395277|P1|Participant Flow|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate visits to the laboratory; On the first visit measurements will be made before (baseline) and 2 hrs post consumption of a beverage with high flavanol content. On the second study visit measurements will be made before and 2 hrs following consumption of a beverage with low flavanol content.~During the first visit the high flavanol measures will be performed before and 2 hours following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption. During the second visit the low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. Measurements will be performed 2 hrs after consumption."
800783|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The hihg flavanol measures will be performed following consumption of a beverage containing 1,0500 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
800784|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
800785|NCT01395277|O2|Outcome|Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~Placebo Trial: CocoaVia Dark Chocolate Flavored Drink: The placebo trial (low flavanol content) will be performed following consumption of a beverage containing 75 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
800786|NCT01395277|O1|Outcome|High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content (experimental trial), and 2) before and 2 hours following consumption of a beverage with low flavanol content (placebo trial).~CocoaVia Dark Chocolate Flavored Drink: The experimental trial (high flavanol group) will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols. This cocoa flavanol powder will be purchased from Mars Incorporated (Hackettstown, New Jersey) and will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
800787|NCT01395277|E2|Reported Event|Low Flavanol First Then High Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with low flavanol content, and 2) before and 2 hours following consumption of a beverage with high flavanol content.~The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
800788|NCT01395277|E1|Reported Event|High Flavanol First Then Low Flavanol|"The measurements will be made on all study participants on two separate occasions; 1) before and 2 hours following consumption of a beverage with high flavanol content, and 2) before and 2 hours following consumption of a beverage with low flavanol content.~The high flavanol measures will be performed following consumption of a beverage containing 1,050 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol measures will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption."
800860|NCT01394692|E1|Reported Event|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
800793|NCT01395043|E1|Reported Event|Bilateral Ultrasoundguide TAP-catheter|All patients receive bilateral ultrasound guided TAP-catheter and bolus injections of bupivacain 2.5 mg/mL with epinephrin 5 µg/mL every 12 hours in both catheters
800794|NCT01395017|B3|Baseline|Total|Total of all reporting groups
800795|NCT01395017|B2|Baseline|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
800796|NCT01395017|B1|Baseline|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
800797|NCT01395017|P2|Participant Flow|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
800798|NCT01395017|P1|Participant Flow|Dasatinib + GEM|GEM 1000 mg/m2 by intravenous (IV) infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth once daily (QD).
800799|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
800800|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD.
800801|NCT01395017|O2|Outcome|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
800802|NCT01395017|O1|Outcome|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
800803|NCT01395017|E2|Reported Event|Placebo + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus matched placebo by mouth QD.
800804|NCT01395017|E1|Reported Event|Dasatinib + GEM|GEM 1000 mg/m2 by IV infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg by mouth QD
800805|NCT01394991|B3|Baseline|Total|Total of all reporting groups
800806|NCT01394991|B2|Baseline|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800807|NCT01394991|B1|Baseline|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800808|NCT01394991|P2|Participant Flow|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800809|NCT01394991|P1|Participant Flow|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800810|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800811|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800812|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800813|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800814|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800815|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800816|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800817|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800818|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800819|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800820|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800821|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800822|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800823|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800824|NCT01394991|O2|Outcome|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800825|NCT01394991|O1|Outcome|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800826|NCT01394991|E2|Reported Event|Epoetin Alfa TIW|epoetin alfa at an initial dosage of 150 IU/kg 3 times a week (TIW)
800827|NCT01394991|E1|Reported Event|Epoetin Alfa QW|epoetin alfa at an initial dosage of 450 IU/kg once a week (QW)
800828|NCT01394926|B1|Baseline|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
800829|NCT01394926|P1|Participant Flow|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
800830|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post dose level 2.
800831|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL Optison at Time 6.5 Minutes|Dose Level 2: Injection given of 0.5mL of Optison at 6.5 minutes post dose level 1.
800832|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1: Injection of 0.15mL Optison at time 0.
800833|NCT01394926|O3|Outcome|Dose Level 3: 1.5mL Optison 8 Minutes|Dose Level 3: Injection of 1.5mL of Optison 8 minutes post level 2.
800834|NCT01394926|O2|Outcome|Dose Level 2: 0.5mL of Optsion at Time 6.5 Minutes|Dose Level 2: Inj. of 0.5mL Optsion at time 6.5 minutes post dose level 1.
800835|NCT01394926|O1|Outcome|Dose Level 1: Injection of 0.15mL Optison at Time 0.|Dose Level 1 given as an Injection of 0.15mL of Optison at time 0.
800836|NCT01394926|E1|Reported Event|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
800837|NCT01394718|B3|Baseline|Total|Total of all reporting groups
800838|NCT01394718|B2|Baseline|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
800839|NCT01394718|B1|Baseline|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
800840|NCT01394718|P2|Participant Flow|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
800841|NCT01394718|P1|Participant Flow|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
800842|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
800843|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
800844|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
800845|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
800846|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
800847|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
800848|NCT01394718|O2|Outcome|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
800849|NCT01394718|O1|Outcome|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
800850|NCT01394718|E2|Reported Event|Intravenous Acetaminophen|"Subjects will receive the first dose of intravenous (IV) acetaminophen (at 15 mg/kg, with maximum doses based on patient age and weight) at the time of skin closure intra-operatively and will continue to receive IV acetaminophen for 42 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Intravenous Acetaminophen: Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively."
800851|NCT01394718|E1|Reported Event|Saline Placebo|"Control subjects will receive saline as placebo at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).~Placebo: Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses)."
800852|NCT01394692|B3|Baseline|Total|Total of all reporting groups
800853|NCT01394692|B2|Baseline|Conventional Group|standard microsurgical tumor resection
800854|NCT01394692|B1|Baseline|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
800855|NCT01394692|P2|Participant Flow|Conventional Group|standard microsurgical tumor resection
800856|NCT01394692|P1|Participant Flow|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
800857|NCT01394692|O2|Outcome|Conventional Group|standard microsurgical tumor resection
800858|NCT01394692|O1|Outcome|Intraoperative MRI|tumor resection with intraoperative MRI-guidance
800862|NCT01394614|B2|Baseline|Unexposed Narcoleptic Subjects|Unexposed (non-vaccinated or vaccinated after onset of symptoms) narcoleptic subjects to adjuvanted A/H1N1 vaccine
800863|NCT01394614|B1|Baseline|Exposed Narcoleptic Subjects|Exposed (vaccinated and onset of narcolepsy is after vaccine administration) narcoleptic subjects to adjuvanted A/H1N1 vaccine
800973|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800865|NCT01394614|P1|Participant Flow|Narcoleptic Subjects Exposed to Vaccine|Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is after vaccine administration)
800866|NCT01394614|O2|Outcome|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
800867|NCT01394614|O1|Outcome|Exposed Narcoleptic Subjects|"Exposed (vaccinated and onset of narcolepsy is post-vaccination) narcoleptic subjects~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine Arepanrix."
800868|NCT01394614|E2|Reported Event|Unexposed Narcoleptic Subjects|Unexposed narcoleptic subjects (non-vaccinated or vaccinated after onset of symptoms)
800869|NCT01394614|E1|Reported Event|Exposed Narcoleptic Subjects|"Exposed narcoleptic subjects (vaccinated and onset of narcolepsy is post-vaccination)~Intervention: Adjuvanted (ASO3) A/H1N1 pandemic vaccine (Arepanrix)"
800870|NCT01394276|B1|Baseline|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800871|NCT01394276|P1|Participant Flow|Tocilizumab|Participants with moderate to severe Rheumatoid arthritis (RA) who had received RoActemra [Tocilizumab (TCZ)] treatment for 6 months prior to initiation of study and are inadequate responders to Disease Modifying Anti-Rheumatic Drugs (DMARDs) and anti-Tumor Necrosis Factors (anti-TNFs) agents were observed. Participants received treatment with TCZ with dose of 8 milligrams per kilogram (mg/kg) body weight, intravenously once every 4 weeks for 12 months according to European Union (EU) approved dosage, and Summary of Product Characteristics (SmPC).
800872|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800873|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800874|NCT01394276|O2|Outcome|DMARD + Anti-TNF- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800875|NCT01394276|O1|Outcome|DMARD- IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800876|NCT01394276|O2|Outcome|DMARD + Anti-TNF-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800877|NCT01394276|O1|Outcome|DMARD-IR|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800878|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800879|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents. Participants receiving treatment with TCZ with dose of 8 milligrams mg/kg body weight, intravenously once every 4 weeks for 12 months were observed. Dosage of TCZ was prescribed according to EU approved dosage, and SmPC.
800880|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800881|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800882|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800883|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800960|NCT01393899|B3|Baseline|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
801169|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
800884|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800976|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800885|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800886|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800887|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800888|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800889|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800890|NCT01394276|O1|Outcome|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800891|NCT01394276|E1|Reported Event|Tocilizumab|Participants with moderate to severe RA who had received TCZ treatment for 6 months prior to initiation of study and are inadequate responders to DMARDs and anti-TNFs agents were observed. Participants received treatment with TCZ with dose of 8 mg/kg body weight, intravenously once every 4 weeks for 12 months according to EU approved dosage, and SmPC.
800892|NCT01394250|B3|Baseline|Total|Total of all reporting groups
800893|NCT01394250|B2|Baseline|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
800894|NCT01394250|B1|Baseline|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
800895|NCT01394250|P2|Participant Flow|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
800896|NCT01394250|P1|Participant Flow|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
800897|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
800898|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
800899|NCT01394250|O2|Outcome|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
800900|NCT01394250|O1|Outcome|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
800901|NCT01394250|E2|Reported Event|Topical Lidocaine 4% Cream|Topical Lidocaine 4% Cream was applied prior to intravenous cannulation.
800902|NCT01394250|E1|Reported Event|Buzzy®|Buzzy® device was applied prior to intravenous cannulation.
800903|NCT01394159|B3|Baseline|Total|Total of all reporting groups
800904|NCT01394159|B2|Baseline|FNA Needle|FNA: Acquire tissue with FNA needle
800905|NCT01394159|B1|Baseline|ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
800906|NCT01394159|P2|Participant Flow|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
800907|NCT01394159|P1|Participant Flow|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
800908|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
800909|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
800910|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
800911|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
800912|NCT01394159|O2|Outcome|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
800913|NCT01394159|O1|Outcome|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
800914|NCT01394159|E2|Reported Event|22G FNA Needle|Acquire tissue with 22 gauge fine needle aspiration needle
800915|NCT01394159|E1|Reported Event|22G ProCore Biopsy|"Acquire biopsy with procore needle~Procore Biopsy: Acquire tissue with procore biopsy needle"
800916|NCT01393964|B4|Baseline|Total|Total of all reporting groups
800917|NCT01393964|B3|Baseline|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800961|NCT01393899|B2|Baseline|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800962|NCT01393899|B1|Baseline|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800974|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800975|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800918|NCT01393964|B2|Baseline|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800919|NCT01393964|B1|Baseline|Elotuzumab + LD in Normal Renal Function (NRF) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800920|NCT01393964|P3|Participant Flow|Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.
800921|NCT01393964|P2|Participant Flow|Elotuzumab + LD in Severe Renal Impairment(SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl < 30 ml/min but no dialysis.
800922|NCT01393964|P1|Participant Flow|Elotuzumab + LD in Normal Renal Function(NRF) Participants|Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).
800923|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800924|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800925|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800963|NCT01393899|P3|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800964|NCT01393899|P2|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800965|NCT01393899|P1|Participant Flow|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800926|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800927|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800928|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800929|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800930|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800931|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800932|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800933|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800966|NCT01393899|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800967|NCT01393899|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800968|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800934|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800935|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800936|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800937|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800938|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800939|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800940|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800941|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800969|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800970|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800942|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800943|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800944|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800945|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800946|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800947|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800948|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800949|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800971|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800972|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800950|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialysis.
800951|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800952|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Treatment was administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800953|NCT01393964|O3|Outcome|Elotuzumab + LD in End Stage Renal Disease (ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD= requires hemodialyis.
800954|NCT01393964|O2|Outcome|Elotuzumab + LD in Severe Renal Impairment (SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI= estimated CrCl < 30 ml/min but no dialysis.
800955|NCT01393964|O1|Outcome|Elotuzumab + LD in Normal Renal Function (NRF) Participants|LD=Combination of lenalidomide and dexamethasone. Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle. Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF =CrCl ≥ 90 milliliters per minute (mL/min).
800956|NCT01393964|E3|Reported Event|Elotuzumab + LD in End Stage Renal Disease(ESRD) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly as a 40mg PO dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. ESRD = requires hemodialysis.
800957|NCT01393964|E2|Reported Event|Elotuzumab + LD in Severe Renal Impairment(SRI) Participants|Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg IV was administered on Day 1 only for Cycle 1, weekly for Cycles 2 and 3, and Q2W beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on CrCl calculated using the C-G formula based on Day 1 creatinine and Day 1 weight measured at each cycle(per product label). Dexamethasone was administered weekly PO as 40mg dose on weeks without elotuzumab; and as a split dose of 28 mg PO 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G CrCl Method was used to determine renal function. SRI = estimated CrCl < 30 ml/min but no dialysis
800958|NCT01393964|E1|Reported Event|Elotuzumab + LD in Normal Renal Function(NRF) Participants|Combination of lenalidomide and dexamethasone (LD). Elotuzumab + LD were administered in 28 day cycles: Elotuzumab 10 mg/kg intravenous (IV) was administered on Day 1 only for Cycle 1, weekly (Days 1, 8, 15, 22) for Cycles 2 and 3, and every 2 weeks (Q2W) beginning with Cycle 4 and thereafter until disease progression, discontinuation due to unacceptable toxicity, or other protocol-specified reasons. Lenalidomide dosing was based on creatinine clearance (CrCl) calculated using the Cockcroft-Gault (C-G) formula based on Day 1 creatinine and Day 1 weight measured at each cycle (per product label). Dexamethasone was administered weekly as a 40mg oral dose (po) on weeks without elotuzumab; and as a split dose of 28 mg po 3 to 24 hours before and 8 mg IV at least 45 minutes before the start of the elotuzumab infusion on weeks with elotuzumab. C-G Creatinine Clearance CrCl Method was used to determine renal function. NRF = CrCl ≥ 90 milliliters per minute (mL/min).
800959|NCT01393899|B4|Baseline|Total|Total of all reporting groups
800977|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800978|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800979|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800980|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800981|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800982|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800983|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800984|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800985|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800986|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800987|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800988|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800989|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800990|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800991|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800992|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800993|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800994|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800995|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800996|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
800997|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
800998|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
800999|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
801000|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
801001|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
801002|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
801003|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
801004|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
801005|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
801006|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
801007|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
801008|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
801009|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
801010|NCT01393899|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
801011|NCT01393899|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
801012|NCT01393899|O1|Outcome|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
801013|NCT01393899|E3|Reported Event|Tofacitinib 10 mg BID|Tofacitinib 10 mg (two tofacitinib tablets) for oral administration at a dose of 10 mg BID for 26 weeks.
801014|NCT01393899|E2|Reported Event|Tofacitinib 5 mg BID|Tofacitinib 5 mg (one placebo tablet and one tofacitinib tablet) for oral administration at a dose of 5 mg BID for 26 weeks.
801015|NCT01393899|E1|Reported Event|Placebo|Placebo (two placebo tablets) to match tofacitinib for oral administration BID for 26 weeks.
801016|NCT01393743|B3|Baseline|Total|Total of all reporting groups
801111|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
801017|NCT01393743|B2|Baseline|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801018|NCT01393743|B1|Baseline|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801115|NCT01393626|O3|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801019|NCT01393743|P2|Participant Flow|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801020|NCT01393743|P1|Participant Flow|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801021|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801022|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801023|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801024|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801025|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801026|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801027|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801028|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801029|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801030|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801031|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801032|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801033|NCT01393743|O2|Outcome|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801034|NCT01393743|O1|Outcome|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801035|NCT01393743|E2|Reported Event|Perampanel (Core Study)|Participants received 6 tablets (initially ,1 tablet of 2 mg perampanel plus 5 tablets of perampanel matched placebo) and up-titrated weekly in 2 mg increments to a target dose range of 8 mg per day maintaining the blind with administration of 6 tablets per day of either perampanel/perampanel matched placebo.
801036|NCT01393743|E1|Reported Event|Placebo (Core Study)|Participants received 6 tablets of perampanel matched placebo, once a day.
801037|NCT01393730|B1|Baseline|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801038|NCT01393730|P1|Participant Flow|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801039|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801040|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801041|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801042|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801112|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801043|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801116|NCT01393626|O2|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801044|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801045|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801046|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801047|NCT01393730|O1|Outcome|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801048|NCT01393730|E1|Reported Event|Abiraterone + Prednisone + Dutasteride|"Abiraterone acetate + prednisone for two months, followed by abiraterone + prednisone + dutasteride in 28-day cycles until symptomatic or radiographic progression~Abiraterone acetate: 1000 mg orally, once per day~Dutasteride: 3.5 mg orally once per day~Prednisone: 5 mg orally once per day"
801049|NCT01393704|B3|Baseline|Total|Total of all reporting groups
801050|NCT01393704|B2|Baseline|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801051|NCT01393704|B1|Baseline|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801052|NCT01393704|P2|Participant Flow|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801053|NCT01393704|P1|Participant Flow|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801054|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801055|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801056|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801057|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801058|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801059|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801060|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801061|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801062|NCT01393704|O2|Outcome|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801063|NCT01393704|O1|Outcome|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801064|NCT01393704|E2|Reported Event|Low Volume Dilute Vasopressin|"20 units Vasopressin diluted in 60 mL of Normal Saline, inject 30 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801065|NCT01393704|E1|Reported Event|High Volume Dilute Vasopressin|"20 units Vasopressin diluted in 400 mL of Saline, inject 200 mL total of the dilute Vasopressin solution in subserosal location overlying fibroid (total 10 units Vasopressin used).~Vasopressin: Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy."
801066|NCT01393626|B5|Baseline|Total|Total of all reporting groups
801067|NCT01393626|B4|Baseline|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801068|NCT01393626|B3|Baseline|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801069|NCT01393626|B2|Baseline|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801070|NCT01393626|B1|Baseline|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801071|NCT01393626|P4|Participant Flow|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801072|NCT01393626|P3|Participant Flow|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801073|NCT01393626|P2|Participant Flow|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801074|NCT01393626|P1|Participant Flow|Placebo|Placebo tablets to match tofacitinib 5 milligrams (mg) for oral administration twice daily (BID) for 8 weeks.
801075|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801076|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801077|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801078|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
801079|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801080|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801081|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801082|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801083|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801084|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801085|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
801086|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801087|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801088|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801089|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801090|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801091|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801092|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks (N=16).
801093|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801094|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801095|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801096|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801097|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801098|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801099|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801100|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801101|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801102|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801103|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801104|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801105|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801106|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801107|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801108|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks (N=86).
801109|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801110|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801165|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801113|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks (N=85).
801114|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks (N=90).
801117|NCT01393626|O1|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801118|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801119|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801120|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801121|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801122|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801123|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801124|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801125|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801126|NCT01393626|O4|Outcome|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801127|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801128|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801129|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801130|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801131|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801132|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801133|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801134|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801135|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801136|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801137|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801138|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801139|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801140|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801141|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801142|NCT01393626|O3|Outcome|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801143|NCT01393626|O2|Outcome|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801144|NCT01393626|O1|Outcome|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801145|NCT01393626|E4|Reported Event|Tofacitinib 15 mg BID|Tofacitinib tablets for oral administration at a dose of 15 mg BID for 8 weeks.
801146|NCT01393626|E3|Reported Event|Tofacitinib 10 mg BID|Tofacitinib tablets for oral administration at a dose of 10 mg BID for 8 weeks.
801147|NCT01393626|E2|Reported Event|Tofacitinib 5 mg BID|Tofacitinib tablets for oral administration at a dose of 5 mg BID for 8 weeks.
801148|NCT01393626|E1|Reported Event|Placebo|Placebo tablets to match tofacitinib 5 mg for oral administration BID for 8 weeks.
801149|NCT01393613|B5|Baseline|Total|Total of all reporting groups
801150|NCT01393613|B4|Baseline|Placebo|Placebo tablet once daily for 6 weeks.
801151|NCT01393613|B3|Baseline|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801152|NCT01393613|B2|Baseline|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801153|NCT01393613|B1|Baseline|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801154|NCT01393613|P4|Participant Flow|Placebo|Placebo tablet once daily for 6 weeks.
801155|NCT01393613|P3|Participant Flow|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801156|NCT01393613|P2|Participant Flow|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801157|NCT01393613|P1|Participant Flow|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801158|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801159|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801160|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801161|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801162|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks. Participants were titrated to the target dose of placebo over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
801163|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks. Participants were titrated to the target dose of brexpiprazole over a 1-week period beginning at the randomization (Day 1), and all participants were to have achieved the assigned dose the day after the Week 1 visit (ie, the beginning of Week 2).
801164|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801170|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801171|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801172|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801173|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801174|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801178|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801179|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801180|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801181|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801182|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801183|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801184|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801185|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801186|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801187|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801188|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801189|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801190|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801191|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801192|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801193|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801194|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801195|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801196|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801197|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801198|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801199|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801200|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801201|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801202|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801203|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801204|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801205|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801206|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801207|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801208|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801209|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801210|NCT01393613|O4|Outcome|Placebo|Placebo tablet once daily for 6 weeks.
801211|NCT01393613|O3|Outcome|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801212|NCT01393613|O2|Outcome|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801213|NCT01393613|O1|Outcome|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801214|NCT01393613|E4|Reported Event|Placebo|Placebo tablet once daily for 6 weeks.
801215|NCT01393613|E3|Reported Event|Brexpiprazole 4 mg|Brexpiprazole 4 mg tablet once daily for 6 weeks.
801216|NCT01393613|E2|Reported Event|Brexpiprazole 2 mg|Brexpiprazole 2 mg tablet once daily for 6 weeks.
801217|NCT01393613|E1|Reported Event|Brexpiprazole 1 mg|Brexpiprazole 1 mg tablet once daily for 6 weeks.
801218|NCT01393444|B1|Baseline|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
801219|NCT01393444|P1|Participant Flow|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
801220|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
801221|NCT01393444|O1|Outcome|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
801222|NCT01393444|E1|Reported Event|Direct Brain Interface Users|"All participants enrolled in the study will undergo Implantation of ECoG sensors on the brain surface to record neural activity. There is no control group. There are no other arms.~Implantation of ECoG sensors on the brain surface: One ECoG sensor will be implanted over the motor cortex of study participants"
801223|NCT01393132|B3|Baseline|Total|Total of all reporting groups
801355|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801224|NCT01393132|B2|Baseline|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801225|NCT01393132|B1|Baseline|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801226|NCT01393132|P2|Participant Flow|Placebo|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days."
801706|NCT01391858|P1|Participant Flow|Pregabalin|Pregabalin 300 mg 1-2 hrs. before the surgery and then 150 mg twice a day for 14 days
801227|NCT01393132|P1|Participant Flow|Thymosin|"Arm/Group * Reporting Groups Definition: Arms or comparison groups in a trial~Description Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.~Period Title * Participant Flow: Overall Study~Placebo Thymosin Beta 4 Started 3 6 Completed 3 6"
801228|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801229|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801230|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801231|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801232|NCT01393132|O2|Outcome|Placebo|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801233|NCT01393132|O1|Outcome|Thymosin|"Comparison~Thymosin Beta 4 eye drops vs. vehicle: Patients will be randomized and will receive either Thymosin Beta 4 eye drops or the same eye drops without the Thymosin Beta 4."
801234|NCT01393132|O2|Outcome|Placebo|Placebo : A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
801235|NCT01393132|O1|Outcome|Thymosin|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
801236|NCT01393132|E2|Reported Event|Placebo|: A preservative-free, sterile eye drop solution not including Tβ4 for direct instillation into each eye, six times daily for 28 days
801237|NCT01393132|E1|Reported Event|Thymosin Beta 4|Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, six times daily for 28 days.
801238|NCT01393106|B1|Baseline|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801239|NCT01393106|P1|Participant Flow|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801240|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801241|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801242|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801243|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801244|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801245|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801246|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801247|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801248|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801249|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801250|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801251|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801252|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801253|NCT01393106|O1|Outcome|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801254|NCT01393106|E1|Reported Event|Idelalisib|Idelalisib up to 300 mg (75, 100, or 150 mg tablets) administered orally twice daily until tumor progression or development of unacceptable toxicity.
801255|NCT01392742|B1|Baseline|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801256|NCT01392742|P1|Participant Flow|Hepatitis C Virus (HCV) Infected Participants|Participants who were infected by HCV and receiving pegylated interferon alfa-2a (PEG-IFN alfa-2a) 180 micrograms per week (µg/week) subcutaneously, plus ribavirin tablets 1000 milligrams (mg) (those weighing less than [<] 75 kilograms [kg]) or 1200 mg (those weighing greater than [>] 75 kg) orally; were observed for approximately up to 24 weeks after end of treatment (EOT). Dose change was as per investigators’ discretion.
801543|NCT01392326|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
801707|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801257|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801258|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801259|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801260|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801261|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801262|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801263|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801264|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801265|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801266|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801267|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801268|NCT01392742|O1|Outcome|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately up to 24 weeks after EOT. Dose change was as per investigators’ discretion.
801269|NCT01392742|E1|Reported Event|HCV Infected Participants|Participants who were infected by HCV and receiving PEG-IFN alfa-2a 180 µg/week subcutaneously, plus ribavirin tablets 1000 mg (those weighing <75 kg) or 1200 mg (those weighing > 75 kg) orally; were observed for approximately 24 weeks. Dose change was as per investigators’ discretion.
801270|NCT01392703|B1|Baseline|All Treated|
801271|NCT01392703|P3|Participant Flow|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801272|NCT01392703|P2|Participant Flow|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801273|NCT01392703|P1|Participant Flow|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801274|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801275|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801356|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801276|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801277|NCT01392703|O1|Outcome|All Treated|
801544|NCT01392326|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg. After week 24 all placebo non responders were re-randomized to either 75 mg or 150 mg 1:1 to complete the trial
801278|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801279|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801280|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801281|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801282|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801283|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801284|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801285|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801286|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801287|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801288|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period..
801289|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801290|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801291|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801292|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801293|NCT01392703|O3|Outcome|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801294|NCT01392703|O2|Outcome|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801295|NCT01392703|O1|Outcome|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801357|NCT01392495|E2|Reported Event|QTI571 400mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801358|NCT01392495|E1|Reported Event|QTI571 200mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801296|NCT01392703|E3|Reported Event|Dasatinib, 100 mg as Tablets in Orange Juice + Water|Treatment C: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets dispersed in 30 mL of 100% orange juice, followed by 15 mL of orange juice as a rinsing solution plus 195 mL noncarbonated, nonrefrigerated water. All doses were administered in the fasted state.
801297|NCT01392703|E2|Reported Event|Dasatinib, 100 mg as Liquid + Water|Treatment B: Participants received a single oral dose of dasatinib, 100 mg, administered as 10 mL of reconstituted suspension of dasatinib powder for oral suspension (10 mg dasatinib/mL) with 230 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801298|NCT01392703|E1|Reported Event|Dasatinib, 100 mg as Tablets + Water|Treatment A: Participants received a single oral dose of dasatinib, 100 mg, administered as 2 50-mg tablets, plus 240 mL of noncarbonated, nonrefrigerated water. All doses were administered in the fasted state. A 3-day washout period followed the treatment period.
801299|NCT01392677|B3|Baseline|Total|Total of all reporting groups
801300|NCT01392677|B2|Baseline|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801301|NCT01392677|B1|Baseline|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801302|NCT01392677|P2|Participant Flow|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801303|NCT01392677|P1|Participant Flow|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801304|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801305|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801306|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801307|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801308|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801309|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801310|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801311|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801312|NCT01392677|O2|Outcome|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801313|NCT01392677|O1|Outcome|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801314|NCT01392677|E2|Reported Event|Dapagliflozin 10mg Plus Metformin Plus Sulfonylurea|Dapagliflozin 10mg once daily plus background combination of metformin and sulfonylurea
801315|NCT01392677|E1|Reported Event|Placebo Plus Metformin Plus Sulfonylurea|Placebo once daily plus background combination of metformin and sulfonylurea
801316|NCT01392573|B3|Baseline|Total|Total of all reporting groups
801317|NCT01392573|B2|Baseline|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
801318|NCT01392573|B1|Baseline|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
801319|NCT01392573|P2|Participant Flow|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
801320|NCT01392573|P1|Participant Flow|IDegLira|Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
801321|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
801322|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
801359|NCT01392378|B6|Baseline|Total|Total of all reporting groups
801800|NCT01391559|E1|Reported Event|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
801545|NCT01392300|B3|Baseline|Total|Total of all reporting groups
801546|NCT01392300|B2|Baseline|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801323|NCT01392573|O2|Outcome|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
801324|NCT01392573|O1|Outcome|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
801325|NCT01392573|E2|Reported Event|IDeg|Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0−5.0 mmol/L).
801326|NCT01392573|E1|Reported Event|IDegLira|IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
801327|NCT01392560|B1|Baseline|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
801328|NCT01392560|P1|Participant Flow|Empagliflozin (BI 10773) 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
801329|NCT01392560|O3|Outcome|Non-hyperfilterers (Empagliflozin 25 mg)|"Non-hyperfilterers~Empagliflozin 25 mg: Oral once daily~non-hyperfilterers = GFRs of ≥60 mL/min/1.73m2 to <135 mL/min/1.73m2"
801330|NCT01392560|O2|Outcome|Hyperfilterers (Empagliflozin 25 mg)|"Hyperfilterers~Empagliflozin 25 mg: Oral once daily~hyperfilterers = GFRs of ≥135 mL/min/1.73m2"
801331|NCT01392560|O1|Outcome|All Patients (Empagliflozin 25 mg)|"All patients (hyperfilterers and non-hyperfilterers)~Empagliflozin 25 mg: Oral once daily"
801332|NCT01392560|E1|Reported Event|Empagliflozin 25 mg|"Oral once daily~Empagliflozin 25 mg: Oral once daily"
801333|NCT01392547|B1|Baseline|Vatrepcacog Alfa and rFVIIa|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner.
801334|NCT01392547|P1|Participant Flow|Vatreptacog Alfa and rFVIIa (All Subjects)|Subjects participating in the trial were randomised to receive vatreptacog alfa and rFVIIa in a cross-over manner. Subjects participating in the trial had bleeding episodes randomised to treatment with either vatraptacog alfa or rFVIIa in an independent manner for each bleeding episodes. Of the 72 subjects, 3 subjects did not have any bleeds.
801335|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
801336|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
801337|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
801338|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
801339|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
801340|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
801341|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
801342|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
801343|NCT01392547|O2|Outcome|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
801344|NCT01392547|O1|Outcome|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
801345|NCT01392547|E2|Reported Event|rFVIIa 90 µg/kg|Recombinant factor VIIa (rFVIIa) was administered intravenous bolus, 1−3 doses 90 µg/kg body weight until haemostasis was achieved for a bleed
801346|NCT01392547|E1|Reported Event|Vatreptacog Alfa 80 µg/kg|Vatreptacog alfa was administered intravenous bolus, 1−3 doses at 80 µg/kg body weight until haemostasis was achieved for a bleed
801347|NCT01392495|B1|Baseline|QTI571|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801348|NCT01392495|P1|Participant Flow|QTI571|Participants received 200 mg or 400 mg every day (qd) based on their highest tolerated dose in CQTI571A2102 (NCT01392469).
801349|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801350|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801351|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801352|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801353|NCT01392495|O2|Outcome|QTI571 400 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801354|NCT01392495|O1|Outcome|QTI571 200 mg|Participants received 200 mg or 400 mg qd based on their highest tolerated dose in CQTI571A2102.
801801|NCT01391507|B5|Baseline|Total|Total of all reporting groups
801360|NCT01392378|B5|Baseline|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801361|NCT01392378|B4|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801362|NCT01392378|B3|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801363|NCT01392378|B2|Baseline|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801364|NCT01392378|B1|Baseline|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801365|NCT01392378|P5|Participant Flow|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801366|NCT01392378|P4|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801367|NCT01392378|P3|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801368|NCT01392378|P2|Participant Flow|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801369|NCT01392378|P1|Participant Flow|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801370|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801371|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801372|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801425|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801373|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801374|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801375|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801376|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801377|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801378|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801379|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801380|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801381|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801382|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801383|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801384|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801385|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801465|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801386|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801387|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801388|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801389|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801390|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801391|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801392|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801393|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801394|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801395|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801396|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801397|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801398|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801514|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801515|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801516|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801517|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801399|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801400|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801401|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801402|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801403|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801404|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801405|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801406|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801407|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801408|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801409|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801410|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801411|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801518|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801519|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801520|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801521|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801522|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801412|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801413|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801414|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801415|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801416|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801417|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801418|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801419|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801420|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801421|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801422|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801423|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801424|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801523|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801524|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801525|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801426|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801427|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801428|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801429|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801430|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801431|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801432|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801433|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801434|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801435|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801436|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801437|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801438|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801526|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801527|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801528|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801529|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801439|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801440|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801441|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801442|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801443|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801444|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801445|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801446|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801447|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801448|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801449|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801450|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801451|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801530|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801531|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801532|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801533|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801534|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801452|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801453|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801454|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801455|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801456|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801457|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801458|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801459|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801460|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801461|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801462|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801463|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801464|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801535|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801536|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801537|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801466|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801467|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801468|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801469|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801470|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801471|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801472|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801473|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801474|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801475|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801476|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801477|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801478|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801538|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801539|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801540|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801541|NCT01392326|O1|Outcome|Group 1|Secukinumab (75mg)
801479|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801480|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801481|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801482|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801483|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801484|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801485|NCT01392378|O5|Outcome|13vPnC + INFANRIX Hexa|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age.
801486|NCT01392378|O4|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen.
801487|NCT01392378|O3|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Thrice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol.
801488|NCT01392378|O2|Outcome|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily|Participants received open-label 0.5 mL dose of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (>=56 to <=98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of ibuprofen.
801489|NCT01392378|O1|Outcome|13vPnC + INFANRIX Hexa + Paracetamol Twice Daily|Participants received open-label 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 2 months (greater than or equal to [>=]56 to less than or equal to [<=]98 days of age), 3 months (28 to 42 days after Dose 1), 4 months (28 to 42 days after Dose 2, infant series) and 11 to 12 months (366 to 425 days of age, toddler dose) of age, along with paracetamol suspension 15 milligram per kilogram (mg/kg) orally at 6 to 8 hours after each vaccination and 6 to 8 hours after first dose of paracetamol.
801490|NCT01392378|E15|Reported Event|13vPnC + INFANRIX Hexa - Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
801491|NCT01392378|E14|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
801542|NCT01392326|E3|Reported Event|Placebo|Placebo. After week 24, only reponders continued to receive placebo to the end of the trial.
801492|NCT01392378|E13|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Thrice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
801493|NCT01392378|E12|Reported Event|13vPnC +INFANRIX Hexa + Ibuprofen Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
801494|NCT01392378|E11|Reported Event|13vPnC +INFANRIX Hexa + Paracetamol Twice Daily -Toddler Dose|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series and toddler dose (0.5 mL) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions at 366 to 425 days of age, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from the toddler dose through the blood draw 28 to 42 days post toddler dose.
801495|NCT01392378|E10|Reported Event|13vPnC + INFANRIX Hexa - After Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, assessed after the infant series blood draw up to toddler dose.
801496|NCT01392378|E9|Reported Event|13vPnC +INFANRIX Hexa +Ibuprofen Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
801497|NCT01392378|E8|Reported Event|13vPnC+INFANRIX Hexa +Paracetamol Thrice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
801498|NCT01392378|E7|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed after the infant series blood draw up to toddler dose.
801499|NCT01392378|E6|Reported Event|13vPnC +INFANRIX Hexa +Paracetamol Twice Daily -After Inf Ser|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series (Inf Ser), along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed after the infant series blood draw up to toddler dose.
801500|NCT01392378|E5|Reported Event|13vPnC + INFANRIX Hexa - Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series (Inf Ser).
801501|NCT01392378|E4|Reported Event|13vPnC+ INFANRIX Hexa+ Ibuprofen Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
801502|NCT01392378|E3|Reported Event|13vPnC+INFANRIX Hexa+Paracetamol Thrice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with paracetamol suspension 15 mg/kg orally immediately after vaccination, 6 to 8 hours after vaccination and 6 to 8 hours after last dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
801503|NCT01392378|E2|Reported Event|13vPnC + INFANRIX Hexa + Ibuprofen Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart, along with ibuprofen suspension 10 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of ibuprofen, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
801504|NCT01392378|E1|Reported Event|13vPnC+ INFANRIX Hexa +Paracetamol Twice Daily -Infant Series|Participants who received 3 open-label doses (0.5 mL each) of 13vPnC intramuscularly and INFANRIX hexa intramuscularly as per manufacturer’s instructions 28 to 42 days apart in infant series, along with paracetamol suspension 15 mg/kg orally at 6 to 8 hours after vaccination and 6 to 8 hours after first dose of paracetamol, assessed from Infant series Dose 1 through the blood draw 28 to 42 days post infant series.
801505|NCT01392326|B4|Baseline|Total|Total of all reporting groups
801506|NCT01392326|B3|Baseline|Group 3|Placebo match (for 75 and 150 mg)
801507|NCT01392326|B2|Baseline|Group 2|Secukinumab (150 mg)
801508|NCT01392326|B1|Baseline|Group 1|Secukinumab (75mg)
801509|NCT01392326|P3|Participant Flow|Placebo Match for AIN457 ( 75 and 150 mg)|Placebo match (for 75 and 150 mg)
801510|NCT01392326|P2|Participant Flow|AIN457 (150 mg)|Secukinumab (150 mg)
801511|NCT01392326|P1|Participant Flow|AIN457 (75 mg)|Secukinumab (75mg)
801512|NCT01392326|O3|Outcome|Group 3|Placebo match (for 75 and 150 mg)
801513|NCT01392326|O2|Outcome|Group 2|Secukinumab (150 mg)
801547|NCT01392300|B1|Baseline|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801548|NCT01392300|P3|Participant Flow|OLEX IncobotulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
801549|NCT01392300|P2|Participant Flow|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801550|NCT01392300|P1|Participant Flow|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801551|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801552|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801553|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801554|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801555|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801556|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801557|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801558|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801559|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801560|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801561|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801562|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801563|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801564|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801565|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801566|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801567|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801568|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801569|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801570|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801571|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801572|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801573|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801574|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801575|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801576|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801577|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
802570|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
801578|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801579|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801580|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801581|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801582|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801583|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801584|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801585|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801586|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801587|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801588|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801589|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801590|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801591|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801592|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801593|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801594|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801595|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801596|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801597|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801598|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801599|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801600|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801601|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801602|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801603|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801604|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801605|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801606|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801607|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801608|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801609|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801610|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801611|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801612|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801613|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801614|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801615|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801616|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801617|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801618|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801619|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801620|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801621|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801622|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801623|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801624|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801625|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801626|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801627|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801628|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801629|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801630|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801631|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801632|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801633|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801634|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801635|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801636|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801637|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801638|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801639|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801640|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801641|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801642|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801643|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801644|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801645|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801646|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801647|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801648|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801649|NCT01392300|O2|Outcome|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801650|NCT01392300|O1|Outcome|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801651|NCT01392300|E3|Reported Event|OLEX IncoboutulinumtoxinA (Xeomin) (400 Units, 3 Injections)|IncobotulinumtoxinA (Xeomin) (400 Units): OLEX period, three injection sessions - open-label treatment assignment
801652|NCT01392300|E2|Reported Event|Double-blind Placebo Comparator|Placebo to incobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801653|NCT01392300|E1|Reported Event|Double-blind IncobotulinumtoxinA (Xeomin) (400 Units)|IncobotulinumtoxinA (Xeomin) (400 Units): Main period, one injection session - double-blind, randomized treatment assignment
801654|NCT01390259|B1|Baseline|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
801655|NCT01390259|P2|Participant Flow|Closed-Loop Control First, Then Open-Loop|"Closed-Loop control (CLC) first, then Open-Loop~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
801656|NCT01390259|P1|Participant Flow|Open-Loop First, Then Closed-Loop|"Open-Loop first, then Closed-Loop control (CLC)~Experimental, CLC admission: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop admission. The subjects were in charge of their insulin treatment."
801657|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
801658|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
801659|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
801660|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
801661|NCT01390259|O2|Outcome|Open-Loop|"The subjects were in charge of their insulin treatment.~Open-Loop: This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...)."
801698|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801699|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
802571|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
801672|NCT01390233|O2|Outcome|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
801708|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801662|NCT01390259|O1|Outcome|Closed-Loop Control (CLC)|"The CLC used a computer to make recommendations for their insulin treatment. This study arm was designed to demonstrate management of glucose using a modular insulin management system based on continuous glucose monitoring and targeted towards the avoidance of hypoglycemic and prolonged hyperglycemic episodes (i.e. control to range). This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Closed-Loop: During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. Standard Control to Range (sCTR)."
801663|NCT01390259|E1|Reported Event|Adolescents|"Adolescents participated in both the Standard Control to Range (sCTR) Closed-Loop Control (CLC) Admission and the Open-Loop admission.~Experimental: The CLC used a computer to make recommendations for their insulin treatment. This system was designed to both:~monitor the meal boluses of the patient and correct it in case of observed/predicted under insulinization (avoidance of prolonged hyperglycemia), based on a coarse and subjective knowledge of the meal amount, a precise understanding of the subject's day to day insulin treatment, continuous glucose monitoring, and past insulin injections;~predict and avoid hypoglycemic events, based on continuous glucose reading and past insulin injection.~Placebo Comparator: Open Loop. The subjects were in charge of their insulin treatment."
801664|NCT01390233|B4|Baseline|Total|Total of all reporting groups
801665|NCT01390233|B3|Baseline|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
801666|NCT01390233|B2|Baseline|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
801667|NCT01390233|B1|Baseline|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
801668|NCT01390233|P3|Participant Flow|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
801669|NCT01390233|P2|Participant Flow|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
801670|NCT01390233|P1|Participant Flow|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
801671|NCT01390233|O3|Outcome|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
801700|NCT01392053|E2|Reported Event|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801673|NCT01390233|O1|Outcome|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
801674|NCT01390233|E3|Reported Event|Combined Urinary Catheter & Prepadil Gel|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.~Urinary Balloon Catheter Device and Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment."
801675|NCT01390233|E2|Reported Event|Prepadil Only|"Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Dinoprostone Gel: Pre-induction cervical ripening using dinoprostone gel in the vagina."
801676|NCT01390233|E1|Reported Event|Urinary Balloon Catheter Only|"A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.~Urinary Balloon Catheter: Pre-induction cervical ripening using a urinary balloon catheter device."
801677|NCT01392170|B1|Baseline|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
801678|NCT01392170|P1|Participant Flow|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
801679|NCT01392170|O1|Outcome|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
801680|NCT01392170|E1|Reported Event|PEG-IFNá-2a|PEG-IFNá-2a (Pegasys) 45 mcg subcutaneously as single weekly dose.
801681|NCT01392053|B3|Baseline|Total|Total of all reporting groups
801682|NCT01392053|B2|Baseline|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801683|NCT01392053|B1|Baseline|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801684|NCT01392053|P2|Participant Flow|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801685|NCT01392053|P1|Participant Flow|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801686|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801687|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801688|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801689|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801690|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801691|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801692|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801693|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801694|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801695|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801696|NCT01392053|O2|Outcome|Massage Group|Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
801697|NCT01392053|O1|Outcome|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801701|NCT01392053|E1|Reported Event|Control Group|Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group
801702|NCT01391858|B3|Baseline|Total|Total of all reporting groups
801703|NCT01391858|B2|Baseline|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801704|NCT01391858|B1|Baseline|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801705|NCT01391858|P2|Participant Flow|Placebo|Placebo 1-2 hrs. before the surgery and then twice daily for 14 days
801709|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801710|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801711|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801712|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801713|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801714|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801715|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801716|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801717|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801718|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801719|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801720|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801721|NCT01391858|O2|Outcome|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801722|NCT01391858|O1|Outcome|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801723|NCT01391858|E2|Reported Event|Placebo|"placebo~lyrica: 150mg of pregabalin/placebo"
801724|NCT01391858|E1|Reported Event|Pregabalin|"pregabalin (lyrica)~lyrica: 150mg of pregabalin/placebo"
801725|NCT01391819|B1|Baseline|Dengue Group|Subjects, male and female, aged 5-13 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801726|NCT01391819|P1|Participant Flow|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801727|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801728|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801729|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801730|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801731|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801732|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801733|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801734|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801735|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801736|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801737|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801738|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801739|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801740|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801741|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801742|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801743|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801744|NCT01391819|O1|Outcome|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801745|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801746|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801747|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801748|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801749|NCT01391819|O2|Outcome|Dengue 10-17Y Group|Subjects, male and female, aged 10-17 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801750|NCT01391819|O1|Outcome|Dengue 5-9Y Group|Subjects, male and female, aged 5-9 years (Y), enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801751|NCT01391819|E1|Reported Event|Dengue Group|Subjects, male and female, aged 5-13 years at time of enrollment, enrolled for data collection and blood sampling for dengue evaluation, from Day 0 to Year 3.
801753|NCT01391663|B4|Baseline|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801754|NCT01391663|B3|Baseline|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801755|NCT01391663|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801756|NCT01391663|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801757|NCT01391663|P4|Participant Flow|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801758|NCT01391663|P3|Participant Flow|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801759|NCT01391663|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801760|NCT01391663|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801761|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801762|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801763|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801764|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801765|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801766|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801767|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801768|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801769|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801770|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801771|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801772|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801773|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801774|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801775|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801776|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801777|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801778|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801779|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801780|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801781|NCT01391663|O4|Outcome|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801782|NCT01391663|O3|Outcome|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801783|NCT01391663|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801784|NCT01391663|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801785|NCT01391663|E4|Reported Event|Placebo|Placebo tablets, orally, two tablets taken once daily for up to 7 days.
801786|NCT01391663|E3|Reported Event|Alogliptin 50 mg QD|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
801787|NCT01391663|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
801788|NCT01391663|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
801789|NCT01391611|B1|Baseline|Pazopanib Arm|Pazopanib: 800 mg; PO
801790|NCT01391611|P1|Participant Flow|Pazopanib Arm|Pazopanib: 800 mg; PO
801791|NCT01391611|O1|Outcome|Pazopanib Arm|Pazopanib: 800 mg; PO
801792|NCT01391611|O1|Outcome|Pazopanib Arm|Pazopanib: 800 mg; PO
801793|NCT01391611|E1|Reported Event|Pazopanib Arm|Pazopanib: 800 mg; PO
801794|NCT01391559|B1|Baseline|Entire Study Population|Includes groups randomized to receive Arformoterol first and Salmeterol first
801795|NCT01391559|P2|Participant Flow|Salmeterol First, Then Arformoterol|Salmeterol (50 mcg) Diskus in the first intervention, Arformoterol (15 mcg/2 mL) solution via nebulizer in the second intervention
801796|NCT01391559|P1|Participant Flow|Arformoterol First, Then Salmeterol|Arformoterol (15 mcg/2 mL) solution via nebulizer in the first intervention, Salmeterol (50 mcg) Diskus in the second intervention
801797|NCT01391559|O2|Outcome|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
801798|NCT01391559|O1|Outcome|Arformoterol|Arformoterol aerosol solution (15 mcg/2 mL)via nebulizer
801799|NCT01391559|E2|Reported Event|Salmeterol|Salmeterol dry powder (50 mcg) via Diskus
801802|NCT01391507|B4|Baseline|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801803|NCT01391507|B3|Baseline|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801804|NCT01391507|B2|Baseline|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801805|NCT01391507|B1|Baseline|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801806|NCT01391507|P4|Participant Flow|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801807|NCT01391507|P3|Participant Flow|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801808|NCT01391507|P2|Participant Flow|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801809|NCT01391507|P1|Participant Flow|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801810|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801811|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801812|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801813|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801814|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801815|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801816|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801817|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801818|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801819|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801820|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801821|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801822|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801823|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801824|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801825|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801826|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801827|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801828|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801829|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801830|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801831|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801832|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801833|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801834|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801835|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801836|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801837|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801838|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801839|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801840|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801841|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801842|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801843|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801844|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801845|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801846|NCT01391507|O4|Outcome|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801847|NCT01391507|O3|Outcome|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801848|NCT01391507|O2|Outcome|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801849|NCT01391507|O1|Outcome|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801850|NCT01391507|E4|Reported Event|COR-1 160 mg|COR-1 was administered at a dose of 160 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801851|NCT01391507|E3|Reported Event|COR-1 80 mg|COR-1 was administered at a dose of 80 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801852|NCT01391507|E2|Reported Event|COR-1 20 Milligram (mg)|COR-1 (JNJ-54452840) was administered at a dose of 20 mg intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801853|NCT01391507|E1|Reported Event|Placebo|Matching placebo (0.9 percent sodium chloride solution) was administered intravenously in addition to the standard therapy for heart failure every 4 weeks for a total of 6 doses.
801854|NCT01391468|B3|Baseline|Total|Total of all reporting groups
801855|NCT01391468|B2|Baseline|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
801856|NCT01391468|B1|Baseline|Placebo|Cornstarch: placebo will be given in 6 months
801857|NCT01391468|P2|Participant Flow|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
801858|NCT01391468|P1|Participant Flow|Placebo|Cornstarch: placebo will be given in 6 months
801859|NCT01391468|O2|Outcome|Placebo|Plabeco group received maltodextrin for 6 months
801860|NCT01391468|O1|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
801861|NCT01391468|O2|Outcome|Placebo|Placeo group received maltodextrin for 6 months
801862|NCT01391468|O1|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
801863|NCT01391468|O2|Outcome|Probiotics|"probiotics~Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations"
801864|NCT01391468|O1|Outcome|Placebo|"cornstarch~Cornstarch: placebo will be given in 6 months"
801865|NCT01391468|O2|Outcome|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
801866|NCT01391468|O1|Outcome|Placebo|Cornstarch: placebo will be given in 6 months
801867|NCT01391468|E2|Reported Event|Placebo|Cornstarch: placebo will be given in 6 months
801868|NCT01391468|E1|Reported Event|Probiotics|Probiotics: intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
801869|NCT01390181|B1|Baseline|Losartan|Cozaar: Angiotensin II Receptor Blocker
801870|NCT01390181|P1|Participant Flow|Losartan|Cozaar: Angiotensin II Receptor Blocker
801871|NCT01390181|O1|Outcome|Losartan|Cozaar: Angiotensin II Receptor Blocker
801872|NCT01390181|E1|Reported Event|Losartan|Cozaar: Angiotensin II Receptor Blocker
801873|NCT01391325|B1|Baseline|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
801874|NCT01391325|P1|Participant Flow|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
801875|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
801876|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
801877|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
801878|NCT01391325|O1|Outcome|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
801879|NCT01391325|E1|Reported Event|Allopurinol|"Treatment.~Allopurinol: Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label."
801880|NCT01391312|B3|Baseline|Total|Total of all reporting groups
801881|NCT01391312|B2|Baseline|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
801882|NCT01391312|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
801883|NCT01391312|P2|Participant Flow|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
801884|NCT01391312|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
801885|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
801886|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
801887|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
801888|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
801889|NCT01391312|O2|Outcome|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
801890|NCT01391312|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
801891|NCT01391312|E2|Reported Event|Placebo (Normal Saline)|Normal Saline (placebo) injected into the glabellar region on Day 0.
801892|NCT01391312|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
801893|NCT01391299|B4|Baseline|Total|Total of all reporting groups
801894|NCT01391299|B3|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801895|NCT01391299|B2|Baseline|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801896|NCT01391299|B1|Baseline|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801897|NCT01391299|P3|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801898|NCT01391299|P2|Participant Flow|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801899|NCT01391299|P1|Participant Flow|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801900|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801901|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801902|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801903|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801904|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801905|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801906|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801907|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801908|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801909|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801910|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801911|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801912|NCT01391299|O3|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801913|NCT01391299|O2|Outcome|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801914|NCT01391299|O1|Outcome|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801915|NCT01391299|E3|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into bilateral forehead and frown lines areas on Day 1.
801916|NCT01391299|E2|Reported Event|Botulinum Toxin Type A (30 Units)|Botulinum toxin Type A 30 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801917|NCT01391299|E1|Reported Event|Botulinum Toxin Type A (40 Units)|Botulinum toxin Type A 40 Units (total dose) injected into bilateral forehead and frown line areas on Day 1.
801918|NCT01391286|B3|Baseline|Total|Total of all reporting groups
801919|NCT01391286|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801920|NCT01391286|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801921|NCT01391286|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801922|NCT01391286|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801923|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801924|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801925|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801926|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801927|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801928|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801929|NCT01391286|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801930|NCT01391286|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801931|NCT01391286|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801932|NCT01391286|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801933|NCT01391273|B3|Baseline|Total|Total of all reporting groups
801934|NCT01391273|B2|Baseline|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801935|NCT01391273|B1|Baseline|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801936|NCT01391273|P2|Participant Flow|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801937|NCT01391273|P1|Participant Flow|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801938|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801939|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801940|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801941|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801942|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801943|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801944|NCT01391273|O2|Outcome|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801945|NCT01391273|O1|Outcome|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801946|NCT01391273|E2|Reported Event|Bimatoprost Vehicle Solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
801947|NCT01391273|E1|Reported Event|Bimatoprost Solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
801948|NCT01391013|B3|Baseline|Total|Total of all reporting groups
801949|NCT01391013|B2|Baseline|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801950|NCT01391013|B1|Baseline|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801951|NCT01391013|P2|Participant Flow|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801952|NCT01391013|P1|Participant Flow|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801953|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801954|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801955|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801956|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801957|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801958|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801959|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801960|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801961|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801962|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801963|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801964|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801965|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801966|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
803229|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
801967|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801968|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801969|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801970|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801971|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801972|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801973|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801974|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801975|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801976|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801977|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801978|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801979|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801980|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801981|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801982|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801983|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801984|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801985|NCT01391013|O2|Outcome|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801986|NCT01391013|O1|Outcome|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801987|NCT01391013|E2|Reported Event|Combination Therapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs)
801988|NCT01391013|E1|Reported Event|Monotherapy|2 tablets of darunavir (2 X 400 mg) and 1 tablet ritonavir (100 mg) administered once daily
801989|NCT01390909|B7|Baseline|Total|Total of all reporting groups
801990|NCT01390909|B6|Baseline|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
801991|NCT01390909|B5|Baseline|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (602 participants) were matched with participant records in the Medicaid, well-controlled cohort.
801992|NCT01390909|B4|Baseline|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
801993|NCT01390909|B3|Baseline|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
801994|NCT01390909|B2|Baseline|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup (3454 participants) were matched with participant records in the Medicaid, well-controlled cohort.
801995|NCT01390909|B1|Baseline|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
801996|NCT01390909|P6|Participant Flow|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
801997|NCT01390909|P5|Participant Flow|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
803866|NCT01382719|P3|Participant Flow|Bremelanotide Arm 2|middle dose 1.25 mg BMT
801998|NCT01390909|P4|Participant Flow|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
801999|NCT01390909|P3|Participant Flow|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
802000|NCT01390909|P2|Participant Flow|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy. Participants in the Medicaid, Uncontrolled, Subgroup were matched with participant records in the Medicaid, well-controlled cohort.
802001|NCT01390909|P1|Participant Flow|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
802002|NCT01390909|O8|Outcome|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
802003|NCT01390909|O7|Outcome|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
802004|NCT01390909|O6|Outcome|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
802005|NCT01390909|O5|Outcome|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
802006|NCT01390909|O4|Outcome|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
802007|NCT01390909|O3|Outcome|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
802008|NCT01390909|O2|Outcome|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
802009|NCT01390909|O1|Outcome|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
802010|NCT01390909|E8|Reported Event|Private, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
802011|NCT01390909|E7|Reported Event|Private, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy.
802012|NCT01390909|E6|Reported Event|Private, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visit
802013|NCT01390909|E5|Reported Event|Private, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visit within the next 365 days. This subgroup was matched with participant records in the private, well-controlled cohort.
802014|NCT01390909|E4|Reported Event|Medicaid, Intermediate|Database records for participants who are not classified as uncontrolled or well controlled
802015|NCT01390909|E3|Reported Event|Medicaid, Uncontrolled|Database records for participants with 2 or more consecutive changes in AED therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or ED visits within the next 365 days. This arm represents all participant records that met the criteria for uncontrolled epilepsy
802016|NCT01390909|E2|Reported Event|Medicaid, Well Controlled|Database records for participants with an epilepsy diagnosis but no AED change and no epilepsy-related inpatient or ED visits
802017|NCT01390909|E1|Reported Event|Medicaid, Uncontrolled, Subgroup|Database records for participants with 2 or more consecutive changes in anti-epileptic drug (AED) therapy occurring at least 30 days apart and followed by 1 or more epilepsy-related inpatient or emergency department (ED) visits within the next 365 days. This subgroup was matched with participant records in the Medicaid, well-controlled cohort
802018|NCT01390870|B1|Baseline|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
802019|NCT01390870|P1|Participant Flow|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
802020|NCT01390870|O1|Outcome|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
802021|NCT01390870|E1|Reported Event|All Enrolled Participants|Males at least 50 years of age who were residents of the United States with one or more diagnoses of enlarged prostate and one or more filled prescription medications within the past 12 months for enlarged prostate (EP) (alpha blocker [AB], 5-alpha reductase inhibitor [5-ARI], combination therapy)
802022|NCT01390857|B1|Baseline|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
802023|NCT01390857|P1|Participant Flow|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
803867|NCT01382719|P2|Participant Flow|Bremelanotide Arm 1|low dose 0.75 mg BMT
802024|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
802025|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
802026|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
802027|NCT01390857|O1|Outcome|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
802028|NCT01390857|E1|Reported Event|Valaciclovir|VALTREX Caplets: 1000 milligrams (mg) 3 times daily for pediatric participants whose weight is 40 kilograms (kg) or more. VALTREX Granules: 25 mg/kg 3 times daily.
802030|NCT01390844|B4|Baseline|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802031|NCT01390844|B3|Baseline|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802032|NCT01390844|B2|Baseline|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802033|NCT01390844|B1|Baseline|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802034|NCT01390844|P4|Participant Flow|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802035|NCT01390844|P3|Participant Flow|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802036|NCT01390844|P2|Participant Flow|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802037|NCT01390844|P1|Participant Flow|Boceprevir - Korea+Taiwan|PegIntron (pegylated interferon alfa-2b) (PEG) + ribavirin (RBV) for 4 weeks followed by boceprevir (BOC) + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable hepatitis C virus ribonucleic acid (HCV-RNA) at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802038|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802039|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802082|NCT01390818|P11|Participant Flow|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802040|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802041|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802042|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802043|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802044|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802045|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802046|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802047|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802048|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802049|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802050|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802051|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802052|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
803868|NCT01382719|P1|Participant Flow|Placebo|identical formulation without active ingredient
802053|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802054|NCT01390844|O2|Outcome|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802055|NCT01390844|O1|Outcome|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802056|NCT01390844|O2|Outcome|Control - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802057|NCT01390844|O1|Outcome|Boceprevir - Korea+Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802058|NCT01390844|E4|Reported Event|Control - India|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802059|NCT01390844|E3|Reported Event|Boceprevir - India|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802060|NCT01390844|E2|Reported Event|Control - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC placebo + PEG + RBV for 44 weeks. Participants with undetectable HCV-RNA at Treatment Week 12 and at all subsequent assays will continue on placebo + PEG + RBV through Treatment Week 48 and proceed to 24 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 12 may roll over to Cross-Over BOC treatment beginning with Treatment Week 14.
802061|NCT01390844|E1|Reported Event|Boceprevir - Korea + Taiwan|PEG + RBV for 4 weeks followed by BOC + PEG + RBV for 32 weeks. At the Treatment Week 36 visit, participants with undetectable HCV-RNA at Treatment Weeks 8 and 12 will proceed to 36 weeks of post-treatment follow-up. Participants with detectable HCV-RNA at Treatment Week 8 and undetectable HCV-RNA at Treatment Week 12 will continue on BOC + PEG + RBV until Treatment Week 36, receive placebo + PEG + RBV until Treatment Week 48, and then proceed to 24 weeks of post-treatment follow-up. Participants with any HCV-RNA result at Treatment Week 8 and detectable HCV-RNA at Treatment Week 12 will discontinue treatment and proceed to 24 weeks of post-treatment follow-up.
802062|NCT01390818|B16|Baseline|Total|Total of all reporting groups
802063|NCT01390818|B15|Baseline|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802064|NCT01390818|B14|Baseline|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802065|NCT01390818|B13|Baseline|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802083|NCT01390818|P10|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802572|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802066|NCT01390818|B12|Baseline|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802067|NCT01390818|B11|Baseline|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
803230|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
802068|NCT01390818|B10|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802069|NCT01390818|B9|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802070|NCT01390818|B8|Baseline|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802071|NCT01390818|B7|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802072|NCT01390818|B6|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802073|NCT01390818|B5|Baseline|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802074|NCT01390818|B4|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802075|NCT01390818|B3|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802076|NCT01390818|B2|Baseline|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802077|NCT01390818|B1|Baseline|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802078|NCT01390818|P15|Participant Flow|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802079|NCT01390818|P14|Participant Flow|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802080|NCT01390818|P13|Participant Flow|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802081|NCT01390818|P12|Participant Flow|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802368|NCT01390649|B1|Baseline|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
802084|NCT01390818|P9|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802085|NCT01390818|P8|Participant Flow|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802169|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802086|NCT01390818|P7|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802087|NCT01390818|P6|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802088|NCT01390818|P5|Participant Flow|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802089|NCT01390818|P4|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802090|NCT01390818|P3|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802091|NCT01390818|P2|Participant Flow|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802092|NCT01390818|P1|Participant Flow|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (Dose Escalation [DE] cohort).
802093|NCT01390818|O15|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802094|NCT01390818|O14|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802095|NCT01390818|O13|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802096|NCT01390818|O12|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802097|NCT01390818|O11|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802098|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802099|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802100|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802101|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802102|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802103|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802104|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802105|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802106|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802107|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802108|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802109|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802110|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject
802111|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802112|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802113|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802114|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802115|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802116|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802117|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject
802118|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802142|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802119|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802120|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802121|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802122|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802123|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802124|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802125|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802126|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802127|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802128|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802129|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802130|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802131|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802132|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802133|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802134|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802135|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802136|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802137|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802138|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802139|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802140|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802141|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802365|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
802366|NCT01390779|O1|Outcome|SENSIMED Triggerfish|
802367|NCT01390779|E1|Reported Event|SENSIMED Triggerfish|
802143|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802144|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
803231|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
802145|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802146|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802147|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802148|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802149|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802150|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802151|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802152|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802153|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802154|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802155|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802156|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802157|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802158|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802159|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802160|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802161|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802162|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802163|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802164|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802165|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802166|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802573|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
803869|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
802167|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802168|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802170|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802171|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802172|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802173|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802174|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802175|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802176|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802177|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802178|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802179|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802180|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802181|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802182|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802183|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802184|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802185|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802186|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802187|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802188|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802189|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802190|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802462|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802191|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802192|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802193|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802194|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802195|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802196|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802197|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802198|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802199|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802200|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802201|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802202|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802203|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802204|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802205|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802206|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802207|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802208|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802209|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802210|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802211|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802212|NCT01390818|O10|Outcome|MEL: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802213|NCT01390818|O9|Outcome|CRC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802214|NCT01390818|O8|Outcome|NSCLC: SAR245409 70mg Once|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802574|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802215|NCT01390818|O7|Outcome|TNBC: SAR245409 70mg Once Daily|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802216|NCT01390818|O6|Outcome|SAR245409 50mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802217|NCT01390818|O5|Outcome|SAR245409 30mg Twice Daily|SAR245409 capsule administered twice, orally, at a dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802218|NCT01390818|O4|Outcome|SAR245409 90mg|SAR245409 capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802219|NCT01390818|O3|Outcome|SAR245409 70mg|SAR245409 capsule administered at a single oral dose of 70 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802220|NCT01390818|O2|Outcome|SAR245409 50mg|SAR245409 capsule administered at a single oral dose of 50 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802221|NCT01390818|O1|Outcome|SAR245409 30mg|SAR245409 capsule administered at a single oral dose of 30 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802222|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802223|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802224|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802225|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802226|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802227|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802228|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802229|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802230|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802231|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802232|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802233|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802234|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802235|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802236|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802237|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802575|NCT01389882|E2|Reported Event|NS Group|NAVA first, then SIMV with PS
803870|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
802238|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802239|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802370|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
802240|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802241|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802242|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802243|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802244|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802245|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802246|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802247|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802248|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802249|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802250|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802251|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802252|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802253|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802254|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802255|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802256|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802257|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802258|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802259|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802260|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802261|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802262|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802263|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802264|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802265|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802266|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802267|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802268|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802269|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802270|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802271|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802272|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802273|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802274|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802275|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802276|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802277|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802278|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802279|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802280|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802281|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802282|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802283|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802284|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802285|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802286|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802287|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802288|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802289|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802290|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802291|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE Cohort).
802292|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802293|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802294|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802295|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802296|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802297|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802298|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802299|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802300|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802301|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802302|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802303|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802304|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802305|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802306|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802307|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802308|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802309|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802310|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802311|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802312|NCT01390818|O10|Outcome|MEL: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802313|NCT01390818|O9|Outcome|CRC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802314|NCT01390818|O8|Outcome|NSCLC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802315|NCT01390818|O7|Outcome|TNBC: Pimasertib 60mg Once Daily|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DSE Cohort).
802316|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 60mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 60 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802317|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 45mg Twice Daily|Pimasertib (MSC1936369B) capsule administered twice, orally, at a dose of 45 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802318|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 90mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 90 mg on Day 1 and 15 of cycle 1 until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802319|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 60mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 60 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802320|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 30 mg on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802321|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg|Pimasertib (MSC1936369B) capsule administered at a single oral dose of 15 milligram (mg) on Day 1 of 21 day cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802322|NCT01390818|O15|Outcome|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802323|NCT01390818|O14|Outcome|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802324|NCT01390818|O13|Outcome|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802325|NCT01390818|O12|Outcome|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Subjects with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject.
802326|NCT01390818|O11|Outcome|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
803871|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
802327|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802466|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802328|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802329|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802330|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802331|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802332|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802333|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802334|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802335|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802336|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of each 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802337|NCT01390818|O11|Outcome|Pimasertib (MSC1936369B) 45mg and SAR245409 50mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 45 mg along with twice oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802338|NCT01390818|O10|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 30mg Twice Daily|Pimasertib (MSC1936369B) capsule was administered twice orally at a dose of 60 mg along with twice oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802339|NCT01390818|O9|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 90mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 90 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802340|NCT01390818|O8|Outcome|Pimasertib (MSC1936369B) 90mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 90 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802341|NCT01390818|O7|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802342|NCT01390818|O6|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 70mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802343|NCT01390818|O5|Outcome|Pimasertib (MSC1936369B) 60mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 60 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802344|NCT01390818|O4|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
803019|NCT01387672|B1|Baseline|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
802345|NCT01390818|O3|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 50mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 mg along with single oral dose of 50 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802346|NCT01390818|O2|Outcome|Pimasertib (MSC1936369B) 30mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 30 mg along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802347|NCT01390818|O1|Outcome|Pimasertib (MSC1936369B) 15mg and SAR245409 30mg Once Daily|Pimasertib (MSC1936369B) capsule was administered at a single oral dose of 15 milligram (mg) along with single oral dose of 30 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the subject (DE cohort).
802348|NCT01390818|E15|Reported Event|MEL: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic melanoma (MEL) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
802349|NCT01390818|E14|Reported Event|CRC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic colorectal carcinoma/cancer (CRC) in DSE cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
802350|NCT01390818|E13|Reported Event|NSCLC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with a histologically confirmed diagnosis of relapsed or refractory metastatic non-small cell lung cancer (NSCLC) in disease specific expansion (DSE) cohort received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
802351|NCT01390818|E12|Reported Event|TNBC: Pimasertib 60mg and SAR245409 70mg Once Daily|Participants with relapsed or refractory metastatic triple negative breast cancer (TNBC) defined as estrogen, progesterone, and human epidermal growth factor receptor 2 (HER2) negative carcinoma of the breast with no approved therapies received Pimasertib (MSC1936369B) capsule at a single oral dose of 60 mg along with single oral dose of 70 mg SAR245409 capsule on Day 1 of 21 days cycle until disease progression, intolerable toxicity, Investigator’s decision to discontinue treatment, or withdrawal of consent by the participant (DSE Cohort).
802352|NCT01390818|E11|Reported Event|MSC1936369B (Pimasertib) 45mg and SAR245409 50mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 45 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
802353|NCT01390818|E10|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 30mg Twice Daily|MSC1936369B (Pimasertib) capsule administered twice at a dose of 60 mg on day 1 and 15 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 and 15 of each cycle (21 days) (DE cohort).
802354|NCT01390818|E9|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 90mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) (DE cohort).
802355|NCT01390818|E8|Reported Event|MSC1936369B (Pimasertib) 90mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 90 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
802356|NCT01390818|E7|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
802357|NCT01390818|E6|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 70mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 70 mg on day 1 of each cycle (21 days) (DE cohort).
802358|NCT01390818|E5|Reported Event|MSC1936369B (Pimasertib) 60mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 60 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
802359|NCT01390818|E4|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
802360|NCT01390818|E3|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 50mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 50 mg on day 1 of each cycle (21 days) (DE cohort).
802361|NCT01390818|E2|Reported Event|MSC1936369B (Pimasertib) 30mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
802362|NCT01390818|E1|Reported Event|MSC1936369B (Pimasertib) 15mg and SAR245409 30mg Once Daily|MSC1936369B (Pimasertib) capsule administered at a single dose of 15 milligram (mg) on day 1 of each cycle (21 days) along with SAR245409 capsule administered at a single dose of 30 mg on day 1 of each cycle (21 days) (DE cohort).
802363|NCT01390779|B1|Baseline|SENSIMED Triggerfish|
802364|NCT01390779|P1|Participant Flow|SENSIMED Triggerfish|"All subjects enrolled in the trial were housed in a sleep laboratory for 24 hours, during which they underwent SENSIMED Triggerfish recording on one randomly selected eye.~Parallel IOP measurements were taken using pneumatonometry on the eye contralateral to the SENSIMED Triggerfish eye before and after sleep onset. During sleep heart rate measurements were collected at specified time points."
802369|NCT01390649|P1|Participant Flow|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
802467|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802371|NCT01390649|O1|Outcome|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
802372|NCT01390649|E1|Reported Event|IgPro10|IgPro10 was administered by IV infusion either as a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first IgPro10 dose.
802373|NCT01390441|B6|Baseline|Total|Total of all reporting groups
802374|NCT01390441|B5|Baseline|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802375|NCT01390441|B4|Baseline|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802376|NCT01390441|B3|Baseline|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802377|NCT01390441|B2|Baseline|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802378|NCT01390441|B1|Baseline|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802379|NCT01390441|P5|Participant Flow|Part B: Rituxan® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802380|NCT01390441|P4|Participant Flow|Part B: MabThera® 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802381|NCT01390441|P3|Participant Flow|Part B: MK-8808 1000 mg / Extension B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802382|NCT01390441|P2|Participant Flow|Part A: MabThera® 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802383|NCT01390441|P1|Participant Flow|Part A: MK-8808 500 mg/m^2 / Extension A: MK-8808 1000 mg|Participants receive one course of MK-8808 (500 mg/m^2) administered intravenously (IV) on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) in the Treatment Period (up to Week 52) followed by open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) in the Extension Period (up to Week 106) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or intramuscularly (IM) for the duration of the trial.
802384|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802385|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802386|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802387|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802388|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
803020|NCT01387672|P6|Participant Flow|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Nitrates (NABT Main trial)"
802389|NCT01390441|O5|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
803232|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
802390|NCT01390441|O4|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802391|NCT01390441|O3|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802392|NCT01390441|O2|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802393|NCT01390441|O1|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802394|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802395|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously (SC), or IM for the duration of the trial.
802396|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802397|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802398|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802399|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802400|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, subcutaneously SC, or IM for the duration of the trial.
802401|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802402|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802403|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802404|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802405|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802406|NCT01390441|O10|Outcome|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802407|NCT01390441|O9|Outcome|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802408|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802409|NCT01390441|O7|Outcome|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
803021|NCT01387672|P5|Participant Flow|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
802410|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802411|NCT01390441|O5|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802412|NCT01390441|O4|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802413|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802414|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802415|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802416|NCT01390441|O10|Outcome|Extension B: Rituxan1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802417|NCT01390441|O9|Outcome|Extension B: MabThera 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802418|NCT01390441|O8|Outcome|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802419|NCT01390441|O7|Outcome|Extension A: MabThera 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802420|NCT01390441|O6|Outcome|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802421|NCT01390441|O5|Outcome|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802422|NCT01390441|O4|Outcome|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802423|NCT01390441|O3|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802424|NCT01390441|O2|Outcome|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802425|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802426|NCT01390441|O3|Outcome|Part B: Rituxan® 1000 mg|Participants receive one course of Rituxan® (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802427|NCT01390441|O2|Outcome|Part B: MabThera® 1000 mg|Participants receive one course of MabThera® (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802428|NCT01390441|O1|Outcome|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802429|NCT01390441|O2|Outcome|Part A: MabThera® 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802430|NCT01390441|O1|Outcome|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802463|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
803116|NCT01387230|E2|Reported Event|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
802431|NCT01390441|E10|Reported Event|Extension B: Rituxan® 1000 mg/MK-8808 1000 mg|Participants who completed Part B Rituxan® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802432|NCT01390441|E9|Reported Event|Extension B: MabThera® 1000 mg /MK-8808 1000 mg|Participants who completed Part B MabThera® will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802433|NCT01390441|E8|Reported Event|Extension B: MK-8808 1000 mg /MK-8808 1000 mg|Participants who completed Part B MK-8808 will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802434|NCT01390441|E7|Reported Event|Extension A: MabThera® 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MabThera® therapy will receive open label MK-8808 1000 mg IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802435|NCT01390441|E6|Reported Event|Extension A: MK-8808 500 mg/m^2 /MK-8808 1000 mg|Participants who completed Part A MK-8808 500 mg/m^2 therapy will receive open-label MK-8808 (1000 mg) IV at Week 54 and Week 56 (2nd optional course at Weeks 80 and 82) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802436|NCT01390441|E5|Reported Event|Part B: Rituxan 1000 mg|Participants receive one course of Rituxan (1000 mg) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802437|NCT01390441|E4|Reported Event|Part B: MabThera 1000 mg|Participants receive one course of MabThera (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802438|NCT01390441|E3|Reported Event|Part B: MK-8808 1000 mg|Participants receive one course of MK-8808 (1000 mg) IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802439|NCT01390441|E2|Reported Event|Part A: MabThera 500 mg/m^2|Participants receive one course of MabThera® (500 mg/m^2) administered IV on Day 1 and Day 15 (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802440|NCT01390441|E1|Reported Event|Part A: MK-8808 500 mg/m^2|Participants receive one course of MK-8808 (500 mg/m^2) administered IV on Day 1 and Day 15; (2nd optional course of treatment at Weeks 26 and 28) + methotrexate 12.5 to 25 mg/week (or 10 mg if greater dose not tolerated) either orally, SC, or IM for the duration of the trial.
802441|NCT01390428|B7|Baseline|Total|Total of all reporting groups
802442|NCT01390428|B6|Baseline|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802443|NCT01390428|B5|Baseline|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802444|NCT01390428|B4|Baseline|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802445|NCT01390428|B3|Baseline|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802446|NCT01390428|B2|Baseline|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802447|NCT01390428|B1|Baseline|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802448|NCT01390428|P6|Participant Flow|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802449|NCT01390428|P5|Participant Flow|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802450|NCT01390428|P4|Participant Flow|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802451|NCT01390428|P3|Participant Flow|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802452|NCT01390428|P2|Participant Flow|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802453|NCT01390428|P1|Participant Flow|Part 1-Mild Hepatic Impairment (HI)|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802454|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802455|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802456|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802457|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802458|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802459|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802460|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802461|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802464|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802465|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802468|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802469|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802470|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802471|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802472|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802473|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802474|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802475|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802476|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802477|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802478|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802479|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802480|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802481|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802482|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802483|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802484|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802485|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802486|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802487|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802488|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802489|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802490|NCT01390428|O6|Outcome|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802491|NCT01390428|O5|Outcome|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802492|NCT01390428|O4|Outcome|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802493|NCT01390428|O3|Outcome|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802494|NCT01390428|O2|Outcome|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802495|NCT01390428|O1|Outcome|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802496|NCT01390428|E6|Reported Event|Part 3-Healthy Matched to Severe HI|Healthy participants received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802497|NCT01390428|E5|Reported Event|Part 3-Severe HI|Participants with severe HI received 50 mg of Grazoprevir once a day for 10 consecutive days during Part 3 of the study.
802498|NCT01390428|E4|Reported Event|Part 2-Healthy Matched to Moderate HI|Healthy participants received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802499|NCT01390428|E3|Reported Event|Part 2-Moderate HI|Participants with moderate HI received 100 mg of Grazoprevir once a day for 10 consecutive days during Part 2 of the study.
802500|NCT01390428|E2|Reported Event|Part 1-Healthy Matched to Mild HI|Healthy participants received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802501|NCT01390428|E1|Reported Event|Part 1-Mild HI|Participants with mild HI received 200 mg of Grazoprevir once a day for 10 consecutive days during Part 1 of the study.
802502|NCT01390415|B3|Baseline|Total|Total of all reporting groups
802503|NCT01390415|B2|Baseline|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802504|NCT01390415|B1|Baseline|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802505|NCT01390415|P2|Participant Flow|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802506|NCT01390415|P1|Participant Flow|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802507|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802508|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802509|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802510|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802511|NCT01390415|O2|Outcome|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802512|NCT01390415|O1|Outcome|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802513|NCT01390415|E2|Reported Event|Losartan 100 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 100 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802514|NCT01390415|E1|Reported Event|Losartan 50 mg|Adults with Type II diabetes mellitus with hypertension and microalbuminuria who received losartan 50 mg for at least 6 months during the period between 1 June 2007 and 31 December 2008.
802515|NCT01390402|B1|Baseline|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
802516|NCT01390402|P1|Participant Flow|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
802517|NCT01390402|O1|Outcome|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
802518|NCT01390402|E1|Reported Event|NK Infusion + Chemotherapy|Fludarabine 40 mg/m^2 intravenous (IV) daily for four (4) consecutive days, Days -13 to -10, immediately followed by Busulfan 130 mg/ m^2 IV for 2 doses on Days -11 to -10 and Natural killer (NK) cell infusion Iv administered on Day -8. Interleukin-2: 0.5 million units subcutaneously daily for 5 days on Day -8 to day -4; Anti-Thymocyte Globulin: 2.5 mg/kg IV for 3 doses on Days -3 to -1. Allogeneic related stem cell transplant IV Day 0. Tacrolimus: Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Methotrexate 5 mg/m2 by vein Days 1, 3 and 6 post transplant. G-CSF 5 mcg/kg/day subcutaneously beginning on Day + 7.
802519|NCT01390389|B3|Baseline|Total|Total of all reporting groups
802520|NCT01390389|B2|Baseline|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
802521|NCT01390389|B1|Baseline|Control|Healthy controls with no evidence of current or past psychiatric disorders.
802522|NCT01390389|P2|Participant Flow|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
802523|NCT01390389|P1|Participant Flow|Control|Healthy controls with no evidence of current or past psychiatric disorders.
802524|NCT01390389|O2|Outcome|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
802525|NCT01390389|O1|Outcome|Control|Healthy controls with no evidence of current or past psychiatric disorders.
802526|NCT01390389|E2|Reported Event|CoQ10|Subjects with Bipolar disorder who received CoQ10 therapy for 4 weeks. Subjects in this group started at 400 mg of CoQ10 a day, and increased to 800 mg a day at 2 weeks.
802527|NCT01390389|E1|Reported Event|Control|Healthy controls with no evidence of current or past psychiatric disorders.
802528|NCT01390038|B1|Baseline|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802529|NCT01390038|P1|Participant Flow|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802530|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802531|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802532|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802533|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802534|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802535|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802536|NCT01390038|O1|Outcome|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802537|NCT01390038|E1|Reported Event|Simpliciti™ Shoulder System|"The Simpliciti™ Shoulder System is intended for Total Shoulder Arthroplasty of the shoulder.~Simpliciti™ Shoulder System: Total shoulder arthroplasty system"
802538|NCT01389973|B1|Baseline|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802539|NCT01389973|P1|Participant Flow|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802540|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802541|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802542|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802543|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802544|NCT01389973|O1|Outcome|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802545|NCT01389973|E1|Reported Event|Open-label: Ustekinumab 90 mg|In proof of concept phase of Part 1, participants received ustekinumab 90 milligram (mg) subcutaneously at Week 0, 4 and thereafter every 8 weeks through Week 20. Eligible participants entered long-term extension which began at Week 28 and continued through Week 216.
802546|NCT01389882|B3|Baseline|Total|Total of all reporting groups
802547|NCT01389882|B2|Baseline|NS Group|NAVA first, then SIMV with PS
802548|NCT01389882|B1|Baseline|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
802549|NCT01389882|P2|Participant Flow|NS Group|NAVA first, then SIMV with PS
802550|NCT01389882|P1|Participant Flow|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
802551|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802552|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802553|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802554|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802555|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802556|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802557|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802558|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802559|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802560|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802561|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802562|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802563|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802564|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802565|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802566|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802567|NCT01389882|O2|Outcome|NAVA|neurally adjusted ventilatory assist
802568|NCT01389882|O1|Outcome|SIMV With PS|synchronized intermittent mandatory ventilation with pressure support
802576|NCT01389882|E1|Reported Event|SN Group|Synchronized intermittent mandatory ventilation (SIMV) with Pressure support (PS) first, then Neurally adjusted ventilatory assist (NAVA)
802577|NCT01389856|B3|Baseline|Total|Total of all reporting groups
802578|NCT01389856|B2|Baseline|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802579|NCT01389856|B1|Baseline|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802580|NCT01389856|P2|Participant Flow|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802581|NCT01389856|P1|Participant Flow|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802582|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802583|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802584|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802585|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802586|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802587|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802588|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802589|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802590|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802591|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802592|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802593|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802594|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802595|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802596|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802597|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802598|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802599|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802600|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802601|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802602|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802603|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802604|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802605|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802606|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802607|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802608|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802609|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802610|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
803233|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
802611|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802612|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802613|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802614|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802615|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802616|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802617|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802618|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802619|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802620|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802621|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802622|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802623|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802624|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802625|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802626|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802627|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802628|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802629|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802630|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802631|NCT01389856|O2|Outcome|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802632|NCT01389856|O1|Outcome|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802633|NCT01389856|E2|Reported Event|Placebo|"Matching placebo~Matching placebo: twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube."
802634|NCT01389856|E1|Reported Event|Bosentan|"Bosentan~Bosentan: 2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube."
802635|NCT01389817|B3|Baseline|Total|Total of all reporting groups
802636|NCT01389817|B2|Baseline|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
802637|NCT01389817|B1|Baseline|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
802638|NCT01389817|P2|Participant Flow|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
802747|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802639|NCT01389817|P1|Participant Flow|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
802640|NCT01389817|O2|Outcome|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
802641|NCT01389817|O1|Outcome|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
802642|NCT01389817|E2|Reported Event|Asymptomatic LHON Mutation Carriers|Study Arm 2) asymptomatic LHON mutation carriers. Can be male or female; have some dysfunction, with changes occurring over months. Patients in study arm 2 will not be exposed to NIR-LED, but only undergo diagnostic studies.
802643|NCT01389817|E1|Reported Event|Symptomatic LHON Patients.|"Study Arm 1) symptomatic LHON patients. Male and female LHON patients with treatable bilateral optic atrophy. Treat the worse of the 2 eyes if there is a measurable difference in subjective visual functions (visual acuity, peripheral vision).~Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.)): Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily."
802644|NCT01389596|B4|Baseline|Total|Total of all reporting groups
802645|NCT01389596|B3|Baseline|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802646|NCT01389596|B2|Baseline|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802647|NCT01389596|B1|Baseline|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802648|NCT01389596|P3|Participant Flow|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802649|NCT01389596|P2|Participant Flow|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802650|NCT01389596|P1|Participant Flow|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and less than (<) 30 kilograms (kg) in weight, received pregabalin 3.5 milligram per kilogram per day (mg/kg/day) (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and greater than or equal to (>=) 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802651|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802652|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802742|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802775|NCT01389102|P3|Participant Flow|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802653|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802654|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802655|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802656|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802657|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802658|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802659|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802660|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802661|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802662|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802663|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802664|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802665|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802666|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802667|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802668|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802669|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802670|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802671|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802672|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802673|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802674|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802675|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802676|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802677|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802678|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802679|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802680|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802681|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802682|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802683|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802684|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802685|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802686|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802687|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802688|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802689|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802690|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802691|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802692|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802693|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802694|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802695|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802696|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802697|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802698|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802699|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802700|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802701|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802702|NCT01389596|O3|Outcome|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802703|NCT01389596|O2|Outcome|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802704|NCT01389596|O1|Outcome|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802705|NCT01389596|E3|Reported Event|Placebo|Participants aged 4 to 16 years received placebo matched to pregabalin, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants <30 kg in weight received placebo in the form of oral solution while participants >=30 kg in weight received placebo in the form of oral solution or capsule.
802706|NCT01389596|E2|Reported Event|Pregabalin: 10 mg/kg/Day or 14 mg/kg/Day|Participants aged 4 to 16 years and < 30 kg in weight, received pregabalin 14 mg/kg/day (up to a maximum of 600 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 10 mg/kg/day (up to a maximum of 600 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802707|NCT01389596|E1|Reported Event|Pregabalin: 2.5 mg/kg/Day or 3.5 mg/kg/Day|Participants aged 4 to 16 years and <30 kg in weight, received pregabalin 3.5 mg/kg/day (up to a maximum of 150 mg/day) oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months). Participants aged 4 to 16 years and >= 30 kg in weight, received pregabalin 2.5 mg/kg/day (up to a maximum of 150 mg/day) capsule or oral solution, orally twice daily in equally divided doses, for the double-blind treatment phase of 12 weeks (3 months).
802708|NCT01389323|B1|Baseline|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
802709|NCT01389323|P1|Participant Flow|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
802743|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802773|NCT01389102|P5|Participant Flow|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802710|NCT01389323|O5|Outcome|Overall Population|Participants received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
802711|NCT01389323|O4|Outcome|Non-Latino Cohort|Participants belonging to Non-Latino ethnicity, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
802712|NCT01389323|O3|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
802713|NCT01389323|O2|Outcome|White/Caucasian Cohort|Participants belonging to White/Caucasian race, received daclatasvir (BMS-790052) tablets 60 mg orally, once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 800 mg orally, twice daily, for 24 weeks (for participants who had achieved the virologic response at Weeks 4 and 12) to 48 weeks (for participants who did not achieve the virologic response at Weeks 4 and 12). For participants weighing <75 kg, the total dose of ribavirin was 1000 mg per day and for those weighing ≥75 kg, the dose was 1200 mg per day. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
802714|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included Latino and Non-Latino participants.
802715|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
802716|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
802717|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
802744|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
803872|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
802718|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
802719|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
802720|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
802721|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
802722|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
802723|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
802724|NCT01389323|O3|Outcome|White Non-Latino Cohort|Participants belonging to White race and Non-Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs.
802745|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802746|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802854|NCT01388907|B1|Baseline|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
802725|NCT01389323|O2|Outcome|Latino Cohort|Participants belonging to Latino ethnicity, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and AEs. This cohort included White/Caucasian and Black/African American participants.
802726|NCT01389323|O1|Outcome|Black/African American Cohort|Participants belonging to Black/African American race, received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (HCV RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events (AEs). This cohort included Latino and Non-Latino participants.
802727|NCT01389323|E1|Reported Event|Daclatasvir + Pegylated-interferon Alfa 2a + Ribavirin|Participants received daclatasvir (BMS-790052) 60 mg tablet orally once daily, along with pegylated-interferon alfa 2a solution for injection 180 μg/0.5 mL subcutaneously once weekly, and ribavirin 1000 mg per day for those weighing <75 kg or 1200 mg per day for those weighing ≥75 kg for a period of 24 weeks. Participants who achieved a virologic response (Hepatitis C Virus RNA undetectable at both Weeks 4 and 12) completed therapy at Week 24 and were followed for 48 weeks of post-treatment follow-up. Participants who did not achieve the virologic response, continued to receive pegylated-interferon alfa 2a and ribavirin for additional 24 weeks (total treatment duration of 48 weeks), and were followed for 24 weeks of post-treatment follow-up. Dose modifications to pegylated-interferon alfa 2a and ribavirin were allowed to manage tolerability and adverse events.
802728|NCT01389284|B4|Baseline|Total|Total of all reporting groups
802729|NCT01389284|B3|Baseline|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802730|NCT01389284|B2|Baseline|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802731|NCT01389284|B1|Baseline|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802732|NCT01389284|P3|Participant Flow|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802733|NCT01389284|P2|Participant Flow|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802734|NCT01389284|P1|Participant Flow|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802735|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802736|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802737|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802738|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802739|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802740|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802741|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802772|NCT01389102|P6|Participant Flow|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802748|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802749|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802750|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802751|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802752|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802753|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802754|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802755|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802756|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802757|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802758|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802759|NCT01389284|O3|Outcome|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802760|NCT01389284|O2|Outcome|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802761|NCT01389284|O1|Outcome|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802762|NCT01389284|E3|Reported Event|Placebo|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg matching placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802763|NCT01389284|E2|Reported Event|Naproxen Sodium IR (Aleve, BAYH6689)|1 naproxen sodium ER 660 mg matching placebo tablet and 1 naproxen sodium IR 220 mg tablet initially followed by 1 naproxen sodium IR 220 mg tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg tablet eight hours at hour 16 (± 15 min)
802764|NCT01389284|E1|Reported Event|Naproxen Sodium ER (BAYH6689)|1 naproxen sodium extended release (ER) 660 mg tablet and 1 naproxen sodium immediate release (IR) 220 mg placebo tablet initially followed by 1 naproxen sodium IR 220 mg matching placebo tablet at hour 8 (± 15 min), and 1 naproxen sodium IR 220 mg matching placebo tablet at hour 16 (± 15 min)
802765|NCT01389102|B7|Baseline|Total|Total of all reporting groups
802766|NCT01389102|B6|Baseline|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802767|NCT01389102|B5|Baseline|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802768|NCT01389102|B4|Baseline|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802769|NCT01389102|B3|Baseline|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802770|NCT01389102|B2|Baseline|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802771|NCT01389102|B1|Baseline|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
803873|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
802774|NCT01389102|P4|Participant Flow|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802776|NCT01389102|P2|Participant Flow|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802777|NCT01389102|P1|Participant Flow|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802778|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802779|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802780|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802781|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802782|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802783|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802784|NCT01389102|O6|Outcome|Estradiol Transdermal One 90 μL Spray|
802785|NCT01389102|O5|Outcome|Estradiol Transdermal Two 90 μL Sprays|
802786|NCT01389102|O4|Outcome|Estradiol Transdermal Three 90 μL Sprays|
802787|NCT01389102|O3|Outcome|Placebo Transdermal One 90 μL Spray|
802788|NCT01389102|O2|Outcome|Placebo Transdermal Two 90 μL Sprays|
802789|NCT01389102|O1|Outcome|Placebo Transdermal Three 90 μL Sprays|
802790|NCT01389102|E6|Reported Event|Estradiol Transdermal One 90 μL Spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802791|NCT01389102|E5|Reported Event|Estradiol Transdermal Two 90 μL Sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802792|NCT01389102|E4|Reported Event|Estradiol Transdermal Three 90 μL Sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802793|NCT01389102|E3|Reported Event|Placebo Transdermal One 90 μL Spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
802794|NCT01389102|E2|Reported Event|Placebo Transdermal Two 90 μL Sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802795|NCT01389102|E1|Reported Event|Placebo Transdermal Three 90 μL Sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
802796|NCT01389076|B1|Baseline|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802797|NCT01389076|P1|Participant Flow|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802798|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802799|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802800|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802801|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802855|NCT01388907|P2|Participant Flow|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
803022|NCT01387672|P4|Participant Flow|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
802856|NCT01388907|P1|Participant Flow|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
803234|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
802802|NCT01389076|O1|Outcome|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802803|NCT01389076|E1|Reported Event|Methotrexate and Bexxar|"Low dose methotrexate and Bexxar (tositumomab)~Patients will begin taking methotrexate 7.5 mg orally once weekly 3 weeks prior to initiating I-131 tositumomab, with additional weekly doses once I-131 tositumomab therapy has begun for a total of 10 doses.~On Study Day 0, patients will receive the IV administration of 450 mg unlabeled tositumomab followed by the IV administration of the dosimetric dose (5 mCi of Iodine I 131 tositumomab)."
802804|NCT01388946|B3|Baseline|Total|Total of all reporting groups
802805|NCT01388946|B2|Baseline|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802806|NCT01388946|B1|Baseline|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802807|NCT01388946|P2|Participant Flow|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802808|NCT01388946|P1|Participant Flow|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802809|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802810|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802811|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802812|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802813|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802814|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802815|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802816|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802817|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802818|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802819|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802820|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802821|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802822|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802823|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802824|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802825|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802826|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802827|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802828|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802829|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802830|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802831|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802832|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802833|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802834|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802835|NCT01388946|O2|Outcome|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802836|NCT01388946|O1|Outcome|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802837|NCT01388946|E2|Reported Event|Normal Saline|"Continuous infusion of normal saline 2 ml/h for 24 hours~Normal saline"
802838|NCT01388946|E1|Reported Event|Ropivacaine 0.75|"Continuous infusion of ropivacaine 7.5 mg/ml, 2 ml/h for 24 hours~Ropivacaine 0.75"
802839|NCT01388920|B4|Baseline|Total|Total of all reporting groups
802840|NCT01388920|B3|Baseline|Placebo|Placebo for 6 months
802841|NCT01388920|B2|Baseline|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
802842|NCT01388920|B1|Baseline|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
802843|NCT01388920|P3|Participant Flow|Placebo|Placebo for 6 monts
802844|NCT01388920|P2|Participant Flow|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
802845|NCT01388920|P1|Participant Flow|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
802846|NCT01388920|O3|Outcome|Placebo|Placebo for 6 months
802847|NCT01388920|O2|Outcome|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
802848|NCT01388920|O1|Outcome|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
802849|NCT01388920|E3|Reported Event|Placebo|Placebo for 6 months
802850|NCT01388920|E2|Reported Event|Tesamorelin 3 mg|Tesamorelin 3 mg/day for 6 months
802851|NCT01388920|E1|Reported Event|Tesamorelin 2 mg|Tesamorelin 2 mg/day for 6 months
802852|NCT01388907|B3|Baseline|Total|Total of all reporting groups
802853|NCT01388907|B2|Baseline|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
803023|NCT01387672|P3|Participant Flow|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
802857|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
802858|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
802859|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
802860|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formati.
802861|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
802862|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Patients randomized in the Prevadh group have been treated with Prevadh film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
802863|NCT01388907|O2|Outcome|Ringer Lactate™ (R) Group|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
802864|NCT01388907|O1|Outcome|Prevadh™ (P) Group|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
802865|NCT01388907|E2|Reported Event|Ringer Lactate™ (R) Group With Adverse Event|Patients randomized in the Ringer solution group have been treated with Ringer lactate solution directly applied to the uterine surgical sites at the end of the myomectomy surgery.
802866|NCT01388907|E1|Reported Event|Prevadh™ (P) Group With Adverse Event|Patients randomized in the Prevadh group have been treated with Prevadh Film directly applied to the uterine surgical sites at the end of the myomectomy surgery.
802867|NCT01388816|B5|Baseline|Total|Total of all reporting groups
802868|NCT01388816|B4|Baseline|DRL-17822 300 mg|Once daily after breakfast
802869|NCT01388816|B3|Baseline|DRL-17822 150 mg|Once daily after breakfast
802870|NCT01388816|B2|Baseline|DRL-17822 50 mg|Once daily after breakfast
802871|NCT01388816|B1|Baseline|Placebo Capsule|Once daily after breakfast
802872|NCT01388816|P4|Participant Flow|DRL-17822 300 mg|Once daily after breakfast
802873|NCT01388816|P3|Participant Flow|DRL-17822 150 mg|Once daily after breakfast
802874|NCT01388816|P2|Participant Flow|DRL-17822 50 mg|Once daily after breakfast
802875|NCT01388816|P1|Participant Flow|Placebo|Once daily after breakfast
802876|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
802877|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
802878|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
802879|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
802880|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
802881|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
802882|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
802883|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
802884|NCT01388816|O3|Outcome|DRL-17822 300 mg|Once daily after breakfast
802885|NCT01388816|O2|Outcome|DRL-17822 150 mg|Once daily after breakfast
802886|NCT01388816|O1|Outcome|DRL-17822 50 mg|Once daily after breakfast
802887|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
802888|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
802889|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
802890|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
802891|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
802892|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
802893|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
802894|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
802895|NCT01388816|O4|Outcome|DRL-17822 300 mg|Once daily after breakfast
802896|NCT01388816|O3|Outcome|DRL-17822 150 mg|Once daily after breakfast
802897|NCT01388816|O2|Outcome|DRL-17822 50 mg|Once daily after breakfast
802898|NCT01388816|O1|Outcome|Placebo Capsule|Once daily after breakfast
802899|NCT01388816|E4|Reported Event|DRL-17822 300 mg|Once daily after breakfast
802900|NCT01388816|E3|Reported Event|DRL-17822 150 mg|Once daily after breakfast
802901|NCT01388816|E2|Reported Event|DRL-17822 50 mg|Once daily after breakfast
802902|NCT01388816|E1|Reported Event|Placebo Capsule|Once daily after breakfast
802903|NCT01388790|B1|Baseline|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
802904|NCT01388790|P1|Participant Flow|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
802936|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802937|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802938|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802905|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
802906|NCT01388790|O1|Outcome|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
802907|NCT01388790|E1|Reported Event|Cetuximab Plus Cisplatin Plus S-1|Cetuximab once weekly (initial dose 400 milligram per square meter [mg/m^2] followed by subsequent 250 mg/m^2 intravenous infusion), cisplatin (60 mg/m^2 intravenous infusion on Day 8 of 5-week cycle maximum up to 8 cycles) and S-1, a combination of tegafur, gimeracil, and oteracil (40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle) was administered until disease progression, unacceptable toxicity, or withdrawal of consent.
802908|NCT01388647|B3|Baseline|Total|Total of all reporting groups
802909|NCT01388647|B2|Baseline|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
802910|NCT01388647|B1|Baseline|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
802911|NCT01388647|P2|Participant Flow|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
802912|NCT01388647|P1|Participant Flow|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
802913|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
802914|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
802915|NCT01388647|O1|Outcome|All Study Participants|All subjects were assigned to receive either a starting dose of eribulin 1.1 mg/m^2 or eribulin 1.4 mg/m^2.
802916|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
802917|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
802918|NCT01388647|O2|Outcome|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
802919|NCT01388647|O1|Outcome|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
802920|NCT01388647|E2|Reported Event|Eribulin 1.4 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.4 mg/m2
802921|NCT01388647|E1|Reported Event|Eribulin 1.1 mg/m2|Subjects assigned to receive a starting dose of eribulin 1.1 mg/m2
802922|NCT01388530|B1|Baseline|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
802923|NCT01388530|P1|Participant Flow|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
802924|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
802925|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
802926|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
802927|NCT01388530|O1|Outcome|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
802928|NCT01388530|E1|Reported Event|Trigeminal Nerve Stimulation|"Open label treatment with trigeminal nerve stimulation in an 8-week trial.~EMS 7500 Digital Muscle Stimulator : A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep."
802929|NCT01388491|B3|Baseline|Total|Total of all reporting groups
802930|NCT01388491|B2|Baseline|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802931|NCT01388491|B1|Baseline|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802932|NCT01388491|P2|Participant Flow|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802933|NCT01388491|P1|Participant Flow|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802934|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802935|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
803874|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
802939|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802940|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802941|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802942|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802943|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802944|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802945|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802946|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802947|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802948|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802949|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802950|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802951|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802952|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802953|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802954|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802955|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802956|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802957|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802958|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802959|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802960|NCT01388491|O2|Outcome|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802961|NCT01388491|O1|Outcome|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802962|NCT01388491|E2|Reported Event|Treatment II|21 days combination active pills (containing 150 mcg DSG/20 mcg EE), taken orally and followed by 7 days of no treatment for a total of 6 consecutive 28-day cycles
802963|NCT01388491|E1|Reported Event|Treatment I: (DR-102)|21 days of combination active pills (containing 150 mcg desogestrel [DSG]/20 mcg ethinyl estradiol [EE]), followed by 7 days of 10 mcg EE, taken orally for 6 consecutive 28-day cycles
802964|NCT01388361|B4|Baseline|Total|Total of all reporting groups
802965|NCT01388361|B3|Baseline|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802966|NCT01388361|B2|Baseline|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
803015|NCT01387672|B5|Baseline|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
803016|NCT01387672|B4|Baseline|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
803017|NCT01387672|B3|Baseline|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
803024|NCT01387672|P2|Participant Flow|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
803025|NCT01387672|P1|Participant Flow|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
802967|NCT01388361|B1|Baseline|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
802968|NCT01388361|P3|Participant Flow|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802969|NCT01388361|P2|Participant Flow|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802970|NCT01388361|P1|Participant Flow|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
802971|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802972|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802973|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
802974|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802975|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802976|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
802977|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802978|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802979|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
802980|NCT01388361|O3|Outcome|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802981|NCT01388361|O2|Outcome|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
803018|NCT01387672|B2|Baseline|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
803875|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
802982|NCT01388361|O1|Outcome|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
802983|NCT01388361|E3|Reported Event|IDeg + IAsp OD|Subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in prefilled pen along with once-daily subcutaneous administration of insulin aspart (IAsp)100 U/mL in a FlexPen® administered just before the largest meal for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802984|NCT01388361|E2|Reported Event|IDeg + Liraglutide|All subjects in this arm were randomised to once-daily subcutaneous administration of IDeg 100 U/mL in a prefilled pen along with once-daily subcutaneous administration of liraglutide (6 mg/mL) in a prefilled pen for 26 weeks of treatment. Subjects continued their oral antidiabetic drug metformin at a stable, pre-trial dose throughout the trial period.
802985|NCT01388361|E1|Reported Event|IDeg|This non-randomised arm consisted of subjects treated with IDeg + metformin who achieved the target glycosylated haemoglobin (HbA1c) < 7.0 % at the end of treatment in NN1250-3643. Subjects were treated with once-daily subcutaneous administration of IDeg 100 U/mL prefilled pen along with stable and pre-trial dose of oral antidiabetic drug metformin for 26-weeks. These subjects continued on IDeg + metformin to assess the treatment regimen’s ability to sustain long term glycaemic control. No comparisons of endpoints were made between the non-randomised and randomised treatment arms.
802986|NCT01388166|B1|Baseline|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
802987|NCT01388166|P1|Participant Flow|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
802988|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
802989|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
802990|NCT01388166|O1|Outcome|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) for at least 1 month and within product label.
802991|NCT01388166|E1|Reported Event|Patients With COPD|Patients with a clinical diagnosis of chronic obstructive pulmonary disease (COPD) being treated with the maintenance therapy with long-acting anticholinergic (Tiotropium) at least 1 months and within product label.
802992|NCT01387789|B1|Baseline|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
802993|NCT01387789|P1|Participant Flow|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
802994|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
802995|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
802996|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
802997|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
802998|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
802999|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
803000|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
803001|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
803002|NCT01387789|O1|Outcome|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
803003|NCT01387789|E1|Reported Event|Scheduled to Start Adalimumab Therapy|Patients diagnosed with rheumatoid arthritis for at least 3 months that previously had not received prior anti-TNF agents.
803004|NCT01387737|B3|Baseline|Total|Total of all reporting groups
803005|NCT01387737|B2|Baseline|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
803006|NCT01387737|B1|Baseline|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
803007|NCT01387737|P2|Participant Flow|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
803008|NCT01387737|P1|Participant Flow|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
803009|NCT01387737|O2|Outcome|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
803010|NCT01387737|O1|Outcome|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
803011|NCT01387737|E2|Reported Event|TA-7284-High|TA-7284 high dose, once daily for 52 weeks
803012|NCT01387737|E1|Reported Event|TA-7284-Low|TA-7284 low dose, once daily for 52 weeks
803013|NCT01387672|B7|Baseline|Total|Total of all reporting groups
803014|NCT01387672|B6|Baseline|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
803876|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
803026|NCT01387672|O1|Outcome|Run-in Phase|During the run-in phase subjects received, in random order, each of the 5 nitrate formulations for 2 days with a 2 day wash out period between formulations. The severity of headaches was recorded, by subjects, upon awakening, every day during the run in phase using a visual analog scale (VAS).
803027|NCT01387672|O6|Outcome|Placebo Ointment - Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
803028|NCT01387672|O5|Outcome|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
803029|NCT01387672|O4|Outcome|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
803030|NCT01387672|O3|Outcome|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
803031|NCT01387672|O2|Outcome|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
803032|NCT01387672|O1|Outcome|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
803033|NCT01387672|E6|Reported Event|Placebo Ointment- Treatment Arm 6|"Placebo Ointment~Placebo: Placebo ointment Nitrates (NABT Main trial)"
803034|NCT01387672|E5|Reported Event|0.6 Sublingual (Nitrostat 2) - Treatment Arm 5|"Nitroglycerin 0.6mg Sublingual Tablet~Nitrates (NABT Main trial)"
803035|NCT01387672|E4|Reported Event|0.3 Sublingual (Nitrostat 1) - Treatment Arm 4|"Nitroglycerin 0.3mg Sublingual Tablet~Nitrates (NABT Main trial)"
803036|NCT01387672|E3|Reported Event|Ointment (Nitrol) - Treatment Arm 3|"Nitroglycerin Ointment 2% USP~Nitrates (NABT Main trial)"
803037|NCT01387672|E2|Reported Event|Patch (Nitro-Dur) - Treatment Arm 2|"Nitroglycerin Extended Release Patch 160mg~Nitrates (NABT Main trial)"
803038|NCT01387672|E1|Reported Event|ISMO - Treatment Arm 1|"Isosorbide Mononitrate 20mg Oral Tablet~Nitrates (NABT Main trial)"
803039|NCT01387594|B3|Baseline|Total|Total of all reporting groups
803040|NCT01387594|B2|Baseline|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803041|NCT01387594|B1|Baseline|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803042|NCT01387594|P2|Participant Flow|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803043|NCT01387594|P1|Participant Flow|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803044|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803045|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803046|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803047|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had Crohns disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803073|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
803074|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
803877|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
803075|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
803048|NCT01387594|O2|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803049|NCT01387594|O1|Outcome|Cohort 1: PF-00547659|Participants who had CD and who satisfied all study entry criteria were enrolled into the study. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). 2 LPs were to be performed during participation. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803050|NCT01387594|O1|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803051|NCT01387594|O1|Outcome|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803052|NCT01387594|E2|Reported Event|Cohort 2: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Participants underwent 2 lumbar punctures (LP), 1 prior to treatment and another 1-3 weeks after the last dose. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) on Days 1, 29, and 57. At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803053|NCT01387594|E1|Reported Event|Cohort 1: PF-00547659|Participants who had Crohn's disease (CD) and who satisfied all study entry criteria were enrolled into the study. Prior to treatment, participants underwent 2 lumbar punctures (LP) 2-4 weeks apart. All participants received 3 monthly subcutaneous (SC) doses of PF-00547659 225 milligrams (mg) (Days 1, 29, 57). At Week 12, participants who had a clinical response to treatment could enter the open-label extension study. Otherwise, participants would enter a 6-month follow-up period onsite.
803054|NCT01387581|B4|Baseline|Total|Total of all reporting groups
803055|NCT01387581|B3|Baseline|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803056|NCT01387581|B2|Baseline|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
803057|NCT01387581|B1|Baseline|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803058|NCT01387581|P3|Participant Flow|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803059|NCT01387581|P2|Participant Flow|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
803060|NCT01387581|P1|Participant Flow|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803061|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803062|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
803063|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803064|NCT01387581|O3|Outcome|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803065|NCT01387581|O2|Outcome|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
803066|NCT01387581|O1|Outcome|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803067|NCT01387581|E3|Reported Event|Experts Without MelaFind|PSL Experts, prospectively identified and recruited by the PI after the general recruitment is completed. They will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803068|NCT01387581|E2|Reported Event|With MelaFind|Study dermatologists will review clinical exam information, 3 high quality digital images, and MelaFind result for each lesion
803069|NCT01387581|E1|Reported Event|Without MelaFind|Study dermatologists will review clinical exam information and 3 high quality digital images for each lesion without MelaFind result.
803070|NCT01387542|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
803071|NCT01387542|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
803072|NCT01387542|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
803878|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
803076|NCT01387542|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator’s discretion once daily for 10 weeks
803077|NCT01387464|B3|Baseline|Total|Total of all reporting groups
803078|NCT01387464|B2|Baseline|Bromday|0.09% bromfenac dosed QD
803079|NCT01387464|B1|Baseline|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
803080|NCT01387464|P2|Participant Flow|Bromday|0.09% bromfenac dosed QD
803081|NCT01387464|P1|Participant Flow|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
803082|NCT01387464|O2|Outcome|Bromday|0.09% bromfenac dosed QD
803083|NCT01387464|O1|Outcome|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
803084|NCT01387464|E2|Reported Event|Bromday|0.09% bromfenac dosed QD
803085|NCT01387464|E1|Reported Event|ISV-303|0.075% bromfenac in DuraSite vehicle dosed QD
803086|NCT01387347|B3|Baseline|Total|Total of all reporting groups
803087|NCT01387347|B2|Baseline|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
803088|NCT01387347|B1|Baseline|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
803089|NCT01387347|P2|Participant Flow|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4.~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
803090|NCT01387347|P1|Participant Flow|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
803091|NCT01387347|O2|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye twice a day for 29 days.
803092|NCT01387347|O1|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 (w/w) for direct instillation into each eye twice a day for 29 days.
803093|NCT01387347|O2|Outcome|Thymosin Beta 4|Thymosin beta 4 solution is a sterile eye drop solution containing 0.1%(w/w) Tβ4. Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
803094|NCT01387347|O1|Outcome|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
803095|NCT01387347|O2|Outcome|Placebo|Placebo is a preservative-free, sterile eye drop solution containing 0% Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0% Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
803096|NCT01387347|O1|Outcome|Thymosin Beta 4|RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
803097|NCT01387347|E2|Reported Event|Thymosin Beta 4|"RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4~Thymosin beta 4 : A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
803098|NCT01387347|E1|Reported Event|Placebo|"The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.~Placebo : A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days."
803099|NCT01387230|B4|Baseline|Total|Total of all reporting groups
803100|NCT01387230|B3|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
803101|NCT01387230|B2|Baseline|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
803102|NCT01387230|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
803103|NCT01387230|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
803104|NCT01387230|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
803105|NCT01387230|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12 weeks.
803106|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
803107|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
803108|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
803109|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
803110|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
803111|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
803112|NCT01387230|O3|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
803113|NCT01387230|O2|Outcome|UMEC 62.5 µg|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
803114|NCT01387230|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
803115|NCT01387230|E3|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
803117|NCT01387230|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
803118|NCT01387178|B3|Baseline|Total|Total of all reporting groups
803119|NCT01387178|B2|Baseline|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
803120|NCT01387178|B1|Baseline|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
803121|NCT01387178|P2|Participant Flow|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for tiotropium bromide (TIO)
803122|NCT01387178|P1|Participant Flow|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Edition, Clinical Modification [ICD-9-CM] code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for fluticasone/propionate 250 µg /50 µg (FSC)
803123|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
803124|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
803125|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with &gt;=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), &gt;=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), &gt;=1 in the post-index date observation period, and &gt;=1 prescription claim for TIO
803126|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
803127|NCT01387178|O2|Outcome|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
803128|NCT01387178|O1|Outcome|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
803129|NCT01387178|E2|Reported Event|Tiotropium Bromide 18 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for TIO
803130|NCT01387178|E1|Reported Event|Fluticasone Propionate/Salmeterol 250 Micrograms (µg)/50 µg|Participants 40 years of age or older with >=2 medical claims with a primary or non-primary diagnosis of COPD (ICD-9-CM code 490.xx, 491.xx, 492.xx, or 496.xx), >=1 in the 12 months prior to the index date (defined as the first pharmacy claim for the study drug), >=1 in the post-index date observation period, and >=1 prescription claim for FSC
803131|NCT01387139|B3|Baseline|Total|Total of all reporting groups
803132|NCT01387139|B2|Baseline|Ketamine Co-Administered With Propofol|
803133|NCT01387139|B1|Baseline|Ketamine Alone|
803134|NCT01387139|P2|Participant Flow|Ketamine Co-Administered With Propofol|Ketamine Co-administered with Propofol: 0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
803135|NCT01387139|P1|Participant Flow|Ketamine Alone|Ketamine: 1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
803136|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
803137|NCT01387139|O1|Outcome|Ketamine Alone|
803138|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
803139|NCT01387139|O1|Outcome|Ketamine Alone|
803140|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
803141|NCT01387139|O1|Outcome|Ketamine Alone|
803142|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
803143|NCT01387139|O1|Outcome|Ketamine Alone|
803144|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
803145|NCT01387139|O1|Outcome|Ketamine Alone|
803146|NCT01387139|O2|Outcome|Ketamine Co-Administered With Propofol|
803147|NCT01387139|O1|Outcome|Ketamine Alone|
803148|NCT01387139|E2|Reported Event|Ketamine Co-Administered With Propofol|
803149|NCT01387139|E1|Reported Event|Ketamine Alone|
803879|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
803150|NCT01387074|B1|Baseline|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803151|NCT01387074|P1|Participant Flow|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803152|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803153|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803154|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803155|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803156|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803157|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803158|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803159|NCT01387074|O1|Outcome|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803160|NCT01387074|E1|Reported Event|Botulinum Toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
803161|NCT01387022|B3|Baseline|Total|Total of all reporting groups
803162|NCT01387022|B2|Baseline|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803163|NCT01387022|B1|Baseline|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803164|NCT01387022|P2|Participant Flow|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803165|NCT01387022|P1|Participant Flow|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803166|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803167|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803168|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803169|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803170|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803171|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803172|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803173|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803174|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803175|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803176|NCT01387022|O2|Outcome|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803177|NCT01387022|O1|Outcome|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803178|NCT01387022|E2|Reported Event|Tenofovir-sparing Regimen|Patients were initiated on EFV,FTC/3TC,ZDV
803179|NCT01387022|E1|Reported Event|Tenofovir-containing Regimen|Patients were initiated on EFV, FTC/3TC,TDF
803180|NCT01386983|B3|Baseline|Total|Total of all reporting groups
803181|NCT01386983|B2|Baseline|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
803182|NCT01386983|B1|Baseline|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
803183|NCT01386983|P2|Participant Flow|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
803184|NCT01386983|P1|Participant Flow|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
803185|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
803186|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
803187|NCT01386983|O2|Outcome|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
803188|NCT01386983|O1|Outcome|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
803189|NCT01386983|E2|Reported Event|Delayed Cohort|Participants who began a 5ARI 30 days after an AB but within 180 days (late combination users)
803227|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
803880|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
803228|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
803235|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803190|NCT01386983|E1|Reported Event|Early Cohort|Participants treated either (1) only with a 5-alpha reductase inhibitor (5ARI) (monotherapy 5ARI users [dutasteride and finasteride]) (mono ARI users) or with (2) a 5ARI within 30 days of an alpha-adrenergic blocker (AB [doxazosin, tamsulosin, terazosin, and alfuzosin]) (early combination users)
803191|NCT01386944|B1|Baseline|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803192|NCT01386944|P1|Participant Flow|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803193|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803194|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803195|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803196|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803197|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803198|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803199|NCT01386944|O1|Outcome|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803200|NCT01386944|E1|Reported Event|Neupro® Treatment|Routine treatment (1,2,3 mg/24 h) as per approved label in the European Union (EU).
803201|NCT01386788|B1|Baseline|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
803202|NCT01386788|P1|Participant Flow|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
803203|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
803204|NCT01386788|O1|Outcome|Smoke Inhalation Victims|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed.
803205|NCT01386788|E1|Reported Event|Smoke Inhalation Victim|Smoke inhalation victims included civil victims and fire workers as specified in the inclusion criteria were observed
803206|NCT01386632|B3|Baseline|Total|Total of all reporting groups
803207|NCT01386632|B2|Baseline|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
803208|NCT01386632|B1|Baseline|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
803209|NCT01386632|P2|Participant Flow|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
803210|NCT01386632|P1|Participant Flow|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
803211|NCT01386632|O2|Outcome|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
803212|NCT01386632|O1|Outcome|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
803213|NCT01386632|O2|Outcome|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
803214|NCT01386632|O1|Outcome|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
803215|NCT01386632|E2|Reported Event|Placebo|Placebo: Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
803216|NCT01386632|E1|Reported Event|DCA (Dichloroacetate) Treatment|"DCA orally 12.5mg/kg or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60 minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)~DCA (dichloroacetate): DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)"
803217|NCT01386606|B5|Baseline|Total|Total of all reporting groups
803218|NCT01386606|B4|Baseline|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
803219|NCT01386606|B3|Baseline|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803220|NCT01386606|B2|Baseline|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803221|NCT01386606|B1|Baseline|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803222|NCT01386606|P4|Participant Flow|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
803223|NCT01386606|P3|Participant Flow|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803224|NCT01386606|P2|Participant Flow|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803225|NCT01386606|P1|Participant Flow|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803226|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
803409|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
803236|NCT01386606|O3|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
803237|NCT01386606|O2|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
803238|NCT01386606|O1|Outcome|Androxal 6.25 mg|"Androxal 6.25 mg/day~Androxal (enclomiphene citrate): capsule oral~1X a day 6 weeks"
803239|NCT01386606|O1|Outcome|Androxal Pooled Dose Levels|Androxal 6.25, 12.5, and 25 mg subjects combined into a single group.
803240|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
803241|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803242|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803243|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803244|NCT01386606|O4|Outcome|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
803245|NCT01386606|O3|Outcome|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803246|NCT01386606|O2|Outcome|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803247|NCT01386606|O1|Outcome|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803248|NCT01386606|E4|Reported Event|AndroGel|"AndroGel 5G topical testosterone~Testosterone: topical gel~1X a day 6 weeks"
803249|NCT01386606|E3|Reported Event|Androxal 25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803250|NCT01386606|E2|Reported Event|Androxal 12.5 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803251|NCT01386606|E1|Reported Event|Androxal 6.25 mg|"enclomiphene citrate: capsule oral~1X a day 6 weeks"
803252|NCT01386125|B3|Baseline|Total|Total of all reporting groups
803253|NCT01386125|B2|Baseline|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
803254|NCT01386125|B1|Baseline|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
803255|NCT01386125|P2|Participant Flow|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
803256|NCT01386125|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Participants receive mometasone furoate nasal spray (MFNS) 200 mcg twice daily (BID) for 16 weeks
803257|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
803258|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
803259|NCT01386125|O2|Outcome|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
803260|NCT01386125|O1|Outcome|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
803261|NCT01386125|E2|Reported Event|Placebo|Participants receive matching placebo nasal spray BID for 16 weeks
803262|NCT01386125|E1|Reported Event|MFNS|Participants receive MFNS 200 mcg BID for 16 weeks
803263|NCT01386008|B1|Baseline|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
803264|NCT01386008|P1|Participant Flow|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
803265|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
803266|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
803267|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
803268|NCT01386008|O1|Outcome|Enfilcon A + Senofilcon A|Simultaneous wearing of daily wear contact lenses - investigational enfilcon A contact lenses in one eye and comparator senofilcon A worn in the other
803269|NCT01386008|E1|Reported Event|Overall Study Group|investigational enfilcon A contact lenses worn daily wear and senofilcon A contact lens worn daily wear
803270|NCT01385995|B3|Baseline|Total|Total of all reporting groups
803271|NCT01385995|B2|Baseline|Sham-Continuous Positive Airway Pressure|
803272|NCT01385995|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|
803273|NCT01385995|P2|Participant Flow|Sham-Continuous Positive Airway Pressure|
803274|NCT01385995|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|
803275|NCT01385995|O2|Outcome|Sham CPAP|
803276|NCT01385995|O1|Outcome|Therapeutic CPAP|
803277|NCT01385995|O2|Outcome|Sham CPAP|
803278|NCT01385995|O1|Outcome|Therapeutic CPAP|
803279|NCT01385995|O2|Outcome|Sham CPAP|
803280|NCT01385995|O1|Outcome|Therapeutic CPAP|
803281|NCT01385995|O2|Outcome|Sham CPAP|
803282|NCT01385995|O1|Outcome|Therapeutic CPAP|
803283|NCT01385995|O2|Outcome|Sham CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after sham CPAP therapy, in total sample, with the sham periods of both sequences combined.
803284|NCT01385995|O1|Outcome|Therapeutic CPAP|Assessment of number of subjects with normalization of oral glucose tolerance test from baseline after therapeutic CPAP therapy, in total sample, with the active periods of both sequences combined.
803285|NCT01385995|E2|Reported Event|Sham-Continuous Positive Airway Pressure|
803286|NCT01385995|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|
803287|NCT01385696|B1|Baseline|Overall Study Safety Population|All patients randomized into the study excluding 1 patient who used Handihaler® once only, Genuair® zero times, & was excluded from the safety population
803288|NCT01385696|P2|Participant Flow|Placebo HandiHaler (Daily) Then Placebo Genuair (Daily)|Each morning, patients used the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo followed by the Genuair® (Almirall S.A.) inhaler containing placebo. The study period consisted of 1 period of 14 days.
803289|NCT01385696|P1|Participant Flow|Placebo Genuair (Daily) Then Placebo HandiHaler (Daily)|Each morning, patients used the Genuair® (Almirall S.A.) inhaler containing placebo followed by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo. The study period consisted of 1 period of 14 days.
803290|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
803291|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
803292|NCT01385696|O2|Outcome|Handihaler Inhaler|Intention-to-treat (ITT) population
803293|NCT01385696|O1|Outcome|Genuair Inhaler|Intention-to-treat (ITT) population
803294|NCT01385696|O1|Outcome|Overall Intention-to-treat Population|Overall intention-to-treat (ITT) population
803295|NCT01385696|E2|Reported Event|HandiHaler Then Genuair|The study period consisted of 1 period of 14 days. Every morning patients used the HandiHaler® (Boehringer Ingelheim)inhaler containing placebo follow by the Genuair® (Almirall S.A.) inhaler containing placebo.
803296|NCT01385696|E1|Reported Event|Genuair Then HandiHaler|The study period consisted of 1 period of 14 days. Every morning patients used the Genuair® (Almirall S.A.) inhaler containing placebo follow by the HandiHaler® (Boehringer Ingelheim) inhaler containing placebo.
803297|NCT01385644|B3|Baseline|Total|Total of all reporting groups
803298|NCT01385644|B2|Baseline|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803299|NCT01385644|B1|Baseline|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803300|NCT01385644|P2|Participant Flow|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803301|NCT01385644|P1|Participant Flow|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803302|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803303|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803304|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803305|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803306|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803307|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803308|NCT01385644|O2|Outcome|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803309|NCT01385644|O1|Outcome|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803310|NCT01385644|E2|Reported Event|2*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803896|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
803311|NCT01385644|E1|Reported Event|1*10^6 MSC / kg|"Placental MSC~Placental MSC: MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients."
803312|NCT01385579|B3|Baseline|Total|Total of all reporting groups
803313|NCT01385579|B2|Baseline|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
803314|NCT01385579|B1|Baseline|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
803315|NCT01385579|P2|Participant Flow|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
803316|NCT01385579|P1|Participant Flow|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
803317|NCT01385579|O2|Outcome|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
803318|NCT01385579|O1|Outcome|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
803319|NCT01385579|E2|Reported Event|Care Manager Outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit
803320|NCT01385579|E1|Reported Event|Usual Care|Patients assigned to the usual care arm may be referred for colorectal cancer screening by their providers per usual health center protocol and practice. They receive no additional outreach by the preventive care care manager.
803321|NCT01385566|B7|Baseline|Total|Total of all reporting groups
803322|NCT01385566|B6|Baseline|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803323|NCT01385566|B5|Baseline|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803324|NCT01385566|B4|Baseline|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803325|NCT01385566|B3|Baseline|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803326|NCT01385566|B2|Baseline|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803327|NCT01385566|B1|Baseline|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803328|NCT01385566|P6|Participant Flow|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803329|NCT01385566|P5|Participant Flow|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803330|NCT01385566|P4|Participant Flow|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803331|NCT01385566|P3|Participant Flow|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803332|NCT01385566|P2|Participant Flow|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803454|NCT01385137|B1|Baseline|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803333|NCT01385566|P1|Participant Flow|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803334|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803335|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803336|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803337|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803338|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803339|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803340|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803341|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803342|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803343|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803344|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803345|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803346|NCT01385566|O7|Outcome|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Participants in this group were included in the analyses for the V211 treatment groups, and are replicated here specifically to report injection-site adverse experiences reported for the limb receiving a placebo injection.
803347|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803348|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803349|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803350|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803410|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
803351|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803352|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803897|NCT01382719|E4|Reported Event|Bremelanotide Arm 3|high dose 1.75 mg BMT
803353|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803354|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803355|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803356|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803357|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803358|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803359|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803360|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803361|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803362|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803363|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803364|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803365|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803366|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803367|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803368|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803369|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803370|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803411|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
803412|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
803413|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
803414|NCT01385293|O1|Outcome|BKM 120|BKM120 at 100mg orally daily
803371|NCT01385566|O6|Outcome|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803455|NCT01385137|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803372|NCT01385566|O5|Outcome|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803373|NCT01385566|O4|Outcome|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803374|NCT01385566|O3|Outcome|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803375|NCT01385566|O2|Outcome|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803376|NCT01385566|O1|Outcome|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803377|NCT01385566|E7|Reported Event|Placebo|On Day 1 of the study, participants will receive a dose of ZOSTAVAX™ administered in one limb according to their randomized treatment group, and a dose of saline placebo in the alternate limb. Only injection-site adverse events occurring in the placebo limb are reported; systemic adverse events are reported by V211 treatment group only.
803378|NCT01385566|E6|Reported Event|1/27 Dose Intradermal|Participants will receive a 1/27 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803379|NCT01385566|E5|Reported Event|1/10 Dose Intradermal|Participants will receive a 1/10 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803380|NCT01385566|E4|Reported Event|1/3 Dose Intradermal|Participants will receive a 1/3 dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803381|NCT01385566|E3|Reported Event|Full Dose Intradermal|Participants will receive a full dose of ZOSTAVAX™ administered intradermally on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803382|NCT01385566|E2|Reported Event|1/3 Dose Subcutaneous|Participants will receive a 1/3 dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Six participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1. Participants will have the option to receive a full subcutaneous dose of ZOSTAVAX™ after completion of the study.
803383|NCT01385566|E1|Reported Event|Full Dose Subcutaneous|Participants will receive a full dose of ZOSTAVAX™ administered subcutaneously on Day 1 of the study. Nine participants in this group will also receive saline placebo intradermally in the alternate limb on Day 1.
803384|NCT01385371|B3|Baseline|Total|Total of all reporting groups
803385|NCT01385371|B2|Baseline|Placebo|Participants receiving Placebo
803386|NCT01385371|B1|Baseline|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803387|NCT01385371|P2|Participant Flow|Placebo|Participants receiving Placebo
803388|NCT01385371|P1|Participant Flow|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803389|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803390|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803391|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803392|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803393|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803394|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803395|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803396|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803397|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803398|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803399|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803400|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803401|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803402|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803403|NCT01385371|O2|Outcome|Placebo|Participants receiving Placebo
803404|NCT01385371|O1|Outcome|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803405|NCT01385371|E2|Reported Event|Placebo|Participants receiving Placebo
803406|NCT01385371|E1|Reported Event|SCH 697243|Participants receiving Grass (Phleum pratense) Pollen Allergen Extract
803407|NCT01385293|B1|Baseline|BKM 120|BKM120 at 100mg orally daily
803408|NCT01385293|P1|Participant Flow|BKM 120|BKM120 at 100mg orally daily
803417|NCT01385202|B1|Baseline|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
803418|NCT01385202|P1|Participant Flow|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
803419|NCT01385202|O2|Outcome|Calibration Roll-in|Calibration roll-in case(s) is intended to calibrate an investigator’s tactile feel, catheter manipulation technique, and use of other surrogate measures (electrogram signal, impedance, etc.) during the procedure.
803420|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter-Effective Cohort|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter.
803421|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
803422|NCT01385202|O1|Outcome|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
803423|NCT01385202|E1|Reported Event|THERMOCOOL® SMARTTOUCH™ Catheter|THERMOCOOL® SMARTTOUCH™ Deflectable Diagnostic/Ablation Catheter
803424|NCT01385189|B6|Baseline|Total|Total of all reporting groups
803425|NCT01385189|B5|Baseline|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803426|NCT01385189|B4|Baseline|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
803427|NCT01385189|B3|Baseline|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803428|NCT01385189|B2|Baseline|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803429|NCT01385189|B1|Baseline|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803430|NCT01385189|P5|Participant Flow|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803431|NCT01385189|P4|Participant Flow|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
803432|NCT01385189|P3|Participant Flow|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803433|NCT01385189|P2|Participant Flow|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803434|NCT01385189|P1|Participant Flow|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803435|NCT01385189|O7|Outcome|100 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
803436|NCT01385189|O6|Outcome|100 µg Na-GST-1/Alhydrogel|
803437|NCT01385189|O5|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (5 µg)|
803438|NCT01385189|O4|Outcome|30 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
803439|NCT01385189|O3|Outcome|30 µg Na-GST-1/Alhydrogel|
803440|NCT01385189|O2|Outcome|10 µg Na-GST-1/Alhydrogel/GLA-AF (1 µg)|
803441|NCT01385189|O1|Outcome|10 μg Na-GST-1/Alhydrogel|
803442|NCT01385189|O5|Outcome|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803443|NCT01385189|O4|Outcome|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
803444|NCT01385189|O3|Outcome|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803445|NCT01385189|O2|Outcome|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803446|NCT01385189|O1|Outcome|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803447|NCT01385189|E5|Reported Event|Cohort 5|"100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803448|NCT01385189|E4|Reported Event|Cohort 4|"100 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~100 μg Na-GST-1/Alhydrogel: 3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals"
803449|NCT01385189|E3|Reported Event|Cohort 3|"30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)~30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg): 3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals"
803450|NCT01385189|E2|Reported Event|Cohort 2|"30 μg Na-GST-1/Alhydrogel vs. 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~30 μg Na-GST-1/Alhydrogel: 3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals~30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803451|NCT01385189|E1|Reported Event|Cohort 1|"10 μg Na-GST-1/Alhydrogel vs. 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)~10 μg Na-GST-1/Alhydrogel: 3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals~10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg): 3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals"
803452|NCT01385137|B3|Baseline|Total|Total of all reporting groups
803881|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
803453|NCT01385137|B2|Baseline|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803814|NCT01383096|E5|Reported Event|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
803456|NCT01385137|P1|Participant Flow|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803457|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803458|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803459|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803460|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803461|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803462|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803463|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803464|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803465|NCT01385137|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803466|NCT01385137|O1|Outcome|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803467|NCT01385137|E2|Reported Event|Arm II (Placebo)|Patients receive oral placebo BID or TID for 24 weeks in the absence of disease progression or unacceptable toxicity
803468|NCT01385137|E1|Reported Event|Arm I (Omega-3-fatty Acid)|Patients receive oral omega-3-fatty acid twice daily (BID) or three times daily (TID) for 24 weeks in the absence of disease progression or unacceptable toxicity
803469|NCT01385033|B3|Baseline|Total|Total of all reporting groups
803470|NCT01385033|B2|Baseline|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
803471|NCT01385033|B1|Baseline|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
803472|NCT01385033|P6|Participant Flow|Amnestic Mild Cognitive Impairment Participants (Part III)|Participants with amnestic Mild Cognitive Impairment received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part III)
803473|NCT01385033|P5|Participant Flow|Healthy Young (HY) Participants (Part II)|HY participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
803474|NCT01385033|P4|Participant Flow|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
803475|NCT01385033|P3|Participant Flow|AD Participants (Part II)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by PET imaging of the brain (Part II)
803476|NCT01385033|P2|Participant Flow|Healthy Elderly (HE) Participants (Part I)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part I)
803477|NCT01385033|P1|Participant Flow|Alzheimer's Disease (AD) Participants (Part I)|AD participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by positron emission tomography (PET) imaging of the brain (Part I)
803478|NCT01385033|O1|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
803479|NCT01385033|O2|Outcome|HE Participants|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
803480|NCT01385033|O1|Outcome|AD Participants|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
803481|NCT01385033|O1|Outcome|AD and HE Participants|AD and HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
803482|NCT01385033|E1|Reported Event|All Study Participants|Participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain
803483|NCT01384760|B3|Baseline|Total|Total of all reporting groups
803484|NCT01384760|B2|Baseline|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
803485|NCT01384760|B1|Baseline|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
803516|NCT01384019|E2|Reported Event|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
803882|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
803486|NCT01384760|P2|Participant Flow|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
803815|NCT01383096|E4|Reported Event|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
803487|NCT01384760|P1|Participant Flow|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
803488|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
803489|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
803490|NCT01384760|O2|Outcome|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
803491|NCT01384760|O1|Outcome|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
803492|NCT01384760|E2|Reported Event|Simple Lifestyle Advice|Simple lifestyle advice: Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
803493|NCT01384760|E1|Reported Event|Lifestyle Modification Program|Lifestyle modification: During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
803494|NCT01384292|B4|Baseline|Total|Total of all reporting groups
803495|NCT01384292|B3|Baseline|Placebo|Placebo, oral treatment
803496|NCT01384292|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
803497|NCT01384292|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
803498|NCT01384292|P3|Participant Flow|Placebo|Placebo, oral treatment
803499|NCT01384292|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
803500|NCT01384292|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
803501|NCT01384292|O3|Outcome|Placebo|Placebo, oral treatment
803502|NCT01384292|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg, oral treatment
803503|NCT01384292|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 mg, oral treatment
803504|NCT01384292|E5|Reported Event|NKTR-118 25 mg - Part B|Part B NKTR-118 25 mg, oral treatment
803505|NCT01384292|E4|Reported Event|NKTR-118 12.5 mg - Part B|Part B NKTR-118 12.5 mg, oral treatment
803506|NCT01384292|E3|Reported Event|Placebo - Part A|Part A Placebo, oral treatment
803507|NCT01384292|E2|Reported Event|NKTR-118 25 mg - Part A|Part A NKTR-118 25 mg, oral treatment
803508|NCT01384292|E1|Reported Event|NKTR-118 12.5 mg - Part A|Part A NKTR-118 12.5 mg, oral treatment
803509|NCT01384019|B3|Baseline|Total|Total of all reporting groups
803510|NCT01384019|B2|Baseline|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
803511|NCT01384019|B1|Baseline|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
803512|NCT01384019|P2|Participant Flow|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
803513|NCT01384019|P1|Participant Flow|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
803514|NCT01384019|O2|Outcome|c-PCI|conventional PCI without DP-TA during primary percutaneous coronary intervention for ST-elevation myocardial infarction
803515|NCT01384019|O1|Outcome|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
803883|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
803517|NCT01384019|E1|Reported Event|DP-TA|distal protection and thrombus aspiration during primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI)
803518|NCT01383993|B4|Baseline|Total|Total of all reporting groups
803891|NCT01382719|O2|Outcome|Bremelanotide Arm 1|low dose 0.75 mg BMT
803519|NCT01383993|B3|Baseline|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803520|NCT01383993|B2|Baseline|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803521|NCT01383993|B1|Baseline|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803522|NCT01383993|P3|Participant Flow|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803523|NCT01383993|P2|Participant Flow|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803524|NCT01383993|P1|Participant Flow|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803525|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803526|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803527|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803528|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803529|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803530|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803674|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803727|NCT01383213|P1|Participant Flow|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
803694|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803531|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803532|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803533|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803534|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803535|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803536|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803537|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803538|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803539|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803540|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803541|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803542|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803543|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803884|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
803544|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803545|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803546|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803547|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803548|NCT01383993|O1|Outcome|All Participants|Immunocompromised children aged 2 to <15 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg or 6 mg/kg on Day 1 and 8 mg/kg or 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg or 200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803549|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803550|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803551|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803552|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803553|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803554|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803555|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803556|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803675|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803557|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803558|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803559|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803560|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803561|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803562|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803563|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803564|NCT01383993|O3|Outcome|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803565|NCT01383993|O2|Outcome|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803566|NCT01383993|O1|Outcome|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803567|NCT01383993|E3|Reported Event|Participants Aged 12 to<15 Years and Weighed ≥50 kg|Immunocompromised children aged 12 to <15 years and weighed greater than or equal to 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (6 mg/kg on Day 1 and 4 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (200 mg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803568|NCT01383993|E2|Reported Event|Participants Aged 12 to<15 Years and Weighed <50 kg|Immunocompromised children aged 12 to <15 years and weighed less than 50 kg who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803569|NCT01383993|E1|Reported Event|Participants Aged 2 to <12 Years|Immunocompromised children aged 2 to <12 years who are at high risk for systemic fungal infection. Voriconazole intravenous (IV) multiple dose (9 mg/kg on Day 1 and 8 mg/kg on Day 2 to 7 once every 12 hours) was administered in the morning and evening (up to Day 20 or more if clinically indicated). The oral dosing regimen (9 mg/kg every 12 hours) was administered following voriconazole IV in the morning and evening and lasted 6.5 days (up to Day 30 if clinically indicated).
803570|NCT01383928|B4|Baseline|Total|Total of all reporting groups
803885|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
803571|NCT01383928|B3|Baseline|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803572|NCT01383928|B2|Baseline|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803573|NCT01383928|B1|Baseline|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803574|NCT01383928|P3|Participant Flow|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803575|NCT01383928|P2|Participant Flow|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803576|NCT01383928|P1|Participant Flow|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803577|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803578|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803579|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803676|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803677|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803754|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803580|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803581|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803582|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803583|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803584|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803585|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803586|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803587|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803678|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803679|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803680|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803588|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803589|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803590|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803591|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803592|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803593|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803594|NCT01383928|O1|Outcome|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803595|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803596|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803681|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803682|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803597|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803598|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803599|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803600|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803601|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving the same dose of ixazomib (MLN9708) capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803602|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803603|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803604|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803605|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803683|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803684|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803859|NCT01382901|E1|Reported Event|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
803606|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803607|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803608|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803609|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803610|NCT01383928|O2|Outcome|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803611|NCT01383928|O1|Outcome|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803612|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803613|NCT01383928|O1|Outcome|Phase 1: All Participants|Ixazomib 3 mg or 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803614|NCT01383928|E3|Reported Event|Phase 2: Ixazomib 3 mg|Ixazomib 3 mg (MLN9708), capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 2. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803685|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803686|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803860|NCT01382719|B5|Baseline|Total|Total of all reporting groups
803861|NCT01382719|B4|Baseline|Bremelanotide Arm 3|high dose 1.75 mg BMT
803615|NCT01383928|E2|Reported Event|Phase 1: Ixazomib 3.7 mg|Ixazomib (MLN9708) 3.7 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3.7 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803616|NCT01383928|E1|Reported Event|Phase 1: Ixazomib 3 mg|Ixazomib (MLN9708) 3 mg, capsules, orally, twice-weekly on Days 1, 4, 8, and 11, lenalidomide 25 mg, capsules, orally, once daily on Days 1-14, dexamethasone 20 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 1-8 and dexamethasone 10 mg, capsules, orally, once daily on Days 1, 2, 4, 5, 8, 9, 11, and 12 in Cycle 9-16 in 21-day treatment cycles for up to 16 cycles in the absence of disease progression or unacceptable toxicity as induction therapy during Phase 1. Participants with stable or responding disease continued receiving ixazomib (MLN9708) 3 mg, capsules, orally, twice weekly on Days 1, 4, 8, and 11 in 21-day treatment cycles as maintenance therapy until progressive disease or unacceptable toxicity.
803617|NCT01383720|B1|Baseline|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803618|NCT01383720|P1|Participant Flow|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803619|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803620|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803621|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803622|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803623|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803624|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803625|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803626|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803627|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803628|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803629|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803630|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803631|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803632|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803633|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803634|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803635|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803636|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803637|NCT01383720|O1|Outcome|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803638|NCT01383720|E1|Reported Event|Lotus Valve System|Patients enrolled in the study to receive treatment with the Lotus Valve System for symptomatic aortic valve stenosis
803639|NCT01383707|B1|Baseline|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803687|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803688|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803689|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803690|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803862|NCT01382719|B3|Baseline|Bremelanotide Arm 2|middle dose 1.25 mg BMT
803640|NCT01383707|P1|Participant Flow|Bevacizumab + Modified FOLFOX-6 (mFOLFOX-6)|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803641|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803642|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803643|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803644|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803645|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803646|NCT01383707|O1|Outcome|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803691|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803692|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803863|NCT01382719|B2|Baseline|Bremelanotide Arm 1|low dose 0.75 mg BMT
803647|NCT01383707|E1|Reported Event|Bevacizumab + mFOLFOX-6|Combination therapy of bevacizumab and mFOLFOX-6 (Levofolinic acid, 5-Fluorouracil [5-FU], oxaliplatin) on Day 1 of every 2 weeks' cycle for 5 cycles (Cycle 1-5), followed by 1 cycle (Cycle 6) of mFOLFOX6 alone (preoperative treatment phase). After 3 weeks of preoperative treatment phase, participants satisfying the surgical criteria for hepatic resectability will undergo a liver metastasectomy. Thereafter participants will receive combination therapy of mFOLFOX-6 + bevacizumab for another 6 cycles (Cycle 7-12); (post-operative treatment phase) followed by bevacizumab alone for 52 weeks (26 cycles) (maintenance therapy). 5-FU: 400 mg/meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours; Bevacizumab: 5 mg/kg IV on Day 1 of each 2 weeks' cycle; Levofolinic acid: 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle; Oxaliplatin: 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle
803648|NCT01383681|B1|Baseline|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
803649|NCT01383681|P1|Participant Flow|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
803650|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
803651|NCT01383681|O1|Outcome|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
803652|NCT01383681|E1|Reported Event|All Participants|This was a retrospective chart review in patients with spasticity in the Spanish population. There was no treatment in this study.
803653|NCT01383499|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
803654|NCT01383499|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Period 1, with Tiotropium 1.25 mcg in Period 2 and with Placebo in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
803655|NCT01383499|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with Placebo in Period 1, with Tiotropium 2.5 mcg in Period 2 and with Tiotropium 5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
803656|NCT01383499|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Period 1, with Tiotropium 5 mcg in Period 2 and with Tiotropium 2.5 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
803657|NCT01383499|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Period 1, with Placebo in Period 2 and with Tiotropium 1.25 mcg in Period 3. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off treatment periods) between treatments.
803658|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803659|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803660|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803661|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803662|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803663|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803664|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803665|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803666|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803667|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803668|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803669|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803670|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803671|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803672|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803673|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803693|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803695|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803696|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 mcg once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803697|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803698|NCT01383499|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803699|NCT01383499|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803700|NCT01383499|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803701|NCT01383499|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803702|NCT01383499|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803703|NCT01383499|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803704|NCT01383499|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803705|NCT01383499|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
803706|NCT01383486|B1|Baseline|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
803707|NCT01383486|P1|Participant Flow|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and 20 Aleve 24 Hour extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
803708|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
803709|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
803710|NCT01383486|O1|Outcome|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
803711|NCT01383486|E1|Reported Event|Naproxen Sodium ER (BAY H6689) or Advil IR|Eligible subjects were provided with 24 Advil IR caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.
803712|NCT01383356|B1|Baseline|Entire Study Population|Total number of subjects randomised and treated in the study.
803713|NCT01383356|P2|Participant Flow|Lina 2.5mg Plus Met 500mg Then Lina/Met 2.5mg/500mg|Single tablets Linagliptin 2.5mg plus Metformin 500mg followed by combination tablet Linagliptin/Metformin 2.5mg/500mg
803714|NCT01383356|P1|Participant Flow|Lina/Met 2.5mg/500mg Then Lina 2.5mg Plus Met 500mg|Combination tablet Linagliptin (Lina) /Metformin (Met) 2.5mg/500mg followed by single tablets Linagliptin 2.5mg plus Metformin 500mg
803715|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
803716|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
803717|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
803718|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
803719|NCT01383356|O2|Outcome|Lina 2.5mg Plus Met 500mg|Single tablets
803720|NCT01383356|O1|Outcome|Lina/Met 2.5mg/500mg|Combination tablet
803721|NCT01383356|E2|Reported Event|Lina 2.5mg Plus Met 500mg|Single tablets
803722|NCT01383356|E1|Reported Event|Lina/Met 2.5mg/500mg|Combination tablet
803723|NCT01383213|B3|Baseline|Total|Total of all reporting groups
803724|NCT01383213|B2|Baseline|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
803725|NCT01383213|B1|Baseline|CPAP (Group A)|group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%
803726|NCT01383213|P2|Participant Flow|Oxygen Therapy (Group B)|group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.
803779|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803728|NCT01383213|O2|Outcome|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
803729|NCT01383213|O1|Outcome|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
803730|NCT01383213|E2|Reported Event|Oxygen Therapy (Group B)|"group B (standard treatment) will be treated with oxygen therapy by Venturi mask with an FiO2 set in order to maintain SpO2 ≥92%.~Oxygen therapy: patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation"
803731|NCT01383213|E1|Reported Event|CPAP (Group A)|"group A will be treated with CPAP using a helmet, initial PEEP of 10 cmH20 and an FiO2 set in order to maintain SpO2 ≥92%~Helmet CPAP: patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation"
803732|NCT01383200|B3|Baseline|Total|Total of all reporting groups
803733|NCT01383200|B2|Baseline|TetracaineLeft Eye /LidocaineRight Eye|0.5% tetracaine drops Left eye / 2% lidocaine gel Right eye
803734|NCT01383200|B1|Baseline|TetracaineRight Eye / LidocaineLeft Eye|0.5% tetracaine drops Right eye /2% lidocaine gel Left eye
803735|NCT01383200|P2|Participant Flow|Tetracaine Left Eye / Lidocaine Right Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 20% lidocaine gel."
803736|NCT01383200|P1|Participant Flow|Tetracaine Right Eye / Lidocaine Left Eye|"Each eye of the Subject was randomized using random number tables to receive either topical 0.5% tetracaine drops or 20% lidocaine gel~11 eyes received 0.5% tetracaine drops."
803737|NCT01383200|O2|Outcome|Lidocaine|2% lidocaine gel
803738|NCT01383200|O1|Outcome|Tetracaine|0.5% tetracaine drops
803739|NCT01383200|E2|Reported Event|Tetracaine Left Eye / Lidocaine Right Eye|0.5% Tetracaine Left eye / 2% Lidocaine Right eye
803740|NCT01383200|E1|Reported Event|Tetracaine Right Eye / Lidocaine Left Eye|0.5% Tetracaine drops Right eye / 2% Lidocaine Left eye
803741|NCT01383174|B3|Baseline|Total|Total of all reporting groups
803742|NCT01383174|B2|Baseline|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803743|NCT01383174|B1|Baseline|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803744|NCT01383174|P2|Participant Flow|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803745|NCT01383174|P1|Participant Flow|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803746|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803747|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803748|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803749|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803750|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803751|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803752|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803753|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803755|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803756|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803757|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803758|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803759|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803760|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803761|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803762|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803763|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803764|NCT01383174|O2|Outcome|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803765|NCT01383174|O1|Outcome|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803766|NCT01383174|E2|Reported Event|Wait-list Control|Waits six months, and at the end of the six months is offered the option of participating in the peer support program.
803767|NCT01383174|E1|Reported Event|Nuevo Amanecer Peer Support Program|"Nuevo Amanecer is a cognitive-behavioral stress management program delivered by peers (Spanish-speaking Latinas who have had breast cancer) designed to address the first year of survivorship.~Peer Support Program:~Work with a trained counselor who is a breast cancer survivor~Meet 8 times in-person over the 8 week program with the counselor~Counselor helps participant develop a personalized support program to help her improve her quality of life~Receives information on breast cancer, its treatments, stress management, and cognitive refraining."
803768|NCT01383096|B4|Baseline|Total|Total of all reporting groups
803769|NCT01383096|B3|Baseline|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
803770|NCT01383096|B2|Baseline|Cohort 2|Subjects received a single dose of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
803771|NCT01383096|B1|Baseline|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
803772|NCT01383096|P3|Participant Flow|Cohort 3|Subjects received a 800mg single dose of OZ439 prototype solution formulation 1 fasted and then a 400mg single dose of OZ439 of prototype solution formulation 1 fasted.
803773|NCT01383096|P2|Participant Flow|Cohort 2|Subjects received a single of OZ439 800mg PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 2 Fasted, OZ439 800mg Prototype 2 with milk.
803774|NCT01383096|P1|Participant Flow|Cohort 1|Subjects received a single dose of OZ439 800mg PIB Fed, then OZ439 PIB Fasted, then OZ439 800mg with milk, OZ439 800mg Prototype 1 Fasted, OZ439 800mg Prototype 1 with milk.
803775|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
803776|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
803777|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
803778|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
803886|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
803780|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
803781|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
803782|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
803783|NCT01383096|O3|Outcome|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803784|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
803785|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
803786|NCT01383096|O11|Outcome|Cohort 3 - Treatement K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
803787|NCT01383096|O10|Outcome|Cohort 3 - Treatement J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
803788|NCT01383096|O9|Outcome|Cohort 2 - Treatement I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
803789|NCT01383096|O8|Outcome|Cohort 2 - Treatement H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
803790|NCT01383096|O7|Outcome|Cohort 2 - Treatement G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803791|NCT01383096|O6|Outcome|Cohort 2 - Treatement F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
803792|NCT01383096|O5|Outcome|Cohort 1 - Treatement E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
803793|NCT01383096|O4|Outcome|Cohort 1 - Treatement D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
803794|NCT01383096|O3|Outcome|Cohort 1 - Treatment C:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803795|NCT01383096|O2|Outcome|Cohort 1 - Treatement B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
803796|NCT01383096|O1|Outcome|Cohort 1 - Treatement A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
803797|NCT01383096|O11|Outcome|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
803798|NCT01383096|O10|Outcome|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
803799|NCT01383096|O9|Outcome|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
803800|NCT01383096|O8|Outcome|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
803801|NCT01383096|O7|Outcome|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803802|NCT01383096|O6|Outcome|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted
803803|NCT01383096|O5|Outcome|Cohort 1 - Treatment E: OZ439 800mg Prototype F1 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered with milk.
803804|NCT01383096|O4|Outcome|Cohort 1 - Treatment D: OZ439 800 mg Prototype F1 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 1. Administered fasted.
803805|NCT01383096|O3|Outcome|Cohort 1 - Treatment:OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803806|NCT01383096|O2|Outcome|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
803807|NCT01383096|O1|Outcome|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
803808|NCT01383096|E11|Reported Event|Cohort 3 - Treatment K: OZ439 400mg Prototype F1 Fasted|OZ439 400 mg as prototype solution formulation 1. Administered fasted.
803809|NCT01383096|E10|Reported Event|Cohort 3 - Treatment J: OZ439 800mg Prototype F1 Fasted|OZ439 800 mg (as free base) as prototype solution formulation 1. Administered fasted.
803810|NCT01383096|E9|Reported Event|Cohort 2 - Treatment I: OZ349 800mg Prototype F2 With Milk|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered with milk.
803811|NCT01383096|E8|Reported Event|Cohort 2 - Treatment H: OZ439 800 mg Prototype F2 Fasted|OZ439 800 mg (as free base) as a prototype solution formulation 2. Administered fasted.
803812|NCT01383096|E7|Reported Event|Cohort 2 - Treatment G: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803864|NCT01382719|B1|Baseline|Placebo|identical formulation without active ingredient
803865|NCT01382719|P4|Participant Flow|Bremelanotide Arm 3|high dose 1.75 mg BMT
803813|NCT01383096|E6|Reported Event|Cohort 2 - Treatment F: OZ439 800 mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
803816|NCT01383096|E3|Reported Event|Cohort 1 - Treatment C: OZ439 800mg PIB With Milk|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered following 200 mL milk.
803817|NCT01383096|E2|Reported Event|Cohort 1 - Treatment B: OZ439 800mg PIB Fasted|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to oral administration. Administered fasted.
803818|NCT01383096|E1|Reported Event|Cohort 1 - Treatment A: OZ439 800mg PIB Fed|OZ439 800 mg (as free base) as powder in a bottle (PIB) for reconstitution in a suspension prior to administration. Administered 30 minutes after a standard fatty breakfast.
803819|NCT01383005|B3|Baseline|Total|Total of all reporting groups
803820|NCT01383005|B2|Baseline|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
803821|NCT01383005|B1|Baseline|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
803822|NCT01383005|P2|Participant Flow|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
803823|NCT01383005|P1|Participant Flow|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
803824|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803825|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803826|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803827|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803828|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803829|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803830|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
803831|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
803832|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
803833|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
803834|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
803835|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
803892|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
803893|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
803894|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
803836|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803837|NCT01383005|O2|Outcome|Kaletra (LPV/r) QD From Kaletra BID|HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD.
803838|NCT01383005|O1|Outcome|Kaletra (LPV/r) QD as First Kaletra Treatment|HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.
803839|NCT01383005|O1|Outcome|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803840|NCT01383005|E1|Reported Event|Overall Study Population|"HIV-infected participants treated with lopinavir/ritonavir once daily (LPV/r QD) from ≥3 months to <2 years who had not been treated with any of the following: LPV/r twice daily (BID), a protease inhibitor, or a ritonavir-boosted protease inhibitor.~Also, HIV-infected participants treated with LPV/r from ≥3 months to <2 years who had initiated on LPV/r BID and at any time within this period (but at least 3 months before inclusion in the study) had changed dosing from BID to QD."
803841|NCT01382940|B1|Baseline|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803842|NCT01382940|P1|Participant Flow|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803843|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803844|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803845|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803846|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803847|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803848|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803849|NCT01382940|O1|Outcome|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803850|NCT01382940|E1|Reported Event|Rituximab|Rituximab intravenous (IV) infusions were administered over a 4.25-hour period on Day 1, and over a 2-hour period on Day 15 (first course) and on Days 168 and 182 (second course). All participants continued to receive methotrexate as prescribed by their treating physician. Premedication included methylprednisolone, an antihistamine and acetaminophen.
803851|NCT01382901|B3|Baseline|Total|Total of all reporting groups
803852|NCT01382901|B2|Baseline|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
803853|NCT01382901|B1|Baseline|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
803854|NCT01382901|P2|Participant Flow|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
803855|NCT01382901|P1|Participant Flow|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
803856|NCT01382901|O2|Outcome|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
803857|NCT01382901|O1|Outcome|Ferric Carboxymaltose (FCM) 2 x 500 mg|500mg intravenous (IV) dose of FCM on Day 0 and Day 5.
803858|NCT01382901|E2|Reported Event|Placebo|Intravenous (IV) solution of placebo on Day 0 and Day 5.
803888|NCT01382719|O1|Outcome|Placebo|identical formulation without active ingredient
803889|NCT01382719|O4|Outcome|Bremelanotide Arm 3|high dose 1.75 mg BMT
803890|NCT01382719|O3|Outcome|Bremelanotide Arm 2|middle dose 1.25 mg BMT
803898|NCT01382719|E3|Reported Event|Bremelanotide Arm 2|middle dose 1.25 mg BMT
803899|NCT01382719|E2|Reported Event|Bremelanotide Arm 1|low dose 0.75 mg BMT
803900|NCT01382719|E1|Reported Event|Placebo|identical formulation without active ingredient
803901|NCT01382446|B3|Baseline|Total|Total of all reporting groups
803902|NCT01382446|B2|Baseline|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
803903|NCT01382446|B1|Baseline|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
803904|NCT01382446|P2|Participant Flow|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
803905|NCT01382446|P1|Participant Flow|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
803906|NCT01382446|O2|Outcome|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
803907|NCT01382446|O1|Outcome|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
803908|NCT01382446|E2|Reported Event|Chlorhexidine Oral Care Regimen|Chlorhexidine gluconate : 0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
803909|NCT01382446|E1|Reported Event|Standard Oral Care Regimen|Toothpaste : Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
803910|NCT01382303|B3|Baseline|Total|Total of all reporting groups
803911|NCT01382303|B2|Baseline|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803912|NCT01382303|B1|Baseline|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803913|NCT01382303|P2|Participant Flow|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803914|NCT01382303|P1|Participant Flow|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803915|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803916|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803917|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803918|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803919|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803920|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803921|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803922|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803923|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803924|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803925|NCT01382303|O2|Outcome|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803926|NCT01382303|O1|Outcome|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803927|NCT01382303|E2|Reported Event|Placebo|"placebo tablet~Placebo: placebo tablet three times a day"
803928|NCT01382303|E1|Reported Event|Pentoxifylline|"Pentoxifylline 400mg three times a day~Pentoxifylline: Pentoxifylline 400mg three times a day"
803929|NCT01382251|B3|Baseline|Total|Total of all reporting groups
803930|NCT01382251|B2|Baseline|Ambulatory Surgery Caregivers|Caregivers were recruited with the patients receiving surgery
803931|NCT01382251|B1|Baseline|Ambulatory Surgery Patients|Only patients with caregivers were recruited
803932|NCT01382251|P2|Participant Flow|Ambulatory Surgery Caregivers|
803933|NCT01382251|P1|Participant Flow|Ambulatory Surgery Patients|
803934|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
803935|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
803936|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
803937|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
803938|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
803939|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
803940|NCT01382251|O2|Outcome|Ambulatory Surgery Caregivers|
803941|NCT01382251|O1|Outcome|Ambulatory Surgery Patients|
803942|NCT01382251|E1|Reported Event|Ambulatory Surgery Patients|
803943|NCT01382225|B3|Baseline|Total|Total of all reporting groups
803944|NCT01382225|B2|Baseline|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803945|NCT01382225|B1|Baseline|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803946|NCT01382225|P2|Participant Flow|Vehicle|Run-in, followed by Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
805231|NCT01377480|O1|Outcome|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
803947|NCT01382225|P1|Participant Flow|Sodium Hyaluronate|Run-in, followed by Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803948|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803949|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803950|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803951|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803952|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803953|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803954|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803955|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803956|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803957|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803958|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803959|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803960|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803961|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803962|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803963|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803964|NCT01382225|O2|Outcome|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803965|NCT01382225|O1|Outcome|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803966|NCT01382225|E2|Reported Event|Vehicle|Vehicle, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803967|NCT01382225|E1|Reported Event|Sodium Hyaluronate|Sodium Hyaluronate Ophthalmic Solution, 0.18%, 1-2 drops instilled in each eye 3-6 times a day for 14 days
803968|NCT01382212|B1|Baseline|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803969|NCT01382212|P1|Participant Flow|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803970|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803971|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803972|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803973|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803974|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803975|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803976|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803977|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803978|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803979|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803980|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803981|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803982|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803983|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803984|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803985|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803986|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803987|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803988|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803989|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803990|NCT01382212|O1|Outcome|Paricalcitol|Open-label paricalcitol (maximum dose of 16 µg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803991|NCT01382212|E1|Reported Event|Paricalcitol|Open-label paricalcitol (maximum dose of 16 μg), 3 times weekly (no more frequently than every other day) for 12 weeks.
803993|NCT01382186|B2|Baseline|Random Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
803994|NCT01382186|B1|Baseline|Purposive Sampling|Veterans registered for My HealtheVet and opted-in to use Secure Messaging from the Tampa, FL and Boston, MA areas.
803995|NCT01382186|P2|Participant Flow|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
803996|NCT01382186|P1|Participant Flow|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
803997|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
803998|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
803999|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
804000|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
804001|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
804002|NCT01382186|O1|Outcome|Random Sampling|Random sampling was used to conduct a quantitative survey with 819 veterans to explore their experiences using secure messaging.
804003|NCT01382186|O1|Outcome|Purposive Sampling|Purposive sampling was used to identify a sample of 33 Veterans who have been Personally Authenticated for the SM feature on MHV. Participants were recruited from each site (Tampa, Boston). Women were purposively recruited to ensure females were represented in data findings.
804004|NCT01382186|O3|Outcome|Purposive Sampling: Not Able to Complete Task|Veterans in this arm were not able to complete the task.
804005|NCT01382186|O2|Outcome|Purposive Sampling: Able to Complete Task With Difficulty|Veterans in this arm were able to complete task with some difficulty.
804006|NCT01382186|O1|Outcome|Purposive Sampling: Able to Complete Task|Veterans in this arm were able to complete the task.
804007|NCT01382186|E2|Reported Event|Random Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
804008|NCT01382186|E1|Reported Event|Purposive Sampling|Serious and other [non-serious] adverse events were not collected/assessed.
804009|NCT01382108|B3|Baseline|Total|Total of all reporting groups
804010|NCT01382108|B2|Baseline|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
804011|NCT01382108|B1|Baseline|Normal Participants|Participants without meibomian gland dysfunction
804012|NCT01382108|P2|Participant Flow|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
804013|NCT01382108|P1|Participant Flow|Normal Participants|Participants without Meibomian Gland Dysfunction
804014|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
804015|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
804016|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
804017|NCT01382108|O1|Outcome|Normal Participants|Participants without meibomian gland dysfunction
804018|NCT01382108|O2|Outcome|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
804019|NCT01382108|O1|Outcome|Normal Participants|Participants without Meibomian Gland Dysfunction
804020|NCT01382108|E2|Reported Event|Meibomian Gland Dysfunction|Participants with Meibomian Gland Dysfunction
804021|NCT01382108|E1|Reported Event|Normal Participants|Participants without meibomian gland dysfunction
804022|NCT01381952|B1|Baseline|AlluraXper - ClarityIQ|Angiogram with AlluraXper followed by angiogram with ClarityIQ
804023|NCT01381952|P1|Participant Flow|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
804024|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
804025|NCT01381952|O1|Outcome|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
804026|NCT01381952|O2|Outcome|Allura Clarity|Angiogram with AlluraXper followed by angiogram with ClarityIQ
804027|NCT01381952|O1|Outcome|AlluraXper|Angiogram with AlluraXper followed by angiogram with ClarityIQ
804028|NCT01381952|E1|Reported Event|AlluraXper - ClarityIQ|Angiogram with AlluraXper subsequently followed by angiogram with ClarityIQ
804029|NCT01381926|B3|Baseline|Total|Total of all reporting groups
804030|NCT01381926|B2|Baseline|Exenatide 1st Then Placebo|Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
804031|NCT01381926|B1|Baseline|Placebo 1st Then Exenatide|Study participants in period1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
804044|NCT01381900|B2|Baseline|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804045|NCT01381900|B1|Baseline|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804032|NCT01381926|P2|Participant Flow|Placebo 1st Then Exenatide|Study participants in periods1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second periods of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
804049|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804033|NCT01381926|P1|Participant Flow|Exenatide 1st Then Placebo|Study participants in period 1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second period of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
804034|NCT01381926|O2|Outcome|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
804035|NCT01381926|O1|Outcome|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
804036|NCT01381926|O2|Outcome|Placebo Then Exenatide|"Study participants in phase1 will receive the saline placebo, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month study participants will receive Exenatide 5mcg twice daily with meals. During the fifth month, study participants will receive exenatide 10mcg, subcutaneously twice daily before meals.~exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
804037|NCT01381926|O1|Outcome|Exenatide Then Placebo|"Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mg and exenatide 10mg, respectively, subcutaneously twice daily before meals.~exenatide: exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively."
804038|NCT01381926|O2|Outcome|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
804039|NCT01381926|O1|Outcome|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
804040|NCT01381926|E2|Reported Event|Placebo 1st Then Exenatide|Study participants in phase1 will receive the saline placebo at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of saline placebo will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no treatment will be given and this will serve as a “wash out” period prior to the second phase of the study. During the fourth month participants will receive Exenatide 5mcg twice daily before meals. During the fifth month, study participants will get Exenatide 10mcg twice daily before meals.
804041|NCT01381926|E1|Reported Event|Exenatide 1st Then Placebo|Study participants in phase1 will receive the study drug, exenatide, at a dose of 5mcg subcutaneously twice daily 30 minutes before meals for one month. During the second month of the study, the dose of exenatide will be increased to 10mcg subcutaneously twice daily before meals for one month. During the third month of the study, no study medication will be given and this will serve as a “wash out” period prior to the second phase of the study (placebo). During the fourth and fifth months, study participants will get placebo alternatives to exenatide 5mcg and exenatide 10mcg, respectively, subcutaneously twice daily before meals.
804042|NCT01381900|B4|Baseline|Total|Total of all reporting groups
804043|NCT01381900|B3|Baseline|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804046|NCT01381900|P3|Participant Flow|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804047|NCT01381900|P2|Participant Flow|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804048|NCT01381900|P1|Participant Flow|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804165|NCT01381120|E2|Reported Event|Narcotic Painkiller|
804050|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804051|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804052|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804053|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804054|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804055|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804056|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804057|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804058|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804059|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804060|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804061|NCT01381900|O3|Outcome|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804062|NCT01381900|O2|Outcome|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804063|NCT01381900|O1|Outcome|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804064|NCT01381900|E3|Reported Event|Canagliflozin 300 mg|Each participant received 300 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804065|NCT01381900|E2|Reported Event|Canagliflozin 100 mg|Each participant received 100 mg of canagliflozin once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804066|NCT01381900|E1|Reported Event|Placebo|Each participant received matching placebo once daily for 18 weeks with protocol-specified doses of metformin alone or metformin plus sulphonylurea.
804067|NCT01381679|B1|Baseline|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804068|NCT01381679|P1|Participant Flow|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804069|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804070|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804071|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804072|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804073|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804074|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804075|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804076|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804077|NCT01381679|O1|Outcome|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804078|NCT01381679|E1|Reported Event|All Participants|Participants in whom low density lipoprotein cholesterol (LDL-C) target levels have not been achieved and for whom ezetimibe therapy has been chosen.
804079|NCT01381575|B4|Baseline|Total|Total of all reporting groups
804080|NCT01381575|B3|Baseline|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804081|NCT01381575|B2|Baseline|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804082|NCT01381575|B1|Baseline|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804083|NCT01381575|P3|Participant Flow|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804084|NCT01381575|P2|Participant Flow|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804085|NCT01381575|P1|Participant Flow|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804086|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804087|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804088|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804089|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804090|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804091|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804092|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804093|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804094|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804095|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804096|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804097|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804098|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804099|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804100|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804101|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804102|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804103|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804104|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804105|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804270|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804106|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804107|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804108|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804166|NCT01381120|E1|Reported Event|VESIcare + Narcotic Painkiller|
804109|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804110|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804111|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804112|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804113|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804114|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804115|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804116|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804117|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804118|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804119|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804120|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804121|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804122|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804123|NCT01381575|O3|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804124|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804125|NCT01381575|O1|Outcome|Cervarix1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804126|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804127|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804128|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804129|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6, respectively. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804130|NCT01381575|O1|Outcome|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804131|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804132|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804133|NCT01381575|O2|Outcome|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804134|NCT01381575|O1|Outcome|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804135|NCT01381575|E3|Reported Event|Cervarix 3 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 12. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804136|NCT01381575|E2|Reported Event|Cervarix 2 Group|Female subjects aged 15 to 25 years at the time of the first vaccination, who received 3 doses of the Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804137|NCT01381575|E1|Reported Event|Cervarix 1 Group|Female subjects aged 9 to 14 years at the time of the first vaccination, who received 2 doses of the Cervarix vaccine at Months 0 and 6. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
804138|NCT01381471|B1|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
804139|NCT01381471|P1|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
804140|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
804141|NCT01381471|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification [ICD-9] codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one1 pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
804142|NCT01381471|E1|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Participants age 40 or older with at least one pharmacy claim for FSC, at least one medical claim with a primary or secondary diagnosis of Chronic Obstructive Pulmonary Disease (COPD) (International Classification of Disease, 9th Revision [ICD-9], Clinical Modification codes 490.xx, 491.xx, 492.xx, or 496.xx), and at least one pharmacy claim for an anticholinergic medication but no diagnosis for cystic fibrosis (ICD-9 = 277.0x)
804143|NCT01381406|B3|Baseline|Total|Total of all reporting groups
804144|NCT01381406|B2|Baseline|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
804145|NCT01381406|B1|Baseline|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
804146|NCT01381406|P2|Participant Flow|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
804147|NCT01381406|P1|Participant Flow|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period
804148|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
804149|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
804150|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
804151|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
804152|NCT01381406|O2|Outcome|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
804153|NCT01381406|O1|Outcome|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
804154|NCT01381406|E2|Reported Event|TIO Plus FSC/Salmeterol Xinafoate in Combination (TIO + FSC)|Patients receiving TIO plus fluticasone propionate (FSC)/salmeterol xinafoate combination (TIO + FSC) at the time of the index date within the study period
804155|NCT01381406|E1|Reported Event|Tiotropium Bromide (TIO)|Patients receiving tiotropium bromide (TIO) at the index date within the study period.
804156|NCT01381120|B3|Baseline|Total|Total of all reporting groups
804157|NCT01381120|B2|Baseline|Narcotic Painkiller|
804158|NCT01381120|B1|Baseline|VESIcare + Narcotic Painkiller|
804159|NCT01381120|P2|Participant Flow|Narcotic Painkiller|
804160|NCT01381120|P1|Participant Flow|VESIcare + Narcotic Painkiller|
804161|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
804162|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
804163|NCT01381120|O2|Outcome|Narcotic Painkiller|Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
804164|NCT01381120|O1|Outcome|VESIcare + Narcotic Painkiller|VESIcare: Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months Oxycodone and acetaminophen combination treatment: Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
804168|NCT01381016|B2|Baseline|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804169|NCT01381016|B1|Baseline|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804170|NCT01381016|P2|Participant Flow|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804171|NCT01381016|P1|Participant Flow|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804172|NCT01381016|O2|Outcome|Experimental|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804173|NCT01381016|O1|Outcome|Control|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804174|NCT01381016|O2|Outcome|Group 2 - Obese|"Group 2: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804175|NCT01381016|O1|Outcome|Group 1 - Normal Weight|"Group 1: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804176|NCT01381016|E2|Reported Event|Experimental|"Group 2 Experimental: Obese (BMI >30 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804177|NCT01381016|E1|Reported Event|Control|"Group 1 Control: Normal weight (BMI 18-25 kg/m2)~Estradiol, Lutrelef or gonadorelin"
804178|NCT01380834|B3|Baseline|Total|Total of all reporting groups
804179|NCT01380834|B2|Baseline|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
804180|NCT01380834|B1|Baseline|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
804181|NCT01380834|P2|Participant Flow|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
804182|NCT01380834|P1|Participant Flow|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
804183|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
804184|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
804185|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
804186|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
804187|NCT01380834|O2|Outcome|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
804188|NCT01380834|O1|Outcome|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
804189|NCT01380834|E2|Reported Event|Placebo Group|"Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.~control group: Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%."
804190|NCT01380834|E1|Reported Event|Treatment Group|"Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.~treatment group: Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports."
804191|NCT01380782|B3|Baseline|Total|Total of all reporting groups
804192|NCT01380782|B2|Baseline|Arm B Bevacizumab-treated|Bevacizumab-treated participants
804193|NCT01380782|B1|Baseline|Arm A Bevacizumab-naive|Bevacizumab-naive participants
804194|NCT01380782|P4|Participant Flow|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
804989|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804195|NCT01380782|P3|Participant Flow|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
804196|NCT01380782|P2|Participant Flow|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
804197|NCT01380782|P1|Participant Flow|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
804198|NCT01380782|O2|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
804199|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
804200|NCT01380782|O1|Outcome|All Participants (Arm A and B)|
804201|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
804202|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
804203|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
804204|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
804205|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
804206|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
804207|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
804208|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
804209|NCT01380782|O4|Outcome|Arm B (Bevacizumab Treated) - AG|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was anaplastic glioma (AG).
804210|NCT01380782|O3|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
804211|NCT01380782|O2|Outcome|Arm A (Bevacizumab-naive) - AG|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was anaplastic glioma (AG).
804212|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
804213|NCT01380782|O1|Outcome|Arm B (Bevacizumab Treated) - GBM|Participants who had been previously treated with bevacizumab prior to entering the study, and whose currently histology was glioblastoma (GBM).
804214|NCT01380782|O1|Outcome|Arm A (Bevacizumab-naive) - GBM|Participants who had not been treated with bevacizumab prior to entering the study, and whose current histology was glioblastoma (GBM).
804215|NCT01380782|E2|Reported Event|Arm B|Bevacizumab-treated participants
804216|NCT01380782|E1|Reported Event|Arm A|Bevacizumab-naive participants
804217|NCT01380769|B3|Baseline|Total|Total of all reporting groups
804218|NCT01380769|B2|Baseline|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
804219|NCT01380769|B1|Baseline|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
804220|NCT01380769|P2|Participant Flow|BSC (Best Supportive Care) Alone|Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
804221|NCT01380769|P1|Participant Flow|CRLX101 + BSC (Best Supportive Care)|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care (BSC), including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
804222|NCT01380769|O2|Outcome|Best Supportive Care|Best Supportive Care: best supportive care
804223|NCT01380769|O1|Outcome|CRLX101|CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
804224|NCT01380769|O2|Outcome|Best Supportive Care|Best Supportive Care: best supportive care
804225|NCT01380769|O1|Outcome|CRLX101|CRLX101: CRLX101 is administered at 15mg/m2 IV every other week
804271|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804226|NCT01380769|E2|Reported Event|Best Supportive Care (BSC) Only|Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
804227|NCT01380769|E1|Reported Event|CRLX101+BSC|15 mg/m2 CRLX101 infused IV over 60 minutes every other week + Standard therapy consisting of best supportive care, including at least blood and platelet transfusions, therapeutic radiation, and bone marrow support (granulocyte colony-stimulating factor [G-CSF]) as required.
804228|NCT01380730|B9|Baseline|Total|Total of all reporting groups
804229|NCT01380730|B8|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804990|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804230|NCT01380730|B7|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804231|NCT01380730|B6|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804232|NCT01380730|B5|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804233|NCT01380730|B4|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804234|NCT01380730|B3|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804235|NCT01380730|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804236|NCT01380730|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804237|NCT01380730|P8|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804238|NCT01380730|P7|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804239|NCT01380730|P6|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804240|NCT01380730|P5|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804241|NCT01380730|P4|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804242|NCT01380730|P3|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804243|NCT01380730|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804244|NCT01380730|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804245|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804246|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804247|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804248|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804249|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804250|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804251|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804252|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804253|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804254|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804255|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804256|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804257|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804258|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804259|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804260|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804261|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804262|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804263|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804264|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804265|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804266|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804267|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804268|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804269|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804272|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804273|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804274|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804275|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804276|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804277|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804278|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804279|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804280|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804281|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804282|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804283|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804284|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804285|NCT01380730|O8|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804286|NCT01380730|O7|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804287|NCT01380730|O6|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804288|NCT01380730|O5|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804289|NCT01380730|O4|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804290|NCT01380730|O3|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804291|NCT01380730|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804292|NCT01380730|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804293|NCT01380730|E8|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804294|NCT01380730|E7|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804295|NCT01380730|E6|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
804296|NCT01380730|E5|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804297|NCT01380730|E4|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804298|NCT01380730|E3|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
804299|NCT01380730|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
804300|NCT01380730|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
804301|NCT01380639|B3|Baseline|Total|Total of all reporting groups
804302|NCT01380639|B2|Baseline|Rehabilitation Without Vibration Training|
804303|NCT01380639|B1|Baseline|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
804304|NCT01380639|P2|Participant Flow|Rehabilitation Without Vibration Training|
804305|NCT01380639|P1|Participant Flow|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
804306|NCT01380639|O2|Outcome|Rehabilitation Without Vibration Training|
804307|NCT01380639|O1|Outcome|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
804308|NCT01380639|E2|Reported Event|Rehabilitation Without Vibration Training|
804309|NCT01380639|E1|Reported Event|Rehabilitation With Vibration Training|whole body vibration training : performing squats for 3x3 minutes while using vibration platform three times a week
804310|NCT01380379|B1|Baseline|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
804311|NCT01380379|P1|Participant Flow|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
804390|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804980|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804312|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
804391|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804392|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804313|NCT01380379|O1|Outcome|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
804314|NCT01380379|E1|Reported Event|Life Skills and Self-defense Training|"Women will participate in a therapeutic group which covers education, skills, and empowerment activities.~Life skills and self-defense training: 8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing."
804315|NCT01380366|B1|Baseline|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
804316|NCT01380366|P1|Participant Flow|Zorptive Subjects|Patients consent to rHGH and Intestinal Permeability in Intestinal Failure Study
804317|NCT01380366|O1|Outcome|Patient Decreased Liver Injury|Results that show decreased liver injury (ALT, AST, bilirubin, alkaline phosphate (ALK or ALP), GGT) will show Zorbtive administration enhanced intestinal permeability and enhanced liver function.
804318|NCT01380366|O1|Outcome|Patients Experiencing Decrease in Concentration of Sucralose|A decrease in concentration of sucralose in urine indicates Zorbtive potentially enhancing intestinal barrier function.
804319|NCT01380366|E1|Reported Event|Patients Consented to be Given rHGH|Patients given growth hormone (rHGH) for their short bowel syndrome.
804320|NCT01380327|B4|Baseline|Total|Total of all reporting groups
804321|NCT01380327|B3|Baseline|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804322|NCT01380327|B2|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804323|NCT01380327|B1|Baseline|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804324|NCT01380327|P3|Participant Flow|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804325|NCT01380327|P2|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804326|NCT01380327|P1|Participant Flow|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804327|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804328|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804329|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804330|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804433|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804331|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804332|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804333|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804334|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804335|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804336|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804337|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804338|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804339|NCT01380327|O3|Outcome|Placebo|Participants received daily (placebo-low dose) or twice-daily (placebo – high dose) doses of placebo placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804340|NCT01380327|O2|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants received daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804341|NCT01380327|O1|Outcome|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants received twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804342|NCT01380327|E3|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily or twice-daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
804343|NCT01380327|E2|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
804981|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804393|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804394|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804344|NCT01380327|E1|Reported Event|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) twice-daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
804345|NCT01380197|B3|Baseline|Total|Total of all reporting groups
804346|NCT01380197|B2|Baseline|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804347|NCT01380197|B1|Baseline|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804348|NCT01380197|P2|Participant Flow|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804349|NCT01380197|P1|Participant Flow|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804350|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804351|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804352|NCT01380197|O2|Outcome|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804353|NCT01380197|O1|Outcome|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804354|NCT01380197|E2|Reported Event|Randomization to Nubain|"Randomization toNubain or Morphine for the management of Pain Crisis in Sickle Cell patients~Nubain: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804355|NCT01380197|E1|Reported Event|Randomizing Particiipants to Morphine|"Randomizing participants to Morphine or Nubain for treatment of Sickle Cell Pain Crisis~Morphine: Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
804356|NCT01380145|B1|Baseline|All Enrolled Subjects|Includes all subjects enrolled in the study.
804357|NCT01380145|P1|Participant Flow|All Enrolled Subjects|Subjects received a total of 8 pre- and post-auto-SCT immunizations with recMAGE-A3 + AS15 administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.
804358|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
804359|NCT01380145|O1|Outcome|Evaluable Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline disease assessment.
804360|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
804361|NCT01380145|O1|Outcome|Immunogenicity Analysis Set|Includes all subjects who received at least 1 immunization with study drug and had a baseline and at least 1 post-baseline immunity assessment.
804362|NCT01380145|O1|Outcome|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
804363|NCT01380145|E1|Reported Event|Safety Analysis Set|Includes all subjects who received at least 1 immunization with study drug.
804364|NCT01380093|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
804365|NCT01380093|P9|Participant Flow|EMBEDA Then Placebo Then Morphine|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
804366|NCT01380093|P8|Participant Flow|Placebo Then Morphine Then EMBEDA|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
804367|NCT01380093|P7|Participant Flow|Morphine Then EMBEDA Then Placebo|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
804368|NCT01380093|P6|Participant Flow|Morphine Then Placebo Then EMBEDA|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in first intervention period; followed by single dose of matching placebo solution orally in second intervention period; then single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
804369|NCT01380093|P5|Participant Flow|EMBEDA Then Morphine Then Placebo|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in first intervention period; followed by single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in second intervention period; then single dose of matching placebo solution orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
804370|NCT01380093|P4|Participant Flow|Placebo Then EMBEDA Then Morphine|Single dose of matching placebo solution orally in first intervention period; followed by single dose of solution of EMBEDA extended release (ER) capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in second intervention period; then single dose of solution of morphine sulfate (MS Contin) controlled release (CR) tablet 120 mg orally in third intervention period. A washout period of at least 4 days (not exceeding 14 days) was maintained between each intervention period.
804371|NCT01380093|P3|Participant Flow|Placebo Then Morphine|Single dose of matching placebo solution orally on Day 1 followed by single dose of morphine sulfate 120 mg solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
804372|NCT01380093|P2|Participant Flow|Morphine Then Placebo|Single dose of morphine sulfate 120 mg solution orally on Day 1 followed by single dose of matching placebo solution orally on Day 2. Participants in this group were assigned to morphine, placebo and EMBEDA in either of the 6 sequences in the treatment phase of the study.
804373|NCT01380093|P1|Participant Flow|Naloxone|Naloxone hydrochloride 0.2 milligram (mg) intravenously (IV) followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal. Participants in this group were assigned to either morphine then placebo or placebo then morphine in the drug discrimination phase of the study.
804374|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804375|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804376|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804377|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804378|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804379|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804380|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804381|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804382|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804383|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804384|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804385|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804386|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804387|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804388|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804389|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804428|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804395|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804396|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804397|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804398|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804399|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804400|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804401|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804402|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804403|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804404|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804405|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804406|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804407|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804408|NCT01380093|O2|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804409|NCT01380093|O1|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804410|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804411|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804412|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804413|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804414|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804415|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804416|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804417|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804418|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804419|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804420|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804421|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804422|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804423|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804424|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804425|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804426|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804427|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804982|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804429|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804430|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804431|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804432|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804434|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804435|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804436|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804437|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804438|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804439|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804440|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804441|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804442|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804443|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804444|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804445|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804446|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804447|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804448|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804449|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804450|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804451|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804452|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804453|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804454|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804455|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804456|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804457|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804458|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804459|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804460|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804461|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804462|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804463|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804464|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804465|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804466|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804467|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804468|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804469|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804470|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804471|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804472|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804473|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804474|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804475|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804476|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804477|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804478|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804479|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804480|NCT01380093|O2|Outcome|EMBEDA|Single dose of EMBEDA solution containing 120 mg morphine sulfate / 4.8 mg naltrexone hydrochloride administered orally in either of the first to third intervention periods.
804481|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804482|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804483|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804484|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804485|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804486|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804487|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804488|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804489|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804490|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804491|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804492|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804493|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804494|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804495|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804496|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804497|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804498|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804499|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804500|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804501|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804502|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804503|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804504|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804505|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804506|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804507|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804508|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804509|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804510|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804511|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804512|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804513|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804514|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804515|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804516|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804517|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804518|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804519|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804520|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804521|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804522|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804523|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804524|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804525|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804526|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804527|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804528|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804529|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804530|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804531|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804532|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804533|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804534|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804535|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804536|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804537|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804538|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804539|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804540|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804541|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804542|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804543|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804544|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804545|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804546|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804547|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804548|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804549|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804550|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804551|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804552|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804553|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804554|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804555|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804556|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804557|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804558|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804559|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804560|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804561|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804562|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804563|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804564|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804565|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804566|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804567|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804568|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804569|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804570|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804571|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804572|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804573|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804574|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804575|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804576|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804577|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804578|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804579|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804580|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804581|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804582|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804583|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804584|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804585|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804586|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804587|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804588|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804589|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804590|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804591|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804592|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804593|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804594|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804595|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804596|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804597|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804598|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804599|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804600|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804601|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804602|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804603|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804604|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804605|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804606|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804607|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804608|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804609|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804610|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804611|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804612|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804613|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804614|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804615|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804616|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804617|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804618|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804619|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804620|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804621|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804622|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804623|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804624|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804625|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804626|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804627|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804628|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804629|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804630|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804631|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804632|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804633|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804634|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804635|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804636|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804637|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804638|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804639|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804640|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804641|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804642|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804643|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804644|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804645|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804646|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804647|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804648|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804649|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804650|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804651|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804652|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804653|NCT01380093|O3|Outcome|Morphine|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804654|NCT01380093|O2|Outcome|EMBEDA|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804655|NCT01380093|O1|Outcome|Placebo|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804656|NCT01380093|E6|Reported Event|Morphine (Treatment Phase)|Single dose of solution of morphine sulfate (MS Contin) CR tablet 120 mg orally in either of the first to third intervention periods.
804657|NCT01380093|E5|Reported Event|EMBEDA (Treatment Phase)|Single dose of solution of EMBEDA ER capsule containing 120 mg morphine sulfate and 4.8 mg naltrexone hydrochloride orally in either of the first to third intervention periods.
804658|NCT01380093|E4|Reported Event|Placebo (Treatment Phase)|Single dose of matching placebo solution orally in either of the first to third intervention periods.
804659|NCT01380093|E3|Reported Event|Morphine (Drug Discrimination Phase)|Single dose of morphine sulfate 120 mg solution orally on Day 1 or 2.
804660|NCT01380093|E2|Reported Event|Placebo (Drug Discrimination Phase)|Single dose of matching placebo solution orally on Day 1 or 2.
804661|NCT01380093|E1|Reported Event|Naloxone (Naloxone Challenge Phase)|Naloxone hydrochloride 0.2 mg IV followed by additional 0.6 mg naloxone hydrochloride IV, each dose followed by an assessment for signs of withdrawal.
804662|NCT01380080|B3|Baseline|Total|Total of all reporting groups
804983|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804663|NCT01380080|B2|Baseline|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804715|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804664|NCT01380080|B1|Baseline|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804665|NCT01380080|P2|Participant Flow|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804666|NCT01380080|P1|Participant Flow|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804667|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804668|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804669|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804670|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804671|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804672|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804688|NCT01379937|B3|Baseline|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804713|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804673|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804674|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804675|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804676|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804677|NCT01380080|O2|Outcome|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804678|NCT01380080|O1|Outcome|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804679|NCT01380080|E2|Reported Event|Arm B: IPT|Study treatment for Arm B participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral therapy as soon as possible following randomization and within no more than 3 days following randomization and of initiating anti-TB treatment (ATT) only when indicated according to local standard practice and at the discretion of the site investigator. All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only. Pyridoxine is provided by the sites to all participants while they are receiving isoniazid (INH).
804680|NCT01380080|E1|Reported Event|Arm A: Empiric|Study treatment for Arm A participants is the strategy of initiating study-provided or other FDA-approved or tentatively approved antiretroviral treatment as soon as possible following randomization and within no more than 3 days following randomization plus a 4-drug anti-tuberculosis treatment (ATT) regimen (defined as rifampin/isoniazid/ethambutol/pyrazinamide) as soon as possible following randomization and within no more than 7 days following initiation of antiretroviral therapy. After 2 months (or 8 weeks), the 4-drug ATT will be followed with 4 months (or 16 weeks) of 2-drug ATT (defined as rifampin/isoniazid). All participants will be followed through week 96. Drug provision by or through the study will be through week 48 only
804681|NCT01379963|B1|Baseline|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
804682|NCT01379963|P1|Participant Flow|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
804683|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
804684|NCT01379963|O1|Outcome|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
804685|NCT01379963|E1|Reported Event|Methoxy-Polyethylene-Glycol-Epoetin Beta|Participants with renal anemia who were treated with methoxy-polyethylene-glycol-epoetin beta according to the standard clinical practice, were observed for at least 6 months in this retrospective study.
804686|NCT01379937|B5|Baseline|Total|Total of all reporting groups
804687|NCT01379937|B4|Baseline|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
805472|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
804689|NCT01379937|B2|Baseline|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804790|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804690|NCT01379937|B1|Baseline|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804691|NCT01379937|P4|Participant Flow|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804692|NCT01379937|P3|Participant Flow|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804693|NCT01379937|P2|Participant Flow|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804694|NCT01379937|P1|Participant Flow|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804695|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804696|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804697|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804698|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804699|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804700|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804701|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804702|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804703|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804704|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804705|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804706|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804707|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804708|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804709|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804710|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804711|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804712|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
805473|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
804714|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804716|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804717|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804718|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804719|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804720|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804721|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804722|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804723|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804724|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804725|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804726|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804727|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804728|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804729|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804730|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804731|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804732|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804733|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region
804734|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804735|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804736|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804737|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804738|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804789|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804739|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804791|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804740|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804741|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804742|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804743|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804744|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804745|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804746|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804747|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804748|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804749|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804750|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804751|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804752|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804753|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804754|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804755|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804756|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804757|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804758|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804759|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804760|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804761|NCT01379937|O4|Outcome|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804762|NCT01379937|O3|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804763|NCT01379937|O2|Outcome|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804819|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804792|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804991|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804764|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804765|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received no or 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804766|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 & 2 - Havrix/Havrix Jr Pooled Group|Pooled group of subjects who received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, no or 1 booster dose of vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 or 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804767|NCT01379937|O2|Outcome|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804768|NCT01379937|O1|Outcome|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804769|NCT01379937|E4|Reported Event|Havrix / Havrix Jr Group|Subjects in this group received 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804770|NCT01379937|E3|Reported Event|GSK1562902A Formulation 2 - Havrix / Havrix Jr Group|Subjects in this group received 1 dose of Influenza vaccine GSK1562902A Formulation 2 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804771|NCT01379937|E2|Reported Event|GSK1562902A Formulation 1 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1 and 2 doses of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804772|NCT01379937|E1|Reported Event|GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group|Subjects in this group received 2 primary vaccination doses of Influenza vaccine GSK1562902A Formulation 1, a booster vaccination dose of Influenza vaccine GSK1562902A Formulation 2 and 1 dose of Havrix™ or Havrix™ Junior vaccine, administered intramuscularly in the deltoid region.
804773|NCT01379781|B3|Baseline|Total|Total of all reporting groups
804774|NCT01379781|B2|Baseline|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
804775|NCT01379781|B1|Baseline|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
804776|NCT01379781|P2|Participant Flow|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
804777|NCT01379781|P1|Participant Flow|Behavioral Intervention for Postpartum Depression|"Behavioral Intervention for Postpartum Depression delivered over 3 in-person sessions.~Behavioral Intervention for Postpartum Depression: We will select a sample of pregnant women at risk for Postpartum Depression, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
804778|NCT01379781|O2|Outcome|Treatment As Usual|"Referred to Treatment in the Community.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
804779|NCT01379781|O1|Outcome|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
804780|NCT01379781|E2|Reported Event|Treatment As Usual|Referred to Treatment in the Community.
804781|NCT01379781|E1|Reported Event|Behavioral Intervention for PPD|"Behavioral Intervention for PPD delivered over 3 in-person sessions.~Behavioral Intervention for PPD: We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits."
804782|NCT01379768|B4|Baseline|Total|Total of all reporting groups
804783|NCT01379768|B3|Baseline|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804784|NCT01379768|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804785|NCT01379768|B1|Baseline|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804786|NCT01379768|P3|Participant Flow|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804787|NCT01379768|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804788|NCT01379768|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
805474|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
804793|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804794|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804795|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804796|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804797|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804798|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804799|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804800|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804801|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804802|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804803|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804804|NCT01379768|O3|Outcome|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804805|NCT01379768|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804806|NCT01379768|O1|Outcome|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804807|NCT01379768|E3|Reported Event|No Lens Wear|No contact lens wear for the duration of the study. One 8-hour sleep at 1 week, followed by an 8-hour sleep 4 weeks later.
804808|NCT01379768|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon B contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804809|NCT01379768|E1|Reported Event|Lotrafilcon A|Lotrafilcon A contact lenses worn on a daily wear basis for 1 week, followed by 8 hours overnight wear in a replacement pair. After a 12-hour washout period, a new pair of lotrafilcon A contact lenses were dispensed for 4 weeks of daily wear, followed by 8 hours overnight wear.
804810|NCT01379703|B1|Baseline|Total Study Population|HIV-1 infected participants who received lopinavir/ritonavir (any formulation) during any part of the study.
804811|NCT01379703|P3|Participant Flow|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804812|NCT01379703|P2|Participant Flow|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804813|NCT01379703|P1|Participant Flow|Tablets and Capsules or Oral Solution|HIV-1 infected participants who received both tablet and capsule formulations or oral solution.
804814|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804815|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804816|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804817|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804818|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804820|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804821|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804822|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804823|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
805050|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
804824|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804825|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804826|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804827|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804828|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804829|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804830|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804831|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804832|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804833|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804834|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804835|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804836|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804837|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804838|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804839|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804840|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804841|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804842|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804843|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804844|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804845|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804846|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804847|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804848|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804849|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804850|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804851|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804852|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804853|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804854|NCT01379703|O1|Outcome|Capsule Formulation|Participants who received the capsule formulation of lopinavir/ritonavir during Part 1 or Part II of the study.
804855|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804856|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804857|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804858|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804859|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804987|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804860|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804861|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804862|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804863|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804864|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804865|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804866|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804867|NCT01379703|O3|Outcome|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804868|NCT01379703|O2|Outcome|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804869|NCT01379703|O1|Outcome|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804870|NCT01379703|E3|Reported Event|Tablet Formulation|Participants who received the tablet formulation (only) of lopinavir/ritonavir during Parts I or II of the study.
804871|NCT01379703|E2|Reported Event|Capsule Formulation|Participants who received the capsule formulation (only) of lopinavir/ritonavir during Part I or Part II of the study.
804872|NCT01379703|E1|Reported Event|Total Study Population|HIV-1 infected participants who received any formulation of lopinavir/ritonavir during Parts I or II of the study (including 66 participants who received both tablet and capsule formulations, or oral solution).
804873|NCT01379664|B3|Baseline|Total|Total of all reporting groups
804874|NCT01379664|B2|Baseline|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804875|NCT01379664|B1|Baseline|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804876|NCT01379664|P2|Participant Flow|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804877|NCT01379664|P1|Participant Flow|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804878|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804879|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804880|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804881|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804882|NCT01379664|O2|Outcome|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804883|NCT01379664|O1|Outcome|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804884|NCT01379664|E2|Reported Event|Sevoflurane|"Sevoflurane is to be administered to patients in this arm during surgery~Sevoflurane: Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804885|NCT01379664|E1|Reported Event|Isoflurane|"Isoflurane is to be administered to patients in this arm during surgery~Isoflurane: Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist"
804886|NCT01379651|B3|Baseline|Total|Total of all reporting groups
804887|NCT01379651|B2|Baseline|Control|controls were kept on an egg-free diet for 6 months
804888|NCT01379651|B1|Baseline|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
804889|NCT01379651|P2|Participant Flow|Control|controls were kept on an egg-free diet for 6 months
804890|NCT01379651|P1|Participant Flow|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
804891|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
804892|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
804893|NCT01379651|O2|Outcome|Control|controls were kept on an egg-free diet for 6 months
804894|NCT01379651|O1|Outcome|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
804895|NCT01379651|E2|Reported Event|Control|controls were kept on an egg-free diet for 6 months
804896|NCT01379651|E1|Reported Event|Specific Oral Tolerance Induction|Specific oral tolerance induction consisted in the administration of increasing amounts of food antigen
804897|NCT01379625|B3|Baseline|Total|Total of all reporting groups
804898|NCT01379625|B2|Baseline|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804899|NCT01379625|B1|Baseline|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804900|NCT01379625|P2|Participant Flow|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804901|NCT01379625|P1|Participant Flow|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804902|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804903|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804904|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804905|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804906|NCT01379625|O2|Outcome|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804907|NCT01379625|O1|Outcome|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804908|NCT01379625|E2|Reported Event|Triheptanoin|"Subject randomized to consume 20% of energy from triheptanoin.~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804909|NCT01379625|E1|Reported Event|Medium Chain Triglyceride (MCT)|"Subjects randomized to consume 20% of energy from MCT~Triheptanoin: Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone"
804910|NCT01379534|B3|Baseline|Total|Total of all reporting groups
804911|NCT01379534|B2|Baseline|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804912|NCT01379534|B1|Baseline|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804913|NCT01379534|P2|Participant Flow|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804914|NCT01379534|P1|Participant Flow|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804915|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804916|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804917|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804918|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804919|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804920|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804921|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804922|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804923|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804924|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804925|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804926|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804927|NCT01379534|O2|Outcome|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804988|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804928|NCT01379534|O1|Outcome|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804929|NCT01379534|E2|Reported Event|FGFR2 (WT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804930|NCT01379534|E1|Reported Event|FGFR2 (MUT)|Participants were classified into two groups based on mutational status of FGFR2 and all participants were treated with 500 mg of TKI258on a 5 day on / 2 days off dosing regimen for 13 weeks.
804931|NCT01379521|B3|Baseline|Total|Total of all reporting groups
804932|NCT01379521|B2|Baseline|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804933|NCT01379521|B1|Baseline|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804934|NCT01379521|P2|Participant Flow|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804935|NCT01379521|P1|Participant Flow|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804936|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804937|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804938|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804939|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804940|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804941|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804942|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804943|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804944|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804945|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804946|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804947|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804948|NCT01379521|O2|Outcome|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804949|NCT01379521|O1|Outcome|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804950|NCT01379521|E2|Reported Event|Placebo + TACE|Placebo by mouth + transcatheter arterial chemoembolization (TACE)
804951|NCT01379521|E1|Reported Event|Everolimus + TACE|everolimus 7.5mg/day by mouth + transcatheter arterial chemoembolization (TACE)
804952|NCT01379183|B3|Baseline|Total|Total of all reporting groups
804953|NCT01379183|B2|Baseline|Placebo|Matching placebo i.v. suspension
804954|NCT01379183|B1|Baseline|Erythromycin|Erythromycin 200 mg i.v. suspension
804955|NCT01379183|P2|Participant Flow|Placebo|Matching placebo i.v. suspension
804956|NCT01379183|P1|Participant Flow|Erythromycin|Erythromycin 200 mg i.v. suspension
804957|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
804958|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
804959|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
804960|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
804961|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
804962|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
804963|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
804964|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
804965|NCT01379183|O2|Outcome|Placebo|"Matching placebo i.v. suspension~Placebo: 200 mg suspension"
804966|NCT01379183|O1|Outcome|Erythromycin|"Erythromycin 200 mg i.v. suspension~Erythromycin: 200 mg suspension"
804967|NCT01379183|O2|Outcome|Placebo|Matching placebo i.v. suspension
804968|NCT01379183|O1|Outcome|Erythromycin|Erythromycin 200 mg i.v. suspension
804969|NCT01379183|E2|Reported Event|Placebo|Matching placebo i.v. suspension
804970|NCT01379183|E1|Reported Event|Erythromycin|Erythromycin 200 mg i.v. suspension
804971|NCT01378988|B3|Baseline|Total|Total of all reporting groups
804972|NCT01378988|B2|Baseline|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804973|NCT01378988|B1|Baseline|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804974|NCT01378988|P2|Participant Flow|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804975|NCT01378988|P1|Participant Flow|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804976|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804977|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804978|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804979|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
805475|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
804984|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804985|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804986|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804992|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804993|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804994|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804995|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804996|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804997|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
804998|NCT01378988|O2|Outcome|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance infusion
804999|NCT01378988|O1|Outcome|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance infusion
805000|NCT01378988|E2|Reported Event|Dose Level 2|Dexmedetomidine 1.0 mcg/kg loading dose and 0.75 mcg/kg/hr maintenance dose
805001|NCT01378988|E1|Reported Event|Dose Level 1|Dexmedetomidine 0.7 mcg/kg loading dose and 0.5 mcg/kg/hr maintenance dose
805002|NCT01378975|B3|Baseline|Total|Total of all reporting groups
805003|NCT01378975|B2|Baseline|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805004|NCT01378975|B1|Baseline|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805005|NCT01378975|P2|Participant Flow|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805006|NCT01378975|P1|Participant Flow|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805007|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805008|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805009|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805010|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805011|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805046|NCT01378520|P1|Participant Flow|First Ketoconazole, Then Inert Powder|Ketoconzaole (600 mg taken orally) in first intervention period and inert powder (in capsule taken orally) in second intervention period.
805047|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
805048|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
805049|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
805012|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805013|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805014|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805015|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805016|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805017|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805018|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805019|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805020|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805021|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805022|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805139|NCT01378117|E3|Reported Event|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
805023|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805024|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805025|NCT01378975|O1|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805026|NCT01378975|O2|Outcome|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805027|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805028|NCT01378975|O1|Outcome|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805029|NCT01378975|E2|Reported Event|Cohort 2: Previously Treated Participants|Participants who were previously treated with brain SRT, WBRT, or surgery for their brain metastases and have progressed following this treatment, received Vemurafenib 960 milligram (mg) tablet orally, BID from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805030|NCT01378975|E1|Reported Event|Cohort 1: Previously Untreated Participants|Participants who had not received previous treatment for brain metastases [i.e., had never received brain stereotactic radiotherapy (SRT), whole-brain radiotherapy (WBRT), surgery, or any other treatment for their brain metastases] received Vemurafenib 960 milligram (mg) tablet orally, twice daily (BID) from Day 1 until development of progressive disease within the brain or outside of the brain (whichever occurred first), unacceptable toxicity, consent withdrawal, protocol violation endangering participant’s safety, death, reasons deemed by the investigator, or study termination by the Sponsor.
805031|NCT01378962|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805032|NCT01378962|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 milligrams (mg) tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805033|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805034|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805035|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805036|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805037|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805038|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805039|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805040|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805041|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805042|NCT01378962|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805043|NCT01378962|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg tablet orally once daily up to end of study (12 months) or until disease progression, unacceptable toxicity or consent withdrawal.
805044|NCT01378520|B1|Baseline|Entire Study Population|Includes groups randomized to receive Ketoconazole first and inert powder first.
805045|NCT01378520|P2|Participant Flow|First Inert Powder, Then Ketoconazole|Inert powder (in capsule taken orally) in first intervention period and Ketoconzaole (600 mg taken orally) in second intervention period.
805051|NCT01378520|O2|Outcome|Inert Powder|Inert powder (in capsule taken orally)
805052|NCT01378520|O1|Outcome|Ketoconazole|Ketoconazole (600 mg given orally)
805053|NCT01378520|E2|Reported Event|Inert Powder|Inert powder (in capsule taken orally)
805054|NCT01378520|E1|Reported Event|Ketoconazole|Ketoconazole(600 mg taken orally)
805055|NCT01378429|B3|Baseline|Total|Total of all reporting groups
805056|NCT01378429|B2|Baseline|Ciclesonide Nasal Aerosol (74 mcg)|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805057|NCT01378429|B1|Baseline|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805058|NCT01378429|P2|Participant Flow|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
805059|NCT01378429|P1|Participant Flow|Placebo|Placebo: Placebo
805060|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805061|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805062|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
805063|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
805064|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805065|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805066|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805067|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805068|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805069|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805070|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805071|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805072|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805073|NCT01378429|O1|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805074|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
805075|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
805076|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805077|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805078|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805079|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805080|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805081|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805082|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril) for 6 weeks
805083|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril) for 6 weeks
805084|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805085|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805086|NCT01378429|O2|Outcome|Ciclesonide Nasal Aerosol|Ciclesonide nasal aerosol 74 mcg administered once daily (1 actuation of 37 mcg per nostril)
805087|NCT01378429|O1|Outcome|Placebo|Placebo nasal aerosol administered once daily (1 actuation per nostril)
805088|NCT01378429|E2|Reported Event|Ciclesonide Nasal Aerosol|"ciclesonide nasal aerosol (74 mcg)~ciclesonide nasal aerosol: ciclesonide nasal aerosol (74 mcg)"
805089|NCT01378429|E1|Reported Event|Placebo|Placebo: Placebo
805090|NCT01378416|B1|Baseline|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805091|NCT01378416|P1|Participant Flow|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805092|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805093|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805094|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805095|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805096|NCT01378416|O1|Outcome|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805097|NCT01378416|E1|Reported Event|Decitabine|A 15 mg/m^2 dose was administered as a 3-hour IV infusion every 8 hours for 3 consecutive days in acute myelogenous leukemia/myelodysplastic syndrome patients.
805098|NCT01378325|B3|Baseline|Total|Total of all reporting groups
805099|NCT01378325|B2|Baseline|Phenylephrine|PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
805100|NCT01378325|B1|Baseline|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
805101|NCT01378325|P2|Participant Flow|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
805102|NCT01378325|P1|Participant Flow|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
805103|NCT01378325|O2|Outcome|Saline|crystalloid coload with lactated Ringer solution combined with prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
805104|NCT01378325|O1|Outcome|Phenylephrine|"PHenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery~Phenylephrine: Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline"
805105|NCT01378325|E2|Reported Event|Phenylephrine|Phenylephrine infusion started at 0.75 microgram per kg per mL started at spinal injection till delivery
805106|NCT01378325|E1|Reported Event|Saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
805107|NCT01378221|B3|Baseline|Total|Total of all reporting groups
805108|NCT01378221|B2|Baseline|Group 2|cardiac surgery patients aged 75 years and over
805109|NCT01378221|B1|Baseline|Group 1|cardiac surgery patients age 65 years and less
805110|NCT01378221|P2|Participant Flow|Group 2|cardiac surgery patients aged 75 years and over
805111|NCT01378221|P1|Participant Flow|Group 1|cardiac surgery patients age 65 years and less
805112|NCT01378221|O2|Outcome|Group 2|cardiac surgery patients aged 75 years and over
805113|NCT01378221|O1|Outcome|Group 1|cardiac surgery patients age 65 years and less
805114|NCT01378221|E2|Reported Event|Group 2|cardiac surgery patients aged 75 years and over
805115|NCT01378221|E1|Reported Event|Group 1|cardiac surgery patients age 65 years and less
805116|NCT01378195|B3|Baseline|Total|Total of all reporting groups
805117|NCT01378195|B2|Baseline|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
805118|NCT01378195|B1|Baseline|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
805119|NCT01378195|P2|Participant Flow|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
805120|NCT01378195|P1|Participant Flow|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
805121|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
805122|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
805123|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
805124|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
805125|NCT01378195|O2|Outcome|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
805126|NCT01378195|O1|Outcome|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
805127|NCT01378195|E2|Reported Event|Educational/Resources Materials|Educational/Resources Materials: video, workbook, and website.
805128|NCT01378195|E1|Reported Event|CBT-based|CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
805129|NCT01378117|B4|Baseline|Total|Total of all reporting groups
805130|NCT01378117|B3|Baseline|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
805131|NCT01378117|B2|Baseline|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
805132|NCT01378117|B1|Baseline|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
805133|NCT01378117|P3|Participant Flow|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
805134|NCT01378117|P2|Participant Flow|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
805135|NCT01378117|P1|Participant Flow|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
805136|NCT01378117|O3|Outcome|Glargine and Lispro + SSI|Glargine once daily and lispro before meals + acqhs supplemental insulin lispro as needed for elevated blod glucose
805137|NCT01378117|O2|Outcome|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
805138|NCT01378117|O1|Outcome|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
805140|NCT01378117|E2|Reported Event|Sitagliptin and Glargine+ SSI|Sitagliptin 50-100mg po once a day and SQ glargine insulin once daily + acqhs correctional doses of lispro if needed for elevated blood glucose
805141|NCT01378117|E1|Reported Event|Sitagliptin + SSI Prn|Sitagliptin once daily plus supplemental doses of lispro if needed.
805142|NCT01378104|B3|Baseline|Total|Total of all reporting groups
805143|NCT01378104|B2|Baseline|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
805238|NCT01377467|B1|Baseline|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805144|NCT01378104|B1|Baseline|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
805145|NCT01378104|P2|Participant Flow|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
805146|NCT01378104|P1|Participant Flow|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
805147|NCT01378104|O2|Outcome|The Patients With Unfavourable IL28B Genotype|These group patients show the IL28B rs12979860 CT or TT and rs8099917 TG or GG.
805148|NCT01378104|O1|Outcome|Favourable IL28B Genotype|These group patients show the IL28B rs12979860CC and rs8099917TT.
805149|NCT01378104|O2|Outcome|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
805150|NCT01378104|O1|Outcome|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
805151|NCT01378104|E2|Reported Event|80% Dosage Group of Peginterferon Alfa 2a|"This group patients will treated the same full dose (180ug/week) of peginterferon alfa 2a during the first 12 weeks and then reduce the 75% dose (135ug/week) of peginterferon alfa 2a during remnant 36 weeks. At a result, these patients treated with 80% dosage of originally prescribed peginterferon alfa-2a for standard 48 weeks of treatment.~peginterferon alfa 2a (pegasys) : dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable"
805152|NCT01378104|E1|Reported Event|100% Dosage Group of Peginterferon Alfa 2a|"These group patients would be treated with standard dose 180 ug/week for 48 weeks.~peginterferon alfa-2a (pegasys) : These patients would be treated with standard dose 180ug /week for 48 weeks.~In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose."
805153|NCT01378065|B1|Baseline|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805154|NCT01378065|P1|Participant Flow|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805155|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805156|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805157|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805158|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805159|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805160|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805161|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805162|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805192|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
805163|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805164|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805165|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805166|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805167|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805168|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805169|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805170|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805171|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805172|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805173|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805174|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805175|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805176|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805177|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805178|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805179|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805180|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805181|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805182|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805183|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805184|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805185|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805186|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805187|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805188|NCT01378065|O1|Outcome|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805189|NCT01378065|E1|Reported Event|Restorelle Direct Fix|Subjects with clinically significant pelvic organ prolapse of Stage 2 or higher with surgical intervention using Restorelle Direct Fix A & P in the anterior and/or posterior compartment.
805190|NCT01377636|B1|Baseline|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
805191|NCT01377636|P1|Participant Flow|Pre and Post Isoproterenol Infusion|Bispectral EEG (BIS) monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
805230|NCT01377480|O2|Outcome|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
805193|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
805194|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
805195|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
805239|NCT01377467|P2|Participant Flow|Control|No treatment
805196|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
805197|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|Subjects undergoing catheter ablation for atrial fibrillation had measurements pre and post isoproterenol infusion
805198|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
805199|NCT01377636|O1|Outcome|Isoproterenol, BIS, Forearm Test|"30 consecutive patients scheduled for EP studies under general anesthesia will participate in the study. Patients with neuromuscular disease precluding the use of succinylcholine will be excluded. The only other exclusions will be patient or cardiologist refusal. No attempts will be made to alter concurrent patient medication.~Isoproterenol: patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade)."
805200|NCT01377636|O1|Outcome|Pre and Post Isoproterenol Infusion|BIS monitoring and neurological examinations were repeated throughout an isoproterenol infusion protocol (20 minutes maximum) to measure the changes in arousal and ability to follow commands under anesthesia
805201|NCT01377636|E1|Reported Event|Pre and Post Isoproterenol Infusion|In this study, serious adverse events were considered clinically significant adverse events. The well known isoproterenol effects on heart rate, rhythm, ST segments, and blood pressure were noted.
805202|NCT01377623|B3|Baseline|Total|Total of all reporting groups
805203|NCT01377623|B2|Baseline|Dexmedetomidine Group|Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
805204|NCT01377623|B1|Baseline|Placebo Group|Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
805205|NCT01377623|P2|Participant Flow|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
805206|NCT01377623|P1|Participant Flow|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
805207|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
805208|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
805209|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
805210|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
805211|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
805212|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
805213|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
805214|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
805215|NCT01377623|O2|Outcome|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
805216|NCT01377623|O1|Outcome|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
805217|NCT01377623|E2|Reported Event|Placebo Group (PFS)|Anesthesia maintained with propofol/fentanyl/saline
805218|NCT01377623|E1|Reported Event|Dexmedetomidine Group (PFD)|Anesthesia maintained with propofol/fentanyl/dexmedetomidine
805219|NCT01377480|B5|Baseline|Total|Total of all reporting groups
805220|NCT01377480|B4|Baseline|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
805221|NCT01377480|B3|Baseline|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
805222|NCT01377480|B2|Baseline|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
805223|NCT01377480|B1|Baseline|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
805224|NCT01377480|P4|Participant Flow|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
805225|NCT01377480|P3|Participant Flow|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
805226|NCT01377480|P2|Participant Flow|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
805227|NCT01377480|P1|Participant Flow|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
805228|NCT01377480|O4|Outcome|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
805229|NCT01377480|O3|Outcome|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
805232|NCT01377480|E4|Reported Event|Benznidazole + Placebo|BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days and POS placebo (10 mL) oral suspension twice daily for 60 days
805233|NCT01377480|E3|Reported Event|Posaconazole + Benznidazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days and BNZ 100 mg oral tablet twice daily (200-mg daily dose) for 60 days
805234|NCT01377480|E2|Reported Event|Placebo|POS placebo (10 mL) oral suspension twice daily for 60 days
805235|NCT01377480|E1|Reported Event|Posaconazole|POS 400 mg (10 mL) oral suspension twice daily for 60 days
805236|NCT01377467|B3|Baseline|Total|Total of all reporting groups
805237|NCT01377467|B2|Baseline|Control|No treatment
805240|NCT01377467|P1|Participant Flow|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805241|NCT01377467|O2|Outcome|Control|No treatment
805242|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805243|NCT01377467|O2|Outcome|Control|No treatment
805244|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805245|NCT01377467|O2|Outcome|Control|No treatment
805246|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805247|NCT01377467|O2|Outcome|Control|No treatment
805248|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805249|NCT01377467|O2|Outcome|Control|No treatment
805250|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805251|NCT01377467|O2|Outcome|Control|No treatment
805252|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805253|NCT01377467|O2|Outcome|Control|No treatment
805254|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805255|NCT01377467|O2|Outcome|Control|No treatment
805256|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805257|NCT01377467|O2|Outcome|Control|No treatment
805258|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805259|NCT01377467|O2|Outcome|Control|No treatment
805260|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805261|NCT01377467|O2|Outcome|Control|No treatment
805262|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805263|NCT01377467|O2|Outcome|Control|No treatment
805264|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805265|NCT01377467|O2|Outcome|Control|No treatment
805266|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805267|NCT01377467|O2|Outcome|Control|No treatment
805268|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805269|NCT01377467|O2|Outcome|Control|No treatment
805270|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805271|NCT01377467|O2|Outcome|Control|No treatment
805272|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805273|NCT01377467|O2|Outcome|Control|No treatment
805274|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805275|NCT01377467|O2|Outcome|Control|No treatment
805276|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805277|NCT01377467|O2|Outcome|Control|No treatment
805278|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805279|NCT01377467|O2|Outcome|Control|No treatment
805280|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805281|NCT01377467|O2|Outcome|Control|No treatment
805282|NCT01377467|O1|Outcome|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805283|NCT01377467|E2|Reported Event|Control|No treatment
805284|NCT01377467|E1|Reported Event|Denosumab|"60 mg denosumab s.c. at baseline and after 6 months~Denosumab (Prolia): 60 mg s.c. injection at baseline and after 6 months"
805285|NCT01377441|B3|Baseline|Total|Total of all reporting groups
805286|NCT01377441|B2|Baseline|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
805321|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805287|NCT01377441|B1|Baseline|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
805288|NCT01377441|P2|Participant Flow|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
805289|NCT01377441|P1|Participant Flow|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
805290|NCT01377441|O2|Outcome|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
805291|NCT01377441|O1|Outcome|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
805292|NCT01377441|E2|Reported Event|Placebo/Saline Solution|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo~Placebo/Saline solution: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose."
805293|NCT01377441|E1|Reported Event|Ibuprofen|"Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo.~Ibuprofen: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively.~Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose."
805294|NCT01377402|B1|Baseline|Patients With Suspected Acute Coronary Chest Pain|Patients recruited immediately following acute hospital admission for suspected coronary chest pain.
805295|NCT01377402|P1|Participant Flow|Patients With Suspected Acute Coronary Chest Pain|Men and women admitted with chest pain and suspected acute coronary syndrome (ACS).
805296|NCT01377402|O2|Outcome|Myocardial Re-infarction|Patients with one or more myocardial re-infarctions during the course of the study
805297|NCT01377402|O1|Outcome|Cardiovascular Death|Patients with confirmed cardiovascular death during the course of the study
805298|NCT01377402|O1|Outcome|Patients With Suspected ACS|Patients with acute hospitalisation due to suspected coronary chest pain.
805299|NCT01377402|E1|Reported Event|Patients With Suspected ACS|Patients admitted to hospital with acute chest pain.
805300|NCT01377233|B6|Baseline|Total|Total of all reporting groups
805301|NCT01377233|B5|Baseline|Zicronapine 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805302|NCT01377233|B4|Baseline|Zicronapine 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805303|NCT01377233|B3|Baseline|Zicronapine 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805304|NCT01377233|B2|Baseline|Zicronapine 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
805305|NCT01377233|B1|Baseline|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
805306|NCT01377233|P5|Participant Flow|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805307|NCT01377233|P4|Participant Flow|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805308|NCT01377233|P3|Participant Flow|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805309|NCT01377233|P2|Participant Flow|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
805310|NCT01377233|P1|Participant Flow|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
805311|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805312|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805313|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805314|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
805315|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805316|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805317|NCT01377233|O2|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805318|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
805319|NCT01377233|O4|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805320|NCT01377233|O3|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805322|NCT01377233|O1|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
805323|NCT01377233|O5|Outcome|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805324|NCT01377233|O4|Outcome|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805325|NCT01377233|O3|Outcome|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805326|NCT01377233|O2|Outcome|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
805327|NCT01377233|O1|Outcome|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
805328|NCT01377233|E5|Reported Event|Zicronapine High Dose 45 mg Once Weekly|Zicronapine high dose 45 mg once weekly: Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805329|NCT01377233|E4|Reported Event|Zicronapine Med Dose 30 mg Once Weekly|Zicronapine med dose 30 mg once weekly: Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805330|NCT01377233|E3|Reported Event|Zicronapine Low Dose 20 mg Once Weekly|Zicronapine low dose 20 mg once weekly: Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
805331|NCT01377233|E2|Reported Event|Zicronapine Basis Dose 10 mg Daily|Zicronapine basis dose 10 mg daily: Encapsulated tablet, 10 mg, once daily, double-blind
805332|NCT01377233|E1|Reported Event|Zicronapine Open-label 10 mg Daily|Zicronapine open-label 10 mg daily: Encapsulated tablet ,10 mg, once daily, open-label
805333|NCT01377194|B4|Baseline|Total|Total of all reporting groups
805334|NCT01377194|B3|Baseline|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
805335|NCT01377194|B2|Baseline|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
805336|NCT01377194|B1|Baseline|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
805337|NCT01377194|P3|Participant Flow|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
805338|NCT01377194|P2|Participant Flow|Levomilnacipran ER 40 mg|40mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
805339|NCT01377194|P1|Participant Flow|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
805340|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
805341|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily, for 8 weeks
805342|NCT01377194|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
805343|NCT01377194|O3|Outcome|Levomilnacipran ER 80 mg|80mg of Levomilnacipran ER oral administration in capsule form, once daily for 8 weeks
805344|NCT01377194|O2|Outcome|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER oral administration in capsule form, once daily, for 8 weeks.
805345|NCT01377194|O1|Outcome|Placebo|Dose matched placebo oral administration in capsule form, once daily, for 8 weeks.
805346|NCT01377194|E3|Reported Event|Levomilnacipran 80 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
805347|NCT01377194|E2|Reported Event|Levomilnacipran ER 40 mg|40mg Levomilnacipran ER, oral administration in capsule form, once daily for 8 weeks.
805348|NCT01377194|E1|Reported Event|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks.
805349|NCT01377012|B4|Baseline|Total|Total of all reporting groups
805350|NCT01377012|B3|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805351|NCT01377012|B2|Baseline|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805352|NCT01377012|B1|Baseline|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805353|NCT01377012|P3|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805354|NCT01377012|P2|Participant Flow|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805355|NCT01377012|P1|Participant Flow|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks up to Week 100, then AIN457 150 mg s.c. starting at week 104
805356|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805357|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805358|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805359|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805360|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805361|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805362|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805363|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805364|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805365|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805486|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805366|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805367|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805368|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805369|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805370|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805371|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805372|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805373|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805374|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805375|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805376|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805377|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805378|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805379|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805380|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805381|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805382|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805383|NCT01377012|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24
805384|NCT01377012|O2|Outcome|AIN457 10mg/Kg-150mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks
805385|NCT01377012|O1|Outcome|AIN457 10mg/Kg-75mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks
805386|NCT01377012|E3|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16 of core. Responders were switched to active treatment in week 24 of core
805387|NCT01377012|E2|Reported Event|Any AIN457 150 mg|Group contains all patients from the core and the extension that ever received AIN 150mg. This includes : participants who were randomized to AIN457 150 mg arm to receive AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 150 mg at week 16 or week 24 + participants who completed core study in any arm and continued in the extension study to receive AIN457 150 mg as open-label study drug
805388|NCT01377012|E1|Reported Event|Any AIN457 75 mg|Group contains all patients who received AIN 75mg during core period of the study. Includes : participants who were randomized to receive AIN457 i.v (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 injected every 4 weeks + participants who were re-randomized to switch from placebo to AIN457 75 mg at week 16 or week 24 of core study
805389|NCT01376908|B3|Baseline|Total|Total of all reporting groups
805390|NCT01376908|B2|Baseline|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805469|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805391|NCT01376908|B1|Baseline|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805392|NCT01376908|P2|Participant Flow|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805405|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria. After 26 weeks, the starting dose of Kuvan will be 10 mg/kg/day, and the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
805393|NCT01376908|P1|Participant Flow|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805394|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805395|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805396|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805397|NCT01376908|O3|Outcome|Population PK Analysis Set: Age Group 2 (>= 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805398|NCT01376908|O2|Outcome|Population PK Analysis Set: Age Group 2 (1 to 2 Years)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805399|NCT01376908|O1|Outcome|Population PK Analysis Set: Age Group 1 (< 1 Year)|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805400|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject’s Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805401|NCT01376908|O1|Outcome|Population PK Analysis Set|All enrolled subjects for whom at least one adequately documented BH4 concentration value and dose record were included in the population PK analysis. This includes patients receiving either Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day) in conjunction with a Phe-restricted diet, or diet alone. If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the Kuvan® dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805402|NCT01376908|O1|Outcome|Pharmacogenetic Evaluation|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805403|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805404|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805406|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.After 26 weeks, the dose may be adjusted by the Investigator, if clinically indicated, but it may not exceed 20 mg/kg/day.
805407|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805408|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805409|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805410|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805411|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805412|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805413|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805414|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805415|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805416|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805417|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805418|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805419|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805420|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805421|NCT01376908|O2|Outcome|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805422|NCT01376908|O1|Outcome|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805470|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805423|NCT01376908|E2|Reported Event|Phe-restricted Diet|Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805424|NCT01376908|E1|Reported Event|Kuvan® + Phe-restricted Diet|Kuvan® (sapropterin dihydrochloride) tablets were administered orally at a dose of 10 milligram/kilogram/day (mg/kg/day). If after 4 weeks, there was less than 20 percent (%) increase in subject's Phe tolerance versus baseline, the dose was escalated to 20 mg/kg/day. Phenylalanine (Phe)-restricted diet was adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
805425|NCT01376804|B1|Baseline|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805482|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805426|NCT01376804|P1|Participant Flow|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose [in milligrams (mg)] was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805427|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805428|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805429|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805430|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805431|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805432|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805433|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805434|NCT01376804|O1|Outcome|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805435|NCT01376804|E1|Reported Event|Valganciclovir|Participants received a once daily oral dose (solution or tablets) of valganciclovir starting within 10 days of kidney transplant for up to 200 days post-transplant. Dose (in mg) was calculated using the algorithm [7 * Body Surface Area * Creatinine Clearance].
805436|NCT01376700|B1|Baseline|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
805437|NCT01376700|P1|Participant Flow|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
805438|NCT01376700|O2|Outcome|MTPs|≤4 previous FVIII exposures
805439|NCT01376700|O1|Outcome|PUPs|No previous FVIII exposure
805440|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.
805441|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805442|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805443|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805471|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805444|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805483|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
805484|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805485|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805445|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805446|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805447|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805448|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805449|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805450|NCT01376700|O1|Outcome|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805451|NCT01376700|E1|Reported Event|ADVATE - Prophylactic Regimen|"Weekly infusions of ADVATE. Study visits (physical examination, lab tests including FVIII inhibitor tests) every week during the first 10 exposure days (EDs), every 5 weeks during the next 10 EDs and every 10 weeks thereafter.~Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM): Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose."
805452|NCT01376557|B6|Baseline|Total|Total of all reporting groups
805453|NCT01376557|B5|Baseline|Placebo qd|Placebo: Subjects will receive placebo once daily.
805454|NCT01376557|B4|Baseline|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805455|NCT01376557|B3|Baseline|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805456|NCT01376557|B2|Baseline|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805457|NCT01376557|B1|Baseline|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805458|NCT01376557|P5|Participant Flow|Placebo qd|Placebo: Subjects will receive placebo once daily.
805459|NCT01376557|P4|Participant Flow|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805460|NCT01376557|P3|Participant Flow|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805461|NCT01376557|P2|Participant Flow|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805462|NCT01376557|P1|Participant Flow|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805463|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
805464|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805465|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805466|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805467|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805468|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
805476|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805477|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805478|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
805479|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805480|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805481|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805487|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805488|NCT01376557|O5|Outcome|Placebo qd|Placebo: Subjects will receive placebo once daily.
805489|NCT01376557|O4|Outcome|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805490|NCT01376557|O3|Outcome|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805491|NCT01376557|O2|Outcome|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805492|NCT01376557|O1|Outcome|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805493|NCT01376557|E5|Reported Event|Placebo qd|Placebo: Subjects will receive placebo once daily.
805494|NCT01376557|E4|Reported Event|200 mg LX4211 Bid|Subjects will receive 200 mg LX4211 twice daily.
805495|NCT01376557|E3|Reported Event|400 mg LX4211 qd|Subjects will receive 400 mg LX4211 once daily.
805496|NCT01376557|E2|Reported Event|200 mg LX4211 qd|Subjects will receive 200 mg LX4211 once daily.
805497|NCT01376557|E1|Reported Event|75 mg LX4211 qd|Subjects will receive 75 mg LX4211 once daily
805498|NCT01376388|B1|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805499|NCT01376388|P1|Participant Flow|UMEC/VI 125/25 µg|Participants received GSK573719/GW642444 (UMEC/VI) 125/25 micrograms (µg) inhalation powder via a dry powder inhaler (DPI) once daily (OD) in the morning for 52 weeks.
805500|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805501|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805502|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805503|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805504|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805505|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805506|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805507|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805508|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805509|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805510|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805511|NCT01376388|O1|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg inhalation powder via a DPI OD in the morning for 52 weeks.
805512|NCT01376388|E1|Reported Event|GSK573719/GW642444|125/25mcg
805513|NCT01376362|B1|Baseline|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805514|NCT01376362|P1|Participant Flow|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805515|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805516|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805517|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805622|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805518|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805519|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805538|NCT01376297|O2|Outcome|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
805520|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805521|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805522|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805523|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805524|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805525|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805526|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805527|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805528|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805529|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805530|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805531|NCT01376362|O1|Outcome|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805532|NCT01376362|E1|Reported Event|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
805533|NCT01376297|B3|Baseline|Total|Total of all reporting groups
805534|NCT01376297|B2|Baseline|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
805623|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805535|NCT01376297|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
805536|NCT01376297|P2|Participant Flow|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
805537|NCT01376297|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
805539|NCT01376297|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
805540|NCT01376297|E2|Reported Event|Aprepitant and Palonosetron Plus Dexamethasone|"Oral aprepitant hard capsule 125 mg (on Day 1) + 80 mg daily (for the following two days) and oral palonosetron soft capsule 0.50 mg (on Day 1) given with oral dexamethasone at each scheduled chemotherapy cycle.~Aprepitant~Palonosetron~Dexamethasone"
805541|NCT01376297|E1|Reported Event|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule (on Day 1) with oral dexamethasone prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
805542|NCT01376245|B5|Baseline|Total|Total of all reporting groups
805543|NCT01376245|B4|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805544|NCT01376245|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805545|NCT01376245|B2|Baseline|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805546|NCT01376245|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
805547|NCT01376245|P5|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805548|NCT01376245|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805549|NCT01376245|P3|Participant Flow|FF /VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805550|NCT01376245|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
805551|NCT01376245|P1|Participant Flow|Placebo- Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
805552|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805553|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805554|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805555|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
805556|NCT01376245|O4|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805557|NCT01376245|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805558|NCT01376245|O2|Outcome|FF/VI 50/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805559|NCT01376245|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
805560|NCT01376245|E4|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805624|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805561|NCT01376245|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805562|NCT01376245|E2|Reported Event|FF/VI 50/25 µg OD|articipants received Fluticasone Furoate (FF)/Vilanterol (VI) 50/25 micrograms (µg) OD in the morning over the 24-week treatment period. In addition, participants were provided albuterol/salbutamol (MDI or nebules) to be used as needed throughout the study.
805563|NCT01376245|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning for 24 weeks. In addition, participants were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] or nebules) to be used as needed throughout the study.
805564|NCT01376089|B3|Baseline|Total|Total of all reporting groups
805565|NCT01376089|B2|Baseline|Arm 2-Iopamidol|
805566|NCT01376089|B1|Baseline|Arm 1-Iodixanol|
805567|NCT01376089|P2|Participant Flow|Arm 2-Iopamidol|Subjects were injected with Iopamidol (Isovue).
805568|NCT01376089|P1|Participant Flow|Arm 1-Iodixanol|Subjects were injected with Iodixanol (Visipaque).
805569|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
805570|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
805571|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subjects injected with Isovue 370mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
805572|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media. Number of subjects with any Moderate / Severe discomfort.
805573|NCT01376089|O2|Outcome|Arm 2-Iopamidol (Isovue)|Subjects injected with Isovue contrast media. Number of subjects with any Moderate / Severe discomfort.
805574|NCT01376089|O1|Outcome|Arm 1-Iodixanol (Visipaque)|Subjects injected with Visipaque contrast media. Number of subjects with any Moderate / Severe discomfort.
805575|NCT01376089|E2|Reported Event|Arm 2-Iopamidol (Isovue 370mgI/mL)|Subject injected with Isovue 370mgI/mL contrast media.
805576|NCT01376089|E1|Reported Event|Arm 1-Iodixanol (Visipaque 320mgI/mL)|Subjects injected with Visipaque 320mgI/mL contrast media.
805577|NCT01376050|B3|Baseline|Total|Total of all reporting groups
805578|NCT01376050|B2|Baseline|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
805579|NCT01376050|B1|Baseline|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
805580|NCT01376050|P2|Participant Flow|Placebo Laser|Placebo Laser has the same appearance and function as the Erchonia MLS but not does emit any therapeutic output.
805581|NCT01376050|P1|Participant Flow|Erchonia ML Scanner (MLS)|Erchonia ML Scanner (MLS) comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light-emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
805582|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
805583|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
805584|NCT01376050|O2|Outcome|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
805585|NCT01376050|O1|Outcome|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
805586|NCT01376050|E2|Reported Event|Placebo Laser|Placebo Laser has the same appearance and application as the Erchonia MLS but does not emit an therapeutic output.
805587|NCT01376050|E1|Reported Event|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 milliWatts (mW) 635 nanometer (nm) light emitting diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center, and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
805588|NCT01376037|B3|Baseline|Total|Total of all reporting groups
805589|NCT01376037|B2|Baseline|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
805590|NCT01376037|B1|Baseline|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
805591|NCT01376037|P2|Participant Flow|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
805625|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
806990|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
805592|NCT01376037|P1|Participant Flow|Erchonia ML Scanner (MLS)|The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17 milliWatts (mW) 635nm red laser light. The diodes are mounted in scanner devices positioned 120 degrees tileted from each other at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.
805593|NCT01376037|O2|Outcome|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
805633|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805594|NCT01376037|O1|Outcome|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
805595|NCT01376037|E2|Reported Event|Inactive Placebo Laser Device|"The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output.~inactive placebo laser device : The inactive placebo laser device looks identical to the active laser device, but does not emit any therapeutic light output."
805596|NCT01376037|E1|Reported Event|Erchonia ML Scanner (MLS)|"The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm ed laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is activated for 20 minutes per arm during which time the 4 rotating diodes create a spiraling circle pattern that is totally random and independent from the others. These patterns overlap each other to guarantee total coverage within the target area. The total laser energy the test subject is exposed to per treated arm is approximately 3.94 joules per square centimeter.~Erchonia(r) ML Scanner (MLS) : The Erchonia ML Scanner (MLS) is a low level laser light therapy device comprising 4 independent rotating diodes, each emitting 17mW 635nm of red laser light. The diodes are mounted in scanner devices positioned 120 degrees apart from each other, tilted at a 30 degree angle. The Erchonia® MLS is a"
805597|NCT01375777|B10|Baseline|Total|Total of all reporting groups
805598|NCT01375777|B9|Baseline|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805599|NCT01375777|B8|Baseline|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805600|NCT01375777|B7|Baseline|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805601|NCT01375777|B6|Baseline|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805602|NCT01375777|B5|Baseline|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805603|NCT01375777|B4|Baseline|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805604|NCT01375777|B3|Baseline|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805605|NCT01375777|B2|Baseline|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805606|NCT01375777|B1|Baseline|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805607|NCT01375777|P9|Participant Flow|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805608|NCT01375777|P8|Participant Flow|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805609|NCT01375777|P7|Participant Flow|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805610|NCT01375777|P6|Participant Flow|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805611|NCT01375777|P5|Participant Flow|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805612|NCT01375777|P4|Participant Flow|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805613|NCT01375777|P3|Participant Flow|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805614|NCT01375777|P2|Participant Flow|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805615|NCT01375777|P1|Participant Flow|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805616|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805617|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805618|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805619|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805620|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805621|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805626|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805627|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805628|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805629|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805630|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805631|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805632|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805634|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805635|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805636|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805637|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805638|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805639|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805640|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805641|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805642|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805643|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805644|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805645|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805646|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805647|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805648|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805649|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805650|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805651|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805652|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805653|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805654|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805655|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805656|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805657|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805658|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805659|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805660|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805661|NCT01375777|O9|Outcome|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805662|NCT01375777|O8|Outcome|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805663|NCT01375777|O7|Outcome|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805664|NCT01375777|O6|Outcome|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805665|NCT01375777|O5|Outcome|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805666|NCT01375777|O4|Outcome|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805667|NCT01375777|O3|Outcome|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805668|NCT01375777|O2|Outcome|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805669|NCT01375777|O1|Outcome|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805670|NCT01375777|E9|Reported Event|Evolocumab 420 mg Q4W|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805671|NCT01375777|E8|Reported Event|Evolocumab 350 mg Q4W|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805672|NCT01375777|E7|Reported Event|Evolocumab 280 mg Q4W|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805673|NCT01375777|E6|Reported Event|Evolocumab 140 mg Q2W|Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805674|NCT01375777|E5|Reported Event|Evolocumab 105 mg Q2W|Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805675|NCT01375777|E4|Reported Event|Evolocumab 70 mg Q2W|Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks.
805676|NCT01375777|E3|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe orally once a day for 12 weeks.
805677|NCT01375777|E2|Reported Event|Placebo Q4W|Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks.
805678|NCT01375777|E1|Reported Event|Placebo Q2W|Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks.
805679|NCT01375764|B6|Baseline|Total|Total of all reporting groups
805680|NCT01375764|B5|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805681|NCT01375764|B4|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805682|NCT01375764|B3|Baseline|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805683|NCT01375764|B2|Baseline|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805684|NCT01375764|B1|Baseline|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805685|NCT01375764|P5|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805686|NCT01375764|P4|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805687|NCT01375764|P3|Participant Flow|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805688|NCT01375764|P2|Participant Flow|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805689|NCT01375764|P1|Participant Flow|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805690|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805691|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805692|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805693|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805694|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805695|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805696|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805697|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805698|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805699|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805700|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805701|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805702|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805703|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805704|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805705|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805706|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805707|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805708|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805709|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805710|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805711|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805712|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805713|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805714|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805715|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
806991|NCT01370655|E4|Reported Event|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
805716|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805717|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805718|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805719|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805720|NCT01375764|O2|Outcome|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805721|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805722|NCT01375764|O4|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805723|NCT01375764|O3|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805724|NCT01375764|O2|Outcome|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805725|NCT01375764|O1|Outcome|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805726|NCT01375764|E5|Reported Event|Evolocumab + Ezetimibe|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805727|NCT01375764|E4|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805728|NCT01375764|E3|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805729|NCT01375764|E2|Reported Event|Evolocumab 280 mg|Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805730|NCT01375764|E1|Reported Event|Ezetimibe|Participants received placebo subcutaneous injection once every 4 weeks and 10 mg ezetimibe orally once a day for 12 weeks.
805731|NCT01375751|B4|Baseline|Total|Total of all reporting groups
805732|NCT01375751|B3|Baseline|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805733|NCT01375751|B2|Baseline|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805734|NCT01375751|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805735|NCT01375751|P3|Participant Flow|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805736|NCT01375751|P2|Participant Flow|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805737|NCT01375751|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805738|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805739|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805740|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805741|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805742|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805743|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805744|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805745|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805746|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805747|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805748|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805749|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805750|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805751|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805752|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805753|NCT01375751|O3|Outcome|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805754|NCT01375751|O2|Outcome|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805755|NCT01375751|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805756|NCT01375751|E3|Reported Event|Evolocumab 420 mg|Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805757|NCT01375751|E2|Reported Event|Evolocumab 350 mg|Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
805758|NCT01375751|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection once every 4 weeks for 12 weeks.
805759|NCT01375660|B3|Baseline|Total|Total of all reporting groups
805760|NCT01375660|B2|Baseline|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805761|NCT01375660|B1|Baseline|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805762|NCT01375660|P2|Participant Flow|50K Vitamin D2|supplement of vitamin D 400 units provided to all subjects in addition to 50K vitamin D2.
806992|NCT01370655|E3|Reported Event|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
805763|NCT01375660|P1|Participant Flow|Placebo|supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805764|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805765|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805766|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805767|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805768|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805769|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805770|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805771|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805772|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805773|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805774|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805775|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
805776|NCT01375660|O2|Outcome|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition to D2 50K.
805777|NCT01375660|O1|Outcome|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to Placebo.
805778|NCT01375660|E2|Reported Event|50K Vitamin D2|Supplement of vitamin D 400 units provided to all subjects in addition get to D2 50K.
805779|NCT01375660|E1|Reported Event|Placebo|Supplement of vitamin D 400 units provided to all subjects in addition to placebo.
805780|NCT01375608|B1|Baseline|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
805781|NCT01375608|P1|Participant Flow|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
805782|NCT01375608|O1|Outcome|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
805783|NCT01375608|E1|Reported Event|Subcutaneous Decitabine in Sickle Cell Disease|decitabine (starting dose of 0.20 mg/kg, 2 days per week) to induce fetal hemoglobin (HbF) in patients with sickle cell anemia who are refractory to or intolerant of hydroxyurea
805784|NCT01375569|B1|Baseline|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
805785|NCT01375569|P1|Participant Flow|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
805786|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
805787|NCT01375569|O1|Outcome|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
805788|NCT01375569|E1|Reported Event|TRC105 in Liver Cancer|TRC105 is an experimental cancer drug designed to slow or stop the growth of tumors. It does this by preventing the growth of new blood vessels that feed these tumors. This drug is being used to test the safety and effectiveness to treat liver cancer that has not responded to standard therapy. TRC105 will be given as an intravenous infusion every two weeks.
805789|NCT01375374|B1|Baseline|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
805790|NCT01375374|P1|Participant Flow|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
805791|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
805868|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
805792|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
805793|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
806212|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
805794|NCT01375374|O1|Outcome|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
805795|NCT01375374|E1|Reported Event|Lacosamide|"commercial 50 mg (pinkish) and 100 mg (yellow) tablets~Lacosamide: 4-week Titration Period: start dose Lacosamide (LCM) was 100 mg/day - up-titration of 100 mg/week LCM.~8-week Maintenance Period: dose could change first 4 weeks with 100 mg/week, needed to remain between 300 mg/day and 600 mg/day. Dose needed to remain stable last 4 weeks.~Levetiracetam: Levetiracetam (LEV) was taken at a stable dose 30 days before study entry and was ≥ 1000 mg/day at the first visit. The LEV dose could not be changed at any time."
805796|NCT01375127|B7|Baseline|Total|Total of all reporting groups
805797|NCT01375127|B6|Baseline|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805798|NCT01375127|B5|Baseline|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805799|NCT01375127|B4|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805800|NCT01375127|B3|Baseline|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805801|NCT01375127|B2|Baseline|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805802|NCT01375127|B1|Baseline|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
805803|NCT01375127|P6|Participant Flow|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805804|NCT01375127|P5|Participant Flow|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805805|NCT01375127|P4|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805806|NCT01375127|P3|Participant Flow|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805807|NCT01375127|P2|Participant Flow|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805808|NCT01375127|P1|Participant Flow|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
805809|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805810|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
806993|NCT01370655|E2|Reported Event|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
805811|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805812|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805813|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805814|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
805815|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805816|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805817|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805818|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805819|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805820|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
805821|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805822|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805823|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805824|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805825|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805826|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
805827|NCT01375127|O6|Outcome|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805828|NCT01375127|O5|Outcome|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805829|NCT01375127|O4|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805830|NCT01375127|O3|Outcome|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805869|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
805831|NCT01375127|O2|Outcome|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805832|NCT01375127|O1|Outcome|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
805833|NCT01375127|E6|Reported Event|Tofacitinib 30 mg (Study A3921009)|Participants who received tofacitinib 30 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805834|NCT01375127|E5|Reported Event|Tofacitinib 15 mg (Study A3921009)|Participants who received tofacitinib 15 mg tablet orally twice daily up to Month 6 during study A3921009 (NCT00106639) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805835|NCT01375127|E4|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 3)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 3 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805836|NCT01375127|E3|Reported Event|Tofacitinib 15 mg (Study A3921030, Month 1 to 6)|Participants who received tofacitinib 15 mg tablet orally twice daily for Month 1 to 6 during study A3921030 (NCT00483756) were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805837|NCT01375127|E2|Reported Event|Tofacitinib 15 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 15 mg tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of PTLD, CNS infection, graft failure and death (if any).
805838|NCT01375127|E1|Reported Event|Tofacitinib 10 mg (Pre-amendment 1, Study A3921030)|Participants who received tofacitinib 10 milligram (mg) tablet orally twice daily during study A3921030 (NCT00483756) pre-amendment 1 were followed-up through 12 months after the last dose of tofacitinib to evaluate occurrence of post-transplant lymphoproliferative disease (PTLD), central nervous system (CNS) infection, graft failure and death (if any).
805839|NCT01375049|B1|Baseline|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805840|NCT01375049|P1|Participant Flow|AZLI|Participants received one 28-day course of Aztreonam for Inhalation Solution (AZLI), then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805841|NCT01375049|O1|Outcome|AZLI - Sensitivity Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Sensitivity Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a PA-positive culture from Day 28 through Day 196 or used any additional antipseudomonal antibiotics from Day 28 through Day 196."
805842|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805843|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805844|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805845|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805846|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805847|NCT01375049|O1|Outcome|AZLI|Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.
805848|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
805849|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
805850|NCT01375049|O2|Outcome|AZLI - Did Not Meet Primary Efficacy Endpoint|"This group included participants who did not meet the primary efficacy endpoint, defined as having any PA-positive culture at Day 28 through Day 196 or having used anti-PA antibiotics through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
805851|NCT01375049|O1|Outcome|AZLI - Met Primary Efficacy Endpoint|"This group included participants who met the primary efficacy endpoint, defined as having PA-negative cultures at all time points after cessation of active treatment through Day 196.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
805852|NCT01375049|O1|Outcome|AZLI - Evaluable Analysis Set|"Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer.~The Evaluable Analysis Set consists of participants who completed study drug and did not receive an additional antipseudomonal antibiotic during the 28-day AZLI treatment course, and either completed the study through Day 196 with PA-negative cultures at every visit without the use of additional antipseudomonal antibiotics from Day 28 through Day 196 or had evidence of a positive PA-positive culture from Day 28 through Day 196."
805853|NCT01375049|E1|Reported Event|AZLI|"Treatment-emergent adverse events and treatment-emergent serious adverse events were collected from Baseline through Day 28 plus 30 days.~Participants received one 28-day course of AZLI, then were followed for a 24-week period (through Day 196). AZLI 75 mg was administered 3 times daily via the investigational eFlow® nebulizer."
805854|NCT01374971|B1|Baseline|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
805855|NCT01374971|P1|Participant Flow|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-Tumor Necrosis Factor (TNF), humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
805856|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
805857|NCT01374971|O1|Outcome|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
805858|NCT01374971|E1|Reported Event|Certolizumab Pegol (CZP)|"Certolizumab Pegol (CZP) liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Certolizumab Pegol (CZP): CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.~Arthroscopic synovial tissue biopsy: Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver."
805859|NCT01374919|B1|Baseline|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
805860|NCT01374919|P1|Participant Flow|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
805861|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
805862|NCT01374919|O1|Outcome|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
805863|NCT01374919|E1|Reported Event|Total Dose 1020 mg Feramoxytol|All participants receive 1020 mg of Feramoxytol.
805864|NCT01374802|B1|Baseline|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: faldaprevir together with DRV/r."
805865|NCT01374802|P1|Participant Flow|All Subjects|"The study was performed as an open-label, multiple-dose, single-group, fixed-sequence study in 14 healthy volunteers.~Period 1: Darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r).~Period 2: Faldaprevir together with DRV/r."
805866|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
805867|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
806994|NCT01370655|E1|Reported Event|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
805870|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
805871|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
805872|NCT01374802|O2|Outcome|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
805873|NCT01374802|O1|Outcome|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r) once daily
805874|NCT01374802|E2|Reported Event|Faldaprevir+Darunavir+Ritonavir|oral administration of Faldaprevir 240 mg once daily together with DRV/r. Faldaprevir 480 mg loading dose together with DRV/r on the first day.
805875|NCT01374802|E1|Reported Event|Darunavir+Ritonavir|oral administration of darunavir 800 mg once daily coadministered with ritonavir 100 mg (DRV/r)once daily
805876|NCT01374568|B3|Baseline|Total|Total of all reporting groups
805877|NCT01374568|B2|Baseline|Placebo|"Placebo~Placebo: 1 pill daily"
805878|NCT01374568|B1|Baseline|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
805879|NCT01374568|P2|Participant Flow|Placebo|"Placebo~Placebo: 1 pill daily"
805880|NCT01374568|P1|Participant Flow|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
805881|NCT01374568|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill daily"
805882|NCT01374568|O1|Outcome|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
805883|NCT01374568|O2|Outcome|Placebo|"Placebo~Placebo: 1 pill daily"
805884|NCT01374568|O1|Outcome|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
805885|NCT01374568|E2|Reported Event|Placebo|"Placebo~Placebo: 1 pill daily"
805886|NCT01374568|E1|Reported Event|Sitagliptin|"Sitagliptin~sitagliptin: sitagliptin 100mg daily"
805887|NCT01374451|B3|Baseline|Total|Total of all reporting groups
805888|NCT01374451|B2|Baseline|Everolimus|everolimus 10 mg once daily po alone
805889|NCT01374451|B1|Baseline|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805890|NCT01374451|P2|Participant Flow|Everolimus|everolimus 10 mg once daily po alone
805891|NCT01374451|P1|Participant Flow|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805892|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805893|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805894|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805895|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805896|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805897|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805898|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805899|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805900|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805901|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805902|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805903|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805904|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805905|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805906|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805907|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805908|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805909|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805910|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805911|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805912|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805913|NCT01374451|O2|Outcome|Everolimus|everolimus 10 mg once daily po alone
805914|NCT01374451|O1|Outcome|Paseriotide LAR + Everolimus|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805915|NCT01374451|E2|Reported Event|Everolimus|everolimus 10 mg once daily po alone
805916|NCT01374451|E1|Reported Event|Everolimus LAR + Pasireotide|everolimus 10 mg once daily po in combination with pasireotide LAR 60 mg every 28 days (q28d) im
805917|NCT01374438|B3|Baseline|Total|Total of all reporting groups
805918|NCT01374438|B2|Baseline|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805919|NCT01374438|B1|Baseline|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805920|NCT01374438|P2|Participant Flow|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805921|NCT01374438|P1|Participant Flow|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805922|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805923|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805924|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805925|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805926|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805927|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805928|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805929|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805930|NCT01374438|O2|Outcome|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805931|NCT01374438|O1|Outcome|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805932|NCT01374438|E2|Reported Event|Placebo Capsules|"Placebo tablets contained in #00 capsules~Placebo: Placebo capsules given once daily for 90 days"
805933|NCT01374438|E1|Reported Event|MSDC-0160 Capsules|"MSDC tablets contained in #00 capsules~MSDC-0160: MSDC-0160 150 mg capsules given once daily for 90 days"
805934|NCT01374425|B3|Baseline|Total|Total of all reporting groups
805935|NCT01374425|B2|Baseline|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805936|NCT01374425|B1|Baseline|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805937|NCT01374425|P2|Participant Flow|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805938|NCT01374425|P1|Participant Flow|Bevacizumab + mFOLFOX6|Participants with untreated metastatic colorectal cancer (mCRC) who were candidates for first-line therapy received bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) until disease progression or unacceptable toxicity. Bevacizumab was given as 5 milligrams per kilogram (mg/kg), leucovorin as 400 milligrams per meter-squared (mg/m^2), oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via intravenous (IV) infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805939|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
805940|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
805941|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
806157|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
805942|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
807098|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
805943|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
805944|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
805945|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
805946|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
805947|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
805948|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
805949|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
806158|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
806159|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
805950|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
805951|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
805952|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
805953|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Mutant)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with mutant KRAS at Baseline were included in separate analyses.
805954|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (KRAS Wild-Type)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with wild-type KRAS at Baseline were included in separate analyses.
805955|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805956|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805957|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806160|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
806161|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
805967|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
806210|NCT01373450|O1|Outcome|Placebo Period 1|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
805958|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805959|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805960|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805961|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805962|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805963|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805964|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805965|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805966|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806162|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
806995|NCT01370642|B4|Baseline|Total|Total of all reporting groups
805968|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805969|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805970|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805971|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805972|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805973|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805974|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805975|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806027|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
805985|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
807099|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
805976|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805977|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805978|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805979|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805980|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805981|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805982|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805983|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805984|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806163|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
806164|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
805986|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805987|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805988|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805989|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805990|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805991|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805992|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
805993|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
806165|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
806166|NCT01374178|E2|Reported Event|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
806167|NCT01374178|E1|Reported Event|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
805994|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
805995|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
805996|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
805997|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
805998|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
805999|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
806000|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
806001|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
806002|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High, VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA and VEGF-A level >5 pg/mL at Baseline were included in separate analyses.
806168|NCT01374087|B3|Baseline|Total|Total of all reporting groups
806169|NCT01374087|B2|Baseline|Brachytherapy|Brachytherapy: Low or high dose rate.
806011|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
806003|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level ≤5 pg/mL at Baseline were included in separate analyses.
806004|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (VEGF-A High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with VEGF-A level >5 picograms per milliliter (pg/mL) at Baseline were included in separate analyses.
806005|NCT01374425|O2|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806006|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX/FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 or bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Depending on the regimen to which the participant was randomized, bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin or irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806007|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level ≤1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806008|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 Low)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level less than or equal to (≤) 1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806009|NCT01374425|O2|Outcome|Bevacizumab + FOLFIRI (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level >1.7 × 10^-3 ERCC-1/B-actin mRNA at Baseline were included in separate analyses.
806010|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6 (ERCC-1 High)|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles. Participants with ERCC-1 level greater than (>) 1.7 × 10^-3 ERCC-1/B-actin messenger ribonucleic acid (mRNA) at Baseline were included in separate analyses.
806039|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806012|NCT01374425|O1|Outcome|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
806013|NCT01374425|E2|Reported Event|Bevacizumab + FOLFIRI|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus FOLFIRI until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, irinotecan as 180 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
806014|NCT01374425|E1|Reported Event|Bevacizumab + mFOLFOX6|Participants with untreated mCRC who were candidates for first-line therapy received bevacizumab plus mFOLFOX6 until disease progression or unacceptable toxicity. Bevacizumab was given as 5 mg/kg, leucovorin as 400 mg/m^2, oxaliplatin as 85 mg/m^2, and 5-fluorouracil as 400 mg/m^2 bolus followed by 2400 mg/m^2 continuous 46-hour infusion. All treatments were administered via IV infusion and started on Day 1 of each 2-week cycle. Participants could be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin and given as 850 or 1000 mg/m^2 twice a day on Days 1 to 14, with bevacizumab continued in 3-week cycles.
806015|NCT01373671|B1|Baseline|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
806016|NCT01373671|P1|Participant Flow|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
806017|NCT01373671|O2|Outcome|FFDM Only|FFDM exam only
806018|NCT01373671|O1|Outcome|FFDM and DBT|FFDM exam and DBT scan on Siemens MAMMOMAT Inspiration
806019|NCT01373671|E1|Reported Event|Mammography Exam|"Siemens DBT scan~SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM: DBT scan"
806020|NCT01374269|B3|Baseline|Total|Total of all reporting groups
806021|NCT01374269|B2|Baseline|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806022|NCT01374269|B1|Baseline|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806023|NCT01374269|P2|Participant Flow|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806024|NCT01374269|P1|Participant Flow|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806025|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806026|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806201|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
806051|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806211|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
806028|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806029|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806030|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806031|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806032|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806033|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806034|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806035|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806036|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806037|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806038|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806170|NCT01374087|B1|Baseline|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
806040|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806041|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806042|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806043|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806044|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806045|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806046|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806047|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806048|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806049|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806050|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806171|NCT01374087|P2|Participant Flow|Brachytherapy|Brachytherapy: Low or high dose rate.
806202|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
806052|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806053|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806054|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806055|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806056|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806057|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806058|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806059|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806060|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806061|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806073|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806085|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806062|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806063|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806064|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806065|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806066|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806067|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806068|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806069|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806070|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806071|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806072|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806172|NCT01374087|P1|Participant Flow|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
806074|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806075|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806076|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806077|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806078|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806079|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806080|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806081|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806082|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806083|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806084|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806173|NCT01374087|O2|Outcome|Brachytherapy|Brachytherapy: Low or high dose rate.
806203|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
806086|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806087|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806088|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806089|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806090|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806091|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806092|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806093|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806094|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806095|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806107|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806119|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806096|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806097|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806098|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806099|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806100|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806101|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806102|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806103|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806104|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806105|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806106|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806174|NCT01374087|O1|Outcome|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
806108|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806109|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806110|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806111|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806112|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806113|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806114|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806115|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806116|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806117|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806118|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806175|NCT01374087|O2|Outcome|Brachytherapy|Brachytherapy: Low or high dose rate.
806204|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
806120|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806121|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806122|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806123|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806124|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806125|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806126|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806127|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806128|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806129|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806141|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806176|NCT01374087|O1|Outcome|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
806177|NCT01374087|E2|Reported Event|Brachytherapy|Brachytherapy: Low or high dose rate.
806178|NCT01374087|E1|Reported Event|Brachytherapy + Triptorelin 22.5 mg|Brachytherapy: Low or high dose rate. Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
806130|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806131|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806132|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806133|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806134|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806135|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806136|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806137|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806138|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806139|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806140|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806155|NCT01374178|O1|Outcome|LY2963016|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously.
806156|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
806142|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806143|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806144|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806145|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806146|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806147|NCT01374269|O2|Outcome|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806148|NCT01374269|O1|Outcome|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806149|NCT01374269|E2|Reported Event|NSAID|"Naproxen 500 mg per day by 10 days or Celecoxib 200 mg per day by 10 days and Acetaminophen 1,5 a 2 g as rescue~NSAID : The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure."
806150|NCT01374269|E1|Reported Event|Excercise|"One group will be assigned to protocolized back pain exercise, three times a week for 4 weeks. This program is carried out by physiotherapists from participating institutions who wish to participate in research and who will be given a training which will standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. Treatment, type of exercises, exercise tolerance and adverse reactions will be registered~Exercise program : Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week."
806151|NCT01374178|B1|Baseline|Entire Study Population|"For the LY2963016 first, then Lantus group: A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).~For the Lantus first, then LY2963016 group: A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours)."
806152|NCT01374178|P2|Participant Flow|Lantus First, Then LY2963016|A single 0.5-U/kg dose of Lantus was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg dose of LY2963016 was administered subcutaneously during Period 2 (1 period=24 hours).
806153|NCT01374178|P1|Participant Flow|LY2963016 First, Then Lantus|A single 0.5-unit per kilogram (U/kg) dose of LY2963016 was administered subcutaneously during Period 1 (1 period=24 hours), followed by a washout period of at least 7 days before a single 0.5-U/kg Lantus dose was administered subcutaneously during Period 2 (1 period=24 hours).
806154|NCT01374178|O2|Outcome|Lantus|A single 0.5-U/kg dose of Lantus was administered subcutaneously.
806179|NCT01373918|B3|Baseline|Total|Total of all reporting groups
806180|NCT01373918|B2|Baseline|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806181|NCT01373918|B1|Baseline|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806182|NCT01373918|P2|Participant Flow|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806183|NCT01373918|P1|Participant Flow|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806184|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806185|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806186|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806187|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806188|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806189|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806190|NCT01373918|O2|Outcome|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806191|NCT01373918|O1|Outcome|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806192|NCT01373918|E2|Reported Event|Standard Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 3 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806193|NCT01373918|E1|Reported Event|Low Dose Intravenous Fat Emulsion|"Subjects in this arm will receive approximately 1 g/kg/d IV of intravenous soybean oil (Intralipid).~Intralipid: The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first."
806194|NCT01373450|B1|Baseline|All Treated Participants|
806195|NCT01373450|P6|Participant Flow|Pbo--> Lg-0.6--> OXM--> Lg-1.2|Participants received Placebo in the first, Liraglutide 0.6 mg in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Liraglutide 1.2 mg in the fourth period
806196|NCT01373450|P5|Participant Flow|OXM--> Pbo--> Lg-0.6--> Pbo|Participants received Oxyntomodulin 3.0 pmol/kg/min in the first; Placebo in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
806197|NCT01373450|P4|Participant Flow|Lg-0.6--> OXM--> Pbo--> Lg-1.2|Participants received Liraglutide 0.6 mg in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Placebo in the third and Liraglutide 1.2 mg in the fourth period
806198|NCT01373450|P3|Participant Flow|Pbo--> OXM--> Lg-0.6-->Pbo|Participants received Placebo in the first, Oxyntomodulin 3.0 pmol/kg/min in the second, Liraglutide 0.6 mg in the third, and Placebo in the fourth period
806199|NCT01373450|P2|Participant Flow|Lg-0.6 mg--> Pbo--> OXM--> Pbo|Participants received Liraglutide 0.6 mg in the first, Placebo in the second, Oxyntomodulin 3.0 pmol/kg/min in the third, and Placebo in the fourth period
806200|NCT01373450|P1|Participant Flow|OXM --> Lg-0.6--> Pbo--> Lg-1.2|Participants received Oxyntomodulin (OXM) 3.0 pmol/kg/min in the first, Liraglutide (Lg) 0.6 mg in the second, Placebo (Pbo) in the third, and Liraglutide 1.2 mg in the fourth period
806205|NCT01373450|O4|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
806206|NCT01373450|O3|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
806207|NCT01373450|O2|Outcome|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
806208|NCT01373450|O1|Outcome|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
806209|NCT01373450|O2|Outcome|Placebo Period 2|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
806213|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
806214|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
806215|NCT01373450|O2|Outcome|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
806216|NCT01373450|O1|Outcome|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
806217|NCT01373450|E4|Reported Event|Placebo|Placebo for Oxyntomodulin IV infusion and Placebo for Liraglutide subcutaneous
806218|NCT01373450|E3|Reported Event|Liraglutide 1.2 mg|Liraglutide 1.2 mg subcutaneous
806219|NCT01373450|E2|Reported Event|Liraglutide 0.6 mg|Liraglutide 0.6 mg subcutaneous
806220|NCT01373450|E1|Reported Event|Oxyntomodulin|Oxyntomodulin 3.0 pmol/kg/min IV infusion
806221|NCT01373346|B1|Baseline|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
806222|NCT01373346|P1|Participant Flow|Long Limb Roux-en Y Reconstruction|Total or Subtotal gastrectomized gastric cancer patient with long limb Roux en Y reconstruction
806223|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806224|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806225|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806226|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806227|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806228|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806229|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806230|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction : Good Responder Group|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Long limb Roux-en Y reconstruction : Good responder group means patients who showed normal FPG level and HbA1c < 6% without any antidiabetic medications after operation.
806231|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|"Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.~Until end of study (on average 14.8 months), operation related mortality of Gastric cancer patient with type 2 diabetes who receive total or Subtotal gastrectomy with long limb Roux en Y reconstruction were analyzed."
806232|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806233|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806234|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806270|NCT01373281|E1|Reported Event|CYD Dengue Vaccine Group|Safety data were collected in subjects that received at least 1 dose of CYD dengue vaccine.
806271|NCT01372995|B4|Baseline|Total|Total of all reporting groups
807100|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
806235|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806236|NCT01373346|O1|Outcome|Long Limb Roux en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806237|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806238|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806239|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Morbidity after operation were analyzed until end of study (on average 14.8 months)
806240|NCT01373346|O1|Outcome|Long Limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy. Briefly, the gastrointestinal tract was reconstructed by Roux-en Y gastrojejunostomy or esophagojejunostomy after radical gastrectomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis.
806241|NCT01373346|E1|Reported Event|Long-limb Roux-en Y Reconstruction|Long limb Roux-en Y reconstruction means that the length of Roux limb and biliopancreatic limb are longer than conventional reconstruction method after gastrectomy.
806242|NCT01373294|B3|Baseline|Total|Total of all reporting groups
806243|NCT01373294|B2|Baseline|B: Control Arm|Bacille Calmette-Guerrin (BCG).
806244|NCT01373294|B1|Baseline|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
806245|NCT01373294|P2|Participant Flow|B: Control Arm|Bacille Calmette-Guerrin (BCG).
806246|NCT01373294|P1|Participant Flow|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
806247|NCT01373294|O2|Outcome|B: Control Arm|Bacille Calmette-Guerrin (BCG).
806248|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
806249|NCT01373294|O1|Outcome|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
806250|NCT01373294|E2|Reported Event|B: Control Arm|Bacille Calmette-Guerrin (BCG).
806251|NCT01373294|E1|Reported Event|A: Combination Arm|Bacille Calmette-Guerrin (BCG) and lenalidomide.
806252|NCT01373281|B3|Baseline|Total|Total of all reporting groups
806253|NCT01373281|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
806254|NCT01373281|B1|Baseline|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
806255|NCT01373281|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
806256|NCT01373281|P1|Participant Flow|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
806257|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
806258|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
806259|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
806260|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
806261|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
806262|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
806263|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
806264|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
806265|NCT01373281|O2|Outcome|Placebo Group|Subset of subjects who received at least one dose of the placebo vaccine.
806266|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subset of subjects who received at least one dose of CYD Dengue vaccine.
806267|NCT01373281|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo vaccine, one each at 0, 6, and 12 months.
806268|NCT01373281|O1|Outcome|CYD Dengue Vaccine Group|Subjects received 3 doses of CYD dengue vaccine; one each at 0, 6, and 12 months.
806269|NCT01373281|E2|Reported Event|Placebo Group|Safety data were collected in subjects that received at least 1 dose of placebo vaccine.
807101|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
806272|NCT01372995|B3|Baseline|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806273|NCT01372995|B2|Baseline|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806274|NCT01372995|B1|Baseline|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806275|NCT01372995|P3|Participant Flow|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806276|NCT01372995|P2|Participant Flow|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806277|NCT01372995|P1|Participant Flow|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806278|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806279|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806280|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806281|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806282|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806283|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806284|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806285|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806286|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806287|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806288|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806289|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806290|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806291|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806292|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806293|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806294|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806295|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806296|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806297|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806298|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806299|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806300|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806301|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806302|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806303|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806304|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806305|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806306|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806307|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806308|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806309|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806310|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806311|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806481|NCT01371994|P1|Participant Flow|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806312|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806313|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806314|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806315|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806316|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806317|NCT01372995|O3|Outcome|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally
806318|NCT01372995|O2|Outcome|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally
806319|NCT01372995|O1|Outcome|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806320|NCT01372995|E3|Reported Event|500,000 IU of Vitamin D3|Participants randomized to receive 100,000 IU per day of Vitamin D3 for 5 days, for a total dose of 500,000 administered enterally.
806321|NCT01372995|E2|Reported Event|250,000 IU of Vitamin D3|Participants randomized to receive 50,000 IU of Vitamin D3 per day for 5 days, for a total dose of 250,000 IU administered enterally.
806322|NCT01372995|E1|Reported Event|Placebo|Participants randomized to receive an inactive substance administered enterally for 5 days
806323|NCT01372878|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
806324|NCT01372878|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
806325|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
806326|NCT01372878|O1|Outcome|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
806327|NCT01372878|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison"
806328|NCT01372813|B1|Baseline|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806329|NCT01372813|P1|Participant Flow|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806330|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806331|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806332|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806333|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806713|NCT01371721|P1|Participant Flow|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806334|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806373|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806335|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806336|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806337|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806338|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806339|NCT01372813|O1|Outcome|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806340|NCT01372813|E1|Reported Event|Clear Cell Renal Carcinoma Patients|Clear cell renal cancer is a highly vascular tumor characterized by mutations in the von Hippel-Lindau (VHL) gene in the majority of patients, an alteration that leads to overexpression vascular endothelial growth factor (VEGF) as well as other genes such as transforming growth factor-alpha, platelet derived growth factor and glucose transporter 1. Patients received ZD6474 300 mg/day by mouth daily on days 1-28.
806341|NCT01372748|B3|Baseline|Total|Total of all reporting groups
806342|NCT01372748|B2|Baseline|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
806343|NCT01372748|B1|Baseline|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
806344|NCT01372748|P2|Participant Flow|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
806345|NCT01372748|P1|Participant Flow|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
806346|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
806347|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
806348|NCT01372748|O2|Outcome|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
806349|NCT01372748|O1|Outcome|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
806350|NCT01372748|E2|Reported Event|Continuous Chest Compressions|"Continuous compression CPR~Continuous chest compressions: Continuous chest compressions during the first 6 minutes of the resuscitation."
806371|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806399|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
806372|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806351|NCT01372748|E1|Reported Event|Standard CPR|"American Heart Association (AHA)recommended cardiopulmonary resuscitation (CPR) of 30 compressions with brief pause for 2 ventilations~Standard CPR: 30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first."
806352|NCT01372605|B3|Baseline|Total|Total of all reporting groups
806353|NCT01372605|B2|Baseline|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806354|NCT01372605|B1|Baseline|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806355|NCT01372605|P2|Participant Flow|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806356|NCT01372605|P1|Participant Flow|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806357|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806358|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806359|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806360|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806361|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806362|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806363|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806364|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806365|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806366|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806367|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806368|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806369|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806370|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806400|NCT01372462|E4|Reported Event|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
806374|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806375|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806376|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806377|NCT01372605|O2|Outcome|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806378|NCT01372605|O1|Outcome|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806379|NCT01372605|E2|Reported Event|Enhanced Usual Care|Usual care. Enhanced through pre-study training of providers, provision of psychiatric diagnostic information at enrollment to HIV provider, and availability of best-practices guidelines for reference in clinic.
806380|NCT01372605|E1|Reported Event|Collaborative Depression Care|"Measurement-Based Care: Decision support from paraprofessional to HIV medical provider around initiating and monitoring antidepressant treatment.~Measurement-Based Care collaborative depression management: Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications"
806381|NCT01372501|B1|Baseline|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
806382|NCT01372501|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
806383|NCT01372501|O1|Outcome|EndoBarrier Liner Device|Endobarrier Liner: Medical device placed endoscopically in the duodenum
806384|NCT01372501|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
806385|NCT01372501|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
806386|NCT01372462|B1|Baseline|Overall Study Group|Crossover design. Subject were randomized to complete all 4 study arms: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment
806387|NCT01372462|P1|Participant Flow|All Study Participants|"All subjects completed all 4 visit days in which they were randomized to receive which treatment to receive first: 1) NIOV - Oxygen, 2) NIOV - Room Air, 3) Oxygen Nasal Cannula, 4) No treatment.~Study days 1,2,3, and 4; Day 1 for no treatment; day 2 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 3 for no treatment and NIOV - Room Air and NIOV - oxygen; Day 4 for NIOV - oxygen and Nasal Cannula Oxygen."
806388|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
806389|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
806390|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
806391|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
806392|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
806393|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
806394|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
806395|NCT01372462|O1|Outcome|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
806396|NCT01372462|O4|Outcome|No Treatment|Control arm. Subjects exercise without using supplemental oxygen or NIOV.
806397|NCT01372462|O3|Outcome|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
806398|NCT01372462|O2|Outcome|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
806401|NCT01372462|E3|Reported Event|Nasal Cannula Oxygen|"Subjects exercise using a standard nasal cannula using medical oxygen (100% O2).~Nasal Cannula Oxygen: Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen."
806402|NCT01372462|E2|Reported Event|NIOV - Oxygen|"Subjects exercise using the NIOV device powered by compressed medical oxygen (100% O2).~NIOV - Oxygen: Noninvasive ventilation with device powered by compressed medical (100%) oxygen."
806403|NCT01372462|E1|Reported Event|NIOV - Room Air|"Subjects exercise using the NIOV device powered by compressed air (room air, 21% O2).~NIOV - Room Air: Noninvasive ventilation with device powered by compressed room air."
806404|NCT01372410|B1|Baseline|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806405|NCT01372410|P8|Participant Flow|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806406|NCT01372410|P7|Participant Flow|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806407|NCT01372410|P6|Participant Flow|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806408|NCT01372410|P5|Participant Flow|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806409|NCT01372410|P4|Participant Flow|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806410|NCT01372410|P3|Participant Flow|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806411|NCT01372410|P2|Participant Flow|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806412|NCT01372410|P1|Participant Flow|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806413|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806414|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806415|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806416|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806417|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806418|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806513|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806419|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806420|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806421|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806422|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806423|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806424|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806425|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806426|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806427|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806428|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806429|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806430|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806431|NCT01372410|O8|Outcome|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806432|NCT01372410|O7|Outcome|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806433|NCT01372410|O6|Outcome|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806434|NCT01372410|O5|Outcome|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806435|NCT01372410|O4|Outcome|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806436|NCT01372410|O3|Outcome|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806437|NCT01372410|O2|Outcome|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806438|NCT01372410|O1|Outcome|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806439|NCT01372410|O1|Outcome|All Study Treatments|Participants received a sequence containing 3 of the following 8 possible treatments: placebo; UMEC 15.6 µg, 31.25 µg, 62.5 µg, and 125 µg QD; UMEC 15.6 µg and 31.25 µg BID; TIO 18 µg QD. Participants received each of the treatments in 1 of 3 7-day treatment periods, each of which was followed by a Washout Period. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806440|NCT01372410|E8|Reported Event|TIO 18 µg QD|Participants received tiotropium bromide (TIO) 18 µg inhalation capsules via the HandiHaler dry powder inhaler for 7 days in the morning and placebo via the DPI in the evening in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806441|NCT01372410|E7|Reported Event|UMEC 31.25 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806442|NCT01372410|E6|Reported Event|UMEC 15.6 µg BID|Participants received an inhaled dose of a dry powder formulation of UMEC 15.6 µg once in the morning and once in the evening for 7 days via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806443|NCT01372410|E5|Reported Event|UMEC 125 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 125 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806444|NCT01372410|E4|Reported Event|UMEC 62.5 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 62.5 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806445|NCT01372410|E3|Reported Event|UMEC 31.25 µg QD|Participants received an inhaled dose of a dry powder formulation of UMEC 31.25 µg QD for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806446|NCT01372410|E2|Reported Event|UMEC 15.6 µg QD|Participants received an inhaled dose of a dry powder formulation of umeclidinium bromide (UMEC) 15.6 micrograms (µg) once a day (QD) for 7 days in the morning, and matching placebo QD for 7 days in the evening, via a DPI in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806447|NCT01372410|E1|Reported Event|Placebo|Participants received matching placebo once in the morning and once in the evening for 7 days via a dry powder inhaler (DPI) in one of three 7-day treatment periods. Treatment Periods 1 and 2 were followed by a 10- to 14-day Washout Period; Treatment Period 3 was followed by a 7- to 9-day Washout Period before the follow-up phone call.
806448|NCT01372384|B1|Baseline|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
806449|NCT01372384|P1|Participant Flow|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
806450|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
806451|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
806452|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
806453|NCT01372384|O1|Outcome|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
806454|NCT01372384|E1|Reported Event|Erlotinib|Participants received recommended dose of Erlotinib (150 mg/day). No dose escalation of erlotinib was permitted. Participants were treated until disease progression, unacceptable toxicity, death or participant request for discontinuation.
806455|NCT01372150|B4|Baseline|Total|Total of all reporting groups
807355|NCT01369745|E4|Reported Event|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
806456|NCT01372150|B3|Baseline|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
806457|NCT01372150|B2|Baseline|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
806595|NCT01371786|B3|Baseline|Total|Total of all reporting groups
806458|NCT01372150|B1|Baseline|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
806459|NCT01372150|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release (DVS SR)|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
806460|NCT01372150|P2|Participant Flow|Fluoxetine|Fluoxetine capsules 10 (milligram) mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily as appropriate for 1 week (taper/transition phase).
806461|NCT01372150|P1|Participant Flow|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
806462|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
806463|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
806464|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
806465|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
806466|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
806467|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
806468|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
806469|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
806470|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
806471|NCT01372150|O3|Outcome|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
806472|NCT01372150|O2|Outcome|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
806473|NCT01372150|O1|Outcome|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
806474|NCT01372150|E3|Reported Event|DVS SR|DVS SR capsules 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) (taper phase) or 25 mg (transition phase) administered once daily as appropriate for 1 week.
806475|NCT01372150|E2|Reported Event|Fluoxetine|Fluoxetine capsules 10 mg administered once daily for the first week of treatment (titration phase) then 20 mg administered once daily for the next 7 weeks of treatment, followed by placebo capsules administered once daily for 1 week as appropriate (taper/transition phase).
806476|NCT01372150|E1|Reported Event|Placebo|Placebo tablets and capsules administered once daily for 8 weeks (treatment phase), followed by placebo tablets and capsules administered once daily as appropriate for 1 week (taper/transition phase).
806477|NCT01371994|B3|Baseline|Total|Total of all reporting groups
806546|NCT01371838|B1|Baseline|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806478|NCT01371994|B2|Baseline|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806479|NCT01371994|B1|Baseline|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806480|NCT01371994|P2|Participant Flow|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806482|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806483|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806484|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806485|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806486|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806487|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806488|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806489|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806490|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806491|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806492|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806493|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806494|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806495|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806496|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806497|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806498|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806499|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806500|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806501|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806502|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806503|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806504|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806505|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806506|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806507|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806508|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806509|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806510|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806511|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806512|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806514|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806515|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806516|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806517|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806518|NCT01371994|O2|Outcome|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806519|NCT01371994|O1|Outcome|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806520|NCT01371994|E2|Reported Event|Solifenacin Succinate|Participants received 5 mg solifenacin succinate tablets once a day for 12 weeks. At week 4, based on efficacy and safety and in agreement with the investigator, the dose might be increased to 10 mg (2 tablets of 5 mg) once daily.
806521|NCT01371994|E1|Reported Event|Placebo|Participants received matching placebo tablets once a day for 12 weeks.
806522|NCT01371877|B3|Baseline|Total|Total of all reporting groups
806523|NCT01371877|B2|Baseline|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
806524|NCT01371877|B1|Baseline|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
806525|NCT01371877|P2|Participant Flow|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
806526|NCT01371877|P1|Participant Flow|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
806527|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
806528|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
806529|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
806530|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
806531|NCT01371877|O2|Outcome|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
806532|NCT01371877|O1|Outcome|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
806533|NCT01371877|E2|Reported Event|Low Dose Vitamin D|"Subjects will be randomized 1:1 to low dose vitamin D as defined as 600 IU per day for 3 months.~Vitamin D: Vitamin D 600 IU per day"
806534|NCT01371877|E1|Reported Event|High Dose Vitamin D|"Subjects will be randomized 1:1 to high dose vitamin D defined as 4000 IU per day for 3 months.~Vitamin D: Vitamin D 4000 IU per day for 3 months"
806535|NCT01371851|B3|Baseline|Total|Total of all reporting groups
806536|NCT01371851|B2|Baseline|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806537|NCT01371851|B1|Baseline|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806538|NCT01371851|P2|Participant Flow|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806539|NCT01371851|P1|Participant Flow|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806540|NCT01371851|O2|Outcome|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806541|NCT01371851|O1|Outcome|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806542|NCT01371851|E2|Reported Event|Placebo|"Participants will be maintained on placebo (cellulose) throughout the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806543|NCT01371851|E1|Reported Event|Doxazosin|"Doxazosin extended release will be administered initially at 4 mg/day. On day 8 the dose is increased to 8 mg/day and the participant is maintained on the study until the end of the trial.~Doxazosin extended release: initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial."
806544|NCT01371838|B3|Baseline|Total|Total of all reporting groups
806545|NCT01371838|B2|Baseline|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806547|NCT01371838|P2|Participant Flow|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806548|NCT01371838|P1|Participant Flow|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806549|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806550|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806551|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806552|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806553|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806554|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806555|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806556|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806557|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806558|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806559|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806560|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806561|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806562|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806563|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806564|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806565|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806566|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806567|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806568|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806569|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806570|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806571|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806572|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806573|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806574|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806575|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806576|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806577|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806578|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806579|NCT01371838|O2|Outcome|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806580|NCT01371838|O1|Outcome|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806581|NCT01371838|E2|Reported Event|Ceftriaxone 2g|Ceftriaxone for Injection is supplied as 1 g/vial (2 vials for a 2 grams dose) and a 2 grams dose infused over 30 (±10) minutes q24h (±2h).
806582|NCT01371838|E1|Reported Event|Ceftaroline 600mg|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
806583|NCT01371825|B1|Baseline|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806584|NCT01371825|P1|Participant Flow|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806585|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806586|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806587|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806588|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806589|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806590|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806591|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806592|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806593|NCT01371825|O1|Outcome|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806627|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806628|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
807356|NCT01369745|E3|Reported Event|Prednisone|Prednisone 5 mg once daily
806594|NCT01371825|E1|Reported Event|Open-Label Sebelipase Alfa|Subjects received IV infusions of sebelipase alfa at a starting dose of 0.35 mg/kg once weekly (qw). Dose was escalated to 1 mg/kg qw once acceptable safety and tolerability had been demonstrated during at least 2 infusions at the dose of 0.35 mg/kg. In the event of disease progression, based on protocol-defined criteria, subjects could be considered for further dose increase to 3 mg/kg qw. Dose escalation to 5 mg/kg qw in subjects who had evidence of continued disease progression was optional. Subjects receiving long-term treatment on a stable qw dose could be switched to an every other week (qow) dosing schedule at the same total dose (mg/kg) per infusion.
806596|NCT01371786|B2|Baseline|Sequence Mometasone Aqueous / Ciclesonide Nasal Aerosol|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canistermometasone Aqueous (AQ) nasal spray : A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806597|NCT01371786|B1|Baseline|Sequence Ciclesonide Nasal Aerosol /Mometsasone Aqueous|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806598|NCT01371786|P2|Participant Flow|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle followed by a washout period of 120 hours and a radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
806599|NCT01371786|P1|Participant Flow|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister followed by a washout period of 120 hours and a radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806600|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806601|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
806602|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806603|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
806604|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806605|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
806606|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806607|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
806608|NCT01371786|O2|Outcome|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806609|NCT01371786|O1|Outcome|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
806610|NCT01371786|E2|Reported Event|Mometasone|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
806611|NCT01371786|E1|Reported Event|Ciclesonide Nasal Aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
806612|NCT01371747|B7|Baseline|Total|Total of all reporting groups
806613|NCT01371747|B6|Baseline|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806614|NCT01371747|B5|Baseline|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day
806615|NCT01371747|B4|Baseline|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806616|NCT01371747|B3|Baseline|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806617|NCT01371747|B2|Baseline|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806618|NCT01371747|B1|Baseline|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806619|NCT01371747|P6|Participant Flow|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806620|NCT01371747|P5|Participant Flow|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806621|NCT01371747|P4|Participant Flow|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806622|NCT01371747|P3|Participant Flow|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806623|NCT01371747|P2|Participant Flow|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806624|NCT01371747|P1|Participant Flow|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806625|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806626|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806629|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806630|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806631|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806717|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806632|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806633|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806634|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806635|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806636|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day
806637|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806638|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806639|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806640|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806641|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806642|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806643|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806644|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806645|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806646|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806647|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806648|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806649|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806650|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806651|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806652|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806653|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806654|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806655|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806656|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806657|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806658|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806659|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806660|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806661|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806829|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
806662|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806663|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806664|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806665|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806666|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806667|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806668|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806669|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806670|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806671|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806672|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806673|NCT01371747|O6|Outcome|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806674|NCT01371747|O5|Outcome|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806675|NCT01371747|O4|Outcome|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806676|NCT01371747|O3|Outcome|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806677|NCT01371747|O2|Outcome|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806678|NCT01371747|O1|Outcome|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806679|NCT01371747|E6|Reported Event|Stratum 2: 33.6 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
806680|NCT01371747|E5|Reported Event|Stratum 2: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806681|NCT01371747|E4|Reported Event|Stratum 2: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.5 to < 6.0 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806682|NCT01371747|E3|Reported Event|Stratum 1: 25.2 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
806683|NCT01371747|E2|Reported Event|Stratum 1: 16.8 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 16.8 g/day patiromer starting dose, orally, as a divided dose twice a day.
806684|NCT01371747|E1|Reported Event|Stratum 1: 8.4 g/d Patiromer|Participants with baseline serum potassium > 5.0 - 5.5 mEq/L randomized to 8.4 g/day patiromer starting dose, orally, as a divided dose twice a day.
806685|NCT01371734|B4|Baseline|Total|Total of all reporting groups
806686|NCT01371734|B3|Baseline|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806687|NCT01371734|B2|Baseline|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806688|NCT01371734|B1|Baseline|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806689|NCT01371734|P3|Participant Flow|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806690|NCT01371734|P2|Participant Flow|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806691|NCT01371734|P1|Participant Flow|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806715|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806716|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806692|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806693|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806694|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806695|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806696|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806697|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806698|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806699|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806700|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806701|NCT01371734|O3|Outcome|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806702|NCT01371734|O2|Outcome|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806703|NCT01371734|O1|Outcome|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806704|NCT01371734|E3|Reported Event|DVS SR High Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 25, 35 or 50 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806705|NCT01371734|E2|Reported Event|DVS SR Low Dose|DVS SR tablets 10 or 20 mg (based on weight at the baseline visit) administered once daily for the first week of treatment (titration phase) then 20, 25 or 35 mg (based on weight at the baseline visit) administered once daily for the next 7 weeks of treatment, followed by 10 or 20 mg (based on weight at the baseline visit) administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806706|NCT01371734|E1|Reported Event|Placebo|Matched placebo tablets administered once daily for 8 weeks (treatment phase), followed by placebo tablets administered once daily for 1 week (taper phase) only for those participants not entering the extension study.
806707|NCT01371721|B4|Baseline|Total|Total of all reporting groups
806708|NCT01371721|B3|Baseline|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806709|NCT01371721|B2|Baseline|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806710|NCT01371721|B1|Baseline|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806711|NCT01371721|P3|Participant Flow|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806712|NCT01371721|P2|Participant Flow|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806714|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
807102|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
806718|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806719|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806720|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806721|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806722|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806723|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806724|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806725|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806726|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806727|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806728|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806729|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806730|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806731|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806732|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806733|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806734|NCT01371721|O4|Outcome|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806735|NCT01371721|O3|Outcome|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806736|NCT01371721|O2|Outcome|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806737|NCT01371721|O1|Outcome|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806738|NCT01371721|E4|Reported Event|Combination|Combination of 3 groups from previous study B2061014 who received DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806739|NCT01371721|E3|Reported Event|Desvenlafaxine Succinate Sustained Release / DVS SR|DVS SR weight based (25 mg, 35 mg, 50 mg) in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806740|NCT01371721|E2|Reported Event|Fluoxetine / DVS SR|Fluoxetine 20 mg in previous study B2061014 /DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806741|NCT01371721|E1|Reported Event|Placebo / DVS SR|Placebo in previous study B2061014/DVS SR flexible dose 20 mg – 50 mg in extension study B2061031
806742|NCT01371708|B4|Baseline|Total|Total of all reporting groups
806743|NCT01371708|B3|Baseline|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806744|NCT01371708|B2|Baseline|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806745|NCT01371708|B1|Baseline|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806746|NCT01371708|P3|Participant Flow|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806747|NCT01371708|P2|Participant Flow|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806748|NCT01371708|P1|Participant Flow|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806749|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
806750|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806751|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806752|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806753|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
806754|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806755|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806756|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806757|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
806758|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806759|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806760|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806761|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
806762|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806763|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806764|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806765|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
806766|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806767|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806768|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806769|NCT01371708|O1|Outcome|Combination Group|Combination of 3 groups of participants from previous study B2061032 received desvenlafaxine succinate sustained release in flexible dosing ranging from 20 to 50 mg in the current extension study, B2061030.
806770|NCT01371708|O3|Outcome|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806771|NCT01371708|O2|Outcome|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806772|NCT01371708|O1|Outcome|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806773|NCT01371708|E4|Reported Event|Combination Group|Combination of 3 groups of participants from previous study B2061032 received DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806774|NCT01371708|E3|Reported Event|DVS-SR, High Dose/DVS-SR|Participants received DVS-SR in weight-based dosing (25, 35, or 50 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806775|NCT01371708|E2|Reported Event|DVS-SR, Low Dose/DVS-SR|Participants received DVS-SR in weight-based dosing(20, 25, or 35 mg) in previous study B2061032, and DVS-SR in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806776|NCT01371708|E1|Reported Event|Placebo/DVS-SR|Participants received placebo tablets in previous study B2061032 and desvenlafaxine succinate sustained-release (DVS-SR) in flexible dosing ranging from 20 to 50 mg in extension study B2061030.
806777|NCT01371643|B3|Baseline|Total|Total of all reporting groups
806778|NCT01371643|B2|Baseline|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
806779|NCT01371643|B1|Baseline|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
806780|NCT01371643|P2|Participant Flow|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
806781|NCT01371643|P1|Participant Flow|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
806782|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
806783|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
806784|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
806785|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
806786|NCT01371643|O2|Outcome|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
806787|NCT01371643|O1|Outcome|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
806788|NCT01371643|E2|Reported Event|Surgical Debulking Followed by Octreotide LAR|"Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured~Octreotide LAR~transsphenoidal surgery"
806789|NCT01371643|E1|Reported Event|Medical Treatment by Octreotide LAR|"Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery~Octreotide LAR"
806790|NCT01371565|B1|Baseline|Mifepristone|At doses from 300mg/day up to 1200mg/day
806791|NCT01371565|P1|Participant Flow|Mifepristone|At doses from 300mg/day up to 1200mg/day
806792|NCT01371565|O1|Outcome|Mifepristone|At doses from 300mg/day up to 1200mg/day
806793|NCT01371565|E1|Reported Event|Mifepristone|At doses from 300mg/day up to 1200mg/day
806794|NCT01371552|B1|Baseline|Overall Study|This reporting group includes all enrolled participants.
806795|NCT01371552|P6|Participant Flow|Filcon II 3 / Delefilcon A / Narafilcon A|Part 1: Filcon II 3, then Delefilcon A, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
806796|NCT01371552|P5|Participant Flow|Narafilcon A / Delefilcon A / Filcon II 3|Part 1: Narafilcon A, then Delefilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
806797|NCT01371552|P4|Participant Flow|Delefilcon A / Narafilcon A / Filcon II 3|Part 1: Delefilcon A, then Narafilcon A, then Filcon II 3, 3 days each. Part 2: Delefilcon A for 1 week.
806798|NCT01371552|P3|Participant Flow|Filcon II 3 / Narafilcon A / Delefilcon A|Part 1: Filcon II 3, then Narafilcon A, the Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
806799|NCT01371552|P2|Participant Flow|Narafilcon A / Filcon II 3 / Delefilcon A|Part 1: Narafilcon A, then Filcon II 3, then Delefilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
806800|NCT01371552|P1|Participant Flow|Delefilcon A / Filcon II 3 / Narafilcon A|Part 1: Delefilcon A, then Filcon II 3, then Narafilcon A, 3 days each. Part 2: Delefilcon A for 1 week.
806801|NCT01371552|O1|Outcome|Delefilcon A - All Wearers|Delefilcon A contact lenses worn in a daily disposable mode for 7 days in Part 2, all wearers
806802|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806803|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806804|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806805|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806806|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806807|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806808|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806809|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806810|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806811|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806812|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806813|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806814|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806815|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806816|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806817|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806818|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806819|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806820|NCT01371552|O3|Outcome|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806821|NCT01371552|O2|Outcome|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806822|NCT01371552|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806823|NCT01371552|E3|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806824|NCT01371552|E2|Reported Event|Filcon II 3|Filcon II 3 contact lenses worn in a daily disposable mode for 3 days in Part 1
806825|NCT01371552|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in a daily disposable mode for 3 days in Part 1
806826|NCT01371539|B1|Baseline|Overall|All enrolled and dispensed participants
806827|NCT01371539|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A contact lenses worn first, with lotrafilcon B contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
806828|NCT01371539|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B contact lenses worn first, with comfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear basis for one week each.
806830|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
806831|NCT01371539|O2|Outcome|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
806832|NCT01371539|O1|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
806833|NCT01371539|E2|Reported Event|Comfilcon A|Comfilcon A contact lenses worn bilaterally on a daily wear basis for one week.
806834|NCT01371539|E1|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn bilaterally on a daily wear basis for one week.
806835|NCT01371006|B3|Baseline|Total|Total of all reporting groups
806836|NCT01371006|B2|Baseline|Group B: 600 mg Efavirenz+240 mg Feldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
806837|NCT01371006|B1|Baseline|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806838|NCT01371006|P2|Participant Flow|Group B: 600 mg Efavirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
806839|NCT01371006|P1|Participant Flow|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806840|NCT01371006|O5|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
806841|NCT01371006|O4|Outcome|Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam
806842|NCT01371006|O3|Outcome|Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam.
806843|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
806844|NCT01371006|O1|Outcome|Midazolam|Treatment with single-dose Midazolam.
806845|NCT01371006|O4|Outcome|Total On-treatment|Total number of participants with drug related adverse events during treatment.
806846|NCT01371006|O3|Outcome|Efavirenz+Faldaprevir|During treatment with Faldaprevir and single-dose Efavirenz.
806847|NCT01371006|O2|Outcome|Faldaprevir|During treatment with Faldaprevir.
806848|NCT01371006|O1|Outcome|Efavirenz|Treatment with single-dose Efavirenz.
806849|NCT01371006|O2|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
806850|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806851|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
806852|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
806853|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
806854|NCT01371006|O1|Outcome|Group B: 600 mg Efivirenz+240 mg Faldaprevir+7.5 mg Midazolam|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 2 followed by 240 mg doses twice a day until day 18.~Efavirenz (film-coated tablet): 600 mg on days 10 to 18 once a day. Midazolam (tablet): Single dose (7.5 mg) on day 1, 9 and 18.~oral administration with water after food intake."
806855|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806856|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806857|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806858|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806859|NCT01371006|O1|Outcome|Group A: 240 mg Faldaprevir+50 mg Efavirenz|"Faldaprevir (soft gel capsule): Loading dose (480 mg) on day 7 followed by 240 mg doses twice a day until day 19.~Efavirenz (film-coated tablet): Single dose (50 mg) on day 1 and 14.~oral administration with water after food intake."
806860|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
806861|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
806862|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
806863|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
806864|NCT01371006|O2|Outcome|7.5 mg Midazolam+240 mg Faldaprevir+600 mg Efavirenz|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir and with multiple oral administration of 600 mg Efavirenz (Day 18)
807103|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
806865|NCT01371006|O1|Outcome|7.5 mg Midazolam+240 mg Faldaprevir|single oral administration of 7.5 mg Midazolam and multiple oral administration of 240 mg Faldaprevir (Day 9)
806866|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
806867|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
806868|NCT01371006|O2|Outcome|50 mg Efavirenz+240 mg Faldaprevir|single oral administration of 50 mg Efavirenz dosed with Faldaprevir at steady state (Day 14)
806869|NCT01371006|O1|Outcome|50 mg Efavirenz|single oral administration of 50 mg Efavirenz dosed alone (Day 1)
806870|NCT01371006|E7|Reported Event|Group B: Faldaprevir+Midazolam+Efavirenz|During treatment with Faldaprevir, Efavirenz, and single-dose Midazolam in Group B.
806871|NCT01371006|E6|Reported Event|Group B: Faldaprevir+Midazolam|During treatment with Faldaprevir and single-dose Midazolam in Group B.
806872|NCT01371006|E5|Reported Event|Group B: Faldaprevir|During treatment with Faldaprevir in Group B.
806873|NCT01371006|E4|Reported Event|Group B: Midazolam|Treatment with single-dose Midazolam in Group B.
806874|NCT01371006|E3|Reported Event|Group A: Faldaprevir+Efavirenz|During treatment with Faldaprevir and single-dose Efavirenz in Group A.
806875|NCT01371006|E2|Reported Event|Group A: Faldaprevir|During treatment with Faldaprevir in Group A.
806876|NCT01371006|E1|Reported Event|Group A: Efavirenz|Treatment with single-dose Efavirenz in Group A.
806877|NCT01370863|B3|Baseline|Total|Total of all reporting groups
806878|NCT01370863|B2|Baseline|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
806879|NCT01370863|B1|Baseline|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
806880|NCT01370863|P2|Participant Flow|Placebo|Matching placebo tablet administered three times daily (t.i.d.) for 4 weeks in addition to stable PPI treatment
806881|NCT01370863|P1|Participant Flow|SPD557|0.5 mg tablet administered 3 times daily (t.i.d.) for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
806882|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
806883|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
806884|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
806885|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
806886|NCT01370863|O2|Outcome|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
806887|NCT01370863|O1|Outcome|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
806888|NCT01370863|E2|Reported Event|Placebo|Matching placebo tablet t.i.d. for 4 weeks in addition to stable PPI treatment
806889|NCT01370863|E1|Reported Event|SPD557|0.5 mg tablet t.i.d. for 4 weeks in addition to stable proton pump inhibitor (PPI) treatment
806890|NCT01370837|B4|Baseline|Total|Total of all reporting groups
806891|NCT01370837|B3|Baseline|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806892|NCT01370837|B2|Baseline|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806893|NCT01370837|B1|Baseline|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806894|NCT01370837|P3|Participant Flow|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806895|NCT01370837|P2|Participant Flow|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806896|NCT01370837|P1|Participant Flow|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806939|NCT01370655|B12|Baseline|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
806897|NCT01370837|O3|Outcome|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806920|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806898|NCT01370837|O2|Outcome|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806899|NCT01370837|O1|Outcome|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806900|NCT01370837|E3|Reported Event|Polyneuropathy|"Patients with diabetes and polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806901|NCT01370837|E2|Reported Event|Diabetes|"Patients with diabetes mellitus without polyneuropathy.~Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806902|NCT01370837|E1|Reported Event|Healthy Controls|"Intracutaneous injection of Candida albicans antigen.: Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.~Temperature measurement.: Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer."
806903|NCT01370733|B3|Baseline|Total|Total of all reporting groups
806904|NCT01370733|B2|Baseline|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806905|NCT01370733|B1|Baseline|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806906|NCT01370733|P2|Participant Flow|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806907|NCT01370733|P1|Participant Flow|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806908|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806909|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806910|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806911|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806912|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806913|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806914|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806915|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806916|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806917|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806918|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806940|NCT01370655|B11|Baseline|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
806919|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806943|NCT01370655|B8|Baseline|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
806921|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806922|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806923|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806924|NCT01370733|O2|Outcome|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806925|NCT01370733|O1|Outcome|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806926|NCT01370733|E2|Reported Event|Sham|"Treatment with a sham (inactive) device, identical in sound and appearance to the NEST-1 Device~SHAM: The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered."
806927|NCT01370733|E1|Reported Event|Active sTMS|"Treatment with the NEST-1 Device~NEST-1 (NeoSync EEG Synchronized TMS): The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder."
806928|NCT01370694|B1|Baseline|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806929|NCT01370694|P1|Participant Flow|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806930|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806931|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806932|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806933|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806934|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806935|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806936|NCT01370694|O1|Outcome|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806937|NCT01370694|E1|Reported Event|MK-8808 Combination Therapy|Participants received MK-8808 375 mg/m^2 intravenously (IV) + cyclophosphamide 750 mg/m^2 IV + vincristine 1.4 mg/m^2 IV (maximum dose of 2 mg IV) on Day 1 each cycle, plus prednisolone 40 mg/m^2, orally on Days 1 to 5 of each cycle for a maximum of 8 cycles. Participants receiving clinical benefit could remain on MK-8808 375 mg/m^2 IV starting 8 weeks after last dose of combination therapy, every 2 months for up to 2 years.
806938|NCT01370655|B13|Baseline|Total|Total of all reporting groups
806941|NCT01370655|B10|Baseline|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
806942|NCT01370655|B9|Baseline|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
807095|NCT01370538|P2|Participant Flow|Placebo|Placebo for Esomeprazole
806944|NCT01370655|B7|Baseline|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
806945|NCT01370655|B6|Baseline|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
806946|NCT01370655|B5|Baseline|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
806947|NCT01370655|B4|Baseline|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
806948|NCT01370655|B3|Baseline|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
806949|NCT01370655|B2|Baseline|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
806950|NCT01370655|B1|Baseline|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
806951|NCT01370655|P12|Participant Flow|Treatment D → Treament B|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
806952|NCT01370655|P11|Participant Flow|Treatment B → Treatment D|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-715 daily for 4 weeks.
806953|NCT01370655|P10|Participant Flow|Treatment C → Treatment B|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
806954|NCT01370655|P9|Participant Flow|Treatment B → Treatment C|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg daily for 4 weeks.
806955|NCT01370655|P8|Participant Flow|Treatment B → Treatment A|Participants received 3 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
806956|NCT01370655|P7|Participant Flow|Treatment A → Treatment B|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received 3 mg MK-7145 daily for 4 weeks.
806957|NCT01370655|P6|Participant Flow|Treatment C → Treatment D|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
806958|NCT01370655|P5|Participant Flow|Treament D → Treatment C|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received HCTZ 25 mg placebo daily for 4 weeks.
806959|NCT01370655|P4|Participant Flow|Treatment D → Treatment A|Participants received Placebo MK-7145 daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
806960|NCT01370655|P3|Participant Flow|Treatment A → Treatment D|Participants received 6 mg MK-7145 daily for 4 weeks and then after a 4-week washout, received Placebo MK-7145 daily for 4 weeks.
806961|NCT01370655|P2|Participant Flow|Treatment C → Treatment A|Participants received HCTZ 25 mg daily for 4 weeks and then after a 4-week washout, received 6 mg MK-7145 daily for 4 weeks.
806962|NCT01370655|P1|Participant Flow|Treatment A → Treatment C|Participants received 6 mg MK-7145 for 4 weeks and then after a 4 week washout, received HCTZ 25 mg, daily, for 4 weeks
806963|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
806964|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
806965|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
806966|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
806967|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
806968|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
806969|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
806970|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
806971|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
806972|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
806973|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
806974|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
806975|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
806976|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
806977|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
806978|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
806979|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
806980|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
806981|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
806982|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
806983|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
806984|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
806985|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
806986|NCT01370655|O1|Outcome|MK-7145 3 mg|Participants received 3 mg MK-7145 daily for 4 weeks
806987|NCT01370655|O4|Outcome|Placebo|Participants received Placebo MK-7145 daily for 4 weeks
806988|NCT01370655|O3|Outcome|HCTZ 25 mg|Participants received HCTZ 25 mg daily for 4 weeks
806989|NCT01370655|O2|Outcome|MK-7145 6 mg|Participants received 6 mg MK-7145 for 4 weeks
806996|NCT01370642|B3|Baseline|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
806997|NCT01370642|B2|Baseline|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807096|NCT01370538|P1|Participant Flow|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807097|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
806998|NCT01370642|B1|Baseline|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
806999|NCT01370642|P3|Participant Flow|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807000|NCT01370642|P2|Participant Flow|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807001|NCT01370642|P1|Participant Flow|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807002|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807003|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807004|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807005|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807006|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807007|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807008|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807009|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807010|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807011|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807012|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807013|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807014|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807015|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807016|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807017|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807018|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807019|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807020|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807021|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807022|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807023|NCT01370642|O3|Outcome|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807024|NCT01370642|O2|Outcome|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807025|NCT01370642|O1|Outcome|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807026|NCT01370642|E3|Reported Event|Control Arm|Participants on this arm receive 24 weeks of treatment with placebo to vaniprevir along with 48 weeks of treatment with peg-IFN and RBV.
807027|NCT01370642|E2|Reported Event|Vaniprevir 24 Week Arm|Participants on this arm receive 24 weeks of vaniprevir (300 mg twice daily) along with 24 weeks of treatment with peg-IFN and RBV.
807028|NCT01370642|E1|Reported Event|Vaniprevir 12 Week Arm|Participants on this arm receive 12 weeks of vaniprevir (300 mg twice daily) and then 12 weeks of placebo to vaniprevir along with 24 weeks of treatment with peg-IFN and RBV.
807029|NCT01370616|B3|Baseline|Total|Total of all reporting groups
807030|NCT01370616|B2|Baseline|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807031|NCT01370616|B1|Baseline|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807032|NCT01370616|P2|Participant Flow|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807033|NCT01370616|P1|Participant Flow|Ertapenem Sodium|Participants received 1.0 g intravenous (IV) ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807034|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807035|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807036|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807037|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807038|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807039|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807040|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807041|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807042|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807043|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807044|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807045|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807046|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807047|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807048|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807049|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807050|NCT01370616|O2|Outcome|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807357|NCT01369745|E2|Reported Event|Dipyridamole|dipyridamole 360 mg once daily
807051|NCT01370616|O1|Outcome|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807052|NCT01370616|E2|Reported Event|Piperacillin/Tazobactam Sodium|Participants received 4.5 g IV piperacillin/tazobactam at Hours 0, 8, and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807053|NCT01370616|E1|Reported Event|Ertapenem Sodium|Participants received 1.0 g IV ertapenem sodium as a single daily dose at Hour 0 infused over a 30-minute interval , and IV piperacillin/tazobactam-matching placebo at Hours 8 and 16 infused over a 30-minute interval, for 5 to 28 days. Participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
807054|NCT01370603|B3|Baseline|Total|Total of all reporting groups
807055|NCT01370603|B2|Baseline|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
807056|NCT01370603|B1|Baseline|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
807057|NCT01370603|P2|Participant Flow|Combination/Co-administration Sequence|Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg
807058|NCT01370603|P1|Participant Flow|Co-administration/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 40 mg then Ezetimibe/Atorvastatin 10 mg/40 mg fixed-dose combination
807059|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
807060|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
807061|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
807062|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
807063|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
807064|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
807065|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
807066|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
807067|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
807068|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
807069|NCT01370603|O2|Outcome|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 40 mg once daily for 6 weeks
807070|NCT01370603|O1|Outcome|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
807071|NCT01370603|E2|Reported Event|Co-Administration Ezetimibe and Atorvastatin|Ezetimibe 10 mg co-administered with atorvastatin 20 mg once daily for 6 weeks
807072|NCT01370603|E1|Reported Event|Ezetimibe/Atorvastatin Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet once daily for 6 weeks
807073|NCT01370590|B3|Baseline|Total|Total of all reporting groups
807074|NCT01370590|B2|Baseline|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
807075|NCT01370590|B1|Baseline|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
807076|NCT01370590|P2|Participant Flow|Combination/Coadministered Sequence|Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination then Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg
807077|NCT01370590|P1|Participant Flow|Coadministered/Combination Sequence|Co-administration Ezetimibe 10 mg and Atorvastatin 20 mg then Ezetimibe/Atorvastatin 10 mg/20 mg fixed-dose combination
807078|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
807079|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
807080|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
807081|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
807082|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
807083|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
807084|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
807085|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
807086|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
807087|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
807088|NCT01370590|O2|Outcome|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
807089|NCT01370590|O1|Outcome|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
807090|NCT01370590|E2|Reported Event|Co-Administration Ezetimibe and Atorvastin|"Ezetimibe 10 mg co-administered with~atorvastatin 20 mg once daily for 6 weeks"
807091|NCT01370590|E1|Reported Event|Ezetimibe/Atorva Fixed Dose Combination|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet once daily for 6 weeks
807092|NCT01370538|B3|Baseline|Total|Total of all reporting groups
807093|NCT01370538|B2|Baseline|Placebo|Placebo for Esomeprazole
807094|NCT01370538|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807104|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807105|NCT01370538|O2|Outcome|Placebo|Placebo for Esomeprazole
807106|NCT01370538|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807107|NCT01370538|E2|Reported Event|Placebo|Placebo for Esomeprazole
807108|NCT01370538|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807109|NCT01370525|B3|Baseline|Total|Total of all reporting groups
807110|NCT01370525|B2|Baseline|Placebo|Placebo for Esomeprazole
807111|NCT01370525|B1|Baseline|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807112|NCT01370525|P2|Participant Flow|Placebo|Placebo for Esomeprazole
807113|NCT01370525|P1|Participant Flow|Esomeprazole|Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate
807114|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
807115|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807116|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
807117|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807118|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
807119|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807120|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
807121|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807122|NCT01370525|O2|Outcome|Placebo|Placebo for Esomeprazole
807123|NCT01370525|O1|Outcome|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807124|NCT01370525|E2|Reported Event|Placebo|Placebo for Esomeprazole
807125|NCT01370525|E1|Reported Event|Esomeprazole|Esomeprazole magnesium trihydrate 22.3 mg
807126|NCT01370460|B3|Baseline|Total|Total of all reporting groups
807127|NCT01370460|B2|Baseline|Placebo|100mL 0.9% NS, applied topically
807128|NCT01370460|B1|Baseline|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
807129|NCT01370460|P2|Participant Flow|Placebo|100mL 0.9% NS, applied topically
807130|NCT01370460|P1|Participant Flow|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
807131|NCT01370460|O2|Outcome|Placebo|100mL 0.9% NS, applied topically
807132|NCT01370460|O1|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
807133|NCT01370460|O2|Outcome|Tranexamic Acid|Topical tranexamic acid (2g/100mL) applied during unilateral total knee arthroplasty.
807134|NCT01370460|O1|Outcome|Placebo|100mL 0.9% NS, applied topically
807135|NCT01370460|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
807136|NCT01370408|B1|Baseline|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807137|NCT01370408|P1|Participant Flow|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807138|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807139|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807158|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
807206|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807140|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807141|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807142|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807143|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807144|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807145|NCT01370408|O1|Outcome|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807146|NCT01370408|E1|Reported Event|Palonosetron|"All patients will receive the following medications prior to and during their high dose chemotherapy for autologous stem cell transplantation~Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO~Palonosetron, ondansetron, dexamethasone: Day x-y of IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV Day z (last day of chemotherapy) - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO"
807147|NCT01370356|B3|Baseline|Total|Total of all reporting groups
807148|NCT01370356|B2|Baseline|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
807149|NCT01370356|B1|Baseline|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. One participant was assigned to varenicline as a male but is in fact female. Data below are presented for the treated population.
807150|NCT01370356|P2|Participant Flow|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed. Data below are presented for the treated population.
807151|NCT01370356|P1|Participant Flow|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg twice daily [BID]). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID. Data below are presented for the treated population.
807152|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
807153|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
807154|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
807155|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
807156|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
807157|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
807159|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
807160|NCT01370356|O2|Outcome|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
807161|NCT01370356|O1|Outcome|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
807162|NCT01370356|E2|Reported Event|Placebo|Placebo was titrated and administered in the same manner as varenicline and reduction of dosing for difficulties with tolerability was also allowed.
807212|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807163|NCT01370356|E1|Reported Event|Varenicline|Varenicline was titrated to the full dose during the first week (Day 1 - 3: 0.5 mg/day; Day 4 -7: 0.5 mg BID). From Week 2 to Week 24, the dose was 1 mg BID. Participants who had difficulties with tolerability were permitted to have the dose lowered temporarily or permanently to 0.5 mg BID.
807164|NCT01370265|B1|Baseline|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
807165|NCT01370265|P2|Participant Flow|Adenosine, Then Regadenoson|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the first intervention period. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered. After a washout period, Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the second intervention period.
807166|NCT01370265|P1|Participant Flow|Regadenoson, Then Adenosine|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush in the first intervention period. Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes in the second intervention period (after washout period). Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807167|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807168|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
807169|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807170|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
807171|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807172|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
807173|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807174|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
807175|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807176|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
807177|NCT01370265|O1|Outcome|Entire Study Population|Includes groups randomized to receive Regadenoson first and Adenosine first.
807178|NCT01370265|O2|Outcome|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807179|NCT01370265|O1|Outcome|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
807180|NCT01370265|E2|Reported Event|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes. Three minutes after the start of adenosine infusion, N-13 ammonia (10-20 mCi) was administered.
807181|NCT01370265|E1|Reported Event|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush and N-13 ammonia (10-20 MCi) injection and an additional saline flush.
807182|NCT01370083|B3|Baseline|Total|Total of all reporting groups
807183|NCT01370083|B2|Baseline|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
807184|NCT01370083|B1|Baseline|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
807205|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807185|NCT01370083|P2|Participant Flow|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
807213|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807214|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807215|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
812377|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
807186|NCT01370083|P1|Participant Flow|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
807187|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
807188|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
807189|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
807190|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
807191|NCT01370083|O2|Outcome|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
807192|NCT01370083|O1|Outcome|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
807193|NCT01370083|E2|Reported Event|Stroke: TPSAT Control|"Individuals with dysphagia (within 4-16 weeks post stroke) who demonstrate difficulties with thin liquid control on videofluoroscopy. Individuals will complete 24 sessions of tongue-pressure strength-and-accuracy training over 8-12 weeks.~Tongue-Pressure Strength-and-Accuracy Training: 60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen."
807194|NCT01370083|E1|Reported Event|Stroke: TPPT|"Adults with dysphagia post stroke (within 4-16 weeks of onset) who have radiographically confirmed difficulties with thin liquid bolus control. Individuals will complete 24 sessions of tongue-pressure-profile training over 8-12 weeks.~Tongue Pressure Profile Training: 60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer."
807195|NCT01370005|B4|Baseline|Total|Total of all reporting groups
807196|NCT01370005|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807197|NCT01370005|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807198|NCT01370005|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807199|NCT01370005|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807200|NCT01370005|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807201|NCT01370005|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807202|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807203|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807204|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807207|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807208|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807209|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807210|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807211|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807216|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807217|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807218|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807219|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807220|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807221|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807222|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807223|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807224|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807225|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807226|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807227|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807228|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807229|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807230|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807231|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807232|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807233|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807234|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807235|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807236|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807237|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807238|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807239|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807240|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807241|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807242|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807243|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807244|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807245|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807246|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807247|NCT01370005|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807248|NCT01370005|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807249|NCT01370005|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807250|NCT01370005|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 12 weeks.
807251|NCT01370005|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 12 weeks.
807252|NCT01370005|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 12 weeks.
807253|NCT01369888|B5|Baseline|Total|Total of all reporting groups
807254|NCT01369888|B4|Baseline|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807290|NCT01369849|E3|Reported Event|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807255|NCT01369888|B3|Baseline|IL-15 Following Young TIL (10.50 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807256|NCT01369888|B2|Baseline|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807293|NCT01369784|B1|Baseline|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807294|NCT01369784|P1|Participant Flow|Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma)|patients with refractory/relapsed diffuse large B-cell lymphoma
807257|NCT01369888|B1|Baseline|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807258|NCT01369888|P4|Participant Flow|IL-15 Following Young TIL (2 mcg)|"2 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807259|NCT01369888|P3|Participant Flow|IL-15 Following Young TIL (1 mcg)|"1 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807260|NCT01369888|P2|Participant Flow|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807261|NCT01369888|P1|Participant Flow|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807262|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807263|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807264|NCT01369888|O2|Outcome|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807265|NCT01369888|O1|Outcome|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807266|NCT01369888|E2|Reported Event|IL-15 Following Young TIL (0.50 mcg)|"0.50 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807267|NCT01369888|E1|Reported Event|IL-15 Following Young TIL (0.25 mcg)|"0.25 mcg/kg/day x 10~Cyclophosphamide: 60 mg/m^2, intravenous (IV) (in the vein) x 2 days~Fludarabine: 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Tumor Infiltrating Lymphocytes: IV over 30 minutes on day 0~IL-15: IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients."
807268|NCT01369875|B3|Baseline|Total|Total of all reporting groups
807269|NCT01369875|B2|Baseline|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807270|NCT01369875|B1|Baseline|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807271|NCT01369875|P2|Participant Flow|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807272|NCT01369875|P1|Participant Flow|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807273|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807274|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807275|NCT01369875|O2|Outcome|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807276|NCT01369875|O1|Outcome|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807277|NCT01369875|E2|Reported Event|ECCE Young TIL|"Tumor Infiltrating Lymphocytes : IV over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day IVPB daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807278|NCT01369875|E1|Reported Event|Standard Young TIL|"Tumor Infiltrating Lymphocytes : intravenous (IV) over 30 minutes on day 0~Aldesleukin : 720,000 IU/kg IV over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)~Fludarabine : 25 mg/m2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days (days -5 to -1)~Cyclophosphamide : 60 mg/kg/day X 2 days IV over 1 hour on days -7 and -6"
807279|NCT01369849|B4|Baseline|Total|Total of all reporting groups
807280|NCT01369849|B3|Baseline|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807281|NCT01369849|B2|Baseline|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807282|NCT01369849|B1|Baseline|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807283|NCT01369849|P3|Participant Flow|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807284|NCT01369849|P2|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807285|NCT01369849|P1|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807286|NCT01369849|O1|Outcome|Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807287|NCT01369849|O3|Outcome|Phase II|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807288|NCT01369849|O2|Outcome|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807289|NCT01369849|O1|Outcome|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807347|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
807348|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
807349|NCT01369745|O5|Outcome|Placebo|placebo once daily
807350|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
807291|NCT01369849|E2|Reported Event|Phase I: Dose Level 2|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 135 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807292|NCT01369849|E1|Reported Event|Phase I: Dose Level 1|"Patients receive:~Cycle 1:~Akt inhibitor MK2206 PO 90 mg on days 1, 8, 15, and 22 (days 1, 8, 15, 22)~Rituximab IV 375 mg/m^2 on day 8.~Bendamustine IV 70 mg/m^2 on day 8 and 9.~Cycles 2-6:~Akt inhibitor MK2206 PO on days 1, 8, 15, and 22 (days 1, 8, 15, 22, and 29)~Rituximab IV 500 mg/m^2 on day 1.~Bendamustine IV 70 mg/m^2 on day 1 and 2."
807295|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807296|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807297|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807298|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807299|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807300|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807301|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807302|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807303|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807304|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807305|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807306|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807307|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807308|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807309|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807310|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807311|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807312|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807313|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807314|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807315|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807316|NCT01369784|O1|Outcome|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807317|NCT01369784|E1|Reported Event|Refractory/Relapsed LDCBG|patients with refractory/relapsed diffuse large B-cell lymphoma
807318|NCT01369745|B6|Baseline|Total|Total of all reporting groups
807319|NCT01369745|B5|Baseline|Placebo|placebo once daily
807320|NCT01369745|B4|Baseline|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily The trial would progress from Stage 3 to Stage 5 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
807321|NCT01369745|B3|Baseline|Prednisone|Prednisone 5 mg once daily The trial would progress from Stage 2 to Stage 4 if the posterior probability that Z102 is superior to prednisolone 2.7 was greater than 0.975.
807322|NCT01369745|B2|Baseline|Dipyridamole|dipyridamole 360 mg once daily The trial would progress from Stage 2 to Stage 3 if the posterior probability that Z102 is superior to dipyridamole was greater than 0.975.
807323|NCT01369745|B1|Baseline|Prednisolone|Prednisolone 2.7 mg once daily The trial would progress from Stage 1 to Stage 2 if the posterior probability that Z102 is superior to placebo was greater than 0.975.
807324|NCT01369745|P5|Participant Flow|Placebo|placebo once daily
807325|NCT01369745|P4|Participant Flow|Z102|2.7 mg prednisolone plus 360 mg dipyridamole once daily
807326|NCT01369745|P3|Participant Flow|Prednisone|Prednisone 5 mg once daily
807327|NCT01369745|P2|Participant Flow|Dipyridamole|dipyridamole 360 mg once daily
807328|NCT01369745|P1|Participant Flow|Prednisolone|Prednisolone 2.7 mg once daily
807329|NCT01369745|O5|Outcome|Placebo|placebo once daily
807330|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
807331|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
807332|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
807333|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
807334|NCT01369745|O5|Outcome|Placebo|placebo once daily
807335|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
807336|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
807337|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
807338|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
807339|NCT01369745|O5|Outcome|Placebo|placebo once daily
807340|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
807341|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
807342|NCT01369745|O2|Outcome|Dipyridamole|dipyridamole 360 mg once daily
807343|NCT01369745|O1|Outcome|Prednisolone|Prednisolone 2.7 mg once daily
807344|NCT01369745|O5|Outcome|Placebo|placebo once daily
807345|NCT01369745|O4|Outcome|Z102|prednisolone 2.7 mg plus dipyridamole 360 mg once daily
807346|NCT01369745|O3|Outcome|Prednisone|Prednisone 5 mg once daily
807358|NCT01369745|E1|Reported Event|Prednisolone|Prednisolone 2.7 mg daily
807359|NCT01369732|B3|Baseline|Total|Total of all reporting groups
807360|NCT01369732|B2|Baseline|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
807361|NCT01369732|B1|Baseline|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
807362|NCT01369732|P2|Participant Flow|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
807363|NCT01369732|P1|Participant Flow|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
807364|NCT01369732|O2|Outcome|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
807365|NCT01369732|O1|Outcome|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
807366|NCT01369732|E2|Reported Event|Erythropoietin Group|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
807367|NCT01369732|E1|Reported Event|Saline Group|We administrate the saline single bolus (5ml, intravenously) 30 min before the commencement of ischemia.
807368|NCT01369706|B1|Baseline|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
807369|NCT01369706|P1|Participant Flow|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
807370|NCT01369706|O1|Outcome|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
807371|NCT01369706|E1|Reported Event|Hand-held Metal Detector|"Exposure to two hand-held metal detectors~Hand-held metal detector: 2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)"
807372|NCT01369680|B5|Baseline|Total|Total of all reporting groups
807373|NCT01369680|B4|Baseline|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
807374|NCT01369680|B3|Baseline|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
807375|NCT01369680|B2|Baseline|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
807376|NCT01369680|B1|Baseline|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
807377|NCT01369680|P4|Participant Flow|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
807378|NCT01369680|P3|Participant Flow|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
807379|NCT01369680|P2|Participant Flow|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
807380|NCT01369680|P1|Participant Flow|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
807381|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine.
807382|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
807383|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine.
807384|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine.
807385|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Subjects treated at 1 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
807386|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Subjects treated at 0.5 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
807387|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Subjects treated at 0.25 mg/kg/dose consenting for separate pharmacokinetics test at week 1 of study.
807388|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
807389|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
807390|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
807391|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine. Measure was for clinically significant decline in neurocognitive scores.
807392|NCT01369680|O4|Outcome|Ketamine 1.5 mg/kg/Dose|Cohort of three subjects administered 1.5 mg/kg/dose oral ketamine
807393|NCT01369680|O3|Outcome|Ketamine 1 mg/kg/Dose|Cohort of three subjects administered 1 mg/kg/dose oral ketamine
807394|NCT01369680|O2|Outcome|Ketamine 0.5 mg/kg/Dose|Cohort of three subjects administered 0.5 mg/kg/dose oral ketamine
807395|NCT01369680|O1|Outcome|Ketamine 0.25 mg/kg/Dose|Cohort of three subjects administered 0.25 mg/kg/dose oral ketamine
807396|NCT01369680|E4|Reported Event|Ketamine 1.5 mg/kg/Dose|Cohort of three participants treated at 1.5 mg/kg/dose oral ketamine.
807397|NCT01369680|E3|Reported Event|Ketamine 1 mg/kg/Dose|Cohort of three participants treated at 1 mg/kg/dose oral ketamine.
807398|NCT01369680|E2|Reported Event|Ketamine 0.5 mg/kg/Dose|Cohort of three participants treated at 0.5 mg/kg/dose oral ketamine.
807399|NCT01369680|E1|Reported Event|Ketamine 0.25 mg/kg/Dose|Cohort of three participants treated at 0.25 mg/kg/dose oral ketamine.
807424|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807449|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807400|NCT01369641|B1|Baseline|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
807427|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807401|NCT01369641|P1|Participant Flow|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
807402|NCT01369641|O1|Outcome|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
807403|NCT01369641|E1|Reported Event|Sodium Thiosulfate (STS) Ear & Placebo Ear|"Subjects enrolled to study will have their ears randomized for treatment with STS. The experimental ear will receive STS treatments, while the comparator ear will receive a placebo.~Insertion of Pressure Equalization (PE) Tubes: If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.~Sodium Thiosulfate (STS): Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.~Cisplatin: Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2"
807404|NCT01369615|B3|Baseline|Total|Total of all reporting groups
807405|NCT01369615|B2|Baseline|≥ 12 to ≤ 16 Years|Children 12 to ≤ 16 years of age
807406|NCT01369615|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
807407|NCT01369615|P2|Participant Flow|≥ 12 to ≤ 16 Years|Although the protocol for study OTR3002 defined the age range as 6 to 17 years inclusive, no patients greater than 16 years of age were included in the study. Therefore the data summaries presented the upper limit of the older age group as ≤ 16 years.
807408|NCT01369615|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
807409|NCT01369615|O2|Outcome|≥ 12 to ≤ 16 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
807410|NCT01369615|O1|Outcome|6 to < 12 Years|Test treatment: open-label oxycodone HCl CR tablets, 20 mg to 240 mg total daily
807411|NCT01369615|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
807412|NCT01369615|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
807413|NCT01369485|B3|Baseline|Total|Total of all reporting groups
807414|NCT01369485|B2|Baseline|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807415|NCT01369485|B1|Baseline|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807416|NCT01369485|P2|Participant Flow|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
807417|NCT01369485|P1|Participant Flow|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.~Patients completing ther randomized phase of the study were rolled over to receive active treatment with VERV™ System for up to 9 additional months."
807418|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807419|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807420|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807421|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807422|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807423|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807425|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807426|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807428|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807429|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807430|NCT01369485|O4|Outcome|Open Label Sham Treatement Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807431|NCT01369485|O3|Outcome|Open Label Active Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807432|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807433|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807434|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807435|NCT01369485|O3|Outcome|Open Label Active Treatment Group.|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807436|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807437|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807438|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807439|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807440|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807441|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807442|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807443|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807444|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807445|NCT01369485|O3|Outcome|Open Label Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807446|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807447|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807448|NCT01369485|O4|Outcome|Open Label Sham Treatment Group|Patients received active treatment with the VERV™ System for up to 9 additional months as part of the open label phase of the study.
807450|NCT01369485|O2|Outcome|Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807451|NCT01369485|O1|Outcome|Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807452|NCT01369485|E4|Reported Event|Open Label Sham Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
807508|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807453|NCT01369485|E3|Reported Event|Open Label Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for up to 9 additional months, one per week during the open label phase."
807454|NCT01369485|E2|Reported Event|Randomized Sham Treatment Group|"Sham version of (VERV™ System)~Sham version of (VERV™ System): Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807455|NCT01369485|E1|Reported Event|Randomized Active Treatment Group|"VERV™ System~(VERV™ System): Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete."
807456|NCT01369355|B7|Baseline|Total|Total of all reporting groups
807457|NCT01369355|B6|Baseline|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).
807458|NCT01369355|B5|Baseline|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
807459|NCT01369355|B4|Baseline|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
807460|NCT01369355|B3|Baseline|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
807461|NCT01369355|B2|Baseline|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
807462|NCT01369355|B1|Baseline|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
807463|NCT01369355|P6|Participant Flow|UST-I-nonRsp - UST-90mg Subcutaneously (SC) Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response).
807464|NCT01369355|P5|Participant Flow|PBO-I-nonRsp - UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response).
807465|NCT01369355|P4|Participant Flow|Placebo (PBO)-I-Rsp - PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC q4w in the maintenance study.
807466|NCT01369355|P3|Participant Flow|UST-I-Rsp-UST-90 mg Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
807467|NCT01369355|P2|Participant Flow|UST-I-Rsp-UST-90 mg Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study.
807468|NCT01369355|P1|Participant Flow|Ustekinumab Induction Responders(UST-I-Rsp)Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
807469|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
807470|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
807471|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
807472|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
807473|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
807474|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
807475|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
807476|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
807839|NCT01368406|P2|Participant Flow|Treatment as Usual|treatment as usual received by the patients
807477|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
807478|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
807479|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
812616|NCT01351506|B1|Baseline|ICU Survivors|Patients who survivors from ICU discharge status
807480|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
807481|NCT01369355|O3|Outcome|Ustekinumab 90 mg SC q8w|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q8w in the maintenance study.
807482|NCT01369355|O2|Outcome|Ustekinumab 90 Milligram (mg) SC Every 12 Weeks (q12w)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive Ustekinumab SC 90 mg q12w in the maintenance study.
807483|NCT01369355|O1|Outcome|Placebo Subcutaneously (SC)|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) randomized to receive placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study.
807484|NCT01369355|E9|Reported Event|UST IV-I-nonRsp - UST-90 mg SC Q8W Maintenance|Participants (who were not in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab 90 mg SC on entry into maintenance followed by Ustekinumab 90 mg SC q8w beginning at Week 8 of maintenance (if in response); not randomized.
807485|NCT01369355|E8|Reported Event|PBO-I-nonRsp- UST-130mg Intravenous/90mg SC Q12W Maintenance|Participants (who were not in clinical response to placebo IV at Week 8 of an induction study) received Ustekinumab 130 mg IV on entry into maintenance followed by Ustekinumab 90 mg SC q12 weeks beginning at Week 8 of maintenance (if in response); not randomized.
807486|NCT01369355|E7|Reported Event|Placebo (PBO)-I-Rsp PBO Maintenance|Participants (who were in clinical response to placebo IV at Week 8 of an induction study) received placebo SC; not randomized.
807487|NCT01369355|E6|Reported Event|UST IV-I-Rsp-UST-90mg Maintenance-UST-90mg SC Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q8 weeks and remained on ustekinumab 90 mg q8w upon loss of response (includes events from the time of loss of response onward).
807488|NCT01369355|E5|Reported Event|UST-I-Rsp-UST 90 mg SC Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q8w (includes events up to the time of loss of response).
807489|NCT01369355|E4|Reported Event|UST-I-Rsp-UST 90 mg SC Q12W/Q8W Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 mg q12w and had dose adjustment to Ustekinumab SC 90 mg q8w in the maintenance study (includes events from the time of loss of response onward).
807490|NCT01369355|E3|Reported Event|UST-I-Rsp-UST 90 mg SC Every 12 Weeks (Q12W) Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received Ustekinumab SC 90 milligrams (mg) q12w in the maintenance study (includes events up to the time of loss of response).
807491|NCT01369355|E2|Reported Event|UST -I-Rsp -PBO Maintenance -UST-90mg SC Q8W- Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo SC and had dose adjustment to Ustekinumab SC 90 mg q8w (includes events from the time of loss of response onward).
807492|NCT01369355|E1|Reported Event|Ustekinumab Induction Responders(USTIRsp) Placebo Maintenance|Participants (who were in clinical response to Ustekinumab IV at Week 8 of an induction study) received placebo subcutaneously (SC) every 4 weeks (q4w) in the maintenance study (includes events up to the time of loss of response).
807493|NCT01369342|B4|Baseline|Total|Total of all reporting groups
807494|NCT01369342|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807495|NCT01369342|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807496|NCT01369342|B1|Baseline|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807497|NCT01369342|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807498|NCT01369342|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807499|NCT01369342|P1|Participant Flow|Placebo IV|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807500|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807501|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807502|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807503|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807504|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807505|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807506|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807507|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
813075|NCT01350115|B1|Baseline|LDE225|Participants received 400 mg once daily.
807509|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807510|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807511|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807512|NCT01369342|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807513|NCT01369342|O2|Outcome|Ustekinumab 130 mg|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807514|NCT01369342|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807515|NCT01369342|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received a single tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807516|NCT01369342|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received single dose of ustekinumab 130 milligram (mg) IV at week 0.
807517|NCT01369342|E1|Reported Event|Placebo IV|Participants received single dose of Placebo Intravenous (IV) infusion at week 0.
807518|NCT01369329|B4|Baseline|Total|Total of all reporting groups
807519|NCT01369329|B3|Baseline|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807520|NCT01369329|B2|Baseline|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807521|NCT01369329|B1|Baseline|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807522|NCT01369329|P3|Participant Flow|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807523|NCT01369329|P2|Participant Flow|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807524|NCT01369329|P1|Participant Flow|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807525|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807526|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807527|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807528|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807529|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807530|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807531|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807532|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807533|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807534|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807535|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807536|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807667|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
807537|NCT01369329|O3|Outcome|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants randomized to receive tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807538|NCT01369329|O2|Outcome|Ustekinumab 130 Milligram (mg)|Participants randomized to receive a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807539|NCT01369329|O1|Outcome|Placebo|Participants randomized to receive a single dose of Placebo Intravenous (IV) infusion at week 0.
807676|NCT01368874|P2|Participant Flow|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
807540|NCT01369329|E3|Reported Event|Ustekinumab Approximately (~) 6 Milligram Per Kilogram (mg/kg)|Participants received tiered ustekinumab dose approximately (~) 6 mg/kg IV at week 0. Ustekinumab 260 mg for participants body weight less than or equal to (< =) 55 kg, ustekinumab 390 mg for weight greater than (>) 55 kg and < = 85 kg and ustekinumab 520 mg for weight > 85 kg.
807541|NCT01369329|E2|Reported Event|Ustekinumab 130 Milligram (mg)|Participants received a single dose of ustekinumab 130 milligram (mg) IV at week 0.
807542|NCT01369329|E1|Reported Event|Placebo|Participants received a single dose of Placebo Intravenous (IV) infusion at week 0.
807543|NCT01369225|B7|Baseline|Total|Total of all reporting groups
807544|NCT01369225|B6|Baseline|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807545|NCT01369225|B5|Baseline|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807546|NCT01369225|B4|Baseline|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807547|NCT01369225|B3|Baseline|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807548|NCT01369225|B2|Baseline|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807549|NCT01369225|B1|Baseline|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807550|NCT01369225|P6|Participant Flow|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807551|NCT01369225|P5|Participant Flow|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807552|NCT01369225|P4|Participant Flow|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807553|NCT01369225|P3|Participant Flow|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807554|NCT01369225|P2|Participant Flow|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807555|NCT01369225|P1|Participant Flow|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807556|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807557|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807558|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807559|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807560|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807561|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807562|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807563|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807564|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807565|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807566|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807567|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807668|NCT01368900|O1|Outcome|Subjects Treated|All study subject received an Ulthera treatment to the upper face.
807568|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807569|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807570|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807571|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807572|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807573|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807574|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807575|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807576|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807577|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807578|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807579|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807580|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807581|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807582|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807583|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807584|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807585|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807586|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807587|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807588|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807589|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807590|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807591|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807592|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807593|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807594|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807595|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807596|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807597|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807669|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
807598|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807599|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807600|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807601|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807602|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807603|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807604|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807605|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807606|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807607|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807608|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807609|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807610|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807611|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807612|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807613|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807614|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807615|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807616|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807617|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807618|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807619|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807620|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807621|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807622|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807623|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807624|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807625|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807626|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807627|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807670|NCT01368900|E1|Reported Event|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
807671|NCT01368874|B4|Baseline|Total|Total of all reporting groups
807628|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807629|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807630|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807631|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807632|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807633|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807634|NCT01369225|O6|Outcome|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807635|NCT01369225|O5|Outcome|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807636|NCT01369225|O4|Outcome|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807637|NCT01369225|O3|Outcome|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807638|NCT01369225|O2|Outcome|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807639|NCT01369225|O1|Outcome|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807640|NCT01369225|E6|Reported Event|Placebo/AAB-003|Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
807641|NCT01369225|E5|Reported Event|AAB-003 8 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
807642|NCT01369225|E4|Reported Event|AAB-003 4 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
807643|NCT01369225|E3|Reported Event|AAB-003 2 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
807644|NCT01369225|E2|Reported Event|AAB-003 1 mg/kg|Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
807645|NCT01369225|E1|Reported Event|AAB-003 0.5 mg/kg|Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
807646|NCT01369030|B1|Baseline|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
807647|NCT01369030|P1|Participant Flow|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
807648|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
807649|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
807650|NCT01369030|O1|Outcome|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
807651|NCT01369030|E1|Reported Event|Deplin®|Subjects with depression who have been prescribed Deplin® daily.
807652|NCT01368965|B1|Baseline|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
807653|NCT01368965|P1|Participant Flow|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
807654|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52).
807655|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
807656|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
807657|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
807658|NCT01368965|O1|Outcome|Treated Subjects|Study subjects who received a full face Ulthera treatment. (n=52)
807659|NCT01368965|O1|Outcome|Treated Subjects|All treated study subjects received a full face Ulthera® treatment.
807660|NCT01368965|E1|Reported Event|Enrolled Subjects|Includes all subjects enrolled, including 52 treated subjects and 2 non-treated subjects who withdrew consent prior to treatment.
807661|NCT01368900|B1|Baseline|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
807662|NCT01368900|P1|Participant Flow|Treated Subjects|"The FWCS, a 9 point scale used to classify wrinkle severity, was used to qualify subjects for study participation.~Score 1-3 = Fine wrinkles; 4-6 = Fine to moderate-depth wrinkles, moderate number of lines; 7-9 = Fine to deep wrinkles, Numerous lines with or without redundant skin folds.~All study subjects received an Ulthera treatment to the upper face."
807663|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
807664|NCT01368900|O1|Outcome|Treated Subjects|All study subjects received an Ulthera treatment to the upper face.
807665|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
807666|NCT01368900|O1|Outcome|Subjects Treated|All study subjects received an Ulthera treatment to the upper face.
807672|NCT01368874|B3|Baseline|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
807673|NCT01368874|B2|Baseline|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
807674|NCT01368874|B1|Baseline|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
807675|NCT01368874|P3|Participant Flow|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
807677|NCT01368874|P1|Participant Flow|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
807678|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
807679|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
807680|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
807681|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region.
807682|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 180 day post-treatment visit.
807683|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
807684|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
807685|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
807686|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
807687|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 90 day post-treatment visit.
807688|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
807689|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
807690|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
807691|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
807692|NCT01368874|O1|Outcome|All Subjects Treated|Treated subjects completing a 60 day post-treatment visit.
807693|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
807694|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
807695|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 180-day study visit.
807696|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
807697|NCT01368874|O1|Outcome|All Subjects Treated|Sixty (60) of 64 treated participants completed the 180-day study visit.
807698|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
807699|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 90-day study visit.
807700|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
807701|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
807702|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
807703|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 180-day study visit.
807704|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) participants completed the 180-day study visit.
807705|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the study visit.
807706|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 180-day study visit.
807707|NCT01368874|O1|Outcome|All Subjects Treated|Sixty(60) of 64 treated participants completed the 180-day study visit.
807708|NCT01368874|O4|Outcome|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
811230|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
807709|NCT01368874|O3|Outcome|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
807710|NCT01368874|O2|Outcome|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
807711|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-four 64) treated participants' assessment of pain was completed during the Ulthera® treatment.
807712|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular, and lower neck regions.
807713|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions.
807714|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental,submandibular,and lower neck regions.
807715|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region.
807716|NCT01368874|O1|Outcome|All Subjects Treated|A data set of 42 of the 61 participants were re-analyzed. Data were removed for 19 participants whose pre-treatment and/or post-treatment photos were of poor photo quality, i.e., poor lighting, poor focus, poor positioning, creating the potential for biasing the masked assessment results.
807717|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Twenty-nine (29) participants completed the 90-day study visit.
807718|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four(24) participants completed the 90-day study visit.
807719|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 90-day study visit.
807720|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) participants completed the 90-day study visit.
807721|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit.
807722|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions. Thirty (30) participants completed the 60-day study visit.
807723|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-five (25) participants completed the 60-day study visit.
807724|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face,submental, submandibular, and lower neck regions. Five participants completed the 60-day study visit.
807725|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy®® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-one (31) participants completed the 60-day study visit.
807726|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 60- visit.
807727|NCT01368874|O5|Outcome|Groups B/C|Combined participants from Groups B and C that received dual depth Ultherapy® treatment over all regions treated, i.e., platysmal muscle above the jawline, and submental, submandibular and lower neck regions.
807728|NCT01368874|O4|Outcome|Group C|Participants that received dual depth Ultherapy® treatment on the submental, submandibular and lower neck regions. Twenty-four (24) of 25 participants completed the 90-day study visit; 1 participant was lost-to-follow-up
807729|NCT01368874|O3|Outcome|Group B|Participants that received dual depth Ultherapy® treatment on the lower face, submental, submandibular, and lower neck regions.
807730|NCT01368874|O2|Outcome|Group A|Participants that received dual depth Ultherapy® treatment on the submental and submandibular regions, and single-depth treatment to the lower neck region. Thirty-two (32) of 34 Group A participants completed the 90-day study visit; two participants were lost-to-follow-up.
807731|NCT01368874|O1|Outcome|All Subjects Treated|Sixty-one (61) of 64 treated participants completed the 90-day study visit; 2 participants (1 each from Groups A and C)were lost-to-follow-up, 1 participant(Group A) missed the visit.
807732|NCT01368874|E4|Reported Event|Groups B/C|
807733|NCT01368874|E3|Reported Event|Group C|Dual depth treatment on the submental, submandibular and lower neck regions.
807734|NCT01368874|E2|Reported Event|Group B|Dual depth treatment of the platysmal muscle above the jawline, as well as dual depth treatment on the submental, submandibular and lower neck regions.
807735|NCT01368874|E1|Reported Event|Group A|Dual depth treatment on the submental and submandibular regions and single-depth treatment to the lower neck region
807736|NCT01368835|B1|Baseline|Ulthera Treatment|Treatment to the lower face and submental region.
807737|NCT01368835|P1|Participant Flow|Ulthera Treatment|Subjects will receive one dual-depth focused ultrasound treatment to their lower face and submental regions.
807738|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
807739|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
807740|NCT01368835|O1|Outcome|Ulthera Treatment|Treatment to the lower face and submental region.
807741|NCT01368835|O1|Outcome|Ulthera Treatment|Subjects who received one focused ultrasound treatment to the lower face and submental regions using the Ultera System.
807742|NCT01368835|E1|Reported Event|Ulthera Treatment|Treatment to the lower face and submental region.
807743|NCT01368809|B3|Baseline|Total|Total of all reporting groups
807744|NCT01368809|B2|Baseline|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
807745|NCT01368809|B1|Baseline|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
807746|NCT01368809|P2|Participant Flow|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
807747|NCT01368809|P1|Participant Flow|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
807748|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
807749|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
807750|NCT01368809|O2|Outcome|Saline Solution|Saline Solution 2 ml at induction, 1-2 ml boluses as needed
807751|NCT01368809|O1|Outcome|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
807752|NCT01368809|O2|Outcome|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
807753|NCT01368809|O1|Outcome|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
807754|NCT01368809|E2|Reported Event|Saline Solution|"Saline Solution 2 ml at induction, 1-2 ml boluses as needed~Fentanyl: Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed"
807755|NCT01368809|E1|Reported Event|Fentanyl|"Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed~Saline: 2 ml at induction 1-2 ml boluses as needed"
807756|NCT01368653|B3|Baseline|Total|Total of all reporting groups
807757|NCT01368653|B2|Baseline|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
807758|NCT01368653|B1|Baseline|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
807759|NCT01368653|P2|Participant Flow|Standard Treatment+Practice Quitting|"In this arm, participants receive standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
807760|NCT01368653|P1|Participant Flow|Standard Treatment|"In this arm, smokers receive a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
807761|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
807762|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
807763|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
807764|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
807765|NCT01368653|O4|Outcome|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
807779|NCT01368536|P3|Participant Flow|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807838|NCT01368406|B1|Baseline|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
807766|NCT01368653|O3|Outcome|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
807767|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
807768|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
807769|NCT01368653|O2|Outcome|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involved practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
807770|NCT01368653|O1|Outcome|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
807771|NCT01368653|E4|Reported Event|Advice and Encouragement Only|Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a very-low-nicotine-cigarette condition (n=20) at the 4-week follow-up. In this control condition, smokers received advice and encouragement to try to stop smoking again at the 4-week follow-up after they slipped (returned to smoking) during a stop smoking attempt.
807772|NCT01368653|E3|Reported Event|Very Low Nicotine Cigarettes|"Smokers who had smoked in the last 7 days at the 4-week telephone follow-up interview (N=40) were randomly assigned to either this condition (n=20) or a smoking cessation advice and encouragement control condition (n=20) at the 4-week follow-up. In this condition, smokers received a 6-week supply of cigarettes that contained tobacco with very low levels of nicotine (in regular or menthol flavors) to smoke instead of regular cigarettes containing nicotine. This treatment was designed to help people stop smoking after slipping (returning to smoking) during an attempt to stop smoking~Very low nicotine cigarettes: Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These were to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks."
807773|NCT01368653|E2|Reported Event|Standard Treatment+Practice Quitting|"In this arm, participants received standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling.~Standard treatment+practice quitting: This intervention included standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling"
807774|NCT01368653|E1|Reported Event|Standard Treatment|"In this arm, smokers received a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help them quit smoking~Standard treatment: Standard treatment included a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking"
807775|NCT01368536|B4|Baseline|Total|Total of all reporting groups
807776|NCT01368536|B3|Baseline|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807777|NCT01368536|B2|Baseline|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807778|NCT01368536|B1|Baseline|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807833|NCT01368432|O1|Outcome|Placebo Group Baseline|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
807834|NCT01368432|E2|Reported Event|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week.
807780|NCT01368536|P2|Participant Flow|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807781|NCT01368536|P1|Participant Flow|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807782|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807783|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807784|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807785|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807786|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807787|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807788|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807789|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807790|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807791|NCT01368536|O3|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807792|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807793|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807794|NCT01368536|O2|Outcome|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807795|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807835|NCT01368432|E1|Reported Event|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
807836|NCT01368406|B3|Baseline|Total|Total of all reporting groups
807837|NCT01368406|B2|Baseline|Treatment as Usual|treatment as usual received by the patients
807796|NCT01368536|O2|Outcome|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807797|NCT01368536|O1|Outcome|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807798|NCT01368536|E3|Reported Event|Valturna + Chlorthalidone|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 15 mg chlorthalidone for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 25 mg chlorthalidonefor 4 weeks.
807799|NCT01368536|E2|Reported Event|Valturna + Amlodipine|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule 5 mg amlodipine for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule 10 mg amlodipine for 4 weeks.
807800|NCT01368536|E1|Reported Event|Valturna|At double-blind randomization, all patients received 1 tablet Valturna 150/160 mg + 1 tablet Placebo Valturna+ 1 capsule placebo for 2 weeks. From Week 2, patients received 1 tablet Valturna 150/160 mg, + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 6 weeks. From Week 8, patients received 1 tablet Valturna 150/160 mg + 1 tablet Valturna 150/160 mg + 1 capsule placebo for 4 weeks.
807801|NCT01368432|B3|Baseline|Total|Total of all reporting groups
807802|NCT01368432|B2|Baseline|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
807803|NCT01368432|B1|Baseline|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
807804|NCT01368432|P2|Participant Flow|Escitalopram|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
807805|NCT01368432|P1|Participant Flow|Placebo|The placebo group received a pill which appeared similar to the 10 and 20 mg of escitalopram.
807806|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
807807|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
807808|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
807809|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
807810|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
807811|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
807812|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
807813|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
807814|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
807815|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
807816|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
807817|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
807818|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention.
807819|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention.
807820|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention.
807821|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention.
807822|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram intervention and represents their anxiety score.
807823|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their anxiety score.
807824|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram intervention and represents their anxiety score.
807825|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their anxiety score.
807826|NCT01368432|O2|Outcome|Treatment Group 12 Weeks|This group consists of participants who received escitalopram and represents their global health at 12 weeks.
807827|NCT01368432|O1|Outcome|Placebo Group 12 Weeks|This group consists of participants who received the placebo intervention and represents their global health score at 12 weeks
807828|NCT01368432|O2|Outcome|Treatment Group Baseline|This group consists of participants who received escitalopram and represents their baseline global health
807829|NCT01368432|O1|Outcome|Placebo Group Baseline|This group consists of participants who received the placebo intervention and represents their baseline global health.
807830|NCT01368432|O2|Outcome|Treatment Group MADRS 12 Weeks|This group consists of participants who received escitalopram and their level of depression as assessed by the MADRS scoring system.
807831|NCT01368432|O1|Outcome|Placebo Group MADRS 12 Weeks|This group consists of participants who received the placebo intervention and their level of depression as assessed by the MADRS scoring system.
807832|NCT01368432|O2|Outcome|Treatment Group Baseline|Escitalopram was started at 10 mg per day and increased to 20 mg if deemed clinically necessary, at week 4. No medication changes were made after week 8.
807840|NCT01368406|P1|Participant Flow|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
807841|NCT01368406|O2|Outcome|Treatment as Usual|treatment as usual received by the patients
807842|NCT01368406|O1|Outcome|Wellness Program|lifestyle intervention for 12 weeks
807843|NCT01368406|E2|Reported Event|Treatment as Usual|treatment as usual received by the patients
807902|NCT01368081|B13|Baseline|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807844|NCT01368406|E1|Reported Event|Wellness Program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
807845|NCT01368276|B3|Baseline|Total|Total of all reporting groups
807846|NCT01368276|B2|Baseline|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807847|NCT01368276|B1|Baseline|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807848|NCT01368276|P2|Participant Flow|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ plaque forming units (PFU)/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807849|NCT01368276|P1|Participant Flow|GM-CSF|Granulocyte macrophage colony-stimulating factor (GM-CSF) was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807850|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807851|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807852|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807853|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807854|NCT01368276|O2|Outcome|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807855|NCT01368276|O1|Outcome|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807856|NCT01368276|E2|Reported Event|Talimogene Laherparepvec|Talimogene laherparepvec was administered at a concentration of 10⁸ PFU/mL injected into 1 or more skin or subcutaneous tumors on Days 1 and 15 of each 28-day cycle for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807898|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
809189|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
807857|NCT01368276|E1|Reported Event|GM-CSF|GM-CSF was administered at a dose of 125 μg/m²/day subcutaneously for 14 consecutive days followed by 14 days of rest, in 28-day treatment cycles for up to 12 months or until a complete response, occurrence of an unacceptable toxicity, death or another criterion for withdrawal from treatment was met. Participants who demonstrated a partial response after being on treatment for 12 months could continue to be treated until disease progression or another treatment discontinuation criterion was met.
807858|NCT01368263|B4|Baseline|Total|Total of all reporting groups
807859|NCT01368263|B3|Baseline|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807860|NCT01368263|B2|Baseline|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807861|NCT01368263|B1|Baseline|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807862|NCT01368263|P3|Participant Flow|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807863|NCT01368263|P2|Participant Flow|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807864|NCT01368263|P1|Participant Flow|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807865|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807866|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807867|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807868|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807869|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807870|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807871|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807872|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807873|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807874|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807903|NCT01368081|B12|Baseline|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807875|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807876|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807877|NCT01368263|O3|Outcome|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807878|NCT01368263|O2|Outcome|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807879|NCT01368263|O1|Outcome|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807880|NCT01368263|E3|Reported Event|Group 3 (E2 > 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant therapy at the discretion of the physician. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807881|NCT01368263|E2|Reported Event|Group 2 (Ki67 >= 10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Patients receive standard neoadjuvant chemotherapy in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Postsurgical treatment at physician discretion.
807882|NCT01368263|E1|Reported Event|Group 1 (Ki67 <10%, E2 <= 15 pg/ml)|Patients receive 1 cycle (28 days) of endocrine therapy consisting of goserelin acetate SC on day 1 and letrozole or anastrozole PO QD. Neoadjuvant treatment repeats every 28 days for a total of 16-18 weeks in the absence of disease progression or unacceptable toxicity. Patients then undergo the appropriate standard surgical procedure to remove the cancer. Recommendations for postsurgical treatment will be based on PEPI score and physician discretion.
807883|NCT01368211|B3|Baseline|Total|Total of all reporting groups
807884|NCT01368211|B2|Baseline|Reference First, Then Mirasol|"This study arm will receive first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
807885|NCT01368211|B1|Baseline|Mirasol First, Then Reference|"This study arm will receive first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
807886|NCT01368211|P2|Participant Flow|Reference First, Then Mirasol|"This study arm received first a reference untreated 2-4-day-old platelet transfusion and then a Mirasol treated 2-4-day-old platelet transfusion (Reference-Mirasol sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
807887|NCT01368211|P1|Participant Flow|Mirasol First, Then Reference|"This study arm received first a Mirasol treated 2-4-day-old platelet transfusion and then a reference 2-4-day-old platelet transfusion (Mirasol-Reference sequence).~Mirasol-treated Platelets: Mirasol-treated platelet units with:~Platelet yield between 2.4x10e11 and 4.5x10e11~Plasma carryover of >32%~Cell count > 800x103/µL"
807888|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
807889|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
807890|NCT01368211|O2|Outcome|Untreated Reference|Untreated 2-4-day old platelet transfusion
807891|NCT01368211|O1|Outcome|Mirasol|Mirasol-treated 2-4-day old platelet transfusion
807892|NCT01368211|E2|Reported Event|Untreated Reference Platelets|Patients that received an untreated reference2-4-day-old platelet transfusion.
807893|NCT01368211|E1|Reported Event|Mirasol-treated Platelets|Patients that received a Mirasol treated 2-4-day-old platelet transfusion.
807894|NCT01368185|B1|Baseline|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
807895|NCT01368185|P1|Participant Flow|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
807896|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
807897|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
807899|NCT01368185|O1|Outcome|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
807900|NCT01368185|E1|Reported Event|All Participants|Participants with hypertension who had been treated with MK-0954A (losartan potassium 50 mg + hydrochlorothiazide 12.5 mg) for at least three months
807901|NCT01368081|B14|Baseline|Total|Total of all reporting groups
807904|NCT01368081|B11|Baseline|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807905|NCT01368081|B10|Baseline|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807906|NCT01368081|B9|Baseline|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807907|NCT01368081|B8|Baseline|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807908|NCT01368081|B7|Baseline|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807909|NCT01368081|B6|Baseline|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807910|NCT01368081|B5|Baseline|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807911|NCT01368081|B4|Baseline|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807912|NCT01368081|B3|Baseline|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
807913|NCT01368081|B2|Baseline|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807914|NCT01368081|B1|Baseline|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807915|NCT01368081|P13|Participant Flow|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807916|NCT01368081|P12|Participant Flow|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807917|NCT01368081|P11|Participant Flow|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
807918|NCT01368081|P10|Participant Flow|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of dipeptidyl peptidase IV (DPP−IV) inhibitor
807919|NCT01368081|P9|Participant Flow|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807920|NCT01368081|P8|Participant Flow|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807921|NCT01368081|P7|Participant Flow|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807922|NCT01368081|P6|Participant Flow|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807923|NCT01368081|P5|Participant Flow|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807924|NCT01368081|P4|Participant Flow|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807925|NCT01368081|P3|Participant Flow|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
807926|NCT01368081|P2|Participant Flow|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807927|NCT01368081|P1|Participant Flow|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807928|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807929|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807930|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807931|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807932|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807933|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807934|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807935|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807936|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807937|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
811492|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
807938|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
807939|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807940|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807941|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807942|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807943|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807944|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807945|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807946|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807947|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807948|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807949|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807950|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807951|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
807952|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807953|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807954|NCT01368081|O13|Outcome|Glinide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807955|NCT01368081|O12|Outcome|Glinide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807956|NCT01368081|O11|Outcome|DPP−IV Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807957|NCT01368081|O10|Outcome|DPP−IV Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP−IV inhibitor
807958|NCT01368081|O9|Outcome|Alpha Glucosidase Inhibitor: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807959|NCT01368081|O8|Outcome|Alpha Glucosidase Inhibitor: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha glucosidase inhibitor
807960|NCT01368081|O7|Outcome|Thiazolidinedione: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807961|NCT01368081|O6|Outcome|Thiazolidinedione: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807962|NCT01368081|O5|Outcome|Biguanide: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807963|NCT01368081|O4|Outcome|Biguanide: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807964|NCT01368081|O3|Outcome|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
807965|NCT01368081|O2|Outcome|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807966|NCT01368081|O1|Outcome|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807967|NCT01368081|E13|Reported Event|Glinide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
807968|NCT01368081|E12|Reported Event|Glinide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Glinide
809190|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
807969|NCT01368081|E11|Reported Event|DPP-4 Inhibitor: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
807970|NCT01368081|E10|Reported Event|DPP-4 Inhibitor: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of DPP-4 inhibitor
807971|NCT01368081|E9|Reported Event|Alpha-GI: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
807972|NCT01368081|E8|Reported Event|Alpha-GI: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Alpha-GI
807973|NCT01368081|E7|Reported Event|Thiazolidinedione: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807974|NCT01368081|E6|Reported Event|Thiazolidinedione: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Thiazolidinedione
807975|NCT01368081|E5|Reported Event|Biguanide: Empa 25mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807976|NCT01368081|E4|Reported Event|Biguanide: Empa 10mg|tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Biguanide
807977|NCT01368081|E3|Reported Event|Sulfonylurea: Metformin|250mg tablet of metformin twice daily for 52 weeks, as an open-label treatment, for patients with background treatment of Sulfonylurea
807978|NCT01368081|E2|Reported Event|Sulfonylurea: Empa 25mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807979|NCT01368081|E1|Reported Event|Sulfonylurea: Empa 10mg|One tablet of empagliflozin (empa) once daily for 52 weeks as an add-on therapy for patients with a background treatment of Sulfonylurea
807980|NCT01368042|B1|Baseline|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807981|NCT01368042|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807982|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807983|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807984|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807985|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807986|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807987|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807988|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807989|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807990|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807991|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807992|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807993|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807994|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807995|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807996|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807997|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807998|NCT01368042|O1|Outcome|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible participants treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
807999|NCT01368042|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperpathyroidism|All eligible patients treated with paricalcitol iv according to the approved Summary of Product Characteristics (SmPC)
808000|NCT01367886|B1|Baseline|Fesoterodine|Overactive bladder subjects took Fesoterodine 4 mg daily for 6 weeks.
808001|NCT01367886|P1|Participant Flow|Fesoterodine|"Females with overactive bladder symptoms were given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
808002|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
808003|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine: Fesoterodine 4 mg. tablet by mouth daily for six weeks"
808004|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
808005|NCT01367886|O1|Outcome|Fesoterodine|"Females with overactive bladder symptoms will be given fesoterodine 4 mg. daily for six weeks.~fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
808006|NCT01367886|E1|Reported Event|Fesoterodine|"Females with overactive bladder symptoms will be given Fesoterodine 4 mg. daily for six weeks.~Fesoterodine : Fesoterodine 4 mg. tablet by mouth daily for six weeks"
808007|NCT01367860|B3|Baseline|Total|Total of all reporting groups
812313|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
808008|NCT01367860|B2|Baseline|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808009|NCT01367860|B1|Baseline|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808010|NCT01367860|P2|Participant Flow|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808011|NCT01367860|P1|Participant Flow|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808012|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808013|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808014|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808015|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808016|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808017|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808018|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808090|NCT01367665|P1|Participant Flow|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
808019|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
812314|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
808020|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808021|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808022|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808023|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808024|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808025|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808026|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808027|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808028|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808029|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808030|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808031|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808032|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808033|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808034|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808035|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808036|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808037|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808038|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808039|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808040|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808041|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808042|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808043|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808044|NCT01367860|O2|Outcome|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808045|NCT01367860|O1|Outcome|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808046|NCT01367860|E2|Reported Event|SJet|"This group will be formed by randomization, and receive the discectomy procedure addressed by the technique of Percutaneous Diskectomy SpineJet~Percutaneous Diskectomy SpineJet : Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy."
808047|NCT01367860|E1|Reported Event|OMicro|"This group will be formed by randomization, which gets out surgery to open microdiscectomy~Open microdiscectomy : The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision."
808048|NCT01367834|B3|Baseline|Total|Total of all reporting groups
808049|NCT01367834|B2|Baseline|Control|Subjects will receive no GH or placebo.
808050|NCT01367834|B1|Baseline|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
808051|NCT01367834|P2|Participant Flow|Control|Subjects will receive no GH or placebo.
808052|NCT01367834|P1|Participant Flow|Growth Hormone|"Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
808053|NCT01367834|O2|Outcome|Control|No intervention
808054|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808055|NCT01367834|O2|Outcome|Control|No intervention
808056|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808057|NCT01367834|O2|Outcome|Control|No intervention
808058|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808059|NCT01367834|O2|Outcome|Control|No intervention
808060|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808061|NCT01367834|O2|Outcome|Control|No intervention
808062|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808063|NCT01367834|O2|Outcome|Control|No intervention
808064|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808065|NCT01367834|O2|Outcome|Control|No intervention
808066|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808067|NCT01367834|O2|Outcome|Control|No intervention
808068|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808069|NCT01367834|O2|Outcome|Control|No intervention
808070|NCT01367834|O1|Outcome|Growth Hormone|Subjects in the growth hormone (GH) arm will receive GH injections from 12-24 months of life.
808071|NCT01367834|E2|Reported Event|Control|Subjects will receive no GH or placebo.
808072|NCT01367834|E1|Reported Event|Growth Hormone|"Subjects in the somatotropin (growth hormone, GH) arm will receive GH injections from 12-24 months of life.~somatotropin: Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life."
808073|NCT01367704|B3|Baseline|Total|Total of all reporting groups
808074|NCT01367704|B2|Baseline|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808075|NCT01367704|B1|Baseline|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
808091|NCT01367665|O2|Outcome|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
808154|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808092|NCT01367665|O1|Outcome|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
809376|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
808076|NCT01367704|P2|Participant Flow|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808077|NCT01367704|P1|Participant Flow|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
808078|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808079|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808080|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808081|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808082|NCT01367704|O2|Outcome|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808083|NCT01367704|O1|Outcome|Control School|"Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808084|NCT01367704|E2|Reported Event|Intervention School|"Intervention schools (where coaches receive the CBIM training at start of sports season)~Coaching Boys Into Men program: Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
808085|NCT01367704|E1|Reported Event|Control School|Control schools (where the coaches do not receive the Coaching Boys into Men (CBIM) training until following academic year 'wait list control')
808086|NCT01367665|B3|Baseline|Total|Total of all reporting groups
808087|NCT01367665|B2|Baseline|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
808088|NCT01367665|B1|Baseline|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
808089|NCT01367665|P2|Participant Flow|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
808093|NCT01367665|E2|Reported Event|Vismodegib - Metastatic|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
808094|NCT01367665|E1|Reported Event|Vismodegib - Locally Advanced|"Participants received vismodegib 150 mg orally once a day until one of the following occurs: Disease progression, intolerable toxicity most probably attributable to vismodegib, consent withdrawal, death, study termination by the Sponsor, or other reason deemed by the Investigator.~vismodegib: 150 mg once daily until disease progression or unacceptable toxicity"
808095|NCT01367457|B4|Baseline|Total|Total of all reporting groups
808096|NCT01367457|B3|Baseline|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
808097|NCT01367457|B2|Baseline|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808098|NCT01367457|B1|Baseline|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808099|NCT01367457|P3|Participant Flow|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
808100|NCT01367457|P2|Participant Flow|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808101|NCT01367457|P1|Participant Flow|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808102|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
808103|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808104|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808105|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
808106|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808107|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808108|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
808109|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808110|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808111|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
808112|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808113|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808114|NCT01367457|O3|Outcome|MCC: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
808115|NCT01367457|O2|Outcome|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808116|NCT01367457|O1|Outcome|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808153|NCT01367158|P1|Participant Flow|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
808117|NCT01367457|E3|Reported Event|MCL: Temsirolimus + Rituximab|Participants diagnosed with MCL who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as combination therapy with Rituximab.
809374|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
808118|NCT01367457|E2|Reported Event|MCL: Temsirolimus|Participants diagnosed with Mantle Cell Lymphoma (MCL) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus as monotherapy were included in this non-interventional study.
808119|NCT01367457|E1|Reported Event|RCC: Temsirolimus|Participants diagnosed with Renal Cell Carcinoma (RCC) who received treatment with Temsirolimus as per standard clinical practice and received at least 1 dose of Temsirolimus were included in this non-interventional study.
808120|NCT01367249|B3|Baseline|Total|Total of all reporting groups
808121|NCT01367249|B2|Baseline|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
808122|NCT01367249|B1|Baseline|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
808123|NCT01367249|P2|Participant Flow|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
808124|NCT01367249|P1|Participant Flow|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
808125|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
808126|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
808127|NCT01367249|O2|Outcome|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
808128|NCT01367249|O1|Outcome|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
808129|NCT01367249|E2|Reported Event|Placebo|"One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Placebo: Sterile ophthalmic solution, vehicle of bromfenac ophthalmic solution"
808130|NCT01367249|E1|Reported Event|Bromfenac Ophthalmic Solution|"Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.~Bromfenac Ophthalmic Solution: Sterile ophthalmic solution"
808131|NCT01367158|B12|Baseline|Total|Total of all reporting groups
808132|NCT01367158|B11|Baseline|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
808133|NCT01367158|B10|Baseline|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
808134|NCT01367158|B9|Baseline|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
808135|NCT01367158|B8|Baseline|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
808136|NCT01367158|B7|Baseline|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
808137|NCT01367158|B6|Baseline|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
808138|NCT01367158|B5|Baseline|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
808139|NCT01367158|B4|Baseline|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
808140|NCT01367158|B3|Baseline|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
808141|NCT01367158|B2|Baseline|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
808142|NCT01367158|B1|Baseline|3ABCWY|Two doses of MenABCWY vaccine (no outer membrane vesicle {OMV}) in the primary study and one dose of the same vaccine in the current study
808143|NCT01367158|P11|Participant Flow|1ACWY|One dose of MenACWY vaccine followed by one dose of placebo in the primary study and one dose of Tdap in the current study
808144|NCT01367158|P10|Participant Flow|2 B|Two doses of rMenB vaccine in the primary study and one dose of Tdap in the current study
808145|NCT01367158|P9|Participant Flow|3 B|Two doses of rMenB vaccine in the primary study and one dose of the same vaccine in the current study
808146|NCT01367158|P8|Participant Flow|2ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of Tdap in the current study
808147|NCT01367158|P7|Participant Flow|3ABCWYqOMV|Two doses of MenABCWY+1/4OMV vaccine in the primary study and one dose of the same vaccine in the current study
808148|NCT01367158|P6|Participant Flow|2ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of Tdap in the current study
808149|NCT01367158|P5|Participant Flow|3ABCWY+OMV|Two doses MenABCWY+OMV vaccine in the primary study and one dose of the same vaccine in the current study
808150|NCT01367158|P4|Participant Flow|2ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of Tdap in the current study
808151|NCT01367158|P3|Participant Flow|3ABx2CWY|Two doses of MenABx2CWY vaccine in the primary study and one dose of the same vaccine in the current study
808152|NCT01367158|P2|Participant Flow|2ABCWY|Two doses of MenABCWY vaccine (no OMV) in the primary study and one dose of Tdap in the current study
808155|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
812315|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
808156|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808157|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
808158|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808159|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
808160|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808161|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808162|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808163|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808164|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808165|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808166|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
808167|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808168|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
808169|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808170|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
808171|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808172|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808173|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808174|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808175|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808176|NCT01367158|O11|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808177|NCT01367158|O10|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
808178|NCT01367158|O9|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808179|NCT01367158|O8|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
808180|NCT01367158|O7|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808181|NCT01367158|O6|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
811231|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
809375|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
808182|NCT01367158|O5|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808183|NCT01367158|O4|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808184|NCT01367158|O3|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808185|NCT01367158|O2|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808186|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808187|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808188|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808189|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808190|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808191|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808192|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808193|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808194|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808195|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808196|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808197|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808198|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808199|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808200|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808201|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808202|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808203|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808204|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808205|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808206|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808207|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808208|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
809191|NCT01363492|E1|Reported Event|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
808209|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808210|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808211|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808212|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
808213|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
808214|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
808215|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808216|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808217|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808218|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
808219|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study.
808220|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
808221|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808222|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808223|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808224|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
808225|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
808226|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
808227|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808228|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808229|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808230|NCT01367158|O5|Outcome|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
808231|NCT01367158|O4|Outcome|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
808232|NCT01367158|O3|Outcome|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
808233|NCT01367158|O2|Outcome|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808234|NCT01367158|O1|Outcome|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808235|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808236|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808237|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808238|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808239|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808240|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808241|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808242|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808243|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808244|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808245|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808246|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808247|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808248|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808249|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808250|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808251|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808252|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808253|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808254|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808255|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808256|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808257|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808258|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808259|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808260|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808261|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808262|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808263|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
809192|NCT01363479|B3|Baseline|Total|Total of all reporting groups
808264|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808265|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808266|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808267|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808268|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808269|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808270|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808271|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808272|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808273|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808274|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808275|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808276|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808277|NCT01367158|O6|Outcome|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808278|NCT01367158|O5|Outcome|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808279|NCT01367158|O4|Outcome|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808280|NCT01367158|O3|Outcome|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808281|NCT01367158|O2|Outcome|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808282|NCT01367158|O1|Outcome|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808283|NCT01367158|E11|Reported Event|1ACWY|One dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine followed by one dose of placebo and one dose of Tdap in current study
808284|NCT01367158|E10|Reported Event|2 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of Tdap in current study
808285|NCT01367158|E9|Reported Event|3 B|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine in previous study and one dose of the same in current study
808286|NCT01367158|E8|Reported Event|2ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of Tdap in current study
808287|NCT01367158|E7|Reported Event|3ABCWYqOMV|Two doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus one quarter dose of outer membrane vesicles (qOMV) in previous study and one dose of the same in current study
808288|NCT01367158|E6|Reported Event|2ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of Tdap in current study
808289|NCT01367158|E5|Reported Event|3ABCWY+OMV|Two doses Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus outer membrane vesicles (OMV) in previous study and one dose of the same in current study
808290|NCT01367158|E4|Reported Event|2ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
809804|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
808291|NCT01367158|E3|Reported Event|3ABx2CWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808292|NCT01367158|E2|Reported Event|2ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of Tdap in current study
808293|NCT01367158|E1|Reported Event|3ABCWY|Two doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus one dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in previous study and one dose of the same in current study
808294|NCT01367119|B3|Baseline|Total|Total of all reporting groups
808295|NCT01367119|B2|Baseline|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
808296|NCT01367119|B1|Baseline|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
808297|NCT01367119|P2|Participant Flow|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
808298|NCT01367119|P1|Participant Flow|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
808299|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
808300|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
808301|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
808302|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
808303|NCT01367119|O2|Outcome|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
808304|NCT01367119|O1|Outcome|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
808305|NCT01367119|E2|Reported Event|Methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic prior to electroconvulsive therapy.
808306|NCT01367119|E1|Reported Event|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic prior to electroconvulsive therapy (ECT).
808307|NCT01367080|B3|Baseline|Total|Total of all reporting groups
808308|NCT01367080|B2|Baseline|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
808309|NCT01367080|B1|Baseline|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
808310|NCT01367080|P2|Participant Flow|B Group|Etravil tablet 25mg once daily in first intervention period and Etravil tablet 10mg once daily in second intervention period (10days washout period, Intervention period : 1day)
808311|NCT01367080|P1|Participant Flow|A Group|Etravil tablet 10mg once daily in first intervention period and Etravil tablet 25mg once daily in second intervention period (10days washout period, Intervention period : 1day)
808312|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
808313|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
808314|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
808315|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
808316|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline Hydrochloride 25mg Administration Group
808317|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg Administration Group
808318|NCT01367080|O2|Outcome|Etravil 25mg Group|Amitryptiline hydrochloride 25mg administration Group
808319|NCT01367080|O1|Outcome|Etravil 10mg Group|Amitryptiline Hydrochloride 10mg administration Group
808320|NCT01367080|E2|Reported Event|Etravil 25mg Group|Amitryptyline hydrochloride 25mg administration Group
808321|NCT01367080|E1|Reported Event|Etravil 10mg Group|Amitryptyline hydrochloride 10mg administration Group
808322|NCT01366976|B3|Baseline|Total|Total of all reporting groups
808323|NCT01366976|B2|Baseline|Placebo|Saline in equivalent volume as study drug
808324|NCT01366976|B1|Baseline|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
808325|NCT01366976|P2|Participant Flow|Placebo|Saline in equivalent volume as study drug
808326|NCT01366976|P1|Participant Flow|Acetaminophen|IV acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
808327|NCT01366976|O2|Outcome|Placebo|Saline infusion
808328|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
808329|NCT01366976|O2|Outcome|Placebo|Saline infusion
808330|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
808331|NCT01366976|O2|Outcome|Placebo|Saline infusion
808332|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
808333|NCT01366976|O2|Outcome|Placebo|Saline infusion
808334|NCT01366976|O1|Outcome|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
808335|NCT01366976|E2|Reported Event|Placebo|Saline infusion
808336|NCT01366976|E1|Reported Event|Acetaminophen|IV Acetaminophen 1g every 6 hours for 4 doses over a 24 hours study period
808337|NCT01366885|B1|Baseline|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
808338|NCT01366885|P1|Participant Flow|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
808339|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
808340|NCT01366885|O1|Outcome|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
808341|NCT01366885|E1|Reported Event|Intervention During Pregnancy|"5000 IU Vitamin D3 to be given to the mother during pregnancy. 7000 IU Vitamin D3 to be given during breast feeding if breast feeding. If not breastfeeding, infant to be given 400 IU Vitamin D3 during first year of age, then increased to 1000 IU D3 until completion of research trial.~Vitamin D3: 5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age."
808342|NCT01366872|B1|Baseline|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
808343|NCT01366872|P1|Participant Flow|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
808344|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
808345|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
808346|NCT01366872|O1|Outcome|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
808347|NCT01366872|E1|Reported Event|Agility LP Total Ankle Arthroplasty|Patients who underwent Total Ankle Arthroplasty using the Agility LP device a minimum of 2 years prior to study enrollment.
808348|NCT01366846|B5|Baseline|Total|Total of all reporting groups
808349|NCT01366846|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808350|NCT01366846|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
808351|NCT01366846|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808352|NCT01366846|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
808353|NCT01366846|P4|Participant Flow|Positive Stratum – Peanut Avoidance After Peanut Consumption G|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
808354|NCT01366846|P3|Participant Flow|Positive Stratum – Continued Peanut Avoidance Group|Participants who had a positive response to a peanut allergen skin prick test (a wheal measuring between 1 and 4 mm) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
808355|NCT01366846|P2|Participant Flow|Negative Stratum – Peanut Avoidance After Consumption Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut consumption group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial).
808356|NCT01366846|P1|Participant Flow|Negative Stratum – Continued Peanut Avoidance Group|Participants who had a negative response to a peanut allergen skin prick test (no measurable wheal) and were then randomized into the peanut avoidance group for the duration of LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784). As with participants of all treatment groups, these participants avoided peanut protein during the following LEAP-On study (this trial)
808432|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
809369|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
808357|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
808358|NCT01366846|O1|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
808359|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
808360|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
808361|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808362|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
808363|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808364|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
808365|NCT01366846|O2|Outcome|Peanut Avoidance After Peanut Consumption Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut consumption group were asked to consume at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts. Upon transitioning from LEAP (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784) to LEAP-On (this trial), participants were instructed to avoid peanut protein during study participation.
808366|NCT01366846|O1|Outcome|Continued Peanut Avoidance Group|In the LEAP trial (protocol ID ITN032AD, ClinicalTrials.gov ID NCT00329784), participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation. This group continued to avoid peanut protein throughout LEAP-On (this trial).
808367|NCT01366846|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808368|NCT01366846|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
808369|NCT01366846|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808370|NCT01366846|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
808371|NCT01366846|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808372|NCT01366846|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
811232|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
808373|NCT01366846|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
808374|NCT01366846|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
808375|NCT01366638|B4|Baseline|Total|Total of all reporting groups
808376|NCT01366638|B3|Baseline|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808377|NCT01366638|B2|Baseline|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808378|NCT01366638|B1|Baseline|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808379|NCT01366638|P3|Participant Flow|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808380|NCT01366638|P2|Participant Flow|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808381|NCT01366638|P1|Participant Flow|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808382|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808383|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808384|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808385|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808386|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808387|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808388|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808389|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808390|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808391|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808392|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808393|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808394|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808395|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808396|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808397|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808398|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808399|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808400|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808401|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808402|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808403|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808404|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808405|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808406|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808407|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808408|NCT01366638|O3|Outcome|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808409|NCT01366638|O2|Outcome|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808580|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
808410|NCT01366638|O1|Outcome|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808411|NCT01366638|E3|Reported Event|Prior Non-Responder: TMC435 100 mg 12 Wks+PR 48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 48.
808412|NCT01366638|E2|Reported Event|Prior Relapser: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808413|NCT01366638|E1|Reported Event|Treatment-Naive: TMC435 100 mg 12 Wks+PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2b and ribavirin (PR) for 12 weeks (Wks), followed by PR until Week 24 or Week 48. Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
808414|NCT01366534|B4|Baseline|Total|Total of all reporting groups
808415|NCT01366534|B3|Baseline|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808416|NCT01366534|B2|Baseline|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808417|NCT01366534|B1|Baseline|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808418|NCT01366534|P3|Participant Flow|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808419|NCT01366534|P2|Participant Flow|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808420|NCT01366534|P1|Participant Flow|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808421|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808422|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808423|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808424|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808425|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808426|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808427|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808428|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808429|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808430|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808431|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808433|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808434|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808435|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808436|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808437|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808438|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808439|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808440|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808441|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808442|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808443|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808444|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808445|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808446|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808447|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808448|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808449|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808450|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808451|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808452|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808453|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808454|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808581|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
808455|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808456|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808457|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808458|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808459|NCT01366534|O3|Outcome|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808460|NCT01366534|O2|Outcome|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808461|NCT01366534|O1|Outcome|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808462|NCT01366534|E3|Reported Event|Control Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were volunteers who did not receive any immunization but were subjected to the sporozoite challenge. The duration of the study was approximately 8 months for infectivity control subjects.
808463|NCT01366534|E2|Reported Event|GSK257049 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered 3 doses of GSK257049 vaccine at Months 0, 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808464|NCT01366534|E1|Reported Event|Ad35.CS.01 Group|Healthy male or non-pregnant female subjects, aged 18 to 50 years, were administered one dose of Ad35.CS.01 vaccine at Month 0, and 2 doses of GSK257049 at Months 1 and 2 intramuscularly in the deltoid of the non-dominant arm. The duration of the study was approximately 11 months for vaccinated subjects.
808465|NCT01366521|B5|Baseline|Total|Total of all reporting groups
808466|NCT01366521|B4|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808467|NCT01366521|B3|Baseline|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808468|NCT01366521|B2|Baseline|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808469|NCT01366521|B1|Baseline|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808470|NCT01366521|P4|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808471|NCT01366521|P3|Participant Flow|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808472|NCT01366521|P2|Participant Flow|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808473|NCT01366521|P1|Participant Flow|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808474|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808475|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808476|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808477|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808478|NCT01366521|O4|Outcome|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808479|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808480|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808481|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808482|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808483|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808484|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808485|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808486|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808487|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808488|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808489|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808490|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808491|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808492|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808493|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808494|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808495|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808496|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808497|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808498|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808499|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808635|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808500|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808501|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808502|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808503|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808504|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808505|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808506|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808507|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808508|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808509|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808510|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808511|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808512|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808513|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808514|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808515|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808516|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808517|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808518|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808519|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808520|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808521|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808582|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
808522|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808523|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808524|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808525|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808526|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808527|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808528|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808529|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808530|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808531|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808532|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808533|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808534|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808535|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808536|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808537|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808538|NCT01366521|O4|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808539|NCT01366521|O3|Outcome|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808540|NCT01366521|O2|Outcome|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808541|NCT01366521|O1|Outcome|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808542|NCT01366521|E5|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg administered intravenously (IV) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808543|NCT01366521|E4|Reported Event|Mepolizumab SC Overall|Combined results for participants receiving either mepolizumab 12.5 mg, 125 mg or 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808604|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
808544|NCT01366521|E3|Reported Event|Mepolizumab 250 mg SC|Participants received mepolizumab 250 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808545|NCT01366521|E2|Reported Event|Mepolizumab 125 mg SC|Participants received mepolizumab 125 mg administered SC (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808546|NCT01366521|E1|Reported Event|Mepolizumab 12.5 mg SC|Participants received mepolizumab 12.5 milligrams (mg) administered subcutaneously (SC) (two injections of the same volume) once every 4 weeks (for a total of three doses on Day 1, Day 28 and Day 56). Maintenance asthma therapy was continued unchanged throughout the study, unless medically indicated.
808547|NCT01366443|B1|Baseline|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
808548|NCT01366443|P1|Participant Flow|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
808549|NCT01366443|O2|Outcome|Pregnant Women (ROM Plus vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the new combination immunoassay ROM Plus containing a combination of monoclonal and polyclonal antibodies to Placental Protein 12 (PP12) and Alpha-fetoprotein (AFP). The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
808550|NCT01366443|O1|Outcome|Pregnant Women (Clinical Assessment vs. Chart Review)|This study was a multi-center prospective observational study performed in patients presenting with signs or symptoms of rupture of amniotic membranes. Initial evaluation included the standard clinical assessment for rupture of membranes. The clinical diagnosis of rupture of membranes was confirmed on review of the medical chart records following delivery.
808551|NCT01366443|E1|Reported Event|Women Pregnant|Healthy pregnant women between 15 or greater weeks gestation reporting with signs or symptoms of rupture of membranes.
808552|NCT01366417|B1|Baseline|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
808553|NCT01366417|P1|Participant Flow|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
808554|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
808555|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
808556|NCT01366417|O2|Outcome|70% Isopropyl Alcohol|All subjects received a single topical application of 70% Isopropyl Alcohol.
808557|NCT01366417|O1|Outcome|ChloraPrep One Step|All subjects received a single topical application of ChloraPrep One Step.
808558|NCT01366417|E1|Reported Event|ChloraPrep One Step and 70% Isopropyl Alcohol|All subjects received a single topical treatment with both the test article (ChloraPrep One Step) and the positive control (Isopropyl Alcohol)
808559|NCT01366209|B3|Baseline|Total|Total of all reporting groups
808560|NCT01366209|B2|Baseline|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
808561|NCT01366209|B1|Baseline|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
808562|NCT01366209|P2|Participant Flow|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
808563|NCT01366209|P1|Participant Flow|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
808564|NCT01366209|O2|Outcome|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
808565|NCT01366209|O1|Outcome|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
808566|NCT01366209|E2|Reported Event|Placebo Arm|Placebo: Placebo equivalent given as 3 divided doses 3 times per day.
808567|NCT01366209|E1|Reported Event|Active Arm|Pirfenidone: Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
808568|NCT01366092|B1|Baseline|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808569|NCT01366092|P1|Participant Flow|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808570|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808571|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808572|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808573|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808574|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808575|NCT01366092|O1|Outcome|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808576|NCT01366092|E1|Reported Event|Interleukin-2|Interleukin-2: Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
808577|NCT01365910|B1|Baseline|Treatment (Enzyme Inhibitor)|Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
808578|NCT01365910|P1|Participant Flow|Treatment (Enzyme Inhibitor)|ABT-869/Linifanib will be administered orally on a daily basis at 17.5 mg/day (fixed dose). The drug is provided in tablets of 2.5 mg or 10 mg tablets.This course of treatment repeats every 28 days until disease progression, intolerability, investigator decision or patient withdrawal of consent.
808579|NCT01365910|O1|Outcome|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
808583|NCT01365910|E1|Reported Event|Treatment (Enzyme Inhibitor)|"Patients receive linifanib PO QD. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~linifanib: Given PO"
808584|NCT01365845|B1|Baseline|Breast Patients Planned With Both Proton & Conventional Plans|"Each patient is planned with both proton and conventional plans and the superior plan is chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
808585|NCT01365845|P3|Participant Flow|3D-Proton/Conventional Plan or 3D-proton Only|"3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
808586|NCT01365845|P2|Participant Flow|Conventional Photon Plan|"Conventional (photon): 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~This number will automatically be equal to 0 during the 'induction phase' period and will only have a count in the 'treatment phase' period if a patient was actually assigned to this treatment."
808587|NCT01365845|P1|Participant Flow|Induction Phase|During this phase, each patient will have both a proton and conventional radiation plan performed. The superior plan in regard to minimizing dose to heart will be the plan actually chosen for treating the patient.
808588|NCT01365845|O2|Outcome|3D-Proton/Conventional Plan or 3D-proton Only|3D-Proton/Conventional plan or 3D-proton only: 50.4 Cobalt Gray Equivalent (CGE)/Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 CGE/Gy per fraction
808589|NCT01365845|O1|Outcome|Conventional Photon Plan|Photon: 50.4 Gray (Gy) to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
808590|NCT01365845|E1|Reported Event|Breast Patients Planned With Both Proton & Conventional Plans|"All patients ultimately treated under the proton plan, so the denominator for all adverse events refers exclusively to the proton arm and not conventional.~Each patient was planned with both proton and conventional plans and the superior plan was chosen for treatment.~Conventional plan: 50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction~Proton plan: 50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction"
808591|NCT01365819|B3|Baseline|Total|Total of all reporting groups
808592|NCT01365819|B2|Baseline|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808593|NCT01365819|B1|Baseline|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808594|NCT01365819|P2|Participant Flow|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808595|NCT01365819|P1|Participant Flow|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808596|NCT01365819|O2|Outcome|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808597|NCT01365819|O1|Outcome|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808598|NCT01365819|E2|Reported Event|Varenicline|"Varenicline (Chantix (R))~Varenicline: Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808599|NCT01365819|E1|Reported Event|Sugar Pill|"Placebo~Placebo: Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9)."
808600|NCT01365650|B1|Baseline|All Study Participants|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
808601|NCT01365650|P1|Participant Flow|Symptomatic Allergic Rhinitis|Treatment A: Single intranasal (i.n.) dose of Ketorolac tromethamine (KT) 30 mg (one 15 mg spray into each nostril) on day 1 of Period 1 followed by a 2-7 day washout interval Treatment B: Single i.n. dose of oxymetazoline hydrochloride (OH) followed 30 minutes later by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) of Period 2 followed by a 2-7 day washout interval Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of KT 30 mg (one 15 mg spray into each nostril) on day 1 of Period 3
808602|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
808603|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
811233|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
808605|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
808606|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
808607|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
808608|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
808609|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
808610|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
808611|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
808612|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
808613|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
808614|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
808615|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
808616|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
808617|NCT01365650|O3|Outcome|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
808618|NCT01365650|O2|Outcome|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
808619|NCT01365650|O1|Outcome|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
808620|NCT01365650|E3|Reported Event|Seven Days of Treatment With i.n. Fluticasone Propionate|Treatment C: Seven days of treatment with i.n. fluticasone propionate (between Periods 2 and 3) followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 3.
808621|NCT01365650|E2|Reported Event|Single i.n. Dose of Oxymetazoline Hydrochloride Followed by a|Treatment B: Single i.n. dose of oxymetazoline hydrochloride followed by a single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2.
808622|NCT01365650|E1|Reported Event|Single i.n. Dose of 30 mg Ketorolac Tromethamine|Treatment A: Single i.n. dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on day 1 of Period 1.
808623|NCT01365624|B3|Baseline|Total|Total of all reporting groups
808624|NCT01365624|B2|Baseline|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808625|NCT01365624|B1|Baseline|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808626|NCT01365624|P2|Participant Flow|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808627|NCT01365624|P1|Participant Flow|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808628|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808629|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808630|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808631|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808632|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808633|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808634|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
811234|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
808636|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808637|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808638|NCT01365624|O2|Outcome|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808639|NCT01365624|O1|Outcome|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808640|NCT01365624|E2|Reported Event|Ketorolac Tromethamine (Nonelderly Adults < 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808641|NCT01365624|E1|Reported Event|Ketorolac Tromethamine (Elderly Adults ≥ 65)|Ketorolac tromethamine : Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
808642|NCT01365611|B1|Baseline|All Study Participants|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808643|NCT01365611|P1|Participant Flow|All Study Participants|"A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.~Subjects received a single daily intranasal dose of 200mg fluticasone propionate on Days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6."
808644|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808645|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
808646|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808647|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
808648|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808649|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
808650|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808651|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
808652|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808653|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
808654|NCT01365611|O2|Outcome|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808655|NCT01365611|O1|Outcome|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
808656|NCT01365611|E2|Reported Event|Fluticasone Propionate + Ketorolac Tromethamine|Subjects received a single daily intranasal dose of 200mg fluticasone propionate on days 2-6 followed by a single intranasal dose of 30mg ketorolac tromethamine administered 30 minutes after fluticasone propionate on Day 6.
808657|NCT01365611|E1|Reported Event|Ketorolac Tromethamine (Given Alone)|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
808658|NCT01365585|B1|Baseline|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808659|NCT01365585|P1|Participant Flow|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808660|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808661|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808662|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808663|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808664|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808665|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808666|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808667|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808668|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808669|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808670|NCT01365585|O1|Outcome|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808671|NCT01365585|E1|Reported Event|Sildenafil|Participants who received sildenafil greater than or equal to 20 milligram (mg) three times daily as per Summary of Product Characteristics (SmPC) for the treatment of pulmonary arterial hypertension (PAH) for a period of at least 3 months, were observed retrospectively for 5 years.
808672|NCT01365546|B1|Baseline|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
808673|NCT01365546|P1|Participant Flow|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
808674|NCT01365546|O1|Outcome|Post-operative Assessment by IDMC|
808675|NCT01365546|O1|Outcome|Intra-operative Assessment by IDMC|
808676|NCT01365546|O3|Outcome|All Surgeries|
808677|NCT01365546|O2|Outcome|Major Surgery|
808678|NCT01365546|O1|Outcome|Minor Surgery|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
808679|NCT01365546|E1|Reported Event|Human VWF/FVIII Concentrate|human VWF/FVIII concentrate: intravenous infusion. Dose based on subject's individual invivo-recovery
808680|NCT01365507|B3|Baseline|Total|Total of all reporting groups
808681|NCT01365507|B2|Baseline|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808682|NCT01365507|B1|Baseline|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808683|NCT01365507|P2|Participant Flow|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808684|NCT01365507|P1|Participant Flow|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808685|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808686|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808687|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808688|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808689|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808690|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808691|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808692|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808693|NCT01365507|O2|Outcome|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808694|NCT01365507|O1|Outcome|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808695|NCT01365507|E2|Reported Event|IDegAsp Step Wise|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (at least 5 days intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
808696|NCT01365507|E1|Reported Event|IDegAsp Simple|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (3-4 days intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed twice weekly based on pre-breakfast self-measured plasma glucose (SMPG) value measured on the day of insulin titration.
808697|NCT01365494|B3|Baseline|Total|Total of all reporting groups
808698|NCT01365494|B2|Baseline|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedules."
808699|NCT01365494|B1|Baseline|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedules."
808700|NCT01365494|P2|Participant Flow|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
808701|NCT01365494|P1|Participant Flow|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to either Zagreb schedule."
808702|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
808703|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
808704|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
808705|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb schedule) (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
808706|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
808707|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
808708|NCT01365494|O2|Outcome|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
808709|NCT01365494|O1|Outcome|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
808710|NCT01365494|E2|Reported Event|Essen|"Rabipur vaccine, administered IM according to the 1-1-1-1-1 (Essen) schedule (i.e., 1 dose of vaccine administered on day 0, 3, 7, 14 and 28)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Essen group received Rabipur vaccine intramuscularly according to Essen schedule."
808711|NCT01365494|E1|Reported Event|Zagreb|"Rabipur vaccine, administered intramuscularly (IM) according to the 2-1-1 (Zagreb) schedule (i.e., 2 doses of vaccine administered on day 0 and 1 dose of vaccine each administered on day 7 and day 21)~Purified Chick Embryo Cell Inactivated Rabies Vaccine: Zagreb group received Rabipur vaccine intramuscularly according to Zagreb schedule."
808712|NCT01365481|B5|Baseline|Total|Total of all reporting groups
808713|NCT01365481|B4|Baseline|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808714|NCT01365481|B3|Baseline|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808715|NCT01365481|B2|Baseline|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808716|NCT01365481|B1|Baseline|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808717|NCT01365481|P4|Participant Flow|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808718|NCT01365481|P3|Participant Flow|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808719|NCT01365481|P2|Participant Flow|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808720|NCT01365481|P1|Participant Flow|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808721|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808722|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808723|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808724|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808725|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
811235|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
808726|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808727|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808728|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808729|NCT01365481|O2|Outcome|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808730|NCT01365481|O1|Outcome|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808731|NCT01365481|E6|Reported Event|Non-CKD Patients: Valsartan Alone|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808732|NCT01365481|E5|Reported Event|Non-CKD Patients: Valsartan + Antihypertensive Group|Non-CKD patients-Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808733|NCT01365481|E4|Reported Event|CKD Patients: Valsartan Alone|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808734|NCT01365481|E3|Reported Event|CKD Patients: Valsartan + Antihypertensive Group|CKD Patients - Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808735|NCT01365481|E2|Reported Event|Valsartan Alone|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg.
808736|NCT01365481|E1|Reported Event|Valsartan + Antihypertensive Group|Valsartan starting dose: ≥18 kg to <35 kg is 40 mg, ≥35 kg to <80 kg is 80 mg, ≥80 kg to ≤160 kg is 160 mg for 1 week then Valsartan maintenance dose: ≥18 kg to <35 kg is 80 mg, ≥35 kg to <80 kg is 160 mg, ≥80 kg to ≤160 kg is 320 mg after Week 8 if the Mean Sitting Systolic Blood Pressure (MSSBP) and/or Mean Sitting Diastolic Blood Pressure (MSDBP) was higher than 95th percentile for age, gender and height under the maintenance valsartan dose then add amlodipine and/or Hydrochlorothiazide (HCTZ). The valsartan +antihypertensive group includes patients who received background antihypertensive medication or received antihypertensive medication including amlodipine or HCTZ during the study.
808737|NCT01365468|B3|Baseline|Total|Total of all reporting groups
808738|NCT01365468|B2|Baseline|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808739|NCT01365468|B1|Baseline|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808757|NCT01365455|P4|Participant Flow|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808740|NCT01365468|P2|Participant Flow|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808741|NCT01365468|P1|Participant Flow|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808742|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808743|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808744|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808745|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808746|NCT01365468|O2|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808747|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808748|NCT01365468|O1|Outcome|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808749|NCT01365468|O1|Outcome|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808750|NCT01365468|E2|Reported Event|Stratum 2|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity that do not have documented progression of the PN at the time of study entry were enrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808751|NCT01365468|E1|Reported Event|Stratum 1|Adults and children with neurofibromatosis type 1 (NF1) and inoperable plexiform neurofibromas (PN) with the potential to cause significant morbidity with documented progressive PN prior to study entry wereenrolled in this stratum. Enrolled patients received everolimus (RAD001) in an open label manner. Recommended starting dose of everolimus depend on body surface area, starting from 2.5 mg once daily to 7.5 mg once daily.
808752|NCT01365455|B4|Baseline|Total|Total of all reporting groups
808753|NCT01365455|B3|Baseline|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808754|NCT01365455|B2|Baseline|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808755|NCT01365455|B1|Baseline|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808756|NCT01365455|P5|Participant Flow|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
809370|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
808758|NCT01365455|P3|Participant Flow|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808759|NCT01365455|P2|Participant Flow|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808760|NCT01365455|P1|Participant Flow|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808761|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808762|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808763|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808764|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808765|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808766|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808767|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808768|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808769|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808770|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808771|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808772|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808773|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808774|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808775|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808776|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
809805|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
808777|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808778|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808779|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808780|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808781|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808782|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808783|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808784|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808785|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808786|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808787|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808788|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808789|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808790|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808791|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808792|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808793|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808794|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808795|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
809806|NCT01362140|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
808796|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808797|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808798|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808799|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808800|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808801|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808802|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808803|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808804|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808805|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808806|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808807|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808808|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808809|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808810|NCT01365455|O5|Outcome|AIN457 300mg From Placebo|Patients randomized to AIN457 300mg in Maintenance phase when they were on Placebo in Induction Phase. PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808811|NCT01365455|O4|Outcome|AIN457 150mg From Placebo|Patients randomized to AIN457 150mg in Maintenance phase when they were on Placebo in Induction Phase because they were PASI 75 non-responders and received their treatment on Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808812|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808813|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808814|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
809807|NCT01362140|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
808815|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808816|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808817|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808818|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808819|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808820|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808821|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808822|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808823|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808824|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808825|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808826|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808827|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808828|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808829|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808830|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808831|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808832|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
809371|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
808833|NCT01365455|O3|Outcome|Placebo|placebo secukinumab (two s.c. injections per dose) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response at Week 12. PASI 75 responders: continued on placebo and received their placebo injections at Weeks 12, 13, 14, 15, and then every 4 weeks starting at Week 16 until Week 48.
808834|NCT01365455|O2|Outcome|AIN457 300 mg|AIN457 secukinumab 300 mg (two s.c. injections of 150 mg) once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808835|NCT01365455|O1|Outcome|AIN457 150 mg|AIN457 secukinumab 150 mg subcutaneous (s.c.) injection plus a placebo secukinumab s.c. injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4 and until Week 48, except for Weeks 13, 14, and 15 when they received two s.c. injections of placebo per week
808836|NCT01365455|E11|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
808837|NCT01365455|E10|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
808838|NCT01365455|E9|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
808839|NCT01365455|E8|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
808840|NCT01365455|E7|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
808841|NCT01365455|E6|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
808842|NCT01365455|E5|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
808843|NCT01365455|E4|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
808844|NCT01365455|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
808845|NCT01365455|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
808846|NCT01365455|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
808847|NCT01365273|B3|Baseline|Total|Total of all reporting groups
808848|NCT01365273|B2|Baseline|Mepitel One|Device
808849|NCT01365273|B1|Baseline|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
808850|NCT01365273|P2|Participant Flow|Mepitel One|Device
808851|NCT01365273|P1|Participant Flow|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
808852|NCT01365273|O2|Outcome|Mepitel One|Device
808853|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
808854|NCT01365273|O2|Outcome|Mepitel One|Device
808855|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
808856|NCT01365273|O2|Outcome|Mepitel One|Device
808857|NCT01365273|O1|Outcome|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
808858|NCT01365273|E2|Reported Event|Mepitel One|Device
808859|NCT01365273|E1|Reported Event|Bridal Veil and Staples|Bridal Veil and staples are standard of care I
808860|NCT01365130|B1|Baseline|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
808861|NCT01365130|P1|Participant Flow|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
808862|NCT01365130|O1|Outcome|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
808863|NCT01365130|E1|Reported Event|Real Drug|"patients will receive Jevtana 25mg/m2, IV every 21 days until disease progression or unacceptable toxicity~jevtana: Cabazitaxel 25mg/m2, IV every 21 days until progression"
808864|NCT01365091|B5|Baseline|Total|Total of all reporting groups
808865|NCT01365091|B4|Baseline|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
808866|NCT01365091|B3|Baseline|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
808867|NCT01365091|B2|Baseline|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
808915|NCT01365039|B2|Baseline|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808964|NCT01364649|B2|Baseline|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
808868|NCT01365091|B1|Baseline|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
808869|NCT01365091|P4|Participant Flow|Arm 4: Treatments G/ H, H/G|"Period 1: Participants received a single oral dose of saxagliptin , 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
808870|NCT01365091|P3|Participant Flow|Arm 3:Treatments E/ F, F/E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
808871|NCT01365091|P2|Participant Flow|Arm 2: Treatments C/D, D/C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
808872|NCT01365091|P1|Participant Flow|Arm 1: Treatments A/B, B/A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
808873|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
808874|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
808875|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
808876|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC to Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
808955|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
808956|NCT01364740|E1|Reported Event|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
809808|NCT01362062|B3|Baseline|Total|Total of all reporting groups
808877|NCT01365091|O4|Outcome|Arm 4: Treatments G,H/H,G|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fed state (Treatment G)."
808878|NCT01365091|O3|Outcome|Arm 3: Treatments E,F/ F,E|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg and metformin extended-release (XR), 1000-mg tablets together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5- mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 1000 mg FDC, in the fasted state (Treatment E)."
808879|NCT01365091|O2|Outcome|Arm 2: Treatments C,D/D,C|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metforminXR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fed state (Treatment C)."
808880|NCT01365091|O1|Outcome|Arm 1: Treatments A,B/B,A|"Period 1: Participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin extended-release (XR), 500-mg, tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500 mg FDC, in the fasted state (Treatment A)."
808881|NCT01365091|O4|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
808882|NCT01365091|O3|Outcome|Sax, 5 mg/Met XR, 1000 mg: Sax, 5 mg/Met, 1000 mg FDC Fasting|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
808883|NCT01365091|O2|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met 500 mg FDC Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
808884|NCT01365091|O1|Outcome|Sax, 5 mg/Met, 500 mg: Sax, 5 mg/Met, 500 mg FDC Fasting|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
808885|NCT01365091|O4|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fed|"Arm 4: Treatments G,H/H,G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment G), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fed state (Treatment H), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fed state (Treatment G)."
808957|NCT01364727|B1|Baseline|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
808958|NCT01364727|P1|Participant Flow|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
808959|NCT01364727|O1|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
808886|NCT01365091|O3|Outcome|Sax, 5 mg/Met 1000 mg XR FDC to Individual Tablets, Fasted|"Arm 3: Treatment E, F/F, G. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 1000-mg extended-release (XR) fixed-dose combination (FDC), in the fasted state (Treatment E), followed by a washout period of at least 7 days. Participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 1000-mg tablets, together in the fasted state (Treatment F). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 1000-mg tablets together in the fasted state (Treatment F), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 1000-mg FDC, in the fasted state (Treatment E)."
808887|NCT01365091|O2|Outcome|Sax, 5 mg/Met 500 mg vs FDC to Individual Tablets, Fed|"Arm 2: Treatment C, D/D, C. Period 1: Participants received a single oral dose of saxagliptin (sax) 5-mg/metformin (met) 500-mg, extended-release (XR) fixed-dose combination (FDC), in the fed state (Treatment C), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fed state (Treatment D). Followed by a washout period of at least 4 days.~Period 2: Participants received a single oral dose of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fed state (Treatment D), followed by a washout period of at least 7 days. Participants received a single oral dose of saxagliptin, 5-mg/metformin, 500-mg XR FDC, in the fed state (Treatment C)."
808888|NCT01365091|O1|Outcome|Sax, 5 mg/Met 500 mg XR FDC vs Individual Tablets, Fasted|"Arm 1: Treatments A, B/B, A. Period 1: Participants received a single oral dose of saxagliptin (sax), 5-mg/metformin (met), 500-mg extended-release (XR) fixed-dose combination (FDC) in the fasted state (Treatment A), followed by a washout period of at least 7 days. Then, participants received single oral doses of saxagliptin, 5-mg, and metformin XR, 500-mg tablets together in the fasted state (Treatment B). Followed by a washout period of at least 4 days.~Period 2: Participants received single oral doses of saxagliptin, 5-mg and metformin XR, 500-mg tablets together in the fasted state (Treatment B), followed by a washout period of at least 7 days. Then, participants received a single oral dose of saxagliptin, 5 mg/metformin, 500-mg FDC, in the fasted state (Treatment A)."
808889|NCT01365091|E8|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fed|FDC=fixed-dose combination
808890|NCT01365091|E7|Reported Event|Saxagliptin, 5 mg/Metformin, 500 mg FDC Fasting|FDC=fixed-dose combination
808891|NCT01365091|E6|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fed|FDC=fixed-dose combination
808892|NCT01365091|E5|Reported Event|Saxagliptin, 5 mg/Metformin, 1000 mg FDC Fasting|FDC=fixed-dose combination
808893|NCT01365091|E4|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fed|XR=extended release
808894|NCT01365091|E3|Reported Event|Saxagliptin, 5 mg/Metformin XR, 500 mg Fasting|XR=extended release
808895|NCT01365091|E2|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fed|XR=extended release
808896|NCT01365091|E1|Reported Event|Saxagliptin, 5 mg/Metformin XR, 1000 mg Fasting|XR=extended release
808897|NCT01365052|B3|Baseline|Total|Total of all reporting groups
808898|NCT01365052|B2|Baseline|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808899|NCT01365052|B1|Baseline|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808900|NCT01365052|P2|Participant Flow|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808901|NCT01365052|P1|Participant Flow|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808902|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808903|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808904|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808905|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808906|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808907|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808908|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808909|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808910|NCT01365052|O2|Outcome|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808911|NCT01365052|O1|Outcome|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808912|NCT01365052|E2|Reported Event|Placebo|2 over-encapsulated tablets of placebo are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
808913|NCT01365052|E1|Reported Event|Naproxen Sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
808914|NCT01365039|B3|Baseline|Total|Total of all reporting groups
808960|NCT01364727|O1|Outcome|Amrubicin|Amrubicin 35mg/m2 IV days 1 to 3 every 3 weeks until progression or toxicity
808916|NCT01365039|B1|Baseline|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808917|NCT01365039|P2|Participant Flow|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808918|NCT01365039|P1|Participant Flow|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808919|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808920|NCT01365039|O1|Outcome|SofLens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808921|NCT01365039|O2|Outcome|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808922|NCT01365039|O1|Outcome|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808923|NCT01365039|E2|Reported Event|Test Lens|"Test contact lens will be worn on a daily disposable wear basis.~Test, daily disposable contact lens : Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808924|NCT01365039|E1|Reported Event|SofLens Lens|"The currently marketed Bausch + Lomb SofLens daily disposable contact lens. Worn on a daily disposable wear basis.~SofLens daily disposable contact lens : Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality."
808925|NCT01364922|B4|Baseline|Total|Total of all reporting groups
808926|NCT01364922|B3|Baseline|DB Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
808927|NCT01364922|B2|Baseline|DB Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
808928|NCT01364922|B1|Baseline|OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized)|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period.
808929|NCT01364922|P3|Participant Flow|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
808930|NCT01364922|P2|Participant Flow|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
808931|NCT01364922|P1|Participant Flow|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks.
808932|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
808933|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
808934|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
808935|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
808936|NCT01364922|O2|Outcome|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks.
808937|NCT01364922|O1|Outcome|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
808938|NCT01364922|E3|Reported Event|Double-blind Placebo|1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period.
808939|NCT01364922|E2|Reported Event|Double-blind Hydrocodone/Acetaminophen Extended Release|1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period.
808940|NCT01364922|E1|Reported Event|Open-label Hydrocodone/Acetaminophen Extended Release|2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period.
808961|NCT01364727|O1|Outcome|Amrubicin|
808962|NCT01364727|E1|Reported Event|Amrubicin|Amrubicin 35mg/m2 IV days 1-3 every 3 weeks until progression or toxicity
808963|NCT01364649|B3|Baseline|Total|Total of all reporting groups
808941|NCT01364896|B1|Baseline|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
808942|NCT01364896|P1|Participant Flow|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
808943|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
808944|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
808945|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
808946|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
808947|NCT01364896|O1|Outcome|Inflammatory Bowel Disease, Immunosuppressive Agent|"Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent~Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples: Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria~Anal cytology testing"
808948|NCT01364896|E1|Reported Event|Inflammatory Bowel Disease, Immunosuppressive Agent|Men and women 18 years + with a histological diagnosis of IBD (ulcerative colitis or Crohn's disease) who are undergoing a colonoscopy prior to starting a non-corticosteroid immunosuppressive agent
808949|NCT01364740|B1|Baseline|PMP-300E, In-Lab PSG|"PMP-300E, In-Lab PSG: PMP-300E, A 7-channel (nasal pressure, effort, snoring, SpO2, pulse rate, body position and movement) Level 3 portable monitor (11.2 x 3.3 x 5.5cm, 80g, Pacific Medico Co., LTD) to measure sleep-related breathing will be tested against conventional gold-standard In-Lab Polysomnography (sleep study)~PMP-300E: Data collected from Level 3 device~In-lab PSG: Data collected from Type I In-Lab Polysomnography"
808950|NCT01364740|P1|Participant Flow|SmartWatch PMP-300E|"Investigational device Smart Watch PMP-300E to measure sleep-related breathing was tested against conventional gold-standard In-Lab Polysomnography (sleep studies)~Smart Watch PMP-300E: Data collected from a Level 3 portable monitoring device~In-lab Polysomnography: Data collected from Type I In-Lab Polysomnography"
808951|NCT01364740|O1|Outcome|PMP-300E|Patient questionnaire data collected after one night with the PMP-300E
808952|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
808953|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
808954|NCT01364740|O1|Outcome|PMP-300E, In-Lab Polysomnography|Patient data from one night with the PMP-300E, compared to In-Lab PSG data
808965|NCT01364649|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
808966|NCT01364649|P2|Participant Flow|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
808967|NCT01364649|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
808968|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
808969|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
808970|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
808971|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
808972|NCT01364649|O2|Outcome|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
808973|NCT01364649|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
808974|NCT01364649|E2|Reported Event|Escitalopram|Escitalopram 10 mg, tablets, orally, once daily for 1 week, then escitalopram dose adjustment to a maximum 20 mg, capsules, orally, once daily for up to 7 weeks. At week 8, escitalopram 10 mg, capsules, capsules, orally, once daily for 1 week only
808975|NCT01364649|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, then dose adjustment to a maximum 20 mg tablets, orally, once daily for up to 7 weeks. At week 8, vortioxetine placebo-matching capsules, orally, once daily for 1 week only.
808976|NCT01364558|B1|Baseline|Diazepam Nasal Spray Suspension/Spray/Injection|
808977|NCT01364558|P3|Participant Flow|Diazepam Injection|Diazepam injection
808978|NCT01364558|P2|Participant Flow|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
808979|NCT01364558|P1|Participant Flow|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
808980|NCT01364558|O3|Outcome|Diazepam Injection|Diazepam injection
808981|NCT01364558|O2|Outcome|Diazepam Nasal Spray Solution|Diazepam Nasal Spray Solution
808982|NCT01364558|O1|Outcome|Diazepam Nasal Spray Suspension|Diazepam Nasal Spray Suspension
808983|NCT01364558|E3|Reported Event|Diazepam Injection|
808984|NCT01364558|E2|Reported Event|Diazepam Nasal Spray Solution|
808985|NCT01364558|E1|Reported Event|Diazepam Nasal Spray Suspension|
808986|NCT01364428|B3|Baseline|Total|Total of all reporting groups
808987|NCT01364428|B2|Baseline|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
808988|NCT01364428|B1|Baseline|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
808989|NCT01364428|P2|Participant Flow|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
808990|NCT01364428|P1|Participant Flow|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
808991|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
808992|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
808993|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
809072|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
808994|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
808995|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
808996|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
808997|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
808998|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
808999|NCT01364428|O2|Outcome|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
809000|NCT01364428|O1|Outcome|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
809001|NCT01364428|E2|Reported Event|IDeg|Insulin degludec 100 U/mL (IDeg) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment (metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg was administered at any time of the day but preferably at the same time each day.
809002|NCT01364428|E1|Reported Event|IDeg 200 U/mL|Insulin degludec 200 U/mL (IDeg 200 U/mL) in a 3 mL prefilled pen PDS290 was given subcutaneously once daily in combination with pre-trial oral antidiabetic drug treatment(metformin, insulin secretagogue [sulfonylurea or glinide], alpha-glucosidase inhibitor, pioglitazone or DPP-IV inhibitor). IDeg 200 U/mL was administered at any time of the day but preferably at the same time each day.
809003|NCT01364389|B4|Baseline|Total|Total of all reporting groups
809004|NCT01364389|B3|Baseline|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
809005|NCT01364389|B2|Baseline|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809006|NCT01364389|B1|Baseline|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809007|NCT01364389|P3|Participant Flow|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
809008|NCT01364389|P2|Participant Flow|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809009|NCT01364389|P1|Participant Flow|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809010|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
809011|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809012|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809013|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
809014|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809015|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809016|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
809017|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809018|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809019|NCT01364389|O3|Outcome|Prednisone|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
809020|NCT01364389|O2|Outcome|AIN457|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809021|NCT01364389|O1|Outcome|ACZ885|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809022|NCT01364389|E3|Reported Event|Prednisone 20mg|On day 1, patients received daily oral doses of prednisone 20 mg along with daily oral placebo doses to in a double-dummy manner to maintain the blind. On day 15, partial and complete responders continued in the study and tapered their steroid treatment according to standard care. Non-responders were discontinued from the study.
809023|NCT01364389|E2|Reported Event|AIN457 3mg/kg|On day 1, patients received a single intravenous dose of AIN457 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of AIN457 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809024|NCT01364389|E1|Reported Event|ACZ885 3mg/kg|On day 1, patients received a single intravenous dose of ACZ885 3mg/kg along with a placebo intravenous infusion in a double dummy manner to maintain the blind. On day 15, partial and complete responders continued in the open label phase of this treatment arm where they were eligible to receive one re-dose of ACZ885 upon confirmed disease flare. Non-responders started a 20 mg dose cycle of prednisone or prednisolone followed by standard steroid tapering.
809025|NCT01364298|B3|Baseline|Total|Total of all reporting groups
809026|NCT01364298|B2|Baseline|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809027|NCT01364298|B1|Baseline|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809028|NCT01364298|P2|Participant Flow|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
811236|NCT01357239|O2|Outcome|Placebo|2 capsules of placebo per intake
809029|NCT01364298|P1|Participant Flow|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809030|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809031|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809032|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809033|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809034|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809035|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809036|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809037|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809038|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809039|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809040|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809041|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809042|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809071|NCT01363986|P1|Participant Flow|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 milligrams per kilogram (mg/kg) trastuzumab intravenously (i.v.) on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
809135|NCT01363713|E1|Reported Event|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
809043|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809044|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809045|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809046|NCT01364298|O2|Outcome|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809047|NCT01364298|O1|Outcome|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809048|NCT01364298|E2|Reported Event|Pregabalin|Pregabalin (Lyrica®) capsule administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed was 600 mg/day. The total duration of treatment was 84 days (12 weeks).
809049|NCT01364298|E1|Reported Event|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed was 3600 mg/day. The total duration of treatment was 84 days (12 weeks).
809050|NCT01364259|B3|Baseline|Total|Total of all reporting groups
809051|NCT01364259|B2|Baseline|Amifostine|"Amifostine and CyberKnife stereotactic radiosurgery~CyberKnife stereotactic radiosurgery + amofostine"
809052|NCT01364259|B1|Baseline|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery + saline"
809053|NCT01364259|P2|Participant Flow|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
809054|NCT01364259|P1|Participant Flow|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
809055|NCT01364259|O2|Outcome|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
809056|NCT01364259|O1|Outcome|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
809057|NCT01364259|O2|Outcome|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
809058|NCT01364259|O1|Outcome|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
809059|NCT01364259|E2|Reported Event|Amifostine|"Amifostine and SRS~CyberKnife stereotactic radiosurgery and Amifostine"
809060|NCT01364259|E1|Reported Event|Placebo|"Placebo and SRS~CyberKnife stereotactic radiosurgery (srs)"
809061|NCT01364207|B1|Baseline|All Participants Who Completed Both Study Visits|Only those 106 participants who completed both study visits were included in baseline and final data analyses. The 6 participants who did not complete both study visits were not included in any baseline or final data analyses.
809062|NCT01364207|P2|Participant Flow|Decaffeinated Coffee 1st Visit, Caffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of decaffeinated coffee on the their first visit, and then an 8 oz cup of caffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
809063|NCT01364207|P1|Participant Flow|Caffeinated Coffee 1st Visit, Decaffeinated Coffee 2nd Visit|Participants drank an 8 oz cup of caffeinated coffee on the their first visit, and then an 8 oz cup of decaffeinated coffee on their second visit. The second visit was completed 2 days to 4 weeks after the first visit, depending on the participants' schedules. Participants did not ingest caffeine in any form starting from 12:01am the day of the visit until after the visit that day except for the study coffee we gave to them.
809064|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
809065|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
809066|NCT01364207|O2|Outcome|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
809067|NCT01364207|O1|Outcome|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
809068|NCT01364207|E2|Reported Event|Decaffeinated Coffee|Participants drank an 8 oz cup of decaffeinated coffee.
809069|NCT01364207|E1|Reported Event|Caffeinated Coffee|Participants drank an 8 oz cup of caffeinated coffee.
809070|NCT01363986|B1|Baseline|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
809136|NCT01363700|B4|Baseline|Total|Total of all reporting groups
811237|NCT01357239|O1|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
809073|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
809074|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
809075|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
809076|NCT01363986|O1|Outcome|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
809077|NCT01363986|E1|Reported Event|Trastuzumab Monotherapy|Participants received an initial loading dose of 4 mg/kg trastuzumab i.v. on Day 1, followed by doses of 2 mg/kg trastuzumab i.v. once weekly for up to 18 weeks.
809078|NCT01363908|B3|Baseline|Total|Total of all reporting groups
809079|NCT01363908|B2|Baseline|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809080|NCT01363908|B1|Baseline|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809081|NCT01363908|P2|Participant Flow|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809082|NCT01363908|P1|Participant Flow|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809083|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809084|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809085|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809086|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809087|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809088|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809089|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809090|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809091|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809092|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809093|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
812001|NCT01353976|P1|Participant Flow|Econazole Nitrate Foam 1%|Study medication
809094|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809095|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809096|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809097|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809098|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809099|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809100|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809101|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809102|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809103|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809104|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809105|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809106|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809107|NCT01363908|O2|Outcome|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809108|NCT01363908|O1|Outcome|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809109|NCT01363908|E2|Reported Event|12 to <18 Year Old|During the pharmacokinetic phase, participants aged 12 to less than 18 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809110|NCT01363908|E1|Reported Event|6 to <12 Year Old|During the pharmacokinetic phase, participants aged 6 to less than 12 years received a single oral dose of SPD602 16mg/kg. During the chronic dosing phase, participants commenced 48 weeks of treatment with an initial dose of SPD602 26mg/kg/day or 36mg/kg/day. Over the course of treatment, the dose could range from 8-60mg/kg/day depending on clinical response.
809137|NCT01363700|B3|Baseline|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
809138|NCT01363700|B2|Baseline|Epinastine / Epinastine Period1|Epinastine / Epinastine : DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
809372|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
809111|NCT01363843|B1|Baseline|Study Arm|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
809112|NCT01363843|P1|Participant Flow|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
809113|NCT01363843|O1|Outcome|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV, followed by 5-FU 400 mg/m2 IV, followed 5-FU 2400 mg/m2 IV by continuous infusion over 46 hours - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion starting the morning of the first dose of radiation and ending the morning after the last dose of radiation~Capecitabine 825 mg/m2 PO BID~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
809114|NCT01363843|E1|Reported Event|Study Arm Only|"Induction therapy - Modified FOLFOX6 - Repeat q14 days x 8 cycles~Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~50.4 Gy Radiation in 28 fractions (45 Gy IMRT, 5.4 Gy 3D conformal boost)~Study Arm only (modified FOLFOX6): Induction;FOLFOX6 - Oxaliplatin 85 mg/m2 + Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV followed 5-FU 2400 mg/m2 IV by continuous over 46 hours q 14 days x 8 cycles Concurrent Chemoradiation with either continuous infusion 5-FU or capecitabine (MD choice)~5-FU 225 mg/m2 by continuous infusion(typical week of treatment is Monday AM thru Saturday AM = 1125 mg/m2/week)~Capecitabine"
809115|NCT01363765|B3|Baseline|Total|Total of all reporting groups
809116|NCT01363765|B2|Baseline|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
809117|NCT01363765|B1|Baseline|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
809118|NCT01363765|P2|Participant Flow|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
809119|NCT01363765|P1|Participant Flow|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
809120|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
809121|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
809122|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
809123|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
809124|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining
809125|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period were submitted to this technology instead, a real-time automated polymerase chain reaction test
809126|NCT01363765|O2|Outcome|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine smear staining
809127|NCT01363765|O1|Outcome|Xpert MTB/Rif|One sample of sputum specimens arriving during intervention period was submitted to this technology
809128|NCT01363765|E2|Reported Event|Sputum Smear|Sputum smears arriving in the laboratory during the observation period were submitted to the classic routine AFB smear staining, as per national guidelines. Two smears were requested.
809129|NCT01363765|E1|Reported Event|Xpert MTB/Rif|Sputum specimens arriving during intervention period were submitted to this technology, a real-time automated polymerase chain reaction test
809130|NCT01363713|B1|Baseline|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
809131|NCT01363713|P1|Participant Flow|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
809132|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
809133|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
809134|NCT01363713|O1|Outcome|DE-114 Ophthalmic Solution|DE-114 ophthalmic solution. One drop at a time, 4 times-daily dosing, bilateral topical instillation. A single arm study.
809139|NCT01363700|B1|Baseline|Epinastine / Placebo Period1|Epinastine / Placebo : DE-114 ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
809140|NCT01363700|P5|Participant Flow|Epinastine / Placebo Period2|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
809141|NCT01363700|P4|Participant Flow|Olopatadine / Placebo Period2|Olopatadine / Placebo : Olopatadine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
809142|NCT01363700|P3|Participant Flow|Placebo / Placebo Period1|Placebo / Placebo : vehicle of DE-114 ophthalmic solution, 1 drop in each eye at designated visits.
809143|NCT01363700|P2|Participant Flow|Epinastine / Epinastine Period1|Epinastine / Epinastine : Epinastine ophthalmic solution, 1 drop in each eye at designated visits.
809144|NCT01363700|P1|Participant Flow|Epinastine / Placebo Period1|Epinastine / Placebo : Epinastine ophthalmic solution in one eye and vehicle of DE-114 ophthalmic solution in the other eye, Both eye received 1 drop at designated visits.
809145|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
809146|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
809147|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
809148|NCT01363700|O3|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
809149|NCT01363700|O2|Outcome|Olopatadine Ophthalmic Solution|Count unit was defined each eye.
809150|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
809151|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
809152|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
809153|NCT01363700|O2|Outcome|Placebo Ophthalmic Solution|Count unit was defined each eye.
809154|NCT01363700|O1|Outcome|Epinastine (DE-114) Ophthalmic Solution|Count unit was defined each eye.
809155|NCT01363700|E5|Reported Event|Placebo Ophthalmic Solution Period2|Count unit was defined each eye.
809156|NCT01363700|E4|Reported Event|Olopatadine Ophthalmic Solution Period2|Count unit was defined each eye.
809157|NCT01363700|E3|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period2|Count unit was defined each eye.
809158|NCT01363700|E2|Reported Event|Placebo Ophthalmic Solution Period1|Count unit was defined each eye.
809159|NCT01363700|E1|Reported Event|Epinastine (DE-114) Ophthalmic Solution Period1|Count unit was defined each eye.
809160|NCT01363661|B3|Baseline|Total|Total of all reporting groups
809161|NCT01363661|B2|Baseline|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809162|NCT01363661|B1|Baseline|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809163|NCT01363661|P2|Participant Flow|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809164|NCT01363661|P1|Participant Flow|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809165|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809166|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809167|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809168|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809169|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809170|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809171|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809172|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809173|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809174|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809175|NCT01363661|O2|Outcome|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809176|NCT01363661|O1|Outcome|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809177|NCT01363661|E2|Reported Event|Placebo|"Placebo (16 mg tablet; once a day)~Placebo: Placebo (16 mg tablet, per os; once-daily)"
809178|NCT01363661|E1|Reported Event|Molsidomine|"Coruno (molsidomine 16 mg tablet; per os; once daily)~Coruno: Molsidomine 16 mg tablet, per os, once a day"
809179|NCT01363492|B1|Baseline|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809180|NCT01363492|P1|Participant Flow|Replagal® (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes every other week (EOW)
809181|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809182|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809183|NCT01363492|O1|Outcome|Replagal 0.2 mg/kg|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809184|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809185|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809186|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809187|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809188|NCT01363492|O1|Outcome|Replagal (0.2 mg/kg)|0.2 mg/kg Replagal (agalsidase alfa) administered over 40 minutes EOW
809193|NCT01363479|B2|Baseline|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
809194|NCT01363479|B1|Baseline|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
809195|NCT01363479|P2|Participant Flow|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
809196|NCT01363479|P1|Participant Flow|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
809197|NCT01363479|O2|Outcome|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
809198|NCT01363479|O1|Outcome|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
809199|NCT01363479|E2|Reported Event|I.V. Palonosetron Plus Dexamethasone|"Intravenous palonosetron (Aloxi 0.25 mg solution for injection) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~I.V. palonosetron~Dexamethasone"
809200|NCT01363479|E1|Reported Event|Oral Palonosteron Plus Dexamethasone|"Oral palonosetron (Aloxi 0.50 mg softgel capsule) with oral dexamethasone, both given on Day 1, prior to the scheduled start of cisplatin; then dexamethasone from Days 2 through 4.~Oral palonosetron~Dexamethasone"
809201|NCT01363440|B4|Baseline|Total|Total of all reporting groups
809202|NCT01363440|B3|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809203|NCT01363440|B2|Baseline|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809204|NCT01363440|B1|Baseline|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809205|NCT01363440|P3|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809206|NCT01363440|P2|Participant Flow|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809207|NCT01363440|P1|Participant Flow|Macular Laser Photocoagulation Treatment (Control)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809208|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809209|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809210|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809211|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809212|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809213|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809214|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809215|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809216|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809217|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809218|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809219|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809220|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809221|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809222|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809223|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809224|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809225|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809226|NCT01363440|O3|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809227|NCT01363440|O2|Outcome|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321) 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809228|NCT01363440|O1|Outcome|Control|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809229|NCT01363440|E6|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809230|NCT01363440|E5|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 148)|Participants received 2mg Intravitreal aflibercept injection(IAI) every 4 weeks.
809231|NCT01363440|E4|Reported Event|Control (Week 0 to Week 148)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809232|NCT01363440|E3|Reported Event|IAI;EYLEA®;BAY86-5321) 2Q8 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks for 5 visits followed by injections every 8 weeks.
809233|NCT01363440|E2|Reported Event|IAI;EYLEA®;BAY86-5321 2Q4 (Week 0 to Week 100)|Participants received 2mg Intravitreal aflibercept injection (IAI) every 4 weeks.
809234|NCT01363440|E1|Reported Event|Control (Week 0 to Week 100)|Participants received macular laser treatment at baseline and as-needed at visits at which laser re-treatment criteria were met, but no more frequently than every 12 weeks.
809235|NCT01363401|B3|Baseline|Total|Total of all reporting groups
809236|NCT01363401|B2|Baseline|No Treatment|"No treatment with HYNR-CS inj.~Take each 50mg 1 hour before a meal or 2 hours after a meal at least at an interval of 12 hours, 28 weeks(12 weeks of run-in phase plus 16 weeks of treatment phase)"
809237|NCT01363401|B1|Baseline|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
809238|NCT01363401|P2|Participant Flow|No Treatment|No treatment with HYNR-CS inj.
809239|NCT01363401|P1|Participant Flow|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
809240|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
809241|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
809242|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
809243|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
809244|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
809245|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
809246|NCT01363401|O2|Outcome|No Treatment|No treatment with HYNR-CS inj.
809247|NCT01363401|O1|Outcome|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
809248|NCT01363401|E2|Reported Event|No Treatment|No treatment with HYNR-CS inj.
809249|NCT01363401|E1|Reported Event|HYNR-CS Inj.|"Treatment group with HYNR-CS inj.~intrathecal injection with 1ml/10kg of body weight administer twice at an interval of 26day."
809250|NCT01363349|B3|Baseline|Total|Total of all reporting groups
809251|NCT01363349|B2|Baseline|Risperidone|"2-6 mg, 6 months~Risperidone"
809252|NCT01363349|B1|Baseline|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
809253|NCT01363349|P2|Participant Flow|Risperidone|"2-6 mg, 6 months~Risperidone"
809254|NCT01363349|P1|Participant Flow|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
809255|NCT01363349|O2|Outcome|Risperidone|"2-6 mg, 6 months~Risperidone"
809256|NCT01363349|O1|Outcome|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
809257|NCT01363349|E2|Reported Event|Risperidone|"2-6 mg, 6 months~Risperidone"
809258|NCT01363349|E1|Reported Event|CYP-1020|CYP-1020: CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
809259|NCT01363297|B6|Baseline|Total|Total of all reporting groups
809260|NCT01363297|B5|Baseline|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809261|NCT01363297|B4|Baseline|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809262|NCT01363297|B3|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809263|NCT01363297|B2|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809264|NCT01363297|B1|Baseline|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809265|NCT01363297|P5|Participant Flow|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809266|NCT01363297|P4|Participant Flow|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809373|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
809267|NCT01363297|P3|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809268|NCT01363297|P2|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809269|NCT01363297|P1|Participant Flow|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809270|NCT01363297|O1|Outcome|Pharmacogenomics Population|All participants who gave consent for the optional blood sample for pharmacogenomic analyses, received at least 1 dose of any study drug, and had at least 1 biomarker parameter from the corresponding assay sample with both a baseline and post-treatment assessment.
809271|NCT01363297|O6|Outcome|All Doses|
809272|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809273|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809274|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809275|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809276|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809277|NCT01363297|O6|Outcome|All Doses|
809278|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809279|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809280|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809281|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809282|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809283|NCT01363297|O6|Outcome|All Doses|
809284|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809285|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809286|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809287|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809288|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809289|NCT01363297|O6|Outcome|All Doses|
809290|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809291|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809292|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809293|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809294|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809295|NCT01363297|O6|Outcome|All Doses|
809296|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809297|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809298|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809299|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809498|NCT01362686|B4|Baseline|Total|Total of all reporting groups
809300|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809301|NCT01363297|O6|Outcome|All Doses|
809302|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809303|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809304|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809305|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809306|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809307|NCT01363297|O6|Outcome|All Doses|
809308|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809309|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809310|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809311|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809312|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809313|NCT01363297|O6|Outcome|All Doses|
809314|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809315|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809316|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809317|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809318|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809319|NCT01363297|O6|Outcome|All Doses|
809320|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809321|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809322|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809323|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809324|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809325|NCT01363297|O6|Outcome|All Doses|
809326|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809327|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809328|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809329|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809330|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809331|NCT01363297|O6|Outcome|All Doses|
809332|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809333|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809556|NCT01362530|B3|Baseline|Total|Total of all reporting groups
809334|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809335|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809336|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809337|NCT01363297|O1|Outcome|All Doses|
809338|NCT01363297|O6|Outcome|All Doses|
809339|NCT01363297|O5|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809340|NCT01363297|O4|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809341|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809342|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809343|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809344|NCT01363297|O1|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809345|NCT01363297|O1|Outcome|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809346|NCT01363297|O1|Outcome|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809347|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809348|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809349|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809350|NCT01363297|O3|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809351|NCT01363297|O2|Outcome|Phase 1 - Dose Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809352|NCT01363297|O1|Outcome|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809353|NCT01363297|E5|Reported Event|Phase 2: IV Inotuzumab Ozogamicin 1.8mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809354|NCT01363297|E4|Reported Event|Phase 1 - Expansion Phase: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809355|NCT01363297|E3|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.8 mg/m^2|IV inotuzumab ozogamicin 1.8 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.5 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809356|NCT01363297|E2|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.6 mg/m^2|IV inotuzumab ozogamicin 1.6 mg/m^2 given in 3 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Days 8 and 15) for a maximum of 6 cycles
809357|NCT01363297|E1|Reported Event|Phase 1 - Dose-Finding: IV Inotuzumab Ozogamicin 1.2 mg/m^2|IV inotuzumab ozogamicin 1.2 mg/m^2 given in 2 doses over a 28-day cycle (0.8 mg/m^2 on Day 1 and 0.4 mg/m^2 on Day 15) for a maximum of 6 cycles
809358|NCT01363076|B3|Baseline|Total|Total of all reporting groups
809359|NCT01363076|B2|Baseline|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
809360|NCT01363076|B1|Baseline|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
809361|NCT01363076|P2|Participant Flow|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
809362|NCT01363076|P1|Participant Flow|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
809363|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
809364|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
809365|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
809366|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
809367|NCT01363076|O2|Outcome|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
809368|NCT01363076|O1|Outcome|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
812002|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
809377|NCT01363076|E2|Reported Event|Ketorolac Tromethamine (30 mg)|Single intranasal (IN) dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
809378|NCT01363076|E1|Reported Event|Ketorolac Tromethamine (15 mg)|Single intranasal (IN) dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
809379|NCT01363050|B1|Baseline|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809380|NCT01363050|P1|Participant Flow|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809381|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809382|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809383|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809384|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809385|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809386|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 3): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809387|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1): Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809388|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809389|NCT01363050|O1|Outcome|Ketorolac Tromethamine|Ketorolac tromethamine (Day 1) : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809390|NCT01363050|E1|Reported Event|Ketorolac Tromethamine|Ketorolac tromethamine : Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
809391|NCT01363011|B3|Baseline|Total|Total of all reporting groups
809392|NCT01363011|B2|Baseline|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809393|NCT01363011|B1|Baseline|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809394|NCT01363011|P2|Participant Flow|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to cobicistat (Tybost®; COBI) 150 mg, while continuing the other components of their ARV regimen (atazanavir (ATV) 300 mg or darunavir (DRV) 800 mg plus 2 nucleoside reverse transcriptase inhibitors (NRTI)) for up to 96 weeks. These 2 NRTIs may have included abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or emtricitabine/tenofovir disoproxil fumarate (Truvada®; FTC/TDF), administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809395|NCT01363011|P1|Participant Flow|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior antiretroviral (ARV) treatment and who were virologically unsuppressed at baseline initiated treatment with elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild®; E/C/F/TDF) (150/150/200/300 mg) single-tablet regimen (STR) once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809396|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809952|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809397|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809398|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809399|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809400|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809401|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809402|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809403|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809404|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809405|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809406|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809407|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809408|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809409|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809713|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809410|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809411|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809412|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809413|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809414|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809415|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809416|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809417|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809418|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809419|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809420|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809421|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809422|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809423|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809574|NCT01362517|O1|Outcome|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
809575|NCT01362517|O1|Outcome|Quinvaxem|
809424|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809425|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809426|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809427|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809428|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809429|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809430|NCT01363011|O1|Outcome|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTIs) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809431|NCT01363011|O1|Outcome|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809432|NCT01363011|E2|Reported Event|COBI+PI+2 NRTIs (Cohort 2)|"Main Study: Participants who had received prior ARV treatment and who were virologically suppressed at baseline switched their regimen's pharmacoenhancer component from ritonavir to COBI 150 mg, while continuing the other components of their ARV regimen (ATV 300 mg or DRV 800 mg plus 2 NRTI) for up to 96 weeks. These 2 NRTIs may have included ABC, 3TC/ZDV, DDI, FTC, ABC/3TC, 3TC, TDF, or FTC/TDF, administered according to prescribing information.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of cobicistat was received in the applicable country."
809433|NCT01363011|E1|Reported Event|E/C/F/TDF (Cohort 1)|"Main Study: Participants who had not received prior ARV treatment and who were virologically unsuppressed at baseline initiated treatment with E/C/F/TDF (150/150/200/300 mg) STR once daily for up to 96 weeks.~Extension Phase: Participants continued their treatment until all participants discontinued from the study or commercial approval of E/C/F/TDF was received in the applicable country."
809434|NCT01362946|B1|Baseline|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809435|NCT01362946|P2|Participant Flow|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
809436|NCT01362946|P1|Participant Flow|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
809573|NCT01362517|P1|Participant Flow|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
812003|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
809437|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
809438|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons.
809439|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809440|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809441|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809442|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809443|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809444|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809445|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809446|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809447|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809448|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809449|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809755|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809450|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809451|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809452|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809453|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809454|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809455|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809456|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809457|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809458|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809459|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809460|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809461|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809462|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
812004|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
809463|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809464|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809465|NCT01362946|O1|Outcome|Overall Sample|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During one block of four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During another block of four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. Order of treatment blocks was counter-balanced across participants, and primary analyses were within-subject comparisons. Therefore, we report demographics for the full sample.
809466|NCT01362946|E2|Reported Event|Standard Behavior Treatment Then Modified Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment. During the last four weeks of treatment, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments.
809467|NCT01362946|E1|Reported Event|Modified Behavior Treatment Then Standard Behavior Treatment|Summer treatment program: Intensive behavioral treatment delivered in a summer camp setting. During the first four weeks, participants received modified behavioral treatment (MBT) that emphasized rewards and de-emphasized punishments. During the last four weeks, participants received standard behavior treatment (SBT) that balanced reward and punishment.
809468|NCT01362907|B1|Baseline|Overall|All enrolled participants
809469|NCT01362907|P2|Participant Flow|Etafilcon A / Delefilcon A|Etafilcon A contact lenses worn first, with delefilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
809470|NCT01362907|P1|Participant Flow|Delefilcon A / Etafilcon A|Delefilcon A contact lenses worn first, with etafilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
809471|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809472|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809473|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809474|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809475|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809476|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809477|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809478|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809479|NCT01362907|O2|Outcome|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809480|NCT01362907|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809481|NCT01362907|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809482|NCT01362907|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809483|NCT01362894|B1|Baseline|Overall|All enrolled and dispensed participants.
809484|NCT01362894|P2|Participant Flow|Etafilcon A / Nelfilcon A|Etafilcon A lenses worn first, with nelfilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
809485|NCT01362894|P1|Participant Flow|Nelfilcon A / Etafilcon A|Nelfilcon A lenses worn first, with etafilcon A lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
809486|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809487|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809488|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809489|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809490|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809491|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809492|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809493|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809494|NCT01362894|O2|Outcome|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809495|NCT01362894|O1|Outcome|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809496|NCT01362894|E2|Reported Event|Etafilcon A|Etafilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809497|NCT01362894|E1|Reported Event|Nelfilcon A|Nelfilcon A lenses worn bilaterally on a daily wear, daily disposable basis for one week.
809499|NCT01362686|B3|Baseline|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809500|NCT01362686|B2|Baseline|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809501|NCT01362686|B1|Baseline|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809502|NCT01362686|P3|Participant Flow|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809503|NCT01362686|P2|Participant Flow|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809504|NCT01362686|P1|Participant Flow|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809505|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809506|NCT01362686|O2|Outcome|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809507|NCT01362686|O1|Outcome|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809508|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809509|NCT01362686|O2|Outcome|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809510|NCT01362686|O1|Outcome|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809511|NCT01362686|O3|Outcome|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809512|NCT01362686|O2|Outcome|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809513|NCT01362686|O1|Outcome|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
812005|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
809514|NCT01362686|E3|Reported Event|Rivastigmine|"See intervention note.~Rivastigmine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809515|NCT01362686|E2|Reported Event|Galantamine|"See intervention note.~Galantamine: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809516|NCT01362686|E1|Reported Event|Donepezil|"See intervention note.~Donepezil: The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care."
809517|NCT01362608|B3|Baseline|Total|Total of all reporting groups
809518|NCT01362608|B2|Baseline|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809519|NCT01362608|B1|Baseline|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809520|NCT01362608|P2|Participant Flow|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809521|NCT01362608|P1|Participant Flow|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809522|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809523|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809524|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809525|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809526|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809527|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809528|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809529|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809530|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809531|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809532|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809533|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809534|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809535|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809536|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809537|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809538|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809539|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809540|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809541|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809542|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809543|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809544|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809545|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809546|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809547|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809548|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809549|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809550|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809551|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809552|NCT01362608|O2|Outcome|Triamcinolone Acetonide 40 mg|triamcinolone acetonide 40 mg i.m. and matching placebo for canakinumab s.c.
809553|NCT01362608|O1|Outcome|ACZ885 150 mg|Patients were treated with canakinumab 150 mg s.c and matching placebo for triamcinolone acetonide i.m.
809554|NCT01362608|E2|Reported Event|Triam 40mg im|Triam 40mg im
809555|NCT01362608|E1|Reported Event|ACZ885 150mg sc|ACZ885 150mg sc
809557|NCT01362530|B2|Baseline|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809558|NCT01362530|B1|Baseline|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809559|NCT01362530|P2|Participant Flow|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809560|NCT01362530|P1|Participant Flow|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809561|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809562|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809563|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809564|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809565|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809566|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809567|NCT01362530|O2|Outcome|Control Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809568|NCT01362530|O1|Outcome|Aprepitant Regimen|Cycle 1: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg). Optional Cycles 2-6: Open-label aprepitant administered in the same manner as in Cycle 1.
809569|NCT01362530|E3|Reported Event|Aprepitant Regimen Cycles 2-6|Participants completing Cycle 1 from either the aprepitant or the control regimen who meet eligibility criteria: Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
809570|NCT01362530|E2|Reported Event|Control Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: matching placebo for aprepitant 125 mg capsule oral (PO) + ondansetron Days 2 to 3: matching placebo for aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: matching placebo PFS: 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: matching placebo PFS: 2.0 mg/kg (up to 80 mg).
809571|NCT01362530|E1|Reported Event|Aprepitant Regimen Cycle 1|Participants 12 to 17 years of age, Day 1: aprepitant 125 mg capsule orally (PO) + ondansetron, Days 2 to 3: aprepitant 80 mg capsule PO. Participants 6 months to <12 years of age, Day 1: aprepitant powder for suspension (PFS), 3.0 mg/kg (up to 125 mg) + ondansetron, Days 2 to 3: aprepitant PFS, 2.0 mg/kg (up to 80 mg).
809572|NCT01362517|B1|Baseline|Quinvaxem|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose of Quinvaxem given at 2, 3 and 4 months of age"
809803|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809577|NCT01362517|E3|Reported Event|Third Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 4 months of age"
809578|NCT01362517|E2|Reported Event|Second Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 3 months of age"
809579|NCT01362517|E1|Reported Event|First Dose|"Quinvaxem : A single dose (0.5 mL) of Quinvaxem contains:~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen~One dose given at 2 months of age"
809580|NCT01362491|B4|Baseline|Total|Total of all reporting groups
809581|NCT01362491|B3|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809582|NCT01362491|B2|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809583|NCT01362491|B1|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809584|NCT01362491|P3|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809585|NCT01362491|P2|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809586|NCT01362491|P1|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809587|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809588|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809589|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809590|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809591|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809592|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809593|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809594|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809595|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809596|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809597|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809598|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809599|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809600|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809601|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809602|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809603|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809710|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809604|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809605|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809606|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809607|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809608|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809609|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809610|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809611|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809612|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809613|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809614|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809615|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809616|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809617|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809618|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809619|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809620|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809621|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809622|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809623|NCT01362491|O3|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809624|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809625|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809626|NCT01362491|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809627|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809628|NCT01362491|O2|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809629|NCT01362491|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809630|NCT01362491|E3|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809631|NCT01362491|E2|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
809632|NCT01362491|E1|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
809633|NCT01362439|B1|Baseline|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
812006|NCT01353976|O2|Outcome|Vehicle Foam|Placebo medication
809634|NCT01362439|P1|Participant Flow|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809757|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809635|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809636|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809637|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809638|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809639|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809640|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809641|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809642|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809643|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809644|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809645|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone ER tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 mg for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809646|NCT01362439|O1|Outcome|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809647|NCT01362439|E1|Reported Event|Paliperidone ER|Participants were administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose was increased or decreased as per Investigator's discretion.
809648|NCT01362296|B3|Baseline|Total|Total of all reporting groups
809649|NCT01362296|B2|Baseline|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809650|NCT01362296|B1|Baseline|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809651|NCT01362296|P4|Participant Flow|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809652|NCT01362296|P3|Participant Flow|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809653|NCT01362296|P2|Participant Flow|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809654|NCT01362296|P1|Participant Flow|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809655|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809714|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
812316|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
809656|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809657|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809658|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809659|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809660|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809661|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809662|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809663|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809664|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809665|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809666|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809667|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809668|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809669|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809670|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809711|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809671|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809672|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809673|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809674|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809675|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809676|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809677|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809678|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809679|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809680|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809681|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809682|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809683|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809684|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809685|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809712|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809686|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809687|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809688|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809689|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in CP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809690|NCT01362296|O1|Outcome|GSK1120212 2 mg in CP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809691|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809692|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809693|NCT01362296|O2|Outcome|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (GSK1120212 2 mg), and continuing in the CP.
809694|NCT01362296|O1|Outcome|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced. Participants who experienced disease progression in the RP were given the option of crossing over to the alternative treatment arm (docetaxel 75 milligrams per meters squared [mg/m^2]), and continuing in the Cross-over Phase (CP).
809695|NCT01362296|E4|Reported Event|Docetaxel 75 mg/m^2 in CP|Participants who experienced disease progression in the RP were given the option of crossing over to docetaxel 75 mg/m^2 and continuing in the CP.
809696|NCT01362296|E3|Reported Event|GSK1120212 2 mg in CP|Participants who experienced disease progression in the RP were given the option of crossing over to GSK1120212 2 mg and continuing in the Cross-over Phase (CP).
809697|NCT01362296|E2|Reported Event|Docetaxel 75 mg/m^2 in RP|Participants received docetaxel 75 mg per meters squared (m^2) intravenously (IV) every 3 weeks in the RP. Participants continued treatment on a 21-day cycle until disease progression, death, or unacceptable adverse events were experienced.
809698|NCT01362296|E1|Reported Event|GSK1120212 2 mg in RP|Participants received GSK1120212 2 milligrams (mg) orally once daily continuously in the Randomized Phase (RP). Participants continued treatment until disease progression, death, or unacceptable adverse events were experienced.
809699|NCT01362244|B3|Baseline|Total|Total of all reporting groups
809700|NCT01362244|B2|Baseline|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809701|NCT01362244|B1|Baseline|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
809702|NCT01362244|P2|Participant Flow|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809703|NCT01362244|P1|Participant Flow|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809704|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809705|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809706|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809707|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809708|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809709|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
812007|NCT01353976|O1|Outcome|Econazole Nitrate Foam 1%|Study medication
809715|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809716|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809717|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809718|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809719|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809720|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809721|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809722|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809723|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809724|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809725|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809726|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809727|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809728|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809729|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809730|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809731|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809732|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809733|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809734|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809735|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809736|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809737|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809738|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809739|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809740|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809741|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809742|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809743|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809744|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809745|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809746|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809747|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809748|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809749|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809750|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809751|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809752|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809753|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809754|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809756|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809758|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809759|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809760|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809761|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809762|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809763|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809764|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809765|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809766|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809767|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809768|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809769|NCT01362244|O2|Outcome|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809770|NCT01362244|O1|Outcome|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion.
809771|NCT01362244|E2|Reported Event|Placebo|Participants received up to a total of six doses (one every 4 weeks) of matching placebo by intravenous infusion.
809772|NCT01362244|E1|Reported Event|Mepolizumab 750 mg|Participants received up to a total of six doses (one every 4 weeks) of mepolizumab 750 milligrams (mg) by intravenous infusion
809773|NCT01362192|B1|Baseline|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809774|NCT01362192|P1|Participant Flow|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809775|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809776|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809777|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809778|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809779|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809780|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809781|NCT01362192|O1|Outcome|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809782|NCT01362192|E1|Reported Event|532 nm KTP Laser Treatment|Each subject will receive 532 nm KTP laser treatment for their lower extremity spider veins
809783|NCT01362140|B3|Baseline|Total|Total of all reporting groups
809784|NCT01362140|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809785|NCT01362140|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809786|NCT01362140|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809787|NCT01362140|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809788|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809789|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809790|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809791|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809792|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809793|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809794|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809795|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809796|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809797|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809798|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809799|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809800|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809801|NCT01362140|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 3 weeks (Q3W) for 24 weeks.
809802|NCT01362140|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa 500 µg Q3W for 24 weeks.
809809|NCT01362062|B2|Baseline|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
809810|NCT01362062|B1|Baseline|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809811|NCT01362062|P2|Participant Flow|RA Cohort (Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed retrospectively for a total duration of 12 months.
809812|NCT01362062|P1|Participant Flow|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic disease modifying anti-rheumatoid drug (DMARD) and/or anti-tumor necrosis factor (anti-TNF) therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809813|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809814|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809815|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809816|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809817|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809818|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809819|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809820|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809821|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809822|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809823|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809824|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809825|NCT01362062|O1|Outcome|RA Cohort (Prospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively for a total duration of 12 months.
809826|NCT01362062|O1|Outcome|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
809827|NCT01362062|E1|Reported Event|RA Cohort (Prospective + Retrospective)|Participants with active RA who had an inadequate clinical response to current non-biologic DMARD and/or anti-TNF therapy being treated with tocilizumab according to the routine clinical practice and in line with prescribing information were observed prospectively or retrospectively for a total duration of 12 months.
809828|NCT01362049|B5|Baseline|Total|Total of all reporting groups
809829|NCT01362049|B4|Baseline|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
809953|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809830|NCT01362049|B3|Baseline|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received MSI-match treatment"
813076|NCT01350115|P2|Participant Flow|Placebo|Participants received matching placebo.
809831|NCT01362049|B2|Baseline|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
809832|NCT01362049|B1|Baseline|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-match treatment"
809833|NCT01362049|P4|Participant Flow|'Ineligible' Subject Group – STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
809834|NCT01362049|P3|Participant Flow|'Ineligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received MSI- matched treatment"
809835|NCT01362049|P2|Participant Flow|'Eligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
809836|NCT01362049|P1|Participant Flow|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI match treatment"
809837|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809838|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
809839|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809840|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
809841|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809842|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
809843|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809844|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
809858|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
809922|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809845|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809846|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises
809847|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809848|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
809849|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809850|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises
809851|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809852|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
809853|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809854|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
809855|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809856|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
809857|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809859|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809860|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises
809861|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809862|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises.
809863|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809864|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises.
809865|NCT01362049|O4|Outcome|'Ineligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809866|NCT01362049|O3|Outcome|'Ineligible' Subject Group -MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria and who received MSI exercises for treatment.
809867|NCT01362049|O2|Outcome|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level.~Physical Therapy rehabilitation: Stabilization exercises.: The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions."
809868|NCT01362049|O1|Outcome|'Eligible' Subject Group - MSI|Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria and who received MSI exercises for treatment
809869|NCT01362049|E4|Reported Event|'Ineligible' Subject Group - STAB Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria.~Received STAB treatment"
809870|NCT01362049|E3|Reported Event|'Ineligible' Subject Group - MSI Treatment|Subjects between the ages of 21-55 years with low back pain >12 months who are not eligible for the TBC-based stabilization exercises based on current criteria Received MSI-matched treatment
809871|NCT01362049|E2|Reported Event|'Eligible' Subject Group - STAB|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received STAB treatment"
809872|NCT01362049|E1|Reported Event|'Eligible' Subject Group - MSI Treatment|"Subjects between the ages of 21-55 years with low back pain >12 months who are eligible for Treatment-Based Classification (TBC) stabilization exercises based on current criteria:~straight leg raise > 90 degrees~aberrant trunk movement with trunk forward flexion~positive prone instability test AND/OR~passive lumbar mobility testing that is judged to be hypermobile at any level. Received MSI-matched treatment"
809950|NCT01360632|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks.
812008|NCT01353976|E2|Reported Event|Vehicle Foam|Placebo medication
809873|NCT01361867|B1|Baseline|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
809874|NCT01361867|P1|Participant Flow|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
809875|NCT01361867|O1|Outcome|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
809876|NCT01361867|O1|Outcome|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
809877|NCT01361867|E1|Reported Event|Robot-induced Perturbations|"The subject walks on a treadmill with his/her legs strapped to a robotic system (Lokomat by Hocoma AG) that generates mechanical perturbations aimed to modify the subject's walking pattern.~Robot-induced perturbations: A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations."
809878|NCT01361854|B1|Baseline|Polysomnography for Suspicion of SDB|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed ar at home or in the hospital"
809879|NCT01361854|P2|Participant Flow|Hospital Hook-up First, Then Home Hook-up|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at the hospital Croosover design. 2nd polysomnography with home hook-up performed within 2 weeks"
809880|NCT01361854|P1|Participant Flow|Home Hook-up First Then Hook-up in the Hospital|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home first.~Croosover design. 2nd polysomnography with in-lab hook-up performed within 2 weeks"
809881|NCT01361854|O2|Outcome|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography:home polysomnography with in-lab hook up first"
809882|NCT01361854|O1|Outcome|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with home hook-up first"
809883|NCT01361854|E2|Reported Event|Lab Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed in the sleep lab"
809884|NCT01361854|E1|Reported Event|Home Hook up First|"adults, suspects of suffering from sleep disordered-breathing, who must undergo a diagnostic polysomnography~polysomnography: home-based polysomnography with hook-up performed at home"
809885|NCT01360645|B3|Baseline|Total|Total of all reporting groups
809886|NCT01360645|B2|Baseline|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809887|NCT01360645|B1|Baseline|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809888|NCT01360645|P4|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
809889|NCT01360645|P3|Participant Flow|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809890|NCT01360645|P2|Participant Flow|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809891|NCT01360645|P1|Participant Flow|Single-blind Placebo + ADT|In Phase A, participants were administered placebo as an adjunctive therapy to an open label ADT for 8 weeks
809892|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809893|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809894|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809895|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809896|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809951|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809897|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809898|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809899|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809900|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809901|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809902|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809903|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809904|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809905|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809906|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809907|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809908|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809909|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809910|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809911|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809912|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809913|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809914|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809915|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809916|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809917|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809918|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809919|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809920|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809921|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809923|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809924|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809925|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809926|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809927|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809928|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809929|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809930|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809931|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809932|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809933|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809934|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809935|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809936|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809937|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809938|NCT01360645|O2|Outcome|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809939|NCT01360645|O1|Outcome|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809940|NCT01360645|E2|Reported Event|Double-blind Placebo + ADT|Participants received placebo as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809941|NCT01360645|E1|Reported Event|Brexpiprazole 2 mg/Day + ADT|Participants received Brexpiprazole 2 mg/day as an adjunctive therapy over a 2-week period beginning at the Week 8 visit and continued to take the same ADT that was assigned in Phase A at the final dose taken just prior to the Week 8 visit.
809942|NCT01360632|B4|Baseline|Total|Total of all reporting groups
809943|NCT01360632|B3|Baseline|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
809944|NCT01360632|B2|Baseline|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
809945|NCT01360632|B1|Baseline|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
809946|NCT01360632|P5|Participant Flow|Phase A+ Placebo + ADT|Participants who did not meet criteria for randomization and a follow-up of 30 (+2) days after the last dose of study medication were in Phase A+
809947|NCT01360632|P4|Participant Flow|Double-blind Placebo + ADT|In phase B, participants were administered placebo as an adjunctive therapy to an open label ADT for 6 weeks.
809948|NCT01360632|P3|Participant Flow|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
809949|NCT01360632|P2|Participant Flow|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole of [1mg (milligram)] as an adjunctive therapy to an assigned open-label ADT (anti-depressant therapy).
812009|NCT01353976|E1|Reported Event|Econazole Nitrate Foam 1%|Study medication
809954|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810946|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
809955|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809956|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809957|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809958|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809959|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809960|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809961|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809962|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809963|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809964|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809965|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809966|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809967|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809968|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809969|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809970|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809971|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809972|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809973|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809974|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809975|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809976|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809977|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809978|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809979|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809980|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809981|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809982|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809983|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809984|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809985|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809986|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809987|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809988|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809989|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809990|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809991|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809992|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809993|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809994|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
809995|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809996|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
809997|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
811240|NCT01357239|E2|Reported Event|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
809998|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
809999|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810000|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810001|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810002|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810003|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810004|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810005|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810006|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810007|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810008|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810009|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810010|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810011|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810012|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810013|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810014|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810015|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810016|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810017|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810018|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810019|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810020|NCT01360632|O3|Outcome|Placebo + ADT|Participants were administered placebo daily as an adjunctive therapy to an open label ADT.
810021|NCT01360632|O2|Outcome|Brexpiprazole (3mg) + ADT|Participants were administered brexpiprazole 3mg/day as an adjunctive therapy to an assigned open-label ADT.
810022|NCT01360632|O1|Outcome|Brexpiprazole (1mg) + ADT|Participants were administered brexpiprazole 1mg/day as an adjunctive therapy to an assigned open-label ADT.
810023|NCT01360632|E3|Reported Event|Placebo + ADT|Participants were administered placebo as an adjunctive therapy to an open label ADT.
810024|NCT01360632|E2|Reported Event|Brexpiprazole (3mg + ADT)|Participants were administered brexpiprazole of 3mg as an adjunctive therapy to an assigned open-label ADT.
810025|NCT01360632|E1|Reported Event|Brexpiprazole (1mg + ADT)|Participants were administered brexpiprazole of 1mg as an adjunctive therapy to an assigned open-label ADT.
810026|NCT01361633|B3|Baseline|Total|Total of all reporting groups
810027|NCT01361633|B2|Baseline|Sugar Pill|Placebo Control
810028|NCT01361633|B1|Baseline|Medication|250 mg d-cycloserine
810029|NCT01361633|P2|Participant Flow|Sugar Pill|Placebo Control
810030|NCT01361633|P1|Participant Flow|Medication|250 mg d-cycloserine
810031|NCT01361633|O2|Outcome|Sugar Pill|Placebo control
810032|NCT01361633|O1|Outcome|Medication|250mg d-cycloserine
810033|NCT01361633|E2|Reported Event|Sugar Pill|Placebo Control
810034|NCT01361633|E1|Reported Event|Medication|250 mg d-cycloserine
810035|NCT01361620|B1|Baseline|Aspirin|All subjects took 7-10 days of 81 mg aspirin
810036|NCT01361620|P1|Participant Flow|Aspirin|All subjects took 7-10 days of 81 mg aspirin
810037|NCT01361620|O1|Outcome|Aspirin|All subjects took 7-10 days of 81 mg aspirin
810038|NCT01361620|E1|Reported Event|Aspirin|All subjects took 7-10 days of 81 mg aspirin
810039|NCT01361594|B3|Baseline|Total|Total of all reporting groups
810040|NCT01361594|B2|Baseline|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
810041|NCT01361594|B1|Baseline|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
810042|NCT01361594|P2|Participant Flow|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
810043|NCT01361594|P1|Participant Flow|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
810044|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
810045|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
810046|NCT01361594|O2|Outcome|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
810047|NCT01361594|O1|Outcome|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
810048|NCT01361594|E2|Reported Event|Conventional Insulin Treatment|"Conventional insulin treatment (BG target: 141-180 mg/dl)~Regular Insulin (conventional treatment): Titration of the IV insulin rate for glucose goal 141-180 mg/dl"
810049|NCT01361594|E1|Reported Event|Intensive Insulin Treatment|"Intensive insulin treatment (BG target: 100-140 mg/dL)~Regular insulin (intensive treatment): Titration of the IV insulin rate for glucose goal 100-140 mg/dL"
810050|NCT01361568|B7|Baseline|Total|Total of all reporting groups
810051|NCT01361568|B6|Baseline|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
810052|NCT01361568|B5|Baseline|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
810053|NCT01361568|B4|Baseline|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
810054|NCT01361568|B3|Baseline|CR845-CR845|CR845 administered both preoperatively and postoperatively
810055|NCT01361568|B2|Baseline|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
810056|NCT01361568|B1|Baseline|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
810057|NCT01361568|P6|Participant Flow|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
810058|NCT01361568|P5|Participant Flow|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
810059|NCT01361568|P4|Participant Flow|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
810060|NCT01361568|P3|Participant Flow|CR845-CR845|CR845 administered both preoperatively and postoperatively
810061|NCT01361568|P2|Participant Flow|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
810062|NCT01361568|P1|Participant Flow|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
810063|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
810064|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
810065|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
810066|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only, either preoperatively and/or postoperatively
810067|NCT01361568|O2|Outcome|CR845|Patients administered CR845 either preoperatively and/or postoperatively
810068|NCT01361568|O1|Outcome|Placebo|Patients administered placebo only either preoperatively and/or postoperatively
810069|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
810070|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
810071|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
810072|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
810073|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
810074|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
810075|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
810076|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
810077|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
810078|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
810079|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
810080|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
810081|NCT01361568|O4|Outcome|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
810082|NCT01361568|O3|Outcome|CR845-CR845|CR845 administered both preoperatively and postoperatively
810083|NCT01361568|O2|Outcome|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
810084|NCT01361568|O1|Outcome|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
810085|NCT01361568|E6|Reported Event|Placebo-No Postoperative Treatment|Placebo administered preoperatively and no study drug administered postoperatively
810086|NCT01361568|E5|Reported Event|CR845-No Postoperative Treatment|CR845 administered preoperatively and no study drug administered postoperatively
810087|NCT01361568|E4|Reported Event|CR845-Placebo|CR845 administered preoperatively and placebo administered postoperatively
810088|NCT01361568|E3|Reported Event|CR845-CR845|CR845 administered both preoperatively and postoperatively
810089|NCT01361568|E2|Reported Event|Placebo-CR845|Placebo administered preoperatively and CR845 administered postoperatively
810090|NCT01361568|E1|Reported Event|Placebo-Placebo|Placebo administered both preoperatively and postoperatively
810091|NCT01361464|B1|Baseline|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
810092|NCT01361464|P1|Participant Flow|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
810093|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
810094|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
812309|NCT01352845|B2|Baseline|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
810095|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
810096|NCT01361464|O1|Outcome|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
810097|NCT01361464|E1|Reported Event|R115777 Therapy|Each participant will begin R115777 treatment with an orally dosed regimen of 300 mg twice a day (BID) for the first 21 consecutive days of a 28-day cycle.
810098|NCT01361308|B3|Baseline|Total|Total of all reporting groups
810099|NCT01361308|B2|Baseline|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810100|NCT01361308|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810101|NCT01361308|P2|Participant Flow|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810102|NCT01361308|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810103|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810104|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810105|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810106|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810107|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810108|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810109|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810110|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810111|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810112|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810113|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810114|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810115|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810116|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810117|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810118|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810119|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810120|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810121|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810122|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810123|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810124|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810125|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810126|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810127|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810128|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810129|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810130|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810131|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810132|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810133|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810134|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810135|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810136|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810137|NCT01361308|O2|Outcome|Placebo Capsules|Subjects were randomized to receive placebo capsules (sugar pill) orally administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810138|NCT01361308|O1|Outcome|Brisdelle (Paroxetine Mesylate) 7.5 mg Capsules|Subjects were randomized to receive Brisdelle (paroxetine mesylate) 7.5 mg Capsules administered orally once daily at bedtime beginning on Day 1 and continuing up to Day 84
810139|NCT01361308|E2|Reported Event|Placebo Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810140|NCT01361308|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|Subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
810141|NCT01361178|B3|Baseline|Total|Total of all reporting groups
810142|NCT01361178|B2|Baseline|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
810143|NCT01361178|B1|Baseline|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
810144|NCT01361178|P2|Participant Flow|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
810145|NCT01361178|P1|Participant Flow|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
810146|NCT01361178|O2|Outcome|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
810147|NCT01361178|O1|Outcome|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
810148|NCT01361178|E2|Reported Event|Transplant Patients Who Receive SQ IVIG|"Patients participating in the observational arm of the study who are randomized to receive a dosage of SQ IVIG due to low IgG level.~SQ IVIG: Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week"
810149|NCT01361178|E1|Reported Event|Transplant Patients Who do Not Receive SQ IVIG|Patients participating in the observational arm of the study who do not need to receive IgG replacement.
810150|NCT01361126|B3|Baseline|Total|Total of all reporting groups
810151|NCT01361126|B2|Baseline|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
810152|NCT01361126|B1|Baseline|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
810153|NCT01361126|P2|Participant Flow|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered 1 or more IV infusions of rIX-FP at a dose of at least 25 IU/kg to treat minor, moderate or major bleeding episodes. The dose of rIX-FP was calculated by the investigator.
810357|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810154|NCT01361126|P1|Participant Flow|Prophylactic|For the PK evaluation, subjects received a single intravenous (IV) infusion of Recombinant Coagulation Factor IX Albumin Fusion Protein (rIX-FP) at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
810155|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg. After completion of the PK evaluation period, subjects entered the treatment period and were administered a single IV infusion of rIX-FP once a week at a dose of 15 to 35 IU/kg, or at a dose determined by the investigator. The dose was adjusted up to 75 IU/kg to maintain the trough FIX activity level > 1% between infusions.
810156|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810157|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810158|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810159|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810160|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810161|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810162|NCT01361126|O2|Outcome|On-demand|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810163|NCT01361126|O1|Outcome|Prophylactic|For the PK evaluation, subjects received a single IV infusion of rIX-FP at a dose of 25 IU/kg.
810164|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
810165|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
810166|NCT01361126|O1|Outcome|All Subjects|Subjects received rIX-FP as prophylactic treatment once a week or on-demand to treat bleeding episodes administered by IV infusion for 20 weeks.
810167|NCT01361126|E1|Reported Event|All Subjects|Subjects received rIX-FP administered by IV infusion as prophylactic treatment once a week or on demand to treat bleeding episodes for 20 weeks.
810168|NCT01361113|B1|Baseline|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
810169|NCT01361113|P1|Participant Flow|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
810170|NCT01361113|O1|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
810171|NCT01361113|O1|Outcome|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
810172|NCT01361113|E1|Reported Event|Single Arm Neoadjuvant Pazopanib|"Pazopanib 800 mg PO once daily for 8 weeks~Pazopanib: 800 mg orally once daily for 8 weeks, prior to nephrectomy"
810173|NCT01361048|B4|Baseline|Total|Total of all reporting groups
810174|NCT01361048|B3|Baseline|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
810175|NCT01361048|B2|Baseline|Neo Penotran Forte Twice a Day|neo penotran forte vaginal suppository twice a day for 7 days
810176|NCT01361048|B1|Baseline|Oral Metronidazole|control arm
810177|NCT01361048|P3|Participant Flow|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
810178|NCT01361048|P2|Participant Flow|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
810179|NCT01361048|P1|Participant Flow|Oral Metronidazole|control arm
810180|NCT01361048|O3|Outcome|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
810181|NCT01361048|O2|Outcome|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
810182|NCT01361048|O1|Outcome|Oral Metronidazole 2 gm Stat Dose|control arm
810183|NCT01361048|E3|Reported Event|Neo Penotran Forte Once a Day|neo penotran forte vaginal suppository once a day for 7 days
810184|NCT01361048|E2|Reported Event|Neo Penotran Forte|neo penotran forte vaginal suppository twice a day for 7 days
810185|NCT01361048|E1|Reported Event|Oral Metronidazole|control arm
810186|NCT01361009|B1|Baseline|Pramipexole Goup|
810187|NCT01361009|P1|Participant Flow|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
810188|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
810189|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
810190|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
810191|NCT01361009|O1|Outcome|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
810192|NCT01361009|E1|Reported Event|Pramipexole Goup|An open-label, non-controlled, non-interventional, observational post marketing surveillance to observe the safety and efficacy of pramipexole in real world.
810193|NCT01360996|B4|Baseline|Total|Total of all reporting groups
810194|NCT01360996|B3|Baseline|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810397|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
810195|NCT01360996|B2|Baseline|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810196|NCT01360996|B1|Baseline|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810197|NCT01360996|P3|Participant Flow|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810198|NCT01360996|P2|Participant Flow|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810199|NCT01360996|P1|Participant Flow|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810200|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
810201|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
810202|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
810203|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
810204|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
810205|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
810206|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
810207|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
810208|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
810209|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
810210|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
810211|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
810212|NCT01360996|O2|Outcome|Obese|"Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 30-34.9 kg/m2 (obese grade 10"
810213|NCT01360996|O1|Outcome|Non-Obese|"There was no significant difference on any variables between normal and overweight at baseline so groups were combined into non-obese~Folate-boosted 3 mg DRSP/20 ug EE-24/4 oral contraceptive~BMI 18-29.9 kg/m2"
810214|NCT01360996|E3|Reported Event|3 mg DRSP/20 μg EE- Grade 1 Obese|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 30-34.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810215|NCT01360996|E2|Reported Event|3 mg DRSP/20 μg EE- Overweight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~BMI 25-29.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810216|NCT01360996|E1|Reported Event|3 mg DRSP/20 μg EE--normal Weight|"Folate-boosted 3 mg DRSP/20 μg EE-24/4 oral contraceptive~Normal weight -BMI 18-24.9 kg/ m2~3 mg DRSP/20 μg EE: 1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only"
810217|NCT01360840|B4|Baseline|Total|Total of all reporting groups
810218|NCT01360840|B3|Baseline|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810219|NCT01360840|B2|Baseline|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810285|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810220|NCT01360840|B1|Baseline|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810221|NCT01360840|P3|Participant Flow|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810222|NCT01360840|P2|Participant Flow|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810223|NCT01360840|P1|Participant Flow|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the standard of care (SoC) consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810224|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810225|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810226|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810227|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810228|NCT01360840|O2|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810229|NCT01360840|O1|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810230|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810231|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810358|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810359|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810232|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810233|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810234|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810235|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810236|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810237|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810238|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810239|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810240|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810241|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810242|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810243|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810286|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
812663|NCT01351064|B2|Baseline|CHICA ADHD Control|This arm received CHICA without the ADHD module
810244|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810245|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810246|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810247|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810248|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810249|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810250|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810251|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810252|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810253|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810254|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810255|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810287|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
812955|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
810256|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810257|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810258|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810259|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810260|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810261|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810262|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810263|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810264|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810265|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810266|NCT01360840|O3|Outcome|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810267|NCT01360840|O2|Outcome|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810288|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
812956|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
810268|NCT01360840|O1|Outcome|Placebo + SoC|Subjects were administered with placebo 0.9% sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810269|NCT01360840|E3|Reported Event|EMD 525797 1500 mg + SoC|Subjects were administered with EMD 525797 at a dose of 1500 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810270|NCT01360840|E2|Reported Event|EMD 525797 750 mg + SoC|Subjects were administered with EMD 525797 at a dose of 750 milligram (mg) (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810271|NCT01360840|E1|Reported Event|Placebo + SoC|Subjects were administered with placebo 0.9 percent (%) sodium chloride as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons. All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists). In order to avoid any confounding effects, bisphosphonate treatment was initiated 2 days before start of treatment with EMD 525797.
810272|NCT01360554|B3|Baseline|Total|Total of all reporting groups
810273|NCT01360554|B2|Baseline|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810274|NCT01360554|B1|Baseline|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810275|NCT01360554|P2|Participant Flow|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810276|NCT01360554|P1|Participant Flow|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810277|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810278|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810279|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810280|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810281|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810282|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810283|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810284|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810356|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810289|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810290|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810291|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810292|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810293|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810294|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810295|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810296|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810297|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810298|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810299|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810300|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810301|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810302|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810303|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810304|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810305|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810306|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810307|NCT01360554|O2|Outcome|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810308|NCT01360554|O1|Outcome|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810309|NCT01360554|E2|Reported Event|Arm B (Blinded Erlotinib and Blinded Dacomitinib Placebo)|Participants randomized to Arm B received erlotinib 150 mg orally once daily and dacomitinib 45 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810310|NCT01360554|E1|Reported Event|Arm A (Blinded Dacomitinib and Blinded Erlotinib Placebo)|Participants randomized to Arm A received dacomitinib 45 mg orally once daily and erlotinib 150 mg placebo orally once daily. Participants began treatment within 3 days after randomization and continued treatment without breaks until they experienced unacceptable toxicity, tumor progression, or death.
810311|NCT01360021|B4|Baseline|Total|Total of all reporting groups
810312|NCT01360021|B3|Baseline|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810313|NCT01360021|B2|Baseline|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810314|NCT01360021|B1|Baseline|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810315|NCT01360021|P3|Participant Flow|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810316|NCT01360021|P2|Participant Flow|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810317|NCT01360021|P1|Participant Flow|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810318|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810319|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810320|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810321|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810322|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810323|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810324|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810325|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810326|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810327|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810328|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810329|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810330|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810331|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810332|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810333|NCT01360021|O3|Outcome|Budesonide|Budesonide AC pMDI 2x160 μg twice daily
810334|NCT01360021|O2|Outcome|Symbicort pMDI|Symbicort AC pDMI 2x160/4.5 μg twice daily
810335|NCT01360021|O1|Outcome|Symbicort BA MDI|Symbicort BA MDI 2x160/4.5 μg twice daily
810336|NCT01360021|E3|Reported Event|Symbicort pMDI|
810337|NCT01360021|E2|Reported Event|Symbicort BA MDI|
810338|NCT01360021|E1|Reported Event|Budesonide|
810339|NCT01359943|B4|Baseline|Total|Total of all reporting groups
810340|NCT01359943|B3|Baseline|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810341|NCT01359943|B2|Baseline|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810342|NCT01359943|B1|Baseline|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810343|NCT01359943|P3|Participant Flow|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810344|NCT01359943|P2|Participant Flow|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810345|NCT01359943|P1|Participant Flow|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810346|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810347|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810348|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810349|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810350|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810351|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810352|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810353|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810354|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810355|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810360|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810361|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810362|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810363|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810364|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810365|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810366|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810367|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810368|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810369|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810370|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810371|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810372|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810373|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810374|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810375|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810376|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810377|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810378|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810379|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810380|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810381|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810382|NCT01359943|O3|Outcome|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810383|NCT01359943|O2|Outcome|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810384|NCT01359943|O1|Outcome|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810385|NCT01359943|E5|Reported Event|AIN457 Pooled Treatment Groups - Follow-up Period|Follow-up period: week 52 through week 60 - AIN457 150 mg sc open label
810386|NCT01359943|E4|Reported Event|AIN457 Pooled Treatment Groups - Open Label Period|Week 16 through week 52: AIN457 150 mg s.c. open label
810387|NCT01359943|E3|Reported Event|Placebo|placebo at Weeks 0, 1, 2, 3, 4, 8 & 12, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 16
810388|NCT01359943|E2|Reported Event|Secukinumab 150 mg s.c. Loading|secukinumab 150mg s.c. loading at Weeks 0, 1, 2, 3 and 4, and placebo i.v. at weeks 0, 2 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810389|NCT01359943|E1|Reported Event|Secukinumab 10 mg/kg i.v. Loading|secukinumab 10mg/kg i.v. loading at Weeks 0, 2 and 4, and placebo s.c. at weeks 0, 1, 2, 3 and 4, followed by secukinumab 150mg s.c. every 4 weeks starting at Week 8
810390|NCT01359904|B3|Baseline|Total|Total of all reporting groups
810391|NCT01359904|B2|Baseline|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
810392|NCT01359904|B1|Baseline|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
810393|NCT01359904|P2|Participant Flow|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
810394|NCT01359904|P1|Participant Flow|High Dialysate Bath|additive is put in the dialysate to increase the concentration of glucose to 10mmol/l
810395|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
810396|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
810398|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
810399|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
810400|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
810401|NCT01359904|O2|Outcome|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
810402|NCT01359904|O1|Outcome|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
810403|NCT01359904|E2|Reported Event|Standard Dialysate Glucose Concentration|Standard 5.5 mmol/L dialysate glucose concentration.
810404|NCT01359904|E1|Reported Event|High Dialysate Bath|"additive is put in the dialysate to increase the concentration of glucose to 10mmol/l~High Dialysate bath: The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution."
810405|NCT01359748|B5|Baseline|Total|Total of all reporting groups
810406|NCT01359748|B4|Baseline|Wrist Size >=17.75|Subjects, males or females, with wrist size specified.
810407|NCT01359748|B3|Baseline|Wrist Size >=16.5 Cm|Subjects, males or females, with wrist size specified.
810408|NCT01359748|B2|Baseline|Wrist Size<=16.40 Cm|Subjects, males or females, with wrist size specified.
810409|NCT01359748|B1|Baseline|Wrist Size <=14.25Cm|Subjects, males or females, with wrist size specified.
810410|NCT01359748|P4|Participant Flow|Subjects With Wrist Size >=17.75Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
810411|NCT01359748|P3|Participant Flow|Subjects With Wrist Size >=16.50Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
810412|NCT01359748|P2|Participant Flow|Subjects With Wrist Size <=14.25Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
810413|NCT01359748|P1|Participant Flow|Subjects With Wrist Size >=14.26Cm|"Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009. The reference Aneroid sphygmomanometer RIESTER MINIMUS II has an adjustable cuff from 24 cm to 32 cm on arm circumference.~The KEITO's cuff is not adjustable, the wrist circumference admissible is 12 to 20 cm."
810414|NCT01359748|O1|Outcome|Subjects|Patients who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
810415|NCT01359748|O1|Outcome|Subjects|Subjects who meet with chapter 5 of Standard ANSI/AAMI/ISO 81060-2:2009
810416|NCT01359748|E4|Reported Event|Wrist Size >=17.75 Cm|Subjects with wrist size equal or higher than 17.75 Cm
810417|NCT01359748|E3|Reported Event|Wrist Size >=16.5 Cm|Subjects with wrist size equal or higher than 16.5 Cm
810418|NCT01359748|E2|Reported Event|Wrist Size <=16.4Cm|Subjects with wrist size equal or less than 16.40 Cm
810419|NCT01359748|E1|Reported Event|Wrist Size <=14.25 Cm|Subjects with wrist size equal or less than 14.25 Cm
810420|NCT01359644|B11|Baseline|Total|Total of all reporting groups
810421|NCT01359644|B10|Baseline|Treatment J: Sofosbuvir +Daclatasvir +Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavarin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg) and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
810422|NCT01359644|B9|Baseline|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810423|NCT01359644|B8|Baseline|Treatment H: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
810424|NCT01359644|B7|Baseline|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype1 a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks..
810425|NCT01359644|B6|Baseline|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
810426|NCT01359644|B5|Baseline|Treatment E: Sofosbuvir +Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
810427|NCT01359644|B4|Baseline|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype-2 or -3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks..
810428|NCT01359644|B3|Baseline|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810429|NCT01359644|B2|Baseline|Treatment: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
810430|NCT01359644|B1|Baseline|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotype 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
810431|NCT01359644|P10|Participant Flow|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
810432|NCT01359644|P9|Participant Flow|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810433|NCT01359644|P8|Participant Flow|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
810434|NCT01359644|P7|Participant Flow|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
810435|NCT01359644|P6|Participant Flow|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
810436|NCT01359644|P5|Participant Flow|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
810437|NCT01359644|P4|Participant Flow|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810438|NCT01359644|P3|Participant Flow|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810439|NCT01359644|P2|Participant Flow|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
810440|NCT01359644|P1|Participant Flow|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
810441|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
810442|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
810443|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
810444|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
810445|NCT01359644|O4|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
810446|NCT01359644|O3|Outcome|Daclatasvir + Sofosbuvir Without Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 12 weeks.
810447|NCT01359644|O2|Outcome|Daclatasvir + Sofosbuvir With Ribivirin (24 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 24 weeks.
810448|NCT01359644|O1|Outcome|Daclatasvir + Sofosbuvir + Ribivirin (12 Weeks)|Participants received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
810449|NCT01359644|O10|Outcome|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets at AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
810450|NCT01359644|O9|Outcome|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure were administered with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
810451|NCT01359644|O8|Outcome|Treatment H: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received with sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets) PM for participants weighing ≥75 kg) for 12 weeks.
810452|NCT01359644|O7|Outcome|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
810453|NCT01359644|O6|Outcome|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks.
812957|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
810454|NCT01359644|O5|Outcome|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
810455|NCT01359644|O4|Outcome|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received with sofosbuvir, 400 mg, once daily, and daclatasvir, 60 mg, once daily for 24 weeks.
810456|NCT01359644|O3|Outcome|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810457|NCT01359644|O2|Outcome|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
810458|NCT01359644|O1|Outcome|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus genotypes 1a or 1b received sofosbuvir, 400 mg, once daily) for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
810459|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
810460|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
810461|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
810462|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
810463|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
810464|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
810465|NCT01359644|O3|Outcome|Telaprevir/Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
810466|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
810467|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation or ribavirin or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir 400 mg tablets + daclatasvir 60 mg tablets ± ribavirin (a total daily dose of 1000 mg/1200mg) tablets once daily for 12 or 24 weeks.
810468|NCT01359644|O3|Outcome|Telaprevir or Boceprevir Failures With Genotype 1|Participants with genotype 1a or 1b who experienced telaprevir or boceprevir treatment failure received sofosbuvir, 400 mg + daclatasvir, 60 mg, tablets ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 24 weeks.
810469|NCT01359644|O2|Outcome|Treatment-naive Participants With Genotype 2 or 3|Participants with genotype 2 or 3 and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct-acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg ± ribavirin (a total daily dose of 1000 mg/1200 mg) once daily for 12 or 24 weeks.
810470|NCT01359644|O1|Outcome|Treatment-naive Participants With Genotype 1|Participants with genotype 1a or 1b and no previous exposure to an interferon formulation, ribavirin, or other hepatitis C virus-specific direct acting antiviral received sofosbuvir, 400 mg + daclatasvir, 60 mg, ± ribavirin (a total daily dose of 1000 mg/1200 mg) tablets once daily for 12 or 24 weeks.
810471|NCT01359644|E10|Reported Event|Treatment J: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 24 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥75 kg) for 24 weeks.
810472|NCT01359644|E9|Reported Event|Treatment I: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b who experienced telaprevir/boceprevir treatment failure received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810473|NCT01359644|E8|Reported Event|Treatment H : Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily, daclatasvir, 60 mg, once daily for 12 weeks and ribavirin (in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM for participants weighing ≥ 75 kg) for 12 weeks.
810474|NCT01359644|E7|Reported Event|Treatment G: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 12 weeks.
810475|NCT01359644|E6|Reported Event|Treatment F: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavarin in total daily dose of 800 mg (2 200-mg tablets AM and 2 200-mg tablets PM) for 24 weeks
810476|NCT01359644|E5|Reported Event|Treatment E: Sofosbuvir + Daclatasvir + Ribavirin|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily; daclatasvir, 60 mg, once daily for 24 weeks; and ribavirin in a total daily dose of 1000 mg (2 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing <75 kg and a total daily dose of 1200 mg (3 200-mg tablets AM and 3 200-mg tablets PM) for participants weighing ≥75 kg for 24 weeks.
810477|NCT01359644|E4|Reported Event|Treatment D: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810478|NCT01359644|E3|Reported Event|Treatment C: Sofosbuvir + Daclatasvir|Participants with genotype 1a or 1b received sofosbuvir, 400 mg, once daily and daclatasvir, 60 mg, once daily for 24 weeks.
810479|NCT01359644|E2|Reported Event|Treatment B: Sofosbuvir + Daclatasvir|Participants with genotype 2 or 3 received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks
810480|NCT01359644|E1|Reported Event|Treatment A: Sofosbuvir + Daclatasvir|Participants with hepatitis C virus (HCV) genotypes 1a or 1b received sofosbuvir, 400 mg, once daily for 7 days and then added daclatasvir, 60 mg, once daily for 24 weeks.
810481|NCT01359449|B3|Baseline|Total|Total of all reporting groups
810482|NCT01359449|B2|Baseline|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810483|NCT01359449|B1|Baseline|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810484|NCT01359449|P2|Participant Flow|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810485|NCT01359449|P1|Participant Flow|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810486|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810487|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810488|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810489|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810490|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810491|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810492|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810493|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810494|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810495|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810496|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810497|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810498|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810499|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810500|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810501|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810502|NCT01359449|O2|Outcome|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810503|NCT01359449|O1|Outcome|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810504|NCT01359449|E2|Reported Event|Menjugate® Vaccine Group|Participants received Menjugate® vaccine given concomitantly at 12 months of age with routine vaccines administered as per provincial schedule.
810505|NCT01359449|E1|Reported Event|Menactra® Vaccine Group|Participants received one dose of Menactra® vaccine at 12 months of age and a second dose on Menactra® vaccine at 18 months of age concomitantly with routine vaccines administered as per provincial schedule (including the 4th dose of Pediacel® at 18 months of age)
810506|NCT01359410|B3|Baseline|Total|Total of all reporting groups
810507|NCT01359410|B2|Baseline|Stapled Transection Without Mesh Reinforcement|
810508|NCT01359410|B1|Baseline|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810509|NCT01359410|P2|Participant Flow|Stapled Transection Without Mesh Reinforcement|
810510|NCT01359410|P1|Participant Flow|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810511|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
810512|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810513|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
810514|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810515|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
810516|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810517|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
810518|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810519|NCT01359410|O2|Outcome|Stapled Transection Without Mesh Reinforcement|
810520|NCT01359410|O1|Outcome|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810521|NCT01359410|E2|Reported Event|Stapled Transection Without Mesh Reinforcement|
810522|NCT01359410|E1|Reported Event|Stapled Transection With Mesh Reinforcement|Mesh reinforced staple line (SEAMGUARD® or PERI-STRIPS DRY®)
810523|NCT01359371|B1|Baseline|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
810524|NCT01359371|P1|Participant Flow|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
810525|NCT01359371|O2|Outcome|Number of Times Reached for Peer Telephone Counseling:3-4times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 3-4 times for peer telephone counseling.
810526|NCT01359371|O1|Outcome|Number of Times Reached for Peer Telephone Counseling:0-2times|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital. This group was reached 0-2 times for peer telephone counseling.
810527|NCT01359371|E1|Reported Event|Volunteer Telephone Cessation Counseling|The cohort is discharged veteran smokers who received the standard-of-care Tobacco Tactics intervention while in the hospital.
810528|NCT01359254|B3|Baseline|Total|Total of all reporting groups
810529|NCT01359254|B2|Baseline|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
810530|NCT01359254|B1|Baseline|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
810531|NCT01359254|P2|Participant Flow|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
810532|NCT01359254|P1|Participant Flow|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
810533|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
810534|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
810535|NCT01359254|O2|Outcome|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
810536|NCT01359254|O1|Outcome|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
810558|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810537|NCT01359254|E2|Reported Event|Fludarabine, Busulfan, ATG, and TBI|"Arm II contains fludarabine, busulfan, antithymocyte globulin (ATG), and total body irradiation (TBI).~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days.~Busulfan: Busulfan is given daily for 4 days.~Total Body Irradiation (TBI): TBI is given twice on the last day."
810538|NCT01359254|E1|Reported Event|Fludarabine, Melphalan, and ATG|"Arm I contains fludarabine, melphalan, and antithymocyte globulin (ATG)~Melphalan: Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.~Fludarabine: Fludarabine is given through the vein daily for 5 days.~Antithymocyte Globulin (ATG): ATG is given every other day for 4 days."
810539|NCT01359150|B3|Baseline|Total|Total of all reporting groups
810540|NCT01359150|B2|Baseline|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810541|NCT01359150|B1|Baseline|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810542|NCT01359150|P2|Participant Flow|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810543|NCT01359150|P1|Participant Flow|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810544|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810545|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810546|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810547|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810548|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810549|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810550|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810551|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810552|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810553|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810554|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810555|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810556|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810557|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810691|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810559|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810560|NCT01359150|O2|Outcome|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810561|NCT01359150|O1|Outcome|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810562|NCT01359150|E2|Reported Event|Placebo + Influenza and Pneumococcal Vaccine|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810563|NCT01359150|E1|Reported Event|CP-690,550 + Influenza and Pneumococcal Vaccine|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 64, with or without background Methotrexate therapy as per local standard prescribing practice. Participants were vaccinated on Day 29 with influenza and pneumococcal vaccine based on standard practice.
810564|NCT01359111|B1|Baseline|Intradermal Adapter|Saline injection with intradermal adapter
810565|NCT01359111|P1|Participant Flow|Intradermal Adapter|Saline injection with intradermal adapter
810566|NCT01359111|O2|Outcome|Bevel Down|Saline injection with intradermal adapter used with needle bevel oriented down relative to the surface of the skin
810567|NCT01359111|O1|Outcome|Bevel Up|Saline injection with intradermal adapter used with needle bevel oriented up relative to the surface of the skin
810568|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
810569|NCT01359111|O1|Outcome|Intradermal Adapter|Saline injection with intradermal adapter
810570|NCT01359111|E1|Reported Event|Intradermal Adapter|Saline injection with intradermal adapter
810571|NCT01358864|B9|Baseline|Total|Total of all reporting groups
810572|NCT01358864|B8|Baseline|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810573|NCT01358864|B7|Baseline|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810574|NCT01358864|B6|Baseline|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810575|NCT01358864|B5|Baseline|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810576|NCT01358864|B4|Baseline|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810577|NCT01358864|B3|Baseline|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810578|NCT01358864|B2|Baseline|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810579|NCT01358864|B1|Baseline|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810580|NCT01358864|P8|Participant Flow|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810581|NCT01358864|P7|Participant Flow|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810582|NCT01358864|P6|Participant Flow|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810583|NCT01358864|P5|Participant Flow|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810584|NCT01358864|P4|Participant Flow|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810585|NCT01358864|P3|Participant Flow|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810586|NCT01358864|P2|Participant Flow|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir (BI 201335) 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810587|NCT01358864|P1|Participant Flow|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810588|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810589|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810590|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810591|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810592|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810593|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810594|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810595|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810596|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810597|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810598|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810599|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810600|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810601|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810602|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810603|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810604|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
812958|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
810605|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810606|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810607|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810608|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810609|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810610|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810611|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810612|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810613|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810614|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810615|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810616|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810617|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810618|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810619|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810620|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810621|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810622|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810623|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810624|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810692|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810625|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810626|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810627|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810628|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810629|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810630|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810631|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810632|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810633|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810634|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810635|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810636|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810637|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810638|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810639|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810640|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810641|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810642|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810643|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810644|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810945|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810645|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810646|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810647|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810648|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810649|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810650|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810651|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810652|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810653|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810654|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
810655|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
810656|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810657|NCT01358864|O8|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810658|NCT01358864|O7|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810659|NCT01358864|O6|Outcome|Partial:Faldaprevir 24 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810660|NCT01358864|O5|Outcome|Partial:Faldaprevir 12 Weeks|Patients who had had a prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810661|NCT01358864|O4|Outcome|Partial:Placebo|Patients who had had a prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810662|NCT01358864|O3|Outcome|Relapser:Faldaprevir 24 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810663|NCT01358864|O2|Outcome|Relapser:Faldaprevir 12 Weeks|Patients who had had a prior relapse, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. At week 24, if the patients did not achieve early treatment success (ETS) the patients received an additional 24 weeks of PegIFN/RBV alone.
810664|NCT01358864|O1|Outcome|Relapser:Placebo|Patients who had had a prior relapse, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV (Pegylated interferon alpha-2a/Ribavirin) administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810665|NCT01358864|O5|Outcome|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810666|NCT01358864|O4|Outcome|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810667|NCT01358864|O3|Outcome|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
810668|NCT01358864|O2|Outcome|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
810669|NCT01358864|O1|Outcome|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810670|NCT01358864|E5|Reported Event|Null:Faldaprevir 24 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810671|NCT01358864|E4|Reported Event|Null:Faldaprevir 12 Weeks|Patients who had had a prior null response received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks.
810672|NCT01358864|E3|Reported Event|Relapser & Partial: Faldaprevir 24 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 24 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
810673|NCT01358864|E2|Reported Event|Relapser & Partial: Faldaprevir 12 Weeks|Patients who had had a prior relapse or prior partial response, received Faldaprevir 240mg once daily, in the form of 2 soft gelatin capsules administered orally, combined with PegIFN/RBV, administered by injection, for 12 weeks, followed by placebo once daily combined with PegIFN/RBV for 12 weeks. Followed by PegIFN/RBV alone for 24 weeks (for the partial relapsers the last 24 weeks was only if the patient did not achieve early treatment success (ETS)).
810674|NCT01358864|E1|Reported Event|Relapser & Partial: Placebo|Patients who had had a prior relapse or prior partial response, received 2 soft gelatin capsules identical to those containing Faldaprevir once daily (orally) and PegIFN/RBV administered by injection, for 24 weeks, followed by PegIFN/RBV for 24 weeks.
810675|NCT01358825|B3|Baseline|Total|Total of all reporting groups
810676|NCT01358825|B2|Baseline|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810677|NCT01358825|B1|Baseline|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810678|NCT01358825|P2|Participant Flow|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810679|NCT01358825|P1|Participant Flow|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810680|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810681|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810682|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810683|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810684|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810685|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810686|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810687|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810688|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810689|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810690|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810693|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810694|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810695|NCT01358825|O2|Outcome|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810696|NCT01358825|O1|Outcome|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810697|NCT01358825|E2|Reported Event|Infanrix-IPV/Hib Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix-IPV/Hib™ (administered intramuscularly) in study NCT00307034.
810698|NCT01358825|E1|Reported Event|Infanrix Hexa Group|Subjects aged 5 years previously vaccinated at 3, 5 and 11 months of age with 3 doses of Infanrix hexa™ (administered intramuscularly) in study NCT00307034.
810699|NCT01358760|B4|Baseline|Total|Total of all reporting groups
810700|NCT01358760|B3|Baseline|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810701|NCT01358760|B2|Baseline|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810702|NCT01358760|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810703|NCT01358760|P3|Participant Flow|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810704|NCT01358760|P2|Participant Flow|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810705|NCT01358760|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810706|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810707|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810708|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810709|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810710|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810711|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810712|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810713|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810714|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810715|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810716|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810717|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810718|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810719|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810720|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810721|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810722|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810723|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810724|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810725|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810726|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810727|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810903|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810728|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810729|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810730|NCT01358760|O3|Outcome|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810731|NCT01358760|O2|Outcome|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810732|NCT01358760|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810733|NCT01358760|E3|Reported Event|0.50% DHEA|DHEA (prasterone): Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810734|NCT01358760|E2|Reported Event|0.25% DHEA|DHEA (prasterone): Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810735|NCT01358760|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository; daily dosing with one suppository for 2 weeks followed by twice weekly dosing for 10 weeks.
810736|NCT01358734|B4|Baseline|Total|Total of all reporting groups
810737|NCT01358734|B3|Baseline|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
810738|NCT01358734|B2|Baseline|Azacitidine + Lenalidomide|Azacitidine 75 mg/m^2/ daily subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg daily PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
810739|NCT01358734|B1|Baseline|Lenalidomide|Lenalidomide 50 mg/day by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg daily PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily
810740|NCT01358734|P3|Participant Flow|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
810741|NCT01358734|P2|Participant Flow|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
810742|NCT01358734|P1|Participant Flow|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
810743|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
810744|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
810745|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
810746|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
810747|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
810748|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
810749|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
810750|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
810751|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
810752|NCT01358734|O3|Outcome|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
810753|NCT01358734|O2|Outcome|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
810754|NCT01358734|O1|Outcome|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
810755|NCT01358734|E3|Reported Event|Azacitidine|Azacitidine 75mg/m^2 administered SC on Days 1 through 7 followed by a 21-day rest period plus BSC
810756|NCT01358734|E2|Reported Event|Azacitidine Plus Lenalidomide|Azacitidine 75 mg/m^2/ QD administered subcutaneously (SC) on Days 1 through 7 and lenalidomide 50 mg QD PO on Days 8 through 28 followed by a 14-day rest period plus best supportive care (BSC)
810757|NCT01358734|E1|Reported Event|Lenalidomide|Lenalidomide 50 mg daily (QD) by mouth (PO) for 28 days for the first 2 cycles followed by 25 mg QD PO for 28 days for the next 2 cycles followed by continuous 28-day cycles of oral lenalidomide 10 mg daily plus best supportive care (BSC), including antibiotics and transfusions, at the investigator's discretion.
810758|NCT01358708|B3|Baseline|Total|Total of all reporting groups
810759|NCT01358708|B2|Baseline|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810760|NCT01358708|B1|Baseline|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810761|NCT01358708|P2|Participant Flow|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810762|NCT01358708|P1|Participant Flow|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810763|NCT01358708|O3|Outcome|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810764|NCT01358708|O2|Outcome|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810765|NCT01358708|O1|Outcome|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810766|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810767|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810768|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810769|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810770|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810771|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810772|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810773|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810774|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810775|NCT01358708|O2|Outcome|PLACEBO|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810776|NCT01358708|O1|Outcome|LACTEOL® 340 mg|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810777|NCT01358708|E3|Reported Event|LACTEOL® 340 mg Open-Label Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810778|NCT01358708|E2|Reported Event|PLACEBO Double-Blind Period|Matched LACTEOL® placebo was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810779|NCT01358708|E1|Reported Event|LACTEOL® 340 mg Double-Blind Period|LACTEOL® active medication was taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
810780|NCT01358578|B5|Baseline|Total|Total of all reporting groups
810781|NCT01358578|B4|Baseline|Etanercept|Etanercept
810782|NCT01358578|B3|Baseline|Placebo|Placebo
810783|NCT01358578|B2|Baseline|AIN457 300mg|AIN457 300mg
810784|NCT01358578|B1|Baseline|AIN457 150mg|AIN457 150mg
810785|NCT01358578|P6|Participant Flow|AIN457 300mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
810786|NCT01358578|P5|Participant Flow|AIN457 150mg From Placebo|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
810787|NCT01358578|P4|Participant Flow|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
810788|NCT01358578|P3|Participant Flow|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
810789|NCT01358578|P2|Participant Flow|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810790|NCT01358578|P1|Participant Flow|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810791|NCT01358578|O6|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab
810901|NCT01358175|P1|Participant Flow|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810792|NCT01358578|O5|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to treatment groups based on their PASI 75 response status at Week 12:
810793|NCT01358578|O4|Outcome|PLACEBO-300 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 300 in maintenance
810794|NCT01358578|O3|Outcome|PLACEBO-150 mg AIN457|Patients were on Placebo in induction phase and if they were PASI 75 non responders at week 12 were re randomized to AIN457 150 in maintenance
810795|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810796|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810797|NCT01358578|O3|Outcome|Etanercept|etanercept 50 mg twice per week until Week 12
810798|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810799|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810800|NCT01358578|O3|Outcome|Placebo|AIN457A exact match Placebo
810801|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810802|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810803|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
810804|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810805|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810806|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
810807|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810808|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810809|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
810810|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810811|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810812|NCT01358578|O3|Outcome|Etanercept|Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c. injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab.
810813|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810814|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810815|NCT01358578|O4|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
810902|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810816|NCT01358578|O3|Outcome|Etanercept|"Subcutaneous (s.c.) etanercept 50 mg twice per week until Week 12, followed by s.c. etanercept 50 mg every week from Week 12 through Week 51. To maintain the blind, patients also received 2 placebo secukinumab s.c.~injections once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48, except for Weeks 13, 14, and 15 where patients received an additional weekly dose (comprised of 2 s.c. injections per dose) of placebo secukinumab."
810817|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810818|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810819|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
810820|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810821|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810822|NCT01358578|O3|Outcome|Placebo|s.c. placebo etanercept twice per week until Week 12 and s.c. placebo secukinumab (2 injections per dose) once per week for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks (at Weeks 4 and 8). Prior to receiving the Week 12 dose, all patients in the placebo group were assigned to the following treatment groups based on their PASI 75 response status at Week 12:
810823|NCT01358578|O2|Outcome|AIN457 300mg|s.c. secukinumab 300 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810824|NCT01358578|O1|Outcome|AIN457 150mg|s.c. secukinumab 150 mg injection plus a placebo secukinumab injection once weekly for 4 weeks (at randomization, Weeks 1, 2, and 3), followed by dosing every 4 weeks, starting at Week 4, and until Week 48
810825|NCT01358578|E14|Reported Event|FOLLOW UP-Etanercept|FOLLOW UP-Etanercept
810826|NCT01358578|E13|Reported Event|FOLLOW UP-Placebo|FOLLOW UP-Placebo
810827|NCT01358578|E12|Reported Event|FOLLOW UP-Any AIN457 300mg|FOLLOW UP-Any AIN457 300mg
810828|NCT01358578|E11|Reported Event|FOLLOW UP-Any AIN457 150mg|FOLLOW UP-Any AIN457 150mg
810829|NCT01358578|E10|Reported Event|ENTIRE-Etanercept|ENTIRE-Etanercept
810830|NCT01358578|E9|Reported Event|ENTIRE-Placebo|ENTIRE-Placebo
810831|NCT01358578|E8|Reported Event|ENTIRE-Any AIN457 300mg|ENTIRE-Any AIN457 300mg
810832|NCT01358578|E7|Reported Event|ENTIRE-Any AIN457 150mg|ENTIRE-Any AIN457 150mg
810833|NCT01358578|E6|Reported Event|ENTIRE-AIN457 300mg|ENTIRE-AIN457 300mg
810834|NCT01358578|E5|Reported Event|ENTIRE-AIN457 150mg|ENTIRE-AIN457 150mg
810835|NCT01358578|E4|Reported Event|INDUCTION-Etanercept|INDUCTION-Etanercept
810836|NCT01358578|E3|Reported Event|INDUCTION-Placebo|INDUCTION-Placebo
810837|NCT01358578|E2|Reported Event|INDUCTION-AIN457 300mg|INDUCTION-AIN457 300mg
810838|NCT01358578|E1|Reported Event|INDUCTION-AIN457 150mg|INDUCTION-AIN457 150mg
810839|NCT01358526|B3|Baseline|Total|Total of all reporting groups
810840|NCT01358526|B2|Baseline|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810841|NCT01358526|B1|Baseline|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810842|NCT01358526|P3|Participant Flow|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810843|NCT01358526|P2|Participant Flow|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810844|NCT01358526|P1|Participant Flow|Open-label Titration OXN|The open-label titration was designed to identify a stable, effective, and tolerable dose of OXN for each subject.
810845|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810846|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810847|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810848|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810849|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810850|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810851|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810852|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810853|NCT01358526|O2|Outcome|Placebo Group|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810854|NCT01358526|O1|Outcome|OXN Group|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810855|NCT01358526|E3|Reported Event|Double-blind OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810856|NCT01358526|E2|Reported Event|Double-blind Placebo|"Placebo tablets to match OXN~Placebo: Placebo tablets to match OXN taken orally every 12 hours"
810857|NCT01358526|E1|Reported Event|Open-label Titration OXN|"Oxycodone/Naloxone Controlled-release Tablets (OXN)~Oxycodone/Naloxone Controlled-release: Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours"
810858|NCT01358357|B3|Baseline|Total|Total of all reporting groups
810859|NCT01358357|B2|Baseline|Placebo|Placebo: 20-80 mg flexible dose
810860|NCT01358357|B1|Baseline|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810861|NCT01358357|P3|Participant Flow|All Subjects|During the Open-label stabilization phase, subjects received flexible does of lurasidone 20 - 80 mg daily.
810862|NCT01358357|P2|Participant Flow|Placebo|Placebo: 20-80 mg flexible dose
810863|NCT01358357|P1|Participant Flow|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810864|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810865|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810866|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810867|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810868|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810869|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810870|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810871|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810872|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810873|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810874|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810875|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810876|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810877|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810878|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810879|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810880|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810881|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810882|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810883|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810884|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810885|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810886|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810887|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810888|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810889|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810890|NCT01358357|O2|Outcome|Placebo|Placebo: 20-80 mg flexible dose
810891|NCT01358357|O1|Outcome|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810892|NCT01358357|E3|Reported Event|All Subjects|During the open-label stabilization phase, subjects received flexible does of lurasidone 20-80 mg daily
810893|NCT01358357|E2|Reported Event|Placebo|Placebo: 20-80 mg flexible dose
810894|NCT01358357|E1|Reported Event|Lurasidone 20-80 mg Flexible Dose|Lurasidone: Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
810895|NCT01358175|B4|Baseline|Total|Total of all reporting groups
810896|NCT01358175|B3|Baseline|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810897|NCT01358175|B2|Baseline|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810898|NCT01358175|B1|Baseline|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810899|NCT01358175|P3|Participant Flow|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810900|NCT01358175|P2|Participant Flow|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810904|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810905|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810906|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810907|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810908|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810909|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810910|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810911|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810912|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810913|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810914|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810915|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810916|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810917|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810918|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810919|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810920|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810921|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810922|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810923|NCT01358175|O3|Outcome|Placebo|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12
810924|NCT01358175|O2|Outcome|Secukinumab 10 mg/kg i.v. / 150 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810925|NCT01358175|O1|Outcome|Secukinumab 10 mg/kg i.v. / 75 mg s.c.|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810926|NCT01358175|E7|Reported Event|Placebo Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 150 mg
810927|NCT01358175|E6|Reported Event|Placebo Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 24 to Secukinumab 75 mg
810928|NCT01358175|E5|Reported Event|Placebo Non-Resp Secukinumab 150 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 150 mg
810929|NCT01358175|E4|Reported Event|Placebo Non-Resp Secukinumab 75 mg|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 re-randomized non-responder week 16 to Secukinumab 75 mg
810930|NCT01358175|E3|Reported Event|Placebo Secukinumab|Placebo iv at baseline, Week 2 and Week 4, and then placebo sc at Week 8 and Week 12 up to end of Study
810931|NCT01358175|E2|Reported Event|Secukinumab 10mg/kg -150 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810932|NCT01358175|E1|Reported Event|Secukinumab 10mg/kg -75 mg|Three i.v. infusions: at Baseline and weeks 2 and 4, followed by one s.c. injection every four weeks until the end of the study.
810933|NCT01357980|B5|Baseline|Total|Total of all reporting groups
810934|NCT01357980|B4|Baseline|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810935|NCT01357980|B3|Baseline|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810936|NCT01357980|B2|Baseline|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810937|NCT01357980|B1|Baseline|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810938|NCT01357980|P4|Participant Flow|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810939|NCT01357980|P3|Participant Flow|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810940|NCT01357980|P2|Participant Flow|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810941|NCT01357980|P1|Participant Flow|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810942|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810943|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810944|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
812959|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
810947|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810948|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810949|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810950|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810951|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810952|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810953|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810954|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810955|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810956|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810957|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810958|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810959|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810960|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810961|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810962|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810963|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810964|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810965|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810966|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810967|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810968|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810969|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810970|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810971|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810972|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810973|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810974|NCT01357980|O4|Outcome|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810975|NCT01357980|O3|Outcome|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810976|NCT01357980|O2|Outcome|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810977|NCT01357980|O1|Outcome|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U intra detrusor injection on day 1 (single dose)
810978|NCT01357980|E4|Reported Event|Placebo (30 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810979|NCT01357980|E3|Reported Event|Dysport 750 U (30 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
810980|NCT01357980|E2|Reported Event|Placebo (15 Injection Sites)|Placebo: Intra detrusor injection on day 1 (single dose)
810981|NCT01357980|E1|Reported Event|Dysport 750 U (15 Injection Sites)|Botulinum type A toxin (Dysport®): 750 U using different administration regimen, intra detrusor injection on day 1 (single dose)
810982|NCT01357889|B3|Baseline|Total|Total of all reporting groups
810983|NCT01357889|B2|Baseline|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810984|NCT01357889|B1|Baseline|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811238|NCT01357239|E4|Reported Event|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811241|NCT01357239|E1|Reported Event|Placebo|2 capsules of placebo per intake
810985|NCT01357889|P2|Participant Flow|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810986|NCT01357889|P1|Participant Flow|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810987|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
810988|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
810989|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
810990|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
810991|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810992|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810993|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810994|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810995|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811040|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811041|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
810996|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810997|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810998|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
810999|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811000|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811001|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811002|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811003|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811042|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811043|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811044|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811004|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811005|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811006|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811007|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811008|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811009|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811010|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811011|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811012|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811013|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811014|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811015|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811016|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811017|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811018|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 milligrams (mg) from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811019|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811045|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811046|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811047|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811239|NCT01357239|E3|Reported Event|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811020|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811021|NCT01357889|O2|Outcome|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811022|NCT01357889|O1|Outcome|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811023|NCT01357889|E2|Reported Event|Albiglutide Process 3|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 3 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811024|NCT01357889|E1|Reported Event|Albiglutide Process 2|During the BE Phase, participants received a single dose of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen. After completing the BE phase, participants progressed into the Multiple-dose Phase of the study, beginning at Week 5, during which participants received 12 weekly injections of albiglutide 30 mg from the Process 2 drug product, injected subcutaneously into the abdomen, alternating between the right and left sides of the body, using a fixed-dose, prefilled, single-use injector pen. Additional participants (other than those completing the BE Phase and progressing to the Multiple-dose Phase) were randomized into the Multiple-dose Phase of the study. All participants returned for the 8-week post-treatment follow-up visit.
811025|NCT01357850|B5|Baseline|Total|Total of all reporting groups
811026|NCT01357850|B4|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811027|NCT01357850|B3|Baseline|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811028|NCT01357850|B2|Baseline|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811029|NCT01357850|B1|Baseline|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811030|NCT01357850|P4|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811031|NCT01357850|P3|Participant Flow|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811032|NCT01357850|P2|Participant Flow|Albiglutide 3.75 mg|Participants received albiglutide 3.75 milligrams (mg) weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811033|NCT01357850|P1|Participant Flow|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811034|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811035|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811036|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811037|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811038|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811039|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811228|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811048|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811049|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811050|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811051|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811052|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811053|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811054|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811055|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811056|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811057|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811058|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811059|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811060|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811061|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811062|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811063|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811064|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811065|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811066|NCT01357850|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811067|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811068|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811069|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811070|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811071|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811072|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811073|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811074|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811075|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811076|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811077|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811078|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811079|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811080|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811081|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811082|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811229|NCT01357239|O3|Outcome|Placebo|2 capsules of placebo per intake
811083|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811084|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811085|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811086|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811087|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811088|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811089|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811090|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811091|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811092|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811093|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811094|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811095|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811096|NCT01357850|O4|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811097|NCT01357850|O3|Outcome|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811098|NCT01357850|O2|Outcome|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811099|NCT01357850|O1|Outcome|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811100|NCT01357850|E4|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811101|NCT01357850|E3|Reported Event|Albiglutide 15 mg|Participants received albiglutide 15 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811102|NCT01357850|E2|Reported Event|Albiglutide 3.75 mg|Participants received albiglutide 3.75 mg weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811103|NCT01357850|E1|Reported Event|Placebo|Participants received albiglutide matching placebo weekly injected subcutaneously into the abdomen using a fixed-dose, prefilled, single-use injector pen.
811104|NCT01357720|B3|Baseline|Total|Total of all reporting groups
811105|NCT01357720|B2|Baseline|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811106|NCT01357720|B1|Baseline|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811107|NCT01357720|P2|Participant Flow|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811108|NCT01357720|P1|Participant Flow|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811109|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811110|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811111|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811112|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811113|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811114|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811115|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811116|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811117|NCT01357720|O2|Outcome|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811118|NCT01357720|O1|Outcome|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811119|NCT01357720|E2|Reported Event|Tritanrix Hib/HepB + Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Week 6: single dose of Tritanrix HB+Hib Weeks 10 and 14: single doses of Quinvaxem
811120|NCT01357720|E1|Reported Event|Quinvaxem|Three-dose schedule: 6, 10 and 14 weeks of age Weeks 6, 10 and 14: single doses of Quinvaxem
811121|NCT01357655|B3|Baseline|Total|Total of all reporting groups
811122|NCT01357655|B2|Baseline|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811123|NCT01357655|B1|Baseline|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811124|NCT01357655|P2|Participant Flow|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811125|NCT01357655|P1|Participant Flow|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811126|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811127|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811128|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811129|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811130|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811131|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811132|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811133|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811134|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811135|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811136|NCT01357655|O2|Outcome|Dasatinib + SMO Antagonist (BMS-833923)|"No participants were randomized to this arm because no recommended phase 2 dose of the SMO antagonist could be determined (in a separate trial).~Dasatinib for 1 year followed by dasatinib plus SMO antagonist (BMS-833923) for 2 years followed by dasatinib alone for approximately 2 years; depending on response Dasatinib: Tablets, Oral, 100 mg, Once daily BMS-833923: Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response"
811137|NCT01357655|O1|Outcome|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, were given once daily for approximately 1 year before the study was terminated.
811138|NCT01357655|E1|Reported Event|Dasatinib|Dasatinib: Tablets, Oral, 100 mg, Once daily, approximately 1 year
811139|NCT01357616|B3|Baseline|Total|Total of all reporting groups
811140|NCT01357616|B2|Baseline|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
811141|NCT01357616|B1|Baseline|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811142|NCT01357616|P2|Participant Flow|AZOPT + TIMOLOL|Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.
811143|NCT01357616|P1|Participant Flow|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811144|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811145|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811146|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811147|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811148|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811149|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811150|NCT01357616|O2|Outcome|AZOPT + Timolol|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in the affected eye(s), followed by Timolol 0.5% ophthalmic solution, 1 drop instilled in the affected eye(s). Approximately 10 minutes separated the 2 instillations. The study drugs were instilled twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811151|NCT01357616|O1|Outcome|AZARGA|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks. Both eyes were dosed unless there was a potential safety issue to the patient in the opinion of the Investigator.
811152|NCT01357616|E2|Reported Event|AZOPT + TIMOLOL (Control Group)|"Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution, 1 drop of each component instilled in the affected eye(s), waiting approximately 10 minutes between instillation of the 2 drops. Study drugs were instilled twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% ophthalmic suspension and Timolol 0.5% ophthalmic solution"
811153|NCT01357616|E1|Reported Event|AZARGA (Test Group)|"Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension, 1 drop in the affected eye(s) dosed twice daily (9AM and 9PM) for 8 weeks.~Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension"
811154|NCT01357551|B3|Baseline|Total|Total of all reporting groups
811155|NCT01357551|B2|Baseline|Usual Care|Participants are randomized to receive usual care for 56 weeks
811156|NCT01357551|B1|Baseline|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 14 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
811157|NCT01357551|P2|Participant Flow|Usual Care|Participants receive usual care for 56 weeks
811158|NCT01357551|P1|Participant Flow|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
811159|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
811160|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist gradually decreases over time."
811161|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
811162|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
811163|NCT01357551|O2|Outcome|Usual Care|Participants receive usual care for 56 weeks
811164|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
811165|NCT01357551|O2|Outcome|Usual Care|Participants are randomized to receive usual care for 56 weeks
811166|NCT01357551|O1|Outcome|Maintenance Intervention|"Participants are randomized to a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention will involve in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time.~Interventions: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact with the interventionist will gradually taper over time."
811167|NCT01357551|E2|Reported Event|Usual Care|Participants receive usual care for 56 weeks
811168|NCT01357551|E1|Reported Event|Maintenance Intervention|"Participants receive a theoretically-informed maintenance intervention for 42 weeks, followed by 16 weeks of no intervention contact to examine sustainability. The maintenance intervention involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.~Maintenance intervention: Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time."
811169|NCT01357512|B3|Baseline|Total|Total of all reporting groups
811170|NCT01357512|B2|Baseline|no MRI|No MRI before prostate biopsies
811171|NCT01357512|B1|Baseline|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
811172|NCT01357512|P2|Participant Flow|no MRI|No MRI before prostate biopsies
811173|NCT01357512|P1|Participant Flow|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
811174|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
811175|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
811176|NCT01357512|O2|Outcome|no MRI|No MRI before prostate biopsies
811177|NCT01357512|O1|Outcome|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
811178|NCT01357512|E2|Reported Event|no MRI|No MRI before prostate biopsies
811179|NCT01357512|E1|Reported Event|MRI Done|"Subjects with MRI prior prostate biopsies~magnetic resonance imaging, Siemens: Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device"
811180|NCT01357239|B5|Baseline|Total|Total of all reporting groups
811181|NCT01357239|B4|Baseline|Placebo|2 capsules of placebo per intake
811182|NCT01357239|B3|Baseline|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811183|NCT01357239|B2|Baseline|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811184|NCT01357239|B1|Baseline|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811185|NCT01357239|P4|Participant Flow|Placebo|2 capsules of placebo per intake
811186|NCT01357239|P3|Participant Flow|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811187|NCT01357239|P2|Participant Flow|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811188|NCT01357239|P1|Participant Flow|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811189|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811190|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811191|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811192|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811193|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811194|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811195|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811196|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811197|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811198|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811199|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811200|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811201|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811202|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811203|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811204|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811205|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811206|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811207|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811208|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811209|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811210|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811211|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811212|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811213|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811214|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811215|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811216|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811217|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811218|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811219|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811220|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811221|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811222|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811223|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811224|NCT01357239|O1|Outcome|AFQ056 25 mg Bid|1 capsule of 25 mg and 1 capsule of placebo per intake
811225|NCT01357239|O4|Outcome|Placebo|2 capsules of placebo per intake
811226|NCT01357239|O3|Outcome|AFQ056 100 mg Bid|1 capsule of 100 mg and 1 capsule of placebo per intake
811227|NCT01357239|O2|Outcome|AFQ056 50 mg Bid|2 capsules of 25 mg per intake
811242|NCT01357148|B1|Baseline|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
811243|NCT01357148|P1|Participant Flow|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
811244|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
811245|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|
811246|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
811247|NCT01357148|O1|Outcome|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
811248|NCT01357148|E1|Reported Event|Sitagliptin Phosphate/Metformin HCl|Participants prescribed sitagliptin phosphate/metformin HCl in routine clinical practice.
811249|NCT01357135|B4|Baseline|Total|Total of all reporting groups
811250|NCT01357135|B3|Baseline|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
811251|NCT01357135|B2|Baseline|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
811252|NCT01357135|B1|Baseline|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
811253|NCT01357135|P3|Participant Flow|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
811254|NCT01357135|P2|Participant Flow|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
811255|NCT01357135|P1|Participant Flow|Metformin + Sitagliptin|Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
811256|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
811257|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
811258|NCT01357135|O2|Outcome|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
811259|NCT01357135|O1|Outcome|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
811260|NCT01357135|E3|Reported Event|Sitagliptin +/- Other Antihyperglycemic Medication|Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
811261|NCT01357135|E2|Reported Event|Metformin + Sulfonylurea|Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
811262|NCT01357135|E1|Reported Event|Metformin + Sitagliptin|Participants taking metformin + sitagliptin as prescribed in routine clinical practice.
811263|NCT01356966|B3|Baseline|Total|Total of all reporting groups
811264|NCT01356966|B2|Baseline|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
811265|NCT01356966|B1|Baseline|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
811266|NCT01356966|P2|Participant Flow|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
811267|NCT01356966|P1|Participant Flow|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
811268|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
811269|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
811270|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
811271|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
811272|NCT01356966|O2|Outcome|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
811273|NCT01356966|O1|Outcome|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
811274|NCT01356966|E2|Reported Event|Placebo + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received 2 placebo pills twice daily and folic acid 1 mg daily
811275|NCT01356966|E1|Reported Event|Tetrahydrobiopterin + Folate|Male subjects with hypertension and chronic kidney disease stage 2 or 3 received Tetrahydrobiopterin (BH4) 200 mg twice daily and folic acid 1 mg daily
811276|NCT01356940|B3|Baseline|Total|Total of all reporting groups
811311|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811338|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811277|NCT01356940|B2|Baseline|Placebo Followed by Dalfampridine ER 10mg Bid|"• Age 18-75 inclusive, Male or Female identical placebo tablet administered bid for four weeks~Group B: identical placebo tablet administered bid for four weeks, 2 week washout, then dalfampridine ER 10mg bid for 4 weeks"
811278|NCT01356940|B1|Baseline|Dalfampridine ER 10mg Bid Followed by Placebo|"• Age 18-75 inclusive, Male or Female 4 week administration of dalfampridine ER 10mg bid~Group A: dalfampridine ER 10mg bid for 4 weeks, 2 week washout, then matching placebo for 4 weeks"
811279|NCT01356940|P2|Participant Flow|Placebo-dalfampridine ER 10mg Bid|placebo tablet administered bid for four weeks followed by 2 week washout and dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks
811280|NCT01356940|P1|Participant Flow|Dalfampridine ER 10mg Bid- Placebo|4 week administration of dalfampridine ER 10mg bid followed by 2 week washout and 4 weeks of placebo
811281|NCT01356940|O2|Outcome|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
811282|NCT01356940|O1|Outcome|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
811283|NCT01356940|E2|Reported Event|Placebo|"identical placebo tablet administered bid for four weeks~placebo: identical placebo tablet administered bid for four weeks"
811284|NCT01356940|E1|Reported Event|Dalfampridine ER 10mg Bid|"4 week administration of dalfampridine ER 10mg bid~dalfampridine ER: dalfampridine ER 10mg bid for 4 weeks"
811285|NCT01356667|B3|Baseline|Total|Total of all reporting groups
811286|NCT01356667|B2|Baseline|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
811287|NCT01356667|B1|Baseline|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
811288|NCT01356667|P2|Participant Flow|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
811289|NCT01356667|P1|Participant Flow|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
811290|NCT01356667|O2|Outcome|DARTNA|"12-week DARTNA program~DARTNA: 3-hour protocol provided 2x/week over 12 weeks"
811291|NCT01356667|O1|Outcome|Treatment-As-Usual|"Substance Abuse treatment typically received~Treatment-As-Usual: Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions."
811292|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
811293|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
811294|NCT01356667|O2|Outcome|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
811295|NCT01356667|O1|Outcome|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
811296|NCT01356667|E2|Reported Event|Drum-Assisted Recovery Therapy for Native Americans|12-week treatment protocol consisting of drum therapy for Native Americans
811297|NCT01356667|E1|Reported Event|Treatment-As-Usual|Substance Abuse treatment typically received at United American Indian Involvement (UAII)
811298|NCT01356602|B4|Baseline|Total|Total of all reporting groups
811299|NCT01356602|B3|Baseline|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811300|NCT01356602|B2|Baseline|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811301|NCT01356602|B1|Baseline|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811302|NCT01356602|P3|Participant Flow|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811303|NCT01356602|P2|Participant Flow|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811304|NCT01356602|P1|Participant Flow|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811305|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811306|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811307|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811308|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811309|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811310|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811312|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811313|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811314|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811315|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811316|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811317|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811318|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811319|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811320|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811321|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811322|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811323|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811324|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811325|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811326|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811327|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811328|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811329|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811330|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811331|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811332|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811333|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811334|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811335|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811336|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811337|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811339|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811340|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811341|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811342|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811343|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811344|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811345|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811346|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811347|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811348|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811349|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811350|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811351|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811352|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811353|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811354|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811355|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811356|NCT01356602|O3|Outcome|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811357|NCT01356602|O2|Outcome|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811358|NCT01356602|O1|Outcome|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811359|NCT01356602|E3|Reported Event|Triamcinolone Acetonide|The patients on this arm received 40 mg intramuscular (i.m.) at randomization and upon new flare. The patients were given 3 injections: two placebo and one active drug.
811360|NCT01356602|E2|Reported Event|Canakinumab, Lyophilizate (LYO)|The patients on this arm received 150 mg s.c. at randomization and upon new flare. The doses were provided as lyophilized power and had to be reconstituted with water for injection before application. The patients were given 3 injections: two placebo and one active drug.
811361|NCT01356602|E1|Reported Event|Canakinumab, Pre-filled Syringes (PFS)|Patients on this arm received 150 mg subcutaneously (s.c.) at randomization and upon new flare. The doses were provided as pre-filled syringes. The patients were given 3 injections: two placebo and one active drug.
811362|NCT01356589|B1|Baseline|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
811611|NCT01355224|O5|Outcome|High Lifestyle Risk Feedback|Lifestyle feedback arm; had elevated risk for obesity based on lifestyle behavior alone.
811390|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
811363|NCT01356589|P1|Participant Flow|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
811364|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
811365|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
811366|NCT01356589|O1|Outcome|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
811367|NCT01356589|E1|Reported Event|Mircera|Participants with renal anemia due to chronic kidney disease (CKD) in pre-dialysis (Stage 3-4) and dialysis (Stage 5) were treated with Mircera according to the label for at least 9 months. This non-interventional study did not affect by any means the treatment, medical care or monitoring of the participant, since it reported 9-month retrospective data, which already existed in the participants’ medical files.
811368|NCT01356498|B7|Baseline|Total|Total of all reporting groups
811369|NCT01356498|B6|Baseline|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811370|NCT01356498|B5|Baseline|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811371|NCT01356498|B4|Baseline|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811372|NCT01356498|B3|Baseline|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
811373|NCT01356498|B2|Baseline|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811374|NCT01356498|B1|Baseline|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
811375|NCT01356498|P6|Participant Flow|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811376|NCT01356498|P5|Participant Flow|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811377|NCT01356498|P4|Participant Flow|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811378|NCT01356498|P3|Participant Flow|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
811379|NCT01356498|P2|Participant Flow|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811380|NCT01356498|P1|Participant Flow|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
811381|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811382|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811383|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811384|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
811385|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811386|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
811387|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811388|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811389|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
812960|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
811391|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811392|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
811393|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in RCT, initiated pegloticase treatment q4 wk in OLE
811394|NCT01356498|O5|Outcome|q4 RCT, Non-responder|Non-responder in Pegloticase every 4 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
811395|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
811396|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in RCT, initiated pegloticase treatment q2 wk in OLE
811397|NCT01356498|O2|Outcome|q4 RCT Responder|REsponder in Pegloticase every 4 wk arm of RCT, contuned to received pegloticase (q2 wk or q4 wk) in OLE
811398|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of RCT, continued to received pegloticase (q2 wk or q4 wk) in OLE
811399|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811400|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811401|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811402|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
811403|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811404|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
811405|NCT01356498|O6|Outcome|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811406|NCT01356498|O5|Outcome|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811407|NCT01356498|O4|Outcome|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811408|NCT01356498|O3|Outcome|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
811409|NCT01356498|O2|Outcome|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811410|NCT01356498|O1|Outcome|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
811411|NCT01356498|E6|Reported Event|Placebo in RCT, q4 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811412|NCT01356498|E5|Reported Event|q4 RCT Non-responder|Non-responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811413|NCT01356498|E4|Reported Event|q2 RCT, Non-responder|Non-responder in Pegloticase every 2 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811414|NCT01356498|E3|Reported Event|Placebo in RCT, q2 in OLE|Placebo arm in Randomized Controlled Trial (RCT), initiated pegloticase treatment every 2 weeks (q2 wk)in Open Label Extension (OLE) study
811415|NCT01356498|E2|Reported Event|q4 RCT, Responder|Responder in Pegloticase every 4 wk arm of Randomized Controlled Trial, continued to receive pegloticase every 2 weeks (q2 wk)or every 4 weeks (q4 wk)in Open Label Extension (OLE) study
811416|NCT01356498|E1|Reported Event|q2 RCT, Responder|Responder in Pegloticase every 2 wk arm of Randomized Controlled Trial (RCT), continued to receive pegloticase every 2 weeks (q2 wk) or every 4 weeks (q4 wk) in Open Label Extension (OLE) study
811417|NCT01356407|B3|Baseline|Total|Total of all reporting groups
811418|NCT01356407|B2|Baseline|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811419|NCT01356407|B1|Baseline|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811420|NCT01356407|P2|Participant Flow|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811421|NCT01356407|P1|Participant Flow|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811422|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811612|NCT01355224|O4|Outcome|Low Lifestyle Risk Feedback|Lifestyle feedback arm; did not have elevated risk for obesity based on lifestyle behavior alone.
811423|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811424|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811425|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811426|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811427|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811428|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811429|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811430|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811431|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811432|NCT01356407|O2|Outcome|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811433|NCT01356407|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811434|NCT01356407|E2|Reported Event|Hengkang Zhengqing (PEG-ELS)|PEG-ELS was used according to the approved labeled dosage and administration instructions. Only received one dose of 2 boxes (6 packets), administrated on the day of colonoscopy examination.
811435|NCT01356407|E1|Reported Event|PICOPREP|"“Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day before the colonoscopy."
811436|NCT01356147|B3|Baseline|Total|Total of all reporting groups
811437|NCT01356147|B2|Baseline|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
811438|NCT01356147|B1|Baseline|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
811439|NCT01356147|P2|Participant Flow|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
811440|NCT01356147|P1|Participant Flow|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
811441|NCT01356147|O2|Outcome|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
811442|NCT01356147|O1|Outcome|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
811443|NCT01356147|E2|Reported Event|Dornase Alfa|"Dornase alfa 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation~Dornase alfa: 2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation"
811444|NCT01356147|E1|Reported Event|Sham Placebo|"No therapy will be given to placebo arm. Respiratory therapist will shield infant from view and nebulize saline solution into incubator rather than into ventilator circuit.~Placebo: No therapy will be given to placebo arm"
811445|NCT01355978|B1|Baseline|Noninvasive Open Ventilation System|Portable noninvasive open ventilator & nasal interface. Noninvasive Open Ventilation System used during activities of daily living.
811446|NCT01355978|P1|Participant Flow|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
811447|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
811448|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
811449|NCT01355978|O1|Outcome|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
811450|NCT01355978|E1|Reported Event|Noninvasive Open Ventilation System|"Portable noninvasive open ventilator & nasal interface.~Noninvasive Open Ventilation System: Noninvasive ventilation system"
811451|NCT01355705|B1|Baseline|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
811452|NCT01355705|P1|Participant Flow|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
811469|NCT01355627|P1|Participant Flow|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
811453|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
811454|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
811455|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2~Amrubicin: 40, 60, or 80 mg/m2 intravenous (IV)~Lenalidomide: 15 mg daily by mouth~Dexamethasone: 40 mg weekly by mouth~Aspirin: 81 or 325 mg daily by mouth~Pegfilgrastim: 6 mg subcutaneous on Day 2"
811456|NCT01355705|O1|Outcome|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
811457|NCT01355705|E1|Reported Event|Amrubicin + Lenalidomide + Dexamethasone|"Amrubicin 40, 60, or 80 mg/m2 intravenous (IV) will be given intravenously on Day 1 of each 3-week cycle beginning with 40 mg/m2, for a maximum of 4 cycles.~Concurrent therapeutic medications:~Lenalidomide: 10 or 15 mg daily by mouth, Days 1 to 14~Dexamethasone: 40 mg weekly by mouth (Days 1, 8, and 15)~Other drugs:~Aspirin: 81 or 325 mg daily oral~Pegfilgrastim subcutaneous on Day 2"
811458|NCT01355679|B1|Baseline|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
811459|NCT01355679|P1|Participant Flow|Guided Therapy|"A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).~Guided Therapy: A total of 14 neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for disease response, progression and safety. All patients will be"
811460|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
811461|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
811462|NCT01355679|O1|Outcome|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
811463|NCT01355679|O1|Outcome|Guided Therapy|All subjects receive guided therapy in therapeutic combination (up to 4 agents) provided it includes medications contained in the study report.
811464|NCT01355679|E1|Reported Event|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
811465|NCT01355627|B3|Baseline|Total|Total of all reporting groups
811466|NCT01355627|B2|Baseline|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
811467|NCT01355627|B1|Baseline|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
811468|NCT01355627|P2|Participant Flow|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
811470|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
811471|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
811472|NCT01355627|O2|Outcome|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
811473|NCT01355627|O1|Outcome|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
811474|NCT01355627|E2|Reported Event|Current Practice Group|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. In addition to primary suture, whatever means of dura closure treatment, alone or in combination, as deemed necessary by the investigator was used with the exception of TachoSil®.
811475|NCT01355627|E1|Reported Event|TachoSil®|Primary suture was performed. Duraplasty could be performed at the discretion of the investigator. TachoSil® was applied under aseptic conditions during the closure of the dura.
811476|NCT01355588|B5|Baseline|Total|Total of all reporting groups
811477|NCT01355588|B4|Baseline|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
811478|NCT01355588|B3|Baseline|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
811479|NCT01355588|B2|Baseline|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
811480|NCT01355588|B1|Baseline|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
811481|NCT01355588|P4|Participant Flow|Treatment D, Treatment A, Treatment B, Treatment C|Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
811482|NCT01355588|P3|Participant Flow|Treatment C, Treatment B, Treatment A, Treatment D|Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
811483|NCT01355588|P2|Participant Flow|Treatment B, Treatment D, Treatment C, Treatment A|Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
811484|NCT01355588|P1|Participant Flow|Treatment A, Treatment C, Treatment D, Treatment B|Treatment A: Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN), then; Treatment C: Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN, then; Treatment D: 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN, then; Treatment B: Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
811485|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
811486|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
811487|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
811488|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
811489|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
811490|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
811491|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
811493|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
811494|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
811495|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
811496|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
811497|NCT01355588|O4|Outcome|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
811498|NCT01355588|O3|Outcome|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
811499|NCT01355588|O2|Outcome|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
811500|NCT01355588|O1|Outcome|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
811501|NCT01355588|E4|Reported Event|Ketorolac Tromethamine With 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
811502|NCT01355588|E3|Reported Event|Ketorolac Tromethamine With 5% Lidocaine HCl|Ketorolac Tromethamine with 5% Lidocaine HCl : 30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
811503|NCT01355588|E2|Reported Event|Ketorolac Tromethamine With 4% Lidocaine Hydrochloride (HCl)|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl) : 30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
811504|NCT01355588|E1|Reported Event|Ketorolac Tromethamine|Ketorolac Tromethamine : 30 mg Ketorolac Tromethamine intranasal (IN)
811505|NCT01355523|B3|Baseline|Total|Total of all reporting groups
811506|NCT01355523|B2|Baseline|Placebo|6 mg oral placebo daily
811507|NCT01355523|B1|Baseline|Melatonin|6 mg oral melatonin daily
811508|NCT01355523|P2|Participant Flow|Placebo|6 mg oral placebo daily
811509|NCT01355523|P1|Participant Flow|Melatonin|6 mg oral melatonin daily
811510|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811511|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811512|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811513|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811514|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811515|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811516|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811517|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811518|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811519|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811520|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811521|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811522|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811523|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811524|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811525|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811526|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811527|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811528|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811529|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811530|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811531|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811532|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811533|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811534|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811535|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811536|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811537|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811538|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811539|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811540|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811541|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811542|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811543|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811544|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811545|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811546|NCT01355523|O2|Outcome|Placebo|6 mg oral placebo daily
811547|NCT01355523|O1|Outcome|Melatonin|6 mg oral melatonin daily
811548|NCT01355523|E2|Reported Event|Placebo|6 mg oral placebo daily
811549|NCT01355523|E1|Reported Event|Melatonin|6 mg oral melatonin daily
811550|NCT01355484|B3|Baseline|Total|Total of all reporting groups
811551|NCT01355484|B2|Baseline|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
811552|NCT01355484|B1|Baseline|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
811553|NCT01355484|P2|Participant Flow|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
811554|NCT01355484|P1|Participant Flow|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
811555|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
811556|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
812317|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
811557|NCT01355484|O2|Outcome|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
811558|NCT01355484|O1|Outcome|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
811559|NCT01355484|E2|Reported Event|Placebo|"subject will receive placebo for the duration of the trial~placebo: subject will receive placebo for the duration of the trial"
811560|NCT01355484|E1|Reported Event|GTx-024|"subject will receive GTx-024 treatment for the duration of the trial~GTx-024: subjects will be randomized to receive GTx-024 for the full duration of the trial."
811561|NCT01355471|B3|Baseline|Total|Total of all reporting groups
811562|NCT01355471|B2|Baseline|Placebo|
811563|NCT01355471|B1|Baseline|CD07805/47 Gel|
811564|NCT01355471|P2|Participant Flow|Placebo|
811565|NCT01355471|P1|Participant Flow|CD07805/47 Gel|
811566|NCT01355471|O2|Outcome|Placebo|
811567|NCT01355471|O1|Outcome|CD07805/47 Gel|
811568|NCT01355471|E2|Reported Event|Placebo|
811569|NCT01355471|E1|Reported Event|CD07805/47 Gel|
811570|NCT01355458|B3|Baseline|Total|Total of all reporting groups
811571|NCT01355458|B2|Baseline|Placebo|
811572|NCT01355458|B1|Baseline|CD07805/47 Gel|
811573|NCT01355458|P2|Participant Flow|Placebo|
811574|NCT01355458|P1|Participant Flow|CD07805/47 Gel|
811575|NCT01355458|O2|Outcome|Placebo|
811576|NCT01355458|O1|Outcome|CD07805/47 Gel|
811577|NCT01355458|E2|Reported Event|Placebo|
811578|NCT01355458|E1|Reported Event|CD07805/47 Gel|
811579|NCT01355419|B1|Baseline|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
811580|NCT01355419|P1|Participant Flow|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
811581|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
811582|NCT01355419|O1|Outcome|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
811583|NCT01355419|E1|Reported Event|Obstructive Sleep Apnea, CPAP|moderate to severe obstructive sleep apnea requiring CPAP therapy
811584|NCT01355302|B1|Baseline|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
811585|NCT01355302|P3|Participant Flow|Phase 2: Capecitabine + Cisplatin|Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes.
811586|NCT01355302|P2|Participant Flow|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
811587|NCT01355302|P1|Participant Flow|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
811588|NCT01355302|O2|Outcome|Phase 2: Capecitabine + Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
811589|NCT01355302|O1|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
811590|NCT01355302|O2|Outcome|Phase 2: Capecitabine + Cisplatin|"The dose of golvatinib was to be the MTD as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
811591|NCT01355302|O1|Outcome|Phase 2: Golvatinib+Capecitabine+Cisplatin|"The dose of golvatinib was to be the maximum tolerated dose (MTD) as determined during the Phase 1b portion of the study in combination with capecitabine and cisplatin as described for Phase 1b.~The study was terminated prior to Phase 2."
811613|NCT01355224|O3|Outcome|High Genetic Risk Feedback|Genetic feedback arm; had elevated risk for obesity based on FTO alone.
811614|NCT01355224|O2|Outcome|Low Genetic Risk Feedback|Genetic feedback arm; did not have elevated risk for obesity based on FTO alone.
811615|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
811660|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
811592|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
811593|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
811594|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by IV infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a DLT in the first 3 participants.
811595|NCT01355302|O1|Outcome|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
811596|NCT01355302|E1|Reported Event|Phase 1b: Golvatinib+Capecitabine+Cisplatin|Oral golvatinib (200 mg) was taken at about the same time each day of every 21-day treatment cycle, with or without food. Oral capecitabine (1000 mg/m^2 tablet) was taken twice a day (2000 mg/m^2 total daily) with food at about the same time (after golvatinib), on Days 1 through 14 of each 21-day cycle. At least 2 hours after capecitabine was taken, cisplatin (80 mg/m^2) was administered by intravenous (IV) infusion over 60 minutes (after appropriate hydration or according to the institutional guidelines), on Day 1 of each 21-day cycle. Pretreatment hydration included 1 liter of normal saline by IV infusion over 120 minutes. Posttreatment hydration included 500 mL normal saline over 60 minutes. The dose level of golvatinib was to be escalated (to 300 and 400 mg) for additional cohorts after 3 participants enrolled into a given cohort unless there was a dose-limiting toxicity (DLT) in the first 3 participants.
811597|NCT01355224|B5|Baseline|Total|Total of all reporting groups
811598|NCT01355224|B4|Baseline|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
811599|NCT01355224|B3|Baseline|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
811600|NCT01355224|B2|Baseline|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
811601|NCT01355224|B1|Baseline|No Risk Feedback|No risk feedback for obesity was provided.
811602|NCT01355224|P4|Participant Flow|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
811603|NCT01355224|P3|Participant Flow|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
811604|NCT01355224|P2|Participant Flow|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
811605|NCT01355224|P1|Participant Flow|No Risk Feedback|No risk feedback for obesity was provided.
811606|NCT01355224|O5|Outcome|High Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; Had elevated risk for obesity based on lifestyle behavior.
811607|NCT01355224|O4|Outcome|High Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Had elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
811608|NCT01355224|O3|Outcome|Low Genetic Risk + High Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; had elevated risk for obesity based on lifestyle behavior.
811609|NCT01355224|O2|Outcome|Low Genetic Risk + Low Lifestyle Risk Feedback|Feedback received: Did not have elevated risk for obesity based on FTO; did not have elevated risk for obesity based on lifestyle behavior.
811610|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
811616|NCT01355224|O4|Outcome|Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.~Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV)."
811617|NCT01355224|O3|Outcome|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates presented based on individuals' risk for obesity due to personal lifestyle factors (specifically, hours sitting while watching TV).
811618|NCT01355224|O2|Outcome|Genetic Risk Feedback|FTO variant: Relative risk estimates presented based on individuals' risk for obesity from genotype results.
811619|NCT01355224|O1|Outcome|No Risk Feedback|Control - no obesity risk feedback provided.
811620|NCT01355224|E4|Reported Event|Both Genetic and Lifestyle Risk Feedback|"FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.~Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors."
811621|NCT01355224|E3|Reported Event|Lifestyle Risk Feedback|Lifestyle: Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
811622|NCT01355224|E2|Reported Event|Genetic Risk Feedback|FTO variant: Relative risk estimates will be presented based on individuals'risk for obesity based on genotype results.
811623|NCT01355224|E1|Reported Event|No Risk Feedback|Control arm - no obesity risk feedback provided
811624|NCT01355081|B4|Baseline|Total|Total of all reporting groups
811625|NCT01355081|B3|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811626|NCT01355081|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811627|NCT01355081|B1|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811628|NCT01355081|P3|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811629|NCT01355081|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811630|NCT01355081|P1|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811631|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811632|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811633|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811634|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811635|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811636|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811637|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811638|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811639|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811640|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811641|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811642|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811643|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811644|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811645|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811646|NCT01355081|O3|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811647|NCT01355081|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811648|NCT01355081|O1|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811649|NCT01355081|E3|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 8 weeks.
811650|NCT01355081|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for up to 8 weeks.
811651|NCT01355081|E1|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for up to 8 weeks.
811652|NCT01355068|B1|Baseline|Entire Study Population|Includes participants randomized to receive Epanutin (phenytoin) infatabs 50 mg first and Dilantin (phenytoin) infatabs 50 mg first.
811653|NCT01355068|P2|Participant Flow|Dilantin Infatabs 50 mg First, Then Epanutin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in first intervention period; and single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
811654|NCT01355068|P1|Participant Flow|Epanutin Infatabs 50 mg First, Then Dilantin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 milligram (mg) chewable tablet in first intervention period; and single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet in second intervention period. A washout period of at least 7 days was maintained between each period.
811655|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
811656|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
811657|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
811658|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
811659|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
811661|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
811662|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
811663|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
811664|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
811665|NCT01355068|O2|Outcome|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
811666|NCT01355068|O1|Outcome|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
811667|NCT01355068|E2|Reported Event|Dilantin Infatabs 50 mg|Single oral dose of Dilantin (phenytoin) infatabs 50 mg chewable tablet (Test) in either first intervention period or second intervention period.
811668|NCT01355068|E1|Reported Event|Epanutin Infatabs 50 mg|Single oral dose of Epanutin (phenytoin) infatabs 50 mg chewable tablet (Reference) in either first intervention period or second intervention period.
811669|NCT01354990|B1|Baseline|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
811670|NCT01354990|P1|Participant Flow|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
811671|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
811672|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
811673|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
811674|NCT01354990|O1|Outcome|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
811675|NCT01354990|E1|Reported Event|Sitagliptin Phosphate (JANUVIA®)|Participants prescribed Sitagliptin Phosphate (JANUVIA®) in routine clinical practice.
811676|NCT01354938|B1|Baseline|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
811677|NCT01354938|P1|Participant Flow|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
811678|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
811679|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
811680|NCT01354938|O1|Outcome|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
811681|NCT01354938|E1|Reported Event|Acute Exacerbation of Chronic Bronchitis (AECB)|Participants with a diagnosis of chronic bronchitis and signs and symptoms of an acute exacerbation who were prescribed Klaricid XL (500 mg of modified release clarithromycin) at a dose of one tablet once a day or two tablets once a day, based on physician's decision of severity of symptoms, per routine clinical care.
811682|NCT01354899|B1|Baseline|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
811683|NCT01354899|P1|Participant Flow|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
811732|NCT01354314|P2|Participant Flow|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811733|NCT01354314|P1|Participant Flow|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811734|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811684|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
811685|NCT01354899|O1|Outcome|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
811686|NCT01354899|E1|Reported Event|Window|"WindowTM is a protective layer that may reduce the shear and friction on the skin and may help to prevent skin breakdown. Window TM provides instant tack adhesion that minimizes the requirement of extra pressure in order to fixate well. The product does not leave residues and the adhesion level does not increase over time.~Critically ill subjects treated within intensive care have a high risk to developing pressure ulcers, this is because they are almost invariably limited in their overall physical activity changing their position in bed and it is very common with impaired circulation and/or using specific medication which also can lead to high risk of developing pressure ulcer."
811687|NCT01354652|B4|Baseline|Total|Total of all reporting groups
811688|NCT01354652|B3|Baseline|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
811689|NCT01354652|B2|Baseline|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811690|NCT01354652|B1|Baseline|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811691|NCT01354652|P3|Participant Flow|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
811692|NCT01354652|P2|Participant Flow|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811693|NCT01354652|P1|Participant Flow|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811694|NCT01354652|O3|Outcome|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
811695|NCT01354652|O2|Outcome|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811696|NCT01354652|O1|Outcome|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811697|NCT01354652|E3|Reported Event|no NRTI Group|hepatitis C virus associated LC patients for the calculation of lactic acidosis incidence
811698|NCT01354652|E2|Reported Event|Lamivudine|"Oral 100mg/day lamivudine until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811699|NCT01354652|E1|Reported Event|Entecavir|"Oral 0.5mg/day until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18.~Participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~entecavir, lamivudine: entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
811700|NCT01354431|B4|Baseline|Total|Total of all reporting groups
811701|NCT01354431|B3|Baseline|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811702|NCT01354431|B2|Baseline|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811703|NCT01354431|B1|Baseline|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until Progressive disease (PD), toxicity or discontinued for other reasons
811704|NCT01354431|P3|Participant Flow|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
811705|NCT01354431|P2|Participant Flow|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
811706|NCT01354431|P1|Participant Flow|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinued for other reasons
811707|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811708|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811709|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811710|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811711|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811712|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811713|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811714|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811715|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811716|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811717|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811718|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons
811719|NCT01354431|O3|Outcome|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
811720|NCT01354431|O2|Outcome|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
811721|NCT01354431|O1|Outcome|0.3 mg/kg Nivolumab|Nivolumab Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (q 3 weeks), until progressive disease (PD), toxicity or discontinued for other reasons.
811722|NCT01354431|E3|Reported Event|10.0 mg/kg Nivolumab|Nivolumab Solution, IV 10.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
811723|NCT01354431|E2|Reported Event|2.0 mg/kg Nivolumab|Nivolumab Solution IV, 2.0 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
811724|NCT01354431|E1|Reported Event|0.3 mg/kg Nivolumab|Nivolumab Solution, IV, 0.3 mg/kg, q 3 weeks, until PD, toxicity or discontinued for other reasons.
811725|NCT01354314|B5|Baseline|Total|Total of all reporting groups
811726|NCT01354314|B4|Baseline|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811727|NCT01354314|B3|Baseline|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811728|NCT01354314|B2|Baseline|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811729|NCT01354314|B1|Baseline|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811730|NCT01354314|P4|Participant Flow|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811731|NCT01354314|P3|Participant Flow|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811735|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811736|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811737|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811738|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811739|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811740|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811741|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811742|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811743|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811744|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811745|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811746|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811747|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811748|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811749|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811750|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811751|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811752|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811753|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811754|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811755|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811756|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811757|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811758|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811759|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811760|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811761|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811762|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811763|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811926|NCT01354132|B3|Baseline|Total|Total of all reporting groups
811764|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811765|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811766|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811767|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811768|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811769|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811770|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811771|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811772|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811773|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811774|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811775|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811776|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811777|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811778|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811779|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811780|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811781|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811782|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811783|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811784|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811785|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811786|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811787|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811788|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811789|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811790|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811791|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811792|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811793|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811794|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811795|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811796|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811797|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811798|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811799|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811800|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811801|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811802|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811803|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811804|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811805|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811806|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811807|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811808|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811809|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811810|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811811|NCT01354314|O3|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811812|NCT01354314|O2|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811813|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811814|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811815|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811816|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811817|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811818|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811819|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811820|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811821|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811822|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811823|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811996|NCT01354015|E1|Reported Event|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
811824|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811825|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811826|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811827|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811828|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811829|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811830|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811831|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811832|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811833|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811834|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811835|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811836|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811837|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811838|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811839|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811840|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811841|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811842|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811843|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811844|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811845|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811846|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811847|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811848|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811849|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811850|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811851|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811852|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811853|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811854|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811855|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811856|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811857|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811858|NCT01354314|O4|Outcome|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811859|NCT01354314|O3|Outcome|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811860|NCT01354314|O2|Outcome|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811861|NCT01354314|O1|Outcome|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811862|NCT01354314|E4|Reported Event|Placebo|"Placebos in place of fluconazole and paroxetine~Placebos: One capsule placebo #1 every 12 hours orally per day; Two capsules placebo #2 orally once daily in the evening"
811863|NCT01354314|E3|Reported Event|Fluconazole|"Fluconazole 100 mg every 12 hours orally per day; placebo in place of paroxetine every evening orally per day~Fluconazole: One 100 MG capsule taken twice daily, 12 hour dosing"
811864|NCT01354314|E2|Reported Event|Paroxetine|"Paroxetine 20 mg orally once per day; placebo in place of fluconazole every 12 hours orally per day~Paroxetine: Two 10 MG capsules paroxetine once daily in the evening"
811865|NCT01354314|E1|Reported Event|Paroxetine and Fluconazole|"Fluconazole 100 mg every 12 hours orally per day and paroxetine 20 mg every evening orally per day~Paroxetine and Fluconazole: One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening"
811866|NCT01354223|B3|Baseline|Total|Total of all reporting groups
811867|NCT01354223|B2|Baseline|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811868|NCT01354223|B1|Baseline|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811869|NCT01354223|P2|Participant Flow|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811870|NCT01354223|P1|Participant Flow|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811871|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811872|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811873|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811874|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811875|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811876|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811877|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811878|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811879|NCT01354223|O2|Outcome|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811880|NCT01354223|O1|Outcome|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811881|NCT01354223|E2|Reported Event|Ocufilcon B Contact Lens|Randomized to ocufilcon B contact lens worn in a daily wear, daily disposable mode
811882|NCT01354223|E1|Reported Event|Stenfilcon A Contact Lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
811883|NCT01354197|B3|Baseline|Total|Total of all reporting groups
811884|NCT01354197|B2|Baseline|Non-survive at Day 28|The patients who non-survived at 28 days after surgical ICU admission.
811885|NCT01354197|B1|Baseline|Survive at Day 28|The patients who survived at 28 days after surgical ICU admission.
811886|NCT01354197|P1|Participant Flow|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
811887|NCT01354197|O1|Outcome|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
811888|NCT01354197|O1|Outcome|All ICU Admission Patients|All ICU admission to surgical intensive care unit at cohort time
811889|NCT01354197|E2|Reported Event|Non-survive at Day 28|Number of participants who Did Not survive at day 28
811890|NCT01354197|E1|Reported Event|Survive at Day 28|Number of participants who survive at day 28
811891|NCT01354145|B3|Baseline|Total|Total of all reporting groups
811892|NCT01354145|B2|Baseline|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811893|NCT01354145|B1|Baseline|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811894|NCT01354145|P2|Participant Flow|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811997|NCT01353976|B3|Baseline|Total|Total of all reporting groups
811927|NCT01354132|B2|Baseline|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811895|NCT01354145|P1|Participant Flow|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811896|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811897|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811898|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811899|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811900|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811901|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811902|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811903|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811904|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811905|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811906|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811907|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811908|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811909|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811910|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811911|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811912|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811913|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811914|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811915|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811916|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811917|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811918|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811919|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811920|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811921|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811922|NCT01354145|O2|Outcome|Celecoxib (Celebrex)|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811923|NCT01354145|O1|Outcome|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811924|NCT01354145|E2|Reported Event|Celecoxib|"CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning~Celecoxib: Celecoxib 200 mg/day, 24 months treatment period"
811925|NCT01354145|E1|Reported Event|Chondroitin Sulfate (Condrosan)|"CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning~Chondroitin sulfate: Chondroitin sulphate 1200 mg/day, 24 months treatment period"
811928|NCT01354132|B1|Baseline|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811929|NCT01354132|P2|Participant Flow|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811930|NCT01354132|P1|Participant Flow|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811931|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
811932|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811933|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
811934|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811935|NCT01354132|O1|Outcome|Placebo Group|Placebo comparison group for study matching effervescent placebo tablets in water 2 in am and 1 in pm
811936|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811937|NCT01354132|O1|Outcome|Placebo Group|"Placebo comparison group for study matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811938|NCT01354132|O1|Outcome|N-acetyl-cysteine|n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
811939|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811940|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811941|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811942|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811943|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811944|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811945|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811946|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811947|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811948|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811949|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811950|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811951|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811952|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811953|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811954|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811955|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811956|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811957|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811958|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811959|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811960|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811961|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811962|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811963|NCT01354132|O2|Outcome|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811964|NCT01354132|O1|Outcome|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811965|NCT01354132|E2|Reported Event|Placebo|"matching effervescent tablets in water 2 in am and 1 in pm~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811966|NCT01354132|E1|Reported Event|N-acetyl-cysteine|"N-Acetyl cysteine effervescent tablets in water 2 in am and 1 in pm for 28 weeks~n-acetylcysteine: 900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM"
811967|NCT01354106|B1|Baseline|Infant|Investigational adhesive tape control paper tape
811968|NCT01354106|P1|Participant Flow|Adhesive Medical Tape|"Each study participant received both treatment arms: 3M Kind Removal Silicone Tape (1 x 1.5 sample, applied one time, worn 24 hours) and 3M Micropore Silicone Tape (1 x 1.5 sample, applied one ime, worn 24 hours)."
811969|NCT01354106|O2|Outcome|3M Micropore Medical Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
811970|NCT01354106|O1|Outcome|3M Kind Removal Silicone Tape|"1 x 1.5 sample applied one time, worn for 24 hours."
811971|NCT01354106|E2|Reported Event|Control Paper Tape|
811972|NCT01354106|E1|Reported Event|Investigational Adhesive Tape|
811973|NCT01354028|B1|Baseline|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
811974|NCT01354028|P2|Participant Flow|No Massage Therapy First Day, Massage Therapy Second Day|"Day one of study: No massage therapy. Actigraph in place to measure sleep for 3 hours.~Day two of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours."
811975|NCT01354028|P1|Participant Flow|Massage Therapy First Day, no Massage Therapy Second Day|"Day one of study: Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.~Day two of study: No massage therapy. Actigraph in place to measure sleep for 3 hours"
811976|NCT01354028|O2|Outcome|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
811977|NCT01354028|O1|Outcome|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
811978|NCT01354028|O2|Outcome|Heart Rate Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
811979|NCT01354028|O1|Outcome|Heart Rate During Massage|Heart rate during massage therapy
811980|NCT01354028|O2|Outcome|Oxygen Saturation Without Massage|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for heart rate, oxygen saturation, and sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times.
811981|NCT01354028|O1|Outcome|Oxygen Saturation During Massage|Oxygen saturation during massage therapy
811982|NCT01354028|O2|Outcome|Sleep Efficiency With no Massage Therapy|No intervention. This is a crossover trial. Infants received massage therapy on one day and no massage (no intervention) on the other day. They continued to be monitored for sleep efficiency using the Actigraph on the day that they received no intervention, but at corresponding times. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
811983|NCT01354028|O1|Outcome|Sleep Efficiency With Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep efficiency for 3 hours - following 9 AM feeding until approximately 12 noon.
811984|NCT01354028|E2|Reported Event|No Massage Therapy|This was a crossover trial. The infants received 10 minutes of massage therapy on one day, and no massage therapy (no intervention) the other day. On the day that infants did not receive massage therapy, they were monitored as usual with heart rate and oxygen saturation levels and with the Actigraph that measured sleep efficiency, but there was no intervention.
811985|NCT01354028|E1|Reported Event|Massage Therapy|Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
811986|NCT01354015|B3|Baseline|Total|Total of all reporting groups
811987|NCT01354015|B2|Baseline|Usual Care|Usual Care
811988|NCT01354015|B1|Baseline|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
811989|NCT01354015|P2|Participant Flow|Usual Care|Usual Care
811990|NCT01354015|P1|Participant Flow|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
811991|NCT01354015|O2|Outcome|Usual Care|Usual Care
811992|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
811993|NCT01354015|O2|Outcome|Usual Care|Usual Care
811994|NCT01354015|O1|Outcome|Use of Messaging System|"Use of DRMS~DRMS: USE OF TEXT MESSAGING SYSTEM"
811995|NCT01354015|E2|Reported Event|Usual Care|Usual Care
812138|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812010|NCT01353963|B1|Baseline|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812011|NCT01353963|P1|Participant Flow|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812012|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812013|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812014|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812015|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812016|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812017|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812018|NCT01353963|O1|Outcome|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812019|NCT01353963|E1|Reported Event|Desvenlafaxine Succinate|Participants diagnosed with major depressive disorder (MDD) or vasomotor symptoms (VMS) associated with menopause aged 18 years and above who received desvenlafaxine succinate as per the approved local product document were observed for 8 weeks in this prospective study. For MDD, the recommended dose of desvenlafaxine succinate was 50 milligram (mg) once daily and for VMS associated with menopause, the recommended dose of desvenlafaxine succinate was 100 mg once daily. Dose was adjusted solely according to medical and therapeutic necessity.
812020|NCT01353911|B9|Baseline|Total|Total of all reporting groups
812021|NCT01353911|B8|Baseline|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812022|NCT01353911|B7|Baseline|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812023|NCT01353911|B6|Baseline|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812024|NCT01353911|B5|Baseline|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812310|NCT01352845|B1|Baseline|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812025|NCT01353911|B4|Baseline|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812026|NCT01353911|B3|Baseline|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812027|NCT01353911|B2|Baseline|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812028|NCT01353911|B1|Baseline|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812029|NCT01353911|P8|Participant Flow|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812030|NCT01353911|P7|Participant Flow|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812031|NCT01353911|P6|Participant Flow|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812032|NCT01353911|P5|Participant Flow|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812033|NCT01353911|P4|Participant Flow|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812034|NCT01353911|P3|Participant Flow|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812035|NCT01353911|P2|Participant Flow|Grazoprevir 100 mg|TN non-cirrhotic (NC) participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812036|NCT01353911|P1|Participant Flow|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812037|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812038|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812039|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812040|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812041|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812042|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812043|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812044|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812045|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812046|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812047|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812048|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812049|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812050|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812051|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812052|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812053|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812054|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812055|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812056|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812057|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812058|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812059|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812060|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812061|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812062|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812063|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812064|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812065|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812066|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812067|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812068|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812069|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812070|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812071|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812072|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812073|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812074|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812075|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812076|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812311|NCT01352845|P2|Participant Flow|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812077|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812078|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812079|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812080|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812081|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812082|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812083|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812084|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812085|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812086|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812087|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812088|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812089|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812090|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812091|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812092|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812093|NCT01353911|O8|Outcome|Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812094|NCT01353911|O7|Outcome|Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812095|NCT01353911|O6|Outcome|Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812096|NCT01353911|O5|Outcome|Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812097|NCT01353911|O4|Outcome|Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812098|NCT01353911|O3|Outcome|Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812099|NCT01353911|O2|Outcome|Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812100|NCT01353911|O1|Outcome|OL Grazoprevir 100 mg|Treatment-naïve (TN) cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812101|NCT01353911|E8|Reported Event|Non-cirr: Boceprevir 800 mg|TN NC participants started a 4 week lead-in with Peg-IFN + RBV, then received Boceprevir 800 mg + Peg-IFN + RBV for 24 weeks followed by 0 or 20 weeks of Peg-IFN + RBV, based on response guided therapy.
812137|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812593|NCT01352416|B5|Baseline|Total|Total of all reporting groups
812102|NCT01353911|E7|Reported Event|Non-cirr: Grazoprevir 800 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812103|NCT01353911|E6|Reported Event|Non-cirr: Grazoprevir 400 mg/100 mg|TN NC participants initially were randomized to receive Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy. As the result of an interim analysis, these participants were unblinded and transitioned to 100 mg grazoprevir once daily + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812104|NCT01353911|E5|Reported Event|Non-cirr: Grazoprevir 800 mg|TN NC participants received Grazoprevir 800 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812105|NCT01353911|E4|Reported Event|Non-cirr: Grazoprevir 400 mg|TN NC participants received Grazoprevir 400 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812106|NCT01353911|E3|Reported Event|Non-cirr: Grazoprevir 200 mg|TN NC participants received Grazoprevir 200 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812107|NCT01353911|E2|Reported Event|Non-cirr: Grazoprevir 100 mg|TN NC participants received Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812108|NCT01353911|E1|Reported Event|Cirr: OL Grazoprevir 100 mg|TN cirrhotic participants received open-label Grazoprevir 100 mg + Peg-IFN + RBV for 12 weeks followed by 12 or 36 weeks of Peg-IFN + RBV, based on response guided therapy.
812109|NCT01353898|B7|Baseline|Total|Total of all reporting groups
812110|NCT01353898|B6|Baseline|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
812111|NCT01353898|B5|Baseline|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812112|NCT01353898|B4|Baseline|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812113|NCT01353898|B3|Baseline|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812114|NCT01353898|B2|Baseline|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812115|NCT01353898|B1|Baseline|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812116|NCT01353898|P6|Participant Flow|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
812117|NCT01353898|P5|Participant Flow|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812118|NCT01353898|P4|Participant Flow|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812119|NCT01353898|P3|Participant Flow|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812120|NCT01353898|P2|Participant Flow|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812121|NCT01353898|P1|Participant Flow|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812122|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
812123|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812124|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812125|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812126|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812127|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812128|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
812129|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812130|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812131|NCT01353898|O3|Outcome|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812132|NCT01353898|O2|Outcome|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812133|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812134|NCT01353898|O6|Outcome|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
812135|NCT01353898|O5|Outcome|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812136|NCT01353898|O4|Outcome|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812139|NCT01353898|O1|Outcome|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812140|NCT01353898|E6|Reported Event|Placebo Twice Daily (Part I)|Ten capsules containing placebo were taken orally, twice per day for 10 days (Part I)
812141|NCT01353898|E5|Reported Event|MK-1972 100 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 100 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812142|NCT01353898|E4|Reported Event|MK-1972 25 mg Twice Daily (Part I)|Ten capsules containing a total daily dose of 25 mg MK-1972 or placebo were taken orally, twice per day for 10 days (Part I)
812143|NCT01353898|E3|Reported Event|MK-1972 800 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 800 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812144|NCT01353898|E2|Reported Event|MK-1972 200 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 200 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812145|NCT01353898|E1|Reported Event|MK-1972 50 mg Once Daily (Part I)|Ten capsules containing a total daily dose of 50 mg MK-1972 or placebo were taken orally, once per day for 10 days (Part I)
812146|NCT01353859|B1|Baseline|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812147|NCT01353859|P1|Participant Flow|Tocilizumab + Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (minimum dose 480 mg, maximum dose 800 mg), intravenously (IV), once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812148|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812149|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812150|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812151|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812152|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812153|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812154|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812155|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812171|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
812172|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
812312|NCT01352845|P1|Participant Flow|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812156|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812157|NCT01353859|O1|Outcome|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812158|NCT01353859|E1|Reported Event|Tocilizumab + MTX|Participants received tocilizumab 8 mg/kg (minimum dose 480 mg, maximum dose 800 mg), IV, once every 4 weeks (maximum number of infusions received was 6) and MTX, 10-25 mg per week, at a stable dose; the dose and route of administration of MTX at entry in the study was to be continued without change while on study unless an adjustment was necessary for safety reasons. All participants treated with MTX received either folic acid or leucovorin according to the manufacturer's recommendations.
812159|NCT01353664|B1|Baseline|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
812160|NCT01353664|P1|Participant Flow|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
812161|NCT01353664|O1|Outcome|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
812162|NCT01353664|E1|Reported Event|ROMI 4|Participants received the same dose and frequency used for the last dose of romidepsin given in the preceding romidepsin study (either 8 mg/m^2 or 14 mg/m^2 on Days 1, 8 and 15 of a 28-day cycle), adjusted for any dose-limiting toxicities. For participants treated with the 4-hour infusion in their preceding romidepsin study, a change in the infusion time to 1-hour, at the dose/schedule of 10 mg/m^2 on Days 1, 8, and 15 every 28 days, was permitted upon consultation and agreement with the medical monitor.
812163|NCT01353586|B3|Baseline|Total|Total of all reporting groups
812164|NCT01353586|B2|Baseline|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
812165|NCT01353586|B1|Baseline|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
812166|NCT01353586|P2|Participant Flow|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
812167|NCT01353586|P1|Participant Flow|nMARQ™ (Main Study- Single Arm)|This group of subjects underwent electrophysiological mapping and radiofrequency ablation with the Biosense Webster nMARQ™ system. The Main Study (167 subjects) consists only of subjects treated with the nMARQ catheter.
812168|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are related for transparency; but cannot be compared statistically against the data from the Main Study group."
812169|NCT01353586|O1|Outcome|nMARQ™ System (SNA Subpopulation)|The nMARQ arm of the SNA subpopulation included 19 subjects treated with the nMARQ™ System.
812170|NCT01353586|O2|Outcome|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
812173|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
812174|NCT01353586|O1|Outcome|nMARQ™ System (Main Study - Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
812175|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
812176|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
812177|NCT01353586|O1|Outcome|nMARQ™ (Main Study- Single Arm)|The Main Study group consists of subjects who were treated with the Biosense Webster nMARQ™ system. This group is single-arm and does not include the SNA substudy population (no comparator group).
812178|NCT01353586|E2|Reported Event|NAVISTAR® THERMOCOOL® (SNA Subpopulation Only)|"Version 3.0 of the Clinical Investigation Plan added a Subpopulation Neurological Assessments (SNA) designed to evaluate post-ablation generation of cerebral microemboli and associated neurological deficits.~These assessments were done in a prospective, non-randomized manner, comparing subjects treated with the nMARQ system against control subjects treated with the NAVISTAR® THERMOCOOL® Irrigated Tip Catheter.~Per study design, the data from the NAVISTAR® THERMOCOOL® subpopulation would be used for SNA analysis only. The data in this column are presented for transparency; but cannot be compared statistically against the data from the Main Study group."
812179|NCT01353586|E1|Reported Event|nMARQ™ System (Main Study)|nMARQ™ is the Biosense Webster Pulmonary Vein Isolation System consists of Circular and Crescent Mapping and Ablation Catheters and the Multi-channel Radiofrequency Generator. This system is designed to facilitate electrophysiological mapping and transmit radiofrequency from multiple electrodes simultaneously for treating paroxysmal atrial fibrillation (PAF).
812180|NCT01353508|B5|Baseline|Total|Total of all reporting groups
812181|NCT01353508|B4|Baseline|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812182|NCT01353508|B3|Baseline|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812183|NCT01353508|B2|Baseline|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812184|NCT01353508|B1|Baseline|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812185|NCT01353508|P4|Participant Flow|Valsartan to LCZ696 - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812186|NCT01353508|P3|Participant Flow|LCZ696 to Valsartan - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812187|NCT01353508|P2|Participant Flow|Valsartan to LCZ696 - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812188|NCT01353508|P1|Participant Flow|LCZ696 to Valsartan - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812189|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812190|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812191|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812192|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812193|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812194|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812195|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812271|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812196|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812197|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812198|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812199|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812200|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812201|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812202|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812203|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812204|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812205|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812206|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812207|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812208|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812209|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812210|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812211|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812212|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812213|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812214|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812215|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812216|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812217|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812218|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812219|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812272|NCT01353274|E1|Reported Event|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812220|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812221|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812222|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812223|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812224|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812225|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812226|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812227|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812228|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812229|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812230|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812231|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812232|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812233|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812234|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812235|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812236|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812237|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812238|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812239|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812240|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812241|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812242|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812243|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812273|NCT01353222|B3|Baseline|Total|Total of all reporting groups
812657|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
812244|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812245|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812246|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812247|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812248|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812249|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812250|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812251|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812252|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812253|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812254|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812255|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812256|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812257|NCT01353508|O4|Outcome|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812258|NCT01353508|O3|Outcome|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812259|NCT01353508|O2|Outcome|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812260|NCT01353508|O1|Outcome|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812261|NCT01353508|E4|Reported Event|Valsartan - HTN Cohort|Participants in this arm received Valsartan 320 mg qd during open-label run-in, Valsartan 320 mg qd during period 1, Valsartan 320 mg qd during wash-out, and LCZ696 400 qd bid double blind treatment during period 2.
812262|NCT01353508|E3|Reported Event|LCZ696 - Hypertension (HTN) Cohort|Participants in this arm received Valsartan 320 mg once daily (qd) during open-label run-in, LCZ696 400 mg qd double blind treatment during period 1, Valsartan 320 mg qd during wash-out, and Valsartan 320 mg qd double blind treatment during period 2.
812263|NCT01353508|E2|Reported Event|Valsartan - HF Cohort|Participants in this arm received Valsartan 160 mg twice daily bid during open-label run-in, Valsartan 160 mg bid during period 1, Valsartan 160 mg bid during wash-out, and LCZ696 200 mg bid double blind treatment during period 2.
812264|NCT01353508|E1|Reported Event|LCZ696 - Heart Failure (HF) Cohort|Participants in this arm received Valsartan 160 mg twice daily (bid) during open-label run-in, LCZ696 200 mg bid double blind treatment during period 1, Valsartan 160 mg bid during wash-out, and Valsartan 160 mg bid double blind treatment during period 2.
812265|NCT01353274|B1|Baseline|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812266|NCT01353274|P1|Participant Flow|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812267|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812268|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812269|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812270|NCT01353274|O1|Outcome|Patients With Hypertension|Micamlo Combination Tablets AP: Telmisartan 40 mg plus Amlodipine 5 mg, oral administration
812274|NCT01353222|B2|Baseline|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
812275|NCT01353222|B1|Baseline|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
812276|NCT01353222|P2|Participant Flow|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin-containing chemotherapy is beneficial in the adjuvant setting for this patient population.
812277|NCT01353222|P1|Participant Flow|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
812278|NCT01353222|O2|Outcome|Standard of Care|"Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.~Standard of Care: Standard of care"
812279|NCT01353222|O1|Outcome|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
812280|NCT01353222|E2|Reported Event|Standard of Care|Subjects randomized to the control arm were treated per standard of care, which in this patient population is generally observation, as there is currently no evidence that treatment with non-cisplatin containing chemotherapy is beneficial in the adjuvant setting for this patient population.
812281|NCT01353222|E1|Reported Event|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
812282|NCT01353144|B3|Baseline|Total|Total of all reporting groups
812283|NCT01353144|B2|Baseline|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
812284|NCT01353144|B1|Baseline|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
812285|NCT01353144|P2|Participant Flow|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
812286|NCT01353144|P1|Participant Flow|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
812287|NCT01353144|O2|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
812288|NCT01353144|O1|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
812289|NCT01353144|O2|Outcome|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
812290|NCT01353144|O1|Outcome|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
812291|NCT01353144|E2|Reported Event|Esomeprazole Plus Aspirin|"esomeprazole (40 mg/day) plus aspirin (100 mg/day) for 8 weeks~aspirin: aspirin, 100 mg, qd x 8 weeks"
812292|NCT01353144|E1|Reported Event|Esomeprazole|esomeprazole (40 mg/day) for 8 weeks
812293|NCT01353079|B3|Baseline|Total|Total of all reporting groups
812294|NCT01353079|B2|Baseline|Glycero-COCAs|Placebo: Glycero-COCAS sublingual
812295|NCT01353079|B1|Baseline|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
812296|NCT01353079|P2|Participant Flow|Glycero-COCAs|Placebo-Glycero-COCAs sublingual
812297|NCT01353079|P1|Participant Flow|Short Ragweed Pollen Allergenic Extract|"Allergy Immunotherapy: Daily administration of Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
812298|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
812299|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
812300|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
812301|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
812302|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
812303|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of Short Ragweed Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
812304|NCT01353079|O2|Outcome|Placebo (Glycero-Cocas)|Placebo: Glycero-COCAs sublingual
812305|NCT01353079|O1|Outcome|Ragweed Allergenic Extract|"Allergy Immunotherapy: Daily sublingual administration of ragweed allergenic extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.~Short Ragweed Allergenic Extract: Active-Short Ragweed Allergenic Extract sublingual"
812306|NCT01353079|E2|Reported Event|Glycero-Cocas|placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual
812307|NCT01353079|E1|Reported Event|Ragweed Allergenic Extract|"allergy immunotherapy: Daily administration of ragweed allergenic extract up to 42U Amb a 1 for a minimum of 8 week prior to the ragweed pollen season.~placebo and short ragweed allergenic extract: Active- short ragweed allergenic extract sublingual Placebo-Glycero-Cocas sublingual"
812308|NCT01352845|B3|Baseline|Total|Total of all reporting groups
812318|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812319|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812320|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812321|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812322|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812323|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812324|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812325|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812326|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812327|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812328|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812329|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812330|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812331|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812332|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812333|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812334|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812335|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812336|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812337|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812338|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812339|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812340|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812341|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812342|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812343|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812344|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812345|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812346|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812347|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812348|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812349|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812350|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812351|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812352|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812353|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812354|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812355|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812356|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812357|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812358|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812359|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812360|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812361|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812362|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812363|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812364|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812365|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812366|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812367|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812368|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812369|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812370|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812371|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812372|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812373|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812374|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812375|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812376|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812378|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812379|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812380|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812381|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812382|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812383|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812384|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812385|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812386|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812387|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812388|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812389|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812390|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812391|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812392|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812393|NCT01352845|O2|Outcome|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812394|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812395|NCT01352845|O1|Outcome|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812396|NCT01352845|E2|Reported Event|Group 2 Saline|Saline on a 0-, 2-, 6- month schedule.
812397|NCT01352845|E1|Reported Event|Group 1 rLP2086|Recombinant lipoprotein 2086 (rLP2086) vaccine on a 0-, 2-, 6- month schedule.
812398|NCT01352793|B3|Baseline|Total|Total of all reporting groups
812399|NCT01352793|B2|Baseline|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812400|NCT01352793|B1|Baseline|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812401|NCT01352793|P2|Participant Flow|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812402|NCT01352793|P1|Participant Flow|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812403|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812404|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812405|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812406|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812407|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812408|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812409|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812410|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812411|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812412|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812413|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812414|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812415|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812416|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812417|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812418|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812419|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812420|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812421|NCT01352793|O2|Outcome|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812422|NCT01352793|O1|Outcome|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812423|NCT01352793|E2|Reported Event|Group 2: HAV/Saline/HAV|Randomized to receive hepatitis A virus (HAV) vaccine (Havrix) on a 0-, 6- month schedule and normal saline on 2-month
812424|NCT01352793|E1|Reported Event|Group 1: rLP2086|Randomized to receive Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine on a 0, 2-, 6-month schedule
812425|NCT01352741|B1|Baseline|All Trial Participants|All participants that received at least one dose of tapentadol prolonged release at baseline, in the open-label titration period.
812426|NCT01352741|P2|Participant Flow|Tapentadol Prolonged Release and Pregabalin|At the end of the Open-label Tapentadol Titration Period participants that qualified were randomized to either tapentadol or tapentadol and pregabalin treatment. In this double-blind period participants started on Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
812427|NCT01352741|P1|Participant Flow|Tapentadol Prolonged Release|All participants entered the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion. Participants that did not qualify for entry into the Comparative Period were able to enter the open-label Continuation Period. During the double-blind comparator phase the dose was increased to 200 mg twice daily and after a week to 250 mg twice daily. Participants that dropped out due to tolerability issues during the comparative period were able to enter the open-label pick-up arm.
812428|NCT01352741|O2|Outcome|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
812429|NCT01352741|O1|Outcome|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
812430|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period.
812431|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812432|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812433|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812434|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812435|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812436|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812437|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812438|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812439|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
812440|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
812441|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
812442|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812443|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812444|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812445|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812446|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
812447|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
812448|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
812449|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812450|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812668|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
812451|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812452|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812453|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
812454|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
812455|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
812456|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812457|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812458|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812459|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812460|NCT01352741|O3|Outcome|Randomization Visit (Day 22)|End of open-label titration period. Participants with 100 to 300 mg/day tapentadol.
812461|NCT01352741|O2|Outcome|Baseline Visit (Day 1)|At the end of the washout period prior to starting 100 mg/day tapentadol prolonged release.
812462|NCT01352741|O1|Outcome|Enrollment Visit (Day -12)|Participant feedback at the Enrollment Visit; on previous analgesic medication prior to study drug start.
812463|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812464|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812465|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812466|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812467|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812468|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812469|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812470|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812471|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812472|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812473|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812474|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812475|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812476|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812658|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
812659|NCT01351090|E3|Reported Event|Placebo Vehicle IN|Intranasal placebo
812477|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812478|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812479|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812480|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812481|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812482|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812483|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812484|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812485|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812486|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812487|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812488|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812489|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812490|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812491|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
812492|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812493|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812494|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812495|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812496|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
812497|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812498|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812499|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812500|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812501|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
812660|NCT01351090|E2|Reported Event|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
812502|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812503|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812504|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812505|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812506|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration
812507|NCT01352741|O2|Outcome|Tapentadol Prolonged Release After Tapentadol and Pregabalin|Participants that dropped-out of the Tapentadol Prolonged Release and Pregabalin in the double-blind Comparative Period continued with Tapentadol Prolonged Release at either 300 or 400 mg per day in this Open-Label Pick-up arm.
812508|NCT01352741|O1|Outcome|Tapentadol Prolonged Release After Tapentadol|Participants that drop-out of the double-blind tapentadol prolonged release treatment in the Comparative Period, due to tolerability issues, continued on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day in this Open-Label Pick-up arm.
812509|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Participants that did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day, if they had reached a satisfactory level of pain relief.
812510|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily. Tapentadol PR was administered in an open-label fashion during the 3-week titration period. All participants started at 2 x 50 mg (100 mg per day) after the baseline visit and titrated upwards on a weekly basis by 2 x 50 mg. Dose adjustment could have taken place after 3 days on a stable dose if the participant's pain required faster titration.
812511|NCT01352741|O2|Outcome|Tapentadol Prolonged Release and Pregabalin|Tapentadol Prolonged Release (100 - 300 mg per day) in the open-label titration period. Subsequently Tapentadol 300 mg per day was combined with Pregabalin at a daily dose of 300 mg per day.
812512|NCT01352741|O1|Outcome|Tapentadol Prolonged Release|Tapentadol PR (100 - 300 mg per day) oral administration twice daily in the open-label titration period. Subsequently increased in the comparative period to Tapentadol Prolonged Release to 500 mg per day.
812513|NCT01352741|E5|Reported Event|Open-Label Tapentadol Continuation Period|Participants who did not qualify for randomization to the Comparator Period, continued on a stable dose of Tapentadol Prolonged Release 300 mg per day if they had reached a satisfactory level of pain relief.
812514|NCT01352741|E4|Reported Event|Open-Label Tapentadol Pick-Up Arm|Participants that drop-out of the Comparative Period, due to tolerability issues, were permitted to continue on Tapentadol Prolonged Release at either 300 mg per day or 400 mg per day.
812515|NCT01352741|E3|Reported Event|Tapentadol and Pregabalin in the Comparative Period|Tapentadol Prolonged Release 300 mg per day (2 x 150 mg) plus Pregabalin 2 x 75 mg (total daily dose of 150 mg). A week later the dose of Pregabalin was increased to a total daily dose of 300 mg per day (2 x 150 mg), the Tapentadol Prolonged Release dose remained at 300 mg per day.
812516|NCT01352741|E2|Reported Event|Tapentadol in the Comparative Period|The dose of Tapentadol Prolonged Release was increased to 400 mg (2 x 200mg) and a week later to 500 mg (2 x 250 mg) per day and maintained at 500 mg per day.
812517|NCT01352741|E1|Reported Event|Open-Label Tapentadol Titration Period|"During the 3-week Titration Period, Tapentadol Prolonged Release was administered in an open-label fashion.~Titration dose steps on a weekly basis:~First 50 mg administered twice daily, then 100 mg administered twice daily and then 150 mg administered twice daily.~The titration period could be shortened to 10 days, with a participant at a predefined dose level for at least 3 days.~The dose of 300 mg Tapentadol per day was maintained until the Randomization Visit."
812518|NCT01352715|B3|Baseline|Total|Total of all reporting groups
812519|NCT01352715|B2|Baseline|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812520|NCT01352715|B1|Baseline|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812521|NCT01352715|P2|Participant Flow|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812522|NCT01352715|P1|Participant Flow|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812556|NCT01352507|B1|Baseline|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
812669|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
812523|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812524|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812525|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812526|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812527|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812528|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812529|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812530|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812531|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812532|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812533|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812534|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812614|NCT01351506|B3|Baseline|Total|Total of all reporting groups
812615|NCT01351506|B2|Baseline|ICU Non Survivors|Patients who non survivors from ICU discharge status
812535|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812536|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812537|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812538|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812539|NCT01352715|O2|Outcome|Arm B: LPV/r Plus Best Available NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily.~Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812540|NCT01352715|O1|Outcome|Arm A: LPV/r Plus RAL|"Participants were administered LPV/r plus RAL orally twice daily.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily.~Raltegravir: Raltegravir 400 mg tablet orally twice daily."
812541|NCT01352715|E2|Reported Event|LPV/r + NRTIs|"Participants were administered LPV/r orally twice daily, plus NRTI options provided by the study, to include the best available NRTIs.~Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Emtricitabine/tenofovir disoproxil fumarate: Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily.~Abacavir/lamivudine/zidovudine: Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir/lamivudine: Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily.~Lamivudine/zidovudine: Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily.~Abacavir: Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily.~Zidovudine: Zidovudine 300 mg tablet orally twice daily. Lamivudine: Lamivudine 150 mg tablet orally twice daily."
812542|NCT01352715|E1|Reported Event|LPV/r + RAL|Participants were administered LPV/r plus RAL orally twice daily. Lopinavir/ritonavir: Lopinavir 400mg/ritonavir 100mg orally twice daily. Raltegravir: Raltegravir 400 mg tablet orally twice daily.
812543|NCT01352585|B1|Baseline|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812544|NCT01352585|P1|Participant Flow|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812545|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812546|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812547|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812548|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812549|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812550|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812551|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812552|NCT01352585|O1|Outcome|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812553|NCT01352585|E1|Reported Event|Anagrelide Hydrochloride|Anagrelide hydrochloride: 0.5 mg hard capsules, dosing decisions will be made by the treating physician
812554|NCT01352507|B3|Baseline|Total|Total of all reporting groups
812555|NCT01352507|B2|Baseline|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
812661|NCT01351090|E1|Reported Event|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
812662|NCT01351064|B3|Baseline|Total|Total of all reporting groups
812557|NCT01352507|P2|Participant Flow|Sildenafil Then Tadalafil|"100 mg sildenafil taken orally, as needed, for 8 weeks, followed by 20 mg tadalafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for ED."
812558|NCT01352507|P1|Participant Flow|Tadalafil Then Sildenafil|"20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks, followed by 100 mg sildenafil taken orally, as needed, for an additional 8 weeks. There was a washout period of 7 to 10 days between treatments.~At the end of the two 8-week treatment periods, participants were allowed to enter an 8-week extension phase on their preferred medication for erectile dysfunction (ED)."
812559|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812560|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812561|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812562|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812563|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812564|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812565|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812566|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812567|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812568|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812569|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812570|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812571|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812572|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812573|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
812574|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
812575|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812576|NCT01352507|O1|Outcome|Tadalafil|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812577|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812578|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812579|NCT01352507|O2|Outcome|Sildenafil|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812580|NCT01352507|O1|Outcome|Tadalafil|20 milligrams (mg) tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812581|NCT01352507|O2|Outcome|Sildenafil|Participants who preferred sildenafil over tadalafil.
812582|NCT01352507|O1|Outcome|Tadalafil|Participants who preferred tadalafil over sildenafil.
812583|NCT01352507|O1|Outcome|All Randomized Participants|Includes participants randomized to initially receive tadalafil (20 mg taken orally, as needed, for 8 weeks) and participants randomized to initially receive sildenafil (100 mg taken orally, as needed, for 8 weeks).
812584|NCT01352507|E4|Reported Event|Sildenafil (Extension Phase)|Participants who preferred sildenafil over tadalafil received 100 mg sildenafil taken orally, as needed, for an additional 8 weeks.
812585|NCT01352507|E3|Reported Event|Tadalafil (Extension Phase)|Participants who preferred tadalafil over sildenafil received 20 mg tadalafil taken orally, as needed, for an additional 8 weeks.
812586|NCT01352507|E2|Reported Event|Sildenafil (Treatment Periods)|100 mg sildenafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812587|NCT01352507|E1|Reported Event|Tadalafil (Treatment Periods)|20 mg tadalafil taken orally, as needed, for 8 weeks either during Treatment Period 1 or Treatment Period 2.
812588|NCT01352442|B1|Baseline|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
812589|NCT01352442|P1|Participant Flow|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
812590|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
812591|NCT01352442|O1|Outcome|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
812592|NCT01352442|E1|Reported Event|AcuFocus Corneal Inlay|"The AcuFocus Corneal Inlay ACI 7000PDT, which is a small medical device, will be surgically implanted in one eye of each subject.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
812594|NCT01352416|B4|Baseline|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812595|NCT01352416|B3|Baseline|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812596|NCT01352416|B2|Baseline|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812597|NCT01352416|B1|Baseline|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812598|NCT01352416|P4|Participant Flow|Sugar Pills and Patients Having Non CABG Heart Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
812599|NCT01352416|P3|Participant Flow|Ranolazine With Patients Having Non CABG Heart Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812600|NCT01352416|P2|Participant Flow|Sugar Pill and Patients Having CABG Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects, or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 1 pill twice daily.~Atrial fibrillation : Once the patient goes into atrial fibrillation, the study drug is still continued. Patient will also be treated with standard drug therapy that their doctor chooses"
812601|NCT01352416|P1|Participant Flow|Ranolazine and Patients Having CABG Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812602|NCT01352416|O4|Outcome|Placebo Without CABG|Placebo 2 pills twice daily without CABG
812603|NCT01352416|O3|Outcome|Ranolazine Without CABG|Ranolazine 500 mg 2 pills twice daily without CABG
812604|NCT01352416|O2|Outcome|Placebo With CABG|Placebo 2 pills twice daily with CABG
812605|NCT01352416|O1|Outcome|Ranolazine With Coronary Artery Bypass Graft (CABG)|Ranolazine 500 mg 2 pills twice a day with Coronary Artery Bypass Graft (CABG)
812606|NCT01352416|E4|Reported Event|Placebo Pill and Patients Having Non Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812607|NCT01352416|E3|Reported Event|Ranolazine and Patients Having Non Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812608|NCT01352416|E2|Reported Event|Placebo Pill and Patients Having Heart Bypass Surgery|"2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812609|NCT01352416|E1|Reported Event|Ranolazine and Patients Having Heart Bypass Surgery|"500 mg tab, 2 pills twice a day. If intolerant to the study drug due to adverse effects,or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500 mg, 1 pill twice daily.~Atrial fibrillation : Once patient is in atrial fibrillation, the study drug is still continued. Patients will also be treated with standard drug therapy that their doctor chooses"
812610|NCT01351623|B1|Baseline|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
812611|NCT01351623|P1|Participant Flow|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
812612|NCT01351623|O1|Outcome|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
812613|NCT01351623|E1|Reported Event|Carfilzomib|"A single arm, open-label, single institution phase 2 clinical trial is planned.~Carfilzomib: Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle."
812617|NCT01351506|P1|Participant Flow|Cohort Patient|A total of 602 patients as inclusion criteria between May 2011 and August 2012 were enrolled on the ICU admission (day 0). One hundred thirty seven patients were excluded due to a short stay in ICU or were not weighed a second time on day 1. The remainder of 465 patients were included and followed in this study.
812618|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
812619|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
812620|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
812621|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
812622|NCT01351506|O2|Outcome|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
812623|NCT01351506|O1|Outcome|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
812624|NCT01351506|E2|Reported Event|> 5%|Maximum weight change upto 7 days more than 5% of admission weight
812625|NCT01351506|E1|Reported Event|</= 5%|Maximum weight change upto 7 days less than or equal to 5% of admission body weight
812626|NCT01351480|B1|Baseline|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812627|NCT01351480|P1|Participant Flow|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812628|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812629|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812630|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812631|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812632|NCT01351480|O1|Outcome|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812633|NCT01351480|E1|Reported Event|Abatacept|"open label use of abatacept for 12 months~abatacept: Abatacept administered SC weekly at 125 mg dose"
812634|NCT01351337|B1|Baseline|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
812635|NCT01351337|P1|Participant Flow|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
812636|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring and diffusion tensor tractography~All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
812637|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
812638|NCT01351337|O1|Outcome|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
812639|NCT01351337|E1|Reported Event|Intraoperative Functional Monitoring|"intraoperative functional monitoring~diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation: All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation"
812640|NCT01351090|B4|Baseline|Total|Total of all reporting groups
812641|NCT01351090|B3|Baseline|Placebo Vehicle IN|Intranasal placebo
812642|NCT01351090|B2|Baseline|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
812643|NCT01351090|B1|Baseline|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
812644|NCT01351090|P3|Participant Flow|Placebo Vehicle IN|Intranasal placebo
812645|NCT01351090|P2|Participant Flow|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
812646|NCT01351090|P1|Participant Flow|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
812647|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
812648|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
812649|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
812650|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
812651|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
812652|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
812653|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
812654|NCT01351090|O2|Outcome|Ketorolac IN 30 mg|30 mg Intranasal (2 x 100 uL of a 15% solution)
812655|NCT01351090|O1|Outcome|Ketorolac IN 10 mg|10 mg Intranasal (2 x 100 uL of a 5% solution)
812656|NCT01351090|O3|Outcome|Placebo Vehicle IN|Intranasal placebo
812664|NCT01351064|B1|Baseline|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
812665|NCT01351064|P2|Participant Flow|CHICA ADHD Control|This arm received CHICA without the ADHD module
812666|NCT01351064|P1|Participant Flow|CHICA ADHD Module|"This arm received The Child Health Improvement through Computer Automation (CHICA) Attention Deficit Hyperactivity Disorder (ADHD) Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
812667|NCT01351064|O2|Outcome|CHICA ADHD Control|This arm received CHICA without the ADHD module
812670|NCT01351064|O1|Outcome|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
812671|NCT01351064|E2|Reported Event|CHICA ADHD Control|This arm received CHICA without the ADHD module
812672|NCT01351064|E1|Reported Event|CHICA ADHD Module|"This arm received The CHICA ADHD Module~CHICA ADHD Module: This module was added to CHICA to help diagnose and manage ADHD"
812673|NCT01351025|B3|Baseline|Total|Total of all reporting groups
812674|NCT01351025|B2|Baseline|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812675|NCT01351025|B1|Baseline|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812676|NCT01351025|P2|Participant Flow|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812677|NCT01351025|P1|Participant Flow|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812678|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812679|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
812680|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
812681|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812737|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812738|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812739|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812740|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812741|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812682|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812749|NCT01350973|B1|Baseline|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
813077|NCT01350115|P1|Participant Flow|LDE225|Participants received 400 mg once daily.
812683|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812684|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812685|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812686|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812687|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812688|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812689|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812690|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812691|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812692|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812693|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812694|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812695|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812696|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812697|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812698|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812699|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812700|NCT01351025|O2|Outcome|Arm B: Placebo / Atorvastatin|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.~At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.~atorvastatin: Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44."
812701|NCT01351025|O1|Outcome|Arm A: Atorvastatin / Placebo|"At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.~At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.~atorvastatin: 10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4 - week 20"
812702|NCT01351025|E4|Reported Event|Arm B: Placebo / Atorvastatin After Cross-over (Week 24 - 48)|At week 24, atorvastatin was started at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at week 28. At week 44, atorvastatin was stopped to allow for another 4-week washout period.
812703|NCT01351025|E3|Reported Event|Arm A: Atorvastatin / Placebo After Cross-over (Week 24 - 48)|At week 24, placebo was started for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the placebo dose was doubled at week 28. At week 44, the placebo was stopped to allow for another 4-week washout period.
812704|NCT01351025|E2|Reported Event|Arm B: Placebo / Atorvastatin Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated placebo for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, the dose of placebo was doubled at the week 4 visit. At week 20, the placebo was stopped for a 4-week washout period.
812705|NCT01351025|E1|Reported Event|Arm A: Atorvastatin / Placebo Before Cross-over (Week 0 - 24)|At study entry (week 0), participants continued the entry boosted PI-based antiretroviral regimen (not provided by the study) and initiated atorvastatin at a daily dose of 10 mg for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, the dose of atorvastatin was increased to 20 mg daily at the week 4 visit. At week 20, atorvastatin was stopped for a 4-week washout period.
812706|NCT01350999|B4|Baseline|Total|Total of all reporting groups
812707|NCT01350999|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812708|NCT01350999|B2|Baseline|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812709|NCT01350999|B1|Baseline|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812710|NCT01350999|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812711|NCT01350999|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812712|NCT01350999|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812713|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812714|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812715|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812716|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812717|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812718|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812719|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812720|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812721|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812722|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812723|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812724|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812725|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812726|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812727|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812728|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812729|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812730|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812731|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812732|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812733|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812734|NCT01350999|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812735|NCT01350999|O2|Outcome|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812736|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812742|NCT01350999|O1|Outcome|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812743|NCT01350999|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 52 weeks.
812744|NCT01350999|E2|Reported Event|TAK-085 4 g|TAK-085 2 g capsules, orally, twice daily for up to 52 weeks.
812745|NCT01350999|E1|Reported Event|TAK-085 2 g|TAK-085 2 g capsule, orally, once daily for up to 52 weeks.
812746|NCT01350973|B4|Baseline|Total|Total of all reporting groups
812747|NCT01350973|B3|Baseline|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812748|NCT01350973|B2|Baseline|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812750|NCT01350973|P3|Participant Flow|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812751|NCT01350973|P2|Participant Flow|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812752|NCT01350973|P1|Participant Flow|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812753|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812754|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812755|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812756|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812757|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812758|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812759|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812760|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812761|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812762|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812763|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812764|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812765|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812766|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812767|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812768|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812769|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812770|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812771|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812772|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812773|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812774|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812775|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812776|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812777|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812778|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812779|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812780|NCT01350973|O3|Outcome|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812781|NCT01350973|O2|Outcome|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812782|NCT01350973|O1|Outcome|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812783|NCT01350973|E3|Reported Event|EPA-E 1.8 g|Eicosapentaenoic acid-ethyl (EPA-E) capsule 0.6 g, orally, three-times daily for up to 12 weeks.
812784|NCT01350973|E2|Reported Event|TAK-085 4 g|TAK-085 2 g, orally, twice daily for up to 12 weeks.
812785|NCT01350973|E1|Reported Event|TAK-085 2 g|TAK-085 2 g, orally, once daily for up to 12 weeks.
812786|NCT01350947|B1|Baseline|All Patients|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
812787|NCT01350947|P1|Participant Flow|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
812788|NCT01350947|O1|Outcome|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
812820|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
812961|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
812789|NCT01350947|E1|Reported Event|Arm 1 - 5-Azacitidine|"All participants enrolled.~5-Azacitidine: Administered on Days 1-7 of each Cycle.~Subcutaneous administration:~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.~The 5-azacitidine suspension is administered subcutaneously.~Intravenous Administration:~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
812790|NCT01350934|B3|Baseline|Total|Total of all reporting groups
812791|NCT01350934|B2|Baseline|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812792|NCT01350934|B1|Baseline|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812793|NCT01350934|P2|Participant Flow|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812794|NCT01350934|P1|Participant Flow|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812795|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812796|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812797|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812798|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812799|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812800|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812801|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812802|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812803|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812804|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812805|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812806|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812807|NCT01350934|O2|Outcome|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812808|NCT01350934|O1|Outcome|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812809|NCT01350934|E2|Reported Event|Calcitriol|Participants received calcitriol 0.25 μg once daily orally for 6 months (base study), and then once daily orally for another 6 months (extension study).
812810|NCT01350934|E1|Reported Event|Fosamax Plus|Participants received alendronate 70 mg plus vitamin D3 5600 IU in a combination tablet (FOSAMAX PLUS D) once weekly for 6 months (base study), and then once weekly for another 6 months (extension study).
812811|NCT01350804|B5|Baseline|Total|Total of all reporting groups
812812|NCT01350804|B4|Baseline|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812813|NCT01350804|B3|Baseline|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812814|NCT01350804|B2|Baseline|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812815|NCT01350804|B1|Baseline|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812816|NCT01350804|P4|Participant Flow|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812817|NCT01350804|P3|Participant Flow|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812818|NCT01350804|P2|Participant Flow|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812819|NCT01350804|P1|Participant Flow|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812821|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812822|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
812823|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
812824|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812825|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
812826|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
812827|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812828|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812829|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812830|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812831|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
812832|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812833|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
812834|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
812835|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812836|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
812837|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
812838|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812839|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812840|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812841|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812842|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
812843|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812844|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
812845|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
812846|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812847|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
812848|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
812849|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812850|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812851|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812852|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812853|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812854|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812855|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812856|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812857|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
812858|NCT01350804|O10|Outcome|Abatacept Non-responders - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812953|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
812859|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
812860|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
812861|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812862|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
812863|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
812962|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
813175|NCT01349829|B3|Baseline|Total|Total of all reporting groups
812864|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812865|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812866|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812867|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812868|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812869|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812870|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812871|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812872|NCT01350804|O11|Outcome|Abatacept Non-responders - AIN457 150mg|Participants switched from abatacept to AIN457 150 mg starting at week 24.
812873|NCT01350804|O10|Outcome|Abatacept Non-respnders - AIN457 75mg|Participants switched from abatacept to AIN457 75 mg starting at week 24.
812874|NCT01350804|O9|Outcome|Abatacept Responders|Abatacept responders remained on abatacept (from 500 to 1000 mg iv based on weight).
812875|NCT01350804|O8|Outcome|Placebo Responder - AIN457 150mg|Participants switched from placebo to AIN457 150 mg starting at week 24.
812876|NCT01350804|O7|Outcome|Placebo Responder - AIN457 75mg|Participants switched from placebo to AIN457 75 mg starting at week 24.
812877|NCT01350804|O6|Outcome|Placebo Non-responder - AIN457 150 mg|Participants switched from placebo to AIN457 150 mg starting at week 16.
812878|NCT01350804|O5|Outcome|Placebo Non-responder - AIN457 75 mg|Participants switched from placebo to AIN457 75 mg starting at week 16.
812879|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812880|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812881|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812882|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812883|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812884|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812885|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812886|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812887|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812888|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812889|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812890|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812891|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812892|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
813046|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
812893|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812894|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812895|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
813176|NCT01349829|B2|Baseline|Havrix|
812896|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812897|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812898|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812899|NCT01350804|O4|Outcome|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812900|NCT01350804|O3|Outcome|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812901|NCT01350804|O2|Outcome|AIN457 10mg/kg - 150 mg|Participants received AIN457 i.v. (10 mg/kg) at BSL, Weeks 2 and 4 then AIN457 150 mg s.c. at Week 8 and injected every 4 weeks.
812902|NCT01350804|O1|Outcome|AIN457 10mg/kg - 75 mg|Participants received AIN457 i.v. (10 mg/kg) at Baseline (BSL), Weeks 2 and 4 then AIN457 75 mg s.c. at Week 8 and injected every 4 weeks.
812903|NCT01350804|E4|Reported Event|Abatacept|Participants received abatacept (from 500 to 1000 mg i.v. based on weight). Participants who did not respond to abatacept at Week 16 were re-randomized 1:1 to AIN457 75mg or 150mg at week 24 (after an 8 week washout period).
812904|NCT01350804|E3|Reported Event|Placebo|Participants received matching placebo to AIN457 until week 16 or week 24 based on responder status (>= 20% reduction in tender and swollen joint count). Non-responders were switched to active treatment at week 16. Responders were switched to active treatment at week 24.
812905|NCT01350804|E2|Reported Event|Any AIN457 150 mg|Any AIN457 150 mg
812906|NCT01350804|E1|Reported Event|Any AIN457 75 mg|Any AIN457 75 mg
812907|NCT01350583|B1|Baseline|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
812908|NCT01350583|P1|Participant Flow|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
812909|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
812910|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
812911|NCT01350583|O1|Outcome|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
812912|NCT01350583|E1|Reported Event|Sodium Bicarbonate Therapy|"Dose Escalation~Sodium Bicarbonate (NaHCO3) : Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated."
812913|NCT01350544|B3|Baseline|Total|Total of all reporting groups
812914|NCT01350544|B2|Baseline|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
812915|NCT01350544|B1|Baseline|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
812916|NCT01350544|P2|Participant Flow|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
812917|NCT01350544|P1|Participant Flow|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
812954|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
812963|NCT01350388|O2|Outcome|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
812964|NCT01350388|O1|Outcome|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
812965|NCT01350388|E2|Reported Event|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
812966|NCT01350388|E1|Reported Event|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
812967|NCT01350271|B4|Baseline|Total|Total of all reporting groups
812968|NCT01350271|B3|Baseline|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
813177|NCT01349829|B1|Baseline|HAVpur|
812918|NCT01350544|O2|Outcome|Treatment Advocacy|Treatment Advocacy: Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary. This description is subject to change after consideration by the community advisory board.
812919|NCT01350544|O1|Outcome|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
812920|NCT01350544|E2|Reported Event|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
812921|NCT01350544|E1|Reported Event|Wait-list Control|Participants in the wait-list control group will not receive the intervention until after the 6-month follow-up assessment.
812922|NCT01350479|B3|Baseline|Total|Total of all reporting groups
812923|NCT01350479|B2|Baseline|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
812924|NCT01350479|B1|Baseline|MRSA Colonized|Residents colonized with MRSA by culture at study admission
812925|NCT01350479|P2|Participant Flow|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
812926|NCT01350479|P1|Participant Flow|MRSA Colonized|Residents colonized with MRSA by culture at study admission
812927|NCT01350479|O2|Outcome|Swabs From Interactions With Not MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents not colonized with MRSA by culture on enrollment
812928|NCT01350479|O1|Outcome|Swabs From Interactions With MRSA Colonized Residents|Swabs collected from healthcare workers interacting with residents colonized with MRSA by culture on enrollment
812929|NCT01350479|E2|Reported Event|Not MRSA Colonized|Residents not colonized with MRSA by culture at study admission
812930|NCT01350479|E1|Reported Event|MRSA Colonized|Residents colonized with MRSA by culture at study admission
812931|NCT01350414|B1|Baseline|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02, NCT00231114).
812932|NCT01350414|P1|Participant Flow|Alair Group|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02)~Bronchial Thermoplasty with the Alair System: Bronchial Thermoplasty with the Alair System"
812933|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol Number 04-02, NCT00231114).
812934|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
812935|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
812936|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
812937|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
812938|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
812939|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
812940|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).
812941|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
812942|NCT01350414|O1|Outcome|Alair Group|Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol number 04-02, NCT00231114).
812943|NCT01350414|E5|Reported Event|Year 5|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 5 is defined as 1461 days to 1826 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 5 annual visit or not."
812944|NCT01350414|E4|Reported Event|Year 4|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 4 is defined as 1096 to 1460 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 4 annual visit or not."
812945|NCT01350414|E3|Reported Event|Year 3|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 3 is defined as 731 to 1095 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 3 annual visit or not."
812946|NCT01350414|E2|Reported Event|Year 2|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 2 is defined as 366 to 730 days after the treatment period. All subjects were considered in the analysis regardless of whether they have completed the Year 2 annual visit or not."
812947|NCT01350414|E1|Reported Event|Year 1|"Subjects who underwent treatment with the Alair System in the AIR2 Trial (Protocol No. 04-02).~Year 1 is defined as 365 days from the treatment period (6 weeks after the last bronchoscopy). All subjects were considered in the analysis regardless of whether they have completed the Year 1 annual visit or not."
812948|NCT01350388|B3|Baseline|Total|Total of all reporting groups
812949|NCT01350388|B2|Baseline|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
812950|NCT01350388|B1|Baseline|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
812951|NCT01350388|P2|Participant Flow|Placebo|Placebo: 1 placebo tablet per day for 24 weeks
812952|NCT01350388|P1|Participant Flow|Febuxostat|Febuxostat: 80 mg/day of febuxostat for 24 weeks
812969|NCT01350271|B2|Baseline|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
812970|NCT01350271|B1|Baseline|Placebo|Hookworm positive participants randomized to placebo
812971|NCT01350271|P3|Participant Flow|Mebendazole Polymorph C 500 mg|74 were allocated and 48 were followed up in the post treatment.
812972|NCT01350271|P2|Participant Flow|Mebendazole Polymorph A and C 500 mg|70 were allocated and 53 were followed up in the post treatment.
812973|NCT01350271|P1|Participant Flow|Placebo|70 were allocated to this arm and 49 were followed up in the post treatment.
812974|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
812975|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
812976|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
812977|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose Mebendazole polymorph C 500 mg
812978|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
812979|NCT01350271|O1|Outcome|Placebo|Hookworm positive participants randomized to placebo
812980|NCT01350271|O3|Outcome|Mebendazole Polymorph C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph C 500 mg
812981|NCT01350271|O2|Outcome|Mebendazole Polymorph A and C 500 mg|Hookworm infected individuals randomized to a single dose of Mebendazole polymorph A and C 500 mg
812982|NCT01350271|O1|Outcome|Placebo|Hookworm infected individual randomized to placebo
812983|NCT01350271|E3|Reported Event|Mebendazole Polymorph C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph C 500 mg
812984|NCT01350271|E2|Reported Event|Mebendazole Polymorph A and C 500 mg|Hookworm positive participants randomized to a single dose of Mebendazole polymorph A and C 500 mg
812985|NCT01350271|E1|Reported Event|Placebo|Hookworm positive participants randomized to placebo
812986|NCT01350258|B1|Baseline|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
812987|NCT01350258|P1|Participant Flow|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
812988|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
812989|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
812990|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
812991|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
813047|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813048|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813049|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813050|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813051|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
812992|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
813068|NCT01350128|E5|Reported Event|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
812993|NCT01350258|O1|Outcome|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
812994|NCT01350258|E1|Reported Event|Transplant Treatment Group|"REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and thiotepa IV (cytarabine IV as of February 2012) over 2 hours on days -11 to -9. Patients undergo TBI on day -6. Patients receive melphalan IV over 20 minutes on days -3 and -2.~TRANSPLANTATION: Patients undergo DLI on day -6 and allogeneic CD-34+ peripheral blood stem cell transplantation on day 0.~GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and receive MMF IV BID on days -1 to day 28."
812995|NCT01350245|B1|Baseline|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
812996|NCT01350245|P1|Participant Flow|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
812997|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
812998|NCT01350245|O1|Outcome|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
812999|NCT01350245|E1|Reported Event|TJU 2 Step Regimen|"All patients treated on this trial will have hematological malignancies that are in remission at the time of the transplant. Their diseases would be expected to relapse with standard therapy alone.~Total Body Irradiation (TBI): Total body irradiation given in 8 fractions over 4 days (total dose of 12 Gy).~Donor Lymphocyte Infusion (DLI): After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.~Cyclophosphamide: Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days~Mycophenolate Mofetil (MMF): Started the day before the transplant to prevent graft versus host disease (GVHD)~Tacrolimus: Started the day before the transplant to prevent graft-versus-host disease (GVHD)~Hematopoietic stem cell transplantation (HSCT): One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-do"
813052|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813053|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813054|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813055|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813056|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813057|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813058|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813059|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813069|NCT01350128|E4|Reported Event|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813070|NCT01350128|E3|Reported Event|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813071|NCT01350128|E2|Reported Event|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813072|NCT01350128|E1|Reported Event|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813073|NCT01350115|B3|Baseline|Total|Total of all reporting groups
813074|NCT01350115|B2|Baseline|Placebo|Participants received matching placebo.
813000|NCT01350232|B1|Baseline|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813001|NCT01350232|P1|Participant Flow|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813002|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813003|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813004|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813005|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813006|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813060|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813061|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813062|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813063|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813064|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813065|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813066|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813007|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813008|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813009|NCT01350232|O1|Outcome|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813010|NCT01350232|E1|Reported Event|HSCT|"Subjects receive the preparative regimen in 2 steps. The first step will be with fludarabine and cytarabine and a low dose of total body irradiation. This will be followed by the first step of the transplant graft - the donor lymphocytes. The second step of the chemotherapy will be two doses of cyclophosphamide. This will then be followed by the second step of the transplant graft - the stem cells.~Only subjects with prior alloimmunization against donor will receive desensitization. Subjects who demonstrate alloimmunization against the HLA of the donor will receive bortezomib and rituximab in combination with plasmapheresis prior to the admission for transplant.~Fludarabine: Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen~Cytarabine: Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine~Cellular Infusions: Subjects will receive the cellular"
813011|NCT01350128|B1|Baseline|ITT Population|ITT Population includes all subjects who were randomized, received at least 1 dose of study treatment, and had both baseline and post-baseline efficacy data for that treatment.
813012|NCT01350128|P1|Participant Flow|All Subjects Randomized|
813013|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813014|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813015|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813016|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813017|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813018|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813019|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813020|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813021|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813022|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813023|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813024|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813025|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813026|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813027|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813028|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813029|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813030|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813031|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813032|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813033|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813034|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813035|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813036|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813037|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813038|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813039|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813040|NCT01350128|O3|Outcome|PT001 MDI 9 µg BID|PT001 MDI 9 µg BID
813041|NCT01350128|O2|Outcome|PT001 MDI 18 µg BID|PT001 MDI 18 µg BID.
813042|NCT01350128|O1|Outcome|PT001 MDI 36 µg BID|PT001 MDI 36 µg BID.
813043|NCT01350128|O6|Outcome|Placebo MDI BID|Placebo MDI BID.
813044|NCT01350128|O5|Outcome|Ipratropium Bromide HFA Inhalation Aerosol|Ipratropium Bromide HFA Inhalation Aerosol 34 µg QID.
813045|NCT01350128|O4|Outcome|PT001 MDI 4.6 µg BID|PT001 MDI 4.6 µg BID.
813078|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
813079|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
813080|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
813081|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
813082|NCT01350115|O2|Outcome|Placebo|Participants received matching placebo.
813083|NCT01350115|O1|Outcome|LDE225|Participants received 400 mg once daily.
813084|NCT01350115|E4|Reported Event|Placebo - Long Term Follow-up|
813085|NCT01350115|E3|Reported Event|LDE225 - Long Term Follow-up|
813086|NCT01350115|E2|Reported Event|Placebo - Core|Participants received matching placebo.
813087|NCT01350115|E1|Reported Event|LDE225 - Core|Participants received 400 mg once daily.
813088|NCT01349972|B3|Baseline|Total|Total of all reporting groups
813089|NCT01349972|B2|Baseline|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813090|NCT01349972|B1|Baseline|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813091|NCT01349972|P2|Participant Flow|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813092|NCT01349972|P1|Participant Flow|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813093|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813094|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813095|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813096|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813097|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813098|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813099|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813116|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
813100|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813101|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813178|NCT01349829|P2|Participant Flow|Havrix|
813179|NCT01349829|P1|Participant Flow|HAVpur|
813102|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813103|NCT01349972|O2|Outcome|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813104|NCT01349972|O1|Outcome|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813105|NCT01349972|E2|Reported Event|Arm II (Cytarabine, Daunorubicin Hydrochloride)|"Patients receive cytarabine IV continuously on days 1-7 and daunorubicin hydrochloride IV on days 1-3. Patients who have residual disease on day 14 may receive additional cytarabine for 5 days and daunorubicin hydrochloride for 2 days.~daunorubicin hydrochloride: Given IV~cytarabine: Given IV"
813106|NCT01349972|E1|Reported Event|Arm I (Alvocidib, Cytarabine, Mitoxantrone Hydrochloride)|"Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 1-2 hours on day 9. Patients who achieve complete or partial response to the first course (completion of all doses) may receive a second course of treatment or high-dose cytarabine after 21-63 days following blood count recovery, and/or undergo allogeneic bone marrow transplant.~alvocidib: Given IV~mitoxantrone hydrochloride: Given IV~cytarabine: Given IV"
813107|NCT01349959|B1|Baseline|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
813108|NCT01349959|P1|Participant Flow|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
813109|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
813110|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
813111|NCT01349959|O1|Outcome|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
813112|NCT01349959|E1|Reported Event|Treatment (Entinostat and Azacitidine)|"Patients receive azacitidine SC on days 1-5 and 8-10, and entinostat PO on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may continue azacitidine and entinostat in combination with hormonal therapy, at treating physician discretion, or undergo event monitoring.~Azacitidine: Given SC~Entinostat: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
813113|NCT01349933|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
813114|NCT01349933|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
813115|NCT01349933|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200 mg Akt inhibitor MK2206 PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt inhibitor MK2206: Given PO"
813117|NCT01349933|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206: Given PO
813118|NCT01349920|B1|Baseline|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813119|NCT01349920|P1|Participant Flow|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813120|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813121|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813122|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813123|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813124|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813125|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813126|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813127|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813128|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813129|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813130|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813131|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813132|NCT01349920|O1|Outcome|Infliximab 5 mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813133|NCT01349920|E3|Reported Event|Post-study|From last dose of study drug, up to 24 days after last dose of infliximab
813134|NCT01349920|E2|Reported Event|Infliximab 5mg/kg|Infliximab administered intravenously at a dose of 5 mg/kg at study weeks 0, 2, 6, 14, and 22
813135|NCT01349920|E1|Reported Event|Pre-study|From 4 weeks prior to first dose, up to first dose of infliximab
813136|NCT01349907|B3|Baseline|Total|Total of all reporting groups
813137|NCT01349907|B2|Baseline|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813138|NCT01349907|B1|Baseline|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813139|NCT01349907|P2|Participant Flow|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813140|NCT01349907|P1|Participant Flow|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg twice daily (BID), then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813141|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813142|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813143|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813144|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813145|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813146|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813147|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813148|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813149|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813252|NCT01349816|E6|Reported Event|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813150|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813151|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813152|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813153|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813154|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813155|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813156|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813157|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813158|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813159|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813160|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813161|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813162|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813163|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813164|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813165|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813166|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813167|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813168|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813169|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813170|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813171|NCT01349907|O2|Outcome|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813253|NCT01349816|E5|Reported Event|GP MDI 36 µg|GP MDI 36 µg BID
813254|NCT01349816|E4|Reported Event|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813172|NCT01349907|O1|Outcome|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813173|NCT01349907|E2|Reported Event|Placebo/Asenapine|Participants treated with placebo in base trial P06107, were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813174|NCT01349907|E1|Reported Event|Asenapine/Asenapine|Participants treated with asenapine in base trial P06107 were first treated with open-label flavored asenapine 2.5 mg BID, then up-titrated to 5 mg BID at day 4, then up-titrated to 10 mg BID at Day 7. After Day 7, flexible dosing of asenapine was continued for up to 50 weeks.
813196|NCT01349816|B1|Baseline|Overall Study|All patients randomized and treated
813197|NCT01349816|P1|Participant Flow|Overall Study|Overall Study
813198|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813199|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813200|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813201|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813202|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813203|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813204|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813205|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813206|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813207|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813208|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813209|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813210|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813211|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813212|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813213|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813214|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813215|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813216|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813217|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813218|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813219|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813220|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813221|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813222|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813223|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813224|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813225|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813226|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813227|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813228|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813229|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813230|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813231|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813232|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813233|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813234|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813235|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813236|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813237|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813238|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813239|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813240|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813241|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813242|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813243|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813244|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813245|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813246|NCT01349816|O6|Outcome|FF MDI 9.6 µg|FF MDI 9.6 µg BID
813247|NCT01349816|O5|Outcome|GP MDI 36 µg|GP MDI 36 µg BID
813248|NCT01349816|O4|Outcome|GFF MDI 9/9.6 µg|GFF MDI 9/9.6 µg BID
813249|NCT01349816|O3|Outcome|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813250|NCT01349816|O2|Outcome|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813251|NCT01349816|O1|Outcome|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813255|NCT01349816|E3|Reported Event|GFF MDI 18/9.6 µg|GFF MDI 18/9.6 µg BID
813256|NCT01349816|E2|Reported Event|GFF MDI 36/9.6 µg|GFF MDI 36/9.6 µg BID
813257|NCT01349816|E1|Reported Event|GFF MDI 36/7.2 µg|GFF MDI 36/7.2 µg BID
813258|NCT01349803|B5|Baseline|Total|Total of all reporting groups
813259|NCT01349803|B4|Baseline|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
813260|NCT01349803|B3|Baseline|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
813261|NCT01349803|B2|Baseline|GP MDI (PT001)|GP MDI 36 mcg
813262|NCT01349803|B1|Baseline|FF MDI (PT005)|FF MDI 9.6 mcg
813263|NCT01349803|P4|Participant Flow|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
813264|NCT01349803|P3|Participant Flow|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
813265|NCT01349803|P2|Participant Flow|GP MDI (PT001)|GP MDI 36 mcg
813266|NCT01349803|P1|Participant Flow|FF MDI (PT005)|FF MDI 9.6 mcg
813267|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
813268|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
813269|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
813270|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
813271|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813272|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813273|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813274|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813275|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813276|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813277|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813278|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813279|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813280|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813281|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813282|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813283|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813284|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813285|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813286|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813287|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813288|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813289|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813290|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813291|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813292|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813293|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813294|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813295|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813296|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813297|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813298|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813299|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813300|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813301|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813302|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813303|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813304|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813305|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813306|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813307|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813308|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813309|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813310|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59
813311|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813312|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=55 Day 14: N=55
813313|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=57 Day 14: N=57
813314|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=58
813315|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55
813316|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55
813317|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg Day 1: N=58 Day 14: N=57
813318|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg Day 1: N=59 Day 14: N=59
813319|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
813320|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
813321|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
813322|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
813323|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
813324|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
813325|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
813326|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
813327|NCT01349803|O4|Outcome|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
813328|NCT01349803|O3|Outcome|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
813329|NCT01349803|O2|Outcome|GP MDI (PT001)|GP MDI 36 mcg
813330|NCT01349803|O1|Outcome|FF MDI (PT005)|FF MDI 9.6 mcg
813331|NCT01349803|E4|Reported Event|Foradil® Aerolizer®|Formoterol Fumarate 12 μg
813332|NCT01349803|E3|Reported Event|GFF MDI (PT003)|GFF MDI 36/9.6 mcg
813333|NCT01349803|E2|Reported Event|GP MDI (PT001)|GP MDI 36 mcg
813334|NCT01349803|E1|Reported Event|FF MDI (PT005)|FF MDI 9.6 mcg
813335|NCT01349790|B1|Baseline|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813336|NCT01349790|P1|Participant Flow|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813337|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813338|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813339|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813340|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813341|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813342|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813343|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813344|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813345|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813346|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813347|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813348|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813349|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813350|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813351|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813352|NCT01349790|O1|Outcome|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813353|NCT01349790|E1|Reported Event|NewGam|Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
813354|NCT01349595|B3|Baseline|Total|Total of all reporting groups
813355|NCT01349595|B2|Baseline|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
813356|NCT01349595|B1|Baseline|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
813357|NCT01349595|P2|Participant Flow|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
813358|NCT01349595|P1|Participant Flow|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
813359|NCT01349595|O2|Outcome|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
813360|NCT01349595|O1|Outcome|Bortezomib|Bortezomib is a type of targeted chemotherapy
813361|NCT01349595|E2|Reported Event|Standard Post-transplant Treatment|Mayo Clinic standard post kidney transplant follow-up.
813362|NCT01349595|E1|Reported Event|Bortezomib|"Bortezomib is a type of targeted chemotherapy~Bortezomib: Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
813363|NCT01349491|B3|Baseline|Total|Total of all reporting groups
813364|NCT01349491|B2|Baseline|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
813365|NCT01349491|B1|Baseline|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
813366|NCT01349491|P2|Participant Flow|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
813367|NCT01349491|P1|Participant Flow|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
813394|NCT01349192|B3|Baseline|Total|Total of all reporting groups
813368|NCT01349491|O2|Outcome|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
813369|NCT01349491|O1|Outcome|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
813370|NCT01349491|E2|Reported Event|Placebo|"Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion.~Matching placebo: Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months."
813371|NCT01349491|E1|Reported Event|Ranolazine|"Patients will be started on ranolazine 500mg twice daily. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated.~Ranolazine: Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months."
813372|NCT01349465|B3|Baseline|Total|Total of all reporting groups
813373|NCT01349465|B2|Baseline|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813374|NCT01349465|B1|Baseline|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813375|NCT01349465|P2|Participant Flow|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813376|NCT01349465|P1|Participant Flow|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813377|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813378|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813379|NCT01349465|O2|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813380|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813381|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813382|NCT01349465|O1|Outcome|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813383|NCT01349465|O1|Outcome|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813384|NCT01349465|E3|Reported Event|Total|All Enrolled Subjects
813385|NCT01349465|E2|Reported Event|No SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813386|NCT01349465|E1|Reported Event|SVR at Last Post-Therapy Follow-up Visit of Previous Study|Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
813387|NCT01349231|B1|Baseline|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
813388|NCT01349231|P1|Participant Flow|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
813389|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
813390|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
813391|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
813392|NCT01349231|O1|Outcome|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
813393|NCT01349231|E1|Reported Event|Ketamine|"Ketamine will be given at a dose of 0.5mg/kg over 40 minutes. This dose is identical to that used in previous anti-depressant studies of ketamine.~ketamine: Ketamine (a single 0.5mg intravenously over 40 minutes)."
813395|NCT01349192|B2|Baseline|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
813396|NCT01349192|B1|Baseline|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
813397|NCT01349192|P2|Participant Flow|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
813398|NCT01349192|P1|Participant Flow|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
813399|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
813689|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813400|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
813401|NCT01349192|O2|Outcome|Observational|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
813402|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days.~Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days.~Environmental disinfection of high use areas"
813403|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
813404|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
813405|NCT01349192|O2|Outcome|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
813406|NCT01349192|O1|Outcome|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
813407|NCT01349192|E2|Reported Event|Observation|Subjects are tracked and not treated for their MRSA. If the subject reaches a protocol defined exacerbation within the first 28 days then they will be treated per choice of their primary Pulmonologist.
813408|NCT01349192|E1|Reported Event|Treatment|"Oral antibiotics:~Rifampin: Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.~Trimethoprim/Sulfamethoxazole: Adult Dose: 320/1600 orally twice daily for 14 days.~Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.~Alternative 2) Minocycline: subjects greater or equal to 8 years unable to take TMP/SMX or whose screening MRSA is resistant to TMP/SMX are prescribed minocycline.~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days max 200mg per day.~Topical:~Mupirocin: 1 gram 2% nasal ointment twice daily for 14 days. Topical: 0.12% chlorhexidine gluconate oral rinse: for 14 days. Environmental disinfection of high use areas"
813412|NCT01349114|P2|Participant Flow|Sugar Pill/Placebo|Sugar pill/placebo arm
813413|NCT01349114|P1|Participant Flow|Aliskiren|aliskiren 300 mg daily
813414|NCT01349114|O2|Outcome|Placebo|placebo: placebo
813415|NCT01349114|O1|Outcome|Aliskiren|"aliskiren 300 mg daily~aliskiren: aliskiren 300 mg daily"
813416|NCT01349114|O2|Outcome|Placebo|Sugar pill/ placebo
813417|NCT01349114|O1|Outcome|Aliskiren|aliskiren 300 mg daily
813418|NCT01349114|E2|Reported Event|Placebo|Sugar pill/ placebo
813419|NCT01349114|E1|Reported Event|Aliskiren|aliskiren 300 mg daily
813420|NCT01348854|B3|Baseline|Total|Total of all reporting groups
813421|NCT01348854|B2|Baseline|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
813422|NCT01348854|B1|Baseline|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
813423|NCT01348854|P2|Participant Flow|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
813424|NCT01348854|P1|Participant Flow|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
813425|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
813426|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
813427|NCT01348854|O2|Outcome|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
813428|NCT01348854|O1|Outcome|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
813429|NCT01348854|E2|Reported Event|Post Cataract With Residual Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct residual astigmatism in eyes that have undergone cataract extraction. May also include eyes with residual astigmatism following implantation of a phakic intraocular lens implanted.
813430|NCT01348854|E1|Reported Event|Natural Astigmatism|Use of the iFS Femtosecond Laser System to make arcuate incisions to correct naturally occurring corneal astigmatism in eyes with no prior history of ophthalmic surgery. May include eyes with cataracts.
813431|NCT01348789|B1|Baseline|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
813432|NCT01348789|P1|Participant Flow|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device - 3 treatments in 2-4 day intervals
813433|NCT01348789|O1|Outcome|Hair Clearance From All Areas|Treatment with Hair2Go (Mē) device
813434|NCT01348789|O6|Outcome|Dark Skin - Treat#3|Self assessment of tolerability for skin photo-type V-VI after treatment#3
813435|NCT01348789|O5|Outcome|Dark Skin - Treat#2|Self assessment of tolerability for skin photo-type V-VI after treatment#2
813436|NCT01348789|O4|Outcome|Dark Skin - Treat#1|Self assessment of tolerability for skin photo-type V-VI after treatment#1
813437|NCT01348789|O3|Outcome|Light Skin - Treat#3|Self assessment of tolerability for skin photo-type I-IV after treatment#3.
813438|NCT01348789|O2|Outcome|Light Skin - Treat#2|Self assessment of tolerability for skin photo-type I-IV after treatment#2.
813439|NCT01348789|O1|Outcome|Light Skin - Treat#1|Self assessment of tolerability for skin photo-type I-IV after treatment#1.
813440|NCT01348789|O1|Outcome|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
813441|NCT01348789|E1|Reported Event|Hair2Go (Mē)|Treatment with Hair2Go (Mē)device
813442|NCT01348776|B1|Baseline|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
813443|NCT01348776|P1|Participant Flow|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
813444|NCT01348776|O1|Outcome|Hair2Go (Mē)|Subjects treated with the Hair2Go (Me) Device
813445|NCT01348776|O4|Outcome|Maintenance Treatment #3|Self assessment of tolerability level of procedure during 3rd maintenance treatment
813446|NCT01348776|O3|Outcome|Treatment #7|Self assessment of tolerability level of procedure during 7th treatment
813447|NCT01348776|O2|Outcome|Treatment #3|Self assessment of tolerability level of procedure during 3rd treatment
813448|NCT01348776|O1|Outcome|Treatment #1|Self assessment of tolerability level of procedure during 1st treatment
813449|NCT01348776|O1|Outcome|Anticipated Skin Effects|Anticipated skin effects included mild to moderate sense of warmth, tingling, or itching, and transient erythema and edema.
813450|NCT01348776|O2|Outcome|No Maintenance Side|Hair clearance after 7 weekly treatments without additional maintenance treatments
813451|NCT01348776|O1|Outcome|Maintenance Side|Hair clearance after 7 weekly treatments+2 additional monthly maintenance treatments
813452|NCT01348776|O2|Outcome|Hair2Go (Mē) no Maintenance Side|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized NOT to receive maintenance treatments.
813453|NCT01348776|O1|Outcome|Hair2Go (Mē) Maintenance Side (Before Maintenance Tx)|Subjects treated with Hair2Go (Mē) Device:the treatment areas include the side that is randomized to receive maintenance treatments. This time point is before maintenance treatments were given.
813454|NCT01348776|E1|Reported Event|Hair2Go (Me)|Subjects treated with the Hair2Go (Me) Device
813455|NCT01348607|B4|Baseline|Total|Total of all reporting groups
813456|NCT01348607|B3|Baseline|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
813457|NCT01348607|B2|Baseline|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
813458|NCT01348607|B1|Baseline|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
813459|NCT01348607|P3|Participant Flow|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
813460|NCT01348607|P2|Participant Flow|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
813461|NCT01348607|P1|Participant Flow|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
813462|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
813463|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
813464|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
813465|NCT01348607|O3|Outcome|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
813466|NCT01348607|O2|Outcome|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
813467|NCT01348607|O1|Outcome|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
813468|NCT01348607|E3|Reported Event|Arm III Placebo|Patients receive oral placebo once daily for 7-42 days in the absence of unacceptable toxicity.
813469|NCT01348607|E2|Reported Event|Arm II -Modafinil|Patients receive oral modafinil once daily for 7-42 days in the absence of unacceptable toxicity.
813690|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813470|NCT01348607|E1|Reported Event|Arm I - Methylphenidate Hydrochloride|Patients receive oral methylphenidate extended-release once daily for 7-42 days in the absence of unacceptable toxicity.
813471|NCT01348425|B3|Baseline|Total|Total of all reporting groups
813472|NCT01348425|B2|Baseline|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
813473|NCT01348425|B1|Baseline|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
813474|NCT01348425|P2|Participant Flow|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
813475|NCT01348425|P1|Participant Flow|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
813476|NCT01348425|O2|Outcome|Shorter Stents|Shorter Zilver PTX Stents : Treatment with Zilver PTX stents 80 mm or shorter only
813477|NCT01348425|O1|Outcome|Longer Stents|Longer Zilver PTX Stents : Treatment with at least one 100 mm or longer Zilver PTX stent
813478|NCT01348425|E1|Reported Event|Stented Patients|The adverse events were combined because all patients were treated with Zilver PTX stents. The safety of Zilver PTX has been previously established and the primary objective of this study was changes in post-deployment stent length; i.e. immediately post-procedure.
813479|NCT01348165|B8|Baseline|Total|Total of all reporting groups
813480|NCT01348165|B7|Baseline|0.6 mg|BI 137882 with 0.6 mg Dose level
813481|NCT01348165|B6|Baseline|0.5 mg|BI 137882 with 0.5 mg Dose level
813482|NCT01348165|B5|Baseline|0.25 mg|BI 137882 with 0.25 mg Dose level
813483|NCT01348165|B4|Baseline|0.1 mg|BI 137882 with 0.1 mg Dose level
813484|NCT01348165|B3|Baseline|0.03 mg|BI 137882 with 0.03 mg Dose level
813485|NCT01348165|B2|Baseline|0.01 mg|BI 137882 with 0.01 mg Dose level
813486|NCT01348165|B1|Baseline|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813487|NCT01348165|P7|Participant Flow|0.6 mg|BI 137882 with 0.6 mg Dose level
813488|NCT01348165|P6|Participant Flow|0.5 mg|BI 137882 with 0.5 mg Dose level
813489|NCT01348165|P5|Participant Flow|0.25 mg|BI 137882 with 0.25 mg Dose level
813490|NCT01348165|P4|Participant Flow|0.1 mg|BI 137882 with 0.1 mg Dose level
813491|NCT01348165|P3|Participant Flow|0.03 mg|BI 137882 with 0.03 mg Dose level
813492|NCT01348165|P2|Participant Flow|0.01 mg|BI 137882 with 0.01 mg Dose level
813493|NCT01348165|P1|Participant Flow|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
813494|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813495|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813496|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813497|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813498|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813499|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813500|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813501|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813502|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813503|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813504|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813505|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813506|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813507|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813508|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813509|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813510|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813511|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813512|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813513|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813514|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813515|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813519|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813520|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813521|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813522|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813523|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813524|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813525|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813526|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813527|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813528|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813529|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813530|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813531|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813532|NCT01348165|O6|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813533|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813534|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813535|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813536|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813537|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813538|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813539|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813540|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813541|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813544|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813545|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813546|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813547|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813548|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813549|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813550|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813551|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813552|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813553|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813554|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813555|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813556|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813557|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813558|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813559|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813560|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813561|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813562|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813563|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813564|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813565|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813566|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813567|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813568|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813569|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813570|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813571|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813572|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813573|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813574|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813575|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813576|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813577|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813578|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813579|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813580|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813581|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813582|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813583|NCT01348165|O3|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813584|NCT01348165|O2|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813585|NCT01348165|O1|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813586|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813587|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813588|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813589|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813590|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813591|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813592|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813593|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813594|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813595|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813596|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813599|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813600|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813601|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813602|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813603|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813604|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813605|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813606|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813607|NCT01348165|O7|Outcome|0.6 mg|BI 137882 with 0.6 mg Dose level
813608|NCT01348165|O6|Outcome|0.5 mg|BI 137882 with 0.5 mg Dose level
813609|NCT01348165|O5|Outcome|0.25 mg|BI 137882 with 0.25 mg Dose level
813610|NCT01348165|O4|Outcome|0.1 mg|BI 137882 with 0.1 mg Dose level
813611|NCT01348165|O3|Outcome|0.03 mg|BI 137882 with 0.03 mg Dose level
813612|NCT01348165|O2|Outcome|0.01 mg|BI 137882 with 0.01 mg Dose level
813613|NCT01348165|O1|Outcome|Placebo|A solution of 0.7% SDS and volume depends on corresponding dose group
813614|NCT01348165|E7|Reported Event|0.6 mg|BI 137882 with 0.6 mg Dose level
813615|NCT01348165|E6|Reported Event|0.5 mg|BI 137882 with 0.5 mg Dose level
813616|NCT01348165|E5|Reported Event|0.25 mg|BI 137882 with 0.25 mg Dose level
813617|NCT01348165|E4|Reported Event|0.1 mg|BI 137882 with 0.1 mg Dose level
813618|NCT01348165|E3|Reported Event|0.03 mg|BI 137882 with 0.03 mg Dose level
813619|NCT01348165|E2|Reported Event|0.01 mg|BI 137882 with 0.01 mg Dose level
813620|NCT01348165|E1|Reported Event|Placebo|A solution of 0.7% sodium dodecyl sulphate (SDS) and volume depends on corresponding dose group
813621|NCT01348139|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
813691|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813622|NCT01348139|P6|Participant Flow|Placebo / 1200 μg / 1400 μg / 300 μg / 880 μg / 800 μg|Placebo followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by AZD3199 800 μg SID.
813623|NCT01348139|P5|Participant Flow|1200 μg / 300 μg / Placebo / 800 μg / 1400 μg / 880 μg|AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 300 μg Turbuhaler inhaler followed by Placebo followed by AZD3199 800 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 880 μg SID.
813624|NCT01348139|P4|Participant Flow|300 μg / 800 μg / 1200 μg / 880 μg / Placebo / 1400 μg|AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 880 μg SID followed by Placebo followed by AZD3199 1400 μg SID.
813625|NCT01348139|P3|Participant Flow|800 μg / 880 μg / 300 μg / 1400 μg / 1200 μg / Placebo|AZD3199 800 μg SID followed by AZD3199 880 μg SID followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1400 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by Placebo.
813626|NCT01348139|P2|Participant Flow|880 μg / 1400 μg / 800 μg / Placebo / 300 μg / 1200 μg|AZD3199 880 μg SID followed by AZD3199 1400 μg SID followed by AZD3199 800 μg SID followed by Placebo followed by AZD3199 300 μg Turbuhaler inhaler followed by AZD3199 1200 μg Turbuhaler inhaler.
813627|NCT01348139|P1|Participant Flow|1400 μg / Placebo / 880 μg / 1200 μg / 800 μg / 300 μg|AZD3199 1400 μg SID followed by Placebo followed by AZD3199 880 μg SID followed by AZD3199 1200 μg Turbuhaler inhaler followed by AZD3199 800 μg SID followed by AZD3199 300 μg Turbuhaler inhaler.
813628|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813629|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813630|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813631|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813632|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813633|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813634|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813635|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813636|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813637|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813638|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813639|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813640|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813641|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813642|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813643|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813644|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813645|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813646|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813647|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813648|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813649|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813650|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813651|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813652|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813653|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813654|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813655|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813656|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813657|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813658|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813659|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813660|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813661|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813663|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813664|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813665|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813666|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813667|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813668|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813669|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813670|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813671|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813672|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813673|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813674|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813675|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813676|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813677|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813678|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813679|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813680|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813681|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813682|NCT01348139|O6|Outcome|Arm 6 - Placebo|Placebo
813683|NCT01348139|O5|Outcome|Arm 5 - AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813684|NCT01348139|O4|Outcome|Arm 4 - AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813685|NCT01348139|O3|Outcome|Arm 3 - AZD3199 800 μg|AZD3199 800 μg SID
813686|NCT01348139|O2|Outcome|Arm 2 - AZD3199 880 μg|AZD3199 880 μg SID
813687|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813693|NCT01348139|O1|Outcome|Arm 1 - AZD3199 1400 μg|AZD3199 1400 μg SID
813694|NCT01348139|E6|Reported Event|Placebo|Placebo
813695|NCT01348139|E5|Reported Event|AZD3199 1200 μg|AZD3199 1200 μg Turbuhaler inhaler
813696|NCT01348139|E4|Reported Event|AZD3199 300 μg|AZD3199 300 μg Turbuhaler inhaler
813697|NCT01348139|E3|Reported Event|AZD3199 800 μg|AZD3199 800 μg SID
813698|NCT01348139|E2|Reported Event|AZD3199 880 μg|AZD3199 880 μg SID
813699|NCT01348139|E1|Reported Event|AZD3199 1400 μg|AZD3199 1400 μg SID
813700|NCT01348100|B8|Baseline|Total|Total of all reporting groups
813701|NCT01348100|B7|Baseline|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813702|NCT01348100|B6|Baseline|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813703|NCT01348100|B5|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813704|NCT01348100|B4|Baseline|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813705|NCT01348100|B3|Baseline|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813706|NCT01348100|B2|Baseline|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
813707|NCT01348100|B1|Baseline|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
813708|NCT01348100|P7|Participant Flow|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813709|NCT01348100|P6|Participant Flow|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813710|NCT01348100|P5|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813755|NCT01348100|E3|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time.
813711|NCT01348100|P4|Participant Flow|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813712|NCT01348100|P3|Participant Flow|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813713|NCT01348100|P2|Participant Flow|Iloperidone 125 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
813714|NCT01348100|P1|Participant Flow|Iloperidone 50 mg Crystalline Formulation - Phase A|Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
813715|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813716|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813717|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813718|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813719|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813720|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813721|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813722|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813723|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813724|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813725|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813726|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813727|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813728|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813729|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813730|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813793|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813731|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813732|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813733|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813734|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813735|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813736|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813737|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813738|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813809|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813739|NCT01348100|O3|Outcome|Iloperidone 625 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813740|NCT01348100|O2|Outcome|Iloperidone 500 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813741|NCT01348100|O1|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase C|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813742|NCT01348100|O2|Outcome|Iloperidone 250 mg Microparticle Formulation - Phase B|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813743|NCT01348100|O1|Outcome|Iloperidone 250 mg Crystalline Formulation - Phase B|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813744|NCT01348100|E14|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart.
813745|NCT01348100|E13|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart.
813746|NCT01348100|E12|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart.
813747|NCT01348100|E11|Reported Event|Iloperidone 625 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813748|NCT01348100|E10|Reported Event|Iloperidone 500 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813749|NCT01348100|E9|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase C Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813750|NCT01348100|E8|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Depot|Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time.
813751|NCT01348100|E7|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Depot|Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time.
813752|NCT01348100|E6|Reported Event|Iloperidone 250 mg Microparticle Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813753|NCT01348100|E5|Reported Event|Iloperidone 250 mg Crystalline Formulation - Phase B Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.
813754|NCT01348100|E4|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Depot|Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time.
813756|NCT01348100|E2|Reported Event|Iloperidone 125 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
813757|NCT01348100|E1|Reported Event|Iloperidone 50 mg Crystalline Formulation - Phase A Oral|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.
813758|NCT01348087|B1|Baseline|AFQ056|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
813759|NCT01348087|P1|Participant Flow|AFQ056 Total|Participants from a previous AFQ056 study who entered the open-label extension study were administered AFQ056 capsules at a starting dose of 25 milligram (mg) twice daily (bid) and then titrated to 50 mg bid, 75 mg bid and 100 mg bid at weekly intervals
813760|NCT01348087|O6|Outcome|AFQ056 Total|
813761|NCT01348087|O5|Outcome|AFQ056 100mg Bid|
813762|NCT01348087|O4|Outcome|AFQ056 75mg Bid|
813763|NCT01348087|O3|Outcome|AFQ056 50mg Bid|
813764|NCT01348087|O2|Outcome|AFQ056 25mg Bid|
813765|NCT01348087|O1|Outcome|Prior to Ext First Dose|
813766|NCT01348087|E6|Reported Event|AFQ056 Total|
813767|NCT01348087|E5|Reported Event|AFQ056 100 mg Bid|AFQ056 100 mg bid
813768|NCT01348087|E4|Reported Event|AFQ056 75 mg Bid|AFQ056 75 mg bid
813769|NCT01348087|E3|Reported Event|AFQ056 50 mg Bid|AFQ056 50 mg bid
813770|NCT01348087|E2|Reported Event|AFQ056 25 mg Bid|AFQ056 25 mg bid
813771|NCT01348087|E1|Reported Event|Prior to Ext.First Dose|Prior to Ext.first dose
813772|NCT01347931|B1|Baseline|Overall Study Group|All subjects participating in 2-way crossover design study
813773|NCT01347931|P1|Participant Flow|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~Breathe NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813810|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
814593|NCT01345591|E1|Reported Event|Fat Grafting|fat grafting for facial trauma
813774|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813775|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813776|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813777|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813778|NCT01347931|O2|Outcome|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813779|NCT01347931|O1|Outcome|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813780|NCT01347931|E2|Reported Event|Breathe NIOV System|"Noninvasive ventilation delivered via NIOV System oxygen using an open nasal interface. Connected to standard portable oxygen cylinder~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813781|NCT01347931|E1|Reported Event|Standard Oxygen Therapy|"Supplemental oxygen delivered via standard nasal cannula connected to a portable oxygen cylinder.~NIOV System: Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living."
813782|NCT01347879|B3|Baseline|Total|Total of all reporting groups
813783|NCT01347879|B2|Baseline|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813784|NCT01347879|B1|Baseline|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813785|NCT01347879|P2|Participant Flow|Visonac Cream With PDT|"active treatment with light dose of 37 J/cm2~Visonac photodynamic therapy (PDT): cream application prior to illumination with red light"
813786|NCT01347879|P1|Participant Flow|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813787|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813788|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813789|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813790|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813791|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813792|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813831|NCT01347788|P3|Participant Flow|Expansion Cohort|Cabozantinib 40 mg daily
813794|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813795|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813796|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813797|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813798|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813799|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813800|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813801|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813802|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813803|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813804|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813805|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813806|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813807|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813808|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813811|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813812|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813813|NCT01347879|O2|Outcome|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813814|NCT01347879|O1|Outcome|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813815|NCT01347879|E2|Reported Event|Visonac Cream With PDT|"active treatment with light dose of 37J/cm2~Visonac PDT : cream application prior to illumination with red light"
813816|NCT01347879|E1|Reported Event|Vehicle Cream With PDT|"Placebo treatment, Light dose 37 J/cm2~Visonac PDT : cream application prior to illumination with red light"
813817|NCT01347840|B1|Baseline|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813818|NCT01347840|P1|Participant Flow|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813819|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813820|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813821|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813822|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813823|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813824|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813825|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813826|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813827|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813828|NCT01347840|O1|Outcome|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813829|NCT01347840|E1|Reported Event|All Subjects|This is a one arm study where all the subjects will receive the same treatment and will not be blinded. No subjects will be assigned to different treatment groups.
813830|NCT01347788|B1|Baseline|Cabozantinib|"Final results have been published Clin Cancer Res. 2013 Jun 1;19(11):3088-94. doi: 10.1158/1078-0432.CCR-13-0319. Epub 2013 Apr 3.~A dose-ranging study of cabozantinib in men with castration-resistant prostate cancer and bone metastases.~Lee RJ, Saylor PJ, Michaelson MD, Rothenberg SM, Smas ME, Miyamoto DT, Gurski CA, Xie W, Maheswaran S, Haber DA, Goldin JG, Smith MR.~Author information Massachusetts General Hospital Cancer Center, Boston, Massachusetts 02114, USA. rjlee@partners.org"
813832|NCT01347788|P2|Participant Flow|Dose Level -1|Cabozantinib 20 mg daily
813833|NCT01347788|P1|Participant Flow|Dose Level 0|Cabozantinib 40 mg daily
813834|NCT01347788|O3|Outcome|Expansion Cohort|Dose level 0: cabozantinib 40 mg daily
813835|NCT01347788|O2|Outcome|Cohort 2|Dose level -1: cabozantinib 20 mg daily
813836|NCT01347788|O1|Outcome|Cohort 1|Dose level 0: cabozantinib 40 mg daily
813837|NCT01347788|E3|Reported Event|Cohort 3|Dose level 0: cabozantinib 40 mg daily
813838|NCT01347788|E2|Reported Event|Cohort 2|Dose level -1: cabozantinib 20 mg daily
813839|NCT01347788|E1|Reported Event|Cohort 1|Dose level 0: cabozantinib 40 mg daily
813840|NCT01347710|B1|Baseline|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
813841|NCT01347710|P1|Participant Flow|Flurpiridaz F 18|Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
813842|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
813843|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813844|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813845|NCT01347710|O1|Outcome|Flurpiridaz F18|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813846|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
815430|NCT01342523|P32|Participant Flow|CIS/Loz/Emails/Full Website/Full Booklet|
813847|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813848|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813849|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
813850|NCT01347710|O1|Outcome|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
813851|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813852|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813853|NCT01347710|O1|Outcome|Flurpiridaz F18 PET MPI|"Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization~Flurpiridaz F18: Injection of Flurpiridaz F18 for the purposes of PET MPI analysis"
813854|NCT01347710|E1|Reported Event|Flurpiridaz F 18|Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
813855|NCT01347632|B1|Baseline|Metronidazole|Open Label Study
813856|NCT01347632|P1|Participant Flow|Metronidazole|Open Label Study
813857|NCT01347632|O1|Outcome|Metronidazole|Open Label Study
813858|NCT01347632|E1|Reported Event|Metronidazole|Open Label Study
813859|NCT01347580|B3|Baseline|Total|Total of all reporting groups
813860|NCT01347580|B2|Baseline|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813861|NCT01347580|B1|Baseline|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813862|NCT01347580|P2|Participant Flow|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813863|NCT01347580|P1|Participant Flow|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813864|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813865|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813866|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813867|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813868|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813869|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813870|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813871|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813872|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813873|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813874|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813875|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813876|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813877|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813878|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813879|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813880|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
814591|NCT01345591|O2|Outcome|Fat Graft Volume at 9 Months|fat grafting for facial trauma, volume measured at 9 months post-op
813881|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813882|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813883|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813884|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813885|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813886|NCT01347580|O2|Outcome|In-hospital Ticagrelor|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813887|NCT01347580|O1|Outcome|Pre-hospital Ticagrelor|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813888|NCT01347580|E2|Reported Event|Ticagrelor Pre-Hosp|Loading dose of Ticagrelor (180 mg) followed by matching placebo. After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813889|NCT01347580|E1|Reported Event|Ticagrelor In-Hosp|Placebo followed by a loading dose of Ticagrelor (180 mg). After the loading dose the patient will receive Ticagrelor (90 mg bid) for 30 days.
813890|NCT01347554|B3|Baseline|Total|Total of all reporting groups
813891|NCT01347554|B2|Baseline|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
813892|NCT01347554|B1|Baseline|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
813893|NCT01347554|P2|Participant Flow|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
813894|NCT01347554|P1|Participant Flow|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
813895|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
813896|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
813897|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
813898|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
813899|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
813900|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
813901|NCT01347554|O2|Outcome|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
813902|NCT01347554|O1|Outcome|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
813903|NCT01347554|E2|Reported Event|Endeavor Resolute Group|Endeavor resolute (Zotarolimus eluting stent) insertion in patients with acute myocardial infarction
813904|NCT01347554|E1|Reported Event|Xience V Stent Group|Xience V (Everolimus eluting stent) insertion in patients with acute myocardial infarction
813940|NCT01347112|E1|Reported Event|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
813941|NCT01347086|B11|Baseline|Total|Total of all reporting groups
815865|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
813905|NCT01347255|B1|Baseline|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks (6 days a week)~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4 weeks (6 days a week)~Daivobet® ointment: once daily application, 4 weeks (6 days a week)"
813906|NCT01347255|P1|Participant Flow|All Study Participants|"All subjects received all four treatments:~LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle w. betamethasone. Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)~LEO 90100 cutaneous spray, ointment, vehicle. Served as a negative control for the two cutaneous spray ointments with active ingredients~Daivobet® ointment. Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)~Four test sites of approximately 5 cm2 were selected on predetermined psoriasis lesions (target plaques), delimited with a disposable circular device and mapped on a drawn figure.~The distance between two test sites was at least 2 cm. The products were applied on the four test sites (according to random assignment to specific test sites selected on the psoriasis plaque) once daily 6 days a week (except Sundays) for 4 weeks."
813907|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
813908|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
813909|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
813910|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
813911|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
813912|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
813913|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
813914|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
813915|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
813916|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
813917|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
813918|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
813919|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
813920|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
813921|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
813922|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
813923|NCT01347255|O4|Outcome|Daivobet® Ointment|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate)
813924|NCT01347255|O3|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle|LEO 90100 vehicle served as a negative control for the two cutaneous spray ointments with active ingredients.
813925|NCT01347255|O2|Outcome|LEO 90100 Cutaneous Spray, Ointment, Vehicle w. Betamethasone|Vehicle cutaneous spray, ointment, with betamethasone 0.5 mg/g (as dipropionate)
813926|NCT01347255|O1|Outcome|LEO 90100 Cutaneous Spray, Ointment|LEO 90100 cutaneous spray, ointment, is a new product containing calcipotriol 50 mcg/g and betamethasone 0.5 mg/g (as dipropionate).
813927|NCT01347255|E1|Reported Event|LEO 90100 Cutaneous Spray, Ointment|"Intra-Individual baseline analysis population, all treated with the following four products:~LEO 90100 cutaneous spray, ointment: once daily application, 4weeks~LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate: once daily application, 4 weeks~LEO 90100 cutaneous spray, ointment, vehicle: once daily application, 4weeks~Daivobet® ointment: once daily application, 4weeks"
813928|NCT01347112|B3|Baseline|Total|Total of all reporting groups
813929|NCT01347112|B2|Baseline|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
813930|NCT01347112|B1|Baseline|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
813931|NCT01347112|P2|Participant Flow|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
813932|NCT01347112|P1|Participant Flow|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
813933|NCT01347112|O2|Outcome|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
813934|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
813935|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
813936|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
813937|NCT01347112|O2|Outcome|Sugar Pil|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
813938|NCT01347112|O1|Outcome|Varenicline|"varenicline 1.0 mg twice daily for 12 weeks~Varenicline: varenicline 1.0 mg dose, twice daily for 12 weeks"
813939|NCT01347112|E2|Reported Event|Sugar Pill|"Varenicline look alike sugar pill twice daily for 12 weeks~placebo: sugar pill twice daily for 12 weeks"
813942|NCT01347086|B10|Baseline|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
813943|NCT01347086|B9|Baseline|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813944|NCT01347086|B8|Baseline|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813945|NCT01347086|B7|Baseline|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813946|NCT01347086|B6|Baseline|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
813947|NCT01347086|B5|Baseline|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813948|NCT01347086|B4|Baseline|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813949|NCT01347086|B3|Baseline|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813950|NCT01347086|B2|Baseline|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
813951|NCT01347086|B1|Baseline|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813952|NCT01347086|P10|Participant Flow|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813953|NCT01347086|P9|Participant Flow|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813954|NCT01347086|P8|Participant Flow|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813955|NCT01347086|P7|Participant Flow|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
813956|NCT01347086|P6|Participant Flow|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
815431|NCT01342523|P31|Participant Flow|CIS/Loz/no Emails/Full Website/Full Booklet|
813957|NCT01347086|P5|Participant Flow|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813958|NCT01347086|P4|Participant Flow|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813959|NCT01347086|P3|Participant Flow|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
813960|NCT01347086|P2|Participant Flow|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813961|NCT01347086|P1|Participant Flow|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
813962|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813963|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813964|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813965|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813966|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813967|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813968|NCT01347086|O6|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813969|NCT01347086|O5|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813970|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813971|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813972|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813973|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813974|NCT01347086|O3|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813975|NCT01347086|O2|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813976|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813977|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813978|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813979|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813980|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813981|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813982|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813983|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813984|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813985|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813986|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813987|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813988|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813989|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813990|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813991|NCT01347086|O5|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813992|NCT01347086|O4|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813993|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813994|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813995|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813996|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813997|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813998|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
813999|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
815432|NCT01342523|P30|Participant Flow|CIS/no Loz/Emails/Full Website/Full Booklet|
814000|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814001|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814002|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814003|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814004|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814005|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814006|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814007|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814008|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814009|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814010|NCT01347086|O4|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814011|NCT01347086|O3|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814012|NCT01347086|O2|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814013|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814014|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814015|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814016|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814017|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814018|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814019|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814020|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814021|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814022|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814023|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814024|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814025|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814026|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814027|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814071|NCT01347060|B3|Baseline|Total|Total of all reporting groups
814028|NCT01347086|O7|Outcome|Chinese 1200 mg|"Chinese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814029|NCT01347086|O6|Outcome|Chinese 800 mg|"Chinese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814030|NCT01347086|O5|Outcome|Chinese 400 mg|"Chinese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814031|NCT01347086|O4|Outcome|Japanese 1200 mg|"Japanese subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814032|NCT01347086|O3|Outcome|Japanese 800 mg|"Japanese subjects who received a single dose of 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814033|NCT01347086|O2|Outcome|Japanese 400 mg|"Japanese subjects who received a single dose of 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814034|NCT01347086|O1|Outcome|Caucasian 1200 mg|"Caucasian subjects who received a single dose of 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814035|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
814036|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814037|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814038|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814039|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
814040|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814041|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814042|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814043|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
814044|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814045|NCT01347086|O10|Outcome|Placebo (Chinese Subjects)|"Chinese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
814046|NCT01347086|O9|Outcome|1200 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814047|NCT01347086|O8|Outcome|800 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814048|NCT01347086|O7|Outcome|400 mg Deleobuvir (Chinese Subjects)|"Chinese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814049|NCT01347086|O6|Outcome|Placebo (Japanese Subjects)|"Japanese subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
814050|NCT01347086|O5|Outcome|1200mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814051|NCT01347086|O4|Outcome|800 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 800 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814052|NCT01347086|O3|Outcome|400 mg Deleobuvir (Japanese Subjects)|"Japanese subjects who received 400 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814053|NCT01347086|O2|Outcome|Placebo (Caucasian Subjects)|"Caucasian subjects who received matching placebo.~Oral with 240 mL of water in fed condition."
814054|NCT01347086|O1|Outcome|1200 mg Deleobuvir (Caucasian Subjects)|"Caucasian subjects who received 1200 mg Deleobuvir.~Oral with 240 mL of water in fed condition."
814055|NCT01347086|E4|Reported Event|1200 mg Deleobuvir|All (Caucasian, Japanese and Chinese) subjects that received 1200 mg Deleobuvir. Oral with 240 mL of water in fed condition.
814056|NCT01347086|E3|Reported Event|800 mg Deleobuvir|All (Japanese and Chinese) subjects that received 800 mg Deleobuvir. Oral with 240 mL of water in fed condition.
814057|NCT01347086|E2|Reported Event|400 mg Deleobuvir|All (Japanese and Chinese) subjects that received 400 mg Deleobuvir. Oral with 240 mL of water in fed condition.
814058|NCT01347086|E1|Reported Event|Placebo|All (Caucasian, Japanese and Chinese) subjects that received matching placebo. Oral with 240 mL of water in fed condition.
814059|NCT01347073|B1|Baseline|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
814060|NCT01347073|P1|Participant Flow|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
814061|NCT01347073|O1|Outcome|HPN-100|Long Term Treatment
814062|NCT01347073|O2|Outcome|Long-term Phase|The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
814063|NCT01347073|O1|Outcome|Pre-enrollment|12-months preceding the study
814064|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
814065|NCT01347073|O1|Outcome|NaPBA|Switch Over
814066|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment
814067|NCT01347073|O1|Outcome|NaPBA|Switch Over
814068|NCT01347073|O2|Outcome|HPN-100|Switch Over and Long Term Treatment Arm
814069|NCT01347073|O1|Outcome|NaPBA|Switch Over Arm
814070|NCT01347073|E1|Reported Event|HPN-100|The first part of this open-label study consisted of a switch-over period during which patients were switched from the current medication (NaPBA) to HPN-100. The second part of this open-label study consisted of a 12-month long-term treatment phase with HPN-100. All participants in the switch-over were enrolled into the long-term treatment phase.
814072|NCT01347060|B2|Baseline|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814073|NCT01347060|B1|Baseline|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
814074|NCT01347060|P2|Participant Flow|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814075|NCT01347060|P1|Participant Flow|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
814076|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814077|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
814405|NCT01345929|E1|Reported Event|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
814078|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814079|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
814080|NCT01347060|O2|Outcome|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814081|NCT01347060|O1|Outcome|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
814082|NCT01347060|E2|Reported Event|Inhaled Corticosteroids|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Inhaled Corticosteroids (beclomethasone dipropionate, fluticasone propionate, mometasone furoate, triamcinolone, flunisolide, budesoninde). Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814083|NCT01347060|E1|Reported Event|Fluticasone Propionate and Salmeterol|Participants aged 65-79 years with 15-24 months of continuous enrollment (12 months pre-index and 3-12 months post-index), with asthma diagnosis, and who received (index) Fluticasone Propionate and Salmeterol 100 micrograms (mcg)/50 mcg, 250 mcg/50 mcg, and 500 mcg/50 mcg
814084|NCT01347034|B3|Baseline|Total|Total of all reporting groups
814085|NCT01347034|B2|Baseline|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
814086|NCT01347034|B1|Baseline|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
814087|NCT01347034|P2|Participant Flow|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
814088|NCT01347034|P1|Participant Flow|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
814089|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
814090|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
814091|NCT01347034|O2|Outcome|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
814092|NCT01347034|O1|Outcome|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
814093|NCT01347034|E2|Reported Event|Experimental: External Beam RT + DC Injection|Arm B - Moffitt Cancer Center - External Beam RT + Autologous Dendritic Cells (DC) Injection - As outlined in Intervention Description
814094|NCT01347034|E1|Reported Event|Active Comparator: External Beam Radiation Therapy (RT)|Arm A - University of Florida - External Beam Radiation Therapy (RT) - As outlined in Intervention Description
814095|NCT01347008|B3|Baseline|Total|Total of all reporting groups
814096|NCT01347008|B2|Baseline|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
814097|NCT01347008|B1|Baseline|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
814098|NCT01347008|P2|Participant Flow|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
814099|NCT01347008|P1|Participant Flow|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
814100|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
814101|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
814102|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
814103|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
814104|NCT01347008|O2|Outcome|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
814105|NCT01347008|O1|Outcome|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
814106|NCT01347008|E2|Reported Event|Sugar Pill|Placebo: Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
814107|NCT01347008|E1|Reported Event|Sildenafil Citrate|"Oral Sildenafil citrate, 50mg, b.i.d.~Sildenafil citrate: Oral sildenafil citratre, 50mg b.i.d., 8 weeks"
814108|NCT01346852|B3|Baseline|Total|Total of all reporting groups
814109|NCT01346852|B2|Baseline|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814340|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814110|NCT01346852|B1|Baseline|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814111|NCT01346852|P2|Participant Flow|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814112|NCT01346852|P1|Participant Flow|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814113|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814114|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814115|NCT01346852|O2|Outcome|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814116|NCT01346852|O1|Outcome|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814117|NCT01346852|E2|Reported Event|Adult Participants Diagnosed With Asthma|Adult (>=18 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814118|NCT01346852|E1|Reported Event|Pediatric Participants Diagnosed With Asthma|Pediatric (4-17 years old) participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication during the enrollment period (January 1, 2004 to June 30, 2006) and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol. Due to the retrospective nature of this analysis, doses received and frequency of dosing are not known.
814119|NCT01346839|B3|Baseline|Total|Total of all reporting groups
814142|NCT01346774|O1|Outcome|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
814143|NCT01346774|E2|Reported Event|Placebo Capsules|Placebo powder: 2 placebo powder capsules twice a day
814120|NCT01346839|B2|Baseline|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814121|NCT01346839|B1|Baseline|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814152|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814298|NCT01346475|P2|Participant Flow|High-dose Valacyclovir First Then Standard-dose Valacyclovir|High-dose valacyclovir (1 gram three times daily) for 5 weeks followed by 1 week wash-out and then standard-dose valacyclovir (500 mg daily) for 5 weeks
814122|NCT01346839|P2|Participant Flow|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814123|NCT01346839|P1|Participant Flow|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814124|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814125|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814126|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814127|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814144|NCT01346774|E1|Reported Event|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
814145|NCT01346592|B4|Baseline|Total|Total of all reporting groups
814146|NCT01346592|B3|Baseline|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814266|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707.
814128|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814129|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814130|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814131|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814132|NCT01346839|O2|Outcome|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814133|NCT01346839|O1|Outcome|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814134|NCT01346839|E2|Reported Event|Usual Care Control|The usual care at MEDVAMC consists of providers using an advanced EHR and its notification system (the View Alert system) that immediately alerts providers about clinically significant events. The system relies primarily on computerized notification (alerts) displayed prominently through a “View Alert” window that is displayed in the EHR every time a provider signs on or switches between patient records. The system does not require providers to read alerts, and providers do have an option of ignoring the View Alert window to bypass it. At SWHS there is a navigation program for patients who have received a cancer diagnosis by tissue biopsy. However, currently there is no routine tracking of patients if they do not show for their scheduled appointments and tests at SWHS.
814135|NCT01346839|E1|Reported Event|Contact Intervention|"The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.~Contact Intervention: The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites."
814136|NCT01346774|B3|Baseline|Total|Total of all reporting groups
814137|NCT01346774|B2|Baseline|Placebo|Placebo powder: 2 placebo powder capsules twice a day
814138|NCT01346774|B1|Baseline|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
814139|NCT01346774|P2|Participant Flow|Placebo|Placebo powder: 2 placebo powder capsules twice a day
814140|NCT01346774|P1|Participant Flow|Cranberry Capsules|Cranberry powder: 2 cranberry powder capsules twice a day
814141|NCT01346774|O2|Outcome|Placebo|Placebo powder: 2 placebo powder capsules twice a day
814147|NCT01346592|B2|Baseline|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814148|NCT01346592|B1|Baseline|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814149|NCT01346592|P3|Participant Flow|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814150|NCT01346592|P2|Participant Flow|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814151|NCT01346592|P1|Participant Flow|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814401|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
814153|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814154|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814155|NCT01346592|O3|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814156|NCT01346592|O2|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814157|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814158|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814159|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814160|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814161|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814162|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814163|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814164|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814165|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814166|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814167|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
814168|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814169|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814170|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
814171|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814172|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814173|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
814174|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814175|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814176|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
814177|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814178|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814179|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
814180|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814181|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814402|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
814182|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
814183|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814184|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814185|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
814186|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814187|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814188|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
814189|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814190|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814191|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
814192|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814193|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814194|NCT01346592|O9|Outcome|TIV (36 to <72 Months)|Subjects received one dose (Day 1) of an investigational trivalent split influenza vaccine (TIV)
814195|NCT01346592|O8|Outcome|Comparator TIV (36 to <72 Months)|Subjects received one dose (Day 1) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814196|NCT01346592|O7|Outcome|aTIV (36 to <72 Months)|Subjects received one dose (Day 1) of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814197|NCT01346592|O6|Outcome|TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational trivalent split influenza vaccine (TIV)
814198|NCT01346592|O5|Outcome|Compartor TIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of a licensed comparator trivalent split influenza vaccine (comparator TIV)
814199|NCT01346592|O4|Outcome|aTIV (6 to <36 Months)|Subjects received two doses (Day 1 & 29) of an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV)
814200|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
814201|NCT01346592|O2|Outcome|Compartor TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814202|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814203|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814204|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814205|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
815234|NCT01343004|P2|Participant Flow|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
814206|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814207|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814208|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814209|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814210|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814406|NCT01345786|B5|Baseline|Total|Total of all reporting groups
814211|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814212|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814213|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814214|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814215|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814216|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814217|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814218|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814219|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814220|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814221|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
814222|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
814223|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
814224|NCT01346592|O3|Outcome|TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
814225|NCT01346592|O2|Outcome|Comparator TIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the licensed comparator trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
814226|NCT01346592|O1|Outcome|aTIV (6 to <24 Months)|Subjects received two doses of 0.25 mL each, of the investigational MF59-adjuvanted trivalent split influenza vaccine (aTIV), at Days 1 & 29
814227|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
814228|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
814229|NCT01346592|O2|Outcome|Comparator TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of the licensed trivalent split influenza vaccine (comparator TIV), at Days 1 & 29
814230|NCT01346592|O1|Outcome|TIV (6 to <36months)|Subjects received two doses of 0.25 mL each, of investigational trivalent split influenza vaccine (TIV), at Days 1 & 29
814231|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814232|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814233|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814234|NCT01346592|O3|Outcome|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (Day 1) of the vaccine
814235|NCT01346592|O2|Outcome|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814236|NCT01346592|O1|Outcome|aTIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses (Day 1 & 29) while subjects aged ≥36 months received one dose (at Day 1) of the vaccine
814237|NCT01346592|E3|Reported Event|Comparator TIV (6 to <72 Months)|Subjects received a licensed comparator trivalent split influenza vaccine (comparator TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814238|NCT01346592|E2|Reported Event|TIV (6 to <72 Months)|Subjects received an investigational trivalent split influenza vaccine (TIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814239|NCT01346592|E1|Reported Event|ATIV (6 to <72 Months)|Subjects received an investigational MF59-adjuvanted trivalent influenza vaccine (aTIV), subjects aged between 6 to <36 months received two doses of 0.25 mL each, while subjects aged ≥36 months received two doses of 0.5 mL each, at Days 1 & 29
814240|NCT01346514|B3|Baseline|Total|Total of all reporting groups
814241|NCT01346514|B2|Baseline|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
814242|NCT01346514|B1|Baseline|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
814243|NCT01346514|P2|Participant Flow|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
814244|NCT01346514|P1|Participant Flow|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
814245|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
814246|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
814247|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
814248|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
814249|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
814264|NCT01346501|P2|Participant Flow|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814265|NCT01346501|P1|Participant Flow|Adalimumab|Participants with Rheumatoid Arthritis (RA) who continued adalimumab treatment after completion of study M06-859 (HOPEFUL I study; NCT00870467), participated in the observational period of studies P12-069 (HOPEFUL II study; NCT01163292) and P12-707 (HOPEFUL III study; NCT01346501).
817677|NCT01335230|O3|Outcome|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
814250|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
814251|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
814273|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814252|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
814253|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
814254|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
814255|NCT01346514|O2|Outcome|Arm 2: Housing Support Group(HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
814256|NCT01346514|O1|Outcome|Arm 1: Addiction/Housing Case Management(AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
814257|NCT01346514|O2|Outcome|Arm 2/Housing Support Group (HSG)|The HSG condition involved a weekly drop-in housing support group. The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
814258|NCT01346514|O1|Outcome|Arm 1/Addiction Housing Case Management (AHCM)|The AHCM condition provided individual case management, delivered at the VA and in the community, designed to assist homeless Veterans with SUD issues. Case management focused on : 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
814259|NCT01346514|E2|Reported Event|Arm 2/Housing Support Group (HSG)|HSG/ The Housing Support Group is a time and attention control. Veterans assigned to HSG attend a weekly drop-in housing group where housing options are discussed and participants receive support from one another.
814260|NCT01346514|E1|Reported Event|Arm 1/Addiction Housing Case Management (AHCM)|AHCM intervention/ AHCM involves intensive case management for housing, substance use, and related issues. Veterans assigned to the AHCM condition will have a case manager who is integrated with the interdisciplinary treatment team. The AHCM will meet with the Veteran weekly, assist the Veteran with potential housing options, support the Veteran in continuing addiction treatment and psychiatric care, visit the Veteran in the community when appropriate, and obtain point of care urine toxicology testing to assess abstinence with the goal of addressing substance use issues proactively. The AHCM will educate the Veteran on needed basic life skills using existing manuals
814261|NCT01346501|B3|Baseline|Total|Total of all reporting groups
814262|NCT01346501|B2|Baseline|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814263|NCT01346501|B1|Baseline|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814267|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814268|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814269|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814270|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814271|NCT01346501|O1|Outcome|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814272|NCT01346501|O2|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707.
814274|NCT01346501|O1|Outcome|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and sustained low disease activity (defined as DAS28-CRP score <3.2 at Week 46 and Week 52), participated in the observational period of studies P12-069 and P12-707.
814275|NCT01346501|E2|Reported Event|Non-adalimumab|Participants with RA who discontinued adalimumab treatment after completion of study M06-859 and re-started adalimumab treatment during the observational period of studies P12-069 and P12-707
814276|NCT01346501|E1|Reported Event|Adalimumab|Participants with RA who continued adalimumab treatment after completion of study M06-859, participated in the observational period of studies P12-069 and P12-707
814277|NCT01346488|B1|Baseline|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814278|NCT01346488|P1|Participant Flow|Participants Receiving Adalimumab|Participants with rheumatoid arthritis (RA) treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814279|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814280|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814281|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814282|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814283|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814284|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814285|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814286|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814287|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814288|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814289|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814290|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
815391|NCT01342549|P2|Participant Flow|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
814291|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814292|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814293|NCT01346488|O1|Outcome|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814294|NCT01346488|E1|Reported Event|Participants Receiving Adalimumab|Participants with RA treated with adalimumab who are either engaged in paid work for more than 35 hours per week (paid workers) or those who are either engaged in paid work for less than 35 hours per week or who perform basic activities of daily life other than paid work (home workers).
814295|NCT01346475|B3|Baseline|Total|Total of all reporting groups
814299|NCT01346475|P1|Participant Flow|Standard-dose Valacyclovir First Then High-dose Valacyclovir|Standard-dose valacyclovir (500 mg daily) for 5 weeks followed by 1 week wash-out and then high-dose valacyclovir (1 gram three times daily) for 5 weeks
814300|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
814301|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
814302|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
814303|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
814304|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
814305|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
814306|NCT01346475|O2|Outcome|High-dose Valacyclovir (1 gm Three Times Daily)|
814307|NCT01346475|O1|Outcome|Standard-dose Valacyclovir (500 mg Daily)|
814308|NCT01346475|E2|Reported Event|High Dose Valacyclovir|
814309|NCT01346475|E1|Reported Event|Valacyclovir|
814310|NCT01346397|B3|Baseline|Total|Total of all reporting groups
814311|NCT01346397|B2|Baseline|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
814312|NCT01346397|B1|Baseline|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
814313|NCT01346397|P2|Participant Flow|Tacrolimus Group|tacrolimus group - after Campath induction tacrolimus will be administered
814314|NCT01346397|P1|Participant Flow|Cyclosporine Group|cyclosporine group - after Campath induction cyclosporine will be administered
814315|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
814316|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
814317|NCT01346397|O2|Outcome|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
814318|NCT01346397|O1|Outcome|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
814319|NCT01346397|E2|Reported Event|Tacrolimus Group|"tacrolimus group - after alemtuzumab induction tacrolimus was administered~cyclosporine or tacrolimus: after alemtuzumab, cyclosporine or tacrolimus was administered"
814320|NCT01346397|E1|Reported Event|Cyclosporine Group|cyclosporine group - after alemtuzumab induction cyclosporine was administered
814321|NCT01346293|B3|Baseline|Total|Total of all reporting groups
814322|NCT01346293|B2|Baseline|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814323|NCT01346293|B1|Baseline|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814324|NCT01346293|P2|Participant Flow|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814325|NCT01346293|P1|Participant Flow|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814326|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814327|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814328|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814329|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814330|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814331|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814332|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814333|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814334|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814335|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814336|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814337|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814338|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814339|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814526|NCT01345630|B3|Baseline|Total|Total of all reporting groups
814341|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814342|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814343|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814344|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814345|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814346|NCT01346293|O2|Outcome|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814347|NCT01346293|O1|Outcome|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4 dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814348|NCT01346293|E2|Reported Event|DAPTACEL®+IPOL®|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DAPTACEL®+IPOL®
814349|NCT01346293|E1|Reported Event|DTaP-IPV|Children ≥4 to <7 years of age, who had been previously vaccinated with a 4-dose series of DAPTACEL and/or Pentacel vaccines only, received a single dose of DTaP-IPV intramuscularly
814350|NCT01346176|B4|Baseline|Total|Total of all reporting groups
814351|NCT01346176|B3|Baseline|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
814352|NCT01346176|B2|Baseline|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
814353|NCT01346176|B1|Baseline|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
814354|NCT01346176|P3|Participant Flow|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
814355|NCT01346176|P2|Participant Flow|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
814356|NCT01346176|P1|Participant Flow|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
814357|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
814358|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
814359|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
814360|NCT01346176|O3|Outcome|Forced Choice|Patients in this arm will receive AD forms in which they must actively choose whether to receive each intervention.
814361|NCT01346176|O2|Outcome|Negative Default|Patients in this arm will receive AD forms where specific life-extending interventions will not be provided unless patients specifically opt-into such selections
814362|NCT01346176|O1|Outcome|Positive Default|Patients in this arm will receive AD forms where specific life-extending interventions will be provided unless patients specifically opt-out from such selections
814363|NCT01346176|E3|Reported Event|Positive Default|
814364|NCT01346176|E2|Reported Event|Negative Default|
814365|NCT01346176|E1|Reported Event|Forced Choice|
814392|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
815165|NCT01343251|P1|Participant Flow|HeRO Graft|patients who are evaluated and receive a Hemodialysis Reliable Outflow (HeRO) graft implant for hemodialysis
814366|NCT01346085|B1|Baseline|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
814367|NCT01346085|P1|Participant Flow|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
814368|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
814403|NCT01345929|O1|Outcome|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
814404|NCT01345929|E2|Reported Event|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
814369|NCT01346085|O1|Outcome|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
814370|NCT01346085|E1|Reported Event|CNI-free Single-group|CNI free immunosuppression: Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
814371|NCT01346072|B3|Baseline|Total|Total of all reporting groups
814372|NCT01346072|B2|Baseline|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
814373|NCT01346072|B1|Baseline|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
814374|NCT01346072|P2|Participant Flow|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
814375|NCT01346072|P1|Participant Flow|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
814376|NCT01346072|O2|Outcome|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
814377|NCT01346072|O1|Outcome|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
814378|NCT01346072|O2|Outcome|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
814379|NCT01346072|O1|Outcome|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
814380|NCT01346072|E2|Reported Event|Tolvaptan Low Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~Low Copeptin < 10 pmol/L at baseline"
814381|NCT01346072|E1|Reported Event|Tolvaptan High Copeptin|"Tolvaptan: oral, 30 mg, single dose, one time administration~High Copeptin ≥ 10 pmol/L at baseline"
814382|NCT01346059|B3|Baseline|Total|Total of all reporting groups
814383|NCT01346059|B2|Baseline|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
814384|NCT01346059|B1|Baseline|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
814385|NCT01346059|P2|Participant Flow|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
814386|NCT01346059|P1|Participant Flow|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
814387|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
814388|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
814389|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
814390|NCT01346059|O1|Outcome|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
814391|NCT01346059|O2|Outcome|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
814393|NCT01346059|E2|Reported Event|Vancomycin|"The vancomycin arm will receive vancomycin solution through the catheter.~Vancomycin: Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline."
814394|NCT01346059|E1|Reported Event|Saline|"The saline arm will receive normal saline through the catheter as a placebo.~Saline: Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used."
814395|NCT01345929|B3|Baseline|Total|Total of all reporting groups
814396|NCT01345929|B2|Baseline|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
814397|NCT01345929|B1|Baseline|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days"
814398|NCT01345929|P2|Participant Flow|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days~Of the 1083 subjects in the integrated analysis set, 535 received levofloxacin."
814399|NCT01345929|P1|Participant Flow|CXA-201 as Treatment for cUTI|"CXA-201 IV infusion (1500mg q8) for 7 days~CXA-201: CXA-201 IV infusion (1500mg q8) for 7 days~Of the 1083 subjects in the integrated analysis set, 533 received CXA."
814400|NCT01345929|O2|Outcome|Levofloxacin as Treatment for cUTI|"Levofloxacin IV infusion (750mg qd) for 7 days~Levofloxacin: Levofloxacin IV infusion (750mg qd) for 7 days"
814407|NCT01345786|B4|Baseline|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
814408|NCT01345786|B3|Baseline|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
814409|NCT01345786|B2|Baseline|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
814410|NCT01345786|B1|Baseline|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
814411|NCT01345786|P4|Participant Flow|Part 2 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
814412|NCT01345786|P3|Participant Flow|Part 2 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B) on the first day of Period 2 and Period 4. Participants in Part 2 were from Site 2."
814413|NCT01345786|P2|Participant Flow|Part 1 - Sequence 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
814414|NCT01345786|P1|Participant Flow|Part 1 - Sequence 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2) on the first day of Period 1 and Period 3; Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A) on the first day of Period 2 and Period 4. Participants in Part 1 were from Site 1."
814415|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814416|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814548|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814417|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814418|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814419|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814420|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814421|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814422|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814592|NCT01345591|O1|Outcome|Fat Graft Volume at 3 Months|fat grafting for facial trauma, volume measured at 3 months post-op
814423|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814424|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814425|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814426|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814427|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814428|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814429|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814430|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814431|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814432|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814433|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814474|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
814434|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814435|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814436|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814437|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814438|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814439|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814440|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814441|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814442|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814443|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814444|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814445|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814446|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814447|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814448|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814449|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814450|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814475|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
814451|NCT01345786|O4|Outcome|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814452|NCT01345786|O3|Outcome|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814453|NCT01345786|O2|Outcome|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814454|NCT01345786|O1|Outcome|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814455|NCT01345786|E4|Reported Event|Phase 3 NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch B), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814456|NCT01345786|E3|Reported Event|Commercial NOMAC-E2, Part 2|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 2 were from Site 2."
814457|NCT01345786|E2|Reported Event|Phase 3 NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination tablet (2.5 mg NOMAC/1.5 mg E2) from the Phase 3 clinical trial program (Batch A), either on the first day of Period 2 and Period 4 (for participants randomized to Sequence 1) or on the first day of Period 1 and Period 3 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814458|NCT01345786|E1|Reported Event|Commercial NOMAC-E2, Part 1|"Participants received a single oral dose of the NOMAC-E2 fixed-dose combination commercial tablet (2.5 mg NOMAC/1.5 mg E2), either on the first day of Period 1 and Period 3 (for participants randomized to Sequence 1) or on the first day of Period 2 and Period 4 (for participants randomized to Sequence 2). Participants in Part 1 were from Site 1."
814459|NCT01345721|B4|Baseline|Total|Total of all reporting groups
814460|NCT01345721|B3|Baseline|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814461|NCT01345721|B2|Baseline|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814462|NCT01345721|B1|Baseline|MenACWY (2 Primary +1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814463|NCT01345721|P3|Participant Flow|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814464|NCT01345721|P2|Participant Flow|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814465|NCT01345721|P1|Participant Flow|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814466|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814467|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814468|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814469|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814470|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814471|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814472|NCT01345721|O2|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study
814473|NCT01345721|O1|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study
814476|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814477|NCT01345721|O1|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814478|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814479|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814480|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814481|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814482|NCT01345721|O3|Outcome|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814483|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814484|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814485|NCT01345721|O3|Outcome|MenC (1 Primary Dose) +MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814486|NCT01345721|O2|Outcome|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814487|NCT01345721|O1|Outcome|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814488|NCT01345721|E3|Reported Event|MenC (1 Primary Dose) + MenACWY (1 Booster Dose)|Subjects, who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.
814489|NCT01345721|E2|Reported Event|MenACWY (1 Primary + 1 Booster Dose)|Subjects, who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814490|NCT01345721|E1|Reported Event|MenACWY (2 Primary + 1 Booster Dose)|Subjects, who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.
814491|NCT01345682|B3|Baseline|Total|Total of all reporting groups
814492|NCT01345682|B2|Baseline|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814493|NCT01345682|B1|Baseline|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814494|NCT01345682|P2|Participant Flow|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814495|NCT01345682|P1|Participant Flow|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814496|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814497|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814498|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814499|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
815166|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
814500|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814501|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814502|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814503|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814504|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814505|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814527|NCT01345630|B2|Baseline|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814506|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814507|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814508|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814509|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814510|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814511|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814512|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814513|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814514|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814515|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814516|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814517|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814518|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814519|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814520|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814521|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814522|NCT01345682|O2|Outcome|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814523|NCT01345682|O1|Outcome|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814524|NCT01345682|E2|Reported Event|Methotrexate|Intravenous bolus injection of Methotrexate Starting dose 40 mg/m² weekly; escalation to 50 mg/m² and / or dose reduction to 40 mg/m² (if applicable), 30 mg/m², and 20 mg/m² (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814525|NCT01345682|E1|Reported Event|Afatinib (BIBW 2992)|Oral administration of Afatinib (film-coated tablets). Starting dose 40 mg once daily; escalation to 50 mg/day and / or dose reduction to 40 mg/day (if applicable), 30 mg/day, or 20 mg/day (according to the protocol-defined dose escalation and dose reduction scheme) if required. No dose increase was allowed after a dose reduction.
814528|NCT01345630|B1|Baseline|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814529|NCT01345630|P2|Participant Flow|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814530|NCT01345630|P1|Participant Flow|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814531|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814532|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814533|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814534|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814535|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814536|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814537|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814538|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814539|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814540|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814541|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814542|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814543|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814544|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814545|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814546|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814547|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814549|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814550|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814551|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814552|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814553|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814554|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814555|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814556|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814557|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814558|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814590|NCT01345591|O1|Outcome|Fat Grafting_evaluation at Baseline|quality of life measurement at baseline to include SWAP, COPE and CSQ-8 questionnaires
814559|NCT01345630|O4|Outcome|FTC/TDF+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
814560|NCT01345630|O3|Outcome|FTC/TDF+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily. Summary of tropism results by baseline.
814561|NCT01345630|O2|Outcome|MVC+DRV/r - Failure|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results corresponding to timepoint at or after PDTF.
814562|NCT01345630|O1|Outcome|MVC+DRV/r - Baseline|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily. Summary of tropism results by baseline.
814563|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814564|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814565|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814566|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814567|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814568|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814569|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814570|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814571|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814572|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814573|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814574|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814575|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814576|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814577|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
815167|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
815168|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO Graft
814578|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814579|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814580|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814581|NCT01345630|O2|Outcome|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814582|NCT01345630|O1|Outcome|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814583|NCT01345630|E2|Reported Event|FTC/TDF+DRV/r|Participants infected with R5 HIV-1 received oral tablets of emtricitabine/tenofovir 200/300 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for maraviroc once daily.
814584|NCT01345630|E1|Reported Event|MVC+DRV/r|Participants infected with R5 HIV-1 received oral tablets of Maraviroc 150 mg once daily plus darunavir/ritonavir 800/100 mg once daily plus placebo for emtricitabine/tenofovir once daily.
814585|NCT01345591|B1|Baseline|Fat Grafting|Fat Grafting for facial trauma
814586|NCT01345591|P1|Participant Flow|Fat Grafting|fat grafting for facial trauma
814587|NCT01345591|O4|Outcome|Fat Grafting_9 Months Post-op|quality of life measurement at 9 months post-op to include SWAP, COPE and CSQ-8 questionnaires
814588|NCT01345591|O3|Outcome|Fat Grafting_3 Months Post op|quality of life measurement at 3 months post-op to include SWAP, COPE and CSQ-8 questionnaires
814589|NCT01345591|O2|Outcome|Fat Grafting_7-21 Days Post op|quality of life measurement at 7-21 days post-op to include SWAP, COPE and CSQ-8 questionnaires
814594|NCT01345318|B1|Baseline|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
814595|NCT01345318|P1|Participant Flow|PF-04236921|All participants entering this study were given a 50 mg subcutaneous (SC) dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
814596|NCT01345318|O1|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
814597|NCT01345318|O1|Outcome|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
814598|NCT01345318|E1|Reported Event|PF-04236921|All participants entering this study were given a 50 mg SC dose of PF-04236921 at baseline and then every 8 weeks through Week 40. The participants were on active treatment through Week 48. A one-time dose escalation to 100 mg was allowed, if participants experienced a clinical deterioration or unacceptably low level of response to study drug. Dose escalation was not allowed before Week 8.
814599|NCT01345292|B4|Baseline|Total|Total of all reporting groups
814600|NCT01345292|B3|Baseline|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814601|NCT01345292|B2|Baseline|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814602|NCT01345292|B1|Baseline|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814603|NCT01345292|P3|Participant Flow|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814604|NCT01345292|P2|Participant Flow|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814605|NCT01345292|P1|Participant Flow|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814606|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814607|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814608|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814609|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814610|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814611|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
815169|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
815170|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive a HeRO
814612|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814613|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814614|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814615|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814616|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814617|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814618|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814619|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814620|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814621|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814622|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814623|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814624|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814625|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814626|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814627|NCT01345292|O3|Outcome|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
815433|NCT01342523|P29|Participant Flow|No CIS/Loz/Emails/Full Website/Full Booklet|
814628|NCT01345292|O2|Outcome|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814629|NCT01345292|O1|Outcome|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814630|NCT01345292|E3|Reported Event|12027-027 (1.40% Potassium Oxalate Mouth Rinse)|Crest® Cavity Protection Regular Toothpaste followed by Investigative 1.40% Potassium Oxalate Mouth Rinse (Brushing followed by Mouth Rinse)
814631|NCT01345292|E2|Reported Event|Positive Control (Sensodyne Toothpaste)|Sensodyne® Original Toothpaste (Brushing Only)
814632|NCT01345292|E1|Reported Event|Negative Control (Crest Regular Toothpaste)|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
814633|NCT01345253|B3|Baseline|Total|Total of all reporting groups
814634|NCT01345253|B2|Baseline|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814635|NCT01345253|B1|Baseline|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814636|NCT01345253|P2|Participant Flow|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814637|NCT01345253|P1|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814638|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814639|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814640|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814641|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814642|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814643|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814644|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814645|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814646|NCT01345253|O2|Outcome|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814647|NCT01345253|O1|Outcome|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814648|NCT01345253|E2|Reported Event|Belimumab 10 mg/kg|Participants received belimumab 10 miligrams (mg)/kilogram (kg) IV on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814649|NCT01345253|E1|Reported Event|Placebo|Participants received placebo intravenously (IV) on Day 0, Day 14, Day 28 and then every 28 days until Week 48 of the blinded period.
814650|NCT01345240|B6|Baseline|Total|Total of all reporting groups
814770|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
815171|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
814651|NCT01345240|B5|Baseline|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814652|NCT01345240|B4|Baseline|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814653|NCT01345240|B3|Baseline|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814654|NCT01345240|B2|Baseline|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814655|NCT01345240|B1|Baseline|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814656|NCT01345240|P5|Participant Flow|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814657|NCT01345240|P4|Participant Flow|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814771|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
814772|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
814773|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
814658|NCT01345240|P3|Participant Flow|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814659|NCT01345240|P2|Participant Flow|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814795|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814796|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814797|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814660|NCT01345240|P1|Participant Flow|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814661|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814662|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814663|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814664|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814774|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
814775|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
815172|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
815173|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft recipients
814665|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814666|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814912|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814667|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814668|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814669|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814670|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814671|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814776|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
814777|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
814778|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
814672|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814673|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814674|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814675|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814676|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814677|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814678|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814779|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
814780|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
814781|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receiving a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
814679|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814687|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814680|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814681|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814682|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814683|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814684|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814685|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814782|NCT01345123|O1|Outcome|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
814783|NCT01345123|E3|Reported Event|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
815174|NCT01343251|O2|Outcome|Control|HeRO eligible patients who did not receive HeRO
815175|NCT01343251|O1|Outcome|HeRO Graft|HeRO Graft Recipients
814686|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814688|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814689|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814690|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814691|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814692|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814784|NCT01345123|E2|Reported Event|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
814785|NCT01345123|E1|Reported Event|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
814786|NCT01345058|B3|Baseline|Total|Total of all reporting groups
815176|NCT01343251|E2|Reported Event|Control|HeRO eligible patients who did not receive a HeRO Graft
814693|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814739|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814694|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814695|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814696|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814697|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814698|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814699|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814787|NCT01345058|B2|Baseline|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814788|NCT01345058|B1|Baseline|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814700|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814701|NCT01345240|O2|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814702|NCT01345240|O1|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814703|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814704|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814705|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814706|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814707|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
815177|NCT01343251|E1|Reported Event|HeRO Graft|HeRO Graft recipients
814708|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814709|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814710|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814711|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814712|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814713|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814714|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814738|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814715|NCT01345240|O2|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814913|NCT01344460|O2|Outcome|Unenhanced MRA|
814716|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814717|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814718|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814719|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814720|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814721|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814722|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814764|NCT01345123|B1|Baseline|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
814723|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814724|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814725|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814726|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814727|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814728|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814729|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814765|NCT01345123|P3|Participant Flow|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
814766|NCT01345123|P2|Participant Flow|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
814767|NCT01345123|P1|Participant Flow|Decision Aid With Health Coaching|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you) and a call from a nurse health coach.
814789|NCT01345058|P2|Participant Flow|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814790|NCT01345058|P1|Participant Flow|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814791|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814730|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814731|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814732|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814733|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814734|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814735|NCT01345240|O2|Outcome|RTS,S Lot 2 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 2 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814736|NCT01345240|O1|Outcome|RTS,S Lot 1 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 1 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regiment received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814737|NCT01345240|O3|Outcome|RTS,S Lot 3 Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in its Lot 3 formulation only, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814768|NCT01345123|O3|Outcome|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
814889|NCT01344538|O2|Outcome|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
814740|NCT01345240|O5|Outcome|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814741|NCT01345240|O4|Outcome|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814742|NCT01345240|O3|Outcome|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814743|NCT01345240|O2|Outcome|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814744|NCT01345240|O1|Outcome|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814745|NCT01345240|O2|Outcome|Engerix B Group|Subjects in this group were subjects from the Engerix B Regimen A and Engerix B Regimen B groups were administered Engerix B™ as a 3-dose primary vaccination course, at Weeks 0, 4 and 8, followed by a booster dose, at Month 50. Subjects in this group were also administered, according to varied schedules, depending on the vaccination regimen they were allocated too in their respective group, doses Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™ and of vaccines against yellow fever and against measles. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814746|NCT01345240|O1|Outcome|RTS,S Group|Subjects in this group were subjects from the RTS,S Regimen A, RTS,S Regimen B, and RTS,S Regimen C groups who were administered a 3-dose primary vaccination course of the RTS,S vaccine in any of its formulations, Lot 1, 2 or 3, at Weeks 0, 4 and 8. Subjects in this group were also administered, according to varied schedules depending on the RTS,S vaccination regimen received, doses of Infanrix™-Hib, Polio Sabin™, Rotarix™, Synflorix™, Rotarix™, Engerix B™ and vaccines against yellow fever and against measles. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814890|NCT01344538|O1|Outcome|Lactose Capsule|Placebo Capsule : 2.0 g per day
814792|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814793|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814794|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814747|NCT01345240|E5|Reported Event|Engerix B Regimen B Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen B. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™ vaccine, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814748|NCT01345240|E4|Reported Event|Engerix B Regimen A Group|Subjects, healthy male and female infants between 8 and 12 weeks of age inclusive at the time of first vaccination, received the Engerix-B Vaccination Regimen A. This regimen included 3 doses of Engerix B™ co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™ at Weeks 0, 4 and 8, and 2 doses of Rotarix™, at Weeks 6 and 10. Additionally, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. Engerix B™ was administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814749|NCT01345240|E3|Reported Event|RTS,S Regimen C Group|This group results from the pooling of the RTS,S Regimen C Lot 1, RTS,S Regimen C Lot 2 and RTS,S Regimen C Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 6 and 10, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814750|NCT01345240|E2|Reported Event|RTS,S Regimen B Group|This group results from the pooling of the RTS,S Regimen B Lot 1, RTS,S Regimen B Lot 2 and RTS,S Regimen B Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib and Polio Sabin™, at Weeks 0, 4 and 8, 2 doses of Rotarix™, at Weeks 4 and 8, and 3 doses of Synflorix™ at Weeks 2, 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814751|NCT01345240|E1|Reported Event|RTS,S Regimen A Group|This group results from the pooling of the RTS,S Regimen A Lot 1, RTS,S Regimen A Lot 2 and RTS,S Regimen A Lot 3 groups. Subjects, healthy male and female infants aged between 8 and 12 weeks inclusive at the time of first vaccination, received 3 doses of RTS,S vaccine, Lot 1, 2 or 3, co-administered with Infanrix™-Hib, Polio Sabin™ and Synflorix™, at Weeks 0, 4 and 8, and 2 doses of Rotarix™ vaccine, at Weeks 6 and 10. In addition, subjects also received one dose of vaccine against yellow fever and against measles, at Week 32, and one booster dose of Infanrix™-Hib and Synflorix™, at Month 16, and one booster dose of Engerix B™ vaccine, at Month 50. The RTS,S vaccine and Engerix B™ were administered intramuscularly (IM) in the left anterolateral thigh, Infanrix™-Hib IM in the right deltoid, Synflorix™ IM in the right anterolateral thigh, and Rotarix™ and Polio Sabin™ orally. The measles and yellow fever vaccines were administered IM in the deltoid.
814752|NCT01345162|B3|Baseline|Total|Total of all reporting groups
814753|NCT01345162|B2|Baseline|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814754|NCT01345162|B1|Baseline|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814755|NCT01345162|P2|Participant Flow|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814756|NCT01345162|P1|Participant Flow|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814757|NCT01345162|O2|Outcome|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814758|NCT01345162|O1|Outcome|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814759|NCT01345162|E2|Reported Event|Acetaminophene + Tramadol|"acetaminophene 325mg+tramadol 37,5mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814760|NCT01345162|E1|Reported Event|Ketorolac|"Ketorolac 10mg~1cp x 3/die~postoperative analgesic treatment: 1. Ketorolac 10mg 1cp x 3/die 2. Acetaminophene 325mg+Tramadol 37,5mg 1cp x 3/die"
814761|NCT01345123|B4|Baseline|Total|Total of all reporting groups
814762|NCT01345123|B3|Baseline|No Condition Specific Support|Study participants do not receive outreach on knee, hip or herniated disc condition.
814763|NCT01345123|B2|Baseline|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
814769|NCT01345123|O2|Outcome|Decision Aid Only|Study participants receive a digital video disc and booklet (Treatment Choices for Knee Osteoarthritis, Treatment Choices for Hip Osteoarthritis, or Herniated Disc Choosing the right treatment for you).
814798|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814799|NCT01345058|O2|Outcome|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814800|NCT01345058|O1|Outcome|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814801|NCT01345058|E2|Reported Event|Control Group (High-Dose Levetiracetam)|Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam >1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study.
814802|NCT01345058|E1|Reported Event|Lacosamide + Low-Dose Levetiracetam|Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam.
814803|NCT01344876|B1|Baseline|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
814804|NCT01344876|P5|Participant Flow|OPB-51602: 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814805|NCT01344876|P4|Participant Flow|OPB-51602: 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814806|NCT01344876|P3|Participant Flow|OPB-51602: 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814807|NCT01344876|P2|Participant Flow|OPB-51602: 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814808|NCT01344876|P1|Participant Flow|OPB-51602: 1mg/Day|OPB-51602: 1, 2, 3,4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814809|NCT01344876|O5|Outcome|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814810|NCT01344876|O4|Outcome|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814811|NCT01344876|O3|Outcome|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814812|NCT01344876|O2|Outcome|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814813|NCT01344876|O1|Outcome|OPB-51602 1m/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814814|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
814815|NCT01344876|O1|Outcome|OPB-51602|"OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle~OPB-51602: once daily during the treatment period"
814816|NCT01344876|E5|Reported Event|OPB-51602 6mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814817|NCT01344876|E4|Reported Event|OPB-51602 4mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814818|NCT01344876|E3|Reported Event|OPB-51602 3mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814819|NCT01344876|E2|Reported Event|OPB-51602 2mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814820|NCT01344876|E1|Reported Event|OPB-51602 1mg/Day|OPB-51602: 1, 2, 3, 4 and 6 mg/day oral once daily (QD) in a 4 week cycle
814821|NCT01344759|B3|Baseline|Total|Total of all reporting groups
814822|NCT01344759|B2|Baseline|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
814823|NCT01344759|B1|Baseline|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
814824|NCT01344759|P2|Participant Flow|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
814825|NCT01344759|P1|Participant Flow|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
814826|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814827|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814828|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814829|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814830|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814831|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814832|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814833|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814834|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814835|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814836|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814837|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814838|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814839|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814840|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814841|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814842|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814843|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814844|NCT01344759|O6|Outcome|Severe OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814845|NCT01344759|O5|Outcome|Severe OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814891|NCT01344538|E2|Reported Event|Lactose Capsule|Placebo Capsule: 2.0 g per day
814892|NCT01344538|E1|Reported Event|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations): 2.0 g per day (10:1 extract)
814846|NCT01344759|O4|Outcome|Moderate OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814847|NCT01344759|O3|Outcome|Moderate OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814848|NCT01344759|O2|Outcome|Mild OSA and Propofol|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive Propofol."
814849|NCT01344759|O1|Outcome|Mild OSA and Dexmedetomidine|"Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10)~Additionally this patient was assigned to receive DEX."
814850|NCT01344759|O2|Outcome|Dexmedetomidine|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump (low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of DEX 0.5 mcg/kg will be given over 3 minutes and infusion rate will be increased to 1.5 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a 2 mcg/kg bolus of DEX will be given over 10 minutes followed by an increase in the infusion rate to 3 mcg/kg/hr (high dose)."
814914|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814915|NCT01344460|O2|Outcome|Unenhanced MRA|
814916|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814917|NCT01344460|O2|Outcome|Unenhanced MRA|
814918|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814919|NCT01344460|O2|Outcome|Unenhanced MRA|
814920|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814851|NCT01344759|O1|Outcome|Propofol|"Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump (Low dose). Baseline airway images are obtained during this time.~If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team.~After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose)."
814852|NCT01344759|E2|Reported Event|Dexmedetomidine|Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
814853|NCT01344759|E1|Reported Event|Propofol|Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
814854|NCT01344629|B3|Baseline|Total|Total of all reporting groups
814855|NCT01344629|B2|Baseline|Treatment Sequence B|
814856|NCT01344629|B1|Baseline|Treatment Sequence A|
814857|NCT01344629|P2|Participant Flow|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
814858|NCT01344629|P1|Participant Flow|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
814859|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
814860|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
814861|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
814862|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
814863|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
814864|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
814865|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
814866|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
814867|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
814868|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
814869|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
814870|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
814871|NCT01344629|O2|Outcome|T80mg Tablet and A5 mg Tablet in Concomitant Use|
814872|NCT01344629|O1|Outcome|T80/A5 mg FDC Tablet|
814873|NCT01344629|E2|Reported Event|Treatment Sequence B|Concomitant use, T80/A 5mg FDC tablet, T80/A 5mg FDC tablet, Concomitant use
814874|NCT01344629|E1|Reported Event|Treatment Sequence A|T80/A 5mg FDC tablet, Concomitant use, Concomitant use, T80/A 5mg FDC tablet
814875|NCT01344616|B3|Baseline|Total|Total of all reporting groups
814876|NCT01344616|B2|Baseline|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
814877|NCT01344616|B1|Baseline|Usual Clinical Care|usual clinical care with no intervention
814878|NCT01344616|P2|Participant Flow|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
814879|NCT01344616|P1|Participant Flow|Usual Clinical Care|usual clinical care with no intervention
814880|NCT01344616|O2|Outcome|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
814881|NCT01344616|O1|Outcome|Usual Clinical Care|usual clinical care with no intervention
814882|NCT01344616|E2|Reported Event|Lifestyle Counseling|"computer-based clinical support to patient~lifestyle support: computer-based lifestyle improvement support and clinician support"
814883|NCT01344616|E1|Reported Event|Usual Clinical Care|usual clinical care with no intervention
814884|NCT01344538|B3|Baseline|Total|Total of all reporting groups
814885|NCT01344538|B2|Baseline|Lactose Capsule|Placebo Capsule : 2.0 g per day
814886|NCT01344538|B1|Baseline|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
814887|NCT01344538|P2|Participant Flow|Lactose Capsule|Placebo Capsule : 2.0 g per day
814888|NCT01344538|P1|Participant Flow|Ginger Root Extract|Ginger Root Extract (Pure Encapsulations) : 2.0 g per day (10:1 extract)
814893|NCT01344460|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
814894|NCT01344460|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
814895|NCT01344460|O2|Outcome|Unenhanced MRA|
814896|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814897|NCT01344460|O2|Outcome|Unenhanced MRA|
814898|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814899|NCT01344460|O2|Outcome|Unenhanced MRA|
814900|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814901|NCT01344460|O2|Outcome|Unenhanced MRA|
814902|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814903|NCT01344460|O2|Outcome|Unenhanced MRA|
814904|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814905|NCT01344460|O2|Outcome|Unenhanced MRA|
814906|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814907|NCT01344460|O2|Outcome|Unenhanced MRA|
814908|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814909|NCT01344460|O2|Outcome|Unenhanced MRA|
814910|NCT01344460|O1|Outcome|Gadobutrol-enhanced MRA|
814911|NCT01344460|O2|Outcome|Unenhanced MRA|
814937|NCT01344460|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 mmol/kg body weight (bw) by single intravenous (i.v.) bolus injection. During the course of the study, non-contrast magnetic resonance angiography (MRA) images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
814938|NCT01344447|B1|Baseline|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
814939|NCT01344447|P1|Participant Flow|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
814940|NCT01344447|O2|Outcome|Unenhanced MRA|
814941|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814942|NCT01344447|O2|Outcome|Unenhanced MRA|
814943|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814944|NCT01344447|O2|Outcome|Unenhanced MRA|
814945|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814946|NCT01344447|O2|Outcome|Unenhanced MRA|
814947|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814948|NCT01344447|O2|Outcome|Unenhanced MRA|
814949|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814950|NCT01344447|O2|Outcome|Unenhanced MRA|
814951|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814952|NCT01344447|O2|Outcome|Unenhanced MRA|
814953|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814954|NCT01344447|O2|Outcome|Unenhanced MRA|
814955|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814956|NCT01344447|O2|Outcome|Unenhanced MRA|
814957|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814958|NCT01344447|O2|Outcome|Unenhanced MRA|
814959|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814960|NCT01344447|O2|Outcome|Unenhanced MRA|
814961|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814962|NCT01344447|O2|Outcome|Unenhanced MRA|
814963|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814964|NCT01344447|O2|Outcome|Unenhanced MRA|
814965|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814966|NCT01344447|O2|Outcome|Unenhanced MRA|
814967|NCT01344447|O1|Outcome|Gadobutrol-enhanced MRA|
814968|NCT01344447|O3|Outcome|Computed Tomographic Angiography|
814979|NCT01344447|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Gadobutrol was administered to all participants receiving study drug at the standard dose of 0.1 millimole per kilogram (mmol/kg) body weight (BW) by single intravenous (IV) bolus injection. During the course of the study, non-contrast MRA images were obtained before the administration of gadobutrol, and gadobutrol-enhanced MRA images were obtained after injection.
814980|NCT01344369|B3|Baseline|Total|Total of all reporting groups
814981|NCT01344369|B2|Baseline|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
814982|NCT01344369|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
814983|NCT01344369|P2|Participant Flow|FEMCON® Fe (Reference) First|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in first period followed by 0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
814984|NCT01344369|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in first period followed by 0.4 mg/0.035 mg FEMCON® Fe Chewable Tablets reference product dosed in the second period.
814985|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
814986|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
814987|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
814988|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
814989|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
814990|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
814991|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
814992|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
814993|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
814994|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
814995|NCT01344369|O2|Outcome|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
814996|NCT01344369|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
814997|NCT01344369|E2|Reported Event|FEMCON® Fe (Reference)|0.4 mg/0.035 mg FEMCON® Fe Chewable tablets reference product dosed in either period.
814998|NCT01344369|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/0.035 mg Norethindrone/Ethinyl Estradiol 0.4 mg/0.035 mg Chewable Tablets test product dosed in either period.
814999|NCT01344161|B3|Baseline|Total|Total of all reporting groups
815000|NCT01344161|B2|Baseline|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
815001|NCT01344161|B1|Baseline|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
815002|NCT01344161|P2|Participant Flow|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
815003|NCT01344161|P1|Participant Flow|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
815004|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
815005|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
815006|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
815007|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
815008|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
815009|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
815010|NCT01344161|O2|Outcome|Placebo|25 microgram lactose
815011|NCT01344161|O1|Outcome|Vitamin D|25 microgram cholecalciferol
815012|NCT01344161|E2|Reported Event|Vitamin D|In vitamin D group women used a pill of 25 microgram cholecalciferol every day for 12-weeks.
815013|NCT01344161|E1|Reported Event|Lactose|In placebo group women used a pill of 25 microgram lactose every day for 12-weeks.
815014|NCT01344057|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
815015|NCT01344057|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
815016|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
815017|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
815018|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
815232|NCT01343004|B1|Baseline|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815019|NCT01344057|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until day 22.
815020|NCT01344057|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of trivalent subunit inactivated adjuvanted influenza vaccine FLUAD during the vaccination visit, according to the study protocol (follow-up period: until day 22).
815021|NCT01343901|B1|Baseline|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815022|NCT01343901|P1|Participant Flow|Bevacizumab|All participants with metastatic colorectal cancer (mCRC) with exclusively liver or liver and lung metastases for whom bevacizumab (Avastin) was administered as part of first line treatment for potentially resectable liver metastases as per treating physician discretion. All concomitant medications as used in daily routine clinical practice were allowed.
815023|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815024|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815025|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815026|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815027|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815028|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815029|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815090|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815030|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815031|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815032|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815033|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815034|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815035|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815036|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815037|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815038|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815039|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815040|NCT01343901|O1|Outcome|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815041|NCT01343901|E1|Reported Event|Bevacizumab|All participants with mCRC with exclusively liver or liver and lung metastases, who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician’s discretion were observed. All concomitant medications as used in routine clinical practice were allowed.
815042|NCT01343888|B4|Baseline|Total|Total of all reporting groups
815043|NCT01343888|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815044|NCT01343888|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815045|NCT01343888|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815046|NCT01343888|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815047|NCT01343888|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24. Patients with ETS stopped all study medication at Week 24; patients without ETS subsequently received PegIFN/RBV alone up to Week 48.
815048|NCT01343888|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral) plus Pegylated Interferon-alpha (PegIFN)/ Ribavirin (RBV) (subcutaneous injection/oral) for 12 or 24 weeks, depending on achievement of early treatment success (ETS). Patients with ETS received this treatment for 12 weeks and subsequently PegIFN/RBV alone up to Week 24; patients without ETS received this treatment for 24 weeks and subsequently PegIFN/RBV alone up to Week 48.
815049|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815050|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815051|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815052|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815053|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815054|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815055|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815056|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815057|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815058|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815059|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815060|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815061|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815062|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815063|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815064|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815065|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815066|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815067|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815068|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815069|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815070|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815071|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815072|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815073|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815074|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815075|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815076|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815077|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815078|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815079|NCT01343888|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815080|NCT01343888|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815081|NCT01343888|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815082|NCT01343888|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily plus PegIFN/RBV (subcutaneous injection/oral) for 24 weeks, followed by PegIFN/RBV alone up to Week 48.
815083|NCT01343888|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 weeks, followed by PegIFN/RBV up to Week 24 or 48.
815084|NCT01343888|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral) plus PegIFN/RBV (subcutaneous injection/oral) for 12 or 24 weeks, followed by PegIFN/RBV alone up to Week 24 or 48.
815085|NCT01342770|B1|Baseline|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815086|NCT01342770|P1|Participant Flow|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815087|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815088|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815089|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815434|NCT01342523|P28|Participant Flow|CIS/Loz/Emails/Lite Website/Full Booklet|
815091|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815092|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815093|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815094|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815095|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815096|NCT01342770|O1|Outcome|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815097|NCT01342770|E1|Reported Event|Treatment (Pioglitazone Hydrochloride)|Patients receive pioglitazone hydrochloride PO QD for 14-42 days. Patients then undergo surgery.
815098|NCT01342757|B1|Baseline|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
815099|NCT01342757|P1|Participant Flow|Vorinostat and Temozolomide|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
815100|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
817678|NCT01335230|O2|Outcome|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
815101|NCT01342757|O1|Outcome|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
815102|NCT01342757|E1|Reported Event|Arm I|"Patients receive vorinostat orally (PO) once daily (QD) on days -7 to -1 (course 1 only) and days 8-14 and 22-28 and temozolomide PO QD on days 1-5. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients previously treated with standard radiotherapy and temozolomide receive maintenance temozolomide PO on days 1-5.~Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicities. Patients undergo magnetic resonance spectroscopy imaging at baseline and at approximately 1 and 8 weeks on treatment. Patients also undergo an Inventory of Depression Symptomatology Self-Reported (IDS-SR) assessment at baseline and periodically during study."
815103|NCT01343823|B5|Baseline|Total|Total of all reporting groups
815104|NCT01343823|B4|Baseline|Placebo|
815105|NCT01343823|B3|Baseline|Ecallantide 60 mg|
815106|NCT01343823|B2|Baseline|Ecallantide 30 mg|
815107|NCT01343823|B1|Baseline|Ecallantide 10 mg|
815108|NCT01343823|P4|Participant Flow|Ecallantide 60mg|60 mg administered as two 30 mg SC injections of ecallantide
815109|NCT01343823|P3|Participant Flow|Ecallantide 30 mg|30 mg administered as one 30 mg SC injection of ecallantide and one matching placebo
815110|NCT01343823|P2|Participant Flow|Ecallantide 10 mg|10 mg administered as one 10 mg SC injection of ecallantide and one matching placebo
815111|NCT01343823|P1|Participant Flow|Placebo|Administered by two subcutaneous injections.
815112|NCT01343823|O4|Outcome|Ecallantide 60 mg|
815113|NCT01343823|O3|Outcome|Ecallantide 30 mg|
815114|NCT01343823|O2|Outcome|Ecallantide 10 mg|
815115|NCT01343823|O1|Outcome|Placebo|
815116|NCT01343823|O4|Outcome|Ecallantide 60 mg|
815117|NCT01343823|O3|Outcome|Ecallantide 30 mg|
815118|NCT01343823|O2|Outcome|Ecallantide 10 mg|
815119|NCT01343823|O1|Outcome|Placebo|
815120|NCT01343823|E4|Reported Event|Placebo|
815121|NCT01343823|E3|Reported Event|Ecallantide 60 mg|
815122|NCT01343823|E2|Reported Event|Ecallantide 30 mg|
815123|NCT01343823|E1|Reported Event|Ecallantide 10 mg|
815124|NCT01343667|B3|Baseline|Total|Total of all reporting groups
815125|NCT01343667|B2|Baseline|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
815126|NCT01343667|B1|Baseline|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
815348|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815127|NCT01343667|P2|Participant Flow|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
815128|NCT01343667|P1|Participant Flow|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
815129|NCT01343667|O2|Outcome|GEF EPD|"Carotid artery stenting with Gore Embolic Filter embolic protection device~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
815130|NCT01343667|O1|Outcome|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System embolic protection device~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
815131|NCT01343667|E2|Reported Event|GEF EPD|"Carotid artery stenting with Gore Embolic Filter~Gore Embolic Filter: Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting"
815132|NCT01343667|E1|Reported Event|GFRS EPD|"Carotid artery stenting with Gore Flow Reversal System~Gore Flow Reversal System: Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting"
815133|NCT01343485|B3|Baseline|Total|Total of all reporting groups
815134|NCT01343485|B2|Baseline|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
815135|NCT01343485|B1|Baseline|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
815136|NCT01343485|P2|Participant Flow|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
815137|NCT01343485|P1|Participant Flow|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
815138|NCT01343485|O2|Outcome|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
815139|NCT01343485|O1|Outcome|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
817679|NCT01335230|O1|Outcome|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
815140|NCT01343485|E2|Reported Event|Intervention, Computer Reminder System|"Study participants in the intervention sites will receive standard care for HPV vaccine administration per PPFA protocol, reminder messages for subsequent vaccination appointments, and real-time determination of financial assistance for HPV vaccine.~Computer reminder system : Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series"
815141|NCT01343485|E1|Reported Event|Control, Standard Care for HPV Vaccine|Study participants in control sites will receive standard care for HPV vaccine administration and follow-up per PPFA protocol
815142|NCT01343277|B3|Baseline|Total|Total of all reporting groups
815143|NCT01343277|B2|Baseline|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815144|NCT01343277|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815145|NCT01343277|P2|Participant Flow|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815146|NCT01343277|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815147|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815148|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815149|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815150|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815259|NCT01342965|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815151|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815152|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815153|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815154|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815155|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815156|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815157|NCT01343277|O2|Outcome|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815158|NCT01343277|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815159|NCT01343277|E2|Reported Event|Dacarbazine|Dacarbazine at a dose of 1 gram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 20-120 minutes every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each dacarbazine infusion.
815160|NCT01343277|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (IV) infusion over 24-hour every 3 weeks on Day 1 of every cycle (21 days) until disease progression. Dexamethasone 20 mg IV was also administered within 30 minutes before start of each trabectedin infusion.
815161|NCT01343251|B3|Baseline|Total|Total of all reporting groups
815162|NCT01343251|B2|Baseline|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
815163|NCT01343251|B1|Baseline|HeRO Graft|patients who are evaluated and receive a HeRO graft implant for hemodialysis
815164|NCT01343251|P2|Participant Flow|Control|control group of non-HeRO patients who are evaluated but do not receive a HeRO graft for any reason
815178|NCT01343082|B1|Baseline|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
815179|NCT01343082|P3|Participant Flow|Allocated to Tafluprost + Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5%.
815180|NCT01343082|P2|Participant Flow|Allocated to Timolol|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation).
815181|NCT01343082|P1|Participant Flow|Allocated to Tafluprost|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation) .
815182|NCT01343082|O1|Outcome|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
815183|NCT01343082|E1|Reported Event|DE-111|Switched to DE-111 ophthalmic solution (one drop at a time, once daily, bilateral topical instillation) from Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily, bilateral topical instillation), Timolol ophthalmic solution 0.5% (one drop at a time, BID, bilateral topical instillation), or concomitant Tafluprost ophthalmic solution 0.0015% plus Timolol ophthalmic solution 0.5% .
815184|NCT01343056|B5|Baseline|Total|Total of all reporting groups
815185|NCT01343056|B4|Baseline|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815186|NCT01343056|B3|Baseline|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815205|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815187|NCT01343056|B2|Baseline|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815188|NCT01343056|B1|Baseline|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815189|NCT01343056|P4|Participant Flow|Educator Support Follow up|A diabetes educator provided support to patients with periodic phone calls. Diabetes educators received training in ways to improve patient empowerment and best support their patients following diabetes education.
815190|NCT01343056|P3|Participant Flow|Usual Care|ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call was made by a diabetes educator.
815191|NCT01343056|P2|Participant Flow|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer met with the participant at their 6 week follow up visit and then called the participant monthly to monitor goal attainment."
815192|NCT01343056|P1|Participant Flow|Office Staff Follow up of Diabetes Education|A designee in the office shall be assigned to follow up with the patient for goal attainment. It was suggested that they phone the participant monthly. Staff also received training on how best to provide support to patients.
815193|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.~Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
815194|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
815195|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
815196|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
815197|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815233|NCT01343004|P3|Participant Flow|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815198|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815199|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815200|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815201|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.~Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
815202|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
815203|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
815204|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
815206|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815207|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815208|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815209|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815210|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815211|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815212|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815213|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815214|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815215|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815216|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815217|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support and make monthly call to the patient to ascertain goal attainment.~Educator Support: Diabetes educators provided patient follow up support that was problem-focused and patient centered."
815218|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Usual Care Support: Diabetes educators provided patient follow up support according to traditional clinical guidelines following completion of diabetes self-management."
815219|NCT01343056|O2|Outcome|Peer Follow up Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Peer Support: Community peers trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
815220|NCT01343056|O1|Outcome|Office Staff Follow up Education|"A designee in the office staff shall be assigned to follow up with the patient for goal attainment. The office staff will call patients monthly to monitor goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Office Staff Support: Office staff of primary care practices trained to provide diabetes support were tasked to follow up with patients via phone following completion of diabetes self-management education."
815221|NCT01343056|O4|Outcome|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815222|NCT01343056|O3|Outcome|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815223|NCT01343056|O2|Outcome|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815224|NCT01343056|O1|Outcome|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815225|NCT01343056|E4|Reported Event|Educator Support Follow up|"A diabetes educator will provide follow up support.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815226|NCT01343056|E3|Reported Event|Usual Care|"ADA Recognition maintains the standard that a follow up to diabetes education must occur from 3-6 month post education. This one phone call will be made by the diabetes educator.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815227|NCT01343056|E2|Reported Event|Peer Follow up of Diabetes Education|"A person with diabetes trained as a peer shall meet the participant at their 6 week follow up visit and then call the participant monthly to monitor goal attainment.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815228|NCT01343056|E1|Reported Event|Office Staff Follow up of Diabetes Education|"A designee in the office shall be assigned to follow up with the patient for goal attainment. It will be suggested that they phone the participant monthly but researchers will observe how and if they provide follow up.~Four different methods of follow up of goal attainment post diabetes education shall be evaluated.: The four arms are described. All participants will receive a 6 week, 3 month and 6 month office visit where they will complete surveys and have blood work for HbA1C and Lipids."
815229|NCT01343004|B4|Baseline|Total|Total of all reporting groups
815230|NCT01343004|B3|Baseline|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815231|NCT01343004|B2|Baseline|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815235|NCT01343004|P1|Participant Flow|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815236|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815237|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815238|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815239|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815240|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815241|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815242|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815243|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815244|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815245|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815246|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815247|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815248|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815249|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815250|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815251|NCT01343004|O3|Outcome|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815252|NCT01343004|O2|Outcome|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815253|NCT01343004|O1|Outcome|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815254|NCT01343004|E3|Reported Event|Teriparatide|"Blinded until after randomization, then open-label~teriparatide: teriparatide 20 mcg subcutaneous daily"
815255|NCT01343004|E2|Reported Event|BA058 80 mcg (Abaloparatide)|BA058 80 mcg: BA058 80 mcg subcutaneous daily
815256|NCT01343004|E1|Reported Event|Placebo|"Placebo identical in appearance to BA058 study drug~Placebo: Placebo 0 mcg subcutaneous daily"
815257|NCT01342965|B3|Baseline|Total|Total of all reporting groups
815258|NCT01342965|B2|Baseline|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815260|NCT01342965|P2|Participant Flow|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815261|NCT01342965|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815262|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815263|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815264|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815265|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815266|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815267|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815268|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815269|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815270|NCT01342965|O2|Outcome|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815271|NCT01342965|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815272|NCT01342965|E2|Reported Event|Chemotherapy|Participants received gemcitabine 1250 mg/m^2 intravenously (IV) on Days 1 and 8 and cisplatin 75 mg/m^2 IV on Day 1 of every 3 week cycle until disease progression, unacceptable toxicity, or a total of 4 cycles, whichever came first.
815273|NCT01342965|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once daily until progressive disease or unacceptable toxicity.
815274|NCT01342926|B5|Baseline|Total|Total of all reporting groups
815275|NCT01342926|B4|Baseline|GSK933776 15 mg/kg|15 mg/kg administration of GSK933776 via intravenous infusion
815276|NCT01342926|B3|Baseline|GSK933776 6 mg/kg|6 mg/kg administration of GSK933776 via intravenous infusion
815277|NCT01342926|B2|Baseline|GSK933776 3 mg/kg|3 mg/kg administration of GSK933776 via intravenous infusion
815278|NCT01342926|B1|Baseline|Placebo|Placebo via intravenous infusion
815279|NCT01342926|P4|Participant Flow|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815280|NCT01342926|P3|Participant Flow|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815281|NCT01342926|P2|Participant Flow|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815282|NCT01342926|P1|Participant Flow|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815283|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815284|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815285|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815286|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815287|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815288|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815289|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815290|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815291|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815292|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815293|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815294|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815295|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815296|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815297|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815298|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815299|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815300|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815301|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815302|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815303|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815304|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815305|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815306|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815307|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815308|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815309|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815310|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815311|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815312|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815313|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815314|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815315|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815316|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815317|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815318|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815319|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815320|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815321|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815322|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815323|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815324|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815325|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815326|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815327|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815328|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815329|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815330|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815331|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815332|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815333|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815334|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815335|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815336|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815337|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815338|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815339|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815340|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815341|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815342|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815343|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815344|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815345|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815346|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815347|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815349|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815350|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815351|NCT01342926|O4|Outcome|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815352|NCT01342926|O3|Outcome|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815353|NCT01342926|O2|Outcome|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815354|NCT01342926|O1|Outcome|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815355|NCT01342926|E4|Reported Event|GSK933776 (15 mg/kg)|Participants received 15 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815356|NCT01342926|E3|Reported Event|GSK933776 (6 mg/kg)|Participants received 6 mg/kg GSK933776 by IV infusion every 28 days for 18 months.
815357|NCT01342926|E2|Reported Event|GSK933776 (3 mg/kg)|Participants received 3 milligram (mg)/kilogram (kg) GSK933776 by IV infusion every 28 days for 18 months.
815358|NCT01342926|E1|Reported Event|Placebo|Participants received placebo (0.9 percent sodium chloride) by intravenous (IV) infusion every 28 days for 18 months.
815359|NCT01342913|B3|Baseline|Total|Total of all reporting groups
815360|NCT01342913|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
815361|NCT01342913|B1|Baseline|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
815362|NCT01342913|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
815363|NCT01342913|P2|Participant Flow|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
815392|NCT01342549|P1|Participant Flow|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
815364|NCT01342913|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
815365|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
815366|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
815367|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
815368|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
815369|NCT01342913|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
815370|NCT01342913|O1|Outcome|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
815371|NCT01342913|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
815372|NCT01342913|E1|Reported Event|Salmeterol/FP 50/500 µg BID|Participants received a Salmeterol and Fluticasone Propionate (FP) 50/500 microgram (µg) inhalation (available as a combination dry inhalation powder of Salmeterol 50 µg and FP 500 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
815373|NCT01342666|B3|Baseline|Total|Total of all reporting groups
815374|NCT01342666|B2|Baseline|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
815375|NCT01342666|B1|Baseline|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
815376|NCT01342666|P2|Participant Flow|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
815377|NCT01342666|P1|Participant Flow|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
815378|NCT01342666|O2|Outcome|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
815379|NCT01342666|O1|Outcome|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
815380|NCT01342666|E2|Reported Event|Cucumber Consumption|Participants were randomized to receive 300 g of cucumber (control group).
815381|NCT01342666|E1|Reported Event|Tomato Consumption|Participants were randomized to receive 300 g of uncooked tomato (2 daily roma tomatoes approximately).
815382|NCT01342640|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
815383|NCT01342640|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta (Mircera, Continuous Erythropoietin Receptor Activator [C.E.R.A]) at a starting dose of 1.2 micrograms per kilogram (mcg/kg) administered via subcutaneous (SC) injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s hemoglobin (Hb) level.
815384|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
815385|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
815386|NCT01342640|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
815387|NCT01342640|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta at a starting dose of 1.2 mcg/kg administered via SC injection every 4 weeks for 28 weeks. Doses were adjusted according to individual’s Hb level.
815388|NCT01342549|B3|Baseline|Total|Total of all reporting groups
815389|NCT01342549|B2|Baseline|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
815390|NCT01342549|B1|Baseline|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
815393|NCT01342549|O2|Outcome|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
815394|NCT01342549|O1|Outcome|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
815395|NCT01342549|E2|Reported Event|Arm 2|"naltrexone~Naltrexone: 25mg per day, taken by mouth for 7 days, then 50mg per day"
815396|NCT01342549|E1|Reported Event|Arm 1|"sodium valproate~Valproate: 250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60mg per day. Usual dosage is between 1250mg to 2000mg per day"
815397|NCT01342523|B33|Baseline|Total|Total of all reporting groups
815398|NCT01342523|B32|Baseline|CIS/Loz/Emails/Full Website/Full Booklet|
815399|NCT01342523|B31|Baseline|CIS/Loz/no Emails/Full Website/Full Booklet|
815400|NCT01342523|B30|Baseline|CIS/no Loz/Emails/Full Website/Full Booklet|
815401|NCT01342523|B29|Baseline|No CIS/Loz/Emails/Full Website/Full Booklet|
815402|NCT01342523|B28|Baseline|CIS/Loz/Emails/Lite Website/Full Booklet|
815403|NCT01342523|B27|Baseline|CIS/Loz/Emails/Full Website/Brief Booklet|
815404|NCT01342523|B26|Baseline|no CIS/no Loz/Emails/Full Website/Full Booklet|
815405|NCT01342523|B25|Baseline|No CIS/Loz/no Emails/Full Website/Full Booklet|
815406|NCT01342523|B24|Baseline|No CIS/Loz/Emails/Lite Website/Full Booklet|
815407|NCT01342523|B23|Baseline|No CIS/Loz/Emails/Full Website/Brief Booklet|
815408|NCT01342523|B22|Baseline|CIS/no Loz/no Email/Full Website/Full Booklet|
815409|NCT01342523|B21|Baseline|CIS/no Loz/Emails/Lite Website/Full Booklet|
815410|NCT01342523|B20|Baseline|CIS/no Loz/Emails/Full Website/Brief Booklet|
815411|NCT01342523|B19|Baseline|CIS/Loz/no Email/Lite Website/Full Booklet|
815412|NCT01342523|B18|Baseline|CIS/Loz/no Email/Full Website/Brief Booklet|
815413|NCT01342523|B17|Baseline|CIS/Loz/Emails/Lite Website/Brief Booklet|
815414|NCT01342523|B16|Baseline|no CIS/no Loz/no Email/Full Website/Full Booklet|
815415|NCT01342523|B15|Baseline|no CIS/no Loz/Emails/Lite Web/Full Booklet|
815416|NCT01342523|B14|Baseline|no CIS/no Loz/Emails/Full Website/Brief Booklet|
815417|NCT01342523|B13|Baseline|No CIS/Loz/No Emails/Full Website/Lite Booklet|
815418|NCT01342523|B12|Baseline|No CIS/Loz/No Emails/Lite Website/Full Booklet|
815419|NCT01342523|B11|Baseline|No CIS/Loz/Emails/Lite Website/Brief Booklet|
815420|NCT01342523|B10|Baseline|CIS/No Loz/no Email/Lite Website/Full Booklet|
815421|NCT01342523|B9|Baseline|CIS/No Loz/no Email/Full Website/Brief Booklet|
815422|NCT01342523|B8|Baseline|CIS/No Loz/Emails/Lite Website/Brief Booklet|
815423|NCT01342523|B7|Baseline|CIS/Loz/No Email/Lite Website/Brief Booklet|
815424|NCT01342523|B6|Baseline|No CIS/No Loz/No Email/Lite Website/Full Booklet|
815425|NCT01342523|B5|Baseline|No CIS/No Loz/No Email/Full Website/Brief Booklet|
815426|NCT01342523|B4|Baseline|No CIS/no Loz/Email/Lite Website/Brief Booklet|
815427|NCT01342523|B3|Baseline|no CIS/Loz/No Email/Lite Website/Brief Booklet|
815428|NCT01342523|B2|Baseline|CIS/No Loz/No Email/Lite Website/Brief Booklet|
815429|NCT01342523|B1|Baseline|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
815435|NCT01342523|P27|Participant Flow|CIS/Loz/Emails/Full Website/Brief Booklet|
815436|NCT01342523|P26|Participant Flow|no CIS/no Loz/Emails/Full Website/Full Booklet|
815437|NCT01342523|P25|Participant Flow|No CIS/Loz/no Emails/Full Website/Full Booklet|
815438|NCT01342523|P24|Participant Flow|No CIS/Loz/Emails/Lite Website/Full Booklet|
815439|NCT01342523|P23|Participant Flow|No CIS/Loz/Emails/Full Website/Brief Booklet|
815440|NCT01342523|P22|Participant Flow|CIS/no Loz/no Email/Full Website/Full Booklet|
815441|NCT01342523|P21|Participant Flow|CIS/no Loz/Emails/Lite Website/Full Booklet|
815442|NCT01342523|P20|Participant Flow|CIS/no Loz/Emails/Full Website/Brief Booklet|
815443|NCT01342523|P19|Participant Flow|CIS/Loz/no Email/Lite Website/Full Booklet|
815444|NCT01342523|P18|Participant Flow|CIS/Loz/no Email/Full Website/Brief Booklet|
815445|NCT01342523|P17|Participant Flow|CIS/Loz/Emails/Lite Website/Brief Booklet|
815446|NCT01342523|P16|Participant Flow|no CIS/no Loz/no Email/Full Website/Full Booklet|
815447|NCT01342523|P15|Participant Flow|no CIS/no Loz/Emails/Lite Web/Full Booklet|
815448|NCT01342523|P14|Participant Flow|no CIS/no Loz/Emails/Full Website/Brief Booklet|
815449|NCT01342523|P13|Participant Flow|No CIS/Loz/No Emails/Full Website/Lite Booklet|
815450|NCT01342523|P12|Participant Flow|No CIS/Loz/No Emails/Lite Website/Full Booklet|
815451|NCT01342523|P11|Participant Flow|No CIS/Loz/Emails/Lite Website/Brief Booklet|
815452|NCT01342523|P10|Participant Flow|CIS/No Loz/no Email/Lite Website/Full Booklet|
815453|NCT01342523|P9|Participant Flow|CIS/No Loz/no Email/Full Website/Brief Booklet|
815454|NCT01342523|P8|Participant Flow|CIS/No Loz/Emails/Lite Website/Brief Booklet|
815455|NCT01342523|P7|Participant Flow|CIS/Loz/No Email/Lite Website/Brief Booklet|
815456|NCT01342523|P6|Participant Flow|No CIS/No Loz/No Email/Lite Website/Full Booklet|
815457|NCT01342523|P5|Participant Flow|No CIS/No Loz/No Email/Full Website/Brief Booklet|
815458|NCT01342523|P4|Participant Flow|No CIS/no Loz/Email/Lite Website/Brief Booklet|
815459|NCT01342523|P3|Participant Flow|no CIS/Loz/No Email/Lite Website/Brief Booklet|
815460|NCT01342523|P2|Participant Flow|CIS/No Loz/No Email/Lite Website/Brief Booklet|
815461|NCT01342523|P1|Participant Flow|No CIS/No Loz/No Email/Lite Website/Brief Booklet|
815462|NCT01342523|O10|Outcome|Brief Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received a 12-page booklet developed by the investigators. The content of this booklet was the same as contained in the 36-page Clearing the Air booklet except that information directly relevant to coping skill training (identification of smoking triggers, making coping plans) was removed. Approximately half of the total sample of 1034 participants was randomized to receive the Brief Cessation Booklet; the other half received the Full Cessation Booklet."
815463|NCT01342523|O9|Outcome|Full Cessation Booklet|"Participants in the Full Cessation Booklet intervention group received the National Cancer Institute’s 36-page Clearing the Air brochure (www.smokefree.gov/pubs/clearing_the_air.pdf), containing a detailed guide for preparing to quit, quitting, and preventing relapse as well as suggested resources. Approximately half of the total sample of 1034 participants was randomized to receive the Full Cessation Booklet; the other half received a Brief Cessation Booklet."
815464|NCT01342523|O8|Outcome|Lite SmokeFree.Gov Website|Participants in the Lite SmokeFree.gov Website intervention group received received the “Lite” version of the website (developed by the investigators for this research) that included information about smoking and health such as benefits of quitting and information about withdrawal, medications and stress, but contained no interactive features or content that would support skill training. The look and graphics directly mirrored the full smokefree.gov website, but the number of web pages was reduced from over 50 to 16, and external links to resources were virtually eliminated. Approximately half of the total sample of 1034 participants was randomized to receive theLite SmokeFree.gov Website; the other half received the Full SmokeFree.gov Website.
815465|NCT01342523|O7|Outcome|Full SmokeFree.Gov Website|Participants in the Full SmokeFree.gov website intervention group received the standard smokefree.gov website content that included resources to motivate quitting and a step-by-step quitting guide that provided a skill-based intervention for preparing to quit, quitting, and maintaining abstinence. In addition, the active website offered encouragement and support, motivational information, and interactive features and referral links. The active website did not include direct interaction with users (e.g. live help) or interactive audio or video content. User-engagement features included task charts for behavior change, self-monitoring tools (e.g. for cravings and self-assessment), creation of a personal calendar, links to a quitline or to a counselor via text message for live help and social support through social media. No tailoring, feedback or outbound reminders were in use. Approximately half of the total sample of 1034 participants was randomized to receive the Full Smoke
815466|NCT01342523|O6|Outcome|No Email Messaging|Participants in this intervention group received no Email Messaging. Approximately half of the total sample of 1034 participants was randomized to receive no Email Messaging; the other half received 3 months of Email Messaging.
815467|NCT01342523|O5|Outcome|Email Messaging|Participants Email Messaging intervention group received brief email messages that could be accessed by any computer or mobile device that allowed email receipt. Messages were intended to provide: (1) Motivation/encouragement; (2) Quitting tips and information; (3) Adherence/education prompts (to use available resources as recommended), and (4) relapse prevention content. These emailed messages were sent twice/day for two weeks, once/day for an additional month, and then one every 3rd day for an additional 6 weeks (constituting a 3-month-long intervention). Approximately half of the total sample of 1034 participants was randomized to receive Email Messaging; the other half received no Email Messaging.
815468|NCT01342523|O4|Outcome|No Nicotine Replacement Therapy|Participants in this intervention group received no nicotine replacement therapy (NRT), i.e., no nicotine mini-lozenges. Approximately half of the total sample of 1034 participants was randomized to receive no NRT; the other half a 2-week supply of nicotine mini-lozenges.
815567|NCT01342341|B2|Baseline|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815469|NCT01342523|O3|Outcome|Nicotine Replacement Therapy (NRT; Mini-Lozenge for 2 Weeks)|Participants in this intervention group received a 2-week starter package of nicotine mini-lozenges, with dose based on time to since first cigarette of the day as per package instructions. Each package contained 2 mini-lozenge dispensers (162 lozenges total) and instructions on proper use. Approximately half of the total sample of 1034 participants was randomized to receive the 2-week supply of mini-lozenges; the other half received no mini-lozenges.
815470|NCT01342523|O2|Outcome|"No Cancer Information Service Counseling (No CIS)"|"Participants in this intervention group did not receive telephone quitline counseling from the Cancer Information Service (CIS). This intervention group will be compared to an intervention group that did receive telephone quitline counseling from the CIS. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (No CIS) and the other half to the CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 581 participants were randomized to No CIS group and 453 to the CIS group."
815471|NCT01342523|O1|Outcome|"Cancer Information Service Counseling (CIS)"|"Participants in this intervention group received telephone quitline counseling from the Cancer Information Service (CIS). These proactive calls initiated by CIS included an initial call (30 min), occurring within 3 days of enrollment, plus 4 additional counseling calls (up to 15 min each) scheduled to occur on the quit day or the day after, and then weekly for the next 3 weeks. The content of the counseling calls focused initially on motivating quitting and then setting a quit date, providing support, building self-efficacy, and skill training. The CIS intervention group will be compared to a No CIS group. The original randomization plan called for approximately half of the total sample of 1034 participants to be randomized to this intervention group (CIS) and the other half to the No CIS intervention group. However, due to a problem in the electronic transfer of data from the research coordinating site to CIS, 453 participants were randomized to CIS and 581 to the No CIS group."
815472|NCT01342523|E1|Reported Event|Lozenge|2 week supply of nicotine mini-lozenge. This is the only study arm for which adverse events were appropriate to be collected and analyzed, since all other arms did not involve interventions that could generate an adverse event report.
815473|NCT01342510|B5|Baseline|Total|Total of all reporting groups
815474|NCT01342510|B4|Baseline|Control|0.9% saline in a 10 cc syringe
815475|NCT01342510|B3|Baseline|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
815476|NCT01342510|B2|Baseline|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
815477|NCT01342510|B1|Baseline|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
815478|NCT01342510|P4|Participant Flow|Control|0.9% saline in a 10 cc syringe
817680|NCT01335230|E4|Reported Event|10 Control Subjects|10 subjects without HIV, HCV, or both
815479|NCT01342510|P3|Participant Flow|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
815480|NCT01342510|P2|Participant Flow|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
815481|NCT01342510|P1|Participant Flow|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
815482|NCT01342510|O4|Outcome|Control|0.9% saline in a 10 cc syringe
815483|NCT01342510|O3|Outcome|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
815484|NCT01342510|O2|Outcome|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
815485|NCT01342510|O1|Outcome|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
815486|NCT01342510|E4|Reported Event|Control|0.9% saline in a 10 cc syringe
815487|NCT01342510|E3|Reported Event|Lidocaine/Magnesium|Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe
815488|NCT01342510|E2|Reported Event|Magnesium|Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe
815489|NCT01342510|E1|Reported Event|Lidocaine|Lidocaine 50 mg in a 10 cc syringe
815490|NCT01342484|B4|Baseline|Total|Total of all reporting groups
815491|NCT01342484|B3|Baseline|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
815492|NCT01342484|B2|Baseline|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
815493|NCT01342484|B1|Baseline|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
815494|NCT01342484|P3|Participant Flow|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
815495|NCT01342484|P2|Participant Flow|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
815496|NCT01342484|P1|Participant Flow|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
815497|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
815498|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
815499|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
815500|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
815501|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
815502|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
815503|NCT01342484|O3|Outcome|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
815504|NCT01342484|O2|Outcome|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
815505|NCT01342484|O1|Outcome|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
815506|NCT01342484|E3|Reported Event|Linagliptin 5 mg|Linagliptin 5 mg dose was administered orally once daily for 12 weeks
815507|NCT01342484|E2|Reported Event|Linagliptin 1 mg|Linagliptin 1 mg dose was administered orally once daily for 12 weeks
815508|NCT01342484|E1|Reported Event|Placebo|Matching placebo dose was administered orally once daily for 12 weeks
815509|NCT01342471|B3|Baseline|Total|Total of all reporting groups
815597|NCT01342081|B4|Baseline|Total|Total of all reporting groups
815598|NCT01342081|B3|Baseline|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
815510|NCT01342471|B2|Baseline|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815511|NCT01342471|B1|Baseline|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815512|NCT01342471|P2|Participant Flow|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815513|NCT01342471|P1|Participant Flow|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815550|NCT01342445|B2|Baseline|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline only and received no drug.
815514|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815515|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815516|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815517|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815528|NCT01342458|B1|Baseline|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
815518|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815519|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815520|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815521|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815522|NCT01342471|O2|Outcome|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815523|NCT01342471|O1|Outcome|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815524|NCT01342471|E2|Reported Event|TV Commercial Stepping|"Instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Rather than exercising continuously for at least 10-minute bouts, participants performed multiple (~9 or 10), short (~3-5 min) bouts, conveniently incorporated into their daily TV viewing time.~TV commercial stepping : Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815525|NCT01342471|E1|Reported Event|30-min Walk|"Instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Participants were permitted to exercise in one long bout (30 min) or divide the exercise into multiple bouts as long as the bout length was 10 min or greater.~30-min walk : Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
815526|NCT01342458|B3|Baseline|Total|Total of all reporting groups
815527|NCT01342458|B2|Baseline|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
815529|NCT01342458|P2|Participant Flow|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
817968|NCT01333501|B2|Baseline|Interferon Beta 1b|250 μg injected s.c. every other day
815530|NCT01342458|P1|Participant Flow|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
815531|NCT01342458|O2|Outcome|Control Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
815532|NCT01342458|O1|Outcome|Intervention Group|A rescue analgesic medication (paracetamol) was allowed only if necessary (2g/day max.)
815533|NCT01342458|O2|Outcome|Control Group|Knee adduction moment (KAM) first peak
815534|NCT01342458|O1|Outcome|Intervention Group|Knee adduction moment (KAM) first peak
815535|NCT01342458|O2|Outcome|Control Group|Six-minute walk test
815536|NCT01342458|O1|Outcome|Intervention Group|Six-minute walk test
815537|NCT01342458|O2|Outcome|Control Group|Global score of the Lequesne´s questionaire algo-functional.
815538|NCT01342458|O1|Outcome|Intervention Group|Global score of the Lequesne´s questionaire algo-functional.
815539|NCT01342458|O2|Outcome|Control Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
815540|NCT01342458|O1|Outcome|Intervention Group|The WOMAC total score is the sum of all subscale (pain, function and stiffness).
815541|NCT01342458|O2|Outcome|Control Group|WOMAC Physical function subscale
815542|NCT01342458|O1|Outcome|Intervention Group|WOMAC Physical function subscale
815543|NCT01342458|O2|Outcome|Control Group|WOMAC stiffness subscale
815544|NCT01342458|O1|Outcome|Intervention Group|WOMAC stiffness subscale
815545|NCT01342458|O2|Outcome|Control Group|WOMAC pain subscale
815546|NCT01342458|O1|Outcome|Intervention Group|WOMAC pain subscale
815547|NCT01342458|E2|Reported Event|Control Group|During the intervention period, patients from the Control Group (CG) were instructed not to wear Moleca® or other similar minimalist footwear. During everyday activities, the CG group was only permitted to wear a standard, neutral tennis shoe. At the end of the intervention period, all CG participants also received one pair of Moleca® shoes at no cost.
815548|NCT01342458|E1|Reported Event|Intervention Group|Daily use of the intervention footwear (Moleca®) for 6 months, for at least 42 hours/week (approximately 6 hours/day, 7 days/week). The Moleca® shoe (Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a low-cost women’s double canvas, flexible, flat, walking shoe without heels, with a 5-mm anti-slip rubber sole and a 3-mm flat insole of ethylene vinyl acetate that provides only protection but no correction. The mean weight of the shoe is 0.172±0.019 kg (range 0.091 to 0.182 kg), depending on size. This minimalist footwear is commonly worn by the elderly of all social classes and its average cost is US$ 6.25.
815549|NCT01342445|B3|Baseline|Total|Total of all reporting groups
815551|NCT01342445|B1|Baseline|ADHD Participants|All participants completed the Conners' Adult ADHD Rating Scales–Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning–Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg LDX in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition.
815552|NCT01342445|P2|Participant Flow|Attention-deficit/Hyperactivity Disorder (ADHD) Participants|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline and were randomly assigned to one of six medication orders using placebo, 30-mg, 50 and 70 mg lisdexamfetamine dimesylate (LDX) in the context of a double-blind, crossover design, with repeated measures at the end of each drug phase. Phase orders (following baseline) were assigned in a counterbalanced fashion across participants. To avoid starting any participant with the highest dosage, the 50-mg condition always preceded the 70-mg condition. Each phase was conducted for 1 week, and therefore, the total trial took place over 5 weeks and was able to be completed during a single semester. Participants ingested one pill per day on awakening.
815553|NCT01342445|P1|Participant Flow|Healthy Controls|All participants completed the Conners' Adult ADHD Rating Scales-Short Form (CAARS) and Behavior Rating Inventory of Executive Functioning-Adult Version (BRIEF) at baseline only and received no drug.
815554|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
815555|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
815556|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
815557|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
815558|NCT01342445|O4|Outcome|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
815559|NCT01342445|O3|Outcome|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
815560|NCT01342445|O2|Outcome|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
815561|NCT01342445|O1|Outcome|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
815562|NCT01342445|E4|Reported Event|LDX 70-mg|All participants receiving 70-mg LDX for 1 week in a double-blind, crossover design
815563|NCT01342445|E3|Reported Event|LDX 50-mg|All participants receiving 50-mg LDX for 1 week in a double-blind, crossover design
815564|NCT01342445|E2|Reported Event|LDX 30-mg|All participants receiving 30-mg LDX for 1 week in a double-blind, crossover design
815565|NCT01342445|E1|Reported Event|Placebo|All participants receiving Placebo for 1 week in a double-blind, crossover design
815566|NCT01342341|B3|Baseline|Total|Total of all reporting groups
815599|NCT01342081|B2|Baseline|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
817969|NCT01333501|B1|Baseline|Fingolimod|0.5 mg in capsules for oral administration once daily
815568|NCT01342341|B1|Baseline|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815569|NCT01342341|P2|Participant Flow|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815570|NCT01342341|P1|Participant Flow|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815571|NCT01342341|O2|Outcome|Placebo|"Group B Experimental: Twenty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815572|NCT01342341|O1|Outcome|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815573|NCT01342341|E2|Reported Event|Placebo|"Group B Experimental: Forty moderate to heavy social alcohol users as described above will receive placebo x 14 days.~NOTE: This is a cross-over design and subjects will participate in both arms.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815574|NCT01342341|E1|Reported Event|Parafon Forte|"Experimental: Twenty moderate to heavy social alcohol users (women=10-25 drinks/week, men=14-30 drinks/week) will receive 250 mg of chlorzoxazone BID (500 mg/day) x 7 days followed by 500 mg of chlorzoxazone BID (1000 mg/day) x 7 days.~Twenty moderate to heavy social alcohol users as described above will receive 500 mg chlorzoxazone BID (1000 mg/day) x 7 days followed by 750 mg chlorzoxazone BID (1500 mg per day) x 7 days.~Parafon Forte: Drug: Parafon Forte administered at study visit~Other: Placebo administered at study visit"
815575|NCT01342172|B1|Baseline|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
815576|NCT01342172|P1|Participant Flow|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
815577|NCT01342172|O1|Outcome|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
815578|NCT01342172|E1|Reported Event|Lenalidomide|lenalidomide in combination with gemcitabine and cisplatin (GCL) in patients with MUC
815579|NCT01342107|B3|Baseline|Total|Total of all reporting groups
815580|NCT01342107|B2|Baseline|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
815581|NCT01342107|B1|Baseline|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
815582|NCT01342107|P2|Participant Flow|Blister Pack|Contact lens removed directly from the blister pack randomly assigned to right eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to left eye for contralateral wear.
815583|NCT01342107|P1|Participant Flow|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to right eye, with contact lens removed directly from the blister pack assigned to left eye for contralateral wear.
815584|NCT01342107|O2|Outcome|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
815585|NCT01342107|O1|Outcome|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
815586|NCT01342107|E2|Reported Event|Blister Pack|Contact lens removed directly from the blister pack and inserted on day of dispense for 16 hours of wear.
815587|NCT01342107|E1|Reported Event|FID 114675A|Contact lens soaked overnight in an investigational multi-purpose disinfecting solution and inserted on day of dispense for 16 hours of wear.
815588|NCT01342094|B3|Baseline|Total|Total of all reporting groups
815589|NCT01342094|B2|Baseline|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
815590|NCT01342094|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815591|NCT01342094|P2|Participant Flow|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
815592|NCT01342094|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815593|NCT01342094|O2|Outcome|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
815594|NCT01342094|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815595|NCT01342094|E2|Reported Event|Timolol|Timolol ophthalmic solution 0.5% (one drop at a time, BID) and Placebo ophthalmic solution (one drop at a time, once daily) in both eyes.
815596|NCT01342094|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815600|NCT01342081|B1|Baseline|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815601|NCT01342081|P3|Participant Flow|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
815602|NCT01342081|P2|Participant Flow|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815603|NCT01342081|P1|Participant Flow|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815604|NCT01342081|O3|Outcome|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
815605|NCT01342081|O2|Outcome|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815606|NCT01342081|O1|Outcome|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815607|NCT01342081|E3|Reported Event|Tafluprost Plus Timolol|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Timolol ophthalmic solution 0.5% (one drop at a time, BID) in both eyes.
815608|NCT01342081|E2|Reported Event|Tafluprost|Tafluprost ophthalmic solution 0.0015% (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815609|NCT01342081|E1|Reported Event|DE-111|DE-111 ophthalmic solution (one drop at a time, once daily) and Placebo ophthalmic solution (one drop at a time, BID) in both eyes.
815610|NCT01341990|B3|Baseline|Total|Total of all reporting groups
815611|NCT01341990|B2|Baseline|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815612|NCT01341990|B1|Baseline|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815613|NCT01341990|P2|Participant Flow|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815614|NCT01341990|P1|Participant Flow|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815615|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815616|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815617|NCT01341990|O2|Outcome|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815618|NCT01341990|O1|Outcome|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815619|NCT01341990|E2|Reported Event|ReNu MultiPlus|Multi-purpose solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815620|NCT01341990|E1|Reported Event|FID 114675A|Multi-purpose disinfecting solution used per protocol-specified instructions for cleaning, rinsing, disinfecting/storing, and reinserting study contact lenses
815621|NCT01341977|B3|Baseline|Total|Total of all reporting groups
815622|NCT01341977|B2|Baseline|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
815623|NCT01341977|B1|Baseline|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
815624|NCT01341977|P2|Participant Flow|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
815625|NCT01341977|P1|Participant Flow|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
815626|NCT01341977|O2|Outcome|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
815627|NCT01341977|O1|Outcome|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
815628|NCT01341977|E2|Reported Event|ReNu Fresh Multi-Purpose Solution|ReNu Fresh Multi-Purpose Solution (MPS)
815629|NCT01341977|E1|Reported Event|Alcon MPDS|Alcon Multi-Purpose Disinfecting Solution (MPDS)
815630|NCT01341912|B1|Baseline|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
815631|NCT01341912|P1|Participant Flow|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
815632|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
815633|NCT01341912|O1|Outcome|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
815634|NCT01341912|E1|Reported Event|Human-cl rhFVIII|"Recombinant FVIII derived from a human cell line.~Human-cl rhFVIII : Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery."
815635|NCT01341782|B3|Baseline|Total|Total of all reporting groups
815636|NCT01341782|B2|Baseline|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815637|NCT01341782|B1|Baseline|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815638|NCT01341782|P2|Participant Flow|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (intact parathyroid hormone [iPTH] < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815639|NCT01341782|P1|Participant Flow|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815640|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815641|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815642|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815643|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815644|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815645|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815646|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815647|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815648|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815649|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815650|NCT01341782|O2|Outcome|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815651|NCT01341782|O1|Outcome|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815652|NCT01341782|E2|Reported Event|Maxacalcitol|Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.
815653|NCT01341782|E1|Reported Event|Paricalcitol|Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.
815654|NCT01341067|B1|Baseline|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
815655|NCT01341067|P1|Participant Flow|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
815656|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
815657|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
815658|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
815659|NCT01341067|O1|Outcome|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
815660|NCT01341067|E1|Reported Event|Basal Insulin, Approved Oral Medications|Basal insulin, with or without approved oral agents
815661|NCT01340937|B5|Baseline|Total|Total of all reporting groups
815985|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815662|NCT01340937|B4|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815663|NCT01340937|B3|Baseline|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815664|NCT01340937|B2|Baseline|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815665|NCT01340937|B1|Baseline|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815666|NCT01340937|P4|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815667|NCT01340937|P3|Participant Flow|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815668|NCT01340937|P2|Participant Flow|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815669|NCT01340937|P1|Participant Flow|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815670|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815671|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815859|NCT01340664|P1|Participant Flow|Placebo|Each patient received matching placebo twice daily for 18 weeks.
815672|NCT01340937|O2|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815673|NCT01340937|O1|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815674|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815675|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815676|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815677|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815678|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815679|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815680|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815681|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815682|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815683|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815684|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815685|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815686|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815687|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815688|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815689|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815690|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815691|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815692|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815693|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815694|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815695|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815696|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815860|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
815697|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815698|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815699|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815700|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815701|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815702|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815703|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815704|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815705|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815706|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815707|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815708|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815709|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815710|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815711|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815712|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815713|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815714|NCT01340937|O5|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815715|NCT01340937|O4|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815716|NCT01340937|O3|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815717|NCT01340937|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815718|NCT01340937|O1|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815719|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815720|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815721|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815861|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
815722|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815723|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815724|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815725|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815726|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815727|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815728|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815729|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815730|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815731|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815732|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815733|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815734|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815735|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815736|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815737|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815738|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815739|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815740|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815741|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815742|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815743|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815744|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815745|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815746|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815862|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
815747|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815748|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815749|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815750|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815751|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815752|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815753|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815754|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815755|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815756|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815757|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815758|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815759|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815760|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815761|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815762|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815763|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815764|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815765|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815766|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815767|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815768|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815769|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815770|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815771|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815863|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
815772|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815773|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815774|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815775|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815776|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815777|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815778|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815779|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815780|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815781|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815782|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815783|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815784|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815785|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815786|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815986|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815787|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815788|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815789|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815790|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815791|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815792|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815793|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815794|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815795|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815796|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815864|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
815797|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815798|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815799|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815800|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815801|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815802|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815803|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815804|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815805|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815806|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815807|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815808|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815809|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815810|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815811|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815987|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815812|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815813|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815814|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815815|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815816|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815817|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815818|NCT01340937|O5|Outcome|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815819|NCT01340937|O4|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815820|NCT01340937|O3|Outcome|V419 Lot C|V419 (Lot C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815821|NCT01340937|O2|Outcome|V419 Lot B|V419 (Lot B) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815822|NCT01340937|O1|Outcome|V419 Lot A|V419 (Lot A) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815823|NCT01340937|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, 6, and 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age; and Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age.
815824|NCT01340937|E1|Reported Event|V419 Lots A, B, and C Combined|V419 (Lot A, B, or C) 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Pentacel™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
815825|NCT01340794|B3|Baseline|Total|Total of all reporting groups
815826|NCT01340794|B2|Baseline|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
815827|NCT01340794|B1|Baseline|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815828|NCT01340794|P2|Participant Flow|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
815829|NCT01340794|P1|Participant Flow|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815830|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
815831|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815832|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
815833|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815834|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
815835|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815836|NCT01340794|O2|Outcome|Treatment: Pazopanib With Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
815837|NCT01340794|O1|Outcome|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815838|NCT01340794|O2|Outcome|Treatment: Pazopanib Run-in|"Cycle 1:~Patients receive 400 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 2:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-7 of a 14 day cycle.~Cycle 3 and beyond:~Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle."
815988|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815839|NCT01340794|O1|Outcome|Treatment: Pazopanib With no Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815840|NCT01340794|E2|Reported Event|Treatment: Pazopanib With Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815841|NCT01340794|E1|Reported Event|Treatment: Pazopanib Without Run-in|Patients receive 800 mg pazopanib hydrochloride PO QD on days 1-28 of a 28 day cycle.
815842|NCT01340768|B3|Baseline|Total|Total of all reporting groups
815843|NCT01340768|B2|Baseline|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
815844|NCT01340768|B1|Baseline|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
815845|NCT01340768|P2|Participant Flow|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
815846|NCT01340768|P1|Participant Flow|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
815847|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
815848|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
815849|NCT01340768|O2|Outcome|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin
815850|NCT01340768|O1|Outcome|Sitagliptin|Sitagliptin 100mg taken orally once daily, with or without metformin
815851|NCT01340768|E2|Reported Event|Sulfonylurea Therapy|Usual sulfonylurea therapy and dose for each participant, with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
815852|NCT01340768|E1|Reported Event|Sitagliptin|Sitagliptin 100mg taken orally once daily with or without metformin. All participants as treated population defined as all randomized participants who received at least one dose of study drug.
815853|NCT01340664|B4|Baseline|Total|Total of all reporting groups
815854|NCT01340664|B3|Baseline|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
815855|NCT01340664|B2|Baseline|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
815856|NCT01340664|B1|Baseline|Placebo|Each patient received matching placebo twice daily for 18 weeks.
815857|NCT01340664|P3|Participant Flow|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks.
815858|NCT01340664|P2|Participant Flow|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
815866|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
815867|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
815868|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
815869|NCT01340664|O3|Outcome|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
815870|NCT01340664|O2|Outcome|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks
815871|NCT01340664|O1|Outcome|Placebo|Each patient received matching placebo twice daily for 18 weeks.
815872|NCT01340664|E3|Reported Event|Canagliflozin 150 mg Bid|Each patient received 150 mg canagliflozin twice daily for 18 weeks
815873|NCT01340664|E2|Reported Event|Canagliflozin 50 mg Bid|Each patient received 50 mg canagliflozin twice daily for 18 weeks.
815874|NCT01340664|E1|Reported Event|Placebo|Each patient received matching placebo twice daily for 18 weeks
815875|NCT01340651|B1|Baseline|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815876|NCT01340651|P1|Participant Flow|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD. At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
815877|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
815878|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
815879|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD).
815880|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815881|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815882|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815883|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815884|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815989|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815885|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815886|NCT01340651|O1|Outcome|Ruxolitinib|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815887|NCT01340651|E2|Reported Event|Ruxolitinib - After Week 16|At Week 16, participants transitioned to ruxolitinib 10, 15, or 20 mg immediate release (IR) orally twice daily up to when the last participant completed Week 36 or the commercial availability of ruxolitinib IR, whichever was earlier; the dose received was based on platelet counts at the time of transition.
815888|NCT01340651|E1|Reported Event|Ruxolitinib - Weeks 1-16|Participants began administration with 25 mg ruxolitinib sustained release (SR) once daily (QD). After 8 weeks, if there was inadequate efficacy, the dose level could be titrated to 50 mg SR QD or 25 mg SR every other day (QOD) alternating with 50 mg SR QOD.
815889|NCT01340625|B3|Baseline|Total|Total of all reporting groups
815890|NCT01340625|B2|Baseline|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
815891|NCT01340625|B1|Baseline|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
815892|NCT01340625|P2|Participant Flow|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
815893|NCT01340625|P1|Participant Flow|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
815894|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
815895|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
815896|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
815897|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
815898|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
815899|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
815900|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
815901|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
815902|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
815903|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
815904|NCT01340625|O2|Outcome|Ovcon® 35 Fe (Reference)|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in either period.
815905|NCT01340625|O1|Outcome|Norethindrone/Ethinyl Estradiol (Test)|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in either period.
815906|NCT01340625|E2|Reported Event|Ovcon® 35 Fe (Reference) First|0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in first period followed by 0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in the second period.
815907|NCT01340625|E1|Reported Event|Norethindrone/Ethinyl Estradiol (Test) First|0.4 mg/35 mcg Norethindrone/Ethinyl Estradiol Chewable Tablets test product dosed in first period followed by 0.4 mg/35 mcg Ovcon® 35 Fe Chewable Tablets reference product dosed in the second period.
815908|NCT01340586|B3|Baseline|Total|Total of all reporting groups
815909|NCT01340586|B2|Baseline|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815910|NCT01340586|B1|Baseline|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815911|NCT01340586|P2|Participant Flow|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815912|NCT01340586|P1|Participant Flow|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815913|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815914|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815990|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815991|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815992|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815993|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815915|NCT01340586|O2|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815916|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815917|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815918|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815919|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815920|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815921|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815922|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815923|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815924|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815925|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815926|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815927|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815928|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815929|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815960|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815930|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815931|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815932|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815933|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815934|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
815935|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815936|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815937|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
815938|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815939|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815940|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815941|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
815942|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815943|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815944|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815945|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815946|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815947|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815948|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815949|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815950|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815951|NCT01340586|O1|Outcome|ESRD Maintained With Hemodialysis|Participants with End Stage Renal Disease (ESRD) maintained with hemodialysis received two doses of apixaban separated by a washout period of at least 7 days; one oral dose of 5mg apixaban 2 hours prior to hemodialysis on Day 1 of Period 1, and a second oral dose of 5mg apixaban immediately following the hemodialysis session on Day 1, Period 2.
815952|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815953|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815954|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815955|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815956|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
815957|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815958|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815959|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
816682|NCT01339260|B3|Baseline|Total|Total of all reporting groups
815961|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815962|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815963|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815964|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815965|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
815966|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815967|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815968|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815969|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815970|NCT01340586|O3|Outcome|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815971|NCT01340586|O2|Outcome|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis.
815972|NCT01340586|O1|Outcome|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815973|NCT01340586|E3|Reported Event|ESRD Dose After Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban immediately following the completion of hemodialysis.
815974|NCT01340586|E2|Reported Event|ESRD Dose Before Hemodialysis|Participants with ESRD received one oral dose of 5 mg apixaban 2 hours prior to hemodialysis on Day 1.
815975|NCT01340586|E1|Reported Event|Normal Renal Function|Healthy participants with normal renal function (calculated creatinine clearance (ClCr) > 80 mL/min) received a single oral dose of 5 mg apixaban on the morning of Day 1.
815976|NCT01340573|B1|Baseline|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
815977|NCT01340573|P1|Participant Flow|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
815978|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815979|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815980|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815981|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815982|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815983|NCT01340573|O1|Outcome|Genotype 1 CHC Participants|
815984|NCT01340573|O2|Outcome|Non-genotype 1 CHC Partipants|
815996|NCT01340573|E1|Reported Event|All Participants|Genotype 1 CHC Participants and Non-genotype 1 CHC partipants
815997|NCT01340209|B4|Baseline|Total|Total of all reporting groups
815998|NCT01340209|B3|Baseline|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
815999|NCT01340209|B2|Baseline|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816000|NCT01340209|B1|Baseline|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816001|NCT01340209|P3|Participant Flow|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816002|NCT01340209|P2|Participant Flow|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816003|NCT01340209|P1|Participant Flow|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816004|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816005|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816006|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816007|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816008|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816009|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816010|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816011|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816012|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816013|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
817686|NCT01335191|B1|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
816014|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816015|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816016|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816017|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816018|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816019|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816020|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816021|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816022|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816023|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816024|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816025|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816026|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816027|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816028|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816029|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816030|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816031|NCT01340209|O3|Outcome|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816032|NCT01340209|O2|Outcome|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816033|NCT01340209|O1|Outcome|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816034|NCT01340209|E3|Reported Event|Tiotropium Respimat (5 μg)|Tiotropium Respimat: Tiotropium 5 μg once daily delivered with Respimat inhaler
816035|NCT01340209|E2|Reported Event|Tiotropium Respimat (2.5 µg)|Tiotropium Respimat: Tiotropium 2.5 µg once daily delivered with Respimat inhaler
816036|NCT01340209|E1|Reported Event|Placebo Respimat|Placebo Respimat: Tiotropium placebo once daily delivered with Respimat inhaler
816037|NCT01340196|B1|Baseline|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
816038|NCT01340196|P1|Participant Flow|All Participants|tenofovir medium dose (300mg) once daily (qd, oral) for first 15 days; Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (300mg) twice daily (bid) on days 9 through day 22 (morning dose on day 22 only)
816039|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816040|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816041|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
816042|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816043|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816044|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
816045|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816046|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816047|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
816048|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816049|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816050|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
816051|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816052|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816053|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
816054|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816055|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816056|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
816057|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
817687|NCT01335191|P2|Participant Flow|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
816058|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816059|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7
816060|NCT01340196|O3|Outcome|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816061|NCT01340196|O2|Outcome|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816062|NCT01340196|O1|Outcome|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
816063|NCT01340196|E3|Reported Event|Faldaprevir|Faldaprevir medium dose (240mg) twice daily (bid) (day 16 to 22, last dose on morning of day 22)
816064|NCT01340196|E2|Reported Event|Tenofovir/Faldaprevir|tenofovir medium dose (300mg) once daily (qd) (day 8 to 15); Faldaprevir starting dose of 480mg and evening dose of 240mg on day 8; medium dose (240mg) twice daily (bid) on days 9 through day 15
816065|NCT01340196|E1|Reported Event|Tenofovir|tenofovir medium dose (300mg) once daily (qd) (day 1 to 7)
816066|NCT01340144|B3|Baseline|Total|Total of all reporting groups
816067|NCT01340144|B2|Baseline|PFC Sigma HP PS TKA (Total Knee Arthoplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
816068|NCT01340144|B1|Baseline|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
816069|NCT01340144|P2|Participant Flow|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
816070|NCT01340144|P1|Participant Flow|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
816071|NCT01340144|O2|Outcome|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
816072|NCT01340144|O1|Outcome|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
816073|NCT01340144|E2|Reported Event|PFC Sigma HP PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma HP PS TKA.
816074|NCT01340144|E1|Reported Event|PFC Sigma PS TKA (Total Knee Arthroplasty)|One group received primary TKA using the PFC Sigma PS TKA
816075|NCT01340066|B3|Baseline|Total|Total of all reporting groups
816076|NCT01340066|B2|Baseline|UISH001|At randomization at visit 2, subjects were treated with UISH001.
816077|NCT01340066|B1|Baseline|Matching Placebo|At randomization at visit 2, subjects were treated with matching placebo.
816078|NCT01340066|P3|Participant Flow|UISH001|Subjects were randomized at Visit 2
816079|NCT01340066|P2|Participant Flow|Placebo|Subjects were randomized at Visit 2
816080|NCT01340066|P1|Participant Flow|Placebo Run-In|All subjects entered a one week placebo run in period to qualify for the study.
816081|NCT01340066|O2|Outcome|UISH001|1 drop UISH001 sublingual 3 times/day
816082|NCT01340066|O1|Outcome|Placebo|1 drop Placebo sublingual 3 times/day
816083|NCT01340066|E3|Reported Event|Matching Placebo|Subjects were treated with matching placebo during double blind treatment period.
816084|NCT01340066|E2|Reported Event|UISH001|Subjects were treated with UISH001 during double blind treatment period.
816085|NCT01340066|E1|Reported Event|Non-Randomized Subjects|Adverse Events (AEs) captured for subjects that were not randomized
816086|NCT01340027|B13|Baseline|Total|Total of all reporting groups
816087|NCT01340027|B12|Baseline|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816088|NCT01340027|B11|Baseline|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816089|NCT01340027|B10|Baseline|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816090|NCT01340027|B9|Baseline|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816091|NCT01340027|B8|Baseline|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816092|NCT01340027|B7|Baseline|Solifenacin 2.5 mg +Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816093|NCT01340027|B6|Baseline|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816094|NCT01340027|B5|Baseline|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816095|NCT01340027|B4|Baseline|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816096|NCT01340027|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816097|NCT01340027|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816098|NCT01340027|B1|Baseline|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816099|NCT01340027|P12|Participant Flow|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816100|NCT01340027|P11|Participant Flow|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816101|NCT01340027|P10|Participant Flow|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816102|NCT01340027|P9|Participant Flow|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816103|NCT01340027|P8|Participant Flow|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816104|NCT01340027|P7|Participant Flow|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816105|NCT01340027|P6|Participant Flow|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
817826|NCT01334554|E2|Reported Event|Placebo|Participants received placebo three times a day for 4 weeks
816106|NCT01340027|P5|Participant Flow|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816107|NCT01340027|P4|Participant Flow|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816108|NCT01340027|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816109|NCT01340027|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816110|NCT01340027|P1|Participant Flow|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816111|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816112|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816113|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816114|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816115|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816116|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816117|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816118|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816119|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816120|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816121|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816122|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816123|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816124|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816125|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816126|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816127|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816128|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816129|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816130|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816131|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816132|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816133|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816134|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816135|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816136|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816137|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816138|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816139|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816140|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816141|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816142|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816143|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816144|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816145|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816146|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816147|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816148|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816149|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816150|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816151|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816152|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816153|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816154|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816155|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816156|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816157|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816158|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816159|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816160|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816161|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816162|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816163|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816164|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816165|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816166|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816167|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816168|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816169|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816170|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816171|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816172|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816173|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816174|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816175|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816176|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816177|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816178|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816179|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816180|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816181|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816182|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816183|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816184|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816185|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816186|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816187|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816188|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816189|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816190|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816191|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816192|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816193|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816194|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816195|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816196|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816197|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
817997|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
816198|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816199|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816200|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816201|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816202|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816203|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816204|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816205|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816206|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816207|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816208|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816209|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816210|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816211|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816212|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816213|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816214|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816215|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816216|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816217|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816218|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816219|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816220|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816221|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816222|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816223|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816224|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816225|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816226|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816227|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816228|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816229|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816230|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816231|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816232|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816233|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816234|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816235|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816236|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816237|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816238|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816239|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816240|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816241|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816242|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816243|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
817998|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
816244|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816245|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816246|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816247|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816248|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816249|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816250|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816251|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816252|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816253|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816254|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816255|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816256|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816257|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816258|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816259|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816260|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816261|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816262|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816263|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816264|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816265|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816266|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816267|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816268|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816269|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816270|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816271|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816272|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816273|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816274|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816275|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816276|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816277|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816278|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816279|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816280|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816281|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816282|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816283|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816284|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816285|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816286|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816287|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816288|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816289|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816290|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816291|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816292|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816293|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816294|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816295|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816296|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816297|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816298|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816299|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816300|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816301|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816302|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816303|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816304|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816305|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816306|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816307|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816308|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816309|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816310|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816311|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816312|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816313|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816314|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816315|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816316|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
817970|NCT01333501|P2|Participant Flow|Interferon Beta 1b|250 μg injected s.c. every other day
816317|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816318|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816319|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816320|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816321|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816322|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816323|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816324|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816325|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816326|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816327|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816328|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816329|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816330|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816331|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816332|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816333|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816334|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816335|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816336|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816337|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816338|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816339|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816340|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816341|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816342|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816343|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816344|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816345|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816346|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816347|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816348|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816349|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816350|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816351|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816352|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816353|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816354|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816355|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816356|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816357|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816358|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816359|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816360|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816361|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816362|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
817971|NCT01333501|P1|Participant Flow|Fingolimod|0.5 mg in capsules for oral administration once daily
816363|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816364|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816365|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816366|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816367|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816368|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816369|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816370|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816371|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816372|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816373|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816374|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816375|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816376|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816377|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816378|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816379|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816380|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816381|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816382|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816383|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816384|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816385|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816386|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816387|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816388|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816389|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816390|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816391|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816392|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816393|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816394|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816395|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816396|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816397|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816398|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816399|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816400|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816401|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816402|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816403|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816404|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816405|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816406|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816407|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816408|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816409|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816410|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816411|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816412|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816413|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816414|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816415|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816416|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816417|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816418|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816419|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816420|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816421|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816422|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816423|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816424|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816425|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816426|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816427|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
818113|NCT01333397|O5|Outcome|Dysport 50 U|
816428|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816429|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816430|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816431|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816432|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816433|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816434|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816435|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816436|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816437|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816438|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816439|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816440|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816441|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816442|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816443|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816444|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816445|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816446|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816447|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816448|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816449|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816450|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816451|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816452|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816453|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
817972|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
816454|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816455|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816456|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816457|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816458|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816459|NCT01340027|O12|Outcome|Solifenacin 10 mg + Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816460|NCT01340027|O11|Outcome|Solifenacin 10 mg + Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816461|NCT01340027|O10|Outcome|Solifenacin 5 mg + Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816462|NCT01340027|O9|Outcome|Solifenacin 5 mg + Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816463|NCT01340027|O8|Outcome|Solifenacin 2.5 mg + Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816464|NCT01340027|O7|Outcome|Solifenacin 2.5 mg + Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816465|NCT01340027|O6|Outcome|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816466|NCT01340027|O5|Outcome|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816467|NCT01340027|O4|Outcome|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816468|NCT01340027|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816469|NCT01340027|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816470|NCT01340027|O1|Outcome|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816471|NCT01340027|E12|Reported Event|Solifenacin 10 mg and Mirabegron 50 mg|Participants received solifenacin 10 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816472|NCT01340027|E11|Reported Event|Solifenacin 10 mg and Mirabegron 25 mg|Participants received solifenacin 10 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816473|NCT01340027|E10|Reported Event|Solifenacin 5 mg and Mirabegron 50 mg|Participants received solifenacin 5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
818114|NCT01333397|O4|Outcome|Dysport NG 75 U|
816474|NCT01340027|E9|Reported Event|Solifenacin 5 mg and Mirabegron 25 mg|Participants received solifenacin 5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816475|NCT01340027|E8|Reported Event|Solifenacin 2.5 mg and Mirabegron 50 mg|Participants received solifenacin 2.5 mg and mirabegron 50 mg tablets orally once a day for 12 weeks.
816476|NCT01340027|E7|Reported Event|Solifenacin 2.5 mg and Mirabegron 25 mg|Participants received solifenacin 2.5 mg and mirabegron 25 mg tablets orally once a day for 12 weeks.
816477|NCT01340027|E6|Reported Event|Solifenacin 10 mg|Participants received solifenacin 10 mg tablets orally once a day for 12 weeks.
816478|NCT01340027|E5|Reported Event|Solifenacin 5 mg|Participants received solifenacin 5 mg tablets orally once a day for 12 weeks.
816479|NCT01340027|E4|Reported Event|Solifenacin 2.5 mg|Participants received solifenacin 2.5 mg tablets orally once a day for 12 weeks.
816480|NCT01340027|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
816481|NCT01340027|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
816482|NCT01340027|E1|Reported Event|Placebo|Participants received matching placebo tablets orally once a day for 12 weeks.
816483|NCT01340014|B3|Baseline|Total|Total of all reporting groups
816484|NCT01340014|B2|Baseline|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
816485|NCT01340014|B1|Baseline|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
816486|NCT01340014|P2|Participant Flow|COSOPT/AZARGA|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop AZARGA instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
816487|NCT01340014|P1|Participant Flow|AZARGA/COSOPT|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1, followed by 1 drop COSOPT instilled in each eye twice a day for 7 days during Period 2. A 48-hour washout period separated the two treatment periods.
816488|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
816489|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
816490|NCT01340014|O2|Outcome|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
816491|NCT01340014|O1|Outcome|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
816492|NCT01340014|E2|Reported Event|COSOPT|1 drop COSOPT instilled in each eye twice a day for 7 days during Period 1 or Period 2
816493|NCT01340014|E1|Reported Event|AZARGA|1 drop AZARGA instilled in each eye twice a day for 7 days during Period 1 or Period 2
816494|NCT01339936|B1|Baseline|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
816495|NCT01339936|P1|Participant Flow|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
816703|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
816496|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
816497|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
816498|NCT01339936|O1|Outcome|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
816499|NCT01339936|E1|Reported Event|Investigational Eye Drop|Formulation 1: Carboxymethylcellulose sodium, glycerin and polysorbate 80 based eye drops formulated for the relief of ocular surface irritation and symptoms of dryness
816500|NCT01339923|B8|Baseline|TOTAL|Total of all reporting groups
816501|NCT01339923|B7|Baseline|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
816502|NCT01339923|B6|Baseline|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
816503|NCT01339923|B5|Baseline|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
816504|NCT01339923|B4|Baseline|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
816505|NCT01339923|B3|Baseline|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
816506|NCT01339923|B2|Baseline|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
816507|NCT01339923|B1|Baseline|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
816508|NCT01339923|P7|Participant Flow|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
816509|NCT01339923|P6|Participant Flow|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
816510|NCT01339923|P5|Participant Flow|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
817681|NCT01335230|E3|Reported Event|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
816511|NCT01339923|P4|Participant Flow|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
816512|NCT01339923|P3|Participant Flow|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
816513|NCT01339923|P2|Participant Flow|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
816514|NCT01339923|P1|Participant Flow|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
816515|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
816516|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816517|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816518|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816519|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816520|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
816521|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816559|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816704|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
816522|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
816523|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816524|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
816525|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816526|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816527|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816528|NCT01339923|O2|Outcome|B_02_6_10|"Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816529|NCT01339923|O1|Outcome|B_02_2_5|"Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816530|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816531|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
817682|NCT01335230|E2|Reported Event|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
816532|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816533|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816534|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
816535|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816536|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816537|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816538|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816539|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816540|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 ad 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
816541|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5 12 rMenB + OMV vaccine"
816542|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
816543|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816544|NCT01339923|O2|Outcome|C_35_12|"Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 13,15 rMenB + OMV vaccine"
816545|NCT01339923|O1|Outcome|BC_35_12|"Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.~Meningococcal C oligosaccharide conjugated vaccine: Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine~Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.: Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.~rMenB + OMV NZ vaccine: Schedule 3, 5, 12 rMenB + OMV vaccine"
816546|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816547|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816548|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
816549|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816550|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816551|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
816552|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816553|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816554|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
816555|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816556|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816557|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
816558|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816600|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
816601|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
816602|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
816560|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3-1/2, 5 months of age) plus booster (11 months of age)"
816561|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816562|NCT01339923|O3|Outcome|B_68_11b|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age. Blood draw at 8, 9, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816563|NCT01339923|O2|Outcome|B_3h5_11b|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 5, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
816564|NCT01339923|O1|Outcome|B_2h3h5_11b|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age. Blood draw at 3.5, 6, 11 and 12 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816565|NCT01339923|O4|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816566|NCT01339923|O3|Outcome|B_68_11|"Subjects, approximately 6 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (6, 8 months of age) plus booster (11 months of age)"
816567|NCT01339923|O2|Outcome|B_3h5_11|"Subjects, approximately 3.5 months of age, received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 2 doses (3.5, 5 months of age) plus booster (11 months of age)"
816568|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)"
816569|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816570|NCT01339923|O1|Outcome|B_02|"Subjects, 2-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.~rMenB + OMV NZ vaccine: 2 doses 2 months apart"
816571|NCT01339923|O1|Outcome|B_2h3h5_11|"Subjects, approximately 2.5 months of age, received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.~rMenB + OMV NZ vaccine: 3 doses (2.5, 3.5, 5 months of age) plus booster (11 months of age)"
817683|NCT01335230|E1|Reported Event|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
816572|NCT01339923|O2|Outcome|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
816573|NCT01339923|O1|Outcome|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
816574|NCT01339923|E8|Reported Event|TOTAL|All subjects in the safety population.
816575|NCT01339923|E7|Reported Event|C_35_12|Subjects, 3 months of age received MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone at 7 months of age and rMenB+OMV NZ alone at 13 and 15 months of age.
816576|NCT01339923|E6|Reported Event|BC_35_12|Subjects, 3 months of age received rMenB+OMV NZ + MenC-CRM and Synflorix concomitantly at 3, 5 and 12 months of age and an additional dose of Synflorix alone dose at 7 months of age.
816577|NCT01339923|E5|Reported Event|B_02_6_10|Subjects, 6-10 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
816578|NCT01339923|E4|Reported Event|B_02_2_5|Subjects, 2-5 years of age received 2 catch-up doses of rMenB+OMV NZ, each at 0 and 2 months. Blood draw at 0 and 3 months since study start.
816579|NCT01339923|E3|Reported Event|B_68_11|Subjects, approximately 6 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 6 and 8 months of age, followed by a booster dose at 11 months of age.
816580|NCT01339923|E2|Reported Event|B_3h5_11|Subjects, approximately 3.5 months of age received 2 dose primary vaccination of rMenB+OMV NZ at 3.5 and 5 months of age, followed by a booster dose at 11 months of age.
816581|NCT01339923|E1|Reported Event|B_2h3h5_11|Subjects, approximately 2.5 months of age received 3 dose primary vaccination of rMenB+OMV NZ at 2.5, 3.5, 5 months of age, followed by a booster dose at 11 months of age.
816582|NCT01339897|B5|Baseline|Total|Total of all reporting groups
816583|NCT01339897|B4|Baseline|Placebo|Non-Active
816584|NCT01339897|B3|Baseline|Cohort 3|N6022 - Active 20 mg
816585|NCT01339897|B2|Baseline|Cohort 2|N6022 - Active 10 mg
816586|NCT01339897|B1|Baseline|Cohort 1|N6022 - Active 5 mg
816587|NCT01339897|P4|Participant Flow|20 mg/N6022|Active Group- 20 mg by IV administration (5 mg/minute)
816588|NCT01339897|P3|Participant Flow|10 mg/N6022|Active Group- 10 mg by IV administration (5 mg/minute)
816589|NCT01339897|P2|Participant Flow|Placebo|Non-Active
816590|NCT01339897|P1|Participant Flow|5 mg/N6022|Active Group- 5 mg by IV administration (5 mg/minute)
816591|NCT01339897|O4|Outcome|Placebo|Non-Active
816592|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
816593|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
816594|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
816595|NCT01339897|O4|Outcome|Placebo|Non-Active
816596|NCT01339897|O3|Outcome|Cohort 3|N6022 Active - 20 mg
816597|NCT01339897|O2|Outcome|Cohort 2|N6022 Active - 10 mg
816598|NCT01339897|O1|Outcome|Cohort 1|N6022 Active - 5 mg
816599|NCT01339897|O4|Outcome|Placebo|Non-Active
816615|NCT01339832|B1|Baseline|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816616|NCT01339832|P1|Participant Flow|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816617|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816618|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816619|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816620|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816621|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816622|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816623|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816683|NCT01339260|B2|Baseline|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
816624|NCT01339832|O1|Outcome|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816625|NCT01339832|E1|Reported Event|Overall|Participants with histologically proven local advanced T3/T4 rectal carcinoma with or without nodal involvement who had participated in study ML18280 were enrolled and no active treatment was given during this study
816626|NCT01339429|B1|Baseline|Simplified Negative Pressure Wound Therapy|"The simplified Negative Pressure device will be placed on subjects selected from the hospital wards and meeting the eligibility criteria.~simplified Negative Pressure device: A non-powered negative pressure device utilizing a bellows which is compressed every eight hours."
816627|NCT01339429|P1|Participant Flow|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from hospital wards and meeting the eligibility criteria regarding wound size and condition. Inclusion criteria included age 14 years or older, adequate adjacent intact skin and wound location for application of the sNPWT dressing, adequate pain control, and anticipated clinically stability and hospitalization for the duration of the study. Exclusion criteria were exposed blood vessels, evidence of ischemia, necrotic tissue requiring further debridement, infection, osteomyelitis, and malignancy in the wound.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing via a drainage tube."
816628|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
816629|NCT01339429|O1|Outcome|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device will be placed on subjects selected from the surgical ward and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
816630|NCT01339429|E1|Reported Event|Simplified Negative Pressure Wound Therapy|"The simplified negative pressure wound therapy device was placed on subjects selected from the hospital wards and meeting the eligibility criteria regarding wound size and condition.~Simplified negative pressure wound therapy device: A non-powered negative pressure wound therapy device utilizing a bellows connected to a specialized dressing."
816631|NCT01339416|B1|Baseline|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816632|NCT01339416|P1|Participant Flow|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816633|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816634|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816635|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816636|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816705|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
816637|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816638|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816639|NCT01339416|O1|Outcome|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816640|NCT01339416|E1|Reported Event|All Participants|Participants who were diagnosed with Human immunodeficiency virus (HIV) infection and received HIV care during January 1, 2000 through December 31, 2010 (574 weeks) with follow-up extended up to 31st December 2011 (up to 626 weeks).
816641|NCT01339403|B3|Baseline|Total|Total of all reporting groups
816642|NCT01339403|B2|Baseline|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816643|NCT01339403|B1|Baseline|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816644|NCT01339403|P2|Participant Flow|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816645|NCT01339403|P1|Participant Flow|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816646|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816647|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816648|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816649|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816650|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816651|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816652|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816653|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816654|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816655|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816656|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816657|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816658|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816659|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816660|NCT01339403|O2|Outcome|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816661|NCT01339403|O1|Outcome|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816662|NCT01339403|E2|Reported Event|Cohort 2: HIV Uninfected|Participants who were not diagnosed with HIV infection during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816663|NCT01339403|E1|Reported Event|Cohort 1: HIV Infected|Participants who were diagnosed with HIV infection and received HIV care during January 1, 1996 through December 31, 2006 (574 weeks) with follow-up extended up to 31st December 2011 (up to 835 weeks).
816664|NCT01339390|B3|Baseline|Total|Total of all reporting groups
816699|NCT01339247|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
816665|NCT01339390|B2|Baseline|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
816666|NCT01339390|B1|Baseline|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
816667|NCT01339390|P2|Participant Flow|Arm 2: MOVE!|"As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This prompts the primary care provider (PCP) to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE! if they and the patient agree that it would be beneficial. The MOVE! program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
816684|NCT01339260|B1|Baseline|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
816685|NCT01339260|P2|Participant Flow|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
816668|NCT01339390|P1|Participant Flow|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE! program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
816669|NCT01339390|O2|Outcome|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
816670|NCT01339390|O1|Outcome|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
816671|NCT01339390|E2|Reported Event|Arm 2: MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs.~MOVE!: As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
816700|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
816701|NCT01339247|O1|Outcome|Test Product|Test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
816702|NCT01339247|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
817973|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
816672|NCT01339390|E1|Reported Event|Arm 1: MOVE OUT|"The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.~MOVE OUT: The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support."
816673|NCT01339299|B3|Baseline|Total|Total of all reporting groups
816674|NCT01339299|B2|Baseline|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816675|NCT01339299|B1|Baseline|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816676|NCT01339299|P2|Participant Flow|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816677|NCT01339299|P1|Participant Flow|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816678|NCT01339299|O2|Outcome|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816679|NCT01339299|O1|Outcome|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816680|NCT01339299|E2|Reported Event|Recombinant Luteinizing Hormone|"150 IU r-LH, recombinant luteinising hormone, from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14)~recombinant luteinizing hormone (r-LH) : administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816681|NCT01339299|E1|Reported Event|Recombinant Human Chorionic Gonadotrofin|"25 IU of r-hCG from treatment day 1 (stimulation day 1) until day of r-hCG administration (normally treatment day 10 to 14 )~recombinant human chorionic gonadotropin (r-hCG) : administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)"
816686|NCT01339260|P1|Participant Flow|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
816687|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
816688|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
816689|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
816690|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
816691|NCT01339260|O2|Outcome|Palonosetron Plus Dexamethasone|"Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle~Palonosetron~Dexamethasone"
816692|NCT01339260|O1|Outcome|Netupitant and Palonosetron Plus Dexamethasone|"Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle~Netupitant and Palonosetron~Dexamethasone"
816693|NCT01339260|E4|Reported Event|Palonosetron+Dexamethasone-multicycle Extension|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
816694|NCT01339260|E3|Reported Event|Netupitant and Palonosetron+Dexamethasone-multicycle Extension|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
816695|NCT01339260|E2|Reported Event|Palonosetron+Dexamethasone-cycle 1|Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone (20 mg) both given on Day 1, prior to each scheduled chemotherapy cycle
816696|NCT01339260|E1|Reported Event|Netupitant and Palonosetron+Dexamethasone-cycle 1|Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone (12 mg), both given on Day 1, prior to each scheduled chemotherapy cycle
816697|NCT01339247|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga – Canada in Period 1; followed by reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in Period 1 and test product in Period 2
816698|NCT01339247|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1; followed by test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
817569|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
816706|NCT01339247|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
816707|NCT01339247|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
816708|NCT01339091|B3|Baseline|Total|Total of all reporting groups
816709|NCT01339091|B2|Baseline|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
816710|NCT01339091|B1|Baseline|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
816711|NCT01339091|P2|Participant Flow|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
816712|NCT01339091|P1|Participant Flow|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
816713|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
816714|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
816715|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
816716|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
816717|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
816718|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
817684|NCT01335191|B3|Baseline|Total|Total of all reporting groups
816719|NCT01339091|O2|Outcome|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
816720|NCT01339091|O1|Outcome|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
816721|NCT01339091|E2|Reported Event|Vancomycin +/- Oral Linezolid|Vancomycin : IV Vancomycin (dosed per standard of care) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
816722|NCT01339091|E1|Reported Event|Dalbavancin|Dalbavancin : IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
816723|NCT01339052|B3|Baseline|Total|Total of all reporting groups
816724|NCT01339052|B2|Baseline|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816725|NCT01339052|B1|Baseline|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816726|NCT01339052|P2|Participant Flow|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816727|NCT01339052|P1|Participant Flow|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816728|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816729|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816730|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816731|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816732|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816733|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816734|NCT01339052|O1|Outcome|Cohort I: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816735|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816736|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816737|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816738|NCT01339052|O1|Outcome|Cohort 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816739|NCT01339052|O1|Outcome|Cohort 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Participants continued treatment until disease progression or unacceptable toxicity."
816740|NCT01339052|E2|Reported Event|Cohorts 2: Non-surgical Subjects|"Subjects not candidates for surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
816741|NCT01339052|E1|Reported Event|Cohorts 1: Surgical Subjects|"Subjects scheduled for surgery~BKM120: 100 mg once daily, orally, for 8-12 days prior to surgery~Surgery: Surgery~BKM120: 100 mg once daily, orally, for 28-day cycles~Patients continued treatment until disease progression or unacceptable toxicity."
816742|NCT01339013|B1|Baseline|All Study Participants|Heat and Moisture Exchanger, then AnaConDa, finally Heat and Moisture Exchanger
816743|NCT01339013|P1|Participant Flow|AnaConDa Replaces the Heat and Moisture Exchanger|The conventional Heat and Moisture Exchanger is replaced by the AnaConDa which in turn is replaced by the conventional Heat and Moisture Exchanger.
816744|NCT01339013|O1|Outcome|AnaConDa|Anesthetic Conserving Device (AnaConDa) has a charcoal filter.
816745|NCT01339013|E1|Reported Event|AnaConDa|Anesthetic Conserving Device (AnaConDa or ACD) has a charcoal filter.
816746|NCT01339000|B3|Baseline|Total|Total of all reporting groups
816769|NCT01338870|B1|Baseline|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816770|NCT01338870|P6|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816747|NCT01339000|B2|Baseline|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816748|NCT01339000|B1|Baseline|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816749|NCT01339000|P2|Participant Flow|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816750|NCT01339000|P1|Participant Flow|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816751|NCT01339000|O2|Outcome|Arm B - Sequence Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816785|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816786|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816834|NCT01338818|E1|Reported Event|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
816752|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816753|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816754|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizationa|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816755|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816756|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816757|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816758|NCT01339000|O1|Outcome|Arm A -Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816759|NCT01339000|O2|Outcome|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816760|NCT01339000|O1|Outcome|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816761|NCT01339000|E2|Reported Event|Arm B - Sequence 2 Immunizations|"Receive vaccines of Sequence 2 first then vaccines of Sequence1, 7 weeks later, after receiving IL-7~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816762|NCT01339000|E1|Reported Event|Arm A - Sequence 1 Immunizations|"Receive vaccine of Sequence 1 first, then vaccines of Sequence 2, 7 weeks later, after receiving interleukin-7 (IL-7)~Glycosylated Recombinant Human Interleukin-7: Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection~Diphtheria/Tetanus Vaccine: Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.~Polio Vaccine: Polio Vaccine will be administered according to the randomized schedule per protocol.~Pneumococcal Vaccine: Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis A Vaccine: Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.~Hepatitis B Vaccine: Hepatitis B vaccine will be administered according to the randomization schedule per protocol."
816763|NCT01338870|B7|Baseline|Total|Total of all reporting groups
816764|NCT01338870|B6|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816765|NCT01338870|B5|Baseline|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816766|NCT01338870|B4|Baseline|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816767|NCT01338870|B3|Baseline|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816768|NCT01338870|B2|Baseline|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816926|NCT01337739|P1|Participant Flow|Placebo Comparator|Continuous infusion of placebo during operative procedure
816771|NCT01338870|P5|Participant Flow|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816772|NCT01338870|P4|Participant Flow|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816773|NCT01338870|P3|Participant Flow|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816774|NCT01338870|P2|Participant Flow|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816775|NCT01338870|P1|Participant Flow|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816776|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816777|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816778|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816779|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816780|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816781|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816782|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816783|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816784|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816872|NCT01338610|E1|Reported Event|Run-In|ESBA105 vehicle, all participants
816787|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816788|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816789|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816790|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816791|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816792|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816793|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816794|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816795|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816796|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816797|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816798|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816799|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816800|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816801|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816802|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816803|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816804|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816805|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816806|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816807|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816808|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816809|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816810|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816811|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816833|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
816812|NCT01338870|O6|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816813|NCT01338870|O5|Outcome|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816814|NCT01338870|O4|Outcome|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816815|NCT01338870|O3|Outcome|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816816|NCT01338870|O2|Outcome|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816817|NCT01338870|O1|Outcome|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816818|NCT01338870|E6|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg tablet orally once daily as morning dose and placebo matched to sitagliptin tablet orally once daily as evening dose along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816819|NCT01338870|E5|Reported Event|PF-04991532 300 mg|PF-04991532 300 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816820|NCT01338870|E4|Reported Event|PF-04991532 150 mg|PF-04991532 150 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816821|NCT01338870|E3|Reported Event|PF-04991532 75 mg|PF-04991532 75 mg tablet orally twice daily along background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816822|NCT01338870|E2|Reported Event|PF-04991532 25 mg|PF-04991532 25 mg tablet orally twice daily along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816823|NCT01338870|E1|Reported Event|Placebo|Placebo matched to PF-04991532 tablets orally twice daily or placebo matched to sitagliptin tablet orally twice daily along with background metformin 500 milligram (mg) immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
816824|NCT01338857|B1|Baseline|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
816825|NCT01338857|P1|Participant Flow|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
816826|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
816827|NCT01338857|O1|Outcome|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
816828|NCT01338857|E1|Reported Event|Sorafenib (Nexavar)|"Sorafenib will be administered orally BID (approximately every 12 hours). A cycle is 28 days w/o interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment) to a maximum of 400 mg PO twice daily~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily~NF1 patients: 80mg/m2/dose PO 2x daily to max of 150mg PO 2x daily."
816829|NCT01338818|B1|Baseline|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
816830|NCT01338818|P1|Participant Flow|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
816831|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
816832|NCT01338818|O1|Outcome|Ritalin LA|All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40, 60 or 80 mg/day).
817610|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
816835|NCT01338792|B1|Baseline|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
816836|NCT01338792|P1|Participant Flow|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
816837|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
816838|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
816839|NCT01338792|O1|Outcome|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
816840|NCT01338792|E1|Reported Event|Treatment (Chemotherapy and Enzyme Inhibitor)|Patients receive oxaliplatin IV over 2 hours and pemetrexed disodium IV on day 1. Courses repeat every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
816841|NCT01338649|B3|Baseline|Total|Total of all reporting groups
816842|NCT01338649|B2|Baseline|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
816843|NCT01338649|B1|Baseline|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
816844|NCT01338649|P2|Participant Flow|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
816845|NCT01338649|P1|Participant Flow|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
816927|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
816846|NCT01338649|O2|Outcome|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
816847|NCT01338649|O1|Outcome|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
816848|NCT01338649|E2|Reported Event|Dim Red Light|"Dim red light control group.~Dim red light (Sun Ray Sunbox SB-558): Dim red light box administered during two 1 hour periods during the day using"
816849|NCT01338649|E1|Reported Event|Bright White|"Bright white light treatment group.~Bright Light Treatment (Sun Ray Sunbox SB-558): Bright white light box using light intensity of 10,000 lux, administered during two 1 hour periods during the day."
816850|NCT01338636|B1|Baseline|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816851|NCT01338636|P1|Participant Flow|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816852|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816853|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816854|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816855|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816856|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816857|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816858|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816859|NCT01338636|O1|Outcome|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816860|NCT01338636|E1|Reported Event|Exercise-induced PAH|Ambrisentan 5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
816861|NCT01338610|B4|Baseline|Total|Total of all reporting groups
816862|NCT01338610|B3|Baseline|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
816863|NCT01338610|B2|Baseline|ESBA105|ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
816864|NCT01338610|B1|Baseline|Run-In Only|ESBA105 vehicle
816865|NCT01338610|P3|Participant Flow|Vehicle|ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment)
816866|NCT01338610|P2|Participant Flow|ESBA105|ESBA105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment)
816867|NCT01338610|P1|Participant Flow|Run-In Only|ESBA105 vehicle
816868|NCT01338610|O2|Outcome|Vehicle|ESBA105 vehicle
816869|NCT01338610|O1|Outcome|ESBA105|ESBA105 ophthalmic solution
816870|NCT01338610|E3|Reported Event|Vehicle|ESBA105 vehicle
816871|NCT01338610|E2|Reported Event|ESBA105|ESBA105 ophthalmic solution
816873|NCT01338493|B1|Baseline|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
816874|NCT01338493|P1|Participant Flow|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
816875|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
816876|NCT01338493|O1|Outcome|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
816877|NCT01338493|E1|Reported Event|Lumbar Spinal Arthroplasty + Maverick™|"Patients requiring total disc replacement~lumbar spinal arthroplasty + Maverick™: All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc."
816878|NCT01338025|B3|Baseline|Total|Total of all reporting groups
816928|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
816929|NCT01337739|O2|Outcome|Active Comparator|Administration of Dexmedetomidine
816930|NCT01337739|O1|Outcome|Placebo Comparator|Continuous infusion of placebo during operative procedure
816879|NCT01338025|B2|Baseline|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
816880|NCT01338025|B1|Baseline|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
816881|NCT01338025|P2|Participant Flow|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects were randomized to receive 3TC or FTC (the choice of 3TC or FTC was left to the provider.) In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.)"
816882|NCT01338025|P1|Participant Flow|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects were randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects either began a new HAART regimen, continue randomized treatment, or discontinued therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider."
816883|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
816884|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
816885|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
816886|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
816887|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
816888|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
816946|NCT01337674|O4|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
816889|NCT01338025|O2|Outcome|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~3TC or FTC monotherapy: The study participant will be assigned to either 3TC/FTC monotherapy (the choice of 3TC or FTC will be left to the provider."
816890|NCT01338025|O1|Outcome|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider.~HAART regimen: The study participant will continue their non-suppressive HAART regimen as prescribed by their primary provider."
816891|NCT01338025|E2|Reported Event|Arm B, 3TC or FTC Monotherapy|"In step 1, subjects will be randomized to receive 3TC or FTC (the choice of 3TC or FTC will be left to the provider).~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
816892|NCT01338025|E1|Reported Event|Arm A, Non-suppressive HAART Regimen|"In Step 1, subjects will be randomized to continue their non-suppressive HAART regimen as prescribed by their primary provider.~In Step 2, subjects will either begin a new HAART regimen, continue randomized treatment, or discontinue therapy while remaining on follow-up, as decided by their provider."
816893|NCT01338012|B1|Baseline|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
816894|NCT01338012|P1|Participant Flow|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
816895|NCT01338012|O1|Outcome|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
816896|NCT01338012|E1|Reported Event|Sipuleucel-T|Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
816897|NCT01337960|B4|Baseline|Total|Total of all reporting groups
816898|NCT01337960|B3|Baseline|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
816899|NCT01337960|B2|Baseline|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816900|NCT01337960|B1|Baseline|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816901|NCT01337960|P3|Participant Flow|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
816902|NCT01337960|P2|Participant Flow|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816903|NCT01337960|P1|Participant Flow|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816904|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
816905|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816931|NCT01337739|E2|Reported Event|Active Comparator|Administration of Dexmedetomidine
816932|NCT01337739|E1|Reported Event|Placebo Comparator|Continuous infusion of placebo during operative procedure
816933|NCT01337674|B3|Baseline|Total|Total of all reporting groups
818115|NCT01333397|O3|Outcome|Dysport NG 50 U|
816906|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816907|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
816908|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816909|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816910|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
817853|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
816911|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816912|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816913|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
816934|NCT01337674|B2|Baseline|Panel B Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
817126|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
816914|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816915|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816916|NCT01337960|O3|Outcome|Treadmill Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
816917|NCT01337960|O2|Outcome|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816947|NCT01337674|O3|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
816948|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
817375|NCT01335997|E1|Reported Event|Seq 1 (Periods I+II): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT/SIMVA 1 g/10 mg for 4 weeks (Period I) followed by ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period II)
816918|NCT01337960|O1|Outcome|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816919|NCT01337960|E3|Reported Event|Trll Only (TMO)|"Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.~Treadmill Only (TMO): Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period."
816920|NCT01337960|E2|Reported Event|Treadmill Robot Training (TMR)|"Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Treadmill Locomotor-based Training (TMR): Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816921|NCT01337960|E1|Reported Event|Seated Robot Training (SRT)|"Seated robot training group. Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.~Seated Robot Training (SRT): Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training."
816922|NCT01337739|B3|Baseline|Total|Total of all reporting groups
816923|NCT01337739|B2|Baseline|Active Comparator|Administration of Dexmedetomidine
816924|NCT01337739|B1|Baseline|Placebo Comparator|Continuous infusion of placebo during operative procedure
816925|NCT01337739|P2|Participant Flow|Active Comparator|Administration of Dexmedetomidine
817685|NCT01335191|B2|Baseline|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
816935|NCT01337674|B1|Baseline|Panel A Participants|Once daily oral dose of MK-4618 (two 50-mg tablets) or placebo (two tablets) on Days 1 through 7 in Period 1 followed by the crossover treatment in Period 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
816936|NCT01337674|P4|Participant Flow|Panel B: PBO + Amlo → MK-4618 + Amlo|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
816937|NCT01337674|P3|Participant Flow|Panel B: MK-4618 + Amlo → PBO + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of amlodipine (Amlo) for the duration of the study. A 2-week washout period follows Period 1.
816938|NCT01337674|P2|Participant Flow|Panel A: PBO + Met → MK-4618 + Met|Once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 1 followed by MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
816939|NCT01337674|P1|Participant Flow|Panel A: MK-4618 + Met → PBO + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) on Days 1 through 7 in Period 1 followed by once daily oral dose of placebo (two tablets) on Days 1 through 7 in Period 2. Participants receive previously prescribed daily dose of metoprolol (Met) for the duration of the study. A 2-week washout period follows Period 1.
816940|NCT01337674|O2|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
816941|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
816942|NCT01337674|O2|Outcome|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
816943|NCT01337674|O1|Outcome|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
816944|NCT01337674|O2|Outcome|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
816945|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
816949|NCT01337674|O1|Outcome|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
816950|NCT01337674|E4|Reported Event|Panel B: PBO + Amlo|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
816951|NCT01337674|E3|Reported Event|Panel B: MK-4618 + Amlo|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of amlodipine for the duration of the study. A 2-week washout period follows Period 1.
816952|NCT01337674|E2|Reported Event|Panel A: PBO + Met|Once daily oral dose of placebo (two tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
816953|NCT01337674|E1|Reported Event|Panel A: MK-4618 + Met|Once daily oral dose of MK-4618 (two 50-mg tablets) in Period 1 or 2. Participants receive previously prescribed daily dose of metoprolol for the duration of the study. A 2-week washout period follows Period 1.
816954|NCT01337635|B3|Baseline|Total|Total of all reporting groups
816955|NCT01337635|B2|Baseline|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
816956|NCT01337635|B1|Baseline|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
816957|NCT01337635|P2|Participant Flow|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
816958|NCT01337635|P1|Participant Flow|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
816959|NCT01337635|O2|Outcome|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
816960|NCT01337635|O1|Outcome|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
817397|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
816961|NCT01337635|E2|Reported Event|High Dose Vitamin D|"Treatment with ergocalciferol 300,000 IU (6 capsules of 50,000 IU) as a single oral dose observed in clinic.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
816962|NCT01337635|E1|Reported Event|Standard Dose Vitamin D|"Treatment with cholecalciferol 400 IU daily at home.~Vitamin D: Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks"
816963|NCT01337609|B4|Baseline|Total|Total of all reporting groups
816964|NCT01337609|B3|Baseline|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
816965|NCT01337609|B2|Baseline|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
816966|NCT01337609|B1|Baseline|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
816967|NCT01337609|P3|Participant Flow|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
816968|NCT01337609|P2|Participant Flow|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
816969|NCT01337609|P1|Participant Flow|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
816970|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
816971|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
816972|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
816973|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
816974|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
816975|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
816976|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
816977|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
816978|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
816979|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
816980|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
816981|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
816982|NCT01337609|O3|Outcome|Ganeden BC30, Sugar Pill|Arm 3 will take placebo (sugar pill) for 30 days, followed by Ganeden BC30 for 30 days.
816983|NCT01337609|O2|Outcome|Sugar Pill|Arm 2 will take placebo (sugar pill) for 60 days.
816984|NCT01337609|O1|Outcome|GanedenBC30|Arm 1 will take GanedenBC30 (Bacillus coagulans GBI-30, 6086, 1 capsule/day) for 60 days.
816985|NCT01337609|E3|Reported Event|Placebo for 30 Days, Followed by GanedenBC30 for 30 Days|
816986|NCT01337609|E2|Reported Event|GanedenBC30 for 60 Days|
816987|NCT01337609|E1|Reported Event|Placebo for 60 Days|
816988|NCT01337336|B3|Baseline|Total|Total of all reporting groups
816989|NCT01337336|B2|Baseline|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
816990|NCT01337336|B1|Baseline|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
817376|NCT01335971|B4|Baseline|Total|Total of all reporting groups
816991|NCT01337336|P2|Participant Flow|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
816992|NCT01337336|P1|Participant Flow|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
816993|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
816994|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
816995|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
816996|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
816997|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
816998|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
816999|NCT01337336|O2|Outcome|AC Cohort|Anticholinergics (AC) include Tiotropium, Ipratropium, and Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
817000|NCT01337336|O1|Outcome|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
817001|NCT01337336|E2|Reported Event|AC Cohort|Anticholinergics (AC) include iotropium, and Ipratropium, Ipratropium-albuterol combination drug product. Due to the retrospective nature of this study, dosing information is not available.
817002|NCT01337336|E1|Reported Event|FSC Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
817003|NCT01337297|B3|Baseline|Total|Total of all reporting groups
817004|NCT01337297|B2|Baseline|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817398|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817005|NCT01337297|B1|Baseline|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817006|NCT01337297|P2|Participant Flow|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817007|NCT01337297|P1|Participant Flow|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817008|NCT01337297|O2|Outcome|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817009|NCT01337297|O1|Outcome|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817010|NCT01337297|E2|Reported Event|Sham-tDCS|"the electrodes are positioned in the same manner as the active-tDCS, activated for 20 s (time to climb ramp of the current until reach the current intensity used in the experiment), enough to produce the sensation of itch, and turned off until the end of the session.~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817011|NCT01337297|E1|Reported Event|Active-tDCS|"low-intensity transcranial Direct Current Stimulation (tDCS)applied over the dorsolateral prefrontal cortex~transcranial Direct Current Stimulation : transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site)."
817012|NCT01337167|B3|Baseline|Total|Total of all reporting groups
817013|NCT01337167|B2|Baseline|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817176|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817014|NCT01337167|B1|Baseline|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817015|NCT01337167|P2|Participant Flow|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817016|NCT01337167|P1|Participant Flow|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817017|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817018|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817019|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817020|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817021|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817022|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817023|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817024|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817025|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817026|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817027|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817028|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817029|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817030|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817031|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817032|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817033|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817034|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817035|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817854|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
817036|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817037|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817038|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817039|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817040|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817041|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817042|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817043|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817044|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817045|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817399|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817046|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817047|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817048|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817049|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817050|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817051|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817052|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817053|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817054|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817055|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817056|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817057|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817058|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817059|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817060|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817061|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817062|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817063|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817064|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817065|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817066|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817067|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817400|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
818116|NCT01333397|O2|Outcome|Dysport NG 20 U|
817068|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817069|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817070|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817071|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817072|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817073|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817074|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817075|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817076|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817077|NCT01337167|O2|Outcome|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817078|NCT01337167|O1|Outcome|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817079|NCT01337167|E2|Reported Event|Control|Pentacel™ 0.5 mL IM at 2, 4, and 6 months of age; Recombivax HB vaccine 0.5 mL IM at 2 and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; ActHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817080|NCT01337167|E1|Reported Event|V419|V419 0.5 mL intramuscular injection (IM) at 2, 4, and 6 months of age; Daptacel™ 0.5 mL IM at 15 months of age; PedvaxHIB™ 0.5 mL IM at 15 months of age; Prevnar 13™ 0.5 mL IM at 2, 4, 6, and 15 months of age; and RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age.
817081|NCT01337115|B3|Baseline|Total|Total of all reporting groups
817082|NCT01337115|B2|Baseline|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
817083|NCT01337115|B1|Baseline|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
817084|NCT01337115|P2|Participant Flow|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
817085|NCT01337115|P1|Participant Flow|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
817086|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
817087|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
817088|NCT01337115|O2|Outcome|CFNB+Single Shot SNB|Patients with additional sciatic nerve block
817089|NCT01337115|O1|Outcome|CFNB|Patients with continuous femoral nerve block
817090|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
817091|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
817092|NCT01337115|O2|Outcome|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
817093|NCT01337115|O1|Outcome|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
818117|NCT01333397|O1|Outcome|Placebo|
817094|NCT01337115|E2|Reported Event|Single Shot Sciatic Nerve Block (SNB)|A single shot sciatic nerve block is performed before surgery with 25ml of 0.2% ropivacaine in addition to the continuous femoral nerve block performed in the control group
817095|NCT01337115|E1|Reported Event|Continuous Femoral Nerve Block (CFNB)|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in PACU and maintained for 48h
817096|NCT01337076|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
817097|NCT01337076|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
817098|NCT01337076|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
817099|NCT01337076|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint of 6 months postimplant activation
817100|NCT01337050|B4|Baseline|Total|Total of all reporting groups
817101|NCT01337050|B3|Baseline|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817102|NCT01337050|B2|Baseline|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817103|NCT01337050|B1|Baseline|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817104|NCT01337050|P3|Participant Flow|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817105|NCT01337050|P2|Participant Flow|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817106|NCT01337050|P1|Participant Flow|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817107|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817108|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817109|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817110|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817111|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817112|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817113|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817114|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817115|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817116|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817117|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817118|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817119|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817120|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817121|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817122|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817123|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817124|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817125|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817401|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817127|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817128|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817129|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817130|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817131|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817132|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817133|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817134|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817135|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817136|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817137|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817138|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817139|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817140|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817141|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817142|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817974|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817143|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817144|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817145|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817146|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817147|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817148|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817149|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817150|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817151|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817152|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817153|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817154|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817155|NCT01337050|O3|Outcome|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817156|NCT01337050|O2|Outcome|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817157|NCT01337050|O1|Outcome|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817158|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817159|NCT01337050|O1|Outcome|PF-03446962|PF-03446962 4.5, 7.0 or 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817160|NCT01337050|E3|Reported Event|PF-03446962 10.0 mg/kg|PF-03446962 10.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817161|NCT01337050|E2|Reported Event|PF-03446962 7.0 mg/kg|PF-03446962 7.0 mg/kg intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817162|NCT01337050|E1|Reported Event|PF-03446962 4.5 mg/kg|PF-03446962 4.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1 of each cycle. Cycle 1 was of 28 days duration and all subsequent cycles were of 14 days duration.
817163|NCT01336894|B3|Baseline|Total|Total of all reporting groups
817164|NCT01336894|B2|Baseline|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817165|NCT01336894|B1|Baseline|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817166|NCT01336894|P2|Participant Flow|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817167|NCT01336894|P1|Participant Flow|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817168|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817169|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817170|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817171|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817172|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817173|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817174|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817175|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817177|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817178|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817179|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817180|NCT01336894|O2|Outcome|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817181|NCT01336894|O1|Outcome|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817182|NCT01336894|E2|Reported Event|Arm II (SBRT)|Patients undergo 3 fractions of stereotactic body radiation therapy (SBRT) at 2-8 days apart.
817183|NCT01336894|E1|Reported Event|Arm I (SR+Brachytherapy)|Patients undergo sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy with or without intraoperative brachytherapy comprising an iodine I 125 implant at the resection margin.
817184|NCT01336764|B3|Baseline|Total|Total of all reporting groups
817185|NCT01336764|B2|Baseline|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
817186|NCT01336764|B1|Baseline|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
817187|NCT01336764|P2|Participant Flow|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
817188|NCT01336764|P1|Participant Flow|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
817189|NCT01336764|O2|Outcome|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
817402|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817403|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817190|NCT01336764|O1|Outcome|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
817191|NCT01336764|E2|Reported Event|Control|"Coping self statements and breathing retraining will be replaced with undirected passive behaviors such as listening to music.~Control: Unguided listening to radio/music."
817192|NCT01336764|E1|Reported Event|Active|"individual coping self-statements and stimulus guided paced breathing.~Cognitive reappraisal and breathing retraining: They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle."
817193|NCT01336738|B6|Baseline|Total|Total of all reporting groups
817194|NCT01336738|B5|Baseline|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817195|NCT01336738|B4|Baseline|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817196|NCT01336738|B3|Baseline|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817197|NCT01336738|B2|Baseline|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817198|NCT01336738|B1|Baseline|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817199|NCT01336738|P5|Participant Flow|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817200|NCT01336738|P4|Participant Flow|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817201|NCT01336738|P3|Participant Flow|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817202|NCT01336738|P2|Participant Flow|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817203|NCT01336738|P1|Participant Flow|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817204|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817205|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817206|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817207|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817208|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817209|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817210|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817404|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817211|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817212|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817213|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817214|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817215|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817216|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817217|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817218|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817219|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817220|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817221|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817975|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817222|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817223|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817224|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817225|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817226|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817227|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817228|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817229|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817230|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817405|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817406|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817231|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817232|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817233|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817234|NCT01336738|O5|Outcome|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817235|NCT01336738|O4|Outcome|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817236|NCT01336738|O3|Outcome|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817237|NCT01336738|O2|Outcome|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817238|NCT01336738|O1|Outcome|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817239|NCT01336738|E5|Reported Event|Placebo|Five placebo tablets matched to PF-04991532 150 mg and 1 placebo matched to sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817240|NCT01336738|E4|Reported Event|Sitagliptin 100 mg|Five placebo tablets matched to PF-04991532 150 mg and 1 sitagliptin 100 mg tablet orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817271|NCT01336608|B3|Baseline|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817241|NCT01336738|E3|Reported Event|PF-04991532 750 mg|PF-04991532 750 mg (5 PF-04991532 150 mg tablets) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817242|NCT01336738|E2|Reported Event|PF-04991532 450 mg|PF-04991532 450 mg (3 PF-04991532 150 mg tablets and 2 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817243|NCT01336738|E1|Reported Event|PF-04991532 150 mg|PF-04991532 150 milligram (mg) (1 PF-04991532 150 mg tablet and 4 placebo tablets matched to PF-04991532 150 mg) orally once daily and 1 placebo tablet matched to sitagliptin 100 mg orally once daily, along with background metformin 500 mg immediate release tablets or as per standard clinical practice (based on the dose prior to randomization), for 12 weeks.
817244|NCT01336712|B1|Baseline|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817245|NCT01336712|P1|Participant Flow|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4~Patient follow up x6 months"
817246|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817247|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817248|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817249|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817250|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817251|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817252|NCT01336712|O1|Outcome|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817253|NCT01336712|E1|Reported Event|Myeloablative Haploidentical Transplant|"Haplo transplant~Peripheral Blood Stem Cell Transplant: Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.~Fludarabine 30 mg/m2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
817254|NCT01336647|B4|Baseline|Total|Total of all reporting groups
817255|NCT01336647|B3|Baseline|Vehicle|Vehicle Gel without active ingredient of Ha44.
817256|NCT01336647|B2|Baseline|High-Dose Ha44|High-Dose Ha44 0.74% Gel, topically administered to hair and scalp for 10 minutes
817257|NCT01336647|B1|Baseline|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, topically administered to hair and scalp for 10 minutes
817258|NCT01336647|P3|Participant Flow|Vehicle|Vehicle Ha44 Gel with no active incident it was administered topically for 10 minutes as a single dose.
817259|NCT01336647|P2|Participant Flow|High-Dose Ha44|High-Dose Ha44 Gel 0.74% it was administered topically for 10 minutes as a single dose
817260|NCT01336647|P1|Participant Flow|Low Dose Ha 44 Gel|Low-Dose Ha44 Gel 0.37%, it was administered topically for 10 minutes as a single dose.
817261|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
817262|NCT01336647|O2|Outcome|High Dose Ha44|High-Dose Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
817263|NCT01336647|O1|Outcome|Low Dose Ha44|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
817264|NCT01336647|O3|Outcome|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
817265|NCT01336647|O2|Outcome|Hig Dose Ha44|Ha44 0.74% Gel administered topically to hair and scalp for 10 minutes.
817266|NCT01336647|O1|Outcome|Low Dose Ha44|Ha44 0.37% Gel administered topically to hair and scalp for 10 minutes.
817267|NCT01336647|E3|Reported Event|Vehicle|Vehicle Gel without active ingredient administered topically to hair and scalp for 10 minutes.
817268|NCT01336647|E2|Reported Event|High Dose Ha44 Gel|High-Dose Ha44 0.74% Gel, administered topically to hair and scalp for 10 minutes.
817269|NCT01336647|E1|Reported Event|Low Dose Ha44 Gel|Low-Dose Ha44 0.37% Gel, administered topically to hair and scalp for 10 minutes.
817270|NCT01336608|B4|Baseline|Total|Total of all reporting groups
817337|NCT01336140|E2|Reported Event|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
817272|NCT01336608|B2|Baseline|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817273|NCT01336608|B1|Baseline|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817274|NCT01336608|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received fluticasone furoate (FF)/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817275|NCT01336608|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 micrograms (µg) inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817276|NCT01336608|P2|Participant Flow|Placebo QD|Participants received placebo QD in the morning via a dry powder inhaler (DPI) for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817277|NCT01336608|P1|Participant Flow|Placebo-Run-in|Participants received placebo once daily (QD) in the morning for 2 weeks. In addition, participants were provided an inhaled short-acting beta2-receptor agonist (SABA), albuterol (salbutamol) (metered dose inhaler [MDI] or nebules), to be used as a rescue medication for relief of chronic obstructive pulmonary disease (COPD) symptoms during the Run-in and Treatment Periods.
817278|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817279|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817280|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817281|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817282|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817283|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817284|NCT01336608|O3|Outcome|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817285|NCT01336608|O2|Outcome|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817286|NCT01336608|O1|Outcome|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817287|NCT01336608|E3|Reported Event|FF/VI 100/25 µg QD|Participants received FF/VI 100/25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817288|NCT01336608|E2|Reported Event|VI 25 µg QD|Participants received VI 25 µg inhalation QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol), to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817289|NCT01336608|E1|Reported Event|Placebo QD|Participants received placebo QD in the morning via a DPI for 24 weeks. In addition, participants were provided an inhaled SABA, albuterol (salbutamol) , to be used as a rescue medication for relief of COPD symptoms during the Run-in and Treatment Periods.
817290|NCT01336569|B1|Baseline|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
817291|NCT01336569|P1|Participant Flow|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
817292|NCT01336569|O1|Outcome|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
817293|NCT01336569|E1|Reported Event|DuoTrav|Travoprost 0.004%/timolol maleate 0.5% fixed combination, one drop to the study eye nightly for up to 6 weeks
817294|NCT01336296|B3|Baseline|Total|Total of all reporting groups
817295|NCT01336296|B2|Baseline|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817296|NCT01336296|B1|Baseline|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817338|NCT01336140|E1|Reported Event|Aminophylline|75 mg of intravenous aminophylline.
817339|NCT01336023|B4|Baseline|Total|Total of all reporting groups
817297|NCT01336296|P2|Participant Flow|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817298|NCT01336296|P1|Participant Flow|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817299|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817300|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817301|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817302|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817303|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817304|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817305|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817306|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817307|NCT01336296|O2|Outcome|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817308|NCT01336296|O1|Outcome|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817309|NCT01336296|E2|Reported Event|Myfortic Standard|"Myfortic at time of transplant with Thymoglobulin induction~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817310|NCT01336296|E1|Reported Event|Myfortic Preload|"Initiation of Myfortic 2 weeks prior to transplantation (with Simulect induction at time of transplant)~mycophenolic acid: Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant"
817311|NCT01336205|B3|Baseline|Total|Total of all reporting groups
817312|NCT01336205|B2|Baseline|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
817313|NCT01336205|B1|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
817314|NCT01336205|P2|Participant Flow|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
817315|NCT01336205|P1|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
817316|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
817317|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
817318|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
817319|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
817320|NCT01336205|O2|Outcome|Usual Care|Laxative treatment regimen for OIC determined by the investigator according to his/her best clinical judgment.
817321|NCT01336205|O1|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
817322|NCT01336205|E2|Reported Event|Usual Care|
817323|NCT01336205|E1|Reported Event|NKTR-118 25 mg|
817324|NCT01336140|B3|Baseline|Total|Total of all reporting groups
817325|NCT01336140|B2|Baseline|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
817326|NCT01336140|B1|Baseline|Aminophylline|75 mg of intravenous aminophylline.
817327|NCT01336140|P2|Participant Flow|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
817328|NCT01336140|P1|Participant Flow|Aminophylline|75 mg of intravenous aminophylline.
817329|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
817330|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
817331|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
817332|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
817333|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
817334|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
817335|NCT01336140|O2|Outcome|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
817336|NCT01336140|O1|Outcome|Aminophylline|75 mg of intravenous aminophylline.
817340|NCT01336023|B3|Baseline|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817341|NCT01336023|B2|Baseline|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817342|NCT01336023|B1|Baseline|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817343|NCT01336023|P3|Participant Flow|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817344|NCT01336023|P2|Participant Flow|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817345|NCT01336023|P1|Participant Flow|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817346|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817347|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817348|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817349|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817350|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817351|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817352|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817353|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817354|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817976|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817355|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817356|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817357|NCT01336023|O3|Outcome|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817358|NCT01336023|O2|Outcome|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817359|NCT01336023|O1|Outcome|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817360|NCT01336023|E3|Reported Event|Liraglutide|Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817361|NCT01336023|E2|Reported Event|IDegLira|Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817671|NCT01335230|B1|Baseline|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
817362|NCT01336023|E1|Reported Event|IDeg|Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
817363|NCT01335997|B3|Baseline|Total|Total of all reporting groups
817364|NCT01335997|B2|Baseline|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
817365|NCT01335997|B1|Baseline|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
817366|NCT01335997|P2|Participant Flow|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
817367|NCT01335997|P1|Participant Flow|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
817368|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
817369|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
817370|NCT01335997|O2|Outcome|ERN/LRPT+SIM → ERN/LRPT/SIM (Sequence 2)|Study drug was co-administered as extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) (ERN/LRPT + SIM) during Periods I and II for 12 weeks and extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period III for 8 weeks.
817371|NCT01335997|O1|Outcome|ERN/LRPT/SIM → ERN/LRPT+SIM (Sequence 1)|Study drug was administered as extended-release niacin/laropiprant/simvastatin combination (ERN/LRPT/SIM) during Period I and II for 12 weeks and extended-release niacin/laropiprant (ERN/LRPT) + simvastatin (SIM) during Period III for 8 weeks.
817372|NCT01335997|E4|Reported Event|Seq 2 (Period III): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT/SIMVA 2 g/20 mg for 8 weeks (Period III)
817373|NCT01335997|E3|Reported Event|Seq 1 (Period III): ERN/LRPT/SIMVA → ERN/LRPT+SIMVA|ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period III)
817374|NCT01335997|E2|Reported Event|Seq 2 (Periods I+II): ERN/LRPT+SIM → ERN/LRPT/SIM|ERN/LRPT 1 g + SIMVA 10 mg for 4 weeks (Period I) followed by ERN/LRPT 2 g + SIMVA 20 mg for 8 weeks (Period II)
817855|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
817377|NCT01335971|B3|Baseline|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817378|NCT01335971|B2|Baseline|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817379|NCT01335971|B1|Baseline|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817380|NCT01335971|P3|Participant Flow|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817381|NCT01335971|P2|Participant Flow|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817382|NCT01335971|P1|Participant Flow|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817383|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817384|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817385|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817386|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817387|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817388|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817389|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817390|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817391|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817392|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817393|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817394|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817395|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817396|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817407|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817408|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817409|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817410|NCT01335971|O3|Outcome|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817411|NCT01335971|O2|Outcome|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817412|NCT01335971|O1|Outcome|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817413|NCT01335971|E3|Reported Event|Sulforaphane 150|"150 micromoles (26.6 mg) sulforaphane daily by mouth~Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth"
817414|NCT01335971|E2|Reported Event|Sulforaphane 25|"25 micromoles (4.4 mg) sulforaphane daily by mouth~Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth"
817415|NCT01335971|E1|Reported Event|Placebo|"Microcrystalline cellulose~Placebo: Microcrystalline cellulose once daily by mouth"
817416|NCT01335867|B3|Baseline|Total|Total of all reporting groups
817417|NCT01335867|B2|Baseline|Placebo|Placebo: Placebo pills
817418|NCT01335867|B1|Baseline|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
817419|NCT01335867|P2|Participant Flow|Placebo|Placebo: Placebo pills
817420|NCT01335867|P1|Participant Flow|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
817421|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
817422|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
817423|NCT01335867|O2|Outcome|Placebo|Placebo: Placebo pills
817424|NCT01335867|O1|Outcome|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
817425|NCT01335867|E2|Reported Event|Placebo|Placebo: Placebo pills
817426|NCT01335867|E1|Reported Event|Vigabatrin|Vigabatrin: Vigabatrin escalated to 3 grams daily for 8 weeks
817427|NCT01335789|B3|Baseline|Total|Total of all reporting groups
817428|NCT01335789|B2|Baseline|Saline|"intranasal administration~Saline: 40 IUs"
817429|NCT01335789|B1|Baseline|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
817430|NCT01335789|P2|Participant Flow|Saline|"intranasal administration~Saline: 40 IUs"
817431|NCT01335789|P1|Participant Flow|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
817432|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
817433|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
817434|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
817435|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
817436|NCT01335789|O2|Outcome|Saline|"intranasal administration~Saline: 40 IUs"
817437|NCT01335789|O1|Outcome|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
817438|NCT01335789|E2|Reported Event|Saline|"intranasal administration~Saline: 40 IUs"
817439|NCT01335789|E1|Reported Event|Oxytocin|"intranasal administration~Oxytocin: 40 IUs"
817856|NCT01334229|E2|Reported Event|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
817440|NCT01335750|B1|Baseline|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
817441|NCT01335750|P1|Participant Flow|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
817442|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
817443|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
817444|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
817445|NCT01335750|O1|Outcome|Multipurpose Solution #1|Optifree Replenish
817446|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline solution
817447|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
817448|NCT01335750|O2|Outcome|Multipurpose Solution #2|B&L Renu Fresh Multipurpose Solution
817449|NCT01335750|O1|Outcome|Mutlipurpose Solution #1|Optifree Replenish Multipurpose Solution
817450|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Solution
817451|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
817452|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
817453|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
817454|NCT01335750|O4|Outcome|Multipurpose Solution #4|Saline Multipurpose Solution
817455|NCT01335750|O3|Outcome|Multipurpose Solution #3|Ciba ClearCare Multipurpose Solution
817456|NCT01335750|O2|Outcome|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
817457|NCT01335750|O1|Outcome|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
817458|NCT01335750|E1|Reported Event|Multipurpose Solution|To obtain results of a clinical comparison of several multipurpose contact lens solutions among adapted hydrogel lens users wearing Avaira contact lenses
817459|NCT01335724|B3|Baseline|Total|Total of all reporting groups
817460|NCT01335724|B2|Baseline|Placebo Gel|
817461|NCT01335724|B1|Baseline|Diclofenac Diethylamine 1.16% Gel|
817462|NCT01335724|P2|Participant Flow|Placebo Gel|
817463|NCT01335724|P1|Participant Flow|Diclofenac Diethylamine 1.16% Gel|
817464|NCT01335724|O2|Outcome|Placebo Gel|
817465|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
817466|NCT01335724|O2|Outcome|Placebo Gel|
817467|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
817468|NCT01335724|O2|Outcome|Placebo Gel|
817469|NCT01335724|O1|Outcome|Diclofenac Diethylamine 1.16% Gel|
817470|NCT01335724|E2|Reported Event|Placebo Gel|
817471|NCT01335724|E1|Reported Event|Diclofenac Diethylamine 1.16% Gel|
817472|NCT01335698|B6|Baseline|Total|Total of all reporting groups
817473|NCT01335698|B5|Baseline|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817474|NCT01335698|B4|Baseline|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817475|NCT01335698|B3|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817476|NCT01335698|B2|Baseline|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817477|NCT01335698|B1|Baseline|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817478|NCT01335698|P5|Participant Flow|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817479|NCT01335698|P4|Participant Flow|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817480|NCT01335698|P3|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817481|NCT01335698|P2|Participant Flow|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817482|NCT01335698|P1|Participant Flow|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817483|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817484|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817485|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
818118|NCT01333397|O4|Outcome|Dysport NG 75 U|
817486|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817487|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817488|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817489|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817490|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817491|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817492|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817493|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817494|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817495|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817496|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817497|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817498|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817672|NCT01335230|P4|Participant Flow|10 Control Subjects|10 subjects without HIV, HCV, or both
817499|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817500|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817501|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817502|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817503|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets,100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817504|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817505|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817506|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817507|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817508|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817509|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817510|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817511|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817673|NCT01335230|P3|Participant Flow|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
817512|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817513|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817514|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817515|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817516|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817517|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817518|NCT01335698|O5|Outcome|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817519|NCT01335698|O4|Outcome|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817520|NCT01335698|O3|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817521|NCT01335698|O2|Outcome|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817522|NCT01335698|O1|Outcome|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817523|NCT01335698|E5|Reported Event|Atazanavir, 300 mg + Ritonavir, 100 mg (Weight: 25 to <35 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 300 mg, with ritozinavir capsule/tablets, 100 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817524|NCT01335698|E4|Reported Event|Atazanavir, 250 mg + Ritonavir, 80 mg (Weight: 15 to <25 kg)|Stage 1: HIV-infected pediatric patients weighing 15 to <25 kg at baseline received atazanir powder formulation, 250 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks.Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817674|NCT01335230|P2|Participant Flow|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
817525|NCT01335698|E3|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 10 to <15 kg)|Stage 1: HIV-infected pediatric patients weighing 10 to <15 kg at baseline received atazanir powder formulation, 200 mg, with ritozinavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817526|NCT01335698|E2|Reported Event|Atazanavir, 200 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 200 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817527|NCT01335698|E1|Reported Event|Atazanavir, 150 mg + Ritonavir, 80 mg (Weight: 5 to <10 kg)|Stage 1: HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. HIV-infected pediatric patients weighing 5 to <10 kg at baseline received atazanir powder formulation, 150 mg, with ritonavir oral solution, 80 mg, for 24 to 48 weeks. Patients entering Stage 2 continued Stage 1 treatment but those aged 12 years or older or weighing at least 35 kg transitioned to capsules. Treatment continued until the patient reached 18 years of age or pediatric indication is locally approved and patient meets requirements to receive appropriate formulation.
817528|NCT01335542|B3|Baseline|Total|Total of all reporting groups
817529|NCT01335542|B2|Baseline|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
817530|NCT01335542|B1|Baseline|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
817531|NCT01335542|P2|Participant Flow|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
817532|NCT01335542|P1|Participant Flow|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
817568|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817533|NCT01335542|O2|Outcome|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
817534|NCT01335542|O1|Outcome|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
817535|NCT01335542|E2|Reported Event|Local Infiltration|meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
817536|NCT01335542|E1|Reported Event|Epidural Pathway|meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
817537|NCT01335477|B3|Baseline|Total|Total of all reporting groups
817538|NCT01335477|B2|Baseline|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817539|NCT01335477|B1|Baseline|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817540|NCT01335477|P2|Participant Flow|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817541|NCT01335477|P1|Participant Flow|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817542|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817543|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817544|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817545|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817546|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817547|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817675|NCT01335230|P1|Participant Flow|10 HIV Mono-infected Subjects|10 subjects infected with HIV only
817548|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817549|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817550|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817551|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817552|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817553|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817554|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817555|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817556|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817557|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817558|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817559|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817560|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817561|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817562|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817563|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817564|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817565|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817566|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817567|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817570|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817571|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817572|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817573|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817574|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817575|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817576|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817577|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817578|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817579|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817580|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817581|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817582|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817583|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817584|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817585|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817586|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817587|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817676|NCT01335230|O4|Outcome|10 Control Subjects|10 subjects without HIV, HCV, or both
817588|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817589|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817590|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817591|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817592|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817593|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817594|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817595|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817596|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817597|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817598|NCT01335477|O2|Outcome|Nintedanib 150 mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817599|NCT01335477|O1|Outcome|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules
817600|NCT01335477|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
817601|NCT01335477|E1|Reported Event|Placebo|Oral administration of Placebo matching nintedanib soft gelatine capsules.
817602|NCT01335464|B3|Baseline|Total|Total of all reporting groups
817603|NCT01335464|B2|Baseline|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817604|NCT01335464|B1|Baseline|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817605|NCT01335464|P2|Participant Flow|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817606|NCT01335464|P1|Participant Flow|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817607|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817608|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817609|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817611|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817612|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817613|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817614|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817615|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817616|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817617|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817618|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817619|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817620|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817621|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817622|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817623|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817624|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817625|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817626|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817627|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817628|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817629|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817630|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817631|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817632|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817633|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817634|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817635|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817636|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817637|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817638|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817639|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817640|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817641|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817642|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817643|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817644|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817645|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817646|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817647|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817648|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817649|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817650|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817857|NCT01334229|E1|Reported Event|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
817651|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817652|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817653|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817654|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817655|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817656|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817657|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817658|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817659|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817660|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817661|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817662|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817663|NCT01335464|O2|Outcome|Nintedanib 150mg Bid|"Oral administration of soft gelatine capsules of nintedanib 150mg twice daily (bid).~Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events."
817664|NCT01335464|O1|Outcome|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules
817665|NCT01335464|E2|Reported Event|Nintedanib 150mg Bid|Oral administration of soft gelatine capsules of Nintedanib 150 mg twice daily (bid). Dose interruption and reduction to 100 mg bid dose were allowed to manage adverse events.
817666|NCT01335464|E1|Reported Event|Placebo|Oral administration of placebo matching nintedanib soft gelatine capsules.
817667|NCT01335230|B5|Baseline|Total|Total of all reporting groups
817668|NCT01335230|B4|Baseline|10 Control Subjects|10 subjects without HIV, HCV, or both
817669|NCT01335230|B3|Baseline|10 HIV/HCV Co-infected Subjects|10 subjects infected with both HIV and HCV
817670|NCT01335230|B2|Baseline|10 HCV Mono-infected Subjects|10 subjects infected with HCV only
817688|NCT01335191|P1|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
817689|NCT01335191|O2|Outcome|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
817690|NCT01335191|O1|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
817691|NCT01335191|E2|Reported Event|Placebo|Two subcutaneous injections of placebo at Day 0 and Week 3.
817692|NCT01335191|E1|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0 and Week 3.
817693|NCT01335061|B1|Baseline|All Participants|The data for all the participants is presented.
817694|NCT01335061|P1|Participant Flow|All Participants|The data for all the participants is presented.
817695|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
817696|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
817697|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
817698|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
817699|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
817700|NCT01335061|O1|Outcome|All Participants|The data for all the participants is presented.
817701|NCT01335061|O1|Outcome|All Population|The data for all the participants is presented.
817702|NCT01335061|O2|Outcome|On-Demand Therapy-Follow-up Infusions|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
817703|NCT01335061|O1|Outcome|On-Demand Therapy-First Infusion|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
817704|NCT01335061|O2|Outcome|Prophylaxis Therapy|The prophylaxis regimen of approximately 100 IU/kg once weekly was initiated at Visit 4.
817705|NCT01335061|O1|Outcome|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
817706|NCT01335061|E2|Reported Event|Prophylaxis Therapy|The prophylaxis regimen of approximately 100IU/kg once weekly was initiated at Visit 4.
817707|NCT01335061|E1|Reported Event|On-Demand Therapy|Participants were treated for the bleeding events at the discretion of the study physician according to BeneFIX label.
817708|NCT01334957|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817709|NCT01334957|P1|Participant Flow|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period. A minimum of one dose of intravenous ibuprofen will be administered. At the discretion of the investigator, up to three additional doses of 800 mg intravenous ibuprofen may be administered at six hour intervals.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817710|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817711|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817712|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817713|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817714|NCT01334957|O1|Outcome|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817715|NCT01334957|E1|Reported Event|Intravenous Ibuprofen|"Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 10 minute Treatment Period.~Intravenous ibuprofen: 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817716|NCT01334944|B1|Baseline|Intravenous Ibuprofen|"Intravenous ibuprofen (400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.~Intravenous ibuprofen: 400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes"
817717|NCT01334944|P2|Participant Flow|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
817718|NCT01334944|P1|Participant Flow|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
817719|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817720|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817749|NCT01334918|O1|Outcome|CTP: 0 Fixed Defects|Participants with zero fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
818119|NCT01333397|O3|Outcome|Dysport NG 50 U|
817721|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
817722|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
817723|NCT01334944|O1|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
817724|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
817725|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817726|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817727|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817728|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817729|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817730|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817731|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
817732|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
817733|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817734|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817735|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817858|NCT01334216|B3|Baseline|Total|Total of all reporting groups
817736|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period.
817737|NCT01334944|O2|Outcome|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
817738|NCT01334944|O1|Outcome|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
817739|NCT01334944|E2|Reported Event|Pain|Intravenous ibuprofen (800 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to three additional doses of 800 mg (every six hours), as determined by the investigator
817740|NCT01334944|E1|Reported Event|Fever|Intravenous ibuprofen (400 mg intravenous ibuprofen administered intravenously over 5-10 minutes) will be administered as a single dose during the 5-10 minute Treatment Period. Patients may receive up to five additional doses of 400 mg (every four hours), as determined by the investigator
817741|NCT01334918|B3|Baseline|Total|Total of all reporting groups
817742|NCT01334918|B2|Baseline|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
817743|NCT01334918|B1|Baseline|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
817744|NCT01334918|P2|Participant Flow|Sequence 2: MDCT - SPECT|"Day 1: a regadenoson stress CTP and a rest CCTA/CTP procedure.~Day 2: a rest SPECT and a regadenoson stress SPECT procedure. Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
817745|NCT01334918|P1|Participant Flow|Sequence 1: SPECT - MDCT|"Day 1: a rest Single Photon Emission Computed Tomography (SPECT) and a regadenoson stress SPECT procedure.~Day 2: a regadenoson stress Computed Tomography Perfusion (CTP) and a rest Coronary Computed Tomography Angiography (CCTA)/CTP procedure.~Regadenoson 0.4 mg was administered prior to each stress procedure as a single bolus injection."
817746|NCT01334918|O1|Outcome|SPECT + MDCT|Participants underwent both a rest and stress SPECT series and a rest and stress MDCT series.
817747|NCT01334918|O3|Outcome|CTP: All Fixed Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
817748|NCT01334918|O2|Outcome|CTP: ≥ 1 Fixed Defects|Participants with ≥ 1 fixed defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817750|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
817751|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817752|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817753|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
817754|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817755|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817756|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
817757|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817758|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817759|NCT01334918|O6|Outcome|MDCT: Reviewer 3|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 3.
817760|NCT01334918|O5|Outcome|MDCT: Reviewer 2|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 2.
817761|NCT01334918|O4|Outcome|MDCT: Reviewer 1|Analysis of image quality of multidetector computed tomography (MDCT) images performed by MDCT Reviewer 1.
817762|NCT01334918|O3|Outcome|SPECT: Reviewer 3|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 3.
817763|NCT01334918|O2|Outcome|SPECT: Reviewer 2|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 2.
817764|NCT01334918|O1|Outcome|SPECT: Reviewer 1|Analysis of image quality of single photon emission computed tomography (SPECT) images performed by SPECT Reviewer 1.
817765|NCT01334918|O3|Outcome|CTP: All Reversible Defects|All participants as assessed by regadenoson stress computed tomography perfusion (CTP).
817766|NCT01334918|O2|Outcome|CTP: ≥ 2 Reversible Defects|Participants with ≥ 2 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817767|NCT01334918|O1|Outcome|CTP: 0 - 1 Reversible Defects|Participants with 0 - 1 reversible defects as assessed by regadenoson stress computed tomography perfusion (CTP).
817768|NCT01334918|E2|Reported Event|MDCT|Multidetector Computed Tomography (MDCT), composed of CCTA and regadenoson CTP. Regadenoson stress CTP was performed prior to rest CCTA/CTP imaging. Regadenoson 0.4 mg was administered prior to stress CTP as a single bolus injection. The rest CCTA/CTP was performed at least 30 minutes after completion of the stress CTP, after resolution of any symptoms brought on by the regadenoson infusion and after the participant's heart rate had returned to baseline.
817769|NCT01334918|E1|Reported Event|SPECT|Resting SPECT imaging was performed prior to regadenoson stress SPECT imaging. Imaging was conducted with one of two radiotracers (99mTc sestamibi or tetrofosmin). Regadenoson 0.4 mg was administered prior to stress SPECT as a single bolus injection.
817770|NCT01334866|B1|Baseline|Study Completion Cohort|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
817771|NCT01334866|P1|Participant Flow|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
817772|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
817773|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
817774|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|91 subjects were enrolled, with 89 subjects receving the study treatment. Of the 89 subjects treated with the study procedure, 72 subjects completed the 6 month follow-up primary endpoint visit.
817775|NCT01334866|O1|Outcome|Study Procedure Cohort|89 Subjects received study treatment
817776|NCT01334866|O1|Outcome|Minimally Invasive Coronary Artery Bypass Grafting|89 Subjects received study treatment
817777|NCT01334866|E1|Reported Event|Study Procedure Cohort|89 Subjects received study treatment
817778|NCT01334723|B3|Baseline|Total|Total of all reporting groups
817779|NCT01334723|B2|Baseline|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817780|NCT01334723|B1|Baseline|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817781|NCT01334723|P2|Participant Flow|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817782|NCT01334723|P1|Participant Flow|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817783|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817784|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817785|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817786|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817787|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817788|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817789|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817790|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817791|NCT01334723|O2|Outcome|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817792|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817793|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >80%|Participants in the prostate surgery outcomes cohort with an MPR >80%
817794|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=80%|Participants in the prostate surgery outcomes cohort with an MPR <=80%
817795|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >80%|Participants in the acute urinary retention outcomes cohort with an >80%
817796|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=80%|Participants in the acute urinary retention outcomes cohort with an MPR <=80%
817797|NCT01334723|O4|Outcome|Prostate Surgery Outcomes Cohort, MPR >75%|Participants in the prostate surgery outcomes cohort with an MPR >75%
817798|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=75%|Participants in the prostate surgery outcomes cohort with an MPR <=75%
817799|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >75%|Participants in the acute urinary retention outcomes cohort with an MPR >75%
817800|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=75%|Among the Participants in the acute urinary retention outcomes cohort with an MPR <=75%
817801|NCT01334723|O4|Outcome|Prostate Surgery Outocomes Cohort, MPR >70%|Participants in the prostate surgery outcomes cohort with an MPR >70%
817802|NCT01334723|O3|Outcome|Prostate Surgery Outcomes Cohort, MPR <=70%|Participants in the prostate surgery outcomes cohort with an MPR <=70%
817803|NCT01334723|O2|Outcome|Acute Urinary Retention Outcomes Cohort, MPR >70%|Participants in the acute urinary retention outcomes cohort with an MPR >70%
817804|NCT01334723|O1|Outcome|Acute Urinary Retention Outcomes Cohort, MPR <=70%|Participants in the acute urinary retention outcomes cohort with an MPR <=70%
817805|NCT01334723|E2|Reported Event|Prostate Surgery Outcomes Cohort|This subset of the ICHIS BPH study population was used to assess surgery as a clinical outcome.
817806|NCT01334723|E1|Reported Event|Acute Urinary Retention Outcomes Cohort|This subset of the Integrated Health Care Information Solutions (ICHIS) benign prostate hyperplasia (BPH) study population was used to assess acute urinary retention as a clinical outcome.
817807|NCT01334710|B1|Baseline|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
817808|NCT01334710|P1|Participant Flow|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
817809|NCT01334710|O1|Outcome|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
817810|NCT01334710|E1|Reported Event|Sorafenib and OSI-906|"This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.~Sorafenib and OSI-906 : Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily"
817811|NCT01334606|B1|Baseline|All Study Participants|This includes all subjects randomized to either intervention sequence. Since only 3 subjects completed both study periods, the data are not presented by intervention.
817812|NCT01334606|P1|Participant Flow|All Study Participants|Since only 3 subjects completed both periods of the crossover study before it was prematurely terminated, the primary endpoint analysis could not be performed. Therefore, no tabulations by intervention were prepared.
817813|NCT01334606|O1|Outcome|All Subjects|Due to early termination of the study, only 3 subjects completed both study periods. Analysis of the primary outcome measure requires FRU data from both study periods. Due to the lack of sufficient data, no analysis was performed.
817814|NCT01334606|E3|Reported Event|8mmx31G Pen Needle|Subjects that used the 8mmx31G pen needle, either during Study Period 1 or Study Period 2
817815|NCT01334606|E2|Reported Event|4mmx32G Pen Needle|Subjects that used the 4mmx32G pen needle, either during Study Period 1 or Study Period 2
817816|NCT01334606|E1|Reported Event|All Study Participants|This includes all subjects that participated in the study. A total of 22 adverse events were reported. The investigator reported that 14 of 22 events were not related to the study product, and 8 of 22 events were unlikely related to the study product.
817817|NCT01334554|B3|Baseline|Total|Total of all reporting groups
817818|NCT01334554|B2|Baseline|Placebo|Placebo three times a day for 4 weeks
817819|NCT01334554|B1|Baseline|Sildenafil|Sildenafil 20 mg three times a day for 4 weeks
817820|NCT01334554|P2|Participant Flow|Placebo|Participants received placebo three times a day for 4 weeks
817821|NCT01334554|P1|Participant Flow|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
817822|NCT01334554|O2|Outcome|Placebo|"placebo~Placebo: No active drug"
817823|NCT01334554|O1|Outcome|Sildenafil|"Sildenafil 20 mg three times a day~Sildenafil: 20 mg three times a day."
817824|NCT01334554|O2|Outcome|Placebo|Placebo tablets, 1 tablet three times a day
817825|NCT01334554|O1|Outcome|Sildenafil|Sildenafil: 20 mg TID
817827|NCT01334554|E1|Reported Event|Sildenafil|Participants received sildenafil citrate 20 mg three times a day in a fasting condition for 4 weeks
817828|NCT01334515|B3|Baseline|Total|Total of all reporting groups
817829|NCT01334515|B2|Baseline|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817830|NCT01334515|B1|Baseline|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817831|NCT01334515|P2|Participant Flow|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817832|NCT01334515|P1|Participant Flow|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817859|NCT01334216|B2|Baseline|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
817977|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817978|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817833|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817834|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817835|NCT01334515|O2|Outcome|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817836|NCT01334515|O1|Outcome|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817876|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
817877|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
817878|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
817879|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
817837|NCT01334515|E2|Reported Event|Disease Evaluable Only by I-MIBG or BM Histology|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817838|NCT01334515|E1|Reported Event|Disease Measured by Standard Radiographic Criteria|"Treatment (hu14.18-IL2 fusion protein and isotretinoin). Patients receive sargramostim (SC [preferred]) or IV over 2 hours on days 1-2 and 8-14, hu14.18-IL2 fusion protein IV over 4 hours on days 4-6, and isotretinoin PO twice daily on days 11-24. Treatment repeats every 28 days for 4-10 courses in the absence of disease progression or unacceptable toxicity. Patients in stratum-1 who achieve SD after course 4 are removed from protocol therapy. Patients in stratum-2 who achieve SD after course 4 receive 2 additional courses of study treatment. Patients may undergo blood and bone marrow sample collection periodically for correlative studies.~hu14.18-IL2 fusion protein: Given IV~isotretinoin: Given PO~sargramostim: Given SC~laboratory biomarker analysis: Correlative studies"
817839|NCT01334229|B3|Baseline|Total|Total of all reporting groups
817840|NCT01334229|B2|Baseline|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
817841|NCT01334229|B1|Baseline|Sitagliptin First Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Pacebo for 6 weeks
817842|NCT01334229|P2|Participant Flow|Placebo First Then Sitagliptin|First intervention: Placebo for 6 weeks Washout: 4 weeks Second intervention: Sitagliptin 100 mg/d for 6 weeks
817843|NCT01334229|P1|Participant Flow|Sitagliptin Then Placebo|First intervention: Sitagliptin 100 mg/d for 6 weeks Washout: 4 weeks Second intervention: Placebo for 6 weeks
817844|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
817845|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
817846|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
817847|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
817848|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
817849|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
817850|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
817851|NCT01334229|O1|Outcome|Sitagliptin|"Sitagliptin 100 mg/d for 6 weeks~Sitagliptin: Sitagliptin 100 mg/d for 6 weeks"
817852|NCT01334229|O2|Outcome|Placebo|"Placebo for 6 weeks~Placebo: Placebo for 6 weeks"
817860|NCT01334216|B1|Baseline|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
817861|NCT01334216|P2|Participant Flow|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
817862|NCT01334216|P1|Participant Flow|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
817863|NCT01334216|O2|Outcome|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
817864|NCT01334216|O1|Outcome|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
817865|NCT01334216|E2|Reported Event|CHICA Placebo|"This arm had CHICA without the smoking cessation module~CHICA Placebo: This was CHICA without the study module."
817866|NCT01334216|E1|Reported Event|CHICA Smoking Cessation Module|"This arm had the CHICA smoking cessation module turned on~CHICA Smoking Cessation Module: The CHICA module helped to screen parents for smoking and assist them in quitting."
817867|NCT01334125|B3|Baseline|Total|Total of all reporting groups
817868|NCT01334125|B2|Baseline|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsules once daily by mouth for 9 months"
817869|NCT01334125|B1|Baseline|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
817870|NCT01334125|P2|Participant Flow|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
817871|NCT01334125|P1|Participant Flow|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
817872|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
817873|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
817874|NCT01334125|O2|Outcome|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
817875|NCT01334125|O1|Outcome|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
817993|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817880|NCT01334125|E2|Reported Event|Placebo|"1 capsule once daily by mouth for 9 months~Placebo: 1 capsule once daily by mouth for 9 months"
817881|NCT01334125|E1|Reported Event|Metformin|"Metformin 1000 mg once daily by mouth for 9 months~Metformin: Metformin 1000 mg once daily by mouth for 9 months"
817882|NCT01333956|B5|Baseline|Total|Total of all reporting groups
817883|NCT01333956|B4|Baseline|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817884|NCT01333956|B3|Baseline|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817885|NCT01333956|B2|Baseline|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817886|NCT01333956|B1|Baseline|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817887|NCT01333956|P4|Participant Flow|150mg Arm|Patients will receive 150mg of pregabalin per dose.
817888|NCT01333956|P3|Participant Flow|100mg Arm|Patients will receive 100mg of pregabalin per dose.
817889|NCT01333956|P2|Participant Flow|50mg Arm|Patients will receive 50mg of pregabalin per dose.
817890|NCT01333956|P1|Participant Flow|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose."
817891|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817892|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817893|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817894|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817895|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
818088|NCT01333397|O1|Outcome|Placebo|
817896|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817897|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817898|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817899|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817900|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817901|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817902|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817903|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817904|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817905|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817906|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817907|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817908|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817909|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817910|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817911|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817912|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817913|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817914|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817955|NCT01333722|E1|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
817915|NCT01333956|O4|Outcome|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817916|NCT01333956|O3|Outcome|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817917|NCT01333956|O2|Outcome|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817918|NCT01333956|O1|Outcome|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of post-operative day (POD)14 and one capsule at bedtime POD15, POD16."
817919|NCT01333956|E4|Reported Event|150mg Arm|"Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 150mg: Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817920|NCT01333956|E3|Reported Event|100mg Arm|"Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 100mg: Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817921|NCT01333956|E2|Reported Event|50mg Arm|"Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.~Pregabalin 50mg: Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817922|NCT01333956|E1|Reported Event|Control|"Patients will receive 0mg of pregabalin~Placebo: Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16."
817994|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817995|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817923|NCT01333865|B1|Baseline|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
817924|NCT01333865|P1|Participant Flow|Memantine (Namenda) Treatment|"Memantine: Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
817925|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
817926|NCT01333865|O1|Outcome|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
817956|NCT01333592|B3|Baseline|Total|Total of all reporting groups
817957|NCT01333592|B2|Baseline|KAD-1229 / Biguanides|
817958|NCT01333592|B1|Baseline|KAD-1229 / DPP-4 Inhibitors|
817959|NCT01333592|P2|Participant Flow|KAD-1229 / Biguanides|
817960|NCT01333592|P1|Participant Flow|KAD-1229 / DPP-4 Inhibitors|
817961|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
817962|NCT01333592|O1|Outcome|KAD-1229 / DPP-4 Inhibitors|
817963|NCT01333592|O2|Outcome|KAD-1229 / Biguanides|
817927|NCT01333865|E1|Reported Event|Memantine (Namenda) Treatment|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer’s disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.~During the 12 weeks of study duration, subjects were be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine was administered in divided dose twice a day in the morning and evening. Titration of study medication was guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects were evaluated."
817928|NCT01333813|B1|Baseline|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817929|NCT01333813|P1|Participant Flow|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817930|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817931|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817932|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817933|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817934|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817935|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817936|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817996|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818120|NCT01333397|O2|Outcome|Dysport NG 20 U|
817937|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817938|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817939|NCT01333813|O1|Outcome|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817940|NCT01333813|E1|Reported Event|Engerix-B Kinder Group|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 7-8 years of age.
817941|NCT01333722|B3|Baseline|Total|Total of all reporting groups
817942|NCT01333722|B2|Baseline|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
817943|NCT01333722|B1|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
817944|NCT01333722|P2|Participant Flow|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
817945|NCT01333722|P1|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
817946|NCT01333722|O2|Outcome|Placebo|placebo, 1 oral tablet every 12 hours
817947|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|hydrocodone/acetaminophen extended release, 1 oral tablet every 12 hours
817948|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
817949|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
817950|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
817951|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
817952|NCT01333722|O2|Outcome|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
817953|NCT01333722|O1|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of hydrocodone/acetaminophen extended release tablet, administered once every 12 hours (for a total of 4 doses).
817954|NCT01333722|E2|Reported Event|Placebo|1 dose of placebo tablet, administered once every 12 hours (for a total of 4 doses).
817979|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817980|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817981|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817982|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817983|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817984|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817985|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817986|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817987|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817988|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817989|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817990|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817991|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
817992|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
817999|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818000|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818001|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818002|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818003|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818004|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818005|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818006|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818007|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818008|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818009|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818010|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818011|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818012|NCT01333501|O2|Outcome|Interferon Beta 1b|250 μg injected s.c. every other day
818013|NCT01333501|O1|Outcome|Fingolimod|0.5 mg in capsules for oral administration once daily
818014|NCT01333501|E2|Reported Event|Interferon Beta 1b|250 μg injected s.c. every other day
818015|NCT01333501|E1|Reported Event|Fingolimod 0.5 mg|0.5 mg in capsules for oral administration once daily
818016|NCT01333488|B4|Baseline|Total|Total of all reporting groups
818017|NCT01333488|B3|Baseline|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
818018|NCT01333488|B2|Baseline|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
818019|NCT01333488|B1|Baseline|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
818020|NCT01333488|P3|Participant Flow|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
818021|NCT01333488|P2|Participant Flow|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
818022|NCT01333488|P1|Participant Flow|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
818023|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
818024|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
818025|NCT01333488|O1|Outcome|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
818026|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
818027|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
818028|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
818029|NCT01333488|O3|Outcome|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
818030|NCT01333488|O2|Outcome|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
818031|NCT01333488|O1|Outcome|Conventional Therapy|Standard of Care treatment for severe traumatic brain injury.
818089|NCT01333397|O5|Outcome|Dysport 50 U|
818090|NCT01333397|O4|Outcome|Dysport NG 75 U|
818032|NCT01333488|E3|Reported Event|Hypothermia Plus Supplemental Magnesium Sulfate Infusion|"Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.~Magnesium Sulfate: IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours."
818033|NCT01333488|E2|Reported Event|Hypothermia|"Subjects will have their core body temperatures lowered to 34C.~Arctic Sun: Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature."
818034|NCT01333488|E1|Reported Event|Conventional Therapy|Standard of care therapy for severe traumatic brain injury.
818035|NCT01333475|B3|Baseline|Total|Total of all reporting groups
818036|NCT01333475|B2|Baseline|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818121|NCT01333397|O1|Outcome|Placebo|
818122|NCT01333397|O4|Outcome|Dysport NG 75 U|
818123|NCT01333397|O3|Outcome|Dysport NG 50 U|
818037|NCT01333475|B1|Baseline|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818038|NCT01333475|P2|Participant Flow|TAC1A|"Cycle = 28 days:MK-2206:135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818039|NCT01333475|P1|Participant Flow|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818040|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818041|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818042|NCT01333475|O2|Outcome|TAC1A|"Cycle = 28 days:MK-2206: 135mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818043|NCT01333475|O1|Outcome|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818044|NCT01333475|E2|Reported Event|TAC1A|"Cycle = 28 days:MK-2206: 135 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 100 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818045|NCT01333475|E1|Reported Event|TAC1|"Cycle = 28 days:MK-2206:90 mg PO days 1, 8, 15, and 22 AZD6244 Hydrogen sulfate: 75 mg PO QD~MK-2206 + AZD6244: MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression."
818046|NCT01333436|B3|Baseline|Total|Total of all reporting groups
818047|NCT01333436|B2|Baseline|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal ( 57% fat, 31% carbohydrate, and 12% protein).
818048|NCT01333436|B1|Baseline|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein.
818049|NCT01333436|P2|Participant Flow|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818050|NCT01333436|P1|Participant Flow|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818051|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818052|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818053|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818054|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818055|NCT01333436|O2|Outcome|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818056|NCT01333436|O1|Outcome|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818057|NCT01333436|E2|Reported Event|Nondiabetic Participants|Non-diabetic participants with normal to moderately high LDL-C administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818058|NCT01333436|E1|Reported Event|Diabetic Participants|Diabetic participants with normal to moderately high low-density lipoprotein-cholesterol (LDL-C) administered a test meal by the Sponsor during Visit 2 consisting of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein).
818059|NCT01333397|B6|Baseline|Total|Total of all reporting groups
818060|NCT01333397|B5|Baseline|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818061|NCT01333397|B4|Baseline|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818062|NCT01333397|B3|Baseline|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818063|NCT01333397|B2|Baseline|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818064|NCT01333397|B1|Baseline|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818065|NCT01333397|P5|Participant Flow|Dysport 50 U|Botulinum type A toxin (Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818066|NCT01333397|P4|Participant Flow|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818067|NCT01333397|P3|Participant Flow|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818068|NCT01333397|P2|Participant Flow|Dysport NG 20 U|"Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)~Ready to Use (RU)"
818069|NCT01333397|P1|Participant Flow|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818070|NCT01333397|O2|Outcome|Dysport 50 U|
818071|NCT01333397|O1|Outcome|Placebo|
818072|NCT01333397|O4|Outcome|Dysport 50 U|
818073|NCT01333397|O3|Outcome|Dysport NG 75 U|
818074|NCT01333397|O2|Outcome|Dysport NG 50 U|
818075|NCT01333397|O1|Outcome|Dysport NG 20 U|
818076|NCT01333397|O4|Outcome|Dysport 50 U|
818077|NCT01333397|O3|Outcome|Dysport NG 75 U|
818078|NCT01333397|O2|Outcome|Dysport NG 50 U|
818079|NCT01333397|O1|Outcome|Dysport NG 20 U|
818080|NCT01333397|O4|Outcome|Dysport 50 U|
818081|NCT01333397|O3|Outcome|Dysport NG 75 U|
818082|NCT01333397|O2|Outcome|Dysport NG 50 U|
818083|NCT01333397|O1|Outcome|Dysport NG 20 U|
818084|NCT01333397|O5|Outcome|Dysport 50 U|
818085|NCT01333397|O4|Outcome|Dysport NG 75 U|
818086|NCT01333397|O3|Outcome|Dysport NG 50 U|
818087|NCT01333397|O2|Outcome|Dysport NG 20 U|
818131|NCT01333397|O4|Outcome|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818132|NCT01333397|O3|Outcome|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818133|NCT01333397|O2|Outcome|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818134|NCT01333397|O1|Outcome|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818135|NCT01333397|E5|Reported Event|Dysport 50 U|Botulinum type A toxin ((Azzalure), Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818136|NCT01333397|E4|Reported Event|Dysport NG 75 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818137|NCT01333397|E3|Reported Event|Dysport NG 50 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818138|NCT01333397|E2|Reported Event|Dysport NG 20 U|Botulinum type A toxin (Dysport RU), Intramuscular injections on Day 1 in the muscle (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818139|NCT01333397|E1|Reported Event|Placebo|Intramuscular injections on Day 1 (total injection volume of 0.25 ml divided into five intramuscular injections of 0.05 mL per injection each of which was injected into five pre-defined sites across the glabellar region) (single treatment cycle)
818140|NCT01333189|B3|Baseline|Total|Total of all reporting groups
818141|NCT01333189|B2|Baseline|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818142|NCT01333189|B1|Baseline|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818143|NCT01333189|P2|Participant Flow|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818144|NCT01333189|P1|Participant Flow|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818145|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818336|NCT01332578|E1|Reported Event|Hot Drink Remedy|Participants then received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid, which was dissolved in 150 mL of radio-labeled water.
818146|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818147|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818148|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818149|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818150|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818151|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818152|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818153|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818247|NCT01332968|P2|Participant Flow|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818337|NCT01332500|B5|Baseline|Total|Total of all reporting groups
818989|NCT01330628|B2|Baseline|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
818154|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818155|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818156|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818157|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818158|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818159|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818160|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818161|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818248|NCT01332968|P1|Participant Flow|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818386|NCT01332435|B5|Baseline|Total|Total of all reporting groups
818162|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818163|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818164|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818165|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818166|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818167|NCT01333189|O2|Outcome|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818168|NCT01333189|O1|Outcome|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818169|NCT01333189|E2|Reported Event|CONTROL: Standard of Care Exercise|"CONTROL participants were provided two weeks of home rehabilitation (6 visits) by a physical therapist. Patients then progressed to outpatient rehabilitation, consisting of 4 weeks of treatment for a total of 6 weeks of standard of care rehabilitation.~Standard of care exercise: Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of [3] days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups."
818314|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
818170|NCT01333189|E1|Reported Event|RELOAD: Weight-bearing Biofeedback Exercise|"RELOAD participants participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games. These biofeedback training sessions were provided in addition to the standard of care rehabilitation that the CONTROL group received. Total dose of exercise across groups was matched.~Weight-bearing biofeedback exercise: Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
818171|NCT01332994|B1|Baseline|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818172|NCT01332994|P1|Participant Flow|Tocilizumab (TCZ)/TCZ or TCZ/Rituximab (RTX)|All participants were assigned to receive TCZ 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using Disease Activity Score Based on 28-Joint Count (DAS28) to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of less than (<) 2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score greater than (>) 1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score less than or equal to (≤) 1.2 or a score >3.2, received RTX 1000 milligrams (mg) via IV infusion at Weeks 16 and 18.
818173|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818174|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818175|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818176|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818177|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818387|NCT01332435|B4|Baseline|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818178|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818179|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818180|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818181|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818182|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818183|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818184|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818185|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818315|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
818186|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818187|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818188|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818189|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818190|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818191|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818192|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818193|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818316|NCT01332721|E1|Reported Event|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
818194|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818195|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818196|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818197|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818198|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818199|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818200|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818201|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818317|NCT01332578|B1|Baseline|All Randomized Participants|All randomized participants who received a study treatment during the cross over study.
818318|NCT01332578|P2|Participant Flow|Standard Paracetamol Tablets First, Then Hot Drink Remedy|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water (first intervention period). After a washout period of minimum two days, one sachet of hot drink remedy with 150 mL of radio-labeled water was administered (second intervention period).
818768|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818202|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818203|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818204|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818205|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818206|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818207|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818208|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818209|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818319|NCT01332578|P1|Participant Flow|Hot Drink Remedy First, Then Standard Paracetamol Tablets|Participants received one sachet of hot drink remedy containing 1000 milligram (mg) paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid in 150 milliliter (mL) of radio-labeled water (first intervention period). After a washout period of minimum two days, a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL water were administered (second intervention period).
818320|NCT01332578|O1|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818210|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818211|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818212|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818213|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818214|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818215|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818216|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818217|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818321|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818322|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
818323|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
819375|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
818218|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818219|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818220|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818221|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818222|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818223|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818224|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818225|NCT01332994|O1|Outcome|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818324|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
818325|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818326|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
818226|NCT01332994|E1|Reported Event|TCZ/TCZ or TCZ/RTX|All participants were assigned to receive TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 infusions from Baseline to Week 12. Clinical response was assessed at Week 16 using DAS28 to determine subsequent treatment assignment. Participants who achieved early remission, defined as a DAS28 score of <2.6, were transferred to clinical routine care and no longer received study medication. Participants who were considered partial responders, defined as a decrease from Baseline in DAS28 score >1.2 or a score between 2.6 and 3.2, inclusive, received TCZ 8 mg/kg via IV infusion every 4 weeks for a total of 4 additional infusions from Week 16 to 28. Those with assessed as having no response, defined as a decrease from Baseline in DAS28 score ≤1.2 or a score >3.2, received RTX 1000 mg via IV infusion at Weeks 16 and 18.
818227|NCT01332981|B1|Baseline|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
818228|NCT01332981|P1|Participant Flow|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
818229|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
818230|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
818231|NCT01332981|O2|Outcome|Model 2|In the second one (Model 2), a stepwise selection was used on the significant parameters that were not correlated. The significance level for entry was 10% and the significance level for removal was 5%.
818232|NCT01332981|O1|Outcome|Model 1|In the first one (Model 1), a stepwise selection method was used on all parameters that were significant in the univariate analyses, whatever the significance level of the associations between parameters.
818233|NCT01332981|O1|Outcome|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
818234|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
818235|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
818236|NCT01332981|O1|Outcome|Transtuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
818237|NCT01332981|E1|Reported Event|Trastuzumab|Female participants with overexpression of human epidermal growth factor receptor 2 (HER2+) metastatic breast cancer treated with trastuzumab as first-line treatment since 2002, included in the pharmaco-epidemiological HERMINE study and were still alive at the end of the observation period in March 2005.
818238|NCT01332968|B3|Baseline|Total|Total of all reporting groups
818239|NCT01332968|B2|Baseline|Obinutuzumab+Chemotherapy - Induction Period|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818240|NCT01332968|B1|Baseline|Rituximab+Chemotherapy - Induction Period|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during induction period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818241|NCT01332968|P8|Participant Flow|Obinutuzumab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
818242|NCT01332968|P7|Participant Flow|Rituximab+Chemotherapy - Follow-Up Period|Finally, participants were followed during a 5-year follow-up period.
818243|NCT01332968|P6|Participant Flow|Obinutuzumab+Chemotherapy - Observation Period|Obinutuzumab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
818244|NCT01332968|P5|Participant Flow|Rituximab+Chemotherapy - Observation Period|Rituximab+Chemotherapy – Observation: The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Non-responders received no protocol specified treatment during the 2-year observation period.
818245|NCT01332968|P4|Participant Flow|Obinutuzumab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period.
818246|NCT01332968|P3|Participant Flow|Rituximab+Chemotherapy - Maintenance Period|The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period.
818327|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818769|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818249|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818250|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818251|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818252|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818253|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818254|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818255|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818256|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818328|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
818770|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818257|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818258|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818259|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818260|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818261|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants received either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818262|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants received either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period was followed by either a maintenance or observation period for responders or non-responders, respectively. Responders received rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders received no protocol specified treatment during the 2-year observation period. Finally, participants were followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant was chosen by the site prior to initiation of the study.
818263|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818264|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818329|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818330|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
818265|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818266|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818267|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818268|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818269|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818270|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818271|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818272|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818331|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818771|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818273|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818274|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818275|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818276|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818277|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818278|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818279|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818280|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818332|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
818772|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818281|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818282|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818283|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818284|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818285|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818286|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818287|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818288|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818333|NCT01332578|O2|Outcome|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818773|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818289|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818290|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818291|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818292|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818293|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818294|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818295|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818296|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818334|NCT01332578|O1|Outcome|Hot Drink Remedy|Participants received one sachet of hot drink remedy powder containing 1000 mg paracetamol, 10 mg phenylephrine and 40 mg ascorbic acid dissolved in 150 mL of radio-labeled water.
818774|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818297|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818298|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818299|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818300|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818301|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818302|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818303|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818304|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818335|NCT01332578|E2|Reported Event|Standard Paracetamol Tablets|Participants received a single dose of two radio-labeled tablets of standard paracetamol (500 mg each) with 150 mL of water.
818775|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818305|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818306|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818307|NCT01332968|O2|Outcome|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818308|NCT01332968|O1|Outcome|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818309|NCT01332968|E2|Reported Event|Obinutuzumab+Chemotherapy|Participants will receive either 8 cycles of obinutuzumab along with 6 cycles of CHOP (21-day cycle) or 8 cycles of obinutuzumab along with 8 cycles of CVP (21-day cycles) or 6 cycles of obinutuzumab along with 6 cycles of bendamustine (28-day cycle) during induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive obinutuzumab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818310|NCT01332968|E1|Reported Event|Rituximab+Chemotherapy|Participants will receive either 8 cycles of rituximab along with 6 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) (21-day cycle) or 8 cycles of rituximab along with 8 cycles of cyclophosphamide, vincristine, and prednisone (CVP) (21-day cycles) or 6 cycles of rituximab along with 6 cycles of bendamustine (28-day cycle) during the induction period. The induction period will be followed by either a maintenance or observation period for responders or non-responders, respectively. Responders will receive rituximab monotherapy every 2 months for 2 years during the maintenance period. Non-responders will receive no protocol specified treatment during the 2-year observation period. Finally, participants will be followed during a 5-year follow-up period. The chemotherapy regimen (CHOP or CVP or bendamustine) for individual participant will be chosen by the site prior to initiation of the study.
818311|NCT01332721|B1|Baseline|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
818312|NCT01332721|P1|Participant Flow|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
818313|NCT01332721|O1|Outcome|TRC105 and Bevacizumab|Escalating doses of TRC105 were studied in combination with standard dose bevacizumab. In accordance with the original protocol, patients in cohorts 1 and 2 received TRC105 on day 1, day 8, and day 15 and bevacizumab on day 1 of each 3 week cycle. Cohort 3 and 4 patients received TRC105 on days 8, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle), and cohort 4a and 5 patients received TRC105 on days 8, 11, 15, and 22 and bevacizumab on days 1 and 15 of cycle 1 (4 week cycle). Beyond cycle 1, patients in cohorts 3, 4, 4a, and 5 received TRC105 on days 1, 8, 15 and 22 and bevacizumab on days 1 and 15 of each 4 week cycle.
819376|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
818338|NCT01332500|B4|Baseline|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818339|NCT01332500|B3|Baseline|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818340|NCT01332500|B2|Baseline|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
818341|NCT01332500|B1|Baseline|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818342|NCT01332500|P4|Participant Flow|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818343|NCT01332500|P3|Participant Flow|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818344|NCT01332500|P2|Participant Flow|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.
818345|NCT01332500|P1|Participant Flow|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818346|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818347|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818388|NCT01332435|B3|Baseline|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818643|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818348|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818349|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818350|NCT01332500|O2|Outcome|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818351|NCT01332500|O1|Outcome|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818352|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818353|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818354|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818355|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818356|NCT01332500|O2|Outcome|Naïve - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818357|NCT01332500|O1|Outcome|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818389|NCT01332435|B2|Baseline|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818644|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818358|NCT01332500|E4|Reported Event|Switch - Oral Triptan|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) was selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to a different oral triptan in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818359|NCT01332500|E3|Reported Event|Switch - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the date of first switch to sumatriptan/naproxen sodium or an oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if they received oral triptan as their first triptan medication and then switched to sumatriptan/naproxen sodium in the enrollment period. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818360|NCT01332500|E2|Reported Event|Naïve - Oral Triptan|"Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for an oral triptan.~Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics."
818361|NCT01332500|E1|Reported Event|Naïve - Sumatriptan/Naproxen Sodium|Participants having at least one pharmacy claim for sumatriptan/naproxen sodium or an orally administered triptan during January 1, 2007 to November 30, 2009 (study period) were selected as the target population. The index date was defined as the fill date of the first chronologically occurring sumatriptan-naproxen sodium/oral triptan prescription during the enrollment period (January 1, 2009 to May 31, 2009). Participants belonged to this arm if their first prescription was for sumatriptan/naproxen sodium. Sumatriptan/naproxen sodium users were matched to oral triptan users on propensity scores based on baseline characteristics.
818362|NCT01332487|B3|Baseline|Total|Total of all reporting groups
818363|NCT01332487|B2|Baseline|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
818364|NCT01332487|B1|Baseline|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
818365|NCT01332487|P2|Participant Flow|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
818366|NCT01332487|P1|Participant Flow|Early Treatment|Participants who started 5-alpha-reductase inhibitor (5ARI) therapy within 30 days of initiating alpha-blocker (AB) treatment
818367|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
818368|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
818369|NCT01332487|O2|Outcome|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
818370|NCT01332487|O1|Outcome|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
818371|NCT01332487|E2|Reported Event|Delayed Treatment|Participants who started 5ARI therapy more than 30 days after initiating AB treatment but less than 6 months after initiating AB treatment
818372|NCT01332487|E1|Reported Event|Early Treatment|Participants who started 5ARI therapy within 30 days of initiating AB treatment
818373|NCT01332461|B3|Baseline|Total|Total of all reporting groups
818374|NCT01332461|B2|Baseline|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
818375|NCT01332461|B1|Baseline|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
818376|NCT01332461|P2|Participant Flow|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
818377|NCT01332461|P1|Participant Flow|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
818378|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
818379|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
818380|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
818381|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
818382|NCT01332461|O2|Outcome|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
818383|NCT01332461|O1|Outcome|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
818384|NCT01332461|E2|Reported Event|Other Maintenance Therapies Cohort|Tiotropium, Ipratropium, Ipratropium-albuterol combination drug product, Inhaled corticosteroid, Long-acting beta-agonist. Due to the retrospective nature of this study, dosing information is not available.
818385|NCT01332461|E1|Reported Event|Fluticasone/Salmeterol Combination (FSC) Cohort|Fluticasone/Salmeterol Combination (FSC) 250/50 micrograms (mcg) twice a day
818390|NCT01332435|B1|Baseline|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818391|NCT01332435|P4|Participant Flow|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818392|NCT01332435|P3|Participant Flow|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818393|NCT01332435|P2|Participant Flow|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818394|NCT01332435|P1|Participant Flow|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818395|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818396|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818397|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818398|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818399|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818400|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818401|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818402|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818403|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818404|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818405|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818406|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818426|NCT01332357|E1|Reported Event|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
818427|NCT01332318|B5|Baseline|Total|Total of all reporting groups
818407|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818408|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818409|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818410|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818411|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818412|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818413|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818414|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818415|NCT01332435|O4|Outcome|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818416|NCT01332435|O3|Outcome|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818417|NCT01332435|O2|Outcome|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818418|NCT01332435|O1|Outcome|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818419|NCT01332435|E4|Reported Event|PharMetrics; Late 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) &gt; 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818420|NCT01332435|E3|Reported Event|PharMetrics; Early 5ARI Initiation|Participants from PharMetrics, a database containing data from over 90 different managed healthcare plans, encompassing over 60 million lives. Early 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) within 30 days of an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818421|NCT01332435|E2|Reported Event|IHCIS; Late 5ARI Initiation|Participants from the IHCIS, a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Late 5ARI Initiation was defined as participants who started on a 5ARI (dutasteride and finasteride) > 30 days after an AB (doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin).
818422|NCT01332435|E1|Reported Event|IHCIS; Early 5ARI Initiation|Participants from the Integrated Health Care Information Solutions (IHCIS), a nationally representative managed care database that represents over 30 health plans and more than 25 million lives. Early 5ARI Initiation was defined as participants who started on a 5-alpha-reductase inhibitor (5ARI [dutasteride and finasteride]) within 30 days of an alpha-blocker (AB [doxazosin, prazosin, tamsulosin, terazosin, and alfuzosin]).
818423|NCT01332357|B1|Baseline|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
818424|NCT01332357|P1|Participant Flow|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
818425|NCT01332357|O1|Outcome|Total Population|Adult and pediatric participants with persistent asthma were identified from commercially-insured and Medicaid health plan members with both medical and pharmacy benefits who had data in one of two healthcare claims databases.
818428|NCT01332318|B4|Baseline|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818429|NCT01332318|B3|Baseline|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818430|NCT01332318|B2|Baseline|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818431|NCT01332318|B1|Baseline|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818432|NCT01332318|P4|Participant Flow|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818433|NCT01332318|P3|Participant Flow|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818434|NCT01332318|P2|Participant Flow|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818435|NCT01332318|P1|Participant Flow|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818436|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818437|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818438|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818439|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818440|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818441|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818442|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818590|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818443|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818444|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818445|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818446|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818447|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818448|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818449|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818450|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818451|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818452|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818453|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818454|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818455|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818456|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818457|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818458|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818459|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818460|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818461|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818462|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818463|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818464|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818465|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818466|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818467|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818468|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818469|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818470|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818471|NCT01332318|O1|Outcome|GEn Placebo and DPH|The GEn placebo and DPH placebo participants were pooled with the GEn placebo and DPH 50 mg on Day 16 participants. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants either took two capsules of DPH placebo or two capsules DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818472|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
819377|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
818473|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818474|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818475|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818476|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818477|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818478|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818479|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818480|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818481|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818482|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818483|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818484|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818485|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818486|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818487|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818488|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818489|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818490|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818491|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818492|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818493|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818494|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818495|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818496|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818497|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818498|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818499|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818500|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818501|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818502|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818503|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818504|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818505|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818506|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818507|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818508|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818509|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818510|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818511|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818512|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818513|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818514|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818515|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818516|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818517|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818518|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818519|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818520|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818521|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818522|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818523|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818524|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818525|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818526|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818527|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818528|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818529|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818530|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818531|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818532|NCT01332318|O4|Outcome|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818533|NCT01332318|O3|Outcome|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818534|NCT01332318|O2|Outcome|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818535|NCT01332318|O1|Outcome|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818536|NCT01332318|E4|Reported Event|GEn Placebo and DPH 50 mg on Day 16|Oral GEn placebo taken once daily and oral DPH 50 mg taken once on Day 16. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of DPH (25 mg DPH each). On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818537|NCT01332318|E3|Reported Event|GEn 1800 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: three ER tablets (600 mg GEn each). On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two ER tablets (600 mg GEn each) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818538|NCT01332318|E2|Reported Event|GEn 1200 mg and DPH Placebo|Oral GEn (XP13512/GSK1838262) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 7: two ER tablets (600 mg GEn each). Days 8 to 16: two ER tablets (600 mg GEn each) and one placebo tablet. On Day 16, participants also took two capsules of DPH placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: one ER tablet (600 mg GEn) and one placebo tablet. Days 21 to 23: one ER tablet (600 mg GEn).
818539|NCT01332318|E1|Reported Event|GEn Placebo and DPH Placebo|Oral gabapentin enacarbil (GEn) placebo taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 7: two placebo tablets. Days 8 to 16: three placebo tablets. On Day 16, participants also took two capsules of diphenhydramine (DPH) placebo. On Day 17, participants entered a 7-day Taper Period. Days 17 to 20: two placebo tablets. Days 21 to 23: one placebo tablet.
818540|NCT01332305|B6|Baseline|Total|Total of all reporting groups
818541|NCT01332305|B5|Baseline|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
818542|NCT01332305|B4|Baseline|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
818543|NCT01332305|B3|Baseline|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818544|NCT01332305|B2|Baseline|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818545|NCT01332305|B1|Baseline|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818546|NCT01332305|P5|Participant Flow|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
818547|NCT01332305|P4|Participant Flow|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
818548|NCT01332305|P3|Participant Flow|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818549|NCT01332305|P2|Participant Flow|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818550|NCT01332305|P1|Participant Flow|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818551|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
818552|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
818591|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818553|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818554|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818555|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818556|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
818557|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
818558|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818559|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818560|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818561|NCT01332305|O5|Outcome|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
818562|NCT01332305|O4|Outcome|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
818563|NCT01332305|O3|Outcome|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818564|NCT01332305|O2|Outcome|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818565|NCT01332305|O1|Outcome|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818566|NCT01332305|E5|Reported Event|GEn 2400 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: four ER tablets (2400 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three ER tablets (1800 mg GEn). Days 87 to 88: two ER tablets (1200 mg). Days 89 to 91: one ER (600 mg) tablet.
818567|NCT01332305|E4|Reported Event|GEn 1800 mg|Oral GEn 1800 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: three ER tablets (1800 mg GEn). Days 10 to 84: three ER tablets (1800 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: two ER tablets (1200 mg GEn) and one placebo tablet. Days 87 to 88: one ER tablet (600 mg) and one placebo tablet. Days 89 to 91: one placebo tablet.
818568|NCT01332305|E3|Reported Event|GEn 1200 mg|Oral GEn 1200 mg taken once daily. Days 1 to 3: one ER tablet (600 mg GEn). Days 4 to 6: two ER tablets (1200 mg GEn). Days 8 to 10: two ER tablets (1200 mg GEn) and one placebo tablet. Days 10 to 84: two ER tablets (1200 mg GEn) and two placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: one ER tablet (600 mg GEn) and two placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818569|NCT01332305|E2|Reported Event|GEn 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 6: one ER tablet (600 mg GEn) and one placebo tablet. Days 8 to 10: one ER tablet (600 mg GEn) and two placebo tablets. Days 10 to 84: one ER tablet (600 mg GEn) and three placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818570|NCT01332305|E1|Reported Event|GEn Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 6: two placebo tablets. Days 7 to 9: three placebo tablets. Days 10 to 84: four placebo tablets. On Day 85, participants entered a 7-day Taper Period. Days 85 to 86: three placebo tablets. Days 87 to 88: two placebo tablets. Days 89 to 91: one placebo tablet.
818571|NCT01332292|B1|Baseline|FF 100 µg/Placebo or Placebo/FF 100 µg|Participants received either fluticasone furoate (FF) 100 micrograms (µg) or matching placebo in the first of two 14-day treatment periods, followed by the other therapy (the therapy not received in the first treatment period) in the second 14-day treatment period. Inhaled FF 100 µg or matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818572|NCT01332292|P2|Participant Flow|Sequence 2: Placebo Followed by FF 100 µg|Participants received placebo in Treatment Period 1 and FF 100 µg in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
818573|NCT01332292|P1|Participant Flow|Sequence 1: FF 100 µg Followed by Placebo|Participants received fluticasone furoate (FF) 100 micrograms (µg) in Treatment Period 1 and matching placebo in Treatment Period 2. Inhaled FF 100 µg and matching placebo were administered once daily in the morning (Day 1 to Day 14) via a Dry Powder Inhaler. The washout period between the 14-day treatment periods was at least 7 days.
818574|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818575|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818576|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818577|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818578|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818579|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818580|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818581|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818582|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818583|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818584|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818585|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818586|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818587|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818588|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818589|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818764|NCT01332019|P2|Participant Flow|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818592|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818593|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818594|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818595|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818596|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818597|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818598|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818599|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818600|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818601|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818602|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818603|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818604|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818605|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818606|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818607|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818608|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818609|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818610|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818611|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818612|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818613|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818614|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818642|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818615|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818616|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818617|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818618|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818619|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818620|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818621|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818622|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818623|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818624|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818625|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Novel Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818626|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818627|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818628|NCT01332292|O2|Outcome|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818629|NCT01332292|O1|Outcome|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818630|NCT01332292|E2|Reported Event|FF 100 µg|All participants who received FF 100 µg in one or both of the 14-day treatment periods. Inhaled FF 100 µg was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818631|NCT01332292|E1|Reported Event|Placebo|All participants who received matching placebo in one or both of the two 14-day treatment periods. Matching placebo was administered once daily in the morning (Day 1 to Day 14) via the Dry Powder Inhaler. The washout period between the treatment periods was at least 7 days.
818632|NCT01332253|B3|Baseline|Total|Total of all reporting groups
818633|NCT01332253|B2|Baseline|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818634|NCT01332253|B1|Baseline|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818635|NCT01332253|P2|Participant Flow|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818636|NCT01332253|P1|Participant Flow|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818637|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818638|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818639|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818640|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818641|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818645|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818646|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818647|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818648|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818649|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818650|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818651|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818652|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818653|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818654|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818655|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818656|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818657|NCT01332253|O2|Outcome|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818658|NCT01332253|O1|Outcome|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818659|NCT01332253|E2|Reported Event|Normal Saline|Normal Saline: Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
818660|NCT01332253|E1|Reported Event|Intravenous Ibuprofen|Intravenous ibuprofen: Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
818661|NCT01332227|B3|Baseline|Total|Total of all reporting groups
818662|NCT01332227|B2|Baseline|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818663|NCT01332227|B1|Baseline|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818664|NCT01332227|P2|Participant Flow|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818665|NCT01332227|P1|Participant Flow|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818666|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818667|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818668|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818669|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818670|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818671|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818672|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818673|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818674|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818675|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818676|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818677|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818776|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818678|NCT01332227|O2|Outcome|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818679|NCT01332227|O1|Outcome|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818680|NCT01332227|E2|Reported Event|Atazanavir/Ritonavir + Tenofovir/Emtricitabine|Patients received atazanavir, 300-mg capsules, plus ritonavir, 100-mg tablets, and tenofovir/emtricitabine, 300/200-mg tablets, orally once daily for 48 weeks.
818681|NCT01332227|E1|Reported Event|Atazanavir/Ritonavir + Raltegravir|Patients received atazanavir, 300-mg capsules, and ritonavir, 100-mg tablets, orally once daily and raltegravir, 400-mg tablets, twice daily for 48 weeks.
818682|NCT01332149|B3|Baseline|Total|Total of all reporting groups
818683|NCT01332149|B2|Baseline|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818684|NCT01332149|B1|Baseline|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818685|NCT01332149|P2|Participant Flow|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818686|NCT01332149|P1|Participant Flow|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818687|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818688|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818689|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818690|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818691|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818692|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818693|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818694|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818695|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818696|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818697|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818698|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
819378|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
818699|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818700|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818701|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818702|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818703|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818704|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818705|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818706|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818707|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818708|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818709|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818710|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818711|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818712|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818713|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818714|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818715|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818716|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818717|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818765|NCT01332019|P1|Participant Flow|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818718|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818719|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818720|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818721|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818722|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818723|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818724|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818725|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818726|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818727|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818728|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818729|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818730|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818731|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818732|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818733|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818734|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818735|NCT01332149|O2|Outcome|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818766|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818767|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
819379|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
818736|NCT01332149|O1|Outcome|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818737|NCT01332149|E2|Reported Event|Placebo|Participants received matching placebo capsule(s) for a period of 11 weeks， which consisted of a 1-week run-in period, 9-week double-blind treatment phase and 1-week taper-off period.
818738|NCT01332149|E1|Reported Event|Pregabalin|Participants received 1 placebo capsule matched to pregabalin twice a day for 1 week (run-in period), followed by a 9-week double-blind treatment phase (1-week dose-escalation phase where participants received pregabalin 150 milligram [mg] per day in the form of 75 mg twice a day and an 8-week fixed dose phase where participants received pregabalin 300 mg per day in the form of 150 mg twice a day), and a 1-week taper-off phase where participants received pregabalin 150 mg per day (in the form of 75 mg twice a day).
818739|NCT01332123|B1|Baseline|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
818740|NCT01332123|P1|Participant Flow|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation, increased foot outward rotation, increased foot inward rotation (always 15 degrees from the neutral position)"
818741|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
818742|NCT01332123|O1|Outcome|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~All participants were subjected to the same 5 interventions (neutral alignment and 4 perturbations as detailed above) in sequence to allow repeated measures (within-subject) comparisons."
818743|NCT01332123|E1|Reported Event|Alignment Perturbations|"The following modifications were applied to the prostheses: increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)~Alignment perturbations: Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)"
818744|NCT01332071|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Avandamet 4 mg + 1000 mg in Period 1; followed by reference product: Avandamet 2 mg + 500 mg in Period 2 or reference product in Period 1 and test product in Period 2
818745|NCT01332071|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
818746|NCT01332071|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
818747|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
818748|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
818749|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
818750|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
818751|NCT01332071|O2|Outcome|Reference Product|Reference product: Metformin Hydrochloride 500 mg in both periods
818752|NCT01332071|O1|Outcome|Test Product|Test product: Metformin Hydrochloride 1000 mg in both periods
818753|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
818754|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
818755|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
818756|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
818757|NCT01332071|O2|Outcome|Reference Product|Reference product: Rosiglitazone Maleate 2 mg in both periods
818758|NCT01332071|O1|Outcome|Test Product|Test product: Rosiglitazone Maleate 4 mg in both periods
818759|NCT01332071|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: Avandamet 2 mg + 500 mg in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: Avandamet 4 mg + 1000 mg in Period 2
818760|NCT01332071|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: Rosiglitazone Maleate + Metformin film coated tablets (Avandamet) 4 milligrams (mg) + 1000 mg (GlaxoSmithKline Brasil Ltda) in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: Avandamet 2 mg + 500 mg (GlaxoSmithKline Brasil Ltda) in Period 2
818761|NCT01332019|B3|Baseline|Total|Total of all reporting groups
818762|NCT01332019|B2|Baseline|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818763|NCT01332019|B1|Baseline|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818777|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818778|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818779|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818780|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818781|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818782|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818783|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818784|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818785|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818786|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818787|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818788|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818789|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818790|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818791|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818792|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818793|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818794|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818795|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818796|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818797|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818798|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818799|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818800|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818801|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818802|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818803|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818804|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818805|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818806|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818807|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818808|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818809|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818810|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818811|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818812|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818813|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818814|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818815|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818816|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818817|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818818|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818819|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818820|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818821|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818822|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818823|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818824|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818825|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818826|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818827|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818828|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818829|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818830|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818831|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818832|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818833|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818834|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818835|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818836|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818837|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818838|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818839|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818840|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818841|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818842|NCT01332019|O2|Outcome|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818843|NCT01332019|O1|Outcome|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818844|NCT01332019|E2|Reported Event|BIIB017 Q2W|125 µg BIIB017 administered by SC injection Q2W for at least 2 years and up to 4 years.
818845|NCT01332019|E1|Reported Event|BIIB017 Q4W|125 µg BIIB017 administered by SC injection Q4W for at least 2 years and up to 4 years.
818846|NCT01331824|B1|Baseline|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
818847|NCT01331824|P1|Participant Flow|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
818848|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
818849|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
818850|NCT01331824|O1|Outcome|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
818851|NCT01331824|E1|Reported Event|Amrubicin|Patients with progressive metastatic urothelial cancer despite first-line chemotherapy. Amrubicin was initially administered at a dose of 40 mg/m2/day daily x 3 every 21-days and the dose was subsequently reduced to 35 mg/m2/day daily x 3 every 21-days.
818852|NCT01331694|B7|Baseline|Total|Total of all reporting groups
818853|NCT01331694|B6|Baseline|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818854|NCT01331694|B5|Baseline|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818855|NCT01331694|B4|Baseline|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
818856|NCT01331694|B3|Baseline|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818857|NCT01331694|B2|Baseline|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818858|NCT01331694|B1|Baseline|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
818859|NCT01331694|P6|Participant Flow|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818860|NCT01331694|P5|Participant Flow|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818861|NCT01331694|P4|Participant Flow|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
818862|NCT01331694|P3|Participant Flow|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818863|NCT01331694|P2|Participant Flow|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818895|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818864|NCT01331694|P1|Participant Flow|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 micrograms (mcg)/50 mcg
818865|NCT01331694|O3|Outcome|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818866|NCT01331694|O2|Outcome|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818867|NCT01331694|O1|Outcome|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
818868|NCT01331694|O3|Outcome|Risk Population TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818869|NCT01331694|O2|Outcome|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818870|NCT01331694|O1|Outcome|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
818871|NCT01331694|E6|Reported Event|Cost Population: TIO|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818872|NCT01331694|E5|Reported Event|Cost Population: IP|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818873|NCT01331694|E4|Reported Event|Cost Population: FSC|Participants in the Overall Cost Population (participants with 12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
818874|NCT01331694|E3|Reported Event|Risk Population: TIO|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving tiotropium bromide (TIO) 18 mcg
818875|NCT01331694|E2|Reported Event|Risk Population: IP|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving ipratropium bromide 18 mcg or ipratropium bromide/albuterol 18 mcg/103 mcg (IP)
818876|NCT01331694|E1|Reported Event|Risk Population: FSC|Participants in the Overall Risk Population (participants with 3-12 months of follow-up after initial treatment arm prescription) receiving fluticasone propionate/salmeterol combination (FSC) 250 mcg/50 mcg
818877|NCT01331681|B4|Baseline|Total|Total of all reporting groups
818878|NCT01331681|B3|Baseline|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818879|NCT01331681|B2|Baseline|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818880|NCT01331681|B1|Baseline|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818881|NCT01331681|P3|Participant Flow|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818882|NCT01331681|P2|Participant Flow|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818883|NCT01331681|P1|Participant Flow|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF [vascular endothelial growth factor] Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818884|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818885|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818886|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818887|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818888|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818889|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818890|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818891|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818892|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818893|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818894|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818896|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818897|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818898|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818899|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818900|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818901|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818902|NCT01331681|O3|Outcome|Control|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
818903|NCT01331681|O2|Outcome|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818904|NCT01331681|O1|Outcome|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818905|NCT01331681|E3|Reported Event|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks. During year 3 laser patients could receive IAI as needed (PRN) .
818906|NCT01331681|E2|Reported Event|Intravitreal Aflibercept Injection 2Q8|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
818907|NCT01331681|E1|Reported Event|Intravitreal Aflibercept Injection 2Q4|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
818908|NCT01331304|B3|Baseline|Total|Total of all reporting groups
818909|NCT01331304|B2|Baseline|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
818910|NCT01331304|B1|Baseline|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
818911|NCT01331304|P2|Participant Flow|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
818912|NCT01331304|P1|Participant Flow|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
818913|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
818914|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
818915|NCT01331304|O2|Outcome|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
818916|NCT01331304|O1|Outcome|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
818917|NCT01331304|E2|Reported Event|QTP + APT|"Study participants will take quetiapine in addition to any other medications recommended by the study physician.~Quetiapine: 100-800mg a day over 6 months"
818918|NCT01331304|E1|Reported Event|Li + APT|"Study participants will take lithium in addition to any other medications recommended by the study physician.~Lithium: 600-1200mg per day over 6 months"
818919|NCT01331291|B3|Baseline|Total|Total of all reporting groups
818920|NCT01331291|B2|Baseline|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
818921|NCT01331291|B1|Baseline|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
818922|NCT01331291|P2|Participant Flow|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
818923|NCT01331291|P1|Participant Flow|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
818924|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
818925|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
818926|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
818927|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
818928|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
818929|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
818930|NCT01331291|O2|Outcome|Arm B|"Patients that are not surgical candidates~bosutinib: Taken orally"
818931|NCT01331291|O1|Outcome|Arm A|"Patients who are surgical candidates~bosutinib: Taken orally"
818932|NCT01331291|E1|Reported Event|Combined Arms|Adverse Events were measured across all participants, regardless of arm.
818933|NCT01331213|B3|Baseline|Total|Total of all reporting groups
818934|NCT01331213|B2|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818935|NCT01331213|B1|Baseline|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818936|NCT01331213|P2|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818937|NCT01331213|P1|Participant Flow|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818938|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818988|NCT01330628|B3|Baseline|Total|Total of all reporting groups
818939|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818940|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818941|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818942|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818943|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818944|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818945|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818946|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818947|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818948|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818949|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818950|NCT01331213|O2|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818951|NCT01331213|O1|Outcome|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818952|NCT01331213|E2|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo orally.
818953|NCT01331213|E1|Reported Event|Pregabalin|Subjects randomized to this arm received a single dose of pregabalin 200mg orally.
818954|NCT01331161|B3|Baseline|Total|Total of all reporting groups
818955|NCT01331161|B2|Baseline|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
818956|NCT01331161|B1|Baseline|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
818957|NCT01331161|P2|Participant Flow|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
818958|NCT01331161|P1|Participant Flow|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
818959|NCT01331161|O2|Outcome|Age 25-40 Years|Participants between the ages of 25-40 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
818960|NCT01331161|O1|Outcome|Age 60-79 Years|Participants between the ages of 60-79 years received a single dose of the Zoster vaccine (ZOSTAVAX®) subcutaneously.
818961|NCT01331161|O2|Outcome|Participants 25-40 Years of Age|participants with one dose of vaccine
818962|NCT01331161|O1|Outcome|Participants 60-79 Years|participants who received one dose of vaccine
818963|NCT01331161|E2|Reported Event|Younger Group|"Participants between the ages of 25-40~ZOSTAVAX: shingles vaccine, one dose"
818964|NCT01331161|E1|Reported Event|Older Group|"Participants between the ages of 60-79~ZOSTAVAX: shingles vaccine, one dose"
818965|NCT01331109|B1|Baseline|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818966|NCT01331109|P1|Participant Flow|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818967|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818968|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818969|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818970|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818971|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818972|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818973|NCT01331109|O1|Outcome|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818974|NCT01331109|E1|Reported Event|Milnacipran|"oral administration, twice daily dosing~Milnacipran : maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks."
818975|NCT01331005|B3|Baseline|Total|Total of all reporting groups
818976|NCT01331005|B2|Baseline|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
818977|NCT01331005|B1|Baseline|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
818978|NCT01331005|P2|Participant Flow|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
818979|NCT01331005|P1|Participant Flow|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
818980|NCT01331005|O2|Outcome|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
818981|NCT01331005|O1|Outcome|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
818982|NCT01331005|E2|Reported Event|Nepafenac 0.1% Drops|"Nepafenac drops will be given three times per day for one year~nepafenac 0.1% drops: One drop three times per day for one year"
818983|NCT01331005|E1|Reported Event|Placebo|"Placebo will be given three times per day for one year~Nepafenac Vehicle: Placebo"
818984|NCT01330914|B1|Baseline|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
818985|NCT01330914|P1|Participant Flow|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
818986|NCT01330914|O1|Outcome|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
818987|NCT01330914|E1|Reported Event|Gastric Bypass Surgery Patients|Obese men and women undergoing gastric bypass surgery
818990|NCT01330628|B1|Baseline|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
818991|NCT01330628|P2|Participant Flow|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
818992|NCT01330628|P1|Participant Flow|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
818993|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
818994|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
818995|NCT01330628|O2|Outcome|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
818996|NCT01330628|O1|Outcome|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
818997|NCT01330628|E2|Reported Event|Balloon Angioplasty|Balloon angioplasty: standard balloon catheters for PTA
818998|NCT01330628|E1|Reported Event|Laser Atherectomy and PTA|"laser, then balloon angioplasty~Turbo Elite Laser and Turbo Tandem Laser Guide Catheters: application of laser energy to remove blockage followed by standard balloon angioplasty"
818999|NCT01330433|B3|Baseline|Total|Total of all reporting groups
819000|NCT01330433|B2|Baseline|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819001|NCT01330433|B1|Baseline|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819002|NCT01330433|P2|Participant Flow|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819003|NCT01330433|P1|Participant Flow|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819004|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819005|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819006|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819007|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819008|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819009|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819010|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819011|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819012|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819013|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819014|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819015|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819016|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819017|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819018|NCT01330433|O2|Outcome|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819019|NCT01330433|O1|Outcome|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819020|NCT01330433|E2|Reported Event|CoSeal Spray Group|"CoSeal Spray will be applied at the end of the first staged procedure in patients randomized to the experimental group.~CoSeal Surgical Spray Group: A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.~The dose regimen is as follows:~Patients weighing < 3kg will receive 1ml of CoSeal~Patients weighing 3-10kg will receive 1-2ml of CoSeal~Patients weighing >10kg will receive 2-4ml of CoSeal"
819021|NCT01330433|E1|Reported Event|No CoSeal Surgical Spray|A patient randomized to the No CoSeal Surgical Spray group will not have CoSeal Surgical Spray applied at the end of their first staged procedure.
819022|NCT01330420|B1|Baseline|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
819023|NCT01330420|P1|Participant Flow|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
819024|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
819025|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
819026|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
819027|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
819028|NCT01330420|O1|Outcome|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session mind body intervention that was derived from the Medical Symptom Reduction Program (MSRP), an earlier iteration of the BHI's current Relaxation Response Resiliency Program (3RP.)~The cornerstone of the 3RP-D is elicitation of the relaxation response, and this approach is reinforced by additional resiliency-enhancing interventions including group Cognitive Behavioral Therapy (CBT), Positive Psychology and cultivation of Conscious Positive Expectation (CPE), Social Support (SS), and promotion of Healthy Lifestyle behaviors (HL)."
819029|NCT01330420|E1|Reported Event|Relaxation Response Resiliency Program for Depression|"The Relaxation Response Resiliency Program for Depression (3RP-D) is a low-cost, easily replicable, 6-session, 1.5 hour, mind body intervention.~The 3RP-D was designed to promote resiliency by reducing the harmful effects of stress through the elicitation of the relaxation response, and through skill training to enhance positive attitudes and beliefs, nutrition, exercise, recuperative sleep, social support, and coping. Specific interventions include: cognitive behavioral therapy (CBT), enhancing social support (SS), cultivating positive attitudes and beliefs (CPE), and promoting Healthy Lifestyle Habits(HL). The 3RP-D program has been manualized for use by group facilitators and health center patients."
819030|NCT01330394|B3|Baseline|Total|Total of all reporting groups
819031|NCT01330394|B2|Baseline|Active tDCS|active transcranial Direct Current Stimulation
819032|NCT01330394|B1|Baseline|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
819033|NCT01330394|P2|Participant Flow|Active tDCS|active transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 2 mA, double 13 min stimulation with 20 min interval between them) was applied over the left (anode) and right (cathode) dorsolateral prefrontal cortex once a day for 5 consecutive days
819034|NCT01330394|P1|Participant Flow|Sham-tDCS Control|simulate control for bilateral transcranial Direct Current Stimulation on the left and right dorsolateral prefrontal cortex
819035|NCT01330394|O2|Outcome|Active tDCS|active transcranial Direct Current Stimulation
819036|NCT01330394|O1|Outcome|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
819037|NCT01330394|E2|Reported Event|Active tDCS|active transcranial Direct Current Stimulation
819038|NCT01330394|E1|Reported Event|Sham-tDCS Control|simulate control for transcranial Direct Current Stimulation
819039|NCT01330381|B3|Baseline|Total|Total of all reporting groups
819040|NCT01330381|B2|Baseline|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819041|NCT01330381|B1|Baseline|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819042|NCT01330381|P3|Participant Flow|PEG 4000 (Polyethylene Glycol)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
819043|NCT01330381|P2|Participant Flow|Placebo|"Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution.~Subjects with weight >50 kg received placebo matching prucalopride oral tablet."
819044|NCT01330381|P1|Participant Flow|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819045|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
819046|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819047|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
819048|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819049|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819050|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819051|NCT01330381|O2|Outcome|PEG 4000|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
819052|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819053|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819054|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819055|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819056|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819057|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819058|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819059|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819060|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819061|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819062|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819063|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819380|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
819064|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819065|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819066|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819067|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819068|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819069|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819070|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819071|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819072|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819073|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819074|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819075|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819076|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819077|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819078|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819079|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819080|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819081|NCT01330381|O2|Outcome|Placebo|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819082|NCT01330381|O1|Outcome|Prucalopride|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819083|NCT01330381|E4|Reported Event|PEG 4000 (Open-label Period)|Subjects received PEG 4000 oral solution at a dose of 4 gram to 20 gram once daily.
819084|NCT01330381|E3|Reported Event|Prucalopride (Open-label Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819085|NCT01330381|E2|Reported Event|Placebo (Double-blind Period)|Subjects with weight ≤50 kg received placebo matching to prucalopride oral solution. Subjects with weight >50 kg received placebo matching to prucalopride oral tablet.
819086|NCT01330381|E1|Reported Event|Prucalopride (Double-blind Period)|Subjects with weight ≤50 kg received 0.04 mg/kg prucalopride once daily as oral solution of 0.4 mg/mL. Subjects with weight >50 kg received prucalopride 2 mg oral tablet once daily.
819087|NCT01330355|B3|Baseline|Total|Total of all reporting groups
819088|NCT01330355|B2|Baseline|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
819089|NCT01330355|B1|Baseline|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
819090|NCT01330355|P2|Participant Flow|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
819091|NCT01330355|P1|Participant Flow|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
819092|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
819093|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
819094|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
819095|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
819096|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
819381|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
819097|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
819098|NCT01330355|O2|Outcome|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
819099|NCT01330355|O1|Outcome|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
819100|NCT01330355|E2|Reported Event|Gatifloxacin|"Gatifloxacin 0.3% ophthalmic solution~Gatifloxacin: Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days"
819101|NCT01330355|E1|Reported Event|Besivance|"Besifloxacin 0.6% ophthalmic suspension~Besivance: Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days"
819102|NCT01330316|B3|Baseline|Total|Total of all reporting groups
819103|NCT01330316|B2|Baseline|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819104|NCT01330316|B1|Baseline|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819105|NCT01330316|P2|Participant Flow|Non-relapse|"Faldaprevir (FDV) 240mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV for non-relapser patients.~Non-relapser are non-responder (null and partial) and breakthrough patients. Null responders are patients who did not achieve > 2 log10 decrease in HCV RNA from baseline during the treatment period.~Partial non-responders are patients who achieved > 2 log10 decrease in HCV RNA from baseline but who never achieved an undetectable level of HCV RNA.~Breakthrough are patients who achieved an undetectable HCV RNA during the treatment period but had detectable HCV RNA at the end of treatment."
819106|NCT01330316|P1|Participant Flow|Relapse|"Faldaprevir (FDV) 240 mg once daily combined with Pegylated interferon α-2a (PegIFN)/ Ribavirin (RBV) for 24 weeks was administered for relapser patients.~At week 24, patients who did not achieve early treatment success (ETS) continue with an additional 24 weeks of PegIFN/RBV.~ETS is defined as Hepatitis C virus(HCV) Ribonucleic Acid (RNA) <25 Internalional Units (IU)/millilitre (ml) (detected or undetected) at week 4 and <25 IU/ml (undetected) at week 8.~Patients who had undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) levels at the end of treatment in one of the previous studies (see recruitment details) but had detectable levels in subsequent assessments are called relapser."
819107|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819108|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819109|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819110|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819111|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819112|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819113|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819114|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819115|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819116|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819117|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819118|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819119|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819120|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819121|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819122|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819123|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819124|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819125|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819126|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819127|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819128|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819129|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819382|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
819130|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819131|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819132|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819133|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819134|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819135|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819136|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819137|NCT01330316|O2|Outcome|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819138|NCT01330316|O1|Outcome|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819139|NCT01330316|E2|Reported Event|Non-relapse|FDV 240mg once daily combined with PegIFN/RBV for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV.
819140|NCT01330316|E1|Reported Event|Relapse|FDV 240 mg once daily combined with PegIFN/RBV for 24 weeks. At week 24, if the patients did not achieve ETS the patients received an additional 24 weeks of PegIFN/RBV.
819141|NCT01330303|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2 or reference product in Period 1 and test product in Period 2
819142|NCT01330303|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
819143|NCT01330303|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
819144|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
819145|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
819146|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both period
819147|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
819148|NCT01330303|O2|Outcome|Reference Product|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in both periods
819149|NCT01330303|O1|Outcome|Test Product|Test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in both periods
819150|NCT01330303|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule in Period 2
819151|NCT01330303|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule in Period 1; followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule in Period 2
819152|NCT01330290|B1|Baseline|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819153|NCT01330290|P1|Participant Flow|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819154|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819155|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819383|NCT01329679|O2|Outcome|Placebo|
819156|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819157|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819158|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819159|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819160|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819161|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819162|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819163|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819164|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819165|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819166|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819167|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819168|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819198|NCT01330017|P3|Participant Flow|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819384|NCT01329679|O1|Outcome|5 Hour Energy|
819169|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819170|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819171|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819172|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819173|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819174|NCT01330290|O1|Outcome|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819175|NCT01330290|E1|Reported Event|Neupro® Treatment|"Routine treatment (2, 4, 6, 8, 10, 12, 14, 16 mg/24 hours) as per approved label in European Union (EU)/in accordance with the terms of the local marketing authorization for Neupro®~Neupro® : Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed."
819176|NCT01330108|B1|Baseline|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
819177|NCT01330108|P1|Participant Flow|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
819178|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
819179|NCT01330108|O1|Outcome|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
819180|NCT01330108|E1|Reported Event|Ambrisentan|"patients currently on bosentan to ambrisentan for the treatment of pulmonary arterial hypertension.~ambrisentan: ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage."
819181|NCT01330030|B3|Baseline|Total|Total of all reporting groups
819182|NCT01330030|B2|Baseline|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
819183|NCT01330030|B1|Baseline|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
819184|NCT01330030|P2|Participant Flow|Matching Placebo|matching placebo worn 24 hours for 8 weeks
819185|NCT01330030|P1|Participant Flow|Drug Selegiline|6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks
819186|NCT01330030|O2|Outcome|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
819187|NCT01330030|O1|Outcome|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
819188|NCT01330030|E2|Reported Event|Matching Placebo|"matching placebo worn 24 hours for 8 weeks~matching placebo: placebo/24hrs for 8 weeks"
819189|NCT01330030|E1|Reported Event|Drug Selegiline|"6 mg selegiline patch (transdermal) worn for 24 hours for 8 weeks~Selegiline: 6mg/24 hrs for 8 weeks"
819190|NCT01330017|B6|Baseline|Total|Total of all reporting groups
819191|NCT01330017|B5|Baseline|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
819192|NCT01330017|B4|Baseline|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819193|NCT01330017|B3|Baseline|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819194|NCT01330017|B2|Baseline|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819195|NCT01330017|B1|Baseline|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819196|NCT01330017|P5|Participant Flow|Placebo|Matching placebo was administered orally every 4 hours in combination with background loratadine treatment.
819197|NCT01330017|P4|Participant Flow|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819199|NCT01330017|P2|Participant Flow|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819200|NCT01330017|P1|Participant Flow|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819201|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819202|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819203|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819204|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819205|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819206|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819207|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819208|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819209|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819210|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819211|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819212|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819213|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819214|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819215|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819216|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819217|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819218|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819219|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819220|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819221|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819222|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819223|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819224|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819225|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819226|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819227|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819228|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819229|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819230|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819231|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819232|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819233|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819234|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819235|NCT01330017|O5|Outcome|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819236|NCT01330017|O4|Outcome|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819237|NCT01330017|O3|Outcome|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819238|NCT01330017|O2|Outcome|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819239|NCT01330017|O1|Outcome|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819240|NCT01330017|E5|Reported Event|Placebo|Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment.
819241|NCT01330017|E4|Reported Event|PE 40 mg|PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment.
819242|NCT01330017|E3|Reported Event|PE 30 mg|PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment.
819243|NCT01330017|E2|Reported Event|PE 20 mg|PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment.
819244|NCT01330017|E1|Reported Event|PE 10 mg|PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment.
819245|NCT01329978|B4|Baseline|Total|Total of all reporting groups
819246|NCT01329978|B3|Baseline|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819247|NCT01329978|B2|Baseline|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819248|NCT01329978|B1|Baseline|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819249|NCT01329978|P5|Participant Flow|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819250|NCT01329978|P4|Participant Flow|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819251|NCT01329978|P3|Participant Flow|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819252|NCT01329978|P2|Participant Flow|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819253|NCT01329978|P1|Participant Flow|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive sofosbuvir (SOF) 400 mg+pegylated interferon alfa-2a (PEG) 180 µg+ribavirin (RBV) 1000-1200 mg for 12 weeks.
819254|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819255|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819256|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819257|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819258|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819259|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819260|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819261|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819262|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819263|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819264|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819265|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819266|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819267|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819268|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819269|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819270|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819271|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819272|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819273|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819274|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819275|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819276|NCT01329978|O4|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819277|NCT01329978|O3|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819278|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819279|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819280|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819281|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819282|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819374|NCT01329679|P1|Participant Flow|Energy Drink, Then Placebo|
819283|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819284|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819285|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819286|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819287|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819288|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819289|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819290|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819291|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819292|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819293|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819294|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819295|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819296|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819297|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819298|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819299|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819300|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819301|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819302|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819303|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819304|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819305|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819306|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819307|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819308|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819309|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819310|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819311|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819312|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819313|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819314|NCT01329978|O5|Outcome|SOF+RBV Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg+RBV 1000-1200 for 12 additional weeks.
819315|NCT01329978|O4|Outcome|SOF Rerandomization Group|This group includes participants in the SOF+PEG+RBV 12 week/Rerandomization Group who were rerandomized to receive SOF 400 mg monotherapy for 12 additional weeks.
819316|NCT01329978|O3|Outcome|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819317|NCT01329978|O2|Outcome|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819318|NCT01329978|O1|Outcome|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819319|NCT01329978|E3|Reported Event|SOF+PEG+RBV 12 Week/Rerandomization Group|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks, then were rerandomized to receive SOF monotherapy or SOF+RBV for 12 additional weeks.
819320|NCT01329978|E2|Reported Event|SOF+PEG+RBV 24 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 24 weeks.
819321|NCT01329978|E1|Reported Event|SOF+PEG+RBV 12 Weeks|Participants were randomized to receive SOF 400 mg+PEG 180 µg+RBV 1000-1200 mg for 12 weeks.
819322|NCT01329939|B5|Baseline|Total|Total of all reporting groups
819323|NCT01329939|B4|Baseline|Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819324|NCT01329939|B3|Baseline|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819325|NCT01329939|B2|Baseline|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819326|NCT01329939|B1|Baseline|Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819327|NCT01329939|P4|Participant Flow|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819328|NCT01329939|P3|Participant Flow|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819329|NCT01329939|P2|Participant Flow|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819330|NCT01329939|P1|Participant Flow|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819331|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819332|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819333|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819334|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819335|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819336|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819337|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819338|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819339|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819340|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819341|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819342|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819343|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819344|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819345|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819346|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819347|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819348|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819349|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819350|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819351|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819352|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819353|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819354|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819355|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819356|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819357|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819358|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819359|NCT01329939|O4|Outcome|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819360|NCT01329939|O3|Outcome|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819361|NCT01329939|O2|Outcome|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819362|NCT01329939|O1|Outcome|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819363|NCT01329939|E4|Reported Event|Overweight/Obese Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819364|NCT01329939|E3|Reported Event|Normal Weight Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819365|NCT01329939|E2|Reported Event|Normal-weight Atopic Asthmatics, Placebo|Placebo: Age-dependent dose, nightly, 24 weeks
819366|NCT01329939|E1|Reported Event|Overweight/Obese Atopic Asthmatics, Montelukast|Montelukast: Age-dependent dose, nightly, 24 weeks
819367|NCT01329848|B1|Baseline|Discomfort Symptoms|level of discomfort symptoms while performing near work
819368|NCT01329848|P1|Participant Flow|Discomfort Symptoms|levels of discomfort while performing near work
819369|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
819370|NCT01329848|O1|Outcome|Discomfort Symptoms|level of discomfort symptoms while performing near work
819371|NCT01329848|E1|Reported Event|Changes in Visual Discomfort From Baseline|Visual discomfort while making auto-refraction recordings.
819372|NCT01329679|B1|Baseline|All Study Participants|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days Placebo: Water, lime juice and cherry flavoring
819373|NCT01329679|P2|Participant Flow|Placebo, Then Energy Drink|
819385|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
819386|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
819387|NCT01329679|O2|Outcome|Placebo|Placebo: Water, lime juice and cherry flavoring
819388|NCT01329679|O1|Outcome|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
819389|NCT01329679|E2|Reported Event|Placebo|Placebo: Water, lime juice and cherry flavoring
819390|NCT01329679|E1|Reported Event|5 Hour Energy|5 Hour Energy: 5 Hour Energy, 2oz twice daily for 7 days
819391|NCT01329562|B3|Baseline|Total|Total of all reporting groups
819392|NCT01329562|B2|Baseline|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819393|NCT01329562|B1|Baseline|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819394|NCT01329562|P2|Participant Flow|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819395|NCT01329562|P1|Participant Flow|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819396|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819397|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819398|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819399|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819400|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819401|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819402|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819446|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819506|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819403|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819404|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819405|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819406|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819407|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819408|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819409|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819410|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819411|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819412|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819413|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819414|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819415|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819416|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819447|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819417|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819418|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819419|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819420|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819421|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819422|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819423|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819424|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819425|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819426|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819427|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819428|NCT01329562|O3|Outcome|Treximet Non-Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Non-Responders were defined as subjects who had a headache with a severity of 3=Severe Pain or 2=Moderate Pain at two hours post treatment, and/or subjects that rescued with additional medication, and/or their headache increased and/or returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819503|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819429|NCT01329562|O2|Outcome|Treximet Responder|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Responders were defined as subjects who had a headache with a severity of 0=No Pain or 1=Mild Pain at two hours post treatment, and subjects could not have rescued with additional medication, and their headache could not have returned within 24 hours.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819430|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819431|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819432|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819433|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819434|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819435|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819436|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819437|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819438|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819439|NCT01329562|O2|Outcome|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819440|NCT01329562|O1|Outcome|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819441|NCT01329562|E2|Reported Event|Treximet|"Subjects randomized to Group A will be provided with 1 tablet of Treximet to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Treximet : Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg."
819442|NCT01329562|E1|Reported Event|Placebo|"Subjects randomized to Group B will be provided with 1 tablet of placebo to be taken at onset of menstrual migraine headache pain.~All subjects will be provided with 1 tablet of Treximet for treatment of persistent or recurring headache between 2 and 24 hours following treatment with study medication at headache onset.~Placebo : A placebo tablet matching Treximet for oral administration."
819443|NCT01329549|B1|Baseline|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819444|NCT01329549|P1|Participant Flow|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819445|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819655|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
819656|NCT01328769|O1|Outcome|Febuxostat|80mg daily
819448|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819449|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819450|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819451|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819452|NCT01329549|O1|Outcome|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819453|NCT01329549|E1|Reported Event|Nintedanib (150 mg) + Carboplatin + PLD|Nintedanib (150 mg) was administered orally on day 2 to Day 28 of each cycle + Carboplatin (AUC 5 mg/mL*min) intravenous infusion, day 1, once every 4 weeks + Pegylated liposomal doxorubicin (30 mg/m2) intravenous infusion, day 1, once every 4 weeks
819454|NCT01329419|B1|Baseline|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
819455|NCT01329419|P1|Participant Flow|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
819456|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
819457|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 mg of adefovir dipivoxil administered once daily
819458|NCT01329419|O1|Outcome|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
819459|NCT01329419|E1|Reported Event|Hepsera 10 mg Once a Day|Hepsera tablet containing 10 milligrams (mg) of adefovir dipivoxil administered once daily
819460|NCT01329263|B3|Baseline|Total|Total of all reporting groups
819461|NCT01329263|B2|Baseline|Control|Participants smoked their own menthol brand cigarette throughout the study.
819462|NCT01329263|B1|Baseline|Experimental|Group switched from menthol cigarette to non-menthol cigarette
819463|NCT01329263|P2|Participant Flow|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
819464|NCT01329263|P1|Participant Flow|Control|Control group: continued to smoke same, own brand cigarette.
819465|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
819466|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
819467|NCT01329263|O2|Outcome|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
819468|NCT01329263|O1|Outcome|Control|Control group: continued to smoke same, own brand cigarette.
819469|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
819470|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
819471|NCT01329263|O2|Outcome|Control|Control group smoked their own brand cigarette for entire duration of study.
819472|NCT01329263|O1|Outcome|Experimental|Experimental group switched from menthol cigarette to non-menthol cigarette
819473|NCT01329263|E2|Reported Event|Experimental|Menthol to non-menthol : Switch from smoking menthol to non-menthol cigarettes.
819474|NCT01329263|E1|Reported Event|Control|Control group: continued to smoke same, own brand cigarette.
819475|NCT01329198|B3|Baseline|Total|Total of all reporting groups
819476|NCT01329198|B2|Baseline|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819477|NCT01329198|B1|Baseline|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819478|NCT01329198|P2|Participant Flow|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819504|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819505|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819479|NCT01329198|P1|Participant Flow|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819480|NCT01329198|O5|Outcome|Subject 5|
819481|NCT01329198|O4|Outcome|Subject 4|
819482|NCT01329198|O3|Outcome|Subject 3|
819483|NCT01329198|O2|Outcome|Subject 2|
819484|NCT01329198|O1|Outcome|Subject 1|
819485|NCT01329198|O2|Outcome|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819486|NCT01329198|O1|Outcome|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819487|NCT01329198|E2|Reported Event|Active DBS|"Active stimulation through the Neuropace RNS system at settings to maximally reduce tic frequency & severity, while limiting potential stimulation-induced side-effects~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819488|NCT01329198|E1|Reported Event|Sham DBS|"Sham stimulation in which no electrical charge is delivered through the Neuropace RNS system.~NeuroPace RNS® System Deep Brain Stimulator: • There will be a one month post-operative period during which stimulation is not turned on.~One month post-implant, subjects will be randomized one to one in a blinded fashion to receive active or sham stimulation.~By Day 60, all subjects will be programmed to receive active stimulation. Physiological data will be collected for Specific Aim 2 of the study.~Both the sham and the active groups (3 subjects in each group) will undergo identical programming procedures at 30 and 60 days."
819489|NCT01329185|B3|Baseline|Total|Total of all reporting groups
819490|NCT01329185|B2|Baseline|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
819491|NCT01329185|B1|Baseline|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
819492|NCT01329185|P2|Participant Flow|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
819493|NCT01329185|P1|Participant Flow|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
819494|NCT01329185|O2|Outcome|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
819495|NCT01329185|O1|Outcome|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
819496|NCT01329185|E2|Reported Event|Valganciclovir|"Eligible consenting kidney transplant donors who are randomized to the experimental arm of the study will receive 450mg of Valganciclovir twice a day for 14 days prior to the transplant date~Valganciclovir: Valganciclovir 450mg twice a day for 14 days prior to transplant date"
819497|NCT01329185|E1|Reported Event|Placebo|"Eligible consenting kidney transplant donors who are randomized to receive placebo will be given 1 placebo in morning and 1 in evening for 14 days prior to transplant date~Placebo: 1 capsule twice a day for 14 days prior to transplant date"
819498|NCT01329029|B3|Baseline|Total|Total of all reporting groups
819499|NCT01329029|B2|Baseline|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819500|NCT01329029|B1|Baseline|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819501|NCT01329029|P2|Participant Flow|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819502|NCT01329029|P1|Participant Flow|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819657|NCT01328769|O2|Outcome|Placebo|Matching placebo dose 80mg once daily
819658|NCT01328769|O1|Outcome|Febuxostat|80mg daily
819507|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819508|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819509|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819510|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819511|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819512|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819513|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819514|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819515|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819516|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819517|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819518|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819519|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819520|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819521|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819522|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819523|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819524|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819525|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819526|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819527|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819528|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819529|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819530|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819531|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819532|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819533|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819534|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819535|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819536|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819659|NCT01328769|E2|Reported Event|Placebo|
819660|NCT01328769|E1|Reported Event|Febuxostat|
819537|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819538|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819539|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819540|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819541|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819542|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819543|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819544|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819545|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819546|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819547|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819548|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819549|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819550|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819551|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819552|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819553|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819554|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819555|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819556|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819557|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819558|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819559|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819560|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819561|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819562|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819563|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819564|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819565|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819566|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819693|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
819567|NCT01329029|O2|Outcome|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819568|NCT01329029|O1|Outcome|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819569|NCT01329029|E2|Reported Event|Placebo|Placebo-matching roflumilast tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819570|NCT01329029|E1|Reported Event|Roflumilast 500 µg|Roflumilast 500 µg tablet, orally, once daily for 52 weeks. Background therapy concomitant medication: fixed combination of long-acting β2-agonist and inhaled glucocorticosteroid.
819571|NCT01328964|B4|Baseline|Total|Total of all reporting groups
819572|NCT01328964|B3|Baseline|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
819573|NCT01328964|B2|Baseline|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
819574|NCT01328964|B1|Baseline|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
819575|NCT01328964|P3|Participant Flow|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
819576|NCT01328964|P2|Participant Flow|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
819577|NCT01328964|P1|Participant Flow|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
819578|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
819579|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
819580|NCT01328964|O2|Outcome|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
819581|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
819582|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
819583|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
819584|NCT01328964|O2|Outcome|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
819585|NCT01328964|O1|Outcome|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
819586|NCT01328964|E3|Reported Event|Montelukast|Pediatric participants aged 4-11 years that received montelukast for the treatment of asthma
819587|NCT01328964|E2|Reported Event|Budesonide|Pediatric participants aged 4-11 years that received budesonide for the treatment of asthma
819588|NCT01328964|E1|Reported Event|Fluticasone Propionate|Pediatric participants aged 4-11 years that received fluticasone propionate 44 micrograms (FP44) for the treatment of asthma
819589|NCT01328951|B3|Baseline|Total|Total of all reporting groups
819590|NCT01328951|B2|Baseline|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819591|NCT01328951|B1|Baseline|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819592|NCT01328951|P2|Participant Flow|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not epidermal growth factor receptor [EGFR] targeted therapies) or best supportive care (BSC) as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819593|NCT01328951|P1|Participant Flow|Late Erlotinib|Participants received blinded placebo tablets orally (PO) once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819594|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819595|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
820247|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
819596|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819597|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819598|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819599|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819600|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819601|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819602|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819603|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819604|NCT01328951|O2|Outcome|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819605|NCT01328951|O1|Outcome|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819606|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819607|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819608|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819609|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819610|NCT01328951|O2|Outcome|Early Erlotinib|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator during the OLP. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819611|NCT01328951|O1|Outcome|Late Erlotinib|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity. Those who demonstrated disease progression were unblinded and could receive second-line erlotinib tablets during the OLP as 150 mg PO once daily, provided by the Sponsor. This treatment continued until disease progression, death, or unacceptable toxicity. If disease progression or unacceptable toxicity occurred during the OLP, the participant entered a final SFU period. Participants could also enter the SFU period directly after the BP if they were unable to receive second-line treatment per protocol.
819612|NCT01328951|E4|Reported Event|Second-Line Chemotherapy (Early Erlotinib)|Participants who received blinded erlotinib and who demonstrated disease progression were unblinded and could receive an approved second-line therapy (but not EGFR targeted therapies) or BSC as chosen by the investigator. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
819613|NCT01328951|E3|Reported Event|Second-Line Erlotinib (Late Erlotinib)|Participants who received blinded placebo and who demonstrated disease progression were unblinded and could receive second-line erlotinib as 150-mg tablets PO once daily, provided by the Sponsor. This treatment continued during the OLP until disease progression, death, or unacceptable toxicity.
819694|NCT01328574|E1|Reported Event|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
819614|NCT01328951|E2|Reported Event|Erlotinib (Early Erlotinib)|Participants received blinded erlotinib tablets, 150 mg PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819615|NCT01328951|E1|Reported Event|Placebo (Late Erlotinib)|Participants received blinded placebo tablets PO once daily during the BP in the maintenance setting until disease progression, death, or unacceptable toxicity.
819616|NCT01328873|B1|Baseline|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
819617|NCT01328873|P1|Participant Flow|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
819618|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
819619|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
819620|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
819621|NCT01328873|O1|Outcome|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
819622|NCT01328873|O1|Outcome|Laboratory Testing|"Patients were evaluated by changes on the CT and categorized as follows:~Air space~ground glass/reticular nodular~nodular/cavitary~single patchy infiltrate~These were evaluated on CT scans and all units of measure are the same."
819623|NCT01328873|O1|Outcome|All Patients Will Receive Lab Testing on Bronchoscopy Specimen|
819624|NCT01328873|E1|Reported Event|Laboratory Testing|"All patients will receive the lab testing on bronchoscopy specimens~Microbiological analysis: Bronchoalveolar lavage (BAL) with subsequent testing for pathogens"
819625|NCT01328782|B4|Baseline|Total|Total of all reporting groups
819626|NCT01328782|B3|Baseline|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819627|NCT01328782|B2|Baseline|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819628|NCT01328782|B1|Baseline|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819629|NCT01328782|P3|Participant Flow|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819630|NCT01328782|P2|Participant Flow|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819631|NCT01328782|P1|Participant Flow|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819632|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819633|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819634|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819635|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819636|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819637|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819638|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819639|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819640|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819641|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819642|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819643|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819644|NCT01328782|O3|Outcome|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819645|NCT01328782|O2|Outcome|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819646|NCT01328782|O1|Outcome|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819647|NCT01328782|E3|Reported Event|Ropivacaine Group|This group will receive an intra-articular shot of ropivacaine during surgery and will be sent to the recovery room to receive pain medicine as needed.
819648|NCT01328782|E2|Reported Event|Bupivacaine Group|This group will receive an intra-articular shot during surgery and will then be sent to the recovery room to receive pain medication as needed.
819649|NCT01328782|E1|Reported Event|Oral Narcotic Group|This group will receive Oxycodone with Acetaminophen orally
819650|NCT01328769|B3|Baseline|Total|Total of all reporting groups
819651|NCT01328769|B2|Baseline|Placebo|Matching placebo dose 80mg once daily
819652|NCT01328769|B1|Baseline|Febuxostat|80mg daily
819653|NCT01328769|P2|Participant Flow|Placebo|Matching placebo dose 80mg once daily
819654|NCT01328769|P1|Participant Flow|Febuxostat|80mg once daily
819661|NCT01328756|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819662|NCT01328756|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 milligram (mg) capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.~At optimization period, participants started SPD489 30 mg and dose was titrated until acceptable response (30% reduction from baseline in ADHD Rating Scale-IV total score, clinical global impression-improvement [CGI-I]score of 1 or 2 with tolerable side effects) was achieved. Maximum dose was 70mg. Dose adjustments were done in dose maintenance period."
819663|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819664|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819665|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819666|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819667|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819668|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819669|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819670|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819671|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819672|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819673|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819674|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819675|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819676|NCT01328756|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (SPD489) 30, 50 and 70 mg capsules once daily orally during the 4-week dose optimization period and the 100-week maintenance period.
819677|NCT01328756|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine dimesylate (Vyvanse, SPD489) 30 to 70 mg capsule once daily orally.
819678|NCT01328717|B1|Baseline|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
819679|NCT01328717|P1|Participant Flow|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
819680|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
819681|NCT01328717|O1|Outcome|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
819682|NCT01328717|E1|Reported Event|Intended Users of the System|Subjects with diabetes and study staff used an investigational blood glucose monitoring system. As a result of one subject's low blood sugar (and thus rapidly changing glucose values) during the study, 77 subjects completed the study.
819683|NCT01328574|B1|Baseline|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
819684|NCT01328574|P1|Participant Flow|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
819685|NCT01328574|O5|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 4|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 4 (life threatening) adverse events."
819686|NCT01328574|O4|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 3|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 3 (severe) adverse events."
819687|NCT01328574|O3|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 2|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 2 (moderate) adverse events."
819688|NCT01328574|O2|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - Grade 1|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously Grade 1 (mild) adverse events."
819689|NCT01328574|O1|Outcome|TRC105 in Urothelial Carcinoma - Adverse Events - All Grades|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously~Adverse events grades 1-4 (mild, moderate, severe and life threatening)."
819690|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
819691|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
819692|NCT01328574|O1|Outcome|Single Arm-TRC105 in Urothelial Carcinoma|"TRC 105 every two weeks~TRC105: 15 mg/kg intravenously"
819696|NCT01328548|B2|Baseline|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819697|NCT01328548|B1|Baseline|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819698|NCT01328548|P2|Participant Flow|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819699|NCT01328548|P1|Participant Flow|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819700|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819701|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819702|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819703|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819704|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819705|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819706|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819707|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819708|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819709|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819710|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819711|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819712|NCT01328548|O2|Outcome|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819713|NCT01328548|O1|Outcome|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819714|NCT01328548|E2|Reported Event|Community Control Vaccine Group|Community dwelling seniors ages 60-75 years vaccinated with the Zostavax zoster vaccine
819715|NCT01328548|E1|Reported Event|Nursing Home Vaccine Group|Nursing home residents >= 80 years vaccinated with the ZOSTAVAX zoster vaccine
819716|NCT01328496|B3|Baseline|Total|Total of all reporting groups
819717|NCT01328496|B2|Baseline|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819718|NCT01328496|B1|Baseline|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819719|NCT01328496|P2|Participant Flow|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819720|NCT01328496|P1|Participant Flow|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819721|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819755|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
820248|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
819722|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819723|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819724|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819725|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819726|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819727|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819728|NCT01328496|O2|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819729|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819730|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observationalal arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819756|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819731|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819732|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819733|NCT01328496|O1|Outcome|Observational Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819734|NCT01328496|O1|Outcome|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819735|NCT01328496|E2|Reported Event|Observation Arm|"Patients requiring two UCB units will be eligible for UCBT01 on the observational arm.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819736|NCT01328496|E1|Reported Event|Research Arm|"Participant with high-risk hematologic malignancies undergoing Hematopoietic Cell Transplantation, who do not have a suitable Human Leukocyte Antigen -matched related/sibling donor, Matched Unrelated Donor or Killer immunoglobulin receptors ligand mismatched haploidentical donor identified, will receive a single UCB unit.~Intervention: Preparative Regimen~Preparative Regimen: Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
819737|NCT01328444|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
819738|NCT01328444|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819739|NCT01328444|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819740|NCT01328444|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819741|NCT01328444|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819742|NCT01328444|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
819743|NCT01328444|P1|Participant Flow|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
819744|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819745|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819746|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819747|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819748|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
819749|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
819750|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819751|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819752|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819753|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819754|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
819757|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819758|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819759|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819760|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
819761|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
819762|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819763|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819764|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819765|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819766|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
819767|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
819768|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819769|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819770|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819771|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819772|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
819773|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
819774|NCT01328444|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819775|NCT01328444|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819776|NCT01328444|O4|Outcome|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819777|NCT01328444|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819778|NCT01328444|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
819779|NCT01328444|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
819780|NCT01328444|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
819781|NCT01328444|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
819782|NCT01328444|E4|Reported Event|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
819783|NCT01328444|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
819784|NCT01328444|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
819785|NCT01328444|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
819786|NCT01328431|B3|Baseline|Total|Total of all reporting groups
819787|NCT01328431|B2|Baseline|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
819788|NCT01328431|B1|Baseline|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
819789|NCT01328431|P2|Participant Flow|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
819790|NCT01328431|P1|Participant Flow|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
819791|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
819792|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
819793|NCT01328431|O2|Outcome|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
819794|NCT01328431|O1|Outcome|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
819795|NCT01328431|E2|Reported Event|SBIRT+NRT|"Subjects receive a 6 week course of NRT, a motivational Brief Negotiated Interview, and a facilitated referral to the state's Smokers' Quitline.~Brief Intervention with NRT Initiation: Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor."
819796|NCT01328431|E1|Reported Event|Standard Care|Subjects receive a brochure for the state's Smokers' Quitline only.
819797|NCT01328405|B3|Baseline|Total|Total of all reporting groups
819798|NCT01328405|B2|Baseline|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819799|NCT01328405|B1|Baseline|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819800|NCT01328405|P2|Participant Flow|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819801|NCT01328405|P1|Participant Flow|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819802|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819803|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819804|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819805|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819806|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819807|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819808|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819809|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819810|NCT01328405|O2|Outcome|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819811|NCT01328405|O1|Outcome|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819812|NCT01328405|E2|Reported Event|Proseal LMA|LMA-Proseal TM (LMA North America, San Diego, Ca.)
819813|NCT01328405|E1|Reported Event|Air-Q LMA|Air-QⓇ intubating laryngeal mask (Mercury Medical, Clearwater, Fl.)
819814|NCT01328379|B4|Baseline|Total|Total of all reporting groups
819815|NCT01328379|B3|Baseline|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819816|NCT01328379|B2|Baseline|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819817|NCT01328379|B1|Baseline|Placebo|placebo, twice daily
819818|NCT01328379|P3|Participant Flow|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819819|NCT01328379|P2|Participant Flow|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819820|NCT01328379|P1|Participant Flow|Placebo|placebo, twice daily
819821|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819822|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819823|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
819824|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819825|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819826|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
819827|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819828|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819829|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
819830|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819831|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819832|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
819833|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819834|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819835|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
819836|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819837|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819838|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
819839|NCT01328379|O3|Outcome|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819840|NCT01328379|O2|Outcome|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819841|NCT01328379|O1|Outcome|Placebo|placebo, twice daily
819842|NCT01328379|E3|Reported Event|Dalfampridine-ER 10mg|"10mg, twice daily~Dalfampridine-ER 10mg: 10mg, twice daily"
819843|NCT01328379|E2|Reported Event|Dalfampridine-ER 5mg|"5mg, twice daily~Dalfampridine-ER 5mg: 5mg, twice daily"
819844|NCT01328379|E1|Reported Event|Placebo|placebo, twice daily
819845|NCT01328366|B1|Baseline|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819846|NCT01328366|P1|Participant Flow|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819847|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819848|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819849|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819850|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819851|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819852|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819853|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819854|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819855|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819856|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819857|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819858|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819859|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819860|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819861|NCT01328366|O1|Outcome|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819862|NCT01328366|E1|Reported Event|Participants With Severe Psoriasis|The participants had severe disease as defined by a total Psoriasis Area Severity Index (PASI) of 10 or more and a Dermatology Life Quality Index (DLQI) of more than 10 and had not responded to standard systemic therapies.
819863|NCT01328184|B1|Baseline|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
819864|NCT01328184|P1|Participant Flow|Study Overall|A open label, two-period, fixed sequence trial. Patients received one tablet of Microgynon once daily for 14 days, immediately followed by one tablet of Microgynon once daily plus 25mg empa once daily for 7 days.
819865|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819866|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819867|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819868|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819869|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819870|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819871|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819872|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819873|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819874|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
820249|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
819875|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819876|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819877|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819878|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819879|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819880|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819881|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819882|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819883|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819884|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819885|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819886|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819887|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819888|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819889|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819890|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819891|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819892|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819893|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819894|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819895|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819896|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819897|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819898|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819899|NCT01328184|O2|Outcome|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819900|NCT01328184|O1|Outcome|Microgynon|One tablet of Microgynon once daily for 14 days.
819901|NCT01328184|E2|Reported Event|Microgynon Plus Empa|One tablet of Microgynon once daily plus empa 25mg once daily for seven days
819902|NCT01328184|E1|Reported Event|Microgynon|One tablet of Microgynon once daily for 14 days.
819903|NCT01328158|B1|Baseline|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819904|NCT01328158|P1|Participant Flow|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819905|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819906|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819907|NCT01328158|O3|Outcome|Lopinavir/Ritonavir: Baseline CDC Category Unknown|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819908|NCT01328158|O2|Outcome|Lopinavir/Ritonavir: Baseline CDC Category C|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819909|NCT01328158|O1|Outcome|Lopinavir/Ritonavir: Baseline CDC Category A|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819910|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819911|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819912|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819913|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819914|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819915|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819916|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819917|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819918|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819919|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819920|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819921|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819922|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819923|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819924|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819925|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819926|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819927|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819928|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819929|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819930|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819931|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819932|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819933|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819934|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819935|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819936|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819937|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819938|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819939|NCT01328158|O1|Outcome|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819940|NCT01328158|E1|Reported Event|Lopinavir/Ritonavir|Participants with HIV infection who were receiving Lopinavir/Ritonavir or who started Lopinavir/Ritonavir therapy during the registration period were evaluated
819941|NCT01328080|B1|Baseline|Targeted UV-B|
819942|NCT01328080|P1|Participant Flow|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
819943|NCT01328080|O1|Outcome|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
819944|NCT01328080|E1|Reported Event|Targeted UVB Phototherapy|All patients were randomly assigned to receive targeted UVB phototherapy 3 times a week for 16 weeks to either the right or the left side of the scalp. The untreated side served as an internal control until the end of week 8, after which both sides of the scalp were treated.
819945|NCT01328054|B1|Baseline|Placebo and Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819946|NCT01328054|P2|Participant Flow|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 milligrams (mg) (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819947|NCT01328054|P1|Participant Flow|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
819948|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819949|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819950|NCT01328054|O1|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819994|NCT01327989|P1|Participant Flow|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
819995|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
819951|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819952|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819953|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819954|NCT01328054|O1|Outcome|Placebo/ Lapatinib|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819955|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819956|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
819957|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819958|NCT01328054|O1|Outcome|Placebo/Lapatinib 2000 mg|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2. Participants then received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819959|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819960|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
819961|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4
819962|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
819963|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819964|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
819965|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819966|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
819967|NCT01328054|O2|Outcome|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819968|NCT01328054|O1|Outcome|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
819969|NCT01328054|E2|Reported Event|Lapatinib 2000 mg|Participants received three doses of lapatinib 2000 mg (250 mg x 8 tablets/dose) in the morning and evening on Day 3 and in the morning on Day 4.
819970|NCT01328054|E1|Reported Event|Placebo|Participants received three doses of matching placebo in the morning and evening on Day 1 and in the morning on Day 2.
819971|NCT01328041|B1|Baseline|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819972|NCT01328041|P1|Participant Flow|Dolutegravir 50 mg BID|Participants received dolutegravir (DTG) 50 milligrams (mg) twice a day (BID).
819973|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819974|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819975|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819976|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819977|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819978|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819979|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819980|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819981|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819982|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819983|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819984|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819985|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819986|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819987|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819988|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819989|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819990|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819991|NCT01328041|O1|Outcome|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819992|NCT01328041|E1|Reported Event|Dolutegravir 50 mg BID|Participants received DTG 50 mg BID.
819993|NCT01327989|B1|Baseline|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
819996|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
819997|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
819998|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
819999|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
820000|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
820001|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
820002|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
820003|NCT01327989|O1|Outcome|Solitaire™ FR Device|"Eligible subjects treated with the Solitaire™ FR device.~Solitaire™ FR device"
820004|NCT01327989|E1|Reported Event|Solitaire™ FR Device|Eligible subjects treated with the Solitaire™ FR device.
820005|NCT01327976|B3|Baseline|Total|Total of all reporting groups
820006|NCT01327976|B2|Baseline|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
820007|NCT01327976|B1|Baseline|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
820008|NCT01327976|P2|Participant Flow|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
820009|NCT01327976|P1|Participant Flow|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy."
820010|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
820011|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
820012|NCT01327976|O2|Outcome|Sham (Non-active Device)|"The Sham group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBlocTherapy"
820013|NCT01327976|O1|Outcome|vBloc (Active Device)|"The vBloc group will receive a functional device that will deliver charge to the vagus nerve during the study period~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBloc Therapy"
820014|NCT01327976|O2|Outcome|Sham (Non-active Device)|The Sham group received a device that dissipated charges into an electronic circuit within the device with no lead placement. Therefore, no charge was delivered to the vagus nerve during the study period.
820015|NCT01327976|O1|Outcome|vBloc (Active Device)|The vBloc group received an active, implantable, vagal blocking medical device (Maestro® Rechargeable System) that delivered charge to the intra-abdominal anterior and posterior vagal trunks during the study period
820016|NCT01327976|E2|Reported Event|Sham (Non-active Device)|"The control group will receive a functional, but non-active device that will deliver no charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Control device will deliver no vBloc Therapy."
820017|NCT01327976|E1|Reported Event|vBloc (Active Device)|"The treatment group will receive a functional device that will deliver charge to the vagus nerve during the study period.~Active, implantable, intra abdominal vagal blocking medical device (Maestro® Rechargeable System): Active device will deliver vBlocTherapy."
820018|NCT01327885|B3|Baseline|Total|Total of all reporting groups
820019|NCT01327885|B2|Baseline|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
820020|NCT01327885|B1|Baseline|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
820021|NCT01327885|P2|Participant Flow|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
820022|NCT01327885|P1|Participant Flow|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
820023|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
820024|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
820025|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
820026|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
820027|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the PI or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
820028|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered IV as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
820029|NCT01327885|O2|Outcome|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
820030|NCT01327885|O1|Outcome|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
820031|NCT01327885|E2|Reported Event|Arm B: Dacarbazine|Dacarbazine at a dose of 850 mg/m^2, 1000 mg/m^2, or 1200 mg/m^2 (as selected by the Principal Investigator [PI] or designee prior to randomization according to the participant's clinical status) was administered as an IV infusion over 15-30 minutes (or up to 60 minutes as per institutional guidelines) on Day 1 of every 21-day treatment cycle.
820032|NCT01327885|E1|Reported Event|Arm A: Eribulin Mesylate|Eribulin mesylate at a dose of 1.4 mg/m^2 was administered intravenously (IV) as a bolus infusion over 2-5 minutes on Days 1 and 8 of every 21-day treatment cycle.
820033|NCT01327703|B1|Baseline|Entire Study Population|Includes randomized participants who received Panzytrat® 25,000 first and Kreon® 25,000 first.
820034|NCT01327703|P2|Participant Flow|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
820035|NCT01327703|P1|Participant Flow|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
820036|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
820037|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
820038|NCT01327703|O2|Outcome|Kreon® First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
820039|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
820040|NCT01327703|O2|Outcome|Kreon®, First, Then Panzytrat®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 Ph.Eur. units lipase/kg body weight/day.
820041|NCT01327703|O1|Outcome|Panzytrat® First, Then Kreon®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in first treatment period followed by Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in second treatment period. Stabilized dose for a participant was the optimal dose determined during a qualification phase that preceded the first treatment period and was based upon the participant's usual lipase and lipid intake and total dose was not to exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day.
820042|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820043|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820044|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820045|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820046|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820047|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820048|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820049|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820050|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820051|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820052|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820053|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820054|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820055|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820056|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820057|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820058|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820059|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820060|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820061|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820062|NCT01327703|O2|Outcome|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820063|NCT01327703|O1|Outcome|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820064|NCT01327703|E2|Reported Event|Kreon®|Kreon® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820065|NCT01327703|E1|Reported Event|Panzytrat®|Panzytrat® 25,000 capsule orally daily at a stabilized dose, as per investigator's discretion, for 14 days in either first treatment period or second treatment period.
820066|NCT01327677|B3|Baseline|Total|Total of all reporting groups
820067|NCT01327677|B2|Baseline|IVPCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
820068|NCT01327677|B1|Baseline|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
820069|NCT01327677|P2|Participant Flow|PCA Fentanyl|"A patient can self-administer fentanyl intravenously using a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
820070|NCT01327677|P1|Participant Flow|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
820071|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
820072|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
820073|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
820074|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
820075|NCT01327677|O2|Outcome|Intravenous Patient-controlled Analgesia (IVPCA) Fentanyl|"Fentanyl will be given with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
820076|NCT01327677|O1|Outcome|(Pro re Nata) PRN Fentanyl|"A nurse can give the patient up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
820077|NCT01327677|O2|Outcome|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
820078|NCT01327677|O1|Outcome|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
820079|NCT01327677|E2|Reported Event|PCA Fentanyl|"A patient can self-administer fentanyl intravenously with a Patient Controlled Analgesia (PCA) pump.~Fentanyl: 20mcg/demand dose with an 8 minute lock out"
820080|NCT01327677|E1|Reported Event|PRN Fentanyl|"A nurse can administer up to 3 doses of fentanyl intravenously (through a vein) each hour whenever a patient indicates that he or she is in pain.~Fentanyl: 25-50 mcg every 20 minutes"
820081|NCT01327651|B10|Baseline|Total|Total of all reporting groups
820082|NCT01327651|B9|Baseline|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820083|NCT01327651|B8|Baseline|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820084|NCT01327651|B7|Baseline|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820085|NCT01327651|B6|Baseline|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820086|NCT01327651|B5|Baseline|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820087|NCT01327651|B4|Baseline|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820088|NCT01327651|B3|Baseline|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820089|NCT01327651|B2|Baseline|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820090|NCT01327651|B1|Baseline|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820091|NCT01327651|P9|Participant Flow|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820092|NCT01327651|P8|Participant Flow|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820093|NCT01327651|P7|Participant Flow|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
820094|NCT01327651|P6|Participant Flow|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820095|NCT01327651|P5|Participant Flow|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
820096|NCT01327651|P4|Participant Flow|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
820097|NCT01327651|P3|Participant Flow|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820098|NCT01327651|P2|Participant Flow|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820099|NCT01327651|P1|Participant Flow|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
820100|NCT01327651|O12|Outcome|Harlem, United States, Seroconverted Participant #2|#2 seroconverted participants in Harlem, United States, daily arm
820101|NCT01327651|O11|Outcome|Harlem, United States, Seroconverted Participant #1|#1 seroconverted participants in Harlem, United States, not randomized
820102|NCT01327651|O10|Outcome|Bangkok, Thailand, Seroconverted Participant #2|#2 seroconverted participants in Bangkok, Thailand, not randomized
820103|NCT01327651|O9|Outcome|Bangkok, Thailand, Seroconverted Participant #1|#1 seroconverted participants in Bangkok, Thailand, not randomized
820104|NCT01327651|O8|Outcome|Cape Town, South Africa, Seroconverted Participant #8|#8 seroconverted participants in Cape Town, South Africa, event-driven arm
820105|NCT01327651|O7|Outcome|Cape Town, South Africa, Seroconverted Participant #7|#7 seroconverted participants in Cape Town, South Africa, event-driven arm
820106|NCT01327651|O6|Outcome|Cape Town, South Africa, Seroconverted Participant #6|#6 seroconverted participants in Cape Town, South Africa, time-driven arm
820107|NCT01327651|O5|Outcome|Cape Town, South Africa, Seroconverted Participant #5|#5 seroconverted participants in Cape Town, South Africa, time-driven arm
820108|NCT01327651|O4|Outcome|Cape Town, South Africa, Seroconverted Participant #4|#4 seroconverted participants in Cape Town, South Africa, daily arm
820109|NCT01327651|O3|Outcome|Cape Town, South Africa, Seroconverted Participant #3|#3 seroconverted participants in Cape Town, South Africa, not randomized
820110|NCT01327651|O2|Outcome|Cape Town, South Africa, Seroconverted Participant #2|#2 seroconverted participants in Cape Town, South Africa, not randomized
820111|NCT01327651|O1|Outcome|Cape Town, South Africa, Seroconverted Participant #1|#1 seroconverted participants in Cape Town, South Africa, not randomized
820112|NCT01327651|O12|Outcome|Harlem, United States, Seroconverted Participant #2|#2 seroconverted participants in Harlem, United States, daily arm
820113|NCT01327651|O11|Outcome|Harlem, United States, Seroconverted Participant #1|#1 seroconverted participants in Harlem, United States, not randomized
820114|NCT01327651|O10|Outcome|Bangkok, Thailand, Seroconverted Participant #2|#2 seroconverted participants in Bangkok, Thailand, not randomized
820115|NCT01327651|O9|Outcome|Bangkok, Thailand, Seroconverted Participant #1|#1 seroconverted participants in Bangkok, Thailand, not randomized
820116|NCT01327651|O8|Outcome|Cape Town, South Africa, Seroconverted Participant #8|#8 seroconverted participants in Cape Town, South Africa, event-driven arm
820117|NCT01327651|O7|Outcome|Cape Town, South Africa, Seroconverted Participant #7|#7 seroconverted participants in Cape Town, South Africa, event-driven arm
820118|NCT01327651|O6|Outcome|Cape Town, South Africa, Seroconverted Participant #6|#6 seroconverted participants in Cape Town, South Africa, time-driven arm
820119|NCT01327651|O5|Outcome|Cape Town, South Africa, Seroconverted Participant #5|#5 seroconverted participants in Cape Town, South Africa, time-driven arm
820120|NCT01327651|O4|Outcome|Cape Town, South Africa, Seroconverted Participant #4|#4 seroconverted participants in Cape Town, South Africa, daily arm
820121|NCT01327651|O3|Outcome|Cape Town, South Africa, Seroconverted Participant #3|#3 seroconverted participants in Cape Town, South Africa, not randomized
820122|NCT01327651|O2|Outcome|Cape Town, South Africa, Seroconverted Participant #2|#2 seroconverted participants in Cape Town, South Africa, not randomized
820123|NCT01327651|O1|Outcome|Cape Town, South Africa, Seroconverted Participant #1|#1 seroconverted participants in Cape Town, South Africa, not randomized
820124|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820125|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820126|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820127|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820128|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820129|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820130|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820131|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820132|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820133|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820134|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820135|NCT01327651|O7|Outcome|Daily Dosing, Harlem|Harlem participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
820136|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820137|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors"
820138|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|Bangkok participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
820139|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820140|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820141|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|Cape Town participants will receive oral FTC/TDF daily. Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors.
820142|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820143|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820144|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820145|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820146|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820147|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820148|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820149|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820150|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820151|NCT01327651|O3|Outcome|Harlem, United States|Columbia University Medical Center Institutional Review Board in New York is the IRB of record for the New York site.
820152|NCT01327651|O2|Outcome|Bangkok, Thailand|The Institutional Review Board, Human Research Protection Office, US Centers for Disease Control and Prevention and the Ethical Review Committee for Research in Human Subjects, Department of Medical Sciences, Ministry of Public Health, Thailand are the IRBs of record for the Bangkok site
820153|NCT01327651|O1|Outcome|Cape Town, South Africa|The University of Cape Town in Cape Town is the IRB of record for the Cape Town site
820154|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820155|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820156|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820157|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820158|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820159|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820160|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820161|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820162|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820163|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820164|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820165|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820166|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820167|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820168|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820169|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820170|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820171|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820172|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820173|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820174|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820175|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820176|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820177|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820178|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820179|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820180|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820181|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820182|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820183|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820184|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820185|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820186|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820187|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820188|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820189|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820190|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820191|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820192|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820193|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820194|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820195|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820196|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820197|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820198|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820199|NCT01327651|O9|Outcome|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820200|NCT01327651|O8|Outcome|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820201|NCT01327651|O7|Outcome|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820202|NCT01327651|O6|Outcome|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820203|NCT01327651|O5|Outcome|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820204|NCT01327651|O4|Outcome|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820205|NCT01327651|O3|Outcome|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820206|NCT01327651|O2|Outcome|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820207|NCT01327651|O1|Outcome|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820208|NCT01327651|E9|Reported Event|Event-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820209|NCT01327651|E8|Reported Event|Time-driven Dosing, Harlem|"Harlem participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820210|NCT01327651|E7|Reported Event|Daily Dosing, Harlem|"Harlem participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820211|NCT01327651|E6|Reported Event|Event-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820212|NCT01327651|E5|Reported Event|Time-driven Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820213|NCT01327651|E4|Reported Event|Daily Dosing, Bangkok|"Bangkok participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820214|NCT01327651|E3|Reported Event|Event-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF before and after a potential exposure to HIV infection.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820215|NCT01327651|E2|Reported Event|Time-driven Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF twice weekly with a post-exposure dose.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820216|NCT01327651|E1|Reported Event|Daily Dosing, Cape Town|"Cape Town participants will receive oral FTC/TDF daily.~Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate, two nucleoside reverse transcriptase inhibitors."
820217|NCT01327599|B1|Baseline|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820218|NCT01327599|P1|Participant Flow|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820219|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820220|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820221|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820222|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820223|NCT01327599|O1|Outcome|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820224|NCT01327599|E1|Reported Event|DUOTRAV®|Travoprost 0.004%+Timolol 0.5% ophthalmic solution, 1 drop to the study eye(s) once a day at 8:00 PM for 12 weeks
820225|NCT01327547|B3|Baseline|Total|Total of all reporting groups
820226|NCT01327547|B2|Baseline|Placebo|Participants who received placebo in combination with HAART
820227|NCT01327547|B1|Baseline|Maraviroc|Participants who received maraviroc in combination with HAART
820228|NCT01327547|P2|Participant Flow|Placebo|Participants who received placebo in combination with HAART
820229|NCT01327547|P1|Participant Flow|Maraviroc|Participants who received maraviroc in combination with HAART
820230|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820231|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820232|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820233|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820234|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820235|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820236|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820237|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820238|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820239|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820240|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820241|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820242|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820243|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820244|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820245|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820246|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820250|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820251|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820252|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820253|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820254|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820255|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820256|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820257|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820258|NCT01327547|O2|Outcome|Placebo|Participants who received placebo in combination with HAART
820259|NCT01327547|O1|Outcome|Maraviroc|Participants who received maraviroc in combination with HAART
820260|NCT01327547|E2|Reported Event|Placebo|Participants who received placebo in combination with HAART
820261|NCT01327547|E1|Reported Event|Maraviroc|Participants who received maraviroc in combination with HAART
820262|NCT01327508|B3|Baseline|Total|Total of all reporting groups
820263|NCT01327508|B2|Baseline|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
820264|NCT01327508|B1|Baseline|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
820265|NCT01327508|P2|Participant Flow|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
820266|NCT01327508|P1|Participant Flow|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
820267|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
820268|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
820269|NCT01327508|O2|Outcome|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
820270|NCT01327508|O1|Outcome|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
820271|NCT01327508|E2|Reported Event|Standard Nailing Instrumentation.|"Free-hand technique utilizes x-rays to find screw holes~Free-hand technique: Free-hand technique utilizes x-rays to find screw holes."
820272|NCT01327508|E1|Reported Event|TRIGEN SURESHOT Distal Targeting|"TRIGEN SURESHOT Distal Targeting Instrumentation is utilized to find screw holes.~TRIGEN SURESHOT Distal Targeting Instrumentation.: image-guided localization system"
820273|NCT01327482|B1|Baseline|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
820274|NCT01327482|P1|Participant Flow|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
820275|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
820276|NCT01327482|O1|Outcome|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
820277|NCT01327482|E1|Reported Event|Raltegravir|Healthy volunteers who had regular menses and were not on hormonal contraception
820278|NCT01327339|B1|Baseline|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
820279|NCT01327339|P1|Participant Flow|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 milligrams (mg), 1 mg, 2 mg of ropinirole administered once daily. All subjects will be administered of Requip in normal prescription use. Dosage regimen can be changed by the investigator according to the prescribing information.
820280|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
820281|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
820282|NCT01327339|O1|Outcome|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
820283|NCT01327339|E1|Reported Event|Requip 0.25 mg, 1 mg, 2 mg|Requip tablet containing ropinirole hydrochloride equivalent to 0.25 mg, 1 mg, 2 mg of ropinirole administered once daily
820284|NCT01327313|B5|Baseline|Total|Total of all reporting groups
820285|NCT01327313|B4|Baseline|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820286|NCT01327313|B3|Baseline|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820287|NCT01327313|B2|Baseline|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820288|NCT01327313|B1|Baseline|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820289|NCT01327313|P4|Participant Flow|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820290|NCT01327313|P3|Participant Flow|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820502|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820291|NCT01327313|P2|Participant Flow|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820292|NCT01327313|P1|Participant Flow|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820293|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820294|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820295|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820296|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820297|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820298|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820299|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820300|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820301|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820302|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820303|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820304|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820305|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820306|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820307|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820308|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820309|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820310|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820311|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820312|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820313|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820314|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820315|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820316|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820317|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820318|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820319|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820320|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820321|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820322|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820323|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820324|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820325|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820326|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820327|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820328|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820329|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820330|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820331|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820332|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820333|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820334|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820335|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820336|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820337|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820338|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820339|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820340|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820341|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820342|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820343|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820344|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820345|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820346|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820347|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820348|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820349|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820350|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820351|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820352|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820353|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820354|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820355|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820356|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820357|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820358|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820359|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820360|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820361|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820362|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820363|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820364|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820365|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820366|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820367|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820368|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820369|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820370|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820371|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820372|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820373|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820374|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820375|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820376|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820377|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820378|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820379|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820380|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820381|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820382|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820383|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820384|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820385|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820386|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820387|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820388|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820389|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820390|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820391|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820392|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820393|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820394|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820395|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820396|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820397|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820398|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820399|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820400|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820401|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820402|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820403|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820404|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820405|NCT01327313|O4|Outcome|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820406|NCT01327313|O3|Outcome|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820407|NCT01327313|O2|Outcome|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820408|NCT01327313|O1|Outcome|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820409|NCT01327313|E4|Reported Event|EMD525797 1500 mg|1500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820410|NCT01327313|E3|Reported Event|EMD525797 1000 mg|1000 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820411|NCT01327313|E2|Reported Event|EMD525797 500 mg|500 mg of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820412|NCT01327313|E1|Reported Event|EMD525797 250 mg|250 milligram (mg) of EMD525797 was administered as an intravenous infusion over 1 hour every 2 Weeks until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
820413|NCT01327300|B1|Baseline|All Study Participants|All participants were randomized to receive both mesalamine and placebo.
820414|NCT01327300|P2|Participant Flow|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
820415|NCT01327300|P1|Participant Flow|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
820416|NCT01327300|O2|Outcome|Placebo|"This group received the placebo for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.~Two patients in this cross-over study did not provide a 24 hour urine sample needed to obtain the lactulose /mannitol ratio."
820417|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks and after a 12 week treatment period, the ratio of lactulose to mannitol was measured.
820418|NCT01327300|O2|Outcome|Placebo|This group will receive the Placebo for 12 weeks. Comparison of the change in HADS score after 12 weeks of placebo is made to baseline score.
820419|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks . Comparison of the change in HADS score after 12 weeks of mesalamine is made to baseline score.
820420|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
820421|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks.~The data below show the change in IBS-QOL scores from baseline after 12 weeks of intervention."
820422|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Values reported at the baseline FBDSI score minus the 12 week FBDSI score with placebo."
820423|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Data is reported as baseline value minus 12 week mean FBDSI value with mesalamine."
820424|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation"
820425|NCT01327300|O1|Outcome|Mesalamine|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~The data below reflect the change in the increase in inflammation with regards to increased mast cells, eosinophils counts and number of activated T lymphocytes after 12 week mesalamine from baseline level of inflammation."
820426|NCT01327300|O2|Outcome|Placebo|"This group will receive the Placebo for 12 weeks.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks."
820427|NCT01327300|O1|Outcome|Mesalamine|This group received the drug Mesalamine for 12 weeks Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks
820428|NCT01327300|E2|Reported Event|Placebo Then Mesalamine|"This group will receive the Placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.~Placebo : 4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm."
820429|NCT01327300|E1|Reported Event|Mesalamine Then Placebo|"This group received the drug Mesalamine for 12 weeks then a wash out for 3 weeks prior to crossing over to the placebo arm.~Mesalamine : Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm."
820430|NCT01327053|B3|Baseline|Total|Total of all reporting groups
820431|NCT01327053|B2|Baseline|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820432|NCT01327053|B1|Baseline|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820433|NCT01327053|P2|Participant Flow|LDE225 800 mg|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820434|NCT01327053|P1|Participant Flow|LDE225 200 mg|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820435|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820436|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820437|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820438|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820439|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820440|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820441|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820442|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820443|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820444|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820445|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820446|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820447|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820448|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820449|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820450|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820451|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820452|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820453|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820454|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820455|NCT01327053|O4|Outcome|LDE225 800mg mBCC|The efficacy and safety of LDE225 800mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820456|NCT01327053|O3|Outcome|LDE225 200mg mBCC|The efficacy and safety of LDE225 200mg mBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820457|NCT01327053|O2|Outcome|LDE225 800mg laBCC|The efficacy and safety of LDE225 800mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820458|NCT01327053|O1|Outcome|LDE225 200 mg laBCC|The efficacy and safety of LDE225 200mg laBCC cohort were analyzed separately in each group. Patients who met all the inclusion and none of the exclusion criteria were treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820501|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820459|NCT01327053|E2|Reported Event|LDE225 800 mg qd|The study is double blinded and will enroll at least 100 evaluable patients in the 800 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 800 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820460|NCT01327053|E1|Reported Event|LDE225 200 mg qd|The study is double blinded and will enroll at least 50 evaluable patients in the 200 mg LDE225 arm. The efficacy and safety of LDE225 will be analyzed separately in each group. Patients who meet all the inclusion and none of the exclusion criteria will be treated with 200 mg LDE225 daily until disease progression, occurrence of intolerable toxicity, start of another anticancer treatment or withdrawal of consent.
820461|NCT01326962|B1|Baseline|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
820462|NCT01326962|P1|Participant Flow|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
820463|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820464|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820465|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820466|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820467|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820468|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820469|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820470|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820471|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820472|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820473|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820474|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820475|NCT01326962|O1|Outcome|Tocilizumab|Participants received Tocilizumab 8 mg/kg IV every 4 weeks for a total of 6 infusions up to Week 20.
820476|NCT01326962|E1|Reported Event|Tocilizumab|Participants received Tocilizumab 8 milligram per kilogram (mg/kg) intravenously (IV) every 4 weeks for a total of 6 infusions up to Week 20. A follow-up visit at Week 24 was planned, after which evaluation of responders was done. Good/moderate EULAR responders continued receiving Tocilizumab every 4 weeks, till 1 year treatment or commercial availability.
820477|NCT01326910|B3|Baseline|Total|Total of all reporting groups
820478|NCT01326910|B2|Baseline|19306-137|Marketed Topical cream applied twice daily (or as needed)
820479|NCT01326910|B1|Baseline|19306-127|Experimental Topical cream applied twice daily (or as needed)
820480|NCT01326910|P2|Participant Flow|19306-137|Marketed Topical cream applied twice daily (or as needed)
820481|NCT01326910|P1|Participant Flow|19306-127|Experimental Topical cream applied twice daily (or as needed)
820482|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
820483|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
820484|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
820485|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
820486|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
820487|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
820488|NCT01326910|O2|Outcome|19306-137|Marketed Topical cream applied twice daily (or as needed)
820489|NCT01326910|O1|Outcome|19306-127|Experimental Topical cream applied twice daily (or as needed)
820490|NCT01326910|E2|Reported Event|19306-137|Marketed Topical cream applied twice daily (or as needed)
820491|NCT01326910|E1|Reported Event|19306-127|Experimental Topical cream applied twice daily (or as needed)
820492|NCT01326845|B3|Baseline|Total|Total of all reporting groups
820493|NCT01326845|B2|Baseline|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820494|NCT01326845|B1|Baseline|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820495|NCT01326845|P2|Participant Flow|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820496|NCT01326845|P1|Participant Flow|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820497|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820498|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820499|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820500|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820503|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820504|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820505|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820506|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820507|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820508|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820509|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820510|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820511|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820512|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820513|NCT01326845|O2|Outcome|Deferasirox pm|Deferasirox 20 mg/kg/day taken in the evening, no less than 2 hours after the last food intake or at least 30 minutes before the evening meal
820514|NCT01326845|O1|Outcome|Deferasirox am|Deferasirox 20 mg/kg/day taken in the morning, 30 minutes before food
820515|NCT01326845|E2|Reported Event|ICL pm|ICL pm
820516|NCT01326845|E1|Reported Event|ICL am|ICL am
820517|NCT01326533|B3|Baseline|Total|Total of all reporting groups
820518|NCT01326533|B2|Baseline|Placebo|Placebo daily
820519|NCT01326533|B1|Baseline|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400 mg daily
820520|NCT01326533|P2|Participant Flow|Placebo|13 weeks of placebo PO
820521|NCT01326533|P1|Participant Flow|Hydroxychloroquine|13 weeks of hydroxychloroquine sulfate PO 400 mg/day
820522|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
820523|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
820524|NCT01326533|O2|Outcome|Placebo|PO daily for 13 weeks
820525|NCT01326533|O1|Outcome|Hydroxychloroquine|400 mg PO daily for 13 weeks
820526|NCT01326533|E2|Reported Event|Placebo|Placebo PO
820527|NCT01326533|E1|Reported Event|Hydroxychloroquine|Hydroxychloroquine sulfate PO 400mg/day
820528|NCT01326026|B3|Baseline|Total|Total of all reporting groups
820529|NCT01326026|B2|Baseline|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820530|NCT01326026|B1|Baseline|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820531|NCT01326026|P2|Participant Flow|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820532|NCT01326026|P1|Participant Flow|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820533|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820534|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820535|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820536|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820537|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820538|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820596|NCT01325701|B1|Baseline|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
820539|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820540|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820541|NCT01326026|O2|Outcome|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820542|NCT01326026|O1|Outcome|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820543|NCT01326026|E2|Reported Event|IDeg Step Wise|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to step wise titration algorithm: self-titration was performed once weekly based on the lowest value of three pre-breakfast SMPG values measured on three consecutive days, the two days prior to and on the day of insulin titration.
820544|NCT01326026|E1|Reported Event|IDeg Simple|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (approximately 8-40 hours intervals between doses) with pre-trial metformin according to simple titration algorithm: self-titration was performed once weekly based upon a single pre-breakfast self measured plasma glucose (SMPG) value measured on the day of insulin titration.
820545|NCT01325870|B4|Baseline|Total|Total of all reporting groups
820546|NCT01325870|B3|Baseline|S-CPR|S-CPR: standard manual CPR
820547|NCT01325870|B2|Baseline|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
820548|NCT01325870|B1|Baseline|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
820549|NCT01325870|P3|Participant Flow|S-CPR|S-CPR: standard manual CPR
820550|NCT01325870|P2|Participant Flow|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
820551|NCT01325870|P1|Participant Flow|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
820552|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
820553|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
820554|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
820555|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
820556|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
820557|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
820558|NCT01325870|O3|Outcome|S-CPR|S-CPR: standard manual CPR
820559|NCT01325870|O2|Outcome|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
820560|NCT01325870|O1|Outcome|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
820561|NCT01325870|E3|Reported Event|S-CPR|S-CPR: standard manual CPR
820562|NCT01325870|E2|Reported Event|S-CPR + ITPR|S-CPR + ITPR: standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
820563|NCT01325870|E1|Reported Event|ACD-CPR +ITD|ACD-CPR+ITD: includes combined treatment with the ResQPRO active compression decompression device and the ResQPOD ITD 16.0 impedance threshold device
820564|NCT01325792|B1|Baseline|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
820565|NCT01325792|P1|Participant Flow|Single-staged Open Complex Ventral Incisional Hernia Repair|GORE® BIO-A® Tissue Reinforcement to reinforce the midline fascial closure in single-staged open complex ventral incisional (primary or recurrent anterior abdominal wall) hernia repair.
820566|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
820567|NCT01325792|O1|Outcome|Single-staged Open Complex Ventral Incisional Hernia Repair|"primary or recurrent anterior abdominal wall hernia~GORE BIO-A Tissue Reinforcement: Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure"
820568|NCT01325792|E1|Reported Event|GORE® BIO-A® Tissue Reinforcement|Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
820569|NCT01325714|B3|Baseline|Total|Total of all reporting groups
820570|NCT01325714|B2|Baseline|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820600|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis
820571|NCT01325714|B1|Baseline|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820572|NCT01325714|P2|Participant Flow|Arm 2: Enhanced Usual Care|107 caregivers were randomized to Enhanced Usual Care. Three were excluded at baseline because of aggression and two dropped out prior to baseline (one withdrew and one deceased). 102 caregivers were included in primary analysis. Dyads assigned to EU-PC received 8 weekly 15-minute phone calls to query symptom severity, ascertain needs for immediate psychiatric care, and provide minimal support. Primary care physicians of patients assigned to both groups received American Medical Association Continuing Medical Education print material on treating pain in older adults, as well as feedback progress notes documenting the PWD’s level of pain and depression at baseline, 3 months, 6 months, and 12 months
820573|NCT01325714|P1|Participant Flow|Arm 1: PAVeD Intervention|106 caregivers were randomized to the PAVeD intervention. Five were excluded at baseline because of aggression. 101 caregivers were included in the primary analysis. Dyads assigned to PAVeD received 6 to 8 weekly sessions of 45-minute home visits. PAVeD consists of 4 weekly 45- minute “core” sessions (“Recognizing Pain”; “Recognizing and Responding to Pain and Distress”; “Enhancing Communication”; “Making Daily Activities More Pleasant and Enjoyable”) and 2 of 4 elective sessions (“Medical Treatments and Talking to Your Doctor,” “Rest and Relaxation Strategies,” “Communication Problems and Challenges,” and “Increasing Pleasant Activities”), chosen with the patient and/or caregiver through collaborative goal setting during the first session. The intervention includes didactics, skill-building, discussion, and role-playing guided by a clinician manual and caregiver workbook.
820574|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820575|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820576|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820577|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820578|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820579|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820580|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820581|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820597|NCT01325701|P2|Participant Flow|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
820598|NCT01325701|P1|Participant Flow|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
820599|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
820582|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820583|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820584|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820585|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820586|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820587|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820588|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820589|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820590|NCT01325714|O2|Outcome|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain.~N = 102"
820591|NCT01325714|O1|Outcome|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months. N = 101"
820592|NCT01325714|E2|Reported Event|Arm 2: Enhanced Usual Care|"In the comparison arm, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Enhanced Usual Care: In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
820593|NCT01325714|E1|Reported Event|Arm 1: PAVeD Intervention|"In the experimental arm, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.~PAVeD Intervention: In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months."
820594|NCT01325701|B3|Baseline|Total|Total of all reporting groups
820595|NCT01325701|B2|Baseline|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
821681|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
820601|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
820602|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
820603|NCT01325701|O2|Outcome|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
820604|NCT01325701|O1|Outcome|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
820605|NCT01325701|E2|Reported Event|PCI-32765: 840 mg|Treatment Group 2: Subjects received 840 mg of ibrutinib once daily, on a continuous basis.
820606|NCT01325701|E1|Reported Event|PCI-32765: 560 mg|Treatment Group 1: Subjects received 560 mg of ibrutinib once daily, on a continuous basis.
820607|NCT01325623|B1|Baseline|VNS Therapy (Safety Population)|The safety population consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2.
820608|NCT01325623|P1|Participant Flow|Enrolled and Treated Population (Safety Population)|"Consists of all patients who provided consent and were implanted with the AspireSR VNS Therapy System version 1 or version 2. The safety population will be used for all safety analyses. (N=31 subjects).~In version 2 of the AspireSR VNS Therapy System, the TVS diodes (present in version 1) were removed from the electrical circuit to address the accumulation of electrical charge on the sensing node (e.g. generator-can) following delivery of a stimulation."
820609|NCT01325623|O1|Outcome|Percentage Change in Heart Rate|Average percentage change in heart rate from pre-stimulation period to heart rate during VNS Therapy Stimulation, following VNS Therapy Stimulation, and following the black-out period.
820610|NCT01325623|O4|Outcome|Unstimulated Seizures|Unstimulated seizures with =>20% increase in heart rate.
820611|NCT01325623|O3|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
820612|NCT01325623|O2|Outcome|All EMU Stimulated Seizures|Stimulated Seizures with >= 20% increase in heart rate
820613|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
820614|NCT01325623|O5|Outcome|QOLIE-31-P Scores at 24 Months|QOLIE‐31‐P Scores at Follow-Up Visits
820615|NCT01325623|O4|Outcome|QOLIE-31-P Scores at 18 Months|QOLIE‐31‐P Scores at Follow-Up Visits
820616|NCT01325623|O3|Outcome|QOLIE-31-P Scores at 12 Months|QOLIE‐31‐P Scores at Follow-Up Visits
820617|NCT01325623|O2|Outcome|QOLIE-31-P Scores at 6 Months|QOLIE‐31‐P Scores at Follow-Up Visits
820618|NCT01325623|O1|Outcome|QOLIE-31-P Scores at 3 Months|QOLIE‐31‐P Scores at Follow-Up Visits
820619|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
820620|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
820621|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
820622|NCT01325623|O3|Outcome|Unstimulated Seizures|Unstimulated seizures with >20% increase in heart rate.
820623|NCT01325623|O2|Outcome|Terminated Seizures|Seizures which ended during Automatic Stimulation
820624|NCT01325623|O1|Outcome|Historical Seizures|Pre-study EEG recordings
820625|NCT01325623|O1|Outcome|Proportion of Seizures Ending During Stimulation by Type|EMU seizures that were treated with Automatic Stimulation and ended during the course of the stimulation
820626|NCT01325623|O5|Outcome|SSQ Scores at 24 Months|Change From Baseline at Each Category
820627|NCT01325623|O4|Outcome|SSQ Scores at 18 Months|Change From Baseline at Each Category
820628|NCT01325623|O3|Outcome|SSQ Scores at 12 Months|Change From Baseline at Each Category
820629|NCT01325623|O2|Outcome|SSQ Scores at 6 Months|Change From Baseline at Each Category
820630|NCT01325623|O1|Outcome|SSQ Scores at 3 Months|Change From Baseline at Each Category
820631|NCT01325623|O4|Outcome|Generalized Tonic Clonic Sz|NHS3 Scores at Follow-Up Visits
820632|NCT01325623|O3|Outcome|CPS w/2nd GTC|NHS3 Scores at Follow-Up Visits
820633|NCT01325623|O2|Outcome|Complex Partial Seizures (CPS)|NHS3 Scores at Follow-Up Visits
820634|NCT01325623|O1|Outcome|Simple Partial Seizures|NHS3 Scores at Follow-Up Visits
820635|NCT01325623|O2|Outcome|Partial Seizures|"Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (Partial Seizures)~Partial seizures consist of simple partial, complex partial, complex partial with secondarily generalized seizures."
820636|NCT01325623|O1|Outcome|Overall Seizure Responder Rate|Summary of Responders (>= 50% Seizure Counts Reduction per Month) by Visit (All seizure types)
820637|NCT01325623|O2|Outcome|Day 5 EMU or EMU Discharge|Assessment of Device Usability at EMU (Day 5 or Discharge)
820638|NCT01325623|O1|Outcome|Implant/Recovery|Assessment of Device Usability at Implant and Recovery
820639|NCT01325623|O2|Outcome|Latency Analysis of All Seizure Types|The time difference between SDA seizure detection time and the annotated seizure onset time (ALL seizures).
820640|NCT01325623|O1|Outcome|Latency Analysis of Ictal Tachycardia Seizures|"The time difference between SDA detection of the ictal tachycardia seizure and the annotated seizure onset time.~Ictal Tachycardia Seizure is defined as a seizure with an increase from a baseline heart rate to a rate that is greater than 100 bpm and is at least a 55% increase or 35 bpm."
820641|NCT01325623|O1|Outcome|Beat Detection Sensitivity By Device IPG|"Cardiac R‐Wave Detection Sensitivity Based on Device IPG and ECG Monitor Comparison for 10 second Detection Window. n denotes the total number of patients with available R‐R wave data at the visit time point."
820642|NCT01325623|O1|Outcome|Potential False Positives|Potential False Positives Based on Heart Rate Increase Associated with Seizures by Randomized SDA Setting (AutoStim Per Hour)
820643|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
820644|NCT01325623|O1|Outcome|% Sensitivity|Total number of seizures detected by M106 divided by the total number of seizures reported (investigator + confirmation by triple review) during the EMU stay
820645|NCT01325623|O3|Outcome|Total|Seizures from an ITT subject that were either identified by the investigator during EMU evaluation or during the triple review process of EEG data.
820646|NCT01325623|O2|Outcome|Reported by Triple Review|All seizures that occurred during EMU stay and that were identified by triple review post EMU.
820647|NCT01325623|O1|Outcome|Reported by Investigators|All seizures that occurred during EMU stay and that were identified by investigators.
820648|NCT01325623|E1|Reported Event|VNS Therapy - Safety Population|All adverse events were collected from baseline up to the 24-month follow-up visit for all subjects treated/implanted with the AspireSR® VNS Therapy® system. All SAEs are reported in the SAE data table, whereas only the most common AEs (> 5%) are reported in the AE data table.
820649|NCT01325532|B3|Baseline|Total|Total of all reporting groups
820650|NCT01325532|B2|Baseline|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
820651|NCT01325532|B1|Baseline|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
820652|NCT01325532|P2|Participant Flow|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
820653|NCT01325532|P1|Participant Flow|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
820654|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
820655|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
820656|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
820657|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
820658|NCT01325532|O2|Outcome|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
821682|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
820659|NCT01325532|O1|Outcome|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
820660|NCT01325532|E2|Reported Event|Sham CES|"Shame CES: The sham devices were modified to not deliver current to the headset. The current from the active device departs from the posts at the top of the device into the headsets, creating a loop when the headset is worn by the subject with the wet electrode sponges. This loop is eliminated in the sham devices by wrapping wire around the posts, thus containing the loop within the device, with no electricity leaving the headsets. This approach allows the loop to be maintained, and therefore all of the device’s green and yellow amperage lights still light up, protecting the blind.~Sham CES: Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks."
820661|NCT01325532|E1|Reported Event|Active CES|"Active CES: The FW-100 Cranial Stimulator headset was placed on the scalp over the two dorsolateral prefrontal cortex areas. The power knob was turned to maximum setting. The waveform contains a 15000Hz square wave carrier from 0-4 mAmp. The first 15Hz modulating signal provides 50msec of “on” and 16.7msec of “off” time (total 66.7msec, 50% duty cycle). A second 500Hz modulating signal changes the “on” time series of 15000Hz pulses (750 pulses/50msec) into 25 smaller bursts of 15 pulses of the 15000Hz carrier signal, for 375 pulses in 50msec. The consecutive positive burst and “off” time is followed by an opposite negative burst and “off” time, balancing the current component to zero. Output voltage ranges from 0-40V, positive and negative. CES automatically shut off after 20 mins.~Active CES: CES current"
820662|NCT01325493|B3|Baseline|Total|Total of all reporting groups
820663|NCT01325493|B2|Baseline|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820664|NCT01325493|B1|Baseline|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820665|NCT01325493|P2|Participant Flow|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820666|NCT01325493|P1|Participant Flow|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820667|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820668|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820669|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820670|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820671|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820672|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820673|NCT01325493|O2|Outcome|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820674|NCT01325493|O1|Outcome|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820675|NCT01325493|E2|Reported Event|Saline|Normal saline was administered by the anesthesiologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820676|NCT01325493|E1|Reported Event|Ketamine|Ketamine was diluted in 50mL of normal saline to a concentration of 10 mg*ml-1, administered by the anestheisologist (blind) via IV using a loading dose of 0.5 mg/kg-1, intra-operatively 0.25 mg/kg/hr-1, post-operatively 0.1 mg/kg/hr-1.
820677|NCT01325428|B1|Baseline|Part A: Afatinib Once Daily. Part B: Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
820696|NCT01325350|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820697|NCT01325350|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820698|NCT01325350|P5|Participant Flow|Minoxidil 2% Solution|Approximately one mL of minoxidil 2% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
821683|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
820678|NCT01325428|P1|Participant Flow|Afatinib (Part A). Afatinib+V (Vinorelbine) (Part B).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until Progression of their Disease (PD). In case of treatment-related adverse events (AEs), the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent."
820679|NCT01325428|O1|Outcome|Afatinib Once Daily (OD). Afatinib+V (Vinorelbine).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval."
820680|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
820681|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
820682|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
820683|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
820684|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
820685|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
820686|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
820687|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily. The 95% Confidence Interval is Exact Confidence Interval.
820688|NCT01325428|O1|Outcome|Part B: Afatinib Once Daily (OD)+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent. The 95% Confidence Interval is Exact Confidence Interval.
820689|NCT01325428|O1|Outcome|Part A: Afatinib Once Daily (OD).|"Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until PD. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.~The 95% Confidence Interval is Exact Confidence Interval."
820690|NCT01325428|E2|Reported Event|Part B: Afatinib+V (Vinorelbine).|Part B: Upon first Progression of Disease (PD), patients could enter Part B of the study, during which they continued to be treated with Afatinib and additionally were treated with Vinorelbine 25 mg/m2 per week via intravenous (i.v) infusion. Patients treated with Afatinib and Vinorelbine combination therapy could continue to receive treatment until second progression of disease, intolerable side effects, or withdrawal of consent.
820691|NCT01325428|E1|Reported Event|Part A: Afatinib Once Daily (OD).|Part A: Patients received Afatinib tablets, 40 mg taken orally Once Daily (OD) until progression of their disease. In case of treatment-related AEs, the 40 mg dose could be reduced by increments of 10 mg to 30 mg once daily or 20 mg once daily.
820692|NCT01325350|B6|Baseline|Total|Total of all reporting groups
820693|NCT01325350|B5|Baseline|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820694|NCT01325350|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820695|NCT01325350|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820699|NCT01325350|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820700|NCT01325350|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820701|NCT01325350|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820702|NCT01325350|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820703|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820704|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820705|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820706|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820707|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820708|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820709|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820710|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820711|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820712|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820713|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820714|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820715|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820716|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820717|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820718|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820719|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820720|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820721|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820722|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820723|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820724|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820725|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820726|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820727|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820728|NCT01325350|O5|Outcome|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820729|NCT01325350|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820730|NCT01325350|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820731|NCT01325350|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820732|NCT01325350|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820733|NCT01325350|E5|Reported Event|Minoxidil 2% Solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820734|NCT01325350|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820735|NCT01325350|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820736|NCT01325350|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820737|NCT01325350|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820738|NCT01325337|B6|Baseline|Total|Total of all reporting groups
820739|NCT01325337|B5|Baseline|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820740|NCT01325337|B4|Baseline|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820741|NCT01325337|B3|Baseline|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820742|NCT01325337|B2|Baseline|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820743|NCT01325337|B1|Baseline|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820744|NCT01325337|P5|Participant Flow|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820745|NCT01325337|P4|Participant Flow|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820746|NCT01325337|P3|Participant Flow|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820747|NCT01325337|P2|Participant Flow|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820748|NCT01325337|P1|Participant Flow|Bimatoprost Formulation A|Approximately one milliliter (mL) of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820749|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820750|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820751|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820752|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820753|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820754|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820755|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820756|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820757|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820758|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820759|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820760|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820761|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820762|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820763|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820764|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820765|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820766|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820767|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820768|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820769|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820770|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820771|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820772|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820773|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820774|NCT01325337|O5|Outcome|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820775|NCT01325337|O4|Outcome|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820776|NCT01325337|O3|Outcome|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820974|NCT01324349|P1|Participant Flow|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
820777|NCT01325337|O2|Outcome|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820778|NCT01325337|O1|Outcome|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820779|NCT01325337|E5|Reported Event|Minoxidil 5% Solution|Approximately one mL of minoxidil 5% solution applied evenly onto pre-specified area on scalp, twice daily for 6 months.
820780|NCT01325337|E4|Reported Event|Vehicle to Bimatoprost|Approximately one mL of vehicle to bimatoprost applied evenly onto pre-specified area on scalp, once daily for 6 months.
820781|NCT01325337|E3|Reported Event|Bimatoprost Formulation C|Approximately one mL of bimatoprost Formulation C applied evenly onto pre-specified area on scalp, once daily for 6 months.
820782|NCT01325337|E2|Reported Event|Bimatoprost Formulation B|Approximately one mL of bimatoprost Formulation B applied evenly onto pre-specified area on scalp, once daily for 6 months.
820783|NCT01325337|E1|Reported Event|Bimatoprost Formulation A|Approximately one mL of bimatoprost Formulation A applied evenly onto pre-specified area on scalp, once daily for 6 months.
820784|NCT01325311|B3|Baseline|Total|Total of all reporting groups
820785|NCT01325311|B2|Baseline|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820786|NCT01325311|B1|Baseline|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820787|NCT01325311|P2|Participant Flow|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820788|NCT01325311|P1|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820789|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820790|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820791|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820792|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820793|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820794|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820795|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820796|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820797|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820798|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820799|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820800|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820801|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820802|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820803|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820975|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
820804|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820805|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820806|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820807|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820808|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820809|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820810|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820811|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820812|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820813|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820814|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820815|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820816|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820817|NCT01325311|O2|Outcome|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820818|NCT01325311|O1|Outcome|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820819|NCT01325311|E2|Reported Event|Arm I (Cholecalciferol, Genistein)|"Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Cholecalciferol: Given PO~Genistein: Given PO~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
820820|NCT01325311|E1|Reported Event|Arm II (Placebo)|"Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies~Placebo: Given PO"
820821|NCT01324310|B1|Baseline|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Ketoconazole 400 mg oral once daily on Days 4-8"
820822|NCT01324310|P1|Participant Flow|Romidepsin and Ketoconazole|"Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8~Ketoconazole 400 mg oral once daily on Days 4-8"
820823|NCT01324310|O1|Outcome|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
820824|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820825|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820826|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820827|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820828|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820829|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820830|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820831|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820832|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820833|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820834|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820835|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820836|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820837|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820838|NCT01324310|O2|Outcome|Romidepsin and Ketoconazole Day 8|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 8; Ketoconazole 400 mg oral once daily on Days 4-8
820839|NCT01324310|O1|Outcome|Romidepsin Day 1|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1
820840|NCT01324310|E1|Reported Event|Romidepsin Plus Ketoconazole|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8. Ketoconazole 400 mg oral once daily on Days 4-8
820841|NCT01324271|B1|Baseline|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
820842|NCT01324271|P2|Participant Flow|Tympanostomy Tube Placement (Study Cohort)|Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting
820843|NCT01324271|P1|Participant Flow|Tympanostomy Tube Placement (Lead-In Procedures)|"Acclarent Tympanostomy Tube Delivery system (TTDS):~Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room."
820844|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
820845|NCT01324271|O1|Outcome|Tube Placement Using the TTDS in Office/Clinic Setting|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
820846|NCT01324271|O1|Outcome|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
820847|NCT01324271|E1|Reported Event|Tympanostomy Tube Placement|All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS).
820848|NCT01325181|B3|Baseline|Total|Total of all reporting groups
820849|NCT01325181|B2|Baseline|Ranibizumab|
820850|NCT01325181|B1|Baseline|Low-fluence PDT|
820851|NCT01325181|P2|Participant Flow|Ranibizumab|
820852|NCT01325181|P1|Participant Flow|Low-fluence PDT|
820853|NCT01325181|O2|Outcome|Ranibizumab|
820854|NCT01325181|O1|Outcome|Low-fluence PDT|
820855|NCT01325181|E2|Reported Event|Ranibizumab|
820856|NCT01325181|E1|Reported Event|Low-fluence PDT|
820857|NCT01324947|B1|Baseline|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820858|NCT01324947|P1|Participant Flow|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820859|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820860|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820861|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity"
820862|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820863|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820864|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820865|NCT01324947|O1|Outcome|Pomalidomide|"Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity~pomalidomide: Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity"
820866|NCT01324947|O1|Outcome|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820867|NCT01324947|E1|Reported Event|Pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity
820868|NCT01324882|B3|Baseline|Total|Total of all reporting groups
820869|NCT01324882|B2|Baseline|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
820870|NCT01324882|B1|Baseline|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
820871|NCT01324882|P2|Participant Flow|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
820872|NCT01324882|P1|Participant Flow|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
820873|NCT01324882|O2|Outcome|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
820874|NCT01324882|O1|Outcome|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
820875|NCT01324882|E2|Reported Event|Control|This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.
820876|NCT01324882|E1|Reported Event|Study Arm|This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.
820877|NCT01324687|B3|Baseline|Total|Total of all reporting groups
820878|NCT01324687|B2|Baseline|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
820879|NCT01324687|B1|Baseline|Control|Group without access to telemedicine in the home for acute care issues.
821684|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
820880|NCT01324687|P2|Participant Flow|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
820881|NCT01324687|P1|Participant Flow|Control|Group without access to telemedicine in the home for acute care issues.
820882|NCT01324687|O2|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
820883|NCT01324687|O1|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
820884|NCT01324687|O2|Outcome|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
820885|NCT01324687|O1|Outcome|Control|Group without access to telemedicine in the home for acute care issues.
820886|NCT01324687|E2|Reported Event|Telemedicine Care|"Cohort with access to telemedicine in the home for acute care issues.~Telemedicine care: Availability of telemedicine"
820887|NCT01324687|E1|Reported Event|Control|Group without access to telemedicine in the home for acute care issues.
820888|NCT01324622|B3|Baseline|Total|Total of all reporting groups
820889|NCT01324622|B2|Baseline|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820890|NCT01324622|B1|Baseline|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820891|NCT01324622|P2|Participant Flow|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820892|NCT01324622|P1|Participant Flow|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820893|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820894|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820895|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820896|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820897|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820898|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820899|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820900|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820901|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820902|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820903|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820904|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820905|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820906|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820907|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820908|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820909|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820910|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820911|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820912|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820913|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820914|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820915|NCT01324622|O2|Outcome|Laminoplasty|Treatment group: Laminoplasty using ARCH Fixation System with allograft bone spacers
820916|NCT01324622|O1|Outcome|Laminectomy|Active Comparator: Laminectomy Control, Standard Procedure
820917|NCT01324622|E2|Reported Event|Laminoplasty|"Treatment group~Laminoplasty: Utilizing the ARCH Fixation System (Study device)"
820918|NCT01324622|E1|Reported Event|Laminectomy|"Control~laminectomy: standard procedure"
820919|NCT01324440|B3|Baseline|Total|Total of all reporting groups
820920|NCT01324440|B2|Baseline|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
820921|NCT01324440|B1|Baseline|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
820922|NCT01324440|P2|Participant Flow|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
820923|NCT01324440|P1|Participant Flow|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
820924|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
820925|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
820926|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
820927|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
820928|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
820929|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
820930|NCT01324440|O2|Outcome|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
820931|NCT01324440|O1|Outcome|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
820932|NCT01324440|E2|Reported Event|V710 Without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly.
820933|NCT01324440|E1|Reported Event|V710 With MAA|Single 0.5-mL injection (30-µg) dose of V710 with MAA, intramuscularly.
820934|NCT01324401|B3|Baseline|Total|Total of all reporting groups
820935|NCT01324401|B2|Baseline|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
820936|NCT01324401|B1|Baseline|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will have the opportunity to cross over to active therapy.
820937|NCT01324401|P2|Participant Flow|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
820938|NCT01324401|P1|Participant Flow|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
820939|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
820940|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
820941|NCT01324401|O2|Outcome|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
820942|NCT01324401|O1|Outcome|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
820943|NCT01324401|E2|Reported Event|Peanut OIT|Peanut flour OIT: Patients will receive daily escalating dosages as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
820944|NCT01324401|E1|Reported Event|Control - Crossover|The subjects enrolled in the observational control group will have follow-up visits every 6 months. Each visit will involve a medical history and physical examination. After year 1, they will be offered to cross-over to active therapy.
820945|NCT01324388|B4|Baseline|Total|Total of all reporting groups
820946|NCT01324388|B3|Baseline|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
820947|NCT01324388|B2|Baseline|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820948|NCT01324388|B1|Baseline|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820949|NCT01324388|P4|Participant Flow|Part 2: LY2189265 + Metoprolol First, Then LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 and on Day 1 of Treatment 1 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 1 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 7 of Treatment 2 to Day 1 of Treatment 1 in Part 2 of the study)."
820950|NCT01324388|P3|Participant Flow|Part 2: LY2189265 First, Then LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 and on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 1 through 7 of Treatment 2 in Part 2 of the study.~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 of Treatment 1 to Day 1 of Treatment 2 in Part 2 of the study)."
820951|NCT01324388|P2|Participant Flow|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820976|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
820952|NCT01324388|P1|Participant Flow|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820953|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 ; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
820954|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol (Treatment 2)|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
820955|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820956|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820957|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
820958|NCT01324388|O1|Outcome|Part 2: LY2189265 + Metoprolol Crossover|"Participants received 2 treatments in Part 2 of the study:~Treatment 1: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1~Treatment 2: LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5; Metoprolol: 100 mg, oral, on Days 1 through 7~Participants were randomized to 1 of 2 treatment sequences in Part 2 of the study:~Treatment Sequence A: Treatment 1, Treatment 2~Treatment Sequence B: Treatment 2, Treatment 1~There was a washout period of at least 21 days between the LY2189265 and metoprolol doses of each treatment period (Day 1 to Day 1 for Treatment Sequence A and Day 7 to Day 1 for Treatment Sequence B)."
820959|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820960|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820961|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820962|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820963|NCT01324388|O2|Outcome|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820964|NCT01324388|O1|Outcome|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820965|NCT01324388|E5|Reported Event|Part 2: LY2189265 + Metoprolol|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 5 of Treatment 2 in Part 2 of the study.~Metoprolol: 100 mg, oral, on Days 5 through 7 of Treatment 2 in Part 2 of the study.~Time frame: Day 5 to end of Treatment 2"
820966|NCT01324388|E4|Reported Event|Part 2: Metoprolol|"Metoprolol: 100 milligrams (mg), oral, on Days 1 through 4 of Treatment 2 in Part 2 of the study.~Time frame: Days 1 to 4 of Treatment 2"
820967|NCT01324388|E3|Reported Event|Part 2: LY2189265|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Day 1 of Treatment 1 in Part 2 of the study.~Time frame: Treatment 1"
820968|NCT01324388|E2|Reported Event|Part 1: Placebo + Lisinopril|"Placebo: 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820969|NCT01324388|E1|Reported Event|Part 1: LY2189265 + Lisinopril|"LY2189265 (dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), on Days 1, 8, 15, and 22 of Part 1 of the study.~Lisinopril: Dose as prescribed by participant's established course of therapy, oral, daily dosing throughout Part 1 of the study."
820970|NCT01324349|B3|Baseline|Total|Total of all reporting groups
820971|NCT01324349|B2|Baseline|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
820972|NCT01324349|B1|Baseline|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
820973|NCT01324349|P2|Participant Flow|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®
821685|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
820977|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
820978|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
820979|NCT01324349|O2|Outcome|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
820980|NCT01324349|O1|Outcome|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
820981|NCT01324349|E2|Reported Event|Fibrin Sealant (TachoSil®)|Subject received the topical hemostat TachoSil®.
820982|NCT01324349|E1|Reported Event|Veriset Hemostatic Patch|Subject received the topical hemostat Veriset Hemostatic Patch
820983|NCT01324323|B1|Baseline|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
820984|NCT01324323|P1|Participant Flow|Romidepsin and Rifampin|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.~Rifampin 600 mg oral once daily on Days 4-8"
820985|NCT01324323|O1|Outcome|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Days 1 and 8. Rifampin 600 mg oral once daily on Days 4-8
820986|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
820987|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
820988|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
820989|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
820990|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
820991|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
820992|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
820993|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
820994|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8
820995|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.
820996|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8.
820997|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1
820998|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600 mg oral once daily on Days 4-8
820999|NCT01324323|O1|Outcome|Romidepsin Day 1|"Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1.~Rifampin 600 mg oral once daily on Days 4-8"
821000|NCT01324323|O2|Outcome|Romidepsin and Rifampin Day 8|Romidepsin 14mg/m^2 intravenous infused over 4 hours on Day 8. Rifampin 600mg oral once daily on Days 4-8.
821001|NCT01324323|O1|Outcome|Romidepsin Day 1|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
821002|NCT01324323|E1|Reported Event|Romidepsin Plus Rifampin|Romidepsin 14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8 and Rifampin 600 mg oral once daily on Days 4-8.
821003|NCT01324128|B3|Baseline|Total|Total of all reporting groups
821004|NCT01324128|B2|Baseline|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
821005|NCT01324128|B1|Baseline|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
821006|NCT01324128|P4|Participant Flow|PA21-1 (LD) Stage 2|PA21-1 (1.25 g/day) Low Dose (LD) comparator for Stage 2.
821007|NCT01324128|P3|Participant Flow|PA21 (MD) Stage 2|PA21 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1
821008|NCT01324128|P2|Participant Flow|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
821009|NCT01324128|P1|Participant Flow|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
821010|NCT01324128|O2|Outcome|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
821011|NCT01324128|O1|Outcome|PA21 (2.5 g Tablet) Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
821012|NCT01324128|O2|Outcome|PA21-1 (LD) Stage 2|PA21-1 Low Dose (LD) comparator (1.25 g/day) for Stage 2
821013|NCT01324128|O1|Outcome|PA21 (MD) Stage 2|PA21 Stage 2 Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
821014|NCT01324128|E4|Reported Event|PA21 (MD) Stage 2|PA21 (2.5g tablet) Maintenance Dose (MD). Continuation of same dose that was being received at the end of Stage 1.
821015|NCT01324128|E3|Reported Event|PA21-1 (LD) Stage 2|PA21-1 (1.25 g tablet). Low Dose (LD) comparator (1.25 g/day) for Stage 2.
821016|NCT01324128|E2|Reported Event|Sevelamer Carbonate Stage 1|Sevelamer carbonate. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
821017|NCT01324128|E1|Reported Event|PA21 Stage 1|PA21 (2.5 g tablet). Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
821018|NCT01324102|B3|Baseline|Total|Total of all reporting groups
821019|NCT01324102|B2|Baseline|Wait List Control|Wait List control: The wait list control did not receive an intervention.
821020|NCT01324102|B1|Baseline|Yoga Therapy Intervention|Intervention: Yoga therapy was 8 week class for two times per week
821021|NCT01324102|P2|Participant Flow|Wait List Control|Wait List control received no intervention for 8 weeks, then joined the yoga group
821022|NCT01324102|P1|Participant Flow|Yoga Therapy Intervention|"Intervention~Yoga therapy received an 8 week 2x weekly Yoga therapy class."
821023|NCT01324102|O2|Outcome|Post Group Values|Patient Reported Outcome Measurement System values for all participants after participation in 8 session Yoga Therapy with home practice
821024|NCT01324102|O1|Outcome|Pre Group Values|Patient Reported Outcome Measurement System values for all participants prior to participation in 8 session Yoga Therapy with home practice
821025|NCT01324102|E3|Reported Event|Wait List on Yoga Therapy|"Received yoga therapy after an 8 week wait.~No participants were hospitalized."
821026|NCT01324102|E2|Reported Event|Wait List|"Received no yoga therapy for 8 weeks while the intervention group received yoga therapy~One participant in the Arm 2, Wait list, age 65, was hospitalized. His principal diagnosis was pneumonia."
821027|NCT01324102|E1|Reported Event|Yoga Therapy|"Received yoga therapy.~One participant in the Arm 1, Yoga therapy, age 80, was hospitalized. His principal diagnosis was influenza."
821028|NCT01323998|B6|Baseline|Total|Total of all reporting groups
821029|NCT01323998|B5|Baseline|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821030|NCT01323998|B4|Baseline|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821031|NCT01323998|B3|Baseline|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821032|NCT01323998|B2|Baseline|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821033|NCT01323998|B1|Baseline|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821034|NCT01323998|P5|Participant Flow|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821035|NCT01323998|P4|Participant Flow|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821036|NCT01323998|P3|Participant Flow|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821037|NCT01323998|P2|Participant Flow|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821038|NCT01323998|P1|Participant Flow|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 milligram (mg), or a procedure code for prostate surgery
821039|NCT01323998|O5|Outcome|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821040|NCT01323998|O4|Outcome|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821041|NCT01323998|O3|Outcome|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821042|NCT01323998|O2|Outcome|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821043|NCT01323998|O1|Outcome|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821044|NCT01323998|E5|Reported Event|5ARI Plus AB Combination Therapy|Males aged 50 and older who had a new pharmacy claim for 5ARI and a subsequent claim for AB within one year of the initial 5ARI claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821045|NCT01323998|E4|Reported Event|AB Plus 5ARI Combination, Therapy, Delayed 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI between 30 days and one year of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821076|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821046|NCT01323998|E3|Reported Event|AB Plus 5ARI Combination Therapy, Early 5ARI Starters|Males aged 50 and older who had a new pharmacy claim for AB and a subsequent claim for 5ARI within 30 days of the initial AB claim. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821047|NCT01323998|E2|Reported Event|5 Alpha Reductase Inhibitor (5ARI) Monotherapy|Males aged 50 and older who had a new pharmacy claim for 5ARI monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821048|NCT01323998|E1|Reported Event|Alpha-blocker (AB) Monotherapy|Males aged 50 and older who had a new pharmacy claim for AB monotherapy. Participants were excluded if they had a diagnosis of prostate or bladder cancer, a treatment history for male-pattern baldness with finasteride 1 mg, or a procedure code for prostate surgery
821049|NCT01323920|B1|Baseline|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
821050|NCT01323920|P1|Participant Flow|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
821051|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
821052|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
821053|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
821054|NCT01323920|O1|Outcome|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
821055|NCT01323920|E1|Reported Event|Velcade/Tac/MTX|"Drug: Bortezomib, Tacrolimus, Methotrexate~Other Names:~Velcade~Bortezomib 1.3 mg/m^2 IV Tacrolimus 0.05 mg/kg PO bid Methotrexate 15 mg/m^2 IV"
821056|NCT01323855|B6|Baseline|Total|Total of all reporting groups
821057|NCT01323855|B5|Baseline|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821058|NCT01323855|B4|Baseline|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821059|NCT01323855|B3|Baseline|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821060|NCT01323855|B2|Baseline|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821061|NCT01323855|B1|Baseline|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821062|NCT01323855|P5|Participant Flow|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821063|NCT01323855|P4|Participant Flow|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821064|NCT01323855|P3|Participant Flow|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821065|NCT01323855|P2|Participant Flow|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821066|NCT01323855|P1|Participant Flow|Part 1: Severe Renal Impairment|Participants with severe chronic renal impairment (CRI), defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821067|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821068|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821069|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821070|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821071|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821072|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821073|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821074|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821075|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821136|NCT01323777|O4|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821077|NCT01323855|O5|Outcome|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821078|NCT01323855|O4|Outcome|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821079|NCT01323855|O3|Outcome|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821080|NCT01323855|O2|Outcome|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821081|NCT01323855|O1|Outcome|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821082|NCT01323855|E5|Reported Event|Part 2: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821083|NCT01323855|E4|Reported Event|Part 1: Normal Renal Function|Participants with normal renal function, defined as creatinine clearance of >80 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821084|NCT01323855|E3|Reported Event|Part 2: Mild Renal Impairment|Participants with mild CRI, defined as creatinine clearance of ≥50 and ≤80 mL/min/1.73m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821085|NCT01323855|E2|Reported Event|Part 2: Moderate Renal Impairment|Participants with moderate CRI defined as creatinine clearance of ≥30 and <50 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821086|NCT01323855|E1|Reported Event|Part 1: Severe Renal Impairment|Participants with severe CRI, defined as creatinine clearance of <30 mL/min/1.73 m^2, were treated with a single tablet of 5 mg preladenant, administered orally
821087|NCT01323790|B4|Baseline|Total|Total of all reporting groups
821088|NCT01323790|B3|Baseline|Placebo|Placebo QD, oral treatment
821089|NCT01323790|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821090|NCT01323790|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821091|NCT01323790|P3|Participant Flow|Placebo|Placebo QD, oral treatment
821092|NCT01323790|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821093|NCT01323790|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821094|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821095|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821096|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821097|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821098|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821099|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821100|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821101|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821102|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821103|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821104|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821105|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821106|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821107|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821108|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821109|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821110|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821111|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821112|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821113|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821114|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821115|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821116|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821117|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821118|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821119|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821120|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821121|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821122|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821123|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821124|NCT01323790|O3|Outcome|Placebo|Placebo QD, oral treatment
821125|NCT01323790|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
821126|NCT01323790|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
821127|NCT01323790|E3|Reported Event|Placebo|
821128|NCT01323790|E2|Reported Event|NKTR-118 25 mg|
821129|NCT01323790|E1|Reported Event|NKTR-118 12.5 mg|
821130|NCT01323777|B1|Baseline|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
821131|NCT01323777|P1|Participant Flow|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
821132|NCT01323777|O3|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821133|NCT01323777|O2|Outcome|Day 120-180|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821134|NCT01323777|O1|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821135|NCT01323777|O5|Outcome|Day 330-420|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821137|NCT01323777|O3|Outcome|Day 30-60|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821138|NCT01323777|O2|Outcome|Day 7-14|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821139|NCT01323777|O1|Outcome|Day 1-2|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism
821140|NCT01323777|E1|Reported Event|ReSTOR +3.0|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
821141|NCT01323673|B3|Baseline|Total|Total of all reporting groups
821142|NCT01323673|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821143|NCT01323673|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821144|NCT01323673|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821145|NCT01323673|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821146|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821147|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821148|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821149|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821150|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821151|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821152|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821153|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821154|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821155|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821156|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821157|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821158|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821159|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821160|NCT01323673|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821161|NCT01323673|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821162|NCT01323673|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 g per week
821163|NCT01323673|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobestasol propionate, applied twice daily (morning and evening [BD]) for two weeks using the smallest amount of study product necessary to cover all affected areas, up to a maximum dosage of 50 grams (g) per week
821164|NCT01323660|B1|Baseline|All Study Treatments|Participants were randomized to receive a sequence consisting of 2 of the following treatments: UMEC/VI 125/25 µg , UMEC/VI 62.5/25 µg , UMEC 125 µg , UMEC 62.5 µg , VI 25 µg , or placebo QD via a DPI. Each treatment was administered in the morning for 12 weeks. The treatment periods were seperated by 14-day washout period.
821165|NCT01323660|P6|Participant Flow|UMEC 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821166|NCT01323660|P5|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821167|NCT01323660|P4|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 12 weeks.
821168|NCT01323660|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821169|NCT01323660|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 12 weeks.
821170|NCT01323660|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 12weeks.
821171|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821172|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821173|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
821174|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821175|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
821176|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
821177|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821178|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821179|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
821180|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821181|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
821182|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
821183|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821184|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821185|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
821186|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821187|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
821188|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
821189|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821190|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821191|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
821192|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821193|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
821194|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
821195|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821196|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821197|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
821198|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821199|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
821200|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
821201|NCT01323660|O6|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821202|NCT01323660|O5|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821203|NCT01323660|O4|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
821204|NCT01323660|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821205|NCT01323660|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
821206|NCT01323660|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
821207|NCT01323660|E6|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 12 weeks.
821208|NCT01323660|E5|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 12 weeks.
821209|NCT01323660|E4|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 12 weeks.
821210|NCT01323660|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI in the morning for 12 weeks.
821211|NCT01323660|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 12 weeks.
821212|NCT01323660|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 12 weeks.
821213|NCT01323647|B3|Baseline|Total|Total of all reporting groups
821214|NCT01323647|B2|Baseline|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
821215|NCT01323647|B1|Baseline|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821268|NCT01323582|P1|Participant Flow|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
821216|NCT01323647|P2|Participant Flow|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
821217|NCT01323647|P1|Participant Flow|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821218|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
821219|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821220|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821221|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821222|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821223|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
821224|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821225|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821226|NCT01323647|O2|Outcome|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
821227|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821228|NCT01323647|O1|Outcome|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821229|NCT01323647|E2|Reported Event|Control Group|Subjects previously primed with 3 doses of Chinese oral poliovirus vaccine (OPV) in the primary study and who received a dose of Infanrix-Hib™ vaccine in the current study.
821230|NCT01323647|E1|Reported Event|Poliorix Group|Subjects previously primed with 3 doses of Poliorix™ vaccine in the primary study and who received a booster dose of Poliorix™ vaccine co-administered with Infanrix-Hib™ vaccine in the current study.
821231|NCT01323634|B3|Baseline|Total|Total of all reporting groups
821232|NCT01323634|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821233|NCT01323634|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821234|NCT01323634|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821235|NCT01323634|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821236|NCT01323634|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
821237|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821238|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821239|NCT01323634|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821318|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821319|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821240|NCT01323634|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821241|NCT01323634|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821242|NCT01323634|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821243|NCT01323621|B3|Baseline|Total|Total of all reporting groups
821244|NCT01323621|B2|Baseline|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821245|NCT01323621|B1|Baseline|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821246|NCT01323621|P3|Participant Flow|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821247|NCT01323621|P2|Participant Flow|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821248|NCT01323621|P1|Participant Flow|Placebo + Salbutamol|Participants were instructed to take single-blind placebo (ACCUHALER/DISKUS and Novel Dry Powder Inhaler [NDPI]): one inhalation each morning from each device, and one inhalation from the ACCUHALER/DISKUS in the evening. In addition, all participants received supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used on an as-needed basis. Ipratropium bromide alone was permitted, provided that the participant was on a stable dose from Visit 1 (Screening) and remained on the stable dose throughout the study; however, Ipratropium must have been withheld for 4 hours prior to and during each clinic visit.
821249|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821250|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821251|NCT01323621|O2|Outcome|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821252|NCT01323621|O1|Outcome|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821253|NCT01323621|E2|Reported Event|FF/VI 100/25 µg QD|Participants received a Fluticasone Furoate /Vilanterol (FF/VI) 100/25 µg inhalation (available as a dry inhalation powder in two separate strips of FF 100 µg and VI 25 µg) QD in the morning from the NDPI and placebo BID (morning and evening) from the ACCUHALER/DISKUS over the course of 12 weeks.
821254|NCT01323621|E1|Reported Event|FSC 250/50 µg BID|Participants received a Fluticasone Propionate and Salmeterol (FSC) 250/50 microgram (µg) inhalation (available as a combination dry inhalation powder of Fluticasone 250 µg and Salmeterol 50 µg in a single strip) twice daily (BID) (morning and evening) from the ACCUHALER/DISKUS and placebo once daily (QD) in the morning from the NDPI over the course of 12 weeks.
821255|NCT01323595|B3|Baseline|Total|Total of all reporting groups
821256|NCT01323595|B2|Baseline|Sugar Pill|"Sugar pill for 6 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
821257|NCT01323595|B1|Baseline|Celecoxib|"Celecoxib will be given for 6 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
821258|NCT01323595|P2|Participant Flow|Sugar Pill|"Sugar pill for 5 days after surgery.~Sugar Pill : Sugar pill PO BID x 6 days"
821259|NCT01323595|P1|Participant Flow|Celecoxib|"Celecoxib will be given for 5 days after surgery~Celecoxib : Celecoxib 200mg PO BID x 6 days"
821260|NCT01323595|O2|Outcome|Celecoxib|
821261|NCT01323595|O1|Outcome|Placebo Treatment|
821262|NCT01323595|E2|Reported Event|Celecoxib|
821263|NCT01323595|E1|Reported Event|Placebo Treatment|
821264|NCT01323582|B3|Baseline|Total|Total of all reporting groups
821265|NCT01323582|B2|Baseline|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
821266|NCT01323582|B1|Baseline|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
821267|NCT01323582|P2|Participant Flow|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
821269|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
821270|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
821271|NCT01323582|O1|Outcome|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
821272|NCT01323582|O1|Outcome|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
821273|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
821274|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
821275|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
821276|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
821277|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
821278|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
821279|NCT01323582|O2|Outcome|Azithromycin Then Erythromycin|Azithromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Erythromycin is given for 4 weeks (Weeks 8-11).
821280|NCT01323582|O1|Outcome|Erythromycin First Then Azithromycin|Erythromycin is given for 4 weeks (1-4), there is a 3 week washout (5-7), then Azithromycin is given for 4 weeks (Weeks 8-11).
821281|NCT01323582|E2|Reported Event|Azithromycin|The dose of Azithromycin given was previously determined based on our dose-response analysis in 10 healthy subjects to be 50 mg. The total daily dosage of Azithromycin given therefore was 150 mg which was divided three times daily and administered as 50mg/5ml given three times a day as elixir orally, similar to the erythromycin volume.
821282|NCT01323582|E1|Reported Event|Erythromycin|"200mg/5ml elixir administered orally three times a day half an hour prior to meals.~Erythromycin: 200mg/5ml elixir administered orally three times a day half an hour prior to meals."
821283|NCT01323478|B1|Baseline|Vortioxetine 15 or 20 mg/Day|
821284|NCT01323478|P1|Participant Flow|Vortioxetine 15 or 20 mg/Day|
821285|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821286|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821287|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821288|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821289|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821290|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821291|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821292|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821293|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821294|NCT01323478|O1|Outcome|Vortioxetine 15 or 20 mg/Day|
821295|NCT01323478|E1|Reported Event|Vortioxetine 15 or 20 mg/Day|
821296|NCT01323387|B1|Baseline|Treatment|Interbody fusions with Anterior Plating
821297|NCT01323387|P1|Participant Flow|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
821298|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
821299|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
821300|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
821301|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
821302|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
821303|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
821304|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody Fusion with Anterior Plating
821305|NCT01323387|O1|Outcome|Anterior Lumbar Interbody Fusion|Interbody fusions with Anterior Plating
821306|NCT01323387|E1|Reported Event|Treatment|"Interbody fusions with Anterior Plating~Interbody Fusion: allograft spacer + anterior plate"
821307|NCT01323270|B3|Baseline|Total|Total of all reporting groups
821308|NCT01323270|B2|Baseline|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821309|NCT01323270|B1|Baseline|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821310|NCT01323270|P2|Participant Flow|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821311|NCT01323270|P1|Participant Flow|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821312|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821313|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821314|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821315|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821316|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821317|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821320|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month
821321|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821322|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821323|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821324|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821325|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821326|NCT01323270|O2|Outcome|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821327|NCT01323270|O1|Outcome|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821328|NCT01323270|E2|Reported Event|Group 2: Saline+Repevax|Randomized to receive Saline at 0-,2-6-month and Repevax at 0-month.
821329|NCT01323270|E1|Reported Event|Group 1: rLP2086 + Repevax|Randomized to receive rLP2086 at 0-,2-6-month and Repevax at 0-month.
821330|NCT01323192|B3|Baseline|Total|Total of all reporting groups
821331|NCT01323192|B2|Baseline|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821332|NCT01323192|B1|Baseline|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821333|NCT01323192|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821334|NCT01323192|P1|Participant Flow|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821335|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821336|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821337|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821338|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821339|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821340|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821341|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821342|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821343|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821344|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821345|NCT01323192|O2|Outcome|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821346|NCT01323192|O1|Outcome|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821347|NCT01323192|E2|Reported Event|Placebo|Participants received matching placebo orally once daily for 8 weeks.
821348|NCT01323192|E1|Reported Event|JNS001|Participants received JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
821349|NCT01323140|B1|Baseline|Treatment|
821350|NCT01323140|P1|Participant Flow|Treatment|
821351|NCT01323140|O1|Outcome|Treatment|As specified in the Protocol, subjects were dose-titrated during treatment and subjects at all resulting dose levels were pooled for primary efficacy analysis. After dose-titration, 20 subjects were receiving TMTS at dose level B (one 48 cm2 TMTS) and 18 subjects were receiving TMTS at dose level C (one 48 cm2 and one 28 cm2 TMTS). See also Arm description.
821352|NCT01323140|E1|Reported Event|Treatment|
821353|NCT01323010|B3|Baseline|Total|Total of all reporting groups
821354|NCT01323010|B2|Baseline|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821355|NCT01323010|B1|Baseline|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821356|NCT01323010|P2|Participant Flow|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821357|NCT01323010|P1|Participant Flow|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821358|NCT01323010|O3|Outcome|Arg16Arg Patients|Patients carrying the Arg16Arg genotype
821359|NCT01323010|O2|Outcome|Gly16Gly Patients|Patients carrying the Gly16Gly genotype
821360|NCT01323010|O1|Outcome|Arg16Gly Patients|Patients carrying the Arg16Gly genotype
821361|NCT01323010|O2|Outcome|No Rhinovirus Detected|patients with no rhinovirus detected by PCR
821362|NCT01323010|O1|Outcome|Rhinovirus Detected|patients with rhinovirus detected by PCR
821363|NCT01323010|O2|Outcome|No Virus Detected|patients with no virus detected by PCR
821364|NCT01323010|O1|Outcome|Virus Detected|patients with any virus detected by PCR
821365|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821366|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821367|NCT01323010|O2|Outcome|Control Group|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821368|NCT01323010|O1|Outcome|Experimental Group|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821369|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821370|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821371|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821372|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821373|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821374|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821375|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821376|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821377|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821378|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821379|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821380|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821381|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821382|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821383|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821384|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821385|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821386|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821387|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821388|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821415|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
821389|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821390|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821391|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821392|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821393|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821394|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821395|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing will be dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group will receive 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821396|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing will be individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group will receive higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821397|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821398|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821399|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was individualized according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821400|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821401|NCT01323010|O2|Outcome|Albuterol - Lower Dose (Control)|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821402|NCT01323010|O1|Outcome|Albuterol - Higher Dose (Experimental)|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821403|NCT01323010|E2|Reported Event|Control Group|"Dosing was dived according to consensus recommendations in only two categories according to body weight~Albuterol - Control: The Control group received 600 mcg for those with weight under 25kg and 1200 mcg for those grater than 25 kg"
821404|NCT01323010|E1|Reported Event|Experimental Group|"Dosing was individualized in four categories according to body weight~Albuterol - Experimental: The Experimental group received higher doses of albuterol in the first hour: up to 15 kg of weight: 900 mcg; 15 to 20 kg: 1200 mcg; 20 to 25 kg: 1500; more than 25 kg: 1800 mcg"
821405|NCT01322971|B3|Baseline|Total|Total of all reporting groups
821406|NCT01322971|B2|Baseline|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
821407|NCT01322971|B1|Baseline|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
821408|NCT01322971|P2|Participant Flow|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
821409|NCT01322971|P1|Participant Flow|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
821410|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
821411|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
821412|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
821413|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
821414|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
821416|NCT01322971|O2|Outcome|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
821417|NCT01322971|O1|Outcome|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
821418|NCT01322971|E2|Reported Event|Placebo|"Patients randomized to the placebo arm will receive placebo orally twice daily for seven days(control arm~Placebo: Placebo will be administered orally twice daily for seven days"
821419|NCT01322971|E1|Reported Event|Metronidazole|"Patients randomized to the metronidazole arm will receive metronidazole 500mg orally twice daily for seven days.~Metronidazole: Metronidazole 500mg orally twice daily for seven days"
821420|NCT01322945|B3|Baseline|Total|Total of all reporting groups
821421|NCT01322945|B2|Baseline|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
821422|NCT01322945|B1|Baseline|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
821423|NCT01322945|P2|Participant Flow|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
821424|NCT01322945|P1|Participant Flow|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
821425|NCT01322945|O2|Outcome|Control Group|First 10 patients enrolled undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
821426|NCT01322945|O1|Outcome|Endonasal Group|First 12 patients enrolled undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
821427|NCT01322945|O2|Outcome|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
821428|NCT01322945|O1|Outcome|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
821429|NCT01322945|E2|Reported Event|Control Group|Patients undergoing any neurosurgical procedure requiring general anesthesia that did not involve the endonasal corridor, such as spinal decompression procedures, craniotomies for trigeminal neuralgia, or shunting procedures.
821430|NCT01322945|E1|Reported Event|Endonasal Group|Patients undergoing endonasal surgery for anterior skull base tumors, pituitary tumors, and skull base spinal fluid leaks using endonasal techniques.
821431|NCT01322841|B3|Baseline|Total|Total of all reporting groups
821432|NCT01322841|B2|Baseline|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
821433|NCT01322841|B1|Baseline|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
821434|NCT01322841|P2|Participant Flow|CHICA Placebo|This arm had CHICA but no additional module CHICA Placebo: This was CHICA without the screening module
821435|NCT01322841|P1|Participant Flow|CHICA Diagnosis Module|This arm had the CHICA screening module turned on CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
821436|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
821437|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
821438|NCT01322841|O2|Outcome|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
821439|NCT01322841|O1|Outcome|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
821440|NCT01322841|E2|Reported Event|CHICA Placebo|"This arm had CHICA but no additional module~CHICA Placebo: This was CHICA without the screening module"
821441|NCT01322841|E1|Reported Event|CHICA Diagnosis Module|"This arm had the CHICA screening module turned on~CHICA diagnosis module: The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia"
821442|NCT01322815|B3|Baseline|Total|Total of all reporting groups
821443|NCT01322815|B2|Baseline|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
821444|NCT01322815|B1|Baseline|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
821445|NCT01322815|P2|Participant Flow|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
821446|NCT01322815|P1|Participant Flow|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
821447|NCT01322815|O2|Outcome|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
821448|NCT01322815|O1|Outcome|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
821449|NCT01322815|E2|Reported Event|GI-4000 and Bevacizumab|"maintenance with GI-4000 and bevacizumab for patients who have completed first-line chemotherapy~GI-4000: 40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks"
821450|NCT01322815|E1|Reported Event|Chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks~chemotherapy and GI-4000: Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
821451|NCT01322633|B3|Baseline|Total|Total of all reporting groups
821452|NCT01322633|B2|Baseline|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
821453|NCT01322633|B1|Baseline|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
821454|NCT01322633|P2|Participant Flow|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
821455|NCT01322633|P1|Participant Flow|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
821456|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
821457|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
821458|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
821459|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
821460|NCT01322633|O2|Outcome|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
821461|NCT01322633|O1|Outcome|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
821462|NCT01322633|E2|Reported Event|Other Proton Pump Inhibitors (PPI)|Participants enrolled in KPNC health maintenance organization who received treatment with any PPI other than pantoprazole (any combination of omeprazole, lansoprazole, rabeprazole, or esomeprazole) as per standard clinical practice for at least 240 days within a 12-month period during 8 years (from 1996 to 2003) before the start of study, were observed for up to 7.5 years.
821463|NCT01322633|E1|Reported Event|Pantoprazole|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received treatment with pantoprazole (Protonix, pantoprazole sodium) tablets as per standard clinical practice for at least 240 days within a 12-month period during 4 years (from 2000 to 2003) before the start of study, were observed for up to 7.5 years.
821464|NCT01322607|B3|Baseline|Total|Total of all reporting groups
821465|NCT01322607|B2|Baseline|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
821466|NCT01322607|B1|Baseline|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
821467|NCT01322607|P2|Participant Flow|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
821468|NCT01322607|P1|Participant Flow|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
821469|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
821470|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
821471|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
821472|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
821473|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
821474|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
821475|NCT01322607|O2|Outcome|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
821476|NCT01322607|O1|Outcome|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
821477|NCT01322607|E2|Reported Event|Arm 2: Low-Intensity Program|"Low-intensity lifestyle intervention (group exercise)~Low-intensity Lifestyle Intervention: A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength."
821478|NCT01322607|E1|Reported Event|Arm 1: High-Intensity Program|"High-intensity treadmill-based exercise~High-intensity Treadmill Exercise: High-intensity treadmill walking program"
821479|NCT01322594|B7|Baseline|Total|Total of all reporting groups
821480|NCT01322594|B6|Baseline|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821481|NCT01322594|B5|Baseline|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821482|NCT01322594|B4|Baseline|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821483|NCT01322594|B3|Baseline|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821484|NCT01322594|B2|Baseline|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821485|NCT01322594|B1|Baseline|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821486|NCT01322594|P6|Participant Flow|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821487|NCT01322594|P5|Participant Flow|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821488|NCT01322594|P4|Participant Flow|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821489|NCT01322594|P3|Participant Flow|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821490|NCT01322594|P2|Participant Flow|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821491|NCT01322594|P1|Participant Flow|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821492|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821493|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821494|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821495|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821496|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821497|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821498|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821499|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821500|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821501|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821502|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821503|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821504|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821505|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821506|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821507|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821508|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821802|NCT01320202|B3|Baseline|Total|Total of all reporting groups
821509|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821510|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821511|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821512|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821513|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821514|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821515|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821516|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821517|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821518|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821519|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821520|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821521|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821522|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821523|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821524|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821525|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821526|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821527|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821528|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821529|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821530|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821531|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821532|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821533|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821534|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821535|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821536|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821537|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821538|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821539|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821540|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821541|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821542|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821543|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821544|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821545|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821546|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821547|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821548|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821549|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821550|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821551|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821552|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821553|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821554|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821555|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821556|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821557|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821558|NCT01322594|O6|Outcome|Placebo|Placebo administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821559|NCT01322594|O5|Outcome|MEDI2338 1000 MG|MEDI2338 (1000 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821560|NCT01322594|O4|Outcome|MEDI2338 300 MG|MEDI2338 (300 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821561|NCT01322594|O3|Outcome|MEDI2338 100 MG|MEDI2338 (100 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821562|NCT01322594|O2|Outcome|MEDI2338 30 MG|MEDI2338 (30 mg) administered as a single, fixed IV dose over a minimum of 60 minutes using an infusion pump
821563|NCT01322594|O1|Outcome|MEDI2338 10 MG|MEDI2338 (10 mg) administered as a single, fixed intravenous (IV) dose over a minimum of 60 minutes using an infusion pump
821564|NCT01322594|E6|Reported Event|MEDI2338 1000 MG|
821565|NCT01322594|E5|Reported Event|MEDI2338 300 MG|
821566|NCT01322594|E4|Reported Event|MEDI2338 100 MG|
821567|NCT01322594|E3|Reported Event|MEDI2338 30 MG|
821568|NCT01322594|E2|Reported Event|MEDI2338 10 MG|
821569|NCT01322594|E1|Reported Event|Placebo|
821570|NCT01322386|B3|Baseline|Total|Total of all reporting groups
821571|NCT01322386|B2|Baseline|Oral Vancomycin - PSC|Enrolled- 11, Participated - 10 ,Completed - 9 (Based on Annual Progress Report in Oct 2010)
821572|NCT01322386|B1|Baseline|Oral Vancomycin-BIliary Atresia|Enrolled- 10, Participated - 10,Completed - 10 (Based on Annual Progress Report in Oct 2010)
821573|NCT01322386|P2|Participant Flow|Oral Vancomycin/ Primary Sclerosing Cholangitis|Vancomycin: Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months. Initially 10 children with Primary Sclerosing Cholangitis (PSC) were planned for this study to determine if there was clinical response to oral vancomycin.
821574|NCT01322386|P1|Participant Flow|Oral Vancomycin-Biliary Atresia|Vancomycin: Oral 50mg/Kg per day for three months. Initially 10 infants with Biliary Atresia (BA) were planned for this study to determine if there was clinical response to oral vancomycin.
821575|NCT01322386|O5|Outcome|Liver Biopsy and/or MRI|BA-N/A , PSC- 8/9 participants showed improvement of liver biopsies and/or MRI on Vancomycin.
821576|NCT01322386|O4|Outcome|Colon Biopsies|BA - N/A , PSC - 8/8- who had colonoscopies with colon biopsies showed improvement on Vancomycin therapy.
821577|NCT01322386|O3|Outcome|Liver Biopsy|BA - N/A , PSC - 4/4 who had Liver biopsies showed improvement on Vancomycin therapy.
821578|NCT01322386|O2|Outcome|MRI / MRCP|BA-N/A, PSC - 7/7 showed improvement on Vancomycin therapy.
821579|NCT01322386|O1|Outcome|Liver Blood Test|BA -10/10 , PSC - 9/9 - All had improvement on Vancomycin therapy.
821580|NCT01322386|E1|Reported Event|BA/PSC -Oral Vancomycin|Oral Vancomycin is commercially available (Vancocin, ViroPharma Inc.) for treatment of gastrointestinal infection such as, Clostridium difficile infection. In fact, our published observation of using oral vancomycin in treating PSC was an incidental finding to our treatment for Cl. Difficile gastrointestinal infection in a child with PSC (J Pediatr Gastroenterol Nutr 27:580-3, 1998). Since oral vancomycin is poorly absorbed, no serious adverse events were anticipated in this study.
821581|NCT01322360|B1|Baseline|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
821582|NCT01322360|P1|Participant Flow|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
821583|NCT01322360|O1|Outcome|Morphine Sulfate|"oral solution (10 mg/5 mL or 20 mg/5 mL) or tablets (15 mg or 30 mg)given based on based on the current pediatric prescribing guidelines~Morphine Sulfate"
821584|NCT01322360|O1|Outcome|Morphine Sulfate|Subjects received morphine sulfate either as oral solution or tablet.
821585|NCT01322360|E1|Reported Event|Morphine Sulfate|Morphine sulfate oral solution and Morphine sulfate tablets
821586|NCT01322347|B3|Baseline|Total|Total of all reporting groups
821587|NCT01322347|B2|Baseline|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821588|NCT01322347|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821589|NCT01322347|P2|Participant Flow|Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821590|NCT01322347|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821591|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821592|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821593|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821594|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821595|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821596|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821597|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821598|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821599|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821600|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821601|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821602|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821603|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821604|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821605|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821606|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821607|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821608|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821609|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821610|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821611|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821612|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821613|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821614|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821615|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821616|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821617|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821618|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821619|NCT01322347|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821620|NCT01322347|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821621|NCT01322347|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP)|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
821622|NCT01322347|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
821623|NCT01322347|E1|Reported Event|Stage 2 Standard Dialysate (Placebo)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
821624|NCT01322048|B3|Baseline|Total|Total of all reporting groups
821625|NCT01322048|B2|Baseline|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
821626|NCT01322048|B1|Baseline|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
821627|NCT01322048|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
821628|NCT01322048|P1|Participant Flow|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
821629|NCT01322048|O2|Outcome|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
821630|NCT01322048|O1|Outcome|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
821631|NCT01322048|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo IV q6h and Per Tube q12, both for 7 days"
821632|NCT01322048|E1|Reported Event|Adrenergic Blockade|"Propranolol and Clonidine~IV Propranolol and Per Tube Clonidine: 1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days"
821633|NCT01322022|B3|Baseline|Total|Total of all reporting groups
821634|NCT01322022|B2|Baseline|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
821635|NCT01322022|B1|Baseline|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
821636|NCT01322022|P2|Participant Flow|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
821637|NCT01322022|P1|Participant Flow|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
821638|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
821639|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
821640|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
821641|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
821642|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
821643|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
821644|NCT01322022|O2|Outcome|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
821645|NCT01322022|O1|Outcome|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
821646|NCT01322022|E2|Reported Event|Parent Education|5 Sessions of individual parent education on various topics related to autism (definition, diagnosis, development, therapies, etc.)
821647|NCT01322022|E1|Reported Event|Parent Training|5 sessions of individual parent training to address sleep problems in young children with autism
821648|NCT01322009|B3|Baseline|Total|Total of all reporting groups
821649|NCT01322009|B2|Baseline|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
821650|NCT01322009|B1|Baseline|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
821651|NCT01322009|P2|Participant Flow|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
821679|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
821680|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
821652|NCT01322009|P1|Participant Flow|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
821653|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
821654|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
821655|NCT01322009|O2|Outcome|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
821656|NCT01322009|O1|Outcome|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
821657|NCT01322009|E2|Reported Event|Placebo|"Placebos will be prepared for the two experimental drugs and administered at identical time periods.~Placebo: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline."
821658|NCT01322009|E1|Reported Event|Drug|"Probenecid and N-acetyl cysteine will be administered at standard doses for the first 4 days after TBI.~Probenecid and N-acetyl cysteine: After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos."
821659|NCT01321749|B3|Baseline|Total|Total of all reporting groups
821660|NCT01321749|B2|Baseline|Stroke Secondary Prevention|Procedure:stroke secondary prevention
821661|NCT01321749|B1|Baseline|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
821662|NCT01321749|P2|Participant Flow|Stroke Secondary Prevention|Procedure:stroke secondary prevention
821663|NCT01321749|P1|Participant Flow|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
821664|NCT01321749|O2|Outcome|Stroke Secondary Prevention|Procedure:stroke secondary prevention
821665|NCT01321749|O1|Outcome|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
821666|NCT01321749|E2|Reported Event|Stroke Secondary Prevention|Procedure:stroke secondary prevention
821667|NCT01321749|E1|Reported Event|RIPC+Stroke Secondary Prevension|"Procedure/Surgery: RIPC The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.~Procedure:stroke secondary prevention"
821668|NCT01321723|B4|Baseline|Total|Total of all reporting groups
821669|NCT01321723|B3|Baseline|Placebo|Placebo : matching tablets, once daily
821670|NCT01321723|B2|Baseline|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
821671|NCT01321723|B1|Baseline|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
821672|NCT01321723|P3|Participant Flow|Placebo|Placebo : matching tablets, once daily
821673|NCT01321723|P2|Participant Flow|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily.
821674|NCT01321723|P1|Participant Flow|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily.
821675|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
821676|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
821677|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
821678|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
821686|NCT01321723|O3|Outcome|Placebo|Placebo : matching tablets, once daily
821687|NCT01321723|O2|Outcome|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
821688|NCT01321723|O1|Outcome|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
821689|NCT01321723|E3|Reported Event|Placebo|Placebo : matching tablets, once daily
821690|NCT01321723|E2|Reported Event|PTH Analog Tablets|PTH analog : 5 mg tablets, once daily
821691|NCT01321723|E1|Reported Event|Forsteo (Teriparatide)|Teriparatide : 20 mcg SC Injection, once daily
821692|NCT01321710|B4|Baseline|Total|Total of all reporting groups
821693|NCT01321710|B3|Baseline|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
821694|NCT01321710|B2|Baseline|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
821695|NCT01321710|B1|Baseline|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
821696|NCT01321710|P3|Participant Flow|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
821697|NCT01321710|P2|Participant Flow|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
821698|NCT01321710|P1|Participant Flow|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
821699|NCT01321710|O2|Outcome|Prophylactic Acetaminophen|Infants in this group received prophylactic acetaminophen administered prior to immunization and 4 subsequent doses administered in the 24 hours following immunization.
821700|NCT01321710|O1|Outcome|Standard Immunization Care|Infants in this group received standard immunization care from their health care provider (may or may not have included prophylactic acetaminophen).
821701|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
821702|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
821703|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information.
821704|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
821705|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
821706|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
821707|NCT01321710|O2|Outcome|Sleep Hygiene|Mothers in this group received sleep hygiene information
821708|NCT01321710|O1|Outcome|Dietary Information|Mothers in this group received dietary information for improving sleep.
821709|NCT01321710|E3|Reported Event|Sleep Hygiene & Acetaminophen|"Mothers in this arm receive a sleep hygiene intervention aimed at improving postpartum sleep.~Infants in this arm receive an acetaminophen intervention to minimize sleep disturbance following immunization."
821710|NCT01321710|E2|Reported Event|Sleep Hygiene & Standard Care|"Mothers in this arm receive a sleep hygiene intervention aimed at improving their postpartum sleep.~Infants in this arm receive standard immunization care."
821711|NCT01321710|E1|Reported Event|Dietary Information & Standard Care|"Mothers in this arm receive dietary information aimed at reducing postpartum sleep disturbance.~Infants in this arm receive standard immunization care."
821712|NCT01321697|B1|Baseline|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
821713|NCT01321697|P1|Participant Flow|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
821714|NCT01321697|O1|Outcome|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
821715|NCT01321697|E1|Reported Event|Vulvar Cancer|Routine Leg edema and groin dissection : The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
821716|NCT01321554|B3|Baseline|Total|Total of all reporting groups
821717|NCT01321554|B2|Baseline|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821718|NCT01321554|B1|Baseline|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821719|NCT01321554|P4|Participant Flow|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20mg on 16 Feb 2013.
821720|NCT01321554|P3|Participant Flow|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
821721|NCT01321554|P2|Participant Flow|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821872|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821873|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821722|NCT01321554|P1|Participant Flow|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821723|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821724|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821725|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821726|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821727|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821728|NCT01321554|O2|Outcome|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821729|NCT01321554|O1|Outcome|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821730|NCT01321554|E4|Reported Event|Lenvatinib 20 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib. The starting dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The starting dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013.
821731|NCT01321554|E3|Reported Event|Lenvatinib 24 mg (OOL Lenvatinib Treatment Period)|Placebo treated participants in the Randomization Phase who had progressive disease confirmed by IIR, and who requested treatment with lenvatinib
821732|NCT01321554|E2|Reported Event|Placebo (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821733|NCT01321554|E1|Reported Event|Lenvatinib (Randomization Phase)|Participants received blinded study drug (lenvatinib 24 mg/placebo, orally once daily) in 2:1 ratio until documentation of disease progression (confirmed by IIR), development of unacceptable toxicity, or withdrawal of consent.
821734|NCT01321008|B1|Baseline|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
821735|NCT01321008|P1|Participant Flow|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
821736|NCT01321008|O1|Outcome|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
821737|NCT01321008|E1|Reported Event|Radiation + Chemotherapy|Radiation therapy total dose of 50.4 to 54 Gy over 28 to 30 treatments; CHOP Chemotherapy of Cyclophosphamide 750 mg/m2 intravenous piggyback (IVPB), Doxorubicin 50 mg/m2 IVPB, Vincristine 1.4 mg/m2 (max dose 2 mg) IVPB on Day 1, and Oral Prednisone 100 mg daily days 1-5 for four 21-day cycles.
821738|NCT01320826|B1|Baseline|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
821739|NCT01320826|P1|Participant Flow|Patients Undergoing Colonoscopy|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
821740|NCT01320826|O1|Outcome|Percentage of Females ≥ 50 Years With an Adenoma|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for females 50 years and older undergoing first time colonoscopy."
821741|NCT01320826|O1|Outcome|Percentage of Patients Referred to a Specialist.|The percentage of patients who, after having a colonoscopy, are referred to another specialist for their gastrointestinal problem. A specialist was defined as a physician more specialized than the person performing the colonoscopy, and a referral was counted if the physician, at the time of colonoscopy, sent or anticipated sending the patient to a specialist for any reason, or if the patient believed they were being sent to a specialist.
821742|NCT01320826|O1|Outcome|Procedural Time|Procedural time was defined as the time from the first insertion of the colonoscope until it was removed from the anus, in minutes
821743|NCT01320826|O1|Outcome|Patient Satisfaction With Hospital Experience|Patient satisfaction with hospital experience measured on 7 point Likert scale. 7 is extremely satisfied, 1 is extremely dissatisfied.
821744|NCT01320826|O1|Outcome|Patient Wait Time Satisfaction|"Patient satisfaction with endoscopy wait time will be recorded using a 7 point Likert scale at the time of the patient phone survey. 7 is extremely satisfied and 1 is extremely dissatisfied~minimum score = 1 maximum score = 7"
821803|NCT01320202|B2|Baseline|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 18 months."
821745|NCT01320826|O1|Outcome|Patient Comfort During Colonoscopy|Patient discomfort on 5 point scale 0 is no discomfort; 1 is one or two episodes of discomfort, well tolerated; 2 is more than two episodes of discomfort adequately tolerated; 3 is significant discomfort experienced several times during the procedure; 4 is extreme discomfort experienced frequency throughout the procedure.
821746|NCT01320826|O1|Outcome|Withdraw Times, Minutes|
821747|NCT01320826|O1|Outcome|Colonoscopy Complications|"Potential serious complications of colonoscopy include bleeding, perforation, cardiopulmonary complications secondary to conscious sedation and death.~Potential serious complications will be determined from the case report form (physician reported) and at patient satisfaction phone survey (on average four weeks after colonoscopy).~All potential serious complications of colonoscopy will be externally adjudicated."
821748|NCT01320826|O1|Outcome|Percentage of Males 50 Years and Older Undergoing First Time c|"Percentage of patients with an adenoma = (number of patients who had at least one adenoma detected on colonoscopy / total number of colonoscopies attempted) x 100.~For this specific outcome: we explored this outcome for males 50 years and older undergoing first time colonoscopy."
821749|NCT01320826|O1|Outcome|Adenoma Detection Ratio|The adenoma detection ratio is the number of pathologically verified adenomas per number of colonoscopies performed. Adenoma detection ratio = total number of pathologically confirmed adenomas / number of colonoscopies attempted.
821750|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations|The percentage of successful cecal intubations (adjusted) = total number of colonoscopies performed where cecal intubation was achieved / (total number of colonoscopies attempted -incomplete colonoscopies due to poor bowel preparation, colonic stricture, equipment failure or severe endoscopic colitis)
821751|NCT01320826|O1|Outcome|Percentage of Successful Cecal Intubations (Crude)|The percentage of successful cecal intubations (crude) = (total # of colonoscopies performed where cecal intubation was achieved / total # of colonoscopies attempted) x 100
821752|NCT01320826|E1|Reported Event|Participants.|All patients having a colonoscopy done by an APC-Endo study physician endoscopist were approached at the time of their endoscopy to consent to the post procedure telephone survey.
821753|NCT01320735|B1|Baseline|Advanced PCa|Participants with advanced PCa
821754|NCT01320735|P1|Participant Flow|Advanced Prostate Cancer (PCa)|Participants with advanced PCa
821755|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821756|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821757|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821758|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821759|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821760|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821761|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821762|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821763|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821764|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821765|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821766|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821767|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821768|NCT01320735|O1|Outcome|Advanced PCa|Participants with advanced PCa
821769|NCT01320735|E1|Reported Event|Advanced PCa|Participants with advanced PCa
821770|NCT01320683|B1|Baseline|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
821771|NCT01320683|P1|Participant Flow|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
821772|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
821804|NCT01320202|B1|Baseline|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months."
822063|NCT01319500|E1|Reported Event|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
821773|NCT01320683|O1|Outcome|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
821774|NCT01320683|E1|Reported Event|Treatment (Combination Chemotherapy and Radioimmunotherapy)|FOLFOX* + BEVACIZUMAB CHEMOTHERAPY: Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 12 courses in the absence of disease progression or unacceptable toxicity. RIT: Within 4-12 weeks after completion of post-hepatic resection therapy chemotherapy, patients receive yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A IV over 25 minutes. Treatment repeats every 6-10 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. NOTE:*Patients previously failing oxaliplatin regimen receive FOLIFIRI chemotherapy comprising irinotecan hydrochloride IV over 90 minutes, leucovorin calcium over 2 hours, fluorouracil IV continuously over 46-48 hours, and bevacizumab IV over 30-90 minutes. Treatment repeats for up to 6 courses in the absence of disease progression or unacceptable toxicity.
821775|NCT01320553|B5|Baseline|Total|Total of all reporting groups
821776|NCT01320553|B4|Baseline|Placebo|"Placebo eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
821777|NCT01320553|B3|Baseline|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
821778|NCT01320553|B2|Baseline|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
821779|NCT01320553|B1|Baseline|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
821780|NCT01320553|P4|Participant Flow|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
821781|NCT01320553|P3|Participant Flow|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
821782|NCT01320553|P2|Participant Flow|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
821783|NCT01320553|P1|Participant Flow|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
821784|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
821785|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
821786|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
821787|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
821788|NCT01320553|O4|Outcome|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
821789|NCT01320553|O3|Outcome|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
821790|NCT01320553|O2|Outcome|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
821791|NCT01320553|O1|Outcome|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
821792|NCT01320553|E4|Reported Event|Vehicle|"Vehicle eye drops (solution)will be administered in both eyes at 3 occasions~Placebo: Placebo eye drops (solution)will be administered in both eyes at 3 occasions"
821793|NCT01320553|E3|Reported Event|1334 H-0.45%|"1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions~1334 H-0.45%: 1334H 0.45% eye drops (solution)will be administered in both eyes at 3 occasions"
821794|NCT01320553|E2|Reported Event|1334 H-0.3%|"1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions~1334 H-0.3%: 1334H 0.3% eye drops (solution) will be administered in both eyes at 3 occasions"
821795|NCT01320553|E1|Reported Event|1334 H 0.15%|"1334H 0.15% eye drops will be administered in both eyes at 3 occasions~1334 H 0.15%: 1334H 0.15% eye drops (solution) will be administered in both eyes at 3 occasions"
821796|NCT01320293|B1|Baseline|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
821797|NCT01320293|P1|Participant Flow|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
821798|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
821799|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
821800|NCT01320293|O1|Outcome|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
821801|NCT01320293|E1|Reported Event|Adalimumab|"active~Adalimumab: 40mg subcutaneously, every other week for 6 months"
821805|NCT01320202|P2|Participant Flow|Standard Dialysate|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821806|NCT01320202|P1|Participant Flow|Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821807|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821808|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821809|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821810|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821811|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821812|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821813|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821814|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821815|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821816|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821817|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821818|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821819|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821820|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821821|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821822|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821823|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821824|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821825|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821826|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821827|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821828|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks in Stage 2."
821829|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821871|NCT01319877|P1|Participant Flow|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821830|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821831|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821832|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821833|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821834|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821835|NCT01320202|O2|Outcome|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks."
821836|NCT01320202|O1|Outcome|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks."
821837|NCT01320202|E3|Reported Event|Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3)."
821838|NCT01320202|E2|Reported Event|Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate|"11 micrograms (µg) of iron / deciliter (dL) of dialysate.~Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
821839|NCT01320202|E1|Reported Event|Stage 2 Placebo (Standard Dialysate)|"0 micrograms (µg) of iron / deciliter (dL) of dialysate.~Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks."
821840|NCT01320137|B3|Baseline|Total|Total of all reporting groups
821841|NCT01320137|B2|Baseline|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
821842|NCT01320137|B1|Baseline|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
821843|NCT01320137|P2|Participant Flow|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
821844|NCT01320137|P1|Participant Flow|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
821845|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
821846|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
821847|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
821848|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
821849|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
821850|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
821851|NCT01320137|O2|Outcome|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
821852|NCT01320137|O1|Outcome|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
821853|NCT01320137|E2|Reported Event|Control Group|Subjects with ages ranging from 18-45 years and inclusive, with no known allergies.
821854|NCT01320137|E1|Reported Event|Allergy Group|Subjects with ages ranging from 18-45 years and inclusive, presenting symptomatic allergy to birch pollen.
821855|NCT01320072|B3|Baseline|Total|Total of all reporting groups
821856|NCT01320072|B2|Baseline|Aspirin-tolerant Asthmatics|aspirin-tolerant patients with asthma
821857|NCT01320072|B1|Baseline|Aspirin-sensitive Asthmatics|patients with aspirin exacerbated respiratory disease
821858|NCT01320072|P2|Participant Flow|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
821859|NCT01320072|P1|Participant Flow|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
821860|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Asthma patients with aspirin exacerbated respiratory disease
821861|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
821862|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
821863|NCT01320072|O2|Outcome|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
821864|NCT01320072|O1|Outcome|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
821865|NCT01320072|E2|Reported Event|Aspirin-tolerant Asthmatics|Aspirin tolerant asthma patients, N=13
821866|NCT01320072|E1|Reported Event|Aspirin-sensitive Asthmatics|Patients with aspirin exacerbated respiratory disease, N=16
821867|NCT01319877|B3|Baseline|Total|Total of all reporting groups
821868|NCT01319877|B2|Baseline|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821869|NCT01319877|B1|Baseline|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821870|NCT01319877|P2|Participant Flow|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821874|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821875|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821876|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821877|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821878|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821879|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821880|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821881|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821882|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821883|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821884|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821885|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821886|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821887|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821888|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821889|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821890|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821891|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821892|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821893|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821894|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821895|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821896|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821897|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821898|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821899|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821900|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821901|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821902|NCT01319877|O2|Outcome|Second Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a second line therapy.
821903|NCT01319877|O1|Outcome|First Line Treatment|Participants received bevacizumab in combination with 5-FU based chemotherapy as a first line therapy.
821904|NCT01319877|E1|Reported Event|First and Second Line Treatment|The participants from the first line and second line treatments were combined for the adverse event analysis.
821905|NCT01319851|B1|Baseline|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821906|NCT01319851|P1|Participant Flow|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821907|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821908|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821909|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821910|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821944|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821945|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821911|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821912|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821913|NCT01319851|O1|Outcome|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821914|NCT01319851|E1|Reported Event|Alefacept|Pediatric subjects with non-malignant diseases (NMD) received pre-conditioning with alefacept 0.5 mg/kg/dose i.v. with the first dose split on days -40 and -39 and the remaining doses given on days -33, -26, -19, and -12 (e.g. weekly for 5 doses).
821915|NCT01319812|B3|Baseline|Total|Total of all reporting groups
821916|NCT01319812|B2|Baseline|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
821917|NCT01319812|B1|Baseline|Astron Stent Group|Subjects implanted with an Astron stent.
821918|NCT01319812|P2|Participant Flow|Pulsar Stent Group|Subjects implanted with an Astron Pulsar or Pulsar-18 stent.
821919|NCT01319812|P1|Participant Flow|Astron Stent Group|Subjects implanted with an Astron stent.
821920|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
821921|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
821922|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
821923|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
821924|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
821925|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
821926|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
821927|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
821928|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
821929|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
821930|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
821931|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
821932|NCT01319812|O2|Outcome|Pulsar Stent Group - Long Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 141 mm and 190 mm.
821933|NCT01319812|O1|Outcome|Pulsar Stent Group - Standard Lesion Length|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions with a lesion length between 20 mm and 140 mm.
821934|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821935|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821936|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821937|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821938|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821939|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821940|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821941|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821942|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821943|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
822062|NCT01319500|E2|Reported Event|Other OCs|"Users of OCs except Yasmin (Other OCs)"
821946|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821947|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821948|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821949|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821950|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821951|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821952|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821953|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821954|NCT01319812|O4|Outcome|Pulsar Stent Group - Non-occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821955|NCT01319812|O3|Outcome|Pulsar Stent Group - Occlusive Lesion|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821956|NCT01319812|O2|Outcome|Astron Stent Group - Non-occlusive|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was non-occlusive (70% to 99% stenosis).
821957|NCT01319812|O1|Outcome|Astron Stent Group - Occlusive Lesion|Participants indicated for stenting in iliac atherosclerotic lesions where the target lesion was occlusive (100% stenosis).
821958|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821959|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821960|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821961|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821962|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821963|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821964|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821965|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821966|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821967|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821968|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821969|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821970|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821971|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821972|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821973|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821974|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821975|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821976|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821977|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821978|NCT01319812|O2|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821979|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821980|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821981|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821982|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821983|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821984|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821985|NCT01319812|O1|Outcome|Astron Stent Group|Participants indicated for stenting in iliac atherosclerotic lesions.
821986|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821987|NCT01319812|O1|Outcome|Pulsar Stent Group|Participants indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821988|NCT01319812|E2|Reported Event|Pulsar Stent Group|Subjects indicated for stenting in superficial femoral or proximal popliteal atherosclerotic lesions.
821989|NCT01319812|E1|Reported Event|Astron Stent Group|Subjects indicated for stenting in iliac atherosclerotic lesions.
821990|NCT01319799|B1|Baseline|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
821991|NCT01319799|P1|Participant Flow|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
821992|NCT01319799|O1|Outcome|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
821993|NCT01319799|O1|Outcome|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
821994|NCT01319799|E1|Reported Event|Surgical Aortic Valve Replacement|Open heart surgery : TCD count of microembolic signals during surgical aortic valve replacement
821995|NCT01319773|B6|Baseline|Total|Total of all reporting groups
821996|NCT01319773|B5|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
821997|NCT01319773|B4|Baseline|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
821998|NCT01319773|B3|Baseline|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
821999|NCT01319773|B2|Baseline|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
822000|NCT01319773|B1|Baseline|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
822001|NCT01319773|P5|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
822002|NCT01319773|P4|Participant Flow|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
822003|NCT01319773|P3|Participant Flow|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
822004|NCT01319773|P2|Participant Flow|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
822005|NCT01319773|P1|Participant Flow|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
822006|NCT01319773|O3|Outcome|Cyclosporine 0.05%|
822007|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
822008|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
822009|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
822010|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
822011|NCT01319773|O2|Outcome|Cyclosporine Formulation B|
822012|NCT01319773|O1|Outcome|Cyclosporine Formulation A|
822013|NCT01319773|E5|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine Formulation B|PEP: cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion Formulation B
822014|NCT01319773|E4|Reported Event|PEP: Cyclosporine Formulation B and Cyclosporine 0.05%|PEP: cyclosporine ophthalmic emulsion Formulation B and cyclosporine ophthalmic emulsion 0.05%
822015|NCT01319773|E3|Reported Event|PEP: Cyclosporine Formulation A and Cyclosporine 0.05%|Paired-Eye Phase (PEP): cyclosporine ophthalmic emulsion Formulation A and cyclosporine ophthalmic emulsion 0.05%
822016|NCT01319773|E2|Reported Event|PGP: Cyclosporine Formulation B|PGP: cyclosporine ophthalmic emulsion Formulation B
822017|NCT01319773|E1|Reported Event|PGP: Cyclosporine Formulation A|Parallel-Group Phase (PGP): cyclosporine ophthalmic emulsion Formulation A
822018|NCT01319721|B3|Baseline|Total|Total of all reporting groups
822019|NCT01319721|B2|Baseline|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822020|NCT01319721|B1|Baseline|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822021|NCT01319721|P2|Participant Flow|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822022|NCT01319721|P1|Participant Flow|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822023|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822024|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822025|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822026|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822027|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822028|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822065|NCT01319422|B2|Baseline|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822029|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822030|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822031|NCT01319721|O2|Outcome|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822032|NCT01319721|O1|Outcome|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822033|NCT01319721|E2|Reported Event|Group AMG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then an amniotic membrane graft for repairing the conjunctival defect.
822034|NCT01319721|E1|Reported Event|Group LCAG|After excision of recurrent pterygium, intraoperative 0.2 mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically onto the exposed surgical area and then limbal conjunctival autograft for repairing the conjunctival defect.
822035|NCT01319617|B1|Baseline|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
822036|NCT01319617|P1|Participant Flow|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center."
822037|NCT01319617|O1|Outcome|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
822038|NCT01319617|E1|Reported Event|SENSIMED Triggerfish|"SENSIMED Triggerfish is a device containing a soft silicone contact lens sensor detecting ocular dimensional changes related to IOP through an integrated strain gauge. The device energy and data transfer between the contact lens sensor and the external recording and data storage unit is done using telemetry.~All study subjects received SENSIMED Triggerfish on one eye for 24 hours at two occasions in ambulatory mode, without restriction of activities apart from those contraindicated by the device instructions for use. The device was installed and removed by the study staff during visits to the study center"
822039|NCT01319552|B1|Baseline|Transfusion|"Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions~1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions Old transfusion: 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions"
822040|NCT01319552|P1|Participant Flow|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
822041|NCT01319552|O2|Outcome|Old Transfusion|Old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
822042|NCT01319552|O1|Outcome|Fresh Transfusion|Fresh transfusion: 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
822043|NCT01319552|E1|Reported Event|Transfusion|Fresh transfusion : 1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions followed by old transfusion : 1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
822044|NCT01319500|B3|Baseline|Total|Total of all reporting groups
822045|NCT01319500|B2|Baseline|Other OCs|"Users of OCs except Yasmin (Other OCs)"
822046|NCT01319500|B1|Baseline|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
822047|NCT01319500|P2|Participant Flow|Other OCs|"Users of oral contraceptives (OCs) except Yasmin (Other OCs)"
822048|NCT01319500|P1|Participant Flow|Yasmin|"Users of the drospirenone/ethinylestradiol (DRSP/EE) containing OC Yasmin"
822049|NCT01319500|O5|Outcome|Total|All gynecologists (private and public) and dermatologists
822050|NCT01319500|O4|Outcome|Dermatologists|All dermatologists
822051|NCT01319500|O3|Outcome|Gynecologists (Public Practice Only)|Gynecologists in public practice only
822052|NCT01319500|O2|Outcome|Gynecologists (Private Practice Only)|Gynecologists in private practice only
822053|NCT01319500|O1|Outcome|Gynecologists (All)|All gynecologists (private and public)
822054|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
822055|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
822056|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
822057|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
822058|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
822059|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
822060|NCT01319500|O2|Outcome|Other OCs|"Users of OCs except Yasmin (Other OCs)"
822061|NCT01319500|O1|Outcome|Yasmin|"Users of the DRSP/EE containing OC Yasmin"
822066|NCT01319422|B1|Baseline|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822067|NCT01319422|P2|Participant Flow|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822068|NCT01319422|P1|Participant Flow|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822069|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822070|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822071|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822072|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822073|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822074|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822075|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822076|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822077|NCT01319422|O2|Outcome|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822078|NCT01319422|O1|Outcome|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822079|NCT01319422|E2|Reported Event|Pomalidomide 2 mg/d on 28 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822080|NCT01319422|E1|Reported Event|Pomalidomide 4 mg/d on 21 Days/28 Day Cycle|Pomalidomide: Comparison of different dosages and schedules of drug
822081|NCT01319396|B1|Baseline|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
822082|NCT01319396|P1|Participant Flow|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
822083|NCT01319396|O1|Outcome|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
822084|NCT01319396|E1|Reported Event|All Participants|All participants had the difference in indicated breathing rate measured. The 2 devices were the BM07 (device under test) and the Somnoscreen (reference device)
822085|NCT01319318|B1|Baseline|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
822086|NCT01319318|P1|Participant Flow|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
822087|NCT01319318|O1|Outcome|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
822088|NCT01319318|E1|Reported Event|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
822089|NCT01319110|B3|Baseline|Total|Total of all reporting groups
822090|NCT01319110|B2|Baseline|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
822091|NCT01319110|B1|Baseline|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
822092|NCT01319110|P2|Participant Flow|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
822093|NCT01319110|P1|Participant Flow|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
822094|NCT01319110|O2|Outcome|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
822095|NCT01319110|O1|Outcome|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
822096|NCT01319110|E2|Reported Event|Placebo|"Patients will receive 20 ml chocolate Ensure (as a placebo) three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). Placebo will be given through pre-existing NG or OG tube.~Placebo: Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo."
822142|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822097|NCT01319110|E1|Reported Event|CoenzymeQ10|"Patients will receive CoenzymeQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.~Coenzyme Q10: Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff."
822098|NCT01319045|B1|Baseline|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
822099|NCT01319045|P1|Participant Flow|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
822100|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
822101|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
822102|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
822103|NCT01319045|O1|Outcome|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
822104|NCT01319045|E1|Reported Event|Iloprost|"Participants will be administered iloprost at 5 mcg/dose x 6 doses daily for 3 months.~Iloprost: Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months"
822105|NCT01318967|B1|Baseline|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
822106|NCT01318967|P1|Participant Flow|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
822107|NCT01318967|O1|Outcome|MRI After Furosemide|"After the PAH measurement is complete, subjects receive 20 mg furosemide and undergo BOLD MRI to estimate renal blood flow~Furosemide: Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only."
822108|NCT01318967|O1|Outcome|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide.~Renal blood flow is measured by PAH method and by MRI method"
822109|NCT01318967|E1|Reported Event|Furosemide|"With and without furosemide~Furosemide: Renal blood flow is measured before and after the administration of 20 mg of furosemide."
822110|NCT01318876|B1|Baseline|Health Care Workers|HCW who had completed at least 1 survey (n=6269) and not the number of participants enrolled in the study.
822111|NCT01318876|P1|Participant Flow|Health Care Workers|
822112|NCT01318876|O1|Outcome|HCW From All Sites|
822113|NCT01318876|O1|Outcome|HCW From All Sites|
822114|NCT01318876|E1|Reported Event|HCW From All Sites|
822115|NCT01318733|B1|Baseline|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
822116|NCT01318733|P1|Participant Flow|CD07805/47 Gel 0.5%|CD07805/47 Gel 0.5% once daily
822117|NCT01318733|O1|Outcome|CD07805/47 Gel 0.5% QD|
822118|NCT01318733|E1|Reported Event|CD07805/47 Gel 0.5%|
822119|NCT01318694|B5|Baseline|Total|Total of all reporting groups
822120|NCT01318694|B4|Baseline|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822121|NCT01318694|B3|Baseline|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822122|NCT01318694|B2|Baseline|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822123|NCT01318694|B1|Baseline|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822124|NCT01318694|P4|Participant Flow|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822125|NCT01318694|P3|Participant Flow|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg once daily (QD) for 47 weeks
822126|NCT01318694|P2|Participant Flow|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
822127|NCT01318694|P1|Participant Flow|Treatment Arm A|Alisporivir (ALV) 600 mg twice daily (BID) with Peginterferon alfa-2a (PEG) and ribavirin (RBV) for 1 week, followed by an additional 23 or 47 weeks according to response-guided treatment duration (RGT)
822128|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822129|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822130|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822131|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822132|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822133|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822134|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822135|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822136|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822137|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822138|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822139|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822140|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822141|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822143|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822144|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822145|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822146|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822147|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822148|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822149|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822150|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822151|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822152|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822153|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822154|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822155|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822156|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822157|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822158|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822159|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822160|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822161|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822162|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822163|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822164|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822165|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822166|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822167|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822168|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822169|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822170|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822171|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822172|NCT01318694|O4|Outcome|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822173|NCT01318694|O3|Outcome|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822174|NCT01318694|O2|Outcome|Treatment Arm B|Alisporivir (ALV) 400 mg BID with PEG and RBV for 24 or 48 weeks according to RGT
822175|NCT01318694|O1|Outcome|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822176|NCT01318694|E4|Reported Event|Treatment Arm D|ALV Placebo with PEG and RBV for 48 weeks
822177|NCT01318694|E3|Reported Event|Treatment Arm C|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by 600 mg QD for 47 weeks
822178|NCT01318694|E2|Reported Event|Treatment Arm B|Alisporivir (ALV) 400 mg twice daily (BID) with PEG and RBV for 24 or 48 weeks according to response-guided treatment duration (RGT)
822179|NCT01318694|E1|Reported Event|Treatment Arm A|Alisporivir (ALV) 600 mg BID with PEG and RBV for 1 week, followed by an additional 23 or 47 weeks according to RGT
822180|NCT01318538|B3|Baseline|Total|Total of all reporting groups
822181|NCT01318538|B2|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. NOTE: Baseline characteristics reported in Table Below reflect all participants including men assigned to the GDC condition. Analysis of data for study specific aims include only women randomized to WRG (N=52) and GDC (N=48).
822182|NCT01318538|B1|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822183|NCT01318538|P3|Participant Flow|Group Therapist|Therapists who ran and led the group sessions for both the single-gender Women's Recovery Group and mixed-gender Group Drug Counseling.
822184|NCT01318538|P2|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822185|NCT01318538|P1|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822186|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822187|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822188|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822189|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822190|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822191|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822192|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822219|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
822221|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing haemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of haemoglobin.
822193|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822194|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822195|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822196|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Participants in this analysis are the therapists that lead GDC groups. Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822197|NCT01318538|O1|Outcome|Women's Recovery Group|Participants in this analysis are the therapists that lead the WRG groups. The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822198|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822199|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822200|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822201|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822220|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822202|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822203|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822204|NCT01318538|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
822205|NCT01318538|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
822206|NCT01318538|E2|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance dependence; 3) increase patients’ self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
822207|NCT01318538|E1|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
822208|NCT01318512|B1|Baseline|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
822209|NCT01318512|P1|Participant Flow|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with methoxy polyethylene glycol-epoetin beta (MIRCERA) subcutaneously (SC) as per summary of product characteristics (SPC) due to decreased levels of hemoglobin.
822210|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822211|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822212|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822213|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822214|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822215|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822216|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822217|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822218|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822648|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822222|NCT01318512|O1|Outcome|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822223|NCT01318512|E1|Reported Event|Chronic Kidney Disease (CKD)|Participants with CKD, not undergoing hemodialysis in clinical practice setting and started treatment with MIRCERA subcutaneously due to decreased levels of hemoglobin.
822224|NCT01318499|B4|Baseline|Total|Total of all reporting groups
822225|NCT01318499|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822226|NCT01318499|B2|Baseline|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822227|NCT01318499|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822228|NCT01318499|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822229|NCT01318499|P2|Participant Flow|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822230|NCT01318499|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822231|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822232|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822233|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822234|NCT01318499|O3|Outcome|Nepafenac 0.3% Vehicle|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822235|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822236|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822237|NCT01318499|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822238|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822239|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822240|NCT01318499|O2|Outcome|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822241|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822242|NCT01318499|O2|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822243|NCT01318499|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822244|NCT01318499|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822323|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822326|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822245|NCT01318499|E2|Reported Event|Nepafenac 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822246|NCT01318499|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional drop was administered between 30-120 minutes prior to surgery.
822247|NCT01318408|B1|Baseline|Open Label|All participants received study drug.
822248|NCT01318408|P1|Participant Flow|Open Label|All participants received study drug.
822249|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
822250|NCT01318408|O1|Outcome|Open Label|All participants received study drug.
822251|NCT01318408|E1|Reported Event|Open Label|All participants received study drug. Four withdrew due to adverse events; related to fatigue.
822252|NCT01318382|B1|Baseline|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
822253|NCT01318382|P1|Participant Flow|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from neuromuscular blockade (NMB) monitored by a TOF-Watch SX®.
822254|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
822255|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
822256|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of PACU arrival.
822257|NCT01318382|O1|Outcome|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker, had the extent of their recovery from NMB monitored by a TOF-Watch SX® and had an evaluable TOF Ratio at time of tracheal extubation.
822258|NCT01318382|E1|Reported Event|TOF-Watch SX®|All enrolled participants who had undergone elective open or laparoscopic abdominal surgery, received general anesthesia, received at least one dose of non-depolarizing neuromuscular blocker and had the extent of their recovery from NMB monitored by a TOF-Watch SX®.
822259|NCT01318278|B4|Baseline|Total|Total of all reporting groups
822260|NCT01318278|B3|Baseline|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822261|NCT01318278|B2|Baseline|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822262|NCT01318278|B1|Baseline|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822263|NCT01318278|P3|Participant Flow|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822264|NCT01318278|P2|Participant Flow|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822265|NCT01318278|P1|Participant Flow|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822266|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822267|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822268|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822269|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822270|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822271|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822272|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822325|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822273|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822274|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822275|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822276|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822277|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822278|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822279|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822280|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822281|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822282|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822283|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822284|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822285|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822286|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822287|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822288|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822289|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822290|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822291|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822292|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822293|NCT01318278|O3|Outcome|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822294|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822295|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822296|NCT01318278|O3|Outcome|Comparison Group|Infants not diagnosed with hypotension in first 24 hours
822297|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822298|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822324|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822299|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822300|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822301|NCT01318278|O2|Outcome|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822302|NCT01318278|O1|Outcome|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822303|NCT01318278|E3|Reported Event|Comparison Arm|Infants who did not require vasopressor support for hypotension during the first 24 hours of life
822304|NCT01318278|E2|Reported Event|Vasopressin Treatment|"Arginine Vasopressin treatment beginning at 0.01 units/kg/hr and titrated up by 0.01 units/kg/hr to effect up to a maximum of 0.04 units/kg/hr~Arginine Vasopressin: vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy"
822305|NCT01318278|E1|Reported Event|Dopamine Treatment|"Dopamine treatment beginning at 5 mcg/kg/min and titrated by 5 mcg/kg/min to effect up to maximum of 20 mcg/kg/min~Dopamine: dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy"
822306|NCT01318135|B5|Baseline|Total|Total of all reporting groups
822307|NCT01318135|B4|Baseline|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822308|NCT01318135|B3|Baseline|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822309|NCT01318135|B2|Baseline|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822310|NCT01318135|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822311|NCT01318135|P8|Participant Flow|Metformin Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
822312|NCT01318135|P7|Participant Flow|Metformin Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the metformin 500 mg or 750 mg dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
822313|NCT01318135|P6|Participant Flow|CCT/006 - 25 mg Dose Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
822314|NCT01318135|P5|Participant Flow|CCT/006 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-006 (NCT01318109) core phase 2/3 metformin add-on study."
822315|NCT01318135|P4|Participant Flow|Glimepiride Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
822316|NCT01318135|P3|Participant Flow|Glimepiride Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the glimepiride 1, 2, 3 or 4 mg dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
822317|NCT01318135|P2|Participant Flow|CCT/005 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
822318|NCT01318135|P1|Participant Flow|CCT/005 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-005 (NCT01318083) core phase 2/3 glimepiride add-on study."
822319|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822320|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822321|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822322|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822327|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822328|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822329|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822330|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822331|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822332|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822333|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822334|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822335|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822336|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822337|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822338|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822339|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822340|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822341|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822342|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822343|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822344|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822345|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822346|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822347|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822348|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822349|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822350|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822351|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822352|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822353|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822354|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822706|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
822413|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822355|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822356|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822357|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822358|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822359|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822360|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822361|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822362|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822363|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822364|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822365|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822366|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822367|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822368|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822369|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822370|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822371|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822372|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822373|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822374|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822375|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822376|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822377|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822378|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822379|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822380|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822381|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822382|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822383|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822384|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822385|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822386|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822387|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822388|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822389|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822390|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822391|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822392|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822393|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822394|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822395|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822396|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822397|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822398|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822399|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822400|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822401|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822402|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822403|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822404|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822405|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822406|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822407|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822408|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822409|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822410|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822411|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822412|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822414|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822415|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822416|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822417|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822418|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822419|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822420|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822421|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822422|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822423|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822424|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822425|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822426|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822427|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822428|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822429|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822430|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822431|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822432|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822433|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822434|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822435|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822436|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822437|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822438|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822439|NCT01318135|O4|Outcome|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822440|NCT01318135|O3|Outcome|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822441|NCT01318135|O2|Outcome|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822707|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
822442|NCT01318135|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822443|NCT01318135|E4|Reported Event|Alogliptin 25 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822444|NCT01318135|E3|Reported Event|Alogliptin 12.5 mg QD and Metformin 500 mg BID or 750 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
822445|NCT01318135|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride 1 - 6 mg QD or BID|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822446|NCT01318135|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride 1- 6 mg QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
822447|NCT01318122|B3|Baseline|Total|Total of all reporting groups
822448|NCT01318122|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822449|NCT01318122|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822450|NCT01318122|P4|Participant Flow|Pioglitazone Monotherapy Group* → 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
822451|NCT01318122|P3|Participant Flow|Pioglitazone Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the pioglitazone 15 mg or 30 mg dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
822452|NCT01318122|P2|Participant Flow|CCT/004 - 25 mg Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
822453|NCT01318122|P1|Participant Flow|CCT/004 - 12.5 mg Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
822454|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822455|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822456|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822457|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822458|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822459|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822460|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822461|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822462|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822463|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822464|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822465|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822466|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822467|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822468|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822469|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822470|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822471|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822472|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822473|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822474|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822475|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822476|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822477|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822478|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822479|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822480|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822481|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822482|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822483|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822484|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822485|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822486|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822487|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822488|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822489|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822490|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822491|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822492|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822493|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822494|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822495|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822496|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822497|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822498|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822499|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822500|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822501|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822502|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822503|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822504|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822505|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822506|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822507|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822508|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822509|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822510|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822511|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822512|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822513|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822514|NCT01318122|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822515|NCT01318122|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822516|NCT01318122|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|"Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.~*for participants from the 25 mg combination dosing ARM of the SYR-322/CCT-004 (NCT01318070) core phase 2/3 pioglitazone add-on study."
822517|NCT01318122|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
822518|NCT01318109|B4|Baseline|Total|Total of all reporting groups
822519|NCT01318109|B3|Baseline|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822520|NCT01318109|B2|Baseline|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822521|NCT01318109|B1|Baseline|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822522|NCT01318109|P3|Participant Flow|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822523|NCT01318109|P2|Participant Flow|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822524|NCT01318109|P1|Participant Flow|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822525|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822526|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822527|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822528|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822529|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822530|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822531|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822532|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822533|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822534|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822535|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822536|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822537|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822538|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822539|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822783|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
822540|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822541|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822542|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822543|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822544|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822545|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822546|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822547|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822548|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822549|NCT01318109|O3|Outcome|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822550|NCT01318109|O2|Outcome|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822551|NCT01318109|O1|Outcome|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822552|NCT01318109|E3|Reported Event|Metformin 500mg BID or 750mg TID|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822553|NCT01318109|E2|Reported Event|Alogliptin 25mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822554|NCT01318109|E1|Reported Event|Alogliptin 12.5 mg QD and Metformin 500mg BID or 750mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
822555|NCT01318083|B4|Baseline|Total|Total of all reporting groups
822556|NCT01318083|B3|Baseline|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822557|NCT01318083|B2|Baseline|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822558|NCT01318083|B1|Baseline|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822559|NCT01318083|P3|Participant Flow|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822560|NCT01318083|P2|Participant Flow|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822561|NCT01318083|P1|Participant Flow|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822562|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822563|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822564|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822565|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822566|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822567|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822568|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822569|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822570|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822571|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822572|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822646|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822573|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822574|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822575|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822576|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822577|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822578|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822579|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822580|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822581|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822582|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822583|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822584|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822585|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822586|NCT01318083|O3|Outcome|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822587|NCT01318083|O2|Outcome|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822588|NCT01318083|O1|Outcome|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822589|NCT01318083|E3|Reported Event|Glimepiride 1, 2, 3 or 4 mg QD or BID|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
822590|NCT01318083|E2|Reported Event|Alogliptin 25 mg QD and Glimepiride QD or BID|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822591|NCT01318083|E1|Reported Event|Alogliptin 12.5 mg QD and Glimepiride QD or BID|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
822592|NCT01318070|B4|Baseline|Total|Total of all reporting groups
822593|NCT01318070|B3|Baseline|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822594|NCT01318070|B2|Baseline|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822595|NCT01318070|B1|Baseline|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822596|NCT01318070|P3|Participant Flow|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822597|NCT01318070|P2|Participant Flow|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822598|NCT01318070|P1|Participant Flow|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822599|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822600|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822601|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822602|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822603|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822604|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822605|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822606|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822607|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822608|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822647|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822609|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822610|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822611|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822612|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822613|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822614|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822615|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822616|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822617|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822618|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822619|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822620|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822621|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822622|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822623|NCT01318070|O3|Outcome|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822624|NCT01318070|O2|Outcome|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822625|NCT01318070|O1|Outcome|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822626|NCT01318070|E3|Reported Event|Pioglitazone 15 mg or 30 mg QD|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822627|NCT01318070|E2|Reported Event|Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822628|NCT01318070|E1|Reported Event|Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
822638|NCT01317797|B4|Baseline|Total|Total of all reporting groups
822639|NCT01317797|B3|Baseline|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822640|NCT01317797|B2|Baseline|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822641|NCT01317797|B1|Baseline|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822642|NCT01317797|P3|Participant Flow|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822643|NCT01317797|P2|Participant Flow|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822644|NCT01317797|P1|Participant Flow|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822645|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822649|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822650|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822651|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822652|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822653|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822654|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822655|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822656|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822657|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822658|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822659|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822660|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822661|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822662|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822663|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822664|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822665|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822666|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822667|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822668|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822669|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822670|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822671|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822672|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822673|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822674|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822675|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822676|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822677|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822678|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822679|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822680|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822681|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822682|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822683|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822684|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822685|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822686|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822687|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822688|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822689|NCT01317797|O3|Outcome|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822690|NCT01317797|O2|Outcome|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822691|NCT01317797|O1|Outcome|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822692|NCT01317797|E3|Reported Event|Placebo|Namilumab-matching placebo, SC injection, on Days 1, 15 and 29.
822693|NCT01317797|E2|Reported Event|Namilumab 300 mg|Namilumab (MT203) 300 mg (high dose), SC injection, on Days 1, 15 and 29.
822694|NCT01317797|E1|Reported Event|Namilumab 150 mg|Namilumab (MT203) 150 mg (low dose), subcutaneous (SC) injection, on Days 1, 15 and 29.
822695|NCT01317667|B4|Baseline|Total|Total of all reporting groups
822696|NCT01317667|B3|Baseline|Group 3|RVEc vaccine 100 μg/dose x 1 dose
822697|NCT01317667|B2|Baseline|Group 2|RVEc vaccine 50 μg/dose x 3 doses
822698|NCT01317667|B1|Baseline|Group 1|RVEc vaccine 20 μg/dose x 3 doses
822699|NCT01317667|P3|Participant Flow|Group 3|RVEc vaccine 100 μg/dose x 1 dose
822700|NCT01317667|P2|Participant Flow|Group 2|RVEc vaccine 50 μg/dose x 3 doses
822701|NCT01317667|P1|Participant Flow|Group 1|RVEc vaccine 20 μg/dose x 3 doses
822702|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
822703|NCT01317667|O2|Outcome|Group 2|RVEc vaccine 50 μg/dose x 3 doses
822704|NCT01317667|O1|Outcome|Group 1|RVEc vaccine 20 μg/dose x 3 doses
822705|NCT01317667|O3|Outcome|Group 3|RVEc vaccine 100 μg/dose x 1 dose
822708|NCT01317667|E3|Reported Event|Group 3|RVEc vaccine 100 μg/dose x 1 dose
822709|NCT01317667|E2|Reported Event|Group 2|RVEc vaccine 50 μg/dose x 3 doses
822710|NCT01317667|E1|Reported Event|Group 1|RVEc vaccine 20 μg/dose x 3 doses
822711|NCT01317641|B10|Baseline|Total|Total of all reporting groups
822712|NCT01317641|B9|Baseline|Phase 2 (1400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
822713|NCT01317641|B8|Baseline|Phase 2 (400mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously.
822714|NCT01317641|B7|Baseline|Phase 2 (200mg/Day ODM-201)|Dose expansion. Participants received twice daily of 200 mg of oral ODM-201 continuously
822715|NCT01317641|B6|Baseline|Phase 1, 1800mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
822716|NCT01317641|B5|Baseline|Phase 1, 1400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
822717|NCT01317641|B4|Baseline|Phase 1, 1000mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
822718|NCT01317641|B3|Baseline|Phase 1, 600mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
822719|NCT01317641|B2|Baseline|Phase 1, 400mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
822720|NCT01317641|B1|Baseline|Phase 1, 200mg/Day ODM-201|Dose escalation. Participants received twice daily of oral ODM-201 continuously.
822721|NCT01317641|P9|Participant Flow|Phase 2: ODM-201 1400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
822722|NCT01317641|P8|Participant Flow|Phase 2: ODM-201 400mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
822723|NCT01317641|P7|Participant Flow|Phase 2: ODM-201 200mg/Day|Chemotherapy-naïve and CYP17 inhibitor-naïve, Post-chemotherapy and CYP17 inhibitor-naïve, Post-CYP17 inhibitor
822724|NCT01317641|P6|Participant Flow|Phase 1: ODM-201 1800 mg/Day|Dose escalation
822725|NCT01317641|P5|Participant Flow|Phase 1: ODM-201 1400 mg/Day|Dose escalation
822726|NCT01317641|P4|Participant Flow|Phase 1: ODM-201 1000 mg/Day|Dose escalation
822727|NCT01317641|P3|Participant Flow|Phase 1: ODM-201 600 mg/Day|Dose escalation
822728|NCT01317641|P2|Participant Flow|Phase 1: ODM-201 400 mg/Day|Dose escalation
822729|NCT01317641|P1|Participant Flow|Phase 1: ODM-201 200 mg/Day|Dose escalation
822730|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
822731|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
822732|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
822733|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
822734|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
822735|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
822736|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
822737|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
822738|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
822739|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
822740|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
822741|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
822742|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
822743|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
822744|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
822745|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
822746|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
822747|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
822748|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
822749|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
822750|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
822751|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
822752|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
822753|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
822754|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
822755|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
822756|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
822757|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
822758|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
822759|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
822760|NCT01317641|O6|Outcome|1800 mg/Day ODM-201|Phase 1
822761|NCT01317641|O5|Outcome|1400 mg/Day ODM-201|Phase 1
822762|NCT01317641|O4|Outcome|1000 mg/Day ODM-201|Phase 1
822763|NCT01317641|O3|Outcome|600 mg/Day ODM-201|Phase 1
822764|NCT01317641|O2|Outcome|400 mg/Day ODM-201|Phase 1
822765|NCT01317641|O1|Outcome|200 mg/Day ODM-201|Phase 1
822766|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822767|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
822768|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822769|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822770|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822771|NCT01317641|O4|Outcome|1000mg/Day ODM-201|Phase 1
822772|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
822773|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822774|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822775|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
822776|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822777|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
822778|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822779|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822780|NCT01317641|O3|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822781|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822782|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822784|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822785|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
822786|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822787|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822788|NCT01317641|O5|Outcome|1800mg/Day ODM-201|Phase 1
822789|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822790|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
822791|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822792|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822793|NCT01317641|O4|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822794|NCT01317641|O3|Outcome|1000mg/Day ODM-201|Phase 1
822795|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822796|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822797|NCT01317641|O6|Outcome|1800mg/Day ODM-201|Phase 1
822798|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822799|NCT01317641|O4|Outcome|1000mg/Day ODM-201|Phase 1
822800|NCT01317641|O3|Outcome|600mg/Day ODM-201|Phase 1
822801|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822802|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822803|NCT01317641|O6|Outcome|1800mg/Day ODM-201|phase 1
822804|NCT01317641|O5|Outcome|1400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822805|NCT01317641|O4|Outcome|1000mg/Day ODM-201|phase 1
822806|NCT01317641|O3|Outcome|600mg/Day ODM-201|phase 1
822807|NCT01317641|O2|Outcome|400mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822808|NCT01317641|O1|Outcome|200mg/Day ODM-201|expanded dose level (phase 1 + phase 2)
822809|NCT01317641|O6|Outcome|Phase 1: ODM-201 1800 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822810|NCT01317641|O5|Outcome|Phase 1: ODM-201 1400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822811|NCT01317641|O4|Outcome|Phase 1: ODM-201 1000 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822812|NCT01317641|O3|Outcome|Phase 1: ODM-201 600 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822813|NCT01317641|O2|Outcome|Phase 1: ODM-201 400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822814|NCT01317641|O1|Outcome|Phase 1: ODM-201 200 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822815|NCT01317641|O6|Outcome|Phase 1: ODM-201 1800 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822816|NCT01317641|O5|Outcome|Phase 1: ODM-201 1400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822817|NCT01317641|O4|Outcome|Phase 1: ODM-201 1000 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822818|NCT01317641|O3|Outcome|Phase 1: ODM-201 600 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822819|NCT01317641|O2|Outcome|Phase 1: ODM-201 400 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822820|NCT01317641|O1|Outcome|Phase 1: ODM-201 200 mg/Day|Participants received twice daily of oral ODM-201 continuously.
822821|NCT01317641|E9|Reported Event|Phase 2, 1400mg/Day ODM-201|Dose expansion
822822|NCT01317641|E8|Reported Event|Phase 2, 400mg/Day ODM-201|Dose expansion
822823|NCT01317641|E7|Reported Event|Phase 2, 200mg/Day ODM-201|Dose expansion
822824|NCT01317641|E6|Reported Event|Phase 1, 1800mg/Day ODM-201|Dose escalation
822825|NCT01317641|E5|Reported Event|Phase 1, 1400mg/Day ODM-201|Dose escalation
822826|NCT01317641|E4|Reported Event|Phase 1, 1000mg/Day ODM-201|Dose escalation
822827|NCT01317641|E3|Reported Event|Phase 1, 600mg/Day ODM-201|Dose escalation
822828|NCT01317641|E2|Reported Event|Phase 1, 400mg/Day ODM-201|Dose escalation
822829|NCT01317641|E1|Reported Event|Phase 1, 200mg/Day ODM-201|Dose escalation
822830|NCT01317615|B1|Baseline|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822831|NCT01317615|P1|Participant Flow|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822832|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822833|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822834|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822835|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822836|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822837|NCT01317615|O1|Outcome|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822838|NCT01317615|E1|Reported Event|RAD001 Plus Paclitaxel/Carboplatin|Participants received RAD001 5 mg orally once daily in combination with carboplatin and paclitaxel for a maximum 4 cycles or until discontinuation.
822839|NCT01317160|B3|Baseline|Total|Total of all reporting groups
822865|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822866|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822840|NCT01317160|B2|Baseline|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
822841|NCT01317160|B1|Baseline|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
822842|NCT01317160|P2|Participant Flow|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
822843|NCT01317160|P1|Participant Flow|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
822844|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
822845|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
822877|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
822846|NCT01317160|O2|Outcome|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
822847|NCT01317160|O1|Outcome|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
822848|NCT01317160|E2|Reported Event|Intermittent Pneumatic Compression (IPC)|"Two weeks of calf IPC by Aircast® VenaFlow® Elite System during immobilization in an orthosis Aicast® XP Walker.~Intermittent pneumatic compression (IPC): 6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute."
822849|NCT01317160|E1|Reported Event|Routine Care: Plaster Cast Treatment|Two weeks of postoperative conventional lower limb plaster cast immobilization in 30 degrees of plantarflexion
822850|NCT01317004|B3|Baseline|Total|Total of all reporting groups
822851|NCT01317004|B2|Baseline|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822852|NCT01317004|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822853|NCT01317004|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822854|NCT01317004|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822855|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822856|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822857|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822858|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822859|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822860|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822861|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822862|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822863|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822864|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
823012|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
822867|NCT01317004|O2|Outcome|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822868|NCT01317004|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822869|NCT01317004|E2|Reported Event|Multiple Sclerosis Disease Modifying Treatment (MS DMT)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
822870|NCT01317004|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
822871|NCT01316926|B1|Baseline|Participants Receiving Both Test and Reference Product|Participants receiving either test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2 or reference product in period 1 and test product in period 2
822872|NCT01316926|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in Period 1; followed by test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 2
822873|NCT01316926|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: paroxetine hydrochloride tablet with controlled release (Paxil CR) 25 milligrams (mg), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in Period 1; followed by reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
822874|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
822875|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
822876|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in both periods
823184|NCT01316315|O2|Outcome|Placebo|Non-Active
822878|NCT01316926|O2|Outcome|Reference Product|Reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra in both periods
822879|NCT01316926|O1|Outcome|Test Product|Test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada in both periods
822880|NCT01316926|E2|Reported Event|Period 2|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 2
822881|NCT01316926|E1|Reported Event|Period 1|Participants receiving test product: Paxil CR 25 mg, once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada or reference product: Paxil CR 25 mg, once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico in Period 1
822882|NCT01316913|B5|Baseline|Total|Total of all reporting groups
822883|NCT01316913|B4|Baseline|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
822884|NCT01316913|B3|Baseline|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822885|NCT01316913|B2|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822886|NCT01316913|B1|Baseline|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822887|NCT01316913|P4|Participant Flow|TIO18 µg QD|Participants received tiotropium bromide (TIO) 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
822888|NCT01316913|P3|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822889|NCT01316913|P2|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822890|NCT01316913|P1|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI) and placebo QD via a HandiHaler in the morning for 24 weeks.
822891|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
822892|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822893|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822894|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822895|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
822896|NCT01316913|O3|Outcome|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822897|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822898|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822899|NCT01316913|O4|Outcome|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
822900|NCT01316913|O3|Outcome|UMEC/VI 125/25 QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822901|NCT01316913|O2|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822902|NCT01316913|O1|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822903|NCT01316913|E4|Reported Event|TIO18 µg QD|Participants received TIO 18 µg QD via a HandiHaler and placebo QD via a DPI in the morning for 24 weeks.
822904|NCT01316913|E3|Reported Event|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822905|NCT01316913|E2|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822906|NCT01316913|E1|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg QD via a DPI and placebo QD via a HandiHaler in the morning for 24 weeks.
822907|NCT01316900|B5|Baseline|Total|Total of all reporting groups
822908|NCT01316900|B4|Baseline|Tiotropium 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
822909|NCT01316900|B3|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822910|NCT01316900|B2|Baseline|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822911|NCT01316900|B1|Baseline|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
822912|NCT01316900|P4|Participant Flow|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
822913|NCT01316900|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822914|NCT01316900|P2|Participant Flow|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822915|NCT01316900|P1|Participant Flow|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
822916|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
822917|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822918|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822919|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
822920|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
822921|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822922|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822923|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
822924|NCT01316900|O4|Outcome|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
822925|NCT01316900|O3|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822926|NCT01316900|O2|Outcome|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822927|NCT01316900|O1|Outcome|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
822928|NCT01316900|E4|Reported Event|TIO 18 µg|Participants received tiotropium (TIO) 18 µg QD via a HandiHaler. All participants also received placebo QD via a DPI.
822929|NCT01316900|E3|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822930|NCT01316900|E2|Reported Event|UMEC/VI 62.5/25 µg|Participants received umeclidinium bromide (UMEC)/VI 62.5/25 µg QD via a DPI. All participants also received placebo QD via a HandiHaler.
822931|NCT01316900|E1|Reported Event|VI 25 µg|Participants received vilanterol (VI) 25 micrograms (µg) once daily (QD) via a dry powder inhaler (DPI). All participants also received placebo QD via a HandiHaler.
822932|NCT01316887|B4|Baseline|Total|Total of all reporting groups
822933|NCT01316887|B3|Baseline|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822934|NCT01316887|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822935|NCT01316887|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822936|NCT01316887|P3|Participant Flow|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822937|NCT01316887|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822938|NCT01316887|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822939|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822940|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822941|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822942|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
823085|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
822943|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822944|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822945|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822946|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822947|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822948|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822949|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822950|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822951|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822952|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822953|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822954|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822955|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822956|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822957|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822958|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822959|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822960|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822961|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822962|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822963|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822964|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822965|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822966|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822967|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822968|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822969|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822970|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822971|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822972|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822973|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822974|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822975|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822976|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822977|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822978|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822979|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822980|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822981|NCT01316887|O3|Outcome|UMEC/VI 125/25µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822982|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822983|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822984|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822985|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822986|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822987|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822988|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822989|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822990|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822991|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822992|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822993|NCT01316887|O3|Outcome|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822994|NCT01316887|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822995|NCT01316887|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.
822996|NCT01316887|E3|Reported Event|UMEC/VI 125/25 µg|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 125/25 µg QD in the morning via a DPI for 52 weeks.
822997|NCT01316887|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 52 weeks.
822998|NCT01316887|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 52 weeks.ve
822999|NCT01316692|B1|Baseline|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823185|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
823000|NCT01316692|P1|Participant Flow|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823001|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823002|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823003|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823004|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823005|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823006|NCT01316692|O1|Outcome|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823007|NCT01316692|E1|Reported Event|MLN8237|"Patients receive oral Aurora A kinase inhibitor MLN8237 every 12 hours on days 1-7. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~laboratory biomarker identification and analysis: Correlative studies~biopsy: Correlative studies~immunohistochemistry/tissue microarrays: Correlative studies~TdT-mediated dUTP nick end labeling assay: Correlative studies~mass spectrometry: Correlative studies"
823008|NCT01316614|B1|Baseline|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
823009|NCT01316614|P1|Participant Flow|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet. Only the order of the passes were randomized.
823010|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
823011|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
823013|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
823014|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
823015|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
823016|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
823017|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
823018|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
823019|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
823020|NCT01316614|O2|Outcome|Without Stylet|Each participant had half of their passes performed without a stylet.
823021|NCT01316614|O1|Outcome|With Stylet|Each participant had half of their passes performed with a stylet.
823022|NCT01316614|E1|Reported Event|With Stylet & Without Stylet|There will only be one arm in this study. This arm will undergo EUS-guided FNA with the use of a stylet for half of their FNA passes and without a stylet for the other half. Patients will be exposed to an equal number of passes with and without a stylet.
823023|NCT01316575|B3|Baseline|Total|Total of all reporting groups
823024|NCT01316575|B2|Baseline|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
823025|NCT01316575|B1|Baseline|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
823026|NCT01316575|P2|Participant Flow|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
823027|NCT01316575|P1|Participant Flow|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
823028|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
823029|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
823030|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
823031|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
823032|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
823033|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
823034|NCT01316575|O2|Outcome|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
823035|NCT01316575|O1|Outcome|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
823036|NCT01316575|E2|Reported Event|Low Flow Oxygen|
823037|NCT01316575|E1|Reported Event|nCPAP|
823038|NCT01316419|B1|Baseline|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823039|NCT01316419|P1|Participant Flow|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823040|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823041|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823042|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823043|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823044|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823045|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823046|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823047|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823084|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823048|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823049|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823050|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823051|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823052|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823053|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823054|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823186|NCT01316315|O2|Outcome|Placebo|Patients received a single IV administration of 5 mL of placebo on Day 1 in each treatment period and single dose of N6022 on the day 1 of the second period.
823055|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823056|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823057|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823058|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823059|NCT01316419|O1|Outcome|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823060|NCT01316419|E1|Reported Event|Twynsta (Telmisartan and Amlodipine FDC) Tablets|Oral administration of Twynsta (Telmisartan and amlodipine FDC) tablets. The doses of telmisartan are 40 mg and 80 mg combined with either 5 mg or 10 mg of amlodipine. The dose combinations for telmisartan/amlodipine in the study are as follows: 40 mg/5 mg, 40 mg/10 mg and 80 mg/5 mg.
823061|NCT01316380|B4|Baseline|Total|Total of all reporting groups
823062|NCT01316380|B3|Baseline|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823063|NCT01316380|B2|Baseline|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823064|NCT01316380|B1|Baseline|Placebo|Patients treated with matching placebo
823065|NCT01316380|P3|Participant Flow|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823066|NCT01316380|P2|Participant Flow|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823067|NCT01316380|P1|Participant Flow|Placebo|Patients treated with matching placebo
823068|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823069|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823070|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823071|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823072|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823073|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823074|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823075|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823076|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823077|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823078|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823079|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823080|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823081|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823082|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823083|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823086|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823087|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823088|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823089|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823090|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823091|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823092|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823093|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823094|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823095|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823096|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823097|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823098|NCT01316380|O3|Outcome|Tio R5|Patients treated with tiotropium inhalation solution 5 microgram qd
823099|NCT01316380|O2|Outcome|Tio R2.5|Patients treated with tiotropium inhalation solution 2.5 microgram qd
823100|NCT01316380|O1|Outcome|Placebo|Patients treated with matching placebo
823101|NCT01316380|E3|Reported Event|Tio R5|Enter description here, if needed
823102|NCT01316380|E2|Reported Event|Tio R2.5|Enter description here, if needed
823103|NCT01316380|E1|Reported Event|Placebo|Enter description here, if needed
823104|NCT01316341|B4|Baseline|Total|Total of all reporting groups
823105|NCT01316341|B3|Baseline|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
823187|NCT01316315|O1|Outcome|N6022|Patients received a single IV administration of 5 mL of N6022 on Day 1 in each treatment period and single dose of placebo on Day 1 of the second period.
823106|NCT01316341|B2|Baseline|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
823107|NCT01316341|B1|Baseline|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
823108|NCT01316341|P3|Participant Flow|Empa 25 mg|25 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
823109|NCT01316341|P2|Participant Flow|Empa 10 mg|10 mg Empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
823110|NCT01316341|P1|Participant Flow|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
823111|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823112|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823113|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
823114|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823115|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823116|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally for 7 consecutive days.
823117|NCT01316341|O3|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
823118|NCT01316341|O2|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
823119|NCT01316341|O1|Outcome|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
823120|NCT01316341|O2|Outcome|Empa 25 mg|A single dose of 25 mg empagliflozin (empa) taken orally, plus one placebo tablet.
823121|NCT01316341|O1|Outcome|Empa 10 mg|A single dose of 10 mg Empagliflozin (empa) taken orally, plus one placebo tablet.
823122|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823123|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823124|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823125|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823126|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823127|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823128|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823129|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823130|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823131|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823132|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823133|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823134|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823135|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823136|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823137|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823138|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823188|NCT01316315|E2|Reported Event|Placebo|Non-Active
823139|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823140|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823141|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823142|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823143|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823144|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823145|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823146|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 10mg empa tablet taken at each drug administration.
823147|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally once daily for 7 consecutive days, plus a placebo tablet matching the 25mg empa tablet taken at each drug administration.
823148|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823149|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823150|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823151|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823152|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823153|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823154|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823155|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823156|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823157|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823158|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823159|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823160|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823161|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823162|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823163|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823164|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823165|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823166|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823167|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823168|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823169|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823170|NCT01316341|O2|Outcome|Empa 25 mg|25 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 10mg empa tablet.
823171|NCT01316341|O1|Outcome|Empa 10 mg|10 mg empagliflozin (empa) taken orally as a single dose, plus a placebo tablet matching the 25mg empa tablet.
823172|NCT01316341|E3|Reported Event|Empa 25 mg|25 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 10mg empa tablet was taken at each drug administration.
823173|NCT01316341|E2|Reported Event|Empa 10 mg|10 mg empagliflozin (empa) taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period). Along with this a placebo tablet matching the 25mg empa tablet was taken at each drug administration.
823174|NCT01316341|E1|Reported Event|Placebo|Two placebo tablets, one matching the empa 10mg tablet and one matching the empa 25mg tablet, taken orally either as a single dose (single dose period) or for 7 consecutive days (multiple dose period).
823175|NCT01316315|B3|Baseline|Total|Total of all reporting groups
823176|NCT01316315|B2|Baseline|Placebo|Non-Active
823177|NCT01316315|B1|Baseline|Active|N6022 - 5 mg
823178|NCT01316315|P2|Participant Flow|Placebo|Non-Active
823179|NCT01316315|P1|Participant Flow|Active|N6022 - Active 5 mg
823180|NCT01316315|O2|Outcome|Placebo|Non-Active
823181|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
823182|NCT01316315|O2|Outcome|Placebo|Non-Active
823183|NCT01316315|O1|Outcome|Active|N6022 - Active 5 mg
823191|NCT01316302|B2|Baseline|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
823192|NCT01316302|B1|Baseline|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
823193|NCT01316302|P2|Participant Flow|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
823194|NCT01316302|P1|Participant Flow|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
823195|NCT01316302|O2|Outcome|Placebo|Matching placebo
823196|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
823197|NCT01316302|O2|Outcome|Placebo|Matching placebo
823198|NCT01316302|O1|Outcome|Pristiq|Flexible dose, 50-100mg QD
823199|NCT01316302|O2|Outcome|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
823200|NCT01316302|O1|Outcome|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
823201|NCT01316302|E2|Reported Event|Placebo|"Matching placebo~Placebo: Matching placebo, taken QD for 12 weeks."
823202|NCT01316302|E1|Reported Event|Pristiq|"Flexible dose, 50-100mg QD~Pristiq: Flexible dose, 50-100mg QD, for 12 weeks."
823203|NCT01316263|B3|Baseline|Total|Total of all reporting groups
823204|NCT01316263|B2|Baseline|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823205|NCT01316263|B1|Baseline|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823206|NCT01316263|P2|Participant Flow|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823207|NCT01316263|P1|Participant Flow|PDGFRα Mutation Positive|20 milligrams per kilogram (mg/kg) of Olaratumab (IMC-3G3) was administered intravenously (IV) on Day 1 of each cycle (14-day cycles) to participants with gastrointestinal stromal tumors (GIST) with genotypes that had a platelet-derived growth factor receptor alpha (PDGFRα) mutation.
823208|NCT01316263|O1|Outcome|PDGFRα Mutation Positive and Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation and that did not have a PDGFRα mutation.
823209|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823210|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823211|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823212|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823213|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823214|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823215|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823216|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823217|NCT01316263|O1|Outcome|Olaratumab (IMC-3G3)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation or PDGFRα wild type.
823218|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823219|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823220|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823221|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823222|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823223|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823224|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823225|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823226|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823227|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823228|NCT01316263|O2|Outcome|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823229|NCT01316263|O1|Outcome|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823230|NCT01316263|E2|Reported Event|PDGFRα Mutation Negative (Wild-Type)|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that did not have a PDGFRα mutation.
823231|NCT01316263|E1|Reported Event|PDGFRα Mutation Positive|20 mg/kg of Olaratumab (IMC-3G3) was administered IV on Day 1 of each cycle (14-day cycles) to participants with GIST with genotypes that had a PDGFRα mutation.
823232|NCT01316224|B1|Baseline|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823233|NCT01316224|P1|Participant Flow|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823234|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823235|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823236|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823237|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823238|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823239|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823240|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823241|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823242|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823243|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823244|NCT01316224|O1|Outcome|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with adalimumab
823245|NCT01316224|E1|Reported Event|Moderate or Severe Psoriasis|Participants with moderate or severe psoriasis in treatment with Adalimumab
823246|NCT01316055|B4|Baseline|Total|Total of all reporting groups
823247|NCT01316055|B3|Baseline|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823248|NCT01316055|B2|Baseline|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823249|NCT01316055|B1|Baseline|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823250|NCT01316055|P3|Participant Flow|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823251|NCT01316055|P2|Participant Flow|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823252|NCT01316055|P1|Participant Flow|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823253|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823254|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823255|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823256|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823257|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823258|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823259|NCT01316055|O3|Outcome|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823260|NCT01316055|O2|Outcome|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823261|NCT01316055|O1|Outcome|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823262|NCT01316055|E3|Reported Event|Moderate Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with moderate renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823333|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823263|NCT01316055|E2|Reported Event|Mild Renal: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in volunteers with mild renal impairment~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823264|NCT01316055|E1|Reported Event|Healthy: Dalfampridine-ER 7.5 mg|"Dalfampridine-ER 7.5 mg single and steady-state dosing in healthy volunteers~Dalfampridine-ER : 2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up"
823265|NCT01316042|B3|Baseline|Total|Total of all reporting groups
823266|NCT01316042|B2|Baseline|Metformin|2 212.5mg pill/day for 12 months
823267|NCT01316042|B1|Baseline|Sugar Pill|2 pills per day for 12 months
823268|NCT01316042|P2|Participant Flow|Metformin|2 212.5mg pill/day for 12 months
823269|NCT01316042|P1|Participant Flow|Sugar Pill|2 pills per day for 12 months
823270|NCT01316042|O2|Outcome|Metformin|2 212.5mg pill/day for 12 months
823271|NCT01316042|O1|Outcome|Sugar Pill|2 pills per day for 12 months
823272|NCT01316042|E2|Reported Event|Metformin|2 212.5mg pill/day for 12 months
823273|NCT01316042|E1|Reported Event|Sugar Pill|2 pills per day for 12 months
823274|NCT01315847|B3|Baseline|Total|Total of all reporting groups
823275|NCT01315847|B2|Baseline|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823276|NCT01315847|B1|Baseline|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823277|NCT01315847|P2|Participant Flow|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823313|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
823985|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
823278|NCT01315847|P1|Participant Flow|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline positron emission tomography (PET) imaging of the brain using [11C]MK-4232 tracer (~300 megabecquerel [MBq]) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823279|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823280|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823294|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823334|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823281|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823282|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823283|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823284|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823285|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823286|NCT01315847|O1|Outcome|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823314|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
823315|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
823986|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823287|NCT01315847|E2|Reported Event|Telcagepant and [11C]MK-4232 (Part III): Migraineurs|In study Part III, Period 1 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine during a migraine attack (ictal phase). Later in Part III, Period 1 the participants with an ongoing migraine attack (ictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose. In Part III, Period 2 baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in participants with migraine, however, without a migraine attack ongoing (interictal phase). Later in Part III, Period 2 participants with migraine without a migraine attack ongoing (interictal phase) received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823288|NCT01315847|E1|Reported Event|Telcagepant and [11C]MK-4232 (Part I): Healthy Participants|Baseline PET imaging of the brain using [11C]MK-4232 tracer (~300 MBq) was performed in healthy participants; this PET data served as the baseline for both Period 1 and 2 of Part I. Subsequently in study Part I, Period 1 the healthy participants received a single 1120 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~3 hours post telcagepant dose. In Part I, Period 2 the healthy participants received a single 140 mg dose of telcagepant followed by PET imaging of brain with [11C]MK-4232 tracer (~300 MBq) beginning ~2 hours post telcagepant dose.
823289|NCT01315665|B3|Baseline|Total|Total of all reporting groups
823290|NCT01315665|B2|Baseline|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823291|NCT01315665|B1|Baseline|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823292|NCT01315665|P2|Participant Flow|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823293|NCT01315665|P1|Participant Flow|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823295|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823296|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823297|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823298|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823299|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823300|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823301|NCT01315665|O1|Outcome|Healthy Volunteers|"100 grams of raw broccoli sprouts once daily for 5 consecutive days~Broccoli sprouts: Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823302|NCT01315665|O2|Outcome|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823303|NCT01315665|O1|Outcome|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823304|NCT01315665|E2|Reported Event|Subjects With Cystic Fibrosis|"Subjects with cystic fibrosis~Broccoli sprouts: Subjects with cystic fibrosis will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823305|NCT01315665|E1|Reported Event|Healthy Volunteers|"Healthy volunteers~Broccoli sprouts: Healthy volunteers will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days."
823306|NCT01315574|B3|Baseline|Total|Total of all reporting groups
823307|NCT01315574|B2|Baseline|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
823308|NCT01315574|B1|Baseline|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
823309|NCT01315574|P2|Participant Flow|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
823310|NCT01315574|P1|Participant Flow|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
823311|NCT01315574|O2|Outcome|Travoprost (Travatan Z)|"7 Patients were randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
823312|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
823316|NCT01315574|O1|Outcome|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
823317|NCT01315574|E2|Reported Event|Travoprost (Travatan Z)|"7 Patients were be randomized to receive BAK-free Travatan Z for treatment of their glaucoma.~Travoprost: One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily."
823318|NCT01315574|E1|Reported Event|Latanoprost (Xalatan)|"7 Patients were randomized to receive BAK-containing Xalatan for treatment of their glaucoma.~Latanoprost: One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily."
823319|NCT01315249|B3|Baseline|Total|Total of all reporting groups
823320|NCT01315249|B2|Baseline|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823321|NCT01315249|B1|Baseline|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823322|NCT01315249|P2|Participant Flow|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823323|NCT01315249|P1|Participant Flow|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823324|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823325|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823326|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823327|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823328|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823329|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823330|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823331|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823332|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823335|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823336|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823337|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823338|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823339|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823340|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823341|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823342|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823343|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823344|NCT01315249|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823345|NCT01315249|O1|Outcome|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823346|NCT01315249|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).
823347|NCT01315249|E1|Reported Event|QVA149|Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
823348|NCT01315158|B3|Baseline|Total|Total of all reporting groups
823349|NCT01315158|B2|Baseline|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823350|NCT01315158|B1|Baseline|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823351|NCT01315158|P2|Participant Flow|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823365|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823997|NCT01313637|B3|Baseline|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
823352|NCT01315158|P1|Participant Flow|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823353|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823354|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823355|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823356|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823393|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
823766|NCT01313923|O1|Outcome|Sirolimus (Formerly Known as Rapamycin)|No results. Study has been terminated by investigator.
823357|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823358|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823359|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823360|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823361|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823362|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823363|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823364|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823385|NCT01315028|P2|Participant Flow|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
823366|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823367|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823368|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823369|NCT01315158|O2|Outcome|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823370|NCT01315158|O1|Outcome|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823371|NCT01315158|E2|Reported Event|Propofol Alone|"The patients randomized into the sedation with propofol alone are able to cross over if they are unable to be successfully sedated under propofol alone. The the recommended doses before considering crossover are standardized:~Induction Dose: 2-2.5 mg/kg~Maintenance Dose: 0.1-0.2 mg/kg/min~Propofol Alone: Recommended Propofol doses before considering crossover:~Induction: 2-2.5 mg/kg~Maintenance: 0.1-0.2 mg/kg/min"
823372|NCT01315158|E1|Reported Event|Propofol+Benzo/Opioids|"If the patient is randomized into this arm the recommended Versed and Fentanyl doses are standardized:~Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~Recommended Fentanyl~Prior to intubation = 0.5 ug/kg~Total procedural dose = 1 ug/kg~Propofol+Benzo/Opioids: 1. Recommended Versed:~a. Prior to intubation~patient is < 50 kg = 1 mg Versed~patient is 50-75 kg = 1.5 mg Versed~patient is > 75 kg = 2 mg Versed~2. Recommended Fentanyl~a. Prior to intubation = 0.5 ug/kg b. Total procedural dose = 1 ug/kg"
823373|NCT01315145|B3|Baseline|Total|Total of all reporting groups
823374|NCT01315145|B2|Baseline|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
823375|NCT01315145|B1|Baseline|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
823376|NCT01315145|P2|Participant Flow|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
823377|NCT01315145|P1|Participant Flow|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
823378|NCT01315145|O2|Outcome|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
823379|NCT01315145|O1|Outcome|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
823380|NCT01315145|E2|Reported Event|Lumbar Epidural Steroid Injection|"Injection of epidural steroids into the lumbar spine~Epidural Steroid Injection: Injection of epidural steroids into the lumbar spine"
823381|NCT01315145|E1|Reported Event|Percutaneous Lumbar Decompression|"Patients receiving percutaneous decompression using the mild® Device Kit.~Percutaneous Lumbar Decompression: The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue."
823382|NCT01315028|B3|Baseline|Total|Total of all reporting groups
823383|NCT01315028|B2|Baseline|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
823384|NCT01315028|B1|Baseline|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
823987|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
823386|NCT01315028|P1|Participant Flow|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
823387|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
823388|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
823389|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
823390|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
823391|NCT01315028|O2|Outcome|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
823392|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
824015|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823394|NCT01315028|O1|Outcome|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
823395|NCT01315028|E2|Reported Event|Treatment As Usual|Normal Clinical Care : The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
823396|NCT01315028|E1|Reported Event|Psychological Therapy|Cognitive Interpersonal Therapy : Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
823397|NCT01315002|B1|Baseline|All Study Participants|Includes groups randomized to receive nicotine first and placebo first. Number of all study participants = 121.
823398|NCT01315002|P2|Participant Flow|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
823399|NCT01315002|P1|Participant Flow|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
823400|NCT01315002|O2|Outcome|Placebo Patch|"Placebo patch~Placebo patch: Placebo patch"
823401|NCT01315002|O1|Outcome|Nicotine Patch|"Transdermal nicotine patch~Transdermal nicotine patch: 7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)"
823402|NCT01315002|E2|Reported Event|Placebo First, Then Nicotine|"Placebo patch first (single application), then transdermal nicotine patch (single application, one week after administration of placebo patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
823403|NCT01315002|E1|Reported Event|Nicotine First, Then Placebo|"Transdermal nicotine patch first (single application), then placebo patch (single application, one week after administration of nicotine patch)~Doses:~non-smokers: 7mg transdermal nicotine patch smokers: 14mg transdermal nicotine patch"
823404|NCT01314872|B12|Baseline|Total|Total of all reporting groups
823405|NCT01314872|B11|Baseline|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
823406|NCT01314872|B10|Baseline|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
823407|NCT01314872|B9|Baseline|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823408|NCT01314872|B8|Baseline|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823409|NCT01314872|B7|Baseline|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823410|NCT01314872|B6|Baseline|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823411|NCT01314872|B5|Baseline|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823412|NCT01314872|B4|Baseline|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823413|NCT01314872|B3|Baseline|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823414|NCT01314872|B2|Baseline|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823415|NCT01314872|B1|Baseline|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823416|NCT01314872|P15|Participant Flow|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823417|NCT01314872|P14|Participant Flow|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823418|NCT01314872|P13|Participant Flow|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823456|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823767|NCT01313923|E1|Reported Event|Sirolimus (Formerly Known as Rapamycin)|No results as study has been terminated early by the investigator.
823419|NCT01314872|P12|Participant Flow|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823420|NCT01314872|P11|Participant Flow|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
823421|NCT01314872|P10|Participant Flow|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
823422|NCT01314872|P9|Participant Flow|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823423|NCT01314872|P8|Participant Flow|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823424|NCT01314872|P7|Participant Flow|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823425|NCT01314872|P6|Participant Flow|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823426|NCT01314872|P5|Participant Flow|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823427|NCT01314872|P4|Participant Flow|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823428|NCT01314872|P3|Participant Flow|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823429|NCT01314872|P2|Participant Flow|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823430|NCT01314872|P1|Participant Flow|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823431|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823432|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823433|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823434|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823435|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823436|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823437|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823457|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823458|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823768|NCT01313910|B1|Baseline|ImmunoLin®|8-week treatment course
823438|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823439|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823440|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823441|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823442|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823443|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823444|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823445|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823446|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823447|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823988|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
823448|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823449|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823450|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823451|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823452|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823453|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823454|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823455|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823769|NCT01313910|P1|Participant Flow|ImmunoLin®|2.5 grams twice daily for eight weeks
823459|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823460|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823461|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823462|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823463|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823464|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823465|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823466|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823467|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823468|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823469|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823470|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823471|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823472|NCT01314872|O4|Outcome|Extension Study: Vibegron 100 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823473|NCT01314872|O3|Outcome|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823474|NCT01314872|O2|Outcome|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823475|NCT01314872|O1|Outcome|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823476|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
823477|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
823478|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823479|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823553|NCT01314443|B3|Baseline|Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of NRT
823480|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823481|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823482|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823483|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823484|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823485|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823486|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823487|NCT01314872|O11|Outcome|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
823488|NCT01314872|O10|Outcome|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
823489|NCT01314872|O9|Outcome|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823490|NCT01314872|O8|Outcome|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823491|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823492|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823493|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823494|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823495|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823496|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823497|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823498|NCT01314872|O7|Outcome|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823499|NCT01314872|O6|Outcome|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
824085|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
823500|NCT01314872|O5|Outcome|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823501|NCT01314872|O4|Outcome|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823502|NCT01314872|O3|Outcome|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823503|NCT01314872|O2|Outcome|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823504|NCT01314872|O1|Outcome|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823505|NCT01314872|E15|Reported Event|Extension Study: Vibegron 50 mg + Tolterodine ER 4 mg|Participants in Base Study/Part 1 who received vibegron 100 mg + tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 2 who received placebo were assigned to the vibegron 100 mg + tolterodine ER 4 mg arm in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 52 weeks.
823506|NCT01314872|E14|Reported Event|Extension Study: Tolterodine ER 4 mg|Participants in Base Study/Part 1 or Part 2 who received tolterodine ER 4 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received placebo also received tolterodine ER 4 mg in the Extension Study. In the extension, participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 52 weeks.
823554|NCT01314443|B2|Baseline|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
823770|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
823507|NCT01314872|E13|Reported Event|Extension Study: Vibegron 100 mg|Participants in Base Study/Part 1 or Part 2 who received vibegron 100 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 15 mg received vibegron 100 mg in the Extension Study. In the extension, participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823508|NCT01314872|E12|Reported Event|Extension Study: Vibegron 50 mg|Participants in Base Study/Part 1 who received vibegron 50 mg continued their treatment in the Extension Study. In addition, participants in Base Study/Part 1 who received vibegron 3 mg received vibegron 50 mg in the Extension Study. Also, participants in Base Study/Part 1 who received vibegron 50 mg + tolterodine ER for 4 weeks, followed by vibegron 50 mg alone for 4 weeks, remained on vibegron 50 mg in the Extension Study. In the extension, participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 52 weeks.
823509|NCT01314872|E11|Reported Event|Part 2: Vibegron 100 mg + Tolterodine ER 4 mg|Participants received two vibegron 50 mg tablets and one tolterodine ER 4 mg capsule, taken orally each morning, for 4 weeks.
823510|NCT01314872|E10|Reported Event|Part 2: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 4 weeks.
823511|NCT01314872|E9|Reported Event|Part 2: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823512|NCT01314872|E8|Reported Event|Part 2: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 4 weeks.
823513|NCT01314872|E7|Reported Event|Part 1: Vibegron 50 mg + Tolterodine ER 4 mg/Vibegron 50 mg|Participants received one vibegron 50 mg tablet and one placebo matching vibegron tablet, taken orally each morning, for 8 weeks. They also received one tolterodine ER 4 mg capsule for the first 4 weeks and one placebo matching tolterodine ER capsule for the second 4 weeks, both taken orally each morning.
823514|NCT01314872|E6|Reported Event|Part 1: Tolterodine ER 4 mg|Participants received one tolterodine ER 4 mg capsule and two placebo matching vibegron tablets, taken orally each morning, for 8 weeks.
823515|NCT01314872|E5|Reported Event|Part 1: Vibegron 100 mg|Participants received two vibegron 50 mg tablets and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823516|NCT01314872|E4|Reported Event|Part 1: Vibegron 50 mg|Participants received one vibegron 50 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823517|NCT01314872|E3|Reported Event|Part 1: Vibegron 15 mg|Participants received one vibegron 15 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823518|NCT01314872|E2|Reported Event|Part 1: Vibegron 3 mg|Participants received one vibegron 3 mg tablet, one placebo matching vibegron tablet, and one placebo matching tolterodine ER capsule, taken orally each morning, for 8 weeks.
823519|NCT01314872|E1|Reported Event|Part 1: Placebo|Participants received two placebo matching vibegron tablets and one placebo matching tolterodine extended release (ER) capsule, taken orally each morning, for 8 weeks.
823520|NCT01314742|B3|Baseline|Total|Total of all reporting groups
823521|NCT01314742|B2|Baseline|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
823522|NCT01314742|B1|Baseline|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
823523|NCT01314742|P2|Participant Flow|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
823579|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823524|NCT01314742|P1|Participant Flow|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
823525|NCT01314742|O2|Outcome|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
823526|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
823527|NCT01314742|O2|Outcome|Sterile Water Group|Study group receiving timed oral care with Sterile Water
823528|NCT01314742|O1|Outcome|Biotene OralBalance® Gel Arm|Study group receiving timed oral care with Biotene OralBalance® gel Arm
823529|NCT01314742|E2|Reported Event|Sterile Water Arm|Sterile Water moisten cotton tipped applicator : One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
823771|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
823530|NCT01314742|E1|Reported Event|Biotene OralBalance® Gel Arm|"Biotene OralBalance® gel contains antibacterial active ingredients: lactoperoxidase, lysozyme and lactoferrin. These enzymes occur naturally in the human milk and colostrum and have mimicking properties of the human saliva activity in vivo.~Biotene OralBalance® gel : Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization."
823531|NCT01314716|B3|Baseline|Total|Total of all reporting groups
823532|NCT01314716|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823533|NCT01314716|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823534|NCT01314716|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
823535|NCT01314716|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 84 days.
823536|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823537|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823538|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823539|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823540|NCT01314716|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823541|NCT01314716|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823542|NCT01314716|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823543|NCT01314716|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823580|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823544|NCT01314716|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823545|NCT01314716|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
823546|NCT01314703|B1|Baseline|Group 1|All subjects received treatment with both the test article and the positive control
823547|NCT01314703|P1|Participant Flow|ChloraPrep and 70% Isopropyl Alcohol|All subjects received treatment with both the ChloraPrep and 70% Isopropyl Alcohol
823548|NCT01314703|O2|Outcome|70% Isopropyl Alcohol, 10.5 mL Applicator|All subjects received single application of treatment with 70% Isopropyl Alcohol 10.5 mL Applicator on two treatment sites (abdomen and groin).
823549|NCT01314703|O1|Outcome|ChloraPrep One Step, 10.5 mL Applicator|All subjects received single application of treatment with ChloraPrep One Step 10.5 mL Applicator on two treatment sites (abdomen and groin).
823550|NCT01314703|E1|Reported Event|Group 1|All subjects received treatment with both the test article and the positive control
823551|NCT01314443|B5|Baseline|Total|Total of all reporting groups
823552|NCT01314443|B4|Baseline|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of NRT
823555|NCT01314443|B1|Baseline|Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
823556|NCT01314443|P4|Participant Flow|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823557|NCT01314443|P3|Participant Flow|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823558|NCT01314443|P2|Participant Flow|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
823559|NCT01314443|P1|Participant Flow|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
823560|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823561|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823562|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
823563|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
823564|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823565|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823566|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
823567|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
823568|NCT01314443|O4|Outcome|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823569|NCT01314443|O3|Outcome|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823570|NCT01314443|O2|Outcome|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
823571|NCT01314443|O1|Outcome|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
823572|NCT01314443|E4|Reported Event|Placebo + Nicotine Replacement Therapy|Individuals will ingest placebo for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823573|NCT01314443|E3|Reported Event|Dietary Supplement + Nicotine Replacement Therapy|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation with the use of nicotine replacement therapy
823574|NCT01314443|E2|Reported Event|Placebo + Smoking Cessation|Individuals will ingest placebo for 7 days while undergoing smoking cessation without any aids
823575|NCT01314443|E1|Reported Event|Dietary Supplement + Smoking Cessation|Individuals will ingest gamma-tocopherol (500 mg/d) for 7 days while undergoing smoking cessation without any aids
823576|NCT01314417|B1|Baseline|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823577|NCT01314417|P1|Participant Flow|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823578|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823581|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823582|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823583|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823584|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823585|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823586|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823587|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823588|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823589|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823590|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823591|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823772|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
823773|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
823592|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823593|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823594|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823595|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823596|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823597|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823598|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823599|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823600|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823601|NCT01314417|O1|Outcome|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823602|NCT01314417|E1|Reported Event|Methotrexate|Participants will receive an intravitreal injection of 400 μg per 100 μL of methotrexate at baseline and Weeks 4 and 8, then as needed per the treatment criteria.
823603|NCT01314261|B5|Baseline|Total|Total of all reporting groups
823604|NCT01314261|B4|Baseline|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823605|NCT01314261|B3|Baseline|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823606|NCT01314261|B2|Baseline|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823607|NCT01314261|B1|Baseline|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823608|NCT01314261|P4|Participant Flow|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823609|NCT01314261|P3|Participant Flow|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823610|NCT01314261|P2|Participant Flow|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823611|NCT01314261|P1|Participant Flow|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823612|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823613|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823614|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823615|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823616|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823774|NCT01313910|O1|Outcome|ImmunoLin®|8-week treatment course
823775|NCT01313910|E1|Reported Event|ImmunoLin®|8-week treatment course
823617|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823618|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823619|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823620|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823621|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823622|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823623|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823624|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823625|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823626|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823627|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823628|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823629|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823630|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823631|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823632|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823633|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823634|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823635|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823636|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823637|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823638|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823639|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823640|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823641|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823642|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823643|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823644|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823645|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823646|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823647|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823648|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823649|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823650|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823651|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823652|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823653|NCT01314261|O4|Outcome|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823654|NCT01314261|O3|Outcome|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823655|NCT01314261|O2|Outcome|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 50 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823656|NCT01314261|O1|Outcome|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks, followed by 36 weeks of pegIFN/RBV treatment alone. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823657|NCT01314261|E4|Reported Event|Placebo + pegIFN/RBV|Participants were given matching placebo to ABT-267 once daily in combination with pegIFN/RBV for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823658|NCT01314261|E3|Reported Event|ABT-267 (200 mg) Once Daily + pegIFN/RBV|Participants were given 200 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823659|NCT01314261|E2|Reported Event|ABT-267 (50 mg) Once Daily + pegIFN/RBV|Participants were given 10 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823660|NCT01314261|E1|Reported Event|ABT-267 (5 mg) Once Daily + pegIFN/RBV|Participants were given 5 mg ABT-267 once daily in combination with pegylated interferon/ribavirin (pegIFN/RBV) for 12 weeks. Pegylated interferon was dosed 180 µg subcutaneously once a week. Ribavirin was dosed 1000 or 1200 mg daily divided twice a day.
823661|NCT01314118|B1|Baseline|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
823662|NCT01314118|P1|Participant Flow|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
823663|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
823664|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
823665|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
823666|NCT01314118|O1|Outcome|Abiraterone Acetate and Prednisone|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
823690|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823989|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
823667|NCT01314118|E1|Reported Event|Abiraterone Acetate|Participants were given Abiraterone Acetate 1000 milligram (mg) (4*250 mg) tablets and Prednisone 5 mg (2*2.5 mg) tablets orally once daily in Core Study Treatment Phase (comprised of 6, 28 day cycles). After the Core Study Treatment Phase, participants who entered the Pre-metastatic Disease Follow-up Phase continued the study treatment until radiographic confirmation of disease progression, intolerable toxicity, investigator’s decision, and withdrawal by participant or until the sponsor decided to stop the trial.
823668|NCT01314105|B3|Baseline|Total|Total of all reporting groups
823669|NCT01314105|B2|Baseline|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823670|NCT01314105|B1|Baseline|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823671|NCT01314105|P2|Participant Flow|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823672|NCT01314105|P1|Participant Flow|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823673|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823674|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823675|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823676|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823677|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823678|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823679|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823680|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823681|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823682|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823683|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823684|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823685|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823686|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823687|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823688|NCT01314105|O1|Outcome|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823689|NCT01314105|O2|Outcome|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823788|NCT01313858|P3|Participant Flow|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823691|NCT01314105|E2|Reported Event|Nintedanib 200mg|Nintedanib (200 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823692|NCT01314105|E1|Reported Event|Nintedanib 150mg|Nintedanib (150 mg twice daily (BID), except the day of chemotherapy infusion) administered orally plus standard therapy of Carboplatin (Area Under the Curve (AUC) 5 mg/mL*min) and PLD (30 mg/m2) which were administered by intravenous infusion once every 28 days.
823693|NCT01314014|B1|Baseline|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
823694|NCT01314014|P1|Participant Flow|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
823717|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823695|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
823696|NCT01314014|O1|Outcome|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
823697|NCT01314014|E1|Reported Event|Imexon|"Subjects will be treated on Days 1-5 of 21-day treatment cycles for up to one year. Following pre-treatment with anti-emetics Amplimexon will be given by intravenous infusion over 60 minutes.~Imexon: Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment."
823698|NCT01314001|B7|Baseline|Total|Total of all reporting groups
823699|NCT01314001|B6|Baseline|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823700|NCT01314001|B5|Baseline|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823701|NCT01314001|B4|Baseline|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823702|NCT01314001|B3|Baseline|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823703|NCT01314001|B2|Baseline|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823704|NCT01314001|B1|Baseline|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823705|NCT01314001|P6|Participant Flow|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823706|NCT01314001|P5|Participant Flow|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823707|NCT01314001|P4|Participant Flow|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823708|NCT01314001|P3|Participant Flow|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823709|NCT01314001|P2|Participant Flow|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823710|NCT01314001|P1|Participant Flow|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
824087|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
823711|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823712|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823713|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823714|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823715|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823716|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823765|NCT01313923|P1|Participant Flow|Sirolimus|There is one arm to the study. All patients will be open-label, Sirolimus. There is no set dosage: medication dose will be based on FDA approved guidelines.
823718|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823719|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823720|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823721|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823722|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823723|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823724|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823725|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823726|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823727|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823728|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823729|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823730|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823731|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823732|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823733|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823734|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823735|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823736|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823737|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823738|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823739|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823740|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823741|NCT01314001|O6|Outcome|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823742|NCT01314001|O5|Outcome|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823743|NCT01314001|O4|Outcome|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
824051|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
823744|NCT01314001|O3|Outcome|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823745|NCT01314001|O2|Outcome|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823746|NCT01314001|O1|Outcome|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823747|NCT01314001|E6|Reported Event|Varenicline (Normal Metabolizers)|"Normal metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823748|NCT01314001|E5|Reported Event|Varenicline (Slow Metabolizers)|"Slow metabolizers~Taking active varenicline pills daily for 12 weeks (3 days of 0.5mg daily, 4 days of 0.5mg twice daily, and 77 days of 1mg twice daily)~Wearing placebo patches for 11 weeks~Received smoking cessation counseling during their sessions"
823749|NCT01314001|E4|Reported Event|Nicotine Patch (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823750|NCT01314001|E3|Reported Event|Nicotine Patch (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing active nicotine patches for 11 weeks (6 weeks of 21mg, 2 weeks of 14mg, 3 weeks of 7mg)~Received smoking cessation counseling during their sessions"
823751|NCT01314001|E2|Reported Event|Placebo (Normal Metabolizers)|"Normal metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823752|NCT01314001|E1|Reported Event|Placebo (Slow Metabolizers)|"Slow metabolizers~Taking placebo pills daily for 12 weeks~Wearing placebo patches daily for 11 weeks~Received smoking cessation counseling during their sessions"
823753|NCT01313936|B3|Baseline|Total|Total of all reporting groups
823754|NCT01313936|B2|Baseline|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823755|NCT01313936|B1|Baseline|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823756|NCT01313936|P2|Participant Flow|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823757|NCT01313936|P1|Participant Flow|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823758|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823759|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823789|NCT01313858|P2|Participant Flow|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823760|NCT01313936|O2|Outcome|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823761|NCT01313936|O1|Outcome|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823762|NCT01313936|E2|Reported Event|18 mCi/kg of 131I-MIBG|"The second cohort will be 3-6 patients at the same doses of vincristine and irinotecan and 18 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823763|NCT01313936|E1|Reported Event|15 mCi/kg of 131I-MIBG|"The first cohort for safety will be 3-6 patients treated with vincristine and irinotecan and 15 mCi/kg of 131I-MIBG.~Metaiodobenzylguanidine (MIBG): Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42."
823764|NCT01313923|B1|Baseline|Sirolimus|All patient will be open-label; Sirolimus. Dosage is variable based on FDA guidelines.
824052|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
823776|NCT01313897|B1|Baseline|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
823777|NCT01313897|P1|Participant Flow|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
823778|NCT01313897|O1|Outcome|Velcade for Anti-MM Therapy|"Day(s) -9,-6,-2 3 doses of Bortezomib at 1.0 mg/m2, i.v.~Bortezomib: bortezomib given days -9, -6, and -2 at 1.0mg/m2, i.v."
823779|NCT01313897|E1|Reported Event|Study Treatment|Bortezomib (1.0 mg/m2, IV) Days -9,-6,-2 (3 doses) Mesna (30 mg/kg, IV) Days -7, -6 (2 doses) Cyclophasphamide (60 mg/kg, IV) Day -7 (1 dose) Dexamethasone (40 mg, PO) Days -6 to -3 (4 doses) Expanded Natural Killer (exp-NK) Cell Infusion Day 0 (1 dose) Aldesleukin (IL-2) (3x10^6 IU, SC) Days 0 to 12 (13 doses)
823780|NCT01313884|B1|Baseline|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
823781|NCT01313884|P1|Participant Flow|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
823782|NCT01313884|O1|Outcome|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
823783|NCT01313884|E1|Reported Event|Combination Therapy|"Regimen A alternate with Regimen B every 21 days~Regimen A:~Cytoxan=1200mg/m2 Doxorubicin=75mg/m2 (Maxiumum allowed dose 450mg/m2) Vincristine=2mg/m2 (capped at 2mg total dose)~Regimen B:~Irinotecan=50 mg/m2/day x 5 days Temozolomide=100 mg/m2/day x 5 days followed by two weeks of treatment-free period.~Irinotecan: 50 mg/m2/day x 5 days~Vincristine: 2 mg/m2 (capped at 2mg total do)~Temozolomide: 100 mg/m2/day x 5 days~Doxorubicin: 75 mg/m2~Cytoxan: 1200 mg/m2~Pegfilgrastim: 6 mg~Mesna: 240 mg/m2 in 50 ml NS"
823784|NCT01313858|B4|Baseline|Total|Total of all reporting groups
823785|NCT01313858|B3|Baseline|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823786|NCT01313858|B2|Baseline|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823787|NCT01313858|B1|Baseline|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
824627|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
823790|NCT01313858|P1|Participant Flow|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
823791|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823792|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823793|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
823794|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823795|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823796|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
823797|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823798|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823799|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
823800|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823801|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823802|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
823803|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823804|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823805|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
823806|NCT01313858|O3|Outcome|Participants With Ankylosing Spondylitis|Simponi®-naïve participants with ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823807|NCT01313858|O2|Outcome|Participants With Psoriatic Arthritis|Simponi®-naïve participants with psoriatic arthritis given Simponi® 50 mg once a month as a subcutaneous injection.
823808|NCT01313858|O1|Outcome|Participants With Rheumatoid Arthritis|Simponi®-naïve participants with rheumatoid arthritis given Simponi® 50 mg once a month as a subcutaneous injection. Combination use with methotrexate was recommended.
823809|NCT01313858|E1|Reported Event|All Participants|Simponi®-naïve participants with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis given Simponi® 50 mg once a month as a subcutaneous injection.
823810|NCT01313780|B3|Baseline|Total|Total of all reporting groups
823811|NCT01313780|B2|Baseline|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
823812|NCT01313780|B1|Baseline|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
823813|NCT01313780|P2|Participant Flow|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
823814|NCT01313780|P1|Participant Flow|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
823815|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
823816|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
823817|NCT01313780|O2|Outcome|Oxycodone|Trade name is Oxycontin. Daily dose can be titrated up to 40mg B.I.D.
823818|NCT01313780|O1|Outcome|Oxycodone and Naloxone|Trade name is TARGIN. Daily dose can be titrated up to 40mg B.I.D.
823819|NCT01313780|E2|Reported Event|Oxycodone|oxycodone : Trade name is Oxycontin
823820|NCT01313780|E1|Reported Event|Oxycodone and Naloxone|Oxycodone and naloxone: Trade name is TARGIN.
823821|NCT01313728|B1|Baseline|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
823822|NCT01313728|P1|Participant Flow|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
823823|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
823824|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
823825|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
823826|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
823827|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
823828|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
823829|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
823830|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
823831|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
823832|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
823833|NCT01313728|O2|Outcome|Tretinoin Gel Alone|Tretinoin gel applied once daily to the assigned side of the face
823834|NCT01313728|O1|Outcome|Dapsone Gel + Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks - all subjects participate in both arms in a split-face model
823835|NCT01313728|E1|Reported Event|Overall Study|This was a single-group study with two treatment arms using a split-face model, i.e., all subjects received both interventions on opposite sides of the face.
823836|NCT01313689|B3|Baseline|Total|Total of all reporting groups
823837|NCT01313689|B2|Baseline|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823922|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823923|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823838|NCT01313689|B1|Baseline|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823839|NCT01313689|P4|Participant Flow|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823840|NCT01313689|P3|Participant Flow|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823841|NCT01313689|P2|Participant Flow|Physician's Choice|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823842|NCT01313689|P1|Participant Flow|Ofatumumab|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823913|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823914|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823843|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823844|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823924|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823925|NCT01313676|E4|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
824053|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
823845|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823846|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823847|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823848|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823849|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823850|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823915|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823990|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823851|NCT01313689|O3|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823852|NCT01313689|O2|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823853|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823854|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823855|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823856|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823857|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823858|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823916|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period
823917|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823859|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823926|NCT01313676|E3|Reported Event|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823927|NCT01313676|E2|Reported Event|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
824016|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
823860|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823861|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823862|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823863|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823864|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823865|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823866|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823991|NCT01313650|E4|Reported Event|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
823992|NCT01313650|E3|Reported Event|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
823928|NCT01313676|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823929|NCT01313663|B3|Baseline|Total|Total of all reporting groups
824017|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
824018|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
824019|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823867|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823868|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823869|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823870|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823871|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823872|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823873|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823874|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823918|NCT01313676|O3|Outcome|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823993|NCT01313650|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
823875|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823876|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823877|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823878|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823879|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823880|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823881|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823882|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823919|NCT01313676|O2|Outcome|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823994|NCT01313650|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823883|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823884|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823885|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823886|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823887|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823888|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823889|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823890|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823920|NCT01313676|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823995|NCT01313637|B5|Baseline|Total|Total of all reporting groups
824732|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
823891|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823892|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823893|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823894|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823895|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823896|NCT01313689|O4|Outcome|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823897|NCT01313689|O3|Outcome|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823898|NCT01313689|O2|Outcome|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823921|NCT01313676|O4|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823996|NCT01313637|B4|Baseline|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
823899|NCT01313689|O1|Outcome|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823900|NCT01313689|E4|Reported Event|Ofatumumab Observation|Par. randomized to receive OFA at Randomization 1 and receiving no treatment at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 received no treatment for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or at end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823901|NCT01313689|E3|Reported Event|Ofatumumab Extended|Par. randomized to receive OFA at Randomization 1 and at Randomization 2. Only the par. who did not demonstrate PD during the first 24 weeks of OFA therapy entered Randomization 2. At Randomization 1, par. were initially administered OFA 300 mg IV. Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Par. randomized to Randomization 2 continued to receive OFA 2000 mg IV every 4 weeks for another 24 weeks. Par. entered Follow-up after the treatment period until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823902|NCT01313689|E2|Reported Event|Physician's Choice (PC)|Par. randomized to receive PC trt during Randomization 1 were administered treatments approved for Chronic Lymphocytic Leukaemia (CLL) and well-established standards of care as prescribed with standard dose and route. Experimental therapies or any doses beyond the approved/standard of care dose ranges were not allowed. Par. who developed PD during PC trt or Follow-up had the option to receive (single-agent) OFA salvage trt. Par. received an initial IV dose of OFA 300 mg. One week later, par. received OFA 2000 mg followed by 7 weekly infusions of OFA 2000 mg, followed by infusions of OFA 2000 mg every 4 weeks until Week 48, for the maximum trt duration of 48 weeks. Par. entered Follow-up after the OFA salvage trt until withdrawal or the end of study (60 months). Par. entered SFU if demonstrating PD during OFA salvage trt. Only the survival status and anti-cancer therapy information was collected in the SFU. Par. who did not receive OFA salvage trt and demonstrated PD, entered SFU.
823903|NCT01313689|E1|Reported Event|Ofatumumab (OFA)|Participants (par.) were randomized to receive ofatumumab (OFA) at Randomization 1. Par. were initially administered OFA 300 milligrams (mg) intravenously (IV). Beginning at Week 2, par. were administered OFA 2000 mg once weekly for 7 weeks, followed by 4 infusions of OFA 2000 mg every 4 weeks for a total of 12 infusions over 24 weeks. Following Randomization 1, par. not demonstrating PD entered Randomization 2 (OFA Extended or OFA Observation); or par. entered Survival Follow-up (SFU) if demonstrating progressive disease (PD). During Randomization 2, par. either received another 24 weeks of OFA 2000 mg every 4 weeks (OFA Extension) or received no further treatment (trt) (OFA Observation). Par. entered Follow-up until withdrawal or the end of study (60 months). Par only entered SFU if demonstrating PD during the study. Only the survival status and anti-cancer therapy information was collected in the SFU.
823904|NCT01313676|B5|Baseline|Total|Total of all reporting groups
823905|NCT01313676|B4|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823906|NCT01313676|B3|Baseline|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823907|NCT01313676|B2|Baseline|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823908|NCT01313676|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823909|NCT01313676|P4|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg|Participants received FF/VI 100/25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823910|NCT01313676|P3|Participant Flow|Vilanterol 25 µg|Participants received Vilanterol (VI) 25 µg inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823911|NCT01313676|P2|Participant Flow|Fluticasone Furoate 100 µg|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the morning from the DPI until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823912|NCT01313676|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) until the required number of events (death) was achieved. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
823981|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
823930|NCT01313663|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823931|NCT01313663|B1|Baseline|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823932|NCT01313663|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823933|NCT01313663|P1|Participant Flow|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823934|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823935|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823936|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823937|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823938|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823939|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823982|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823940|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823941|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823942|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823943|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823944|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823945|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823946|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823947|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823948|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823949|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823950|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823951|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823952|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823953|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823954|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823983|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
823955|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823956|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823957|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823958|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823959|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
824014|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
823960|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823961|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823962|NCT01313663|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823963|NCT01313663|O1|Outcome|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823964|NCT01313663|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) orally once a day at approximately the same time each day, either 1 hour before a meal or 2 hours after a meal. The tablets were to be swallowed whole and were not to be crushed or broken. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823965|NCT01313663|E1|Reported Event|Pemetrexed 500 mg/m^2|Participants received an intravenous (IV) infusion of pemetrexed (500 mg per meters squared [mg/m^2]) over 10 minutes on Day 1 of each 21-day cycle. Participants received study treatment until disease progression, death, unacceptable adverse event, withdrawal of consent, or physician decision. Participants who withdrew due to an adverse event or disease progression were followed for survival.
823966|NCT01313650|B5|Baseline|Total|Total of all reporting groups
823967|NCT01313650|B4|Baseline|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
823968|NCT01313650|B3|Baseline|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
823969|NCT01313650|B2|Baseline|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
823970|NCT01313650|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823971|NCT01313650|P4|Participant Flow|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
823972|NCT01313650|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
823973|NCT01313650|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) QD via a DPI in the morning for 24 weeks.
823974|NCT01313650|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
823975|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
823976|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
823977|NCT01313650|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg QD via a DPI in the morning for 24 weeks.
823978|NCT01313650|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
823979|NCT01313650|O4|Outcome|UMEC/VI 62.5/25 µg QD|Participants received UMEC/VI 62.5/25 µg QD via a DPI in the morning for 24 weeks.
823980|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
823984|NCT01313650|O3|Outcome|VI 25 µg QD|Participants received VI 25 µg QD via a DPI for 24 weeks.
823998|NCT01313637|B2|Baseline|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
823999|NCT01313637|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
824000|NCT01313637|P4|Participant Flow|UMEC/VI 125/25 µg QD|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
824001|NCT01313637|P3|Participant Flow|VI 25 µg QD|Participants received vilanterol (VI) 25 µg QD via a DPI for 24 weeks.
824002|NCT01313637|P2|Participant Flow|UMEC 125 µg QD|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD via a DPI in the morning for 24 weeks.
824003|NCT01313637|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 24 weeks.
824004|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
824005|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
824006|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
824007|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
824008|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
824009|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
824010|NCT01313637|O2|Outcome|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
824011|NCT01313637|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
824012|NCT01313637|O4|Outcome|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
824013|NCT01313637|O3|Outcome|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
824020|NCT01313637|E4|Reported Event|UMEC/VI 125/25 µg|Participants received UMEC/VI 125/25 µg QD via a DPI in the morning for 24 weeks.
824021|NCT01313637|E3|Reported Event|VI 25 µg|Participants received VI 25 µg QD via a DPI for 24 weeks.
824022|NCT01313637|E2|Reported Event|UMEC 125 µg|Participants received UMEC 125 µg QD via a DPI in the morning for 24 weeks.
824023|NCT01313637|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 24 weeks.
824024|NCT01313624|B3|Baseline|Total|Total of all reporting groups
824025|NCT01313624|B2|Baseline|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle each followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824026|NCT01313624|B1|Baseline|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824027|NCT01313624|P2|Participant Flow|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824028|NCT01313624|P1|Participant Flow|AZLI-AZLI|Participants were randomized to receive blinded Aztreonam for Inhalation Solution (AZLI) 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824029|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824030|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824031|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824032|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824033|NCT01313624|O2|Outcome|Placebo-AZLI|Participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824034|NCT01313624|O1|Outcome|AZLI-AZLI|Participants were randomized to receive blinded AZLI 75 mg three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824086|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824035|NCT01313624|E4|Reported Event|Placebo-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824036|NCT01313624|E3|Reported Event|AZLI-AZLI (Open-Label)|Adverse events for this reporting group were reported from Day 112 to Day 196 plus 30 days while participants were receiving open-label AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824037|NCT01313624|E2|Reported Event|Placebo-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind placebo; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824038|NCT01313624|E1|Reported Event|AZLI-AZLI (Double-Blind)|Adverse events for this reporting group were reported from baseline to Day 112 while participants were receiving double-blind AZLI; participants were randomized to receive blinded placebo to match AZLI three times daily via investigational nebulizer for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI 75 mg three times daily for 28 days plus 56 days of treatment-free follow-up.
824039|NCT01313520|B3|Baseline|Total|Total of all reporting groups
824040|NCT01313520|B2|Baseline|Placebo|saline via intravenous infusion
824041|NCT01313520|B1|Baseline|Infliximab|3 mg/kg of Infliximab intravenous infusion
824042|NCT01313520|P2|Participant Flow|Placebo|saline via intravenous infusion
824043|NCT01313520|P1|Participant Flow|Infliximab|3 mg/kg of Infliximab intravenous infusion
824044|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
824045|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
824046|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
824047|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
824048|NCT01313520|O2|Outcome|Placebo|Saline via intravenous infusion
824049|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab via intravenous infusion
824055|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
824056|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
824057|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
824058|NCT01313520|O2|Outcome|Placebo|saline via intravenous infusion
824059|NCT01313520|O1|Outcome|Infliximab|3 mg/kg of Infliximab intravenous infusion
824060|NCT01313520|E2|Reported Event|Placebo|saline via intravenous infusion
824061|NCT01313520|E1|Reported Event|Infliximab|3 mg/kg of Infliximab intravenous infusion
824062|NCT01313507|B1|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
824063|NCT01313507|P1|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
824064|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
824065|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
824066|NCT01313507|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
824067|NCT01313507|E1|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 or 4 weeks for 3 months (5 or 4 total infusions, respectively).
824068|NCT01313494|B3|Baseline|Total|Total of all reporting groups
824069|NCT01313494|B2|Baseline|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824070|NCT01313494|B1|Baseline|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824071|NCT01313494|P2|Participant Flow|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824072|NCT01313494|P1|Participant Flow|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824073|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824074|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824075|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824076|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824077|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824078|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824079|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824080|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824081|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824082|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824083|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824084|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824088|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824089|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824090|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824091|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824092|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824093|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824094|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824095|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824096|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824097|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824098|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824099|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824100|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824101|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824102|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824103|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824104|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824105|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824106|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824107|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824108|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824109|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824110|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824111|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824112|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824113|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824114|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824115|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824116|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824117|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824118|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824119|NCT01313494|O2|Outcome|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824120|NCT01313494|O1|Outcome|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824121|NCT01313494|E2|Reported Event|Placebo|Placebo to roflumilast, tablet, oral, once daily for up to 24 weeks.
824122|NCT01313494|E1|Reported Event|Roflumilast|Roflumilast 500 μg, tablet, oral, once daily for up to 24 weeks.
824123|NCT01313312|B1|Baseline|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824124|NCT01313312|P1|Participant Flow|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 intramuscular (i.m.) injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824125|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824178|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
824126|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824127|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824128|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824207|NCT01313221|P1|Participant Flow|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824208|NCT01313221|O2|Outcome|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
824366|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
824129|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824130|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824131|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824132|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824179|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
824180|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
824181|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
824182|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
824183|NCT01313299|E3|Reported Event|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
824133|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824134|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824135|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824136|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824137|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824138|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824139|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824184|NCT01313299|E2|Reported Event|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
824185|NCT01313299|E1|Reported Event|Placebo|Placebo intramuscular injection single treatment cycle on day 1
824186|NCT01313273|B3|Baseline|Total|Total of all reporting groups
824187|NCT01313273|B2|Baseline|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824140|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824141|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824142|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824143|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824144|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824145|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824146|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824188|NCT01313273|B1|Baseline|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824189|NCT01313273|P2|Participant Flow|Arm B: Lanreotide + Non Steroidal Anti Androgens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non steroidal anti androgens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824293|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824147|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824148|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824149|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824150|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824151|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824152|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824153|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824190|NCT01313273|P1|Participant Flow|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal anti androgens (e.g. bicalutamide 50 mg/day) plus Luteinizing Hormone-Releasing Hormone Analogues (LHRH-a) (e.g. triptorelin 3.75 mg/month) till progression.
824191|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824405|NCT01312948|O2|Outcome|Usual Mask|Usability (overall performance) score of the child's usual CPAP mask
824154|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824155|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824156|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824157|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824158|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824159|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824160|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824192|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824193|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824194|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824161|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824162|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824163|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824164|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824165|NCT01313312|O1|Outcome|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824166|NCT01313312|E1|Reported Event|Total Dysport®|"A total of 254 subjects in the open label study received between 1 and 5 i.m. injections of Dysport® according to their individual needs, for a period of up to 12 months.~All subjects were administered an appropriate dosage of Dysport® (1000 U or 500 U) on Day 1 of treatment Cycle 1. At each study visit from Week 12 onwards, subjects were assessed to determine whether a subsequent treatment cycle was required and treatment cycles were administered at intervals of a minimum of 12 weeks apart depending on the subject’s safety and efficacy response.~From Cycle 2 onwards, a total dose of 1500 U could be administered in subjects requiring treatment with Dysport® in their shoulder and other upper limb muscles. Subjects who showed improvement in their upper limb during the first two treatment cycles were able to receive concomitant injections of Dysport® 500 U into at least one calf muscle, from Cycle 3 onwards as long as the total dose did not exceed 1500 U."
824167|NCT01313299|B4|Baseline|Total|Total of all reporting groups
824168|NCT01313299|B3|Baseline|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
824169|NCT01313299|B2|Baseline|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
824170|NCT01313299|B1|Baseline|Placebo|Placebo intramuscular injection single treatment cycle on day 1
824171|NCT01313299|P3|Participant Flow|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
824172|NCT01313299|P2|Participant Flow|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
824173|NCT01313299|P1|Participant Flow|Placebo|Placebo intramuscular injection single treatment cycle on day 1
824174|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
824175|NCT01313299|O2|Outcome|Dysport 500 U|Botulinum type A toxin (Dysport) 500 U intramuscular injection single treatment cycle on day 1
824176|NCT01313299|O1|Outcome|Placebo|Placebo intramuscular injection single treatment cycle on day 1
824177|NCT01313299|O3|Outcome|Dysport 1000 U|Botulinum type A toxin (Dysport) 1000 U intramuscular injection single treatment cycle on day 1
825161|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
824195|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824196|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824197|NCT01313273|O2|Outcome|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824198|NCT01313273|O1|Outcome|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824199|NCT01313273|E2|Reported Event|Arm B: Lanreotide + Non-steroidal Antiandrogens and LHRH-a|Lanreotide 120 mg injection every 28 days till progression or for a maximum of 24 months plus non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) and LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824200|NCT01313273|E1|Reported Event|Arm A: Non-steroidal Anti Androgens + LHRH-a|Non-steroidal antiandrogens (e.g. bicalutamide 50 mg/day) plus LHRH-a (e.g. triptorelin 3.75 mg/month) till progression.
824201|NCT01313221|B4|Baseline|Total|Total of all reporting groups
824202|NCT01313221|B3|Baseline|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
824203|NCT01313221|B2|Baseline|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824204|NCT01313221|B1|Baseline|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824205|NCT01313221|P3|Participant Flow|Non-randomized|Enrolled participants received etanercept 50 mg twice weekly but discontinued prior to completing the 12-week open-label treatment period.
824206|NCT01313221|P2|Participant Flow|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824344|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
824209|NCT01313221|O1|Outcome|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
824210|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824211|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824212|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824213|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824214|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824215|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824216|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824217|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824218|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824219|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824220|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824221|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824222|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824223|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824224|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824225|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824226|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
825162|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
824227|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824228|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824229|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824230|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824231|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824232|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824233|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824234|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824235|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824236|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824237|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824238|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824239|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824365|NCT01313078|O1|Outcome|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
824240|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824241|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824242|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824243|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824244|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824245|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824246|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824247|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824248|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824249|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824250|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824251|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824252|NCT01313221|O2|Outcome|Etanercept 50 mg QW + Topical|Following 12 weeks of etanercept 50 mg twice weekly, participants were randomized to 50 mg subcutaneous injection once weekly (QW) plus as needed topical agents.
824253|NCT01313221|O1|Outcome|Etanercept 50 mg BIW|Following 12 weeks of etanercept 50 mg twice weekly (BIW), participants were randomized to 50 mg etanercept by subcutaneous injection twice weekly for 12 weeks.
824254|NCT01313221|E2|Reported Event|Etanercept + Topical|All participants who used a topical agent at least once during the study, regardless of treatment group assignment.
824255|NCT01313221|E1|Reported Event|Etanercept Monotherapy|All participants who received etanercept at any time during the study, who never used a topical agent, regardless of treatment assignment, including those participants who were not randomized at Week 12.
824256|NCT01313208|B3|Baseline|Total|Total of all reporting groups
824257|NCT01313208|B2|Baseline|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
824258|NCT01313208|B1|Baseline|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
824259|NCT01313208|P2|Participant Flow|Etanercept|"Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks.~All participants continued their DMARD treatment throughout the 24-week study period."
824260|NCT01313208|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
824261|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824262|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824263|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824264|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824265|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824266|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824267|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824268|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824269|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824270|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824271|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824272|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824273|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824274|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824275|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824276|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824277|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824278|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824279|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824280|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824281|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824282|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824283|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824284|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824285|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824286|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824287|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824288|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824289|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824290|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824291|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824292|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
825163|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
824294|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824295|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824296|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824297|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824298|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824299|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824300|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824301|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824302|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824303|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824304|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824305|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824306|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824307|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824308|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824309|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824310|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824311|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824312|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824313|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824314|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824315|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824316|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824317|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824318|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824319|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824320|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824321|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824322|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824323|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824324|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824325|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824326|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824327|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824328|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824406|NCT01312948|O1|Outcome|Pixi Paediatric Mask Usability|Usability (overall performance) score of the Pixi paediatric mask
824329|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824330|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824331|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824332|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824333|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824334|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824335|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824336|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824337|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824338|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824339|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then etanercept 50 mg once weekly for the next 12 weeks.
824340|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks and then etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks.
824341|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
824342|NCT01313208|O1|Outcome|Placebo|Participants received placebo subcutaneous injections once a week for 12 weeks.
824343|NCT01313208|O2|Outcome|Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks.
824345|NCT01313208|E2|Reported Event|Etanercept-Etanercept|Participants received etanercept 50 mg subcutaneous injection once weekly for 12 weeks and then open-label etanercept 50 mg subcutaneous injection for the next 12 weeks. All participants continued their DMARD treatment throughout the 24-week study period.
824346|NCT01313208|E1|Reported Event|Placebo-Etanercept|Participants received placebo subcutaneous injections once a week for 12 weeks and then open-label etanercept 50 mg subcutaneous injection once weekly for the next 12 weeks. All participants continued their disease modifying anti-rheumatic drug (DMARD) treatment throughout the 24-week study period.
824347|NCT01313182|B3|Baseline|Total|Total of all reporting groups
824348|NCT01313182|B2|Baseline|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
824349|NCT01313182|B1|Baseline|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
824350|NCT01313182|P2|Participant Flow|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
824351|NCT01313182|P1|Participant Flow|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
824352|NCT01313182|O2|Outcome|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
824353|NCT01313182|O1|Outcome|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
824354|NCT01313182|E2|Reported Event|Bactroban Nasal|"Mupirocin calcium ointment, 2%~mupirocin calcium ointment, 2%: Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
824407|NCT01312948|E1|Reported Event|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
824355|NCT01313182|E1|Reported Event|3M Skin and Nasal Antiseptic|"Povidone-iodine solution 5% w/w (0.5% available iodine) USP Patient Preoperative Skin Preparation~Povidone-iodine solution 5% w/w (0.5% available iodine) Patient Preoperative Skin Preparation: The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds."
824356|NCT01313117|B1|Baseline|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
824357|NCT01313117|P1|Participant Flow|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
824358|NCT01313117|O1|Outcome|Alpha Lipoic Acid|The study was designed to first explore the optimal ALA dose. The baseline dose was 100 mg three times daily for four months. Dose escalation was to occur until a maximum tolerated dose (MTD) was found. Once the MTD was established we were then to enroll additional patients at the MTD for efficacy analysis. The study failed to reach the MTD. Only small numbers of patients were enrolled. As such, we were unable to perform any meaningful efficacy (TNS) analysis.
824359|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
824360|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
824361|NCT01313117|O1|Outcome|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
824362|NCT01313117|E1|Reported Event|Alpha Lipoic Acid|"Oral administration three times daily (morning, mid-day, night)~Alpha lipoic acid: The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found."
824363|NCT01313078|B1|Baseline|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
824364|NCT01313078|P1|Participant Flow|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
824367|NCT01313078|E1|Reported Event|Pegaspargase in Women With Cancer|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
824368|NCT01313039|B1|Baseline|AZD6244|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
824369|NCT01313039|P1|Participant Flow|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
824370|NCT01313039|O1|Outcome|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
824371|NCT01313039|E1|Reported Event|Single Arm|AZ6244: AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
824372|NCT01312961|B3|Baseline|Total|Total of all reporting groups
824373|NCT01312961|B2|Baseline|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824374|NCT01312961|B1|Baseline|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
824375|NCT01312961|P2|Participant Flow|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824376|NCT01312961|P1|Participant Flow|Placebo (for Dupilumab)|Placebo (for Dupilumab) subcutaneous (SC) injection once weekly (qw) for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol were given as rescue medication.
824377|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824378|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824379|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824380|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824381|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824382|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824383|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824384|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824385|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824386|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824387|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824388|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824389|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824390|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824391|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824392|NCT01312961|O1|Outcome|Placebo|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824393|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824394|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824395|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824396|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824397|NCT01312961|O2|Outcome|Dupilumab 300 mg qw|Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824398|NCT01312961|O1|Outcome|Placebo (for Dupilumab)|Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (Fluticasone/Salmeterol combination therapy at stable dose for 4 weeks followed by Fluticasone monotherapy, dose progressively decreased and discontinued at Week 9). Albuterol or Levalbuterol was given as rescue medication.
824399|NCT01312961|E2|Reported Event|Dupilumab 300 mg qw|Participants exposed to Dupilumab 300 mg SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
824400|NCT01312961|E1|Reported Event|Placebo (for Dupilumab)|Participants exposed to Placebo (for Dupilumab) SC injection qw for 12 weeks added to background therapy of ICS/LABA (mean exposure of 11 weeks).
824401|NCT01312948|B1|Baseline|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
824402|NCT01312948|P1|Participant Flow|Prototype Mask|New paediatric mask system (Pixi) designed for children aged 2-7 years using Positive airway pressure (PAP) therapy
824403|NCT01312948|O2|Outcome|Usual Mask|Apnea hypopnoea index from a monitored sleep study of the child's usual CPAP mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
824404|NCT01312948|O1|Outcome|Pixi Paediatric Mask|Apnea hypopnoea index from a monitored sleep study of the new Pixi mask. An apnea hypopnoea index of <5 demonstrates treatment efficacy
824409|NCT01312844|B2|Baseline|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824410|NCT01312844|B1|Baseline|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824411|NCT01312844|P2|Participant Flow|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824412|NCT01312844|P1|Participant Flow|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824413|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824414|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824415|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824416|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824417|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824418|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824419|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824420|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824421|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824422|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824423|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824424|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824425|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824426|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824427|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824428|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824429|NCT01312844|O2|Outcome|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824430|NCT01312844|O1|Outcome|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824431|NCT01312844|E2|Reported Event|Placebo|"Patients receiving IV placebo at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824432|NCT01312844|E1|Reported Event|Scopolamine|"Patients receiving IV scopolamine at ECT treatment~Scopolamine: Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT"
824433|NCT01312818|B1|Baseline|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
824434|NCT01312818|P1|Participant Flow|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
824465|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824466|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824467|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824468|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824435|NCT01312818|O1|Outcome|Chemotherapy|"Bortezomib IV Vorinostat PO Dexamethasone PO Intrathecal Methotrexate Imatinib Mesylate PO (for Ph+ ALL patients only)~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
824436|NCT01312818|O1|Outcome|ALL Treated Patients|"List of toxicities in acute lymphoblastic leukemia (ALL) patients treated with bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
824437|NCT01312818|O1|Outcome|ALL Treated Patients|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
824438|NCT01312818|E1|Reported Event|Chemotherapy|"bortezomib, vorinostat and dexamethasone combination, as well as intrathecal methotrexate and imatinib mesylate.~Bortezomib: 1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.~Vorinostat: 180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14~Dexamethasone: 6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.~Methotrexate: Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)~Imatinib mesylate: For Ph+ acute lymphoblastic leukemia (ALL) patients only:~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
824439|NCT01312805|B3|Baseline|Total|Total of all reporting groups
824440|NCT01312805|B2|Baseline|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
824441|NCT01312805|B1|Baseline|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
824442|NCT01312805|P2|Participant Flow|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
824443|NCT01312805|P1|Participant Flow|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
824444|NCT01312805|O2|Outcome|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
824445|NCT01312805|O1|Outcome|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
824446|NCT01312805|E2|Reported Event|CHICA Asthma Module|"This arm received the CHICA asthma module~CHICA Asthma Module: This module was added to CHICA to help diagnose and manage asthma"
824447|NCT01312805|E1|Reported Event|CHICA Control|"This arm received CHICA without the asthma module~CHICA Control: This is CHICA without the asthma module, and was used as a control"
824448|NCT01312766|B3|Baseline|Total|Total of all reporting groups
824449|NCT01312766|B2|Baseline|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824450|NCT01312766|B1|Baseline|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824451|NCT01312766|P2|Participant Flow|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824452|NCT01312766|P1|Participant Flow|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824453|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824454|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824455|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824456|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824457|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824458|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824459|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824460|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824461|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824462|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824463|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824464|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
825164|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
824469|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824470|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824471|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824472|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824473|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824474|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824475|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824476|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824477|NCT01312766|O2|Outcome|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824478|NCT01312766|O1|Outcome|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824479|NCT01312766|E2|Reported Event|Menopur|Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
824480|NCT01312766|E1|Reported Event|hMG-IBSA|"New hMG preparation.~Menotropins: Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age."
824481|NCT01312519|B3|Baseline|Total|Total of all reporting groups
824482|NCT01312519|B2|Baseline|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
824483|NCT01312519|B1|Baseline|Manual Bone Marrow Sampling Device|Hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
824484|NCT01312519|P2|Participant Flow|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
824485|NCT01312519|P1|Participant Flow|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
824486|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
824487|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
824488|NCT01312519|O2|Outcome|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
824489|NCT01312519|O1|Outcome|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
824490|NCT01312519|E2|Reported Event|OnControl Bone Marrow System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest.
824491|NCT01312519|E1|Reported Event|Manual Bone Marrow Sampling Device|hollow needle with a t-shaped handle manually pushed into the bone for the purpose of bone marrow aspiration and core biopsy collection.
824492|NCT01312467|B1|Baseline|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
824493|NCT01312467|P1|Participant Flow|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
824494|NCT01312467|O1|Outcome|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
824495|NCT01312467|E1|Reported Event|Prevention (Metformin Hydrochloride)|"Patients receive metformin hydrochloride PO QD during week 1 and then BID during weeks 2-12. Treatment continues for 12 weeks in the absence of disease progression or unacceptable toxicity.~metformin hydrochloride: Given PO~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
824496|NCT01312428|B3|Baseline|Total|Total of all reporting groups
824497|NCT01312428|B2|Baseline|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
824498|NCT01312428|B1|Baseline|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
824499|NCT01312428|P2|Participant Flow|No PAL (No Pelvic Alignment Level)|"The cases randomized into the No PAL Group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
824500|NCT01312428|P1|Participant Flow|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL Group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
824501|NCT01312428|O2|Outcome|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
824502|NCT01312428|O1|Outcome|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
824503|NCT01312428|E2|Reported Event|No PAL (No Pelvic Alignment Level)|"The cases randomized into the no PAL group will have total hip replacement surgery performed without the use of the PAL instrument. This group will serve as the control group.~Total Hip Replacement: Total hip replacement surgery will be performed without utilizing the PAL Instrument."
824504|NCT01312428|E1|Reported Event|PAL (Pelvic Alignment Level)|"The cases randomized into the PAL group will have total hip replacement surgery performed utilizing the PAL instrument.~Pelvic Alignment Level (PAL) Instrument: Total hip replacement surgery will be performed utilizing the PAL Instrument."
824505|NCT01312272|B3|Baseline|Total|Total of all reporting groups
824506|NCT01312272|B2|Baseline|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824507|NCT01312272|B1|Baseline|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824508|NCT01312272|P2|Participant Flow|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824509|NCT01312272|P1|Participant Flow|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824510|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824649|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824511|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824512|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824513|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824514|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824515|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824516|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824517|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824518|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824519|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824520|NCT01312272|O2|Outcome|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
825165|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
824521|NCT01312272|O1|Outcome|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824522|NCT01312272|E2|Reported Event|Intranasal Oxytocin|"Oxytocin nasal spray (40 units/ml) will be administered in a single intranasal dose of 40 IU. Its formula is: oxytocin 1 unit/mg mannitol trituration 0.2Gm + glycerin USP 0.1ml + preserved water 5ml.~Oxytocin: Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time"
824523|NCT01312272|E1|Reported Event|Inactive Nasal Spray|"A placebo nasal spray will be prepared to be otherwise identical to the active treatment nasal spray except lacking oxytocin. The ingredients in the inactive nasal spray are mannitol, glycerin, and preserved water.~Inactive placebo nasal spray: A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time."
824524|NCT01312129|B3|Baseline|Total|Total of all reporting groups
824525|NCT01312129|B2|Baseline|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
824526|NCT01312129|B1|Baseline|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
824527|NCT01312129|P2|Participant Flow|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
824528|NCT01312129|P1|Participant Flow|Placebo First, Then Sulfasalzine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
824529|NCT01312129|O2|Outcome|Sulfasalazine|Sulfasalazine capsule, 500mg, x 3 doses 12 hours.
824530|NCT01312129|O1|Outcome|Placebo|Placebo x 3 doses 12 hours apart
824531|NCT01312129|E2|Reported Event|Sulfasalazine First, Then Placebo|Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the first session (Sulfasalazine 1500mg total) followed by a washout period of 7 days, then Placebo capsule x 3 doses 12 hours apart in the second session.
824532|NCT01312129|E1|Reported Event|Placebo First, Then Sulfasalazine|Placebo x 3 doses 12 hours apart in the first session, followed by a washout period of 7 days, then Sulfasalazine capsule, 500mg, x 3 doses 12 hours apart in the second session (Sulfasalazine 1500mg total)
824533|NCT01312038|B3|Baseline|Total|Total of all reporting groups
824534|NCT01312038|B2|Baseline|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
824535|NCT01312038|B1|Baseline|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
824536|NCT01312038|P2|Participant Flow|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
824537|NCT01312038|P1|Participant Flow|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
824538|NCT01312038|O2|Outcome|Placebo|Outcome measure in each evaluable ear
824539|NCT01312038|O1|Outcome|Simethicone-treated|Outcome measure in each evaluable ear.
824540|NCT01312038|E2|Reported Event|Placebo|"chewable calcium tablet~Placebo: chewable calcium tablet"
824541|NCT01312038|E1|Reported Event|Simethicone|"125 mg tablet~Simethicone: single 125 mg chewable tablet"
824542|NCT01310855|B3|Baseline|Total|Total of all reporting groups
824543|NCT01310855|B2|Baseline|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
824544|NCT01310855|B1|Baseline|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
824545|NCT01310855|P2|Participant Flow|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
824546|NCT01310855|P1|Participant Flow|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
824547|NCT01310855|O2|Outcome|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~Placebo"
824548|NCT01310855|O1|Outcome|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~cediranib maleate~gefitinib"
824570|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824549|NCT01310855|E2|Reported Event|Cediranbib & Placebo|"Cediranib maleate 30mg od orally and placebo 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited."
824550|NCT01310855|E1|Reported Event|Cediranib & Gefitinib|"Cediranib maleate 30mg od orally and gefitinib 500mg od orally. Each cycle of treatment lasts 6 weeks. Treatment will continue until confirmation of progression, patient decision or the development of unacceptable toxicity (if there is radiological progression only treatment can continue if the investigator has the opinion that the patient is receiving benefit.~Due to the early discontinuation of Cediranib by AZ, the trial was discontinued early so that only 38 patients (19 per arm) were recruited. One patient in the Cediranib arm did not complete their patient diary, and it was not known how much of the trial treatment they had. Therefore the adverse events reported by the patient could not be attributed to the trial treatment and they were excluded from all analyses."
824551|NCT01311687|B3|Baseline|Total|Total of all reporting groups
824552|NCT01311687|B2|Baseline|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824553|NCT01311687|B1|Baseline|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824554|NCT01311687|P2|Participant Flow|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824555|NCT01311687|P1|Participant Flow|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824556|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824557|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824558|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824559|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824560|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824561|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824562|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824563|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824564|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824565|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824566|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824567|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824568|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824569|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
825166|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
824571|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824572|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824573|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824574|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824575|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824576|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824577|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824578|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824579|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824580|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824581|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824582|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824583|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824584|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824585|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824586|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824587|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824588|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824589|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824590|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824591|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824592|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824626|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824593|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824594|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824595|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824596|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824597|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824598|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824599|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824600|NCT01311687|O2|Outcome|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824601|NCT01311687|O1|Outcome|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824602|NCT01311687|E2|Reported Event|High-Dose Dexamethasone|Participants received 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1 through 4, 9 through 12, and 17 through 20 of a 28-day cycle until disease progression.
824603|NCT01311687|E1|Reported Event|Pomalidomide Plus Low-Dose Dexamethasone|Participants received 4 mg pomalidomide administered by mouth on Days 1-21 of each 28-day treatment cycle and 40 mg dexamethasone (participants > 75 years of age received 20 mg dexamethasone) administered by mouth once per day on Days 1, 8, 15, and 22 of a 28-day cycle until disease progression.
824604|NCT01311661|B1|Baseline|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
824605|NCT01311661|P1|Participant Flow|Study Total|This was a double-blind, 3-period crossover trial. 206 patients were assigned randomly to one of 12 treatment sequences with either 5 microgram (mcg) Olodaterol (Olo) once daily (qd) and 2.5 mcg Olodaterol twice daily (bid) and placebo (6 sequences) or 10 mcg Olodaterol qd and 5 mcg Olodaterol bid and placebo (6 sequences). The duration of each treatment period was 3 weeks separated by washout periods of 2 weeks.
824606|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824607|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824608|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824609|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824610|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824611|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824612|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824613|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824614|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824615|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824616|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824617|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824618|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824619|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824620|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824621|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824622|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824623|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824624|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824625|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824628|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824629|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824630|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824631|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824632|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824633|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824634|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824635|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824636|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824637|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824638|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824639|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824640|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824641|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824642|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824643|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824644|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824645|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824646|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824647|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824648|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824650|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824651|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824652|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824653|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824654|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824655|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824656|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824657|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824658|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824659|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824660|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824661|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824662|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824663|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824664|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824665|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824666|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824667|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824668|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824669|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824670|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824671|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824672|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824673|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824674|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824675|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824676|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824677|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824678|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824679|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
825167|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
824680|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824681|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824682|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824683|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824684|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824685|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824686|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824687|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824688|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824689|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824690|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824691|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824692|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824693|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824694|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824695|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824696|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824697|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824698|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824699|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824700|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824701|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824702|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824703|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824704|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824705|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824706|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824707|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824708|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824709|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824710|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824711|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824712|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824713|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824714|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824715|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824716|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824717|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824718|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824719|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824720|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824721|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824722|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824723|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824724|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824725|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824726|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824727|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824728|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824729|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824730|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824731|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
825168|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
824733|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824734|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824735|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824736|NCT01311661|O5|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824737|NCT01311661|O4|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824738|NCT01311661|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824739|NCT01311661|O2|Outcome|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824740|NCT01311661|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824741|NCT01311661|E5|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824742|NCT01311661|E4|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
824743|NCT01311661|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) and matching Placebo in the evening delivered by the Respimat Inhaler.
824744|NCT01311661|E2|Reported Event|Olo 2.5 mcg Bid|Olodaterol 2.5 mcg bid delivered by the Respimat Inhaler.
824745|NCT01311661|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler. Two actuations bid (morning and evening dosing).
824746|NCT01311557|B3|Baseline|Total|Total of all reporting groups
824747|NCT01311557|B2|Baseline|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824748|NCT01311557|B1|Baseline|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824749|NCT01311557|P2|Participant Flow|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824750|NCT01311557|P1|Participant Flow|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824751|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824752|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824753|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824754|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824755|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824756|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824757|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824758|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824759|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824760|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824761|NCT01311557|O2|Outcome|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824762|NCT01311557|O1|Outcome|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824763|NCT01311557|E2|Reported Event|Participants 11 to <12 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824764|NCT01311557|E1|Reported Event|Participants 10 to <11 Years of Age|Participants received 1 dose of Adacel® vaccine at Visit 1.
824765|NCT01311505|B1|Baseline|Participants Eligible for Analysis|Includes participants randomized to receive Myrin 2 first and Rimactane first and who had completed the study. It excludes 1 participant who did not meet the weight requirement for the study (protocol violator).
824766|NCT01311505|P2|Participant Flow|Rimactane First, Then Myrin 2|Single oral dose of Rimactane capsule (300 mg rifampicin) in first intervention period; and single oral dose of 2 FDC tablets of Myrin 2 (each tablet contains 150 mg rifampicin and 75 mg isoniazid) in second intervention period. A washout period of at least 7 days was maintained between each period.
824767|NCT01311505|P1|Participant Flow|Myrin 2 First, Then Rimactane|Single oral dose of 2 fixed dose combination (FDC) tablets of Myrin 2 (each tablet contains 150 milligram (mg) rifampicin and 75 mg isoniazid) in first intervention period, and single oral dose of Rimactane capsule (300 mg rifampicin) in second intervention period. A washout period of at least 7 days was maintained between each period.
824768|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
824769|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
824770|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
824771|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
824772|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
824773|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
824774|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
824775|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
824776|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
824777|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
824778|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
824779|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
824780|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
824781|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
824782|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
824783|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
824784|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
824785|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
824786|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
824787|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
824788|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg capsule) in either first intervention period or second intervention period.
824789|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
824790|NCT01311505|O2|Outcome|Rimactane|Single oral dose of reference drug Rimactane capsule (300 mg rifampicin) in either first intervention period or second intervention period.
824791|NCT01311505|O1|Outcome|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 mg rifampicin and 75 mg isoniazid.
824792|NCT01311505|E2|Reported Event|Rimactane|Single oral dose of reference drug Rimactane 300 mg capsule in either first intervention period or second intervention period.
824793|NCT01311505|E1|Reported Event|Myrin 2|Single oral dose of 2 FDC tablets of Myrin 2 (Test) in either first intervention period or second intervention period. Each tablet contains 150 rifampicin and 75 mg isoniazid.
824794|NCT01311362|B1|Baseline|Ambrisentan|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
824795|NCT01311362|P1|Participant Flow|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose administration of ambrisentan 5 mg p.o. q.d. on day 3-10 administration of ambrisentan 5 mg p.o. q.d on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
824796|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
824797|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
824798|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
824799|NCT01311362|O3|Outcome|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg t.i.d. on day 11-20
824800|NCT01311362|O2|Outcome|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
824801|NCT01311362|O1|Outcome|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
824802|NCT01311362|E3|Reported Event|Ambrisentan During St John's Wort|administration of ambrisentan 5 mg p.o. q.d. on day 11-20 and administration of SJW 300 mg p.o. t.i.d. on day 11-20
824803|NCT01311362|E2|Reported Event|Ambrisentan at Steady-state|administration of ambrisentan 5 mg p.o. q.d. on day 3-10
824804|NCT01311362|E1|Reported Event|Ambrisentan After First Dose|administration of ambrisentan 5 mg p.o. single dose
824805|NCT01311102|B3|Baseline|Total|Total of all reporting groups
824806|NCT01311102|B2|Baseline|Normal Saline|Normal Saline : 1.33cc of normal saline
824807|NCT01311102|B1|Baseline|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
824808|NCT01311102|P2|Participant Flow|Normal Saline|Normal Saline : 1.33cc of normal saline
824809|NCT01311102|P1|Participant Flow|Lidocaine|Lidocaine : 1.33 cc of 2% liquid lidocaine
824810|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline infused in endo cervix and endometrium.
824811|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine infused in endo cervix and endometrium
824812|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
824813|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
824814|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
824815|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
824816|NCT01311102|O2|Outcome|Normal Saline|Normal Saline : 1.33cc of normal saline
824817|NCT01311102|O1|Outcome|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
824818|NCT01311102|E2|Reported Event|Normal Saline|Normal Saline : 1.33cc of normal saline
824819|NCT01311102|E1|Reported Event|Lidocaine|Lidocaine : 1.33cc of 2% liquid lidocaine
824820|NCT01311024|B3|Baseline|Total|Total of all reporting groups
825169|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825170|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
824821|NCT01311024|B2|Baseline|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
824822|NCT01311024|B1|Baseline|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)"
824823|NCT01311024|P2|Participant Flow|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
824824|NCT01311024|P1|Participant Flow|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
824825|NCT01311024|O2|Outcome|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
824854|NCT01310699|B2|Baseline|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
825451|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
824826|NCT01311024|O1|Outcome|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
824827|NCT01311024|E2|Reported Event|Control-vaccinated Sibling|"Older sibling of a child vaccinated with control vaccine (hepatitis B vaccine or hepatitis A vaccine) in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~hepatitis B vaccine or hepatitis A vaccine: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Evaluable subjects with NPS sample analysed 518 Siblings of infant-vaccinated children in the control arms and 271 Siblings of catch-up vaccinated children 789 in total"
824828|NCT01311024|E1|Reported Event|PCV-vaccinated Sibling (GSK1024850A)|"Older sibling of a child vaccinated with PCV in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)~Pneumococcal conjugate vaccine GSK1024850A: 2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380).~Evaluable subjects with NPS sample analysed 482 Siblings of infant-vaccinated children in the PCV 2+1 arm and 445 Siblings of infant-vaccinated children in the PCV 3+1 arm and 568 Siblings of catch-up vaccinated children in the PCV arms 1495 in total"
824829|NCT01310803|B3|Baseline|Total|Total of all reporting groups
824830|NCT01310803|B2|Baseline|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
824831|NCT01310803|B1|Baseline|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
824832|NCT01310803|P2|Participant Flow|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
824833|NCT01310803|P1|Participant Flow|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
824834|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
824835|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
824836|NCT01310803|O2|Outcome|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
824837|NCT01310803|O1|Outcome|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
825171|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825172|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
824838|NCT01310803|E2|Reported Event|No Maintenance (Standard of Care)|"Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy~No Maintenance treatment ( Standard of Care): Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy"
824839|NCT01310803|E1|Reported Event|Maintenance Therapy|"Chemotherapeutic: EN3329-301 (VALSTAR)~VALSTAR - Maintenance Therapy: Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase"
824840|NCT01310777|B4|Baseline|Total|Total of all reporting groups
824841|NCT01310777|B3|Baseline|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
824842|NCT01310777|B2|Baseline|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824843|NCT01310777|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824844|NCT01310777|P3|Participant Flow|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
824845|NCT01310777|P2|Participant Flow|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824846|NCT01310777|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824847|NCT01310777|O3|Outcome|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
824848|NCT01310777|O2|Outcome|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824849|NCT01310777|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824850|NCT01310777|E3|Reported Event|Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye 2 times a day for 6 months
824851|NCT01310777|E2|Reported Event|Brinz|Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824852|NCT01310777|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 2 times a day for 6 months
824853|NCT01310699|B3|Baseline|Total|Total of all reporting groups
825489|NCT01309659|B3|Baseline|Total|Total of all reporting groups
824855|NCT01310699|B1|Baseline|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
824856|NCT01310699|P2|Participant Flow|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
824857|NCT01310699|P1|Participant Flow|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
824858|NCT01310699|O2|Outcome|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
824859|NCT01310699|O1|Outcome|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
824860|NCT01310699|E2|Reported Event|High Definition White Light Colonoscopy|"Use of high definition white light colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
824861|NCT01310699|E1|Reported Event|High Definition NBI Colonoscopy|"Use of high definition narrow band imaging colonoscopy during examination for polyp detection.~Olympus Colonoscope CFHQ190AL: Technically improved colonoscope with close focus high definition narrow band imaging."
824862|NCT01310582|B3|Baseline|Total|Total of all reporting groups
824863|NCT01310582|B2|Baseline|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824864|NCT01310582|B1|Baseline|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824865|NCT01310582|P2|Participant Flow|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824866|NCT01310582|P1|Participant Flow|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824867|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824868|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824869|NCT01310582|O2|Outcome|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
825173|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
824870|NCT01310582|O1|Outcome|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824871|NCT01310582|E2|Reported Event|Sevoflurane|During the surgery the subjects will be given Sevoflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824872|NCT01310582|E1|Reported Event|Desflurane|During the surgery the subjects will be given Desflurane, general anesthesia, that will keep the patient asleep during the surgery. The dosage form is inhalation gas, dosage equivalent to 1 MAC, frequency is once and the duration is throughout the surgery (30-45 minutes).
824873|NCT01310413|B7|Baseline|Total|Total of all reporting groups
824874|NCT01310413|B6|Baseline|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824875|NCT01310413|B5|Baseline|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824876|NCT01310413|B4|Baseline|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824877|NCT01310413|B3|Baseline|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824878|NCT01310413|B2|Baseline|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824879|NCT01310413|B1|Baseline|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824880|NCT01310413|P7|Participant Flow|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824881|NCT01310413|P6|Participant Flow|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824882|NCT01310413|P5|Participant Flow|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824883|NCT01310413|P4|Participant Flow|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824884|NCT01310413|P3|Participant Flow|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825174|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
825175|NCT01308788|E2|Reported Event|Aqueous Suppressant|aqueous suppressant treated
824885|NCT01310413|P2|Participant Flow|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824886|NCT01310413|P1|Participant Flow|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824887|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824939|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825093|NCT01309997|O2|Outcome|Arm II (Monocolonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
825094|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
824888|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824889|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824890|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Virus Monovalent Vaccine Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824891|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824892|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824893|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824894|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824895|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824940|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825095|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
824896|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and PInfluenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824897|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824898|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824899|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824900|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824901|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824936|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825176|NCT01308788|E1|Reported Event|Aqueous Outflow|aqueous outflow treated
825177|NCT01308762|B4|Baseline|Total|Total of all reporting groups
825178|NCT01308762|B3|Baseline|Group 3|IMM-101 1.0 mg
824902|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824903|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824904|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824905|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824906|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824907|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824908|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824909|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&amp;lt;12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&amp;gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824937|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825179|NCT01308762|B2|Baseline|Group 2|IMM-101 0.5 mg
825180|NCT01308762|B1|Baseline|Group 1|IMM-101 0.1 mg
824910|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824911|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824912|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824913|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824914|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824915|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 of was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824916|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824917|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824951|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825181|NCT01308762|P3|Participant Flow|IMM-101 1.0 mg|Patients received an intradermal injection of IMM-101 1.0 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
824918|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824919|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824920|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the PInfluenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824921|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824922|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824923|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824924|NCT01310413|O1|Outcome|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824925|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824952|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825182|NCT01308762|P2|Participant Flow|IMM-101 0.5 mg|Patients received an intradermal injection of IMM-101 0.5 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
824926|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824941|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825096|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
824927|NCT01310413|O1|Outcome|Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824928|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824929|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, PInfluenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824930|NCT01310413|O1|Outcome|Placebo/Placebo/ Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6-<36M, Placebo 3-<9Y or Placebo 9-<18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
824931|NCT01310413|O2|Outcome|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9-<18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824932|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3-<9Y and Influenza A (H5N1) adjuvanted months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824933|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824934|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824935|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824938|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825097|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
824942|NCT01310413|O3|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824943|NCT01310413|O2|Outcome|Influenza A (H5N1) Virus Monovalent Vaccine 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824944|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824945|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824946|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824947|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824948|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824949|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824950|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825244|NCT01309841|E1|Reported Event|NKTR-118 12.5 mg|
824953|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824954|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824955|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825005|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824956|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824957|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824958|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824959|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824960|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824961|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824962|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824963|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824964|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824965|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825058|NCT01310400|E2|Reported Event|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
825245|NCT01309828|B3|Baseline|Total|Total of all reporting groups
824966|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824967|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825006|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825098|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate as their first therapy. They may take this from 1 mo-18 mo.
824968|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824969|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824970|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824971|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (&lt; 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (&gt;=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824972|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824973|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824974|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824975|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824976|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824977|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824978|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825059|NCT01310400|E1|Reported Event|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
825345|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
824979|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825007|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824980|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824981|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824982|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824983|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824984|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824985|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|SSubjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824986|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824987|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824988|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824989|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824990|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824991|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825082|NCT01309997|B1|Baseline|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
825008|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824992|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824993|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824994|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824995|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824996|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824997|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824998|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
824999|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825000|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825001|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825002|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825003|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825004|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825150|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
825009|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825010|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825011|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825012|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825013|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825014|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825015|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825016|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825017|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825018|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825151|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825019|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825020|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825021|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825085|NCT01309997|O4|Outcome|Imatinib Nonresponders|Did not attain a SCR with imatinib
825086|NCT01309997|O3|Outcome|Imatinib Responders|Attained a SCR with imatinib
825022|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825023|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825024|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825025|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825026|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825027|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825028|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825029|NCT01310413|O6|Outcome|Placebo 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825030|NCT01310413|O5|Outcome|Placebo 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825031|NCT01310413|O4|Outcome|Placebo 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825152|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
825153|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825154|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
825032|NCT01310413|O3|Outcome|Influenza A (H5N1) Adjuvanted 9-<18Y Group|Subjects aged at enrolment between 9 and 18 years, 18 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825033|NCT01310413|O2|Outcome|Influenza A (H5N1) Adjuvanted 3-<9Y Group|Subjects aged at enrolment between 3 and 9 years, 9 years excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly, Dose 1 in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825087|NCT01309997|O2|Outcome|Rituximab Non-responders|Did not attain a SCR with rituximab
825088|NCT01309997|O1|Outcome|Rituximab Responders|Attained a SCR with rituximab
825089|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
825090|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
825034|NCT01310413|O1|Outcome|Influenza A (H5N1) Adjuvanted 6-<36M Group|Subjects aged at enrolment between 3 and 36 months, 36 months excluded, received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (< 12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (>=) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825035|NCT01310413|E3|Reported Event|Placebo/Influenza A (H5N1) Adjuvanted Group|Subjects in this group were those who were administered the saline placebo solution in the Blinded Phase of the study (either in the Placebo 6≤36M, Placebo 3≤9Y or Placebo 9≤18Y Group). These were subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who had received 2 doses of saline placebo at Days 0 and 21 in the Blinded Phase of the study, as per described in the descriptions of the Placebo 6≤36M, Placebo 3≤9Y and Placebo 9≤18Y groups. After consenting to participating to the Unblinded Phase of the study, these subjects received in addition 2 doses of Influenza A (H5N1) Virus monovalent vaccine at Days 385 (Day U0) and Day 385 + 21 days (Day U21). Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. Dose 1 was administered in the deltoid region of the non–dominant arm and Dose 2 in the deltoid region of the dominant arm.
825036|NCT01310413|E2|Reported Event|Placebo Group|This group results from the pooling of the Placebo 6-<36M, Placebo 3-<9Y and Placebo 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of 2 doses of saline placebo at Days 0 and 21. The saline placebo was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥) 12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825037|NCT01310413|E1|Reported Event|Influenza A (H5N1) Adjuvanted Group|This group results from the pooling of the Influenza A (H5N1) adjuvanted 6-<36M, Influenza A (H5N1) adjuvanted 3≤9Y and Influenza A (H5N1) adjuvanted 9≤18Y groups and includes subjects aged at enrolment between 6 months and 18 years, 18 years excluded, who received 2 doses of Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A vaccine or GSK Biologicals’ monovalent A/Indonesia/5/2005 (H5N1) vaccine adjuvanted) at Days 0 and 21. Influenza A (H5N1) Virus monovalent vaccine was administered intramuscularly. For children aged up to 12 months, 12 months excluded (<12 months), Dose 1 was administered in the left anterolateral thigh and Dose 2 in the right anterolateral thigh. For children older than (≥12 months, Dose 1 was administered in the deltoid region of the non–dominant arm (or left arm if dominance was not yet identified) and Dose 2 in the deltoid region of the dominant arm (or right arm).
825038|NCT01310400|B4|Baseline|Total|Total of all reporting groups
825039|NCT01310400|B3|Baseline|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
825040|NCT01310400|B2|Baseline|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
825041|NCT01310400|B1|Baseline|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
825042|NCT01310400|P3|Participant Flow|Agrippal 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
825043|NCT01310400|P2|Participant Flow|Inflexal V 0.25 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
825044|NCT01310400|P1|Participant Flow|Inflexal V 0.5 mL|Subjects received 2 doses: 1st dose on Day 0, 2nd dose on Day 28
825045|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
825046|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
825047|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The safety data are shown for the safety population (N = 452 for this group).
825048|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
825049|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
825050|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
825051|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
825052|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
825053|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
825054|NCT01310400|O3|Outcome|Agrippal 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 384 for this group).
825055|NCT01310400|O2|Outcome|Inflexal V 0.25 mL|The immunogenicity results are shown for the per-protocol population (N = 380 for this group).
825056|NCT01310400|O1|Outcome|Inflexal V 0.5 mL|The immunogenicity results are shown for the per-protocol population (N = 423 for this group).
825057|NCT01310400|E3|Reported Event|Agrippal 0.25 mL|The safety data are shown for the safety population (N = 451 for this group).
825060|NCT01310179|B1|Baseline|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
825091|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients randomized to receive rituximab IV as their first therapy. They may receive from 1-2 four week cycles.
825092|NCT01309997|O1|Outcome|Arm 1 (Enzyme Inhibitor)|Patients randomized to receive imatinib mesylate PO QD as their first therapy. They may take this from 1 mo-18 mo.
825061|NCT01310179|P1|Participant Flow|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
825062|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
825063|NCT01310179|O1|Outcome|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first three cohorts will receive 3x10e11 VP for 3 injections and 5, 15 or 25 mg/m2 of F-araAMP daily for 3 days. Subject in the fourth cohort will receive 3x10e12 VP for 3 injections and the highest tolerated dose of F-araAMP daily for 3 days.~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
825064|NCT01310179|E1|Reported Event|Ad/PNP and Fludarabine Monophosphate|"Ad/PNP will be injected three times into the tumor over 2 days followed by three daily intravenous infusions of F-araAMP (fludarabine monophosphate). Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days..~Ad/PNP and fludarabine monophosphate: Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days."
825065|NCT01310127|B3|Baseline|Total|Total of all reporting groups
825066|NCT01310127|B2|Baseline|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
825067|NCT01310127|B1|Baseline|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
825068|NCT01310127|P2|Participant Flow|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
825069|NCT01310127|P1|Participant Flow|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
825070|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
825071|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
825072|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
825073|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
825074|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
825075|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
825076|NCT01310127|O2|Outcome|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
825077|NCT01310127|O1|Outcome|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
825078|NCT01310127|E2|Reported Event|Nevanac|Nepafenac : nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
825079|NCT01310127|E1|Reported Event|Bromday|Bromfenac : bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
825080|NCT01309997|B3|Baseline|Total|Total of all reporting groups
825081|NCT01309997|B2|Baseline|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. TDuring the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
825155|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825156|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
825157|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825083|NCT01309997|P2|Participant Flow|Arm II (Monoclonal Antibody)|Patients receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle is repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to imatinib.
825084|NCT01309997|P1|Participant Flow|Arm I (Enzyme Inhibitor)|Patients receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity. During the 6mo study treatment period, if drug intolerance or disease progression is observed, they are crossed over to rituximab.
825099|NCT01309997|O2|Outcome|Arm II (Monoclonal Antibody)|Patients who were randomized to receive rituximab IV on days 1, 8, 15, and 22. A second treatment cycle was repeated at 3 months for a total of 8 doses of rituximab in the absence of progression of sclerosis or unacceptable toxicity.
825100|NCT01309997|O1|Outcome|Arm I (Enzyme Inhibitor)|Patients who were randomized to receive imatinib mesylate PO QD for 6 months in the absence of progression of sclerosis or unacceptable toxicity.
825101|NCT01309997|E4|Reported Event|Rituximab as Secondary Therapy|Arm II = rituximab, adverse event occurred after the start date of rituximab. (All participants in this group received imatinib prior).
825102|NCT01309997|E3|Reported Event|Imatinib as Secondary Therapy|Arm II = imatinib, adverse event occurred after the start date of imatinib. (All participants in this group received rituximab prior).
825103|NCT01309997|E2|Reported Event|Rituximab as Initial Therapy|Arm I = rituximab, adverse event occurred after the start date of rituximab and if applicable, prior to start date of imatinib.
825104|NCT01309997|E1|Reported Event|Imatinib as Initial Therapy|Arm I = imatinib, adverse event occurred after the start date of imatinib and if applicable, prior to start date of rituximab.
825105|NCT01309919|B3|Baseline|Total|Total of all reporting groups
825106|NCT01309919|B2|Baseline|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
825107|NCT01309919|B1|Baseline|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
825108|NCT01309919|P2|Participant Flow|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
825109|NCT01309919|P1|Participant Flow|Intrauterine Device (IUD) Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
825110|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
825111|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
825112|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
825113|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
825114|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
825158|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
825159|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825115|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
825116|NCT01309919|O2|Outcome|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
825117|NCT01309919|O1|Outcome|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
825118|NCT01309919|E2|Reported Event|Diary Arm|"Subjects who will not have an IUD placed postpartum; they may use another form of contraception, or no form at all~Diary: Subjects will keep a bleeding diary for three months"
825119|NCT01309919|E1|Reported Event|IUD Arm|"Subjects who receive an IUD within 48 hours of delivery (vaginal or cesarean birth)~IUD: Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.~Diary: Subjects will keep a bleeding diary for three months"
825120|NCT01309893|B1|Baseline|Entire Study Population|All eligible enrolled participants
825121|NCT01309893|P2|Participant Flow|Air Optix Aqua Lens First, Then Investigational Lens|Enrolled participants spent 1 week using Air Optix Aqua Lens, and then crossed over to 1 week using Investigational Lens. The order of contact lens use was randomized and participant-masked.
825122|NCT01309893|P1|Participant Flow|Investigational Lens First, Then Air Optix Aqua Lens|Enrolled participants spent 1 week using Investigational Lens, and then crossed over to 1 week using Air Optix Aqua lens. The order of contact lens use was randomized and participant-masked.
825123|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
825124|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
825125|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
825126|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
825127|NCT01309893|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
825128|NCT01309893|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
825129|NCT01309893|E2|Reported Event|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens~Air Optix Aqua lens: Lenses worn on a daily wear basis for one week"
825130|NCT01309893|E1|Reported Event|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel contact lens~Investigational Lens: Lenses worn on a daily wear basis for one week"
825131|NCT01309880|B1|Baseline|Overall Study|One-half of the participants (33) were randomized to receive the investigational RD2117-01 ID4 contact lens, and the other half (33) was randomized to receive the Air Optix Aqua contact lens. Both groups wore the lenses on a daily wear basis. After one week of wearing the first lens type, the subjects returned for an exam and crossed over to the second lens type for one week.
825132|NCT01309880|P2|Participant Flow|Test Lens Then Air Optix Aqua|The test lens was an Investigational silicone hydrogel contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to Ciba Vision Air Optix Aqua contact lens.. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
825133|NCT01309880|P1|Participant Flow|Air Optix Aqua Then Test Lens|Ciba Vision Air Optix Aqua contact lens. Lenses were worn on a daily wear basis. After one week participants crossed over to the Test lens. All subjects were provided with Bausch + Lomb renu® fresh™ multi-purpose solution and lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses, and Bausch + Lomb Sensitive Eyes® Rewetting Drops for use as needed during the study.
825134|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
825135|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
825136|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
825137|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
825138|NCT01309880|O2|Outcome|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
825139|NCT01309880|O1|Outcome|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
825140|NCT01309880|E2|Reported Event|Test Lens|"Investigational silicone hydrogel contact lens~Test lens: Investigational silicone hydrogel contact lens worn on a daily wear basis"
825141|NCT01309880|E1|Reported Event|Air Optix Aqua|"Ciba Vision daily wear contact lens~Air Optix Aqua: Air Optix Aqua contact lens worn on a daily wear basis"
825142|NCT01308788|B3|Baseline|Total|Total of all reporting groups
825143|NCT01308788|B2|Baseline|Aqueous Outflow|aqueous outflow treated
825144|NCT01308788|B1|Baseline|Aqueous Suppressant|aqueous suppressant treated
825145|NCT01308788|P2|Participant Flow|Aqueous Suppressant|aqueous suppressant treated
825146|NCT01308788|P1|Participant Flow|Aqueous Outflow|aqueous outflow treated
825147|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825148|NCT01308788|O1|Outcome|Aqueous Outflow|aqueous outflow treated
825149|NCT01308788|O2|Outcome|Aqueous Suppressant|aqueous suppressant treated
825183|NCT01308762|P1|Participant Flow|IMM-101 0.1 mg|Patients received an intradermal injection of IMM-101 0.1 mg on three occasions. Doses were administered over a four week period on days 0, 14 and 28.
825184|NCT01308762|O3|Outcome|Group 3|IMM-101 1.0 mg
825185|NCT01308762|O2|Outcome|Group 2|IMM-101 0.5 mg
825186|NCT01308762|O1|Outcome|Group 1|IMM-101 0.1 mg
825187|NCT01308762|O3|Outcome|IMM-101 1.0 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
825188|NCT01308762|O2|Outcome|IMM-101 0.5 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
825189|NCT01308762|O1|Outcome|IMM-101 0.1 mg|IMM-101 was administered on 3 separate occasions to the same individual over a 4 week period (Day 1, 14 and 28).
825190|NCT01308762|E3|Reported Event|Group 3|IMM-101 1.0 mg
825191|NCT01308762|E2|Reported Event|Group 2|IMM-101 0.5 mg
825192|NCT01308762|E1|Reported Event|Group 1|IMM-101 0.1 mg
825193|NCT01308736|B3|Baseline|Total|Total of all reporting groups
825194|NCT01308736|B2|Baseline|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
825195|NCT01308736|B1|Baseline|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
825196|NCT01308736|P2|Participant Flow|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
825197|NCT01308736|P1|Participant Flow|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
825198|NCT01308736|O2|Outcome|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
825199|NCT01308736|O1|Outcome|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
825200|NCT01308736|E2|Reported Event|Placebo Pill|Placebo pill: Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
825201|NCT01308736|E1|Reported Event|Varenicline|Varenicline: Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
825202|NCT01309841|B4|Baseline|Total|Total of all reporting groups
825203|NCT01309841|B3|Baseline|Placebo|Placebo QD, oral treatment
825204|NCT01309841|B2|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825205|NCT01309841|B1|Baseline|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825206|NCT01309841|P3|Participant Flow|Placebo|Placebo QD, oral treatment
825207|NCT01309841|P2|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825208|NCT01309841|P1|Participant Flow|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825209|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825210|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825211|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825212|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825213|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825214|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825215|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825216|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825217|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825218|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825219|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825220|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825221|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825222|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825223|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825224|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825225|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825226|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825227|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825228|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825229|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825230|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825231|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825232|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825233|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825234|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825235|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825236|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825237|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825238|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825239|NCT01309841|O3|Outcome|Placebo|Placebo QD, oral treatment
825240|NCT01309841|O2|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
825241|NCT01309841|O1|Outcome|NKTR-118 12.5 mg|NKTR-118 12.5 QD, oral treatment
825242|NCT01309841|E3|Reported Event|Placebo|
825243|NCT01309841|E2|Reported Event|NKTR-118 25 mg|
825246|NCT01309828|B2|Baseline|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
825247|NCT01309828|B1|Baseline|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
825248|NCT01309828|P2|Participant Flow|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
825249|NCT01309828|P1|Participant Flow|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
825250|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
825251|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
825252|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
825253|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
825254|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
825255|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
825256|NCT01309828|O2|Outcome|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
825257|NCT01309828|O1|Outcome|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
825258|NCT01309828|E2|Reported Event|Olmesartan Medoxomil + Hydrochlorothiazide|United States: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets (OLM/HCTZ), titrated up to olmesartan medoxomil 40 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks. Europe: Olmesartan medoxomil 20 mg plus hydrochlorothiazide 12.5 mg fixed dose combination tablets, titrated up to olmesartan medoxomil 20 mg plus hydrochlorothiazide 25 mg orally, once daily for up to 52 weeks.
825259|NCT01309828|E1|Reported Event|Azilsartan Medoxomil + Chlorthalidone|United States and Europe: Azilsartan medoxomil 20 mg plus chlorthalidone 12.5 mg fixed dose combination tablets (TAK-491CLD), titrated up to azilsartan medoxomil 40 mg plus chlorthalidone 25 mg orally, once daily for up to 52 weeks.
825260|NCT01309802|B3|Baseline|Total|Total of all reporting groups
825261|NCT01309802|B2|Baseline|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825262|NCT01309802|B1|Baseline|Placebo|no intervention
825263|NCT01309802|P2|Participant Flow|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825264|NCT01309802|P1|Participant Flow|Placebo|no intervention
825298|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825299|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825300|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825265|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825266|NCT01309802|O1|Outcome|Placebo|no intervention
825267|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825268|NCT01309802|O1|Outcome|Placebo|no intervention
825269|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825270|NCT01309802|O1|Outcome|Placebo|no intervention
825271|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825272|NCT01309802|O1|Outcome|Placebo|no intervention
825273|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825275|NCT01309802|O2|Outcome|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825276|NCT01309802|O1|Outcome|Placebo|no intervention
825277|NCT01309802|E2|Reported Event|Onabotulinum Toxin Type-A|"up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1~onabotulinum toxin type-A: up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1"
825278|NCT01309802|E1|Reported Event|Placebo|no intervention
825279|NCT01309737|B4|Baseline|Total|Total of all reporting groups
825280|NCT01309737|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825281|NCT01309737|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825282|NCT01309737|B1|Baseline|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825283|NCT01309737|P5|Participant Flow|Placebo,CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825284|NCT01309737|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825285|NCT01309737|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825286|NCT01309737|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825287|NCT01309737|P1|Participant Flow|CP-690,550 5mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
825288|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825289|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825290|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825291|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825292|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825293|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825294|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825295|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825296|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825297|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825301|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825302|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825303|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825304|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825305|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825306|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825307|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825308|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825309|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825310|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825311|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825312|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825313|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825314|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825315|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825316|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825317|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825318|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825319|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825320|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825321|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825322|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825323|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825324|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825325|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825326|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825327|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825328|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825329|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825330|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825331|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825332|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825333|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825334|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825335|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825336|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825337|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825338|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825339|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825340|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825341|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825342|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825343|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825344|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825346|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825347|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825348|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825349|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825350|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825351|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825352|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825353|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825354|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825355|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825356|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825357|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825358|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825359|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825360|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825361|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825362|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825363|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825364|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825365|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825366|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825367|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825368|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825369|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825370|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825371|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825372|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825373|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825374|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825375|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825376|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825377|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825378|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825379|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825380|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825381|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825382|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825383|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825384|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825385|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825386|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825387|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825388|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825389|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825390|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825391|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825392|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825393|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825394|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825395|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825396|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825397|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825398|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825399|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825400|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825401|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825402|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825403|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825404|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825405|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825581|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825406|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825407|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825408|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825409|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825410|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825411|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825412|NCT01309737|O2|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825413|NCT01309737|O1|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825414|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825415|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825416|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825417|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825418|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and there after received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825419|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825420|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825421|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825422|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825423|NCT01309737|O3|Outcome|Placebo,CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825424|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825425|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825426|NCT01309737|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825427|NCT01309737|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825428|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825429|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825430|NCT01309737|O4|Outcome|Placebo, Then CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825431|NCT01309737|O3|Outcome|Placebo, Then CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825432|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825433|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825434|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825435|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825436|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825437|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825438|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825439|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825440|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825441|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825442|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825443|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825444|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825445|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825446|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825447|NCT01309737|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
825448|NCT01309737|O1|Outcome|CP-690,550 5mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
825449|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825450|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825452|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825453|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825454|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825455|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825456|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825457|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825458|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825459|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825460|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825461|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825462|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825463|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825464|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825465|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825466|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825467|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825468|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825469|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825470|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825471|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825472|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825473|NCT01309737|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
825474|NCT01309737|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825475|NCT01309737|O1|Outcome|CP-690,550 5mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
825476|NCT01309737|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
825477|NCT01309737|E4|Reported Event|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
825478|NCT01309737|E3|Reported Event|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
825479|NCT01309737|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
825480|NCT01309737|E1|Reported Event|CP-690,550 5mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Week 52.
825481|NCT01309672|B1|Baseline|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
825482|NCT01309672|P1|Participant Flow|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
825483|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
825484|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
825485|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
825486|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
825487|NCT01309672|O1|Outcome|Abiraterone Acetate + Prednisone|"Abiraterone, 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily~Prednisone, 5 mg, oral, 5 mg twice daily~abiraterone acetate: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily~Prednisone: 5 mg, oral, 5 mg twice daily"
825488|NCT01309672|E1|Reported Event|Abiraterone Acetate + Prednisone|Abiraterone: 1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); to be taken daily Prednisone: 5 mg, oral, 5 mg twice daily
825490|NCT01309659|B2|Baseline|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825491|NCT01309659|B1|Baseline|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825492|NCT01309659|P2|Participant Flow|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825493|NCT01309659|P1|Participant Flow|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825494|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825495|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825496|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825497|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825498|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825607|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825499|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825500|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825501|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825502|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825503|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825504|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825582|NCT01309581|E2|Reported Event|Methohexitol|
825583|NCT01309581|E1|Reported Event|Ketamine|
825584|NCT01309451|B3|Baseline|Total|Total of all reporting groups
825585|NCT01309451|B2|Baseline|Combine Group|Bevacizumab plus Ozurdex
825505|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825506|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825507|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825508|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825509|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825510|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825511|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825512|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825513|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825514|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825689|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825515|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825516|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825517|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825518|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825519|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825520|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825521|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825522|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825523|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825524|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825525|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825526|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825527|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825528|NCT01309659|O2|Outcome|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825529|NCT01309659|O1|Outcome|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825530|NCT01309659|E2|Reported Event|Wait List Control|"Subjects randomized to the wait list control group will have an observation visit at week 6 and week 12. After that they will begin treatment with IV iron infusion. They will receive 200mg IV iron sucrose a week for 5 weeks followed by 7 weeks of follow up~iron sucrose: Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825877|NCT01308424|P3|Participant Flow|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
825531|NCT01309659|E1|Reported Event|Immediate Intervention Group|"Subjects randomized to the immediate treatment group will be scheduled to begin treatment with IV iron infusion immediately (or within 2 business days). They will receive 200mg IV iron sucrose a week for 5 weeks followed by 19 weeks of follow up.~iron sucrose: Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter."
825532|NCT01309646|B3|Baseline|Total|Total of all reporting groups
825533|NCT01309646|B2|Baseline|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825534|NCT01309646|B1|Baseline|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825535|NCT01309646|P2|Participant Flow|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825536|NCT01309646|P1|Participant Flow|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825537|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825538|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825539|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825540|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825541|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825542|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825543|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825544|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825608|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825878|NCT01308424|P2|Participant Flow|Matching Placebo|Matching placebo : sublingual dosing for 7 days
825545|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825546|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825547|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825548|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825562|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825549|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825550|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825551|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825552|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825553|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825554|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825555|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825556|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825557|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825609|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825558|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825559|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825560|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825561|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825563|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825564|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825565|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825566|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825567|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825568|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825569|NCT01309646|O2|Outcome|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825570|NCT01309646|O1|Outcome|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825610|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825690|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825571|NCT01309646|E2|Reported Event|Infanrix IPV Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825572|NCT01309646|E1|Reported Event|Infanrix-IPV+Hib Group|Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
825573|NCT01309581|B3|Baseline|Total|Total of all reporting groups
825574|NCT01309581|B2|Baseline|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825575|NCT01309581|B1|Baseline|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825576|NCT01309581|P2|Participant Flow|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825577|NCT01309581|P1|Participant Flow|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825578|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825579|NCT01309581|O1|Outcome|Ketamine|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825580|NCT01309581|O2|Outcome|Methohexital|Participants receiving ECT for depression will be randomized 1:1 to either ketamine (experimental condition) or methohexital (standard anesthetic).
825586|NCT01309451|B1|Baseline|Bevacizumab Alone|Bevacizumab only
825587|NCT01309451|P2|Participant Flow|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
825588|NCT01309451|P1|Participant Flow|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
825589|NCT01309451|O2|Outcome|Combined Group|bevacizumab plus Ozurdex group received bevacizumab at baseline followed by Ozurdex at the one month visit. Retreatment with bevaciumab given at monthly intervals when retreatment criteria met except for months 5 and 10 when retreatment with Ozurdex was given.
825590|NCT01309451|O1|Outcome|Bevacizumab Alone|monthly injection of bevacizumab intravitreally when retreatment criteria met
825591|NCT01309451|O2|Outcome|Combined Group|"Bevacizumab plus Ozurdex~Bevacizumab: intravitreal, 1.25mg., monthly~dexamethasone intravitreal implant: 0.7mg, intravitreal every 4 months"
825592|NCT01309451|O1|Outcome|Bevacizumab Alone|Bevacizumab: intravitreal, 1.25mg., monthly
825593|NCT01309451|E2|Reported Event|Combined Group|bevacizumab 1.25mg intravitreally plus Ozurdex THIS GROUP ALSO INCLUDES PARTICIPANTS WHO HAD BOTH EYES IN THE STUDY (they received bevacizumab alone in one eye and bavacizumab + Ozurdex in the other.
825594|NCT01309451|E1|Reported Event|Bevacizumab Alone Group|bevacizumab 1.25mg intravitreally
825595|NCT01309386|B3|Baseline|Total|Total of all reporting groups
825596|NCT01309386|B2|Baseline|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825597|NCT01309386|B1|Baseline|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825598|NCT01309386|P2|Participant Flow|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825599|NCT01309386|P1|Participant Flow|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825600|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825601|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825602|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825603|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825604|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825605|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825606|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825611|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825612|NCT01309386|O2|Outcome|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825613|NCT01309386|O1|Outcome|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825614|NCT01309386|E2|Reported Event|Morphine SR|Morphine sustained-release (SR) oral tablets 30 to 120 mg daily for 8 weeks (maximum dose could be up to 140 mg daily), as per Investigator’s discretion.
825615|NCT01309386|E1|Reported Event|Tapentadol ER|Tapentadol extended-release (ER) (JNS024ER) oral tablets 100 to 400 milligram (mg) daily for 8 weeks (maximum dose could be up to 500 mg daily), as per Investigator’s discretion.
825616|NCT01309360|B4|Baseline|Total|Total of all reporting groups
825617|NCT01309360|B3|Baseline|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825618|NCT01309360|B2|Baseline|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825619|NCT01309360|B1|Baseline|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
825620|NCT01309360|P3|Participant Flow|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825621|NCT01309360|P2|Participant Flow|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825622|NCT01309360|P1|Participant Flow|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
825623|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825624|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825625|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
825626|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825627|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825628|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
825629|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825630|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825631|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
825632|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825633|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825634|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
825635|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825636|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825637|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
825638|NCT01309360|O3|Outcome|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825639|NCT01309360|O2|Outcome|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825640|NCT01309360|O1|Outcome|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
825641|NCT01309360|E3|Reported Event|Group C : 20ml Prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
825642|NCT01309360|E2|Reported Event|Group B : 30ml Prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
825643|NCT01309360|E1|Reported Event|Group A : 40ml Prilocaine 1%|40 outpatients : 40ml Prilocaine 1% were administered for axillary plexus block
825644|NCT01309308|B3|Baseline|Total|Total of all reporting groups
825645|NCT01309308|B2|Baseline|No Sweeping Group|The patients who did not have sweeping of the membranes
825646|NCT01309308|B1|Baseline|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
825647|NCT01309308|P2|Participant Flow|No Sweeping Group|The patients who did not have sweeping of the membranes
825648|NCT01309308|P1|Participant Flow|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
825649|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
825650|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
825651|NCT01309308|O2|Outcome|Not Swept|Patients whose membranes are not swept
825652|NCT01309308|O1|Outcome|Sweeping|In women who had completed 38 weeks of gestation sweeping was performed by separating the lower membranes as much as possible from their cervical attachment, with three circumferential passes of the examining fingers for only once.
825653|NCT01309308|E2|Reported Event|No Sweeping Group|The patients who did not have sweeping of the membranes
825654|NCT01309308|E1|Reported Event|The Membranes Swept Group|The patient whose amniotic membranes are detached by the circular movements of the examining fingers
825655|NCT01309282|B1|Baseline|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825881|NCT01308424|O1|Outcome|Matching Placebo|Matching placebo : sublingual dosing for 7 days
825656|NCT01309282|P1|Participant Flow|Rituximab|Participants with sero-positive [Rheumatoid Factor (RF) and/or anti-Cyclic Citrullinated Peptide (CCP+)] rheumatoid arthritis (RA), who had commenced therapy with rituximab (MabThera) following lack of response or intolerance to a single tumor necrosis factor (TNF)-inhibitor were included in this arm.
825657|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825658|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825659|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825660|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825661|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825662|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825663|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825664|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825665|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825666|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825667|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825855|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825668|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825669|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825670|NCT01309282|O1|Outcome|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825671|NCT01309282|E1|Reported Event|Rituximab|Participants with sero-positive (RF and/or CCP+) RA, who had commenced therapy with rituximab following lack of response or intolerance to a single TNF-inhibitor, were included in this arm.
825672|NCT01309269|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
825673|NCT01309269|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
825674|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
825675|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
825676|NCT01309269|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
825677|NCT01309269|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 24 months. The actual dose was chosen by the physician and was adjusted as necessary.
825678|NCT01309243|B3|Baseline|Total|Total of all reporting groups
825679|NCT01309243|B2|Baseline|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825680|NCT01309243|B1|Baseline|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825681|NCT01309243|P2|Participant Flow|EFV/FTC/TDF|Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825682|NCT01309243|P1|Participant Flow|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily
825683|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825684|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825685|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825686|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825687|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825688|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825691|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825692|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825693|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825694|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825695|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825696|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825697|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825698|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825699|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825700|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825701|NCT01309243|O2|Outcome|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825702|NCT01309243|O1|Outcome|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825703|NCT01309243|E2|Reported Event|EFV/FTC/TDF|EFV 600 mg/FTC 200 mg/TDF 300 mg STR administered orally once daily
825704|NCT01309243|E1|Reported Event|FTC/RPV/TDF|FTC 200 mg/RPV 25 mg/TDF 300 mg STR administered orally once daily
825705|NCT01309204|B3|Baseline|Total|Total of all reporting groups
825706|NCT01309204|B2|Baseline|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825707|NCT01309204|B1|Baseline|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825708|NCT01309204|P2|Participant Flow|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825816|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825709|NCT01309204|P1|Participant Flow|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825710|NCT01309204|O2|Outcome|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825711|NCT01309204|O1|Outcome|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825712|NCT01309204|E2|Reported Event|Brinz+Brim|Brimonidine tartrate 0.2% ophthalmic solution, 1 drop instilled in each eye, followed by Brinzolamide 1% ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825713|NCT01309204|E1|Reported Event|Brinz/Brim|Vehicle, 1 drop instilled in each eye, followed by Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension, 1 drop instilled in each eye. A 10-minute waiting period separated the instillations. Study drugs were instilled twice a day for 6 months.
825714|NCT01309100|B1|Baseline|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
825715|NCT01309100|P1|Participant Flow|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
825716|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.~Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
825717|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
825718|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.~Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
825719|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
825720|NCT01309100|O2|Outcome|Acuvue Oasys Lens|"Johnson & Johnson Acuvue Oasys contact lens.~Acuvue Oasys Lens: Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week."
825721|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens(RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
825722|NCT01309100|O2|Outcome|Air Optix Aqua Lens|"Ciba Vision Air Optix Aqua contact lens.~Air Optix Aqua Lens: Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week."
825723|NCT01309100|O1|Outcome|Investigational Lens|"Bausch & Lomb investigational silicone hydrogel lens (RD2117-01).~Investigational Lens: Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week."
825724|NCT01309100|E1|Reported Event|Overall Study|Participants were equally randomized to one of 6 treatment sequences: RD2117-01, Air Optix Aqua, Acuvue Oasys; RD2117-01, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, RD2117-01, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, RD2117-01; Acuvue Oasys, RD2117-01, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, RD2117-01. All participants wore each of the 3 lenses for one week.
825725|NCT01308918|B1|Baseline|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
825726|NCT01308918|P1|Participant Flow|GlideScope DLT Intubation With GlideRite DLT Stylet|The double lumen tube (DLT) is the technique of choice to obtain lung isolation. The GlideScope® (GLS, video laryngoscope allowing vizualisation of the airway and tube placement, has been used with a high level of success to assist positioning a single lumen tube (SLT) in normal situations and mainly in situations where the airway is considered or proven to be difficult.We have designed a new semi-rigid intubating stylet, the GlideRite DLT Stylet® (GR-DLT-S), which can be used for primary DLT intubation with the GLS. This pilot study was planned to observe the efficiency and the safety of the GR-DLT-S for primary insertion of DLT with the GLS in patients presenting a normal superior airway. After obtaining local IRB approval, 50 patients scheduled for thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy at l’Institut de cardiologie et de pneumologie de Québec, were enrolled in this observational study.
825727|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
825728|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
825729|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
825730|NCT01308918|O1|Outcome|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
825731|NCT01308918|E1|Reported Event|GlideScope DLT Intubation|Patients having a thoracic surgery (non cardiac) via either thoracoscopy or thoracostomy. Patients were all 18 years old or over, and have read, understood and signed an informed consent at the preoperative evaluation or on surgery morning.
825732|NCT01308840|B1|Baseline|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
825733|NCT01308840|P1|Participant Flow|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
825734|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
825735|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
825736|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
825737|NCT01308840|O1|Outcome|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
825738|NCT01308840|E1|Reported Event|Panitumumab|"Panitumumab 6mg/kg on days 1 and 15 of every cycle (28 days); Gemcitabine 1000mg/m2 on days 1 and 15 of every cycle (28 days); Oxaliplatin 85mg/m2 on days 1 and 15 of every cycle (28 days)~Panitumumab: Day 1 and 15 = 6 mg/kg IV~oxaliplatin: Days 1 and 15 = 85mg/m2 IV~gemcitabine: Days 1 and 15 = 1000 mg/m2 IV"
825739|NCT01308619|B3|Baseline|Total|Total of all reporting groups
825740|NCT01308619|B2|Baseline|Placebo|placebo
825741|NCT01308619|B1|Baseline|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
825742|NCT01308619|P2|Participant Flow|Placebo Capsules|Placebo capsules for 12 weeks
825743|NCT01308619|P1|Participant Flow|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules for 12 weeks
825744|NCT01308619|O2|Outcome|Placebo|placebo
825745|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
825746|NCT01308619|O2|Outcome|Placebo|placebo
825747|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
825748|NCT01308619|O2|Outcome|Treatment Failure|
825749|NCT01308619|O1|Outcome|Treatment Success|
825750|NCT01308619|O2|Outcome|Placebo|placebo
825751|NCT01308619|O1|Outcome|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
825752|NCT01308619|E2|Reported Event|Placebo|placebo
825753|NCT01308619|E1|Reported Event|Oracea®|Doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules
825754|NCT01308580|B3|Baseline|Total|Total of all reporting groups
825755|NCT01308580|B2|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825879|NCT01308424|P1|Participant Flow|Baseline Run In|Baseline period to assess eligibility before randomization
825880|NCT01308424|O2|Outcome|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
825756|NCT01308580|B1|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825757|NCT01308580|P2|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825758|NCT01308580|P1|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 intravenous (IV) infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until disease progression (DP), unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825759|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825760|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825761|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825762|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825763|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825817|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825764|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825765|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825766|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825767|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825768|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825769|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825770|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825771|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825772|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825773|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825774|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825775|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825776|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825777|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825778|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825805|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825779|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825780|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825781|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825782|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825783|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825784|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825785|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825786|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825787|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825788|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825789|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825790|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825791|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825792|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825793|NCT01308580|O2|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825794|NCT01308580|O1|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant's refusal of further study treatment or for a maximum of 10 cycles.
825795|NCT01308580|E2|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
825796|NCT01308580|E1|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion over 1 hour on Day 1 of each 21-day cycle in combination with Prednisone (or Prednisolone) 10 mg orally daily until DP, unacceptable toxicity, participant’s refusal of further study treatment or for a maximum of 10 cycles.
825797|NCT01308567|B4|Baseline|Total|Total of all reporting groups
825798|NCT01308567|B3|Baseline|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825799|NCT01308567|B2|Baseline|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825800|NCT01308567|B1|Baseline|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825801|NCT01308567|P3|Participant Flow|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825802|NCT01308567|P2|Participant Flow|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21–day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825803|NCT01308567|P1|Participant Flow|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 intravenous (IV) infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until disease progression (DP), unacceptable toxicity or participant’s refusal.
825804|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825806|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825807|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825808|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825809|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825810|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825811|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825812|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825813|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825814|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825815|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825818|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825819|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825820|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825821|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825822|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825823|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825824|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825825|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825826|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825827|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825828|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825829|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825830|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825831|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825832|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825833|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825834|NCT01308567|O3|Outcome|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825835|NCT01308567|O2|Outcome|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21 –day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825836|NCT01308567|O1|Outcome|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant’s refusal.
825837|NCT01308567|E3|Reported Event|Cabazitaxel 25 mg/m^2|Cabazitaxel 25 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
825838|NCT01308567|E2|Reported Event|Cabazitaxel 20 mg/m^2|Cabazitaxel 20 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
825839|NCT01308567|E1|Reported Event|Docetaxel 75 mg/m^2|Docetaxel (TXT) 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle in combination with Prednisone 10 mg orally, once daily until DP, unacceptable toxicity or participant's refusal.
825840|NCT01308476|B3|Baseline|Total|Total of all reporting groups
825841|NCT01308476|B2|Baseline|Control Group|Control group with same medication but not receiving reminder SMS.
825842|NCT01308476|B1|Baseline|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825843|NCT01308476|P2|Participant Flow|Control Group|Control group with same medication but not receiving reminder SMS.
825844|NCT01308476|P1|Participant Flow|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825845|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825846|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825847|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825848|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825849|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825850|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825851|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825852|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825853|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825854|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825856|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825857|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825858|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825859|NCT01308476|O2|Outcome|Control Group|Control group with same medication but not receiving reminder SMS.
825860|NCT01308476|O1|Outcome|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825861|NCT01308476|E2|Reported Event|Control Group|Control group with same medication but not receiving reminder SMS.
825862|NCT01308476|E1|Reported Event|SMS Reminder Group|Patients receive a daily SMS to remind them to inhale Spiriva 18 mcg by using HandiHaler.
825863|NCT01308463|B1|Baseline|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
825864|NCT01308463|P1|Participant Flow|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
825865|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
825866|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
825867|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
825868|NCT01308463|O1|Outcome|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
825869|NCT01308463|E1|Reported Event|Discovery Elbow|This arm includes all subjects who underwent total elbow arthroplasty with the Discovery Total Elbow and entered the long-term survival study.
825870|NCT01308450|B1|Baseline|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
825871|NCT01308450|P1|Participant Flow|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
825872|NCT01308450|O1|Outcome|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
825873|NCT01308450|E1|Reported Event|Adolescent and Adult Normative Group|"Males and Females from ages 15 -55 divided into 4 age groups: 15-25; 26-35;36-45 and 46-55 with each group having approximately equal representation of both genders. Subjects will be recruited to represent a normative adolescent and adult sampling of subjects who are not known to have ADHD."
825874|NCT01308424|B3|Baseline|Total|Total of all reporting groups
825875|NCT01308424|B2|Baseline|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
825876|NCT01308424|B1|Baseline|Matching Placebo|Matching placebo : sublingual dosing for 7 days
825882|NCT01308424|E3|Reported Event|BTL TML HSV|BTL TML HSV : Sublingual micro-dosing for 7 days
825883|NCT01308424|E2|Reported Event|Matching Placebo|Matching placebo : sublingual dosing for 7 days
825884|NCT01308424|E1|Reported Event|Baseline Run In|Baseline period to assess eligibility before randomization
825885|NCT01307787|B3|Baseline|Total|Total of all reporting groups
825886|NCT01307787|B2|Baseline|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
825887|NCT01307787|B1|Baseline|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
825888|NCT01307787|P2|Participant Flow|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
825889|NCT01307787|P1|Participant Flow|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
825890|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
825891|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
825892|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
825893|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
825894|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
825895|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
825896|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
825897|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
825898|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
825899|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component
825900|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention, allowed to follow the program after the study
825901|NCT01307787|O1|Outcome|Intervention Fitprogram Group|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
825902|NCT01307787|O2|Outcome|Waiting List Control Group|no intervention. WLC was allowed to follow the program after the study.
825903|NCT01307787|O1|Outcome|Intervention Fit Program|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component.
825904|NCT01307787|O2|Outcome|Waiting List Control Group|No intervention. The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
825905|NCT01307787|O1|Outcome|Intervention Fit Program|An eight week multi-disciplinary group-therapy program for people with RA, consisting of physical exercise designed to increase aerobic capacity and muscle strength together with an educational program to improve health status and self-efficacy for disease-self-management.
825906|NCT01307787|E2|Reported Event|Waiting List Control Group|The waiting list control group did not have an intervention during the evaluation part of the study.The waiting-list control group was allowed to enter the FIT program for rehabilitation after the study period.
825907|NCT01307787|E1|Reported Event|Fit-program|"Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part took place in group sessions and consisted of a muscle exercise circuit and bicycle training once a week for sixty minutes, sport once a week for sixty minutes and aqua jogging twice a week for thirty minutes.~The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals consisting of a psychologist, physical therapist, occupational therapist, dietician and a social worker gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants’ actual energy level."
825908|NCT01307618|B3|Baseline|Total|Total of all reporting groups
825971|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825909|NCT01307618|B2|Baseline|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825910|NCT01307618|B1|Baseline|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825911|NCT01307618|P2|Participant Flow|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825912|NCT01307618|P1|Participant Flow|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825913|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825914|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825915|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825916|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825917|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825918|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825919|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825920|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825921|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825922|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825923|NCT01307618|O2|Outcome|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825924|NCT01307618|O1|Outcome|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825925|NCT01307618|E2|Reported Event|Arm II (Vaccine Therapy, IL-12)|"Patients receive vaccination as in arm I with an admixture of IL-12 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~Recombinant Interleukin-12: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825926|NCT01307618|E1|Reported Event|Arm I (Vaccine Therapy)|"Patients receive vaccination comprising recombinant MAGE-3.1 antigen, MART-1 antigen, gp100 antigen, and NA17-A2 peptide emulsified with Montanide ISA-51 ID or SC on days 1, 22, and 50.~NA17.A2 Peptide Vaccine: Given SC or ID~Recombinant MAGE-3.1 Antigen: Given SC or ID~MART-1 Antigen: Given SC or ID~Laboratory Biomarker Analysis: Correlative studies"
825927|NCT01307423|B4|Baseline|Total|Total of all reporting groups
825928|NCT01307423|B3|Baseline|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
825929|NCT01307423|B2|Baseline|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
825930|NCT01307423|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825931|NCT01307423|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
825932|NCT01307423|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
825933|NCT01307423|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years
825934|NCT01307423|P4|Participant Flow|Placebo/ 20mg Apremilast EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
825935|NCT01307423|P3|Participant Flow|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
825936|NCT01307423|P2|Participant Flow|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
825937|NCT01307423|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
825938|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825939|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825940|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825941|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825942|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825943|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825944|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825945|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825946|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825947|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825948|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825949|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825950|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825951|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825952|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825953|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825954|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825955|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825956|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825957|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825958|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825959|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825960|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825961|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825962|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825963|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825964|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825965|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825966|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825967|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825968|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825969|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825970|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825972|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825973|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825974|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825975|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825976|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825977|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825978|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825979|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
825980|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825981|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825982|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825983|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825984|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825985|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825986|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825987|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825988|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825989|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825990|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826115|NCT01307020|P9|Participant Flow|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
825991|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825992|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825993|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825994|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825995|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825996|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
825997|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
825998|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
825999|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826000|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
826001|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826002|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826003|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
826004|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826005|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826006|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826007|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826008|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826009|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826010|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826011|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826012|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826013|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826014|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826015|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826016|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826017|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826018|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826019|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826020|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826021|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826022|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826023|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826024|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826025|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826026|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826027|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826028|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive Apremilast 30 mg tablets twice daily.
826029|NCT01307423|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive Apremilast 20 mg tablets twice daily.
826030|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
826031|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
826032|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
826033|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
826034|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
826035|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
826036|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826037|NCT01307423|O3|Outcome|Apremilast 30mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
826038|NCT01307423|O2|Outcome|Apremilast 20mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
826039|NCT01307423|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
826040|NCT01307423|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
826041|NCT01307423|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
826042|NCT01307423|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
826043|NCT01307423|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
826044|NCT01307423|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
826045|NCT01307319|B4|Baseline|Total|Total of all reporting groups
826046|NCT01307319|B3|Baseline|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
826047|NCT01307319|B2|Baseline|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826048|NCT01307319|B1|Baseline|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826049|NCT01307319|P3|Participant Flow|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
826050|NCT01307319|P2|Participant Flow|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826051|NCT01307319|P1|Participant Flow|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826052|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
826053|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826054|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826055|NCT01307319|O3|Outcome|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
826056|NCT01307319|O2|Outcome|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826057|NCT01307319|O1|Outcome|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826058|NCT01307319|E3|Reported Event|Placebo Nasal Aerosol Once Daily|Participants/parents administer placebo (a spray with no medication in each nostril) once daily for 15 days.
826059|NCT01307319|E2|Reported Event|BDP HFA 160 mcg/Day|Participants/parents administer 80 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826060|NCT01307319|E1|Reported Event|BDP HFA 80 mcg/Day|Participants/parents administer 40 mcg of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) (one spray per nostril) once daily for 15 days.
826061|NCT01307111|B4|Baseline|Total|Total of all reporting groups
826062|NCT01307111|B3|Baseline|Not Randomized|Women not eligible to continue to randomization.
826063|NCT01307111|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
826064|NCT01307111|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.
826065|NCT01307111|P2|Participant Flow|Placebo|"Pills which are identical to the study drug in appearance, taste, and smell.~Placebo: Pills which are identical to the study drug in appearance, taste, and smell."
826066|NCT01307111|P1|Participant Flow|Misoprostol|"Misoprostol 400 micrograms inserted buccally or vaginally, per the participants desire.~Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion."
826067|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
826068|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
826069|NCT01307111|O2|Outcome|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
826070|NCT01307111|O1|Outcome|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
826071|NCT01307111|E2|Reported Event|Placebo|Placebo: Pills which are identical to the study drug in appearance, taste, and smell.
826072|NCT01307111|E1|Reported Event|Misoprostol|Misoprostol: 400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
826073|NCT01307046|B3|Baseline|Total|Total of all reporting groups
826074|NCT01307046|B2|Baseline|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
826075|NCT01307046|B1|Baseline|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
826076|NCT01307046|P2|Participant Flow|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
826116|NCT01307020|P8|Participant Flow|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
826077|NCT01307046|P1|Participant Flow|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
826078|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
826079|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
826080|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
826081|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
826082|NCT01307046|O2|Outcome|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
826083|NCT01307046|O1|Outcome|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
826084|NCT01307046|E2|Reported Event|Losartan|Participants administered Losartan 100 mg, Placebo for MK-0954A, and Placebo for Losartan 50 mg orally, once daily for 8 weeks.
826085|NCT01307046|E1|Reported Event|MK-0954A|Participants administered MK-0954A, Placebo for Losartan 50 mg , and Placebo for Losartan 100 mg orally, once daily for 8 weeks.
826086|NCT01307033|B3|Baseline|Total|Total of all reporting groups
826087|NCT01307033|B2|Baseline|MK-0954A (L100/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension.
826088|NCT01307033|B1|Baseline|MK-0954H (L50/H12.5)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
826089|NCT01307033|P4|Participant Flow|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
826090|NCT01307033|P3|Participant Flow|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
826091|NCT01307033|P2|Participant Flow|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
826092|NCT01307033|P1|Participant Flow|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
826093|NCT01307033|O2|Outcome|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
826094|NCT01307033|O1|Outcome|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
826095|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
826096|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
826097|NCT01307033|O2|Outcome|MK-0954A (L100/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5).
826098|NCT01307033|O1|Outcome|MK-0954H (L50/H12.5)|One combination tablet daily for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5).
826099|NCT01307033|E4|Reported Event|L100/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will continue to receive MK-0954A orally, once daily for 44 week extension
826100|NCT01307033|E3|Reported Event|L50/H12.5→L100/H12.5 Open Label (Period 2)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5). Participants will then receive open label MK-0954A (L100/H12.5) orally, once daily for 44 weeks (extension)
826101|NCT01307033|E2|Reported Event|MK-0954A (L100/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 100 mg (L100) and 12.5 mg of hydrochlorothiazide (H12.5)
826102|NCT01307033|E1|Reported Event|MK-0954H (L50/H12.5) Double Blind Period (Period 1)|One combination tablet daily, orally, for 8 weeks. Each tablet contains Losartan 50 mg (L50) and 12.5 mg of hydrochlorothiazide (H12.5)
826103|NCT01307020|B11|Baseline|Total|Total of all reporting groups
826104|NCT01307020|B10|Baseline|Placebo|Placebo oral film-coated tablet, once
826105|NCT01307020|B9|Baseline|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
826106|NCT01307020|B8|Baseline|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
826107|NCT01307020|B7|Baseline|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
826108|NCT01307020|B6|Baseline|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
826109|NCT01307020|B5|Baseline|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
826110|NCT01307020|B4|Baseline|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
826111|NCT01307020|B3|Baseline|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826112|NCT01307020|B2|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
826113|NCT01307020|B1|Baseline|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826114|NCT01307020|P10|Participant Flow|Placebo|Placebo oral film-coated tablet, once
826117|NCT01307020|P7|Participant Flow|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
826118|NCT01307020|P6|Participant Flow|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
826119|NCT01307020|P5|Participant Flow|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
826120|NCT01307020|P4|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
826121|NCT01307020|P3|Participant Flow|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826122|NCT01307020|P2|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
826123|NCT01307020|P1|Participant Flow|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826124|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
826125|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
826126|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
826127|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
826128|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
826129|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
826130|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
826131|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826132|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
826133|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826134|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
826135|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
826136|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
826137|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
826138|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
826139|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
826140|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
826141|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826142|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
826143|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826144|NCT01307020|O10|Outcome|Placebo|Placebo oral film-coated tablet, once
826145|NCT01307020|O9|Outcome|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
826146|NCT01307020|O8|Outcome|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
826147|NCT01307020|O7|Outcome|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
826148|NCT01307020|O6|Outcome|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
826149|NCT01307020|O5|Outcome|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
826150|NCT01307020|O4|Outcome|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
826151|NCT01307020|O3|Outcome|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826152|NCT01307020|O2|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
826153|NCT01307020|O1|Outcome|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826154|NCT01307020|E10|Reported Event|Placebo|Placebo oral film-coated tablet, once
826155|NCT01307020|E9|Reported Event|Ibuprofen 400mg|Ibuprofen 400mg oral film-coated tablet, once
826156|NCT01307020|E8|Reported Event|TRAM.HCl 75mg|TRAM.HCl 75mg oral film-coated tablet, once
826157|NCT01307020|E7|Reported Event|TRAM.HCl 37.5mg|TRAM.HCl 37.5mg oral film-coated tablet, once
826158|NCT01307020|E6|Reported Event|DKP-TRIS 25mg|DKP-TRIS 25mg oral film-coated tablet, once
826159|NCT01307020|E5|Reported Event|DKP-TRIS 12.5mg|DKP-TRIS 12.5mg oral film-coated tablet, once
826160|NCT01307020|E4|Reported Event|DKP-TRIS 25mg - TRAM.HCl 75mg|DKP-TRIS 25mg - TRAM.HCl 75mg oral film-coated tablet, once
826161|NCT01307020|E3|Reported Event|DKP-TRIS 25mg - TRAM.HCl 37.5mg|DKP-TRIS 25mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826162|NCT01307020|E2|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 75mg|DKP-TRIS 12.5mg - TRAM.HCl 75mg oral film-coated tablet, once
826163|NCT01307020|E1|Reported Event|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg|DKP-TRIS 12.5mg - TRAM.HCl 37.5mg oral film-coated tablet, once
826164|NCT01306968|B5|Baseline|Total|Total of all reporting groups
826165|NCT01306968|B4|Baseline|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
826166|NCT01306968|B3|Baseline|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
826167|NCT01306968|B2|Baseline|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
826168|NCT01306968|B1|Baseline|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
826169|NCT01306968|P4|Participant Flow|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
826170|NCT01306968|P3|Participant Flow|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
826171|NCT01306968|P2|Participant Flow|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
826172|NCT01306968|P1|Participant Flow|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
826173|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
826174|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
826175|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
826176|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
826177|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
826201|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826202|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826178|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
826179|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
826180|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
826181|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
826182|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
826183|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD) Follow-up visit 2 = Day 56 (up to day 100)
826184|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
826185|NCT01306968|O4|Outcome|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
826186|NCT01306968|O3|Outcome|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
826187|NCT01306968|O2|Outcome|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
826188|NCT01306968|O1|Outcome|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
826189|NCT01306968|E4|Reported Event|Sham Group|"Routine PCS care supplemented with an otherwise identical sham hyperbaric air exposure at 1.2 atmospheres absolute (ATA)~sham hyperbaric air: A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions."
826190|NCT01306968|E3|Reported Event|HBO2 Group|"Routine PCS care supplemented with hyperbaric oxygen (HBO2) at the dose of 1.5 ATA for 60 minutes administered over 40 sessions given daily Monday through Friday~hyperbaric oxygen: The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
826191|NCT01306968|E2|Reported Event|Standard TBI Care|Routine post-concussive symptoms (PCS) care as practiced within Departments of Defense (DoD)
826192|NCT01306968|E1|Reported Event|PTSD With no History of TBI|Non-randomized - Subjects who have been diagnosed with PTSD but have no diagnosed or suspected brain injuries. This group did not receive hyperbaric oxygen.
826193|NCT01306877|B3|Baseline|Total|Total of all reporting groups
826194|NCT01306877|B2|Baseline|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826195|NCT01306877|B1|Baseline|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826196|NCT01306877|P2|Participant Flow|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set : Surgical device
826197|NCT01306877|P1|Participant Flow|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set : Surgical device
826198|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826199|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826200|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826203|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826204|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826205|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826206|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826207|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826208|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826209|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826210|NCT01306877|O2|Outcome|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826211|NCT01306877|O1|Outcome|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826212|NCT01306877|E2|Reported Event|Endosurgery Proximate PPH03 Stapling Set|Endosurgery Proximate PPH03 Stapling Set: Surgical device
826213|NCT01306877|E1|Reported Event|EEA Hemorrhoid and Prolapse Stapling Set|EEA Hemorrhoid and Prolapse Stapling Set: Surgical device
826214|NCT01306643|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826215|NCT01306643|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826216|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826217|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826218|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826219|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826220|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826221|NCT01306643|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826222|NCT01306643|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet(s) administered orally twice daily for a maximum of twelve 28-day cycles
826223|NCT01306617|B4|Baseline|Total|Total of all reporting groups
826317|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826224|NCT01306617|B3|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826225|NCT01306617|B2|Baseline|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826226|NCT01306617|B1|Baseline|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826227|NCT01306617|P3|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826228|NCT01306617|P2|Participant Flow|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826229|NCT01306617|P1|Participant Flow|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826230|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826231|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826232|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826233|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826234|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826235|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826236|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826237|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826238|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826385|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
826239|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826240|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826241|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826242|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826243|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826244|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826245|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826246|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826247|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826248|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826249|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826250|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826251|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826252|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826253|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826254|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826255|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826256|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826257|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826258|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826259|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826260|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826261|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826262|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826263|NCT01306617|O3|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826264|NCT01306617|O2|Outcome|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826386|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
826265|NCT01306617|O1|Outcome|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naïve|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826266|NCT01306617|E3|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Non-responders|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID in previous non-responders to pegylated interferon (pegIFN) and RBV.
826267|NCT01306617|E2|Reported Event|ABT-450/r (150/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (150/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826268|NCT01306617|E1|Reported Event|ABT-450/r (250/100 mg) and ABT-333 Plus RBV in Treatment-naive|ABT-450/r (250/100 mg) once daily (QD) and ABT-333 (400 mg) twice daily (BID) plus weight-based ribavirin (RBV) divided BID for 12 weeks in treatment-naïve participants.
826269|NCT01306305|B3|Baseline|Total|Total of all reporting groups
826270|NCT01306305|B2|Baseline|Elderly|Elderly subjects aged over 60 years
826271|NCT01306305|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
826272|NCT01306305|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
826273|NCT01306305|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
826274|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826275|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826276|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826277|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826278|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826279|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826280|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826281|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826282|NCT01306305|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826283|NCT01306305|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826284|NCT01306305|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
826285|NCT01306305|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
826286|NCT01306292|B3|Baseline|Total|Total of all reporting groups
826318|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826319|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826320|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826287|NCT01306292|B2|Baseline|Normal Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
826288|NCT01306292|B1|Baseline|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL.
826289|NCT01306292|P4|Participant Flow|Normal Group (Placebo First, Then SonoVue)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
826290|NCT01306292|P3|Participant Flow|Normal Group (SonoVue First, Then Placebo)|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
826291|NCT01306292|P2|Participant Flow|Hypertension Group (Placebo First, Then SonoVue)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who were randomized to receive Placebo (normal saline 0.9% for injection) first, then SonoVue. Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
826292|NCT01306292|P1|Participant Flow|Hypertension Group (SonoVue First, Then Placebo)|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who were randomized to receive SonoVue first, then Placebo (normal saline 0.9% for injection). Both agents were administered intravenously as a single bolus injection of 4.8 mL. The two injection were separated by an interval of at least 10 minutes.
826293|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
826294|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
826295|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
826296|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
826297|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
826298|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
826299|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
826300|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
826301|NCT01306292|O4|Outcome|Normal SonoVue|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
826302|NCT01306292|O3|Outcome|Normal Placebo|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure < 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
826303|NCT01306292|O2|Outcome|Hypertension SonoVue|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received SonoVue administered intravenously as a single bolus injection of 4.8 mL.
826304|NCT01306292|O1|Outcome|Hypertension Placebo|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥ 25.0 mmHg) who received Placebo (normal saline 0.9%) administered intravenously as a single bolus injection of 4.8 mL.
826305|NCT01306292|E2|Reported Event|Normal Pulmonary Pressure Group|Subjects without pulmonary hypertension (baseline mean pulmonary arterial pressure <25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
826306|NCT01306292|E1|Reported Event|Hypertension Group|Subjects with pulmonary hypertension (baseline mean pulmonary arterial pressure ≥25.0 mmHg) who received SonoVue and Placebo (normal saline 0.9% for injection) in randomized order, both administered intravenously as a single bolus injection of 4.8 mL. An interval of at least 10 minutes was allowed between the two injections (SonoVue and Placebo). All adverse events occurred hours after the completion of both injections and for the purposes of this study have been assigned to the administration of SonoVue.
826307|NCT01306253|B3|Baseline|Total|Total of all reporting groups
826308|NCT01306253|B2|Baseline|Elderly|Elderly subjects aged over 60 years
826309|NCT01306253|B1|Baseline|Adults|Adults from 18 to 60 years old inclusive
826310|NCT01306253|P2|Participant Flow|Elderly|Elderly subjects aged over 60 years
826311|NCT01306253|P1|Participant Flow|Adults|Adults from 18 to 60 years old inclusive
826312|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826313|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826314|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826315|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826316|NCT01306253|O2|Outcome|Elderly|Elderly subjects aged over 60 years
826321|NCT01306253|O1|Outcome|Adults|Adults from 18 to 60 years old inclusive
826322|NCT01306253|E2|Reported Event|Elderly|Elderly subjects aged over 60 years
826323|NCT01306253|E1|Reported Event|Adults|Adults from 18 to 60 years old inclusive
826324|NCT01306214|B4|Baseline|Total|Total of all reporting groups
826325|NCT01306214|B3|Baseline|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
826326|NCT01306214|B2|Baseline|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
826327|NCT01306214|B1|Baseline|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
826328|NCT01306214|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
826329|NCT01306214|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
826330|NCT01306214|P1|Participant Flow|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
826331|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
826332|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
826333|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
826334|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
826335|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
826336|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
826337|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
826338|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
826339|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
826340|NCT01306214|O3|Outcome|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
826341|NCT01306214|O2|Outcome|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
826342|NCT01306214|O1|Outcome|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
826343|NCT01306214|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin film-coated 25 mg tablet plus one placebo matching empagliflozin 10 mg tablet once daily
826344|NCT01306214|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin film-coated 10 mg tablet plus one placebo matching empagliflozin 25 mg tablet once daily
826345|NCT01306214|E1|Reported Event|Placebo|Placebo matching empagliflozin 10 mg tablet plus placebo matching empagliflozin 25 mg tablet once daily
826346|NCT01306201|B1|Baseline|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
826387|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
826388|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
826347|NCT01306201|P1|Participant Flow|Respiration Rate in GCF Patients|In-patients from the hospital general care floor, who choose to participate in the study. Participants were monitored for 30 minute periods to collect respiratory rate information from non-invasive sensors.
826348|NCT01306201|O1|Outcome|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
826349|NCT01306201|O1|Outcome|Overall Study Population|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
826350|NCT01306201|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate derived from Transthoracic Impedance
826351|NCT01306201|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide Waveform|Respiration rate determined by manual overscoring of capnography waveforms
826352|NCT01306201|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration rate determined by novel plethysmographic analysis
826353|NCT01306201|E1|Reported Event|In-patient Volunteers|In-patients from the hospital who choose to participate in the study
826354|NCT01306175|B1|Baseline|Study Total|"This was a randomised, two-period, cross-over trial, the two treatments administered were~A single dose of digoxin 0.5 mg on day 1~Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
826355|NCT01306175|P1|Participant Flow|Study Total|"This was a randomised, two-period cross-over trial, the two treatments administered were~A single dose of 0.5mg digoxin on day 1~empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5~Between treatment periods there was a washout period of at least 14 days."
826356|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
826357|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
826358|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
826359|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
826360|NCT01306175|O2|Outcome|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
826361|NCT01306175|O1|Outcome|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
826362|NCT01306175|E2|Reported Event|Digoxin and Empa|Empagliflozin (Empa) 25 mg once daily on days 1 to 8 combined with a single dose of 0.5 mg digoxin on day 5.
826363|NCT01306175|E1|Reported Event|Digoxin Alone|A single dose of digoxin 0.5 mg on day 1.
826364|NCT01306162|B5|Baseline|Total|Total of all reporting groups
826365|NCT01306162|B4|Baseline|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
826366|NCT01306162|B3|Baseline|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
826367|NCT01306162|B2|Baseline|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
826368|NCT01306162|B1|Baseline|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
826369|NCT01306162|P4|Participant Flow|TrtC -- TrtE -- TrtD -- TrtA|Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg (Trt. A)
826370|NCT01306162|P3|Participant Flow|TrtB -- TrtD -- TrtE -- TrtA|Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg (Trt. A)
826371|NCT01306162|P2|Participant Flow|TrtA -- TrtC -- TrtE -- TrtD|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given 2h later (Trt. C), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D)
826372|NCT01306162|P1|Participant Flow|TrtA -- TrtB -- TrtD -- TrtE|Dabigatran 150mg (Trt. A), followed by Dabigatran 150mg + Dronedarone 400mg given simultaneously (Trt. B), followed by Dabigatran 150mg + Dronedarone 400mg bid given simultaneously (Trt. D), followed by Dabigatran 150mg + Dronedarone 400mg bid given 2h later (Trt. E)
826373|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
826374|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
826375|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
826376|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
826377|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
826378|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
826379|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
826380|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
826381|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
826382|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
826383|NCT01306162|O5|Outcome|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
826384|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
826389|NCT01306162|O4|Outcome|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
826390|NCT01306162|O3|Outcome|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
826391|NCT01306162|O2|Outcome|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
826392|NCT01306162|O1|Outcome|150mg DE (TrtA)|Dabigatran 150mg
826393|NCT01306162|E6|Reported Event|400mg DR + 400mg DR Bid 2h Later (TrtE2)|Dronedarone 400mg + Dronedarone 400mg bid given 2h later
826394|NCT01306162|E5|Reported Event|150mg DE + 400mg DR Bid 2h Later (TrtE)|Dabigatran 150mg + Dronedarone 400mg bid given 2h later
826395|NCT01306162|E4|Reported Event|150mg DE + 400mg DR Bid Same Time (TrtD)|Dabigatran 150mg + Dronedarone 400mg bid given simultaneously
826396|NCT01306162|E3|Reported Event|150mg DE + 400mg DR 2h Later (TrtC)|Dabigatran 150mg + Dronedarone 400mg given 2h later
826397|NCT01306162|E2|Reported Event|150mg DE + 400mg DR (TrtB)|Dabigatran 150mg + Dronedarone 400mg given simultaneously
826398|NCT01306162|E1|Reported Event|150mg DE (TrtA)|Dabigatran 150mg
826399|NCT01306032|B7|Baseline|Total|Total of all reporting groups
826400|NCT01306032|B6|Baseline|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826401|NCT01306032|B5|Baseline|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
826402|NCT01306032|B4|Baseline|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826403|NCT01306032|B3|Baseline|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
826404|NCT01306032|B2|Baseline|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826405|NCT01306032|B1|Baseline|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO).
826406|NCT01306032|P6|Participant Flow|Non-Hodgkin's: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
826407|NCT01306032|P5|Participant Flow|Non-Hodgkin's: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826408|NCT01306032|P4|Participant Flow|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
826409|NCT01306032|P3|Participant Flow|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826410|NCT01306032|P2|Participant Flow|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days. Participants in the cyclophosphamide alone arm crossed over to the ABT-888 plus cyclophosphamide arm at time of disease progression.
826411|NCT01306032|P1|Participant Flow|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826412|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826413|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826414|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826415|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826416|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
826417|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826418|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826419|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826420|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826421|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826422|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826423|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826424|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
826425|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826426|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826427|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826428|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826429|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826430|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826839|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
826431|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826432|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
826433|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826434|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826435|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826436|NCT01306032|O8|Outcome|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826437|NCT01306032|O7|Outcome|Non-Hodgkin’s: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826438|NCT01306032|O6|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826439|NCT01306032|O5|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826440|NCT01306032|O4|Outcome|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth on a continuous schedule.
826441|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826442|NCT01306032|O2|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826443|NCT01306032|O1|Outcome|BRCA-positive Ovarian Cancer: ABT-888 & Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826444|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826445|NCT01306032|O3|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826446|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826447|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826708|NCT01304693|B1|Baseline|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
826448|NCT01306032|O6|Outcome|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826449|NCT01306032|O5|Outcome|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826450|NCT01306032|O4|Outcome|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826451|NCT01306032|O3|Outcome|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826452|NCT01306032|O2|Outcome|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826453|NCT01306032|O1|Outcome|Triple-negative Breast Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826454|NCT01306032|E8|Reported Event|Non-Hodgkin’s: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826455|NCT01306032|E7|Reported Event|Non-Hodgkin’s: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826456|NCT01306032|E6|Reported Event|Triple-negative Breast Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826457|NCT01306032|E5|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826458|NCT01306032|E4|Reported Event|Triple-negative Breast Cancer: Cyclophosphamide & ABT-888|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826459|NCT01306032|E3|Reported Event|BRCA-positive Ovarian Cancer: Crossover|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826460|NCT01306032|E2|Reported Event|BRCA-positive Ovarian Cancer: Cyclophosphamide Alone|Oral cyclophosphamide 50mg by mouth (PO) for 21 days.
826461|NCT01306032|E1|Reported Event|BRCA-positive Ovarian Cancer: ABT-888 + Cyclophosphamide|Oral cyclophosphamide 50mg by mouth (PO) for 21 days and oral ABT-888 60mg by mouth (PO) on a continuous schedule.
826462|NCT01305811|B3|Baseline|Total|Total of all reporting groups
826463|NCT01305811|B2|Baseline|Wait List|Wait list for 2 months then weekly acupuncture for four months
826464|NCT01305811|B1|Baseline|Bi-weekly Acupuncture Treatment|Bi-weekly acupuncture treatment for 6 months
826465|NCT01305811|P2|Participant Flow|Wait List|Veterans with diagnosed symptoms of Gulf War Illness were randomized to 2 months of waitlist followed by weekly acupuncture treatments for 4 months.
826466|NCT01305811|P1|Participant Flow|Bi-weekly Acupuncture Treatment|Veterans with diagnosed symptoms of Gulf War Illness were randomized to six months of biweekly acupuncture treatments.
826467|NCT01305811|O2|Outcome|Wait List|"Wait list for 2 months.~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
826468|NCT01305811|O1|Outcome|Bi-weekly Acupuncture Treatment|"Bi-weekly acupuncture treatment~Acupuncture: Sterile insertive needles are applied by licensed, experienced practitioners."
826469|NCT01305811|O2|Outcome|Wait List Then Weekly Acupuncture|group mean SF-36 P score at 6 months
826470|NCT01305811|O1|Outcome|Bi-Weekly Acupuncture|group mean SF-36 P score at 6 months
826471|NCT01305811|E2|Reported Event|Wait List|"Wait list for 2 months followed by 4 months of weekly acupuncture~No Adverse events were reported in the Wait list group"
826497|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826472|NCT01305811|E1|Reported Event|Bi-Weekly Acupuncture|"Bi-Weekly Acupuncture for 6 months~1 serious unexpected adverse event in the biweekly group: Subject’s practitioner was told by subject of a suicide attempt. Case was reviewed and the medical monitor and identified as needing follow up. Subject was hospitalized for observation, released to his daughter’s custody. Both the VA and the Crisis Center were in touch with him on Feb 27th and are making arrangements to take him, (patient reported), either in patient or into a program. He had a follow-up appointment Feb 28th at the VA and he was hospitalized at this time and is currently hospitalized.~The practitioner will also follow up with subject’s PCP."
826473|NCT01305772|B3|Baseline|Total|Total of all reporting groups
826474|NCT01305772|B2|Baseline|Surgery|Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration
826475|NCT01305772|B1|Baseline|Radiation Therapy|Patients who underwent radiation therapy only, in conjunction with panitumumab therapy
826476|NCT01305772|P2|Participant Flow|Surgery|"Patients who underwent surgery after research PET/CT scans and subsequent radiation therapy with panitumumab administration~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT.~Surgery : Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site)."
826477|NCT01305772|P1|Participant Flow|Radiation Therapy|"Patients who underwent radiation therapy only, in conjunction with panitumumab therapy.~Radiation Therapy : Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.~Panitumumab : Single dose Panitumumab 9mg/kg IV for a total of 3 doses (if tolerated). Dose #1 is to be administered prior to RT for RT arm. Within the surgery arm, second and third doses of panitumumab were administered after surgery during weeks 1 & 4 of RT. Within the RT arm, second and third doses will be administered at weeks 1 & 4 during RT."
826478|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
826479|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
826480|NCT01305772|O1|Outcome|Overall Study|Patients from both the Surgery and RT arms will be combined in reporting primary and secondary outcome results, as one arm only contains 1 subject. Statistical uncertainty cannot be measured about 1 subject.
826481|NCT01305772|E2|Reported Event|Surgery|Surgery after research PET/CT scans and subsequent radiation therapy with panitumumab therapy.
826482|NCT01305772|E1|Reported Event|Radiation Therapy|Radiation therapy with panitumumab therapy.
826483|NCT01305655|B1|Baseline|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values."
826484|NCT01305655|P1|Participant Flow|Glucarpidase Arm|In children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
826485|NCT01305655|O1|Outcome|Glucarpidase Arm|47 children treated with high dose MTX (HDMTX) according to the NOPHO ALL 2008 protocol, Glucarpidase was used in case of predefined toxic MTX values at defined time points in combination with decreased renal function.
826486|NCT01305655|E1|Reported Event|Glucarpidase Arm|"In the NOPHO ALL-2008 protocol patients with delayed methotrexate elimination (DME) in high-dose methotrexate treatments should be given Glucarpidase (50 ie/kg) with-in 60 hours from start of the methotrexate treatment.~Glucarpidase: Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.~No serious effect reported."
826487|NCT01305577|B4|Baseline|Total|Total of all reporting groups
826488|NCT01305577|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826489|NCT01305577|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826490|NCT01305577|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826491|NCT01305577|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826492|NCT01305577|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826493|NCT01305577|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826494|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826495|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826496|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826840|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
826498|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826499|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826500|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826501|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826502|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826503|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826504|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826505|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826506|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826507|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826508|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826509|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826510|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826511|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826512|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826513|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826514|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826515|NCT01305577|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826516|NCT01305577|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826517|NCT01305577|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826518|NCT01305577|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826519|NCT01305577|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826520|NCT01305577|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
826521|NCT01305564|B1|Baseline|Baseline Characteristics|All treated with Denali filter.
826522|NCT01305564|P1|Participant Flow|Denali Inferior Vena Cava Filter|"All subjects enrolled will receive the Denali vena cava filter.~Denali inferior vena cava filter: The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube."
826523|NCT01305564|O1|Outcome|Filter Penetration at Retrieval|
826524|NCT01305564|O1|Outcome|Filter Penetration at Placement|
826525|NCT01305564|O1|Outcome|Filter Tilt|At Retrieval
826526|NCT01305564|O1|Outcome|Filter Tilt|At Implant
826527|NCT01305564|O1|Outcome|Filter Migration >2 cm|
826528|NCT01305564|O1|Outcome|Filter Fracture|
826529|NCT01305564|O1|Outcome|New or Worsening DVT|
826530|NCT01305564|O1|Outcome|Recurrent PE|
826531|NCT01305564|O1|Outcome|Clinical Success of Retrieval|
826532|NCT01305564|O1|Outcome|Technical Success of Retrieval|
826533|NCT01305564|O1|Outcome|Clinical Success of Placement|
826534|NCT01305564|O1|Outcome|Technical Success of Placement|Primary implant endpoint
826535|NCT01305564|E1|Reported Event|Serious Adverse Events|"Serious Adverse Events are reported for all 200 subjects and all serious events are reported.~Non-serious adverse events are reported when the reported threshold for an event is at 5% or higher. This represents 175 subjects and not 200 for non-serious events."
826536|NCT01305473|B1|Baseline|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826537|NCT01305473|P1|Participant Flow|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826538|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826539|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826540|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826541|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826542|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826543|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826544|NCT01305473|O1|Outcome|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826545|NCT01305473|E1|Reported Event|Sepramesh Group|Subjects who underwent laparoscopic ventral hernia repair utilizing Bard Sepramesh Composite at least 12 months prior to enrollment.
826546|NCT01305408|B3|Baseline|Total|Total of all reporting groups
826547|NCT01305408|B2|Baseline|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826548|NCT01305408|B1|Baseline|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826549|NCT01305408|P2|Participant Flow|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826550|NCT01305408|P1|Participant Flow|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826551|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826552|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826553|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826554|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826555|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826556|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826557|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826558|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826559|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826560|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826561|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826562|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826563|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826564|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826565|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826566|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826567|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826568|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826569|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826570|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826571|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826572|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826573|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826574|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826575|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826576|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826577|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826578|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826579|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826580|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826581|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826582|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826583|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826584|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826585|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826586|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826587|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826588|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826589|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826590|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826591|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826592|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826593|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826594|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826595|NCT01305408|O2|Outcome|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826596|NCT01305408|O1|Outcome|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826597|NCT01305408|E2|Reported Event|Placebo|Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks.
826598|NCT01305408|E1|Reported Event|Armodafinil 150 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
826599|NCT01305265|B3|Baseline|Total|Total of all reporting groups
826600|NCT01305265|B2|Baseline|Intervention Group|Endotracheal tube cuff inflated using the inflate & palpate technique. The cuff pressure then was adjusted to 22-26cmH2O within 15min after endotracheal intubation by trained study staff.
826601|NCT01305265|B1|Baseline|Control Group|Endotracheal tube cuff inflated using the inflate & palpate technique
826602|NCT01305265|P2|Participant Flow|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
826603|NCT01305265|P1|Participant Flow|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
826604|NCT01305265|O2|Outcome|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
826605|NCT01305265|O1|Outcome|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
826606|NCT01305265|E2|Reported Event|Intervention Group|Endotracheal tube cuff will be inflated using the inflate & palpate technique. The cuff pressure will be adjusted to 22-26cmH2O within 15min after intubation by trained study staff.
826607|NCT01305265|E1|Reported Event|Control Group|Endotracheal tube cuff will be inflated using the inflate&palpate technique
826608|NCT01305252|B3|Baseline|Total|Total of all reporting groups
826609|NCT01305252|B2|Baseline|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826610|NCT01305252|B1|Baseline|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826611|NCT01305252|P2|Participant Flow|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826612|NCT01305252|P1|Participant Flow|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826613|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826614|NCT01305252|O1|Outcome|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826615|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826709|NCT01304693|P5|Participant Flow|Lucentis|Single intravitreal injection with 6-month follow-up
826616|NCT01305252|O1|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826617|NCT01305252|O2|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826618|NCT01305252|O1|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826619|NCT01305252|O2|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826620|NCT01305252|O1|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826621|NCT01305252|O2|Outcome|Tadalafil Alone|"Tadalafil 40mg QD~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826622|NCT01305252|O1|Outcome|Tadalafil and Treprostinil Inhalations|"Inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~Tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826623|NCT01305252|E2|Reported Event|Tadalafil and Treprostinil Inhalations|"inhaled treprostinil: Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826624|NCT01305252|E1|Reported Event|Tadalafil Alone|"tadalafil 40mg QD~tadalafil: tadalafil 20mg QD PO increasing to 40mg QD as tolerated"
826625|NCT01305239|B1|Baseline|Exemestane|25 mg oral tablet once a day
826626|NCT01305239|P1|Participant Flow|Exemestane|25 mg oral tablet once a day
826627|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
826628|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
826629|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
826630|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
826631|NCT01305239|O1|Outcome|Exemestane|25 mg oral tablet once a day
826632|NCT01305239|E1|Reported Event|Exemestane|25 mg oral tablet once a day
826633|NCT01305200|B4|Baseline|Total|Total of all reporting groups
826634|NCT01305200|B3|Baseline|Arm III (Enrolled Not Randomized)|Site not able to randomize.
826635|NCT01305200|B2|Baseline|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826636|NCT01305200|B1|Baseline|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826637|NCT01305200|P3|Participant Flow|Arm III (Enrolled But Not Randomized)|Site not randomized
826638|NCT01305200|P2|Participant Flow|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826837|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826639|NCT01305200|P1|Participant Flow|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826640|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826641|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826642|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826643|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826644|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826645|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826665|NCT01305200|E1|Reported Event|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826646|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826647|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826648|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826649|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826650|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826651|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826652|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826653|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826654|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826655|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826656|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826657|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826838|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
826658|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826659|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826660|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826661|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826662|NCT01305200|O2|Outcome|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826663|NCT01305200|O1|Outcome|Arm I (Placebo)|"Patients rinse and gargle with placebo over 1 minute QID beginning the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~placebo: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826664|NCT01305200|E2|Reported Event|Arm II (Supersaturated Calcium Phosphate Rinse)|"Patients rinse and gargle with supersaturated calcium phosphate rinse over 1 minute QID beginning on the first day (about day -7) of the conditioning regimen. Treatment continues until day 20 post-transplantation.~supersaturated calcium phosphate rinse: Mouth rinse~questionnaire administration: Ancillary studies~quality-of-life assessment: Ancillary studies"
826667|NCT01305044|B2|Baseline|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826668|NCT01305044|B1|Baseline|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826669|NCT01305044|P2|Participant Flow|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826670|NCT01305044|P1|Participant Flow|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826671|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826672|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826673|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826674|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826675|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826741|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826742|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826676|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826677|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826678|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826679|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826680|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826681|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826710|NCT01304693|P4|Participant Flow|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
826711|NCT01304693|P3|Participant Flow|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
826712|NCT01304693|P2|Participant Flow|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
826713|NCT01304693|P1|Participant Flow|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
826682|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826683|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826684|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826685|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826686|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826687|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826688|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826689|NCT01305044|O2|Outcome|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826690|NCT01305044|O1|Outcome|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826691|NCT01305044|E2|Reported Event|Health Education|Health Education Classes : The Health Education classes serve as an attention control group, were led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
826743|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826744|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826692|NCT01305044|E1|Reported Event|Tai Chi Chih|Tai Chi Chih : Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
826693|NCT01304966|B1|Baseline|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
826694|NCT01304966|P1|Participant Flow|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
826695|NCT01304966|O2|Outcome|HPV 11|Children with recurrent respiratory papillomatosis from HPV 11
826696|NCT01304966|O1|Outcome|HPV 6|Children with recurrent respiratory papillomatosis from HPV 6
826697|NCT01304966|O1|Outcome|Children With Recurrent Respiratory Papillomatosis|Distribution of Human papillomavirus(HPV) genotypes identified in the biopsy
826698|NCT01304966|E1|Reported Event|Children With Recurrent Respiratory Papillomatosis|Children hospitalized with recurrent respiratory papillomatosis who underwent biopsy
826699|NCT01304706|B1|Baseline|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
826700|NCT01304706|P1|Participant Flow|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
826701|NCT01304706|O1|Outcome|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
826702|NCT01304706|E1|Reported Event|Fluocinolone Acetonide|Fluocinolone Acetonide: 0.2 μg/day
826703|NCT01304693|B6|Baseline|Total|Total of all reporting groups
826704|NCT01304693|B5|Baseline|Lucentis|Single intravitreal injection with 6-month follow-up
826705|NCT01304693|B4|Baseline|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
826706|NCT01304693|B3|Baseline|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
826707|NCT01304693|B2|Baseline|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
826714|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
826715|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
826716|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
826717|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
826718|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
826719|NCT01304693|O5|Outcome|Lucentis|Single intravitreal injection with 6-month follow-up
826720|NCT01304693|O4|Outcome|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
826721|NCT01304693|O3|Outcome|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
826722|NCT01304693|O2|Outcome|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
826723|NCT01304693|O1|Outcome|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
826724|NCT01304693|E5|Reported Event|Lucentis|Single intravitreal injection with 6-month follow-up
826725|NCT01304693|E4|Reported Event|ESBA1008 Dose D|Single intravitreal injection with 6-month follow-up
826726|NCT01304693|E3|Reported Event|ESBA1008 Dose C|Single intravitreal injection with 6-month follow-up
826727|NCT01304693|E2|Reported Event|ESBA1008 Dose B|Single intravitreal injection with 6-month follow-up
826728|NCT01304693|E1|Reported Event|ESBA1008 Dose A|Single intravitreal injection with 6-month follow-up
826729|NCT01304641|B3|Baseline|Total|Total of all reporting groups
826730|NCT01304641|B2|Baseline|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826731|NCT01304641|B1|Baseline|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826732|NCT01304641|P2|Participant Flow|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826733|NCT01304641|P1|Participant Flow|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826734|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826735|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826736|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826737|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826738|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826739|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826740|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826745|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826746|NCT01304641|O2|Outcome|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826747|NCT01304641|O1|Outcome|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826748|NCT01304641|E2|Reported Event|Simvastatin|Participants who had been on simvastatin with dose strength ranging from 5 mg to 80 mg were observed for 12 months and a 3 month follow-up period.
826749|NCT01304641|E1|Reported Event|Atorvastatin|Participants who had been on atorvastatin with dose strength ranging from 10 milligram (mg) to 80 mg were observed for 12 months and a 3 month follow-up period.
826750|NCT01304589|B1|Baseline|Milnacipram|Open-label study of milnacipram. 50 to 200 milligrams orally per day. Tablets were taken in the morning during an 18-week clinical trial.
826751|NCT01304589|P1|Participant Flow|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
826752|NCT01304589|O1|Outcome|Milnacipram|Crossover study
826753|NCT01304589|O1|Outcome|Milnacipram|Crossover study
826754|NCT01304589|O1|Outcome|Milnacipran|Milnacipran: 6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose)for 12 weeks - total treatment period is 18 weeks
826755|NCT01304589|O1|Outcome|Milnacipram|open-label study
826756|NCT01304589|E1|Reported Event|Milnacipram|Crossover study
826757|NCT01304329|B1|Baseline|Study Overall|This was a randomised, 3-period, crossover trial. The trial was open label. The three treatments were separated by a washout period of at least 7 days.
826758|NCT01304329|P6|Participant Flow|Empa Plus Sim / Simvastatin Alone / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg"
826759|NCT01304329|P5|Participant Flow|Empa Plus Sim / Empa Alone / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg"
826760|NCT01304329|P4|Participant Flow|Simvastatin Alone / Empa Plus Sim / Empa Alone|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of empagliflozin 25mg"
826804|NCT01304238|P8|Participant Flow|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826761|NCT01304329|P3|Participant Flow|Simvastatin Alone / Empa Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
826762|NCT01304329|P2|Participant Flow|Empa Alone / Empa Plus Sim / Simvastatin Alone|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of empagliflozin 25mg together with 40mg simvastatin~A single dose of simvastatin 40mg"
826763|NCT01304329|P1|Participant Flow|Empa Alone / Simvastatin Alone / Empa Plus Sim|"Patients were administered three treatments in the following order:~A single dose of empagliflozin 25mg~A single dose of simvastatin 40mg~A single dose of empagliflozin 25mg together with 40mg simvastatin"
826764|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
826765|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
826766|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
826767|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
826768|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
826769|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
826770|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
826771|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
826772|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
826773|NCT01304329|O1|Outcome|Simvastatin Alone|40 mg simvastatin alone
826774|NCT01304329|O2|Outcome|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
826775|NCT01304329|O1|Outcome|Empa Alone|25mg empagliflozin (empa) alone
826776|NCT01304329|E3|Reported Event|Empa Plus Sim|25 mg empagliflozin (empa) together with 40 mg simvastatin (sim)
826777|NCT01304329|E2|Reported Event|Simvastatin Alone|40 mg simvastatin alone
826778|NCT01304329|E1|Reported Event|Empa Alone|25mg empagliflozin (empa) alone
826779|NCT01304277|B1|Baseline|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826780|NCT01304277|P1|Participant Flow|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826781|NCT01304277|O3|Outcome|Overall|Overall number of patients who experienced adverse events during the course of REP-082 study.
826782|NCT01304277|O2|Outcome|Replagal AF|Patients received 7 EOW infusions of treatment with Replagal AF from week 2 to week 14 in REP-082.
826783|NCT01304277|O1|Outcome|Replagal RB|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082.
826784|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826785|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826836|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826786|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826787|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826788|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826789|NCT01304277|O1|Outcome|Replagal® (0.2 mg/kg, EOW)|Patients who had received Replagal RB for at least 26 weeks prior to entering the study REP-082, received 1 dose of Replagal RB at baseline before switching to Replagal AF. They then received 14 weeks of treatment with Replagal AF.
826790|NCT01304277|E1|Reported Event|Replagal® (0.2 mg/kg, IV, EOW)|Overall patients that participated in REP-082
826791|NCT01304238|B11|Baseline|Total|Total of all reporting groups
826792|NCT01304238|B10|Baseline|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826793|NCT01304238|B9|Baseline|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826794|NCT01304238|B8|Baseline|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826795|NCT01304238|B7|Baseline|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826796|NCT01304238|B6|Baseline|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826797|NCT01304238|B5|Baseline|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826798|NCT01304238|B4|Baseline|Fondaparinux|Participants treated with fondaparinux after HIT II
826799|NCT01304238|B3|Baseline|Danaparoid|Participants treated with danaparoid after HIT II
826800|NCT01304238|B2|Baseline|Lepirudin|Participants treated with lepirudin after HIT II
826801|NCT01304238|B1|Baseline|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826802|NCT01304238|P10|Participant Flow|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826803|NCT01304238|P9|Participant Flow|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826805|NCT01304238|P7|Participant Flow|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826806|NCT01304238|P6|Participant Flow|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826807|NCT01304238|P5|Participant Flow|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826808|NCT01304238|P4|Participant Flow|Fondaparinux|Participants treated with fondaparinux after HIT II
826809|NCT01304238|P3|Participant Flow|Danaparoid|Participants treated with danaparoid after HIT II
826810|NCT01304238|P2|Participant Flow|Lepirudin|Participants treated with lepirudin after HIT II
826811|NCT01304238|P1|Participant Flow|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826812|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826813|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826814|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826815|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826816|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826817|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826818|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
826819|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
826820|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
826821|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826822|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826823|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826824|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826825|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826826|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826827|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826828|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
826829|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
826830|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
826831|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826832|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826833|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826834|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826835|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826841|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826842|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826843|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826844|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826845|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826846|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826847|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826848|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
826849|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
826850|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
826851|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826852|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826853|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826854|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826855|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826856|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826857|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826858|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
826859|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
826860|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
826861|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826862|NCT01304238|O10|Outcome|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826863|NCT01304238|O9|Outcome|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826864|NCT01304238|O8|Outcome|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826865|NCT01304238|O7|Outcome|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826866|NCT01304238|O6|Outcome|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826867|NCT01304238|O5|Outcome|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826868|NCT01304238|O4|Outcome|Fondaparinux|Participants treated with fondaparinux after HIT II
826869|NCT01304238|O3|Outcome|Danaparoid|Participants treated with danaparoid after HIT II
826870|NCT01304238|O2|Outcome|Lepirudin|Participants treated with lepirudin after HIT II
826871|NCT01304238|O1|Outcome|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826872|NCT01304238|E10|Reported Event|Argatroban/Danaparoid/Fondaparinux|Participants treated with argatroban, danaparoid, and fondaparinux after HIT II
826873|NCT01304238|E9|Reported Event|Danaparoid/Fondaparinux/Lepirudin|Participants treated with danaparoid, fondaparinux, and lepirudin after HIT II
826874|NCT01304238|E8|Reported Event|Danaparoid/Lepirudin|Participants treated with danaparoid and lepirudin after HIT II
826875|NCT01304238|E7|Reported Event|Danaparoid/Fondaparinux|Participants treated with danaparoid and fondaparinux after HIT II
826876|NCT01304238|E6|Reported Event|Danaparoid/Argatroban|Participants treated with danaparoid and argatroban after HIT II
826877|NCT01304238|E5|Reported Event|Argatroban/Fondaparinux|Participants treated with argatroban and fondaparinux after HIT II
826878|NCT01304238|E4|Reported Event|Fondaparinux|Participants treated with fondaparinux after HIT II
826879|NCT01304238|E3|Reported Event|Danaparoid|Participants treated with danaparoid after HIT II
826880|NCT01304238|E2|Reported Event|Lepirudin|Participants treated with lepirudin after HIT II
826881|NCT01304238|E1|Reported Event|Argatroban|Participants treated with argatroban after Heparin-induced thrombocytopenia Type-II (HIT II)
826882|NCT01304147|B1|Baseline|Participants Treated|
826883|NCT01304147|P2|Participant Flow|Placebo, Then Ketamine|placebo: Single dose of saline (0.9% saline solution) intranasal for 7 days in first intervention, then Ketamine 50mg in second intervention.
826884|NCT01304147|P1|Participant Flow|Ketamine Then Placebo|Ketamine: A single dose of intranasal ketamine up to 50 mg for 7 days in first intervention. Then Placebo for 7 days in 2nd intervention.
826885|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
826886|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
826887|NCT01304147|O2|Outcome|Placebo|placebo: Single dose of saline intranasal
826888|NCT01304147|O1|Outcome|Ketamine|Ketamine: A single dose of intranasal ketamine up to 50 mg
826889|NCT01304147|E2|Reported Event|Placebo|
826890|NCT01304147|E1|Reported Event|Ketamine|
826891|NCT01304082|B1|Baseline|All Study Participants|All study participants
826892|NCT01304082|P5|Participant Flow|A, L, C|alkalinized lidocaine, lidocaine, control
826893|NCT01304082|P4|Participant Flow|A, C, L|alkalinized lidocaine, control, lidocaine
826894|NCT01304082|P3|Participant Flow|L, C, A|lidocaine, control, alkalinized lidocaine
826895|NCT01304082|P2|Participant Flow|C, A, L|control, alkalinized lidocaine, lidocaine
826896|NCT01304082|P1|Participant Flow|C, L, A|control, lidocaine, alkalinized lidocaine
826897|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
826898|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
826899|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
826900|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
826901|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
826902|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
826903|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
826904|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
826905|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
826906|NCT01304082|O3|Outcome|Alkalinized Lidocaine|alkalinized lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
826907|NCT01304082|O2|Outcome|Lidocaine|Lidocaine: 1 ml subcutaneous injection of 0.9% lidocaine, given once
826908|NCT01304082|O1|Outcome|Normal Saline|normal saline: 1 ml subcutaneous injection 0.9% sodium chloride, given once
826909|NCT01304082|E3|Reported Event|Alkalinized Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
826910|NCT01304082|E2|Reported Event|Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine, given once
826911|NCT01304082|E1|Reported Event|Normal Saline|1 ml subcutaneous injection 0.9% sodium chloride, given once
826912|NCT01303861|B6|Baseline|Total|Total of all reporting groups
826913|NCT01303861|B5|Baseline|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
826914|NCT01303861|B4|Baseline|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826951|NCT01303835|E1|Reported Event|Naltrexone|Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.
826915|NCT01303861|B3|Baseline|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
826916|NCT01303861|B2|Baseline|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
826917|NCT01303861|B1|Baseline|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826918|NCT01303861|P4|Participant Flow|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826919|NCT01303861|P3|Participant Flow|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
826920|NCT01303861|P2|Participant Flow|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
826921|NCT01303861|P1|Participant Flow|Varenicline|"This group will consist of smokers who, based on smoking behavior, Do NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826922|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826952|NCT01303744|B5|Baseline|Total|Total of all reporting groups
826953|NCT01303744|B4|Baseline|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
826954|NCT01303744|B3|Baseline|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
826955|NCT01303744|B2|Baseline|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
826956|NCT01303744|B1|Baseline|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
826923|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
826924|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
826925|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826926|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826927|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
826928|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
826984|NCT01303627|E2|Reported Event|Control Group|Remifentanil stopped at the end of the surgery
826929|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826930|NCT01303861|O4|Outcome|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826957|NCT01303744|P4|Participant Flow|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
826958|NCT01303744|P3|Participant Flow|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
826959|NCT01303744|P2|Participant Flow|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
826960|NCT01303744|P1|Participant Flow|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
826931|NCT01303861|O3|Outcome|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
826932|NCT01303861|O2|Outcome|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
826933|NCT01303861|O1|Outcome|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826934|NCT01303861|E5|Reported Event|Dropped Prior to Condition Assignment|These subjects discontinued study participation prior to being assigned to a condition.
826935|NCT01303861|E4|Reported Event|Varenicline With Bupropion|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline in combination with bupropion.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.~Bupropion: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826936|NCT01303861|E3|Reported Event|Nicotine Patches With Nicotine Inhaler|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will continue to receive nicotine patches and will receive a nicotine inhaler to use as needed after their quit date.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week~Nicotine Inhaler: Nicotine inhaler to use as needed after quit date"
826937|NCT01303861|E2|Reported Event|Nicotine Patches Only|"This group will consist of smokers who, based on smoking behavior, respond favorably to pre-cessation nicotine patches(assessed at Session P2). They will continue to receive only nicotine patches.~Nicotine patches: Nicotine Replacement Therapy Groups:~For smokers with high baseline CO: 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.~Varenicline and varenicline in combination with bupropion groups:~For smokers with high baseline CO: 42 mg/24 h for 1 week~For smokers with low baseline CO: 21 mg/24 h for 1 week"
826938|NCT01303861|E1|Reported Event|Varenicline|"This group will consist of smokers who, based on smoking behavior, DO NOT respond favorably to pre-cessation nicotine patches (assessed at Session P2). They will receive varenicline.~Varenicline: For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks."
826939|NCT01303835|B3|Baseline|Total|Total of all reporting groups
826940|NCT01303835|B2|Baseline|Placebo|Randomized patients received placebo to be taken every night before bed.
826941|NCT01303835|B1|Baseline|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
826942|NCT01303835|P2|Participant Flow|Placebo|Randomized patients received placebo to be taken every night before bed.
826943|NCT01303835|P1|Participant Flow|Naltrexone|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
826944|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
826945|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
826946|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
826947|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
826948|NCT01303835|O2|Outcome|Placebo|Randomized patients received placebo to be taken every night before bed.
826949|NCT01303835|O1|Outcome|Low Dose Naltrexone (LDN)|Randomized patients received 4.5 mg naltrexone to be taken every night before bed.
826950|NCT01303835|E2|Reported Event|Placebo|Randomized patients received placebo to be taken every night before bed.
826961|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
826962|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
826963|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
826964|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
826965|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
826966|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
826967|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
826968|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
826969|NCT01303744|O4|Outcome|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
826970|NCT01303744|O3|Outcome|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
826971|NCT01303744|O2|Outcome|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
826972|NCT01303744|O1|Outcome|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
826973|NCT01303744|E4|Reported Event|Placebo|"placebo, oral tablet, multidose~Placebo: oral tablet, once a day in the morning for 12 weeks"
826974|NCT01303744|E3|Reported Event|CHF 5074 3x|"oral tablet, multidose~CHF 5074 3x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks"
826975|NCT01303744|E2|Reported Event|CHF 5074 2x|"oral tablet, multidose~CHF 5074 2x: oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks"
826976|NCT01303744|E1|Reported Event|CHF 5074 1x|"oral tablet, multidose~CHF 5074 1x: oral tablet, 1x, once a day in the morning for 12 weeks"
826977|NCT01303627|B3|Baseline|Total|Total of all reporting groups
826978|NCT01303627|B2|Baseline|Control|Control:Remifentanil stopped at the end of the surgery
826979|NCT01303627|B1|Baseline|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
826980|NCT01303627|P2|Participant Flow|Control|Control:Remifentanil stopped at the end of the surgery
826981|NCT01303627|P1|Participant Flow|Ultiva,Remifentanil,Opioid,Analgesic|Remifentanil:1.5ng/ml remifentanil infusion maintained at the end of the surgery
826982|NCT01303627|O2|Outcome|Control Group|Remifentanil stopped at the and of the surgery
826983|NCT01303627|O1|Outcome|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
826985|NCT01303627|E1|Reported Event|Remifentanil Group|remifentanil group (group R) TCI effect-site of remifentanil at 1.5 ng/ml was continued until cLMA removal
826986|NCT01303510|B3|Baseline|Total|Total of all reporting groups
826987|NCT01303510|B2|Baseline|Group B|Elderly subjects aged over 60 years
826988|NCT01303510|B1|Baseline|Group A|Adults from 18 to 60 years old inclusive
826989|NCT01303510|P2|Participant Flow|Group B|Elderly subjects aged over 60 years
826990|NCT01303510|P1|Participant Flow|Group A|Adults from 18 to 60 years old inclusive
826991|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
826992|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
826993|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
826994|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
826995|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
826996|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
826997|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
826998|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
826999|NCT01303510|O2|Outcome|Group B|Elderly subjects aged over 60 years
827000|NCT01303510|O1|Outcome|Group A|Adults from 18 to 60 years old inclusive
827001|NCT01303510|E2|Reported Event|Group B|Elderly subjects aged over 60 years
827002|NCT01303510|E1|Reported Event|Group A|Adults from 18 to 60 years old inclusive
827003|NCT01303445|B1|Baseline|Entire Study Population|
827004|NCT01303445|P2|Participant Flow|CDAB Sequence|Omeprazole/Aggrenox+Omeprazole/Aggrenox/Aggrenox+Omeprazole
827005|NCT01303445|P1|Participant Flow|ABCD Sequence|Aggrenox/Aggrenox+Omeprazole/Omeprazole/Aggrenox+Omeprazole
827006|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
827007|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
827008|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
827009|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
827010|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
827011|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
827012|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
827071|NCT01303224|B5|Baseline|Total|Total of all reporting groups
827013|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
827014|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
827015|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
827016|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
827017|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
827018|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
827019|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
827020|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
827021|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
827022|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
827023|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
827024|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
827025|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
827026|NCT01303445|O4|Outcome|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
827027|NCT01303445|O3|Outcome|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
827028|NCT01303445|O2|Outcome|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
827029|NCT01303445|O1|Outcome|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
827030|NCT01303445|E4|Reported Event|Aggrenox BID Plus Omeprazole QD Following Omeprazole Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Omeprazole alone
827031|NCT01303445|E3|Reported Event|Omeprazole Alone QD|Omeprazole 40mg QD (once daily)
827032|NCT01303445|E2|Reported Event|Aggrenox BID Plus Omeprazole QD Following Aggrenox Alone|Aggrenox 25mg/200mg capsules BID plus Omeprazole 40mg QD (once daily) following Aggrenox alone
827033|NCT01303445|E1|Reported Event|Aggrenox Alone BID|Aggrenox (aspirin/extended release dipyridamole) 25mg/200mg capsules BID (twice daily)
827034|NCT01303406|B3|Baseline|Total|Total of all reporting groups
827035|NCT01303406|B2|Baseline|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827116|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827036|NCT01303406|B1|Baseline|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827037|NCT01303406|P2|Participant Flow|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827038|NCT01303406|P1|Participant Flow|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827039|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827040|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827072|NCT01303224|B4|Baseline|Placebo|oral tablet, once daily
827073|NCT01303224|B3|Baseline|Ibodutant 10 mg|oral tablet, once daily
827074|NCT01303224|B2|Baseline|Ibodutant 3 mg|oral tablet, once daily
827041|NCT01303406|O2|Outcome|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827042|NCT01303406|O1|Outcome|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827043|NCT01303406|E2|Reported Event|Idebenone|"Following the body weight, patients will be allocated to one of the following regimen:~Idebenone Patients < 45 kg - 3 tablets 3 times a day with meals~Idebenone Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827044|NCT01303406|E1|Reported Event|Placebo|"Following the body weight, patients will be allocated to one of the following regimen:~Placebo Patients < 45 kg - 3 tablets 3 times a day with meals~Placebo Patients > 45 kg - 5 tablets 3 times a day with meals~Idebenone: All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals)."
827045|NCT01303380|B1|Baseline|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827046|NCT01303380|P1|Participant Flow|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new Hyper-IgD with periodic fever syndrome (HIDS) flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827117|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827118|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827119|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827120|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827121|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827047|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827048|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827049|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827050|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827051|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827052|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827053|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827054|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827055|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827056|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827122|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
827057|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827058|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827059|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827060|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827061|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827062|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827063|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827064|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827065|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827066|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827123|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
828444|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
827067|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827068|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827069|NCT01303380|O1|Outcome|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator's discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827070|NCT01303380|E1|Reported Event|Canakinumab|Participants received body weight stratified dosage of canakinumab (4 mg/kg for participants less than or equal to (≤) 40 kg or 300 mg for participants more than (>) 40 kg) as starting dose s.c. injection every 6 weeks during 6 months of treatment. The dose was escalated to additional 150 mg (2 mg/kg for participants ≤40 kg) dose at the moment of flare, and 450 mg (6 mg/kg for participants ≤40 kg) every 6 weeks, thereafter starting at Week 6 in participants who experienced a new HIDS flare between baseline and Week 4 as per investigator’s discretion. If the flare occurred between Weeks 5-6, the participants received rescue medication and waited up to Week 6 to receive a total of 450 mg of canakinumab.
827077|NCT01303224|P3|Participant Flow|Ibodutant 10 mg|oral tablet, once daily
827078|NCT01303224|P2|Participant Flow|Ibodutant 3 mg|oral tablet, once daily
827079|NCT01303224|P1|Participant Flow|Ibodutant 1 mg|oral tablet, once daily
827080|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
827081|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
827082|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
827083|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
827084|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
827085|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
827086|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
827087|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
827088|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
827089|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
827090|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
827091|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
827092|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
827093|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
827094|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
827095|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
827096|NCT01303224|O4|Outcome|Placebo|oral tablet, once daily
827097|NCT01303224|O3|Outcome|Ibodutant 10 mg|oral tablet, once daily
827098|NCT01303224|O2|Outcome|Ibodutant 3 mg|oral tablet, once daily
827099|NCT01303224|O1|Outcome|Ibodutant 1 mg|oral tablet, once daily
827100|NCT01303224|E4|Reported Event|Placebo|oral tablet, once daily
827101|NCT01303224|E3|Reported Event|Ibodutant 10 mg|oral tablet, once daily
827102|NCT01303224|E2|Reported Event|Ibodutant 3 mg|oral tablet, once daily
827103|NCT01303224|E1|Reported Event|Ibodutant 1 mg|oral tablet, once daily
827104|NCT01303159|B1|Baseline|Radiofrequency Probe (ENDOHPB)|Intervention: The EndoHPB Radiofrequency probe
827105|NCT01303159|P1|Participant Flow|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
827106|NCT01303159|O1|Outcome|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
827107|NCT01303159|O1|Outcome|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
827108|NCT01303159|E1|Reported Event|Radiofrequency Probe (ENDOHPB)|"Intervention:~The EndoHPB Radiofrequency probe"
827109|NCT01302938|B3|Baseline|Total|Total of all reporting groups
827110|NCT01302938|B2|Baseline|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827111|NCT01302938|B1|Baseline|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827112|NCT01302938|P2|Participant Flow|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827113|NCT01302938|P1|Participant Flow|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827114|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827115|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827124|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827125|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
827126|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
827127|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
827128|NCT01302938|O1|Outcome|Entire Study Population|Includes all participants who received either tolterodine 4 mg extended release capsule once daily or matching placebo for 12 weeks.
827129|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827130|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827131|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827132|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827133|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827134|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827135|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827136|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827137|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827138|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827139|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827140|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827141|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827142|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827143|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827144|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827145|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827146|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827147|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827148|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827149|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827150|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827151|NCT01302938|O2|Outcome|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827152|NCT01302938|O1|Outcome|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827153|NCT01302938|E2|Reported Event|Placebo|Placebo matched to tolterodine 4 mg extended release capsule once daily for 12 weeks.
827154|NCT01302938|E1|Reported Event|Tolterodine|Tolterodine 4 mg extended release capsule once daily for 12 weeks.
827155|NCT01302899|B3|Baseline|Total|Total of all reporting groups
827156|NCT01302899|B2|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
827157|NCT01302899|B1|Baseline|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
827158|NCT01302899|P2|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)/Ram+Ali + HCTZ/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
827159|NCT01302899|P1|Participant Flow|Ramipril (Ram) +HCTZ/Ram+Aliskiren (Ali)+HCTZ/Ram+Ali/Ram|"Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.~Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.~Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.~Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d."
827160|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827161|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827162|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827163|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827164|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827165|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827166|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827167|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827168|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827169|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827170|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827171|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827274|NCT01302483|P1|Participant Flow|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
827172|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827173|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827174|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827175|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827176|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827177|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827178|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827179|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827180|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827181|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827182|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827183|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827184|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827185|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827215|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827186|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827187|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827188|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827189|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827190|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827191|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827192|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827193|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827194|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827195|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827196|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827232|NCT01302743|O1|Outcome|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
827197|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827198|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827199|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827200|NCT01302899|O4|Outcome|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827201|NCT01302899|O3|Outcome|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827202|NCT01302899|O2|Outcome|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827203|NCT01302899|O1|Outcome|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827204|NCT01302899|E4|Reported Event|Ramipril|All patients were treated for 8 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren + placebo to 25 mg HCTZ
827205|NCT01302899|E3|Reported Event|Ramipril+Aliskiren|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 tablets of 150 mg) + placebo to 25 mg HCTZ~*Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827206|NCT01302899|E2|Reported Event|Ramipril+Aliskiren + HCTZ|"All patients were treated for 6 weeks with daily doses of ramipril 10 mg + aliskiren 300 mg* (2 x 150 mg) + HCTZ 25 mg~* Patients were started on aliskiren 150 mg for the 1st week and up-titrated to 300 mg (2 x 150 mg) at the beginning of the 2nd week and continued on this dose until the end of the 6th week of the period"
827207|NCT01302899|E1|Reported Event|Ramipril +HCTZ|All patients were treated for 6 weeks with daily doses of ramipril 10 mg + placebo to 2 x 150 mg aliskiren (300 mg) + HCTZ 25 mg
827208|NCT01302860|B1|Baseline|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827209|NCT01302860|P1|Participant Flow|Canakinumab|Participants received body weight stratified dose of canakinumab 2 milligrams/kilogram (mg/kg) subcutaneous (s.c.) injection every 8 weeks.
827210|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827211|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827212|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827213|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827214|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827216|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827217|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827218|NCT01302860|O1|Outcome|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827219|NCT01302860|E1|Reported Event|Canakinumab|Participants received body weight stratified dose of canakinumab 2 mg/kg s.c. injection every 8 weeks.
827220|NCT01302743|B4|Baseline|Total|Total of all reporting groups
827221|NCT01302743|B3|Baseline|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
827222|NCT01302743|B2|Baseline|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
827223|NCT01302743|B1|Baseline|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
827224|NCT01302743|P3|Participant Flow|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
827225|NCT01302743|P2|Participant Flow|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
827226|NCT01302743|P1|Participant Flow|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
827227|NCT01302743|O3|Outcome|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
827228|NCT01302743|O2|Outcome|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
827229|NCT01302743|O1|Outcome|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
827230|NCT01302743|O3|Outcome|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
827231|NCT01302743|O2|Outcome|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
827275|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
827233|NCT01302743|E3|Reported Event|Cinnulin PF|"Cinnulin PF 500 mg once a day for 90 days~Group 3: Cinnulin PF: Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days."
827234|NCT01302743|E2|Reported Event|Cinnamon Bark|"Cinnamon Bark 1000 mg once a day for 90 days~Group 2: Cinnamon Bark: Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days"
827235|NCT01302743|E1|Reported Event|Metformin|"oral extended-release Metformin 1000 mg once a day for 90 days~Group 1: Metformin: Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days"
827236|NCT01302691|B3|Baseline|Total|Total of all reporting groups
827237|NCT01302691|B2|Baseline|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827238|NCT01302691|B1|Baseline|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827239|NCT01302691|P2|Participant Flow|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827240|NCT01302691|P1|Participant Flow|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827241|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827242|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827243|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827244|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827245|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827246|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827247|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827248|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827249|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827250|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827251|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827252|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827253|NCT01302691|O2|Outcome|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827254|NCT01302691|O1|Outcome|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827255|NCT01302691|E2|Reported Event|L50 + A5|Participants receive tablet, containing 50 mg losartan potassium (L50), and tablet containing 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827256|NCT01302691|E1|Reported Event|L50/H12.5/A5|Participants receive 1 tablet, containing 50 mg losartan potassium (L50), 12.5 mg hydrochlorothiazide (H12.5), and 5 mg amlodipine besylate (A5), orally, once daily, for 8 weeks.
827257|NCT01302548|B3|Baseline|Total|Total of all reporting groups
827258|NCT01302548|B2|Baseline|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
827259|NCT01302548|B1|Baseline|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
827260|NCT01302548|P2|Participant Flow|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
827261|NCT01302548|P1|Participant Flow|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
827262|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
827263|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
827264|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
827265|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
827266|NCT01302548|O2|Outcome|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
827267|NCT01302548|O1|Outcome|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
827268|NCT01302548|E2|Reported Event|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
827269|NCT01302548|E1|Reported Event|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
827270|NCT01302483|B3|Baseline|Total|Total of all reporting groups
827271|NCT01302483|B2|Baseline|Lidocaine Injection|
827272|NCT01302483|B1|Baseline|Kovacaine Nasal Spray|
827273|NCT01302483|P2|Participant Flow|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
827276|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
827277|NCT01302483|O2|Outcome|Lidocaine Injection|Blood Pressure Maximum Change from Baseline
827278|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Blood Pressure Maximum Change from Baseline
827279|NCT01302483|O2|Outcome|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
827280|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
827281|NCT01302483|O2|Outcome|Lidocaine Injection|Duration of Soft Tissue Anesthesia
827282|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Duration of Soft Tissue Anesthesia
827283|NCT01302483|O2|Outcome|Lidocaine Injection|Number of subjects able to complete the dental procedure without rescue
827284|NCT01302483|O1|Outcome|Kovacaine Nasal Spray|Number of subjects able to complete the dental procedure without rescue
827285|NCT01302483|E2|Reported Event|Lidocaine Injection|2% lidocaine HCL with 1:100,000 epinephrine
827286|NCT01302483|E1|Reported Event|Kovacaine Nasal Spray|.6mL 3% tetracaine HCL with 0.05% oxymetazoline HCL
827287|NCT01302444|B3|Baseline|Total|Total of all reporting groups
827288|NCT01302444|B2|Baseline|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827289|NCT01302444|B1|Baseline|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827290|NCT01302444|P2|Participant Flow|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827291|NCT01302444|P1|Participant Flow|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827292|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827293|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827294|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827295|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827296|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827297|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827298|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827299|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827300|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827301|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827302|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827303|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827304|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827305|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827306|NCT01302444|O2|Outcome|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827307|NCT01302444|O1|Outcome|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827308|NCT01302444|E2|Reported Event|Placebo|first 4 weeks for adjusting treprostinil dose, then Placebo for 12 weeks
827309|NCT01302444|E1|Reported Event|Tadalafil|first 4 weeks are for adjusting treprostinil dose, then Tadalafil 40mg daily for 12 weeks, Group is randomly chosen from entire cohort
827310|NCT01302418|B1|Baseline|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
827311|NCT01302418|P1|Participant Flow|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
827312|NCT01302418|O1|Outcome|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
827313|NCT01302418|E1|Reported Event|Symptomatic|Individuals with signs and symptoms of an acute respiratory tract infection where it is suspected that such signs and symptoms are caused by a respiratory virus infection.
827314|NCT01302392|B3|Baseline|Total|Total of all reporting groups
827315|NCT01302392|B2|Baseline|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827316|NCT01302392|B1|Baseline|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827317|NCT01302392|P2|Participant Flow|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827378|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827921|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827318|NCT01302392|P1|Participant Flow|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827319|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827320|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827321|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827322|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827323|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827324|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827325|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827326|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827327|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827357|NCT01302119|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
827328|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827329|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827330|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827331|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827332|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827333|NCT01302392|O2|Outcome|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827334|NCT01302392|O1|Outcome|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827335|NCT01302392|E2|Reported Event|Carfilzomib|Carfilzomib: 20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
827336|NCT01302392|E1|Reported Event|Best Supportive Care|"Best Supportive Care: Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator’s discretion (maximum of 1400 mg per 28-day cycle)."
827337|NCT01302366|B1|Baseline|Sea Cucumber Extract (TBL 12)|"TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.~TBL-12"
827338|NCT01302366|P1|Participant Flow|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
827339|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
827340|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
827341|NCT01302366|O1|Outcome|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
827342|NCT01302366|E1|Reported Event|Sea Cucumber Extract (TBL 12)|TBL12 is administered orally at a dose of 2 units (of 20 mL each) twice a day, in 4-week cycles, until disease progression or there is sign of disease progression.
827343|NCT01302119|B3|Baseline|Total|Total of all reporting groups
827344|NCT01302119|B2|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
827345|NCT01302119|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
827346|NCT01302119|P2|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
827347|NCT01302119|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
827348|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
827349|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
827350|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
827351|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
827352|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
827353|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
827354|NCT01302119|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
827355|NCT01302119|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
827356|NCT01302119|E2|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
827358|NCT01302067|B4|Baseline|Total|Total of all reporting groups
827359|NCT01302067|B3|Baseline|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827360|NCT01302067|B2|Baseline|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827361|NCT01302067|B1|Baseline|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827362|NCT01302067|P3|Participant Flow|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827363|NCT01302067|P2|Participant Flow|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827364|NCT01302067|P1|Participant Flow|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827365|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827366|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827367|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827368|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827369|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827370|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827371|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827372|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827373|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827374|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827375|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827376|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827377|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827379|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827380|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827381|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827382|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827383|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827384|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827385|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827386|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827387|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827388|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827389|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827390|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827391|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827392|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827393|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827394|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827395|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827396|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827397|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827398|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827399|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827400|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827401|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827402|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827403|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827404|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827405|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827406|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827407|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827408|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827409|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827410|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827411|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827412|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827413|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827414|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827415|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827416|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827417|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827418|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827419|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827420|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827421|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827422|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827423|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827424|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827425|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827426|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827427|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827428|NCT01302067|O3|Outcome|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827429|NCT01302067|O2|Outcome|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827430|NCT01302067|O1|Outcome|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827431|NCT01302067|E3|Reported Event|Fesoterodine 8 mg|Participants received one SR tablet with 4 mg fesoterodine for 1 week, followed by dose escalation to 8 mg once daily for 11 weeks.
827432|NCT01302067|E2|Reported Event|Placebo|Participants received one tablet of placebo per day for 12 weeks.
827433|NCT01302067|E1|Reported Event|Fesoterodine 4 Milligram (mg)|Participants received one sustained-release (SR) tablet with 4 mg fesoterodine once daily for 12 weeks.
827434|NCT01302054|B1|Baseline|Entire Study Population|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had <= 50 percent change in UUI episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
827435|NCT01302054|P3|Participant Flow|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827436|NCT01302054|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827437|NCT01302054|P1|Participant Flow|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
827438|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827439|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827440|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827441|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827442|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827443|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827444|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827445|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827446|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827447|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827448|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827449|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827450|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827451|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827452|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827453|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827454|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827455|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827456|NCT01302054|O2|Outcome|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827457|NCT01302054|O1|Outcome|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827458|NCT01302054|O2|Outcome|Fesoterodine: Double-Blind Week 12|Participants who received fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827459|NCT01302054|O1|Outcome|Fesoterodine: Double-Blind Baseline|Participants who were randomized to receive fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827460|NCT01302054|E3|Reported Event|Placebo|Matching placebo tablet orally once daily for 12 weeks during double-blind treatment phase.
827461|NCT01302054|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg sustained release tablet orally once daily for 1 week followed by fesoterodine 8 mg sustained release tablet orally once daily up to Week 12 during double-blind treatment phase.
827462|NCT01302054|E1|Reported Event|Tolterodine|Tolterodine 4 milligram (mg) extended release capsule orally once daily for 2 weeks during open-label run-in phase. Participants who were non-responders in the open-label run-in phase (defined as participants who had less than or equal to [<=] 50 percent change in urgency urinary incontinence [UUI] episodes), were randomized to either fesoterodine or placebo group, in double-blind treatment phase.
827463|NCT01302041|B1|Baseline|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827464|NCT01302041|P1|Participant Flow|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827465|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827466|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827467|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827468|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827469|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827470|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827471|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827496|NCT01301963|P1|Participant Flow|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
827472|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827473|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827474|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827475|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827476|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827477|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827478|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827479|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827480|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827481|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827482|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827483|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827484|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827485|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827486|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827487|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827488|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827489|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827490|NCT01302041|O1|Outcome|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at Week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827491|NCT01302041|E1|Reported Event|Enzalutamide|Participants received oral enzalutamide at 160 mg once daily for 24 weeks. Participants who had clinical benefit at week 25 could continue to receive enzalutamide until disease progression, objective or clinical, or occurrence of an unacceptable toxicity, at the discretion of the investigator.
827492|NCT01301963|B3|Baseline|Total|Total of all reporting groups
827493|NCT01301963|B2|Baseline|Arm II|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
827494|NCT01301963|B1|Baseline|Arm I|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
827495|NCT01301963|P2|Participant Flow|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
827497|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
827498|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
827499|NCT01301963|O2|Outcome|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
827500|NCT01301963|O1|Outcome|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
827501|NCT01301963|E2|Reported Event|Arm II: Experimental|"Patients receive G-CSF SC QD on days 1-4 and plerixafor SC QD on days 4-8.~plerixafor: Given SC~filgrastim: Given SC"
827502|NCT01301963|E1|Reported Event|Arm I: Control|"Patients receive G-CSF SC QD on days 1-4.~filgrastim: Given SC"
827503|NCT01301950|B3|Baseline|Total|Total of all reporting groups
827504|NCT01301950|B2|Baseline|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827505|NCT01301950|B1|Baseline|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch® Personalized Solutions Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
827506|NCT01301950|P2|Participant Flow|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
827507|NCT01301950|P1|Participant Flow|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827526|NCT01301833|P3|Participant Flow|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827527|NCT01301833|P2|Participant Flow|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827922|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
827508|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
827509|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827510|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
827511|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827512|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
827513|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827514|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
827515|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827551|NCT01301833|E2|Reported Event|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827552|NCT01301833|E1|Reported Event|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827516|NCT01301950|O2|Outcome|TruMatch® Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (P.F.C. Sigma System) implanted using TruMatch® Personalized Solutions. Instrument: TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch® is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patients' distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
827517|NCT01301950|O1|Outcome|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827518|NCT01301950|E2|Reported Event|Conventional Total Knee Replacement|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments
827519|NCT01301950|E1|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions Instrument: TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
827520|NCT01301833|B5|Baseline|Total|Total of all reporting groups
827521|NCT01301833|B4|Baseline|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827522|NCT01301833|B3|Baseline|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827523|NCT01301833|B2|Baseline|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827524|NCT01301833|B1|Baseline|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827525|NCT01301833|P4|Participant Flow|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827528|NCT01301833|P1|Participant Flow|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827529|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827530|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827531|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827532|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827533|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827534|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827535|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827536|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827537|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827538|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827539|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827540|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827541|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827542|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827543|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827544|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827545|NCT01301833|O4|Outcome|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827546|NCT01301833|O3|Outcome|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827547|NCT01301833|O2|Outcome|Teneligliptin and Glinide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus glinide
827548|NCT01301833|O1|Outcome|Teneligliptin|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained )
827549|NCT01301833|E4|Reported Event|Teneligliptin and Alpha-glucosidase Inhibitor|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus alpha-glucosidase inhibitor
827550|NCT01301833|E3|Reported Event|Teneligliptin and Biguanide|teneligliptin (20 mg once daily, titrated to 40 mg if no adequate efficacy is obtained ) plus biguanide
827553|NCT01301742|B1|Baseline|Entire Study Population|"The two treatments given in a randomised order were:~Empagliflozin 25mg (Empa) was given as a single dose on Day 1~Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empa was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.~Between treatments there was a washout period of at least 7 days."
827554|NCT01301742|P2|Participant Flow|Empa and Gemfibrozil First, Then Empa|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions. This was followed by a washout period of at least 7 days, followed by Empa given as a single dose on Day 1.
827555|NCT01301742|P1|Participant Flow|Empa First, Then Empa and Gemfibrozil|Empagliflozin 25mg (Empa) was given as a single dose on Day 1, followed by a washout period of at least 7 days, followed by Gemfibrozil 600mg given twice daily for 5 days starting on day -2 and empa given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
827556|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
827557|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
827558|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
827559|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
827560|NCT01301742|O2|Outcome|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
827561|NCT01301742|O1|Outcome|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
827562|NCT01301742|E3|Reported Event|Gemfibrozil Alone|Between the first gemfibrozil administration and the empagliflozin administration, for the Empa and gemfibrozil treatment period.
827563|NCT01301742|E2|Reported Event|Empa and Gemfibrozil|Gemfibrozil 600mg was given twice daily for 5 days starting on day -2 and empagliflozin 25mg (empa) was given as a single dose on Day 1, with gemfibrozil under steady-state conditions.
827564|NCT01301742|E1|Reported Event|Empa Alone|Empagliflozin (Empa) 25mg given as a single dose on Day 1.
827565|NCT01301729|B1|Baseline|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827923|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827566|NCT01301729|P1|Participant Flow|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827567|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827568|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827569|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827570|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827571|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827572|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827573|NCT01301729|O1|Outcome|Tastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827574|NCT01301729|O1|Outcome|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
828123|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
827575|NCT01301729|E1|Reported Event|Trastuzumab|Participants with metastatic breast cancer received a loading dose of 4 milligrams per kilograms (mg/kg) of trastuzumab intravenously (IV) followed by 2 mg/kg of trastuzumab IV once a week along with docetaxel 100 milligrams per meter square (mg/m^2), every 3 weeks or paclitaxel 90 mg/m^2 once a week until progression of disease, occurrence of intolerable toxicity, the participant discontinues the study or dies.
827576|NCT01301508|B3|Baseline|Total|Total of all reporting groups
827577|NCT01301508|B2|Baseline|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827578|NCT01301508|B1|Baseline|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827579|NCT01301508|P2|Participant Flow|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827580|NCT01301508|P1|Participant Flow|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate atopic dermatitis (AD) applied AN2898 ointment, 1 percent (%) to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827581|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827582|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827583|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827584|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827585|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827586|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827587|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827588|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827589|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827590|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827591|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827592|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827593|NCT01301508|O2|Outcome|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827810|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
828445|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
827594|NCT01301508|O1|Outcome|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827595|NCT01301508|E2|Reported Event|AN2728 Ointment, 2% + Ointment Vehicle|Participants with mild to moderate AD applied AN2728 ointment, 2% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2728 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827596|NCT01301508|E1|Reported Event|AN2898 Ointment, 1% + Ointment Vehicle|Participants with mild to moderate AD applied AN2898 ointment, 1% to one target lesion (active lesion), topically twice daily from Day 1 to 42 and AN2898 ointment vehicle applied twice daily from Day 1 to 42 to a second target lesion (vehicle lesion). Target lesions were identified at Baseline (Day 1) by investigator.
827597|NCT01301274|B3|Baseline|Total|Total of all reporting groups
827598|NCT01301274|B2|Baseline|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
827599|NCT01301274|B1|Baseline|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
827600|NCT01301274|P2|Participant Flow|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
827601|NCT01301274|P1|Participant Flow|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
827602|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
827603|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
827604|NCT01301274|O2|Outcome|Isotonic Arm|patients who received for maintenance solution ClNa 0.9% in Dx 5%
827605|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received fro maintenance solution ClNa 0.45% in Dx 5%
827606|NCT01301274|O2|Outcome|Isotonic Arm|patients who received maintenance solution 0.9% ClNa in Dx 5%
827607|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received maintenance solution 0.45% ClNa in Dx 5%
827608|NCT01301274|O2|Outcome|Isotonic Arm|Patients who received for maintenance solution 0.9% ClNa in Dx 5%
827609|NCT01301274|O1|Outcome|Hypotonic Arm|patients who received for maintenance solution 0.45% ClNa in Dx 5%
827610|NCT01301274|E2|Reported Event|Isotonic|Subjects in this arm will receive 0.9% NaCl/5% dextrose intravenous maintenance fluids.
827611|NCT01301274|E1|Reported Event|Hypotonic|Subjects in this arm will receive 0.45% NaCl/5% dextrose intravenous maintenance fluids.
827612|NCT01301092|B4|Baseline|Total|Total of all reporting groups
827613|NCT01301092|B3|Baseline|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
827614|NCT01301092|B2|Baseline|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods
827615|NCT01301092|B1|Baseline|Part A: LY2189265 Intravenous|Single 0.1 milligram (mg) intravenous (IV) dose of LY2189265
827616|NCT01301092|P3|Participant Flow|Part C: LY2189265 Subcutaneous, Intramuscular|Participants were randomized to 2 sequences of 2 treatments. Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.75-mg intramuscular (IM) of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
827617|NCT01301092|P2|Participant Flow|Part B: LY2189265 Subcutaneous, Intravenous|Participants were randomized to 2 sequences of 2 treatments. Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1; single 0.1-mg intravenous (IV) dose of LY2189265 in Period 2 or vice versa. There was a washout period of at least 4 weeks between dosing periods.
827618|NCT01301092|P1|Participant Flow|Part A: LY2189265 Intravenous|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265.
827619|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
827620|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1 or 2
827621|NCT01301092|O2|Outcome|Part C: LY2189265 Subcutaneous|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2
827622|NCT01301092|O1|Outcome|Part C: LY2189265 Intramuscular|Single 0.75-milligram (mg) intramuscular (IM) of LY2189265 in Period 1or 2
827623|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
827624|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5-milligram (mg) subcutaneous (SC) dose of LY2189265 in Period 1 or 2
827625|NCT01301092|O2|Outcome|Part B: LY2189265 Intravenous|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2
827626|NCT01301092|O1|Outcome|Part B: LY2189265 Subcutaneous|Single 1.5 mg-subcutaneous (SC) dose of LY2189265 in Period 1 or 2
827627|NCT01301092|E5|Reported Event|Part C: 0.75 mg SC LY2189265|Single 0.75-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
827628|NCT01301092|E4|Reported Event|Part C: 0.75 mg IM LY2189265|Single 0.75-mg intramuscular (IM) of LY2189265 in Period 1 or 2.
827629|NCT01301092|E3|Reported Event|Part B: 1.5 mg SC LY2189265|Single 1.5-mg subcutaneous (SC) dose of LY2189265 in Period 1 or 2.
827630|NCT01301092|E2|Reported Event|Part B: 0.1 mg IV LY2189265|Single 0.1-mg intravenous (IV) dose of LY2189265 in Period 1 or 2.
827631|NCT01301092|E1|Reported Event|Part A: 0.1 mg IV LY2189265|Single 0.1-milligram (mg) intravenous (IV) dose of LY2189265
827632|NCT01301079|B3|Baseline|Total|Total of all reporting groups
827749|NCT01300819|B1|Baseline|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827633|NCT01301079|B2|Baseline|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. Patients in group 2 (G2) received remifentanil (0.4 μg/kg/min) and saline solution.~Saline : Patients in group N (placebo)will receive saline during surgery."
827634|NCT01301079|B1|Baseline|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure. The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Ketamine : Patients in group ketamine will receive ketamine (5mcg/kg/min) during the surgery."
827635|NCT01301079|P2|Participant Flow|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827636|NCT01301079|P1|Participant Flow|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827637|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827638|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827639|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827640|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827641|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827642|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827643|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827811|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
828124|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
827644|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827645|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827646|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827647|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827648|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827924|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
827649|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827650|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827651|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827652|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827653|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827654|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827812|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827813|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827655|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827656|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827657|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827658|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827670|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827659|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827660|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827661|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827662|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827663|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827664|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827665|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827814|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827666|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827667|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827668|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827669|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827671|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827672|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827673|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827674|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827675|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827676|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827815|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827677|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827678|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827679|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827680|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827718|NCT01301066|E2|Reported Event|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
827719|NCT01301066|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
827720|NCT01301027|B3|Baseline|Total|Total of all reporting groups
827721|NCT01301027|B2|Baseline|Placebo|Placebo: 1 pill a day for 26 weeks
827722|NCT01301027|B1|Baseline|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
827681|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827682|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827683|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827684|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827685|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827686|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827687|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827688|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827689|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827690|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827691|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827692|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group 1 (G1) received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827693|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827694|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827695|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827696|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Neostigmine was used for antagonizing the neuromuscular block."
827697|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827698|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
828125|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
827699|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827700|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827701|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution.~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Saline: Patients in group N (placebo) was administrated saline during surgery."
827723|NCT01301027|P2|Participant Flow|Placebo|Placebo: 1 pill a day for 26 weeks
827724|NCT01301027|P1|Participant Flow|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
827725|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
827726|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
827727|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
827702|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min).~Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block.~Ketamine: Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery."
827703|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827704|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827705|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827706|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827707|NCT01301079|O2|Outcome|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827708|NCT01301079|O1|Outcome|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and ketamine (5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827750|NCT01300819|P2|Participant Flow|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827709|NCT01301079|E2|Reported Event|Saline|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group saline received remifentanil (0.4 μg/kg/min) and saline solution. Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827710|NCT01301079|E1|Reported Event|Ketamine|"A cardioscope, a capnograph, a pulse oximeter, and a noninvasive blood pressure meter were used to monitor the patients. Propofol (2-4 mg/kg), 1 μg/kg remifentanil, and atracurium (0.5 mg/kg) were administered for intubation. Atracurium was titrated to maintain muscle relaxation. Anesthesia was maintained with remifentanil, 0.8% isoflurane, and 50% oxygen without nitrous oxide. Infusion of the solutions was continued until skin closure.~The patients in group ketamine received remifentanil (0.4 μg/kg/min) and (ketamine 5 μg/kg/min). Remifentanil was administered as necessary until skin closure. Neostigmine was used for antagonizing the neuromuscular block."
827711|NCT01301066|B3|Baseline|Total|Total of all reporting groups
827712|NCT01301066|B2|Baseline|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
827713|NCT01301066|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
827714|NCT01301066|P2|Participant Flow|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
827715|NCT01301066|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
827716|NCT01301066|O2|Outcome|Pravastatin 40 mg QD|Pravastatin: Pravastatin 40 mg QD
827717|NCT01301066|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin: Pitavastatin 4 mg QD
827728|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
827729|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
827730|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
827731|NCT01301027|O2|Outcome|Placebo|Placebo: 1 pill a day for 26 weeks
827732|NCT01301027|O1|Outcome|Pioglitazone|Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
827733|NCT01301027|E2|Reported Event|Placebo|"1 placebo pill a day matching the pioglitazone treatment for 26 weeks~Placebo: 1 pill a day for 26 weeks"
827734|NCT01301027|E1|Reported Event|Pioglitazone|"15 mg/day pioglitazone for 2 weeks, then 30 mg/day for remaining 24 weeks~Pioglitazone: 15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks"
827735|NCT01300923|B1|Baseline|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
827736|NCT01300923|P2|Participant Flow|Autism Spectrum Disorder (ADS)|This baseline comparison group will participated in only and biomarker portion of subject characterization.
827737|NCT01300923|P1|Participant Flow|Acamprosate|"The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.~Acamprosate"
827738|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
827739|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
827740|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day).
827741|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
827742|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
827743|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
827744|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day)
827745|NCT01300923|O1|Outcome|Acamprosate Treatment Group|Twelve subjects received open-label acamprosate, mean final of 1,054 mg/day (range: 666-1,998 mg/day).
827746|NCT01300923|E1|Reported Event|Acamprosate|The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 60kg and 1332 mg per day for those less weighing less than 60kg.
827747|NCT01300819|B3|Baseline|Total|Total of all reporting groups
827748|NCT01300819|B2|Baseline|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827809|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827751|NCT01300819|P1|Participant Flow|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827752|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827753|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827754|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827755|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827788|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827789|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827925|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827756|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827757|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827758|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827759|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827760|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827761|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827762|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827763|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
828126|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
827764|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827765|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827766|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827767|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827768|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827769|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827770|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827771|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827772|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827773|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827774|NCT01300819|O2|Outcome|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827775|NCT01300819|O1|Outcome|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827776|NCT01300819|E2|Reported Event|Rotigotine|"Rotigotine : Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
828446|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
827777|NCT01300819|E1|Reported Event|Placebo|"Placebo : Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose will be up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose is reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.~Optimal or maximal dose will be maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
827778|NCT01300767|B1|Baseline|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
827779|NCT01300767|P1|Participant Flow|Lotrafilcon B /Balafilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with balafilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
827780|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827781|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827782|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827783|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827784|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827785|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827786|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827787|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827790|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827791|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827792|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827793|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827794|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827795|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827796|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827797|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827798|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827799|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827800|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827801|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827802|NCT01300767|O2|Outcome|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827803|NCT01300767|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827804|NCT01300767|E2|Reported Event|Balafilcon A|Balafilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827805|NCT01300767|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear DW) modality.
827806|NCT01300741|B1|Baseline|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
827807|NCT01300741|P1|Participant Flow|Lotrafilcon B / Galyfilcon A|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye, with galyfilcon A commercially marketed contact lens in the fellow eye for contralateral wear. Lenses were worn in a daily wear (DW) modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
827808|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
828447|NCT01299103|O1|Outcome|Single Treatment|Subjects receive one treatment
827816|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827817|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827818|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827819|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827820|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827821|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827822|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827823|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827824|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827825|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827826|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827827|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827828|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827829|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827830|NCT01300741|O2|Outcome|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827831|NCT01300741|O1|Outcome|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827832|NCT01300741|E2|Reported Event|Galyfilcon A|Galyfilcon A commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality, with a replacement lens issued at 2 weeks.
827833|NCT01300741|E1|Reported Event|Lotrafilcon B|Lotrafilcon B commercially marketed contact lens randomly assigned to one eye and worn for up to 4 weeks in a daily wear (DW) modality.
827834|NCT01300728|B3|Baseline|Total|Total of all reporting groups
827835|NCT01300728|B2|Baseline|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827836|NCT01300728|B1|Baseline|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827837|NCT01300728|P2|Participant Flow|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827838|NCT01300728|P1|Participant Flow|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827839|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827840|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827841|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827842|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827843|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827950|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
827844|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827845|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827846|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827847|NCT01300728|O2|Outcome|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827848|NCT01300728|O1|Outcome|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827849|NCT01300728|E2|Reported Event|Saline Solution|"0.9% saline solution~Placebo: Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio."
827850|NCT01300728|E1|Reported Event|Intravenous Immunoglobulin (IVIG)|"IVIG (NewGam 10%)at 0.4 g/kg~NewGam 10% IVIG: Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
827851|NCT01300650|B1|Baseline|Anakinra|
827852|NCT01300650|P1|Participant Flow|Anakinra|Anakinra 100 mg subcutaneous daily injection
827853|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous injection
827854|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
827855|NCT01300650|O1|Outcome|Anakinra|Anakinra 100 mg subcutaneous daily injection
827856|NCT01300650|E1|Reported Event|Anakinra|
827857|NCT01300624|B1|Baseline|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827858|NCT01300624|P1|Participant Flow|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827859|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Verb Network Strengthening Treatment (VNeST) tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced.~Verb Network Strengthening Treatment: Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke."
827860|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827861|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827862|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
828127|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
827863|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827864|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827865|NCT01300624|O1|Outcome|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827866|NCT01300624|E1|Reported Event|Verb Network Strengthening Treatment|"Treatment tasks involve the retrieval of nouns related to a target verb. For example, for the verb measure, participants would come up with people who measure and what they measure (e.g., carpenter/lumber, chef/sugar). They would then answer questions related to why, where, and when these things might occur (e.g., for carpenter/measure, they might say to get the right length of board, (why) at a construction site, (where) and when building a house (where). Cues and assistance are provided to the participants when they are unable to complete any given task. As the participants improve, cues are reduced."
827867|NCT01300559|B3|Baseline|Total|Total of all reporting groups
827868|NCT01300559|B2|Baseline|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
827869|NCT01300559|B1|Baseline|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
827870|NCT01300559|P2|Participant Flow|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
827871|NCT01300559|P1|Participant Flow|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
827872|NCT01300559|O2|Outcome|No Treatment Group|Unipolar electrocautery without Tissuelink device will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
827873|NCT01300559|O1|Outcome|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study. Hemoglobin loss for the participants in this group will be measured in g/dl.
827874|NCT01300559|E2|Reported Event|No Treatment|Unipolar electrocautery without Tissuelink device will be used in this arm of the study.
827875|NCT01300559|E1|Reported Event|Treatment Group|Tissuelink device plus Unipolar electrocautery will be used in this arm of the study.
827876|NCT01300546|B3|Baseline|Total|Total of all reporting groups
827877|NCT01300546|B2|Baseline|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827878|NCT01300546|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827879|NCT01300546|P2|Participant Flow|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827880|NCT01300546|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827881|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827882|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827883|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827884|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827951|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
827885|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827886|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827887|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827888|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827889|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827890|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827891|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827892|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827919|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827920|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
827893|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827894|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827895|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827896|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827897|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827898|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827899|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827900|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827901|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827902|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827903|NCT01300546|O2|Outcome|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827904|NCT01300546|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827905|NCT01300546|E2|Reported Event|Naproxen Sodium|In Treatment Period, subjects randomized to Naproxen Sodium 500mg will be provided with 14 tablets of Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue of persistent or recurring headache.
827906|NCT01300546|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period, subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat migraine within 1 hour of onset on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue of persistent or recurring headache.
827907|NCT01300455|B3|Baseline|Total|Total of all reporting groups
827908|NCT01300455|B2|Baseline|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
827909|NCT01300455|B1|Baseline|Suvorexant (40 mg) Then Placebo|In Period 1, Suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
827910|NCT01300455|P2|Participant Flow|Placebo Then Suvorexant (40 mg)|Period 1 consists of placebo administered once daily for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. In Period 2, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening.
827911|NCT01300455|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|In Period 1, suvorexant (40 mg tablets) administered orally, once daily, for 4 consecutive days in the evening. Period 1 is followed by a washout period of a minimum of 5 days. Period 2 consists of placebo administered once daily for 4 consecutive days in the evening.
827912|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
827913|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827914|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
827915|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827916|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
827917|NCT01300455|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827918|NCT01300455|O2|Outcome|Placebo|Participants administered placebo.
827926|NCT01300455|E2|Reported Event|Placebo|Participants administered placebo.
827927|NCT01300455|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
827928|NCT01300351|B3|Baseline|Total|Total of all reporting groups
827929|NCT01300351|B2|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827930|NCT01300351|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827931|NCT01300351|P2|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827932|NCT01300351|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827933|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827934|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827935|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827936|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827937|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827938|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827939|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827940|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827941|NCT01300351|O2|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827942|NCT01300351|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827943|NCT01300351|E2|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg im every 28 (± 3) days
827944|NCT01300351|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg intramuscular (im) every 28 (± 3) days plus an additional 500 mg on Day 15 (± 3) of first month only
827945|NCT01300338|B3|Baseline|Total|Total of all reporting groups
827946|NCT01300338|B2|Baseline|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
827947|NCT01300338|B1|Baseline|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
827948|NCT01300338|P2|Participant Flow|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry."
827949|NCT01300338|P1|Participant Flow|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
827952|NCT01300338|O2|Outcome|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
827953|NCT01300338|O1|Outcome|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
827954|NCT01300338|E2|Reported Event|Blood Pressure Without Telemetry|"Blood pressure self monitor without telemetry~Home blood pressure monitor without telemetry: Self monitor of blood pressure without telemetry"
827955|NCT01300338|E1|Reported Event|Blood Pressure With Telemetry|"Blood pressure monitor with telemetry~blood pressure with telemetry: Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager"
827956|NCT01300286|B1|Baseline|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously
827957|NCT01300286|P1|Participant Flow|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
827958|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
827959|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
827960|NCT01300286|O1|Outcome|RiaSTAP|"One time dose of 70 mg/kg will be administered intravenously.~RiaSTAP: One time dose of 70 mg/kg will be administered intravenously."
827961|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
827962|NCT01300286|O1|Outcome|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
827963|NCT01300286|E1|Reported Event|RiaSTAP|RiaSTAP: One time dose of 70 mg/kg will be administered intravenously.
827964|NCT01300260|B3|Baseline|Total|Total of all reporting groups
827965|NCT01300260|B2|Baseline|Participants With Type 2 Diabetes Mellitus (T2DM)|Includes participants with T2DM randomized to receive 1.5 mg LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
827966|NCT01300260|B1|Baseline|Healthy Participants|Includes healthy participants randomized to receive 1.5 milligram (mg) LY2189265 (Dulaglutide) first or Placebo first on Day 1 of either treatment sequence.
827967|NCT01300260|P2|Participant Flow|Placebo First, Then LY2189265|"Includes healthy participants and participants with T2DM. Placebo: Single subcutaneous (SC) injection of Placebo on Day 1 of Period 1. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) SC injection on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
827968|NCT01300260|P1|Participant Flow|LY2189265 First, Then Placebo|"Includes healthy participants or participants with T2DM. LY2189265 (Dulaglutide): Single 1.5 milligram (mg) subcutaneous (SC) injection on Day 1 of Period 1. Placebo: Single SC injection of Placebo on Day 1 of Period 2.~On Day 3 of each period, participants received a 6-hour (hr) insulin infusion, followed by an intravenous (IV) dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes [min]). Three hr later, a 2nd IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hr glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hr glucose >10 mmol/L) was administered, followed by a 20% dextrose at the set infusion rate of 600 milliliter/hr [mL/hr] for 35 min. Fifteen min after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.~There was a washout period of ≥28 days between Periods 1 & 2."
827969|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
827970|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
827971|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
828059|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
827972|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered
827973|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
827974|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
827975|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
827998|NCT01300247|B2|Baseline|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
827976|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes). Three hours later, participants were administered a second IV dextrose bolus 25 g of 50% dextrose or a suitably adjusted dose according to glycemic status (20 g of 50% dextrose for participants with 3-hour glucose between 5.2 and 10 millimole/liter [mmol/L] or 15 g of 50% dextrose for participants with 3-hour glucose >10 mmol/L), followed immediately by a 20% dextrose at the set infusion rate of 600 milliliter/hour [mL/h] for 35 minutes. Fifteen minutes after the start of the 20% dextrose infusion, an IV 1-mg glucagon bolus was administered.
827977|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827978|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827979|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827980|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827981|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827982|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827983|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827984|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827985|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
828128|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
827986|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes)
827987|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827988|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827989|NCT01300260|O4|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827990|NCT01300260|O3|Outcome|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827991|NCT01300260|O2|Outcome|Healthy Participants: LY2189265|Healthy participant first received a single subcutaneous injection of 1.5 milligram (mg) LY2189265 on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827992|NCT01300260|O1|Outcome|Healthy Participants: Placebo|Healthy participants first received a single subcutaneous injection of Placebo on Day 1. On Day 3, participants received a 6-hour insulin infusion followed by a dextrose bolus (50% dextrose bolus, 0.3 gram/kilogram [g/kg] over approximately 2 minutes).
827993|NCT01300260|E4|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): LY2189265|T2DM participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
827994|NCT01300260|E3|Reported Event|Participants With Type 2 Diabetes Mellitus (T2DM): Placebo|T2DM participants who received at least 1 subcutaneous injection of Placebo
827995|NCT01300260|E2|Reported Event|Healthy Participants: LY2189265|Healthy participants who received at least 1 subcutaneous injection of 1.5 milligram (mg) LY2189265
827996|NCT01300260|E1|Reported Event|Healthy Participants: Placebo|Healthy participants who received at least 1 subcutaneous injection of Placebo
827997|NCT01300247|B3|Baseline|Total|Total of all reporting groups
828185|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
827999|NCT01300247|B1|Baseline|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828000|NCT01300247|P2|Participant Flow|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828001|NCT01300247|P1|Participant Flow|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 milligrams [mg] intravenous [IV] infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 milligrams per meter square [mg/m^2] IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828002|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828003|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828004|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828005|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828006|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828007|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828060|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828008|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828009|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828010|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828011|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828012|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828013|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828014|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828015|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828038|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828016|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828017|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828018|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828019|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828020|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828021|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828022|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828023|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828024|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828025|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828061|NCT01300234|E2|Reported Event|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828026|NCT01300247|O2|Outcome|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828027|NCT01300247|O1|Outcome|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828028|NCT01300247|E2|Reported Event|Obinutuzumab + Bendamustine|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6) and bendamustine (90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6).
828029|NCT01300247|E1|Reported Event|Obinutuzumab + Fludarabine + Cyclophosphamide|Participants received 6 cycles (each 28-day cycle) of obinutuzumab (1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6), fludarabine (25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6) and cyclophosphamide 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6). The Cycle 1 Day 1 dose of obinutuzumab was split over two days (Cycle 1 Day 1 and Cycle 1 Day 2).
828030|NCT01300234|B3|Baseline|Total|Total of all reporting groups
828031|NCT01300234|B2|Baseline|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828032|NCT01300234|B1|Baseline|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828033|NCT01300234|P2|Participant Flow|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828034|NCT01300234|P1|Participant Flow|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828035|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828036|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828037|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828039|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828040|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828041|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828042|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828043|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828044|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828045|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828046|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828047|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828048|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828049|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828050|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828051|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828052|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828053|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828054|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828055|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828056|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828057|NCT01300234|O2|Outcome|ADV 10 mg|Participants self-administered ADV 10 mg tablets plus matching TDF placebo at the same time once daily for 48 weeks.
828058|NCT01300234|O1|Outcome|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828062|NCT01300234|E1|Reported Event|TDF 300 mg|Participants self-administered tenofovir disoproxil fumarate (TDF) 300 milligram (mg) tablets plus matching adefovir dipivoxil (ADV) placebo at the same time once daily for 48 weeks.
828063|NCT01300052|B3|Baseline|Total|Total of all reporting groups
828064|NCT01300052|B2|Baseline|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828065|NCT01300052|B1|Baseline|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828066|NCT01300052|P2|Participant Flow|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828067|NCT01300052|P1|Participant Flow|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator
828068|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828069|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828070|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828071|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828072|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828073|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828074|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828075|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828832|NCT01298128|P1|Participant Flow|NuvaRing|NuvaRing for IVF pre-treatment
828076|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828077|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828078|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828079|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828080|NCT01300052|O2|Outcome|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828081|NCT01300052|O1|Outcome|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828082|NCT01300052|E2|Reported Event|AN2728 Ointment, Vehicle|AN2728 ointment vehicle was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828083|NCT01300052|E1|Reported Event|AN2728 Ointment, 2%|AN2728 ointment, 2% was applied topically twice daily to all psoriasis plaques within each participant for 12 weeks (84 days). Plaques were identified at Baseline (Day 1) by the investigator.
828084|NCT01299961|B1|Baseline|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
828085|NCT01299961|P1|Participant Flow|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
828086|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
828087|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
828088|NCT01299961|O1|Outcome|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
828089|NCT01299961|E1|Reported Event|Subcutaneous Abatacept|All subjects will receive an injection of 125 mg of abatacept once a week up to 12 months.
828090|NCT01299909|B4|Baseline|Total|Total of all reporting groups
828091|NCT01299909|B3|Baseline|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
828092|NCT01299909|B2|Baseline|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
828121|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828122|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828093|NCT01299909|B1|Baseline|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
828094|NCT01299909|P3|Participant Flow|Quitline|Non-Randomized, Treatment as Usual condition; participants self-selected to this group and received smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL).
828095|NCT01299909|P2|Participant Flow|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
828096|NCT01299909|P1|Participant Flow|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
828097|NCT01299909|O2|Outcome|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
828098|NCT01299909|O1|Outcome|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
828099|NCT01299909|E3|Reported Event|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
828100|NCT01299909|E2|Reported Event|Integrated Training for Smokers|"ITS participants will receive 8 classes of training in smoking cessation strategies, access to the Freedom From Smoking online program, and 2 weeks of nicotine patches.~Integrated Training for Smokers: 8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program"
828101|NCT01299909|E1|Reported Event|Mindfulness Training for Smokers|"MTS participants will receive 8 classes of training in mindfulness meditation, access to the MTS website, and 2 weeks of nicotine patches.~Mindfulness Training for Smokers: 8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website."
828102|NCT01299896|B3|Baseline|Total|Total of all reporting groups
828184|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828103|NCT01299896|B2|Baseline|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
828104|NCT01299896|B1|Baseline|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
828105|NCT01299896|P2|Participant Flow|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
828106|NCT01299896|P1|Participant Flow|Usual Care|"Participants will continue to receive all the care currently offered in the Veterans Administration Pittsburgh Healthcare System (VAPHS), including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
828107|NCT01299896|O2|Outcome|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
828108|NCT01299896|O1|Outcome|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
828109|NCT01299896|E2|Reported Event|Coordinated Care|"A CTQ Coordinator will coordinate the delivery of smoking related care.~Coordinated Care: CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly."
828110|NCT01299896|E1|Reported Event|Usual Care|"Participants will continue to receive all the care currently offered in the VAPHS, including medications for smoking cessation and use of the in-person or telephone counseling options for quit smoking classes. For veterans with a co-pay, incurred fees with be reimbursed.~Usual Care: Standard therapy to help participants with smoking cessation."
828111|NCT01299805|B3|Baseline|Total|Total of all reporting groups
828112|NCT01299805|B2|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828113|NCT01299805|B1|Baseline|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828114|NCT01299805|P2|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828115|NCT01299805|P1|Participant Flow|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828116|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828117|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828118|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828119|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828120|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828129|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828130|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828131|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828132|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828133|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828134|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828135|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828136|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828137|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828138|NCT01299805|O2|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828139|NCT01299805|O1|Outcome|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828140|NCT01299805|E2|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 14 days.
828141|NCT01299805|E1|Reported Event|Vortioxetine|Vortioxetine 20 mg, encapsulated tablet, orally, once daily for up to 14 days.
828142|NCT01299584|B1|Baseline|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
828143|NCT01299584|P1|Participant Flow|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
828144|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
828145|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
828833|NCT01298128|O2|Outcome|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
828146|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
828147|NCT01299584|O1|Outcome|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
828148|NCT01299584|E1|Reported Event|Ultiva 1, 2, or 3 mg|One vial of Ultiva 1, 2, or 3 milligrams (mg) contains remifentanil hydrochloride (in-house specification) 1.10 mg, 2.21 mg, or 5.53 mg, respectively (as remifentanil 1 mg, 2 mg, or 5 mg, respectively). Participants were administered doses according to physician decision.
828149|NCT01299571|B1|Baseline|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
828150|NCT01299571|P1|Participant Flow|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily.
828151|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
828152|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
828153|NCT01299571|O1|Outcome|Avodart 0.5 mg|Avodart capsule containing 0.5 mg of dutasteride was administered orally once daily
828154|NCT01299571|E1|Reported Event|Avodart 0.5 mg|Avodart capsule containing 0.5 milligrams (mg) of dutasteride was administered orally once daily
828155|NCT01299480|B6|Baseline|Total|Total of all reporting groups
828156|NCT01299480|B5|Baseline|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828157|NCT01299480|B4|Baseline|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828158|NCT01299480|B3|Baseline|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828159|NCT01299480|B2|Baseline|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828160|NCT01299480|B1|Baseline|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828161|NCT01299480|P5|Participant Flow|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828162|NCT01299480|P4|Participant Flow|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828163|NCT01299480|P3|Participant Flow|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828164|NCT01299480|P2|Participant Flow|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828165|NCT01299480|P1|Participant Flow|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828166|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828167|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828168|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828169|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828170|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828171|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828172|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828173|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828174|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828175|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828176|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828177|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828178|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828179|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828180|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828181|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828182|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828183|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828834|NCT01298128|O1|Outcome|NuvaRing|NuvaRing for IVF pre-treatment
828186|NCT01299480|O1|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828187|NCT01299480|O5|Outcome|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828188|NCT01299480|O4|Outcome|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828189|NCT01299480|O3|Outcome|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828190|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828191|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828192|NCT01299480|O2|Outcome|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828193|NCT01299480|O1|Outcome|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828194|NCT01299480|E5|Reported Event|Group 5: rLP2086(2-,6- Month)+ Saline(0-,1- Month)|Randomized to receive rLP2086 on a 2-, 6- month and 0.9% normal saline on a 0-, 1- month schedule.
828195|NCT01299480|E4|Reported Event|Group 4: rLP2086(0-,2- Month)+Saline(1-,6- Month)|Randomized to receive rLP2086 on a 0-, 2- month and 0.9% normal saline on a 1-, 6- month schedule.
828196|NCT01299480|E3|Reported Event|Group 3: rLP2086(0-,6- Month)+Saline(1-,2- Month)|Randomized to receive rLP2086 on a 0-, 6- month and 0.9% normal saline on a 1-, 2- month schedule.
828197|NCT01299480|E2|Reported Event|Group 2:rLP2086(0-,2-,6- Month)+Saline(1- Month)|Randomized to receive rLP2086 on a 0-, 2-, 6- month and 0.9% normal saline on a 1- month schedule.
828198|NCT01299480|E1|Reported Event|Group 1:rLP2086(0-,1-,6- Month)+Saline(2- Month)|Randomized to receive rLP2086 on a 0-, 1-, 6- month and 0.9% normal saline on a 2- month schedule.
828199|NCT01299454|B5|Baseline|Total|Total of all reporting groups
828200|NCT01299454|B4|Baseline|Normal Hepatic Function|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828201|NCT01299454|B3|Baseline|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828202|NCT01299454|B2|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828203|NCT01299454|B1|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828204|NCT01299454|P4|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
828205|NCT01299454|P3|Participant Flow|Severe Hepatic Impairment|Participants with severe hepatic impairment (based on Child-Pugh classification scheme) received a single dose of oral brexpiprazole 2 mg.
828206|NCT01299454|P2|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme)received a single dose of oral brexpiprazole 2 mg.
828207|NCT01299454|P1|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 milligrams (mg).
828208|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828209|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828210|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828211|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828212|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828213|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828214|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828215|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828216|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828217|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828218|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828219|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828220|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828221|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828222|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828223|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
829123|NCT01297062|O1|Outcome|Exenatide|Exenatide
828224|NCT01299454|O4|Outcome|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828225|NCT01299454|O3|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828226|NCT01299454|O2|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828227|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828228|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828229|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828230|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828231|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828232|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828233|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828234|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828235|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828236|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828441|NCT01299103|P1|Participant Flow|Single Treatment|Subjects receive one treatment
828237|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
828238|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828239|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828240|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828241|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828242|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
828243|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828244|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828245|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828246|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828247|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828248|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828249|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828250|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828251|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828252|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828253|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828254|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828255|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828256|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828257|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828258|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828259|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828260|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
828261|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828262|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828263|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828264|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828265|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828266|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828267|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828268|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828269|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828270|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828271|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828272|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828273|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828274|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828275|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828276|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828277|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828278|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828279|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828280|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828281|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828282|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828283|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828284|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828285|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828286|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828287|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828288|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828289|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828290|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828291|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828292|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828293|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828294|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
828295|NCT01299454|O5|Outcome|Sever Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828296|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828297|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828298|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828299|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828300|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
828301|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828302|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
828303|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828304|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828305|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828306|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828307|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828308|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828309|NCT01299454|O3|Outcome|Moderate Hepatic Function|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828310|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828311|NCT01299454|O1|Outcome|Mild Hepatic Function|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828312|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828313|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828314|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828315|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828316|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participants with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Partipants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828317|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828318|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828319|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828320|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828321|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828322|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828323|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828324|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828325|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828326|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828327|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828328|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828329|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828330|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant ith hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828331|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828332|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828333|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828384|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularl (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
828414|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
828334|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participant with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828335|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828336|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a particpant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828337|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with normal hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828338|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828339|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828340|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828341|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828342|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
828343|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828344|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828345|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828346|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each subject with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Subjects with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828347|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828348|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled"
828349|NCT01299454|O5|Outcome|Severe Hepatic Function|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828350|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828351|NCT01299454|O3|Outcome|Moderate Hepatic Impairment.|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828352|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828353|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg
828354|NCT01299454|O6|Outcome|Normal Hepatic Function Matched to Severe Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828355|NCT01299454|O5|Outcome|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828356|NCT01299454|O4|Outcome|Normal Hepatic Function Matched to Moderate Hepatic Function.|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a subject with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828357|NCT01299454|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828358|NCT01299454|O2|Outcome|Normal Hepatic Function Matched to Mild Hepatic Function|"Participants with normal hepatic function received a single oral dose of brexpiprazole 2 mg.~Each participant with normal hepatic function was matched to a participant with hepatic impairment by age (within the decile or ± 5 years, whichever was less), sex, and weight (± 15%). Participants with hepatic impairment and within 30% of their ideal body weight (minimum body weight of 50 kg) were enrolled."
828359|NCT01299454|O1|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828360|NCT01299454|E4|Reported Event|Normal Hepatic Function|Participants with normal hepatic function (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828361|NCT01299454|E3|Reported Event|Severe Hepatic Impairment|Participants with severe hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828362|NCT01299454|E2|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828363|NCT01299454|E1|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment (Child-Pugh classification scheme) received a single oral dose of brexpiprazole 2 mg.
828364|NCT01299389|B3|Baseline|Total|Total of all reporting groups
828365|NCT01299389|B2|Baseline|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
828366|NCT01299389|B1|Baseline|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
828367|NCT01299389|P4|Participant Flow|Paliperidone Palmitate (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
828368|NCT01299389|P3|Participant Flow|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
828369|NCT01299389|P2|Participant Flow|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828370|NCT01299389|P1|Participant Flow|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
828371|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828372|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
828373|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828374|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
828375|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828376|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
828377|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828378|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
828379|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828380|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
828381|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828382|NCT01299389|O1|Outcome|Placebo (Double-blind)|Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
828383|NCT01299389|O2|Outcome|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828519|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828385|NCT01299389|E4|Reported Event|Paliperidone Palmitate (Post-0bservational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
828386|NCT01299389|E3|Reported Event|Placebo (Post-observational)|Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
828387|NCT01299389|E2|Reported Event|Paliperidone Palmitate (Double-blind)|Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
828388|NCT01299389|E1|Reported Event|Placebo (Double-blind)|Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
828389|NCT01299376|B3|Baseline|Total|Total of all reporting groups
828390|NCT01299376|B2|Baseline|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828391|NCT01299376|B1|Baseline|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828392|NCT01299376|P2|Participant Flow|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828393|NCT01299376|P1|Participant Flow|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828394|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
828395|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
828396|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828397|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828398|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828399|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828400|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828442|NCT01299103|O3|Outcome|Triple Treatment|Subjects receive three treatments
828443|NCT01299103|O2|Outcome|Double Treatment|Subjects receive two treatments
828401|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828402|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828403|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828404|NCT01299376|O2|Outcome|L50/H12.5→L50/H12.5/A5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period. Participants then receive once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828405|NCT01299376|O1|Outcome|L50/H12.5/A5→L50/H12.5/A5|One combination tablet containing L50 mg, H12.5 mg, and A5 mg, orally, once daily, for up to 8 weeks (double-blind treatment period). Participants continue with once daily L50/H12.5/A5 for 44 weeks during open-label extension.
828406|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
828407|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
828408|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
828409|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
828410|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
828411|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
828412|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
828413|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
828415|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
828416|NCT01299376|O2|Outcome|L50/H12.5|One combination tablet containing L50 mg and H12.5 mg, orally, once daily, for up to 8 weeks during double-blind treatment period.
828417|NCT01299376|O1|Outcome|L50/H12.5/A5|One combination tablet containing L50 mg H12.5 mg and A5, orally, once daily, for up to 8 weeks during double-blind treatment period.
828418|NCT01299376|E4|Reported Event|L50/H12.5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5 combination tablet in double-blind treatment period and then received L50/H12.5/A5 orally once daily for 44 weeks in extension period.
828419|NCT01299376|E3|Reported Event|L50/H12.5/A5→L50/H12.5/A5 - Extension|Participants who received L50/H12.5/A5 combination tablet in double-blind treatment period and continued to receive L50/H12.5/A5 orally once daily for 44 weeks in extension period.
828420|NCT01299376|E2|Reported Event|L50/H12.5/A5 - Double Blind Treatment Period|Participants received L50/H12.5/A5 combination tablet, orally once daily for 8 weeks
828421|NCT01299376|E1|Reported Event|L50/H12.5- Double Blind Treatment Period|Participants received L50/H12.5 combination tablet, orally once daily for 8 weeks
828422|NCT01299285|B1|Baseline|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828423|NCT01299285|P1|Participant Flow|LY3009104 (Baricitinib)|Single 10-milligram (mg) oral dose containing 100 microcuries of 14C-labeled LY3009104
828424|NCT01299285|O2|Outcome|LY3009104 Metabolites|The percentage of total radioactivity of all LY3009104 metabolites in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828425|NCT01299285|O1|Outcome|LY3009104|The percentage of total radioactivity of LY3009104 (parent) in the plasma after receiving a single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828426|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828427|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828428|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828429|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828430|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828431|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828432|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828433|NCT01299285|O1|Outcome|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828434|NCT01299285|E1|Reported Event|LY3009104|Single 10-mg oral dose containing 100 microcuries of 14C-labeled LY3009104
828435|NCT01299103|B4|Baseline|Total|Total of all reporting groups
828436|NCT01299103|B3|Baseline|Triple Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
828437|NCT01299103|B2|Baseline|Double Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
828438|NCT01299103|B1|Baseline|Single Treatment|Pelleve Wrinkle Treatment System: comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
828439|NCT01299103|P3|Participant Flow|Triple Treatment|Subjects receive three treatments
828440|NCT01299103|P2|Participant Flow|Double Treatment|Subjects receive two treatments
828448|NCT01299103|E3|Reported Event|Triple Treatment|Subjects receive three treatments
828449|NCT01299103|E2|Reported Event|Double Treatment|Subjects receive two treatments
828450|NCT01299103|E1|Reported Event|Single Treatment|Subjects receive one treatment
828451|NCT01299090|B1|Baseline|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
828452|NCT01299090|P1|Participant Flow|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
828453|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
828454|NCT01299090|O1|Outcome|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
828455|NCT01299090|E1|Reported Event|Treatment Group|"All subjects enrolled were in the treatment group.~Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator: two treatments spaced 30 days apart"
828456|NCT01299077|B1|Baseline|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828457|NCT01299077|P1|Participant Flow|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828458|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828459|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828520|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828521|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828460|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828461|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828462|NCT01299077|O1|Outcome|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828463|NCT01299077|E1|Reported Event|Lumbar Disc Degenerative Disease|"Triple therapy ( Methycobal (MBL) + Myonal (MYO) + non-steroidal anti-inflammatory drugs (NSAIDs)) which prescribed by doctors (Drs) based on disease condition. MBL 0.5 mg : three times daily for two weeks, MYO 50 mg : three times daily for two weeks:~NSAID (diclofenac) 75 mg,: twice daily for two weeks"
828464|NCT01299025|B3|Baseline|Total|Total of all reporting groups
828465|NCT01299025|B2|Baseline|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
828466|NCT01299025|B1|Baseline|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
828467|NCT01299025|P2|Participant Flow|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
828468|NCT01299025|P1|Participant Flow|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
828469|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
828470|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
828471|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
828472|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
828473|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
828474|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
828475|NCT01299025|O2|Outcome|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
828476|NCT01299025|O1|Outcome|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
828477|NCT01299025|E2|Reported Event|Training With Nintendo Wii Fit|"Training 6 weeks with Nintendo Wii Fit, 30 minutes 2 times per week~Training using Nintendo Wii Fit: Training 2 times per week, 30 minutes, for 6 weeks."
828478|NCT01299025|E1|Reported Event|Control|Participants allocated as controls receive no treatment. They may be physically active as usual.
828479|NCT01298778|B3|Baseline|Total|Total of all reporting groups
828554|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828602|NCT01298544|E1|Reported Event|Entire Study Population|All randomized participants
828480|NCT01298778|B2|Baseline|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828481|NCT01298778|B1|Baseline|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828482|NCT01298778|P2|Participant Flow|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828483|NCT01298778|P1|Participant Flow|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828484|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828485|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828486|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828487|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828488|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828489|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828490|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses~Duramorph 300: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828491|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph 150: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828492|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828493|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828494|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828495|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828496|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828497|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828498|NCT01298778|O2|Outcome|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828499|NCT01298778|O1|Outcome|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828500|NCT01298778|E2|Reported Event|Acetaminophen and Increased Dose of Duramorph|"Spinal consists of duramorph 300 mcg combined with fentanyl and bupivacaine in conjunction with Acetaminophen 1 Gm PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Acetaminophen: Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses"
828501|NCT01298778|E1|Reported Event|Standard of Care|"Spinal consists of duramorph 150 mcg combined with fentanyl and bupivacaine in conjunction with placebo capsules 2 PO q 6 hrs x 4 doses in first 24 hrs postop. Ibuprofen given as standard of care.~Duramorph: Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses"
828502|NCT01298661|B4|Baseline|Total|Total of all reporting groups
828503|NCT01298661|B3|Baseline|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828504|NCT01298661|B2|Baseline|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828505|NCT01298661|B1|Baseline|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828506|NCT01298661|P3|Participant Flow|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828507|NCT01298661|P2|Participant Flow|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828508|NCT01298661|P1|Participant Flow|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828509|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828510|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828511|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828512|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828513|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828514|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828515|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828516|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828517|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828518|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828830|NCT01298128|B1|Baseline|NuvaRing|NuvaRing for IVF pre-treatment
828522|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828523|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828524|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828525|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828526|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828527|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828528|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828529|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828530|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828531|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828532|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828533|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828534|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828535|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828536|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828537|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828538|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828539|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828540|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828541|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828542|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828543|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828544|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828545|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828546|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828547|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828548|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828549|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828550|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828551|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828552|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828553|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828603|NCT01298531|B3|Baseline|Total|Total of all reporting groups
828555|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828556|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828557|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828558|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828559|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828560|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828561|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828562|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828563|NCT01298661|O1|Outcome|COPD Patients|Patients with clinical and spirometrical diagnosis of Chronic Obstructive Pulmonary Disease
828564|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828565|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828566|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828567|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828568|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828569|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828570|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828571|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828572|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828573|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828574|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828575|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828576|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828577|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828578|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828579|NCT01298661|O3|Outcome|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828580|NCT01298661|O2|Outcome|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828581|NCT01298661|O1|Outcome|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828582|NCT01298661|E3|Reported Event|COPD Patients|Patients with clinical and spirometric diagnosis of COPD
828583|NCT01298661|E2|Reported Event|Healthy Elderly Subjects|Subjects apparently healthy, with age of 60 to 75 years old.
828584|NCT01298661|E1|Reported Event|Healthy Young Subjects|Subjects apparently healthy, with age of 18 to 27 years old.
828585|NCT01298648|B1|Baseline|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828586|NCT01298648|P1|Participant Flow|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828587|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828588|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828589|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828590|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828591|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828592|NCT01298648|O1|Outcome|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828593|NCT01298648|E1|Reported Event|Humira|Participants who were prescribed Humira per approved prescribing information of Humira in Japan.
828594|NCT01298544|B1|Baseline|Entire Study Population|All randomized participants
828595|NCT01298544|P1|Participant Flow|Entire Study Population|All randomized participants
828596|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
828597|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
828598|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
828599|NCT01298544|O3|Outcome|DTaP Alone|No investigational product was administered during the study. Participants previously received DTaP in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), and 5 months (vaccination 3).
828600|NCT01298544|O2|Outcome|7vPnC and DTaP|No investigational product was administered during the study. Participants previously received 7vPnC concomitantly with diphtheria, tetanus, and acellular pertussis vaccine (DTaP) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
828601|NCT01298544|O1|Outcome|7vPnC|No investigational product was administered during the study. Participants previously received 7-valent pneumococcal conjugate vaccine (7vPnC) in a preceding study, 0887X-101518, at 3 months (vaccination 1), 4 months (vaccination 2), 5 months (vaccination 3), and 12 to 15 months (vaccination 4) of age.
828604|NCT01298531|B2|Baseline|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828605|NCT01298531|B1|Baseline|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828606|NCT01298531|P2|Participant Flow|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828607|NCT01298531|P1|Participant Flow|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828608|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828609|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828610|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828611|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828612|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828613|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828614|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828615|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828616|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828617|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828618|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828619|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828620|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828621|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828622|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828623|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828624|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828625|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828626|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828627|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828628|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828629|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828630|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828631|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828632|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828633|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828634|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828635|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828636|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828637|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828638|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828780|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828639|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828640|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828641|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828642|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828643|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828644|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828645|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828646|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828647|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828648|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828649|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828650|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828651|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828652|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828653|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828654|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828655|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828656|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828657|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828658|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828659|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828660|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828661|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828662|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828663|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828664|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828665|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828666|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828667|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828668|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828669|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828670|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828671|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828672|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828673|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828896|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828674|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828675|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828676|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828677|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828678|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828679|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828680|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828681|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828682|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828683|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828684|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828685|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828686|NCT01298531|O1|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828687|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828831|NCT01298128|P2|Participant Flow|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
828688|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828689|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828690|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828691|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828692|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828693|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828694|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828695|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828696|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828697|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828698|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828699|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828700|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828701|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828702|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828703|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828704|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828705|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828706|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828707|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828708|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
829218|NCT01296698|E2|Reported Event|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
828709|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828710|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828711|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828712|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828713|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828714|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828715|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828716|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828717|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828718|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828719|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828720|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828721|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828722|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828723|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828724|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828725|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828726|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828727|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828728|NCT01298531|O2|Outcome|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828729|NCT01298531|O1|Outcome|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828730|NCT01298531|E2|Reported Event|Placebo to Open Label ETN 50 mg Group|Participants were treated with Placebo subcutaneous injections once weekly for 8 weeks followed by ETN 50 mg SC injections once weekly for 8 weeks
828731|NCT01298531|E1|Reported Event|Double Blind ETN 50 mg to Open Label ETN 50 mg Group|Participants were treated with ETN 50 mg subcutaneous injections once weekly for 16 weeks
828732|NCT01298518|B4|Baseline|Total|Total of all reporting groups
828733|NCT01298518|B3|Baseline|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828734|NCT01298518|B2|Baseline|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828735|NCT01298518|B1|Baseline|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828736|NCT01298518|P3|Participant Flow|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828737|NCT01298518|P2|Participant Flow|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828738|NCT01298518|P1|Participant Flow|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828739|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828740|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828741|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828742|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828743|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828781|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828744|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828745|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828746|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828747|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828748|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828749|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828750|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828751|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828752|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828753|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828754|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828755|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828756|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828757|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828758|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828759|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828760|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828761|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828762|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828763|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828764|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828765|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828766|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828767|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828768|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828769|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828770|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828771|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828772|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828773|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828774|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828775|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828776|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828777|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828778|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828779|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828782|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828783|NCT01298518|O3|Outcome|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828784|NCT01298518|O2|Outcome|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828785|NCT01298518|O1|Outcome|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828786|NCT01298518|E3|Reported Event|Placebo|Matching placebo orally twice daily (BID) for 4 weeks.
828787|NCT01298518|E2|Reported Event|PF-04620110 5 mg QD|PF-04620110 5 mg orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for 4 weeks.
828788|NCT01298518|E1|Reported Event|PF-04620110 2.5 mg QD, Then PF-04620110 2.5 mg BID|PF-04620110 2.5 milligram (mg) orally once daily (QD) in the morning and matching placebo orally once daily (QD) in the evening for Week 1 and 2, followed by PF-04620110 2.5 mg orally twice daily (BID) for Week 3 and 4.
828789|NCT01298362|B3|Baseline|Total|Total of all reporting groups
828790|NCT01298362|B2|Baseline|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828791|NCT01298362|B1|Baseline|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828792|NCT01298362|P2|Participant Flow|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828793|NCT01298362|P1|Participant Flow|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828794|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828795|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828796|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828797|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828798|NCT01298362|O2|Outcome|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828799|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828800|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828801|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828802|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828803|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828804|NCT01298362|O2|Outcome|HT Cohort|In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828805|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828806|NCT01298362|O2|Outcome|HT Cohort|"In the HT cohort patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.~The primary outcome variable was the mean percentage change in LS BMD between the pre CT treatment measurement and the post 12 months AI measurements in the CT cohort. The HT cohort was included as a control group.~BMD measurements in HT cohort were taken before AI start and at 12 months."
828807|NCT01298362|O1|Outcome|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828808|NCT01298362|E2|Reported Event|HT Cohort|Patients were treated with a third generation AI, as adjuvant therapy (HT cohort) and were followed up for a 12-month period.
828809|NCT01298362|E1|Reported Event|CT Cohort|Patients were treated with a third generation AI, as subsequent endocrine therapy after initial treatment with chemotherapy (CT cohort), and were followed up for a 12-month period.
828810|NCT01298323|B3|Baseline|Total|Total of all reporting groups
828811|NCT01298323|B2|Baseline|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
828812|NCT01298323|B1|Baseline|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
828813|NCT01298323|P2|Participant Flow|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
828814|NCT01298323|P1|Participant Flow|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
828815|NCT01298323|O2|Outcome|Vandetanib 300 mg|Patients on this arm will get a standard AE monitoring schedule, similar to that used on previous studies. Patients will be asked about any AEs at scheduled visits and will have the option to contact the investigator at any time if experiencing any AE or symptoms and discuss the best treatment options.
828856|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
829219|NCT01296698|E1|Reported Event|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
828816|NCT01298323|O1|Outcome|Vandetanib 300 mg+Outreach Program|Patients on this arm will be contacted by site personnel at week 1 and then every 2 weeks during the first 52 weeks on the study (or prior discontinuation) to detect and possibly treat adverse events sooner than they might have been without the patient outreach, and at a time of lesser CTCAE grade.
828817|NCT01298323|E2|Reported Event|Vandetanib 300mg + Outreach Program|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
828818|NCT01298323|E1|Reported Event|Vandetanib 300mg|Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily
828819|NCT01298167|B3|Baseline|Total|Total of all reporting groups
828820|NCT01298167|B2|Baseline|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
828821|NCT01298167|B1|Baseline|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
828822|NCT01298167|P2|Participant Flow|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
828823|NCT01298167|P1|Participant Flow|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
828824|NCT01298167|O2|Outcome|FAG Superior/Inferior|Combined measures of Fast Absorbing Gut Suture used on both the superior and inferior halves of wounds.
828825|NCT01298167|O1|Outcome|Cyanoacrylate Superior/Inferior|Combined measures of Cyanoacrylate used on both the superior and inferior halves of wounds.
828826|NCT01298167|E2|Reported Event|FAG Superior ½ of Wound & Cyanoacrylate Inferior ½ of Wound|Patients wounds were divided in half and Fast Acting Gut Suture was utilized for the superior ½ of the wound & Cyanoacrylate was utilized for inferior ½ of wound.
828827|NCT01298167|E1|Reported Event|Cyanoacrylate Superior ½ of Wound & FAG Inferior ½ of Wound|Patients wounds were divided in half and Cyanoacrylate was utilized for the superior ½ of the wound & Fast Acting Gut Suture was utilized for inferior ½ of wound.
828828|NCT01298128|B3|Baseline|Total|Total of all reporting groups
828829|NCT01298128|B2|Baseline|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
828835|NCT01298128|E2|Reported Event|Combined Oral Contraceptive Pill|OCP for IVF pre-treatment
828836|NCT01298128|E1|Reported Event|NuvaRing|NuvaRing for IVF pre-treatment
828837|NCT01298063|B6|Baseline|Total|Total of all reporting groups
828838|NCT01298063|B5|Baseline|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
828839|NCT01298063|B4|Baseline|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
828840|NCT01298063|B3|Baseline|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
828841|NCT01298063|B2|Baseline|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
828842|NCT01298063|B1|Baseline|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
828843|NCT01298063|P5|Participant Flow|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
828844|NCT01298063|P4|Participant Flow|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
828845|NCT01298063|P3|Participant Flow|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
828846|NCT01298063|P2|Participant Flow|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
828847|NCT01298063|P1|Participant Flow|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
828848|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
828849|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
828850|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
828851|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
828852|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
828853|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
828854|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
828855|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
829220|NCT01296646|B3|Baseline|Total|Total of all reporting groups
828857|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
828858|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
828859|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
828860|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
828861|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
828862|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
828863|NCT01298063|O5|Outcome|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
828864|NCT01298063|O4|Outcome|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
828865|NCT01298063|O3|Outcome|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
828866|NCT01298063|O2|Outcome|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
828867|NCT01298063|O1|Outcome|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 milligram (mg) Afatinib (One tablet qd in the morning).
828868|NCT01298063|E5|Reported Event|50 mg Afatinib Group D|Group D: Subjects with normal hepatic function matching to subjects in group B2 were treated with 50 mg Afatinib (One tablet qd in the morning).
828869|NCT01298063|E4|Reported Event|50 mg Afatinib Group C|Group C: Subjects with normal hepatic function matching to subjects in group A were treated with 50 mg Afatinib (One tablet qd in the morning).
828870|NCT01298063|E3|Reported Event|50 mg Afatinib Group B2|Group B2: Moderate hepatic impaired subjects with Child Pugh B were treated with 50 mg Afatinib (One tablet qd in the morning).
828871|NCT01298063|E2|Reported Event|30 mg Afatinib Group B1|Group B1: Moderate hepatic impaired subjects with Child Pugh B were treated with 30 mg Afatinib (One tablet qd in the morning).
828872|NCT01298063|E1|Reported Event|50 mg Afatinib Group A|Group A: Mild hepatic impaired subjects with Child Pugh A were treated with 50 mg Afatinib (One tablet qd in the morning).
828873|NCT01297920|B4|Baseline|Total|Total of all reporting groups
828874|NCT01297920|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
828875|NCT01297920|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
828876|NCT01297920|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
828877|NCT01297920|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
828878|NCT01297920|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
828879|NCT01297920|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
828880|NCT01297920|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
828881|NCT01297920|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
828882|NCT01297920|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
828883|NCT01297920|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, 1 drop instilled in each eye 3 times a day for 3 months
828884|NCT01297920|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, 1 drop instilled in each eye 3 times a day for 3 months
828885|NCT01297920|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, 1 drop instilled in each eye 3 times a day for 3 months
828886|NCT01297595|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg FC first and crizotinib 250 mg OLF first.
828887|NCT01297595|P2|Participant Flow|Crizotinib 250 mg OLF First, Then Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg OLF in first intervention period; and single oral dose of crizotinib 250 mg FC in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
828888|NCT01297595|P1|Participant Flow|Crizotinib 250 mg FC First, Then Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 milligram (mg) formulated capsule (FC) in first intervention period; and single oral dose of crizotinib 250 mg oral liquid formulation (OLF) in second intervention period. A washout period of at least 14 days was maintained between each crizotinib dose.
828889|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828890|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828891|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828892|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828893|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828894|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828895|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828897|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828898|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828899|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828900|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828901|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828902|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828903|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828904|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828905|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828906|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828907|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828908|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828909|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828910|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828911|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828912|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828913|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828914|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828915|NCT01297595|O2|Outcome|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828916|NCT01297595|O1|Outcome|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828917|NCT01297595|E2|Reported Event|Crizotinib 250 mg OLF|Single oral dose of crizotinib 250 mg OLF [Test] in either first intervention period or second intervention period.
828918|NCT01297595|E1|Reported Event|Crizotinib 250 mg FC|Single oral dose of crizotinib 250 mg FC [Reference] in either first intervention period or second intervention period.
828919|NCT01297517|B4|Baseline|Total|Total of all reporting groups
828920|NCT01297517|B3|Baseline|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828921|NCT01297517|B2|Baseline|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828922|NCT01297517|B1|Baseline|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828923|NCT01297517|P3|Participant Flow|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828924|NCT01297517|P2|Participant Flow|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828925|NCT01297517|P1|Participant Flow|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828926|NCT01297517|O3|Outcome|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828927|NCT01297517|O2|Outcome|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828928|NCT01297517|O1|Outcome|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828929|NCT01297517|E3|Reported Event|Brimonidine|Brimonidine tartrate ophthalmic solution, 0.2%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828930|NCT01297517|E2|Reported Event|Brinzolamide|Brinzolamide ophthalmic suspension, 1%, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828931|NCT01297517|E1|Reported Event|Brinzolamide/Brimonidine|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension, one drop instilled in each eye three times a day (8 am, 3 pm, 10 pm) for three months
828932|NCT01297504|B1|Baseline|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
828933|NCT01297504|P1|Participant Flow|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
828934|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
828935|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
829221|NCT01296646|B2|Baseline|Naltrexone|50 mg of naltrexone orally daily.
828936|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
828937|NCT01297504|O2|Outcome|Multivariate|
828938|NCT01297504|O1|Outcome|Univariate|
828939|NCT01297504|O2|Outcome|LTRI Due to RSV|Hospitalizations due to lower respiratory tract infections (LRTI) caused by RSV
828940|NCT01297504|O1|Outcome|LTRI|Hospitalizations due to lower respiratory tract infections (LRTI).
828941|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
828942|NCT01297504|O1|Outcome|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
828943|NCT01297504|E1|Reported Event|Palivizumab|Infants at risk for respiratory syncytial virus infection received palivizumab prescribed in accordance with the terms of the local marketing authorization.
828944|NCT01297491|B3|Baseline|Total|Total of all reporting groups
828945|NCT01297491|B2|Baseline|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828946|NCT01297491|B1|Baseline|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828947|NCT01297491|P2|Participant Flow|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828948|NCT01297491|P1|Participant Flow|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828949|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828950|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828951|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828952|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828953|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828954|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828955|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828956|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828957|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828958|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828959|NCT01297491|O2|Outcome|Non-Squamous BKM120 100mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828960|NCT01297491|O1|Outcome|Squamous BKM120 100mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828961|NCT01297491|E2|Reported Event|Non-Squamous BKM120 100 mg qd|Diagnosed patients with non-squamous NSCLC that progressed after one or two prior antineoplastic therapy lines for metastatic disease.
828962|NCT01297491|E1|Reported Event|Squamous BKM120 100 mg qd|Diagnosed patients with non-small cell lung cancer (NSCLC) that progressed after one prior, platinum-based chemotherapy line for metastatic disease.
828963|NCT01297465|B3|Baseline|Total|Total of all reporting groups
828964|NCT01297465|B2|Baseline|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828965|NCT01297465|B1|Baseline|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828966|NCT01297465|P2|Participant Flow|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
829012|NCT01297335|P1|Participant Flow|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
829222|NCT01296646|B1|Baseline|Placebo|Placebo taken once daily.
828967|NCT01297465|P1|Participant Flow|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828968|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828969|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828970|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828971|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828972|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828973|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828974|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828975|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828976|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828977|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828978|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
829013|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subjects were asked to rate both level of sedation and dryness of their mouths (two of the most common side effects of clonidine) at before clonidine injection (baseline) and at one hour after clonidine injection (Post injection) on VAS scale. VAS scale is an analogue scale that measures subject response from 0 to 10 cm, where larger value represents greater level of sedation and dryness in the mouth subject experienced.
829223|NCT01296646|P2|Participant Flow|Naltrexone|50 mg of naltrexone orally daily.
828979|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828980|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828981|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828982|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828983|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828984|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828985|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828986|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828987|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828988|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828989|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828990|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
829014|NCT01297335|O1|Outcome|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
829224|NCT01296646|P1|Participant Flow|Placebo|Placebo taken once daily.
828991|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828992|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828993|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828994|NCT01297465|O2|Outcome|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828995|NCT01297465|O1|Outcome|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828996|NCT01297465|E2|Reported Event|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU was administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). On r-hCG (Ovidrel®/Ovitrelle®) day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
828997|NCT01297465|E1|Reported Event|Gonal-f® Plus Pergoveris®|Gonal-f® (follitropin alfa) 300 International Unit (IU) was administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5) followed by subsequent daily administration of Pergoveris® (follitropin alfa and lutropin alfa) 300 IU subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) (Ovidrel®/Ovitrelle®) administration day (at least 1 follicles greater than or equal to (>=) 18 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously. The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
828998|NCT01297348|B3|Baseline|Total|Total of all reporting groups
828999|NCT01297348|B2|Baseline|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
829000|NCT01297348|B1|Baseline|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
829001|NCT01297348|P2|Participant Flow|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
829002|NCT01297348|P1|Participant Flow|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
829003|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
829004|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
829005|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
829006|NCT01297348|O3|Outcome|Other OCs: Levonorgestrel, Ethinyl Estradiol 20 Mcg (Levo-20)|A subset of EE-20 group including participants who were current or past users of Levo-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and differing concentrations of levonorgestrel (progestin), were observed.
829007|NCT01297348|O2|Outcome|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
829008|NCT01297348|O1|Outcome|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
829009|NCT01297348|E2|Reported Event|Other OCs: Ethinyl Estradiol 20 Mcg (EE-20)|Participants who were current or past users of EE-20, cyclic oral contraceptives (OCs) containing ethinyl estradiol 20 mcg and a progestin, were observed.
829010|NCT01297348|E1|Reported Event|Lybrel|Participants who were current or past users of Lybrel, a continuous use oral contraceptive containing levonorgestrel 90 microgram (mcg) and ethinyl estradiol 20 mcg, were observed.
829011|NCT01297335|B1|Baseline|Intrathecal Clonidine|All subjects met all inclusion and exclusionary criteria, and we report study subjects' demographic information in following sections.
829015|NCT01297335|O1|Outcome|Intrathecal Clonidine|Subject received one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg were delivered. Supine and sitting blood pressures and heart rate were measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.
829016|NCT01297335|E1|Reported Event|Intrathecal Clonidine|"Subject will receive one time Clonidine injection via lower lumber interspace. Clonidine (Duraclon), 100 μg/ml, 1.5 ml will be diluted to 2 ml with preservative free saline, and total of 150 μg will be delivered. Supine and sitting blood pressures and heart rate will be measured at 10 minute intervals until 60 minutes after clonidine administration, then at 15 minutes for next 3 hours.~clonidine: Intrathecal Clonidine"
829017|NCT01297322|B3|Baseline|Total|Total of all reporting groups
829018|NCT01297322|B2|Baseline|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829019|NCT01297322|B1|Baseline|Manual Compression|Manual compression: Standard of Care
829020|NCT01297322|P2|Participant Flow|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829021|NCT01297322|P1|Participant Flow|Manual Compression|Manual compression: Standard of Care
829022|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829023|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829024|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829025|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829026|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829027|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829028|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829029|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829030|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829031|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829032|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829033|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829034|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829035|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829036|NCT01297322|O2|Outcome|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829037|NCT01297322|O1|Outcome|Manual Compression|Manual compression: Standard of Care
829038|NCT01297322|E2|Reported Event|VASCADE™ Vascular Closure System|Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
829039|NCT01297322|E1|Reported Event|Manual Compression|Manual compression: Standard of Care
829040|NCT01297283|B1|Baseline|Overall Subjects|
829041|NCT01297283|P1|Participant Flow|Overall Subjects|Measurement of pacing thresholds are done first with the support of a leadless ECG provided by the implanted device
829042|NCT01297283|O1|Outcome|Overall Subjects|
829043|NCT01297283|O1|Outcome|Overall Subjects|
829044|NCT01297283|E1|Reported Event|Overall Subjects|
829045|NCT01297270|B4|Baseline|Total|Total of all reporting groups
829046|NCT01297270|B3|Baseline|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829047|NCT01297270|B2|Baseline|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829048|NCT01297270|B1|Baseline|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829049|NCT01297270|P3|Participant Flow|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829050|NCT01297270|P2|Participant Flow|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829051|NCT01297270|P1|Participant Flow|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir (BI 201335) 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829052|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829053|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829054|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829055|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829056|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829057|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829058|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829059|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829060|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829061|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829062|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829063|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829064|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829065|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829124|NCT01297062|E3|Reported Event|Moxifloxacin|Moxifloxacin with placebo infusion
829066|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829067|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829068|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829069|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829070|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829071|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829072|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829073|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829074|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829075|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829076|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829077|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829078|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829154|NCT01296763|P2|Participant Flow|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
829079|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829080|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829081|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829082|NCT01297270|O3|Outcome|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829083|NCT01297270|O2|Outcome|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829084|NCT01297270|O1|Outcome|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829085|NCT01297270|E3|Reported Event|Placebo and PegIFN/RBV|Placebo (oral) once daily combined with PegIFN/RBV (subcutaneous injection) for 24 weeks, followed by an additional 24 weeks of PegIFN/RBV (oral) alone.
829086|NCT01297270|E2|Reported Event|Faldaprevir 240mg and PegIFN/RBV|Faldaprevir 240 mg once daily (oral), for 12 weeks, with PegIFN/RBV (subcutaneous injection/oral). Followed by an additional 12 weeks of placebo plus PegIFN/RBV. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829087|NCT01297270|E1|Reported Event|Faldaprevir 120mg and PegIFN/RBV|Faldaprevir 120 mg once daily (oral), for 24 weeks, with Pegylated interferon α-2a (PegIFN/RBV), subcutaneous injection/oral. At week 24, if the patients did not achieve early treatment success (ETS) the patient received an additional 24 weeks of PegIFN/RBV alone.
829088|NCT01297257|B1|Baseline|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
829089|NCT01297257|P1|Participant Flow|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
829090|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
829091|NCT01297257|O1|Outcome|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7,740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 10,733 Resolute Integrity™ Stents
829092|NCT01297257|E1|Reported Event|Group 1 Resolute Integrity™ Stent Primary Stent|A total of 7740 subjects were included in the intention-to-treat analysis. These subjects had 10,499 lesions which were treated with 12,165 stents.
829093|NCT01297062|B7|Baseline|Total|Total of all reporting groups
829094|NCT01297062|B6|Baseline|Exenatide-Placebo-Moxifloxacin Sequence|Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III
829095|NCT01297062|B5|Baseline|Placebo-Moxifloxacin-Exenatiden Sequence|Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III
829096|NCT01297062|B4|Baseline|Moxifloxacin-Exenatide-Placebo Sequence|Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III
829097|NCT01297062|B3|Baseline|Moxifloxacin-Placebo-Exenatide Sequence|Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III
829098|NCT01297062|B2|Baseline|Exenatide-Moxifloxacin-Placebo Sequence|Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III
829099|NCT01297062|B1|Baseline|Placebo-Exenatide-Moxifloxacin Sequence|Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III
829100|NCT01297062|P7|Participant Flow|Non-Randomized|Not Randomized
829101|NCT01297062|P6|Participant Flow|Exenatide-Placebo-Moxifloxacin Sequence|"Exenatide in Period I; Placebo comparator in Period II; Moxifloxacin with placebo infusion in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
829102|NCT01297062|P5|Participant Flow|Placebo-Moxifloxacin-Exenatiden Sequence|"Placebo comparator in Period I; Moxifloxacin with placebo infusion in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
829103|NCT01297062|P4|Participant Flow|Moxifloxacin-Exenatide-Placebo Sequence|"Moxifloxacin with placebo infusion in Period I; Exenatide in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
829153|NCT01296763|P3|Participant Flow|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
829104|NCT01297062|P3|Participant Flow|Moxifloxacin-Placebo-Exenatide Sequence|"Moxifloxacin with placebo infusion in Period I; Placebo comparator in Period II; Exenatide in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
829105|NCT01297062|P2|Participant Flow|Exenatide-Moxifloxacin-Placebo Sequence|"Exenatide in Period I; Moxifloxacin with placebo infusion in Period II; Placebo comparator in Period III~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
829106|NCT01297062|P1|Participant Flow|Placebo-Exenatide-Moxifloxacin Sequence|"Placebo comparator in Period I; Exenatide in Period II; Moxifloxacin with placebo infusion in Period III;~Exenatide - stepped intravenous (IV) infusion to gradually deliver levels of exenatide at concentrations of approximately 200 pg/mL (Day 1), 300 pg/mL (Day 2), and 500 pg/mL (Day 3)~Moxifloxacin - Placebo intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) with single oral dose of Moxifloxacin (400 mg) on Day 2~Placebo - intravenously infused at the same volume rate (mL/min) as that of active study medication (exenatide) on Day 1, Day 2, and Day 3"
829107|NCT01297062|O1|Outcome|Exenatide|Exenatide
829108|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829109|NCT01297062|O1|Outcome|Exenatide|Exenatide
829110|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829111|NCT01297062|O1|Outcome|Exenatide|Exenatide
829112|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829113|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
829114|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829115|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
829116|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829117|NCT01297062|O1|Outcome|Moxifloxacin|Moxifloxacin with placebo infusion
829118|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829119|NCT01297062|O1|Outcome|Exenatide|Exenatide
829120|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829121|NCT01297062|O1|Outcome|Exenatide|Exenatide
829122|NCT01297062|O2|Outcome|Placebo|Placebo Comparator
829128|NCT01296841|B2|Baseline|Telemedicine Encounter|Remote clinical appointment between patient and physician.
829129|NCT01296841|B1|Baseline|Standard Encounter|"Standard in-house clinical visit between patient and physician."
829130|NCT01296841|P2|Participant Flow|Telemedicine Encounter|Remote clinical appointment between patient and physician.
829131|NCT01296841|P1|Participant Flow|Standard Encounter|"Standard in-house clinical visit between patient and physician."
829132|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
829133|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
829134|NCT01296841|O2|Outcome|Telemedicine Encounter|Remote clinical appointment between patient and physician.
829135|NCT01296841|O1|Outcome|Standard Encounter|"Standard in-house clinical visit between patient and physician."
829136|NCT01296841|O2|Outcome|Standard|clinic experience (mean±SD)
829137|NCT01296841|O1|Outcome|Telemedicine|clinic experience (mean ± SD, 1 excellent, 5 poor)
829138|NCT01296841|E2|Reported Event|Telemedicine Encounter|Remote clinical appointment between patient and physician.
829139|NCT01296841|E1|Reported Event|Standard Encounter|"Standard in-house clinical visit between patient and physician."
829140|NCT01296815|B3|Baseline|Total|Total of all reporting groups
829141|NCT01296815|B2|Baseline|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
829142|NCT01296815|B1|Baseline|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
829143|NCT01296815|P2|Participant Flow|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
829144|NCT01296815|P1|Participant Flow|HAART|Patients received antiretroviral treatment according to the Guidelines for the Use of Antiretroviral Agents in HIV-1-Infected Adults and Adolescents
829145|NCT01296815|O2|Outcome|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
829146|NCT01296815|O1|Outcome|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
829147|NCT01296815|E2|Reported Event|HAART+ Bevacizumab Injection|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
829148|NCT01296815|E1|Reported Event|HAART|Bevacizumab: Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
829149|NCT01296763|B4|Baseline|Total|Total of all reporting groups
829150|NCT01296763|B3|Baseline|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
829151|NCT01296763|B2|Baseline|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
829152|NCT01296763|B1|Baseline|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
829155|NCT01296763|P1|Participant Flow|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
829156|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
829157|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
829158|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
829159|NCT01296763|O3|Outcome|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
829160|NCT01296763|O2|Outcome|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
829161|NCT01296763|O1|Outcome|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
829162|NCT01296763|E3|Reported Event|Dose Level 5|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Mitomycin 5 mg/m2 IV, Day 1~Olaparib 100 mg bid oral, Days 1 and 8"
829163|NCT01296763|E2|Reported Event|Dose Level 2|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100mg bid oral, Day 1-3, Day 8-10"
829164|NCT01296763|E1|Reported Event|Dose Level 1|"Irinotecan 70 mg/m2 IV, Days 1 and 8~Cisplatin 25 mg/m2 IV, Days 1 and 8~Olaparib 100 mg bid oral, Days 1 and 8"
829165|NCT01296698|B3|Baseline|Total|Total of all reporting groups
829166|NCT01296698|B2|Baseline|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829167|NCT01296698|B1|Baseline|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829168|NCT01296698|P2|Participant Flow|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829169|NCT01296698|P1|Participant Flow|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829170|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829171|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829172|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829173|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829174|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829175|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829176|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829177|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829178|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829179|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829180|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829181|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829182|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829183|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829184|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829185|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829186|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829187|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829188|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829189|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829190|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829191|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829192|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829193|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829194|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829195|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829196|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829197|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829198|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829199|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829200|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829201|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829202|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829203|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829204|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829205|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829206|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829207|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829208|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829209|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829210|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829211|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829212|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829213|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829214|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829215|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829216|NCT01296698|O2|Outcome|Nicotine|1 mg Oral NRT, up to 4 times per hour for 12 weeks
829217|NCT01296698|O1|Outcome|Placebo|0 mg Oral NRT, up to 4 times per hour for 12 weeks
829229|NCT01296646|E2|Reported Event|Naltrexone|50 mg of naltrexone orally daily.
829230|NCT01296646|E1|Reported Event|Placebo|Placebo taken once daily.
829231|NCT01296412|B3|Baseline|Total|Total of all reporting groups
829232|NCT01296412|B2|Baseline|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
829233|NCT01296412|B1|Baseline|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
829234|NCT01296412|P2|Participant Flow|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
829235|NCT01296412|P1|Participant Flow|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
829236|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
829237|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
829238|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
829239|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
829240|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
829241|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
829242|NCT01296412|O2|Outcome|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
829243|NCT01296412|O1|Outcome|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
829244|NCT01296412|E2|Reported Event|Liraglutide|Liraglutide subcutaneous injection once daily for 26 weeks (starting dose 0.6 mg daily up-titrated to 1.2 mg daily on Day 8). Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have had their liraglutide dose uptitrated to 1.8 mg daily for glycemic control.
829245|NCT01296412|E1|Reported Event|Sitagliptin +/- Glimepiride|Sitagliptin 100 mg tablet once daily for 26 weeks. Participants continued their stable dose of metformin >=1500 mg orally daily. Participants may have received glimepiride for glycemic control.
829246|NCT01296360|B3|Baseline|Total|Total of all reporting groups
829247|NCT01296360|B2|Baseline|Non-Booster Group|No treatment in study IC51-325
829248|NCT01296360|B1|Baseline|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
829249|NCT01296360|P2|Participant Flow|Non-Booster Group|No treatment in study IC51-325
829250|NCT01296360|P1|Participant Flow|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
829251|NCT01296360|O2|Outcome|>3 Years - <18 Years|booster vaccination: IXIARO 0.5 ml i.m (milliliter, intramuscular)
829252|NCT01296360|O1|Outcome|>14 Months to <2 Years|booster vaccination: IXIARO 0.25 ml i.m. (milliliter, intramuscular)
829253|NCT01296360|E2|Reported Event|Non-Booster Group|No treatment in study IC51-325
829254|NCT01296360|E1|Reported Event|Booster Group|IC51 booster vaccination ~12 months after primary immunization in study IC51-323
829255|NCT01296347|B3|Baseline|Total|Total of all reporting groups
829256|NCT01296347|B2|Baseline|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
829257|NCT01296347|B1|Baseline|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
829258|NCT01296347|P2|Participant Flow|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
829259|NCT01296347|P1|Participant Flow|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
829260|NCT01296347|O2|Outcome|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
829261|NCT01296347|O1|Outcome|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
829262|NCT01296347|E2|Reported Event|Ketamine|"Patients will receive intravenous ketamine, starting 10 minutes prior to surgery and will continue for 96 hours~Ketamine: Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion"
829263|NCT01296347|E1|Reported Event|Saline|Patients will receive a placebo infusion of 0.9% sodium chloride, which will start 10 minutes prior to the start of the operation and continue for 96 hours.
829264|NCT01296152|B1|Baseline|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
829265|NCT01296152|P1|Participant Flow|Depo-medroxyprogesterone Acetate (DMPA)|"At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~depo-medroxyprogesterone acetate: At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.~Depo-medroxyprogesterone Acetate"
829266|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829267|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829268|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829269|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829270|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829271|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829272|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829273|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829274|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829315|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
829275|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829276|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829277|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829278|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829279|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829280|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829281|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829282|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829283|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829284|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829285|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829286|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829287|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829288|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829289|NCT01296152|O1|Outcome|Depo-medroxyprogesterone Acetate (DMPA)|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829290|NCT01296152|E1|Reported Event|Arm A|At study entry/ Day 0, subjects will receive depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
829291|NCT01296035|B1|Baseline|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
829292|NCT01296035|P1|Participant Flow|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
829293|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
829294|NCT01296035|O1|Outcome|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
829295|NCT01296035|E1|Reported Event|Panitumuab and Gemcitabine|Panitumumab: Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
829296|NCT01295905|B3|Baseline|Total|Total of all reporting groups
829297|NCT01295905|B2|Baseline|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829298|NCT01295905|B1|Baseline|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829299|NCT01295905|P2|Participant Flow|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829300|NCT01295905|P1|Participant Flow|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829301|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829302|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829303|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829304|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829305|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829306|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829307|NCT01295905|O2|Outcome|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829308|NCT01295905|O1|Outcome|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829309|NCT01295905|E2|Reported Event|Narafilcon B|Commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829310|NCT01295905|E1|Reported Event|Delefilcon A|Investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 3 months.
829311|NCT01295879|B1|Baseline|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
829312|NCT01295879|P1|Participant Flow|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
829313|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
829314|NCT01295879|O1|Outcome|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
829316|NCT01295879|E1|Reported Event|Ergocalciferol|Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
829317|NCT01295840|B1|Baseline|No Arms|All patient have a Quartet LV lead. No arms.
829318|NCT01295840|P1|Participant Flow|No Arms|All patient have a Quartet Left Ventricular (LV) lead. No arms.
829319|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829320|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829321|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829322|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829323|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829324|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829325|NCT01295840|O1|Outcome|Quartet LV Lead|All patient have a Quartet LV lead. No arms
829326|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829327|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829328|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms
829329|NCT01295840|O1|Outcome|No Arms|All patient have a Quartet LV lead. No arms.
829330|NCT01295840|E1|Reported Event|No Arms|All patient have a Quartet LV lead. No arms
829331|NCT01295814|B3|Baseline|Total|Total of all reporting groups
829332|NCT01295814|B2|Baseline|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829333|NCT01295814|B1|Baseline|Inactive Drug|inactive drug : placebo
829334|NCT01295814|P2|Participant Flow|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829335|NCT01295814|P1|Participant Flow|Inactive Drug|inactive drug : placebo
829336|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829337|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
829338|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829339|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
829340|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829341|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
829342|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829343|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
829344|NCT01295814|O2|Outcome|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829345|NCT01295814|O1|Outcome|Inactive Drug|inactive drug : placebo
829346|NCT01295814|E2|Reported Event|Adalimumab|Adalimumab : 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
829347|NCT01295814|E1|Reported Event|Inactive Drug|inactive drug : placebo
829348|NCT01295281|B3|Baseline|Total|Total of all reporting groups
829349|NCT01295281|B2|Baseline|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
829350|NCT01295281|B1|Baseline|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
829351|NCT01295281|P2|Participant Flow|LoFric PVC - POBE 2.0|"First period (7 days) use of LoFric PVC followed by second period (7 days) use of LoFric POBE 2.0.~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
829352|NCT01295281|P1|Participant Flow|LoFric POBE 2.0 - PVC|"First period (7 days) use of LoFric POBE 2.0 followed by second period (7 days) use of LoFric PVC~LoFric POBE 2.0: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.~LoFric PVC: To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively."
829353|NCT01295281|O2|Outcome|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
829354|NCT01295281|O1|Outcome|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
829355|NCT01295281|E2|Reported Event|LoFric PVC|Single use LoFric PVC catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
829356|NCT01295281|E1|Reported Event|LoFric POBE 2.0|Single use LoFric POBE 2.0 catheters were used for intermittent catheterization at least twice daily for seven days. Catheterization was performed by the subjects themselves in a home setting.
829357|NCT01295216|B3|Baseline|Total|Total of all reporting groups
829358|NCT01295216|B2|Baseline|Control|Individuals who receive the usual primary health care
829359|NCT01295216|B1|Baseline|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829360|NCT01295216|P2|Participant Flow|Control|Individuals who receive the usual primary health care
829554|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829361|NCT01295216|P1|Participant Flow|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829362|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
829363|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829364|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
829365|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829366|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
829367|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829368|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
829369|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829370|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
829371|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829372|NCT01295216|O2|Outcome|Control|Individuals who receive the usual primary health care
829373|NCT01295216|O1|Outcome|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829374|NCT01295216|E2|Reported Event|Control|Individuals who receive the usual primary health care
829407|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829408|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829375|NCT01295216|E1|Reported Event|Intervention|"Pre-hypertensive subjects who receive mHealth support for 12 months~Mobile technology to promote lifestyle modification: Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants"
829376|NCT01295034|B3|Baseline|Total|Total of all reporting groups
829377|NCT01295034|B2|Baseline|Tiered/Titrated Vitamin B Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
829378|NCT01295034|B1|Baseline|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
829379|NCT01295034|P2|Participant Flow|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
829380|NCT01295034|P1|Participant Flow|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
829381|NCT01295034|O2|Outcome|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
829382|NCT01295034|O1|Outcome|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
829383|NCT01295034|O2|Outcome|Tiered/Titrated Vitamin D Dosing|tiered/titrated vitamin D dosing: Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
829384|NCT01295034|O1|Outcome|Conventional Vitamin D Treatment|conventional vitamin D treatment: Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
829385|NCT01295034|E2|Reported Event|Tiered/Titrated Vitamin B Dosing|Subjects in Protocol B received 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
829386|NCT01295034|E1|Reported Event|Conventional Vitamin B Dosing|Subjects in Protocol A (the conventional/active placebo arm) received 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
829426|NCT01294787|B1|Baseline|All Participants|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods. One participant was randomized but did not receive study drug.
829387|NCT01294917|B1|Baseline|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
829388|NCT01294917|P1|Participant Flow|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
829389|NCT01294917|O3|Outcome|OptiFree RepleniSH MPS|All subjects received the OptiFree RepleniSH MPS for one month for the care of their soft contact lenses.
829390|NCT01294917|O2|Outcome|Clear Care|All subjects received the Clear Care for one month for the care of their soft contact lenses.
829391|NCT01294917|O1|Outcome|AMO Investigational MPS|All subjects received the AMO Investigational MPS for one month for the care of their soft contact lenses.
829392|NCT01294917|E1|Reported Event|All Participants|All subjects received each of 3 study solutions for one month each for the daily care of their soft contact lenses. Subjects were randomized to six possible sequences of use of each study solution: AMO Investigational MPS, Clear Care and OptiFree ReplenisH MPS.
829393|NCT01294800|B5|Baseline|Total|Total of all reporting groups
829394|NCT01294800|B4|Baseline|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829395|NCT01294800|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829396|NCT01294800|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829397|NCT01294800|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
829398|NCT01294800|P4|Participant Flow|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829399|NCT01294800|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829400|NCT01294800|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829401|NCT01294800|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg taken orally twice daily (BID), one tablet in the morning and one tablet in the evening, for 12 weeks.
829402|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829403|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829404|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829405|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829406|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829409|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829410|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829411|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829412|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829413|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829414|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829415|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829416|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829417|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829418|NCT01294800|O4|Outcome|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829419|NCT01294800|O3|Outcome|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829420|NCT01294800|O2|Outcome|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829421|NCT01294800|O1|Outcome|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829422|NCT01294800|E4|Reported Event|Placebo|Participants received a placebo to preladenant tablet taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829423|NCT01294800|E3|Reported Event|Preladenant 10 mg|Participants received preladenant 10 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829424|NCT01294800|E2|Reported Event|Preladenant 5 mg|Participants received preladenant 5 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829425|NCT01294800|E1|Reported Event|Preladenant 2 mg|Participants received preladenant 2 mg taken orally BID, one tablet in the morning and one tablet in the evening, for 12 weeks.
829427|NCT01294787|P6|Participant Flow|Tiotropium / Placebo / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
829428|NCT01294787|P5|Participant Flow|Tiotropium / QAV149 / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
829429|NCT01294787|P4|Participant Flow|Placebo / Tiotropium / QVA149|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
829430|NCT01294787|P3|Participant Flow|Placebo / QVA149 / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
829431|NCT01294787|P2|Participant Flow|QVA149 / Tiotropium / Placebo|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
829432|NCT01294787|P1|Participant Flow|QVA149 / Placebo / Tiotropium|Participants received three, 3-week treatment periods followed by a study completion evaluation. A washout of 21 days was used to separate the treatment periods.
829433|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829434|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829435|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829436|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829437|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
829438|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
829439|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829440|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829441|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
829442|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829443|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829444|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
829445|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829446|NCT01294787|O1|Outcome|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
829447|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829448|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829449|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829450|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829451|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829452|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829453|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829454|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829455|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829456|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829457|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829458|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829459|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829460|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829461|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829462|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829463|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829464|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829465|NCT01294787|O3|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
829466|NCT01294787|O2|Outcome|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829467|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829468|NCT01294787|O2|Outcome|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler
829469|NCT01294787|O1|Outcome|QVA149|Indacaterol and glycopyrronium bromide (QVA149) delivered once daily via single-dose dry powder inhaler.
829470|NCT01294787|E3|Reported Event|Placebo|Placebo, delivered once daily via single-dose dry powder inhaler.
829471|NCT01294787|E2|Reported Event|Tiotropium|Tiotropium delivered once daily via HandiHaler® device.
829472|NCT01294787|E1|Reported Event|Indacaterol and Glycopyrronium Bromide (QVA149)|QVA149 delivered once daily via single-dose dry powder inhaler.
829473|NCT01294748|B3|Baseline|Total|Total of all reporting groups
829474|NCT01294748|B2|Baseline|Endeavor DES|Active Comparator: Endeavor DES
829475|NCT01294748|B1|Baseline|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829476|NCT01294748|P2|Participant Flow|Endeavor DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829477|NCT01294748|P1|Participant Flow|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829478|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829479|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829480|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829481|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829482|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829483|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829484|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829485|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829486|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829487|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829488|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829489|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829490|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829491|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829492|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829493|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829494|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829495|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829496|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829497|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829498|NCT01294748|O2|Outcome|Endeavor DES|Active Comparator: Endeavor DES
829499|NCT01294748|O1|Outcome|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829500|NCT01294748|E2|Reported Event|Endeavor DES|Active Comparator: Endeavor DES
829501|NCT01294748|E1|Reported Event|MiStent DES|MiStent DES: The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
829502|NCT01294709|B1|Baseline|All Enrolled Participants|All enrolled participants who recieved at least one dose of either telcagepant or placebo.
829503|NCT01294709|P2|Participant Flow|Placebo Then Telcagepant|Participants receive single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 1 and a single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
829504|NCT01294709|P1|Participant Flow|Telcagepant Then Placebo|Participants receive single oral dose of 600 mg (two 300 mg capsules or two bioequivalent 280 mg tablets) or 900 mg telcagepant (three 300 mg capsules) in Period 1 and single oral dose of two capsules or tablets of placebo for telcagepant (or three capsules of placebo for telcagepant) in Period 2 of the crossover. Each treatment period is separated by a washout of 96-240 hours.
829505|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
829506|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
829507|NCT01294709|O2|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
829508|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
829509|NCT01294709|O2|Outcome|Placebo|Participants who received single oral dose of placebo in Period 1 or 2 of crossover
829510|NCT01294709|O1|Outcome|Telcagepant|Participants who received a single oral dose of 600 mg (or bioequivalent 560 mg tablets) or 900 mg telcagepant in Period 1 or 2 of crossover
829511|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
829512|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
829513|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
829514|NCT01294709|O3|Outcome|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
829515|NCT01294709|O2|Outcome|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
829516|NCT01294709|O1|Outcome|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
829517|NCT01294709|E3|Reported Event|Placebo|Participants who received a single oral dose of placebo in Period 1 or 2 of crossover
829518|NCT01294709|E2|Reported Event|Telcagepant (900 mg)|Participants who received a single oral dose of 900 mg telcagepant in Period 1 or 2 of crossover
829555|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829519|NCT01294709|E1|Reported Event|Telcagepant (600 mg)|Participants who received a single oral dose of 600 mg telcagepant capsules (or 560 mg of bioequivalent tablets) in Period 1 or 2 of crossover
829520|NCT01294696|B3|Baseline|Total|Total of all reporting groups
829521|NCT01294696|B2|Baseline|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
829522|NCT01294696|B1|Baseline|Participants With Adequate Pain Relief|Adequate pain relief was defined as an average pain score of <=4 on the Brief Pain Inventory (BPI). Baseline characteristics are only reported for participants with data available at baseline.
829523|NCT01294696|P1|Participant Flow|All Enrolled Participants|The population consisted of all enrolled participants with adequate and inadequate pain relief.
829524|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829525|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829526|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829527|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829528|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829529|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829530|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829531|NCT01294696|O1|Outcome|All Enrolled Participants|All enrolled participants that were treated with the local standard of care for osteoarthritis of the knee.
829532|NCT01294696|E2|Reported Event|Participants With Inadequate Pain Relief|Inadequate pain relief was defined as an average pain score of >4 on the BPI. Baseline characteristics are only reported for participants with data available at baseline.
829533|NCT01294696|E1|Reported Event|Participants With Adequate Pain Relief|Adequate pain relief was fedined as an average pain score of <=4 on the Brief Pain Inventory (BPI).
829534|NCT01294683|B3|Baseline|Total|Total of all reporting groups
829535|NCT01294683|B2|Baseline|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
829536|NCT01294683|B1|Baseline|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
829579|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
829537|NCT01294683|P2|Participant Flow|Sequence 2: MK-0524A 2g + Simvastatin 40 mg→ MK-0524B 2g/40g|After a 2-week placebo run-in, participants received ERN/LRPT 1 g (MK-0524A) co-administered with SIM 20 mg once daily for 4 weeks then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks. Participants then received ERN/LRPT/SIM 2 g/40 mg combination tablets (MK-0524B) once daily for 8 weeks.
829538|NCT01294683|P1|Participant Flow|Sequence 1: MK-0524B 2g/40g→MK-0524A 2g + Simvastatin 40 mg|After a 2-week placebo run-in, participants received extended release niacin/laropiprant (ERN/LRPT) 1 g/20 mg combination tablet (MK-0524B) once daily for 4 weeks, then ERN/LRPT/Simvastatin (SIM) 2 g/40 mg combination tablet once daily for 8 weeks. Participants then received ERN/LRPT 2 g (MK-0524A) co-administered with SIM 40 mg once daily for 8 weeks.
829539|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829540|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829541|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829542|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829543|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829544|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829545|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829546|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829547|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829548|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829549|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829550|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829551|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829552|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829553|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829669|NCT01294462|P2|Participant Flow|Clopidogrel|Clopidogrel 75mg od
829556|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829557|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829558|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829559|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829560|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829561|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829562|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829563|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829564|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829565|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829566|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829567|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829568|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829569|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829570|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829571|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829572|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829573|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829574|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829575|NCT01294683|O4|Outcome|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829576|NCT01294683|O3|Outcome|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III.
829577|NCT01294683|O2|Outcome|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
829578|NCT01294683|O1|Outcome|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829580|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
829581|NCT01294683|O2|Outcome|MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
829582|NCT01294683|O1|Outcome|MK-0524B 2g/40mg|Participants who received MK-0524B 2g/40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
829583|NCT01294683|E4|Reported Event|Sequence 2: MK-0524B 2g/40g|Participants who received MK-0524B 2g/40mg during Period III
829584|NCT01294683|E3|Reported Event|Sequence 1: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 2g+ Simvastatin 40mg during Period III
829585|NCT01294683|E2|Reported Event|Sequence 2: MK-0524A 2g + Simvastatin 40 mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
829586|NCT01294683|E1|Reported Event|Sequence 1: MK-0524B 2g/40g|Participants who received MK-0524B 1g/40mg and MK-0524B 2g/40mg during Periods I/II
829587|NCT01294644|B4|Baseline|Total|Total of all reporting groups
829588|NCT01294644|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829589|NCT01294644|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829590|NCT01294644|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829591|NCT01294644|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829592|NCT01294644|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829593|NCT01294644|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829594|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829595|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829596|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829597|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829598|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829599|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829600|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829601|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829602|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829603|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829604|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829605|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829606|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829607|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829608|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829609|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829610|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829611|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829612|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829613|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829614|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829615|NCT01294644|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829616|NCT01294644|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829617|NCT01294644|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829618|NCT01294644|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829619|NCT01294644|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments
829620|NCT01294644|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
829621|NCT01294592|B3|Baseline|Total|Total of all reporting groups
829622|NCT01294592|B2|Baseline|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829623|NCT01294592|B1|Baseline|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829670|NCT01294462|P1|Participant Flow|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
829671|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
829672|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
829673|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
829674|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
829624|NCT01294592|P2|Participant Flow|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829625|NCT01294592|P1|Participant Flow|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829626|NCT01294592|O3|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
829627|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829628|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829629|NCT01294592|O2|Outcome|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
829630|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829631|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829632|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829633|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829634|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829705|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829706|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829635|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829636|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829637|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829638|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829639|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829640|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829641|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829642|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829675|NCT01294462|O2|Outcome|Clopidogrel|Clopidogrel 75mg od
829676|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
829643|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829644|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829645|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829646|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829647|NCT01294592|O2|Outcome|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study. If participants did not receive tamsulosin, they were not classified as escalated (Watchful Waiting Escalated=No).
829648|NCT01294592|O1|Outcome|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829649|NCT01294592|E3|Reported Event|Watchful Waiting Escalated=Yes|All participants were given lifestyle advice. If any IPSS was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
829650|NCT01294592|E2|Reported Event|Watchful Waiting All: Escalated Yes and No|All participants were given lifestyle advice. If any International Prostate Symptom Score (IPSS) was the same or greater than the Baseline value at any study visit (post-randomization), participants received tamsulosin 0.4 mg once daily (Watchful Waiting Escalated=Yes). Tamsulosin was continued until the end of the study unless the participant elected to withdraw from the study.
829651|NCT01294592|E1|Reported Event|Dutasteride Plus Tamsulosin|Participants received a combination of dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg plus lifestyle advice for 24 months.
829652|NCT01294553|B1|Baseline|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
829653|NCT01294553|P1|Participant Flow|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to the appropriate dose of Avandamet tablet based on their current regimen (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg). Participants were not to have exceeded the maximum recommended daily dose of 8/2000. All participants were to have started the rosiglitazone component of Avandamet at the lowest recommended dose, and all dose increases should have been accompanied by careful monitoring for adverse events related to fluid retention.
829707|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829654|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
829655|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 mg, 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
829656|NCT01294553|O1|Outcome|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
829657|NCT01294553|E1|Reported Event|Avandamet 1/500, 2/500, 4/500, 2/1000, or 4/1000 mg|Participants were assigned to appropriate dose of Avandamet tablet (fixed dose combination of rosiglitazone and metformin, 1/500 milligrams [mg], 2/500 mg, 4/500 mg, 2/1000 mg, or 4/1000 mg) per physician's decision based on participant's condition
829658|NCT01294514|B1|Baseline|Healthy Volunteers|Healthy volunteers were studied
829659|NCT01294514|P1|Participant Flow|Respiration Rate in Healthy Volunteers|"Healthy volunteer participants were monitored for 30 minute period to collect respiratory rate information from non-invasive sensors.~Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide."
829660|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide.
829661|NCT01294514|O1|Outcome|Healthy Volunteers|Covidien Respiration Rate, Transthoracic Impedance and Overscored Endtidal Carbon Dioxide derived respiration rates were recorded on all the volunteers simultaneously.
829662|NCT01294514|O3|Outcome|Respiration Rate From Transthoracic Impedance|Respiration Rate determined by Transthoracic Impedance
829663|NCT01294514|O2|Outcome|Respiration Rate From Endtidal Carbon Dioxide|Respiration Rate determined by manual overscoring of capnography waveforms.
829664|NCT01294514|O1|Outcome|Respiration Rate From Covidien Respiration Rate Software|Respiration Rate determined by novel plethysmographic analysis
829665|NCT01294514|E1|Reported Event|Healthy Volunteers|A selection of subjects from the general population from ages 18 - 50.
829666|NCT01294462|B3|Baseline|Total|Total of all reporting groups
829667|NCT01294462|B2|Baseline|Clopidogrel|Clopidogrel 75mg od
829668|NCT01294462|B1|Baseline|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90 mg bid
829678|NCT01294462|O1|Outcome|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
829679|NCT01294462|E2|Reported Event|Clopidogrel|Clopidogrel 75mg od
829680|NCT01294462|E1|Reported Event|Ticagrelor (AZD6140)|Ticagrelor (AZD6140) 90mg bid
829681|NCT01294449|B3|Baseline|Total|Total of all reporting groups
829682|NCT01294449|B2|Baseline|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
829683|NCT01294449|B1|Baseline|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
829684|NCT01294449|P2|Participant Flow|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
829685|NCT01294449|P1|Participant Flow|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
829686|NCT01294449|O2|Outcome|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
829687|NCT01294449|O1|Outcome|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
829688|NCT01294449|E2|Reported Event|MADIT-CRT CRT-D|MADIT-CRT CRT-D: Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
829689|NCT01294449|E1|Reported Event|MADIT-CRT ICD|MADIT-CRT ICD: Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
829690|NCT01294436|B3|Baseline|Total|Total of all reporting groups
829691|NCT01294436|B2|Baseline|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829692|NCT01294436|B1|Baseline|Monotherapy|Dapagliflozin 5/10 mg only
829693|NCT01294436|P2|Participant Flow|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829694|NCT01294436|P1|Participant Flow|Monotherapy|Dapagliflozin 5/10 mg only
829695|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829696|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829697|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829698|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829699|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829700|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829701|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829702|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829703|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829704|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829709|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829710|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829711|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829712|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829713|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829714|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829715|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829716|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829717|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829718|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829719|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829720|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829721|NCT01294436|O2|Outcome|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829722|NCT01294436|O1|Outcome|Monotherapy|Dapagliflozin 5/10 mg only
829723|NCT01294436|E2|Reported Event|All Combination Therapies|Dapagliflozin 5/10 mg in combination with any anti-diabetic drugs
829724|NCT01294436|E1|Reported Event|Monotherapy|Dapagliflozin 5/10 mg only
829725|NCT01294423|B4|Baseline|Total|Total of all reporting groups
829726|NCT01294423|B3|Baseline|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
829727|NCT01294423|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
829728|NCT01294423|B1|Baseline|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
829729|NCT01294423|P3|Participant Flow|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
829730|NCT01294423|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
829731|NCT01294423|P1|Participant Flow|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
829732|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
829733|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
829734|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
829735|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
829736|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
829737|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
829738|NCT01294423|O3|Outcome|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
829739|NCT01294423|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
829740|NCT01294423|O1|Outcome|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
829741|NCT01294423|E3|Reported Event|Placebo|Placebo : Matching placebo for Dapagliflozin 5mg/10mg oral dose
829742|NCT01294423|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin : Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
829743|NCT01294423|E1|Reported Event|Dapagliflozin 5 mg|Dapagliflozin : Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
829744|NCT01294384|B4|Baseline|Total|Total of all reporting groups
829745|NCT01294384|B3|Baseline|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829746|NCT01294384|B2|Baseline|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829747|NCT01294384|B1|Baseline|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829748|NCT01294384|P3|Participant Flow|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829749|NCT01294384|P2|Participant Flow|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829750|NCT01294384|P1|Participant Flow|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829751|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829752|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829753|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829754|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829755|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829756|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829757|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829758|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829759|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829760|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829761|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829762|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829763|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829764|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829765|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829766|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829767|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829768|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829769|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829770|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829771|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829772|NCT01294384|O3|Outcome|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829773|NCT01294384|O2|Outcome|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829774|NCT01294384|O1|Outcome|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829775|NCT01294384|E3|Reported Event|Refresh Tears®|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
829776|NCT01294384|E2|Reported Event|New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
829777|NCT01294384|E1|Reported Event|New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
829804|NCT01294228|P1|Participant Flow|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
829778|NCT01294371|B1|Baseline|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
829779|NCT01294371|P1|Participant Flow|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
829780|NCT01294371|O3|Outcome|No Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and no add-back therapy.
829781|NCT01294371|O2|Outcome|Plus Add-Back Therapy|Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions, and add-back therapy following local guidelines or therapeutic recommendations.
829782|NCT01294371|O1|Outcome|Overall|"Participants with genital endometriosis received leuprorelin in accordance with the respective Marketing Authorization/ Manufacturer's directions for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was impossible — phytoestrogens with calcium products."
829783|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
829826|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
829855|NCT01293825|B1|Baseline|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829784|NCT01294371|O1|Outcome|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
829785|NCT01294371|E1|Reported Event|Leuprorelin|"Patients with genital endometriosis received leuprorelin (Lucrin Depot®) in accordance with the respective marketing authorization/manufacturer's directions. All participants received leuprorelin for up to 6 months intramuscularly at a dose of 3.75 mg once a month. If intramuscular administration was not possible, leuprorelin was injected subcutaneously at a dose of 3.75 mg once a month. The first injection was to be carried out on the 3rd day of a menstrual period.~Accepted options for add-back therapy included: monophasic combined low-dose products for hormonal replacement therapy; combined oral contraceptives; and, if use of hormones was not possible, phytoestrogens with calcium products."
829786|NCT01294306|B3|Baseline|Total|Total of all reporting groups
829787|NCT01294306|B2|Baseline|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829788|NCT01294306|B1|Baseline|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829789|NCT01294306|P2|Participant Flow|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829790|NCT01294306|P1|Participant Flow|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829791|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829792|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829793|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829794|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829795|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829796|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829797|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829798|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829799|NCT01294306|O2|Outcome|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829800|NCT01294306|O1|Outcome|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829801|NCT01294306|E2|Reported Event|EGFR Wild-Type Tumors|Patients with EGFR wild-type tumors.
829802|NCT01294306|E1|Reported Event|EGFR-Mutated Tumors|Patients with EGFR-mutated tumors.
829803|NCT01294228|B1|Baseline|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
829805|NCT01294228|O1|Outcome|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
829806|NCT01294228|E1|Reported Event|Clinical Study Population|All study participants underwent the same study procedures and their clinical data was analyzed as a homogenous population.
829807|NCT01294163|B4|Baseline|Total|Total of all reporting groups
829808|NCT01294163|B3|Baseline|TIVA|Anesthetic agent before and after CPB: propofol
829809|NCT01294163|B2|Baseline|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
829810|NCT01294163|B1|Baseline|Xenon|Anesthetic agent before and after CPB: xenon
829811|NCT01294163|P3|Participant Flow|TIVA|Anesthetic agent before and after CPB: propofol
829812|NCT01294163|P2|Participant Flow|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
829813|NCT01294163|P1|Participant Flow|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
829814|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
829815|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
829816|NCT01294163|O2|Outcome|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
829817|NCT01294163|O1|Outcome|Xenon|Anesthetic agent before and after CPB: xenon
829818|NCT01294163|E3|Reported Event|TIVA|Anesthetic agent before and after CPB: propofol
829819|NCT01294163|E2|Reported Event|Sevoflurane|Anesthetic agent before and after CPB: sevoflurane
829820|NCT01294163|E1|Reported Event|Xenon Including Pilot Patients|Anesthetic agent before and after CPB: xenon
829821|NCT01294150|B3|Baseline|Total|Total of all reporting groups
829822|NCT01294150|B2|Baseline|Cystoscopy|Sham treatment entailed rigid cystoscopy, a blinding screen and sounds that mimicked those of the prostatic urethral lift procedure.
829823|NCT01294150|B1|Baseline|UroLift System|Average of 4.9 implants per prostate implanted. The prostatic urethral lift is performed by placing permanent transprostatic implants to lift apart the prostate lobes and reduce urethral obstruction.
829824|NCT01294150|P2|Participant Flow|Cystoscopy (Control/Sham)|The control group subjects underwent a cystoscopy procedure. The subject was blinded as to whether he was randomized to the control or treatment group. Unblinding occurred at 3 months post procedure after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo procedure with the UroLift system, provided he met the inclusion and exclusion criteria. Subjects crossing over are then to be followed for 5 years post-treatment. If subject did not crossover, his participation was not required beyond the 12 month visit.
829825|NCT01294150|P1|Participant Flow|UroLift System|The treatment group subjects underwent the UroLift (UL)system procedure. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to be retreated with the UroLift system if he met the retreatment inclusion and exclusion criteria. Subjects that went on to UL retreatment within the first 12 months were considered treatment failures, but started their follow-up schedule over. All subjects will be followed at a minimum of 5 years per the assessment schedule.
829827|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
829828|NCT01294150|O2|Outcome|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
829829|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
829830|NCT01294150|O1|Outcome|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. No matter which retreatment therapy, all subjects will be followed at a minimum of 5 years per the assessment schedule.
829831|NCT01294150|E2|Reported Event|Cystoscopy|The control group subjects underwent a cystoscopy procedure only. The subject was blinded as to whether he was in the control or treatment group. Unblinding occurred at 3 months after follow-up assessments were completed. Between 3 and 12 month follow-up assessments, a subject was allowed to crossover and undergo the UroLift system procedure if he met inclusion and exclusion criteria. Subjects who crossed over will then be followed for 5 years post-treatment. The subjects that did not crossover were not required to participate beyond 12 months.
829832|NCT01294150|E1|Reported Event|UroLift System|The treatment group subjects underwent UroLift system procedure. The subject was blinded to the randomization of control or treatment group. Unblinding occurred at 3 months post procedure after the assessments were completed. All subjects will be followed at a minimum of 5 years per the assessment schedule.
829833|NCT01294046|B1|Baseline|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
829834|NCT01294046|P1|Participant Flow|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
829835|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
829869|NCT01293695|B1|Baseline|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy (HRT)~Hypnosis: Hypnosis relaxation in five weekly sessions"
829836|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
829837|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
829838|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
829839|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No data were collected from this entire study, so no data were analyzed."
829840|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
829841|NCT01294046|O1|Outcome|Deep Brain Stimulation of SPG for Migraine|"Electrical SPG for Treatment of Migraine~Deep Brain Stimulation of SPG for Migraine: Deep Brain Stimulation of SPG for Migraine~No outcome measure data was analyzed because no outcome data were collected."
829842|NCT01294046|O1|Outcome|Experimental: Deep Brain Stimulation Arm Group|"Experimental: Deep brain stimulation arm group~Electrical Stimulation of SPG for Treatment of Migraine"
829843|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
829844|NCT01294046|O1|Outcome|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
829845|NCT01294046|E1|Reported Event|Deep Brain Stimulation Arm Group|"Electrical Stimulation of SPG for Treatment of Migraine~Electrical Stimulation of SPG for Treatment of Migraine: Electrical Stimulation of the Sphenopalatine Ganglion for the Treatment of Migraine Headaches"
829846|NCT01293968|B3|Baseline|Total|Total of all reporting groups
829847|NCT01293968|B2|Baseline|Diphenhydramine and Aluminium MgS|
829848|NCT01293968|B1|Baseline|Ibuprofen, Diphenhydramine and Aluminium MgS|
829849|NCT01293968|P2|Participant Flow|Diphenhydramine and Aluminium MgS|
829850|NCT01293968|P1|Participant Flow|Ibuprofen, Diphenhydramine and Aluminium MgS|
829851|NCT01293968|O2|Outcome|Diphenhydramine and Aluminium MgS|the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
829852|NCT01293968|O1|Outcome|Ibuprofen, Diphenhydramine and Aluminium MgS|the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
829853|NCT01293968|E2|Reported Event|Diphenhydramine and Aluminium MgS|
829854|NCT01293968|E1|Reported Event|Ibuprofen, Diphenhydramine and Aluminium MgS|
829936|NCT01293006|O2|Outcome|Placebo|Participants receiving placebo.
829856|NCT01293825|P1|Participant Flow|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829857|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829858|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829859|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829860|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829861|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829862|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829863|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829864|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829865|NCT01293825|O1|Outcome|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829866|NCT01293825|E1|Reported Event|Medication Adherence Bipolar Disorder|"Drug: Ziprasidone. Dosages were titrated for each participant up to a maximum of 160 mg/day from a minimum of 20 mg/day. Dosages were in pill form once per day.~There was only one group for this study."
829867|NCT01293695|B3|Baseline|Total|Total of all reporting groups
829868|NCT01293695|B2|Baseline|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829870|NCT01293695|P2|Participant Flow|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829871|NCT01293695|P1|Participant Flow|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
829872|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829873|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
829874|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829875|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions."
829876|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829877|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions."
829878|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829879|NCT01293695|O1|Outcome|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
829880|NCT01293695|O2|Outcome|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829881|NCT01293695|O1|Outcome|Hypnosis|"Received 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions. Weekly hot flash scores were averaged."
829882|NCT01293695|E2|Reported Event|Structured Attention|"Meets with therapist for five weekly sessions, but receives no hypnotic relaxation therapy~Structured Attention: Meets for five weekly sessions for discussion on hot flashes; no hypnosis"
829883|NCT01293695|E1|Reported Event|Hypnosis|"Receives 5 weeks of hypnotic relaxation therapy~Hypnosis: Hypnosis relaxation in five weekly sessions"
829884|NCT01293240|B1|Baseline|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829885|NCT01293240|P1|Participant Flow|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829886|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829887|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829888|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829889|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829890|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829891|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829892|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829893|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829894|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829895|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829896|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829897|NCT01293240|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829898|NCT01293240|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel contact lenses worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
829899|NCT01293084|B1|Baseline|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
829900|NCT01293084|P1|Participant Flow|Children With CF|Children with CF inhaled either 5 mL of 7% saline or 0.12% saline once over 20 minutes. On a second visit, the same children were crossed-over and inhaled either 0.12% saline or 7% saline over 20 minutes. The order of these visits was randomized but the sequence of the randomization is not known.
829901|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
829902|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
829903|NCT01293084|O2|Outcome|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
829904|NCT01293084|O1|Outcome|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
829905|NCT01293084|E2|Reported Event|0.12% Saline|"5mL 0.12% saline inhaled once during 20 minutes~0.12% saline: 5mL of 0.12% saline inhaled once over 20 minutes"
829906|NCT01293084|E1|Reported Event|7% Saline|"5 mL of 7% saline was inhaled once over a 20 minute period.~7% saline: 5mL 7% saline inhaled once over 20 minutes"
829907|NCT01293032|B5|Baseline|Total|Total of all reporting groups
829908|NCT01293032|B4|Baseline|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
829909|NCT01293032|B3|Baseline|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
829910|NCT01293032|B2|Baseline|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
829911|NCT01293032|B1|Baseline|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
829912|NCT01293032|P4|Participant Flow|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
829913|NCT01293032|P3|Participant Flow|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
829937|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants receiving either a 40-mg or 30-mg dose of suvorexant.
829938|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
829914|NCT01293032|P2|Participant Flow|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
829915|NCT01293032|P1|Participant Flow|Group 1 (RS < 11)|"Patients with a RS of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
829916|NCT01293032|O1|Outcome|Group 2 (RS 11-25)|Patients with an intermediate RS (11-25) were assigned to Group 2. The subject was then randomized to treatment Arm 1, neoadjuvant hormonal therapy, or treatment Arm 2, neoadjuvant chemotherapy.
829917|NCT01293032|E4|Reported Event|Group 3 (RS > 25)|"Patients with a high RS (> 25) were assigned to Group 3. They received chemotherapy, neoadjuvant chemotherapy as in Group 2 Arm 2.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
829918|NCT01293032|E3|Reported Event|Group 2 Arm 2 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 2 they received 6-8 courses of neoadjuvant chemotherapy comprised of anthracycline/taxane based regimen over 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/Oncotype DX Gene Expression Profiling System~Systemic chemotherapy"
829919|NCT01293032|E2|Reported Event|Group 2 Arm 1 (RS 11-25)|"Patients with an intermediate RS (11-25) were assigned to Group 2. If randomized to Arm 1 they received neoadjuvant hormonal therapy as in Group 1.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
829920|NCT01293032|E1|Reported Event|Group 1 (RS < 11)|"Patients with a Recurrence Score (RS) of less than 11 were assigned to Group 1. They received neoadjuvant hormonal therapy comprised of tamoxifen (pre-menopausal women) or an aromatase inhibitor (post-menopausal women) for 4-6 months in the absence of disease progression or unacceptable toxicity.~Treatment:~Neoadjuvant therapy~Therapeutic conventional surgery~Laboratory biomarker analysis/Correlative studies~Gene Expression Analysis/ Oncotype DX Gene Expression Profiling System~Hormonal therapy:~Tamoxifen Citrate (pre-menopausal women) OR~Aromatase Inhibition Therapy (post-menopausal women)"
829921|NCT01293006|B5|Baseline|Total|Total of all reporting groups
830061|NCT01292486|B1|Baseline|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
829922|NCT01293006|B4|Baseline|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
829923|NCT01293006|B3|Baseline|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
829924|NCT01293006|B2|Baseline|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of MK-suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
829925|NCT01293006|B1|Baseline|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of, at least, 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
829926|NCT01293006|P4|Participant Flow|Placebo Then Suvorexant (30 mg)|During Period 1, participants ≥65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
829927|NCT01293006|P3|Participant Flow|Placebo Then Suvorexant (40 mg)|During Period 1, participants <65 years of age received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening.
829928|NCT01293006|P2|Participant Flow|Suvorexant (30 mg) Then Placebo|During Period 1, participants ≥65 years of age were administered a 30-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
829929|NCT01293006|P1|Participant Flow|Suvorexant (40 mg) Then Placebo|During Period 1, participants <65 years of age were administered a 40-mg oral dose of suvorexant once daily for 4 consecutive days in the evening. A washout period of at least 7 days followed Period 1. During Period 2, participants received one placebo tablet matching suvorexant, orally, once daily for 4 consecutive days in the evening.
829930|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
829931|NCT01293006|O1|Outcome|Suvorexant (40 mg or 30 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
829932|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
829933|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg dose of suvorexant.
829934|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
829935|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or 30-mg dose of suvorexant.
829939|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
829940|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
829941|NCT01293006|O3|Outcome|Placebo|Participants administered placebo.
829942|NCT01293006|O2|Outcome|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
829943|NCT01293006|O1|Outcome|Suvorexant (40 mg)|Participants administered a 40-mg oral dose of suvorexant.
829944|NCT01293006|O2|Outcome|Placebo|Participants administered placebo.
829945|NCT01293006|O1|Outcome|Suvorexant (30 mg or 40 mg)|Participants administered either a 40-mg or a 30-mg oral dose of suvorexant.
829946|NCT01293006|E3|Reported Event|Placebo|Participants administered placebo.
829947|NCT01293006|E2|Reported Event|Suvorexant (30 mg)|Participants administered a 30-mg oral dose of suvorexant.
829948|NCT01293006|E1|Reported Event|Suvorexant (40 mg)|Participants administered a 40-mg dose of suvorexant.
829949|NCT01292928|B1|Baseline|Innova Stent|Stent implantation into SFA/PPA
829950|NCT01292928|P1|Participant Flow|Innova Stent|Stent implantation into Superficial Femoral Artery (SFA) / Proximal Popliteal Artery (PPA)
829951|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829952|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829953|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829954|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829955|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829956|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829957|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829958|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829959|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829960|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829961|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829962|NCT01292928|O2|Outcome|Innova Stent Entire Matrix (20-200 mm)|Entire Matrix Stent implantation into SFA/PPA
829963|NCT01292928|O1|Outcome|Innova Stent Core Matrix (20-150 mm)|Core Matrix Stent implantation into SFA/PPA
829964|NCT01292928|O1|Outcome|Innova Stent|Stent implantation into SFA/PPA
829965|NCT01292928|E1|Reported Event|Innova Stent|Stent implantation into SFA/PPA
829966|NCT01292837|B1|Baseline|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
830125|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
829967|NCT01292837|P1|Participant Flow|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829968|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829969|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829970|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829971|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829972|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829973|NCT01292837|O1|Outcome|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829974|NCT01292837|E1|Reported Event|Levetiracetam|"Twice daily (morning and evening) orally~Levetiracetam: The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks."
829975|NCT01292798|B1|Baseline|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
829976|NCT01292798|P1|Participant Flow|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
829977|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
829978|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
829979|NCT01292798|O1|Outcome|0.5mg and 2.0mgRanibizumab|"Three consecutive intravitreal ranibizumab 0.5mg injections followed by three consecutive intravitreal ranibizumab 2.0mg injections if specific criteria is met.~Ranibizumab: 0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally"
830107|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
829980|NCT01292798|E1|Reported Event|2.0 mg Ranibizumab|Subjects who presented with persistent DME at month 3 following 3 months of monthly 0.5 mg ranibizumab injections received 3 monthly injections of 2.0 mg Ranibizumab.
829981|NCT01292746|B1|Baseline|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
829982|NCT01292746|P1|Participant Flow|Erchonia MLS|Erchonia MLS employs four diodes emitting 10 milliwatts (mW) 635 nanometer (nm) red laser light.
829983|NCT01292746|O1|Outcome|Erchonia MLS|Erchonia MLS: The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
829984|NCT01292746|E1|Reported Event|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
829985|NCT01292642|B1|Baseline|Treatment|CBT plus NRT
829986|NCT01292642|P1|Participant Flow|Treatment|Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
829987|NCT01292642|O1|Outcome|Treatment|CBT plus NRT
829988|NCT01292642|O2|Outcome|Post Treatment - Cannabis Inhalations Per Day|
829989|NCT01292642|O1|Outcome|Baseline - Cannabis Inhalations Per Day|CBT plus NRT
829990|NCT01292642|O2|Outcome|PostTreatment - Cigarettes Per Day|CBT plus NRT
829991|NCT01292642|O1|Outcome|Baseline - Cigarettes Per Day|
829992|NCT01292642|E1|Reported Event|Treatment|CBT plus NRT
829993|NCT01292629|B1|Baseline|iSert® 251 Intraocular Lens|Population Description: A total of 125 subjects were implanted with the iSert® IOL. Data analysis for baseline characteristics was completed on these 125 subjects.
829994|NCT01292629|P1|Participant Flow|iSert 251: iSert 251 Intraocular Lens|Implantation with the iSert® 251 Intraocular lens
829995|NCT01292629|O1|Outcome|iSert 251 Aphakik IOL|iSert 251: iSert 251 intraocular lens
829996|NCT01292629|O1|Outcome|iSert 251: iSert 251 Intraocular Lens|Eligible subjects underwent phacoemulsification cataract extraction surgery and were implanted with the iSert® Intraocular Lens. Study observation was up to 271 days.
829997|NCT01292629|E1|Reported Event|iSert 251: iSert 251 Intraocular Lens|Subjects who underwent phacoemulsification cataract extraction surgery who were implanted with the iSert aphakic intraocular lens.
829998|NCT01292603|B6|Baseline|Total|Total of all reporting groups
830216|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
829999|NCT01292603|B5|Baseline|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830000|NCT01292603|B4|Baseline|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830001|NCT01292603|B3|Baseline|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830002|NCT01292603|B2|Baseline|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830003|NCT01292603|B1|Baseline|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830004|NCT01292603|P6|Participant Flow|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830005|NCT01292603|P5|Participant Flow|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830006|NCT01292603|P4|Participant Flow|No SC Dose Received|These participants were withdrawn prior to SC treatment.
830034|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830007|NCT01292603|P3|Participant Flow|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830008|NCT01292603|P2|Participant Flow|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830009|NCT01292603|P1|Participant Flow|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 milligrams per square meter (mg/m^2) on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830010|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830011|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830217|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830012|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830013|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830014|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
830015|NCT01292603|O4|Outcome|Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830016|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830017|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830018|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830019|NCT01292603|O5|Outcome|No SC Dose Received|These participants were withdrawn prior to SC treatment.
830020|NCT01292603|O4|Outcome|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830097|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
830098|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830099|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
830021|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830022|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830023|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 Milligrams (mg)|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830024|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830025|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830355|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830026|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830027|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830028|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830029|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830030|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830031|NCT01292603|O3|Outcome|Part 1: Rituximab SC 1870 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830032|NCT01292603|O2|Outcome|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830033|NCT01292603|O1|Outcome|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with fludarabine/cyclophosphamide (FC) prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830100|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
830101|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
830102|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830035|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830036|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830037|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830038|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830039|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830040|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830218|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
830041|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830042|NCT01292603|O2|Outcome|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830043|NCT01292603|O1|Outcome|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830044|NCT01292603|O1|Outcome|Part 1: Rituximab SC|"Participant could have been enrolled any time during their treatment with rituximab IV in combination with FC prior to Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400, 1600 or 1870 mg on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830045|NCT01292603|E7|Reported Event|Part 2: Rituximab SC 1600 mg|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: SC rituximab 1600 mg on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830046|NCT01292603|E6|Reported Event|Part 2 : Rituximab IV 500 mg/m^2|"Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 0~Cycles 2-6: IV rituximab 500 mg/m^2 on Day 1~Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830047|NCT01292603|E5|Reported Event|No SC Dose Received|These participants were withdrawn prior to SC treatment.
830048|NCT01292603|E4|Reported Event|Part 1: Rituximab SC 1000 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1000 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830049|NCT01292603|E3|Reported Event|Part 1: Rituximab SC 1870 mg|"PParticipant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1870 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830103|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
830104|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
830105|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
830106|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830050|NCT01292603|E2|Reported Event|Part 1: Rituximab SC 1600 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1600 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830051|NCT01292603|E1|Reported Event|Part 1: Rituximab SC 1400 mg|"Participant could have been enrolled any time during treatment with rituximab IV in combination with FC before Cycle 5. Participants received the following in 28-day cycles.~Cycle 1: IV rituximab 375 mg/m^2 on Day 1 or Day 0 (according to local practice) Cycles 2-5: IV rituximab 500 mg/m^2 on Day 1 Cycle 6: SC rituximab 1400 on Day 1 Cycles 1-6: IV fludarabine 25 mg/m^2 on Days 1−3 (or as an oral dose of 24 mg/m^2 on Days 1-5 or 30-40 mg/m^2 on Days 1-3), and IV cyclophosphamide 250 mg/m^2 on Days 1−3 (or as an oral dose of 150 mg/m^2 on Days 1−5 or 200-250 mg/m^2 on Days 1−3)."
830052|NCT01292538|B3|Baseline|Total|Total of all reporting groups
830053|NCT01292538|B2|Baseline|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
830054|NCT01292538|B1|Baseline|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
830055|NCT01292538|P2|Participant Flow|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
830056|NCT01292538|P1|Participant Flow|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
830057|NCT01292538|O2|Outcome|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
830058|NCT01292538|O1|Outcome|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
830059|NCT01292538|E2|Reported Event|Placebo Laser|"Sham light output with no therapeutic benefit~Placebo laser: Sham light output with no therapeutic benefit"
830060|NCT01292538|E1|Reported Event|Erchonia GLS 532nm|"532nm green laser light therapy.~Erchonia GLS: 532 nm green diode low level laser light device"
830062|NCT01292486|P1|Participant Flow|All Per Protocol Patients|This was a single arm study, which evaluated Multiple Myeloma patients who received autologous stem-cell transplants collected using the Spectra Optia Apheresis System, following myeloablative therapy. The study was limited to subjects who were expected to demonstrate normal neutrophil recovery.
830063|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
830064|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
830065|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
830066|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
830067|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
830068|NCT01292486|O1|Outcome|All Per Protocol Patients|Multiple myeloma patients infused with autologous peripheral blood stem cells collected on the Spectra Optia Apheresis System.
830069|NCT01292486|O1|Outcome|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
830070|NCT01292486|E1|Reported Event|Patients With Multiple Myeloma|Multiple myeloma patients requiring myeloablative therapy and a first autologous hematopoetic stem cell transplant.
830071|NCT01292473|B5|Baseline|Total|Total of all reporting groups
830072|NCT01292473|B4|Baseline|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
830073|NCT01292473|B3|Baseline|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
830074|NCT01292473|B2|Baseline|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
830075|NCT01292473|B1|Baseline|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
830076|NCT01292473|P4|Participant Flow|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
830077|NCT01292473|P3|Participant Flow|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
830078|NCT01292473|P2|Participant Flow|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
830079|NCT01292473|P1|Participant Flow|Placebo|Placebo subcutaneously (sc) every 4 weeks.
830080|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
830081|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
830082|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830083|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
830084|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
830085|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
830086|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830087|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
830088|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
830089|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
830090|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830091|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
830092|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
830093|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks
830094|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830095|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
830096|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks
830108|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
830109|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
830110|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
830111|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
830112|NCT01292473|O4|Outcome|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
830113|NCT01292473|O3|Outcome|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
830114|NCT01292473|O2|Outcome|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks
830115|NCT01292473|O1|Outcome|Placebo|Placebo administered subcutaneously (sc) every 4 weeks
830116|NCT01292473|E4|Reported Event|Omalizumab 300 mg|Omalizumab 300 mg sc every 4 weeks.
830117|NCT01292473|E3|Reported Event|Omalizumab 150 mg|Omalizumab 150 mg sc every 4 weeks.
830118|NCT01292473|E2|Reported Event|Omalizumab 75 mg|Omalizumab 75 mg sc every 4 weeks.
830119|NCT01292473|E1|Reported Event|Placebo|Placebo administered subcutaneously (sc) every 4 weeks.
830120|NCT01292304|B1|Baseline|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
830121|NCT01292304|P1|Participant Flow|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
830122|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
830123|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
830124|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
830219|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830126|NCT01292304|O1|Outcome|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
830127|NCT01292304|E1|Reported Event|Tolvaptan|"Tolvaptan 15 mg tablet once daily for 7 days followed by Tolvaptan 30 mg (two 15 mg tablets) once daily according to efficacy and tolerability~Tolvaptan: Oral administration once daily Dosage will range from 15 mg to 30 mg"
830128|NCT01292265|B1|Baseline|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
830129|NCT01292265|P1|Participant Flow|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
830130|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
830131|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
830132|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
830133|NCT01292265|O1|Outcome|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
830134|NCT01292265|E1|Reported Event|CZP 200 mg|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
830135|NCT01292239|B3|Baseline|Total|Total of all reporting groups
830136|NCT01292239|B2|Baseline|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830137|NCT01292239|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830138|NCT01292239|P2|Participant Flow|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830139|NCT01292239|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830140|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830141|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830142|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830143|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830144|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830145|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830146|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830147|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830148|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830220|NCT01292135|E2|Reported Event|PCI-32765 Plus Fludarabine/ Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
830149|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830150|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830151|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830152|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830153|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830154|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830155|NCT01292239|O2|Outcome|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830156|NCT01292239|O1|Outcome|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830157|NCT01292239|E2|Reported Event|PBO 12 Wks + PR 48|Participants were given placebo (PBO) once daily plus peginterferon alfa-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 48 (PR 48).
830158|NCT01292239|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants were given TMC435 100 mg once daily plus peginterferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFNα-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved plasma levels of Hepatitis C virus ribonucleic acid (HCV RNA) < 1.2 log10 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830159|NCT01292226|B1|Baseline|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830179|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830160|NCT01292226|P1|Participant Flow|Mycophenolate Mofetil (MMF) Monotherapy|Participants received an initial dose of MMF 1 gram (g), orally (PO), twice per day (BID), started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830161|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830162|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830163|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830164|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830165|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830166|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830167|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830168|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830169|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830170|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830171|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830172|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830173|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830174|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830175|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830176|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830177|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830178|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830180|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830181|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830182|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830183|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830184|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830185|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830186|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830221|NCT01292135|E1|Reported Event|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830187|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830188|NCT01292226|O1|Outcome|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830189|NCT01292226|E1|Reported Event|MMF Monotherapy|Participants received an initial dose of MMF 1 g, PO, BID, started within 5 days of transplant, for up to 24 weeks. MMF dose could be titrated to a maximum daily dose of 2 g (minimum daily dose was 1 g). Participants also received concurrent antibody induction, cyclosporine, and corticosteroids as needed according to center's practice.
830190|NCT01292187|B3|Baseline|Total|Total of all reporting groups
830191|NCT01292187|B2|Baseline|Placebo Tablets|Patients who did not receive any active treatment, just placebo
830192|NCT01292187|B1|Baseline|rsCT Tablets|Patients who received oral calcitonin as an active treatment
830193|NCT01292187|P2|Participant Flow|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830194|NCT01292187|P1|Participant Flow|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830195|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830196|NCT01292187|O1|Outcome|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830197|NCT01292187|O2|Outcome|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830198|NCT01292187|O1|Outcome|Oral Calcitonin Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830199|NCT01292187|E2|Reported Event|Oral Placebo Tablets|Identical appearing placebo tablets, without active ingredient At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime Group 1). The remaining patients enrolled were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830230|NCT01292005|P1|Participant Flow|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830328|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830200|NCT01292187|E1|Reported Event|Oral rsCT Tablets|Tablets containing 200 μg of recombinant salmon calcitonin, for oral administration. At group assignment the first 60 patients were told to self-administer the tablets once daily at bedtime (Group 1). The remaining patients were told to self-administer once daily at dinner time (Group 2)to determine if there was any food effect. Randomization was done active:placebo, 2:1.
830201|NCT01292135|B3|Baseline|Total|Total of all reporting groups
830202|NCT01292135|B2|Baseline|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830203|NCT01292135|B1|Baseline|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|PCI-32765: 420 mg daily
830204|NCT01292135|P2|Participant Flow|PCI-32765 Plus Bendamustine/Rituximab (BR)|"PCI-32765: 420 mg daily~BR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1 (Cycle 2 to Cycle 6).~Bendamustine; 70 mg/m² on Day 1 and 2 of each cycle (Up to 6 Cycles)"
830205|NCT01292135|P1|Participant Flow|PCI-32765 Plus Fludarabine/Cyclophosphamide/Rituximab (FCR)|"PCI-32765: 420 mg daily~FCR:~Rituximab: 375 mg/m2 on Day 1 of Cycle 1 and a dose of 500 mg/m2 on Day 1(Cycle 2 to Cycle 6).~Fludarabine: 25 mg/m2/day for 3 days (Days 1 to 3) of each cycle~Cyclophosphamide: 250 mg/m2/day for 3 days (Days 1 to 3) of each cycle (Up to 6 Cycle)"
830206|NCT01292135|O2|Outcome|PCI- 32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
830207|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830208|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
830209|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830210|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
830211|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830212|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI-32765: 420 mg daily
830213|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830214|NCT01292135|O2|Outcome|PCI-32765 Plus Fludarabine/ Cyclophosphamide/ Rituximab (FCR)|PCI- 32765: 420 mg daily
830215|NCT01292135|O1|Outcome|PCI-32765 Plus Bendamustine/Rituximab (BR)|PCI-32765: 420 mg daily
830222|NCT01292070|B1|Baseline|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
830223|NCT01292070|P1|Participant Flow|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
830224|NCT01292070|O1|Outcome|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
830225|NCT01292070|E1|Reported Event|Control (CAT) - Experimental (GFD)|Each participant served as their own control: the left arm received the control protein (histamine prick, intradermal diluent and intradermal standardized cat hair allergenic extract (CAT)) and right arm received the experimental protein (human Fcgamma1-Fel d1 (cat allergen) fusion protein (GFD)) administered intradermally (ID). The control arm received CAT at 0.02 milliliters (mL) of 0.01 bioequivalent allergy units (BAU)/mL to 10 BAU/mL (sequentially in 10-fold increments, stopping if dose produced a wheal ≥ 10 millimeters (mm)). The experimental arm received GFD at 0.001 BAU/mL (1/10th the dose of Fel d1 in the lowest dose of CAT) administered at 0.02 mL. Dosing continued sequentially in 10-fold increments until either a wheal of ≥ 10 mm or the maximum dose was reached (maximum of 7 dose increments).
830226|NCT01292005|B3|Baseline|Total|Total of all reporting groups
830227|NCT01292005|B2|Baseline|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830228|NCT01292005|B1|Baseline|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830229|NCT01292005|P2|Participant Flow|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830231|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830232|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830233|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830234|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830235|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830236|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830237|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830238|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830239|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830240|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830241|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830242|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830243|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830244|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830245|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830246|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830247|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830248|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830249|NCT01292005|O2|Outcome|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830250|NCT01292005|O1|Outcome|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830251|NCT01292005|E2|Reported Event|Placebo|Placebo, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830252|NCT01292005|E1|Reported Event|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
830253|NCT01291784|B1|Baseline|Phase 1 MF Subjects|3 subjects were enrolled in the study. The three subjects were treated at a GC1008 dose level of 1 mg/kg given intravenously over approximately 60 minutes and then repeated every 28 days for a total of 6 cycles in the core study period and then an additional 6 cycles in an extension phase.
830254|NCT01291784|P3|Participant Flow|Sub C|Subject C
830255|NCT01291784|P2|Participant Flow|Sub B|Subject B
830256|NCT01291784|P1|Participant Flow|Sub A|Subject A
830257|NCT01291784|O3|Outcome|Sub C|Subject C
830258|NCT01291784|O2|Outcome|Sub B|Subject B
830259|NCT01291784|O1|Outcome|Sub A|Subject A
830260|NCT01291784|O3|Outcome|Sub C|Subject C
830261|NCT01291784|O2|Outcome|Sub B|Subject B
830262|NCT01291784|O1|Outcome|Sub A|Subject A
830263|NCT01291784|O3|Outcome|Sub C|Subject C
830264|NCT01291784|O2|Outcome|Sub B|Subject B
830265|NCT01291784|O1|Outcome|Sub A|Subject A
830266|NCT01291784|O3|Outcome|Sub C|Subject C
830267|NCT01291784|O2|Outcome|Sub B|Subject B
830268|NCT01291784|O1|Outcome|Sub A|Subject A
830269|NCT01291784|O3|Outcome|Sub C|Subject C
830270|NCT01291784|O2|Outcome|Sub B|Subject B
830271|NCT01291784|O1|Outcome|Sub A|Subject A
830272|NCT01291784|E3|Reported Event|Sub C|Subject C
830273|NCT01291784|E2|Reported Event|Sub B|Subject B
830274|NCT01291784|E1|Reported Event|Sub A|Subject A
830275|NCT01291498|B1|Baseline|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
830276|NCT01291498|P1|Participant Flow|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
830277|NCT01291498|O1|Outcome|HIFU Treatment|Allsubjects are planned to have HIFU Treatment
830278|NCT01291498|O1|Outcome|HIFU Treatment|Ablation of the parathyroid gland by HIFU Treatment
830279|NCT01291498|O1|Outcome|HIFU Treatment|This is a single arm study, all subjects are planned to receive HIFU treatment
830280|NCT01291498|E1|Reported Event|HIFU Treatment|This is a single arm study, all subjects are planned to received HIFU treatment
830281|NCT01291277|B3|Baseline|Total|Total of all reporting groups
830282|NCT01291277|B2|Baseline|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830283|NCT01291277|B1|Baseline|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830284|NCT01291277|P2|Participant Flow|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830285|NCT01291277|P1|Participant Flow|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830286|NCT01291277|O2|Outcome|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830287|NCT01291277|O1|Outcome|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830288|NCT01291277|E2|Reported Event|Ligation 2-week Interval|"Endoscopic variceal ligation performed at 2-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830289|NCT01291277|E1|Reported Event|Ligation: 1-week Interval|"Endoscopic variceal ligation performed at 1-week intervals~Endoscopic Variceal Ligation: Ligation of esophageal varices"
830290|NCT01291264|B1|Baseline|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
830291|NCT01291264|P1|Participant Flow|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
830292|NCT01291264|O1|Outcome|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
830293|NCT01291264|E1|Reported Event|Men Who Have Sex With Men|The study population consisted of asymptomatic and symptomatic MSM that could provide approximately 25 ml of first catch urine (FCU), and two clinician-collected pharyngeal and rectal swabs.
830294|NCT01291225|B3|Baseline|Total|Total of all reporting groups
830295|NCT01291225|B2|Baseline|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
830296|NCT01291225|B1|Baseline|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
830297|NCT01291225|P2|Participant Flow|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
830298|NCT01291225|P1|Participant Flow|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
830299|NCT01291225|O4|Outcome|Farms--Pickaway/Morrow Counties|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
830354|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830300|NCT01291225|O3|Outcome|Farms--Ross County|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
830301|NCT01291225|O2|Outcome|Playground--Circleville|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
830302|NCT01291225|O1|Outcome|Playground--Chillicothe|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
830303|NCT01291225|O2|Outcome|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
830304|NCT01291225|O1|Outcome|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
830305|NCT01291225|E2|Reported Event|Farms|The Farm Arm will consist of farm audits with safety checklists and KAP surveys about farm safety.
830306|NCT01291225|E1|Reported Event|Playground|The playground arm of the study will consist of playground audits and KAP surveys about playground safety in both Chillicothe and Circleville, Ohio.
830307|NCT01291173|B5|Baseline|Total|Total of all reporting groups
830308|NCT01291173|B4|Baseline|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830309|NCT01291173|B3|Baseline|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830310|NCT01291173|B2|Baseline|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830311|NCT01291173|B1|Baseline|Placebo|Placebo capsule taken once daily for up to 11 weeks
830312|NCT01291173|P4|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830313|NCT01291173|P3|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830314|NCT01291173|P2|Participant Flow|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830315|NCT01291173|P1|Participant Flow|Placebo|Placebo capsule taken once daily for up to 11 weeks
830316|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830317|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830318|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830319|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830320|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830321|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830322|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830323|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830324|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830325|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830326|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830327|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830329|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830330|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830331|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830332|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830333|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830334|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830335|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830336|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830337|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830338|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830339|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830340|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830341|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830342|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830343|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830344|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830345|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830346|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830347|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830348|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830349|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830350|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830351|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830352|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830353|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830356|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830357|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830358|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830359|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830360|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830361|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830362|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830363|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830364|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830365|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830366|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830367|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830368|NCT01291173|O4|Outcome|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830369|NCT01291173|O3|Outcome|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830370|NCT01291173|O2|Outcome|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830371|NCT01291173|O1|Outcome|Placebo|Placebo capsule taken once daily for up to 11 weeks
830372|NCT01291173|E4|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 70 mg|SPD489 70mg capsule taken once-daily for up to 11 weeks
830373|NCT01291173|E3|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 50 mg|SPD489 50mg capsules taken once-daily for up to 11 weeks
830374|NCT01291173|E2|Reported Event|Lisdexamfetamine Dimesylate (SPD489) 30 mg|SPD489-30mg capsules taken once daily for up to 11 weeks
830375|NCT01291173|E1|Reported Event|Placebo|Placebo capsule taken once daily for up to 11 weeks
830376|NCT01291160|B3|Baseline|Total|Total of all reporting groups
830377|NCT01291160|B2|Baseline|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830396|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
830378|NCT01291160|B1|Baseline|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830379|NCT01291160|P2|Participant Flow|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830380|NCT01291160|P1|Participant Flow|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830381|NCT01291160|O2|Outcome|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830382|NCT01291160|O1|Outcome|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830416|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
830383|NCT01291160|E2|Reported Event|Sham Device|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.~Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830384|NCT01291160|E1|Reported Event|Epiflo Treatment|"The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.~Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first."
830385|NCT01291108|B5|Baseline|Total|Total of all reporting groups
830386|NCT01291108|B4|Baseline|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
830387|NCT01291108|B3|Baseline|Bimatoprost Followed by Bimatoprost + AGN-210669|bimatoprost 0.03% applied as 1 drop in each eye every evening for Month 1 followed by bimatoprost 0.03% + AGN-210669 applied as 1 drop of each treatment in both eyes every evening for Month 2.
830388|NCT01291108|B2|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening for Month 2.
830389|NCT01291108|B1|Baseline|AGN-210669 Followed by AGN-210669 + Bimatoprost|AGN-210669 0.05% applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
830390|NCT01291108|P6|Participant Flow|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830391|NCT01291108|P5|Participant Flow|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
830392|NCT01291108|P4|Participant Flow|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
830393|NCT01291108|P3|Participant Flow|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830394|NCT01291108|P2|Participant Flow|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
830395|NCT01291108|P1|Participant Flow|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
831355|NCT01289015|B2|Baseline|Placebo|Placebo : Topical; applied once daily for two weeks
830397|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830398|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830399|NCT01291108|O3|Outcome|Combined Adjunctives|Combined adjunctives refer to the combined groups of ’AGN-210669 0.05% + bimatoprost’ and ’bimatoprost + AGN-210669 0.05%’. The first treatment is applied as 1 drop in each eye every evening for Month 1 followed by AGN-210669 0.05% + bimatoprost 0.03% applied as 1 drop of each treatment in both eyes every evening for Month 2.
830400|NCT01291108|O2|Outcome|Bimatoprost Followed by Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830401|NCT01291108|O1|Outcome|AGN-210669 Followed by AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830402|NCT01291108|E6|Reported Event|Bimatoprost + Bimatoprost Vehicle|bimatoprost ophthalmic solution 0.03% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830403|NCT01291108|E5|Reported Event|Bimatoprost + AGN-210669|bimatoprost ophthalmic solution 0.03% + AGN-210669 0.05% applied as 1 drop of each treatment in both eyes every evening during Month 2.
830404|NCT01291108|E4|Reported Event|Bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1.
830405|NCT01291108|E3|Reported Event|AGN-210669 + Bimatoprost Vehicle|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop of each treatment in both eyes every evening during Month 2.
830406|NCT01291108|E2|Reported Event|AGN-210669 + Bimatoprost|AGN-210669 0.05% + bimatoprost ophthalmic solution 0.03% applied as 1 drop of each treatment in both eyes every evening during Month 2.
830407|NCT01291108|E1|Reported Event|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1.
830408|NCT01291056|B3|Baseline|Total|Total of all reporting groups
830409|NCT01291056|B2|Baseline|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
830410|NCT01291056|B1|Baseline|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
830411|NCT01291056|P2|Participant Flow|Placebo, Then Clomiphene Citrate|Placebo, then Clomiphene Citrate 50 milligrams daily
830412|NCT01291056|P1|Participant Flow|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
830413|NCT01291056|O2|Outcome|Placebo|Placebo
830414|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
830415|NCT01291056|O2|Outcome|Placebo|Placebo
830418|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
830419|NCT01291056|O2|Outcome|Placebo|Placebo
830420|NCT01291056|O1|Outcome|Clomiphene Citrate|Clomiphene Citrate 50 milligrams daily
830421|NCT01291056|E2|Reported Event|Placebo, Then Clomiphene Citrate|Placebo daily, then Clomiphene Citrate 50 milligrams daily
830422|NCT01291056|E1|Reported Event|Clomiphene Citrate, Then Placebo|Clomiphene Citrate 50 milligrams daily, then Placebo daily
830423|NCT01291017|B1|Baseline|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830424|NCT01291017|P1|Participant Flow|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830425|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830426|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830427|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830428|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830429|NCT01291017|O1|Outcome|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830430|NCT01291017|E1|Reported Event|PD0332991|"PD0332991 125 mg PO days 1 - 21~PD0332991: PD0332991 125 mg PO days 1 - 21"
830431|NCT01290978|B1|Baseline|ChloraPrep , DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
830432|NCT01290978|P1|Participant Flow|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
830433|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
830434|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
830435|NCT01290978|O2|Outcome|DuraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
830436|NCT01290978|O1|Outcome|ChloraPrep|Subject's back was applied with 2 skin preps (ChloraPrep and DuraPrep), one on each side of subject's back per randomization schedule.
830437|NCT01290978|E1|Reported Event|ChloraPrep, DuraPrep|Subject's back was visually divide into 2. Applied each prep per manufacturer's instruction on either right or left of back according to randomization schedule
830438|NCT01290952|B3|Baseline|Total|Total of all reporting groups
830439|NCT01290952|B2|Baseline|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
830440|NCT01290952|B1|Baseline|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
830441|NCT01290952|P2|Participant Flow|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
830442|NCT01290952|P1|Participant Flow|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
830443|NCT01290952|O2|Outcome|Off-pump Bypass Surgery|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
830444|NCT01290952|O1|Outcome|On-pump Bypass Surgery|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
830445|NCT01290952|O2|Outcome|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
830446|NCT01290952|O1|Outcome|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
830447|NCT01290952|E2|Reported Event|On-pump|"coronary artery bypass graft with cardiopulmonary bypass (CPB/CAB)~On-pump bypass surgery: is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body."
830448|NCT01290952|E1|Reported Event|Off Pump|"Off-pump coronary artery bypass graft (OPCAB) using mandatory a stabilization device and advisable, but not mandatory, a heart positioner~Off-pump bypass surgery: is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally."
830449|NCT01290913|B1|Baseline|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
830450|NCT01290913|P1|Participant Flow|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
830451|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
830452|NCT01290913|O1|Outcome|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
830453|NCT01290913|E1|Reported Event|Omalizumab, Oral Desensitization|Omalizumab treatment and oral peanut desensitization
830454|NCT01290887|B3|Baseline|Total|Total of all reporting groups
830523|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
830524|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
830455|NCT01290887|B2|Baseline|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830456|NCT01290887|B1|Baseline|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830457|NCT01290887|P2|Participant Flow|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830458|NCT01290887|P1|Participant Flow|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830459|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830460|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830461|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830462|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830463|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830464|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830465|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830466|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830467|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830661|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830468|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830469|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830470|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830471|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830472|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830473|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830474|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830475|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830476|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830477|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830478|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830479|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830525|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
830526|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
830480|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830481|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830482|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830483|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830484|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830485|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830486|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830487|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830488|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830489|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830490|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830491|NCT01290887|O3|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830492|NCT01290887|O2|Outcome|Previous Reslizumab-Treated Subpopulation|The subpopulation of particpants who were treated with reslizumab at a variety of dosages in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830493|NCT01290887|O1|Outcome|Previous Placebo-Treated Subpopulation|The subpopulation of particpants who were treated with placebo in the previous double-blind studies. These participants were treated with resllizumab 3.0 mg/kg intravenously once every 4 weeks ( +-7 days) for up to 24 months in this study.
830494|NCT01290887|E1|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for up to 24 months.
830662|NCT01290627|O3|Outcome|Control|Subjects with normal knees
830495|NCT01290822|B1|Baseline|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
830496|NCT01290822|P1|Participant Flow|All Subjects in the Study|"This includes all subjects in the study. Per Arm information is not available for the 1 subject who completed the study. It is also not available for the rest of the subjects as they were withdrawn before being studied."
830497|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
830498|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
830499|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
830500|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
830501|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
830502|NCT01290822|O1|Outcome|All Subjects in the Study|This includes all subjects in the study
830503|NCT01290822|E1|Reported Event|All Subjects in the Study|This includes all subjects in the study
830504|NCT01290796|B1|Baseline|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830505|NCT01290796|P1|Participant Flow|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830506|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830527|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
830528|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
830507|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830508|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830509|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830510|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830511|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830512|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830513|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830514|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
831163|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
830515|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830516|NCT01290796|O1|Outcome|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830517|NCT01290796|E1|Reported Event|Ajust Adjustable Single-Incision Sling|"Urinary incontinence sling~Ajust Adjustable Single-Incision Sling: The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment."
830518|NCT01290757|B3|Baseline|Total|Total of all reporting groups
830519|NCT01290757|B2|Baseline|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
830520|NCT01290757|B1|Baseline|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
830521|NCT01290757|P2|Participant Flow|Sequence: Capsugel - Qualicaps - Capsugel - Qualicaps|Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps (TRTR)
830522|NCT01290757|P1|Participant Flow|Sequence: Qualicaps - Capsugel - Qualicaps - Capsugel|Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel, followed by Dabigatran 150mg in currently approved Qualicaps, followed by Dabigatran 150mg in new Capsugel (RTRT)
830529|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
830530|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
830531|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
830532|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
830533|NCT01290757|O2|Outcome|Qualicaps|Dabigatran 150mg in currently approved Qualicaps
830534|NCT01290757|O1|Outcome|Capsugel|Dabigatran 150mg in new Capsugel
830535|NCT01290757|E2|Reported Event|Capsugel|Dabigatran 150mg in Capsugel
830536|NCT01290757|E1|Reported Event|Qualicaps|Dabigatran 150mg in Qualicaps
830537|NCT01290731|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830538|NCT01290731|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830539|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830540|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830541|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830542|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830663|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830543|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830544|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830545|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830546|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830547|NCT01290731|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable of at Week 4, and undetectable HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830548|NCT01290731|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24 (PR 24). Treatment was to be stopped at Week 24 in participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48 (PR 48).
830549|NCT01290718|B1|Baseline|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
830629|NCT01290666|P1|Participant Flow|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
830630|NCT01290666|O1|Outcome|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
830550|NCT01290718|P1|Participant Flow|Capecitabine Plus (+) Trastuzumab|Participants received capecitabine 900 milligrams per square meter (mg/m^2) orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
830551|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
830552|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
830553|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
830554|NCT01290718|O1|Outcome|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
830555|NCT01290718|E1|Reported Event|Capecitabine + Trastuzumab|Participants received capecitabine 900 mg/m^2 orally, twice daily on Days 1 to 14 followed by a 7 day rest period each 3-week cycle, along with trastuzumab 8 mg/kg iv on Day 1 of the first 3-week cycle, followed by 6 mg/kg iv once every 3 weeks until progressive disease or unacceptable toxicity.
830556|NCT01290679|B3|Baseline|Total|Total of all reporting groups
830557|NCT01290679|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830558|NCT01290679|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830559|NCT01290679|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830560|NCT01290679|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830561|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830684|NCT01290536|O1|Outcome|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
830562|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830563|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830564|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830565|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830566|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830567|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830568|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830569|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830633|NCT01290640|B2|Baseline|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
830570|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830571|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830572|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830573|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830574|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830575|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830576|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830577|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830578|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830579|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830580|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830685|NCT01290536|E1|Reported Event|Yttrium-90 Liver Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
830581|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830582|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830583|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830584|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830585|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830586|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830587|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830588|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830631|NCT01290666|E1|Reported Event|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
830589|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830590|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830591|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830592|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830593|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830594|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830595|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830596|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830597|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830598|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830599|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830600|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
831181|NCT01289418|B2|Baseline|Health Care Workers in Toronto|Health Care Workers from Toronto
830601|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830602|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830603|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830604|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830605|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830606|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830607|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830608|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830609|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830610|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830611|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830612|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830613|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830614|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830615|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830616|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830617|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830618|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830619|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830620|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
831182|NCT01289418|B1|Baseline|Health Care Workers in Quebec|Health care workers from Quebec
830621|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830622|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830623|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830624|NCT01290679|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830625|NCT01290679|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830626|NCT01290679|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 48 (PR 48).
830627|NCT01290679|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a/b (PegIFN alpha-2a/b) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a/b (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
830628|NCT01290666|B1|Baseline|GORE® BIO-A® Fistula Plug|"All patients in study receive the GORE® BIO-A® Fistula Plug.~Fistula Plug: Bioabsorbable fistula plug"
830632|NCT01290640|B3|Baseline|Total|Total of all reporting groups
830635|NCT01290640|P2|Participant Flow|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
830636|NCT01290640|P1|Participant Flow|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|Subjects implanted with a DePuy fixed-bearing Total Condylar III (TC3) TKA
830637|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
830638|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
830639|NCT01290640|O2|Outcome|Subjects With DePuy PFC Fixed Bearing TC3 TKA|
830640|NCT01290640|O1|Outcome|Subjects With DePuy PFC Rotating Platform TC3 TKA|
830641|NCT01290640|E2|Reported Event|Subjects Implanted With a DePuy Fixed-bearing Total Condylar I|
830642|NCT01290640|E1|Reported Event|Subjects Implanted With a DePuy PFC Rotating Platform TC3 TKA|
830643|NCT01290627|B4|Baseline|Total|Total of all reporting groups
830644|NCT01290627|B3|Baseline|Control|Subjects with normal knees
830645|NCT01290627|B2|Baseline|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830646|NCT01290627|B1|Baseline|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830647|NCT01290627|P3|Participant Flow|Control|Subjects with normal knees
830648|NCT01290627|P2|Participant Flow|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830649|NCT01290627|P1|Participant Flow|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830650|NCT01290627|O3|Outcome|Control|Subjects with normal knees
830651|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830652|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830653|NCT01290627|O3|Outcome|Control|Subjects with normal knees
830654|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830655|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830656|NCT01290627|O3|Outcome|Control|Subjects with normal knees
830657|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830658|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830659|NCT01290627|O3|Outcome|Control|Subjects with normal knees
830660|NCT01290627|O2|Outcome|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830664|NCT01290627|O1|Outcome|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830665|NCT01290627|E3|Reported Event|Control|Subjects with normal knees
830666|NCT01290627|E2|Reported Event|Knee Prosthesis Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830667|NCT01290627|E1|Reported Event|Knee Prosthesis LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
830668|NCT01290614|B3|Baseline|Total|Total of all reporting groups
830669|NCT01290614|B2|Baseline|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
830670|NCT01290614|B1|Baseline|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
830671|NCT01290614|P2|Participant Flow|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
830672|NCT01290614|P1|Participant Flow|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
830673|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
830767|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830768|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830674|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
830675|NCT01290614|O2|Outcome|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
830676|NCT01290614|O1|Outcome|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
830677|NCT01290614|E2|Reported Event|Control - Usual Care|"Patients assigned to control will continue to receive care from their VA provider.~Usual Care: Patients in the control arm will continue to receive usual care from their VA providers."
830678|NCT01290614|E1|Reported Event|Pharmacist Intervention|Pharmacist based QI program: Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
830679|NCT01290536|B1|Baseline|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
830680|NCT01290536|P1|Participant Flow|Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
830681|NCT01290536|O3|Outcome|Other Tumors - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
830682|NCT01290536|O2|Outcome|Neuroendocrine - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
830683|NCT01290536|O1|Outcome|Colorectal - Yttrium-90 Radioembolization|Selective internal radiation therapy using Yttrium-90 glass microspheres (TheraSphere)
831183|NCT01289418|P1|Participant Flow|Health Care Workers|Health care workers from all hospitals
830686|NCT01290523|B1|Baseline|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
830687|NCT01290523|P1|Participant Flow|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
830688|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
830689|NCT01290523|O1|Outcome|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
830690|NCT01290523|E1|Reported Event|Yttrium-90 Liver Radioembolization|"Patients who receive liver-directed therapy with Yttrium-90 glass microspheres (TheraSphere)~Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere): Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery"
830691|NCT01290484|B1|Baseline|Sildenafil|Male and female subjects between the ages of 6 months and 10 years, weighing at least 8 kg and had been given a diagnosis of a lymphatic malformation of at least 3 cm based on clinical and radiologic criteria. Macrocystic, microcystic, or mixed lymphatic malformations involving any location on the body were included. Lymphatic malformations associated with an incomplete response to previous treatments, a risk of functional or aesthetic impairment, or local complications were included.
830692|NCT01290484|P1|Participant Flow|Sildenafil|Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day).
830693|NCT01290484|O1|Outcome|Sildenafil|The primary outcome was the effect of sildenafil on lymphatic malformation volume. Response to sildenafil was characterized by any decrease in lymphatic malformation volume. Lymphatic malformations volumes were assessed blindly by MRI volume segmentation analysis at baseline and after 20 weeks of sildenafil. 4 subjects had a lymphatic malformation volume decrease.
830769|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830770|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830771|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830694|NCT01290484|E1|Reported Event|Sildenafil|Adverse events reported while one sildenafil were minimal. All subjects tolerated the prescribed medication dose. One subject developed an upper respiratory tract infection and experienced temporary hearing loss due to fluid accumulation. This was resolved completely and she experienced no further hearing loss while on sildenafil. Four parents requested to have the child continue sildenafil after study completion.
830695|NCT01290341|B3|Baseline|Total|Total of all reporting groups
830696|NCT01290341|B2|Baseline|Placebo|Topical; applied once daily for two weeks.
830697|NCT01290341|B1|Baseline|NAFT-600|Topical; applied once daily for two weeks
830698|NCT01290341|P2|Participant Flow|Placebo|Topical; applied once daily for two weeks.
830699|NCT01290341|P1|Participant Flow|NAFT-600|Topical; applied once daily for two weeks
830700|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
830701|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
830702|NCT01290341|O2|Outcome|Placebo|Topical; applied once daily for two weeks.
830703|NCT01290341|O1|Outcome|NAFT-600|Topical; applied once daily for two weeks
830704|NCT01290341|E2|Reported Event|Placebo|Topical; applied once daily for two weeks.
830705|NCT01290341|E1|Reported Event|NAFT-600|Topical; applied once daily for two weeks
830706|NCT01290263|B3|Baseline|Total|Total of all reporting groups
830707|NCT01290263|B2|Baseline|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
830708|NCT01290263|B1|Baseline|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830709|NCT01290263|P5|Participant Flow|All Cohort B Participants: AMG 386 + Bevacizumab|Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830710|NCT01290263|P4|Participant Flow|Cohort B Phase II: AMG 386 30 mg/kg + Bevacizumab|Participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the maximum tolerated AMG 386 dose established in the Phase I Cohort B study, AMG 386 of 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830711|NCT01290263|P3|Participant Flow|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg + kg."
830712|NCT01290263|P2|Participant Flow|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830713|NCT01290263|P1|Participant Flow|Cohort A: AMG 386 30 mg/kg|Cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
830746|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
831184|NCT01289418|O1|Outcome|Health Care Workers From CHUQ Hospitals|
830714|NCT01290263|O2|Outcome|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg."
830715|NCT01290263|O1|Outcome|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830716|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
830717|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830718|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
830719|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830720|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
830721|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830772|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830722|NCT01290263|O2|Outcome|Cohort B Phase I Dose Level +1: AMG 386 30 mg/kg + Bevacizumab|"Cohort B Phase I Dose Level +1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.~As of June 2014, the maximum tolerated dose (MTD) of bevacizumab + AMG 386 was determined to be dose level +1, AMG 386 30 mg/kg."
830723|NCT01290263|O1|Outcome|Cohort B Phase I Dose Level 0: AMG 386 15 mg/kg + Bevacizumab|Cohort B Phase I Dose Level 0 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting dose AMG 386 of 15 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830724|NCT01290263|O2|Outcome|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
830725|NCT01290263|O1|Outcome|All Cohort B Participants: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830726|NCT01290263|E2|Reported Event|Cohort A: AMG 386 30 mg/kg|All cohort A participants received AMG 386 intravenously (IV) at 30 mg/kg on days 1, 8, 15 and 22 of each 28 day cycle. Participants were treated until disease progression or unacceptable toxicity.
830727|NCT01290263|E1|Reported Event|Cohort B: AMG 386 + Bevacizumab|All Phase I & II Cohort B participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the assigned AMG 386 dose of 15 mg/kg or 30 mg/kg intravenously (IV) on days 1, 8, 15 and 22. Participants were treated until disease progression or unacceptable toxicity.
830728|NCT01290224|B1|Baseline|Sham Procedure + Scrambler Treatment|
830729|NCT01290224|P1|Participant Flow|Sham Procedure + Scrambler Treatment|
830730|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
830731|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
830732|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
830733|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
830734|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
830735|NCT01290224|O2|Outcome|Scrambler Therapy (Day 2)|
830736|NCT01290224|O1|Outcome|Sham Procedure (Day 1 )|
830737|NCT01290224|O1|Outcome|Sham Procedure + Scrambler Treatment|
830738|NCT01290224|E1|Reported Event|Sham Procedure + Scrambler Treatment|
830739|NCT01290094|B1|Baseline|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830740|NCT01290094|P1|Participant Flow|Ibandronate|Participants received 3 milligrams (mg) ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830741|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830742|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830743|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830744|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830745|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
831119|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
830747|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830748|NCT01290094|O1|Outcome|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for a total of 12 months (total of 4 injections).
830749|NCT01290094|E1|Reported Event|Ibandronate|Participants received 3 mg ibandronate via intravenous injection, every 3 months for 9 months (total of 4 injections).
830750|NCT01290068|B3|Baseline|Total|Total of all reporting groups
830751|NCT01290068|B2|Baseline|Monofocal IOL|Monofocal IOL, bilateral implantation
830752|NCT01290068|B1|Baseline|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
830753|NCT01290068|P2|Participant Flow|Monofocal IOL|Monofocal IOL, bilateral implantation
830754|NCT01290068|P1|Participant Flow|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
830755|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
830756|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
830757|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
830758|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
830759|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
830760|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
830761|NCT01290068|O2|Outcome|Monofocal IOL|Monofocal IOL, bilateral implantation
830762|NCT01290068|O1|Outcome|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
830763|NCT01290068|E2|Reported Event|Monofocal IOL|Monofocal IOL, bilateral implantation
830764|NCT01290068|E1|Reported Event|Multifocal IOL|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL, with or without astigmatism correction, bilateral implantation
830765|NCT01290029|B1|Baseline|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830766|NCT01290029|P1|Participant Flow|Cinacalcet 0.25 mg/kg|Participants were to receive a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830773|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830774|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830775|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830776|NCT01290029|O1|Outcome|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830777|NCT01290029|E1|Reported Event|Cinacalcet 0.25 mg/kg|Participants received a single oral dose of 0.25 mg/kg cinacalcet on day 1.
830778|NCT01289990|B14|Baseline|Total|Total of all reporting groups
830779|NCT01289990|B13|Baseline|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830780|NCT01289990|B12|Baseline|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830781|NCT01289990|B11|Baseline|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
830782|NCT01289990|B10|Baseline|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830783|NCT01289990|B9|Baseline|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830784|NCT01289990|B8|Baseline|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
830785|NCT01289990|B7|Baseline|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830786|NCT01289990|B6|Baseline|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830787|NCT01289990|B5|Baseline|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
830788|NCT01289990|B4|Baseline|Sitagliptin 100 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100 mg: Sitagliptin once daily"
830789|NCT01289990|B3|Baseline|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
831185|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid email address
830790|NCT01289990|B2|Baseline|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830791|NCT01289990|B1|Baseline|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
830792|NCT01289990|P13|Participant Flow|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830793|NCT01289990|P12|Participant Flow|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830794|NCT01289990|P11|Participant Flow|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
830795|NCT01289990|P10|Participant Flow|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830796|NCT01289990|P9|Participant Flow|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830797|NCT01289990|P8|Participant Flow|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
830798|NCT01289990|P7|Participant Flow|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830799|NCT01289990|P6|Participant Flow|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830800|NCT01289990|P5|Participant Flow|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
830801|NCT01289990|P4|Participant Flow|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
830802|NCT01289990|P3|Participant Flow|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
831085|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
830803|NCT01289990|P2|Participant Flow|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
830804|NCT01289990|P1|Participant Flow|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
830805|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830806|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830807|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830808|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830809|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830810|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830811|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830812|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830813|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830814|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830815|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830816|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830817|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830818|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830819|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830820|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830821|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830822|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830823|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830824|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830825|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830826|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830827|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830828|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830829|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830830|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830831|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830832|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830833|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830834|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830835|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830836|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830837|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830838|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830839|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830840|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830841|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830842|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830843|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830844|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830845|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830846|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830847|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830848|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830849|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830850|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830851|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830852|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830853|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830854|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830855|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830856|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830857|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830858|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830859|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830860|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830861|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830862|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830863|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830864|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830865|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830866|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830867|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830868|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830869|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830870|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830871|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830872|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830873|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830874|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830875|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830876|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830877|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830878|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830879|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830880|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830881|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830882|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830883|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830884|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830885|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830886|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830887|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830888|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830889|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830890|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830891|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830892|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830893|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830894|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
831086|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
830895|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830896|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830897|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830898|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830899|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830900|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830901|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830902|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830903|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830904|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830905|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830906|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830907|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830908|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830909|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830910|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830911|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830912|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830913|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830914|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830915|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830916|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830917|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830918|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830919|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830920|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830921|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830922|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830923|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830924|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830925|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830926|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830927|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830928|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830929|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830930|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830931|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830932|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830933|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830934|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830935|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830936|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830937|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830938|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830939|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830940|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830941|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830942|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830943|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830944|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830945|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830946|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830947|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830948|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830949|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830950|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830951|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830952|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830953|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830954|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830955|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830956|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
831087|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
830957|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830958|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830959|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830960|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830961|NCT01289990|O13|Outcome|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830962|NCT01289990|O12|Outcome|BI 10773 High (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830963|NCT01289990|O11|Outcome|BI 10773 Low (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830964|NCT01289990|O10|Outcome|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830965|NCT01289990|O9|Outcome|BI 10773 High (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830966|NCT01289990|O8|Outcome|BI 10773 Low (Metformin)|"Patients rolled over from trial 1245.23~BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose~BI 10773: BI 10773 tablets once daily"
830967|NCT01289990|O7|Outcome|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching BI 10773 once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching BI 10773 high dose"
830968|NCT01289990|O6|Outcome|BI 10773 High (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
830969|NCT01289990|O5|Outcome|BI 10773 Low (Pioglitazone)|"Patients rolled over from trial 1245.19~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 high dose"
830970|NCT01289990|O4|Outcome|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching BI 10773 high dose~Placebo: Placebo matching BI 10773 low dose~Sitagliptin 100mg: Sitagliptin once daily"
830971|NCT01289990|O3|Outcome|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching BI 10773 / Sitagliptin once daily~Placebo: Placebo matching BI 10773 low dose~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830972|NCT01289990|O2|Outcome|BI 10773 High (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching BI 10773 low dose"
831120|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
830973|NCT01289990|O1|Outcome|BI 10773 Low (Drug Naive)|"Patients rolled over from trial 1245.20~BI 10773 tablets once daily~BI 10773: BI 10773 tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching BI 10773 high dose"
830974|NCT01289990|E13|Reported Event|Placebo (Metformin+Sulfonylurea)|"Patients rolled over from 1245.23~Placebo tablets matching Empagliflozin~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830975|NCT01289990|E12|Reported Event|Empagliflozin 25 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830976|NCT01289990|E11|Reported Event|Empagliflozin 10 mg (Metformin+Sulfonylurea)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
830977|NCT01289990|E10|Reported Event|Placebo (Metformin)|"Patients rolled over from trial 1245.23~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830978|NCT01289990|E9|Reported Event|Empagliflozin 25 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830979|NCT01289990|E8|Reported Event|Empagliflozin 10 mg (Metformin)|"Patients rolled over from trial 1245.23~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg~Empagliflozin 10 mg: Empagliflozin 10 mg once daily"
830980|NCT01289990|E7|Reported Event|Placebo (Pioglitazone)|"Patients rolled over from trial 1245.19~Placebo tablets matching Empagliflozin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Empagliflozin 25 mg"
830981|NCT01289990|E6|Reported Event|Empagliflozin 25 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 25 mg tablets once daily~Empagliflozin 25 mg: Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Empagliflozin 10 mg"
830982|NCT01289990|E5|Reported Event|Empagliflozin 10 mg (Pioglitazone)|"Patients rolled over from trial 1245.19~Empagliflozin 10 mg tablets once daily~Empagliflozin 10 mg: Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Empagliflozin 25 mg"
830983|NCT01289990|E4|Reported Event|Sitagliptin 100mg (Drug Naive)|"Patients rolled over from trial 1245.20~Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 25 mg~Placebo: Placebo matching Empagliflozin 10 mg~Sitagliptin 100mg: Sitagliptin once daily"
830984|NCT01289990|E3|Reported Event|Placebo (Drug Naive)|"Patients rolled over from trial 1245.20~Placebo tablets matching Empagliflozin / Sitagliptin once daily~Placebo: Placebo matching Empagliflozin 10 mg~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
830985|NCT01289990|E2|Reported Event|Empagliflozin 25 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 25 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 10 mg"
830986|NCT01289990|E1|Reported Event|Empagliflozin 10 mg (Drug Naive)|"Patients rolled over from trial 1245.20~Empagliflozin 10 mg tablets once daily~Placebo: Placebo matching Sitagliptin~Placebo: Placebo matching Empagliflozin 25 mg"
830987|NCT01289847|B1|Baseline|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830988|NCT01289847|P1|Participant Flow|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830989|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830990|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830991|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830992|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830993|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830994|NCT01289847|O1|Outcome|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830995|NCT01289847|E1|Reported Event|Gammaplex|Gammaplex: GAMMAPLEX 5g/100 mL, dose is 300–800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
830996|NCT01289821|B1|Baseline|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
830997|NCT01289821|P1|Participant Flow|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
831121|NCT01289574|E3|Reported Event|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831122|NCT01289574|E2|Reported Event|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
830998|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
830999|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
831000|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
831001|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
831002|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
831088|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831003|NCT01289821|O1|Outcome|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m^2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m^2 D/L‑folinic acid or 200 mg/m^2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m^2 IV bolus injection immediately followed by a 5-FU 2400 mg/m^2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
831004|NCT01289821|E1|Reported Event|Regorafenib + Oxaliplatin/Folinic Acid/5-FU (mFOLFOX6)|On Day 1, participants received 85 mg/m2 oxaliplatin as a 2-hour intravenous (IV) infusion and folinic acid (either 400 mg/m2 D/L folinic acid or 200 mg/m2 L-folinic acid) as a 2-hour IV infusion. Once the initial infusion was completed, participants received 5-FU 400 mg/m2 IV bolus injection immediately followed by a 5-FU 2400 mg/m2 IV infusion for 46 hours. The next cycle of mFOLFOX6 was administered on Day 15 to 17. Participants received Regorafenib (Stivarga, BAY73-4506) 160 mg orally (po) once daily (qd) on Days 4 to 10 and Days 18 to 24. One cycle comprised 28 days.
831005|NCT01289782|B3|Baseline|Total|Total of all reporting groups
831006|NCT01289782|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831007|NCT01289782|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831008|NCT01289782|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831009|NCT01289782|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831010|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831011|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831012|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831123|NCT01289574|E1|Reported Event|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
831124|NCT01289548|B4|Baseline|Total|Total of all reporting groups
831186|NCT01289418|O1|Outcome|Health Care Workers|Health care workers with a valid e-mail address
831187|NCT01289418|E1|Reported Event|Health Care Workers From CHUQ Hospitals|
831013|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831014|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831015|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831016|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831017|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831018|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831019|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831039|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831089|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
831020|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831021|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831022|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831023|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831024|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831025|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831026|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831027|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831028|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831029|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831030|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831031|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831125|NCT01289548|B3|Baseline|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831188|NCT01289392|B4|Baseline|Total|Total of all reporting groups
831032|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831033|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831034|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831035|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831036|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831037|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831038|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831084|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831040|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831041|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831042|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831043|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831044|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831045|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831046|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831047|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831048|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831049|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831050|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831051|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831126|NCT01289548|B2|Baseline|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831052|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831053|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831054|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831055|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831056|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831057|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831058|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831059|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831060|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831061|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831062|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831063|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831064|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831065|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831066|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831067|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831068|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831069|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831070|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831071|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831127|NCT01289548|B1|Baseline|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831289|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831072|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831073|NCT01289782|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831074|NCT01289782|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831075|NCT01289782|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
831076|NCT01289782|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
831077|NCT01289639|B4|Baseline|Total|Total of all reporting groups
831078|NCT01289639|B3|Baseline|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831079|NCT01289639|B2|Baseline|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831080|NCT01289639|B1|Baseline|Arm 1|"matching placebo for fenofibrate 1 po qd~matching placebo for pioglitazone 1 po qd"
831081|NCT01289639|P3|Participant Flow|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831082|NCT01289639|P2|Participant Flow|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831083|NCT01289639|P1|Participant Flow|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
831090|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831091|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831092|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
831093|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831094|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831095|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
831096|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831097|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831098|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
831099|NCT01289639|O3|Outcome|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831100|NCT01289639|O2|Outcome|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831101|NCT01289639|O1|Outcome|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
831102|NCT01289639|E3|Reported Event|Arm 3|"pioglitazone 30 mg po qd~matching placebo for fenofibrate 1 po qd"
831103|NCT01289639|E2|Reported Event|Arm 2|"micronized fenofibrate 200 mg 1 po qd~matching placebo for pioglitazone 1 po qd"
831104|NCT01289639|E1|Reported Event|Arm 1|"matching placebo for fenofibrate 1 capsule po qd~matching placebo for pioglitazone 1 capsule po qd"
831105|NCT01289574|B4|Baseline|Total|Total of all reporting groups
831106|NCT01289574|B3|Baseline|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831107|NCT01289574|B2|Baseline|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831108|NCT01289574|B1|Baseline|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
831109|NCT01289574|P3|Participant Flow|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831110|NCT01289574|P2|Participant Flow|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831111|NCT01289574|P1|Participant Flow|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
831112|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831113|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831114|NCT01289574|O1|Outcome|Vehicle Control Cream|Vehicle control cream for twice daily topical application to the face
831115|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831116|NCT01289574|O2|Outcome|0.025% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831117|NCT01289574|O1|Outcome|Vehicle Control Cream|ASC-J9: Cream for twice daily topical application to the face
831118|NCT01289574|O3|Outcome|0.1% ASC-J9 Cream|ASC-J9: Cream for twice daily topical application to the face
831128|NCT01289548|P3|Participant Flow|Recipient PIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831129|NCT01289548|P2|Participant Flow|Donor RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831130|NCT01289548|P1|Participant Flow|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min
831131|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831132|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831133|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831134|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831135|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831136|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831137|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831138|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831139|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831140|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831141|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831142|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831143|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831235|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831144|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831145|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831146|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831147|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831148|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831149|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831150|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831151|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831152|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831153|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831154|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831155|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831156|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831157|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831158|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831159|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831160|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831161|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831162|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831164|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831165|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831166|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831167|NCT01289548|O3|Outcome|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831168|NCT01289548|O2|Outcome|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831169|NCT01289548|O1|Outcome|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831170|NCT01289548|E3|Reported Event|Recipient +RIPC|recipients receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; donors only have a deflated blood pressure cuff around their leg for 30 minutes.
831171|NCT01289548|E2|Reported Event|Donor + RIPC|Donors receive remote ischaemic preconditioning after anaesthesia induction and before surgery started; recipients only have a deflated blood pressure cuff around their leg for 30 minutes.
831172|NCT01289548|E1|Reported Event|Control|patients (both donors and recipients) had a deflated cuff placed on the left lower limb for 30 min.
831173|NCT01289522|B1|Baseline|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m2 IV every 2 weeks during the maintenance therapy.~Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
831199|NCT01289392|E2|Reported Event|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831233|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831174|NCT01289522|P1|Participant Flow|Cetuximab|"cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² over 60 minutes weekly on subsequent administrations~500mg/m2 every 2 weeks during the maintenance therapy. Drug: -Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles~Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles G-CSF support mandatory after each cycle of chemotherapy. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the 4th cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks."
831175|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according~cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
831176|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according~cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
831177|NCT01289522|O1|Outcome|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according~cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m² IV every 2 weeks during the maintenance therapy. Drug: Cisplatin IV : 75 mg/m² every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m² every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg/m²/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
831178|NCT01289522|E1|Reported Event|Cetuximab|"Patients receive four cycles of chemotherapy comprising cetuximab IV plus docetaxel IV over 1 hour and cisplatin IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of the fourth cycle of chemotherapy, patients receive a maintenance therapy with cetuximab every 2 weeks. Treatment will be continued until disease progression or unacceptable toxicities according cetuximab IV: - 400 mg/m² over 120 minutes on day 1 of cycle 1 only.~250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.~500mg/m2 IV every 2 weeks during the maintenance therapy.~Drug: Cisplatin IV : 75 mg/m2 every 3 weeks for 4 cycles Drug: Docetaxel IV : 75 mg/m2 every 3 weeks for 4 cycles~G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy.~Biopsies: No intervention, only biopsy for translational project."
831179|NCT01289418|B4|Baseline|Total|Total of all reporting groups
831180|NCT01289418|B3|Baseline|Health Care Workers in Halifax|Health Care Workers from Halifax
831189|NCT01289392|B3|Baseline|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
831190|NCT01289392|B2|Baseline|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831191|NCT01289392|B1|Baseline|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831192|NCT01289392|P3|Participant Flow|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
831193|NCT01289392|P2|Participant Flow|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831194|NCT01289392|P1|Participant Flow|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831195|NCT01289392|O3|Outcome|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
831196|NCT01289392|O2|Outcome|Oral Appliance|"Alternative treatment for obstructive sleep apnea patients~Oral Appliance (OA) : Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831197|NCT01289392|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831198|NCT01289392|E3|Reported Event|Physical Exercise|"Aerobic and resistance physical exercises~Physical Exercise : aerobic and resistance Physical exercise, three times a week, for four months"
831232|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831200|NCT01289392|E1|Reported Event|Continuous Positive Airway Pressure (CPAP)|"CPAP is the gold standard treatment~Continuous Positive Airway Pressure (CPAP) : Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise"
831201|NCT01289210|B1|Baseline|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
831202|NCT01289210|P1|Participant Flow|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then administered weekly for 3 weeks in a 4 week cycle over 3 cycles.
831203|NCT01289210|O1|Outcome|VTX-2337 Plus Radiation|Day 1: radiation therapy; Day 2: VTX-2337 3.0mg/m2 administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then admnistered weekly for 3 weeks in a 4 week cycle over 3 cycles.
831204|NCT01289210|E1|Reported Event|VTX-2337 Plus Radiation|VTX-2337 plus radiotherapy: Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
831205|NCT01289119|B7|Baseline|Total|Total of all reporting groups
831206|NCT01289119|B6|Baseline|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831207|NCT01289119|B5|Baseline|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831208|NCT01289119|B4|Baseline|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831209|NCT01289119|B3|Baseline|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831210|NCT01289119|B2|Baseline|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831211|NCT01289119|B1|Baseline|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831212|NCT01289119|P6|Participant Flow|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831213|NCT01289119|P5|Participant Flow|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831214|NCT01289119|P4|Participant Flow|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831215|NCT01289119|P3|Participant Flow|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831216|NCT01289119|P2|Participant Flow|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831217|NCT01289119|P1|Participant Flow|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831218|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831288|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831219|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831220|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831221|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831222|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831223|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831224|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831225|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831226|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831227|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831228|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831229|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831230|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831231|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831234|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831236|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831237|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831238|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831239|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831240|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831241|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831242|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831243|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831244|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831245|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831246|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831247|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831248|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831249|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831250|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831251|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831252|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831253|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831254|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831255|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831256|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831257|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831258|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831259|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831260|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831261|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831262|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831263|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831264|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831265|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831266|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831267|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831268|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831269|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831411|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
831270|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831271|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831272|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831273|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831274|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831275|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831276|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831277|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831278|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831279|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831280|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831281|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831282|NCT01289119|O2|Outcome|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831283|NCT01289119|O1|Outcome|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831284|NCT01289119|O6|Outcome|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831285|NCT01289119|O5|Outcome|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831286|NCT01289119|O4|Outcome|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831287|NCT01289119|O3|Outcome|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831348|NCT01289028|O1|Outcome|Nilotinib|Per Protocol population
831290|NCT01289119|E6|Reported Event|Pioglitazone + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin, 25 mg tablets orally once daily for up to 16 weeks.
831291|NCT01289119|E5|Reported Event|Pioglitazone|Participants continued to receive their stable dose of pioglitazone with or without metformin and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831292|NCT01289119|E4|Reported Event|Metformin + Alogliptin Add-on Therapy|Participants continued to receive their stable dose of metformin (≥1000 mg/day) and also received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831293|NCT01289119|E3|Reported Event|Metformin|Participants continued to receive their stable dose of Metformin (≥1000 mg/day) and also received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks.
831294|NCT01289119|E2|Reported Event|Alogliptin Monotherapy|Participants received alogliptin 25 mg tablets, orally, once daily for up to 16 weeks.
831295|NCT01289119|E1|Reported Event|Placebo|Participants received alogliptin placebo-matching tablets, orally once daily for up to 16 weeks
831296|NCT01289080|B3|Baseline|Total|Total of all reporting groups
831297|NCT01289080|B2|Baseline|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831298|NCT01289080|B1|Baseline|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831299|NCT01289080|P2|Participant Flow|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831300|NCT01289080|P1|Participant Flow|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831301|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
831302|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831303|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
831304|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831305|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
831306|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831307|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairement were administered 3 mg brexpiprazole on Day 1.
831308|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831309|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831310|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
833034|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
831311|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831312|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831313|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831314|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831315|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831316|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831317|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
831318|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831319|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831320|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831321|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831322|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831323|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831324|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831325|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole Day 1.
831326|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831327|NCT01289080|O2|Outcome|Renally Impaired|Participants with severe renal impairment were administered 3 mg brexpiprazole on Day 1.
831328|NCT01289080|O1|Outcome|Normal|Participants with normal renal function were administered 3 mg brexpiprazole on Day 1.
831329|NCT01289080|E1|Reported Event|Brexpiprazole 3mg|Participants with normal renal function and severe renal impairment were administered 3 mg brexpiprazole.
831330|NCT01289041|B1|Baseline|All Patients|
831331|NCT01289041|P1|Participant Flow|All Patients|
831332|NCT01289041|O3|Outcome|All Patients|
831333|NCT01289041|O2|Outcome|Non-Activated Pl3K|
831334|NCT01289041|O1|Outcome|Activated Pl3K|
831335|NCT01289041|O3|Outcome|All Patients|
831336|NCT01289041|O2|Outcome|Non-Activated Pl3K|
831337|NCT01289041|O1|Outcome|Activated Pl3K|
831338|NCT01289041|O3|Outcome|All Patients|
831339|NCT01289041|O2|Outcome|Non-Activated Pl3K|
831340|NCT01289041|O1|Outcome|Activated Pl3K|
831341|NCT01289041|E1|Reported Event|All Patients|
831342|NCT01289028|B1|Baseline|Nilotinib|
831343|NCT01289028|P1|Participant Flow|Nilotinib|
831344|NCT01289028|O1|Outcome|Nilotinib|
831345|NCT01289028|O1|Outcome|Nilotinib|
831346|NCT01289028|O1|Outcome|Nilotinib|
831347|NCT01289028|O1|Outcome|Nilotinib|
831356|NCT01289015|B1|Baseline|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
831357|NCT01289015|P2|Participant Flow|Placebo|Placebo : Topical; applied once daily for two weeks
831358|NCT01289015|P1|Participant Flow|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
831359|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
831360|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
831361|NCT01289015|O2|Outcome|Placebo|Placebo : Topical; applied once daily for two weeks
831362|NCT01289015|O1|Outcome|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
831363|NCT01289015|E2|Reported Event|Placebo|Placebo : Topical; applied once daily for two weeks
831364|NCT01289015|E1|Reported Event|NAFT-600|NAFT-600 : Topical; applied once daily for two weeks
831365|NCT01288911|B3|Baseline|Total|Total of all reporting groups
831366|NCT01288911|B2|Baseline|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831367|NCT01288911|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831368|NCT01288911|P2|Participant Flow|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831369|NCT01288911|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831370|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831371|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831372|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831373|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831374|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831412|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
831375|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831376|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831377|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831378|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831379|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831380|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831381|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831382|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831383|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831384|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831385|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831386|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831387|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831388|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831389|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831390|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831391|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831548|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831392|NCT01288911|O2|Outcome|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831393|NCT01288911|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831394|NCT01288911|E2|Reported Event|Bicalutamide|Participants received bicalutamide 50 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831395|NCT01288911|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg orally once daily until confirmed radiographic disease progression, skeletal-related event or the initiation of a new antineoplastic therapy.
831396|NCT01288859|B1|Baseline|All Study Participants|All participants followed all the periods
831397|NCT01288859|P6|Participant Flow|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
831398|NCT01288859|P5|Participant Flow|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
831399|NCT01288859|P4|Participant Flow|Control Cream|Subjects consumed 3 nut cream portions (33g each).
831400|NCT01288859|P3|Participant Flow|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
831401|NCT01288859|P2|Participant Flow|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
831402|NCT01288859|P1|Participant Flow|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
831403|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
831404|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
831405|NCT01288859|O4|Outcome|Control|Subjects consumed white bread or nut cream
831406|NCT01288859|O3|Outcome|Free Cocoa Polyphenol|subjects consumed nut creams added with cocoa polyphenols
831407|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
831408|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
831409|NCT01288859|O6|Outcome|Free Curcumin|Subjects consumed bread added with free curcumin
831410|NCT01288859|O5|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed nut creams added with encapsulate cocoa-polyphenols
831413|NCT01288859|O2|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread containing encapsulated curcumin plus PQG (i.e. Piperine, Quercetin and Genistein)
831414|NCT01288859|O1|Outcome|Encapsulated Curcumin|subjects consumed bread containing encapsulated curcumin
831415|NCT01288859|O6|Outcome|Encapsulated Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with encapsulated cocoa polyphenols
831416|NCT01288859|O5|Outcome|Free Cocoa Polyphenols|subjects consumed cocoa-nut cream enriched with cocoa polyphenols in the free form
831417|NCT01288859|O4|Outcome|Control Cream|subjects consumed cocoa-nut cream
831418|NCT01288859|O3|Outcome|Encapsulated Curcumin + PQG|subjects consumed bread enriched with encapsulated curcumin plus piperine, quercetin and genistein
831419|NCT01288859|O2|Outcome|Encapsulated Curcumin|subjects consumed bread enriched with encapsulated curcumin
831420|NCT01288859|O1|Outcome|Free Curcumin|subjects consumed bread enriched with free curcumin
831421|NCT01288859|E6|Reported Event|Free Curcumin|Subjects consumed 2 portions of bread enriched with free curcumin (1g/100g portion, i.e. 2g/day)
831422|NCT01288859|E5|Reported Event|Encapsulated Cocoa Polyphenols|Subjects consumed 3 nut cream portions (33g each) enriched with encapsulated cocoa polyphenols at dosage of 1.5g/day.
831423|NCT01288859|E4|Reported Event|Control Cream|Subjects consumed 3 nut cream portions (33g each).
831424|NCT01288859|E3|Reported Event|Free Cocoa Polyphenol|Subjects consumed 3 nut cream portions (33g each) enriched with cocoa polyphenols at dosage of 1.5g/day.
831425|NCT01288859|E2|Reported Event|Encapsulated Curcumin + PQG|Subjects consumed 2 bread portions/day of bread enriched with micro-capsules containing curcumin at dosage of 1 g/100 g plus 0.1% of Piperine, Quercetin and Genistein (PQG) (2g curcumin + 0.2g PQG/day) for one day.
831426|NCT01288859|E1|Reported Event|Encapsulated Curcumin|Subjects consumed 2 bread portions/day of bread enriched with micro-encapsulated curcumin(1g/100g portion, i.e. 2g/day)
831427|NCT01288781|B3|Baseline|Total|Total of all reporting groups
831428|NCT01288781|B2|Baseline|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831429|NCT01288781|B1|Baseline|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831430|NCT01288781|P2|Participant Flow|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831431|NCT01288781|P1|Participant Flow|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831432|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831433|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831434|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831435|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831549|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831436|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831437|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831438|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831439|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831440|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831441|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831442|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831443|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831444|NCT01288781|O2|Outcome|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831445|NCT01288781|O1|Outcome|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831446|NCT01288781|E2|Reported Event|Placebo|Placebo (LACTOSE MONOHYDRATE) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831447|NCT01288781|E1|Reported Event|Acetazolamide|Arm 1: ACETAZOLAMIDE (250mg) will be given to subjects at fifteen, twenty and thirty two hours post hypoxic exposure (3777m).
831448|NCT01288729|B3|Baseline|Total|Total of all reporting groups
831449|NCT01288729|B2|Baseline|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
831450|NCT01288729|B1|Baseline|Group 1 - Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
831451|NCT01288729|P2|Participant Flow|Group 2 - Teflon Cathetar, the Steel|Participants will alternate between wearing the Quick-Set Teflon catheter for 7 days, then the Quick-Set Teflon for 7 days. They will wear each set twice starting with the Quick-Set Teflon set.
831452|NCT01288729|P1|Participant Flow|Group 1: Steel Cathetar, Then Teflon|Participants will alternate between wearing the Sure-T Steel Infusion Set Catheter for 7 days, then the Quick-Set Teflon for 7 days.They will wear each set twice starting with the Sure-T Steel Infusion Set.
831571|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831453|NCT01288729|O2|Outcome|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
831454|NCT01288729|O1|Outcome|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
831455|NCT01288729|E2|Reported Event|Quick-Set Teflon Catheter|"Participants will wear the Quick-Set Teflon catheter for 7 days (for a total of 14 days for the duration of the study).~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
831456|NCT01288729|E1|Reported Event|Sure-T Steel Infusion Set Catheter|"Participants will wear Sure-T Steel Infusion Set Catheter for 7 days (for a total of 14 days for the duration of the study)~Sure-T Stell Infusion Set Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time~Quick-Set Teflon Catheter: Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time"
831457|NCT01288612|B4|Baseline|Total|Total of all reporting groups
831458|NCT01288612|B3|Baseline|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831459|NCT01288612|B2|Baseline|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831460|NCT01288612|B1|Baseline|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831461|NCT01288612|P3|Participant Flow|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831502|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831503|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831462|NCT01288612|P2|Participant Flow|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831463|NCT01288612|P1|Participant Flow|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831464|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831465|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831466|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831467|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831468|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831469|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831523|NCT01288469|E3|Reported Event|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831470|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831471|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831472|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831473|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831474|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831475|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831476|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831477|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831478|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831479|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831504|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831480|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831481|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831482|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831483|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831484|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831485|NCT01288612|O3|Outcome|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831486|NCT01288612|O2|Outcome|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831487|NCT01288612|O1|Outcome|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831488|NCT01288612|E3|Reported Event|Transnasal Endoscopy at Mobile Unit|"Unsedated transnasal endoscopy in mobile research van~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831489|NCT01288612|E2|Reported Event|Transnasal Endoscopy at Hospital Unit|"Unsedated transnasal endoscopy at hospital unit.~Transnasal Endoscopy: Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure."
831490|NCT01288612|E1|Reported Event|Sedated Endoscopy|"Sedated esophagogastroduodenoscopy with biopsy~Sedated Endoscopy: The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl."
831491|NCT01288534|B1|Baseline|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
831492|NCT01288534|P1|Participant Flow|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
831493|NCT01288534|O1|Outcome|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
831494|NCT01288534|E1|Reported Event|Radiation Treatment|Radiation Therapy: Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
831495|NCT01288469|B4|Baseline|Total|Total of all reporting groups
831496|NCT01288469|B3|Baseline|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831497|NCT01288469|B2|Baseline|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831498|NCT01288469|B1|Baseline|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831499|NCT01288469|P3|Participant Flow|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831500|NCT01288469|P2|Participant Flow|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831501|NCT01288469|P1|Participant Flow|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) subcutaneous (SC) injection every two weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831505|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831506|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831507|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831508|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831509|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831510|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831511|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831512|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831513|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831514|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831515|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831516|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831517|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831518|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831519|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831520|NCT01288469|O3|Outcome|Alirocumab + Atorvastatin 80 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831521|NCT01288469|O2|Outcome|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831522|NCT01288469|O1|Outcome|Placebo + Atorvastatin 80 mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831524|NCT01288469|E2|Reported Event|Alirocumab + Atorvastatin 10 mg|Alirocumab 150 mg SC injection Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks.
831525|NCT01288469|E1|Reported Event|Placebo + Atorvastatin 80mg|Placebo (for alirocumab) SC injection Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
831526|NCT01288443|B7|Baseline|Total|Total of all reporting groups
831527|NCT01288443|B6|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831528|NCT01288443|B5|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831529|NCT01288443|B4|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831530|NCT01288443|B3|Baseline|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831531|NCT01288443|B2|Baseline|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831532|NCT01288443|B1|Baseline|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831533|NCT01288443|P6|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831534|NCT01288443|P5|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831535|NCT01288443|P4|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831536|NCT01288443|P3|Participant Flow|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831537|NCT01288443|P2|Participant Flow|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831538|NCT01288443|P1|Participant Flow|Placebo|Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose.
831539|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831540|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831541|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831542|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831543|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831544|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831545|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831546|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831547|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831550|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831551|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831552|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831553|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831554|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831555|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831556|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831557|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831558|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831559|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831560|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831561|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831562|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831563|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831564|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831565|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831566|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831567|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831568|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831569|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831570|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
833035|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
831572|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831573|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831574|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831575|NCT01288443|O6|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831576|NCT01288443|O5|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831577|NCT01288443|O4|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831578|NCT01288443|O3|Outcome|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831579|NCT01288443|O2|Outcome|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831580|NCT01288443|O1|Outcome|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831581|NCT01288443|E6|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831582|NCT01288443|E5|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg Q4W and alternating placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831583|NCT01288443|E4|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831584|NCT01288443|E3|Reported Event|Alirocumab 100 mg Q2W|Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831585|NCT01288443|E2|Reported Event|Alirocumab 50 mg Q2W|Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose.
831586|NCT01288443|E1|Reported Event|Placebo|Placebo (for alirocumab) Q2W for 12-weeks in combination with atorvastatin stable dose.
831587|NCT01288287|B1|Baseline|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
831588|NCT01288287|P1|Participant Flow|All Patients|Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.
831589|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831590|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831591|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831832|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831592|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831593|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831594|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831595|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831596|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831597|NCT01288287|O2|Outcome|Week 12 Disease Activity Score (DAS) Non-Responders|Patients who fail to achieve a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831598|NCT01288287|O1|Outcome|Week 12 Disease Activity Score (DAS) Responders|Patients achieving a reduction from Baseline in a Disease Activity Score 28-joint count (Erythrocyte Sedimentation Rate) [DAS28(ESR)] score of greater than 1.2 points at Week 12
831599|NCT01288287|E1|Reported Event|Safety Set (All Patients)|"Patient presenting with Rheumatoid Arthritis (RA) and having prescribed certolizumab pegol (CZP, Cimzia®) at the clinic.~Safety Set consists of all patients entered into the study who took at least one dose of Certolizumab Pegol."
831600|NCT01288209|B3|Baseline|Total|Total of all reporting groups
831601|NCT01288209|B2|Baseline|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
831602|NCT01288209|B1|Baseline|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
831603|NCT01288209|P2|Participant Flow|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
831604|NCT01288209|P1|Participant Flow|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
831605|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831606|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831607|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831608|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831609|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831610|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831611|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831673|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831612|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831613|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831614|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831615|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831616|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831617|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831618|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831619|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
833036|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
831620|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831621|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831622|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831623|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831624|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831625|NCT01288209|O2|Outcome|TMC435 100 mg 24 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831626|NCT01288209|O1|Outcome|TMC435 100 mg 12 Wks + PR24/48|Participants received TMC435 100 mg once daily with PegIFNα-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable plasma HCV RNA levels at Week 12. All other participants continued PR until Week 48.
831627|NCT01288209|E2|Reported Event|TMC435 100 mg 24 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin ( PR) for 24 weeks (Wks). Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
831674|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831628|NCT01288209|E1|Reported Event|TMC435 100 mg 12 Wks + PR 24/48|Participants received TMC435 100 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks (Wks) followed by PR until Week 24. Treatment was stopped at Week 24 if participants achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.2 log10 IU/mL detectable or undetectable at Week 4, and undetectable HCV RNA at Week 12. All other participants continued PR until Week 48.
831629|NCT01288079|B5|Baseline|Total|Total of all reporting groups
831630|NCT01288079|B4|Baseline|Placebo|
831631|NCT01288079|B3|Baseline|60 mg QD Duloxetine|
831632|NCT01288079|B2|Baseline|4 mg BID TC-5214|
831633|NCT01288079|B1|Baseline|1 mg BID TC-5214|
831634|NCT01288079|P4|Participant Flow|Placebo|
831635|NCT01288079|P3|Participant Flow|60 mg QD Duloxetine|
831636|NCT01288079|P2|Participant Flow|4 mg BID TC-5214|
831637|NCT01288079|P1|Participant Flow|1 mg BID TC-5214|
831638|NCT01288079|O4|Outcome|Placebo|
831639|NCT01288079|O3|Outcome|60 mg QD Duloxetine|
831640|NCT01288079|O2|Outcome|4 mg BID TC-5214|
831641|NCT01288079|O1|Outcome|1 mg BID TC-5214|
831642|NCT01288079|E4|Reported Event|Placebo|
831643|NCT01288079|E3|Reported Event|60 mg QD Duloxetine|
831644|NCT01288079|E2|Reported Event|4 mg BID TC-5214|
831645|NCT01288079|E1|Reported Event|1 mg BID TC-5214|
831646|NCT01288027|B1|Baseline|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831647|NCT01288027|P1|Participant Flow|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831648|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831649|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831650|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831651|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831652|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831653|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831654|NCT01288027|O1|Outcome|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831655|NCT01288027|E1|Reported Event|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
831656|NCT01287897|B5|Baseline|Total|Total of all reporting groups
831851|NCT01287195|B1|Baseline|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831657|NCT01287897|B4|Baseline|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831658|NCT01287897|B3|Baseline|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831659|NCT01287897|B2|Baseline|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831660|NCT01287897|B1|Baseline|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831661|NCT01287897|P4|Participant Flow|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831662|NCT01287897|P3|Participant Flow|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831663|NCT01287897|P2|Participant Flow|PF-04236921 10 Milligram (mg)|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831664|NCT01287897|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831665|NCT01287897|O4|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831666|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831667|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831668|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831669|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831670|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831671|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831672|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
833455|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
831675|NCT01287897|O3|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831676|NCT01287897|O2|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831677|NCT01287897|O1|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831678|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831679|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831680|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831681|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831682|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831683|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831684|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831685|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831686|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831687|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831688|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831689|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831690|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831691|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831692|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831693|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831694|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831695|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831696|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831697|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831698|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831699|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831700|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831701|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831702|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831703|NCT01287897|O2|Outcome|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831704|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831705|NCT01287897|O3|Outcome|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
833456|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
831706|NCT01287897|O2|Outcome|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831707|NCT01287897|O1|Outcome|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831708|NCT01287897|E4|Reported Event|PF-04236921 200 mg|PF-04236921 200 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831709|NCT01287897|E3|Reported Event|PF-04236921 50 mg|PF-04236921 50 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831710|NCT01287897|E2|Reported Event|PF-04236921 10 mg|PF-04236921 10 mg administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831711|NCT01287897|E1|Reported Event|Placebo|Placebo administered SC in the anterolateral right and left thighs on Day 1 and Day 28. Each participant received 2 injections due to the double-dummy design of the study.
831712|NCT01287832|B3|Baseline|Total|Total of all reporting groups
831713|NCT01287832|B2|Baseline|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831714|NCT01287832|B1|Baseline|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831715|NCT01287832|P2|Participant Flow|High-dose Daptomycin|Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831716|NCT01287832|P1|Participant Flow|High Dose Vancomycin|Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831717|NCT01287832|O2|Outcome|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831718|NCT01287832|O1|Outcome|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831719|NCT01287832|E2|Reported Event|High-dose Daptomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831720|NCT01287832|E1|Reported Event|High Dose Vancomycin|Vancomycin vs. daptomycin: Vancomycin dosed to achieve a trough of 15-20 microgram/mL vs. daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
831721|NCT01287754|B3|Baseline|Total|Total of all reporting groups
831722|NCT01287754|B2|Baseline|Untreated|Participants without the EGFR mutation were followed for overall survival but did not undergo treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
831723|NCT01287754|B1|Baseline|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
831724|NCT01287754|P2|Participant Flow|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
831725|NCT01287754|P1|Participant Flow|Erlotinib|Participants positive for the epidermal growth factor receptor (EGFR) mutation and who met eligibility criteria received treatment with erlotinib, 150 milligrams (mg) orally once daily until disease progression or unacceptable toxicity.
831726|NCT01287754|O1|Outcome|All Participants|All participants underwent EGFR mutation testing at Screening. Those positive for the EGFR mutation and who met eligibility criteria (n = 3) received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity. The remaining participants (n = 21) were followed for overall survival but did not receive treatment.
831727|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
831728|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
831729|NCT01287754|O2|Outcome|Untreated|Participants without the EGFR mutation were followed for overall survival but did not receive treatment. Additionally, participants positive for the EGFR mutation who were excluded from treatment were followed for overall survival.
831730|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
831731|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
831732|NCT01287754|O1|Outcome|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
831733|NCT01287754|E1|Reported Event|Erlotinib|Participants positive for the EGFR mutation and who met eligibility criteria received treatment with erlotinib, 150 mg orally once daily until disease progression or unacceptable toxicity.
831734|NCT01287611|B3|Baseline|Total|Total of all reporting groups
831735|NCT01287611|B2|Baseline|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
831736|NCT01287611|B1|Baseline|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
831737|NCT01287611|P2|Participant Flow|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
831738|NCT01287611|P1|Participant Flow|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
831739|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|"Eighty four patients were allocated to the control group. Due to expanded Kerr incisions 3 patients in control group did not receive their allocated intervention. In addition, 16 patients in the control group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 65 study group.~Continuously locked closure technique: Uterine Kerr incision will be closed with continuously locked suturing"
831740|NCT01287611|O1|Outcome|Purse String Closure Technique|"Eighty four patients were allocated to the study group. Due to expanded Kerr incisions 4 patients in study group did not receive their allocated intervention. In addition, 29 patients in the study group were lost to follow up and did not come to the sixth week check up. Statistical analysis is based on data from the remaining 51 study group.~Purse string closure technique: Uterine Kerr incision will be closed with purse string suture"
831741|NCT01287611|O2|Outcome|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
831742|NCT01287611|O1|Outcome|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
831743|NCT01287611|E2|Reported Event|Continuously Locked Closure Technique|Continuously locked suturing: Uterine Kerr incision will be closed with continuously locked suturing
831744|NCT01287611|E1|Reported Event|Purse String Closure Technique|Purse string closure: Uterine Kerr incision will be closed with purse string suture
831745|NCT01287416|B3|Baseline|Total|Total of all reporting groups
831746|NCT01287416|B2|Baseline|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831747|NCT01287416|B1|Baseline|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831748|NCT01287416|P2|Participant Flow|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831749|NCT01287416|P1|Participant Flow|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831750|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831751|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831752|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831825|NCT01287221|P1|Participant Flow|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831753|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831754|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831755|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831756|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831853|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831757|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831758|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831759|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831760|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831761|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831826|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831762|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831763|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831764|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831765|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831766|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831767|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831768|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831769|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831770|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831827|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831828|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831771|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831772|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831773|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831774|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831775|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831776|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831777|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831778|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831779|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831829|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831780|NCT01287416|O2|Outcome|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831781|NCT01287416|O1|Outcome|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831782|NCT01287416|E2|Reported Event|Resilience Retreat|The 2-day 14-hour resilience retreat (RR) was divided into cultural teachings and activities, sharing circles, small group discussions, and story telling. The RR included four main components: (1) Seven Sacred Teachings; (2) Self-identity—focused on knowing your identity, the past, and celebrating your history. Following the presentation, participants divided into community groups for discussion and then reconvened with all attendees to share discussion points; (3) Healthy communities—explored and discussed questions regarding healthy communities using both verbal and pictorial explanations; (4) Bracelet-making activity. The RR ended with a sharing circle attended by all participants.
831783|NCT01287416|E1|Reported Event|Applied Suicide Intervention Skills Training (ASIST)|"Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop. ASIST is an intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The training is designed for anyone (especially those in a position of trust), from professionals and volunteers to members of the community. Participants range from those in caring roles to people concerned about family members or friends. The theory is that suicide can be pre¬vented with the help of prepared caregivers. ASIST is designed to help all caregivers become more willing, ready and able to help persons at risk. Just as CPR skills make physical first aid possible, training in suicide intervention develops the skills used in suicide first aid."
831784|NCT01287403|B1|Baseline|Entire Study Population|Includes groups randomized to receive either esterase wholegrain wheat flour first or liquid wholegrain wheat flour first or liquid wholegrain barley flour first or refined wheat flour first or wholegrain wheat flour first or wholegrain barley flour first
831785|NCT01287403|P1|Participant Flow|Six Products (Flours) Assigned Randomly (Cross Over)|"In a crossover design, all subjects were administered the 6 following products in a randomized order:~Esterase wholegrain wheat flour: a cereal flour treated with esterases to release phenolics (positive control for phenolic acids).~Refined wheat flour: a treated cereal flour mixed with milk (negative control).~Liquid whole grain wheat flour: a treated cereal flour mixed with milk.~Liquid wholegrain barley flour: a treated cereal flour mixed with milk.~Wholegrain wheat flour: a treated cereal flour mixed with milk.~Wholegrain barley flour: a treated cereal flour mixed with milk."
831786|NCT01287403|O6|Outcome|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
831787|NCT01287403|O5|Outcome|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
831788|NCT01287403|O4|Outcome|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
831789|NCT01287403|O3|Outcome|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
831790|NCT01287403|O2|Outcome|Refined Wheat Flour|A treated cereal flour mixed with milk(negative control).
831791|NCT01287403|O1|Outcome|Esterase Whole Grain Wheat Flour|A cereal flour treated with esterase to release phenolics (positive control for phenolic acids).
831792|NCT01287403|E6|Reported Event|Wholegrain Barley Flour|A treated cereal flour mixed with milk.
831793|NCT01287403|E5|Reported Event|Wholegrain Wheat Flour|A treated cereal flour mixed with milk.
831794|NCT01287403|E4|Reported Event|Liquid Wholegrain Barley Flour|A treated cereal flour mixed with milk.
831795|NCT01287403|E3|Reported Event|Liquid Whole Grain Wheat Flour|A treated cereal flour mixed with milk.
831796|NCT01287403|E2|Reported Event|Esterase Wholegrain Wheat Flour|A cereal flour treated with esterases to release phenolics (positive control for phenolic acids)
831797|NCT01287403|E1|Reported Event|Refined Wheat Flour|A treated cereal flour mixed with milk (negative control).
831798|NCT01287364|B3|Baseline|Total|Total of all reporting groups
831799|NCT01287364|B2|Baseline|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
831800|NCT01287364|B1|Baseline|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
831801|NCT01287364|P2|Participant Flow|Mometasone Followed by Ciclesonide HFA|mometasone nasal inhalation 200 μg once daily in first intervention period followed by a 7-14 day washout period after which the second intervention of ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily will be administered
831802|NCT01287364|P1|Participant Flow|Ciclesonide HFA Followed by Mometasone|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily in first intervention period, followed by a 7-14 day washout period, after which the second intervention of mometasone nasal inhalation 200 μg once daily will be administered.
831830|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831831|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831803|NCT01287364|O2|Outcome|Treatment Outcomes|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Outcomes Component reflects the perceived outcomes of drug treatment, including longer relief; symptom relief, if both were the same price; for feeling better about your appearance; for fewer problems with irritation to nose; faster relief; and how it makes your nose feel.
831804|NCT01287364|O1|Outcome|Treatment Process|Extraction Method: Principal Component Analysis. Rotation Method: Varimax with Kaiser Normalization. Treatment Process Component reflects preference on items pertaining to the perceived drug treatment process, including ease of use; convenience; flexibility in daily activities; taste; use in public; smell; fewer problems with medication running out of the nose; fewer problems with medication dripping down throat; and number of sprays per dose.
831805|NCT01287364|O3|Outcome|High Minus Low Response Group|Between Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
831806|NCT01287364|O2|Outcome|High Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
831807|NCT01287364|O1|Outcome|Low Response Group|Within Group Standardized Effect Sizes. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
831808|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups..
831809|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85; n = 55), Medium Change (2.08 to 1.74; n = 56), or High Change (6.57 to 2.14; n = 55) groups.
831852|NCT01287195|P1|Participant Flow|Oral OKT3|Participants with ulcerative colitis received 1 milligram (mg) Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831810|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
831811|NCT01287364|O3|Outcome|High Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
831812|NCT01287364|O2|Outcome|Medium Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
831813|NCT01287364|O1|Outcome|Low Change|rTNSS change scores were partitioned into three categories to form the independent variable - Low Change (0.70 to 1.85), Medium Change (2.08 to 1.74), or High Change (6.57 to 2.14) groups.
831814|NCT01287364|O3|Outcome|High Symptoms|Patients were assigned to baseline rTNSS categories of High Symptoms (9.33 - 12.00; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
831815|NCT01287364|O2|Outcome|Medium Symptoms|Patients were assigned to baseline rTNSS categories of Medium Symptoms (7.25 - 9.25; n = 61). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
831816|NCT01287364|O1|Outcome|Low Symptoms|Patients were assigned to baseline rTNSS categories of Low Symptoms(3.00 - 7.17; n = 62). Results reported as difference in mean treatment satisfaction subscale score range 0-100 where higher represent greater satisfaction. TNSS is the sum of individual symptoms of runny nose, sneezing, itchy nose, and nasal congestions. Subjects assess each individual symptom on a scale of 0-3 where: 0 = absent, 1 = mild, 2 = moderate, and 3 = severe. Therefore, rTNSS values range from 0-12 (with 0 representing an absence of symptoms and higher scores reflecting more severe symptoms). Reflective TNSS measures these symptoms over the previous 12-hour time interval.
831817|NCT01287364|O2|Outcome|Average Cronbach's Alpha (Standardized) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
831818|NCT01287364|O1|Outcome|Average Cronbach's Alpha (Raw) Coefficients|Cronbach's alpha coefficient, which is a correlation coefficient ranging from 0.0 to 1.0 with higher coefficients indicating greater reliability. A coefficient of ≥ 0.7 was the standard for evidence of reliability.
831819|NCT01287364|E2|Reported Event|Mometasone|mometasone nasal inhalation 200 μg once daily pooled
831820|NCT01287364|E1|Reported Event|Ciclesonide|ciclesonide hydrofluoroalkane nasal aerosol (HFA) 80 μg once daily pooled
831821|NCT01287221|B3|Baseline|Total|Total of all reporting groups
831822|NCT01287221|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831823|NCT01287221|B1|Baseline|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831824|NCT01287221|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831833|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831834|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831835|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831836|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831837|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831838|NCT01287221|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831839|NCT01287221|O1|Outcome|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831840|NCT01287221|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo capsules twice daily for 12 months. The capsules will contain riboflavin (vitamin B2).
831841|NCT01287221|E1|Reported Event|Rifampicin|Subjects randomized to this arm will receive 300 mg Rifampicin two times a day for 12 months.
831842|NCT01287208|B3|Baseline|Total|Total of all reporting groups
831843|NCT01287208|B2|Baseline|Blinded|Activity monitor with no feedback
831844|NCT01287208|B1|Baseline|Unblinded|Activity monitor with visible and on-line feedback
831845|NCT01287208|P2|Participant Flow|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
831846|NCT01287208|P1|Participant Flow|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
831847|NCT01287208|O2|Outcome|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
831848|NCT01287208|O1|Outcome|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
831849|NCT01287208|E2|Reported Event|Blinded|Subjects wear a blinded activity device and cannot see the activity on the device and cannot log on to the website where the data gets uploaded.
831850|NCT01287208|E1|Reported Event|Unblinded|Subjects wear the activity device and can see the data on the device and on a website where the data is uploaded.
831854|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831855|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831856|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831857|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831858|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831859|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831860|NCT01287195|O1|Outcome|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831861|NCT01287195|E1|Reported Event|Oral OKT3|Participants with ulcerative colitis received 1 mg Oral OKT3 given with 20 mg oral Omeprazole once daily for 30 days.
831862|NCT01287117|B5|Baseline|Total|Total of all reporting groups
831863|NCT01287117|B4|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831864|NCT01287117|B3|Baseline|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831865|NCT01287117|B2|Baseline|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831866|NCT01287117|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831867|NCT01287117|P4|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831868|NCT01287117|P3|Participant Flow|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831869|NCT01287117|P2|Participant Flow|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831870|NCT01287117|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831871|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831872|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831873|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831874|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831875|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831876|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831877|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831878|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831879|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831880|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831881|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831882|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831883|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831884|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831885|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831886|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831887|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831888|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831889|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831890|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831891|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831892|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831893|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831894|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831895|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831896|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831897|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831898|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831899|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831900|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831901|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831902|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831903|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831904|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831905|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831906|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831907|NCT01287117|O4|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831908|NCT01287117|O3|Outcome|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831909|NCT01287117|O2|Outcome|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831910|NCT01287117|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831911|NCT01287117|E4|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
831912|NCT01287117|E3|Reported Event|Omalizumab 150 mg|Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period.
831913|NCT01287117|E2|Reported Event|Omalizumab 75 mg|Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period.
831914|NCT01287117|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
831915|NCT01287065|B1|Baseline|Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM in 1 of 6 Seq|All participants received one of the following three treatments in one of three treatment periods from the Dry Powder Inhaler (DPI) for 14 days: placebo in the morning (AM) and evening (PM), Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM, and FF/VI inhalation powder 100/25 µg PM and placebo AM. Participants were randomized to receive treatment in one of the six following sequences (seq): (1) placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM; (2) placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM; (3) FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, placebo; (4) FF/VI 100/25 µg AM, placebo, FF/VI 100/25 µg PM; (5) FF/VI 100/25 µg PM, placebo, FF/VI 100/25 µg AM; (6) FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, placebo. Each 14 day treatment period was followed by a 14-21 day washout period.
831916|NCT01287065|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, Placebo|Participants received FF/VI 100/25 µg PM, FF/VI 100/25 µg AM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
831944|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831917|NCT01287065|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg PM, Placebo, FF/VI 100/25 µg AM|Participants received FF/VI 100/25 µg PM, placebo, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
831918|NCT01287065|P4|Participant Flow|Sequence 4: FF/VI 100/25 µg AM, Placebo, FF/VI 100/25 µg PM|Participants received FF/VI 100/25 µg AM, placebo, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
831919|NCT01287065|P3|Participant Flow|Sequence 3: FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, Placebo|Participants received FF/VI 100/25 µg AM, FF/VI 100/25 µg PM, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
831920|NCT01287065|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg PM, FF/VI 100/25 µg AM|Participants received placebo, FF/VI 100/25 µg PM, and FF/VI 100/25 µg AM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
831921|NCT01287065|P1|Participant Flow|Sequence 1: Placebo, FF/VI 100/25 µg AM, FF/VI 100/25 µg PM|Participants received placebo, Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) AM, and FF/VI 100/25 µg PM in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 14 days. Each 14 day treatment period was followed by a 14-21 day washout period.
831922|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831923|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831924|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831925|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831926|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
833037|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
831927|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831928|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831929|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831930|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831931|NCT01287065|O3|Outcome|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831932|NCT01287065|O2|Outcome|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831933|NCT01287065|O1|Outcome|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831934|NCT01287065|E3|Reported Event|FF/VI 100/25 µg PM|Participants received FF/VI inhalation powder 100/25 µg PM and placebo AM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831935|NCT01287065|E2|Reported Event|FF/VI 100/25 µg AM|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) inhalation powder 100/25 micrograms (µg) AM and placebo PM from the DPI for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831936|NCT01287065|E1|Reported Event|Placebo|Participants received placebo in the morning (AM) and evening (PM) from the Dry Powder Inhaler (DPI) for 14 days during one of the three treatment periods. Each 14 day treatment period was followed by a 14-21 day washout period.
831937|NCT01287039|B3|Baseline|Total|Total of all reporting groups
831938|NCT01287039|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831939|NCT01287039|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831940|NCT01287039|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831941|NCT01287039|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831942|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831943|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
833457|NCT01283581|O1|Outcome|Delafloxacin IV|Delafloxacin 300 mg, BID
831945|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831946|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831947|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831948|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831949|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831950|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831951|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831952|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831953|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831954|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831955|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831956|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831957|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831958|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831959|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831960|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831961|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831962|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831963|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831964|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831965|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831966|NCT01287039|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831967|NCT01287039|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831968|NCT01287039|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831969|NCT01287039|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
831970|NCT01286818|B1|Baseline|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831971|NCT01286818|P1|Participant Flow|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831972|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
832014|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832015|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832016|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
831973|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831974|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831975|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831988|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831989|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
832404|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
831976|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831977|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831978|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831979|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
832017|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832018|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832019|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
831980|NCT01286818|O1|Outcome|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831981|NCT01286818|E1|Reported Event|FOLFIRI Plus Ramucirumab (IMC-1121B)|"Ramucirumab (IMC-1121B): Intravenous (IV) infusion, 8 milligrams per kilogram (mg/kg) every 2 weeks. Then 1-hour observation followed by chemotherapy with irinotecan, levofolinate, and 5-fluorouracil (FOLFIRI) according to manufacturer's standards. Irinotecan: IV infusion, 180 milligrams per square meter (mg/m^2) every 2 weeks. Levofolinate: IV infusion, 200 mg/m^2 every 2 weeks. 5-fluorouracil (5-FU): 400 mg/m^2 bolus followed by a 2400 mg/m^2 continuous infusion, every 2 weeks.~Antiemetic premedication recommended according to manufacturer's standards but not required prior to ramucirumab drug product infusion. Participants who did not experience unacceptable toxicities during dose limiting toxicity (DLT) assessment period (Day 1, Cycle 1 through Day 1, Cycle 3) who met criteria for treatment continuation received additional cycles of study medication until disease progression, unacceptable toxicity, protocol noncompliance, withdrawal of consent, or Sponsor/investigator decision."
831982|NCT01286805|B3|Baseline|Total|Total of all reporting groups
831983|NCT01286805|B2|Baseline|Control Group|The control group received only a combined spinal-epidural.
831984|NCT01286805|B1|Baseline|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831985|NCT01286805|P2|Participant Flow|Control Group|The control group received only a combined spinal-epidural.
831986|NCT01286805|P1|Participant Flow|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831987|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
832199|NCT01286129|B3|Baseline|Total|Total of all reporting groups
831990|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831991|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
831992|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831993|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
831994|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831995|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
831996|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831997|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
831998|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
831999|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
832000|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
832001|NCT01286805|O2|Outcome|Control Group|The control group received only a combined spinal-epidural.
832002|NCT01286805|O1|Outcome|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
832003|NCT01286805|E2|Reported Event|Control Group|The control group received only a combined spinal-epidural.
832004|NCT01286805|E1|Reported Event|Lumbar Plexus Blockade + CSE|The study group received a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.
832005|NCT01286753|B3|Baseline|Total|Total of all reporting groups
832006|NCT01286753|B2|Baseline|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832007|NCT01286753|B1|Baseline|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832008|NCT01286753|P2|Participant Flow|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against vascular endothelial growth factor receptor 2 (VEGFR).
832009|NCT01286753|P1|Participant Flow|Tyrosine Kinase Inhibitor (TKI) Naive|Vemurafenib 960 milligrams (mg) orally twice daily in participants naive to any prior systemic TKI therapy.
832010|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832011|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832012|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832013|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832020|NCT01286753|O2|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832021|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832022|NCT01286753|O1|Outcome|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832023|NCT01286753|O1|Outcome|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832024|NCT01286753|E2|Reported Event|TKI Experienced|Vemurafenib 960 mg orally twice daily in participants previously treated with TKI therapy active against VEGFR.
832025|NCT01286753|E1|Reported Event|TKI Naive|Vemurafenib 960 mg orally twice daily in participants naive to any prior systemic TKI therapy.
832026|NCT01286740|B1|Baseline|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832027|NCT01286740|P1|Participant Flow|FTC/RPV/TDF|Participants switched from their existing treatment regimen of efavirenz (EFV)/emtricitabine (FTC)/tenofovir disoproxil fumarate (tenofovir DF; TDF) to the FTC 200 mg/rilpivirine (RPV) 25 mg/TDF 300 mg single-table regimen (STR).
832028|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832029|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832030|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832031|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832032|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832033|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832034|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832035|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832036|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832037|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832038|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832039|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832040|NCT01286740|O1|Outcome|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832041|NCT01286740|E1|Reported Event|FTC/RPV/TDF|Participants switched from their existing treatment regimen of EFV/FTC/TDF to the FTC/RPV/TDF STR.
832042|NCT01286558|B3|Baseline|Total|Total of all reporting groups
832043|NCT01286558|B2|Baseline|40 mg Telmisartan and 5 mg Amlodipine FDC|
832044|NCT01286558|B1|Baseline|80 mg Telmisartan and 5 mg Amlodipine FDC|
832045|NCT01286558|P2|Participant Flow|40 mg Telmisartan and 5 mg Amlodipine FDC|
832046|NCT01286558|P1|Participant Flow|80 mg Telmisartan and 5 mg Amlodipine FDC|
832047|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832048|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832049|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832050|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832051|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832052|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832053|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832054|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832055|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832056|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832057|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832058|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832059|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832060|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832061|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832062|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832063|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832064|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832065|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832066|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832067|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832068|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832069|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832070|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832071|NCT01286558|O2|Outcome|40 mg Telmisartan and 5 mg Amlodipine FDC|
832072|NCT01286558|O1|Outcome|80 mg Telmisartan and 5 mg Amlodipine FDC|
832073|NCT01286558|E2|Reported Event|40 mg Telmisartan and 5 mg Amlodipine FDC|
832074|NCT01286558|E1|Reported Event|80 mg Telmisartan and 5 mg Amlodipine FDC|
832075|NCT01286493|B1|Baseline|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
832076|NCT01286493|P1|Participant Flow|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
833458|NCT01283581|E3|Reported Event|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
832077|NCT01286493|O1|Outcome|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
832078|NCT01286493|E1|Reported Event|Rabies Vaccines on Day 0 and 3|"Cell culture Rabies vaccines on day 0 and 3~rabies vaccines on day 0 and 3: All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,28,90,180,360"
832079|NCT01286454|B1|Baseline|Entire Study Population|Includes groups randomized to receive fesoterodine 4 mg IR-BIC fasted first, 10% ER-BIC fasted first, 15% ER-BIC fasted first, 20% ER-BIC fasted first and ER tablets fasted first.
832080|NCT01286454|P11|Participant Flow|Fesoterodine 4 mg 10% ER Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in sixth intervention period. A washout period of approximately 2 weeks was maintained between fifth and sixth intervention period.
832081|NCT01286454|P10|Participant Flow|Fesoterodine 4mg ER Tablet, 20% ER, IR, 15% ER, 10% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832082|NCT01286454|P9|Participant Flow|Fesoterodine 4mg 20% ER, 15% ER, ER Tablet, 10% ER, IR|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832083|NCT01286454|P8|Participant Flow|Fesoterodine 4mg 15% ER, 10% ER, 20% ER, IR, ER Tablet|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832084|NCT01286454|P7|Participant Flow|Fesoterodine 4mg 10% ER, IR, 15% ER, ER Tablet, 20% ER|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832085|NCT01286454|P6|Participant Flow|Fesoterodine 4mg IR, ER Tablet, 10% ER, 20% ER, 15% ER|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832086|NCT01286454|P5|Participant Flow|Fesoterodine 4mg ER Tablet, IR, 20% ER, 10% ER, 15% ER|Single oral dose of fesoterodine 4 mg ER tablet under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832087|NCT01286454|P4|Participant Flow|Fesoterodine 4mg 20% ER, ER Tablet, 15% ER, IR, 10% ER|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg ER tablet under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832088|NCT01286454|P3|Participant Flow|Fesoterodine 4mg 15% ER, 20% ER, 10% ER, ER Tablet, IR|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832120|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
832121|NCT01286454|E6|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
832122|NCT01286454|E5|Reported Event|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
833459|NCT01283581|E2|Reported Event|Linezolid|Linezolid 600 mg, BID
832089|NCT01286454|P2|Participant Flow|Fesoterodine 4mg 10% ER, 15% ER, IR, 20% ER, ER Tablet|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in forth intervention period; and single oral dose of fesoterodine 4 mg ER tablet under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832090|NCT01286454|P1|Participant Flow|Fesoterodine 4mg IR, 10% ER, ER Tablet, 15% ER, 20% ER|Single oral dose of fesoterodine 4 milligram (mg) immediate release (IR) beads-in-capsule (BIC) under fasted condition in first intervention period; followed by single oral dose of fesoterodine 4 mg 10% coated extended release (ER) BIC under fasted condition in second intervention period; then single oral dose of fesoterodine 4 mg ER tablet under fasted condition in third intervention period; then single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in fourth intervention period; and single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in fifth intervention period. A washout period of at least 3 days between intervention periods was maintained.
832091|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
832092|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
832093|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832094|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832095|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832096|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
832097|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
832098|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
832099|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832100|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832101|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832102|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
832103|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
832104|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
832105|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832106|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832107|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832108|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
832109|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
832110|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
832111|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832112|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832113|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832114|NCT01286454|O1|Outcome|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
832115|NCT01286454|O6|Outcome|Fesoterodine 4 mg 10% ER-BIC Fed|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fed condition in the sixth intervention period.
832116|NCT01286454|O5|Outcome|Fesoterodine 4 mg ER Tablet Fasted|Single oral dose of fesoterodine 4 mg ER Tablet under fasted condition in either of the first to fifth intervention periods.
832117|NCT01286454|O4|Outcome|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832118|NCT01286454|O3|Outcome|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832119|NCT01286454|O2|Outcome|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832381|NCT01285518|B2|Baseline|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832123|NCT01286454|E4|Reported Event|Fesoterodine 4 mg 20% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 20% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832124|NCT01286454|E3|Reported Event|Fesoterodine 4 mg 15% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 15% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832125|NCT01286454|E2|Reported Event|Fesoterodine 4 mg 10% ER-BIC Fasted|Single oral dose of fesoterodine 4 mg 10% coated ER-BIC under fasted condition in either of the first to fifth intervention periods.
832126|NCT01286454|E1|Reported Event|Fesoterodine 4 mg IR-BIC Fasted|Single oral dose of fesoterodine 4 mg IR-BIC under fasted condition in either of the first to fifth intervention periods.
832127|NCT01286402|B3|Baseline|Total|Total of all reporting groups
832128|NCT01286402|B2|Baseline|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832129|NCT01286402|B1|Baseline|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832130|NCT01286402|P2|Participant Flow|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832131|NCT01286402|P1|Participant Flow|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832132|NCT01286402|O2|Outcome|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832133|NCT01286402|O1|Outcome|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg, taken orally, taken daily for the 1st 3 days~- 300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832134|NCT01286402|E2|Reported Event|Placebo|"Group receiving placebo~-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832403|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832135|NCT01286402|E1|Reported Event|Bupropion SR (Sustained Release)|"Group receiving bupropion SR medication~Bupropion SR: - 150mg (1 pill), taken orally, taken daily for the 1st 3 days~- 300mg (2 pills), taken orally, taken daily for the rest of the 8 weeks of drug treatment"
832136|NCT01286324|B3|Baseline|Total|Total of all reporting groups
832137|NCT01286324|B2|Baseline|Placebo Tablet|Contained lactose
832138|NCT01286324|B1|Baseline|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
832139|NCT01286324|P2|Participant Flow|Placebo Tablet|Contained lactose
832140|NCT01286324|P1|Participant Flow|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
832141|NCT01286324|O2|Outcome|Placebo Tablet|Contained lactose
832142|NCT01286324|O1|Outcome|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
832143|NCT01286324|E2|Reported Event|Placebo Tablet|Contained lactose
832144|NCT01286324|E1|Reported Event|Chamomile High Grade Extract|Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet
832145|NCT01286311|B3|Baseline|Total|Total of all reporting groups
832146|NCT01286311|B2|Baseline|Control|
832147|NCT01286311|B1|Baseline|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832148|NCT01286311|P2|Participant Flow|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care. After 9 months, control group physicians were provided with lists of their eligible patients and their risk scores.
832149|NCT01286311|P1|Participant Flow|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832150|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
832151|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832152|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
832153|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832154|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
832155|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832156|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
832228|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832157|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832158|NCT01286311|O2|Outcome|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
832159|NCT01286311|O1|Outcome|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832160|NCT01286311|E2|Reported Event|Control|Eligible patients cared for by physicians randomized to the control group will receive usual care.
832161|NCT01286311|E1|Reported Event|Direct-to-patient Tailored Cardiovascular Risk Message System|Eligible patients cared for by physicians randomized to the active intervention group will be mailed a tailored cardiovascular risk message.
832162|NCT01286207|B4|Baseline|Total|Total of all reporting groups
832163|NCT01286207|B3|Baseline|Standard Care|Standard care at onset of migraine attack
832164|NCT01286207|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832165|NCT01286207|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832166|NCT01286207|P3|Participant Flow|Standard Care|Standard care at onset of migraine attack
832167|NCT01286207|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832168|NCT01286207|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832169|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
832170|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832171|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832172|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
832173|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832174|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832175|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
832176|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832177|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832178|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
832179|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832180|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832181|NCT01286207|O3|Outcome|Standard Care|Standard care at onset of migraine attack
832182|NCT01286207|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832183|NCT01286207|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832184|NCT01286207|E3|Reported Event|Standard Care|Standard care at onset of migraine attack
832185|NCT01286207|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832186|NCT01286207|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
832187|NCT01286168|B1|Baseline|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832188|NCT01286168|P1|Participant Flow|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832189|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832190|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832191|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832229|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
833460|NCT01283581|E1|Reported Event|Delafloxacin IV|Delafloxacin 300 mg, BID
832192|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832193|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832194|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832195|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832196|NCT01286168|O1|Outcome|Entire Study Population|Because a paired study design was used (only bilateral procedures), each subject served as her own control. Randomization assigned which side (right or left) would receive the antisepsis interventions, and the contralateral side received standard drain care.
832197|NCT01286168|E2|Reported Event|Control Side|"Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.~Control: Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care."
832198|NCT01286168|E1|Reported Event|Antisepsis Side|"A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days. The drainage bulb will be irrigated with 10ml of 0.125% sodium hypochlorite (Dakin's solution) twice a day.~Sodium hypochlorite (Dakin's Solution): 10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day~Chlorhexidine gluconate disk: Apply one chlorhexidine disk to the intervention drain site(s) and change every three days~Occlusive Adhesive Dressing: A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days."
832200|NCT01286129|B2|Baseline|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
832201|NCT01286129|B1|Baseline|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
832202|NCT01286129|P2|Participant Flow|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
832203|NCT01286129|P1|Participant Flow|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
832204|NCT01286129|O2|Outcome|Allergic Non Asthmatic|Change in nasal lavage eosinophil percentages in allergic non asthmatic at baseline and at 7h post first and last challenge
832205|NCT01286129|O1|Outcome|Allergic Asthmatic|Change in nasal lavage eosinophil percentages in allergic asthmatic at baseline and at 7h post first and last challenge
832206|NCT01286129|O2|Outcome|Allergic Rhinitic Without Asthma|Variation in sputum eosinophil percentage in allergic non asthmatic between baseline value and at 7h following first and last challenge
832207|NCT01286129|O1|Outcome|Allergic Asthmatic|Variation in sputum eosinophil percentage in allergic asthmatic between baseline value and at 7h following first and last challenge
832208|NCT01286129|E2|Reported Event|Allergic Rhinitic Without Asthma|Subjects with allergic rhinitis without asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
832209|NCT01286129|E1|Reported Event|Allergic Asthmatic|Subjects with allergic asthma will undergo nasal allergen provocations with either house dust mite or cat pelt.
832210|NCT01286077|B3|Baseline|Total|Total of all reporting groups
832211|NCT01286077|B2|Baseline|Non-treated Control|no treatment, observation only
832212|NCT01286077|B1|Baseline|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832213|NCT01286077|P2|Participant Flow|Non-treated Control|no treatment, observation only
832214|NCT01286077|P1|Participant Flow|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832215|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832216|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832217|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832218|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832219|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832220|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832221|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832222|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832223|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832224|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832225|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832226|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832227|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832230|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832231|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832232|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832233|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832234|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832235|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832236|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832237|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832238|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832239|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832240|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832241|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832242|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832243|NCT01286077|O2|Outcome|Non-treated Control|no treatment, observation only
832244|NCT01286077|O1|Outcome|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832245|NCT01286077|E2|Reported Event|Non-treated Control|no treatment, observation only
832246|NCT01286077|E1|Reported Event|Bortezomib|bortezomib (Velcade) 1.6 mg/m² bolus injection on Days 1, 8, 15 and 22 every 5 weeks for 4 cycles
832247|NCT01286012|B3|Baseline|Total|Total of all reporting groups
832248|NCT01286012|B2|Baseline|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
832249|NCT01286012|B1|Baseline|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
832250|NCT01286012|P2|Participant Flow|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
832251|NCT01286012|P1|Participant Flow|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
832252|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
832253|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
832254|NCT01286012|O2|Outcome|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
832255|NCT01286012|O1|Outcome|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will be randomized in a 1:1 ratio to receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) or conventional solutions lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks.
832256|NCT01286012|E2|Reported Event|Placebo: Conventional Liquid Bicarbonate|"Control concentrate lacking SFP does not contain SFP (total iron = 0)~Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking iron (placebo) at every dialysis session, for a total duration of 36 weeks."
832257|NCT01286012|E1|Reported Event|SFP in Liquid Bicarbonate|Soluble Ferric Pyrophosphate in liquid bicarbonate: Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
832258|NCT01285947|B3|Baseline|Total|Total of all reporting groups
832259|NCT01285947|B2|Baseline|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
832260|NCT01285947|B1|Baseline|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
832261|NCT01285947|P2|Participant Flow|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
832262|NCT01285947|P1|Participant Flow|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
832263|NCT01285947|O2|Outcome|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
832264|NCT01285947|O1|Outcome|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
832265|NCT01285947|E2|Reported Event|Non-Naive Subjects|Subjects who have previously undergone energy-based dermatologic procedures in the past.
832266|NCT01285947|E1|Reported Event|Naive Subjects|Subjects who have not previously undergone energy-based dermatologic procedures in the past.
832267|NCT01285908|B1|Baseline|All Study Participants|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or Pure Autonomic Failure.
832268|NCT01285908|P3|Participant Flow|Norepinephrine, Then Saline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of norepinephrine followed by IV administration of saline. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
832269|NCT01285908|P2|Participant Flow|Saline, Then Norepinephrine|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees) under two separate conditions, i.e., first following IV administration of saline followed by IV administration of norepinephrine. Measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
832270|NCT01285908|P1|Participant Flow|Baseline|Orthostatic hypotension was measured while lying flat (0 degrees) and at varying tilt angles (20, 40, and 60 degrees). Baseline measures included the following: blood pressure (systolic and diastolic), mean arterial pressure, heart rate, cardiac stroke volume, cardiac output, total peripheral resistance, plasma levels of norepinephrine and dihydroxyphenylglycol.
832271|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a norepinephrine infusion.
832272|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of dihydroxyphenylglycol taken at varying tilt angles following a saline infusion.
832273|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of plasma levels of dihydroxyphenylglycol at varying tilt angles.
832274|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a norepinephrine infusion.
832275|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of plasma levels of norepinephrine taken at varying tilt angles following a saline infusion.
832276|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of plasma levels of norepinephrine at varying tilt angles.
832277|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a norepinephrine infusion.
832278|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of total peripheral resistance taken at varying tilt angles following a saline infusion.
832279|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of total peripheral resistance taken at varying tilt angles.
832280|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a norepinephrine infusion.
832281|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac output taken at varying tilt angles following a saline infusion.
832282|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac output taken at varying tilt angles.
832283|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a norepinephrine infusion.
832284|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of average blood pressure taken at varying tilt angles following a saline infusion.
832285|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of average blood pressure taken at varying tilt angles.
832286|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a norepinephrine infusion.
832287|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of cardiac stroke volume taken at varying tilt angles following a saline infusion.
832288|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of cardiac stroke volume taken at varying tilt angles.
832289|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a norepinephrine infusion.
832290|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of heart rate taken at varying tilt angles following a saline infusion.
832291|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of heart rate taken at varying tilt angles.
832292|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
832293|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
832378|NCT01285518|B5|Baseline|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832294|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure, with baseline measurements of diastolic blood pressure taken at varying tilt angles.
832295|NCT01285908|O3|Outcome|Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a norepinephrine infusion.
832296|NCT01285908|O2|Outcome|Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements of blood pressure taken at varying tilt angles following a saline infusion.
832297|NCT01285908|O1|Outcome|Baseline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of systolic blood pressure taken at varying tilt angles.
832298|NCT01285908|E3|Reported Event|Norepinephrine, Then Saline|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of norepinephrine, followed by IV administration of saline.
832299|NCT01285908|E2|Reported Event|Saline, Then Norepinephrine|The participants are subjects with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with measurements taken at varying tilt angles under two separate conditions, i.e., following IV administration of saline, followed by IV administration of norepinephrine.
832300|NCT01285908|E1|Reported Event|Baseline|The participants are patients with neurogenic orthostatic hypotension associated with Parkinson disease or pure autonomic failure with baseline measurements of BP at varying tilt angles.
832301|NCT01285843|B3|Baseline|Total|Total of all reporting groups
832302|NCT01285843|B2|Baseline|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
832303|NCT01285843|B1|Baseline|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
832304|NCT01285843|P2|Participant Flow|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
832305|NCT01285843|P1|Participant Flow|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
832306|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
832307|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
832308|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
832309|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
832310|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
832311|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
832312|NCT01285843|O2|Outcome|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
832313|NCT01285843|O1|Outcome|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
832314|NCT01285843|E2|Reported Event|AMIStem Group|Patient receiving Amistem H femoral component by anterior Minimally Invasive Approach (AMIS)Anterior Minimally Invasive Approach (AMIS)
832315|NCT01285843|E1|Reported Event|Quadra Group|Patient receiving Quadra femoral component by anterior Minimally Invasive Approach (AMIS)
832316|NCT01285791|B4|Baseline|Total|Total of all reporting groups
832317|NCT01285791|B3|Baseline|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832318|NCT01285791|B2|Baseline|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832319|NCT01285791|B1|Baseline|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
832320|NCT01285791|P3|Participant Flow|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832321|NCT01285791|P2|Participant Flow|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832322|NCT01285791|P1|Participant Flow|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
832323|NCT01285791|O3|Outcome|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832324|NCT01285791|O2|Outcome|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832325|NCT01285791|O1|Outcome|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
832379|NCT01285518|B4|Baseline|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832326|NCT01285791|E3|Reported Event|Patients Undergoing Laparoscopic Gastric Bypass|morbid obese patients undergoing laparoscopic gastric bypass will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832327|NCT01285791|E2|Reported Event|Patients Undergoing Laparoscopic Sleeve Gastrectomy|morbid obese patients undergoing laparoscopic sleeve gastrectomy will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased
832328|NCT01285791|E1|Reported Event|Patients Undergoing Laparoscopic Adjustable Gastric Banding|morbid obese patients undergoing laparoscopic adjustable gastric banding will be evaluated by ultrasound before surgery and one year after surgery to determine the amount of visceral fat layer decreased.
832329|NCT01285713|B3|Baseline|Total|Total of all reporting groups
832330|NCT01285713|B2|Baseline|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
832331|NCT01285713|B1|Baseline|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
832332|NCT01285713|P2|Participant Flow|Normal Saline (NS)|10cc/kg NS, followed by 30cc/kg NS
832333|NCT01285713|P1|Participant Flow|5% Dextrose (D5) in Normal Saline (NS)|10cc/kg D5NS, followed by 30cc/kg NS
832334|NCT01285713|O2|Outcome|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
832335|NCT01285713|O1|Outcome|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
832336|NCT01285713|E2|Reported Event|Normal Saline|10cc/kg NS, followed by 30cc/kg NS
832337|NCT01285713|E1|Reported Event|D5Normal Saline|10cc/kg D5NS, followed by 30cc/kg NS
832338|NCT01285635|B4|Baseline|Total|Total of all reporting groups
832339|NCT01285635|B3|Baseline|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832340|NCT01285635|B2|Baseline|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
832341|NCT01285635|B1|Baseline|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832342|NCT01285635|P3|Participant Flow|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832343|NCT01285635|P2|Participant Flow|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832344|NCT01285635|P1|Participant Flow|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832345|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832346|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832347|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832348|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832349|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832350|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832351|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832352|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles
832353|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832354|NCT01285635|O1|Outcome|Docetaxel and AT-101|"Patients all receive Docetaxel 75mg/m^2 on Day 1. Patients will receive AT-101 on one of the following arms:~Arm A: Docetaxel alone for two weeks, then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.~Arm B: AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles~Arm C: AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles."
832355|NCT01285635|O3|Outcome|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832356|NCT01285635|O2|Outcome|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832357|NCT01285635|O1|Outcome|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832358|NCT01285635|E3|Reported Event|Metronomic AT-101 Arm|AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832359|NCT01285635|E2|Reported Event|Pulse AT-101 Then Metronomic AT-101|AT-101 (40 mg b.i.d. on days 1-3) then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832360|NCT01285635|E1|Reported Event|Docetaxel Then Metronomic AT-101|Docetaxel (75 mg/m2 on Cycle Day 1) for 2 weeks then AT-101 (20mg daily days 1-14) and Docetaxel (75 mg/m2 on Cycle Day 1) for up to 10 cycles.
832361|NCT01285609|B3|Baseline|Total|Total of all reporting groups
832362|NCT01285609|B2|Baseline|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832380|NCT01285518|B3|Baseline|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832363|NCT01285609|B1|Baseline|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832364|NCT01285609|P2|Participant Flow|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemotherapy Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemotherapy Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832365|NCT01285609|P1|Participant Flow|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemotherapy Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832366|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemotherapy Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832367|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemotherapy Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
833038|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
832368|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832369|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832370|NCT01285609|O2|Outcome|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone The blinded therapy (Placebo) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832371|NCT01285609|O1|Outcome|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone The blinded therapy (Ipilimumab) started at the 3rd dose of active chemotherapy backbone (Paclitaxel/Carboplatin).~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Active Chemo Backbone:~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832372|NCT01285609|E2|Reported Event|Placebo With Paclitaxel/Carboplatin|"Placebo + Active Chemo Backbone~Placebo: IV solution, IV, 0.9% sodium chloride or 5% dextrose, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832373|NCT01285609|E1|Reported Event|Ipilimumab With Paclitaxel/Carboplatin|"Ipilimumab + Active Chemo Backbone~Ipilimumab: IV solution, intravenous (IV), 10 mg/kg, 90 minute infusion, Once every 3 weeks for 4 doses and then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)~Paclitaxel: IV solution, IV, 175 mg/m², 3 hour infusion, Once every 3 weeks for 6 doses~Carboplatin: IV solution, IV, Area Under the Curve (AUC) = 6, 30 minute infusion, Once every 3 weeks for 6 doses"
832374|NCT01285518|B9|Baseline|Total|Total of all reporting groups
832375|NCT01285518|B8|Baseline|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832376|NCT01285518|B7|Baseline|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832377|NCT01285518|B6|Baseline|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832382|NCT01285518|B1|Baseline|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832383|NCT01285518|P8|Participant Flow|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832384|NCT01285518|P7|Participant Flow|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832385|NCT01285518|P6|Participant Flow|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832386|NCT01285518|P5|Participant Flow|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832387|NCT01285518|P4|Participant Flow|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832388|NCT01285518|P3|Participant Flow|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832389|NCT01285518|P2|Participant Flow|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832390|NCT01285518|P1|Participant Flow|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832391|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832392|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832393|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832394|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832395|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832396|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832397|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832398|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832399|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832400|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832401|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832402|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832405|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832406|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832407|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832408|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832409|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832410|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832411|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832412|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832413|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832414|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832415|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832416|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832417|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832418|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832419|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832420|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832421|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832422|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832423|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832424|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832425|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832426|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832427|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832428|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832429|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832430|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832431|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832432|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832433|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832434|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832435|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832436|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832437|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832438|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832439|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832440|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832441|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832442|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832443|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832444|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832445|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832446|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832447|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832448|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832449|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832450|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832451|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832452|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832453|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
833039|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
832454|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832455|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832456|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832457|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832458|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832459|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832460|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832461|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832462|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832463|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832464|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832465|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832466|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832467|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832468|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832469|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832470|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832471|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832472|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832473|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832474|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832475|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832476|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832477|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832478|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832479|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832480|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832481|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832482|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832483|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832484|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832485|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832486|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832487|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832488|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832489|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832490|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832491|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832492|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832493|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832494|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832495|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832496|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832497|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832498|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832499|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832500|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832501|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832502|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832503|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832504|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832505|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832506|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832507|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832508|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832509|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832510|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832511|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832512|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832513|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832514|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832515|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832516|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832517|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832518|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832519|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832520|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832521|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832522|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832523|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832524|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832525|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832526|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832527|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832528|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832529|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832530|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832531|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832532|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832533|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832534|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832535|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832536|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832537|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832538|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832539|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832540|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832541|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832542|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832543|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832544|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832545|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832546|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832547|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832548|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832549|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832550|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832551|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832552|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832553|NCT01285518|O1|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832554|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832555|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832556|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832557|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832558|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832559|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832560|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832561|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832562|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832563|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832564|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832565|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832566|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832567|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832568|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832569|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832570|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832571|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832572|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832573|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832574|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832575|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
833513|NCT01283516|B2|Baseline|100 mg|Participants receiving 100 mg of LDK378
832576|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832577|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832578|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832579|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832580|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832581|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832582|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832583|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832584|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832585|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832586|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832587|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832588|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832589|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832590|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832591|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832592|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832593|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832594|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832595|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832596|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832597|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832598|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832599|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832600|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832601|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832602|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832603|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832604|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832605|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832606|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832607|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832608|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832609|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832610|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832611|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832612|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832613|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832614|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832615|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832616|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832617|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832618|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832619|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832620|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832621|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832622|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832623|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832624|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832625|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832626|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832627|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832628|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832629|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832630|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832631|NCT01285518|O8|Outcome|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832632|NCT01285518|O7|Outcome|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832633|NCT01285518|O6|Outcome|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832634|NCT01285518|O5|Outcome|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832635|NCT01285518|O4|Outcome|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832636|NCT01285518|O3|Outcome|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832637|NCT01285518|O2|Outcome|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832638|NCT01285518|O1|Outcome|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832639|NCT01285518|E8|Reported Event|Placebo|Single dose of placebo matched to either intravenous bolus injection or intravenous infusion over approximately 1 hour on Day 1.
832640|NCT01285518|E7|Reported Event|PF-05231023 200 mg|Single dose of PF-05231023 200 mg intravenous infusion over approximately 1 hour on Day 1.
832641|NCT01285518|E6|Reported Event|PF-05231023 100 mg|Single dose of PF-05231023 100 mg intravenous infusion over approximately 1 hour on Day 1.
832642|NCT01285518|E5|Reported Event|PF-05231023 50 mg|Single dose of PF-05231023 50 mg intravenous infusion over approximately 1 hour on Day 1.
832643|NCT01285518|E4|Reported Event|PF-05231023 15 mg|Single dose of PF-05231023 15 mg intravenous infusion over approximately 1 hour on Day 1.
832644|NCT01285518|E3|Reported Event|PF-05231023 5 mg|Single dose of PF-05231023 5 mg intravenous infusion over approximately 1 hour on Day 1.
832645|NCT01285518|E2|Reported Event|PF-05231023 1.5 mg|Single dose of PF-05231023 1.5 mg, intravenous bolus injection on Day 1.
832646|NCT01285518|E1|Reported Event|PF-05231023 0.5 mg|Single dose of PF-05231023 0.5 milligram (mg) intravenous bolus injection on Day 1.
832647|NCT01285492|B3|Baseline|Total|Total of all reporting groups
832648|NCT01285492|B2|Baseline|Tiotropium|tiotropium 18 μg o.d.
832649|NCT01285492|B1|Baseline|QVA149|QVA149 110/50 μg once a day (o.d)
832650|NCT01285492|P2|Participant Flow|Tiotropium|tiotropium 18 μg o.d.
832651|NCT01285492|P1|Participant Flow|QVA149|QVA149 110/50 μg o.d. (once a day)
832652|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
832653|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
832654|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
832655|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
832656|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
832657|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
832658|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
832659|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
832660|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
832661|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
832662|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
832663|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
832664|NCT01285492|O2|Outcome|Tiotropium|tiotropium 18 μg o.d.
832665|NCT01285492|O1|Outcome|QVA149|QVA149 110/50 μg once a day (o.d)
832666|NCT01285492|E2|Reported Event|Tiotropium|tiotropium 18 μg o.d.
832667|NCT01285492|E1|Reported Event|QVA149|QVA149 110/50 μg once a day (o.d)
832668|NCT01285427|B1|Baseline|DNA Loci (SeCore vs. SSP UniTray Platforms)|
832669|NCT01285427|P1|Participant Flow|DNA Loci (SeCore vs. SSP UniTray Platforms)|
832670|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB345 Loci)|SeCore® Kit, DR Group Kit (DRB345 Loci),
832671|NCT01285427|O1|Outcome|SeCore® Kit, DR Group Kit (DRB1 Locus)|SeCore® Kit, DR Group Kit (DRB1 Locus),
832672|NCT01285427|O1|Outcome|SeCore® Kit, DRB1 Locus|SeCore® Kit, DRB1 Locus
832673|NCT01285427|O1|Outcome|SeCore® Kit, DQB1 Locus|SeCore® Kit, DQB1 Locus
832674|NCT01285427|O1|Outcome|SeCore® DPB1 Locus Kit|SeCore® DPB1 Locus Kit
832675|NCT01285427|O1|Outcome|SeCore® Kit, C Locus|SeCore® Kit, C Locus
832676|NCT01285427|O1|Outcome|SeCore® Kit, B Locus (Single Amp)|SeCore® Kit, B Locus (Single Amp)
832677|NCT01285427|O1|Outcome|Concordance|SeCore kit, A Locus
832678|NCT01285427|O1|Outcome|Concordance|All SeCore Kits
832679|NCT01285427|E1|Reported Event|Concordance|All SeCore Kits
832680|NCT01285401|B3|Baseline|Total|Total of all reporting groups
832681|NCT01285401|B2|Baseline|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832682|NCT01285401|B1|Baseline|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832683|NCT01285401|P2|Participant Flow|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832684|NCT01285401|P1|Participant Flow|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25-hydroxyvitamin D [25(OH)D3] serum levels below 150 nano mol per liter (nmol/L) received Vigantol oil 6,670 international unit per day (IU/d) [167 microgram per day (mcg/d)] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous three times a week (tiw).
832685|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832686|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832687|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832688|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832689|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832690|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832691|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832692|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832693|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832694|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832695|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832727|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832696|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832697|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832698|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832699|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832700|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832701|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832702|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832703|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832704|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832705|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832706|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832707|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832708|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832709|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832710|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832711|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832712|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832713|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832714|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832715|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832716|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832717|NCT01285401|O2|Outcome|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832718|NCT01285401|O1|Outcome|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832719|NCT01285401|E2|Reported Event|Placebo Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L, received matching placebo for 48 weeks on top of Rebif 44 mcg administered subcutaneous tiw.
832720|NCT01285401|E1|Reported Event|VigantOL Oil Interferon Beta-1a (Rebif)|Subjects with 25(OH)D3 serum levels below 150 nmol/L received Vigantol oil 6,670 IU/d [167 mcg/d] orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) for 44 weeks along with of Rebif 44 mcg administered subcutaneous tiw.
832721|NCT01285323|B3|Baseline|Total|Total of all reporting groups
832722|NCT01285323|B2|Baseline|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832723|NCT01285323|B1|Baseline|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832724|NCT01285323|P2|Participant Flow|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832725|NCT01285323|P1|Participant Flow|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832726|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832728|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832729|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832730|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832731|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832732|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832733|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832734|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832735|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832736|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832737|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832738|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832739|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832740|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832741|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832742|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832743|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832744|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832745|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832746|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832747|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832748|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832749|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832750|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832751|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832752|NCT01285323|O2|Outcome|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832753|NCT01285323|O1|Outcome|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832754|NCT01285323|E2|Reported Event|Reslizumab 3.0 mg/kg|Reslizumab 3.0 mg/kg administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832755|NCT01285323|E1|Reported Event|Placebo|Placebo administered intravenously once every 4 weeks ( +-7 days) for a total of 13 doses.
832756|NCT01285310|B4|Baseline|Total|Total of all reporting groups
832757|NCT01285310|B3|Baseline|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832758|NCT01285310|B2|Baseline|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase and continued 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832759|NCT01285310|B1|Baseline|Placebo|Placebo: Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders were transitioned early to 20 mg Apremilast BID at Week 16.
832760|NCT01285310|P5|Participant Flow|Placebo / Apremilast 20 mg XO|"Participants initially randomized to receive placebo twice daily who were transitioned at Week 24 (XO) to receive 20 mg apremilast for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
832761|NCT01285310|P4|Participant Flow|Placebo/Apremilast 20mg EE|"Participants initially randomized to receive placebo twice daily and were transitioned due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to week 24.~At week 24, participants were continued on Apremilast 20 mg BID for up to Week 52.~At week 52, they were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
832762|NCT01285310|P3|Participant Flow|Apremilast 30 mg|"Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
832763|NCT01285310|P2|Participant Flow|Apremilast 20 mg|"Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily (BID) for up to Week 52 in the active treatment.~At week 52, participants were given the option to remain on active treatment for 1 additional year (extension phase) as assigned during the active treatment phase."
832788|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832764|NCT01285310|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg Apremilast twice daily (early escape), and were designated as Placebo/Apremilast 20mg EE.
832765|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832766|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832767|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832768|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832769|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832770|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832771|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832772|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832773|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832774|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832775|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832776|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832811|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832777|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832778|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832779|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832780|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832781|NCT01285310|O2|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832782|NCT01285310|O1|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832783|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832784|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832785|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832786|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832787|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
833040|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
832789|NCT01285310|O2|Outcome|Apremilast 30 mg|Apremilast 30 mg: 30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832790|NCT01285310|O1|Outcome|Apremilast 20 mg|Apremilast 20 mg: 20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
832791|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832792|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832793|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832794|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832795|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832796|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832797|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832798|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832799|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832800|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832801|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832802|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832803|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832804|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832805|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|.Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832806|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832807|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832808|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832809|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily
832810|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832812|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832813|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832814|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832815|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832816|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832817|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832818|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832819|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832820|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832821|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832822|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832823|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832824|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832825|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832826|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832827|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832828|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832829|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832830|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
833041|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
832831|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832832|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832833|NCT01285310|O2|Outcome|Placebo / Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832834|NCT01285310|O1|Outcome|Placebo/Apremilast 20 EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832835|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832836|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832837|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832838|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832839|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832840|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832841|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832842|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832843|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832844|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832845|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832846|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832847|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832848|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832849|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832850|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832851|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832852|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832853|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832854|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832855|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832856|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832857|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832858|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832859|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832860|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832861|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832862|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832863|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832864|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832865|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned transitioned to receive 20 mg apremilast twice daily.
832866|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832867|NCT01285310|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832868|NCT01285310|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832869|NCT01285310|O2|Outcome|Placebo/Apremilast 20 mg XO|Participants who received placebo twice daily up to Week 24 and were then transitioned to receive 20 mg apremilast twice daily.
832870|NCT01285310|O1|Outcome|Placebo/Apremilast 20mg EE|Participants who received placebo twice daily up to Week 16 and were then transitioned to receive 20 mg apremilast twice daily.
832871|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832872|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832953|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832954|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832873|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832874|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832875|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832876|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832877|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832878|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832879|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832880|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832881|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832882|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned to 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832883|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832884|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832885|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832886|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832887|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832888|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832889|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832890|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832891|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape)and were designated as Placebo/Apremilast 20mg EE.
832892|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832893|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832894|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832895|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832896|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832897|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832898|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832899|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832900|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832901|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832902|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832903|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832904|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832905|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832906|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832907|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832908|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832909|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE .
832910|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832911|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832912|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832913|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832914|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832915|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832916|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832917|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832918|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE ..
832919|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832920|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832921|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832922|NCT01285310|O3|Outcome|Apremilast 30 mg|.Participants initially randomized to receive 30 mg apremilast tablets twice daily
832923|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832924|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832925|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832926|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily
832927|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape).
832928|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832929|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832930|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832931|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832932|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832933|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832934|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832935|NCT01285310|O2|Outcome|Apremilast 20 mg|.Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832936|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832937|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832938|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832939|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832940|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832941|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832942|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily
832943|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832944|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832945|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832946|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832947|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832948|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832949|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832950|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832951|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832952|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832955|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832956|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832957|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832958|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832959|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832960|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832961|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832962|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832963|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832964|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832965|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832966|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832967|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily..
832968|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832969|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832970|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832971|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832972|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832973|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832974|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832975|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832976|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832977|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832978|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832979|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832980|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832981|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE
832982|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily
832983|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily
832984|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were transitioned onto 20 mg apremilast twice daily (early escape) and were designated as Placebo/Apremilast 20mg EE.
832985|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832986|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832987|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832988|NCT01285310|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
832989|NCT01285310|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
832990|NCT01285310|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
832991|NCT01285310|E5|Reported Event|Study Termination: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
832992|NCT01285310|E4|Reported Event|Study Termination: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Study Termination.
832993|NCT01285310|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
832994|NCT01285310|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
832995|NCT01285310|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
832996|NCT01285076|B1|Baseline|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
832997|NCT01285076|P1|Participant Flow|All Enrolled Participants|Adults with Type 2 diabetes mellitus (DM) ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU + metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
832998|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833042|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
832999|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833000|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833001|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833002|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833003|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833004|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833005|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833006|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833007|NCT01285076|O1|Outcome|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833008|NCT01285076|E1|Reported Event|All Enrolled Participants|Adults with Type 2 DM ≥30 years of age who have been treated with SU monotherapy or SU + MF combination therapy for at least 6 months by a cardiologist, nephrologist, neurologist, or family practice doctor.
833009|NCT01285050|B1|Baseline|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
833010|NCT01285050|P1|Participant Flow|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
833011|NCT01285050|O2|Outcome|Post ART HCV Decline|HCV RNA determined by RT-PCR and expressed as log IU/ml after ART
833062|NCT01284634|P3|Participant Flow|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833012|NCT01285050|O1|Outcome|Pre ART HCV RNA Decline|"HCV viral load determined by RT-PCR and reported as log IU/ml before giving antiretroviral therapy (ART)~Interferon alfa-2b was administered once as part of a pharmacokinetic study before and after ART.~ART included:~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
833013|NCT01285050|E1|Reported Event|Pre Post ART|"HCV and HIV viral load pre and post antiretroviral therapy~Anti-HIV Agents: Interferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications.~raltegravir: HIV medication, 400 mg twice daily by mouth~Emtricitabine and tenofovir disoproxil fumarate: HIV medication, combination pill, once per day by mouth"
833014|NCT01285024|B3|Baseline|Total|Total of all reporting groups
833015|NCT01285024|B2|Baseline|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
833016|NCT01285024|B1|Baseline|Control|No Vitagel used during total hip arthroplasty
833017|NCT01285024|P2|Participant Flow|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
833018|NCT01285024|P1|Participant Flow|Control|No Vitagel used during total hip arthroplasty
833019|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
833020|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
833021|NCT01285024|O2|Outcome|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
833022|NCT01285024|O1|Outcome|Control|No Vitagel used during total hip arthroplasty
833023|NCT01285024|E2|Reported Event|Vitagel|"Vitagel applied just prior to closure during total hip arthroplasty~Vitagel: Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule."
833024|NCT01285024|E1|Reported Event|Control|No Vitagel used during total hip arthroplasty
833025|NCT01284959|B4|Baseline|Total|Total of all reporting groups
833026|NCT01284959|B3|Baseline|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
833027|NCT01284959|B2|Baseline|Placebo|drug: lactose group: placebo
833028|NCT01284959|B1|Baseline|Risperidone|Drug: risperidone Groups: risperidone
833029|NCT01284959|P3|Participant Flow|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
833030|NCT01284959|P2|Participant Flow|Placebo|drug: lactose group: placebo
833031|NCT01284959|P1|Participant Flow|Risperidone|Drug: risperidone Groups: risperidone
833032|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
833033|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
833043|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
833044|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
833045|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
833046|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
833047|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
833048|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
833049|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
833050|NCT01284959|O3|Outcome|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
833051|NCT01284959|O2|Outcome|Placebo|drug: lactose group: placebo
833052|NCT01284959|O1|Outcome|Risperidone|Drug: risperidone Groups: risperidone
833053|NCT01284959|E3|Reported Event|Paliperidone ER|Drug: Paliperidone ER Groups: Paliperidone ER
833054|NCT01284959|E2|Reported Event|Placebo|drug: lactose group: placebo
833055|NCT01284959|E1|Reported Event|Risperidone|Drug: risperidone Groups: risperidone
833056|NCT01284634|B5|Baseline|Total|Total of all reporting groups
833057|NCT01284634|B4|Baseline|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833058|NCT01284634|B3|Baseline|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
833059|NCT01284634|B2|Baseline|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
833060|NCT01284634|B1|Baseline|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes for the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
833061|NCT01284634|P4|Participant Flow|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833063|NCT01284634|P2|Participant Flow|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833064|NCT01284634|P1|Participant Flow|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833065|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833066|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833067|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833068|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833069|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833070|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833071|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833072|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833073|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833074|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833075|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833076|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833077|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833078|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833079|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833080|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833081|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833082|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833083|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833084|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833268|NCT01284504|P2|Participant Flow|Placebo|"placebo~placebo"
833269|NCT01284504|P1|Participant Flow|Celocoxib|Celecoxib: 200 mg tablet oral
833085|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833086|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833087|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833088|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833089|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833090|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833091|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833092|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833093|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833094|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833095|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833096|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833119|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833097|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833098|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833099|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833100|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833101|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833102|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833103|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833104|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833105|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833106|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833270|NCT01284504|O2|Outcome|Placebo|"placebo~placebo"
833107|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833108|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833109|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833110|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833111|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833112|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833113|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833114|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833115|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833116|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833117|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833118|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833120|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833121|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833122|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833123|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833124|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833125|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833126|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833127|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833128|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833271|NCT01284504|O1|Outcome|Celocoxib|Celecoxib: 200 mg tablet oral
833272|NCT01284504|E2|Reported Event|Placebo|"placebo, tab~placebo: Placebo, tab"
833129|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833130|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833131|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833132|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833133|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833134|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833135|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833136|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833137|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833138|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833139|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833140|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833163|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833141|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833142|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833143|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833144|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833145|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833146|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833147|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833148|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833149|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833150|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833273|NCT01284504|E1|Reported Event|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
833151|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833152|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833153|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833154|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833155|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833156|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833157|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833158|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833159|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833160|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833161|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833162|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833164|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833165|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833166|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833167|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833168|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833169|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833170|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833171|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833172|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833274|NCT01284491|B1|Baseline|Total Study Population|
833275|NCT01284491|P1|Participant Flow|Total Study Population|
833173|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833174|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833175|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 .
833176|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833177|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833178|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833179|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833180|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833181|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833182|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833183|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833184|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833207|NCT01284621|P5|Participant Flow|Empa + Ramipril / Empa Alone / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Empagliflozin alone~Ramipril"
833483|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833185|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833186|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833187|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833188|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833189|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833190|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833191|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833192|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833193|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833194|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 .
833514|NCT01283516|B1|Baseline|50 mg|Participants receiving 50 mg of LDK378
833195|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833196|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833197|NCT01284634|O4|Outcome|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833198|NCT01284634|O3|Outcome|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003.
833199|NCT01284634|O2|Outcome|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003.
833200|NCT01284634|O1|Outcome|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003.
833201|NCT01284634|E4|Reported Event|Placebo|Placebo capsules were presented as Licaps® size double zero (Size 00) hard gelatin capsules containing excipients (Gelucire 44/14). Each capsule exactly matched the GWP42003 capsules in terms of appearance, size, smell and taste. Subjects self-administered one, two or four placebo capsules twice daily, according to the same regimen as active treatment.
833202|NCT01284634|E3|Reported Event|800 mg GWP42003|Subjects self-administered four x 100 mg GWP42003 capsule twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 800 mg GWP42003 per day.
833203|NCT01284634|E2|Reported Event|400 mg GWP42003|Subjects self-administered two x 100 mg GWP42003 capsules twice daily (the first dose was 30 minutes before breakfast [fasted] and the second was 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 400 mg GWP42003 per day.
833204|NCT01284634|E1|Reported Event|200 mg GWP42003|Subjects self-administered one x 100 mg GWP42003 capsule twice daily (the first 30 minutes before breakfast [fasted] and the second 30 minutes before the evening meal [typically 12 hours apart]). This gave a total daily dose of 200 mg GWP42003 per day.
833205|NCT01284621|B1|Baseline|Study Overall|"A randomised, open-label, three period, crossover study. The three treatments administered were~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril~Each treatment period was 8 days, with drug administration on days 1 to 5, and they were separated by a washout period of at least 7 days between drug administrations of 2 subsequent treatments."
833206|NCT01284621|P6|Participant Flow|Empa + Ramipril / Ramipril Alone / Empa Alone|"Patients were administered three treatments in the following order:~Empagliflozin plus Ramipril~Ramipril~Empagliflozin alone"
833208|NCT01284621|P4|Participant Flow|Ramipril Alone / Empa + Ramipril / Empa Alone|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin plus Ramipril~Empagliflozin alone"
833209|NCT01284621|P3|Participant Flow|Ramipril Alone / Empa Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Ramipril~Empagliflozin alone~Empagliflozin plus Ramipril"
833210|NCT01284621|P2|Participant Flow|Empa Alone / Ramipril Alone / Empa + Ramipril|"Patients were administered three treatments in the following order:~Empagliflozin alone~Ramipril~Empagliflozin plus Ramipril"
833211|NCT01284621|P1|Participant Flow|Empa Alone / Empa + Ramipril / Ramipril Alone|"Patients were administered three treatments in the following order:~Empagliflozin alone~Empagliflozin plus Ramipril~Ramipril"
833212|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833213|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833214|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833215|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833216|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833217|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833218|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833219|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833220|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833221|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833222|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833223|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833276|NCT01284491|O2|Outcome|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
833224|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833225|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833226|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833227|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833228|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833229|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833230|NCT01284621|O3|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833231|NCT01284621|O2|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833232|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833233|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833234|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833235|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833236|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833237|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833238|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833239|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833240|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833241|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833242|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833243|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833244|NCT01284621|O1|Outcome|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833245|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833246|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833247|NCT01284621|O2|Outcome|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833248|NCT01284621|O1|Outcome|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833249|NCT01284621|E3|Reported Event|Empa + Ramipril|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5. A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833250|NCT01284621|E2|Reported Event|Ramipril Alone|A single dose of ramipril 2.5mg was administered on day 1. Ramipril 5mg was administered once daily from day 2 to day 5.
833251|NCT01284621|E1|Reported Event|Empa Alone|Empagliflozin 25mg (Empa) was administered once daily from day 1 to day 5.
833252|NCT01284517|B3|Baseline|Total|Total of all reporting groups
833253|NCT01284517|B2|Baseline|Placebo + Li/VPA|
833254|NCT01284517|B1|Baseline|Lurasidone 20-120 mg Flexible Dose+Li/VPA|
833255|NCT01284517|P2|Participant Flow|Placebo + Li/VPA|Placebo + Lithium/divalproex
833256|NCT01284517|P1|Participant Flow|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
833257|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
833258|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
833259|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
833260|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
833261|NCT01284517|O2|Outcome|Placebo + Li/VPA|Placebo (PO) + Lithium or divalproex
833262|NCT01284517|O1|Outcome|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
833263|NCT01284517|E2|Reported Event|Placebo + Li/VPA|Placebo (PO)+ Lithium/divalproex
833264|NCT01284517|E1|Reported Event|Lurasidone 20-120 mg Flexible Dose+Li/VPA|Lurasidone 20-120 mg/day (PO) flexibly dosed+Lithium/divalproex
833265|NCT01284504|B3|Baseline|Total|Total of all reporting groups
833266|NCT01284504|B2|Baseline|Placebo|"placebo, tab~placebo: Placebo, tab"
833267|NCT01284504|B1|Baseline|Celecoxib|"Celecoxib, 200 mg tab~Celecoxib: 200 mg tablet oral"
833277|NCT01284491|O1|Outcome|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
833278|NCT01284491|E2|Reported Event|Traditional Electrosurgery With Scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
833279|NCT01284491|E1|Reported Event|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
833280|NCT01284426|B1|Baseline|Chronic Urticaria|Chronic urticaria, Natural history
833281|NCT01284426|P1|Participant Flow|Chronic Urticaria|Chronic urticaria, Natural history
833282|NCT01284426|O1|Outcome|Chronic Urticaria|Chronic urticaria, Natural history
833283|NCT01284426|E1|Reported Event|Chronic Urticaria|Chronic urticaria, Natural history
833284|NCT01284361|B1|Baseline|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
833285|NCT01284361|P1|Participant Flow|Control and Test Crossover|test and control intermittent urinary catheters : randomized cross-over
833286|NCT01284361|O2|Outcome|Test 30 cm Catheter|Test gel lubricated 30 cm catheter identical in all aspects to Control catheter except being 10 cm shorter
833287|NCT01284361|O1|Outcome|Control 40 cm Catheter|Commercial gel lubricated 40 cm catheter
833288|NCT01284361|O1|Outcome|Control and Test Crossover|Control and test intermittent urinary catheters : randomized cross-over
833289|NCT01284361|E2|Reported Event|Test 30 cm Catheter|Test 30 cm gel lubricated cather similar in all aspects except 10 cm shorter length as control catheter
833290|NCT01284361|E1|Reported Event|Control 40 cm Catheter|Commercial 40 cm gel lubricated catheter
833291|NCT01284296|B1|Baseline|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
833292|NCT01284296|P1|Participant Flow|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
833293|NCT01284296|O2|Outcome|Digital Block (Perfusion Indices >2.0)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss. This is a subgroup of differences with the perfusion index >2.0
833294|NCT01284296|O1|Outcome|Digital Block (All Perfusion Indices 0.29-8.3)|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
833295|NCT01284296|E1|Reported Event|Digital Block|The difference between intermittent readings of the SpHb continuous hemoglobin monitor with the digital lidocaine block and a laboratory hemoglobin were evaluated for patients undergoing spine surgery and blood loss.
833296|NCT01284244|B3|Baseline|Total|Total of all reporting groups
833297|NCT01284244|B2|Baseline|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
835233|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
833298|NCT01284244|B1|Baseline|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
833299|NCT01284244|P2|Participant Flow|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
833300|NCT01284244|P1|Participant Flow|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
833301|NCT01284244|O2|Outcome|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
833340|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833341|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833342|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833343|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833515|NCT01283516|P9|Participant Flow|750 mg|Participants receiving 750 mg of LDK378
833302|NCT01284244|O1|Outcome|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
833303|NCT01284244|E2|Reported Event|Silastic Vaginal Ring|Silastic ring: The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
833304|NCT01284244|E1|Reported Event|Uresta|Uresta pessary: Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
833305|NCT01284114|B1|Baseline|Aliskiren|
833306|NCT01284114|P1|Participant Flow|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
833307|NCT01284114|O1|Outcome|Aliskiren|
833308|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
833309|NCT01284114|O1|Outcome|Aliskiren|Aliskiren: This group recived aliskiren at 150mg orally in the morning once daily
833310|NCT01284114|O1|Outcome|Aliskiren|
833311|NCT01284114|O1|Outcome|Aliskiren|
833312|NCT01284114|E1|Reported Event|Aliskiren|
833313|NCT01284062|B5|Baseline|Total|Total of all reporting groups
833314|NCT01284062|B4|Baseline|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833315|NCT01284062|B3|Baseline|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833316|NCT01284062|B2|Baseline|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833317|NCT01284062|B1|Baseline|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833318|NCT01284062|P4|Participant Flow|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833319|NCT01284062|P3|Participant Flow|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833320|NCT01284062|P2|Participant Flow|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833321|NCT01284062|P1|Participant Flow|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833322|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833323|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833324|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833325|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833326|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833327|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833328|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833329|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833330|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833331|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833332|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833333|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833334|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833335|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833336|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833337|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833338|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833339|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833344|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833345|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833346|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833347|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833348|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833349|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833350|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833351|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833352|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833353|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833354|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833355|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833356|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833357|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833358|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833359|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833360|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833361|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833362|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833363|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833364|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833365|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833366|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
835546|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
833367|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833368|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833369|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833370|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833371|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833372|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833373|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833374|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833375|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833376|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833377|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833378|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833379|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833380|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833381|NCT01284062|O3|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833382|NCT01284062|O2|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833383|NCT01284062|O1|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833384|NCT01284062|O4|Outcome|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833385|NCT01284062|O3|Outcome|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833386|NCT01284062|O2|Outcome|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833387|NCT01284062|O1|Outcome|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833453|NCT01283581|O2|Outcome|Linezolid|Linezolid 600 mg, BID
833388|NCT01284062|E4|Reported Event|Anrukinzumab 600 mg|Anrukinzumab (PF-05230917) 600 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833389|NCT01284062|E3|Reported Event|Anrukinzumab 400 mg|Anrukinzumab (PF-05230917) 400 mg intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833390|NCT01284062|E2|Reported Event|Anrukinzumab 200 mg|Anrukinzumab (PF-05230917) 200 milligram (mg) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833391|NCT01284062|E1|Reported Event|Placebo|Placebo matched to anrukinzumab (PF-05230917) intravenous infusion over 1 hour on Day 1, Week 2, 4, 8 and 12.
833392|NCT01283971|B3|Baseline|Total|Total of all reporting groups
833393|NCT01283971|B2|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833394|NCT01283971|B1|Baseline|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833395|NCT01283971|P2|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833396|NCT01283971|P1|Participant Flow|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833397|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833398|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833399|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833400|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833401|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833402|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833403|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833404|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833405|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833406|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833407|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833408|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833409|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833410|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833411|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833412|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833413|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833414|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833415|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833416|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833417|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833418|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833419|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833420|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833421|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833422|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833423|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833424|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833425|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833426|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833427|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833428|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833429|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833430|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833431|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833432|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833433|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833434|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833435|NCT01283971|O2|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833436|NCT01283971|O1|Outcome|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833437|NCT01283971|E2|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) every 4 weeks + Placebo to adalimumab subcutaneous (SC) every 2 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833438|NCT01283971|E1|Reported Event|Adalimumab + Methotrexate|Adalimumab 40 mg SC every 2 weeks + Placebo to tocilizumab IV every 4 weeks for 24 weeks. All participants received methotrexate 10-25 mg and folate at least 5 mg/kg weekly.
833439|NCT01282866|B1|Baseline|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
833440|NCT01282866|P1|Participant Flow|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm^2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
833441|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
833442|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
833443|NCT01282866|O1|Outcome|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
833444|NCT01282866|E1|Reported Event|HS Treatment|"Treatment with the LightSheer Duet laser HS handpiece:~Treatment parameters: Fluence: 9-12J/cm2, pulse duration: 30 to 70ms,medium to low vacuum levels.~All patients were treated in the Axilla area."
833445|NCT01283581|B4|Baseline|Total|Total of all reporting groups
833446|NCT01283581|B3|Baseline|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
833447|NCT01283581|B2|Baseline|Linezolid|Linezolid 600 mg, BID
833448|NCT01283581|B1|Baseline|Delafloxacin IV|Delafloxacin 300 mg, BID
833449|NCT01283581|P3|Participant Flow|Vancomycin IV|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
833450|NCT01283581|P2|Participant Flow|Linezolid IV|Linezolid 600 mg, BID
833451|NCT01283581|P1|Participant Flow|Delafloxacin IV|Delafloxacin 300 mg, BID
833452|NCT01283581|O3|Outcome|Vancomycin|Vancomycin 15 mg/kg or up to 1250 mg/dose, BID
833461|NCT01283555|B1|Baseline|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
833462|NCT01283555|P2|Participant Flow|Prefilled Applicator First, Then User-filled|Plastic applicator (prefilled with Tenofovir 1% gel) used twice daily in first intervention period and user-filled applicator used twice daily in second intervention period (after washout period)
833463|NCT01283555|P1|Participant Flow|User-Filled Applicator First, Then Prefilled|User-filled paper applicator (filled using a tube of Tenofovir 1% gel)used twice daily in first intervention period and prefilled applicator used twice daily in second intervention period (after washout period)
833464|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
833465|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
833466|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
833467|NCT01283555|O2|Outcome|Colposcopic Findings After 7 Days of Product Use|Number of colposcopic findings identified during colposcopy after one week of twice daily product use (data from both study arms are combined). Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
833468|NCT01283555|O1|Outcome|Baseline Colposcopic Findings|Number of colposcopic findings identified during baseline colposcopies for both study arms. Note: Since a participant can have more than one colposcopic finding, the number of colposcopic findings does not necessarily equal the number of participants with colposcopic findings.
833469|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
833470|NCT01283555|O1|Outcome|Entire Study Population|Includes groups randomized to use the prefilled applicator first and the user-filled applicator first.
833471|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833472|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833473|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833474|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833475|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833476|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833477|NCT01283555|O3|Outcome|Same|no preference between user-filled or prefilled applicator
833478|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833479|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833480|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833481|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833482|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833484|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833485|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833486|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833487|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833488|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833489|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833490|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833491|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833492|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833493|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833494|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833495|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833496|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833497|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833498|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833499|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833500|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833501|NCT01283555|O2|Outcome|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833502|NCT01283555|O1|Outcome|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833503|NCT01283555|E2|Reported Event|Prefilled Applicator|plastic applicator (prefilled with Tenofovir 1% gel)
833504|NCT01283555|E1|Reported Event|User-Filled Applicator|paper applicator (filled using a tube of Tenofovir 1% gel)
833505|NCT01283516|B10|Baseline|Total|Total of all reporting groups
833506|NCT01283516|B9|Baseline|750 mg|Participants receiving 750 mg of LDK378
833507|NCT01283516|B8|Baseline|700 mg|Participants receiving 700 mg of LDK378
833508|NCT01283516|B7|Baseline|600 mg|Participants receiving 600 mg of LDK378
833509|NCT01283516|B6|Baseline|500 mg|Participants receiving 500 mg of LDK378
833510|NCT01283516|B5|Baseline|400 mg|Participants receiving 400 mg of LDK378
833511|NCT01283516|B4|Baseline|300 mg|Participants receiving 300 mg of LDK378
833512|NCT01283516|B3|Baseline|200 mg|Participants receiving 200 mg of LDK378
833516|NCT01283516|P8|Participant Flow|700 mg|Participants receiving 700 mg of LDK378
833517|NCT01283516|P7|Participant Flow|600 mg|Participants receiving 600 mg of LDK378
833518|NCT01283516|P6|Participant Flow|500 mg|Participants receiving 500 mg of LDK378
833519|NCT01283516|P5|Participant Flow|400 mg|Participants receiving 400 mg of LDK378
833520|NCT01283516|P4|Participant Flow|300 mg|Participants receiving 300 mg of LDK378
833521|NCT01283516|P3|Participant Flow|200 mg|Participants receiving 200 mg of LDK378
833522|NCT01283516|P2|Participant Flow|100 mg|Participants receiving 100 mg of LDK378
833523|NCT01283516|P1|Participant Flow|50 mg|Participants receiving 50 mg of LDK378
833524|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
833525|NCT01283516|O1|Outcome|NSCLC With Prior Crizotinib|NSCLC patients who received prior crizotinib in the 750 mg dose group.
833526|NCT01283516|O9|Outcome|LDK378 750|Participants receiving 750 mg of LDK378.
833527|NCT01283516|O8|Outcome|LDK378 700 mg|Participants receiving 700 mg of LDK378
833528|NCT01283516|O7|Outcome|LDK378 600 mg|Participants receiving 600 mg of LDK378
833529|NCT01283516|O6|Outcome|LDK378 500 mg|Participants receiving 500 mg of LDK378
833530|NCT01283516|O5|Outcome|LDK378 400 mg|Participants receiving 400 mg of LDK378
833531|NCT01283516|O4|Outcome|LDK378 300 mg|Participants receiving 300 mg of LDK378
833532|NCT01283516|O3|Outcome|LDK378 200 mg|Participants receiving 200 mg of LDK378
833533|NCT01283516|O2|Outcome|LDK378 100 mg|Participants receiving 100 mg of LDK378
833534|NCT01283516|O1|Outcome|LDK378 50 mg|Participants receiving 50 mg of LDK378
833535|NCT01283516|E9|Reported Event|LDK378 750 mg|LDK378 750 mg
833536|NCT01283516|E8|Reported Event|LDK378 700 mg|LDK378 700 mg
833537|NCT01283516|E7|Reported Event|LDK378 600 mg|LDK378 600 mg
833538|NCT01283516|E6|Reported Event|LDK378 500 mg|LDK378 500 mg
833539|NCT01283516|E5|Reported Event|LDK378 400 mg|LDK378 400 mg
833540|NCT01283516|E4|Reported Event|LDK378 300 mg|LDK378 300 mg
833541|NCT01283516|E3|Reported Event|LDK378 200 mg|LDK378 200 mg
833542|NCT01283516|E2|Reported Event|LDK378 100 mg|LDK378 100 mg
833543|NCT01283516|E1|Reported Event|LDK378 50 mg|LDK378 50 mg
833544|NCT01283464|B3|Baseline|Total|Total of all reporting groups
833545|NCT01283464|B2|Baseline|Tretinoin|Tretinoin 0.02% cream
833546|NCT01283464|B1|Baseline|Retinol|Retinol 1.0% cream
833547|NCT01283464|P2|Participant Flow|Tretinoin|Tretinoin 0.02% cream to entire face daily or as tolerated for 6 months
833548|NCT01283464|P1|Participant Flow|Retinol|Retinol 1.0% cream to entire face daily or as tolerated for 6 months
833549|NCT01283464|O2|Outcome|Tretinoin|Tretinoin 0.02% cream
833550|NCT01283464|O1|Outcome|Retinol|Retinol 1.0% cream
833551|NCT01283464|E2|Reported Event|Tretinoin|Tretinoin 0.02% cream
833552|NCT01283464|E1|Reported Event|Retinol|Retinol 1.0% cream
833553|NCT01283334|B1|Baseline|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
835698|NCT01276223|P1|Participant Flow|Run-In Only|Difluprednate vehicle
833554|NCT01283334|P1|Participant Flow|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
833555|NCT01283334|O1|Outcome|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
833556|NCT01283334|O2|Outcome|Everolimus Dose Level -1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level -1 (2.5 mg every other day)
833557|NCT01283334|O1|Outcome|Everolimus Dose Level 1 DLT|Carboplatin, cetuximab and RAD001 (everolimus) at Dose Level 1 (2.5 mg/day)
833558|NCT01283334|E1|Reported Event|Carboplatin, Cetuximab and Everolimus|"Carboplatin, cetuximab and RAD001 (everolimus)~Carboplatin, cetuximab and RAD001: For phase I, dose escalation will be 2.5mg, 5mg, 7.5mg or 10mg given orally on a daily basis"
833559|NCT01283321|B3|Baseline|Total|Total of all reporting groups
833560|NCT01283321|B2|Baseline|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
833561|NCT01283321|B1|Baseline|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
833562|NCT01283321|P2|Participant Flow|Group B: Apheresis Platelets|apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
833563|NCT01283321|P1|Participant Flow|Group A: RiaSTAP|Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
833564|NCT01283321|O2|Outcome|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
833565|NCT01283321|O1|Outcome|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
833566|NCT01283321|E2|Reported Event|Group B: Apheresis Platelets|"single apheresis unit~apheresis platelets: A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding."
833567|NCT01283321|E1|Reported Event|Group A: RiaSTAP|"Human fibrinogen concentrate~Human fibrinogen concentrate: 4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding"
833568|NCT01283282|B1|Baseline|All Subjects|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
833569|NCT01283282|P2|Participant Flow|Clopidogrel First/Then Placebo|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks then were switched to placebo PO qd therapy for an additional 6 weeks without any wash out period in between.
833570|NCT01283282|P1|Participant Flow|Placebo First/Then Clopidogrel|The subjects received placebo PO qd for the first 6 weeks then were switched to clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
833571|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
833572|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
833573|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
833574|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
833575|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
833576|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
833577|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
833578|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
833579|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
833580|NCT01283282|O1|Outcome|Clopidogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
833581|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
833582|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
833583|NCT01283282|O2|Outcome|Placebo|The subjects received placebo PO qd for the first 6 weeks or the subjects received placebo PO qd for the last 6 weeks.
833584|NCT01283282|O1|Outcome|Clopridogrel|The subjects received clopidogrel 75 mg PO qd for the first 6 weeks or received clopidogrel 75 mg PO qd for the last 6 weeks.
833585|NCT01283282|E2|Reported Event|Placebo|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
833586|NCT01283282|E1|Reported Event|Clopidogrel|The subjects received clopidogrel 75 mg or placebo PO qd for the first 6 weeks then were switched to receive either placebo or clopidogrel 75 mg PO qd therapy for an additional 6 weeks without any wash out period in between.
833587|NCT01283152|B3|Baseline|Total|Total of all reporting groups
833588|NCT01283152|B2|Baseline|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
833647|NCT01283139|E2|Reported Event|Sifalimumab 200 mg|Sifalimumab 200 milligram (mg) administered intravenously for 48 weeks (Day 337).
833589|NCT01283152|B1|Baseline|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
833590|NCT01283152|P2|Participant Flow|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
833591|NCT01283152|P1|Participant Flow|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
833592|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
833593|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
833594|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
833595|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
833596|NCT01283152|O2|Outcome|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
833597|NCT01283152|O1|Outcome|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
833598|NCT01283152|E2|Reported Event|Lactulose|"Per standard of care~Lactulose: If randomized to this arm, subjects will receive 10-30 grams per standard of care"
833599|NCT01283152|E1|Reported Event|Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®)|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®): If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
833600|NCT01283139|B5|Baseline|Total|Total of all reporting groups
833601|NCT01283139|B4|Baseline|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833602|NCT01283139|B3|Baseline|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833603|NCT01283139|B2|Baseline|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833604|NCT01283139|B1|Baseline|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833691|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833605|NCT01283139|P4|Participant Flow|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833606|NCT01283139|P3|Participant Flow|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833607|NCT01283139|P2|Participant Flow|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833608|NCT01283139|P1|Participant Flow|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833609|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833610|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833611|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833612|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833613|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833614|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833615|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833616|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833617|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833618|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833619|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833620|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833621|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833622|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833623|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833624|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833625|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833626|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833627|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833628|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833629|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833630|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833631|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
834215|NCT01280695|P3|Participant Flow|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
833632|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833633|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833634|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833635|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833636|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833637|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833638|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833639|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833640|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833641|NCT01283139|O4|Outcome|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833642|NCT01283139|O3|Outcome|Sifalimumab 600 mg|Sifalimumab 600 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833643|NCT01283139|O2|Outcome|Sifalimumab 200 Milligram (mg)|Sifalimumab 200 mg administered by intravenous infusion every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833644|NCT01283139|O1|Outcome|Placebo|Placebo matching to sifalimumab administered by intravenous infusion at a fixed dose of every 2 weeks (14 days) for the first 3 doses (Days 1, 15, and 29) and then every 4 weeks (28 days) thereafter for 11 doses for a total of 14 doses.
833645|NCT01283139|E4|Reported Event|Sifalimumab 1200 mg|Sifalimumab 1,200 mg administered intravenously for 48 weeks (Day 337).
833646|NCT01283139|E3|Reported Event|Sifalimumab 600 mg|Sifalimumab 600 mg administered intravenously for 48 weeks (Day 337).
833648|NCT01283139|E1|Reported Event|Placebo|Placebo matching to sifalimumab administered intravenously for 48 weeks (Day 337).
833649|NCT01283035|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833650|NCT01283035|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833651|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833652|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833653|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833654|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833655|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833656|NCT01283035|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833657|NCT01283035|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Akt inhibitor MK2206 will be taken PO once a week for four weeks (one cycle). Treatment will continue for as long as a subject is benefiting from the study drug.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
833658|NCT01283022|B1|Baseline|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
833820|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833659|NCT01283022|P1|Participant Flow|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
833660|NCT01283022|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
833661|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
833662|NCT01283022|O1|Outcome|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
833663|NCT01283022|E1|Reported Event|MVI 200|MVI 200 : Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
833664|NCT01282814|B3|Baseline|Total|Total of all reporting groups
833665|NCT01282814|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
833666|NCT01282814|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
833667|NCT01282814|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
833668|NCT01282814|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
833669|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833670|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833671|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833672|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
835699|NCT01276223|O2|Outcome|Vehicle|Difluprednate vehicle
833673|NCT01282814|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833674|NCT01282814|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833675|NCT01282814|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
833676|NCT01282814|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
833677|NCT01282801|B3|Baseline|Total|Total of all reporting groups
833678|NCT01282801|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
833679|NCT01282801|B1|Baseline|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
833680|NCT01282801|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
833681|NCT01282801|P1|Participant Flow|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
833682|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833683|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833684|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833685|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833686|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833687|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833688|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833689|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833690|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
834216|NCT01280695|P2|Participant Flow|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
833692|NCT01282801|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Extended-Release Capsules reference product dosed in either period.
833693|NCT01282801|O1|Outcome|Velafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
833694|NCT01282801|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Extended-Release Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
833695|NCT01282801|E1|Reported Event|Velafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
833696|NCT01282723|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833697|NCT01282723|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833698|NCT01282723|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833699|NCT01282723|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833700|NCT01282710|B1|Baseline|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833701|NCT01282710|P1|Participant Flow|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833702|NCT01282710|O1|Outcome|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833703|NCT01282710|E1|Reported Event|Pregnant, In Labor|Monitored simultaneously by SureCALL®, TOCO, and IUPC
833704|NCT01282476|B1|Baseline|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
833705|NCT01282476|P1|Participant Flow|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
833706|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
833707|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
833708|NCT01282476|O1|Outcome|Panobinostat/Rituximab|Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
833709|NCT01282476|E1|Reported Event|Panobinostat/Rituximab|"single-arm, open-label; Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.~Panobinostat with Rituximab: Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles."
833710|NCT01282424|B1|Baseline|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833711|NCT01282424|P1|Participant Flow|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833712|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833713|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833714|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833715|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833716|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833717|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833718|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833719|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833720|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833721|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833722|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833723|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833724|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833725|NCT01282424|O1|Outcome|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833726|NCT01282424|E1|Reported Event|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily until tumor progression or development of unacceptable toxicity.
833727|NCT01282372|B1|Baseline|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833728|NCT01282372|P1|Participant Flow|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833729|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833730|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833731|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833732|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833733|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833734|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833735|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
833736|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
833737|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
833738|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833739|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
833740|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833741|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
833742|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833743|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
833744|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833745|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
833746|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833747|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
833748|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833749|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
833750|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833751|NCT01282372|O3|Outcome|Participants With Moderate to Severe Rheumatic Disease - AS|Participants with moderate to severe rheumatic disease (AS), who received adalimumab in accordance with approved label
833752|NCT01282372|O2|Outcome|Participants With Moderate to Severe Rheumatic Disease - PsA|Participants with moderate to severe rheumatic disease (PsA), who received adalimumab in accordance with approved label
833753|NCT01282372|O1|Outcome|Participants With Moderate to Severe Rheumatic Disease - RA|Participants with moderate to severe rheumatic disease (RA), who received adalimumab in accordance with approved label
833754|NCT01282372|E1|Reported Event|Participants With Moderate to Severe Rheumatic Disease|Participants with moderate to severe rheumatic disease (RA, PsA, or AS), who received adalimumab in accordance with approved label
833755|NCT01282294|B1|Baseline|ETN PROtect|"There is only 1 cohort in this case series.~ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating"
833756|NCT01282294|P1|Participant Flow|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833757|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833758|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833759|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833760|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833761|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833762|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833763|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833764|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833765|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833766|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833767|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833768|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833769|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833770|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833771|NCT01282294|O1|Outcome|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833772|NCT01282294|E1|Reported Event|ETN PROtect|ETN PROtect: Expert Tibial Nail PROtect with Gentamicin coating.
833773|NCT01282242|B3|Baseline|Total|Total of all reporting groups
834217|NCT01280695|P1|Participant Flow|Placebo|Placebo capsule once daily
833774|NCT01282242|B2|Baseline|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833775|NCT01282242|B1|Baseline|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833776|NCT01282242|P2|Participant Flow|Secondary SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833777|NCT01282242|P1|Participant Flow|Primary SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833778|NCT01282242|O2|Outcome|SIR < 1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833779|NCT01282242|O1|Outcome|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833780|NCT01282242|O2|Outcome|SIR < 1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833781|NCT01282242|O1|Outcome|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833782|NCT01282242|E2|Reported Event|SIR <1.25|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.25 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833783|NCT01282242|E1|Reported Event|SIR <1.15|MRI confirmed early stroke onset, determined by Signal intensity ratio (SIR) <1.15 (SIR = Contralateral Region Of Interest (ROI)/Ipsilateral ROI)
833784|NCT01282229|B1|Baseline|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
833785|NCT01282229|P1|Participant Flow|All Participants|Subjects will receive the Laser Assisted New Attachment Procedure (LANAP protocol) using the pulsed FR Nd:YAG laser, Scaling and Root Planing alone, Modified Widman Flap surgery, and Coronal Debridement alone each in one randomized quadrant of their mouth at Baseline.
833786|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
833787|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
833788|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
833789|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
833790|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
833791|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
833792|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
835700|NCT01276223|O1|Outcome|Durezol|Difluprednate 0.5% ophthalmic emulsion
833793|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
833794|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
833795|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
833796|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
833797|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
833798|NCT01282229|O4|Outcome|Coronal Debridement|Quadrant treated with coronal debridement
833799|NCT01282229|O3|Outcome|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
833800|NCT01282229|O2|Outcome|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
833801|NCT01282229|O1|Outcome|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
833802|NCT01282229|O8|Outcome|Coronal Debridement (≥7mm Pockets)|Quadrant treated with coronal debridement
833803|NCT01282229|O7|Outcome|Coronal Debridement (5-6mm Pockets)|Quadrant treated with coronal debridement
833804|NCT01282229|O6|Outcome|Scaling and Root Planing (≥7mm Pockets)|Quadrant treated with scaling and root planing alone
833805|NCT01282229|O5|Outcome|Scaling and Root Planing (5-6mm Pockets)|Quadrant treated with scaling and root planing alone
833806|NCT01282229|O4|Outcome|Modified Widman Flap (≥7mm Pockets)|Quadrant treated with Modified Widman Flap surgery
833807|NCT01282229|O3|Outcome|Modified Widman Flap (5-6mm Pockets)|Quadrant treated with Modified Widman Flap surgery
833808|NCT01282229|O2|Outcome|LANAP Quadrant (≥7mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
833809|NCT01282229|O1|Outcome|LANAP Quadrant (5-6mm Pockets)|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
833810|NCT01282229|E4|Reported Event|Coronal Debridement|Quadrant treated with coronal debridement
833811|NCT01282229|E3|Reported Event|Scaling and Root Planing|Quadrant treated with scaling and root planing alone
833812|NCT01282229|E2|Reported Event|Modified Widman Flap|Quadrant treated with Modified Widman Flap surgery
833813|NCT01282229|E1|Reported Event|LANAP Quadrant|"Treated with LANAP~LANAP: Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser"
833814|NCT01282203|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833815|NCT01282203|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833816|NCT01282203|O3|Outcome|Anesthesia With Sevorane|Duration of experience with Sevorane.
833817|NCT01282203|O2|Outcome|Inhalation Anesthesia|Duration of experience with inhalation anesthesia.
833818|NCT01282203|O1|Outcome|General Anesthesia|Duration of experience with general anesthesia.
833819|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833821|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833822|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833823|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833824|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833825|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833826|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833827|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833828|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833829|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833830|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833831|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833832|NCT01282203|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833833|NCT01282203|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833834|NCT01282164|B3|Baseline|Total|Total of all reporting groups
833835|NCT01282164|B2|Baseline|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
833836|NCT01282164|B1|Baseline|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
833837|NCT01282164|P2|Participant Flow|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
833866|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
835701|NCT01276223|E3|Reported Event|Vehicle|Difluprednate vehicle
833838|NCT01282164|P1|Participant Flow|Study Patients|"patients with growth hormone deficiency or hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg adrenocorticotropin hormone (ACTH) stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure"
833839|NCT01282164|O1|Outcome|Patients Older Than 65|Three patients with adult onset hypothalamic-pituitary disease underwent who were older than 65 years of age underwent ACTH stimulation test instead of ITT.
833840|NCT01282164|O3|Outcome|Patients With 3 or More PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
833841|NCT01282164|O2|Outcome|Patients With 3 or More PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
833842|NCT01282164|O1|Outcome|Patients With 3 or More PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
833843|NCT01282164|O3|Outcome|Control Group- Weight-based GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
833844|NCT01282164|O2|Outcome|Control Group- Fixed-dose GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
833845|NCT01282164|O1|Outcome|Control Group- ITT|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg
833846|NCT01282164|O3|Outcome|Patients With 1-2 PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
833847|NCT01282164|O2|Outcome|Patients With 1-2 PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
833848|NCT01282164|O1|Outcome|Patients With 1-2 PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
833849|NCT01282164|O3|Outcome|Patients With 3 or More PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
833850|NCT01282164|O2|Outcome|Patients With 3 or More PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency
833851|NCT01282164|O1|Outcome|Patients With 3 or More PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and three or more pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
833852|NCT01282164|O3|Outcome|Control Group- Weight-based GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
834218|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
833853|NCT01282164|O2|Outcome|Control Group- Fixed-dose GST|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.
833854|NCT01282164|O1|Outcome|Control Group- ITT|The control group consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site did not enroll the control group. All underwent insulin tolerance test using 0.10-0.15 U/kg
833855|NCT01282164|O3|Outcome|Patients With 1-2 PHD- Weight Based GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
833856|NCT01282164|O2|Outcome|Patients With 1-2 PHD- Fixed Dose GST|Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency
833857|NCT01282164|O1|Outcome|Patients With 1-2 PHD- Insulin Tolerance Test|"Patients with hypothalamic-pituitary disorders and 1-2 pituitary hormone deficiency (PHD) other than GH deficiency~insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test was used in 3 subjects who were not eligible for ITT"
833858|NCT01282164|E2|Reported Event|Control|"The control group will consist of healthy volunteers matched to the study group for age, gender, BMI and estrogen status. Note: Allegheny site is not enrolling in the control group.~glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
833859|NCT01282164|E1|Reported Event|Study Patients|"patients with hypothalamic-pituitary disorders~Glucagon stimulation test and insulin tolerance test: glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with T2DM, CAD, CVD, seizure"
833860|NCT01282138|B3|Baseline|Total|Total of all reporting groups
833861|NCT01282138|B2|Baseline|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833862|NCT01282138|B1|Baseline|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833863|NCT01282138|P2|Participant Flow|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833864|NCT01282138|P1|Participant Flow|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833865|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833867|NCT01282138|O2|Outcome|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833868|NCT01282138|O1|Outcome|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833869|NCT01282138|E2|Reported Event|Tears Naturale II|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833870|NCT01282138|E1|Reported Event|Patanol|One drop twice daily in each eye for five days prior to allergen provocation testing, followed by an additional drop in each eye approximately 15 minutes prior to start of testing.
833871|NCT01282086|B1|Baseline|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833872|NCT01282086|P1|Participant Flow|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833873|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833874|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833875|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833876|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833877|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833878|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833879|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833880|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833881|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery.
833882|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833883|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833884|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833885|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833886|NCT01282086|O1|Outcome|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833887|NCT01282086|E1|Reported Event|Adults Requiring Anesthesia for Surgery|Adult patients requiring general anesthesia for surgery
833888|NCT01281865|B3|Baseline|Total|Total of all reporting groups
833889|NCT01281865|B2|Baseline|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833890|NCT01281865|B1|Baseline|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833891|NCT01281865|P2|Participant Flow|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833892|NCT01281865|P1|Participant Flow|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833893|NCT01281865|O2|Outcome|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833894|NCT01281865|O1|Outcome|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833895|NCT01281865|E2|Reported Event|Arm 2-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 10 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833896|NCT01281865|E1|Reported Event|Arm 1-Treatment (Everolimus and Imatinib Mesylate)|Cycle=28 days: Everolimus: 5 mg PO QD, STI571 (imatinib, Gleevec): 400 mg PO QD
833897|NCT01281839|B3|Baseline|Total|Total of all reporting groups
833898|NCT01281839|B2|Baseline|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833899|NCT01281839|B1|Baseline|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833900|NCT01281839|P2|Participant Flow|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833901|NCT01281839|P1|Participant Flow|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833902|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833903|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
835702|NCT01276223|E2|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion
833904|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833905|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833906|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833907|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833908|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833909|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833910|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833911|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833912|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833913|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
834014|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834219|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
833914|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833915|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833916|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833917|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833918|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833919|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833920|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833921|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833922|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833963|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
833923|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833924|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833925|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833926|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833927|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833928|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833929|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833930|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833931|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833932|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833933|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
834015|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
833934|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833935|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833936|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833937|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833938|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833939|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833940|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833941|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833942|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833943|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833944|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833945|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833946|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833947|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833948|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833949|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833950|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833951|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833952|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833953|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
834120|NCT01281306|E2|Reported Event|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
833954|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833955|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833956|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833957|NCT01281839|O2|Outcome|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833958|NCT01281839|O1|Outcome|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833959|NCT01281839|E2|Reported Event|PBO 12Wks PR48|Participants were given placebo (PBO) once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 48 (PR 48).
833960|NCT01281839|E1|Reported Event|TMC435 150mg 12Wks PR24/48|Participants were given TMC435 150 mg once daily plus peginterferon alpha-2a (PegIFN alpha-2a) and ribavirin (RBV) for 12 Weeks (Wks) followed by PegIFN alpha-2a (P) and RBV (R) until Week 24 (PR24). Treatment was to be stopped at Week 24 for participants who achieved HCV RNA < 25 IU/mL detectable or undetectable at Week 4 and undetectable HCV RNA at Week 12. Other participants continued PR until Week 48 (PR48).
833961|NCT01281644|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
833962|NCT01281644|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual arm within each subject to receive either laser therapy on the right arm or on the left arm.~Each subject received treatment using the 810 nm pulsed diode laser to the arm randomized to be the treatment site."
833964|NCT01281644|O1|Outcome|No Laser Treatment|
833965|NCT01281644|O2|Outcome|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
833966|NCT01281644|O1|Outcome|No Laser Treatment|
833967|NCT01281644|E2|Reported Event|45-60 J Diode Laser Therapy|"Diode laser therapy will be initiated at 45-60 J for 30 ms to 100 ms.~Diode Laser: 810 nm diode laser"
833968|NCT01281644|E1|Reported Event|No Laser Treatment|
833969|NCT01281501|B3|Baseline|Total|Total of all reporting groups
833970|NCT01281501|B2|Baseline|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
833971|NCT01281501|B1|Baseline|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
833972|NCT01281501|P2|Participant Flow|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
833973|NCT01281501|P1|Participant Flow|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
833974|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
833975|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
833976|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
833977|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
833978|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
833979|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
833980|NCT01281501|O2|Outcome|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
833981|NCT01281501|O1|Outcome|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
833982|NCT01281501|E2|Reported Event|Pantoprazole|Oral antacid, 20 mg of intravenous hyoscine butylbromide, 80 mg of intravenous pantoprazole
833983|NCT01281501|E1|Reported Event|Conventional|Oral antacid, 20 mg of intravenous hyoscine butylbromide, normal saline
833984|NCT01281475|B3|Baseline|Total|Total of all reporting groups
833985|NCT01281475|B2|Baseline|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~It is also taken 3 times a day, just like Levodopa."
833986|NCT01281475|B1|Baseline|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
833987|NCT01281475|P2|Participant Flow|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
834155|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
833988|NCT01281475|P1|Participant Flow|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
833989|NCT01281475|O2|Outcome|Placebo|"The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa, so it is not expected to have any effect.~Placebo Oral Capsule: The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa."
833990|NCT01281475|O1|Outcome|Levodopa|"Levodopa is prescribed as a combination of levodopa/carbidopa (4:1) to reduce the peripheral side effects. The dosage used was 15 mg/kg/day in 3 divided doses.~Levodopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
833991|NCT01281475|O2|Outcome|Placebo|"The placebo (in this study, microcellulose) is not expected to have any effect.~The placebo capsules are taken 3 times a day, just like the levodopa / carbidopa capsules"
833992|NCT01281475|O1|Outcome|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
833993|NCT01281475|E2|Reported Event|Placebo|The placebo (in this study, microcellulose) is not expected to have any effect.
833994|NCT01281475|E1|Reported Event|Levodopa|"Levodopa is a prodrug that delivers dopamine to the brain. It is usually given with carbidopa, a peripheral decarboxylase inhibitor, to increase the bioavailability of levodopa.~Levodopa/carbidopa: Levodopa/Carbidopa (4:1)~Dosages are based on levodopa.~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
833995|NCT01281306|B8|Baseline|Total|Total of all reporting groups
833996|NCT01281306|B7|Baseline|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
833997|NCT01281306|B6|Baseline|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
833998|NCT01281306|B5|Baseline|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
833999|NCT01281306|B4|Baseline|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834000|NCT01281306|B3|Baseline|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834001|NCT01281306|B2|Baseline|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834002|NCT01281306|B1|Baseline|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834003|NCT01281306|P7|Participant Flow|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834004|NCT01281306|P6|Participant Flow|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834005|NCT01281306|P5|Participant Flow|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834006|NCT01281306|P4|Participant Flow|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834007|NCT01281306|P3|Participant Flow|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834008|NCT01281306|P2|Participant Flow|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834009|NCT01281306|P1|Participant Flow|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834010|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834011|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834012|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834013|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834210|NCT01280695|B3|Baseline|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834016|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834017|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834018|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834019|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834020|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834021|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834022|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834023|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834024|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834025|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834026|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834027|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834028|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834029|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834030|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834031|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834378|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834032|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834033|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834034|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834035|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834036|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834037|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834038|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834039|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834040|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834041|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834042|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834043|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834044|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834045|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834046|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834047|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834048|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834049|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834050|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834051|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834052|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834053|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834054|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834055|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834056|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834057|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834058|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834059|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834060|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834061|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834062|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834063|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834064|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834065|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834066|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834067|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834068|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834069|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834070|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834071|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834072|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834073|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834074|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834075|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834076|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834077|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834078|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834079|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834080|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834081|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834082|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834083|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834084|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834085|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834086|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834087|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834088|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834089|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834090|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834091|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834092|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834093|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834094|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834095|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834096|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834097|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834098|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834099|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834100|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834101|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834102|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834103|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834104|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834105|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834106|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834107|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834108|NCT01281306|O7|Outcome|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834109|NCT01281306|O6|Outcome|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834110|NCT01281306|O5|Outcome|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834111|NCT01281306|O4|Outcome|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834112|NCT01281306|O3|Outcome|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834113|NCT01281306|O2|Outcome|VAL + AHU 200 mg|Participants were started with AHU377 100 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for the remaining 7 weeks.
834114|NCT01281306|O1|Outcome|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834115|NCT01281306|E7|Reported Event|Placebo|Participants received matching placebo to LCZ696, AHU377 and valsartan for 8 weeks.
834116|NCT01281306|E6|Reported Event|LCZ 400 mg|Participants were started with LCZ696 200 mg qd for 1 week and then were uptitrated to LCZ696 400 mg qd for the remaining 7 weeks.
834117|NCT01281306|E5|Reported Event|VAL 320 mg|Participants were started with valsartan 160 mg qd for 1 week and then were uptitrated to valsartan 320 mg qd for the remaining 7 weeks.
834118|NCT01281306|E4|Reported Event|VAL + AHU 50 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 50 mg + valartan 320 mg qd for the remaining 7 weeks.
834119|NCT01281306|E3|Reported Event|VAL + AHU 100 mg|Participants were started with AHU377 50 mg + valsartan 160 mg qd for 1 week and then were uptitrated to AHU377 100 mg + valsartan 320 mg for the remaining 7 weeks.
834211|NCT01280695|B2|Baseline|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834212|NCT01280695|B1|Baseline|Placebo|Placebo capsule once daily
834121|NCT01281306|E1|Reported Event|VAL + AHU 400 mg|Participants were started with AHU377 100 mg + valsartan 160 mg every day (qd) for 1 week, then were uptitrated to AHU377 200 mg + valsartan 320 mg qd for another week, and then were uptitrated to AHU377 400 mg + valsartan 320 mg for the remaining 6 weeks.
834122|NCT01281202|B3|Baseline|Total|Total of all reporting groups
834123|NCT01281202|B2|Baseline|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
834124|NCT01281202|B1|Baseline|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
834125|NCT01281202|P2|Participant Flow|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
834126|NCT01281202|P1|Participant Flow|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
834127|NCT01281202|O2|Outcome|Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received Vigabatrin matching placebo tablets, bid, for 9 weeks~Subject were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
834128|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase~During treatment, subject received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
834129|NCT01281202|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During Treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
834130|NCT01281202|O1|Outcome|CPP-109 Vigabatrin Tablets|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase. During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks.~Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13)"
834131|NCT01281202|E2|Reported Event|Placebo|Participants received Vigabatrin placebo table orally once daily for 7 weeks.
834132|NCT01281202|E1|Reported Event|CPP-109 Vigabatrin Tablets|Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks.
834133|NCT01281124|B1|Baseline|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
834507|NCT01279564|P2|Participant Flow|Control|"Intubation~Endotracheal tube- standard"
834134|NCT01281124|P1|Participant Flow|Treatment (5-Azacytidine)|Patients receive 5-azacitidine subcutaneously at the starting dose level of 75 mg/m2 on an outpatient basis daily for 7 days on a 28 day cycle.
834135|NCT01281124|O1|Outcome|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
834136|NCT01281124|O1|Outcome|Treatment (5-Azacytidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
834137|NCT01281124|O1|Outcome|Treatment (5-Azacyitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
834138|NCT01281124|E1|Reported Event|Treatment (Azacitidine)|Patients receive azacitidine subcutaneously on days 1-7. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
834139|NCT01281007|B3|Baseline|Total|Total of all reporting groups
834140|NCT01281007|B2|Baseline|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
834141|NCT01281007|B1|Baseline|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
834142|NCT01281007|P2|Participant Flow|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
834143|NCT01281007|P1|Participant Flow|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
834144|NCT01281007|O2|Outcome|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
834145|NCT01281007|O1|Outcome|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
834146|NCT01281007|E2|Reported Event|Aciclovir 200 mg|"1 tablet every 4 hours (excluding nocturnal dose) for 5 days~Aciclovir: Aciclovir 200 mg every 4 hours fo 5 days"
834147|NCT01281007|E1|Reported Event|Famciclovir 125 mg|"1 tablet every 12 hours for 5 days~Famciclovir: Famciclovir 125 mg every 12 hours for 5 days"
834148|NCT01280981|B1|Baseline|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834149|NCT01280981|P1|Participant Flow|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834150|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834151|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834152|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834153|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834154|NCT01280981|O1|Outcome|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834213|NCT01280695|P5|Participant Flow|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834156|NCT01280981|E1|Reported Event|Tranexamic Acid|Two 650 mg tablets orally 3 times per day with liquids for up to 5 days (not to exceed 3 doses in 1 day or 15 doses during the menstrual period).
834157|NCT01280968|B3|Baseline|Total|Total of all reporting groups
834158|NCT01280968|B2|Baseline|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
834159|NCT01280968|B1|Baseline|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
834160|NCT01280968|P2|Participant Flow|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
834161|NCT01280968|P1|Participant Flow|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
834162|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
834163|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
834164|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
834165|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
834166|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
834167|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
834168|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
834169|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
834170|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
834171|NCT01280968|O3|Outcome|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
834172|NCT01280968|O2|Outcome|NIC002, Tertile With Highest Antibody Binding Capacity|
834173|NCT01280968|O1|Outcome|NIC002 Vaccine in Aluminum Hydroxide, All Vaccinated Subjects|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
834174|NCT01280968|E2|Reported Event|Placebo Vaccine - Aluminum Hydroxide|4 placebo injections were administered subcutaneously over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 0.46 mg aluminum hydroxide.
834175|NCT01280968|E1|Reported Event|NIC002 Vaccine in Aluminum Hydroxide|4 subcutaneous vaccinations were performed over the course of 3 months, with 4 weeks between each vaccination. The administered volume of 0.65 mL of sterile water contained 100 μg of NIC002 and 0.46 mg aluminum hydroxide.
834176|NCT01280955|B1|Baseline|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834177|NCT01280955|P1|Participant Flow|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834178|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834179|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834180|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834181|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834182|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834183|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834214|NCT01280695|P4|Participant Flow|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834184|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834185|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834186|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834187|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834188|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834189|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834190|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834191|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834192|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834193|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834194|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834195|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834196|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834197|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834198|NCT01280955|O1|Outcome|Transplant Recipients|"Transplant recipients from matched sibling donors and dual cord donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Plerixafor: Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs."
834199|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834200|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834201|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834202|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834203|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834204|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834205|NCT01280955|O1|Outcome|Transplant Recipients|This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
834206|NCT01280955|E1|Reported Event|Transplant Recipients|"This arm includes transplant recipients from matched sibling donors and dual cord blood donors. Subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.~Adverse Events were monitored for 29 transplant recipients"
834207|NCT01280695|B6|Baseline|Total|Total of all reporting groups
834208|NCT01280695|B5|Baseline|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834209|NCT01280695|B4|Baseline|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834220|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834221|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834222|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
834223|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834224|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834225|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834226|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834227|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
834228|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834229|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834230|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834231|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834232|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
834233|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834234|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834235|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834236|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834237|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
834238|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834239|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834240|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834241|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834242|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
834243|NCT01280695|O5|Outcome|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834244|NCT01280695|O4|Outcome|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834245|NCT01280695|O3|Outcome|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834246|NCT01280695|O2|Outcome|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834247|NCT01280695|O1|Outcome|Placebo|Placebo capsule once daily
834248|NCT01280695|E5|Reported Event|Pioglitazone 45 mg|Pioglitazone capsule 45 mg once daily
834249|NCT01280695|E4|Reported Event|MSDC-0602 500 mg|MSDC-0602 capsule 500 mg once daily
834250|NCT01280695|E3|Reported Event|MSDC-0602 250 mg|MSDC-0602 capsule 250 mg once daily
834251|NCT01280695|E2|Reported Event|MSDC-0602 100 mg|MSDC-0602 capsule 100 mg once daily
834252|NCT01280695|E1|Reported Event|Placebo|Placebo capsule once daily
834253|NCT01280656|B4|Baseline|Total|Total of all reporting groups
834254|NCT01280656|B3|Baseline|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834255|NCT01280656|B2|Baseline|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834256|NCT01280656|B1|Baseline|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834257|NCT01280656|P3|Participant Flow|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834258|NCT01280656|P2|Participant Flow|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834259|NCT01280656|P1|Participant Flow|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for Chronic Hepatitis C (CHC) according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834260|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834261|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834262|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834263|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834264|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834265|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834318|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834266|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834267|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834268|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834269|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834270|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834271|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834272|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834273|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834274|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834275|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
835703|NCT01276223|E1|Reported Event|Run-In|Difluprednate vehicle, all patients
834276|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834277|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834278|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834279|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834280|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834281|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834282|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834283|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834284|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834285|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834286|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834287|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834288|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834289|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834290|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834291|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834292|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834293|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834294|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834295|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834296|NCT01280656|O3|Outcome|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834297|NCT01280656|O2|Outcome|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
834298|NCT01280656|O1|Outcome|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were observed during treatment period (48 weeks) and follow up period (24 weeks).
835704|NCT01276197|B3|Baseline|Total|Total of all reporting groups
834299|NCT01280656|E3|Reported Event|Peginterferon Alfa-2b Plus Ribavirin|Eligible participants who received peginterferon alfa-2b plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
834300|NCT01280656|E2|Reported Event|Peginterferon Alfa-2a Plus Ribavirin|Eligible participants who received peginterferon alfa-2a plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy
834301|NCT01280656|E1|Reported Event|Conventional Interferon Plus Ribavirin|Eligible participants who received conventional interferon plus ribavirin for CHC according to the standard of care and aligned with the local prescription instructions were retrospectively assessed up to a minimum of 12 weeks after the end of therapy.
834302|NCT01280604|B3|Baseline|Total|Total of all reporting groups
834303|NCT01280604|B2|Baseline|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834304|NCT01280604|B1|Baseline|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834305|NCT01280604|P2|Participant Flow|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834306|NCT01280604|P1|Participant Flow|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834307|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834308|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834309|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834310|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834311|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834312|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834313|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834314|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834315|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834316|NCT01280604|O1|Outcome|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834317|NCT01280604|O2|Outcome|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834442|NCT01280266|B1|Baseline|Amlodipine-Udenafil (AU) Arm|Amlodipine first, then Udenafil
834319|NCT01280604|E2|Reported Event|Control|Subjects in the control group will be remain on 160mg of fenofibrate daily for the duration of the study (6-8 weeks).
834320|NCT01280604|E1|Reported Event|Intervention|"Subjects in the dose reduction group will be converted from 160mg of fenofibrate to 54mg of fenofibrate daily for 6-8 weeks.~Fenofibrate 54mg: Subjects will receive fenofibrate 54mg daily."
834321|NCT01280591|B5|Baseline|Total|Total of all reporting groups
834322|NCT01280591|B4|Baseline|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834323|NCT01280591|B3|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834324|NCT01280591|B2|Baseline|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834325|NCT01280591|B1|Baseline|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834326|NCT01280591|P4|Participant Flow|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834327|NCT01280591|P3|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834328|NCT01280591|P2|Participant Flow|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834329|NCT01280591|P1|Participant Flow|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834330|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834331|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834332|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834333|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834334|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834335|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834336|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834337|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834338|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834339|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834340|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834341|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834342|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834343|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834344|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834345|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834346|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834347|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834348|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834349|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834350|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834351|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834352|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834353|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834354|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834355|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834356|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834357|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834358|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834359|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834360|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834361|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834362|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834363|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834364|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834365|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834366|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834367|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834368|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834369|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834370|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834371|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834372|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834373|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834374|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834375|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834376|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834377|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834379|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834380|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834381|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834382|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834383|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834384|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834385|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834386|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834387|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834388|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834389|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834390|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834391|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834392|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834393|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834394|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834395|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834396|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834397|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834398|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834399|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834400|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834401|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834402|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834403|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834404|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834405|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834406|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834407|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834408|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834409|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834410|NCT01280591|O4|Outcome|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834411|NCT01280591|O3|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834412|NCT01280591|O2|Outcome|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834413|NCT01280591|O1|Outcome|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834414|NCT01280591|E4|Reported Event|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
834415|NCT01280591|E3|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
834416|NCT01280591|E2|Reported Event|Naproxen Sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
834417|NCT01280591|E1|Reported Event|Naproxen Sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
834418|NCT01280552|B3|Baseline|Total|Total of all reporting groups
834419|NCT01280552|B2|Baseline|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
834420|NCT01280552|B1|Baseline|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
834421|NCT01280552|P2|Participant Flow|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
834422|NCT01280552|P1|Participant Flow|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
834423|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
834424|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
834425|NCT01280552|O2|Outcome|Control|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
834426|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
834427|NCT01280552|O2|Outcome|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
834428|NCT01280552|O1|Outcome|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
834429|NCT01280552|O2|Outcome|Control Dendritic Cells|Treatment with autologous dendritic cells not pulsed with immunogenic peptides
834430|NCT01280552|O1|Outcome|ICT-107|Treatment with autologous dendritic cells pulsed with immunogenic peptides
834431|NCT01280552|E2|Reported Event|Placebo|"Autologous dendritic cells that have not been pulsed with antigens~Placebo DC: Autologous dendritic cells (DC) that have not been pulsed with antigens"
834432|NCT01280552|E1|Reported Event|ICT-107|"Autologous dendritic cells pulsed with immunogenic peptides from tumor antigens~ICT-107: Autologous dendritic cells pulsed with immunogenic antigens"
834433|NCT01280357|B1|Baseline|Monitor With the Philips 50XM, Remove Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the predicate Tocco device
834434|NCT01280357|P1|Participant Flow|All Participants|during labor & delivery fetal heart rate, maternal heart rate and uterine contractions were monitored simultaneously by the Monia AN24 & the Philips 50XM
834435|NCT01280357|O1|Outcome|All Participants|all participants that had maternal heart rate measured with the Monica AN24 & the Philips 50XM
834436|NCT01280357|O1|Outcome|All Participants|all participants that had fetal heart rate measured with the Monica AN24 & the Philips 50XM
834437|NCT01280357|O1|Outcome|All Participants|Continue monitoring with the Philips 50XM and disconnect the Monica AN24 monitor.
834438|NCT01280357|E2|Reported Event|Monica AN24|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
834439|NCT01280357|E1|Reported Event|Philips 50XM,|Intervention required if not confident of AN24 data is to remove the AN24 and continue monitoring with the Philips 50XM
834440|NCT01280266|B3|Baseline|Total|Total of all reporting groups
834441|NCT01280266|B2|Baseline|Udenafil-Amlodipine (UA) Arm|Udenafil first, then Amlodipine
834443|NCT01280266|P2|Participant Flow|Udenafil-Amlodipine (UA) Arm|Udenafil 100mg PO QD for 4 weeks, washout period for 1 week, then Udenafil 10mg PO QD for 4 weeks.
834444|NCT01280266|P1|Participant Flow|Amlodipine-Udenafil (AU) Arm|Amlodipine 10mg PO QD for 4 weeks, washout period for 1week, then Udenafil 100mg PO QD for 4 weeks.
834445|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
834446|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
834447|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
834448|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
834449|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
834450|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
834451|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
834452|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
834453|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
834454|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
834455|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
834456|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
834457|NCT01280266|O2|Outcome|Udenafil|Drug: udenafil 10 mg p.o. per day
834458|NCT01280266|O1|Outcome|Amlodipine|Drug: amlodipine 100 mg p.o. per day
834459|NCT01280266|O2|Outcome|Udenafil|Changes in RPS during udenafil 10 mg orally per day
834460|NCT01280266|O1|Outcome|Amlodipine|Changes in RPS during amlodipine 100 mg orally per day
834461|NCT01280266|O2|Outcome|Udenafil|Changes in RP attacks per day during udenafil 100mg orally per day
834462|NCT01280266|O1|Outcome|Amlodipine|Changes in RP attacks per day during amlodipine 10 mg orally per day
834463|NCT01280266|E2|Reported Event|Udenafil|Adverse effects observed while taking udenafil in both study arms
834464|NCT01280266|E1|Reported Event|Amlodipine|Adverse effects observed while taking amlodipine in both study arms
834465|NCT01280123|B4|Baseline|Total|Total of all reporting groups
834466|NCT01280123|B3|Baseline|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834467|NCT01280123|B2|Baseline|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834468|NCT01280123|B1|Baseline|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834469|NCT01280123|P3|Participant Flow|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834470|NCT01280123|P2|Participant Flow|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834471|NCT01280123|P1|Participant Flow|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834472|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834473|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834474|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834475|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834534|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|"Formula with probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG"
834535|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
834476|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834477|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834478|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834479|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834480|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834481|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834482|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
835795|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
834483|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834484|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834485|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834486|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834487|NCT01280123|O3|Outcome|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834488|NCT01280123|O2|Outcome|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834489|NCT01280123|O1|Outcome|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834490|NCT01280123|E3|Reported Event|Matching Placebo|"Placebo~placebo: Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule."
834491|NCT01280123|E2|Reported Event|45 mg Pioglitazone|"45 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834492|NCT01280123|E1|Reported Event|15 mg Pioglitazone|"15 mg pioglitazone~Pioglitazone: Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd or matching placebo~44 weeks: Subjects who are on stable dose of rasagiline 1 mg/day or selegiline 10 mg/day, for at least 8 weeks but no more than 8 months, will begin randomized dose of study drug. Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated. Subjects will be followed on study drug for 44 weeks."
834493|NCT01280110|B3|Baseline|Total|Total of all reporting groups
834494|NCT01280110|B2|Baseline|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
834495|NCT01280110|B1|Baseline|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
834496|NCT01280110|P2|Participant Flow|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
834497|NCT01280110|P1|Participant Flow|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
834498|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
834499|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The central macular thickness was obtained through Cirrus™ HD-OCT (Zeiss). Mode 512x128 macular cube scan
834500|NCT01280110|O2|Outcome|Preservative-free Lubricating Drops|he second group will receive preservative-free lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
834501|NCT01280110|O1|Outcome|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month. The flare will be evaluated with Laser Flare Cell Meter (Kowa, FM 500, Japan). The patients will have 3 evaluations (baseline, 15 days and 30 days). The baseline measure is done before the use of the eyedrops.
834502|NCT01280110|E2|Reported Event|Preservative-free Lubricating Drops|The second group will receive preservative-free lubricating drops 4 times a day for 1 month.
834503|NCT01280110|E1|Reported Event|Preserved (BAK 0.006%) Lubricating Drop|One group will receive preserved lubricating drops 4 times a day for 1 month.
834504|NCT01279564|B3|Baseline|Total|Total of all reporting groups
834505|NCT01279564|B2|Baseline|Control|"Intubation~Endotracheal tube: Intubation"
834506|NCT01279564|B1|Baseline|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
834508|NCT01279564|P1|Participant Flow|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation"
834509|NCT01279564|O2|Outcome|Control|"Intubation~Duration of intubation"
834510|NCT01279564|O1|Outcome|ETview|"Endotracheal intubation with ETview TVT~Duration of intubation"
834511|NCT01279564|E2|Reported Event|Control|"Intubation~Endotracheal tube: Intubation~No adverse events"
834512|NCT01279564|E1|Reported Event|ETview|"Endotracheal intubation with ETview TVT~ETview TVT endotracheal tube: intubation~No adverse events"
834513|NCT01279447|B3|Baseline|Total|Total of all reporting groups
834514|NCT01279447|B2|Baseline|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
834515|NCT01279447|B1|Baseline|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
834516|NCT01279447|P2|Participant Flow|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
834517|NCT01279447|P1|Participant Flow|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
834518|NCT01279447|O2|Outcome|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
834519|NCT01279447|O1|Outcome|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
834520|NCT01279447|E2|Reported Event|Infrapatellar Nerve Block|"An infrapatellar nerve block performed under US guidance with 0.25% bupivacaine~0.25% Bupivacaine: 10cc, single dose, US guided injection"
834521|NCT01279447|E1|Reported Event|Placebo|"A sham infrapatellar block performed under US guidance with normal saline~Normal Saline: 10cc, single dose, US guided injection"
834522|NCT01279317|B1|Baseline|Vinegar Co-ingestion|All participants performed both intervention periods.
834523|NCT01279317|P2|Participant Flow|Placebo Co-ingestion First, Then Vinegar Co-ingestion|First acute experiment with placebo-coingestion (1 day), after 1 week washout experiment with vinegar co-ingestion (1 day).
834524|NCT01279317|P1|Participant Flow|Vinegar Co-ingestion First, Then Placebo Co-intestion|First acute experiment with vinegar-coingestion (1 day), after 1 week washout, experiment with placebo co-ingestion (1 day).
834525|NCT01279317|O2|Outcome|Placebo Co-ingestion|
834526|NCT01279317|O1|Outcome|Vinegar Co-ingestion|
834527|NCT01279317|E1|Reported Event|Vinegar Co-ingestion|All participants performed both intervention periods.
834528|NCT01279265|B3|Baseline|Total|Total of all reporting groups
834529|NCT01279265|B2|Baseline|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
834530|NCT01279265|B1|Baseline|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
834531|NCT01279265|P2|Participant Flow|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
834532|NCT01279265|P1|Participant Flow|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
834533|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without probiotics (Lactobaccillus Rhamnosus GG)~Nutramigen A+: Hypoallergenic formula without lactobacillus"
834536|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
834537|NCT01279265|O2|Outcome|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
834538|NCT01279265|O1|Outcome|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
834539|NCT01279265|E2|Reported Event|Nutramigen A+|"Hypoallergenic formula without lactobacilli~Nutramigen A+: Hypoallergenic formula without lactobacillus"
834540|NCT01279265|E1|Reported Event|Nutramigen Lipil With Enflora|Nutramigen with Enflora: Hypoallergenic formula with probiotic - Lactobacillus GG
834541|NCT01279200|B3|Baseline|Total|Total of all reporting groups
834542|NCT01279200|B2|Baseline|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
834543|NCT01279200|B1|Baseline|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
834544|NCT01279200|P2|Participant Flow|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
834545|NCT01279200|P1|Participant Flow|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
834546|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
834547|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
835450|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
834548|NCT01279200|O2|Outcome|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
834549|NCT01279200|O1|Outcome|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
834550|NCT01279200|E2|Reported Event|Midcycle Ultrasound + hCG Injection|"Patients randomized to this arm will undergo ovulation monitoring with midcycle ultrasound and receive hCG injection if evidence of a mature size follicle.~Midcycle ultrasound + hCG injection: Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate."
834551|NCT01279200|E1|Reported Event|Urinary LH Kits|"Patients randomized to this arm will monitor ovulation with home-based urinary LH kits (Ovulation Predictor Kits, OPK's).~Urinary LH kits: Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination."
834552|NCT01279109|B3|Baseline|Total|Total of all reporting groups
834553|NCT01279109|B2|Baseline|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
834554|NCT01279109|B1|Baseline|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
834555|NCT01279109|P2|Participant Flow|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
834556|NCT01279109|P1|Participant Flow|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
834557|NCT01279109|O2|Outcome|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
834558|NCT01279109|O1|Outcome|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
834559|NCT01279109|O2|Outcome|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
834560|NCT01279109|O1|Outcome|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
834561|NCT01279109|E2|Reported Event|Home Visit|"Home visits focused on preventable infant injuries~Home visit: Three home visits during pregnancy focused on providing education on infant injury prevention"
834649|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834562|NCT01279109|E1|Reported Event|Social Network Building Intervention|"Healthy lifestyle intervention focused on building healthy lifestyle skills and reciprocal social ties between the intervention group members~Social network building intervention: Group support and 12 weekly health education/skills building sessions during pregnancy"
834563|NCT01279070|B3|Baseline|Total|Total of all reporting groups
834564|NCT01279070|B2|Baseline|Repyflec Training|Cognitive remediation treatment
834565|NCT01279070|B1|Baseline|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
834566|NCT01279070|P2|Participant Flow|Leisure Group (Control Group)|"Leisure group~Parallel to the experimental group, a leisure control group was established which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, etc.) over 4 months twice a week and lasting 1 h."
834567|NCT01279070|P1|Participant Flow|Experimental Group (Repyflec Cognitive Remediation)|"Cognitive remediation (CR) group training (Repyflec)~REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations,examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF)."
834568|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
834569|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
834570|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
834571|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
834572|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
834573|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
834574|NCT01279070|O2|Outcome|Leisure Group|Leisure group has got same number of sessions and timing than experimental group
834575|NCT01279070|O1|Outcome|Repyflec Training|Cognitive remediation treatment
834576|NCT01279070|O2|Outcome|Leisure & Socialization Group|"Parallel to the experimental group, a leisure group was established (control group) which participated in 32 stimulating and socializing activities (e.g., card games, board games, coffee & talk, geography review, etc)."
834628|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834577|NCT01279070|O1|Outcome|REPYFLEC Cognitive Group Trainining|"REPYFLEC is a strategy-based training, explicitly described from session to session, which is carried out using pencil and paper with a blackboard as visual support. This format allows results to be replicated with rigour. The working content is divided into two principal areas: Problem solving (PS) and Cognitive Flexibility (CF). In the PS block, training in executive function, the thinking process and self-monitoring was emphasized. In the CF block, the tasks require the use of cognitive flexibility for successful completion. Some activities seek to promote training of other functions such as memory, working memory, sustained attention and language. Development of training was performed taking into account the contextual bases of learning, mainly using techniques as modelling to foster coping abilities, molding, self-monitoring, errorless learning and Socratic questioning. REPYFLEC is carried out in a group format (4-6), consisting of 32 sessions lasting 1 hour."
834578|NCT01279070|O2|Outcome|Leisure & Socialization Group|"The leisure group consists in 32 stimulating and socializing group activities (e.g., card games, board games, coffee & talk, geography review, etc.)without specific goals."
834579|NCT01279070|O1|Outcome|REPYFLEC Cognitive Remediation Group Training|REPYFLEC CR is a strategy-based training that targets executive function and metacognition. It is carried out using paper and pencil and a blackboard (required to develop some of the tasks, explanations, examples, etc.); in a group format (4-6 participants), over 4 months twice a week and consisting of 32 sessions lasting 1 h. We developed a Spanish manual where training is described session by session; incorporating the materials for developing sessions, some theoretical points and bibliography for therapists. Working contents are divided into two main areas: Problem Solving (PS) and Cognitive Flexibility (CF). In the PS module (16 sessions), training in executive function,thinking processes and self-monitoring was emphasized.In the CF module (16 sessions), all the tasks require practice of cognitive flexibility combined with other executive abilities such as planning or self-monitoring.
834580|NCT01279070|E2|Reported Event|Repyflec Training|Cognitive remediation group treatment based on Problem Solving and Cognitive Flexibility
834581|NCT01279070|E1|Reported Event|Leisure Group|Stimulating activities without specific goals and focused on leisure
834582|NCT01279044|B4|Baseline|Total|Total of all reporting groups
834583|NCT01279044|B3|Baseline|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834584|NCT01279044|B2|Baseline|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834585|NCT01279044|B1|Baseline|Phase 1 - Formative Research|Formative research through individual interviews and pilot testing to develop and adapt the key elements of Personal Cognitive Counseling
834586|NCT01279044|P3|Participant Flow|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834587|NCT01279044|P2|Participant Flow|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834588|NCT01279044|P1|Participant Flow|Formative Phase 1|Individual interviews and pilot testing to develop and adapt key elements of Personal Cognitive Counseling
834589|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834813|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834590|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834591|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834592|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834593|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834594|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834595|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834596|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834597|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834598|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834599|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834600|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834601|NCT01279044|O2|Outcome|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834602|NCT01279044|O1|Outcome|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834603|NCT01279044|E2|Reported Event|HIV Testing With Information Only|Standard HIV testing with information only: Standard HIV testing with information only
834604|NCT01279044|E1|Reported Event|HIV Testing With Adapted Personalized Cognitive Risk-reduction|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC): The individualized, cognitive counseling intervention was designed to help participants address the self-justifications—beliefs, thoughts, and attitudes—that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
834605|NCT01278953|B3|Baseline|Total|Total of all reporting groups
834606|NCT01278953|B2|Baseline|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834607|NCT01278953|B1|Baseline|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834608|NCT01278953|P2|Participant Flow|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834609|NCT01278953|P1|Participant Flow|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834610|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834611|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834612|NCT01278953|O2|Outcome|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834613|NCT01278953|O1|Outcome|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834614|NCT01278953|E2|Reported Event|Control|"Ablation performed using a catheter with no contact force sensing capability~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834650|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834615|NCT01278953|E1|Reported Event|TactiCath|"Ablation performed using the TactiCath contact force sensing catheter~Catheter ablation for the treatment of paroxysmal atrial fibrillation: A pulmonary vein isolation procedure will be performed using radiofrequency ablation."
834616|NCT01278927|B5|Baseline|Total|Total of all reporting groups
834617|NCT01278927|B4|Baseline|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834618|NCT01278927|B3|Baseline|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834619|NCT01278927|B2|Baseline|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834620|NCT01278927|B1|Baseline|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834621|NCT01278927|P4|Participant Flow|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834622|NCT01278927|P3|Participant Flow|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834623|NCT01278927|P2|Participant Flow|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834624|NCT01278927|P1|Participant Flow|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834625|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834626|NCT01278927|O3|Outcome|Exercise and Stress Management|Exercise and Stress Management - Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834627|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834629|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834630|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834631|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834632|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834633|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834634|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834635|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834636|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834637|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834638|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834639|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834640|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834641|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834642|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834643|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834644|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834645|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834646|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834647|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834648|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834651|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834652|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834653|NCT01278927|O4|Outcome|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
834654|NCT01278927|O3|Outcome|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
834655|NCT01278927|O2|Outcome|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
834656|NCT01278927|O1|Outcome|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
834657|NCT01278927|E4|Reported Event|Standard Care|"Patients randomized to standard care only will be informed of their assigned condition and receive a digital video disc (DVD). The interventionist will briefly discuss the topics of the DVD and elicit questions. To minimize contamination across intervention conditions, participants randomized to the control group will be provided with only general advice about exercise and stress management during treatment (i.e., to maintain any usual patterns of exercise to the extent possible and to continue using any techniques they currently use to manage stress).~Standard Care: Patients randomized to standard care only will be informed of their assigned condition and receive the DVD."
834658|NCT01278927|E3|Reported Event|Exercise and Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions. On Day 30 post HCT, the same interventionist will meet with the participant briefly to answer any questions about the interventions, encourage the continued use of the interventions as recommended, and monitor for any adverse reactions. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Exercise and Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions."
834826|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834659|NCT01278927|E2|Reported Event|Stress Management|"Participants will receive a packet of materials from the study interventionist, along with a brief standardized introduction to the self-administered intervention. On Day 30 post HCT, the interventionist will meet with the participant to answer any questions about the intervention, encourage the continued use of stress management techniques as recommended, and monitor for any adverse reactions to use of the techniques. The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant. Whenever possible, the interventionist meeting with the patient at 30 and 60 days should be the same interventionist who previously met with the patient.~Stress Management: Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention."
834660|NCT01278927|E1|Reported Event|Exercise|"Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief (10 minute) personalized introduction to the home-based exercise intervention. On Day 30 post hematopoietic cell transplantation (HCT), participants will meet briefly with the same interventionist when possible. To minimize contamination across intervention conditions, participants randomized to Exercise will be provided with only general advice regarding stress management (i.e., to continue using any techniques they currently use to manage stress). The interventionist will meet with the patient again in person or by phone at approximately 60 days post transplant.~Exercise: Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention."
834661|NCT01278797|B1|Baseline|Entire Study Population|Includes all subjects randomized to either treatment sequence
834662|NCT01278797|P2|Participant Flow|Telm 80 mg + Amlo 10 mg First, Then Telm/Amlo 80 mg/10 mg|Individual components followed by Combination tablet
834663|NCT01278797|P1|Participant Flow|Telm/Amlo 80 mg/10 mg First, Then Telm 80 mg + Amlo 10 mg|Combination tablet followed by individual components
834664|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
834665|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
834666|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
834667|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
834668|NCT01278797|O2|Outcome|Telm 80 mg + Amlo 10 mg|Individual tablets
834669|NCT01278797|O1|Outcome|Telm/Amlo 80 mg/10 mg|Combination tablet
834670|NCT01278797|E2|Reported Event|Telm 80 mg + Amlo 10 mg|Individual tablets
834671|NCT01278797|E1|Reported Event|Telm/Amlo 80 mg/10 mg|Combination tablet
834672|NCT01278745|B3|Baseline|Total|Total of all reporting groups
834673|NCT01278745|B2|Baseline|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834712|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834814|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834674|NCT01278745|B1|Baseline|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834675|NCT01278745|P4|Participant Flow|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
834676|NCT01278745|P3|Participant Flow|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
834677|NCT01278745|P2|Participant Flow|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834720|NCT01278485|P1|Participant Flow|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834721|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834880|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
834678|NCT01278745|P1|Participant Flow|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834679|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834680|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834681|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834682|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834683|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834684|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834685|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834722|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
835906|NCT01274897|E2|Reported Event|Placebo|Subjects received the saline placebo.
834686|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834687|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834688|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834689|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834690|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834691|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834713|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834815|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834692|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834693|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834694|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834695|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834696|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834697|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834698|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834699|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834714|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834849|NCT01278160|B3|Baseline|Total|Total of all reporting groups
834700|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834701|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834702|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834703|NCT01278745|O2|Outcome|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834704|NCT01278745|O1|Outcome|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834705|NCT01278745|E4|Reported Event|Discontinued Pre-Randomization|Subjects that were enrolled and transplanted on study, but withdrew from the study prior to randomization.
834706|NCT01278745|E3|Reported Event|Discontinued Pre-Transplant|Subjects that enrolled, but withdrew from the study prior to their transplant.
834707|NCT01278745|E2|Reported Event|Placebo|Induction: Rituximab Placebo was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834708|NCT01278745|E1|Reported Event|Rituximab|Induction: Rituximab was administered in 2 1000 mg doses on Day 0 and Day 12 (+/- 2 days). Maintenance: Mycophenolate Mofetil (MMF) was given at a starting dose of 2-3 g by mouth or intravenously per day in 2 or 3 divided doses. Investigator could choose an alternative treatment if needed. Methylprednisolone/Prednisone dosing was administered according to the local center standard. After 6 months, prednisone was withdrawn at the discretion of the investigator. The suggested oral prednisone taper was Day 14: 20 mg/day by mouth, Day 30: 15 mg/day by mouth, Day 90: 10 mg/day by mouth, Day 180: 5 mg/day by mouth, and greater than Day 180: 0-5 mg/day by mouth. Tacrolimus, was administered per site standards to attain target trough levels. The target whole blood tacrolimus concentrations were as follows: Day 1-30 post transplant 10-20 ng/mL and Day 31-Month 12 5-15 ng/mL.
834709|NCT01278615|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834710|NCT01278615|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834711|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
835304|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
834715|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834716|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834717|NCT01278615|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834718|NCT01278615|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID on days 1-28. Treatment repeats every 28 days for 8 courses in the absence of disease progression or unacceptable toxicity~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
834719|NCT01278485|B1|Baseline|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834881|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
834882|NCT01277861|O2|Outcome|Saline Pretreatment Group|
834723|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834724|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834725|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834726|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834727|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834728|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834729|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834730|NCT01278485|O1|Outcome|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834731|NCT01278485|E1|Reported Event|Adults With Type 2 Diabetes Mellitus ≥30 Years of Age|Adults with Type 2 diabetes mellitus ≥30 years of age who have been treated with sulphonylurea (SU) monotherapy or SU+ metformin (MF) combination therapy for at least 6 months by a cardiologist, nephrologist, or family practice doctor.
834732|NCT01278407|B4|Baseline|Total|Total of all reporting groups
834733|NCT01278407|B3|Baseline|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
834734|NCT01278407|B2|Baseline|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
834735|NCT01278407|B1|Baseline|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
834736|NCT01278407|P5|Participant Flow|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
834737|NCT01278407|P4|Participant Flow|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
834785|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
834738|NCT01278407|P3|Participant Flow|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
834739|NCT01278407|P2|Participant Flow|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
834740|NCT01278407|P1|Participant Flow|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
834741|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
834742|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
834743|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
834744|NCT01278407|O3|Outcome|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
834745|NCT01278407|O2|Outcome|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
834746|NCT01278407|O1|Outcome|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
834883|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|
834747|NCT01278407|E5|Reported Event|Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil (5 mg or 10 mg) up to Week 12 in the Confirmatory Phase, maintained allocated treatment and dosages until Week 24. In the 5 mg group of the Confirmatory Phase, the dose was increased to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
834748|NCT01278407|E4|Reported Event|Placebo to Donepezil (5 +10 mg) - Extension Phase|Participants previously receiving donepezil matched placebo up to Week 12 in the Confirmatory Phase, continued placebo until Week 16 (at the beginning of the Extension Phase). Participants received 3 mg of donepezil, and the dose was then increased to 5 mg at Week 18 and to 10 mg at Week 24. After Week 24, dose reduction to 5 mg was allowed if continuation at 10 mg caused any safety concerns.
834749|NCT01278407|E3|Reported Event|Donepezil 10 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 4 weeks. Thereafter, the dose was increased to 10 mg for 6 weeks in the confirmatory phase.
834750|NCT01278407|E2|Reported Event|Donepezil 5 mg - Confirmatory Phase|Participants received donepezil tablets orally, once daily for 12 weeks. Treatment began with 3 mg for 2 weeks, and then the dose was increased to 5 mg for 10 weeks in the confirmatory phase.
834751|NCT01278407|E1|Reported Event|Placebo - Confirmatory Phase|Participants received donepezil matched placebo tablets orally, once daily for 12 weeks in the confirmatory phase.
834752|NCT01278394|B1|Baseline|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834753|NCT01278394|P1|Participant Flow|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834754|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834755|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834756|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834757|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834758|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834759|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834760|NCT01278394|O1|Outcome|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834761|NCT01278394|E1|Reported Event|AN2690 Solution, 5.0%|AN2690 Solution, 5.0%: Once daily application for 360 days
834762|NCT01278342|B4|Baseline|Total|Total of all reporting groups
834763|NCT01278342|B3|Baseline|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
834764|NCT01278342|B2|Baseline|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
834765|NCT01278342|B1|Baseline|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
834766|NCT01278342|P3|Participant Flow|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
834767|NCT01278342|P2|Participant Flow|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
834768|NCT01278342|P1|Participant Flow|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
834769|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
834770|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
834771|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
834824|NCT01277042|O2|Outcome|Engerix-B Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834772|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
834773|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
834774|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
834775|NCT01278342|O3|Outcome|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
834776|NCT01278342|O2|Outcome|Sandostatin LAR High Dose + Pegvisomat|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
834777|NCT01278342|O1|Outcome|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months.
834778|NCT01278342|E3|Reported Event|Sandostatin LAR High Dose + Cabergoline|"All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Cabergoline for a further 4 months, with Cabergoline doses as follows:~1st week: 0.25 mg twice a week (0.50 mg/week)~2nd week: 0.50 mg/week twice a week (1 mg/week)~3rd week: 0.50 mg four times a week (2 mg/week)~4th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
834779|NCT01278342|E2|Reported Event|Sandostatin LAR High Dose + Pegvisomant|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with uncontrolled GH and/or IGF-I, were randomized to receive Sandostatin LAR 40 mg every 28 days in combination with weekly doses of Pegvisomant 70 mg subcutaneously (s.c.) for a further 4 months.
834780|NCT01278342|E1|Reported Event|Sandostatin LAR High Dose Alone|All patients were treated with Sandostatin LAR 40 mg i.m. every 28 days for 3 months. Following biochemical assessment, patients with controlled GH and IGF-I after 3 months of Sandostatin LAR monotherapy continued to receive Sandostatin LAR 40 mg i.m. every 28 days for an additional 4 months
834781|NCT01278303|B1|Baseline|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
834782|NCT01278303|P1|Participant Flow|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
834783|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
834784|NCT01278303|O1|Outcome|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
834786|NCT01278303|E1|Reported Event|Treatment of Aortic Wall Injury|"Repair of aortic wall injury with covered CP Stents~Treatment of Aortic Wall Injury: A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients."
834787|NCT01277211|B3|Baseline|Total|Total of all reporting groups
834788|NCT01277211|B2|Baseline|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
834789|NCT01277211|B1|Baseline|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
834790|NCT01277211|P2|Participant Flow|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
834791|NCT01277211|P1|Participant Flow|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
834825|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834792|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
834793|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
834794|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
834795|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
834796|NCT01277211|O2|Outcome|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
834797|NCT01277211|O1|Outcome|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
834798|NCT01277211|E2|Reported Event|DRSP-EE|Participants were to complete 13 cycles of drospirenone (DRSP) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received a total of 21 tablets of DRSP-EE per cycle. Each tablet contained 3 mg DRSP and 30 μg EE.
834799|NCT01277211|E1|Reported Event|ENG-EE (NuvaRing)|Participants were to complete 13 cycles of etonogestrel (ENG) and ethinylestradiol (EE) use. Each cycle was 28 days, with a 21-day active treatment period followed by a 7-day ring-free period. Participants used one ring per cycle. Each ring contained 11.7 mg ENG and 2.7 mg EE, and released on average 120 mcg/day of ENG and 15 mcg/day of EE.
834800|NCT01277081|B3|Baseline|Total|Total of all reporting groups
834801|NCT01277081|B2|Baseline|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834802|NCT01277081|B1|Baseline|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834803|NCT01277081|P2|Participant Flow|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834804|NCT01277081|P1|Participant Flow|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 milligram (mg) of paracetamol in 200 milliliter (mL) of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834805|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834806|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834807|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834808|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834809|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834810|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834811|NCT01277081|O2|Outcome|Paracetamol Tablet|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834812|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834816|NCT01277081|O1|Outcome|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834817|NCT01277081|E2|Reported Event|Paracetamol Tablets|Paracetamol 500 mg tablet was taken orally with measured 200 mL of ambient mineral water.
834818|NCT01277081|E1|Reported Event|Mentholated Paracetamol Hot Drink|Mentholated paracetamol hot drink prepared by dissolving 500 mg of paracetamol in 200 mL of boiled mineral water was taken orally by participants within a time period of 15 minutes.
834819|NCT01277042|B3|Baseline|Total|Total of all reporting groups
834820|NCT01277042|B2|Baseline|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834821|NCT01277042|B1|Baseline|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834822|NCT01277042|P2|Participant Flow|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834823|NCT01277042|P1|Participant Flow|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834884|NCT01277861|O2|Outcome|Saline Pretreatment Group|Saline 10 ml prior to induction of anesthesia.
834827|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834828|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834829|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834830|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834831|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834832|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834833|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834834|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834835|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834836|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834837|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834838|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834839|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834840|NCT01277042|O2|Outcome|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834841|NCT01277042|O1|Outcome|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834842|NCT01277042|E2|Reported Event|Engerix Group|Subjects received a 3-dose vaccination course of the Engerix™-B vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834843|NCT01277042|E1|Reported Event|Cervarix Group|Subjects received a 3-dose vaccination course of the Cervarix™ vaccine administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
834844|NCT01278173|B1|Baseline|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
834845|NCT01278173|P1|Participant Flow|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
834846|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
834847|NCT01278173|O1|Outcome|Sabril|Vigabatrin, 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
834848|NCT01278173|E1|Reported Event|Vigabatrin|
834850|NCT01278160|B2|Baseline|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834851|NCT01278160|B1|Baseline|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834852|NCT01278160|P2|Participant Flow|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834853|NCT01278160|P1|Participant Flow|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834854|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834885|NCT01277861|O1|Outcome|Fentanyl Pretreatment Group|Fentanyl 1 µg/kg (constituted to 10 ml with saline) prior to induction of anesthesia.
834886|NCT01277861|E2|Reported Event|SALINE|SALINE
834887|NCT01277861|E1|Reported Event|FENTANYL|FENTANYL
834855|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834856|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834857|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834858|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834859|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834860|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834861|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834862|NCT01278160|O2|Outcome|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834863|NCT01278160|O1|Outcome|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834864|NCT01278160|E2|Reported Event|BIAsp 30 (1:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 1/2 and 1/2 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834865|NCT01278160|E1|Reported Event|BIAsp 30 (2:1)|After discontinuation of previous treatment of once daily biphasic insulin aspart 30 (BIAsp 30) or insulin glargine combined with metformin and glimepiride in trial BIAsp-3756, subjects were adminstered BIAsp 30 twice daily with initial dosage split regimen of 2/3 and 1/3 total daily dose before breakfast and before dinner, respectively combined with metformin administered orally with meals
834866|NCT01278030|B3|Baseline|Total|Total of all reporting groups
834867|NCT01278030|B2|Baseline|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
835033|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
834868|NCT01278030|B1|Baseline|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
834869|NCT01278030|P2|Participant Flow|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
834870|NCT01278030|P1|Participant Flow|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
834871|NCT01278030|O2|Outcome|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
834872|NCT01278030|O1|Outcome|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
834873|NCT01278030|E2|Reported Event|Control|Patients will be implanted according to the standard of care with the Left Ventricular lead in the traditional Left Ventricular lead position.
834874|NCT01278030|E1|Reported Event|3D Echo-guided LV Lead Placement|The location of the site of latest mechanical activation based on 3-D Echo will be available to the physician from the core lab analysis. This location will be used as the target for optimal Left Ventricular lead placement.
834875|NCT01277861|B3|Baseline|Total|Total of all reporting groups
834876|NCT01277861|B2|Baseline|SALINE|SALINE
834877|NCT01277861|B1|Baseline|FENTANYL|FENTANYL
834878|NCT01277861|P2|Participant Flow|SALINE|SALINE
834879|NCT01277861|P1|Participant Flow|FENTANYL|FENTANYL
834888|NCT01277822|B3|Baseline|Total|Total of all reporting groups
834889|NCT01277822|B2|Baseline|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834890|NCT01277822|B1|Baseline|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834891|NCT01277822|P2|Participant Flow|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834892|NCT01277822|P1|Participant Flow|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834893|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834894|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834895|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834896|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834897|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834898|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834899|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834900|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834901|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834902|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834903|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834904|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
835348|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
834905|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834906|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834907|NCT01277822|O2|Outcome|Amlodipine|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834908|NCT01277822|O1|Outcome|Losartan/Amlodipine|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks.
834909|NCT01277822|E2|Reported Event|Amlodipine 10mg|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks. Participants will also receive 1 tablet of placebo for combination losartan/amlodipine orally, once daily for 8 weeks.
834910|NCT01277822|E1|Reported Event|Losartan 100mg/Amlodipine 5mg|One combination tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks. Participants will also receive 2 tablets of placebo for amlodipine 5mg orally, once daily for 8 weeks
834911|NCT01277757|B1|Baseline|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
834912|NCT01277757|P1|Participant Flow|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
834913|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
834914|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
834915|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
834916|NCT01277757|O1|Outcome|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
834917|NCT01277757|E1|Reported Event|Akt Inhibitor MK-2206|Akt Inhibitor MK-2206 orally once a week on days 1, 8, 15, and 22. Starting dose 200 mg, courses repeat every 28 days.
834918|NCT01277718|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
834919|NCT01277718|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. Treatment B in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. There was minimum of a 13-day washout between cobimetinib doses of each period.
834920|NCT01277718|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A in Period 1: One 20-mg tablet of cobimetinib administered orally with 240 milliliters (mL) room temperature water after at least an 8-hour fast. Treatment B in Period 2: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast. Treatment C in Period 3: 20 mg oral rabeprazole administered once daily for 4 days starting on Day -4. On Day 1, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized Food and Drug Administration (FDA) high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water. There was minimum of a 13-day washout between cobimetinib doses of each period.
834921|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
834922|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
834923|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
834924|NCT01277718|O3|Outcome|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
834925|NCT01277718|O2|Outcome|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
834926|NCT01277718|O1|Outcome|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
834962|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
835034|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
834927|NCT01277718|E3|Reported Event|Cobimetinib [Fed] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state. Approximately 30 minutes later, participants were provided a standardized FDA high-fat meal, and approximately 30 minutes after starting the meal, one 20-mg tablet of cobimetinib was administered orally with 240 mL room temperature water.
834928|NCT01277718|E2|Reported Event|Cobimetinib [Fasted] + Rabeprazole|Participants received 20 mg oral rabeprazole once daily for 4 days starting on Day -4. On Day 1 of the treatment period, 20 mg rabeprazole was administered in fasted state followed by one 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
834929|NCT01277718|E1|Reported Event|Cobimetinib [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
834930|NCT01277601|B5|Baseline|Total|Total of all reporting groups
834931|NCT01277601|B4|Baseline|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
834932|NCT01277601|B3|Baseline|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
834933|NCT01277601|B2|Baseline|TDF 48 Weeks + Peg-IFN 16 Week|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
834934|NCT01277601|B1|Baseline|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
834935|NCT01277601|P4|Participant Flow|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
834936|NCT01277601|P3|Participant Flow|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
834937|NCT01277601|P2|Participant Flow|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
834938|NCT01277601|P1|Participant Flow|TDF+Peg-IFN 48 Weeks|Tenofovir disoproxil fumarate (TDF) 300 mg tablet once daily plus peginterferon α-2a (Peg-IFN) 180 µg subcutaneous (s.c.) injection once weekly for 48 weeks
834939|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
834940|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
834941|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
836068|NCT01273623|O2|Outcome|Post-atherectomy|after Jetstream use and prior to adjunctive therapies
834942|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834943|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834944|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834945|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834946|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834947|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834948|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834949|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834950|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834951|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834952|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834953|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834954|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834955|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834956|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834957|NCT01277601|O6|Outcome|Peg-IFN 48 Week (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834958|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834959|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834960|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834961|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834963|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834964|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834965|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834966|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834967|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834968|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834969|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834970|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834971|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834972|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834973|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834974|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834975|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834976|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834977|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834978|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834979|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834980|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834981|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834982|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834983|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834984|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834985|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834986|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834987|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834988|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834989|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834990|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834991|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834992|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834993|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
834994|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834995|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
834996|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834997|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
834998|NCT01277601|O7|Outcome|Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
834999|NCT01277601|O6|Outcome|Peg-IFN 48 Weeks (Not Retreated)|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
835000|NCT01277601|O5|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks. Participants in this group were not eligible to enter the retreatment phase.
835001|NCT01277601|O4|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
835002|NCT01277601|O3|Outcome|TDF 48 Weeks + Peg-IFN 16 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks in the initial treatment phase
835003|NCT01277601|O2|Outcome|TDF+Peg-IFN 48 Weeks (Retreated)|Following the randomized treatment, participants who met protocol-specified criteria were retreated with TDF 300 mg tablet once daily up to Week 120 in the retreatment phase.
835004|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Week (Not Retreated)|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks in the initial treatment phase
835005|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
835006|NCT01277601|O3|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
835007|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
835008|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
835009|NCT01277601|O4|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
835010|NCT01277601|O3|Outcome|TDF 120 Week|TDF 300 mg tablet once daily for 120 weeks
835451|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835011|NCT01277601|O2|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
835012|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
835013|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
835014|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
835015|NCT01277601|O1|Outcome|TDF 48 Weeks + Peg-IFN 16 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks
835016|NCT01277601|O3|Outcome|Peg-IFN 48 Weeks|Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
835017|NCT01277601|O2|Outcome|TDF 120 Weeks|TDF 300 mg tablet once daily for 120 weeks
835018|NCT01277601|O1|Outcome|TDF+Peg-IFN 48 Weeks|TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks
835019|NCT01277601|E7|Reported Event|Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring during the retreatment phase (from start of retreatment up to Week 120 plus 30 days).~TDF 300 mg tablet once daily up to Week 120"
835020|NCT01277601|E6|Reported Event|Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
835021|NCT01277601|E5|Reported Event|TDF 120 Weeks|"Adverse events in this reporting group are those occurring during the initial treatment phase (up to 120 weeks plus 30 days).~TDF 300 mg tablet once daily for up to 120 weeks"
835022|NCT01277601|E4|Reported Event|TDF 48 Weeks + Peg-IFN 16 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
835023|NCT01277601|E3|Reported Event|TDF 48 Week + Peg-IFN 16 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 16 weeks followed by TDF 300 mg tablet once daily for an additional 32 weeks"
835024|NCT01277601|E2|Reported Event|TDF+Peg-IFN 48 Weeks (Retreated)|"Adverse events in this reporting group are those occurring after TDF retreatment through last TDF retreatment dose plus 30 days.~TDF 300 mg tablet once daily up to Week 120"
835025|NCT01277601|E1|Reported Event|TDF+Peg-IFN 48 Weeks (Not Retreated)|"Adverse events in this reporting group are those occurring in participants who were not retreated or before retreatment through last non-retreatment dose plus 30 days.~TDF 300 mg tablet once daily plus Peg-IFN 180 µg s.c. injection once weekly for 48 weeks"
835026|NCT01277549|B3|Baseline|Total|Total of all reporting groups
835027|NCT01277549|B2|Baseline|Nonmobilized Donors|Donors not mobilized prior to MNC collection
835028|NCT01277549|B1|Baseline|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
835029|NCT01277549|P2|Participant Flow|Non-mobilized Donors|In this arm, donors were not mobilized prior to mononuclear cell collection. Only collection efficiency of mononuclear cells could be assessed as CD34+ cells are not present in this population.
835030|NCT01277549|P1|Participant Flow|G-CSF Mobilized Donors|In this arm the donors received G-CSF (granulocyte colony stimulating factor) prior to the MNC (mononuclear cell) collection. G-CSF causes the mobilization of hematopoetic stem cells which are CD34 (cluster of differentiation 34) + to the peripheral blood. Collection efficiency of all mononuclear cells and of the CD34+ subset of mononuclear cells was assessed.
835031|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
835032|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
835035|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
835036|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
835037|NCT01277549|O2|Outcome|Nonmobilized Donors|In this arm, donors were not mobilized prior to collection.
835038|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|In this arm, donors were mobilized with G-CSF prior to collection.
835039|NCT01277549|O2|Outcome|Nonmobilized Donors|Donors were not mobilized prior to MNC collection.
835040|NCT01277549|O1|Outcome|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection.
835041|NCT01277549|E2|Reported Event|Nonmobilized Donors|"Donors not mobilized prior to MNC collection. Note that some Adverse Events (Flu-like symptoms, Muscle Aches, and Bone Pain) apply only to G-CSF mobilized donors. Nonmobilized donors were not assessed for these adverse events as they were not at risk."
835042|NCT01277549|E1|Reported Event|G-CSF Mobilized Donors|Donors received G-CSF prior to MNC collection
835043|NCT01277523|B4|Baseline|Total|Total of all reporting groups
835044|NCT01277523|B3|Baseline|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835045|NCT01277523|B2|Baseline|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835046|NCT01277523|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835047|NCT01277523|P3|Participant Flow|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835048|NCT01277523|P2|Participant Flow|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835049|NCT01277523|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835050|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835051|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835052|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835053|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835054|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835055|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835056|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835057|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835058|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835059|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835060|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835061|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835062|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835063|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835064|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835065|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835066|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835067|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835068|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835069|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835070|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835071|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835072|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835073|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835187|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835074|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835075|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835076|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835077|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835078|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835079|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835080|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835081|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835082|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835083|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835084|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835085|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835086|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835087|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835129|NCT01277354|O1|Outcome|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
835088|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835089|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835090|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835091|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835092|NCT01277523|O3|Outcome|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835093|NCT01277523|O2|Outcome|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835094|NCT01277523|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835095|NCT01277523|E3|Reported Event|Tio R5|Inhalation of 5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835096|NCT01277523|E2|Reported Event|Tio R2.5|Inhalation of 2.5mcg tiotropium bromide solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835097|NCT01277523|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 12 weeks delivered by the Respimat Inhaler, as add on therapy on top of usual care.
835098|NCT01277510|B3|Baseline|Total|Total of all reporting groups
835099|NCT01277510|B2|Baseline|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835100|NCT01277510|B1|Baseline|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835101|NCT01277510|P2|Participant Flow|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835102|NCT01277510|P1|Participant Flow|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835176|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
835188|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835103|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835104|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835105|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835106|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835107|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835108|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835109|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835110|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835111|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835112|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835113|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835114|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835115|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835177|NCT01276847|E3|Reported Event|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
835178|NCT01276847|E2|Reported Event|No Treatment|No treatment administered
835116|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835117|NCT01277510|O2|Outcome|Cinacalcet|Participants received standard of care and cinacalcet once daily for 30 weeks during the double-blind phase. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks until Week 24 to a maximum dose of 4.2 mg/kg. During the open-label phase participants continued to receive cinacalcet with standard of care for an additional 30 weeks. Regardless of the titration level reached at the last dose of IP in the double-blind phase, all participants started titration at ≤ 0.20 mg/kg based on dry weight.
835118|NCT01277510|O1|Outcome|Placebo|Participants received standard of care and placebo once daily for 30 weeks during the double-blind phase. During the open-label phase, participants received cinacalcet with standard of care for an additional 30 weeks. The starting dose of cinacalcet was ≤ 0.20 mg/kg based on dry weight, and could be titrated up according to plasma iPTH and serum calcium levels every 4 weeks up to Week 54 to a maximum dose of 4.2 mg/kg.
835119|NCT01277510|E4|Reported Event|Open-label Phase: Previous Cinacalcet|
835120|NCT01277510|E3|Reported Event|Open-label Phase: Previous Placebo|
835121|NCT01277510|E2|Reported Event|Double-blind Phase: Cinacalcet|
835122|NCT01277510|E1|Reported Event|Double-blind Phase: Placebo|
835123|NCT01277354|B3|Baseline|Total|Total of all reporting groups
835124|NCT01277354|B2|Baseline|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
835125|NCT01277354|B1|Baseline|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
835126|NCT01277354|P2|Participant Flow|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
835127|NCT01277354|P1|Participant Flow|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
835128|NCT01277354|O2|Outcome|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
835130|NCT01277354|E2|Reported Event|Waitlist Group|Participants come in at the end of weeks 2, 4, and 6 to complete ratings but do not receive therapy.
835131|NCT01277354|E1|Reported Event|CPT Group|Participants are seen weekly for six weeks for therapy. At visits 2, 4, and 6 they also complete ratings.
835132|NCT01277302|B4|Baseline|Total|Total of all reporting groups
835133|NCT01277302|B3|Baseline|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835134|NCT01277302|B2|Baseline|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835135|NCT01277302|B1|Baseline|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835136|NCT01277302|P3|Participant Flow|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835137|NCT01277302|P2|Participant Flow|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835138|NCT01277302|P1|Participant Flow|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835139|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835140|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835179|NCT01276847|E1|Reported Event|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
835180|NCT01276821|B3|Baseline|Total|Total of all reporting groups
835181|NCT01276821|B2|Baseline|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835141|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835142|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835143|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835144|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835145|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835146|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835230|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835147|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835148|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835149|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835150|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835151|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835152|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835153|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835154|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835155|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835182|NCT01276821|B1|Baseline|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835183|NCT01276821|P2|Participant Flow|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835184|NCT01276821|P1|Participant Flow|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835156|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835157|NCT01277302|O3|Outcome|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835158|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835159|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835160|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835231|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835232|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835161|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835162|NCT01277302|O2|Outcome|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835163|NCT01277302|O1|Outcome|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835164|NCT01277302|E3|Reported Event|Ranibizumab 0.5 mg Monthly - Non-randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections and then never met the study-specific VA-OCT stability criteria from month 7 to month 14. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835165|NCT01277302|E2|Reported Event|Ranibizumab 0.5 mg PRN - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific VA-OCT stability criteria were met and randomization occurred to the PRN arm and no injection was given. At subsequent monthly visits after randomization, injections were given if the VA-OCT stability criteria were not met and no injections were given if the VA-OCT stability criteria were met. Subjects could receive between 7 and a maximum of 14 ranibizumab 0.5 mg injections.
835166|NCT01277302|E1|Reported Event|Ranibizumab 0.5 mg Monthly - Randomized Subjects|Subjects received at least 7 monthly intravitreal ranibizumab 0.5 mg injections until the first month where the study-specific visual acuity and spectral-domain optical coherence tomography (VA-OCT) stability criteria were met and randomization occurred to the monthly arm. At subsequent monthly visits after randomization, injections were given whether the VA-OCT stability criteria were met or not met. Subjects were to receive 15 ranibizumab 0.5 mg injections.
835167|NCT01276847|B4|Baseline|Total|Total of all reporting groups
835168|NCT01276847|B3|Baseline|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
835169|NCT01276847|B2|Baseline|No Treatment|No treatment administered
835170|NCT01276847|B1|Baseline|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
835171|NCT01276847|P3|Participant Flow|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
835172|NCT01276847|P2|Participant Flow|No Treatment|No treatment administered
835173|NCT01276847|P1|Participant Flow|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
835174|NCT01276847|O1|Outcome|Etanercept|Etanercept : Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
835175|NCT01276847|O1|Outcome|Ustekinumab|Ustekinumab : Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
835185|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835186|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835189|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835190|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835191|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835192|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835193|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835194|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835195|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835196|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835197|NCT01276821|O2|Outcome|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835198|NCT01276821|O1|Outcome|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835199|NCT01276821|E2|Reported Event|Study|Nebulisation with 4ml of Hypertonic Saline (3%) and 1.5ml of L-Epinephrine
835200|NCT01276821|E1|Reported Event|Standard|Nebulisation with 4ml of 0.9% Normal Saline and 1.5ml of L-Epinephrine
835201|NCT01276756|B3|Baseline|Total|Total of all reporting groups
835202|NCT01276756|B2|Baseline|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835203|NCT01276756|B1|Baseline|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
836069|NCT01273623|O1|Outcome|Pre-atherectomy|prior to Jetstream use
835204|NCT01276756|P2|Participant Flow|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835205|NCT01276756|P1|Participant Flow|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835206|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835207|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835208|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835209|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835210|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835211|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835212|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835213|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835214|NCT01276756|O2|Outcome|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835215|NCT01276756|O1|Outcome|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835216|NCT01276756|E2|Reported Event|Triple Therapy|Group B: comprises 50 treatment-naive chronic HCV patients who will receive oral Nitazoxanide 500 mg twice daily for 4 weeks (lead-in phase) followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835217|NCT01276756|E1|Reported Event|Standard of Care|Group A: comprises 50 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks.
835218|NCT01276639|B4|Baseline|Total|Total of all reporting groups
835219|NCT01276639|B3|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835220|NCT01276639|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835221|NCT01276639|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835222|NCT01276639|P5|Participant Flow|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835223|NCT01276639|P4|Participant Flow|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835224|NCT01276639|P3|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835225|NCT01276639|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835226|NCT01276639|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 (tofacitinib) 5 milligram (mg) tablet orally twice daily up to Week 52.
835227|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835228|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835229|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835234|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835235|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835236|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835237|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835238|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835239|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835240|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835241|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835242|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835243|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835244|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835245|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835246|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835247|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835248|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835249|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835250|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835251|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835252|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835253|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835254|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835255|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835256|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835257|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835258|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835259|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835260|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835261|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835262|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835263|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835264|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835265|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835266|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835267|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835268|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835269|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835270|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835271|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835272|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835273|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835274|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835275|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835276|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835277|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
836070|NCT01273623|E1|Reported Event|Study Participants|
835278|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835279|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835280|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835281|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835282|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835283|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835284|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835285|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835286|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835287|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835288|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835289|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835290|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835291|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835292|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835293|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835294|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835295|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835296|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835297|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835298|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835299|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835300|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835301|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835302|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835303|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835305|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835306|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835307|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835308|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835309|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835310|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835311|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835312|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835313|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835314|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835315|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835316|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835317|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835318|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835319|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835320|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835321|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835322|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835323|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835324|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835325|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835326|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835327|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835328|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835329|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835330|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835331|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835332|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835333|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835334|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835335|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835336|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835337|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835338|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835339|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835340|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835341|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835342|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835343|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835344|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835345|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835346|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835347|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835349|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835350|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835351|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835352|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835353|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835354|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835355|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835356|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835357|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835358|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835359|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835360|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835361|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835362|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835363|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835364|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835365|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835366|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835367|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835368|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835369|NCT01276639|O4|Outcome|Placebo, CP-690,550 10 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835370|NCT01276639|O3|Outcome|Placebo, CP-690,550 5 mg|Participants who were re-assigned to this group from placebo at Week 16 and thereafter received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835371|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835372|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835373|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835374|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835375|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835376|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835377|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835378|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835379|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835380|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835381|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835382|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835383|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835384|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835385|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835386|NCT01276639|O2|Outcome|CP-690,550 10 mg|Participants who received CP-690,550 10 mg tablet orally twice daily up to Week 52.
835387|NCT01276639|O1|Outcome|CP-690,550 5 mg|Participants who received CP-690,550 5 mg tablet orally twice daily up to Week 52.
835388|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835389|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835390|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835391|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835392|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835393|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835428|NCT01276509|B3|Baseline|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835394|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835395|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835396|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835397|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835398|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835399|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835400|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835401|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835402|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835403|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835404|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835405|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835406|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835407|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835408|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835409|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835410|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835411|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835452|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835412|NCT01276639|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16. Participants in this group were re-randomized to CP-690,550 5 mg or CP-690,550 10 mg treatment at Week 16.
835413|NCT01276639|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835414|NCT01276639|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835415|NCT01276639|E5|Reported Event|Placebo|Participants who received placebo matched to CP-690,550 tablet orally twice daily up to Week 16 but were not re-randomized to CP-690,550 treatment.
835416|NCT01276639|E4|Reported Event|Placebo, CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 10 mg tablet orally twice daily up to Week 52.
835417|NCT01276639|E3|Reported Event|Placebo, CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Week 16 and thereafter CP-690,550 5 mg tablet orally twice daily up to Week 52.
835418|NCT01276639|E2|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 52.
835419|NCT01276639|E1|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 52.
835420|NCT01276535|B1|Baseline|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
835421|NCT01276535|P1|Participant Flow|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
835422|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
835423|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
835424|NCT01276535|O1|Outcome|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
835425|NCT01276535|E1|Reported Event|Erchonia MLS & Erchonia THL|"The Erchonia® MLS contains 5 independent diodes: 4 that each emit 17 milliwatt (mW) 635 nm of red laser light and the fifth diode that emits 17 mW, 405 nm of blue laser light. The MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.~The Erchonia® THL is a single diode pulsed laser that emits 4.9 mW of red 635 nm light, The THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject."
835426|NCT01276509|B5|Baseline|Total|Total of all reporting groups
835427|NCT01276509|B4|Baseline|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835429|NCT01276509|B2|Baseline|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835430|NCT01276509|B1|Baseline|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835431|NCT01276509|P4|Participant Flow|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835432|NCT01276509|P3|Participant Flow|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835433|NCT01276509|P2|Participant Flow|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835434|NCT01276509|P1|Participant Flow|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835435|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835436|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835437|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835438|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835439|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835440|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835441|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835442|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835443|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835444|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835445|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835446|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835447|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835448|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835449|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835453|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835454|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835455|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835456|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835457|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835458|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835459|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835460|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835461|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835462|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835463|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835464|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835465|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835466|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835467|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835468|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835469|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835470|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835471|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835472|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835473|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835474|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835475|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835476|NCT01276509|O4|Outcome|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835477|NCT01276509|O3|Outcome|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835478|NCT01276509|O2|Outcome|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835479|NCT01276509|O1|Outcome|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835480|NCT01276509|E4|Reported Event|Placebo|Placebo delivered SC, 3 doses separated by 4 weeks.
835481|NCT01276509|E3|Reported Event|PF-00547659 225 mg|PF-00547659 225 mg delivered SC, 3 doses separated by 4 weeks
835482|NCT01276509|E2|Reported Event|PF-00547659 75 mg|PF-00547659 75 mg delivered SC, 3 doses separated by 4 weeks
835483|NCT01276509|E1|Reported Event|PF-00547659 22.5 mg|PF-00547659 22.5 mg delivered subcutaneously (SC), 3 doses separated by 4 weeks.
835484|NCT01276457|B3|Baseline|Total|Total of all reporting groups
835528|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835485|NCT01276457|B2|Baseline|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835486|NCT01276457|B1|Baseline|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835487|NCT01276457|P2|Participant Flow|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835488|NCT01276457|P1|Participant Flow|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835489|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835544|NCT01276301|O1|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835490|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835491|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835492|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835493|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835494|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835495|NCT01276457|O2|Outcome|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835496|NCT01276457|O1|Outcome|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835529|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835618|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835497|NCT01276457|E2|Reported Event|Standard Everolimus Blood Target + Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 3-8 ng/mL. Patients also received a low dose of cyclosporine (350-500 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 400 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835498|NCT01276457|E1|Reported Event|Upper Everolimus Blood Target + Very Low Dose Cyclosporine|Patients received everolimus orally twice daily at a dose that was adjusted to achieve a drug blood trough level in the range of 8-12 ng/mL. Patients also received a very low dose of cyclosporine (150-300 ng/mL) orally twice daily that was adjusted to maintain a drug blood level of 200 ng/mL 2 hours after the morning dose. Both drugs were taken in the morning and again 12 hours later. The drugs were taken consistently either before, during, or after meals. No grapefruit or grapefruit juice was allowed throughout the study.
835499|NCT01276353|B3|Baseline|Total|Total of all reporting groups
835500|NCT01276353|B2|Baseline|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835501|NCT01276353|B1|Baseline|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835502|NCT01276353|P2|Participant Flow|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835503|NCT01276353|P1|Participant Flow|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835504|NCT01276353|O2|Outcome|E2020 10 mg|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835505|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once in the morning daily for 52 weeks in the extension phase.
835545|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835506|NCT01276353|O2|Outcome|E2020 10 mg (EM)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835507|NCT01276353|O1|Outcome|E2020 SR 23 mg|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase. E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835508|NCT01276353|E4|Reported Event|E2020 10 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835509|NCT01276353|E3|Reported Event|E2020 SR 23 mg (Extension)|E2020 SR 23 mg once daily in the morning for 52 weeks in the extension phase.
835510|NCT01276353|E2|Reported Event|E2020 10 mg (Double-blind)|E2020 10 mg 1 tablet + E2020 SR 23 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
835511|NCT01276353|E1|Reported Event|E2020 SR 23 mg (Double-blind)|E2020 SR 23 mg 1 tablet + E2020 10 mg placebo tablet once daily in the morning for 2 weeks in the double-blind phase.
835512|NCT01276327|B3|Baseline|Total|Total of all reporting groups
835513|NCT01276327|B2|Baseline|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
835514|NCT01276327|B1|Baseline|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
835515|NCT01276327|P2|Participant Flow|Sequence RTRT|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of RTRT.
835516|NCT01276327|P1|Participant Flow|Sequence TRTR|Subjects received 2 single doses of the test treatment (T; Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg) and 2 single doses of the reference treatment (R; Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet) in the sequence of TRTR.
835517|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835518|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835519|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835520|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835521|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835522|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835523|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835524|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835525|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835526|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835527|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835530|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835531|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835532|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835533|NCT01276327|O2|Outcome|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835534|NCT01276327|O1|Outcome|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835535|NCT01276327|E2|Reported Event|L5+P30 (Ref)|Individual linagliptin 5mg tablet and pioglitazone 30 mg tablet, oral administration with 240 mL water after an overnight fast
835536|NCT01276327|E1|Reported Event|FDC L5P30 (Test)|Fixed-Dose-Combination-Tablet of linagliptin 5 mg and pioglitazone 30 mg, oral administration with 240 mL water after an overnight fast
835537|NCT01276301|B1|Baseline|Entire Study Population|"An open label, randomised, two-period crossover trial. The two treatments administered were~A single dose of empagliflozin (empa) 25 mg~A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil~The two treatment periods were separated by a washout period of at least 7 days."
835538|NCT01276301|P2|Participant Flow|Empa Plus Verapamil / Empa|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg.
835539|NCT01276301|P1|Participant Flow|Empa / Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg, followed by a washout period of at least 7 days, followed by a single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835540|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835541|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835542|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835543|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835547|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835548|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835549|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835550|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835551|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835552|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835553|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835554|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835555|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835556|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835557|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835558|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835559|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835560|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835561|NCT01276301|O2|Outcome|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835562|NCT01276301|O1|Outcome|Empa|A single dose of empagliflozin (empa) 25 mg.
835563|NCT01276301|E2|Reported Event|Empa Plus Verapamil|A single dose of empagliflozin (empa) 25 mg one hour after administration of a single dose of 120mg verapamil.
835564|NCT01276301|E1|Reported Event|Empa|A single dose of empagliflozin (empa) 25 mg.
835565|NCT01276288|B1|Baseline|Overall Patients|A randomised, open-label, multiple-dose, 2- way cross-over study. All patients received 25 mg empagliflozin in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h) (days 1 to 5). Following a wash-out period of seven days, half of the patients received 25 mg hydrochlorothiazide (HCT) either on its own in a form of a film-coated tablet orally once daily (days 1 to 4) or in combination with 25 mg empagliflozin ( days 5 to 9), while the other half of the patients received 5 mg torasemide (TOR) either on its own (days 1 to 4) or in combination with the 25 mg empagliflozin ( days 5 to 9). This sequence was then reversed so that the HCT or TOR and its combination with 25 mg empagliflozin were administered first in a same manner as stated above, followed by 25 mg empagliflozin after seven days wash out period.
835566|NCT01276288|P4|Participant Flow|Empa+TOR/ Empa|Patients received 5mg torasemide (TOR) in combination with 25mg Empa. Following a wash-out period of seven days, 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
835567|NCT01276288|P3|Participant Flow|Empa/ Empa+ TOR|Patients received 25mg Empa in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 5 mg torasemide (TOR) in combination with 25mg Empa was administered.
835616|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835617|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835568|NCT01276288|P2|Participant Flow|Empa+HCT/ Empa|Patients received 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet orally once daily in combination with 25mg Empa. Following a wash-out period of seven days 25 mg Empa was administered in a form of a film-coated tablet orally once daily following an overnight fast of at least 10 hours (h).
835569|NCT01276288|P1|Participant Flow|Empa / Empa+HCT|Patients received 25mg empagliflozin (Empa) orally in a form of a film-coated tablet once daily following an overnight fast of at least 10 hours (h). Following a wash-out period of seven days, 25mg hydrochlorothiazide (HCT) in a form of a film-coated tablet was administered orally once daily in combination with 25mg Empa.
835570|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835571|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835572|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835573|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835574|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835575|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835576|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835577|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835578|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
835579|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
835580|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
835581|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
835582|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
835583|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835584|NCT01276288|O6|Outcome|TOR-M3 + Empa|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
835585|NCT01276288|O5|Outcome|TOR-M1+ Empa|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism in combination with Empa 25 mg
835586|NCT01276288|O4|Outcome|TOR Metabolite (TOR-M3)|TOR metabolite which pharmacological activity is equal to TOR after TOR undergoes extensive hepatic metabolism.
835587|NCT01276288|O3|Outcome|TOR Metabolite (TOR-M1)|TOR metabolite with one-tenth of pharmacological activity of TOR after TOR undergoes extensive hepatic metabolism.
835588|NCT01276288|O2|Outcome|TOR+ Empa|Torasemide (TOR) 5 mg and Empagliflozin (Empa) 25 mg administered once daily for 5 days
835589|NCT01276288|O1|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835590|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
835591|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835592|NCT01276288|O2|Outcome|HCT+ Empa|Hydrochlorothiazide (HCT) 25 mg followed by Empagliflozin (Empa) 25 mg administered once daily for 5 days
835593|NCT01276288|O1|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835594|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835595|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835596|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835597|NCT01276288|O3|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835598|NCT01276288|O2|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835599|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835600|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835601|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835602|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835603|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835604|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835605|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835606|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835607|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835608|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835609|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835610|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835611|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835612|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835613|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835614|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835615|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835619|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835620|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835621|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835622|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835623|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835624|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835625|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835626|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835627|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835628|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835629|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835630|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835631|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835632|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835633|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835634|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835635|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835636|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835637|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835638|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835639|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835640|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835641|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835642|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835643|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835644|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835645|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835646|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835647|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835648|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835649|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835650|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835651|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835652|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835653|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835654|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835655|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835656|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835657|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835658|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835659|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835660|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835661|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835662|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835663|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835664|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835665|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835666|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835667|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835668|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835669|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835670|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835671|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835672|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835673|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835674|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835675|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835676|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835677|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835678|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835679|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835680|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835681|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835682|NCT01276288|O5|Outcome|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835683|NCT01276288|O4|Outcome|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835684|NCT01276288|O3|Outcome|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835685|NCT01276288|O2|Outcome|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835686|NCT01276288|O1|Outcome|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835687|NCT01276288|E5|Reported Event|Empa + TOR|Empagliflozin (Empa) 25 mg + Torasemide (TOR) 5 mg administered once daily for 5 days
835688|NCT01276288|E4|Reported Event|Empa+ HCT|Empagliflozin (Empa) 25 mg + Hydrochlorothiazide (HCT) 25 mg administered once daily for 5 days
835689|NCT01276288|E3|Reported Event|Torasemide (TOR)|Torasemide (TOR) 5 mg administered once daily for 4 days
835690|NCT01276288|E2|Reported Event|Hydrochlorothiazide (HCT)|Hydrochlorothiazide (HCT) 25 mg administered once daily for 4 days
835691|NCT01276288|E1|Reported Event|Empagliflozin (Empa)|Empagliflozin (Empa) 25 mg administered once daily for 5 days
835692|NCT01276223|B4|Baseline|Total|Total of all reporting groups
835693|NCT01276223|B3|Baseline|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
835694|NCT01276223|B2|Baseline|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
835695|NCT01276223|B1|Baseline|Run-In Only|Difluprednate vehicle
835696|NCT01276223|P3|Participant Flow|Vehicle|Difluprednate vehicle (Run-In), followed by difluprednate vehicle (treatment)
835697|NCT01276223|P2|Participant Flow|Durezol|Difluprednate vehicle (Run-in), followed by difluprednate 0.05% ophthalmic emulsion (treatment)
835705|NCT01276197|B2|Baseline|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
835706|NCT01276197|B1|Baseline|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
835707|NCT01276197|P2|Participant Flow|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
835708|NCT01276197|P1|Participant Flow|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
835709|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
835710|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
835711|NCT01276197|O2|Outcome|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
835712|NCT01276197|O1|Outcome|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
835713|NCT01276197|E2|Reported Event|Arm 2: Non-Storytelling DVD|"Participant will receive an informational DVD~Non-Storytelling DVD: DVD will contain only informational component."
835714|NCT01276197|E1|Reported Event|Arm 1: Story-Telling DVD|"Participant will receive a DVD with informational and story-telling components~Story-Telling DVD: DVD will contain both informational and story-telling components."
835715|NCT01276106|B5|Baseline|Total|Total of all reporting groups
835716|NCT01276106|B4|Baseline|Placebo|Placebo: Capsule, BID
835717|NCT01276106|B3|Baseline|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
835718|NCT01276106|B2|Baseline|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
835719|NCT01276106|B1|Baseline|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
835720|NCT01276106|P4|Participant Flow|Placebo|Placebo: Capsule, BID
835721|NCT01276106|P3|Participant Flow|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
835722|NCT01276106|P2|Participant Flow|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
835723|NCT01276106|P1|Participant Flow|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
835724|NCT01276106|O4|Outcome|Placebo|Placebo: Capsule, BID
835725|NCT01276106|O3|Outcome|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
835726|NCT01276106|O2|Outcome|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
835727|NCT01276106|O1|Outcome|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
835728|NCT01276106|E4|Reported Event|Placebo|Placebo: Capsule, BID
835729|NCT01276106|E3|Reported Event|AC-201, 75mg BID|AC-201: Capsule, 75mg BID
835730|NCT01276106|E2|Reported Event|AC-201, 50mg BID|AC-201: Capsule, 50mg BID
835731|NCT01276106|E1|Reported Event|AC-201, 25mg BID|AC-201: Capsule, 25mg BID
835732|NCT01276054|B3|Baseline|Total|Total of all reporting groups
835733|NCT01276054|B2|Baseline|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
835734|NCT01276054|B1|Baseline|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
835735|NCT01276054|P2|Participant Flow|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
835736|NCT01276054|P1|Participant Flow|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
835737|NCT01276054|O2|Outcome|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
835761|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835794|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835738|NCT01276054|O1|Outcome|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
835739|NCT01276054|E2|Reported Event|SNB or ALND (+/- SNB)|"Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies"
835740|NCT01276054|E1|Reported Event|SNB Plus ARM or ALND (+/- SNB) Plus ARM|"Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.~technetium Tc 99m sulfur colloid: Given intradermally and periareolarly~methylene blue: Given subcutaneously~indocyanine green solution: Given subcutaneously~sentinel lymph node biopsy: Undergo sentinel lymph node biopsy~axillary lymph node biopsy: Undergo axillary lymph node biopsy~bioimpedance spectroscopy: Correlative studies~quality-of-life assessment: Ancillary studies~lymphedema management: Undergo axillary reverse mapping"
835741|NCT01275755|B3|Baseline|Total|Total of all reporting groups
835742|NCT01275755|B2|Baseline|ADL5945 0.25mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
835743|NCT01275755|B1|Baseline|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
835744|NCT01275755|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
835745|NCT01275755|P1|Participant Flow|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
835746|NCT01275755|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
835826|NCT01275196|E1|Reported Event|Imatinib 400 mg qd|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835747|NCT01275755|O1|Outcome|Placebo|Each participant received 1 placebo capsule orally QD during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
835748|NCT01275755|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally QD for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-milligrams (mg) ADL5945 capsule orally QD for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally QD for 1 week.
835749|NCT01275755|E1|Reported Event|Placebo|Each participant received 1 placebo capsule orally every day (QD) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
835750|NCT01275625|B1|Baseline|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835751|NCT01275625|P1|Participant Flow|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835752|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835753|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835754|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835755|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835756|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835757|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835758|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835759|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835760|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835762|NCT01275625|O1|Outcome|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835763|NCT01275625|E1|Reported Event|Maraviroc+Combivir|All participants received Maraviroc (300 milligram [mg] twice daily) in combination with Combivir (fixed dose combination of zidovudine 300 mg and lamivudine 150 mg)
835764|NCT01275586|B1|Baseline|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
835765|NCT01275586|P1|Participant Flow|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
835766|NCT01275586|O1|Outcome|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
835767|NCT01275586|E1|Reported Event|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
835768|NCT01275430|B1|Baseline|Sherlock 3CG|"Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.~Randomization did not occur due to early termination. All participants were assigned to Sherlock 3CG in phase I. Randomization would have occurred at the start of Phase II, but Phase II was not initiated due to early termination."
835769|NCT01275430|P1|Participant Flow|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System.~All participants were assigned to Sherlock 3CG in Phase I. Zero subjects started Phase II because of early termination of the study, so zero subjects were randomized. All adverse event reporting is also for Phase I (3CG) participants."
835770|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
835771|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
835772|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
835773|NCT01275430|O1|Outcome|Sherlock 3CG|Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System
835774|NCT01275430|O1|Outcome|Sherlock 3CG|Mean distance (mm) from the PICC tip to the upper Caval Atrial junction upon observation of maximum p-wave amplitude when using Sherlock 3CG.
835827|NCT01275131|B5|Baseline|Total|Total of all reporting groups
835775|NCT01275430|E1|Reported Event|Sherlock 3CG|"Subjects undergoing PICC placement had their PICCs placed in conjunction with the Sherlock 3CG Tip Confirmation System~All subjects were assigned to Sherlock 3CG in Phase I. Randomization was to have occurred in Phase II, but Phase II was not initiated due to termination of the study."
835776|NCT01275313|B3|Baseline|Total|Total of all reporting groups
835777|NCT01275313|B2|Baseline|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
835778|NCT01275313|B1|Baseline|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
835779|NCT01275313|P2|Participant Flow|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
835780|NCT01275313|P1|Participant Flow|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
835781|NCT01275313|O2|Outcome|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
835782|NCT01275313|O1|Outcome|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
835783|NCT01275313|E2|Reported Event|Cushion Only|"Receive a skin protection cushion and wheelchair training, but remain in facility-issued wheelchair~Skin Protection Cushion: Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion"
835784|NCT01275313|E1|Reported Event|Custom-Fitted Lightweight Wheelchair & Cushion|"Receive a new custom-fitted lightweight wheelchair, skin protection cushion and wheelchair skills training~Lightweight wheelchair: Seating and wheeled mobility assessment and fitting of a lightweight wheelchair"
835785|NCT01275196|B3|Baseline|Total|Total of all reporting groups
835786|NCT01275196|B2|Baseline|Nilotinib|Patients received 300 mg bid (600 mg/day)
835787|NCT01275196|B1|Baseline|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835788|NCT01275196|P2|Participant Flow|Nilotinib|Patients received 300 mg bid (600 mg/day)
835789|NCT01275196|P1|Participant Flow|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835790|NCT01275196|O3|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835791|NCT01275196|O2|Outcome|CGP74588|Major metabolite of Imatinib
835792|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835793|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835796|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835797|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835798|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835799|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835800|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835801|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835802|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835803|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835804|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835805|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835806|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835807|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835808|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835809|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835810|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835811|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835812|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835813|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835814|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835815|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835816|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835817|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835818|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835819|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835820|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835821|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835822|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835823|NCT01275196|O2|Outcome|Nilotinib|Patients received 300 mg bid (600 mg/day)
835824|NCT01275196|O1|Outcome|Imatinib|Patients received 400 mg qd (400 mg/day; may be increased to 600 mg/day).
835825|NCT01275196|E2|Reported Event|Nilotinib 300 mg Bid|Patients received 300 mg bid (600 mg/day)
835828|NCT01275131|B4|Baseline|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to a 6-hr euglycemic clamp."
835829|NCT01275131|B3|Baseline|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to a 6-hr euglycemic clamp."
835830|NCT01275131|B2|Baseline|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
835831|NCT01275131|B1|Baseline|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
835832|NCT01275131|P4|Participant Flow|Stage 3: Insulin Aspart + rHuPH20 First, Then Insulin Aspart|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp .~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp."
835907|NCT01274897|E1|Reported Event|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
835908|NCT01274715|B1|Baseline|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
835833|NCT01275131|P3|Participant Flow|Stage 3: Insulin Aspart First, Then Insulin Aspart + rHuPH20|"Participants first received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5. On Day 2 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.~After a 5- to 14-day washout period, participants received 0.12 U/kg insulin aspart administered as a CSII, for 5 days (Days 6-10; Period 2), including during a 6-hr euglycemic clamp on Days 7, 8, and 10. On Day 7 only, a 1.0 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp."
835834|NCT01275131|P2|Participant Flow|Stage 1: Insulin Aspart-rHuPH20 First, Then Insulin Aspart|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart alone as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
835835|NCT01275131|P1|Participant Flow|Stage 1: Insulin Aspart First, Then Insulin Aspart-rHuPH20|"Participants first received 0.15 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4; Period 1), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4.~After a 5- to 14-day washout period, participants received 0.15 U/kg insulin aspart and 5-micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a CSII, for 4 days (Days 5-8; Period 2), including during a 6-hr euglycemic clamp on Days 6 and 8."
835836|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835837|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835838|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835839|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6 hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835840|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835841|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835842|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835843|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835844|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835845|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835846|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835847|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
836974|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
835848|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835849|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6 hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835850|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days, including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 or Days 6 and 8.
835851|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835852|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835853|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835854|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835855|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835881|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
835882|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
835856|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835857|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835858|NCT01275131|O2|Outcome|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1 milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835859|NCT01275131|O1|Outcome|Stage 3: Insulin Aspart Alone|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1, or on Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835860|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835861|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Day 6 and 8 of Period 2.
835862|NCT01275131|O2|Outcome|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) coadministered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
835863|NCT01275131|O1|Outcome|Stage 1: Insulin Aspart Alone|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2
835864|NCT01275131|E4|Reported Event|Stage 3: Insulin Aspart + rHuPH20|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3, and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a 1-milliliter (mL) subcutaneous (SC) injection of 1.25 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835865|NCT01275131|E3|Reported Event|Stage 3: Insulin Aspart|Participants received 0.12 units per kilogram (U/kg) insulin aspart administered as a continuous subcutaneous insulin infusion (CSII), for 5 days (Days 1-5 or 6-10), including during a 6-hour (hr) euglycemic clamp on Days 2, 3 and 5 of Period 1 or Days 7, 8, and 10 of Period 2. On Day 2 or Day 7 only, a sham injection was administered 2.5 hr prior to the 6-hr euglycemic clamp.
835866|NCT01275131|E2|Reported Event|Stage 1: Insulin Aspart-rHuPH20|Participants received 0.15 units per kilogram (U/kg) insulin aspart and 5 micrograms per milliliter (μg/mL) recombinant human hyaluronidase PH20 (rHuPH20) (insulin aspart-rHuPH20) administered together as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835867|NCT01275131|E1|Reported Event|Stage 1: Insulin Aspart|Participants received 0.15 units per kilogram (U/kg) insulin aspart, administered as a continuous subcutaneous insulin infusion (CSII), for 4 days (Days 1-4 or 5-8), including during a 6-hour (hr) euglycemic clamp on Days 2 and 4 of Period 1 or Days 6 and 8 of Period 2.
835868|NCT01275092|B1|Baseline|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
835869|NCT01275092|P1|Participant Flow|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
835870|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
835871|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
835872|NCT01275092|O1|Outcome|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
835873|NCT01275092|E1|Reported Event|CorPath Robotic-assisted PCI|CorPath 200 robotic-assisted PCI
835874|NCT01275066|B4|Baseline|Total|Total of all reporting groups
835875|NCT01275066|B3|Baseline|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
835876|NCT01275066|B2|Baseline|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
835877|NCT01275066|B1|Baseline|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
835878|NCT01275066|P3|Participant Flow|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
835879|NCT01275066|P2|Participant Flow|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
835880|NCT01275066|P1|Participant Flow|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
835883|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
835884|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
835885|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
835886|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
835887|NCT01275066|O3|Outcome|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
835888|NCT01275066|O2|Outcome|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
835889|NCT01275066|O1|Outcome|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
835890|NCT01275066|E3|Reported Event|BMN110 2.0 mg/kg/Week|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
835891|NCT01275066|E2|Reported Event|BMN110 2.0 mg/kg/Qow|Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
835892|NCT01275066|E1|Reported Event|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
835893|NCT01274897|B3|Baseline|Total|Total of all reporting groups
835894|NCT01274897|B2|Baseline|Placebo|Subjects received the saline placebo.
835895|NCT01274897|B1|Baseline|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
835896|NCT01274897|P2|Participant Flow|Placebo|Subjects received the saline placebo.
835897|NCT01274897|P1|Participant Flow|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
835898|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
835899|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
835900|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
835901|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
835902|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
835903|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
835904|NCT01274897|O2|Outcome|Placebo|Subjects received the saline placebo.
835905|NCT01274897|O1|Outcome|MenACWY-CRM|Subjects received one dose of MenACWY-CRM conjugate vaccine.
835909|NCT01274715|P1|Participant Flow|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
835910|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
835911|NCT01274715|O1|Outcome|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
835912|NCT01274715|E1|Reported Event|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
835913|NCT01274611|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox wase injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
835914|NCT01274611|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual axilla within each subject to receive either Botox treatment or suction-curettage treatment.~Botox was injected into one underarm, targeting the sweat glands, to stop underarm sweating.~For Suction-Curettage, the doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating."
835915|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
835916|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
835917|NCT01274611|O2|Outcome|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
835918|NCT01274611|O1|Outcome|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
835959|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
836504|NCT01272284|B1|Baseline|Altis® SIS|Participants implanted with Altis® Single Incision Sling
835919|NCT01274611|E2|Reported Event|Suction-Curettage|The doctor inserted a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
835920|NCT01274611|E1|Reported Event|Botox|Botox was injected into the underarm, targeting the sweat glands, to stop underarm sweating.
835921|NCT01274585|B3|Baseline|Total|Total of all reporting groups
835922|NCT01274585|B2|Baseline|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
835923|NCT01274585|B1|Baseline|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
835924|NCT01274585|P2|Participant Flow|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
835925|NCT01274585|P1|Participant Flow|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
835926|NCT01274585|O2|Outcome|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
835927|NCT01274585|O1|Outcome|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
835928|NCT01274585|E2|Reported Event|Stimulation/Treatment|Posterior tibial nerve stimulation (PTNS): Stimulation using PTNS device for 30 minutes weekly for 12 weeks
835929|NCT01274585|E1|Reported Event|No Active Treatment|Posterior tibial nerve stimulation: Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
835930|NCT01274559|B3|Baseline|Total|Total of all reporting groups
835931|NCT01274559|B2|Baseline|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835932|NCT01274559|B1|Baseline|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835933|NCT01274559|P2|Participant Flow|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835934|NCT01274559|P1|Participant Flow|Extended-release Niacin/Laropiprant|Extended-release niacin (ERN)/laropiprant (LRPT) 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835935|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835936|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835937|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835938|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835939|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835940|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835941|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835942|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835943|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835944|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835945|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835946|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835947|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835948|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835949|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835950|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835951|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835952|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835953|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835954|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835955|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835956|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835957|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835958|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835960|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835961|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835962|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835963|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835964|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835965|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835966|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835967|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835968|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835969|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835970|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835971|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835972|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835973|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835974|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835975|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835976|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835977|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835978|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835979|NCT01274559|O2|Outcome|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835980|NCT01274559|O1|Outcome|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835981|NCT01274559|E2|Reported Event|Placebo|Matching 1 g Placebo (1 tablet for 4 wks) followed by 2 g placebo (2 tablets for 8 weeks)
835982|NCT01274559|E1|Reported Event|Extended-release Niacin/Laropiprant|ERN/LRPT 1 g (1 tablet for 4 wks) followed by ERN/LRPT 2 g (2 tablets for 8 wks); Each 1-g tablet contains 1 g of ER niacin and 20 mg of laropiprant.
835983|NCT01274533|B1|Baseline|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
835984|NCT01274533|P1|Participant Flow|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
835985|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
835986|NCT01274533|O1|Outcome|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
835987|NCT01274533|E1|Reported Event|Lenalidomide|"Oral lenalidomide is initiated on Day 1 of Cycle 1 and continues once daily days 1-21 of a 28 day cycle. Subjects may continue participation in the Treatment Phase of the study for 24 months unless disease progression or drug is discontinued for safety reasons.~Lenalidomide: 25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle"
835988|NCT01274429|B1|Baseline|Open Label Peanut Flour|"Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.~Peanut flour: Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose."
835989|NCT01274429|P1|Participant Flow|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
835990|NCT01274429|O1|Outcome|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
835991|NCT01274429|O1|Outcome|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
835992|NCT01274429|E1|Reported Event|Open Label Peanut Flour|Orally ingested peanut flour administered in gradually increasing doses up to a maximum maintenance dose.
835993|NCT01273896|B1|Baseline|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
835994|NCT01273896|P1|Participant Flow|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
835995|NCT01273896|O1|Outcome|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
835996|NCT01273896|E1|Reported Event|STA-9090|"This will be a monotherapy, open-label phase 2 study of STA-9090 in patients who have metastatic breast cancer.~STA-9090: All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression."
835997|NCT01273883|B1|Baseline|Entire Study Population|Includes groups randomized to receive magnesium first and placebo first.
835998|NCT01273883|P2|Participant Flow|Placebo First, Then Magnesium|Placebo daily for 25 days followed by 2 weeks of washout followed by magnesium 532 mg daily for 25 days.
835999|NCT01273883|P1|Participant Flow|Magnesium First, Then Placebo|Magnesium 532 mg daily for 25 days followed by 2 weeks of washout followed by 25 days of placebo.
836000|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
836001|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
836002|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
836003|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
836004|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
836005|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
836006|NCT01273883|O2|Outcome|Placebo|Placebo administered daily in either first intervention period or second intervention period.
836007|NCT01273883|O1|Outcome|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
836008|NCT01273883|E2|Reported Event|Placebo|Placebo administered daily in either first intervention period or second intervention period.
836009|NCT01273883|E1|Reported Event|Magnesium|Magnesium 532 mg administered daily in either first intervention period or second intervention period.
836010|NCT01273857|B3|Baseline|Total|Total of all reporting groups
836038|NCT01273805|P1|Participant Flow|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836320|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836011|NCT01273857|B2|Baseline|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836012|NCT01273857|B1|Baseline|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836013|NCT01273857|P2|Participant Flow|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836014|NCT01273857|P1|Participant Flow|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836015|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836016|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836017|NCT01273857|O2|Outcome|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836018|NCT01273857|O1|Outcome|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836019|NCT01273857|E2|Reported Event|Cell Infusion|"Subjects will receive transcoronary infusion of autologous cardiosphere-derived cells 1 month after staged shunt procedure~Autologous cardiac progenitor cell transplantation: Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
837311|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
836020|NCT01273857|E1|Reported Event|Control|"Subjects will undergo standard staged-procedures without cell infusion~staged shunt procedure: Norwood-Glenn, Glenn, or Fontan procedure will be applied"
836021|NCT01273818|B4|Baseline|Total|Total of all reporting groups
836022|NCT01273818|B3|Baseline|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
836023|NCT01273818|B2|Baseline|Cephazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
836024|NCT01273818|B1|Baseline|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
836025|NCT01273818|P3|Participant Flow|Gentamicin+ Cefazolin Sodium|Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively
836026|NCT01273818|P2|Participant Flow|Cefazolin|Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery
836027|NCT01273818|P1|Participant Flow|Gentamicin|Gentamicin arm: application of 80 mg gentamycin topically
836028|NCT01273818|O3|Outcome|Topical and iv|Total number of patients to which topical gentamicin and cephazoline (iv) was applied for prophylaxis
836029|NCT01273818|O2|Outcome|Cefazolin IV|Total number of patients to which ceephazoline (İV) was applied for prophylaxis
836030|NCT01273818|O1|Outcome|Topical Gentamicin|Total number of patients to which topical gentamicin was applied for prophylaxis
836031|NCT01273818|E3|Reported Event|Gentamicin+ Cefazolin Sodium|"Application of intravenous 1000 mg cefazolin sodium 1 hour before surgery + topical 80 mg gentamicin intraoperatively~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
836032|NCT01273818|E2|Reported Event|Cephazolin|"Application of 1000 mg cefazolin sodium intra venously 1 hour before surgery~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
836033|NCT01273818|E1|Reported Event|Gentamicin|"Gentamicin arm: application of 80 mg gentamycin topically~Gentamicins+cephazolin sodium: 80 mg topically, intra-operative,single dose~No adverse effect"
836034|NCT01273805|B3|Baseline|Total|Total of all reporting groups
836035|NCT01273805|B2|Baseline|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836036|NCT01273805|B1|Baseline|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836037|NCT01273805|P2|Participant Flow|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836065|NCT01273623|P1|Participant Flow|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
836066|NCT01273623|O1|Outcome|Study Participants|
836039|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836040|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836041|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836042|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836043|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836044|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836045|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836046|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836047|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836048|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836084|NCT01273519|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836049|NCT01273805|O2|Outcome|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836050|NCT01273805|O1|Outcome|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836051|NCT01273805|E2|Reported Event|Hydroxychloroquine 600 mg b.i.d.|Patients received 600 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836052|NCT01273805|E1|Reported Event|Hydroxychloroquine 400 mg b.i.d.|Patients received 400 mg hydroxychloroquine orally twice per day. Cycle duration was 4 weeks. Patients remained on treatment indefinitely without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
836053|NCT01273766|B4|Baseline|Total|Total of all reporting groups
836054|NCT01273766|B3|Baseline|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
836055|NCT01273766|B2|Baseline|Control Arm|blood tested on healthy patients
836056|NCT01273766|B1|Baseline|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
836057|NCT01273766|P3|Participant Flow|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
836058|NCT01273766|P2|Participant Flow|Control Arm|blood tested on healthy patients
836059|NCT01273766|P1|Participant Flow|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
836060|NCT01273766|O1|Outcome|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
836061|NCT01273766|E3|Reported Event|Correlative|treated off study with or without oral deferasirox (patient choice) but lab draws to gather lab analysis
836062|NCT01273766|E2|Reported Event|Control Arm|blood tested on healthy patients
836063|NCT01273766|E1|Reported Event|Arm I|"Patients receive oral deferasirox once daily for up to 6 months or until blood counts recover in the absence of disease progression or unacceptable toxicity.~deferasirox : Given orally~laboratory biomarker analysis : Correlative studies~enzyme-linked immunosorbent assay : Correlative studies"
836064|NCT01273623|B1|Baseline|Single Arm|subjects with calcified peripheral arterial lesions determined by intravascular ultrasound
836067|NCT01273623|O1|Outcome|Study Participants|
836071|NCT01273597|B1|Baseline|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836072|NCT01273597|P1|Participant Flow|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836073|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836074|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836075|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836076|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836077|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836078|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836079|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836080|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836081|NCT01273597|O1|Outcome|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836082|NCT01273597|E1|Reported Event|End-stage Kidney Disease With Secondary Hyperparathyroidism|Participants with chronic kidney disease (CKD) stage 5 receiving haemodialysis with a diagnosis of secondary hyperparathyroidism (SHPT)
836083|NCT01273519|B4|Baseline|Total|Total of all reporting groups
836194|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
836085|NCT01273519|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836086|NCT01273519|B1|Baseline|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836087|NCT01273519|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836088|NCT01273519|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836089|NCT01273519|P1|Participant Flow|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836090|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836091|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836092|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836093|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836094|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836095|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836096|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836097|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836098|NCT01273519|O1|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836164|NCT01273064|E4|Reported Event|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
836099|NCT01273519|O1|Outcome|PsA, AS|Participants with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836100|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836101|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836102|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836103|NCT01273519|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836104|NCT01273519|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with psoriatic arthritis (PsA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836105|NCT01273519|O1|Outcome|Rheumatoid Arthiritis (RA)|Participants with rheumatoid arthritis (RA) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836106|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836107|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836108|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836109|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836110|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836111|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836112|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836113|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836114|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836115|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836116|NCT01273519|O2|Outcome|RA, PsA, AS: Month 12|Participants at Month 12 with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836117|NCT01273519|O1|Outcome|RA, PsA, AS: Baseline|Participants at Baseline with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836118|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836119|NCT01273519|O1|Outcome|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836120|NCT01273519|E1|Reported Event|RA, PsA, AS|Participants with rheumatoid arthritis (RA), psoriatic arthritis (PsA) and ankylosing spondylitis (AS) prescribed Humira (adalimumab) in the usual manner and in accordance with the terms of the local marketing authorization with regards to dose, population and indication.
836121|NCT01273181|B5|Baseline|Total|Total of all reporting groups
836165|NCT01273064|E3|Reported Event|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
836975|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836122|NCT01273181|B4|Baseline|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836123|NCT01273181|B3|Baseline|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836124|NCT01273181|B2|Baseline|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836125|NCT01273181|B1|Baseline|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836126|NCT01273181|P4|Participant Flow|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Other cancers
836127|NCT01273181|P3|Participant Flow|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC
836128|NCT01273181|P2|Participant Flow|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836129|NCT01273181|P1|Participant Flow|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836130|NCT01273181|O4|Outcome|Anti-MAGE TCR PBL +HD IL-2, Other|"anti-MAGE A3/12 TCR PBL MTD +HD-IL-1 Other cancers~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836131|NCT01273181|O3|Outcome|Anti-MAGE TCR PBL+HD IL-2, Mel, RCC|"anti-MAGE A3/12 TCR PBL MTD + HD IL-2 Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836132|NCT01273181|O2|Outcome|Anti-MAGE TCR PBL 5x10e10 +HD IL-2|"anti-MAGE A3/12 TCR PBL 5x10e9 to 3 x 10e10 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836133|NCT01273181|O1|Outcome|Anti-MAGE TCR PBL 5x10e9 +HD IL-2|"anti-MAGE A3/12 TCR PBL 3x10e10 to 1 x 10e11 + HD IL-2~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836134|NCT01273181|O4|Outcome|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836135|NCT01273181|O3|Outcome|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836136|NCT01273181|O2|Outcome|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836137|NCT01273181|O1|Outcome|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836138|NCT01273181|E4|Reported Event|Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer|"Phase II: Anti-MAGE A3/12 TCR PBL MTD +HD IL-2, Other Cancer~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836139|NCT01273181|E3|Reported Event|Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC|"Phase II:Anti-MAGE A3/12 TCR PBL MTD+HD IL-2, Melanoma, RCC~Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836166|NCT01273064|E2|Reported Event|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
836140|NCT01273181|E2|Reported Event|Phase I:Anti-MAGE A3/12 TCR PBL 3x10e10|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836141|NCT01273181|E1|Reported Event|Phase I: Anti-MAGE A3/12 TCR PBL 5x10e9|"Cyclophosphamide : 60 mg/kg/day x 2 days intravenous (IV)~Aldesleukin : 720,000 IU/kg every 8 hours for a maximum of 15 doses~PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes :~Fludarabine : 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days."
836142|NCT01273064|B6|Baseline|Total|Total of all reporting groups
836143|NCT01273064|B5|Baseline|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
836144|NCT01273064|B4|Baseline|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
836145|NCT01273064|B3|Baseline|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
836146|NCT01273064|B2|Baseline|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
836147|NCT01273064|B1|Baseline|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
836148|NCT01273064|P5|Participant Flow|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
836149|NCT01273064|P4|Participant Flow|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
836150|NCT01273064|P3|Participant Flow|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
836151|NCT01273064|P2|Participant Flow|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
836152|NCT01273064|P1|Participant Flow|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
836195|NCT01272934|O2|Outcome|Placebo|Placebo : Topical gel-4 times daily
836153|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
836154|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
836155|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
836156|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
836157|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
836158|NCT01273064|O5|Outcome|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
836159|NCT01273064|O4|Outcome|Placebo + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets
836160|NCT01273064|O3|Outcome|CTS-1027 15 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15 mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg
836161|NCT01273064|O2|Outcome|CTS-1027 30 mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 30 mg (supplied in 30 mg tablets) taken twice daily for a total daily dose of 60 mg.
836162|NCT01273064|O1|Outcome|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
836163|NCT01273064|E5|Reported Event|Placebo + CTS-1027 15mg + Ribavirin + Pegylated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus placebo (2 tablets identical in appearance to CTS-1027) taken twice daily, for a total daily dose of 4 tablets for the first 12 weeks. Crossover to Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027 15mg (supplied in 5 mg and 10 mg tablets) taken twice daily, for a total daily dose of 30 mg starting at Week 12
836976|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
836167|NCT01273064|E1|Reported Event|CTS-1027 60 mg + Ribavirin + Peglyated Interferon|Standard of Care (ribavirin plus pegylated interferon) plus CTS-1027,60 mg (supplied in 30 mg tablets) taken twice daily, for a total daily dose of 120 mg
836168|NCT01273038|B3|Baseline|Total|Total of all reporting groups
836169|NCT01273038|B2|Baseline|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
836170|NCT01273038|B1|Baseline|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
836171|NCT01273038|P2|Participant Flow|SenSura First (Reference Filter), Then Morfeus (Test Filter)|First Intervention with SenSura (14 days) then Second Intervention with Morfeus (14 days)
836172|NCT01273038|P1|Participant Flow|Morfeus First (Test Filter), Then SenSura (Reference Filter)|First Intervention with Morfeus (14 days) then Second Intervention with SenSura (14 days)
836173|NCT01273038|O2|Outcome|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
836174|NCT01273038|O1|Outcome|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
836175|NCT01273038|E2|Reported Event|SenSura (Reference Filter)|The reference filter was the commercially available Sensura filter on the 1-piece colostomy bag.
836176|NCT01273038|E1|Reported Event|Morfeus (Test Filter)|The new filter Morfeus is intended to clean the air and prevent ballooning in a 1-piece colostomy appliance.
836177|NCT01272947|B3|Baseline|Total|Total of all reporting groups
836178|NCT01272947|B2|Baseline|Placebo|
836179|NCT01272947|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
836180|NCT01272947|P2|Participant Flow|Placebo|
836181|NCT01272947|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
836182|NCT01272947|O2|Outcome|Placebo|
836183|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
836184|NCT01272947|O2|Outcome|Placebo|
836185|NCT01272947|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
836186|NCT01272947|E2|Reported Event|Placebo|
836187|NCT01272947|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
836188|NCT01272934|B3|Baseline|Total|Total of all reporting groups
836189|NCT01272934|B2|Baseline|Placebo|Placebo : Topical gel-4 times daily
836190|NCT01272934|B1|Baseline|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
836191|NCT01272934|P2|Participant Flow|Placebo|Placebo : Topical gel-4 times daily
836192|NCT01272934|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
836193|NCT01272934|O2|Outcome|Placebo|
836196|NCT01272934|O1|Outcome|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
836197|NCT01272934|E2|Reported Event|Placebo|Placebo : Topical gel-4 times daily
836198|NCT01272934|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|"Diclofenac sodium topical gel 1%~Diclofenac Sodium : Topical gel 1%-4 times daily"
836199|NCT01272921|B3|Baseline|Total|Total of all reporting groups
836200|NCT01272921|B2|Baseline|GROUP 2|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
836201|NCT01272921|B1|Baseline|GROUP 1|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
836202|NCT01272921|P2|Participant Flow|Ropivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Ropivacaine : Varying doses to determine the duration of analgesia"
836203|NCT01272921|P1|Participant Flow|Bupivacaine|"Varying does to determine duration of analgesia following a sciatic nerve block~Bupivacaine : Varying doses to determine the duration of analgesia"
836204|NCT01272921|O2|Outcome|Ropivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
836205|NCT01272921|O1|Outcome|Bupivacaine|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
836206|NCT01272921|O2|Outcome|Below CIEL|The mean threshold current required to elicit a motor response below the common investing extraneural layer (CIEL).
836207|NCT01272921|O1|Outcome|Above CIEL|The mean threshold current required to elicit a motor response above the common investing extraneural layer (CIEL).
836208|NCT01272921|E2|Reported Event|GROUP 2|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Ropivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
836209|NCT01272921|E1|Reported Event|GROUP 1|"Varying does to determine duration(motor/sensory)of analgesia following a sciatic nerve block~Bupivacaine : 2.5ml and 5.0mL (less than 10ml) and greater than or equal to 10ml (10-30ml)"
836210|NCT01272908|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836211|NCT01272908|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg per week (mg/week) and a stable dose of folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (Disease Activity Score based on 28-Joint Count [DAS28] score of greater than or equal to [≥]2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg], given 14 days apart), at any time between Week 24 and 48.
836212|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836213|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836214|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836215|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836216|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836289|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836290|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836217|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836218|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836219|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836220|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836221|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836222|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836223|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836266|NCT01272804|P4|Participant Flow|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836267|NCT01272804|P3|Participant Flow|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836224|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836225|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836226|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836227|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836228|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836229|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836291|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836230|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836231|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836232|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836233|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836234|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836235|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836236|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836237|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836238|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836239|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836240|NCT01272908|O1|Outcome|Re-Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836241|NCT01272908|O1|Outcome|Initial Treatment Period: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836242|NCT01272908|E2|Reported Event|Re-treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion). Participants who, in the opinion of the investigator, achieved a clinically relevant response (DAS28 score of ≥2.6) to the first course of treatment received one additional course of re-treatment with rituximab (2 IV infusions of rituximab 1000 mg [and methylprednisolone 100 mg] given 14 days apart), at any time between Week 24 and 48.
836292|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836243|NCT01272908|E1|Reported Event|Initial Treatment: Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15. Participants should have been receiving a stable dose (for at least 12 weeks prior to Screening) of MTX 10-25 mg/week and a stable dose of folate (≥5 mg/week) given as either a single weekly dose or as divided daily doses (per investigator discretion).
836244|NCT01272882|B1|Baseline|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
836245|NCT01272882|P1|Participant Flow|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
836246|NCT01272882|O1|Outcome|Adults With ARDS or ALI|Adults with PaO2/FiO2 ratio less than 300. Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device
836247|NCT01272882|E1|Reported Event|Adults With ARDS or ALI|"Adults with PaO2/FiO2 ratio less than 300.~Electrical Impedance Tomography monitoring : Chest belt with 16 electrodes connected to the EIT device"
836248|NCT01272869|B3|Baseline|Total|Total of all reporting groups
836249|NCT01272869|B2|Baseline|Morfeus|The test product is the product with the proposed new filter (Morfeus)
836250|NCT01272869|B1|Baseline|Sensura|The reference product is the SenSura product which is already commercially available
836251|NCT01272869|P2|Participant Flow|Morfeus First; Then Sensura|The test product with the Morfeus filter is the test product with the proposed new filter.
836252|NCT01272869|P1|Participant Flow|Sensura First; Then Morfeus|The reference product is the SenSura product which is already commercially available
836253|NCT01272869|O2|Outcome|Morfeus|The test product is the product with the proposed new filter (Morfeus)
836254|NCT01272869|O1|Outcome|Sensura|SenSura is the reference product and the product is already commercially available
836255|NCT01272869|E2|Reported Event|Morfeus|The test product is the product with the proposed new filter (Morfeus)
836256|NCT01272869|E1|Reported Event|Sensura|The reference product is the SenSura product which is already commercially available
836257|NCT01272804|B7|Baseline|Total|Total of all reporting groups
836258|NCT01272804|B6|Baseline|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836259|NCT01272804|B5|Baseline|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836260|NCT01272804|B4|Baseline|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836261|NCT01272804|B3|Baseline|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836262|NCT01272804|B2|Baseline|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836263|NCT01272804|B1|Baseline|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836264|NCT01272804|P6|Participant Flow|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836265|NCT01272804|P5|Participant Flow|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836268|NCT01272804|P2|Participant Flow|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836269|NCT01272804|P1|Participant Flow|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836270|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836271|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836272|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836273|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836274|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836275|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836276|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836277|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836278|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836279|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836280|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836281|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836282|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836283|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836284|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836285|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836286|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836287|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836288|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836492|NCT01272583|O3|Outcome|Placebo|
836493|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836293|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836294|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836295|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836296|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836297|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836298|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836299|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836300|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836301|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836302|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836303|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836304|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836305|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836306|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836307|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836308|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836309|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836310|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836311|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836312|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836313|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836314|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836315|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836316|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836317|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836318|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836319|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836321|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836322|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836323|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836324|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836325|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836326|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836327|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836328|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836329|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836330|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836331|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836332|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836333|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836334|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836335|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836336|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836337|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836338|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836339|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836340|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836341|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836342|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836343|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836344|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836345|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836346|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836347|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836348|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836349|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836350|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836351|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836352|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836353|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836354|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836355|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836356|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836357|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836358|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836359|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836360|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836361|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836362|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836363|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836364|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836365|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836366|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836367|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836368|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836977|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836369|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836370|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836371|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836372|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836373|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836374|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836375|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836376|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836377|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836378|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836379|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836380|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836381|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836382|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836383|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836384|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836385|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836386|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836387|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836388|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836389|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836494|NCT01272583|O1|Outcome|Baseline|
836495|NCT01272583|O3|Outcome|Placebo|
836390|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836391|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836392|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836393|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836394|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836395|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836396|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836397|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836398|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836399|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836400|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836401|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836402|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836403|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836404|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836405|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836406|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836407|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836408|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836409|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836410|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836411|NCT01272804|O6|Outcome|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836412|NCT01272804|O5|Outcome|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836413|NCT01272804|O4|Outcome|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836414|NCT01272804|O3|Outcome|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836415|NCT01272804|O2|Outcome|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836416|NCT01272804|O1|Outcome|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836417|NCT01272804|E6|Reported Event|Placebo|Participants received placebo matched to PF-04937319 tablet orally once daily for 14 days.
836418|NCT01272804|E5|Reported Event|PF-04937319 300 mg|Participants received PF-04937319 300 mg (3 tablets of 100 mg) orally once daily for 14 days.
836419|NCT01272804|E4|Reported Event|PF-04937319 100 mg|Participants received PF-04937319 100 mg tablet orally once daily for 14 days.
836420|NCT01272804|E3|Reported Event|PF-04937319 50 mg|Participants received PF-04937319 50 mg (5 tablets of 10 mg) orally once daily for 14 days.
836421|NCT01272804|E2|Reported Event|PF-04937319 30 mg|Participants received PF-04937319 30 mg (3 tablets of 10 mg) orally once daily for 14 days.
836422|NCT01272804|E1|Reported Event|PF-04937319 10 mg|Participants received PF-04937319 10 milligram (mg) tablet orally once daily for 14 days.
836423|NCT01272661|B4|Baseline|Total|Total of all reporting groups
836424|NCT01272661|B3|Baseline|Enhanced Curriculum+Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836425|NCT01272661|B2|Baseline|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836426|NCT01272661|B1|Baseline|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836427|NCT01272661|P3|Participant Flow|Enhanced Curriculum +Father Support|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836428|NCT01272661|P2|Participant Flow|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836429|NCT01272661|P1|Participant Flow|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836430|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836431|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836432|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836433|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836434|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836435|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836436|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836437|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836438|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836439|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836440|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836441|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836442|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836443|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836444|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836445|NCT01272661|O3|Outcome|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836496|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836497|NCT01272583|O1|Outcome|Baseline|
836498|NCT01272583|O3|Outcome|Placebo|
836499|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836446|NCT01272661|O2|Outcome|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836447|NCT01272661|O1|Outcome|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836448|NCT01272661|E3|Reported Event|Enhanced Curriculum+Father Support Program|"Enhanced Curriculum+ mother provides father-friendly information about breastfeeding to her partner plus an invitation to an educational group for fathers~Enhanced Curriculum+Father Support Program: In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services."
836449|NCT01272661|E2|Reported Event|Enhanced Curriculum+Breastfeeding Doula|"Enhanced Curriculum + mother selects a support person to learn about breastfeeding with her and support her postpartum (breastfeeding doula)~Enhanced Curriculum+Breastfeeding Doula: In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum."
836450|NCT01272661|E1|Reported Event|Enhanced Curriculum|"New Enhanced Breastfeeding Curriculum with 11 brief modules~Enhanced Curriculum: Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers"
836451|NCT01272635|B3|Baseline|Total|Total of all reporting groups
836452|NCT01272635|B2|Baseline|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836453|NCT01272635|B1|Baseline|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836454|NCT01272635|P4|Participant Flow|Placebo/Placebo|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
836455|NCT01272635|P3|Participant Flow|Placebo/Prednisolone|"Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
836456|NCT01272635|P2|Participant Flow|Azithromycin/Placebo|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Placebo Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
836457|NCT01272635|P1|Participant Flow|Azithromycin/Prednisolone|"Active Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day~Active Prednisolone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day"
836458|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836459|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836460|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836461|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836462|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836463|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836464|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836465|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836466|NCT01272635|O2|Outcome|Placebo|Placebo Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
836467|NCT01272635|O1|Outcome|Prednisone|Active Prednisone: Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
836468|NCT01272635|O2|Outcome|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836469|NCT01272635|O1|Outcome|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836470|NCT01272635|E2|Reported Event|Placebo|Placebo Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836471|NCT01272635|E1|Reported Event|Azythromycin|Azithromycin: Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
836472|NCT01272583|B3|Baseline|Total|Total of all reporting groups
836473|NCT01272583|B2|Baseline|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
836474|NCT01272583|B1|Baseline|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
836475|NCT01272583|P2|Participant Flow|Sequence B (Placebo→Sitagliptin)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
836476|NCT01272583|P1|Participant Flow|Sequence A (Sitagliptin→Placebo)|"Cross-over, both arms reveived the same intervention in different order.~Sitagliptin : 100 mg once daily for six weeks~Placebo : placebo, once daily for six weeks"
836477|NCT01272583|O3|Outcome|Placebo|
836478|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836479|NCT01272583|O1|Outcome|Baseline|
836480|NCT01272583|O3|Outcome|Placebo|
836481|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836482|NCT01272583|O1|Outcome|Baseline|
836483|NCT01272583|O3|Outcome|Placebo|
836484|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836485|NCT01272583|O1|Outcome|Baseline|
836486|NCT01272583|O3|Outcome|Placebo|
836487|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836488|NCT01272583|O1|Outcome|Baseline|
836489|NCT01272583|O3|Outcome|Placebo|
836490|NCT01272583|O2|Outcome|Sitagliptin Treatment|
836491|NCT01272583|O1|Outcome|Baseline|
836505|NCT01272284|P1|Participant Flow|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836506|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836507|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836508|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836509|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836510|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836511|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836512|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836513|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836514|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836515|NCT01272284|O1|Outcome|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836516|NCT01272284|O1|Outcome|Altis SIS®|Participants implanted with Altis® Single Incision Sling
836517|NCT01272284|E1|Reported Event|Altis® SIS|Participants implanted with Altis® Single Incision Sling
836518|NCT01272232|B4|Baseline|Total|Total of all reporting groups
836519|NCT01272232|B3|Baseline|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836520|NCT01272232|B2|Baseline|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836521|NCT01272232|B1|Baseline|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836522|NCT01272232|P3|Participant Flow|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836670|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
836978|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
836523|NCT01272232|P2|Participant Flow|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836524|NCT01272232|P1|Participant Flow|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836525|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836526|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836527|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836528|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836590|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836529|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836530|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836531|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836532|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836533|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836534|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836561|NCT01272232|E3|Reported Event|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836535|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836536|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836537|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836538|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836539|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836540|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836541|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836645|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836542|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836543|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836544|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836545|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836546|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836547|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836548|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836549|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836550|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836551|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836552|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836553|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836554|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836646|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
836555|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836556|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836557|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836558|NCT01272232|O3|Outcome|Liraglutide Placebo|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide placebo. In the 12-week follow-up period, treatment was discontinued. In addition to placebo treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836559|NCT01272232|O2|Outcome|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836560|NCT01272232|O1|Outcome|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836562|NCT01272232|E2|Reported Event|Liraglutide 1.8 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 1.8 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 1.8 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836563|NCT01272232|E1|Reported Event|Liraglutide 3.0 mg|Exposed subjects received 56 weeks of once-daily subcutaneous (s.c.) injections with liraglutide, titrated from a starting dose of 0.6 mg in weekly increments of 0.6 mg to the target dose of 3.0 mg. In the 12-week follow-up period, treatment was discontinued. In addition to liraglutide 3.0 mg treatment, subjects were instructed to follow a hypocaloric diet and an exercise programme. Pre-trial treatment with metformin, glitazone or sulphonorylureas (SU) was continued throughout the trial (open-label) at unchanged dose, expect for SU that was reduced by 50%.
836564|NCT01272219|B5|Baseline|Total|Total of all reporting groups
836565|NCT01272219|B4|Baseline|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
836566|NCT01272219|B3|Baseline|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
836567|NCT01272219|B2|Baseline|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836568|NCT01272219|B1|Baseline|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836569|NCT01272219|P6|Participant Flow|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
837312|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
836570|NCT01272219|P5|Participant Flow|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
836571|NCT01272219|P4|Participant Flow|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836572|NCT01272219|P3|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
836573|NCT01272219|P2|Participant Flow|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
836574|NCT01272219|P1|Participant Flow|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836575|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836576|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
836577|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
836668|NCT01272141|B1|Baseline|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
836734|NCT01271803|B13|Baseline|Total|Total of all reporting groups
836578|NCT01272219|O3|Outcome|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836579|NCT01272219|O2|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide Placebo (week56-68)|Arm 1B: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to receive liraglutide placebo for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
836580|NCT01272219|O1|Outcome|Liraglutide 3.0mg (week0-56)/Liraglutide 3.0mg (week56-68)|Arm 1A: Subjects of Arm 1 (with no pre-diabetes at screening) receiving liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks were re-randomised (1:1 into liraglutide 3.0 mg or liraglutide placebo) to continue treatment with liraglutide 3.0 mg for the next 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period.
836581|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836582|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836583|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836584|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836585|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836586|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836587|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836588|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836589|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
837313|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
836591|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836592|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836593|NCT01272219|O2|Outcome|Liraglutide Placebo (160-Week)|Subjects belong to Arm 4 (with pre-diabetes at screening), received liraglutide placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836594|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (160-Week)|Subjects belong to Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 160 weeks, from randomisation.
836595|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836596|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836597|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836598|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836599|NCT01272219|O2|Outcome|Liraglutide Placebo (56-Week)|Subjects belong to Arm 2 (with no pre-diabetes at screening) and Arm 4 (with pre-diabetes at screening), received liraglutide Placebo, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836600|NCT01272219|O1|Outcome|Liraglutide 3.0 mg (56-Week)|Subjects belong to Arm 1 (with no pre-diabetes at screening) and Arm 3 (with pre-diabetes at screening), received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks, from randomisation.
836601|NCT01272219|E4|Reported Event|Liraglutide Placebo, no Pre-diabetes|Arm 2: Subjects with no pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks and then continued with liraglutide placebo for additional 12 weeks (weeks 56-68), followed by a 2 weeks off-drug follow-up period. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836669|NCT01272141|P1|Participant Flow|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
837089|NCT01270841|B5|Baseline|Total|Total of all reporting groups
836602|NCT01272219|E3|Reported Event|Liraglutide 3.0 mg, no Pre-diabetes|Arm 1 (Arm 1A + Arm 1B): Subjects with no pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for 56 weeks followed by a re-randomisation (1:1 into liraglutide 3.0 mg or liraglutide placebo) period of 12 weeks (weeks 56-68) and then an off-drug follow-up period of 2 weeks. The total duration of this treatment arm from randomisation to follow-up was 70 weeks.
836603|NCT01272219|E2|Reported Event|Liraglutide Placebo, Pre-diabetes|Arm 4: Subjects with pre-diabetes at screening received liraglutide placebo once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
836604|NCT01272219|E1|Reported Event|Liraglutide 3.0 mg, Pre-diabetes|Arm 3: Subjects with pre-diabetes at screening received liraglutide 3.0 mg, once daily (OD) subcutaneously (s.c. injection, under the skin) for initial 56 weeks then continued treatment till 160 weeks, followed by an off-drug, observational follow-up period of 12 weeks. The total duration of this treatment arm from randomisation to follow-up was 172 weeks.
836605|NCT01272193|B3|Baseline|Total|Total of all reporting groups
836606|NCT01272193|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836607|NCT01272193|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836608|NCT01272193|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836609|NCT01272193|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836610|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836611|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836612|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836613|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836614|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836615|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836616|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836617|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836618|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836619|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836620|NCT01272193|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836621|NCT01272193|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836968|NCT01271452|B1|Baseline|Vistabel®|botulinum toxin type A (Vistabel®)
836622|NCT01272193|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) according to approved labelling either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IGlar was given before breakfast or at bedtime but at the same time each day. Insulin doses were individually adjusted.
836623|NCT01272193|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously once daily (OD) either as monotherapy or in combination with no more than 2 oral antidiabetic drugs (excluding sulphonylureas/DPP-4 inhibitors/glinides). IDegAsp was given just prior to the largest meal of the day. Insulin doses were individually adjusted.
836624|NCT01272180|B5|Baseline|Total|Total of all reporting groups
836625|NCT01272180|B4|Baseline|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
836626|NCT01272180|B3|Baseline|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
836627|NCT01272180|B2|Baseline|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836628|NCT01272180|B1|Baseline|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836629|NCT01272180|P4|Participant Flow|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
836630|NCT01272180|P3|Participant Flow|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine,administered two months apart.
836631|NCT01272180|P2|Participant Flow|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836632|NCT01272180|P1|Participant Flow|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836633|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836634|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836635|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
836636|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
836637|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836638|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836639|NCT01272180|O4|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
836640|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
836641|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836642|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836643|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
836644|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836647|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836648|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836649|NCT01272180|O3|Outcome|rMenB+OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
836650|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836651|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836652|NCT01272180|O3|Outcome|rMenB +OMV|Subjects in this group received two doses of rMenB+OMV vaccine, administered two months apart.
836653|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836654|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836655|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
836656|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836657|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836658|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
836659|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836660|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836661|NCT01272180|O3|Outcome|ACWY|Subjects in this group received one dose of placebo followed by one dose of MenACWY vaccine two months later.
836662|NCT01272180|O2|Outcome|ABCWY+qOMV|Subjects in this group received two doses of ABCWY+qOMV combination vaccine, administered two months apart.
836663|NCT01272180|O1|Outcome|ABCWY+OMV|Subjects in this group received two doses of ABCWY+OMV combination vaccine, administered two months apart.
836664|NCT01272180|E4|Reported Event|ACWY|Subjects in this group received first dose of placebo followed by one dose of MenACWY vaccine administered two months apart.
836665|NCT01272180|E3|Reported Event|rMenB +OMV|Subjects in this group received two doses of rMenB + OMV vaccine, administered two months apart.
836666|NCT01272180|E2|Reported Event|ABCWY+qOMV|"Subjects in this group received two doses of rMenB (+ OMV_1/4th dose)~+and MenACWY combination vaccine, administered two months apart."
836667|NCT01272180|E1|Reported Event|ABCWY+OMV|Subjects in this group received two doses of rMenB(+ OMV_full dose) and MenACWY combination vaccine, administered two months apart.
836671|NCT01272141|O1|Outcome|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
836672|NCT01272141|E1|Reported Event|Arm A: Lapatinib Plus Everolimus|"Lapatinib and Everolimus: Lapatinib: 1250 mg by mouth daily~Everolimus: 5mg by mouth daily"
836673|NCT01272076|B1|Baseline|GA Group|Patients diagnosed with dry AMD and geographic atrophy
836674|NCT01272076|P1|Participant Flow|Dry AMD With Geographic Atrophy|Patients diagnosed with dry AMD and geographic atrophy
836675|NCT01272076|O1|Outcome|GA Group|Inter-device variability in measuring the area of Geographic Atrophy. 3 acceptable scans from 3 Cirrus HD-OCT devices (total of 9) were taken by one operator in this phase.
836676|NCT01272076|E1|Reported Event|GA Group|Patients with dry age related macular degeneration and geographic atrophy.
836677|NCT01272011|B4|Baseline|Total|Total of all reporting groups
836678|NCT01272011|B3|Baseline|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
836679|NCT01272011|B2|Baseline|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
836680|NCT01272011|B1|Baseline|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
836681|NCT01272011|P3|Participant Flow|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
836682|NCT01272011|P2|Participant Flow|Phase 2 Arm (LTF)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
836683|NCT01272011|P1|Participant Flow|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
836684|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
836685|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
836722|NCT01271907|P3|Participant Flow|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
837049|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
836686|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.~Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
836687|NCT01272011|O3|Outcome|Phase 3 Arm (Ventilatory Loading)|"Individuals were exposed to 10 days of intermittent hypoxia to determine changes in ventilatory loading.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
836688|NCT01272011|O2|Outcome|Phase 2 Arm (LTF)|"Individuals were exposed to 10 days of intermittent hypoxia to determine the effect of this intervention on ventilatory long-term facilitation, as measured by minute ventilation.~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days."
836689|NCT01272011|O1|Outcome|Phase 1 Arm (Pilot)|"Individuals were exposed to intermittent hypoxia and locomotor training to establish our interventions (set up lab, train personnel, develop study protocols/interventions, etc)~Intermittent Hypoxia: Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.~Locomotor Training: Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns."
836690|NCT01272011|E3|Reported Event|Phase 3 Arm (Ventilatory Loading)|This group of subjects was exposed to intermittent hypoxia and ventilatory loading was assessed.
836691|NCT01272011|E2|Reported Event|Phase 2 Arm (Long Term Facilitation)|This group of subjects were exposed to intermittent hypoxia and minute ventilation was recorded to determine whether ventilatory long term facilitation (LTF) was present.
836692|NCT01272011|E1|Reported Event|Phase 1 Arm (Pilot)|This group of participants were exposed to intermittent hypoxia and/or locomotor training. They were enrolled only to establish and streamline the protocol and train the laboratory personnel.
836693|NCT01271946|B3|Baseline|Total|Total of all reporting groups
836694|NCT01271946|B2|Baseline|Sheath Greater Than 6F|
836695|NCT01271946|B1|Baseline|Intent to Treat|
836696|NCT01271946|P2|Participant Flow|Sheath Greater Than 6 French (F)|Subjects in whom the procedural sheath was upsized to greater than 6F.
836697|NCT01271946|P1|Participant Flow|Intent to Treat (ITT)|The ITT cohort consists of those subjects where an attempt was made to place the Arstasis device into subject's vasculature regardless of whether or not this attempt was successful.
836698|NCT01271946|O1|Outcome|Per Protocol|Time to Ambulation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
836699|NCT01271946|O1|Outcome|Per Protocol|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
836700|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
836701|NCT01271946|O1|Outcome|Intent to Treat|Time to Bed Elevation was evaluated in subjects in whom successful access with the Arstasis device was achieved and data was available.
836969|NCT01271452|P2|Participant Flow|Bocouture®|botulinum toxin type A (Bocouture®)
836702|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
836703|NCT01271946|O1|Outcome|Intent to Treat|Time to Ambulation was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
836704|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
836705|NCT01271946|O1|Outcome|Intent to Treat|Time to Actual Discharge was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
836706|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
836707|NCT01271946|O1|Outcome|Group 1|Time to Discharge Eligibility was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
836708|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
836709|NCT01271946|O1|Outcome|Intent to Treat|Time to Hemostasis was evaluated in subjects in whom successful acess with the Arstasis device was achieved and data was available.
836710|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Minor access site-related complications observed in subjects who were upsized to sheath size greater than 6F.
836711|NCT01271946|O1|Outcome|Group 1|Minor access site-related complications observed in the intent-to-treat population.
836712|NCT01271946|O2|Outcome|Sheath Greater Than 6F|
836713|NCT01271946|O1|Outcome|Intent to Treat|
836714|NCT01271946|O2|Outcome|Sheath Greater Than 6F|Major access site-related complications observed in subjects treated with sheath size greater than 6F.
836715|NCT01271946|O1|Outcome|Intent to Treat|Major access site-related complications observed in the intent-to-treat population.
836716|NCT01271946|E2|Reported Event|Sheath Greater Than 6F|
836717|NCT01271946|E1|Reported Event|Intent to Treat|
836718|NCT01271907|B4|Baseline|Total|Total of all reporting groups
836719|NCT01271907|B3|Baseline|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
836720|NCT01271907|B2|Baseline|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836721|NCT01271907|B1|Baseline|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836940|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836723|NCT01271907|P2|Participant Flow|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836724|NCT01271907|P1|Participant Flow|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836725|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
836726|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836727|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836728|NCT01271907|O3|Outcome|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
836729|NCT01271907|O2|Outcome|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836730|NCT01271907|O1|Outcome|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836731|NCT01271907|E3|Reported Event|Cohort 2|"1 Experimental Lymphodepleting regimen +Cells~3 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells"
836732|NCT01271907|E2|Reported Event|Cohort 1|"2 Experimental Lymphodepleting regimen +Cells+Low dose IL-2~2 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL, aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836733|NCT01271907|E1|Reported Event|Cohort 0|"Drosophila generated CTL + SQ IL-2~1 fludarabine, cyclophosphamide, Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL (CTL-05), aldesleukin : Fludarabine 25 mg/m2 x 5 days Cyclophosphamide 60 mg/kg IV x2 days, Up to 1x10e10 CTL-05 cells Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection"
836735|NCT01271803|B12|Baseline|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836736|NCT01271803|B11|Baseline|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836737|NCT01271803|B10|Baseline|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836738|NCT01271803|B9|Baseline|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836739|NCT01271803|B8|Baseline|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836740|NCT01271803|B7|Baseline|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836741|NCT01271803|B6|Baseline|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836742|NCT01271803|B5|Baseline|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836743|NCT01271803|B4|Baseline|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836744|NCT01271803|B3|Baseline|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836941|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836745|NCT01271803|B2|Baseline|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836746|NCT01271803|B1|Baseline|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836747|NCT01271803|P12|Participant Flow|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836748|NCT01271803|P11|Participant Flow|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836749|NCT01271803|P10|Participant Flow|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836750|NCT01271803|P9|Participant Flow|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836751|NCT01271803|P8|Participant Flow|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836752|NCT01271803|P7|Participant Flow|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836753|NCT01271803|P6|Participant Flow|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836754|NCT01271803|P5|Participant Flow|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836755|NCT01271803|P4|Participant Flow|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-28 (28/0 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836756|NCT01271803|P3|Participant Flow|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836757|NCT01271803|P2|Participant Flow|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on Days 1-21, followed by 7 days off on Days 22-28 (21/7 dosing schedule) and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836758|NCT01271803|P1|Participant Flow|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 milligrams (mg) cobimetinib once daily (QD) on Days 1-14, followed by 14 days off on Days 15-28 (14/14 dosing schedule) and oral 720 mg vemurafenib twice daily (BID) on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836759|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836760|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836761|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836762|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836763|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
837050|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
836764|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836765|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836766|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836767|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836768|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836769|NCT01271803|O2|Outcome|BRAFi-naïve Participants|All participants who were previously untreated or previously treated but naïve to BRAF or MEK inhibitor therapy were considered as BRAFi-naïve participants. These participants were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836770|NCT01271803|O1|Outcome|Vemurafenib PD Participants|All participants who progressed on vemurafenib monotherapy immediately prior to enrollment in to this study were treated with vemurafenib in combination with cobimetinib at a particular dose combination and dosing schedule depending on the cohort in which they were enrolled until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836771|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836772|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836773|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836774|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836775|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836776|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836777|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836778|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836779|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836780|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836781|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836782|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836942|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836783|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836784|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836785|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836786|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836787|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836788|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836789|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836790|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836791|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836792|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836793|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836970|NCT01271452|P1|Participant Flow|Vistabel®|botulinum toxin type A (Vistabel®)
836794|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836795|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836796|NCT01271803|O5|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836797|NCT01271803|O4|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836798|NCT01271803|O3|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836799|NCT01271803|O2|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836800|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836801|NCT01271803|O1|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836802|NCT01271803|O7|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836803|NCT01271803|O6|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836804|NCT01271803|O5|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836805|NCT01271803|O4|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836806|NCT01271803|O3|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836807|NCT01271803|O2|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836808|NCT01271803|O1|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836809|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836810|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836811|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836812|NCT01271803|O7|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836813|NCT01271803|O6|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836814|NCT01271803|O5|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836815|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836816|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836817|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836818|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836819|NCT01271803|O2|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836820|NCT01271803|O1|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836821|NCT01271803|O8|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836822|NCT01271803|O7|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836823|NCT01271803|O6|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836824|NCT01271803|O5|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836825|NCT01271803|O4|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836826|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836827|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836828|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836829|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836830|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836831|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836832|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836833|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836834|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836835|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836836|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836837|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836838|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836839|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836840|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836841|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836842|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836843|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836844|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836845|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836846|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836847|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836848|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836849|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836850|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836851|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836852|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836853|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836854|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836855|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836856|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836857|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836858|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836859|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836860|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836861|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836862|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836863|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836864|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836865|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836866|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836867|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836868|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836869|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836870|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836871|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836872|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836873|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836874|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836875|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836876|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836877|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836878|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836879|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836880|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836881|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836882|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836883|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836884|NCT01271803|O11|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836885|NCT01271803|O10|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836886|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836887|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836888|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836889|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836890|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836891|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836892|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836893|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836894|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836895|NCT01271803|O1|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836896|NCT01271803|O10|Outcome|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836897|NCT01271803|O9|Outcome|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836898|NCT01271803|O8|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836899|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836900|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836901|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836902|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836903|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836904|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836905|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836906|NCT01271803|O1|Outcome|Dose Escalation Stage (Stage 1)|All participants who received vemurafenib and cobimetinib in any dose combination during DES, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
836907|NCT01271803|O9|Outcome|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836908|NCT01271803|O8|Outcome|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836909|NCT01271803|O7|Outcome|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836910|NCT01271803|O6|Outcome|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836911|NCT01271803|O5|Outcome|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836912|NCT01271803|O4|Outcome|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836913|NCT01271803|O3|Outcome|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836914|NCT01271803|O2|Outcome|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
837303|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
836915|NCT01271803|O1|Outcome|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836916|NCT01271803|E12|Reported Event|CES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836917|NCT01271803|E11|Reported Event|CES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836918|NCT01271803|E10|Reported Event|Cobimetinib Monotherapy (100 mg or 60 mg)|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule, or oral 100 mg cobimetinib QD on 14/14 dosing schedule of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836919|NCT01271803|E9|Reported Event|DES (Cohort 4): 80 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836920|NCT01271803|E8|Reported Event|DES (Cohort 3): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836921|NCT01271803|E7|Reported Event|DES (Cohort 2A): 100 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 100 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836922|NCT01271803|E6|Reported Event|DES (Cohort 2): 80 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 80 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836923|NCT01271803|E5|Reported Event|DES (Cohort 1D): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836924|NCT01271803|E4|Reported Event|DES (Cohort 1C): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 28/0 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836971|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836972|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
836973|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836925|NCT01271803|E3|Reported Event|DES (Cohort 1B): 60 mg Cobimetinib + 960 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 960 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836926|NCT01271803|E2|Reported Event|DES (Cohort 1A): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 21/7 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836927|NCT01271803|E1|Reported Event|DES (Cohort 1): 60 mg Cobimetinib + 720 mg Vemurafenib|Participants received oral 60 mg cobimetinib QD on 14/14 dosing schedule and oral 720 mg vemurafenib BID on Days 1-28 of every cycle (1 Cycle=28 Days), until disease progression, unacceptable toxicity, or any other discontinuation criteria were met.
836928|NCT01271712|B3|Baseline|Total|Total of all reporting groups
836929|NCT01271712|B2|Baseline|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836930|NCT01271712|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836931|NCT01271712|P2|Participant Flow|Placebo First, Then Option of Open Label Regorafenib Treatment|Double blind phase: participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks. Open Label phase: participants on placebo who switched to Regorafenib, received Regorafenib 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks.
836932|NCT01271712|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836933|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836934|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836935|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836936|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836937|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836938|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836939|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836943|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836944|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836945|NCT01271712|O2|Outcome|Placebo|Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836946|NCT01271712|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)|Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836947|NCT01271712|E4|Reported Event|Placebo, Open Label Only (Switch to Regorafenib)|Switch to Regorafenib (Open Label study phase only): Participants switched to Open label Regorafenib treatment from Placebo. Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836948|NCT01271712|E3|Reported Event|Regorafenib, Open Label Only (Regorafenib Continued)|Continue Regorafenib (Open Label study phase only): Participants continue to receive Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836949|NCT01271712|E2|Reported Event|Placebo ( Double Blind Only)|Placebo (Double Blind study phase only): Participants received matching Placebo tablets per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836950|NCT01271712|E1|Reported Event|Regorafenib (Double Blind Only)|Regorafenib (Double Blind study phase only): Participants received Regorafenib (Stivarga) 160 mg (4 x 40 mg tablets) per os once daily, 3 weeks on therapy followed by 1 week off therapy to comprise a cycle of 4 weeks
836951|NCT01271686|B1|Baseline|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost once in the evening for 4 weeks
836952|NCT01271686|P1|Participant Flow|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
836953|NCT01271686|O1|Outcome|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
836954|NCT01271686|E1|Reported Event|0.01% Bimatoprost|0.01% bimatoprost: 0.01% bimatoprost eye drop once in the evening both eyes for 4 weeks
836955|NCT01271543|B3|Baseline|Total|Total of all reporting groups
836956|NCT01271543|B2|Baseline|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836957|NCT01271543|B1|Baseline|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836958|NCT01271543|P2|Participant Flow|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836959|NCT01271543|P1|Participant Flow|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836960|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836961|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836962|NCT01271543|O2|Outcome|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836963|NCT01271543|O1|Outcome|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836964|NCT01271543|E2|Reported Event|Shikani Optical Stylet|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a Shikani optical stylet (SOS) (one size). Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836965|NCT01271543|E1|Reported Event|MacIntosh Group|Endotracheal Intubation : General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with a MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for males. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
836966|NCT01271452|B3|Baseline|Total|Total of all reporting groups
836967|NCT01271452|B2|Baseline|Bocouture®|botulinum toxin type A (Bocouture®)
836979|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836980|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
836981|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836982|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
836983|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836984|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
836985|NCT01271452|O2|Outcome|Bocouture®|botulinum toxin type A (Bocouture®)
836986|NCT01271452|O1|Outcome|Vistabel®|botulinum toxin type A (Vistabel®)
836987|NCT01271452|E2|Reported Event|Bocouture®|botulinum toxin type A (Bocouture®)
836988|NCT01271452|E1|Reported Event|Vistabel®|botulinum toxin type A (Vistabel®)
836989|NCT01271413|B3|Baseline|Total|Total of all reporting groups
836990|NCT01271413|B2|Baseline|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836991|NCT01271413|B1|Baseline|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836992|NCT01271413|P2|Participant Flow|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836993|NCT01271413|P1|Participant Flow|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836994|NCT01271413|O2|Outcome|Non-adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836995|NCT01271413|O1|Outcome|Adaptive Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836996|NCT01271413|E2|Reported Event|Cognitively Stimulating Activities: Other|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836997|NCT01271413|E1|Reported Event|Cognitively Stimulating Activities|Computerized cognitively stimulating activities: The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
836998|NCT01271244|B3|Baseline|Total|Total of all reporting groups
836999|NCT01271244|B2|Baseline|Major Depression Group|Veterans with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
837000|NCT01271244|B1|Baseline|PTSD Depression Group|Veterans with PTSD and Depression will receive Escitalopram: 10-20mg daily for 12 weeks
837001|NCT01271244|P2|Participant Flow|Major Depression Group|Veteran with Depression only will receive Escitalopram: 10-20mg daily for 12 weeks
837002|NCT01271244|P1|Participant Flow|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
837003|NCT01271244|O2|Outcome|Major Depression Group|Veterans with major depression onny receive Escitalopram: 10-20mg daily for 12 weeks
837004|NCT01271244|O1|Outcome|PTSD Depression Group|Veterans with PTSD and depession will receive Escitalopram: 10-20mg daily for 12 weeks
837005|NCT01271244|E2|Reported Event|Major Depression Group|Veterans with Major Depression only receive Escitalopram: 10-20mg daily for 12 weeks
837006|NCT01271244|E1|Reported Event|PTSD Depression Group|Veterans with PTSD and depression will receive Escitalopram: 10-20mg daily for 12 weeks
837007|NCT01271036|B3|Baseline|Total|Total of all reporting groups
837008|NCT01271036|B2|Baseline|Female|Female Participants
837009|NCT01271036|B1|Baseline|Male|Male Participants
837010|NCT01271036|P2|Participant Flow|Female|Female Participants (K-Y Brand TOUCH 2-in-1)
837011|NCT01271036|P1|Participant Flow|Males|Male Participants (K-Y Brand TOUCH 2-in-1)
837012|NCT01271036|O2|Outcome|Female|Female Participants
837013|NCT01271036|O1|Outcome|Male|Male Participants
837014|NCT01271036|O2|Outcome|Female|Female Participants
837015|NCT01271036|O1|Outcome|Male|Male Participants
837016|NCT01271036|O2|Outcome|Female|Female Participants
837017|NCT01271036|O1|Outcome|Male|Male Participants
837018|NCT01271036|O2|Outcome|Female|Female Participants
837019|NCT01271036|O1|Outcome|Male|Male Participants
837020|NCT01271036|O2|Outcome|Female|Female Participants
837021|NCT01271036|O1|Outcome|Male|Male Participants
837022|NCT01271036|E2|Reported Event|Female|Female Participants
837023|NCT01271036|E1|Reported Event|Male|Male Participants
837024|NCT01270971|B3|Baseline|Total|Total of all reporting groups
837025|NCT01270971|B2|Baseline|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
837026|NCT01270971|B1|Baseline|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
837027|NCT01270971|P2|Participant Flow|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
837028|NCT01270971|P1|Participant Flow|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
837029|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
837030|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
837031|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
837032|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
837033|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
837034|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
837035|NCT01270971|O2|Outcome|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
837036|NCT01270971|O1|Outcome|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
837037|NCT01270971|E2|Reported Event|Solution Vehicle|"Solution Vehicle~Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks"
837038|NCT01270971|E1|Reported Event|AN2690 Topical Solution, 5%|"AN2690 Topical Solution, 5%~AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks"
837039|NCT01270958|B1|Baseline|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837040|NCT01270958|P1|Participant Flow|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837041|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837042|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837043|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837044|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837045|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837046|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837047|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837048|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837051|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837052|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837053|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837054|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837055|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837056|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837057|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837058|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837059|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837060|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837061|NCT01270958|O1|Outcome|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837062|NCT01270958|E1|Reported Event|Fluticasone Furoate 110 mcg|Fluticasone furoate 110 micrograms (mcg) self-administered intranasally once daily
837063|NCT01270919|B1|Baseline|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
837064|NCT01270919|P1|Participant Flow|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
837090|NCT01270841|B4|Baseline|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837091|NCT01270841|B3|Baseline|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837092|NCT01270841|B2|Baseline|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
837093|NCT01270841|B1|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
837065|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
837066|NCT01270919|O1|Outcome|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
837067|NCT01270919|E1|Reported Event|BioDuct Meniscal Repair Device|"BioDuct Meniscal Repair Device~BioDuct Meniscal Repair Device: The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
837068|NCT01270880|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
837069|NCT01270880|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
837070|NCT01270880|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
837071|NCT01270880|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive Hsp90 inhibitor STA-9090 IV over 1 hour once weekly in weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Hsp90 inhibitor STA-9090: Given IV~laboratory biomarker analysis: Correlative studies~polymerase chain reaction: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~RNA analysis: Correlative studies~spectrophotometry: Correlative studies~reverse transcriptase-polymerase chain reaction: Correlative studies~gene expression analysis: Correlative studies"
837072|NCT01270867|B3|Baseline|Total|Total of all reporting groups
837073|NCT01270867|B2|Baseline|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
837074|NCT01270867|B1|Baseline|Merci Retriever|Patients who were randomized to the Merci Retriever
837075|NCT01270867|P2|Participant Flow|Trevo Stentriever|Patients who were randomized to the Trevo Stentriever
837076|NCT01270867|P1|Participant Flow|Merci Retriever|Patients who were randomized to the Merci Retriever
837077|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
837078|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
837079|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
837080|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
837081|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
837082|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
837083|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
837084|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
837085|NCT01270867|O2|Outcome|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
837086|NCT01270867|O1|Outcome|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
837087|NCT01270867|E2|Reported Event|Trevo Stentriever|Patients who were randomized to receive the Trevo Stentriever.
837088|NCT01270867|E1|Reported Event|Merci Retriever|Patients who were randomized to receive the Merci Retriever.
837094|NCT01270841|P4|Participant Flow|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837095|NCT01270841|P3|Participant Flow|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837096|NCT01270841|P2|Participant Flow|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
837097|NCT01270841|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
837098|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837099|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837100|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
837101|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
837102|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837103|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837104|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
837105|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
837106|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837107|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837108|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
837109|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
837110|NCT01270841|O4|Outcome|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837111|NCT01270841|O3|Outcome|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837304|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837112|NCT01270841|O2|Outcome|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
837113|NCT01270841|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
837114|NCT01270841|E4|Reported Event|Androxal 25 mg|"Androxal 25 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837115|NCT01270841|E3|Reported Event|Androxal 12.5 mg|"Androxal 12.5 mg/day~Androxal: Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months"
837116|NCT01270841|E2|Reported Event|Testim (Topical Testosterone)|"Testim (topical testosterone)~topical testosterone: testosterone gel applied 1x daily for 3 months"
837117|NCT01270841|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
837118|NCT01270828|B3|Baseline|Total|Total of all reporting groups
837119|NCT01270828|B2|Baseline|Placebo DB|Participants received matching placebo
837120|NCT01270828|B1|Baseline|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837121|NCT01270828|P3|Participant Flow|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
837122|NCT01270828|P2|Participant Flow|Placebo DB|Participants received matching placebo
837123|NCT01270828|P1|Participant Flow|Pregabalin Controlled Release (CR) DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837124|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837125|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837126|NCT01270828|O3|Outcome|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
837127|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837128|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837129|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837130|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837131|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837132|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837133|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837134|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837135|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837136|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837137|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837138|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837139|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837140|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837141|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837142|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837143|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837144|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837145|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837146|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837147|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837148|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837149|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837150|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837151|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837152|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837153|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837154|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837155|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837156|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837157|NCT01270828|O2|Outcome|Placebo DB|Participants received matching placebo
837158|NCT01270828|O1|Outcome|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837159|NCT01270828|E3|Reported Event|Pregabalin CR SB|The participants with normal CLcr (≥60 mL/min) were treated with pregabalin 165 mg/day CR; those with low CLcr (>30 - <60 mL/min) received 82.5 mg/day pregabalin CR. Subsequently, the pregabalin doses were increased based on efficacy and tolerability at each weekly visit.
837160|NCT01270828|E2|Reported Event|Placebo DB|Participants received matching placebo
837161|NCT01270828|E1|Reported Event|Pregabalin CR DB|Possible doses for participants with normal creatinine clearance (CLcr) (≥60 mL/min) during the DB fixed dose phase were pregabalin CR 165 mg/day, 330 mg/day, 495 mg/day CR or 660 mg/day CR. Doses for participants with low CLcr (>30 - <60 mL/min) were pregabalin 82.5 mg/day, 165 mg/day, 247.5 mg/day, or 330 mg/day CR.
837162|NCT01270802|B3|Baseline|Total|Total of all reporting groups
837163|NCT01270802|B2|Baseline|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
837164|NCT01270802|B1|Baseline|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
837165|NCT01270802|P2|Participant Flow|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/raltegravir : Tenofovir/emtricitabine/efavirenz (as Atripla one pill per day) will be switched to tenofovir/emtricitabine (as Truvada one pill per day) plus raltegravir (as Isentress) 400mg orally twice daily
837166|NCT01270802|P1|Participant Flow|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz (as Atripla) one pill per day
837167|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine/efavirenz will be switched to tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
837168|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
837169|NCT01270802|O2|Outcome|Switch to Tenofovir/Emtricitabine Plus Raltegravir|Tenofovir/emtricitabine plus raltegravir 400mg orally twice daily
837170|NCT01270802|O1|Outcome|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
837171|NCT01270802|E2|Reported Event|Switch to Tenofovir/Emtricitabine/Raltegravir|"Tenofovir/emtricitabine/efavirenz is switched to tenofovir/emtricitabine/raltegravir~Tenofovir/emtricitabine/raltegravir : Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine"
837172|NCT01270802|E1|Reported Event|Continued Tenofovir/Emtricitabine/Efavirenz|Tenofovir/emtricitabine/efavirenz : Continued therapy with tenofovir/emtricitabine/efavirenz
837173|NCT01270711|B9|Baseline|Total|Total of all reporting groups
837174|NCT01270711|B8|Baseline|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
837175|NCT01270711|B7|Baseline|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
837176|NCT01270711|B6|Baseline|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
837305|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837177|NCT01270711|B5|Baseline|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837178|NCT01270711|B4|Baseline|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837179|NCT01270711|B3|Baseline|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837180|NCT01270711|B2|Baseline|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837181|NCT01270711|B1|Baseline|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837182|NCT01270711|P8|Participant Flow|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
837183|NCT01270711|P7|Participant Flow|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
837184|NCT01270711|P6|Participant Flow|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
837185|NCT01270711|P5|Participant Flow|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837186|NCT01270711|P4|Participant Flow|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837187|NCT01270711|P3|Participant Flow|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837188|NCT01270711|P2|Participant Flow|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837189|NCT01270711|P1|Participant Flow|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837190|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
837191|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
837192|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
837193|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
837194|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
837195|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
837196|NCT01270711|O3|Outcome|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to SPC change (26 June 2008) and continued treatment after the recommended change to the SPC.
837197|NCT01270711|O2|Outcome|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
837198|NCT01270711|O1|Outcome|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
837199|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837200|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837201|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837202|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837203|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837204|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837205|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837206|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837207|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837208|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837209|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837347|NCT01270555|B1|Baseline|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837348|NCT01270555|P1|Participant Flow|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837210|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837211|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837212|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837213|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837214|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837215|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837216|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837306|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837307|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837217|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837218|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837219|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837220|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837221|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837222|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837223|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837224|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837225|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837226|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837227|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837228|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837229|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837230|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837231|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837232|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837233|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837234|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837235|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837236|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837237|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837238|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837239|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837240|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837241|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837242|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837243|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837244|NCT01270711|O3|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837245|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837246|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837349|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837350|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837247|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837248|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837249|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837250|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837251|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837252|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837253|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837254|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837255|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837256|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837257|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837258|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837259|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837260|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837261|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837262|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837263|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837264|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837351|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837265|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837266|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837267|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837268|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837269|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837270|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837271|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837272|NCT01270711|O5|Outcome|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837308|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837309|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837310|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837273|NCT01270711|O4|Outcome|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837274|NCT01270711|O3|Outcome|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837275|NCT01270711|O2|Outcome|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837276|NCT01270711|O1|Outcome|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837277|NCT01270711|E8|Reported Event|Cabergoline in Cross-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to date of the recommended SPC change, 26 June 2008 (Week 130) and continued treatment after the recommended change to the SPC.
837278|NCT01270711|E7|Reported Event|Cabergoline in Post- SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease after the date of the recommended SPC change, 26 June 2008 (Week 130).
837279|NCT01270711|E6|Reported Event|Cabergoline in Pre-SPC Change Period [Part 2]|Participants who started cabergoline treatment for Parkinson’s disease prior to the date of the recommended Summary of Product Characteristics (SPC) change, 26 June 2008 (Week 130) and stopped treatment before the recommended change to the SPC.
837280|NCT01270711|E5|Reported Event|THIN [Part 1]|Participants who were registered in The Health Improvement Network (THIN) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. THIN is a database of primary care medical records recorded by the GPs using the vision general practice computer system in the United Kingdom.
837281|NCT01270711|E4|Reported Event|PHARMO [Part 1]|Participants who were registered in PHARMO database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. PHARMO system linked participants’ medical histories to prescription drugs (pharmacy database), diagnostic/therapeutic data from hospitals, clinical lab and pathological findings, GP records and drug histories in hospital throughout the Netherlands.
837282|NCT01270711|E3|Reported Event|IPCI [Part 1]|Participants who were registered in Integrated Primary Care Information (IPCI) database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. IPCI is a longitudinal observational database that contains data from computer-based participant records of a selected group of GPs throughout the Netherlands.
837352|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837353|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837283|NCT01270711|E2|Reported Event|HSD [Part 1]|Participants who were registered in Health Search Database (HSD) and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. HSD is a longitudinal observational database that contained data from computer-based participant records of a selected group of general practitioners (GPs) located throughout Italy.
837284|NCT01270711|E1|Reported Event|Aarhus [Part 1]|Participants who were registered in Aarhus database and treated with cabergoline during the study period 01 January 2006 through 01 July 2012 (339 weeks) were included. The Aarhus hospital databases comprise clinical and prescription data on the population of Central and the North Denmark Region.
837285|NCT01270620|B3|Baseline|Total|Total of all reporting groups
837286|NCT01270620|B2|Baseline|Propofol|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
837287|NCT01270620|B1|Baseline|Desflurane|"Patients received propofol or desflurane as general anesthetic for total knee replacement.~Inclusion criteria: Age > 65 years old; BMI > 30 kg/m2; undergoing primary total knee replacement surgery; and ASA classification II-III"
837288|NCT01270620|P2|Participant Flow|Propofol Group|"Patients will receive propofol as general anesthetic Propofol is an intravenous agent which will be provided continuously via IV in doses varying from 100 to 200 mcg/kg/min according to BIS monitoring.~Propofol: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
837289|NCT01270620|P1|Participant Flow|Desflurane Group|"Patients will receive desflurane as general anesthetic. Desflurane is inhaled agent which will be provided continuously via ETT in concentrations varying from 4-6% according to BIS monitoring.~Desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
837290|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837291|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837292|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837293|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837294|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837295|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837296|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837297|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837298|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837299|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837300|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837301|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as a general anesthetic
837302|NCT01270620|O2|Outcome|Propofol|Patients received propofol as a general anesthetic
837314|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837315|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837316|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837317|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837318|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837319|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837320|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837321|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837322|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837323|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837324|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837325|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837326|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837327|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837328|NCT01270620|O2|Outcome|Propofol|Patient received propofol as a general anesthesia
837329|NCT01270620|O1|Outcome|Desflurane|Patient received desflurane as a general anesthesia
837330|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
837331|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
837332|NCT01270620|O2|Outcome|Propofol|Patients received propofol as general anesthetic
837333|NCT01270620|O1|Outcome|Desflurane|Patients received desflurane as general anesthetic
837334|NCT01270620|O2|Outcome|Propofol|"Patients received propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
837335|NCT01270620|O1|Outcome|Desflurane|"Patients received desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
837336|NCT01270620|E2|Reported Event|Propofol|"Patients will receive propofol as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
837337|NCT01270620|E1|Reported Event|Desflurane|"Patients will receive desflurane as general anesthetic~propofol or desflurane: comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia"
837338|NCT01270581|B3|Baseline|Total|Total of all reporting groups
837354|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837355|NCT01270555|O1|Outcome|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837356|NCT01270555|E1|Reported Event|Bupropion|Once daily treatment with Bupropion with intention to treat ADHD and SUD.
837339|NCT01270581|B2|Baseline|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
837340|NCT01270581|B1|Baseline|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
837341|NCT01270581|P2|Participant Flow|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
837342|NCT01270581|P1|Participant Flow|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
837363|NCT01270529|P1|Participant Flow|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837400|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837343|NCT01270581|O2|Outcome|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
837344|NCT01270581|O1|Outcome|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
837345|NCT01270581|E2|Reported Event|Control Group- Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
837346|NCT01270581|E1|Reported Event|High Flow Nasal Cannula|Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7. Newborns randomized to HFNC will be started on a flow rate of 4L/min and supplemental oxygen will be provided to maintain oxygen saturations between 88-93% (experimental group). Once initiated, the gas flow rate will be titrated as needed by the attending neonatologist to ameliorate signs of respiratory distress to a maximum flow rate of 6L/min. The nasal cannula size (0.2 cm or 0.3 mm outer diameter) will determined by the caliber of the subject's nares).
837358|NCT01270529|B3|Baseline|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837359|NCT01270529|B2|Baseline|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837360|NCT01270529|B1|Baseline|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837361|NCT01270529|P3|Participant Flow|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837362|NCT01270529|P2|Participant Flow|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837401|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837364|NCT01270529|O3|Outcome|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837365|NCT01270529|O2|Outcome|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837366|NCT01270529|O1|Outcome|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837367|NCT01270529|E3|Reported Event|Kidney Transplant Recipients|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837368|NCT01270529|E2|Reported Event|ESRD on Dialysis|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837369|NCT01270529|E1|Reported Event|CKD Stages 1-4|Increasing Physical activity: The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
837370|NCT01270503|B1|Baseline|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
837371|NCT01270503|P1|Participant Flow|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
837372|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants received a single dose of Menactra vaccine
837373|NCT01270503|O1|Outcome|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
837374|NCT01270503|E1|Reported Event|Menactra® Vaccine Group|Participants who received a single dose of Menactra vaccine
837375|NCT01270464|B4|Baseline|Total|Total of all reporting groups
837376|NCT01270464|B3|Baseline|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837377|NCT01270464|B2|Baseline|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837378|NCT01270464|B1|Baseline|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837379|NCT01270464|P3|Participant Flow|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837380|NCT01270464|P2|Participant Flow|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837381|NCT01270464|P1|Participant Flow|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837382|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837383|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837384|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837385|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837386|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837387|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837388|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837389|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837390|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837391|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837392|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837393|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837394|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837395|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837396|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837397|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837398|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837399|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837402|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837403|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837404|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837405|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837406|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837407|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837408|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837409|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837410|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837411|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837412|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837413|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837414|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837415|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837416|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837417|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837418|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837419|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837420|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837421|NCT01270464|O3|Outcome|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837422|NCT01270464|O2|Outcome|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837423|NCT01270464|O1|Outcome|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837424|NCT01270464|E3|Reported Event|Reslizumab - 3.0 mg/kg|3.0 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837425|NCT01270464|E2|Reported Event|Reslizumab - 0.3 mg/kg|0.3 mg/kg, administered intravenously (iv) once every 4 weeks, for a total of 4 doses
837426|NCT01270464|E1|Reported Event|Placebo|Placebo administered intravenously (iv) once every 4 weeks, for a total of 4 doses.
837427|NCT01270256|B3|Baseline|Total|Total of all reporting groups
837428|NCT01270256|B2|Baseline|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
837429|NCT01270256|B1|Baseline|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
837430|NCT01270256|P2|Participant Flow|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
837431|NCT01270256|P1|Participant Flow|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
837432|NCT01270256|O2|Outcome|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
837433|NCT01270256|O1|Outcome|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
837434|NCT01270256|E2|Reported Event|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
837435|NCT01270256|E1|Reported Event|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
837436|NCT01270139|B4|Baseline|Total|Total of all reporting groups
837437|NCT01270139|B3|Baseline|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837438|NCT01270139|B2|Baseline|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837490|NCT01270126|E1|Reported Event|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
837439|NCT01270139|B1|Baseline|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837440|NCT01270139|P3|Participant Flow|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837441|NCT01270139|P2|Participant Flow|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogeneic stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837442|NCT01270139|P1|Participant Flow|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogeneic stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837443|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837444|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837445|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837491|NCT01269918|B3|Baseline|Total|Total of all reporting groups
837492|NCT01269918|B2|Baseline|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837493|NCT01269918|B1|Baseline|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837594|NCT01268891|B2|Baseline|Azilect®|1 mg daily; tablet; orally; 18 weeks
837446|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837447|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837448|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837449|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837450|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837451|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837452|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837467|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837453|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837454|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837455|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837456|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837464|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837457|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837458|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837459|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837484|NCT01270126|B1|Baseline|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
837485|NCT01270126|P2|Participant Flow|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
837460|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837461|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837462|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837463|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837465|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837466|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837486|NCT01270126|P1|Participant Flow|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
837487|NCT01270126|O2|Outcome|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
837468|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837469|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837470|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837471|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837507|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837508|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837509|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837472|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837473|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837474|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837488|NCT01270126|O1|Outcome|rtACS (Verum Condition)|"Repetitive transorbital alternating current stimulation (rtACS)~Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation."
837489|NCT01270126|E2|Reported Event|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
837475|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837476|NCT01270139|O3|Outcome|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837477|NCT01270139|O2|Outcome|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837478|NCT01270139|O1|Outcome|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837479|NCT01270139|E3|Reported Event|Stenting Control|In case of control group, XIENCE V stent was implanted to 60 patients. Patients with a single de novo native coronary stenosis of less than 12 mm lesion length, more than 50% stenosis and reference diameter of 3.0 mm as assessed by online QCA were stented by a single stent of 3.0 x 18 mm. The procedure of implantation had to be performed according to common interventional practices including the administration of intracoronary nitroglycerine 0.2 mg of glycerol trinitrate or isosorbide dinitrate and intra-arterial heparin (50-100 U/kg body weight). Predilation with a conventional balloon catheter was recommended before DES deployment according to the manufacturer's recommendation. The protocol recommended the study stent should cover 2 mm of non-diseased tissue on either side of the target lesion. Postdilatation was allowed with a balloon that was shorter than was the study device.
837480|NCT01270139|E2|Reported Event|Ferro Group|60 patients in Ferro group were managed with intracoronary infusion of allogenous stem cells or CD68 targeted micro-bubbles pre-cultivated in the medium with iron-bearing NP. Cells and/ or micro-bubbles were infused with QCA- and IVUS-guidance to the target coronary artery via micro-catheter on the day of admission at the Acute Care Unit. The destruction of CD68 targeted micro-bubbles was obtained by using a Sonos 5500 machine with an S3 transducer operating in ultraharmonic mode (transmit, 1.3MHz/ receive, 3.6 MHz) with a mechanical index of 1.5 and a depth of 4 cm. The AXIOM Artis dBC (Siemens) magnetic navigation system was used for precise delivery of NP to the atheroma through two permanent computer-controlled external magnets generating a navigational magnetic field of 0.08 Tesla in any direction with opportunity to produce a spot at the area of target artery and lesion. NP were detonated with NIR laser at the end of the procedure under the protection of anti-platelet therapy.
837481|NCT01270139|E1|Reported Event|Nano Group|60 patients in Nano group were treated with bioengineered patch that was grown with allogenous stem cells pre-cultivated in the medium with NP. After the admission, patients were examined with QCA, and allocated to the trial. The implantation of the patch onto the artery was undergone by the minimally invasive cardiac surgery (MICS CABG) with fixation of the graft to the epicardial myocardium. MICS CABG implies a beating-heart multi-vessel heart surgery performed through several small incisions under direct vision through an anterolateral mini-thoracotomy in the 4th-6th intercostal spaces. The approach considered as an alternative to PCI allowing quick recover without major complications. The patients can expect high quality of life resuming all everyday activities within a few weeks of their operation. NP were activated with NIR laser at 7 days after the intervention. Patients were treated with bolus of bivalirudin on the day of NP detonation.
837482|NCT01270126|B3|Baseline|Total|Total of all reporting groups
837483|NCT01270126|B2|Baseline|Sham Stimulation (Placebo Condition)|A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
837494|NCT01269918|P2|Participant Flow|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837495|NCT01269918|P1|Participant Flow|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837496|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837497|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837498|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837499|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837500|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837501|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837502|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837503|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837504|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837505|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837506|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837580|NCT01268943|B1|Baseline|1000mg|capecitabine 500mg/m2 twice daily. 6 patients enrolled
837510|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837511|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837512|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837513|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837514|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837515|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837516|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837517|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837518|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837519|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837520|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837521|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837522|NCT01269918|O2|Outcome|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837523|NCT01269918|O1|Outcome|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837524|NCT01269918|E2|Reported Event|Dexmedetomidine|"a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.~Dexmedetomidine: a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour."
837525|NCT01269918|E1|Reported Event|Remifentanil|"Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS~Remifentanil: Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS"
837526|NCT01269801|B3|Baseline|Total|Total of all reporting groups
837527|NCT01269801|B2|Baseline|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
837528|NCT01269801|B1|Baseline|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
837529|NCT01269801|P2|Participant Flow|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
837530|NCT01269801|P1|Participant Flow|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
837531|NCT01269801|O2|Outcome|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
837532|NCT01269801|O1|Outcome|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
837815|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily. Unadjusted change from baseline.
837533|NCT01269801|E2|Reported Event|JUVÉDERM|"JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel~Juvederm group will initially receive JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions at Day 1.~At Week 4, patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
837534|NCT01269801|E1|Reported Event|Botox Cosmetic|"Botox group will initially receive BOTOX® Cosmetic injections to the affected facial regions at Day 1.~At Week 4, patients who initially received BOTOX® Cosmetic treatment will be crossed over to receive JUVÉDERM® Ultra XC and JUVÉDERM® Ultra Plus XC Injectable Gel treatment."
837535|NCT01269710|B1|Baseline|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837536|NCT01269710|P1|Participant Flow|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837537|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837593|NCT01268891|B3|Baseline|Total|Total of all reporting groups
837538|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837539|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837540|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837541|NCT01269710|O1|Outcome|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837542|NCT01269710|E1|Reported Event|Observed Treatment Group|"Participants in the observed treatment group will include up to 200 individuals between the ages of 3 and 19 who have a clinical diagnosis of psychotic spectrum, mood spectrum, or autism spectrum disorder and are considered for treatment with a second generation antipsychotic (SGA) by their treating clinician.~Participants will be evaluated for biological and genetic risk factors for nutritional and metabolic adverse effects associated with SGAs during 4 visits over 12 weeks. Participants will also be evaluated at Month 6, 9, and 12.~All participants were prescribed risperidone (Risperdal) for the duration of study participation and doses ranged from 0.25 mg to 6 mg daily for 52 weeks."
837543|NCT01269346|B1|Baseline|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837581|NCT01268943|P4|Participant Flow|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837816|NCT01267227|E4|Reported Event|Placebo|Matching placebo twice daily
837544|NCT01269346|P1|Participant Flow|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as an IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837545|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837546|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837547|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837548|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837549|NCT01269346|O1|Outcome|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837550|NCT01269346|E1|Reported Event|Eribulin Mesylate in Combination With Trastuzumab|"Eribulin Mesylate: Eribulin mesylate 1.4 mg/m^2 was administered as an IV infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.~Trastuzumab 8 mg/kg was administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg was administered as an IV infusion over a 30-minute period on Day 1 of each subsequent 21-day cycle."
837551|NCT01269125|B4|Baseline|Total|Total of all reporting groups
837552|NCT01269125|B3|Baseline|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837553|NCT01269125|B2|Baseline|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837554|NCT01269125|B1|Baseline|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837555|NCT01269125|P3|Participant Flow|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837556|NCT01269125|P2|Participant Flow|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837557|NCT01269125|P1|Participant Flow|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837558|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837559|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837560|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837561|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837562|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837563|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837564|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837565|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837566|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837567|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837568|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837569|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837570|NCT01269125|O3|Outcome|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837571|NCT01269125|O2|Outcome|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837572|NCT01269125|O1|Outcome|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837573|NCT01269125|E3|Reported Event|Tubal Infertility, IVF|Women with tubal infertility underwent an IVF attempt.
837574|NCT01269125|E2|Reported Event|Endometriosis, IVF|Women with mild endometriosis who underwent an IVF attempt without prior administration of GnRH-a.
837575|NCT01269125|E1|Reported Event|Endometriosis, GnRH-a Treatment, IVF|Women with mild endometriosis who received GnRH-a treatment prior to an IVF attempt.
837576|NCT01268943|B5|Baseline|Total|Total of all reporting groups
837577|NCT01268943|B4|Baseline|1500mg|capecitabine 750mg/m2 twice daily. 6 patients enrolled
837578|NCT01268943|B3|Baseline|1400mg|capecitabine 700mg/m2 twice daily. 3 patients enrolled
837579|NCT01268943|B2|Baseline|1200mg|capecitabine 600mg/m2 twice daily. 3 patients enrolled
837582|NCT01268943|P3|Participant Flow|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837583|NCT01268943|P2|Participant Flow|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837584|NCT01268943|P1|Participant Flow|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837585|NCT01268943|O4|Outcome|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837586|NCT01268943|O3|Outcome|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837587|NCT01268943|O2|Outcome|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837588|NCT01268943|O1|Outcome|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837589|NCT01268943|E4|Reported Event|1500mg|"capecitabine 1500mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837590|NCT01268943|E3|Reported Event|1400mg|"capecitabine 1400mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837591|NCT01268943|E2|Reported Event|1200mg|"capecitabine 1200mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837592|NCT01268943|E1|Reported Event|1000mg|"capecitabine 1000mg/m2/d d1-14, d22-35 combined with concurrent radiotherapy will be given to enrolled patients.~Capecitabine: oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation."
837595|NCT01268891|B1|Baseline|Placebo|Once daily; tablet; orally; 18 weeks
837596|NCT01268891|P2|Participant Flow|Azilect®|1 mg daily; tablet; orally; 18 weeks
837597|NCT01268891|P1|Participant Flow|Placebo|Once daily; tablet; orally; 18 weeks
837598|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
837599|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
837600|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
837601|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
837602|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
837603|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
837604|NCT01268891|O2|Outcome|Azilect®|1 mg daily; tablet; orally; 18 weeks
837605|NCT01268891|O1|Outcome|Placebo|Once daily; tablet; orally; 18 weeks
837606|NCT01268891|E2|Reported Event|Azilect®|
837607|NCT01268891|E1|Reported Event|Placebo|
837608|NCT01268683|B1|Baseline|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
837609|NCT01268683|P1|Participant Flow|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion; total of 3mg/day
837610|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
837611|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
837612|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection): Bolus plus 72 hour IV infusion
837613|NCT01268683|O1|Outcome|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
837614|NCT01268683|E1|Reported Event|RP-1127 (Glyburide for Injection)|RP-1127 (Glyburide for injection) : Bolus plus 72 hour IV infusion
837615|NCT01268566|B1|Baseline|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837616|NCT01268566|P1|Participant Flow|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837617|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837618|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837619|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837620|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837674|NCT01268150|B1|Baseline|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837621|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837622|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837623|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837624|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837625|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837626|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837627|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837628|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837629|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837630|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837698|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
837631|NCT01268566|O1|Outcome|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837632|NCT01268566|E1|Reported Event|MEDI-575, 25 mg/kg|MEDI-575 administered as an intravenous infusion at 25 mg/kg over a period of 60-minute on Day 1 of each 21-day cycle until disease progression, initiation of alternative anticancer therapy, unacceptable toxicity, or other reasons for participant withdrawal.
837633|NCT01268501|B1|Baseline|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
837634|NCT01268501|P1|Participant Flow|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
837635|NCT01268501|O1|Outcome|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
837636|NCT01268501|E1|Reported Event|Lotrafilcon B Multifocal|Lotrafilcon B multifocal contact lenses worn bilaterally for 3 weeks on a daily wear basis
837637|NCT01268488|B1|Baseline|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
837638|NCT01268488|P1|Participant Flow|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
837639|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
837640|NCT01268488|O1|Outcome|Intended Users of the System|Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
837641|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
837642|NCT01268488|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.
837675|NCT01268150|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837813|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily. Unadjusted change from baseline.
837643|NCT01268488|E1|Reported Event|Intended Users of the System|"Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor.~Ninja 2 Investigational Blood Glucose Meter : Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff."
837644|NCT01268306|B1|Baseline|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
837645|NCT01268306|P1|Participant Flow|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
837646|NCT01268306|O1|Outcome|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
837647|NCT01268306|E1|Reported Event|Bausch & Lomb (B+L) Biotrue MPS With B+L PureVision Lenses|Use of B+L Biotrue multipurpose solution (MPS) with PureVision contact lenses : Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
837648|NCT01268293|B1|Baseline|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
837649|NCT01268293|P1|Participant Flow|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
837650|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
837651|NCT01268293|O1|Outcome|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
837652|NCT01268293|E1|Reported Event|E7080|E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable.
837653|NCT01268267|B1|Baseline|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
837654|NCT01268267|P1|Participant Flow|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
837655|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
837656|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
837657|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
837658|NCT01268267|O1|Outcome|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
837659|NCT01268267|E1|Reported Event|Intended Users of the System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
837660|NCT01268189|B1|Baseline|Burn Wound Patients|Burn wound patients with oxygen diffusing dressing placed on 1 donor skin graft site and standard of care (Xeroform) dressing placed on a 2nd donor skin graft
837661|NCT01268189|P1|Participant Flow|Burn Wound Patients|Burn wound patients with experimental (oxyband) and control (Xeroform) dressings placed on 2 separate skin graft donor sites
837662|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
837663|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
837664|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
837665|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
837666|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
837667|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
837668|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
837669|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
837670|NCT01268189|O2|Outcome|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
837671|NCT01268189|O1|Outcome|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
837672|NCT01268189|E2|Reported Event|Control Dressing|"Xeroform (current standard of care) dressing applied to wound~Control dressing: Xeroform control dressing applied to control wound"
837673|NCT01268189|E1|Reported Event|Study Dressing|"Oxygen diffusing dressing applied to wound~Oxygen diffusing dressing: Oxygen diffusing dressing applied to study wound"
837814|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily. Unadjusted change from baseline.
837676|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837677|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837678|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837679|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837680|NCT01268150|O1|Outcome|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837681|NCT01268150|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate at 1.4 mg/m^2 was administered as an intravenous (IV) infusion over 2 to 5 minutes on Days 1 and 8 of each 3-week cycle.
837682|NCT01268111|B3|Baseline|Total|Total of all reporting groups
837683|NCT01268111|B2|Baseline|Placebo|Matching placebo q weekly for 8 weeks
837684|NCT01268111|B1|Baseline|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
837685|NCT01268111|P2|Participant Flow|Placebo|Matching placebo q weekly for 8 weeks
837686|NCT01268111|P1|Participant Flow|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
837687|NCT01268111|O2|Outcome|Placebo|Matching placebo q weekly for 8 weeks
837688|NCT01268111|O1|Outcome|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
837689|NCT01268111|E2|Reported Event|Placebo|Matching placebo q weekly for 8 weeks
837690|NCT01268111|E1|Reported Event|Vitamin D|ERgocalcifoerol 50,000 units q weekly for 8 weeks
837691|NCT01268098|B3|Baseline|Total|Total of all reporting groups
837692|NCT01268098|B2|Baseline|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
837693|NCT01268098|B1|Baseline|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
837694|NCT01268098|P2|Participant Flow|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily.
837695|NCT01268098|P1|Participant Flow|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily.
837696|NCT01268098|O2|Outcome|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
837697|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
837699|NCT01268098|O1|Outcome|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
837700|NCT01268098|E2|Reported Event|NPSP558 - 50 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 50 mcg subcutaneously daily
837701|NCT01268098|E1|Reported Event|NPSP558 - 25 µg Dose|NPSP558: Recombinant Human Parathyroid hormone (rhPTH[1-84]) 25 mcg subcutaneously daily
837702|NCT01267994|B1|Baseline|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
837703|NCT01267994|P1|Participant Flow|Open Label Trial|Open label, single arm trial of anakinra for corticosteroid-resistant Autoimmune Inner Ear Disease
837704|NCT01267994|O1|Outcome|Single Arm|Patients with Autoimmune Inner Ear Disease that had <5dB hearing improvement in response to corticosteorids following 28 days of treatment
837705|NCT01267994|E1|Reported Event|Single Arm|Anakinra administered for 84 consecutive days
837706|NCT01267929|B3|Baseline|Total|Total of all reporting groups
837707|NCT01267929|B2|Baseline|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
837708|NCT01267929|B1|Baseline|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
837709|NCT01267929|P2|Participant Flow|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
837710|NCT01267929|P1|Participant Flow|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
837711|NCT01267929|O2|Outcome|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
837712|NCT01267929|O1|Outcome|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
837713|NCT01267929|E2|Reported Event|The Conventional Physical Therapy|The children receive manual physical therapy regularly at the hospital once a week for first two months and twice a month for last four months. The conventional physical therapy technique in this study derive from the manual technique including the Bobath concept, stretching exercise and functional training for 30-45 minutes at a time.
837714|NCT01267929|E1|Reported Event|The Mirror Neurons Stimulation Based VCD Program|The children receive the mirror neurons stimulation based Video Compact Disc (VCD) program and practice at home three times a day for six months. The mirror neurons stimulation based VCD program that contained four volumes. The first volume includes activities activities for improving balance in sitting position. The second volume includes activities of sitting to standing. The third volume includes activities for improving balance in standing position. The last one includes activities of sideway walking. The running time of each volume is 30 minutes. The children had been practicing for two weeks per volume. Their parents were trained for practicing their children by VCD program at home and were asked to complete daily record of children's activities. The children were scheduled to meet a pediatric physical therapist once a week to monitor possible side effects.
837715|NCT01267422|B1|Baseline|All Study Participants|Age,Gender,Ethnicity,Race,Region of Enrollment
837716|NCT01267422|P2|Participant Flow|Participants Receiving Treatment in Right Eye|4 participants receiving treatment in right eye
837717|NCT01267422|P1|Participant Flow|Participants Receiving Treatment in Left Eye|5 participants receiving treatment in left eye
837718|NCT01267422|O2|Outcome|Mean VFI After Treatment|Mean VFI after treatment of injected eyes;Mean VFI after treatment of uninjected eyes
837719|NCT01267422|O1|Outcome|Mean VFI Before Treatment|Mean VFI before treatment of injected eyes;Mean VFI before treatment of uninjected eyes
837720|NCT01267422|O2|Outcome|Mean MD After Treatment|Mean MD after treatment of injected eyes;Mean MD after treatment of uninjected eyes
837721|NCT01267422|O1|Outcome|Mean MD Before Treatment|Mean MD before treatment of injected eyes;Mean MD before treatment of uninjected eyes
837722|NCT01267422|O2|Outcome|Average RNFL Thickness After Treatment|Average RNFL thickness after treatment of injected eyes;Average RNFL thickness after treatment of uninjected eyes
837723|NCT01267422|O1|Outcome|Average RNFL Thickness Before Treatment|Average RNFL thickness before treatment of injected eyes;Average RNFL thickness before treatment of uninjected eyes
837724|NCT01267422|O2|Outcome|The Mean of Neutralizing Antibody Assay After Treatment|The mean of Neutralizing antibody assay after treatment of 8 patients
837725|NCT01267422|O1|Outcome|The Mean of Neutralizing Antibody Assay Before Treatment|The mean of Neutralizing antibody assay before treatment of 8 patients
837726|NCT01267422|O2|Outcome|IOP After Treatment|Ophthalmologic examinations includes IOP of 9 participants after treatment
837727|NCT01267422|O1|Outcome|IOP Before Treatment|Ophthalmologic examinations includes IOP of 9 paticipants before treatment
837728|NCT01267422|O2|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ After Treatment|The mean percentage of CD3+ after treatment;The mean percentage of CD4+ after treatment;The mean percentage of CD8+ after treatment
837729|NCT01267422|O1|Outcome|The Mean Percentage of CD3+/CD4+/CD8+ Before Treatment|The mean percentage of CD3+ before treatment;The mean percentage of CD4+ before treatment;The mean percentage of CD8+ before treatment
837730|NCT01267422|O2|Outcome|BCVA of Treated Eyes|BCVA of trearted eyes in 9 patients
837731|NCT01267422|O1|Outcome|BCVA of Un-treated Eyes|BCVA of un-treated eyes in 9 patients
837732|NCT01267422|E2|Reported Event|Long-term Affects|Lens may be injured after intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Blood and urine routine is affected.Liver and kidney function is affected.Immune response after surgery.
837733|NCT01267422|E1|Reported Event|Short-term Affects|Lens may be injured during intravitreal injection, and cataract is probably complicated. Retinal detachment or endophthalmitis may be complicated due to retina injury.IOP raised.Endophthalmitis after treament. Hyper-susceptibility or immune response during surgery or after surgery.
837734|NCT01267292|B3|Baseline|Total|Total of all reporting groups
837735|NCT01267292|B2|Baseline|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837736|NCT01267292|B1|Baseline|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837805|NCT01267227|P3|Participant Flow|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
837806|NCT01267227|P2|Participant Flow|Low Dose|Pterostilbene 50 mg twice daily
837807|NCT01267227|P1|Participant Flow|High Dose|Pterostilbene 125 mg twice daily
837737|NCT01267292|P2|Participant Flow|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837738|NCT01267292|P1|Participant Flow|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837739|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837740|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837781|NCT01267266|O1|Outcome|Arm I (Saracatinib)|"Patients receive oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally"
837782|NCT01267266|E3|Reported Event|Placebo, Randomized Phase|Patients receive placebo once daily on days 1-28.
837783|NCT01267266|E2|Reported Event|Saracatinib, Randomized Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
838541|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
837741|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837742|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837743|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837744|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837745|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837808|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily
837809|NCT01267227|O3|Outcome|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
837810|NCT01267227|O2|Outcome|Low Dose|Pterostilbene 50 mg twice daily
837811|NCT01267227|O1|Outcome|High Dose|Pterostilbene 125 mg twice daily
837812|NCT01267227|O4|Outcome|Placebo|Matching placebo twice daily. Unadjusted change from baseline.
837746|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837747|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837748|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837749|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837750|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837784|NCT01267266|E1|Reported Event|Saracatinib, Lead-in Phase|Patients receive 175 mg oral saracatinib once daily on days 1-28.
837785|NCT01267253|B1|Baseline|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837751|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837752|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837753|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837754|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837755|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837756|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837757|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837758|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837759|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837760|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837786|NCT01267253|P1|Participant Flow|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837787|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837761|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837762|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837763|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837764|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837765|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837766|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837767|NCT01267292|O2|Outcome|Placebo for Buspirone Plus Methylphenidate|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837768|NCT01267292|O1|Outcome|Buspirone Plus Methylphenidate|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday; no Methylphenidate or Methylphenidate placebo] [week 2: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; 0mg Methylphenidate (placebo) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday; Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
837769|NCT01267292|E2|Reported Event|Placebo|"week 1: Placebo BID weeks 2-3: Placebo BID~Placebo: week 1 = placebo BID weeks 2-3 = placebo BID"
837770|NCT01267292|E1|Reported Event|Buspirone|"week 1: Buspirone 30 mg BID weeks 2-3: Buspirone 45 mg BID~Buspirone: week 1 = 30 mg BID weeks 2-3 = 45 mg BID"
837771|NCT01267266|B1|Baseline|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
837772|NCT01267266|P2|Participant Flow|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
837773|NCT01267266|P1|Participant Flow|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
837774|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
837775|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
837776|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
837777|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
837778|NCT01267266|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily on days 1-28.
837779|NCT01267266|O1|Outcome|Arm I (Saracatinib)|Patients receive 175 mg oral saracatinib once daily on days 1-28.
837780|NCT01267266|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo once daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Upon progression, patients may crossover to arm I.~hydrocortisone/placebo: Given orally"
837788|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837789|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837790|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837791|NCT01267253|O1|Outcome|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837792|NCT01267253|E1|Reported Event|Brivanib|Brivanib 800mg administered orally every day on days 1 to 28 of each cycle until disease progression or adverse effects prohibit further treatment. One cycle is 28 days.
837793|NCT01267240|B1|Baseline|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
837794|NCT01267240|P1|Participant Flow|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
837795|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
837796|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
837797|NCT01267240|O1|Outcome|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
837798|NCT01267240|E1|Reported Event|Arm I (Capecitabine, Vorinostat)|"Patients receive capecitabine PO BID and vorinostat PO daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Capecitabine: Given PO~Vorinostat: Given PO"
837799|NCT01267227|B5|Baseline|Total|Total of all reporting groups
837800|NCT01267227|B4|Baseline|Placebo|Matching placebo twice daily
837801|NCT01267227|B3|Baseline|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
837802|NCT01267227|B2|Baseline|Low Dose|Pterostilbene 50 mg twice daily
837803|NCT01267227|B1|Baseline|High Dose|Pterostilbene 125 mg twice daily
837804|NCT01267227|P4|Participant Flow|Placebo|Matching placebo twice daily
837817|NCT01267227|E3|Reported Event|Low Dose Combination|Pterostilbene 50 mg/Grape Extract 100 mg twice daily
837818|NCT01267227|E2|Reported Event|Low Dose|Pterostilbene 50 mg twice daily
837819|NCT01267227|E1|Reported Event|High Dose|Pterostilbene 125 mg twice daily
837820|NCT01267201|B1|Baseline|Entire Study Population|Includes all participants randomized to receive methylprednisolone 32 mg tablet first, formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) first and formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) first.
837821|NCT01267201|P6|Participant Flow|Methylprednisolone Formulation 2, Formulation 1, 32 mg Tablet|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
837822|NCT01267201|P5|Participant Flow|Methylprednisolone Formulation 2, 32 mg Tablet, Formulation 1|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
837823|NCT01267201|P4|Participant Flow|Methylprednisolone Formulation 1, Formulation 2, 32 mg Tablet|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single oral dose of methylprednisolone 32 mg tablet on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
837855|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
838217|NCT01266031|P2|Participant Flow|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
837824|NCT01267201|P3|Participant Flow|Methylprednisolone Formulation 1, 32 mg Tablet, Formulation 2|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in first intervention period; followed by single oral dose of methylprednisolone 32 mg tablet on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
837825|NCT01267201|P2|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 2, Formulation 1|Single oral dose of methylprednisolone 32 mg tablet on Day 1 in first intervention period; followed by single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in second intervention period; and single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
837826|NCT01267201|P1|Participant Flow|Methylprednisolone 32 mg Tablet, Formulation 1, Formulation 2|Single oral dose of methylprednisolone 32 milligram (mg) tablet on Day 1 in first intervention period; followed by single dose of formulation 1: methylprednisolone oral suspension 4 milligram/milliliter (mg/mL) at 32 mg (Micronized active pharmaceutical ingredient [API]) on Day 1 in second intervention period; and single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 in third intervention period. A washout period of at least 2 days was maintained between each intervention period.
837827|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
837828|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
837829|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
837830|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
837831|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
837832|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
837833|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
837834|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
837835|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
837836|NCT01267201|O3|Outcome|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
837837|NCT01267201|O2|Outcome|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
837838|NCT01267201|O1|Outcome|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
837839|NCT01267201|E3|Reported Event|Methylprednisolone 32 mg Sieve Cut API|Single dose of formulation 2: methylprednisolone oral suspension 4 mg/mL at 32 mg (Sieve cut API) on Day 1 of any of the three intervention periods.
837972|NCT01266876|P1|Participant Flow|Placebo|Placebo subcutaneous (SC) injection once every two weeks (Q2W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837840|NCT01267201|E2|Reported Event|Methylprednisolone 32 mg Micronized API|Single dose of formulation 1: methylprednisolone oral suspension 4 mg/mL at 32 mg (Micronized API) on Day 1 of any of the three intervention periods.
837841|NCT01267201|E1|Reported Event|Methylprednisolone 32 mg Tablet|Single oral dose of methylprednisolone 32 mg tablet on Day 1 of any of the three intervention periods.
837842|NCT01267175|B1|Baseline|X54 Pump|All subjects transferred from current pump to X54
837843|NCT01267175|P1|Participant Flow|X54 Pump|All subjects transferred from current pump to X54
837844|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
837845|NCT01267175|O1|Outcome|X54 Pump|All subjects transferred from current pump to X54
837846|NCT01267175|E1|Reported Event|X54 Pump|All subjects transferred from current pump to X54
837847|NCT01267136|B3|Baseline|Total|Total of all reporting groups
837848|NCT01267136|B2|Baseline|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
837849|NCT01267136|B1|Baseline|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
837850|NCT01267136|P2|Participant Flow|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day).
837851|NCT01267136|P1|Participant Flow|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
837852|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension: Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
837853|NCT01267136|O1|Outcome|Capital® With Codeine Suspension|Codeine with acetaminophen: Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
837854|NCT01267136|O2|Outcome|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
838323|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
837856|NCT01267136|E2|Reported Event|Tramadol Suspension|Tramadol suspension : Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
837857|NCT01267136|E1|Reported Event|Capital® With Codeine Suspension|Codeine with acetaminophen : Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h PRN (max. of 3 PRN doses/day)
837858|NCT01267045|B3|Baseline|Total|Total of all reporting groups
837859|NCT01267045|B2|Baseline|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837860|NCT01267045|B1|Baseline|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837861|NCT01267045|P2|Participant Flow|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837862|NCT01267045|P1|Participant Flow|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction.~Mindfulness-based stress reduction: A common clinical method of teaching mindfulness is a class series called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837863|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837864|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837865|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837919|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
838299|NCT01265797|B2|Baseline|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
837866|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837867|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837868|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837869|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837870|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837871|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
838542|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
837872|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837873|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837874|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837875|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837876|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837877|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837920|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837921|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837973|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837878|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837879|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837880|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837881|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837882|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837883|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837904|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
837905|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
837906|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
837907|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
838543|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
837884|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837885|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837886|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837887|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837888|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
837889|NCT01267045|O2|Outcome|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837890|NCT01267045|O1|Outcome|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon."
837891|NCT01267045|E2|Reported Event|Arm 2|Treatment as usual for Gulf War Syndrome symptoms (medications, psychotherapy, etc.)
837892|NCT01267045|E1|Reported Event|Arm 1|"Participants in this arm undergo the mindfulness training intervention through taking part in a Mindfulness-Based Stress Reduction course.~The most common clinical method of teaching mindfulness is a standardized class called mindfulness-based stress reduction (MBSR), which is available at over 250 hospitals nationwide. MBSR teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can b"
837893|NCT01267019|B4|Baseline|Total|Total of all reporting groups
837894|NCT01267019|B3|Baseline|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
837895|NCT01267019|B2|Baseline|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
837896|NCT01267019|B1|Baseline|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
837897|NCT01267019|P3|Participant Flow|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
837898|NCT01267019|P2|Participant Flow|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
837899|NCT01267019|P1|Participant Flow|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
837900|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
837901|NCT01267019|O2|Outcome|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
837902|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
837903|NCT01267019|O3|Outcome|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
837908|NCT01267019|O1|Outcome|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
837909|NCT01267019|E3|Reported Event|Arm 3: Non-social Skills|"non-social skills training~non-social skills training: 30 sessions of skills training that has no specific social content"
837910|NCT01267019|E2|Reported Event|Arm 2: Social Cognitive|"social cognitive training~social cognitive training: 30 sessions of social cognitive training without in vivo exercises"
837911|NCT01267019|E1|Reported Event|Arm 1: Vivo Augmentation|"social cognitive training with in vivo augmentation~social cognitive training with in vivo augmentation: 24 sessions of social cognitive training plus 6 sessions of in vivo exercises"
837912|NCT01266967|B3|Baseline|Total|Total of all reporting groups
837913|NCT01266967|B2|Baseline|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837914|NCT01266967|B1|Baseline|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837915|NCT01266967|P2|Participant Flow|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837916|NCT01266967|P1|Participant Flow|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 milligram (mg) capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837917|NCT01266967|O2|Outcome|ThxID BRAF Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the ThxID assay. The RGI test was further validated by BioMerieux (BMX THxID assay) for regulatory approval. The THxID IUO assay was used to retrospectively confirm the RGI test results.
837918|NCT01266967|O1|Outcome|RGI IUO Mutation Positive Participants|Melanoma participants determined to be positive for the BRAF V600E and V600K mutations as determined by the RGI assay. The RGI assay is a BRAF mutation test developed by Response Genetics Incorporated, and was used to determine eligibility. It employs the allele-specific polymerase chain reaction (ASPCR) methodology, and was offered as an Investigational Use Only assay (only for pre-market investigational purposes).
838300|NCT01265797|B1|Baseline|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
837922|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837923|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837924|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837925|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837926|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837927|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837928|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837929|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837930|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837931|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837991|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837932|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837933|NCT01266967|O1|Outcome|GSK2118436 150 mg|Participants with or without prior local therapy for brain metastasis received GSK2118436 50 mg and 75 mg capsules either one hour before or 2 hours after a meal twice daily.
837934|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837935|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837936|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837937|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837938|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837939|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837940|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837941|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837942|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837943|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837944|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
838303|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
837945|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837946|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837947|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837948|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837949|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837950|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837951|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837952|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837953|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837954|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837992|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838324|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
837955|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837956|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837957|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837958|NCT01266967|O2|Outcome|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837959|NCT01266967|O1|Outcome|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837960|NCT01266967|E2|Reported Event|GSK2118436 150 mg: Prior Local Therapy|Participants who received prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837961|NCT01266967|E1|Reported Event|GSK2118436 150 mg: No Prior Local Therapy|Participants who received no prior local therapy for brain metastasis received GSK2118436 150 mg capsules either one hour before or 2 hours after a meal twice daily until evidence of disease progression, death, or unacceptable adverse events.
837962|NCT01266876|B6|Baseline|Total|Total of all reporting groups
837963|NCT01266876|B5|Baseline|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837964|NCT01266876|B4|Baseline|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837965|NCT01266876|B3|Baseline|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837966|NCT01266876|B2|Baseline|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837967|NCT01266876|B1|Baseline|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837968|NCT01266876|P5|Participant Flow|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837969|NCT01266876|P4|Participant Flow|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837970|NCT01266876|P3|Participant Flow|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837971|NCT01266876|P2|Participant Flow|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection once every 4 weeks (Q4W) added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837974|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837975|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837976|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837977|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837978|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837979|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837980|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837981|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837982|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837983|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837984|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837985|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837986|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837987|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837988|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837989|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837990|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838544|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
837993|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837994|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837995|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837996|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837997|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837998|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
837999|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838000|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838001|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838002|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838003|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838004|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838005|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838006|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838007|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838008|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838009|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838010|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838011|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838012|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838013|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838014|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838015|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838016|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838301|NCT01265797|P2|Participant Flow|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
838017|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838018|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838019|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838020|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838021|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838022|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838023|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838024|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838025|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838026|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838027|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838028|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838029|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838030|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838031|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838032|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838033|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838034|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838035|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838036|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838037|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838038|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838039|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838040|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838041|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838042|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838043|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838044|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838045|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838046|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838047|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838048|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838049|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838050|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838051|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838052|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838053|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838054|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838055|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838056|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838057|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838058|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838432|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838059|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838060|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838061|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838062|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838063|NCT01266876|O5|Outcome|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838064|NCT01266876|O4|Outcome|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838065|NCT01266876|O3|Outcome|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838066|NCT01266876|O2|Outcome|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838067|NCT01266876|O1|Outcome|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838068|NCT01266876|E5|Reported Event|Alirocumab 150 mg Q2W|Alirocumab 150 mg SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838069|NCT01266876|E4|Reported Event|Alirocumab 300 mg Q4W|Alirocumab 300 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838070|NCT01266876|E3|Reported Event|Alirocumab 200 mg Q4W|Alirocumab 200 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838071|NCT01266876|E2|Reported Event|Alirocumab 150 mg Q4W|Alirocumab 150 mg SC injection Q4W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838072|NCT01266876|E1|Reported Event|Placebo|Placebo SC injection Q2W added to stable statin regimen with or without concomitant ezetimibe for 12 weeks.
838073|NCT01266850|B6|Baseline|Total|Total of all reporting groups
838074|NCT01266850|B5|Baseline|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received 2-mL Rotarix® orally at 2 months of age, followed by 1-mL RotaTeq® orally at 4 and 6 months of age.
838075|NCT01266850|B4|Baseline|Group 4: Rotarix, Rotarix|Participants received 2-mL Rotarix® orally at 2 and 4 months of age.
838076|NCT01266850|B3|Baseline|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received 2-mL RotaTeq® orally at 2 and 4 months of age, followed by 1-mL Rotarix® orally at 6 months of age.
838120|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838077|NCT01266850|B2|Baseline|Group 2: RotaTeq, Rotarix, Rotarix|Participants received 2-mL RotaTeq® orally at 2 months of age, followed by 1-mL Rotarix® orally at 4 and 6 months of age.
838078|NCT01266850|B1|Baseline|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received 2-mL RotaTeq® orally at 2, 4 and 6 months of age.
838079|NCT01266850|P5|Participant Flow|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838080|NCT01266850|P4|Participant Flow|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838081|NCT01266850|P3|Participant Flow|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838082|NCT01266850|P2|Participant Flow|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838083|NCT01266850|P1|Participant Flow|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838084|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838085|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838086|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838087|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838088|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838089|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838090|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838091|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838092|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838093|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838094|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838095|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838096|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838097|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838098|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838099|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838100|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838101|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838102|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838103|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838104|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838105|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838106|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838107|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838108|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838109|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838110|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838111|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838112|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838113|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838114|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838115|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838116|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838117|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838118|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838119|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838121|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838122|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838123|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838124|NCT01266850|O5|Outcome|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838125|NCT01266850|O4|Outcome|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838126|NCT01266850|O3|Outcome|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838127|NCT01266850|O2|Outcome|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838128|NCT01266850|O1|Outcome|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838129|NCT01266850|E5|Reported Event|Group 5: Rotarix, RotaTeq, RotaTeq|Participants received Rotarix® orally at 2 months of age, followed by RotaTeq® orally at 4 and 6 months of age.
838130|NCT01266850|E4|Reported Event|Group 4: Rotarix, Rotarix|Participants received Rotarix® orally at 2 and 4 months of age.
838131|NCT01266850|E3|Reported Event|Group 3: RotaTeq, RotaTeq, Rotarix|Participants received RotaTeq® orally at 2 and 4 months of age, followed by Rotarix® orally at 6 months of age.
838132|NCT01266850|E2|Reported Event|Group 2: RotaTeq, Rotarix, Rotarix|Participants received RotaTeq® orally at 2 months of age, followed by Rotarix® orally at 4 and 6 months of age.
838133|NCT01266850|E1|Reported Event|Group 1: RotaTeq, RotaTeq, RotaTeq|Participants received RotaTeq® orally at 2, 4 and 6 months of age.
838134|NCT01266824|B3|Baseline|Total|Total of all reporting groups
838135|NCT01266824|B2|Baseline|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
838136|NCT01266824|B1|Baseline|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
838137|NCT01266824|P2|Participant Flow|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
838138|NCT01266824|P1|Participant Flow|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
838139|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
838140|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
838141|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
838165|NCT01266265|E2|Reported Event|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
838142|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
838143|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
838144|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
838145|NCT01266824|O2|Outcome|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
838146|NCT01266824|O1|Outcome|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
838147|NCT01266824|E2|Reported Event|Standard of Care|Infants in this arm will not receive Proparacaine (anesthetic eye drop) prior to mydriatic eye drops.
838148|NCT01266824|E1|Reported Event|Proparacaine|"Infants in this group will receive 1 drop of Proparacaine (anesthetic eye drop) into each eye prior to receiving mydriatic eye drops~Proparacaine Hydrochloride Ophthalmic Solution : 1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops"
838149|NCT01266447|B1|Baseline|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838150|NCT01266447|P1|Participant Flow|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838151|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838152|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838153|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838154|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838155|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838156|NCT01266447|O1|Outcome|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838157|NCT01266447|E1|Reported Event|ABT-888, Topotecan and Filgrastim or Pegfilgrastim|ABT-888 10mg administered orally twice a day on days 1 to 5 of each cycle. Topotecan administered at 0.6 mg/m2 intravenously once daily on days 1 to 5 of each cycle. Each cycle of treatment repeats every 21 days until disease progression or adverse effects prohibit further treatment. All patients will receive filgrastim or pegfilgrastim beginning with cycle 1.
838158|NCT01266265|B3|Baseline|Total|Total of all reporting groups
838159|NCT01266265|B2|Baseline|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
838160|NCT01266265|B1|Baseline|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
838161|NCT01266265|P2|Participant Flow|Control|"The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of Baseline visit, but treated with any other FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: As prescribed by the physician prostacyclin: As prescribed by the physician subcutaneous and intravenous prostacyclin: As prescribed by physician oral ERA: As prescribed by physician oral PDE5 inhibitors: As prescribed by physician"
838162|NCT01266265|P1|Participant Flow|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
838163|NCT01266265|O2|Outcome|Control|The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
838164|NCT01266265|O1|Outcome|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
838166|NCT01266265|E1|Reported Event|Tyvaso|"The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.~inhaled prostacyclin: Tyvaso"
838167|NCT01266148|B3|Baseline|Total|Total of all reporting groups
838168|NCT01266148|B2|Baseline|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838169|NCT01266148|B1|Baseline|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838170|NCT01266148|P2|Participant Flow|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838171|NCT01266148|P1|Participant Flow|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838172|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838173|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838174|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838175|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838176|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838177|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838178|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838179|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838180|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838181|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838182|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838183|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838184|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838185|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838186|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838187|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838188|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838189|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838190|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838191|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838192|NCT01266148|O2|Outcome|Control|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study.
838193|NCT01266148|O1|Outcome|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838194|NCT01266148|E2|Reported Event|Everolimus|Participants started immunosuppressive regimen consisting of low dose CsA, everolimus, MMF and CS. After week 11, the participants regimen consisted of everolimus, MMF and CS.
838195|NCT01266148|E1|Reported Event|Controls|Participants received an immunosuppressive regimen consisting of CsA, MMF and CS throughout the study
838196|NCT01266122|B3|Baseline|Total|Total of all reporting groups
838197|NCT01266122|B2|Baseline|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
838198|NCT01266122|B1|Baseline|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
838199|NCT01266122|P2|Participant Flow|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
838200|NCT01266122|P1|Participant Flow|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
838233|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|"Includes subjects with sensitive disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more."
838302|NCT01265797|P1|Participant Flow|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
838201|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
838202|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
838203|NCT01266122|O2|Outcome|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
838204|NCT01266122|O1|Outcome|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
838205|NCT01266122|E2|Reported Event|Behavioral Intervention|"Participants enrolled in the experimental condition will receive 4 group sessions and 4 individual sessions over 3 months. This intervention focuses on psychosocial concerns and HIV risk for MSM in India.~Behavioral intervention: The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk."
838206|NCT01266122|E1|Reported Event|HIV/STI Voluntary Counseling and Testing|Participants enrolled in the control arm will receive study assessments only.
838207|NCT01266070|B1|Baseline|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
838208|NCT01266070|P1|Participant Flow|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
838209|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
838210|NCT01266070|O1|Outcome|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
838211|NCT01266070|E1|Reported Event|Dovitinib|Dovitinib oral 500 mg/day on a 5 day on, 2 day off schedule (Days 1-5, 8-12, 15-19, and 22-26) of each 28-day cycle
838212|NCT01266031|B4|Baseline|Total|Total of all reporting groups
838213|NCT01266031|B3|Baseline|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
838214|NCT01266031|B2|Baseline|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose by vein on days 1 and 15 of a 28 day cycle.
838215|NCT01266031|B1|Baseline|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 and days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 + 15 of 28 day cycle.
838216|NCT01266031|P3|Participant Flow|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
838218|NCT01266031|P1|Participant Flow|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
838219|NCT01266031|O1|Outcome|Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
838220|NCT01266031|O2|Outcome|Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
838221|NCT01266031|O1|Outcome|Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
838222|NCT01266031|E3|Reported Event|Phase II: Bevacizumab + Vorinostat 400 mg|Phase II Bevacizumab 10 mg/kg/dose IV Day 1 & 15 + MTD of Vorinostat 400 mg/day by mouth on days 1 to 7 & days 15 to 21 of a 28 day cycle.
838223|NCT01266031|E2|Reported Event|Phase II: Bevacizumab|Phase II Bevacizumab 10 mg/kg/dose IV on days 1 & 15 of a 28 day cycle.
838224|NCT01266031|E1|Reported Event|Phase I: Vorinostat + Bevacizumab|Phase I Vorinostat starting dose 400 mg orally days 1 - 7 & days 15 - 21 in combination with Bevacizumab fixed dose 10mg/kg IV on Days 1 & 15 of 28 day cycle.
838225|NCT01266018|B1|Baseline|All Enrolled Subjects|Includes all subjects enrolled in Cohort 1 (n = 9) and Cohort 2 (n = 13).
838226|NCT01266018|P2|Participant Flow|Cohort 2: Refractory Disease|Cohort 2 comprised subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response
838227|NCT01266018|P1|Participant Flow|Cohort 1: Sensitive Disease|Cohort 1 comprised subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
838228|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|Includes subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
838229|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|Includes subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
838230|NCT01266018|O1|Outcome|All Subjects (Pharmacodynamic Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.
838231|NCT01266018|O1|Outcome|All Subjects (Pharmacodynamic Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 12) who received at least 1 dose of study drug and provided plasma samples for pharmacodynamic analyses.
838232|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|"Includes subjects with refractory disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response."
838270|NCT01265875|E1|Reported Event|Human Secretin|Human Secretin : Dose Escalation within participant
838234|NCT01266018|O2|Outcome|Cohort 2: Refractory Disease|Includes subjects with “refractory” disease, defined as subjects who either (a) were treated with 1 previous line of chemotherapy and either had no response or progressed < 90 days after completing treatment or (b) required third-line therapy, i.e., had completed 2 previous lines of chemotherapy, regardless of response.
838235|NCT01266018|O1|Outcome|Cohort 1: Sensitive Disease|Includes subjects with “sensitive” disease, defined as subjects who were treated with 1 previous line of chemotherapy and maintained an appropriate response for 90 days or more.
838236|NCT01266018|E1|Reported Event|All Subjects (Safety Analysis Set)|Includes all subjects in Cohort 1 (n = 9) and Cohort 2 (n = 13) who received at least 1 dose of study drug.
838237|NCT01265992|B1|Baseline|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838238|NCT01265992|P1|Participant Flow|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 chronic kidney disease (CKD) and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838239|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838240|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838241|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838242|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838243|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838244|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838245|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838325|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
838246|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838247|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838248|NCT01265992|O1|Outcome|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838249|NCT01265992|E1|Reported Event|Paricalcitol Capsules|Patients with secondary hyperparathyroidism associated with Stage 3 - 5 CKD and not yet on dialysis and prescribed paricalcitol capsules in accordance with the terms of the marketing authorization in Sweden.
838250|NCT01265966|B4|Baseline|Total|Total of all reporting groups
838251|NCT01265966|B3|Baseline|General Anesthesia|Children undergoing general anesthesia for procedures.
838252|NCT01265966|B2|Baseline|Deep Sedation|Children undergoing deep sedation for procedures.
838253|NCT01265966|B1|Baseline|Moderate Sedation|Children undergoing moderate sedation for procedures.
838254|NCT01265966|P3|Participant Flow|General Anesthesia|Children undergoing general anesthesia for procedures.
838255|NCT01265966|P2|Participant Flow|Deep Sedation|Children undergoing deep sedation for procedures.
838256|NCT01265966|P1|Participant Flow|Moderate Sedation|Children undergoing moderate sedation for procedures.
838257|NCT01265966|O3|Outcome|General Anesthesia|Children undergoing general anesthesia for procedures.
838258|NCT01265966|O2|Outcome|Deep Sedation|Children undergoing deep sedation for procedures.
838259|NCT01265966|O1|Outcome|Moderate Sedation|Children undergoing moderate sedation for procedures.
838260|NCT01265966|E3|Reported Event|General Anesthesia|Children undergoing general anesthesia for procedures.
838261|NCT01265966|E2|Reported Event|Deep Sedation|Children undergoing deep sedation for procedures.
838262|NCT01265966|E1|Reported Event|Moderate Sedation|Children undergoing moderate sedation for procedures.
838263|NCT01265875|B1|Baseline|Human Secretin|Human Secretin : Dose Escalation
838264|NCT01265875|P1|Participant Flow|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
838265|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
838266|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
838267|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
838268|NCT01265875|O1|Outcome|Human Secretin|"Human Secretin : Dose Escalation~There were 3 days of dosing, 3 doses per day. This was a dose escalation within the participant and did not exceed 0.8mcg/kg, which is within safe limits."
838269|NCT01265875|O1|Outcome|Human Secretin|Human Secretin : Dose Escalation
838271|NCT01265823|B1|Baseline|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838272|NCT01265823|P1|Participant Flow|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838273|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838274|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838275|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838276|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838277|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838278|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838279|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as those with a waist-hip ratio of ≤1 for men and ≤0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838280|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as those with a waist-hip ratio of >1 for men and >0.8 for women. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838281|NCT01265823|O2|Outcome|Adalimumab in Non-obese Participants|Non-obese participants were defined as having a BMI < 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838326|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
838282|NCT01265823|O1|Outcome|Adalimumab in Obese Participants|Obese participants were defined as having a BMI ≥ 30. Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838283|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838284|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838285|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838286|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838287|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838288|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838289|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838290|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838291|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838292|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838293|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838294|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838295|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838296|NCT01265823|O1|Outcome|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838297|NCT01265823|E1|Reported Event|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
838298|NCT01265797|B3|Baseline|Total|Total of all reporting groups
838304|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
838305|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
838306|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
838307|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
838308|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
838309|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
838310|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
838311|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
838312|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
838313|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
838314|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
838315|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
838316|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
838317|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
838318|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
838319|NCT01265797|O2|Outcome|Sham|Sham: wears sham cranial electrostimulation device for 20 minutes daily for 28 days
838320|NCT01265797|O1|Outcome|Verum|Verum : wears active cranial electrostimulation device for 20 minutes daily for 28 days
838321|NCT01265797|O2|Outcome|Sham|Sham Device : wears Sham device daily for 20 minutes for 28 days
838322|NCT01265797|O1|Outcome|Verum|Verum : wears active Electrostimulator device daily for 20 minutes for 28 days
838327|NCT01265797|E2|Reported Event|Sham|Sham: wears sham cranial electrostimulation (CES) device for 20 minutes daily for 28 days
838328|NCT01265797|E1|Reported Event|Verum|Verum : wears active cranial electrostimulation (CES) device for 20 minutes daily for 28 days
838329|NCT01265784|B4|Baseline|Total|Total of all reporting groups
838330|NCT01265784|B3|Baseline|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838331|NCT01265784|B2|Baseline|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838332|NCT01265784|B1|Baseline|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838333|NCT01265784|P3|Participant Flow|Ertapenem, 1 g q24h|Ertapenem was administered IV at a dose of 1 gram (g) q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838334|NCT01265784|P2|Participant Flow|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg every 12 hours (q12h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838335|NCT01265784|P1|Participant Flow|TP-434, 1.5 mg/kg q24h|TP-434 was administered intravenously (IV) at a dose of 1.5 milligrams per kilogram of body weight (mg/kg) every 24 hours (q24h) for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838336|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838337|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838338|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838339|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838340|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838341|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838342|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838343|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838344|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838345|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838346|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838347|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838348|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838349|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838350|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838433|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838351|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838352|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838353|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838354|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838355|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838356|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838357|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838358|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838359|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838360|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838361|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838362|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838452|NCT01265615|E1|Reported Event|Paricalcitol Treatment|6-8 μg daily per os without special diet
838363|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838364|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838365|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838366|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838367|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838368|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838369|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838370|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838371|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838372|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838373|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838374|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838375|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838376|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838377|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838378|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838379|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838380|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838381|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838382|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838383|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838384|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838385|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838519|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838386|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838387|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838388|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838389|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838390|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838391|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838392|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838393|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838394|NCT01265784|O3|Outcome|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838395|NCT01265784|O2|Outcome|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838396|NCT01265784|O1|Outcome|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838397|NCT01265784|E3|Reported Event|Ertapenem 1 g q24h|Ertapenem was administered IV at a dose of 1 g q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838398|NCT01265784|E2|Reported Event|TP-434, 1.0 mg/kg q12h|TP-434 was administered IV at a dose of 1.0 mg/kg q12h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838399|NCT01265784|E1|Reported Event|TP-434, 1.5 mg/kg q24h|TP-434 was administered IV at a dose of 1.5 mg/kg q24h for a minimum of 4 days and a maximum of 14 days (7 days for participants in India).
838400|NCT01265615|B5|Baseline|Total|Total of all reporting groups
838401|NCT01265615|B4|Baseline|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838402|NCT01265615|B3|Baseline|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838403|NCT01265615|B2|Baseline|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838404|NCT01265615|B1|Baseline|Paricalcitol Treatment|6-8 μg daily per os without special diet
838405|NCT01265615|P4|Participant Flow|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838406|NCT01265615|P3|Participant Flow|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838407|NCT01265615|P2|Participant Flow|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838408|NCT01265615|P1|Participant Flow|Paricalcitol Treatment|6-8 μg daily per os without special diet
838409|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838410|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838411|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838412|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838413|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838414|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838415|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838416|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838417|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838418|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838419|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838420|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838421|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838422|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838423|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838424|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838425|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838426|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838427|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838428|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838429|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838430|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838431|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838434|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838435|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838436|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838437|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838438|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838439|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838440|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838441|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838442|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838443|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838444|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838445|NCT01265615|O4|Outcome|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838446|NCT01265615|O3|Outcome|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838447|NCT01265615|O2|Outcome|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838448|NCT01265615|O1|Outcome|Paricalcitol Treatment|6-8 μg daily per os without special diet
838449|NCT01265615|E4|Reported Event|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
838450|NCT01265615|E3|Reported Event|Cholecalciferol|alendronate sodium/ cholecalciferol capsules with recommended daily allowance equals 1200-2400 IU per day
838451|NCT01265615|E2|Reported Event|Calcitriol Treatment|2-4 μg daily orally under with dietary restrictions of vitamin D
838454|NCT01265563|B5|Baseline|NAC Active and High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838455|NCT01265563|B4|Baseline|NAC Active and Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838456|NCT01265563|B3|Baseline|NAC Placebo and Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838457|NCT01265563|B2|Baseline|NAC Active and Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838458|NCT01265563|B1|Baseline|NAC Placebo and Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
838459|NCT01265563|P5|Participant Flow|NAC Active + High Dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838460|NCT01265563|P4|Participant Flow|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838473|NCT01265563|O1|Outcome|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
838461|NCT01265563|P3|Participant Flow|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838462|NCT01265563|P2|Participant Flow|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838463|NCT01265563|P1|Participant Flow|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
838464|NCT01265563|O5|Outcome|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838465|NCT01265563|O4|Outcome|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838466|NCT01265563|O3|Outcome|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838467|NCT01265563|O2|Outcome|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838468|NCT01265563|O1|Outcome|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
838469|NCT01265563|O5|Outcome|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838470|NCT01265563|O4|Outcome|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838471|NCT01265563|O3|Outcome|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838472|NCT01265563|O2|Outcome|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838518|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838474|NCT01265563|E5|Reported Event|NAC Active + High-dose Silibin Active|"N-acetylcysteine active + high-dose silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: high-dose silibin 960 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos~N-acetylcysteine active + high-dose silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838475|NCT01265563|E4|Reported Event|NAC Active + Silibin Active|"N-acetylcysteine active + silibin active Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin active: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months~(Other Name): NAC Dietary Supplement: silibin 480 mg orally twice daily for three months Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months~(Other Name): Silibin-phosphatidylcholine, Siliphos Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838476|NCT01265563|E3|Reported Event|NAC Placebo + Silibin Active|"N-acetylcysteine placebo + silibin active Dietary Supplement: silibin 480 mg orally twice daily for three months Other Name: silibin-phosphatidylcholine, Siliphos Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin active: Dietary Supplement: silibin 480 mg orally twice daily for three months~(Other Name) Silibin-phosphatidylcholine placebo, Siliphos placebo~(Other Name) NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months"
838477|NCT01265563|E2|Reported Event|NAC Active + Silibin Placebo|"N-acetylcysteine active + silibin placebo Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months Other Name: NAC Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine active + silibin placebo: Dietary Supplement: N-acetylcysteine 600 mg orally twice daily for three months"
838545|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838478|NCT01265563|E1|Reported Event|NAC Placebo + Silibin Placebo|"N-acetylcysteine placebo + silibin placebo Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months Other Name: NAC placebo Dietary Supplement: silibin placebo excipient orally twice daily for three months Other Name: silibin-phosphatidylcholine placebo, Siliphos placebo~N-acetylcysteine placebo + silibin placebo: Dietary Supplement: N-acetylcysteine placebo excipient orally twice daily for three months"
838479|NCT01265524|B3|Baseline|Total|Total of all reporting groups
838480|NCT01265524|B2|Baseline|Placebo|Placebo: capsules
838481|NCT01265524|B1|Baseline|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838482|NCT01265524|P2|Participant Flow|Placebo|Placebo: capsules
838483|NCT01265524|P1|Participant Flow|Investigational Drug: CLP|Investigational drug: 15 g CLP per day given as capsules
838484|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
838485|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838486|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
838487|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838488|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
838489|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838490|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
838491|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838492|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
838493|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838494|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
838495|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838496|NCT01265524|O2|Outcome|Placebo|Placebo: capsules
838497|NCT01265524|O1|Outcome|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838498|NCT01265524|E2|Reported Event|Placebo|Placebo: capsules
838499|NCT01265524|E1|Reported Event|Investigational Drug: CLP|Investigational drug: 15g CLP per day given as capsules
838500|NCT01265498|B3|Baseline|Total|Total of all reporting groups
838501|NCT01265498|B2|Baseline|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838502|NCT01265498|B1|Baseline|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838503|NCT01265498|P2|Participant Flow|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838504|NCT01265498|P1|Participant Flow|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838505|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838506|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838507|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838508|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838509|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838510|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838511|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838512|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838513|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838514|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838515|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838516|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838517|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838520|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838521|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838522|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838523|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838524|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838525|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838526|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838527|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838528|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838529|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838530|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838531|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838532|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838533|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838534|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838535|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838536|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838537|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838538|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838539|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838540|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838546|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838547|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838548|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838549|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838550|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838551|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838552|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838553|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838554|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838555|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838556|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838557|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838558|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838559|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838560|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838561|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838562|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838563|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838564|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838565|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838566|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838567|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838568|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838569|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838570|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838571|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838572|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838573|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838574|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838575|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838576|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838577|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838578|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838579|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838580|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838581|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838582|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838583|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838584|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838585|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838586|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838587|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838588|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838589|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838590|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838591|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838592|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838593|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838594|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838595|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838596|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838597|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838598|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838599|NCT01265498|O2|Outcome|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838600|NCT01265498|O1|Outcome|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838601|NCT01265498|E2|Reported Event|Placebo|"Placebo~placebo: placebo capsule, 25 mg daily for 72 weeks"
838602|NCT01265498|E1|Reported Event|Obeticholic Acid|"obeticholic acid~obeticholic acid: 25 mg daily for 72 weeks"
838603|NCT01265459|B4|Baseline|Total|Total of all reporting groups
838604|NCT01265459|B3|Baseline|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838605|NCT01265459|B2|Baseline|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838606|NCT01265459|B1|Baseline|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838607|NCT01265459|P3|Participant Flow|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838608|NCT01265459|P2|Participant Flow|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838609|NCT01265459|P1|Participant Flow|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838610|NCT01265459|O3|Outcome|Durolane 6 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
838611|NCT01265459|O2|Outcome|Durolane 4.5 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
838612|NCT01265459|O1|Outcome|Durolane 3 mL|"Subject´s global assessment of the status of the study knee at 26 weeks (change from baseline).~Single injection of Durolane (20 mg/ml)."
838613|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
838614|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
838615|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC physical function score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
838616|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
838617|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
838618|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC stiffness score at 26 weeks (change from baseline). Single injection of Durolane (20 mg/ml).
838619|NCT01265459|O3|Outcome|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838620|NCT01265459|O2|Outcome|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838621|NCT01265459|O1|Outcome|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838622|NCT01265459|O3|Outcome|Durolane 6 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
838623|NCT01265459|O2|Outcome|Durolane 4.5 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
838624|NCT01265459|O1|Outcome|Durolane 3 mL|WOMAC pain score at 26 weeks (change from baseline). Single intra-articular injection of Durolane (20mg/ml).
838625|NCT01265459|E3|Reported Event|Durolane 6 mL|Single injection of 6 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838626|NCT01265459|E2|Reported Event|Durolane 4.5 mL|Single injection of 4.5 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838627|NCT01265459|E1|Reported Event|Durolane 3 mL|Single injection of 3 ml Durolane (Durolane is an intraarticular hyaluronic acid preparation)
838628|NCT01265446|B3|Baseline|Total|Total of all reporting groups
838629|NCT01265446|B2|Baseline|Lidocaine 1mg + CPC 2mg|one single dose
838630|NCT01265446|B1|Baseline|Lidocaine 8mg +CPC 2mg|one single dose
838631|NCT01265446|P2|Participant Flow|Lidocaine 1mg + CPC 2mg|one single dose
838632|NCT01265446|P1|Participant Flow|Lidocaine 8mg +CPC 2mg|one single dose
838633|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
838634|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
838635|NCT01265446|O2|Outcome|Lidocaine 1mg + CPC 2mg|one single dose
838636|NCT01265446|O1|Outcome|Lidocaine 8mg +CPC 2mg|one single dose
838637|NCT01265446|E2|Reported Event|Lidocaine 1mg + CPC 2mg|one single dose
838638|NCT01265446|E1|Reported Event|Lidocaine 8mg +CPC 2mg|one single dose
838639|NCT01265420|B1|Baseline|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
838640|NCT01265420|P1|Participant Flow|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
838641|NCT01265420|O1|Outcome|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
838733|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838642|NCT01265420|E1|Reported Event|Injectable Clostridial Collagenase|Patients were treated with 0.58 mg clostridial collagenase into palpable cord in 1st webspace
838643|NCT01265394|B1|Baseline|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
838644|NCT01265394|P1|Participant Flow|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
838645|NCT01265394|O1|Outcome|(18F) Flutemetamol Injection|Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
838646|NCT01265394|O1|Outcome|Normal and Abnormal Reads With or Without Amyloid|Each Subject received a dose of [18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
838647|NCT01265394|E1|Reported Event|(18F) Flutemetamol|[18F] Flutemetamol : Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
838648|NCT01265056|B3|Baseline|Total|Total of all reporting groups
838649|NCT01265056|B2|Baseline|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
838650|NCT01265056|B1|Baseline|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
838651|NCT01265056|P2|Participant Flow|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
838652|NCT01265056|P1|Participant Flow|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
838653|NCT01265056|O2|Outcome|Gabapentin|Patients received gabapentin.
838654|NCT01265056|O1|Outcome|Placebo|Patients received a sugar pill similar to gabapentin.
838655|NCT01265056|E2|Reported Event|Gabapentin|Patients in this group received gabapentin which looked just like the sugar pill.
838656|NCT01265056|E1|Reported Event|Sugar Pill|Patients in this group received a sugar pill which looked identical to gabapentin.
838657|NCT01264952|B4|Baseline|Total|Total of all reporting groups
838760|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
838761|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838762|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838658|NCT01264952|B3|Baseline|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
838659|NCT01264952|B2|Baseline|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
838660|NCT01264952|B1|Baseline|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
838661|NCT01264952|P3|Participant Flow|Group III|The third group included patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
838662|NCT01264952|P2|Participant Flow|Group II|The second group (group II) included patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
838663|NCT01264952|P1|Participant Flow|Group I|The first group included patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
838664|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
838665|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
838666|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
838667|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
838699|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838734|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838668|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
838669|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
838670|NCT01264952|O3|Outcome|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
838671|NCT01264952|O2|Outcome|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
838672|NCT01264952|O1|Outcome|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
838673|NCT01264952|E3|Reported Event|Group III|Patients with up to three metachronous, unresectable liver metastases, demanding too excessive resection, or untreatable by standard thermal ablative methods, due to the close proximity of major blood vessels. Electrochemotherapy was offered to these patients as the only treatment option.
838674|NCT01264952|E2|Reported Event|Group II|Patients with synchronous metastases, but their general condition and extent of the disease did not allow simultaneous removal of the primary tumor and metastases. During the first operation, the primary tumor was removed (colorectal resection) and some of the liver metastases were treated by electrochemotherapy. About 6 weeks later, during the second operation for liver metastases, both treated and non‐treated metastases were removed with liver resection.
838675|NCT01264952|E1|Reported Event|Group I|Patients with bilateral, multiple, metachronous metastases in whom standard treatment included twostage liver resection, due to the extent of the disease and/or their general condition. During the first operation, right portal vein was ligated and metastases on the left side were excised or ablated with radiofrequency ablation. At the same time, up to three metastases on the right side were treated with electrochemotherapy. During the second operation, both treated and non‐treated metastases on the right side were removed with right hemihepatectomy.
838676|NCT01264939|B3|Baseline|Total|Total of all reporting groups
838677|NCT01264939|B2|Baseline|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838678|NCT01264939|B1|Baseline|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838679|NCT01264939|P2|Participant Flow|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838680|NCT01264939|P1|Participant Flow|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838681|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838682|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838683|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838684|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838685|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838686|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838687|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838688|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838689|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838690|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838691|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838692|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838693|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838694|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838695|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838696|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838697|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838698|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838700|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838701|NCT01264939|O2|Outcome|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838702|NCT01264939|O1|Outcome|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838703|NCT01264939|E2|Reported Event|Omalizumab 300 mg|Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
838704|NCT01264939|E1|Reported Event|Placebo|Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period.
838705|NCT01264887|B1|Baseline|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838706|NCT01264887|P1|Participant Flow|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838707|NCT01264887|O1|Outcome|Frequency of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838708|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838763|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838764|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838709|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838710|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838711|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838712|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838713|NCT01264887|O1|Outcome|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838714|NCT01264887|O1|Outcome|Number of Treatment Emergent Adverse Events|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838715|NCT01264887|E1|Reported Event|Tapentadol Prolonged Release|All participants from the KF5503/15 that enrolled into this trial were on tapentadol prolonged release. Participants were dosed in the range of 100 to 250 mg tapentadol twice daily. The dose was titrated to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerated and wishes to continue treatment.
838716|NCT01264835|B1|Baseline|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
838717|NCT01264835|P1|Participant Flow|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
838718|NCT01264835|O1|Outcome|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
838719|NCT01264835|E1|Reported Event|Slotted Anoscope|Subjects consenting to have hemorrhoidectomy with the slotted anoscope
838720|NCT01264770|B7|Baseline|Total|Total of all reporting groups
838721|NCT01264770|B6|Baseline|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
838722|NCT01264770|B5|Baseline|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
838723|NCT01264770|B4|Baseline|ADALIMUMAB 40 MG SC|Dosing Group D
838724|NCT01264770|B3|Baseline|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
838725|NCT01264770|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
838726|NCT01264770|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
838727|NCT01264770|P6|Participant Flow|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO|Dosing Group G
838728|NCT01264770|P5|Participant Flow|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO|Dosing Group F
838729|NCT01264770|P4|Participant Flow|ADALIMUMAB 40 MG SC|Dosing Group D
838730|NCT01264770|P3|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO|Dosing Group C
838731|NCT01264770|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
838732|NCT01264770|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
838736|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838737|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838738|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838739|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838740|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838741|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838742|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838743|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838744|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838745|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838746|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838747|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838748|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838749|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838750|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838751|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
838752|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838753|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838754|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838755|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838756|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838757|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838758|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838759|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838765|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838766|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838767|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
838768|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838769|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838770|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838771|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838772|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838773|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838774|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
838775|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838776|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838777|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838778|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838779|NCT01264770|O7|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838780|NCT01264770|O6|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838781|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
838782|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838783|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838784|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838785|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838786|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838787|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838788|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838789|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838790|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838791|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838792|NCT01264770|O5|Outcome|Dosing Group E|PLACEBO (COMBINED)
838793|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838794|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838795|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838796|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838797|NCT01264770|O6|Outcome|Dosing Group G|PLACEBO (6 WK) THEN FOSTA 100 MG BID (4 WK) THEN 150 MG QD PO
838798|NCT01264770|O5|Outcome|Dosing Group F|PLACEBO (6 WKS) THEN FOSTA 100 MG BID PO
838799|NCT01264770|O4|Outcome|Dosing Group D|ADALIMUMAB 40 MG SC
838800|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838801|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838802|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838803|NCT01264770|O4|Outcome|Dosing Group E|PLACEBO (COMBINED)
838804|NCT01264770|O3|Outcome|Dosing Group C|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD PO
838805|NCT01264770|O2|Outcome|Dosing Group B|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO
838806|NCT01264770|O1|Outcome|Dosing Group A|FOSTA 100 MG BID PO
838807|NCT01264770|E8|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - Placebo Period|
838808|NCT01264770|E7|Reported Event|PLACEBO (6 WKS) THEN FOSTA 100 MG BID - FOSTA Period|
838809|NCT01264770|E6|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-PBO Period|
838810|NCT01264770|E5|Reported Event|PLACEBO (6 WKS) FOSTA 100 MG BID (4 WKS) 150 MG QD-FOSTAperiod|
838811|NCT01264770|E4|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|
838812|NCT01264770|E3|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 100 MG QD|Dosing Group C
838813|NCT01264770|E2|Reported Event|FOSTA 100 MG BID|Dosing Group A
838814|NCT01264770|E1|Reported Event|ADALIMUMAB 40 MG|Dosing Group D
838815|NCT01264614|B3|Baseline|Total|Total of all reporting groups
838816|NCT01264614|B2|Baseline|Normative Older Adults|Normative older adults with no known history of neurological condition.
838817|NCT01264614|B1|Baseline|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838818|NCT01264614|P2|Participant Flow|Normative Older Adults|Normative older adults with no known history of neurological condition.
838819|NCT01264614|P1|Participant Flow|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838820|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
838821|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838822|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
838823|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838824|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
838825|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838826|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
838827|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838828|NCT01264614|O2|Outcome|Normative Older Adults|Normative older adults with no known history of neurological condition.
838829|NCT01264614|O1|Outcome|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838830|NCT01264614|E2|Reported Event|Normative Older Adults|Normative older adults with no known history of neurological condition.
838831|NCT01264614|E1|Reported Event|Early Stage Dementia|Individuals with early stage dementia who attended a Adult Day Care Program at least twice a week.
838832|NCT01264380|B1|Baseline|All Participants|Included all participants who received single oral dose of vemurafenib tablet at 960 mg in fasted condition first and fed condition first in Period A and Period B and twice daily dose of vemurafenib tablet at 960 mg in Period C.
838833|NCT01264380|P3|Participant Flow|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
838834|NCT01264380|P2|Participant Flow|Vemurafenib (RO5185426): Fed Then Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fasted condition Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
838835|NCT01264380|P1|Participant Flow|Vemurafenib (RO5185426): Fasted Then Fed|Single oral dose of vemurafenib tablet at 960 milligrams (mg) on Day 1 was administered to participants in fasted condition (Period A [Day 1 to Day 10]) followed by single oral dose of vemurafenib tablet at 960 mg on Day 1 in fed condition (Period B [Day 11 to Day 20]). A washout period of 10 days was maintained between Period A and B.
838836|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
838837|NCT01264380|O1|Outcome|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
838838|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838839|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838840|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838841|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838842|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838843|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838844|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838845|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838846|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838847|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838848|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838849|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838850|NCT01264380|O2|Outcome|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838906|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
838851|NCT01264380|O1|Outcome|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 mg on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838852|NCT01264380|E3|Reported Event|Vemurafenib (RO5185426)|Participants received vemurafenib tablet at 960 mg orally twice daily in 21-day cycles starting from Day 21 until disease progression, unacceptable toxicity, or consent withdrawal (Period C).
838853|NCT01264380|E2|Reported Event|Vemurafenib (RO5185426): Fed|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fed condition, in any intervention periods (Period A or B).
838854|NCT01264380|E1|Reported Event|Vemurafenib (RO5185426): Fasted|Single oral dose of vemurafenib tablet at 960 milligram (mg) on Day 1 was administered to participants in fasted condition, in any intervention periods (Period A or B).
838855|NCT01264081|B1|Baseline|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
838856|NCT01264081|P1|Participant Flow|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
838857|NCT01264081|O1|Outcome|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
838858|NCT01264081|O1|Outcome|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
838859|NCT01264081|E1|Reported Event|Group A|Lapatinib: 500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
838860|NCT01264016|B1|Baseline|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.
838861|NCT01264016|P1|Participant Flow|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
838862|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
838863|NCT01264016|O1|Outcome|Study Staff Test Subject Venous Blood|Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood.
838864|NCT01264016|O1|Outcome|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
838865|NCT01264016|E1|Reported Event|Intended Users of the Monitoring System|Untrained subjects with diabetes use an investigational blood glucose monitoring system.
838866|NCT01263925|B3|Baseline|Total|Total of all reporting groups
838867|NCT01263925|B2|Baseline|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838868|NCT01263925|B1|Baseline|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838869|NCT01263925|P2|Participant Flow|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838870|NCT01263925|P1|Participant Flow|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838871|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838872|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838873|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838874|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838907|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
838875|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838876|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838877|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838878|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838879|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
839114|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
838880|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838881|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838882|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838883|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838884|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838885|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838886|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838887|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838888|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
841894|NCT01258387|B2|Baseline|GGF2 First Dose|First dosing: patients in cohort randomized to GGF2
838889|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838890|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838891|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838892|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838893|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838919|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838894|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838895|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838896|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838897|NCT01263925|O2|Outcome|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838898|NCT01263925|O1|Outcome|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838899|NCT01263925|E2|Reported Event|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
838900|NCT01263925|E1|Reported Event|Alprostadil|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets.~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 μg) of Prostaglandin E1 (total 60 μg) in 50 - 250 ml physiological saline solution over 2 hours and in addition 2 x daily (including weekends) Placebo tablets."
838901|NCT01263873|B3|Baseline|Total|Total of all reporting groups
838902|NCT01263873|B2|Baseline|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
838903|NCT01263873|B1|Baseline|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
838904|NCT01263873|P2|Participant Flow|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
838905|NCT01263873|P1|Participant Flow|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
839248|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
838908|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
838909|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
838910|NCT01263873|O2|Outcome|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
838911|NCT01263873|O1|Outcome|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
838912|NCT01263873|E2|Reported Event|Mallinckrodt® Endotracheal Tube|Standard PVC Mallinckrodt® tube used throughout the world for intubating the trachea St. Louis, MO 63134.
838913|NCT01263873|E1|Reported Event|Parker Flex Tip Endotracheal Tube|Parker Flex-Tip® which is a disposable polyvinyl chloride (PVC) Endotracheal tube with a flexible, tapered tip that is anatomically designed to the airway structures.
838914|NCT01263717|B3|Baseline|Total|Total of all reporting groups
838915|NCT01263717|B2|Baseline|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838916|NCT01263717|B1|Baseline|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838917|NCT01263717|P2|Participant Flow|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838918|NCT01263717|P1|Participant Flow|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
839221|NCT01263496|B5|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
838920|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838921|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838922|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838923|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838924|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838925|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838926|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838927|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838928|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838929|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838930|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838931|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838932|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838933|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838934|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838935|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838936|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838937|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838938|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838939|NCT01263717|O2|Outcome|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
839249|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
838940|NCT01263717|O1|Outcome|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838941|NCT01263717|E2|Reported Event|Placebo (Inactive Injection)|Placebo 2mg daily given subcutaneously for the first 6 months of the study, followed by 6 months of tesamorelin (growth hormone releasing hormone) 2mg daily during an open label phase
838942|NCT01263717|E1|Reported Event|Tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given subcutaneously x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
838943|NCT01263691|B7|Baseline|Total|Total of all reporting groups
838944|NCT01263691|B6|Baseline|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
838945|NCT01263691|B5|Baseline|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838946|NCT01263691|B4|Baseline|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838947|NCT01263691|B3|Baseline|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838948|NCT01263691|B2|Baseline|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838949|NCT01263691|B1|Baseline|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
838950|NCT01263691|P6|Participant Flow|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
838951|NCT01263691|P5|Participant Flow|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
843338|NCT01253980|P2|Participant Flow|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
838952|NCT01263691|P4|Participant Flow|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838953|NCT01263691|P3|Participant Flow|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838954|NCT01263691|P2|Participant Flow|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL anthrax vaccine adsorbed [AVA] + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838955|NCT01263691|P1|Participant Flow|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
838956|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838957|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838958|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838959|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838960|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838961|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838962|NCT01263691|O18|Outcome|Female Saline|Female participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838963|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838980|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
838981|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838964|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838965|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838966|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838967|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838968|NCT01263691|O12|Outcome|Male Saline|Male participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838969|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838995|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839222|NCT01263496|B4|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
838970|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838971|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838972|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838973|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838974|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838975|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838976|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838977|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838978|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838979|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
838982|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838983|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838984|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838985|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
838986|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
838987|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838988|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838989|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838990|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838991|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
838992|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
838993|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838994|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838996|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
838997|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
838998|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
838999|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839000|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839001|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839002|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839003|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839004|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
839005|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839006|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839007|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839008|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839009|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839010|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
839011|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839012|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839013|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839014|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839015|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839016|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
839017|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839018|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839019|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839020|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839021|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839022|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
839023|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839024|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839025|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839026|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839027|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839028|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
839029|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839030|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839031|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839032|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839033|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839034|NCT01263691|O18|Outcome|Female Saline|Female Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839035|NCT01263691|O17|Outcome|Female AV7909 Formulation 4|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839036|NCT01263691|O16|Outcome|Female AV7909 Formulation 3|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839037|NCT01263691|O15|Outcome|Female AV7909 Formulation 2|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839038|NCT01263691|O14|Outcome|Female AV7909 Formulation 1|Female Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839039|NCT01263691|O13|Outcome|Female BioThrax|Female Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839040|NCT01263691|O12|Outcome|Male Saline|Male Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839041|NCT01263691|O11|Outcome|Male AV7909 Formulation 4|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839042|NCT01263691|O10|Outcome|Male AV7909 Formulation 3|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839070|NCT01263639|B2|Baseline|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
839043|NCT01263691|O9|Outcome|Male AV7909 Formulation 2|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839044|NCT01263691|O8|Outcome|Male AV7909 Formulation 1|Male Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839045|NCT01263691|O7|Outcome|Male BioThrax|Male Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839046|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839047|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839048|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839049|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839050|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839051|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14 Antibody titers were assessed in the immunogenicity population, which included subjects who received both vaccinations, had immunogenicity data within the allowable window, and had no protocol violations that could affect TNA values (n=100).
839052|NCT01263691|O6|Outcome|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
839053|NCT01263691|O5|Outcome|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839054|NCT01263691|O4|Outcome|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839055|NCT01263691|O3|Outcome|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839056|NCT01263691|O2|Outcome|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839057|NCT01263691|O1|Outcome|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839058|NCT01263691|E6|Reported Event|Saline|Participants between 18 and 50 years of age who received two doses of saline placebo (0.5 mL) IM on Days 0 and 14
839059|NCT01263691|E5|Reported Event|AV7909 Formulation 4|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 4 (0.25 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839060|NCT01263691|E4|Reported Event|AV7909 Formulation 3|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 3 (0.25 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839061|NCT01263691|E3|Reported Event|AV7909 Formulation 2|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 2 (0.5 mL AVA + 0.25 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839062|NCT01263691|E2|Reported Event|AV7909 Formulation 1|Participants between 18 and 50 years of age who received two doses of AV7909 Formulation 1 (0.5 mL AVA + 0.5 mg CPG 7909; total volume 0.5 mL) IM on Days 0 and 14
839063|NCT01263691|E1|Reported Event|BioThrax|Participants between 18 and 50 years of age who received two doses of BioThrax (0.5 mL) intramuscularly (IM) on Days 0 and 14
839064|NCT01263665|B1|Baseline|Investigational Arm|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
839065|NCT01263665|P1|Participant Flow|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|"25 cm length GORE® VIABAHN® Endoprosthesis with~> PROPATEN Bioactive Surface Subjects"
839066|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
839067|NCT01263665|O1|Outcome|25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac|25 cm length GORE® VIABAHN® Endoprosthesis with > PROPATEN Bioactive Surface Subjects
839068|NCT01263665|E1|Reported Event|25 cm GORE VIABAHN|25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
839069|NCT01263639|B3|Baseline|Total|Total of all reporting groups
839071|NCT01263639|B1|Baseline|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
839072|NCT01263639|P2|Participant Flow|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
839073|NCT01263639|P1|Participant Flow|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
839074|NCT01263639|O2|Outcome|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
839075|NCT01263639|O1|Outcome|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
839076|NCT01263639|E2|Reported Event|Control Group, Standard Care|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The control group will receive the usual/standard care as provided to all orthopaedic trauma admission patients without receiving a biosketch card."
839113|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
843339|NCT01253980|P1|Participant Flow|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
839077|NCT01263639|E1|Reported Event|Intervention Group, Biosketch Card|The investigators aim to improve the patient-physician relationship and improve patient satisfaction by providing a biosketch card of the attending orthopaedic trauma surgeon to the patient. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies.
839078|NCT01263561|B3|Baseline|Total|Total of all reporting groups
839079|NCT01263561|B2|Baseline|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
839080|NCT01263561|B1|Baseline|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
839081|NCT01263561|P2|Participant Flow|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
839082|NCT01263561|P1|Participant Flow|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
839083|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
839084|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
839085|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
839086|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
839087|NCT01263561|O2|Outcome|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
839088|NCT01263561|O1|Outcome|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
839089|NCT01263561|E2|Reported Event|ExPRESS|"ExPRESS miniature glaucoma drainage device~ExPRESS shunt: ExPRESS miniature glaucoma drainage device"
839090|NCT01263561|E1|Reported Event|Trabeculectomy|"trabeculectomy filtering surgery~trabeculectomy: trabeculectomy filtering surgery"
839091|NCT01263509|B3|Baseline|Total|Total of all reporting groups
839092|NCT01263509|B2|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839093|NCT01263509|B1|Baseline|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839094|NCT01263509|P4|Participant Flow|α-glucosidase Monotherapy Group*→ 25 mg Combination Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
839095|NCT01263509|P3|Participant Flow|α-glucosidase Monotherapy Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the α-glucosidase inhibitor monotherapy dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
839096|NCT01263509|P2|Participant Flow|25 mg Combination Dose Group* → 25 mg Combination Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the for 25 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
839097|NCT01263509|P1|Participant Flow|12.5 mg Combination Dose Group* → 12.5 mg Combination Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg combination dosing ARM of the SYR-322/CCT-003 (NCT01263483) core phase 2/3 add on study."
839098|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839246|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839099|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839100|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839101|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839102|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839103|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839104|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839105|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839106|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839107|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839108|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839109|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839110|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839111|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839112|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839115|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839116|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839117|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839118|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839119|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839120|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839121|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839122|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839123|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839124|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839125|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839126|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839127|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839128|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839129|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839130|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839131|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839132|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839133|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839134|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839135|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839247|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839136|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839137|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839138|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839139|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839140|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839141|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839142|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839143|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839144|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839145|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839146|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839147|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839148|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839149|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839223|NCT01263496|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839150|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839151|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839152|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839153|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839154|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839155|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839156|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839157|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839158|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839159|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839160|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839161|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839162|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839163|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839164|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839165|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839166|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839167|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839168|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839169|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839170|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839171|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839172|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839173|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839174|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839175|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839176|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839177|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839178|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839179|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839180|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839181|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839182|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839183|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839184|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839224|NCT01263496|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839185|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839186|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839187|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839188|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839189|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839190|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839191|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839192|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839193|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839194|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839195|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839196|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839197|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839198|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839199|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839200|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839201|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839202|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839203|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839204|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839205|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839206|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839207|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839208|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839209|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839210|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839211|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839212|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839213|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839214|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839215|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839216|NCT01263509|O2|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839217|NCT01263509|O1|Outcome|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839218|NCT01263509|E2|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839219|NCT01263509|E1|Reported Event|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839220|NCT01263496|B6|Baseline|Total|Total of all reporting groups
839225|NCT01263496|B1|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839226|NCT01263496|P9|Participant Flow|Placebo Dose Group* → Alogliptin 50 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839227|NCT01263496|P8|Participant Flow|Placebo Dose Group* → Alogliptin 25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839228|NCT01263496|P7|Participant Flow|Placebo Dose Group* → Alogliptin 12.5 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839229|NCT01263496|P6|Participant Flow|Placebo Dose Group* → Alogliptin 6.25 mg Dose Group|"Placebo-matching tablets, orally, once or three times daily for up to 40 weeks.~*for participants from the placebo dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839230|NCT01263496|P5|Participant Flow|Voglibose 0.2 mg Dose Group* → Voglibose 0.2 mg Dose Group|"Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the voglibose 0.2 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839231|NCT01263496|P4|Participant Flow|Alogliptin 50 mg Dose Group* → Alogliptin 50 mg Dose Group|"Alogliptin 50 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 50 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839232|NCT01263496|P3|Participant Flow|Alogliptin 25 mg Dose Group* → Alogliptin 25 mg Dose Group|"Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 25 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839233|NCT01263496|P2|Participant Flow|Alogliptin 12.5 mg Dose Group* → Alogliptin 12.5 mg Dose Group|"Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 12.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839234|NCT01263496|P1|Participant Flow|Alogliptin 6.25 mg Dose Group* → Alogliptin 6.25 mg Dose Group|"Alogliptin 6.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.~*for participants from the 6.5 mg dosing ARM of the SYR-322/CCT-001 (NCT01263470) dose-ranging study."
839235|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839236|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839237|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839238|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839239|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839240|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839241|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839242|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839243|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839244|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839245|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839250|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839251|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839252|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839253|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839254|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839255|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839256|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839257|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839258|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839259|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839260|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839261|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839262|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839263|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839264|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839265|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839266|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839267|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839268|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839269|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839270|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839271|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839272|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839273|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839274|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839275|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839276|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839277|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839278|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839279|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839280|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839281|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839282|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839283|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839284|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839285|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839286|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839287|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839288|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839289|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839290|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839291|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839292|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839293|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839294|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839295|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839296|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839297|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839298|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839299|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839300|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839301|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839302|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839303|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839304|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839305|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839306|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839307|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839308|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839309|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839310|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839311|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839312|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839313|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839314|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839315|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839316|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839317|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839318|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839319|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839320|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839321|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839322|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839323|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839324|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839325|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839326|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839327|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839328|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839329|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839330|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839331|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839332|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839333|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839334|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839335|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839336|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839337|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839338|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839339|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839340|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839341|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839342|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839343|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839344|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839345|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839346|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839347|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839348|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839349|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839350|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839351|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839352|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839353|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839354|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839355|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839356|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839357|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839358|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839359|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839360|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839361|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839362|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839363|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839364|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839365|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839366|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839367|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839368|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839369|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839370|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839371|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839372|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839373|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839374|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839375|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839376|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839377|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839378|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839379|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839380|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839381|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839382|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839383|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839384|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839385|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839386|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839387|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839388|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839389|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839390|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839391|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839392|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839393|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839394|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839395|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839396|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839397|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839398|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839399|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839400|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839401|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839402|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839403|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839404|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839405|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839406|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839407|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839408|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839409|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839410|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839411|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839412|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839413|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839414|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839415|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839416|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839417|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839418|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839419|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839420|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839421|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839422|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839423|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839424|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839425|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839426|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839427|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839428|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839429|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839430|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839431|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839432|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839433|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839434|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839435|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839436|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839437|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839438|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839439|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839440|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839441|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839442|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839443|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839444|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839445|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839446|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839447|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839448|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839449|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839450|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839451|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839452|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839453|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839454|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839455|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839456|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839457|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839458|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839459|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839460|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839461|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839462|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839463|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839464|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839465|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839466|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839467|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839468|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839469|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839470|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839471|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839472|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839473|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839474|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839475|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839476|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839477|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839478|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839479|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839480|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839481|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839482|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839483|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839484|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839485|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839486|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839487|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839488|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839489|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839490|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839491|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839492|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839493|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839494|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839495|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839496|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839497|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839498|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839499|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839500|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839501|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839502|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839503|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839504|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839505|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839506|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839507|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839508|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839509|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839510|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839511|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839512|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839513|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839514|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839515|NCT01263496|O5|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839516|NCT01263496|O4|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839517|NCT01263496|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839518|NCT01263496|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839519|NCT01263496|O1|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839520|NCT01263496|E5|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
839521|NCT01263496|E4|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
839522|NCT01263496|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
839523|NCT01263496|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
839524|NCT01263496|E1|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
839525|NCT01263483|B4|Baseline|Total|Total of all reporting groups
839526|NCT01263483|B3|Baseline|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839527|NCT01263483|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839528|NCT01263483|B1|Baseline|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839529|NCT01263483|P3|Participant Flow|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839530|NCT01263483|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839531|NCT01263483|P1|Participant Flow|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839532|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839533|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839534|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839578|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839535|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839536|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839537|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839538|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839539|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839540|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839541|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839542|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839543|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839544|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839545|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839546|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839547|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839548|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839549|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839550|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839551|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839552|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839553|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839554|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839555|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839556|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839557|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839558|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839559|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839560|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839561|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839562|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839563|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839564|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839565|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839566|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839567|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839568|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839569|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839570|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839571|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839572|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839573|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839574|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839575|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839576|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839577|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839579|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839580|NCT01263483|O3|Outcome|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839581|NCT01263483|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839582|NCT01263483|O1|Outcome|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839583|NCT01263483|E3|Reported Event|Alogliptin 25 mg QD and Voglibose 0.2 mg TID|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839584|NCT01263483|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID
839585|NCT01263483|E1|Reported Event|Voglibose 0.2 mg TID|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839586|NCT01263470|B7|Baseline|Total|Total of all reporting groups
839587|NCT01263470|B6|Baseline|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839588|NCT01263470|B5|Baseline|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839589|NCT01263470|B4|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839590|NCT01263470|B3|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839591|NCT01263470|B2|Baseline|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839592|NCT01263470|B1|Baseline|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839593|NCT01263470|P6|Participant Flow|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839594|NCT01263470|P5|Participant Flow|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839595|NCT01263470|P4|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839596|NCT01263470|P3|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839597|NCT01263470|P2|Participant Flow|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839598|NCT01263470|P1|Participant Flow|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839599|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839600|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839601|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839602|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839603|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839604|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839605|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839606|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839607|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839608|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839609|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839610|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839611|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839612|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839613|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839614|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839615|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839616|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839617|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839618|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839619|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839620|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839621|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839622|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839623|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839624|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839625|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839626|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839627|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839628|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839629|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839630|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839631|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839632|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839633|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839634|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839635|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839636|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839637|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839638|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839639|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839640|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839641|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839642|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839643|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839644|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839645|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839646|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839647|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839648|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839649|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839650|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839651|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839652|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839653|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839654|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839655|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839656|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839657|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839658|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839659|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839660|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839661|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839662|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839663|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839664|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839665|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839666|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839667|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839668|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839669|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839670|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839671|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839672|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839673|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839674|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839675|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839676|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839677|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839678|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839679|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839680|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839681|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839682|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839683|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839684|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839685|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839686|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839687|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839688|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839689|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839690|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839691|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839692|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839693|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839694|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839695|NCT01263470|O6|Outcome|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839696|NCT01263470|O5|Outcome|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839697|NCT01263470|O4|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839698|NCT01263470|O3|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839699|NCT01263470|O2|Outcome|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839700|NCT01263470|O1|Outcome|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839701|NCT01263470|E6|Reported Event|Voglibose 0.2 mg TID|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
839702|NCT01263470|E5|Reported Event|Alogliptin 50 mg QD|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks.
839703|NCT01263470|E4|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
839704|NCT01263470|E3|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
839705|NCT01263470|E2|Reported Event|Alogliptin 6.25 mg QD|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks.
839706|NCT01263470|E1|Reported Event|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
839707|NCT01263444|B1|Baseline|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
839708|NCT01263444|P1|Participant Flow|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
839709|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
839710|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
839711|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
839712|NCT01263444|O1|Outcome|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
839713|NCT01263444|E1|Reported Event|Azarga|Brinzolamide 1% / timolol 0.5% Fixed Combination administered as 1 drop in study eye(s) twice a day (8:00 AM and 8:00 PM) for 12 weeks, at a 5 minute interval from the habitual prostaglandin monotherapy.
839714|NCT01263301|B3|Baseline|Total|Total of all reporting groups
841895|NCT01258387|B1|Baseline|Placebo|Patients in each of 7 cohorts randomized to Placebo
839715|NCT01263301|B2|Baseline|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
839716|NCT01263301|B1|Baseline|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
839717|NCT01263301|P2|Participant Flow|Carotid Duplex for Hemodialytic Patients|"After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of vertebral artery and subclavian artery in the ipsilateral side of vascular access.~However, before carotid duplex, we didn't know which patients will show SSS.All 11 hemodialytic patients completed the study but only 2 showed the results of SSS. And for further analysis, we used these only 2."
839718|NCT01263301|P1|Participant Flow|Carotid Duplex for Nonhemidialytic Patients Wtih SSS|using carotid duplex to study vertebral and subclavian artery, using cuff test to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test for patients in the two groups
839719|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow remained unchanged during the test
839720|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow remained unchanged during the test
839721|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have vertebral arterial flow reversed to normal pattern during the test
840264|NCT01262092|P2|Participant Flow|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
839722|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study vertebral arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have vertebral arterial flow reversed to normal during the test
839723|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow remained unchanged during the cuff test
839724|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow remained unchanged during the cuff test
839725|NCT01263301|O2|Outcome|Hemodialytic Patients With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many patients with vascular access will have subclavian arterial flow reversed to normal pattern during the test
839726|NCT01263301|O1|Outcome|Normal Parcipitants With Subclavian Steal|we use carotid duplex to study subclavian arterial flow before and during cuff test that stopped the flow in arm to see how many normal patients without vascular access will have subclavian arterial flow reversed to normal during the test
839727|NCT01263301|E2|Reported Event|Carotid Duplex for Hemodialytic Patients With SSS|After receiving written consent from patients with vascular access in the forearm, carotid duplex was done to especially see the flow pattern and direction of flow of vertebral artery and subclavian artery in the ipsilateral side of vascular access during and after the stop of flow in the arm by cuff test.
839728|NCT01263301|E1|Reported Event|Carotid Duplex for Nonhemodialytic Patients Wtih SSS|using carotid duplex (with cuff test) to study vertebral and subclavian artery to see the difference of flow during and after occlusion of blood vessel in the arm by cuff test
839729|NCT01263132|B3|Baseline|Total|Total of all reporting groups
839730|NCT01263132|B2|Baseline|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839731|NCT01263132|B1|Baseline|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
839732|NCT01263132|P2|Participant Flow|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839733|NCT01263132|P1|Participant Flow|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
839734|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839735|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
839736|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839737|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
843841|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
839738|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839739|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
839740|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839741|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
839742|NCT01263132|O2|Outcome|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839743|NCT01263132|O1|Outcome|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
839744|NCT01263132|E2|Reported Event|MF0434 + Gabapentin|MF0434 and Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week and then dose increased up to 3 weeks as per dosage adjustment schedule.
839745|NCT01263132|E1|Reported Event|Gabapentin|Gabapentin 300 mg capsule was taken orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose for one week; and then dose increased up to 3 weeks as per dosage adjustment schedule.
839746|NCT01263054|B3|Baseline|Total|Total of all reporting groups
839747|NCT01263054|B2|Baseline|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
839748|NCT01263054|B1|Baseline|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
839749|NCT01263054|P2|Participant Flow|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
839750|NCT01263054|P1|Participant Flow|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
839751|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
839752|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
839753|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
839754|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
839755|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
839756|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
839757|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
839758|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
839759|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
839760|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
839761|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
839762|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
839763|NCT01263054|O2|Outcome|Medical Management|Standard Medical Management
839764|NCT01263054|O1|Outcome|TransDiscal System|Kimberly-Clark TransDiscal System in addition to standard medical management
839765|NCT01263054|E2|Reported Event|Medical Management|"Standard medical management~Medical Management: Standard medical management, physical therapy, and lifestyle changes."
839766|NCT01263054|E1|Reported Event|TransDiscal System|"Kimberly-Clark TransDiscal System in addition to standard medical management~TransDiscal System: Surgical Procedure using the TransDiscal System to perform disc biacuplasty."
839767|NCT01263028|B1|Baseline|Ergocalciferol Supplementation|
839768|NCT01263028|P1|Participant Flow|Ergocalciferol Supplementation|
839769|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
839770|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
839771|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
839772|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
840097|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
839773|NCT01263028|O1|Outcome|Ergocalciferol Supplementation|Ergocalciferol will be administered as 50,000 international units (IU) weekly regardless of Serum 25-hydroxy Vitamin D levels for 12 weeks. Then 50,000 IU every other week. If 25-hydroxy Vitamin D levels are below goal of 40ng/ml, subjects will continue on 50,000 IU ergocalciferol weekly until levels of 40ng/ml, are achieved.
839774|NCT01263028|E1|Reported Event|Ergocalciferol Supplementation|
839775|NCT01263015|B3|Baseline|Total|Total of all reporting groups
839776|NCT01263015|B2|Baseline|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839777|NCT01263015|B1|Baseline|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839778|NCT01263015|P2|Participant Flow|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks.
839779|NCT01263015|P1|Participant Flow|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks.
839780|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
840050|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840263|NCT01262092|B1|Baseline|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
839781|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839782|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839783|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839784|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839785|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839786|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839787|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839788|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839789|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839790|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839791|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839792|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839793|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839794|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839795|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839796|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
840170|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
839797|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839798|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839799|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839800|NCT01263015|O2|Outcome|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839801|NCT01263015|O1|Outcome|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839802|NCT01263015|E2|Reported Event|EFV/TDF/FTC 600/200/300 mg Once Daily|During double-blind phase, participants received EFV/TDF/FTC 600/200/300 mg OD, with placebo to match DTG 50 mg and ABC/3TC 600/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive EFV/TDF/FTC 600/200/300 mg OD for additional 48 weeks during open-label phase.
839803|NCT01263015|E1|Reported Event|DTG 50 mg Plus ABC/3TC 600/300 mg Once Daily|During double-blind phase, participants received a dolutegravir (DTG) 50 milligram (mg) tablet along with an Abacavir/Lamivudine (ABC/3TC) 600/300 mg tablet once daily (OD) orally, with placebo to match Efavirenz/Tenofovir disoproxil fumarate/Emtricitabine (EFV/TDF/FTC) 600/200/300 mg for 96 weeks. Participants who completed double-blind phase continued to receive DTG 50 mg tablet along with ABC/3TC 600/300 mg tablet OD orally, for additional 48 weeks during open-label phase.
839804|NCT01262989|B1|Baseline|Participants Receiving Both Test Product and Reference Product|Participants receiving either test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days) or reference product in Period 1 and test product in Period 2
839805|NCT01262989|P2|Participant Flow|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
840098|NCT01262820|E1|Reported Event|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
846778|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
839806|NCT01262989|P1|Participant Flow|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
839807|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
839808|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
839809|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
839810|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
839811|NCT01262989|O2|Outcome|Reference Product|Reference product SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
839812|NCT01262989|O1|Outcome|Test Product|Test product tamsulosin hydrochloride 0.4 milligrams (mg) prolonged released hard gelatin capsule, once a day, in both periods (duration of 3 days in each period)
839813|NCT01262989|E2|Reported Event|Reference Product in Period 1; Test Product in Period 2|Reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by test product: tamsulosin hydrochloride 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
839814|NCT01262989|E1|Reported Event|Test Product in Period 1; Reference Product in Period 2|Test product: tamsulosin hydrochloride 0.4 milligrams (mg) prolonged release hard gelatin capsule, once a day, in Period 1 (duration of 3 days); followed by a 7-day washout period during which no medication was administered; followed by reference product: SECOTEX (tamsulosin hydrochloride) 0.4 mg prolonged release hard gelatin capsule, once a day, in Period 2 (duration of 3 days)
839815|NCT01262872|B9|Baseline|Total|Total of all reporting groups
840051|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840619|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
839816|NCT01262872|B8|Baseline|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839817|NCT01262872|B7|Baseline|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839818|NCT01262872|B6|Baseline|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839819|NCT01262872|B5|Baseline|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839820|NCT01262872|B4|Baseline|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
846779|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
839821|NCT01262872|B3|Baseline|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839822|NCT01262872|B2|Baseline|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
839823|NCT01262872|B1|Baseline|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
839824|NCT01262872|P8|Participant Flow|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839825|NCT01262872|P7|Participant Flow|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840620|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
839826|NCT01262872|P6|Participant Flow|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839827|NCT01262872|P5|Participant Flow|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839828|NCT01262872|P4|Participant Flow|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839829|NCT01262872|P3|Participant Flow|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839830|NCT01262872|P2|Participant Flow|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
839831|NCT01262872|P1|Participant Flow|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840155|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
839832|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839833|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839834|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839835|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840052|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
839836|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839837|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839838|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839839|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840099|NCT01262755|B1|Baseline|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
840710|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
839840|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839841|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839842|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839843|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839844|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839845|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839846|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839847|NCT01262872|O5|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839858|NCT01262872|O2|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839848|NCT01262872|O4|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839849|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839850|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839851|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839852|NCT01262872|O1|Outcome|Total “All 5” Group|A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded).
839853|NCT01262872|O1|Outcome|Total “All 5” Group|A subset of samples selected for ply and phtD gene sequencing of S. pneumoniae isolates, isolated from nasopharyngeal samples across all time points and across study groups of Cohort 2 (Prev13_3 group was excluded).
839854|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840081|NCT01262872|E2|Reported Event|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
839855|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839856|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839857|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839859|NCT01262872|O1|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839860|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839861|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839862|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839863|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840171|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
839864|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839865|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839866|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839893|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839867|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839868|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839869|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839870|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839871|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839872|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840621|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
839873|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839874|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839875|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839876|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839877|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839878|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839879|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839880|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839881|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840211|NCT01262287|E1|Reported Event|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
839882|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839883|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839965|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839884|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839885|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839886|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839887|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839888|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839889|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839890|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840212|NCT01262131|B4|Baseline|Total|Total of all reporting groups
839891|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839892|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839894|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839895|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839896|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839897|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839898|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839899|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840213|NCT01262131|B3|Baseline|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
839900|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839901|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839902|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839903|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839904|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839905|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839906|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839907|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839908|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840214|NCT01262131|B2|Baseline|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
839909|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839910|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839911|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839912|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839913|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839914|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839915|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839916|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839917|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840215|NCT01262131|B1|Baseline|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
839918|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839919|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839920|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839921|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839922|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839923|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839924|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839925|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839926|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839927|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839928|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839955|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839929|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839930|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839931|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839932|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839933|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839934|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839935|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839936|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839964|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839937|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839938|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839939|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839940|NCT01262872|O4|Outcome|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839941|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839942|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839943|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839953|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839944|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839945|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839946|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839947|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839948|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839949|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839950|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839951|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839952|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839954|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840128|NCT01262547|O3|Outcome|Control|Target sites did not receive any treatment
839956|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839957|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839958|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839959|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839960|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839961|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839962|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840216|NCT01262131|P3|Participant Flow|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
839963|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840060|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840061|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
839966|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839967|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839968|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839969|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839970|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839971|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840217|NCT01262131|P2|Participant Flow|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
839972|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839973|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839974|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839975|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839976|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839977|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839978|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839979|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839980|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840218|NCT01262131|P1|Participant Flow|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
839981|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839982|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839983|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839984|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839985|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839986|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839987|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839988|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839989|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840219|NCT01262131|O3|Outcome|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
839990|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
839991|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839992|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839993|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839994|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839995|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally
839996|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839997|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
839998|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840220|NCT01262131|O2|Outcome|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
839999|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840000|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840001|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840002|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840003|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840004|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840005|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840006|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840007|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840221|NCT01262131|O1|Outcome|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
840008|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840009|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840010|NCT01262872|O2|Outcome|Synflorix 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840011|NCT01262872|O1|Outcome|10PP-HD 2+1D Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840012|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840013|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840014|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840015|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840016|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840222|NCT01262131|E3|Reported Event|Inactive Resonator|Application of inactive magnetic fields using the Resonator device
840017|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840018|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840019|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840020|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840021|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840022|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840023|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840024|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840025|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840223|NCT01262131|E2|Reported Event|Resonator Protocol B|Application of magnetic fields using the Resonator device treatment protocol B
840026|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840027|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840028|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840029|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840030|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840031|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840032|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840033|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840034|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840224|NCT01262131|E1|Reported Event|Resonator Protocol A|Application of magnetic fields using the Resonator device protocol A
840035|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840036|NCT01262872|O4|Outcome|Prevnar13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840037|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840038|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840039|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840040|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840041|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840042|NCT01262872|O2|Outcome|Prevnar13 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840043|NCT01262872|O1|Outcome|10PP-HD 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840044|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840045|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840046|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840047|NCT01262872|O1|Outcome|10PP-HD 1d|Group This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840048|NCT01262872|O2|Outcome|Prevnar13 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840049|NCT01262872|O1|Outcome|10PP-HD 1D Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840225|NCT01262118|B3|Baseline|Total|Total of all reporting groups
840053|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840054|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840055|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840056|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840057|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840058|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840059|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840129|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
840062|NCT01262872|O2|Outcome|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840063|NCT01262872|O1|Outcome|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840064|NCT01262872|O3|Outcome|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840065|NCT01262872|O2|Outcome|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840066|NCT01262872|O1|Outcome|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840067|NCT01262872|O2|Outcome|Prevnar 13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840068|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840069|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840070|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840071|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840072|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840073|NCT01262872|O2|Outcome|Prevnar13 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of Prevnar 13™ at Day 0. Prevnar 13™ was administered intramuscularly in the non-dominant deltoid.
840074|NCT01262872|O1|Outcome|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840094|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
840095|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
840096|NCT01262820|O1|Outcome|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
846780|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
840075|NCT01262872|E8|Reported Event|Synflorix 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received Synflorix™ and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the Synflorix™ co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of Synflorix™ co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840076|NCT01262872|E7|Reported Event|10PP-HD 2+1d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received the GSK 2189242A (or 10PP) vaccine, in its high-dose (HD) formulation, and EPI vaccines according to a 2+1 Schedule. That is, subjects received 2 doses of the 10PP vaccine, HD formulation co-administered with Tritanrix™-Hep B/Hib and Polio Sabin™ at 2-4 months of age (at Day 0 and Month 2), followed by a third dose of the same formulation co-administered with M-Vac™, Stamaril™ and Polio Sabin™ at approximately 9 months of age.. The 2nd doses of Tritanrix™-Hep B/Hib and Polio Sabin™ in EPI vaccines were administered without any pneumococcal vaccine at 3 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840077|NCT01262872|E6|Reported Event|Prevnar 13 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Prevnar 13™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of Prevnar 13™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Prevnar 13™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840078|NCT01262872|E5|Reported Event|Synflorix 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of Synflorix™ and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the Synflorix™, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. Synflorix™ was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840079|NCT01262872|E4|Reported Event|10PP-HD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, HD formulation, co-administered with the Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840080|NCT01262872|E3|Reported Event|10PP-LD 3+0d Group|This group consisted in infants aged 8-10 weeks at first vaccination enrolled as part the Cohort 2/Step 2 of the study who received 3 doses of the GSK 2189242A (or 10PP) vaccine in its low-dose (LD) formulation and EPI vaccines according to a 3+0 Schedule. That is, subjects received 3 doses of the 10PP vaccine, LD formulation, co-administered with Tritanrix™-HepB/Hib and Polio Sabin™ at 2-3-4 months of age (Day 0, Month 1 and Month 2), followed by one dose of each of the M-Vac™, Stamaril™ and Polio Sabin™ vaccines administered at approximately 9 months of age. The 10PP vaccine was administered intramuscularly into the right thigh; Tritanrix™-HepB/Hib, M-Vac™ and Stamaril™ were administered intramuscularly into the left thigh; Polio Sabin™ was administered orally.
840172|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840082|NCT01262872|E1|Reported Event|10PP-HD 1d Group|This group consisted in children aged 2-4 years at vaccination enrolled as part of the Cohort 1/Step 1 of the study who received a single dose of the GSK 2189242A (or 10PP) vaccine in its high-dose (HD) formulation at Day 0. The 10PP vaccine was administered intramuscularly in the non-dominant deltoid.
840083|NCT01262846|B3|Baseline|Total|Total of all reporting groups
840084|NCT01262846|B2|Baseline|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.~Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
840085|NCT01262846|B1|Baseline|Fluzone SD|"Fluzone® Standard dose~Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
840086|NCT01262846|P2|Participant Flow|Fluzone® High Dose|"Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject’s deltoid muscles.~Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
840087|NCT01262846|P1|Participant Flow|Fluzone SD|"Fluzone® Standard dose~Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles."
840088|NCT01262846|O2|Outcome|HD Recipients|Fluzone High Dose
840089|NCT01262846|O1|Outcome|SD Recipients|Fluzone Regular Dose
840090|NCT01262846|E2|Reported Event|HD Recipients|
840091|NCT01262846|E1|Reported Event|SD Recipients|
840092|NCT01262820|B1|Baseline|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
840093|NCT01262820|P1|Participant Flow|Single Intervention|"Subjects will take Pazopanib, 800 mg daily by mouth throughout the time in study~Pazopanib: Pazopanib, 800 mg by mouth daily each 21 day cycle"
840100|NCT01262755|P1|Participant Flow|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
840101|NCT01262755|O1|Outcome|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
840102|NCT01262755|E1|Reported Event|African Americans|"Consists of 450 African Americans living in the zip code surrounding Temple Hospital between the ages of 18 and 80.~Structured Interview: Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured."
840103|NCT01262599|B3|Baseline|Total|Total of all reporting groups
840104|NCT01262599|B2|Baseline|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
840105|NCT01262599|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
840106|NCT01262599|P2|Participant Flow|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
840107|NCT01262599|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
840108|NCT01262599|O2|Outcome|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
840109|NCT01262599|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
840141|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840110|NCT01262599|E2|Reported Event|PEMF Device|"Ivivi Torino II PEMF Device: The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours."
840111|NCT01262599|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
840112|NCT01262573|B3|Baseline|Total|Total of all reporting groups
840113|NCT01262573|B2|Baseline|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840114|NCT01262573|B1|Baseline|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840115|NCT01262573|P2|Participant Flow|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840116|NCT01262573|P1|Participant Flow|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840117|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840118|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840119|NCT01262573|O2|Outcome|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840120|NCT01262573|O1|Outcome|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840121|NCT01262573|E2|Reported Event|Smooth|"Vaginal cuff closure with smooth suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840122|NCT01262573|E1|Reported Event|Barbed|"Vaginal cuff closure with barbed suture~Closure of vaginal cuff: Closure of the vaginal cuff"
840123|NCT01262547|B1|Baseline|All Study Participants|"Dermabrasion-Micrografting, Dermabrasion and Control~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline.~Control: Untreated depigmented area"
840124|NCT01262547|P1|Participant Flow|Patients With Vitiligo|Three subjects with vitiligo were recruited for the study. All subjects had three test sites that were studied. One site received dermabrasion and micrografting, one site received dermabrasion alone and one site was not treated and served as the control.
840125|NCT01262547|O3|Outcome|Control|Control
840126|NCT01262547|O2|Outcome|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
840127|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
840130|NCT01262547|O1|Outcome|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
840131|NCT01262547|E3|Reported Event|Control|"Control~Depigmented areas that did not receive any treatment."
840132|NCT01262547|E2|Reported Event|Dermabrasion Alone|"Dermabrasion alone~Dermabrasion: Only dermabrasion (removal of epidermis) alone will be done at baseline."
840133|NCT01262547|E1|Reported Event|Dermabrasion-Micrografting|"Dermabrasion-Micrografting~Dermabrasion-Micrografting: Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis)."
840134|NCT01262456|B4|Baseline|Total|Total of all reporting groups
840135|NCT01262456|B3|Baseline|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840136|NCT01262456|B2|Baseline|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840137|NCT01262456|B1|Baseline|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840138|NCT01262456|P3|Participant Flow|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
840139|NCT01262456|P2|Participant Flow|50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
840140|NCT01262456|P1|Participant Flow|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for the 1-month open-label extension period.
840169|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840142|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840143|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840144|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840145|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840146|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840147|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840148|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840149|NCT01262456|O1|Outcome|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840150|NCT01262456|O3|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840151|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840152|NCT01262456|O1|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840153|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840154|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840156|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840157|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840158|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840159|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840160|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840161|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840162|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840163|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840164|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840165|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840166|NCT01262456|O2|Outcome|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840167|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840168|NCT01262456|O3|Outcome|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840173|NCT01262456|O1|Outcome|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840174|NCT01262456|E6|Reported Event|Placebo Double-Blind / Desmopressin 100 μg Open-Label|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840175|NCT01262456|E5|Reported Event|Desmopressin 75 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840176|NCT01262456|E4|Reported Event|Desmopressin 50 μg Double-Blind / 100 μg Open-Label|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period. Participants were switched to desmopressin 100 μg for 1-month open-label extension period.
840177|NCT01262456|E3|Reported Event|Placebo Double-Blind|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840178|NCT01262456|E2|Reported Event|Desmopressin 75 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 75 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840179|NCT01262456|E1|Reported Event|Desmopressin 50 μg Double-Blind|Participants took 1 orally disintegrating tablet of desmopressin 50 μg every night approximately 1 hour prior to bedtime for the entire duration of the 3-month double-blind treatment period.
840180|NCT01262352|B3|Baseline|Total|Total of all reporting groups
840181|NCT01262352|B2|Baseline|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
840182|NCT01262352|B1|Baseline|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
840183|NCT01262352|P2|Participant Flow|Placebo Then Ivacaftor|Placebo administered in Treatment Period 1 and ivacaftor administered in Treatment Period 2.
840184|NCT01262352|P1|Participant Flow|Ivacaftor Then Placebo|Ivacaftor administered in Treatment Period 1 and placebo administered in Treatment Period 2.
840185|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
840186|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
840187|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
840188|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
840189|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
840190|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
840191|NCT01262352|O2|Outcome|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
840192|NCT01262352|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
840193|NCT01262352|E2|Reported Event|Ivacaftor|Oral tablet of 150 mg of ivacaftor q12h for up to 28 days.
840194|NCT01262352|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 28 days.
840195|NCT01262339|B1|Baseline|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
840196|NCT01262339|P1|Participant Flow|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
840197|NCT01262339|O1|Outcome|Active Comparator: Comparator of Hand A Intervention vs Hand B|Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.
840198|NCT01262339|E1|Reported Event|Comparator of Hand A Intervention vs Hand B|"Hand A will receive 100U of BTX-A injected intradermally (SOC) Hand B will receive 100U delivered via iontophoresis.~BTX-A: 100 units of BTX-A will be delivered subject’s hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand"
840199|NCT01262287|B3|Baseline|Total|Total of all reporting groups
840200|NCT01262287|B2|Baseline|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
840201|NCT01262287|B1|Baseline|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
840202|NCT01262287|P2|Participant Flow|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
840203|NCT01262287|P1|Participant Flow|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
840204|NCT01262287|O4|Outcome|AKR1C3*2 G-carriers + Placebo|AKR1C3*2 G-carriers in placebo arm
840205|NCT01262287|O3|Outcome|AKR1C3*2 G-carriers + Dutasteride|AKR1C3*2 G-carriers in dutasteride arm (1 mg/day x 8 wks)
840206|NCT01262287|O2|Outcome|AKR1C3*2 C/C Genotype + Placebo|"AKR1C3*2 C/C genotype subjects in placebo arm~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
840207|NCT01262287|O1|Outcome|AKR1C3*2 C/C Genotype + Dutasteride|AKR1C3*2 C/C genotype subjects in dutasteride arm (1 mg daily for 8 wks)
840208|NCT01262287|O2|Outcome|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
840209|NCT01262287|O1|Outcome|Dutasteride|"dutasteride (1 mg oral daily dose) for 8-week treatment period~Dutasteride: dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period"
840210|NCT01262287|E2|Reported Event|Placebo|"placebo daily for 8-week treatment period~placebo: placebo capsules in same number as active drug, daily for 8-week treatment period"
840226|NCT01262118|B2|Baseline|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840227|NCT01262118|B1|Baseline|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840228|NCT01262118|P2|Participant Flow|Healthy Volunteers Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840229|NCT01262118|P1|Participant Flow|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840230|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840231|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840232|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840233|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840234|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840235|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840236|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840237|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840238|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840239|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840240|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840241|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840242|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840708|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
840243|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840244|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840245|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840246|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840247|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840248|NCT01262118|O2|Outcome|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840249|NCT01262118|O1|Outcome|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840250|NCT01262118|E2|Reported Event|Healthy Volunteer Cohort|Healthy volunteers with similar baseline demographic characteristics as the active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days.
840251|NCT01262118|E1|Reported Event|Rheumatoid Arthritis Cohort|Active rheumatoid arthritis participants were assessed for baseline cholesterol flux kinetics for 3 days and then received CP-690,550 10 mg tablet orally twice daily for 6 weeks.
840252|NCT01262105|B3|Baseline|Total|Total of all reporting groups
840253|NCT01262105|B2|Baseline|Device Deployed|
840254|NCT01262105|B1|Baseline|No Device|
840255|NCT01262105|P2|Participant Flow|Device Deployed|
840256|NCT01262105|P1|Participant Flow|No Device|
840257|NCT01262105|O2|Outcome|Device Deployed|The ABS device is employed during surgery.
840258|NCT01262105|O1|Outcome|No Device|No device is deployed during surgery
840259|NCT01262105|E2|Reported Event|Device Deployed|
840260|NCT01262105|E1|Reported Event|No Device|
840261|NCT01262092|B3|Baseline|Total|Total of all reporting groups
840262|NCT01262092|B2|Baseline|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
840265|NCT01262092|P1|Participant Flow|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
840266|NCT01262092|O2|Outcome|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
840267|NCT01262092|O1|Outcome|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
840268|NCT01262092|E2|Reported Event|Placebo|Buprenorphine will be given, with 2 capsules of placebo in the morning and 2 take-home capsules of placebo in the evening
840269|NCT01262092|E1|Reported Event|Gabapentin|Buprenorphine will be given along with 2 capsules of gabapentin in the morning and 2 take-home capsules of gabapentin for night.
840270|NCT01262027|B1|Baseline|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
840271|NCT01262027|P1|Participant Flow|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
840272|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
840273|NCT01262027|O1|Outcome|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
840274|NCT01262027|E1|Reported Event|Dovitinib|Dovitinib 500 mg single oral dose for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
840275|NCT01261975|B1|Baseline|Cataract Surgery|Cataract surgery with phacoemulsification using the Stellaris Vision Enhancement System
840276|NCT01261975|P1|Participant Flow|Cataract Surgery|Cataract surgery with phacoemulsification. Eligible patients were randomized to undergo cataract surgery using the 1.8 mm coaxial micro incision technique in either the right eye or the left eye. The fellow eye was assigned to undergo cataract surgery using the 2.75 mm standard incision. The Stellaris Vision Enhancement System was used for the surgery.
840277|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840278|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
840279|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840280|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
840281|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840282|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
840283|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840284|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
846781|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
840285|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840286|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
840287|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840288|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
840289|NCT01261975|O2|Outcome|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840290|NCT01261975|O1|Outcome|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System
840291|NCT01261975|E3|Reported Event|Cataract Surgery All Participants|Events by participant one eye with 1.8 mm coaxial micro-incision cataract surgery (C-MICS) and the contralateral eye with the 2.75 mm coaxial standard cataract surgery.
840292|NCT01261975|E2|Reported Event|Coaxial Small-Incision Cataract Surgery|2.75 mm coaxial standard cataract surgical procedure with phacoemulsification using the Stellaris Vision Enhancement System.
840293|NCT01261975|E1|Reported Event|Co-Axial Micro-Incision Cataract Surgery|1.8 mm coaxial micro-incision cataract surgery (C-MICS) with phacoemulsification using the Stellaris Vision Enhancement System.
840294|NCT01261624|B3|Baseline|Total|Total of all reporting groups
840295|NCT01261624|B2|Baseline|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patient received the dose of 0.75 mg/kg for 12 weeks in fed condition
840296|NCT01261624|B1|Baseline|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg BID|Patient received the dose of 0.50 mg/kg for 12 weeks in fed condition
840297|NCT01261624|P2|Participant Flow|High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID|Patients received the dose of 0.75 mg/kg BID for 12 weeks in fed conditions
840298|NCT01261624|P1|Participant Flow|Low Dose Treatment Cohort (LDTC): 0.50 mg/kg Twice Daily (BID)|Patients (pts) received the dose of 0.50 mg/kg BID for 12 weeks in fed condition
840299|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
840323|NCT01261559|E2|Reported Event|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
840300|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
840301|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
840302|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
840303|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
840304|NCT01261624|O5|Outcome|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
840305|NCT01261624|O4|Outcome|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
840306|NCT01261624|O3|Outcome|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
840307|NCT01261624|O2|Outcome|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
840308|NCT01261624|O1|Outcome|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
840309|NCT01261624|E5|Reported Event|High Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
840310|NCT01261624|E4|Reported Event|High Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
840311|NCT01261624|E3|Reported Event|Switched Dose|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator’s decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort). Safety data selected for high and low dose in this cohort are not available, this kind of analysis has not been performed.
840312|NCT01261624|E2|Reported Event|Low Dose Throughout|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
840313|NCT01261624|E1|Reported Event|Low Dose Discontinued|The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
840314|NCT01261559|B3|Baseline|Total|Total of all reporting groups
840315|NCT01261559|B2|Baseline|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
840316|NCT01261559|B1|Baseline|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
840317|NCT01261559|P2|Participant Flow|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
840318|NCT01261559|P1|Participant Flow|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
840319|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
840320|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
840321|NCT01261559|O2|Outcome|Chrysalis CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
840322|NCT01261559|O1|Outcome|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
840324|NCT01261559|E1|Reported Event|Standard CT|Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
840325|NCT01261507|B1|Baseline|Radiologists|Board Certified Radiologists working in the Washington, DC, Baltimore region
840326|NCT01261507|P1|Participant Flow|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
840327|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
840328|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
840329|NCT01261507|O2|Outcome|Radiologists Working With Software|radiologists interpret the images using the experimental software
840330|NCT01261507|O1|Outcome|Radiologists Working Without Software|Radiologists interpret the same images without the use of software
840331|NCT01261507|O2|Outcome|Radiologists Working With Software|Each radiologist serves as own control, working without and with software. This is the arm working with software
840332|NCT01261507|O1|Outcome|Board Certified Radiologists Working Without Software|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
840333|NCT01261507|E1|Reported Event|Board Certified Radiologists|15 Board Certified radiologists were recruited from non-University sites. Each served as subject and control is a crossover design
840334|NCT01261390|B5|Baseline|Total|Total of all reporting groups
840335|NCT01261390|B4|Baseline|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840336|NCT01261390|B3|Baseline|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840337|NCT01261390|B2|Baseline|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840381|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840338|NCT01261390|B1|Baseline|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840339|NCT01261390|P4|Participant Flow|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840340|NCT01261390|P3|Participant Flow|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840341|NCT01261390|P2|Participant Flow|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840342|NCT01261390|P1|Participant Flow|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840561|NCT01260922|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
840562|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
840343|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840344|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840345|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840346|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840347|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840559|NCT01260922|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
841955|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
840348|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840349|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840350|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840351|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840352|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840353|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840365|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840622|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Central|stereo-specific ketorolac analysis by NONMEM
840354|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840355|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840356|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840357|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840392|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840358|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840359|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840360|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840361|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840362|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840363|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840364|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840563|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
843340|NCT01253980|O2|Outcome|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
840366|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840367|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840368|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840369|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840370|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840371|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840372|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840373|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840374|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840375|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840376|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840564|NCT01260922|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
843341|NCT01253980|O1|Outcome|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
840377|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840378|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840379|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840380|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840382|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840383|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840384|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840385|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840386|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840387|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840565|NCT01260922|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
840566|NCT01260922|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
840388|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840389|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840390|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840391|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840393|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840394|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840395|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840396|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840397|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840398|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840421|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840399|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840400|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840401|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840402|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840403|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840560|NCT01260922|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
840709|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
840404|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840405|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840406|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840407|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840408|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840409|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840433|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840617|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840410|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840411|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840412|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840413|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840449|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840706|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
840414|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840415|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840416|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840417|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840418|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840419|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840420|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840422|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840423|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840424|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840425|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840552|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
846782|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
840426|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840427|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840428|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840429|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840430|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840431|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840432|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840434|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840435|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840436|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840437|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840553|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
846783|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
840438|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840439|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840440|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840441|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840442|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840443|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840444|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840445|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840446|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840447|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840448|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840554|NCT01260948|O1|Outcome|Donepezil Hydrochloride (Test)|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in either period.
846784|NCT01243242|O1|Outcome|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
840450|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840451|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840452|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840453|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840454|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840455|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840456|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840457|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840458|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840459|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840460|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840555|NCT01260948|E2|Reported Event|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
840461|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840462|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840463|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840464|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840465|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840466|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840467|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840468|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840469|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840470|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840471|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840556|NCT01260948|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
840557|NCT01260922|B3|Baseline|Total|Total of all reporting groups
840472|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840473|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840474|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840475|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840476|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840477|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840618|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840478|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840479|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840480|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840481|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840482|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840558|NCT01260922|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
840483|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840484|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840485|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840486|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840487|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
840488|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
840489|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
840490|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
840491|NCT01261390|O4|Outcome|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840492|NCT01261390|O3|Outcome|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual apnea hypopnea index (AHI) to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840493|NCT01261390|O2|Outcome|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840494|NCT01261390|O1|Outcome|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840495|NCT01261390|O2|Outcome|Active PAP With Motivational Enhancement|Participants randomly assigned to Active PAP with Behavioral Modification arm (Active+Beh).
840496|NCT01261390|O1|Outcome|Active PAP With RT Support Only|Participants randomly assigned to either the Active PAP with RT Support arm (ActiveBeh).
840497|NCT01261390|O2|Outcome|Active Treatment Arms (Pooled)|Participants randomly assigned to either the Active-PAP + Respiratory Therapist (RT) Support or the Active-PAP + Behavioral Modification Therapy arm.
840498|NCT01261390|O1|Outcome|Control Arms (Pooled)|Participants randomly assigned to either the Conservative Medical Treatment (CMT) or Sham-PAP arms.
840499|NCT01261390|E4|Reported Event|Active PAP With Behavioral Modification (Active+Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The PAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
840707|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
840500|NCT01261390|E3|Reported Event|Active PAP With RT Support (Active-Beh)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
840501|NCT01261390|E2|Reported Event|Sham PAP (Sham)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
840502|NCT01261390|E1|Reported Event|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
840540|NCT01261052|B1|Baseline|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
840541|NCT01261052|P1|Participant Flow|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
840542|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
840543|NCT01261052|O1|Outcome|All Study Participants|Type 1 Diabetes Mellitus subjects who fit the inclusion/exclusion criteria will undergo artificial pancreas closed-loop study for 33 hours. For one intervention for the first 13 hours, the original artificial pancreas algorithm FMPD, will be used to control the subject's blood glucose. After 13 hours, the adaptive component or APD will be used to control the subject's blood glucose for the remaining 20 hours. For the other intervention study, the adaptive component or APD will be used to control the subject's blood glucose for the entire 33 hours.
840544|NCT01261052|E2|Reported Event|FMPD/APD Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
840545|NCT01261052|E1|Reported Event|APD Only Intervention|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
840546|NCT01260948|B3|Baseline|Total|Total of all reporting groups
840547|NCT01260948|B2|Baseline|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
840548|NCT01260948|B1|Baseline|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
840549|NCT01260948|P2|Participant Flow|Aricept® (Reference) First|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in first period followed by 10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in the second period.
840550|NCT01260948|P1|Participant Flow|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
840551|NCT01260948|O2|Outcome|Aricept® (Reference)|10 mg Aricept® Orally Disintegrating Tablets reference product dosed in either period.
840567|NCT01260922|E1|Reported Event|Donepezil Hydrochloride (Test) First|10 mg Donepezil Hydrochloride Orally Disintegrating Tablets test product dosed in first period followed by 10 mg Aricept® Orally Disintegrating Tablets reference product dosed in the second period.
840568|NCT01260896|B3|Baseline|Total|Total of all reporting groups
840569|NCT01260896|B2|Baseline|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
840570|NCT01260896|B1|Baseline|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
840571|NCT01260896|P2|Participant Flow|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
840572|NCT01260896|P1|Participant Flow|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
840573|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
840574|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
840575|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
840576|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
840577|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
840578|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
840579|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
840580|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
840581|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
840582|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
840583|NCT01260896|O2|Outcome|Effexor® XR (Reference)|150 mg Effexor® XR Capsules reference product dosed in either period.
840584|NCT01260896|O1|Outcome|Venlafaxine Hydrochloride (Test)|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in either period.
840585|NCT01260896|E2|Reported Event|Effexor® XR (Reference) First|150 mg Effexor® XR Capsules reference product dosed in first period followed by 150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in the second period.
840586|NCT01260896|E1|Reported Event|Venlafaxine Hydrochloride (Test) First|150 mg Venlafaxine Hydrochloride Extended-Release Capsules test product dosed in first period followed by 150 mg Effexor® XR Capsules reference product dosed in the second period.
840587|NCT01260883|B4|Baseline|Total|Total of all reporting groups
840588|NCT01260883|B3|Baseline|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
840589|NCT01260883|B2|Baseline|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
840590|NCT01260883|B1|Baseline|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
840591|NCT01260883|P3|Participant Flow|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
840592|NCT01260883|P2|Participant Flow|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
840593|NCT01260883|P1|Participant Flow|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
840594|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
840595|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac after surgery
840596|NCT01260883|O2|Outcome|Placebo Infusion|infants receiving placebo infusion after surgery
840597|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving ketorolac infusion after surgery
840598|NCT01260883|O3|Outcome|Placebo|noncompartmental analysis of stereo-isomers of ketorolac
840599|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|noncompartmental analysis of stereo-isomers of ketorolac
840600|NCT01260883|O1|Outcome|S- Ketorolac Half-life|noncompartmental ketorolac analysis
840601|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840602|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840603|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution, Peripheral|stereo-specific ketorolac analysis by NONMEM
840604|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840605|NCT01260883|O2|Outcome|R+ Ketorolac Volume Distribution Central|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840606|NCT01260883|O1|Outcome|S- Ketorolac Volume Distribution Central|stereo-specific ketorolac analysis by NONMEM
840607|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840608|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840609|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac analysis by NONMEM
840610|NCT01260883|O2|Outcome|Placebo|infants given placebo intravenously after surgery
840611|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants given ketorolac intravenously after surgery
840612|NCT01260883|O2|Outcome|Placebo|infants receiving placebo infusion intravenously after surgery
840613|NCT01260883|O1|Outcome|Ketorolac 1 or 0.5 mg/kg|infants receiving active drug intravenously after surgery
840614|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840615|NCT01260883|O2|Outcome|R+ Ketorolac Half-life|stereo-specific ketorolac analyzed by population kinetic (NONMEM)
840616|NCT01260883|O1|Outcome|S- Ketorolac Half-life|stereo-specific ketorolac analysis by NONMEM
840623|NCT01260883|O3|Outcome|Placebo|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
840624|NCT01260883|O2|Outcome|R+ Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration,analyzed by population pharmacokinetic analysis (NONMEM)
840625|NCT01260883|O1|Outcome|S- Ketorolac Clearance|stereo-specific ketorolac isomer concentrations from blood samples collected for 12 hours after ketorolac intravenous administration, analyzed by NONMEM population pharmacokinetic methodology
840626|NCT01260883|E3|Reported Event|Dextrose 5% in Water (D5W)|intravenous infusion over 10 minutes
840627|NCT01260883|E2|Reported Event|Ketorolac 0.5 mg/kg Intravenous|intravenous infusion over 10 minutes
840628|NCT01260883|E1|Reported Event|Ketorolac 1 mg/kg Intravenous|intravenous infusion over 10 minutes
840629|NCT01260701|B1|Baseline|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840630|NCT01260701|P1|Participant Flow|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840631|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840632|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840633|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840634|NCT01260701|O1|Outcome|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840635|NCT01260701|E1|Reported Event|MK-2206|Patients receive Akt inhibitor MK-2206 PO QD, every other day, for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840636|NCT01260688|B3|Baseline|Total|Total of all reporting groups
840637|NCT01260688|B2|Baseline|Arm II|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840638|NCT01260688|B1|Baseline|Arm I|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840639|NCT01260688|P2|Participant Flow|Arm II|Patients receive cediranib maleate as in arm I. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840640|NCT01260688|P1|Participant Flow|Arm I|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840641|NCT01260688|O2|Outcome|Arm II - Cediranib Alone|Patients receive oral cediranib maleate once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840642|NCT01260688|O1|Outcome|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
840643|NCT01260688|E2|Reported Event|Arm II - Cediranib Alone|
840644|NCT01260688|E1|Reported Event|Arm I - Cediranib Plus Dasatinib|Patients receive oral cediranib maleate once daily and oral dasatinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
840645|NCT01260662|B4|Baseline|Total|Total of all reporting groups
840646|NCT01260662|B3|Baseline|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840647|NCT01260662|B2|Baseline|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840648|NCT01260662|B1|Baseline|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840649|NCT01260662|P3|Participant Flow|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840650|NCT01260662|P2|Participant Flow|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840651|NCT01260662|P1|Participant Flow|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840652|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840653|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840654|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840704|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
843342|NCT01253980|E2|Reported Event|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
840655|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840656|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840657|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840658|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840659|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840660|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840661|NCT01260662|O3|Outcome|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840662|NCT01260662|O2|Outcome|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840663|NCT01260662|O1|Outcome|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840664|NCT01260662|E3|Reported Event|4:1 Propofol/Ketamine|"Deep sedation using 4:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 4:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840665|NCT01260662|E2|Reported Event|1:1 Propofol/Ketamine|"Deep sedation using 1:1 propofol to ketamine mixture (prepared with propofol 10 mg/mL and ketamine 10mg/mL)~Subjects received a 1 mg/kg IV bolus of 1:1 propofol/ketamine mixture followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840666|NCT01260662|E1|Reported Event|Propofol|"Deep sedation using propofol (10 mg /mL)~Subjects received a 1 mg/kg IV bolus of propofol followed by 0.5 mg/kg every 3 to 5 minutes as needed to achieve and maintain adequate sedation"
840667|NCT01260649|B3|Baseline|Total|Total of all reporting groups
840668|NCT01260649|B2|Baseline|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840669|NCT01260649|B1|Baseline|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840670|NCT01260649|P2|Participant Flow|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840671|NCT01260649|P1|Participant Flow|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840672|NCT01260649|O2|Outcome|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840673|NCT01260649|O1|Outcome|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840674|NCT01260649|O2|Outcome|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840675|NCT01260649|O1|Outcome|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840705|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
843343|NCT01253980|E1|Reported Event|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
840676|NCT01260649|E2|Reported Event|Placebo|"IV saline, followed by anesthestic agent titrated to sedation and succinylcholine titrated to muscle relaxation.~Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840677|NCT01260649|E1|Reported Event|Ketamine|"ketamine (0.5 mg/kg) followed by anesthetic agent titrated to sedation and succinylcholine titrated to muscle relaxation Right unilateral ECT at 5-6x seizure threshold three times a week~ketamine: eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg), followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care"
840678|NCT01260584|B5|Baseline|Total|Total of all reporting groups
840679|NCT01260584|B4|Baseline|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840680|NCT01260584|B3|Baseline|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840681|NCT01260584|B2|Baseline|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840682|NCT01260584|B1|Baseline|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840683|NCT01260584|P4|Participant Flow|Prasugrel Then Clopidogrel Non-Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840684|NCT01260584|P3|Participant Flow|Prasugrel Then Clopidogrel Smokers|"Prasugrel 10 mg film-coated tablet daily dose × 10 days. To maintain blinding, placebo film-coated tablets matching clopidogrel in appearance will be given daily × 10 days to subjects in the prasugrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Clopidogrel : One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840685|NCT01260584|P2|Participant Flow|Clopidogrel Then Prasugrel Non-Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840686|NCT01260584|P1|Participant Flow|Clopidogrel Then Prasugrel Smokers|"Clopidogrel 75 mg film-coated tablet daily dose x 10 days To maintain blinding, placebo film-coated tablets matching prasugrel in appearance will be given daily × 10 days to subjects in the clopidogrel treatment group. In addition, aspirin 81 mg to 325 mg daily will be taken.~Prasugrel : One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken."
840687|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
840688|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
840689|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
840690|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
840691|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
840692|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
840693|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
840694|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
840695|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
840696|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
840697|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
840698|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
840699|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
840700|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
840701|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
840702|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
840703|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
840711|NCT01260584|O4|Outcome|Clopidogrel Non-Smokers|participants who do not currently smoke while receiving clopidogrel as test medication during study
840712|NCT01260584|O3|Outcome|Clopidogrel Smokers|participants who currently smoke while receiving clopidogrel as test medication during study
840713|NCT01260584|O2|Outcome|Prasugrel Non-Smokers|participants who do not currently smoke while receiving prasugrel as test medication during study
840714|NCT01260584|O1|Outcome|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
840715|NCT01260584|E4|Reported Event|Clopidogrel Non-Smokers|"participants who do not currently smoke while receiving clopidogrel as test medication during study. 1 participant who started this arm was not at risk."
840716|NCT01260584|E3|Reported Event|Clopidogrel Smokers|"participants who currently smoke while receiving clopidogrel as test medication during study. 2 participants who started this arm were not At risk."
840717|NCT01260584|E2|Reported Event|Prasugrel Non-Smokers|"participants who do not currently smoke while receiving prasugrel as test medication during study. 1 participant who started the arm was not at risk."
840718|NCT01260584|E1|Reported Event|Prasugrel Smokers|participants who currently smoke while receiving prasugrel as test medication during study
840719|NCT01260493|B3|Baseline|Total|Total of all reporting groups
840720|NCT01260493|B2|Baseline|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
840721|NCT01260493|B1|Baseline|Conventional Care, Controlgroup|conventional care, control group
840722|NCT01260493|P2|Participant Flow|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
840723|NCT01260493|P1|Participant Flow|Conventional Care, Controlgroup|conventional care, control group
840724|NCT01260493|O2|Outcome|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
840725|NCT01260493|O1|Outcome|Conventional Care, Controlgroup|conventional care, control group
840726|NCT01260493|E2|Reported Event|Integrated Health Care Chain|"integrated health care chain. Geriatric assessment at emergency department (ED), case manager with multiprofessional team in the community, support for informal caregivers~integrated health care chain : Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers"
840727|NCT01260493|E1|Reported Event|Conventional Care, Controlgroup|conventional care, control group
840728|NCT01260467|B1|Baseline|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
840729|NCT01260467|P1|Participant Flow|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
840730|NCT01260467|O1|Outcome|Single Arm|No adverse events reported.
840731|NCT01260467|O1|Outcome|Memantine Arm|memantine: 10 milligrams orally twice a day
840732|NCT01260467|O1|Outcome|Single Agent Memantine Group|memantine:10 milligrams orally twice a day
840733|NCT01260467|E1|Reported Event|Single Agent Memantine Group|NO data to report
840734|NCT01260454|B1|Baseline|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
840735|NCT01260454|P1|Participant Flow|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
840736|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
840737|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
840738|NCT01260454|O1|Outcome|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
840767|NCT01260350|P16|Participant Flow|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg fixed-dose combination (FDC) once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840739|NCT01260454|E1|Reported Event|Qutenza Patch|"We will place a Qutenza patch following the package insert (60 minute application following topical anesthetic) onto an area of healthy skin. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.~Qutenza (8% capsaicin): We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes"
840740|NCT01260350|B21|Baseline|Total|Total of all reporting groups
840741|NCT01260350|B20|Baseline|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840742|NCT01260350|B19|Baseline|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840743|NCT01260350|B18|Baseline|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840744|NCT01260350|B17|Baseline|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840745|NCT01260350|B16|Baseline|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840746|NCT01260350|B15|Baseline|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840747|NCT01260350|B14|Baseline|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840748|NCT01260350|B13|Baseline|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840749|NCT01260350|B12|Baseline|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840750|NCT01260350|B11|Baseline|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840751|NCT01260350|B10|Baseline|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840752|NCT01260350|B9|Baseline|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840753|NCT01260350|B8|Baseline|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840754|NCT01260350|B7|Baseline|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840755|NCT01260350|B6|Baseline|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840756|NCT01260350|B5|Baseline|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840757|NCT01260350|B4|Baseline|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840758|NCT01260350|B3|Baseline|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840759|NCT01260350|B2|Baseline|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840760|NCT01260350|B1|Baseline|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840761|NCT01260350|P22|Participant Flow|Group 22: LDV/SOF FDC 6 wk: GT 1, TN|Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
840762|NCT01260350|P21|Participant Flow|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840763|NCT01260350|P20|Participant Flow|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840764|NCT01260350|P19|Participant Flow|Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840765|NCT01260350|P18|Participant Flow|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840766|NCT01260350|P17|Participant Flow|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840824|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840768|NCT01260350|P15|Participant Flow|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840769|NCT01260350|P14|Participant Flow|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840798|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840770|NCT01260350|P13|Participant Flow|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840771|NCT01260350|P12|Participant Flow|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus ledipasvir (LDV) 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840772|NCT01260350|P11|Participant Flow|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840773|NCT01260350|P10|Participant Flow|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840774|NCT01260350|P9|Participant Flow|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840775|NCT01260350|P8|Participant Flow|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840776|NCT01260350|P7|Participant Flow|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840777|NCT01260350|P6|Participant Flow|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840778|NCT01260350|P5|Participant Flow|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840779|NCT01260350|P4|Participant Flow|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840780|NCT01260350|P3|Participant Flow|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840781|NCT01260350|P2|Participant Flow|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840782|NCT01260350|P1|Participant Flow|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|Sofosbuvir (SOF) 400 mg once daily plus weight-based ribavirin (RBV) (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840783|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840784|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840785|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840786|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840787|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840788|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840789|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840790|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840791|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840792|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840793|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840794|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840795|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840796|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840797|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840799|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840800|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840801|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840802|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840803|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840804|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840805|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840806|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840807|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840808|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840809|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840810|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840811|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840812|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840813|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840814|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840815|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840816|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840817|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840818|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840819|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840820|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840821|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840822|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840823|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
843344|NCT01253902|B4|Baseline|Total|Total of all reporting groups
840825|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840826|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840827|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840828|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840829|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840830|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840831|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840832|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840833|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840834|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840835|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840836|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840837|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840838|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840839|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840840|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840841|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840842|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840843|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840844|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840845|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840846|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840847|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840848|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840849|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840850|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840851|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840852|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840853|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840854|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840855|NCT01260350|O17|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840856|NCT01260350|O16|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840857|NCT01260350|O15|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840858|NCT01260350|O14|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840859|NCT01260350|O13|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840860|NCT01260350|O12|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840861|NCT01260350|O11|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840862|NCT01260350|O10|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840863|NCT01260350|O9|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840864|NCT01260350|O8|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840865|NCT01260350|O7|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840866|NCT01260350|O6|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840867|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840868|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840869|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840870|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840871|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840872|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840873|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840874|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840875|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840876|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840877|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840878|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840879|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840880|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840881|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
844264|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
840882|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840883|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840912|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840884|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840885|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840886|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840887|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840888|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840889|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840890|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840891|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840892|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840893|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840894|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840895|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840896|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840897|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840898|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840899|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840900|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840901|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840902|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840903|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840904|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840905|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840906|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840907|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840908|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840909|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840910|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840911|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840913|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840914|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840915|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840916|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840917|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840918|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840919|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840920|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840921|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840922|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840923|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840924|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840925|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840926|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840927|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840928|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840929|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840930|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840931|NCT01260350|O20|Outcome|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840932|NCT01260350|O19|Outcome|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840933|NCT01260350|O18|Outcome|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840934|NCT01260350|O17|Outcome|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840935|NCT01260350|O16|Outcome|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840936|NCT01260350|O15|Outcome|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840937|NCT01260350|O14|Outcome|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840938|NCT01260350|O13|Outcome|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
841888|NCT01258387|B8|Baseline|GGF2 Seventh Escalataed Dose|Seventh dosing: patients in cohort randomized to GGF2
840939|NCT01260350|O12|Outcome|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840940|NCT01260350|O11|Outcome|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
841793|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
840941|NCT01260350|O10|Outcome|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840942|NCT01260350|O9|Outcome|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840943|NCT01260350|O8|Outcome|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840944|NCT01260350|O7|Outcome|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840945|NCT01260350|O6|Outcome|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840946|NCT01260350|O5|Outcome|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840947|NCT01260350|O4|Outcome|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840948|NCT01260350|O3|Outcome|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840949|NCT01260350|O2|Outcome|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840950|NCT01260350|O1|Outcome|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840951|NCT01260350|E20|Reported Event|Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks in treatment-naive participants with genotype 1 HCV infection
840952|NCT01260350|E19|Reported Event|Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, Hemophiliac|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in hemophiliac participants with genotype 1 HCV infection
840953|NCT01260350|E18|Reported Event|Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840954|NCT01260350|E17|Reported Event|Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840955|NCT01260350|E16|Reported Event|Group 16: LDV/SOF FDC 12 wk: GT 1, Fibrosis|LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment
840956|NCT01260350|E15|Reported Event|Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840957|NCT01260350|E14|Reported Event|Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840958|NCT01260350|E13|Reported Event|Group 13: SOF+RBV+LDV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840959|NCT01260350|E12|Reported Event|Group 12: SOF+RBV+LDV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks in treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment
840960|NCT01260350|E11|Reported Event|Group 11: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840961|NCT01260350|E10|Reported Event|Group 10: SOF+RBV 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840962|NCT01260350|E9|Reported Event|Group 9: SOF+RBV 12 wk: GT 2 or 3, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced participants with genotype 2 or 3 HCV infection
840963|NCT01260350|E8|Reported Event|Group 8: SOF+RBV 12 wk: GT 1, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive participants with genotype 1 HCV infection
840964|NCT01260350|E7|Reported Event|Group 7: SOF+RBV 12 wk: GT 1, TE|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment
840965|NCT01260350|E6|Reported Event|Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840966|NCT01260350|E5|Reported Event|Group 5: SOF 12 wk: GT 2 or 3, TN|SOF 400 mg once daily for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
841392|NCT01256918|O2|Outcome|Phacodepth|depth of penetration of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
840967|NCT01260350|E4|Reported Event|Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840968|NCT01260350|E3|Reported Event|Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840969|NCT01260350|E2|Reported Event|Group 2: SOF+RBV 12 wk +PEG 4 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks in treatment-naive participants with genotype 2 or 3 HCV infection
840970|NCT01260350|E1|Reported Event|Group 1: SOF+RBV 12 wk: GT 2 or 3, TN|SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks in treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection
840971|NCT01260324|B3|Baseline|Total|Total of all reporting groups
840972|NCT01260324|B2|Baseline|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
840973|NCT01260324|B1|Baseline|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
840974|NCT01260324|P2|Participant Flow|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
840975|NCT01260324|P1|Participant Flow|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
840976|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
840977|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
840978|NCT01260324|O1|Outcome|NAION Cases|NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review. Data from definite and possible NAION cases identified from medical record review only contributed to the analysis.
840979|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
840980|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
840981|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
840982|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
840983|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
841026|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841393|NCT01256918|O1|Outcome|Lens Thickness|lens thickness as measured using an A scan biometer
840984|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
840985|NCT01260324|O1|Outcome|Combined NAION Cases and Controls|"NAION cases: from the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.~Controls: from the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)."
840986|NCT01260324|E2|Reported Event|Controls|From the study population, patients without a claim associated with an ischemic optic neuropathy diagnosis code were randomly selected as controls (n = 20,000)
840987|NCT01260324|E1|Reported Event|NAION Cases|Nonarteritic anterior ischemic optic neuropathy (NAION). From the study population, patients with a claim associated with an ischemic optic neuropathy diagnosis code were identified as potential NAION cases (n = 3,732). From the potential NAION cases, definite and possible NAION cases were identified using medical record review and a claims algorithm (n=1,283). Data from definite and possible NAION cases contributed to the analysis.
840988|NCT01260311|B1|Baseline|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840989|NCT01260311|P1|Participant Flow|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 milligram (mg) or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840990|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840991|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840992|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840993|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840994|NCT01260311|O1|Outcome|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840995|NCT01260311|E1|Reported Event|Fesoterodine Fumarate|Participants received fesoterodine fumarate (Toviaz) 4 mg or 8 mg orally once daily, with use and dosage adjusted according to medical and therapeutic necessity.
840996|NCT01260272|B3|Baseline|Total|Total of all reporting groups
840997|NCT01260272|B2|Baseline|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
840998|NCT01260272|B1|Baseline|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
840999|NCT01260272|P2|Participant Flow|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841000|NCT01260272|P1|Participant Flow|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841001|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841027|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841054|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841030|NCT01260194|E1|Reported Event|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841031|NCT01260142|B7|Baseline|Total|Total of all reporting groups
841891|NCT01258387|B5|Baseline|GGF2 Fourth Escalated Dose|Fourth dosing: patients in cohort randomized to GGF2
841002|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841003|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841004|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841005|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841006|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841007|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841008|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841009|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins: Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841010|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator: Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841011|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841028|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841029|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841120|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841012|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841013|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841014|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841015|NCT01260272|O2|Outcome|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841016|NCT01260272|O1|Outcome|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841017|NCT01260272|E2|Reported Event|Raisin Group|"This group will receive raisins to consume three times a day with meals~Raisins : Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium."
841018|NCT01260272|E1|Reported Event|Alternative Snack Group|"This group will receive 100 calorie alternative snack packs to consume three times a day with meals. Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables~Alternative Snack Comparator : Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers"
841019|NCT01260194|B1|Baseline|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841020|NCT01260194|P1|Participant Flow|Trastuzumab|Trastuzumab was administered at a loading dose of 8 milligram per kilogram (mg/kg) body weight on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841021|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841022|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841023|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841024|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841025|NCT01260194|O1|Outcome|Trastuzumab|Trastuzumab was administered at a loading dose of 8 mg/kg on Day 1, followed by 6 mg/kg intravenous infusion every 3 weeks plus standard chemotherapy as per Investigator’s discretion or as per institutional practice, until disease progression, early withdrawal due to unmanageable toxicity, or consent withdrawal.
841032|NCT01260142|B6|Baseline|Cohort 3 ( Sequence F)|Participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
841033|NCT01260142|B5|Baseline|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
841034|NCT01260142|B4|Baseline|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
841035|NCT01260142|B3|Baseline|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
841036|NCT01260142|B2|Baseline|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
841037|NCT01260142|B1|Baseline|Cohort 1 (Sequence A)|Participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
841038|NCT01260142|P6|Participant Flow|Cohort 3 (Sequence F)|Participants were administered an intravenous IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium.
841039|NCT01260142|P5|Participant Flow|Cohort 3 (Sequence E)|Participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.
841040|NCT01260142|P4|Participant Flow|Cohort 2 (Sequence D)|Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium.
841041|NCT01260142|P3|Participant Flow|Cohort 2 (Sequence C)|Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.
841042|NCT01260142|P2|Participant Flow|Cohort 1 (Sequence B)|Participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium.
841043|NCT01260142|P1|Participant Flow|Cohort 1 (Sequence A)|Participants were administered intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.
841044|NCT01260142|O3|Outcome|Cohort 3 (Fospropofol 15.0 : Propofol 1.5)|"Cohort 3 (Sequence E): participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.5 mg/kg propofol injectable emulsion.~Cohort (Sequence F): participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 15 mg/kg of fospropofol disodium."
841045|NCT01260142|O2|Outcome|Cohort 2 (Fospropofol 10.0 : Propofol 1.0)|"Cohort 2 (Sequence C): Participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 1.0 mg/kg propofol injectable emulsion.~Cohort 2 (Sequence D): Participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 10 mg/kg of fospropofol disodium."
841046|NCT01260142|O1|Outcome|Cohort 1 (Fospropofol 6.5 : Propofol 0.65)|"Cohort 1 (Sequence A): participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 0.65 mg/kg propofol injectable emulsion.~Cohort 1: Sequence B: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1, then after a 7-14 day washout began Treatment Period 2 with an IV bolus of 6.5 mg/kg of fospropofol disodium."
841047|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
841048|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841049|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
841050|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841051|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
841052|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841053|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
841121|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841055|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
841056|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841057|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
841058|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841059|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
841060|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841061|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
841062|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841063|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
841064|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841065|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841066|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841067|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841068|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
841069|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841070|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
841071|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841072|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
841073|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841074|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841075|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841076|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841077|NCT01260142|O6|Outcome|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
841078|NCT01260142|O5|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841079|NCT01260142|O4|Outcome|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
841080|NCT01260142|O3|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841081|NCT01260142|O2|Outcome|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
841082|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841083|NCT01260142|O3|Outcome|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841084|NCT01260142|O2|Outcome|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841085|NCT01260142|O1|Outcome|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an intravenous (IV) bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841086|NCT01260142|E6|Reported Event|Propofol 1.5 mg/kg|Cohort 3: participants were administered an IV bolus of 1.5 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group F) or Treatment Period 2 (Sequence Group E).
841154|NCT01259492|B5|Baseline|Total|Total of all reporting groups
841892|NCT01258387|B4|Baseline|GGF2 Third Escalated Dose|Third dosing: patients in cohort randomized to GGF2
841087|NCT01260142|E5|Reported Event|Fospropofol 15 mg/kg|Cohort 3: participants were administered an IV bolus of 15 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group E) or Treatment Period 2 (Sequence Group F).
841088|NCT01260142|E4|Reported Event|Propofol 1.0 mg/kg|Cohort 2: participants were administered an IV bolus of 1.0 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group D) or Treatment Period 2 (Sequence Group C).
841089|NCT01260142|E3|Reported Event|Fospropofol 10 mg/kg|Cohort 2: participants were administered an IV bolus of 10 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group C) or Treatment Period 2 (Sequence Group D).
841090|NCT01260142|E2|Reported Event|Propofol 0.65 mg/kg|Cohort 1: participants were administered an IV bolus of 0.65 mg/kg of propofol injectable emulsion during Treatment Period 1 (Sequence Group B) or Treatment Period 2 (Sequence Group A).
841091|NCT01260142|E1|Reported Event|Fospropofol 6.5 mg/kg|Cohort 1: participants were administered an IV bolus of 6.5 mg/kg of fospropofol disodium during Treatment Period 1 (Sequence Group A) or Treatment Period 2 (Sequence Group B).
841092|NCT01259726|B5|Baseline|Total|Total of all reporting groups
841093|NCT01259726|B4|Baseline|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841094|NCT01259726|B3|Baseline|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841095|NCT01259726|B2|Baseline|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841096|NCT01259726|B1|Baseline|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841097|NCT01259726|P4|Participant Flow|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841098|NCT01259726|P3|Participant Flow|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841099|NCT01259726|P2|Participant Flow|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841100|NCT01259726|P1|Participant Flow|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841101|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841102|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841103|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841104|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841105|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841106|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841107|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841108|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841109|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841110|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841111|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841112|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841113|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841114|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841115|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841116|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841117|NCT01259726|O4|Outcome|VP 20621 High Dose|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 14.
841118|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841119|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841122|NCT01259726|O3|Outcome|VP 20621 High Dose and Placebo|VP 20621 oral liquid containing 10^7 purified spores of NTCD-M3 once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841123|NCT01259726|O2|Outcome|VP 20621 Low Dose and Placebo|VP 20621 oral liquid containing 10^4 purified spores of non-toxigenic Clostridium difficile-strain M3 (NTCD-M3; the dormant form of a live organism) once daily from Day 1 to 7 followed by placebo matched to VP 20621 oral liquid once daily from Day 8 to 14.
841124|NCT01259726|O1|Outcome|Placebo|Placebo matched to VP 20621 oral liquid once daily from Day 1 to 14.
841125|NCT01259726|E4|Reported Event|VP20621 High Dose|VP20621: VP20621 as oral liquid once daily for 14 days
841126|NCT01259726|E3|Reported Event|VP20621 High Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
841127|NCT01259726|E2|Reported Event|VP20621 Low Dose and Placebo|VP20621: VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days Placebo: 10 mL placebo once daily for 14 days
841128|NCT01259726|E1|Reported Event|Placebo|Placebo: 10 mL placebo once daily for 14 days
841129|NCT01259713|B3|Baseline|Total|Total of all reporting groups
841130|NCT01259713|B2|Baseline|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841131|NCT01259713|B1|Baseline|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841132|NCT01259713|P2|Participant Flow|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841133|NCT01259713|P1|Participant Flow|Liposomal Amphotericin B|Liposomal amphotericin B (AmBisome®) 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841134|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841135|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841136|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841137|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841138|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841139|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841140|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841141|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841142|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841143|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841144|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841145|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841146|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841147|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841148|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841149|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841150|NCT01259713|O2|Outcome|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841151|NCT01259713|O1|Outcome|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841152|NCT01259713|E2|Reported Event|Placebo|Placebo to match liposomal amphotericin B twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841394|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration (in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
841153|NCT01259713|E1|Reported Event|Liposomal Amphotericin B|Liposomal amphotericin B 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
841155|NCT01259492|B4|Baseline|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841156|NCT01259492|B3|Baseline|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841157|NCT01259492|B2|Baseline|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841158|NCT01259492|B1|Baseline|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841159|NCT01259492|P4|Participant Flow|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841160|NCT01259492|P3|Participant Flow|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841161|NCT01259492|P2|Participant Flow|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841162|NCT01259492|P1|Participant Flow|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841163|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841164|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841790|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841278|NCT01259297|P6|Participant Flow|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
841165|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841166|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841167|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841168|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841169|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841170|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841171|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841172|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841173|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841174|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841429|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841879|NCT01256476|B2|Baseline|Pravastatin 40 mg Once a Day (QD)|
841175|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841176|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841177|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841178|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841179|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841180|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841181|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841182|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841183|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841184|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841252|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
841430|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841185|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841186|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841187|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
841188|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
841189|NCT01259492|O1|Outcome|ALL Ritalin LA Group|This group combined all Ritalin patients on 40 mg, 60 mg and 80 mg. n=492
841190|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841191|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841192|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841193|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841194|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841195|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841196|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841234|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841197|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841198|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841199|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841200|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841201|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841202|NCT01259492|O4|Outcome|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841203|NCT01259492|O3|Outcome|Ritalin LA 80 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841204|NCT01259492|O2|Outcome|Ritalin LA 60 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14.In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841205|NCT01259492|O1|Outcome|Ritalin LA 40 mg|In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2, continued in same dose till week 9. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 40 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841206|NCT01259492|E2|Reported Event|Placebo|Period 1- Placebo controlled Period 2 - The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose (40, 60 or 80 mg). In period 3, patients were re- randomized to either their optimal dose of medication (40, 60, or 80 mg/day) or Placebo from beginning of week 15 to end of week 40.
841235|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
841880|NCT01256476|B1|Baseline|Pitavastatin 4 mg Once a Day (QD)|
841207|NCT01259492|E1|Reported Event|All Ritalin LA|"All Ritalin LA:~In period 1 patients were given Ritalin LA 20 mg and up titrated to 40 mg at week 2 and to 60 mg at week 3 and to 80 mg at week 4. Period 2- The dose of study medication was re-titrated for all patients (including those in the Placebo arm during Period 1) starting at 20 mg/day Ritalin LA and increased at weekly intervals in increments of 20 mg/day until reaching the patient’s optimal dose 60 mg. Optimal dose was defined as the dose at which the investigator considered an optimal balance between control of symptoms and side effects was maintained for a period of at least one week prior to Week 14. In period 3, patients continued on their optimal dose."
841208|NCT01259466|B3|Baseline|Total|Total of all reporting groups
841209|NCT01259466|B2|Baseline|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841210|NCT01259466|B1|Baseline|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841211|NCT01259466|P2|Participant Flow|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841212|NCT01259466|P1|Participant Flow|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841213|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841214|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841215|NCT01259466|O2|Outcome|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841216|NCT01259466|O1|Outcome|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841217|NCT01259466|E2|Reported Event|Health Education + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841218|NCT01259466|E1|Reported Event|Cognitive Behavioral Treatment + Nicotine Replacement|Nicotine patch: Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
841219|NCT01259440|B3|Baseline|Total|Total of all reporting groups
841220|NCT01259440|B2|Baseline|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
841221|NCT01259440|B1|Baseline|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
841222|NCT01259440|P2|Participant Flow|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
841223|NCT01259440|P1|Participant Flow|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
841224|NCT01259440|O2|Outcome|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
841225|NCT01259440|O1|Outcome|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
841226|NCT01259440|E2|Reported Event|Usual Care|Usual Care: Consists of one week telephone call and one month clinic visit
841227|NCT01259440|E1|Reported Event|Video Teleconferencing Care|Video Teleconferencing Care: The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
841228|NCT01259427|B3|Baseline|Total|Total of all reporting groups
841229|NCT01259427|B2|Baseline|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
841230|NCT01259427|B1|Baseline|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841231|NCT01259427|P2|Participant Flow|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
841232|NCT01259427|P1|Participant Flow|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841233|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
841251|NCT01259401|P1|Participant Flow|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
841881|NCT01256476|P2|Participant Flow|Pravastatin 40 mg Once a Day (QD)|
841236|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841237|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
841238|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841239|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc.).
841240|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841241|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
841242|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841243|NCT01259427|O2|Outcome|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
841244|NCT01259427|O1|Outcome|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841245|NCT01259427|E2|Reported Event|Arm 2: Health and Wellness Group|Health and Wellness Group: The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
841246|NCT01259427|E1|Reported Event|Arm 1: Ending Self Stigma|Ending Self Stigma (ESS): Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
841247|NCT01259401|B3|Baseline|Total|Total of all reporting groups
841248|NCT01259401|B2|Baseline|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
841249|NCT01259401|B1|Baseline|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
841250|NCT01259401|P2|Participant Flow|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
841431|NCT01259115|E2|Reported Event|BTDS With Placebo|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole placebo oral tablets twice daily.
841882|NCT01256476|P1|Participant Flow|Pitavastatin 4 mg Once a Day (QD)|
841253|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
841254|NCT01259401|O2|Outcome|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
841255|NCT01259401|O1|Outcome|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
841256|NCT01259401|E2|Reported Event|Control Group|"The control group received basic sleep education, delivered in 4 individual sessions carried out within the Adult Day Health Care~Sleep Education control: During sessions, participants reviewd two educational brochures that focused on changes in sleep with age and sleep hygiene education."
841257|NCT01259401|E1|Reported Event|SIP Group|"The SIP group received a sleep education program based on behavioral principles, delivered in 4 individual sessions carried out within the Adult Day Health Care program.~Sleep Intervention Program: Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia."
841258|NCT01259375|B1|Baseline|All Groups|All patients that received treatment.
841259|NCT01259375|P1|Participant Flow|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
841260|NCT01259375|O1|Outcome|All Groups|All patients who had a partial or greater response
841261|NCT01259375|O1|Outcome|All Patients|"All participants who received Amrubicin.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
841262|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
841263|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
841264|NCT01259375|O1|Outcome|All Patients|"All participants who received Amrubicin.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
841265|NCT01259375|O1|Outcome|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
841266|NCT01259375|E1|Reported Event|All Patients|"All participants enrolled.~Amrubicin: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously"
841267|NCT01259297|B9|Baseline|Total|Total of all reporting groups
841268|NCT01259297|B8|Baseline|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
841269|NCT01259297|B7|Baseline|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were run-in stratum randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
841270|NCT01259297|B6|Baseline|Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
841271|NCT01259297|B5|Baseline|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
841272|NCT01259297|B4|Baseline|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
841273|NCT01259297|B3|Baseline|Aliskiren + Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
841274|NCT01259297|B2|Baseline|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
841275|NCT01259297|B1|Baseline|Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
841276|NCT01259297|P8|Participant Flow|Placebo for Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
841277|NCT01259297|P7|Participant Flow|Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
841299|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
841279|NCT01259297|P5|Participant Flow|HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
841280|NCT01259297|P4|Participant Flow|Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
841281|NCT01259297|P3|Participant Flow|Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
841282|NCT01259297|P2|Participant Flow|Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
841283|NCT01259297|P1|Participant Flow|Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~In double blind period, all patients who successfully completed run-in with HCTZ plus aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
841284|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
841285|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
841286|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
841287|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
841288|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
841289|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
841290|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
841291|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
841292|NCT01259297|O2|Outcome|Placebo|This reporting group includes all the patients who has received placebo of aliskiren plus placebo of an additional BP lowering drug (amlodipine or hydrochlorothiazide). This reporting group includes patients from arms such as Placebo for Aliskiren + Placebo for HCTZ and Placebo for aliskiren + Placebo for Amlodipine .
841293|NCT01259297|O1|Outcome|Aliskiren+Amlodipine/HCTZ Group|This reporting group includes all the patients who has received Aliskiren plus an additional BP lowering drug (Amlodipine or Hydrochlorothiazide). This reporting group includes patients from arms such as Aliskiren + Hydrochlorothiazide (HCTZ) and Aliskiren + Amlodipine.
841294|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
841295|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
841296|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
841297|NCT01259297|O1|Outcome|Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that included Aliskiren such as Aliskiren + Hydrochlorothiazide (HCTZ), Aliskiren + placebo for HCTZ, Aliskiren + Amlodipine, Aliskiren + placebo for Amlodipine.
841298|NCT01259297|O2|Outcome|Non-Aliskiren Based Regimen|This regimen includes all the patients who were randomized to the treatment arms that did not include Aliskiren such as HCTZ + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for HCTZ, Amlodipine + Placebo for Aliskiren, Placebo for Aliskiren + Placebo for Amlodipine
841300|NCT01259297|E10|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for Amlod|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for Amlodipine 5 mg once daily"
841301|NCT01259297|E9|Reported Event|Double Blind Period: Amlodipine + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Amlodipine 5 mg + placebo for Aliskiren 300 mg once daily"
841302|NCT01259297|E8|Reported Event|Double Blind Period: Placebo for Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received placebo for Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
841303|NCT01259297|E7|Reported Event|Double Blind Period: HCTZ + Placebo for Aliskiren|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received HCTZ 25 mg + placebo for Aliskiren 300 mg once daily"
841304|NCT01259297|E6|Reported Event|Double Blind Period: Aliskiren + Placebo for Amlodipine|"In double blind period, all patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for Amlodipine 5 mg"
841305|NCT01259297|E5|Reported Event|Double Blind Period: Aliskiren + Amlodipine|"In double blind period, patients who successfully completed run-in with Amlodipine plus Aliskiren were randomized equally to the 4 arms of the Amlodipine add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
841306|NCT01259297|E4|Reported Event|Double Blind Period: Aliskiren + Placebo for HCTZ|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~In double blind period, randomized patients to this arm received Aliskiren 300 mg + placebo for HCTZ 25 mg once daily"
841307|NCT01259297|E3|Reported Event|Double Blind Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In double blind period, all patients who successfully completed run-in with HCTZ plus Aliskiren were randomized equally to the 4 arms of the HCTZ add-on stratum.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
841308|NCT01259297|E2|Reported Event|Run-in Period: Aliskiren + Amlodipine|"In run-in period (4-5 weeks) , patients on thiazide background therapy and approximately 50% of patients on neither CCB nor thiazide background therapy received Amlodipine 5 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + Amlodipine 5 mg once daily during the double blind period."
841309|NCT01259297|E1|Reported Event|Run-in Period: Aliskiren + Hydrochlorothiazide (HCTZ)|"In run-in period (4-5 weeks) , patients on CCB background therapy and approximately 50% of patients on neither thiazide nor CCB background therapy: received Hydrochlorothiazide 12.5/25 mg and Aliskiren 150/300 mg daily in a titrated manner as per protocol.~Patients randomized to this arm received Aliskiren 300 mg + HCTZ 25 mg once daily."
841310|NCT01259284|B4|Baseline|Total|Total of all reporting groups
841311|NCT01259284|B3|Baseline|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
841312|NCT01259284|B2|Baseline|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
841313|NCT01259284|B1|Baseline|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
841314|NCT01259284|P3|Participant Flow|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
841315|NCT01259284|P2|Participant Flow|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
841316|NCT01259284|P1|Participant Flow|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
841317|NCT01259284|O3|Outcome|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
841318|NCT01259284|O2|Outcome|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
841319|NCT01259284|O1|Outcome|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
841320|NCT01259284|E3|Reported Event|Placebo|4 capsules orally every morning and 3 every evening for 5 days pre-surgery.
841321|NCT01259284|E2|Reported Event|Fish Oil Supplement|3 Fish Oil capsules twice a day plus 1 Placebo capsule daily orally 5 days pre-surgery.
841322|NCT01259284|E1|Reported Event|Atorvastatin|1 Atorvastatin capsule daily plus 3 Placebo capsules twice a day orally, 5 days pre-surgery.
841323|NCT01259245|B3|Baseline|Total|Total of all reporting groups
841324|NCT01259245|B2|Baseline|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841325|NCT01259245|B1|Baseline|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841360|NCT01256944|B2|Baseline|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841362|NCT01256944|P2|Participant Flow|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
841363|NCT01256944|P1|Participant Flow|Control|The normal women
841326|NCT01259245|P2|Participant Flow|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841327|NCT01259245|P1|Participant Flow|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841328|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841329|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841330|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841331|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841332|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841333|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841334|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841335|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841336|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841361|NCT01256944|B1|Baseline|Control|The normal women
841432|NCT01259115|E1|Reported Event|BTDS With Ketoconazole|Subjects who were treated with buprenorphine transdermal patch 10 mcg/hour with ketoconazole 200 mg oral tablets twice daily.
841337|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841338|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841339|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841340|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841341|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841342|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841343|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841344|NCT01259245|O2|Outcome|PRP+Tai Chi|
841345|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|
841346|NCT01259245|O2|Outcome|Tai Chi + PRP|"Tai chi elements in incorporated into the exercise component of standard pulmonary rehabilitation program. The exercise content was totally identical to the PRP group except 15 minutes of Tai Chi exercises was substituted to 15 minutes of relaxation exercise. The 5 forms of Sun Style of Tai Chi were taught.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting~Tai chi + PRP : The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise"
841347|NCT01259245|O1|Outcome|Pulmonary Rehabilitation Program|"PRP is a formal pulmonary rehabilitation program consisted of physical training including warm up and cool down exercise and aerobic exercises in addition to breathing control exercises, safety precautions for physical training, Thera-Band strengthening exercises and overview of COPD management.~PRP : Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting"
841348|NCT01259245|E2|Reported Event|Pulmonary Rehabilitation Program PRP|Subjects who received formal pulmonary rehabilitation program
841349|NCT01259245|E1|Reported Event|PRP + Tai Chi|Tai Chi elements added to PRP program
841350|NCT01256983|B3|Baseline|Total|Total of all reporting groups
841351|NCT01256983|B2|Baseline|No Intervention|10000 Lux after day 63
841352|NCT01256983|B1|Baseline|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
841353|NCT01256983|P2|Participant Flow|No Intervention|10000 Lux after day 63
841354|NCT01256983|P1|Participant Flow|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
841355|NCT01256983|O2|Outcome|No Intervention|10000 Lux after day 63
841356|NCT01256983|O1|Outcome|Light Box|"10000 lux after day 21~Light Box : 10000 Lux for 30 Minutes according to sleep wake rhythm"
841357|NCT01256983|E2|Reported Event|Wait-list Intervention|Wait-list design Intervention. Bright Light Therapy with 10000 lux beginning at day 63 until day 84, when the 9 study weeks were over.
841358|NCT01256983|E1|Reported Event|Bright Light Therapy|Bright Light Therapy with 10000 lux beginning at day 21 until day 42
841359|NCT01256944|B3|Baseline|Total|Total of all reporting groups
841433|NCT01259102|B6|Baseline|Total|Total of all reporting groups
841364|NCT01256944|O4|Outcome|Nonb-obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
841365|NCT01256944|O3|Outcome|Non-obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI < 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841366|NCT01256944|O2|Outcome|Obese With Control|BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).
841367|NCT01256944|O1|Outcome|Obese With PCOS|"BMI categorization was based on the WHO Asia–Pacific classification for obesity, which was defined as BMI ≧ 25 kg/m2(WHO: Obesity: preventing and managing the global epidemic. Geneva: WHO; 2000).~Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841368|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841369|NCT01256944|O1|Outcome|Control|The normal women
841370|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841371|NCT01256944|O1|Outcome|Control|The normal women
841372|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841373|NCT01256944|O1|Outcome|Control|The normal women
841374|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841375|NCT01256944|O1|Outcome|Control|The normal women
841376|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841377|NCT01256944|O1|Outcome|Control|The normal women
841378|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841379|NCT01256944|O1|Outcome|Control|The normal women
841380|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841381|NCT01256944|O1|Outcome|Control|The normal women
841382|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841383|NCT01256944|O1|Outcome|Control|The normal women
841384|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841385|NCT01256944|O1|Outcome|Control|The normal women
841386|NCT01256944|O2|Outcome|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome)"
841387|NCT01256944|O1|Outcome|Control|The normal women
841388|NCT01256944|E2|Reported Event|PCOS|"Women who met the 2003 Rotterdam criteria, which require a minimum of two of the following three criteria:~Oligo- or anovulation~Clinical and/or biochemical signs of hyperandrogenism~Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome)"
841389|NCT01256944|E1|Reported Event|Control|The normal women
841390|NCT01256918|B1|Baseline|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
841391|NCT01256918|P1|Participant Flow|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
841395|NCT01256918|O1|Outcome|Nuclear Opalescence|nuclear grading as per LOCS III criteria for cataract.nuclear opalescence is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
841532|NCT01258803|B1|Baseline|All Randomized Participants|
841396|NCT01256918|O2|Outcome|Phacodepth|actual depth of penetration(in mm) of phacotip required to achieve a full thickness crack in vertical chop during phacoemulsification
841397|NCT01256918|O1|Outcome|Nuclear Colour|nuclear grading as per LOCS III criteria for cataract shall be done on a decimal scale from 0.1 to 6.9 nuclear colour is graded on a scale from 0.1 to 6.9 by comparing with standard photographs of cataract, under lens opacities classification system III, on a Haag Streit slit lamp under standard conditions of illumination
841398|NCT01256918|O1|Outcome|Posterior Capsular Rupture|A note shall be made of any posterior capsular rupture attributable to the attempted vertical chop during the phacoemulsification procedure.
841399|NCT01256918|O1|Outcome|Phacodepth|A note shall be made of the phacodepth at which a complete vertical chop is achieved during the attempted vertical chop .
841400|NCT01256918|E1|Reported Event|Patients Undergoing Phacoemulsification|Patients (> 40 years of age) with grade 3.0 to 6.9( according to LOCS-III) of senile cataract were included in this study.200 consecutive patients were enrolled and achievement of milestone noted while attempting vertical chop during phacoemulsification using a calibrated phacotip.
841401|NCT01259115|B1|Baseline|Overall Study|Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 1; Washout Period for 4 to 18 days; Subjects received BTDS 10 with ketoconazole 200 mg or ketoconazole placebo tablets twice daily in period 2.
841402|NCT01259115|P2|Participant Flow|Sequence B: BTDS 10 With Placebo (Reference) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo tablets twice daily (Reference) first~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole 200 mg tablets twice daily."
841403|NCT01259115|P1|Participant Flow|Sequence A: BTDS 10 With Ketoconazole (Test) First|"Period 1: Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily (Test) first;~Washout Period of 4 to 18 days;~Period 2: BTDS 10 with ketoconazole placebo tablets twice daily."
841404|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine transdermal system (BTDS) 10 with ketoconazole placebo oral tablets twice daily.
841405|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Buprenorphine transdermal system (BTDS) 10 with ketoconazole 200 mg tablets twice daily.
841406|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
841407|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
841408|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
841409|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
841410|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Buprenorphine-3-glucuronide was not measured in the plasma during treatment
841411|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|BTDS 10 with ketoconazole 200 mg tablets twice daily
841412|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841413|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841414|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841415|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841416|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841417|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841418|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841419|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841420|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841421|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841422|NCT01259115|O1|Outcome|All Subjects|Subjects who received BTDS with Ketoconazole treatment
841423|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841424|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841425|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841426|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841427|NCT01259115|O2|Outcome|BTDS 10 With Ketoconazole Placebo|Period 1: BTDS 10 with ketoconazole placebo tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole 200 mg twice daily.
841428|NCT01259115|O1|Outcome|BTDS 10 With Ketoconazole|Period 1: BTDS 10 with ketoconazole 200 mg tablets twice daily; Washout: Day 12 to 15; Period 2: BTDS 10 with ketoconazole placebo tablets twice daily.
841434|NCT01259102|B5|Baseline|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841435|NCT01259102|B4|Baseline|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841436|NCT01259102|B3|Baseline|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841437|NCT01259102|B2|Baseline|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841438|NCT01259102|B1|Baseline|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841439|NCT01259102|P5|Participant Flow|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841440|NCT01259102|P4|Participant Flow|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841441|NCT01259102|P3|Participant Flow|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841442|NCT01259102|P2|Participant Flow|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841443|NCT01259102|P1|Participant Flow|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841444|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841445|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841446|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841447|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841448|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841449|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841450|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841451|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841452|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841453|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841454|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841455|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841456|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841457|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841458|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841459|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841460|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841461|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841462|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841463|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841464|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841465|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841466|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841467|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841468|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841469|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841470|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841471|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841472|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841473|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841883|NCT01256476|O2|Outcome|Pravastatin 40 mg Once Daily (QD)|
841474|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841475|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841476|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841477|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841478|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841479|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841480|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841481|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841482|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841483|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841484|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841485|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841486|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841487|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841488|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841489|NCT01259102|O5|Outcome|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841490|NCT01259102|O4|Outcome|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841491|NCT01259102|O3|Outcome|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841492|NCT01259102|O2|Outcome|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841493|NCT01259102|O1|Outcome|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841884|NCT01256476|O1|Outcome|Pitavastatin 4 mg Once Daily (QD)|
841494|NCT01259102|E5|Reported Event|28-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 28 days between the removal of BTDS and placement of the second BTDS in the same location.
841495|NCT01259102|E4|Reported Event|21-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 21 days between the removal of BTDS and placement of the second BTDS in the same location.
841496|NCT01259102|E3|Reported Event|14-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 14 days between the removal of BTDS and placement of the second BTDS in the same location.
841497|NCT01259102|E2|Reported Event|7-Day Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 7 days between the removal of BTDS and placement of the second BTDS in the same location.
841498|NCT01259102|E1|Reported Event|No Rest|Each subject applied BTDS (10 mcg/h) on 2 occasions and wore it for 7 days (168 hours). Subjects were assigned to 1 of 5 treatment groups with different application site rest periods from 0 to 4 weeks. For this group, the rest period was 0 days between the removal of BTDS and placement of the second BTDS in the same location.
841499|NCT01258998|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
841500|NCT01258998|P1|Participant Flow|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
841501|NCT01258998|O1|Outcome|Akt Inhibitor MK2206|Akt inhibitor MK2206 200 mg orally once a week, repeats every 28 days for up to 12 courses.
841502|NCT01258998|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 orally once a week, repeats every 28 days for up to 12 courses.
841503|NCT01258985|B3|Baseline|Total|Total of all reporting groups
841504|NCT01258985|B2|Baseline|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841505|NCT01258985|B1|Baseline|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841506|NCT01258985|P2|Participant Flow|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841507|NCT01258985|P1|Participant Flow|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841508|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841509|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841510|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841511|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841512|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841513|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841514|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841515|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841516|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841517|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841518|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841519|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841520|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841521|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841522|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841523|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841524|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841525|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841526|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841527|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841528|NCT01258985|O2|Outcome|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841529|NCT01258985|O1|Outcome|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841530|NCT01258985|E2|Reported Event|Physical Therapy|"6 weeks of individualized Physical Therapy followed by 6 weeks of Supervised Home Exercise~Physical Therapy: 6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise"
841531|NCT01258985|E1|Reported Event|Tai Chi|"12 weeks of Tai Chi classes~Tai Chi: 12 weeks of Tai Chi"
841533|NCT01258803|P6|Participant Flow|Treatment Sequence 6|Treatment Period 1: MF/F MDI with spacer, Treatment Period 2: Placebo MDI without spacer, Treatment Period 3: MF/F MDI without spacer, Treatment Period 4: F DPI
841534|NCT01258803|P5|Participant Flow|Treatment Sequence 5|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI without spacer
841535|NCT01258803|P4|Participant Flow|Treatment Sequence 4|Treatment Period 1: Placebo MDI without spacer, Treatment Period 2: MF/F MDI with spacer, Treatment Period 3: F DPI, Treatment Period 4: MF/F MDI without spacer
841536|NCT01258803|P3|Participant Flow|Treatment Sequence 3|Treatment Period 1: MF/F MDI without spacer, Treatment Period 2: F DPI, Treatment Period 3: Placebo MDI with spacer, Treatment Period 4: MF/F MDI with spacer
841537|NCT01258803|P2|Participant Flow|Treatment Sequence 2|Treatment Period 1: F DPI, Treatment Period 2: MF/F MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: Placebo MDI with spacer
841538|NCT01258803|P1|Participant Flow|Treatment Sequence 1|Treatment Period 1: Placebo Metered Dose Inhaler (MDI) with spacer, Treatment Period 2: Mometasone Furoate/Formoterol Fumarate (MF/F) MDI without spacer, Treatment Period 3: MF/F MDI with spacer, Treatment Period 4: F Dry Powder Inhaler (DPI)
841539|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
841540|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
841541|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
841542|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
841543|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
841544|NCT01258803|O1|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
841545|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
841546|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
841547|NCT01258803|O2|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
841548|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
841549|NCT01258803|O4|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
841550|NCT01258803|O3|Outcome|F DPI|Participants receiving a single dose of F DPI 20 mcg
841551|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
841552|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
841553|NCT01258803|O2|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
841554|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
841555|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
841556|NCT01258803|O1|Outcome|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
841557|NCT01258803|O2|Outcome|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
841558|NCT01258803|O1|Outcome|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
841559|NCT01258803|E4|Reported Event|Placebo MDI With or Without Spacer|Participants receiving a single dose of Placebo MDI with or without a spacer
841560|NCT01258803|E3|Reported Event|F DPI|Participants receiving a single dose of F DPI 20 mcg
841561|NCT01258803|E2|Reported Event|MF/F MDI Without Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg without a spacer
841562|NCT01258803|E1|Reported Event|MF/F MDI With Spacer|Participants receiving a single dose of MF/F MDI 100/10 mcg with a spacer
841563|NCT01258790|B3|Baseline|Total|Total of all reporting groups
841564|NCT01258790|B2|Baseline|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841565|NCT01258790|B1|Baseline|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841566|NCT01258790|P2|Participant Flow|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841567|NCT01258790|P1|Participant Flow|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841568|NCT01258790|O2|Outcome|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841569|NCT01258790|O1|Outcome|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841570|NCT01258790|E2|Reported Event|Sham Repetitive Transcranial Magnetic Stimulation|In the sham arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim sham 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841571|NCT01258790|E1|Reported Event|Active Repetitive Transcranial Magnetic Stimulation|In the active arm, patients received 8 sessions of active continuous theta burst stimulation (cTBS) over 2 consecutive days. Four 40-second cTBS sessions were given over a 75-minute period (0, 15, 60, 75 minute marks) for each day. We used Magstim 70mm figure-8 TMS coil, placed over SMA, with the coil handle pointing towards the occiput.
841572|NCT01258738|B3|Baseline|Total|Total of all reporting groups
841573|NCT01258738|B2|Baseline|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841574|NCT01258738|B1|Baseline|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841575|NCT01258738|P2|Participant Flow|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841576|NCT01258738|P1|Participant Flow|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841577|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841578|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841579|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841580|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841581|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841582|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841583|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841584|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841585|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841586|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841587|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841735|NCT01258595|P1|Participant Flow|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841588|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841589|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841590|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841591|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841592|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841593|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841594|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841595|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841596|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841597|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841598|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841599|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841600|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841601|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841602|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841603|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841604|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841605|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841606|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841607|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841608|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841609|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841610|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841611|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841612|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841613|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841614|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841615|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841616|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841617|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841618|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841619|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841620|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841621|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841622|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841623|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841624|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841625|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841626|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841627|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841628|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841629|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841630|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841631|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841632|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841633|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841634|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841635|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841636|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841637|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841638|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841639|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841640|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841641|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841642|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841643|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841644|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841645|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841646|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841647|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841648|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841649|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841650|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841651|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841652|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841653|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841654|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841655|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841656|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841657|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841658|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841659|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841660|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841661|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841662|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841663|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841664|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841665|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841666|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841667|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841668|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841669|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841670|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841671|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841672|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841673|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841674|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841675|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841676|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841677|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841678|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841679|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841680|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841681|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841682|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841683|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841684|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841685|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841686|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841687|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841688|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841689|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841690|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841691|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841692|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841693|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841694|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841695|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841696|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841697|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841698|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841699|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841700|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841701|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841702|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841703|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841704|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841705|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841706|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841707|NCT01258738|O2|Outcome|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841708|NCT01258738|O1|Outcome|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background non-steroidal anti-inflammatory drug (NSAID) at optimal anti-inflammatory dose for 12 weeks (double-blind period). All participants who completed the 12-week double-blind period entered into a 92 week open-label period and received etanercept 50 mg once weekly and background NSAID.
841709|NCT01258738|E2|Reported Event|Placebo|Participants were treated with placebo subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
841710|NCT01258738|E1|Reported Event|Etanercept|Participants were treated with etanercept subcutaneous injection weekly plus stable background NSAID at optimal anti-inflammatory dose for 12 weeks (double-blind period).
841711|NCT01258660|B3|Baseline|Total|Total of all reporting groups
841712|NCT01258660|B2|Baseline|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841713|NCT01258660|B1|Baseline|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841714|NCT01258660|P2|Participant Flow|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841715|NCT01258660|P1|Participant Flow|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841716|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841717|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841718|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841736|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841885|NCT01256476|E2|Reported Event|Pravastatin 40 mg Once a Day (QD)|
841737|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841738|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841719|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841720|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841721|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841722|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841723|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841724|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841725|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841726|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841727|NCT01258660|O2|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841728|NCT01258660|O1|Outcome|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841729|NCT01258660|E2|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin) + Folic Acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841730|NCT01258660|E1|Reported Event|EE 0.03 mg/DRSP 3 mg/Metafolin + Folic Acid Placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
841731|NCT01258595|B3|Baseline|Total|Total of all reporting groups
841732|NCT01258595|B2|Baseline|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841733|NCT01258595|B1|Baseline|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841734|NCT01258595|P2|Participant Flow|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841886|NCT01256476|E1|Reported Event|Pitavastatin 4 mg Once a Day (QD)|
841739|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841740|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841741|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841742|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841743|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841744|NCT01258595|O2|Outcome|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841745|NCT01258595|O1|Outcome|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841746|NCT01258595|E2|Reported Event|Fluzone® Vaccine Group|Participants who received a single dose of Fluzone® vaccine, containing 15 µg hemagglutinin on Day 0
841747|NCT01258595|E1|Reported Event|Fluzone® High-Dose Vaccine Group|Participants who received a single dose of Fluzone® High-Dose vaccine, containing 60 µg hemagglutinin on Day 0
841748|NCT01258582|B3|Baseline|Total|Total of all reporting groups
841749|NCT01258582|B2|Baseline|Oral Fluid|Oral fluid rapid HIV testing
841750|NCT01258582|B1|Baseline|Fingerstick|Fingerstick rapid HIV testing
841751|NCT01258582|P2|Participant Flow|Oral Fluid|Oral fluid rapid HIV testing
841752|NCT01258582|P1|Participant Flow|Fingerstick|Fingerstick rapid HIV testing
841753|NCT01258582|O2|Outcome|Oral HIV Testing|oral fluid rapid HIV testing
841754|NCT01258582|O1|Outcome|Fingerstick HIV Testing|whole-blood fingerstick rapid HIV testing
841755|NCT01258582|E2|Reported Event|Oral Fluid|Oral fluid rapid HIV testing
841756|NCT01258582|E1|Reported Event|Fingerstick|Fingerstick rapid HIV testing
841757|NCT01258504|B1|Baseline|Bosentan|bosentan 125 mg p.o. day 1 single dose bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
841758|NCT01258504|P1|Participant Flow|Bosentan|bosentan 125 mg p.o. single dose day 1 bosentan 62.5 mg p.o. b.i.d. day 2-10 bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg p.o. t.i.d. day 11-20
841759|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
841760|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
841761|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan125 mg p.o. day 1 single dose
841762|NCT01258504|O3|Outcome|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
841763|NCT01258504|O2|Outcome|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
841764|NCT01258504|O1|Outcome|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
841765|NCT01258504|E3|Reported Event|Bosentan During St John's Wort|bosentan 62.5 mg p.o. b.i.d. day 11-20 SJW 300 mg t.i.d. day 11-20
841766|NCT01258504|E2|Reported Event|Bosentan at Steady-state|bosentan 62.5 mg p.o. b.i.d. day 2-10
841767|NCT01258504|E1|Reported Event|Bosentan After First Dose|bosentan 125 mg p.o. day 1 single dose
841768|NCT01256684|B4|Baseline|Total|Total of all reporting groups
841769|NCT01256684|B3|Baseline|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841770|NCT01256684|B2|Baseline|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841771|NCT01256684|B1|Baseline|Placebo|Placebo: Placebo vaginal suppository
841772|NCT01256684|P3|Participant Flow|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841773|NCT01256684|P2|Participant Flow|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841774|NCT01256684|P1|Participant Flow|Placebo|Placebo: Placebo vaginal suppository
841775|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841776|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841777|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841778|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841779|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841780|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841781|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841782|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841783|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841784|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841785|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841786|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841787|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841788|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841789|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841791|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841792|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
846785|NCT01243242|E2|Reported Event|Placebo|Eligible subjects who received 1400 mg of Placebo
841794|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841795|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841796|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841797|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841798|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841799|NCT01256684|O3|Outcome|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841800|NCT01256684|O2|Outcome|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841801|NCT01256684|O1|Outcome|Placebo|Placebo: Placebo vaginal suppository
841802|NCT01256684|E3|Reported Event|0.50% DHEA|DHEA: Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
841803|NCT01256684|E2|Reported Event|0.25% DHEA|DHEA: Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
841804|NCT01256684|E1|Reported Event|Placebo|Placebo: Placebo vaginal suppository
841805|NCT01256658|B3|Baseline|Total|Total of all reporting groups
841806|NCT01256658|B2|Baseline|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841807|NCT01256658|B1|Baseline|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841808|NCT01256658|P2|Participant Flow|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841809|NCT01256658|P1|Participant Flow|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841810|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841811|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841812|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841813|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841814|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841815|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841816|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841817|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841818|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841819|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841820|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
841821|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841822|NCT01256658|O2|Outcome|Control|Not applicable to this outcome measure
841823|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841824|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841825|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841826|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841827|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841828|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841829|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841830|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841831|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841832|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841833|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841834|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841835|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841836|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841837|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841838|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841839|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841840|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841887|NCT01258387|B9|Baseline|Total|Total of all reporting groups
841841|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841842|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841893|NCT01258387|B3|Baseline|GGF2 Second Escalated Dose|Second dosing: patients in cohort randomized to GGF2
841843|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841844|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841845|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841846|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841847|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841848|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841849|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841850|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841851|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841852|NCT01256658|O2|Outcome|Control|Participants received COA566 treatment for symptomatic malaria episodes only.
841853|NCT01256658|O1|Outcome|Intervention|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841854|NCT01256658|E4|Reported Event|Control - Period 2- Follow-up Only|Participants from the control group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
841855|NCT01256658|E3|Reported Event|Intervention - Period 2 - Follow-up Only|Participants from the intervention group of period 1 were followed up to assess longer term impact of initial intervention on malaria episodes. No treatment was given to participants during period 2.
841856|NCT01256658|E2|Reported Event|Control - Period 1|Participants received COA566 treatment for symptomatic malaria episodes only.
841857|NCT01256658|E1|Reported Event|Intervention - Period 1|Participants received COA566 treatment for asymptomatic carriage of P. falciparum and for symptomatic malaria episodes.
841858|NCT01256567|B1|Baseline|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841859|NCT01256567|P1|Participant Flow|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab (IMC-1121B) administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841860|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841861|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel : Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab : Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841862|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841863|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841864|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841865|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841866|NCT01256567|O1|Outcome|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841867|NCT01256567|E1|Reported Event|Ramucirumab and Docetaxel Combination|"Docetaxel: Docetaxel administered by intravenous infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.~Ramucirumab: Ramucirumab administered as an intravenous infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks."
841868|NCT01256502|B1|Baseline|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
841869|NCT01256502|P1|Participant Flow|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
841870|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
841871|NCT01256502|O5|Outcome|Very Easy to Use|
841872|NCT01256502|O4|Outcome|Easy to Use|
841873|NCT01256502|O3|Outcome|Neither Difficult Nor Easy to Use|
841874|NCT01256502|O2|Outcome|Difficult to Use|
841875|NCT01256502|O1|Outcome|Very Difficult to Use|
841876|NCT01256502|O1|Outcome|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
841877|NCT01256502|E1|Reported Event|Implanted Participants|Participants with breast reconstruction surgery implanted with SERI® Surgical Scaffold.
841878|NCT01256476|B3|Baseline|Total|Total of all reporting groups
841889|NCT01258387|B7|Baseline|GGF2 Sixth Escalated Dose|Sixth dosing: patients in cohort randomized to GGF2.
841890|NCT01258387|B6|Baseline|GGF2 Fifth Escalated Dose|Fifth dosing: patients in cohort randomized to GGF2
841896|NCT01258387|P7|Participant Flow|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
841897|NCT01258387|P6|Participant Flow|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed .
841898|NCT01258387|P5|Participant Flow|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
841899|NCT01258387|P4|Participant Flow|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
841900|NCT01258387|P3|Participant Flow|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
841901|NCT01258387|P2|Participant Flow|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
841902|NCT01258387|P1|Participant Flow|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort randomized (3:1) and dosed
841903|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
841904|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
841905|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
841906|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
841907|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
841908|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
841909|NCT01258387|O2|Outcome|GGF2 First Dose|
841910|NCT01258387|O1|Outcome|Placebo|
841911|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
841912|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
841913|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
841914|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
841915|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
841916|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
841917|NCT01258387|O2|Outcome|GGF2 First Dose|
841918|NCT01258387|O1|Outcome|Placebo|
841919|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
841920|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
841921|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
841922|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
841923|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
841924|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
841925|NCT01258387|O2|Outcome|GGF2 First Dose|
841926|NCT01258387|O1|Outcome|Placebo|
841927|NCT01258387|O8|Outcome|GGF2 Seventh Escalataed Dose|
841928|NCT01258387|O7|Outcome|GGF2 Sixth Escalated Dose|
841929|NCT01258387|O6|Outcome|GGF2 Fifth Escalated Dose|
841930|NCT01258387|O5|Outcome|GGF2 Fourth Escalated Dose|
841931|NCT01258387|O4|Outcome|GGF2 Third Escalated Dose|
841932|NCT01258387|O3|Outcome|GGF2 Second Escalated Dose|
841933|NCT01258387|O2|Outcome|GGF2 First Dose|
841934|NCT01258387|O1|Outcome|Placebo|
841935|NCT01258387|E8|Reported Event|GGF2 Seventh Escalataed Dose|Seventh dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
841936|NCT01258387|E7|Reported Event|GGF2 Sixth Escalated Dose|Sixth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed .
841937|NCT01258387|E6|Reported Event|GGF2 Fifth Escalated Dose|Fifth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
841938|NCT01258387|E5|Reported Event|GGF2 Fourth Escalated Dose|Fourth dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
841939|NCT01258387|E4|Reported Event|GGF2 Third Escalated Dose|Third dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
841940|NCT01258387|E3|Reported Event|GGF2 Second Escalated Dose|Second dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
841941|NCT01258387|E2|Reported Event|GGF2 First Dose|First dosing: 1 GGF2, 1 pbo; if no drug-related dose-limiting toxicities in GGF2-treated patient, other 4 patients in cohort will be randomized (3:1) and dosed
841942|NCT01258387|E1|Reported Event|Placebo|
841943|NCT01258153|B4|Baseline|Total|Total of all reporting groups
841944|NCT01258153|B3|Baseline|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841945|NCT01258153|B2|Baseline|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841946|NCT01258153|B1|Baseline|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841947|NCT01258153|P3|Participant Flow|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841948|NCT01258153|P2|Participant Flow|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
841949|NCT01258153|P1|Participant Flow|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
841950|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841951|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution 0.5mg/kg: Oral administration once daily for 7 days
841952|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution 0.1mg/kg: Oral administration once daily for 7 days
841953|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841954|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
846882|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
841956|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841957|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841958|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841959|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841960|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841961|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841962|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841963|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841964|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841965|NCT01258153|O3|Outcome|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841966|NCT01258153|O2|Outcome|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841967|NCT01258153|O1|Outcome|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841968|NCT01258153|E3|Reported Event|Placebo|Placebo matching Nepadutant oral solution: Oral administration once daily for 7 days
841969|NCT01258153|E2|Reported Event|Nepadutant High Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841970|NCT01258153|E1|Reported Event|Nepadutant Low Dose|Nepadutant oral solution: Oral administration once daily for 7 days
841971|NCT01258101|B5|Baseline|Total|Total of all reporting groups
841972|NCT01258101|B4|Baseline|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841973|NCT01258101|B3|Baseline|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841974|NCT01258101|B2|Baseline|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841975|NCT01258101|B1|Baseline|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841976|NCT01258101|P4|Participant Flow|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841977|NCT01258101|P3|Participant Flow|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841978|NCT01258101|P2|Participant Flow|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841979|NCT01258101|P1|Participant Flow|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
841980|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841981|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841982|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841983|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841984|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841985|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841986|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841987|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841988|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842076|NCT01257880|E2|Reported Event|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
841989|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841990|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841991|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841992|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841993|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841994|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841995|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841996|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841997|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
841998|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
841999|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842000|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842001|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842002|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842003|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842004|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842005|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842006|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842007|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842008|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842009|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842010|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842011|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842012|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842013|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842014|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842015|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842016|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842017|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842018|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842019|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842020|NCT01258101|O4|Outcome|Peginterferon/Ribavirin 400 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842021|NCT01258101|O3|Outcome|Peginterferon/Ribavirin 800 mg (16 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842022|NCT01258101|O2|Outcome|Peginterferon/Ribavirin 400 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842023|NCT01258101|O1|Outcome|Peginterferon/Ribavirin 800 mg (24 Weeks)|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
846883|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
842024|NCT01258101|E4|Reported Event|Ribavirin 400 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842025|NCT01258101|E3|Reported Event|Ribavirin 800 mg/16W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 800 mg orally daily for 16 W. The untreated Follow-up was for 24 W.
842026|NCT01258101|E2|Reported Event|Ribavirin 400 mg/24W|Eligible participants were administered PEG-IFNα-2a 180 mcg SC once weekly + Ribavirin 400 mg orally daily for 24 W. The untreated Follow-up was for 24 W.
842027|NCT01258101|E1|Reported Event|Ribavirin 800 mg/24W|Eligible participants were administered peginterferon alfa-2a (PEG-IFNα-2a) 180 microgram (mcg) subcutaneously (SC) once weekly + Ribavirin 800 milligram (mg) orally daily for 24 weeks (W). The untreated Follow-up was for 24 W.
842028|NCT01258049|B3|Baseline|Total|Total of all reporting groups
842029|NCT01258049|B2|Baseline|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable
842030|NCT01258049|B1|Baseline|ArTiMist|"Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h.~Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable."
842031|NCT01258049|P2|Participant Flow|Quinine|A loading dose of 20 mg/kg was given over four hours and thereafter 10 mg/kg was given every eight hours until the subject was able to swallow. Thereafter, patients were given quinine syrup or crushed tablets (10 mg/kg every eight hours) or another suitable treatment to ensure they received at least seven days of therapy, or be converted to another suitable treatment or a suitable course of combination therapy, in accordance with national drugs policy where applicable.
842032|NCT01258049|P1|Participant Flow|ArTiMist|Doses of 3 mg/kg were administered sublingually at: 0 h, 8 h, 24 h, 36 h, 48 h, and 60 h. Following the initial six doses, subjects could, at the discretion of the Investigator receive a further four daily doses of 3 mg/kg ArTiMist™ to complete a seven day treatment course, or be converted to another suitable treatment or a suitable course of combination therapy in accordance with national drugs policy where applicable.
842033|NCT01258049|O2|Outcome|Quinine|
842034|NCT01258049|O1|Outcome|ArTiMist|
842035|NCT01258049|O2|Outcome|Quinine|
842036|NCT01258049|O1|Outcome|ArTiMist|
842037|NCT01258049|O2|Outcome|Quinine|
842038|NCT01258049|O1|Outcome|ArTiMist|
842039|NCT01258049|O2|Outcome|Quinine|
842040|NCT01258049|O1|Outcome|ArTiMist|
842041|NCT01258049|O2|Outcome|Quinine|
842042|NCT01258049|O1|Outcome|ArTiMist|
842043|NCT01258049|O2|Outcome|Quinine|
842044|NCT01258049|O1|Outcome|ArTiMist|
842045|NCT01258049|O2|Outcome|Quinine|
842046|NCT01258049|O1|Outcome|ArTiMist|
842047|NCT01258049|O2|Outcome|Quinine|
842048|NCT01258049|O1|Outcome|ArTiMist|
842049|NCT01258049|O2|Outcome|Quinine|
842050|NCT01258049|O1|Outcome|ArTiMist|
842051|NCT01258049|O2|Outcome|Quinine|
842052|NCT01258049|O1|Outcome|ArTiMist|
842053|NCT01258049|O2|Outcome|Quinine|
842054|NCT01258049|O1|Outcome|ArTiMist|
842055|NCT01258049|O2|Outcome|Quinine|
842056|NCT01258049|O1|Outcome|ArTiMist|
842057|NCT01258049|O2|Outcome|Quinine|
842058|NCT01258049|O1|Outcome|ArTiMist|
842059|NCT01258049|O2|Outcome|Quinine|
842060|NCT01258049|O1|Outcome|ArTiMist|
842061|NCT01258049|O2|Outcome|Quinine|
842062|NCT01258049|O1|Outcome|ArTiMist|
842063|NCT01258049|O2|Outcome|Quinine|
842064|NCT01258049|O1|Outcome|ArTiMist|
842065|NCT01258049|E2|Reported Event|Quinine|
842066|NCT01258049|E1|Reported Event|ArTiMist|
842067|NCT01257880|B3|Baseline|Total|Total of all reporting groups
842068|NCT01257880|B2|Baseline|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
842069|NCT01257880|B1|Baseline|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
842070|NCT01257880|P2|Participant Flow|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
842071|NCT01257880|P1|Participant Flow|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
842072|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
842073|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
842074|NCT01257880|O2|Outcome|Large PFO|Persons who have migraine aura and large PFO, as assessed by transcranial Doppler evaluation.
842075|NCT01257880|O1|Outcome|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
842077|NCT01257880|E1|Reported Event|Control (Absence of PFO)|Persons who have migraine aura and no evidence of PFO, based on transcranial Doppler evaluation.
842078|NCT01257750|B1|Baseline|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
842079|NCT01257750|P1|Participant Flow|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
842138|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842080|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
842081|NCT01257750|O1|Outcome|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
842082|NCT01257750|E1|Reported Event|Pazopanib|"This is a single site, open label, safety and efficacy study of pazopanib (5mg/ml) where all 20 patients with corneal neovascularization in a single arm will receive pazopanib in one eye.~Frequency and Duration: 4 times per day for 3 weeks"
842083|NCT01257581|B4|Baseline|Total|Total of all reporting groups
842084|NCT01257581|B3|Baseline|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842085|NCT01257581|B2|Baseline|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842086|NCT01257581|B1|Baseline|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842087|NCT01257581|P3|Participant Flow|Tamoxifen 80mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
842088|NCT01257581|P2|Participant Flow|Tamoxifen 40mg|"Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Tamoxifen is approved by the U.S. Food and Drug Administration (FDA) for breast cancer treatment but is not approved for treating ALS.~tamoxifen: Tamoxifen citrate capsules"
842089|NCT01257581|P1|Participant Flow|Creatine 30gm|"Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.~This is a blinded study, so neither participants nor study staff will know which treatment a volunteer is receiving.~Creatine is a nutritional supplement and is not approved by the U.S. Food and Drug Administration (FDA) for treating ALS.~creatine: creatine monohydrate powder"
842090|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842091|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842092|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842093|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842094|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842095|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842096|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842097|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842098|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842099|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842100|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842101|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842133|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842102|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842103|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842104|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842105|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842106|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842107|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842108|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842109|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842110|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842111|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842112|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842113|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842114|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842115|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842116|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842117|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842118|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842119|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842120|NCT01257581|O3|Outcome|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842121|NCT01257581|O2|Outcome|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842122|NCT01257581|O1|Outcome|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842123|NCT01257581|E3|Reported Event|Tamoxifen 80mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 80mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842124|NCT01257581|E2|Reported Event|Tamoxifen 40mg|Tamoxifen will be taken as capsules twice a day. Volunteers in this arm will take a total of 40mg of tamoxifen per day for 38 weeks. Volunteers will also take placebo powder twice a day for 38 weeks.
842125|NCT01257581|E1|Reported Event|Creatine 30gm|Creatine will be taken as a powder mixed into food or liquid twice a day. Volunteers in this arm will take a total of 30gm of creatine per day for 38 weeks. Volunteers will also take placebo capsules twice a day for 38 weeks.
842126|NCT01257542|B3|Baseline|Total|Total of all reporting groups
842127|NCT01257542|B2|Baseline|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842128|NCT01257542|B1|Baseline|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842129|NCT01257542|P2|Participant Flow|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842130|NCT01257542|P1|Participant Flow|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842131|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842132|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842134|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842135|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842136|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842137|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
846884|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
842139|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842140|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842141|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842142|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842143|NCT01257542|O2|Outcome|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842144|NCT01257542|O1|Outcome|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842145|NCT01257542|E2|Reported Event|Dextromethorphan Hydrobromide|Single oral dose of 15 mg (10 mL) dextromethorphan hydrobromide syrup [7.5 mg/5 milliliter (mL)].
842146|NCT01257542|E1|Reported Event|Placebo|Single oral dose of placebo solution matched to 15 milligram (mg) [10 milliliter (mL/)] dextromethorphan hydrobromide.
842147|NCT01257503|B3|Baseline|Total|Total of all reporting groups
842148|NCT01257503|B2|Baseline|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842149|NCT01257503|B1|Baseline|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842150|NCT01257503|P2|Participant Flow|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842151|NCT01257503|P1|Participant Flow|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842152|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842153|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842154|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842155|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842156|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842157|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842158|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842159|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842160|NCT01257503|O2|Outcome|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842161|NCT01257503|O1|Outcome|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842162|NCT01257503|E2|Reported Event|Placebo|"5 ml of placebo given by mouth up to 6 times per day as needed for cold symptoms~placebo: liquid made to look like the active homeopathic remedy"
842163|NCT01257503|E1|Reported Event|Homeopathic Cold Remedy|"5 ml of homeopathic cold remedy given by mouth up to 6 times per day as needed for cold symptoms~Hyland's Cold 'n Cough 4 kids: 5 ml PO q4h prn cold symptoms"
842164|NCT01257438|B3|Baseline|Total|Total of all reporting groups
842165|NCT01257438|B2|Baseline|PTA Only|PTA only: Treatment of in-stent restenosis
842166|NCT01257438|B1|Baseline|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
842167|NCT01257438|P2|Participant Flow|PTA Only|PTA only: Treatment of in-stent restenosis
842168|NCT01257438|P1|Participant Flow|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
842169|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
842170|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
842171|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
842172|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
842173|NCT01257438|O2|Outcome|PTA Only|PTA only: Treatment of in-stent restenosis
842174|NCT01257438|O1|Outcome|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
842175|NCT01257438|E2|Reported Event|PTA Only|PTA only: Treatment of in-stent restenosis
842176|NCT01257438|E1|Reported Event|Fluency|"Fluency Plus Endovascular Stent Graft~Fluency Plus Endovascular Stent Graft: Treatment of in-stent restenosis"
842177|NCT01257425|B3|Baseline|Total|Total of all reporting groups
842178|NCT01257425|B2|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842179|NCT01257425|B1|Baseline|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842180|NCT01257425|P2|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842181|NCT01257425|P1|Participant Flow|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842182|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842183|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842184|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842185|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842186|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842187|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842188|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842189|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842190|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842191|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842192|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842193|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842194|NCT01257425|O2|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842195|NCT01257425|O1|Outcome|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842196|NCT01257425|E2|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) IM.|Intramuscular (IM) application of triptorelin pamoate (Pamorelin LA 11.25 mg) administered on Day 1 and Day 85.
842197|NCT01257425|E1|Reported Event|Triptorelin Pamoate (Pamorelin® LA 11.25 mg) SC.|Subcutaneous (SC) application of triptorelin pamoate (Pamorelin LA 11.25 mg)administered on Day 1 and Day 85.
842198|NCT01257347|B5|Baseline|Total|Total of all reporting groups
842199|NCT01257347|B4|Baseline|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
842200|NCT01257347|B3|Baseline|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
842201|NCT01257347|B2|Baseline|Electronically-measuring Adherence|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
842202|NCT01257347|B1|Baseline|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
842203|NCT01257347|P4|Participant Flow|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
842204|NCT01257347|P3|Participant Flow|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
842258|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842259|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842260|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842261|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842262|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842263|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842268|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842269|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842270|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842271|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842272|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842205|NCT01257347|P2|Participant Flow|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
842206|NCT01257347|P1|Participant Flow|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.35 patients belonged to providers in the control group.
842207|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
842208|NCT01257347|O1|Outcome|Usual Care Control Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
842209|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Non-adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
842210|NCT01257347|O1|Outcome|Usual Care Control Group, Non-adherent Only|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
842211|NCT01257347|O2|Outcome|Electronically-measuring Adherence Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
842212|NCT01257347|O1|Outcome|Usual Care Control Group, Adherent Only|At clinical visits with patients with uncontrolled hypertension, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. Clinicians will be expected to manage hypertension according to usual care.
842213|NCT01257347|O2|Outcome|Electronically-measuring Adherence|At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
842214|NCT01257347|O1|Outcome|Usual Care Control Group|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.
842215|NCT01257347|E4|Reported Event|Electronically-Measuring Adherence Intervention: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
842216|NCT01257347|E3|Reported Event|Usual Care Control: Patients|Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
842264|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842265|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842266|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842267|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842217|NCT01257347|E2|Reported Event|Electronically-Measuring Adherence Intervention: Physicians|Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.
842218|NCT01257347|E1|Reported Event|Usual Care Control: Physicians|Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care. 35 patients belonged to providers in the control group.
842219|NCT01257230|B4|Baseline|Total|Total of all reporting groups
842220|NCT01257230|B3|Baseline|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842221|NCT01257230|B2|Baseline|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842222|NCT01257230|B1|Baseline|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842223|NCT01257230|P3|Participant Flow|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler.
842224|NCT01257230|P2|Participant Flow|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842225|NCT01257230|P1|Participant Flow|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842226|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842227|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842228|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842229|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842230|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842231|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842232|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842233|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842234|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842235|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842236|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842237|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842238|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842239|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842240|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842241|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842242|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842243|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842244|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842245|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842246|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842247|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842248|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842249|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842250|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842251|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842252|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842253|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842254|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842255|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842256|NCT01257230|O3|Outcome|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842257|NCT01257230|O2|Outcome|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks delivered by the Respimat Inhaler
846885|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
842273|NCT01257230|O1|Outcome|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842274|NCT01257230|E3|Reported Event|Tio R5|Inhalation of 5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842275|NCT01257230|E2|Reported Event|Tio R2.5|Inhalation of 2.5μg tiotropium bromide solution once daily for 48 weeks, delivered by the Respimat Inhaler
842276|NCT01257230|E1|Reported Event|Placebo Respimat|Inhalation of placebo solution once daily for 48 weeks, delivered by the Respimat Inhaler
842277|NCT01257217|B3|Baseline|Total|Total of all reporting groups
842278|NCT01257217|B2|Baseline|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
842279|NCT01257217|B1|Baseline|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
842280|NCT01257217|P2|Participant Flow|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
842281|NCT01257217|P1|Participant Flow|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
842282|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
842283|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
842284|NCT01257217|O4|Outcome|Acri.LISA/With|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
842285|NCT01257217|O3|Outcome|Acri.LISA/Without|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
842286|NCT01257217|O2|Outcome|ReSTOR +3/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids
842287|NCT01257217|O1|Outcome|ReSTOR +3/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
842288|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
842289|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
842290|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
842291|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
842292|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
842293|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
842294|NCT01257217|O2|Outcome|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL, lens assignment determined by preoperative keratometric astigmatism, bilateral implantation
842295|NCT01257217|O1|Outcome|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT, lens assignment and model determined by preoperative keratometric astigmatism, bilateral implantation
842296|NCT01257217|E2|Reported Event|Acri.LISA|Acri.LISA® 366D IOL or Acri.LISA® 466TD Toric IOL
842297|NCT01257217|E1|Reported Event|ReSTOR +3|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1 or AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL
842298|NCT01257204|B4|Baseline|Total|Total of all reporting groups
842299|NCT01257204|B3|Baseline|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842300|NCT01257204|B2|Baseline|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842301|NCT01257204|B1|Baseline|Dacalatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842302|NCT01257204|P3|Participant Flow|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
842303|NCT01257204|P2|Participant Flow|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
842304|NCT01257204|P1|Participant Flow|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα­2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
842470|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
842305|NCT01257204|O3|Outcome|Placebo: Follow-up|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks during treatment period and entered into the follow-up period.
842306|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks during treatment period and entered into the follow-up period.
842307|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
842308|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842309|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842310|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842311|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842312|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842313|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842314|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842315|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842316|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842317|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 mcg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842318|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842319|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842320|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842321|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842322|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842323|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842324|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842325|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842326|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842327|NCT01257204|O2|Outcome|Dacalatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842328|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842524|NCT01256164|B3|Baseline|Total|Total of all reporting groups
842329|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842330|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842331|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842332|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842333|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842334|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 week s.
842335|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842336|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842337|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842338|NCT01257204|O3|Outcome|Placebo|Participants received placebo matching with daclatasvir tablets orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 24 weeks.
842339|NCT01257204|O2|Outcome|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα­2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 16 weeks.
842340|NCT01257204|O1|Outcome|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks.
842341|NCT01257204|E6|Reported Event|Placebo: Follow-up|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks during treatment period and entered into the follow-up period.
842342|NCT01257204|E5|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks during treatment period and entered into the follow-up period.
842343|NCT01257204|E4|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort: Follow-up|Participants received daclatasvir tablets 60 mg orally, once daily, along with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, up to 12 weeks during treatment period and entered into the follow-up period.
842344|NCT01257204|E3|Reported Event|Placebo|Participants received placebo matched with daclatasvir tablets orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 24 weeks.
842345|NCT01257204|E2|Reported Event|Daclatasvir, 60 mg, 16-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 16 weeks.
842346|NCT01257204|E1|Reported Event|Daclatasvir, 60 mg, 12-Week Cohort|Participants received daclatasvir tablets 60 mg orally, once daily, with pegylated-interferon alfa-2a (pegIFNα-2a) solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 400 mg orally, twice daily, for up to 12 weeks.
842347|NCT01256450|B3|Baseline|Total|Total of all reporting groups
842348|NCT01256450|B2|Baseline|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842349|NCT01256450|B1|Baseline|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842350|NCT01256450|P3|Participant Flow|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842351|NCT01256450|P2|Participant Flow|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842352|NCT01256450|P1|Participant Flow|OL Buprenorphine HCl Buccal Film|Buprenorphine hydrochloride (HCl) buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
842353|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842354|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842355|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
846886|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
842356|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842357|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842358|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842359|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842360|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842361|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842362|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842363|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842364|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842365|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842366|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842367|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842368|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842369|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842370|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842371|NCT01256450|O2|Outcome|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842372|NCT01256450|O1|Outcome|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind treatment period
842373|NCT01256450|E3|Reported Event|DB Placebo Film|Placebo buccal film applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
842374|NCT01256450|E2|Reported Event|DB Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for 12 weeks in the double-blind period
842375|NCT01256450|E1|Reported Event|OL Buprenorphine HCl Buccal Film|Buprenorphine HCl buccal film, 60, 120, 180, or 240 µg, applied to the buccal mucosa every 12 hours for up to 4 weeks in the open-label titration period
842376|NCT01256424|B5|Baseline|Total|Total of all reporting groups
842377|NCT01256424|B4|Baseline|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
842378|NCT01256424|B3|Baseline|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
842379|NCT01256424|B2|Baseline|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
842380|NCT01256424|B1|Baseline|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
842381|NCT01256424|P4|Participant Flow|Placebo Ointment Without Illumination|Treatment with a singe dose of 2g placebo ointment, no photoactivation
842382|NCT01256424|P3|Participant Flow|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
842383|NCT01256424|P2|Participant Flow|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
842384|NCT01256424|P1|Participant Flow|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
842385|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
842386|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
842387|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
842388|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
842389|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
842390|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
842391|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
842392|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
842393|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment,no photoactivation
842394|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
842395|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
842396|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
842397|NCT01256424|O4|Outcome|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
842398|NCT01256424|O3|Outcome|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
842399|NCT01256424|O2|Outcome|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
842400|NCT01256424|O1|Outcome|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
842401|NCT01256424|E4|Reported Event|Placebo Ointment Without Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g placebo ointment, no photoactivation
842402|NCT01256424|E3|Reported Event|HAL 0.2% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 0.2% ointment followed by photoactivation
842403|NCT01256424|E2|Reported Event|HAL 1% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 1% ointment followed by photoactivation
842404|NCT01256424|E1|Reported Event|HAL 5% With Illumination|Cervical PDT using Hexaminolevulinate: Treatment with a singe dose of 2g HAL 5% ointment followed by photoactivation
842405|NCT01256411|B5|Baseline|Total|Total of all reporting groups
842406|NCT01256411|B4|Baseline|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
842407|NCT01256411|B3|Baseline|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
842408|NCT01256411|B2|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
842409|NCT01256411|B1|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
842410|NCT01256411|P6|Participant Flow|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
842411|NCT01256411|P5|Participant Flow|LCZ696 Monotherapy|Participants received LCZ696 only.
842412|NCT01256411|P4|Participant Flow|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
842413|NCT01256411|P3|Participant Flow|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
842414|NCT01256411|P2|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
842415|NCT01256411|P1|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
842416|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
842417|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
842418|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
842419|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
842420|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
842421|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
842422|NCT01256411|O2|Outcome|LCZ696 Combination Therapy|Participants received LCZ696 with amlodipine and/or HCTZ.
842423|NCT01256411|O1|Outcome|LCZ696 Monotherapy|Participants received LCZ696 only.
842424|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
842425|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
842426|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
842427|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
842428|NCT01256411|O5|Outcome|LCZ696 100 mg|Participants were down-titrated to 100 mg.
842429|NCT01256411|O4|Outcome|LCZ696 400 mg/Amlodipine/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
842430|NCT01256411|O3|Outcome|LCZ606 400 mg/Amlodipine|Participants received LCZ696 400 mg by mouth qd and amlodipine 5mg up to 10 mg by mouth as needed (prn).
842431|NCT01256411|O2|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
842432|NCT01256411|O1|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
842433|NCT01256411|E5|Reported Event|LCZ696 400 mg/Aml/HCTZ|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
842434|NCT01256411|E4|Reported Event|LCZ696 400 mg/Aml|Participants received LCZ696 400 mg by mouth qd, amlodipine 5 mg up to 10 mg by mouth prn and HCTZ 6.25 mg and up to 25 mg by mouth prn.
842435|NCT01256411|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg by mouth qd.
842436|NCT01256411|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg by mouth once daily (qd).
842437|NCT01256411|E1|Reported Event|LCZ696 100 mg|Participants were down-titrated to 100 mg.
842438|NCT01256385|B3|Baseline|Total|Total of all reporting groups
842466|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
842439|NCT01256385|B2|Baseline|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842440|NCT01256385|B1|Baseline|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842441|NCT01256385|P2|Participant Flow|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842442|NCT01256385|P1|Participant Flow|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842443|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842444|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842445|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842446|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842447|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842448|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842449|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842450|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842451|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842452|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842453|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842454|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842455|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842456|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842457|NCT01256385|O2|Outcome|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842458|NCT01256385|O1|Outcome|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842459|NCT01256385|E2|Reported Event|Arm B (Temsirolimus)|Patients receive temsirolimus as in Arm A. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients with progressive disease may cross over to Arm A.
842460|NCT01256385|E1|Reported Event|Arm A (Cetuximab and Temsirolimus)|Patients receive temsirolimus IV over 30-60 minutes and cetuximab IV over 1-2 hours once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
842461|NCT01256294|B1|Baseline|All Participants|"Period 1 (Days 1 through 14): Participants randomized to Sequence 1 took branded tacrolimus (Prograf) and participants randomized to Sequence 2 took generic tacrolimus (Sandoz).~Period 2 (Days 15 through 28): Participants randomized to Sequence 1 crossed over to treatment with generic tacrolimus and participants randomized to Sequence 2 crossed over to treatment with branded tacrolimus."
842462|NCT01256294|P2|Participant Flow|Sequence 2 - Generic Tacrolimus / Branded Tacrolimus|In Period 1 (Days 1-14) participants received generic tacrolimus (Sandoz) orally twice a day and in Period 2 (Days 15-28) participants received branded tacrolimus (Prograf) orally twice a day. Participants received the same stable dosage of tacrolimus dose they had been taking prior to enrollment (on a milligram for milligram basis).
842463|NCT01256294|P1|Participant Flow|Sequence 1 - Branded Tacrolimus / Generic Tacrolimus|In Period 1 (Days 1 - 14) participants received branded tacrolimus (Prograf) orally twice a day and in Period 2 (Days 15 - 28) participants received generic tacrolimus (Sandoz) orally twice a day. Participants received the same stable dosage of tacrolimus they had been taking prior to enrollment (on a milligram for milligram basis).
842464|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
842465|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
845014|NCT01249274|O1|Outcome|Placebo|Placebo: Matched placebo pills to be taken twice daily
842467|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
842468|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
842469|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
846887|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
842471|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
842472|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
842473|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
842474|NCT01256294|O2|Outcome|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
842475|NCT01256294|O1|Outcome|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
842476|NCT01256294|E2|Reported Event|Branded Tacrolimus|Participants received branded tacrolimus (Prograf) orally twice a day for 14 days.
842477|NCT01256294|E1|Reported Event|Generic Tacrolimus|Participants received generic tacrolimus (Sandoz) orally twice a day for 14 days.
842478|NCT01256281|B1|Baseline|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
842479|NCT01256281|P1|Participant Flow|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
842480|NCT01256281|O1|Outcome|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
842481|NCT01256281|E1|Reported Event|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
842482|NCT01256190|B3|Baseline|Total|Total of all reporting groups
842483|NCT01256190|B2|Baseline|Gelatin Sponge|approved device for surgical bleeding
842484|NCT01256190|B1|Baseline|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842485|NCT01256190|P2|Participant Flow|Gelatin Sponge|approved device for surgical bleeding
842486|NCT01256190|P1|Participant Flow|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842487|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
842488|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842489|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
842490|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842491|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
842492|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842493|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
842494|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842495|NCT01256190|O2|Outcome|Gelatin Sponge|approved device for surgical bleeding
842496|NCT01256190|O1|Outcome|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842497|NCT01256190|E2|Reported Event|Gelatin Sponge|approved device for surgical bleeding
842498|NCT01256190|E1|Reported Event|Fibrocaps + Gelatin Sponge|Topical Fibrocaps powder followed by application of gelatin sponge
842499|NCT01256177|B3|Baseline|Total|Total of all reporting groups
842500|NCT01256177|B2|Baseline|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842501|NCT01256177|B1|Baseline|Placebo|Placebo matching Quetiapine XR.
842502|NCT01256177|P2|Participant Flow|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842503|NCT01256177|P1|Participant Flow|Placebo|Placebo matching Quetiapine XR.
842504|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842505|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842506|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842507|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842508|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842509|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842510|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842511|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842512|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842513|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842514|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842515|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842516|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842517|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842518|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842519|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842520|NCT01256177|O2|Outcome|Quetiapine XR|Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening.
842521|NCT01256177|O1|Outcome|Placebo|Placebo matching Quetiapine XR.
842522|NCT01256177|E2|Reported Event|QUETIAPINE XR|
842523|NCT01256177|E1|Reported Event|PLACEBO|
842525|NCT01256164|B2|Baseline|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842526|NCT01256164|B1|Baseline|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842527|NCT01256164|P2|Participant Flow|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842528|NCT01256164|P1|Participant Flow|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842529|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842530|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842531|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842532|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842533|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842534|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842535|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842536|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842537|NCT01256164|O2|Outcome|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842538|NCT01256164|O1|Outcome|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842539|NCT01256164|E2|Reported Event|Gelfoam|Treatment will be Gelfoam followed by manual pressure with sterile gauze. If hemostasis has not been achieved within 10 minutes of the Start Time,the subject will be considered a treatment failure and the surgeon will implement additional hemostatic measures.
842540|NCT01256164|E1|Reported Event|Fibrocaps + Gelfoam|After identification of a Target Bleeding Site (TBS), topical Fibrocaps powder will be applied using the Fibrospray device for general surgeries; and either the Fibrospray device or direct application for spinal and vascular surgeries, followed by application of Gelfoam and manual pressure with sterile gauze.
842541|NCT01256086|B5|Baseline|Total|Total of all reporting groups
842542|NCT01256086|B4|Baseline|A2N2N1A1|Sequence 4: A2N2N1A1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
842543|NCT01256086|B3|Baseline|N2A1A2N1|Sequence 3: N2A1A2N1 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
842544|NCT01256086|B2|Baseline|A1N1N2A2|Sequence 2: A1N1N2A2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
842545|NCT01256086|B1|Baseline|N1A2A1N2|Sequence 1: N1A2A1N2 (Treatment day 1 to treatment day 4) N1 = 12µg Novolizer N2 = 24µg Novolizer A1 = 12µg Aerolizer A2 = 24µg Aerolizer
842546|NCT01256086|P4|Participant Flow|A2N2N1A1|Treatment sequence 24 µg Aerolizer - 24 µg Novolizer - 12 µg Novolizer - 12 µg Aerolizer
842547|NCT01256086|P3|Participant Flow|N2A1A2N1|Treatment sequence 24 µg Novolizer - 12 µg Aerolizer - 24 µg Aerolizer - 12 µg Novolizer
842548|NCT01256086|P2|Participant Flow|A1N1N2A2|Treatment sequence 12 µg Aerolizer - 12 µg Novolizer - 24 µg Novolizer - 24 µg Aerolizer
842549|NCT01256086|P1|Participant Flow|N1A2A1N2|Treatment sequence 12 µg Novolizer - 24 µg Aerolizer - 12 µg Aerolizer - 24 µg Novolizer
842550|NCT01256086|O4|Outcome|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
842551|NCT01256086|O3|Outcome|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
842552|NCT01256086|O2|Outcome|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
846888|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
842553|NCT01256086|O1|Outcome|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
842554|NCT01256086|E4|Reported Event|12µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
842555|NCT01256086|E3|Reported Event|24 µg Formoterol Aerolizer|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
842556|NCT01256086|E2|Reported Event|12µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
842557|NCT01256086|E1|Reported Event|24 µg Formoterol Novolizer|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
842558|NCT01256060|B1|Baseline|Intanasal Oxytocin|"A modified dose finding method was used to determine safety among four dose levels. Half the dose (0.2 IU/kg /dose) was the minimum dose and two intermediate doses were also evaluated (0.26 and 0.33 IU/kg / dose) Dose-finding escalations were done in groups of three patients.~Three patients were studied at the first dose level~If none of these patients experienced dose limiting toxicity, the dose was escalated.~If one patient experienced dose limiting toxicity, up to three more patients were accrued at the same level. (a) If none of these patients experienced dose limiting toxicity, the dose was escalated. (b) If one or more experienced dose-limiting toxicity, entry at that dose level would be stopped, the maximum tolerated dose exceeded, and dose escalation would be stopped. Up to three more patients would be treated at the next lower dose. If zero out of three patients experience dose limiting toxicity, an additional three patients were to be treated at that dose."
842559|NCT01256060|P4|Participant Flow|0.4 IU / kg|
842560|NCT01256060|P3|Participant Flow|0.33 IU / kg|
842561|NCT01256060|P2|Participant Flow|0.26 IU / kg|
842562|NCT01256060|P1|Participant Flow|0.2 IU / kg|
842563|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
842564|NCT01256060|O1|Outcome|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin
842565|NCT01256060|O1|Outcome|Intanasal Oxytocin|Number of Participants Experiencing a Serious Adverse Event
842566|NCT01256060|O1|Outcome|Intanasal Oxytocin|Cohort 1 Dosage: 0.20 IU/kg - 3 participants Cohort 2 Dosage: 0.26 IU/kg - 3 participants Cohort 3 Dosage: 0.33 IU/kg - 3 participants Cohort 4 Dosage: 0.40 IU/kg - 6 participants
842567|NCT01256060|E1|Reported Event|Intranasal Oxytocin|Oxytocin: Intranasal Oxytocin. Please note that the Adverse Events are not presented per dose level received, as this is not a dose-finding study, it is a modified maximum tolerated dose study. This means that a small number of participants were exposed to increasing dose levels to assess for Adverse Events. It is not meaningful to analyze adverse events by cohorts due to the extremely small sample size.
842568|NCT01256034|B3|Baseline|Total|Total of all reporting groups
842569|NCT01256034|B2|Baseline|Group B|ordinary diet
842570|NCT01256034|B1|Baseline|Group A|preoperative immunonutrition
842571|NCT01256034|P2|Participant Flow|Group B|ordinary diet
842572|NCT01256034|P1|Participant Flow|Group A|preoperative immunonutrition
842573|NCT01256034|O2|Outcome|Group B|ordinary diet
842574|NCT01256034|O1|Outcome|Group A|preoperative immunonutrition
842575|NCT01256034|E2|Reported Event|Group B|ordinary diet
842576|NCT01256034|E1|Reported Event|Group A|preoperative immunonutrition
842577|NCT01256008|B4|Baseline|Total|Total of all reporting groups
842578|NCT01256008|B3|Baseline|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842579|NCT01256008|B2|Baseline|stage1 CBT|"The experimental group each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
842580|NCT01256008|B1|Baseline|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842581|NCT01256008|P3|Participant Flow|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842582|NCT01256008|P2|Participant Flow|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
845630|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
842623|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842624|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842625|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842583|NCT01256008|P1|Participant Flow|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842584|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842585|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
842586|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842587|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842588|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
842589|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842590|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842591|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
842592|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842593|NCT01256008|O3|Outcome|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842594|NCT01256008|O2|Outcome|stage1 CBT|"The experimental group will receive CBT each session.~CBT: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
842621|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842622|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842595|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842596|NCT01256008|O3|Outcome|Stage 1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842597|NCT01256008|O2|Outcome|Stage 1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
842598|NCT01256008|O1|Outcome|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842599|NCT01256008|E3|Reported Event|stage1 Control Group|Participants with breast cancer in the control group received standard medical care, but don't receive any other interventions.
842600|NCT01256008|E2|Reported Event|stage1 CBT|"The experimental group will receive CBT each session.~CBT and clinical management: The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention."
842601|NCT01256008|E1|Reported Event|Stage 1 Clinical Management|"The group will receive clinical management treatment only each session.~Clinical Management: Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.~Following are major elements:~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
842602|NCT01255904|B3|Baseline|Total|Total of all reporting groups
842603|NCT01255904|B2|Baseline|Oral Chloral Hydrate and Intranasal Placebo|
842604|NCT01255904|B1|Baseline|Oral Placebo and Intransal Dexmedetomidine|
842605|NCT01255904|P2|Participant Flow|Oral Chloral Hydrate and Intranasal Placebo|50 mg/kg oral chloral hydrate followed by intranasal placebo.
842606|NCT01255904|P1|Participant Flow|Oral Placebo and Intransal Dexmedetomidine|Oral placebo followed by Intranasal dexmedetomidine 3 mcg/kg (max dose 100 mcg).
842607|NCT01255904|O2|Outcome|Oral Chloral Hydrate and Intranasal Placebo|
842608|NCT01255904|O1|Outcome|Oral Placebo and Intransal Dexmedetomidine|
842609|NCT01255904|E2|Reported Event|Oral Chloral Hydrate and Intranasal Placebo|
842610|NCT01255904|E1|Reported Event|Oral Placebo and Intransal Dexmedetomidine|
842611|NCT01255787|B5|Baseline|Total|Total of all reporting groups
842612|NCT01255787|B4|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842613|NCT01255787|B3|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842614|NCT01255787|B2|Baseline|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842615|NCT01255787|B1|Baseline|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842616|NCT01255787|P4|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842617|NCT01255787|P3|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842618|NCT01255787|P2|Participant Flow|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842619|NCT01255787|P1|Participant Flow|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842620|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842626|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842627|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842628|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842629|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842630|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842631|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842632|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842633|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842634|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842635|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842636|NCT01255787|O4|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842637|NCT01255787|O3|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842638|NCT01255787|O2|Outcome|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842639|NCT01255787|O1|Outcome|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842640|NCT01255787|E4|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, tablets, orally, once daily for 1 week, followed by vortioxetine 20 mg, tablets, orally, once daily for 7 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily, for 2 weeks.
842641|NCT01255787|E3|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842642|NCT01255787|E2|Reported Event|Vortioxetine 5 mg|Vortioxetine 5 mg, tablets, orally, once daily for 8 weeks, followed by vortioxetine placebo-matching tablets, orally, once daily for 2 weeks.
842643|NCT01255787|E1|Reported Event|Placebo|Vortioxetine placebo-matching tablets, orally, once daily for up to 10 weeks.
842644|NCT01255761|B3|Baseline|Total|Total of all reporting groups
842645|NCT01255761|B2|Baseline|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842646|NCT01255761|B1|Baseline|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842647|NCT01255761|P2|Participant Flow|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842648|NCT01255761|P1|Participant Flow|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842649|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842650|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842651|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842652|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842653|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842654|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842816|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842655|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842656|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842657|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842658|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842659|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842660|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842661|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842662|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842663|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842664|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842665|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842666|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842667|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842668|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842669|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842670|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842671|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842672|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842673|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842674|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842675|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842676|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842677|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842678|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842679|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842680|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842681|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842682|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842683|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842684|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842685|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842686|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842687|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842688|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842689|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842690|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842691|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842692|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842693|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842694|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842695|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842696|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842697|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842698|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842699|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842700|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842701|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842702|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842703|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842704|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842705|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842706|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842707|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842708|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842709|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842710|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842711|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842712|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842713|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842714|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842715|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842716|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842717|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842718|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842719|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842720|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842721|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842722|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842723|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842724|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842725|NCT01255761|O2|Outcome|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842726|NCT01255761|O1|Outcome|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842727|NCT01255761|E2|Reported Event|CDAI to Assess Response to Cimzia|"CDAI is an investigator-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a clinical measures tool, a tool based on Investigator measures without the need for a lab value (CDAI)"
842728|NCT01255761|E1|Reported Event|RAPID3 to Assess Response to Cimzia|"RAPID3 is a subject-based assessment tool used to assess subject's response to Cimzia.~Subjects will be randomized to a patient measure tool, a tool based on patient-report outcomes (RAPID3); using a total score of 30 points"
842729|NCT01255722|B4|Baseline|Total|Total of all reporting groups
842730|NCT01255722|B3|Baseline|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842817|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842731|NCT01255722|B2|Baseline|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
842732|NCT01255722|B1|Baseline|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842733|NCT01255722|P3|Participant Flow|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842734|NCT01255722|P2|Participant Flow|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
842735|NCT01255722|P1|Participant Flow|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842736|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842737|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
842738|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842739|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842740|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
842741|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842742|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842743|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
842744|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842745|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842746|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
842747|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842748|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842749|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before coronary CT angiography
842750|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842751|NCT01255722|O3|Outcome|Iomeprol|Patients were IV injected with a single dose of iomeprol before a coronary CT angiography
842752|NCT01255722|O2|Outcome|Iopromide|Patients were IV injected with a single dose of iopromide before a coronary CT angiography
842753|NCT01255722|O1|Outcome|Iobitridol|Patients were IV injected with a single dose of iobitridol before a coronary CT angiography
842754|NCT01255722|E3|Reported Event|Iomeprol|"Patients were IV injected with a single dose of iomeprol before a coronary CT angiography~iomeprol: Single IV injection"
842755|NCT01255722|E2|Reported Event|Iopromide|"Patients were IV injected with a single dose of iopromide before a coronary CT angiography~iopromide: Single IV injection"
842756|NCT01255722|E1|Reported Event|Iobitridol|"Patients were IV injected with a single dose of iobitridol before a coronary CT angiography~iobitridol: single IV injection"
842757|NCT01255631|B3|Baseline|Total|Total of all reporting groups
842758|NCT01255631|B2|Baseline|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842759|NCT01255631|B1|Baseline|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842760|NCT01255631|P2|Participant Flow|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842761|NCT01255631|P1|Participant Flow|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842762|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842763|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842764|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842765|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842818|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842835|NCT01255449|B1|Baseline|Albuterol|All recruited subjects underwent an acute bronchodilation with albuterol following baseline pulmonary function measurements.
842836|NCT01255449|P1|Participant Flow|Albuterol|On each study day, all lung function measurements were taken before and 30 min after inhaling four consecutive albuterol doses of 100 mcg each, through a valved-holding chamber. Lung diffusing capacity for carbon monoxide was measured only after bronchodilator inhalation.
846889|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
842766|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842767|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842768|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842769|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842770|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842771|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842772|NCT01255631|O2|Outcome|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842773|NCT01255631|O1|Outcome|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842774|NCT01255631|E2|Reported Event|PEMF Device|"PEMF Device: The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
842775|NCT01255631|E1|Reported Event|Sham PEMF Device|Sham PEMF Device: Inactive PEMF device, delivers no PMF
842776|NCT01255592|B3|Baseline|Total|Total of all reporting groups
842777|NCT01255592|B2|Baseline|Placebo|Placebo bd
842778|NCT01255592|B1|Baseline|AZD5069|AZD5069 80 mg bd
842779|NCT01255592|P2|Participant Flow|Placebo|Placebo for AZD5069, bd
842780|NCT01255592|P1|Participant Flow|AZD5069|AZD5069 80 mg bd
842781|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842782|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842783|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842784|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842785|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842786|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842787|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842788|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842789|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842790|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842791|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842792|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842793|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842794|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842795|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842796|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842797|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842798|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842799|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842800|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842801|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842802|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842803|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842804|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842805|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842806|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842807|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842808|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842809|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842810|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842811|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842812|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842813|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842814|NCT01255592|O1|Outcome|AZD5069|AZD5069 80 mg bd
842815|NCT01255592|O2|Outcome|Placebo|Placebo for AZD5069, bd
842837|NCT01255449|O1|Outcome|Post-HSCT Changes in Lung Tissue Density|In eight out of 26 patients, a quantitative CT scan analysis was conducted to measure changes in lung tissue density
842838|NCT01255449|O1|Outcome|Airway Distensibility With Lung Inflation After HSCT|Changes in airway conductance at 5 Hz (Grs5) were related to changes in lung volume (DeltaGrs5/DeltaVL) to estimate airway distensibility
842839|NCT01255449|E1|Reported Event|Albuterol|All subjects underwent an acute bronchodilation with albuterol by inhaling four consecutive doses (100 mcg each)of the drug through a valved-holding chamber
842840|NCT01255436|B3|Baseline|Total|Total of all reporting groups
842841|NCT01255436|B2|Baseline|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
842842|NCT01255436|B1|Baseline|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
842843|NCT01255436|P2|Participant Flow|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
842844|NCT01255436|P1|Participant Flow|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
842845|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
842846|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
842847|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
842848|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
842849|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
842850|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
842851|NCT01255436|O2|Outcome|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
842852|NCT01255436|O1|Outcome|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
842853|NCT01255436|E2|Reported Event|No SMS Text Reminders|Usual care consisting of clinic visits, physician advice and medication prescriptions
842854|NCT01255436|E1|Reported Event|SMS Text Reminders|2 SMS text reminders per week for 12 weeks
842855|NCT01255423|B3|Baseline|Total|Total of all reporting groups
842856|NCT01255423|B2|Baseline|Placebo|
842857|NCT01255423|B1|Baseline|Diclofenac Sodium Topical Gel 1%|
842858|NCT01255423|P2|Participant Flow|Placebo|
842859|NCT01255423|P1|Participant Flow|Diclofenac Sodium Topical Gel 1%|
842860|NCT01255423|O2|Outcome|Placebo|
842861|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
842862|NCT01255423|O2|Outcome|Placebo|
842863|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
842864|NCT01255423|O2|Outcome|Placebo|
842865|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
842866|NCT01255423|O2|Outcome|Placebo|
842867|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
842868|NCT01255423|O2|Outcome|Placebo|
842869|NCT01255423|O1|Outcome|Diclofenac Sodium Topical Gel 1%|
842870|NCT01255423|E2|Reported Event|Placebo|
842871|NCT01255423|E1|Reported Event|Diclofenac Sodium Topical Gel 1%|
842872|NCT01255306|B3|Baseline|Total|Total of all reporting groups
842873|NCT01255306|B2|Baseline|RAISED IOP|Patients with raised IOP
842874|NCT01255306|B1|Baseline|NO IOP|Patients without raised IOP
842875|NCT01255306|P2|Participant Flow|RAISED IOP|Patients with raised IOP
842876|NCT01255306|P1|Participant Flow|NO IOP|Patients without raised IOP
842877|NCT01255306|O3|Outcome|CONTROL|Fellow eye of each patient
842878|NCT01255306|O2|Outcome|RAISED IOP|Patients with raised IOP
842879|NCT01255306|O1|Outcome|NO IOP|Patients without raised IOP
842880|NCT01255306|O2|Outcome|CONTROL EYES|Fellow eye of each patient
842881|NCT01255306|O1|Outcome|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
842882|NCT01255306|E2|Reported Event|CONTROL EYES|Fellow eye of each patient
842883|NCT01255306|E1|Reported Event|STUDY EYES|Study eyes that underwent pars plana vitrectomy and silicone oil tamponade
842884|NCT01255137|B1|Baseline|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
842885|NCT01255137|P1|Participant Flow|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
842886|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
842887|NCT01255137|O1|Outcome|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
842888|NCT01255137|E1|Reported Event|Adrenal Cortex Neoplasms|"Aggressive cancer that starts in the adrenal gland located at the top of the kidneys.~Axitinib : 5 mg tab orally twice a day with food every 28 days"
842889|NCT01254890|B3|Baseline|Total|Total of all reporting groups
842890|NCT01254890|B2|Baseline|Phase II: Azacitidine + 400 Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
842891|NCT01254890|B1|Baseline|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
842892|NCT01254890|P2|Participant Flow|Phase II: Azacitidine + 400 mg Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib 400 mg orally twice a day for 28 Day cycle.
842893|NCT01254890|P1|Participant Flow|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
842894|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
846890|NCT01242514|E3|Reported Event|FOSTA 150 MG QD|
842895|NCT01254890|O1|Outcome|Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
842896|NCT01254890|E2|Reported Event|Phase II: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 400 mg orally twice a day for 28 Day cycle.
842897|NCT01254890|E1|Reported Event|Phase I: Azacitidine + Sorafenib|Azacitidine (AZA) 75 mg/m^2 subcutaneously (SQ) or intravenously (IV) daily for 7 days and Sorafenib starting dose 200 mg orally twice a day for 28 Day cycle.
842898|NCT01254851|B3|Baseline|Total|Total of all reporting groups
842899|NCT01254851|B2|Baseline|Usual Care|routine post-operative ambulation
842900|NCT01254851|B1|Baseline|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
842901|NCT01254851|P2|Participant Flow|Usual Care|routine post-operative ambulation
842902|NCT01254851|P1|Participant Flow|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
842903|NCT01254851|O2|Outcome|Usual Care|routine post-operative ambulation
842904|NCT01254851|O1|Outcome|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
842905|NCT01254851|E2|Reported Event|Usual Care|routine post-operative ambulation
842906|NCT01254851|E1|Reported Event|Goal-augmented Post-operative Care.|Patients in this group will be given a goal number of steps to take on each post-operative day.
842907|NCT01254760|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
842908|NCT01254760|P2|Participant Flow|Commercial Multifocal / Investigational Multifocal|Commercial multifocal contact lenses worn first, with investigational multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
842909|NCT01254760|P1|Participant Flow|Investigational Multifocal / Commercial Multifocal|Investigational multifocal contact lenses worn first, with commercial multifocal contact lenses worn second. Each product worn bilaterally on a daily wear, daily disposable basis for 5 days.
842910|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842911|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842912|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in bilaterally on a daily wear, daily disposable basis for 5 days
842913|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842914|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842915|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842916|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842917|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842918|NCT01254760|O2|Outcome|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842919|NCT01254760|O1|Outcome|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn bilaterally on a daily wear, daily disposable basis for 5 days
842920|NCT01254760|E2|Reported Event|Nelfilcon A Commercial|Nelfilcon A commercial contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
842921|NCT01254760|E1|Reported Event|Nelfilcon A Investigational|Nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for 5 days
842922|NCT01254747|B5|Baseline|Total|Total of all reporting groups
842923|NCT01254747|B4|Baseline|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842924|NCT01254747|B3|Baseline|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842925|NCT01254747|B2|Baseline|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842926|NCT01254747|B1|Baseline|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842927|NCT01254747|P4|Participant Flow|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842928|NCT01254747|P3|Participant Flow|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842929|NCT01254747|P2|Participant Flow|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842930|NCT01254747|P1|Participant Flow|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842931|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842932|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842933|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842934|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842935|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
846696|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
842936|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842937|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
843107|NCT01254409|B2|Baseline|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
842938|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842939|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842940|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842941|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842942|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842943|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842944|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842945|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842946|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842947|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842948|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842949|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842950|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842951|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842952|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842953|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842954|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842955|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842956|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842957|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842958|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842959|NCT01254747|O4|Outcome|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842960|NCT01254747|O3|Outcome|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842961|NCT01254747|O2|Outcome|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842962|NCT01254747|O1|Outcome|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842963|NCT01254747|E4|Reported Event|Narafilcon A|Narafilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842964|NCT01254747|E3|Reported Event|Nelfilcon A|Nelfilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842965|NCT01254747|E2|Reported Event|Lotrafilcon B|Lotrafilcon B contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842966|NCT01254747|E1|Reported Event|Delefilcon A|Delefilcon A contact lenses worn in both eyes on a daily wear, daily disposable basis for four weeks.
842967|NCT01254721|B3|Baseline|Total|Total of all reporting groups
842968|NCT01254721|B2|Baseline|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
842969|NCT01254721|B1|Baseline|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
842970|NCT01254721|P2|Participant Flow|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
842971|NCT01254721|P1|Participant Flow|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
842972|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
842973|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
842974|NCT01254721|O2|Outcome|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
842975|NCT01254721|O1|Outcome|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
842996|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
842997|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
846891|NCT01242514|E2|Reported Event|FOSTA 100 MG QD|
842976|NCT01254721|E2|Reported Event|Seroquel XR + Lithium|"Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].~Treatment duration: 28 days"
842977|NCT01254721|E1|Reported Event|Seroquel XR|"Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.~Treatment duration: 28 days"
842978|NCT01254669|B3|Baseline|Total|Total of all reporting groups
842979|NCT01254669|B2|Baseline|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one for immigration status .
842980|NCT01254669|B1|Baseline|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
842981|NCT01254669|P2|Participant Flow|Brief Negotiated Inteview (BNI) Intervention|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~One hundred mothers received intervention (n=50 Haitian, 50 African-American). Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2) and one dropped out for fear information from study will affect her immigration status"
842982|NCT01254669|P1|Participant Flow|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve Human Papilloma Virus (HPV) vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Mothers assigned to the Control Group received the low-literacy, standard-practice, HPV vaccine information sheet usually given to all patients prior to vaccination. Control mothers met once with the research assistant to collect demographic characteristics, HPV knowledge, and vaccine status of the daughter on the day of visit. No Brief Negotiated Intervention (BNI) counseling was provided."
842983|NCT01254669|O2|Outcome|Control Group|Did not receive any BNI intervention on the pre and post measure
842984|NCT01254669|O1|Outcome|BNI Post-educational Intervention Group|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Post-educational interventional assessment of HPV knowledge ranges from 0(minimal knowledge) to 12 (maximal knowledge)"
842985|NCT01254669|O2|Outcome|BNI/Intervention|Intervention was administered to 100 African-American and Haitian mothers over 10-20 minutes prior to seeing the health provider if the daughter had never received the HPV vaccine, or after seeing the health provider if the daughter did not received the vaccine during the visit.
842986|NCT01254669|O1|Outcome|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), received the standard of care handout given to patients on the vaccine they will be getting that day. three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
842987|NCT01254669|E2|Reported Event|BNI/Intervention|One hundred mothers received intervention (n=50 Haitian, 50 African-American). . Four Haitian mothers did not receive intervention because (i) One was called to see the clinical provider during the intervention and did not return (n=1), and (ii) time constraints (n=2), one due to fear of information affecting immigration status.
842988|NCT01254669|E1|Reported Event|Standard of Care|"A clinical Pilot trials of a Brief Negotiated Intervention (a brief modified version of Motivational interview using a client-centered style) with mothers to improve HPV vaccination in Haitian and African-American adolescent daughters/girls compare to standard of care.~Of the 100 women in the Control Group (n=50 Haitian, 50 African-American), three African-American mothers did not complete Control Group activities because they did not complete the survey. Reasons for initial dropout/decline to participate included being too busy, not interested, time constraints, and daughter not sexually active upon hearing study has to do with HPV vaccine."
842989|NCT01254656|B4|Baseline|Total|Total of all reporting groups
842990|NCT01254656|B3|Baseline|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
842991|NCT01254656|B2|Baseline|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
842992|NCT01254656|B1|Baseline|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
842993|NCT01254656|P3|Participant Flow|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
842994|NCT01254656|P2|Participant Flow|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
842995|NCT01254656|P1|Participant Flow|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843105|NCT01254409|B4|Baseline|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
842998|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
842999|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843000|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843001|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843002|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843003|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843004|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843005|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843006|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843007|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843008|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843009|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843010|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843011|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843012|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843013|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843014|NCT01254656|O3|Outcome|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843015|NCT01254656|O2|Outcome|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843016|NCT01254656|O1|Outcome|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843017|NCT01254656|E3|Reported Event|Efavirenz (EFV) 600 mg|Participants received EFV 600 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843018|NCT01254656|E2|Reported Event|LRV 750 mg|Participants received LRV 750 mg orally QD. In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843019|NCT01254656|E1|Reported Event|Lersivirine (LRV) 500 mg|Participants received LRV 500 mg orally once daily (QD). In addition participants received treatment with tenofovir disoproxil fumarate (TDF) 300 mg/emtricitabine (FTC) 200 mg orally QD
843020|NCT01254643|B1|Baseline|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843021|NCT01254643|P1|Participant Flow|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine (V503), 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843022|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843023|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843024|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843025|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843026|NCT01254643|O1|Outcome|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843027|NCT01254643|E1|Reported Event|All Enrolled|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6.
843028|NCT01254604|B3|Baseline|Total|Total of all reporting groups
843029|NCT01254604|B2|Baseline|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
843030|NCT01254604|B1|Baseline|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
843031|NCT01254604|P2|Participant Flow|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
846892|NCT01242514|E1|Reported Event|FOSTA 100 MG BID|
843032|NCT01254604|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
843033|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
843034|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
843035|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
843036|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
843037|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
843038|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
843039|NCT01254604|O2|Outcome|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
843040|NCT01254604|O1|Outcome|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
843041|NCT01254604|E2|Reported Event|Timolol|One drop of preservative-free timolol maleate (0.05%) per eye twice daily (morning and evening) for four weeks.
843042|NCT01254604|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle (contains no active drug) per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for four weeks.
843043|NCT01254565|B7|Baseline|Total|Total of all reporting groups
843044|NCT01254565|B6|Baseline|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843045|NCT01254565|B5|Baseline|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843046|NCT01254565|B4|Baseline|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843047|NCT01254565|B3|Baseline|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843048|NCT01254565|B2|Baseline|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843049|NCT01254565|B1|Baseline|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843050|NCT01254565|P6|Participant Flow|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843051|NCT01254565|P5|Participant Flow|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843052|NCT01254565|P4|Participant Flow|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843053|NCT01254565|P3|Participant Flow|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843054|NCT01254565|P2|Participant Flow|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843055|NCT01254565|P1|Participant Flow|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843056|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843057|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843058|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843059|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843060|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843061|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843062|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843063|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843064|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843065|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843066|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843067|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843068|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843069|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843070|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843071|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843072|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843073|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843074|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843075|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843076|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843077|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843078|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843079|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843080|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843081|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843082|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843083|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843084|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843085|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843086|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843087|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843088|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843089|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843090|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843091|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843092|NCT01254565|O6|Outcome|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843093|NCT01254565|O5|Outcome|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843094|NCT01254565|O4|Outcome|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843095|NCT01254565|O3|Outcome|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843096|NCT01254565|O2|Outcome|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843097|NCT01254565|O1|Outcome|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session three times a week (TIW) for 2 weeks.
843098|NCT01254565|E6|Reported Event|Cohort 3: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843099|NCT01254565|E5|Reported Event|Cohort 3: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843100|NCT01254565|E4|Reported Event|Cohort 2: Etelcalcetide 10 mg|Participants received 10 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843101|NCT01254565|E3|Reported Event|Cohort 2: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 4 weeks.
843102|NCT01254565|E2|Reported Event|Cohort 1: Etelcalcetide 5 mg|Participants received 5 mg etelcalcetide administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843103|NCT01254565|E1|Reported Event|Cohort 1: Placebo|Participants received placebo administered by intravenous injection at the end of each hemodialysis session TIW for 2 weeks.
843104|NCT01254409|B5|Baseline|Total|Total of all reporting groups
846771|NCT01243294|E1|Reported Event|SenSura|Base plates applied 1 till 6 times a day
843106|NCT01254409|B3|Baseline|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843108|NCT01254409|B1|Baseline|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843109|NCT01254409|P4|Participant Flow|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843110|NCT01254409|P3|Participant Flow|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843111|NCT01254409|P2|Participant Flow|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843112|NCT01254409|P1|Participant Flow|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843113|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843114|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843115|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843116|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843117|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843118|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843119|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843120|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843121|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843122|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843123|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843124|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843125|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843126|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843127|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843128|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843129|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843130|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843131|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843132|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843133|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843134|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843135|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843136|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843137|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843138|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843139|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843140|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843141|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843142|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843143|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843144|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843145|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843146|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843147|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843148|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843149|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843150|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843151|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843152|NCT01254409|O3|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843153|NCT01254409|O2|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843154|NCT01254409|O1|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843155|NCT01254409|O4|Outcome|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843156|NCT01254409|O3|Outcome|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843157|NCT01254409|O2|Outcome|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843158|NCT01254409|O1|Outcome|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843159|NCT01254409|E4|Reported Event|PRM-151 10 mg/kg|PRM-151 10 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
846893|NCT01242371|B3|Baseline|Total|Total of all reporting groups
843160|NCT01254409|E3|Reported Event|PRM-151 5 mg/kg|PRM-151 5 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843161|NCT01254409|E2|Reported Event|PRM-151 1 mg/kg|PRM-151 1 mg/kg administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843162|NCT01254409|E1|Reported Event|Placebo|0.9% saline administered as a 30 minute IV infusion Days 1, 3, 5, 8 and 15
843163|NCT01254396|B1|Baseline|Entire Study Population|Includes groups randomized to receive sildenafil 50 mg ODT under fasted condition first and sildenafil 50 mg ODT under fed condition first.
843164|NCT01254396|P2|Participant Flow|Sildenafil Fed First, Then Sildenafil Fasted|Single oral dose of sildenafil 50 mg ODT under fed condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fasted condition in second intervention period. A washout period of at least 1 day was maintained between each period.
843165|NCT01254396|P1|Participant Flow|Sildenafil Fasted First, Then Sildenafil Fed|Single oral dose of sildenafil 50 milligram (mg) orally disintegrating tablet (ODT) under fasted condition in first intervention period; and single oral dose of sildenafil 50 mg ODT under fed condition in second intervention period. A washout period of at least 1 day was maintained between each period.
843166|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
843167|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
843168|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
843169|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
843170|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
843171|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
843172|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
843173|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
843174|NCT01254396|O2|Outcome|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
843175|NCT01254396|O1|Outcome|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
843176|NCT01254396|E2|Reported Event|Sildenafil 50 mg (Fed)|Single oral dose of sildenafil 50 mg ODT under fed condition (Test) in either first intervention period or second intervention period.
843177|NCT01254396|E1|Reported Event|Sildenafil 50 mg (Fasted)|Single oral dose of sildenafil 50 mg ODT under fasted condition (Reference) in either first intervention period or second intervention period.
843178|NCT01254344|B3|Baseline|Total|Total of all reporting groups
843179|NCT01254344|B2|Baseline|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
843180|NCT01254344|B1|Baseline|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
843181|NCT01254344|P2|Participant Flow|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
843182|NCT01254344|P1|Participant Flow|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
843183|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
843184|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
843185|NCT01254344|O2|Outcome|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
843186|NCT01254344|O1|Outcome|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
843187|NCT01254344|E2|Reported Event|Ceftriaxone/Metronidazole|Ceftriaxone sodium 2 g administered intravenously (IV) as a single dose followed by metronidazole 500 mg administered IV as a single dose
843188|NCT01254344|E1|Reported Event|Ertapenem|Ertapenem sodium 1 g administered intravenously (IV) as a single dose followed by matching placebo to metronidazole administered IV as a single dose
843189|NCT01254331|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843190|NCT01254331|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the European League Against Rheumatism (EULAR) category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843234|NCT01254292|B1|Baseline|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
846772|NCT01243242|B3|Baseline|Total|Total of all reporting groups
843782|NCT01252810|E2|Reported Event|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration. Up to 7 days post Ioforminol administration.
843191|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843192|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843193|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843194|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843195|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843196|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843197|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843198|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843199|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843200|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843201|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843202|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843203|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843204|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843205|NCT01254331|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843206|NCT01254331|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous infusion once every 4 weeks, for a total of 6 infusions during the initial phase of the study. Participants who completed the initial phase and had at least one moderate response according to the EULAR category entered the extension phase and received an additional 6 infusions of 8 mg/kg tocilizumab every 4 weeks.
843207|NCT01254318|B1|Baseline|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem-cell transplantation.
843208|NCT01254318|P1|Participant Flow|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
843209|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
843210|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
843211|NCT01254318|O1|Outcome|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
843212|NCT01254318|E1|Reported Event|Participants at High Risk for IFI|Participants were considered high risk for IFI if they were undergoing high dose chemotherapy for leukemia. This includes, but is not limited to participants with acute myelogenous leukemia, acute lymphoblastic leukemia, or myelodysplastic syndrome. Participants were also considered to be at high risk for IFI if they had undergone allogeneic hematopoietic stem cell transplantation.
843213|NCT01254305|B4|Baseline|Total|Total of all reporting groups
843214|NCT01254305|B3|Baseline|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
843215|NCT01254305|B2|Baseline|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
843216|NCT01254305|B1|Baseline|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
843217|NCT01254305|P3|Participant Flow|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
843218|NCT01254305|P2|Participant Flow|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration once daily for 8 weeks.
843219|NCT01254305|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing.
843220|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
843221|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks.
843222|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
843223|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
843224|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration once per day for 8 weeks
843225|NCT01254305|O1|Outcome|Placebo|Dose matched placebo capsules, oral administration for 8 weeks.
843226|NCT01254305|O3|Outcome|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
843227|NCT01254305|O2|Outcome|Levomilnacipran ER|40 - 120 mg Levomilnacipran ER capsules, oral administration in capsule form, once daily for 8 weeks
843228|NCT01254305|O1|Outcome|Placebo|Dose matched placebo, oral administration in capsule form, once daily for 8 weeks
843229|NCT01254305|E3|Reported Event|SSRI|"Randomized to treatment with 1 of 4 Selective Serotonin Reuptake Inhibitors (SSRIs) - Paroxetine, Sertraline, Citalopram or Fluoxetine.~Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks."
843230|NCT01254305|E2|Reported Event|Levomilnacipran ER|40 -120 mg Levomilnacipran ER capsules, oral administration, once daily for 8 weeks
843231|NCT01254305|E1|Reported Event|Placebo|"Matching placebo capsules, oral administration~Placebo : Matching placebo capsules, oral administration, once daily dosing"
843232|NCT01254292|B3|Baseline|Total|Total of all reporting groups
843233|NCT01254292|B2|Baseline|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843523|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843235|NCT01254292|P2|Participant Flow|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843236|NCT01254292|P1|Participant Flow|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843237|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843238|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843239|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843240|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843241|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843242|NCT01254292|O1|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843243|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843244|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843245|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843246|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843247|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843248|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843249|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843250|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843251|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843252|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843253|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843254|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843255|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843256|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843257|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843258|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843259|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843260|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843261|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843262|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843524|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843263|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843264|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843265|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843266|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843267|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843268|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843269|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843270|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843271|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843272|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843273|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843274|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843275|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843276|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843277|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843278|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843279|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843280|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843281|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843282|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843283|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843284|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843285|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843286|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843287|NCT01254292|O2|Outcome|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 μg ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles
843288|NCT01254292|O1|Outcome|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 μg LNG per day for 18 months with optional extension to 36 months
843289|NCT01254292|E2|Reported Event|EE30/DRSP (Yasmin, BAY86-5131)|Participants received combined oral contraceptive (COC) tablet Yasmin containing 30 micron ethinyl estradiol (EE) and 3 mg drospirenone (DRSP) for 18 months/19 cycles.
843290|NCT01254292|E1|Reported Event|LCS12 (Skyla, BAY86-5028)|Participants received LCS12 (low dose levonorgestrel [LNG] intrauterine delivery system [IUS]) with an initial in vitro release rate of 12 micron LNG per day for 18 months with optional extension to 36 months.
843291|NCT01254214|B3|Baseline|Total|Total of all reporting groups
843568|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843292|NCT01254214|B2|Baseline|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843293|NCT01254214|B1|Baseline|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843294|NCT01254214|P2|Participant Flow|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843295|NCT01254214|P1|Participant Flow|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843296|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843297|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843298|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843299|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843300|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843301|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843302|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843303|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843304|NCT01254214|O2|Outcome|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843334|NCT01254045|E1|Reported Event|Intervention: Placebo 48IU|Two participants received placebo 48IU at baseline. Three participants received placebo 48IU at Time 2. Three participants received placebo 48IU at Time 3. This study is a cross-over design.
843335|NCT01253980|B3|Baseline|Total|Total of all reporting groups
843305|NCT01254214|O1|Outcome|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843306|NCT01254214|E2|Reported Event|Support Group|"The Support Group is a group intervention led by a trained facilitator and designed to match the intervention for time, attention and social support~Support group: The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support."
843307|NCT01254214|E1|Reported Event|tMBSR|"telephone-adapted Mindfulness Based Stress Reduction (tMBSR) is an 8-week program of training in mindfulness meditation consisting of two in-person group meetings and 6 conference calls, led by a trained meditation teacher.~tMBSR: MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8."
843308|NCT01254188|B1|Baseline|Nilotinib|Nilotinib 300 mg BID
843309|NCT01254188|P1|Participant Flow|Nilotinib|Nilotinib 300 mg BID
843310|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843311|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843312|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843313|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843314|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843315|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843316|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843317|NCT01254188|O1|Outcome|Nilotinib|Nilotinib 300 mg BID
843318|NCT01254188|E1|Reported Event|Nilotinib|Nilotinib 300 mg BID
843319|NCT01254045|B1|Baseline|All Study Participants|Includes groups randomized to one of six different sequences of three interventions (placebo, oxytocin 24IU, oxytocin 48IU).
843320|NCT01254045|P6|Participant Flow|Placebo 48IU, Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
843321|NCT01254045|P5|Participant Flow|Oxytocin 48IU, Placebo 48IU, Oxytocin 24IU/Placebo 24IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles ; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
843322|NCT01254045|P4|Participant Flow|Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU, Placebo 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
843323|NCT01254045|P3|Participant Flow|Oxytocin 48IU, Oxytocin 24IU/Placebo 24IU, Placebo 48IU|intranasal oxytocin (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
843324|NCT01254045|P2|Participant Flow|Oxytocin 24IU/Placebo 24IU, Placebo 48IU, Oxytocin 48IU|intranasal oxytocin (24 international units; 4IU per puff) and intranasal placebo (24 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal placebo (48 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
843325|NCT01254045|P1|Participant Flow|Placebo 48IU, Oxytocin 24IU/Placebo 24IU, Oxytocin 48IU|intranasal placebo (48 international units; 4IU per puff) once at baseline, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (24 international units; 4IU per puff) and placebo (24 international units; 4IU per puff) once at time 2, 6 puffs (3 puffs per nostril) from each of 2 bottles; intranasal oxytocin (48 international units; 4IU per puff) once at time 3, 6 puffs (3 puffs per nostril) from each of 2 bottles
843326|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
843327|NCT01254045|O2|Outcome|24IU OT|24 international units of intranasal oxytocin and 24 IU of placebo
843328|NCT01254045|O1|Outcome|Placebo|placebo (48 IU)
843329|NCT01254045|O3|Outcome|48IU OT|48 international units of intranasal oxytocin
843330|NCT01254045|O2|Outcome|Oxytocin 24IU/Placebo 24IU|24 international units of intranasal oxytocin and 24 international units of placebo
843331|NCT01254045|O1|Outcome|Placebo|placebo (48IU)
843332|NCT01254045|E3|Reported Event|Intervention: Oxytocin 48IU|Three participants received Oxytocin 48IU at baseline. Two participants received Oxytocin 48IU at Time 2. Three participants received Oxytocin 48IU at Time 3. This study is a cross-over design.
843333|NCT01254045|E2|Reported Event|Intervention: Oxytocin 24IU/Placebo 24IU|Three participants received Oxytocin 24IU/Placebo 24IU at baseline. Three participants received Oxytocin 24IU/Placebo 24IU at Time 2. Two participants received Oxytocin 24IU/Placebo 24IU at Time 3. This study is a cross-over design.
843336|NCT01253980|B2|Baseline|Amoxicillin|Amoxicillin 20-30mg per kg 8 hourly for 5 days
843337|NCT01253980|B1|Baseline|Placebo|Placebo 20-30mg per kg 8 hourly for 5 days
843345|NCT01253902|B3|Baseline|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843346|NCT01253902|B2|Baseline|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
843347|NCT01253902|B1|Baseline|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843348|NCT01253902|P3|Participant Flow|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843349|NCT01253902|P2|Participant Flow|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
843350|NCT01253902|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843351|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843352|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
843353|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843354|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843355|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
843356|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843357|NCT01253902|O3|Outcome|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843358|NCT01253902|O2|Outcome|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
843359|NCT01253902|O1|Outcome|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843360|NCT01253902|E3|Reported Event|Latanoprost Ophthalmic Solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% (Xalatan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843361|NCT01253902|E2|Reported Event|Travoprost Ophthalmic Solution 0.004%|One drop of travoprost ophthalmic solution 0.004% (Travatan Z®) administered to affected eye(s), once daily in the evening for 12 weeks.
843362|NCT01253902|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% (Lumigan®) administered to affected eye(s), once daily in the evening for 12 weeks.
843363|NCT01253824|B3|Baseline|Total|Total of all reporting groups
843364|NCT01253824|B2|Baseline|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
843365|NCT01253824|B1|Baseline|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
843366|NCT01253824|P2|Participant Flow|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
843367|NCT01253824|P1|Participant Flow|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
843368|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
843369|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
843370|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
843371|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
843372|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
843373|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
843374|NCT01253824|O2|Outcome|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
843375|NCT01253824|O1|Outcome|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
843376|NCT01253824|E2|Reported Event|IKH-01|"1mg norethisterone and 0.35mg ethinyl estradiol~IKH-01: IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol"
843377|NCT01253824|E1|Reported Event|NPC-01|"1mg norethisterone and 0.02mg ethinyl estradiol~NPC-01: NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol"
843378|NCT01253811|B1|Baseline|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843414|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843379|NCT01253811|P1|Participant Flow|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843380|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843381|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843382|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843383|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843384|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843385|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843386|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843387|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843388|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843389|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843390|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843522|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843391|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843392|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843393|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843394|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843395|NCT01253811|O1|Outcome|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843396|NCT01253811|E1|Reported Event|rFXIII 35 IU/kg|Subjects received 35 IU/kg recombinant factor XIII (rFXIII) slow intravenous (i.v.) administered every 4 weeks (28 ± 2 days) as preventive treatment of bleeding episodes. Each dose was reconstituted, diluted with saline and injection was given at a rate not exceeding 1-2 mL min-1. This dose was identical to the dose administered in the trial F13CD-3760. The correct dosing was calculated based on subject's body weight. Subjects received rFXIII either at the clinic during the first year or as home treatment after one year, and only if allowed, according to local regulations.
843397|NCT01253577|B1|Baseline|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
843398|NCT01253577|P1|Participant Flow|Sinus Stent|Participants sinuses were randomized to receive drug-coated sinus stent on one side and non-drug coated control stent on the contralateral side in a split-face design.
843399|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
843400|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
843401|NCT01253577|O1|Outcome|All Subjects|
843402|NCT01253577|O2|Outcome|Non-coated Implant Side|Sinus stent without drug coating
843403|NCT01253577|O1|Outcome|Drug-Coated Implant Side|Sinus stent coated with steroid
843404|NCT01253577|E1|Reported Event|All Patients|Patients served as their own controls in the study, with a drug-coated stent placed on one sinus side and a non-drug-coated control placed on contralateral side. Therefore adverse events are listed for the entire 105-patient cohort rather than by treatment group.
843405|NCT01253564|B1|Baseline|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843406|NCT01253564|P1|Participant Flow|Vemurafenib|Participants received vemurafenib tablets, 960 milligrams (mg), twice daily (BID), orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843407|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843408|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843409|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843410|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843411|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843412|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843413|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843415|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843416|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843417|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843418|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843419|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843420|NCT01253564|O1|Outcome|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843421|NCT01253564|E1|Reported Event|Vemurafenib|Participants received vemurafenib tablets, 960 mg, BID, orally continuously until disease progression, unacceptable toxicity, withdrawal of consent, death, other reason deemed by investigator or study termination by the Sponsor.
843422|NCT01253525|B1|Baseline|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843423|NCT01253525|P1|Participant Flow|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843424|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843425|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843426|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843427|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843428|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843429|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843430|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843431|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843432|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843433|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843434|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843435|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843436|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843437|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843438|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843439|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843569|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843440|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843441|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843442|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843443|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843444|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843445|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843446|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843447|NCT01253525|O1|Outcome|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843448|NCT01253525|E1|Reported Event|Ramucirumab + Paclitaxel|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) administered intravenously on Days 1 and 15 of each 28-day cycle.~Paclitaxel: 80 milligrams/square meter (mg/m2) administered intravenously on Days 1, 8, and 15 of each 28-day cycle."
843449|NCT01253447|B1|Baseline|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
843450|NCT01253447|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
843451|NCT01253447|O1|Outcome|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
843452|NCT01253447|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|Akt inhibitor MK2206 200 mg orally once a week for each 28 day treatment cycle
843453|NCT01253408|B4|Baseline|Total|Total of all reporting groups
843454|NCT01253408|B3|Baseline|Placebo|Placebo will be taken orally with water twice per day for two days.
843455|NCT01253408|B2|Baseline|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843456|NCT01253408|B1|Baseline|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843457|NCT01253408|P3|Participant Flow|Placebo|Placebo will be taken orally with water twice per day for two days.
843458|NCT01253408|P2|Participant Flow|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843459|NCT01253408|P1|Participant Flow|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843460|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
843461|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843462|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843463|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
843464|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843465|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843466|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
843467|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843468|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843469|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
843470|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843471|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843472|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
843473|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843474|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843475|NCT01253408|O3|Outcome|Placebo|Placebo will be taken orally with water twice per day for two days.
843476|NCT01253408|O2|Outcome|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843477|NCT01253408|O1|Outcome|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843478|NCT01253408|E3|Reported Event|Placebo|Placebo will be taken orally with water twice per day for two days.
843479|NCT01253408|E2|Reported Event|Dronabinol 5 mg Bid|Dronabinol 5 mg will be taken orally with water twice per day for two days.
843480|NCT01253408|E1|Reported Event|Dronabinol 2.5 mg Bid|Dronabinol 2.5 mg will be taken orally with water twice per day for two days.
843481|NCT01253369|B1|Baseline|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
843570|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843482|NCT01253369|P1|Participant Flow|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
843483|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
843484|NCT01253369|O1|Outcome|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
843485|NCT01253369|E1|Reported Event|Pazopanib|Pazopanib was given at a dose of 800 mg orally once per day for 28 day cycles (+/- 3 days). Patients received treatment as long as they were receiving clinical benefit.
843486|NCT01253343|B3|Baseline|Total|Total of all reporting groups
843487|NCT01253343|B2|Baseline|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score ≤6.5.
843488|NCT01253343|B1|Baseline|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score ≥ 8.
843489|NCT01253343|P2|Participant Flow|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
843490|NCT01253343|P1|Participant Flow|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
843491|NCT01253343|O12|Outcome|High Aggression Group + TestosteroneSample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
843492|NCT01253343|O11|Outcome|High Aggression Group + TestosteroneSample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
843493|NCT01253343|O10|Outcome|High Aggression Group + TestosteroneSample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
843494|NCT01253343|O9|Outcome|High Aggression Group + DHEASample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
843495|NCT01253343|O8|Outcome|High Aggression Group + DHEASample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
843496|NCT01253343|O7|Outcome|High Aggression Group + DHEASample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
843497|NCT01253343|O6|Outcome|Low Aggression Group + TestosteroneSample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
843498|NCT01253343|O5|Outcome|Low Aggression Group + TestosteroneSample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
843499|NCT01253343|O4|Outcome|Low Aggression Group + TestosteroneSample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
843500|NCT01253343|O3|Outcome|Low Aggression Group + DHEA Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
843501|NCT01253343|O2|Outcome|Low Aggression Group + DHEA Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
843502|NCT01253343|O1|Outcome|Low Aggression Group + DHEA Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
843503|NCT01253343|O6|Outcome|High Aggression Group + Cortisol Sample3|High Aggression= BRACHA Score >7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
843504|NCT01253343|O5|Outcome|High Aggression Group + Cortisol Sample2|High Aggression= BRACHA Score >7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
843505|NCT01253343|O4|Outcome|High Aggression Group + Cortisol Sample1|High Aggression= BRACHA Score >7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
843506|NCT01253343|O3|Outcome|Low Aggression Group + Cortisol Sample3|Low Aggression= BRACHA Score <7.5 Saliva Sample 3 was obtained between 3:45pm and 7:45 pm, depending on when the participant last ate food.
843507|NCT01253343|O2|Outcome|Low Aggression Group + Cortisol Sample2|Low Aggression= BRACHA Score <7.5 Saliva Sample 2 was obtained 28-30 minutes after Sample 1
843508|NCT01253343|O1|Outcome|Low Aggression Group + Cortisol Sample1|Low Aggression= BRACHA Score <7.5 Saliva Sample 1 was obtained immediately upon awaking before eating or teeth brushing
843509|NCT01253343|E2|Reported Event|Inpatient Low Aggression|The low- risk group was defined as having a BRACHA score <7.5.
843510|NCT01253343|E1|Reported Event|Inpatient High Aggression|The high- risk group was defined as having a BRACHA score >7.5.
843511|NCT01253304|B5|Baseline|Total|Total of all reporting groups
843512|NCT01253304|B4|Baseline|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843513|NCT01253304|B3|Baseline|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843514|NCT01253304|B2|Baseline|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843515|NCT01253304|B1|Baseline|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843516|NCT01253304|P4|Participant Flow|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843517|NCT01253304|P3|Participant Flow|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843518|NCT01253304|P2|Participant Flow|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection of LY2189265 on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843519|NCT01253304|P1|Participant Flow|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843520|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843521|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843525|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843526|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843527|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843528|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843529|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843530|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843531|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843532|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843533|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843534|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843535|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843536|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843537|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843538|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843539|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843540|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843541|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843542|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843543|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843544|NCT01253304|O4|Outcome|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843545|NCT01253304|O3|Outcome|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843546|NCT01253304|O2|Outcome|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843547|NCT01253304|O1|Outcome|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843548|NCT01253304|E4|Reported Event|Severe Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with severe hepatic impairment (Child-Pugh C)
843549|NCT01253304|E3|Reported Event|Moderate Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with moderate hepatic impairment (Child-Pugh B)
843550|NCT01253304|E2|Reported Event|Mild Hepatic Impairment|LY2189265: A single, SC, 1.5-mg injection on Day 1 in participants with mild hepatic impairment (Child-Pugh A)
843551|NCT01253304|E1|Reported Event|Normal Hepatic Function|LY2189265: A single, subcutaneous (SC), 1.5-milligram (mg) injection on Day 1 in participants with normal hepatic function
843552|NCT01253265|B6|Baseline|Total|Total of all reporting groups
843553|NCT01253265|B5|Baseline|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843554|NCT01253265|B4|Baseline|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843555|NCT01253265|B3|Baseline|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843556|NCT01253265|B2|Baseline|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843557|NCT01253265|B1|Baseline|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843558|NCT01253265|P5|Participant Flow|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843559|NCT01253265|P4|Participant Flow|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843560|NCT01253265|P3|Participant Flow|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843561|NCT01253265|P2|Participant Flow|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843562|NCT01253265|P1|Participant Flow|30 Milligram (mg) LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843563|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843564|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843565|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843566|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843567|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843571|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843572|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843573|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843574|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843575|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843576|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843577|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843578|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843579|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843580|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843581|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843582|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843583|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843584|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843585|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843586|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843587|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843588|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843589|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843590|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843591|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843592|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843593|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843594|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843595|NCT01253265|O5|Outcome|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843596|NCT01253265|O4|Outcome|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843597|NCT01253265|O3|Outcome|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843598|NCT01253265|O2|Outcome|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843599|NCT01253265|O1|Outcome|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843600|NCT01253265|E5|Reported Event|Placebo|Placebo is administered subcutaneously in the same manner as active drug in each dose group
843601|NCT01253265|E4|Reported Event|120 mg LY2439821|240 mg LY2439821 was administered subcutaneously (loading dose) at Week 0, followed by 120 mg LY2439821 administered subcutaneously weekly from Week 1 through Week 10
843602|NCT01253265|E3|Reported Event|180 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843603|NCT01253265|E2|Reported Event|80 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843604|NCT01253265|E1|Reported Event|30 mg LY2439821|Administered subcutaneously at Week 0, 1, 2, 4, 6, 8 and 10
843605|NCT01253187|B1|Baseline|Entire Study Population|Includes all participants treated
843606|NCT01253187|P6|Participant Flow|Treatment Sequence F: Metafolin, EE20/DRSP/L-5-MTHF Ca, YAZ|Metafolin for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; YAZ for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
843607|NCT01253187|P5|Participant Flow|Treatment Sequence E: Metafolin, YAZ, EE20/DRSP/L-5-MTHF Ca|Metafolin for Period 1; YAZ for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
843608|NCT01253187|P4|Participant Flow|Treatment Sequence D: EE20/DRSP/L-5-MTHF Ca, Metafolin, YAZ|EE20/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; YAZ for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP).
843632|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843609|NCT01253187|P3|Participant Flow|Treatment Sequence C: EE20/DRSP/L-5-MTHF Ca, YAZ, Metafolin|EE20/DRSP/L-5-MTHF Ca for Period 1; YAZ for Period 2; Metafolin for Period 3. EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
843610|NCT01253187|P2|Participant Flow|Treatment Sequence B: YAZ, Metafolin, EE20/DRSP/L-5-MTHF Ca|YAZ for Period 1; Metafolin for Period 2; EE20/DRSP/L-5-MTHF Ca for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
843611|NCT01253187|P1|Participant Flow|Treatment Sequence A: YAZ, EE20/DRSP/L-5-MTHF Ca, Metafolin|YAZ for Period 1; EE20/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. YAZ: single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) / EE20/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]) / Metafolin: single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca]).
843612|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843613|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
843614|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843615|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843616|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843617|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843618|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843619|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843620|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843621|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843622|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843623|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843624|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843625|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843626|NCT01253187|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium) [L-5-MTHF Ca]
843627|NCT01253187|O1|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843628|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843629|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843630|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843631|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843633|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843634|NCT01253187|O2|Outcome|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843635|NCT01253187|O1|Outcome|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843636|NCT01253187|E3|Reported Event|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated SHT04532C tablet, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
843637|NCT01253187|E2|Reported Event|EE 0.02mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE20/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532B tablet, containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [MTHF-Ca])
843638|NCT01253187|E1|Reported Event|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|single oral administration of 1 film-coated SHT00186D tablet (YAZ), containing 0.020 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)
843639|NCT01253174|B1|Baseline|Entire Study Population|Includes all participants treated
843640|NCT01253174|P6|Participant Flow|Treatment Sequence F: Metafolin, EE30/DRSP/L-5-MTHF Ca, Yasmin|Metafolin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Yasmin for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
843641|NCT01253174|P5|Participant Flow|Treatment Sequence E: Metafolin, Yasmin, EE30/DRSP/L-5-MTHF Ca|Metafolin for Period 1; Yasmin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
843642|NCT01253174|P4|Participant Flow|Treatment Sequence D: EE30/DRSP/L-5-MTHF Ca, Metafolin, Yasmin|EE30/DRSP/L-5-MTHF Ca for Period 1; Metafolin for Period 2; Yasmin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP).
843643|NCT01253174|P3|Participant Flow|Treatment Sequence C: EE30/DRSP/L-5-MTHF Ca, Yasmin, Metafolin|EE30/DRSP/L-5-MTHF Ca for Period 1; Yasmin for Period 2; Metafolin for Period 3. EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
843644|NCT01253174|P2|Participant Flow|Treatment Sequence B: Yasmin, Metafolin, EE30/DRSP/L-5-MTHF Ca|Yasmin for Period 1; Metafolin for Period 2; EE30/DRSP/L-5-MTHF Ca for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
843645|NCT01253174|P1|Participant Flow|Treatment Sequence A: Yasmin, EE30/DRSP/L-5-MTHF Ca, Metafolin|Yasmin for Period 1; EE30/DRSP/L-5-MTHF Ca for Period 2; Metafolin for Period 3. Yasmin: single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP) / EE30/DRSP/L-5-MTHF Ca: single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]) / Metafolin: single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca]).
843646|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843647|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843648|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843649|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843650|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843651|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843652|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843653|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843654|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843655|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843656|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843657|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843658|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843659|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843660|NCT01253174|O2|Outcome|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843661|NCT01253174|O1|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843662|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843663|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843664|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843665|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843666|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843667|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843668|NCT01253174|O2|Outcome|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843669|NCT01253174|O1|Outcome|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843670|NCT01253174|E3|Reported Event|L-5-MTHF Ca 0.451mg (Metafolin)|single oral administration of 1 coated tablet SHT04532C, containing 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843671|NCT01253174|E2|Reported Event|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 film-coated SHT04532A tablet (with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin (L-5-methyltetrahydrofolate calcium [L-5-MTHF Ca])
843672|NCT01253174|E1|Reported Event|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 film-coated SHT470FA tablet (Yasmin with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
843673|NCT01253148|B1|Baseline|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
843674|NCT01253148|P1|Participant Flow|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
843675|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
843676|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
843780|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
843677|NCT01253148|O1|Outcome|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
843678|NCT01253148|E1|Reported Event|Arterial Injection of 90-Y Microspheres|"Intrahepatic Arterial Injection of 90-Y Glass Microspheres as First-Line Treatment For Cholangiocarcinoma~TheraSphere® Yttrium-90 (Y-90) Microspheres: Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver."
843679|NCT01253135|B1|Baseline|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
843680|NCT01253135|P1|Participant Flow|All Participants|The original protocol (Version 1) called for weekly application of HP802-247 Vehicle alone to the appropriate wound and application of White Petrolatum once weekly to the other wound. After enrollment of the first 15 subjects, scabbing was noted over both wounds, making it impossible to determine the day of wound closure. It was conjectured that the wound environment was becoming too dry. Version 1 of the protocol was stopped and it was amended to Version 2, in which White Petrolatum as applied daily to both wounds. On the days that HP802-247 Vehicle was applied, the White Petrolatum was applied 5 min later to allow the fibrin matrix to mature. 25 subjects were enrolled under Version 2. All 40 subjects enrolled in the study were assessed for safety and the 25 subjects enrolled under Version 2 were assessed for wound closure.
843681|NCT01253135|O2|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
843682|NCT01253135|O1|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
843683|NCT01253135|O2|Outcome|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
843684|NCT01253135|O1|Outcome|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
843685|NCT01253135|E2|Reported Event|Test Article|"802-247 Vehicle (fibrinogen)~Fibrin: Topical application of fibrinogen spray, followed by thrombin spray~HP802-247 Vehicle (260 µL) was applied to the appropriate wound on days 1, 8, and 15. White petrolatum was applied daily. On days 1, 8,and 15 it was applied 5 min after application of HP802-247 Vehicle, to allow the fibrin matrix to mature."
843686|NCT01253135|E1|Reported Event|Control|"White Petrolatum~White Petrolatum: Topical application~White petrolatum was applied daily to the appropriate wound."
843687|NCT01253070|B1|Baseline|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843688|NCT01253070|P1|Participant Flow|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843689|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843690|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843691|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843692|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843781|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
843693|NCT01253070|O2|Outcome|TKD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843694|NCT01253070|O1|Outcome|ITD Mutated Participants|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843695|NCT01253070|E1|Reported Event|Treatment (Daunorubicin, Cytarabine, Sorafenib Tosylate)|"INDUCTION THERAPY: Daunorubicin hydrochloride 60 mg/m^2/day by IV push or short IV on days 1-3, cytarabine 100 mg/m^2/day by continuous IV on days 1-7, and sorafenib tosylate 400 mg orally every 12 hours on days 1-7.~CONSOLIDATION THERAPY - Every 28 days for 2 cycles: Cytarabine 2 g/m^2/day by IV on days 1-5 and sorafenib tosylate 400 mg orally every 12 hours on days 1-28.~MAINTENANCE - Every 28 days for up to 12 cycles: Sorafenib tosylate 400 mg orally every 12 hours on days 1-28."
843696|NCT01253044|B3|Baseline|Total|Total of all reporting groups
843697|NCT01253044|B2|Baseline|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843698|NCT01253044|B1|Baseline|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843699|NCT01253044|P2|Participant Flow|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843700|NCT01253044|P1|Participant Flow|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843701|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843702|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843703|NCT01253044|O2|Outcome|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843704|NCT01253044|O1|Outcome|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843705|NCT01253044|E2|Reported Event|Present Centered Therapy|Present Centered Therapy: Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843706|NCT01253044|E1|Reported Event|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy: Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
843707|NCT01253018|B3|Baseline|Total|Total of all reporting groups
843708|NCT01253018|B2|Baseline|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
843709|NCT01253018|B1|Baseline|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
843710|NCT01253018|P2|Participant Flow|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
843711|NCT01253018|P1|Participant Flow|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using 2 different robots in a sequential 4 week progression in 3 distinct modules: wrist, shoulder-elbow and alternating sessions of wrist and shoulder-elbow robot. Sessions were 3x/week x 60 minutes.
843712|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
843713|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
843714|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
843715|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
843716|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in Robot Therapy combined with transition to task (TTT) practice of functional activities using the hemiparetic arm. Sessions were 3x/week x 60 minutes (45 min robot therapy + 15 min TTT)
843717|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
843838|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
843718|NCT01253018|O2|Outcome|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
843719|NCT01253018|O1|Outcome|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
843720|NCT01253018|E2|Reported Event|Transition to Task Training|12 weeks of robot-assisted upper extremity exercise as described in robot therapy group combined with transition to task (TTT) practice using the hemiparetic arm for functional activities. Session were 3x/week x 60 minutes (45 minutes robot therapy + 15 minutes TTT)
843721|NCT01253018|E1|Reported Event|Robot Therapy|12 weeks of robot-assisted upper extremity exercise using three upper extremity robot modules: wrist, planar, and alternating wrist and planar robot each in a 4 week sequential progression. Sessions 3x/week x 60 minutes
843722|NCT01252966|B3|Baseline|Total|Total of all reporting groups
843723|NCT01252966|B2|Baseline|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843724|NCT01252966|B1|Baseline|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843725|NCT01252966|P2|Participant Flow|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843726|NCT01252966|P1|Participant Flow|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843727|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843728|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843729|NCT01252966|O2|Outcome|Control Training|The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
843730|NCT01252966|O1|Outcome|Cognitive Training|The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
843731|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843732|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843733|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843734|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843735|NCT01252966|O2|Outcome|Control Training|The Control Training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843736|NCT01252966|O1|Outcome|Cognitive Training|The Cognitive Training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function. Participants also receive nicotine patch and smoking cessation counseling.
843737|NCT01252966|E2|Reported Event|Control Training|
843738|NCT01252966|E1|Reported Event|Cognitive Training|
843739|NCT01252940|B3|Baseline|Total|Total of all reporting groups
843740|NCT01252940|B2|Baseline|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843741|NCT01252940|B1|Baseline|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843742|NCT01252940|P2|Participant Flow|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843743|NCT01252940|P1|Participant Flow|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the emtricitabine (FTC)/rilpivirine (RPV)/tenofovir disoproxil fumarate (TDF) single-tablet regimen (STR) at the beginning of the study.
843744|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843745|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
846773|NCT01243242|B2|Baseline|Placebo|Eligible subjects who received 1400 mg of Placebo
843746|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843747|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843748|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843749|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843750|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843751|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843752|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843753|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843754|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843755|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843756|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843757|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843758|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843759|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843760|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843761|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843762|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843763|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843764|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843765|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843766|NCT01252940|O2|Outcome|SBR/Delayed Switch|Participants were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study through Week 24, and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843767|NCT01252940|O1|Outcome|FTC/RPV/TDF|Participants were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843768|NCT01252940|E3|Reported Event|SBR/Delayed Switch (After Week 24)|The adverse events reported in this group are those that occurred after Week 24 in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at Week 24 visit.
843769|NCT01252940|E2|Reported Event|SBR/Delayed Switch (up to Week 24)|The adverse events reported in this group are those that occurred in the first 24 weeks of the study in participants who were randomized to stay on their existing treatment regimen (Stay on Baseline Regimen (SBR)) at the beginning of the study and switch to the FTC/RPV/TDF STR (Delayed Switch) at the Week 24 visit.
843770|NCT01252940|E1|Reported Event|FTC/RPV/TDF|The adverse events reported in this group are those that occurred at any time during the study in participants who were randomized to switch from their existing treatment regimen to the FTC/RPV/TDF STR at the beginning of the study.
843771|NCT01252810|B3|Baseline|Total|Total of all reporting groups
843772|NCT01252810|B2|Baseline|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
843773|NCT01252810|B1|Baseline|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
843774|NCT01252810|P2|Participant Flow|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
843775|NCT01252810|P1|Participant Flow|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
843776|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
843777|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
843778|NCT01252810|O2|Outcome|Iopamidol 370mg I/ml Injection|Iopamidol 370 mg I/mL as a single iv. administration.
843779|NCT01252810|O1|Outcome|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration.
843783|NCT01252810|E1|Reported Event|Ioforminol 320mg I/ml Injection|Ioforminol 320 mg I/mL as a single iv. administration. Up to 7 days post Iopamidol administration.
843784|NCT01252355|B4|Baseline|Total|Total of all reporting groups
843785|NCT01252355|B3|Baseline|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843786|NCT01252355|B2|Baseline|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843787|NCT01252355|B1|Baseline|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843788|NCT01252355|P3|Participant Flow|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843789|NCT01252355|P2|Participant Flow|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843790|NCT01252355|P1|Participant Flow|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843791|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843792|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843793|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843794|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843795|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843796|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843797|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843798|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843799|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843800|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843801|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843802|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843803|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843804|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843805|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843806|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843807|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843808|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843809|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843810|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843811|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843812|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843813|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843814|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843815|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843816|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843817|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843818|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843819|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843820|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843821|NCT01252355|O3|Outcome|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843822|NCT01252355|O2|Outcome|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843823|NCT01252355|O1|Outcome|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843824|NCT01252355|E3|Reported Event|Teriflunomide 14 mg + IFN-beta|Teriflunomide 14 mg once daily concomitantly with IFN-beta.
843825|NCT01252355|E2|Reported Event|Teriflunomide 7 mg + IFN-beta|Teriflunomide 7 mg once daily concomitantly with IFN-beta.
843826|NCT01252355|E1|Reported Event|Placebo + IFN-beta|Placebo (for teriflunomide) once daily concomitantly with IFN-beta.
843827|NCT01252290|B1|Baseline|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843828|NCT01252290|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843829|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843830|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843831|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843832|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843833|NCT01252290|O1|Outcome|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843834|NCT01252290|E1|Reported Event|Lovaza™|Lovaza™: 4 capsules daily for 6 months
843835|NCT01252277|B1|Baseline|Lovaza™|Lovaza™ (two 1 gram capsules twice daily) for six months
843836|NCT01252277|P1|Participant Flow|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
843837|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
843839|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
843840|NCT01252277|O1|Outcome|Lovaza™|Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
843842|NCT01252277|E1|Reported Event|Lovaza™|"Lovaza™ (two 1 gram capsules twice daily) for six months~Lovaza™: 4 capsules daily for 6 months"
843843|NCT01252238|B4|Baseline|Total|Total of all reporting groups
843844|NCT01252238|B3|Baseline|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
843845|NCT01252238|B2|Baseline|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
843846|NCT01252238|B1|Baseline|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
843847|NCT01252238|P3|Participant Flow|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
843848|NCT01252238|P2|Participant Flow|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
843849|NCT01252238|P1|Participant Flow|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
843850|NCT01252238|O3|Outcome|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
843851|NCT01252238|O2|Outcome|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
843852|NCT01252238|O1|Outcome|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
843853|NCT01252238|E3|Reported Event|Valsartan and Aliskiren|"Valsartan 150 mg and Aliskiren (150 mg followed by force titration to 300 mg)~Valsartan and Aliskiren : Subject taking combination of valsartan and aliskiren."
843854|NCT01252238|E2|Reported Event|Placebo Group|"Only taking Amlodipine~Amlodipine : Taking Amlodipine as prescribed by MD for management of high blood pressure."
843855|NCT01252238|E1|Reported Event|Aliskiren|Aliskiren : Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
843856|NCT01252186|B4|Baseline|Total|Total of all reporting groups
843857|NCT01252186|B3|Baseline|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843858|NCT01252186|B2|Baseline|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843859|NCT01252186|B1|Baseline|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843860|NCT01252186|P3|Participant Flow|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843861|NCT01252186|P2|Participant Flow|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843862|NCT01252186|P1|Participant Flow|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843863|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843864|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843865|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843866|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843867|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843868|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843869|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843870|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843871|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843969|NCT01251978|P1|Participant Flow|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
843872|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843873|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843874|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843875|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843876|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843877|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843878|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843879|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843880|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843881|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843882|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843883|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843884|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843885|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843886|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843887|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843888|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843889|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843890|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843891|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843892|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843893|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843894|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843895|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843896|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843897|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843898|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843899|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843900|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843901|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843902|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843903|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843904|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843905|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843906|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843907|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843908|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843909|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843910|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843911|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843912|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843913|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843914|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843915|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843916|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843917|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843918|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843919|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843920|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843921|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843922|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843970|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
843923|NCT01252186|O3|Outcome|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843924|NCT01252186|O2|Outcome|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843925|NCT01252186|O1|Outcome|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843926|NCT01252186|E3|Reported Event|28-day Desogestrel Oral Contraceptive|Participants received 21 days of active combination tablets (containing 150 µg desogestrel (DSG)/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843927|NCT01252186|E2|Reported Event|28-day Levonorgestrel Oral Contraceptive|Participants received 21 days of active combination tablets containing 150 µg LNG/30 µg EE, followed by no treatment for 7 days in each 28-day cycle for a total of six 28-day cycles.
843928|NCT01252186|E1|Reported Event|91-day Levonorgestrel Oral Contraceptive|Participants received 12 weeks (84 consecutive days) of active combination tablets containing 150 µg levonorgestrel (LNG)/30 µg ethinyl estradiol (EE), followed by 7 days of 10 µg EE monotherapy in each 91-day cycle for a total of two 91-day cycles.
843929|NCT01252147|B1|Baseline|All Participants|
843930|NCT01252147|P1|Participant Flow|All Participants|
843931|NCT01252147|O1|Outcome|All Participants|
843932|NCT01252147|O1|Outcome|All Participants|
843933|NCT01252147|E1|Reported Event|All Participants|
843934|NCT01252134|B1|Baseline|Overall|All enrolled participants
843935|NCT01252134|P6|Participant Flow|OTE, Then Synergi, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
843936|NCT01252134|P5|Participant Flow|OTE, Then Biotrue, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
843937|NCT01252134|P4|Participant Flow|Biotrue, Then Synergi, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
843938|NCT01252134|P3|Participant Flow|Biotrue, Then OTE, Then Synergi|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
843939|NCT01252134|P2|Participant Flow|Synergi, Then OTE, Then Biotrue|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
843940|NCT01252134|P1|Participant Flow|Synergi, Then Biotrue, Then OTE|Three lens care systems randomly assigned. Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours, with a minimum two-day washout between each wear period.
843941|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843942|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843943|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843944|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843945|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843946|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843947|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843948|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843949|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843950|NCT01252134|O3|Outcome|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843951|NCT01252134|O2|Outcome|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843952|NCT01252134|O1|Outcome|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843953|NCT01252134|E3|Reported Event|OTE Elements|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843954|NCT01252134|E2|Reported Event|Bio-True|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843955|NCT01252134|E1|Reported Event|Synergi|Contact lenses were pre-soaked overnight prior to insertion, then worn for 8 hours.
843956|NCT01252095|B3|Baseline|Total|Total of all reporting groups
843957|NCT01252095|B2|Baseline|50 mg Dose|50 mg PG545/week
843958|NCT01252095|B1|Baseline|25 mg Dose|25 mg PG545/week
843959|NCT01252095|P2|Participant Flow|50 mg Dose|50 mg PG545/week
843960|NCT01252095|P1|Participant Flow|25 mg Dose|25 mg PG545/week
843961|NCT01252095|O2|Outcome|50 mg Dose|50 mg PG545/week
843962|NCT01252095|O1|Outcome|25 mg Dose|25 mg PG545/week
843963|NCT01252095|E2|Reported Event|50 mg Dose|50 mg PG545/week
843964|NCT01252095|E1|Reported Event|25 mg Dose|25 mg PG545/week
843965|NCT01251978|B3|Baseline|Total|Total of all reporting groups
843966|NCT01251978|B2|Baseline|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
843967|NCT01251978|B1|Baseline|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
843968|NCT01251978|P2|Participant Flow|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
846774|NCT01243242|B1|Baseline|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
843971|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
843972|NCT01251978|O2|Outcome|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
843973|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
843974|NCT01251978|O1|Outcome|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
843975|NCT01251978|E2|Reported Event|Standard Dose Ranibizumab|"patients will receive 0.5 mg of Ranibizumab every two weeks per 3 months.~0.5 mg Ranibizumab: 6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months."
843976|NCT01251978|E1|Reported Event|High Dose Ranibizumab|"patients will receive 3 injections of Ranibizumab (2 mg) a month apart.~Ranibizumab 2 mg: intravitreal injections of ranibizumab once a month, times 3."
843977|NCT01251952|B1|Baseline|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
843978|NCT01251952|P1|Participant Flow|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
843979|NCT01251952|O1|Outcome|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
843980|NCT01251952|E1|Reported Event|Denileukin Diftitox (Ontak)|"Denileukin Diftitox (Ontak) administered Post Autologous Transplantation.~Denileukin Diftitox (Ontak) : After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
843981|NCT01251770|B3|Baseline|Total|Total of all reporting groups
843982|NCT01251770|B2|Baseline|ClNa 0.45%|maintenance solution with ClNa 0.45%
843983|NCT01251770|B1|Baseline|ClNa 0.3%|maintenance solution with ClNa 0.3%
843984|NCT01251770|P2|Participant Flow|ClNa 0.45%|maintenance solution with ClNa 0.45%
843985|NCT01251770|P1|Participant Flow|ClNa 0.3%|maintenance solution with ClNa 0.3%
843986|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
843987|NCT01251770|O1|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
843988|NCT01251770|O2|Outcome|ClNa 0.45%|maintenance solution with ClNa 0.45%
843989|NCT01251770|O1|Outcome|ClNa 0.3%|maintenance solution with ClNa 0.3%
843990|NCT01251770|E2|Reported Event|ClNa 0.45%|maintenance solution with ClNa 0.45%
843991|NCT01251770|E1|Reported Event|ClNa 0.3%|maintenance solution with ClNa 0.3%
843992|NCT01251757|B4|Baseline|Total|Total of all reporting groups
843993|NCT01251757|B3|Baseline|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
843994|NCT01251757|B2|Baseline|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
843995|NCT01251757|B1|Baseline|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
843996|NCT01251757|P3|Participant Flow|Enhanced IVR (IVR+)|"Participants in the IVR+ arm received all components of the IVR intervention and in addition were mailed educational materials bimonthly during the intervention. In addition, both IVR+ participants and their primary care providers received mailed notifications when they did not fill their medications in response to the automated calls.~The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as FAQs about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers."
844039|NCT01251653|P6|Participant Flow|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844265|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
843997|NCT01251757|P2|Participant Flow|Interactive Voice Recognition (IVR)|"In addition to their usual care, participants in the Interactive Voice Recognition (IVR) arm received automated phone calls, triggered by dispensing events in the electronic medical record (EMR), to educate patients about their medications and assist them in refilling their prescriptions.~The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the EMR. Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
843998|NCT01251757|P1|Participant Flow|Usual Care (UC)|Participants in this arm had full access to all care they were normally entitled to as part of usual care
843999|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
844000|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
844001|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
844002|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
844003|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
844004|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
844005|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
844006|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
844007|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
844008|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
844009|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm .
844010|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
844011|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
844012|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
844013|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
844014|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
844015|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
844016|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
844017|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|ACEI/ARB users in IVR+ arm
844018|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|ACEI/ARB users in IVR arm
844019|NCT01251757|O1|Outcome|Usual Care (UC)|ACEI/ARB users in UC arm
844020|NCT01251757|O3|Outcome|Enhanced IVR (IVR+)|statin users in IVR+ arm
844021|NCT01251757|O2|Outcome|Interactive Voice Recognition (IVR)|statin users in IVR arm
844022|NCT01251757|O1|Outcome|Usual Care (UC)|statin users in UC arm
844023|NCT01251757|E3|Reported Event|Enhanced IVR (IVR+)|usual care plus automated phone calls plus educational mailings and mail follow-up for persistent nonadherence
844024|NCT01251757|E2|Reported Event|Interactive Voice Recognition (IVR)|usual care plus automated phone calls
844025|NCT01251757|E1|Reported Event|Usual Care (UC)|usual medical care
844026|NCT01251653|B10|Baseline|Total|Total of all reporting groups
844027|NCT01251653|B9|Baseline|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844028|NCT01251653|B8|Baseline|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844029|NCT01251653|B7|Baseline|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844030|NCT01251653|B6|Baseline|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844031|NCT01251653|B5|Baseline|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844032|NCT01251653|B4|Baseline|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844033|NCT01251653|B3|Baseline|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844034|NCT01251653|B2|Baseline|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844035|NCT01251653|B1|Baseline|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844036|NCT01251653|P9|Participant Flow|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844037|NCT01251653|P8|Participant Flow|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844038|NCT01251653|P7|Participant Flow|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844253|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844254|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844040|NCT01251653|P5|Participant Flow|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844041|NCT01251653|P4|Participant Flow|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844042|NCT01251653|P3|Participant Flow|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844043|NCT01251653|P2|Participant Flow|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844044|NCT01251653|P1|Participant Flow|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844045|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844046|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844047|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844048|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844049|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844050|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844051|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844052|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844053|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844054|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844055|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844056|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844057|NCT01251653|O4|Outcome|Docetaxel 75mg Without Afatinib|Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844058|NCT01251653|O3|Outcome|Docetaxel 75mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844059|NCT01251653|O2|Outcome|Docetaxel 60mg Without Afatinib|Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844060|NCT01251653|O1|Outcome|Docetaxel 60mg With Afatinib 30mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844061|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844062|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844063|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844064|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844065|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844066|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844067|NCT01251653|O2|Outcome|Gemcitabine 1000mg Without Afatinib|Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844068|NCT01251653|O1|Outcome|Gemcitabine 1000mg With Afatinib 40 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844069|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
844070|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844071|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
844072|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844073|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
844074|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844075|NCT01251653|O6|Outcome|Afatinib 30mg Without Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
844076|NCT01251653|O5|Outcome|Afatinib 30mg With Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844077|NCT01251653|O4|Outcome|Afatinib 30mg Without Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in 3- week treatment course.
844078|NCT01251653|O3|Outcome|Afatinib 30mg With Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844079|NCT01251653|O2|Outcome|Afatinib 40mg Without Gemcitabine|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in 3- week treatment course.
844080|NCT01251653|O1|Outcome|Afatinib 40mg With Gemcitabine 1000 mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844081|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844082|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844083|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844084|NCT01251653|O3|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844085|NCT01251653|O2|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844086|NCT01251653|O1|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844087|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844088|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844089|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844090|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844091|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844092|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844093|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844094|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844095|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844096|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844097|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844098|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844099|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844255|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844100|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844101|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844102|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844103|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844104|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844105|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844106|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844107|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844108|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844109|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844110|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844111|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844112|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844113|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844114|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844115|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844116|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844117|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844118|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844119|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844120|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844121|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844122|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844123|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844124|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844125|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844126|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844127|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844128|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844129|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844130|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844131|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844132|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844133|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844134|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844135|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844136|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844137|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844138|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844139|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844140|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844141|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844142|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844143|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844144|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844145|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844146|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844147|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844148|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844149|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844150|NCT01251653|O9|Outcome|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844151|NCT01251653|O8|Outcome|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844152|NCT01251653|O7|Outcome|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844153|NCT01251653|O6|Outcome|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course
844154|NCT01251653|O5|Outcome|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844155|NCT01251653|O4|Outcome|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844156|NCT01251653|O3|Outcome|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844157|NCT01251653|O2|Outcome|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844158|NCT01251653|O1|Outcome|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844159|NCT01251653|E9|Reported Event|Afatinib 50mg and Docetaxel 75mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844160|NCT01251653|E8|Reported Event|Afatinib 40mg and Docetaxel 75mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844161|NCT01251653|E7|Reported Event|Afatinib 30mg and Docetaxel 75mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 75 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844162|NCT01251653|E6|Reported Event|Afatinib 30mg and Docetaxel 60mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Docetaxel 60 mg/m2 administered as intravenous infusion on Day 1 of each 3- week treatment course.
844163|NCT01251653|E5|Reported Event|Afatinib 50mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844164|NCT01251653|E4|Reported Event|Afatinib 40mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844165|NCT01251653|E3|Reported Event|Afatinib 40mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844166|NCT01251653|E2|Reported Event|Afatinib 30mg and Gemcitabine 1250mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1250 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844167|NCT01251653|E1|Reported Event|Afatinib 30mg and Gemcitabine 1000mg|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Gemcitabine 1000 mg/m2 administered as intravenous infusion on Days 1 and 8 of each 3- week treatment course.
844168|NCT01251614|B4|Baseline|Total|Total of all reporting groups
844169|NCT01251614|B3|Baseline|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844170|NCT01251614|B2|Baseline|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844171|NCT01251614|B1|Baseline|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844237|NCT01251614|E8|Reported Event|Period C: Adalimumab 0.8 mg/kg|Participants initially randomized to either methotrexate or adalimumab 0.8 mg/kg with loss of disease control in Period B received adalimumab 0.8 mg/kg eow for up to 16 weeks in Period C.
844256|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844257|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844172|NCT01251614|P3|Participant Flow|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844173|NCT01251614|P2|Participant Flow|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844174|NCT01251614|P1|Participant Flow|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844175|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844176|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844177|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844178|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844238|NCT01251614|E7|Reported Event|Period C: Adalimumab 0.4 mg/kg|Participants initially randomized to adalimumab 0.4 mg/kg with loss of disease control in Period B received adalimumab 0.4 mg/kg eow for up to 16 weeks in Period C.
844239|NCT01251614|E6|Reported Event|Period B: ADA 0.8 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.8 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
844258|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844179|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844180|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844181|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844182|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844183|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844184|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844185|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844186|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844187|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844240|NCT01251614|E5|Reported Event|Period B: ADA 0.4 mg/kg/No Treatment|Participants initially randomized to adalimumab (ADA) 0.4 mg/kg who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
844241|NCT01251614|E4|Reported Event|Period B: MTX/No Treatment|Participants initially randomized to methotrexate who responded in Period A were withdrawn from active therapy in Period B for up to 36 weeks.
844259|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844188|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844189|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844190|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844191|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844192|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844193|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844194|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844242|NCT01251614|E3|Reported Event|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844260|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844261|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844195|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844196|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844197|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844198|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844199|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844200|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844201|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844243|NCT01251614|E2|Reported Event|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844262|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844263|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844202|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844203|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844204|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844205|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844206|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844207|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844208|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844244|NCT01251614|E1|Reported Event|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844245|NCT01251588|B3|Baseline|Total|Total of all reporting groups
844246|NCT01251588|B2|Baseline|Microfracture|Microfracture: Arthroscopic Microfracture
844209|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844210|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844211|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844212|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844213|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844214|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844215|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets. Participants who were non-responders in Period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.4 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.4 mg/kg eow.
844247|NCT01251588|B1|Baseline|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844248|NCT01251588|P2|Participant Flow|Microfracture|Microfracture: Arthroscopic Microfracture
844249|NCT01251588|P1|Participant Flow|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844250|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844251|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844216|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1. Participants who were non-responders in period A entered Period D directly and received open-label adalimumab at 0.8 mg/kg eow for up to 52 weeks. Participants who responded in Period A entered the Treatment Withdrawal Phase (Period B) for up to 36 weeks. Participants who experienced a loss of disease control in Period B entered the Re-treatment Phase (Period C) and received blinded adalimumab 0.8 mg/kg eow for 16 weeks. Participants who completed Period B with no loss of disease control entered Period D and were observed off study medication for up to 52 weeks. Participants who completed Period C entered Period D for an additional 52 weeks of treatment with blinded adalimumab 0.8 mg/kg eow.
844217|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844218|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844219|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844220|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844221|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844222|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844223|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844224|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844225|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844226|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844227|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844228|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844229|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844230|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844231|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844232|NCT01251614|O3|Outcome|Adalimumab 0.8 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.8 mg/kg (up to a maximum of 40 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844233|NCT01251614|O2|Outcome|Adalimumab 0.4 mg/kg|In Period A participants received a single subcutaneous loading dose of adalimumab 0.4 mg/kg (up to a maximum of 20 mg) at Week 0 followed by every other week dosing beginning at Week 1. To maintain the blind, participants also received weekly dosing of methotrexate placebo tablets.
844234|NCT01251614|O1|Outcome|Methotrexate|Participants received 0.1 mg/kg methotrexate at Baseline (Week 0), and up to 0.4 mg/kg weekly (maximum dose of 25 mg/week) in Period A. Participants also received adalimumab placebo as a single subcutaneous loading dose at Week 0, followed by every other week (eow) dosing from Week 1.
844235|NCT01251614|E10|Reported Event|Period D: Adalimumab 0.8 mg/kg|Participants received adalimumab 0.8 mg/kg eow for up to 52 weeks in Period D.
844236|NCT01251614|E9|Reported Event|Period D: Adalimumab 0.4 mg/kg|Participants received adalimumab 0.4 mg/kg eow for up to 52 weeks in Period D.
844252|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844266|NCT01251588|O2|Outcome|Microfracture|"Microfracture treatment received in previous MACI00206 study~Microfracture: Arthroscopic Microfracture treatment received in the previous MACI00206 study"
844267|NCT01251588|O1|Outcome|MACI|"autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study~autologous cultured chondrocytes on porcine collagen membrane: Implantation received in the previous MACI00206 study"
844268|NCT01251588|O2|Outcome|Microfracture|"Microfracture treatment received in previous MACI00206 study~Microfracture: Arthroscopic Microfracture treatment received in the previous MACI00206 study"
844269|NCT01251588|O1|Outcome|MACI|"autologous cultured chondrocytes on porcine collagen membrane implant received in previous MACI00206 study~autologous cultured chondrocytes on porcine collagen membrane: Implantation received in the previous MACI00206 study"
844270|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844271|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844272|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844273|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844274|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844275|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844276|NCT01251588|O2|Outcome|Microfracture|Microfracture: Arthroscopic Microfracture
844277|NCT01251588|O1|Outcome|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844278|NCT01251588|E2|Reported Event|Microfracture|Microfracture: Arthroscopic Microfracture
844279|NCT01251588|E1|Reported Event|MACI|autologous cultured chondrocytes on porcine collagen membrane: Implantation
844280|NCT01251380|B1|Baseline|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844281|NCT01251380|P1|Participant Flow|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844282|NCT01251380|O3|Outcome|Dysport Treatment Cycle 3|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844283|NCT01251380|O2|Outcome|Dysport Treatment Cycle 2|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844284|NCT01251380|O1|Outcome|Dysport Treatment Cycle 1|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844285|NCT01251380|O3|Outcome|Dysport Treatment Cycle 3|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844286|NCT01251380|O2|Outcome|Dysport Treatment Cycle 2|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844287|NCT01251380|O1|Outcome|Dysport Treatment Cycle 1|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844288|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844289|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844290|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844291|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844292|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844293|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844294|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844295|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5U/kg to 20U/kg for one leg and 10U/kg to 30U/kg for both legs
844296|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844297|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844298|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844299|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844300|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844301|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs
844631|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844302|NCT01251380|O1|Outcome|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
844303|NCT01251380|E1|Reported Event|Total Dysport|Dysport was injected into the affected GSC with / without Hamstring injections at doses ranging between 5 U/kg to 20 U/kg for one leg and 10 U/kg to 30 U/kg for both legs.
844304|NCT01251354|B1|Baseline|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844305|NCT01251354|P1|Participant Flow|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844306|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844307|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844308|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844309|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844310|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844311|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844312|NCT01251354|O1|Outcome|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844313|NCT01251354|E1|Reported Event|BN83495|BN83495: 1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
844314|NCT01251315|B7|Baseline|Total|Total of all reporting groups
844315|NCT01251315|B6|Baseline|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
844316|NCT01251315|B5|Baseline|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group ( 1200mg oral X1)
844317|NCT01251315|B4|Baseline|Placebo-B|High dose oral X1
844318|NCT01251315|B3|Baseline|Proimmune 200-A|Proimmune 200 low dose group (3000mg oral X 1)
844319|NCT01251315|B2|Baseline|N Acetyl Cysteine-A|N Acetyl cysteine low dose group (600mg oral X1)
844320|NCT01251315|B1|Baseline|Placebo-A|low dose oral x1
844321|NCT01251315|P6|Participant Flow|Proimmune 200 (High Dose, 6000 mg Oral as a Single Dose)|Proimmune 200 (high dose, 6000 mg oral as a single dose)
844322|NCT01251315|P5|Participant Flow|N Acetyl Cysteine (High Dose, 1200 mg Oral as a Single Dose)|N Acetyl cysteine (high dose 1200 mg oral as a single dose)
844323|NCT01251315|P4|Participant Flow|Placebo High Dose Group, Given Oral as a Single Dose|Placebo high dose group, given oral as a single dose
844324|NCT01251315|P3|Participant Flow|Proimmune 200 (Low Dose, 3000 mg Oral as a Single Dose)|Proimmune 200 (low dose, 3000 mg oral as a single dose)
844325|NCT01251315|P2|Participant Flow|N Acetyl Cysteine (Low Dose, 600mg Oral as a Single Dose)|N Acetyl cysteine (low dose, 600mg oral as a single dose)
844326|NCT01251315|P1|Participant Flow|Placebo Low Dose Group, Given Oral as a Single Dose|Placebo low dose group, given oral as a single dose
844327|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group
844328|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
844329|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
844330|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group
844331|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
844332|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
844333|NCT01251315|O6|Outcome|Proimmune 200-B|Proimmune 200 High dose group (6000mg oral x1)
844334|NCT01251315|O5|Outcome|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group (1200 mg oral x1)
844335|NCT01251315|O4|Outcome|Placebo-B|Placebo High dose group
844336|NCT01251315|O3|Outcome|Proimmune 200-A|Proimmune 200 low dose group ( 3000mg oral x1)
844337|NCT01251315|O2|Outcome|N Acetyl Cysteine-A|N Acetyl cysteine low dose group ( 600mg oral x1)
844338|NCT01251315|O1|Outcome|Placebo-A|Placebo low dose group
844339|NCT01251315|E6|Reported Event|Proimmune 200-B|Proimmune 200 High dose group
844340|NCT01251315|E5|Reported Event|N Acetyl Cysteine-B|N Acetyl Cysteine High dose group
844341|NCT01251315|E4|Reported Event|Placebo-B|High dose group
844342|NCT01251315|E3|Reported Event|Proimmune 200-A|Proimmune 200 low dose group
844343|NCT01251315|E2|Reported Event|N Acetyl Cysteine-A|N Acetyl cysteine low dose group
844344|NCT01251315|E1|Reported Event|Placebo-A|low dose group
844345|NCT01251146|B3|Baseline|Total|Total of all reporting groups
844346|NCT01251146|B2|Baseline|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844347|NCT01251146|B1|Baseline|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844506|NCT01250769|P3|Participant Flow|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844666|NCT01250509|O2|Outcome|Waitlist|
844348|NCT01251146|P2|Participant Flow|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844349|NCT01251146|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844350|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844351|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844352|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844353|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844354|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844355|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844384|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844385|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844507|NCT01250769|P2|Participant Flow|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844508|NCT01250769|P1|Participant Flow|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844356|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844357|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844358|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844359|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844360|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844361|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844362|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844363|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844386|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844387|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844388|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844364|NCT01251146|O2|Outcome|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844365|NCT01251146|O1|Outcome|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844366|NCT01251146|E2|Reported Event|Atenolol|Atenolol was administered at a dose of 50 mg once daily for 2 weeks. If the heart rate was less than or equal to 65 bpm at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 75 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate still greater than 65 bpm at Week 4, then the dose was further increased to 100 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose administered for another 2 weeks. If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844367|NCT01251146|E1|Reported Event|Bisoprolol|Bisoprolol was administered at a dose of 5 milligram (mg) once daily for 2 weeks. If the heart rate was less than or equal to 65 beats per minute (bpm) at Week 2, then the initial dose was administered for another 2 weeks (up to Week 4). If the heart rate was greater than 65 bpm at Week 2, then the dose was further increased to 7.5 mg once daily for 2 weeks (up to Week 4). If the heart rate was less than or equal to 65 bpm at Week 4, the increased dose was administered for another 2 weeks (up to Week 6). If the heart rate was still greater than 65 bpm at Week 4, then the dose was further increased to 10 mg once daily for 2 weeks (up to Week 6). If the heart rate was less than or equal to 65 bpm at Week 6, the increased dose was administered for another 2 weeks (up to Week 8). If the heart rate was still greater than 65 bpm, then the treatment was ceased.
844368|NCT01251120|B3|Baseline|Total|Total of all reporting groups
844369|NCT01251120|B2|Baseline|Placebo|Participants received Non-biologic DMARDs (including methotrexate) according to current best practice
844370|NCT01251120|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)
844371|NCT01251120|P2|Participant Flow|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844372|NCT01251120|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously every 4 weeks along with background disease-modifying antirheumatic drugs (DMARDs) including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844373|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844374|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844375|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844376|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844377|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844378|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844379|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844380|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844381|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844382|NCT01251120|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844383|NCT01251120|O2|Outcome|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844474|NCT01250925|E2|Reported Event|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844389|NCT01251120|E2|Reported Event|Non-biologic DMARDs|Participants received non-biologic DMARDs (including methotrexate) according to current best practice. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844390|NCT01251120|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenously every 4 weeks along with background DMARDs including methotrexate. All participants who received methotrexate also received at least 5 mg oral folic acid weekly.
844391|NCT01251042|B3|Baseline|Total|Total of all reporting groups
844392|NCT01251042|B2|Baseline|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844393|NCT01251042|B1|Baseline|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844394|NCT01251042|P2|Participant Flow|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844395|NCT01251042|P1|Participant Flow|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844396|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844397|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844398|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844399|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844400|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844401|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844402|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844403|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844404|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844405|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844406|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844407|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844408|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844409|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844410|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844411|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844412|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844413|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844414|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844415|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844416|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844417|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844418|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844419|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844420|NCT01251042|O2|Outcome|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844421|NCT01251042|O1|Outcome|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844422|NCT01251042|E2|Reported Event|Sangvia and no Retransfusion|Blood collected with Sangvia but discarded, i.e. not retransfused.
844423|NCT01251042|E1|Reported Event|Sangvia and Retransfusion|Blood collected and retransfused with Sangvia.
844424|NCT01250990|B3|Baseline|Total|Total of all reporting groups
844425|NCT01250990|B2|Baseline|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
844426|NCT01250990|B1|Baseline|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
844427|NCT01250990|P2|Participant Flow|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
844428|NCT01250990|P1|Participant Flow|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
844429|NCT01250990|O2|Outcome|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
844430|NCT01250990|O1|Outcome|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
844431|NCT01250990|E2|Reported Event|Placebo|"Placebo tablet with 50 mg niacin for the first 4 weeks to maintain blinding of the study team and subjects, changed to pure placebo after that.~Placebo: Placebo"
844475|NCT01250925|E1|Reported Event|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844432|NCT01250990|E1|Reported Event|Niacin|"Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.~Niacin: Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated."
844433|NCT01250925|B4|Baseline|Total|Total of all reporting groups
844434|NCT01250925|B3|Baseline|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844435|NCT01250925|B2|Baseline|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844436|NCT01250925|B1|Baseline|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844437|NCT01250925|P3|Participant Flow|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844438|NCT01250925|P2|Participant Flow|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844439|NCT01250925|P1|Participant Flow|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844440|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844441|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844442|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844443|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844444|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844445|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844446|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844447|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844448|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844449|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844450|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844451|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844452|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844453|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844454|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844455|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844456|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844457|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844458|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844459|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844460|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844461|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844462|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844463|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844464|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844465|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844466|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844467|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844468|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844469|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844470|NCT01250925|O3|Outcome|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844471|NCT01250925|O2|Outcome|Clear Care®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844472|NCT01250925|O1|Outcome|OPTI-FREE® RepleniSH®|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844473|NCT01250925|E3|Reported Event|ReNu MultiPlus® MultiPurpose Solution|33 participants will be assigned to use this lens care regimen during the six-week assessment period
844476|NCT01250899|B3|Baseline|Total|Total of all reporting groups
844667|NCT01250509|O1|Outcome|CALMM|
844477|NCT01250899|B2|Baseline|Vitamin D Insufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks.
844478|NCT01250899|B1|Baseline|Vitamin D Sufficient|HIV-infected men and women on stable ART with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
844479|NCT01250899|P2|Participant Flow|Vitamin D Insufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D <30ng/mL received open-label, oral vitamin D3 50,000 IU twice weekly for 5 weeks, then 2000 IU daily to complete 12 weeks. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
844480|NCT01250899|P1|Participant Flow|Vitamin D Sufficient|HIV-infected men and women on stable ART underwent routine serum 25(OH)D screening. Persons with HIV-1 RNA <200 copies/mL and reported taking daily vitamin D <400 IU were eligible to participate. Subjects with 25(OH)D ≥30ng/mL had a baseline visit only, and did not receive vitamin D supplementation.
844481|NCT01250899|O1|Outcome|Vitamin D Insufficient|Baseline 25(OH)D <30 ng/mL received 12 weeks of oral vitamin D supplementation. Serum 25(OH)D levels were measured at baseline, 12 weeks and 24 weeks.
844482|NCT01250899|E1|Reported Event|Vitamin D Insufficient|25(OH)D <30 mg/mL at study entry (i.e. group of patients receiving vitamin D supplementation).
844483|NCT01250834|B1|Baseline|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
844484|NCT01250834|P1|Participant Flow|LY2189265 + Atorvastatin|"Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.~Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3."
844485|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
844486|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
844487|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
844488|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
844489|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
844490|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
844491|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
844492|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
844493|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
844494|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
844495|NCT01250834|O2|Outcome|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3.
844496|NCT01250834|O1|Outcome|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
844497|NCT01250834|E3|Reported Event|1.5 mg LY2189265 + 40 mg Atorvastatin|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was after the atorvastatin dose on Day 3 in Period 2.
844498|NCT01250834|E2|Reported Event|1.5 mg LY2189265|Period 2: Participants received a single 1.5-mg subcutaneous dose of LY2189265 on Day 1, followed by a single 40-mg oral dose of atorvastatin on Day 3. The time period for this arm was from Day 1 to predose of atorvastatin on Day 3.
844499|NCT01250834|E1|Reported Event|40 mg Atorvastatin Alone|Period 1: Participants received a single 40-milligram (mg) oral dose of atorvastatin on Day 1, followed by a 7- to 10-day washout period between Day 1 of Period 1 and Day 1 of Period 2.
844500|NCT01250769|B5|Baseline|Total|Total of all reporting groups
844501|NCT01250769|B4|Baseline|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844502|NCT01250769|B3|Baseline|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844503|NCT01250769|B2|Baseline|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844504|NCT01250769|B1|Baseline|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844505|NCT01250769|P4|Participant Flow|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844630|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844509|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844510|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844511|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844512|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844513|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844514|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844515|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844516|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844517|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844518|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844519|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844520|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844521|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844522|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844523|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844524|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844525|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844526|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844527|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844528|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844529|NCT01250769|O4|Outcome|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844530|NCT01250769|O3|Outcome|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844531|NCT01250769|O2|Outcome|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844532|NCT01250769|O1|Outcome|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844533|NCT01250769|E4|Reported Event|Manual Toothbrush + Interproximal Cleaning 2|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used twice a day.
844534|NCT01250769|E3|Reported Event|Manual Toothbrush + Interproximal Cleaning 1|Manual Toothbrush used twice a day for 2 minutes plus Interproximal Cleaning Device used once a day.
844535|NCT01250769|E2|Reported Event|Manual Toothbrush 2|Manual Toothbrush used for 2 minutes twice a day.
844536|NCT01250769|E1|Reported Event|Manual Toothbrush 1|Manual Toothbrush used for 1 minute twice a day.
844537|NCT01250756|B3|Baseline|Total|Total of all reporting groups
844538|NCT01250756|B2|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844539|NCT01250756|B1|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844540|NCT01250756|P2|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844541|NCT01250756|P1|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844542|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844620|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844621|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844543|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844544|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844545|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844546|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844547|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844548|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844549|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844550|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844551|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844552|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844553|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844554|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844555|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844622|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844623|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844556|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844557|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844558|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844559|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844560|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844561|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844562|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844563|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844564|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844565|NCT01250756|O1|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844566|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844567|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844568|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844624|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844625|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844626|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844569|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844570|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844571|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844572|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844573|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844574|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844575|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844576|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844577|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844578|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844579|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844580|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844581|NCT01250756|O2|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
844627|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844628|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844629|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844582|NCT01250756|O1|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 7vPnC dose.
844583|NCT01250756|E7|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
844584|NCT01250756|E6|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
844585|NCT01250756|E5|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
844586|NCT01250756|E4|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
844587|NCT01250756|E3|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
844588|NCT01250756|E2|Reported Event|DTaP (Catch-up 7vPnC)- Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
844589|NCT01250756|E1|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
844590|NCT01250730|B4|Baseline|Total|Total of all reporting groups
844591|NCT01250730|B3|Baseline|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844592|NCT01250730|B2|Baseline|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844593|NCT01250730|B1|Baseline|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844594|NCT01250730|P3|Participant Flow|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844595|NCT01250730|P2|Participant Flow|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844596|NCT01250730|P1|Participant Flow|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844597|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844598|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844599|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844600|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844601|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844602|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844603|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844604|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844605|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844606|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844607|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844608|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844609|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844610|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844611|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844612|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844613|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844614|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844615|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844616|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844617|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844618|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844619|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
846775|NCT01243242|P2|Participant Flow|Placebo|Eligible subjects who received 1400 mg of Placebo
844632|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844633|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844634|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844635|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844636|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844637|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844638|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844639|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844640|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844641|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844642|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844643|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844644|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844645|NCT01250730|O3|Outcome|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844646|NCT01250730|O2|Outcome|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844647|NCT01250730|O1|Outcome|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844648|NCT01250730|E3|Reported Event|Crizotinib 400 mg|A 400 mg single dose of crizotinib administered as four 100 mg IRTs.
844649|NCT01250730|E2|Reported Event|Crizotinib 250 mg|A 250 mg single dose of crizotinib administered as one 50 mg IRT and two 100 mg IRTs
844650|NCT01250730|E1|Reported Event|Crizotinib 150 mg|A 150 mg single dose of crizotinib administered as one 50 mg Immediate Release Tablet (IRT) and one 100 mg IRT
844651|NCT01250717|B1|Baseline|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
844652|NCT01250717|P1|Participant Flow|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
844653|NCT01250717|O1|Outcome|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
844654|NCT01250717|E1|Reported Event|Docetaxel Followed by Radical Prostatectomy|"This is a single arm study and there were no arms other than the one arm. All participants were treated according to the regimen below.~Docetaxel Followed by Radical Prostatectomy~Radical Prostatectomy : after the chemo and hormonal therapy all patients have a radical prostatectomy~Zoladex : Given subcutaneously for 4 doses every three months~Casodex : Taken orally once a day for 6 months~Estramustine : Taken orally three times a day for 5 days for the first part of every three week cycle~Docetaxel : Given by an IV infusion over 1 hour on day 2 of a three-week cycle~Dexamethasone : Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel"
844655|NCT01250509|B3|Baseline|Total|Total of all reporting groups
844656|NCT01250509|B2|Baseline|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
844657|NCT01250509|B1|Baseline|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
844658|NCT01250509|P2|Participant Flow|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
844659|NCT01250509|P1|Participant Flow|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
844660|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
844661|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
844662|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
844663|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
844664|NCT01250509|O2|Outcome|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
844665|NCT01250509|O1|Outcome|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
844668|NCT01250509|E2|Reported Event|Waitlist Control|Participants were waitlisted for the intervention during the experimental phase.
844669|NCT01250509|E1|Reported Event|CALMM|Participants receiving CALMM intervention, i.e. program that combines stress reduction with mindful eating practices.
844670|NCT01250418|B3|Baseline|Total|Total of all reporting groups
844671|NCT01250418|B2|Baseline|No Ketamine|No ketamine added to anesthesia regimen
844672|NCT01250418|B1|Baseline|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
844673|NCT01250418|P2|Participant Flow|No Ketamine|No ketamine added to anesthesia regimen
844674|NCT01250418|P1|Participant Flow|Ketamine Group|ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
844675|NCT01250418|O2|Outcome|No Ketamine|No ketamine added to anesthesia regimen
844676|NCT01250418|O1|Outcome|Ketamine Group|"ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.~Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min."
844677|NCT01250418|E2|Reported Event|Ketamine Group|Ketamine group: Ketamine group: ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
844678|NCT01250418|E1|Reported Event|No Ketamine Added to Anesthesia Regimen|No ketamine added to the patients anesthesia regimen
844679|NCT01250379|B3|Baseline|Total|Total of all reporting groups
844680|NCT01250379|B2|Baseline|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844681|NCT01250379|B1|Baseline|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844682|NCT01250379|P2|Participant Flow|Chemotherapy Plus Bevacizumab (CT+BV) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 milligrams per kilogram (mg/kg), intravenously (IV), every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844683|NCT01250379|P1|Participant Flow|Chemotherapy (CT) Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844684|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844685|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
846856|NCT01242527|B3|Baseline|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
844798|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844799|NCT01250171|E3|Reported Event|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844686|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844687|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844688|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844689|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844690|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844691|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844692|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844693|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844749|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844694|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844695|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844696|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844697|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844698|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844699|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844700|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844701|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844750|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844751|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844702|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844703|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844704|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844705|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844706|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844707|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844708|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844709|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844752|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844710|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844711|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844712|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844713|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844714|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844715|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844716|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844717|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844753|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844754|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844718|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844719|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844720|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844721|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844722|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844723|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844724|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844725|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844755|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844726|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844727|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844728|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844729|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844730|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844731|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844732|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844733|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844756|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844757|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844734|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844735|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844736|NCT01250379|O2|Outcome|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844737|NCT01250379|O1|Outcome|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844738|NCT01250379|E2|Reported Event|CT+BV Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site plus bevacizumab, 15 mg/kg, IV, every 3 weeks, or 10 mg/kg, IV, every 2 weeks until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844739|NCT01250379|E1|Reported Event|CT Arm|Participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, until the maximum cumulative dose of anthracycline was reached, or end of study (24 months after randomization of the last participant). Upon second-line disease progression participants received a single-agent chemotherapy at the discretion of the investigator according to the standard of care at the investigator’s site until disease progression, unacceptable toxicity, participant request for withdrawal, or end of study. Upon subsequent disease progression participants received treatment according the standard of care of the treatment site until end of study.
844740|NCT01250184|B4|Baseline|Total|Total of all reporting groups
844741|NCT01250184|B3|Baseline|Blocking the MTP|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844742|NCT01250184|B2|Baseline|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844743|NCT01250184|B1|Baseline|Blocking the MTP Plus Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844744|NCT01250184|P3|Participant Flow|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844745|NCT01250184|P2|Participant Flow|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844746|NCT01250184|P1|Participant Flow|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844747|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844748|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844996|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844758|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844759|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844760|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844761|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844762|NCT01250184|O3|Outcome|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844763|NCT01250184|O2|Outcome|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844764|NCT01250184|O1|Outcome|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844765|NCT01250184|E3|Reported Event|Lidocaine Injection|"Blocking the myofascial trigger point (MTP) with lidocaine injection, unique dose.~Blocking the MTP: blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose."
844766|NCT01250184|E2|Reported Event|Physical Therapy|"Twelve sessions, 3 per week.~Physical therapy: Twelve sessions (3 per week)"
844767|NCT01250184|E1|Reported Event|Lidocaine Injection + Physical Therapy|"Blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program, twelve sessions, 3 per week.~blocking the MTP plus physical therapy: blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)"
844768|NCT01250171|B4|Baseline|Total|Total of all reporting groups
844769|NCT01250171|B3|Baseline|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844770|NCT01250171|B2|Baseline|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844771|NCT01250171|B1|Baseline|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844772|NCT01250171|P3|Participant Flow|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844773|NCT01250171|P2|Participant Flow|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844774|NCT01250171|P1|Participant Flow|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844775|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844776|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844777|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844778|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844779|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844780|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844781|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844782|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844783|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844784|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844785|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844786|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844787|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844788|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844789|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844790|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844791|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844792|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844793|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844794|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844795|NCT01250171|O1|Outcome|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844796|NCT01250171|O3|Outcome|Placebo|Patients received a single placebo infusion intravenously over a 2 hour period.
844797|NCT01250171|O2|Outcome|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
846857|NCT01242527|B2|Baseline|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
844800|NCT01250171|E2|Reported Event|Canakinumab 10 mg/kg|Patients received a single dose of canakinumab 10 mg/kg infused intravenously over a 2 hour period.
844801|NCT01250171|E1|Reported Event|Secukinumab 10 mg/kg|Patients received a single dose of secukinumab 10 mg/kg infused intravenously over a 2 hour period.
844802|NCT01250145|B3|Baseline|Total|Total of all reporting groups
844803|NCT01250145|B2|Baseline|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
844804|NCT01250145|B1|Baseline|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
844805|NCT01250145|P2|Participant Flow|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
844806|NCT01250145|P1|Participant Flow|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
844807|NCT01250145|O2|Outcome|Placebo Patch|"Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: placebo patch given once for at least 6 hours"
844808|NCT01250145|O1|Outcome|Active Patch|"Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks.~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
844809|NCT01250145|O6|Outcome|Part B: Placebo Patch - 24 Hours Post Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
844810|NCT01250145|O5|Outcome|Part B: Placebo Patch - 1 Hour Post Patch Removal|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
844811|NCT01250145|O4|Outcome|Part B: Placebo Patch - Prior to Patch Application|Part B: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
844812|NCT01250145|O3|Outcome|Part B: Active Patch - 24 Hours Post Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 24 hours after patch application.
844813|NCT01250145|O2|Outcome|Part B: Active Patch - 1 Hour Post Patch Removal|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores 1 hour after patch removal.
844814|NCT01250145|O1|Outcome|Part B: Active Patch - Prior to Patch Application|Part B: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks. Scores prior to patch application.
844815|NCT01250145|O2|Outcome|Placebo Patch|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
844816|NCT01250145|O1|Outcome|Active Patch|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days
844817|NCT01250145|O6|Outcome|Part A: Placebo Patch - 24 Hours Post Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
844818|NCT01250145|O5|Outcome|Part A: Placebo Patch - 1 Hour Post Patch Removal|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
844819|NCT01250145|O4|Outcome|Part A: Placebo Patch - Prior to Patch Application|Part A: a placebo patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
844820|NCT01250145|O3|Outcome|Part A: Active Patch - 24 Hours Post Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 24 hours after patch application.
844821|NCT01250145|O2|Outcome|Part A: Active Patch - 1 Hour Post Patch Removal|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores 1 hour after patch removal.
844822|NCT01250145|O1|Outcome|Part A: Active Patch - Prior to Patch Application|Part A: an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days. Scores prior to patch application.
844823|NCT01250145|E2|Reported Event|LY333334 + Placebo: Part B|"Part B:~Induction phase: Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, 4 times a week for 3 weeks~Rest phase: 2 weeks with no patch application~Challenge phase: 80 microgram active patch given once for at least 6 hours"
844824|NCT01250145|E1|Reported Event|LY333334 + Placebo: Part A|"Part A:~Both a placebo and an 80 microgram active patch will be applied to the same arm for at least 6 hours daily, test arms will be alternated daily, for 22 days"
844825|NCT01250119|B1|Baseline|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
844826|NCT01250119|P2|Participant Flow|Erlotinib 150 Milligrams Per Day (mg/Day)|During the Treatment Phase participants found to have a tumour with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until progressive disease (PD), death, unacceptable toxicity or withdrawal of consent.
844827|NCT01250119|P1|Participant Flow|Non-small-cell Lung Cancer (NSCLC) Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations.
844828|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844829|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844830|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844831|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844832|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844833|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844834|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844835|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844836|NCT01250119|O2|Outcome|EGFR Negative|All participants who tested negative for EGFR mutations were included in this group.
844837|NCT01250119|O1|Outcome|EGFR Positive|All participants who tested positive for EGFR mutations were included in this group.
844838|NCT01250119|O1|Outcome|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844839|NCT01250119|O1|Outcome|NSCLC Group|During the Diagnostic Phase participants newly diagnosed with recurrent or metastatic NSCLC were tested for EGFR exon 19 deletions or exon 21 (L858R) mutations.
844840|NCT01250119|E1|Reported Event|Erlotinib 150 mg/Day|During the Treatment Phase participants found to have a tumor with EGFR exon 19 deletion or exon 21 (L858R) mutations received erlotinib 150 mg/day as a single oral dose until PD, death, unacceptable toxicity or withdrawal of consent.
844841|NCT01250054|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
844842|NCT01250054|P2|Participant Flow|Comfilcon A /Lotrafilcon B|Comfilcon A multifocal contact lenses worn first, with lotrafilcon B multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
844843|NCT01250054|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B multifocal contact lenses worn first, with comfilcon A multifocal contact lenses worn second. Each product worn bilaterally on a daily wear basis for one week.
844844|NCT01250054|O2|Outcome|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
844845|NCT01250054|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
844846|NCT01250054|E2|Reported Event|Comfilcon A|Commercially marketed (Europe), silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
844847|NCT01250054|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, multifocal contact lenses for daily wear use worn bilaterally for one week.
844848|NCT01250002|B3|Baseline|Total|Total of all reporting groups
844849|NCT01250002|B2|Baseline|Placebo|Group B (control group) will receive the same volume of saline infusion.
844850|NCT01250002|B1|Baseline|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
844851|NCT01250002|P2|Participant Flow|Placebo|Group B (control group) will receive the same volume of saline infusion.
844852|NCT01250002|P1|Participant Flow|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
844853|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
844854|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
844855|NCT01250002|O2|Outcome|Placebo|Group B (control group) will receive the same volume of saline infusion.
844856|NCT01250002|O1|Outcome|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
844857|NCT01250002|E2|Reported Event|Placebo|Group B (control group) will receive the same volume of saline infusion.
844858|NCT01250002|E1|Reported Event|Group A (Study Group) Lidocaine|Group A (study group) Lidocaine administration
844859|NCT01249872|B7|Baseline|Total|Total of all reporting groups
844860|NCT01249872|B6|Baseline|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844861|NCT01249872|B5|Baseline|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
845015|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845016|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
844862|NCT01249872|B4|Baseline|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 ml of normal saline. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844863|NCT01249872|B3|Baseline|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intraoperatively (45 min before the estimated end of the surgery) an epidural bolus dose 2 mg of morphine. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844864|NCT01249872|B2|Baseline|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intraoperatively(45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844865|NCT01249872|B1|Baseline|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844866|NCT01249872|P6|Participant Flow|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844867|NCT01249872|P5|Participant Flow|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844868|NCT01249872|P4|Participant Flow|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844869|NCT01249872|P3|Participant Flow|GROUP C : 2 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844870|NCT01249872|P2|Participant Flow|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844871|NCT01249872|P1|Participant Flow|GROUP A : 0 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844872|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844873|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844874|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844875|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844876|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844877|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844997|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
846858|NCT01242527|B1|Baseline|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
844878|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844879|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844880|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844881|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844882|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844883|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844884|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844885|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844886|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844887|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844888|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844889|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844890|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844891|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844892|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844893|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844998|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844999|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844894|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844895|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844896|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844897|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844898|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844899|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844900|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1%LEVOBUPIVACAINE|Group B patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844901|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844902|NCT01249872|O6|Outcome|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844903|NCT01249872|O5|Outcome|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844904|NCT01249872|O4|Outcome|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844905|NCT01249872|O3|Outcome|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844906|NCT01249872|O2|Outcome|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844907|NCT01249872|O1|Outcome|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844908|NCT01249872|E6|Reported Event|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group F patients (n=16)receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844909|NCT01249872|E5|Reported Event|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Group E patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
845000|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
845001|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844910|NCT01249872|E4|Reported Event|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Group D patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844911|NCT01249872|E3|Reported Event|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group C patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844912|NCT01249872|E2|Reported Event|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Group B patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844913|NCT01249872|E1|Reported Event|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Group A patients (n=16) receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
844914|NCT01249833|B3|Baseline|Total|Total of all reporting groups
844915|NCT01249833|B2|Baseline|Standard of Care Alone|Standard of care for influenza
844916|NCT01249833|B1|Baseline|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
844917|NCT01249833|P2|Participant Flow|Standard of Care Alone|Standard of care for influenza
844918|NCT01249833|P1|Participant Flow|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
844919|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
844920|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
844921|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
844922|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
844923|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
844924|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
844925|NCT01249833|O2|Outcome|Standard of Care Alone|Standard of care for influenza
844926|NCT01249833|O1|Outcome|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
844927|NCT01249833|E2|Reported Event|Standard of Care Alone|Standard of care for influenza
844928|NCT01249833|E1|Reported Event|Oseltamivir|"Added to standard of care for influenza~Oseltamivir: Oseltamivir 75mg BID for 5 days"
844929|NCT01249664|B3|Baseline|Total|Total of all reporting groups
844930|NCT01249664|B2|Baseline|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844931|NCT01249664|B1|Baseline|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844932|NCT01249664|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844933|NCT01249664|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844934|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844935|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
845002|NCT01249417|O3|Outcome|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
846859|NCT01242527|P4|Participant Flow|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
844936|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844937|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844938|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844939|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844940|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844941|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844942|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844943|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844944|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844945|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844946|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844947|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
845003|NCT01249417|O2|Outcome|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
845004|NCT01249417|O1|Outcome|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
845005|NCT01249417|E3|Reported Event|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844948|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844949|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844950|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844951|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844952|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844953|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844954|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844955|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844956|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844957|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844958|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844959|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
845006|NCT01249417|E2|Reported Event|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
845007|NCT01249417|E1|Reported Event|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
845008|NCT01249274|B3|Baseline|Total|Total of all reporting groups
845009|NCT01249274|B2|Baseline|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
844960|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844961|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844962|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844963|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844964|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844965|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844966|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844967|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844968|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844969|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844970|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844971|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
845010|NCT01249274|B1|Baseline|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845011|NCT01249274|P2|Participant Flow|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845012|NCT01249274|P1|Participant Flow|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845013|NCT01249274|O2|Outcome|Progesterone|Progesterone: 100mgs progesterone twice daily
844972|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844973|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844974|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844975|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844976|NCT01249664|O2|Outcome|Sham Treatment First, Then Aflibercept Injection or Sham|Participant received a sham injection every 4 weeks from Week 0 to Week 20. At Week 24, participants received a single 2 mg Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844977|NCT01249664|O1|Outcome|Aflibercept Injection First, Then Aflibercept or Sham|Participants received a single 2 mg dose of Intravitreal Aflibercept Injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) at baseline (Week 0). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 44 only if the Choroidal neovascularization (CNV) persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met at a given visit, participant received a sham injection.
844978|NCT01249664|E4|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 44)|Participants who continued the sham treatment until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment were not met, participant received a sham injection. Participants were observed from Week 24 until Week 48. Participants in the safety population were at risk.
844979|NCT01249664|E3|Reported Event|Aflibercept Injection (Until Week 44)|Participants who continued the study drug until week 20 were monitored every 4 weeks and received a single 2 mg dose IAI at these visits from week 24 through week 44 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed from week 24 until week 48. Participants in the safety population were at risk.
844980|NCT01249664|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received a sham injection every 4 weeks from week 0 through week 20. Participants were observed until week 24. Participants in the safety population were at risk.
844981|NCT01249664|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg single dose of IAI at baseline (Week 20). Following this, participants were monitored every 4 weeks and received an injection at these visits up to week 20 only if the CNV persisted or recurred, i.e. protocol defined re-treatment criteria were met. If these re-treatment criteria were not met, participant received a sham injection. Participants were observed until week 24. Participants in the safety population were at risk.
844982|NCT01249651|B1|Baseline|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
844983|NCT01249651|P1|Participant Flow|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
844984|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
844985|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
844986|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
844987|NCT01249651|O1|Outcome|Arm 1 - Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
844988|NCT01249651|E1|Reported Event|Esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
844989|NCT01249417|B4|Baseline|Total|Total of all reporting groups
844990|NCT01249417|B3|Baseline|Placebo|Placebo intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844991|NCT01249417|B2|Baseline|Dysport 15 U/Kg|Dysport 15 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844992|NCT01249417|B1|Baseline|Dysport 10 U/Kg|Dysport 10 U/Kg intramuscular injection on either one or both lower limbs (2 ml per leg), single treatment.
844993|NCT01249417|P3|Participant Flow|Placebo|"Total volume to be injected per lower limb - 2ml. Either one or both lower limbs can be treated.~Placebo: I.M. injection on day 1 of a single treatment cycle."
844994|NCT01249417|P2|Participant Flow|Dysport 15 U/Kg|"15 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
844995|NCT01249417|P1|Participant Flow|Dysport 10 U/Kg|"10 U/Kg per lower limb. Either one or both lower limbs can be treated. Total volume injected, 2ml per leg.~Botulinum type A toxin (Dysport®): I.M. (in the muscle) injection on day 1 of a single treatment cycle."
845017|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845018|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845019|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845020|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845021|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845022|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845023|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845024|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845025|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845026|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845027|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845028|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845029|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845030|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845031|NCT01249274|O2|Outcome|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845032|NCT01249274|O1|Outcome|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845033|NCT01249274|E2|Reported Event|Progesterone|"100 mgs progesterone twice daily~Progesterone: 100mgs progesterone twice daily"
845034|NCT01249274|E1|Reported Event|Placebo|"Matched placebo pills to be taken twice daily~Placebo: Matched placebo pills to be taken twice daily"
845035|NCT01249261|B3|Baseline|Total|Total of all reporting groups
845036|NCT01249261|B2|Baseline|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845037|NCT01249261|B1|Baseline|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845038|NCT01249261|P2|Participant Flow|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845039|NCT01249261|P1|Participant Flow|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845040|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845041|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845042|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845043|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845044|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845045|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845046|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845047|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845048|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845049|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845050|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845051|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845052|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845053|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845054|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845055|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845056|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845057|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845058|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845059|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845060|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845061|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845062|NCT01249261|O2|Outcome|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845063|NCT01249261|O1|Outcome|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845064|NCT01249261|E2|Reported Event|Risedronate|Risedronate 5mg years 1-7, no drug year 8
845065|NCT01249261|E1|Reported Event|Placebo/Risedronate|Placebo years 1-5, Risedronate 5mg/day years 6 & 7, no drug year 8
845066|NCT01249157|B1|Baseline|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer.The first 5 patients who consent to the study will be intended for training purposes only.
845067|NCT01249157|P1|Participant Flow|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
845068|NCT01249157|O1|Outcome|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
845069|NCT01249157|E1|Reported Event|Preoperative 18FDG PEM and MRI|Female patients with recently diagnosed invasive or in situ breast cancer
845070|NCT01249131|B1|Baseline|Entire Study Population|All participants randomized to any treatment.
845094|NCT01249131|E1|Reported Event|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845071|NCT01249131|P6|Participant Flow|Treatment C First, Then Treatment B, Followed by Treatment A|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
845072|NCT01249131|P5|Participant Flow|Treatment C First, Then Treatment A, Followed by Treatment B|Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
845073|NCT01249131|P4|Participant Flow|Treatment B First, Then Treatment C, Followed by Treatment A|Treatment B first, then Treatment C, followed by Treatment A Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
845074|NCT01249131|P3|Participant Flow|Treatment B First, Then Treatment A, Followed by Treatment C|Treatment B first, then Treatment A, followed by Treatment C Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in third intervention period.
845075|NCT01249131|P2|Participant Flow|Treatment A First, Then Treatment C, Followed by Treatment B|Treatment A: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in first intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal, in second intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in third intervention period.
845076|NCT01249131|P1|Participant Flow|Treatment A First, Then Treatment B, Followed by Treatment C|Treatment A: One 20-milligram (mg) tablet of cobimetinib administered orally with 240 milliliter (mL) room temperature water after at least an 8-hour fast, in first intervention period. Treatment B: Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast, in second intervention period. Treatment C: One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard Food and Drug Administration (FDA) high-fat meal, in third intervention period. The washout period between each period was a minimum of 10 days.
845077|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
845078|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845079|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845080|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
845081|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845082|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845083|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
845084|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845085|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845086|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
845087|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845088|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845089|NCT01249131|O3|Outcome|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
845090|NCT01249131|O2|Outcome|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845091|NCT01249131|O1|Outcome|Cobimetinib One 20 mg Tablet [Fasted]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845092|NCT01249131|E3|Reported Event|Cobimetinib One 20 mg Tablet [Fed]|One 20-mg tablet of cobimetinib administered orally with 240 mL room temperature water within 30 minutes of eating a standard FDA high-fat meal.
845093|NCT01249131|E2|Reported Event|Cobimetinib Four 5 mg Capsules [Fasted]|Four 5-mg capsules of cobimetinib administered orally with 240 mL room temperature water after at least an 8-hour fast.
845631|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845095|NCT01249118|B1|Baseline|Entire Study Population|"Part 1: Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.~Part 2: Participants received single dose of GDC-0973 2 mg IV infusion and GDC-0973 20 mg oral capsules (four 5-mg capsules) in either of the two intervention periods. There was a washout period of minimum 10 days after each intervention period."
845096|NCT01249118|P3|Participant Flow|Part 2: GDC-0973 Capsules First, Then GDC-0973 IV Infusion|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in first intervention period followed by single dose of GDC-0973 2 mg IV infusion in second intervention period. There was a washout period of minimum 10 days after each intervention period.
845097|NCT01249118|P2|Participant Flow|Part 2: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 mg IV infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
845098|NCT01249118|P1|Participant Flow|Part 1: GDC-0973 IV Infusion First, Then GDC-0973 Capsules|Participants received single dose of GDC-0973 2 milligrams (mg) intravenous (IV) infusion in first intervention period followed by single dose of GDC-0973 20 mg oral capsules (four 5-mg capsules) in second intervention period. There was a washout period of minimum 10 days after each intervention period.
845099|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845100|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845101|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845102|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845103|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845104|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845105|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845106|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845107|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845108|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845109|NCT01249118|O1|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845110|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845111|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845112|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845113|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845114|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845115|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845116|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845117|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845118|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845119|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845120|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845121|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845122|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845123|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845124|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845125|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845632|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
845126|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845127|NCT01249118|O2|Outcome|GDC-0973 20 mg Oral|Participants received single dose of GDC-0973 20 mg oral capsules (four 5-mg capsule) in either of the intervention periods in part 2 of the study.
845128|NCT01249118|O1|Outcome|GDC-0973 2 mg IV|Participants received single dose of GDC-0973 2 mg IV infusion in either of the intervention periods in part 2 of the study.
845129|NCT01249118|E2|Reported Event|GDC-0973 20 mg Oral|Participants received GDC-0973 20 mg oral capsules (four 5-mg capsule) in either intervention period in part 1 and part 2 of the study.
845130|NCT01249118|E1|Reported Event|GDC-0973 2 mg IV|Participants received GDC-0973 2 mg IV infusion in either intervention period in part 1 and part 2 of the study.
845131|NCT01249092|B1|Baseline|Pentoxifylline 400 mg/d|All patients received same intervention.
845132|NCT01249092|P1|Participant Flow|Pentoxifylline 400 mg/d|All patients received same intervention.
845133|NCT01249092|O1|Outcome|Pentoxifylline 400 mg/d|Descriptive information only of small open label pilot. Small patient number not amenable for any valid statistical comparisons regarding side effects. All patients received same intervention. No SAEs occurred.
845134|NCT01249092|O1|Outcome|Change in Serum TIMP-1 (Tissue Inhibitor metalloproteinase1)|
845135|NCT01249092|O1|Outcome|Change in Alkaline Phosphatase After Pentoxifylline Therapy|
845136|NCT01249092|E1|Reported Event|Pentoxifylline 400 mg/d|All patients received same intervention.
845137|NCT01248949|B6|Baseline|Total|Total of all reporting groups
845138|NCT01248949|B5|Baseline|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845139|NCT01248949|B4|Baseline|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845140|NCT01248949|B3|Baseline|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845141|NCT01248949|B2|Baseline|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845142|NCT01248949|B1|Baseline|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845143|NCT01248949|P5|Participant Flow|MEDI3617 + CARBOPLATIN/ PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845144|NCT01248949|P4|Participant Flow|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845145|NCT01248949|P3|Participant Flow|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845146|NCT01248949|P2|Participant Flow|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845147|NCT01248949|P1|Participant Flow|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845148|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845149|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845150|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845151|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845152|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845153|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845154|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845179|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845383|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845155|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845156|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845157|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845158|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845159|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845160|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845161|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845162|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845163|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845164|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845165|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845166|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845167|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845168|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845169|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845170|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845171|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845172|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845173|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845174|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845175|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845176|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845177|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845178|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845180|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845181|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845182|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845183|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845184|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845185|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845186|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845187|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845188|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845189|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845190|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845191|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845192|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845193|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845194|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845195|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845196|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845197|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845198|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845199|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845200|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845201|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845202|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845203|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845204|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845205|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845206|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845207|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845208|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845209|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845210|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845211|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845212|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845213|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845214|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845215|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845216|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845217|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845218|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845219|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845220|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845221|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845222|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845223|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845224|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845225|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845226|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845227|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845228|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845229|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845230|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845231|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845232|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845233|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845234|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845235|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845236|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845237|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845238|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845239|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845240|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845241|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845242|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845243|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845244|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845245|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845246|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845247|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845248|NCT01248949|O5|Outcome|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845249|NCT01248949|O4|Outcome|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845250|NCT01248949|O3|Outcome|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845251|NCT01248949|O2|Outcome|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845252|NCT01248949|O1|Outcome|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845253|NCT01248949|E5|Reported Event|MEDI3617 + CARBOPLATIN/PACLITAXEL TOTAL|Participants received MEDI3617 with carboplatin and paclitaxel on Day 1 via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons. Each cycle consists of 21 days.
845254|NCT01248949|E4|Reported Event|MEDI3617 + PACLITAXEL TOTAL|Participants received MEDI3617 on Days 1 and 15 with paclitaxel on Days 1, 8, and 15 via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons. Each cycle consists of 28 days.
845255|NCT01248949|E3|Reported Event|MEDI3617 + BEVACIZUMAB Q2W TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 2 weeks (Q2W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 28 days.
845256|NCT01248949|E2|Reported Event|MEDI3617 + BEVACIZUMAB Q3W ESCALATION TOTAL|Participants received MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845257|NCT01248949|E1|Reported Event|MEDI3617 SINGLE AGENT TOTAL|Participants received MEDI3617 via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
845258|NCT01248936|B1|Baseline|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
845259|NCT01248936|P1|Participant Flow|Overall Trial|Participants received vemurafenib 960 milligram (mg) orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor.
845260|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
845261|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
845262|NCT01248936|O1|Outcome|Overall Trial|Participants received Vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, Unmanageable toxicity most probably attributable to Vemurafenib, withdrawal of consent, and Study termination by the Sponsor
845263|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
845264|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
845265|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
845266|NCT01248936|O1|Outcome|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
845267|NCT01248936|E1|Reported Event|Overall Trial|Participants received vemurafenib 960 mg orally two times a day for up to one year. Participants were treated until disease progression, unmanageable toxicity most probably attributable to vemurafenib, withdrawal of consent, and study termination by the sponsor
845268|NCT01248884|B4|Baseline|Total|Total of all reporting groups
845269|NCT01248884|B3|Baseline|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845270|NCT01248884|B2|Baseline|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845271|NCT01248884|B1|Baseline|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845272|NCT01248884|P3|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845273|NCT01248884|P2|Participant Flow|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845274|NCT01248884|P1|Participant Flow|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845275|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845276|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845277|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845278|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexaTM vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexaTM and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845279|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845280|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845281|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845282|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845283|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845284|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845285|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845286|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845287|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845288|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845289|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845290|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845291|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845292|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845293|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
846860|NCT01242527|P3|Participant Flow|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
845294|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845295|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845296|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845297|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845298|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845299|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845300|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845301|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845302|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845303|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845304|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845305|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845306|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845307|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845308|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845309|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845310|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845311|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845312|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
846861|NCT01242527|P2|Participant Flow|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
845313|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845314|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845315|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845316|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845317|NCT01248884|O3|Outcome|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845318|NCT01248884|O2|Outcome|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845319|NCT01248884|O1|Outcome|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845320|NCT01248884|E3|Reported Event|Infanrix Hexa Group|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively .
845321|NCT01248884|E2|Reported Event|GSK217744 Group 2|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845322|NCT01248884|E1|Reported Event|GSK217744 Group 1|Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
845323|NCT01248793|B3|Baseline|Total|Total of all reporting groups
845324|NCT01248793|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
845325|NCT01248793|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
845326|NCT01248793|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
845327|NCT01248793|P1|Participant Flow|Group I: Placebo|Placebo SC injections every 4 weeks from Week 0 to Week 20(unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape
845328|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
845329|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
845330|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
845331|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
845332|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
845333|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
845334|NCT01248793|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20
845335|NCT01248793|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); Golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape
845336|NCT01248793|E2|Reported Event|Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48
845337|NCT01248793|E1|Reported Event|Placebo -> Golimumab 50 mg|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escape to receive Golimumab 50 mg SC injection every 4 weeks from Week 16 to Week 20; or Placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive Golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48
845338|NCT01248780|B3|Baseline|Total|Total of all reporting groups
845339|NCT01248780|B2|Baseline|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845633|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845340|NCT01248780|B1|Baseline|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845341|NCT01248780|P2|Participant Flow|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845342|NCT01248780|P1|Participant Flow|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48 if early escape; golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48 if not early escape. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845343|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845344|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845345|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845346|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845347|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845348|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845349|NCT01248780|O2|Outcome|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 20; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845350|NCT01248780|O1|Outcome|Group I: Placebo + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 20 (unless early escape at Week 16); golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 20 if early escape; In addition, subjects received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845351|NCT01248780|E2|Reported Event|Group II: Golimumab 50 mg + MTX|Golimumab 50 mg SC injections every 4 weeks from Week 0 to Week 48; In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845352|NCT01248780|E1|Reported Event|Group I: Placebo + MTX -> Golimumab 50 mg + MTX|Placebo SC injections every 4 weeks from Week 0 to Week 12 and early escaped to receive golimumab 50 mg SC injections every 4 weeks from Week 16 to Week 48; or placebo SC injections every 4 weeks from Week 0 to Week 20 and crossed over to receive golimumab 50 mg SC injections every 4 weeks from Week 24 to Week 48. In addition, participants received a stable dose of methotrexate (MTX) capsules (>= 7.5 mg/week and <= 20 mg/week).
845353|NCT01248728|B3|Baseline|Total|Total of all reporting groups
845354|NCT01248728|B2|Baseline|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
845355|NCT01248728|B1|Baseline|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
845356|NCT01248728|P2|Participant Flow|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
845357|NCT01248728|P1|Participant Flow|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
845358|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
845359|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
845382|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
845634|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
845360|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
845361|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
845362|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
845363|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
845364|NCT01248728|O2|Outcome|Placebo|Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor.
845365|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP. If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group. The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor.
845366|NCT01248728|O2|Outcome|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
845367|NCT01248728|O1|Outcome|Omega-3 Fatty Acids|"Participants started at 0.75 g of EPA + DHA (1.875 ml once a day) of liquid formulation of NutraSea HP.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The NutraSea HP formulation is a naturally derived fish oil that is extracted, isolated, and processed to contain EPA/DHA in the ratio of 3:1. It has a lemon flavor."
845368|NCT01248728|E2|Reported Event|Placebo|"Participants started at 0.75 g (1.875 ml once a day) of liquid formulation of placebo.~If this was well tolerated, the dose was doubled to 1.5 g (3.5 ml) after 2 weeks, as per Health Canada guidelines for maximum dose for this age group.~The placebo had the same physical characteristics as the medication (NutraSea HP) but contained refined olive oil and medium chain triglycerides. The placebo has a lemon flavor."
845369|NCT01248728|E1|Reported Event|Omega-3 Fatty Acids|"Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.~Omega-3 Fatty Acids: Children will be administered 3.75ml of the liquid formulation of NutraSea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process."
845370|NCT01248468|B4|Baseline|Total|Total of all reporting groups
845371|NCT01248468|B3|Baseline|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845372|NCT01248468|B2|Baseline|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845373|NCT01248468|B1|Baseline|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
845374|NCT01248468|P3|Participant Flow|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845375|NCT01248468|P2|Participant Flow|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845376|NCT01248468|P1|Participant Flow|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
845377|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845378|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845379|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
845380|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845381|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845384|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845385|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
845386|NCT01248468|O3|Outcome|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845387|NCT01248468|O2|Outcome|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845388|NCT01248468|O1|Outcome|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
845389|NCT01248468|E3|Reported Event|Placebo|1 placebo tablet matching sumatriptan 100mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845390|NCT01248468|E2|Reported Event|Sumatriptan (100 mg)|1 tablet containing sumatriptan 100 mg and 2 placebo tablets matching acetaminophen 250 mg, aspirin 250 mg and caffeine 65 mg tablets
845391|NCT01248468|E1|Reported Event|Aspirin, Acetaminophen, and Caffeine|2 tablets, each containing acetaminophen 250 mg, aspiring 250 mg, caffeine 65 mg and 1 placebo tablet matching sumatriptan 100 mg tablets
845392|NCT01248455|B1|Baseline|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
845393|NCT01248455|P1|Participant Flow|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
845394|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
845395|NCT01248455|O1|Outcome|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
845396|NCT01248455|E1|Reported Event|Anti-KIR in Smoldering Multiple Myeloma Patients|"Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles~(Anti-KIR): Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles"
845397|NCT01248364|B5|Baseline|Total|Total of all reporting groups
845398|NCT01248364|B4|Baseline|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845399|NCT01248364|B3|Baseline|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845400|NCT01248364|B2|Baseline|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845401|NCT01248364|B1|Baseline|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845402|NCT01248364|P4|Participant Flow|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845403|NCT01248364|P3|Participant Flow|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845404|NCT01248364|P2|Participant Flow|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845405|NCT01248364|P1|Participant Flow|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845406|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845407|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845408|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845409|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845410|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845411|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845412|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845413|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845414|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845415|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845416|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845417|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845418|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845419|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845420|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845421|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845422|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845423|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845424|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845425|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845426|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845427|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845428|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845429|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845430|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845431|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845432|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845433|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845434|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845435|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845436|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845437|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845438|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845439|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845440|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845441|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845442|NCT01248364|O4|Outcome|Healthy Subjects|Healthy subjects received a single dose of empagliflozin (empa) 25mg, in tablet form.
845443|NCT01248364|O3|Outcome|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845444|NCT01248364|O2|Outcome|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845445|NCT01248364|O1|Outcome|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845446|NCT01248364|E4|Reported Event|Healthy Subjects|Healthy subjects received empagliflozin (empa) 25mg tablet once daily for 28 days.
845447|NCT01248364|E3|Reported Event|Impaired Glucose Tolerance|Patients diagnosed with impaired glucose tolerance (IGT) according to American Diabetes Association (ADA) guidelines. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845448|NCT01248364|E2|Reported Event|T2DM Metformin|Patients diagnosed with type 2 diabetes mellitus (T2DM) who are on stable dose of metformin of at least 1500 mg per day, for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845449|NCT01248364|E1|Reported Event|T2DM Naive|Patients diagnosed with type 2 diabetes mellitus (T2DM) who have not been treated with any antihyperglycemic therapy for the last 12 weeks prior to the study. Patients received empagliflozin (empa) 25mg tablet once daily for 28 days.
845450|NCT01248221|B3|Baseline|Total|Total of all reporting groups
845451|NCT01248221|B2|Baseline|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845452|NCT01248221|B1|Baseline|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845453|NCT01248221|P2|Participant Flow|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845454|NCT01248221|P1|Participant Flow|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845455|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845456|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845457|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845458|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845459|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845460|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845461|NCT01248221|O2|Outcome|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845504|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
845505|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
845462|NCT01248221|O1|Outcome|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and Technetium-99m (99mTc) sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845463|NCT01248221|E2|Reported Event|Dyspeptic Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845464|NCT01248221|E1|Reported Event|Healthy Subjects|The subject will consume the test meal containing [13C]-Spirulina platensis and 99mTc sulfur colloid, after which gastric emptying will be assessed simultaneously by scintigraphy and breath tests. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
845465|NCT01248130|B3|Baseline|Total|Total of all reporting groups
845466|NCT01248130|B2|Baseline|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845467|NCT01248130|B1|Baseline|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845468|NCT01248130|P2|Participant Flow|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845469|NCT01248130|P1|Participant Flow|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845470|NCT01248130|O2|Outcome|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845471|NCT01248130|O1|Outcome|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845472|NCT01248130|E2|Reported Event|Placebo (Sugar Pill)|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845473|NCT01248130|E1|Reported Event|Omega-3 Fatty Acid Treatment|Omega-3 Fatty Acid: Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
845474|NCT01248065|B3|Baseline|Total|Total of all reporting groups
845475|NCT01248065|B2|Baseline|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
845476|NCT01248065|B1|Baseline|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
845477|NCT01248065|P2|Participant Flow|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
845478|NCT01248065|P1|Participant Flow|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
845479|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
845480|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
845481|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
845482|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
845483|NCT01248065|O2|Outcome|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
845484|NCT01248065|O1|Outcome|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
845485|NCT01248065|E2|Reported Event|Ciclesonide + Vitamin D|"Vitamin D3: vitamin D (100,000 IU loading dose followed by 4,000 IU/day)~Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)"
845486|NCT01248065|E1|Reported Event|Ciclesonide + Placebo|Ciclesonide: Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
845487|NCT01248013|B1|Baseline|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
845488|NCT01248013|P1|Participant Flow|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
845489|NCT01248013|O1|Outcome|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
845490|NCT01248013|E1|Reported Event|Group Hypnotherapy for Irritable Bowel Syndrome|IBS subjects, in groups of 3 to 8 participants, received a specific gut focused hypnotherapy protocol. Meetings were bi-weekly, seven in all, and each meeting was 45 minutes in length. CD's were distributed for use at home between meetings.
845491|NCT01247974|B3|Baseline|Total|Total of all reporting groups
845492|NCT01247974|B2|Baseline|Control|No closure of pericardium
845493|NCT01247974|B1|Baseline|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
845494|NCT01247974|P2|Participant Flow|Control|Pericardium is not closed
845495|NCT01247974|P1|Participant Flow|CorMatrix® ECM®|CorMatrix® ECM® for Pericardial Closure: Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
845496|NCT01247974|O2|Outcome|Control|No Pericardial Closure
845497|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
845498|NCT01247974|O2|Outcome|Control|No Pericardial Closure
845499|NCT01247974|O1|Outcome|CorMatrix ECM for Pericardial Closure|Pericardial closure with CorMatrix ECM
845500|NCT01247974|E2|Reported Event|Control|Pericardium is not closed
845501|NCT01247974|E1|Reported Event|CorMatrix ECM|CorMatrix ECM for Pericardial Closure
845502|NCT01247922|B1|Baseline|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
845503|NCT01247922|P1|Participant Flow|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
845628|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
845506|NCT01247922|O1|Outcome|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
845507|NCT01247922|E1|Reported Event|Erlotinib|Participants who received erlotinib in a continuous oral dose of 85 mg/m^2 per day until dose modification, interruption or study discontinuation occurred.
845508|NCT01247675|B5|Baseline|Total|Total of all reporting groups
845509|NCT01247675|B4|Baseline|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845510|NCT01247675|B3|Baseline|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
845511|NCT01247675|B2|Baseline|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845512|NCT01247675|B1|Baseline|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
845513|NCT01247675|P4|Participant Flow|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: subcutaneous, daily injection of Omnitrope equivalent to 0.04 mg/kg/wk over 4 weeks. Prior to randomization, study subjects entered a wash out period of 14 to 21 days following cessation of daily growth hormone therapy.
845514|NCT01247675|P3|Participant Flow|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.08 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
845515|NCT01247675|P2|Participant Flow|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.04 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
845516|NCT01247675|P1|Participant Flow|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): subcutaneous, weekly injection equivalent to 0.02 mg hGH/kg/wk over 4 weeks. Prior to randomization, study subjects entered a 14 to 21 day wash out period following cessation of daily growth hormone therapy.
845517|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845518|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
845519|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk
845520|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
845521|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845522|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
845523|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845524|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
845525|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845526|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
845527|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845528|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
845529|NCT01247675|O4|Outcome|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845530|NCT01247675|O3|Outcome|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk for 4 weeks
845531|NCT01247675|O2|Outcome|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845532|NCT01247675|O1|Outcome|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
845533|NCT01247675|E4|Reported Event|Omnitrope, 0.04 mg hGH/kg/wk|Human Growth Hormone: s.c., daily injection of Omnitrope equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845534|NCT01247675|E3|Reported Event|ACP-001, 0.08 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.08 mg hGH/kg/wk
845535|NCT01247675|E2|Reported Event|ACP-001, 0.04 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.04 mg hGH/kg/wk for 4 weeks
845536|NCT01247675|E1|Reported Event|ACP-001, 0.02 mg hGH/kg/wk|ACP-001 (TransCon hGH): s.c., weekly injection equivalent to 0.02 mg hGH/kg/wk for 4 weeks
845537|NCT01247428|B1|Baseline|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845538|NCT01247428|P1|Participant Flow|MiStent SES|The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845539|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845540|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845541|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845542|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845543|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
846867|NCT01242527|E4|Reported Event|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
845544|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845545|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845546|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845547|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845548|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845549|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845550|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845551|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845552|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845553|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845554|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845555|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845556|NCT01247428|O1|Outcome|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845557|NCT01247428|E1|Reported Event|MiStent SES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
845558|NCT01247285|B3|Baseline|Total|Total of all reporting groups
845559|NCT01247285|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845560|NCT01247285|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845561|NCT01247285|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845562|NCT01247285|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Hydrochloride Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845563|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
845564|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
845565|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
845566|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
845567|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
845568|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
845569|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
845570|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
845571|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
845572|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
845573|NCT01247285|O2|Outcome|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in first either period.
845574|NCT01247285|O1|Outcome|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
845575|NCT01247285|E2|Reported Event|Prozac® Weekly (Reference)|90 mg Prozac® Weekly Capsules reference product dosed in either period.
845576|NCT01247285|E1|Reported Event|Fluoxetine Hydrochloride (Test)|90 mg Fluoxetine Hydrochloride Capsules test product dosed in either period.
845577|NCT01247272|B3|Baseline|Total|Total of all reporting groups
845578|NCT01247272|B2|Baseline|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845579|NCT01247272|B1|Baseline|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845580|NCT01247272|P2|Participant Flow|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845581|NCT01247272|P1|Participant Flow|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845582|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845629|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845583|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845584|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845585|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845586|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845587|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845588|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845589|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845590|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845591|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845592|NCT01247272|O2|Outcome|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845593|NCT01247272|O1|Outcome|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845594|NCT01247272|E2|Reported Event|Prozac® Weekly (Reference) First|90 mg Prozac® Weekly Capsules reference product dosed in first period followed by 90 mg Fluoxetine Hydrochloride Capsules test product dosed in the second period.
845595|NCT01247272|E1|Reported Event|Fluoxetine Hydrochloride (Test) First|90 mg Fluoxetine Capsules test product dosed in first period followed by 90 mg Prozac® Weekly Capsules reference product dosed in the second period.
845596|NCT01247220|B3|Baseline|Total|Total of all reporting groups
845597|NCT01247220|B2|Baseline|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
845598|NCT01247220|B1|Baseline|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
845599|NCT01247220|P2|Participant Flow|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
845600|NCT01247220|P1|Participant Flow|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
845601|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
845602|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
845603|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
845604|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
845605|NCT01247220|O2|Outcome|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
845606|NCT01247220|O1|Outcome|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
845607|NCT01247220|E2|Reported Event|Ranibizumab|"Ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg"
845608|NCT01247220|E1|Reported Event|Peripheral Laser + Ranibizumab|"Angiography-directed peripheral laser + ranibizumab~Ranibizumab: Intravitreal Ranibizumab 0.5 mg~Peripheral Laser: Angiography-directed peripheral laser"
845609|NCT01247090|B4|Baseline|Total|Total of all reporting groups
845610|NCT01247090|B3|Baseline|Placebo|No Dose - Placebo Comparator
845611|NCT01247090|B2|Baseline|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
845612|NCT01247090|B1|Baseline|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
845613|NCT01247090|P3|Participant Flow|Placebo|No Dose - Placebo Comparator
845614|NCT01247090|P2|Participant Flow|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
845615|NCT01247090|P1|Participant Flow|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
845616|NCT01247090|O3|Outcome|Placebo|No Dose - Placebo Comparator
845617|NCT01247090|O2|Outcome|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
845618|NCT01247090|O1|Outcome|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
845619|NCT01247090|E3|Reported Event|Placebo|No Dose - Placebo Comparator
845620|NCT01247090|E2|Reported Event|Low Dose|Low Dose: Active Comparator 0.30 mU per kg per minute
845621|NCT01247090|E1|Reported Event|Very Low Dose|Very Low Dose: Active Comparator 0.15 mU per kg per minute
845622|NCT01247064|B3|Baseline|Total|Total of all reporting groups
845623|NCT01247064|B2|Baseline|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845624|NCT01247064|B1|Baseline|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
845625|NCT01247064|P2|Participant Flow|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845626|NCT01247064|P1|Participant Flow|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
845627|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845635|NCT01247064|O2|Outcome|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845636|NCT01247064|O1|Outcome|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
845637|NCT01247064|E2|Reported Event|Nebulized 0.9% Normal Saline|Nebulized 0.9% Normal Saline: 4 mL of 0.9% nebulized normal saline once
845638|NCT01247064|E1|Reported Event|Nebulized 3% Saline|Nebulized 3% saline: 4 mL of nebulized 3% saline once
845639|NCT01246999|B5|Baseline|Total|Total of all reporting groups
845640|NCT01246999|B4|Baseline|LAIV - TIV|LAIV will be given followed by TIV 28 days later
845641|NCT01246999|B3|Baseline|TIV - TIV|TIV will be given followed by TIV 28 days later
845642|NCT01246999|B2|Baseline|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845643|NCT01246999|B1|Baseline|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845644|NCT01246999|P4|Participant Flow|TIV - TIV|TIV will be given IM followed by TIV IM
845645|NCT01246999|P3|Participant Flow|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
845646|NCT01246999|P2|Participant Flow|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845647|NCT01246999|P1|Participant Flow|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845648|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
845649|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
845650|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845651|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845652|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
845653|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
845654|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845655|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845656|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
845657|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
845658|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845659|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845660|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
845661|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
845662|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845663|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845664|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
845665|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
845666|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
846091|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
845866|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845667|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845668|NCT01246999|O4|Outcome|TIV - TIV|TIV will be given IM followed by TIV IM
845669|NCT01246999|O3|Outcome|LAIV - TIV|LAIV will be given intranasally followed by TIV intramuscularly
845670|NCT01246999|O2|Outcome|TIV - LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845671|NCT01246999|O1|Outcome|LAIV - LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845672|NCT01246999|O3|Outcome|All First Dose Live Vaccine|All subjects who received LAIV as a first dose
845673|NCT01246999|O2|Outcome|Seasonal Influenza Vaccine (TIV-LAIV)|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845674|NCT01246999|O1|Outcome|Trivalent Seasonal Live Attenuated Influenza Vaccine|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845675|NCT01246999|E4|Reported Event|TIV-TIV|TIV will be given IM followed by IV IM
845676|NCT01246999|E3|Reported Event|LAIV-TIV|LAIV will be given intranasally followed by TIV intramuscularly
845677|NCT01246999|E2|Reported Event|TIV-LAIV|"TIV will be given in a dose of .25mg 2 years to 36 months of age or .5 ml ages 37 months to 9 years intramuscularly followed by LAIV given in a dose of .2 ml intranasally 28 days later~Seasonal Influenza Vaccine TIV/LAIV: TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later"
845678|NCT01246999|E1|Reported Event|LAIV-LAIV|"LAIV 0.2 ml will be given intranasally followed by LAIV 0.2 mg given intranasally 28 days later~Trivalent Seasonal Live attenuated Influenza vaccine: 0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days"
845679|NCT01246973|B3|Baseline|Total|Total of all reporting groups
845680|NCT01246973|B2|Baseline|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
845681|NCT01246973|B1|Baseline|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
845682|NCT01246973|P2|Participant Flow|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
845683|NCT01246973|P1|Participant Flow|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
845684|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
845685|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
845686|NCT01246973|O2|Outcome|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
845687|NCT01246973|O1|Outcome|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
845688|NCT01246973|E2|Reported Event|Placebo|"4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week~Placebo: 4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week"
845689|NCT01246973|E1|Reported Event|Curcumin|"4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week~Curcumin: 4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week"
845690|NCT01246960|B3|Baseline|Total|Total of all reporting groups
845691|NCT01246960|B2|Baseline|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845692|NCT01246960|B1|Baseline|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845693|NCT01246960|P2|Participant Flow|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 mg/m^2~Leucovorin 400 mg/m^2~5-FU 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845694|NCT01246960|P1|Participant Flow|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 milligrams per kilogram (mg/kg) intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering modified FOLFOX6 (mFOLFOX6).~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin 85 milligrams per square meter (mg/m^2)~Leucovorin 400 mg/m^2~5-Fluorouracil (5-FU) 400 mg/m^2 bolus~5-FU 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845695|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845696|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845697|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer's instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845698|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845699|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845700|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845701|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845702|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845703|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845704|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845865|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845705|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845706|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845707|NCT01246960|O2|Outcome|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845708|NCT01246960|O1|Outcome|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845709|NCT01246960|E2|Reported Event|Placebo and mFOLFOX6|"Placebo: intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845710|NCT01246960|E1|Reported Event|Ramucirumab and mFOLFOX6|"Ramucirumab: 8 mg/kg intravenous infusion administered on Day 1 of each cycle (14 days/cycle). In Cycles 1 and 2, there was a 1-hour observation prior to administering mFOLFOX6.~mFOLFOX6: Administered intravenously per manufacturer’s instructions for each drug substance on Day 1 of each cycle (14 days/cycle).~Oxaliplatin: 85 mg/m^2~Leucovorin: 400 mg/m^2~5-FU: 400 mg/m^2 bolus~5-FU: 2400 mg/m^2 continuous given over 46-48 hours~Participants received study treatment every 2 weeks until disease progression, unacceptable toxicity, or another withdrawal criterion was met."
845711|NCT01246791|B1|Baseline|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845712|NCT01246791|P1|Participant Flow|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845713|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845714|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845715|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845716|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845717|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845718|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845719|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845720|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845721|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845722|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845723|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845724|NCT01246791|O1|Outcome|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845725|NCT01246791|E1|Reported Event|NPC-01|"Single oral administration of NPC-01~NPC-01: NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition"
845726|NCT01246713|B1|Baseline|All Study Participants|All study participants received a 15mg/kg dose of a solid acetaminophen formulation and a 15mg/kg dose of a liquid acetaminophen formulation separated by at least a 2 week washout period.
845797|NCT01245764|P2|Participant Flow|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845727|NCT01246713|P2|Participant Flow|Liquid Acetaminophen First, Then Solid Acetaminophen|Study participants randomized to receive liquid formulation first. They received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
845728|NCT01246713|P1|Participant Flow|Solid Acetaminophen First, Then Liquid Acetaminophen|Study participants randomized to receive solid formulation first. They received a 15mg/kg dose of a solid acetaminophen formulation for pharmacokinetic sampling on first study day, then had at least a 2 week washout period, then received a 15mg/kg dose of a liquid acetaminophen formulation for pharmacokinetic sampling on subsequent study day.
845729|NCT01246713|O2|Outcome|Acetaminophen Liquid Formulation|Subjects in this arm will receive a 15mg/kg dose of a liquid acetaminophen formulation. Results for APAP-cysteinate metabolite
845730|NCT01246713|O1|Outcome|Acetaminophen Solid Formulation|Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation. Results for APAP-cysteinate metabolite
845731|NCT01246713|E2|Reported Event|Liquid Acetaminophen First, Then Solid Acetaminophen|Participants in arm Liquid Acetaminophen First: received a single 15mg/kg dose of a liquid acetaminophen formulation, and then a 15mg/kg dose of a solid acetaminophen formulation after a 2 week washout period.
845732|NCT01246713|E1|Reported Event|Solid Acetaminophen First, Then Liquid Acetaminophen|Participants in arm Solid Acetaminophen First: received a single 15mg/kg dose of a solid acetaminophen formulation first, and then a 15mg/kg dose of a liquid acetaminophen formulation after a 2 week washout period.
845733|NCT01246479|B1|Baseline|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
845734|NCT01246479|P1|Participant Flow|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 has given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
845735|NCT01246479|O1|Outcome|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
845736|NCT01246479|E1|Reported Event|No Treatment|"subjects will be followed up on immunity (analysis of blood samples) and safety~Blood draw: blood draw at Month 12, Month 24 and Month 36.~IC51 was given in the parent study IC51-322: No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322."
845737|NCT01246349|B3|Baseline|Total|Total of all reporting groups
845738|NCT01246349|B2|Baseline|Control (Social Skills Training)|"The control group received social skills training in place of Motivational Interviewing (MI). The social skills training was provided by a therapist who was not trained in MI to avoid cross-contamination.~The social skills training provided was a standardized and manualized treatment, developed and validated for children and adolescents. As part of this training, the interventionist offered advice and clients were assigned specific tasks to work on. No consideration of clients’ readiness to change was made in this group."
845739|NCT01246349|B1|Baseline|Treatment Group (Motivational Interviewing)|"The treatment group received Motivational Interviewing (MI), which is a client-centered, directive method of therapy aimed at enhancing a client’s intrinsic motivation to change by exploring and resolving ambivalence.~MI utilizes strategies to guide the patient, as opposed to offering advice or focusing on accomplishing specific goals. For example, using reflective listening and shared decision making are common within the MI approach.~Six individual MI sessions, approximately 30 minutes in length each, were provided by a trained clinical psychology doctoral student."
845740|NCT01246349|P2|Participant Flow|Treatment/Experimental Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
845741|NCT01246349|P1|Participant Flow|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
845742|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
845795|NCT01245764|P4|Participant Flow|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
845863|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845743|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
845744|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
845745|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
845746|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
845747|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
845748|NCT01246349|O2|Outcome|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
845749|NCT01246349|O1|Outcome|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
845750|NCT01246349|E2|Reported Event|Motivational Interviewing Group|"The Treatment group received Motivational Interviewing (MI). MI is a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.~A clinical psychology doctoral student trained in MI administered the intervention over the course of 6 months to participants assigned to the treatment group. The MI intervention comprised six individual MI treatment sessions, each approximately 30 minutes in length."
845751|NCT01246349|E1|Reported Event|Control Group|"The control group received social skills training in place of motivational interviewing, conducted over 6 months by an interventionist not trained in MI to avoid cross-contamination.~The social skills interventionist used a standardized treatment manual, developed and validated for children and adolescents. The social skills interventionist offered advice (as opposed to eliciting ideas from the client, as is the case with MI) and clients were assigned goals to work on without specific regard for the clients’ readiness to change. Sessions were based around finding appropriate ways to navigate typical social situations (for example, how to negotiate with parents, how to manage emotions or how to make friends)."
845752|NCT01246258|B1|Baseline|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
845753|NCT01246258|P1|Participant Flow|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
845754|NCT01246258|O1|Outcome|Test Group|"Standard tests of balance function~Vestibular evoked myogenic potentials (VEMPs): Standard test of balance function~Utricular centrifugation test: Standard test of balance function"
845755|NCT01246258|O1|Outcome|Test Group|VEMPs
845756|NCT01246258|E1|Reported Event|Test Group|Utricular centrifugation and VEMPs: Standard tests of balance function
845796|NCT01245764|P3|Participant Flow|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
846868|NCT01242527|E3|Reported Event|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
845757|NCT01246206|B1|Baseline|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845758|NCT01246206|P1|Participant Flow|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845759|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845760|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845761|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845762|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845763|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845764|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845765|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845766|NCT01246206|O1|Outcome|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845864|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845767|NCT01246206|E1|Reported Event|Tacrolimus and Thymoglobulin|"Tacrolimus and Thymoglobulin, as Graft-versus-Host-Disease Prophylaxis~Tacrolimus and Thymoglobulin: Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
845768|NCT01246076|B1|Baseline|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845769|NCT01246076|P1|Participant Flow|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845770|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845771|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845772|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845773|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845774|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845775|NCT01246076|O1|Outcome|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845776|NCT01246076|E1|Reported Event|Lenalidomide|"Lenalidomide 50 mg/day for two 28 day cycles.~Patients who have bone marrow aplasia as defined by a cellularity of <10% will be observed till counts recover. If patients do not progress following 2 cycles of HD lenalidomide, they will receive low dose lenalidomide 10 mg daily for 12 cycles."
845777|NCT01246011|B4|Baseline|Total|Total of all reporting groups
845778|NCT01246011|B3|Baseline|Heparin PF4 Antibody Negative|
845779|NCT01246011|B2|Baseline|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
845780|NCT01246011|B1|Baseline|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
845781|NCT01246011|P3|Participant Flow|Heparin PF4 Antibody Negative|
845782|NCT01246011|P2|Participant Flow|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
845783|NCT01246011|P1|Participant Flow|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
845784|NCT01246011|O3|Outcome|Heparin PF4 Antibody Negative|
845785|NCT01246011|O2|Outcome|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
845786|NCT01246011|O1|Outcome|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
845787|NCT01246011|E3|Reported Event|Heparin PF4 Antibody Negative|
845788|NCT01246011|E2|Reported Event|Heparin PF4 Antibody Positive no Drug|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive no medication
845789|NCT01246011|E1|Reported Event|Heparin PF4 Antibody Positive -Drug (Argatroban and Warfarin)|Post-CABG heparin PF4 antibody positive with no signs or symptoms of HIT randomized to receive argatroban and warfarin
845790|NCT01245764|B5|Baseline|Total|Total of all reporting groups
845791|NCT01245764|B4|Baseline|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
845792|NCT01245764|B3|Baseline|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845793|NCT01245764|B2|Baseline|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845794|NCT01245764|B1|Baseline|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845798|NCT01245764|P1|Participant Flow|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845799|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845800|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845801|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845802|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845803|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845804|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845805|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
845806|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
845807|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B. Safety evaluation continued to Month 7 of study Phase B (total study duration up to 19 months)
845808|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation will continue to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845809|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845810|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Immunogenicity was assessed at Month 7 of study Phase A and safety evaluation continued to Month 12 (total study duration up to 12 months). Participants did not continue to study Phase B.
845811|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845812|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845813|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845814|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845815|NCT01245764|O4|Outcome|Placebo 9 to 12 Years Old|Placebo to match GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845816|NCT01245764|O3|Outcome|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845817|NCT01245764|O2|Outcome|Placebo 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845818|NCT01245764|O1|Outcome|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845819|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845820|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845821|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845822|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845823|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845824|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A
845825|NCT01245764|O2|Outcome|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
845826|NCT01245764|O1|Outcome|GARDASIL 9 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A.
845827|NCT01245764|E4|Reported Event|Placebo 9 to 12 Years Old|Placebo to GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. After database lock and unblinding for study Phase A, participants had the option to receive GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase B.
845828|NCT01245764|E3|Reported Event|GARDASIL 16 to 26 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
845829|NCT01245764|E2|Reported Event|GARDASIL 13 to 15 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
845830|NCT01245764|E1|Reported Event|GARDASIL 9 to 12 Years Old|GARDASIL™ 0.5 mL injection at the Day 1, Month 2, and Month 6 visits in study Phase A. Participants did not continue to study Phase B.
845831|NCT01245751|B5|Baseline|Total|Total of all reporting groups
845832|NCT01245751|B4|Baseline|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845833|NCT01245751|B3|Baseline|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845834|NCT01245751|B2|Baseline|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845835|NCT01245751|B1|Baseline|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845836|NCT01245751|P4|Participant Flow|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845837|NCT01245751|P3|Participant Flow|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845838|NCT01245751|P2|Participant Flow|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845839|NCT01245751|P1|Participant Flow|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845840|NCT01245751|O4|Outcome|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845841|NCT01245751|O3|Outcome|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845842|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845843|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845844|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004(NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845845|NCT01245751|O2|Outcome|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845846|NCT01245751|O1|Outcome|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845847|NCT01245751|E4|Reported Event|Group 4: First Dose Participants ≥50 and <60 Years of Age|Herpes zoster history-negative participants ≥50 and <60 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845848|NCT01245751|E3|Reported Event|Group 3: First Dose Participants ≥60 and <70 Years of Age|Herpes zoster history-negative participants ≥60 and <70 years of age who have never received Zoster Vaccine, Live. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845849|NCT01245751|E2|Reported Event|Group 2: First Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who have never received Zoster Vaccine, Live and are matched to Group 1 participants by age. Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845850|NCT01245751|E1|Reported Event|Group 1: Booster Dose Participants ≥70 Years of Age|Herpes zoster history-negative participants ≥70 years of age who received Zoster Vaccine, Live approximately 10 years prior in the Shingles Prevention Study V211-004 (NCT00007501). Participants received a single Zoster Vaccine, Live vaccination on Day 1.
845851|NCT01245738|B1|Baseline|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845852|NCT01245738|P1|Participant Flow|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845853|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845854|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845855|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845856|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845857|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845858|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845859|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845860|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845861|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845862|NCT01245738|O1|Outcome|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845867|NCT01245738|E1|Reported Event|Participants|Participants admitted to participating tertiary cardiac care centers who experienced a first coronary event.
845868|NCT01245647|B3|Baseline|Total|Total of all reporting groups
845869|NCT01245647|B2|Baseline|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845870|NCT01245647|B1|Baseline|Sugar Pill, 50mg, Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845871|NCT01245647|P2|Participant Flow|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845872|NCT01245647|P1|Participant Flow|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845873|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845874|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845875|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845876|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845877|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845878|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845879|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845880|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845881|NCT01245647|O2|Outcome|Naltrexone, 50mg, Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845882|NCT01245647|O1|Outcome|Sugar Pill, 50mg, Once a Day for 4 Months.|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845883|NCT01245647|E2|Reported Event|Naltrexone, 50mg Pill Once a Day for 4 Months|Naltrexone 50mg pills (single oral capsule): Each study participant in this arm took a single pill once a day for 4 months.
845884|NCT01245647|E1|Reported Event|Sugar Pill, 50 mg Once a Day for 4 Months|Placebo: placebo pills looked the same as the active comparator but were really sugar pills. Each study participant in this arm took a single pill once a day for 4 months.
845885|NCT01245595|B3|Baseline|Total|Total of all reporting groups
845886|NCT01245595|B2|Baseline|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
845887|NCT01245595|B1|Baseline|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
845888|NCT01245595|P2|Participant Flow|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
845889|NCT01245595|P1|Participant Flow|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
845890|NCT01245595|O2|Outcome|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
845891|NCT01245595|O1|Outcome|Aminophylline|"Patients to receive aminophylline 5 mg/kg intravenous (IV) bolus then 1.8 mg/kg IV every six (Q6) hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
845892|NCT01245595|E2|Reported Event|Placebo|"Normal Saline Placebo~Placebo: Normal Saline"
845893|NCT01245595|E1|Reported Event|Aminophylline|"Patients to receive aminophylline 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours~Aminophylline: 5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours"
845894|NCT01245439|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845895|NCT01245439|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845896|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845897|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845942|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
846019|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
845898|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845899|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845900|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845901|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845902|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845903|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845904|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845905|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845906|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845907|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845908|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845909|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845910|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845911|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845912|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845913|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845914|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current (DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845915|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845943|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845916|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845917|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845918|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845919|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845920|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845921|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current Disease-modifying antirheumatic drugs (DMARDs) and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845922|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845923|NCT01245439|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845924|NCT01245439|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (not more than 800 mg) intravenous infusion every 4 weeks for 24 weeks (total of 6 infusions). Participants received tocilizumab monotherapy if they were not tolerating current DMARDs and those who tolerated DMARDs were on the same regimen of tocilizumab in combination with their non-biologic DMARDs.
845925|NCT01245413|B1|Baseline|Entire Study Population|Entire study population = all participlants enrolled in the study
845926|NCT01245413|P2|Participant Flow|Athena Adhesive|Athena =the new test product. The Athena in this trails is an adhesive. The intend use is collecting output from a stoma (e.g an ileostomy and colostomy).
845927|NCT01245413|P1|Participant Flow|SenSura Adhesive|Sensura is an already commercially available baseplate. Designed to collect output from a stoma(e.g an ileostomy and colostomy).
845928|NCT01245413|O2|Outcome|Athena Adhesive|New test adhesive
845929|NCT01245413|O1|Outcome|SenSura Adhesive|Reference adhesive which is commercially available.
845930|NCT01245413|E2|Reported Event|Athena Adhesive|Base-plate adhesion to skin
845931|NCT01245413|E1|Reported Event|SenSura Adhesive|base-plate adhesion to skin
845932|NCT01245387|B1|Baseline|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845933|NCT01245387|P1|Participant Flow|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845934|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845935|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845936|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845937|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845938|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845939|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845940|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845941|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845944|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845945|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845946|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845947|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845948|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845949|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845950|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845951|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845952|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845953|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845954|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845955|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845956|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845957|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845958|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845959|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845960|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845961|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845962|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845963|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845964|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845965|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845966|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845967|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845968|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845969|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
846869|NCT01242527|E2|Reported Event|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
845970|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845971|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845972|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845973|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845974|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845975|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845976|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845977|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845978|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845979|NCT01245387|O1|Outcome|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845980|NCT01245387|E1|Reported Event|Macugen|Intraocular injections of Macugen (pegaptanib) into the study eye. The usage and dosage recommendations were in accordance with the Summary of Product Characteristics (SmPC) and based exclusively on the medical and therapeutic needs.
845981|NCT01245374|B1|Baseline|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845982|NCT01245374|P1|Participant Flow|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845983|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845984|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845985|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845986|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845987|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845988|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845989|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845990|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845991|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845992|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845993|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845994|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845995|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845996|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC).
845997|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845998|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
845999|NCT01245374|O1|Outcome|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
846000|NCT01245374|E1|Reported Event|Norditropin NordiFlex®|Individually adjusted dose administered with Norditropin NordiFlex® for 6 weeks. Dosage depended on age, weight, etiologies and according to the summary of product characteristics (SPC)
846001|NCT01245283|B4|Baseline|Total|Total of all reporting groups
846002|NCT01245283|B3|Baseline|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846003|NCT01245283|B2|Baseline|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846004|NCT01245283|B1|Baseline|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
846005|NCT01245283|P3|Participant Flow|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846006|NCT01245283|P2|Participant Flow|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846007|NCT01245283|P1|Participant Flow|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
846008|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846009|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846010|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
846011|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846012|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846013|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
846014|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846015|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846016|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
846017|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846018|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846870|NCT01242527|E1|Reported Event|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
846020|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846021|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846022|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
846023|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846024|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846025|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
846026|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846027|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846028|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
846029|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846030|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
846031|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.
846032|NCT01245283|O3|Outcome|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846033|NCT01245283|O2|Outcome|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846034|NCT01245283|O1|Outcome|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
846035|NCT01245283|E3|Reported Event|Eccentric Focused RX (ERX)|"The Human Dynamics Laboratory features prototype equipment that increases resistance loads during the eccentric phase of the contraction while “assistance” is provided by the machine during the concentric phase. One set of each exercise - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Eccentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846036|NCT01245283|E2|Reported Event|Concentric Focused RX (CRX)|"Training protocol for 1 set of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.~Concentric Focused Resistance Exercise: Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press."
846037|NCT01245283|E1|Reported Event|Wait-list Non-exercise Control (CON)|"Subjects will continue to participate in their normal activities and clinical care during the four month study period if assigned to this group.~normal activities and clinical care: Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines"
846038|NCT01245270|B3|Baseline|Total|Total of all reporting groups
846082|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846083|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846084|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846092|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846039|NCT01245270|B2|Baseline|Control Capsule First, Then Bilberry Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846040|NCT01245270|B1|Baseline|Bilberry Capsule First, Then Control Capsule|In a cross-over design, eight volunteers were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846041|NCT01245270|P2|Participant Flow|Single Bilberry Capsule First Then Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846042|NCT01245270|P1|Participant Flow|Single Control Capsule First Then Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846043|NCT01245270|O2|Outcome|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846044|NCT01245270|O1|Outcome|Single Control Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846045|NCT01245270|O2|Outcome|Single Blaeberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846085|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846086|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846087|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846088|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846089|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846090|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846046|NCT01245270|O1|Outcome|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846047|NCT01245270|E2|Reported Event|Single Placebo Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846048|NCT01245270|E1|Reported Event|Single Bilberry Capsule|In a cross-over design, volunteers (n 8) were randomised and double-blinded into two groups matched for BMI as well as age and given a single capsule of either 0·47 g of Mirtoselect® (a standardised bilberry extract (36 % (w/w) anthocyanins)) which equates to about 50 g of fresh bilberries formulated in gelatin capsules or a control capsule consisting of microcrystalline cellulose in an opaque gelatin capsule, followed by oral glucose tolerance testing (OGTT). The reverse procedure was conducted following a 2-week washout period. The volunteers were asked to consume a low-phytochemical diet 3 d before taking the capsule and for the 24 h after taking the capsule on both occasions. In addition the volunteers were asked to record what they ate over the same period in a food diary to ensure that they adhered to the low-phytochemical diet. Subjects were reimbursed travelling expenses on completion of the study.
846049|NCT01245140|B3|Baseline|Total|Total of all reporting groups
846050|NCT01245140|B2|Baseline|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846051|NCT01245140|B1|Baseline|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846052|NCT01245140|P2|Participant Flow|Alitretinoin 30 mg|Participants received an alitretinoin 30 milligram (mg) capsule orally QD for up to 24 weeks.
846053|NCT01245140|P1|Participant Flow|Matching Placebo|Participants received matching placebo orally once daily (QD) for up to 24 weeks.
846054|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846055|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846056|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846057|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846058|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846059|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846060|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846061|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846062|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846063|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846064|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846065|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846066|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846067|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846068|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846069|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846070|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846071|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846072|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846073|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846074|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846075|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846076|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846077|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846078|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846079|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846080|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846081|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846871|NCT01242514|B4|Baseline|Total|Total of all reporting groups
846093|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846094|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846095|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846096|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846097|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846098|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846099|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846100|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846101|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846102|NCT01245140|O2|Outcome|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846103|NCT01245140|O1|Outcome|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846104|NCT01245140|E2|Reported Event|Alitretinoin 30 mg|Participants received an alitretinoin 30 mg capsule orally QD for up to 24 weeks.
846105|NCT01245140|E1|Reported Event|Matching Placebo|Participants received matching placebo orally QD for up to 24 weeks.
846106|NCT01245101|B3|Baseline|Total|Total of all reporting groups
846107|NCT01245101|B2|Baseline|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
846108|NCT01245101|B1|Baseline|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
846109|NCT01245101|P2|Participant Flow|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
846110|NCT01245101|P1|Participant Flow|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
846111|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
846112|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
846113|NCT01245101|O2|Outcome|Observation Then Raltegravir|Observation for 16 weeks followed by a washout of 8 weeks followed by Raltegravir 400mg twice a day for 16 weeks.
846114|NCT01245101|O1|Outcome|Raltegravir Then Observation|Raltegravir 400 mg twice a day for 16 weeks followed by a washout of 8 weeks followed by Observation of 16 weeks.
846115|NCT01245101|E2|Reported Event|Observation|Observation for 16 weeks
846116|NCT01245101|E1|Reported Event|Raltegravir|Raltegravir 400 mg twice a day for 16 weeks
846117|NCT01245062|B3|Baseline|Total|Total of all reporting groups
846118|NCT01245062|B2|Baseline|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846119|NCT01245062|B1|Baseline|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846120|NCT01245062|P3|Participant Flow|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
846121|NCT01245062|P2|Participant Flow|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846122|NCT01245062|P1|Participant Flow|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846123|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
846124|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
846125|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846168|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846170|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846126|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846127|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846128|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846129|NCT01245062|O1|Outcome|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
846130|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846131|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846132|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846133|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846134|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846135|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846136|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846137|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846138|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846139|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846140|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846141|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846142|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846872|NCT01242514|B3|Baseline|Fostamatinib 100 mg qd|Oral treatment
846143|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846144|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846145|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846146|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846147|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846148|NCT01245062|O2|Outcome|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an IV dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846149|NCT01245062|O1|Outcome|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846150|NCT01245062|E3|Reported Event|Cross-over From Chemotherapy to Trametinib|Following independent review confirmation of disease progression, participants randomized to chemotherapy were allowed to cross-over to Trametinib.
846151|NCT01245062|E2|Reported Event|Chemotherapy|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received an intravenous (IV) dose of Dacarbazine 1000 mg per square meter every 3 weeks or Paclitaxel 175 mg per square meter every 3 weeks at the discretion of the investigator, provided the participant had not received that type of chemotherapy before randomization, until disease progression, death, or withdrawal.
846152|NCT01245062|E1|Reported Event|Trametinib|Participants with histologically confirmed cutaneous advanced or metastatic melanoma (Stage IIIC or Stage IV), with a BRAF (a human gene encoding for protein called B-Raf, which is involved in a signalling pathway and is important for cell growth) V600 E/K mutation-positive tumor sample as determined via the central BRAF mutation assay, received a Trametinib 2 mg tablet once daily until disease progression, death, or withdrawal.
846153|NCT01244984|B4|Baseline|Total|Total of all reporting groups
846154|NCT01244984|B3|Baseline|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846155|NCT01244984|B2|Baseline|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846156|NCT01244984|B1|Baseline|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846157|NCT01244984|P3|Participant Flow|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846158|NCT01244984|P2|Participant Flow|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846159|NCT01244984|P1|Participant Flow|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg ) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846160|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846161|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846162|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846163|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846164|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846165|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846166|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846167|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846169|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846171|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846172|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846173|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846174|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846175|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846176|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846177|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846178|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846179|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846180|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846181|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846182|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846183|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846184|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846185|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846186|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846187|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846188|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846189|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846190|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846191|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846192|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846193|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846194|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846195|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846196|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846197|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846198|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846199|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846200|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846201|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846202|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846203|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846204|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846873|NCT01242514|B2|Baseline|Fostamatinib 150 mg qd|Oral treatment
846205|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846206|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846207|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846208|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846209|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846210|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846211|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846212|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846213|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846214|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846215|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846216|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846217|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846218|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846219|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846220|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846221|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846222|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846223|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846224|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846225|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846226|NCT01244984|O3|Outcome|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846227|NCT01244984|O2|Outcome|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846228|NCT01244984|O1|Outcome|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846229|NCT01244984|E3|Reported Event|FF 100 µg|Participants received FF inhalation powder 100 µg OD in the evening from the the DPI over the 52 week treatment period.
846230|NCT01244984|E2|Reported Event|FF/GW642444 200/25 µg|Participants received FF/GW642444 inhalation powder 200/25 µg OD in the evening from the DPI over the 52 week treatment period.
846231|NCT01244984|E1|Reported Event|FF/GW642444 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 inhalation powder 100/25 micrograms (µg) once daily (OD) in the evening from the Dry Powder Inhalator (DPI) over the 52 week treatment period.
846232|NCT01244906|B1|Baseline|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846233|NCT01244906|P1|Participant Flow|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846251|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days. Binocular measurements reported only.
846252|NCT01244893|E2|Reported Event|AAP PostQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
846253|NCT01244893|E1|Reported Event|AAP PreQ|Acuvue Advance Plus silicone hydrogel contact lenses will be used both pre- / post-qualification.
846234|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846235|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846236|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846237|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846238|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846239|NCT01244906|O1|Outcome|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846240|NCT01244906|E1|Reported Event|Reduced Intensity Allogeneic Stem Cell Transplantation|"All patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.~Allogeneic Hematopoietic Stem Cell Transplantation: Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis."
846241|NCT01244893|B1|Baseline|All Subjects|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first and Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.
846242|NCT01244893|P2|Participant Flow|Acuvue Advance Plus postQ/Acuvue Advance Plus preQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification will be worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification will be worn second."
846243|NCT01244893|P1|Participant Flow|Acuvue Advance Plus preQ/Acuvue Advance Plus postQ|"Arm 1:~Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn first, then Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn second.~Arm 2:~Acuvue AdvancePlus silicone hydrogel contact lens manufactured after qualification were worn first, then Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn second."
846244|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-9 days.
846245|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-9 days.
846246|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days.
846247|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
846248|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post to qualification were worn daily for 6-8 days.
846249|NCT01244893|O1|Outcome|Acuvue Advance Plus preQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured prior to qualification were worn daily for 6-8 days.
846250|NCT01244893|O2|Outcome|Acuvue Advance Plus postQ|Acuvue Advance Plus silicone hydrogel contact lens manufactured post qualification were worn daily for 6-8 days. Binocular measurements reported only.
846874|NCT01242514|B1|Baseline|Fostamatinib 100 mg Bid|Oral treatment
846254|NCT01244828|B1|Baseline|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846255|NCT01244828|P1|Participant Flow|Asenapine|All participants receive asenapine 5 mg twice daily (BID) for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846256|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846257|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846258|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846259|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846260|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846261|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846262|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846263|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846264|NCT01244828|O1|Outcome|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846265|NCT01244828|E1|Reported Event|Asenapine|All participants receive asenapine 5 mg BID for the first 7 days of treatment. After the initial 7-day period, the asenapine dose may be increased to 10 mg BID based on observed response to and toleration of the treatment. Asenapine dosing is flexible throughout the remainder of the study and may be adjusted, using the dose options of 5 and 10 mg BID, based on response and tolerability. The total duration of treatment is up to 52 weeks.
846266|NCT01244815|B5|Baseline|Total|Total of all reporting groups
846267|NCT01244815|B4|Baseline|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846268|NCT01244815|B3|Baseline|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846269|NCT01244815|B2|Baseline|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846270|NCT01244815|B1|Baseline|Placebo|Participants receive placebo BID for 21 days.
846271|NCT01244815|P4|Participant Flow|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846333|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846491|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846272|NCT01244815|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846273|NCT01244815|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846274|NCT01244815|P1|Participant Flow|Placebo|Participants receive placebo twice daily (BID) for 21 days.
846275|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846276|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846277|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846278|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846279|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846280|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846281|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846282|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846283|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846284|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846285|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846286|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846287|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846288|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846289|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846290|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846291|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846292|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846293|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846294|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846295|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846296|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846297|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846298|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846299|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846300|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846301|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846302|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846334|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846492|NCT01244490|O1|Outcome|Placebo|Once daily
846303|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846304|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846305|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846306|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846307|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846308|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846309|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846310|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846311|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846312|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846313|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846314|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846315|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846316|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846317|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846318|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846319|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846320|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846321|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846322|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846323|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846324|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846325|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846326|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846327|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846328|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846329|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846330|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846331|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846332|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846335|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846336|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846337|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846338|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846339|NCT01244815|O4|Outcome|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846340|NCT01244815|O3|Outcome|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846341|NCT01244815|O2|Outcome|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846342|NCT01244815|O1|Outcome|Placebo|Participants receive placebo BID for 21 days.
846343|NCT01244815|E4|Reported Event|Asenapine 10.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. On Day 5 and 6 participants receive asenapine 5.0 mg BID. On Day 7 participants receive asenapine 5.0 mg in the morning and 10.0 mg in the evening. Participants receive asenapine 10.0 mg BID for the remainder of the 21-day treatment period.
846344|NCT01244815|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive asenapine 2.5 mg BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive asenapine 5.0 mg BID for the remainder of the 21-day treatment period.
846345|NCT01244815|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive asenapine 2.5 mg BID for 21 days.
846346|NCT01244815|E1|Reported Event|Placebo|Participants receive placebo BID for 21 days.
846347|NCT01244724|B1|Baseline|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
846348|NCT01244724|P1|Participant Flow|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
846349|NCT01244724|O1|Outcome|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
846350|NCT01244724|E1|Reported Event|Lexapro|Lexapro: Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
846351|NCT01244711|B1|Baseline|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
846352|NCT01244711|P1|Participant Flow|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
846353|NCT01244711|O1|Outcome|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
846354|NCT01244711|E1|Reported Event|Quetiapine|"Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.~quetiapine: Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects."
846355|NCT01244633|B1|Baseline|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
846356|NCT01244633|P1|Participant Flow|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
846357|NCT01244633|O1|Outcome|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
846358|NCT01244633|E1|Reported Event|Ecopipam|"Active treatment~Ecopipam: 50 or 100 mg tablets given once per day for eight weeks"
846359|NCT01244620|B1|Baseline|Entire Study Population|All randomized participants
846360|NCT01244620|P4|Participant Flow|Sitax and Sild, Then Sitax and Tad, Then Tad, Then Sitax|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
846389|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846361|NCT01244620|P3|Participant Flow|Sitax and Tad, Then Sitax, Then Sitax and Sild, Then Tad|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
846362|NCT01244620|P2|Participant Flow|Tad, Then Sitax and Sild, Then Sitax, Then Sitax and Tad|Tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days, then sitaxsentan 100 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days. Only the first treatment in the sequence was administered due to the early termination.
846363|NCT01244620|P1|Participant Flow|Sitax, Then Tad, Then Sitax and Tad, Then Sitax and Sild|Sitaxsentan 100 milligram (mg) tablet once daily (QD) for 6 days, then tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days, then sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table three times daily (TID) for 6 days. Only the first treatment in the sequence was administered due to the early termination.
846364|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846365|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846366|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846367|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846368|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846369|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846370|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846371|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846372|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846373|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846374|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846375|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846376|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846377|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846378|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846379|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846380|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846381|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846382|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846383|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846384|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846385|NCT01244620|O3|Outcome|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846386|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846387|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846388|NCT01244620|O4|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg tablet TID for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846390|NCT01244620|O2|Outcome|Tadalafil|Tadalafil 40 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846391|NCT01244620|O1|Outcome|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days during any treatment period. Only the first treatment in the sequence was administered due to the early termination.
846392|NCT01244620|E4|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg tablet QD co-administered with sildenafil 20 mg table TID for 6 days
846393|NCT01244620|E3|Reported Event|Sitaxsentan and Tadalafil|Sitaxsentan 100 mg tablet QD co-administered with tadalafil 40 mg tablet QD for 6 days
846394|NCT01244620|E2|Reported Event|Tadalafil|Tadalafil 40 mg tablet QD for 6 days
846395|NCT01244620|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 mg tablet QD for 6 days
846396|NCT01244529|B1|Baseline|All Subjects|All subjects who where enrolled wore all intervention lenses throughout the course of the study. The specific lenses used include the following: senofilcon A (control) soft contact lens with 8.8 base; senofilcon A (control) soft contact lens with 8.4 base curve; galyfilcon A (control) soft contact lens with 8.7 base curve; galyfilcon A (control) soft contact lens with 8.3 base curve; galyfilcon A Plus (test) soft contact lens with 8.7 base curve; galyfilcon A Plus (test) soft contact lens with 8.3 base curve.
846397|NCT01244529|P1|Participant Flow|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
846398|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC vs Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846399|NCT01244529|O3|Outcome|Galyfilcon AP 8.7 BC vs Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846400|NCT01244529|O2|Outcome|Galyfilcon AP 8.3 BC vs Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846401|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC vs Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846402|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846403|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846404|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846405|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846406|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846407|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846408|NCT01244529|O6|Outcome|Senofilcon A 8.8 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846409|NCT01244529|O5|Outcome|Galyfilcon A 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846410|NCT01244529|O4|Outcome|Galyfilcon AP 8.7 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846411|NCT01244529|O3|Outcome|Senofilcon A 8.4 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846412|NCT01244529|O2|Outcome|Galyfilcon A 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846413|NCT01244529|O1|Outcome|Galyfilcon AP 8.3 BC|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846414|NCT01244529|O3|Outcome|Senofilcon A|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846415|NCT01244529|O2|Outcome|Galyfilcon A (Control)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846416|NCT01244529|O1|Outcome|Galyfilcon A Plus (Test)|All subjects wore each of the lenses at a point in the study as this was a contralateral study.
846417|NCT01244529|E1|Reported Event|All Arms, All Interventions|All subjects wore all intervention throughout the course of the study.
846418|NCT01244516|B4|Baseline|Total|Total of all reporting groups
846419|NCT01244516|B3|Baseline|BIO (Biofinity)|Subjects that were randomized to wear Biofinity lens throughout the course of the study.
846420|NCT01244516|B2|Baseline|AOA (Air Optic)|Subjects that were randomized to wear AOA lens throughout the course of the study.
846421|NCT01244516|B1|Baseline|AAHP (Acuvue)|Subjects that were randomized to wear AAHP lens throughout the course of the study.
846422|NCT01244516|P3|Participant Flow|Comfilcon A|comfilcon A, base curve 8.60
846423|NCT01244516|P2|Participant Flow|Lotrafilcon B|lotrafilcon B, base curve 8.60
846424|NCT01244516|P1|Participant Flow|Galyfilcon A|galyfilcon A base curve 8.30
846425|NCT01244516|O2|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
846426|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
846427|NCT01244516|O3|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
846428|NCT01244516|O2|Outcome|Lotrafilcon B (AOA)|lotrafilcon B, base curve 8.60
846429|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
846430|NCT01244516|O3|Outcome|Comfilcon A (BIO)|comfilcon A, base curve 8.60
846431|NCT01244516|O2|Outcome|Lotrafilcon B (AOA)|lotrafilcon B, base curve 8.60
846432|NCT01244516|O1|Outcome|Galyfilcon A (AAPA)|galyfilcon A base curve 8.30
846433|NCT01244516|E3|Reported Event|Comfilcon A|comfilcon A, base curve 8.60
846434|NCT01244516|E2|Reported Event|Lotrafilcon B|lotrafilcon B, base curve 8.60
846435|NCT01244516|E1|Reported Event|Galyfilcon A|galyfilcon A base curve 8.30
846436|NCT01244503|B1|Baseline|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
846490|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846437|NCT01244503|P1|Participant Flow|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
846438|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
846439|NCT01244503|O1|Outcome|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
846440|NCT01244503|E1|Reported Event|Sodium Octanoate Breath Test|"Only subjects with metabolic syndrome and suspected non alcoholic fatty liver disease will undergo breath test. They must not have any other liver disease.~Sodium Octanoate Breath Test: 100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed."
846441|NCT01244490|B4|Baseline|Total|Total of all reporting groups
846442|NCT01244490|B3|Baseline|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846443|NCT01244490|B2|Baseline|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846444|NCT01244490|B1|Baseline|Placebo|Once daily
846445|NCT01244490|P3|Participant Flow|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846446|NCT01244490|P2|Participant Flow|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846447|NCT01244490|P1|Participant Flow|Placebo|Once daily
846448|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846449|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846450|NCT01244490|O1|Outcome|Placebo|Once daily
846451|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846452|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846453|NCT01244490|O1|Outcome|Placebo|Once daily
846454|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846455|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846456|NCT01244490|O1|Outcome|Placebo|Once daily
846457|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846458|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846459|NCT01244490|O1|Outcome|Placebo|Once daily
846460|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846461|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846462|NCT01244490|O1|Outcome|Placebo|Once daily
846463|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846464|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846465|NCT01244490|O1|Outcome|Placebo|Once daily
846466|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846467|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846468|NCT01244490|O1|Outcome|Placebo|Once daily
846469|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846470|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846471|NCT01244490|O1|Outcome|Placebo|Once daily
846472|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846473|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846474|NCT01244490|O1|Outcome|Placebo|Once daily
846475|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846476|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846477|NCT01244490|O1|Outcome|Placebo|Once daily
846478|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846479|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846480|NCT01244490|O1|Outcome|Placebo|Once daily
846481|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846482|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846483|NCT01244490|O1|Outcome|Placebo|Once daily
846484|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846485|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846486|NCT01244490|O1|Outcome|Placebo|Once daily
846487|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846488|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846489|NCT01244490|O1|Outcome|Placebo|Once daily
846493|NCT01244490|O3|Outcome|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846494|NCT01244490|O2|Outcome|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846495|NCT01244490|O1|Outcome|Placebo|Once daily
846496|NCT01244490|E3|Reported Event|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight)
846497|NCT01244490|E2|Reported Event|Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight)
846498|NCT01244490|E1|Reported Event|Placebo|Once daily
846499|NCT01244477|B3|Baseline|Total|Total of all reporting groups
846500|NCT01244477|B2|Baseline|Arm 2|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
846501|NCT01244477|B1|Baseline|Arm 1|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
846502|NCT01244477|P2|Participant Flow|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
846503|NCT01244477|P1|Participant Flow|CPT-C|Group Cognitive Processing Therapy-C (CPT-C): Participants who chose to participate in a 12-week CPT-C treatment group.
846504|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
846505|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
846506|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
846507|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
846508|NCT01244477|O2|Outcome|Treatment-as-Usual|Participants who chose to participate in a 12-week treatment as usual group and offered CPT-C group treatment after 12 weeks.
846509|NCT01244477|O1|Outcome|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants who chose to participate in a 12-week CPT-C treatment group."
846510|NCT01244477|E2|Reported Event|Treatment-as-Usual|Participants randomly assigned to the Waitlist Control Group (who will participate in CPT-C after 12 weeks).
846511|NCT01244477|E1|Reported Event|CPT-C|"Participants in group CPT-C~Group CPT-C: Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks."
846512|NCT01244425|B3|Baseline|Total|Total of all reporting groups
846513|NCT01244425|B2|Baseline|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
846514|NCT01244425|B1|Baseline|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
846515|NCT01244425|P2|Participant Flow|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the oozing resection surface of the liver. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
846516|NCT01244425|P1|Participant Flow|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4, 6, 8 and 10 minutes after application of the study treatment.
846517|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
846518|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
846519|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
846520|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
846521|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
846522|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
846523|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
846524|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
846525|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 10 minutes after application of the study treatment.
846526|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 10 minutes after application of the study treatment.
846527|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 8 minutes after application of the study treatment.
846528|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 8 minutes after application of the study treatment.
846529|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 6 minutes after application of the study treatment.
846530|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 6 minutes after application of the study treatment.
846531|NCT01244425|O2|Outcome|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver. Hemostasis will be assessed at 4 minutes after application of the study treatment.
846532|NCT01244425|O1|Outcome|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant. Hemostasis will be assessed at 4 minutes after application of the study treatment.
846533|NCT01244425|E2|Reported Event|Manual Compression - Control|A dry surgical gauze swab will be used to apply by hand an even light pressure onto the resection surface of the liver.
846534|NCT01244425|E1|Reported Event|FS VH S/D 500 S-apr|Fibrin Sealant, Vapor Heated, Solvent/Detergent treated with 500 IU/mL thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), not to exceed 20mL per participant.
846535|NCT01244412|B1|Baseline|Imaged Subjects|
846536|NCT01244412|P1|Participant Flow|Imaged Subjects|Subjects imaged with hand held device
846537|NCT01244412|O1|Outcome|Imaged Subjects|
846538|NCT01244412|E1|Reported Event|Imaged Subjects|
846539|NCT01244243|B1|Baseline|Active Therapy|"All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.~Hand & Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks."
846540|NCT01244243|P1|Participant Flow|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
846541|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
846542|NCT01244243|O1|Outcome|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
846543|NCT01244243|E1|Reported Event|Active Therapy|All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
846544|NCT01244126|B4|Baseline|Total|Total of all reporting groups
846545|NCT01244126|B3|Baseline|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
846546|NCT01244126|B2|Baseline|IV Morphine|0.1 mg/kg morphine IV
846547|NCT01244126|B1|Baseline|IM Morphine|0.1 mg/kg morphine IM
846548|NCT01244126|P3|Participant Flow|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
846549|NCT01244126|P2|Participant Flow|IV Morphine|0.1 mg/kg morphine IV
846550|NCT01244126|P1|Participant Flow|IM Morphine|0.1 mg/kg morphine IM
846551|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
846552|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
846553|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
846554|NCT01244126|O3|Outcome|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
846555|NCT01244126|O2|Outcome|IV Morphine|0.1 mg/kg morphine IV
846556|NCT01244126|O1|Outcome|IM Morphine|0.1 mg/kg morphine IM
846557|NCT01244126|E3|Reported Event|IV Morphine|0.1 mg/kg morphine IV
846558|NCT01244126|E2|Reported Event|Fentanyl IN|Intranasal fentanyl 2 mcg/kg IN
846559|NCT01244126|E1|Reported Event|IM Morphine|0.1 mg/kg morphine IM
846560|NCT01244061|B3|Baseline|Total|Total of all reporting groups
846561|NCT01244061|B2|Baseline|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
846562|NCT01244061|B1|Baseline|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
846563|NCT01244061|P2|Participant Flow|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
846564|NCT01244061|P1|Participant Flow|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
846565|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
846566|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
846567|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
846568|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
846569|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
846570|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
846651|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846571|NCT01244061|O2|Outcome|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
846572|NCT01244061|O1|Outcome|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
846573|NCT01244061|E2|Reported Event|Placebo|Participants received 1 tablet per day of placebo from Days 1 to 3, which was titrated up to 2 tablets per day from Days 4 to 7, and then to 4 tablets per day (2 tablets in the morning and 2 tablets in the evening) from Week 1 to Week 12.
846574|NCT01244061|E1|Reported Event|Varenicline|Participants received 0.5 mg per day of varenicline on Days 1 to 3, 1.0 mg per day on Days 4 to 7, and 2.0 mg per day (1.0 mg twice daily, ie, 2 x 0.5 mg tablets in the morning and 2 x 0.5 mg tablets in the evening) from Weeks 1 to 12.
846575|NCT01243944|B3|Baseline|Total|Total of all reporting groups
846576|NCT01243944|B2|Baseline|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846577|NCT01243944|B1|Baseline|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846578|NCT01243944|P2|Participant Flow|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846579|NCT01243944|P1|Participant Flow|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg once a day (QD) to 25 mg BID based on safety and efficacy
846580|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846581|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846582|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846583|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846584|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846585|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846586|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846587|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846588|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846589|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846590|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846591|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846592|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846593|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846594|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846595|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846596|NCT01243944|O2|Outcome|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846597|NCT01243944|O1|Outcome|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846598|NCT01243944|E2|Reported Event|Best Available Therapy|Best Available Therapy (BAT) will be selected by the Investigator for each subject. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
846599|NCT01243944|E1|Reported Event|Ruxolitinib|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
846601|NCT01243892|B2|Baseline|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846602|NCT01243892|B1|Baseline|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846603|NCT01243892|P2|Participant Flow|ISS Participants|Idiopathic short stature (ISS) participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846604|NCT01243892|P1|Participant Flow|IGHD Participants|Isolated growth hormone deficient (IGHD) participants who initiated somatropin (Deoxyribonucleic acid [DNA] origin) (recombinant human growth hormone [rhGH]) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846605|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846606|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846607|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846608|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846609|NCT01243892|O2|Outcome|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846610|NCT01243892|O1|Outcome|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846611|NCT01243892|E2|Reported Event|ISS Participants|ISS participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846612|NCT01243892|E1|Reported Event|IGHD Participants|IGHD participants who initiated somatropin (DNA origin) (rhGH) using the NuSpin device, were observed for at least 2 years. The choice of initiation of NuSpin treatment and the treatment regimen was as per treating physician’s discretion, the study protocol did not enforce or specified any treatment regimen.
846613|NCT01243775|B1|Baseline|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
846614|NCT01243775|P1|Participant Flow|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) Belloxa 70 mg/m2 3 weekly (day 2)
846615|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
846616|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
846617|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
846618|NCT01243775|O1|Outcome|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
846619|NCT01243775|E1|Reported Event|Belotaxel Plus Belloxa|Belotaxel 60 mg/m2 3 weekly (day 1) plus Belloxa 70 mg/m2 3 weekly (day 2)
846620|NCT01243671|B1|Baseline|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846621|NCT01243671|P1|Participant Flow|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846622|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846623|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846624|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846625|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846626|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846627|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846628|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846629|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846630|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846631|NCT01243671|O1|Outcome|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846632|NCT01243671|E1|Reported Event|Adalimumab|Adalimumab 160 mg at Week 0, 80 mg at Week 2 and 40 mg every other week (eow) starting at Week 4 to Week 50, subcutaneous injection. After Week 52, participants could continue the treatment with 40 mg eow until the day before approval of adalimumab for intestinal Behçet's disease in Japan.
846633|NCT01243619|B1|Baseline|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
846634|NCT01243619|P1|Participant Flow|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
846635|NCT01243619|O1|Outcome|All Participants|"All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.~All patients accepted and complied with having three sets of PET scans performed (six total PET scans).~The software used in this protocol has allowed quantitative comparison among the PET scans."
846636|NCT01243619|E1|Reported Event|All Participants|All participants in the trial received an FDG PET scan before and after chemoradiation for esophageal cancer. In addition, as experimental staging studies, patients on this protocol received a third FDG PET scan during chemoradiation, and received three FLT PET scans before, during and after chemoradiation. All patients received standard of care chemotherapy and radiation and went on to esphagectomy.
846637|NCT01243567|B3|Baseline|Total|Total of all reporting groups
846638|NCT01243567|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846639|NCT01243567|B1|Baseline|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846640|NCT01243567|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846641|NCT01243567|P1|Participant Flow|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846642|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846643|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846644|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846645|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846646|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846647|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846648|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846649|NCT01243567|O1|Outcome|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846650|NCT01243567|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846652|NCT01243567|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846653|NCT01243567|E1|Reported Event|Bimatoprost 0.03%/Timolol 0.5% Combination Ophthalmic Solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
846654|NCT01243450|B4|Baseline|Total|Total of all reporting groups
846655|NCT01243450|B3|Baseline|Placebo|Placebo group
846656|NCT01243450|B2|Baseline|Brand|Brand group
846657|NCT01243450|B1|Baseline|Active Generic|Active generic group
846658|NCT01243450|P3|Participant Flow|Brand|Tretinoin: Topical skin
846659|NCT01243450|P2|Participant Flow|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
846660|NCT01243450|P1|Participant Flow|Active Generic|"active cream~Tretinoin: Topical skin"
846661|NCT01243450|O3|Outcome|Brand|Tretinoin: Topical skin
846662|NCT01243450|O2|Outcome|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
846663|NCT01243450|O1|Outcome|Active Generic|"active cream~Tretinoin: Topical skin"
846664|NCT01243450|E3|Reported Event|Brand|Tretinoin: Topical skin
846665|NCT01243450|E2|Reported Event|Placebo|"placebo cream~Tretinoin: Topical skin~placebo"
846666|NCT01243450|E1|Reported Event|Active Generic|"active cream~Tretinoin: Topical skin"
846667|NCT01243411|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846668|NCT01243411|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846669|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846670|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846671|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846672|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846673|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846674|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846675|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846676|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846677|NCT01243411|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846678|NCT01243411|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)"
846679|NCT01243320|B1|Baseline|All Study Participants|10 ppm Silver, then 32 ppm Silver
846680|NCT01243320|P1|Participant Flow|All Study Participants|Study had two dosing phases. All study participants were assigned the 10ppm Oral Silver and proceed to the 32 pm Oral Silver.
846681|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846682|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846683|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846684|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846685|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846686|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846687|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846688|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846689|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846690|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846691|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846692|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846693|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846694|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846695|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846697|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846698|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846699|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846700|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846701|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846702|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846703|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846704|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846705|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846706|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846707|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846708|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846709|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846710|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846711|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846712|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846713|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846714|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846715|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846716|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846717|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846718|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846719|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846720|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846721|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846722|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846723|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846724|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846725|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846726|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846727|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846728|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846729|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846730|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846731|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846732|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846733|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846734|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846735|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846736|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846737|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846738|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846739|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846740|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846741|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846742|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846743|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846744|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846745|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846746|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846747|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846748|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846749|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846750|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846751|NCT01243320|O2|Outcome|32ppm Oral Silver|ASAP Solution 32 ppm Diluent: Silver nanoparticles at 32ppm
846752|NCT01243320|O1|Outcome|10ppm Oral Silver|ASAP Solution 10 ppm: Silver nanoparticles at 10ppm
846753|NCT01243320|E2|Reported Event|32ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
846754|NCT01243320|E1|Reported Event|10ppm Oral Solution|All participants received the 10ppm Silver, then progressed to the 32 ppm Silver.
846755|NCT01243294|B1|Baseline|Entire Study Population|Includes groups randomized to receive SS (new ostomy bag)first and SenSura first
846776|NCT01243242|P1|Participant Flow|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
846777|NCT01243242|O2|Outcome|Placebo|Eligible subjects who received 1400 mg of Placebo
846756|NCT01243294|P2|Participant Flow|SS First, Then SenSura|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846757|NCT01243294|P1|Participant Flow|SenSura First, Then SS|"SS = new ostomy bag. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846758|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846759|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846760|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846761|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846762|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846763|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846764|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846765|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846766|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846767|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846768|NCT01243294|O2|Outcome|SenSura|"CE marked and launched SenSura used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a stoma (e.g. a ileostomy or a colostomy).~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846769|NCT01243294|O1|Outcome|New Adhesive SS|"SS = new adhesive. SS used in this trial is a 1-piece closed ostomy product consisting of a base plate and a bag. The intended use is collecting output from a colostomy.~Both SS and SenSura is changed 1 till 6 times a day, depending on when the bag is full, or if there is leakage.~The difference between the two products is the adhesive on the base plate where SS have a softer adhesive than SenSura. It is this soft adhesive we wanted to test."
846770|NCT01243294|E2|Reported Event|SS (New Ostomy Bag)|Base plates applied 1 till 6 times a day SS = new ostomy bag
846786|NCT01243242|E1|Reported Event|METADOXINE(MG01CI)|Eligible subjects who received 1400 mg of Metadoxine
846787|NCT01243177|B3|Baseline|Total Title|
846788|NCT01243177|B2|Baseline|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846789|NCT01243177|B1|Baseline|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846790|NCT01243177|P2|Participant Flow|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846791|NCT01243177|P1|Participant Flow|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846792|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846793|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846794|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846795|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846796|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846797|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846798|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846799|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846800|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846801|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846802|NCT01243177|O2|Outcome|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846803|NCT01243177|O1|Outcome|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846804|NCT01243177|E2|Reported Event|Carbamazepine-Controlled Release (CBZ-CR)|"Strengths: 200 mg~Form: tablets~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose~Duration: up to 118 weeks"
846805|NCT01243177|E1|Reported Event|Lacosamide|"Strengths: 50 mg / 100 mg~Form: tablets~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose~Duration: up to 118 weeks"
846806|NCT01243112|B1|Baseline|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
846807|NCT01243112|P1|Participant Flow|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
846862|NCT01242527|P1|Participant Flow|Olive Oil (Placebo Control)|placebo : 4 capsules (1g) daily for 12 weeks
846863|NCT01242527|O4|Outcome|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
846808|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
846809|NCT01243112|O1|Outcome|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
846810|NCT01243112|E1|Reported Event|Study Group|0.2 ml 1% Lidocaine with Epinephrine (1:100,000), 0.2 ml 0.25% Bupivacaine with Epinephrine (1:200,000) 0.2 ml 0.5% Lidocaine and 0.125% Bupivacaine with Epinephrine Epinephrine (1:150,000) 2 ml of 1% Lidocaine and 0.25% Bupivacaine with Epinephrine (1:150,000)
846894|NCT01242371|B2|Baseline|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
846811|NCT01242813|B1|Baseline|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846812|NCT01242813|P1|Participant Flow|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 milligram/ kilogram (mg/kg) for participants equal to or less than (≤) 40 kg or 150 mg for participants more than (>) 40 kg) through subcutaneous (s.c.) route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TNF-receptor associated periodic syndrome (TRAPS) flare.
846813|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846814|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846815|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846816|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846817|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846818|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846819|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846820|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846821|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846822|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846823|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846824|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846825|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846826|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846827|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846864|NCT01242527|O3|Outcome|Epanova 3 g|omefas : 3 capsules (1g) + 1 placebo daily for 12 weeks
846828|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846829|NCT01242813|O1|Outcome|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846895|NCT01242371|B1|Baseline|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
846830|NCT01242813|E1|Reported Event|Canakinumab|Participants received body-weight stratified dosage of canakinumab (2 mg/kg for participants ≤ 40 kg or 150 mg for participants > 40 kg) through s.c. route as the starting dose at baseline and monthly for 4 months. The dose was escalated at Day 8 if dose of canakinumab was not sufficient to resolve the qualifying TRAPS flare.
846831|NCT01242748|B3|Baseline|Total|Total of all reporting groups
846832|NCT01242748|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846833|NCT01242748|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846834|NCT01242748|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846835|NCT01242748|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846836|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846837|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846838|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846839|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846840|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846841|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846865|NCT01242527|O2|Outcome|Epanova 2 g|omefas : 2 capsules (1g) + 2 placebo daily for 12 weeks
846866|NCT01242527|O1|Outcome|Olive Oil (Placebo)|placebo : 4 capsules (1g) daily for 12 weeks
846842|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846896|NCT01242371|P2|Participant Flow|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
846843|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846844|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846845|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846846|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846847|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846848|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846849|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846850|NCT01242748|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846851|NCT01242748|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846852|NCT01242748|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
846853|NCT01242748|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
846854|NCT01242527|B5|Baseline|Total|Total of all reporting groups
846855|NCT01242527|B4|Baseline|Epanova 4 g|omefas : 4 capsules (1g)daily for 12 weeks
846875|NCT01242514|P3|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
846876|NCT01242514|P2|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
846877|NCT01242514|P1|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
846878|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
846879|NCT01242514|O2|Outcome|Fostamatinib 150 mg qd|Oral treatment
846880|NCT01242514|O1|Outcome|Fostamatinib 100 mg Bid|Oral treatment
846881|NCT01242514|O3|Outcome|Fostamatinib 100 mg qd|Oral treatment
846897|NCT01242371|P1|Participant Flow|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
846898|NCT01242371|O2|Outcome|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
846899|NCT01242371|O1|Outcome|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
846900|NCT01242371|E2|Reported Event|Identical-appearing Placebo|Identical appearing placebo 1 tablet by mouth daily for 14 weeks
846901|NCT01242371|E1|Reported Event|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily for 14 weeks
846902|NCT01242176|B1|Baseline|Study Overall|"An open-label, randomised, two-way crossover study. The two treatments administered were~A single dose of empagliflozin (empa) 25mg, final formulation~A single dose of empa 25mg, trial formulation 2~Between drug administrations there was a washout period of at least 7 days."
846903|NCT01242176|P2|Participant Flow|Empa TF2 / Empa FF|Single dose of 25mg empagliflozin (empa) trial formulation 2 (TF2) followed by a single dose of 25mg of empa final formulation (FF), with a washout period of at least 7 days between treatments.
846904|NCT01242176|P1|Participant Flow|Empa FF / Empa TF2|Single dose of 25mg of empagliflozin (empa) final formulation (FF) followed by a single dose of 25mg empa trial formulation 2 (TF2), with a washout period of at least 7 days between treatments.
846905|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
846906|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
846907|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
846908|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
846909|NCT01242176|O2|Outcome|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
846910|NCT01242176|O1|Outcome|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
846911|NCT01242176|E2|Reported Event|Empa TF2|Single dose of empagliflozin (empa) 25 mg, trial formulation 2 (TF2), following an overnight fast of at least 10 hours.
846912|NCT01242176|E1|Reported Event|Empa FF|Single dose of empagliflozin (empa) 25 mg, final formulation (FF), following an overnight fast of at least 10 hours.
846913|NCT01242111|B1|Baseline|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846914|NCT01242111|P1|Participant Flow|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846915|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846916|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846917|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846918|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846919|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846920|NCT01242111|O1|Outcome|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846921|NCT01242111|E1|Reported Event|BMN 110|BMN 110: Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
846922|NCT01242085|B4|Baseline|Total|Total of all reporting groups
846923|NCT01242085|B3|Baseline|Both Interventions|one participant had bilateral knee replacement with one control knee and one trumatch knee
846924|NCT01242085|B2|Baseline|Trumatch Group|patients randomized to study instrumentation
846925|NCT01242085|B1|Baseline|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
846926|NCT01242085|P3|Participant Flow|Both Interventions|one participant had both interventions - one for each knee
846927|NCT01242085|P2|Participant Flow|Control Group|control group will have standard instrumentation of their knee replacement
846928|NCT01242085|P1|Participant Flow|Trumatch Group|trumatch group will have customized knee instruments : CT based customized knee instruments
846929|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
846930|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
846931|NCT01242085|O2|Outcome|Trumatch Group|patients randomized to study instrumentation
846932|NCT01242085|O1|Outcome|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
846933|NCT01242085|E2|Reported Event|Trumatch Group|patients randomized to study instrumentation
846934|NCT01242085|E1|Reported Event|Control|"control group will have standard instrumentation of their knee replacement: standard instrumentation for knee replacement~study group will have customized knee instruments : CT based customized knee instruments"
846935|NCT01241916|B3|Baseline|Total|Total of all reporting groups
846936|NCT01241916|B2|Baseline|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
847190|NCT01241552|P2|Participant Flow|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
846937|NCT01241916|B1|Baseline|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
846938|NCT01241916|P2|Participant Flow|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
846939|NCT01241916|P1|Participant Flow|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
846940|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
846941|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
846942|NCT01241916|O2|Outcome|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
846943|NCT01241916|O1|Outcome|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
846944|NCT01241916|E2|Reported Event|Dynamic Splint|Splint is worn for approximately 6 to 8 continuous hours per day or night. This splint applies a consistent force to the tissues that is maintained as the tissues stretch.
846945|NCT01241916|E1|Reported Event|Static-progressive Splint|Splint is worn three times per day for a 30-minute period. This splint uses stepwise increases in angle to apply force to contracted tissues that dissipates as the tissues stretch.
846946|NCT01241903|B3|Baseline|Total|Total of all reporting groups
846947|NCT01241903|B2|Baseline|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
846948|NCT01241903|B1|Baseline|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
846949|NCT01241903|P2|Participant Flow|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
846950|NCT01241903|P1|Participant Flow|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
846951|NCT01241903|O2|Outcome|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
846952|NCT01241903|O1|Outcome|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
846953|NCT01241903|E2|Reported Event|Rosuvastatin|Subjects randomized to the rosuvastatin arm received rosuvastatin 40mg following enrollment (day 1) and rosustatin 20mg for the next 30 days starting at day 2.
846954|NCT01241903|E1|Reported Event|Placebo|Subjects randomized to the placebo arm received a placebo dose at enrollment (day 1) and rosuvastatin 20mg for the next 30 days starting on day 2.
846955|NCT01241760|B3|Baseline|Total|Total of all reporting groups
846956|NCT01241760|B2|Baseline|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846957|NCT01241760|B1|Baseline|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846958|NCT01241760|P2|Participant Flow|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846959|NCT01241760|P1|Participant Flow|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846960|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846961|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846962|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846963|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846988|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846964|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846965|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846966|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846967|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846968|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846969|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846970|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846971|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846972|NCT01241760|O2|Outcome|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846973|NCT01241760|O1|Outcome|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846974|NCT01241760|E3|Reported Event|Total|All
846975|NCT01241760|E2|Reported Event|T12(b.i.d.)/PR|Telaprevir 1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846976|NCT01241760|E1|Reported Event|T12(q8h)/PR|Telaprevir 750 mg (2 oral tablets) every 8 hours for 12 weeks, in combination with pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day for 24 or 48 weeks depending on the treatment response at week 4.
846977|NCT01241591|B5|Baseline|Total|Total of all reporting groups
846978|NCT01241591|B4|Baseline|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846979|NCT01241591|B3|Baseline|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846980|NCT01241591|B2|Baseline|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846981|NCT01241591|B1|Baseline|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846982|NCT01241591|P4|Participant Flow|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846983|NCT01241591|P3|Participant Flow|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846984|NCT01241591|P2|Participant Flow|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846985|NCT01241591|P1|Participant Flow|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846986|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846987|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846989|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846990|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846991|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846992|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846993|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846994|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846995|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846996|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846997|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846998|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
846999|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847000|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847001|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847002|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847003|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847004|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847005|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847006|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847007|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847008|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847009|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847010|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847011|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847012|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847013|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847014|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847015|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847016|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847017|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847018|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847019|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847020|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847021|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847022|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847023|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847024|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847025|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847026|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847027|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847028|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847029|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847030|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847031|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847032|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847033|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847034|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847035|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847036|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847037|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847038|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847039|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847040|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847041|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847042|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847043|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847044|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847045|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847046|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847047|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847048|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847049|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847050|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847051|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847052|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847053|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847054|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847055|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847056|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847057|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847058|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847059|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847060|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847061|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847062|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847063|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847064|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847065|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847066|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847067|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847068|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847069|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847070|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847071|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847072|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847073|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847074|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847075|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847076|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847077|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847078|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847079|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847080|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847081|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847082|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847083|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847084|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847085|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847086|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847087|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847088|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847089|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847090|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847091|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847092|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847093|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847094|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847095|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847096|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847097|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847098|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847099|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847100|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847101|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847102|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847103|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847104|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847105|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847106|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847107|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847108|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847109|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847110|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847111|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847112|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847113|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847114|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847115|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847116|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847117|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847118|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847119|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847120|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847121|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847122|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847123|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847124|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847125|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847126|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847127|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847128|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847129|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847130|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847131|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847132|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847133|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847134|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847135|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847136|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847137|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847138|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847139|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847140|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847141|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847142|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847143|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847144|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847145|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847146|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847147|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847148|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847149|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847150|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847151|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847152|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847153|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847154|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847155|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847156|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847157|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847158|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847159|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847160|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847161|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847162|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847163|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847164|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847165|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847166|NCT01241591|O4|Outcome|Placebo BID + Placebo BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847167|NCT01241591|O3|Outcome|Placebo BID + Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID, at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847168|NCT01241591|O2|Outcome|CP-690,550 10 mg BID + Placebo BIW|Participants received CP-690,550 10 mg tablets, orally, BID, at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847169|NCT01241591|O1|Outcome|CP-690,550 5 mg Twice Daily (BID)+Placebo Twice Weekly (BIW)|Participants received CP-690,550 5 mg tablets, orally, BID, at approximately 12-hour intervals and placebo subcutaneous (SC) injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847170|NCT01241591|E4|Reported Event|Placebo|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847171|NCT01241591|E3|Reported Event|Etanercept 50 mg BIW|Participants received matching placebo tablets, orally, BID at approximately 12-hour intervals and etanercept 50 mg SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847172|NCT01241591|E2|Reported Event|CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847173|NCT01241591|E1|Reported Event|CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets, orally, BID at approximately 12-hour intervals and placebo SC injections BIW at approximately 3- to 4-day intervals for 12 weeks.
847174|NCT01241565|B1|Baseline|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
847175|NCT01241565|P1|Participant Flow|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
847176|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
847177|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
847178|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
847179|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
847180|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|"Single arm study, all patients will receive the study device.~ENDO GIA™ Stapler with TRI-STAPLE™ Technology: All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology"
847181|NCT01241565|O1|Outcome|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
847182|NCT01241565|E1|Reported Event|ENDO GIA™ Stapler With TRI-STAPLE™ Technology|Single arm study, all patients will receive the study device.
847183|NCT01241552|B5|Baseline|Total|Total of all reporting groups
847184|NCT01241552|B4|Baseline|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847185|NCT01241552|B3|Baseline|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847186|NCT01241552|B2|Baseline|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847187|NCT01241552|B1|Baseline|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847188|NCT01241552|P4|Participant Flow|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847189|NCT01241552|P3|Participant Flow|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847191|NCT01241552|P1|Participant Flow|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care (SOC) for CDI
847192|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847193|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847194|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847195|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847196|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847197|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847198|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847199|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847200|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847201|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847202|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847203|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847204|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847205|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847206|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847207|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847208|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847209|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847210|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847211|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847212|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847213|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847214|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847215|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847216|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847217|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847218|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847219|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847220|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847221|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847222|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847223|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847224|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847225|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847226|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847227|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847228|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847229|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847230|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847231|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847232|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847233|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847234|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847235|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847236|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847237|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847238|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847239|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847240|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847241|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847242|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847243|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847244|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847245|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847246|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847247|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847248|NCT01241552|O4|Outcome|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + Standard of Care for CDI
847249|NCT01241552|O3|Outcome|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK-3415A + Standard of Care for CDI
847250|NCT01241552|O2|Outcome|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + Standard of Care for CDI
847251|NCT01241552|O1|Outcome|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + Standard of Care for CDI
847252|NCT01241552|E4|Reported Event|Placebo + SOC|Normal saline infusion (0.9% sodium chloride) + SOC for CDI
847253|NCT01241552|E3|Reported Event|MK-3415A + SOC|Single IV infusion of 10 mg/kg MK 3415A + SOC for CDI
847254|NCT01241552|E2|Reported Event|MK-6072 + SOC|Single IV infusion of 10 mg/kg MK-6072 + SOC for CDI
847255|NCT01241552|E1|Reported Event|MK-3415 + SOC|Single intravenous (IV) infusion of 10 mg/kg MK-3415 + SOC for CDI
847256|NCT01241539|B1|Baseline|Dabigatran|Dabigatran treated patients
847257|NCT01241539|P1|Participant Flow|Dabigatran|Period 1 target blood flow rate during dialysis was 200mL/min. Period 2 target blood flow rate during dialysis was 400mL/min.
847258|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
847259|NCT01241539|O1|Outcome|Dabigatran|Dabigatran treated patients
847260|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
847261|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
847262|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
847263|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
847264|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
847265|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
847266|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
847267|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
847268|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
847269|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
847270|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
847271|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
847272|NCT01241539|O2|Outcome|Dabigatran P2|Period 2 target blood flow rate during dialysis was 400mL/min
847273|NCT01241539|O1|Outcome|Dabigatran P1|Period 1 target blood flow rate during dialysis was 200mL/min
847274|NCT01241539|E1|Reported Event|Dabigatran|Dabigatran treated patients
847275|NCT01241513|B3|Baseline|Total|Total of all reporting groups
847276|NCT01241513|B2|Baseline|Placebo|Placebo
847277|NCT01241513|B1|Baseline|N-acetylcysteine (NAC)|NAC
847278|NCT01241513|P2|Participant Flow|Placebo|Placebo
847279|NCT01241513|P1|Participant Flow|N-acetylcysteine|Active drug group
847280|NCT01241513|O2|Outcome|NAC Group|N-acetyl-L-Cysteine (800 mg T.I.D. in diet soda) for 4 days
847281|NCT01241513|O1|Outcome|Placebo Group|Placebo (Diet soda only)
847282|NCT01241513|E1|Reported Event|NAC Group and Placebo Group|
847283|NCT01241292|B3|Baseline|Total|Total of all reporting groups
847320|NCT01241240|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
847321|NCT01241240|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
847605|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847284|NCT01241292|B2|Baseline|Elotuzumab 20 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847285|NCT01241292|B1|Baseline|Elotuzumab 10 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847328|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
847329|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
847286|NCT01241292|P2|Participant Flow|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
847287|NCT01241292|P1|Participant Flow|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
847288|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847289|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847290|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
847291|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
847386|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
883491|NCT01136356|O1|Outcome|Morphine|
847292|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847293|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847294|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847295|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847296|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847297|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847298|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847299|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847300|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847696|NCT01240785|B3|Baseline|Total|Total of all reporting groups
847301|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847302|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was administered IV at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847303|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was administered IV at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered PO once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered PO as a single dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) and 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847304|NCT01241292|O2|Outcome|Elotuzumab 20 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 20 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of:~28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847305|NCT01241292|O1|Outcome|Elotuzumab 10 mg/kg|"Elotuzumab was intravenously (IV) injected at a dose of 10 mg/kg weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity became apparent.~Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. The dose of lenalidomide was administered at least 2-4 hours after completion of elotuzumab infusion.~On weeks without elotuzumab administration, dexamethasone was administered as a single dose of 40 mg PO. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of:~28 mg PO (between 3 to 24 hours prior to the start of the elotuzumab infusion) AND 8 mg IV (At least 45 min prior to the start of the elotuzumab infusion)."
847306|NCT01241292|E2|Reported Event|Elotuzumab 20mg/kg|Elotuzumab 20 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
847307|NCT01241292|E1|Reported Event|Elotuzumab 10mg/kg|Elotuzumab 10 mg/kg was intravenously (IV) given weekly (Days 1, 8, 15 and 22 of 4-week cycle) for the first 2 cycles and bi-weekly (every 2 weeks) (Day 1 and Day 15) thereafter until disease progression or unacceptable toxicity. Elotuzumab was first given at 10 mg/kg. If all participants completed the first cycle and none experienced a dose limiting toxicity (DLT), the dose was escalated to 20 mg/kg. If 1 experienced a DLT at 10 mg/kg, 3 additional participants were assigned to 10 mg/kg. If no additional participants experienced a DLT, the dose was escalated to 20 mg/kg. Lenalidomide 25 mg was administered orally once daily for the first 3 weeks of each 4-week cycle. On weeks without elotuzumab, dexamethasone was administered as a single oral (PO) dose of 40 mg. On weeks of elotuzumab infusion, the weekly dose of dexamethasone was administered as a split dose of: 28 mg PO (3 to 24 hours prior to the start of elotuzumab) and 8 mg IV (45 min prior to start of elotuzumab).
847308|NCT01241279|B3|Baseline|Total|Total of all reporting groups
847309|NCT01241279|B2|Baseline|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
847310|NCT01241279|B1|Baseline|Crystalens AO|A silicone multi-piece accommodating intraocular lens
847311|NCT01241279|P2|Participant Flow|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
847312|NCT01241279|P1|Participant Flow|Crystalens AO|A silicone multi-piece accommodating intraocular lens
847313|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
847314|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
847315|NCT01241279|O2|Outcome|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
847316|NCT01241279|O1|Outcome|Crystalens AO|A silicone multi-piece accommodating intraocular lens
847317|NCT01241279|E2|Reported Event|SoftPort LI61AO|A silicone multi-piece foldable aspheric intraocular lens
847318|NCT01241279|E1|Reported Event|Crystalens AO|A silicone multi-piece accommodating intraocular lens
847319|NCT01241240|B3|Baseline|Total|Total of all reporting groups
847322|NCT01241240|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
847323|NCT01241240|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
847324|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
847325|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
847326|NCT01241240|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
847327|NCT01241240|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
847330|NCT01241240|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
847331|NCT01241240|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
847332|NCT01240915|B9|Baseline|Total|Total of all reporting groups
847333|NCT01240915|B8|Baseline|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847334|NCT01240915|B7|Baseline|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847335|NCT01240915|B6|Baseline|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847336|NCT01240915|B5|Baseline|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847337|NCT01240915|B4|Baseline|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847338|NCT01240915|B3|Baseline|Cohort 1: MultiStem 300 or MultiStem 300 (x3), Placebo|Participants received either a single dose of MultiStem 300 Million Cells infusion on Day 1 or 3 doses on Day 1, Week 1, and Week 2; followed by a single dose of placebo infusion at Week 8.
847339|NCT01240915|B2|Baseline|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847340|NCT01240915|B1|Baseline|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847341|NCT01240915|P9|Participant Flow|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847342|NCT01240915|P8|Participant Flow|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847343|NCT01240915|P7|Participant Flow|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847344|NCT01240915|P6|Participant Flow|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847345|NCT01240915|P5|Participant Flow|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847346|NCT01240915|P4|Participant Flow|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847347|NCT01240915|P3|Participant Flow|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847348|NCT01240915|P2|Participant Flow|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847349|NCT01240915|P1|Participant Flow|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847350|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847351|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847352|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
848590|NCT01236365|E1|Reported Event|Atorvastatin|Atorvastatin: 10 or 20 mg daily
847353|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847354|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847355|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847356|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847357|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847358|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847359|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847360|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847361|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847362|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847363|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847364|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847365|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847366|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847367|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847368|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847369|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847370|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847371|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847372|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847373|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847374|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847375|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847376|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847377|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847378|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847379|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847380|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847381|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847382|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847383|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847384|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847385|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
848591|NCT01236339|B3|Baseline|Total|Total of all reporting groups
847387|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847388|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847389|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847390|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847391|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847392|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847393|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847394|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847395|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847396|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847397|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847398|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847399|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847400|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847401|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847402|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847403|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847404|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847405|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847406|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847407|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847408|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847409|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847410|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847411|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847412|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847413|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847414|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847415|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847416|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847417|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847418|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847419|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
850856|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
847420|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847421|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847422|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847423|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847424|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847425|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847426|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847427|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847428|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847429|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847430|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847431|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847432|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847433|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847434|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847435|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847436|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847437|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847438|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847439|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847440|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847441|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847442|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847443|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847444|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847445|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847446|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847447|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847448|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847449|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847450|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847451|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847452|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
850857|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
847453|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847454|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847455|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847456|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847457|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847458|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847459|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847460|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847461|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847462|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847463|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847464|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847465|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847466|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847467|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847468|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847469|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847470|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847471|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847472|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847473|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847474|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847475|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847476|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847477|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847478|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847479|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847480|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847481|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847482|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847483|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847484|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847485|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
850858|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
847486|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847487|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847488|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847489|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847490|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847491|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847492|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847493|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847494|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847495|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847496|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847497|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847498|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847499|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847500|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847501|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847502|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847503|NCT01240915|O9|Outcome|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847504|NCT01240915|O8|Outcome|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847505|NCT01240915|O7|Outcome|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847506|NCT01240915|O6|Outcome|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847507|NCT01240915|O5|Outcome|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847508|NCT01240915|O4|Outcome|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847509|NCT01240915|O3|Outcome|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847510|NCT01240915|O2|Outcome|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847511|NCT01240915|O1|Outcome|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847512|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
847513|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
847514|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
847515|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
847516|NCT01240915|O2|Outcome|Pooled Placebo|All participants who received placebo infusion on Day 1 in Cohort 3.
847517|NCT01240915|O1|Outcome|Pooled MultiStem|All participants who received MultiStem 750 Million Cells infusion on Day 1 in Cohort 3.
847518|NCT01240915|E9|Reported Event|Cohort 3: Placebo, Placebo|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847519|NCT01240915|E8|Reported Event|Cohort 3: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847520|NCT01240915|E7|Reported Event|Cohort 3: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847604|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847521|NCT01240915|E6|Reported Event|Cohort 3: MultiStem 750, MultiStem 750|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847522|NCT01240915|E5|Reported Event|Cohort 2: MultiStem 750, Placebo|Participants received a single dose of MultiStem 750 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847523|NCT01240915|E4|Reported Event|Cohort 1: MultiStem 300 (x3), Placebo|Participants received up to 3 doses of MultiStem 300 Million Cells infusion (Day 1, Week, Week 2), followed by a single dose of placebo infusion at Week 8.
847524|NCT01240915|E3|Reported Event|Cohort 1: MultiStem 300, Placebo|Participants received a single dose of MultiStem 300 Million Cells infusion on Day 1, followed by a single dose of placebo infusion at Week 8.
847525|NCT01240915|E2|Reported Event|Cohort 2: Placebo, MultiStem 750|Participants received a single dose of placebo infusion on Day 1, followed by a single dose of MultiStem 750 Million Cells infusion at Week 8.
847526|NCT01240915|E1|Reported Event|Cohort 1: Placebo, MultiStem 300|Participants received a single dose (Day 1) or 3 doses (Day 1, Week 1, Week 2) of placebo infusion, followed by a single dose of MultiStem 300 Million Cells infusion at Week 8.
847527|NCT01240902|B5|Baseline|Total|Total of all reporting groups
847528|NCT01240902|B4|Baseline|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847529|NCT01240902|B3|Baseline|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847530|NCT01240902|B2|Baseline|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847531|NCT01240902|B1|Baseline|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847532|NCT01240902|P4|Participant Flow|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847533|NCT01240902|P3|Participant Flow|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847534|NCT01240902|P2|Participant Flow|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847535|NCT01240902|P1|Participant Flow|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847536|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847537|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847538|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847539|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847540|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847541|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847542|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847543|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847544|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847545|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847546|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847547|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847548|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847549|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847550|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847551|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847552|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847553|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847554|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847555|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847556|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847557|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847558|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847559|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847560|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847561|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
911794|NCT01055704|O4|Outcome|Placebo|
847562|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847563|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847564|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847565|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847566|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847567|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847568|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847569|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847570|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847571|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847572|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
851441|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
847573|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847574|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847575|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847576|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847577|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847578|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847579|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847580|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847581|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847582|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847583|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847584|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847585|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847586|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847587|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847588|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847589|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847590|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847591|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847592|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847593|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847594|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847595|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847596|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847597|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847598|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847599|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847600|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847601|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847602|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847603|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
850859|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
847606|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847607|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847608|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847609|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847610|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847611|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847612|NCT01240902|O4|Outcome|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847613|NCT01240902|O3|Outcome|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847614|NCT01240902|O2|Outcome|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847615|NCT01240902|O1|Outcome|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847616|NCT01240902|E4|Reported Event|High Risk: SAVR|High Risk Surgical Patients: Surgical Aortic Valve Replacement (SAVR)
847617|NCT01240902|E3|Reported Event|High Risk: TAVI|High Risk Surgical Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
847618|NCT01240902|E2|Reported Event|Extreme Risk: TAVI Non-Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Non-Iliofemoral Access
847619|NCT01240902|E1|Reported Event|Extreme Risk: TAVI Iliofemoral|Extreme Risk Patients: Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI); Iliofemoral Access
847620|NCT01240863|B3|Baseline|Total|Total of all reporting groups
847621|NCT01240863|B2|Baseline|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847622|NCT01240863|B1|Baseline|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847623|NCT01240863|P3|Participant Flow|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847624|NCT01240863|P2|Participant Flow|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847625|NCT01240863|P1|Participant Flow|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
847626|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847627|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847628|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847629|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847630|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847631|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847632|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847697|NCT01240785|B2|Baseline|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847633|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847634|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847635|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847636|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847654|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
938575|NCT00984308|O2|Outcome|Control|
847637|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847638|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847639|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847640|NCT01240863|O4|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847641|NCT01240863|O3|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847642|NCT01240863|O2|Outcome|Open-Label Titration: Opioid Experienced|"During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid experienced participants switched from their current opioid medications to the calculated dose of hydrocodone extended release tablets based on an equianalgesic dose-conversion scheme.~A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped to 30 mg or 45 mg or 60 mg, or 90 mg every 12 hours until stable pain relief was obtained. The escalated dose was dependent upon the initial calculated equivalent dose."
847643|NCT01240863|O1|Outcome|Open-Label Titration: Opioid Naive|During the open label titration period, all participants received hydrocodone extended release tablets on an open-label basis. Opioid naïve participants (ie, those taking less than 10 mg/day of oxycodone or equivalent, during the 14 days before screening) started at a 15 mg dose of hydrocodone extended release, administered every 12 hours. A decision regarding dose adjustment was made based on whether the criterion of successful dose (ie, dose that produced stable pain relief) was met. In general, dose escalation stepped from 15 mg to 30 mg, 45 mg, 60 mg, and 90 mg every 12 hours until stable pain relief was obtained.
847644|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered ER hydrocodone tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847645|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847646|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847647|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847648|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847649|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847698|NCT01240785|B1|Baseline|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847699|NCT01240785|P2|Participant Flow|Insulin|
847650|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847651|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847652|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847653|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847655|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847656|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847657|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847658|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847659|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847660|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847661|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847662|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847663|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847664|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847665|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847666|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847667|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847668|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847700|NCT01240785|P1|Participant Flow|Metformin Arm|
958698|NCT00930761|B1|Baseline|Control|
847669|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847670|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847671|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847672|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847710|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847711|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847673|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847674|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847675|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847676|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847677|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847678|NCT01240863|O2|Outcome|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847679|NCT01240863|O1|Outcome|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets every 12 hours that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847680|NCT01240863|E3|Reported Event|Hydrocodone ER (Double-blind Treatment Period)|Participants were administered hydrocodone ER tablets at a dosage deemed successful for managing their pain during the titration period. Dosages of 15, 30, 45, 60, or 90 mg every 12 hours were given for 12 weeks during the double-blind period.
847681|NCT01240863|E2|Reported Event|Placebo (Double-blind Treatment Period)|Participants were administered placebo tablets twice a day that matched the dosage deemed successful for managing their pain during the titration period. A step wise, double-blind tapering schedule was implemented during the first 2 weeks of the 12 week, double blind, placebo controlled treatment period to reduce the risk of withdrawal effects in patients randomly assigned to placebo.
847682|NCT01240863|E1|Reported Event|Hydrocodone ER (Open-Label Titration Period)|All enrolled participants entered the open label titration period and received hydrocodone extended release (ER) tablets beginning with 15 mg every 12 hours for 3 to 7 days. Dosages were titrated upward until pain was effectively controlled. If an effective dosage between 15 mg - 90 mg twice a day was not identified within 6 week, the participant was withdrawn.
847683|NCT01240811|B4|Baseline|Total|Total of all reporting groups
847684|NCT01240811|B3|Baseline|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
847685|NCT01240811|B2|Baseline|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
847686|NCT01240811|B1|Baseline|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
847687|NCT01240811|P3|Participant Flow|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
847688|NCT01240811|P2|Participant Flow|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
847689|NCT01240811|P1|Participant Flow|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
847690|NCT01240811|O3|Outcome|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
847691|NCT01240811|O2|Outcome|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
847692|NCT01240811|O1|Outcome|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
847693|NCT01240811|E3|Reported Event|Copper T380A IUD|Healthy volunteers seeking contraception with IUD. Randomized to Copper T380A IUD.
847694|NCT01240811|E2|Reported Event|Levonorgestrel IUS|Healthy volunteers seeking contraception with IUD. Randomized to LNG IUS.
847695|NCT01240811|E1|Reported Event|Control-No IUD|Healthy volunteers not at risk of pregnancy and not using any hormonal contraception.
847701|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847702|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847703|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847704|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847705|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847706|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847707|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847708|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847709|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847712|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847713|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847714|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847715|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847716|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847717|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847718|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847719|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847720|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847721|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847722|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847723|NCT01240785|O2|Outcome|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847724|NCT01240785|O1|Outcome|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847725|NCT01240785|E2|Reported Event|Insulin|insulin: subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
847726|NCT01240785|E1|Reported Event|Metformin|metformin: metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
847727|NCT01240746|B4|Baseline|Total|Total of all reporting groups
847728|NCT01240746|B3|Baseline|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847729|NCT01240746|B2|Baseline|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847730|NCT01240746|B1|Baseline|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847731|NCT01240746|P3|Participant Flow|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847732|NCT01240746|P2|Participant Flow|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847733|NCT01240746|P1|Participant Flow|Study Group 1 (2010-2011 Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen.
847734|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847735|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847736|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847737|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847738|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847739|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847740|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
850860|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
847741|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847742|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847743|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847744|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847745|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847746|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847747|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847748|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847749|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
940130|NCT00980174|O1|Outcome|Placebo|
847750|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847751|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847752|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847753|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847754|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847755|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847756|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847757|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847758|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847759|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847760|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847761|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847762|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847763|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847764|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847765|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847766|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847767|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847768|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847769|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847770|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847771|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847772|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847773|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847774|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847775|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847776|NCT01240746|O3|Outcome|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847777|NCT01240746|O2|Outcome|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847778|NCT01240746|O1|Outcome|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847779|NCT01240746|E3|Reported Event|Study Group 3 (Investigational Quadrivalent Influenza Vaccine)|Participants received the Investigational Quadrivalent Influenza Vaccine (QIV)
847780|NCT01240746|E2|Reported Event|Study Group 2 (Investigational Trivalent Influenza Vaccine)|Participants received the Investigational Trivalent Influenza Vaccine (TIV) containing the alternate B strain influenza antigen
847781|NCT01240746|E1|Reported Event|Study Group 1 (Trivalent Influenza Vaccine)|Participants received the Licensed 2010-2011 Trivalent Influenza Vaccine (TIV) containing the primary B strain influenza antigen
847782|NCT01240590|B6|Baseline|Total|Total of all reporting groups
847783|NCT01240590|B5|Baseline|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
847784|NCT01240590|B4|Baseline|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
847785|NCT01240590|B3|Baseline|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
847786|NCT01240590|B2|Baseline|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
851442|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
847787|NCT01240590|B1|Baseline|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
847788|NCT01240590|P5|Participant Flow|Level 4: Cisplatin|100mg/m(2) Cisplatin Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
847789|NCT01240590|P4|Participant Flow|Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
847790|NCT01240590|P3|Participant Flow|Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
847791|NCT01240590|P2|Participant Flow|Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
847792|NCT01240590|P1|Participant Flow|Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin Drug: Crolibulin Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2) Drug: Cisplatin Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
847793|NCT01240590|O5|Outcome|Ph II Level 4: Cisplatin|"100mg/m(2) Cisplatin~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
847794|NCT01240590|O4|Outcome|Ph II Level 3: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
847795|NCT01240590|O3|Outcome|Ph I Level 2: Cisplatin + Crolibulin|"100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
847796|NCT01240590|O2|Outcome|Ph I Level 1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
847797|NCT01240590|O1|Outcome|Ph I Level -1: Cisplatin + Crolibulin|"75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin~Crolibulin: Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)~Cisplatin: Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)"
847798|NCT01240590|O5|Outcome|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
847799|NCT01240590|O4|Outcome|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
847800|NCT01240590|O3|Outcome|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
847801|NCT01240590|O2|Outcome|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
847802|NCT01240590|O1|Outcome|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
847803|NCT01240590|O5|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
847804|NCT01240590|O4|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
847805|NCT01240590|O3|Outcome|Ph I Level 2: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
847806|NCT01240590|O2|Outcome|Ph I Level 1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
847807|NCT01240590|O1|Outcome|Ph I Level -1: Cisplatin + Crolibulin|75mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
847808|NCT01240590|O2|Outcome|Ph II Level 4: Cisplatin|100mg/m(2) Cisplatin
847809|NCT01240590|O1|Outcome|Ph II Level 3: Cisplatin + Crolibulin|100mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
847810|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 8-20 mg/m(2)crolibulin intravenously.
847811|NCT01240590|O1|Outcome|All Participants|All participants who received at least one dose of 75-100 mg/m(2) cisplatin intravenously.
847812|NCT01240590|E5|Reported Event|Ph II Level: 4 Cisplatin|100 mg/m(2) Cisplatin
847813|NCT01240590|E4|Reported Event|Ph II Level: 3 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 20 mg/m(2) Crolibulin
847814|NCT01240590|E3|Reported Event|Ph I Level: 2 Cisplatin & Crolibulin|100 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
847815|NCT01240590|E2|Reported Event|Ph I Level: 1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 13 mg/m(2) Crolibulin
847816|NCT01240590|E1|Reported Event|Ph I Level: -1 Cisplatin & Crolibulin|75 mg/m(2) Cisplatin + 8 mg/m(2) Crolibulin
847817|NCT01240551|B3|Baseline|Total|Total of all reporting groups
847818|NCT01240551|B2|Baseline|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847819|NCT01240551|B1|Baseline|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847854|NCT01240330|P1|Participant Flow|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
847820|NCT01240551|P2|Participant Flow|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847821|NCT01240551|P1|Participant Flow|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847822|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847823|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847824|NCT01240551|O2|Outcome|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847825|NCT01240551|O1|Outcome|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847826|NCT01240551|E2|Reported Event|No-Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847827|NCT01240551|E1|Reported Event|Mets Via NaF-18 PET/CT|F-18 NaF: All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
847828|NCT01240382|B3|Baseline|Total|Total of all reporting groups
847829|NCT01240382|B2|Baseline|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
847830|NCT01240382|B1|Baseline|3% DE-089|3% DE-089 ophthalmic solution
847831|NCT01240382|P2|Participant Flow|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
847832|NCT01240382|P1|Participant Flow|3% DE-089|3% DE-089 ophthalmic solution
847833|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
847834|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
847835|NCT01240382|O2|Outcome|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
847836|NCT01240382|O1|Outcome|3% DE-089|3% DE-089 ophthalmic solution
847837|NCT01240382|E2|Reported Event|0.1% HA|0.1% sodium hyaluronate ophthalmic solution
847838|NCT01240382|E1|Reported Event|3% DE-089|3% DE-089 ophthalmic solution
847839|NCT01240356|B3|Baseline|Total|Total of all reporting groups
847840|NCT01240356|B2|Baseline|Phase II|Phase II-20 patients with ischemic stroke treated with IV-tPA
847841|NCT01240356|B1|Baseline|Phase I|Non-stroke volunteers.
847842|NCT01240356|P2|Participant Flow|Phase II|Acute Ischemic Stroke patients received standard-doce intravenous tissue-type plasminogen activator (tPA) within 0-3 hours window.
847843|NCT01240356|P1|Participant Flow|Phase I|Non-stroke volunteers.
847844|NCT01240356|O1|Outcome|Phase I: Healthy Volunteers|Phase I - A group of 15 Non-stroke healthy volunteers.
847845|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
847846|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
847847|NCT01240356|O1|Outcome|Phase II - Iscehmic Stroke Patients|Phase II - 20 patients with ischemic stroke treated with IV-tPA
847848|NCT01240356|O1|Outcome|Phase 1 (Healthy Volunteers)|Phase I - A group of non-stroke healthy volunteers.
847849|NCT01240356|O1|Outcome|Phase II - Ischemic Stroke Patients|Phase II - A group of 20 patients with ischemic stroke treated with IV-tPA
847850|NCT01240356|O1|Outcome|Phase I|Non stroke patients
847851|NCT01240356|E2|Reported Event|Phase II - Ischemic Stroke Patients|Phase II - 20 patient with ischemic stroke treated with IV-tPA
847852|NCT01240356|E1|Reported Event|Phase I: Healthy Volunteers|Phase I - 15 non-stroke healthy volunteers.
847853|NCT01240330|B1|Baseline|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
847887|NCT01239992|P1|Participant Flow|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
847888|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
851443|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
847855|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
847856|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
847857|NCT01240330|O1|Outcome|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
847858|NCT01240330|E1|Reported Event|Pneumatic Compression Therapy|The Vasculaire System provided compression therapy to the foot and calf of the participant's right leg. The system compressed and released the foot and calf to increase blood flow and circulation of the participant's right limb. Ten cycles of compression therapy was applied. Increase in blood flow rate was measured in the participants femoral vein using duplex ultrasonography.
847859|NCT01240200|B3|Baseline|Total|Total of all reporting groups
847860|NCT01240200|B2|Baseline|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Glargine SoloSTAR® pen in Period 1 and Glargine vial and syringe in Period 2.
847861|NCT01240200|B1|Baseline|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Glargine vial and syringe in Period 1 and Glargine SoloSTAR pen in Period 2.
847862|NCT01240200|P2|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
847863|NCT01240200|P1|Participant Flow|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
847864|NCT01240200|O2|Outcome|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
847865|NCT01240200|O1|Outcome|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
847866|NCT01240200|E2|Reported Event|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine SoloSTAR® pen in Period 1 and Insulin glargine vial and syringe in Period 2.
847867|NCT01240200|E1|Reported Event|Vial & Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Insulin glargine vial and syringe in Period 1 and Insulin glargine SoloSTAR pen in Period 2.
847868|NCT01240135|B3|Baseline|Total|Total of all reporting groups
847869|NCT01240135|B2|Baseline|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
847870|NCT01240135|B1|Baseline|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
847871|NCT01240135|P2|Participant Flow|Renu Fresh / FID 114675A|Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
847872|NCT01240135|P1|Participant Flow|FID 114576A / Renu Fresh|FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
847873|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
847874|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
847875|NCT01240135|O2|Outcome|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
847876|NCT01240135|O1|Outcome|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
847877|NCT01240135|E2|Reported Event|Renu Fresh|Renu fresh used for contact lens care per protocol-specified instructions for 14 days.
847878|NCT01240135|E1|Reported Event|FID 114576A|FID 114675A used for contact lens care per protocol-specified instructions for 14 days.
847879|NCT01240122|B1|Baseline|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
847880|NCT01240122|P1|Participant Flow|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
847881|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both the Investigational MPS and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
847882|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and was tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
847883|NCT01240122|O2|Outcome|Investigational MPS|Paired/parallel eye evaluation; each subject used both used the Investigational MPS and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
847884|NCT01240122|O1|Outcome|Biotrue|Paired/parallel eye evaluation; each subject was treated with Biotrue, and were tested at 1 hour, 2 hours, 4 hours and end of day during a 4 day period.
847885|NCT01240122|E1|Reported Event|Biotrue/Investigational MPS|Paired/parallel eye evaluation; each subject used both study treatments and were tested at 1 hour, 2hours, 4 hours and end of day during a 4 day period.
847886|NCT01239992|B1|Baseline|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
847889|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
847890|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
847891|NCT01239992|O1|Outcome|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
847892|NCT01239992|E1|Reported Event|Niacin/ Laropiprant|Niacin/ Laropiprant: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
847893|NCT01239797|B3|Baseline|Total|Total of all reporting groups
847894|NCT01239797|B2|Baseline|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
847895|NCT01239797|B1|Baseline|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
847896|NCT01239797|P2|Participant Flow|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
847897|NCT01239797|P1|Participant Flow|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
847898|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
847899|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
847900|NCT01239797|O2|Outcome|Lenalidomide + Dexamethasone|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug"
847960|NCT01239355|P1|Participant Flow|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
847961|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
847901|NCT01239797|O1|Outcome|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug~Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
847902|NCT01239797|E2|Reported Event|Lenalidomide + Dexamethasone|Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug Dexamethasone: Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22 Regimen repeated every 28 days until participants met criteria for discontinuation of study drug
847969|NCT01239342|P1|Participant Flow|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847970|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847971|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847972|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847903|NCT01239797|E1|Reported Event|Lenalidomide + Dexamethasone + Elotuzumab|"Lenalidomide: Capsules, Oral, 25 mg, once daily, on Days 1-21 Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (Oral):~On weeks without Elotuzumab dosing: Tablets, Oral, 40mg Repeat every 28 days until participants met criteria for discontinuation of study drug On weeks with Elotuzumab dosing: Tablets, Oral, 28 mg Repeat every 28 days until participants met criteria for discontinuation of study drug~Dexamethasone (IV):~On weeks without Elotuzumab dosing: Not Applicable (N/A) On weeks with Elotuzumab dosing: Solution, Intravenous (IV), 8 mg, weekly Repeat every 28 days until participants met criteria for discontinuation of study drug Elotuzumab (BMS-901608; HuLuc63): Solution, IV, 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3 and beyond) Repeat every 28 days until participants met criteria for discontinuation of study drug"
847904|NCT01239745|B1|Baseline|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847905|NCT01239745|P1|Participant Flow|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847906|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847907|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847908|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847909|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847910|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847911|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847912|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847913|NCT01239745|O1|Outcome|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847914|NCT01239745|E1|Reported Event|Exemestane|Participants received exemestane (Aromasin) in accordance with Summary of Product Characteristics (SmPC) and adjusted according to medical and therapeutic necessity in a sequential adjuvant hormonal therapy (tamoxifen followed by Aromasin) up to 5 years or until tumor relapse occurred.
847915|NCT01239732|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847962|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
847963|NCT01239355|O1|Outcome|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
847916|NCT01239732|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 milligram per square meter (mg/m^2) IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (area under the plasma concentration-time curve [AUC] 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847973|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847974|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847917|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847918|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847919|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847920|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847921|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847922|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847923|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
848201|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
847924|NCT01239732|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
848021|NCT01239043|B3|Baseline|Total|Total of all reporting groups
847925|NCT01239732|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Participants received bevacizumab 15 mg/kg IV on Day 1 every 3 weeks from Cycle 1 (1 cycle = 3 weeks) to Cycle 36 (initially concurrent with chemotherapy, then continued as a single agent following the completion of chemotherapy), or until protocol-defined disease progression or until unacceptable toxicity (whichever occurred first). The 15 mg/kg dose every 3 weeks was the recommended dose; however a dose of IV bevacizumab 7.5 mg/kg every 3 weeks was permissible, but was to be selected prior to the first dosing of bevacizumab. Participants received paclitaxel 175 mg/m^2 IV on Day 1 every 3 weeks or 80 mg/m^2 IV every week and carboplatin (AUC 5-6) IV on Day 1 every 3 weeks for a minimum of 4 and maximum of 8 cycles (including up to 4 pre-surgical cycles), or until protocol-defined disease progression, or unacceptable toxicity (whichever occurred first).
847926|NCT01239680|B3|Baseline|Total|Total of all reporting groups
847927|NCT01239680|B2|Baseline|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
847928|NCT01239680|B1|Baseline|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours
847929|NCT01239680|P2|Participant Flow|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours
847930|NCT01239680|P1|Participant Flow|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate Intravenous 1 liter once over 6 hours
847931|NCT01239680|O2|Outcome|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
847932|NCT01239680|O1|Outcome|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
847933|NCT01239680|E2|Reported Event|Glutamine: Intravenous 25 Grams Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional glutamine: Glutamine: Intravenous 25 grams once over 6 hours.
847934|NCT01239680|E1|Reported Event|Ringer's Lactate: Intravenous 1 Liter Once Over 6 Hours|Administration of Ringer's Lactate per Advanced Trauma Life Support Protocol with additional Ringer's Lactate: Ringer's Lactate: Intravenous 1 liter once over 6 hours.
847935|NCT01239511|B5|Baseline|Total|Total of all reporting groups
847936|NCT01239511|B4|Baseline|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
847937|NCT01239511|B3|Baseline|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
847938|NCT01239511|B2|Baseline|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
847939|NCT01239511|B1|Baseline|Placebo Group|placebo capsule 2# t.i.d./day
847940|NCT01239511|P4|Participant Flow|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
847941|NCT01239511|P3|Participant Flow|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
847942|NCT01239511|P2|Participant Flow|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
847943|NCT01239511|P1|Participant Flow|Placebo Group|placebo capsule 2# t.i.d./day
847944|NCT01239511|O4|Outcome|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
847945|NCT01239511|O3|Outcome|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
847946|NCT01239511|O2|Outcome|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
847947|NCT01239511|O1|Outcome|Placebo Group|placebo capsule 2# t.i.d./day
847948|NCT01239511|E4|Reported Event|Treatment Group C|450 mg STA-2, 2 capsules t.i.d., after meal (2700 mg STA-2 total dose per day)
847949|NCT01239511|E3|Reported Event|Treatment Group B|300 mg STA-2, 2 capsules t.i.d., after meal (1800 mg STA-2 total dose per day)
847950|NCT01239511|E2|Reported Event|Treatment Group A|150 mg STA-2, 2 capsules t.i.d., after meal (900 mg STA-2 total dose per day)
847951|NCT01239511|E1|Reported Event|Placebo Group|placebo capsule 2# t.i.d./day
847952|NCT01239394|B1|Baseline|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
847953|NCT01239394|P1|Participant Flow|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
847954|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
847955|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
847956|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
847957|NCT01239394|O1|Outcome|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
847958|NCT01239394|E1|Reported Event|Ofatumumab|"single-arm, open-label, interventional~ofatumumab: Weekly infusion for 8 weeks"
847959|NCT01239355|B1|Baseline|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
847964|NCT01239355|E1|Reported Event|Treatment (Akt Inhibitor MK2206)|"Patients receive 200mg oral Akt inhibitor MK2206 on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Akt Inhibitor MK2206: Given PO~Laboratory Biomarker Analysis: Correlative studies"
847965|NCT01239342|B3|Baseline|Total|Total of all reporting groups
847966|NCT01239342|B2|Baseline|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847967|NCT01239342|B1|Baseline|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847968|NCT01239342|P2|Participant Flow|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
848247|NCT01238848|B1|Baseline|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
847975|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847976|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847977|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847978|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847979|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847980|NCT01239342|O2|Outcome|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847981|NCT01239342|O1|Outcome|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847982|NCT01239342|E2|Reported Event|Everolimus|Everolimus 10 mg orally once daily, courses repeat every 4 weeks.
847983|NCT01239342|E1|Reported Event|MK2206|Akt inhibitor MK2206 200 mg orally once weekly, courses repeat every 4 weeks.
847984|NCT01239316|B1|Baseline|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847985|NCT01239316|P1|Participant Flow|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847986|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847987|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847988|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847989|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847990|NCT01239316|O1|Outcome|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847991|NCT01239316|E1|Reported Event|Hh Pathway Activated|Pediatric patients with recurrent or refractory medulloblastoma with evidence of activation of Hedgehog (Hh) signaling pathway in their tumors.
847992|NCT01239212|B1|Baseline|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
847993|NCT01239212|P1|Participant Flow|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
847994|NCT01239212|O1|Outcome|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
847995|NCT01239212|E1|Reported Event|Single Arm, 50 mg/kg of Levetiracetam|Single arm, 50 mg/kg of levetiracetam
847996|NCT01239121|B4|Baseline|Total|Total of all reporting groups
847997|NCT01239121|B3|Baseline|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
847998|NCT01239121|B2|Baseline|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
847999|NCT01239121|B1|Baseline|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848000|NCT01239121|P3|Participant Flow|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848001|NCT01239121|P2|Participant Flow|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
848002|NCT01239121|P1|Participant Flow|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848003|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848004|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
848005|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848022|NCT01239043|B2|Baseline|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848248|NCT01238848|P2|Participant Flow|Normal|Normal saline (sodium chloride 0.9%) + albuterol
848006|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848007|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
848008|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848009|NCT01239121|O3|Outcome|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848010|NCT01239121|O2|Outcome|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
848011|NCT01239121|O1|Outcome|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848012|NCT01239121|E3|Reported Event|Pilot HIE-Enhanced Outpatient Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans seen as outpatients in Geriatrics Primary care clinic~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848013|NCT01239121|E2|Reported Event|Optimal Medication Reconciliation Without HIE|"Optimal Medication Reconciliation without Health Information Exchange (HIE) for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~Optimal Medication Reconciliation without HIE: Medication reconciliation implemented by a pharmacist without regional health information exchange"
848014|NCT01239121|E1|Reported Event|HIE-Enhanced Medication Reconciliation|"Health Information Exchange (HIE)-Enhanced Medication Reconciliation for veterans admitted to James J Peters VA hospital units 6B, 7B, 7C, and 8B (each unit crossing over between intervention and control every 3-4 months)~HIE-Enhanced Medication Reconciliation: Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist"
848015|NCT01239056|B1|Baseline|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
848016|NCT01239056|P1|Participant Flow|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
848017|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
848018|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
848019|NCT01239056|O1|Outcome|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
848020|NCT01239056|E1|Reported Event|Pancreatic Pseudocysts|Patients underwent Endoscopic Ultrasound-guided pseudocyst transmural drainage using fully covered self-expanding metal stents (CSEMS). Next, patients underwent an Endoscopic retrograde cholangiopancreatography to evaluate for Pancreatic duct (PD) disruption. Patients then received an abdominal CT to assess pancreatic pseudocyst resolution. If complete resolution was noted, all stents were subsequently removed. If the pseudocyst was not resolved, stent removal was deferred and follow-up CTs were obtained at 2 to 4 week intervals until radiographic resolution was achieved.
848023|NCT01239043|B1|Baseline|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848024|NCT01239043|P2|Participant Flow|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848025|NCT01239043|P1|Participant Flow|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848026|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848027|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848028|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848029|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848030|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848031|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848032|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848033|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848034|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848035|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848036|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848037|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848038|NCT01239043|O2|Outcome|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848039|NCT01239043|O1|Outcome|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848040|NCT01239043|E2|Reported Event|Menactra® Vaccine Group|All participants had received Menactra® vaccine in Study MTA29 and received a single dose of Menactra® on Day 0 in the present trial.
848041|NCT01239043|E1|Reported Event|Menomune® Vaccine Group|All participants had received Menomune® vaccine in Study MTA29 and received a single dose of Menomune® on Day 0 in the present trial.
848042|NCT01238991|B11|Baseline|Total|Total of all reporting groups
848043|NCT01238991|B10|Baseline|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848044|NCT01238991|B9|Baseline|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848045|NCT01238991|B8|Baseline|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848046|NCT01238991|B7|Baseline|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848047|NCT01238991|B6|Baseline|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848048|NCT01238991|B5|Baseline|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848049|NCT01238991|B4|Baseline|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848202|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848050|NCT01238991|B3|Baseline|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848051|NCT01238991|B2|Baseline|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848052|NCT01238991|B1|Baseline|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848053|NCT01238991|P10|Participant Flow|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848054|NCT01238991|P9|Participant Flow|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848249|NCT01238848|P1|Participant Flow|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
851444|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
848055|NCT01238991|P8|Participant Flow|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848056|NCT01238991|P7|Participant Flow|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848057|NCT01238991|P6|Participant Flow|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848058|NCT01238991|P5|Participant Flow|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848059|NCT01238991|P4|Participant Flow|10 μg ACC-001+ (10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848060|NCT01238991|P3|Participant Flow|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848061|NCT01238991|P2|Participant Flow|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848062|NCT01238991|P1|Participant Flow|3 μg ACC-001+QS-21|A group of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848063|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
848064|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848065|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848066|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848067|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848068|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848069|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848070|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848071|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848072|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848073|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
848074|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848075|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848076|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848077|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848078|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848079|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848080|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848081|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848082|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848083|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
848084|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848085|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848086|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848087|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848088|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848089|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848090|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848091|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848092|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848093|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
848094|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848095|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848096|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848097|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848098|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848099|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848100|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848101|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848102|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848103|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
848104|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848105|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848296|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848106|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848107|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848108|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848109|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848110|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848111|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848112|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848113|NCT01238991|O10|Outcome|PBS+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21(50 μg) in this study (Day 1, month 6, 12, and 18)
848114|NCT01238991|O9|Outcome|QS-21+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848115|NCT01238991|O8|Outcome|30 μg ACC-001+(30 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001(30 μg) in the preceding studies and ACC-001(30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848116|NCT01238991|O7|Outcome|30 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848117|NCT01238991|O6|Outcome|PBS+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of PBS in the preceding studies and active vaccine ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848118|NCT01238991|O5|Outcome|QS-21+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848119|NCT01238991|O4|Outcome|10 μg ACC-001+(10 μg ACC-001+QS-21)|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848120|NCT01238991|O3|Outcome|10 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848121|NCT01238991|O2|Outcome|QS-21+(3 μg ACC-001+QS-21)|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848122|NCT01238991|O1|Outcome|3 μg ACC-001+QS-21|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848123|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848124|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848125|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848126|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848127|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848128|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848129|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848130|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848131|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848132|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848133|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848134|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848135|NCT01238991|O6|Outcome|30 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848136|NCT01238991|O5|Outcome|30 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848137|NCT01238991|O4|Outcome|10 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848208|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848138|NCT01238991|O3|Outcome|10 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001(10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848139|NCT01238991|O2|Outcome|3 μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848140|NCT01238991|O1|Outcome|3 μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848141|NCT01238991|E7|Reported Event|Total|All participants
848142|NCT01238991|E6|Reported Event|30μg Control|A group of participants who received IM injection of adjuvant QS-21(50 μg) or PBS in the preceding studies and active vaccine ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848143|NCT01238991|E5|Reported Event|30μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (30 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (30 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848144|NCT01238991|E4|Reported Event|10μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) or PBS in the preceding studies and active vaccine ACC-001(10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848145|NCT01238991|E3|Reported Event|10ug ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (10 μg) with or without adjuvant QS-21 (50 μg) in the preceding studies and ACC-001 (10 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848146|NCT01238991|E2|Reported Event|3μg Control|A group of participants who received IM injection of adjuvant QS-21 (50 μg) in the preceding studies and acctive vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) in this study (Day 1, month 6, 12, and 18)
848147|NCT01238991|E1|Reported Event|3μg ACC-001 Treat|A group of participants who received IM injection of active vaccine ACC-001 (3 μg) + adjuvant QS-21 (50 μg) both in the preceding studies and in this study (Day 1, month 6, 12, and 18)
848148|NCT01238900|B1|Baseline|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848149|NCT01238900|P1|Participant Flow|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848150|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848151|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848152|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848153|NCT01238900|O1|Outcome|Per- Protocol Analysis of Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848154|NCT01238900|O1|Outcome|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848155|NCT01238900|E1|Reported Event|Benign Biliary Strictures|Participants underwent Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of self-expandable metal stents (SEMS) in the bile duct.
848156|NCT01238861|B7|Baseline|Total|Total of all reporting groups
848157|NCT01238861|B6|Baseline|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848158|NCT01238861|B5|Baseline|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848159|NCT01238861|B4|Baseline|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848160|NCT01238861|B3|Baseline|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848161|NCT01238861|B2|Baseline|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848162|NCT01238861|B1|Baseline|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848163|NCT01238861|P6|Participant Flow|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
850861|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
848164|NCT01238861|P5|Participant Flow|Non-eosinophil Phenotype (EOS-) Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848165|NCT01238861|P4|Participant Flow|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848166|NCT01238861|P3|Participant Flow|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848167|NCT01238861|P2|Participant Flow|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
851445|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
848168|NCT01238861|P1|Participant Flow|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848169|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848170|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848171|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848172|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848173|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848174|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848175|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848176|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848177|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848178|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848179|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848180|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848181|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848182|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848183|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848184|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848185|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848186|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848187|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848188|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848189|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848190|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848191|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848192|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848193|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848194|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848195|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848196|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848197|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848198|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
848199|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848200|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848203|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848204|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848205|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848206|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848207|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848246|NCT01238848|B2|Baseline|Normal|Normal saline (sodium chloride 0.9%) + albuterol
848209|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848210|NCT01238861|O1|Outcome|Placebo|Participants received two placebo injections subcutaneously.
848211|NCT01238861|O4|Outcome|Benralizumab (100 mg)|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848212|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848213|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848214|NCT01238861|O1|Outcome|Placebo|EOS+ and EOS- participants received two placebo injections subcutaneously.
848215|NCT01238861|O6|Outcome|EOS- Benralizumab, 100 mg|EOS- participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848216|NCT01238861|O5|Outcome|EOS- Placebo|EOS- (defined as ELEN Index negative and FeNO <50 ppb) participants received matching placebo subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848217|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848218|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848219|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848220|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
848221|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848222|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848223|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848224|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
848225|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848226|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848227|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848228|NCT01238861|O3|Outcome|Benralizumab, 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
848229|NCT01238861|O2|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848230|NCT01238861|O1|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848231|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848232|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848233|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848234|NCT01238861|O1|Outcome|EOS+ Placebo|EOS+ participants received two placebo injections subcutaneously.
848235|NCT01238861|O4|Outcome|EOS+ Benralizumab, 100 mg|EOS+ participants received benralizumab 50 mg as two subcutaneous injections every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848236|NCT01238861|O3|Outcome|EOS+ Benralizumab, 20 mg|EOS+ participants received benralizumab 20 mg subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848237|NCT01238861|O2|Outcome|EOS+ Benralizumab, 2 mg|EOS+ participants received benralizumab 2 milligram (mg) subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848238|NCT01238861|O1|Outcome|Eosinophilic Phenotype (EOS+) Placebo|EOS+ (defined as ELEN Index [proprietary mathematical algorithm to predict sputum eosinophil’s greater than or equal to 2 percent] positive and/or FeNO [fraction of exhaled nitric oxide] greater than or equal to [>=] 50 parts per billion [ppb]) participants received matching placebo subcutaneous injection every 4 weeks for first 3 doses and then every 8 weeks for next 4 doses up to Week 40.
848239|NCT01238861|E6|Reported Event|EOS NEG Benralizumab 100 mg|EOS- participants received two benralizumab 50 mg injections subcutaneously.
848240|NCT01238861|E5|Reported Event|EOS NEG Placebo|EOS- participants received two placebo injections subcutaneously.
848241|NCT01238861|E4|Reported Event|EOS POS Benralizumab 100 mg|EOS+ participants received two benralizumab 50 mg injections subcutaneously.
848242|NCT01238861|E3|Reported Event|EOS POS Benralizumab 20 mg|EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
848243|NCT01238861|E2|Reported Event|EOS POS Benralizumab 2 mg|EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
848244|NCT01238861|E1|Reported Event|EOS POS Placebo|EOS+ participants received two placebo injections subcutaneously.
848245|NCT01238848|B3|Baseline|Total|Total of all reporting groups
848250|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
848251|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
848252|NCT01238848|O2|Outcome|Normal|Normal saline (sodium chloride 0.9%) + albuterol
848253|NCT01238848|O1|Outcome|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
848254|NCT01238848|E2|Reported Event|Normal|Normal saline (sodium chloride 0.9%) + albuterol
848255|NCT01238848|E1|Reported Event|Hypertonic|Hypertonic saline (sodium chloride 0.3%) + albuterol
848256|NCT01238822|B1|Baseline|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
848257|NCT01238822|P1|Participant Flow|All Participants|All participants received 3 weekly doses of methylphenidate at a low dose (18 mg), medium dosage (27 mg or 36 mg depending on weight) and a high dosage (52 mg or 36 mg depending on weight) and another week of placebo. Patients took each dosage for 1 week and parents and teachers rated their behavior at the end of each week.
848258|NCT01238822|O4|Outcome|High Dosage|54 mg methylphenidate if >25 kg; 36 mg methylphenidate if < 25 kg.
848259|NCT01238822|O3|Outcome|Medium Dosage|36 mg methylphenidate if >25 kg; 27 mg methylphenidate if < 25 kg.
848260|NCT01238822|O2|Outcome|Low Dosage|18 mg methylphenidate
848261|NCT01238822|O1|Outcome|Placebo|placebo
848262|NCT01238822|E4|Reported Event|High Dosage|54 mg methylphenidate
848263|NCT01238822|E3|Reported Event|Medium Dosage|Medium Dosage: 36 mg methylphenidate
848264|NCT01238822|E2|Reported Event|Low Dosage|Low dose: 18 mg methylphenidate
848265|NCT01238822|E1|Reported Event|Placebo|
848266|NCT01238640|B1|Baseline|Overall Study|
848267|NCT01238640|P1|Participant Flow|Overall Study|
848268|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
848269|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
848270|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
848271|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
848272|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
848273|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
848274|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
848275|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
848276|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
848277|NCT01238640|O3|Outcome|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
848278|NCT01238640|O2|Outcome|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
848279|NCT01238640|O1|Outcome|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
848280|NCT01238640|E3|Reported Event|Nicorette Microtab 2 mg|A comparative 2 mg marketed nicotine product called Nicorette Microtab
848281|NCT01238640|E2|Reported Event|STE 2 mg|"An experimental 2 mg nicotine product coded STE"
848282|NCT01238640|E1|Reported Event|STD 2 mg|"An experimental 2 mg nicotine product coded STD"
848283|NCT01238575|B3|Baseline|Total|Total of all reporting groups
848284|NCT01238575|B2|Baseline|Inactive Placebo|placebo: Administered for up to 8 weeks.
848285|NCT01238575|B1|Baseline|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848286|NCT01238575|P2|Participant Flow|Inactive Placebo|placebo: Administered for up to 8 weeks.
848287|NCT01238575|P1|Participant Flow|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848288|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848289|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848290|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848291|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848292|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848293|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848294|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848295|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848297|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848298|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848299|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848300|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848301|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848302|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848303|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848304|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848305|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848306|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848307|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848308|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848309|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848310|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848311|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848312|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848313|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848314|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848315|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848316|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848317|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848318|NCT01238575|O2|Outcome|Inactive Placebo|placebo: Administered for up to 8 weeks.
848319|NCT01238575|O1|Outcome|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848320|NCT01238575|E2|Reported Event|Inactive Placebo|placebo: Administered for up to 8 weeks.
848321|NCT01238575|E1|Reported Event|Extended-release Guanfacine|extended-release guanfacine: 1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
848322|NCT01238471|B3|Baseline|Total|Total of all reporting groups
848323|NCT01238471|B2|Baseline|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
848324|NCT01238471|B1|Baseline|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
848325|NCT01238471|P2|Participant Flow|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
848326|NCT01238471|P1|Participant Flow|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
848327|NCT01238471|O2|Outcome|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
848328|NCT01238471|O1|Outcome|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
848329|NCT01238471|E2|Reported Event|Oral Sucrose 5%|"Placebo: Oral sucrose 5% for premature infants allocated to control arm by randomization~sucrose 5%: 2 ml per Kg per day divided in 3 doses for 2-4 weeks"
848330|NCT01238471|E1|Reported Event|Propranolol|"Oral propranolol for premature infants allocated to this arm by randomization~propranolol: 2 mg per kg per day divided in 3 doses for 2-4 weeks"
848331|NCT01238341|B1|Baseline|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
848332|NCT01238341|P1|Participant Flow|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
848333|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
848334|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
848335|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
848336|NCT01238341|O1|Outcome|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
848337|NCT01238341|E1|Reported Event|Altered Gastric Anatomy|Patients with altered gastric anatomy that needed an Endoscopic Retrograde Cholangiopancreatography (ERCP) for endoscopic therapy of pancreatobiliary disease underwent ERCP with spiral overtube assisted enteroscopy.
848359|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848338|NCT01238211|B1|Baseline|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
848363|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848364|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848393|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848339|NCT01238211|P1|Participant Flow|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
848340|NCT01238211|O1|Outcome|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|"INDUCTION THERAPY: daunorubicin hydrochloride IV (60 mg/m^2)on days 1-3, cytarabine IV (200 mg/m^2) continuously over 168 hours on days 1-7, and dasatinib PO (100 mg) once daily on days 8-21. Patients achieving a response go to consolidation therapy, and patients not achieving a receive a second course of induction therapy.~CONSOLIDATION THERAPY: high-dose cytarabine IV (patients < Age 60: 3000 mg/m^2, Age >= 1000 mg/m^2)over 3 hours on days 1, 3, and 5, and dasatinib PO (100 mg) once daily on days 6-26. Treatment repeats every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients in complete remission receive continuation therapy.~CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse."
848341|NCT01238211|E1|Reported Event|Treatment (Daunorubicin Hydrochloride, Cytarabine, Dasatinib)|CONTINUATION THERAPY: dasatinib PO (100 mg) once daily for 12 months or relapse.
848342|NCT01237613|B1|Baseline|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848343|NCT01237613|P1|Participant Flow|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848344|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848345|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848346|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848347|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848348|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patientschronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848349|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848350|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848351|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848352|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848353|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848354|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848355|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848356|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848357|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848358|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848360|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848361|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848362|NCT01237613|O1|Outcome|Open|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848365|NCT01237613|E1|Reported Event|Artelon|"This was an open, prospective study with an anticipated enrollment of 10 patients with chronic or repeat Achilles tendon rupture undergoing surgical repair augmented with Artelon® Tissue Reinforcement.~Artelon: Artelon Tissue Reinforcement"
848366|NCT01237353|B1|Baseline|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
848367|NCT01237353|P1|Participant Flow|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
848368|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
848369|NCT01237353|O1|Outcome|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
848370|NCT01237353|E1|Reported Event|Betaine Hydrochloride and Rabeprazole|"betaine hydrochloride : betaine hydrochloride 1500mg po x 1 on day 5~Rabeprazole : rabeprazole po daily x 5 days"
848371|NCT01237340|B1|Baseline|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848372|NCT01237340|P1|Participant Flow|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848373|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848374|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848375|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848376|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848377|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848378|NCT01237340|O2|Outcome|GH Treatment-Experienced|Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Growth hormone (GH) Treatment-experienced participants were those who had undergone treatment with the freeze-dried formulation of Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848379|NCT01237340|O1|Outcome|GH Treatment-Naive|Growth hormone (GH) Treatment-Naive participants were those who did not receive any prior treatment with Saizen® before initiation of the trial. Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848380|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848381|NCT01237340|O1|Outcome|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848382|NCT01237340|E1|Reported Event|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
848383|NCT01237327|B3|Baseline|Total|Total of all reporting groups
848384|NCT01237327|B2|Baseline|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848385|NCT01237327|B1|Baseline|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848386|NCT01237327|P2|Participant Flow|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848387|NCT01237327|P1|Participant Flow|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848388|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848389|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848390|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848391|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848392|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848394|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848395|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848396|NCT01237327|O2|Outcome|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848397|NCT01237327|O1|Outcome|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848398|NCT01237327|E2|Reported Event|Megestrol Acetate|Megestrol acetate 160 mg tablet taken once daily
848399|NCT01237327|E1|Reported Event|Exemestane|Exemestane 25 milligram (mg) oral tablet taken once daily
848400|NCT01237301|B3|Baseline|Total|Total of all reporting groups
848401|NCT01237301|B2|Baseline|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848402|NCT01237301|B1|Baseline|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848403|NCT01237301|P2|Participant Flow|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848404|NCT01237301|P1|Participant Flow|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848405|NCT01237301|O2|Outcome|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848406|NCT01237301|O1|Outcome|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848407|NCT01237301|E2|Reported Event|SMBG Group|"Use SMBG 4 to 7 times a day for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848408|NCT01237301|E1|Reported Event|CGM Group|"Wear an unblinded CGM for 16 weeks.~Continuous Glucose Monitoring (CGM) : Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes."
848409|NCT01237223|B7|Baseline|Total|Total of all reporting groups
848410|NCT01237223|B6|Baseline|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848411|NCT01237223|B5|Baseline|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
848412|NCT01237223|B4|Baseline|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848413|NCT01237223|B3|Baseline|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848414|NCT01237223|B2|Baseline|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848415|NCT01237223|B1|Baseline|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
848473|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
848474|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
848475|NCT01237080|O2|Outcome|GlideScope|50 persons beeing intubated using the GlideScope.
850862|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
848416|NCT01237223|P6|Participant Flow|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848417|NCT01237223|P5|Participant Flow|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
848418|NCT01237223|P4|Participant Flow|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848597|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848419|NCT01237223|P3|Participant Flow|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848420|NCT01237223|P2|Participant Flow|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848421|NCT01237223|P1|Participant Flow|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in (4 weeks) and double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
848422|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848423|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
848424|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848425|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848426|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848427|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
848428|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848429|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
848430|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848431|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848432|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848476|NCT01237080|O1|Outcome|Fastrach|50 persons beeing intubated using the Fastrach.
848433|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
848434|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848435|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
851446|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
848436|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848437|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848438|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848439|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
848440|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848441|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
848442|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848443|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848444|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848445|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind period.
848446|NCT01237223|O6|Outcome|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848447|NCT01237223|O5|Outcome|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
848448|NCT01237223|O4|Outcome|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848449|NCT01237223|O3|Outcome|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848477|NCT01237080|E2|Reported Event|GlideScope|50 persons beeing intubated using the GlideScope.
848478|NCT01237080|E1|Reported Event|Fastrach|50 persons beeing intubated using the Fastrach.
848450|NCT01237223|O2|Outcome|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848451|NCT01237223|O1|Outcome|Placebo|In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. Patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily for 8 weeks of double blind treatment period.
848452|NCT01237223|E7|Reported Event|Placebo (Single-Blind run-in Period)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In single blind run-in period (4 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
848453|NCT01237223|E6|Reported Event|Aliskiren/Amlodipine 150/5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848454|NCT01237223|E5|Reported Event|Aliskiren/Amlodipine 150/2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received aliskiren/amlodipine 150/2.5 mg tablet o.d. + placebo of two amlodipine 2.5 mg capsules o.d., aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. for 8 weeks of double blind period."
848455|NCT01237223|E4|Reported Event|Amlodipine 5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received amlodipine 5 mg (two amlodipine 2.5 mg capsules o.d.)+ placebo of aliskiren 150 mg tablet o.d., aliskiren/amlodipine 150/5 mg tablet o.d. , aliskiren/amlodipine 150/2.5 mg tablet o.d. for 8 weeks of double blind period."
848456|NCT01237223|E3|Reported Event|Amlodipine 2.5 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Amlodipine 2.5 mg capsule once daily (o.d)+ placebo of amlodipine 2.5 mg capsule o.d., Aliskiren 150 mg o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848457|NCT01237223|E2|Reported Event|Aliskiren 150 mg|"In order to adequately blind the study, patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study.~Patients received Aliskiren 150 mg tablet once daily (o.d)+ placebo of two amlodipine 2.5 mg capsule o.d., aliskiren/amlodipine 150/5 mg tablet o.d , aliskiren/amlodipine 150/2.5 mg tablet o.d for 8 weeks of double blind period."
848458|NCT01237223|E1|Reported Event|Placebo (Double Blind)|In order to adequately blind the study,patients were required to take a total of 3 tablets and 2 capsules of study medication throughout the study. In double blind treatment period (8 weeks), patients were received matching placebo of aliskiren/amlodipine 150/5 mg tablet, aliskiren/amlodipine 150/2.5 mg tablet, aliskiren 150 mg tablet and two amlodipine 2.5 mg capsules once daily.
848459|NCT01237197|B3|Baseline|Total|Total of all reporting groups
848460|NCT01237197|B2|Baseline|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
848461|NCT01237197|B1|Baseline|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
848462|NCT01237197|P2|Participant Flow|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
848463|NCT01237197|P1|Participant Flow|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open label Exenatide : Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study."
848464|NCT01237197|O2|Outcome|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
848465|NCT01237197|O1|Outcome|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
848466|NCT01237197|E2|Reported Event|Placebo Injection|"Placebo injection twice a day for three months; Exenatide open label 5mcg twice a day for one month and up-titrated to 10mcg twice a day for remaining two months of study.~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
848467|NCT01237197|E1|Reported Event|Exenatide|"Exenatide 5 micrograms (mcg): administered with injection twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study (5 months)~Open Label Exenatide : Exenatide 5 micrograms (mcg) twice per day for one month; up-titrated to 10 mcg twice per day for remainder of study."
848468|NCT01237080|B3|Baseline|Total|Total of all reporting groups
848469|NCT01237080|B2|Baseline|GlideScope|50 persons beeing intubated using the GlideScope.
848470|NCT01237080|B1|Baseline|Fastrach|50 persons beeing intubated using the Fastrach.
848471|NCT01237080|P2|Participant Flow|GlideScope|50 persons beeing intubated using the GlideScope.
848472|NCT01237080|P1|Participant Flow|Fastrach|50 persons beeing intubated using the Fastrach.
850879|NCT01229228|P1|Participant Flow|Naproxen Test (Lower Dose)|
848479|NCT01237054|B1|Baseline|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
848598|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
848884|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
848480|NCT01237054|P1|Participant Flow|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
848481|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
848482|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
848483|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
848484|NCT01237054|O3|Outcome|MM (Multiple Myeloma)|Multiple myeloma is a plasma cell neoplasm.
848485|NCT01237054|O2|Outcome|SMM (Smoldering Multiple Myeloma)|Smoldering multiple myeloma (SMM)is a premalignant plasma cell proliferative disorder.
848486|NCT01237054|O1|Outcome|MGUS (Monoclonal Gammopathy of Undetermined Significance)|MGUS (Monoclonal gammopathy of undetermined significance) is a premalignant plasma cell proliferative disorder.
848487|NCT01237054|E1|Reported Event|Imaging in MGUS, SMM, and MM|"Participants will have three imaging studies on separate days: a standard positron emission tomography/computed tomography scan (18-FDG PET/CT), a PET/CT scan with an experimental sodium fluoride-based drug (18-NaF PET/CT), and magnetic resonance imaging (DCE-MRI).~18-NaF PET: The patient will patient will receive 5mCi of F-18 NaF IV bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection. DCE-MRI: An FDA approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).18-FDG PET/CT: The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline flush over a period of ~20 sec."
848488|NCT01236573|B12|Baseline|Total|Total of all reporting groups
848489|NCT01236573|B11|Baseline|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848490|NCT01236573|B10|Baseline|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848491|NCT01236573|B9|Baseline|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848492|NCT01236573|B8|Baseline|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848493|NCT01236573|B7|Baseline|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848575|NCT01236378|E1|Reported Event|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848576|NCT01236365|B3|Baseline|Total|Total of all reporting groups
848494|NCT01236573|B6|Baseline|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848594|NCT01236339|P2|Participant Flow|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)"
848595|NCT01236339|P1|Participant Flow|TIPS|TIPS with GORE® VIATORR® TIPS Endoprosthesis
848495|NCT01236573|B5|Baseline|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848496|NCT01236573|B4|Baseline|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848497|NCT01236573|B3|Baseline|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848498|NCT01236573|B2|Baseline|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848499|NCT01236573|B1|Baseline|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848500|NCT01236573|P11|Participant Flow|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848501|NCT01236573|P10|Participant Flow|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848502|NCT01236573|P9|Participant Flow|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848503|NCT01236573|P8|Participant Flow|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848504|NCT01236573|P7|Participant Flow|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848505|NCT01236573|P6|Participant Flow|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848577|NCT01236365|B2|Baseline|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
848578|NCT01236365|B1|Baseline|Atorvastatin|Atorvastatin: 10 or 20 mg daily
850880|NCT01229228|O5|Outcome|Placebo|
848506|NCT01236573|P5|Participant Flow|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848507|NCT01236573|P4|Participant Flow|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848508|NCT01236573|P3|Participant Flow|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848509|NCT01236573|P2|Participant Flow|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848510|NCT01236573|P1|Participant Flow|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848511|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848512|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848513|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848514|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848515|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848516|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848517|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848579|NCT01236365|P2|Participant Flow|Placebo|Placebo: 10 or 20 mg daily
848580|NCT01236365|P1|Participant Flow|Atorvastatin|Atorvastatin: 10 or 20 mg daily
848581|NCT01236365|O4|Outcome|Placebo hsCRP at 6 Months|
848518|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848519|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848520|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848521|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848522|NCT01236573|O11|Outcome|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848523|NCT01236573|O10|Outcome|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848524|NCT01236573|O9|Outcome|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848525|NCT01236573|O8|Outcome|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848526|NCT01236573|O7|Outcome|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848527|NCT01236573|O6|Outcome|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848528|NCT01236573|O5|Outcome|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848529|NCT01236573|O4|Outcome|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848582|NCT01236365|O3|Outcome|Placebo hsCRP at Randomization|
848583|NCT01236365|O2|Outcome|Atorvastatin hsCRP at 6 Months|
848584|NCT01236365|O1|Outcome|Atorvastatin hsCRP at Randomization|
848530|NCT01236573|O3|Outcome|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848531|NCT01236573|O2|Outcome|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848532|NCT01236573|O1|Outcome|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848533|NCT01236573|O1|Outcome|All Phase I Participants|All phase I participants who received at least one dose intravenously of CD8 + TIL expressing IL-12 in Groups 1-4, and Bulk TIL expressing IL-12 in Groups 5-10 (i.e., CD8 + TIL expressing IL-12 1x10^6, CD8 + TIL expressing IL-12 3x10^6, CD8 + TIL expressing IL-12 3x10^7, CD8 + TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^7, Bulk TIL expressing IL-12 3x10^7, Bulk TIL expressing IL-12 1x10^8, Bulk TIL expressing IL-12 3x10^8, Bulk TIL expressing IL-12 1x10^9, and Bulk TIL expressing IL-12 3x10^9) respectively.
848534|NCT01236573|E11|Reported Event|Group 11 - Bulk TIL Expressing MTD 1x10^9 (Phase 2)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848535|NCT01236573|E10|Reported Event|Group 10 - Bulk TIL Expressing IL12 3x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848536|NCT01236573|E9|Reported Event|Group 9 - Bulk TIL Expressing IL-12 1x10^9 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848537|NCT01236573|E8|Reported Event|Group 8 - Bulk TIL Expressing IL-12 3x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848538|NCT01236573|E7|Reported Event|Group 7- Bulk TIL Expressing IL-12 1x10^8 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848539|NCT01236573|E6|Reported Event|Group 6 - Bulk TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848540|NCT01236573|E5|Reported Event|Group 5 - Bulk TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848541|NCT01236573|E4|Reported Event|Group 4 - CD8 + TIL Expressing IL-12 3x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848585|NCT01236365|O4|Outcome|Placebo LDL-C at 6 Months|
848586|NCT01236365|O3|Outcome|Placebo LDL-C at Randomization|
848587|NCT01236365|O2|Outcome|Atorvastatin LDL-C at 6 Months|
848542|NCT01236573|E3|Reported Event|Group 3 - CD8 + TIL Expressing IL-12 1x10^7 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848543|NCT01236573|E2|Reported Event|Group 2 - CD8 + TIL Expressing IL-12 3x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848544|NCT01236573|E1|Reported Event|Group 1 - CD8 + TIL Expressing IL-12 1x10^6 (Phase 1)|"Patients will receive a nonmyeloablative but lymphocyte depleting preparative regimen consisting of cyclophosphamide and fludarabine followed by intravenous infusion of IL-12 gene-transduced TIL.~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.~IL-12 transduced TIL: On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes."
848545|NCT01236534|B3|Baseline|Total|Total of all reporting groups
848546|NCT01236534|B2|Baseline|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
848547|NCT01236534|B1|Baseline|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
848548|NCT01236534|P2|Participant Flow|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
848549|NCT01236534|P1|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
848550|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
848551|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
848552|NCT01236534|O2|Outcome|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
848553|NCT01236534|O1|Outcome|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
848554|NCT01236534|E2|Reported Event|Sugar Pill|Placebo : matching placebo twice daily for 21 days.
848555|NCT01236534|E1|Reported Event|Lubiprostone|Lubiprostone : 24 mcg twice daily for 21 days.
848556|NCT01236391|B1|Baseline|PCI-32765|PCI-32765: 560 mg daily
848557|NCT01236391|P1|Participant Flow|PCI-32765|Participants received 560 mg daily
848558|NCT01236391|O1|Outcome|EORTC QLQ-C30|Participants received PCI-32765 560 mg daily and completed the EORTC QLQ-C30 questionnaire at Pre-Dose and at Cycle 5
848559|NCT01236391|O2|Outcome|PCI-45227 (Metabolite)- Day 8|PCI-32765: 560 mg daily
848560|NCT01236391|O1|Outcome|PCI-32765 - Day 8|PCI-32765: 560 mg daily
848561|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
848562|NCT01236391|O1|Outcome|PCI-32765|PCI-32765: 560 mg daily
848563|NCT01236391|E1|Reported Event|PCI-32765|PCI-32765: 560 mg daily
848564|NCT01236378|B1|Baseline|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848565|NCT01236378|P1|Participant Flow|Sirolimus|Sirolimus, 1 milligram (mg) tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last pharmacokinetic (PK) sample collection.
848566|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848567|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848568|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848569|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848570|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848571|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848572|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848573|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848574|NCT01236378|O1|Outcome|Sirolimus|Sirolimus, 1 mg tablet formulation; total daily dosage could have varied from participant to participant, dosage must have been stable for at least 2 weeks prior to screening and continued with no change until completion of the last PK sample collection.
848588|NCT01236365|O1|Outcome|Atorvastatin LDL-C at Randomization|
848589|NCT01236365|E2|Reported Event|Placebo|Atorvastatin Placebo: 10 or 20 mg daily
848592|NCT01236339|B2|Baseline|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
848593|NCT01236339|B1|Baseline|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848596|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
848599|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848600|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
848601|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848602|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
848603|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848604|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
848605|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848606|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
848607|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848608|NCT01236339|O2|Outcome|LVP (Large Volume Paracentesis)|LVP: Large Volume Paracentesis
848609|NCT01236339|O1|Outcome|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848610|NCT01236339|E2|Reported Event|LVP (Large Volume Paracentesis)|"Large Volume Paracentesis~*A subject may be crossed-over from large volume paracentesis to TIPS with GORE® VIATORR® TIPS Endoprosthesis if the subject has completed their six month study visit and has met the criteria for cross-over (LVP failure)."
848611|NCT01236339|E1|Reported Event|TIPS|"TIPS with GORE® VIATORR® TIPS Endoprosthesis >~> TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis: TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis"
848612|NCT01236326|B3|Baseline|Total|Total of all reporting groups
848613|NCT01236326|B2|Baseline|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848614|NCT01236326|B1|Baseline|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848615|NCT01236326|P2|Participant Flow|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848616|NCT01236326|P1|Participant Flow|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848617|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848618|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848619|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848620|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848621|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848622|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848623|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848624|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848625|NCT01236326|O2|Outcome|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848626|NCT01236326|O1|Outcome|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848627|NCT01236326|E2|Reported Event|Conventional LDN|Conventional laparoscopic donor nephrectomy: Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
848628|NCT01236326|E1|Reported Event|LESS-DN|Laparoendoscopic single site donor nephrectomy: Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
848629|NCT01236300|B1|Baseline|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
849632|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
848630|NCT01236300|P1|Participant Flow|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
848631|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
848632|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
848633|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
848634|NCT01236300|O1|Outcome|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
849715|NCT01233232|B1|Baseline|Placebo|4 x placebo capsules, twice daily (bid)
848635|NCT01236300|O1|Outcome|nCLE System (Stage 2)|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL). Stage 2 assessed whether the specific criteria defiend in Stage 1 could identify pancreatic cystic neoplasms (PCN).
848636|NCT01236300|E1|Reported Event|nCLE System|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system was performed in patients with Pancreatic cystic lesions (PCL).
848637|NCT01236196|B3|Baseline|Total|Total of all reporting groups
848638|NCT01236196|B2|Baseline|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
848639|NCT01236196|B1|Baseline|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
848640|NCT01236196|P2|Participant Flow|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
848641|NCT01236196|P1|Participant Flow|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
848642|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
848643|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
848644|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
848645|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
848646|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
848647|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
848648|NCT01236196|O2|Outcome|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
848649|NCT01236196|O1|Outcome|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
848650|NCT01236196|E2|Reported Event|Arm 2 - Telephone Education|"Telephone pain education~Telephone pain education: Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period)."
848651|NCT01236196|E1|Reported Event|Arm 1 - Telephone CBT|"Telephone cognitive behavior therapy for pain management~Telephone cognitive behavior therapy: Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period)."
848652|NCT01236170|B1|Baseline|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
848653|NCT01236170|P1|Participant Flow|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
848654|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
848655|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
848656|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
848657|NCT01236170|O1|Outcome|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
848658|NCT01236170|E1|Reported Event|Group 1|Veterans with spinal cord injury or amputated limbs who use a wheelchair as their primary source of mobility
848659|NCT01236118|B4|Baseline|Total|Total of all reporting groups
848660|NCT01236118|B3|Baseline|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 Q2W subcutaneous injection for the first 3 doses then Q4W until Week 44.
848680|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
849768|NCT01233232|E2|Reported Event|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
848661|NCT01236118|B2|Baseline|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and then Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
848662|NCT01236118|B1|Baseline|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
848663|NCT01236118|P3|Participant Flow|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
848664|NCT01236118|P2|Participant Flow|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
848665|NCT01236118|P1|Participant Flow|30 mg LY2439821|Included participants from 30 milligrams (mg) group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection once every week (Q1W) for the first 3 doses and once every 2 weeks (Q2W) until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection once every 4 weeks (Q4W) until Week 44.
848666|NCT01236118|O3|Outcome|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
848667|NCT01236118|O2|Outcome|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 Q1W subcutaneous injection for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
848668|NCT01236118|O1|Outcome|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
848669|NCT01236118|E3|Reported Event|160 mg LY2439821|Included participants from either 30 mg or 80 mg group and started after the safety of 180 mg dose was confirmed in the Study I1F-JE-RHAL (NCT01253265). Participants received 160 mg LY2439821 subcutaneous injection Q2W for the first 3 doses then Q4W until Week 44.
848670|NCT01236118|E2|Reported Event|80 mg LY2439821|Included participants from 80 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 80 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
848671|NCT01236118|E1|Reported Event|30 mg LY2439821|Included participants from 30 mg group of Study I1F-JE-RHAL (NCT01253265). Participants received 30 mg LY2439821 subcutaneous injection Q1W for the first 3 doses and Q2W until the safety data was confirmed to increase the dose. Dose was increased to 160 mg once safety of 180 mg dose was confirmed in Study I1F-JE-RHAL (NCT01253265). Participants then received 160 mg LY2439821 subcutaneous injection Q4W until Week 44.
848672|NCT01236105|B1|Baseline|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
848673|NCT01236105|P1|Participant Flow|LY2624803|"Participants received each of the following 3 study treatments:~LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.~LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.~LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast."
848674|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
848675|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
848676|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
848677|NCT01236105|O3|Outcome|LY2624803 Alone Evening Dosing|Participants received 6 mg LY2624803 alone po QD at approximately 2200 hours following a 4-hour fast.
848678|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
848679|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
848681|NCT01236105|O2|Outcome|LY2624803 Morning Dosing Plus Activated Charcoal|Participants received 6 mg LY2624803 po QD at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
848682|NCT01236105|O1|Outcome|LY2624803 Alone Morning Dosing|Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once (QD) at approximately 0800 hours following an overnight fast.
848683|NCT01236105|E3|Reported Event|LY2624803 Evening Dosing|LY2624803 Alone Evening Dosing: Participants received 6 mg LY2624803 alone po once at approximately 2200 hours following a 4-hour fast.
848684|NCT01236105|E2|Reported Event|LY2624803 Morning Dosing + Activated Charcoal|LY2624803 Morning Dosing Plus Activated Charcoal: Participants received 6 mg LY2624803 po once at approximately 0800 hours following an overnight fast, followed 1 hour later by a single po dose of 1 gram per kilogram (g/kg) body weight of activated charcoal, mixed with caffeine-free diet cola.
849716|NCT01233232|P3|Participant Flow|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
848685|NCT01236105|E1|Reported Event|LY2624803 Morning Dosing|LY2624803 Alone Morning Dosing: Participants received 6 milligrams (mg) LY2624803 alone, orally (po) once at approximately 0800 hours following an overnight fast.
848686|NCT01236053|B23|Baseline|Total|Total of all reporting groups
848687|NCT01236053|B22|Baseline|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848688|NCT01236053|B21|Baseline|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848689|NCT01236053|B20|Baseline|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848690|NCT01236053|B19|Baseline|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848691|NCT01236053|B18|Baseline|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848692|NCT01236053|B17|Baseline|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848693|NCT01236053|B16|Baseline|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848694|NCT01236053|B15|Baseline|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848695|NCT01236053|B14|Baseline|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848696|NCT01236053|B13|Baseline|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848743|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848697|NCT01236053|B12|Baseline|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848698|NCT01236053|B11|Baseline|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848699|NCT01236053|B10|Baseline|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848700|NCT01236053|B9|Baseline|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848701|NCT01236053|B8|Baseline|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848702|NCT01236053|B7|Baseline|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848703|NCT01236053|B6|Baseline|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848704|NCT01236053|B5|Baseline|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848705|NCT01236053|B4|Baseline|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848706|NCT01236053|B3|Baseline|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848707|NCT01236053|B2|Baseline|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848708|NCT01236053|B1|Baseline|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848709|NCT01236053|P22|Participant Flow|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
849769|NCT01233232|E1|Reported Event|Placebo|4 x placebo capsules, twice daily (bid)
848710|NCT01236053|P21|Participant Flow|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848711|NCT01236053|P20|Participant Flow|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848712|NCT01236053|P19|Participant Flow|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848713|NCT01236053|P18|Participant Flow|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848714|NCT01236053|P17|Participant Flow|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848715|NCT01236053|P16|Participant Flow|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848716|NCT01236053|P15|Participant Flow|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848717|NCT01236053|P14|Participant Flow|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848718|NCT01236053|P13|Participant Flow|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848719|NCT01236053|P12|Participant Flow|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848720|NCT01236053|P11|Participant Flow|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848721|NCT01236053|P10|Participant Flow|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848722|NCT01236053|P9|Participant Flow|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848723|NCT01236053|P8|Participant Flow|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848724|NCT01236053|P7|Participant Flow|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848725|NCT01236053|P6|Participant Flow|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848726|NCT01236053|P5|Participant Flow|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848727|NCT01236053|P4|Participant Flow|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848728|NCT01236053|P3|Participant Flow|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848729|NCT01236053|P2|Participant Flow|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848730|NCT01236053|P1|Participant Flow|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848731|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848732|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
848733|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848734|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
848735|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848736|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
848737|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848738|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
848739|NCT01236053|O2|Outcome|Matched Controls for Incident Renal Cancer Patients|Cancer-free control patients risk set matched with incident renal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848740|NCT01236053|O1|Outcome|Incident Renal Cancer Patients|Patients with incident renal cancer defined from READ/OXMIS codes in the years 1995-2008
848741|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848742|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
849770|NCT01233076|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
848744|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
848745|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848746|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
848747|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848748|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
848749|NCT01236053|O2|Outcome|Matched Controls for Incident Pancreatic Cancer Patients|Cancer-free control patients risk set matched with incident pancreatic cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848750|NCT01236053|O1|Outcome|Incident Pancreatic Cancer Patients|Patients with incident pancreatic cancer defined from READ/OXMIS codes in the years 1995-2008
848751|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848752|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
848753|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848754|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
848755|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848756|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
848757|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848758|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
848759|NCT01236053|O2|Outcome|Matched Controls for Incident ONS Cancer Patients|Cancer-free control patients risk set matched with incident other nervous system cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848760|NCT01236053|O1|Outcome|Incident Other Nervous System Cancer Patients|Patients with incident other nervous system cancer defined from READ/OXMIS codes in the years 1995-2008
848761|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848762|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
848763|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848764|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
848765|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848766|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
848767|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848768|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
848769|NCT01236053|O2|Outcome|Matched Controls for Incident Bladder Cancer Patients|Cancer-free control patients risk set matched with incident bladder cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848770|NCT01236053|O1|Outcome|Incident Bladder Cancer Patients|Patients with incident bladder cancer defined from READ/OXMIS codes in the years 1995-2008
848771|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848772|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
848773|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848774|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
850596|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
848775|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848776|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
848777|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848778|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
848812|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
848779|NCT01236053|O2|Outcome|Matched Controls for Incident Penile Cancer Patients|Cancer-free control patients risk set matched with incident penile cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848780|NCT01236053|O1|Outcome|Incident Penile Cancer Patients|Patients with incident penile cancer defined from READ/OXMIS codes in the years 1995-2008
848781|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848782|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
848783|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848784|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
848785|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848786|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
848787|NCT01236053|O2|Outcome|Controls|Controls
848788|NCT01236053|O1|Outcome|Cases|Cases
848789|NCT01236053|O2|Outcome|Matched Controls for Incident Breast Cancer Patients|Cancer-free control patients risk set matched with incident breast cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848790|NCT01236053|O1|Outcome|Incident Breast Cancer Patients|Patients with incident breast cancer defined from READ/OXMIS codes in the years 1995-2008
848791|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848792|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
848793|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848794|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
848795|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848796|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
848797|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848798|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
848799|NCT01236053|O2|Outcome|Matched Controls for Incident Bone/Joint Cancer Patients|Cancer-free control patients risk set matched with incident bone/joint cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848800|NCT01236053|O1|Outcome|Incident Bone/Joint Cancer Patients|Patients with incident bone/joint cancer defined from READ/OXMIS codes in the years 1995-2008
848801|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice
848802|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
848803|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848804|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
848805|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848806|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
848807|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848808|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
848809|NCT01236053|O2|Outcome|Matched Controls for Incident Lung Cancer Patients|Cancer-free control patients risk set matched with incident lung cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848810|NCT01236053|O1|Outcome|Incident Lung Cancer Patients|Patients with incident lung cancer defined from READ/OXMIS codes in the years 1995-2008
848811|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
851447|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
848813|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848814|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
848815|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848816|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
848817|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848818|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
848819|NCT01236053|O2|Outcome|Matched Controls for Incident Anal Cancer Patients|Cancer-free control patients risk set matched with incident anal cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848820|NCT01236053|O1|Outcome|Incident Anal Cancer Patients|Patients with incident anal cancer defined from READ/OXMIS codes in the years 1995-2008
848821|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848822|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
848823|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848824|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
848825|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848826|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
848827|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848828|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
848829|NCT01236053|O2|Outcome|Matched Controls for Incident Stomach Cancer Patients|Cancer-free control patients risk set matched with incident stomach cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848830|NCT01236053|O1|Outcome|Incident Stomach Cancer Patients|Patients with incident stomach cancer defined from READ/OXMIS codes in the years 1995-2008
848831|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848832|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
848833|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848834|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
848835|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848836|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
848837|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848838|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
848839|NCT01236053|O2|Outcome|Matched Controls for Incident All-cancer Patients|Cancer-free control patients risk set matched with incident all-cancer patients for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site
848840|NCT01236053|O1|Outcome|Incident All-cancer Patients|Patients with any type of incident cancer defined from READ/OXMIS codes in the years 1995-2008
848841|NCT01236053|E22|Reported Event|Renal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848881|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
848882|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848883|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848842|NCT01236053|E21|Reported Event|Renal Cancer: Cases|Incidence of renal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848843|NCT01236053|E20|Reported Event|Pancreatic Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848844|NCT01236053|E19|Reported Event|Pancreatic Cancer: Cases|Incidence of pancreatic cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848845|NCT01236053|E18|Reported Event|Other Nervous System Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848846|NCT01236053|E17|Reported Event|Other Nervous System Cancer: Cases|Incidence of other nervous system cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848847|NCT01236053|E16|Reported Event|Bladder Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848848|NCT01236053|E15|Reported Event|Bladder Cancer: Cases|Incidence of bladder cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848849|NCT01236053|E14|Reported Event|Penile Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848850|NCT01236053|E13|Reported Event|Penile Cancer: Cases|Incidence of penile cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848851|NCT01236053|E12|Reported Event|Breast Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848852|NCT01236053|E11|Reported Event|Breast Cancer: Cases|Incidence of breast cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848853|NCT01236053|E10|Reported Event|Bone/Joint Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848854|NCT01236053|E9|Reported Event|Bone/Joint Cancer: Cases|Incidence of bone/joint cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848855|NCT01236053|E8|Reported Event|Lung Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848856|NCT01236053|E7|Reported Event|Lung Cancer: Cases|Incidence of lung cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848857|NCT01236053|E6|Reported Event|Anal Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848858|NCT01236053|E5|Reported Event|Anal Cancer: Cases|Incidence of anal cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848859|NCT01236053|E4|Reported Event|Stomach Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848860|NCT01236053|E3|Reported Event|Stomach Cancer: Cases|Incidence of stomach cancer defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848861|NCT01236053|E2|Reported Event|All-Cancer: Controls|Cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin. Participants with a history of cancer prior to the index date were excluded as controls.
848862|NCT01236053|E1|Reported Event|All-Cancer: Cases|Incidence of all cancers defined as first time incident cancer diagnosis (READ/Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the study cohort began January 1, 1993, or at the time of GPRD registration if after January 1, 1993. Follow-up ended December 31, 2008, or earlier if the respective cancer was diagnosed or if the participant left the GPRD for any reason including death. Participants with a prior history of cancer were excluded.
848863|NCT01236001|B3|Baseline|Total|Total of all reporting groups
848864|NCT01236001|B2|Baseline|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848865|NCT01236001|B1|Baseline|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848866|NCT01236001|P2|Participant Flow|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848867|NCT01236001|P1|Participant Flow|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848868|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
848869|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848870|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848871|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
848872|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848873|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848874|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848875|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
848876|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848877|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848878|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
848879|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848880|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848885|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848886|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848887|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848888|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
848889|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848890|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848891|NCT01236001|O3|Outcome|Total Population|Patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® on/after enrollment.
848892|NCT01236001|O2|Outcome|Patients Who Started VIMPAT® Treatment on/After Enrollment|Patients who started VIMPAT® treatment on/after enrollment.
848893|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848894|NCT01236001|O1|Outcome|Patients Treated With VIMPAT® Prior to Enrollment|Patients who started VIMPAT® treatment before enrollment.
848895|NCT01236001|E1|Reported Event|Vimpat® Treatment|Reported Adverse Events is a combination of both patients who started VIMPAT® treatment before enrollment and patients who started VIMPAT® treatment on/after enrollment.
848896|NCT01235975|B3|Baseline|Total|Total of all reporting groups
848897|NCT01235975|B2|Baseline|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848898|NCT01235975|B1|Baseline|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848899|NCT01235975|P2|Participant Flow|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848900|NCT01235975|P1|Participant Flow|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848901|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848902|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848903|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848904|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848905|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848906|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848907|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848908|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848909|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848910|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848911|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848912|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848913|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848914|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848915|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848916|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848917|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
849046|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
848918|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848919|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848920|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848921|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848922|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848923|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848924|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848925|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848926|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848927|NCT01235975|O2|Outcome|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848928|NCT01235975|O1|Outcome|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848929|NCT01235975|E2|Reported Event|Mencevax Group|Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
848930|NCT01235975|E1|Reported Event|Nimenrix Group|Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
848931|NCT01235923|B3|Baseline|Total|Total of all reporting groups
848932|NCT01235923|B2|Baseline|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
848933|NCT01235923|B1|Baseline|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
848934|NCT01235923|P2|Participant Flow|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
848935|NCT01235923|P1|Participant Flow|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
848936|NCT01235923|O2|Outcome|Three Times a Week Epo|
848937|NCT01235923|O1|Outcome|Weekly Epo|
848938|NCT01235923|O2|Outcome|Three Times a Week Epo|
848939|NCT01235923|O1|Outcome|Weekly Epo|
848940|NCT01235923|E2|Reported Event|Three Times Weekly Epo|Epo 400 units/kg three times weekly given subcutaneously for 4 weeks
848941|NCT01235923|E1|Reported Event|Weekly Epo|Epo 1,200 units/kg given once a week subcutaneously for 4 weeks
848942|NCT01235910|B1|Baseline|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
848943|NCT01235910|P1|Participant Flow|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
848944|NCT01235910|O1|Outcome|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
848945|NCT01235910|E1|Reported Event|Aliskiren|"Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows~Aliskiren: Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows"
848946|NCT01235897|B1|Baseline|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
848947|NCT01235897|P1|Participant Flow|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
848948|NCT01235897|O1|Outcome|MK-2206|MK-2206 given orally at a dose of 135 mg weekly + Trastuzumab 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg + Paclitaxel 80 mg/m2 weekly
848949|NCT01235897|O1|Outcome|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
848950|NCT01235897|E1|Reported Event|MK-2206|MK-2206 : MK-2206 given orally at a dose of 135 mg weekly Trastuzumab : 2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab Paclitaxel : 80 mg/m2 weekly - paclitaxel
848951|NCT01235741|B4|Baseline|Total|Total of all reporting groups
848952|NCT01235741|B3|Baseline|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848953|NCT01235741|B2|Baseline|Placebo|Self administered subcutaneous (SC ) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
848990|NCT01235728|P2|Participant Flow|Treatment Sequence 2|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
848954|NCT01235741|B1|Baseline|Non-Randomized Lead-in LCD|6 Week Lead-in with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to study drug in the Randomization period.
848955|NCT01235741|P3|Participant Flow|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 micrograms (µg) + metreleptin 5.0 milligrams (mg) BID for 16 weeks
848956|NCT01235741|P2|Participant Flow|Placebo|Self administered subcutaneous (SC) injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) twice a day (BID) for 16 weeks.
848957|NCT01235741|P1|Participant Flow|Low Calorie Diet Only|6 Week Lead-in Period with low calorie diet (LCD); in the last week of the 6 week LCD, self administered subcutaneous (SC) injections of placebo once a day (QD) was initiated and then followed by randomization to either study drug or placebo in the Randomization period.
848958|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848959|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
848960|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848961|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
848962|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848963|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks
848964|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848965|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
848966|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848967|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
848968|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848969|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
848970|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848971|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
848972|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848973|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848974|NCT01235741|O1|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848975|NCT01235741|O4|Outcome|Post Treatment Pramlintide + Metreleptin Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
848976|NCT01235741|O3|Outcome|Post Treatment Placebo Arm|From date after the date of last dose (imputed if not available) of randomized study medication up to 6 Months post treatment.
848977|NCT01235741|O2|Outcome|On Treatment Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848978|NCT01235741|O1|Outcome|On Treatment Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
848979|NCT01235741|O2|Outcome|Pramlintide + Metreleptin|Self administered SC injection of pramlintide 360 µg + metreleptin 5.0 mg BID for 16 weeks
848980|NCT01235741|O1|Outcome|Placebo|Self administered SC injection of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) BID for 16 weeks.
848981|NCT01235741|E2|Reported Event|Pramlintide + Metreleptin|Self administered subcutaneous injection once a day (QD) of pramlintide 360 micrograms (µg) plus metreleptin 5.0 milligrams (mg ) for 1 week followed by twice a week (BID) dosing for 15 weeks (Total of 16 Weeks treatment).
848982|NCT01235741|E1|Reported Event|Placebo-P + Placebo-M|Self administered subcutaneous injection once a day (QD) of placebo matched to pramlintide (Placebo-P) plus placebo matched to metreleptin (Placebo-M) for 1 week followed by BID dosing for 15 weeks (16 weeks total).
848983|NCT01235728|B1|Baseline|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
848984|NCT01235728|P8|Participant Flow|Treatment Sequence 8|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and calcitriol on upper lesion C and MK-0873 on upper lesion D.
848985|NCT01235728|P7|Participant Flow|Treatment Sequence 7|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
848986|NCT01235728|P6|Participant Flow|Treatment Sequence 6|Participants were randomized to receive vehicle on lower lesion A and MK-0873 on lower lesion B, and MK-0873 on upper lesion C and calcitriol on upper lesion D.
848987|NCT01235728|P5|Participant Flow|Treatment Sequence 5|Participants were randomized to receive vehicle on upper lesion A and MK-0873 on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
848988|NCT01235728|P4|Participant Flow|Treatment Sequence 4|Participants were randomized to receive MK-0873 on lower lesion A and vehicle on lower lesion B, and calcitriol on upper lesion C and MK-873 on upper lesion D.
848989|NCT01235728|P3|Participant Flow|Treatment Sequence 3|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and calcitriol on lower lesion C and MK-0873 on lower lesion D.
848991|NCT01235728|P1|Participant Flow|Treatment Sequence 1|Participants were randomized to receive MK-0873 on upper lesion A and vehicle on upper lesion B, and MK-0873 on lower lesion C and calcitriol on lower lesion D.
848992|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK- 0873 on upper or lower lesion A or B and MK-0873 Vehicle on the opposing lesion B or A, and MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C.
848993|NCT01235728|O2|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
848994|NCT01235728|O1|Outcome|Calcitriol 0.0003%|Participants were randomly assigned to receive calcitriol 0.0003% (3mg/g) BID for 28 days on upper or lower lesion C or D and MK-0873 on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
848995|NCT01235728|O2|Outcome|MK-0873 Vehicle|Participants were randomized to receive MK-0873 vehicle on upper or lower lesion A or B and MK-0873 on the opposing lesion B or A. The lesion receiving MK-0873 vehicle was evaluated.
848996|NCT01235728|O1|Outcome|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving MK-0873 was evaluated.
848997|NCT01235728|E1|Reported Event|MK-0873|Participants were randomized to receive MK-0873 on upper or lower lesion C or D and calcitriol on the opposing lesion D or C. The lesion receiving calcitriol was evaluated.
848998|NCT01235715|B3|Baseline|Total|Total of all reporting groups
848999|NCT01235715|B2|Baseline|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849000|NCT01235715|B1|Baseline|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849001|NCT01235715|P2|Participant Flow|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849002|NCT01235715|P1|Participant Flow|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849003|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849004|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849005|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849006|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849007|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849008|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849009|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849010|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849011|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849012|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849013|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849014|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849015|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
850863|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
849016|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849017|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849045|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
851448|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
849018|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849019|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849020|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849021|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849022|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849023|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849024|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849025|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849026|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849027|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849028|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849029|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849030|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849031|NCT01235715|O2|Outcome|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849032|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849033|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849034|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849035|NCT01235715|O2|Outcome|No Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849036|NCT01235715|O1|Outcome|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849037|NCT01235715|E2|Reported Event|no Evicel|Patients will receive standard treatment for bleeding as practiced at HSS.
849038|NCT01235715|E1|Reported Event|Evicel|Evicel is a fibrin sealant used for hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical. It has been shown to stop bleeding in 2 minutes or less. Evicel is a combination of a biologic activated component containing human fibrinogen and topical thrombin that functions on wet, actively bleeding tissue. It is a bioresorbable and biocompatible agent.
849039|NCT01235598|B3|Baseline|Total|Total of all reporting groups
849040|NCT01235598|B2|Baseline|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849041|NCT01235598|B1|Baseline|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849042|NCT01235598|P2|Participant Flow|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849043|NCT01235598|P1|Participant Flow|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849044|NCT01235598|O2|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849718|NCT01233232|P1|Participant Flow|Placebo|4 x placebo capsules, twice daily (bid)
849047|NCT01235598|O1|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849048|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849049|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849050|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849051|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849052|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849053|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849054|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849055|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849056|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849057|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849058|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849059|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849060|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849061|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849062|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849063|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849064|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849065|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849066|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849067|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849068|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849069|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849070|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849071|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849072|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849073|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849207|NCT01235195|E1|Reported Event|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
849208|NCT01234922|B5|Baseline|Total|Total of all reporting groups
849074|NCT01235598|O2|Outcome|Placebo Followed by Certolizumab Pegol (CZP)|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
849075|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849076|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849077|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
851449|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
849078|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849079|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849080|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849081|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849082|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849083|NCT01235598|O1|Outcome|Certolizumab Pegol (CZP)|Certolizumab Pegol (CZP) 400 mg for subcutaneous injection at Weeks 0, 2 and 4 followed by 200 mg 2-weekly from Week 6 to Week 40
849084|NCT01235598|E1|Reported Event|Certolizumab Pegol (CZP) at Any Time|"Eligible subjects were allocated to the following study treatments in a 2:1 ratio:~Certolizumab Pegol (CZP) 400mg for subcutaneous injection (sc) at Weeks 0, 2, and 4, followed by CZP 200mg sc and placebo (saline solution) at Week 6 and CZP 200mg at Weeks 8, 10, 12, 14, and 16 or~Placebo (saline solution) at Day 0 and then CZP 400mg sc at Weeks 2, 4, and 6 followed by CZP 200mg sc at Weeks 8, 10, 12, 14, and 16"
849085|NCT01235507|B1|Baseline|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849086|NCT01235507|P1|Participant Flow|Tocilizumab Plus Methotrexate (MTX)|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum 800 mg) intravenously (IV) every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg per week (mg/week) of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849087|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849088|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849089|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849090|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849091|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849092|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849093|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849094|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849095|NCT01235507|O1|Outcome|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849209|NCT01234922|B4|Baseline|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
850597|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
849096|NCT01235507|E1|Reported Event|Tocilizumab Plus MTX|Participants received tocilizumab 8 mg/kg (maximum 800 mg) IV every 4 weeks for a total of 6 infusions along with methotrexate stable dose as prescribed. Participants also received a stable dose of at least 5 mg/week of folate (or equivalent) given as either a single dose or divided into daily doses to achieve at least 5 mg/week, per investigator discretion.
849097|NCT01235442|B3|Baseline|Total|Total of all reporting groups
849098|NCT01235442|B2|Baseline|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849099|NCT01235442|B1|Baseline|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849100|NCT01235442|P2|Participant Flow|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849101|NCT01235442|P1|Participant Flow|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849102|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849103|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849104|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849105|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849106|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849107|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849108|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849109|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849110|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849111|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849112|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849113|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849114|NCT01235442|O2|Outcome|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849115|NCT01235442|O1|Outcome|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849116|NCT01235442|E2|Reported Event|Etanercept + Clobetasol Propionate Foam|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks). In addition, subjects received topical clobetasol propionate foam twice daily during weeks 11, 12, 23, and 24 as needed until skin was clear of detectable psoriasis (except in proscribed areas).
849117|NCT01235442|E1|Reported Event|Etanercept Monotherapy|Etanercept 50 mg SC twice weekly for 12 weeks and then 50 mg SC once weekly for 12 weeks (a total of 24 weeks).
849118|NCT01235403|B1|Baseline|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
849119|NCT01235403|P1|Participant Flow|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
849120|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
849121|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
849122|NCT01235403|O1|Outcome|Lacosamide|"Flexible dosing between 200 mg/day and 400 mg/day~Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
849123|NCT01235403|E1|Reported Event|Lacosamide|"Flexible dosing between 200mg/day and 400mg/day~Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.~Taper phase if needed: 3 to 4 weeks"
849124|NCT01235377|B3|Baseline|Total|Total of all reporting groups
849125|NCT01235377|B2|Baseline|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849126|NCT01235377|B1|Baseline|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849127|NCT01235377|P2|Participant Flow|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849128|NCT01235377|P1|Participant Flow|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849129|NCT01235377|O2|Outcome|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849130|NCT01235377|O1|Outcome|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849131|NCT01235377|E2|Reported Event|Favor Hydrochlorothiazide|Providers randomized to Favor Hydrochlorothiazide agreed to prescribe hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849132|NCT01235377|E1|Reported Event|Favor Chlorthalidone|Providers randomized to Favor Chlorthalidone agreed to prescribe chlorthalidone for patients who are to be newly prescribed a thiazide for hypertension. This cluster designation applies only for patients for whom there is equipoise; providers are expected to deviate if medically indicated for individual patients
849133|NCT01235338|B3|Baseline|Total|Total of all reporting groups
849134|NCT01235338|B2|Baseline|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849135|NCT01235338|B1|Baseline|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849136|NCT01235338|P2|Participant Flow|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849137|NCT01235338|P1|Participant Flow|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849138|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849210|NCT01234922|B3|Baseline|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
849211|NCT01234922|B2|Baseline|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
850881|NCT01229228|O4|Outcome|Naprosyn 500 mg|
849139|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849214|NCT01234922|P3|Participant Flow|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
849215|NCT01234922|P2|Participant Flow|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
849140|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849141|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849142|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849143|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849144|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849145|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849146|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849147|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849148|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849149|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849150|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849151|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849152|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849153|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849216|NCT01234922|P1|Participant Flow|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
849217|NCT01234922|O4|Outcome|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
849154|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849155|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849156|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849157|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849158|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849159|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849160|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849161|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849162|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849163|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849164|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849165|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849166|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849167|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849212|NCT01234922|B1|Baseline|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
849213|NCT01234922|P4|Participant Flow|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
849168|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849169|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849170|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849171|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849172|NCT01235338|O2|Outcome|Venlafaxine XR + LDX|Venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 1-5, then venlafaxine XR 150 mg QD Days 6-10, then venlafaxine XR 225 mg QD Days 11-15, then venlafaxine XR 225 mg + LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg QD Days 16-20, then venlafaxine XR 225 mg + LDX 50 mg QD Days 21-25, then venlafaxine XR 225 mg + LDX 70 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849173|NCT01235338|O1|Outcome|LDX + Venlafaxine XR|LDX (Lisdexamfetamine Dimesylate, SPD489, Vyvanse®) 30 mg once daily (QD) Days 1-5, then LDX 50 mg QD Days 6-10, then LDX 70 mg QD Days 11-15, then LDX 70 mg + venlafaxine XR (Venlafaxine Hydrochloride extended-release, Effexor® XR) 75 mg QD Days 16-20, then LDX 70 mg + venlafaxine XR 150 mg QD Days 21-25, then LDX 70 mg + venlafaxine XR 225 mg QD Days 26-30, then venlafaxine XR 150 mg QD Days 31-34, then venlafaxine XR 75 mg QD Days 35-38.
849174|NCT01235338|E4|Reported Event|Venlafaxine XR Tapering|Tapering dosing period (Effexor XR 150 and 75 mg)
849175|NCT01235338|E3|Reported Event|Venlafaxine XR Titration|Titration dosing period (Effexor XR 75, 150, and 225 mg)
849176|NCT01235338|E2|Reported Event|LDX + Venlafaxine XR/Venlafaxine XR + LDX|Combination dosing periods
849177|NCT01235338|E1|Reported Event|LDX (SPD489)|Titration dosing period
849178|NCT01235234|B4|Baseline|Total|Total of all reporting groups
849179|NCT01235234|B3|Baseline|Placebo|CF101: orally q12h
849180|NCT01235234|B2|Baseline|CF101 1 mg|CF101: orally q12h
849181|NCT01235234|B1|Baseline|CF101 0.1 mg|CF101: orally q12h
849182|NCT01235234|P3|Participant Flow|Placebo|CF101: orally q12h
849183|NCT01235234|P2|Participant Flow|CF101 1 mg|CF101: orally q12h
849184|NCT01235234|P1|Participant Flow|CF101 0.1 mg|CF101: orally q12h
849185|NCT01235234|O3|Outcome|Placebo|CF101: orally q12h
849186|NCT01235234|O2|Outcome|CF101 1 mg|CF101: orally q12h
849187|NCT01235234|O1|Outcome|CF101 0.1 mg|CF101: orally q12h
849188|NCT01235234|E3|Reported Event|Placebo|CF101: orally q12h
849189|NCT01235234|E2|Reported Event|CF101 1 mg|CF101: orally q12h
849190|NCT01235234|E1|Reported Event|CF101 0.1 mg|CF101: orally q12h
849191|NCT01235195|B1|Baseline|Entire Study Population|Entire study population receiving Sertraline Hydrochloride 50 mg as either hard gelatin capsule or film-coated tablet
849192|NCT01235195|P2|Participant Flow|Sertraline 50 mg Tablet, Then Sertraline 50 mg Capsule|Sertraline Hydrochloride 50 mg film-coated tablet in the first intervention period, Sertraline Hydrochloride 50 mg hard gelatin capsule in the second intervention period
849193|NCT01235195|P1|Participant Flow|Sertraline 50 mg Capsule, Then Sertraline 50 mg Tablet|Sertraline Hydrochloride 50 milligram (mg) hard gelatin capsule in the first intervention period, Sertraline Hydrochloride 50 mg Film-Coated Tablet in the second intervention period
849194|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
849195|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
849196|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
849197|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
849198|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
849199|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
849200|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
849201|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
849202|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
849203|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
849204|NCT01235195|O2|Outcome|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
849205|NCT01235195|O1|Outcome|Sertraline 50 mg Hard Gelatin Capsule|All participants receiving Sertraline Hydrochloride 50 mg Hard Gelatin Capsule
849206|NCT01235195|E2|Reported Event|Sertraline 50 mg Film-Coated Tablet|All participants receiving Sertraline Hydrochloride 50 mg Film-Coated Tablet
850882|NCT01229228|O3|Outcome|Naprosyn 250 mg|
849218|NCT01234922|O3|Outcome|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
849219|NCT01234922|O2|Outcome|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
849220|NCT01234922|O1|Outcome|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
849221|NCT01234922|E4|Reported Event|Arm IV|"Patients receive oral losartan potassium once daily on days 1-7.~losartan potassium: Given orally~laboratory biomarker analysis: Correlative studies"
849222|NCT01234922|E3|Reported Event|Arm III|"Patients receive oral ramipril twice daily on days 1-7.~laboratory biomarker analysis: Correlative studies~ramipril: Given orally"
849223|NCT01234922|E2|Reported Event|Arm II|"Patients receive oral lisinopril once daily on days 1-7.~lisinopril: Given orally~laboratory biomarker analysis: Correlative studies"
849224|NCT01234922|E1|Reported Event|Arm I|"Patients receive oral benazepril hydrochloride once daily on days 1-7.~laboratory biomarker analysis: Correlative studies~benazepril hydrochloride: Given orally"
849225|NCT01234883|B3|Baseline|Total|Total of all reporting groups
849226|NCT01234883|B2|Baseline|0.9% Saline|saline: IV saline solution dosed as clinically indicated for rehydration
849227|NCT01234883|B1|Baseline|Plasma-Lyte A|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
849228|NCT01234883|P2|Participant Flow|Saline|0.9% Normal Saline: IV saline solution dosed as clinically indicated for rehydration
849229|NCT01234883|P1|Participant Flow|Multiple Electrolyte Solution|Plasma Lyte A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP): IV multiple electrolyte solution dosed as clinically indicated for rehydration.
849230|NCT01234883|O2|Outcome|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
849231|NCT01234883|O1|Outcome|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
849232|NCT01234883|E2|Reported Event|Saline|saline: IV saline solution dosed as clinically indicated for rehydration
849233|NCT01234883|E1|Reported Event|Multiple Electrolyte Solution|multiple electrolyte solution: IV multiple electrolyte solution dosed as clinically indicated for rehydration
849234|NCT01234870|B1|Baseline|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
849235|NCT01234870|P1|Participant Flow|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
849236|NCT01234870|O1|Outcome|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
849237|NCT01234870|O1|Outcome|Ischemic Heart Disease Patients|Patients with suspected ischemic heart disease prospectively recruited for first pass myocardial perfusion MRI. All subject to receive Gadolinium infusion of 0.075 mmol/kg at rate of 4 ml/sec. Adenosine administered at a rate of 0.14 mg/kg/min for a duration of 4 minutes to induce stress.
849238|NCT01234870|E1|Reported Event|Adenosine|"Adenosine (Adenoscan) will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins.~adenosine: Adenosine will be infused intravenously at a dose of 0.14mg/kg/min for a total of 4 mins"
849239|NCT01234831|B3|Baseline|Total|Total of all reporting groups
849240|NCT01234831|B2|Baseline|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
849241|NCT01234831|B1|Baseline|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
849242|NCT01234831|P2|Participant Flow|Passive Screening|Patients randomized to passive screening will not actively be identified for testing but may be tested using culture-based algorithm by care team.
849243|NCT01234831|P1|Participant Flow|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
849244|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
849245|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
849246|NCT01234831|O1|Outcome|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
849247|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
849248|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
849249|NCT01234831|O2|Outcome|Passive Screening|Patients randomized to the Passive Screening arm will not actively be identified for testing but may be tested using institutional culture-based protocol available to all primary care teams.
849250|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
849251|NCT01234831|O1|Outcome|Active Screening|Patients randomized to the Active Screening arm will have paired nasal swabs collected daily for 3 days; one processed using nucleic acid amplification and the other using culture (CHROMagar) assays.
849252|NCT01234831|E1|Reported Event|Active Screening|Patients randomized to active screening will have two nasal swabs collected daily for 3 days, for both nucleic acid amplification and culture (CHROMagar)assays.
851450|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
849253|NCT01234714|B1|Baseline|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
849254|NCT01234714|P1|Participant Flow|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
849255|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849256|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849257|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849258|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849259|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849260|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849261|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849262|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849263|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849264|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849265|NCT01234714|O2|Outcome|Patient Group With Liver Fat Content >10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849266|NCT01234714|O1|Outcome|Patient Group With Liver Fat Content <10% on MRI|Pre-operative Magnetic Resonance Imaging (MRI) liver fat content measurement (in percentage).
849267|NCT01234714|O2|Outcome|Clavien-Dindo Grade ≥IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~These are typically life-threatening complication (including CNS complications) requiring ICU management.~Grade IVa: single organ dysfunction (including dialysis)~Grade IVb: multi-organ dysfunction"
849268|NCT01234714|O1|Outcome|Clavien-Dindo Grade <IV Complications|"Percentage of liver fat content on MRI in patients with Clavien-Dindo Grade <IV complications.~No complications: Patients without any post-operative complications defined according to the Clavien-Dindo Classification.~Grade 1: Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions. Allowed therapeutic regimens are: drugs as antiemetics, antipyretics, analgetics, diuretics and electrolytes and physiotherapy. This grade also includes wound infections opened at the bedside.~Grade II: Requiring pharmacological treatment with drugs other than such allowed for grade I complications.~Blood transfusions and total parenteral nutrition are also included.~Grade III:Requiring surgical, endoscopic or radiological intervention"
849269|NCT01234714|E1|Reported Event|Major Liver Resection|This single Cohort/Group will include all consecutive patients that received pre-operative Magnetic Resonant Imaging (MRI) and underwent major liver resection (>=3 segments).
849270|NCT01234675|B1|Baseline|All Study Participants|2 treatment period, with each period 6 weeks and 7 day washout period Milnacipran in treatment period 1, Placebo in treatment period 2 Placebo treatment in Period 1, and Milnacipran in Period 2
849271|NCT01234675|P2|Participant Flow|Milnacipran Then Placebo|50 mg BiD maintenance dose
849272|NCT01234675|P1|Participant Flow|Placebo Then Milnacipran|50 mg BiD maintenance dose
849273|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
849274|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
849275|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
849276|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
849277|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
849278|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
849279|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
849280|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
849281|NCT01234675|O2|Outcome|Placebo|50 mg placebo BiD
849282|NCT01234675|O1|Outcome|Milnacipran|Treatment with 50 mg BiD
849283|NCT01234675|E2|Reported Event|Placebo|Drug: Placebo 50 mg, twice daily for 4 weeks.
849284|NCT01234675|E1|Reported Event|Milnacipran|Drug: milnacipran, 50 mg twice daily for 4 weeks.
849285|NCT01234467|B1|Baseline|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849543|NCT01232868|E1|Reported Event|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849296|NCT01234337|B1|Baseline|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849717|NCT01233232|P2|Participant Flow|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849286|NCT01234467|P1|Participant Flow|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849287|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849288|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849289|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849290|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849291|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849292|NCT01234467|O1|Outcome|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849293|NCT01234467|E1|Reported Event|Bendamustine, Rituximab|"This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m^2 daily with a dose increase to 120 mg/m^2 daily if their ECOG improved.~Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles~Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles"
849294|NCT01234337|B3|Baseline|Total|Total of all reporting groups
849295|NCT01234337|B2|Baseline|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849363|NCT01233869|B3|Baseline|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849544|NCT01232829|B1|Baseline|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
849297|NCT01234337|P2|Participant Flow|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849298|NCT01234337|P1|Participant Flow|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849299|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849300|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849301|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849302|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849303|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849304|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849305|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849306|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849307|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849364|NCT01233869|B2|Baseline|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
850864|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
849308|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849309|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849310|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849311|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849312|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849313|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849314|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849315|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849316|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849317|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849318|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849319|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849320|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849365|NCT01233869|B1|Baseline|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849596|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849321|NCT01234337|O2|Outcome|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849322|NCT01234337|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849323|NCT01234337|E2|Reported Event|Sorafenib(Nexavar, BAY43-9006) + Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
849324|NCT01234337|E1|Reported Event|Placebo + Capecitabine|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
849325|NCT01234207|B1|Baseline|All Study Participants|Crossover trial: all study participants received both Test and Control spectacles, in randomized order.
849326|NCT01234207|P2|Participant Flow|Group 2 - Test Spectacles Worn First, Then Control Spectacles|Crossover trial; 2 arms: subjects randomized to wear Test spectacles 1st, then Control spectacles 2nd
849327|NCT01234207|P1|Participant Flow|Group 1 - Control Spectacles Worn First, Then Test Spectacles|Crossover trial; 2 arms: subjects randomized to wear Control spectacles 1st, then Test spectacles 2nd
849328|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849329|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849330|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849331|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849332|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849333|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849334|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849335|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention"
849336|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849337|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849338|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849339|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849340|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849341|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849342|NCT01234207|O2|Outcome|Test Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849343|NCT01234207|O1|Outcome|Control Spectacles|"Arm/Groups Outcome Measures are reported per intervention."
849344|NCT01234207|E2|Reported Event|Test Spectacles|"Arm/Groups Adverse Events are reported per intervention"
849345|NCT01234207|E1|Reported Event|Control Spectacles|"Arm/Groups Adverse Events are reported per intervention"
849346|NCT01233999|B1|Baseline|Botox|single-drug dosage comparison cross-over study
849347|NCT01233999|P1|Participant Flow|Botox|Participants will be randomly assigned to receive 1 injection with Botulinum toxin A, 40 units in either the left or right hand.
849348|NCT01233999|O1|Outcome|Botox|single-drug dosage comparison cross-over study
849349|NCT01233999|E1|Reported Event|Botox|single-drug dosage comparison cross-over study
849350|NCT01233921|B3|Baseline|Total|Total of all reporting groups
849351|NCT01233921|B2|Baseline|Arm II (no Palifermin)|Patients do not receive palifermin.
849352|NCT01233921|B1|Baseline|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
849353|NCT01233921|P2|Participant Flow|Arm II (no Palifermin)|Patients do not receive palifermin.
849354|NCT01233921|P1|Participant Flow|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
849355|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
849356|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
849357|NCT01233921|O2|Outcome|Arm II (no Palifermin)|Patients do not receive palifermin.
849358|NCT01233921|O1|Outcome|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
849359|NCT01233921|E2|Reported Event|Arm II (no Palifermin)|Patients do not receive palifermin.
849360|NCT01233921|E1|Reported Event|Arm I (Palifermin)|Patients receive palifermin IV on days 1-3 in the absence of unacceptable toxicity.
849361|NCT01233869|B5|Baseline|Total|Total of all reporting groups
849362|NCT01233869|B4|Baseline|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849366|NCT01233869|P4|Participant Flow|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849367|NCT01233869|P3|Participant Flow|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849368|NCT01233869|P2|Participant Flow|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849369|NCT01233869|P1|Participant Flow|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849370|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849371|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849372|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849373|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849374|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849375|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849376|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849377|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849378|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849379|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849380|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849381|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849382|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849383|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849384|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849385|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849386|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849387|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849388|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849389|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849390|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849391|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849392|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849393|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849394|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849395|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849396|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849397|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849398|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849399|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849400|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849401|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849402|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849403|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849404|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849405|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849406|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849450|NCT01233869|E4|Reported Event|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849407|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849408|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849409|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849410|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849411|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849412|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849413|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849414|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849415|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849416|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849417|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849418|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849419|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849420|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849421|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849422|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849423|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849424|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849425|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849426|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849427|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849541|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849428|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849429|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849430|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849431|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849432|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849433|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849434|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849435|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849436|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849437|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849438|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849439|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849440|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849441|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849442|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849443|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849444|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849445|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849446|NCT01233869|O4|Outcome|Placebo|Participants received placebo tablet orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive placebo matched bosutinib QD for up to 46 months.
849447|NCT01233869|O3|Outcome|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849448|NCT01233869|O2|Outcome|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849449|NCT01233869|O1|Outcome|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849451|NCT01233869|E3|Reported Event|Bosutinib 400/200 mg/Day|Participants received bosutinib 400 mg and were dose-reduced to 200 mg tablet (based on protocol amendment) orally QD in the morning with food for 24 months in the ITP. After a 30-day washout period, participants who entered the ETP continued to receive bosutinib 200 mg orally QD for up to 46 months.
849452|NCT01233869|E2|Reported Event|Bosutinib 400 mg/Day|Participants received bosutinib 400 mg tablet orally QD in the morning with food for 24 months in the ITP. All participants were dose-reduced during the ITP based on a protocol amendment. Those who remained active in the study at the time of the amendment are represented in the bosutinib 400/200 mg/day group.
849453|NCT01233869|E1|Reported Event|Bosutinib 200 mg/Day|Participants received bosutinib 200 mg tablet orally once daily (QD) in the morning with food for 24 months in the Initial Treatment Period (ITP). After a 30-day washout period, participants who entered the Extended Treatment Period (ETP) continued to receive bosutinib 200 mg orally QD for up to 46 months.
849454|NCT01233817|B1|Baseline|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
849455|NCT01233817|P1|Participant Flow|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
849456|NCT01233817|O1|Outcome|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
849457|NCT01233817|E1|Reported Event|Spinal Muscular Atrophy|Children and adolescents with diagnosis of SMA type II or III
849458|NCT01233726|B4|Baseline|Total|Total of all reporting groups
849459|NCT01233726|B3|Baseline|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Nutrition, Madrid, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
849460|NCT01233726|B2|Baseline|ISOSOURCE PROTEIN FIBRE|"Patients of this group will received ISOSOURCE PROTEIN FIBRE (Nestlé Health Science, barcelona, Spain) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
849461|NCT01233726|B1|Baseline|DIABA HP|"Patients of this group received new-generation diabetes-specific high-protein formula (Diaba HP®, Vegenat, Badajoz, Spain); as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg/ day for 28 days, via gastric or transpyloric."
849462|NCT01233726|P3|Participant Flow|GLUCERNA SELECT|"Patients of this group received GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will received 25 kcal / kg / day for 28 days, via gastric or transpyloric."
849463|NCT01233726|P2|Participant Flow|ISOSOURCE PROTEIN FIBRE|"Patients of this group received ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
849464|NCT01233726|P1|Participant Flow|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
849465|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849466|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849467|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849468|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849469|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849545|NCT01232829|P1|Participant Flow|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
849550|NCT01232790|B1|Baseline|Participants|This is the overall group of trial participants prior to randomization to either of the two crossover arms in the study.
849597|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
849470|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
849471|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849472|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849473|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
849474|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849475|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849476|NCT01233726|O1|Outcome|DIABA HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP GROUP received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
849477|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849478|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849479|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849480|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849481|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849482|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849483|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849484|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849485|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849486|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849487|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849488|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849489|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849490|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849491|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849492|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849493|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849494|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849495|NCT01233726|O3|Outcome|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~Group GLUCERNA SELECT will receive 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849496|NCT01233726|O2|Outcome|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg • day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~Group Isosource protein fibre will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric."
849497|NCT01233726|O1|Outcome|Diaba HP|"Patients of this group received Diaba HP as unique nutritional support throughout the day, receiving 25 kcal / kg /day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP: Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~Group Diaba HP received, 25 kcal / kg /day for 28 days"
849498|NCT01233726|E3|Reported Event|GLUCERNA SELECT|"Patients of this group will receive GLUCERNA SELECT (Abbott Laboratories) as unique nutritional support throughout the day, receiving 25 kcal / kg/ day (from the first 48 hours after checking tolerance) via gastric or transpyloric~GLUCERNA SELECT: Glucerna Select is a complete high protein special formula, with fiber, enriched in monounsaturated fatty acids, with slow absorption carbohydrates.~GLUCERNA SELECT group will receive 25 kcal / kg / day for 28 days, via gastric or transpyloric."
849499|NCT01233726|E2|Reported Event|ISOSOURCE PROTEIN FIBRE|"Patients of this group will receive ISOSOURCE PROTEIN FIBRE (Nestlé Nutrition) as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~ISOSOURCE PROTEIN FIBRE: Isosource protein fibre is a complete high protein diet with fibre mixture.~ISOSOURCE PROTEIN FIBRE group received, 25 kcal / kg / day for 28 days, via gastric or transpyloric."
849627|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849500|NCT01233726|E1|Reported Event|DIABA HP|"Patients of this group received Diaba HP® as unique nutritional support throughout the day, receiving 25 kcal / kg / day (from the first 48 hours after checking tolerance) via gastric or transpyloric~Diaba HP is a complete normocaloric high protein diet, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.~DIABA HP group received, 25 kcal / kg /day for 28 days, via gastric or transpyloric."
849509|NCT01232920|B3|Baseline|Total|Total of all reporting groups
849510|NCT01232920|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
849511|NCT01232920|B1|Baseline|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
849512|NCT01232920|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
849513|NCT01232920|P1|Participant Flow|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
849514|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
849515|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
849516|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
849517|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
849542|NCT01232868|E2|Reported Event|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849518|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
849595|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
849519|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
849520|NCT01232920|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
849521|NCT01232920|O1|Outcome|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
849522|NCT01232920|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil: Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
849523|NCT01232920|E1|Reported Event|Methotrexate|Methotrexate: All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
849524|NCT01232894|B3|Baseline|Total|Total of all reporting groups
849525|NCT01232894|B2|Baseline|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
849526|NCT01232894|B1|Baseline|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
849527|NCT01232894|P2|Participant Flow|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
849528|NCT01232894|P1|Participant Flow|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
849529|NCT01232894|O2|Outcome|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
849530|NCT01232894|O1|Outcome|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
849531|NCT01232894|E2|Reported Event|Long-acting beta2-agonist|Participants' current long-acting beta2-agonist (LABA) bronchodilator therapy
849532|NCT01232894|E1|Reported Event|Indacaterol|indacaterol 150 µg once-daily via single-dose dry powder inhaler
849533|NCT01232868|B3|Baseline|Total|Total of all reporting groups
849534|NCT01232868|B2|Baseline|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849535|NCT01232868|B1|Baseline|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849536|NCT01232868|P2|Participant Flow|Age ≥65 Years|Healthy participants 65 years or older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849537|NCT01232868|P1|Participant Flow|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849538|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849539|NCT01232868|O1|Outcome|Age 25-40 Years|Healthy participants between the ages of 25 to 40 years of age received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
849540|NCT01232868|O2|Outcome|Age ≥65 Years|Healthy participants 65 years and older received 0.5 ml of the trivalent Influenza vaccine (TIV) administered via the intramuscular route in the deltoid muscle as a single dose.
850865|NCT01229371|E4|Reported Event|Subjects >60 Years - CSL HA Antigen|
849546|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
849547|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
849548|NCT01232829|O1|Outcome|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
849549|NCT01232829|E1|Reported Event|Treatment (RO4929097)|RO4929097 was administered at a dose of 20 mg daily on days 1-3, 8-10 and 15-17 of 21-day cycles.
849551|NCT01232790|P2|Participant Flow|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
849552|NCT01232790|P1|Participant Flow|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849553|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
849554|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849555|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
849556|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849557|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days , then receives commercially available sustained release form of NAC for the same period (8 total doses over 5 days).
849558|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849559|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849560|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849561|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849562|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849563|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849564|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849565|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849566|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849567|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849628|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849629|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849568|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849569|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849713|NCT01233232|B3|Baseline|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849570|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849571|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
849572|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849573|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849574|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849575|NCT01232790|O2|Outcome|Placebo|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849576|NCT01232790|O1|Outcome|Intervention|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849577|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
849578|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849579|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849580|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849581|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849582|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849583|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849584|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849585|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and then receives the commercially available sustained release form of NAC. Both are administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days).
849586|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849587|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
849588|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849589|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
849590|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849591|NCT01232790|O2|Outcome|Placebo|This is the combined placebo/control group (both those receiving the placebo first and those receiving the placebo second).
849592|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849630|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849631|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849593|NCT01232790|O2|Outcome|Group B: Placebo 1st Trial, NAC 2nd Trial|Group B first receives the placebo and the receives rge commercially available sustained release form of NAC, in each arm the capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849594|NCT01232790|O1|Outcome|Group A: NAC 1st Trial, Placebo 2nd Trial|Group A first receives the commercially available sustained release form of NAC, then the matching placebo capsules both administered at 1200mg twice a day for 3 full days, along with 1200mg once on the evening prior to and once on the morning following the 3 days (8 total doses over 5 days.
849598|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849599|NCT01232790|O2|Outcome|Placebo|This is the combined placebo group (both those receiving the placebo first and those receiving the placebo second).
849600|NCT01232790|O1|Outcome|Intervention|This is the combined intervention group (both those receiving the intervention first and those receiving the intervention second).
849601|NCT01232790|E4|Reported Event|NAC: Second Crossover Follow Up|This group of participants received the active treatment (NAC) on the second day of the crossover study.
849602|NCT01232790|E3|Reported Event|Placebo: Second Crossover Follow Up|This group of participants received the placebo on the second day in the crossover design.
849603|NCT01232790|E2|Reported Event|NAC: First Crossover Follow Up|This group of participants received the active treatment (NAC) on the first day of the crossover study.
849604|NCT01232790|E1|Reported Event|Placebo: First Crossover Follow Up|This group of participants received the placebo on the first day in the crossover design.
849605|NCT01233284|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
849606|NCT01233284|P5|Participant Flow|Placebo/Tio R2.5 qd/Tio R5 qd/Tio R1.25 qd|Patient treated with a matching Placebo in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
849607|NCT01233284|P4|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 qd/Tio R1.25 qd|Patients treated with a matching Placebo in period 1 (evening), with Tiotropium 5 mcg in period 2 (evening), with Tiotropium 2.5 mcg in period 3 (evening) and with Tiotropium 1.25 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
849608|NCT01233284|P3|Participant Flow|Tio R1.25 qd/Tio R2.5 qd/Tio R5 qd/Placebo|Patients treated with Tiotropium 1.25 mcg in period 1 (evening), with Tiotropium 2.5 mcg in period 2 (evening), with Tiotropium 5 mcg in period 3 (evening) and with a matching placebo in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroid ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
849609|NCT01233284|P2|Participant Flow|Tio R2.5 qd/Placebo/Tio R1.25 qd/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (evening), with a matching Placebo in period 2 (evening), with Tiotropium 1.25 mcg in period 3 (evening) and with Tiotropium 5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to ICS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
849610|NCT01233284|P1|Participant Flow|Tio R5 Once Daily(qd)/Tio R1.25 qd/Placebo/Tio R2.5 qd|Patients treated with Tiotropium 5 mcg in period 1 (evening), with Tiotropium 1.25 mcg in period 2 (evening), with a matching Placebo in period 3 (evening) and with Tiotropium 2.5 mcg in period 4 (evening). All products were delivered by the Respimat inhaler as add-on therapy to inhaled corticosteroids (ICS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
849611|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849612|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849613|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849614|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849615|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849616|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849617|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849618|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849619|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849620|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849621|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849622|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849623|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849624|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849625|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849626|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
850866|NCT01229371|E3|Reported Event|Subjects >60 Years - AdImmune HA Antigen|
849633|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849634|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849635|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849636|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849637|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849638|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849639|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849640|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849714|NCT01233232|B2|Baseline|AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849641|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849642|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849643|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849644|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849645|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849646|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849647|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849648|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849649|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849650|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849651|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849652|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849653|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849654|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849655|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849656|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849657|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849658|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849659|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849660|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849661|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849662|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849663|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849664|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849665|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849666|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849667|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849668|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849669|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849670|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849671|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849672|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849673|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849674|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849675|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849676|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849677|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849678|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849679|NCT01233284|O4|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849680|NCT01233284|O3|Outcome|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849681|NCT01233284|O2|Outcome|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849682|NCT01233284|O1|Outcome|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849683|NCT01233284|E4|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849684|NCT01233284|E3|Reported Event|Tio R2.5 qd|Tiotropium 2.5 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849685|NCT01233284|E2|Reported Event|Tio R1.25 qd|Tiotropium 1.25 mcg qd in the evening delivered by the Respimat inhaler as add-on therapy to ICS.
849686|NCT01233284|E1|Reported Event|Placebo|Matching Placebo qd in the evening delivered by the Respimat inhaler.
849687|NCT01233258|B4|Baseline|Total|Total of all reporting groups
849688|NCT01233258|B3|Baseline|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
849689|NCT01233258|B2|Baseline|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
849690|NCT01233258|B1|Baseline|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
849691|NCT01233258|P6|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII(BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
849692|NCT01233258|P5|Participant Flow|High Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
849693|NCT01233258|P4|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First ADJ Then EP|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) measured by CS/ADJ for 6 months then crossed over to study drug measured by CS/ EP for 6 months.
849694|NCT01233258|P3|Participant Flow|Low Dose Prophylaxis, BAY 81-8973 Potency First EP Then ADJ|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII(BAY81-8973) measured by CS/ EP for 6 months then crossed over to study drug measured by CS/ADJ for 6 months.
849695|NCT01233258|P2|Participant Flow|On Demand, BAY 81-8973 Potency First ADJ Then EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ for 6 months, followed by cross-over to study drug assayed by CS/EP for 6 months.
849696|NCT01233258|P1|Participant Flow|On Demand, BAY 81-8973 Potency First EP Then ADJ|Participants received on-demand treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months, followed by cross-over to study drug assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months.
849697|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
849698|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
849699|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
849700|NCT01233258|O3|Outcome|rFVIII (BAY81-8973) Prophylaxis High-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at high-dose (30, 35 or 40 IU/kg 3 times per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
849701|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Low-dose|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
849702|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
849703|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
849704|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
849705|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/ADJ|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
849706|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/ADJ|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months
849707|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment Assayed by CS/EP|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months.
849708|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand Assayed by CS/EP|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months
849709|NCT01233258|O2|Outcome|rFVIII (BAY81-8973) Prophylaxis Treatment|Participants received prophylaxis treatment with rFVIII (BAY81-8973) at low-dose (20, 25 or 30 IU/kg twice per week ) and high-dose (30, 35 or 40 IU/kg 3 times per week ) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization.
849710|NCT01233258|O1|Outcome|rFVIII (BAY81-8973) on Demand|Participants received on-demand treatment rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
849711|NCT01233258|E1|Reported Event|rFVIII (BAY81-8973) Treatment|Participants received on-demand or prophylaxis treatment with recombinant factor VIII (rFVIII, BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization
849712|NCT01233232|B4|Baseline|Total|Total of all reporting groups
849719|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849720|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849721|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849722|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849723|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849724|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849725|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849726|NCT01233232|O2|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849727|NCT01233232|O1|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849728|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849729|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849730|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849731|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849732|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849733|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849734|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849735|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849736|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849737|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849738|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849739|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849740|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849741|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849742|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849743|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849744|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849745|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849746|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849747|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849748|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849749|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849750|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849751|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849752|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849753|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849754|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849755|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849756|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849757|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849758|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849759|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849760|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849761|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849762|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849763|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849764|NCT01233232|O3|Outcome|Arm 3 - AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
849765|NCT01233232|O2|Outcome|Arm 2 - AZD5069 50 mg|1 x 50 mg AZD5069 capsule and 3 x placebo capsules, bid
849766|NCT01233232|O1|Outcome|Arm 1 - Placebo|4 x placebo capsules, twice daily (bid)
849767|NCT01233232|E3|Reported Event|AZD5069 80 mg|4 x 20 AZD5069 mg capsules, bid
851484|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
849771|NCT01233076|P2|Participant Flow|Narafilcon B / Nelfilcon A|Narafilcon B worn first, with nelfilcon A worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
849772|NCT01233076|P1|Participant Flow|Nelfilcon A / Narafilcon B|Nelfilcon A worn first, with narafilcon B worn second. Each product worn bilaterally in a daily wear, daily disposable basis for one week.
849773|NCT01233076|O2|Outcome|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
849774|NCT01233076|O1|Outcome|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
849775|NCT01233076|E2|Reported Event|Narafilcon B|Commercially marketed (US), spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
849776|NCT01233076|E1|Reported Event|Nelfilcon A|Commercially marketed, spherical contact lenses worn bilaterally in a daily wear, daily disposable manner for one week.
849777|NCT01232569|B3|Baseline|Total|Total of all reporting groups
849778|NCT01232569|B2|Baseline|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849779|NCT01232569|B1|Baseline|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849780|NCT01232569|P4|Participant Flow|Tocilizumab Auto-injector - Open-label Extension Period|Patients received tocilizumab 162 mg sc via auto-injector every 2 weeks for 72 weeks.
851451|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
849781|NCT01232569|P3|Participant Flow|Tocilizumab Pre-filled Syringe - Open-label Extension Period|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
849782|NCT01232569|P2|Participant Flow|Placebo sc - Double-blind Treatment Period|Patients received placebo sc every 2 weeks for 24 weeks.
849783|NCT01232569|P1|Participant Flow|Tocilizumab 162 mg sc - Double-blind Treatment Period|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849784|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849785|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849786|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849787|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849788|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849789|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849790|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849791|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849792|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849793|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849794|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849795|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849796|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849797|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849798|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849799|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849800|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849801|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849802|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849803|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849804|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849805|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849806|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849807|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849808|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849809|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849810|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849811|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849812|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849813|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849814|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849815|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849816|NCT01232569|O2|Outcome|Placebo sc|Patients received placebo subcutaneously (sc) every 2 weeks for 24 weeks.
849817|NCT01232569|O1|Outcome|Tocilizumab 162 mg sc|Patients received tocilizumab 162 mg subcutaneously (sc) every 2 weeks for 24 weeks.
849818|NCT01232569|E5|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Autoinjector|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
849933|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
849819|NCT01232569|E4|Reported Event|Placebo Pre-filled Syringe to Tocilizumab Pre-filled Syringe|Patients received placebo sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks.
849820|NCT01232569|E3|Reported Event|Tocilizumab Pre-filled Syringe to Tocilizumab Auto-injector|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks followed by tocilizumab162 mg sc via an autoinjector every 2 weeks for 72 weeks.
849821|NCT01232569|E2|Reported Event|Placebo Pre-filled Syringe|Patients received placebo subcutaneously (sc) via a pre-filled syringe every 2 weeks for 24 weeks.
849822|NCT01232569|E1|Reported Event|Tocilizumab Pre-filled Syringe|Patients received tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 24 weeks. In addition, this reporting group includes participants re-randomized at Week 24 to tocilizumab 162 mg sc via a pre-filled syringe every 2 weeks for 72 weeks (Weeks 25-96).
849823|NCT01232504|B4|Baseline|Total|Total of all reporting groups
849824|NCT01232504|B3|Baseline|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849825|NCT01232504|B2|Baseline|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849826|NCT01232504|B1|Baseline|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849827|NCT01232504|P3|Participant Flow|rhG-CSF Group|subcutaneous recombinant human granulocyte stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849828|NCT01232504|P2|Participant Flow|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) and 2-3μg/kg/d recombinant human granulocyte stimulating factor (rhG-CSF) each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849829|NCT01232504|P1|Participant Flow|rhGM-CSF Group|subcutaneous recombinant human granulocyte-macrophage stimulating factor (rhGM-CSF) 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849830|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849831|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849832|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849833|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849834|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849835|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849836|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849837|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849838|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849839|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849840|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849841|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849842|NCT01232504|O3|Outcome|rhG-CSFgroup|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849843|NCT01232504|O2|Outcome|rhGM-CSF+ rhG-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849844|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849845|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849846|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849847|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849848|NCT01232504|O3|Outcome|rhG-CSF|"5-7μg/kg per day~rhG-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
849849|NCT01232504|O2|Outcome|rhGM-CSF Plus rhG-CSF|"rhGM-CSF and rhG-CSF both at 2-3μg/kg per day~rhGM-CSF plus rhG-CSF: rhGM-CSF and rhG-CSF (both at 2-3μg/kg/d) subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
849850|NCT01232504|O1|Outcome|rhGM-CSF|"5-7μg/kg per day~rhGM-CSF: 5-7μg/kg daily subcutaneously（sc）without interruption until neutrophils≥1.5×10(9)/L for two continuous days,starting 5 days after transplantation."
849851|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849852|NCT01232504|O2|Outcome|rhG-CSF+ rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
850043|NCT01231607|B1|Baseline|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
849853|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849854|NCT01232504|O3|Outcome|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849855|NCT01232504|O2|Outcome|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849856|NCT01232504|O1|Outcome|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849857|NCT01232504|E3|Reported Event|rhG-CSF Group|subcutaneous rhG-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849858|NCT01232504|E2|Reported Event|rhG-CSF + rhGM-CSF Group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849859|NCT01232504|E1|Reported Event|rhGM-CSF Group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
849860|NCT01232491|B3|Baseline|Total|Total of all reporting groups
849861|NCT01232491|B2|Baseline|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849862|NCT01232491|B1|Baseline|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849863|NCT01232491|P2|Participant Flow|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849864|NCT01232491|P1|Participant Flow|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849865|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849866|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849867|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849868|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849869|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849870|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849934|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
856691|NCT01214174|B4|Baseline|Total|Total of all reporting groups
849871|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849872|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849873|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849874|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
851452|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
849875|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849876|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849877|NCT01232491|O2|Outcome|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849878|NCT01232491|O1|Outcome|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849879|NCT01232491|E2|Reported Event|Control|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects did not receive dietary consultation except for basic dietary advice at baseline. Insulin doses were individually adjusted.
849880|NCT01232491|E1|Reported Event|Dietician|Insulin detemir (Levemir®) 100 U/mL, was injected subcutaneously once daily with the evening meal or at bedtime as add-on to subject's pre-trial treatment of metformin for 26 weeks. Subjects received dietary consultation according to local standard during 3 face-to-face meetings and 3 phone contacts. Insulin doses were individually adjusted.
849881|NCT01232465|B3|Baseline|Total|Total of all reporting groups
849882|NCT01232465|B2|Baseline|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
849883|NCT01232465|B1|Baseline|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
849884|NCT01232465|P2|Participant Flow|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
849885|NCT01232465|P1|Participant Flow|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
849886|NCT01232465|O2|Outcome|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
849887|NCT01232465|O1|Outcome|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
849888|NCT01232465|E2|Reported Event|ICSI|those individuals whose eggs were fertilized via intracytoplasmic sperm injection (ICSI)
849889|NCT01232465|E1|Reported Event|IVF Cycles|those individuals undergoing conventional IVF to inseminate their retrieved eggs
849890|NCT01232296|B3|Baseline|Total|Total of all reporting groups
849891|NCT01232296|B2|Baseline|Sorafenib|400 mg tablet p.o. b.i.d.
849892|NCT01232296|B1|Baseline|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849893|NCT01232296|P2|Participant Flow|Sorafenib|400 mg tablet p.o. b.i.d.
849894|NCT01232296|P1|Participant Flow|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849895|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849896|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849897|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849898|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
849899|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849900|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
849901|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849902|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
849903|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849904|NCT01232296|O2|Outcome|Sorafenib|400 mg tablet p.o. b.i.d.
849905|NCT01232296|O1|Outcome|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849906|NCT01232296|E2|Reported Event|Sorafenib|400 mg tablet p.o. b.i.d.
849907|NCT01232296|E1|Reported Event|TKI258|500 mg capsules p.o. o.d. 5 days on/2 days off
849908|NCT01232283|B3|Baseline|Total|Total of all reporting groups
849909|NCT01232283|B2|Baseline|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo controlled Phase (weeks 0-16).
849910|NCT01232283|B1|Baseline|Apremilast|Participants were initially randomized to Apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
849935|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
849936|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
849911|NCT01232283|P8|Participant Flow|PBO-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to PBO BID during the 16-week Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
849941|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
849942|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
850000|NCT01231984|O1|Outcome|4 mm First|Subjects in this group first used the 4 mm PN for 12 weeks in Period 1, then switched to a longer PN (8 mm or 12 mm PN) for another 12 weeks in Period 2, based on their randomization.
849912|NCT01232283|P7|Participant Flow|APR-APR-APR + Optional Topicals/Phototherapy|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
849913|NCT01232283|P6|Participant Flow|APR-APR Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to APR during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and continued on APR 30 mg BID for the remainder of their participation.
849914|NCT01232283|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost ≥50% PASI improvement achieved at Week 32, were switched back to APR 30 mg BID at the time the loss was observed. Those participants who did not lose at least 50% of the PASI response remained on PBO until Week 52. All participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and received APR 30 mg BID for the remainder of their participation.
849915|NCT01232283|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to PBO BID during the Placebo-controlled Phase (Weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (Weeks 16-32)
849916|NCT01232283|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
849917|NCT01232283|P2|Participant Flow|Placebo|Participants initially randomized to identically matching placebo tablets (PBO) BID during the Placebo controlled Phase (Weeks 0-16)
849918|NCT01232283|P1|Participant Flow|Apremilast|Participants initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
849919|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
849920|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
849921|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
849922|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
849923|NCT01232283|O2|Outcome|APR-APR -Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to APR 30mg BID during the Randomized Withdrawal Phase (Weeks 32-52).
849924|NCT01232283|O1|Outcome|APR-APR Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-50 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who lost ≥50% PASI improvement achieved at Week 32, were switched back to APR 30 mg BID at the time this loss was observed. Those participants who did not lose at least 50% of the PASI response from baseline through the Randomized Withdrawal Phase remained on PBO until Week 52.
849925|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
849926|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
849927|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
849928|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
849929|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
849930|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
849931|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
849932|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
850442|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
849937|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
849938|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
849939|NCT01232283|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets twice daily BID during the Placebo-controlled Phase (weeks 0-16)
849940|NCT01232283|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
850041|NCT01231607|B3|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
849943|NCT01232283|E4|Reported Event|APR-Exposure Period: Weeks 0-52|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0 or at Week 16), up until Week 52. Adverse events associated with 30 mg apremilast treatment up to Week 52 were included.
849944|NCT01232283|E3|Reported Event|APR-APR-PBO: Weeks 32-52|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
849945|NCT01232283|E2|Reported Event|Placebo: Weeks 0-16|Participants randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
849946|NCT01232283|E1|Reported Event|Apremilast: Weeks 0-16|Participants randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
849947|NCT01232205|B3|Baseline|Total|Total of all reporting groups
849948|NCT01232205|B2|Baseline|Control|
849949|NCT01232205|B1|Baseline|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
849950|NCT01232205|P2|Participant Flow|Control|
849951|NCT01232205|P1|Participant Flow|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
849952|NCT01232205|O2|Outcome|Control|
849953|NCT01232205|O1|Outcome|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
849954|NCT01232205|E2|Reported Event|Control|
849955|NCT01232205|E1|Reported Event|Micronutrient Antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
849956|NCT01232127|B1|Baseline|All Treated|
849957|NCT01232127|P3|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849958|NCT01232127|P2|Participant Flow|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849959|NCT01232127|P1|Participant Flow|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI). Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849960|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849961|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849962|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849963|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
849964|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849965|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849966|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849967|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
850443|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
849968|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849969|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus TDF, 300 mg QD, and at least 1 NRTI on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849999|NCT01231984|O2|Outcome|Longer PN First (8mm or 12.7mm)|Subjects in this group first used one of the longer PNs (8 mm or 12 mm PN) for 12 weeks in Period 1, based on the randomization, then switched to the 4mm PN for another 12 weeks in Period 2.
851453|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
849970|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849971|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849972|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI)on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849973|NCT01232127|O1|Outcome|All Treated|All participants who received at least 1 dose of atazanavir with ritonavir and tenofovir and with or without famotidine.
849974|NCT01232127|O3|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849975|NCT01232127|O2|Outcome|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg BID on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849976|NCT01232127|O1|Outcome|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg QD, plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849977|NCT01232127|E3|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (40)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 40 mg BID on Days 18 through 24. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF
849978|NCT01232127|E2|Reported Event|Atazanavir/Ritonavir (400/100) + TDF + ≥NRTI + Famotidine (20)|Participants received atazanavir/ritonavir, 400/100 mg QD, plus TDF, 300 mg QD, plus at least 1 NRTI, plus famotidine, 20 mg twice daily (BID) on Days 11 through 17. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849979|NCT01232127|E1|Reported Event|Atazanavir/Ritonavir (300/100) + TDF + ≥NRTI|Participants received atazanavir/ritonavir, 300/100 mg once daily (QD), plus tenofovir (TDF), 300 mg QD, and at least 1 nucleoside reverse transcriptase inhibitor (NRTI) on Days 1 through 10. Atazanavir/ritonavir and TDF were administered with food. The AM dose of famotidine was administered simultaneously with atazanavir/ritonavir/TDF.
849980|NCT01231984|B3|Baseline|Total|Total of all reporting groups
849981|NCT01231984|B2|Baseline|4 mm vs. 12.7 mm|Subjects randomized to this study arm first use either the 4mm PN or the 12.7mm PN for 12 weeks, then switch to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
849982|NCT01231984|B1|Baseline|4 mm vs. 8 mm|Subjects randomized to this study arm first use either the 4mm PN or the 8mm PN for 12 weeks, then switched to the alternate PN for another 12 weeks. Order of PN use is randomly determined.
849983|NCT01231984|P4|Participant Flow|12.7 mm First ( 4 vs.12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
849984|NCT01231984|P3|Participant Flow|4 mm First (4 vs.12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
849985|NCT01231984|P2|Participant Flow|8 mm First (4 vs.8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
849986|NCT01231984|P1|Participant Flow|4 mm First (4 vs.8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
849987|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
849988|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
849989|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
849990|NCT01231984|O2|Outcome|12.7 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 12.7 mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
849991|NCT01231984|O1|Outcome|4 mm First (4 vs. 12.7)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 12.7 mm PN for the next 12 weeks (Period 2).
849992|NCT01231984|O3|Outcome|12.7mm Needle|Number of subjects enrolled who were assigned to use the 12.7mm PN.
849993|NCT01231984|O2|Outcome|8mm Needle|Number of subjects enrolled who were assigned to use the 8mm PN.
849994|NCT01231984|O1|Outcome|4mm Needle|Number of subjects enrolled who were assigned to use the 4mm PN.
849995|NCT01231984|O2|Outcome|12 mm Among Those in 4 mm x 12 mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 12mm PN for another 12 weeks.
849996|NCT01231984|O1|Outcome|4 mm Among Those in 12mm x 4mm Arm|Subjects randomized to this study arm first used the 12mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
849997|NCT01231984|O2|Outcome|8 mm Among Those in 4mm x 8mm Arm|Subjects randomized to this study arm first used the 4mm PN for 12 weeks, then switched to the 8mm PN for another 12 weeks.
849998|NCT01231984|O1|Outcome|4 mm Among Those in 8mm x 4 mm Arm|Subjects randomized to this study arm first used the 8mm PN for 12 weeks, then switched to the 4mm PN for another 12 weeks.
850042|NCT01231607|B2|Baseline|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
850001|NCT01231984|O2|Outcome|8 mm First (4 vs. 8)|Subjects randomized to this sequence used the 8mm PN for the first 12 weeks (Period 1), then switched to the 4 mm PN for the next 12 weeks (Period 2).
850002|NCT01231984|O1|Outcome|4 mm First (4 vs. 8)|Subjects randomized to this sequence used the 4mm PN for the first 12 weeks (Period 1), then switched to the 8 mm PN for the next 12 weeks (Period 2).
850003|NCT01231984|E3|Reported Event|12.7mm Needle|
850004|NCT01231984|E2|Reported Event|8mm Needle|
850005|NCT01231984|E1|Reported Event|4mm Needle|
850006|NCT01231841|B1|Baseline|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
850007|NCT01231841|P1|Participant Flow|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
850008|NCT01231841|O1|Outcome|Rabbit Antithymocyte Globulin (r-ATG/Thymoglobulin)|Patients received rabbit anti-thymocyte globulin IV daily over 4-24 hours on days 1-5 (3.5 mg/kg/day). Beginning on day 6, patients received oral cyclosporine twice daily (5 mg/kg/day) for a period of 6 months and then tapered.
850009|NCT01231841|E1|Reported Event|rATG|Patients receive anti-thymocyte globulin IV daily over 4-24 hours on days 1-5. Beginning on day 6, patients receive oral cyclosporine twice daily for 6 months followed by a taper. Treatment continues in the absence of disease progression or unacceptable toxicity
850010|NCT01231750|B3|Baseline|Total|Total of all reporting groups
850011|NCT01231750|B2|Baseline|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850012|NCT01231750|B1|Baseline|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850013|NCT01231750|P2|Participant Flow|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850014|NCT01231750|P1|Participant Flow|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850015|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850016|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850017|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850018|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850019|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850020|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850021|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850022|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850023|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850024|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850025|NCT01231750|O2|Outcome|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850026|NCT01231750|O1|Outcome|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850027|NCT01231750|E2|Reported Event|Placebo First, Then 0.1% Capsaicin|"Inactive substance, 4cm spread 8cm x 15cm on skin, once, 45 minutes prior to exercise~Placebo cream : cream, 4cm spread over 8cm x 15cm area of skin"
850028|NCT01231750|E1|Reported Event|0.1% Capsaicin Cream First, Then Placebo|Capsaicin : 0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
850029|NCT01231646|B3|Baseline|Total|Total of all reporting groups
850030|NCT01231646|B2|Baseline|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
850031|NCT01231646|B1|Baseline|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
850032|NCT01231646|P2|Participant Flow|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
850033|NCT01231646|P1|Participant Flow|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
850034|NCT01231646|O2|Outcome|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
850035|NCT01231646|O1|Outcome|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
850036|NCT01231646|E2|Reported Event|Valproate|Women on valproate monotherapy or polytherapy, and had never been exposed to lamotrigine.
850037|NCT01231646|E1|Reported Event|Lamotrigine|Women on lamotrigine monotherapy or polytherapy, and had never been exposed to valproate.
850038|NCT01231607|B6|Baseline|Total|Total of all reporting groups
850039|NCT01231607|B5|Baseline|Placebo|Matching dutasteride placebo and finasteride placebo once daily
850040|NCT01231607|B4|Baseline|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
851454|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
850044|NCT01231607|P5|Participant Flow|Placebo|Matching dutasteride placebo and finasteride placebo once daily
850045|NCT01231607|P4|Participant Flow|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
850046|NCT01231607|P3|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
850047|NCT01231607|P2|Participant Flow|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
850048|NCT01231607|P1|Participant Flow|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
850049|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850050|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850051|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850052|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850053|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850054|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850055|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850056|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850057|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850058|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850059|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850060|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850061|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850062|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850063|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850064|NCT01231607|O3|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850065|NCT01231607|O2|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850066|NCT01231607|O1|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850067|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850068|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850069|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850070|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850071|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850072|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850073|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850444|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
850074|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850075|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850076|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850077|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850078|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850079|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850080|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850081|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850082|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850083|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850084|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850085|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850086|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850087|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850088|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850089|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850090|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850091|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850092|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850093|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850094|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850095|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850096|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850097|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850098|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850099|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850100|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850101|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850102|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850103|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850104|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850105|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850106|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850107|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850108|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850445|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, experimental dose 1.0%
850109|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850110|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850111|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850112|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850113|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850114|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850115|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850116|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850117|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850118|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850119|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850120|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850121|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850122|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850123|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850124|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850125|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850126|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850127|NCT01231607|O5|Outcome|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily by mouth for 24 weeks (6 months). Active comparator was taken either with or without food.
850128|NCT01231607|O4|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850129|NCT01231607|O3|Outcome|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850130|NCT01231607|O2|Outcome|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily by mouth for 24 weeks (6 months). Study treatment was taken either with or without food.
850131|NCT01231607|O1|Outcome|Placebo|Matching dutasteride placebo and finasteride placebo once daily by mouth for 24 weeks (6 months). Placebo treatment was taken either with or without food.
850132|NCT01231607|E5|Reported Event|Placebo|Matching dutasteride placebo and finasteride placebo once daily
850133|NCT01231607|E4|Reported Event|Finasteride 1 mg|Finasteride 1 mg and dutasteride placebo once daily
850134|NCT01231607|E3|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 mg and finasteride placebo once daily
850135|NCT01231607|E2|Reported Event|Dutasteride 0.1 mg|Dutasteride 0.1 mg and finasteride placebo once daily
850136|NCT01231607|E1|Reported Event|Dutasteride 0.02 mg|Dutasteride 0.02 milligrams (mg) and finasteride placebo once daily
850137|NCT01231581|B3|Baseline|Total|Total of all reporting groups
850138|NCT01231581|B2|Baseline|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850139|NCT01231581|B1|Baseline|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850140|NCT01231581|P2|Participant Flow|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850446|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
850447|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
850448|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
850141|NCT01231581|P1|Participant Flow|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850142|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850460|NCT01231334|P2|Participant Flow|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850699|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850143|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850144|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850145|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850146|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850147|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850148|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850149|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850150|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850151|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850152|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850153|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850154|NCT01231581|O2|Outcome|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850867|NCT01229371|E2|Reported Event|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
850155|NCT01231581|O1|Outcome|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850156|NCT01231581|E2|Reported Event|Placebo + Gemcitabine|Participants received placebo orally once daily in combination with 1000 mg/m^2 of gemcitabine given as IV infusion over 30 min. In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until PD, unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850157|NCT01231581|E1|Reported Event|Trametinib + Gemcitabine|Participants received 2 milligrams (mg) trametinib orally once daily in combination with 1000 mg/m^2 of gemcitabine given as intravenous (IV) infusion over 30 minutes (min). In the first cycle, gemcitabine was infused weekly for 7 weeks followed by a week of rest from treatment and then subsequent cycles on Day 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment cycle until progressive disease (PD), unacceptable toxicity, or permanent discontinuation from study treatment for any reason.
850158|NCT01231516|B3|Baseline|Total|Total of all reporting groups
850159|NCT01231516|B2|Baseline|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850160|NCT01231516|B1|Baseline|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850161|NCT01231516|P2|Participant Flow|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850162|NCT01231516|P1|Participant Flow|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850163|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
850164|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850165|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850166|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850167|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850168|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850169|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850170|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850449|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0%: Injection of mid-dose PEM
850450|NCT01231373|O3|Outcome|Polidocanol Injectable Foam, 0.5%|experimental dose polidocanol injectable foam, 0.5%
850171|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850172|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850492|NCT01231230|O3|Outcome|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
850173|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850174|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850175|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850176|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850177|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850178|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850179|NCT01231516|O2|Outcome|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK will continue to supply RAL in the Open-Label Phase until it is commercially available.
850180|NCT01231516|O1|Outcome|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continue to have access to DTG in the Open-Label phase of the study.
850181|NCT01231516|E2|Reported Event|RAL 400 mg BID|Participants received matching DTG placebo OD + RAL 400 mg BID as AM and PM doses + investigator selected background ART therapy for 48 weeks. Participants were discontinued from the study after completion of the Week 48 visit unless a participant successfully completed Week 48 and RAL was not approved and commercially available within the country, GSK continued to supply RAL in the Open-Label Phase until it was commercially available.
850182|NCT01231516|E1|Reported Event|DTG 50 mg OD|Participants received dolutegravir (DTG) 50 milligrams (mg) once daily (OD) + matching Raltegravir (RAL) placebo twice daily (BID), one in the morning (AM dose) and one in the evening (PM dose) + investigator selected background antiretroviral (ART) therapy for 48 weeks. Participants who successfully completed 48 weeks of treatment continued to have access to DTG in the Open-Label phase of the study.
850183|NCT01231503|B9|Baseline|Total|Total of all reporting groups
850184|NCT01231503|B8|Baseline|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850185|NCT01231503|B7|Baseline|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850451|NCT01231373|O2|Outcome|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125%: active placebo for blinding
850452|NCT01231373|O1|Outcome|Vehicle|Vehicle: Injection of vehicle comparator
850186|NCT01231503|B6|Baseline|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850493|NCT01231230|O2|Outcome|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
850187|NCT01231503|B5|Baseline|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850188|NCT01231503|B4|Baseline|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850189|NCT01231503|B3|Baseline|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850190|NCT01231503|B2|Baseline|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850191|NCT01231503|B1|Baseline|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850192|NCT01231503|P8|Participant Flow|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850193|NCT01231503|P7|Participant Flow|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850194|NCT01231503|P6|Participant Flow|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850453|NCT01231373|E4|Reported Event|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam target therapeutic dose
850204|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850195|NCT01231503|P5|Participant Flow|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850196|NCT01231503|P4|Participant Flow|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850197|NCT01231503|P3|Participant Flow|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850198|NCT01231503|P2|Participant Flow|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850199|NCT01231503|P1|Participant Flow|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850200|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850201|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850202|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850203|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850205|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850206|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850207|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850208|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850209|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850210|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850211|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850212|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850454|NCT01231373|E3|Reported Event|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam, 0.5% lower experimental dose
850213|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850214|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850215|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850216|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850217|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850218|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850219|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850220|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850221|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850455|NCT01231373|E2|Reported Event|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam, 0.125% active placebo
850222|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850223|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850224|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850225|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850226|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850227|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850228|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850229|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850230|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850456|NCT01231373|E1|Reported Event|Vehicle|Vehicle: Injection of vehicle comparator
850231|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850232|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850233|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850234|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850235|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850236|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850237|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850238|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850239|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850457|NCT01231334|B3|Baseline|Total|Total of all reporting groups
856692|NCT01214174|B3|Baseline|Dose 3|IBI-10090 1046ug
850249|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850240|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850241|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850242|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850243|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850244|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850245|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850246|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850247|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850248|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
856693|NCT01214174|B2|Baseline|Dose 2|IBI-10090 776ug
850250|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850251|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850252|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850253|NCT01231503|O5|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850254|NCT01231503|O4|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850255|NCT01231503|O3|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850256|NCT01231503|O2|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850257|NCT01231503|O1|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850598|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
850258|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850259|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850260|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850261|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850262|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850263|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850264|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850265|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850266|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850599|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
850267|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850268|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850269|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850270|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850271|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850272|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850273|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850274|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850275|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850868|NCT01229371|E1|Reported Event|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
850276|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850277|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850278|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850279|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850280|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850281|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850282|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of EngerixTM-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850283|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850284|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850600|NCT01230710|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
850294|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850285|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of EngerixTM-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850286|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850287|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850288|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850289|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850290|NCT01231503|O2|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850291|NCT01231503|O1|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850292|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850293|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850601|NCT01230710|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
850295|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850296|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850297|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850298|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850299|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850300|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850301|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850302|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850602|NCT01230502|B4|Baseline|Total|Total of all reporting groups
850869|NCT01229228|B6|Baseline|Total|Total of all reporting groups
850312|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850303|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850304|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850305|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850306|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850307|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850308|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850309|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850310|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850311|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850870|NCT01229228|B5|Baseline|Placebo|
850313|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850314|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850315|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850316|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850317|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850318|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850319|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850320|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850830|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
850871|NCT01229228|B4|Baseline|Naprosyn 500 mg|
850321|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850322|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850323|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850324|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850325|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850326|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850327|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850328|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850329|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850831|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
850832|NCT01229397|O3|Outcome|Inflexal V 0.5 mL x 1|
850348|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850330|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850331|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850332|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850333|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850334|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850335|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850336|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850337|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850338|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850833|NCT01229397|O2|Outcome|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
850339|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850340|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850341|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850342|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850343|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850344|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850345|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850346|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850347|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850834|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
850349|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850350|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850351|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850352|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850353|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850354|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850355|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850356|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850835|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
850872|NCT01229228|B3|Baseline|Naprosyn 250 mg|
850366|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850357|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850358|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850359|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850360|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850361|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850362|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850363|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850364|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850365|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850836|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
850367|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850368|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850369|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850370|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850371|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850372|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850373|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850374|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850837|NCT01229397|E3|Reported Event|Inflexal V 0.5 mL x 1|
850873|NCT01229228|B2|Baseline|Naproxen Test (Upper Dose)|
850384|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850375|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850376|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850377|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850378|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850379|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850380|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850381|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850382|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850383|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850874|NCT01229228|B1|Baseline|Naproxen Test (Lower Dose)|
850385|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850386|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850387|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850388|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850389|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850390|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850391|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850392|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850838|NCT01229397|E2|Reported Event|Inflexal V 0.25 mL x 2 - After 2nd Vaccination|
850393|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850394|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850395|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850396|NCT01231503|O8|Outcome|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850397|NCT01231503|O7|Outcome|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850398|NCT01231503|O6|Outcome|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850399|NCT01231503|O5|Outcome|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850400|NCT01231503|O4|Outcome|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850401|NCT01231503|O3|Outcome|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850839|NCT01229397|E1|Reported Event|Inflexal V 0.25 mL x 2 - After 1st Vaccination|
850840|NCT01229371|B5|Baseline|Total|Total of all reporting groups
850458|NCT01231334|B2|Baseline|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850459|NCT01231334|B1|Baseline|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850494|NCT01231230|O1|Outcome|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
851455|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
850402|NCT01231503|O2|Outcome|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850403|NCT01231503|O1|Outcome|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850404|NCT01231503|E8|Reported Event|Engerix-B Neo Group|Subjects in this group received one dose of Engerix™-B (HBV) ≤ 7 days of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The HBV vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850405|NCT01231503|E7|Reported Event|RTS,S 14-26-9M Group|Subjects received 3 doses of RTS,S/AS01E (or GSK257049) at 14 and 26 weeks of age and at 9 months of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when below ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850406|NCT01231503|E6|Reported Event|RTS,S 10-14-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 10, 14 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850407|NCT01231503|E5|Reported Event|Engerix-B Neo/RTS,S 6-10-26 Group|Subjects received one dose of Engerix™-B (HBV) when ≤ 7 days of age followed by 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E and HBV vaccines were administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850408|NCT01231503|E4|Reported Event|RTS,S 6-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850409|NCT01231503|E3|Reported Event|RTS,S 6-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) at 6, 10 and 14 weeks of age In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850410|NCT01231503|E2|Reported Event|RTS,S Neo-10-26 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 26 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when below ≤ 7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850841|NCT01229371|B4|Baseline|Subjects >60 Years - CSL HA Antigen|
850411|NCT01231503|E1|Reported Event|RTS,S Neo-10-14 Group|Subjects received 3 doses of RTS,S/AS01E (GSK257049) when ≤ 7 days of age and at 10 and 14 weeks of age. In addition, all subjects received a 3-doses course of Tritanrix™HepB/Hib (DTPwHepB/Hib), administered at 6, 10 and 14 weeks of age, one dose of Bacille Calmette Guerin tuberculosis vaccine (BCG), administered when ≤ 7 days of age, 4 doses of Polio Sabin™ (OPV), administered when ≤7 days of age and at 6, 10 and 14 weeks of age, and one dose of Rouvax™ (Measles), administered at 9 months of age. The RTS,S/AS01E vaccine was administered intramuscularly (IM) in the left antero-lateral thigh. The DTPwHepB/Hib and Measles vaccines were administered IM in the right antero-lateral thigh and the OPV vaccine orally. The BCG vaccine was administered via intradermal route in the shoulder.
850412|NCT01231464|B3|Baseline|Total|Total of all reporting groups
850413|NCT01231464|B2|Baseline|Placebo|Matching Vehicle Placebo Nasal Spray QD
850414|NCT01231464|B1|Baseline|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
850415|NCT01231464|P2|Participant Flow|Placebo|Matching Vehicle Placebo Nasal Spray QD
850416|NCT01231464|P1|Participant Flow|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
850417|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
850418|NCT01231464|O1|Outcome|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mg) once daily (QD)
850419|NCT01231464|O2|Outcome|Placebo|Matching Vehicle placebo nasal spray QD
850420|NCT01231464|O1|Outcome|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
850421|NCT01231464|O2|Outcome|Placebo|Matching Vehicle Placebo Nasal Spray QD
850422|NCT01231464|O1|Outcome|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
850423|NCT01231464|E2|Reported Event|Placebo|Matching Vehicle Placebo Nasal Spray QD
850424|NCT01231464|E1|Reported Event|FFNS 110 Mcg|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) once daily (QD)
850425|NCT01231399|B1|Baseline|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
850426|NCT01231399|P1|Participant Flow|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
850427|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
850428|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
850429|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
850430|NCT01231399|O1|Outcome|Dose Level 1 - 2.5 mg Everolimus|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
850431|NCT01231399|E1|Reported Event|Dose Level 1 - 2.5 mg Everolimus Daily|"Patients receive 400 mg/m^2 fluorouracil (5-FU) IV slow push day 1, 2,400 mg/m^2 fluorouracil (5-FU) IV continuously over 46 hours days 1-2, 400 mg/m^2 leucovorin calcium IV over 2 hours, and 85 mg/m^2 oxaliplatin IV over 2 hours on day 1. Patients also receive 2.5 mg oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~oxaliplatin: Given IV~everolimus: Given orally"
850432|NCT01231373|B5|Baseline|Total|Total of all reporting groups
850433|NCT01231373|B4|Baseline|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam therapeutic dose
850434|NCT01231373|B3|Baseline|Polidocanol Injectable Foam, 0.5%|polidocanol injectable foam lower experimental dose
850435|NCT01231373|B2|Baseline|Polidocanol Injectable Foam, 0.125%|polidocanol injectable foam active placebo
850436|NCT01231373|B1|Baseline|Vehicle|Vehicle: Injection of vehicle comparator
850437|NCT01231373|P4|Participant Flow|Polidocanol Injectable Foam, 1.0%|1.0% polidocanol foam injection
850438|NCT01231373|P3|Participant Flow|Polidocanol Injectable Foam, 0.5%|lower experimental polidocanol dose
850439|NCT01231373|P2|Participant Flow|Polidocanol Injectable Foam, 0.125%|active placebo for blinding of therapeutic polidocanol dose
850440|NCT01231373|P1|Participant Flow|Vehicle|Vehicle: Injection of vehicle comparator
850441|NCT01231373|O4|Outcome|Polidocanol Injectable Foam, 1.0%|polidocanol injectable foam, 1.0% experimental dose
850461|NCT01231334|P1|Participant Flow|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850462|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850463|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850464|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850465|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850466|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850467|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850468|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850469|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850470|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850471|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850472|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850473|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850474|NCT01231334|O2|Outcome|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850475|NCT01231334|O1|Outcome|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850476|NCT01231334|E2|Reported Event|Duac® Topical Gel Plus Differin® 0.3% Gel|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
850477|NCT01231334|E1|Reported Event|Aczone® Gel 5% Plus Differin® 0.3% Gel|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks
850478|NCT01231321|B1|Baseline|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
850479|NCT01231321|P1|Participant Flow|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
850480|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
850481|NCT01231321|O2|Outcome|Above Reference Range|Subjects with vital sign values at Week 24 higher than the reference range indicated for each parameter
850482|NCT01231321|O1|Outcome|Below Reference Range|Subjects with vital sign values at Week 24 lower than the reference range indicated for each parameter
850483|NCT01231321|O2|Outcome|Above Reference Range|Subjects with laboratory values at Week 24 higher than the reference range indicated for each parameter
850484|NCT01231321|O1|Outcome|Below Reference Range|Subjects with laboratory values at Week 24 lower than the reference range indicated for each parameter
850485|NCT01231321|O2|Outcome|Change From Abnormal to Normal|Subjects whose physical examination findings for the categories below were abnormal at Baseline and normal at 24 weeks
850486|NCT01231321|O1|Outcome|Change From Normal to Abnormal|Subjects whose physical examination findings for the categories below were normal at Baseline and abnormal at 24 weeks
850487|NCT01231321|O1|Outcome|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
850488|NCT01231321|E1|Reported Event|Adalimumab/ Pre-filled Syringe 40 mg/0.8 mL|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
850489|NCT01231230|B1|Baseline|All Study Participants|participant received in random order one of the four treatments ( fluticasone, salmeterol, fluticasone+salmeterol or placebo)
850490|NCT01231230|P1|Participant Flow|All Study Groups|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
850491|NCT01231230|O4|Outcome|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
851456|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
850495|NCT01231230|E4|Reported Event|Fluticasone/Salmeterol|"inhalation of fluticasone 250mcg combined with salmeterol 50 mcg~fluticasone/salmeterol: inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol"
850496|NCT01231230|E3|Reported Event|Salmeterol|"inhalation of salmeterol 50 mcg once~Salmeterol: 50 mcg salmeterol once~Salmeterol: 50 mcg once"
850497|NCT01231230|E2|Reported Event|Placebo|"inhalation of placebo diskus~placebo inhalation: placebo inhalation once"
850498|NCT01231230|E1|Reported Event|Fluticasone|"inhalation of 250 mcg of fluticasone~fluticasone: 220- mcg once"
850499|NCT01230892|B3|Baseline|Total|Total of all reporting groups
850500|NCT01230892|B2|Baseline|Atenolol|Atenolol: 100 mg PO qday
850501|NCT01230892|B1|Baseline|Nebivolol|Nebivolol: 10 mg PO qday
850502|NCT01230892|P2|Participant Flow|Atenolol|Atenolol: 100 mg PO qday
850503|NCT01230892|P1|Participant Flow|Nebivolol|Nebivolol: 10 mg PO qday
850504|NCT01230892|O2|Outcome|Atenolol|Atenolol: 100 mg PO qday
850505|NCT01230892|O1|Outcome|Nebivolol|Nebivolol: 10 mg PO qday
850506|NCT01230892|E2|Reported Event|Atenolol|Atenolol: 100 mg PO qday
850507|NCT01230892|E1|Reported Event|Nebivolol|Nebivolol: 10 mg PO qday
850508|NCT01230827|B5|Baseline|Total|Total of all reporting groups
850509|NCT01230827|B4|Baseline|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
850510|NCT01230827|B3|Baseline|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
850511|NCT01230827|B2|Baseline|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
850512|NCT01230827|B1|Baseline|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
850513|NCT01230827|P4|Participant Flow|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
850514|NCT01230827|P3|Participant Flow|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
850515|NCT01230827|P2|Participant Flow|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
850516|NCT01230827|P1|Participant Flow|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
850517|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850518|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850519|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850545|NCT01230788|P1|Participant Flow|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
850842|NCT01229371|B3|Baseline|Subjects >60 Years - AdImmune HA Antigen|
850875|NCT01229228|P5|Participant Flow|Placebo|
850520|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850549|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
850698|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
851457|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
850521|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850522|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850523|NCT01230827|O2|Outcome|CNTO 148 (Golimumab)|Participants received golimumab 30 milligram per square meter (mg/m^2) every 4 weeks from Week 0 through Week 12. Participants who had a clinical response at Week 16 and who were randomly allocated to golimumab, received 30 mg/m^2 every 4 weeks through Week 48. Participants continued receiving golimumab 30 mg/m^2 after Week 48 in a long-term extension until Week 248. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850524|NCT01230827|O1|Outcome|Placebo|Participants received golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 12. Participants who had a clinical response to golimumab at Week 16 and were randomly allocated to placebo, received placebo every 4 weeks through Week 48. However, participants receiving placebo and had flare received golimumab 30 mg/m^2 every 4 weeks through Week 48. At Week 48, participants who were receiving placebo not having a clinical remission switched to receive golimumab 30 mg/m^2 in a long-term extension until Week 248 and participants who were receiving placebo and had a clinical remission discontinued from the study. All participants received their fixed dose of commercial methotrexate throughout the study duration.
850525|NCT01230827|E4|Reported Event|Group IV: Golimumab + MTX|Participants were treated with golimumab 30 mg/m^2 through Week 12 and who were treated with golimumab 30 mg/m^2 + MTX at Week 16 and continued on golimumab 30 mg/m^2 + MTX through Week 48.
850526|NCT01230827|E3|Reported Event|Group III: Placebo + MTX -> Golimumab 30 mg/m^2 + MTX|Participants who were treated with golimumab 30 mg/m^2 through Week 12 and were treated with placebo + MTX at Week 16 and switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48. Adverse events are reported for participants who switched to golimumab 30 mg/m^2 + MTX at anytime during the study through Week 48.
850527|NCT01230827|E2|Reported Event|Group II: Placebo Subcutaneously (SC) + MTX|Participants who were treated with golimumab 30 milligram per square meter (mg/m^2) through Week 12 and were treated with placebo + Methotrexate (MTX) at Week 16 and continued on placebo + MTX through Week 48.
850528|NCT01230827|E1|Reported Event|Group I: Participants Who Did Not Enter RW Period|Enrolled participants who did not enter randomized withdrawal (RW) period, including those who discontinued prior Week 16, and those who were non-responders (did not achieve an American College of Rheumatology [ACR] Ped 30 response) at Week 16.
850529|NCT01230814|B3|Baseline|Total|Total of all reporting groups
850530|NCT01230814|B2|Baseline|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
850531|NCT01230814|B1|Baseline|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
850532|NCT01230814|P2|Participant Flow|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
850533|NCT01230814|P1|Participant Flow|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
850534|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
850535|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
850536|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
850537|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
850538|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
850539|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
850540|NCT01230814|O2|Outcome|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
850541|NCT01230814|O1|Outcome|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
850542|NCT01230814|E2|Reported Event|Arm 2: Placebo|Placebo suppositories nightly for five consecutive nights each month.
850543|NCT01230814|E1|Reported Event|Arm 1: Metronidazole Plus Miconazole|Intravaginal metronidazole 750 mg plus miconazole 200 mg (co-formulated suppositories) nightly for 5 consecutive nights each month.
850544|NCT01230788|B1|Baseline|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
850595|NCT01230710|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
850546|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
850547|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
850548|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
851458|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
850550|NCT01230788|O1|Outcome|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
850551|NCT01230788|E1|Reported Event|Rituximab Arm|375 mg/m2/dose on days 8, 15, 22, and 29 diluted in NS to a final concentration of 1 mg/ml for ease of administration. Administer intravenously through a dedicated line.
850552|NCT01230749|B5|Baseline|Total|Total of all reporting groups
850553|NCT01230749|B4|Baseline|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850554|NCT01230749|B3|Baseline|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850555|NCT01230749|B2|Baseline|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850556|NCT01230749|B1|Baseline|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
850557|NCT01230749|P4|Participant Flow|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850558|NCT01230749|P3|Participant Flow|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850559|NCT01230749|P2|Participant Flow|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850560|NCT01230749|P1|Participant Flow|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
850561|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850562|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850563|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850564|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850565|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850566|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850567|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850568|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850569|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850570|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850571|NCT01230749|O3|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850572|NCT01230749|O2|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850573|NCT01230749|O1|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850574|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850575|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850576|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850577|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850578|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850579|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850580|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850581|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850582|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850583|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850584|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850585|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850586|NCT01230749|O4|Outcome|Placebo|Participants received placebo orally, twice a day for 29 days
850587|NCT01230749|O3|Outcome|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850588|NCT01230749|O2|Outcome|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850589|NCT01230749|O1|Outcome|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850590|NCT01230749|E4|Reported Event|JNJ41443532 1000 mg|Participants received JNJ-41443532 1000 mg (4 X 250 mg tablet) orally, twice a day for 29 days.
850591|NCT01230749|E3|Reported Event|JNJ41443532 250 mg|Participants received JNJ-41443532 250 mg tablet orally, twice a day for 29 days.
850592|NCT01230749|E2|Reported Event|Pioglitazone 30 mg|Participants received pioglitazone 30 mg tablet orally, once a day for 29 days.
850593|NCT01230749|E1|Reported Event|Placebo|Participants received placebo tablets orally, twice a day for 29 days.
850594|NCT01230710|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg orally once a day for 48 weeks.
850628|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
850629|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
850630|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
850603|NCT01230502|B3|Baseline|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
850604|NCT01230502|B2|Baseline|Group 2 Donor Specific Regulation DSR +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
850605|NCT01230502|B1|Baseline|Group 3: Donor Specific Regulation DSR -, Standard of Care|"Subjects who test DSR (donor specific regulation) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
850606|NCT01230502|P3|Participant Flow|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
850607|NCT01230502|P2|Participant Flow|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR (donor specific regulation) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
850608|NCT01230502|P1|Participant Flow|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
850609|NCT01230502|O3|Outcome|Group 1 Donor Specific Regulation (DSR) +, MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
850610|NCT01230502|O2|Outcome|Group 2 Donor Specific Regulation (DSR) +; Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
850611|NCT01230502|O1|Outcome|Group 3: Donor Specific Regulation (DSR) -, Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
850843|NCT01229371|B2|Baseline|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
850612|NCT01230502|O3|Outcome|Group 1 DSR (+), Withdrawal of Tacrolimus to MPA Monotherapy|"Subjects that are DSR positive and randomized (1:1)to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
850613|NCT01230502|O2|Outcome|Group 2 DSR (+); Standard of Care|"Subjects that are DSR positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR (+)standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
850614|NCT01230502|O1|Outcome|Group 3: DSR (-), Standard of Care|"Subjects who test DSR negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR (-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
850615|NCT01230502|E3|Reported Event|Group 1 DSR (Donor Specific Regulation) (+),MPA Monotherapy|"Subjects that are Donor specific regulation DSR positive and randomized (1:1) to Group 1 will begin a taper off tacrolimus for 6 months, after repeat DSR testing at 6 months subject will either discontinue tacrolimus if they remain DSR negative or remain at reduced dose if converted to DSR positive~Withdrawal of Tacrolimus to mycophenolate monotherapy: Group 1:~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
850616|NCT01230502|E2|Reported Event|Group 2 DSR (Donor Specific Regulation) (+); Standard of Care|"Subjects that are Donor specific regulation (DSR) positive and randomized (1:1)to Group 2 will remain on standard of care immunosuppression.~data and sample collection: Group 2 : DSR(+) standard of care:~These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
850617|NCT01230502|E1|Reported Event|Group 3: DSR (Donor Specific Regulation) (-), Standard of Care|"Subjects who test Donor specific regulation (DSR) negative will not be randomized to possible tacrolimus withdrawal, and will remain on standard of care immunosuppression.~data and sample collection: Group 3 : DSR(-) standard of care:~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of tacrolimus and mycophenolate sodium with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
850618|NCT01230307|B3|Baseline|Total|Total of all reporting groups
850619|NCT01230307|B2|Baseline|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
850620|NCT01230307|B1|Baseline|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
850621|NCT01230307|P2|Participant Flow|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
850622|NCT01230307|P1|Participant Flow|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
850623|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
850624|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
850625|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
850626|NCT01230307|O1|Outcome|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
850627|NCT01230307|O2|Outcome|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
850876|NCT01229228|P4|Participant Flow|Naprosyn 500 mg|
850631|NCT01230307|E2|Reported Event|Placebo|"A placebo loading dose will be given followed by two placebo tablets daily for 6 months.~Placebo: A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months."
850632|NCT01230307|E1|Reported Event|Vitamin D|"Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months~Vitamin D3: Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months"
850633|NCT01230177|B1|Baseline|Etanercept (Renetical Recombination)|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850634|NCT01230177|P1|Participant Flow|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850635|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850636|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850637|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850638|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850639|NCT01230177|O1|Outcome|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850640|NCT01230177|E1|Reported Event|Etanercept（Genetial Recombination）|Participants in whom the regimen of etanercept was changed from 10 mg twice weekly to 25 mg once weekly for the treatment of rheumatoid arthritis.
850641|NCT01230060|B1|Baseline|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
850642|NCT01230060|P1|Participant Flow|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
850643|NCT01230060|O1|Outcome|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
850644|NCT01230060|E1|Reported Event|enVista|"enVista One-Piece Hydrophobic Acrylic Intraocular Lens~enVista : One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery."
850645|NCT01230021|B1|Baseline|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850646|NCT01230021|P1|Participant Flow|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850647|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850648|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850649|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850650|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850651|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850877|NCT01229228|P3|Participant Flow|Naprosyn 250 mg|
850652|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850653|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850654|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850655|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850656|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850657|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850658|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850659|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850660|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850661|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850662|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850663|NCT01230021|O1|Outcome|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850664|NCT01230021|E1|Reported Event|Recombinant Factor XIII|One single dose of 35 IU/kg rFXIII was administered as an intravenous (i.v.) injection to each child. The trial included one screening visit, one treatment visit (including pharmacokinetics (PK) assessments up to 24 hours) and 4 follow-up visits (at 7, 14, 21 and 30 days after dosing). Blood samples for PK assessments were drawn pre-dose and up to 30 days after dosing.
850844|NCT01229371|B1|Baseline|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
850678|NCT01229891|B4|Baseline|Total|Total of all reporting groups
850679|NCT01229891|B3|Baseline|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
850680|NCT01229891|B2|Baseline|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
850681|NCT01229891|B1|Baseline|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
850682|NCT01229891|P3|Participant Flow|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
850683|NCT01229891|P2|Participant Flow|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
850684|NCT01229891|P1|Participant Flow|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
850685|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850686|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
850687|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850688|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850689|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
850690|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850691|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850692|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
850693|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850694|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850695|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
850696|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850697|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850700|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850701|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
850702|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850703|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850704|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
850705|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850706|NCT01229891|O3|Outcome|Vitamin D-calcium Fortified Yogurt Drink|2 bottle vitamin D-calcium-fortified yogurt drink per day
850707|NCT01229891|O2|Outcome|Vitamin D-fortified Yogurt Drink|2 bottle vitamin D-fortified yogurt drink per day
850708|NCT01229891|O1|Outcome|Plain Yogurt Drink|2 bottle plain yogurt drink per day
850709|NCT01229891|E3|Reported Event|Vitamin D-calcium Yogurt Drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 mL
850710|NCT01229891|E2|Reported Event|Vitamin D-fortified Yogurt Drink|daily intake of two bottle yogurt drink fortified with 500 IU vitamin D/250 mL
850711|NCT01229891|E1|Reported Event|Plain Yogurt Drink|daily intake of two bottle (250 mL) plain yogurt drink
850712|NCT01229735|B3|Baseline|Total Title|
850713|NCT01229735|B2|Baseline|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850714|NCT01229735|B1|Baseline|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850845|NCT01229371|P4|Participant Flow|Subjects >60 Years - CSL HA Antigen|
850715|NCT01229735|P2|Participant Flow|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850716|NCT01229735|P1|Participant Flow|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850717|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850718|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850719|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850720|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850721|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850722|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850723|NCT01229735|O2|Outcome|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850724|NCT01229735|O1|Outcome|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850725|NCT01229735|O2|Outcome|Topiramate (Full Analysis Set)|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850726|NCT01229735|O1|Outcome|Levetiracetam (Full Analysis Set)|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850727|NCT01229735|E2|Reported Event|Topiramate|25 mg and 100 mg topiramate tablet; titration from 100 mg/day (50 mg bid) to 400 mg/day (200 mg bid) topiramate with treatment duration up to 52 weeks
850728|NCT01229735|E1|Reported Event|Levetiracetam|250 mg and 500 mg levetiracetam tablet; titration from 1000 mg/day (500 mg bid) to 3000 mg/day (1500 mg bid) levetiracetam with treatment duration up to 52 weeks
850729|NCT01229722|B3|Baseline|Total|Total of all reporting groups
850730|NCT01229722|B2|Baseline|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
850731|NCT01229722|B1|Baseline|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
850758|NCT01229462|P1|Participant Flow|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
851459|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
850732|NCT01229722|P2|Participant Flow|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
850733|NCT01229722|P1|Participant Flow|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
850734|NCT01229722|O2|Outcome|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
850846|NCT01229371|P3|Participant Flow|Subjects >60 Years - AdImmune HA Antigen|
850847|NCT01229371|P2|Participant Flow|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
850735|NCT01229722|O1|Outcome|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
850736|NCT01229722|E2|Reported Event|Cell Phone|"Participants will receive a text message reminder at scheduled intervals, with varying frequency. They will also be subject to a remote adherence assessment, over text messages, interactive voice response (IVR), or a remote pill count with assistance over the phone from a counselor. Those who demonstrate lower adherence rates may receive a call from a counselor.~ARemind: ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module."
850737|NCT01229722|E1|Reported Event|Beeper|Patients randomized to the control arm (Beeper) will receive the standard of care at each clinic visit. Although the frequency of the study visit is higher than what is observed in standard of care, the subjects will simply asked to bring their HIV medications every 3 weeks (MEMS measure, pill count) and questioned on their adherence to antiretroviral therapy (ART) in the past 7 days. They will not receive any text messages addressing their adherence to ART between each study visit. Their providers will not be receiving any adherence reports but will be asked to assess their adherence at at the start of the trial (Time 1 or T1) and at subsequent clinic visit scheduled according to a frequency defined by standard of care. The decision to restrict the provision of adherence reports to providers and adherence reinforcement messages to intervention group subjects is appropriate, as it is not yet known whether or not the interventions are more effective than the standard of care.
850738|NCT01229527|B4|Baseline|Total|Total of all reporting groups
850739|NCT01229527|B3|Baseline|Meperidine|
850740|NCT01229527|B2|Baseline|Remifentanil RS2|
850741|NCT01229527|B1|Baseline|Remifentanil RS1|
850742|NCT01229527|P3|Participant Flow|Meperidine|
850743|NCT01229527|P2|Participant Flow|Remifentanil RS2|
850744|NCT01229527|P1|Participant Flow|Remifentanil RS1|
850745|NCT01229527|O3|Outcome|Meperidine|
850746|NCT01229527|O2|Outcome|Remifentanil RS2|
850747|NCT01229527|O1|Outcome|Remifentanil RS1|
850748|NCT01229527|O3|Outcome|Meperidine|
850749|NCT01229527|O2|Outcome|Remifentanil RS2|
850750|NCT01229527|O1|Outcome|Remifentanil RS1|
850751|NCT01229527|E3|Reported Event|Meperidine|
850752|NCT01229527|E2|Reported Event|Remifentanil RS2|
850753|NCT01229527|E1|Reported Event|Remifentanil RS1|
850754|NCT01229462|B3|Baseline|Total|Total of all reporting groups
850755|NCT01229462|B2|Baseline|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
850756|NCT01229462|B1|Baseline|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
850757|NCT01229462|P2|Participant Flow|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
850815|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850759|NCT01229462|O2|Outcome|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
850760|NCT01229462|O1|Outcome|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
850761|NCT01229462|E2|Reported Event|Alphagan® and Timolol Concurrent|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) and one drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
850762|NCT01229462|E1|Reported Event|Combigan®|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) and one drop of brimonidine tartrate/timolol fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
850763|NCT01229436|B1|Baseline|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850764|NCT01229436|P1|Participant Flow|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850848|NCT01229371|P1|Participant Flow|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
850849|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
850850|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
850765|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850766|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850767|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850768|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850769|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850770|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850771|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850772|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850773|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850774|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850816|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850775|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850776|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850777|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850778|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850779|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850851|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
850852|NCT01229371|O1|Outcome|Subjects ≥18 to ≤60 Years - AdImmune HA Antigen|
850853|NCT01229371|O4|Outcome|Subjects >60 Years - CSL HA Antigen|
850780|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850781|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850782|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850783|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850784|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850785|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850786|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850787|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850788|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850789|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850790|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850791|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850792|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850793|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850794|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850854|NCT01229371|O3|Outcome|Subjects >60 Years - AdImmune HA Antigen|
850855|NCT01229371|O2|Outcome|Subjects ≥18 to ≤60 Years - CSL HA Antigen|
850878|NCT01229228|P2|Participant Flow|Naproxen Test (Upper Dose)|
850795|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850796|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850797|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850798|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850799|NCT01229436|O1|Outcome|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850800|NCT01229436|E1|Reported Event|Xiapex|A single injection of Xiapex (collagenase clostridium histolyticum) 0.58 milligram (mg) directly into the cord over metacarpophalangeal (MP) joint or proximal interphalangeal (PIP) joint of a finger on injection day followed by a finger extension procedure and 30-day follow-up period in each cycle up to 5 cycles. A maximum of 3 injections were allowed into a single cord. Participants were followed-up at Day 90 and 180 after the last treatment cycle.
850801|NCT01229423|B1|Baseline|LATISSE®|bimatoprost 0.03% (LATISSE®)
850802|NCT01229423|P1|Participant Flow|LATISSE®|bimatoprost 0.03% (LATISSE®)
850803|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
850804|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
850805|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
850806|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
850807|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
850808|NCT01229423|O1|Outcome|LATISSE®|bimatoprost 0.03% (LATISSE®)
850809|NCT01229423|E1|Reported Event|LATISSE®|bimatoprost 0.03% (LATISSE®)
850810|NCT01229410|B3|Baseline|Total|Total of all reporting groups
850811|NCT01229410|B2|Baseline|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850812|NCT01229410|B1|Baseline|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850813|NCT01229410|P2|Participant Flow|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850814|NCT01229410|P1|Participant Flow|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850920|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850817|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850818|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850819|NCT01229410|O2|Outcome|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850820|NCT01229410|O1|Outcome|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850821|NCT01229410|E2|Reported Event|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850822|NCT01229410|E1|Reported Event|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
850823|NCT01229397|B3|Baseline|Total|Total of all reporting groups
850824|NCT01229397|B2|Baseline|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
850825|NCT01229397|B1|Baseline|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
850826|NCT01229397|P2|Participant Flow|Inflexal V 0.5 mL x 1|"1 dose of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, containing per 0.5 mL dose:~15 μg HA antigen of A/California/7/2009 (H1N1)-like virus~15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~15 μg HA antigen of B/Brisbane/60/2008-like virus"
850827|NCT01229397|P1|Participant Flow|Inflexal V 0.25 mL x 2|"2 doses of Inflexal V influenza vaccine (surface antigen, inactivated, virosome) 2010/2011, 4 weeks apart, containing per 0.25 mL dose:~7.5 μg HA antigen of A/California/7/2009 (H1N1)-like virus~7.5 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus~7.5 μg HA antigen of B/Brisbane/60/2008-like virus"
850828|NCT01229397|O2|Outcome|Inflexal V 0.5 mL x 1|One 0.5 mL dose (on Day 1)
850829|NCT01229397|O1|Outcome|Inflexal V 0.25 mL x 2|Two 0.25 mL doses (on Day 1 and 29)
850883|NCT01229228|O2|Outcome|Naproxen Test (Upper Dose)|400-mg (2 x 200-mg)
850884|NCT01229228|O1|Outcome|Naproxen Test (Lower Dose)|200-mg single dose
850885|NCT01229228|E5|Reported Event|Placebo|
850886|NCT01229228|E4|Reported Event|Naprosyn 500 mg|
850887|NCT01229228|E3|Reported Event|Naprosyn 250 mg|
850888|NCT01229228|E2|Reported Event|Naproxen Test (Upper Dose)|
850889|NCT01229228|E1|Reported Event|Naproxen Test (Lower Dose)|
850890|NCT01229176|B9|Baseline|Total|Total of all reporting groups
850891|NCT01229176|B8|Baseline|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850892|NCT01229176|B7|Baseline|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850893|NCT01229176|B6|Baseline|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850894|NCT01229176|B5|Baseline|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850895|NCT01229176|B4|Baseline|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
850896|NCT01229176|B3|Baseline|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850897|NCT01229176|B2|Baseline|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850898|NCT01229176|B1|Baseline|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850899|NCT01229176|P8|Participant Flow|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850900|NCT01229176|P7|Participant Flow|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850901|NCT01229176|P6|Participant Flow|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850902|NCT01229176|P5|Participant Flow|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850903|NCT01229176|P4|Participant Flow|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
850904|NCT01229176|P3|Participant Flow|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850905|NCT01229176|P2|Participant Flow|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850906|NCT01229176|P1|Participant Flow|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850907|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850908|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850909|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850910|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850911|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
850912|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850913|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850914|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850915|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850916|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850917|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850918|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850919|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
851460|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
850921|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850922|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850923|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850924|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850925|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850926|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850927|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
850928|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850929|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850930|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850931|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850932|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850933|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850934|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850935|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
850936|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850937|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850938|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850939|NCT01229176|O8|Outcome|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850940|NCT01229176|O7|Outcome|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850941|NCT01229176|O6|Outcome|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850942|NCT01229176|O5|Outcome|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850943|NCT01229176|O4|Outcome|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
850944|NCT01229176|O3|Outcome|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850945|NCT01229176|O2|Outcome|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850946|NCT01229176|O1|Outcome|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850947|NCT01229176|E8|Reported Event|PNC13, Infants|Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
850948|NCT01229176|E7|Reported Event|Vi-CRM, Infants|Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
850949|NCT01229176|E6|Reported Event|PNC13, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
850950|NCT01229176|E5|Reported Event|Vi-CRM, Older Infants|Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850951|NCT01229176|E4|Reported Event|Vi-PS, Children|Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
850952|NCT01229176|E3|Reported Event|Vi-CRM, Children|Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
850953|NCT01229176|E2|Reported Event|Vi-PS, Adults|Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
850954|NCT01229176|E1|Reported Event|Vi-CRM, Adults|Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
850955|NCT01229150|B5|Baseline|Total|Total of all reporting groups
850956|NCT01229150|B4|Baseline|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850957|NCT01229150|B3|Baseline|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
850958|NCT01229150|B2|Baseline|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850959|NCT01229150|B1|Baseline|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850960|NCT01229150|P4|Participant Flow|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850961|NCT01229150|P3|Participant Flow|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
850962|NCT01229150|P2|Participant Flow|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850963|NCT01229150|P1|Participant Flow|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850964|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
851461|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
850965|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
850966|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850967|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850968|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
850969|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd (every day)"
850970|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850971|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd."
850972|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850973|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
850974|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850975|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850976|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850977|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850978|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850979|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850980|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850981|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850982|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850983|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850984|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850985|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850986|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850987|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850988|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850989|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
850990|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850991|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850992|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850993|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850994|NCT01229150|O3|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850995|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
850996|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
850997|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
850998|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
850999|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
851000|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
851001|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
856694|NCT01214174|B1|Baseline|Dose 1|IBI-10090 513ug
851002|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
851003|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
851004|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
851005|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
851006|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
851007|NCT01229150|O1|Outcome|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
851008|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
851009|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
851010|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
851011|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
851012|NCT01229150|O4|Outcome|WT KRAS 2|"Wild-Type KRAS patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd + erl mg qd."
851013|NCT01229150|O3|Outcome|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
851014|NCT01229150|O2|Outcome|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
851015|NCT01229150|O1|Outcome|KRAS Mut 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
851016|NCT01229150|E3|Reported Event|WT KRAS 1|"Wild-Type KRAS patients randomized to monotherapy arm~Erlotinib: For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd"
851017|NCT01229150|E2|Reported Event|KRAS Mut 1|"KRAS Mutant patients randomized to monotherapy arm~AZD6244: For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day)."
851018|NCT01229150|E1|Reported Event|KRAS Mut 2 & WT KRAS 2|"KRAS Mutant patients randomized to combination therapy arm~AZD6244 + Erlotinib: For KRAS mutant patients and Wild-Type KRAS 2 patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erlotinib mg qd."
851019|NCT01229111|B1|Baseline|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851127|NCT01228175|B2|Baseline|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
851020|NCT01229111|P1|Participant Flow|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851021|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851022|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851023|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851024|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851025|NCT01229111|O1|Outcome|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851026|NCT01229111|E1|Reported Event|Treatment (Cediranib Maleate and Modified FOLFOX)|"Patients receive cediranib maleate PO QD on days 1-14 and modified FOLFOX6 comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46 hours on day 1.~cediranib maleate: Given PO~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
851215|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851027|NCT01228968|B1|Baseline|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
851028|NCT01228968|P1|Participant Flow|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
851029|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
851030|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
851031|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
851032|NCT01228968|O1|Outcome|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
851033|NCT01228968|E1|Reported Event|Volunteers|Volunteers will have a range of body mass index from 19 - 45 kilogram per square meter. In order to fit in the magnetic resonance scanner subjects must weigh less than 300 pounds.
851034|NCT01228929|B4|Baseline|Total|Total of all reporting groups
851035|NCT01228929|B3|Baseline|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
851036|NCT01228929|B2|Baseline|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
851037|NCT01228929|B1|Baseline|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
851038|NCT01228929|P3|Participant Flow|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
851039|NCT01228929|P2|Participant Flow|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
851040|NCT01228929|P1|Participant Flow|Normal|Subjects with no clinical diagnosis or symptoms of dry eye. Each participant completed 3 environmental conditions. Nominal is 75 degrees F and 40% relative humidity. Low humidity is 20% relative humidity and 75 degrees F. High temperature is 85 degrees F and 40% relative humidity.
851041|NCT01228929|O3|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
851042|NCT01228929|O2|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
851043|NCT01228929|O1|Outcome|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
851044|NCT01228929|E3|Reported Event|Meibomian Gland Dysfunction (MGD)|Subjects having mild to moderate Meibomian Gland Dysfunction by slit lamp evaluation.
851045|NCT01228929|E2|Reported Event|Aqueous Deficiency Dry Eye (ADDE)|Subjects with low tear volume measured by Schirmer's test less than 10 mm.
851046|NCT01228929|E1|Reported Event|Normal|Subjects with no clinical diagnosis or symptoms of dry eye.
851047|NCT01228903|B3|Baseline|Total|Total of all reporting groups
851048|NCT01228903|B2|Baseline|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
851462|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851049|NCT01228903|B1|Baseline|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
851050|NCT01228903|P2|Participant Flow|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
851051|NCT01228903|P1|Participant Flow|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
851052|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
851053|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
851054|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
851055|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
851056|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
851057|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
851058|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
851059|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
851060|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
851061|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
851062|NCT01228903|O2|Outcome|Allopurinol|Allopurinol: Xanthine oxidase inhibitor
851063|NCT01228903|O1|Outcome|Control|Placebo: Placebo tablets with no active ingredient
851064|NCT01228903|E2|Reported Event|Allopurinol|"Patients who are randomized to this group will receive allopurinol tablets. Allopurinol is a medicine that lowers uric acid levels. The effects of lowering uric acid on vascular function outcomes will be assessed and compared to the control group.~Allopurinol: Xanthine oxidase inhibitor- effective at lowering uric acid levels."
851216|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
856695|NCT01214174|P3|Participant Flow|Dose 3|IBI-10090 1046ug
851065|NCT01228903|E1|Reported Event|Control|"Patients who are randomized to this group will received placebo tablets. Placebo tables do not contain an active ingredient. This group will be used as a baseline group to compare the effects of lowering uric acid on vascular function.~Placebo: Placebo tablets with no active ingredient"
851066|NCT01228747|B3|Baseline|Total|Total of all reporting groups
851067|NCT01228747|B2|Baseline|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851068|NCT01228747|B1|Baseline|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily"
851069|NCT01228747|P2|Participant Flow|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851070|NCT01228747|P1|Participant Flow|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
851071|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851072|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
851073|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851074|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
851075|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851076|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
851077|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851078|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
851079|NCT01228747|O2|Outcome|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851080|NCT01228747|O1|Outcome|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
851081|NCT01228747|E2|Reported Event|Levetiracetam|"Levetiracetam treatment with dosing of 1000 mg/day or 2000 mg/day or 3000 mg/day for 28 weeks~Levetiracetam: Oral dose tablets, twice daily"
851082|NCT01228747|E1|Reported Event|Placebo|"Matching placebo for 28 weeks~Placebo: Matching oral placebo tablets twice daily for 28 weeks"
851083|NCT01228734|B3|Baseline|Total|Total of all reporting groups
851084|NCT01228734|B2|Baseline|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851094|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851085|NCT01228734|B1|Baseline|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851086|NCT01228734|P2|Participant Flow|FOLFOX4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851087|NCT01228734|P1|Participant Flow|Cetuximab + FOLFOX4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-fluorouracil (5-FU)/folinic acid (FA). Cetuximab was always administered every 7 days with an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851088|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851141|NCT01228149|O1|Outcome|Diamox/DexaEDO|"Patients receive oral Diamox (acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851142|NCT01228149|E2|Reported Event|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851089|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851090|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851091|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851092|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851093|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851126|NCT01228175|B3|Baseline|Total|Total of all reporting groups
851095|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851096|NCT01228734|O2|Outcome|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851097|NCT01228734|O1|Outcome|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851098|NCT01228734|E2|Reported Event|FOLFOX-4|Subjects received FOLFOX-4 chemotherapy regimen that consists of a combination of oxaliplatin with 5-FU/FA. Oxaliplatin 85 mg/m^2 infused over 120 minutes was administered first or simultaneously with FA at a dose of 200 mg/m^2 infused over 120 minutes on Day 1, Day 2, and every 2 weeks and then 5-FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851276|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851099|NCT01228734|E1|Reported Event|Cetuximab + FOLFOX-4|Subjects received cetuximab in combination with FOLFOX-4 chemotherapy regimen. FOLFOX-4 chemotherapy regimen consists of a combination of oxaliplatin with 5-FU/FA. Cetuximab was always administered every 7 days with an initial dose of 400 mg/m^2 at 5 mg/min and 250 mg/m^2 at 10 mg/min for subsequent infusions, followed by oxaliplatin 85 mg/m^2 infused over 120 minutes at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin, FA was administered at a dose of 200 mg/m^2 infused over 120 minutes, on Day 1, Day 2, and every 2 weeks and then 5- FU was administered as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infused over 22 hours, on Day 1, Day 2, and every 2 weeks. All subjects received treatment until progression of disease, withdrawal of consent, or unacceptable toxicity.
851100|NCT01228591|B1|Baseline|All Subjects|Subjects who were randomized and successfully completed the study.
851101|NCT01228591|P2|Participant Flow|Acuvue Advance/ Acuvue Advance Plus|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
851102|NCT01228591|P1|Participant Flow|Acuvue Advance Plus/ Acuvue Advance|Group 1 wore AAP first and AA second. Group 2 wore AA first and AAP second
851103|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
851104|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
851105|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
851106|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
851107|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
851108|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
851109|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn.
851110|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn.
851111|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses worn
851112|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses worn
851113|NCT01228591|O2|Outcome|Acuvue Advance|Acuvue Advance contact lenses - Binocular Measurements
851114|NCT01228591|O1|Outcome|Acuvue Advance Plus|Acuvue Advance Plus contact lenses-Binocular measurements
851115|NCT01228591|E2|Reported Event|Acuvue Advance|Acuvue Advance contact lenses
851116|NCT01228591|E1|Reported Event|Acuvue Advance Plus|Acuvue Advance Plus contact lenses
851117|NCT01228435|B3|Baseline|Total|Total of all reporting groups
851118|NCT01228435|B2|Baseline|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
851119|NCT01228435|B1|Baseline|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
851120|NCT01228435|P2|Participant Flow|ALK-inhibitor Pre-treated|Patients in this arm had prior exposure to an ALK inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
851121|NCT01228435|P1|Participant Flow|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225 mg/m2 twice a week for 2 weeks followed by 10 days off therapy, cycles repeated every 21 days.
851122|NCT01228435|O2|Outcome|ALK-inhibitor Pre-treated|Patients in this arm had receieved prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
851123|NCT01228435|O1|Outcome|ALK-inhibitor Naive|Patients in this arm has no prior exposure to ALK-inhibitor and were treated with IPI-504 at 225mg/m2 twice a week for 2 weeks followed by 10 days off with cycles repeating every 21 days.
851124|NCT01228435|E2|Reported Event|ALK-inhibitor Pre-treated|Prior exposure to ALK inhibitor
851125|NCT01228435|E1|Reported Event|ALK-inhibitor Naive|No prior exposure to ALK-inhibitor
851128|NCT01228175|B1|Baseline|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
851129|NCT01228175|P2|Participant Flow|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
851130|NCT01228175|P1|Participant Flow|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
851131|NCT01228175|O2|Outcome|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
851132|NCT01228175|O1|Outcome|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
851133|NCT01228175|E2|Reported Event|Microcrystal Cellulose|"Microcrystal cellulose placebo~Placebo: 25mg look alike riboflavin tablets to match active study medication."
851134|NCT01228175|E1|Reported Event|Varenicline|"Varenicline~Varenicline: Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily"
851135|NCT01228149|B3|Baseline|Total|Total of all reporting groups
851136|NCT01228149|B2|Baseline|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851137|NCT01228149|B1|Baseline|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851138|NCT01228149|P2|Participant Flow|Cosopt S|"Patients receive Cosopt S eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851139|NCT01228149|P1|Participant Flow|Diamox/DexaEDO|"Patients receive oral acetazolamide starting 28 days preoperatively. 7 days preoperatively dexamethasone eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851140|NCT01228149|O2|Outcome|Cosopt S|"Patients receive Cosopt S (dorzolamide/timolol) eye drops starting 28 days preoperatively~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851214|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851143|NCT01228149|E1|Reported Event|Diamox/DexaEDO|"Patients receive Diamox (oral acetazolamide) starting 28 days preoperatively. 7 days preoperatively DexaEDO (dexamethasone) eyedrops without preservatives are applied additionally.~Trabeculectomy: Filtrating glaucoma surgery, preoperative treatment will be assessed."
851144|NCT01228084|B1|Baseline|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851145|NCT01228084|P1|Participant Flow|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851146|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851147|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851148|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851149|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851150|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851151|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851152|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851153|NCT01228084|O1|Outcome|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
851154|NCT01228084|E1|Reported Event|Sulpforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic
851155|NCT01228071|B1|Baseline|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
851156|NCT01228071|P1|Participant Flow|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
851157|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
851158|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
851159|NCT01228071|O1|Outcome|40 mg Daily Dose of Testosterone Gel 2%|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
851160|NCT01228071|E1|Reported Event|EN3350 (Testosterone Gel 2%)|"testosterone gel 2%~testosterone gel 2% : 40 mg testosterone gel 2%"
851161|NCT01228019|B1|Baseline|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851162|NCT01228019|P1|Participant Flow|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851163|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851164|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851165|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851166|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851167|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851168|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851169|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851170|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851171|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851172|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851173|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851174|NCT01228019|O1|Outcome|All Participants|Participants with primary hypercholesterolemia or mixed dyslipidemia treated with niacin (+) laropiprant (TREDAPTIVE)
851175|NCT01228019|E1|Reported Event|ALL PARTICIPANTS|
851176|NCT01227993|B1|Baseline|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851177|NCT01227993|P1|Participant Flow|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851178|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851179|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851180|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851181|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851182|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851183|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851184|NCT01227993|O1|Outcome|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851185|NCT01227993|E1|Reported Event|Finasteride|Participants are treated with 5 mg oral finasteride daily when they have clinically significant subretinal fluid accumulation, defined as any subretinal fluid in the macula with a volume of at least 0.1 microliter and causing visual change such as reduced acuity, metamorphopsia, or microperimetry deficits.
851186|NCT01227980|B3|Baseline|Total|Total of all reporting groups
851187|NCT01227980|B2|Baseline|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851188|NCT01227980|B1|Baseline|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851189|NCT01227980|P2|Participant Flow|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851190|NCT01227980|P1|Participant Flow|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851191|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851192|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851193|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851194|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851195|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851463|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851196|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851197|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851198|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851199|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851200|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851201|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851202|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851203|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851204|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851205|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851206|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851207|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851208|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851209|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851210|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851211|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851212|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851213|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
856696|NCT01214174|P2|Participant Flow|Dose 2|IBI-10090 776ug
851217|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851218|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851219|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851220|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851221|NCT01227980|O2|Outcome|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851222|NCT01227980|O1|Outcome|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851223|NCT01227980|E2|Reported Event|Placebo|Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
851224|NCT01227980|E1|Reported Event|Pexacerfont|Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days
851225|NCT01227928|B3|Baseline|Total|Total of all reporting groups
851226|NCT01227928|B2|Baseline|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851227|NCT01227928|B1|Baseline|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851228|NCT01227928|P2|Participant Flow|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851229|NCT01227928|P1|Participant Flow|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851230|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851231|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851232|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851233|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851234|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851235|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851236|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851237|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851238|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851239|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851240|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851241|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851242|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851243|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851244|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851245|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851246|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851247|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851248|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851249|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851250|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851251|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851252|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851253|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851254|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851255|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851256|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851257|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851258|NCT01227928|O2|Outcome|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851259|NCT01227928|O1|Outcome|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851260|NCT01227928|E2|Reported Event|Pazopanib 800 Milligrams|Participants received pazopanib 800 milligrams administered orally once daily for up to 24 months.
851261|NCT01227928|E1|Reported Event|Placebo|Participants received matching placebo administered orally once daily for up to 24 months.
851262|NCT01227902|B5|Baseline|Total|Total of all reporting groups
851409|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
856697|NCT01214174|P1|Participant Flow|Dose 1|IBI-10090 513ug
851263|NCT01227902|B4|Baseline|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851264|NCT01227902|B3|Baseline|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851265|NCT01227902|B2|Baseline|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851266|NCT01227902|B1|Baseline|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851267|NCT01227902|P4|Participant Flow|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851268|NCT01227902|P3|Participant Flow|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851269|NCT01227902|P2|Participant Flow|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851464|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851465|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851466|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851467|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851270|NCT01227902|P1|Participant Flow|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851271|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851272|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851273|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851274|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851275|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851277|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851278|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851279|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851280|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851281|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851282|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851283|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851376|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851284|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851285|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851286|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851287|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851288|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851289|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851304|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851290|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851291|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851292|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851293|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851294|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851295|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851296|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851419|NCT01227824|E1|Reported Event|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851297|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851298|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851299|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851300|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851301|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851302|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851303|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851360|NCT01227889|B3|Baseline|Total|Total of all reporting groups
851410|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851485|NCT01227785|E1|Reported Event|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
851305|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851306|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851307|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851308|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851309|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851310|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851311|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851312|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851313|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851314|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851315|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851316|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851317|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851318|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851405|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851319|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851320|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851321|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851322|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851323|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851324|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851420|NCT01227785|B1|Baseline|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
851421|NCT01227785|P1|Participant Flow|INCEPTA ICD and CRT-D|Patients implanted with Incepta ICD or CRT-D device
851325|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851326|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851327|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851328|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851329|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851330|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851331|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851332|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851406|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851482|NCT01227785|O2|Outcome|Group 2: Patients Without a HFE|Patients who did not experience a protocol-defined HFE
851580|NCT01227629|O8|Outcome|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
851333|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851334|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851335|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851336|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851337|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851338|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851339|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851340|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851341|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851342|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851343|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851344|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851345|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851346|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851407|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851347|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851348|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851349|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851350|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851351|NCT01227902|O5|Outcome|Total|All four antiepileptic drug treatment arms combined
851352|NCT01227902|O4|Outcome|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851353|NCT01227902|O3|Outcome|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851354|NCT01227902|O2|Outcome|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851355|NCT01227902|O1|Outcome|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851356|NCT01227902|E4|Reported Event|RTG Flexible Dose Plus Valproic Acid|Along with concurrent valproic acid, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851357|NCT01227902|E3|Reported Event|RTG Flexible Dose Plus Levetiracetam|Along with concurrent leveteracetam, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851358|NCT01227902|E2|Reported Event|RTG Flexible Dose Plus Lamotrigine|Along with concurrent lamotrigine, participants initiated treatment with RTG IR at 150 mg/day (50 mg TID) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851359|NCT01227902|E1|Reported Event|RTG Flexible Dose Plus C/O|Along with concurrent carbamazepine/oxcarbazepine (C/O), participants initiated treatment with retigabine (RTG) immediate release (IR) at 150 milligrams per day (mg/day) (50 mg thrice a day [TID]) and titrated to 600 mg/day (200 mg/day TID) over a 4-week Titration Phase. This was followed by a 16-week Flexible Dose Evaluation Phase, during which the dose could be increased or decreased on a weekly basis between 50 and 150 mg/day, depending on efficacy and tolerability, with the total dose staying between 300 and 1200 mg/day. Participants who were unable to tolerate a minimum dose of 300 mg/day were discontinued from the study.
851361|NCT01227889|B2|Baseline|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
851362|NCT01227889|B1|Baseline|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851363|NCT01227889|P2|Participant Flow|DTIC 1000 mg/m^2 in RP; GSK2118436 in Crossover Phase|In the RP, par. received intravenous (IV) Dacarbazine (DTIC) 1000 mg per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Par. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Par. who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Par. who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover par. continued on GSK2118436 until further DP was noted. After DP on GSK2118436, par. were followed for response, progression, survival, and further anti-cancer therapy.
851422|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD (Overall Study Population)|
851423|NCT01227785|O2|Outcome|INCEPTA ICD|
851424|NCT01227785|O1|Outcome|INCEPTA CRT-D|
851425|NCT01227785|O2|Outcome|INCEPTA ICD|
851426|NCT01227785|O1|Outcome|INCEPTA CRT-D|
851427|NCT01227785|O2|Outcome|INCEPTA ICD|
851428|NCT01227785|O1|Outcome|INCEPTA CRT-D|
851364|NCT01227889|P1|Participant Flow|GSK2118436 150 mg BID|Participants (par.) were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851365|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851366|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851367|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851368|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851369|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
851370|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
851371|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851372|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851373|NCT01227889|O1|Outcome|GSK25118436 in Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
851374|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851375|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851429|NCT01227785|O2|Outcome|INCEPTA ICD|
851430|NCT01227785|O1|Outcome|INCEPTA CRT-D|
851431|NCT01227785|O2|Outcome|INCEPTA ICD|
851432|NCT01227785|O1|Outcome|INCEPTA CRT-D|
851377|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851378|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851379|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851380|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851381|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease DP, death, the occurrence of an unacceptable adverse AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851382|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851383|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851408|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851483|NCT01227785|O1|Outcome|Group1: Patients With a HFE|Patients who experienced a protocol-defined HF event
851384|NCT01227889|O2|Outcome|DTIC 1000 mg/m^2 in RP|In the RP, participants received intravenous (IV) Dacarbazine (DTIC) 1000 milligrams per meters squared (mg/m^2) every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851385|NCT01227889|O1|Outcome|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 milligrams (mg) twice a day (BID). Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until disease progression (DP), death, the occurrence of an unacceptable adverse event (AE), or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851386|NCT01227889|E3|Reported Event|GSK25118436 in the Crossover Phase|Participants who received DTIC in the RP and experienced DP had the option, at the discretion of the Investigator, of receiving GSK2118436 150 mg BID in the Crossover Phase. Participants who permanently discontinued DTIC treatment due to an AE, withdrawal of consent, or for any reason other than DP were not eligible for crossover to GSK2118436. Crossover participants continued on GSK2118436 until further DP was noted. After DP on GSK2118436, participants were followed for response, progression, survival, and further anti-cancer therapy.
851387|NCT01227889|E2|Reported Event|DTIC 1000 mg/m^2 in RP|In the RP, participants received IV DTIC 1000 mg/m^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
851433|NCT01227785|O2|Outcome|INCEPTA ICD|
851434|NCT01227785|O1|Outcome|INCEPTA CRT-D|
851435|NCT01227785|O2|Outcome|INCEPTA ICD|
851436|NCT01227785|O1|Outcome|INCEPTA CRT-D|
851437|NCT01227785|O1|Outcome|INCEPTA CRT-D and ICD Patients (Overall Study Population)|
851438|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851439|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851388|NCT01227889|E1|Reported Event|GSK2118436 150 mg BID|Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
851389|NCT01227824|B3|Baseline|Total|Total of all reporting groups
851390|NCT01227824|B2|Baseline|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851391|NCT01227824|B1|Baseline|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851392|NCT01227824|P2|Participant Flow|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851393|NCT01227824|P1|Participant Flow|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851394|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851395|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851396|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851397|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851398|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851399|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851400|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851401|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851402|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851403|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851404|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851411|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851412|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851413|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851414|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851415|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851416|NCT01227824|O2|Outcome|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851417|NCT01227824|O1|Outcome|DTG 50 mg OD|Participants received Dolutegravir (DTG) 50 milligrams (mg) once a day (OD) in combination with Nonnucleoside Reverse Transcriptase Inhibitor (NRTI) therapy, either with Abacavir (ABC)/Lamivudine (3TC) or Tenofovir (TDF)/Emtricitabine (FTC). Participants were given the opportunity to receive DTG 50 mg OD during an Open-label Phase of the study.
851418|NCT01227824|E2|Reported Event|RTG 400 mg BID|Participants received Raltegravir (RTG) 400 mg twice a day (BID) in combination with NRTI therapy, either with ABC/3TC or TDF/FTC.
851440|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851468|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851469|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851470|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851471|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851472|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851473|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851474|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851475|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851476|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851477|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851478|NCT01227785|O2|Outcome|INCEPTA ICD Patients|
851479|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851480|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851481|NCT01227785|O1|Outcome|INCEPTA CRT-D Patients|
851486|NCT01227707|B1|Baseline|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851487|NCT01227707|P1|Participant Flow|Bevacizumab (Bv)+Capecitabine/Bv+Leucovorin+5-fluorouracil|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days -14, 1, 15, and 29 and capecitabine 825 milligrams per square meter (mg/m^2) orally (PO) twice daily (BID) from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gray (Gy) administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851488|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851489|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851490|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851491|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851492|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851493|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851513|NCT01227668|B1|Baseline|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
851514|NCT01227668|P2|Participant Flow|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
851569|NCT01227629|P2|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851494|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851495|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851581|NCT01227629|O7|Outcome|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
851582|NCT01227629|O6|Outcome|D150qd|Dabigatran 150 mg once daily
851496|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851497|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851498|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851499|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851500|NCT01227707|O1|Outcome|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851501|NCT01227707|E1|Reported Event|Bv+Capecitabine/Bv+Leucovorin+5-FU|Participants received bevacizumab 5 mg/kg IV on Days -14, 1, 15, and 29 and capecitabine 825 mg/m^2 PO BID from Days 1 to 38. Participants also received radiation therapy given at a daily fraction of 1.8 Gy administered in 5 weekly fractions starting at Week 1 (through Week 6) for a maximum total dose of 45 Gy. Six to 8 weeks following all above treatments, participants received complete mesorectal excision surgery. After surgery, participants received bevacizumab 5 mg/kg IV on Day 1 and leucovorin 100 mg/m^2 IV (over 2 hours) followed by 5-FU 400 mg/m^2 IV bolus and then 5-FU 600 mg/m^2 IV (over 22 hours) on Days 1 and 2 every 2 weeks for a maximum of 12 cycles.
851502|NCT01227681|B4|Baseline|Total|Total of all reporting groups
851503|NCT01227681|B3|Baseline|Placebo|normal saline 0.9% injection
851504|NCT01227681|B2|Baseline|Low Dose G-CSF Injection for Parkinson's Disease|1.65 ug/kg/day for consecutive 5 days of each 60 day cycle
851505|NCT01227681|B1|Baseline|High Dose G-CSF Injection for Parkinson's Disease|3.3 ug/kg/day for consecutive 5 days of each 60 day cycle
851506|NCT01227681|P3|Participant Flow|Placebo|subcutaneous Normal saline for consecutive 5 days of each 60 day cycle
851507|NCT01227681|P2|Participant Flow|Low Dose G-CSF|1.65ug/kg/day for consecutive 5 days of each 60 day cycle
851508|NCT01227681|P1|Participant Flow|G-CSF|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
851509|NCT01227681|O1|Outcome|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
851510|NCT01227681|E1|Reported Event|G-CSF Injection for Parkinson's Disease|3.3ug/kg/day for consecutive 5 days of each 60 day cycle
851511|NCT01227668|B3|Baseline|Total|Total of all reporting groups
851512|NCT01227668|B2|Baseline|Placebo|Phase 2: Participants received placebo for 16 weeks.
851568|NCT01227629|P3|Participant Flow|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851570|NCT01227629|P1|Participant Flow|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851515|NCT01227668|P1|Participant Flow|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|"Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.~Phase 2: Aripiprazole was continued at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability."
851516|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
851517|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
851518|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
851519|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo (pb)for 16 weeks.
851583|NCT01227629|O5|Outcome|D150bid|Dabigatran 150 mg twice daily
851520|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole (ARP) at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
851521|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
851522|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
851523|NCT01227668|O2|Outcome|Placebo|Phase 2 only: Participants received placebo for 16 weeks.
851524|NCT01227668|O1|Outcome|Aripiprazole, 2-15 mg Once Daily (Titered to Optimum Dose)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
851525|NCT01227668|E3|Reported Event|Placebo (Phase 2 Only)|Phase 2 only: Participants received placebo for 16 weeks.
851526|NCT01227668|E2|Reported Event|Aripiprazole, 2-15 mg (Phase 2)|Phase 2: Participants continued aripiprazole at the dose prescribed at the end of Phase 1, once daily for 16 weeks. The dose (within the range of 2-15 mg/day) could have been adjusted based on efficacy and tolerability.
851527|NCT01227668|E1|Reported Event|Aripiprazole, 2-15 mg (Phase 1)|Phase 1: Participants received an initial dose of aripiprazole 2 mg daily, titered up to 5, 10, or 15 mg once daily to optimize clinical benefit, for a maximum of 26 weeks.
851528|NCT01227655|B4|Baseline|Total|Total of all reporting groups
851529|NCT01227655|B3|Baseline|Placebo|Placebo: comparator
851530|NCT01227655|B2|Baseline|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
851531|NCT01227655|B1|Baseline|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
851532|NCT01227655|P3|Participant Flow|Placebo|Placebo: comparator
851533|NCT01227655|P2|Participant Flow|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
851534|NCT01227655|P1|Participant Flow|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
851535|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
851536|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
851537|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
851538|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
851539|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
851540|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
851541|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
851542|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
851543|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
851544|NCT01227655|O3|Outcome|Placebo|Placebo: comparator
851545|NCT01227655|O2|Outcome|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
851546|NCT01227655|O1|Outcome|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
851547|NCT01227655|E3|Reported Event|Placebo|Placebo: comparator
851548|NCT01227655|E2|Reported Event|BIA 9-1067 50 mg|BIA 9-1067 once daily (QD).
851549|NCT01227655|E1|Reported Event|BIA 9-1067 25 mg|BIA 9-1067 once daily (QD).
851550|NCT01227629|B11|Baseline|Total|Total of all reporting groups
851551|NCT01227629|B10|Baseline|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851552|NCT01227629|B9|Baseline|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851553|NCT01227629|B8|Baseline|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851554|NCT01227629|B7|Baseline|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851555|NCT01227629|B6|Baseline|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851556|NCT01227629|B5|Baseline|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851557|NCT01227629|B4|Baseline|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851558|NCT01227629|B3|Baseline|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851559|NCT01227629|B2|Baseline|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851560|NCT01227629|B1|Baseline|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851561|NCT01227629|P10|Participant Flow|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851562|NCT01227629|P9|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851563|NCT01227629|P8|Participant Flow|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851564|NCT01227629|P7|Participant Flow|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851565|NCT01227629|P6|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851566|NCT01227629|P5|Participant Flow|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851567|NCT01227629|P4|Participant Flow|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851571|NCT01227629|O17|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|Warfarin once daily
851572|NCT01227629|O16|Outcome|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
851573|NCT01227629|O15|Outcome|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
851574|NCT01227629|O14|Outcome|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
851575|NCT01227629|O13|Outcome|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
851576|NCT01227629|O12|Outcome|D300qd|Dabigatran 300 mg once daily
851577|NCT01227629|O11|Outcome|D300bid|Dabigatran 300 mg twice daily
851578|NCT01227629|O10|Outcome|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
851579|NCT01227629|O9|Outcome|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
851584|NCT01227629|O4|Outcome|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
851585|NCT01227629|O3|Outcome|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
851586|NCT01227629|O2|Outcome|D50qd|Dabigatran 50 mg once daily
851587|NCT01227629|O1|Outcome|D50bid|Dabigatran 50 mg twice daily
851588|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851589|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851590|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851591|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851592|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851593|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851594|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851595|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851596|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851597|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851598|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851599|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851600|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851601|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851602|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851603|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851604|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851605|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851606|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851607|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851608|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851609|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851610|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851611|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851612|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851613|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851614|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851615|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851616|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851617|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851618|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851619|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851620|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851621|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851622|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851623|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851624|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851625|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851626|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851627|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851628|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851629|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851630|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851631|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851632|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851633|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851634|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851635|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851636|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851637|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851638|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851639|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851640|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851641|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851642|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851643|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851644|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851645|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851646|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851647|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851648|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851649|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851650|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851651|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851652|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851653|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851654|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851655|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851656|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851657|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851658|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851659|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851660|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851661|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851662|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851663|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851664|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851665|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851666|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851667|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851668|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851669|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851670|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851671|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851672|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851673|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851674|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851675|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851676|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851677|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851678|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851679|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851680|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851681|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851682|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851683|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851684|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851685|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851686|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851687|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851688|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851689|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851690|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851691|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851692|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851693|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851694|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851695|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851696|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851697|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851698|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851699|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851700|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851701|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
853587|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
851702|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851703|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851704|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851705|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851706|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851707|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851708|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851709|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851710|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851711|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851712|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851713|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851714|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851715|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851716|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851717|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851718|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851719|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851720|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851721|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851722|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851723|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851724|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851725|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851726|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851727|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851728|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851729|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851730|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851731|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851732|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851733|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851734|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851735|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851736|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851737|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851738|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851739|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851740|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851741|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851742|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851743|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851744|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851745|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851746|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851747|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851748|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851749|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851750|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851751|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851752|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851753|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851754|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851755|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851756|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851757|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851758|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851759|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851760|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851761|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851762|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851763|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851764|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
853588|NCT01222520|O2|Outcome|Telmisartan|
851765|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851766|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851767|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851768|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851769|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851770|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851771|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851772|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851773|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
856698|NCT01214174|O3|Outcome|Dose 3|IBI-10090 1046ug
851774|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851775|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851776|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851777|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851778|NCT01227629|O10|Outcome|Warfarin, Dosed to Target INR 2.0 to 3.0|qd (once daily) oral
851779|NCT01227629|O9|Outcome|BIBR 1048 300 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851780|NCT01227629|O8|Outcome|BIBR 1048 300 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851781|NCT01227629|O7|Outcome|BIBR 1048 300 mg b.i.d|bid (twice daily) oral
851782|NCT01227629|O6|Outcome|BIBR 1048 150 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851783|NCT01227629|O5|Outcome|BIBR 1048 150 mg b.i.d + ASA 81 mg qd|bid (twice daily) oral + qd (once daily) oral
851784|NCT01227629|O4|Outcome|BIBR 1048 150 mg b.i.d|bid (twice daily) oral
851785|NCT01227629|O3|Outcome|BIBR 1048 50 mg b.i.d + ASA 325 mg qd|bid (twice daily) oral + qd (once daily) oral
851786|NCT01227629|O2|Outcome|BIBR 1048 50 mg b.i.d + ASA 81 mg q.d.|bid (twice daily) oral + qd (once daily) oral
851787|NCT01227629|O1|Outcome|BIBR 1048 50 mg b.i.d|bid (twice daily) oral
851788|NCT01227629|E17|Reported Event|Warfarin|Warfarin once daily
851789|NCT01227629|E16|Reported Event|D300qd + ASA325qd|Dabigatran 300 mg once daily + ASA 325 mg once daily
851790|NCT01227629|E15|Reported Event|D300bid + ASA325qd|Dabigatran 300 mg twice daily + ASA 325 mg once daily
851791|NCT01227629|E14|Reported Event|D300qd + ASA81qd|Dabigatran 300 mg once daily + ASA 81 mg once daily
851792|NCT01227629|E13|Reported Event|D300bid + ASA81qd|Dabigatran 300 mg twice daily + ASA 81 mg once daily
851793|NCT01227629|E12|Reported Event|D300qd|Dabigatran 300 mg once daily
851794|NCT01227629|E11|Reported Event|D300bid|Dabigatran 300 mg twice daily
851795|NCT01227629|E10|Reported Event|D150qd + ASA325qd|Dabigatran 150 mg once daily + ASA 325 mg once daily
851796|NCT01227629|E9|Reported Event|D150bid + ASA325qd|Dabigatran 150 mg twice daily + ASA 325 mg once daily
851797|NCT01227629|E8|Reported Event|D150qd + ASA81qd|Dabigatran 150 mg once daily + ASA 81 mg once daily
851798|NCT01227629|E7|Reported Event|D150bid + ASA81qd|Dabigatran 150 mg twice daily + ASA 81 mg once daily
851799|NCT01227629|E6|Reported Event|D150qd|Dabigatran 150 mg once daily
851800|NCT01227629|E5|Reported Event|D150bid|Dabigatran 150 mg twice daily
851801|NCT01227629|E4|Reported Event|D50bid + ASA325qd|Dabigatran 50 mg twice daily + ASA 325 mg once daily
851802|NCT01227629|E3|Reported Event|D50bid + ASA81qd|Dabigatran 50 mg twice daily + ASA 81 mg once daily
851803|NCT01227629|E2|Reported Event|D50qd|Dabigatran 50 mg once daily
851804|NCT01227629|E1|Reported Event|D50bid|Dabigatran 50 mg twice daily
851805|NCT01227577|B1|Baseline|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851806|NCT01227577|P1|Participant Flow|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851807|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851808|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851809|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851810|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851811|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851812|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851813|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851814|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851815|NCT01227577|O1|Outcome|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851816|NCT01227577|E1|Reported Event|Nilotinib|Participants received 300 mg twice daily (b.i.d.). Dose increases to 400 b.i.d. were permitted, per Investigator's discretion.
851817|NCT01227564|B4|Baseline|Total|Total of all reporting groups
851818|NCT01227564|B3|Baseline|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851819|NCT01227564|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
853589|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
851820|NCT01227564|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851821|NCT01227564|P3|Participant Flow|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851822|NCT01227564|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851823|NCT01227564|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851824|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
856699|NCT01214174|O2|Outcome|Dose 2|IBI-10090 776ug
851825|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851826|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851827|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851828|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851829|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851830|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851831|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851832|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851833|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851834|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851835|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851836|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851837|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851838|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851839|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851840|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851841|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851842|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851843|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851844|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851845|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851846|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851847|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851848|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851849|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851850|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851851|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851852|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851853|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851854|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851855|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851856|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851857|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851858|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851859|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851860|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851861|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851862|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851863|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851864|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851865|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851866|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851867|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851868|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851869|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851870|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851871|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851872|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851873|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851874|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851875|NCT01227564|O3|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851876|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851877|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851878|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851879|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851880|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851881|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851882|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
853590|NCT01222520|E2|Reported Event|Telmisartan|
851883|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851884|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851885|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851886|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851887|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851888|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851889|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851890|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851891|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851892|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851893|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851894|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851895|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851896|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851897|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851898|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851899|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851900|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851901|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851902|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851903|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851904|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851905|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851906|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851907|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851908|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851909|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851910|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851911|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851912|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851913|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851914|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851915|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851916|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851917|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
856700|NCT01214174|O1|Outcome|Dose 1|IBI-10090 513ug
851918|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851919|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851920|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851921|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851922|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851923|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851924|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851925|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851926|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851927|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851928|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851929|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851930|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851931|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851932|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851933|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851934|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851935|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851936|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851937|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851938|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851939|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851940|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851941|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851942|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851943|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851944|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851945|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851946|NCT01227564|O4|Outcome|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851947|NCT01227564|O3|Outcome|Overall ACC + QS21|Participants received either 3 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
856701|NCT01214174|E3|Reported Event|Dose 3|IBI-10090 1046ug
851948|NCT01227564|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851949|NCT01227564|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851950|NCT01227564|E3|Reported Event|Placebo|Participants received PBS. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851951|NCT01227564|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851952|NCT01227564|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Investigational product was administered by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, 12, and 18 months.
851953|NCT01227551|B1|Baseline|CVA21|CVA21 monotherapy
851954|NCT01227551|P1|Participant Flow|CVA21|CVA21 monotherapy
851955|NCT01227551|O1|Outcome|CVA21|CVA21 monotherapy
851956|NCT01227551|O1|Outcome|CVA21|CVA21 monotherapy
851957|NCT01227551|E1|Reported Event|CVA21|CVA21 monotherapy
851958|NCT01227512|B3|Baseline|Total|Total of all reporting groups
851959|NCT01227512|B2|Baseline|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851960|NCT01227512|B1|Baseline|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851961|NCT01227512|P2|Participant Flow|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851962|NCT01227512|P1|Participant Flow|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851963|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851964|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851965|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851966|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851967|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851968|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851969|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may titrated based on serum sodium response.
851970|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851971|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851972|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851973|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851974|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851975|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction be may titrated based on serum sodium response.
851976|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851977|NCT01227512|O2|Outcome|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851978|NCT01227512|O1|Outcome|Tolvaptan 15-60mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851979|NCT01227512|E2|Reported Event|Placebo|Placebo tablet with prescribed fluid restriction. After the initial dose, level of fluid restriction may be titrated based on serum sodium response.
851980|NCT01227512|E1|Reported Event|Tolvaptan 15-60 mg/Day|Oral tablet without fluid restriction. After the initial dose, daily dose was to be titrated to 30 mg/day or 60 mg/day based on serum sodium response.
851981|NCT01227434|B3|Baseline|Total|Total of all reporting groups
851982|NCT01227434|B2|Baseline|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851983|NCT01227434|B1|Baseline|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
856702|NCT01214174|E2|Reported Event|Dose 2|IBI-10090 776ug
851984|NCT01227434|P2|Participant Flow|Non-surgical Group|Patients not in need of surgery treated with PD 0332991 at a dose of 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851985|NCT01227434|P1|Participant Flow|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, surgical resection for progression, and resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851986|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851987|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 at a dose of 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851988|NCT01227434|O2|Outcome|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851989|NCT01227434|O1|Outcome|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851990|NCT01227434|E2|Reported Event|Non-surgical Group|Patients not requiring surgery treated with PD 0332991 125 mg daily for 21 consecutive days followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851991|NCT01227434|E1|Reported Event|Surgical Group|PD 0332991 125 mg daily for 7 days prior to an indicated, intended surgical resection for progression, and then resume drug at the same dose after recovery from surgery on a repeating schedule of 21 consecutive days of drug followed by a 7 day break off therapy (cycle length is 28 days). Treatment repeated every 28 days, and in the absence of disease progression patients may receive treatment for 12 cycles. At that time patients given the option to continue on study past 12 cycles, up to a maximum of 24 cycles.
851992|NCT01227421|B4|Baseline|Total|Total of all reporting groups
851993|NCT01227421|B3|Baseline|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
851994|NCT01227421|B2|Baseline|Placebo|placebo tablet twice daily with food for 5 days
851995|NCT01227421|B1|Baseline|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
851996|NCT01227421|P3|Participant Flow|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
851997|NCT01227421|P2|Participant Flow|Placebo|placebo tablet twice daily with food for 5 days
851998|NCT01227421|P1|Participant Flow|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
851999|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852000|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852001|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852002|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852003|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852004|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852005|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852006|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852007|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852008|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852009|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852010|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852011|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852012|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852013|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852014|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852015|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852016|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852017|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852018|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852019|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852020|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852021|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852022|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852023|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852024|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852025|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852026|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852027|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852028|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852029|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852030|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852031|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852032|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852033|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852034|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852035|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852036|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852037|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852038|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852039|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852040|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852041|NCT01227421|O3|Outcome|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852042|NCT01227421|O2|Outcome|Placebo|placebo tablet twice daily with food for 5 days
852043|NCT01227421|O1|Outcome|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852044|NCT01227421|E3|Reported Event|Nitazoxanide|2X 300 mg controlled release tablet twice daily with food for five days
852045|NCT01227421|E2|Reported Event|Placebo|placebo tablet twice daily with food for 5 days
852046|NCT01227421|E1|Reported Event|Nitazoxanide|300 mg nitazoxanide twice daily with food for 5 days
852047|NCT01227395|B3|Baseline|Total|Total of all reporting groups
852048|NCT01227395|B2|Baseline|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852049|NCT01227395|B1|Baseline|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852050|NCT01227395|P2|Participant Flow|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852051|NCT01227395|P1|Participant Flow|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852052|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852053|NCT01227395|O1|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852054|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
852055|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Treatment according to Japanese Package Insert.
852056|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
852057|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Treatment according to Japanese Package Insert.
852058|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852059|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852060|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
852061|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Treatment according to Japanese Package Insert.
852062|NCT01227395|O2|Outcome|Azithromycin Without Allergies|Participants without allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852063|NCT01227395|O1|Outcome|Azithromycin With Allergies|Participants with allergies who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852064|NCT01227395|O2|Outcome|Azithromycin Without Renal Dysfunction|Participants without renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852065|NCT01227395|O1|Outcome|Azithromycin With Renal Dysfunction|Participants with renal dysfunction who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852066|NCT01227395|O2|Outcome|Azithromycin Without Concomitant Drugs|Participants without concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852067|NCT01227395|O1|Outcome|Azithromycin With Concomitant Drugs|Participants with concomitant drugs who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852068|NCT01227395|O2|Outcome|Female|Female Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852069|NCT01227395|O1|Outcome|Male|Male Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852070|NCT01227395|O2|Outcome|>=65 Years|Participants with >=65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852071|NCT01227395|O1|Outcome|<65 Years|Participants with <65 years who taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852072|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852073|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852628|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852074|NCT01227395|O2|Outcome|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852075|NCT01227395|O1|Outcome|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852076|NCT01227395|E2|Reported Event|Azithromycin for Treatment|Participants taking Azithromycin for Treatment according to Japanese Package Insert.
852077|NCT01227395|E1|Reported Event|Azithromycin for Prophylaxis|Participants taking Azithromycin for Prophylaxis according to Japanese Package Insert.
852078|NCT01227382|B1|Baseline|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852079|NCT01227382|P1|Participant Flow|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852080|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852081|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852082|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852083|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852084|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852085|NCT01227382|O1|Outcome|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion with cholangioscopy-guided mini-forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852086|NCT01227382|O1|Outcome|Diagnostic Accuracy of SpyBite Biopsy Forceps Compared to the|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852087|NCT01227382|E1|Reported Event|Indeterminate Biliary Lesions Requiring Tissue Sampling|Each patient underwent triple sampling of the identified biliary lesion or stricture with cholangioscopy-guided Spybite forceps biopsy, standard cytology brushing, and standard forceps biopsy.
852088|NCT01227278|B3|Baseline|Total|Total of all reporting groups
852089|NCT01227278|B2|Baseline|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852090|NCT01227278|B1|Baseline|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852091|NCT01227278|P2|Participant Flow|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852092|NCT01227278|P1|Participant Flow|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852093|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852094|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852095|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852096|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852097|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852098|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852099|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852100|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852101|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852102|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852103|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852104|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852105|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852106|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852107|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852108|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852109|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852110|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852111|NCT01227278|O2|Outcome|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852112|NCT01227278|O1|Outcome|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852113|NCT01227278|E2|Reported Event|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 milligram (mg) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852114|NCT01227278|E1|Reported Event|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
852115|NCT01227265|B4|Baseline|Total|Total of all reporting groups
852116|NCT01227265|B3|Baseline|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852117|NCT01227265|B2|Baseline|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852118|NCT01227265|B1|Baseline|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852119|NCT01227265|P3|Participant Flow|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852120|NCT01227265|P2|Participant Flow|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852121|NCT01227265|P1|Participant Flow|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852122|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852123|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852124|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852125|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852126|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852127|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852128|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852129|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852130|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852131|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852132|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852133|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852134|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852135|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852136|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852137|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852138|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852139|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852140|NCT01227265|O3|Outcome|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852141|NCT01227265|O2|Outcome|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852142|NCT01227265|O1|Outcome|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852143|NCT01227265|E3|Reported Event|Placebo|Participants received preladenant-matching placebo as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extention trial or return for a follow-up visit two (2) weeks later.
852144|NCT01227265|E2|Reported Event|Preladenant 5 mg|Participants received 5 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852145|NCT01227265|E1|Reported Event|Preladenant 2 mg|Participants received 2 mg as a single oral dose twice daily for 12 weeks. Participants could then enroll in an extension trial or return for a follow-up visit two (2) weeks later.
852146|NCT01227057|B3|Baseline|Total|Total of all reporting groups
852147|NCT01227057|B2|Baseline|Arm 2: Case Management|Case Management: Case management
852148|NCT01227057|B1|Baseline|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
852149|NCT01227057|P2|Participant Flow|Arm 2: Case Management|Case Management: Case management
852150|NCT01227057|P1|Participant Flow|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
852151|NCT01227057|O2|Outcome|Arm 2: Case Management|"Case management~Case Management: Case management"
852152|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
852153|NCT01227057|O2|Outcome|Arm 2: Case Management|Case Management: Case management
852154|NCT01227057|O1|Outcome|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
852155|NCT01227057|E2|Reported Event|Arm 2: Case Management|Case Management: Case management
852156|NCT01227057|E1|Reported Event|Arm 1: Cognitive Rehabilitation|"Cognitive rehabilitation and exposure therapy for hoarding~Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding: The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring."
852157|NCT01227018|B1|Baseline|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
852158|NCT01227018|P1|Participant Flow|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
852159|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
852160|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
852442|NCT01225952|B3|Baseline|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852161|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
852162|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
852163|NCT01227018|O1|Outcome|STA-9090|175 mg/m2 STA-9090 intravenously (IV) over 1 hour once a week for 3 weeks (Day 1, Day 8 and Day 15), followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression or unacceptable toxicity.
852164|NCT01227018|E1|Reported Event|STA-9090|175 mg/m2 STA-9090 IV over 1 hour once a week for 3 weeks, followed by a 1 week dose-free interval. The 4-week treatment cycle continues to disease progression.
852165|NCT01227005|B3|Baseline|Total|Total of all reporting groups
852166|NCT01227005|B2|Baseline|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852425|NCT01226043|O2|Outcome|Vial and Syringe|Vial and Syringe used during the crossover phase either at period 1 or at period 2
852167|NCT01227005|B1|Baseline|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852168|NCT01227005|P2|Participant Flow|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852169|NCT01227005|P1|Participant Flow|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852170|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852171|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852172|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852173|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852174|NCT01227005|O2|Outcome|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852175|NCT01227005|O1|Outcome|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852176|NCT01227005|E2|Reported Event|Component Therapy|"Red blood cells, plasma, platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852177|NCT01227005|E1|Reported Event|Whole Blood|"Whole Blood plus pooled platelets~Transfusion of blood products: The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets)."
852178|NCT01226745|B7|Baseline|Total|Total of all reporting groups
852179|NCT01226745|B6|Baseline|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852180|NCT01226745|B5|Baseline|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852181|NCT01226745|B4|Baseline|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852182|NCT01226745|B3|Baseline|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852183|NCT01226745|B2|Baseline|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852184|NCT01226745|B1|Baseline|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852185|NCT01226745|P6|Participant Flow|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852186|NCT01226745|P5|Participant Flow|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852187|NCT01226745|P4|Participant Flow|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852188|NCT01226745|P3|Participant Flow|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852189|NCT01226745|P2|Participant Flow|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852190|NCT01226745|P1|Participant Flow|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852191|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852192|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852193|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852194|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852195|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852196|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852197|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852198|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852199|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852200|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852201|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852202|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852203|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852204|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852205|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852206|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852207|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852208|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852209|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852210|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852211|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852212|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852213|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852214|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852215|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852216|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852217|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852218|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852219|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852220|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852221|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852222|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852223|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852224|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852225|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852226|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852227|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852228|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852229|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852230|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852231|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852232|NCT01226745|O1|Outcome|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852233|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852234|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852235|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852236|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852237|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852238|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852239|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852240|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852241|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852242|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852243|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852244|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852245|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852246|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852247|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852248|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852249|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852250|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852251|NCT01226745|O6|Outcome|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852252|NCT01226745|O5|Outcome|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852253|NCT01226745|O4|Outcome|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852254|NCT01226745|O3|Outcome|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852255|NCT01226745|O2|Outcome|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852256|NCT01226745|O1|Outcome|ONO-4641 0.15 mg - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852257|NCT01226745|E6|Reported Event|Placebo - ONO4641 0.05 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852258|NCT01226745|E5|Reported Event|Placebo - ONO4641 0.10 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852259|NCT01226745|E4|Reported Event|Placebo - ONO4641 0.15 mg|Subjects who were administered with placebo in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852260|NCT01226745|E3|Reported Event|ONO-4641 0.05 mg - 0.05 mg|Subjects who were administered with ONO-4641 at a dose of 0.05 mg in the core study were administered with ONO-4641 at a dose of 0.05 mg once daily in the extension study for a duration of 225 weeks.
852261|NCT01226745|E2|Reported Event|ONO-4641 0.10 mg - 0.10 mg|Subjects who were administered with ONO-4641 at a dose of 0.10 mg in the core study were administered with ONO-4641 at a dose of 0.10 mg once daily in the extension study for a duration of 225 weeks.
852262|NCT01226745|E1|Reported Event|ONO-4641 0.15 Milligram (mg) - 0.15 mg|Subjects who were administered with ONO-4641 at a dose of 0.15 mg in the core study were administered with ONO-4641 at a dose of 0.15 mg once daily in the extension study for a duration of 225 weeks.
852263|NCT01226732|B7|Baseline|Total|Total of all reporting groups
852264|NCT01226732|B6|Baseline|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852265|NCT01226732|B5|Baseline|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852266|NCT01226732|B4|Baseline|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852267|NCT01226732|B3|Baseline|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852268|NCT01226732|B2|Baseline|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852269|NCT01226732|B1|Baseline|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852270|NCT01226732|P6|Participant Flow|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852271|NCT01226732|P5|Participant Flow|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852272|NCT01226732|P4|Participant Flow|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852605|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852273|NCT01226732|P3|Participant Flow|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852274|NCT01226732|P2|Participant Flow|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852275|NCT01226732|P1|Participant Flow|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852276|NCT01226732|O1|Outcome|All Patients|The Response Rate is determined for all patients
852277|NCT01226732|O6|Outcome|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852426|NCT01226043|O1|Outcome|SoloSTAR® Pen|SoloSTAR® Pen used during the crossover phase either at period 1 or at period 2
852278|NCT01226732|O5|Outcome|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852279|NCT01226732|O4|Outcome|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852280|NCT01226732|O3|Outcome|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852281|NCT01226732|O2|Outcome|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852282|NCT01226732|O1|Outcome|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852283|NCT01226732|O1|Outcome|All Patients|The Maximum Tolerated Dose (MTD) is determined for all patients
852284|NCT01226732|E6|Reported Event|Dose Level 6|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1250mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852285|NCT01226732|E5|Reported Event|Dose Level 5|"Hsp90 Inhibitor AUY922: 70mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852286|NCT01226732|E4|Reported Event|Dose Level 4|"Hsp90 Inhibitor AUY922: 55mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852287|NCT01226732|E3|Reported Event|Dose Level 3|"Hsp90 Inhibitor AUY922: 40mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852288|NCT01226732|E2|Reported Event|Dose Level 2|"Hsp90 Inhibitor AUY922: 28mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852289|NCT01226732|E1|Reported Event|Dose Level 1|"Hsp90 Inhibitor AUY922: 22mg/m2 IV days 1, 8, and 15 of 21-day cycles Capecitabine: 1000mg/m2 PO BID d 1-14 of 21-day cycles~Capecitabine: Taken orally twice daily on Days 1 through 14 of 21 day cycle.~Hsp90 Inhibitor AUY 922: IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle"
852290|NCT01226719|B1|Baseline|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852291|NCT01226719|P1|Participant Flow|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852292|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852340|NCT01226459|P2|Participant Flow|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852293|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852294|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852295|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852314|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852296|NCT01226719|O1|Outcome|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852297|NCT01226719|E1|Reported Event|FOLFOXIRI+Panitumumab Regimen|"All patients will receive the FOLFOXIRI/panitumumab regimen, with drugs administered in the following order:~Panitumumab~Oxaliplatin~Irinotecan~Leucovorin~5-Fluorouracil~Panitumumab: 6 mg/kg, 60-90 minute IV infusion every 2 weeks~Oxaliplatin: 85 mg/m2, 2-hour IV infusion every 2 weeks~Irinotecan: 125 mg/m2, 1-hour IV infusion every 2 weeks~Leucovorin: 200 mg/m2, 2-hour IV infusion every 2 weeks~5-Fluorouracil: 3200 mg/m2 IV, 48-hour continuous infusion every two weeks"
852298|NCT01226511|B3|Baseline|Total|Total of all reporting groups
852299|NCT01226511|B2|Baseline|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
852300|NCT01226511|B1|Baseline|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
852301|NCT01226511|P2|Participant Flow|Placebo/Duloxetine|"Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
852302|NCT01226511|P1|Participant Flow|Duloxetine/Duloxetine|"Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period. Duloxetine was provided in 30-mg capsules.~Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period, and participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period."
852303|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852304|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852305|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852306|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852307|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852413|NCT01226043|O2|Outcome|Vial and Syringe (Period 2)|Patients using Vial and Syringe during period 2 of the crossover phase.
852308|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852309|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852310|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852311|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852312|NCT01226511|O1|Outcome|Duloxetine/Duloxetine (Extension Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852313|NCT01226511|O2|Outcome|Placebo/Duloxetine (Extension Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period and flexible doses of duloxetine 30 to 120 mg orally, QD for 18 weeks during the optional extension treatment period.
852315|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852316|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852317|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852318|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852319|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852320|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852321|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852322|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852323|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852324|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852325|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852326|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852327|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852328|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852329|NCT01226511|O2|Outcome|Placebo (Acute Treatment)|Participants received placebo capsules orally, QD for 10 weeks during the acute treatment period.
852330|NCT01226511|O1|Outcome|Duloxetine (Acute Treatment)|Participants received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks during the acute treatment period.
852331|NCT01226511|E6|Reported Event|Placebo-Taper|AEs during the taper period for participants who were dispensed placebo prior to entering the taper phase. Participants who received the lowest dose of duloxetine or placebo at the end of treatment period participation received placebo over the 2-week recommended tapering period.
852332|NCT01226511|E5|Reported Event|Duloxetine-Taper|AEs during the taper period for participants who were dispensed duloxetine prior to entering the taper phase. Participants who received higher doses of duloxetine at the end of treatment period participation received gradually lower doses of duloxetine over the 2-week recommended tapering period.
852333|NCT01226511|E4|Reported Event|Placebo/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received placebo capsules orally, QD during the acute treatment period (10 weeks) and flexible doses of duloxetine 30 to 120 mg orally, QD during the extension treatment period (up to 18 weeks).
852334|NCT01226511|E3|Reported Event|Duloxetine/Duloxetine-Extension Treatment|AEs during the extension treatment period for participants who received flexible doses of duloxetine 30 to 120 mg orally, QD during both the acute and extension treatment periods (up to 28 weeks).
852335|NCT01226511|E2|Reported Event|Placebo|AEs during the acute treatment period for participants who received placebo capsules orally, QD for 10 weeks.
852336|NCT01226511|E1|Reported Event|Duloxetine|Adverse events (AEs) during the acute treatment period for participants who received flexible doses of duloxetine 30 to 120 milligrams (mg) orally, once daily (QD) for 10 weeks.
852337|NCT01226459|B3|Baseline|Total|Total of all reporting groups
852338|NCT01226459|B2|Baseline|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852339|NCT01226459|B1|Baseline|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852414|NCT01226043|O1|Outcome|SoloSTAR® Pen (Period 1)|Patients using SoloSTAR® pen during period 1 of the crossover phase.
853591|NCT01222520|E1|Reported Event|Telmisartan and Amlodipine FDC|
852341|NCT01226459|P1|Participant Flow|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852342|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852343|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852344|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852345|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852346|NCT01226459|O2|Outcome|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852347|NCT01226459|O1|Outcome|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852424|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
856703|NCT01214174|E1|Reported Event|Dose 1|IBI-10090 513ug
852348|NCT01226459|E2|Reported Event|Minoxidil Foam|"5% Minoxidil Topical Foam~5% Minoxidil Topical Foam: Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852349|NCT01226459|E1|Reported Event|Vehicle Foam|"Vehicle Topical Foam~Vehicle Topical Foam: Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks"
852350|NCT01226420|B1|Baseline|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
852351|NCT01226420|P1|Participant Flow|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
852352|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
852353|NCT01226420|O1|Outcome|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
852354|NCT01226420|E1|Reported Event|Alefacept|Alefacept administration (13 doses): Days 1 and 4 (subcutaneous), Weeks 1-12 (intravenous)
852355|NCT01226121|B4|Baseline|Total|Total of all reporting groups
852356|NCT01226121|B3|Baseline|Day 4 Manipulation|Finger manipulation four days following collagenase injection
852357|NCT01226121|B2|Baseline|Day 2 Manipulation|Finger manipulation two days following collagenase injection
852358|NCT01226121|B1|Baseline|Day 1 Manipulation|Finger manipulation one day following collagenase injection
852359|NCT01226121|P3|Participant Flow|Day 4 Manipulation|Finger manipulation four days following collagenase injection
852360|NCT01226121|P2|Participant Flow|Day 2 Manipulation|Finger manipulation two days following collagenase injection
852361|NCT01226121|P1|Participant Flow|Day 1 Manipulation|Finger manipulation one day following collagenase injection
852362|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
852363|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
852364|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
852365|NCT01226121|O3|Outcome|Day 4 Manipulation|Finger manipulation four days following collagenase injection
852366|NCT01226121|O2|Outcome|Day 2 Manipulation|Finger manipulation two days following collagenase injection
852367|NCT01226121|O1|Outcome|Day 1 Manipulation|Finger manipulation one day following collagenase injection
852368|NCT01226121|E3|Reported Event|Day 4 Manipulation|Finger manipulation four days following collagenase injection
852369|NCT01226121|E2|Reported Event|Day 2 Manipulation|Finger manipulation two days following collagenase injection
852370|NCT01226121|E1|Reported Event|Day 1 Manipulation|Finger manipulation one day following collagenase injection
852371|NCT01226095|B1|Baseline|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852372|NCT01226095|P1|Participant Flow|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852373|NCT01226095|O1|Outcome|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852374|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852375|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
852376|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
852377|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852378|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
852379|NCT01226095|O1|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852380|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852381|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
852382|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
852383|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852384|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
852385|NCT01226095|O3|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852386|NCT01226095|O2|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
852387|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
852388|NCT01226095|O3|Outcome|Brufen Retard (All Visits)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information throughout this post-marketing observational study.
852389|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852390|NCT01226095|O1|Outcome|Brufen Retard (Visit 2, Week 2)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 2 weeks.
852391|NCT01226095|O2|Outcome|Brufen Retard (Visit 3, Week 4)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852392|NCT01226095|O1|Outcome|Brufen Retard Baseline (Visit 1)|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis prior to administration of Brufen Retard (open-label ibuprofen sustained release form) at Baseline per the Prescribing Information.
852393|NCT01226095|E1|Reported Event|Brufen Retard|Male or female participants ≥ 18 years of age in Egypt with osteoarthritis who took Brufen Retard (open-label ibuprofen in a sustained release form) administered per the Prescribing Information for 4 weeks.
852394|NCT01226043|B3|Baseline|Total|Total of all reporting groups
852395|NCT01226043|B2|Baseline|Crossover Phase: Vial & Syringe / Pen|Patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2 for the 4-week crossover phase.
852396|NCT01226043|B1|Baseline|Crossover Phase: Pen / Vial & Syringe|Patients randomized to the sequence: Lantus SoloSTAR pen in Period 1 and Lantus vial and syringe in Period 2 for the 4-week crossover phase.
852397|NCT01226043|P4|Participant Flow|Vial and Syringe|Re-randomization phase and the observational phase: patients randomized to Lantus Vial and Syringe.
852398|NCT01226043|P3|Participant Flow|SoloSTAR® Pen|Re-randomization phase and the observational phase: patients randomized to Lantus SoloSTAR® pen.
852399|NCT01226043|P2|Participant Flow|Vial &Syringe (Period 1) / Pen (Period 2)|Crossover phase: patients randomized to the sequence: Lantus vial and syringe in Period 1 and Lantus SoloSTAR pen in Period 2.
852400|NCT01226043|P1|Participant Flow|Pen (Period 1) / Vial & Syringe (Period 2)|Crossover phase: patients randomized to the sequence: Lantus SoloSTAR® pen in Period 1 and Lantus vial and syringe in Period 2.
852401|NCT01226043|O6|Outcome|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
852402|NCT01226043|O5|Outcome|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
852403|NCT01226043|O4|Outcome|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
852404|NCT01226043|O3|Outcome|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
852405|NCT01226043|O2|Outcome|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852406|NCT01226043|O1|Outcome|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852407|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the observational phase.
852408|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the observational phase.
852409|NCT01226043|O2|Outcome|Vial and Syringe|Patients using Vial and Syringe during the re-randomization phase.
852410|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using SoloSTAR® pen during the re-randomization phase.
852411|NCT01226043|O4|Outcome|Vial and Syringe (Period 1)|Patients using Vial and Syringe during period 1 of the crossover phase.
852412|NCT01226043|O3|Outcome|SoloSTAR® Pen (Period 2)|Patients using SoloSTAR® pen during period 2 of the crossover phase.
854752|NCT01218438|O2|Outcome|Subcutaneous 20%|
852415|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
852416|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
852417|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
852418|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization phase (from Week 4 to Week 10) and the Observational phase (from Week 10 to Week 40).
852419|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
852420|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
852421|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
852422|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
852423|NCT01226043|O2|Outcome|Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
856704|NCT01214161|B3|Baseline|Total|Total of all reporting groups
852427|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852428|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852429|NCT01226043|O2|Outcome|Vial and Syringe|Patients using the Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852430|NCT01226043|O1|Outcome|SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852431|NCT01226043|E6|Reported Event|Observational Phase: Vial and Syringe|Patients using Vial and Syringe during the Observational phase (from Week 10 to Week 40)
852432|NCT01226043|E5|Reported Event|Observational Phase: SoloSTAR® Pen|Patients using SoloSTAR® Pen during the Observational phase (from Week 10 to Week 40)
852433|NCT01226043|E4|Reported Event|Re-randomization Phase: Vial and Syringe|Patients randomized to Vial and Syringe during the Re-randomization period (Week 4 to Week 10)
852434|NCT01226043|E3|Reported Event|Re-randomization Phase: SoloSTAR® Pen|Patients randomized to SoloSTAR® Pen during the Re-randomization period (Week 4 to Week 10)
852435|NCT01226043|E2|Reported Event|Crossover Phase: Vial and Syringe|Patients using Vial and Syringe during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852436|NCT01226043|E1|Reported Event|Crossover Phase: SoloSTAR® Pen|Patients using the SoloSTAR® Pen during the crossover phase either at period 1 or at period 2 depending on the sequence allocated by randomization.
852437|NCT01225991|B1|Baseline|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
852438|NCT01225991|P1|Participant Flow|Milnacipran, Active Drug, Open-label|"All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day, or to their maximum tolerated dose in the course of the first week. The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.~Milnacipran: All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day"
852439|NCT01225991|O1|Outcome|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
852440|NCT01225991|E1|Reported Event|Milnacipran, Active Drug, Open-label|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Subjects will be allowed to escalate up to 100 mg a day or to their maximum tolerated dose in the course of the first week: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day). Final efficacy assessments will be made at the termination visit, and the study medication will be tapered down following 12 weeks of drug treatment.
852441|NCT01225952|B4|Baseline|Total|Total of all reporting groups
852606|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852443|NCT01225952|B2|Baseline|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852444|NCT01225952|B1|Baseline|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852445|NCT01225952|P3|Participant Flow|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852446|NCT01225952|P2|Participant Flow|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852447|NCT01225952|P1|Participant Flow|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852448|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852449|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852450|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852451|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
857613|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
852452|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852453|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852454|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852455|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852456|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852457|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852458|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852459|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852460|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852461|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852462|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852463|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852464|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852465|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852466|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852467|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852468|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852469|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852470|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852471|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852472|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852473|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852474|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852475|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852476|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852477|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852478|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852479|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852480|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852481|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852482|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852483|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852484|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852485|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852486|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852487|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852488|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852489|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852490|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852491|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852492|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852493|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852494|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852495|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852496|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852497|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852498|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852499|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852500|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852501|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852502|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852503|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852504|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852505|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852506|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852507|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852508|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852509|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852510|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852511|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852512|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852513|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852514|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852515|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852516|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852517|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852518|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852519|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852520|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852521|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852522|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852523|NCT01225952|O3|Outcome|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852524|NCT01225952|O2|Outcome|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852525|NCT01225952|O1|Outcome|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852526|NCT01225952|E3|Reported Event|AMO Tecnis Multifocal|A foldable hydrophobic acrylic IOL,(Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL
852527|NCT01225952|E2|Reported Event|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
852528|NCT01225952|E1|Reported Event|Crystalens AO|Bausch & Lomb silicone multi-piece accommodating IOL is a modified plate haptic lens
852529|NCT01225926|B3|Baseline|Total|Total of all reporting groups
854753|NCT01218438|O1|Outcome|Intravenous 10%|
852530|NCT01225926|B2|Baseline|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852531|NCT01225926|B1|Baseline|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852532|NCT01225926|P2|Participant Flow|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852533|NCT01225926|P1|Participant Flow|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852534|NCT01225926|O2|Outcome|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852535|NCT01225926|O1|Outcome|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852625|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40mg qd (once daily) subcutaneous injection
852536|NCT01225926|E2|Reported Event|IQ SN60WF|AcrySof IQ IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852537|NCT01225926|E1|Reported Event|Toric T3 - T9|AcrySof IQ Toric IOL surgically implanted in the capsular bag of the eye following cataract removal. Both eyes were implanted, with the second eye implanted at least 1 week after and within 1 month of the first eye.
852538|NCT01225835|B3|Baseline|Total|Total of all reporting groups
852539|NCT01225835|B2|Baseline|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852540|NCT01225835|B1|Baseline|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852541|NCT01225835|P2|Participant Flow|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852542|NCT01225835|P1|Participant Flow|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852543|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852544|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852545|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852546|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852547|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852548|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852549|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852550|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852607|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852608|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
854754|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
852551|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852552|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852553|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852554|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852555|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852556|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852557|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852558|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852559|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852560|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852561|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852562|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852563|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852564|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852565|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852566|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852567|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852568|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852609|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852610|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852569|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852570|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852571|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852572|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852573|NCT01225835|O2|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852626|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852627|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852574|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852575|NCT01225835|O1|Outcome|All Participants|The analysis of whether progesterone level is a predictor for ongoing pregnancy used all participants.
852576|NCT01225835|O6|Outcome|Follitrophin Alpha: Stratum Age >=39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were >= 39 years old.
852577|NCT01225835|O5|Outcome|Follitrophin Alpha: Stratum Age <39 Yrs|The subset of participants in the follitrophin alpha treatment arm who were < 39 years old.
852578|NCT01225835|O4|Outcome|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852579|NCT01225835|O3|Outcome|Menotrophin: Stratum Age >=39 Yrs|The subset of participants in the menotrophin treatment arm who were >= 39 years old.
852580|NCT01225835|O2|Outcome|Menotrophin: Stratum Age <39 Yrs|The subset of participants in the menotrophin treatment arm who were < 39 years old.
852581|NCT01225835|O1|Outcome|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852582|NCT01225835|E2|Reported Event|Follitrophin Alpha|Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852583|NCT01225835|E1|Reported Event|Menotrophin|Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 13 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms.
852584|NCT01225822|B6|Baseline|Total|Total of all reporting groups
852585|NCT01225822|B5|Baseline|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852586|NCT01225822|B4|Baseline|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852587|NCT01225822|B3|Baseline|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852588|NCT01225822|B2|Baseline|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852589|NCT01225822|B1|Baseline|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852590|NCT01225822|P5|Participant Flow|Enoxaparin 40 mg qd|Enoxaparin 40 qd (once daily) subcutaneous injection
852591|NCT01225822|P4|Participant Flow|BIBR 1048 300 mg qd|Dabigatran 300 mg qd(once daily) oral
852592|NCT01225822|P3|Participant Flow|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid(twice daily) oral
852593|NCT01225822|P2|Participant Flow|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid(twice daily) oral
852594|NCT01225822|P1|Participant Flow|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid(twice daily) oral
852595|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852596|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852597|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852598|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852599|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852600|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852601|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852602|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852603|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852604|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852611|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852612|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852613|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852614|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852615|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852616|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852617|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852618|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852619|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852620|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852621|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852622|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852623|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852624|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852629|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852630|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mgqd (once daily) subcutaneous injection
852631|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852632|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852633|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852634|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852635|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852636|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852637|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852638|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852639|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852640|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852641|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852642|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852643|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852644|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852645|NCT01225822|O5|Outcome|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852646|NCT01225822|O4|Outcome|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852647|NCT01225822|O3|Outcome|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852648|NCT01225822|O2|Outcome|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852649|NCT01225822|O1|Outcome|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852650|NCT01225822|E5|Reported Event|Enoxaparin 40 mg qd|Enoxaparin 40 mg qd (once daily) subcutaneous injection
852651|NCT01225822|E4|Reported Event|BIBR 1048 300 mg qd|Dabigatran 300 mg qd (once daily) oral
852652|NCT01225822|E3|Reported Event|BIBR 1048 225 mg Bid|Dabigatran 225 mg bid (twice daily) oral
852653|NCT01225822|E2|Reported Event|BIBR 1048 150 mg Bid|Dabigatran 150 mg bid (twice daily) oral
852654|NCT01225822|E1|Reported Event|BIBR 1048 50 mg Bid|Dabigatran 50 mg bid (twice daily) oral
852655|NCT01225731|B6|Baseline|Total|Total of all reporting groups
852656|NCT01225731|B5|Baseline|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852657|NCT01225731|B4|Baseline|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852658|NCT01225731|B3|Baseline|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852659|NCT01225731|B2|Baseline|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852660|NCT01225731|B1|Baseline|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852661|NCT01225731|P13|Participant Flow|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852662|NCT01225731|P12|Participant Flow|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852663|NCT01225731|P11|Participant Flow|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852664|NCT01225731|P10|Participant Flow|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852665|NCT01225731|P9|Participant Flow|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
852666|NCT01225731|P8|Participant Flow|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
852667|NCT01225731|P7|Participant Flow|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
852668|NCT01225731|P6|Participant Flow|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
852669|NCT01225731|P5|Participant Flow|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852670|NCT01225731|P4|Participant Flow|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852671|NCT01225731|P3|Participant Flow|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852672|NCT01225731|P2|Participant Flow|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852673|NCT01225731|P1|Participant Flow|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852674|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
852675|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
852676|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
852677|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
852678|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852679|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852680|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852681|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852682|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852683|NCT01225731|O13|Outcome|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
852684|NCT01225731|O12|Outcome|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
857614|NCT01212094|O1|Outcome|Placebo|Group administered placebo
852685|NCT01225731|O11|Outcome|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
852686|NCT01225731|O10|Outcome|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug
852687|NCT01225731|O9|Outcome|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
852688|NCT01225731|O8|Outcome|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
852689|NCT01225731|O7|Outcome|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
852690|NCT01225731|O6|Outcome|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
852691|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852692|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852693|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852694|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852695|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852696|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852697|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852698|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852699|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852700|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852701|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852702|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852703|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852704|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852705|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852706|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852707|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852708|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852709|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852710|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852711|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852712|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852713|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852714|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852715|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852716|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852717|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852718|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852719|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852720|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852721|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852722|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852723|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852724|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852725|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852726|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852727|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852728|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852729|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852730|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852731|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852732|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852733|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852734|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852735|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852736|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852737|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852738|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
857615|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
852739|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852740|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852741|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852742|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852743|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852744|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852745|NCT01225731|O5|Outcome|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852746|NCT01225731|O4|Outcome|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852747|NCT01225731|O3|Outcome|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852748|NCT01225731|O2|Outcome|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852749|NCT01225731|O1|Outcome|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852750|NCT01225731|E14|Reported Event|Placebo Follow-up|Participants who received placebo in Part 1 and did not receive additional therapy.
852751|NCT01225731|E13|Reported Event|Part 3: Tildrakizumab 200 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852752|NCT01225731|E12|Reported Event|Part 3: Tildrakizumab 100 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852753|NCT01225731|E11|Reported Event|Part 3: Tildrakizumab 25 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852754|NCT01225731|E10|Reported Event|Part 3: Tildrakizumab 5 mg Follow-up|Participants are followed for up to 20 weeks after the last dose of study drug.
852755|NCT01225731|E9|Reported Event|Part 2: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, every 12 weeks for up to 36 weeks
852756|NCT01225731|E8|Reported Event|Part 2: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, every 12 weeks for up to 36 weeks
852757|NCT01225731|E7|Reported Event|Part 2: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, every 12 weeks for up to 36 weeks
852758|NCT01225731|E6|Reported Event|Part 2: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, SC, every 12 weeks for up to 36 weeks
852759|NCT01225731|E5|Reported Event|Part 1: Placebo|Participants receive placebo, SC, at Weeks 0 and 4
852760|NCT01225731|E4|Reported Event|Part 1: Tildrakizumab 200 mg|Participants receive tildrakizumab 200 mg, SC, at Weeks 0 and 4
852761|NCT01225731|E3|Reported Event|Part 1: Tildrakizumab 100 mg|Participants receive tildrakizumab 100 mg, SC, at Weeks 0 and 4
852762|NCT01225731|E2|Reported Event|Part 1: Tildrakizumab 25 mg|Participants receive tildrakizumab 25 mg, SC, at Weeks 0 and 4
852763|NCT01225731|E1|Reported Event|Part 1: Tildrakizumab 5 mg|Participants receive tildrakizumab 5 mg, subcutaneously (SC) at Weeks 0 and 4
852764|NCT01225562|B4|Baseline|Total|Total of all reporting groups
852765|NCT01225562|B3|Baseline|Placebo|Matching placebo
852766|NCT01225562|B2|Baseline|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
852767|NCT01225562|B1|Baseline|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
852768|NCT01225562|P3|Participant Flow|Placebo|Matching placebo
852769|NCT01225562|P2|Participant Flow|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
852770|NCT01225562|P1|Participant Flow|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
852771|NCT01225562|O3|Outcome|Placebo|Matching placebo
852772|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
852773|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
852774|NCT01225562|O3|Outcome|Placebo|Matching placebo
852775|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
852776|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
852777|NCT01225562|O3|Outcome|Placebo|Matching placebo
852778|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
852779|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
852780|NCT01225562|O3|Outcome|Placebo|Matching placebo
852781|NCT01225562|O2|Outcome|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily (BD)
852782|NCT01225562|O1|Outcome|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily (BD)
852783|NCT01225562|E3|Reported Event|Ticagrelor 90mg bd|
852784|NCT01225562|E2|Reported Event|Ticagrelor 60mg bd|
852785|NCT01225562|E1|Reported Event|Placebo|
852786|NCT01225549|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study
853525|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
852787|NCT01225549|P10|Participant Flow|PCBA|Placebo followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg
852788|NCT01225549|P9|Participant Flow|PCAB|Placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg followed by AZD5423 300 µg od
852789|NCT01225549|P8|Participant Flow|PBAC|Placebo followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid
852790|NCT01225549|P7|Participant Flow|CBPA|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo followed by AZD5423 75 µg
852791|NCT01225549|P6|Participant Flow|CBAP|Budesonide 200 µg bid followed by AZD5423 300 µg od followed by AZD5423 75 µg followed by placebo
852792|NCT01225549|P5|Participant Flow|CAPB|Budesonide 200 µg bid followed by AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od
852793|NCT01225549|P4|Participant Flow|BPCA|AZD5423 300 µg od followed by placebo followed by budesonide 200 µg bid followed by AZD5423 75 µg
852794|NCT01225549|P3|Participant Flow|BACP|AZD5423 300 µg od followed by AZD5423 75 µg followed by budesonide 200 µg bid followed by placebo
852795|NCT01225549|P2|Participant Flow|APBC|AZD5423 75 µg followed by placebo followed by AZD5423 300 µg od followed by budesonide 200 µg bid
852796|NCT01225549|P1|Participant Flow|ACBP|AZD5423 75 µg followed by budesonide 200 µg bid followed by AZD5423 300 µg od followed by placebo
855253|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
852797|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852798|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852799|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852800|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852801|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852802|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852803|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852804|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852805|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852806|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852807|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852808|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852809|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852810|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852811|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852812|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852813|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852814|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852815|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852816|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852817|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852818|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852819|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852820|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852821|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852822|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852823|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852824|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852825|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852826|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852827|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852828|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852829|NCT01225549|O4|Outcome|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852830|NCT01225549|O3|Outcome|Arm 3 - 2x200ug Budesonide|200µg budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852831|NCT01225549|O2|Outcome|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852832|NCT01225549|O1|Outcome|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852833|NCT01225549|E4|Reported Event|Arm 4 - Placebo|Placebo administered in any of the first, second, third or fourth period of a particular sequence.
852834|NCT01225549|E3|Reported Event|Arm 3 - 2x200ug Budesonide|2x200ug budesonide administered twice daily in any of the first, second, third or fourth period of a particular sequence.
852835|NCT01225549|E2|Reported Event|Arm 2 - 300ug AZD5423|300ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852836|NCT01225549|E1|Reported Event|Arm 1 - 75ug AZD5423|75ug AZD5423 administered once daily in any of the first, second, third or fourth period of a particular sequence.
852837|NCT01225354|B1|Baseline|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
852838|NCT01225354|P1|Participant Flow|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
852839|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
852840|NCT01225354|O1|Outcome|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
852841|NCT01225354|E1|Reported Event|Calcium Hydroxylapatite|Subject will be treated at baseline and, if needed, at 2 weeks.
852842|NCT01225289|B3|Baseline|Total|Total of all reporting groups
852843|NCT01225289|B2|Baseline|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
852844|NCT01225289|B1|Baseline|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
852845|NCT01225289|P2|Participant Flow|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
852846|NCT01225289|P1|Participant Flow|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
852847|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
852848|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
852849|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
852850|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
852851|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
852852|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
852853|NCT01225289|O2|Outcome|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
852854|NCT01225289|O1|Outcome|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
852855|NCT01225289|E2|Reported Event|With Multiple Sclerosis/ Placebo|Patients with Multiple Sclerosis confirmed Relapsing Remitting Type who receive 1 cap of placebo/day
852856|NCT01225289|E1|Reported Event|With Multiple Sclerosis/ Vitamin A|Patients with MS confirmed Relapsing Remitting Type who receive 25000 IU/day vitamin A
852857|NCT01225263|B3|Baseline|Total|Total of all reporting groups
852858|NCT01225263|B2|Baseline|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
852859|NCT01225263|B1|Baseline|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
852860|NCT01225263|P2|Participant Flow|"Placebo Sugar Pill"|Participants in this arm took placebo pills, which looked like the Simvastatin and Vitamin D. Two placebo pills were taken twice daily for 6 months.
852861|NCT01225263|P1|Participant Flow|Simvastatin and Vitamin D|Participants in this arm took Simvastatin 20 mg twice daily for 6 months plus Vitamin D3 1000 IU twice daily for 6 months.
852862|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the Simvastatin pill and Vitamin D pill. Two placebo pills were taken twice daily for 6 months
852863|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
852864|NCT01225263|O2|Outcome|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
852865|NCT01225263|O1|Outcome|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
852866|NCT01225263|E2|Reported Event|Placebo|Participants in this arm received placebo pills, which looked like the simvastatin and Vitamin D pills, taken twice daily for 6 months
852867|NCT01225263|E1|Reported Event|Simvastatin and Vitamin D|Participants in this arm received Simvastatin 20 mg twice daily and Vitamin D3 1000 IU twice daily for 6 months.
852868|NCT01225211|B11|Baseline|Total|Total of all reporting groups
852869|NCT01225211|B10|Baseline|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852870|NCT01225211|B9|Baseline|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852871|NCT01225211|B8|Baseline|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852872|NCT01225211|B7|Baseline|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852873|NCT01225211|B6|Baseline|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852874|NCT01225211|B5|Baseline|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852875|NCT01225211|B4|Baseline|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852876|NCT01225211|B3|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
853205|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
852877|NCT01225211|B2|Baseline|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
852878|NCT01225211|B1|Baseline|Cohort 1: Placebo|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
852879|NCT01225211|P10|Participant Flow|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852880|NCT01225211|P9|Participant Flow|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852881|NCT01225211|P8|Participant Flow|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852882|NCT01225211|P7|Participant Flow|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO&HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852883|NCT01225211|P6|Participant Flow|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852884|NCT01225211|P5|Participant Flow|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852885|NCT01225211|P4|Participant Flow|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852886|NCT01225211|P3|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
852887|NCT01225211|P2|Participant Flow|Cohort 1: LUM 200 mg qd/LUM 200 mg qd+IVA 150 mg q12h|Participants homozygous for the F508del-CFTR mutation received 200 milligram (mg) of lumacaftor (LUM) qd (Day 1 through Day 14), followed by 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor (IVA) q12h (Day 15 through Day 21).
852888|NCT01225211|P1|Participant Flow|Cohort 1: Placebo|Participants homozygous (HO) for the F508del-CF transmembrane conductance regulator gene (CFTR) mutation received lumacaftor matched placebo once daily (qd) (Day 1 through Day 14), followed by lumacaftor matched placebo qd in combination with ivacaftor matched placebo every 12 hours (q12h) (Day 15 through Day 21).
852889|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852890|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852891|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852892|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852893|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852894|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852895|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852896|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852897|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852898|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852899|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852900|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852901|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852902|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852903|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852904|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852905|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852906|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852907|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852908|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852909|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE)|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28), followed by lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852910|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h/LUM 400 mg q12h+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28), followed by 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852911|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HE)|Participants heterozygous (HE) for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852912|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd/LUM 600 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852913|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd/LUM 400 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852914|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd/LUM 200 mg qd+IVA 250 mg q12h (HO)|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28), followed by 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852915|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852916|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852917|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852918|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852919|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852920|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852921|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852922|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852923|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852924|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852925|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852926|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852927|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
852928|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
852929|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
855254|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
852930|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
852931|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
852932|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
852933|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852934|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852935|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
852936|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
852937|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd (HE) – Period 1|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
852938|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd (HO) – Period 1|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
852939|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
852940|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
852941|NCT01225211|O2|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
852942|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
852943|NCT01225211|O2|Outcome|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852944|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852945|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852946|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852947|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HE) – Period 2|Participants heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852948|NCT01225211|O3|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852949|NCT01225211|O2|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852950|NCT01225211|O1|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852951|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
852952|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
852953|NCT01225211|O1|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
853583|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
852954|NCT01225211|O2|Outcome|Cohort 4: Active Study Drug|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852955|NCT01225211|O1|Outcome|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852956|NCT01225211|O10|Outcome|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852957|NCT01225211|O9|Outcome|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852958|NCT01225211|O8|Outcome|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852959|NCT01225211|O7|Outcome|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852960|NCT01225211|O6|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852961|NCT01225211|O5|Outcome|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
852962|NCT01225211|O4|Outcome|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
852963|NCT01225211|O3|Outcome|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
852964|NCT01225211|O2|Outcome|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
852965|NCT01225211|O1|Outcome|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
852966|NCT01225211|O5|Outcome|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
852967|NCT01225211|O4|Outcome|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
852968|NCT01225211|O3|Outcome|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
852969|NCT01225211|O2|Outcome|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
852970|NCT01225211|O1|Outcome|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
852971|NCT01225211|E17|Reported Event|Cohort 4: LUM 400 mg q12h+IVA 250 mg q12h|Participants heterozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 1 through Day 56).
852972|NCT01225211|E16|Reported Event|Cohort 4: Placebo|Participants heterozygous for the F508del-CFTR mutation received lumacaftor in combination with ivacaftor matched placebo q12h (Day 1 through Day 56).
852973|NCT01225211|E15|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo in combination with ivacaftor matched placebo q12h (Day 29 through Day 56).
852974|NCT01225211|E14|Reported Event|Cohort 3: LUM 400 mg q12h+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor q12h in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852975|NCT01225211|E13|Reported Event|Cohort 2: LUM 600 mg qd+IVA 250 mg q12h (HO&HE) – Period 2|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852976|NCT01225211|E12|Reported Event|Cohort 2: LUM 400 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852977|NCT01225211|E11|Reported Event|Cohort 2: LUM 200 mg qd+IVA 250 mg q12h (HO) – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 29 through Day 56).
852978|NCT01225211|E10|Reported Event|Cohort 2 and 3: Placebo (HO and HE) – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 28).
852979|NCT01225211|E9|Reported Event|Cohort 3: LUM 400 mg q12h – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone q12h (Day 1 through Day 28).
852980|NCT01225211|E8|Reported Event|Cohort 2: LUM 600 mg qd – Period 1|Participants homozygous or heterozygous for the F508del-CFTR mutation received 600 mg of lumacaftor alone qd (Day 1 through Day 28).
852981|NCT01225211|E7|Reported Event|Cohort 2: LUM 400 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 400 mg of lumacaftor alone qd (Day 1 through Day 28).
852982|NCT01225211|E6|Reported Event|Cohort 2: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 28).
852983|NCT01225211|E5|Reported Event|Cohort 1: Placebo – Period 2|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd in combination with ivacaftor matched placebo q12h (Day 15 through Day 21).
852984|NCT01225211|E4|Reported Event|Cohort 1: Placebo – Period 1|Participants homozygous for the F508del-CFTR mutation received lumacaftor matched placebo qd (Day 1 through Day 14).
852985|NCT01225211|E3|Reported Event|Cohort 1: LUM 200 mg qd+IVA 250 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 250 mg of ivacaftor q12h (Day 15 through Day 21).
852986|NCT01225211|E2|Reported Event|Cohort 1: LUM 200 mg qd+IVA 150 mg q12h – Period 2|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor qd in combination with 150 mg of ivacaftor q12h (Day 15 through Day 21).
852987|NCT01225211|E1|Reported Event|Cohort 1: LUM 200 mg qd – Period 1|Participants homozygous for the F508del-CFTR mutation received 200 mg of lumacaftor alone qd (Day 1 through Day 14).
852988|NCT01225159|B3|Baseline|Total|Total of all reporting groups
852989|NCT01225159|B2|Baseline|Conventional Glycaemic Control (Control)|Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
852990|NCT01225159|B1|Baseline|Tight Glycaemic Control (TGC)|TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
852991|NCT01225159|P2|Participant Flow|Conventional Glycaemic Control (Control)|"Allocated to control group (n = 100)~• Received allocated intervention (n = 100)"
852992|NCT01225159|P1|Participant Flow|Tight Glycaemic Control (TGC)|"Allocated to intensive group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
852993|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
852994|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
852995|NCT01225159|O2|Outcome|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
852996|NCT01225159|O1|Outcome|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
852997|NCT01225159|E2|Reported Event|Conventional Glycaemic Control (Control)|"Allocated to intensive group (n = 100)~• Received allocated intervention (n = 100)"
852998|NCT01225159|E1|Reported Event|Tight Glycaemic Control (TGC)|"Allocated to control group (n = 100)~Received allocated intervention (n = 99)~Did not receive allocated intervention: change operation (n = 1)"
852999|NCT01225068|B3|Baseline|Total|Total of all reporting groups
853000|NCT01225068|B2|Baseline|Placebo|Placebo treatment group
853001|NCT01225068|B1|Baseline|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
853002|NCT01225068|P2|Participant Flow|Placebo|Placebo treatment group
853003|NCT01225068|P1|Participant Flow|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
853004|NCT01225068|O2|Outcome|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
853005|NCT01225068|O1|Outcome|Placebo|Placebo arm
853006|NCT01225068|E2|Reported Event|Placebo|Placebo treatment group
853007|NCT01225068|E1|Reported Event|Milnacipran|Milnacipran : Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
853008|NCT01225029|B3|Baseline|Total|Total of all reporting groups
853009|NCT01225029|B2|Baseline|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
853010|NCT01225029|B1|Baseline|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
853011|NCT01225029|P2|Participant Flow|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
853012|NCT01225029|P1|Participant Flow|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
853013|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
853014|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
853015|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
853016|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
853017|NCT01225029|O2|Outcome|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
853018|NCT01225029|O1|Outcome|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
853019|NCT01225029|E2|Reported Event|Restricted Fluids|Preterm neonates receive total fluids of 60 mL/kg/day on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved
853020|NCT01225029|E1|Reported Event|Standard Fluids|Term neonates receive total fluids of 60 mL/kg/day on day of life (DOL) 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
853178|NCT01224444|O1|Outcome|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≥5mm and ≤20mm.
853021|NCT01224821|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853022|NCT01224821|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853056|NCT01224639|B2|Baseline|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853023|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853024|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853025|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853026|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853027|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853046|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853179|NCT01224444|E1|Reported Event|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
853584|NCT01222520|O2|Outcome|Telmisartan|
853028|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853029|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853057|NCT01224639|B1|Baseline|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853058|NCT01224639|P8|Participant Flow|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853030|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853031|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853032|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853033|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853034|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853035|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853036|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853059|NCT01224639|P7|Participant Flow|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853060|NCT01224639|P6|Participant Flow|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853037|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853038|NCT01224821|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853039|NCT01224821|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of unlabeled tositumomab (TST) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after DD administration and then daily for the next 7 days were used to determine the radioactive clearance (RC) and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose (TD). The TD was administered 7-14 days after the DD and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST. Participants who had completed at least 6 months of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in Study BEX104526 were followed for up to 10 years.
853040|NCT01224782|B1|Baseline|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853041|NCT01224782|P1|Participant Flow|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853042|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853043|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853044|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853045|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853176|NCT01224444|B1|Baseline|All Adenomatous Polyps|Adenomatous polyps (included serrated adenomas) ≤5mm and ≤20mm.
853180|NCT01224431|B3|Baseline|Total|Total of all reporting groups
853047|NCT01224782|O1|Outcome|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853048|NCT01224782|E1|Reported Event|Chronic Kidney Disease, Secondary Hyperparathyroidism|All eligible participants with chronic kidney disease stage 3 and 4 and secondary hyperparathyroidism treated with Zemplar (paricalcitol) capsules according to the local marketing authorization
853049|NCT01224639|B9|Baseline|Total|Total of all reporting groups
853050|NCT01224639|B8|Baseline|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853051|NCT01224639|B7|Baseline|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853052|NCT01224639|B6|Baseline|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853053|NCT01224639|B5|Baseline|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853054|NCT01224639|B4|Baseline|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853055|NCT01224639|B3|Baseline|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853061|NCT01224639|P5|Participant Flow|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853062|NCT01224639|P4|Participant Flow|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853063|NCT01224639|P3|Participant Flow|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853064|NCT01224639|P2|Participant Flow|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853065|NCT01224639|P1|Participant Flow|Low Dose Subcutaneous: TDV|TDV 0.5 milliliter (mL), injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). Takeda’s Tetravalent Dengue Vaccine Candidate (TDV) (previously DENVax) comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 plaque forming units (PFU), TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853066|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853067|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853068|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853069|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853070|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853071|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853072|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853073|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853074|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853075|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853076|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853177|NCT01224444|P1|Participant Flow|All Adenomatous Polyps|Standard polypectomy snare of adenomatous polyps (included serrated adenomas) from ≥5mm to ≤20mm.
853077|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853078|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853079|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853080|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853081|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853082|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853083|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853084|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853197|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
853198|NCT01224236|E2|Reported Event|Control|multivitamin solution without iron
853085|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853086|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853087|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853088|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853089|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853090|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853091|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853092|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853093|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853094|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853095|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853096|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853097|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853098|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853099|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853100|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853236|NCT01223937|B3|Baseline|Total|Total of all reporting groups
853101|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853102|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853103|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853104|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853105|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853106|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853107|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853108|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853199|NCT01224236|E1|Reported Event|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
853200|NCT01224171|B3|Baseline|Total|Total of all reporting groups
855255|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
853109|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853110|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853111|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853112|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853113|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853114|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853115|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853116|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853117|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853118|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853119|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853120|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853121|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853122|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853123|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853124|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853125|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853126|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853127|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853128|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853129|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853130|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853131|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853132|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853201|NCT01224171|B2|Baseline|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853202|NCT01224171|B1|Baseline|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
855256|NCT01217112|O5|Outcome|Placebo|Contains excipients only
853133|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853134|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853135|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853136|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853137|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853138|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853139|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853140|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853141|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853142|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853143|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853144|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853145|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853146|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853147|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853148|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853149|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853150|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853151|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853152|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853153|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853154|NCT01224639|O8|Outcome|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853155|NCT01224639|O7|Outcome|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853156|NCT01224639|O6|Outcome|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853203|NCT01224171|P2|Participant Flow|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853204|NCT01224171|P1|Participant Flow|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853157|NCT01224639|O5|Outcome|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853158|NCT01224639|O4|Outcome|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853159|NCT01224639|O3|Outcome|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853160|NCT01224639|O2|Outcome|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853161|NCT01224639|O1|Outcome|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853162|NCT01224639|E8|Reported Event|High Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853163|NCT01224639|E7|Reported Event|High Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853164|NCT01224639|E6|Reported Event|High Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853165|NCT01224639|E5|Reported Event|High Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2*10^4 PFU, TDV-2: 5*10^4 PFU, TDV-3: 1*10^5 PFU, and TDV-4: 3*10^5 PFU, total virus per dose: 4.7*10^5 PFU.
853166|NCT01224639|E4|Reported Event|Low Dose Intradermal: Placebo|TDV placebo-matching 0.1 mL injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose).
853167|NCT01224639|E3|Reported Event|Low Dose Intradermal: TDV|TDV 0.1 mL, injection, intradermally, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853168|NCT01224639|E2|Reported Event|Low Dose Subcutaneous: Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
853169|NCT01224639|E1|Reported Event|Low Dose Subcutaneous: TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV is a tetravalent dengue vaccine comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8*10^3 PFU, TDV-2: 5*10^3 PFU, TDV-3: 1*10^4 PFU, and TDV-4: 2*10^5 PFU, total virus per dose: 2.2*10^5 PFU.
853170|NCT01224626|B1|Baseline|Linezolid|Participants who have been treated with Zyvox (linezolid).
853171|NCT01224626|P1|Participant Flow|Linezolid|Participants who have been treated with Zyvox (linezolid).
853172|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
853173|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
853174|NCT01224626|O1|Outcome|Linezolid|Participants who have been treated with Zyvox (linezolid).
853175|NCT01224626|E1|Reported Event|Linezolid|Participants who have been treated with Zyvox (linezolid).
853585|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
853181|NCT01224431|B2|Baseline|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
853182|NCT01224431|B1|Baseline|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
853183|NCT01224431|P2|Participant Flow|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
853184|NCT01224431|P1|Participant Flow|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
853185|NCT01224431|O2|Outcome|Normal Saline Via Needleless Injection|needleless injection of normal saline prior to lumbar puncture
853186|NCT01224431|O1|Outcome|Needleless Injection of Buffered Lidocaine|needleless injection of buffered lidocaine prior to lumbar puncture
853187|NCT01224431|E2|Reported Event|Placebo Comparator: Normal Saline Via Needleless Injection|
853188|NCT01224431|E1|Reported Event|Experimental: Needleless Injection of Buffered Lidocaine|
853189|NCT01224236|B3|Baseline|Total|Total of all reporting groups
853190|NCT01224236|B2|Baseline|Control|multivitamin solution without iron
853191|NCT01224236|B1|Baseline|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
853192|NCT01224236|P2|Participant Flow|Control|multivitamin solution without iron
853193|NCT01224236|P1|Participant Flow|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
853194|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
853195|NCT01224236|O1|Outcome|Iron Supplementation|2 mg/kg/day of elemental iron as a multivitamin with iron solution
853196|NCT01224236|O2|Outcome|Control|multivitamin solution without iron
853206|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853207|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853208|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853209|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853210|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853211|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853212|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853213|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853214|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853215|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853216|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853217|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853218|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853219|NCT01224171|O2|Outcome|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853220|NCT01224171|O1|Outcome|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853221|NCT01224171|E2|Reported Event|Vedolizumab|Participants received 300 mg intravenous vedolizumab at Weeks 0, 2, and 6.
853222|NCT01224171|E1|Reported Event|Placebo|Participants received placebo intravenous infusion at Weeks 0, 2 and 6.
853223|NCT01224015|B4|Baseline|Total|Total of all reporting groups
853224|NCT01224015|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853225|NCT01224015|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853226|NCT01224015|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853227|NCT01224015|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853228|NCT01224015|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853229|NCT01224015|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853230|NCT01224015|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853231|NCT01224015|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853232|NCT01224015|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853233|NCT01224015|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853234|NCT01224015|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853235|NCT01224015|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow’s Feet Line and Frown Line areas per treatment. Patients received up to 2 treatments during the study.
853237|NCT01223937|B2|Baseline|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853238|NCT01223937|B1|Baseline|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853239|NCT01223937|P2|Participant Flow|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853240|NCT01223937|P1|Participant Flow|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853241|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853242|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853243|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853244|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853486|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853245|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853246|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853247|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853248|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853249|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853250|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853251|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853252|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853253|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853254|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853255|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853256|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853257|NCT01223937|O2|Outcome|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853258|NCT01223937|O1|Outcome|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853259|NCT01223937|E2|Reported Event|Desmopressin 25 μg|Participants took 1 orally disintegrating tablet of desmopressin 25 μg every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853260|NCT01223937|E1|Reported Event|Placebo|Participants took 1 orally disintegrating tablet of placebo every night approximately 1 hour before bedtime for the entire duration of the 3-month treatment period.
853261|NCT01223703|B3|Baseline|Total|Total of all reporting groups
853262|NCT01223703|B2|Baseline|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
853263|NCT01223703|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
853264|NCT01223703|P2|Participant Flow|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
853265|NCT01223703|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
853266|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
853267|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
853268|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
853269|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
853270|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
853271|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
853272|NCT01223703|O2|Outcome|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
853273|NCT01223703|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
853274|NCT01223703|E2|Reported Event|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
853275|NCT01223703|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
853276|NCT01223469|B3|Baseline|Total|Total of all reporting groups
855257|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
853277|NCT01223469|B2|Baseline|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
853278|NCT01223469|B1|Baseline|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
853279|NCT01223469|P2|Participant Flow|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT
853280|NCT01223469|P1|Participant Flow|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
853281|NCT01223469|O2|Outcome|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
853282|NCT01223469|O1|Outcome|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
853283|NCT01223469|E2|Reported Event|Right-sided Supraventricular Tachycardia|Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.
853284|NCT01223469|E1|Reported Event|Atrial Fibrillation|Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.
853285|NCT01223365|B1|Baseline|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at th3 successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853286|NCT01223365|P1|Participant Flow|Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at the successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853287|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853288|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853289|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853290|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853291|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853292|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853293|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853294|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853347|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853295|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853296|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853297|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853298|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853299|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853359|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853300|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853301|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853302|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853303|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853304|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853305|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853306|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853307|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853308|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853309|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853310|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853311|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853312|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853313|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853466|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853586|NCT01222520|O2|Outcome|Telmisartan|
853314|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853315|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853316|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853317|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853318|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853319|NCT01223365|O4|Outcome|Total Hydrocodone ER|Participants were titrated (or re-titrated for roll-over participants) at escalating dosages of hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours until deemed successful for managing their pain during the open-label titration period. Once a successful dose was identified, participants entered the 52 week open-label treatment period in which hydrocodone ER was administered at a successful dose (15, 30, 45, 60, or 90 mg) every 12 hours.
853320|NCT01223365|O3|Outcome|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853321|NCT01223365|O2|Outcome|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853322|NCT01223365|O1|Outcome|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853323|NCT01223365|E3|Reported Event|Rollover Subpopulation|The subpopulation of participants who completed study C33237/3079 (NCT01240863) and 'rolled over' to participate in this study.
853324|NCT01223365|E2|Reported Event|New Opioid Experienced Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid experienced (ie, those who were taking 10 mg/day or more of oxycodone or equivalent, but not more than 135 mg/day, including around-the-clock medication and rescue medications, for the 14 days immediately before screening).
853325|NCT01223365|E1|Reported Event|New Opioid Naïve Subpopulation|The subpopulation of participants who enrolled in this study without previous participation in study C33237/3079 (NCT01240863) and were categorized as opioid naïve (ie, those who were taking less than 10 mg/day of oxycodone or equivalent for the 14 days immediately before screening).
853326|NCT01223196|B3|Baseline|Total|Total of all reporting groups
853327|NCT01223196|B2|Baseline|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
853328|NCT01223196|B1|Baseline|Placebo|One arm of the study subjects will be treated with Placebo only.
853329|NCT01223196|P2|Participant Flow|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
853330|NCT01223196|P1|Participant Flow|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
853331|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone, 15mg, 1 capsule/day.
853332|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only, once a day.
853333|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
853334|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
853335|NCT01223196|O2|Outcome|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
853336|NCT01223196|O1|Outcome|Placebo|One arm of the study subjects will be treated with Placebo only.
853337|NCT01223196|E2|Reported Event|Pioglitazone|One arm of the study subjects will be treated with Pioglitazone
853338|NCT01223196|E1|Reported Event|Placebo|One arm of the study subjects will be treated with Placebo only.
853339|NCT01223027|B3|Baseline|Total|Total of all reporting groups
853340|NCT01223027|B2|Baseline|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853341|NCT01223027|B1|Baseline|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853342|NCT01223027|P2|Participant Flow|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853343|NCT01223027|P1|Participant Flow|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853344|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853345|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853346|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853348|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853349|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853350|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853351|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853352|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853353|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853354|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853355|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853356|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853357|NCT01223027|O2|Outcome|Sorafenib + BSC|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853358|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853360|NCT01223027|O1|Outcome|Dovitinib + Best Supportive Care (BSC)|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853361|NCT01223027|E2|Reported Event|Sorafenib|Patients in the sorafenib control arm received 400 mg of sorafenib (2 x 200 mg tablets) taken orally twice daily.
853362|NCT01223027|E1|Reported Event|Dovitinib|Patients randomized to the dovitinib treatment arm received 500 mg of dovitinib taken orally on 5 days on/2 days off dosing schedule.
853363|NCT01223001|B3|Baseline|Total|Total of all reporting groups
853364|NCT01223001|B2|Baseline|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853365|NCT01223001|B1|Baseline|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853366|NCT01223001|P2|Participant Flow|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853367|NCT01223001|P1|Participant Flow|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853368|NCT01223001|O2|Outcome|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853369|NCT01223001|O1|Outcome|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853370|NCT01223001|E2|Reported Event|Sugar Pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853371|NCT01223001|E1|Reported Event|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
853372|NCT01222884|B3|Baseline|Total|Total of all reporting groups
853373|NCT01222884|B2|Baseline|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
853374|NCT01222884|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
853375|NCT01222884|P2|Participant Flow|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
853376|NCT01222884|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
853377|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
853378|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
853379|NCT01222884|O2|Outcome|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
853380|NCT01222884|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
853381|NCT01222884|E2|Reported Event|Iron Sucrose|"Iron sucrose administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Iron sucrose: Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics"
853382|NCT01222884|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside 1000 (Monofer)administered as 500 mg intravenous single bolus injections OR administered as 500 mg fractionated (100mg+200mg+200mg) intravenous bolus injection~Monofer: Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes"
853383|NCT01222832|B3|Baseline|Total|Total of all reporting groups
853384|NCT01222832|B2|Baseline|Saline|Nasopore sponge soaked in saline
853385|NCT01222832|B1|Baseline|Bacitracin|"Nasopore sponge soaked in Bacitracin~Bacitracin: Bacitracin soaked sponge"
853386|NCT01222832|P2|Participant Flow|Saline|Saline soaked sponge and oral antibiotics
853387|NCT01222832|P1|Participant Flow|Bacitracin|"Nasopore sponge soaked in Bacitracin~Bacitracin: Bacitracin soaked sponge"
853388|NCT01222832|O2|Outcome|Saline|Saline soaked sponge and oral antibiotics
853389|NCT01222832|O1|Outcome|Bacitracin|Bacitracin soaked sponge
853390|NCT01222832|E2|Reported Event|Saline|Saline soaked sponge and oral antibiotics
853391|NCT01222832|E1|Reported Event|Bacitracin|Bacitracin soaked sponge
853392|NCT01222715|B3|Baseline|Total|Total of all reporting groups
853393|NCT01222715|B2|Baseline|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
853434|NCT01222533|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
853394|NCT01222715|B1|Baseline|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
853395|NCT01222715|P2|Participant Flow|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
853396|NCT01222715|P1|Participant Flow|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
853397|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
853398|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
853399|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
853400|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
853401|NCT01222715|O2|Outcome|Regimen B|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Temsirolimus was administered at 15 mg/m2/week intravenously.
853402|NCT01222715|O1|Outcome|Regimen A|The cyclophosphamide plus vinorelbine combination was administered at 1.2 g/m2 every 3 weeks and 25 mg/m2/dose (administered weekly on the first 2 out of every 3 weeks), respectively. Bevacizumab was administered at 15 mg/kg every 3 weeks.
853403|NCT01222715|E2|Reported Event|Regimen B|Vinorelbine/cyclophosphamide (VC) + temsirolimus
853404|NCT01222715|E1|Reported Event|Regimen A|Vinorelbine/cyclophosphamide (VC) + bevacizumab
853405|NCT01222689|B1|Baseline|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib by mouth (PO) every day (QD) and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853406|NCT01222689|P1|Participant Flow|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853407|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853408|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853409|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853410|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853467|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853411|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853412|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853413|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853414|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853415|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853416|NCT01222689|O1|Outcome|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853485|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
857616|NCT01212094|O1|Outcome|Placebo|Group administered placebo
853417|NCT01222689|E1|Reported Event|Treatment (Erlotinib Hydrochloride, Selumetinib)|"Patients receive selumetinib PO QD and erlotinib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~erlotinib hydrochloride: Given PO~selumetinib: Given PO~laboratory biomarker analysis: Correlative studies"
853418|NCT01222585|B1|Baseline|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853419|NCT01222585|P1|Participant Flow|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853420|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853421|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853422|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853423|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853424|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853425|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853426|NCT01222585|O1|Outcome|Metronidazole IV|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853427|NCT01222585|E1|Reported Event|Treatment|Intravenous metronidazole loading dose 15 mg/kg followed by 7.5 mg/kg every 12-24 hours
853428|NCT01222572|B1|Baseline|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
853429|NCT01222572|P3|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 3)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 46 Gy; Stereotactic Boost to Primary: 20 Gy; Total Dose to Primary: 66 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
853430|NCT01222572|P2|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 2)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 50 Gy; Stereotactic Boost to Primary: 15 Gy; Total Dose to Primary: 65 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
853468|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853469|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853470|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853431|NCT01222572|P1|Participant Flow|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
853432|NCT01222572|O1|Outcome|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
853433|NCT01222572|E1|Reported Event|Stereotactic Boost to Chemoradiotherapy (Dose Level 1)|"Chemotherapy: Etoposide 50 mg/m2, d1-5, 29-33 and Cisplatin 50 mg/m2, d1, 8, 29, 36; Conventional RT Dose to Primary: 54 Gy; Stereotactic Boost to Primary: 10 Gy; Total Dose to Primary: 64 Gy~Patients were to start radiation to the primary tumor site and to the lymph nodes and chemotherapy in the same week. The treatment was identical to standard chemotherapy and radiation treatment until the 5th week. During the fifth week, patents would undergo another radiation mapping session to prepare for the stereotactic boost. After that, the radiation treatments to the lymph nodes would continue but the radiation treatment to the primary cancer site would stop until the last week (week 7). During week 7, participants would receive 2 doses of stereotactic radiotherapy to the site of the primary tumor instead of the lower doses of radiotherapy that they were treated with up to that point."
853435|NCT01222533|P1|Participant Flow|Study Overall|Total number of patients randomised and treated in the study. This was a randomised 5-period crossover trial. 154 patients were randomised to one of 15 sequences and treated. The trial was blinded within the 4 Respimat treatments, but open for the HandiHaler treatment. Each of the 5 treatment regimens was taken for 4 weeks without washouts between treatment periods.
853436|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853437|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853438|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853439|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853440|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853441|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853442|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853443|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853444|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853445|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853446|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853447|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853448|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853449|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853450|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853451|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853452|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853453|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853454|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853455|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853456|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853457|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853458|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853459|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853460|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853461|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853462|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853463|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853464|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853465|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853471|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853472|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853473|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853474|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853475|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853476|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853477|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853478|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853479|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853480|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853481|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853482|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853483|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853484|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
857617|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
853487|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853488|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853489|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853490|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853491|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853492|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853493|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853494|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853495|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853496|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853497|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853498|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853499|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853500|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853501|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853502|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853503|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853504|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853505|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853506|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853507|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853508|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853509|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853510|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853511|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853512|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853513|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853514|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853515|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853516|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853517|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853518|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853519|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853520|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853521|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853522|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853523|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853524|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853526|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853527|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853528|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853529|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853530|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853531|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853532|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853533|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853534|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853535|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853536|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853537|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853538|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
855258|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
853539|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853540|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853541|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853542|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853543|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853544|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853545|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853546|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853547|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853548|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853549|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853550|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853551|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853552|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853553|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853554|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853555|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853556|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853557|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853558|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853559|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853560|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853561|NCT01222533|O5|Outcome|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853562|NCT01222533|O4|Outcome|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853563|NCT01222533|O3|Outcome|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853564|NCT01222533|O2|Outcome|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853565|NCT01222533|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853566|NCT01222533|E5|Reported Event|Tio HH18|Open-label tiotropium inhalation capsule 18 mcg delivered by the HandiHaler qd in the morning
853567|NCT01222533|E4|Reported Event|Tio R5|Tiotropium inhalation solution 5 mcg delivered by the Respimat inhaler qd in the morning
853568|NCT01222533|E3|Reported Event|Tio R2.5|Tiotropium inhalation solution 2.5 mcg delivered by the Respimat inhaler qd in the morning
853569|NCT01222533|E2|Reported Event|Tio R1.25|Tiotropium inhalation solution 1.25 mcg delivered by the Respimat inhaler qd in the morning
853570|NCT01222533|E1|Reported Event|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler
853571|NCT01222520|B3|Baseline|Total|Total of all reporting groups
853572|NCT01222520|B2|Baseline|Telmisartan|
853573|NCT01222520|B1|Baseline|Telmisartan and Amlodipine FDC|
853574|NCT01222520|P2|Participant Flow|Telmisartan|
853575|NCT01222520|P1|Participant Flow|Telmisartan and Amlodipine FDC|
853576|NCT01222520|O2|Outcome|Telmisartan|
853577|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
853578|NCT01222520|O2|Outcome|Telmisartan|
853579|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
853580|NCT01222520|O2|Outcome|Telmisartan|
853581|NCT01222520|O1|Outcome|Telmisartan and Amlodipine FDC|
853582|NCT01222520|O2|Outcome|Telmisartan|
853592|NCT01222507|B1|Baseline|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
853593|NCT01222507|P1|Participant Flow|Brain Speed Test (BST)|60 subjects who complete 60 Second Brain Game and Brain Speed Test
853594|NCT01222507|O1|Outcome|Brain Processing Speed|Brain Speed Test is measured through Brain Speed Test, and the results are transformed to z-scores based on normal population data.Z-score is calculated by subtracting the raw score (x) from the mean of the population (µ) which is then divided by the standard deviation of the population.
853595|NCT01222507|E1|Reported Event|Brain Speed Test|60 subjects who complete 60 Second Brain Game and Brain Speed Test
853596|NCT01222403|B3|Baseline|Total|Total of all reporting groups
853597|NCT01222403|B2|Baseline|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853598|NCT01222403|B1|Baseline|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853771|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
853599|NCT01222403|P2|Participant Flow|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853600|NCT01222403|P1|Participant Flow|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853601|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853602|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853603|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853604|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853605|NCT01222403|O2|Outcome|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853606|NCT01222403|O1|Outcome|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853607|NCT01222403|E2|Reported Event|Vantaflu_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853608|NCT01222403|E1|Reported Event|Fluad_aTIV|Subjects aged >65 years received one dose of investigational MF59-adjuvanted trivalent influenza vaccine (aTIV).
853609|NCT01222390|B1|Baseline|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
853610|NCT01222390|P1|Participant Flow|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
853611|NCT01222390|O1|Outcome|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
853612|NCT01222390|E1|Reported Event|Contour Profile Tissue Exander|"Patients undergoing breast reconstruction using a Contour Profile Tissue Expander (CPX3).~Contour Profile Tissue Expander: The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement."
853613|NCT01222286|B3|Baseline|Total|Total of all reporting groups
853614|NCT01222286|B2|Baseline|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853615|NCT01222286|B1|Baseline|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853616|NCT01222286|P2|Participant Flow|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853617|NCT01222286|P1|Participant Flow|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853618|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853619|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853620|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853621|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853622|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853623|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853624|NCT01222286|O2|Outcome|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853625|NCT01222286|O1|Outcome|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853626|NCT01222286|E2|Reported Event|IPH2101 2 mg/kg|2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853627|NCT01222286|E1|Reported Event|IPH2101 0.2 mg/kg|0.2 mg/Kg every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
853628|NCT01222234|B4|Baseline|Total|Total of all reporting groups
853629|NCT01222234|B3|Baseline|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853630|NCT01222234|B2|Baseline|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
853631|NCT01222234|B1|Baseline|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853632|NCT01222234|P3|Participant Flow|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853633|NCT01222234|P2|Participant Flow|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
853924|NCT01221350|E1|Reported Event|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853634|NCT01222234|P1|Participant Flow|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853635|NCT01222234|O2|Outcome|Group 3: Non-CKD Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853636|NCT01222234|O1|Outcome|Group 1: CKD Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853637|NCT01222234|O2|Outcome|Group 2: Calcitriol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Calcitriol 0.25 mcg every day"
853638|NCT01222234|O1|Outcome|Group 1: Cholecalciferol - CKD|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol 50,000 IU twice weekly for 8 weeks"
853639|NCT01222234|E3|Reported Event|Group 3: Cholecalciferol|"Patients in this arm have low vitamin D levels and normal kidney function. They will be put into group 3.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853640|NCT01222234|E2|Reported Event|Group 2: Calcitriol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~calcitriol: calcitriol 0.25 mcg every day"
853641|NCT01222234|E1|Reported Event|Group 1: Cholecalciferol|"Patients in this group have low vitamin D levels and Chronic Kidney Disease (CKD). Patients will be randomized to group 1 or group 2.~Cholecalciferol: Cholecalciferol tablet, 50,000 units twice a week"
853642|NCT01222195|B1|Baseline|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
853643|NCT01222195|P1|Participant Flow|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
853644|NCT01222195|O1|Outcome|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
853645|NCT01222195|E1|Reported Event|Lenalidomide + Darbepoetin Alfa|Lenalidomide 10 mg/day orally days 1-21 and Darbepoetin alfa 200 mcg subcutaneously every 2 weeks of 28 day cycle
853646|NCT01222117|B12|Baseline|Total|Total of all reporting groups
853647|NCT01222117|B11|Baseline|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853648|NCT01222117|B10|Baseline|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853649|NCT01222117|B9|Baseline|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853650|NCT01222117|B8|Baseline|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853651|NCT01222117|B7|Baseline|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853652|NCT01222117|B6|Baseline|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
853653|NCT01222117|B5|Baseline|Plasminogen Activator Blinded Group E|"PA administered for 5 hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
853654|NCT01222117|B4|Baseline|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853655|NCT01222117|B3|Baseline|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853656|NCT01222117|B2|Baseline|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853657|NCT01222117|B1|Baseline|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853658|NCT01222117|P11|Participant Flow|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853659|NCT01222117|P10|Participant Flow|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853660|NCT01222117|P9|Participant Flow|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853661|NCT01222117|P8|Participant Flow|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853662|NCT01222117|P7|Participant Flow|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853663|NCT01222117|P6|Participant Flow|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
853664|NCT01222117|P5|Participant Flow|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
853665|NCT01222117|P4|Participant Flow|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853666|NCT01222117|P3|Participant Flow|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853667|NCT01222117|P2|Participant Flow|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853668|NCT01222117|P1|Participant Flow|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853669|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853670|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853671|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853672|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853673|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853674|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
853675|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
853676|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853677|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853678|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853679|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853680|NCT01222117|O11|Outcome|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853681|NCT01222117|O10|Outcome|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853682|NCT01222117|O9|Outcome|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853683|NCT01222117|O8|Outcome|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853684|NCT01222117|O7|Outcome|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853685|NCT01222117|O6|Outcome|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
853863|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
854755|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
853686|NCT01222117|O5|Outcome|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
853687|NCT01222117|O4|Outcome|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853688|NCT01222117|O3|Outcome|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853689|NCT01222117|O2|Outcome|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853690|NCT01222117|O1|Outcome|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853691|NCT01222117|E11|Reported Event|Plasmin Open-label Treatment Group M|"Open-label 250 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853925|NCT01221311|B3|Baseline|Total|Total of all reporting groups
853692|NCT01222117|E10|Reported Event|Plasmin Open-label Treatment Group J|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 35 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853693|NCT01222117|E9|Reported Event|Plasmin Open-label Treatment Group I|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 30 mL/hour infusion rate with balloon occlusion catheter~Plasmin: Plasmin prepared in 0.9% saline for injection"
853694|NCT01222117|E8|Reported Event|Plasmin Open-label Treatment Group H|"Open-label 150 mg Plasmin administered without pulsing; 2-hour infusion using 75 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853695|NCT01222117|E7|Reported Event|Plasmin Open-label Treatment Group G|"Open-label 150 mg Plasmin administered without pulsing; 5-hour infusion using 60 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853696|NCT01222117|E6|Reported Event|PA Placebo Blinded Treatment Arm F|"PA placebo (normal saline for injection) administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice for PA administration~Placebo: Normal saline for injection at the same volume as the plasminogen activator."
853697|NCT01222117|E5|Reported Event|Plasminogen Activator Blinded Group E|"PA administered for five hours at a dose and volume according to the Investigator's clinical judgement/standard practice~Plasminogen Activator: Plasminogen activator used according to the Investigator's clinical judgment."
853698|NCT01222117|E4|Reported Event|Plasmin Open-label Treatment Group D|"Open-label 150 mg Plasmin administered with proximal pulse; 2-hour infusion using 35 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853699|NCT01222117|E3|Reported Event|Plasmin Open-label Treatment Group C|"Open-label 150 mg Plasmin administered with proximal pulse; 5 hour infusion using 30 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853700|NCT01222117|E2|Reported Event|Plasmin Open-label Treatment Group B|"Open-label 150 mg Plasmin administered with initial proximal pulse; 5-hour infusion using 15 mL/hour infusion rate~Plasmin: Plasmin prepared in 0.9% saline for injection"
853701|NCT01222117|E1|Reported Event|Plasmin Open-label Treatment Group A|"Open-label 150 mg Plasmin administered without initial proximal pulse; 5-hour infusion using 10 mL/hour infusion rate.~Plasmin: Plasmin prepared in 0.9% saline for injection"
853702|NCT01222104|B1|Baseline|All Participants|
853703|NCT01222104|P1|Participant Flow|All Participants|
853704|NCT01222104|O1|Outcome|Participants With Deployment|Participants with successful or attempted Angio-Seal deployments
853705|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
853706|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
853707|NCT01222104|O1|Outcome|All Participants|
853708|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
853709|NCT01222104|O1|Outcome|Participants With Deployments|Participants with successful or attempted Angio-Seal deployments
853710|NCT01222104|O1|Outcome|All Participants With Deployments and Readable Angiograms|
853711|NCT01222104|O1|Outcome|All Participants|All enrolled participants
853712|NCT01222104|O1|Outcome|All Participants|
853713|NCT01222104|O1|Outcome|Angio-Seal|Secondary outcome reported in subjects with successful Angio-Seal deployment which achieved hemostasis by device.
853714|NCT01222104|O1|Outcome|Angio -Seal|Angio-Seal attempted and/or deployed group
853715|NCT01222104|E1|Reported Event|All Participants|
853716|NCT01222078|B1|Baseline|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853717|NCT01222078|P1|Participant Flow|Otelixizumab|Participant received a single dose of otelixizumab intravenous (IV) infusions each given over a 30 minute period on 8 consecutive days in order: 0.1 milligrams (mg), 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before start of infusion (SOI), 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853797|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853718|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853719|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853720|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853772|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
853773|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
853721|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853722|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853723|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853724|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853725|NCT01222078|O1|Outcome|Overall Study Arm|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853726|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853727|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853728|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853729|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853796|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853730|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853731|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853732|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853733|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853774|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
853775|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
853734|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853735|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853736|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853737|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853738|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853739|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853740|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853741|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853742|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853743|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853744|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853745|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853746|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853776|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
853777|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
855259|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
853747|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853748|NCT01222078|O1|Outcome|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853749|NCT01222078|E1|Reported Event|Otelixizumab|Participant received a single dose of otelixizumab IV infusions each given over a 30 minute period on 8 consecutive days in order: 0.1mg, 0.2 mg, 0.3 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg, 0.5 mg thus total dose 3.1 mg. Participant received prophylactic oral ibuprofen 400-800 mg 2 hours before SOI, 2 hours after SOI, 6 hours after SOI and at bedtime. Participant received 5-10 mg oral levocetirizine 1 hour prior to each infusion. Participant was about to receive same study drug dosing after 6 months, though not received.
853750|NCT01221948|B1|Baseline|Deep Brain Stimulation|"Vercise (TM) Rechargeable Deep Brain Stimulation System~Deep Brain Stimulation: Rechargeable Deep Brain Stimulation System"
853751|NCT01221948|P1|Participant Flow|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853752|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853753|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853754|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853755|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853756|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853757|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853758|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853759|NCT01221948|O1|Outcome|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853760|NCT01221948|E1|Reported Event|Deep Brain Stimulation|All enrolled subjects who met study eligiblity recieved Vercise DBS system as part of the study.
853761|NCT01221753|B1|Baseline|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
853762|NCT01221753|P1|Participant Flow|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
853861|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853763|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
853764|NCT01221753|O1|Outcome|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
853765|NCT01221753|E1|Reported Event|TPF Induction Chemotherapy Followed by Chemoradiotherapy|Patients received 3 cycles (21 days each) of TPF induction chemotherapy: docetaxel 75 mg/m2 IV day 1; cisplatin 100 mg/m2 IV day 1 (carboplatin substitute permitted); 5-FU 1000 mg/m2/day IV pump continuous days 1-4. Concurrent chemoradiotherapy followed 4-6 weeks after day 1 of cycle 3 TPF induction: cetuximab 400 mg/m2 IV loading dose 1 week prior and 250 mg/m2 IV weekly (panitumumab substitute permitted); carboplatin AUC 1.5 (Calvert formula) IV weekly; Intensity modulated radiation therapy (IMRT)-response based dosing for 6-7 weeks.
853766|NCT01221727|B3|Baseline|Total|Total of all reporting groups
853767|NCT01221727|B2|Baseline|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16. Out of 9 subjects enrolled and randomized, 8 subjects received investigation product.
853768|NCT01221727|B1|Baseline|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2. Out of 21 subjects enrolled and randomized, 19 subjects received investigation product.
853769|NCT01221727|P2|Participant Flow|Midazolam Only|2 mg oral dose of Midazolam on Day 1 and Day 16.
853770|NCT01221727|P1|Participant Flow|Midazolam With Denosumab|2 mg oral dose of Midazolam on Day 1 and Day 16, 60 mg subcutaneous dose of Denosumab on Day 2
857618|NCT01212094|O1|Outcome|Placebo|Group administered placebo
853778|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16, and 60 mg subcutaneous dose of Denosumab on day 2
853779|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16 , and 60 mg subcutaneous dose of Denosumab on day 2
853780|NCT01221727|O1|Outcome|Midazolam Only|Subjects received 2 mg oral dose of Midazolam on day 1 and day 16
853781|NCT01221727|O1|Outcome|Midazolam With Denosumab|Subjects received 2 mg oral dose of Midazolam on day 1 (serving as a reference point) and day 16 (serving as a test point), and 60 mg subcutaneous dose of Denosumab on day 2
853782|NCT01221727|E6|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 16|
853783|NCT01221727|E5|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 2-15|
853784|NCT01221727|E4|Reported Event|Midazolam Only Group With Midazolam 2mg on Day 1|
853785|NCT01221727|E3|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 16|
853786|NCT01221727|E2|Reported Event|Midazolam With Denosumab Group With Denosumab 60mg on Day 2-15|
853787|NCT01221727|E1|Reported Event|Midazolam With Denosumab Group With Midazolam 2mg on Day 1|
853788|NCT01221623|B3|Baseline|Total|Total of all reporting groups
853789|NCT01221623|B2|Baseline|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853790|NCT01221623|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853791|NCT01221623|P2|Participant Flow|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853792|NCT01221623|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853793|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853794|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853795|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853912|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853798|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853799|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853800|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853801|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
854045|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
853802|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853803|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853804|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853805|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853806|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853807|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853808|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853809|NCT01221623|O2|Outcome|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853810|NCT01221623|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853811|NCT01221623|E2|Reported Event|Placebo|"Placebo~Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853812|NCT01221623|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853813|NCT01221597|B3|Baseline|Total|Total of all reporting groups
853814|NCT01221597|B2|Baseline|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853994|NCT01221090|O4|Outcome|Control|Usual Care
853815|NCT01221597|B1|Baseline|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853816|NCT01221597|P2|Participant Flow|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853817|NCT01221597|P1|Participant Flow|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853818|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853962|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
853819|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853820|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853821|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853822|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853823|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853824|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853825|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853826|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853827|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853828|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853829|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853830|NCT01221597|O2|Outcome|Placebo|placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853862|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853831|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853832|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853833|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853834|NCT01221597|O2|Outcome|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853873|NCT01221363|B1|Baseline|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
857619|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
853835|NCT01221597|O1|Outcome|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853836|NCT01221597|E2|Reported Event|Placebo|Placebo: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
853837|NCT01221597|E1|Reported Event|AA4500|"collagenase clostridium histolyticum~AA4500: 2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles."
853838|NCT01221441|B3|Baseline|Total|Total of all reporting groups
853839|NCT01221441|B2|Baseline|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853840|NCT01221441|B1|Baseline|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853841|NCT01221441|P2|Participant Flow|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853842|NCT01221441|P1|Participant Flow|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853843|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853844|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853845|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853846|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853847|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853848|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853849|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853850|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853851|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853852|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853853|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853854|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853855|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853856|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853857|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853858|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853859|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853860|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853864|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853865|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853866|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853867|NCT01221441|O2|Outcome|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853868|NCT01221441|O1|Outcome|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853869|NCT01221441|E2|Reported Event|Placebo Control|"Normal Saline injection~Normal Saline: Single intraarticular injection of normal saline as a placebo control"
853870|NCT01221441|E1|Reported Event|TissueGene-C|"TissueGene-C at 3 x 10e7 cells per injection (intraarticular)~TissueGene-C: Single intraarticular injection at 3 x 10e7 cells"
853871|NCT01221363|B3|Baseline|Total|Total of all reporting groups
853872|NCT01221363|B2|Baseline|Control Group|No intervention control group
853874|NCT01221363|P2|Participant Flow|Control Group|No intervention control group
854041|NCT01220466|P2|Participant Flow|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
853875|NCT01221363|P1|Participant Flow|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
853876|NCT01221363|O2|Outcome|Control Group|No intervention control group
853877|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
853878|NCT01221363|O2|Outcome|Control Group|No intervention control group
853879|NCT01221363|O1|Outcome|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
853880|NCT01221363|E2|Reported Event|Control Group|No intervention control group
853881|NCT01221363|E1|Reported Event|Lifestyle Counselling|"Theory based individually tailored lifestyle counselling aimed at reduction of sitting time during leisure time and at work. Four individual sessions over a six months period.~Life style intervention: Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention."
853882|NCT01221350|B3|Baseline|Total|Total of all reporting groups
853883|NCT01221350|B2|Baseline|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
853884|NCT01221350|B1|Baseline|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
853885|NCT01221350|P2|Participant Flow|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853886|NCT01221350|P1|Participant Flow|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853887|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853888|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853889|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853890|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853891|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853892|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853893|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853894|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853895|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
853896|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
853897|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853898|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853899|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853900|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853901|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853902|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853903|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853904|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853905|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853906|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853907|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853908|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853909|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853910|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853911|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853913|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
853914|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
853915|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853916|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853917|NCT01221350|O2|Outcome|Placebo|Placebo (two 300 mg capsules filled with vehicle) orally once daily in the morning during 60 days
853918|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid (ALA) 600 mg oral dose (two 300 mg capsules) once daily in the morning during 60 days
853919|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853920|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853921|NCT01221350|O2|Outcome|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853922|NCT01221350|O1|Outcome|Lipoic Acid|Lipoic acid 600 mg dose (two 300 mg capsules, p.o) once daily in the morning
853923|NCT01221350|E2|Reported Event|Placebo|Placebo 600 mg vehicle (two 300 mg capsules, p.o) once daily in the morning
853926|NCT01221311|B2|Baseline|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
853927|NCT01221311|B1|Baseline|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
853928|NCT01221311|P2|Participant Flow|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).~Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
853929|NCT01221311|P1|Participant Flow|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
853930|NCT01221311|O2|Outcome|Plastic Stent|"Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria (details below).~Plastic Stent: Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal"
853931|NCT01221311|O1|Outcome|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
853932|NCT01221311|E2|Reported Event|Plastic Stent|Patients randomized to the plastic stent (PS) group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and multiple (as many as technically feasible) PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing endoscopic retrograde cholangiopancreatography (ERCP), until the stricture has been obliterated using clinical and fluoroscopic criteria.
853933|NCT01221311|E1|Reported Event|Fully Covered Metallic Stent|"Among patients randomized to the covered, self-expandable metallic stent (cSEMS) group, the endoscopist will deploy a cSEMS of sufficient length to traverse the papilla. Dilation will not be performed unless the cSEMS deployment catheter cannot be advanced over a guidewire beyond the stricture. A biliary sphincterotomy may be performed at the discretion of the treating endoscopist.~Fully covered Metallic Stent: Covered Wallflex Biliary (TM)"
853934|NCT01221298|B1|Baseline|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853935|NCT01221298|P1|Participant Flow|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853936|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853937|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853938|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853939|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853940|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853941|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853942|NCT01221298|O1|Outcome|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
853943|NCT01221298|E1|Reported Event|ABT-450/r and ABT-072, Plus Ribavirin (RBV)|ABT-450/r (150/100 mg) once daily (QD) and ABT-072 (400 mg) QD plus weight-based RBV divided twice daily (BID) for 12 weeks.
857620|NCT01212094|O1|Outcome|Placebo|Group administered placebo
853944|NCT01221285|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
853945|NCT01221285|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853946|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853947|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853948|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853949|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853950|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853951|NCT01221285|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853952|NCT01221285|E1|Reported Event|Experimental: German Cockroach Allergenic Extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 ml of extract at a concentration of 1:20 wt/vol.
853953|NCT01221272|B1|Baseline|All Participants|"Baseline characteristics were analyzed as a single group (Safety Analysis Set). All participants were assigned to complete the same treatment periods in the same manner.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853954|NCT01221272|P2|Participant Flow|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853955|NCT01221272|P1|Participant Flow|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853956|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853957|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853958|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853959|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853960|NCT01221272|O2|Outcome|Placebo/Ranolazine|"Period 1: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853961|NCT01221272|O1|Outcome|Ranolazine/Placebo|"Period 1: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Period 2: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
854071|NCT01220297|P1|Participant Flow|Graft-vs-Host Disease (GvHD) Prophlyaxis|Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative
853963|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
853964|NCT01221272|O2|Outcome|Placebo|Placebo treatment period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
853965|NCT01221272|O1|Outcome|Ranolazine|Ranolazine treatment period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.
853966|NCT01221272|E3|Reported Event|Onset at Any Time Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events with onset at any time following ranolazine treatment.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853967|NCT01221272|E2|Reported Event|Onset Following Placebo|"This reporting group includes participants dosed with placebo and their events for which the last dosed treatment was placebo, ie, events with onset during the placebo treatment period or during post-placebo treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853968|NCT01221272|E1|Reported Event|Onset Following Ranolazine|"This reporting group includes participants dosed with ranolazine and their events for which the last dosed treatment was ranolazine, ie, events with onset during the ranolazine treatment period or during post-ranolazine treatment period follow-up.~Ranolazine Treatment Period: Participants received ranolazine 1 × 500 mg tablet administered once in the evening on Day 1, 1 × 500 mg tablet twice daily on Days 2-3, and 2 × 500 tablets twice daily from Day 4 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study.~Placebo Treatment Period: Participants received placebo to match ranolazine from Day 1 to the end of the period (Day 15 ± 2 days), followed by an exercise SPECT MPI study."
853969|NCT01221090|B5|Baseline|Total|Total of all reporting groups
853970|NCT01221090|B4|Baseline|Control|Usual Care
853971|NCT01221090|B3|Baseline|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
853972|NCT01221090|B2|Baseline|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
853973|NCT01221090|B1|Baseline|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
853974|NCT01221090|P4|Participant Flow|Control|Usual Care
853975|NCT01221090|P3|Participant Flow|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
853976|NCT01221090|P2|Participant Flow|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
853977|NCT01221090|P1|Participant Flow|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
853978|NCT01221090|O4|Outcome|Control|Usual Care
853979|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
853980|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
853981|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
853982|NCT01221090|O4|Outcome|Control|Usual Care
853983|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
853984|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
853985|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
853986|NCT01221090|O4|Outcome|Control|Usual Care
853987|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
853988|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
853989|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
853990|NCT01221090|O4|Outcome|Control|Usual Care
853991|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
853992|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
853993|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
853995|NCT01221090|O3|Outcome|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
853996|NCT01221090|O2|Outcome|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
853997|NCT01221090|O1|Outcome|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
853998|NCT01221090|E4|Reported Event|Control|Usual Care
853999|NCT01221090|E3|Reported Event|PDA/CDSMP|"Combined intervention~PDA/CDSMP : Combined technology and education"
854000|NCT01221090|E2|Reported Event|Personal Digital Assistant (PDA)|"Personal digital assistance (technological)~PDA : Technological assistance"
854001|NCT01221090|E1|Reported Event|CDSMP|"6-week educational classes~CDSMP : 6-week classes"
854002|NCT01220869|B1|Baseline|Degarelix|Degarelix 240/80 mg dosing regimen (240 mg is the initiation dose, the 80 mg is the maintenance dose)
854003|NCT01220869|P1|Participant Flow|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
854042|NCT01220466|P1|Participant Flow|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
854004|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
854005|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
854006|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
854007|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
854008|NCT01220869|O1|Outcome|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
854009|NCT01220869|E1|Reported Event|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
854010|NCT01220739|B3|Baseline|Total|Total of all reporting groups
854011|NCT01220739|B2|Baseline|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854012|NCT01220739|B1|Baseline|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854013|NCT01220739|P2|Participant Flow|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854014|NCT01220739|P1|Participant Flow|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854015|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854090|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854438|NCT01219738|O5|Outcome|Placebo|A single inhaled dose of placebo from a DPI
854016|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854017|NCT01220739|O2|Outcome|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854043|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
854044|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
854018|NCT01220739|O1|Outcome|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854019|NCT01220739|E2|Reported Event|Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854020|NCT01220739|E1|Reported Event|Sham Transcranial Laser Therapy|"Subjects in this treatment arm will receive IV tPA within 3 hours of stroke symptom onset followed by sham transcranial laser therapy no sooner than 12 hours after tPA and no greater than 24 hours from stroke onset.~Transcranial Laser Therapy: Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site."
854021|NCT01220609|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
854022|NCT01220609|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
854023|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
854024|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
854025|NCT01220609|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
854026|NCT01220609|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
854027|NCT01220557|B3|Baseline|Total|Total of all reporting groups
854028|NCT01220557|B2|Baseline|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
854029|NCT01220557|B1|Baseline|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
854030|NCT01220557|P2|Participant Flow|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
854031|NCT01220557|P1|Participant Flow|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
854032|NCT01220557|O2|Outcome|Control Group|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
854033|NCT01220557|O1|Outcome|PRIMAS Group|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
854410|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854034|NCT01220557|E2|Reported Event|Control Group|"The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.~DTTP: The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material."
854035|NCT01220557|E1|Reported Event|PRIMAS Group|"PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material~PRIMAS: PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material"
854036|NCT01220466|B4|Baseline|Total|Total of all reporting groups
854037|NCT01220466|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
854038|NCT01220466|B2|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
854039|NCT01220466|B1|Baseline|Hyperopia With or Without Astigmatism|"Hyperopia with and without astigmatism with MRSE up to~+9.00 D, with cylinder between 0.00 and +6.00 D."
854040|NCT01220466|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D ) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
855260|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
854046|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
854047|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
854048|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
854049|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
854050|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
854051|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
854052|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
854053|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
854054|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
854055|NCT01220466|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
854056|NCT01220466|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
854057|NCT01220466|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
854058|NCT01220466|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
854059|NCT01220466|E2|Reported Event|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0 D, with cylinder between 0.00 and -6.00 D.
854060|NCT01220466|E1|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D
854061|NCT01220401|B1|Baseline|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
854062|NCT01220401|P1|Participant Flow|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
854063|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
854064|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
854091|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854065|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
854066|NCT01220401|O1|Outcome|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Treatment consists of psychoeducation, relaxation techniques, mindfulness, exposure to nightmare content, and rescription of nightmare to make it less distressing.~Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
854067|NCT01220401|E1|Reported Event|ERRT-M|"Exposure, Relaxation, and Rescripting Therapy for military populations. 4 sessions.~exposure, relaxation, and rescription therapy: veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)"
854068|NCT01220297|B3|Baseline|Total|Total of all reporting groups
854069|NCT01220297|B2|Baseline|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
854070|NCT01220297|B1|Baseline|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
855261|NCT01217112|O5|Outcome|Placebo|Contains excipients only
854072|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
854073|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
854074|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
854075|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
854076|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
854077|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
854078|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
854079|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
854080|NCT01220297|O2|Outcome|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
854081|NCT01220297|O1|Outcome|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
854082|NCT01220297|E2|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After FTBI + Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after therapeutic regimen of cyclophosphamide (Cyclo) chemotherapy and fractionated total body irradiation (FTBI)
854083|NCT01220297|E1|Reported Event|GvHD Prophylaxis of Sirolimus & MMF After BCNU+VP16+Cyclo|Graft-vs-host disease (GvHD) prophylaxis of sirolimus & mycophenolate mofetil (MMF) after chemotherapeutic regimen of carmustine (BCNU) + etoposide (VP-16) + cyclophosphamide (Cyclo)
854084|NCT01220180|B4|Baseline|Total|Total of all reporting groups
854085|NCT01220180|B3|Baseline|Pregabalin: Fibromyalgia|Pregabalin capsules administered orally starting with a dose of 300 to 450 mg/day in adult participants with fibromyalgia.
854086|NCT01220180|B2|Baseline|Pregabalin: Neuropathic Pain|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with Neuropathic pain (NeP).
854087|NCT01220180|B1|Baseline|Pregabalin: Epilepsy|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy.
854088|NCT01220180|P1|Participant Flow|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 milligram per day (mg/day) which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854089|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854411|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854092|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854093|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854094|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854095|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854096|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854143|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
855262|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
854097|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854098|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854099|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854100|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854101|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854102|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854103|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854104|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854105|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854106|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854107|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854108|NCT01220180|O1|Outcome|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854109|NCT01220180|E1|Reported Event|Pregabalin|Pregabalin capsules administered orally starting with a dose of 150 mg/day which could be increased up to a maximum dosage of 600 mg/day in adult participants with epilepsy and neuropathic pain (peripheral or central); and the recommended dose for fibromyalgia was 300 to 450 mg/day.
854110|NCT01220128|B8|Baseline|Total|Total of all reporting groups
854111|NCT01220128|B7|Baseline|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854112|NCT01220128|B6|Baseline|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854113|NCT01220128|B5|Baseline|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854756|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
854114|NCT01220128|B4|Baseline|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854115|NCT01220128|B3|Baseline|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854116|NCT01220128|B2|Baseline|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854117|NCT01220128|B1|Baseline|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854118|NCT01220128|P7|Participant Flow|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854119|NCT01220128|P6|Participant Flow|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854332|NCT01219985|O1|Outcome|Ungated Per-lesion Sensitivity|Ungated PET images results were compared with pathological analyses
854120|NCT01220128|P5|Participant Flow|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854121|NCT01220128|P4|Participant Flow|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854122|NCT01220128|P3|Participant Flow|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854123|NCT01220128|P2|Participant Flow|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854124|NCT01220128|P1|Participant Flow|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854125|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854126|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854127|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854128|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854129|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854130|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854131|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854132|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854133|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854134|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854135|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854136|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854412|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854137|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854138|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854139|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854140|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854141|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854142|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854333|NCT01219985|E1|Reported Event|Investigation Arm|Patients included in the trial. n=50
854144|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854145|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854146|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854147|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854148|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854149|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854150|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854151|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854152|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854153|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854154|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854155|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854156|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854157|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854158|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854159|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854413|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854160|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854161|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854162|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854163|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854164|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854165|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854166|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854428|NCT01219855|E3|Reported Event|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854167|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854168|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854169|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854170|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854171|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854172|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854173|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854174|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854175|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854176|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854177|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854178|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854179|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854180|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854181|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854251|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854182|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854183|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854184|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854185|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854186|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854187|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854188|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854189|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
855263|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
854190|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854191|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854192|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854193|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854194|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854195|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854196|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854197|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854198|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854199|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854200|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854201|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854202|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854203|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854321|NCT01220128|E7|Reported Event|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854204|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854205|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854206|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854207|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854208|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854209|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854210|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854211|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854212|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854213|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854214|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854215|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854216|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854217|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854218|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854219|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854220|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854221|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854222|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854223|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854224|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854225|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854226|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854227|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854228|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854229|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854230|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854231|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854232|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854233|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854234|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854235|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854236|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854429|NCT01219855|E2|Reported Event|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854237|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854238|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854239|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854240|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854241|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854242|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854243|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854244|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854245|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854246|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854247|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854248|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854249|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854250|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854252|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854253|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854254|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854255|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854256|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854257|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854258|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854259|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
855264|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
854260|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854261|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854262|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854263|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854264|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854265|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854266|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854267|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854268|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854269|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854270|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854271|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854272|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854273|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854406|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854407|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854274|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854275|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854276|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854277|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854278|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854279|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854280|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854281|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854282|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854283|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854284|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854285|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854286|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854287|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854288|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854289|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854290|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854291|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854292|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854293|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854294|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854295|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854296|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854297|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
854298|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854299|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854300|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854301|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854302|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854303|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854304|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024AI and intravenous chemotherapy.
854305|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854306|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
855265|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
854307|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854308|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854309|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854310|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854311|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854312|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854313|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854314|NCT01220128|O7|Outcome|Cohort D-GSK2302024A-D14 Group|This group included patients with hormone receptor-positive and HER2 non-overexpressing breast cancer, who received GSK2302024A, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854315|NCT01220128|O6|Outcome|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854316|NCT01220128|O5|Outcome|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854317|NCT01220128|O4|Outcome|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854318|NCT01220128|O3|Outcome|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854319|NCT01220128|O2|Outcome|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854320|NCT01220128|O1|Outcome|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule
854322|NCT01220128|E6|Reported Event|Cohort C-Placebo Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of placebo, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule
854323|NCT01220128|E5|Reported Event|Cohort C-GSK2302024A Group|This group included patients with Human Epidermal Growth Factor Receptor 2 (HER2)-overexpressing breast cancer who received neoadjuvant trastuzumab (Herceptin) therapy, concurrently with administration of GSK2302024A, 5-Fluorouracil, Carboplatin AUC, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854324|NCT01220128|E4|Reported Event|Cohort B-Placebo Group|This group included breast cancer patients who received placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854325|NCT01220128|E3|Reported Event|Cohort B-GSK2302024A Group|This group included breast cancer patients who received GSK2302024A and intravenous chemotherapy.
854326|NCT01220128|E2|Reported Event|Cohort A-Placebo Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of placebo, 5-Fluorouracil, Cyclophosphamide, Docetaxel, Doxorubicin, Epirubicin and Paclitaxel according to the treatment schedule.
854327|NCT01220128|E1|Reported Event|Cohort A-GSK2302024A Group|This group included postmenopausal patients with hormone receptor-positive breast cancer who received aromatase inhibitor (AI) as neoadjuvant therapy, concurrently with administration of GSK2302024A according to the treatment schedule.
854328|NCT01219985|B1|Baseline|Investigation Arm|Patients included in the trial. n=50
854329|NCT01219985|P1|Participant Flow|Investigation Arm|Patients definitely included in the trial. All these patients underwent non-gated and gated PET/CT as well as hepatic surgery. In addition, histological analysis of the resected lesions were also obtained.
854330|NCT01219985|O1|Outcome|SUVmax Study|SUVmax measurement for each lesion in Ungated and CT-Based PET images. SUVmax was obtained automatically in a volume of interest encompassing the entire lesion
854331|NCT01219985|O2|Outcome|CT-Based Per-lesion Sensitivity|CT-Based PET images results were compared with pathological analyses
854334|NCT01219933|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854335|NCT01219933|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) intravenously (IV) once every 4 weeks and methotrexate (MTX) 7.5 to 25 mg per week (mg/week; per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received an oral glucocorticoid (GC; no product/dose limitation) until low disease activity (LDA; defined as Disease Activity Score Based on 28-Joint Count and C-reactive protein [DAS28-CRP] less than or equal to [≤]3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to methylprednisolone (MP) tablets, by mouth (PO). MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be greater than or equal to [≥]1 mg and ≤20 mg per day [mg/day]), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment
854336|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854337|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854338|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854339|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854414|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854340|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854341|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854342|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854379|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
854380|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
855266|NCT01217112|O5|Outcome|Placebo|Contains excipients only
854343|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854344|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854345|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854346|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854347|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854348|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854408|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854409|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854349|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854350|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854351|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854352|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854425|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854353|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854354|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854355|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854356|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854357|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854358|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854359|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854360|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854361|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854362|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854426|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854363|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854364|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854365|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854366|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854367|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854368|NCT01219933|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week per investigator's discretion, or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854369|NCT01219933|E2|Reported Event|Interventional Phase|All participants who maintained LDA from V2 to V3 were included in the interventional phase for reduction of GC. Once LDA achieved, GC was switched to MP tablets, PO. MP dose determined by recalculating original GC dose to obtain an equivalent MP dose (had to be ≥1 mg and ≤20 mg/day), which was administered for 4 weeks. If LDA continued after 4 weeks, MP dose was reduced over the following 6 months per protocol-defined dose reduction schedule to reach 0 mg within 6 months for a maximum duration of 7 months of MP treatment.
854370|NCT01219933|E1|Reported Event|Noninterventional Phase|Participants received tocilizumab 8 mg/kg IV once every 4 weeks and MTX 7.5 to 25 mg/week according to local standard of care and at the investigator's discretion (or without MTX if intolerant) for up to 13 months. Participants also received GC (no product/dose limitation) until LDA (defined as DAS28-CRP ≤3.2), up to a maximum of 6 months.
854371|NCT01219881|B3|Baseline|Total|Total of all reporting groups
854372|NCT01219881|B2|Baseline|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
854373|NCT01219881|B1|Baseline|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
854374|NCT01219881|P2|Participant Flow|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
854375|NCT01219881|P1|Participant Flow|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Desflurane : 5.4 to 7.4% desflurane"
854376|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
854377|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
854378|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
854427|NCT01219855|E4|Reported Event|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854381|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
854382|NCT01219881|O2|Outcome|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
854383|NCT01219881|O1|Outcome|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
854384|NCT01219881|E2|Reported Event|Sevoflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Sevoflurane.~Desflurane : 5.4 to 7.4% desflurane"
854385|NCT01219881|E1|Reported Event|Desflurane|"Comparing the effect on recovery time in patients undergoing urological cytoscope surgery under general anesthesia with a laryngeal mask airway (LMA) using Desflurane.~Sevoflurane : 1.4 to 2.5% Sevoflurane"
854386|NCT01219855|B6|Baseline|Total|Total of all reporting groups
854387|NCT01219855|B5|Baseline|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854388|NCT01219855|B4|Baseline|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854389|NCT01219855|B3|Baseline|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854390|NCT01219855|B2|Baseline|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854391|NCT01219855|B1|Baseline|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854392|NCT01219855|P5|Participant Flow|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854393|NCT01219855|P4|Participant Flow|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854394|NCT01219855|P3|Participant Flow|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854395|NCT01219855|P2|Participant Flow|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854396|NCT01219855|P1|Participant Flow|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854397|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854398|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854399|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854400|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854401|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854402|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854403|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854404|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854405|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854415|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854416|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854417|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854418|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854419|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854420|NCT01219855|O2|Outcome|Cohort 1: CTAP101 Capsules 90µg|Cohort 1 CTAP101 Capsules - 90µg: 90µg of CTAP101 capsules given once daily for 42 days.
854421|NCT01219855|O1|Outcome|Cohort 1: CTAP101 Capsules 60µg|Cohort 1 CTAP101 Capsules- 60µg: 60µg of CTAP101 capsules given once daily for 42 days.
854422|NCT01219855|O5|Outcome|Cohort 2: Sugar Capsule|Cohort 2 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854423|NCT01219855|O4|Outcome|Cohort 2: CTAP101 Capsules 30µg|Cohort 2 CTAP101 Capsules - 30µg: 30µg of CTAP101 capsules given once daily for 42 days.
854424|NCT01219855|O3|Outcome|Cohort 1: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854430|NCT01219855|E1|Reported Event|Cohorts 1,2: Sugar Capsule|Cohort 1 Matching Sugar Capsule: Placebo capsules given once daily for 42 days.
854431|NCT01219777|B1|Baseline|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
854432|NCT01219777|P1|Participant Flow|Carboplatin + Weekly Paclitaxel and Bevacizumab|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
854433|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
854434|NCT01219777|O1|Outcome|Arm I|"Chemotherapy Cycles 1-3: After study enrollment all patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. The cycles will be administered every 21 days.~Chemotherapy Cycle 4: Enrolled patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
854435|NCT01219777|E1|Reported Event|Arm I|"Chemotherapy Cycles 1-3: All patients will receive 3 cycles of carboplatin, weekly paclitaxel and bevacizumab. Cycles will be administered every 21 days.~Chemotherapy Cycle 4: Patients will receive carboplatin and paclitaxel without bevacizumab for cycle 4. Radiologic imaging will be obtained pretreatment and after cycle 4.~Surgery: After 4 cycles of chemotherapy patients will be evaluated for surgical exploration. Patients who complete treatment with neoadjuvant chemotherapy and are medically fit, will undergo maximal tumor cytoreduction. Surgery should be undertaken at least 28 days after the administration of bevacizumab.~Post-Surgical Chemotherapy: Following surgery, chemotherapy will be at the discretion of the treating physician and will not be part of the study outcomes. There currently is no standard therapy for patients with ovarian cancer after undergoing interval debulking, therefore, this will be at the discretion of"
854436|NCT01219738|B1|Baseline|Asthma|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
854437|NCT01219738|P1|Participant Flow|All Study Participants|"asthmatic subject received different doses of inhaled budesonide~Budesonide: A single inhaled dose of 360ug budesonide from a DPI.~Budesonide: A single inhaled dose of 720ug budesonide from a DPI.~Budesonide: A single dose of 1440ug of the budesonide from DPI.~Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.~Placebo: A single inhaled dose of placebo from a DPI."
854439|NCT01219738|O4|Outcome|720ug of Budesonide 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
854440|NCT01219738|O3|Outcome|Budesonide 1440 ug|Budesonide: A single inhaled dose of 1440ug budesonide from a DPI.
854441|NCT01219738|O2|Outcome|Budesonide 720 ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
854442|NCT01219738|O1|Outcome|Budesonide 360 ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
854443|NCT01219738|O5|Outcome|Placebo|Placebo: A single inhaled dose of placebo from a DPI
854444|NCT01219738|O4|Outcome|Budesonide 720ug 4 Times|Budesonide: 720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
854445|NCT01219738|O3|Outcome|Budesonide 1440ug|Budesonide: A single dose of 1440ug of the budesonide from DPI.
854446|NCT01219738|O2|Outcome|Budesonide 720ug|Budesonide: A single inhaled dose of 720ug budesonide from a DPI.
854447|NCT01219738|O1|Outcome|Budesonide 360ug|Budesonide: A single inhaled dose of 360ug budesonide from a DPI.
854448|NCT01219738|E1|Reported Event|All Study Participants|Budesonide:was given in different doses
854449|NCT01219673|B9|Baseline|Total|Total of all reporting groups
855267|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
854450|NCT01219673|B8|Baseline|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854451|NCT01219673|B7|Baseline|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854452|NCT01219673|B6|Baseline|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
854453|NCT01219673|B5|Baseline|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
854454|NCT01219673|B4|Baseline|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
854455|NCT01219673|B3|Baseline|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
854456|NCT01219673|B2|Baseline|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
854457|NCT01219673|B1|Baseline|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
854458|NCT01219673|P8|Participant Flow|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854459|NCT01219673|P7|Participant Flow|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854460|NCT01219673|P6|Participant Flow|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
854461|NCT01219673|P5|Participant Flow|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
854462|NCT01219673|P4|Participant Flow|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
854463|NCT01219673|P3|Participant Flow|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
854464|NCT01219673|P2|Participant Flow|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
854465|NCT01219673|P1|Participant Flow|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
854466|NCT01219673|O8|Outcome|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854467|NCT01219673|O7|Outcome|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854468|NCT01219673|O6|Outcome|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
854469|NCT01219673|O5|Outcome|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
854470|NCT01219673|O4|Outcome|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
854471|NCT01219673|O3|Outcome|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
854472|NCT01219673|O2|Outcome|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
854473|NCT01219673|O1|Outcome|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
854474|NCT01219673|E8|Reported Event|Armodafinil + Minocycline + Bupropion|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854475|NCT01219673|E7|Reported Event|Minocycline + Bupropion|"Minocycline 100 mg by muth two times a day.~Bupropion 100 mg by mouth two times a day.~Minocycline: 100 mg by mouth twice a day.~Bupropion: 100 mg by mouth twice a day."
854476|NCT01219673|E6|Reported Event|Armodafinil + Bupropion|"Armodafinil 150 mg by mouth once a day.~Bupropion 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Bupropion: 100 mg by mouth twice a day."
854477|NCT01219673|E5|Reported Event|Armodafinil + Minocycline|"Armodafinil 150 mg by mouth once a day.~Minocycline 100 mg by mouth two times a day.~Armodafinil: 150 mg by mouth once a day.~Minocycline: 100 mg by mouth twice a day."
854757|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
854478|NCT01219673|E4|Reported Event|Bupropion|"Bupropion 100 mg by mouth two times a day.~Bupropion: 100 mg by mouth twice a day."
854479|NCT01219673|E3|Reported Event|Minocycline|"Minocycline 100 mg by muth two times a day.~Minocycline: 100 mg by mouth twice a day."
854480|NCT01219673|E2|Reported Event|Armodafinil|"Armodafinil 150 mg by mouth once a day.~Armodafinil: 150 mg by mouth once a day."
854481|NCT01219673|E1|Reported Event|Placebo|"Placebo by mouth 2 times every day.~Placebo: 1 by mouth twice a day."
854482|NCT01218997|B3|Baseline|Total|Total of all reporting groups
854483|NCT01218997|B2|Baseline|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
854484|NCT01218997|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
854485|NCT01218997|P2|Participant Flow|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
854486|NCT01218997|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
854487|NCT01218997|O2|Outcome|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
854488|NCT01218997|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
854489|NCT01218997|E2|Reported Event|Oral Naltrexone 50 mg|Oral tablet taken once each day for up to 1 year.
854490|NCT01218997|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Administered once every 4 weeks via intramuscular (IM) injection for up to 1 year.
854491|NCT01218984|B4|Baseline|Total|Total of all reporting groups
854492|NCT01218984|B3|Baseline|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
854493|NCT01218984|B2|Baseline|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
854494|NCT01218984|B1|Baseline|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
854495|NCT01218984|P3|Participant Flow|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
854496|NCT01218984|P2|Participant Flow|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
854497|NCT01218984|P1|Participant Flow|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
854498|NCT01218984|O3|Outcome|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
854499|NCT01218984|O2|Outcome|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
854500|NCT01218984|O1|Outcome|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
854501|NCT01218984|E3|Reported Event|Medisorb Naltrexone 300 mg|Administered as a single gluteal IM injection
854502|NCT01218984|E2|Reported Event|Medisorb Naltrexone 150 mg|Administered as a single gluteal IM injection
854503|NCT01218984|E1|Reported Event|Medisorb Naltrexone 75 mg|Administered as a single gluteal intramuscular (IM) injection
854504|NCT01218971|B3|Baseline|Total|Total of all reporting groups
854505|NCT01218971|B2|Baseline|Medisorb Naltrexone 190 mg|
854506|NCT01218971|B1|Baseline|Medisorb Naltrexone 380 mg|
854507|NCT01218971|P2|Participant Flow|Medisorb Naltrexone 190 mg|
854508|NCT01218971|P1|Participant Flow|Medisorb Naltrexone 380 mg|
854509|NCT01218971|O2|Outcome|Medisorb Naltrexone 190 mg|
854510|NCT01218971|O1|Outcome|Medisorb Naltrexone 380 mg|
854511|NCT01218971|E6|Reported Event|190mg to 190mg|includes participants who received Medisorb naltrexone 190mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
854512|NCT01218971|E5|Reported Event|Placebo to 190mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 190mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
854513|NCT01218971|E4|Reported Event|380mg to 380mg|Includes participants who received Medisorb naltrexone 380mg in the base study and continued with the same dose strength in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
854514|NCT01218971|E3|Reported Event|Placebo to 380mg|Includes participants who received placebo in the base study but switched to Medisorb naltrexone 380mg in this extension. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
854515|NCT01218971|E2|Reported Event|Medisorb Naltrexone 190mg--Combined|Includes all participants who received Medisorb naltrexone 190mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
854516|NCT01218971|E1|Reported Event|Medisorb Naltrexone 380mg--Combined|Includes all participants who received Medisorb naltrexone 380mg in this extension study. Study drug was administered via intramuscular (IM) injection once every 4 weeks.
854517|NCT01218958|B4|Baseline|Total|Total of all reporting groups
854518|NCT01218958|B3|Baseline|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
854519|NCT01218958|B2|Baseline|Medisorb Naltrexone 380 mg|
854520|NCT01218958|B1|Baseline|Medisorb Naltrexone 190 mg|
854521|NCT01218958|P3|Participant Flow|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
854522|NCT01218958|P2|Participant Flow|Medisorb Naltrexone 380 mg|
854523|NCT01218958|P1|Participant Flow|Medisorb Naltrexone 190 mg|
854524|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
854525|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
854526|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
854527|NCT01218958|O3|Outcome|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
854528|NCT01218958|O2|Outcome|Medisorb Naltrexone 380 mg|
854529|NCT01218958|O1|Outcome|Medisorb Naltrexone 190 mg|
854530|NCT01218958|E3|Reported Event|Placebo Groups (Pooled)|Results for the two groups that received placebo were pooled together for reporting purposes.
854531|NCT01218958|E2|Reported Event|Medisorb Naltrexone 380 mg|
854532|NCT01218958|E1|Reported Event|Medisorb Naltrexone 190 mg|
854533|NCT01218867|B12|Baseline|Total|Total of all reporting groups
854534|NCT01218867|B11|Baseline|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854632|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854633|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854634|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854635|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854535|NCT01218867|B10|Baseline|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854536|NCT01218867|B9|Baseline|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854537|NCT01218867|B8|Baseline|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854538|NCT01218867|B7|Baseline|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854539|NCT01218867|B6|Baseline|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854540|NCT01218867|B5|Baseline|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854612|NCT01218646|B4|Baseline|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854758|NCT01218438|O2|Outcome|SUBCUTANEOUS 20%|
854541|NCT01218867|B4|Baseline|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854542|NCT01218867|B3|Baseline|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
855133|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
854543|NCT01218867|B2|Baseline|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854544|NCT01218867|B1|Baseline|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854545|NCT01218867|P11|Participant Flow|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854546|NCT01218867|P10|Participant Flow|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854547|NCT01218867|P9|Participant Flow|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854613|NCT01218646|B3|Baseline|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
854614|NCT01218646|B2|Baseline|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854615|NCT01218646|B1|Baseline|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854616|NCT01218646|P4|Participant Flow|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine.
854548|NCT01218867|P8|Participant Flow|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854549|NCT01218867|P7|Participant Flow|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854550|NCT01218867|P6|Participant Flow|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854551|NCT01218867|P5|Participant Flow|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854552|NCT01218867|P4|Participant Flow|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854553|NCT01218867|P3|Participant Flow|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854554|NCT01218867|P2|Participant Flow|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854555|NCT01218867|P1|Participant Flow|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) cluster of differentiation 8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854556|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854557|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854558|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854559|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854560|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854561|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854562|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854563|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854759|NCT01218438|O1|Outcome|INTRAVENOUS 10%|
854760|NCT01218438|O1|Outcome|Correction Factor|
854564|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854565|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854566|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
857621|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
854567|NCT01218867|O11|Outcome|Cohort 11 - 3 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854568|NCT01218867|O10|Outcome|Cohort 10 - 1 x 10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854569|NCT01218867|O9|Outcome|Cohort 9 - 3 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854570|NCT01218867|O8|Outcome|Cohort 8 - 1 x 10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854571|NCT01218867|O7|Outcome|Cohort 7 - 1 x 10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854572|NCT01218867|O6|Outcome|Cohort 6 - 3 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854573|NCT01218867|O5|Outcome|Cohort 5 - 1 x 10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854574|NCT01218867|O4|Outcome|Cohort 4 - 3 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
855134|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
854575|NCT01218867|O3|Outcome|Cohort 3 - 1 x 10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854576|NCT01218867|O2|Outcome|Cohort 2 - 3 x 10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854577|NCT01218867|O1|Outcome|Cohort 1 - 1 x 10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2(VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854578|NCT01218867|O11|Outcome|Cohort 11 - 3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854617|NCT01218646|P3|Participant Flow|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854618|NCT01218646|P2|Participant Flow|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854619|NCT01218646|P1|Participant Flow|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854620|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854579|NCT01218867|O10|Outcome|Cohort 10 - 1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854580|NCT01218867|O9|Outcome|Cohort 9 - 3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854581|NCT01218867|O8|Outcome|Cohort 8 - 1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854582|NCT01218867|O7|Outcome|Cohort 7 - 1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
855268|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
854583|NCT01218867|O6|Outcome|Cohort 6 - 3x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854584|NCT01218867|O5|Outcome|Cohort 5 - 1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854585|NCT01218867|O4|Outcome|Cohort 4 - 3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854586|NCT01218867|O3|Outcome|Cohort 3 - 1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854587|NCT01218867|O2|Outcome|Cohort 2 - 3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854588|NCT01218867|O1|Outcome|Cohort 1 - 1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) Chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854589|NCT01218867|E11|Reported Event|Cohort 11 (3x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854590|NCT01218867|E10|Reported Event|Cohort 10 (1x10(10) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
857622|NCT01212094|O1|Outcome|Placebo|Group administered placebo
854591|NCT01218867|E9|Reported Event|Cohort 9 (3x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854592|NCT01218867|E8|Reported Event|Cohort 8 (1x10(9) Cells (Low Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and low dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 72,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854593|NCT01218867|E7|Reported Event|Cohort 7 (1x10(9) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854594|NCT01218867|E6|Reported Event|Cohort 6 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854595|NCT01218867|E5|Reported Event|Cohort 5 (1x10(8) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854596|NCT01218867|E4|Reported Event|Cohort 4 (3x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854597|NCT01218867|E3|Reported Event|Cohort 3 (1x10(7) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854598|NCT01218867|E2|Reported Event|Cohort 2 (3x10(6) Cells (High Dose IL-2)|"Anti-VEGFR2 CAR CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
855135|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
854599|NCT01218867|E1|Reported Event|Cohort 1 (1x10(6) Cells (High Dose IL-2)|"Anti-vascular endothelial growth factor receptor 2 (VEGFR2) chimeric T cell receptor (CAR) CD8 plus PBL: Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)~Cyclophosphamide: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr~Aldesleukin: Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)~Fludarabine: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days"
854600|NCT01218802|B3|Baseline|Total|Total of all reporting groups
854601|NCT01218802|B2|Baseline|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
854602|NCT01218802|B1|Baseline|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
854603|NCT01218802|P2|Participant Flow|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
854604|NCT01218802|P1|Participant Flow|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
854605|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
854606|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
854607|NCT01218802|O2|Outcome|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
854608|NCT01218802|O1|Outcome|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
854609|NCT01218802|E2|Reported Event|Sugar Pill Placebo|"Participants will take a placebo that appears on the exterior to be the same as active drug. They will take one capsule daily.~Placebo: participants will take a sugar pill daily for 96 weeks"
854610|NCT01218802|E1|Reported Event|Rosuvastatin|"Participants will take Rosuvastatin 10 mg. daily for 96 weeks~Rosuvastatin 10 mg. daily for 96 weeks: Participants will take Rosuvastatin 10 mg. daily for 96 weeks."
854611|NCT01218646|B5|Baseline|Total|Total of all reporting groups
854745|NCT01218438|O1|Outcome|Intravenous 10%|
854621|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854622|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854623|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854624|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854625|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854626|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854627|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854628|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854629|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854630|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854631|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854636|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854637|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854638|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854639|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854640|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854641|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854642|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854643|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854644|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854645|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854646|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854647|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854648|NCT01218646|O4|Outcome|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854649|NCT01218646|O3|Outcome|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854650|NCT01218646|O2|Outcome|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854651|NCT01218646|O1|Outcome|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854652|NCT01218646|E4|Reported Event|Group 4 (Licensed Trivalent Influenza Vaccine)|Participants aged 18 to less than 65 years who received the Licensed 2010-2011 Trivalent Influenza Vaccine
854653|NCT01218646|E3|Reported Event|Group 3 (Licensed Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the received the Licensed 2010-2011 Trivalent Influenza Vaccine
854654|NCT01218646|E2|Reported Event|Group 2 (Investigational Trivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Trivalent Influenza Vaccine
854655|NCT01218646|E1|Reported Event|Group 1 (Investigational Quadrivalent Influenza Vaccine)|Participants aged 65 years and older who received the Investigational Quadrivalent Influenza Vaccine
854656|NCT01218594|B1|Baseline|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
854657|NCT01218594|P1|Participant Flow|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
854658|NCT01218594|O1|Outcome|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
854659|NCT01218594|E1|Reported Event|Endostar Plus CCRT|Patients received Endostar (7.5 mg/m2/d) through 7 days at weeks 1, 3, 5, and 7, and two cycles of docetaxel (65 mg/m2) and cisplatin (65 mg/m2) on days 8 and 36, with concurrent thoracic radiation at 60~66 Gy.
854660|NCT01218477|B5|Baseline|Total|Total of all reporting groups
854746|NCT01218438|O2|Outcome|Subcutaneous 20%|
854747|NCT01218438|O1|Outcome|Intravenous 10%|
854748|NCT01218438|O2|Outcome|Subcutaneous 20%|
854661|NCT01218477|B4|Baseline|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854662|NCT01218477|B3|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854663|NCT01218477|B2|Baseline|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), plus BMS-833923, 50 mg, QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854664|NCT01218477|B1|Baseline|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
854665|NCT01218477|P4|Participant Flow|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854666|NCT01218477|P3|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854667|NCT01218477|P2|Participant Flow|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg QD
854668|NCT01218477|P1|Participant Flow|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
854669|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854670|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID|Participants received BMS-833923, 100 mg twice daily (BID), for 7 days, followed by dasatinib, 100/140 mg once daily (QD)
854671|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
854672|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
854673|NCT01218477|O4|Outcome|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days, then once daily (QD), plus dasatinib, 100 /140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854674|NCT01218477|O3|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatinib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854675|NCT01218477|O2|Outcome|Dasatinib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase) plus BMS-833923, 50 mg, QD
854676|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD), depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
854677|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
854678|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
854679|NCT01218477|O1|Outcome|Dasatinib, 100/140 mg QD, Plus BMS-833923, 50-200 BID/QD|Participants received BMS-833923 + dasatinib at 1 of 4 dosing levels: Dasatinib, 100 mg/140 mg QD, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase); BMS-833923, 50 mg once daily (QD) + dasatinib, 100 mg/140 mg QD; BMS-833923, 100 mg twice daily (BID) for 7 days, then 100 mg QD + dasatinib 100 mg/140 mg QD; or BMS-833923, 200 mg BID for 7 days, then 200 mg QD + dasatinib 100 mg/140 mg QD
854680|NCT01218477|E4|Reported Event|Dasatinib, 100 /140 mg QD+ BMS-833923, 200 mg BID/QD|Participants received BMS-833923, 200 mg twice daily (BID) for 7 days then 200 mg once daily (QD) plus dasatinib, 100 /140 mg QD), depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854681|NCT01218477|E3|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 100 mg BID/QD|Participants received BMS-833923, 100 mg twice daily (BID) for 7 days then once daily (QD) + dasatanib, 100/140 mg QD, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854682|NCT01218477|E2|Reported Event|Dasatanib, 100/140 mg QD + BMS-833923, 50 mg QD|Participants received dasatanib, 100/140 mg once daily (QD), as oral tablets plus BMS-833923, 50 mg, QD (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854683|NCT01218477|E1|Reported Event|Dasatinib, 100/140 mg QD|Participants received dasatinib, 100/140 mg once daily (QD) (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
854749|NCT01218438|O1|Outcome|Intravenous 10%|
854684|NCT01218438|B1|Baseline|Study Epochs 1-4|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.~EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854685|NCT01218438|P1|Participant Flow|Study Participants|"EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.~EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854686|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
855136|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
854687|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854688|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854689|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854690|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854691|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854692|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854693|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854694|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854695|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854696|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854697|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854698|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854699|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854700|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854701|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854702|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854703|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854704|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854750|NCT01218438|O2|Outcome|Subcutaneous 20%|
854751|NCT01218438|O1|Outcome|Intravenous 10%|
854705|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854706|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854707|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854708|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854709|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854710|NCT01218438|O6|Outcome|CHANGE END EPOCH 1 TO END EPOCH 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854711|NCT01218438|O5|Outcome|CHANGE END EPOCH 1 TO END EPOCH 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854712|NCT01218438|O4|Outcome|END OF STUDY EPOCH 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854713|NCT01218438|O3|Outcome|END OF STUDY EPOCH 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
855137|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
854714|NCT01218438|O2|Outcome|END OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854715|NCT01218438|O1|Outcome|START OF STUDY EPOCH 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854716|NCT01218438|O6|Outcome|Change End of Epoch 1 to End of Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854717|NCT01218438|O5|Outcome|Change End of Epoch 1 to End of Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854718|NCT01218438|O4|Outcome|End of Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854719|NCT01218438|O3|Outcome|End of Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854720|NCT01218438|O2|Outcome|End of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854721|NCT01218438|O1|Outcome|Start of Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854722|NCT01218438|O6|Outcome|Change End Epoch 1 to End Epoch 4|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854723|NCT01218438|O5|Outcome|Change End Epoch 1 to End Epoch 3|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study. Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854724|NCT01218438|O4|Outcome|End of Study Epoch 4|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3.
854725|NCT01218438|O3|Outcome|End of Study Epoch 3|Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.
854726|NCT01218438|O2|Outcome|End of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854727|NCT01218438|O1|Outcome|Start of Study Epoch 1|Epoch 1 (13 weeks): Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854728|NCT01218438|O2|Outcome|Subcutaneous 20%|
854729|NCT01218438|O1|Outcome|Intravenous 10%|
854730|NCT01218438|O2|Outcome|Subcutaneous 20%|
854731|NCT01218438|O1|Outcome|Intravenous 10%|
854732|NCT01218438|O2|Outcome|Subcutaneous 20%|
854733|NCT01218438|O1|Outcome|Intravenous 10%|
854734|NCT01218438|O2|Outcome|Subcutaneous 20%|
854735|NCT01218438|O1|Outcome|Intravenous 10%|
854736|NCT01218438|O2|Outcome|Subcutaneous 20%|
854737|NCT01218438|O1|Outcome|Intravenous 10%|
854738|NCT01218438|O2|Outcome|Subcutaneous 20%|
854739|NCT01218438|O1|Outcome|Intravenous 10%|
854740|NCT01218438|O2|Outcome|Subcutaneous 20%|
854741|NCT01218438|O1|Outcome|Intravenous 10%|
854742|NCT01218438|O2|Outcome|Subcutaneous 20%|
854743|NCT01218438|O1|Outcome|Intravenous 10%|
854744|NCT01218438|O2|Outcome|Subcutaneous 20%|
854761|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854762|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854763|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854764|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
857828|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
854765|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854766|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854767|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854768|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854769|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854770|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854771|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854772|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854773|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20%, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854774|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20%, 145% of IGIV 10%|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854775|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854776|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 WeeksOverall Study Arm|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854777|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854778|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854779|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854780|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854904|NCT01218100|P4|Participant Flow|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
854781|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854782|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854783|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854784|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854925|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
854785|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854786|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854787|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854788|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854789|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854790|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854791|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854792|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854793|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854794|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854795|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Week|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854796|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854797|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854798|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854799|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854800|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854801|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously
854802|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1. Immune globulin administered subcutaneously (IGSC)
854803|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
854804|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study. Immune globulin administered intravenously (IGIV)
855138|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
854805|NCT01218438|O4|Outcome|Study Epoch 4: IGSC 20 %, Individualized Dose|Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion. Immune globulin administered subcutaneously (IGSC)
854806|NCT01218438|O3|Outcome|Study Epoch 2: IGSC 20 %, 145 % of IGIV 10 %|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Immune globulin administered subcutaneously (IGSC)"
854807|NCT01218438|O2|Outcome|Study Epoch 1: IGIV 10% Every 4 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 4 weeks at same monthly equivalent dose as prior to the study.~Immune globulin administered intravenously (IGIV)"
854808|NCT01218438|O1|Outcome|Study Epoch 1: IGIV 10% Every 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 weeks at same monthly equivalent dose as prior to the study.~Immune globulin administered intravenously (IGIV)"
854809|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854810|NCT01218438|O1|Outcome|Overall Study Arm|
854811|NCT01218438|O1|Outcome|Overall Study Arm|
854812|NCT01218438|O5|Outcome|SC 20% Individualized 1 Week|
854813|NCT01218438|O4|Outcome|SC 20% Adjusted 1 Week|
854814|NCT01218438|O3|Outcome|SC 20% 145% IV 1 Week|
854815|NCT01218438|O2|Outcome|IV 10% 4 Weeks|
854816|NCT01218438|O1|Outcome|IV 10% 3 Weeks|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854817|NCT01218438|O1|Outcome|Study Epochs 1-4|"Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.~Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854818|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854819|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
866318|NCT01188538|E1|Reported Event|Epiduo Gel|
854820|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"Epoch 2 (12-16 weeks): PK assessment (in first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated subcutaneously every 7 days at a dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~Epoch 3 (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~Epoch 4 (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854821|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|Epoch 1 (13 weeks): Pharmacokinetic (PK) assessment at 2nd to last infusion (in all participants ≥12 years of age). Participants will be treated intravenously once every 3 or 4 weeks at same monthly equivalent dose as prior to the study.
854839|NCT01218308|B1|Baseline|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
855020|NCT01217944|B1|Baseline|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
854822|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854823|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
854824|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854825|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
854826|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854827|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
854828|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854829|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
854830|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854831|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
854855|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854832|NCT01218438|O2|Outcome|Subcutaneous 20% - Epochs 2 Thru 4|"EPOCH 2: (12-16 weeks): PK (first 15 participants ≥12 years of age) at 9th infusion to determine adjusted dose for Epoch 3 and individually adapted dose for Epoch 4. Participants will be treated with immune globulin administered subcutaneously (IGSC), 20% every 7 days at dose of IGSC, 20% that is 145% of the weekly equivalent of the IV dose in Epoch 1.~EPOCH 3: (12 weeks): Participants will be treated subcutaneously every 7 days using the adjusted dose determined in Epoch 2. The individually adapted dose for use in Epoch 4 will also be determined.~EPOCH 4: (40 weeks): Participants will be treated subcutaneously once every week at the individually adapted dose determined in Epoch 3. PK assessment at 17th infusion."
854833|NCT01218438|O1|Outcome|Intravenous 10% - Epoch 1|- EPOCH 1: (13 weeks): Pharmacokinetics (PK) at 2nd to last infusion (participants ≥12 years of age). Participants will be treated with immune globulin administered intravenously (IGIV), 10% once every 3 or 4 weeks at same monthly equivalent dose as prior to study.
854834|NCT01218438|O1|Outcome|Study Participants|
854835|NCT01218438|E2|Reported Event|Study Epochs 2-4: Subcutaneous 20% Treatment|
854836|NCT01218438|E1|Reported Event|Study Epoch 1: Intravenous 10% Treatment|
854837|NCT01218308|B3|Baseline|Total|Total of all reporting groups
854838|NCT01218308|B2|Baseline|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854918|NCT01218100|E2|Reported Event|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
854919|NCT01218100|E1|Reported Event|Placebo|Placebo group - starting dose is placebo
854840|NCT01218308|P2|Participant Flow|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854841|NCT01218308|P1|Participant Flow|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854842|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854843|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854844|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854845|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854846|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854847|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854848|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854849|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854850|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854851|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854852|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854853|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854854|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
855232|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
854856|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854857|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854858|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854859|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854860|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854861|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854862|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854863|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854864|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854865|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854866|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854867|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854868|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854869|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854870|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854871|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854872|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854873|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854874|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854875|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854876|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854877|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854878|NCT01218308|O2|Outcome|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854879|NCT01218308|O1|Outcome|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854880|NCT01218308|E2|Reported Event|Havrix Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of Havrix™ vaccine at Day 0 and, if unprimed, 2 doses of Havrix™ vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854920|NCT01218087|B3|Baseline|Total|Total of all reporting groups
854921|NCT01218087|B2|Baseline|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
857829|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
854881|NCT01218308|E1|Reported Event|FluLaval® Quadrivalent Group|Subjects between 3 and 8 years of age at the time of first vaccination received, if primed, 1 dose of FluLaval® Quadrivalent vaccine at Day 0 and, if unprimed, 2 doses of FluLaval® Quadrivalent vaccine at Days 0 and 28. The vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
854882|NCT01218243|B3|Baseline|Total|Total of all reporting groups
854883|NCT01218243|B2|Baseline|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854884|NCT01218243|B1|Baseline|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854885|NCT01218243|P2|Participant Flow|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854886|NCT01218243|P1|Participant Flow|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854887|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854888|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854889|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854902|NCT01218100|B2|Baseline|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
854903|NCT01218100|B1|Baseline|Placebo|Placebo group - starting dose is placebo
854890|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854891|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854922|NCT01218087|B1|Baseline|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant
854923|NCT01218087|P2|Participant Flow|Moldable Positioner Device|Moldable positioner device was used 24/24 hours as a comparison to the cranial cup and moldable positioner study arm.
854924|NCT01218087|P1|Participant Flow|Cranial Cup Device|The cranial cup device was used 12/24 hours and the moldable positioner device was used for positioning infants the remainder of the 24 hours.
854892|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854893|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854894|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854895|NCT01218243|O2|Outcome|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854896|NCT01218243|O1|Outcome|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854897|NCT01218243|E2|Reported Event|Non-acupoint|"Take the place 2 cun far from BL33 on the outside horizontally as the non-point. Needle on the non-point for 60-80mm with a 45°angle. A feeling of soreness and distension will be felt .Needle with a 100-125mm long needle without lifting, thrusting or rotating.Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854898|NCT01218243|E1|Reported Event|Acupoint|"Needle on bilateral BL33 60-80 mm with a 45°angle.A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.~BL33 is an acupuncture point in the Bladder Meridian.Cun is the unit of measurement used in acupuncture, and 1 cun is defined as the distance across the uppermost joint of the thumb of the person being treated."
854899|NCT01218100|B5|Baseline|Total|Total of all reporting groups
854900|NCT01218100|B4|Baseline|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
854901|NCT01218100|B3|Baseline|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
866319|NCT01188499|B6|Baseline|Total|Total of all reporting groups
854905|NCT01218100|P3|Participant Flow|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
854906|NCT01218100|P2|Participant Flow|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
854907|NCT01218100|P1|Participant Flow|Placebo|Placebo group - starting dose is placebo
854908|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
854909|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
854910|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
854911|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
854912|NCT01218100|O4|Outcome|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
854913|NCT01218100|O3|Outcome|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
854914|NCT01218100|O2|Outcome|Nebivolol + Lisinopril (Combination)|Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
854915|NCT01218100|O1|Outcome|Placebo|Placebo group - starting dose is placebo
854916|NCT01218100|E4|Reported Event|Lisinopril|Lisinopril monotherapy group - starting dose level lisinopril 10mg
854917|NCT01218100|E3|Reported Event|Nebivolol|Nebivolol monotherapy group - starting dose level nebivolol 5mg
855269|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
854926|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
854927|NCT01218087|O2|Outcome|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
854928|NCT01218087|O1|Outcome|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
854929|NCT01218087|E2|Reported Event|Moldable Positioner Device|moldable positioner device: This positioning device was used 24/24 hours as a comparison to the cranial cup device.
854930|NCT01218087|E1|Reported Event|Cranial Cup Device|cranial cup device: The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in the infant. Although infants in this arm did use the moldable positioner, they were analyzed separately from the comparison group.
854931|NCT01218009|B3|Baseline|Total|Total of all reporting groups
854932|NCT01218009|B2|Baseline|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854933|NCT01218009|B1|Baseline|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854934|NCT01218009|P2|Participant Flow|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854935|NCT01218009|P1|Participant Flow|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854936|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854937|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854938|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854939|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854940|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854941|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854942|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854943|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854944|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854945|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
855021|NCT01217944|P3|Participant Flow|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
854946|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854947|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854948|NCT01218009|O2|Outcome|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854949|NCT01218009|O1|Outcome|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854950|NCT01218009|E2|Reported Event|Placebo Spiromax|Placebo delivered using a multi-dose dry powder inhaler (Spiromax) as 2 inhalations four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854951|NCT01218009|E1|Reported Event|Albuterol Spiromax|Albuterol multi-dose dry powder inhaler (Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period. Participants then continue into the 40 week open-label period in which they take albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg /inhalation as required (PRN).
854952|NCT01217957|B6|Baseline|Total|Total of all reporting groups
854953|NCT01217957|B5|Baseline|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854954|NCT01217957|B4|Baseline|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854955|NCT01217957|B3|Baseline|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854956|NCT01217957|B2|Baseline|Phase 1 :Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854957|NCT01217957|B1|Baseline|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854958|NCT01217957|P5|Participant Flow|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855119|NCT01217801|E2|Reported Event|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet AUC
854959|NCT01217957|P4|Participant Flow|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854960|NCT01217957|P3|Participant Flow|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854961|NCT01217957|P2|Participant Flow|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855022|NCT01217944|P2|Participant Flow|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855139|NCT01217749|E3|Reported Event|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
854962|NCT01217957|P1|Participant Flow|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854963|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854964|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854965|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854966|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854967|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854968|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854969|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854970|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854971|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
855047|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
854972|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854973|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854974|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854975|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854976|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854977|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854978|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854979|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
854980|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854981|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854982|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854983|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854984|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854985|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855227|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
854986|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854987|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854988|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854989|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855023|NCT01217944|P1|Participant Flow|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
854990|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854991|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854992|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854993|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854994|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854995|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854996|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854997|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854998|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
854999|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855048|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855000|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855001|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855002|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855003|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855024|NCT01217944|O1|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855025|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855004|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855005|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0 mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23 mg/m^2 in Phase 1.
855006|NCT01217957|O1|Outcome|Phase 2 :Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855007|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855008|NCT01217957|O1|Outcome|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855009|NCT01217957|O2|Outcome|Phase 2: Ixazomib 4.0mg/2.23 + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once, on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once, on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Includes 3 participants who received 2.23. mg/m^2 in Phase 1.
855010|NCT01217957|O1|Outcome|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855011|NCT01217957|O4|Outcome|Phase 1: Ixazomib 3.95 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855012|NCT01217957|O3|Outcome|Phase 1: Ixazomib 2.97 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.97 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle. for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.97 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855049|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
878147|NCT01153620|P1|Participant Flow|Ringer's Solution|
855013|NCT01217957|O2|Outcome|Phase 1: Ixazomib 2.23 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 2.23 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 2.23 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855014|NCT01217957|O1|Outcome|Phase 1: Ixazomib 1.68 mg/m^2 + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855015|NCT01217957|E2|Reported Event|Phase 2: Ixazomib 4.0 mg + Lenalidomide + Dexamethasone|In phase 2, ixazomib 4.0 mg fixed dose, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 4.0 mg fixed dose, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855016|NCT01217957|E1|Reported Event|Phase 1: Ixazomib + Lenalidomide + Dexamethasone|In phase 1, ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once, on Days 1, 8 and 15; plus dexamethasone 40 mg, tablets, orally, once on Days 1, 8, 15 and 22; and lenalidomide 25 mg, capsules, orally, once on Days 1 through 21 of a 28-day cycle for up to 12 cycles. Cycle 13 and beyond, single agent ixazomib 1.68, 2.23, 2.97 or 3.95 mg/m^2, capsules, orally, once on Days 1, 8 and 15 of a 28-day cycle until disease progression or unacceptable toxicity.
855017|NCT01217944|B4|Baseline|Total|Total of all reporting groups
855018|NCT01217944|B3|Baseline|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855019|NCT01217944|B2|Baseline|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855248|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855026|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855027|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855028|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855029|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855030|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855031|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855032|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855033|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855034|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855035|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855036|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855037|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855038|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855039|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855040|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855041|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855042|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855043|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855044|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855045|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855046|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855228|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855050|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855051|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855052|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855053|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855054|NCT01217944|O3|Outcome|Verteporfin PDT|Participants received active vPDT on day 1. From month 3 onwards participants could receive ranibizumab, vPDT or a combination of the two if needed.
855055|NCT01217944|O2|Outcome|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855056|NCT01217944|O1|Outcome|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855057|NCT01217944|E4|Reported Event|Visudyne PDT: Grp III Without 0.5mg Ranibizumab From Month 3|After month 3 participants did not receive active ranibizumab
855058|NCT01217944|E3|Reported Event|Visudyne PDT: Grp III With 0.5mg Ranibizumab From Month 3|After month 3 participants received active ranibizumab, active vPDT or a combination of the two if needed.
855059|NCT01217944|E2|Reported Event|0.5mg Ranibizumab Driven by Disease Activity|Participants received active ranibizumab on day 1. Thereafter they received ranibizumab treatment based on disease activity criteria
855060|NCT01217944|E1|Reported Event|0.5 mg Ranibizumab Driven by Stabilization Criteria|Participants received ranibizumab on day 1 and month 1. Thereafter they received ranibizumab based on stabilization criteria for visual acuity (VA).
855061|NCT01217892|B5|Baseline|Total|Total of all reporting groups
855062|NCT01217892|B4|Baseline|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
855063|NCT01217892|B3|Baseline|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855064|NCT01217892|B2|Baseline|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855065|NCT01217892|B1|Baseline|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855066|NCT01217892|P4|Participant Flow|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
855067|NCT01217892|P3|Participant Flow|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855068|NCT01217892|P2|Participant Flow|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855069|NCT01217892|P1|Participant Flow|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855070|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
855071|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855072|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855073|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855074|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
855075|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855076|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855077|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855078|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
855079|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855080|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855081|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855082|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
855083|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855084|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855085|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855086|NCT01217892|O4|Outcome|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
855087|NCT01217892|O3|Outcome|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855088|NCT01217892|O2|Outcome|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855089|NCT01217892|O1|Outcome|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855090|NCT01217892|E4|Reported Event|Placebo Plus Metformin|Placebo plus Metformin, oral, twice daily, >=1500mg total daily dose
878700|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
855091|NCT01217892|E3|Reported Event|Dapagliflozin 10mg OD Plus Metformin|Dapagliflozin 10mg, oral, once daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855092|NCT01217892|E2|Reported Event|Dapagliflozin 5mg BID Plus Metformin|Dapagliflozin 5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855093|NCT01217892|E1|Reported Event|Dapagliflozin 2.5mg BID Plus Metformin|Dapagliflozin 2.5mg, oral, twice daily plus Metformin, oral, twice daily, >=1500mg total daily dose
855094|NCT01217840|B3|Baseline|Total|Total of all reporting groups
855095|NCT01217840|B2|Baseline|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments. Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
855096|NCT01217840|B1|Baseline|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
855097|NCT01217840|P2|Participant Flow|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
855132|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO daily was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
855098|NCT01217840|P1|Participant Flow|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
855099|NCT01217840|O2|Outcome|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
855100|NCT01217840|O1|Outcome|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
855101|NCT01217840|E2|Reported Event|Placebo|"Subjects were assigned to receive two observed doses of placebo, given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Interventions: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Placebo: Placebo pill - 3 pills every 12 weeks for total of 24 weeks"
855102|NCT01217840|E1|Reported Event|Vitamin D|"Subjects were assigned to receive two observed doses of vitamin D2 (150,000 IU ergocalciferol, Barr Laboratories and Winthrop (Sanofi-Aventis)), given at baseline and 12 weeks. Capsules were packaged by the hospital’s clinical trial pharmacist and were administered by study staff blinded to group assignments.~Intervention: Height, weight, and BMI were obtained at baseline, 12 weeks and 24 weeks~Drisdol (Ergocalciferol) Vitamin D2: Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks."
855103|NCT01217827|B3|Baseline|Total|Total of all reporting groups
855104|NCT01217827|B2|Baseline|Control|This group does not receive an intervention.
855105|NCT01217827|B1|Baseline|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
855106|NCT01217827|P2|Participant Flow|Control|This group does not receive an intervention.
855107|NCT01217827|P1|Participant Flow|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
855108|NCT01217827|O2|Outcome|Control|This group does not receive an intervention.
855109|NCT01217827|O1|Outcome|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
855110|NCT01217827|E2|Reported Event|Control|This group does not receive an intervention.
855111|NCT01217827|E1|Reported Event|Clinical Reminder|"Reminder of potential candidacy for an implantable cardioverter defibrillator. The reminder is placed in the medical record with copy to the primary provider and any cardiologist managing the patient.~Clinical Reminder"
855112|NCT01217801|B3|Baseline|Total|Total of all reporting groups
855113|NCT01217801|B2|Baseline|Ondanestron Orally Disintegrating Tablet|Ondanestron Orally Disintegrating Tablet (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Dissolving Filmstrip (8 mg); AUCs for each period will be calculated.
855114|NCT01217801|B1|Baseline|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip (8 mg) followed by a 7 day wash out and then administered Ondanestron Orally Disintegrating tablets (8 mg); AUCs for each period will be calculated.
855115|NCT01217801|P2|Participant Flow|Ondansetron Orally Disintegrating Tablet Then OD Film|Ondansetron Orally Disintegrating Tablet AUC Ondansetron 8 mg then 7 days then Ondansetron Orally Disintegrating Film 8 mg measure AUC
855116|NCT01217801|P1|Participant Flow|Ondansetron Orally Dissolving Filmstrip Then ODT|Ondansetron Orally Dissolving Filmstrip 8 mg then 7 days then Ondansetron Orally Disintegrating Tablet 8 mg measure AUC
855117|NCT01217801|O2|Outcome|Tablet|tablet AUC
855118|NCT01217801|O1|Outcome|Film|AUC film strip
855120|NCT01217801|E1|Reported Event|Ondanestron Orally Dissolving Filmstrip|Ondanestron Orally Dissolving Filmstrip AUC
855121|NCT01217749|B4|Baseline|Total|Total of all reporting groups
855122|NCT01217749|B3|Baseline|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
855123|NCT01217749|B2|Baseline|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
855124|NCT01217749|B1|Baseline|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
855125|NCT01217749|P3|Participant Flow|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
855126|NCT01217749|P2|Participant Flow|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
855127|NCT01217749|P1|Participant Flow|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
855128|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
855129|NCT01217749|O1|Outcome|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
855130|NCT01217749|O3|Outcome|Group 3|In Group 3, two cycles of ofatumumab IV were administered prior to the start of PCI-32765 420 mg PO daily
855131|NCT01217749|O2|Outcome|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
855249|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855140|NCT01217749|E2|Reported Event|Group 2|In Group 2, PCI-32765 420 mg PO daily was initiated concomitantly with ofatumumab IV (PCI-32765 initiated on Day 2 of Cycle 1)
855141|NCT01217749|E1|Reported Event|Group 1|In Group 1, PCI-32765 420 mg PO was administered daily for 1 cycle (28 days) before the start of ofatumumab IV dosing
855142|NCT01217606|B3|Baseline|Total|Total of all reporting groups
855143|NCT01217606|B2|Baseline|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
855144|NCT01217606|B1|Baseline|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
855145|NCT01217606|P2|Participant Flow|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
855146|NCT01217606|P1|Participant Flow|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks in the Initial Treatment Phase followed by a 9 month Masked Extension.
855147|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
855148|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
855149|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
855150|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
855151|NCT01217606|O2|Outcome|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
855152|NCT01217606|O1|Outcome|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
855153|NCT01217606|E2|Reported Event|Combigan®|Fixed Combination brimonidine tartrate/timolol ophthalmic solution (Combigan®). One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
855154|NCT01217606|E1|Reported Event|Triple Combination Therapy|Triple Combination Therapy with bimatoprost/brimonidine tartrate/timolol ophthalmic solution. One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
855155|NCT01217515|B4|Baseline|Total|Total of all reporting groups
855156|NCT01217515|B3|Baseline|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
855157|NCT01217515|B2|Baseline|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
855158|NCT01217515|B1|Baseline|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
855159|NCT01217515|P3|Participant Flow|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
855160|NCT01217515|P2|Participant Flow|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
855161|NCT01217515|P1|Participant Flow|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
855162|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
855229|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855163|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
855164|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
855165|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
855166|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
855167|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
855168|NCT01217515|O3|Outcome|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
855169|NCT01217515|O2|Outcome|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
855170|NCT01217515|O1|Outcome|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
855171|NCT01217515|E3|Reported Event|Placebo Cream|"2.5 cm placebo cream applied peri-anally three times daily for eight weeks.~Placebo : 3 times daily"
855172|NCT01217515|E2|Reported Event|Diltiazem Hydrochloride 4% Cream|"2.5 cm Diltiazem hydrochloride 4% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 4% cream : 3 times daily"
855250|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855173|NCT01217515|E1|Reported Event|Diltiazem Hydrochloride 2% Cream|"2.5 cm of Diltiazem hydrochloride 2% cream applied peri-anally three times daily for eight weeks.~Diltiazem hydrochloride 2% cream : 3 times daily"
855174|NCT01217476|B3|Baseline|Total|Total of all reporting groups
855175|NCT01217476|B2|Baseline|Placebo|Matching placebo spray
855176|NCT01217476|B1|Baseline|Trafermin|Trafermin 0.01% spray
855177|NCT01217476|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
855178|NCT01217476|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
855179|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
855180|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
855181|NCT01217476|O2|Outcome|Placebo|Matching placebo spray
855182|NCT01217476|O1|Outcome|Trafermin|Trafermin 0.01% spray
855183|NCT01217476|E2|Reported Event|Placebo|Matching placebo spray
855184|NCT01217476|E1|Reported Event|Trafermin|Trafermin 0.01% spray
855185|NCT01217463|B3|Baseline|Total|Total of all reporting groups
855186|NCT01217463|B2|Baseline|Placebo|Matching placebo spray
855187|NCT01217463|B1|Baseline|Trafermin|Trafermin 0.01% spray
855188|NCT01217463|P2|Participant Flow|Placebo|Matching placebo spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
855189|NCT01217463|P1|Participant Flow|Trafermin|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
855190|NCT01217463|O2|Outcome|Matching Placebo Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
855191|NCT01217463|O1|Outcome|Trafermin 0.01% Spray|Trafermin 0.01% spray: For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
855192|NCT01217463|O2|Outcome|Placebo|Matching placebo spray
855193|NCT01217463|O1|Outcome|Trafermin|Trafermin 0.01% spray
855194|NCT01217463|E2|Reported Event|Placebo|Matching placebo spray
855195|NCT01217463|E1|Reported Event|Trafermin|Trafermin 0.01% spray
855196|NCT01217411|B4|Baseline|Total|Total of all reporting groups
855197|NCT01217411|B3|Baseline|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in phase I.~Gamma-secretase/Notch signalling pathway inhibitor RO4929097: MTD Dosing cohorts: 5 mg, 10 mg and 20 mg given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
855230|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855198|NCT01217411|B2|Baseline|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo Whole-Brain Radiotherapy (WBRT) as in phase I and patients with =< 3 brain lesions undergo Stereotactic Radiosurgery (SRS) as in phase I.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
855199|NCT01217411|B1|Baseline|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
855200|NCT01217411|P3|Participant Flow|Arm II (WBRT or SRS and RO4929097)|"Patients with >= 4 brain lesions receive RO4929097 and undergo WBRT as in Phase I and patients with =< 3 brain lesions receive RO4929097 and undergo SRS as in Phase I.~Gamma-secretase/Notch signalling pathway inhibitor RO4929097: Maximum tolerated dose (MTD) derived from Phase I given orally (3 days on/4 days off continuous) 1 day prior to beginning WBRT or 2 days prior to SRS.~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
855251|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855252|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855201|NCT01217411|P2|Participant Flow|Arm I (WBRT or SRS)|"Patients with >= 4 brain lesions undergo WBRT as in Phase I and patients with =< 3 brain lesions undergo SRS as in Phase I.~Stereotactic radiosurgery (SRS): Undergo radiosurgery; 20 Gy for tumors up to 1cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions, and if overall patient status and tumor geometry amenable to this treatment modality~Whole-brain radiation therapy (WBRT): Undergo radiotherapy; 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for stereotactic radiosurgery"
855202|NCT01217411|P1|Participant Flow|Phase I MTD Arm|"RO4929097 starting dose oral 5 mg; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I Whole-Brain Radiotherapy (WBRT) + RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I Stereotactic Radiosurgery (SRS) + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS~For the SRS regiment: RO4929097 on Days 1-7 (no drug on days 8-14), weeks 1 and 2 only.~SRS: Radiosurgery 20 Gray (Gy) for tumors up to 1 cm diameter, 18 Gy for tumors from 1.1-2.5 cm, 16 Gy for tumors >2.5 cm for patients with 3 or fewer brain lesions. WBRT: Radiotherapy 30-40 Gy over 10-20 fractions for patients with 4 or more brain lesions, or who are otherwise not eligible or appropriate for SRS"
855203|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
855204|NCT01217411|O1|Outcome|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
855205|NCT01217411|E1|Reported Event|Phase I MTD Arm|"RO4929097 dose to be determined; Dosing cohorts: 5 mg, 10 mg and 20 mg~For patients with 4 or more lesions: Phase I WBRT+RO4929097; Begin RO4929097** (3 days on/4 days off continuous) 1 day prior to beginning WBRT~For patients with 3 or fewer lesions: Phase I SRS + RO4929097; Begin RO4929097** (3 days on/ 4 days off continuous) 2 days prior to SRS"
855206|NCT01217229|B1|Baseline|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
855207|NCT01217229|P1|Participant Flow|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
855208|NCT01217229|O1|Outcome|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
855209|NCT01217229|E1|Reported Event|PLX3397|PLX3397 : Capsules administered once or twice daily, continuous dosing, at 900 mg/day.
855210|NCT01217112|B6|Baseline|Total|Total of all reporting groups
855211|NCT01217112|B5|Baseline|Placebo|Contains excipients only
855212|NCT01217112|B4|Baseline|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855213|NCT01217112|B3|Baseline|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855214|NCT01217112|B2|Baseline|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855215|NCT01217112|B1|Baseline|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855216|NCT01217112|P5|Participant Flow|Placebo|Contains excipients only
855217|NCT01217112|P4|Participant Flow|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855218|NCT01217112|P3|Participant Flow|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855219|NCT01217112|P2|Participant Flow|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855220|NCT01217112|P1|Participant Flow|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855221|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855222|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855223|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855224|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855225|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855226|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855231|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855233|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855234|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855235|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855236|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855237|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855238|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855239|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855240|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855241|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855242|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855243|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855244|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855245|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855246|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855247|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855270|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855271|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855272|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855273|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855274|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855275|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855276|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855277|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855278|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855279|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855280|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855281|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855282|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855283|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855284|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855285|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855286|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855287|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855288|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855289|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855290|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855291|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855292|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855293|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855294|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855295|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855296|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855297|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855298|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855299|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855300|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855301|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855302|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855303|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855304|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855305|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855306|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855307|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855308|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855309|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855310|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855311|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855312|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855313|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855314|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855315|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855316|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855317|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855318|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855319|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855320|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855321|NCT01217112|O5|Outcome|Placebo|Contains excipients only
878853|NCT01151436|O1|Outcome|Hyaluronic Acid|
855322|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855323|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855324|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855325|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855326|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855327|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855328|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855329|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855330|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855331|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855332|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855333|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855334|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855335|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855336|NCT01217112|O5|Outcome|Placebo|Contains excipients only
857830|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
855337|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855338|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855339|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855340|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855341|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855342|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855343|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855344|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855345|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855346|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855347|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855348|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855349|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855350|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855351|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855352|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855353|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855354|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855355|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855356|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855357|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855358|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855359|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855360|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855361|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855362|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855363|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855364|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855365|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855366|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855367|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855368|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855369|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855370|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855371|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855372|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855373|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855374|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855375|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855376|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855377|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855378|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855379|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855380|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855381|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855382|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855383|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855384|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855385|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855386|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855387|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855388|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855389|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855390|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855391|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855392|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855393|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855394|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855395|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855396|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855397|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855398|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855399|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855400|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855401|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855402|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855403|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855404|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855405|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855406|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855407|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855408|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855409|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855410|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855411|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855412|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855413|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855414|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855415|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855416|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855417|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855418|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855419|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855420|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855421|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855422|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855423|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855424|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855425|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855426|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855427|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855428|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855429|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855430|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855431|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855432|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855433|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855434|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855435|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855436|NCT01217112|O5|Outcome|Placebo|Contains excipients only
855437|NCT01217112|O4|Outcome|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855438|NCT01217112|O3|Outcome|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855439|NCT01217112|O2|Outcome|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855440|NCT01217112|O1|Outcome|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855441|NCT01217112|E5|Reported Event|Placebo|Contains excipients only
855442|NCT01217112|E4|Reported Event|GWP42004 and Placebo|Contains GWP42004 5 mg and placebo (excipients only)
855443|NCT01217112|E3|Reported Event|GWP42003 and Placebo|Contains 100 mg GWP42003 and placebo (excipients only)
855444|NCT01217112|E2|Reported Event|20:1 GWP42003 : GWP42004|Contains 100 mg GWP42003 and 5 mg GWP42004
855445|NCT01217112|E1|Reported Event|1:1 GWP42003 : GWP42004|Contains 5 mg each of GWP42003 and GWP42004
855446|NCT01217073|B7|Baseline|Total|Total of all reporting groups
855447|NCT01217073|B6|Baseline|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855448|NCT01217073|B5|Baseline|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855449|NCT01217073|B4|Baseline|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855450|NCT01217073|B3|Baseline|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855451|NCT01217073|B2|Baseline|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855452|NCT01217073|B1|Baseline|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855453|NCT01217073|P8|Participant Flow|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
855454|NCT01217073|P7|Participant Flow|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly and placebo to metformin once daily for 66 weeks (extension period)
855455|NCT01217073|P6|Participant Flow|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855456|NCT01217073|P5|Participant Flow|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855457|NCT01217073|P4|Participant Flow|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855458|NCT01217073|P3|Participant Flow|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855459|NCT01217073|P2|Participant Flow|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855460|NCT01217073|P1|Participant Flow|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855494|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855495|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855461|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
855462|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855463|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855464|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855465|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855466|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855467|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
855468|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
855469|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
855470|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855471|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855472|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855473|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855474|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855475|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
855476|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
855477|NCT01217073|O6|Outcome|Placebo (Base)/Metformin (Extension)|Matching placebo to omarigliptin administered once weekly for 12 weeks (Base) followed by pioglitazone 30 mg administered once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension). Piogliatazone was removed by a protocol amendment and replaced with metformin starting dose 500 mg one daily up-titrated to 1000 mg twice daily.
855478|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)/25 mg (Extension)|Omarigliptin 25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855479|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)/25 mg (Extension)|Omarigliptin 10 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855480|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)/25 mg (Extension)|Omarigliptin 3 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855481|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)/25 mg (Extension)|Omarigliptin 1 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855482|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)/25 mg (Extension)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (Base) followed by omarigliptin 25 mg once weekly for 66 weeks (Extension)
855483|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
855484|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
855485|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855486|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855487|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855488|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855489|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855490|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855491|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855492|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855493|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855496|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855497|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
855498|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
855499|NCT01217073|O2|Outcome|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
855500|NCT01217073|O1|Outcome|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
855501|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855502|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855503|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855504|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855505|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855506|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855507|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855508|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855509|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855510|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855511|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855512|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855513|NCT01217073|O6|Outcome|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855514|NCT01217073|O5|Outcome|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855515|NCT01217073|O4|Outcome|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855516|NCT01217073|O3|Outcome|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855517|NCT01217073|O2|Outcome|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855518|NCT01217073|O1|Outcome|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855519|NCT01217073|E8|Reported Event|Placebo/Metformin (Extension)|Participants who received matching placebo to omarigliptin during the base study, received pioglitazone 30 mg once daily and matching placebo to omarigliptin once weekly for 66 weeks (Extension period). Participants were switched from pioglitazone to metformin starting at 500 mg once daily and titrated up to 1000 mg twice a day
855520|NCT01217073|E7|Reported Event|Pooled Omarigliptin (Extension)|Participants received omarigliptin 25 mg once weekly for 66 weeks (extension period)
855521|NCT01217073|E6|Reported Event|Placebo (Base)|Matching placebo to omarigliptin administered once weekly for 12 weeks (base period)
855522|NCT01217073|E5|Reported Event|Omarigliptin 25 mg (Base)|Omarigliptin 25 mg administered once weekly for 12 weeks (base period)
855523|NCT01217073|E4|Reported Event|Omarigliptin 10 mg (Base)|Omarigliptin 10 mg administered once weekly for 12 weeks (base period)
855524|NCT01217073|E3|Reported Event|Omarigliptin 3 mg (Base)|Omarigliptin 3 mg administered once weekly for 12 weeks (base period)
855525|NCT01217073|E2|Reported Event|Omarigliptin 1 mg (Base)|Omarigliptin 1 mg administered once weekly for 12 weeks (base period)
855526|NCT01217073|E1|Reported Event|Omarigliptin 0.25 mg (Base)|Omarigliptin 0.25 mg administered once weekly for 12 weeks (base period)
855527|NCT01216943|B1|Baseline|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
855595|NCT01216397|B1|Baseline|All Participants|Treatment with standard batch and side batch
855528|NCT01216943|P1|Participant Flow|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
855529|NCT01216943|O1|Outcome|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
855530|NCT01216943|E1|Reported Event|Triple Combination Therapy|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
855531|NCT01216761|B1|Baseline|Total Population|
855532|NCT01216761|P3|Participant Flow|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
855533|NCT01216761|P2|Participant Flow|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
855563|NCT01216631|P1|Participant Flow|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
857831|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
855534|NCT01216761|P1|Participant Flow|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
855535|NCT01216761|O3|Outcome|Povidone Iodine (PI)|10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI
855536|NCT01216761|O2|Outcome|Iodine Tincture (IT)|Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT
855537|NCT01216761|O1|Outcome|Chlorhexidine Gluconate (CHG_|2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG
855538|NCT01216761|E3|Reported Event|PI Then IT Then CHG|"10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG"
855539|NCT01216761|E2|Reported Event|IT Then CHG Then PI|"Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT~2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI"
855540|NCT01216761|E1|Reported Event|CHG Then PI Then IT|"2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS) -- CHG~10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS) -- PI~Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS) -- IT"
855541|NCT01216748|B1|Baseline|Controls|health-lifetime non-smokers were enrolled
855542|NCT01216748|P1|Participant Flow|All Study Participants|healthy lifetime non smokers were challenged with 4 respiratory manouvers: quiet breathing, hypocapnic hyperventilation, hypercapnic hyperventilation, and eucapnic hyperventilation in random order.
855543|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
855544|NCT01216748|O1|Outcome|Health Controls|Health lifetime non smokers were recruited.
855545|NCT01216748|E1|Reported Event|Health Controls|Health lifetime non smokers were recruited.
855546|NCT01216735|B3|Baseline|Total|Total of all reporting groups
855547|NCT01216735|B2|Baseline|Non-smokers|this group served as controls for baseline data. No intervention or treatment were assigned to this group.
855548|NCT01216735|B1|Baseline|Smokers|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
855549|NCT01216735|P2|Participant Flow|Placebo First, Then Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
855550|NCT01216735|P1|Participant Flow|Fluticasone First, Then Placebo|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI) or placebo. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI) or matching placebo"
855551|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Placebo: Placebo MDI"
855552|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
855553|NCT01216735|O2|Outcome|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Placebo: Placebo MDI"
855593|NCT01216410|E2|Reported Event|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855594|NCT01216410|E1|Reported Event|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855554|NCT01216735|O1|Outcome|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day administered as a metered dose inhaled (MDI)"
855555|NCT01216735|E2|Reported Event|Placebo|"The current smokers will be given a 3-week treatment course of inhaled placebo MDI. The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
855556|NCT01216735|E1|Reported Event|Fluticasone|"The current smokers will be given a 3-week treatment course of inhaled fluticasone (220 ug fluticasone twice a day administered as a MDI). The subjects and the investigators will be blinded to the random choice of inhaler.~Fluticasone: 220 ug twice a day for 3 weeks~Placebo: Placebo for 3 weeks"
855557|NCT01216631|B4|Baseline|Total|Total of all reporting groups
855558|NCT01216631|B3|Baseline|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
855559|NCT01216631|B2|Baseline|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
855560|NCT01216631|B1|Baseline|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
855561|NCT01216631|P3|Participant Flow|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
855562|NCT01216631|P2|Participant Flow|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
855858|NCT01215851|B7|Baseline|Total|Total of all reporting groups
855564|NCT01216631|O3|Outcome|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
855565|NCT01216631|O2|Outcome|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
855566|NCT01216631|O1|Outcome|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
855567|NCT01216631|E3|Reported Event|IV Infliximab|"intravenous infusions of infliximab given at 0, 2, 6 and 14 weeks at a dose of 5mg/kg (patient body weight)~Infliximab: intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14"
855568|NCT01216631|E2|Reported Event|IA Infliximab|"intra-articular injection of 100mg infliximab~Infliximab: intra-articular injection of 100mg infliximab given at baseline only"
855569|NCT01216631|E1|Reported Event|IA Steroid|"Intra-articular injection of steroid (80mg depomedrone)~methylprednisolone: intra-articular injection of methylprednisolone (80mg given at baseline only)"
855570|NCT01216410|B4|Baseline|Total|Total of all reporting groups
855571|NCT01216410|B3|Baseline|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855572|NCT01216410|B2|Baseline|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855573|NCT01216410|B1|Baseline|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855574|NCT01216410|P3|Participant Flow|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855575|NCT01216410|P2|Participant Flow|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855576|NCT01216410|P1|Participant Flow|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855577|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855578|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855579|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855580|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855581|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855582|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855583|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855584|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855585|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855586|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855587|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855588|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855589|NCT01216410|O3|Outcome|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855590|NCT01216410|O2|Outcome|Metoclopramide|Metoclopramide : Prophylactic Metoclopramide 10 mg given before spinal
855591|NCT01216410|O1|Outcome|Combination Group|"Metoclopramide and Ondansetron prophylaxis~Combination Group : Metoclopramide and ondansetron prophylaxis"
855592|NCT01216410|E3|Reported Event|Phenylephrine Infusion|"Prophylactic phenylephrine infusion and placebo antiemetics~Phenylephrine infusion : Prophylactic phenylephrine infusion after spinal"
855596|NCT01216397|P2|Participant Flow|Side Batch Then Standard Batch|Linagliptin/metformin FDC tablet from side batch, then Linagliptin/metformin FDC tablet from standard batch
855597|NCT01216397|P1|Participant Flow|Standard Batch Then Side Batch|Linagliptin/metformin FDC tablet from standard batch, then Linagliptin/metformin FDC tablet from side batch
855598|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855599|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855600|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855601|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855602|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855603|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855604|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855605|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855606|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855607|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855608|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855609|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855610|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855611|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855612|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855613|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855614|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855615|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855616|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855617|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855618|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855619|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855620|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855621|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855622|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855623|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855624|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855625|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855626|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855627|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855628|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855629|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855630|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855631|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855632|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855633|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855634|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855635|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855636|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855637|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855638|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855639|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855640|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855641|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855642|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855643|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855644|NCT01216397|O2|Outcome|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855645|NCT01216397|O1|Outcome|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855646|NCT01216397|E2|Reported Event|Side Batch|side batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855647|NCT01216397|E1|Reported Event|Standard Batch|standard batch of a 2.5 mg linagliptin/ 1000mg metformin FDC
855648|NCT01216319|B1|Baseline|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
855649|NCT01216319|P1|Participant Flow|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
855650|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
855651|NCT01216319|O1|Outcome|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
855652|NCT01216319|E1|Reported Event|Nipple Reconstruction Cylinder|Nipple reconstruction: Biodesign® Nipple Reconstruction Cylinder
855653|NCT01216241|B3|Baseline|Total|Total of all reporting groups
855654|NCT01216241|B2|Baseline|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
855655|NCT01216241|B1|Baseline|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
878854|NCT01151436|O1|Outcome|Hyaluronic Acid|
855656|NCT01216241|P2|Participant Flow|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
855657|NCT01216241|P1|Participant Flow|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
855658|NCT01216241|O2|Outcome|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
855659|NCT01216241|O1|Outcome|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
855660|NCT01216241|E2|Reported Event|Saline Placebo|"Saline solution~Saline Placebo : 50 ml normal saline once daily~Daptomycin : 8 mg/kg once daily"
855661|NCT01216241|E1|Reported Event|Daptomycin|"Daptomycin intravenous 8mg/kg once per day 5-10 days.~Daptomycin : 8 mg/kg once daily~Daptomycin : 8 MG/KG IV"
855662|NCT01216163|B4|Baseline|Total|Total of all reporting groups
855663|NCT01216163|B3|Baseline|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855664|NCT01216163|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855665|NCT01216163|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855666|NCT01216163|P3|Participant Flow|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855667|NCT01216163|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
857832|NCT01211145|E4|Reported Event|ZOMIG 5 mg|ZOMIG nasal spray
855668|NCT01216163|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855669|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855670|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855671|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855672|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855673|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855674|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855675|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855676|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855677|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855678|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855679|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855680|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855681|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855682|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855683|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855684|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855685|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855686|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855687|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855688|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855689|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855690|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855691|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855692|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855693|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855694|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855695|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855696|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855697|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855698|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855699|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855700|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855701|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855702|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855703|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855704|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855705|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855706|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855707|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855708|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855709|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855710|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855711|NCT01216163|O3|Outcome|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855712|NCT01216163|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855713|NCT01216163|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855714|NCT01216163|E3|Reported Event|Acetaminophen|Single oral dose of 2 acetaminophen (Extra Strength Tylenol) 500 mg tablets, equivalent to 1000 mg acetaminophen.
855715|NCT01216163|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
855716|NCT01216163|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
855717|NCT01216072|B3|Baseline|Total|Total of all reporting groups
855718|NCT01216072|B2|Baseline|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855719|NCT01216072|B1|Baseline|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855720|NCT01216072|P2|Participant Flow|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855721|NCT01216072|P1|Participant Flow|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855722|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855723|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855724|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855725|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855726|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855727|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855728|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855729|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855730|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855731|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855732|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855733|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855734|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855735|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855978|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855736|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855737|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855738|NCT01216072|O3|Outcome|Extension Fingolimod Period|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855739|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
855740|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855741|NCT01216072|O2|Outcome|Multiple Sclerosis Disease Modifying Treatments (MS DMTs)|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855742|NCT01216072|O1|Outcome|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855743|NCT01216072|E3|Reported Event|Fingolimod Extension Phase|An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
855744|NCT01216072|E2|Reported Event|Standard MS DMT|Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months.
855745|NCT01216072|E1|Reported Event|Fingolimod|Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period.
855746|NCT01215981|B3|Baseline|Total|Total of all reporting groups
855747|NCT01215981|B2|Baseline|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
855748|NCT01215981|B1|Baseline|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
855749|NCT01215981|P2|Participant Flow|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
855750|NCT01215981|P1|Participant Flow|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
855751|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
855752|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
855753|NCT01215981|O2|Outcome|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 2 doses (day of enrollment and 4 weeks after later) of seasonal influenza vaccine after transplant.
855754|NCT01215981|O1|Outcome|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|Allogeneic hematopoietic stem cell transplant (HSCT) recipients who received 1 dose (day of enrollment) of seasonal influenza vaccine after transplant.
855755|NCT01215981|E2|Reported Event|HSCT Recipients Who Were Randomized to 2 Vaccine Doses|
855756|NCT01215981|E1|Reported Event|HSCT Recipients Who Were Randomized to 1 Vaccine Dose|
855757|NCT01215968|B3|Baseline|Total|Total of all reporting groups
855758|NCT01215968|B2|Baseline|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855759|NCT01215968|B1|Baseline|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855760|NCT01215968|P2|Participant Flow|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855761|NCT01215968|P1|Participant Flow|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855762|NCT01215968|O3|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
855763|NCT01215968|O2|Outcome|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855764|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855765|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855766|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855767|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855768|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855769|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855770|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855771|NCT01215968|O2|Outcome|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855772|NCT01215968|O1|Outcome|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855773|NCT01215968|E3|Reported Event|LY2189265|Participants received placebo on Week 1 and once-weekly doses of 1.5 mg LY2189265 on Weeks 2 to 5.
855774|NCT01215968|E2|Reported Event|Placebo (Week 1)|Participants received placebo on Week 1 and went on to receive once-weekly doses of 1.5 milligram (mg) LY2189265 on Weeks 2 to 5.
855775|NCT01215968|E1|Reported Event|Placebo|Participants received placebo on Week 1 and once-weekly doses of placebo on Weeks 2 to 5.
855776|NCT01215955|B5|Baseline|Total|Total of all reporting groups
855871|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
855777|NCT01215955|B4|Baseline|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855778|NCT01215955|B3|Baseline|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855779|NCT01215955|B2|Baseline|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based dose was on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855780|NCT01215955|B1|Baseline|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855781|NCT01215955|P4|Participant Flow|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855782|NCT01215955|P3|Participant Flow|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855783|NCT01215955|P2|Participant Flow|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855784|NCT01215955|P1|Participant Flow|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855785|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855786|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855787|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855788|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855789|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855790|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855791|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855979|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855792|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855793|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855794|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855795|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855796|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855938|NCT01215721|P1|Participant Flow|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
855797|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855798|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855799|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855800|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855801|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855802|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855803|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855804|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855805|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855806|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855807|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855808|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855809|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855810|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855811|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855939|NCT01215721|O1|Outcome|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
855812|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855813|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855814|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855815|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855816|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855817|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855818|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855819|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855820|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855821|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855822|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855823|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855824|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855825|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855826|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855940|NCT01215721|E1|Reported Event|Vesicare, 5mg Treatment Group|Vesicare™ (Solifenacin) : 5 mg daily
855827|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855828|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855829|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855830|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855831|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855832|NCT01215955|O1|Outcome|Study A Q1D|"Insulin Lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855833|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855834|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855835|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855836|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855837|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855838|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855839|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855840|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855841|NCT01215955|O4|Outcome|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855941|NCT01215643|B6|Baseline|Total|Total of all reporting groups
855842|NCT01215955|O3|Outcome|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855843|NCT01215955|O2|Outcome|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855844|NCT01215955|O1|Outcome|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated dose was based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855845|NCT01215955|E4|Reported Event|Study B Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855846|NCT01215955|E3|Reported Event|Study B Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study B according to an allocation plan that was pre-specified before initiation of Study B."
855847|NCT01215955|E2|Reported Event|Study A Q3D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose readings from the past 3 days (Q3D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q3D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855848|NCT01215955|E1|Reported Event|Study A Q1D|"Insulin lispro administered subcutaneously, up to 3 times daily for 24 weeks. Mealtime bolus of insulin lispro self-titrated based on blood glucose reading from the previous day (Q1D).~Glargine participant-dependent doses, administered subcutaneously once daily for 24 weeks.~Participants were randomized to Q1D at the site level: sites were assigned to Study A according to an allocation plan that was pre-specified before initiation of Study A."
855849|NCT01215929|B3|Baseline|Total|Total of all reporting groups
855850|NCT01215929|B2|Baseline|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
855851|NCT01215929|B1|Baseline|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
855872|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
878855|NCT01151436|O1|Outcome|Hyaluronic Acid|
855852|NCT01215929|P2|Participant Flow|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
855853|NCT01215929|P1|Participant Flow|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
855854|NCT01215929|O2|Outcome|Placebo|Placebo: Thirty-five treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
855855|NCT01215929|O1|Outcome|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
855856|NCT01215929|E2|Reported Event|Placebo|Placebo: Thirty-four treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 17 Participants were randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 weeks.
855857|NCT01215929|E1|Reported Event|Dextroamphetamine|Dextroamphetamine: Thirty-five treatment-seeking methamphetamine dependent volunteers were admitted to a residential facility and inducted onto d-amphetamine during week 1 of the study. 18 Participants were be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
855859|NCT01215851|B6|Baseline|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
855860|NCT01215851|B5|Baseline|Rifafour e-275 mg|Rifafour e-275 administered once daily with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
855861|NCT01215851|B4|Baseline|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets and pyrazinamide administered once daily in 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
855862|NCT01215851|B3|Baseline|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
855863|NCT01215851|B2|Baseline|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855864|NCT01215851|B1|Baseline|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855865|NCT01215851|P6|Participant Flow|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
855866|NCT01215851|P5|Participant Flow|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
855867|NCT01215851|P4|Participant Flow|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
855868|NCT01215851|P3|Participant Flow|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
855869|NCT01215851|P2|Participant Flow|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855870|NCT01215851|P1|Participant Flow|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855873|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
855874|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
855875|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855876|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855877|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
855878|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
855942|NCT01215643|B5|Baseline|PEG+RBV|PEG and RBV during Weeks 1 to 24.
857833|NCT01211145|E3|Reported Event|ZOMIG 2.5 mg|ZOMIG nasal spray
855879|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
855880|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
855881|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855882|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855883|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
855884|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
855885|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
855886|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
855887|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|MC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855888|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855889|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
855890|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
855891|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
855977|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856142|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
855892|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
855893|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855894|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855895|NCT01215851|O6|Outcome|TMC207 and PA-824|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14
855896|NCT01215851|O5|Outcome|Rifafour e-275 mg|Rifafour e-275 administered once daily on Days 1-14 with each tablet containing 150mg rifampicin, 75mg isoniazid, 400mg pyrazinamide, and 275mg ethambutol and dosed by weight as follows: 30kg - 37kg received 2 tablets/day; 38kg - 54kg received 3 tablets/day; 55kg - 70kg received 4 tablets/day; > or = 71kg received 5 tablets/day
855897|NCT01215851|O4|Outcome|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin administered once daily as 400mg tablets for a total daily dose of 400mg on Days 1-14
855898|NCT01215851|O3|Outcome|PA-824 and Pyrazinamide|PA-824 administered once daily as 200mg tablets for a total daily dose of 200mg on Days 1-14, pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day, and moxifloxacin placebo tablets (matched to moxifloxacin tablets) administered once daily on Days 1-14
855899|NCT01215851|O2|Outcome|TMC207 and Pyrazinamide|TMC207 administered once daily as 100mg tablet for total daily dose of 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide administered once daily on Days 1-14 as 500mg tablets dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855900|NCT01215851|O1|Outcome|TMC207|TMC207 administered once daily as 100mg tablets for a total daily dose of 700mg on Day 1; 500mg on Day 2; 400mg on Days 3-14 plus pyrazinamide placebo tablets (matched to pyrazinamide tablets) administered once daily on Days 1-14 dosed by weight as follows: < or = 55kg 2 tablets/day; >55kg to 75kg 3 tablets/day; >75kg 4 tablets/day
855901|NCT01215851|E6|Reported Event|TMC207 and PA-824|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus PA-824 200 mg
855902|NCT01215851|E5|Reported Event|Rifafour e-275 mg|Rifafour e-275 275 mg
855903|NCT01215851|E4|Reported Event|PA-824 and Moxifloxacin and Pyrazinamide|PA-824 200 mg and pyrazinamide (dosed by weight) and moxifloxacin 400 mg
855904|NCT01215851|E3|Reported Event|PA-824 and Pyrazinamide|PA-824 200mg and pyrazinamide (dosed by weight)and moxifloxacin placebo
855905|NCT01215851|E2|Reported Event|TMC207 and Pyrazinamide|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide (dosed by weight)
855906|NCT01215851|E1|Reported Event|TMC207|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14 plus pyrazinamide placebo
855907|NCT01215786|B4|Baseline|Total|Total of all reporting groups
855908|NCT01215786|B3|Baseline|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
855909|NCT01215786|B2|Baseline|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
855910|NCT01215786|B1|Baseline|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
855911|NCT01215786|P3|Participant Flow|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
855912|NCT01215786|P2|Participant Flow|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
855913|NCT01215786|P1|Participant Flow|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
855914|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
855915|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
855916|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
855917|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
855918|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
855919|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
855920|NCT01215786|O3|Outcome|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
855921|NCT01215786|O2|Outcome|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
855922|NCT01215786|O1|Outcome|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
855923|NCT01215786|E3|Reported Event|Placebo|AGN-207281 vehicle ophthalmic solution (Placebo)
855924|NCT01215786|E2|Reported Event|Timolol Ophthalmic Solution 0.5%|timolol ophthalmic solution 0.5%
855925|NCT01215786|E1|Reported Event|AGN-207281 Ophthalmic Solution|AGN-207281 0.1% ophthalmic solution on Days 1-7 and AGN-207281 0.3% ophthalmic solution on Days 8-14
855926|NCT01215734|B3|Baseline|Total|Total of all reporting groups
855927|NCT01215734|B2|Baseline|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
855928|NCT01215734|B1|Baseline|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
855929|NCT01215734|P2|Participant Flow|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post-transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
855930|NCT01215734|P1|Participant Flow|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
855931|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
855932|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
855933|NCT01215734|O2|Outcome|Standard Dose Trivalent Inactivated Flu Vaccine|Standard Dose TIV : Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant will receive SD (15 µg/per antigen) TIV on visit 1.
855934|NCT01215734|O1|Outcome|High-Dose Trivalent Inactivated Influenza Vaccine|High Dose: Adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive HD TIV (60 micrograms [µg] per antigen) on visit 1
855935|NCT01215734|E2|Reported Event|Standard Dose Trivalent Inactivated Flu Vaccine|"Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.~Standard Dose Trivalent Inactivated Flu Vaccine : Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1."
855936|NCT01215734|E1|Reported Event|High-Dose Trivalent Inactivated Influenza Vaccine|"Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine~High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) : 0.5 ml of HD-TIV on visit 1"
855937|NCT01215721|B1|Baseline|Vesicare|Vesicare™ (Solifenacin) : 5 mg daily
855997|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855943|NCT01215643|B4|Baseline|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855944|NCT01215643|B3|Baseline|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855945|NCT01215643|B2|Baseline|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855946|NCT01215643|B1|Baseline|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855947|NCT01215643|P5|Participant Flow|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855948|NCT01215643|P4|Participant Flow|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with peginterferon alfa-2a (PEG) during Weeks 2 to 24.
855949|NCT01215643|P3|Participant Flow|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855950|NCT01215643|P2|Participant Flow|ALV 600 mg+RBV|ALV 600 mg BID with ribavirin (RBV) for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855951|NCT01215643|P1|Participant Flow|ALV 1000 mg|Alisporivir (ALV) 600 mg twice daily (BID) for 1 week, followed by ALV 1000 mg once daily (QD) during Weeks 2 to 24.
855952|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855953|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855954|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855955|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855956|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855957|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855958|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855959|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855960|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855961|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855962|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855963|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855964|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855965|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855966|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855967|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855968|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855969|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855970|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855971|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855972|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855973|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855974|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855975|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855976|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855980|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855981|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855982|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855983|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855984|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855985|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855986|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855987|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855988|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855989|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855990|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855991|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855992|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
855993|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855994|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
855995|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
855996|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
855998|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
855999|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856000|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856001|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856002|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856003|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856004|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856005|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856006|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856007|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856008|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856009|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856010|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856011|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856012|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856013|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856014|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856015|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856016|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856017|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856018|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856019|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856020|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856021|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856022|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856023|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856024|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856025|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856026|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856027|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856028|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856029|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856030|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856031|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856032|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856033|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856034|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
878856|NCT01151436|O1|Outcome|Hyaluronic Acid|
856035|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856036|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856037|NCT01215643|O5|Outcome|PEG+RBV|PEG and RBV during Weeks 1 to 24.
856038|NCT01215643|O4|Outcome|ALV 600 mg+PEG|ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856039|NCT01215643|O3|Outcome|ALV 800 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856040|NCT01215643|O2|Outcome|ALV 600 mg+RBV|ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856041|NCT01215643|O1|Outcome|ALV 1000 mg|ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856042|NCT01215643|E10|Reported Event|PEG+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving PEG and RBV during Weeks 1 to 24.
856043|NCT01215643|E9|Reported Event|ALV 600 mg+PEG: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856044|NCT01215643|E8|Reported Event|ALV 800 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856045|NCT01215643|E7|Reported Event|ALV 600 mg+RBV: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856046|NCT01215643|E6|Reported Event|ALV 1000 mg: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856047|NCT01215643|E5|Reported Event|PEG+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving PEG and RBV during Weeks 1 to 24.
856072|NCT01215422|B5|Baseline|Total|Total of all reporting groups
857834|NCT01211145|E2|Reported Event|ZOMIG 0.5 mg|ZOMIG nasal spray
856048|NCT01215643|E4|Reported Event|ALV 600 mg+PEG: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with PEG for 1 week, followed by ALV 600 mg QD with PEG during Weeks 2 to 24.
856049|NCT01215643|E3|Reported Event|ALV 800 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 800 mg QD with RBV during Weeks 2 to 24.
856050|NCT01215643|E2|Reported Event|ALV 600 mg+RBV: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 600 mg BID with RBV for 1 week, followed by ALV 600 mg QD with RBV during Weeks 2 to 24.
856051|NCT01215643|E1|Reported Event|ALV 1000 mg: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg BID for 1 week, followed by ALV 1000 mg QD during Weeks 2 to 24.
856052|NCT01215513|B1|Baseline|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
856053|NCT01215513|P1|Participant Flow|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
856054|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals
856055|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
856056|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
856057|NCT01215513|O1|Outcome|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
856058|NCT01215513|E1|Reported Event|Degarelix|80 mg degarelix at a concentration of 20 mg/mL were administered as a single 4 mL subcutaneous injection at monthly intervals.
856059|NCT01215435|B3|Baseline|Total|Total of all reporting groups
856060|NCT01215435|B2|Baseline|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856061|NCT01215435|B1|Baseline|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856062|NCT01215435|P2|Participant Flow|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856063|NCT01215435|P1|Participant Flow|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856064|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856065|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856139|NCT01215279|P2|Participant Flow|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856066|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856067|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856068|NCT01215435|O2|Outcome|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856069|NCT01215435|O1|Outcome|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856070|NCT01215435|E2|Reported Event|Pre-dinner BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-dinner. Then they were intensified to BID or TID if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856071|NCT01215435|E1|Reported Event|Pre-breakfast BIAsp 30|Subjects were started on BIAsp 30 (a biphasic formulation of insulin aspart (IAsp) in which 30% is soluble and the remaining 70% is protaminized insulin aspart) subcutaneously once daily (OD) pre-breakfast. Then they were intensified to twice daily (BID) or thrice daily (TID) if glycaemic control is not achieved, within three 12 weeks of treatment phases by titrating according to SMBG levels.
856073|NCT01215422|B4|Baseline|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
856074|NCT01215422|B3|Baseline|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
856075|NCT01215422|B2|Baseline|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
856076|NCT01215422|B1|Baseline|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
856077|NCT01215422|P4|Participant Flow|GS Intubation Participants|Children intubated with the GlideScope system (GS) VLS
856078|NCT01215422|P3|Participant Flow|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface DCI (KS) VLS
856079|NCT01215422|P2|Participant Flow|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice.
856080|NCT01215422|P1|Participant Flow|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
856081|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who intubated minimum 18 children with the KS VLS
856082|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who intubated minimum 18 children with the GS VLS.
856083|NCT01215422|O2|Outcome|Randomized to KS First|
856084|NCT01215422|O1|Outcome|Randomized to GS First|
856085|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated with the standard laryngoscope of the anesthesiologist's choice
856086|NCT01215422|O2|Outcome|KS Intubation Participants|Children successfully intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
856087|NCT01215422|O1|Outcome|GS Intubation Participants|Children successfully intubated with the GlideScope system (GS) video laryngoscope (VLS)
856088|NCT01215422|O4|Outcome|KS Intubation Times for Those Who Used GS First|
856089|NCT01215422|O3|Outcome|GS Intubation Times for Those Who Used KS First|
856090|NCT01215422|O2|Outcome|KS Intubation Times for Those Who Used KS First|
856091|NCT01215422|O1|Outcome|GS Intubation Times for Those Who Used GS First|
856092|NCT01215422|O3|Outcome|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope of the anesthesiologist's choice
856093|NCT01215422|O2|Outcome|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
856094|NCT01215422|O1|Outcome|GS Intubation Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
856095|NCT01215422|O2|Outcome|KS Intubations|Anesthesiologists who performed minimum 18 intubations with the KS VLS
856096|NCT01215422|O1|Outcome|GS Intubations|Anesthesiologists who performed minimum 18 intubations with the GS VLS.
856097|NCT01215422|E4|Reported Event|GS Intubaton Participants|Children intubated with the GlideScope system (GS) video laryngoscope (VLS)
856098|NCT01215422|E3|Reported Event|KS Intubation Participants|Children intubated with the Karl Storz Direct Coupled Interface (DCI) (KS) video laryngoscope (VLS)
856099|NCT01215422|E2|Reported Event|Baseline Intubation Participants|Children intubated at baseline using the standard laryngoscope blade of the anesthesiologist's choice
856140|NCT01215279|P1|Participant Flow|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856141|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856100|NCT01215422|E1|Reported Event|Overall Anesthesiologists|Baseline intubation times were obtained on a convenience sample of 20 children using the standard laryngoscope blade of their choice. Then anesthesiologists were randomized to complete either 20 intubations with the GlideScope system (GS) video laryngoscope (VLS) or 20 with the Karl Storz Direct Coupled Interface DCI (KS) VLS first. Once they had intubated 20 children with the VLS to which they were randomized, they crossed over to use the alternate VLS for 20 intubations.
856101|NCT01215357|B1|Baseline|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
856102|NCT01215357|P1|Participant Flow|Ecopipam (50 or 100 mg, as Needed)|Patients were instructed to take a 50 mg tablet each time they had an urge to gamble. If that was ineffective, they were instructed to take a second 50 mg tablet. If that was ineffective, they were not allowed to increase the dose further.
856103|NCT01215357|O1|Outcome|Ecopipam 50 mg or 100 mg as Needed|Patients were instructed to take one 50 mg tablet of ecopipam when they had an urge to gamble. If this was effective, they should not take any more drug. If it was not effective, they were permitted to take a second 50 mg tablet of ecopipam. If this was effective, they should not take any more drug. If this was not effective, they were not permitted to take any additional ecopipam.
856104|NCT01215357|E1|Reported Event|Ecopipam 50 or 100 mg, as Needed|Patients were instructed to take a 50 mg tablet of ecopipam when they had an urge to gamble. If no effect, then they could take a second 50 mg tablet. If still no effect, they were not permitted to take any more ecopipam.
856105|NCT01215292|B6|Baseline|Total|Total of all reporting groups
856106|NCT01215292|B5|Baseline|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
856107|NCT01215292|B4|Baseline|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
856108|NCT01215292|B3|Baseline|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
856109|NCT01215292|B2|Baseline|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
856163|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856110|NCT01215292|B1|Baseline|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
856111|NCT01215292|P5|Participant Flow|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
856112|NCT01215292|P4|Participant Flow|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
856113|NCT01215292|P3|Participant Flow|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
856114|NCT01215292|P2|Participant Flow|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
856115|NCT01215292|P1|Participant Flow|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
856116|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
856117|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
856118|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
856119|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|Acyline injection 300 mcg/kg SC (day 1) + Testosterone gel 5g + ketoconazole
856120|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|
856121|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + Anastrazole 1mg x 7 days
856122|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + dutasteride 2.5mg x 7 days
856123|NCT01215292|O3|Outcome|Acyline & TGel & Ketoconazole 800 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + 800mg ketoconazole x 7 days
856124|NCT01215292|O2|Outcome|Acyline & TGel & Ketoconazole 400 mg|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + ketoconazole 400mg x 7 days
856125|NCT01215292|O1|Outcome|Acyline + Testosterone Gel (Tgel)+ Placebo|Acyline 300mcg/kg Subcutaneous (SC) (day 1) + testosterone Gel 5g daily x10 days + placebo
856126|NCT01215292|O5|Outcome|Acyline & TGel & Anastrazole 1mg|
856127|NCT01215292|O4|Outcome|Acyline & TGel & Dutasteride 2.5mg|
856128|NCT01215292|O3|Outcome|Acyline + Tgel + Ketoconazole 800mg|300mcg Acyline, 1% testosterone gel 5g daily + 800 mg ketoconazole
856129|NCT01215292|O2|Outcome|Acyline + Tgel + Ketoconazole 400mg|300mcg Acyline, 1% testosterone gel 5g daily + 400 mg ketoconazole
856130|NCT01215292|O1|Outcome|Acyline + Testosterone Gel + Placebo|300mcg Acyline, 1% testosterone gel 5g daily + placebo
856131|NCT01215292|E5|Reported Event|Group 5: Anastrazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + anastrazole 1 mg PO 1x daily, Days 3-10
856132|NCT01215292|E4|Reported Event|Acyline & T Gel & Ketoconazole 800|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + ketoconazole 800mg PO 1x daily, Days 3-10
856133|NCT01215292|E3|Reported Event|Acyline & T Gel & Placebo Ketoconazole|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel (T gel) 5 gm daily Days 1-10, + placebo tab PO 1x daily, Day 3-10
856134|NCT01215292|E2|Reported Event|Acyline & T Gel & Dutasteride|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Day 1-10, + dutasteride 2.5 mg PO 1x daily, Days 3-10
856135|NCT01215292|E1|Reported Event|Acyline & T Gel & Ketoconazole 400|Acyline 300 mcg/kg on Day 1 + 1% testosterone gel 5 gm daily Days 1-10, + ketoconazole 400mg PO 1x daily, Days 3-10
856136|NCT01215279|B3|Baseline|Total|Total of all reporting groups
856137|NCT01215279|B2|Baseline|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856138|NCT01215279|B1|Baseline|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856143|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856144|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856145|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856146|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856147|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856148|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856149|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856150|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856151|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856152|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856153|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856154|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856155|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856156|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856157|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856158|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856159|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856160|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856161|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856162|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
857835|NCT01211145|E1|Reported Event|Placebo|Placebo to ZOMIG nasal spray
856164|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856165|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856166|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856167|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856168|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856169|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856170|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856171|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856172|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856173|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856174|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856175|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856176|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856177|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856178|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856179|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856180|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856181|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856182|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856183|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856184|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856185|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856186|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856187|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856188|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856189|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856190|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856191|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856192|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856193|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856194|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856195|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856196|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856197|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856198|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856199|NCT01215279|O2|Outcome|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856200|NCT01215279|O1|Outcome|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856201|NCT01215279|E2|Reported Event|Placebo|Placebo to match AZD2423 50 mg tablets, once daily for 28 days
856202|NCT01215279|E1|Reported Event|AZD2423 100 mg|Two 50 mg AZD2423 tablets, once daily for 28 days
856203|NCT01215227|B7|Baseline|Total|Total of all reporting groups
856261|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
856204|NCT01215227|B6|Baseline|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856205|NCT01215227|B5|Baseline|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856206|NCT01215227|B4|Baseline|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856207|NCT01215227|B3|Baseline|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856208|NCT01215227|B2|Baseline|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856209|NCT01215227|B1|Baseline|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856210|NCT01215227|P6|Participant Flow|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
857836|NCT01211106|B3|Baseline|Total|Total of all reporting groups
856211|NCT01215227|P5|Participant Flow|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856212|NCT01215227|P4|Participant Flow|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856213|NCT01215227|P3|Participant Flow|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856214|NCT01215227|P2|Participant Flow|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856215|NCT01215227|P1|Participant Flow|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856216|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856217|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856218|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856219|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856220|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856221|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856222|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
878857|NCT01151436|O1|Outcome|Hyaluronic Acid|
856223|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856224|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856225|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856226|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856227|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856228|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856229|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856283|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
856284|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
856230|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856231|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856232|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856233|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856234|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856235|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856236|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856237|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856238|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856239|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856240|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856241|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856242|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856243|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856244|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856245|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856246|NCT01215227|O6|Outcome|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856247|NCT01215227|O5|Outcome|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856248|NCT01215227|O4|Outcome|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856285|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
856286|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856249|NCT01215227|O3|Outcome|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856250|NCT01215227|O2|Outcome|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856251|NCT01215227|O1|Outcome|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856252|NCT01215227|E6|Reported Event|Rasagiline 1 mg (on Placebo in Parent Study)|Participants who received placebo to rasagiline capsule in parent study NCT01155466 or NCT01227265 received rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856253|NCT01215227|E5|Reported Event|Rasagiline 1 mg|Participants who received rasagiline 1 mg in parent study NCT01155466 or NCT01227265 continued to receive rasagiline 1 mg in this extension study. Participants received rasagiline 1 mg capsule once a day: one capsule plus placebo tablet to preladenant in the morning, and one placebo tablet to preladenant in the evening, for 40 weeks.
856254|NCT01215227|E4|Reported Event|Preladenant 10 mg|Participants who received preladenant 10 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 10 mg in this extension study. Participants received preladenant 10 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856255|NCT01215227|E3|Reported Event|Preladenant 5 mg (on Placebo in Parent Study)|Participants who received placebo to preladenant tablet in parent study NCT01155466 or NCT01227265 received preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856256|NCT01215227|E2|Reported Event|Preladenant 5 mg|Participant who received preladenant 5 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 5 mg in this extension study. Participants received preladenant 5 mg taken orally BID: one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856257|NCT01215227|E1|Reported Event|Preladenant 2 mg|Participants who received preladenant 2 mg in parent study NCT01155466 or NCT01227265 continued to receive preladenant 2 mg in this extension study. Participants received preladenant 2 mg taken orally twice daily (BID): one tablet plus placebo capsule to rasagiline in the morning, and one tablet in the evening, for 40 weeks.
856258|NCT01215123|B1|Baseline|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
856259|NCT01215123|P1|Participant Flow|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
856260|NCT01215123|O1|Outcome|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
856618|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856262|NCT01215123|E1|Reported Event|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed. Treatment continued for a maximum of 22 cycles.
856263|NCT01215110|B6|Baseline|Total|Total of all reporting groups
856264|NCT01215110|B5|Baseline|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856265|NCT01215110|B4|Baseline|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856266|NCT01215110|B3|Baseline|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856267|NCT01215110|B2|Baseline|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856268|NCT01215110|B1|Baseline|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856269|NCT01215110|P5|Participant Flow|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856270|NCT01215110|P4|Participant Flow|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
856271|NCT01215110|P3|Participant Flow|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
856272|NCT01215110|P2|Participant Flow|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
856273|NCT01215110|P1|Participant Flow|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
856274|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
856275|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
856276|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
856277|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
856278|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
856279|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14
856280|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14.
856281|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1; and 100 mg Days 2-14
856282|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; and 400 mg Days 3-14
856287|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856288|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856289|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856290|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856291|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856292|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856293|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856294|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856295|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856296|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856297|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856298|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856299|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856300|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856301|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856302|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856303|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856304|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856305|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856306|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856307|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856308|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856309|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856310|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856311|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856312|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856313|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856314|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856315|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856316|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856317|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856318|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856319|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856320|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856321|NCT01215110|O5|Outcome|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856322|NCT01215110|O4|Outcome|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856323|NCT01215110|O3|Outcome|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856324|NCT01215110|O2|Outcome|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856325|NCT01215110|O1|Outcome|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856326|NCT01215110|E5|Reported Event|Rifafour e-275 mg|Daily Doses: 30 to 37 kg, 2 tablets; 38 to 54 kg, 3 tablets; 55 to 70 kg, 4 tablets; 71 kg and over, 5 tablets
856327|NCT01215110|E4|Reported Event|TMC207 400|TMC207- 700 mg Day 1; 500 mg Day 2; 400 mg Days 3-14
856328|NCT01215110|E3|Reported Event|TMC207 300|TMC207- 500 mg Day 1; 400 mg Day 2 and 300 mg Days 3-14.
856329|NCT01215110|E2|Reported Event|TMC207 200|TMC207- 400 mg Day 1; 300 mg Day 2 and 200 mg Days 3-14
856330|NCT01215110|E1|Reported Event|TMC207 100|TMC207- 200 mg Day 1 and 100 mg Days 2-14
856331|NCT01215097|B3|Baseline|Total|Total of all reporting groups
856332|NCT01215097|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856333|NCT01215097|B1|Baseline|Placebo|Placebo
856334|NCT01215097|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856335|NCT01215097|P1|Participant Flow|Placebo|Placebo
856336|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856337|NCT01215097|O1|Outcome|Placebo|Placebo
856338|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856339|NCT01215097|O1|Outcome|Placebo|Placebo
856340|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856341|NCT01215097|O1|Outcome|Placebo|Placebo
856342|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856343|NCT01215097|O1|Outcome|Placebo|Placebo
856344|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856345|NCT01215097|O1|Outcome|Placebo|Placebo
856346|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856347|NCT01215097|O1|Outcome|Placebo|Placebo
856348|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856349|NCT01215097|O1|Outcome|Placebo|Placebo
856350|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856351|NCT01215097|O1|Outcome|Placebo|Placebo
856352|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856353|NCT01215097|O1|Outcome|Placebo|Placebo
856354|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856355|NCT01215097|O1|Outcome|Placebo|Placebo
856356|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856357|NCT01215097|O1|Outcome|Placebo|Placebo
856358|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856359|NCT01215097|O1|Outcome|Placebo|Placebo
856360|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856361|NCT01215097|O1|Outcome|Placebo|Placebo
856362|NCT01215097|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856363|NCT01215097|O1|Outcome|Placebo|Placebo
856364|NCT01215097|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856365|NCT01215097|E1|Reported Event|Placebo|Placebo
856366|NCT01215032|B1|Baseline|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
856367|NCT01215032|P1|Participant Flow|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
856368|NCT01215032|O2|Outcome|Abnormal Baseline Hemoglobin A1c|Hemoglobin A1c greater than or equal to 6.0 before metformin dosing began.
856369|NCT01215032|O1|Outcome|Normal Baseline Hemoglobin A1c|Hemoglobin A1c less than 6.0 before metformin dosing began.
856370|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
856371|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
856372|NCT01215032|O1|Outcome|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle, for 12 cycles"
856373|NCT01215032|E1|Reported Event|Metformin|"This is the only arm of this phase 2 open label study~Metformin: Taken orally twice daily each 28-day cycle"
856374|NCT01214980|B3|Baseline|Total|Total of all reporting groups
856375|NCT01214980|B2|Baseline|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856376|NCT01214980|B1|Baseline|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856377|NCT01214980|P2|Participant Flow|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856378|NCT01214980|P1|Participant Flow|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856379|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856410|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856411|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
878858|NCT01151436|O1|Outcome|Hyaluronic Acid|
856380|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856381|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856382|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856383|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856384|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856385|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856386|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856429|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856387|NCT01214980|O2|Outcome|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856388|NCT01214980|O1|Outcome|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856389|NCT01214980|E2|Reported Event|Control Arm|"Standard of care treatment~Standard of care: Standard of care provided per site-specific protocol Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma"
856390|NCT01214980|E1|Reported Event|MIST Therapy in Conjunction With Standard Care|"Low-frequency, non-contact ultrasound administered in conjunction with standard of care treatment~MIST Therapy: Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment (Wound cleansing followed by application of a hydrocolloid border and a transparent dressing for a moist wound environment that allows for dressing removal without trauma) on a daily basis for 5 days."
856391|NCT01214915|B1|Baseline|Anagrelide Hydrochloride|
856392|NCT01214915|P1|Participant Flow|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
856393|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
856394|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
856395|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
856396|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
856397|NCT01214915|O1|Outcome|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day orally and titrated as necessary.
856398|NCT01214915|E1|Reported Event|Anagrelide Hydrochloride|
856399|NCT01214850|B4|Baseline|Total|Total of all reporting groups
856400|NCT01214850|B3|Baseline|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856401|NCT01214850|B2|Baseline|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856402|NCT01214850|B1|Baseline|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856403|NCT01214850|P3|Participant Flow|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856404|NCT01214850|P2|Participant Flow|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856405|NCT01214850|P1|Participant Flow|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856406|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856407|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856408|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856409|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
856412|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856413|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856414|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856415|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856416|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856417|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856418|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856419|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856420|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856421|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856422|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856423|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856424|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856425|NCT01214850|O3|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856426|NCT01214850|O2|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856427|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856428|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856430|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856431|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856432|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856433|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856434|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856435|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856436|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856437|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856438|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856439|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856440|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856441|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856442|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856443|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856444|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856445|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856446|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856447|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856448|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856449|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856450|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856451|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856452|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856453|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856454|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856455|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856456|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856457|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856458|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856459|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856460|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856461|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856462|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856463|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856464|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856465|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856466|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart.
856467|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856468|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856469|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856470|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856471|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856472|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856473|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856474|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856475|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856476|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856477|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856478|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856479|NCT01214850|O1|Outcome|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856480|NCT01214850|O2|Outcome|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856481|NCT01214850|O1|Outcome|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856482|NCT01214850|E3|Reported Event|Control|Subjects (18-24 years) received two injections of a control vaccine (Japanese Encephalitis), one month apart
856483|NCT01214850|E2|Reported Event|MenACWY|Subjects (18-24 years) received one injection of MenACWY-CRM vaccine followed by one injection of placebo, one month apart
856484|NCT01214850|E1|Reported Event|rMenB+OMV|Subjects (18-24 years) received two injections of rMenB+OMV NZ vaccine, one month apart
856485|NCT01214837|B4|Baseline|Total|Total of all reporting groups
856486|NCT01214837|B3|Baseline|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856487|NCT01214837|B2|Baseline|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856488|NCT01214837|B1|Baseline|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856489|NCT01214837|P3|Participant Flow|Routine Vaccines|Subjects received routine vaccines only, including pneumococcal 13-valent conjugate vaccine (PCV-13), at 2, 4, 6 and 12 months of age.
856490|NCT01214837|P2|Participant Flow|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856491|NCT01214837|P1|Participant Flow|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856492|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856493|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856494|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856495|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856496|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856497|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856498|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856499|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856500|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856501|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856502|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856619|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
856503|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856504|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856505|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856506|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856507|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856508|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856509|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856510|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856511|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856512|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856513|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856514|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856515|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856579|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856516|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856517|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856518|NCT01214837|O3|Outcome|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856519|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856520|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856521|NCT01214837|O2|Outcome|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856522|NCT01214837|O1|Outcome|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856523|NCT01214837|O1|Outcome|MenACWY4|All subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856524|NCT01214837|E3|Reported Event|Routine Vaccines|Subjects received routine vaccines only, including PCV-13, at 2, 4, 6 and 12 months of age.
856525|NCT01214837|E2|Reported Event|MenACWY4|Subjects received a 3-dose primary series at 2, 4 and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
856526|NCT01214837|E1|Reported Event|MenACWY3|Subjects received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
856527|NCT01214824|B1|Baseline|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
856528|NCT01214824|P1|Participant Flow|Intervention Group|Participants using the FreeStyle Navigator System Intermittently. At the start and end of the study subjects wore the FreeStyle Navigator masked (without seeing continuous glucose results) for 5 days (1 sensor wear). During the study subjects used the FreeStyle Navigator fully functional (unmasked) for 2 periods. The first unmasked phase was for 2 weeks (3 sensor wears) following the baseline masked wear. The second unmasked phase was a 5 day wear at 3 months. After each unmasked phase the HCP reviewed results with the subject and changes to insulin regimen were recommended as required. For the remainder of the study a standard blood glucose meter was used for diabetes management.
856529|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
856530|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
856531|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System intermittently
856532|NCT01214824|O1|Outcome|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
856533|NCT01214824|E1|Reported Event|Intervention Group|Participants using the FreeStyle Navigator System Intermittently
856534|NCT01214811|B1|Baseline|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
856535|NCT01214811|P1|Participant Flow|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
856536|NCT01214811|O1|Outcome|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
856620|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856537|NCT01214811|E1|Reported Event|Mepilex Border Ag|"Non comparative study with one active arm - Mepilex Border Ag~Mepilex Border Ag : Mepilex Border Ag may be left in place for up to seven days, depending on the condition."
856538|NCT01214759|B1|Baseline|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
856539|NCT01214759|P1|Participant Flow|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
856540|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
856541|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
856542|NCT01214759|O1|Outcome|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
856543|NCT01214759|E1|Reported Event|Truvada and Raltegravir|"Single arm~Truvada: Tenofovir 200mg/emtricitabine 300mg once a day~Raltegravir: Raltegravir 400mg twice a day"
856544|NCT01214720|B3|Baseline|Total|Total of all reporting groups
856545|NCT01214720|B2|Baseline|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856546|NCT01214720|B1|Baseline|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856580|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856547|NCT01214720|P2|Participant Flow|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856548|NCT01214720|P1|Participant Flow|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg per square meter (mg/m^2) IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, orally (PO), once daily (QD) for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856549|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856550|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856551|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856552|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856565|NCT01214616|B4|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
856566|NCT01214616|B3|Baseline|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
856553|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856554|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856555|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856556|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856557|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856757|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856558|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856559|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856560|NCT01214720|O2|Outcome|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856561|NCT01214720|O1|Outcome|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856562|NCT01214720|E2|Reported Event|Placebo + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received placebo IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received placebo IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856563|NCT01214720|E1|Reported Event|Bevacizumab + Gemcitabine + Erlotinib|"Cycle 1 (8-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1, 15, 29, and 43 (followed by 1 week off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 (followed by 1 week off); and erlotinib 100 mg tablets/capsules, PO, QD for 8 weeks.~Cycles 2 and beyond (4-week cycle): Participants received bevacizumab 5 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); gemcitabine 1000 mg/m^2 IV on Days 1, 8, and 15 (followed by 1 week off); and erlotinib 100 mg tablets/capsules PO QD. Participants continued on treatment until disease progression, unacceptable toxicity, or participant withdrawal."
856564|NCT01214616|B5|Baseline|Total|Total of all reporting groups
856567|NCT01214616|B2|Baseline|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856568|NCT01214616|B1|Baseline|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856569|NCT01214616|P4|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
856570|NCT01214616|P3|Participant Flow|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
856571|NCT01214616|P2|Participant Flow|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856572|NCT01214616|P1|Participant Flow|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856573|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
856574|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
856575|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856576|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856577|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
856578|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
859762|NCT01203072|B5|Baseline|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
856581|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856582|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856583|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856584|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856585|NCT01214616|O4|Outcome|Vinorelbine 25 mg/m^2 Without Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856586|NCT01214616|O3|Outcome|Vinorelbine 25 mg/m^2 With Afatinib|"Vinorelbine 25 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856587|NCT01214616|O2|Outcome|Vinorelbine 20 mg/m^2 Without Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly without afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856588|NCT01214616|O1|Outcome|Vinorelbine 20 mg/m^2 With Afatinib|"Vinorelbine 20 mg/m^2 intravenous injection weekly with afatinib oral administration once a day.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 1, no afatinib was administered and PK parameters of vinorelbine on day 1 were treated as “without afatinib”."
856589|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856615|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
856616|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856617|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
856590|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856591|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856592|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856593|NCT01214616|O4|Outcome|Afatinib 40 mg Without Vinorelbine|"Afatinib 40 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856594|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine|"Afatinib 40 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856637|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.~Permacol Surgical Implant: Permacol Surgical Implant"
856758|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856595|NCT01214616|O2|Outcome|Afatinib 20 mg Without Vinorelbine|"Afatinib 20 mg oral administration once a day without vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856596|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine|"Afatinib 20 mg oral administration once a day with vinorelbine intravenous injection weekly.~All patient was assigned as “20 mg afatinib with vinorelbine 25 mg/m2” or “40 mg afatinib with vinorelbine 20 mg/m2” or “40 mg afatinib with vinorelbine 25 mg/m2”.~On day 21 (after 20 doses of afatinib), 6 days passed after last vinorelbine administration (day 15) and PK parameters of afatinib on day 21 were treated as “without vinorelbine” because no large effect of vinorelbine is expected from PK point of view."
856597|NCT01214616|O4|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
856598|NCT01214616|O3|Outcome|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
856599|NCT01214616|O2|Outcome|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856600|NCT01214616|O1|Outcome|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856601|NCT01214616|E4|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 3)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly; allowed for vinorelbine dose to be skipped for Common Toxicity Criteria for Adverse Effects (CTCAE) Grade 2 or worse neutropenia or thrombocytopenia
856602|NCT01214616|E3|Reported Event|Afatinib 40 mg With Vinorelbine 20 mg/m^2 (Cohort 2a)|Afatinib 40 mg oral administration once a day with vinorelbine 20 mg/m^2 intravenous injection weekly
856603|NCT01214616|E2|Reported Event|Afatinib 40 mg With Vinorelbine 25 mg/m^2 (Cohort 2)|Afatinib 40 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856604|NCT01214616|E1|Reported Event|Afatinib 20 mg With Vinorelbine 25 mg/m^2 (Cohort 1)|Afatinib 20 mg oral administration once a day with vinorelbine 25 mg/m^2 intravenous injection weekly
856605|NCT01214434|B3|Baseline|Total|Total of all reporting groups
856606|NCT01214434|B2|Baseline|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856607|NCT01214434|B1|Baseline|Bland Emollient|Bland emollient : Eucerin cream twice daily
856608|NCT01214434|P2|Participant Flow|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856609|NCT01214434|P1|Participant Flow|Bland Emollient|Bland emollient : Eucerin cream twice daily
856610|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856611|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
856612|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856613|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
856614|NCT01214434|O2|Outcome|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856621|NCT01214434|O1|Outcome|Bland Emollient|Bland emollient : Eucerin cream twice daily
856622|NCT01214434|E2|Reported Event|Promiseb Topical Cream|Promiseb Topical Cream : topical non steroidal cream, twice daily
856623|NCT01214434|E1|Reported Event|Bland Emollient|Bland emollient : Eucerin cream twice daily
856624|NCT01214395|B1|Baseline|Tea Tree Oil Application|tea tree oil medication group
856625|NCT01214395|P1|Participant Flow|Tea Tree Oil Application|tea tree oil medication group
856626|NCT01214395|O1|Outcome|Did Not Have Staph. Aureus Infection|No exit site infection or peritonitis with Staph. aureus
856627|NCT01214395|O1|Outcome|Tea Tree Oil|tea tree oil application
856628|NCT01214395|E1|Reported Event|Tea Tree Oil Application|tea tree oil medication group
856629|NCT01214330|B1|Baseline|Solopap|females, age >18, without severe hand arthritis
856630|NCT01214330|P1|Participant Flow|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
856631|NCT01214330|O1|Outcome|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
856632|NCT01214330|E1|Reported Event|Self Pap Smear|"SoloPap: Patient-Collected Cervical Papanicolaou Smears~Self Pap Smear"
856633|NCT01214252|B1|Baseline|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
856634|NCT01214252|P1|Participant Flow|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
856635|NCT01214252|O1|Outcome|Permacol Patients|"Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.~Permacol Surgical Implant: Permacol Surgical Implant"
856636|NCT01214252|O1|Outcome|Permacol Patients|"Total (confirmed or unconfrimed) hernia or hernia recurrence at the repair site by year (# and percentage).~Unconfirmed hernia or recurrence reported by the subject is defined by confirmation of hernia symptoms based on results of the Symptoms questionnaire but not confirmed by clinical assessment by a surgeon or medical chart review"
856638|NCT01214252|E1|Reported Event|Permacol Patients|Patients who have undergone surgical repair of their abdominal wall defect with Permacol Surgical Implants with at least 12 months follow up.
856639|NCT01214239|B3|Baseline|Total|Total of all reporting groups
856640|NCT01214239|B2|Baseline|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856641|NCT01214239|B1|Baseline|Placebo|Placebo
856642|NCT01214239|P2|Participant Flow|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856643|NCT01214239|P1|Participant Flow|Placebo|Placebo
856644|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856645|NCT01214239|O1|Outcome|Placebo|Placebo
856646|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856647|NCT01214239|O1|Outcome|Placebo|Placebo
856648|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856649|NCT01214239|O1|Outcome|Placebo|Placebo
856650|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856651|NCT01214239|O1|Outcome|Placebo|Placebo
856652|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856653|NCT01214239|O1|Outcome|Placebo|Placebo
856654|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856655|NCT01214239|O1|Outcome|Placebo|Placebo
856656|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856657|NCT01214239|O1|Outcome|Placebo|Placebo
856658|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856659|NCT01214239|O1|Outcome|Placebo|Placebo
856660|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856661|NCT01214239|O1|Outcome|Placebo|Placebo
856662|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856663|NCT01214239|O1|Outcome|Placebo|Placebo
856664|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856665|NCT01214239|O1|Outcome|Placebo|Placebo
856666|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856667|NCT01214239|O1|Outcome|Placebo|Placebo
856668|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856669|NCT01214239|O1|Outcome|Placebo|Placebo
856670|NCT01214239|O2|Outcome|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856671|NCT01214239|O1|Outcome|Placebo|Placebo
856672|NCT01214239|E2|Reported Event|Linagliptin 5mg|Linagliptin 5mg, once daily tablets, oral
856673|NCT01214239|E1|Reported Event|Placebo|Placebo
856674|NCT01214187|B3|Baseline|Total|Total of all reporting groups
856675|NCT01214187|B2|Baseline|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856676|NCT01214187|B1|Baseline|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856677|NCT01214187|P2|Participant Flow|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856678|NCT01214187|P1|Participant Flow|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856679|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856680|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856681|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856682|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856683|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856684|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856685|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856686|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856687|NCT01214187|O2|Outcome|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856688|NCT01214187|O1|Outcome|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856689|NCT01214187|E2|Reported Event|Oxygen 21%|Oxygen: Room air oxygen concentrations will be administered as placebo
856690|NCT01214187|E1|Reported Event|Carbon Monoxide Inhalation|"The primary intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.~inhaled carbon monoxide: The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment."
856705|NCT01214161|B2|Baseline|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856706|NCT01214161|B1|Baseline|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856707|NCT01214161|P2|Participant Flow|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856708|NCT01214161|P1|Participant Flow|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856709|NCT01214161|O2|Outcome|Providers|The healthcare provider placing the IUD on that particular participant.
856710|NCT01214161|O1|Outcome|Participants|The cohort of all 200 women having their IUD inserted.
856711|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856734|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856735|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856736|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856737|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
878859|NCT01151436|O1|Outcome|Hyaluronic Acid|
856712|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856713|NCT01214161|O2|Outcome|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856714|NCT01214161|O1|Outcome|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856759|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856760|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856761|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856762|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856763|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856715|NCT01214161|E2|Reported Event|Placebo Gel (Surgilube)|"This group will be randomized to having the intervention with the placebo surgilube gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856716|NCT01214161|E1|Reported Event|Lidocaine Gel|"This group will be those randomized to receiving the intervention with 2% lidocaine gel.~2% lidocaine gel: Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
856717|NCT01214109|B1|Baseline|All Subjects|24 subjects were equally randomised to one of two groups / sequences, and in general terms, ABCD or BADC. Hence, 12 subjects were in group ABCD and 12 in BADC. All 24 subjects received all treatments, A, B, C, D. The numbers presented are by overall treatment.
856718|NCT01214109|P4|Participant Flow|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856719|NCT01214109|P3|Participant Flow|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856720|NCT01214109|P2|Participant Flow|0.125 mg t.i.d. Immediate Release (IR)|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856721|NCT01214109|P1|Participant Flow|0.375 mg q.d.Extended Release (ER)|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856722|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856723|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856724|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856725|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856726|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856727|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856728|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856729|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856730|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856731|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856732|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856733|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
878860|NCT01151436|O1|Outcome|Hyaluronic Acid|
856738|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856739|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856740|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856741|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856742|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856743|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856744|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856745|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856746|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856747|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856748|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856749|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856750|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856751|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856752|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856753|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856754|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856755|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856756|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856764|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856765|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856766|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856767|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856768|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856769|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856770|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856771|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856772|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856773|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856774|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856775|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856776|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856777|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856778|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856779|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856780|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856781|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856782|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856783|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856784|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856785|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856786|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856787|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856788|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856789|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856790|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856791|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856792|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856793|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856794|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856795|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856796|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856797|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
878861|NCT01151436|O1|Outcome|Hyaluronic Acid|
856798|NCT01214109|O4|Outcome|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856799|NCT01214109|O3|Outcome|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856800|NCT01214109|O2|Outcome|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856801|NCT01214109|O1|Outcome|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856802|NCT01214109|E7|Reported Event|0.5 mg t.i.d. IR|0.5mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856803|NCT01214109|E6|Reported Event|0.125 mg t.i.d. IR|0.125mg thrice daily (t.i.d) of immediate release (IR) tablet of pramipexole
856804|NCT01214109|E5|Reported Event|0.375 mg q.d.ER Down-titration|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856805|NCT01214109|E4|Reported Event|0.75 mg q.d. ER Down-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856806|NCT01214109|E3|Reported Event|1.5 mg q.d. ER|1.5mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856807|NCT01214109|E2|Reported Event|0.75 mg q.d. ER Up-titration|0.75mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856808|NCT01214109|E1|Reported Event|0.375 mg q.d.ER|0.375mg once daily (q.d.) of oral extended release (ER) tablet of pramipexole
856809|NCT01214083|B4|Baseline|Total|Total of all reporting groups
856810|NCT01214083|B3|Baseline|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856811|NCT01214083|B2|Baseline|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856812|NCT01214083|B1|Baseline|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856813|NCT01214083|P3|Participant Flow|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856814|NCT01214083|P2|Participant Flow|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856977|NCT01213264|B3|Baseline|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
856815|NCT01214083|P1|Participant Flow|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856816|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856817|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856818|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856819|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856820|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856821|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856822|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856823|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856824|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856825|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856826|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856827|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856828|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856829|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856830|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856831|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856832|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856833|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856834|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856835|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856836|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856837|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856838|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856839|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856840|NCT01214083|O3|Outcome|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856841|NCT01214083|O2|Outcome|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856842|NCT01214083|O1|Outcome|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856843|NCT01214083|E3|Reported Event|Low-dose Naltrexone (50 mg) Alone|Low-dose naltrexone (50 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856844|NCT01214083|E2|Reported Event|High-dose Naltrexone (150 mg) Alone|High-dose naltrexone (150 mg) alone: All subjects will be evaluated weekly for 12 weeks.
856845|NCT01214083|E1|Reported Event|N-acetylcysteine + High-dose Naltrexone (150 mg)|N-acetylcysteine + high-dose naltrexone (150 mg): All subjects will be evaluated weekly for 12 weeks.
856846|NCT01213966|B5|Baseline|Total|Total of all reporting groups
856847|NCT01213966|B4|Baseline|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
856848|NCT01213966|B3|Baseline|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
856849|NCT01213966|B2|Baseline|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
856850|NCT01213966|B1|Baseline|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
856851|NCT01213966|P4|Participant Flow|1200 mg OZ439 po Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.received single dose
856852|NCT01213966|P3|Participant Flow|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
856853|NCT01213966|P2|Participant Flow|400 mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg), patients in Cohort 2 received 400 mg OZ439, patients in Cohort 3 received 200 mg OZ439, and patients in Cohort 4 received 1200 mg OZ439.
856854|NCT01213966|P1|Participant Flow|800 mg OZ439 po Single Dose|Cohort 1 received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients was made following a study cohort review
856855|NCT01213966|O4|Outcome|1200 mg OZ439 po Single Dose|"Ultimately, after review of the data from Cohort 1 (800 mg), from Cohort 2 (400 mg), and Cohort 3 (200 mg), patients in Cohort 4 received a single dose of 1200 mg OZ439.~It was decided not to proceed with a fifth cohort and no further patients were enrolled."
860435|NCT01200602|B3|Baseline|Total|Total of all reporting groups
856856|NCT01213966|O3|Outcome|200mg OZ439 p.o. Single Dose|Ultimately, after review of the data from Cohort 1 (800 mg) and data from Cohort 2 (400 mg), patients in Cohort 3 received a single dose of 200 mg OZ439.
856857|NCT01213966|O2|Outcome|400 mg OZ439 p.o. Single Dose|After review of the data from Cohort 1 (800 mg), patients in Cohort 2 received a single dose of 400 mg OZ439.
856858|NCT01213966|O1|Outcome|800 mg OZ439 po Single Dose|The first cohort received a dose of 800 mg. The decision to decrease and/or increase the dose (within a 100 mg to 1600 mg range) in each next cohort of patients with either P. falciparum or P. vivax malaria, was made following a study cohort review of the safety data, drug exposure levels, and the PRR over 24 hours after the investigational product administration (PRR24) obtained from the previous cohort.
856859|NCT01213966|E4|Reported Event|Cohort 4 - OZ439 1200mg|1200 mg OZ439 po single dose
856860|NCT01213966|E3|Reported Event|Cohort 3 - OZ439 200mg|200mg OZ439 p.o. single dose
856861|NCT01213966|E2|Reported Event|Cohort 2 - OZ439 400mg|400 mg OZ439 p.o. single dose
856862|NCT01213966|E1|Reported Event|Cohort 1 - OZ439 800mg|800 mg OZ439 po single dose
856863|NCT01213836|B3|Baseline|Total|Total of all reporting groups
856864|NCT01213836|B2|Baseline|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
856865|NCT01213836|B1|Baseline|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
856866|NCT01213836|P2|Participant Flow|First Seroquel IR Then Seroquel XR|Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days
856867|NCT01213836|P1|Participant Flow|First Seroquel XR Then Seroquel IR|Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days
856868|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
856869|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
856870|NCT01213836|O2|Outcome|Seroquel IR|Patients treated with at least one dose of Seroquel IR
856871|NCT01213836|O1|Outcome|Seroquel XR|Patients treated with at least one dose of Seroquel XR
856872|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
856873|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
856874|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
856875|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
856876|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
856877|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
856878|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel IR in arm XR-IR and arm IR-XR.
856879|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
856880|NCT01213836|O2|Outcome|Seroquel IR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
856881|NCT01213836|O1|Outcome|Seroquel XR|Patients that took Seroquel XR in arm XR-IR and arm IR-XR.
856882|NCT01213836|E2|Reported Event|Seroquel IR|Patients treated with at least one dose of Seroquel IR
856883|NCT01213836|E1|Reported Event|Seroquel XR|Patients treated with at least one dose of Seroquel XR
856884|NCT01213823|B3|Baseline|Total|Total of all reporting groups
856885|NCT01213823|B2|Baseline|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
857244|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
856886|NCT01213823|B1|Baseline|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
856887|NCT01213823|P2|Participant Flow|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
856888|NCT01213823|P1|Participant Flow|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
856889|NCT01213823|O2|Outcome|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
856912|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856913|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856890|NCT01213823|O1|Outcome|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
856891|NCT01213823|E2|Reported Event|Controls|Controls were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) without a diagnosis of severe hepatic injury.
856892|NCT01213823|E1|Reported Event|Cases|Potential cases were to be defined as participants with invasive candidiasis (candidiasis of the lung, disseminated candidiasis, candidal endocarditis, candidal meningitis, candidal enteritis, or candidiasis of unspecified site) with severe hepatic injury (acute/subacute necrosis of liver, hepatic coma, hepatorenal syndrome, or hepatitis unspecified) classified into one of the following categories: 1) acute liver failure (associated with encephalopathy and/or coagulopathy in absence of underlying liver disease); 2) Hy's Law Criteria (serum alanine transaminase [ALT] levels greater than [>]3 times the upper limit of normal [xULN] and total bilirubin >2 xULN, with absence of alkaline phosphatase elevation; 3) serum ALT levels greater than or equal to (≥)10 xULN; 4) ALT levels >3 xULN and less than (<)10 xULN; or 5) as determined by clinician.
856893|NCT01213706|B1|Baseline|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
856894|NCT01213706|P1|Participant Flow|SHAM WBPA Then WBPA|
856895|NCT01213706|O2|Outcome|Sham WBPA|Subjects will be resting on the platform without any WBPA.
856896|NCT01213706|O1|Outcome|WBPA|Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
856897|NCT01213706|E2|Reported Event|Sham WBPA|"The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.~Sham WBPA: The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge."
856898|NCT01213706|E1|Reported Event|Whole Body Periodic Acceleration (WBPA)|"Whole Body Periodic Acceleration (WBPA) in spinal axis (pGz) will be administered with a platform that resembles a bed. The platform moves in a repetitive head-to-foot direction at 140 times a minute, producing 0.22 g. These settings have been shown to release NO into the circulation.~Whole Body Periodic Acceleration (WBPA): Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min."
856899|NCT01213589|B4|Baseline|Total|Total of all reporting groups
856900|NCT01213589|B3|Baseline|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856901|NCT01213589|B2|Baseline|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
857006|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
856902|NCT01213589|B1|Baseline|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856903|NCT01213589|P3|Participant Flow|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856904|NCT01213589|P2|Participant Flow|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856905|NCT01213589|P1|Participant Flow|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856906|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856907|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856908|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856909|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856910|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856911|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856947|NCT01213576|E4|Reported Event|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
856914|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856915|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856916|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856917|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856918|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856919|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856920|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856921|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856922|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856923|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856924|NCT01213589|O3|Outcome|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856925|NCT01213589|O2|Outcome|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
856926|NCT01213589|O1|Outcome|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856927|NCT01213589|E3|Reported Event|Chronic|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a chronic Type B dissection.
856928|NCT01213589|E2|Reported Event|Sub-acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for a sub-acute Type B dissection.
857007|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
856929|NCT01213589|E1|Reported Event|Acute|Patients diagnosed with a descending thoracic aortic dissection and who are amenable to stent-graft operation. The patient had an indication for treatment by either endovascular stent graft implantation for an acute Type B dissection.
856930|NCT01213576|B5|Baseline|Total|Total of all reporting groups
856931|NCT01213576|B4|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Bi-annual|Albendazole 800mg and ivermectin 400mcg/kg given twice a year
856932|NCT01213576|B3|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Biannual|Albendazole 400mg and ivermectin 200mcg/kg given twice a year
856933|NCT01213576|B2|Baseline|Albendazole 800mg and Ivermectin 400mcg/kg Annual|Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg orally given once a year
856934|NCT01213576|B1|Baseline|Albendazole 400mg and Ivermectin 200mcg/kg Annual|Albendazole 400mg and ivermectin 200mcg/kg: 400 mg orally given once a year
856935|NCT01213576|P4|Participant Flow|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
856936|NCT01213576|P3|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
856937|NCT01213576|P2|Participant Flow|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
856938|NCT01213576|P1|Participant Flow|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
856939|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
856940|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
856941|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
856942|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
856943|NCT01213576|O4|Outcome|Albendazole 800mg and Ivermectin 400mcg /kg Bi-annually|"Twice a year~Albendazole 800mg and ivermectin 400mcg/kg given twice a year"
856944|NCT01213576|O3|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
856945|NCT01213576|O2|Outcome|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
856946|NCT01213576|O1|Outcome|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
856948|NCT01213576|E3|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Biannually|"Twice a year~albendazole 400mg and ivermectin 200mcg/kg given twice a year"
856949|NCT01213576|E2|Reported Event|Albendazole 800mg and Ivermectin 400mcg/kg Annually|"Once a year treatment~Albendazole and ivermectin: albendazole 800 mg and ivermectin 400mg oral"
856950|NCT01213576|E1|Reported Event|Albendazole 400mg and Ivermectin 200mcg/kg Annually|"Once a year treatment~Albendazole 400mg and ivermectin 200mcg/kg: 400 mg oral"
856951|NCT01213329|B3|Baseline|Total|Total of all reporting groups
856952|NCT01213329|B2|Baseline|Donor Comparison|
856953|NCT01213329|B1|Baseline|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
856954|NCT01213329|P2|Participant Flow|Donor Comparison|
856955|NCT01213329|P1|Participant Flow|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
856956|NCT01213329|O2|Outcome|Donor Comparison|
856957|NCT01213329|O1|Outcome|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
856958|NCT01213329|E2|Reported Event|Donor Comparison|
856959|NCT01213329|E1|Reported Event|Alemtuzumab (Phase I)|"All transplant recipients received one 30mg dose (intravenous IV push)of Alemtuzmab in the operating room per Standard of Care."
856960|NCT01213316|B1|Baseline|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856961|NCT01213316|P1|Participant Flow|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856962|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856963|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856964|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856965|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856966|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856967|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856968|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
856969|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
856970|NCT01213316|O1|Outcome|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard clinical practice for HIV-1 patients in Germany.
856971|NCT01213316|O1|Outcome|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856972|NCT01213316|O1|Outcome|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856973|NCT01213316|E3|Reported Event|Aging Participants|HIV-1 infected participants >=50 years old received raltegravir 400 mg tablet orally twice daily for 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856974|NCT01213316|E2|Reported Event|Initial Cohort Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856975|NCT01213316|E1|Reported Event|Overall Participants|HIV-1 infected participants received raltegravir 400 mg tablet orally twice daily for 96 weeks (Initial Cohort), 144 weeks (Prolonged Cohort) or 48 weeks (Amendment Cohort) in combination with other antiretroviral drugs under conditions representative of standard of clinical practice for HIV-1 patients in Germany.
856976|NCT01213264|B4|Baseline|Total|Total of all reporting groups
856978|NCT01213264|B2|Baseline|Sugammadex|Participants administered sugammadex for NMB reversal
856979|NCT01213264|B1|Baseline|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
856980|NCT01213264|P3|Participant Flow|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
856981|NCT01213264|P2|Participant Flow|Sugammadex|Participants administered sugammadex for NMB reversal
856982|NCT01213264|P1|Participant Flow|Spontaneous Reversal|Participants whose reversal from neuromuscular blockade (NMB) was spontaneous (no reversal agent used)
856983|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
856984|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
856985|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
856986|NCT01213264|O2|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
856987|NCT01213264|O1|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
856988|NCT01213264|O1|Outcome|Total Study Population|Total population of study participants who received an NMBA or NMB-reversal agent
856989|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
856990|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
856991|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
856992|NCT01213264|O3|Outcome|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
856993|NCT01213264|O2|Outcome|Sugammadex|Participants administered sugammadex for NMB reversal
856994|NCT01213264|O1|Outcome|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
856995|NCT01213264|E3|Reported Event|Other Reversal Agents|Participants administered any other agent (other than sugammadex) for NMB reversal
856996|NCT01213264|E2|Reported Event|Sugammadex|Participants administered sugammadex for NMB reversal
856997|NCT01213264|E1|Reported Event|Spontaneous Reversal|Participants whose reversal from NMB was spontaneous (no reversal agent used)
856998|NCT01213251|B4|Baseline|Total|Total of all reporting groups
856999|NCT01213251|B3|Baseline|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
857000|NCT01213251|B2|Baseline|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
857001|NCT01213251|B1|Baseline|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
857002|NCT01213251|P3|Participant Flow|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
857003|NCT01213251|P2|Participant Flow|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
857004|NCT01213251|P1|Participant Flow|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
857005|NCT01213251|O1|Outcome|All Subjects|All subjects randomized in the study (either control, single pacing or dual pacing). For the patients randomized to single or dual site, only patients with successful implant are included.
878862|NCT01151436|O1|Outcome|Hyaluronic Acid|
857008|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
857009|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
857010|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
857011|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
857012|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
857013|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
857014|NCT01213251|O3|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
857015|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that were successfully be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
857016|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that were successfully implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
857017|NCT01213251|O2|Outcome|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
857018|NCT01213251|O1|Outcome|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
857019|NCT01213251|O2|Outcome|Control|Subjects randomized to the group that did not have a device implanted and was managed according to conventional medical management.
857020|NCT01213251|O1|Outcome|Pooled Pacing|Subjects successfully implanted with a CRT-D device (either single or dual pacing).
857021|NCT01213251|E3|Reported Event|Control|Subjects randomized to the group that will not have a device implanted and will be managed according to conventional medical management.
857022|NCT01213251|E2|Reported Event|Dual Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
857023|NCT01213251|E1|Reported Event|Single Site Pacing|Subjects randomized to the group that will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
857024|NCT01213199|B1|Baseline|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
857025|NCT01213199|P1|Participant Flow|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
857026|NCT01213199|O1|Outcome|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
857027|NCT01213199|E1|Reported Event|Differin® 0.3% Gel|"Differin® 0.3% Gel Adapalene 0.3%~Topical to the face Once daily application in the evening for the first 4 weeks and twice daily application in the morning and in the evening for the following 20 weeks."
857028|NCT01213173|B3|Baseline|Total|Total of all reporting groups
857029|NCT01213173|B2|Baseline|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857030|NCT01213173|B1|Baseline|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857031|NCT01213173|P2|Participant Flow|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857032|NCT01213173|P1|Participant Flow|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857033|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857034|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857035|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857036|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857037|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857038|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857039|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857063|NCT01213043|B1|Baseline|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
857040|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857041|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857042|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857043|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857044|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857045|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857046|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857047|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857048|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
867682|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
857049|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857050|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857051|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857052|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857053|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857054|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857055|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857056|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857057|NCT01213173|O2|Outcome|Arm 2 - Experimental|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857058|NCT01213173|O1|Outcome|Arm 1 - Active Comparator|Drug: Succinate Metoprolol (Betaloc ZOK®) Treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857059|NCT01213173|E2|Reported Event|Experimental|lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
857060|NCT01213173|E1|Reported Event|Active Comparator|lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
857061|NCT01213043|B3|Baseline|Total|Total of all reporting groups
857062|NCT01213043|B2|Baseline|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
857064|NCT01213043|P2|Participant Flow|120 mg/kg - 60 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 120 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 60 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
857065|NCT01213043|P1|Participant Flow|60 mg/kg - 120 mg/kg Prolastin-C Treatment Sequence|Weekly infusions of 60 mg/kg Prolastin-C for 8 weeks followed by a 2-week off-treatment washout period followed by weekly infusions of 120 mg/kg Prolastin-C for 8 weeks (total of 16 treatment weeks)
857066|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857067|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857068|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857069|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857070|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857071|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857072|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857073|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857074|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857075|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857076|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857077|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857078|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857079|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857080|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857081|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857082|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857083|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857084|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857085|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857086|NCT01213043|O2|Outcome|120 mg/kg Prolastin-C|
857087|NCT01213043|O1|Outcome|60 mg/kg Prolastin-C|
857088|NCT01213043|E2|Reported Event|120 mg/kg Prolastin-C|
857089|NCT01213043|E1|Reported Event|60 mg/kg Prolastin-C|
857090|NCT01212991|B3|Baseline|Total|Total of all reporting groups
857091|NCT01212991|B2|Baseline|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857092|NCT01212991|B1|Baseline|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857093|NCT01212991|P2|Participant Flow|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857094|NCT01212991|P1|Participant Flow|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857095|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857096|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857097|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857098|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857099|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857100|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857101|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857102|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857103|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857104|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857105|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857106|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857107|NCT01212991|O2|Outcome|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857108|NCT01212991|O1|Outcome|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857109|NCT01212991|E2|Reported Event|Placebo|Participants received placebo, administered as four capsules, once per day by mouth.
857110|NCT01212991|E1|Reported Event|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth.
857111|NCT01212874|B3|Baseline|Total|Total of all reporting groups
857112|NCT01212874|B2|Baseline|Esmolol|"esmolol infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension."
857113|NCT01212874|B1|Baseline|Nitroglycerin|"nitroglycerin infusion titrated to control hypertension from anesthesia induction to initiation of cardiopulmonary bypass~nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery."
857114|NCT01212874|P2|Participant Flow|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
857115|NCT01212874|P1|Participant Flow|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
857116|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
857117|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
857118|NCT01212874|O2|Outcome|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
857119|NCT01212874|O1|Outcome|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
857786|NCT01211184|B1|Baseline|Fasting|patients undergo surgery in the fasting state
857120|NCT01212874|E2|Reported Event|Nitroglycerin|nitroglycerin: nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
857121|NCT01212874|E1|Reported Event|Esmolol|esmolol: esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
857122|NCT01212770|B4|Baseline|Total|Total of all reporting groups
857123|NCT01212770|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857124|NCT01212770|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857125|NCT01212770|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857126|NCT01212770|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
857127|NCT01212770|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
857128|NCT01212770|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
857129|NCT01212770|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
857130|NCT01212770|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
857131|NCT01212770|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
857132|NCT01212770|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
857133|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
859763|NCT01203072|B4|Baseline|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
857134|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857135|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857136|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857137|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857138|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857139|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857140|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857141|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857142|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857143|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857144|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857145|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857146|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857147|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857148|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857149|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857150|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857151|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857152|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857153|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857154|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857155|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857156|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857157|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857158|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857159|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857160|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857161|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857162|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857163|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857164|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857165|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857166|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857167|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857168|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857169|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857170|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857171|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857172|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857173|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857174|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857175|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
867694|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
857176|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857177|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857178|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857179|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857180|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857181|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857182|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857183|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857184|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857185|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857186|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857187|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857188|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857189|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857190|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857191|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857192|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857193|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857194|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857195|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857196|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857197|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857198|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857199|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857243|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857200|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857201|NCT01212770|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857202|NCT01212770|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857203|NCT01212770|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857204|NCT01212770|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857205|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857206|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857207|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857208|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857209|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857210|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857211|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857212|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857213|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857214|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857215|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857216|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857217|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857218|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857219|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857220|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857221|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857222|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857223|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857224|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857225|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857226|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857227|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857228|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857229|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857230|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857231|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857232|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857233|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857234|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857235|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857236|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857237|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857238|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857239|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857240|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857241|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857242|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857245|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857246|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857247|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857248|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857249|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857250|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857251|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857252|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857253|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857254|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857255|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857256|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857257|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857258|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857259|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857260|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871052|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
857261|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857262|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857263|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857264|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857265|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857266|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857267|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857268|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857269|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857270|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857271|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857272|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857273|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857274|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857275|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857276|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857277|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857278|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857279|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857280|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857281|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857282|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857283|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857284|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857285|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857286|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857287|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857288|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857289|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857290|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857291|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857292|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857293|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857294|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857295|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857296|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857297|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857298|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857299|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857300|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857301|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857302|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857303|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857304|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857305|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857306|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857307|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
859764|NCT01203072|B3|Baseline|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
857308|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857309|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857310|NCT01212770|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857311|NCT01212770|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857312|NCT01212770|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857313|NCT01212770|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
857314|NCT01212770|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
857315|NCT01212770|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
857316|NCT01212770|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
857317|NCT01212770|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
857318|NCT01212757|B4|Baseline|Total|Total of all reporting groups
857319|NCT01212757|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857320|NCT01212757|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857321|NCT01212757|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857322|NCT01212757|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
857323|NCT01212757|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
857324|NCT01212757|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
857325|NCT01212757|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
857326|NCT01212757|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
857327|NCT01212757|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 24-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
857328|NCT01212757|P1|Participant Flow|Placebo|Participants initially randomized to placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
857329|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
878863|NCT01151436|O1|Outcome|Hyaluronic Acid|
857330|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857331|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857332|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857333|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857334|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857335|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857336|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857337|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857338|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857339|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857340|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857341|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857342|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857343|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857344|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857345|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857346|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857389|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857347|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857348|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857349|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857350|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857351|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857352|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857353|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857354|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857355|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857356|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857357|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857358|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857359|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857360|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857361|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857362|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857363|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857364|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857365|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857366|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857367|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857368|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857369|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857370|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857787|NCT01211184|P3|Participant Flow|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
857371|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857372|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857373|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857374|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857375|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857376|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857377|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857378|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857379|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857380|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857381|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857382|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857383|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857384|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857385|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857386|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857387|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857388|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857390|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857391|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857392|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857393|NCT01212757|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857394|NCT01212757|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857395|NCT01212757|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
857396|NCT01212757|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
857397|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857398|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857399|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857400|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857401|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857402|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857403|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857404|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857405|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857406|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857407|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857408|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857409|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857410|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857411|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857412|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857413|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
878864|NCT01151436|O1|Outcome|Hyaluronic Acid|
857414|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857415|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857416|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857417|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857418|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857419|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857420|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857421|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857422|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857423|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857424|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857425|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857426|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857427|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857428|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857429|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857430|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857431|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857432|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857433|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857434|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857435|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857436|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857437|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857438|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857439|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857440|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857441|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857442|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857443|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857444|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857445|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857446|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857447|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857448|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857449|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857450|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857451|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857452|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857453|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857454|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857455|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
878865|NCT01151436|O1|Outcome|Hyaluronic Acid|
857456|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857457|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857458|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857459|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857460|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857461|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857462|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857463|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857464|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857465|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857466|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857467|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857468|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857469|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857470|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857471|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857472|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857473|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857474|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857475|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857605|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857476|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857477|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857478|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857479|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857480|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857481|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857482|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857483|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857484|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857485|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857486|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857487|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857488|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857489|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857490|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857491|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857492|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
857493|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857494|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857495|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857496|NCT01212757|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
857497|NCT01212757|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
857498|NCT01212757|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
857499|NCT01212757|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
857500|NCT01212757|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
857788|NCT01211184|P2|Participant Flow|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
857501|NCT01212757|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
857502|NCT01212757|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
857503|NCT01212757|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
857504|NCT01212627|B1|Baseline|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
857505|NCT01212627|P1|Participant Flow|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
857506|NCT01212627|O1|Outcome|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
857507|NCT01212627|E1|Reported Event|Ridaforolimus,|"Ridaforolimus: 20mg Daily, 5 days each week, on a 28 day cycle until progression~Ridaforolimus: Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle~Ridaforolimus"
857508|NCT01212484|B1|Baseline|All Study Subjects|
857509|NCT01212484|P2|Participant Flow|Carbidopa (First), Placebo (Second)|Subjects will be given Carbidopa for a 4 week period followed by placebo for a 4 week period.
857510|NCT01212484|P1|Participant Flow|Placebo (First), Carbidopa (Second)|Subjects will be given placebo first (4 weeks), followed by carbidopa (4 weeks).
857511|NCT01212484|O2|Outcome|Placebo|
857512|NCT01212484|O1|Outcome|Carbidopa|
857513|NCT01212484|O2|Outcome|Placebo|
857514|NCT01212484|O1|Outcome|Carbidopa|
857515|NCT01212484|O2|Outcome|Placebo|
857516|NCT01212484|O1|Outcome|Carbidopa|
857517|NCT01212484|E2|Reported Event|Placebo|"Placebo~Placebo : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
857518|NCT01212484|E1|Reported Event|Carbidopa|"carbidopa~Carbidopa : The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design."
857519|NCT01212445|B4|Baseline|Total|Total of all reporting groups
857606|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857520|NCT01212445|B3|Baseline|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857521|NCT01212445|B2|Baseline|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857522|NCT01212445|B1|Baseline|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
857523|NCT01212445|P3|Participant Flow|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857524|NCT01212445|P2|Participant Flow|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857525|NCT01212445|P1|Participant Flow|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857526|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857527|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857528|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
857529|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857530|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857531|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
857532|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857789|NCT01211184|P1|Participant Flow|Fasting|patients undergo surgery in the fasting state
857533|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857534|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
857535|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857536|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857537|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857538|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857539|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857540|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857541|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857542|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857543|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
857544|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857607|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857608|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857545|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857546|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment
857547|NCT01212445|O3|Outcome|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857548|NCT01212445|O2|Outcome|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857549|NCT01212445|O1|Outcome|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857550|NCT01212445|E3|Reported Event|PEG + E 39.375 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as three sachets of PEG+E (39.375 g) dissolved in 375 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857551|NCT01212445|E2|Reported Event|PEG + E 26.25 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as two sachets of PEG+E (26.25 g) dissolved in 250 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857552|NCT01212445|E1|Reported Event|PEG + E 13.125 g|Participants received Polyethylene Glycol plus Electrolytes (PEG+E) as a single sachet of PEG+E (13.125 g) dissolved in 125 mL of non-carbonated water ingested orally with entire volume taken at one time on the day of open-label treatment.
857553|NCT01212302|B1|Baseline|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
857554|NCT01212302|P1|Participant Flow|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
857555|NCT01212302|O1|Outcome|Clopidogrel Low Response|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
857556|NCT01212302|E1|Reported Event|Aspirin, Clopidogrel|If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
857557|NCT01212185|B3|Baseline|Total|Total of all reporting groups
857558|NCT01212185|B2|Baseline|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
857790|NCT01211184|O3|Outcome|Nutrition Group|Drank a carbohydrate drink 800 ml in the evening before surgery and 400 ml 2 hrs before surgery
857559|NCT01212185|B1|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
857560|NCT01212185|P2|Participant Flow|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
857561|NCT01212185|P1|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 3 days"
857562|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
857563|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
857564|NCT01212185|O2|Outcome|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
857565|NCT01212185|O1|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
857566|NCT01212185|E2|Reported Event|Intranasal Oxytocin Spray|"Twice daily intranasal oxytocin spray~intranasal oxytocin spray: 6 insufflations (24 IU of oxytocin total) given twice daily for 3 days"
857567|NCT01212185|E1|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin.~intranasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily"
857568|NCT01212172|B1|Baseline|Side-by Side Comparsion of Soprano/SHR to Light Sheer|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.~LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
857569|NCT01212172|P2|Participant Flow|LightSheer Duet 810 nm Diode Laser|"Soprano and LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
857570|NCT01212172|P1|Participant Flow|Soprano Duet 810 nm Diode Laser|"Soprano Duet 810 nm diode laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
857609|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857610|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857611|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857612|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857571|NCT01212172|O2|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
857572|NCT01212172|O1|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
857573|NCT01212172|O2|Outcome|LightSheer|"LightSheer Duet 810 nm diode laser~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
857574|NCT01212172|O1|Outcome|Soprano/SHR|"Alma Soprano/SHR 810 nm Diode Laser~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
857575|NCT01212172|E2|Reported Event|Light Sheer 810 nm Diode Laser|"Light Sheer 810 nm Diode Laser~Left Axilla or Lower Leg~LightSheer: The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings."
857576|NCT01212172|E1|Reported Event|Soprano/SHR 810 nm Diode Laser|"Alma Soprano/SHR VS Light Sheer Duet 810 nm Diode Lasers~Right Axilla or Lower Leg~Soprano/SHR: For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time."
857577|NCT01212159|B3|Baseline|Total|Total of all reporting groups
857578|NCT01212159|B2|Baseline|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
857579|NCT01212159|B1|Baseline|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
857580|NCT01212159|P2|Participant Flow|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
857782|NCT01211197|E1|Reported Event|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857581|NCT01212159|P1|Participant Flow|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
857582|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
857583|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
857584|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
857585|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
857586|NCT01212159|O2|Outcome|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
857587|NCT01212159|O1|Outcome|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
857588|NCT01212159|E2|Reported Event|Self Monitoring Lipid Analyzer|"Self measured blood lipids using a home lipidometer, and telephone reporting of data to the clinical center.~Self Monitoring Lipid Analyzer: The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values."
857589|NCT01212159|E1|Reported Event|No Self Monitoring Device|Standard or usual care of high LDL including lab lipid profiles after treatment with statin therapy. No device or telemedicine education will be provided
857590|NCT01212094|B4|Baseline|Total|Total of all reporting groups
857591|NCT01212094|B3|Baseline|Baseline|Patients in their first year baseline prior to treatment phase
857592|NCT01212094|B2|Baseline|Rituximab|Group administered active drug
857593|NCT01212094|B1|Baseline|Placebo|Group administered placebo
857594|NCT01212094|P3|Participant Flow|Rituximab|Group administered active drug
857595|NCT01212094|P2|Participant Flow|Placebo|Group administered placebo
857596|NCT01212094|P1|Participant Flow|Baseline|Patients in their first year baseline prior to study drug phase
857597|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857598|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857599|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857600|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857601|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857602|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857603|NCT01212094|O2|Outcome|Rituximab|Group administered active drug
857604|NCT01212094|O1|Outcome|Placebo|Group administered placebo
857623|NCT01212094|E3|Reported Event|Baseline|Patients in their first year baseline prior to study drug phase
857624|NCT01212094|E2|Reported Event|Rituximab|Group who got active drug
857625|NCT01212094|E1|Reported Event|Placebo|Placebo group
857626|NCT01211873|B4|Baseline|Total|Total of all reporting groups
857627|NCT01211873|B3|Baseline|Dotarem 2 (Gadoterate Meglumine )|All children were assigned to Dotarem
857628|NCT01211873|B2|Baseline|Dotarem (Gadoterate Meglumine )|adults received Dotarem as 2:1 ratio compared to Magnevist.
857629|NCT01211873|B1|Baseline|Magnevist (Gadopentetate Dimeglumine)|adults received Magnevist as 1:2 ratio compared to Dotarem
857630|NCT01211873|P3|Participant Flow|Dotarem 2 (Gadoterate Meglumine )|Pediatric patients were assigned to Dotarem group only
857631|NCT01211873|P2|Participant Flow|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
857632|NCT01211873|P1|Participant Flow|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adult patients.
857633|NCT01211873|O2|Outcome|Dotarem (Gadoterate Meglumine ) PAIRED|all sequences pre and post injection wil be pooled as PAIRED
857634|NCT01211873|O1|Outcome|Dotarem (Gadoterate Meglumine ) PRE|any sequence acquired prior to injection will be pooled as PRE
857635|NCT01211873|E3|Reported Event|Dotarem 2 (Gadoterate Meglumine )|children were only assigned to Dotarem
857636|NCT01211873|E2|Reported Event|Magnevist (Gadopentetate Dimeglumine)|Dotarem and Magnevist were randomised as 2:1 ratio
857637|NCT01211873|E1|Reported Event|Dotarem (Gadoterate Meglumine )|Dotarem and Magnevist were randomised as 2:1 ratio for adults
857638|NCT01211769|B5|Baseline|Total|Total of all reporting groups
857639|NCT01211769|B4|Baseline|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
857640|NCT01211769|B3|Baseline|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
857641|NCT01211769|B2|Baseline|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857642|NCT01211769|B1|Baseline|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857643|NCT01211769|P4|Participant Flow|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
857644|NCT01211769|P3|Participant Flow|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
857645|NCT01211769|P2|Participant Flow|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857646|NCT01211769|P1|Participant Flow|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857647|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
857648|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
857649|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857650|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857651|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
857652|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
857653|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857654|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857655|NCT01211769|O4|Outcome|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
857656|NCT01211769|O3|Outcome|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
857657|NCT01211769|O2|Outcome|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857658|NCT01211769|O1|Outcome|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
859765|NCT01203072|B2|Baseline|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
857659|NCT01211769|E4|Reported Event|Naltrexone + PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone chlorhydrate 50 mg"
857660|NCT01211769|E3|Reported Event|PUFAs|"Polyunsaturated fatty acids (PUFAs): borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram; along with 1 gram of fish oil - rich in omega 3 PUFA;~Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;"
857661|NCT01211769|E2|Reported Event|Naltrexone|"Naltrexone chlorhydrate 50 mg~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857662|NCT01211769|E1|Reported Event|Placebo|"Naltrexone Placebo: pill with 50mg of talcum powder, identical to the pill of naltrexone;~Polyunsaturated fatty acids Placebo (PUFAs Placebo): yellow liquid paraffin identical to the pills of borage seed and fish oil."
857663|NCT01211730|B3|Baseline|Total|Total of all reporting groups
857664|NCT01211730|B2|Baseline|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857665|NCT01211730|B1|Baseline|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857666|NCT01211730|P2|Participant Flow|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857667|NCT01211730|P1|Participant Flow|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857668|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857669|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857670|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857671|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857672|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857673|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857674|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857675|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857676|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857677|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857678|NCT01211730|O2|Outcome|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857679|NCT01211730|O1|Outcome|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857680|NCT01211730|E2|Reported Event|180 Group|"Insulin treatment to target blood glucose at 180 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857681|NCT01211730|E1|Reported Event|140 Group|"Insulin treatment to target blood glucose at 140 mg/dl~Insulin: Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit."
857682|NCT01211665|B3|Baseline|Total|Total of all reporting groups
857683|NCT01211665|B2|Baseline|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857684|NCT01211665|B1|Baseline|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857685|NCT01211665|P2|Participant Flow|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857686|NCT01211665|P1|Participant Flow|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
858414|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
857687|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857688|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857689|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857690|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857691|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857692|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857693|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857694|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857695|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857696|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857697|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857783|NCT01211184|B4|Baseline|Total|Total of all reporting groups
857698|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857699|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857700|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857701|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857702|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857703|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857704|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857705|NCT01211665|O2|Outcome|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857706|NCT01211665|O1|Outcome|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857707|NCT01211665|E2|Reported Event|IVMP With Oral Prednisolone Taper|Intravenous methylprednisolone (IVMP) 1g/day for 6 days followed by an oral taper over 2 months. If necessary, additional cycles of 1 g IVMP daily for 3 to 5 days can be administered at any time.
857708|NCT01211665|E1|Reported Event|Pulsed IVMP|Intravenous methylprednisolone (IVMP) 1 g/day administered the first 3 days of each weekly cycle, and repeated for 3 additional cycles (totaling 4 cycles). If necessary, 2 additional weekly cycles of 1 g IVMP daily for 3 days can be administered at the discretion of the investigator.
857709|NCT01211613|B4|Baseline|Total|Total of all reporting groups
857710|NCT01211613|B3|Baseline|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
858415|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
857711|NCT01211613|B2|Baseline|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
857712|NCT01211613|B1|Baseline|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
857713|NCT01211613|P3|Participant Flow|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
857714|NCT01211613|P2|Participant Flow|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
857715|NCT01211613|P1|Participant Flow|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
857716|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
857717|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
857791|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of water 2 hrs before surgery
857718|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
857719|NCT01211613|O3|Outcome|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
857720|NCT01211613|O2|Outcome|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
857721|NCT01211613|O1|Outcome|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
857722|NCT01211613|E3|Reported Event|Standard Medical Care|"Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.~Standard Medical Care: Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated."
857723|NCT01211613|E2|Reported Event|Mechanical Manipulation|"Doctor of chiropractic will apply a mechanically-assisted thrust to the lumbar spine of research participants using the Activator IV Instrument.~Mechanically-assisted manipulation: Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants."
857724|NCT01211613|E1|Reported Event|Manual Manipulation|"Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.~Manual Manipulation: Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants."
857725|NCT01211535|B3|Baseline|Total|Total of all reporting groups
857726|NCT01211535|B2|Baseline|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857727|NCT01211535|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857728|NCT01211535|P2|Participant Flow|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857729|NCT01211535|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857730|NCT01211535|O2|Outcome|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857731|NCT01211535|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857732|NCT01211535|E2|Reported Event|ReNu Biotrue|ReNu Biotrue multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857733|NCT01211535|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose solution used with study contact lenses on a daily wear basis for 14 days
857734|NCT01211197|B1|Baseline|Study Overall|"An open label, randomised, three-way crossover study. The three treatments administered were~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~Fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~A washout period of at least 7 days was respected between drug administrations."
857735|NCT01211197|P6|Participant Flow|FDC Fed / Individual Tablets Fasted / FDC Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
857736|NCT01211197|P5|Participant Flow|FDC Fed / FDC Fasted / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
857737|NCT01211197|P4|Participant Flow|Individual Tablets Fasted / FDC Fed / FDC Fasted|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions"
857738|NCT01211197|P3|Participant Flow|Individual Tablets Fasted / FDC Fasted / FDC Fed|"Patients received the three treatments in the following order:~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
857739|NCT01211197|P2|Participant Flow|FDC Fasted / FDC Fed / Individual Tablets Fasted|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions"
857784|NCT01211184|B3|Baseline|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
857785|NCT01211184|B2|Baseline|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
857792|NCT01211184|O1|Outcome|Fasting|Fasting before surgery
857740|NCT01211197|P1|Participant Flow|FDC Fasted / Individual Tablets Fasted / FDC Fed|"Patients received the three treatments in the following order:~FDC tablet, containing 12.5mg empagliflozin (BI 10773) and 1000mg metformin, under fasted conditions~12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions~FDC tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions"
857741|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857742|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857743|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857744|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857745|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857746|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857747|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857748|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857749|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857750|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857751|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857752|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857753|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857754|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857755|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857756|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857757|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857758|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857759|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857760|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857761|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857762|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857763|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857764|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857765|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857766|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857767|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857768|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857769|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857770|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857771|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857772|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857773|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857774|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857775|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857776|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857777|NCT01211197|O3|Outcome|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fed conditions.
857778|NCT01211197|O2|Outcome|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
857779|NCT01211197|O1|Outcome|FDC Fasted|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857780|NCT01211197|E3|Reported Event|FDC Fed|A single fixed dose combination (FDC) tablet, containing 12.5mg empagliflozin and 1000mg metformin, under fasted conditions.
857781|NCT01211197|E2|Reported Event|Individual Tablets Fasted|12.5mg empa and 1000mg metformin individual-component tablets under fasted conditions.
884554|NCT01134276|B3|Baseline|Total|Total of all reporting groups
857793|NCT01211184|O3|Outcome|Nutrition Group|Patients drank 800 ml in the evening before surgery and 400 ml 2 hours before surgery of a commercially available carbohydrate drink (PreOp)
857794|NCT01211184|O2|Outcome|Water Group|Patients drank 800 ml of tap water 2 hrs before entering the operating room
857795|NCT01211184|O1|Outcome|Fasting Group|Patients did not ingest any drink or food from midnight before the surgery.
857796|NCT01211184|E3|Reported Event|Carbohydrate Drink|Patients undergo hip surgery after receiving 800 ml carbohydrate drink by mouth
857797|NCT01211184|E2|Reported Event|Water|Patients undergo hip surgery after receiving 800 ml water by mouth the evening before surgery
857798|NCT01211184|E1|Reported Event|Fasting|patients undergo surgery in the fasting state
857799|NCT01211145|B5|Baseline|Total|Total of all reporting groups
857800|NCT01211145|B4|Baseline|ZOMIG 5 mg|ZOMIG nasal spray
857801|NCT01211145|B3|Baseline|ZOMIG 2.5 mg|ZOMIG nasal spray
857802|NCT01211145|B2|Baseline|ZOMIG 0.5 mg|ZOMIG nasal spray
857803|NCT01211145|B1|Baseline|Placebo|Placebo to ZOMIG nasal spray
857804|NCT01211145|P4|Participant Flow|ZOMIG 5 mg|ZOMIG nasal spray
857805|NCT01211145|P3|Participant Flow|ZOMIG 2.5 mg|ZOMIG nasal spray
857806|NCT01211145|P2|Participant Flow|ZOMIG 0.5 mg|ZOMIG nasal spray
857807|NCT01211145|P1|Participant Flow|Placebo|Placebo to ZOMIG nasal spray
857808|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
857809|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
857810|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
857811|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
857812|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
857813|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
857814|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
857815|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
857816|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
857817|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
857818|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
857819|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
857820|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
857821|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
857822|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
857823|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
857824|NCT01211145|O4|Outcome|ZOMIG 5 mg|ZOMIG nasal spray
857825|NCT01211145|O3|Outcome|ZOMIG 2.5 mg|ZOMIG nasal spray
857826|NCT01211145|O2|Outcome|ZOMIG 0.5 mg|ZOMIG nasal spray
857827|NCT01211145|O1|Outcome|Placebo|Placebo to ZOMIG nasal spray
857837|NCT01211106|B2|Baseline|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
857838|NCT01211106|B1|Baseline|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
857839|NCT01211106|P2|Participant Flow|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
857840|NCT01211106|P1|Participant Flow|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
857841|NCT01211106|O2|Outcome|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
857842|NCT01211106|O1|Outcome|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
857843|NCT01211106|O2|Outcome|Arm 2 Sequential Therapy|MET followed by Prolonged Exposure
857844|NCT01211106|O1|Outcome|Arm 1: Integrated Conditions|Motivational enhancement therapy combined with Prolonged Exposure therapy.
857845|NCT01211106|E2|Reported Event|Sequential Treatment|Motivational enhancement therapy is started for the first 4 weeks and only after addressing addiction is prolonged exposure therapy begun.
857846|NCT01211106|E1|Reported Event|Integrated Care|Prolonged exposure treatment is combined with Motivational Enhancement therapy from the beginning of treatment.
857847|NCT01210820|B3|Baseline|Total|Total of all reporting groups
857848|NCT01210820|B2|Baseline|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
857849|NCT01210820|B1|Baseline|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
857850|NCT01210820|P2|Participant Flow|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
857851|NCT01210820|P1|Participant Flow|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS™ Femtosecond Laser System : intrastromal arcuate cuts made with iFS™ femtosecond laser"
857852|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
857853|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
857854|NCT01210820|O2|Outcome|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
857855|NCT01210820|O1|Outcome|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
858193|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
857856|NCT01210820|E2|Reported Event|Post Cataract With Residual Astigmatism|"Subjects who have had cataract removal surgery but have residual astigmatism.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
857857|NCT01210820|E1|Reported Event|Natural Astigmatism|"Subjects with refractive astigmatism and no prior history of ophthalmic surgery. May include subjects with cataracts.~iFS Femtosecond Laser System : intrastromal arcuate cuts made with iFS femtosecond laser"
857858|NCT01210807|B3|Baseline|Total|Total of all reporting groups
857859|NCT01210807|B2|Baseline|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
857860|NCT01210807|B1|Baseline|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
857861|NCT01210807|P2|Participant Flow|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
857862|NCT01210807|P1|Participant Flow|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
857863|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
857864|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
857865|NCT01210807|O2|Outcome|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
857866|NCT01210807|O1|Outcome|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
857867|NCT01210807|E2|Reported Event|ZCB00 Monofocal Intraocular Lens|Subjects bilaterally implanted with the Model ZCB00 Monofocal Intraocular Lens
857868|NCT01210807|E1|Reported Event|ZMB00 Multifocal Intraocular Lens|Subjects bilaterally implanted with the Model ZMB00 Multifocal Intraocular Lens
857869|NCT01210716|B1|Baseline|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
857870|NCT01210716|P2|Participant Flow|AMICUS First, Then Spectra|Patients randomized to Test (AMICUS) procedure first. Second procedure performed was Control (Spectra).
857871|NCT01210716|P1|Participant Flow|Spectra First, Then AMICUS|Patients randomized to Control (Spectra) procedure first. Second procedure performed was Test (AMICUS).
857872|NCT01210716|O1|Outcome|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
857873|NCT01210716|O2|Outcome|Spectra (Control)|Each evaluable patient underwent one complete TPE procedure on the COBE Spectra separator.
857874|NCT01210716|O1|Outcome|AMICUS (Test)|Each evaluable patient underwent one complete TPE procedure on the AMICUS separator.
857875|NCT01210716|E1|Reported Event|Overall Study Population|Includes groups randomized to receive Spectra first and AMICUS first.
857894|NCT01210651|O2|Outcome|Attention Control Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
857876|NCT01210690|B1|Baseline|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857877|NCT01210690|P1|Participant Flow|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857878|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857879|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and is not influenced by the study protocol.
857880|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857881|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857882|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857909|NCT01210495|B2|Baseline|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
858194|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
857883|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857884|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857885|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857886|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857887|NCT01210690|O1|Outcome|Patients, 1 - 11 Months Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857888|NCT01210690|E1|Reported Event|Patients, 1 - 11 Mths Old, Prescribed Keppra® Oral Solution|Epileptic patients who have been prescribed Keppra® (Levetiracetam) oral solution and who were between 1 and 11 months old. The patients were followed as per current clinical practices for their condition. The choice of medical treatment, including the concomitant use of other antiepileptic drugs, was made independently by the physician in the regular course of practice and was not influenced by the study protocol.
857889|NCT01210651|B3|Baseline|Total|Total of all reporting groups
857890|NCT01210651|B2|Baseline|Attention Control Education Group|Participants in this group met for 90-minute education seminars on yoga history twice a week for a total of 8 weeks.
857891|NCT01210651|B1|Baseline|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
857892|NCT01210651|P2|Participant Flow|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
857893|NCT01210651|P1|Participant Flow|Hatha Yoga Practice Group|Participants in this group met for 90-minute yoga practice sessions twice a weekly for a total of 8 weeks.
871053|NCT01174784|E1|Reported Event|Enrolled/Primary Cohort|
857895|NCT01210651|O1|Outcome|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
857896|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
857897|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
857898|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group met for 90-minute educational seminars on yoga history twice a week for a total of 8 weeks.
857899|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
857900|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
857901|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks.
857902|NCT01210651|O2|Outcome|Attention Control Education Group|Participants in this group attended 90-minute educational seminars on yoga history twice weekly for a total of 8 weeks.
857903|NCT01210651|O1|Outcome|Hatha Yoga Practice Group|Participants in this group practiced 90-minute sessions of hatha yoga exercises twice weekly for a total of 8 weeks.
857904|NCT01210651|E2|Reported Event|Attention Control Group|Participants in this group met for 90-minute education seminars on yoga history and philosophy twice a week for a total of 8 weeks.
857905|NCT01210651|E1|Reported Event|Yoga Practice Group|Participants in this group met for 90-minute sessions of hatha yoga practice twice a week for a total of 8 weeks. week for a total of 8 weeks.
857906|NCT01210495|B5|Baseline|Total|Total of all reporting groups
857907|NCT01210495|B4|Baseline|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857908|NCT01210495|B3|Baseline|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857910|NCT01210495|B1|Baseline|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857911|NCT01210495|P4|Participant Flow|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857912|NCT01210495|P3|Participant Flow|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857913|NCT01210495|P2|Participant Flow|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857914|NCT01210495|P1|Participant Flow|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg twice daily (BID).
857915|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857916|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857917|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857948|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857918|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857919|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857920|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857921|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857922|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857923|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857924|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857925|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857926|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857927|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857928|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857929|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857930|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857931|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857932|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857933|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857949|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857934|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857935|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857936|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857937|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857938|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857939|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857940|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
890597|NCT01119131|B4|Baseline|Total|Total of all reporting groups
857941|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857942|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857943|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857944|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857945|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857946|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857947|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
871054|NCT01174576|B1|Baseline|Group 1|
857950|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857951|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857952|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857953|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857954|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857955|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857956|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857957|NCT01210495|O2|Outcome|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non-randomized portion of this study to determine the recommended starting dose of axitinib for this population. The initial starting dose for this group was 2 mg BID.
857958|NCT01210495|O1|Outcome|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg BID.
857959|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857960|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
858195|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858196|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
857961|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857962|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857963|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857964|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857965|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857966|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857967|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
871214|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
857968|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857969|NCT01210495|O2|Outcome|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857970|NCT01210495|O1|Outcome|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857971|NCT01210495|E4|Reported Event|Placebo|Participants in this group received placebo + best supportive care. Treatment was administered in cycles of 4 weeks in duration. The starting dose of placebo for participants with Child Pugh Class A disease (score 5 or 6) was chosen as 5 mg BID. Participants with Child-Pugh Class B, score 7 received placebo that was determined from the non-randomized portion of the study until the recommended starting dose was determined, participants with Child-Pugh Class B, score 7, were not permitted to enter the randomized portion of the study.
857972|NCT01210495|E3|Reported Event|Axitinib|Participants in this group received axitinib + best supportive care. Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the randomized portion at a starting axitinib dose of 5 mg BID orally. Participants with Child-Pugh Class B disease (score 7) were to begin enrollment into the randomized portion of the study following determination of the recommended axitinib starting dose in the non-randomized portion. Study treatment was administered in cycles of 4 weeks in duration.
857973|NCT01210495|E2|Reported Event|Child-Pugh Class B|Participants with Child-Pugh Class B disease (score 7) at selected sites were initially enrolled only into the non randomized portion of this study to determine the recommended starting dose of axitinib for this population.
857974|NCT01210495|E1|Reported Event|Child-Pugh Class A|Participants with Child-Pugh Class A disease (score 5 or 6) were enrolled into the non-randomized portion at selected sites only at a starting axitinib dose of 5 mg twice daily (BID).
858197|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858198|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
890727|NCT01118780|B3|Baseline|Total|Total of all reporting groups
857975|NCT01210443|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857976|NCT01210443|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857977|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857978|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857979|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857980|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857981|NCT01210443|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857982|NCT01210443|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily. The intended treatment period was until sitaxentan was launched in Japan. Participants could receive additional PAH-specific drug treatment (beraprost or sildenafil) at the discretion of the investigator.
857983|NCT01210170|B1|Baseline|All Study Participants|• participant with asthma were enrolled in the study
857984|NCT01210170|P1|Participant Flow|All Study Participants|"• Inhalation of 400 µg mometasone DPI 30 min before inhalation of 180 µg albuterol~Mometasone furoate: • Inhalation of 400 µg mometasone or placebo DPI 30 min before inhalation of 180 µg albuterol~• Inhalation of 400 µg mometasone or placebo DPI 60 min before inhalation of 180 µg albuterol"
857985|NCT01210170|O4|Outcome|Mometasone Placebo and Albuterol Simultaneously|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
857986|NCT01210170|O3|Outcome|Mometasone and Albuterol Simultaneously|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol.
857987|NCT01210170|O2|Outcome|Mometasone Placebo 30 Minutes Before Albuterol|Inhalation of mometasone placebo 30 min before inhalation of 180 µg albuterol
857988|NCT01210170|O1|Outcome|Mometasone 30 Minutes Before Albuterol|• Inhalation of 400 µg mometasone 30 min before inhalation of 180 µg albuterol
857989|NCT01210170|O7|Outcome|All Participants Received Placebo -60 Min|placebo 60 minutes before inhalation of 180 mcg of albuterol
857990|NCT01210170|O6|Outcome|All Participants Received 400 mcg -60 Min|mometasone 400 mcg 60 minutes before inhalation of 180 mcg of albuterol
857991|NCT01210170|O5|Outcome|All Participants Received 200 mcg Mometasone-30 Min|mometasone 200 mcg 30 minutes before inhalation of 180 mcg of albuterol
857992|NCT01210170|O4|Outcome|All Participants Received Placebo Simultaneously With Albutero|inhalation of mometasone placebo immediately before inhalation of 180 mcg albuterol.
857993|NCT01210170|O3|Outcome|All Participants Received 400 mcg Mometasone Simultaneous|inhalation of 400 mcg mometasone immediately before inhalation of 180 mcg albuterol
857994|NCT01210170|O2|Outcome|All Participants Received Placebo 30 Minutes Before Albuterol|mometasone placebo 30 minutes before albuterol 180 mcg inhalation
857995|NCT01210170|O1|Outcome|All Participants Received 400 mcg Mometasone-30 Min|mometasone 400 mcg 30 minutes before albuterol 180 mcg inhalation
857996|NCT01210170|E1|Reported Event|All Study Participants|Simultaneous inhalation of 400 µg mometasone DPI and 180 µg albuterol
857997|NCT01210144|B3|Baseline|Total|Total of all reporting groups
857998|NCT01210144|B2|Baseline|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
857999|NCT01210144|B1|Baseline|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858000|NCT01210144|P2|Participant Flow|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858001|NCT01210144|P1|Participant Flow|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) gonadotropin-releasing hormone (GnRH) agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858002|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858003|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858004|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858005|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858071|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
858006|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858007|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858008|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858009|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858199|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858200|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858010|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858011|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858012|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858013|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858014|NCT01210144|O2|Outcome|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858028|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
858072|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
858015|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858016|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
858017|NCT01210144|O1|Outcome|Gonal-f® + Ovitrelle®|Participants received 150 IU per day of r-hFSH (Gonal-F®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm [for both long agonist and multi-dose antagonist protocol], and with E2>1 mcg/L [for long agonist protocol]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation, either 0.1 mg GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) in long agonist protocol or 0.25 mg GnRH antagonist daily was started from Day 6 of GONAL-f® stimulation treatment in multi-dose antagonist protocol, as per SmPC.
858082|NCT01209780|P3|Participant Flow|Control (3 to < 4 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination.The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- comparator TIV.
900910|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
858018|NCT01210144|E2|Reported Event|Gonal-f® + Ovitrelle® (Multi-dose Antagonist Protocol)|Participants received 150 IU per day of r-hFSH (Gonal-f®) sc starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 mcg r-hCG alfa (Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles >16 mm). To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily was started from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
858019|NCT01210144|E1|Reported Event|Gonal-f® + Ovitrelle® (Long Agonist Protocol)|Participants received 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH, Gonal-f®) subcutaneously (sc) starting from Day 2 of menstrual cycle until follicles were recruited and developed. Ovulation triggering was performed with a single dose of 250 microgram (mcg) recombinant human chorionic gonadotropin alfa (r-hCG alfa, Ovitrelle®) sc, as soon as follicles satisfied the criteria for follicular development (at least 3 follicles greater than [>] 16 millimeter [mm], and with estradiol [E2] >1 microgram per liter [mcg/L]). To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily was started after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
858020|NCT01210118|B3|Baseline|Total|Total of all reporting groups
858021|NCT01210118|B2|Baseline|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
858022|NCT01210118|B1|Baseline|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
858023|NCT01210118|P2|Participant Flow|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
858024|NCT01210118|P1|Participant Flow|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
858025|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
858026|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which included: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
858027|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
858070|NCT01209949|P1|Participant Flow|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
858029|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
858030|NCT01210118|O1|Outcome|High Intensity Intervention|Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the
858031|NCT01210118|O2|Outcome|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
858032|NCT01210118|O1|Outcome|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
858033|NCT01210118|E2|Reported Event|Low Intensity Intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
858083|NCT01209780|P2|Participant Flow|Control (4-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of US licensed control vaccine- TIVf.
900911|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
858034|NCT01210118|E1|Reported Event|High Intensity Intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
858035|NCT01210079|B3|Baseline|Total|Total of all reporting groups
858036|NCT01210079|B2|Baseline|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
858037|NCT01210079|B1|Baseline|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
858038|NCT01210079|P2|Participant Flow|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
858039|NCT01210079|P1|Participant Flow|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
858040|NCT01210079|O2|Outcome|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
858041|NCT01210079|O1|Outcome|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
858042|NCT01210079|E2|Reported Event|Placebo|Matched placebo group underwent identical 'titration' as intervention group.
858043|NCT01210079|E1|Reported Event|Gabapentin|Gabapentin titrated to 2400 mg daily PO for 5 weeks
858044|NCT01210001|B4|Baseline|Total|Total of all reporting groups
858045|NCT01210001|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858046|NCT01210001|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858047|NCT01210001|B1|Baseline|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858048|NCT01210001|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858049|NCT01210001|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858050|NCT01210001|P1|Participant Flow|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858051|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858052|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858053|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858054|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858055|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858056|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858057|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858058|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858059|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858060|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858061|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858062|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858063|NCT01210001|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858064|NCT01210001|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858065|NCT01210001|O1|Outcome|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858066|NCT01210001|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks
858067|NCT01210001|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks
858068|NCT01210001|E1|Reported Event|Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks
858069|NCT01209949|B1|Baseline|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
858073|NCT01209949|O1|Outcome|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
858074|NCT01209949|E1|Reported Event|Adapalene 0.1% and Benzoyl Peroxide 2.5% Gel|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel - apply topically to the face once daily in the evening for 12 weeks
858075|NCT01209780|B5|Baseline|Total|Total of all reporting groups
858076|NCT01209780|B4|Baseline|Control (9-17 Years)|All subjects received one dose of control TIV (eTIV_f).
858077|NCT01209780|B3|Baseline|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
858078|NCT01209780|B2|Baseline|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of vaccine.
858079|NCT01209780|B1|Baseline|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858080|NCT01209780|P5|Participant Flow|Control (9-17 Years)|All subjects in this group were non-naive and received one dose of US licensed control vaccine TIVf.
858081|NCT01209780|P4|Participant Flow|TIV (9-17 Years)|All subjects in this group were non-naive and received one dose of investigational TIV.
858187|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858188|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858084|NCT01209780|P1|Participant Flow|TIV (3-8 Years Old)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858085|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine (TIVf).
858086|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
858087|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
858088|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858089|NCT01209780|O4|Outcome|Control (9-17 Years)|All subjects received one dose of control vaccine(TIVf).
858090|NCT01209780|O3|Outcome|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
858091|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
858092|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858093|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
858094|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
858095|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to <4 years)] consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of control vaccine. Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received two doses of comparator TIV.
858096|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive subjects (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) who received two doses of investigational TIV.
858097|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
858119|NCT01209702|B1|Baseline|Combined Placebo|Participants in Part 1 and Part 2 who received intravenous infusions of placebo once every 4 weeks.
858416|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
858098|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858099|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
858100|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858101|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
858102|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858103|NCT01209780|O2|Outcome|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
858189|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858104|NCT01209780|O1|Outcome|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858105|NCT01209780|E4|Reported Event|Control (9-17 Years)|All subjects received one dose of control vaccine (TIV_f).
858106|NCT01209780|E3|Reported Event|TIV (9-17 Years)|All subjects received one dose of investigational TIV.
858107|NCT01209780|E2|Reported Event|Control (3-8 Years)|The group [control (4-8 years) + control (3 to<4 years)] consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). Subjects (4-<9 years) received TIVf and subjects (3-<4 years) received comparator TIV. The non-naive subjects received one dose and naive subjects received two doses of control vaccine.
858108|NCT01209780|E1|Reported Event|TIV (3-8 Years)|The group consisted of naive (who have never received influenza vaccination or had received only one influenza vaccine dose in the same season) and non-naive subjects (who had a record of previous influenza vaccination). The non-naive subjects received one dose and naive subjects received two doses of investigational TIV.
858109|NCT01209767|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
858110|NCT01209767|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the side of the body within each subject to receive either cryolipolysis or subcision.~cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite~Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together."
858111|NCT01209767|O3|Outcome|Control|Area that received no treatment
858112|NCT01209767|O2|Outcome|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
858113|NCT01209767|O1|Outcome|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator and then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
858114|NCT01209767|E3|Reported Event|Control|Nothing was done to the area.
858115|NCT01209767|E2|Reported Event|Subcision|Subcision : Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle was moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
858116|NCT01209767|E1|Reported Event|Cryolipolysis|cryolipolysis : During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
858117|NCT01209702|B3|Baseline|Total|Total of all reporting groups
858118|NCT01209702|B2|Baseline|Combined Tocilizumab|Participants randomized in Part 1 and Part 2 to receive intravenous infusions of 4 mg/kg (in Part 2 only) or 8 mg/kg tocilizumab once every 4 weeks.
858120|NCT01209702|P4|Participant Flow|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858121|NCT01209702|P3|Participant Flow|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858122|NCT01209702|P2|Participant Flow|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858123|NCT01209702|P1|Participant Flow|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858124|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858125|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858190|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858191|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
900912|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
858126|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858127|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858128|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858129|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858130|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
858131|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
858132|NCT01209702|O1|Outcome|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2, including participants randomized to placebo who switched or escaped to tocilizumab treatment.
858133|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858134|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858135|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858136|NCT01209702|O1|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858137|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
859766|NCT01203072|B1|Baseline|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
858138|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858139|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858140|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858141|NCT01209702|O1|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858192|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858142|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858143|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858144|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858145|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858146|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858147|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858148|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858149|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858150|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858151|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858152|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858153|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858417|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858154|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858155|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858156|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858157|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858158|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858159|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858160|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858161|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858162|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858163|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858164|NCT01209702|O4|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks until Week 24. Participants who did not attain an ASAS20 response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858165|NCT01209702|O3|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 24. Participants who did not attain an ASsessment in Ankylosing Spondylitis-20 (ASAS20) response at Week 16 were eligible to receive open-label escape therapy consisting of 8 mg/kg tocilizumab. After Week 24, participants were to receive open-label treatment with 8 mg/kg tocilizumab every 4 weeks until Week 104. At the completion of Week 104, all Part 2 participants were to receive tocilizumab 8 mg/kg in the common open-label extension phase.
858166|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858167|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858168|NCT01209702|O2|Outcome|Part 2: Tocilizumab|Participants received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks.
858169|NCT01209702|O1|Outcome|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks.
858170|NCT01209702|O2|Outcome|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12.
858171|NCT01209702|O1|Outcome|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12.
858172|NCT01209702|E4|Reported Event|All Tocilizumab|Participants who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks in either Part 1 or Part 2. This group includes participants randomized to placebo who switched or escaped to tocilizumab treatment for whom adverse events are reported after the start of treatment with tocilizumab.
858173|NCT01209702|E3|Reported Event|Part 2: Placebo|Participants received intravenous infusions of placebo once every 4 weeks. AEs reported only until participants escaped or switched to tocilizumab.
858174|NCT01209702|E2|Reported Event|Part 1: Tocilizumab|Participants received intravenous infusions of 8 mg/kg tocilizumab once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858175|NCT01209702|E1|Reported Event|Part 1: Placebo|Participants received intravenous infusions of placebo once every 4 weeks until Week 12. Following the Week 12 visit, participants were to receive open-label 8 mg/kg tocilizumab through Week 208 in the common open-label extension phase.
858176|NCT01209689|B3|Baseline|Total|Total of all reporting groups
858177|NCT01209689|B2|Baseline|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
858178|NCT01209689|B1|Baseline|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
858179|NCT01209689|P2|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
858180|NCT01209689|P1|Participant Flow|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
858181|NCT01209689|O2|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
858182|NCT01209689|O1|Outcome|Tocilizumab 4 or 8 mg/kg|Patients received tocilizumab 4 or 8 mg/kg intravenously every 4 weeks for 24 weeks.
858183|NCT01209689|E2|Reported Event|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks for 24 weeks.
858184|NCT01209689|E1|Reported Event|Tocilizumab|Patients randomized to tocilizumab who received intravenous infusions of 4 mg/kg or 8 mg/kg tocilizumab once every 4 weeks for 24 weeks and patients randomized to placebo who switched or escaped to tocilizumab treatment.
858185|NCT01209624|B1|Baseline|Xalatan®|Once daily as 1 drop (topical application) in the evening
858186|NCT01209624|P1|Participant Flow|Xalatan®|Once daily as 1 drop (topical application) in the evening
858201|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858202|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858203|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858204|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858205|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858206|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858207|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858208|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858209|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858210|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858211|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858212|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858213|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858214|NCT01209624|O1|Outcome|Xalatan®|Once daily as 1 drop (topical application) in the evening
858215|NCT01209624|E1|Reported Event|Xalatan®|Once daily as 1 drop (topical application) in the evening
858216|NCT01209520|B1|Baseline|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
858217|NCT01209520|P1|Participant Flow|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
858218|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
858219|NCT01209520|O1|Outcome|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
858220|NCT01209520|E1|Reported Event|Adjuvant Chemotherapy + Vidaza|"Cisplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Carboplatin: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Paclitaxel: Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.~Vidaza: Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles"
858221|NCT01209286|B4|Baseline|Total|Total of all reporting groups
858222|NCT01209286|B3|Baseline|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858223|NCT01209286|B2|Baseline|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
900913|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
858224|NCT01209286|B1|Baseline|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858225|NCT01209286|P3|Participant Flow|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858226|NCT01209286|P2|Participant Flow|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858227|NCT01209286|P1|Participant Flow|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858228|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
858229|NCT01209286|O1|Outcome|Blinatumomab|All participants who received blinatumomab.
858230|NCT01209286|O3|Outcome|Blinatumomab 30 μg|Participants receiving blinatumomab 30 μg/m²/day.
858231|NCT01209286|O2|Outcome|Blinatumomab 15 μg|Participants receiving blinatumomab 15 μg/m²/day.
858232|NCT01209286|O1|Outcome|Blinatumomab 5 μg|Participants receiving blinatumomab 5 μg/m²/day.
858233|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858234|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858235|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858236|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858237|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858261|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
871215|NCT01174446|O5|Outcome|On-Demand: End of Study|
858238|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858239|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858240|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858241|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858242|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858243|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858244|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858245|NCT01209286|O4|Outcome|Blinatumimab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858246|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858247|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858248|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858249|NCT01209286|O4|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858250|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858251|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858252|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858253|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858254|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858255|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858256|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858257|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858258|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858259|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858260|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858418|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858262|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858263|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858264|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858265|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858266|NCT01209286|O3|Outcome|ABlinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858267|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858268|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858269|NCT01209286|O4|Outcome|Blinatumomab Overall|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858270|NCT01209286|O3|Outcome|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858271|NCT01209286|O2|Outcome|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858272|NCT01209286|O1|Outcome|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858273|NCT01209286|E4|Reported Event|Blinatumomab Overall|All participants who received blinatumomab by continuous intravenous infusion during the core study.
858274|NCT01209286|E3|Reported Event|Blinatumomab 5/15/30 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, a dose of 15 μg/m²/day in the subsequent 7 days, followed by 30 μg/m²/day starting from Week 3 of treatment.
858275|NCT01209286|E2|Reported Event|Blinatumomab 5/15 μg|Participants received blinatumomab by continuous intravenous infusion over 4 weeks followed by a treatment-free interval of 2 weeks for up to 5 consecutive cycles. The initial dose was 5 μg/m²/day for the first seven days of treatment, followed by 15 μg/m²/day starting from Week 2 of treatment.
858276|NCT01209286|E1|Reported Event|Blinatumomab 15 μg|Participants received blinatumomab 15 μg/m²/day as a continuous intravenous infusion at a constant flow rate over 4 weeks followed by a 2-week treatment-free interval for up to 5 consecutive cycles.
858277|NCT01209260|B3|Baseline|Total|Total of all reporting groups
858278|NCT01209260|B2|Baseline|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858279|NCT01209260|B1|Baseline|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858280|NCT01209260|P2|Participant Flow|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858281|NCT01209260|P1|Participant Flow|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858282|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
858283|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
858284|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle
858285|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle
858286|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858287|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858288|NCT01209260|O2|Outcome|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858330|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
858289|NCT01209260|O1|Outcome|Radiofrequency Energy Needle|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858290|NCT01209260|E2|Reported Event|Mechanical Needle|Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858291|NCT01209260|E1|Reported Event|Radiofrequency Energy Needle (RF)|Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.
858292|NCT01209195|B3|Baseline|Total|Total of all reporting groups
858293|NCT01209195|B2|Baseline|MM-121 + Paclitaxel: Expansion Cohort|MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
858294|NCT01209195|B1|Baseline|MM-121 + Paclitaxel: Dose Escalation|"MM-121 plus Paclitaxel: Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Intermediate doses between cohorts 1 and 2 may also be considered."
858295|NCT01209195|P6|Participant Flow|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
858296|NCT01209195|P5|Participant Flow|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
858297|NCT01209195|P4|Participant Flow|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
858298|NCT01209195|P3|Participant Flow|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858299|NCT01209195|P2|Participant Flow|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858300|NCT01209195|P1|Participant Flow|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
858301|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
858302|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
858303|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
858304|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858305|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858306|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
858343|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858307|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.~Paclitaxel: 80 mg/m2"
858308|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
858309|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
858310|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
858311|NCT01209195|O4|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg + Rest Week|"MM-121: 40 mg/kg loading dose followed by seven 20mg/kg weekly doses and a rest week. This administration schedule spans two cycles and repeats for each subsequent 2-cycle unit.~Paclitaxel: 80 mg/m2"
858312|NCT01209195|O3|Outcome|MM-121 + Paclitaxel: 40 mg/kg Q2W|MM-121: 40 mg/kg Q2W Paclitaxel: 80 mg/m2
858313|NCT01209195|O2|Outcome|MM-121 + Paclitaxel: 40/20 mg/kg|MM-121: 40 mg/kg loading dose followed by 20 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
858314|NCT01209195|O1|Outcome|MM-121 + Paclitaxel: 20/12 mg/kg|MM-121: 20 mg/kg loading dose followed by 12 mg/kg weekly maintenance dose Paclitaxel: 80 mg/m2
858315|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
858316|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
858317|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
858318|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858319|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858320|NCT01209195|O1|Outcome|Part 1: Dose Escalation: Cohort 1|MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV
858321|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
858322|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
858323|NCT01209195|O2|Outcome|Part 2: Expansion Cohorts|Additional exploratory doses of MM-121 and paclitaxel
858324|NCT01209195|O1|Outcome|Part 1: Dose Escalation|Escalating doses of MM-121 and paclitaxel
858325|NCT01209195|O6|Outcome|Part 2: Cohort 4|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest~Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
858326|NCT01209195|O5|Outcome|Part 2: Cohort 3|"MM-121 40mg/kg IV QOW~Paclitaxel: 80 mg/m2 weekly IV"
858327|NCT01209195|O4|Outcome|Part 2: Expansion Cohort 2|"MM-121 20 mg/kg IV loading dose followed by 12 mg/kg IV QW maintenance dose~Paclitaxel: 80 mg/m2 weekly IV"
858328|NCT01209195|O3|Outcome|Part 2: Expansion Cohort 1|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858329|NCT01209195|O2|Outcome|Part 1: Dose Escalation: Cohort 2|"MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV~Paclitaxel - 80mg/m2 weekly IV"
858331|NCT01209195|E2|Reported Event|MM-121 + Paclitaxel: Expansion Cohort|"Cohort 1:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 20 mg/kg IV loading dose x followed by 12 mg/kg IV QW maintenance dose Paclitaxel: 80 mg/m2 weekly IV~Cohort 3:~MM-121 40mg/kg IV QOW Paclitaxel: 80 mg/m2 weekly IV~Cohort 4:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV for 3 weeks, followed by one week of rest Paclitaxel - 80mg/m2 weekly IV for 3 weeks, followed by one week of rest"
858332|NCT01209195|E1|Reported Event|MM-121 + Paclitaxel: Dose Escalation|"Cohort 1:~MM-121 - 20 mg/kg loading dose followed by 12 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV~Cohort 2:~MM-121 - 40 mg/kg loading dose followed by 20 mg/kg weekly IV Paclitaxel - 80mg/m2 weekly IV"
858333|NCT01208402|B3|Baseline|Total|Total of all reporting groups
858334|NCT01208402|B2|Baseline|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858335|NCT01208402|B1|Baseline|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858336|NCT01208402|P2|Participant Flow|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858337|NCT01208402|P1|Participant Flow|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858338|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858339|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858340|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858341|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858342|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858344|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858345|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858346|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858347|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858348|NCT01208402|O2|Outcome|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858349|NCT01208402|O1|Outcome|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858350|NCT01208402|E2|Reported Event|Esmolol|Replace patient’s routine oral long-acting beta blocker on day of surgery with a bolus of 500 mcg/kg at start of surgery, followed by a 4 minute infusion at 50 mcg/kg/min, titrating up to a maximum of 300mcg/kg/min to maintain heart rate and SBP within specified thresholds during the length of surgery and continuing through 12 hours post-operatively.
858351|NCT01208402|E1|Reported Event|Long-Acting Beta Blocker|Administer patient’s routine oral long acting beta blocker on day of surgery (standard of care).
858352|NCT01208337|B1|Baseline|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858353|NCT01208337|P1|Participant Flow|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858354|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858410|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
859855|NCT01202747|E1|Reported Event|LipiFlow Treatment|Treatment with LipiFlow device
858355|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858356|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858357|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858358|NCT01208337|O1|Outcome|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858359|NCT01208337|E1|Reported Event|Alemtuzumab Induction|"Intestine transplant recipients who receive induction with alemtuzumab prior to transplantation.~Alemtuzumab: Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone"
858360|NCT01209143|B3|Baseline|Total|Total of all reporting groups
858361|NCT01209143|B2|Baseline|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
858362|NCT01209143|B1|Baseline|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
858380|NCT01208961|E1|Reported Event|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
858381|NCT01208233|B7|Baseline|Total|Total of all reporting groups
860458|NCT01200524|P1|Participant Flow|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
858363|NCT01209143|P2|Participant Flow|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
858364|NCT01209143|P1|Participant Flow|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
858365|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
858366|NCT01209143|O1|Outcome|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
858367|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
858368|NCT01209143|O1|Outcome|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
858369|NCT01209143|E2|Reported Event|Vismodegib + Oral Contraceptive|"Participants received the oral contraceptive norethindrone 1 mg/ethinyl estradiol 35 µg (Ortho-Novum 1/35®) orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Norethindrone/ethinyl estradiol: Norethindrone/ethinyl estradiol was supplied in tablets."
858411|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858412|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858413|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858370|NCT01209143|E1|Reported Event|Vismodegib + Rosiglitazone|"Participants received rosiglitazone 4 mg orally on Days 1 and 8 of the study. Participants also received vismodegib 150 mg orally once a day beginning on Day 2 until one of the following occurred; disease progression, intolerable toxicity, most probably attributable to vismodegib, or patient withdrawal of consent.~Vismodegib: Vismodegib was supplied in hard gelatin capsules.~Rosiglitazone: Rosiglitazone was supplied in tablets."
858371|NCT01208961|B1|Baseline|All Subjects|All subjects received both Epanova (E) and Lovaza (L), and both under fasted and fed conditions. Subjects were randomized 1:1 to one of the following treatment period sequences: ELEL or LELE.
858372|NCT01208961|P2|Participant Flow|Lovaza-Epanova-Lovaza-Epanova|Lovaza (4 g) and Epanova (4 g) : Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Epanova (omefas),4x1g capsules, taken with high-fat meals
858373|NCT01208961|P1|Participant Flow|Epanova-Lovaza-Epanova-Lovaza|Epanova (4 g) and Lovaza (4 g) : Single dose of Epanova (omefas; corresponds to omega-3 carboxylic acids), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
858374|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
858375|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
858376|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
858377|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
858378|NCT01208961|O2|Outcome|Lovaza (Low-Fat Period)|Single dose of Lovaza (omega-3-acid ethyl esters), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
858379|NCT01208961|O1|Outcome|Epanova (Low-Fat Period)|Single dose of Epanova (omefas), 4*1g capsules, taken after fasting 12 hours with no breakfast, followed with no-fat lunch and low-fat dinner
858382|NCT01208233|B6|Baseline|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858383|NCT01208233|B5|Baseline|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858384|NCT01208233|B4|Baseline|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858385|NCT01208233|B3|Baseline|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858386|NCT01208233|B2|Baseline|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858387|NCT01208233|B1|Baseline|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858388|NCT01208233|P6|Participant Flow|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858389|NCT01208233|P5|Participant Flow|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858390|NCT01208233|P4|Participant Flow|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858391|NCT01208233|P3|Participant Flow|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858392|NCT01208233|P2|Participant Flow|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858393|NCT01208233|P1|Participant Flow|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858394|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858395|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858396|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
858397|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858398|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
858399|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858400|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858401|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858402|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
858403|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858404|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
858405|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858406|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858407|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858408|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
858409|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
859856|NCT01202656|B3|Baseline|Total|Total of all reporting groups
858419|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858420|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-03049423 6 mg once daily for 90 days.
858421|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858422|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-03049423 3 mg once daily for 90 days.
858423|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858424|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858425|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858426|NCT01208233|O3|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858427|NCT01208233|O2|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858428|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858429|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858430|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858431|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858432|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858433|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858434|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858435|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858436|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858437|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858438|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858439|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858440|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858441|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858442|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858443|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
861346|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
858444|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858445|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858446|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858447|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858448|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858449|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858450|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858451|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858452|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858453|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858454|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858455|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858456|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858457|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858458|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858459|NCT01208233|O2|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858460|NCT01208233|O1|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858461|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858462|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858463|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858464|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858465|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858466|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858467|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858468|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858469|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858470|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858471|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
871517|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
858472|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858473|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858474|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858475|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858476|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858477|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858478|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858479|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858480|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858481|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858482|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858483|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858484|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858485|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858486|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858487|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858488|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858489|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858490|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858491|NCT01208233|O6|Outcome|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858492|NCT01208233|O5|Outcome|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858493|NCT01208233|O4|Outcome|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858494|NCT01208233|O3|Outcome|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858495|NCT01208233|O2|Outcome|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858496|NCT01208233|O1|Outcome|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858497|NCT01208233|E6|Reported Event|Cohort 3: Placebo|Participants received placebo matched to PF-0304942 6 mg once daily for 90 days.
858498|NCT01208233|E5|Reported Event|Cohort 3: PF-03049423 6 mg|Participants received PF-03049423 6 mg once daily for 90 days.
858499|NCT01208233|E4|Reported Event|Cohort 2: Placebo|Participants received placebo matched to PF-0304942 3 mg once daily for 90 days.
858500|NCT01208233|E3|Reported Event|Cohort 2: PF-03049423 3 mg|Participants received PF-03049423 3 mg once daily for 90 days.
858501|NCT01208233|E2|Reported Event|Cohort 1: Placebo|Participants received placebo matched to PF-03049423 1 mg once daily for 90 days.
858502|NCT01208233|E1|Reported Event|Cohort 1: PF-03049423 1 mg|Participants received PF-03049423 1 mg once daily for 90 days.
858503|NCT01208220|B3|Baseline|Total|Total of all reporting groups
858504|NCT01208220|B2|Baseline|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
858505|NCT01208220|B1|Baseline|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
858506|NCT01208220|P2|Participant Flow|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
858507|NCT01208220|P1|Participant Flow|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
858508|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
858509|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
858510|NCT01208220|O2|Outcome|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
858511|NCT01208220|O1|Outcome|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
858512|NCT01208220|E2|Reported Event|Santyl Ointment and NPWT|"Enzymatic debriding ointment used in conjunction with negative pressure wound therapy~Collagenase Santyl : Topical enzyme applied to wound tissue"
858513|NCT01208220|E1|Reported Event|Negative Pressure Wound Therapy|"NPWT alone for treatment of pressure ulcer~NPWT - VAC : Vacuum Assisted Closure at 125 mm of negative pressure continuous, dressing changed three times weekly"
858514|NCT01208207|B4|Baseline|Total|Total of all reporting groups
858515|NCT01208207|B3|Baseline|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily
858516|NCT01208207|B2|Baseline|Etoricoxib 90 mg|Etoricoxib 90 mg once daily
858517|NCT01208207|B1|Baseline|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily
858518|NCT01208207|P7|Participant Flow|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
858519|NCT01208207|P6|Participant Flow|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
858520|NCT01208207|P5|Participant Flow|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
858521|NCT01208207|P4|Participant Flow|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
858522|NCT01208207|P3|Participant Flow|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
858523|NCT01208207|P2|Participant Flow|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
858524|NCT01208207|P1|Participant Flow|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
858525|NCT01208207|O7|Outcome|Naproxen 1000 mg (Part II)|A continuation of the naproxen 500 mg oral tablet twice daily for 20 weeks (Part II)
858526|NCT01208207|O6|Outcome|Etoricoxib 90 mg / 90 mg (Part II)|A continuation of the etoricoxib 90 mg oral tablet once daily for 20 weeks (Part II)
858527|NCT01208207|O5|Outcome|Etoricoxib 60 mg / 90 mg (Part II)|An increase of etoricoxib to 90 mg for 20 weeks (Part II)
858528|NCT01208207|O4|Outcome|Etoricoxib 60 mg / 60 mg (Part II)|A continuation of the etoricoxib 60 mg oral tablet once daily for 20 weeks (Part II)
858529|NCT01208207|O3|Outcome|Naproxen 1000 mg (Part I)|Naproxen 500 mg oral tablet twice daily for 6 weeks
858530|NCT01208207|O2|Outcome|Etoricoxib 90 mg (Part I)|Etoricoxib 90 mg oral tablet once daily for 6 weeks
858531|NCT01208207|O1|Outcome|Etoricoxib 60 mg (Part I)|Etoricoxib 60 mg oral tablet once daily for 6 weeks
858532|NCT01208207|O2|Outcome|Etoricoxib 60 mg / 60 mg|Etoricoxib 60 mg in Part I and Etoricoxib 60 mg in Part II
858533|NCT01208207|O1|Outcome|Etoricoxib 60 mg/ 90 mg|Etoricoxib 60 mg in Part I and Etoricoxib 90 mg in Part II
858534|NCT01208207|O2|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
858535|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
858536|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
858537|NCT01208207|O1|Outcome|Etoricoxib 60 mg|Etoricoxib 60 mg oral tablet once daily for 6 weeks
858538|NCT01208207|O2|Outcome|Naproxen 1000 mg|Naproxen 500 mg oral tablet twice daily for 6 weeks
858539|NCT01208207|O1|Outcome|Etoricoxib 90 mg|Etoricoxib 90 mg oral tablet once daily for 6 weeks
858540|NCT01208207|E7|Reported Event|Naproxen 1000 mg|Participants who received at least one dose of Naproxen 1000 mg in Part I, but no drug in Part II.
858541|NCT01208207|E6|Reported Event|Etoricoxib 90 mg|Participants who received at least one dose of Etoricoxib 90 mg in Part I, but no drug in Part II.
858542|NCT01208207|E5|Reported Event|Etoricoxib 60 mg|Participants who received at least one dose of Etoricoxib 60 mg in Part I, but no drug in Part II.
858543|NCT01208207|E4|Reported Event|Naproxen 1000 mg / Naproxen 1000 mg|Participants who received Naproxen 1000 mg in Part I and at least one dose of Naproxen 1000 mg in Part II.
858691|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
858544|NCT01208207|E3|Reported Event|Etoricoxib 90 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 90 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
858545|NCT01208207|E2|Reported Event|Etoricoxib 60 mg / Etoricoxib 90 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 90 mg in Part II.
858546|NCT01208207|E1|Reported Event|Etoricoxib 60 mg / Etoricoxib 60 mg|Participants who received Etoricoxib 60 mg in Part I and at least one dose of Etoricoxib 60 mg in Part II.
858547|NCT01208181|B4|Baseline|Total|Total of all reporting groups
858548|NCT01208181|B3|Baseline|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
858549|NCT01208181|B2|Baseline|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858550|NCT01208181|B1|Baseline|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858551|NCT01208181|P5|Participant Flow|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
858552|NCT01208181|P4|Participant Flow|Etoricoxib 60/Etoricoxib 90mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
858553|NCT01208181|P3|Participant Flow|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence received etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
858554|NCT01208181|P2|Participant Flow|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858555|NCT01208181|P1|Participant Flow|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858556|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
858557|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
858558|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
858559|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858560|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858561|NCT01208181|O5|Outcome|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
858562|NCT01208181|O4|Outcome|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
858790|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858563|NCT01208181|O3|Outcome|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
858564|NCT01208181|O2|Outcome|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858565|NCT01208181|O1|Outcome|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858566|NCT01208181|O2|Outcome|Etoricoxib 60 mg/Etoricoxib 90 mg|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and etoricoxib 90 mg tablets Part 2 of the study.
858567|NCT01208181|O1|Outcome|Etoricoxib 60 mg/Etoricoxib 60 mg|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib 60 mg tablets administered orally once daily in Part 1 and Part 2 of the study.
858568|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858569|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858570|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858571|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858572|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
858573|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858574|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858575|NCT01208181|O3|Outcome|Placebo|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
858576|NCT01208181|O2|Outcome|Etoricoxib 90 mg|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858577|NCT01208181|O1|Outcome|Etoricoxib 60 mg|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858578|NCT01208181|E5|Reported Event|Placebo - Part 1|The placebo treatment group received placebo to etoricoxib tablets administered orally once daily in Part 1 of the study.
858647|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858579|NCT01208181|E4|Reported Event|Etoricoxib 60mg/Etoricoxib 90mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 90 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study and etoricoxib tablets 90 mg administered orally once daily in Part 2 of the study.
858580|NCT01208181|E3|Reported Event|Etoricoxib 60mg/Etoricoxib 60mg - Part 1/2|The etoricoxib 60 mg/etoricoxib 60 mg treatment sequence will receive etoricoxib tablets 60 mg administered orally once daily in Part 1 and Part 2 of the study.
858581|NCT01208181|E2|Reported Event|Etoricoxib 90 mg - Part 1|The etoricoxib 90 mg treatment sequence received etoricoxib tablets 90 mg administered orally once daily in Part 1 of the study.
858582|NCT01208181|E1|Reported Event|Etoricoxib 60 mg - Part 1|The etoricoxib 60 mg treatment group received etoricoxib tablets 60 mg administered orally once daily in Part 1 of the study.
858583|NCT01207934|B4|Baseline|Total|Total of all reporting groups
858584|NCT01207934|B3|Baseline|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
858585|NCT01207934|B2|Baseline|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
858586|NCT01207934|B1|Baseline|Placebo|saline placebo for fourteen days
858587|NCT01207934|P3|Participant Flow|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
858588|NCT01207934|P2|Participant Flow|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
858589|NCT01207934|P1|Participant Flow|Placebo|saline placebo for fourteen days
858590|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
858591|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
858592|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
858593|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
858594|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
858595|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
858596|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
858597|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
858598|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
858599|NCT01207934|O3|Outcome|High Dose Leptin|80mg leptin daily for fourteen days
858600|NCT01207934|O2|Outcome|Low Dose Leptin|30mg leptin daily for fourteen days
858601|NCT01207934|O1|Outcome|Placebo|14 days on placebo (saline)
858602|NCT01207934|E3|Reported Event|High-dose Leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
858603|NCT01207934|E2|Reported Event|Low-dose Leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
858604|NCT01207934|E1|Reported Event|Placebo|saline placebo for fourteen days
858605|NCT01207765|B1|Baseline|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
858606|NCT01207765|P1|Participant Flow|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
858607|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
859904|NCT01202578|P1|Participant Flow|Tympanostomy Tube Placement Using the Tube Delivery System|
858608|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
858609|NCT01207765|O1|Outcome|Zevalin|90Y Zevalin: Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
858610|NCT01207765|E1|Reported Event|Zevalin|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging on study day +1. 90Y Zevalin will be administered seven to nine days after 111In Zevalin administration. The dose of 90Y Zevalin will be 0.4 mCi/kg, capped at a maximum dose of 32 mCi.
858611|NCT01207648|B1|Baseline|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858612|NCT01207648|P1|Participant Flow|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858613|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858614|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858648|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858615|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858616|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858617|NCT01207648|O1|Outcome|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858618|NCT01207648|E1|Reported Event|Retrospective Cohort|Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events were observed in this retrospective cohort study. In this study, medical records of participants evaluated between 1997 to 2009 were reviewed. The observation period started with the first medical record available till last medical record available on site or the end of the observation period (31 December 2009), whichever occurred first.
858619|NCT01207596|B1|Baseline|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858620|NCT01207596|P1|Participant Flow|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858621|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858622|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858623|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858624|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858625|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858626|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858627|NCT01207596|O1|Outcome|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858628|NCT01207596|E1|Reported Event|Hydromorphone|Received once-daily OROS hydromorphone ER, individually titrated, available in 8, 12, and 16-mg tablet strengths
858629|NCT01207583|B4|Baseline|Total|Total of all reporting groups
858630|NCT01207583|B3|Baseline|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
858631|NCT01207583|B2|Baseline|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
858632|NCT01207583|B1|Baseline|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of PCV7 vaccine as standard care as per the SmPC.
858633|NCT01207583|P3|Participant Flow|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received 2 doses (Dose 1 and Dose 2) of PCV7 vaccine as standard care as per the SmPC.
858634|NCT01207583|P2|Participant Flow|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received 3 doses (Dose 1, Dose 2 and Dose 3) of PCV7 vaccine as standard care as per the SmPC.
858635|NCT01207583|P1|Participant Flow|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received 4 doses (Dose 1, Dose 2, Dose 3 and Dose 4) of 7-valent pneumococcal conjugate vaccine (PCV7) as standard care as per the Summary of Product Characteristics (SmPC).
858636|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
858637|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858638|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858639|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858640|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858641|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858642|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccines as standard care as per the SmPC.
858643|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858644|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858645|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
858646|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858649|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858650|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858651|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858652|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858653|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858654|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
858655|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858656|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858657|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858658|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858659|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858660|NCT01207583|O3|Outcome|Catch-up Cohort (12-23 Months)|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858661|NCT01207583|O2|Outcome|Catch-up Cohort (7-11 Months)|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858662|NCT01207583|O1|Outcome|Primary Cohort (3-6 Months)|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858663|NCT01207583|E9|Reported Event|Dose 2 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858664|NCT01207583|E8|Reported Event|Dose 1 (Catch-up Cohort [12-23 Months])|Participants in the age group 12-23 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858665|NCT01207583|E7|Reported Event|Dose 3 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858666|NCT01207583|E6|Reported Event|Dose 2 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
858667|NCT01207583|E5|Reported Event|Dose 1 (Catch-up Cohort [7-11 Months])|Participants in the age group 7-11 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858668|NCT01207583|E4|Reported Event|Dose 4 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 4 of PCV7 vaccine as standard care as per the SmPC.
858669|NCT01207583|E3|Reported Event|Dose 3 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 3 of PCV7 vaccine as standard care as per the SmPC.
858670|NCT01207583|E2|Reported Event|Dose 2 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 2 of PCV7 vaccine as standard care as per the SmPC.
859905|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
858671|NCT01207583|E1|Reported Event|Dose 1 (Primary Cohort [3-6 Months])|Participants in the age group 3-6 months received Dose 1 of PCV7 vaccine as standard care as per the SmPC.
858672|NCT01207570|B3|Baseline|Total|Total of all reporting groups
858673|NCT01207570|B2|Baseline|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
858674|NCT01207570|B1|Baseline|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
858675|NCT01207570|P2|Participant Flow|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
858676|NCT01207570|P1|Participant Flow|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
858677|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
858678|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
858679|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
858680|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
858681|NCT01207570|O2|Outcome|Passive Stretching|A single session of passive stretching
858682|NCT01207570|O1|Outcome|Endermotherapy|A single session of endermotherapy treatment
858683|NCT01207570|O2|Outcome|Passive Stretching|A single passive stretching session
858684|NCT01207570|O1|Outcome|Endermotherapy|A single endermotherapy treatment session
858685|NCT01207570|E2|Reported Event|Passive Stretching|The subjects in this group will receive a single session of passive stretching of the gastrocnemius/soleus muscle for 5 minutes.
858686|NCT01207570|E1|Reported Event|Endermotherapy|The subjects in the experimental group will receive a single session (5 minutes) of endermotherapy) applied to the gastrocnemius/soleus muscle group in the more affected side. The treatment will b e carried out by a qualified physiotherapist.
858687|NCT01207492|B1|Baseline|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
858688|NCT01207492|P1|Participant Flow|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
858689|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
858690|NCT01207492|O1|Outcome|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
858692|NCT01207492|E1|Reported Event|Nilotinib|"Nilotinib 200 mg taken as 400 mg twice daily, continuously~nilotinib: Taken orally twice daily"
858693|NCT01207466|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
858694|NCT01207466|P2|Participant Flow|Nelfilcon A Comm'l / nelfilconA Invest'l|Nelfilcon A commercial toric contact lenses worn first, with nelfilcon A investigational toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
858695|NCT01207466|P1|Participant Flow|Nelfilcon A Invest'l / nelfilconA Comm'l|Nelfilcon A investigational toric contact lenses worn first, with nelfilcon A commercial toric contact lenses worn second. Each product worn bilaterally on a daily disposable basis for one week.
858696|NCT01207466|O2|Outcome|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
858697|NCT01207466|O1|Outcome|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
858698|NCT01207466|E2|Reported Event|Nelfilcon A Commercial|Commercially marketed, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
858699|NCT01207466|E1|Reported Event|Nelfilcon A Investigational|Investigational, soft contact lenses for astigmatism worn bilaterally on a daily disposable basis for one week.
858700|NCT01207453|B3|Baseline|Total|Total of all reporting groups
858701|NCT01207453|B2|Baseline|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
858702|NCT01207453|B1|Baseline|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
858703|NCT01207453|P2|Participant Flow|Placebo and Then Milnacipran|Participants first received 6 weeks of placebo. This was followed by a 3-week wash-out. After the wash-out period, participants then received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily).
858704|NCT01207453|P1|Participant Flow|Milnacipran and Then Placebo|Participants first received 6 weeks of milnacipran (titrated up to full dose of 50 mg twice daily). This was followed by a 3-week wash-out. Participants then received 6 weeks of placebo.
858705|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
858706|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
858707|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
858708|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
858709|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
858710|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
858711|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
858712|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
858713|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
858714|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
858715|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran: Participants who take Milnacipran twice a day orally dosage was titrated up to target dosage of 50 mg (12.5 mg, 25 mg and 50 mg)."
858716|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
858717|NCT01207453|O2|Outcome|Milnacipran|"Participants who received milnacipran in either the first or last 6 weeks of the study.~Milnacipran is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily."
858718|NCT01207453|O1|Outcome|Placebo|Participants who received placebo in either the first or last 6 weeks of the study.
858719|NCT01207453|E3|Reported Event|Washout Period|This 3-week period occurred after the first 6 weeks (when participants either received milnacipran or placebo). During the washout period, participants down titrated from the full dosage of milnacipran/placebo to nothing.
858720|NCT01207453|E2|Reported Event|Placebo|Participants received placebo tablets for 6 weeks. The tablets were identical in appearance to the milnacipran tablets.
858721|NCT01207453|E1|Reported Event|Milnacipran|Participants received milnacipran for 6 weeks. The dose was titrated according to the following schedule: 1) Days 1-3: milnacipran 12.5 mg twice daily, 2) Days 4-6: milnacipran 25 mg twice daily, 3) Days 7-42: milnacipran 50 mg twice daily. If participants could not tolerate the full dose, the dose was decreased to the highest tolerated dose.
858722|NCT01207427|B4|Baseline|Total|Total of all reporting groups
858723|NCT01207427|B3|Baseline|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
858724|NCT01207427|B2|Baseline|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858831|NCT01206738|E3|Reported Event|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
858725|NCT01207427|B1|Baseline|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1 mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858726|NCT01207427|P3|Participant Flow|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
858727|NCT01207427|P2|Participant Flow|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858728|NCT01207427|P1|Participant Flow|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-milligrams (mg) ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858729|NCT01207427|O3|Outcome|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
858730|NCT01207427|O2|Outcome|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858731|NCT01207427|O1|Outcome|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858732|NCT01207427|E3|Reported Event|Placebo|Each participant received 1 placebo capsule orally twice daily (BID) during the Run-in Placebo Period (1 week), the Double-blind Treatment Period (4 weeks), and the Run-out Placebo Period (1 week).
858733|NCT01207427|E2|Reported Event|ADL5945 0.25 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.25-mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858734|NCT01207427|E1|Reported Event|ADL5945 0.1 mg|During the Run-in Placebo Period, each participant received 1 placebo capsule orally BID for 1 week. Then during the Double-blind Treatment Period, each participant received one 0.1- mg ADL5945 capsule orally BID for 4 weeks. Then during the Run-out Placebo Period, each participant received 1 placebo capsule orally BID for 1 week.
858735|NCT01207414|B3|Baseline|Total|Total of all reporting groups
858736|NCT01207414|B2|Baseline|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858791|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858792|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858737|NCT01207414|B1|Baseline|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858738|NCT01207414|P2|Participant Flow|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858739|NCT01207414|P1|Participant Flow|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858740|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858741|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858742|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
859040|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
858743|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858744|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858745|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858746|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858747|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858748|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858749|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858750|NCT01207414|O2|Outcome|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858793|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858794|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858751|NCT01207414|O1|Outcome|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858752|NCT01207414|E2|Reported Event|Iloperidone Immediate Switch|"Participants taking risperidone, olanzapine or aripiprazole discontinued the drug immediately.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858753|NCT01207414|E1|Reported Event|Iloperidone Gradual Switch|"Participants taking risperidone, olanzapine or aripiprazole gradually decreased the dose they were taking: 50% of original dose on Day 1, 25% of original dose after the first week and the total discontinuation of the drug after the second week.~On Day 1 participants began taking iloperidone orally twice a day (bid) in the morning and in the evening beginning at a dose of 1 mg and increasing to 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg bid on consecutive days over a 7-day period to achieve a total dose of 12-24 mg/day for 12 weeks."
858754|NCT01207401|B3|Baseline|Total|Total of all reporting groups
858755|NCT01207401|B2|Baseline|No Paracervical Block|
858756|NCT01207401|B1|Baseline|Paracervical Block|
858757|NCT01207401|P2|Participant Flow|No Paracervical Block|IUD insertion with no lidocaine injection
858758|NCT01207401|P1|Participant Flow|Paracervical Block|IUD insertion after a 10 cc 1% Lidocaine administeration at 4 o'clock and 8 o'clock at the cervical-vaginal mucosa.
858759|NCT01207401|O2|Outcome|No Paracervical Block|
858760|NCT01207401|O1|Outcome|Paracervical Block|
858761|NCT01207401|E2|Reported Event|No Paracervical Block|
858762|NCT01207401|E1|Reported Event|Paracervical Block|
858763|NCT01207388|B1|Baseline|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858810|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
858764|NCT01207388|P1|Participant Flow|Blinatumomab|"Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.~Participants suitable for allogeneic hematopoietic stem cell transplant (HSCT) after treatment with at least 1 cycle of blinatumomab may have undergone allogeneic HSCT instead of receiving further cycles with blinatumomab."
858765|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
858766|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
858767|NCT01207388|O2|Outcome|Change From Baseline at End of Core Study|
858768|NCT01207388|O1|Outcome|Maximum Change From Baseline in Cycles 1 - 4|
858769|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858770|NCT01207388|O6|Outcome|Cycle 1 MRD Unknown|Participants with an unknown MRD level at the end of cycle 1.
858771|NCT01207388|O5|Outcome|Cycle 1 MRD 10^-1|Participants with an MRD level 10^-1 at the end of cycle 1.
858772|NCT01207388|O4|Outcome|Cycle 1 MRD 10^-2|Participants with an MRD level 10^-2 at the end of cycle 1.
858773|NCT01207388|O3|Outcome|Cycle 1 MRD 10^-3|Participants with an MRD level 10^-3 at the end of cycle 1.
858774|NCT01207388|O2|Outcome|Cycle 1 MRD 10^-4|Participants with an MRD level 10^-4 at the end of cycle 1.
858775|NCT01207388|O1|Outcome|Cycle 1 MRD 10^-5|Participants with an MRD level 10^-5 at the end of cycle 1.
858776|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858777|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858778|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858779|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858780|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858781|NCT01207388|O1|Outcome|Blinatumomab|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858782|NCT01207388|E1|Reported Event|Blinatumomab 15 µg/m2/d|Participants received blinatumomab as a continuous intravenous infusion at a constant flow rate of 15 μg/m²/day over 28 days followed by an infusion-free period of 14 days for up to 4 cycles of treatment.
858783|NCT01207219|B4|Baseline|Total|Total of all reporting groups
858784|NCT01207219|B3|Baseline|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858785|NCT01207219|B2|Baseline|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858786|NCT01207219|B1|Baseline|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858787|NCT01207219|P3|Participant Flow|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858788|NCT01207219|P2|Participant Flow|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858789|NCT01207219|P1|Participant Flow|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858795|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858796|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858797|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858798|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858799|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858800|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858801|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858802|NCT01207219|O3|Outcome|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858803|NCT01207219|O2|Outcome|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858804|NCT01207219|O1|Outcome|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858805|NCT01207219|E3|Reported Event|Waitlist Control Group|Patients in waitlist were treated as usual and acted as the control group.
858806|NCT01207219|E2|Reported Event|Aerobic Exercise|Included walking and cycling, three times per week for 12 weeks, each session lasted around one hour.
858807|NCT01207219|E1|Reported Event|Yoga Therapy|Hatha yoga, three sessions per week for 12 weeks, each session lasted around one hour.
858808|NCT01207102|B1|Baseline|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
858809|NCT01207102|P1|Participant Flow|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
858811|NCT01207102|O1|Outcome|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
858812|NCT01207102|E1|Reported Event|Abraxane, Carboplatin|"Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle~Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days~Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days"
858813|NCT01206777|B1|Baseline|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
858814|NCT01206777|P1|Participant Flow|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
858815|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
858816|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
858817|NCT01206777|O1|Outcome|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
858818|NCT01206777|E1|Reported Event|Rituximab|Rituximab: Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
858819|NCT01206738|B4|Baseline|Total|Total of all reporting groups
858820|NCT01206738|B3|Baseline|General Information|No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care)
858821|NCT01206738|B2|Baseline|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
858822|NCT01206738|B1|Baseline|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
858823|NCT01206738|P3|Participant Flow|General Information|"No information beyond the information that GPs already have from guidelines and other diverse sources (ie. usual care).~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
858851|NCT01206608|P1|Participant Flow|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858852|NCT01206608|O2|Outcome|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
858853|NCT01206608|O1|Outcome|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. A single dose of study drug was administration via local infiltration.
858824|NCT01206738|P2|Participant Flow|Alternative Intervention|"Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
858825|NCT01206738|P1|Participant Flow|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Note: for the Overall study, the best 25% of prescribers completing the email vs postal invitation sub study (which 270 individuals completed) were not eligible by definition (we only wanted to trial our interventions with doctors not prescribing according to best practice). Of the 270, only 201 were eligible. All were invited to participate, along with 313 other family doctors who had not taken part in the email vs. postal invitation study. Of the 514 (201 + 313) invited to the Overall study, 198 responded and these are the participants for the Overall study."
858826|NCT01206738|O2|Outcome|Post|GPs receiving a postal invitation
858827|NCT01206738|O1|Outcome|Email|GPs receiving an email invitation
858828|NCT01206738|O3|Outcome|General Information|"No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.~General intervention: No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing."
858829|NCT01206738|O2|Outcome|Alternative Intervention|"This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic~Action plan: This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic"
858830|NCT01206738|O1|Outcome|Persuasive Communication|"The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.~Persuasive communication: The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics."
858832|NCT01206738|E2|Reported Event|Alternative Intervention|Action Plan. The work linking simulated prescribing behaviour to predictors of that behaviour suggested that an action plan, detailing situations where GPs found it difficult to not prescribe an antibiotic and offering ways in which the GP could avoid prescribing an antibiotic when this was not necessary.
858833|NCT01206738|E1|Reported Event|Persuasive Communication|The persuasive intervention aimed to reinforce the GP’s beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
858834|NCT01206660|B3|Baseline|Total|Total of all reporting groups
858835|NCT01206660|B2|Baseline|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
858836|NCT01206660|B1|Baseline|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
858837|NCT01206660|P2|Participant Flow|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
858838|NCT01206660|P1|Participant Flow|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
858839|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
858840|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
858841|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
858842|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
858843|NCT01206660|O2|Outcome|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
858844|NCT01206660|O1|Outcome|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
858845|NCT01206660|E2|Reported Event|Placebo|"Placebo administered to affected area twice a day for 28 days~placebo: Placebo administered to affected area twice a day for 28 days"
858846|NCT01206660|E1|Reported Event|Desoximetasone Spray 0.25%|"Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days~Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days"
858847|NCT01206608|B3|Baseline|Total|Total of all reporting groups
858848|NCT01206608|B2|Baseline|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858849|NCT01206608|B1|Baseline|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858850|NCT01206608|P2|Participant Flow|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858854|NCT01206608|E2|Reported Event|Mid-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858855|NCT01206608|E1|Reported Event|Low-dose SKY0402 + Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858856|NCT01206595|B3|Baseline|Total|Total of all reporting groups
858857|NCT01206595|B2|Baseline|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858858|NCT01206595|B1|Baseline|SKY0402|Low-dose, low-mid dose, and mid-dose
858859|NCT01206595|P2|Participant Flow|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858860|NCT01206595|P1|Participant Flow|SKY0402|Low-dose, low-mid dose, and mid-dose
858861|NCT01206595|O4|Outcome|SKY0402 Mid Dose|A single dose of SKY0402 (mid dose) was administered intraoperatively by local infiltration.
858862|NCT01206595|O3|Outcome|SKY0402 Low-Mid Dose|A single dose of SKY0402 (low-mid dose) was administered intraoperatively by local infiltration.
858863|NCT01206595|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 (low dose) was administered intraoperatively by local infiltration.
858864|NCT01206595|O1|Outcome|Bupivacaine HCl|A single dose of bupivacaine HCl 125 mg was administered intraoperatively by local infiltration.
858865|NCT01206595|E2|Reported Event|Bupivacaine HCl|Marcaine with epinephrine 1:200,000 is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
858866|NCT01206595|E1|Reported Event|SKY0402|Low-dose, low-mid dose, and mid-dose
858867|NCT01206582|B3|Baseline|Total|Total of all reporting groups
858868|NCT01206582|B2|Baseline|Albumin|10 iv infusions for 8 weeks
858869|NCT01206582|B1|Baseline|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858870|NCT01206582|P2|Participant Flow|Albumin|10 iv infusions for 8 weeks
858871|NCT01206582|P1|Participant Flow|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, Illinois (IL). Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858872|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858907|NCT01206517|P2|Participant Flow|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
858873|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858874|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858875|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858876|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858877|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858878|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858879|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858880|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858881|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858882|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858883|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858884|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858885|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858886|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858887|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858888|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858889|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858890|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858891|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858892|NCT01206582|O2|Outcome|Albumin|10 iv infusions for 8 weeks
858893|NCT01206582|O1|Outcome|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858894|NCT01206582|E2|Reported Event|Albumin|10 iv infusions for 8 weeks
858895|NCT01206582|E1|Reported Event|Hemin|Panhematin®, Ovation Pharmaceuticals, Deerfield, IL. Hemin was diluted in 25% albumin to obtain a concentration of 2.4 mg/mL and administered at a dose of 1.25 mL/Kg and at a rate of 60 mL/hour. 10 iv infusions for 8 weeks
858896|NCT01206517|B7|Baseline|Total|Total of all reporting groups
858972|NCT01206387|P1|Participant Flow|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858897|NCT01206517|B6|Baseline|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858898|NCT01206517|B5|Baseline|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858899|NCT01206517|B4|Baseline|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858900|NCT01206517|B3|Baseline|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
858901|NCT01206517|B2|Baseline|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
858902|NCT01206517|B1|Baseline|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
858903|NCT01206517|P6|Participant Flow|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858904|NCT01206517|P5|Participant Flow|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858905|NCT01206517|P4|Participant Flow|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858906|NCT01206517|P3|Participant Flow|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
858908|NCT01206517|P1|Participant Flow|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
858909|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858910|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858911|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858912|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
858913|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
858914|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
858915|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858916|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858917|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858918|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
858919|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
858920|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
858921|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858922|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858923|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858924|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
858925|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
858926|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
858927|NCT01206517|O6|Outcome|Asenapine 10 mg - Cohort 3d|Participants 16 or 17 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858928|NCT01206517|O5|Outcome|Asenapine 10 mg - Cohort 3c|Participants 14 or 15 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858929|NCT01206517|O4|Outcome|Asenapine 10 mg - Cohort 3b|Participants 12 or 13 years of age; administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8
858930|NCT01206517|O3|Outcome|Asenapine 10 mg - Cohort 3a|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12
858931|NCT01206517|O2|Outcome|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
858932|NCT01206517|O1|Outcome|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
858954|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
859041|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
858933|NCT01206517|E3|Reported Event|Asenapine 10 mg - Cohort 3a-d|"Participants 10-17 years of age:~Participants 10 or 11 years of age (Cohort 3a); administered asenapine 2.5 mg b.i.d on Days 1-3, asenapine 2.5 mg in the morning and 5 mg in the evening on Day 4, asenapine 5 mg b.i.d. on Days 5-6, asenapine 5 mg in the morning and 10 mg in the evening on Day 7, asenapine 10 mg b.i.d on Days 8-11, and a single asenapine 10 mg dose in the morning on Day 12~Participants 12-17 years of age (Cohort 3b-d); administered asenapine 5 mg b.i.d on Day 1 (an additional day of 5 mg b.i.d could be allowed), asenapine 10 mg b.i.d on Days 2-7, and a single asenapine 10 mg dose in the morning on Day 8"
858934|NCT01206517|E2|Reported Event|Asenapine 5 mg - Cohort 2|Participants 10 or 11 years of age; administered asenapine 5 mg b.i.d on Days 1-6 and a single asenapine 5 mg dose in the morning on Day 7
858935|NCT01206517|E1|Reported Event|Asenapine 2.5 mg - Cohort 1|Participants 10 or 11 years of age; administered asenapine 2.5 mg b.i.d on Days 1-6 and a single asenapine 2.5 mg dose in the morning on Day 7
858936|NCT01206478|B3|Baseline|Total|Total of all reporting groups
858937|NCT01206478|B2|Baseline|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
858938|NCT01206478|B1|Baseline|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
858939|NCT01206478|P2|Participant Flow|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
858940|NCT01206478|P1|Participant Flow|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
858941|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
858942|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
858943|NCT01206478|O2|Outcome|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
858944|NCT01206478|O1|Outcome|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
858945|NCT01206478|E2|Reported Event|Placebo, Megestrol|"Placebo: Placebo (looks like study drug but has no active ingredients) once daily at bedtime.~At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day."
858946|NCT01206478|E1|Reported Event|Amitriptyline, Megestrol|Amitriptyline 1 mg/kg: Amitriptyline 1 mg/kg once daily at bedtime. At Visit 2, after participating in the study for ten weeks, children in both Groups 1 and 2 will receive a prescription for the appetite stimulant megestrol. The dose your child will receive depends on your child's age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
858947|NCT01206452|B3|Baseline|Total|Total of all reporting groups
858948|NCT01206452|B2|Baseline|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858949|NCT01206452|B1|Baseline|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858950|NCT01206452|P2|Participant Flow|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858951|NCT01206452|P1|Participant Flow|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858952|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858953|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858955|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858956|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858957|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858958|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858959|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858960|NCT01206452|O2|Outcome|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858961|NCT01206452|O1|Outcome|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858962|NCT01206452|E2|Reported Event|Ablation Plus Prednisone|"Participants undergo ablation procedure and receive predinisone at protocol determined times.~Prednisone: 60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858963|NCT01206452|E1|Reported Event|Ablation Plus Placebo|"Participants undergo ablation procedure and receive placebo at protocol determined times.~Placebo: 60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure~Ablation Procedure: Atrial Fibrillation (AF) ablation"
858964|NCT01206439|B1|Baseline|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
858965|NCT01206439|P1|Participant Flow|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
858966|NCT01206439|O1|Outcome|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
858967|NCT01206439|E1|Reported Event|Nebivolol 5 or 10 mg, Oral, Daily|"Subject will receive either 5 or 10 mg of oral nebivolol daily. Dose will be determined by control of blood pressure.~nebivolol: nebivolol 5 or 10 mg oral, daily"
858968|NCT01206387|B3|Baseline|Total|Total of all reporting groups
858969|NCT01206387|B2|Baseline|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858970|NCT01206387|B1|Baseline|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858971|NCT01206387|P2|Participant Flow|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858973|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858974|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858975|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858976|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858977|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858978|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858979|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858980|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858981|NCT01206387|O2|Outcome|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858982|NCT01206387|O1|Outcome|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858983|NCT01206387|E2|Reported Event|Placebo|placebo comparator: Placebo administered to affected area twice a day for 28 days
858984|NCT01206387|E1|Reported Event|Desoximetasone Spray 0.25%|Desoximetasone Spray 0.25%: Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
858985|NCT01206322|B3|Baseline|Total|Total of all reporting groups
858986|NCT01206322|B2|Baseline|Diabetics|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
858987|NCT01206322|B1|Baseline|Healthy|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo ( sterilesaline) in type 2 diabetes and the non-diabetic control group.Each participant received a single dose of insulin and a single dose of placebo on 2 consequent days in random order."
858988|NCT01206322|P4|Participant Flow|Control Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
858989|NCT01206322|P3|Participant Flow|Control Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
858990|NCT01206322|P2|Participant Flow|Diabetes Group: Insulin First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
858991|NCT01206322|P1|Participant Flow|Diabetes Group: Placebo First|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo"
858992|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
858993|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
858994|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
858995|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
858996|NCT01206322|O4|Outcome|Control Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
858997|NCT01206322|O3|Outcome|Control Group: Placebo|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R)).
858998|NCT01206322|O2|Outcome|Diabetes Group: Insulin|Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group.
858999|NCT01206322|O1|Outcome|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the control group on cognitive function (Brief Visuospatial Memory test-Revised (BVMT-R))."
859000|NCT01206322|E4|Reported Event|Control Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
859001|NCT01206322|E3|Reported Event|Control Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
859028|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859002|NCT01206322|E2|Reported Event|Diabetes Group: Insulin|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
859003|NCT01206322|E1|Reported Event|Diabetes Group: Placebo|"Comparisons of acute effects of intranasal insulin or placebo on cerebral blood flow and cognition.~Intranasal insulin: The acute effects of a single 40-IU dose of intranasal insulin vs. placebo in type 2 diabetes and the non-diabetic control group.~The intranasal administration of insulin was safe, with no serious adverse events or hypoglycemic episodes and the protocol was feasible for participants."
859004|NCT01206140|B3|Baseline|Total|Total of all reporting groups
859005|NCT01206140|B2|Baseline|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
859006|NCT01206140|B1|Baseline|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
859007|NCT01206140|P2|Participant Flow|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
859008|NCT01206140|P1|Participant Flow|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
859009|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
859010|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
859011|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
859039|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
859195|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
859012|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
859013|NCT01206140|O2|Outcome|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
859014|NCT01206140|O1|Outcome|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
859015|NCT01206140|E2|Reported Event|Arm II (Selumetinib and Temsirolimus)|"Patients receive selumetinib 75 mg PO twice daily on days 1-28 and temsirolimus 25 mg IV over 30-60 minutes on days 1, 8, 15, and 22.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO~Temsirolimus: Given IV"
859016|NCT01206140|E1|Reported Event|Arm I (Selumetinib)|"Patients receive 75 mg selumetinib as in arm II. Patients who experience disease progression may cross over to arm II.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
859017|NCT01206101|B3|Baseline|Total|Total of all reporting groups
859018|NCT01206101|B2|Baseline|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859019|NCT01206101|B1|Baseline|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859020|NCT01206101|P2|Participant Flow|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859021|NCT01206101|P1|Participant Flow|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859022|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859023|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859024|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859025|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859026|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859027|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859029|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859030|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859031|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859032|NCT01206101|O2|Outcome|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859033|NCT01206101|O1|Outcome|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859034|NCT01206101|E2|Reported Event|Liraglutide Placebo|Liraglutide placebo was injected subcutaneously once-daily. The dose of liraglutide placebo was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859035|NCT01206101|E1|Reported Event|Liraglutide|Liraglutide was injected subcutaneously once-daily. The dose of liraglutide was escalated up to 1.8 mg (or 1.2 mg if 1.8 mg not tolerated) prior to islet cell transplant and continued until one year after the first transplant in each subject.
859036|NCT01205828|B1|Baseline|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
859037|NCT01205828|P1|Participant Flow|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
859038|NCT01205828|O1|Outcome|Temozolomide and ABT-888 in HCC Patients|"Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Temozolomide: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days~ABT-888: ABT-888 40 mg BID PO Days 1-7 every 28 days"
859196|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
859042|NCT01205828|O1|Outcome|ABT-888 and Temozolomide|ABT-888 40 mg daily day 1-7/28 and temozolomide 150 mg/m2/day day 1-5/28
859043|NCT01205828|E1|Reported Event|Temozolomide + ABT-888|"Temozolomide and ABT-888~temozolomide + ABT-888: Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days ABT-888 40 mg BID PO Days 1-7 every 28 days~Patents with stable disease or continued response to therapy will be treated and followed for a total of 6 cycles (6 months)."
859044|NCT01205685|B1|Baseline|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
859045|NCT01205685|P1|Participant Flow|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
859046|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
859047|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
859048|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
859049|NCT01205685|O1|Outcome|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
859050|NCT01205685|E1|Reported Event|OSI-906 + Erlotinib + Letrozole + Goserelin|"OSI-906 in a pill form, by mouth, twice a day (12 hours a part)~Erlotinib in a pill form, by mouth, once a day~Letrozole in a pill form, by mouth, once a day~Goserelin, by injection once per month for women who are pre-menopausal"
859051|NCT01205646|B1|Baseline|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
859091|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859092|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859093|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
859094|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859052|NCT01205646|P1|Participant Flow|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
859053|NCT01205646|O1|Outcome|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
859054|NCT01205646|E1|Reported Event|Zometa & PET Scans|"Zoledronate therapy & PET scan ;2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility, Bone scan (within 4 weeks prior to registration), bone turnover markers, and PSA will be obtained pretherapy. After that, Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration.~zoledronate therapy: Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.~PET Scan: 2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration."
859055|NCT01205581|B7|Baseline|Total|Total of all reporting groups
859056|NCT01205581|B6|Baseline|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859057|NCT01205581|B5|Baseline|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859058|NCT01205581|B4|Baseline|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859059|NCT01205581|B3|Baseline|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
859060|NCT01205581|B2|Baseline|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859061|NCT01205581|B1|Baseline|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859062|NCT01205581|P6|Participant Flow|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859063|NCT01205581|P5|Participant Flow|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859064|NCT01205581|P4|Participant Flow|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859065|NCT01205581|P3|Participant Flow|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
859066|NCT01205581|P2|Participant Flow|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859067|NCT01205581|P1|Participant Flow|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859068|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859069|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859070|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859071|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859072|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859073|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859074|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859075|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859076|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859077|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859078|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859079|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859080|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
859081|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
859082|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
859083|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
859084|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
859085|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
859086|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
859087|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
859088|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
859089|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
859090|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859095|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859096|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859097|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859098|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859099|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
859100|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859101|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859102|NCT01205581|O2|Outcome|ALC ≥1000 Cells/mm³|Participants whose ALC was ≥1000 cells/mm³ were analyzed.
859103|NCT01205581|O1|Outcome|ALC <1000 Cells/mm³|Participants whose ALC was <1000 cells/mm³ were analyzed.
859104|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone SD.
859105|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone SD.
859106|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone SD.
859107|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone SD.
859108|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone SD.
859109|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone SD.
859110|NCT01205581|O6|Outcome|HIV-2 Doses|Patients with a diagnosis of HIV who received 2 doses of high dose Fluzone HD.
859111|NCT01205581|O5|Outcome|HIV-1 Dose|Patients with a diagnosis of HIV who received one dose of high dose Fluzone HD.
859112|NCT01205581|O4|Outcome|Solid Tumor-2 Doses|Patients with a diagnosis of solid tumor who received 2 doses of high dose Fluzone HD.
859113|NCT01205581|O3|Outcome|Solid Tumor-1 Dose|Patients with a diagnosis of solid tumor who received one dose of high dose Fluzone HD.
859114|NCT01205581|O2|Outcome|Leukemia-2 Doses|Patients with a diagnosis of leukemia who received 2 doses of high dose Fluzone HD.
859115|NCT01205581|O1|Outcome|Leukemia-1 Dose|Patients with a diagnosis of leukemia who received one dose of high dose Fluzone HD.
859116|NCT01205581|O2|Outcome|Standard Dose Fluzone|42 participants received 82 doses of standard-dose Fluzone.
859117|NCT01205581|O1|Outcome|High-dose FluzoneHD|41 participants received 80 doses of high-dose FluzoneHD.
859118|NCT01205581|O6|Outcome|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859119|NCT01205581|O5|Outcome|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859120|NCT01205581|O4|Outcome|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859121|NCT01205581|O3|Outcome|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
859122|NCT01205581|O2|Outcome|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859123|NCT01205581|O1|Outcome|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859124|NCT01205581|E6|Reported Event|HIV-SD|Patients with a diagnosis of HIV who received the standard dose Fluzone.
859125|NCT01205581|E5|Reported Event|HIV-HD|Patients with a diagnosis of HIV who received the high dose Fluzone HD.
859126|NCT01205581|E4|Reported Event|Solid Tumor-SD|Patients with a diagnosis of solid tumor who received the standard dose Fluzone.
859127|NCT01205581|E3|Reported Event|Solid Tumor-HD|Patients with a diagnosis of solid tumor who received the high dose Fluzone HD.
859128|NCT01205581|E2|Reported Event|Leukemia-SD|Patients with a diagnosis of leukemia who received the standard dose Fluzone.
859129|NCT01205581|E1|Reported Event|Leukemia-HD|Patients with a diagnosis of leukemia who received the high dose Fluzone HD.
859130|NCT01205503|B3|Baseline|Total|Total of all reporting groups
859131|NCT01205503|B2|Baseline|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
859132|NCT01205503|B1|Baseline|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
859133|NCT01205503|P2|Participant Flow|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 1, day 1. Infused over 15 minutes"
859134|NCT01205503|P1|Participant Flow|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
859135|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859153|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859136|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859137|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859138|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859139|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859140|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859141|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859197|NCT01205399|E1|Reported Event|AlloMax Surgical Graft Group|
859198|NCT01205269|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 6 sequences of drug or placebo.
859783|NCT01203072|E4|Reported Event|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
859142|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859143|NCT01205503|O2|Outcome|Cycle 1 Mesna; Cycle 2 Saline|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 1st cycle, then Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859144|NCT01205503|O1|Outcome|Cycle 1 Saline; Cycle 2 Mesna|"Saline infused over 15 minutes administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during 1st cycle, then Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during 2nd cycle~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes~Saline: Saline (used as a placebo) infused over the same time as mesna intervention"
859145|NCT01205503|E2|Reported Event|Saline|"Saline administered prior to and 3 hours post doxorubicin infusion (over 15 minutes) during cycle assigned by randomization~Infused over 15 minutes"
859146|NCT01205503|E1|Reported Event|Mesna|"Mesna administered (infused over 15 minutes, 360 mg/m2) prior to and 3 hours post doxorubicin infusion during cycle assigned by randomization~Mesna: Mesna: 360 mg/m2 in 50 mL normal saline (NS) on cycle 2, day 1. Infused over 15 minutes"
859147|NCT01205451|B3|Baseline|Total|Total of all reporting groups
859148|NCT01205451|B2|Baseline|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859149|NCT01205451|B1|Baseline|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859150|NCT01205451|P2|Participant Flow|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859151|NCT01205451|P1|Participant Flow|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859152|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859229|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859230|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859154|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859155|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859156|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859157|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859158|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859159|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859199|NCT01205269|P6|Participant Flow|First Placebo, Then 50 mcg, Then 200 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period5: AZD8683 200 mcg
861347|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
859160|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859161|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859162|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859163|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859164|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859165|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859166|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859167|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859168|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859169|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859170|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859171|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859172|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859173|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859174|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859175|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859176|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859177|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859178|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859179|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859180|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859181|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859182|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859183|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859184|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859185|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859186|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859231|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859232|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859233|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859187|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859188|NCT01205451|O2|Outcome|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859189|NCT01205451|O1|Outcome|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859190|NCT01205451|E2|Reported Event|Placebo in Original DB Study; BOTOX in OL Study|Participants who had received placebo treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859191|NCT01205451|E1|Reported Event|BOTOX in Original DB Study; BOTOX in OL Study|Participants who had received Botulinum Toxin Type A (BOTOX or GSK1358820) treatment in the previous double-blind study (Study 112958) received BOTOX 200 Units (U) (4 milliliters [mL]) injected into the wrist and finger muscles in this open-label extension study. 40 U (0.8 mL) was injected into the thumb muscles if thumb spasticity was present during the 12-week study (once at Week 0).
859192|NCT01205399|B1|Baseline|AlloMax Surgical Graft Group|
859193|NCT01205399|P1|Participant Flow|AlloMax Surgical Graft Group|The study group included eligible subjects who underwent hernia repair using the AlloMax™ Surgical Graft at least 9 months prior to the start of this study.
859194|NCT01205399|O1|Outcome|AlloMax Surgical Graft Group|
859200|NCT01205269|P5|Participant Flow|First Placebo, Then 200 mcg, Then 50 mcg|period 1: placebo , period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: AZD8683 50 mcg
859201|NCT01205269|P4|Participant Flow|First 200 mcg, Then 50 mcg, Then Placebo|period 1: AZD8683 200 mcg, period 2: washout, period 3: AZD8683 50 mcg, period 4: washout, period 5: placebo
859202|NCT01205269|P3|Participant Flow|First 200 mcg, Then Placebo, Then 50 mcg|period 1: AZD8683 200 mcg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD8683 50 mcg
859203|NCT01205269|P2|Participant Flow|First 50 mcg, Then Placebo, Then 200 mcg|period 1: AZD8683 50 mcg, period 2: washout, period 3: placebo, period 4: washout, period5:AZD8683 200 mcg
859204|NCT01205269|P1|Participant Flow|First 50 mcg, Then 200 mcg, Then Placebo|period 1: AZD8683 50 mcg, period 2: washout, period 3: AZD8683 200 mcg, period 4: washout, period5: placebo
859205|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859206|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859207|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859208|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859209|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859210|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859211|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859212|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859213|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859214|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859215|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859216|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859217|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859218|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859219|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859220|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859221|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859222|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859223|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859224|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859225|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859226|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859227|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859228|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859234|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859235|NCT01205269|O3|Outcome|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859236|NCT01205269|O2|Outcome|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859237|NCT01205269|O1|Outcome|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859238|NCT01205269|E3|Reported Event|Placebo|1 x Placebo Turbuhaler + 3 x Placebo Turbuhaler (dry powder inhaler)
859239|NCT01205269|E2|Reported Event|AZD8683 200 mcg|1 x AZD8683 Turbuhaler 50 mcg + 3 x AZD8683 Turbuhaler 50 mcg (dry powder inhaler)
859240|NCT01205269|E1|Reported Event|AZD8683 50 mcg|1 x AZD8683 Turbuhaler 50mcg + 3x placebo Turbuhaler (dry powder inhaler)
859241|NCT01205230|B3|Baseline|Total|Total of all reporting groups
859242|NCT01205230|B2|Baseline|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
859243|NCT01205230|B1|Baseline|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859244|NCT01205230|P2|Participant Flow|Pazopanib, Followed by Pazopanib + Esomeprazole|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1, followed by pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (approximately 3 hours after the evening meal) for 5 consecutive days during Period 2
859245|NCT01205230|P1|Participant Flow|Pazopanib, Followed by Pazopanib + Ketoconazole|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859246|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859247|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859784|NCT01203072|E3|Reported Event|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
900914|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
859248|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859249|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859250|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859251|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859252|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859253|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859254|NCT01205230|O1|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1, followed by ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859255|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859256|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859257|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859258|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859259|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859260|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859261|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859262|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859263|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859264|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859265|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859266|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859267|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859268|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859269|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859270|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859271|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859272|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859273|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859274|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859275|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859276|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859277|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859278|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859279|NCT01205230|O4|Outcome|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859280|NCT01205230|O3|Outcome|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859281|NCT01205230|O2|Outcome|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859282|NCT01205230|O1|Outcome|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859283|NCT01205230|E4|Reported Event|Pazopanib 800 mg QD + Esomeprazole 40 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD in the morning in combination with esomeprazole 40 mg (1x40 mg capsule) QD in the evening (administered 1 hour after the evening meal) for 5 consecutive days during Period 2
859284|NCT01205230|E3|Reported Event|Pazopanib 800 mg QD|Pazopanib 800 mg (4x200 mg tablets) QD, for at least 7 consecutive days in the morning during Period 1
859285|NCT01205230|E2|Reported Event|Pazopanib 400 mg QD + Ketoconazole 400 mg QD|Ketoconazole 400 mg (2x200 mg tablets) QD in combination with pazopanib 400 mg (2x200 mg tablets) QD for 5 consecutive days in the morning during Period 2
859286|NCT01205230|E1|Reported Event|Pazopanib 400 mg QD|Pazopanib 400 milligrams (mg) (2x200 mg tablets) once daily (QD), for at least 7 consecutive days in the morning during Period 1
859287|NCT01205126|B3|Baseline|Total|Total of all reporting groups
859288|NCT01205126|B2|Baseline|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859289|NCT01205126|B1|Baseline|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859290|NCT01205126|P2|Participant Flow|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859291|NCT01205126|P1|Participant Flow|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859292|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859293|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859294|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859295|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859296|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859367|NCT01204736|E1|Reported Event|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
859297|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859298|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859299|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859300|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859301|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859302|NCT01205126|O2|Outcome|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859303|NCT01205126|O1|Outcome|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859304|NCT01205126|E2|Reported Event|Oxycodone HCl Controlled Release (CR)|Oxycodone HCl was administered in dose of 10, 20, 30, and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859305|NCT01205126|E1|Reported Event|Hydromorphone Hydrochloride (HCl)|Osmotic Release Oral System (OROS) hydromorphone HCl was administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose was based on participant's previous daily opioid dose.
859306|NCT01205035|B3|Baseline|Total|Total of all reporting groups
859785|NCT01203072|E2|Reported Event|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
859307|NCT01205035|B2|Baseline|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859308|NCT01205035|B1|Baseline|Observation|Observation; No treatment given
859309|NCT01205035|P2|Participant Flow|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859310|NCT01205035|P1|Participant Flow|Observation|Observation; No treatment given
859311|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859312|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
859313|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859314|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
859315|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859316|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
859317|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859318|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
859319|NCT01205035|O2|Outcome|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859320|NCT01205035|O1|Outcome|Observation|Observation; No treatment given
859321|NCT01205035|E2|Reported Event|Intravitreal Ranibizumab 2.0mg|"Initial dose 2.0mg switched to 1.0mg at near conclusion of study.~ranibizumab 2.0mg: Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections"
859322|NCT01205035|E1|Reported Event|Observation|Observation; No treatment given
859323|NCT01204853|B1|Baseline|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859324|NCT01204853|P1|Participant Flow|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859325|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859368|NCT01204697|B3|Baseline|Total|Total of all reporting groups
859632|NCT01203956|E3|Reported Event||From data available it cannot be determined which mode the subject was using at the time of this event.
859326|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859327|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859328|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859329|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859330|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859331|NCT01204853|O1|Outcome|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859332|NCT01204853|E1|Reported Event|Sitaxentan Treatment|All participants received one 100 mg film-coated tablet of sitaxentan daily for 12 weeks. Participants who had already received a stable dose of pulmonary arterial hypertension (PAH)-specific drug (sildenafil or beraprost) for at least 3 month prior to screening, continued to receive the PAH-specific drug during study period.
859333|NCT01204788|B3|Baseline|Total|Total of all reporting groups
859786|NCT01203072|E1|Reported Event|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
859787|NCT01203046|B3|Baseline|Total|Total of all reporting groups
859334|NCT01204788|B2|Baseline|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
859335|NCT01204788|B1|Baseline|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
859336|NCT01204788|P2|Participant Flow|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
859337|NCT01204788|P1|Participant Flow|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
859338|NCT01204788|O2|Outcome|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
859339|NCT01204788|O1|Outcome|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
859340|NCT01204788|E2|Reported Event|Arm 2 (Therapeutic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Therapeutic White Cell Transfusion. Radiated white blood cell transfusions daily only with infection (or persistent fever)
859341|NCT01204788|E1|Reported Event|Arm 1 (Prophylactic Arm)|Prophylactic Treatment (standard of care prophylactic antibiotics) + Prophylactic White Cell Transfusion. Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
859342|NCT01204775|B3|Baseline|Total|Total of all reporting groups
859343|NCT01204775|B2|Baseline|Placebo|Placebo matching saxagliptin
859344|NCT01204775|B1|Baseline|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
859345|NCT01204775|P2|Participant Flow|Placebo|Placebo matching saxagliptin
859346|NCT01204775|P1|Participant Flow|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
859347|NCT01204775|O2|Outcome|Placebo|Placebo matching saxagliptin
859348|NCT01204775|O1|Outcome|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
859349|NCT01204775|E2|Reported Event|Saxagliptin|Saxagliptin 2.5 mg or 5 mg depending on body weight
859350|NCT01204775|E1|Reported Event|Placebo|Placebo matching saxagliptin
859351|NCT01204736|B5|Baseline|Total|Total of all reporting groups
859352|NCT01204736|B4|Baseline|Group 4|Unimpaired control subjects
859353|NCT01204736|B3|Baseline|Group 3|Subjects with cervical SCI who have not had tendon transfers
859354|NCT01204736|B2|Baseline|Group 2|Subjects with biceps-to-triceps tendon transfers
859355|NCT01204736|B1|Baseline|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
859356|NCT01204736|P4|Participant Flow|Group 4|Unimpaired control subjects
859357|NCT01204736|P3|Participant Flow|Group 3|Subjects with cervical SCI who have not had tendon transfers
859358|NCT01204736|P2|Participant Flow|Group 2|Subjects with biceps-to-triceps tendon transfers
859359|NCT01204736|P1|Participant Flow|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
859360|NCT01204736|O4|Outcome|Group 4|Unimpaired control subjects
859361|NCT01204736|O3|Outcome|Group 3|Subjects with cervical SCI who have not had tendon transfers
859362|NCT01204736|O2|Outcome|Group 2|Subjects with biceps-to-triceps tendon transfers
859363|NCT01204736|O1|Outcome|Group 1|Subjects with posterior deltoid-to-triceps tendon transfers
859364|NCT01204736|E4|Reported Event|Group 4|Unimpaired control subjects
859365|NCT01204736|E3|Reported Event|Group 3|Subjects with cervical SCI who have not had tendon transfers
859366|NCT01204736|E2|Reported Event|Group 2|Subjects with biceps-to-triceps tendon transfers
859369|NCT01204697|B2|Baseline|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859370|NCT01204697|B1|Baseline|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
859371|NCT01204697|P2|Participant Flow|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 milligram per square meter (mg/m^2) as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859372|NCT01204697|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose of 150 milligram per day (mg/day) orally as monotherapy, up to progressive disease (PD), death, or unacceptable toxicity.
859373|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859374|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
859375|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859376|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
860291|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
859377|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859378|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
859379|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859380|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
859381|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859382|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
859383|NCT01204697|O2|Outcome|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859384|NCT01204697|O1|Outcome|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
859385|NCT01204697|E2|Reported Event|Docetaxel and Erlotinib|Participants received docetaxel at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 3-week cycle, and erlotinib at a dose of 150 mg/day orally from Day 2 to Day 16 of each 3-week cycle for 4 cycles, administered in absence of PD, death, or unacceptable toxicity. Following the 4 cycles, erlotinib 150 mg/day was administered orally as monotherapy up to PD, death or unacceptable toxicity.
859386|NCT01204697|E1|Reported Event|Erlotinib|Participants received erlotinib at a dose of 150 mg/day orally as monotherapy, up to PD, death, or unacceptable toxicity.
859387|NCT01204671|B6|Baseline|Total|Total of all reporting groups
859388|NCT01204671|B5|Baseline|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859389|NCT01204671|B4|Baseline|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859390|NCT01204671|B3|Baseline|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859391|NCT01204671|B2|Baseline|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859392|NCT01204671|B1|Baseline|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859393|NCT01204671|P5|Participant Flow|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859454|NCT01204658|B5|Baseline|Total|Total of all reporting groups
871518|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
859394|NCT01204671|P4|Participant Flow|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859395|NCT01204671|P3|Participant Flow|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859396|NCT01204671|P2|Participant Flow|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859397|NCT01204671|P1|Participant Flow|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859398|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859399|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859400|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859401|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859402|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859403|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859404|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859405|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859406|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859407|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
859408|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859409|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859410|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859411|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859412|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859413|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859414|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859415|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859416|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859417|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859418|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859419|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859420|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859421|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859422|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859423|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859424|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859425|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859426|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859427|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859428|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859429|NCT01204671|O5|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859430|NCT01204671|O4|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859431|NCT01204671|O3|Outcome|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859432|NCT01204671|O2|Outcome|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859433|NCT01204671|O1|Outcome|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859434|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859435|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859436|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859437|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859438|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859439|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859440|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859441|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859442|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859443|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859444|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859445|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859446|NCT01204671|O3|Outcome|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859447|NCT01204671|O2|Outcome|Fluarix Group|Subjects received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859448|NCT01204671|O1|Outcome|GSK2321138A Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, 2 or 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859449|NCT01204671|E5|Reported Event|GSK2604409A Group|Subjects received one dose of the GSK2604409A vaccine at Day 0. The GSK2604409A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859450|NCT01204671|E4|Reported Event|Fluarix Group|Subjects received one dose of the 1 dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859451|NCT01204671|E3|Reported Event|GSK2321138A Lot 3 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 3, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859452|NCT01204671|E2|Reported Event|GSK2321138A Lot 2 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 2, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859453|NCT01204671|E1|Reported Event|GSK2321138A Lot 1 Group|Subjects received one dose of the GSK2321138A vaccine, Lot 1, at Day 0. The GSK2321138A vaccine was administered as a single dose intramuscularly in the deltoid region of the non-dominant arm.
859455|NCT01204658|B4|Baseline|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859456|NCT01204658|B3|Baseline|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859457|NCT01204658|B2|Baseline|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859638|NCT01203930|P2|Participant Flow|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859458|NCT01204658|B1|Baseline|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859459|NCT01204658|P4|Participant Flow|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859460|NCT01204658|P3|Participant Flow|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859461|NCT01204658|P2|Participant Flow|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859462|NCT01204658|P1|Participant Flow|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859463|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859464|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859465|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859466|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859639|NCT01203930|P1|Participant Flow|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859640|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
860292|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
859467|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859468|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859469|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859470|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859471|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859472|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859473|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859616|NCT01204294|E1|Reported Event|Bigu+Lina|biguanide plus linagliptin
859617|NCT01204255|B1|Baseline|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
859618|NCT01204255|P1|Participant Flow|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
859619|NCT01204255|O1|Outcome|Application of Lorazepam, Diphenhydramine, Haloperidol|Topical application of lorazepam, diphenhydramine, haloperidol
859474|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859475|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
860293|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
859476|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859477|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859478|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859479|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859480|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859481|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859482|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859620|NCT01204255|E1|Reported Event|Arm I|Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
859621|NCT01204203|B1|Baseline|Zoledronic Acid (Zometa)|Zometa (zoledronic acid) 4mg will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.
859633|NCT01203956|E2|Reported Event|Standard|CPAP device used without SmartFlex engaged, either in first or second two-week period.
859483|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859484|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
860294|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
859485|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859486|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859487|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859488|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859489|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859490|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859491|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859492|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859493|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859641|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
859642|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
913031|NCT01051739|P1|Participant Flow|Group 1|glaucoma patients
859494|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859495|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859496|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859497|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859498|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859499|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859500|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859501|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859622|NCT01204203|P1|Participant Flow|Zoledronic Acid (Zometa)|"Zoledronic acid (Zometa) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zoledronic acid (Zometa) will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
859634|NCT01203956|E1|Reported Event|SmartFlex|CPAP device used with SmartFlex engaged, either in first or second two-week period.
859502|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859503|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859504|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859505|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859506|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859507|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859508|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859509|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859510|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859623|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
859635|NCT01203930|B3|Baseline|Total|Total of all reporting groups
859906|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
859511|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859780|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
859512|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859513|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859514|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859515|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859516|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859517|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859518|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859519|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859520|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859539|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859521|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859522|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859523|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859524|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859525|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859526|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859527|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859528|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859529|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859624|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
859757|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
860128|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
859530|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859531|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859532|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859533|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859534|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859535|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859536|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859537|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859538|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859625|NCT01204203|O1|Outcome|Zometa|"Zometa (zoledronic acid) will be administered by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles. This will continue until progression of disease and/or intolerable toxicity.~Zometa: Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes."
859758|NCT01203098|E3|Reported Event|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
859540|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859541|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859542|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859543|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859544|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859545|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859546|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859547|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859548|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859567|NCT01204658|E4|Reported Event|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859549|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859550|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859551|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859552|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859553|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859554|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859555|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859556|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859557|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859626|NCT01204203|E1|Reported Event|Zoledronic Acid (Zometa)|Zoledronic acid (Zometa) will be administered IV-4mg by infusion on Day 1 of a 3-week cycle followed by tumor assessment from CT and/or PET scans every 2 cycles.The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.This will continue until progression of disease and/or intolerable toxicity.
859627|NCT01203956|B1|Baseline|All Evaluable Subjects|All subjects completing both two-week periods of crossover study, with evaluable results for each period.
860129|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
859558|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859559|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859560|NCT01204658|O1|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859561|NCT01204658|O2|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859562|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859563|NCT01204658|O4|Outcome|Prevnar 13/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Prevnar 13™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Prevnar 13™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Prevnar 13™ and on the right side for Infanrix hexa™.
859564|NCT01204658|O3|Outcome|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859565|NCT01204658|O2|Outcome|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859566|NCT01204658|O1|Outcome|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859628|NCT01203956|P2|Participant Flow|Standard First, Then Smartflex|First two weeks without Smartflex engaged, second two weeks with Smartflex engaged
859629|NCT01203956|P1|Participant Flow|SmartFlex First, Then Standard|First two weeks with Smartflex engaged, second two weeks without Smartflex engaged
859630|NCT01203956|O2|Outcome|Standard|Used CPAP device without SmartFlex engaged, in either first or second two-week period.
859631|NCT01203956|O1|Outcome|SmartFlex|Used CPAP device with SmartFlex engaged, in either first or second two-week period.
859568|NCT01204658|E3|Reported Event|Synflorix/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of Synflorix™ vaccine, co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of Synflorix™ and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for Synflorix™ and on the right side for Infanrix hexa™.
859569|NCT01204658|E2|Reported Event|10PP-HD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with high doses (HD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD), co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859570|NCT01204658|E1|Reported Event|10PP-LD/Infanrix Hexa Group|This group consisted in infants aged 6-14 weeks at primary vaccination who received a 3-dose primary vaccination of the GSK 2189242A (or 10PP) vaccine combined with low doses (LD) of pneumococcal pneumolysin toxoid proteins (dPly) and pneumococcal histidine protein D (PhtD) co-administered with the Infanrix hexa™ vaccine at Study Months 0, 1 and 2. Subjects also received a booster dose of each of these vaccines, administered at Study Month 10. The 3 primary doses of the 10PP and Infanrix hexa™ vaccines were administered intramuscularly (IM) in the thigh, on the right and left side, respectively. Booster doses were administered IM into the deltoid or thigh if the deltoid muscle size was not adequate, on the left side for the 10PP vaccine and on the right side for Infanrix hexa™.
859571|NCT01204398|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859572|NCT01204398|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859573|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859574|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859575|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859576|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859577|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859578|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859579|NCT01204398|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
859580|NCT01204398|E1|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
859581|NCT01204294|B8|Baseline|Total|Total of all reporting groups
859582|NCT01204294|B7|Baseline|A-GI+Met|alpha-glucosidase inhibitor plus metformin
859583|NCT01204294|B6|Baseline|SU+Met|sulfonylurea plus metformin
859584|NCT01204294|B5|Baseline|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
859585|NCT01204294|B4|Baseline|SU+Lina|sulfonylurea plus linagliptin
859586|NCT01204294|B3|Baseline|Glit+Lina|glitazone plus linagliptin
859587|NCT01204294|B2|Baseline|Glin+Lina|glinide plus linagliptin
859588|NCT01204294|B1|Baseline|Bigu+Lina|biguanide plus linagliptin
859589|NCT01204294|P7|Participant Flow|A-GI+Met|alpha-glucosidase inhibitor plus metformin
859590|NCT01204294|P6|Participant Flow|SU+Met|sulfonylurea plus metformin
859591|NCT01204294|P5|Participant Flow|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
859592|NCT01204294|P4|Participant Flow|SU+Lina|sulfonylurea plus linagliptin
859593|NCT01204294|P3|Participant Flow|Glit+Lina|glitazone plus linagliptin
859594|NCT01204294|P2|Participant Flow|Glin+Lina|glinide plus linagliptin
859595|NCT01204294|P1|Participant Flow|Bigu+Lina|biguanide plus linagliptin
859596|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
859597|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
859598|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
859599|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
859600|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
859601|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
859602|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
859603|NCT01204294|O7|Outcome|A-GI+Met|alpha-glucosidase inhibitor plus metformin
859604|NCT01204294|O6|Outcome|SU+Met|sulfonylurea plus metformin
859605|NCT01204294|O5|Outcome|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
859606|NCT01204294|O4|Outcome|SU+Lina|sulfonylurea plus linagliptin
859607|NCT01204294|O3|Outcome|Glit+Lina|glitazone plus linagliptin
859608|NCT01204294|O2|Outcome|Glin+Lina|glinide plus linagliptin
859609|NCT01204294|O1|Outcome|Bigu+Lina|biguanide plus linagliptin
859610|NCT01204294|E7|Reported Event|A-GI+Met|alpha-glucosidase inhibitor plus metformin
859611|NCT01204294|E6|Reported Event|SU+Met|sulfonylurea plus metformin
859612|NCT01204294|E5|Reported Event|A-GI+Lina|alpha-glucosidase inhibitor plus linagliptin
859613|NCT01204294|E4|Reported Event|SU+Lina|sulfonylurea plus linagliptin
859614|NCT01204294|E3|Reported Event|Glit+Lina|glitazone plus linagliptin
859615|NCT01204294|E2|Reported Event|Glin+Lina|glinide plus linagliptin
859636|NCT01203930|B2|Baseline|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859637|NCT01203930|B1|Baseline|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
859781|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
859643|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses. Participants who completed 12 cycles of idelalisib were eligible to continue treatment on an extension study (101-99).
859644|NCT01203930|O1|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859645|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859646|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859647|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859648|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859649|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859650|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859651|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859652|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859653|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859654|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859655|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859656|NCT01203930|O2|Outcome|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859657|NCT01203930|O1|Outcome|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859658|NCT01203930|E2|Reported Event|Idelalisib (Cohort 2)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle until disease progression or unacceptable toxicity
859659|NCT01203930|E1|Reported Event|Idelalisib+Rituximab (Cohort 1)|Idelalisib 150 mg capsules or tablets administered orally twice daily of each 28-day cycle for 12 cycles + rituximab 375 mg/m^2 administered intravenously weekly for 8 doses
859660|NCT01203917|B1|Baseline|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859661|NCT01203917|P1|Participant Flow|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859662|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859663|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859664|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859759|NCT01203098|E2|Reported Event|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
859665|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859666|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859667|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859668|NCT01203917|O1|Outcome|Gefitinib|Gefitinib 250 mg oral tablets once daily, administered continuously from Visit 2 until objective disease progression was documented or any other criterion for discontinuation was met. Gefitinib tablets were taken at approximately the same time each day.
859669|NCT01203917|E1|Reported Event|Gefitinib 250 mg|
859670|NCT01203878|B4|Baseline|Total|Total of all reporting groups
859671|NCT01203878|B3|Baseline|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period,
859672|NCT01203878|B2|Baseline|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
859673|NCT01203878|B1|Baseline|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
859674|NCT01203878|P3|Participant Flow|Non-randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period
859675|NCT01203878|P2|Participant Flow|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
859676|NCT01203878|P1|Participant Flow|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
859677|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
859678|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
859679|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
859680|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
859681|NCT01203878|O2|Outcome|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
859682|NCT01203878|O1|Outcome|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
859683|NCT01203878|E3|Reported Event|Non-Randomized|Imiquimod 3.75% applied to the entire face daily for up to 2 2-week cycles separated by a 2-week no treatment period.
859684|NCT01203878|E2|Reported Event|Imiquimod Followed by Observation|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by observation
859685|NCT01203878|E1|Reported Event|Imiquimod Followed by Photodynamic Therapy|Imiquimod 3.75% applied to the entire face daily for 2 2-week cycles separated by a 2-week no treatment period, followed by one session of photodynamic therapy of the entire face with aminolevulinic acid and blue light
859686|NCT01203852|B1|Baseline|Metoprolol + Chlorthalidone|"This group was assigned to the following: Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their HBP average or OBP is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks. Then will washout from all study medication. After washout, participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks.~Metoprolol: Metoprolol 50 mg twice daily titrated to 100 mg twice daily~Chlorthalidone: Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily~Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily."
859687|NCT01203852|P1|Participant Flow|Metoprolol + Chlorthalidone|"This group was assigned the following:~(Metoprolol 8 weeks): Metoprolol tartrate 50 mg twice daily for two weeks. After two weeks subjects will be seen in clinic and will have the dose doubled to 100 mg twice daily if either their home blood pressure (HBP) average or office blood pressure (OBP) is > 120/70 mmHg. They will continue on this dose for an additional 6 weeks.~(Washout 2 weeks): Then will washout from all study medication.~(Chlorthalidone 8 weeks): participants will initiate chlorthalidone 25 mg four times per week (Monday, Wednesday, Thursday, Saturday) for two weeks, then 25 mg daily of chlorthalidone for 6 weeks."
859688|NCT01203852|O1|Outcome|Adverse Metabolic Effects|Change in glucose after treatment with study medications
859689|NCT01203852|O3|Outcome|Chlorthalidone Only|Study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
859690|NCT01203852|O2|Outcome|Metorprolol Only|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded.
860130|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
859691|NCT01203852|O1|Outcome|Metoprolol + Chlorthalidone|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. After another set of identical baseline labs, study participants were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
859692|NCT01203852|E1|Reported Event|All Study Participants|Study participants had their current hypertension treatment withdrawn, baseline labs drawn and hypertension documented. Participants were initiated on metoprolol tartrate 50 mg twice daily for two weeks, followed by dose titration to 100 mg twice daily for six additional weeks if blood pressure (BP) > 120/70 mmHg. BP measures were again recorded. Participants entered a washout where metoprolol was titrated, then discontinued, and the patient’s hypertension was re-established. The subjects were initiated on chlorthalidone 25 mg four days per week (Monday, Wednesday, Thursday, Saturday) 15 mg daily for two weeks, followed by 25 mg daily for an additional six weeks.
859693|NCT01203787|B3|Baseline|Total|Total of all reporting groups
859782|NCT01203072|E5|Reported Event|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
917322|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
859694|NCT01203787|B2|Baseline|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13, 200 mg twice daily from Day 14-Day 20, 600 mg daily from Day 21-Day 27, 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859695|NCT01203787|B1|Baseline|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859696|NCT01203787|P2|Participant Flow|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859697|NCT01203787|P1|Participant Flow|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859698|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859699|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859700|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859701|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859702|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859703|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859704|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859705|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859706|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859707|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859708|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|"200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24~Sorafenib Standard Dosing Regimen: Sorafenib 400 mg twice daily until wk 24 or end of treatment"
859709|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|"Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24~Sorafenib Ramp-Up Regimen: 200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily"
859710|NCT01203787|O2|Outcome|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859711|NCT01203787|O1|Outcome|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859712|NCT01203787|E2|Reported Event|Sorafenib Ramp-Up Regimen|200 mg daily from Day 0-Day 13 200 mg twice daily from Day 14-Day 20 600 mg daily from Day 21-Day 27 400 mg twice daily beginning Day 28 until end of treatment or Week 24
859713|NCT01203787|E1|Reported Event|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg (2 tablets of 200 mg) twice daily until end of treatment or week 24
859714|NCT01203644|B3|Baseline|Total|Total of all reporting groups
859715|NCT01203644|B2|Baseline|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
859716|NCT01203644|B1|Baseline|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
859717|NCT01203644|P2|Participant Flow|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
859718|NCT01203644|P1|Participant Flow|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
859719|NCT01203644|O5|Outcome|SKY0402 High Dose|Single administration of SKY0402 (high dose) in a 40-mL volume via local infiltration
859720|NCT01203644|O4|Outcome|SKY0402 High-mid Dose|Single administration of SKY0402 (high-mid dose) in a 40-mL volume via local infiltration
859721|NCT01203644|O3|Outcome|SKY0402 Low-mid Dose|Single administration of SKY0402 (low-mid dose) in a 40-mL volume via local infiltration
859722|NCT01203644|O2|Outcome|SKY0402 Low Dose|Single administration of SKY0402 (low dose) in a 40-mL volume via local infiltration
859760|NCT01203098|E1|Reported Event|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
859761|NCT01203072|B6|Baseline|Total|Total of all reporting groups
859723|NCT01203644|O1|Outcome|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402. Single 100 mg administration of 0.25% solution (i.e., 0.5% diluted 1:1) in a 40-mL volume via local infiltration
859724|NCT01203644|E2|Reported Event|SKY0402|Low dose, low-mid dose, mid-dose, and high dose
859725|NCT01203644|E1|Reported Event|Bupivacaine HCl|(e.g., Marcaine with epinephrine 1:200,000) is the reference-listed drug for bupivacaine and contains the same active, local anesthetic as SKY0402
859726|NCT01203319|B4|Baseline|Total|Total of all reporting groups
859727|NCT01203319|B3|Baseline|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859728|NCT01203319|B2|Baseline|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859729|NCT01203319|B1|Baseline|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859730|NCT01203319|P3|Participant Flow|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859731|NCT01203319|P2|Participant Flow|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859732|NCT01203319|P1|Participant Flow|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859733|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859734|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859735|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859736|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859737|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859738|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859739|NCT01203319|O3|Outcome|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859740|NCT01203319|O2|Outcome|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859741|NCT01203319|O1|Outcome|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859742|NCT01203319|E3|Reported Event|10mcg/1.0ml Recombinant Hepatitis B Vaccine|300 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859743|NCT01203319|E2|Reported Event|30mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859744|NCT01203319|E1|Reported Event|60mcg/1.0ml Recombinant Hepatitis B Vaccine|600 participants aged 16 and older who failed to respond to routine administration of 10mcg recombinant hepatitis B vaccines to receive 60mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
859745|NCT01203098|B4|Baseline|Total|Total of all reporting groups
859746|NCT01203098|B3|Baseline|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
859747|NCT01203098|B2|Baseline|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
859748|NCT01203098|B1|Baseline|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
859749|NCT01203098|P3|Participant Flow|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
859750|NCT01203098|P2|Participant Flow|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
859751|NCT01203098|P1|Participant Flow|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
859752|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
859753|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
859754|NCT01203098|O1|Outcome|DU-176b 15 mg|DU-176b 15 mg tablets, oral once daily for 2 weeks
859755|NCT01203098|O3|Outcome|Enoxaparin Sodium 20mg (2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks
859756|NCT01203098|O2|Outcome|DU-176b 30 mg|DU-176b 30 mg tablets oral, once daily for 2 weeks
859767|NCT01203072|P5|Participant Flow|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
859768|NCT01203072|P4|Participant Flow|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
859769|NCT01203072|P3|Participant Flow|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
859770|NCT01203072|P2|Participant Flow|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
859771|NCT01203072|P1|Participant Flow|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
859772|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
859773|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
859774|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
859775|NCT01203072|O2|Outcome|DU-176b 15 mg|DU-176b: DU-176b 15mg tablets, oral once daily for 2 weeks
859776|NCT01203072|O1|Outcome|DU-176b 5 mg|DU-176b: DU-176b 5mg tablets oral, once daily for 2 weeks
859777|NCT01203072|O5|Outcome|Placebo|Placebo: Matching placebo oral tablets, once daily for 2 weeks
859778|NCT01203072|O4|Outcome|DU-176b 60 mg|DU-176b: DU-176b 60 mg tablets, oral, once daily for 2 weeks
859779|NCT01203072|O3|Outcome|DU-176b 30 mg|DU-176b: DU-176b 30 mg tablets, oral, once daily for 2 weeks
859788|NCT01203046|B2|Baseline|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
859789|NCT01203046|B1|Baseline|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
859790|NCT01203046|P2|Participant Flow|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
859791|NCT01203046|P1|Participant Flow|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
859792|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|Patients with 3 days therapy
859793|NCT01203046|O1|Outcome|GROUP A - 7 DAYS THERAPY|Patients with 7 days therapy
859794|NCT01203046|O2|Outcome|GROUP B - 3 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
859795|NCT01203046|O1|Outcome|GROUP A: 7 DAYS THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
859796|NCT01203046|E2|Reported Event|GROUP B: 3 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group B will be treated with placebo during the following four days."
859797|NCT01203046|E1|Reported Event|GROUP A: 7 DAYS ANTIBIOTIC THERAPY|"Ertapenem will be administrated within the first 2 hours of Hospital´s admission and the next two days after surgery. At day four, patients will be assigned to different groups A or B, according to they entrance number into this trial.~Group A will be treated with Ertapenem during the following four days."
859798|NCT01202955|B3|Baseline|Total|Total of all reporting groups
859799|NCT01202955|B2|Baseline|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859800|NCT01202955|B1|Baseline|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859801|NCT01202955|P2|Participant Flow|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859802|NCT01202955|P1|Participant Flow|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859803|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859804|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
860131|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
859805|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859806|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859807|NCT01202955|O2|Outcome|Placebo First, Then Tolcapone|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859808|NCT01202955|O1|Outcome|Tolcapone First, Then Placebo|Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally
859809|NCT01202955|E2|Reported Event|Placebo First, Then Tolcapone|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
859810|NCT01202955|E1|Reported Event|Tolcapone First, Then Placebo|"To maintain the study blind, both the active Tolcapone and placebo medication periods used an increased-titration dose. Below is the breakdown of the increase in dosing of the active Tolcapone:~Day 1: 100mg three times per day orally Day 2 – Day 7: 200mg three times per day orally Day 8: 200mg twice a day orally Day 9: 200mg once a day orally Day 10: 100mg once a day orally~During the placebo period, all participants followed the above dosing schedule; however, the capsules contained no tolcapone."
859811|NCT01202903|B3|Baseline|Total|Total of all reporting groups
859812|NCT01202903|B2|Baseline|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
917323|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
859813|NCT01202903|B1|Baseline|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859814|NCT01202903|P2|Participant Flow|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859815|NCT01202903|P1|Participant Flow|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859816|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859817|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859818|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859819|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859820|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859821|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859822|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859823|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859824|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859825|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859826|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859827|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859828|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859829|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859830|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859831|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859832|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859833|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859834|NCT01202903|O2|Outcome|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859868|NCT01202643|B2|Baseline|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
859835|NCT01202903|O1|Outcome|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859836|NCT01202903|E2|Reported Event|Placebo|The placebo was the same mixture of inactive excipients, in quality and quantity, as those used for the drug product. The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
859837|NCT01202903|E1|Reported Event|Omalizumab|Omalizumab was supplied as lyophilized, sterile powder in a single-use, 5 mL vial that was designed to deliver 150 mg of omalizumab for subcutaneous administration upon reconstitution with 1.4 mL sterile water for injection. The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
859838|NCT01202877|B4|Baseline|Total|Total of all reporting groups
859839|NCT01202877|B3|Baseline|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
859840|NCT01202877|B2|Baseline|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859841|NCT01202877|B1|Baseline|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine (AZA) 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859842|NCT01202877|P3|Participant Flow|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
859843|NCT01202877|P2|Participant Flow|Phase I: 5-azacytidine + PKC412 50 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859844|NCT01202877|P1|Participant Flow|Phase I: 5-azacytidine + PKC412 25 mg|5-azacytidine 75 mg/m2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859845|NCT01202877|O1|Outcome|5-azacytidine + PKC412|"5-azacytidine 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).~5-azacytidine: Starting dose: 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle.~PKC412: Starting dose: 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily)."
859846|NCT01202877|O3|Outcome|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
859847|NCT01202877|O2|Outcome|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859848|NCT01202877|O1|Outcome|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859849|NCT01202877|E3|Reported Event|Phase II: 5-azacytidine + PKC412|AZA 75 mg/m^2 on days 1-7 and PKC412 Midostaurin 50 mg bid orally on day 8-21 during the first cycle and continuously thereafter.
859850|NCT01202877|E2|Reported Event|Phase I: 5-azacytidine + PKC412 50 mg|AZA 75 mg/m^2/day SQ or IV on days 1-7 of a 28 day cycle. PKC412 50 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859851|NCT01202877|E1|Reported Event|Phase I: 5-azacytidine + PKC412 25 mg|AZA 75 mg/m^2/day subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle. PKC412 25 mg orally twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
859852|NCT01202747|B1|Baseline|LipiFlow Treatment|Treatment with LipiFlow device
859853|NCT01202747|P1|Participant Flow|LipiFlow Treatment|Treatment with LipiFlow device
859854|NCT01202747|O1|Outcome|LipiFlow Treatment|Treatment with LipiFlow device
859857|NCT01202656|B2|Baseline|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation~then~G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
859858|NCT01202656|B1|Baseline|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation~then~Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
859859|NCT01202656|P2|Participant Flow|Saline Then G-CSF|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
859860|NCT01202656|P1|Participant Flow|G-CSF Then Saline|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of human chorionic gonadotropin(hCG) trigger for Ovulation"
859861|NCT01202656|O2|Outcome|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
859862|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
859863|NCT01202656|O2|Outcome|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
859864|NCT01202656|O1|Outcome|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
859865|NCT01202656|E2|Reported Event|Saline|"Normal Saline~Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation"
859866|NCT01202656|E1|Reported Event|G-CSF|"G-CSF (Granulocyte colony stimulating factor)~G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation"
859867|NCT01202643|B3|Baseline|Total|Total of all reporting groups
859869|NCT01202643|B1|Baseline|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
859870|NCT01202643|P2|Participant Flow|Saline Then G-CSF|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation then G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
859871|NCT01202643|P1|Participant Flow|G-CSF Then Saline|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation then Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
859872|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
859873|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
859874|NCT01202643|O2|Outcome|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
859875|NCT01202643|O1|Outcome|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
859876|NCT01202643|E2|Reported Event|Saline|Saline administered by trans-cervical infusion one time on day of hCG trigger for ovulation
859877|NCT01202643|E1|Reported Event|G-CSF|G-CSF 300 units administered by trans-cervical infusion one time on day of hCG trigger for Ovulation
859878|NCT01202591|B7|Baseline|Total|Total of all reporting groups
859879|NCT01202591|B6|Baseline|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
859880|NCT01202591|B5|Baseline|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
859881|NCT01202591|B4|Baseline|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
859882|NCT01202591|B3|Baseline|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
859883|NCT01202591|B2|Baseline|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
859884|NCT01202591|B1|Baseline|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
859885|NCT01202591|P6|Participant Flow|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
859886|NCT01202591|P5|Participant Flow|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
859887|NCT01202591|P4|Participant Flow|AZD4547 80mg bd 2w/1w + Ex|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
859888|NCT01202591|P3|Participant Flow|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
859889|NCT01202591|P2|Participant Flow|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
859890|NCT01202591|P1|Participant Flow|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
859891|NCT01202591|O6|Outcome|Part B: Placebo + Fulvestrant|80mg Placebo BD + 500 mg Fulvestrant
859892|NCT01202591|O5|Outcome|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
859893|NCT01202591|O4|Outcome|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 BD two week on/one week off + 25 mg exemestane
859894|NCT01202591|O3|Outcome|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 bd one week on/one week off + 25 mg exemestane
859895|NCT01202591|O2|Outcome|AZD4547 40mg Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
859896|NCT01202591|O1|Outcome|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 BD continuous + 25 mg exemestane
859897|NCT01202591|E6|Reported Event|Part B: Placebo + Fulvestrant|80 mg Placebo BD + 500 mg Fulvestrant
859898|NCT01202591|E5|Reported Event|Part B: AZD4547 + Fulvestrant|80 mg AZD4547 BD + 500 mg Fulvestrant
859899|NCT01202591|E4|Reported Event|AZD4547 80mg bd 2w/1w + Ex 25mg|80 mg AZD4547 bd two week on/one week off + 25 mg exemestane
859900|NCT01202591|E3|Reported Event|AZD4547 80mg bd 1w/1w + Ex 25mg|80 mg AZD4547 BD one week on/one week off + 25 mg exemestane
859901|NCT01202591|E2|Reported Event|AZD4547 40mg bd Cont + Ex 25mg|40 mg AZD4547 BD continuous + 25 mg exemestane
859902|NCT01202591|E1|Reported Event|AZD4547 80mg bd Cont + Ex 25mg|80 mg AZD4547 bd continuous + 25 mg exemestane
859903|NCT01202578|B1|Baseline|Tympanostomy Tube Placement Using the Tube Delivery System|
859907|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
859908|NCT01202578|O1|Outcome|Tympanostomy Tube Placement Using the Tube Delivery System|
859909|NCT01202578|E1|Reported Event|Safety Events|Safety in terms of number affected subjects in total number of subjects.
859910|NCT01202565|B1|Baseline|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859911|NCT01202565|P1|Participant Flow|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859912|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859913|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859914|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859915|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859916|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859917|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859918|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
861348|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
859919|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859920|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859921|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859922|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859923|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859924|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859925|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859926|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859927|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859928|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859929|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859930|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859931|NCT01202565|O1|Outcome|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859932|NCT01202565|E1|Reported Event|Adalimumab|Participants with moderate to severe plaque psoriasis received adalimumab (Humira®) therapy according to the local product label and prescription/reimbursement guidelines.
859933|NCT01202279|B3|Baseline|Total|Total of all reporting groups
859934|NCT01202279|B2|Baseline|Placebo|Placebo given bid with a full glass of water for 7 days
859935|NCT01202279|B1|Baseline|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
859936|NCT01202279|P2|Participant Flow|Placebo|Placebo given bid with a full glass of water for 7 days
859937|NCT01202279|P1|Participant Flow|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
859938|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
859939|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
859940|NCT01202279|O2|Outcome|Placebo|Placebo given bid with a full glass of water for 7 days
859941|NCT01202279|O1|Outcome|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
859942|NCT01202279|E2|Reported Event|Placebo|Placebo given bid with a full glass of water for 7 days
859943|NCT01202279|E1|Reported Event|Mucinex D|Mucinex D (1200 mg GGE and 120 mg pseudoephedrine HCl extended release bilayer tablet bid with a full glass of water for 7 days
859944|NCT01202253|B1|Baseline|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
860132|NCT01202162|O1|Outcome|Desflurane|Administration of Desflurane
859945|NCT01202253|P1|Participant Flow|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
859946|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859947|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859948|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859949|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859950|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859951|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859952|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859953|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859954|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
860295|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
859955|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859956|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859957|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859958|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859959|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859960|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859961|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859962|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859963|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859964|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859965|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859966|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859967|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859968|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859969|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859970|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859971|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859972|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859973|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859974|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859975|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859976|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859977|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
871519|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
859978|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
859979|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859980|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
859981|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
859982|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
859983|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859984|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859985|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
859986|NCT01202253|O1|Outcome|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator's discretion.
859987|NCT01202253|E1|Reported Event|Anidulafungin|Anidulafungin (Ecalta) 200 milligram (mg) intravenous infusion on the first day followed by 100 mg intravenous infusion once daily as per investigator’s discretion.
859988|NCT01202227|B1|Baseline|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859989|NCT01202227|P1|Participant Flow|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859990|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859991|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859992|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859993|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859994|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859995|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859996|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860133|NCT01202162|E2|Reported Event|Sevoflurane|Administration of Sevoflurane
859997|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859998|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
859999|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860018|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860162|NCT01201967|B2|Baseline|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
860000|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860001|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860002|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860003|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860004|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860005|NCT01202227|O1|Outcome|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860006|NCT01202227|E1|Reported Event|Pregabalin|Study period consisted of 4-week dose adjustment phase followed by 48-week maintenance and one-week tapering phase. All participants were given pregabalin twice a day (BID) in the morning and evening. Participants first received 75 milligram (mg) of pregabalin in the evening of Day 1, and then 150 mg/day from Day 2 onward during the first week. The dosage could be adjusted to the maintenance dose of 150, 300, 450, or 600 mg/day by one step (±150 mg/day) in consideration of safety and efficacy on pain control during the dose adjustment phase.
860007|NCT01202188|B6|Baseline|Total|Total of all reporting groups
860008|NCT01202188|B5|Baseline|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860009|NCT01202188|B4|Baseline|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860010|NCT01202188|B3|Baseline|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860011|NCT01202188|B2|Baseline|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860012|NCT01202188|B1|Baseline|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860013|NCT01202188|P5|Participant Flow|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860014|NCT01202188|P4|Participant Flow|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860015|NCT01202188|P3|Participant Flow|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860016|NCT01202188|P2|Participant Flow|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860017|NCT01202188|P1|Participant Flow|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860019|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860020|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860021|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860022|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860023|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860024|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860025|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860026|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860027|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860028|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860029|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860030|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860031|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860032|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860033|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860034|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860134|NCT01202162|E1|Reported Event|Desflurane|Administration of Desflurane
860135|NCT01202110|B1|Baseline|Control|Control
860136|NCT01202110|P2|Participant Flow|Propranolol|Propranolol
860035|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860036|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860037|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860038|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860039|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860040|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860041|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860042|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860043|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860044|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860045|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860046|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860047|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860048|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860049|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860050|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860051|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860052|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860053|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860054|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860055|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860056|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860137|NCT01202110|P1|Participant Flow|Control|Control
860138|NCT01202110|O1|Outcome|Propranolol|0
860139|NCT01202110|E1|Reported Event|Control|10
860057|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860058|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860059|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860060|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860061|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860062|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860063|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860064|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860065|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860066|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860067|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860068|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860069|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860070|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860071|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860072|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860073|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860074|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860075|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860076|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860077|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860078|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860324|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
878866|NCT01151436|O1|Outcome|Hyaluronic Acid|
860079|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860080|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860081|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860082|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860083|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860084|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860085|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860086|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860087|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860088|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860089|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860090|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860091|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860092|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860093|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860094|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860095|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860096|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860097|NCT01202188|O5|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860098|NCT01202188|O4|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860099|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860100|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860325|NCT01201798|E2|Reported Event|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860101|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860102|NCT01202188|O2|Outcome|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via the manufacturer's proprietary device for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860103|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860104|NCT01202188|O4|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860105|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860106|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860107|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860108|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860109|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860110|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860111|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860112|NCT01202188|O2|Outcome|Placebo|Matching Placebo capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860113|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860114|NCT01202188|O3|Outcome|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks.Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860115|NCT01202188|O2|Outcome|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via a SDDPI for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860116|NCT01202188|O1|Outcome|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDPPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and Salbutamol/albuterol was available for use as rescue medication throughout the study.
860117|NCT01202188|E5|Reported Event|Placebo|Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860118|NCT01202188|E4|Reported Event|Tiotropium|Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860119|NCT01202188|E3|Reported Event|Glycopyrronium (NVA237)|NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860120|NCT01202188|E2|Reported Event|Indacaterol (QAB149)|QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860121|NCT01202188|E1|Reported Event|Indacaterol and Glycopyrronium (QVA149)|QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
860122|NCT01202162|B3|Baseline|Total|Total of all reporting groups
860123|NCT01202162|B2|Baseline|Sevoflurane|Administration of Sevoflurane
860124|NCT01202162|B1|Baseline|Desflurane|Administration of Desflurane
860125|NCT01202162|P2|Participant Flow|Sevoflurane|Administration of Sevoflurane
860126|NCT01202162|P1|Participant Flow|Desflurane|Administration of Desflurane
860127|NCT01202162|O2|Outcome|Sevoflurane|Administration of Sevoflurane
860140|NCT01202071|B1|Baseline|Entire Study Population: Group A, Group B, Group C, Group D|"Includes Group A, Group B, Group C, and Group D. Participants received Rabeprazole sodium Tablets for 5 days in each period.~Group A Period I: 5 mg, Period II: 10 mg, Period III: 20 mg, Period IV: 40 mg~Group B Period I: 10 mg, Period II: 20 mg, Period III: 40 mg, Period IV: 5 mg~Group C Period I: 20 mg, Period II: 40 mg, Period III: 5 mg, Period IV: 10 mg~Group D Period I: 40 mg, Period II: 5 mg, Period III: 10 mg, Period IV: 20 mg~Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV, a washout period consisted of 6 days or longer between each period."
860141|NCT01202071|P4|Participant Flow|Group D: Rapeprazole 40 mg, Then 5 mg, Then 10 mg, Then 20 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 40 mg; Period II (8 days total): 5 mg; Period III (8 days total): 10 mg; Period IV (8 days total): 20 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
860142|NCT01202071|P3|Participant Flow|Group C: Rapeprazole 20 mg, Then 40 mg, Then 5 mg, Then 10 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 20 mg; Period II (8 days total): 40 mg; Period III (8 days total): 5 mg; Period IV (8 days total): 10 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
860287|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860143|NCT01202071|P2|Participant Flow|Group B: Rapeprazole 10 mg, Then 20 mg, Then 40 mg, Then 5 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 10 mg; Period II (8 days total): 20 mg; Period III (8 days total): 40 mg; Period IV (8 days total): 5 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
860144|NCT01202071|P1|Participant Flow|Group A: Rapeprazole 5 mg, Then 10 mg, Then 20 mg, Then 40 mg|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Period I (9 days total): 5 mg; Period II (8 days total): 10 mg; Period III (8 days total): 20 mg; Period IV (8 days total): 40 mg~Each Period was separated by a >= 6 day washout period.~Lastly, a follow-up exam, 7 days after Period IV discharge, up to 14 days allowed after discharge."
860145|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
860146|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
860147|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
860148|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
860149|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
860150|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
860151|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
860152|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
860153|NCT01202071|O4|Outcome|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
860154|NCT01202071|O3|Outcome|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
860155|NCT01202071|O2|Outcome|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
860156|NCT01202071|O1|Outcome|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
860157|NCT01202071|E4|Reported Event|Rabeprazole Sodium 40 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 40 mg was received by:~Group A in Period IV; Group B in Period III; Group C in Period II; Group D in Period I"
860158|NCT01202071|E3|Reported Event|Rabeprazole Sodium 20 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 20 mg was received by:~Group A in Period III; Group B in Period II; Group C in Period I; Group D in Period IV"
860159|NCT01202071|E2|Reported Event|Rabeprazole Sodium 10 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 10 mg was received by:~Group A in Period II; Group B in Period I; Group C in Period IV; Group D in Period III"
860160|NCT01202071|E1|Reported Event|Rabeprazole Sodium 5 mg Tablet|"Participants started with a screening period 4 weeks prior to start of administration, followed by study periods I-IV where participants received 5 days of drug administration in each period.~Rabeprazole sodium 5 mg was received by:~Group A in Period I; Group B in Period IV; Group C in Period III; Group D in Period II"
860161|NCT01201967|B3|Baseline|Total|Total of all reporting groups
860288|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860163|NCT01201967|B1|Baseline|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860164|NCT01201967|P2|Participant Flow|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
860165|NCT01201967|P1|Participant Flow|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860166|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
860167|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860168|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
860169|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860170|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
860171|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860172|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
860173|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860174|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
860175|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860176|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
860177|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860178|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
860326|NCT01201798|E1|Reported Event|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
878867|NCT01151436|O1|Outcome|Hyaluronic Acid|
860179|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860180|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
860181|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860182|NCT01201967|O2|Outcome|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder.~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis."
860183|NCT01201967|O1|Outcome|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
861349|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
860184|NCT01201967|E2|Reported Event|Usual Care|"Patient's physicians are informed of diagnosis of depression/anxiety disorder~Usual care: Patient's primary medical physician informed of mental health symptoms/diagnosis"
860185|NCT01201967|E1|Reported Event|Collaborative Care|"Study care manager provides education and coordinates treatment between study psychiatrist, patient, and primary medical physician. This occurs in the hospital and by phone after discharge. Care manager may also provide phone-based therapy.~Collaborative care: Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians."
860186|NCT01201915|B4|Baseline|Total|Total of all reporting groups
860187|NCT01201915|B3|Baseline|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
860188|NCT01201915|B2|Baseline|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860189|NCT01201915|B1|Baseline|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860190|NCT01201915|P3|Participant Flow|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
860191|NCT01201915|P2|Participant Flow|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860192|NCT01201915|P1|Participant Flow|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860193|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
860194|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860195|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860196|NCT01201915|O3|Outcome|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
860197|NCT01201915|O2|Outcome|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860198|NCT01201915|O1|Outcome|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860199|NCT01201915|E3|Reported Event|Cohort 3: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 8 weeks, followed by 4 weeks with no treatment, followed by a second 8-week vismodegib treatment period.
860200|NCT01201915|E2|Reported Event|Cohort 2: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860201|NCT01201915|E1|Reported Event|Cohort 1: Vismodegib 150 mg|Participants received vismodegib 150 mg orally daily for 12 weeks.
860202|NCT01200810|B3|Baseline|Total|Total of all reporting groups
860203|NCT01200810|B2|Baseline|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860204|NCT01200810|B1|Baseline|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860205|NCT01200810|P2|Participant Flow|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860206|NCT01200810|P1|Participant Flow|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860207|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860208|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860209|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860289|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860210|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860211|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860212|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860213|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860214|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860215|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860216|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860217|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860218|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860219|NCT01200810|O2|Outcome|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860240|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860220|NCT01200810|O1|Outcome|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860221|NCT01200810|E2|Reported Event|Arm II|"Patients receive oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860222|NCT01200810|E1|Reported Event|Arm I|"Patients receive oral placebo once daily on days 1-3, 8-10, and 15-17. Treatment repeats every 21 days for 18 courses in the absence of PSA progression.~COMBINATION PHASE: All patients then receive oral bicalutamide once daily on days 1-21 and oral RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days for 12 months in the absence of disease progression or unacceptable toxicity.~placebo: Given orally~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bicalutamide: Given orally"
860223|NCT01200797|B1|Baseline|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860224|NCT01200797|P1|Participant Flow|Treatment (SJG-136)|SJG-136 was administered consecutively on days 1 - 3 as a 20-minute intravenous infusion, at a dose of 30 mcg/m2/day. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860225|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860226|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860227|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860228|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, consecutively on days 1-3. Treatment courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860229|NCT01200797|O1|Outcome|Treatment (SJG-136)|Patients receive 30 mcg/m2 of SJG-136 intravenously, over a period of 20 minutes, on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860230|NCT01200797|E1|Reported Event|Treatment (SJG-136)|Patients receive SJG-136 IV over 20 minutes on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
860231|NCT01200758|B3|Baseline|Total|Total of all reporting groups
860232|NCT01200758|B2|Baseline|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860233|NCT01200758|B1|Baseline|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860234|NCT01200758|P4|Participant Flow|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860235|NCT01200758|P3|Participant Flow|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860236|NCT01200758|P2|Participant Flow|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860237|NCT01200758|P1|Participant Flow|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 milligrams per square meter [mg/m^2]; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least partial response (PR) during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860238|NCT01200758|O1|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860239|NCT01200758|O1|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860322|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
878868|NCT01151436|E1|Reported Event|Hyaluronic Acid|
860241|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860242|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860243|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860244|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860290|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860245|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860246|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860247|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860248|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860249|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860250|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860251|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860252|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860253|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860254|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860255|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860256|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860257|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860258|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860259|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860260|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860261|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860262|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860263|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860264|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860265|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860266|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860267|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860268|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860269|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860270|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860271|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860272|NCT01200758|O2|Outcome|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860273|NCT01200758|O1|Outcome|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860274|NCT01200758|O2|Outcome|Stage II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860275|NCT01200758|O1|Outcome|Stage II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860276|NCT01200758|O2|Outcome|Stage I: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860277|NCT01200758|O1|Outcome|Stage I: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) in combination with up to 8 cycles of CHOP or CVP chemotherapy (as per institutional practice) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860278|NCT01200758|E2|Reported Event|Stage I and II: Rituximab SC + Chemotherapy (CHOP/CVP)|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC 1400 mg in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
860323|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860400|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860279|NCT01200758|E1|Reported Event|Stage I and II: Rituximab IV + Chemotherapy (CHOP/CVP)|Eight cycles of rituximab IV infusion (375 mg/m^2) in combination with up to 8 cycles of CHOP or CVP chemotherapy administered every 3 weeks. Participants achieving at least PR entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
860280|NCT01201811|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860281|NCT01201811|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860282|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860283|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860284|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860285|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860286|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860296|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860297|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860298|NCT01201811|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860299|NCT01201811|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously (SC) for 7 days every 28 days for up to 6 cycles
860300|NCT01201798|B3|Baseline|Total|Total of all reporting groups
860301|NCT01201798|B2|Baseline|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860302|NCT01201798|B1|Baseline|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860303|NCT01201798|P2|Participant Flow|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860304|NCT01201798|P1|Participant Flow|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860305|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860306|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860307|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860308|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860309|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860310|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860311|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860312|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860313|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860314|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860315|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860316|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860317|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860318|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860319|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860320|NCT01201798|O1|Outcome|Durezol|Difluprednate 0.05% ophthalmic emulsion, 1 drop in study eye, 4 times a day for 14 days, followed by a 14-day tapering period
860321|NCT01201798|O2|Outcome|Pred Forte|Prednisolone acetate 1.0% ophthalmic suspension, 1 drop in study eye, 8 times a day for 14 days, followed by a 14-day tapering period
860327|NCT01201785|B1|Baseline|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
860328|NCT01201785|P1|Participant Flow|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
860329|NCT01201785|O1|Outcome|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
860330|NCT01201785|E1|Reported Event|Aspirin Dose Range|Patients with type 2 DM on aspirin therapy will undergo treatment with escalating aspirin doses. Patients modified their aspirin regimen on a weekly basis according to the following scheme: 81mg/od. 81mg/bid, 162 mg/od, 162 mg/bid, 325mg/od.
860331|NCT01201772|B4|Baseline|Total|Total of all reporting groups
860332|NCT01201772|B3|Baseline|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
860333|NCT01201772|B2|Baseline|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
860334|NCT01201772|B1|Baseline|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
860335|NCT01201772|P3|Participant Flow|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablet
860336|NCT01201772|P2|Participant Flow|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablet
860337|NCT01201772|P1|Participant Flow|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
860338|NCT01201772|O3|Outcome|Prasugrel 60mg|Prasugrel was administered as six 10 mg tablets
860339|NCT01201772|O2|Outcome|Prasugrel 30mg|Prasugrel was administered as three 10 mg tablets
860340|NCT01201772|O1|Outcome|Prasugrel 10mg|Prasugrel was administered as one 10 mg tablet
860341|NCT01201772|E1|Reported Event|All Study Participants|All participants who received prasugrel
860342|NCT01201759|B3|Baseline|Total|Total of all reporting groups
860364|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
860365|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
860343|NCT01201759|B2|Baseline|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
860344|NCT01201759|B1|Baseline|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
860345|NCT01201759|P2|Participant Flow|Salsalate to Placebo 2gr BID|"Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days.~Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2"
860346|NCT01201759|P1|Participant Flow|Placebo to Salsalate 2gr BID|"Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.~Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2."
860347|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
860348|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
860349|NCT01201759|O2|Outcome|Salsalate|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
860350|NCT01201759|O1|Outcome|Placebo|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.: Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
860351|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
860401|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
860402|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860403|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860352|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
860353|NCT01201759|O2|Outcome|Salsalate|Drug: Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
860354|NCT01201759|O1|Outcome|Placebo|Placebo 2 grams twice a day for 30 days. Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
860355|NCT01201759|E2|Reported Event|Salsalate 2gr BID|Salsalate 2grams twice a day for 30 days.
860356|NCT01201759|E1|Reported Event|Placebo 2gr BID|Placebo twice a day for 30 days.
860357|NCT01201629|B3|Baseline|Total|Total of all reporting groups
860358|NCT01201629|B2|Baseline|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
860359|NCT01201629|B1|Baseline|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
860360|NCT01201629|P2|Participant Flow|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
860361|NCT01201629|P1|Participant Flow|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
860362|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
860363|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
860366|NCT01201629|O2|Outcome|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
860367|NCT01201629|O1|Outcome|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
860368|NCT01201629|E2|Reported Event|Sham|8 patient received sham tDCs i.e. after 1 minute of tDCs the machine was off for the next 30 minutes.
860369|NCT01201629|E1|Reported Event|Experimental (tDCs)|t-DCs was administered in 8 patients externally for 30 min at 1 MA Anodal stimulation
860370|NCT01201486|B1|Baseline|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
860371|NCT01201486|P1|Participant Flow|Pregnant Women in Second Trimester|Pregnant females in the 2nd trimester.
860372|NCT01201486|O1|Outcome|Pregnant Women|Pregnant females in the 2nd trimester.
860373|NCT01201486|E1|Reported Event|Pregnant Women|Pregnant females in the 2nd trimester.
860374|NCT01201343|B1|Baseline|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860375|NCT01201343|P1|Participant Flow|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860376|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860377|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860378|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860379|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860380|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860381|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860382|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860383|NCT01201343|O1|Outcome|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860384|NCT01201343|E1|Reported Event|Interferon-beta|Participants received interferon-beta based on investigator's discretion as per the clinical practice for 2 years.
860385|NCT01201317|B4|Baseline|Total|Total of all reporting groups
860386|NCT01201317|B3|Baseline|Placebo|tablets, once daily in the morning
860387|NCT01201317|B2|Baseline|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860388|NCT01201317|B1|Baseline|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860389|NCT01201317|P3|Participant Flow|Placebo|tablets, once daily in the morning
860390|NCT01201317|P2|Participant Flow|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860391|NCT01201317|P1|Participant Flow|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860392|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
860393|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860394|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860395|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
860396|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860397|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860398|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
860399|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860404|NCT01201317|O3|Outcome|Placebo|tablets, once daily in the morning
860405|NCT01201317|O2|Outcome|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860406|NCT01201317|O1|Outcome|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860407|NCT01201317|E3|Reported Event|Placebo|tablets, once daily in the morning
860408|NCT01201317|E2|Reported Event|AZD2423 20 mg|tablets, 20 mg once daily in the morning
860409|NCT01201317|E1|Reported Event|AZD2423 150 mg|tablets, 150 mg once daily in the morning
860410|NCT01201265|B1|Baseline|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860411|NCT01201265|P1|Participant Flow|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860412|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860413|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860414|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860415|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860416|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
917324|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
860417|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860418|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860419|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860420|NCT01201265|O1|Outcome|All Participants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860421|NCT01201265|E1|Reported Event|All Particiapants|Participants received a combination therapy of bevacizumab 15 milligram per kilogram (mg/kg) intravenous every 3 weeks with carboplatin recommended dose (area under curve [AUC]= 2) along with gemcitabine 1000 mg/ metre square (m^2) on days 1 and 8 of each 3 week cycle.
860422|NCT01200992|B3|Baseline|Total|Total of all reporting groups
860423|NCT01200992|B2|Baseline|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
860424|NCT01200992|B1|Baseline|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
860425|NCT01200992|P2|Participant Flow|Mitomycin C|"40 mg mitomycin C mixed with water for injection to a total volume of 40 mL~Mitomycin C: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
860426|NCT01200992|P1|Participant Flow|EN3348|"8 mg EN3348 mixed with water for injection for a total volume of 50mL~EN3348: Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12"
860427|NCT01200992|O2|Outcome|Mitomycin C|"40 mg mixed with water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
860428|NCT01200992|O1|Outcome|EN3348|"8 mg mixed with water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed Maintenance (monthly instillations up to Month 12)"
860429|NCT01200992|E2|Reported Event|Mitomycin C|"40 mg mixed with sterile water for injection to a total volume of 40 mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
860430|NCT01200992|E1|Reported Event|EN3348|"8 mg mixed with sterile water for injection for a total volume of 50mL~Treatment - Induction (6 weekly instillations) followed by Maintenance (monthly instillations up to Month 12)"
860431|NCT01200875|B1|Baseline|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
860432|NCT01200875|P1|Participant Flow|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
860433|NCT01200875|O1|Outcome|PRP Injection (All Patients)|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
860434|NCT01200875|E1|Reported Event|Treatment Arm|All patients receiving local ultrasound-guided intratendinous PRP injection at our institution between July 2010 and December 2011 were screened for eligibility to participate in the study, and 25 patients were ultimately enrolled.
860436|NCT01200602|B2|Baseline|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860437|NCT01200602|B1|Baseline|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860438|NCT01200602|P2|Participant Flow|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860439|NCT01200602|P1|Participant Flow|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860440|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860441|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860442|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860443|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860444|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860445|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860446|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860447|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860448|NCT01200602|O2|Outcome|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860449|NCT01200602|O1|Outcome|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860450|NCT01200602|E2|Reported Event|Arm B|Patients have clinical observation for weight loss and gain for 4 weeks.
860451|NCT01200602|E1|Reported Event|Arm A|Patients receive oral megestrol acetate 1-2 times daily for 4 weeks.
860452|NCT01200524|B4|Baseline|Total|Total of all reporting groups
860453|NCT01200524|B3|Baseline|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860454|NCT01200524|B2|Baseline|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
860455|NCT01200524|B1|Baseline|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
860456|NCT01200524|P3|Participant Flow|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860457|NCT01200524|P2|Participant Flow|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
917325|NCT01037218|O4|Outcome|Placebo|Placebo tablets
860459|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860460|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
860461|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
860462|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860463|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
860464|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
860465|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860466|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
860467|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
860468|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860469|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
860470|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
860471|NCT01200524|O3|Outcome|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860472|NCT01200524|O2|Outcome|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
860473|NCT01200524|O1|Outcome|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
860474|NCT01200524|E3|Reported Event|Placebo|"Tablet to match the 20 mg and 50 mg AZD2423 active tablet~Placebo : Placebo"
860475|NCT01200524|E2|Reported Event|AZD2423, 20mg|AZD2423 : 1x20 mg tablet once daily in the morning
860476|NCT01200524|E1|Reported Event|AZD2423, 150 mg|AZD2423 : 3x50 mg tablet once daily in the morning
860477|NCT01200511|B1|Baseline|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
860478|NCT01200511|P1|Participant Flow|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
860479|NCT01200511|O2|Outcome|ReSTOR +3.0 Toric/With|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, with corrective aids if needed
860480|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric/Without|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation, without corrective aids
860481|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
860482|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
860483|NCT01200511|O1|Outcome|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
860484|NCT01200511|E1|Reported Event|ReSTOR +3.0 Toric|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL, model determined by preoperative keratometric astigmatism, bilateral implantation
860485|NCT01200498|B1|Baseline|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
860486|NCT01200498|P1|Participant Flow|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
860487|NCT01200498|O1|Outcome|SB939|SB939 starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
860488|NCT01200498|E1|Reported Event|SB939|SB939 starting dose 60 mg by mouth every other day, 3 times weekly for 3 weeks.
860489|NCT01200433|B3|Baseline|Total|Total of all reporting groups
860596|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
860490|NCT01200433|B2|Baseline|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860491|NCT01200433|B1|Baseline|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860492|NCT01200433|P2|Participant Flow|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860493|NCT01200433|P1|Participant Flow|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860494|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860495|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860496|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860497|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860498|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860499|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860500|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860501|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860502|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860503|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860504|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860505|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860506|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860507|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860508|NCT01200433|O2|Outcome|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860509|NCT01200433|O1|Outcome|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860510|NCT01200433|E2|Reported Event|Dexmedetomidine|"Subjects will be sedated with dexmedetomidine.~dexmedetomidine: Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure."
860511|NCT01200433|E1|Reported Event|Propofol|"Subjects will be sedated with propofol.~propofol: Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient’s response"
860512|NCT01200368|B4|Baseline|Total|Total of all reporting groups
860513|NCT01200368|B3|Baseline|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860514|NCT01200368|B2|Baseline|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
861317|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
860515|NCT01200368|B1|Baseline|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860516|NCT01200368|P3|Participant Flow|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860517|NCT01200368|P2|Participant Flow|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860518|NCT01200368|P1|Participant Flow|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860519|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860613|NCT01200069|O6|Outcome|Pain Score Ibuprofen 24 Hours After Treatment #1|Subjects reported headache 24 hours after completion of treatment #1
860520|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860521|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860522|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860523|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860524|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860525|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860526|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860527|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860528|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860597|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
860529|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860530|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860531|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860532|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860533|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
861350|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
860534|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860535|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860536|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860537|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860538|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860539|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860540|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860541|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860542|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860598|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported headache 24 hours after completion of treatment #3
861318|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
860543|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860544|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860545|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860546|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860547|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860548|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860549|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860550|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860551|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860552|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860553|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860554|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860555|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860556|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860599|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported headache 6 hours after completion of treatment #3
878869|NCT01151410|B3|Baseline|Total|Total of all reporting groups
860557|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860558|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860559|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860560|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860561|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860562|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860563|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860564|NCT01200368|O3|Outcome|DTaP (Catch-up 7vPnC)|Participants at 3 to 6 months of age received a single 0.5 mL DTaP dose subcutaneously followed by 2 single 0.5 mL DTaP doses subcutaneously, 4 to 8 weeks after each previous dose (infant series). Four to 6 weeks post-infant series, 2 single catch-up (CU) doses of 7vPnC (Prevenar) were administered subcutaneously, 4 to 6 weeks apart. A single 0.5 mL DTaP dose subcutaneously at 12 to 15 months of age (toddler dose) followed by a single CU dose of 7vPnC (Prevenar) subcutaneously 4 to 6 weeks post-toddler dose.
860565|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860566|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860567|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860568|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860569|NCT01200368|O2|Outcome|7vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) subcutaneously followed by 2 single 0.5 mL doses of 7vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 7vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of DTaP subcutaneously administered concomitantly with each 7vPnC dose.
860570|NCT01200368|O1|Outcome|13vPnC + DTaP|Participants at 3 to 6 months of age received a single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) subcutaneously followed by 2 single 0.5 mL doses of 13vPnC subcutaneously, 4 to 8 weeks after each previous dose (infant series) and a single 0.5 mL dose of 13vPnC subcutaneously at 12 to 15 months of age (toddler dose). A single 0.5 mL dose of diphtheria, tetanus, and acellular pertussis vaccine (DTaP) subcutaneously administered concomitantly with each 13vPnC dose.
860571|NCT01200368|E10|Reported Event|DTaP (Catch-up 7vPnC) - After the Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed after the CU Dose 3 to 28 to 42 days post-CU Dose 3.
860572|NCT01200368|E9|Reported Event|DTaP (Catch-up 7vPnC) - Toddler Dose|Participants who received a single 0.5 mL DTaP dose subcutaneously (toddler dose) followed by a single catch-up (CU) dose (CU Dose 3) of 7vPnC (Prevenar) 4 to 6 weeks after toddler dose; assessed from toddler dose through the CU Dose 3.
860573|NCT01200368|E8|Reported Event|7vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 7vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
860574|NCT01200368|E7|Reported Event|13vPnC + DTaP - Toddler Dose|Participants who received a single 0.5 mL dose of 13vPnC subcutaneously (toddler dose) along with 0.5 mL dose of DTaP subcutaneously, assessed from the toddler dose through the blood draw 28 to 42 days post-toddler dose.
860575|NCT01200368|E6|Reported Event|DTaP (Catch-up 7vPnC) - After the Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed after CU Dose 1 to the toddler dose.
860576|NCT01200368|E5|Reported Event|7vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
860577|NCT01200368|E4|Reported Event|13vPnC + DTaP - After the Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed after the infant series blood draw to the toddler dose.
860578|NCT01200368|E3|Reported Event|DTaP (Catch-up 7vPnC) - Infant Series|Participants who received 3 single 0.5 mL DTaP doses subcutaneously 4 to 8 weeks apart (infant series) followed by 2 single catch-up (CU) doses, CU Dose 1 and CU Dose 2 (separated by 4 to 6 weeks), of 7vPnC (Prevenar) 4 to 6 weeks post-infant series, assessed from Infant Dose 1 through the CU Dose 1.
860579|NCT01200368|E2|Reported Event|7vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 7vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
860580|NCT01200368|E1|Reported Event|13vPnC + DTaP - Infant Series|Participants who received 3 single 0.5 mL doses of 13vPnC subcutaneously 4 to 8 weeks apart along with 3 single 0.5 mL doses of DTaP subcutaneously (infant series), assessed from Infant Dose 1 through the blood draw 28 to 42 days post-infant series.
860581|NCT01200342|B1|Baseline|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
860582|NCT01200342|P1|Participant Flow|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
860583|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
860584|NCT01200342|O1|Outcome|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
860585|NCT01200342|E1|Reported Event|Genasense + Paclitaxel + Carboplatin|Genasense 900 mg intravenous (IV) on a fixed-dose as a 1-hour infusion on Days 1, 3, and 5 of a 21 day cycle; Paclitaxel 175 mg/m^2 IV over 3 hours Day 3 after Genasense; Carboplatin dose in mg (target area under the concentration [AUC)]=6) administered over 30 minutes IV Piggyback (IVPB) on Day 3 after Paclitaxel.
860586|NCT01200160|B1|Baseline|Lipid Abnormalities|
860587|NCT01200160|P1|Participant Flow|Lipid Abnormalities|"No comparison groups for this observational study. Patients receive only one type of formulation, then drug exposure was the same for all patients.~This study was conducted in a prospective, single-arm, multi-center format. As this study was observational in nature, the follow-up of subject’s was not prescriptive in nature and was according to the judgment of the investigator, within the period of observation set forth in the protocol.~Typically, Niaspan is titrated in the following manner: After Week 8, titrate to patient response and tolerance. If response to 1000 mg daily is inadequate increase dose to 1500 mg daily; may subsequently increase dose to 2000 mg daily. Ideally, Niaspan should not be increased more than 500 mg in a 4-week period and daily doses above 2000 mg are not recommended. It is expected that women may respond at lower doses than men. However, consult with the approved label for titration recommendation in the particular country."
860588|NCT01200160|O1|Outcome|HDL-Cholesterol|
860589|NCT01200160|E1|Reported Event|Lipid Abnormalities|Those with the condition and exposed to the study drug
860590|NCT01200069|B3|Baseline|Total|Total of all reporting groups
860591|NCT01200069|B2|Baseline|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
860592|NCT01200069|B1|Baseline|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
860593|NCT01200069|P2|Participant Flow|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
860594|NCT01200069|P1|Participant Flow|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
860595|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported headache 48 hours after completion of treatment #3
860600|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported headache 6 hours after completion of treatment #3
860601|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
860602|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
860603|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
860604|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment #2|Subject reported headache 48 hours after completion of treatment #2
860605|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
860606|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported headache 24 hours after completion of treatment #2
860607|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported headache 6 hours after completion of treatment #2
860608|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported headache 6 hours after completion of treatment #2
860609|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments #2 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
860610|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
860611|NCT01200069|O8|Outcome|Pain Score Ibuprofen 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
860612|NCT01200069|O7|Outcome|Pain Score Sugar Water 48 Hours After Treatment 1|Subjects reported headache 48 hours after completion of treatment #1
860614|NCT01200069|O5|Outcome|Pain Score Sugar Water 24 Hours After Treatment #1|Subject reported headache 24 hours after completion of treatment #1
860615|NCT01200069|O4|Outcome|Pain Score Ibuprofen 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
860616|NCT01200069|O3|Outcome|Pain Score After Sugar Water 6 Hours After Treatment #1|Subject reported headache 6 hours after completion of treatment #1
860617|NCT01200069|O2|Outcome|Pain Score Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
860618|NCT01200069|O1|Outcome|Pain Score Sugar Water-one Hour After Treatment 1|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 1"
860619|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
860620|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 3|Subject reported myalgia 48 hours after completion of treatment #3
860621|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
860622|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #3|Subject reported myalgia 24 hours after completion of treatment #3
860623|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #3|Subject reported myalgia 6 hours after completion of treatment #3
860624|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #3|Subject reported myalgia 6 hours after completion of treatment #3
860625|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #3|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 3 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
860626|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 3|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
860627|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
860628|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Treatment 2|Subject reported myalgia 48 hours after completion of treatment #2
860629|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
860630|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #2|Subject reported myalgia 24 hours after completion of treatment #2
860631|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #2|Subject reported myalgia 6 hours after completion of treatment #2
860632|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #2|Subject reported myalgia 6 hours after completion of treatment #2
860633|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #2|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 2 one hour after treatment~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT treatment day 2"
860634|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment 2|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 2~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatment day 2"
860635|NCT01200069|O8|Outcome|Ibuprofen 48 Hours After Treatment 1|subject reported myalgia 48 hours after treatment day 1
860636|NCT01200069|O7|Outcome|Sugar Water 48 Hours After Procedure 1|subject reported myalgia 48 hours after procedure 1
860637|NCT01200069|O6|Outcome|Ibuprofen 24 Hours After Treatment 1|subject reported myalgia 24 hours after procedure 1
860638|NCT01200069|O5|Outcome|Sugar Water 24 Hours After Treatment #1|subject reported myalgia 24 hours after completion of procedure 1
860639|NCT01200069|O4|Outcome|Ibuprofen 6 Hours After Treatment #1|subject reported myalgia 6 hours after treatment 1
860640|NCT01200069|O3|Outcome|Sugar Water 6 Hours After Procedure #1|Subject reported myalgia 6 hours after completion of treatment # 1,
860641|NCT01200069|O2|Outcome|Ibuprofen One Hour After Treatment #1|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~subject report of myalgia one hour after completion of procedure number 1"
860642|NCT01200069|O1|Outcome|Sugar Water-one Hour After Treatment #1|500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatment 1, at one hour following procedure
860643|NCT01200069|E2|Reported Event|Ibuprofen|"800mg/8mL of intravenous ibuprofen over 30 min in 500mL of ringers lactate to be administered prior to ECT for treatments # 1, 2 and 3~ibuprofen intravenous: IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3"
860644|NCT01200069|E1|Reported Event|Sugar Water|"500 mL of ringers lactate over 30 minutes to be administered prior to ECT for treatments 1,2 and 3~Placebo infusion: Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3"
860645|NCT01199965|B3|Baseline|Total|Total of all reporting groups
860646|NCT01199965|B2|Baseline|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
860647|NCT01199965|B1|Baseline|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
860648|NCT01199965|P2|Participant Flow|Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening.
860649|NCT01199965|P1|Participant Flow|Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result.
860650|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at Visit 2 or 3.
860651|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at Visit 2 or 3.
861351|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
860652|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at Visit 2 or 3.
860653|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at Visit 2 or 3.
860654|NCT01199965|O4|Outcome|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
860655|NCT01199965|O3|Outcome|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
860656|NCT01199965|O2|Outcome|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
860657|NCT01199965|O1|Outcome|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
860658|NCT01199965|E4|Reported Event|IV DHE 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving IV DHE at either Visit 2 or 3.
860659|NCT01199965|E3|Reported Event|IV DHE 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving IV DHE at either Visit 2 or 3.
860660|NCT01199965|E2|Reported Event|MAP0004 1.0mg Non-smokers|Never smoked or total exposure <1 pack year and at least 12 months since last cigarette with a negative urinary cotinine result at screening and receiving MAP0004 at either Visit 2 or 3.
860661|NCT01199965|E1|Reported Event|MAP0004 1.0mg Smokers|Currently smoking at least 10 cigarettes/day for at least 1 year with a positive urinary cotinine result and receiving MAP0004 at either Visit 2 or 3.
860662|NCT01199939|B1|Baseline|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860663|NCT01199939|P1|Participant Flow|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860664|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860665|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860666|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860667|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860668|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860669|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860670|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860671|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860672|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860673|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860674|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860675|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860676|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
879071|NCT01150760|B3|Baseline|Total|Total of all reporting groups
860677|NCT01199939|O1|Outcome|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860678|NCT01199939|E1|Reported Event|ETR + DRV/Rtv|Etravirine (ETR) 400mg + Darunavir (DRV) 800mg/Ritonavir (rtv) 100mg once daily orally for 48 weeks
860679|NCT01199926|B3|Baseline|Total|Total of all reporting groups
860680|NCT01199926|B2|Baseline|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
860681|NCT01199926|B1|Baseline|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
860682|NCT01199926|P2|Participant Flow|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
860683|NCT01199926|P1|Participant Flow|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
860684|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
860685|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
860686|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
860687|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
860688|NCT01199926|O2|Outcome|Placebo|Participants in this arm consumed a placebo (microcrystalline cellulose) daily for 12 weeks while participating in a resistance exercise training program.
860689|NCT01199926|O1|Outcome|Vitamin D|Participants in this arm consumed a 4000 IU vitamin D3 supplement daily for 12 weeks while participating in a resistance exercise training program.
861229|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
860690|NCT01199926|E2|Reported Event|Placebo|Were asked to consume a placebo pill (microcrystalline cellulose) each day for 3 months while performing a resistance training intervention.
860691|NCT01199926|E1|Reported Event|Vitamin D|Were asked to consume 4000 IU of vitamin D/day for 3 months while performing a resistance training intervention.
860692|NCT01199861|B3|Baseline|Total|Total of all reporting groups
860693|NCT01199861|B2|Baseline|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860694|NCT01199861|B1|Baseline|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860695|NCT01199861|P2|Participant Flow|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860696|NCT01199861|P1|Participant Flow|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860697|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860698|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860699|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860700|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860701|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860702|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860703|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860704|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860705|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860706|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860707|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860708|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860709|NCT01199861|O2|Outcome|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860710|NCT01199861|O1|Outcome|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
880514|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
860711|NCT01199861|E2|Reported Event|Placebo|Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860712|NCT01199861|E1|Reported Event|Fingolimod|Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
860713|NCT01199822|B4|Baseline|Total|Total of all reporting groups
860714|NCT01199822|B3|Baseline|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860715|NCT01199822|B2|Baseline|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860716|NCT01199822|B1|Baseline|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860717|NCT01199822|P3|Participant Flow|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860718|NCT01199822|P2|Participant Flow|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860719|NCT01199822|P1|Participant Flow|10 mg/kg Olaratumab (IMC-3G3)|10 milligrams/kilogram (mg/kg) olaratumab intravenously (IV) administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of progressive disease (PD), or until other withdrawal criteria were met.
860720|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
861342|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861343|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
860721|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860722|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860723|NCT01199822|O1|Outcome|Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met. 15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860724|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860725|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
860726|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860727|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860728|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
860729|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860730|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860731|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
860732|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860733|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860734|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
860735|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860736|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860737|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycles 1 and 2.
860738|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycles 1 and 2.
860739|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
860740|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle) during Cycle 1.
860741|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle) during Cycle 1.
860742|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860743|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860744|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860745|NCT01199822|O3|Outcome|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860746|NCT01199822|O2|Outcome|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860747|NCT01199822|O1|Outcome|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860748|NCT01199822|E3|Reported Event|15 mg/kg Olaratumab|15 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860749|NCT01199822|E2|Reported Event|20 mg/kg Olaratumab|20 mg/kg olaratumab IV administered on Day 1 every 2 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860750|NCT01199822|E1|Reported Event|10 mg/kg Olaratumab|10 mg/kg olaratumab IV administered on Days 1 and 8, every 3 weeks (6-week cycle). Cycles repeated until there was evidence of PD, or until other withdrawal criteria were met.
860751|NCT01199744|B1|Baseline|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860752|NCT01199744|P1|Participant Flow|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860753|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860754|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860755|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860756|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860757|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860758|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860759|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860760|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860761|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860762|NCT01199744|O1|Outcome|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860763|NCT01199744|E1|Reported Event|Relenza|Dose and frequency of dosing was based on prescribing information. Treatment dose: 10 milligrams (mg) twice daily for 10 days. Prophylactic dose: 10 mg once daily for 10 days.
860764|NCT01199705|B1|Baseline|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
860765|NCT01199705|P1|Participant Flow|IgPro20|Immune Globulin Subcutaneous (Human): IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous use. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
860766|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
860767|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
860768|NCT01199705|O2|Outcome|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
860769|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
860770|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
860771|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
860772|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
860773|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
860774|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
860775|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
860776|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
860777|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
861174|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
860778|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
860779|NCT01199705|O3|Outcome|SCIG IgPro20 Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period.
860780|NCT01199705|O2|Outcome|SCIG IgPro20 Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period.
860781|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
860782|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
860783|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
860784|NCT01199705|O1|Outcome|IVIG Treatment|Subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
860785|NCT01199705|O3|Outcome|SCIG Treatment (Efficacy)|Weekly SC IgPro20 infusions for a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
860786|NCT01199705|O2|Outcome|SCIG Treatment (Wash-in/Wash-out)|Weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG therapy.
860787|NCT01199705|O1|Outcome|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks).
860788|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the efficacy period who had the disease under study.
861432|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
860789|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
860790|NCT01199705|O2|Outcome|IgPro20 - Full Analysis Set (FAS)|The FAS comprised all subjects treated with IgPro20 during the SCIG efficacy period (weeks 13 to 24) who had the disease under study.
860791|NCT01199705|O1|Outcome|IgPro20 - Per Protocol Set (PPS)|The PPS data set comprised all subjects with the disease under study who fulfilled the protocol-specified criteria for a) uniformly repeated immunoglobulin treatment prior to and during the study, b) availability of evaluable serum IgG levels, and c) dose stability.
860792|NCT01199705|E2|Reported Event|SCIG Treatment|IgPro20 was administered subcutaneously with the first SC IgPro20 infusion starting 1 week after the last IVIG dose. Subjects were treated with weekly SC IgPro20 infusions for a 12-week wash-in/wash-out period followed by a 12-week efficacy period. The IgPro20 dose was to be equal to the weekly equivalent dose of the previous IVIG IgG treatment.
860793|NCT01199705|E1|Reported Event|IVIG Treatment|Study subjects were treated with their IVIG therapy with 3- or 4-weekly schedules for 3 dosing cycles (9 to 12 weeks; before being switched to SCIG treatment with IgPro20).
860794|NCT01199601|B3|Baseline|Total|Total of all reporting groups
860795|NCT01199601|B2|Baseline|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention group).~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
860796|NCT01199601|B1|Baseline|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers (control group) .~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling."
860797|NCT01199601|P2|Participant Flow|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider (intervention)~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
860798|NCT01199601|P1|Participant Flow|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from existing hospital providers of same professional cadre as intervention group.~Intrapartum, postpartum counseling : Intrapartum testing and routine counseling package provided by study."
860799|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
860800|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
860801|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
860802|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
860803|NCT01199601|O2|Outcome|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
860804|NCT01199601|O1|Outcome|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
860805|NCT01199601|E2|Reported Event|Counseling, Retrained Provider|"Women randomized to receiving intra-partum testing and concentrated counseling from the retrained provider~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling from a retrained provider"
860828|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860806|NCT01199601|E1|Reported Event|Counseling Existing Providers|"Women receiving intra-partum testing and the usual post-partum counseling from re-trained hospital providers of same professional cadre as control group.~Intrapartum, postpartum counseling : Intrapartum testing and concentrated counseling package provided by study."
860807|NCT01199471|B1|Baseline|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860808|NCT01199471|P1|Participant Flow|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860809|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860855|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
861433|NCT01197755|E3|Reported Event|PLACEBO PO|Dosing Group C
860810|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860811|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860812|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860813|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860814|NCT01199471|O1|Outcome|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 through 3, who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA).
860815|NCT01199471|E1|Reported Event|Chinese Patients Requiring Surgery With Anesthesia|Chinese patients 18 to 70 years of age, meeting the American Society of Anesthesiologists (ASA) Physical Status Class 1 (normal healthy), Class 2 (mild systemic disease), or Class 3 (severe systemic disease), who underwent surgery requiring general anesthesia administered per the local Prescribing Information and endotracheal intubation or laryngeal mask airway (LMA). Note, 3 patients were excluded from all analyses who did not meet ASA Physical Status Class 1 through 3.
860816|NCT01199237|B3|Baseline|Total|Total of all reporting groups
860817|NCT01199237|B2|Baseline|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
860818|NCT01199237|B1|Baseline|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
860819|NCT01199237|P2|Participant Flow|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
860820|NCT01199237|P1|Participant Flow|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
860821|NCT01199237|O2|Outcome|Desflurane|Patients received Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
860822|NCT01199237|O1|Outcome|Sevoflurane|Patients received sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)
860823|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860824|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860825|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860826|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860827|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
880515|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
860829|NCT01199237|O2|Outcome|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860830|NCT01199237|O1|Outcome|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860831|NCT01199237|E2|Reported Event|Desflurane|"Patients receive Desflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Desflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860832|NCT01199237|E1|Reported Event|Sevoflurane|"Patients receive sevoflurane, rocuronium with neostigmine + glycopyrrolate reversal (70 and 14 ug/kg)~Sevoflurane: Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water"
860833|NCT01199042|B1|Baseline|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Diagnostic, then CPAP, then BiPAP autoSV Advanced (within-subjects design)
860834|NCT01199042|P1|Participant Flow|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
860856|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
861344|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
860835|NCT01199042|O1|Outcome|Diagnostic, Continuous Positive Airway Pressure (CPAP), ASV|All participants first underwent a full night, attended diagnostic PSG. Eligible participants then had an attended full night Continuous Positive Airway Pressure (CPAP) manual titration followed by full night, attended, but automated titration with the BiPAP automatic Servo Ventilation.(AutoSV) Advanced™ (Philips Respironics, Murrysville, PA), device.
860836|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|"Positive airway pressure device~BiPAP autoSV Advanced: The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night."
860837|NCT01199042|O1|Outcome|BiPAP autoSV Advanced Device|Over the 90-day home treatment period, the Auto-Servo Ventilation (ASV) device consistently treated obstructive and central Sleep Disordered Breathing (SDB) events.
860838|NCT01199042|O3|Outcome|BiPAP autoSV Apnea-Hypopnea Index|The BiPAP autoSV machine was used to determine the Apnea-Hypopnea Index
860839|NCT01199042|O2|Outcome|Continuous Positive Airway Pressure Apnea-Hypopnea Index|The CPAP machine was used to determine the Apnea-Hypopnea Index.
860840|NCT01199042|O1|Outcome|Diagnostic Apnea-Hypopnea Index|Participants had Diagnostic PSG where the Apnea-Hypopnea Index was measured
860841|NCT01199042|E1|Reported Event|Diagnostic, Then CPAP, Then BiPAP autoSV Advanced|Participants had a diagnostic PSG, then CPAP and BiPAP autoSV. Participants then went home and used the autoSV for 90 days.
860842|NCT01199016|B1|Baseline|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
860843|NCT01199016|P1|Participant Flow|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
860844|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
860845|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
860846|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
860847|NCT01199016|O1|Outcome|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
860891|NCT01198769|E1|Reported Event|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860892|NCT01198756|B5|Baseline|Total|Total of all reporting groups
860914|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860848|NCT01199016|E1|Reported Event|Prevnar 13|Participants who were 6 to 12 months of age and had completed immunization schedule of the Prevnar 13 infant series or participants who were up to 30 months of age and met the criteria for recurrent acute otitis media (AOM) were enrolled. Recurrent AOM was defined as greater than or equal to (>=)3 distinct episodes in a 6-month period or >=4 distinct episodes in a 12-month period. Participants who were diagnosed with AOM, underwent both nasopharyngeal/oropharyngeal (NP/OP) swab and diagnostic tympanocentesis (or collection of MEF via swab if tympanocentesis could not be performed).
860849|NCT01198977|B3|Baseline|Total|Total of all reporting groups
860850|NCT01198977|B2|Baseline|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
860851|NCT01198977|B1|Baseline|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
860852|NCT01198977|P2|Participant Flow|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
860853|NCT01198977|P1|Participant Flow|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
860854|NCT01198977|O2|Outcome|Education Counseling|"Exercise information and instructional video~Informational video: Mailed video of exercise programs"
860857|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
860858|NCT01198977|O2|Outcome|Education Counseling|"Self-directed physical activity information and instructional video~Informational video: Mailed video of Physical activity programs"
860859|NCT01198977|O1|Outcome|Telephone Counseling|"Telephone based counseling and instructional video~Intervention of brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
860860|NCT01198977|E2|Reported Event|Education Counseling|"Exercise information and instructional video (Control)~Informational video: Mailed video of exercise programs"
860861|NCT01198977|E1|Reported Event|Telephone Counseling|"Telephone based counseling and instructional video (Intervention)~Brief telephone-based counseling: Motivational interviewing and exercise goal setting and problem solving"
860862|NCT01198873|B3|Baseline|Total|Total of all reporting groups
860863|NCT01198873|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860864|NCT01198873|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860865|NCT01198873|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860866|NCT01198873|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860867|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860868|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860869|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860870|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860871|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860872|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860873|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860874|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860875|NCT01198873|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860876|NCT01198873|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860877|NCT01198873|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day (average treatment duration of approximatively 6 months)
860878|NCT01198873|E1|Reported Event|Placebo|Placebo (for Dronedarone) twice a day (average treatment duration of approximatively 6 months)
860879|NCT01198795|B1|Baseline|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
860880|NCT01198795|P1|Participant Flow|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
860881|NCT01198795|O1|Outcome|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
860882|NCT01198795|E1|Reported Event|Escitalopram|Flexible-dose 10mg-20mg once-daily oral (10mg tablets) dose of escitalopram for 24-weeks, with a 2-week downtaper period.
860883|NCT01198769|B1|Baseline|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860884|NCT01198769|P1|Participant Flow|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860885|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860886|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860887|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860888|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860889|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
860890|NCT01198769|O1|Outcome|Rotarix Group|subjects received 2 oral doses of Rotarix™ vaccine at 2 and 4 months of age.
880516|NCT01147406|E6|Reported Event|Placebo|Not Active - Placebo
860893|NCT01198756|B4|Baseline|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860894|NCT01198756|B3|Baseline|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860895|NCT01198756|B2|Baseline|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860896|NCT01198756|B1|Baseline|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860897|NCT01198756|P4|Participant Flow|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
861088|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
860898|NCT01198756|P3|Participant Flow|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860899|NCT01198756|P2|Participant Flow|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860900|NCT01198756|P1|Participant Flow|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860901|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860902|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860903|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860904|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860905|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860906|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860907|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860908|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860909|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860910|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860911|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860912|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860913|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
861319|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
860915|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860916|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860917|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860918|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860919|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860920|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860921|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860922|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860923|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860924|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860925|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860926|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860927|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860928|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860929|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860930|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860931|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860932|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860933|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860934|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860935|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860978|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860936|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860937|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860938|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860939|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860940|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860941|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860942|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860943|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860944|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860945|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860946|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860947|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860948|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860949|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860950|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860951|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860952|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860953|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860954|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860955|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860956|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861217|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
860957|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860958|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860959|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860960|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861008|NCT01198691|E2|Reported Event|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
860961|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860962|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860963|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860964|NCT01198756|O7|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860965|NCT01198756|O6|Outcome|Yamagata Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860966|NCT01198756|O5|Outcome|Yamagata Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860967|NCT01198756|O4|Outcome|Victoria Strain Fluarix (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860968|NCT01198756|O3|Outcome|Victoria Strain Fluarix (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860969|NCT01198756|O2|Outcome|GSK2282512A 1 (9-17 Years) Group|Subjects, 9 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860970|NCT01198756|O1|Outcome|GSK2282512A 1 (3-8 Years) Group|Subjects, 3 to 8 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860971|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860972|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860973|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860974|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860975|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860976|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860977|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860979|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860980|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860981|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860982|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861226|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
860983|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860984|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860985|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860986|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860987|NCT01198756|O4|Outcome|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860988|NCT01198756|O3|Outcome|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860989|NCT01198756|O2|Outcome|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860990|NCT01198756|O1|Outcome|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860991|NCT01198756|E4|Reported Event|GSK2282512A 2 Group|Subjects, 6 to 35 months old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm for subjects ≥12 months of age and into the antero-lateral region of the left thigh for infants <12 months of age.
860992|NCT01198756|E3|Reported Event|Yamagata Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ YB vaccine containing the Yamagata lineage B flu strain at Day 0 or 2 doses of Fluarix™ YB vaccine at Day 0 and Day 28. The Fluarix™ YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860993|NCT01198756|E2|Reported Event|Victoria Strain Fluarix Group|Subjects, 3 to 17 years old, received 1 dose of Fluarix™ VB vaccine containing the Victoria lineage B flu strain at Day 0 or 2 doses of Fluarix™ VB vaccine at Day 0 and Day 28. The Fluarix™ VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860994|NCT01198756|E1|Reported Event|GSK2282512A 1 Group|Subjects, 3 to 17 years old, received 1 dose of GSK2282512A vaccine at Day 0 or 2 doses of GSK2282512A vaccine at Day 0 and Day 28. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
860995|NCT01198691|B3|Baseline|Total|Total of all reporting groups
860996|NCT01198691|B2|Baseline|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
860997|NCT01198691|B1|Baseline|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
860998|NCT01198691|P2|Participant Flow|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
860999|NCT01198691|P1|Participant Flow|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
861000|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
861001|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
861002|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
861003|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
861004|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
861005|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
861006|NCT01198691|O2|Outcome|Case Group|"This group will receive the Insorb absorbable staples to close their incision.~Insorb: Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples"
861007|NCT01198691|O1|Outcome|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
861345|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861009|NCT01198691|E1|Reported Event|Control Group|"This group will receive the standard metallic staples to close their incision.~Insorb absorbable staples: Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples"
861010|NCT01198600|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
861011|NCT01198600|P4|Participant Flow|Phase 3: Lotrafilcon B Replacement Replacement|Contact lenses worn for 43 days with replacement pair dispensed on Day 1 and Day 28.
861012|NCT01198600|P3|Participant Flow|Phase 2: Lotrafilcon B Replacement|Contact lenses worn for 56 days with replacement pair dispensed at Day 28.
861013|NCT01198600|P2|Participant Flow|Phase 1: Habitual Replacement, Then Habitual no Replacement|Contact lenses per participant's habitual prescription worn for 30 days with a new pair dispensed at Day 28, followed by contact lenses per habitual prescription worn for 30 days with no replacement.
861014|NCT01198600|P1|Participant Flow|Phase 1: Habitual no Replacement, Then Habitual Replacement|Contact lenses per participant's habitual prescription worn for 30 days with no replacement, followed by contact lenses per habitual prescription worn for 30 days with a new pair dispensed at Day 28.
861015|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861016|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861017|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861018|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861019|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861020|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861021|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861022|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861023|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861024|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861025|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2.of Phase 2."
861026|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861027|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861028|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861029|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861030|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861031|NCT01198600|O2|Outcome|Strugglers: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days during Phase 3, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15. Strugglers were participants who reported a reduction in subjective comfort of at least 15 points on a 100-point scale between Day 1 and Day 27 of Phase 2."
861227|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861032|NCT01198600|O1|Outcome|Survivors: Lotrafilcon B/Replacement/Replacement|"Contact lenses worn for 43 days, with initial dispense on Day 0 and subsequent dispenses on Days 1 and 15 during Phase 3. Survivors were participants who reported no or very little reduction in subjective comfort between Day 1 and Day 27 of Phase 2."
861033|NCT01198600|E2|Reported Event|Lotrafilcon B Contact Lens|Contact lens worn for 56 days with a replacement dispensed at Day 28 in Phase 2, followed by 43 days in Phase 3 with a replacement dispensed at Day 1 and Day 14.
861034|NCT01198600|E1|Reported Event|Habitual Contact Lens|Contact lens per participant's habitual prescription worn for two 30-day periods in Phase 1, with a replacement dispensed at Day 28 in either Period 1 or Period 2.
861035|NCT01198574|B5|Baseline|Total|Total of all reporting groups
861036|NCT01198574|B4|Baseline|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
861037|NCT01198574|B3|Baseline|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
861038|NCT01198574|B2|Baseline|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
861039|NCT01198574|B1|Baseline|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
861040|NCT01198574|P4|Participant Flow|Placebo Group|Placebo group received 2.5 mg folic acid weekly
861041|NCT01198574|P3|Participant Flow|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid + 15,000 IU Vitamin A weekly
861042|NCT01198574|P2|Participant Flow|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Placebo iron containing 2.5 mg folic acid weekly
861043|NCT01198574|P1|Participant Flow|Iron Group|Iron group received 60 mg of elemental iron, 2.5 mg folic acid + Placebo Vitamin A weekly
861044|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
861045|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
861046|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
861047|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
861048|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
861049|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
861050|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
861051|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
861052|NCT01198574|O4|Outcome|Placebo Group|2.5 mg folic acid + Vitamin A placebo
861053|NCT01198574|O3|Outcome|Iron and Vitamin A Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A 15,000 IU
861054|NCT01198574|O2|Outcome|Vitamin A Group|15,000 IU vitamin A + Iron Placebo containing 2.5 mg folic acid
861055|NCT01198574|O1|Outcome|Iron Group|60 mg Elemental iron with 2.5 mg folic acid + Vitamin A placebo
861056|NCT01198574|E4|Reported Event|Placebo Group|Placebo group received iron placebo containing 2.5 mg folic acid weekly
861057|NCT01198574|E3|Reported Event|Iron and Vitamin A Group|Iron and Vitamin A group received 60 mg elemental iron, 2.5 mg folic acid +15,000 IU Vitamin A weekly
861058|NCT01198574|E2|Reported Event|Vitamin A Group|Vitamin A group received 15,000 IU Vitamin A + Iron placebo with 2.5 mg folic acid weekly
861059|NCT01198574|E1|Reported Event|Iron Group|Iron group received 60 mg elemental iron, 2.5 mg folic acid with vitamin A placebo weekly
861060|NCT01198548|B1|Baseline|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861061|NCT01198548|P1|Participant Flow|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861062|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861063|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861064|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861228|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861065|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861066|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861067|NCT01198548|O1|Outcome|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861068|NCT01198548|E1|Reported Event|Treatment (FOLXFOX, Bevacizumab, Cholecalciferol)|"Patients receive high-dose cholecalciferol once daily. Patients also receive bevacizumab IV over 10 minutes, leucovorin calcium IV over 2 hours, oxaliplatin* IV over 2 hours, and fluorouracil IV continuously over 46 hours once a week. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. NOTE: *Treatment with oxaliplatin is discontinued after course 8~leucovorin calcium: Given IV~bevacizumab: Given IV~cholecalciferol: Given PO~fluorouracil: Given IV~oxaliplatin: Given IV~pharmacological study: Correlative studies"
861069|NCT01198509|B7|Baseline|Total|Total of all reporting groups
861070|NCT01198509|B6|Baseline|Healthy Volunteers|Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
861071|NCT01198509|B5|Baseline|Psoriatic Arthritis (PsA)|Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.
861072|NCT01198509|B4|Baseline|Early RA Cross-sectional Cohort|Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).
861073|NCT01198509|B3|Baseline|Rheumatoid Arthritis (RA) Randomized to no Treatment|Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.
861074|NCT01198509|B2|Baseline|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
861075|NCT01198509|B1|Baseline|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
861076|NCT01198509|P6|Participant Flow|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
861077|NCT01198509|P5|Participant Flow|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
861078|NCT01198509|P4|Participant Flow|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
861079|NCT01198509|P3|Participant Flow|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
861080|NCT01198509|P2|Participant Flow|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks~N=10 (actual)"
861081|NCT01198509|P1|Participant Flow|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months~N=5 (actual)"
861082|NCT01198509|O6|Outcome|Healthy Volunteers|"Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=58 (actual)"
861083|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
861084|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
861085|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment and followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
861086|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
861087|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
861089|NCT01198509|O5|Outcome|Psoriatic Arthritis (PsA)|"Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~N=20 (actual)"
861090|NCT01198509|O4|Outcome|Early RA Cross-sectional Cohort|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria who opted to participate ONLY in cross-sectional analysis (one-time sample collection equivalent to the involvement of PsA and health control subjects).~N=66 (actual)"
861091|NCT01198509|O3|Outcome|Rheumatoid Arthritis (RA) Randomized to no Treatment|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment, followed prospectively for 6 months, for comparison with Doxycycline- and Vancomycin-treated patients.~N=19 (actual)"
861092|NCT01198509|O2|Outcome|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
861093|NCT01198509|O1|Outcome|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
861094|NCT01198509|E3|Reported Event|RA, PsA, Healthy|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive no antibiotic treatment for comparison with Doxycycline- and Vancomycin-treated patients.~Patients with psoriatic arthritis (PsA), to provide baseline samples of oral and intestinal microbiota for comparison with RA patients.~Healthy individuals with no history of arthritis, to provide baseline samples of oral and intestinal microbiota for comparison with RA patients."
861095|NCT01198509|E2|Reported Event|Rheumatoid Arthritis (RA) - Vancomycin|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive vancomycin, 250 mg four times a day, for 2 weeks~vancomycin: vancomycin, 250 mg four times a day, for 2 weeks"
861096|NCT01198509|E1|Reported Event|Rheumatoid Arthritis (RA) - Doxycycline|"Patients with rheumatoid arthritis (RA) meeting inclusion criteria, randomized to receive doxycycline, 100 mg twice a day, for 2 months.~doxycycline: doxycycline - 100 mg twice per day, for 2 months"
861097|NCT01198366|B7|Baseline|Total|Total of all reporting groups
861098|NCT01198366|B6|Baseline|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
861099|NCT01198366|B5|Baseline|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861100|NCT01198366|B4|Baseline|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861101|NCT01198366|B3|Baseline|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861102|NCT01198366|B2|Baseline|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861103|NCT01198366|B1|Baseline|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
861104|NCT01198366|P6|Participant Flow|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
861105|NCT01198366|P5|Participant Flow|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861106|NCT01198366|P4|Participant Flow|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861107|NCT01198366|P3|Participant Flow|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861108|NCT01198366|P2|Participant Flow|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861173|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861109|NCT01198366|P1|Participant Flow|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
861110|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
861111|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861112|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861113|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861114|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861115|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
861116|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
861117|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861118|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861119|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861120|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861121|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
861122|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
861123|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861124|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861125|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861126|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861127|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
861128|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
861129|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861130|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861131|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861132|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861133|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
861134|NCT01198366|O6|Outcome|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo on days 0, 28 and 280.~Placebo: Sterile buffer"
861469|NCT01197534|B4|Baseline|Total|Total of all reporting groups
861135|NCT01198366|O5|Outcome|Expanded Safety Phase - Group 5|"Subjects received 3 doses of AERAS-402 (1 X 10^11 vp) on days 0, 28 and 280.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861136|NCT01198366|O4|Outcome|Dose Finding - Group 4|"Subjects enrolled in Study Group 4 will receive two doses of AERAS-402 (1.0 x 10^11 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.0 x 10^11 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861137|NCT01198366|O3|Outcome|Dose Finding - Group 3|"Subjects enrolled in Study Group 3 will receive two doses of AERAS-402 (3.0 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 3.0 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861138|NCT01198366|O2|Outcome|Dose Finding - Group 2|"Subjects enrolled in Study Group 2 will receive two doses of AERAS-402 (1.5 x 10^10 vp) once on Study Day 0 and again on Study Day 28.~AERAS-402 1.5 x 10^10 vp: Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of three Mycobacterium tuberculosis antigens."
861139|NCT01198366|O1|Outcome|Dose Finding - Group 1|"Subjects enrolled in Study Group 1 will receive two doses of placebo once on Study Day 0 and again on Study Day 28.~Placebo: Sterile buffer"
861140|NCT01198366|E6|Reported Event|Expanded Safety Phase - Group 5 Placebo|"Subjects received 3 doses of placebo (sterile buffer) on days 0, 28 and 280.~Placebo"
861141|NCT01198366|E5|Reported Event|Expanded Safety Phase - Group 5|Subjects received 3 doses of AERAS-402 (1.0 X 10^11 vp) on days 0, 28 and 280.
861142|NCT01198366|E4|Reported Event|Dose Finding - Group 4|Subjects received two doses of AERAS-402 (1.0 x 10^11 vp) on study days 0 and 28.
861143|NCT01198366|E3|Reported Event|Dose Finding - Group 3|Subjects received two doses of AERAS-402 (3.0 x 10^10 vp) on study days 0 and 28.
861144|NCT01198366|E2|Reported Event|Dose Finding - Group 2|Subjects received two doses of AERAS-402 (1.5 x 10^10 vp) on study days 0 and 28.
861145|NCT01198366|E1|Reported Event|Dose Finding - Group 1|Subjects received two doses of placebo (sterile buffer) on study days 0 and 28.
861146|NCT01198327|B1|Baseline|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
861147|NCT01198327|P1|Participant Flow|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
861148|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
861149|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for central retinal vein occlusion.
861150|NCT01198327|O2|Outcome|Ranibizumab as Needed -BRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. BRVO stands for branch retinal vein occlusion.
861151|NCT01198327|O1|Outcome|Ranibizumab as Needed -CRVO|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion. CRVO stands for Central retinal vein occlusion.
861152|NCT01198327|O1|Outcome|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
861153|NCT01198327|E1|Reported Event|Ranibizumab as Needed|Ranibizumab as needed, with optional peripheral laser to areas of non-perfusion.
861154|NCT01198275|B3|Baseline|Total|Total of all reporting groups
861155|NCT01198275|B2|Baseline|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
861156|NCT01198275|B1|Baseline|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
861157|NCT01198275|P2|Participant Flow|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
861158|NCT01198275|P1|Participant Flow|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
861159|NCT01198275|O2|Outcome|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
861160|NCT01198275|O1|Outcome|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
861161|NCT01198275|E2|Reported Event|Placebo|1.0 g placebo gelatine capsules(olive oil)twice daily
861162|NCT01198275|E1|Reported Event|n-3 PUFAs|1.0 g gelatin capsules containing a total of 850 mg to 882 mg of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) ethyl esters with an average ratio EPA/DHA of 0.9:1.5 twice daily
861163|NCT01198145|B3|Baseline|Total|Total of all reporting groups
861164|NCT01198145|B2|Baseline|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy. >~> placebo: Given orally"
861165|NCT01198145|B1|Baseline|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861166|NCT01198145|P2|Participant Flow|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.~>~> placebo: Given orally"
861167|NCT01198145|P1|Participant Flow|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861168|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861169|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861170|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861171|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861172|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
880517|NCT01147406|E5|Reported Event|Cohort 6|N6022 - Active 35 mg
861175|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861176|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861177|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861178|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861179|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861180|NCT01198145|O2|Outcome|Arm II: Placebo|Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861181|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861182|NCT01198145|O2|Outcome|Arm II: Placebo|"Patients receive two oral placebo tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.~>~> placebo: Given orally"
861183|NCT01198145|O1|Outcome|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861184|NCT01198145|E2|Reported Event|Arm II: Placebo|placebo: Given orally
861185|NCT01198145|E1|Reported Event|Arm I: Sulfasalazine|Patients receive two 500 mg oral sulfasalazine tablets twice daily during radiotherapy and for 4 weeks after completion of radiotherapy.
861186|NCT01197911|B4|Baseline|Total|Total of all reporting groups
861187|NCT01197911|B3|Baseline|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861188|NCT01197911|B2|Baseline|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861189|NCT01197911|B1|Baseline|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861190|NCT01197911|P3|Participant Flow|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861191|NCT01197911|P2|Participant Flow|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861192|NCT01197911|P1|Participant Flow|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861193|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861194|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861195|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861196|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861197|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861198|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861199|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861200|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861201|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861202|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861203|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861204|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861205|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861206|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861207|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861208|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861209|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861210|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861211|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861212|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861213|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861214|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861215|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861216|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861316|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861218|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861219|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861220|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861221|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861222|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861223|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861224|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861225|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861230|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861231|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861232|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861233|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861234|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861235|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861236|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861237|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861238|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861239|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861240|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861241|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861242|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861243|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861244|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861245|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861246|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861247|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861248|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861249|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861250|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861251|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861252|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861253|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861254|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861255|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861256|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861257|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861258|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861259|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861260|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861261|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861262|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861263|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861264|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 mcg tablet
861265|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861266|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861267|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861268|NCT01197911|O3|Outcome|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861269|NCT01197911|O2|Outcome|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861270|NCT01197911|O1|Outcome|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861271|NCT01197911|E3|Reported Event|Moderate Hepatic Impairment|Participants with moderate hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861272|NCT01197911|E2|Reported Event|Mild Hepatic Impairment|Participants with mild hepatic impairment received a single oral dose of aleglitazar 150 mcg tablet
861273|NCT01197911|E1|Reported Event|Normal Hepatic Function|Participants with normal hepatic function received a single oral dose of aleglitazar 150 microgram (mcg) tablet
861274|NCT01197898|B3|Baseline|Total|Total of all reporting groups
861275|NCT01197898|B2|Baseline|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
861276|NCT01197898|B1|Baseline|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
861277|NCT01197898|P2|Participant Flow|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
861278|NCT01197898|P1|Participant Flow|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
861279|NCT01197898|O2|Outcome|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
861280|NCT01197898|O1|Outcome|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
861281|NCT01197898|E2|Reported Event|Vehicle Base|"Applied once daily~Placebo Comparator : Topical daily application"
861282|NCT01197898|E1|Reported Event|Collagenase Santyl Ointment|"Applied once daily~Collagenase Santyl Ointment : Topical daily application"
861283|NCT01197833|B4|Baseline|Total|Total of all reporting groups
861284|NCT01197833|B3|Baseline|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
861285|NCT01197833|B2|Baseline|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
861286|NCT01197833|B1|Baseline|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
861287|NCT01197833|P3|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
861288|NCT01197833|P2|Participant Flow|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
861289|NCT01197833|P1|Participant Flow|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
861290|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
861291|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
861292|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
861293|NCT01197833|O3|Outcome|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
861294|NCT01197833|O2|Outcome|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
861295|NCT01197833|O1|Outcome|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
861296|NCT01197833|E3|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam 1.0%|endovenous ablation followed by polidocanol injectable foam 1.0%
861297|NCT01197833|E2|Reported Event|Endovenous Ablation, Polidocanol Injectable Foam, 0.5%|Endovenous ablation followed by polidocanol injectable foam, 0.5%
861298|NCT01197833|E1|Reported Event|Endovenous Ablation, Vehicle Placebo|Endovenous ablation followed by vehicle placebo
861299|NCT01197794|B8|Baseline|Total|Total of all reporting groups
861300|NCT01197794|B7|Baseline|Placebo|Placebo
861301|NCT01197794|B6|Baseline|AZD1981 10 mg|AZD1981 10 mg twice daily
861302|NCT01197794|B5|Baseline|AZD1981 40 mg|AZD1981 40 mg twice daily
861303|NCT01197794|B4|Baseline|AZD1981 80 mg|AZD1981 80 mg once daily
861304|NCT01197794|B3|Baseline|AZD1981 100 mg|AZD1981 100 mg twice daily
861305|NCT01197794|B2|Baseline|AZD1981 200 mg|AZD1981 200 mg once daily
861306|NCT01197794|B1|Baseline|AZD1981 400 mg|AZD1981 400 mg twice daily
861307|NCT01197794|P7|Participant Flow|Placebo|Placebo
861308|NCT01197794|P6|Participant Flow|AZD1981 10 mg|AZD1981 10 mg twice daily
861309|NCT01197794|P5|Participant Flow|AZD1981 40 mg|AZD1981 40 mg twice daily
861310|NCT01197794|P4|Participant Flow|AZD1981 80 mg|AZD1981 80 mg once daily
861311|NCT01197794|P3|Participant Flow|AZD1981 100 mg|AZD1981 100 mg twice daily
861312|NCT01197794|P2|Participant Flow|AZD1981 200 mg|AZD1981 200 mg once daily
861313|NCT01197794|P1|Participant Flow|AZD1981 400 mg|AZD1981 400 mg twice daily
861314|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861315|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861320|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861321|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861322|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861323|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861324|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861325|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861326|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861327|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861328|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861329|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861330|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861331|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861332|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861333|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861334|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861335|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861336|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861337|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861338|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861339|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861340|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861341|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861352|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861353|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861354|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861355|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861356|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861357|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861358|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861359|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861360|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861361|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861362|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861363|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861364|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861365|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861366|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861367|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861368|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861369|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861370|NCT01197794|O7|Outcome|Arm 7-Placebo|Placebo
861371|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861372|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861373|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861374|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861375|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861376|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861377|NCT01197794|O7|Outcome|Arm7-Placebo|Placebo
861378|NCT01197794|O6|Outcome|Arm 6 - AZD1981 10 mg|AZD1981 10 mg twice daily
861379|NCT01197794|O5|Outcome|Arm 5 - AZD1981 40 mg|AZD1981 40 mg twice daily
861380|NCT01197794|O4|Outcome|Arm 4 - AZD1981 80 mg|AZD1981 80 mg once daily
861381|NCT01197794|O3|Outcome|Arm 3 - AZD1981 100 mg|AZD1981 100 mg twice daily
861382|NCT01197794|O2|Outcome|Arm 2 - AZD1981 200 mg|AZD1981 200 mg once daily
861383|NCT01197794|O1|Outcome|Arm 1 - AZD1981 400 mg|AZD1981 400 mg twice daily
861384|NCT01197794|E7|Reported Event|Placebo|Placebo
861385|NCT01197794|E6|Reported Event|AZD1981 10 mg|AZD1981 10 mg twice daily
861386|NCT01197794|E5|Reported Event|AZD1981 40 mg|AZD1981 40 mg twice daily
861387|NCT01197794|E4|Reported Event|AZD1981 80 mg|AZD1981 80 mg once daily
861388|NCT01197794|E3|Reported Event|AZD1981 100 mg|AZD1981 100 mg twice daily
861389|NCT01197794|E2|Reported Event|AZD1981 200 mg|AZD1981 200 mg once daily
861390|NCT01197794|E1|Reported Event|AZD1981 400 mg|AZD1981 400 mg twice daily
861391|NCT01197755|B4|Baseline|Total|Total of all reporting groups
861392|NCT01197755|B3|Baseline|PLACEBO PO|Dosing Group C
861393|NCT01197755|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861394|NCT01197755|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
861395|NCT01197755|P3|Participant Flow|PLACEBO PO|Dosing Group C
861396|NCT01197755|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861397|NCT01197755|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
861398|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861399|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861400|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861401|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861402|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861403|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861404|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861405|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861406|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861407|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861408|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861409|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861410|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861411|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861412|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861413|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861414|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861415|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861416|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861417|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861418|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861419|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861420|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861421|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861422|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861423|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861424|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861425|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861426|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861427|NCT01197755|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861428|NCT01197755|O2|Outcome|Dosing Group A and B Combined PO|Fostamatinib 100 mg BID (combined)
861429|NCT01197755|O1|Outcome|PLACEBO PO|Dosing Group C
861430|NCT01197755|O3|Outcome|PLACEBO PO|Dosing Group C
861431|NCT01197755|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861434|NCT01197755|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861435|NCT01197755|E1|Reported Event|FOSTA 100 MG BID PO|Dosing Group A
861436|NCT01197560|B3|Baseline|Total|Total of all reporting groups
861437|NCT01197560|B2|Baseline|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861438|NCT01197560|B1|Baseline|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861439|NCT01197560|P2|Participant Flow|Investigator's Choice (Control Arm)|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the participant's request and at the investigators' discretion at the same doses mentioned."
861440|NCT01197560|P1|Participant Flow|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861441|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861442|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861470|NCT01197534|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861471|NCT01197534|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861443|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861444|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861445|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861446|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861501|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861502|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861503|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861504|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861447|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861448|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861449|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861450|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861451|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861452|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861472|NCT01197534|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
861473|NCT01197534|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861474|NCT01197534|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861475|NCT01197534|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
861476|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861453|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861454|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861455|NCT01197560|O2|Outcome|Investigator's Choice|"Investigator’s Choice Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861505|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861506|NCT01197534|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861507|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO (Combined)|Dosing Group A and B combined
861508|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861456|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861457|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861458|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861459|NCT01197560|O2|Outcome|Investigator's Choice|"Participants received a single agent reference therapy (either gemcitabine, oxaliplatin, rituximab or etoposide) based on published data for up to 6 cycles or until disease progression, unacceptable toxicity or withdrawal.~Gemcitabine 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 in each 28- day cycle for 6 Cycles~Oxaliplatin 100 mg/m^2 IV day 1 in each 21-day cycle for 6 Cycles~Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide doses:~100 mg/m^2 IV days 1-5 in each 28-day cycle for 6 Cycles, or 100 mg/m^2 IV days 1-3 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-21 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-14 in each 28-day cycle for 6 Cycles, or 50 mg/m^2 oral days 1-10 in each 28-day cycle for 6 Cycles"
861460|NCT01197560|O1|Outcome|Lenalidomide|Lenalidomide 25 mg orally once daily for 21 days in each 28-day cycle until progressive disease. For participants with creatinine clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg once daily for 21 days for 2 cycles. After Cycle 2 the dose may be increased to a maximum of 15 mg lenalidomide once daily for 21 days in each 28-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or voluntary withdrawal.
861461|NCT01197560|E2|Reported Event|Investigator's Choice|"One of the following:~Gemcitabine, Oxaliplatin, Rituximab, or Etoposide~Gemcitabine: Suggested starting doses and regimens for Gemcitabine are 1,250 mg/m^2 Intravenous (IV) days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 every 28 days for 6 Cycles~Oxaliplatin: Suggested starting dose and regimen for Oxaliplatin is 100 mg/m^2 IV day 1 for 21 days for 6 Cycles~Rituximab: Suggested starting dose for Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)~Etoposide: Suggested starting doses for Etoposide are:~100 mg/m^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-10 every 28 days for 6 Cycles"
861462|NCT01197560|E1|Reported Event|Lenalidomide|Lenalidomide: Lenalidomide 25 mg orally for 21 out of every 28 day cycle until progressive disease. For participants with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10mg (maximum dose was 15 mg lenalidomide).
861463|NCT01197547|B1|Baseline|Genesys HTA|"Genesys HTA Endometrial Ablation~Genesys HTA: Genesys HTA Endometrial Ablation"
861464|NCT01197547|P1|Participant Flow|Genesys HTA|Genesys HTA Endometrial Ablation
861465|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
861466|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
861467|NCT01197547|O1|Outcome|Genesys HTA|Genesys HTA Endometrial Ablation
861468|NCT01197547|E1|Reported Event|Genesys HTA|Genesys HTA Endometrial Ablation
861477|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861478|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861479|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861480|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861481|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861482|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861483|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861484|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861485|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861486|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861487|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861488|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861489|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861490|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861491|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861492|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861493|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861494|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861495|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861496|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861497|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861498|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861499|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861500|NCT01197534|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861509|NCT01197534|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861510|NCT01197534|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861511|NCT01197534|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
861512|NCT01197534|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
861513|NCT01197534|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
861514|NCT01197534|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
861515|NCT01197521|B4|Baseline|Total|Total of all reporting groups
861516|NCT01197521|B3|Baseline|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861517|NCT01197521|B2|Baseline|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861518|NCT01197521|B1|Baseline|FOSTA 100 MG BID PO|Dosing Group A
861519|NCT01197521|P3|Participant Flow|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861520|NCT01197521|P2|Participant Flow|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861521|NCT01197521|P1|Participant Flow|FOSTA 100 MG BID PO|Dosing Group A
861522|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861523|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861524|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861525|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861526|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861527|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861528|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861529|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861530|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861531|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861532|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861533|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861534|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861535|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861536|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861537|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861538|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861539|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861540|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861541|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861542|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861543|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861544|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861545|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861546|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861547|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861548|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861549|NCT01197521|O2|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861550|NCT01197521|O1|Outcome|FOSTA 100 MG BID (Combined)|Dosing Group A and B combined
861551|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861552|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861553|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861554|NCT01197521|O3|Outcome|PLACEBO (24 WKS) THEN FOSTA 100 MG BID PO|Dosing Group C
861555|NCT01197521|O2|Outcome|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD PO|Dosing Group B
861556|NCT01197521|O1|Outcome|FOSTA 100 MG BID PO|Dosing Group A
861557|NCT01197521|E4|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - Placebo Period|
861558|NCT01197521|E3|Reported Event|PLACEBO (24 WKS) THEN FOSTA 100 MG BID - FOSTA Period|Dosing Group C
861559|NCT01197521|E2|Reported Event|FOSTA 100 MG BID (4 WKS) THEN 150 MG QD|Dosing Group B
861560|NCT01197521|E1|Reported Event|FOSTA 100 MG BID|Dosing Group A
861561|NCT01197508|B5|Baseline|Total|Total of all reporting groups
861562|NCT01197508|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861563|NCT01197508|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861564|NCT01197508|B2|Baseline|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861565|NCT01197508|B1|Baseline|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861566|NCT01197508|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861567|NCT01197508|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861568|NCT01197508|P2|Participant Flow|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861569|NCT01197508|P1|Participant Flow|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861570|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861571|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861572|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861573|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861574|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861575|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861576|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861577|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861578|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861579|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861580|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861581|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861582|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861583|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861584|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861585|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861586|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861587|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861588|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861589|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861590|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861591|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861592|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861593|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861594|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861595|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861596|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861597|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861598|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861599|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861600|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861601|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861602|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861603|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861604|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861605|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861606|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861607|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861608|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861609|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861610|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861611|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861612|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861613|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861614|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861615|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
917326|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
861616|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861617|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861618|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861619|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861620|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861621|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861622|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861623|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861624|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861625|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861626|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861627|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861628|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861629|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861630|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861631|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861632|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861633|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861634|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861635|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861636|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861637|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861638|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861639|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
880518|NCT01147406|E4|Reported Event|Cohort 5|N6022 - Active 25 mg
861640|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861641|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861642|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861643|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861644|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861645|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861646|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861647|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861648|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861649|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861650|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861651|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861652|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861653|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861654|NCT01197508|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
861655|NCT01197508|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861656|NCT01197508|O2|Outcome|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861657|NCT01197508|O1|Outcome|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861658|NCT01197508|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
861659|NCT01197508|E3|Reported Event|1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1 mg BID
861660|NCT01197508|E2|Reported Event|0.1 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.1 mg BID
861661|NCT01197508|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
861662|NCT01197495|B3|Baseline|Total|Total of all reporting groups
861663|NCT01197495|B2|Baseline|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
861664|NCT01197495|B1|Baseline|Treatment|Juvederm(R) Ultra XC Injectable Gel
861665|NCT01197495|P2|Participant Flow|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
861666|NCT01197495|P1|Participant Flow|Treatment|Juvederm(R) Ultra XC Injectable Gel
861667|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
861668|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
861669|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
861670|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
861671|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
861672|NCT01197495|O2|Outcome|Control|No treatment for 3 months followed by Juvederm(R) Ultra XC Injectable Gel at Month 3.
861673|NCT01197495|O1|Outcome|Treatment|Juvederm(R) Ultra XC Injectable Gel
861674|NCT01197495|E2|Reported Event|Onset After Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
861675|NCT01197495|E1|Reported Event|Onset Prior to Repeat Treatment|Juvederm(R) Ultra XC Injectable Gel
861676|NCT01197417|B3|Baseline|Total|Total of all reporting groups
861677|NCT01197417|B2|Baseline|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861678|NCT01197417|B1|Baseline|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861679|NCT01197417|P2|Participant Flow|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861680|NCT01197417|P1|Participant Flow|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861681|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861682|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861683|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861684|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861685|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861686|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861687|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861688|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861689|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861690|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861691|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861692|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861693|NCT01197417|O2|Outcome|Placebo Group|"Normal Saline placebo~Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses"
861694|NCT01197417|O1|Outcome|Magnesium Group|"Intravenous Magnesium Sulfate~Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses"
861695|NCT01197417|E2|Reported Event|Placebo Group|Normal Saline placebo Normal Saline Placebo: (1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
861696|NCT01197417|E1|Reported Event|Magnesium Group|Intravenous Magnesium Sulfate Intravenous Magnesium Sulfate: 40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
861697|NCT01197326|B3|Baseline|Total|Total of all reporting groups
861698|NCT01197326|B2|Baseline|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861699|NCT01197326|B1|Baseline|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861700|NCT01197326|P2|Participant Flow|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861701|NCT01197326|P1|Participant Flow|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861702|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861703|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~use of the MP5 EWS patient monitor: All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861704|NCT01197326|O2|Outcome|Group 2|"Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861705|NCT01197326|O1|Outcome|Group 1|"Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor.~Use the MP5 EWS monitor to measure routine vital signs : All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device."
861706|NCT01197326|E2|Reported Event|Patients Who Triggered MET/RRT Calls After the Use of MP5|Patients who triggered MET/RRT calls after the use of the MP5 EWS patient monitor
861707|NCT01197326|E1|Reported Event|Patients Who Triggered MET/RRT Calls Prior to the Use of MP5|Patients who triggered MET/RRT calls prior to the use of the MP5 EWS patient monitor
861708|NCT01196988|B5|Baseline|Total|Total of all reporting groups
861709|NCT01196988|B4|Baseline|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861710|NCT01196988|B3|Baseline|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861810|NCT01196975|P5|Participant Flow|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861711|NCT01196988|B2|Baseline|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861712|NCT01196988|B1|Baseline|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861713|NCT01196988|P4|Participant Flow|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861714|NCT01196988|P3|Participant Flow|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861715|NCT01196988|P2|Participant Flow|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861716|NCT01196988|P1|Participant Flow|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861717|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861718|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861719|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861720|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861721|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861722|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861723|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861724|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861725|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861726|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861727|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861728|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861729|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861730|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861731|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861732|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861733|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861734|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861735|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861736|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861737|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861738|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861739|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861740|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861741|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861742|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861743|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861744|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861745|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861746|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861747|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861748|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861749|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861750|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861751|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861752|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861753|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861754|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861755|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861756|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861757|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861758|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861759|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861760|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861761|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861762|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861763|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861764|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861765|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861766|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861767|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861768|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861769|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861770|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861771|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861772|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861773|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861774|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861775|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861776|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861777|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861778|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861779|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861780|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861781|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861782|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861783|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861784|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861785|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861786|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861787|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861788|NCT01196988|O1|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861789|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861790|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861791|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861792|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861793|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861794|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861795|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861796|NCT01196988|O4|Outcome|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861797|NCT01196988|O3|Outcome|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861798|NCT01196988|O2|Outcome|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861799|NCT01196988|O1|Outcome|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861800|NCT01196988|E4|Reported Event|GSK2321138A 2 Group|Subjects aged 6-35 months received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861801|NCT01196988|E3|Reported Event|GSK2604409A Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2604409A at Day 0 and if unprimed, 2 doses of GSK2604409A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861802|NCT01196988|E2|Reported Event|Fluarix Group|Subjects aged 3-17 years received if primed, 1 dose of Fluarix at Day 0 and if unprimed, 2 doses of Fluarix at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861803|NCT01196988|E1|Reported Event|GSK2321138A 1 Group|Subjects aged 3-17 years received if primed, 1 dose of GSK2321138A at Day 0 and if unprimed, 2 doses of GSK2321138A at Day 0 and Day 28. The vaccine was administered intramuscularly into the deltoid for subjects aged 12 months or above or into the anterolateral region of the thigh for subjects below 12 month of age. The vaccine was administered in the non-dominant side of the body at Day 0 and in the opposite side at Day 28.
861804|NCT01196975|B6|Baseline|Total|Total of all reporting groups
861805|NCT01196975|B5|Baseline|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861806|NCT01196975|B4|Baseline|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861807|NCT01196975|B3|Baseline|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861808|NCT01196975|B2|Baseline|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861809|NCT01196975|B1|Baseline|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861811|NCT01196975|P4|Participant Flow|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861812|NCT01196975|P3|Participant Flow|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861813|NCT01196975|P2|Participant Flow|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861814|NCT01196975|P1|Participant Flow|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861815|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861816|NCT01196975|O4|Outcome|Victoria Strain FluLaval|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861817|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861818|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861819|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861820|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861821|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861822|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861823|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861824|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861825|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861826|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861827|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861828|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861829|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861830|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861831|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861832|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861833|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861834|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861835|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861836|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861837|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861838|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861839|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
862828|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
861840|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861841|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861842|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861843|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861844|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861845|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861846|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861847|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861848|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861849|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861850|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
862013|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
861851|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861852|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861853|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861854|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861855|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861856|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861857|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861858|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861859|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861860|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861861|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861862|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861863|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861864|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
862829|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
861865|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861866|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861867|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861868|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861869|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861870|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861871|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861872|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Yamagata Strain FluLaval Group - Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861873|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861874|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861875|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861876|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861877|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861878|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861879|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861880|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861881|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861882|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861883|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861884|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861885|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861886|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861887|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
862830|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
861888|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861889|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861890|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861891|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861892|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861893|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861894|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861895|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861896|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
917327|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
861897|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861898|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861899|NCT01196975|O3|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861900|NCT01196975|O2|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861901|NCT01196975|O1|Outcome|GSK2282512A Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861902|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861903|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861904|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861905|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861906|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861907|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861908|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861909|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861910|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861911|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861912|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861913|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861914|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861915|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
861916|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861917|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861918|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861919|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861920|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861921|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861922|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861923|NCT01196975|O5|Outcome|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861924|NCT01196975|O4|Outcome|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861925|NCT01196975|O3|Outcome|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861926|NCT01196975|O2|Outcome|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861927|NCT01196975|O1|Outcome|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861928|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861929|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861930|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861931|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861932|NCT01196975|O2|Outcome|GSK2282512A ≥ 61Y Group|Subjects aged 61 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861933|NCT01196975|O1|Outcome|GSK2282512A 18-60Y Group|Subjects aged between 18 and up to 60 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861934|NCT01196975|O6|Outcome|Yamagata Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861935|NCT01196975|O5|Outcome|Yamagata Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861936|NCT01196975|O4|Outcome|Victoria Strain FluLaval ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861937|NCT01196975|O3|Outcome|Victoria Strain FluLaval 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
862831|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
861938|NCT01196975|O2|Outcome|GSK2282512A ≥ 65Y Group|Subjects aged 65 years or above at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861939|NCT01196975|O1|Outcome|GSK2282512A 18-64Y Group|Subjects aged between 18 and up to 64 years inclusive at the time of vaccination received at Day 0 one dose of the GSK2282512A vaccine, from Lot 1, 2 or 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861940|NCT01196975|E5|Reported Event|Yamagata Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-YB vaccine containing the Yamagata B flu strain. The FluLaval®-YB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861941|NCT01196975|E4|Reported Event|Victoria Strain FluLaval Group|Subjects received at Day 0 one dose of FluLaval®-VB vaccine containing the Victoria B flu strain. The FluLaval®-VB vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861942|NCT01196975|E3|Reported Event|GSK2282512A 3 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 3. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861943|NCT01196975|E2|Reported Event|GSK2282512A 2 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 2. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
861944|NCT01196975|E1|Reported Event|GSK2282512A 1 Group|Subjects received at Day 0 one dose of the GSK2282512A vaccine, Lot 1. The GSK2282512A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.dominant arm.
861945|NCT01196923|B1|Baseline|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System. Participants with data available are reported so that not all measures may include data from 20 participants.
861946|NCT01196923|P1|Participant Flow|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
861947|NCT01196923|O1|Outcome|HeartLight Acutely Isolated Pulmonary Veins|
861948|NCT01196923|E1|Reported Event|HeartLight Ablation|Pulmonary Vein Isolation with the HeartLight System
861949|NCT01196741|B3|Baseline|Total|Total of all reporting groups
861978|NCT01196429|B1|Baseline|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
862379|NCT01195831|P2|Participant Flow|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
861950|NCT01196741|B2|Baseline|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861951|NCT01196741|B1|Baseline|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861952|NCT01196741|P2|Participant Flow|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861953|NCT01196741|P1|Participant Flow|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861954|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861955|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861956|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861970|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
862832|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
861957|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861958|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861959|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861960|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
862383|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
861961|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861962|NCT01196741|O2|Outcome|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861963|NCT01196741|O1|Outcome|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861964|NCT01196741|E2|Reported Event|Placebo Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Matched placebo: Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861965|NCT01196741|E1|Reported Event|Saracatinib Plus Weekly Paclitaxel|"Paclitaxel: Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.~Saracatinib: Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression"
861966|NCT01196442|B1|Baseline|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861967|NCT01196442|P1|Participant Flow|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861968|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861969|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
862000|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
880519|NCT01147406|E3|Reported Event|Cohort 3|N6022 - Active 45 mg
861971|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861972|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861973|NCT01196442|O1|Outcome|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861974|NCT01196442|O1|Outcome|Arm I|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~Electrical stimulation pain therapy: Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~Questionnaire administration: Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861975|NCT01196442|E1|Reported Event|MC5A Calmare Therapy|"Patients undergo electric stimulation pain therapy comprising MC5-A Calmare therapy over 30 minutes once daily for 10 days.~electrical stimulation pain therapy : Electrical stimulation for 45 minutes on Day 1, then 30 minutes Days 2-10~questionnaire administration : Brief Pain Inventory at baseline, weekly, then monthly for 3 months"
861976|NCT01196429|B3|Baseline|Total|Total of all reporting groups
861977|NCT01196429|B2|Baseline|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
862380|NCT01195831|P1|Participant Flow|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
861979|NCT01196429|P2|Participant Flow|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
861980|NCT01196429|P1|Participant Flow|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
861981|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
861982|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
861983|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
861984|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
861985|NCT01196429|O2|Outcome|Japan|Patients enrolled from Japan
861986|NCT01196429|O1|Outcome|US/Korea|Patients enrolled from the U.S.and Korea
861987|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
861988|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
861989|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
861990|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
861991|NCT01196429|O2|Outcome|Japan|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
861992|NCT01196429|O1|Outcome|US/Korea|Progression-free survival (PFS) was defined as the period from study entry until disease progression, death, or the last date of contact. Patients censored prior to 12 months were considered failures in this analysis. Progression was based on RECIST 1.1
861993|NCT01196429|E2|Reported Event|Japan|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
861994|NCT01196429|E1|Reported Event|US/Korea|Temsirolimus (CCI-779) 25mg IV Days 1 and 8, Carboplatin AUC= 6 IV Day 1 and Paclitaxel 175 mg/m2 IV on Day 1 every 3 weeks for cycles 1-6 or disease progression. Followed by consolidation therapy with temsirolimus (CCI-779) 25 mg weekly on Days 1, 8 and 15 every 3 weeks cycles 7-17 or until disease progression
861995|NCT01196104|B3|Baseline|Total|Total of all reporting groups
861996|NCT01196104|B2|Baseline|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
861997|NCT01196104|B1|Baseline|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
861998|NCT01196104|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
861999|NCT01196104|P1|Participant Flow|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862001|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862002|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862003|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862004|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862005|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862006|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862007|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862008|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862009|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862010|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862011|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862012|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862014|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862015|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862016|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862017|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862018|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862019|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862020|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862021|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862022|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862023|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862024|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862025|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862026|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862027|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862028|NCT01196104|O2|Outcome|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
862029|NCT01196104|O1|Outcome|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
862030|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862031|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862032|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862033|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862833|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862034|NCT01196104|O2|Outcome|Insulin Aspart + Insulin Glargine|Insulin Aspart (prior to each meal) and Insulin Glargine (once or twice daily) ; doses individualized for each patient
862035|NCT01196104|O1|Outcome|Technosphere Insulin + Insulin Glargine|Technosphere Insulin Inhalation Powder (administered prior to each meal) in combination with insulin glargine (once or twice daily); doses individualized for each patient
862036|NCT01196104|E2|Reported Event|Comparator|"Insulin Glargine and Insulin Aspart~Insulin Aspart: Usual Care~Insulin Glargine"
862037|NCT01196104|E1|Reported Event|Technosphere® Insulin Inhalation Powder (TI)|"Insulin Glargine and Technosphere® Insulin Inhalation Powder~Technosphere® Insulin Inhalation Powder~Insulin Glargine"
862038|NCT01196078|B3|Baseline|Total|Total of all reporting groups
862039|NCT01196078|B2|Baseline|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862040|NCT01196078|B1|Baseline|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862041|NCT01196078|P2|Participant Flow|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 milligrams per square meter (mg/m^2) orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 adverse events [AEs]) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862042|NCT01196078|P1|Participant Flow|Erlotinib|Participants received erlotinib 150 milligrams (mg), tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862043|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862044|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862136|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862045|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862046|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862047|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862048|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862049|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862050|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862051|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862052|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862053|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862054|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862055|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862056|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862057|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862058|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862090|NCT01196026|P3|Participant Flow|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862834|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862059|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862060|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862061|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862062|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862063|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862064|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862065|NCT01196078|O2|Outcome|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862066|NCT01196078|O1|Outcome|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862102|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862381|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
862067|NCT01196078|E2|Reported Event|Vinorelbine|"Cycle 1 (21-day cycle): Participants received vinorelbine 60 mg/m^2 orally on Days 1 and 8, followed by 1 week off.~Cycles 2 and beyond (21-day-cycles): Participants received vinorelbine 80 mg/m^2 (in the absence of Grade 2 AEs) orally, on Days 1 and 8, followed by 1 week off. Treatment continued until disease progression, unacceptable toxicity, or participant withdrawal."
862068|NCT01196078|E1|Reported Event|Erlotinib|Participants received erlotinib 150 mg, tablets, orally, once a day until disease progression, unacceptable toxicity, or participant withdrawal.
862069|NCT01196052|B1|Baseline|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862070|NCT01196052|P1|Participant Flow|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862071|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862072|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862073|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862074|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862075|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862076|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862077|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862078|NCT01196052|O1|Outcome|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862079|NCT01196052|E1|Reported Event|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg was administered intravenously on Day 1 of each 3-week treatment cycle up to a maximum of 17 cycles.
862080|NCT01196026|B7|Baseline|Total|Total of all reporting groups
862081|NCT01196026|B6|Baseline|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862082|NCT01196026|B5|Baseline|Havrix Junior 12-35 Months Group|Subjects aged 12-35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix Junior vaccine.
862083|NCT01196026|B4|Baseline|Havrix Junior 6-11 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862084|NCT01196026|B3|Baseline|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862085|NCT01196026|B2|Baseline|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862086|NCT01196026|B1|Baseline|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862087|NCT01196026|P6|Participant Flow|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862088|NCT01196026|P5|Participant Flow|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862089|NCT01196026|P4|Participant Flow|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862835|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862091|NCT01196026|P2|Participant Flow|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862092|NCT01196026|P1|Participant Flow|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862093|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862094|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862095|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862096|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862097|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862098|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862099|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862100|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862101|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862103|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862104|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862105|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862106|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862107|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862108|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862109|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862110|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862111|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862112|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862113|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862114|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862115|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862116|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862117|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862118|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862119|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862120|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862121|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862122|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862123|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862836|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862124|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862125|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862126|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862127|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862128|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862129|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862130|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862131|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862132|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862133|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862134|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862135|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862137|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862138|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862139|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862140|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862141|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862142|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862143|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862144|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862145|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862146|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862147|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862148|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862149|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862150|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862151|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862152|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862153|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862154|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862155|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862156|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862157|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862158|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862159|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862160|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862161|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862162|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862163|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862164|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862165|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862166|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862167|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862168|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862169|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862382|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
862170|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862171|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862172|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862173|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862174|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862175|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862176|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862177|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862178|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862179|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862180|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862181|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862182|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862183|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862184|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862185|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862186|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862187|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862188|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862189|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862190|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862363|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
862191|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862192|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862193|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862194|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862195|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862196|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862197|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862198|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862199|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862200|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862201|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862202|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862203|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862204|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862205|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862206|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862207|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862208|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862209|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862210|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862211|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862212|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862213|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862214|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862215|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862216|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862217|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862218|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862219|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862220|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862221|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862222|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862223|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862364|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
862224|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862225|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862226|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862227|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862228|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862229|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862230|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862231|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862232|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862233|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862234|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862235|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862236|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862237|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862238|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862239|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862240|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862241|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862242|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862243|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862244|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862245|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862246|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862247|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862248|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862249|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862250|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862251|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862252|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862253|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862254|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862255|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862256|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862257|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862258|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862259|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862260|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862261|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862262|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862263|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862264|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862265|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862266|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862267|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862268|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862269|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862270|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862271|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862272|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862273|NCT01196026|O8|Outcome|Havrix Junior All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive two doses of Havrix Junior vaccine.
862274|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862275|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862276|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862277|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862278|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862279|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862280|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862281|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862282|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862283|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862284|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862285|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862286|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862287|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862288|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862289|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862290|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862291|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862292|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862293|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862294|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862295|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862296|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862297|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862298|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862299|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862300|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862301|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862302|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
917328|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
862303|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862304|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862305|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862306|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862307|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862308|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862309|NCT01196026|O7|Outcome|Fluarix All Ages Group|Subjects aged 6 months to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix vaccine depending on their priming status.
862310|NCT01196026|O6|Outcome|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862311|NCT01196026|O5|Outcome|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862312|NCT01196026|O4|Outcome|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862313|NCT01196026|O3|Outcome|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862314|NCT01196026|O2|Outcome|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862315|NCT01196026|O1|Outcome|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862316|NCT01196026|E8|Reported Event|Havrix Junior Group|Subjects received 1 dose of Havrix Junior vacine. The second dose was administered outside the study setting.
862317|NCT01196026|E7|Reported Event|Fluarix Group|subjects received 1 or doses of Fluarix vaccine based on age and priming status
862318|NCT01196026|E6|Reported Event|Havrix Junior 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862319|NCT01196026|E5|Reported Event|Havrix Junior 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862320|NCT01196026|E4|Reported Event|Havrix Junior 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine will receive two doses of Havrix™ Junior vaccine.
862321|NCT01196026|E3|Reported Event|Fluarix 3-9 Years Group|Subjects aged 3 to 9 years and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862322|NCT01196026|E2|Reported Event|Fluarix 12-35 Months Group|Subjects aged 12 to 35 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862323|NCT01196026|E1|Reported Event|Fluarix 6-11 Months Group|Subjects aged 6 to 11 months and previously vaccinated with Pandemrix vaccine, will receive one or two doses of Fluarix™ vaccine depending on their priming status.
862324|NCT01195948|B4|Baseline|Total|Total of all reporting groups
862325|NCT01195948|B3|Baseline|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862326|NCT01195948|B2|Baseline|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862327|NCT01195948|B1|Baseline|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862328|NCT01195948|P3|Participant Flow|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862329|NCT01195948|P2|Participant Flow|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862330|NCT01195948|P1|Participant Flow|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862331|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862332|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862333|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862334|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862335|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862336|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862337|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862338|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862339|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862340|NCT01195948|O3|Outcome|Placebo|Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862341|NCT01195948|O2|Outcome|B27PD 4 mg|Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862342|NCT01195948|O1|Outcome|B27PD 1 mg|Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.
862343|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
862344|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862345|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862346|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
862347|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862348|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862408|NCT01195779|P14|Participant Flow|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862349|NCT01195948|O3|Outcome|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
862350|NCT01195948|O2|Outcome|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862351|NCT01195948|O1|Outcome|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862352|NCT01195948|E3|Reported Event|Placebo|"Participants randomly assigned to the placebo arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~Placebo: Capsule with no active ingredients to mimic B27PD"
862353|NCT01195948|E2|Reported Event|B27PD 4 mg|"Participants randomly assigned to the B27PD 4 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862354|NCT01195948|E1|Reported Event|B27PD 1 mg|"Participants randomly assigned to the B27PD 1 mg arm were instructed to take the capsule orally three times per week (i.e., Monday, Wednesday and Friday) in the morning, at least four hours after the last meal and at least 30 minutes before the next meal for 24 weeks.~B27PD"
862375|NCT01195844|E1|Reported Event|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
862376|NCT01195831|B3|Baseline|Total|Total of all reporting groups
862377|NCT01195831|B2|Baseline|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
862378|NCT01195831|B1|Baseline|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
862355|NCT01195922|B1|Baseline|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
862356|NCT01195922|P1|Participant Flow|Sirolimus|Rapamycin (sirolimus), dispensed as either tablets or an oral solution for patients with dysphagia was administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Dose reductions to 3 mg by mouth once per day were implemented if levels of rapamycin > 20 ng/ml occurred on Days 8 or 15.
862357|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
862358|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
862359|NCT01195922|O1|Outcome|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
862360|NCT01195922|E1|Reported Event|Sirolimus|Rapamycin (sirolimus), which will be dispensed as either tablets or an oral solution for patients with dysphagia (see Section 0), will be administered orally as a single loading dose of 15 mg on the first day and 5 mg once a day for the next 20 days. Serum rapamycin levels will be obtained on Days 8, 15, 22, and 28 (if rapamycin is > 3 ng/ml at Day 28, the subject will return daily, or as is convenient, for testing until rapamycin is ≤ 3 ng/ml). Dose reduction to 3 mg by mouth once per day will occur if trough levels of rapamycin > 20 ng/ml occur on Days 8 or 15 (see Appendix A, Study Calendar for visit windows). If a dose is decreased at Day 8, it will not be increased at Day 15 regardless of serum rapamycin levels. If subjects receiving 3 mg have levels > 20 ng/ml at Day 15, rapamycin will be reduced to 2 mg once per day. Rapamycin will cease on Day 21 regardless of level.
862361|NCT01195844|B1|Baseline|Children Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.
862362|NCT01195844|P1|Participant Flow|Children Hospitalized For Diarrhea|Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
862837|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862365|NCT01195844|O2|Outcome|Total Number Diagnosed With Rotavirus Diarrhea|Children up to 5 years of age diagnosed with rotavirus diarrhea in the 4 Brazilian hospital research centers
862366|NCT01195844|O1|Outcome|Total Number Hospitalized For Diarrhea of Any Cause|Total number of children up to 5 years of age hospitalized for diarrhea of any cause in the 4 Brazilian hospital research centers
862367|NCT01195844|O1|Outcome|Children Hospitalized For Rotavirus-Positive Diarrhea|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the 4 Brazilian hospital research centers
862368|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea Who Provided a Fecal Sample|Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers
862369|NCT01195844|O4|Outcome|São Paulo (Southeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
862370|NCT01195844|O3|Outcome|Porto Alegre (South)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
862371|NCT01195844|O2|Outcome|Goiânia (Center-West)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
862372|NCT01195844|O1|Outcome|Salvador (Northeast)|Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Salvador (Northeast Brazil) hospital research center
862373|NCT01195844|O1|Outcome|Children Hospitalized for Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
862374|NCT01195844|O1|Outcome|Children Hospitalized For Diarrhea|Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
862384|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
862385|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
862386|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
862387|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
862388|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
862389|NCT01195831|O2|Outcome|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
862390|NCT01195831|O1|Outcome|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
862391|NCT01195831|E2|Reported Event|Calcipotriol Scalp Solution|Calcipotriol (as hydrate) 50 mcg/ml
862392|NCT01195831|E1|Reported Event|Xamiol® Gel|Calcipotriol (as hydrate) 50mcg/g plus betamethasone 0.5mg/g (dipropionate)
862393|NCT01195779|B15|Baseline|Total|Total of all reporting groups
862394|NCT01195779|B14|Baseline|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862395|NCT01195779|B13|Baseline|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862396|NCT01195779|B12|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862397|NCT01195779|B11|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862398|NCT01195779|B10|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862399|NCT01195779|B9|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862400|NCT01195779|B8|Baseline|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862401|NCT01195779|B7|Baseline|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862402|NCT01195779|B6|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862403|NCT01195779|B5|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862404|NCT01195779|B4|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862405|NCT01195779|B3|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862406|NCT01195779|B2|Baseline|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862407|NCT01195779|B1|Baseline|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862409|NCT01195779|P13|Participant Flow|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862410|NCT01195779|P12|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862411|NCT01195779|P11|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862412|NCT01195779|P10|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862413|NCT01195779|P9|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862414|NCT01195779|P8|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862415|NCT01195779|P7|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862416|NCT01195779|P6|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862417|NCT01195779|P5|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862418|NCT01195779|P4|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862419|NCT01195779|P3|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862420|NCT01195779|P2|Participant Flow|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862421|NCT01195779|P1|Participant Flow|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862422|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862639|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
862423|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862424|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862425|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862426|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862427|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862428|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862429|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862430|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862431|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862432|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862433|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862434|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862435|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862436|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862437|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862438|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862439|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862440|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862441|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862442|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
880520|NCT01147406|E2|Reported Event|Cohort 2 and 4|N6022 - Active 15 mg
862443|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862444|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862445|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862446|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862447|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862448|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862449|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862450|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862451|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862452|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862453|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862454|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862455|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862456|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862640|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862457|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862458|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862459|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862460|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862461|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862462|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862463|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862464|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862465|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862466|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862467|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862468|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862469|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862470|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862471|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862472|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862473|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862474|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862475|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862476|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862838|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862477|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862478|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862479|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862480|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862481|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862482|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862483|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862484|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862485|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862486|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862487|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862488|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862489|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862490|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862491|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862492|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862493|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862494|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862495|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862496|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862497|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862498|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862499|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862500|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862501|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862502|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862503|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862504|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862505|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862506|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862507|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862508|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862509|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862510|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862511|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862839|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862512|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862513|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862514|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862515|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862516|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862517|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862518|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862519|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862520|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862521|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862522|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862523|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862524|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862525|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862526|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862527|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862528|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862529|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862530|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862531|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862532|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862533|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862534|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862535|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862536|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862537|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862538|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862539|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862540|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862541|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862542|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862543|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862544|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862545|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862840|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862546|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862547|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862548|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862549|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862550|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862551|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862552|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862553|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862554|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862555|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862556|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862557|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862558|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862559|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862560|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862561|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862562|NCT01195779|O14|Outcome|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862563|NCT01195779|O13|Outcome|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862564|NCT01195779|O12|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862565|NCT01195779|O11|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862566|NCT01195779|O10|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862567|NCT01195779|O9|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862568|NCT01195779|O8|Outcome|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862569|NCT01195779|O7|Outcome|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862570|NCT01195779|O6|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862571|NCT01195779|O5|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862572|NCT01195779|O4|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862573|NCT01195779|O3|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862574|NCT01195779|O2|Outcome|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862575|NCT01195779|O1|Outcome|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862576|NCT01195779|E14|Reported Event|Fluarix Group|Subjects received 2 doses of Fluarix Vaccine.
862577|NCT01195779|E13|Reported Event|GSK2321138A Vaccine Group|Subjects received 2 doses of GSK Biologicals’ non-adjuvanted quadrivalent influenza candidate vaccine (GSK2321138A).
862578|NCT01195779|E12|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862579|NCT01195779|E11|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B3.
862580|NCT01195779|E10|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862581|NCT01195779|E9|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B2.
862582|NCT01195779|E8|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation B1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862583|NCT01195779|E7|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation B1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation B1.
862584|NCT01195779|E6|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A3 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862585|NCT01195779|E5|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A3 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A3.
862586|NCT01195779|E4|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A2 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862587|NCT01195779|E3|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A2 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A2.
862588|NCT01195779|E2|Reported Event|GSK2584786A Vaccine 2 Doses of Formulation A1 Group|Subjects received 2 doses of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862589|NCT01195779|E1|Reported Event|GSK2584786A Vaccine 1 Dose of Formulation A1 Group|Subjects received 1 dose of GSK Biologicals’ adjuvanted quadrivalent influenza candidate vaccine (GSK2584786A) Formulation A1.
862590|NCT01195701|B3|Baseline|Total|Total of all reporting groups
862591|NCT01195701|B2|Baseline|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862592|NCT01195701|B1|Baseline|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862593|NCT01195701|P2|Participant Flow|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862594|NCT01195701|P1|Participant Flow|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862595|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862596|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862597|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862598|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862599|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862600|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862601|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862602|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862603|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862604|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862605|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862606|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862607|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862608|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862609|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862610|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862611|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862612|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862613|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862614|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862615|NCT01195701|O2|Outcome|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862616|NCT01195701|O1|Outcome|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862617|NCT01195701|E2|Reported Event|Normal Orgasmic Function|Women who report that they usually or always achieve sexual climax will be the controls in this study.
862618|NCT01195701|E1|Reported Event|Anorgasmia (Cases)|Women with difficulty or inability to reach sexual climax will be the cases in this study.
862619|NCT01195675|B1|Baseline|Study Overall|Total number of patients randomised and treated in the study.
862655|NCT01195662|P1|Participant Flow|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862620|NCT01195675|P1|Participant Flow|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, placebo controlled, 5-period crossover trial, participants were randomised to one of ten possible treatment sequences. The treatments administered were~25mg empa administered orally on day 1 of the treatment period~200mg empa administered orally on day 1 of the treatment period~400mg moxifloxacin administered orally on day 1 of the treatment period~Placebo 1 administered orally on day 1 of the treatment period~Placebo 2 administered orally on day 1 of the treatment period~The trial was double-blind for the placebo and Empagliflozin (Empa) treatments, but open-label for the moxifloxacin treatment. A washout period of at least 1 week was respected between drug administrations."
862621|NCT01195675|O4|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
862622|NCT01195675|O3|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
862623|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
862624|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862625|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
862626|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
862627|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
862628|NCT01195675|O3|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
862629|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
862630|NCT01195675|O1|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
862631|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
862632|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862633|NCT01195675|O2|Outcome|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (consisting of 8 tablets with strength 25 mg)
862634|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862635|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
862636|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862637|NCT01195675|O2|Outcome|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
862638|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862641|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
862642|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862643|NCT01195675|O2|Outcome|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet with strength 25mg) plus 7 tablets of placebo.
862644|NCT01195675|O1|Outcome|Placebo|Single oral dose of placebo (8 tablets).
862645|NCT01195675|E4|Reported Event|Moxifloxacin|Single oral dose of moxifloxacin 400 mg (1 tablet)
862646|NCT01195675|E3|Reported Event|Empa 200 mg|Single oral dose of Empagliflozin (Empa) 200 mg (8 tablets of 25 mg)
862647|NCT01195675|E2|Reported Event|Empa 25 mg|Single oral dose of Empagliflozin (Empa) 25mg (1 tablet) plus 7 tablets of placebo.
862648|NCT01195675|E1|Reported Event|Placebo|Single oral dose of placebo (8 tablets).
862649|NCT01195662|B4|Baseline|Total|Total of all reporting groups
862650|NCT01195662|B3|Baseline|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|Dapagliflozin: Tablets, Oral, 5 mg, once daily, Up to 12 weeks. This arm discontinued with implementation of Amendment 8 to the protocol (1 November 2011). Study continued to enroll participants in other 2 arms post Amendment 8. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862651|NCT01195662|B2|Baseline|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862652|NCT01195662|B1|Baseline|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862653|NCT01195662|P3|Participant Flow|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
862654|NCT01195662|P2|Participant Flow|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862692|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862693|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862656|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862657|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862658|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862659|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862660|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862661|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862662|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
917329|NCT01037218|O4|Outcome|Placebo|Placebo tablets
862663|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862664|NCT01195662|O3|Outcome|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
862665|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862666|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862667|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862668|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862669|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862670|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862694|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862841|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862671|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862672|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks.Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862673|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862674|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862675|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862676|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862677|NCT01195662|O2|Outcome|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862678|NCT01195662|O1|Outcome|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862679|NCT01195662|E3|Reported Event|Dagagliflozin 5 mg (Arm Discontinued With Amendment 8)|"Dapagliflozin: Tablets, Oral, 5 mg, once a day for up to12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.~This arm was discontinued with Amendment 8 to the protocol (implemented 1 November 2011) and the other 2 arms continued to enroll. This arm is not included in primary and secondary efficacy analysis."
862680|NCT01195662|E2|Reported Event|Dapagliflozin 10 mg|Dapagliflozin: Tablets, Oral, 10 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862681|NCT01195662|E1|Reported Event|Placebo Matching Dapagliflozin|Placebo matching dapagliflozin: Tablets, Oral, 0 mg, once daily, Up to 12 weeks. Non-investigational medications used in this study were antidiabetic drug(s), including oral antidiabetic drugs and insulin, angiotensin-converting enzyme inhibitors or angiotensin receptor blockers, and an additional antihypertensive drug. All non-investigational medications were commercially available and were not supplied by the Sponsor.
862682|NCT01195636|B3|Baseline|Total|Total of all reporting groups
862683|NCT01195636|B2|Baseline|Placebo First, Then XPF-002|Placebo ointment applied twice daily for 3 weeks followed by XPF-002 ointment applied twice daily for 3 weeks (after a washout period)
862684|NCT01195636|B1|Baseline|XPF-002 First, Then Placebo|XPF-002 ointment applied twice daily for 3 weeks followed by Placebo ointment applied twice daily for 3 weeks (after a washout period)
862685|NCT01195636|P2|Participant Flow|Placebo First, Then XPF-002|In the first intervention period Placebo ointment was applied twice daily for 3 weeks. After a washout period, XPF-002 ointment (8% strength) was applied twice daily for 3 weeks in the second intervention period.
862686|NCT01195636|P1|Participant Flow|XPF-002 First, Then Placebo|In the first intervention period XPF-002 ointment (8% strength) was applied twice daily for 3 weeks. After a washout period, Placebo ointment was applied twice daily for 3 weeks in the second intervention period.
862687|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862688|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862689|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862690|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862691|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862826|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862695|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862696|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862697|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862698|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862699|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862700|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862701|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862702|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862703|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862704|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862705|NCT01195636|O2|Outcome|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862706|NCT01195636|O1|Outcome|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862707|NCT01195636|E2|Reported Event|Placebo|Placebo: Vehicle only ointment, applied twice daily for 3 weeks in either first intervention period or second intervention period.
862708|NCT01195636|E1|Reported Event|XPF-002|XPF-002: 8% strength ointment, applied twice daily for 3 weeks in either the first intervention period or second intervention period.
862709|NCT01195623|B3|Baseline|Total|Total of all reporting groups
862710|NCT01195623|B2|Baseline|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
862711|NCT01195623|B1|Baseline|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
917330|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
862712|NCT01195623|P2|Participant Flow|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
862713|NCT01195623|P1|Participant Flow|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
862714|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
862715|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
862716|NCT01195623|O2|Outcome|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
862717|NCT01195623|O1|Outcome|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
862718|NCT01195623|E2|Reported Event|Varicose Vein Surgery Without Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination only
862719|NCT01195623|E1|Reported Event|Varicose Vein Surgery With Preoperative Duplex|The surgeon has planned surgery for varicose veins from a clinical examination and has then the extra information available from a preoperative duplex examination to plan surgery more in detail
862720|NCT01195597|B1|Baseline|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
862721|NCT01195597|P1|Participant Flow|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
862722|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
862723|NCT01195597|O1|Outcome|Smokers Not Willing to Quit|"7.4 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy)"
862724|NCT01195597|E1|Reported Event|ENDD Group|Well characterized group of 40 regular smokers not intending to quit experimenting the E-Cigarette with 7.2 mg nicotine cartridges.
862725|NCT01195584|B4|Baseline|Total|Total of all reporting groups
862726|NCT01195584|B3|Baseline|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
862727|NCT01195584|B2|Baseline|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
862728|NCT01195584|B1|Baseline|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
862729|NCT01195584|P3|Participant Flow|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
862730|NCT01195584|P2|Participant Flow|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
862731|NCT01195584|P1|Participant Flow|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
862732|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
862733|NCT01195584|O1|Outcome|Hospitalization|Days of hospitalization
862734|NCT01195584|O1|Outcome|Number of Segments|Number of affected spine segments
862735|NCT01195584|O1|Outcome|Blood Loss|
862736|NCT01195584|O1|Outcome|Duration|Duration of surgery
862827|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862737|NCT01195584|O1|Outcome|Complications|Postoperative complications; complications include fever, subfebrile temerature, neurogenic deficit, temorary meningism, pulmonary embolism, TIA, cardiac ischemia, urinary tract infection, respiratory infection and pneumonia
862738|NCT01195584|E3|Reported Event|BMI >= 30|Body Mass Index (BMI) according to WHO definition. BMI >= 30 is defined as 'obese'.
862739|NCT01195584|E2|Reported Event|25 <= BMI < 30|Body Mass Index (BMI) according to WHO definition. BMI >= 25 and < 30 is defined as 'overweight'.
862740|NCT01195584|E1|Reported Event|BMI < 25|Body Mass Index (BMI) according to WHO definition. BMI < 25 is defined as 'normal weight'.
862741|NCT01195467|B1|Baseline|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
862742|NCT01195467|P1|Participant Flow|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and trested for 12 weeks.
862743|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
862744|NCT01195467|O1|Outcome|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
862745|NCT01195467|E1|Reported Event|Single Arm|No randomisation as this is a single arm trial. All subjects switched from one tablet once daily of Atripla to Truvada at baseline and treated for 12 weeks.
862746|NCT01195415|B1|Baseline|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
862747|NCT01195415|P1|Participant Flow|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
862748|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
862749|NCT01195415|O1|Outcome|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
864310|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
862750|NCT01195415|E1|Reported Event|Treatment (Vismodegib, Gemcitabine Hydrochloride)|Patients receive vismodegib PO QD on days 1-28 and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 (beginning in course 2). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
862751|NCT01195363|B3|Baseline|Total|Total of all reporting groups
862752|NCT01195363|B2|Baseline|Quetiapine SR Placebo|mood stabilizer plus quetiapine SR placebo
862753|NCT01195363|B1|Baseline|Active Quetiapine SR|mood stabilizer plus active quetiapine sr
862754|NCT01195363|P2|Participant Flow|Quetiapine sr Placebo 200-600mg, po, qd|mood stabilizer plus quetiapine SR placebo
862755|NCT01195363|P1|Participant Flow|Quetiapine SR, 200-600mg , po, QD|mood stabilizer plus active quetiapine SR
862756|NCT01195363|O2|Outcome|Placebo Quetiapine S.R. 200-600mg, po, qd|mood stabilizer plus quetiapine S.R. placebo
862757|NCT01195363|O1|Outcome|Active Quetiapine S.R., 200-600mg, po, qd|Atypical antipsychotic quetiapine S.R. plus mood stabilizer
862758|NCT01195363|E2|Reported Event|Mood Stabilizer Plus Quetiapine sr Placebo|mood stabilizer plus quetiapine SR placebo
862759|NCT01195363|E1|Reported Event|Mood Stabilizer Plus Quetiapine SR|mood stabilizer plus active quetiapine SR
862760|NCT01195272|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862761|NCT01195272|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) intravenously (IV), once every 4 weeks up to 52 weeks (total of 13 infusions).
862762|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862763|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862764|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862765|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862766|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862767|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862768|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862769|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862770|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862771|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862772|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862773|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862774|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
880521|NCT01147406|E1|Reported Event|Cohort 1|N6022 - Active 5 mg
862775|NCT01195272|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862776|NCT01195272|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV, once every 4 weeks up to 52 weeks (total of 13 infusions).
862777|NCT01195116|B3|Baseline|Total|Total of all reporting groups
862778|NCT01195116|B2|Baseline|Normal Saline|Normal Saline: 1mcg/kg/hr
862779|NCT01195116|B1|Baseline|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
862780|NCT01195116|P2|Participant Flow|Normal Saline|Normal Saline: 1mcg/kg/hr
862781|NCT01195116|P1|Participant Flow|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
862782|NCT01195116|O2|Outcome|Normal Saline|Normal Saline: 1mcg/kg/hr
862783|NCT01195116|O1|Outcome|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
862784|NCT01195116|E2|Reported Event|Normal Saline|Normal Saline: 1mcg/kg/hr
862936|NCT01194531|P2|Participant Flow|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
862937|NCT01194531|P1|Participant Flow|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
864311|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
862785|NCT01195116|E1|Reported Event|Dexmedetomidine|"Dexmedetomidine is a FDA-approved medication that is a highly selective, short acting, alpha-2 adrenoreceptor agonist. To date, its safety and efficacy is well studied and established.It produces sedative, anxiolytic, and analgesic effects when used while patients undergo procedures and surgical operations.Interstitial Cystitis, as a chronic visceral pain syndrome, has the potential to have a neuropathic component for which an alpha-2 adrenergic agonist may be more effective than other classes, including opioids or NSAIDs.~Dexmedetomidine: 1 mcg/kg/hour"
862786|NCT01195103|B4|Baseline|Total|Total of all reporting groups
862787|NCT01195103|B3|Baseline|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
862788|NCT01195103|B2|Baseline|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
862789|NCT01195103|B1|Baseline|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
862790|NCT01195103|P3|Participant Flow|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
862791|NCT01195103|P2|Participant Flow|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
862792|NCT01195103|P1|Participant Flow|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
862793|NCT01195103|O3|Outcome|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
862794|NCT01195103|O2|Outcome|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
862795|NCT01195103|O1|Outcome|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
862796|NCT01195103|E3|Reported Event|Placebo + Midazolam|Placebo initial bolus with dose of midazolam based on patient's weight
862797|NCT01195103|E2|Reported Event|6.5 mg/kg Lusedra|6.5 mg/kg Lusedra initial bolus
862798|NCT01195103|E1|Reported Event|10 mg/kg Lusedra|10 mg/kg Lusedra initial bolus
862799|NCT01195090|B3|Baseline|Total|Total of all reporting groups
862800|NCT01195090|B2|Baseline|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862801|NCT01195090|B1|Baseline|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862802|NCT01195090|P2|Participant Flow|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862803|NCT01195090|P1|Participant Flow|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862804|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862805|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862806|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862807|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862808|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862809|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862810|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862811|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862812|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862813|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862814|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862815|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862816|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862817|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862818|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862819|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862820|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862821|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862822|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862823|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862824|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862825|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862842|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862843|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862844|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862845|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862846|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862847|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862848|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862849|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862850|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862851|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862852|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862853|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862854|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862855|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862856|NCT01195090|O2|Outcome|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862857|NCT01195090|O1|Outcome|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862858|NCT01195090|E2|Reported Event|Pioglitazone|add pioglitazone 30mg/d to pre-study OADs
862859|NCT01195090|E1|Reported Event|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
862860|NCT01195025|B1|Baseline|Dilution Effects of iv Fluids|"Three experiments:~A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxy ethyl starch (HES) 6% 10 mL/kg bodyweight during 30 min C. A combination of A and B. HES during 0-30 min and Ringer's during 105-135 minutes."
862938|NCT01194531|O2|Outcome|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
862939|NCT01194531|O1|Outcome|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
864312|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
862861|NCT01195025|P5|Participant Flow|A. Colloid+Acetated Ringers, B.Colloid and C. Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected."
862862|NCT01195025|P4|Participant Flow|A.Colloid, B. Acetated Ringers and C. Colloid+Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
862863|NCT01195025|P3|Participant Flow|A. Acetated Ringers, B. Colloid+Acetated Ringers and C.Colloid|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by 150 minutes of equilibration, when blood samples were collected~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples."
862864|NCT01195025|P2|Participant Flow|A. Colloid, B. Colloid+Acetated Ringers and C.Acetated Ringers|"First intervention: A. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected"
862865|NCT01195025|P1|Participant Flow|A. Acetated Ringers, B.Colloid and C. Colloid+Acetated Ringers|"First intervention: A. acetated Ringers 20 ml/kg bodyweight during 30 minutes followed by150 minutes of equilibration, when blood samples were collected.~Washout >7 days~Second intervention: B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed by 390 minutes of equilibration and blood samples.~Washout > 7 Days~Third intervention: C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes. thereafter the subjects stayed for Another 285 minutes of equilibration and blood samples."
862866|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
862867|NCT01195025|O1|Outcome|Colloid (Voluven), Acetated Ringers and a Combination of Both.|"A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes~The combined experiment is not included since infusions were performed in sequence, which made the comparison of the bias for the two different fluids irrelevant."
862868|NCT01195025|O1|Outcome|Venous Hemoglobin and Non-invasive Hemoglobin (SpHb)|"A comparison of all paired hemoglobin measurements (B-Hb and SpHb) during the experiments for all the 10 volunteers.~Relative difference(%) = (SpHb - Hb)/((Hb+SpHb)/2) x 100"
862869|NCT01195025|O1|Outcome|Hydroxyethyl Starch, Ringers and a Combination of Both.|A. acetated Ringers 20 ml/kg bodyweight during 30 minutes B. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes. C. Hydroxyethyl starch (HES 6 %, 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 20 ml/kg bodyweight during 30 minutes.
862870|NCT01195025|E1|Reported Event|Colloid-, Acetated Ringers and Combined|"Voluven, acetated Ringers: Infusions at three different occasions separated by at least one week.~A. acetated Ringers 25 ml/kg bodyweight during 30 minutes B. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes. C. Voluven 6 % (starch solution) 10 ml/kg bodyweight during 30 minutes followed 90 minutes later by acetated Ringers 15 ml/kg bodyweight during 30 minutes."
880855|NCT01146457|O3|Outcome|Morphine 50|Morphine 50 micrograms
862871|NCT01194999|B1|Baseline|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
862872|NCT01194999|P1|Participant Flow|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
862873|NCT01194999|O1|Outcome|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
862874|NCT01194999|E1|Reported Event|Pubovaginal Sling Procedure|Patients undergoing pubovaginal slings for stress urinary incontinence.
862875|NCT01194973|B1|Baseline|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862876|NCT01194973|P1|Participant Flow|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862877|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862878|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862879|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862880|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862881|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862882|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862883|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862884|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862885|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862886|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862887|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862920|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862921|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
864165|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
862888|NCT01194973|O1|Outcome|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862889|NCT01194973|E1|Reported Event|Eculizumab|Eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
862890|NCT01194908|B1|Baseline|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
862891|NCT01194908|P1|Participant Flow|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
862892|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
862893|NCT01194908|O1|Outcome|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
862894|NCT01194908|E1|Reported Event|Arm A|"Patients treated with decitabine and LBH589~Decitabine, LBH589, Tamoxifen: Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
862895|NCT01194869|B1|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
862896|NCT01194869|P1|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
862897|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
862898|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
862899|NCT01194869|O1|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
862900|NCT01194869|E1|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
862901|NCT01194830|B3|Baseline|Total|Total of all reporting groups
862902|NCT01194830|B2|Baseline|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862903|NCT01194830|B1|Baseline|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862904|NCT01194830|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862905|NCT01194830|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862906|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862907|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862908|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862909|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862910|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862911|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862912|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862913|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862914|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862915|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862916|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862917|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862918|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862919|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862922|NCT01194830|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862923|NCT01194830|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862924|NCT01194830|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
862925|NCT01194830|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
862926|NCT01194674|B1|Baseline|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
862927|NCT01194674|P1|Participant Flow|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
862928|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
862929|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
862930|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
862931|NCT01194674|O1|Outcome|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
862932|NCT01194674|E1|Reported Event|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
862933|NCT01194531|B3|Baseline|Total|Total of all reporting groups
862934|NCT01194531|B2|Baseline|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
862935|NCT01194531|B1|Baseline|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
862940|NCT01194531|E2|Reported Event|TEST Arm|"Subjects assigned to this arm of the study will receive PGS testing.~24 Chromosome Aneuploidy Screening with Parental Support: Preimplantation Genetic Screening (PGS)"
862941|NCT01194531|E1|Reported Event|CONTROL Arm|Subjects assigned to this arm of the study will receive no PGS testing.
862942|NCT01194479|B3|Baseline|Total|Total of all reporting groups
862943|NCT01194479|B2|Baseline|Type 1 Diabetics|"The active group were participants with type 1 diabetes.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
862944|NCT01194479|B1|Baseline|Healthy Volunteers|"The control group were participants without diabetes, matched by sex, age and BMI to the active comparator group.~Formoterol: Formoterol inhaler, 12mcg capsules, 4 capsules for one administration~Placebo: Participants in both arms received placebo on 1 of the 2 visits."
862945|NCT01194479|P4|Participant Flow|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol first, then Placebo.
862946|NCT01194479|P3|Participant Flow|Type 1 Diabetics: Placebo|Type 1 Diabetics that received Placebo first, then Formoterol.
862947|NCT01194479|P2|Participant Flow|Control: Formoterol|Healthy volunteers that received Formoterol first, then Placebo.
862948|NCT01194479|P1|Participant Flow|Control: Placebo|Healthy volunteers that received Placebo first, the Formoterol.
862949|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
862950|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
862951|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
862952|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
862953|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
862954|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
862955|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
862956|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
862957|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
862958|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
862959|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
862960|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
862961|NCT01194479|O4|Outcome|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first or second visit.
862962|NCT01194479|O3|Outcome|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first or second visit.
862963|NCT01194479|O2|Outcome|Control: Formoterol|Healthy volunteers that received Formoterol on the first or second visit.
862964|NCT01194479|O1|Outcome|Control: Placebo|Healthy volunteers that received Placebo on the first or second visit.
862965|NCT01194479|E4|Reported Event|Type 1 Diabetics: Formoterol|Type 1 Diabetics that received Formoterol on the first visit.
862966|NCT01194479|E3|Reported Event|Type 1 Diabetics: Placebo|Type 1 Diabetics that received placebo on the first visit.
862967|NCT01194479|E2|Reported Event|Control: Formoterol|Healthy volunteers that received Formoterol on the first visit.
862968|NCT01194479|E1|Reported Event|Control: Placebo|Healthy volunteers that received Placebo on the first visit.
862969|NCT01194453|B3|Baseline|Total|Total of all reporting groups
862970|NCT01194453|B2|Baseline|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
862971|NCT01194453|B1|Baseline|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
862972|NCT01194453|P2|Participant Flow|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
862973|NCT01194453|P1|Participant Flow|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
862974|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
862975|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
862976|NCT01194453|O2|Outcome|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
862977|NCT01194453|O1|Outcome|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
917331|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
862978|NCT01194453|E2|Reported Event|Group B|cisplatin, gemcitabine: cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
862979|NCT01194453|E1|Reported Event|Group A|cisplatin, dexamethasone,vitamin B12, folic acid: Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
862980|NCT01194440|B1|Baseline|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
862981|NCT01194440|P1|Participant Flow|Arm I - IV Zoledronic Acid Prophylaxis|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
862982|NCT01194440|O1|Outcome|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
862983|NCT01194440|E1|Reported Event|Arm I|"Patients receive zoledronic acid IV at months 1 and 6. Beginning 14 days after first zoledronic acid infusion, patients receive oral letrozole once daily for 12 months in the absence of disease progression or unacceptable toxicity.~letrozole: Given orally~zoledronic acid: Given IV~laboratory biomarker analysis: Correlative studies~enzyme-linked immunosorbent assay: Correlative studies~mass spectrometry: Correlative studies~bone scan: Correlative studies~quality-of-life assessment: Ancillary studies~questionnaire administration: Ancillary studies~pharmacogenomic studies: Correlative studies~high performance liquid chromatography: Correlative studies"
862984|NCT01194427|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
862985|NCT01194427|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
862986|NCT01194427|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
862987|NCT01194427|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and tamoxifen are taken for about 14 days prior to definitive surgery.
862988|NCT01194414|B3|Baseline|Total|Total of all reporting groups
862989|NCT01194414|B2|Baseline|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863102|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
862990|NCT01194414|B1|Baseline|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
862991|NCT01194414|P4|Participant Flow|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
862992|NCT01194414|P3|Participant Flow|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
862993|NCT01194414|P2|Participant Flow|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
862994|NCT01194414|P1|Participant Flow|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
862995|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
862996|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
862997|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
862998|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
862999|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863000|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863001|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863002|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863003|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863004|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863005|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863155|NCT01194154|B2|Baseline|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863006|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863007|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863008|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863009|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863010|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863011|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863012|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863013|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863014|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863015|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863016|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863017|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863018|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863019|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863020|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863021|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863022|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863023|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863024|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863025|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863026|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863027|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863028|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863029|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863030|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863031|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863032|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863033|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863034|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863035|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863036|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863037|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863038|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863039|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863040|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863061|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
863041|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863042|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863043|NCT01194414|O4|Outcome|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection once a week in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863044|NCT01194414|O3|Outcome|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab IV infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863045|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863046|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863376|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863047|NCT01194414|O2|Outcome|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863048|NCT01194414|O1|Outcome|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose beginning at least 8 weeks prior to baseline were a requirement of the study."
863049|NCT01194414|E4|Reported Event|Tocilizumab IV Then Tocilizumab SC|"Participants who received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly in double blind treatment period switched to tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose will be continued throughout the study."
863050|NCT01194414|E3|Reported Event|Tocilizumab SC Then Tocilizumab IV|"Participants who received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for 24 weeks in double blind treatment period switched to tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863051|NCT01194414|E2|Reported Event|Tocilizumab IV|"Participants received tocilizumab 8 mg/kg infusion (IV) every 4 weeks plus placebo to tocilizumab SC injection weekly for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 8 mg/kg IV infusion every 4 weeks for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863052|NCT01194414|E1|Reported Event|Tocilizumab SC|"Participants received tocilizumab 162 mg subcutaneous (SC) injection weekly plus placebo to tocilizumab intravenous (IV) infusion every 4 weeks for a total of 24 weeks in the double-blind period. Participants continued to receive tocilizumab 162 mg SC injection weekly for a total of 72 weeks in open label extension period.~Non-biologic disease-modifying anti-rheumatic drugs (DMARDs) at a stable dose continued throughout the study."
863053|NCT01194297|B3|Baseline|Total|Total of all reporting groups
863054|NCT01194297|B2|Baseline|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
863055|NCT01194297|B1|Baseline|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
863056|NCT01194297|P2|Participant Flow|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
863057|NCT01194297|P1|Participant Flow|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
863058|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
863059|NCT01194297|O1|Outcome|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
863060|NCT01194297|O2|Outcome|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
863062|NCT01194297|E2|Reported Event|Live Attenuated Influenza Vaccine|"One dose of live attenuated influenza vaccine, according to routine immunization recommendations~Live attenuated influenza vaccine : One dose of live attenuated influenza vaccine, according to routine immunization recommendations"
863063|NCT01194297|E1|Reported Event|Inactivated Influenza Vaccine|"One dose of inactivated influenza vaccine, according to routine immunization recommendations~Inactivated influenza vaccine : One dose of inactivated influenza vaccine, according to routine immunization recommendations"
863064|NCT01194258|B1|Baseline|All Study Participants|All participants in the study, including those who were enrolled but were not randomized.
863065|NCT01194258|P5|Participant Flow|Aspart-PH20, Then Insulin Lispro|"Participants received SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (Aspart-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
863066|NCT01194258|P4|Participant Flow|Insulin Lispro, Then Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin aspart and 5 µg rHuPH20 (combined: Aspart-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
863067|NCT01194258|P3|Participant Flow|Lispro-PH20, Then Insulin Lispro|"Participants received a SC injection of 100 U/mL insulin lispro and 5 µg rHuPH20 (Lispro-PH20) pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 2 of the study."
863068|NCT01194258|P2|Participant Flow|Insulin Lispro, Then Lispro-PH20|"Participants received a subcutaneous (SC) injection of 100 units per milliliter (U/mL) insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 of the study.~Then, participants received a SC injection of 100 U insulin lispro and 5 micrograms (µg) recombinant human hyaluronidase PH20 (rHuPH20) (combined: Lispro-PH20) pre-meals for 12 weeks during Treatment Period 2 of the study."
863125|NCT01194219|P1|Participant Flow|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
864313|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
863069|NCT01194258|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 U/mL insulin glulisine, injected SC, pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863070|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863071|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863072|NCT01194258|O2|Outcome|Insulin-lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863073|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (Insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863074|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863075|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863076|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863077|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863078|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863079|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863080|NCT01194258|O2|Outcome|Insulin Lispro|100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863081|NCT01194258|O1|Outcome|Analog-PH20|100 U/mL insulin analog (insulin lispro or insulin aspart) with 5.0 µg/mL rHuPH20, injected SC, pre-meals, with doses titrated to each participant individually, for 12 weeks
863082|NCT01194258|E5|Reported Event|Aspart-PH20|"Participants received a SC injection of 100 U/mL insulin aspart and 5 μg rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863083|NCT01194258|E4|Reported Event|Insulin Lispro (Aspart-PH20 Cohort)|"Participants randomized to the Aspart-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863084|NCT01194258|E3|Reported Event|Lispro-PH20|"Participants received a SC injection of 100 U/mL insulin lispro with 5 micrograms (μg) rHuPH20 pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863085|NCT01194258|E2|Reported Event|Insulin Lispro (Lispro-PH20 Cohort)|"Participants randomized to the Lispro-PH20 cohort.~Participants received a SC injection of 100 U/mL insulin lispro alone pre-meals for 12 weeks during Treatment Period 1 or 2 of the study.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863086|NCT01194258|E1|Reported Event|Titration Period|Prior to randomization, all enrolled participants underwent a titration period of 4 to 6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.
863087|NCT01194245|B6|Baseline|Total|Total of all reporting groups
863100|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863101|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863088|NCT01194245|B5|Baseline|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863089|NCT01194245|B4|Baseline|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863090|NCT01194245|B3|Baseline|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
864314|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
863091|NCT01194245|B2|Baseline|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863092|NCT01194245|B1|Baseline|Non-randomized Participants|"Participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually. Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine.~Participants did not complete the titration period or did not meet one or more randomization criteria and, therefore, were not randomized."
863093|NCT01194245|P5|Participant Flow|Insulin Lispro First, Then Aspart-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Aspart-PH20 (Treatment A): 100 U/mL insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863094|NCT01194245|P4|Participant Flow|Aspart-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Aspart-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863095|NCT01194245|P3|Participant Flow|Insulin Lispro First, Then Lispro-PH20|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Lispro-PH20 (Treatment A): 100 U/mL insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863096|NCT01194245|P2|Participant Flow|Lispro-PH20 First, Then Insulin Lispro|"Following a titration period of 4 to 6 weeks, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~Lispro-PH20 (Treatment A): 100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, with doses titrated to each participant individually~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863097|NCT01194245|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863098|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863099|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
880856|NCT01146457|O2|Outcome|Morphine 25|Morphine 25 micrograms
863103|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863104|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863105|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863106|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863107|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863108|NCT01194245|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863109|NCT01194245|O1|Outcome|Analog-PH20|100 units per milliliter (U/mL) insulin lispro or insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, for 12 weeks, with doses titrated to each participant individually
863126|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (Weeks 0-16)
863127|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
863110|NCT01194245|E5|Reported Event|Insulin Lispro (Aspart-PH20 Cohort) Treatment Period|"Participants were randomized to the Aspart-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863111|NCT01194245|E4|Reported Event|Aspart-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin aspart with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863112|NCT01194245|E3|Reported Event|Insulin Lispro (Lispro-PH20 Cohort) Treatment Period|"Participants were randomized to the Lispro-PH20 cohort.~100 units per milliliter (U/mL) insulin lispro, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863113|NCT01194245|E2|Reported Event|Lispro-PH20 Treatment Period|"100 units per milliliter (U/mL) insulin lispro with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863114|NCT01194245|E1|Reported Event|Titration Period (All Enrolled Participants)|"Prior to randomization, all enrolled participants underwent a titration period of 4-6 weeks in which they received 100 units per milliliter (U/mL) insulin glulisine, injected subcutaneously (SC), pre-meals, with doses titrated to each participant individually.~Participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine."
863115|NCT01194219|B3|Baseline|Total|Total of all reporting groups
863116|NCT01194219|B2|Baseline|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
863117|NCT01194219|B1|Baseline|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
863118|NCT01194219|P8|Participant Flow|PBO-APR-APR + Optional Topicals/ UVB|Participants who were initially randomized to placebo BID during the 16-week Placebo-controlled Phase (weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and those participants who were considered non-responders (ie, having a response of < PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. A subset of these partial or non-responders received additional topical or phototherapy. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 ans remained on APR 30 mg BID for the remainder of their participation.
863119|NCT01194219|P7|Participant Flow|APR-APR-APR + Optional Topicals/UVB|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered partial responders (ie, having a response of PASI-50 to PASI-74) and those participants who were considered non-responders (ie, having a response of <PASI-50), remained on APR 30 mg BID and were given the option of adding topical therapies and/or phototherapy to their regimen. Those participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
863120|NCT01194219|P6|Participant Flow|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR during the Randomized Withdrawal Phase (weeks 32-52). Those participants who completed the Randomized Withdrawal Phase at Week 52 were eligible to participate in the Long-term Extension Phase from Weeks 52-260 and remained on APR 30 mg BID for the remainder of their participation.
863151|NCT01194219|E3|Reported Event|APR-APR-PBO: Weeks 32-52|Participants re-randomized to placebo tablets BID at Week 32. Includes data from Week 32 up to Week 52 when participants received placebo treatment.
863152|NCT01194219|E2|Reported Event|Placebo: Weeks 0-16|Participants randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
863153|NCT01194219|E1|Reported Event|Apremilast: Weeks 0-16|Participants randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16)
863154|NCT01194154|B3|Baseline|Total|Total of all reporting groups
863412|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863121|NCT01194219|P5|Participant Flow|APR-APR-Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At week 32, those participants who were considered responders [ie, having a ≥ Psoriasis Area and Severity Index score of 75 (PASI-75) response] were re-randomized to PBO during the Randomized Withdrawal Phase (weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed. All participants who completed the Randomized Withdrawal Phase at week 52 were eligible to participate in the Long-term Extension Phase from weeks 52-260, and received APR 30 mg BID for the remainder of their participation.
863122|NCT01194219|P4|Participant Flow|Placebo-Apremilast|Participants who were initially randomized to identically matching PBO BID during the Placebo-controlled Phase (weeks 0-16) were switched after 16 weeks of treatment to APR 30 mg BID and continued dosing with APR 30 mg BID during the Maintenance Phase (weeks 16-32)
863123|NCT01194219|P3|Participant Flow|Apremilast-Apremilast|Participants who were initially randomized to APR 30 mg tablets BID during the Placebo-controlled Phase (Weeks 0-16) remained on APR 30 mg BID during the Maintenance Phase (Weeks 16-32).
863124|NCT01194219|P2|Participant Flow|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
863343|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863128|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo tablets BID during the Placebo-controlled Phase (weeks 0-16)
863129|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
863130|NCT01194219|O2|Outcome|APR-APR -Re-randomized to PBO|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to PBO during the Randomized Withdrawal Phase (Weeks 32-52). Those participants who retained their ≥PASI-75 response through the Randomized Withdrawal Phase remained on PBO until Week 52. Those participants who lost their PASI-75 improvement achieved at Week 32, were switched back to APR 30 mg BID at the time loss of effect was observed.
863131|NCT01194219|O1|Outcome|APR-APR-Re-randomized to APR|Participants who were initially randomized to APR 30 mg BID during the 16-week Placebo-controlled Phase continued dosing with APR 30 mg BID through the Maintenance Phase (Weeks 16-32). At Week 32, those participants who were considered responders (ie, having a ≥PASI-75 response) were re-randomized to APR during the Randomized Withdrawal Phase (Weeks 32-52).
863132|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (Weeks 0-16)
863133|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
863134|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16).
863135|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
863136|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
863137|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
863138|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
863139|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
863140|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
863141|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
863142|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
863143|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
863144|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching PBO tablets BID during the Placebo-controlled Phase (weeks 0-16)
863145|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
863146|NCT01194219|O2|Outcome|Placebo|Participants were initially randomized to identically matching placebo (PBO) tablets BID during the Placebo-controlled Phase (weeks 0-16)
863147|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast 30mg tablets BID during the Placebo-controlled Phase (weeks 0-16)
863148|NCT01194219|O2|Outcome|Placebo (PBO)|Participants were initially randomized to identically matching placebo (PBO) tablets twice daily BID during the Placebo-controlled Phase (Weeks 0-16)
863149|NCT01194219|O1|Outcome|Apremilast|Participants were initially randomized to apremilast (APR) 30 mg tablets twice daily (BID) during the Placebo-controlled Phase (Weeks 0-16)
863150|NCT01194219|E4|Reported Event|Weeks 0-52: APR-Exposure Period|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0 or at week 16), up until Week 52. Adverse events associated with 30 mg apremilast treatment up to Week 52 were included.
863156|NCT01194154|B1|Baseline|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
863157|NCT01194154|P2|Participant Flow|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863158|NCT01194154|P1|Participant Flow|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
863159|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863160|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
863161|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863162|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/ dL.
863163|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863164|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
863165|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
864315|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
863166|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
863167|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863168|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
863169|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863170|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
863171|NCT01194154|O2|Outcome|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863172|NCT01194154|O1|Outcome|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
863173|NCT01194154|E2|Reported Event|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
863174|NCT01194154|E1|Reported Event|Mircera|Methoxy polyethylene glycol-epoetin beta 30 mcg subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 g/dL.
863175|NCT01194089|B3|Baseline|Total|Total of all reporting groups
863176|NCT01194089|B2|Baseline|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
863177|NCT01194089|B1|Baseline|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
863178|NCT01194089|P2|Participant Flow|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
863179|NCT01194089|P1|Participant Flow|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
863180|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
863181|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
863182|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
863183|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
863184|NCT01194089|O2|Outcome|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
863185|NCT01194089|O1|Outcome|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
863186|NCT01194089|E2|Reported Event|Nasal Normal Saline Spray|1 ml of nasal normal saline spray will be administered postoperatively.
863187|NCT01194089|E1|Reported Event|Nasal Nicotine Spray|3 mg of nasal nicotine will be administered postoperatively.
863188|NCT01193920|B11|Baseline|Total|Total of all reporting groups
863189|NCT01193920|B10|Baseline|Infants / Placebo|Infants born from women who received one injection of saline solution
863190|NCT01193920|B9|Baseline|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863191|NCT01193920|B8|Baseline|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863192|NCT01193920|B7|Baseline|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863193|NCT01193920|B6|Baseline|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863194|NCT01193920|B5|Baseline|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863195|NCT01193920|B4|Baseline|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863196|NCT01193920|B3|Baseline|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863197|NCT01193920|B2|Baseline|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
863198|NCT01193920|B1|Baseline|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863199|NCT01193920|P10|Participant Flow|Infants / Placebo|Infants born from women who received saline solution
863200|NCT01193920|P9|Participant Flow|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863201|NCT01193920|P8|Participant Flow|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863202|NCT01193920|P7|Participant Flow|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863203|NCT01193920|P6|Participant Flow|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863204|NCT01193920|P5|Participant Flow|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863205|NCT01193920|P4|Participant Flow|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863206|NCT01193920|P3|Participant Flow|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863207|NCT01193920|P2|Participant Flow|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
863208|NCT01193920|P1|Participant Flow|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863209|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
863210|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863211|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863212|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863213|NCT01193920|O4|Outcome|Infants / Placebo|Infants born from women who received saline solution
863214|NCT01193920|O3|Outcome|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863215|NCT01193920|O2|Outcome|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863216|NCT01193920|O1|Outcome|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863217|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863218|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863219|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863220|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863221|NCT01193920|O2|Outcome|Non Pregnant/Placebo|Non pregnant women received two injections of saline solution
863222|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863223|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
863224|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863225|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
863226|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863227|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863228|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863229|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863230|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863231|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863232|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863233|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863234|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863235|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863236|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863237|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863238|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863239|NCT01193920|O4|Outcome|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863240|NCT01193920|O3|Outcome|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863241|NCT01193920|O2|Outcome|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863242|NCT01193920|O1|Outcome|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863243|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
863244|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863245|NCT01193920|O2|Outcome|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
863246|NCT01193920|O1|Outcome|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863247|NCT01193920|E10|Reported Event|Infants / Placebo|Infants born from women who received one injection of saline solution
863248|NCT01193920|E9|Reported Event|Infants 5/5/5 μg|Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863249|NCT01193920|E8|Reported Event|Infants 2.5/2.5/2.5 μg|Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863250|NCT01193920|E7|Reported Event|Infants 0.5/0.5/0.5 μg|Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863251|NCT01193920|E6|Reported Event|Pregnant/Placebo|Pregnant women who received one injection of saline solution
863252|NCT01193920|E5|Reported Event|Pregnant 5/5/5 μg|Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
863253|NCT01193920|E4|Reported Event|Pregnant 2.5/2.5/2.5 μg|Pregnant women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
863254|NCT01193920|E3|Reported Event|Pregnant 0.5/0.5/0.5 μg|Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
863255|NCT01193920|E2|Reported Event|Non-pregnant/Placebo|Non-pregnant women received two injections of saline solution
863375|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863256|NCT01193920|E1|Reported Event|Non-pregnant 20/20/20 μg +Aluminum Hydroxide|Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
863257|NCT01193907|B5|Baseline|Total|Total of all reporting groups
863258|NCT01193907|B4|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
863259|NCT01193907|B3|Baseline|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
863260|NCT01193907|B2|Baseline|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
863261|NCT01193907|B1|Baseline|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
863262|NCT01193907|P4|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
863263|NCT01193907|P3|Participant Flow|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
863264|NCT01193907|P2|Participant Flow|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
863265|NCT01193907|P1|Participant Flow|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
863266|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
863267|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
863268|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
863269|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
863270|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
863271|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
863272|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
863273|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
863274|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
863275|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
863276|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
863277|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
863278|NCT01193907|O4|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
863279|NCT01193907|O3|Outcome|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
863280|NCT01193907|O2|Outcome|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
863281|NCT01193907|O1|Outcome|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
863282|NCT01193907|E4|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-PS
863283|NCT01193907|E3|Reported Event|NVGH Vi-CRM197 1.25 Mcg|1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
863284|NCT01193907|E2|Reported Event|NVGH Vi-CRM197 5.0 Mcg|1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
863285|NCT01193907|E1|Reported Event|NVGH Vi-CRM197 12.5 Mcg|1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
863286|NCT01193868|B1|Baseline|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863287|NCT01193868|P1|Participant Flow|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863288|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863289|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863290|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863291|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863292|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863293|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863294|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863295|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863296|NCT01193868|O1|Outcome|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
880857|NCT01146457|O1|Outcome|Control|Saline Control
863297|NCT01193868|E1|Reported Event|RO4929097|Oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days
863298|NCT01193686|B3|Baseline|Total|Total of all reporting groups
863299|NCT01193686|B2|Baseline|Recipients of Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and were initiating rehabilitation therapies.
863300|NCT01193686|B1|Baseline|Veteran Peer Visitors|Veterans who seved in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabiliation were recruited for training as peer mentors.
863301|NCT01193686|P2|Participant Flow|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
863302|NCT01193686|P1|Participant Flow|Veteran Peer Visitors|Of the 15 (52%) PV who enrolled in the study and completed the baseline assessment, 4 (27%) withdrew prior to PV training due to moving out of state (3) or schedule limitations (n=1). One was removed from the study by investigators due to discovery of invalid reporting.
863303|NCT01193686|O2|Outcome|Recipients of PV|
863304|NCT01193686|O1|Outcome|Veteran Peer Visitors|
863305|NCT01193686|O2|Outcome|Recipients of PV|
863306|NCT01193686|O1|Outcome|Veteran Peer Visitors|
863307|NCT01193686|O2|Outcome|Recipients of PV|
863308|NCT01193686|O1|Outcome|Veteran Peer Visitors|
863309|NCT01193686|O2|Outcome|Recipients of PV|
863310|NCT01193686|O1|Outcome|Veteran Peer Visitors|
863311|NCT01193686|O2|Outcome|Recipients of PV|9 Veterans receiving care at a Polytrauma Network Site (of over 300 seen during the study period) expressed interest in meeting with a Veteran Peer Mentor. Of these 8 completed visits and all study requirements. One withdrew for non-study-related reasons.
863312|NCT01193686|O1|Outcome|Veteran Peer Visitors|
863313|NCT01193686|E2|Reported Event|Recipients of Veteran Peer Visitation|Veterans of Operation Enduring Freedom or Operation Iraqi Freedom who sustained polytrauma (i.e., mutiple systems involved) injuries.
863314|NCT01193686|E1|Reported Event|Veteran Peer Visitors|Veteran Peer Visitors (VPV) who participated in a 2-day training program and then provided at 1-5 visits to at least 2 recipients. All Peer Visitors had served in Operation Iraqi Freedom or Operation Enduring Freedom, sustained polytrauma injuries, and successfully completed rehabilitation.
863315|NCT01193660|B4|Baseline|Total|Total of all reporting groups
863316|NCT01193660|B3|Baseline|Only Rehabilitation|Active rehabilitation
863317|NCT01193660|B2|Baseline|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863318|NCT01193660|B1|Baseline|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863319|NCT01193660|P3|Participant Flow|Only Rehabilitation|Active rehabilitation
863320|NCT01193660|P2|Participant Flow|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863321|NCT01193660|P1|Participant Flow|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863322|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863323|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863324|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863325|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863326|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863327|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863328|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863329|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863330|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863331|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863332|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863333|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863334|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863413|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863335|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863336|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863337|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863338|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863339|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863340|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863341|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863342|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863344|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863345|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863346|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863347|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863348|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863349|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863350|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863351|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863352|NCT01193660|O3|Outcome|Only Rehabilitation|Active rehabilitation
863353|NCT01193660|O2|Outcome|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863354|NCT01193660|O1|Outcome|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863355|NCT01193660|E3|Reported Event|Only Rehabilitation|Active rehabilitation
863356|NCT01193660|E2|Reported Event|Erythropoietin & Rehabilitation|Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times),and active rehabilitation
863357|NCT01193660|E1|Reported Event|Umbilical Cord Blood & Erythropoietin & Rehabilitation|Allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg intravenously), Erythropoietin injection (twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times), and active rehabilitation
863358|NCT01193608|B7|Baseline|Total|Total of all reporting groups
863359|NCT01193608|B6|Baseline|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863360|NCT01193608|B5|Baseline|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863361|NCT01193608|B4|Baseline|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863362|NCT01193608|B3|Baseline|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863363|NCT01193608|B2|Baseline|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863364|NCT01193608|B1|Baseline|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863365|NCT01193608|P6|Participant Flow|Placebo|Participants received placebo matched to AAB-003 1-hour IV infusion (infusion of placebo matched to AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
863366|NCT01193608|P5|Participant Flow|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
863414|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863415|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863367|NCT01193608|P4|Participant Flow|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
863368|NCT01193608|P3|Participant Flow|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
863369|NCT01193608|P2|Participant Flow|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg 1-hour IV infusion (infusion of AAB-003 and 20 mL normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
863370|NCT01193608|P1|Participant Flow|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 milligram/kilogram (mg/kg) 1-hour intravenous (IV) infusion (infusion of AAB-003 and 20 milliliter (mL) normal saline flush of IV line) once every 13 weeks on Day 1, Week 13 and Week 26 for a total of 3 infusions over the course of study. A final follow-up visit was performed at Week 39, 13 weeks after the last infusion.
863371|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863372|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863373|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863374|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863377|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863378|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863379|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863380|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863381|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863382|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863383|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863384|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863385|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863386|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863387|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863388|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863389|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863390|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863391|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863392|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863393|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863394|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863395|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863396|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863397|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863398|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863399|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863400|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863401|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863402|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863403|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863404|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863405|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863406|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863407|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863408|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863409|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863410|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863411|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863416|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863417|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863418|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863419|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863420|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863421|NCT01193608|O2|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863422|NCT01193608|O1|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863423|NCT01193608|O3|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863424|NCT01193608|O2|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863425|NCT01193608|O1|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863426|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863427|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863428|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863429|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863430|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863431|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863432|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863433|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863434|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863435|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863436|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863437|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863438|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863439|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863440|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863441|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863442|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863443|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863444|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863445|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863446|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863447|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863448|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863449|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863450|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863451|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863452|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863453|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863454|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863455|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863456|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863457|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863458|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863459|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863460|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863461|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863462|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863463|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863464|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863465|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863466|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863467|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863468|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863469|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863470|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863471|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863472|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863473|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863474|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863475|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863476|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863477|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863478|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863479|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863480|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863481|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863482|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863483|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863484|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863485|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863486|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863487|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863488|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863489|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863490|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863491|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863492|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863493|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863494|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863495|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863496|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863497|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863498|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863499|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863500|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863501|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863502|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863503|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863504|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863505|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863506|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863507|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863508|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863509|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863510|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863511|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863512|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863513|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863514|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863515|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863516|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863517|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
880858|NCT01146457|E5|Reported Event|Morphine 100|Morphine: Active dosage
863518|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863519|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863520|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863521|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863522|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863523|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863524|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863525|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863526|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863527|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863528|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863529|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863530|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863531|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863532|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863533|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863534|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863535|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863536|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863537|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863538|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863539|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863540|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863541|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863542|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863543|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863544|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863545|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863546|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863547|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863548|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863549|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863550|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863551|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863552|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863553|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863554|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863555|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863556|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863557|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863558|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863559|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863560|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863561|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863562|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863563|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863564|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863565|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863566|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863567|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863568|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
880859|NCT01146457|E4|Reported Event|Morphine 75|Morphine: Active dosage
863569|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863570|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863571|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863572|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863573|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863574|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863575|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863576|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863577|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863578|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863579|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863580|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863581|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863582|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863583|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863584|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863585|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863586|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863587|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863588|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863589|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863590|NCT01193608|O6|Outcome|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863591|NCT01193608|O5|Outcome|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863592|NCT01193608|O4|Outcome|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863593|NCT01193608|O3|Outcome|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863594|NCT01193608|O2|Outcome|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863595|NCT01193608|O1|Outcome|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863596|NCT01193608|E6|Reported Event|Placebo|Participants received placebo matched to AAB-003 by IV infusion on Day 1, Week 13 and Week 26
863597|NCT01193608|E5|Reported Event|AAB-003 8 mg/kg|Participants received AAB-003 8 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863598|NCT01193608|E4|Reported Event|AAB-003 4 mg/kg|Participants received AAB-003 4 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863599|NCT01193608|E3|Reported Event|AAB-003 2 mg/kg|Participants received AAB-003 2 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863600|NCT01193608|E2|Reported Event|AAB-003 1 mg/kg|Participants received AAB-003 1 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863601|NCT01193608|E1|Reported Event|AAB-003 0.5 mg/kg|Participants received AAB-003 0.5 mg/kg by IV infusion on Day 1, Week 13 and Week 26
863602|NCT01193582|B5|Baseline|Total|Total of all reporting groups
863603|NCT01193582|B4|Baseline|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
863604|NCT01193582|B3|Baseline|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863605|NCT01193582|B2|Baseline|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863606|NCT01193582|B1|Baseline|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863607|NCT01193582|P4|Participant Flow|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
863608|NCT01193582|P3|Participant Flow|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863609|NCT01193582|P2|Participant Flow|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863610|NCT01193582|P1|Participant Flow|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863611|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
863612|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863613|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863614|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863615|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
863616|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863617|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863618|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863619|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863620|NCT01193582|O1|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863621|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863622|NCT01193582|O1|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863623|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863624|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863625|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
863626|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863627|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863628|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863629|NCT01193582|O4|Outcome|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar.
863630|NCT01193582|O3|Outcome|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863631|NCT01193582|O2|Outcome|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863632|NCT01193582|O1|Outcome|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863633|NCT01193582|E4|Reported Event|Group 4|Participants 24 to <72 months of age (before the sixth birthday) and received 1 dose of Prevenar
863634|NCT01193582|E3|Reported Event|Group 3|Participants 12 to <24 months of age (before the second birthday) and received 2 doses of Prevenar
863843|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
863635|NCT01193582|E2|Reported Event|Group 2|Participants 212 days to <12 months of age (before the first birthday) and received 3 doses of Prevenar.
863636|NCT01193582|E1|Reported Event|Group 1|Participants 121 to <212 days of age and received 4 doses of Prevenar.
863637|NCT01193556|B3|Baseline|Total|Total of all reporting groups
863638|NCT01193556|B2|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
863639|NCT01193556|B1|Baseline|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
863640|NCT01193556|P2|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
863641|NCT01193556|P1|Participant Flow|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
863642|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
863643|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
863644|NCT01193556|O2|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
863645|NCT01193556|O1|Outcome|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
863646|NCT01193556|E2|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the tonsillectomy.
863647|NCT01193556|E1|Reported Event|Standard of Care (SOC)|Traditional electrosurgery will be used for the tonsillectomy.
863648|NCT01193348|B1|Baseline|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863649|NCT01193348|P1|Participant Flow|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863650|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|≥40kg weight cohort
863651|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|30 – <40kg weight cohort
863652|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|20 – <30kg weight cohort
863653|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|10 – <20kg weight cohort
863654|NCT01193348|O1|Outcome|Eculizumab. Min and Max Blood Concentration|5 – <10kg weight cohort
863655|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863656|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863657|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863658|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863659|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863660|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863661|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863662|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863663|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863664|NCT01193348|O1|Outcome|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863665|NCT01193348|E1|Reported Event|Eculizumab|Eculizumab: Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
863666|NCT01193335|B3|Baseline|Total|Total of all reporting groups
863667|NCT01193335|B2|Baseline|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863690|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863668|NCT01193335|B1|Baseline|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863669|NCT01193335|P2|Participant Flow|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863670|NCT01193335|P1|Participant Flow|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863671|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863672|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863673|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
864316|NCT01193049|E2|Reported Event|Placebo|All participants who received at least one dose of placebo
863674|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863675|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863676|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863677|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863678|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863679|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863680|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863681|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863682|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863683|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863684|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863685|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863686|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863687|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863688|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863689|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863691|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863692|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863693|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863694|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863695|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863696|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863697|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863698|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863699|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863844|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
863700|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863701|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863702|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863703|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863704|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863705|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863706|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863707|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863708|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863709|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863710|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863711|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863712|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863713|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863714|NCT01193335|O3|Outcome|13vPnC (Group 1C)|Preterm infant participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863715|NCT01193335|O2|Outcome|13vPnC (Group 1B)|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863716|NCT01193335|O1|Outcome|13vPnC (Group 1A)|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863717|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863718|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
880860|NCT01146457|E3|Reported Event|Morphine 50|Morphine: Active dosage
863719|NCT01193335|O3|Outcome|13vPnC Group 1C|Preterm participants with GA <29 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863720|NCT01193335|O2|Outcome|13vPnC Group 1B|Preterm infant participants with GA >=29 weeks and <32 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863721|NCT01193335|O1|Outcome|13vPnC Group 1A|Preterm infant participants with GA >=32 weeks and <37 weeks received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863722|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863723|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (GA <37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA >=32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863724|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863744|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863845|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
863725|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863726|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863727|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863728|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863729|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863730|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863731|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863732|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863733|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863734|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863735|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863736|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863737|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863738|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863739|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863924|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863740|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863741|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863742|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863743|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863846|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
863745|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863746|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863747|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863748|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863749|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863750|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863751|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863752|NCT01193335|O2|Outcome|13vPnC Group 2 (Term Infant)|Term infant participants (GA >=37 weeks) received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose).
863753|NCT01193335|O1|Outcome|13vPnC Group 1 (Preterm Infant)|Preterm infant participants (gestational age [GA] less than [<] 37 weeks) received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly at 2, 3, 4 months of age (infant series) and at 12 months of age (toddler dose). Preterm infant group was subdivided into Group 1A (GA greater than or equal to [>=] 32 weeks and <37 weeks), Group 1B (GA >=29 weeks and <32 weeks) and Group 1C (GA <29 weeks).
863754|NCT01193335|E10|Reported Event|13vPnC Group 2 (Term Infant) - 2 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
863755|NCT01193335|E9|Reported Event|13vPnC Group 1 (Preterm Infant) - 2 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from 1-year follow-up after toddler dose to 2-year follow-up after toddler dose.
863756|NCT01193335|E8|Reported Event|13vPnC Group 2 (Term Infant) - 1 Year Follow-up|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
863757|NCT01193335|E7|Reported Event|13vPnC Group 1 (Preterm Infant) - 1 Year Follow-up|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from blood draw 1 month after the toddler dose to 1-year follow-up.
863758|NCT01193335|E6|Reported Event|13vPnC Group 2 (Term Infant) - Toddler Dose|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
863759|NCT01193335|E5|Reported Event|13vPnC Group 1 (Preterm Infant) - Toddler Dose|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series) and 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after toddler dose.
863925|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
880861|NCT01146457|E2|Reported Event|Morphine 25|Morphine: Active dosage
863760|NCT01193335|E4|Reported Event|13vPnC Group 2 (Term Infant) - After Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
863761|NCT01193335|E3|Reported Event|13vPnC Group 1 (Preterm Infant) - After Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from blood draw 1 month after infant Dose 3 to before toddler dose.
863762|NCT01193335|E2|Reported Event|13vPnC Group 2 (Term Infant) - Infant Series|Term infant participants (GA >=37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3, 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
863763|NCT01193335|E1|Reported Event|13vPnC Group 1 (Preterm Infant) - Infant Series|Preterm infant participants (GA <37 weeks) who received single 0.5 mL dose of 13vPnC intramuscularly at 2, 3 and 4 months of age (infant series), assessed from Infant Dose 1 through the blood draw 1 month after Infant Dose 3.
863784|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863808|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863764|NCT01193283|B1|Baseline|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
863765|NCT01193283|P1|Participant Flow|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
863766|NCT01193283|O1|Outcome|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
863767|NCT01193283|E1|Reported Event|SAA Hematologic Response|"Treatment-naive severe aplastic anemia patients will receive a low dose of cyclophosphamide (120mg/kg) and low dose cyclosporine ( target therapeutic level of 100-200 micrograms per liter). Cyclophosphamide will be given once daily for 4 doses. Cyclosporine will be started after cyclophosphamide completion, cyclosporine will be given twice daily. The dosing will be modified to attain the therapeutic level.~Cyclophosphamide: 30 my/kg for 4 days~Cyclosporine: daily to a trough of 100 t0 200 ng/ml"
863768|NCT01193244|B3|Baseline|Total|Total of all reporting groups
863769|NCT01193244|B2|Baseline|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863770|NCT01193244|B1|Baseline|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863771|NCT01193244|P2|Participant Flow|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863772|NCT01193244|P1|Participant Flow|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863773|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863774|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863775|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863776|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863777|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863778|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863779|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863780|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
864291|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
863781|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863782|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863783|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863842|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
863785|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863786|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863787|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863788|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863789|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863790|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863791|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863792|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863793|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863794|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863795|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863796|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863797|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863798|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863799|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863800|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863801|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863802|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863803|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863804|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863805|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863806|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863807|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863809|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863810|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863811|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863812|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863813|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863814|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863815|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863816|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863817|NCT01193244|O2|Outcome|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863818|NCT01193244|O1|Outcome|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863819|NCT01193244|E2|Reported Event|Orteronel 400 mg + Prednisone 5 mg|Orteronel 400 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study. In Japan, participants were administered with Orteronel 300 mg, tablets, orally, BID and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863820|NCT01193244|E1|Reported Event|Placebo + Prednisone 5 mg|Orteronel placebo-matching tablets, orally, twice daily (BID) and Prednisone 5 mg, tablets, orally, BID for up to Day 28 of each treatment cycle throughout the study.
863821|NCT01193218|B6|Baseline|Total|Total of all reporting groups
863822|NCT01193218|B5|Baseline|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
863823|NCT01193218|B4|Baseline|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
863824|NCT01193218|B3|Baseline|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
863825|NCT01193218|B2|Baseline|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
863826|NCT01193218|B1|Baseline|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
863827|NCT01193218|P8|Participant Flow|Empa 50 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 50 mg/25 mg once daily group in the 40-week second treatment period
863828|NCT01193218|P7|Participant Flow|Empa 50mg\10mg|It is actually empagliflozin 50 mg once daily group in the 12-week first treatment period, and empagliflozin 50 mg/10 mg once daily group in the 40-week second treatment period
863829|NCT01193218|P6|Participant Flow|Empa 25mg|Empagliflozin 25 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
863830|NCT01193218|P5|Participant Flow|Empa 10mg|Empagliflozin 10 mg once daily group both in the 12-week first treatment period and the 40-week second treatment period
863831|NCT01193218|P4|Participant Flow|Empa 5 mg/25 mg|It is actually N/A in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
863832|NCT01193218|P3|Participant Flow|Empa 5mg/10mg|It is actually empagliflozin 5 mg once daily group in the 12-week first treatment period, and empagliflozin 5 mg/25 mg once daily group in the 40-week second treatment period
880862|NCT01146457|E1|Reported Event|Placebo|Saline: Saline Control
863833|NCT01193218|P2|Participant Flow|Placebo/Empa 25 mg|It is actually N/A in the 12-week first treatment period, and placebo/empagliflozin 25 mg once daily group in the 40-week second treatment period
863834|NCT01193218|P1|Participant Flow|Placebo/Empa 10mg|It is actually placebo once daily group in the 12-week first treatment period, and placebo/empagliflozin 10 mg once daily group in the 40-week second treatment period
863835|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
863836|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
863837|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
863838|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
863839|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
863840|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
863841|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
863847|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
863848|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
863849|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
863850|NCT01193218|O5|Outcome|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
863851|NCT01193218|O4|Outcome|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
863852|NCT01193218|O3|Outcome|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
863853|NCT01193218|O2|Outcome|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
863854|NCT01193218|O1|Outcome|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
863855|NCT01193218|E9|Reported Event|Empa 25mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 25 mg once daily for 52−week treatment
863856|NCT01193218|E8|Reported Event|Empa 10mg (With at Least One Dose, 52 Week)|Patients with at least one dose of empagliflozin 10 mg once daily for 52−week treatment
863857|NCT01193218|E7|Reported Event|Empa 25mg (Randomized, 52 Week)|Patients randomized to empagliflozin 25 mg once daily for 52 weeks
863858|NCT01193218|E6|Reported Event|Empa 10mg (Randomized, 52 Week)|Patients randomized to empagliflozin 10mg once daily for 52 weeks
863859|NCT01193218|E5|Reported Event|Empa 50mg (12 Week)|Empagliflozin 50 mg once daily group in the 12-week first treatment period
863860|NCT01193218|E4|Reported Event|Empa 25mg (12 Week)|Empagliflozin 25 mg once daily group in the 12-week first treatment period
863861|NCT01193218|E3|Reported Event|Empa 10mg (12 Week)|Empagliflozin 10 mg once daily group in the 12-week first treatment period
863862|NCT01193218|E2|Reported Event|Empa 5mg (12 Week)|Empagliflozin 5 mg once daily group in the 12-week first treatment period
863863|NCT01193218|E1|Reported Event|Placebo (12 Week)|Placebo once daily group in the 12-week first treatment period
863864|NCT01193153|B1|Baseline|Entire Study Population|Included all participants who received at least 1 dose of paliperidone palmitate in open-label lead in period.
863865|NCT01193153|P2|Participant Flow|Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks during double-blind relapse prevention period.
863866|NCT01193153|P1|Participant Flow|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period. DB Relapse prevention period (15 months): Same dose as Day 92 once every 4 weeks until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863867|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863868|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863869|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
863926|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863927|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863928|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863929|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863870|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863871|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863872|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863873|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
863891|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863947|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863948|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863874|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863875|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863876|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863877|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
863878|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863879|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863880|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863881|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
863882|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863883|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863884|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863885|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863886|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863887|NCT01193153|O2|Outcome|Placebo|Participants did not receive placebo during open-label lead in period and open-label stabilization period.
863930|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863931|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863932|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863933|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863888|NCT01193153|O1|Outcome|Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863889|NCT01193153|O2|Outcome|Placebo|Matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants.
863890|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863946|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863892|NCT01193153|O1|Outcome|Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863893|NCT01193153|E3|Reported Event|Double Blind - Placebo|Participants did not receive placebo during OL lead in period and OL stabilization period. Participants received matching placebo injections of 20 percent Intralipid (200 milligram per milliliter [mg/mL]) emulsion, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants during DB relapse prevention period.
863894|NCT01193153|E2|Reported Event|Double Blind - Paliperidone Palmitate|DB Relapse prevention period (15 months): Same dose as Day 92, once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants, until one of the following occurred: met the prospectively defined relapse criteria; discontinued treatment for a reason other than relapse; withdrew consent; lost to follow-up; completed 15 months of double-blind treatment.
863895|NCT01193153|E1|Reported Event|Open Label - Paliperidone Palmitate|Open Label (OL) Lead-in (13 weeks): 234 milligram (mg) injection on Day 1, 156 mg on Day 8, flexible dose between 78-234 mg on Days 36, 64, and 92, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who met criteria: Positive and Negative Syndrome Scale (PANSS) total score less than or equal to (<=) 70, and Young Mania Rating Scale [YMRS] and Hamilton Rating Scale for Depression [HAM-D-21] <=12 at the end of open label lead-in period entered stabilization period. OL Stabilization (12 weeks): Same dose as Day 92 in OL lead in period, on Day 120 once every 4 weeks, given as monotherapy and as an adjunct to mood stabilizers or antidepressants. Participants who completed stabilization period and maintained stabilization criteria throughout 12 weeks entered double- bind (DB) relapse prevention period.
863896|NCT01193127|B5|Baseline|Total|Total of all reporting groups
863897|NCT01193127|B4|Baseline|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863898|NCT01193127|B3|Baseline|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863899|NCT01193127|B2|Baseline|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863900|NCT01193127|B1|Baseline|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863901|NCT01193127|P4|Participant Flow|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863902|NCT01193127|P3|Participant Flow|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863903|NCT01193127|P2|Participant Flow|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863904|NCT01193127|P1|Participant Flow|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863905|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863906|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863907|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863908|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863909|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863910|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863911|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863912|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863913|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863914|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863915|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863916|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863917|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863918|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863919|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863920|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863921|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863922|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863923|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
880863|NCT01146418|B3|Baseline|Total|Total of all reporting groups
863934|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863935|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863936|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863937|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863938|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863939|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863940|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863941|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863942|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863943|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863944|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863945|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863949|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863950|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863951|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863952|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863953|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863954|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863955|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863956|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863957|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863958|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863959|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863960|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863961|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863962|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863963|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863964|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863965|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863966|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863967|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863968|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863969|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863970|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863971|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863972|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863973|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863974|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863975|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863976|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863977|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863978|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863979|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863980|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863981|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863982|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863983|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863984|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863985|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863986|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863987|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863988|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863989|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863990|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863991|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863992|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863993|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863994|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863995|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
863996|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
863997|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
863998|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
863999|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864000|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864001|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864002|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864003|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864004|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864005|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864006|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864007|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864008|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864009|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864010|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864011|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864012|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864013|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864014|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864015|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864016|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864017|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864018|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864019|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864020|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864021|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864022|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864023|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864024|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864025|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864026|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864027|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864028|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864029|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864030|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864031|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864032|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864033|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864034|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864035|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864036|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864037|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864038|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864039|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864040|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864041|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864042|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864043|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864044|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864045|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864046|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864047|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864048|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864049|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864050|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864051|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864052|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864053|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864054|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864055|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864056|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864057|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864058|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864059|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864060|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864061|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864062|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864063|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864064|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864065|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864066|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864067|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864068|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864069|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864070|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864071|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864072|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution~Balanced Salt Solution (BSS) Solution"
864073|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864074|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864075|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864076|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS) Solution|"Balanced Salt Solution (BSS) Solution~Balanced Salt Solution (BSS) Solution"
864077|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864078|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864079|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864080|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864081|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864082|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864083|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864084|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864085|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864086|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864087|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864088|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864089|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864090|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864091|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864092|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864093|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864094|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864095|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864096|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864097|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864098|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864099|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864100|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864101|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864102|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864103|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864104|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864105|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864106|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
884133|NCT01135017|B3|Baseline|Total|Total of all reporting groups
864107|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864108|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864109|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864110|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864111|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864112|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864113|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864114|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864115|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864116|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864117|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864118|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864119|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864120|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864121|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864122|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864123|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864124|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864125|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864126|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864127|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864128|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864129|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864130|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864131|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864132|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864133|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864134|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864135|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864136|NCT01193127|O1|Outcome|Solution|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864137|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864138|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864139|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864140|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864141|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864142|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864143|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864144|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864145|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864146|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864147|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864148|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864149|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864150|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864151|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864152|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864153|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864154|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864155|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864156|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864157|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864158|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864159|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864160|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864161|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864162|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864163|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864164|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864166|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864167|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864168|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864169|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864170|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864171|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864172|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864173|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864174|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864175|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864176|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864177|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864178|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864179|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864180|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864181|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864182|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864183|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864184|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864185|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864186|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864187|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864188|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864189|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864190|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864191|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864192|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864193|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864194|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864195|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864196|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864197|NCT01193127|O4|Outcome|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864198|NCT01193127|O3|Outcome|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864199|NCT01193127|O2|Outcome|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864200|NCT01193127|O1|Outcome|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864201|NCT01193127|E4|Reported Event|OMS302 Solution|"OMS302 Solution~OMS302 Solution"
864202|NCT01193127|E3|Reported Event|OMS302 Anti-inflammatory Solution (KE)|"OMS302 Anti-inflammatory Solution~OMS302 Anti-inflammatory Solution"
864203|NCT01193127|E2|Reported Event|OMS302 Mydriatic Solution (PE)|"OMS302 Mydriatic Solution~OMS302 Mydriatic Solution"
864204|NCT01193127|E1|Reported Event|Balanced Salt Solution (BSS)|"Balanced Salt Solution (BSS)~Balanced Salt Solution (BSS)"
864205|NCT01193114|B3|Baseline|Total|Total of all reporting groups
864206|NCT01193114|B2|Baseline|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864207|NCT01193114|B1|Baseline|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864208|NCT01193114|P2|Participant Flow|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864209|NCT01193114|P1|Participant Flow|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864210|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864211|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864212|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864213|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864214|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864215|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864216|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864217|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864218|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864219|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864220|NCT01193114|O2|Outcome|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864221|NCT01193114|O1|Outcome|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864222|NCT01193114|E2|Reported Event|Treatment as Usual|The Mothers were offered services provided through the family shelter.
864223|NCT01193114|E1|Reported Event|Ecologically-Based Behavioral Treatment|Ecologically-Based Treatment was provided over a period of 6 months. The treatment integrated independent housing, case management services and substance abuse counseling. Specifically, the mothers were housed in an apartment of their choice and received three months of utility and rental assistance of up to $600 per month.
864224|NCT01193101|B5|Baseline|Total|Total of all reporting groups
864225|NCT01193101|B4|Baseline|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864226|NCT01193101|B3|Baseline|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864227|NCT01193101|B2|Baseline|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864228|NCT01193101|B1|Baseline|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864229|NCT01193101|P4|Participant Flow|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864230|NCT01193101|P3|Participant Flow|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864231|NCT01193101|P2|Participant Flow|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864232|NCT01193101|P1|Participant Flow|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864233|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864234|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864235|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864236|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864237|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864238|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864239|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864240|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864241|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864242|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864243|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864244|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864245|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864246|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864247|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864248|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864249|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864292|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864250|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864251|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864252|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864253|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864254|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864255|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864256|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864257|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864258|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864259|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864260|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
917332|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
864261|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864262|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864263|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864264|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864265|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864266|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864267|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864268|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864269|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864270|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864271|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864272|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864273|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864274|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864275|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864276|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864277|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864278|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864279|NCT01193101|O4|Outcome|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864280|NCT01193101|O3|Outcome|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864281|NCT01193101|O2|Outcome|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864282|NCT01193101|O1|Outcome|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864283|NCT01193101|E4|Reported Event|Placebo|Placebo daily for 8 weeks during DB treatment, and then single-blind placebo for 1 week.
864284|NCT01193101|E3|Reported Event|LCZ696 400 mg|LCZ696 200 mg LCZ696 plus placebo for one week, then titrated up to 400 mg plus placebo for the remaining 7 weeks during DB treatment, and then single-blind placebo for one week.
864285|NCT01193101|E2|Reported Event|LCZ696 200 mg|LCZ696 200 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864286|NCT01193101|E1|Reported Event|LCZ696 100 mg|LCZ696 100 mg plus placebo daily during double blind (DB) treatment for 8 weeks and then single-blind placebo for one week.
864287|NCT01193049|B1|Baseline|All Participants|All randomized participants
864288|NCT01193049|P2|Participant Flow|Placebo, Then Prednisone|Placebo in the first double blind treatment period and prednisone in the second double blind treatment period
864289|NCT01193049|P1|Participant Flow|Prednisone, Then Placebo|Prednisone in the first double blind treatment period and placebo in the second double blind treatment period
864290|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864293|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864294|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864295|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864296|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864297|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864298|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864299|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864300|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864301|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864302|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864303|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864304|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864305|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864306|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864307|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864308|NCT01193049|O2|Outcome|Placebo|All participants who received at least one dose of placebo
864309|NCT01193049|O1|Outcome|Prednisone|All participants who received at least one dose of prednisone
864317|NCT01193049|E1|Reported Event|Prednisone|All participants who received at least one dose of prednisone
864318|NCT01192542|B1|Baseline|All Subjects|All subjects who enrolled in the study.
864319|NCT01192542|P2|Participant Flow|Enfilcon A Lens/Galyfilcon A Prototype Lens|The enfilcon A contact lens worn daily for 6-8 days first then the galyfilcon A prototype contact lens worn daily for 6-8 days second.
864320|NCT01192542|P1|Participant Flow|Galyfilcon A Prototype Lens/Enfilcon A Lens|The galyfilcon A prototype contact lens worn daily for 6-8 days first then the enfilcon A contact lens worn daily for 6-8 days second.
864321|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
864322|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
864323|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel contact lens.
864324|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel contact lens.
864325|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
864326|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicon hydrogel contact lens.
864327|NCT01192542|O2|Outcome|Enfilcon A Lens|Marketed silicone hydrogel lens.
864328|NCT01192542|O1|Outcome|Galyfilcon A Prototype Lens|Prototype silicone hydrogel lens.
864329|NCT01192542|E1|Reported Event|All Subjects|All subjects who exposed to the Investigation lenses.
864330|NCT01192516|B4|Baseline|Total|Total of all reporting groups
864331|NCT01192516|B3|Baseline|Arm 3|Usual care group
864332|NCT01192516|B2|Baseline|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
864333|NCT01192516|B1|Baseline|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
864334|NCT01192516|P3|Participant Flow|Usual Care Group|Participants receiving usual care
864335|NCT01192516|P2|Participant Flow|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864336|NCT01192516|P1|Participant Flow|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864337|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864338|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864339|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864340|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864341|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864342|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
864343|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864344|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864345|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864346|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864347|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
887234|NCT01126359|E4|Reported Event|Second Intervention (Lidocaine)|
864348|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864349|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864350|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864351|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864352|NCT01192516|O3|Outcome|Arm 3|Usual care group
864353|NCT01192516|O2|Outcome|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
864354|NCT01192516|O1|Outcome|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
864355|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864356|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864357|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864358|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864359|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864360|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864361|NCT01192516|O3|Outcome|Usual Care Group|Participants receiving usual care
864362|NCT01192516|O2|Outcome|General Activity Pacing|General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms
864363|NCT01192516|O1|Outcome|Tailored Activity Pacing|Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant.
864364|NCT01192516|E3|Reported Event|Arm 3|Usual care group
864365|NCT01192516|E2|Reported Event|Arm 2|"General activity pacing and symptom management~General Activity Pacing: Therapeutic intervention using generalized pacing instruction to manage symptoms"
864366|NCT01192516|E1|Reported Event|Arm 1|"Tailored activity pacing~Tailored Activity Pacing: Therapeutic intervention was based on a tailored approach using collected data on symptom and activity patterns of each participant."
864367|NCT01192412|B3|Baseline|Total|Total of all reporting groups
864368|NCT01192412|B2|Baseline|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
864369|NCT01192412|B1|Baseline|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
864370|NCT01192412|P2|Participant Flow|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
864371|NCT01192412|P1|Participant Flow|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
864372|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
864373|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
864374|NCT01192412|O2|Outcome|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
864375|NCT01192412|O1|Outcome|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
864426|NCT01192282|O2|Outcome|HPV DNA Negative|Participants with HPV DNA Negative
864427|NCT01192282|O1|Outcome|HPV DNA Positive|Participants with HPV DNA Positive
864428|NCT01192282|O3|Outcome|HIV Unknown|Number of participants who refused HIV Testing
864429|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
864376|NCT01192412|E2|Reported Event|'Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 85 mmHg.~Intervention is blood pressure management approach.: 'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery."
864377|NCT01192412|E1|Reported Event|'Less Tight' Control.|"The diastolic blood pressure (dBP) treatment goal is 100 mmHg.~Intervention is blood pressure management approach: 1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery."
864378|NCT01192347|B1|Baseline|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864379|NCT01192347|P1|Participant Flow|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864380|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864381|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864382|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864383|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864384|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864385|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864386|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864387|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864857|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
864388|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864389|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864390|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864391|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864392|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864393|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864394|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864395|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864396|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864397|NCT01192347|O1|Outcome|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864398|NCT01192347|E1|Reported Event|Anagrelide Hydrochloride|The decision to initiate Anagrelide Hydrochloride and the dose prescribed was made by treating physician.
864399|NCT01192295|B3|Baseline|Total|Total of all reporting groups
864400|NCT01192295|B2|Baseline|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864401|NCT01192295|B1|Baseline|6 to < 12 Years|Children 6 to < 12 years of age
864402|NCT01192295|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864403|NCT01192295|P1|Participant Flow|6 to < 12 Years|Children 6 to < 12 years of age
864404|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864405|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
864406|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864407|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
864408|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864409|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
864410|NCT01192295|O1|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864411|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
864412|NCT01192295|O2|Outcome|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864413|NCT01192295|O1|Outcome|6 to < 12 Years|Children 6 to < 12 years of age
864414|NCT01192295|E2|Reported Event|≥ 12 to ≤ 16 Years|Children ≥ 12 to ≤ 16 years of age
864415|NCT01192295|E1|Reported Event|6 to < 12 Years|Children 6 to < 12 years of age
864416|NCT01192282|B4|Baseline|Total|Total of all reporting groups
864417|NCT01192282|B3|Baseline|Persistent Cases|The warts presence after completion of treatment
864418|NCT01192282|B2|Baseline|Recurrent Cases|Reappearance of genital warts at 3 or 6 months post-treatment in participants free of warts at completion of treatment
864419|NCT01192282|B1|Baseline|New Cases|Newly diagnosed cases of genital warts
864420|NCT01192282|P1|Participant Flow|Number of Participants|Participants with Genital Warts
864421|NCT01192282|O2|Outcome|HIV Negative|Number of participants with HIV Negative
864422|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
864423|NCT01192282|O3|Outcome|HIV Unknown|Participants who Refused HIV Testing
864424|NCT01192282|O2|Outcome|HIV Negative|Participants with HIV Negative
864425|NCT01192282|O1|Outcome|HIV Positive|Participants with HIV Positive
864430|NCT01192282|O1|Outcome|HIV Positive|Number of participants with HIV Positive
864431|NCT01192282|E3|Reported Event|HIV Unknown|Participants with Genital Warts whom HIV Status was Unknown
864432|NCT01192282|E2|Reported Event|HIV Negative|Participants with Genital Warts who were HIV Negative
864433|NCT01192282|E1|Reported Event|HIV Positive|Participants with Genital Warts who were HIV Positive
864434|NCT01192204|B3|Baseline|Total|Total of all reporting groups
864435|NCT01192204|B2|Baseline|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864436|NCT01192204|B1|Baseline|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864437|NCT01192204|P2|Participant Flow|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864438|NCT01192204|P1|Participant Flow|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864439|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864440|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864441|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864442|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months."
864477|NCT01192178|P2|Participant Flow|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864443|NCT01192204|O2|Outcome|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864444|NCT01192204|O1|Outcome|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months"
864445|NCT01192204|E2|Reported Event|Placebo Gel|"Color/consistency matched placebo (no black raspberry) gel~Color/consistency matched placebo gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
864446|NCT01192204|E1|Reported Event|10% FBR Gel|"Active 10% FBR containing bioadhesive gel~Bioadhesive 10% freeze-dried black raspberry gel: 0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months~No adverse events"
864447|NCT01192191|B3|Baseline|Total|Total of all reporting groups
864448|NCT01192191|B2|Baseline|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864449|NCT01192191|B1|Baseline|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864450|NCT01192191|P2|Participant Flow|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864451|NCT01192191|P1|Participant Flow|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864452|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864453|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864454|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864455|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864456|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864457|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864458|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864459|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864460|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864461|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864462|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864463|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864464|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864505|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864465|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864466|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864467|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864468|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864469|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864470|NCT01192191|O2|Outcome|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864471|NCT01192191|O1|Outcome|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864472|NCT01192191|E2|Reported Event|FF/VI 200/25 µg|Participants received FF/VI Inhalation Powder 200/25 µg, one puff per dose, OD in the morning via the DPI for 52 weeks.
864473|NCT01192191|E1|Reported Event|FF/VI 100/25 µg|Participants received Fluticasone Furoate (FF)/GW642444 (VI) Inhalation Powder 100/25 micrograms (µg), one puff per dose, once daily (OD) in the morning via the dry powder inhaler (DPI) for 52 weeks.
864474|NCT01192178|B3|Baseline|Total|Total of all reporting groups
864475|NCT01192178|B2|Baseline|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864476|NCT01192178|B1|Baseline|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
917333|NCT01037218|O4|Outcome|Placebo|Placebo tablets
864478|NCT01192178|P1|Participant Flow|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
864479|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864480|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864481|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864482|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864483|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864484|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864485|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864486|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864487|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864488|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864489|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864490|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864491|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864492|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864493|NCT01192178|O2|Outcome|FP DISKUS 100 mcg BID|Fluticasone Propionate (FP) DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864494|NCT01192178|O1|Outcome|FSC DISKUS 100/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) at a dose of 100/50 micrograms (mcg) administered as one inhalation twice daily (BID) for 16 weeks
864495|NCT01192178|E2|Reported Event|FP DISKUS 100 mcg BID|FP DISKUS 100 mcg administered as one inhalation BID for 16 weeks
864496|NCT01192178|E1|Reported Event|FSC DISKUS 100/50 mcg BID|FSC at a dose of 100/50 mcg administered as one inhalation BID for 16 weeks
864497|NCT01192152|B1|Baseline|All Enrolled and Treated Participants|
864498|NCT01192152|P2|Participant Flow|Treatment Sequence BA|Treatment B (period 1):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment A (period 2): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2.
864499|NCT01192152|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + 2 Glucophage XR 500 mg under fed conditions; Treatment B (period 2):Fixed dose combination (FDC) tablet (5 mg saxa + 1000 mg metformin XR), single dose, under fed conditions; Treatment C (period 3): FDC tablet (5 mg saxa + 1000 mg metformin XR), once daily for 4 days, under fed conditions. Participants underwent a 2-day washout period between Periods 1 and 2. There was no washout between Periods 2 and 3.
864500|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864501|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864502|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864503|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864504|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
865245|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
864506|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864507|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864508|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864509|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864510|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864511|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864512|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864513|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864514|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864515|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864516|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864517|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864518|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864519|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864520|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864521|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864522|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864523|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864524|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864525|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864526|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864527|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864528|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864529|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864530|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864531|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864532|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864533|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864534|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864535|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864536|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864537|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864538|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864539|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864540|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864541|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864542|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864543|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864544|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864545|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864546|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864547|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864548|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864549|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864550|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864551|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864552|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864553|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864554|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864555|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864556|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864557|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864558|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864559|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864560|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864561|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864562|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864563|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864564|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864565|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864566|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864567|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864568|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864569|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864570|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864571|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864572|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864573|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864574|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864575|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864576|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864577|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864578|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864579|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864580|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864581|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864582|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864583|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864584|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864585|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864586|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864587|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864588|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864589|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864590|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864591|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864592|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864593|NCT01192152|O3|Outcome|Treatment C|Treatment C: FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864594|NCT01192152|O2|Outcome|Treatment B|Treatment B: Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864595|NCT01192152|O1|Outcome|Treatment A|Treatment A: 5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864596|NCT01192152|E3|Reported Event|Saxa 5mg/500mg Metformin, Fed 4 Days|FDC tablet (5 mg saxagliptin + 1000 mg metformin XR), once daily for 4 days, under fed conditions.
864597|NCT01192152|E2|Reported Event|Saxa 5mg/1000mg Metformin, Fed|Fixed dose combination (FDC) tablet (5 mg saxagliptin + 1000 mg metformin XR), single dose, under fed conditions
864598|NCT01192152|E1|Reported Event|Saxa 5mg + 2x500mg Metformin, Fed|5 mg saxagliptin + 2 Glucophage XR 500 mg tablets, single dose under fed conditions
864599|NCT01192139|B1|Baseline|All Enrolled and Treated Participants|
864600|NCT01192139|P6|Participant Flow|Treatment Sequence CBA|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
864601|NCT01192139|P5|Participant Flow|Treatment Sequence CAB|Treatment C (period 1): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
864602|NCT01192139|P4|Participant Flow|Treatment Sequence BCA|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment A (period 3): 5 mg saxagliptin + a single 500 mg metformin XR tablet. Participants underwent at least a 3-day washout period between each treatment.
864603|NCT01192139|P3|Participant Flow|Treatment Sequence BAC|Treatment B (period 1): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment A (period 2): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
864642|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864858|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
864604|NCT01192139|P2|Participant Flow|Treatment Sequence ACB|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment C (period 2): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions; Treatment B (period 3): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions. Participants underwent at least a 3-day washout period between each treatment.
864605|NCT01192139|P1|Participant Flow|Treatment Sequence ABC|Treatment A (period 1): 5 mg saxagliptin + a single 500 mg metformin XR tablet; Treatment B (period 2): fixed-dose combination (FDC) Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions; Treatment C (period 3): FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions. Participants underwent at least a 3-day washout period between each treatment.
864606|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864607|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864608|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864609|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864610|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864611|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864612|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864613|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864614|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864615|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864616|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864617|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864618|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864619|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864620|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864621|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864622|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864623|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864624|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864625|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864626|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864627|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864628|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864629|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864630|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864631|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864632|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864633|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864634|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864635|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864636|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864637|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864638|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864639|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864640|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864641|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864643|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864644|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864645|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864646|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864647|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864648|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864649|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864650|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864651|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864652|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864653|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864654|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864655|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864656|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864657|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864658|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864659|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864660|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864661|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864662|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864663|NCT01192139|O3|Outcome|Treatment C - FDC Tablet (Saxagliptin + Metformin XR), Fasting|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864664|NCT01192139|O2|Outcome|Treatment B - FDC Tablet (Saxagliptin + Metformin XR), Fed|fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864665|NCT01192139|O1|Outcome|Treatment A - Saxagliptin + Metformin XR, Fed|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864666|NCT01192139|E3|Reported Event|Treatment B|Fixed-dose combination (FDC) tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fed conditions
864667|NCT01192139|E2|Reported Event|Treatment C|FDC Tablet (5 mg Saxagliptin + 500 mg Metformin XR) under fasting conditions
864668|NCT01192139|E1|Reported Event|Treatment A|5 mg saxagliptin tablet + a single 500 mg metformin XR tablet under fed conditions
864669|NCT01192126|B1|Baseline|Overall Study|All eligible subjects
864800|NCT01191762|O2|Outcome|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
864670|NCT01192126|P2|Participant Flow|J & J Acuvue Moist, Then B & L Daily Disposable Lens|Johnson & Johnson Acuvue Moist lenses are to be worn for approximately one week. Crossover to Bausch & Lomb new daily disposable lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
864671|NCT01192126|P1|Participant Flow|B & L Daily Disposable Lens, Then J & J Acuvue Moist|Bausch & Lomb new daily disposable lenses are to be worn for approximately one week. Crossover to Johnson & Johnson Acuvue Moist lenses to be worn for approximately one week. Lenses will be worn on a daily wear basis.
864672|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
864673|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
864674|NCT01192126|O2|Outcome|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
864675|NCT01192126|O1|Outcome|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
864676|NCT01192126|E2|Reported Event|Johnson & Johnson Acuvue Moist|"Contact lenses~Johnson & Johnson Acuvue Moist : Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
864677|NCT01192126|E1|Reported Event|Bausch & Lomb New Daily Disposable|"New daily disposable contact lenses~Bausch & Lomb new daily disposable : Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis."
864678|NCT01192022|B5|Baseline|Total|Total of all reporting groups
864679|NCT01192022|B4|Baseline|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864680|NCT01192022|B3|Baseline|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864681|NCT01192022|B2|Baseline|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864682|NCT01192022|B1|Baseline|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864683|NCT01192022|P5|Participant Flow|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864684|NCT01192022|P4|Participant Flow|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864685|NCT01192022|P3|Participant Flow|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864686|NCT01192022|P2|Participant Flow|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864687|NCT01192022|P1|Participant Flow|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864688|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864689|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864690|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864691|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864692|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864693|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864694|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
887235|NCT01126359|E3|Reported Event|Second Intervention (Placebo)|
864695|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864696|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864697|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864698|NCT01192022|O5|Outcome|TachoSil® Extension Analysis Set (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864699|NCT01192022|O4|Outcome|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864700|NCT01192022|O3|Outcome|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864701|NCT01192022|O2|Outcome|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864731|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864702|NCT01192022|O1|Outcome|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864703|NCT01192022|E4|Reported Event|Surgicel® Original (Pediatric Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864704|NCT01192022|E3|Reported Event|TachoSil® (Pediatric Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864705|NCT01192022|E2|Reported Event|Surgicel® Original (Adult Participants)|Surgicel® Original absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864706|NCT01192022|E1|Reported Event|TachoSil® (Adult Participants)|TachoSil® absorbable patches, applied topically, once, intraoperatively to stop bleeding. The number of patches used was determined by the surgeon based on the size of the wound. If bleeding did not stop after 5 minutes treatment was repeated.
864707|NCT01191944|B3|Baseline|Total|Total of all reporting groups
864708|NCT01191944|B2|Baseline|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864709|NCT01191944|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864710|NCT01191944|P2|Participant Flow|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864711|NCT01191944|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864712|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864713|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864714|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864715|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864716|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864717|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864718|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864719|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864720|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864721|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864722|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864723|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864724|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864725|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864726|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864727|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864728|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864729|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864730|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
917334|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
864732|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864733|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864734|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864735|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864736|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864737|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864738|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864739|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864740|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864741|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864742|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864743|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864744|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864745|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864746|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864747|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864748|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864749|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864750|NCT01191944|O2|Outcome|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864751|NCT01191944|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
887236|NCT01126359|E2|Reported Event|First Intervention (Placebo)|
864752|NCT01191944|E2|Reported Event|Pramipexole IR|Pramipexole Immediate Release (IR). Tablets of 0.125 mg, 0.25 mg and 1.0 mg administered 3 times daily to achieve a total daily dose of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg
864753|NCT01191944|E1|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER). Tablets of 0.375 mg and 1.5 mg administered once daily (qd) to achieve daily doses of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg or 4.5 mg
864754|NCT01191827|B3|Baseline|Total|Total of all reporting groups
864755|NCT01191827|B2|Baseline|Clozapine|Patients with schizophrenia treated with clozapine
864756|NCT01191827|B1|Baseline|Risperidone|Patients with schizophrenia treated with risperidone
864757|NCT01191827|P2|Participant Flow|Clozapine|Patients with schizophrenia treated with clozapine
864758|NCT01191827|P1|Participant Flow|Risperidone|Patients with schizophrenia treated with risperidone
864759|NCT01191827|O2|Outcome|Clozapine|Patients with schizophrenia treated with clozapine
864760|NCT01191827|O1|Outcome|Risperidone|Patients with schizophrenia treated with risperidone
864761|NCT01191827|E2|Reported Event|Clozapine|Patients with schizophrenia treated with clozapine
864762|NCT01191827|E1|Reported Event|Risperidone|Patients with schizophrenia treated with risperidone
864763|NCT01191801|B3|Baseline|Total|Total of all reporting groups
864764|NCT01191801|B2|Baseline|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864765|NCT01191801|B1|Baseline|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864766|NCT01191801|P2|Participant Flow|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864767|NCT01191801|P1|Participant Flow|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
866008|NCT01189110|P1|Participant Flow|Arm 1|Intervention- true Stim Flex treatment
864768|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864769|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864770|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864771|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864772|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864773|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864774|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864775|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864776|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864777|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864778|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864779|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864780|NCT01191801|O2|Outcome|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864781|NCT01191801|O1|Outcome|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864782|NCT01191801|E2|Reported Event|Group B (Placebo/Cytarabine)|Placebo (volume matched to vosaroxin) on Days 1 and 4; cytarabine 1 g/m2 daily on Days 1 through 5
864783|NCT01191801|E1|Reported Event|Group A (Vosaroxin/Cytarabine)|Vosaroxin on Days 1 and 4 (90 mg/m2 induction 1; 70 mg/m2 all other cycles); cytarabine 1 g/m2 daily on Days 1 through 5
864784|NCT01191788|B3|Baseline|Total|Total of all reporting groups
864785|NCT01191788|B2|Baseline|Comparison|Treatment as Usual comparison condition
864786|NCT01191788|B1|Baseline|Group CBT|Clients received up to 16 sessions of group CBT for depression
864787|NCT01191788|P2|Participant Flow|Comparison|Treatment as Usual comparison condition
864788|NCT01191788|P1|Participant Flow|Group CBT|Clients received up to 16 sessions of group CBT for depression
864789|NCT01191788|O2|Outcome|Comparison|Usual care.
864790|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
864791|NCT01191788|O2|Outcome|Comparison|Usual care
864792|NCT01191788|O1|Outcome|Group CBT|Usual care + BRIGHT intervention. The BRIGHT intervention included 16 two-hour group sessions of CBT for depression.
864793|NCT01191788|E2|Reported Event|Comparison|Treatment as Usual comparison condition
864794|NCT01191788|E1|Reported Event|Group CBT|Clients received up to 16 sessions of group CBT for depression
864795|NCT01191762|B3|Baseline|Total|Total of all reporting groups
864796|NCT01191762|B2|Baseline|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
864797|NCT01191762|B1|Baseline|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
864798|NCT01191762|P2|Participant Flow|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
864799|NCT01191762|P1|Participant Flow|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
887237|NCT01126359|E1|Reported Event|First Intervention (Lidocaine)|
864801|NCT01191762|O1|Outcome|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
864802|NCT01191762|E2|Reported Event|Placebo Control|"3 placebo tablets with each meal; tablets are identical to sevelamer carbonate 800 mg tablets.~placebo : 3 tablets with each meal"
864803|NCT01191762|E1|Reported Event|Sevelamer Carbonate|"2400 mg (3 pills) with each meal~sevelamer carbonate : 2400 mg with each meal for 4 weeks"
864804|NCT01191749|B1|Baseline|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
864805|NCT01191749|P1|Participant Flow|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
864806|NCT01191749|O1|Outcome|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
864807|NCT01191749|E1|Reported Event|Alemtuzumab|Alemtuzumab 10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
864808|NCT01191736|B8|Baseline|Total|Total of all reporting groups
864809|NCT01191736|B7|Baseline|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
864810|NCT01191736|B6|Baseline|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
864811|NCT01191736|B5|Baseline|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
864812|NCT01191736|B4|Baseline|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
864813|NCT01191736|B3|Baseline|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
864814|NCT01191736|B2|Baseline|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
864815|NCT01191736|B1|Baseline|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
864816|NCT01191736|P7|Participant Flow|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
864817|NCT01191736|P6|Participant Flow|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
864818|NCT01191736|P5|Participant Flow|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
864819|NCT01191736|P4|Participant Flow|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
864820|NCT01191736|P3|Participant Flow|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
864821|NCT01191736|P2|Participant Flow|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
864822|NCT01191736|P1|Participant Flow|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
864823|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
864824|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
864825|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
864826|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
864827|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
864828|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
864829|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
864830|NCT01191736|O7|Outcome|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
864831|NCT01191736|O6|Outcome|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
864832|NCT01191736|O5|Outcome|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
864833|NCT01191736|O4|Outcome|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
864834|NCT01191736|O3|Outcome|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
864835|NCT01191736|O2|Outcome|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
864836|NCT01191736|O1|Outcome|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
864837|NCT01191736|E7|Reported Event|Brief Video + hands-on; Ass'd 2 Months Later|Subjects receive a brief (5-minute) video with hands-on manikin practice, and were assessed 2 months later
864838|NCT01191736|E6|Reported Event|Brief Video; Assessed 2 Months Later|Subjects receive a brief (5-minute) video on hands-only CPR, and were assessed two months later
864839|NCT01191736|E5|Reported Event|Ultra-brief Video; Assessed at 2 Months|Subjects receive an ultra-brief (90-second) video on hands-only CPR, and were assessed 2 months later
864840|NCT01191736|E4|Reported Event|Brief Video + hands-on; Ass'd in 60 Mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
864841|NCT01191736|E3|Reported Event|Brief Video; Assessed in 60 Mins|Subjects receive a brief (5-minute) video on hands-only CPR
864842|NCT01191736|E2|Reported Event|Ultra-brief Video; Assessed in 60 Mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
864843|NCT01191736|E1|Reported Event|No Training, Assessed Within 60 Mins|The subjects received no training and were assessed within 60 minutes
864844|NCT01191723|B1|Baseline|All Subjects|All subjects enrolled in the study.
864845|NCT01191723|P6|Participant Flow|Treatment C, Then B, Then A|Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
864846|NCT01191723|P5|Participant Flow|Treatment C, Then A, Then B|"Treatment C = inhaler placebo and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
864847|NCT01191723|P4|Participant Flow|Treatment B, Then C, Then A|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 4.
864848|NCT01191723|P3|Participant Flow|Treatment B, Then A, Then C|"Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 2. Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 3.~Treatment C = inhaler placebo and placebo capsules at Visit 4."
864849|NCT01191723|P2|Participant Flow|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment C = inhaler placebo and placebo capsules at Visit 3. Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 4."
864850|NCT01191723|P1|Participant Flow|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet at Visit 2.~Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules at Visit 3. Treatment C = inhaler placebo and placebo capsules at Visit 4."
864851|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
864852|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
864853|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
864854|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
864855|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
864856|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
864859|NCT01191723|O3|Outcome|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet.
864860|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
864861|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules at Visit 3.
864862|NCT01191723|O2|Outcome|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules.
864863|NCT01191723|O1|Outcome|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules.
864864|NCT01191723|E3|Reported Event|Treatment A (Moxifloxacin)|Treatment A = inhaler placebo and moxifloxacin 400mg encapsulated tablet
864865|NCT01191723|E2|Reported Event|Treatment B (MAP0004 3.0mg)|Treatment B = MAP0004 3.0mg (via inhalation) and placebo capsules
864866|NCT01191723|E1|Reported Event|Treatment C (Placebo)|Treatment C = inhaler placebo and placebo capsules
864867|NCT01191476|B4|Baseline|Total|Total of all reporting groups
864868|NCT01191476|B3|Baseline|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
864869|NCT01191476|B2|Baseline|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
864870|NCT01191476|B1|Baseline|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
864871|NCT01191476|P3|Participant Flow|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
864872|NCT01191476|P2|Participant Flow|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
864873|NCT01191476|P1|Participant Flow|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
864874|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
864875|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
864876|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
864877|NCT01191476|O3|Outcome|Propofol Induction and Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
864878|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
864879|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
864880|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
864881|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
864882|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
864883|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
864884|NCT01191476|O2|Outcome|Propofol|IV propofol for induction and maintenance of anesthesia
864885|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
864886|NCT01191476|O3|Outcome|Propofol Induction Sevoflurane Maintenance|Propofol bolus for IV induction and sevoflurane for maintenance of anesthesia
864887|NCT01191476|O2|Outcome|Propofol|IV Propofol for induction and maintenance of anesthesia
864888|NCT01191476|O1|Outcome|Sevoflurane|Inhalational sevoflurane for induction and maintenance of anesthesia
864889|NCT01191476|E3|Reported Event|Propofol Induction Sevoflurane Maintenance|Propofol induction and sevoflurane maintenance anesthesia.
864890|NCT01191476|E2|Reported Event|Propofol|Target controlled infusion anesthesia with propofol for induction and maintenance.
864891|NCT01191476|E1|Reported Event|Sevoflurane|Inhalational induction and maintenance anesthesia with sevoflurane.
864892|NCT01191411|B4|Baseline|Total|Total of all reporting groups
864938|NCT01191268|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864893|NCT01191411|B3|Baseline|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
864894|NCT01191411|B2|Baseline|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
864895|NCT01191411|B1|Baseline|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
864896|NCT01191411|P3|Participant Flow|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
864911|NCT01191398|P1|Participant Flow|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
864897|NCT01191411|P2|Participant Flow|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
864898|NCT01191411|P1|Participant Flow|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
864899|NCT01191411|O3|Outcome|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
864900|NCT01191411|O2|Outcome|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
864901|NCT01191411|O1|Outcome|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
864902|NCT01191411|E3|Reported Event|Visit Based Care|"No invitation to complete colorectal cancer screening.~Intervention: Usual medical care. Patients will continue to see their regular physician, and follow their physician's regular standard of care.~Visit Based Care: Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would."
864903|NCT01191411|E2|Reported Event|Mailed Invitations for a Colonoscopy|"Invitation to schedule a colonoscopy are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer with colonoscopy. Mailed invitation to complete one free colonoscopy. Automated and live phone reminders to promote screening completion, plus usual medical care.~Patients with abnormal polyps or adenomas will follow standard clinical protocol after their procedure.~Mailed invitations for a colonoscopy: These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital."
864939|NCT01191268|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864940|NCT01191268|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865246|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
864904|NCT01191411|E1|Reported Event|Mailed Invitations for FIT Test Kits|"Fecal Immunochemical Tests (FIT) kits from Polymedco Incorporated are mailed to patients' homes for free colorectal cancer screening.~Intervention: Screening for colorectal cancer using a Polymedco home FIT kit. Mailed invitation to complete a free one sample home FIT kit. Automated and live phone call reminders to promote screening completion, plus usual medical care.~Patients with abnormal FIT results are navigated to complete a diagnostic colonoscopy.~Mailed invitations for FIT test kits: Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test."
864905|NCT01191398|B4|Baseline|Total|Total of all reporting groups
864906|NCT01191398|B3|Baseline|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864907|NCT01191398|B2|Baseline|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864908|NCT01191398|B1|Baseline|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
864909|NCT01191398|P3|Participant Flow|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864910|NCT01191398|P2|Participant Flow|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
865172|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
864912|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864913|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864914|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
864915|NCT01191398|O3|Outcome|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864916|NCT01191398|O2|Outcome|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864917|NCT01191398|O1|Outcome|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
864918|NCT01191398|E3|Reported Event|Glycopyrrolate|Glycopyrrolate (0.01mg/kg): Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864919|NCT01191398|E2|Reported Event|Atropine|Atropine (0.01mg/kg): Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
864920|NCT01191398|E1|Reported Event|Placebo|"Normal Saline0.9% will act as a placebo.~Placebo: Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine"
864921|NCT01191320|B4|Baseline|Total|Total of all reporting groups
864922|NCT01191320|B3|Baseline|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864923|NCT01191320|B2|Baseline|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864924|NCT01191320|B1|Baseline|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
864925|NCT01191320|P3|Participant Flow|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864926|NCT01191320|P2|Participant Flow|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864927|NCT01191320|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
864928|NCT01191320|O3|Outcome|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864929|NCT01191320|O2|Outcome|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864930|NCT01191320|O1|Outcome|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
864931|NCT01191320|E3|Reported Event|Androxal 25 mg|"25 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864932|NCT01191320|E2|Reported Event|Androxal 12.5 mg|"12.5 mg/day~Androxal: Capsules 12.5 mg or 25 mg 1x daily for 3 months"
864933|NCT01191320|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo capsule 1x daily for 3 months"
864934|NCT01191268|B4|Baseline|Total|Total of all reporting groups
864935|NCT01191268|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864936|NCT01191268|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864937|NCT01191268|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865247|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
864941|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864942|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864943|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864944|NCT01191268|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg , subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864945|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864946|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864947|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864948|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865359|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
864949|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864950|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864951|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864952|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864953|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864954|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864955|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864956|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864957|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864958|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864959|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864960|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864961|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864962|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864963|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864964|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864965|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864966|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865159|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
864967|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864968|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864969|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864970|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864971|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864972|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864973|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864974|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864975|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864976|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864977|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864978|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864979|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864980|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864981|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864982|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864983|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864984|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864985|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864986|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864987|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864988|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864989|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864990|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864991|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864992|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865019|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864993|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864994|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864995|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864996|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864997|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864998|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
864999|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865054|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865000|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865001|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865002|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865003|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865004|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865005|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865006|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865007|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865008|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865009|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865010|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865011|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865012|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865013|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865014|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865015|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865016|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865017|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865018|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865119|NCT01190878|O2|Outcome|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
865120|NCT01190878|O1|Outcome|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
865020|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865021|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865022|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865023|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865024|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865025|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865026|NCT01191268|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865027|NCT01191268|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865028|NCT01191268|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865029|NCT01191268|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865030|NCT01191268|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865031|NCT01191268|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Insulin Lispro: dose titration based on blood glucose measures, subcutaneous (SC), thrice daily (after each meal) for 52 weeks"
865032|NCT01191255|B5|Baseline|Total|Total of all reporting groups
865033|NCT01191255|B4|Baseline|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865034|NCT01191255|B3|Baseline|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865035|NCT01191255|B2|Baseline|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
865036|NCT01191255|B1|Baseline|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
865037|NCT01191255|P4|Participant Flow|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865038|NCT01191255|P3|Participant Flow|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865039|NCT01191255|P2|Participant Flow|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
865040|NCT01191255|P1|Participant Flow|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
865041|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865042|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865043|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
865044|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
865045|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865046|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865121|NCT01190878|E4|Reported Event|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
865122|NCT01190878|E3|Reported Event|Xibrom BID|Xibrom™: Xibrom dosed BID
887275|NCT01126060|B3|Baseline|Total|Total of all reporting groups
865047|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
865048|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
865049|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865050|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865051|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
865052|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
865053|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865097|NCT01190891|B3|Baseline|Total|Total of all reporting groups
865055|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
865056|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
865057|NCT01191255|O4|Outcome|KRX-0502 (Ferric Citrate)-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865058|NCT01191255|O3|Outcome|Placebo-EAP|Patients that completed the 52-week Safety Assessment Period on KRX-0502 were randomized 1:1 to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period.
865059|NCT01191255|O2|Outcome|KRX-0502 (Ferric Citrate)-SAP|"Patients received KRX-0502 (ferric citrate) during a 52-week Safety Assessment Period.~Patients that completed the 52-week Safety Assessment Period were randomized to continue to receive KRX-0502 (ferric citrate) or placebo for a 4-week Efficacy Assessment Period."
865060|NCT01191255|O1|Outcome|Active Control-SAP|Patients received either PhosLo (calcium acetate), Renvela (sevelamer carbonate), or a combination of these treatments during a 52-week Safety Assessment Period.
865061|NCT01191255|E4|Reported Event|Placebo (EAP)|Efficacy Assessment Period (Week 52-56)
865062|NCT01191255|E3|Reported Event|KRX-0502 (EAP)|Efficacy Assessment Period (Week 52-56)
865063|NCT01191255|E2|Reported Event|Active Control (SAP)|Safety Assessment Period (Week 1-52)
865064|NCT01191255|E1|Reported Event|KRX-0502 (SAP)|Safety Assessment Period (Week 1-52)
865065|NCT01191242|B1|Baseline|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865066|NCT01191242|P1|Participant Flow|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865067|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865068|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865069|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865070|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865071|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865072|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865073|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865074|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865075|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865076|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865077|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865078|NCT01191242|O1|Outcome|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865079|NCT01191242|E1|Reported Event|Methadone Maintenance Observation Group|A consecutive sample of individuals initiating methadone maintenance treatment for opioid addiction.
865123|NCT01190878|E2|Reported Event|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
865124|NCT01190878|E1|Reported Event|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
865160|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865242|NCT01190566|P1|Participant Flow|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
865080|NCT01191190|B1|Baseline|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865081|NCT01191190|P1|Participant Flow|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865082|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865170|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865083|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865084|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865085|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865086|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865087|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865088|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865089|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865090|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865158|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865243|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
865091|NCT01191190|O1|Outcome|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865092|NCT01191190|E1|Reported Event|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered.~Each patient may receive 3 cycles of treatment in the absence of progressive disease or significant toxicity.~Ofatumumab/HDMP: High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
865093|NCT01191086|B1|Baseline|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
865094|NCT01191086|P1|Participant Flow|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
865095|NCT01191086|O1|Outcome|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
865096|NCT01191086|E1|Reported Event|Open-label USL255|"Topiramate extended-release capsules (USL255) up to a maximum of 400 mg per day~USL255"
865098|NCT01190891|B2|Baseline|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
865099|NCT01190891|B1|Baseline|Manual Physical Therapy|Manual Physical Therapy: Same as arm description
865100|NCT01190891|P2|Participant Flow|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
865101|NCT01190891|P1|Participant Flow|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
865102|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
865103|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
865104|NCT01190891|O2|Outcome|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
865105|NCT01190891|O1|Outcome|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
865106|NCT01190891|E2|Reported Event|Corticosteroid Injection (Subacromial)|"Location: Subacromial space; Syringe: 10mL; Needle: 25 gauge, 1.5 inch; Anesthetic: 6 mL of 1% lidocaine or marcaine; Corticosteroid: 1.0 mL Triamcinolone Acetonide (Kenalog), 40 mg/mL~Corticosteroid Injection: Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg)."
865107|NCT01190891|E1|Reported Event|Manual Physical Therapy|"The orthopaedic manual physical therapy (OMPT) intervention approach used in this study was based on an impairment model. The physical therapist providing the intervention addressed impairments found in the shoulder joints to include the acromioclavicular joint, glenohumeral joint, and scapular-thoracic joints, and cervical/thoracic spine. Patients received procedures tailored to their specific impairments. Procedures included mobilizations and manipulations of the joint and soft-tissues.~Manual Physical Therapy: Same as arm description"
865108|NCT01190878|B5|Baseline|Total|Total of all reporting groups
865109|NCT01190878|B4|Baseline|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
865110|NCT01190878|B3|Baseline|Xibrom BID|Xibrom™: Xibrom dosed BID
865111|NCT01190878|B2|Baseline|ISV-303 QD|ISV-303: 0.075% of Bromfenac in DuraSite Dosed QD
865112|NCT01190878|B1|Baseline|ISV-303 BID|ISV-303: 0.075% of Bromfenac in DuraSite Dosed BID
865113|NCT01190878|P4|Participant Flow|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle dosed BID
865114|NCT01190878|P3|Participant Flow|Xibrom BID|Xibrom™: 0.09% bromfenac dosed BID
865115|NCT01190878|P2|Participant Flow|ISV-303 QD|ISV-303: 0.075% bromfenac in DuraSite dosed QD
865116|NCT01190878|P1|Participant Flow|ISV-303 BID|ISV-303: 0.075% bromfenac in DuraSite dosed BID
865117|NCT01190878|O4|Outcome|DuraSite Vehicle BID|DuraSite Vehicle: Vehicle Dosed BID
865118|NCT01190878|O3|Outcome|Xibrom BID|Xibrom™: Xibrom dosed BID
865125|NCT01190865|B1|Baseline|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
865126|NCT01190865|P1|Participant Flow|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
865127|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
865128|NCT01190865|O1|Outcome|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
865171|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
917335|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
865129|NCT01190865|E1|Reported Event|HP802-247|"Assessment Duration = 8 days Assessment Duration = 15 days Assessment Duration = 22 days Assessment Duration = 29 days Assessment Duration = 31 days Assessment Duration = 43 days Assessment Duration = 50 days Assessment Duration = 57 days~HP802-247: One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin."
865130|NCT01190839|B3|Baseline|Total|Total of all reporting groups
865131|NCT01190839|B2|Baseline|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
865132|NCT01190839|B1|Baseline|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
865133|NCT01190839|P2|Participant Flow|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
865134|NCT01190839|P1|Participant Flow|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
865135|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
865136|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
865137|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
865138|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
865139|NCT01190839|O2|Outcome|Infliximab 5 mg/kg|Participants randomized to receive Infliximab 5 milligram per kilogram (mg/kg) at Week 0 and then every 8 weeks thereafter through Week 200.
865140|NCT01190839|O1|Outcome|Placebo|Participants randomized to receive placebo at Week 0 and then every 8 weeks thereafter through Week 200.
865141|NCT01190839|E4|Reported Event|First Infliximab 5 mg/kg Then Infliximab 10 mg/kg|Participants had a protocol defined dose increase from infliximab 5 mg/kg to infliximab 10 mg/kg. Only safety results after the dose increase were included in this group.
865142|NCT01190839|E3|Reported Event|First Placebo Then Infliximab 5 mg/kg|Participants had a protocol defined dose increase from Placebo to infliximab 5 mg/kg. Only safety results after start of infliximab were included in this group.
865143|NCT01190839|E2|Reported Event|Infliximab 5 mg/kg|Participants treated with Infliximab 5 mg/kg at any time through the final visit or through a protocol defined dose increase. If a participants had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
865144|NCT01190839|E1|Reported Event|Placebo|Participants treated with placebo through the final visit or through a protocol defined dose increase. If a participant had a protocol defined dose increase, only safety results prior to the dose increase will be included in this group.
865145|NCT01190813|B3|Baseline|Total|Total of all reporting groups
865146|NCT01190813|B2|Baseline|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865147|NCT01190813|B1|Baseline|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865148|NCT01190813|P2|Participant Flow|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865149|NCT01190813|P1|Participant Flow|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865150|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865151|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865152|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865153|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865154|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865155|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865156|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865157|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865161|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865162|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865163|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865164|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865165|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865166|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865167|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865168|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865169|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865173|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865174|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865175|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865176|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865177|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865178|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865179|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865180|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865181|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865182|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865183|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865184|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865185|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865186|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865187|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865188|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865189|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865190|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865191|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865192|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865193|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865194|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865195|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865196|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865197|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865198|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865199|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865200|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865244|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865201|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865202|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865203|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865204|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865205|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865206|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865207|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865208|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865209|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865210|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865211|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865212|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865213|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865214|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865215|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865216|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865217|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865218|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865219|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865220|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865221|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865222|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865223|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865224|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865225|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865226|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865227|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865228|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865229|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865230|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865231|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865232|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865233|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865234|NCT01190813|O2|Outcome|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865235|NCT01190813|O1|Outcome|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865236|NCT01190813|E2|Reported Event|Placebo|"Oral placebo tid~Placebo: Oral placebo tid~Patching: Two hours of daily patching"
865237|NCT01190813|E1|Reported Event|Levodopa/Carbidopa|"Levodopa 0.76 mg/kg with Carbidopa 0.17 mg/kg tid~Levodopa/Carbidopa: Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid~Patching: Two hours of daily patching"
865238|NCT01190566|B3|Baseline|Total|Total of all reporting groups
865239|NCT01190566|B2|Baseline|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
865240|NCT01190566|B1|Baseline|Pathologic Complete Responders (pCR)|The absence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
865241|NCT01190566|P2|Participant Flow|Non-pCR|The presence of invasive tumor cells (ductal carcinoma in situ may have been present) after surgery.
865248|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865249|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
865250|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865251|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
865252|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865253|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
865254|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865255|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
865256|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865257|NCT01190566|O2|Outcome|Non-pCR|the presence of invasive tumor cells after surgery
865258|NCT01190566|O1|Outcome|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865259|NCT01190566|O1|Outcome|Pathologic Response to Chemotherapy|Degree of pathologic response to the neoadjuvant chemotherapy
865260|NCT01190566|E2|Reported Event|Non-pCR|the presence of invasive tumor cells after surgery
865261|NCT01190566|E1|Reported Event|Pathologic Complete Responders (pCR)|the absence of invasive tumor cells after surgery
865262|NCT01190527|B1|Baseline|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
865360|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
917336|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
865263|NCT01190527|P1|Participant Flow|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
865264|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
865265|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
865266|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
865267|NCT01190527|O1|Outcome|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
865268|NCT01190527|E1|Reported Event|Adaptive Radiation|Conformal radiotherapy (RT) was given in 30 daily fractions. RT dose was individualized to a fixed risk of lung toxicity and adaptively escalated to the residual tumor on mid-tx FDG-PET up to a total physical dose of 86 Gy.
865269|NCT01190514|B1|Baseline|Entire Study Population|Participants randomized to 1 of the 4 treatment sequences beginning with DVS SR 25 mg*2 Fed (A); or DVS SR 50 mg Fed (B); or DVS SR 25 mg*2 Fasted (C); or DVS SR 50 mg Fasted (D).
865270|NCT01190514|P4|Participant Flow|DVS SR 50 mg Fasted (D) First|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865271|NCT01190514|P3|Participant Flow|DVS SR 25 mg*2 Fasted (C) First|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
865272|NCT01190514|P2|Participant Flow|DVS SR 50 mg Fed (B) First|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865273|NCT01190514|P1|Participant Flow|DVS SR 25 mg*2 Fed (A) First|Desvenlafaxine sustained release (DVS SR) formulation (PF-0212375) 25 milligrams (mg) as 2 tablets (25 mg*2) on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
865274|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865275|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
865276|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865277|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
865278|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865279|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
865280|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865281|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
865282|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865283|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
865284|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865285|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
865286|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865287|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
865288|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865289|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
865290|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865291|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
865292|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865293|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
865294|NCT01190514|O4|Outcome|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865295|NCT01190514|O3|Outcome|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state.
865296|NCT01190514|O2|Outcome|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865297|NCT01190514|O1|Outcome|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state.
865298|NCT01190514|E4|Reported Event|DVS SR 50 mg Fasted|DVS SR 50 mg tablet on Day 1 of study period in fasted state.
865299|NCT01190514|E3|Reported Event|DVS SR 25 mg*2 Fasted|DVS SR 25 mg*2 tablets on Day 1 of study period in fasted state (fasted 8 hours prior to dosing).
865300|NCT01190514|E2|Reported Event|DVS SR 50 mg Fed|DVS SR 50 mg tablet on Day 1 of study period in fed state.
865301|NCT01190514|E1|Reported Event|DVS SR 25 mg*2 Fed|DVS SR 25 mg*2 tablets on Day 1 of study period in fed state (finished a high-fat breakfast 20 minutes prior to dosing).
865302|NCT01190436|B1|Baseline|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865303|NCT01190436|P1|Participant Flow|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865304|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
865305|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865306|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865307|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865308|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865309|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865310|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865311|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865312|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865313|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865314|NCT01190436|O1|Outcome|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than or equal to 130/80 millimeter of mercury (mmHg) after 2 weeks, then the dose was adjusted to 10 mg once daily. Total duration of study treatment was 12 weeks.
865315|NCT01190436|E1|Reported Event|Bisoprolol|Bisoprolol was administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure was greater than 130/80 millimeter of mercury (mmHg) or equal to 130/80 mmHg after week, bisoprolol dose adjusted to 10 mg once daily. Duration of the treatment was 12 weeks.
865316|NCT01190306|B3|Baseline|Total|Total of all reporting groups
865317|NCT01190306|B2|Baseline|Sham Control|Eyes in the control group will be treated with riboflavin only.
865318|NCT01190306|B1|Baseline|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
865319|NCT01190306|P2|Participant Flow|Sham Control|Eyes in the control group will be treated with riboflavin only.
865320|NCT01190306|P1|Participant Flow|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
865321|NCT01190306|O2|Outcome|Sham Control|Eyes in the control group will be treated with riboflavin only.
865322|NCT01190306|O1|Outcome|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
865323|NCT01190306|E2|Reported Event|Sham Control|Eyes in the control group will be treated with riboflavin only.
865324|NCT01190306|E1|Reported Event|CXL Treatment|Eyes randomized to the CXL treatment group with be treated with riboflavin and UV light.
865325|NCT01190267|B3|Baseline|Total|Total of all reporting groups
865326|NCT01190267|B2|Baseline|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
865327|NCT01190267|B1|Baseline|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
865328|NCT01190267|P2|Participant Flow|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
865329|NCT01190267|P1|Participant Flow|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg twice daily (BID) on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
865330|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
865331|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
865332|NCT01190267|O2|Outcome|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
865333|NCT01190267|O1|Outcome|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
865334|NCT01190267|E2|Reported Event|Asenapine - Participants Who Were 18 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were 18 years old at entry into the extension study.
865335|NCT01190267|E1|Reported Event|Asenapine - Participants Who Were ≤17 Years Old|In this extension study all participants received open-label asenapine 2.5 mg BID on Day 1-3, which was increased to 5.0 mg BID on Day 4 (dose could be increased earlier). Asenapine dosing was flexible for the remainder of the 26-week open-label drug administration period, and could be adjusted to either 2.5 mg or 5.0 mg BID. Participants in this reporting group were ≤17 years old at entry into the extension study.
865336|NCT01190254|B4|Baseline|Total|Total of all reporting groups
865337|NCT01190254|B3|Baseline|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865338|NCT01190254|B2|Baseline|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865339|NCT01190254|B1|Baseline|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865340|NCT01190254|P3|Participant Flow|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865341|NCT01190254|P2|Participant Flow|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865342|NCT01190254|P1|Participant Flow|Placebo|Participants receive placebo asenapine tablets sublingually twice daily (BID) for 8 weeks
865343|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865344|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865345|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865346|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865347|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865348|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865349|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
890146|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
865350|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865351|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865352|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865353|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865354|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865355|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865356|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865357|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865358|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
866313|NCT01188538|O2|Outcome|BPO Gel|BPO Gel Topical to the face, once daily application in the evening
865361|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865362|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865363|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865364|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865365|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865366|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865367|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865368|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865369|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865370|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865371|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865372|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865373|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865374|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865375|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865376|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865377|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865378|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865379|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865380|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865381|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865382|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865383|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865384|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865385|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865386|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865387|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865388|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865389|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865390|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865391|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865392|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865393|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865394|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865395|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865396|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865397|NCT01190254|O3|Outcome|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865398|NCT01190254|O2|Outcome|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865399|NCT01190254|O1|Outcome|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865400|NCT01190254|E3|Reported Event|Asenapine 5.0 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID through Day 3. On Day 4 participants receive asenapine 2.5 mg in the morning and 5.0 mg in the evening. Participants receive active asenapine 5.0 mg tablets sublingually BID for the remainder of the 8-week treatment period
865401|NCT01190254|E2|Reported Event|Asenapine 2.5 mg BID|Participants receive active asenapine 2.5 mg tablets sublingually BID for 8 weeks
865402|NCT01190254|E1|Reported Event|Placebo|Participants receive placebo asenapine tablets sublingually BID for 8 weeks
865403|NCT01190215|B3|Baseline|Total|Total of all reporting groups
865404|NCT01190215|B2|Baseline|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865405|NCT01190215|B1|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865406|NCT01190215|P2|Participant Flow|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865407|NCT01190215|P1|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865408|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865409|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865410|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865411|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865412|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865413|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865414|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865415|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865503|NCT01190124|B2|Baseline|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865416|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865417|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865418|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865419|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865420|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865421|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865512|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
917337|NCT01037218|O4|Outcome|Placebo|Placebo tablets
865422|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865423|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865424|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865425|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865426|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865427|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865428|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865429|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865430|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865431|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865432|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865433|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865434|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865435|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865436|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865437|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865438|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865439|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865706|NCT01189604|B4|Baseline|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865440|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865441|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865442|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865443|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865444|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865445|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865446|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865447|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865448|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865449|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865450|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865451|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865452|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865453|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865454|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865455|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865456|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865457|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865458|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865459|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865460|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865461|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865462|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865463|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865707|NCT01189604|B3|Baseline|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865464|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865465|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865466|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865467|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865468|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865469|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865470|NCT01190215|O2|Outcome|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865471|NCT01190215|O1|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865472|NCT01190215|E2|Reported Event|Havrix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 first dose of Havrix vaccine (subjects aged above 15 years) or Havrix-Junior vaccine (subjects aged 15 years and below). A second dose was given outside the study setting, at Month 6. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865473|NCT01190215|E1|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix vaccine received 1 dose of Fluarix vaccine. All vaccines were administered in the deltoid region of the non-dominant arm on Day 0.
865474|NCT01190150|B3|Baseline|Total|Total of all reporting groups
865475|NCT01190150|B2|Baseline|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
865476|NCT01190150|B1|Baseline|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
865477|NCT01190150|P2|Participant Flow|1.3 g / 0.65 g Tranexamic Acid|Participants received a single dose of 1.3 g tranexamic acid on Day 1 and a single dose of 0.65 g tranexamic acid on Day 8.
865478|NCT01190150|P1|Participant Flow|0.65 g / 1.3 g Tranexamic Acid|Participants received a single dose of 0.65 g tranexamic acid on Day 1 and a single dose of 1.3 g tranexamic acid on Day 8.
865479|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865480|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865481|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865482|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865483|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865484|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865485|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865486|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865487|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865488|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865489|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865490|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865491|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865492|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865493|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865494|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865495|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865496|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865497|NCT01190150|O2|Outcome|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865498|NCT01190150|O1|Outcome|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865499|NCT01190150|E2|Reported Event|1.3 g Tranexamic Acid|Participants were treated with a single dose of 1.3 g tranexamic acid.
865500|NCT01190150|E1|Reported Event|0.65 g Tranexamic Acid|Participants were treated with a single dose of 0.65 g tranexamic acid.
865501|NCT01190124|B4|Baseline|Total|Total of all reporting groups
865502|NCT01190124|B3|Baseline|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
865751|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865504|NCT01190124|B1|Baseline|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865505|NCT01190124|P3|Participant Flow|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
865506|NCT01190124|P2|Participant Flow|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865507|NCT01190124|P1|Participant Flow|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865508|NCT01190124|O1|Outcome|Total|Total number of patients studied
865509|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
865510|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865511|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865513|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865514|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865515|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
865516|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
865517|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
865518|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
865519|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
865520|NCT01190124|O1|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure
865521|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
865522|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
865523|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
865524|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
865525|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
865526|NCT01190124|O1|Outcome|HIV Patients With Therapy Replacement|HIV infected patients in whom T20 was replaced by raltegravir
865527|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
865528|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865529|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865530|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
865531|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865532|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865533|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
865534|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865535|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865536|NCT01190124|O3|Outcome|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
865537|NCT01190124|O2|Outcome|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865538|NCT01190124|O1|Outcome|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865539|NCT01190124|E3|Reported Event|HIV-2 With Therapeutic Failure|Adult HIV-2 infected patients with therapeutic failure (including those at virologic suppression but with decreasing immunological response with prior treatment)
892091|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
865540|NCT01190124|E2|Reported Event|HIV With Need for Therapy Change|Adult HIV infected patients at virologic suppression (with RNA HIV <40 cop/mL), who needed to change antiretroviral therapy due to inacceptable toxicity, as determined by the investigator (including patients who needed to replace T20)
865541|NCT01190124|E1|Reported Event|HIV-1 at Virologic Failure|Adult multiple-experienced HIV-1 infected patients at virologic failure (patients under treatment with RNA HIV >1000 cop/mL)
865542|NCT01190098|B3|Baseline|Total|Total of all reporting groups
865543|NCT01190098|B2|Baseline|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865544|NCT01190098|B1|Baseline|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865545|NCT01190098|P2|Participant Flow|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865546|NCT01190098|P1|Participant Flow|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865547|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865548|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865549|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865550|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865551|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865552|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865553|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865554|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865555|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865556|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865557|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865558|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865559|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865560|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865561|NCT01190098|O2|Outcome|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865562|NCT01190098|O1|Outcome|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865563|NCT01190098|E2|Reported Event|Sugar Pill|Placebo: Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
865564|NCT01190098|E1|Reported Event|Lacosamide|"Lacosamide: Subjects randomized to lacosamide according to the following schedule:~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
865565|NCT01190085|B4|Baseline|Total|Total of all reporting groups
865566|NCT01190085|B3|Baseline|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865567|NCT01190085|B2|Baseline|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865568|NCT01190085|B1|Baseline|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865569|NCT01190085|P3|Participant Flow|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865570|NCT01190085|P2|Participant Flow|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865571|NCT01190085|P1|Participant Flow|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865572|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865573|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865574|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865575|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865576|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865577|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865578|NCT01190085|O3|Outcome|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865579|NCT01190085|O2|Outcome|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865580|NCT01190085|O1|Outcome|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865581|NCT01190085|E3|Reported Event|Saline Solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865582|NCT01190085|E2|Reported Event|Ghrelin (3 Microg/kg)|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865583|NCT01190085|E1|Reported Event|Ghrelin (1 Microg/kg)|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
865717|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865584|NCT01190007|B1|Baseline|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865585|NCT01190007|P1|Participant Flow|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865586|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865587|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865588|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865589|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865590|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865591|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865592|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865628|NCT01189812|O1|Outcome|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865593|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865594|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865595|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865596|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865597|NCT01190007|O1|Outcome|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865598|NCT01190007|E1|Reported Event|Caduet|Single pill combination of amlodipine and atorvastatin (Caduet) of the specified strength (2.5 mg/5 mg, 2.5 mg/10 mg, 5 mg/5 mg, or 5 mg/10 mg, as Amlodipine/Atorvastatin) was administered once daily for 52 weeks. Caduet doses were determined according to the doses of amlodipine and atorvastatin which were administered prior to the study assignment in line with the levels of blood pressure and low-density lipoprotein cholesterol (LDL-C) at Week 0. The fixed dose was administered up to Week 12, then, the dose was adjusted based on the blood pressure and LDL-C observed after.
865599|NCT01189890|B3|Baseline|Total|Total of all reporting groups
865600|NCT01189890|B2|Baseline|Glimepiride|Glimepiride 1-6 mg QD
865601|NCT01189890|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865602|NCT01189890|P2|Participant Flow|Glimepiride|Glimepiride 1-6 mg QD
865603|NCT01189890|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865604|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865605|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865606|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865607|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865608|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865609|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865610|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865611|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865612|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865613|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865614|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865615|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865616|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865617|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865618|NCT01189890|O2|Outcome|Glimepiride|Glimepiride 1-6 mg QD
865619|NCT01189890|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865620|NCT01189890|E2|Reported Event|Glimepiride|Glimepiride 1-6 mg QD
865621|NCT01189890|E1|Reported Event|Sitagliptin|Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
865622|NCT01189812|B3|Baseline|Total|Total of all reporting groups
865623|NCT01189812|B2|Baseline|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865624|NCT01189812|B1|Baseline|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865625|NCT01189812|P2|Participant Flow|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865626|NCT01189812|P1|Participant Flow|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865627|NCT01189812|O2|Outcome|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865659|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865629|NCT01189812|E2|Reported Event|Lithium|Patients were administered a 20 mg citalopram tablet in combination with a 300 mg lithium capsule. Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865630|NCT01189812|E1|Reported Event|Placebo (Sugar Pill)|Patients were administered a 20 mg citalopram tablet in combination with a placebo capsule (sugar pill). Patients were instructed to take medication once daily, by mouth, preferably in the morning.
865631|NCT01189760|B4|Baseline|Total|Total of all reporting groups
865632|NCT01189760|B3|Baseline|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865633|NCT01189760|B2|Baseline|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865634|NCT01189760|B1|Baseline|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865635|NCT01189760|P3|Participant Flow|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865718|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
917338|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
865636|NCT01189760|P2|Participant Flow|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865637|NCT01189760|P1|Participant Flow|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865638|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865639|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865640|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865641|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865642|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865643|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865644|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865645|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865646|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865647|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865648|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865649|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865650|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865651|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865652|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865653|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865654|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865655|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865656|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865657|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865658|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
892092|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
865660|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865661|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865662|NCT01189760|O3|Outcome|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865663|NCT01189760|O2|Outcome|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865664|NCT01189760|O1|Outcome|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865665|NCT01189760|E3|Reported Event|Placebo (Normal Saline)|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865666|NCT01189760|E2|Reported Event|onabotulinumtoxinA 24U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose and placebo (normal saline) injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865667|NCT01189760|E1|Reported Event|onabotulinumtoxinA 44U|44 units (U) onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients received two treatments 4 months apart.
865668|NCT01189747|B3|Baseline|Total|Total of all reporting groups
865669|NCT01189747|B2|Baseline|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865670|NCT01189747|B1|Baseline|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865671|NCT01189747|P2|Participant Flow|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865672|NCT01189747|P1|Participant Flow|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865673|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865674|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865675|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865676|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865677|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865678|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865679|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865680|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865681|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865682|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865683|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865684|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865685|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865686|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865687|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865688|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865689|NCT01189747|O2|Outcome|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865690|NCT01189747|O1|Outcome|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865691|NCT01189747|E2|Reported Event|Placebo (Normal Saline)|normal saline injected into bilateral Crow's Feet Line areas on Day 1.
865692|NCT01189747|E1|Reported Event|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1.
865693|NCT01189617|B3|Baseline|Total|Total of all reporting groups
865694|NCT01189617|B2|Baseline|Female|Female Participants
865695|NCT01189617|B1|Baseline|Male|Male Participants
865696|NCT01189617|P2|Participant Flow|Female|Female Participants
865697|NCT01189617|P1|Participant Flow|Male|Male Participants
865698|NCT01189617|O2|Outcome|Female|Female Participants
865699|NCT01189617|O1|Outcome|Male|Male Participants
865700|NCT01189617|E2|Reported Event|Female|Female Participants
865701|NCT01189617|E1|Reported Event|Male|Male Participants
865702|NCT01189604|B8|Baseline|Total|Total of all reporting groups
865703|NCT01189604|B7|Baseline|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865704|NCT01189604|B6|Baseline|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
865705|NCT01189604|B5|Baseline|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865708|NCT01189604|B2|Baseline|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865709|NCT01189604|B1|Baseline|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865710|NCT01189604|P7|Participant Flow|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865711|NCT01189604|P6|Participant Flow|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
865712|NCT01189604|P5|Participant Flow|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865713|NCT01189604|P4|Participant Flow|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865714|NCT01189604|P3|Participant Flow|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865715|NCT01189604|P2|Participant Flow|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865716|NCT01189604|P1|Participant Flow|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865719|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865720|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865721|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865722|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865723|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865724|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865725|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
865726|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865727|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865728|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865729|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865730|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865731|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865732|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
865733|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865734|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865735|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865736|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865737|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865738|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865739|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
865740|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865741|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865742|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865743|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865744|NCT01189604|O1|Outcome|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865745|NCT01189604|O7|Outcome|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865746|NCT01189604|O6|Outcome|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
865747|NCT01189604|O5|Outcome|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865748|NCT01189604|O4|Outcome|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865749|NCT01189604|O3|Outcome|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865750|NCT01189604|O2|Outcome|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865752|NCT01189604|E7|Reported Event|Arm 7 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
865753|NCT01189604|E6|Reported Event|Arm 6 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
865754|NCT01189604|E5|Reported Event|Arm 5 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
865755|NCT01189604|E4|Reported Event|Arm 4 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
865756|NCT01189604|E3|Reported Event|Arm 3 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
865757|NCT01189604|E2|Reported Event|Arm 2 - ICI35,868 (Propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
865758|NCT01189604|E1|Reported Event|Arm 1 - Placebo|Infusion of placebo, same infusion rates as for arm 2
865759|NCT01189500|B1|Baseline|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1. DVS SR 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865794|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865832|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
865760|NCT01189500|P1|Participant Flow|Tamoxifen 40 mg, Tamoxifen 40 mg + DVS SR 100 mg|Tamoxifen (TAMOX) 40 milligrams (mg) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) 100 mg as a single oral dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865761|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865762|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865763|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865764|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865765|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865766|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865767|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865768|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865769|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865770|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865771|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865772|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865773|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865774|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865775|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865776|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865777|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865778|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865779|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865780|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865781|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865782|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865783|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865784|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865785|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865786|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865787|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865788|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865789|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865790|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865791|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865792|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865793|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
917339|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
865795|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865796|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865797|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865798|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865799|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865800|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865801|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865802|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865803|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865804|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865805|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865806|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865807|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865808|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865809|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865810|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865811|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865812|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865813|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865814|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865815|NCT01189500|O2|Outcome|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28. A single oral dose of Tamoxifen 40 mg coadministered with the DVS SR dose on Period 2 / Day 7.
865816|NCT01189500|O1|Outcome|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose Period 1 / Day 1.
865817|NCT01189500|E3|Reported Event|Tamoxifen 40 mg + DVS SR 100 mg (Period 2)|Tamoxifen 40 mg as a single oral dose coadministered with DVS SR 100 mg as a single oral dose on Period 2 / Day 7.
865818|NCT01189500|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR 100 mg as a single oral daily dose Period 2 / Day 1 through Day 6 (steady state) and Day 7 through Day 28.
865819|NCT01189500|E1|Reported Event|Tamoxifen 40 mg (Period 1)|Tamoxifen 40 mg as a single oral dose on Period 1 / Day 1.
865820|NCT01189487|B1|Baseline|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
865821|NCT01189487|P1|Participant Flow|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
865822|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
866031|NCT01189032|O3|Outcome|High Concentration|3% DE-089 ophthalmic solution
865823|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
865824|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
865825|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
865826|NCT01189487|O1|Outcome|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
865827|NCT01189487|E1|Reported Event|Ampicillin Sodium/Sulbactam Sodium|Intravenous ampicillin sodium/sulbactam sodium 3 g four times a day (12 g/day) for 3 to 14 days
865828|NCT01189461|B1|Baseline|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
865829|NCT01189461|P1|Participant Flow|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
865830|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
865831|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
917340|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
865833|NCT01189461|O1|Outcome|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
865834|NCT01189461|E1|Reported Event|Macugen|Macugen (pegaptanib sodium) 0.3 milligram (mg) intravitreal injection administered once every 6 weeks into the study eye up to Week 48.
865835|NCT01189435|B1|Baseline|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
865836|NCT01189435|P1|Participant Flow|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
865837|NCT01189435|O1|Outcome|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
865838|NCT01189435|E1|Reported Event|Erlotinib|"This will be a single institution, single-arm, two-stage, open-label study of erlotinib in the treatment of patients with recurrent EGFR-mutant lung cancer following completion of adjuvant erlotinib or gefitinib therapy.~erlotinib: After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST."
865839|NCT01189370|B1|Baseline|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week~Sorafenib 600 mg twice daily, days 1-5 per week~Sorafenib 800 mg twice daily, days 1-5 per week~Sorafenib 1000 mg twice daily, says 1-5 per week"
865840|NCT01189370|P3|Participant Flow|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
865841|NCT01189370|P2|Participant Flow|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
865842|NCT01189370|P1|Participant Flow|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
865843|NCT01189370|O1|Outcome|Number of Participants With Disease Progression|Total number of participants that had disease progression while on study. Disease progression based on RECIST criteria.
865844|NCT01189370|O3|Outcome|Cohort 3: 800mg|Participants were administered 800mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
865845|NCT01189370|O2|Outcome|Cohort 2: 600 mg|Participants were administered 600mg of Sorafenib by mouth twice daily, days 1-5 of each week for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
865846|NCT01189370|O1|Outcome|Cohort 1: 400mg|Participants were administered 400 mg of Sorafenib by mouth twice daily for 4 weeks, and were evaluated at four weeks for toxicity. At four weeks, all participants who have not experienced Grade 3 or 4 toxicity will undergo dose escalation.
865847|NCT01189370|E1|Reported Event|Sorafenib|"Sorafenib 400 mg twice daily, 7 days a week~Sorafenib 600 mg twice daily, days 1-5 per week~Sorafenib 800 mg twice daily, days 1-5 per week"
865848|NCT01189292|B3|Baseline|Total|Total of all reporting groups
865849|NCT01189292|B2|Baseline|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
866032|NCT01189032|O2|Outcome|Low Concentration|1% DE-089 ophthalmic solution
865850|NCT01189292|B1|Baseline|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865851|NCT01189292|P2|Participant Flow|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865852|NCT01189292|P1|Participant Flow|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865853|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865854|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865855|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865856|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865857|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865963|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865858|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865859|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865860|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865861|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865862|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865863|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865864|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865865|NCT01189292|O2|Outcome|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865866|NCT01189292|O1|Outcome|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865867|NCT01189292|E2|Reported Event|Placebo (NaCl 0.9%)|NaCl 0.9%: 2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
865868|NCT01189292|E1|Reported Event|Dexamethasone Injection|"Administration of 8mg(2ml) intravenous Dexamethasone (Mephameson®)~Dexamethasone: 8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery"
865869|NCT01189279|B4|Baseline|Total|Total of all reporting groups
865870|NCT01189279|B3|Baseline|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
865871|NCT01189279|B2|Baseline|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865872|NCT01189279|B1|Baseline|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865873|NCT01189279|P3|Participant Flow|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
865874|NCT01189279|P2|Participant Flow|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865875|NCT01189279|P1|Participant Flow|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865876|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
865877|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865878|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865879|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
865880|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865881|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865882|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
865883|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865884|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865885|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
865886|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865887|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865888|NCT01189279|O3|Outcome|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
866033|NCT01189032|O1|Outcome|Placebo|Placebo ophthalmic solution
865889|NCT01189279|O2|Outcome|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865890|NCT01189279|O1|Outcome|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865891|NCT01189279|E3|Reported Event|Part 2: Bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
865892|NCT01189279|E2|Reported Event|Part 1: Bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
865893|NCT01189279|E1|Reported Event|Part 1: Bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
865894|NCT01189240|B1|Baseline|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865964|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
866314|NCT01188538|O1|Outcome|Epiduo® Gel|Epiduo® Gel Topical to the face, once daily application in the evening
865895|NCT01189240|P3|Participant Flow|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865896|NCT01189240|P2|Participant Flow|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865897|NCT01189240|P1|Participant Flow|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865898|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865899|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865900|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865901|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865902|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865903|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865904|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865921|NCT01189227|O1|Outcome|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
865905|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865906|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865965|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
866315|NCT01188538|O2|Outcome|Benzoyl Peroxide (BPO) Gel|
866316|NCT01188538|O1|Outcome|Epiduo Gel|
865907|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865908|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865909|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~For initial cycle (Cycle 1) bevacizumab was not given until 2 or 3 days after all PKs samples of initial dose of RO49290977 was collected~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865910|NCT01189240|O3|Outcome|Phase I Dose Finding Level 3 20mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 20mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865911|NCT01189240|O2|Outcome|Phase I Dose Finding Level 2 10mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 10mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865912|NCT01189240|O1|Outcome|Phase I Dose Finding - Level 1 5mg|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 5mg on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865913|NCT01189240|O1|Outcome|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865914|NCT01189240|E1|Reported Event|Phase I Dose Finding|"Patients receive oral gamma-secretase/Notch signalling pathway inhibitor RO49290977 on days 1-3, 8-10, 15-17, and 22-24, and bevacizumab IV over 30-90 minutes on days 1 and 15. Other: blood samples for pharmacological study; archived tumor tissue slides for laboratory biomarker analysis.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
865915|NCT01189227|B3|Baseline|Total|Total of all reporting groups
865916|NCT01189227|B2|Baseline|Perioperative Chemotherapy|Perioperative chemotherapy
865917|NCT01189227|B1|Baseline|Postoperative Chemotherapy|Postoperative chemotherapy
865918|NCT01189227|P2|Participant Flow|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
865919|NCT01189227|P1|Participant Flow|Arm 1: Postoperative Chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
865920|NCT01189227|O2|Outcome|Arm 2: Perioperative Chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
865922|NCT01189227|E2|Reported Event|Perioperative Chemotherapy|Perioperative chemotherapy
865923|NCT01189227|E1|Reported Event|Postoperative Chemotherapy|Postoperative chemotherapy
865924|NCT01189201|B1|Baseline|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
865966|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865967|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865925|NCT01189201|P1|Participant Flow|Study Overall|"A randomised, open label, three period, crossover trial. Each subject was to receive 3 of 4 possible treatments. The treatments were~Empagliflozin plus linagliptin fixed dose combination (FDC) A1 (fasted)~Empagliflozin plus linagliptin, individual tablets (fasted)~Empagliflozin plus linagliptin FDC A1 (fed)~Empagliflozin plus linagliptin FDC A3 (fasted)~Drug administrations were separated by a washout period of at least 35 days.~A total of 42 subjects were entered into the study, all subjects were allocated to the FDC A1 (fasted) and individual tablet treatments as this was the primary objective of the study. Along with this 18 of the subjects were allocated to receive the FDC A1 (fed) treatment and other 24 subjects to the FDC A3 treatment."
865926|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
865927|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865928|NCT01189201|O2|Outcome|Empa Plus Linagliptin Indivdual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865929|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865930|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
865931|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865932|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
865933|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865934|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
865935|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865936|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
865937|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865938|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
865939|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865940|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
865941|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865942|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865943|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865944|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865945|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865946|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865947|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865948|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865949|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865950|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865951|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865952|NCT01189201|O2|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865953|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865954|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865955|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865956|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865957|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865958|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
866030|NCT01189032|P1|Participant Flow|Placebo|Placebo ophthalmic solution
865959|NCT01189201|O3|Outcome|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865960|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865961|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865962|NCT01189201|O4|Outcome|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3.
865968|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865969|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865970|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865971|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865972|NCT01189201|O2|Outcome|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865973|NCT01189201|O1|Outcome|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865974|NCT01189201|E4|Reported Event|Empa Plus Linagliptin FDC A3 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg FDC tablet formulation A3 (FDC A3).
865975|NCT01189201|E3|Reported Event|Empa Plus Linagliptin FDC A1 (Fed)|A single dose of empa 25 mg and linagliptin 5 mg FDC A1 tablet given after a high-fat, high-caloric meal.
865976|NCT01189201|E2|Reported Event|Empa Plus Linagliptin Individual Tablets (Fasted)|Individual tablets of empa 25 mg and linagliptin 5 mg administered together
865977|NCT01189201|E1|Reported Event|Empa Plus Linagliptin FDC A1 (Fasted)|A single dose of empa 25 mg and linagliptin 5 mg fixed dose combination (FDC) tablet formulation A1 (FDC A1)
865978|NCT01189136|B3|Baseline|Total|Total of all reporting groups
865979|NCT01189136|B2|Baseline|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
865980|NCT01189136|B1|Baseline|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
865981|NCT01189136|P2|Participant Flow|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
865982|NCT01189136|P1|Participant Flow|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
865983|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
865984|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
865985|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
865986|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
865987|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
865988|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
865989|NCT01189136|O2|Outcome|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
865990|NCT01189136|O1|Outcome|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
865991|NCT01189136|E2|Reported Event|Peructaneous Tibial Nerve Stimulation|"Patient receives PTNS for 30 minutes~PTNS treatment: Electrical stimulation is received"
865992|NCT01189136|E1|Reported Event|Sham Treatment|"No electrical stimulation is actually received~Sham treatment: No electrical stimulation is given"
865993|NCT01189123|B3|Baseline|Total|Total of all reporting groups
865994|NCT01189123|B2|Baseline|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
865995|NCT01189123|B1|Baseline|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
865996|NCT01189123|P2|Participant Flow|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
865997|NCT01189123|P1|Participant Flow|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone~1 dose of vaccine was given IM"
865998|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
865999|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
866000|NCT01189123|O2|Outcome|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
866001|NCT01189123|O1|Outcome|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
866002|NCT01189123|E2|Reported Event|High Dose Vaccine|"High Dose Fluzone by sanofi pasteur~High dose influenza vaccine Sanofi-Pasteur: High dose influenza vaccine Sanofi-Pasteur at standard dosing (1 IM injection)"
866003|NCT01189123|E1|Reported Event|Standard Dose Influenza Vaccine|"Fluzone (Sanofi Pasteur)~fluzone by sanofi pasteur: standard dose fluzone"
866004|NCT01189110|B3|Baseline|Total|Total of all reporting groups
866005|NCT01189110|B2|Baseline|Arm 2|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
866006|NCT01189110|B1|Baseline|Arm 1|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
866007|NCT01189110|P2|Participant Flow|Arm 2|Placebo group- sham Stim Flex machine
866009|NCT01189110|O2|Outcome|Arm 2- Placebo|Receipt of sham auriculotherapy via a Stim Flex machine that disabled electrical flow of current to the ear probe.
866010|NCT01189110|O1|Outcome|Arm 1- Intervention|Receipt of auriculotherapy via a Stim Flex machine that provided full electrical flow of current to the ear probe.
866011|NCT01189110|E2|Reported Event|Arm 2- Placebo|Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
866012|NCT01189110|E1|Reported Event|Arm 1- Intervention|Two separate Stim Flex machines will be used in this study: Machine A (usual care) will be a usual functioning machine which is FDA approved; Machine B (sham treatment) will be altered to disable the electrical current to flow to the probe. Otherwise both machines will be identical and function identical except at the time the electrical current is given thru the probe. There is no alteration to the outside of either Stem Flex machines, the alteration to the sham machine will be internal, and will appear and sound identical to the Stim Flex machine which has not been altered.
866013|NCT01189071|B3|Baseline|Total|Total of all reporting groups
866014|NCT01189071|B2|Baseline|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
866015|NCT01189071|B1|Baseline|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
866016|NCT01189071|P2|Participant Flow|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
866017|NCT01189071|P1|Participant Flow|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
866018|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
866019|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
866020|NCT01189071|O2|Outcome|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
866021|NCT01189071|O1|Outcome|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
866022|NCT01189071|E2|Reported Event|no Pill|The control group will have the standard of care which is no preoperative anticholinegic medication.
866023|NCT01189071|E1|Reported Event|Darifenacin|"3 days of preoperative darifenacin anticholinergic medication~Darifenacin: an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery."
866024|NCT01189032|B4|Baseline|Total|Total of all reporting groups
866025|NCT01189032|B3|Baseline|High Concentration|3% DE-089 ophthalmic solution
866026|NCT01189032|B2|Baseline|Low Concentration|1% DE-089 ophthalmic solution
866027|NCT01189032|B1|Baseline|Placebo|Placebo ophthalmic solution
866028|NCT01189032|P3|Participant Flow|High Concentration|3% DE-089 ophthalmic solution
866029|NCT01189032|P2|Participant Flow|Low Concentration|1% DE-089 ophthalmic solution
866034|NCT01189032|E3|Reported Event|High Concentration|3% DE-089 ophthalmic solution
866035|NCT01189032|E2|Reported Event|Low Concentration|1% DE-089 ophthalmic solution
866036|NCT01189032|E1|Reported Event|Placebo|Placebo ophthalmic solution
866037|NCT01188967|B3|Baseline|Total|Total of all reporting groups
866038|NCT01188967|B2|Baseline|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received the active treatment: GSK598809 pills,60 mg/day.
866039|NCT01188967|B1|Baseline|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects were randomized with a block size of 4. This group received placebo pills.
866040|NCT01188967|P2|Participant Flow|Placebo Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
866084|NCT01188811|P2|Participant Flow|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
866317|NCT01188538|E2|Reported Event|Benzoyl Peroxide (BPO) Gel|
866041|NCT01188967|P1|Participant Flow|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received 60 mg GSK598809 pills, the active treatment, for 6 weeks.
866042|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
866043|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
866044|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
866045|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
866046|NCT01188967|O2|Outcome|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received GSK598809 pills, the active treatment.
866047|NCT01188967|O1|Outcome|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received placebo pills.
866048|NCT01188967|O2|Outcome|GSK598809 Treatment Group|
866049|NCT01188967|O1|Outcome|Placebo Treatment Group|
866050|NCT01188967|E2|Reported Event|GSK598809 Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the GSK598809 pills, the active treatment.
866051|NCT01188967|E1|Reported Event|Placebo Treatment Group|There is a 6-week, double-blind, placebo-controlled randomized treatment phase to evaluate the effect of study medication on craving, abstinence, and lapses to smoking. Eligible subjects will be randomized with a block size of 4. This group received the placebo pills.
866052|NCT01188928|B5|Baseline|Total|Total of all reporting groups
866053|NCT01188928|B4|Baseline|Topical Suspension Vehicle|The topical suspension vehicle alone
866054|NCT01188928|B3|Baseline|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
866055|NCT01188928|B2|Baseline|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
866056|NCT01188928|B1|Baseline|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
866057|NCT01188928|P4|Participant Flow|Topical Suspension Vehicle|The topical suspension vehicle alone
866058|NCT01188928|P3|Participant Flow|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
866059|NCT01188928|P2|Participant Flow|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
866060|NCT01188928|P1|Participant Flow|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
866061|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
866062|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
866063|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
866064|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
866065|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
866066|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
866067|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
866068|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
866069|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
866070|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
866071|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
866072|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
866073|NCT01188928|O4|Outcome|Topical Suspension Vehicle|The topical suspension vehicle alone
866074|NCT01188928|O3|Outcome|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
866075|NCT01188928|O2|Outcome|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
866076|NCT01188928|O1|Outcome|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
866077|NCT01188928|E4|Reported Event|Topical Suspension Vehicle|The topical suspension vehicle alone
866078|NCT01188928|E3|Reported Event|Calcipotriol|Calcipotriol 50 mcg/g in the topical suspension vehicle
866079|NCT01188928|E2|Reported Event|Betamethasone|Betamethasone 0.5 mg/g (as dipropionate) in the topical suspension vehicle
866080|NCT01188928|E1|Reported Event|LEO 80185|Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) topical suspension
866081|NCT01188811|B3|Baseline|Total|Total of all reporting groups
866082|NCT01188811|B2|Baseline|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
866083|NCT01188811|B1|Baseline|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
866085|NCT01188811|P1|Participant Flow|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
866086|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
866087|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
866088|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
866089|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
866090|NCT01188811|O2|Outcome|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
866091|NCT01188811|O1|Outcome|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
866092|NCT01188811|E2|Reported Event|Placebo|"28 subjects receive placebo daily~Placebo: The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation"
866093|NCT01188811|E1|Reported Event|Lipoic Acid|"28 subjects receive oral lipoic acid 1200mg daily~lipoic acid: 1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation."
866094|NCT01188798|B3|Baseline|Total|Total of all reporting groups
866095|NCT01188798|B2|Baseline|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866096|NCT01188798|B1|Baseline|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Methotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866097|NCT01188798|P2|Participant Flow|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866098|NCT01188798|P1|Participant Flow|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866099|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin).~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866100|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866139|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866140|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866141|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866101|NCT01188798|O2|Outcome|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866102|NCT01188798|O1|Outcome|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866103|NCT01188798|E2|Reported Event|Pentostatin|"Participants will be biologically stratified according to disease, donor, and KIR match between donor and host. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Pentostatin: Participants were randomized to receive pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866104|NCT01188798|E1|Reported Event|Methotrexate|"Participants will be biologically stratified according to disease, donor, and KIR match. In addition to a standard backbone of 2 GVHD prophylactics, a computer generated randomization procedure will assign participants to a third GVHD prophylactic medication (MTX or pentostatin)~Merthotrexate: Participants were randomized to receive methotrexate (MTX) for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor."
866105|NCT01188772|B5|Baseline|Total|Total of all reporting groups
866106|NCT01188772|B4|Baseline|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866107|NCT01188772|B3|Baseline|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866108|NCT01188772|B2|Baseline|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866109|NCT01188772|B1|Baseline|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866110|NCT01188772|P4|Participant Flow|Sofosbuvir 400 mg (Genotype 2/3)|Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks.
866111|NCT01188772|P3|Participant Flow|Placebo (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
866112|NCT01188772|P2|Participant Flow|Sofosbuvir 400 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
866113|NCT01188772|P1|Participant Flow|Sofosbuvir 200 mg (Genotype 1)|Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+pegylated interferon alfa-2a (PEG)+ribavirin (RBV) for 12 weeks followed by PEG+RBV for up to an additional 36 weeks.
866114|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866115|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866116|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866117|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866118|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866119|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866120|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866121|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866122|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866123|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866124|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866125|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866126|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866127|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866128|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866129|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866130|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866131|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866132|NCT01188772|O3|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866133|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866134|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for 36 additional weeks
866135|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866136|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866137|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866138|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866142|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866143|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866144|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866145|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866146|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866147|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866148|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866149|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866150|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866151|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866152|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866153|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866154|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866155|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866156|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866157|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866158|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866159|NCT01188772|O4|Outcome|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866160|NCT01188772|O3|Outcome|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866161|NCT01188772|O2|Outcome|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866162|NCT01188772|O1|Outcome|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866163|NCT01188772|E4|Reported Event|Sofosbuvir 400 mg (Genotype 2/3)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks
866164|NCT01188772|E3|Reported Event|Placebo (Genotype 1)|Placebo to match sofosbuvir+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866165|NCT01188772|E2|Reported Event|Sofosbuvir 400 mg (Genotype 1)|Sofosbuvir 400 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866166|NCT01188772|E1|Reported Event|Sofosbuvir 200 mg (Genotype 1)|Sofosbuvir 200 mg+PEG+RBV for 12 weeks; PEG+RBV for up to an additional 36 weeks
866167|NCT01188694|B4|Baseline|Total|Total of all reporting groups
866168|NCT01188694|B3|Baseline|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
866169|NCT01188694|B2|Baseline|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
866170|NCT01188694|B1|Baseline|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
866171|NCT01188694|P3|Participant Flow|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
866172|NCT01188694|P2|Participant Flow|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
866173|NCT01188694|P1|Participant Flow|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
866174|NCT01188694|O3|Outcome|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
866175|NCT01188694|O2|Outcome|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
866176|NCT01188694|O1|Outcome|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
866177|NCT01188694|E3|Reported Event|Delayed Psychotherapy|Delayed Psychotherapy: Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
866178|NCT01188694|E2|Reported Event|Psychotherapy Plus Placebo|Psychotherapy plus Placebo: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
866179|NCT01188694|E1|Reported Event|Psychotherapy Plus Methylene Blue, USP|Psychotherapy plus Methylene Blue, USP: This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
866201|NCT01188668|B1|Baseline|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1. DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866202|NCT01188668|P1|Participant Flow|Aripiprazole 5 mg, Aripiprazole 5 mg + DVS SR 100 mg|Aripiprazole (ARIP) as a single oral dose of 5 milligrams (mg) Period 1 / Day 1. Desvenlafaxine sustained release (DVS SR) as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866203|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866204|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866205|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866206|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866207|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866208|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866209|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866210|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866211|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866212|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866213|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866214|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866215|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866216|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866217|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866218|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866219|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866220|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866221|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866222|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866223|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866224|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866225|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866226|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866227|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866228|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866229|NCT01188668|O2|Outcome|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state) and Day 7 though 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866230|NCT01188668|O1|Outcome|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866231|NCT01188668|E3|Reported Event|Aripiprazole 5 mg + DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 7 though Day 19. Aripiprazole as a single oral dose of 5 mg coadministered with the DVS SR dose on Period 2 / Day 7.
866232|NCT01188668|E2|Reported Event|DVS SR 100 mg (Period 2)|DVS SR as a single oral dose of 100 mg Period 2 / Day 1 through Day 6 (steady state).
866233|NCT01188668|E1|Reported Event|Aripiprazole 5 mg (Period 1)|Aripiprazole as a single oral dose of 5 mg Period 1 / Day 1.
866234|NCT01188655|B1|Baseline|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866235|NCT01188655|P1|Participant Flow|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866236|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866237|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866308|NCT01188538|B3|Baseline|Total|Total of all reporting groups
866238|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866266|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
866267|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
892093|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
866239|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866240|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866241|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866242|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866243|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866244|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866245|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866246|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866247|NCT01188655|O1|Outcome|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866248|NCT01188655|E1|Reported Event|Etanercept|Participants were treated in accordance with the requirements of the labeling of Enbrel in Austria. The dosage and duration of therapy was to be determined by the physician to meet participant's individual needs for treatment. To record complete dosing information, initial dose was documented at baseline and any change was documented with date, dose and reason at the subsequent visits.
866249|NCT01188603|B1|Baseline|Flibanserin|100mg Flibanserin administered orally once daily
866250|NCT01188603|P1|Participant Flow|Flibanserin|100mg Flibanserin administered orally once daily
866251|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
866252|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
866253|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
866254|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
866255|NCT01188603|O1|Outcome|Flibanserin|100mg Flibanserin administered orally once daily
866256|NCT01188603|E1|Reported Event|Flibanserin|100mg Flibanserin administered orally once daily
866257|NCT01188577|B3|Baseline|Total|Total of all reporting groups
866258|NCT01188577|B2|Baseline|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
866259|NCT01188577|B1|Baseline|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
866260|NCT01188577|P2|Participant Flow|T, C|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
866309|NCT01188538|B2|Baseline|Benzoyl Peroxide (BPO) Gel|
866310|NCT01188538|B1|Baseline|Epiduo Gel|
866311|NCT01188538|P2|Participant Flow|Benzoyl Peroxide (BPO) Gel|
866312|NCT01188538|P1|Participant Flow|Epiduo Gel|
866261|NCT01188577|P1|Participant Flow|C, T|Subjects received one of the two treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T: Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
866262|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
866263|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
866264|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
866265|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
866268|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
866269|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
866270|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
866271|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
866272|NCT01188577|O2|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
866273|NCT01188577|O1|Outcome|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
866274|NCT01188577|E2|Reported Event|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min
866275|NCT01188577|E1|Reported Event|Treatment T|Ten (10) inhalations of E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min
866276|NCT01188564|B3|Baseline|Total|Total of all reporting groups
866277|NCT01188564|B2|Baseline|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
866278|NCT01188564|B1|Baseline|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
866279|NCT01188564|P2|Participant Flow|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
866280|NCT01188564|P1|Participant Flow|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
866281|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
866282|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
866283|NCT01188564|O2|Outcome|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
866284|NCT01188564|O1|Outcome|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
866285|NCT01188564|E2|Reported Event|Placebo (Saline)|Placebo (Saline): One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
866286|NCT01188564|E1|Reported Event|rhC1INH|rhC1INH: One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
866287|NCT01188551|B5|Baseline|Total|Total of all reporting groups
866288|NCT01188551|B4|Baseline|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
866289|NCT01188551|B3|Baseline|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
866290|NCT01188551|B2|Baseline|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
866291|NCT01188551|B1|Baseline|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
866292|NCT01188551|P4|Participant Flow|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
866293|NCT01188551|P3|Participant Flow|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
866294|NCT01188551|P2|Participant Flow|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
866295|NCT01188551|P1|Participant Flow|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
866296|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
866297|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
866298|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
866299|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
866300|NCT01188551|O4|Outcome|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
866301|NCT01188551|O3|Outcome|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
866302|NCT01188551|O2|Outcome|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
866303|NCT01188551|O1|Outcome|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
866304|NCT01188551|E4|Reported Event|Fentanyl w/o Midazolam|Fentanyl given intranasally in the OR without any pre-medication.
866305|NCT01188551|E3|Reported Event|Dexmedetomidine w/o Midazolam|Dexmedetomidine given intranasally in OR without any pre-medication.
866306|NCT01188551|E2|Reported Event|Fentanyl w/ Midazolam|Midazolam given orally pre-op and fentanyl given intranasally in OR.
866307|NCT01188551|E1|Reported Event|Dexmedetomidine w/ Midazolam|Midazolam given orally pre-op and dexmedetomidine given intranasally in OR.
866320|NCT01188499|B5|Baseline|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866321|NCT01188499|B4|Baseline|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866322|NCT01188499|B3|Baseline|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866323|NCT01188499|B2|Baseline|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866324|NCT01188499|B1|Baseline|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866325|NCT01188499|P5|Participant Flow|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866326|NCT01188499|P4|Participant Flow|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866327|NCT01188499|P3|Participant Flow|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866328|NCT01188499|P2|Participant Flow|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866329|NCT01188499|P1|Participant Flow|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866330|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866331|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866332|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866333|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866334|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866335|NCT01188499|O5|Outcome|Arm 5: Liposomal Doxorubicin|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866363|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866336|NCT01188499|O4|Outcome|Arm 4: Gemcitabine + TL32711|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866337|NCT01188499|O3|Outcome|Arm 3: Docetaxel + TL32711|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866338|NCT01188499|O2|Outcome|Arm 2: Irinotecan + TL32711|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866339|NCT01188499|O1|Outcome|Arm 1: Carboplatin/Paclitaxel + TL32711|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866340|NCT01188499|E5|Reported Event|Arm 5: Liposomal Doxorubicin + Birinapant|"Liposomal doxorubicin (40 mg/m2/IV) every 4 weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 weeks off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866341|NCT01188499|E4|Reported Event|Arm 4: Gemcitabine + Birinapant|"Gemcitabine (1000 mg/m2/IV) once weekly (7 days +/- 2 days) for 3 consecutive weeks followed by 1 week off + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 2 week off for each cycle (4 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by two weeks off repeated every 4 weeks as tolerated in combination with chemotherapy."
866342|NCT01188499|E3|Reported Event|Arm 3: Docetaxel + Birinapant|"Docetaxel (75 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866343|NCT01188499|E2|Reported Event|Arm 2: Irinotecan + Birinapant|"Irinotecan (350 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866344|NCT01188499|E1|Reported Event|Arm 1: Carboplatin/Paclitaxel + Birinapant|"Carboplatin (AUC 6/Paclitaxel (175 mg/m2/IV) once every 3 (q3) weeks + TL32711 once weekly (7 days +/- 2 days) for 2 consecutive weeks followed by 1 week off for each cycle (3 weeks per cycle).~TL32711: 30 minute intravenous (IV) infusion of TL32711 administered once weekly for two consecutive weeks followed by one week off repeated every 3 weeks as tolerated in combination with chemotherapy"
866345|NCT01188343|B4|Baseline|Total|Total of all reporting groups
866346|NCT01188343|B3|Baseline|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866347|NCT01188343|B2|Baseline|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
866348|NCT01188343|B1|Baseline|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866349|NCT01188343|P3|Participant Flow|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE CV vaccine on day 0
866350|NCT01188343|P2|Participant Flow|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
866351|NCT01188343|P1|Participant Flow|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866352|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866353|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
866354|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866355|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866356|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
866357|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866358|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866359|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
866360|NCT01188343|O1|Outcome|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866361|NCT01188343|O3|Outcome|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866362|NCT01188343|O2|Outcome|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
866364|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866365|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
866366|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866367|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866368|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
866369|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866370|NCT01188343|O3|Outcome|JE-CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866371|NCT01188343|O2|Outcome|MMR + JE-CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE-CV vaccine on day 42
866372|NCT01188343|O1|Outcome|JE-CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE-CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866373|NCT01188343|E3|Reported Event|JE CV/MMR (Group 3)|Participants 12 to 18 months of age received one dose each of MMR and JE-CV vaccine on day 0
866374|NCT01188343|E2|Reported Event|MMR + JE CV (Group 2)|Participants 12 to 18 months of age received one dose of MMR vaccine on day 0 and one dose of JE CV vaccine on day 42
866375|NCT01188343|E1|Reported Event|JE CV + MMR (Group 1)|Participants 12 to 18 months of age received one dose of Japanese encephalitis chimeric virus vaccine (JE CV) on day 0 and one dose of Measles, Mumps, and Rubella (MMR) vaccine on day 42
866376|NCT01188226|B1|Baseline|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
866377|NCT01188226|P1|Participant Flow|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
866378|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866379|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866380|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866381|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866382|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866383|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866384|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866385|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866386|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866387|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866388|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866389|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866390|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866391|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866392|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866393|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866394|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866395|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866396|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
866397|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|"Denture teeth are made of nano hybrid composite material~Denture teeth: Denture teeth made of nano hybrid composite material"
866398|NCT01188226|O1|Outcome|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
866399|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866400|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866401|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866402|NCT01188226|O3|Outcome|Left-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866403|NCT01188226|O2|Outcome|Right-posterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866404|NCT01188226|O1|Outcome|Anterior Denture Teeth|Denture teeth are made of nano hybrid composite material
866405|NCT01188226|O1|Outcome|Participants With Nano Hybrid Composite Dentures|Denture teeth are made of nano hybrid composite material
866406|NCT01188226|O2|Outcome|Lower Denture|Participants wearing lower denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
866407|NCT01188226|O1|Outcome|Upper Denture|Participants wearing upper denture 24 months after denture completion. Denture teeth are made of nano hybrid composite material.
866408|NCT01188226|O2|Outcome|Lower Denture|Participants with lower denture in use 18 months after denture completion. Denture teeth are made of nano hybrid composite material
866409|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
866410|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
866411|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
866412|NCT01188226|O2|Outcome|Lower Denture|Denture teeth are made of nano hybrid composite material
866413|NCT01188226|O1|Outcome|Upper Denture|Denture teeth are made of nano hybrid composite material
866414|NCT01188226|E1|Reported Event|Nano Hybrid Composite Denture Teeth|Denture teeth are made of nano hybrid composite material
866415|NCT01188109|B1|Baseline|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
866416|NCT01188109|P1|Participant Flow|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
866417|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
866418|NCT01188109|O1|Outcome|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
866419|NCT01188109|E1|Reported Event|Gemcitabine / Cisplatin|"Single arm study. All patients will receive gemcitabine and cisplatin as adjuvant therapy.~Gemcitabine: Standard of care chemotherapy and dosage~Dose - 1000 mg/m²~Schedule - Days 1 and 15; Q 28 days~Cisplatin: Dose - 50 mg/m²~Schedule - Days 1 and 15; Q 28 days"
866420|NCT01187953|B3|Baseline|Total|Total of all reporting groups
866421|NCT01187953|B2|Baseline|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
866422|NCT01187953|B1|Baseline|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
866423|NCT01187953|P2|Participant Flow|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
866424|NCT01187953|P1|Participant Flow|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
866425|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
866426|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
866427|NCT01187953|O2|Outcome|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
866428|NCT01187953|O1|Outcome|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
866429|NCT01187953|E2|Reported Event|Prograf (Tacrolimus)|"Starting total daily dose of 0.10 mg/kg administered in two equally divided doses, morning and evening, per product labeling. Doses will be adjusted according to whole blood tacrolimus trough levels. In the initial post-transplant period, plasma trough levels will be measured at 24 and 48 hours. Study drugs will be adjusted to maintain the whole blood pre-dose (trough) concentration of tacrolimus in the target range of 6 - 11 ng/mL for the first 30 days, then 4 - 11 ng/mL for the remainder of the study.~Prograf (tacrolimus): Administered per current product labeling"
866467|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866504|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866430|NCT01187953|E1|Reported Event|LCP-Tacro|"The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.~LCP-Tacro: Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels."
866431|NCT01187914|B1|Baseline|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
866432|NCT01187914|P1|Participant Flow|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
866433|NCT01187914|O1|Outcome|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
866434|NCT01187914|E1|Reported Event|Open Irrigation|Those individuals who had an ablation using open irrigation cooled-tip RF ablation.
866435|NCT01187901|B3|Baseline|Total|Total of all reporting groups
866436|NCT01187901|B2|Baseline|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866437|NCT01187901|B1|Baseline|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866438|NCT01187901|P2|Participant Flow|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866439|NCT01187901|P1|Participant Flow|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866440|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866441|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866442|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866443|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866444|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866445|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866446|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866447|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866448|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866449|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866450|NCT01187901|O2|Outcome|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866451|NCT01187901|O1|Outcome|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866452|NCT01187901|E2|Reported Event|Placebo|Placebo capsules matching erlotinib active comparator (Placebo A) once daily and placebo capsules matching sulindac active comparator (Placebo B) twice daily for 6 months
866453|NCT01187901|E1|Reported Event|Sulindac-erlotinib|Sulindac 150 mg twice daily in combination with erlotinib 75 mg per day for 6 months
866454|NCT01187550|B3|Baseline|Total|Total of all reporting groups
866455|NCT01187550|B2|Baseline|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866456|NCT01187550|B1|Baseline|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866457|NCT01187550|P2|Participant Flow|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866458|NCT01187550|P1|Participant Flow|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866459|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866460|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866461|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866462|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866463|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866464|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866465|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866466|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
867683|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
866468|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866469|NCT01187550|O2|Outcome|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866470|NCT01187550|O1|Outcome|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866471|NCT01187550|E2|Reported Event|Small for Gestational Age (SGA)|Participants in SGA group received Saizen (r-hGH) sc at the daily dose of 0.033 mg/kg body weight for 4 weeks.
866472|NCT01187550|E1|Reported Event|Appropriate for Gestational Age (AGA)|Participants in AGA group received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (sc) at the daily dose of 0.033 milligram/kilogram (mg/kg) body weight for 4 weeks.
866473|NCT01187511|B3|Baseline|Total|Total of all reporting groups
866474|NCT01187511|B2|Baseline|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866475|NCT01187511|B1|Baseline|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866476|NCT01187511|P2|Participant Flow|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866477|NCT01187511|P1|Participant Flow|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866478|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866479|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866480|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866481|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866482|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866483|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866484|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866485|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866486|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866487|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866488|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866489|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866490|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866491|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866492|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866493|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866494|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866495|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866496|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866497|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866498|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866499|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866500|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866501|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866502|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866503|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866630|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866505|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866506|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866507|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866508|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866509|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866510|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866511|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866512|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866513|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866514|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866515|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866516|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866517|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866518|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866519|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866520|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866521|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866522|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866523|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866524|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866525|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866526|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866527|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866528|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866529|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866530|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866531|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866532|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866533|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866534|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866535|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866536|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866537|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866538|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866539|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866540|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866541|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866542|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866543|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866544|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866545|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866546|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866547|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866548|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866549|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866550|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866551|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866552|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866553|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866554|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866555|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866556|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866557|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866558|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866559|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866560|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866561|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866562|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866563|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866564|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866565|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866566|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866567|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866568|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866569|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866570|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866571|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866572|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866573|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866574|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866575|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866576|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866577|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866578|NCT01187511|O2|Outcome|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866579|NCT01187511|O1|Outcome|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866580|NCT01187511|E2|Reported Event|Placebo|Placebo was given orally, once a day in the evening, for 21 days, in the form of four tablets that matched those of GSK561679
866581|NCT01187511|E1|Reported Event|GSK561679|GSK561679 was given orally, once a day in the evening, for 21 days, at a dose of 350mg, administered as four tablets consisting of 3 x 100mg tablets plus 1 x 50mg tablet.
866582|NCT01187498|B3|Baseline|Total|Total of all reporting groups
866583|NCT01187498|B2|Baseline|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866584|NCT01187498|B1|Baseline|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866585|NCT01187498|P2|Participant Flow|Drug Therapy|Individually titrated, extended-release oxybutynin chloride, 5-30mg
866586|NCT01187498|P1|Participant Flow|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866587|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866588|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866589|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866590|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866591|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866592|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866593|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866594|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866595|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866596|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866597|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866598|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866599|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866600|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866601|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866602|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866603|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866604|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866605|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866606|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866607|NCT01187498|O2|Outcome|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866608|NCT01187498|O1|Outcome|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866609|NCT01187498|E2|Reported Event|Drug Therapy|Individually titrated, extended release oxybutynin chloride
866610|NCT01187498|E1|Reported Event|Behavioral Training|Delayed voiding, urge suppression techniques, pelvic floor muscle training
866611|NCT01187433|B3|Baseline|Total|Total of all reporting groups
866612|NCT01187433|B2|Baseline|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866613|NCT01187433|B1|Baseline|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866614|NCT01187433|P2|Participant Flow|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866615|NCT01187433|P1|Participant Flow|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866616|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866617|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866618|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866619|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866620|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866621|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866622|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866623|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866624|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866625|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866626|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866627|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866628|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866629|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866631|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866632|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866633|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866634|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866635|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866636|NCT01187433|O2|Outcome|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866637|NCT01187433|O1|Outcome|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866638|NCT01187433|E2|Reported Event|Control Group|Participants received 3 injections of placebo, 1 injection each at 0, 6, and 12 months.
866639|NCT01187433|E1|Reported Event|CYD Dengue Vaccine Group|Participants received 3 injections of the CYD dengue vaccine, 1 injection each at 0, 6, and 12 months.
866640|NCT01187355|B3|Baseline|Total|Total of all reporting groups
866641|NCT01187355|B2|Baseline|Renu Fresh MPS|Multi-purpose contact lens solution
866642|NCT01187355|B1|Baseline|Alcon MPDS|Multi-purpose disinfecting contact lens solution
866643|NCT01187355|P2|Participant Flow|Renu Fresh MPS|Multi-purpose contact lens solution
866644|NCT01187355|P1|Participant Flow|Alcon MPDS|Multi-purpose disinfecting contact lens solution
866645|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
866646|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
866647|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
866648|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
866649|NCT01187355|O2|Outcome|Renu Fresh MPS|Multi-purpose contact lens solution
866650|NCT01187355|O1|Outcome|Alcon MPDS|Multi-purpose disinfecting contact lens solution
866651|NCT01187355|E2|Reported Event|Renu Fresh MPS|Multi-purpose contact lens solution
866652|NCT01187355|E1|Reported Event|Alcon MPDS|Multi-purpose disinfecting contact lens solution
866653|NCT01187043|B6|Baseline|Total|Total of all reporting groups
866654|NCT01187043|B5|Baseline|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866655|NCT01187043|B4|Baseline|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866656|NCT01187043|B3|Baseline|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866657|NCT01187043|B2|Baseline|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866658|NCT01187043|B1|Baseline|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866659|NCT01187043|P5|Participant Flow|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866660|NCT01187043|P4|Participant Flow|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866661|NCT01187043|P3|Participant Flow|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866662|NCT01187043|P2|Participant Flow|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866663|NCT01187043|P1|Participant Flow|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866664|NCT01187043|O5|Outcome|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866665|NCT01187043|O4|Outcome|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866666|NCT01187043|O3|Outcome|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866667|NCT01187043|O2|Outcome|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866668|NCT01187043|O1|Outcome|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866669|NCT01187043|E5|Reported Event|ARM 5|"12 mg proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866670|NCT01187043|E4|Reported Event|ARM 4|"9 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866671|NCT01187043|E3|Reported Event|ARM 3|"6 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866672|NCT01187043|E2|Reported Event|ARM 2|"3 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866673|NCT01187043|E1|Reported Event|ARM 1|"1 mg Proellex~Proellex: 1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)"
866674|NCT01187017|B1|Baseline|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
866675|NCT01187017|P1|Participant Flow|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
866676|NCT01187017|O1|Outcome|Response Rate at 6 Months|"Hematologic Response of Refractory Severe aplastic anemia (SAA) subjects to fludarabine and cyclophosphamide.~The refractory SAA subjects will receive fludarabine and cyclophosphamide. The blood counts will be evaluated to assess a hematologic response. The hematologic response will be defined as complete, partial or no response. The response will be evaluated at 6 months."
866677|NCT01187017|E1|Reported Event|Refractory SAA|Refractory Severe aplastic anemia (SAA) subjects
866678|NCT01187004|B3|Baseline|Total|Total of all reporting groups
866679|NCT01187004|B2|Baseline|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
866680|NCT01187004|B1|Baseline|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
867684|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
866681|NCT01187004|P2|Participant Flow|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
866682|NCT01187004|P1|Participant Flow|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
866683|NCT01187004|O2|Outcome|Control Group|patients who didn't develope ALI. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
866684|NCT01187004|O1|Outcome|ICU-LOS in Patients Developing ALI|Intensive care unit length of stay in patients developing acute lung injury. ICU length of stay was calculated up to 28 days, and patients who died before were considered as having the maximum value
866685|NCT01187004|O1|Outcome|Acute Lung Injury|Patients who developed acute lung injury (ALI) after cardiac surgery and during mechanical ventilation
866686|NCT01187004|E2|Reported Event|Control Group|patients who don't develop acute lung injury after cardiac surgery with cardiopulmonary by pass
866687|NCT01187004|E1|Reported Event|Acute Lung Injury (ALI) Group|patients who develop acute lung injury (ALI) after cardiac surgery with cardiopulmonary by pass
866688|NCT01186939|B1|Baseline|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
866689|NCT01186939|P1|Participant Flow|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
866690|NCT01186939|O1|Outcome|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
866691|NCT01186939|E1|Reported Event|Azacitidine|Azacitidine (study drug) plus best supportive care. Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
866692|NCT01186848|B1|Baseline|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
866693|NCT01186848|P1|Participant Flow|Subjects Receiving Split Body Treatment|"The unit of randomization was the individual side of a body within each subject to receive either 1550-nm erbium-doped fractionated laser treatment or the combination of the laser and ultrasound treatment for the treatment of striae.~Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side."
866694|NCT01186848|O2|Outcome|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
866695|NCT01186848|O1|Outcome|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
866696|NCT01186848|E2|Reported Event|Combination Treatment|Combination of micro-focused ultrasound and 1550nm-fractionated laser : The treated sites were randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side and the contralateral side received micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
866697|NCT01186848|E1|Reported Event|1550-nm Erbium-doped Fractionated Laser|1550-nm erbium-doped fractionated laser : Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
866698|NCT01186796|B3|Baseline|Total|Total of all reporting groups
866699|NCT01186796|B2|Baseline|Saline Group|"Subjects are given 3 consecutive weekly injections of Saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866700|NCT01186796|B1|Baseline|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866729|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866730|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866701|NCT01186796|P2|Participant Flow|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866702|NCT01186796|P1|Participant Flow|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866703|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866704|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866705|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866706|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866707|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866708|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866709|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866710|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
867685|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
866711|NCT01186796|O2|Outcome|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866712|NCT01186796|O1|Outcome|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866713|NCT01186796|E2|Reported Event|Saline Placebo Group|"Subjects are given 3 consecutive weekly injections of saline. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866714|NCT01186796|E1|Reported Event|Fulvestrant Group|"Subjects are given 3 consecutive weekly injections of Fulvestrant 250mg. On days 22-26 after the initial injection, secretagogue combinations are assigned in randomized double-blind order within-subject to include the following conditions:~(i) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h."
866715|NCT01186744|B7|Baseline|Total|Total of all reporting groups
866716|NCT01186744|B6|Baseline|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID or up to 28 weeks in Period C (Double-Blind Re-Treatment)
866717|NCT01186744|B5|Baseline|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866718|NCT01186744|B4|Baseline|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866719|NCT01186744|B3|Baseline|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866720|NCT01186744|B2|Baseline|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866721|NCT01186744|B1|Baseline|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866722|NCT01186744|P6|Participant Flow|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866723|NCT01186744|P5|Participant Flow|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866724|NCT01186744|P4|Participant Flow|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866725|NCT01186744|P3|Participant Flow|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866726|NCT01186744|P2|Participant Flow|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for up to 24 continuous weeks during Period A (Initial Treatment)
866727|NCT01186744|P1|Participant Flow|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for up to 24 continuous weeks during Period A (Initial Treatment)
866728|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866731|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866732|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866733|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866734|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866735|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866736|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866737|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866738|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866739|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866740|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866741|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866742|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866743|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866744|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866745|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866746|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866747|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866748|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866749|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866750|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866751|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866752|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866753|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866754|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866755|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866756|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866915|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866757|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866758|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866759|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866760|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866761|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866762|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866763|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866764|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866765|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866766|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866767|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866768|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866769|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866770|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866771|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866772|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866773|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866774|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866775|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866776|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866777|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866778|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866779|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866780|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866781|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866782|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867686|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
866783|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866784|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866785|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866786|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866787|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866788|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866789|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866790|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866791|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866792|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866793|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866794|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866795|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866796|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866797|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866798|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866799|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866800|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866801|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866802|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866803|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866804|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866805|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866806|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866807|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866808|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866968|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866809|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866810|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866811|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866812|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866813|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866814|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866815|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866816|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866817|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866818|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866819|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866820|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866821|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866822|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866823|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866824|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866825|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866826|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866827|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866828|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866829|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866830|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866831|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866832|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866833|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866834|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866835|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866836|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866837|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866838|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866839|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866840|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866841|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866842|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866843|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866844|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866845|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866846|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866847|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866848|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866849|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866850|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866851|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866852|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866853|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866854|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866855|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866856|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866857|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866858|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866859|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866860|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866861|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867687|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
866862|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866863|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866864|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866865|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866866|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866867|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866868|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866869|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866870|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866871|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866872|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866873|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866874|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866875|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866876|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866877|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866878|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866879|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866880|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866881|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866882|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866883|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866884|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866885|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866886|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866969|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866887|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866888|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866889|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866890|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866891|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866892|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866893|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866894|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866895|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866896|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866897|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866898|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866899|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866900|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866901|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866902|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866903|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866904|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866905|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866906|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866907|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866908|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866909|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866910|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866911|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866912|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866913|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866914|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866916|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866917|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866918|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866919|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866920|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866921|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866922|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866923|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866924|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866925|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866926|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866927|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866928|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866929|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866930|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866931|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866932|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866933|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866934|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866935|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866936|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866937|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866938|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866939|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866940|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866941|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867688|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
866942|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866943|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866944|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866945|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866946|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866947|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866948|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866949|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866950|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866951|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866952|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866953|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866954|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866955|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866956|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866957|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866958|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866959|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866960|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866961|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866962|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866963|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866964|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866965|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866966|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866967|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866970|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866971|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866972|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866973|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866974|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866975|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866976|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866977|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866978|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
866979|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866980|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866981|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866982|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866983|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866984|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866985|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866986|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866987|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866988|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment)
866989|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
866990|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866991|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866992|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866993|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
866994|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867222|NCT01185964|P4|Participant Flow|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
866995|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866996|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866997|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
866998|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
866999|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867000|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867001|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867002|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867003|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867004|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867005|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867006|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867007|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867008|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867009|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867010|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867011|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867012|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867013|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867014|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867015|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867016|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867017|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867018|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867019|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867020|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867432|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867021|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867022|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867023|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867024|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867025|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867026|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867027|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867028|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867029|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867030|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867031|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867032|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867033|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867034|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867035|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867036|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867037|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867038|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867039|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867040|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867041|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867042|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867043|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867044|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867045|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867223|NCT01185964|P3|Participant Flow|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867046|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867047|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867048|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867049|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867050|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867051|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867052|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867053|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867054|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867055|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867056|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867057|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867058|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867059|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867060|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867061|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867062|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867063|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867064|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867065|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867066|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867067|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867068|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867069|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867070|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867071|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867689|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867072|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867073|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867074|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867075|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867076|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867077|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867078|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867079|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867080|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867081|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867082|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867083|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867084|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867085|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867086|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867087|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867088|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867089|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867090|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867091|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867092|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867093|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867094|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867095|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
892094|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
867096|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867097|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867098|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867099|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867100|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867101|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867102|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867103|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867104|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867105|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867106|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867107|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867108|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867109|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867110|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550 BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867111|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867112|NCT01186744|O2|Outcome|Placebo for 5 mg CP-690,550 (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867113|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867114|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867115|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867116|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867117|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867118|NCT01186744|O2|Outcome|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867119|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period A)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867120|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867121|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867122|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants received placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
892095|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
867123|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867124|NCT01186744|O4|Outcome|Placebo BID / CP-690,550 10 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867125|NCT01186744|O3|Outcome|CP-690,550 10 mg BID / CP-690,550 10 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867126|NCT01186744|O2|Outcome|Placebo BID / CP-690,550 5 mg BID|Participants placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867127|NCT01186744|O1|Outcome|CP-690,550 5 mg BID / CP-690,550 5 mg BID|Participants received CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg tablets orally BID for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867128|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867129|NCT01186744|O3|Outcome|CP-690,550 10 mg BID (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867130|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867131|NCT01186744|O1|Outcome|CP-690,550 5 mg BID (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 5 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867132|NCT01186744|O4|Outcome|Placebo for 10 mg CP-690,550|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867133|NCT01186744|O3|Outcome|CP-690,550 10 mg (Period B)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP-690,550 10 mg BID for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867134|NCT01186744|O2|Outcome|Placebo for CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867135|NCT01186744|O1|Outcome|CP-690,550 5 mg (Period B)|Participants received CP-690,550 5 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment) followed by CP690-550 5 mg for 4, 8, 12, or 16 weeks during Period B (Double-Blind Treatment Withdrawal)
867136|NCT01186744|E6|Reported Event|CP-690,550 10 mg / Placebo / CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867137|NCT01186744|E5|Reported Event|CP-690,550 10 mg/CP-690,550 10 mg/CP-690,550 10 mg|Participants received CP-690,550 10 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 10 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 10 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867138|NCT01186744|E4|Reported Event|CP-690,550 5 mg/Placebo/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by placebo tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867139|NCT01186744|E3|Reported Event|CP-690,550 5 mg/CP-690,550 5 mg/CP-690,550 5 mg|Participants received CP-690,550 5 mg tablets orally BID for 24 weeks in Period A (Initial Treatment) followed by CP-690,550 5 mg tablets orally BID for 4, 8, 12 or 16 weeks during Period B (Double-Blind Treatment Withdrawal) followed by CP-690,550 5 mg for up to 28 weeks in Period C (Double-Blind Re-Treatment)
867140|NCT01186744|E2|Reported Event|CP-690,550 10 mg BID (Period A)|Participants received CP-690,550 10 mg tablets orally BID for 24 continuous weeks during Period A (Initial Treatment)
867141|NCT01186744|E1|Reported Event|CP-690,550 5 mg BID (Period A)|Participants received CP-690,550 5 milligram (mg) tablets orally twice daily (BID) for 24 continuous weeks during Period A (Initial Treatment)
867142|NCT01186705|B1|Baseline|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
867143|NCT01186705|P1|Participant Flow|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
867144|NCT01186705|O1|Outcome|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
867224|NCT01185964|P2|Participant Flow|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
867145|NCT01186705|E1|Reported Event|MK-2206|"This will be a single-arm, phase II study of the AKT inhibitor MK-2206 in patients with KRAS-wild-type, PIK3CA-mutated, colorectal cancer whose tumors have progressed through standard chemotherapy regimens.~MK-2206: Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects."
867146|NCT01186692|B1|Baseline|Enrolled Cohort|All subjects enrolled.
867147|NCT01186692|P1|Participant Flow|Enrolled|All subjects enrolled (n=131)
867148|NCT01186692|O1|Outcome|Implanted > 24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
867149|NCT01186692|O1|Outcome|Implanted Cohort|The implanted cohort consists of all subjects who underwent catheterization and a Melody TPV was implanted.
867150|NCT01186692|O1|Outcome|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
867151|NCT01186692|O1|Outcome|Attempted Implant Cohort|The attempted implant cohort consists of all subjects who underwent catheterization and a Melody TPV implantation was attempted (Melody TPV valve opened).
867152|NCT01186692|O1|Outcome|Implanted >24 Hours Cohort|The implanted >24 hours cohort consists of all subjects who had a Melody TPV implanted which remained implanted for greater than 24 hours.
867153|NCT01186692|E1|Reported Event|Catheterized Cohort|The catheterized cohort consists of all subjects who underwent catheterization for possible implantation of the Melody TPV.
867154|NCT01186562|B3|Baseline|Total|Total of all reporting groups
867155|NCT01186562|B2|Baseline|Placebo|Placebo: Placebo
867156|NCT01186562|B1|Baseline|Sitagliptin|Sitagliptin: 100 mg PO daily
867157|NCT01186562|P2|Participant Flow|Placebo|Placebo: Placebo
867158|NCT01186562|P1|Participant Flow|Sitagliptin|Sitagliptin: 100 mg PO daily
867159|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
867160|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
867161|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
867162|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
867163|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
867164|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
867165|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
867166|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
867167|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
867168|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
867169|NCT01186562|O2|Outcome|Placebo|Placebo: Placebo
867170|NCT01186562|O1|Outcome|Sitagliptin|Sitagliptin: 100 mg PO daily
867171|NCT01186562|E2|Reported Event|Placebo|Placebo: Placebo
867172|NCT01186562|E1|Reported Event|Sitagliptin|Sitagliptin: 100 mg PO daily
867173|NCT01186458|B1|Baseline|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
867174|NCT01186458|P1|Participant Flow|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
867175|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
867176|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
867177|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
867178|NCT01186458|O1|Outcome|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
867179|NCT01186458|E1|Reported Event|Fludarabine, Velcade and Rituximab|"Fludarabine, Velcade and Rituximab~Fludarabine: Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.~Velcade: Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.~Rituximab: Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy."
867180|NCT01186419|B3|Baseline|Total|Total of all reporting groups
867181|NCT01186419|B2|Baseline|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
892096|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
867182|NCT01186419|B1|Baseline|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
867183|NCT01186419|P2|Participant Flow|SPD602 32 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
867184|NCT01186419|P1|Participant Flow|SPD602 16 mg/kg/Day|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
867185|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
867186|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
867187|NCT01186419|O1|Outcome|SPD602|Participants received SPD602 orally once daily for up to 96 weeks.
867188|NCT01186419|E2|Reported Event|SPD602 32 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
867189|NCT01186419|E1|Reported Event|SPD602 16 mg/kg/d|Participants received SPD602 orally once daily for up to 96 weeks. At Week 24, the iron clearing activity of SPD602 was assessed for each participant and the dose may have been adjusted to a higher or lower dose if the clinical response was deemed insufficient or too robust, respectively (maximum dose=60mg/kg/day; minimum dose=8mg/kg/day). Participants not dose adjusted at Week 24 may also have had later dose adjustments to a higher or lower dose.
867190|NCT01186406|B1|Baseline|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
867191|NCT01186406|P1|Participant Flow|Gliadel, Radiation Therapy, Avastin, Temodar|"Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation~Gliadel, Radiation Therapy, Avastin, Temodar: Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, they will be treated with standard radiation therapy, and daily Temodar (75mg/m2) for 6.5 weeks of radiation. In addition, Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.~Beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with Avastin (10 mg/kg) every 14 days along with 5 day Temodar (200 mg/ m2)."
867192|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
867193|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
867225|NCT01185964|P1|Participant Flow|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867226|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
867227|NCT01185964|O2|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
867194|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
867195|NCT01186406|O1|Outcome|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
867196|NCT01186406|E1|Reported Event|Gliadel, Radiation Therapy, Avastin, Temodar|Single arm study where patients with newly diagnosed Grade IV malignant glioma will receive Gliadel at the time of resection, followed by radiation therapy (XRT), Avastin, and Temodar for approximately 6 1/2 weeks, followed by Avastin and Temodar post-radiation. Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy. Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively. Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days. At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation.
867197|NCT01186250|B3|Baseline|Total|Total of all reporting groups
867198|NCT01186250|B2|Baseline|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867199|NCT01186250|B1|Baseline|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867200|NCT01186250|P2|Participant Flow|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867201|NCT01186250|P1|Participant Flow|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867202|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867203|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867204|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867205|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867206|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867207|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867208|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867209|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867210|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867211|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867212|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867213|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867214|NCT01186250|O2|Outcome|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867215|NCT01186250|O1|Outcome|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867216|NCT01186250|E2|Reported Event|Placebo|"Placebo~Placebo: placebo taken daily for one year"
867217|NCT01186250|E1|Reported Event|Pioglitazone|"Pioglitazone~Pioglitazone: 15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months"
867218|NCT01185964|B4|Baseline|Total|Total of all reporting groups
867219|NCT01185964|B3|Baseline|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867220|NCT01185964|B2|Baseline|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
867221|NCT01185964|B1|Baseline|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867367|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867228|NCT01185964|O1|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867229|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867230|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867231|NCT01185964|O1|Outcome|Phase 1b and Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867232|NCT01185964|O1|Outcome|Phase 1b and Phase 2 Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867233|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867234|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
867235|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
867236|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867237|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
867238|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867239|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
867240|NCT01185964|O3|Outcome|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
867241|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867242|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle."
867243|NCT01185964|O1|Outcome|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle~Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle."
867244|NCT01185964|O2|Outcome|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867245|NCT01185964|O1|Outcome|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression: Olaratumab 15 mg/kg on days 1+8~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle~Doxorubicin 75 mg/m2 by IV on day 1 of the 21-day cycle."
867246|NCT01185964|E4|Reported Event|Phase 2: Doxorubicin: Optional Olaratumab After Progression|All subsequent cycles: Participants from doxorubicin monotherapy arm received optional Olaratumab 15 mg/kg on days 1+8 of a 21-day cycle.
867247|NCT01185964|E3|Reported Event|Phase 2: Doxorubicin|"All cycles are 21 days.~Cycles 1-8: doxorubicin 75 mg/m2 on day 1~At disease progression: optional Olaratumab 15 mg/kg on days 1+8 until further progression."
867248|NCT01185964|E2|Reported Event|Phase 2: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 mg/kg on days 1+8, and doxorubicin 75 mg/m2 on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by IV on days 1+8 of a 21-day cycle"
867249|NCT01185964|E1|Reported Event|Phase 1b: Olaratumab + Doxorubicin|"All cycles are 21 days.~Cycles 1-8: Olaratumab 15 milligram/kilogram (mg/kg) on days 1+8, and doxorubicin 75 milligram/square meter (mg/m2) on day 1~All subsequent cycles until progression:~Olaratumab 15 mg/kg by intravenous IV on days 1+8 of a 21-day cycle"
867250|NCT01185834|B1|Baseline|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
867251|NCT01185834|P1|Participant Flow|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
867252|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
867253|NCT01185834|O1|Outcome|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
867690|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867254|NCT01185834|E1|Reported Event|Lotrafilcon A|Lotrafilcon A lenses worn for 3 months, replaced monthly. Lenses worn on the same basis as habitual lenses, as prescribed by eye care practitioner (e.g., daily wear, flexible wear, extended wear up to 30 continuous nights).
867255|NCT01185782|B3|Baseline|Total|Total of all reporting groups
867256|NCT01185782|B2|Baseline|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867257|NCT01185782|B1|Baseline|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867258|NCT01185782|P2|Participant Flow|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867259|NCT01185782|P1|Participant Flow|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867260|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867261|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867262|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867263|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867264|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867265|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867266|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867267|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867268|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867269|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867270|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867271|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867272|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867273|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867274|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867368|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867275|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867276|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867277|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867278|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867279|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867280|NCT01185782|O2|Outcome|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867281|NCT01185782|O1|Outcome|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867282|NCT01185782|E2|Reported Event|u-hFSH|Urinary human follicle stimulating hormone (u-hFSH), a purified pituitary gonadotropin, was administered s.c. at a starting dose of 75 IU/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867283|NCT01185782|E1|Reported Event|SJ-0021|SJ-0021 (recombinant follitropin alfa) was administered subcutaneously (s.c.) at a starting dose of 75 International Unit (IU)/day which was to be followed by incremental doses of 37.5 IU on Days 8, 15 and 22 if the mean dominant follicle diameter was less than 11 mm. The maximum duration of treatment was 28 days.
867284|NCT01185704|B3|Baseline|Total|Total of all reporting groups
867285|NCT01185704|B2|Baseline|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867286|NCT01185704|B1|Baseline|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867287|NCT01185704|P2|Participant Flow|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867288|NCT01185704|P1|Participant Flow|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867289|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867290|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867291|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867292|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867369|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867691|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867293|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867294|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867295|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867296|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867297|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867298|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867299|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867300|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867301|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867302|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867303|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867304|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867305|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867306|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867307|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867325|NCT01185600|P1|Participant Flow|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
892097|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
867308|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867309|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867310|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867311|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867312|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867313|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867314|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867315|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867316|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867317|NCT01185704|O2|Outcome|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867318|NCT01185704|O1|Outcome|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867319|NCT01185704|E2|Reported Event|Day 7 Protocol|Cetrotide® 0.25 mg was administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) along with r-hFSH at a dose between 75 and 187.5 IU subcutaneously once daily from Day 2 (S1) until r-hCG administration day (at least 2 follicles >= 19 mm). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867320|NCT01185704|E1|Reported Event|Day 1 Protocol|Cetrotide® 0.25 milligram (mg) was administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) along with Recombinant human follicle stimulating hormone (r-hFSH) at a dose between 75 and 187.5 international unit (IU) subcutaneously once daily from Day 2 (Day 1 of stimulation period [S1]) until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 2 follicles greater than or equal to (>=) 17 millimeter [mm]). On r-hCG day, 250 microgram of r-hCG was administered once subcutaneously.
867321|NCT01185600|B3|Baseline|Total|Total of all reporting groups
867322|NCT01185600|B2|Baseline|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867323|NCT01185600|B1|Baseline|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867324|NCT01185600|P2|Participant Flow|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867326|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867327|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867328|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867329|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867330|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm will be transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867331|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subject assigned to this arm will be transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867332|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867333|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867334|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867335|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867336|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867337|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867338|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867339|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency,or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867340|NCT01185600|O2|Outcome|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867341|NCT01185600|O1|Outcome|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867342|NCT01185600|E2|Reported Event|Transfusion With Unwashed RBC|"Subjects assigned to this arm were transfused with unwashed RBC~Unwashed RBC: There is no pre-set dosage, frequency, or duration for transfusion with unwashed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject."
867343|NCT01185600|E1|Reported Event|Transfusion With Washed RBC|"Subjects assigned to this arm were transfused with washed RBC~Washed RBC: There is no pre-set dosage, frequency, or duration for transfusion with washed RBC. It all depends on the conditions of the patient during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject."
867344|NCT01185561|B3|Baseline|Total|Total of all reporting groups
867345|NCT01185561|B2|Baseline|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
867366|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867692|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867346|NCT01185561|B1|Baseline|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
867347|NCT01185561|P2|Participant Flow|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
867348|NCT01185561|P1|Participant Flow|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
867349|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
867350|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
867351|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
867352|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
867353|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
867354|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
867355|NCT01185561|O2|Outcome|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
867356|NCT01185561|O1|Outcome|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
867357|NCT01185561|E2|Reported Event|Usual Medical Care|Participants assigned to this arm represent the control group and will receive usual medical care only.
867358|NCT01185561|E1|Reported Event|Psychoeducational Intervention|"Participants assigned to this arm represent the experimental group and will receive group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes~Psychoeducational intervention: The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills."
867359|NCT01185522|B1|Baseline|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867360|NCT01185522|P1|Participant Flow|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867361|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867362|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867363|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867364|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867365|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867370|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867371|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867372|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867373|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867374|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867375|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867376|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867377|NCT01185522|O1|Outcome|Tocilizumab|Participants who received tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867378|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867379|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867380|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867381|NCT01185522|O1|Outcome|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867382|NCT01185522|E1|Reported Event|Tocilizumab|Eligible participants who were receiving tocilizumab according to summary of product characteristics in a real life setting were observed for 4 months.
867383|NCT01185509|B3|Baseline|Total|Total of all reporting groups
867384|NCT01185509|B2|Baseline|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867385|NCT01185509|B1|Baseline|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867386|NCT01185509|P2|Participant Flow|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867387|NCT01185509|P1|Participant Flow|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867388|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867400|NCT01185353|B2|Baseline|2 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
892098|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
867389|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867390|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867391|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867392|NCT01185509|O2|Outcome|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867393|NCT01185509|O1|Outcome|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867394|NCT01185509|E2|Reported Event|Trastuzumab and Vinorelbine - Main Cohort|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867395|NCT01185509|E1|Reported Event|Trastuzumab and Vinorelbine - Cohort A|Cycle 1: Patients received trastuzumab 8 mg/kg intravenously (IV) on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Cycles 2+: Patients received trastuzumab 6 mg/kg IV on day 1 and vinorelbine 25 mg/kg IV on days 1, 8 and 15 of each 21 day cycle Patients were treated until disease progression or unacceptable toxicity. Eligibility required patients to have HER2 amplification by FISH (mean ratio > 2.0). The CTC tests of the first 11 patients were done at DFCI. The study team then decided to proceed with a different CTC test performed outside of DFCI. Because the method of CTC isolation was different from that performed by DFCI, the first 11 patients were placed into a separate cohort (Cohort A) and the remaining 20 patients represented the main cohort.
867396|NCT01185353|B6|Baseline|Total|Total of all reporting groups
867397|NCT01185353|B5|Baseline|Placebo|"Placebo administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
867398|NCT01185353|B4|Baseline|8 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
867399|NCT01185353|B3|Baseline|4 mg LY3009104|"Administered orally QD for 24 weeks (Parts A and B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
892099|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
867401|NCT01185353|B1|Baseline|1 mg LY3009104|"Administered orally QD for initial 12 weeks (Part A) followed by randomization to either 4 mg QD or 2 mg BID for an additional 12 weeks (Part B). After 24 weeks of treatment, participants were eligible to participate in an open-label extension period (Part C). Part C: 4 mg or 8 mg administered orally QD for 52 weeks. After 76 weeks of treatment, participants were eligible to participate in an additional open-label extension period (Part D). Part D: 4 mg administered orally QD for 52 additional weeks.~MTX was administered orally as background therapy."
867402|NCT01185353|P10|Participant Flow|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.~Participants who completed Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867403|NCT01185353|P9|Participant Flow|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~At Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Participants who completed Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867404|NCT01185353|P8|Participant Flow|4 mg LY3009104 QD - Parts C and D|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~Participants who completed Part C continued to receive 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867405|NCT01185353|P7|Participant Flow|4 mg LY3009104 QD - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
867406|NCT01185353|P6|Participant Flow|2 mg LY3009104 BID - Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 twice daily (BID) in Part B.~MTX was administered orally as background therapy."
867407|NCT01185353|P5|Participant Flow|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867408|NCT01185353|P4|Participant Flow|8 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867409|NCT01185353|P3|Participant Flow|4 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867410|NCT01185353|P2|Participant Flow|2 mg LY3009104 QD - Parts A and B|"Administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867411|NCT01185353|P1|Participant Flow|1 Milligrams (mg) LY3009104 QD - Part A|"Administered orally once daily (QD) for 12 weeks in Part A.~Methotrexate (MTX) was administered orally as background therapy."
867412|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867413|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867414|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867415|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867416|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867417|NCT01185353|O4|Outcome|8 mg LY3009104|8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
867418|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
867419|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
867420|NCT01185353|O1|Outcome|1mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
867421|NCT01185353|O4|Outcome|8 mg LY3009104|8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B. MTX was administered orally as background therapy.
867422|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
867423|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
867424|NCT01185353|O1|Outcome|1 mg LY3009104|1 mg LY3009104 administered orally QD for 12 weeks in Part A. MTX was administered orally as background therapy.
867425|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867426|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867427|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867428|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867429|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867430|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867431|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867433|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867434|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867435|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867436|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867437|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867438|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867439|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867440|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867441|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867442|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867443|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867444|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867445|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867446|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867447|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867448|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867449|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867450|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867451|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867452|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867453|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867454|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥ 6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867455|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867456|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867457|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867458|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867459|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867460|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867461|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867462|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867463|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867464|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867465|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867466|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867467|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867468|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867469|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867470|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867471|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867472|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867473|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867474|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867475|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867476|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867477|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867478|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867479|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867480|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867481|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867482|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867483|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867484|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867485|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867486|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867487|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867488|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867489|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867490|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867491|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867492|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867493|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867526|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867632|NCT01185301|E1|Reported Event|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867494|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867495|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867496|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867497|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867498|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867499|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867500|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867501|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867502|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867503|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867504|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867505|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867506|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867507|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867508|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867509|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867510|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867511|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867512|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867513|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867514|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867515|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867516|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867517|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867518|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867519|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867520|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867521|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867522|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867523|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867524|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867525|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867527|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867528|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867529|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867530|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867531|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867532|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867533|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867534|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867535|NCT01185353|O3|Outcome|8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received 8 mg LY3009104 QD in Parts A, B and C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867536|NCT01185353|O2|Outcome|4 to 8 mg LY3009104 QD - Part C and 4 mg LY3009104 QD - Part D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C. During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD for the rest of the Part C.~Dose escalation criteria: ≥6 tender and 6 swollen joints based on the 28-joint count assessments and the clinical judgment of the investigator.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867537|NCT01185353|O1|Outcome|4 mg LY3009104 QD - Parts C and D|"Received Placebo, or 1 mg, or 2 mg, or 4 mg LY3009104 in Part A.~Received 2 mg LY3009104 QD, or BID, or 4 mg LY3009104 QD in Part B.~Received 4 mg LY3009104 QD in Part C.~Received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867538|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867539|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867540|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867541|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 24 weeks in Parts A and B.~MTX was administered orally as background therapy."
867542|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867543|NCT01185353|O5|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867544|NCT01185353|O4|Outcome|8 mg LY3009104|"8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867545|NCT01185353|O3|Outcome|4 mg LY3009104|"4 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867546|NCT01185353|O2|Outcome|2 mg LY3009104|"2 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867547|NCT01185353|O1|Outcome|1 mg LY3009104|"1 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867548|NCT01185353|O2|Outcome|Placebo|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867549|NCT01185353|O1|Outcome|4 or 8 mg LY3009104|"4 or 8 mg LY3009104 administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867550|NCT01185353|E18|Reported Event|Follow-Up|"Up to 28 days post the last dose of study drug.~MTX was administered orally as background therapy."
867551|NCT01185353|E17|Reported Event|8/4 mg LY3009104 QD - Part D|"Participants who received 8 mg LY3009104 QD in Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867552|NCT01185353|E16|Reported Event|4 mg LY3009104 QD (4 to 8 mg Rescue)- Part D|"Participants who received 8 mg LY3009104 QD rescue treatment in Part C received 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867553|NCT01185353|E15|Reported Event|4 mg LY3009104 QD - Part D|"Participants who received 4 mg LY3009104 QD in Part C continued to receive 4 mg LY3009104 QD in Part D.~MTX was administered orally as background therapy."
867554|NCT01185353|E14|Reported Event|8 mg LY3009104 QD - Part C|"Participants who received 8 mg LY3009104 QD in Part B remained on 8 mg LY3009104 QD in Part C.~MTX was administered orally as background therapy."
867555|NCT01185353|E13|Reported Event|4 to 8 mg LY3009104 QD Post-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.~MTX was administered orally as background therapy.~Adverse events were collected from predose of 8 mg LY3009104 QD until Week 76."
867591|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867592|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867633|NCT01185288|B3|Baseline|Total|Total of all reporting groups
867693|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867556|NCT01185353|E12|Reported Event|4 to 8 mg LY3009104 QD Pre-Rescue - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~During Part C, at Weeks 28 and 32, participants who met dose escalation criteria received 8 mg LY3009104 QD (rescue treatment) for the rest of the Part C.~MTX was administered orally as background therapy.~Adverse events were collected from Week 24 until predose of 8 mg LY3009104 QD."
867557|NCT01185353|E11|Reported Event|4 mg LY3009104 QD - Part C|"Participants who received 2 mg LY3009104 QD or BID in Part B were re-assigned at Week 24 to 4 mg LY3009104 QD in Part C.~Participants who received 4 mg LY3009104 QD in Part B continued to receive 4 mg LY3009104 QD in Part C.~MTX was administered orally as background therapy."
867558|NCT01185353|E10|Reported Event|8 mg LY3009104 QD - Part B|"Participants who received 8 mg LY3009104 QD in Part A continued to receive 8 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
867559|NCT01185353|E9|Reported Event|4 mg LY3009104 QD - Part B|"Participants who received 4 mg LY3009104 QD in Part A continued to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
867560|NCT01185353|E8|Reported Event|2 mg LY3009104 QD - Part B|"Participants who received 2 mg LY3009104 QD in Part A continued to receive 2 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
867561|NCT01185353|E7|Reported Event|4 mg LY3009104 QD Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 4 mg LY3009104 QD in Part B.~MTX was administered orally as background therapy."
867562|NCT01185353|E6|Reported Event|2 mg LY3009104 BID Crossover- Part B|"Participants who received Placebo or 1 mg LY3009104 in Part A were re-randomized at Week 12 to receive 2 mg LY3009104 BID in Part B.~MTX was administered orally as background therapy."
867563|NCT01185353|E5|Reported Event|Placebo QD - Part A|"Placebo administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867564|NCT01185353|E4|Reported Event|8 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867565|NCT01185353|E3|Reported Event|4 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Pat A.~MTX was administered orally as background therapy."
867566|NCT01185353|E2|Reported Event|2 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867567|NCT01185353|E1|Reported Event|1 mg LY3009104 QD - Part A|"Administered orally QD for 12 weeks in Part A.~MTX was administered orally as background therapy."
867568|NCT01185301|B5|Baseline|Total|Total of all reporting groups
867569|NCT01185301|B4|Baseline|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867570|NCT01185301|B3|Baseline|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867571|NCT01185301|B2|Baseline|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867572|NCT01185301|B1|Baseline|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867573|NCT01185301|P4|Participant Flow|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867574|NCT01185301|P3|Participant Flow|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867575|NCT01185301|P2|Participant Flow|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867576|NCT01185301|P1|Participant Flow|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867577|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867578|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867579|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867580|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867581|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867582|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867583|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867584|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867585|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867586|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867587|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867588|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867589|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867590|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867681|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867593|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867594|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867595|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867596|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867597|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867598|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867599|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867600|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867601|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867602|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867603|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867604|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867605|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867606|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867607|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867608|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867609|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867610|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867611|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867612|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867613|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867614|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867615|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867616|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867617|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867618|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867619|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867620|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867621|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867622|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867623|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867624|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867625|NCT01185301|O4|Outcome|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867626|NCT01185301|O3|Outcome|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867627|NCT01185301|O2|Outcome|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867628|NCT01185301|O1|Outcome|ADA + 2.5 mg MTX|2.5 mg methotrexate (MTX) oral capsule weekly with 40 mg adalimumab (ADA) subcutaneous (SC) injection every other week (EOW) for 26 weeks
867629|NCT01185301|E4|Reported Event|ADA + 20 mg MTX|MTX oral capsule dose escalation from 10 mg to 20 mg in 2.5 mg increments every other week (10 mg x 2 weeks, 12.5 mg x 2 weeks, 15 mg x 2 weeks, 17.5 mg x 2 weeks), then 20 mg for 18 weeks with 40 mg ADA SC injection EOW for 26 weeks
867630|NCT01185301|E3|Reported Event|ADA + 10 mg MTX|10 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867631|NCT01185301|E2|Reported Event|ADA + 5 mg MTX|5 mg MTX oral capsule weekly with 40 mg ADA SC injection EOW for 26 weeks
867634|NCT01185288|B2|Baseline|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867635|NCT01185288|B1|Baseline|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867636|NCT01185288|P2|Participant Flow|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867637|NCT01185288|P1|Participant Flow|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867638|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867639|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867640|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867641|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867642|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867643|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867644|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867645|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867646|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867647|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867648|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867649|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867650|NCT01185288|O2|Outcome|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867651|NCT01185288|O1|Outcome|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867652|NCT01185288|E2|Reported Event|Adalimumab + High Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, high dose methotrexate (20 mg orally once weekly).
867653|NCT01185288|E1|Reported Event|Adalimumab + Low Dose Methotrexate|Open-label adalimumab (40 mg subcutaneous every other week) plus blinded, low dose methotrexate (7.5 mg orally once weekly).
867654|NCT01185249|B1|Baseline|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
867655|NCT01185249|P1|Participant Flow|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
867656|NCT01185249|O2|Outcome|Morning Weight|Weight of study patients in kilograms first thing in the morning.
867657|NCT01185249|O1|Outcome|Evening Weights|Patients with both morning and evening weights
867658|NCT01185249|E1|Reported Event|Body Weight Taken in a Standing Position|Subjects will be weighed in the early morning, as standard of care dictates. They will also be weighed after evening medications are given, around 9pm. The evening weight is not standard, therefore considered the study intervention.
867659|NCT01185080|B4|Baseline|Total|Total of all reporting groups
867660|NCT01185080|B3|Baseline|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867661|NCT01185080|B2|Baseline|Placebo|Placebo three times weekly
867662|NCT01185080|B1|Baseline|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867663|NCT01185080|P3|Participant Flow|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867664|NCT01185080|P2|Participant Flow|Placebo|Placebo three times weekly
867665|NCT01185080|P1|Participant Flow|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867666|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867667|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867668|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867669|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867670|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867671|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867672|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867673|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867674|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867675|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867676|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867677|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867678|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867679|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867680|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867695|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867696|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867697|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867698|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867699|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867700|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867701|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867702|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867703|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867704|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867705|NCT01185080|O3|Outcome|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867706|NCT01185080|O2|Outcome|Placebo|Placebo three times weekly
867707|NCT01185080|O1|Outcome|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867708|NCT01185080|E3|Reported Event|AZD8848 60 μg|60 μg AZD8848 once weekly and placebo twice weekly
867709|NCT01185080|E2|Reported Event|Placebo|Placebo three times weekly
867710|NCT01185080|E1|Reported Event|AZD8848 20 μg x3|20 μg AZD8848 three times weekly
867711|NCT01185028|B1|Baseline|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
867712|NCT01185028|P1|Participant Flow|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
867713|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
867714|NCT01185028|O1|Outcome|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
867715|NCT01185028|E1|Reported Event|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
867716|NCT01184989|B1|Baseline|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
867717|NCT01184989|P1|Participant Flow|Patients Treated With Dabigatran Etexilate|"Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.~142 patients were enrolled for the study, but only 112 were treated. Therefore, the number of started patients corresponds to the ones that were actually treated."
867718|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
867719|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
867720|NCT01184989|O1|Outcome|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
867721|NCT01184989|E1|Reported Event|Patients Treated With Dabigatran Etexilate|Patients treated with Dabigatran Etexilate 150mg once daily. At the day of surgery the treatment will be initiated 1-4 h post surgery with 75mg.
867722|NCT01184898|B1|Baseline|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
867723|NCT01184898|P1|Participant Flow|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
867724|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
867725|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
867726|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
867727|NCT01184898|O1|Outcome|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
867728|NCT01184898|E1|Reported Event|Sirolimus and MEC|"Sirolimus and MEC (Mitoxantrone, Etoposide, and Cytarabine)~Sirolimus: Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.~MEC (Mitoxantrone, Etoposide, and Cytarabine): MEC (Mitoxantrone 8mg/m2/day IV, Etoposide 100mg/m2/day IV and Cytarabine 1000mg/ m2/day IV every 24 hours for 5 days) will be administered after sirolimus loading dose and 3 daily doses."
867775|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867729|NCT01184885|B1|Baseline|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
867730|NCT01184885|P1|Participant Flow|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
867731|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
867732|NCT01184885|O1|Outcome|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m^2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m^2 on day 6; Decadron 40mg/day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m^2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m^2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m^2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
867733|NCT01184885|E1|Reported Event|Hyper-CVAD and Sirolimus|"Hyper-CVAD and Sirolimus~Hyper-CVAD : - Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses.~Sirolimus : Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)"
867734|NCT01184872|B3|Baseline|Total|Total of all reporting groups
867735|NCT01184872|B2|Baseline|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867736|NCT01184872|B1|Baseline|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867737|NCT01184872|P2|Participant Flow|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867738|NCT01184872|P1|Participant Flow|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867739|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867740|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867741|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867742|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867776|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867777|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867743|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867744|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867745|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867746|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867747|NCT01184872|O2|Outcome|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867748|NCT01184872|O1|Outcome|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867749|NCT01184872|E2|Reported Event|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
867750|NCT01184872|E1|Reported Event|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
867751|NCT01184859|B6|Baseline|Total|Total of all reporting groups
867752|NCT01184859|B5|Baseline|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867753|NCT01184859|B4|Baseline|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867754|NCT01184859|B3|Baseline|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867755|NCT01184859|B2|Baseline|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867756|NCT01184859|B1|Baseline|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867757|NCT01184859|P5|Participant Flow|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867758|NCT01184859|P4|Participant Flow|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867759|NCT01184859|P3|Participant Flow|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867760|NCT01184859|P2|Participant Flow|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867761|NCT01184859|P1|Participant Flow|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867762|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867763|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867764|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867765|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867766|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867767|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867768|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867769|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867770|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867771|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867772|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867773|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867774|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867966|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867778|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867779|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867780|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867781|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867782|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867783|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867784|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867785|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867786|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867787|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867788|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867789|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867790|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867791|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867792|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867793|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867794|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867795|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867796|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867797|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867798|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867799|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867800|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867801|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867802|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867803|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867804|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867805|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867806|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867807|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867808|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867809|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867810|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867811|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867812|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867813|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867814|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867815|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867816|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867817|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867818|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867819|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867820|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867821|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867822|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867823|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867824|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867825|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867826|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867827|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867828|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867829|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867830|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867831|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867832|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867833|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867834|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867835|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867836|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867837|NCT01184859|O5|Outcome|Desmopressin 100µg|Study period 1: single dose of desmopressin 100µg. Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867838|NCT01184859|O4|Outcome|Desmopressin 50µg|Study period 1: single dose of desmopressin 50µg. Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867839|NCT01184859|O3|Outcome|Desmopressin 25µg|Study period 1: single dose of desmopressin 25µg. Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867840|NCT01184859|O2|Outcome|Desmopressin 10µg|Study period 1: single dose of desmopressin 10µg. Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867841|NCT01184859|O1|Outcome|Placebo|Study period 1: single dose of placebo. Study period 2: daily doses of placebo taken before bedtime for 28 days.
867842|NCT01184859|E10|Reported Event|Desmopressin 100µg - Period 2|Study period 2: daily doses of desmopressin 100µg taken before bedtime for 28 days.
867843|NCT01184859|E9|Reported Event|Desmopressin 50µg - Period 2|Study period 2: daily doses of desmopressin 50µg taken before bedtime for 28 days.
867844|NCT01184859|E8|Reported Event|Desmopressin 25µg - Period 2|Study period 2: daily doses of desmopressin 25µg taken before bedtime for 28 days.
867845|NCT01184859|E7|Reported Event|Desmopressin 10µg - Period 2|Study period 2: daily doses of desmopressin 10µg taken before bedtime for 28 days.
867846|NCT01184859|E6|Reported Event|Placebo - Period 2|Study period 2: daily doses of placebo taken before bedtime for 28 days.
867847|NCT01184859|E5|Reported Event|Desmopressin 100µg - Period 1|Study period 1: single dose of desmopressin 100µg.
867848|NCT01184859|E4|Reported Event|Desmopressin 50µg - Period 1|Study period 1: single dose of desmopressin 50µg.
867849|NCT01184859|E3|Reported Event|Desmopressin 25µg - Period 1|Study period 1: single dose of desmopressin 25µg.
867850|NCT01184859|E2|Reported Event|Desmopressin 10µg - Period 1|Study period 1: single dose of desmopressin 10µg.
867851|NCT01184859|E1|Reported Event|Placebo-Period 1|Study period 1: single dose of placebo.
867852|NCT01184846|B1|Baseline|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867853|NCT01184846|P1|Participant Flow|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867854|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867967|NCT01183858|E2|Reported Event|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867855|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867856|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867857|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867858|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867859|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867860|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867861|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867862|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867863|NCT01184846|O2|Outcome|IgPro10 - After Infusion|IgG levels were determined after infusion with IgPro10.
867864|NCT01184846|O1|Outcome|IgPro10 - Before Infusion|IgG levels were determined before infusion with IgPro10.
867865|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867866|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867867|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867868|NCT01184846|O1|Outcome|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867869|NCT01184846|E1|Reported Event|IgPro10|10% liquid formulation of human immunoglobulin (IgPro10). IgPro10 will be administered by IV infusion as one induction dose of 2 g/kg body weight (bw), followed by seven 3-weekly maintenance doses of 1 g/kg bw.
867870|NCT01184755|B4|Baseline|Total|Total of all reporting groups
867871|NCT01184755|B3|Baseline|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
867872|NCT01184755|B2|Baseline|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
867873|NCT01184755|B1|Baseline|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
867874|NCT01184755|P3|Participant Flow|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
867875|NCT01184755|P2|Participant Flow|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
867876|NCT01184755|P1|Participant Flow|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
867877|NCT01184755|O3|Outcome|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
867878|NCT01184755|O2|Outcome|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
867879|NCT01184755|O1|Outcome|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
867880|NCT01184755|E3|Reported Event|Usual Care|Participants continue their usual medication and other management for their hypertension. All participants (including UC) are given a home BP monitor and asked to take their BP in morning and evening 3 days/week.
867881|NCT01184755|E2|Reported Event|Relaxation Placebo Device|"Participants use modified device to pace breathing in the 13/minute range for daily practice for 8 weeks and no device thereafter~Relaxation: Participants are instructed to use the device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).~Sham RESPeRate"
867920|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
867882|NCT01184755|E1|Reported Event|Resperate Device Used for 8 Weeks|"Participants to use Resperate device to guide breathing for 8 weeks, then not used for next 8 weeks~Device-guided breathing: Participants instructed to practice daily for 15 minutes (guided and timed by the device used at home)~RESPeRate"
867883|NCT01184417|B3|Baseline|Total|Total of all reporting groups
867884|NCT01184417|B2|Baseline|Placebo Group|100 ml saline
867885|NCT01184417|B1|Baseline|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867886|NCT01184417|P2|Participant Flow|Placebo Group|100 ml saline
867887|NCT01184417|P1|Participant Flow|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867888|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867889|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867890|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867891|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867892|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867893|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867894|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867895|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867896|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867897|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867898|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867899|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867900|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867901|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867902|NCT01184417|O2|Outcome|Placebo Group|100 ml saline
867903|NCT01184417|O1|Outcome|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867904|NCT01184417|E2|Reported Event|Placebo Group|100 ml saline
867905|NCT01184417|E1|Reported Event|Phenobarbital Group|10 mg/kg IV phenobarbital in 100 ml saline
867906|NCT01184118|B1|Baseline|FP 220 mcg 2 Puffs BID|"The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.~FP 220 mcg 2 puffs BID: The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care."
867907|NCT01184118|P1|Participant Flow|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by 2 weeks of FP 220 mcg 2 puffs BID then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks.
867908|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
867909|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
867910|NCT01184118|O1|Outcome|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
867911|NCT01184118|E1|Reported Event|FP 220 mcg 2 Puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
867912|NCT01184079|B3|Baseline|Total|Total of all reporting groups
867913|NCT01184079|B2|Baseline|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
867914|NCT01184079|B1|Baseline|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
867915|NCT01184079|P2|Participant Flow|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
867916|NCT01184079|P1|Participant Flow|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
867917|NCT01184079|O2|Outcome|Group With Administration of 3rd Dose at 6 Months|"Group with administration of 3rd dose at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
867918|NCT01184079|O1|Outcome|Group With Administration of 3rd Dose at 12 Months|"Group with administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
867919|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
892100|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
867921|NCT01184079|O2|Outcome|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
867922|NCT01184079|O1|Outcome|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
867923|NCT01184079|E2|Reported Event|6 Month Administration|"3rd dose administration at 6 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months"
867924|NCT01184079|E1|Reported Event|12 Month Administration|"Administration of 3rd dose at 12 months~quadrivalent human papillomavirus vaccine : 0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months"
867925|NCT01184053|B1|Baseline|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
867926|NCT01184053|P1|Participant Flow|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
867927|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
867928|NCT01184053|O1|Outcome|Trisenox Treatment|"Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.~Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks."
867929|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
867930|NCT01184053|O1|Outcome|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
867931|NCT01184053|E1|Reported Event|Trisenox Treatment|Arsenic trioxide: Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
867932|NCT01184014|B3|Baseline|Total|Total of all reporting groups
867933|NCT01184014|B2|Baseline|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
867934|NCT01184014|B1|Baseline|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
867935|NCT01184014|P2|Participant Flow|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
867936|NCT01184014|P1|Participant Flow|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
867937|NCT01184014|O2|Outcome|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
867938|NCT01184014|O1|Outcome|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
867939|NCT01184014|E2|Reported Event|Control Group|the standard recommended care (Methodist Hospital Complete Insulin Orders)
867940|NCT01184014|E1|Reported Event|Experimental Group|a study-specific steroid NPH dosing algorithm plus standard recommended care
867941|NCT01183975|B1|Baseline|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
867942|NCT01183975|P1|Participant Flow|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
867943|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
867944|NCT01183975|O1|Outcome|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
867945|NCT01183975|E1|Reported Event|Patients Treated With SAGB by Solicited Teams|Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
867946|NCT01183858|B3|Baseline|Total|Total of all reporting groups
867947|NCT01183858|B2|Baseline|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867948|NCT01183858|B1|Baseline|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867949|NCT01183858|P2|Participant Flow|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867950|NCT01183858|P1|Participant Flow|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867951|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867952|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867953|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867954|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867955|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867956|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867957|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867958|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867959|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867960|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867961|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867962|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867963|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867964|NCT01183858|O1|Outcome|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867965|NCT01183858|O2|Outcome|Erlotinib 300 mg|Erlotinib 300 mg single daily oral dose until disease progression.
867968|NCT01183858|E1|Reported Event|Erlotinib 150 mg|Erlotinib 150 mg single daily oral dose until disease progression.
867969|NCT01183780|B3|Baseline|Total|Total of all reporting groups
867970|NCT01183780|B2|Baseline|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867971|NCT01183780|B1|Baseline|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867972|NCT01183780|P2|Participant Flow|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867973|NCT01183780|P1|Participant Flow|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil (FOLFIRI). Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 milligrams/kilogram (mg/kg) administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867974|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867975|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867976|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867977|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867978|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867979|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867980|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867981|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867982|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867983|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867984|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867985|NCT01183780|O2|Outcome|Placebo + FOLFIRI|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867986|NCT01183780|O1|Outcome|Ramucirumab + FOLFIRI|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867987|NCT01183780|E2|Reported Event|FOLFIRI + Placebo|"On Day 1 of each 14-day cycle, participants received placebo followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo: Administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867988|NCT01183780|E1|Reported Event|FOLFIRI + Ramucirumab|"On Day 1 of each 14-day cycle, participants received ramucirumab followed by other study treatment in the following sequence: Irinotecan, Folinic Acid and 5-Fluorouracil. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab: 8 mg/kg administered intravenously.~Irinotecan: 180 mg/m^2 administered intravenously.~Folinic Acid: 400 mg/m^2 administered intravenously.~5-Fluorouracil: 400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion."
867989|NCT01183728|B1|Baseline|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
867990|NCT01183728|P1|Participant Flow|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
867991|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
867992|NCT01183728|O1|Outcome|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
867993|NCT01183728|E1|Reported Event|MSV Autologous Transplantation|"Bone marrow collected from patient will be used for mesenchymal stem cells isolation and expansion under GMP conditions at IBGM-Valladolid (MSV). Autologous MSV implanted in knee by articular injection~Autologous bone marrow mesenchymal stem cells (MSV): Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection."
867994|NCT01183650|B3|Baseline|Total|Total of all reporting groups
867995|NCT01183650|B2|Baseline|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
867996|NCT01183650|B1|Baseline|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
867997|NCT01183650|P2|Participant Flow|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
867998|NCT01183650|P1|Participant Flow|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
867999|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
868000|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
868001|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
868002|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
868003|NCT01183650|O2|Outcome|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
868004|NCT01183650|O1|Outcome|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
868879|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868005|NCT01183650|E2|Reported Event|Caucasian Participants|Caucasian participants who received 5 mg of tadalafil once daily for 10 days
868006|NCT01183650|E1|Reported Event|Japanese Participants|Japanese participants who received 5 mg of tadalafil once daily for 10 days
868007|NCT01183546|B1|Baseline|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
868008|NCT01183546|P1|Participant Flow|Wheelchair Users With Spinal Cord Injury|wheelchair users with spinal cord injury
868009|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
868010|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
868011|NCT01183546|O2|Outcome|Followup Transfer Testing|Wheelchair users with spinal cord injury who met the criteria for transfer training at Baseline and returned four weeks later for transfer training and retesting.
868012|NCT01183546|O1|Outcome|Baseline Transfer Testing|Wheelchair Users with Spinal Cord Injury who met criteria for transfer training
868013|NCT01183546|E1|Reported Event|Wheelchair Users With ASIA A or B Spinal Cord Injury|wheelchair users with ASIA A or B spinal cord injury
868014|NCT01183533|B1|Baseline|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
868015|NCT01183533|P1|Participant Flow|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
868016|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
868017|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
868018|NCT01183533|O1|Outcome|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
868019|NCT01183533|E1|Reported Event|Off Label Rt-PA|"Off label rt-PA used on all subjects enrolled within 3 hours of waking with stroke symptoms at the standard of care dose.~Alteplase (iv t-PA): 0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour."
868020|NCT01183481|B1|Baseline|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
868021|NCT01183481|P1|Participant Flow|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
868022|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
868023|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
868024|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
868025|NCT01183481|O1|Outcome|Aprepitant and Granisetron|"Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the Palliative radiation therapy.~Aprepitant: Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.~Palliative radiation therapy: Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.~Granisetron: Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT)."
868137|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868026|NCT01183481|O1|Outcome|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
868027|NCT01183481|E1|Reported Event|Aprepitant and Granisetron|Patients will be given a single dose of Granisetron 2 mg orally and Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
868028|NCT01183468|B5|Baseline|Total|Total of all reporting groups
868029|NCT01183468|B4|Baseline|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
868030|NCT01183468|B3|Baseline|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
868031|NCT01183468|B2|Baseline|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868032|NCT01183468|B1|Baseline|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868033|NCT01183468|P4|Participant Flow|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
868034|NCT01183468|P3|Participant Flow|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
868035|NCT01183468|P2|Participant Flow|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868036|NCT01183468|P1|Participant Flow|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868037|NCT01183468|O4|Outcome|Part 1b (Aralast NP)-Subjects 8-17 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
868038|NCT01183468|O3|Outcome|Part 1b (Aralast NP)-Subjects Aged 18-35 Yrs|"Aralast NP 90 mg/kg/wk by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants undergo a minimum 3-wk washout period than then, each participant proceeds to high dose Aralast NP 180 mg/kg/wk by IV infusion for the next 6 weeks, for a total of 12 infusions.~Aralast NP 90 mg dose: - 90 mg/kg/week~Aralast NP 180 mg dose: - 180 mg/kg/week"
868039|NCT01183468|O2|Outcome|Part 1a (Aralast NP)-Subjects 8-15 Yrs|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868040|NCT01183468|O1|Outcome|Part 1a(Aralast NP)-Subjects Aged 16-35 Yrs|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by intravenous (IV) infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868041|NCT01183468|E2|Reported Event|Subjects Aged 8 – 15 Years|Subjects aged 8-15 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868042|NCT01183468|E1|Reported Event|Subjects Aged 16 – 35 Years|Subjects aged 16-35 years at enrollment with new-onset type 1 diabetes mellitus (T1DM) received Aralast NP 45 mg/kg by IV infusion once a week for 6 weeks. Following the Week 6 infusion, participants underwent a minimum 3-week washout period. After the washout period, each participant proceeded to a high dose of Aralast NP 90 mg/kg by IV infusion for the next 6 weeks, for a total of 12 infusions.
868043|NCT01183390|B3|Baseline|Total|Total of all reporting groups
868044|NCT01183390|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
868138|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868045|NCT01183390|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
868046|NCT01183390|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
868047|NCT01183390|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
868048|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
868049|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
868050|NCT01183390|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
868051|NCT01183390|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
868052|NCT01183390|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
868053|NCT01183390|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period
868054|NCT01183312|B3|Baseline|Total|Total of all reporting groups
868055|NCT01183312|B2|Baseline|Flumazenil First, Then Placebo|Sublingual flumazenil during the first intervention day and placebo during the second intervention day (after washout period).
868056|NCT01183312|B1|Baseline|Placebo First, Then Flumazenil|Placebo during the first intervention day and sublingual flumazenil during the second intervention day (after washout period).
868057|NCT01183312|P2|Participant Flow|Flumazenil First, Then Placebo|Flumazenil administered sublingually three times during the first study day (as 12 mg, then 6 mg, then 6 mg, at approximately 3 hour intervals), followed by a washout of at least 7 days, then placebo administered sublingually three times on the second study day.
868058|NCT01183312|P1|Participant Flow|Placebo First, Then Flumazenil|Placebo administered sublingually three times during the first study day, followed by a washout of at least 7 days, then flumazenil administered sublingually three times during the second study day.
868059|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
868060|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
868061|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
868062|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
868063|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
868064|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
868065|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
868066|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
868067|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
868068|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
868069|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
868070|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
868071|NCT01183312|O2|Outcome|Sublingual Flumazenil|Sublingual flumazenil administered three times over a single day (12 mg, 6 mg, 6 mg dosing), in either the first or second intervention period
868072|NCT01183312|O1|Outcome|Placebo|Sublingual placebo administered three times over a single day, in either first or second intervention period
868073|NCT01183312|E2|Reported Event|Sublingual Flumazenil|
868074|NCT01183312|E1|Reported Event|Placebo|
868075|NCT01183234|B3|Baseline|Total|Total of all reporting groups
868076|NCT01183234|B2|Baseline|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules)
868077|NCT01183234|B1|Baseline|Equasym XL First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (SPD544, Methylphenidate HCl given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
868078|NCT01183234|P2|Participant Flow|Metadate CD First, Then Equasym XL|Subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules)
868079|NCT01183234|P1|Participant Flow|Equasym XL (SPD544) First, Then Metadate CD|Subjects received a single oral dose of 60 mg of Equasym XL (given as two 30 mg capsules), then a 7-day washout period, then subjects received a single oral dose of 60 mg of Metadate CD (given as one 60 mg capsule)
868080|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
868081|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
868082|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
868083|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
868084|NCT01183234|O2|Outcome|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
868085|NCT01183234|O1|Outcome|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
868086|NCT01183234|E2|Reported Event|Metadate CD|Subjects received a single oral dose of 60 mg of Metadate CD (Methylphenidate HCl given as one 60 mg capsule)
868087|NCT01183234|E1|Reported Event|Equasym XL|Subjects received a single oral dose of 60 mg of Equasym XL (Methylphenidate HCl given as two 30 mg capsules)
868088|NCT01183169|B5|Baseline|Total|Total of all reporting groups
868089|NCT01183169|B4|Baseline|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868090|NCT01183169|B3|Baseline|Treatment C|Treatment C1 + Treatment C2. ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868091|NCT01183169|B2|Baseline|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868092|NCT01183169|B1|Baseline|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868093|NCT01183169|P7|Participant Flow|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868094|NCT01183169|P6|Participant Flow|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868095|NCT01183169|P5|Participant Flow|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868096|NCT01183169|P4|Participant Flow|Treatment C2|Treatment C subset C2: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV 400 mg twice daily (BID) with PEG and RBV.
868097|NCT01183169|P3|Participant Flow|Treatment C1|Treatment C subset C1: ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving complete early virologic response (cEVR: hepatitis C virus (HCV) ribonucleic acid (RNA) <LOQ after 12 weeks of treatment) could switch to active ALV 600 mg QD with PEG and RBV.
868098|NCT01183169|P2|Participant Flow|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868099|NCT01183169|P1|Participant Flow|Treatment A|Alisporivir (ALV; DEB025) 600 mg once daily (QD) with peginterferon alfa-2a (PEG) and ribavirin (RBV) for up to 48 weeks.
868100|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868101|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868102|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868103|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868104|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868105|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868106|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868107|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868108|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868109|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868110|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868111|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868112|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868113|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868114|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868115|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868116|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868117|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868118|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868119|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868120|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868121|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868122|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868123|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868124|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868125|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868126|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868127|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868128|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868129|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868130|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868131|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868132|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868133|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868134|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868135|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868136|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868139|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868140|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868141|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868142|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868143|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868144|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868145|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868146|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868147|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868148|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868149|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868150|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868151|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868152|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868153|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868154|NCT01183169|O6|Outcome|Treatment C2A|ALV 400 mg BID with PEG and RBV in participants not achieving cEVR in Treatment C subset C2.
868155|NCT01183169|O5|Outcome|Treatment C1A|ALV 600 mg QD with PEG and RBV in participants not achieving cEVR in Treatment C subset C1.
868156|NCT01183169|O4|Outcome|Treatment D|ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868157|NCT01183169|O3|Outcome|Treatment C|ALV placebo with PEG and RBV for up to 48 weeks; participants not achieving cEVR could switch to active ALV.
868158|NCT01183169|O2|Outcome|Treatment B|ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868159|NCT01183169|O1|Outcome|Treatment A|ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868160|NCT01183169|E10|Reported Event|Treatment D: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868161|NCT01183169|E9|Reported Event|Treatment C2: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
868162|NCT01183169|E8|Reported Event|Treatment C1: Post-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
868163|NCT01183169|E7|Reported Event|Treatment B: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868164|NCT01183169|E6|Reported Event|Treatment A: Post-treatment AEs|AEs occurring after end of treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868165|NCT01183169|E5|Reported Event|Treatment D: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 400 mg BID with PEG and RBV for up to 48 weeks.
868166|NCT01183169|E4|Reported Event|Treatment C2: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 400 mg BID post-switch) with PEG and RBV for up to 48 weeks.
868167|NCT01183169|E3|Reported Event|Treatment C1: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV placebo (and may have received ALV 600 mg QD post-switch) with PEG and RBV for up to 48 weeks.
868168|NCT01183169|E2|Reported Event|Treatment B: On-treatment AEs|AEs occurring while on treatment in participants receiving ALV 800 mg QD with PEG and RBV for up to 48 weeks.
868169|NCT01183169|E1|Reported Event|Treatment A: On-treatment AEs|Adverse events (AEs) occurring while on treatment in participants receiving ALV 600 mg QD with PEG and RBV for up to 48 weeks.
868170|NCT01183104|B3|Baseline|Total|Total of all reporting groups
868171|NCT01183104|B2|Baseline|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868172|NCT01183104|B1|Baseline|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868173|NCT01183104|P2|Participant Flow|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868174|NCT01183104|P1|Participant Flow|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
868175|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868176|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868177|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868178|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868179|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868180|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868181|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868182|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868183|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868184|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868185|NCT01183104|O2|Outcome|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868186|NCT01183104|O1|Outcome|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868187|NCT01183104|E2|Reported Event|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
868188|NCT01183104|E1|Reported Event|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; eGFR 30=< <50).
868189|NCT01183065|B1|Baseline|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
868190|NCT01183065|P1|Participant Flow|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
868191|NCT01183065|O1|Outcome|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
868192|NCT01183065|E1|Reported Event|Pralatrexate and Vitamin Supplementation|"This will be an open-label, single arm, Simon optimal two-stage design phase II study.~Pralatrexate With Vitamin B12 and Folic Acid: Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate."
868193|NCT01183013|B8|Baseline|Total|Total of all reporting groups
868194|NCT01183013|B7|Baseline|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
868195|NCT01183013|B6|Baseline|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
868196|NCT01183013|B5|Baseline|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by a blinded trial period on linagliptin 5mg + pioglitazone 30mg FDC
868197|NCT01183013|B4|Baseline|Lina5/Lina5|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
868198|NCT01183013|B3|Baseline|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
868199|NCT01183013|B2|Baseline|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
868200|NCT01183013|B1|Baseline|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
868201|NCT01183013|P7|Participant Flow|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
868202|NCT01183013|P6|Participant Flow|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
868203|NCT01183013|P5|Participant Flow|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
868204|NCT01183013|P4|Participant Flow|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
868205|NCT01183013|P3|Participant Flow|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
868206|NCT01183013|P2|Participant Flow|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
868207|NCT01183013|P1|Participant Flow|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
868208|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868209|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868210|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868211|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868212|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868213|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868214|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868215|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868216|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868217|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868218|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868219|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868220|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868221|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868222|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868223|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868224|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868225|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868226|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868227|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868228|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868229|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868230|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868231|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868232|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868233|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868234|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868235|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868236|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868237|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868238|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868239|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868240|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868241|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868242|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868243|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868244|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868245|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868246|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868247|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868248|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868249|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868250|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868251|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868252|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868253|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868254|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868255|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868931|NCT01181050|B3|Baseline|Total|Total of all reporting groups
868256|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868257|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868258|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868259|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868260|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868261|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
868262|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868263|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868264|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868265|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868266|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868267|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868268|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks
868269|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868270|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868271|NCT01183013|O7|Outcome|Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 6 weeks and were titrated to linagliptin 5mg + pioglitazone 45mg for the next 24 weeks.
868272|NCT01183013|O6|Outcome|Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for the first 30 weeks
868273|NCT01183013|O5|Outcome|Lina5Pio15|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for the first 30 weeks
868274|NCT01183013|O4|Outcome|Lina5|Participants treated with linagliptin 5mg once daily for the first 30 weeks
868275|NCT01183013|O3|Outcome|Pio45|Participants treated with pioglitazone 30mg monotherapy for 6 weeks and were titrated to pioglitazone 45mg monotherapy for the next 24 weeks.
868276|NCT01183013|O2|Outcome|Pio30|Participants treated with pioglitazone 30mg monotherapy for the first 30 weeks
868277|NCT01183013|O1|Outcome|Pio15|Participants treated with pioglitazone 15mg monotherapy for the first 30 weeks
868278|NCT01183013|E7|Reported Event|Lina5Pio45/Lina5Pio45|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 6 weeks and linagliptin 5mg + pioglitazone 45mg FDC for 24 weeks followed by linagliptin 5mg + pioglitazone 45mg FDC for up to 54 weeks.
868279|NCT01183013|E6|Reported Event|Lina5Pio30/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 30mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
868280|NCT01183013|E5|Reported Event|Lina5Pio15/Lina5Pio30|Participants treated with linagliptin 5mg + pioglitazone 15mg fixed dose combination (FDC) for 30 weeks followed by linagliptin 5mg + pioglitazone 30mg FDC for up to 54 weeks.
868281|NCT01183013|E4|Reported Event|Lina5/Lina5|Participants treated with linagliptin 5mg once daily for 30 weeks followed by linagliptin 5mg once daily for up to 54 weeks.
868282|NCT01183013|E3|Reported Event|Pio45/Pio45|Participants treated with pioglitazone 30 mg for 6 weeks and then were titrated up to pioglitazone 45mg for 24 weeks followed by pioglitazone 45mg for up to 54 weeks.
868283|NCT01183013|E2|Reported Event|Pio30/Pio30|Participants treated with pioglitazone 30mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
868284|NCT01183013|E1|Reported Event|Pio15/Pio30|Participants treated with pioglitazone 15mg for 30 weeks followed by pioglitazone 30mg for up to 54 weeks.
868285|NCT01182805|B1|Baseline|Single Arm Study.|
868286|NCT01182805|P1|Participant Flow|All Study Participants|All study participants underwent measurement of Diastolic Circumferential Strain Rate during Isovolumic Relaxation as well as measurement of E-prime by tissue Doppler. They also all had evaluation of their diastolic function by the combination of their mitral inflow pattern and invasive measure of left ventricular end-diastolic pressure.
868287|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
868288|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
868289|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
868290|NCT01182805|O3|Outcome|Grade 2 Diastolic Dysfunction|These were the subjects deemed to have Grade 2 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP > 15 mm Hg).
868291|NCT01182805|O2|Outcome|Grade 1 Diastolic Dysfunction|These were the subjects deemed to have Grade 1 diastolic dysfunction using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A < 1.0).
868292|NCT01182805|O1|Outcome|Normal Diastolic Function|These were the subjects deemed to have normal diastolic function using the gold standard assessment of mitral inflow and LV end-diastolic pressure (E/A 1 - 2 and LVEDP <= 15 mm Hg).
868293|NCT01182805|E1|Reported Event|Single Arm Study.|
868311|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
892101|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
868294|NCT01182727|B1|Baseline|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
868295|NCT01182727|P1|Participant Flow|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
868296|NCT01182727|O1|Outcome|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
868297|NCT01182727|E1|Reported Event|Salsalate|Salsalate will be administered in two divided doses of 2grams in the morning and 2 grams in the evening. Salsalate will be administered for 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until a tolerated dose or a minimum dose of 2 grams per day is reached.
868298|NCT01182675|B3|Baseline|Total|Total of all reporting groups
868299|NCT01182675|B2|Baseline|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
868300|NCT01182675|B1|Baseline|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
868301|NCT01182675|P2|Participant Flow|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
868302|NCT01182675|P1|Participant Flow|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
868303|NCT01182675|O2|Outcome|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
868304|NCT01182675|O1|Outcome|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
868305|NCT01182675|E2|Reported Event|T-cell Graft Resistant SCID|"Patients with SCID with NK+ phenotype with HLA-mismatched donor~Transplant Conditioning with Mobilization and Alemtuzumab: Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant"
868306|NCT01182675|E1|Reported Event|T-cell Graft Permissive SCID|"Patients with SCID with:~i. NK- phenotype; ii. NK+ phenotype with 10/10 HLA-matched relative or unrelated donor; or iii. NK+ phenotype with maternal engraftment by STR analysis and undergoing haplocompatible HSCT from maternal donor~Transplant Conditioning with Mobilization Only: Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant"
868307|NCT01182610|B1|Baseline|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36~Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
868308|NCT01182610|P1|Participant Flow|Treatment Group|"Treatment group : Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
868309|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
868310|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
868312|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
868313|NCT01182610|O1|Outcome|Treatment Group|"Panitumumab 9mg/kg on Days 1, 22, and 43~Paclitaxel 200mg/m2 on Days 1 and 22~Carboplatin AUC=6 on Days 1 and 22~5FU 225mg/m2/day on Days 1-15 and 22-36"
868314|NCT01182610|E1|Reported Event|Treatment Group: Panitumumab, Paclitaxel, Carboplatin and 5FU|Panitumumab 9mg/kg on Days 1, 22, and 43; Paclitaxel 200mg/m2 on Days 1 and 22; Carboplatin AUC=6 on Days 1 and 22; 5FU 225mg/m2/day on Days 1-15 and 22-36
868315|NCT01182493|B3|Baseline|Total|Total of all reporting groups
868316|NCT01182493|B2|Baseline|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
868317|NCT01182493|B1|Baseline|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient"
868318|NCT01182493|P2|Participant Flow|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
868319|NCT01182493|P1|Participant Flow|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
868320|NCT01182493|O2|Outcome|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
868321|NCT01182493|O1|Outcome|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
868322|NCT01182493|E2|Reported Event|Insulin Treatment With MDI|patients treated with Multiple Daily Injections (MDI); basal/bolus therapy with rapid- and long-acting analogs with at least 3 injections per day
868323|NCT01182493|E1|Reported Event|Insulin Pump Treatment|"Patients will get an insulin pump~Insulin Pump (Medtronic Minimed Paradigm® VEO): The pump delivers insulin as specified by the patient."
868324|NCT01182480|B1|Baseline|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
868325|NCT01182480|P1|Participant Flow|Text Intervention|Group of study participants who received the text message intervention over a 3-month period. Participants received text messages 7, 2, and 1 day(s) prior to each of their scheduled appointments as recorded in the Denver Health scheduling system, and also received text messages prompts 3 times per week asking them to provide fasting blood sugar readings.
868326|NCT01182480|O1|Outcome|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
868327|NCT01182480|E1|Reported Event|Text Intervention|Group of study participants who received the text message intervention over a 3-month period.
868328|NCT01182428|B3|Baseline|Total|Total of all reporting groups
868329|NCT01182428|B2|Baseline|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868330|NCT01182428|B1|Baseline|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868331|NCT01182428|P2|Participant Flow|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868332|NCT01182428|P1|Participant Flow|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868333|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868334|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868335|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868336|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868337|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868338|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868339|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868340|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868341|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868342|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868343|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868344|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868345|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868346|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868347|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868348|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868349|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868350|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868351|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868352|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868353|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868354|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868355|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868356|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868357|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868358|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868359|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868360|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868361|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868362|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868363|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868364|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868365|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868366|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868367|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868368|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868369|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868370|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868371|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868372|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868373|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868374|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868375|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868376|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868377|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868378|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868379|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868380|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868381|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868382|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868383|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868384|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868385|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868386|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868387|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868388|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868389|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868390|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868391|NCT01182428|O2|Outcome|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868392|NCT01182428|O1|Outcome|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868393|NCT01182428|E2|Reported Event|CYPHER® SELECT|Subjects Randomized to CYPHER® SELECT. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868394|NCT01182428|E1|Reported Event|XIENCE V® / XIENCE PRIME®|Subjects Randomized to XIENCE V®/XIENCE PRIME®. The number of participants at risk excludes subjects who are lost to follow up through 1 year without any event.
868395|NCT01182376|B3|Baseline|Total|Total of all reporting groups
868396|NCT01182376|B2|Baseline|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868397|NCT01182376|B1|Baseline|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868398|NCT01182376|P2|Participant Flow|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868399|NCT01182376|P1|Participant Flow|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868400|NCT01182376|O2|Outcome|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868401|NCT01182376|O1|Outcome|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868402|NCT01182376|E2|Reported Event|Multaq® (Dronedarone)|"Half of the patients will be prescribed dronedarone.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868403|NCT01182376|E1|Reported Event|Placebo|"Half of the patients will be assigned placebo.~dronedarone: Dronedarone will be prescribed by the patient's team according to established guidelines."
868404|NCT01182337|B3|Baseline|Total|Total of all reporting groups
868405|NCT01182337|B2|Baseline|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868406|NCT01182337|B1|Baseline|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868407|NCT01182337|P2|Participant Flow|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868408|NCT01182337|P1|Participant Flow|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868409|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868410|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868411|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868625|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868412|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868413|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868414|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868415|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868416|NCT01182337|O1|Outcome|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868417|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868418|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868419|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868420|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868421|NCT01182337|O2|Outcome|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868422|NCT01182337|O1|Outcome|Intradiscal rhGDF-5 1.0mg|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868423|NCT01182337|E2|Reported Event|Vehicle Control|"Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection"
868424|NCT01182337|E1|Reported Event|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
868425|NCT01182298|B1|Baseline|Standard|HCV INFECTED LATINO ARTICIPANTS
868426|NCT01182298|P1|Participant Flow|PegIFN and Ribavirin|"Latino Patients with hepatitis C receiving weekly pegIFN and ribavirin.~This is an observational study. The observed treatment is received and managed through their primary care."
868427|NCT01182298|O1|Outcome|Hepatitis C|latino participants with Hepatitis C
868428|NCT01182298|E1|Reported Event|Standard|Patients receiving weekly peg interferon and ribavirin for hCV treatment were studied This is an observational study. The observed treatment is received and managed through their primary care.
868429|NCT01182285|B1|Baseline|All Participants (Phase 1 and Phase 2 Schedule 2)|"A- Phase 1 Radioiodine-Resistant Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening~B2 - Phase 2 Schedule 2 Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks."
868430|NCT01182285|P3|Participant Flow|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
868431|NCT01182285|P2|Participant Flow|B1 - Phase 2 Schedule 1 (Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 17 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Drug: Cytomel (25 micrograms) Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Liothyronine Sodium (Cytomel) for 4 weeks (25 micrograms twice a day)
868432|NCT01182285|P1|Participant Flow|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
868626|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868433|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
868434|NCT01182285|O1|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radiiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
868435|NCT01182285|O1|Outcome|All Participants|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
868436|NCT01182285|O2|Outcome|B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake)|Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
868437|NCT01182285|O1|Outcome|A - Phase 1 Radioiodine Resistant Thyroid Cancer|Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening
868438|NCT01182285|E1|Reported Event|All Participants (Phase 1 and Phase 2 Schedule 2)|A - Phase 1 Radioiodine Resistant Thyroid Cancer Drug: Valproic Acid Week 1 - 10 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening B2 - Phase 2 Schedule 2 (No Increased Radioiodine Uptake) Drug: Valproic Acid Week 11 - 52 (Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening Weeks 17-52: Patients who show a response by RECIST criteria or have a decreased thyroglobulin level from Day 1 of the treatment (registered as a partial response to the treatment) will continue on valproic acid at their current dose for a total of 52 weeks.
868439|NCT01182207|B3|Baseline|Total|Total of all reporting groups
868440|NCT01182207|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
868441|NCT01182207|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
868442|NCT01182207|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
868443|NCT01182207|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
868444|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868445|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868446|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868447|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868448|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868449|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868450|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868451|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868452|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868453|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868454|NCT01182207|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868455|NCT01182207|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868456|NCT01182207|E2|Reported Event|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868457|NCT01182207|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868458|NCT01182194|B3|Baseline|Total|Total of all reporting groups
868459|NCT01182194|B2|Baseline|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
868460|NCT01182194|B1|Baseline|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
868627|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868461|NCT01182194|P2|Participant Flow|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
868462|NCT01182194|P1|Participant Flow|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
868463|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868464|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868465|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868466|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868467|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868468|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868469|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868470|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868471|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868472|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868473|NCT01182194|O2|Outcome|YAZ® (Reference)|3 mg/0.02 mg YAZ® Tablets reference product dosed in either period.
868474|NCT01182194|O1|Outcome|Drospirenone/Ethinyl Estradiol (Test)|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in either period.
868475|NCT01182194|E2|Reported Event|YAZ® (Reference) First|3 mg/0.02 mg YAZ® Tablets reference product dosed in first period followed by 3 mg/0.02 mg Drospirenone/Ethinyl Estradiol test product dosed in the second period.
868476|NCT01182194|E1|Reported Event|Drospirenone/Ethinyl Estradiol (Test) First|3 mg/0.02 mg Drospirenone/Ethinyl Estradiol Tablets test product dosed in first period followed by 3 mg/0.02 mg YAZ® Tablets reference product dosed in the second period.
868477|NCT01182181|B3|Baseline|Total|Total of all reporting groups
868478|NCT01182181|B2|Baseline|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
868479|NCT01182181|B1|Baseline|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
868480|NCT01182181|P2|Participant Flow|Arimidex® (Reference) First|1 mg Arimidex® Tablets reference product dosed in first period followed by 1 mg Anastrazole Tablets test product dosed in the second period.
868481|NCT01182181|P1|Participant Flow|Anastrazole (Test) First|1 mg Anastrozole Tablets test product dosed in first period followed by 1 mg Arimidex® Tablets reference product dosed in the second period.
868482|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
868483|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
868484|NCT01182181|O2|Outcome|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
868485|NCT01182181|O1|Outcome|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
868486|NCT01182181|E2|Reported Event|Arimidex® (Reference)|1 mg Arimidex® Tablets reference product dosed in either period.
868487|NCT01182181|E1|Reported Event|Anastrazole (Test)|1 mg Anastrozole Tablets test product dosed in either period.
868488|NCT01182103|B3|Baseline|Total|Total of all reporting groups
868489|NCT01182103|B2|Baseline|Healthy Subjects|
868490|NCT01182103|B1|Baseline|Major Depressive Patients|
868491|NCT01182103|P2|Participant Flow|Healthy Subjects|
868492|NCT01182103|P1|Participant Flow|Major Depressive Patients|
868493|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
868494|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
868495|NCT01182103|O1|Outcome|Healthy Subjects|
868496|NCT01182103|O3|Outcome|Major Depressive Patients After Treatment|
868497|NCT01182103|O2|Outcome|Major Depressive Patients Before Treatment|
868498|NCT01182103|O1|Outcome|Healthy Subjects|
868499|NCT01182103|O2|Outcome|Healthy Subjects|
868500|NCT01182103|O1|Outcome|Major Depressive Patients|
868501|NCT01182103|E2|Reported Event|Healthy Subjects|
868502|NCT01182103|E1|Reported Event|Major Depressive Patients|
868503|NCT01181986|B3|Baseline|Total|Total of all reporting groups
868504|NCT01181986|B2|Baseline|Sub-study 2: Exenatide IV|Intravenous infusion of (1) Saline+Exenatide, (2) Saline+Placebo or (3) Exendin-9+Exenatide on 3 seperate days, crossover study
868505|NCT01181986|B1|Baseline|Sub-study 1: Exenatide SC|Exenatide 5-10 ug or placebo sc BID/10 days, day 11 AM dose and meal test - crossover study
868506|NCT01181986|P3|Participant Flow|Exenatide IV (Sub-study 2)|Patients received in random order on single day an intravenous infusion of (1) Saline+Exenatide, (2) Exendin-9+Exenatide or (3) Saline+Placebo
868507|NCT01181986|P2|Participant Flow|Placebo Then Exenatide (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
868508|NCT01181986|P1|Participant Flow|Exenatide Then Placebo (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
868509|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
868510|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
868511|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Patients received placebo sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
868512|NCT01181986|O1|Outcome|Exenatide (Sub-study 1)|Patients received exenatide 5-10 ug sc BID for 10 days. On day 11, after receiving AM dose, vascular and blood parameters responses to study meal were tested.
868513|NCT01181986|O5|Outcome|Exendin-9+Exenatide (Sub-study 2)|Infusion of exendin-9 (min 0-75), added exenatide infusion (min 30-75)
868514|NCT01181986|O4|Outcome|Saline+Placebo (Sub-study 2)|Infusion of saline (min 0-75), added placebo infusion (min 30-75)
868515|NCT01181986|O3|Outcome|Saline+Exenatide (Sub-study 2)|Infusion of saline (min 0-75), added exenatide infusion (min 30-75)
868516|NCT01181986|O2|Outcome|Placebo (Sub-study 1)|Placebo sc BID for 10 days
868517|NCT01181986|O1|Outcome|Exenatide (Subs-study 1)|Exenatide: Exenatide 5-10 ug sc BID/10 days
868518|NCT01181986|E5|Reported Event|Exendin-9+Exenatide IV (Sub-study 2)|Intravenous infusion of exendin-9 (min 0-75), added intravenous infusion of placebo (min30-75)
868519|NCT01181986|E4|Reported Event|Saline+Placebo (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of placebo (min30-75)
868520|NCT01181986|E3|Reported Event|Saline+Exenatide IV (Sub-study 2)|Intravenous infusion of saline (min 0-75), added intravenous infusion of exenatide (min30-75)
868521|NCT01181986|E2|Reported Event|Placebo SC (Sub-study 1)|Placebo sc BID/10days, AM dose and meal test on day 11
868522|NCT01181986|E1|Reported Event|Exenatide SC (Sub-study 1)|Exenatide 5-10 ug sc BID/10 days, AM dose and meal test on day 11
868523|NCT01181947|B1|Baseline|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
868524|NCT01181947|P1|Participant Flow|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
868525|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection >~> TEVAR: Thoracic endovascular aneurysm repair"
868526|NCT01181947|O1|Outcome|Patients Undergoing TEVAR|"Those with a thoracic aortic aneurysm/dissection~TEVAR: Thoracic endovascular aneurysm repair"
868527|NCT01181947|E1|Reported Event|1. VCOUS|Medtronic VCOUS
868528|NCT01181921|B1|Baseline|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
868529|NCT01181921|P1|Participant Flow|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
868530|NCT01181921|O1|Outcome|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
868531|NCT01181921|E1|Reported Event|Galantamine|Galantamine (capsules/oral use). Starting dose: 8 mg/day for 4 weeks; initial maintenance dose: 16 mg/day for 4 weeks; then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
868532|NCT01181895|B4|Baseline|Total|Total of all reporting groups
868533|NCT01181895|B3|Baseline|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868534|NCT01181895|B2|Baseline|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868535|NCT01181895|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868536|NCT01181895|P3|Participant Flow|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868537|NCT01181895|P2|Participant Flow|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868538|NCT01181895|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868539|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868540|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868541|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868542|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868543|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868544|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868545|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868546|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868547|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868548|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868549|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868550|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868551|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868552|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868553|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868554|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868555|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868556|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868557|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868558|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868559|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868560|NCT01181895|O3|Outcome|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868628|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868561|NCT01181895|O2|Outcome|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868562|NCT01181895|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868563|NCT01181895|E3|Reported Event|Salmeterol 50 µg BID|Participants received Salmeterol 50 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868564|NCT01181895|E2|Reported Event|Vilanteral 25 µg OD|Participants received Vilanterol (VI) 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
868565|NCT01181895|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 12 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
868566|NCT01181804|B5|Baseline|Total|Total of all reporting groups
868567|NCT01181804|B4|Baseline|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
868568|NCT01181804|B3|Baseline|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
868569|NCT01181804|B2|Baseline|Boceprevir Capsules Then Tablets (Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
868570|NCT01181804|B1|Baseline|Boceprevir Tablets Then Capsules (Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
868571|NCT01181804|P4|Participant Flow|Boceprevir Capsules Then Tablets (Fasted)|Participants will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir tablets, orally, following and overnight fast.
868572|NCT01181804|P3|Participant Flow|Boceprevir Tablets Then Capsules (Fasted)|Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast and then 4 days later will receive a single dose of boceprevir capsules, orally, following and overnight fast.
868573|NCT01181804|P2|Participant Flow|Boceprevir Capsules Then Tablets ( Fed)|Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition.
868574|NCT01181804|P1|Participant Flow|Boceprevir Tablets Then Capsules ( Fed)|Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition.
868575|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868576|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868577|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868578|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868579|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868580|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868581|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868582|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868583|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868584|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868585|NCT01181804|O2|Outcome|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868586|NCT01181804|O1|Outcome|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
892102|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
868587|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868588|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868589|NCT01181804|O2|Outcome|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868590|NCT01181804|O1|Outcome|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868591|NCT01181804|E4|Reported Event|Boceprevir Capsules (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868592|NCT01181804|E3|Reported Event|Boceprevir Tablets (Fasted)|In Part 2 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 3 or Period 4 under fasted conditions.
868593|NCT01181804|E2|Reported Event|Boceprevir Capsules (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in capsule formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868594|NCT01181804|E1|Reported Event|Boceprevir Tablets (Fed)|In Part 1 of the study, participants received a single dose of boceprevir (800 mg) in tablet formulation in a cross-over manner during either Period 1 or Period 2 under fed conditions.
868595|NCT01181778|B1|Baseline|All Participants|All participants who were enrolled in the study
868596|NCT01181778|P1|Participant Flow|All Participants|All participants who were enrolled in the study
868597|NCT01181778|O1|Outcome|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
868598|NCT01181778|O2|Outcome|All Qualified Participants After Counseling|After counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
868599|NCT01181778|O1|Outcome|All Qualified Participants Before Counseling|Before counseling: All healthy women who were eligible for primary and secondary outcome measure analysis, based on the physician's assessment
868600|NCT01181778|E1|Reported Event|All Qualified Participants|All healthy women who consulted their physician for information on contraceptive choices and were eligible for primary and secondary outcome measure analysis and safety analysis, based on the physician's assessment
868601|NCT01181726|B3|Baseline|Total|Total of all reporting groups
868602|NCT01181726|B2|Baseline|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
868603|NCT01181726|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
868604|NCT01181726|P2|Participant Flow|Activella® (Reference) First|1 mg/0.5 mg Activella® Tablets reference product dosed in first period followed by 1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in the second period.
868605|NCT01181726|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in first period followed by 1 mg/0.5 mg Activella® Tablets reference product dosed in the second period.
868606|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868607|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868608|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868609|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868610|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868611|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868612|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868613|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868614|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868615|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868616|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868617|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868618|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868619|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868620|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868621|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868622|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868623|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868624|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
892103|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
868629|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868630|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868631|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868632|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868633|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868634|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868635|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868636|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868637|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868638|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868639|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868640|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868641|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868642|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868643|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868644|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868645|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868646|NCT01181726|O2|Outcome|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868647|NCT01181726|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868648|NCT01181726|E2|Reported Event|Activella® (Reference)|1 mg/0.5 mg Activella® Tablets reference product dosed in either period.
868649|NCT01181726|E1|Reported Event|Estradiol/Norethindrone Acetate (Test)|1 mg/0.5 mg Estradiol/Norethindrone Acetate Tablets test product dosed in either period.
868650|NCT01181609|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868651|NCT01181609|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 milligrams per kilogram (mg/kg) intravenously (IV) per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868652|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868653|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868654|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868655|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868656|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868657|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868658|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
892104|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
868659|NCT01181609|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868660|NCT01181609|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 2.5 mg/kg IV per week, either as 5 mg/kg on Day 1 of a 2-week cycle or as 7.5 mg/kg on Day 1 of a 3-week cycle and was dependent on the chemotherapy regimen used. The choice of chemotherapy regimen was left to the discretion of the investigator per standard of care at the study site. Cycle was repeated until disease progression or withdrawal of participant.
868661|NCT01181531|B3|Baseline|Total|Total of all reporting groups
868662|NCT01181531|B2|Baseline|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
868663|NCT01181531|B1|Baseline|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
868664|NCT01181531|P2|Participant Flow|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
868665|NCT01181531|P1|Participant Flow|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
868666|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
868667|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
868668|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
868669|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
868670|NCT01181531|O2|Outcome|Cinacalcet|Cinacalcet Hydrochloride
868671|NCT01181531|O1|Outcome|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
868672|NCT01181531|E2|Reported Event|Cinacalcet|Cinacalcet Hydrochloride (Sensipar)
868673|NCT01181531|E1|Reported Event|Traditional Vitamin D|Vitamin D sterol, intravenous (IV) or oral
868674|NCT01181492|B4|Baseline|Total|Total of all reporting groups
868675|NCT01181492|B3|Baseline|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
868676|NCT01181492|B2|Baseline|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
868677|NCT01181492|B1|Baseline|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
868678|NCT01181492|P3|Participant Flow|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
868679|NCT01181492|P2|Participant Flow|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
868680|NCT01181492|P1|Participant Flow|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
868681|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
868682|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
868683|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
868684|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
868685|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
868686|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
868687|NCT01181492|O3|Outcome|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
868688|NCT01181492|O2|Outcome|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
868689|NCT01181492|O1|Outcome|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
868690|NCT01181492|E3|Reported Event|*1G/*1G|Grouped by CYP3A4*1G polymorphism,*1G/*1G: mutant homozygote
868691|NCT01181492|E2|Reported Event|*1/*1G|Grouped by CYP3A4*1G polymorphism,*1/*1G: mutant heterozygote
868692|NCT01181492|E1|Reported Event|*1/*1|Grouped by CYP3A4*1G polymorphism, wild-type homozygote
868693|NCT01181349|B1|Baseline|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
868694|NCT01181349|P1|Participant Flow|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
868695|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
868696|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
868697|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
868698|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
868699|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
868700|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
868701|NCT01181349|O2|Outcome|P07535 Study Participants With a TOF Ratio ≥0.9|Participants with TOF ratio ≥0.9 upon arrival at PACU, defined as indicating absence of residual neuromuscular blockade
868702|NCT01181349|O1|Outcome|P07535 Study Participants With a TOF Ratio <0.9|Participants with TOF ratio <0.9 upon arrival at PACU, defined as indicating presence of residual neuromuscular blockade
868703|NCT01181349|O1|Outcome|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
868704|NCT01181349|E1|Reported Event|All Participants|"Adult study participants undergoing different types of elective surgical procedures requiring general anesthesia~with neuromuscular blocking agents"
868705|NCT01181323|B5|Baseline|Total|Total of all reporting groups
868706|NCT01181323|B4|Baseline|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868707|NCT01181323|B3|Baseline|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
892105|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
868708|NCT01181323|B2|Baseline|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868709|NCT01181323|B1|Baseline|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868710|NCT01181323|P4|Participant Flow|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868711|NCT01181323|P3|Participant Flow|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
868712|NCT01181323|P2|Participant Flow|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868713|NCT01181323|P1|Participant Flow|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection
868714|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
868715|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
868716|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868717|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868718|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
868719|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
868720|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868721|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868722|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868723|NCT01181323|O3|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
868724|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868725|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868726|NCT01181323|O1|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868727|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
868728|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
868729|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
868730|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
868731|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
868732|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
868733|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
868734|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
868735|NCT01181323|O4|Outcome|Infant TIV 2012-2013|Infants of women enrolled to receive TIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
868736|NCT01181323|O3|Outcome|Infant TIV 2011-2012|Infants of women enrolled to receive TIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
868737|NCT01181323|O2|Outcome|Infant LAIV 2012-2013|Infants of women enrolled to receive LAIV in the 2012-2013 season were enrolled separately in the protocol to be followed for safety outcomes.
868738|NCT01181323|O1|Outcome|Infant LAIV 2011-2012|Infants of women enrolled to receive LAIV in the 2011-2012 season were enrolled separately in the protocol to be followed for safety outcomes.
868739|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
868740|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
868741|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868742|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868743|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868744|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868745|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868746|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868747|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868748|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868749|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868750|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868751|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
868752|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
868753|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868754|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868755|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
868756|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
868757|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868758|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868759|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
868760|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
868761|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868762|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868763|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868764|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
868765|NCT01181323|O4|Outcome|Maternal TIV 2012-2013|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2012-2013 season
868932|NCT01181050|B2|Baseline|Placebo|Subjects received a single dose of placebo
868766|NCT01181323|O3|Outcome|Maternal TIV 2011-2012|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection in the 2011-2012 season
868767|NCT01181323|O2|Outcome|Maternal LAIV 2012-2013|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2012-2013 season
868768|NCT01181323|O1|Outcome|Maternal LAIV 2011-2012|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally in the 2011-2012 season
868769|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868770|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
868771|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868772|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868773|NCT01181323|O2|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868774|NCT01181323|O1|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
868775|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868776|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
868777|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868778|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868779|NCT01181323|O4|Outcome|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868780|NCT01181323|O3|Outcome|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
868781|NCT01181323|O2|Outcome|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868782|NCT01181323|O1|Outcome|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868783|NCT01181323|E4|Reported Event|Infant TIV|Infants of women enrolled to receive TIV were enrolled separately in the protocol to be followed for safety outcomes.
868784|NCT01181323|E3|Reported Event|Infant LAIV|Infants of women enrolled to receive LAIV were enrolled separately in the protocol to be followed for safety outcomes.
868785|NCT01181323|E2|Reported Event|Maternal TIV|Healthy women who planned to breast feed for 28 days post vaccination received 0.5 mL licensed seasonal trivalent influenza vaccine (TIV) by intramuscular injection, Fluzone®, by intramuscular injection, and 0.2 mL sucrose phosphate placebo intranasally.
868786|NCT01181323|E1|Reported Event|Maternal LAIV|Healthy women who planned to breast feed through 28 days post vaccination received 0.2 mL of licensed live attenuated influenza vaccine (LAIV), Flumist®, intranasally, and 0.5 ml of sterile saline placebo by intramuscular injection.
868787|NCT01181271|B1|Baseline|Autologous Then Allogeneic Transplant|Autologous then allogeneic stem cell transplantation
868788|NCT01181271|P1|Participant Flow|Autologous Then Allogeneic Transplant|Autologous, then Allogeneic Stem Cell Transplantation
868789|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868790|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868791|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868813|NCT01181167|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868792|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868793|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868794|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868795|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868796|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868797|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868798|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868799|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868800|NCT01181271|O1|Outcome|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868801|NCT01181271|E1|Reported Event|Autologous Then Allogeneic Transplant|"All patients will receive conditioning with busulfan, etoposide, and cyclophosphamide (with mesna) and then will undergo autologous (auto) peripheral blood stem cell transplantation.~Patients will be re-evaluated after autologous transplant prior to proceeding to non-myeloablative allogeneic (allo) transplant. If eligible to proceed, allogenic transplantation will take place no earlier than 40 days and no later than 180 days after autologous stem cell transplantation.~Conditioning for the allogeneic transplant will consist of fludarabine and busulfan. Participants will receive tacrolimus and sirolimus as prophylaxis against graft versus host disease (GVHD)."
868814|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868815|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868933|NCT01181050|B1|Baseline|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
868802|NCT01181258|B1|Baseline|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
868803|NCT01181258|P1|Participant Flow|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
868804|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
868805|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
868806|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
868807|NCT01181258|O1|Outcome|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
868808|NCT01181258|E1|Reported Event|Patients Receiving NK Cell Infusion|"Non-Myeloablative Conditioning Using Rituximab, Fludarabine, Cyclophosphamide and Methylprednisolone followed by Interleukin 2-activated Allogeneic Natural Killer Cells infusion for Patients with Refractory NHL and CLL~Rituximab: 375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)~Interleukin-2: subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.~Natural killer cells: administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)~Cyclophosphamide: 60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine~Methylprednisolone: 1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion~Fludarabine: 25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through"
868809|NCT01181167|B3|Baseline|Total|Total of all reporting groups
868810|NCT01181167|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868811|NCT01181167|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868812|NCT01181167|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868816|NCT01181167|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868817|NCT01181167|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868818|NCT01181167|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868819|NCT01181167|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868820|NCT01181141|B3|Baseline|Total|Total of all reporting groups
868821|NCT01181141|B2|Baseline|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
868822|NCT01181141|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
868823|NCT01181141|P2|Participant Flow|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
868824|NCT01181141|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
868825|NCT01181141|O2|Outcome|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
868826|NCT01181141|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
868827|NCT01181141|E2|Reported Event|Enoxaparin Sodium|"Enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~Enoxaparin sodium 20mg"
868828|NCT01181141|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~DU-176b (edoxaban)"
868829|NCT01181128|B4|Baseline|Total|Total of all reporting groups
868830|NCT01181128|B3|Baseline|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868831|NCT01181128|B2|Baseline|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868832|NCT01181128|B1|Baseline|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868833|NCT01181128|P3|Participant Flow|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868834|NCT01181128|P2|Participant Flow|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868835|NCT01181128|P1|Participant Flow|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868836|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
868837|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
868838|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
868839|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
868840|NCT01181128|O1|Outcome|Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
868841|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868842|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868843|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868844|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868845|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868846|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868847|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868848|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868849|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868850|NCT01181128|O2|Outcome|Arm 1: Individualized Prophylaxis, Prestudy On-demand|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868851|NCT01181128|O1|Outcome|Arm 1: Individualized Prophylaxis, Prestudy Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868852|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868853|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868854|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868855|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868856|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868857|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868858|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868859|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868860|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868861|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868878|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
892106|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
868862|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868863|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868864|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868865|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868866|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868867|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868868|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868869|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868870|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868871|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868872|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868873|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868874|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868875|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868876|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868877|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868880|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868881|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868882|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868883|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868884|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868885|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868886|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868887|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868888|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868889|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868890|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868891|NCT01181128|O1|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868892|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868893|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868934|NCT01181050|P2|Participant Flow|Placebo|Subjects received a single dose of placebo
868935|NCT01181050|P1|Participant Flow|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
868894|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868895|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868896|NCT01181128|O1|Outcome|Individualized (Tailored) Prophylaxis: Sequential PK Subgroup|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868897|NCT01181128|O2|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868898|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868899|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868900|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868901|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868902|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868903|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868904|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868905|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868906|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868936|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
868937|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
868938|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
868907|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868908|NCT01181128|O5|Outcome|Any Arm: Perioperative Management (Surgery) Subgroup|Participants from any arm who underwent major surgery. The surgical period and dosing were dependent on the type of surgery the participant underwent.
868909|NCT01181128|O4|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868910|NCT01181128|O3|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868911|NCT01181128|O2|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, rFVIIIFc Only|"On rFVIIIFc Day 0, participants underwent pharmacokinetic (PK) analysis with a single dose of 50 IU/kg rFVIIIFc in order to estimate their PK parameters and guide the appropriate dose or interval of dosing.~After the PK assessment, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by PK analyses, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868912|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis, Advate|"Participants underwent pharmacokinetic (PK) analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) and then a single dose of 50 IU/kg rFVIIIFc (rFVIIIFc Day 0) within 8 weeks of the Advate dose. A >= 96 hour washout from Advate or any other FVIII product was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via IV injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868913|NCT01181128|O4|Outcome|All Arms: Total|All participants from the Individualized (Tailored) Prophylaxis, Weekly Prophylaxis, and Episodic (On-Demand) Dosing arms.
868914|NCT01181128|O3|Outcome|Arm 3: Episodic (On-Demand) Dosing|10 to 50 IU/kg rFVIIIFc via IV injection, as required to treat a bleeding episode
868915|NCT01181128|O2|Outcome|Arm 2: Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868916|NCT01181128|O1|Outcome|Arm 1: Individualized (Tailored) Prophylaxis|"On rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with 50 IU/kg rFVIIIFc to estimate their PK parameters and guide the appropriate dose or interval of dosing. A subset of participants (Sequential PK subgroup) also had PK analyses performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout was performed before the PK dose of Advate or rFVIIIFc was administered. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~After PK assessments, all participants started twice weekly treatment with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days, as determined by rFVIIIFc PK analysis, to maintain a trough level of 1% to 3% (or higher, as clinically indicated) FVIII activity."
868917|NCT01181128|E3|Reported Event|Episodic (On-Demand) Dosing|Initial single dose of 50 IU/kg of rFVIIIFc via IV injection followed by 10 to 50 IU/kg rFVIIIFc, as required to treat a bleeding episode
868918|NCT01181128|E2|Reported Event|Weekly Prophylaxis|65 IU/kg of rFVIIIFc via IV injection every 7 days
868919|NCT01181128|E1|Reported Event|Individualized (Tailored) Prophylaxis, rFVIIIFc|"Initial twice weekly dosing with 25 IU/kg of rFVIIIFc via intravenous (IV) injection on Day 1 and 50 IU/kg on Day 4, followed by individualized dose and interval modification within the range of 25 to 65 IU/kg every 3 to 5 days to maintain a trough level of 1% to 3% (or higher, as clinically indicated) rFVIIIFc activity.~Prior to rFVIIIFc treatment, on rFVIIIFc Day 0, all participants underwent pharmacokinetic (PK) analysis with rFVIIIFc in order to estimate participant's PK parameters and guide the appropriate dose or interval of dosing. Repeat PK profiling with a single dose of 50 IU/kg rFVIIIFc was conducted at Week 14 or after 12 to 24 weeks of prophylaxis with rFVIIIFc.~A subset of participants (Sequential PK Subgroup) also had PK profiling performed with a single dose of 50 IU/kg Advate (Advate Day 0) within 8 weeks prior to rFVIIIFc Day 0. A >= 96 hour washout from Advate or any other FVIII product was performed before the first PK dose of rFVIIIFc was administered."
868920|NCT01181102|B3|Baseline|Total|Total of all reporting groups
868921|NCT01181102|B2|Baseline|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868922|NCT01181102|B1|Baseline|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868923|NCT01181102|P2|Participant Flow|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868924|NCT01181102|P1|Participant Flow|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868925|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868926|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868927|NCT01181102|O2|Outcome|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868928|NCT01181102|O1|Outcome|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868929|NCT01181102|E2|Reported Event|Enoxaparin Sodium|"enoxaparin sodium 20mg(=2000IU)/0.2ml twice daily, subcutaneous injection for 2 weeks~enoxaparin sodium"
868930|NCT01181102|E1|Reported Event|DU-176b|"DU-176b oral tablets, 30 mg., taken once daily for 2 weeks~edoxaban"
868939|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
868940|NCT01181050|O2|Outcome|Placebo|Subjects received a single dose of placebo
868941|NCT01181050|O1|Outcome|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
868942|NCT01181050|E2|Reported Event|Placebo|Subjects received a single dose of placebo
868943|NCT01181050|E1|Reported Event|4.0 mg/kg|Subjects received a single dose of 4 mg/kg NNC0142-0002
868944|NCT01181011|B1|Baseline|All Participants|all patients will be assigned to 6 treatment sequences. cross-over design was adopted to ensure each patient would take amlodipine/telmisartan/combination single dose in randomized order
868945|NCT01181011|P1|Participant Flow|All Participants|
868946|NCT01181011|O3|Outcome|Amlodipine 5mg|
868947|NCT01181011|O2|Outcome|Telmisartan 80mg|
868948|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868949|NCT01181011|O3|Outcome|Amlodipine 5mg|
868950|NCT01181011|O2|Outcome|Telmisartan 80mg|
868951|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868952|NCT01181011|O2|Outcome|Amlodipine 5mg|
868953|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868954|NCT01181011|O2|Outcome|Amlodipine 5mg|
868955|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868956|NCT01181011|O2|Outcome|Amlodipine 5mg|
868957|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868958|NCT01181011|O2|Outcome|Amlodipine 5mg|
868959|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868960|NCT01181011|O2|Outcome|Amlodipine 5mg|
868961|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868962|NCT01181011|O2|Outcome|Amlodipine 5mg|
868963|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868964|NCT01181011|O2|Outcome|Telmisartan 80mg|
868965|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868966|NCT01181011|O2|Outcome|Telmisartan 80mg|
868967|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868968|NCT01181011|O2|Outcome|Telmisartan 80mg|
868969|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868970|NCT01181011|O2|Outcome|Telmisartan 80mg|
868971|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868972|NCT01181011|O2|Outcome|Telmisartan 80mg|
868973|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868974|NCT01181011|O2|Outcome|Telmisartan 80mg|
868975|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868976|NCT01181011|O2|Outcome|Amlodipine 5mg|
868977|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868978|NCT01181011|O2|Outcome|Amlodipine 5mg|
868979|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868980|NCT01181011|O2|Outcome|Amlodipine 5mg|
868981|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868982|NCT01181011|O2|Outcome|Telmisartan 80mg|
868983|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868984|NCT01181011|O2|Outcome|Telmisartan 80mg|
868985|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868986|NCT01181011|O2|Outcome|Telmisartan 80mg|
868987|NCT01181011|O1|Outcome|Telmisartan 80mg, Amlodipine 5mg|
868988|NCT01181011|E3|Reported Event|Amlodipine 5mg|
868989|NCT01181011|E2|Reported Event|Telmisartan 80mg|
868990|NCT01181011|E1|Reported Event|Telmisartan 80mg, Amlodipine 5mg|
868991|NCT01180998|B4|Baseline|Total|Total of all reporting groups
868992|NCT01180998|B3|Baseline|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
868993|NCT01180998|B2|Baseline|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
868994|NCT01180998|B1|Baseline|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
868995|NCT01180998|P3|Participant Flow|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
868996|NCT01180998|P2|Participant Flow|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
868997|NCT01180998|P1|Participant Flow|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
868998|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
868999|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, used one of two toric lenses in a daily wear modality.
869000|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
869001|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
869002|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
869003|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
869004|NCT01180998|O3|Outcome|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses used one of two toric lenses in a daily wear modality.
869205|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869005|NCT01180998|O2|Outcome|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, and used one of two toric lenses in a daily wear modality.
869006|NCT01180998|O1|Outcome|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users used one of two toric lenses in a daily wear modality.
869007|NCT01180998|E3|Reported Event|Habitual Correction With Spectacles (Neophytes)|Habitual spectacle lens wearers (for vision correction) who have never used or been fitted with contact lenses will use one of two toric lenses in a daily wear modality.
869008|NCT01180998|E2|Reported Event|Contact Lens Drop-outs|Habitual spectacle users (for vision correction) who have failed contact lens fit and wear, will use one of two toric lenses in a daily wear modality.
869009|NCT01180998|E1|Reported Event|Spherical Contact Lens Users|Habitual spherical contact lens (non-toric lens) users will use one of two toric lenses in a daily wear modality.
869010|NCT01180985|B1|Baseline|All Subjects|All enrolled subjects at baseline.
869011|NCT01180985|P2|Participant Flow|Comfilcon A (Control)/Galyfilcon A (Test)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
869012|NCT01180985|P1|Participant Flow|Galyfilcon A (Test)/Comfilcon A (Control)|Each subject wore the assigned lens type for 7 +/- 1 days, according to the randomization scheme.
869013|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All subjects who wore galyfilcon A lenses
869014|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All subjects who wore comfilcon A lenses
869015|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
869016|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
869017|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
869018|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
869019|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
869020|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
869021|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
869022|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
869023|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
869024|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
869025|NCT01180985|O2|Outcome|Galyfilcon A Lens (Test)|All eyes of subjects who wore galyfilcon A lenses for 7 +/- 1 days to the time of evaluation
869026|NCT01180985|O1|Outcome|Comfilcon A Lens (Control)|All eyes of subjects who wore comfilcon A lenses for 7 +/-1 days to the time of evaluation
869027|NCT01180985|E1|Reported Event|Galyfilcon A Prototype/Comfilcon A|All enrolled subjects were to wear both lenses through the course of the study.
869028|NCT01180894|B3|Baseline|Total|Total of all reporting groups
869029|NCT01180894|B2|Baseline|Placebo|"Placebo~100 mg Normal saline"
869030|NCT01180894|B1|Baseline|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
869031|NCT01180894|P2|Participant Flow|Placebo|Placebo (100 mg normal saline)
869032|NCT01180894|P1|Participant Flow|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
869033|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
869034|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
869035|NCT01180894|O2|Outcome|Placebo|Placebo (100 mg normal saline)
869036|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
869037|NCT01180894|O2|Outcome|Placebo|"Placebo~100 mg Normal saline"
869038|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
869039|NCT01180894|O2|Outcome|Placebo|"Pacebo - Normal Saline~Placebo"
869040|NCT01180894|O1|Outcome|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
869041|NCT01180894|E2|Reported Event|Placebo|"Placebo~100 mg Normal saline"
869042|NCT01180894|E1|Reported Event|Iron Sucrose|"100 mg IV TIW~Iron sucrose: 100 mg IV TIW"
869043|NCT01180790|B8|Baseline|Total|Total of all reporting groups
869044|NCT01180790|B7|Baseline|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869045|NCT01180790|B6|Baseline|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869046|NCT01180790|B5|Baseline|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869047|NCT01180790|B4|Baseline|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869048|NCT01180790|B3|Baseline|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869049|NCT01180790|B2|Baseline|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869050|NCT01180790|B1|Baseline|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869051|NCT01180790|P7|Participant Flow|Segment 2 - 800 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
869052|NCT01180790|P6|Participant Flow|Segment 2 - 400 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
869053|NCT01180790|P5|Participant Flow|Segment 2: 200 mg ACH-0141625 for 12 Weeks|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for up to 24 or 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for up to 24 or 48 weeks"
869054|NCT01180790|P4|Participant Flow|Segment 1: Placebo for 28 Days|"Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869055|NCT01180790|P3|Participant Flow|Segment 1: 800 mg ACH-0141625 for 28 Days|"ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869056|NCT01180790|P2|Participant Flow|Segment 1: 400 mg ACH-0141625 for 28 Days|"ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869057|NCT01180790|P1|Participant Flow|Segment 1: 200 mg ACH-0141625 for 28 Days|"ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869058|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869059|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869060|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869061|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869062|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869063|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869064|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869065|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869066|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869067|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869068|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
892107|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
869069|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869070|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869071|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869072|NCT01180790|O7|Outcome|Segment 2 : 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869073|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869074|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869075|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869076|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869077|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869078|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869079|NCT01180790|O7|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869080|NCT01180790|O6|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869081|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily for~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869082|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869083|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869084|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869085|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869086|NCT01180790|O7|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869087|NCT01180790|O6|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869088|NCT01180790|O5|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869089|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869090|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869091|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869092|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869093|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869094|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869095|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily for 28 days or for 12 weeks~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for 48 weeks~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869096|NCT01180790|O4|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869097|NCT01180790|O3|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869098|NCT01180790|O2|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869099|NCT01180790|O1|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869100|NCT01180790|O3|Outcome|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily for 28 days~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869101|NCT01180790|O2|Outcome|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~Ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869102|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869103|NCT01180790|O3|Outcome|Segment 2: 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869104|NCT01180790|O2|Outcome|Segment 2: 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a plus ribavirin for up to 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869105|NCT01180790|O1|Outcome|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN alpha-2a and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869106|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869107|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869108|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869109|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869110|NCT01180790|O4|Outcome|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869111|NCT01180790|O3|Outcome|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869112|NCT01180790|O2|Outcome|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection for~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869113|NCT01180790|O1|Outcome|Segment 1: Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869114|NCT01180790|E7|Reported Event|Segment 1 - Placebo|"Placebo for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~Placebo: Powder in capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869115|NCT01180790|E6|Reported Event|Segment 2 - 800 mg ACH-0141625|"800 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869116|NCT01180790|E5|Reported Event|Segment 2 - 400 mg ACH-0141625|"400 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869117|NCT01180790|E4|Reported Event|Segment 2: 200 mg ACH-0141625|"200 mg ACH-0141625 for 12 weeks plus Peg-IFN and ribavirin for up to a total of 24 or 48 weeks~ACH-0141625: 200 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869118|NCT01180790|E3|Reported Event|Segment 1: 800 mg ACH-0141625|"800 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 800 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869119|NCT01180790|E2|Reported Event|Segment 1: 400 mg ACH-0141625|"400 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a plus ribavirin for 48 weeks~ACH-0141625: 400 mg oral capsule once daily~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily for 48 weeks"
869120|NCT01180790|E1|Reported Event|Segment 1: 200 mg ACH-0141625|"200 mg ACH-0141625 for 28 days plus Peg-IFN alpha-2a and ribavirin for 48 weeks~ACH-0141625: 200 mg oral capsule~Pegylated Interferon alpha-2a: 180 ug once a week by subcutaneous injection~ribavirin: 400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily"
869121|NCT01180777|B1|Baseline|All Subjects|Subjects were to wear all three lenses over the course of the study.
869122|NCT01180777|P1|Participant Flow|All Subjects|All subjects who enrolled, randomized, and exposed to the study lenses. Subjects where randomized to a study arm and wore all three of the study lenses by study completion. Randomization was to the arms as outlined in the 'arms' section of the protocol.
869123|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
869124|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
869125|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
869126|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
869127|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
869128|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
869129|NCT01180777|O3|Outcome|Etafilcon A (C)|Daily wear contact lens
869130|NCT01180777|O2|Outcome|Etafilcon A (B)|Daily wear contact lens
869131|NCT01180777|O1|Outcome|Etafilcon A (A)|Daily wear contact lens
869132|NCT01180777|E1|Reported Event|All Subjects|Subjects were to wear all three lenses over the course of the study. Due to the non-ocular related AE, all subjects are summarized to report the occurrence of event.
869133|NCT01180660|B3|Baseline|Total|Total of all reporting groups
869134|NCT01180660|B2|Baseline|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
869135|NCT01180660|B1|Baseline|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
869136|NCT01180660|P2|Participant Flow|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
869137|NCT01180660|P1|Participant Flow|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
869138|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
869139|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
869140|NCT01180660|O2|Outcome|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
869141|NCT01180660|O1|Outcome|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
869142|NCT01180660|E2|Reported Event|Placebo|"Placebo Normal Saline Infusion~Normal Saline: Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period"
869812|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869143|NCT01180660|E1|Reported Event|Lidocaine|"Lidocaine infusion~Lidocaine Infusion: 1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period"
869144|NCT01180647|B3|Baseline|Total|Total of all reporting groups
869145|NCT01180647|B2|Baseline|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869146|NCT01180647|B1|Baseline|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869147|NCT01180647|P2|Participant Flow|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869148|NCT01180647|P1|Participant Flow|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869149|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869150|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869151|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869152|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869153|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869154|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869155|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869156|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869157|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869158|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869159|NCT01180647|O2|Outcome|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869160|NCT01180647|O1|Outcome|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869161|NCT01180647|E2|Reported Event|Motivational Enhancement Counseling Only|"The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.~Motivational Enhancement Counseling: The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail."
869162|NCT01180647|E1|Reported Event|Extended-release Naltrexone (XR-NTX)|"A single 380mg IM depot injection of XR-NTX in the week prior to release from jail. A second 380mg IM injection is offered to persons in the XR-NTX arm post-release and 4 weeks after the initial injection.~Extended-Release Naltrexone: 380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly)."
869163|NCT01180400|B3|Baseline|Total|Total of all reporting groups
869164|NCT01180400|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869165|NCT01180400|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869166|NCT01180400|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869167|NCT01180400|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869168|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869169|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869170|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869171|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869172|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869173|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869174|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869175|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869176|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869177|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869178|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869179|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869180|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869181|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869182|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869183|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869184|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869185|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869186|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869187|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869188|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869189|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869190|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869191|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869192|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869193|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869194|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869195|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869196|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869197|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869198|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869199|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869200|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869201|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869202|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869203|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869204|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869206|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869207|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869208|NCT01180400|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869209|NCT01180400|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869210|NCT01180400|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
869211|NCT01180400|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
869212|NCT01180296|B3|Baseline|Total|Total of all reporting groups
869213|NCT01180296|B2|Baseline|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
869214|NCT01180296|B1|Baseline|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
869215|NCT01180296|P2|Participant Flow|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
869216|NCT01180296|P1|Participant Flow|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
869217|NCT01180296|O2|Outcome|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
869218|NCT01180296|O1|Outcome|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
869219|NCT01180296|E2|Reported Event|Placebo|Placebo tablets identical to 400 mg micronized progesterone study drug taken daily at bedtime from 16 to 34 weeks or delivery
869220|NCT01180296|E1|Reported Event|Progesterone Group|400 mg oral micronized progesterone daily at bedtime from 16 to 34 weeks or delivery
869221|NCT01180244|B3|Baseline|Total|Total of all reporting groups
869222|NCT01180244|B2|Baseline|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869223|NCT01180244|B1|Baseline|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869224|NCT01180244|P2|Participant Flow|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869225|NCT01180244|P1|Participant Flow|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869226|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869227|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869228|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869229|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869230|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869300|NCT01179919|E1|Reported Event|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
869301|NCT01179737|B5|Baseline|Total|Total of all reporting groups
892108|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
869231|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869232|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869233|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869234|NCT01180244|O2|Outcome|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869235|NCT01180244|O1|Outcome|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869236|NCT01180244|E2|Reported Event|Placebo Group|"Subjects in this group will be provided the same experience as those in the active treatment arm, but will not receive the noninvasive cortical stimulation signal from the treatment device~Sham treatment: Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal."
869237|NCT01180244|E1|Reported Event|Active Treatment|"Subjects in this group will receive the noninvasive cortical stimulation signal from the treatment device~Noninvasive cortical electrical stimulation: Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm."
869238|NCT01180127|B5|Baseline|Total|Total of all reporting groups
869239|NCT01180127|B4|Baseline|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869240|NCT01180127|B3|Baseline|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
869241|NCT01180127|B2|Baseline|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869242|NCT01180127|B1|Baseline|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
869243|NCT01180127|P4|Participant Flow|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869244|NCT01180127|P3|Participant Flow|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
869245|NCT01180127|P2|Participant Flow|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869246|NCT01180127|P1|Participant Flow|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
869247|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869248|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
869249|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869250|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
869251|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869252|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
869253|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869254|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
869255|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavonol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869256|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavonol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavonol"
869257|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavonol containing food product for 12 weeks~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869258|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavonol containing food product~Flavonol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
869259|NCT01180127|O4|Outcome|Wait List Control Food Additive Without Flavanol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869260|NCT01180127|O3|Outcome|Exercise, Food Additive Lacking Flavanol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
869261|NCT01180127|O2|Outcome|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869262|NCT01180127|O1|Outcome|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
869263|NCT01180127|E4|Reported Event|Wait List Control Food Additive Without Flavonol|"12 weeks of wait list control status plus food additive without the flavanol containing food product~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869264|NCT01180127|E3|Reported Event|Exercise, Food Additive Lacking Flavonol|"aerobic training plus food additive without flavanol~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR~Placebo food additive: 20 g serving, 2X/day, food additive lacking flavanol"
869265|NCT01180127|E2|Reported Event|no Exercise, Dietary Intervention|"wait list control plus flavanol containing food product for 12 weeks~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Wait list control: 12 week wait list control condition during which participant abstain from aerobic exercise"
869266|NCT01180127|E1|Reported Event|Exercise, Dietary Intervention|"aerobic training and flavanol containing food product~Flavanol containing food product: 12 weeks, 2X/day, 20g serving~Aerobic training: 4X/week, 1 hour/session at 75% maximum HR"
869267|NCT01180049|B3|Baseline|Total|Total of all reporting groups
869268|NCT01180049|B2|Baseline|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869269|NCT01180049|B1|Baseline|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869270|NCT01180049|P2|Participant Flow|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869271|NCT01180049|P1|Participant Flow|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869272|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869273|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869274|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
870227|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
869275|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869276|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869277|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869278|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869279|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869280|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869281|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869282|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869283|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869284|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869285|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869286|NCT01180049|O2|Outcome|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869287|NCT01180049|O1|Outcome|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869288|NCT01180049|E2|Reported Event|TEMSR 75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of TEMSR. An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received TEMSR 75 mg IV once weekly.
869289|NCT01180049|E1|Reported Event|TEMSR 175/75 mg|Partcipants had received desipramine 50 mg one week prior to the first dose of temsirolimus (TEMSR). An additional desipramine 50 mg was administered again approximately 30 min prior to every first dose of TEMSR on Day 1. Participants then received 175 mg intravenously (IV) once weekly for the first 3 weeks and followed by 75 mg once weekly thereafter.
869290|NCT01179984|B1|Baseline|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
869291|NCT01179984|P1|Participant Flow|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
869292|NCT01179984|O1|Outcome|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
869293|NCT01179984|O1|Outcome|Single-Arm|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
869294|NCT01179984|O1|Outcome|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
869295|NCT01179984|E1|Reported Event|PTA and Study Stent|The study population is comprised of subjects who present with lifestyle-limiting claudication or ischemic rest pain that are candidates for PTA and stenting.
869296|NCT01179919|B1|Baseline|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
869297|NCT01179919|P1|Participant Flow|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
869298|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
869299|NCT01179919|O1|Outcome|Oseltamivir Dosed Group|"Oseltamivir 75 mg by mouth every 12 hours for 9 doses~Oseltamivir: Capsule, 75 mg by mouth for 9 doses"
869302|NCT01179737|B4|Baseline|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
869303|NCT01179737|B3|Baseline|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
869304|NCT01179737|B2|Baseline|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
869305|NCT01179737|B1|Baseline|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
869306|NCT01179737|P4|Participant Flow|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
869307|NCT01179737|P3|Participant Flow|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
869308|NCT01179737|P2|Participant Flow|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
869309|NCT01179737|P1|Participant Flow|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
869310|NCT01179737|O1|Outcome|Total Number of Adverse Events and Serious Adverse Events|Adverse events were summarized by the number of patients having any adverse event overall and presented in the safety section.
869311|NCT01179737|O1|Outcome|Change in Pulmonary Vascular Resistance (PVR)|"Change in pulmonary vascular resistance is measured via right heart catheter assessment according to local hospital procedures. It assesses several prognostic hemodynamic variables in pulmonary hypertension, including Pulmonary Vascular Resistance (PVR).~Additional information about the outcome measure, if needed for clarification. Outcome Measures are: Specific key measurement(s) or observation(s) used to measure the effect of experimental variables in a study, or for observational studies, to describe patterns of diseases or traits or associations with exposures, risk factors or treatment.~Examples:~Title: all cause mortality Time Frame: one year Safety Issue: No~Title: Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI Time Frame: within the first 30 days (plus or minus 3 days) after surgery Safety Issue: Yes"
869312|NCT01179737|O1|Outcome|Change in Six-Minute Walk Distance (6MWD) From Baseline|During standardized walk course participants are connected to a portable pulse oximeter via a finger probe and instructed to walk at a comfortable speed for as far as they could manage in 6 minu
869313|NCT01179737|E4|Reported Event|Cohort 2: Placebo|Participants were assigned to receive placebo to match 50mg and / or 150mg capsules during 168 days
869314|NCT01179737|E3|Reported Event|Cohort 2: Nilotinib|Participants were assigned to receive nilotinib 300 mg during 168 days
869315|NCT01179737|E2|Reported Event|Cohort 1: Placebo|Participants were assigned to receive placebo to nilotinib to match 50 mg and 150 mg capsules during 168 days.
869316|NCT01179737|E1|Reported Event|Cohort 1: Nilotinib|Participants were assigned to receive nilotinib 50 mg during 14 days, followed by 150 mg during 14 days, followed by 300 mg during 140 days.
869317|NCT01179672|B3|Baseline|Total|Total of all reporting groups
869318|NCT01179672|B2|Baseline|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869319|NCT01179672|B1|Baseline|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1 then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869320|NCT01179672|P2|Participant Flow|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869321|NCT01179672|P1|Participant Flow|Duloxetine|30 milligrams (mg) duloxetine capsule administered orally, once daily (QD) during Week 1 then 60 mg duloxetine capsule orally, QD for the remaining 11 weeks of treatment. After a total 12 weeks of treatment or early discontinuation participants tapered off study drug (30 mg duloxetine capsule QD) for 1 week during taper.
869322|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869323|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869324|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869325|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869326|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869327|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869328|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869329|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869330|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869331|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper
869332|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
871307|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
869333|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869334|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869335|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869336|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869337|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869338|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869339|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally, QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869340|NCT01179672|O2|Outcome|Placebo|Placebo administered orally, QD for 12 weeks of the treatment and orally, QD for 1 week during taper.
869341|NCT01179672|O1|Outcome|Duloxetine|30 mg duloxetine capsule administered orally, QD during Week 1, then 60 mg duloxetine capsule orally QD for remaining 11 weeks of the treatment. After a total 12 weeks of treatment or early discontinuation, participants tapered off study drug (30 mg duloxetine capsule orally, QD) for 1 week during taper.
869342|NCT01179672|E4|Reported Event|Placebo Taper|After 12 weeks of treatment or early discontinuation, placebo administered orally, QD for 1 week during taper.
869343|NCT01179672|E3|Reported Event|Duloxetine Taper|After 12 weeks of treatment or early discontinuation, 30 mg duloxetine capsule administered orally, QD for 1 week during taper.
869344|NCT01179672|E2|Reported Event|Placebo Treatment|Placebo administered orally, QD for 12 weeks of the treatment.
869345|NCT01179672|E1|Reported Event|Duloxetine Treatment|30 mg duloxetine capsule administered orally, QD during Week 1 of the treatment; 60 mg capsule administered orally, QD for remaining 11 weeks of the treatment;
869346|NCT01179568|B5|Baseline|Total|Total of all reporting groups
869347|NCT01179568|B4|Baseline|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
869348|NCT01179568|B3|Baseline|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869349|NCT01179568|B2|Baseline|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
869350|NCT01179568|B1|Baseline|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869351|NCT01179568|P4|Participant Flow|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
869352|NCT01179568|P3|Participant Flow|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869353|NCT01179568|P2|Participant Flow|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
869354|NCT01179568|P1|Participant Flow|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869355|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
869376|NCT01179516|B1|Baseline|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
870110|NCT01177813|B3|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
869356|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869357|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869358|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
869359|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869360|NCT01179568|O3|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
869361|NCT01179568|O2|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869362|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869363|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
869364|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869365|NCT01179568|O4|Outcome|Complicated Grief Treatment With Placebo (CGT With PLA)|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
869366|NCT01179568|O3|Outcome|Complicated Grief Treatment With Citalopram (CGT With CIT)|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869367|NCT01179568|O2|Outcome|Placebo (PLA; Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo (PLA): 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
869368|NCT01179568|O1|Outcome|Citalopram (CIT)|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869369|NCT01179568|E4|Reported Event|CGT With Placebo|"The targeted psychotherapy for complicated grief combined with inactive medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Placebo: 16 weeks of daily inactive medication. Medication is administered in a double-blind fashion."
869370|NCT01179568|E3|Reported Event|CGT With Citalopram|"The targeted psychotherapy for complicated grief combined with SSRI medication.~Complicated Grief Treatment: Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869371|NCT01179568|E2|Reported Event|Placebo (Sugar Pill)|"Inactive medication. It is combined with grief-focused clinical management.~Placebo: 16 weeks of daily inactive medication. It is administered in a double-blind fashion."
869372|NCT01179568|E1|Reported Event|Citalopram|"Citalopram is an Selective Serotonin Reuptake Inhibitor (SSRI) medication. It is combined with grief-focused clinical management.~Citalopram: 16 weeks of medication provided flexibly up to 40 mg/day. Medication is administered in a double-blind fashion."
869373|NCT01179516|B4|Baseline|Total|Total of all reporting groups
869374|NCT01179516|B3|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869375|NCT01179516|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
892109|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
869377|NCT01179516|P3|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869378|NCT01179516|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869379|NCT01179516|P1|Participant Flow|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869380|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869381|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869382|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869383|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869384|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869385|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869386|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869387|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869388|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869389|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869390|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869391|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869392|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869393|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869394|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869395|NCT01179516|O3|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869396|NCT01179516|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869397|NCT01179516|O1|Outcome|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869398|NCT01179516|E3|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
869399|NCT01179516|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
869400|NCT01179516|E1|Reported Event|Placebo|Vortioxetine placebo-matching capsules, orally, once daily for up to 8 weeks.
869401|NCT01179490|B1|Baseline|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869402|NCT01179490|P1|Participant Flow|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869403|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869404|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869405|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869406|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
892110|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
869407|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869408|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869409|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869410|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869411|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869412|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869413|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869414|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869415|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869416|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869417|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869418|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869419|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869456|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869420|NCT01179490|O1|Outcome|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869421|NCT01179490|E1|Reported Event|SyB L-0501 + Prednisolone|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible. Prednisolone (60 mg/m2/day) will be administered orally for 4 consecutive days and the course will be observed for the next 24 days.
869422|NCT01179399|B1|Baseline|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
869423|NCT01179399|P1|Participant Flow|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
869424|NCT01179399|O1|Outcome|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
869425|NCT01179399|E1|Reported Event|TAK-960|Given orally (PO) for 21 days of a 28-day treatment cycle.
869426|NCT01179347|B3|Baseline|Total|Total of all reporting groups
869427|NCT01179347|B2|Baseline|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869428|NCT01179347|B1|Baseline|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869429|NCT01179347|P2|Participant Flow|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869430|NCT01179347|P1|Participant Flow|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869431|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869432|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869433|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869434|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869435|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869436|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869437|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869438|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869439|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869440|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869441|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869442|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869443|NCT01179347|O2|Outcome|Tio R5 qd|Tiotropium 5 mcg qd delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869444|NCT01179347|O1|Outcome|Placebo|Matching Placebo once daily (qd) delivered by the Respimat inhaler as add-on therapy to usual care in patients with cystic fibrosis.
869445|NCT01179347|E4|Reported Event|Tio 5mcg Randomized Group Over the Study|
869446|NCT01179347|E3|Reported Event|Placebo Randomized Group Over the Open−Label Period|
869447|NCT01179347|E2|Reported Event|Tio 5mcg Randomized Group Over the Double−Blind Period|
869448|NCT01179347|E1|Reported Event|Placebo Randomized Group Over the Double−Blind Period|
869449|NCT01179334|B3|Baseline|Total|Total of all reporting groups
869450|NCT01179334|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869451|NCT01179334|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869452|NCT01179334|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869453|NCT01179334|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869454|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869455|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869510|NCT01179048|B3|Baseline|Total|Total of all reporting groups
869457|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869458|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869459|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869460|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869461|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869462|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869463|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869464|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869465|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869466|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869467|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869468|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869469|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869470|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869471|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869472|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869473|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869474|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869475|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869476|NCT01179334|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869477|NCT01179334|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869478|NCT01179334|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869601|NCT01178671|E2|Reported Event|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
892111|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
869479|NCT01179334|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks. Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
869480|NCT01179191|B1|Baseline|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869481|NCT01179191|P1|Participant Flow|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869482|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869483|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869484|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869485|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869486|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869487|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869488|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869489|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869490|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869491|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869492|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869493|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869494|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869495|NCT01179191|O1|Outcome|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869496|NCT01179191|E1|Reported Event|EMBEDA|EMBEDA (morphine sulfate/naltrexone hydrochloride) extended-release capsules orally prescribed according to usual clinical practice using a standardized conversion guide. Treatment included titration phase (up to 6 weeks) followed by maintenance phase (8 weeks).
869497|NCT01179113|B3|Baseline|Total|Total of all reporting groups
869498|NCT01179113|B2|Baseline|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
869499|NCT01179113|B1|Baseline|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
869500|NCT01179113|P2|Participant Flow|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
869501|NCT01179113|P1|Participant Flow|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
869502|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
869503|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
869504|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
869505|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
869506|NCT01179113|O2|Outcome|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
869507|NCT01179113|O1|Outcome|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
869508|NCT01179113|E2|Reported Event|Esmolol|Loading: 0.5 mg/kg bolus during induction Infusion: 15 mcg /kg/min, infusion intraoperatively
869509|NCT01179113|E1|Reported Event|Placebo|A normal saline bolus during induction, and an infusion of normal saline intraoperatively.
869511|NCT01179048|B2|Baseline|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869512|NCT01179048|B1|Baseline|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869513|NCT01179048|P2|Participant Flow|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869514|NCT01179048|P1|Participant Flow|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869515|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869516|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869517|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869518|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869519|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869520|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869521|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869522|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869523|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869524|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869525|NCT01179048|O2|Outcome|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869526|NCT01179048|O1|Outcome|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869764|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869527|NCT01179048|E2|Reported Event|Placebo|Subjects received placebo (matched to liraglutide) daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Placebo was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869528|NCT01179048|E1|Reported Event|Liraglutide|Subjects received liraglutide once daily by subcutaneous injection in the abdomen, thigh or upper arm, at any time of the day and irrespective of meals, for a treatment period of 42 to 60 months. It was recommended to keep the time of injection consistent from day to day. Liraglutide was initiated at a dose of 0.6 mg and up-titrated to 1.2 mg after 1 week and to 1.8 mg after one additional week up to 42-60 months.
869529|NCT01178853|B3|Baseline|Total|Total of all reporting groups
869530|NCT01178853|B2|Baseline|Rosuvastatin/Pitavastatin|
869531|NCT01178853|B1|Baseline|Pitavastatin/Rosuvastatin|
869532|NCT01178853|P2|Participant Flow|Rosuvastatin/Pitavastatin|
869533|NCT01178853|P1|Participant Flow|Pitavastatin/Rosuvastatin|
869534|NCT01178853|O2|Outcome|Warfarin + Rosuvastatin|
869535|NCT01178853|O1|Outcome|Warfarin + Pitavastatin|
869536|NCT01178853|E2|Reported Event|Warfarin + Rosuvastatin|
869537|NCT01178853|E1|Reported Event|Warfarin + Pitavastatin|
869538|NCT01178827|B4|Baseline|Total|Total of all reporting groups
869539|NCT01178827|B3|Baseline|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869540|NCT01178827|B2|Baseline|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869541|NCT01178827|B1|Baseline|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869542|NCT01178827|P3|Participant Flow|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869543|NCT01178827|P2|Participant Flow|Oxybutynin IR|Oxybutynin IR (oxybutynin immediate release) 5 mg, three times daily for 2 days
869544|NCT01178827|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride), 60mg once daily for 10 days
869545|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869546|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869547|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869548|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869549|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869550|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869551|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869552|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869553|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869554|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869555|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869556|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869557|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869558|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869559|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869560|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869561|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869562|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869563|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869564|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869565|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869566|NCT01178827|O3|Outcome|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869567|NCT01178827|O2|Outcome|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869568|NCT01178827|O1|Outcome|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869569|NCT01178827|E3|Reported Event|Oxybutynin IR Placebo|Oxybutynin IR placebo three times daily for 2 days
869570|NCT01178827|E2|Reported Event|Oxybutynin IR|Oxybutynin IR (5 mg) three times daily for 2 days
869571|NCT01178827|E1|Reported Event|Sanctura XR®|Sanctura XR® (60mg) once daily for 10 days
869572|NCT01178762|B1|Baseline|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
869573|NCT01178762|P1|Participant Flow|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
869574|NCT01178762|O1|Outcome|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
869575|NCT01178762|E1|Reported Event|Azithromycin|DFA positive chlamydial conjunctivitis patients were orally administered azithromycin (400mg~1000mg, according to their age and body weight) once a week for consecutive two weeks, and the DFA tests were repeated 4 weeks after the treatment. If the DFA tests still showed positive results, an additional dose of azithromycin was orally administered, and another DFA test was performed again 4 weeks later. The augmented treatment with oral azithromycin (administration of one oral dose followed by DFA testing 4 weeks later) was continued until the DFA tests showed negative results.
869576|NCT01178671|B3|Baseline|Total|Total of all reporting groups
869577|NCT01178671|B2|Baseline|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869578|NCT01178671|B1|Baseline|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869579|NCT01178671|P2|Participant Flow|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869580|NCT01178671|P1|Participant Flow|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869581|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869582|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869583|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869584|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869585|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869586|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869587|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869588|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869589|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869590|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869591|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869592|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869593|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869594|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869595|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869596|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869597|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869598|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869599|NCT01178671|O2|Outcome|Sertraline and Sugar Pill|"Sertraline and Sugar pill for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks~Sugar pill: Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks"
869600|NCT01178671|O1|Outcome|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869602|NCT01178671|E1|Reported Event|Sertraline and Mirtazapine|"Flexible dose of both medications for up to 24 weeks~Mirtazapine: Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks~Sertraline: Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks"
869603|NCT01178528|B4|Baseline|Total|Total of all reporting groups
869604|NCT01178528|B3|Baseline|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
869605|NCT01178528|B2|Baseline|Carvedilol|up to 25 mg b.i.d.
869606|NCT01178528|B1|Baseline|Ivabradine|up to 7.5 mg b.i.d.
869607|NCT01178528|P3|Participant Flow|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
869608|NCT01178528|P2|Participant Flow|Carvedilol|up to 25 mg b.i.d.
869609|NCT01178528|P1|Participant Flow|Ivabradine|up to 7.5 mg b.i.d.
869610|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
869611|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
869612|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
869613|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
869614|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
869615|NCT01178528|O1|Outcome|Ivabradine|7.5 mg b.i.d.
869616|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
869617|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
869618|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
869619|NCT01178528|O3|Outcome|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
869620|NCT01178528|O2|Outcome|Carvedilol|up to 25 mg b.i.d.
869621|NCT01178528|O1|Outcome|Ivabradine|up to 7.5 mg b.i.d.
869622|NCT01178528|E3|Reported Event|Carvedilol and Ivabradine|up to 12.5 / 5 mg b.i.d.
869623|NCT01178528|E2|Reported Event|Carvedilol|up to 25 mg b.i.d.
869624|NCT01178528|E1|Reported Event|Ivabradine|up to 7.5 mg b.i.d.
869625|NCT01178385|B3|Baseline|Total|Total of all reporting groups
869626|NCT01178385|B2|Baseline|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
869627|NCT01178385|B1|Baseline|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
869628|NCT01178385|P2|Participant Flow|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
869629|NCT01178385|P1|Participant Flow|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
869630|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
869631|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
869632|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
869633|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
869657|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869634|NCT01178385|O2|Outcome|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
869635|NCT01178385|O1|Outcome|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
869636|NCT01178385|E2|Reported Event|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
869637|NCT01178385|E1|Reported Event|Cognitive-behavioral Therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
869638|NCT01178333|B4|Baseline|Total|Total of all reporting groups
869639|NCT01178333|B3|Baseline|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869640|NCT01178333|B2|Baseline|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869641|NCT01178333|B1|Baseline|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869642|NCT01178333|P3|Participant Flow|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869643|NCT01178333|P2|Participant Flow|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869644|NCT01178333|P1|Participant Flow|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869645|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869646|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869647|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869648|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869649|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869650|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869651|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869652|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869653|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869654|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869655|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869656|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869658|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869659|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869660|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
869661|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
869662|NCT01178333|O2|Outcome|OD Result >= 1.0|Heparin-PF4 OD Test Results >= 1.0
869663|NCT01178333|O1|Outcome|OD Result < 1.0|Heparin-PF4 OD Test Results < 1.0
869664|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869665|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869666|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869667|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869668|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869669|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869670|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869671|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869672|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869673|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869674|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869675|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869676|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869677|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869678|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869679|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869680|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869681|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869682|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869683|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869684|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869685|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869686|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869716|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869687|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869688|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869689|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869690|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869691|NCT01178333|O3|Outcome|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869692|NCT01178333|O2|Outcome|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869693|NCT01178333|O1|Outcome|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869694|NCT01178333|E3|Reported Event|No HIT|Positive heparin-PF4 ELISA test with heparin exposure in the preceding 5 days, but not meeting criteria for HIT-T or isolated HIT.
869695|NCT01178333|E2|Reported Event|Isolated HIT|Positive heparin-PF4 ELISA test and a nadir platelet count <50% of baseline platelet count associated with heparin exposure in the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), without a thrombotic event.
869696|NCT01178333|E1|Reported Event|HIT-T|Positive heparin-PF4 ELISA test and a thrombotic event associated with heparin exposure within the preceding 5 days (and with the onset of a platelet count drop of >15% beginning within 5-10 days after starting heparin), with or without thrombocytopenia.
869697|NCT01178294|B1|Baseline|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869698|NCT01178294|P1|Participant Flow|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869699|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869700|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869701|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869702|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869703|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869704|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869705|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869706|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869707|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869708|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869709|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869710|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869711|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869712|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869713|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869714|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869715|NCT01178294|O1|Outcome|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869717|NCT01178294|E1|Reported Event|OBI-1|Initial dose: 200 U/kg - additional doses at the discretion of the investigator based on FVIII activity level and clinical assessment of response to treatment (upper limit: 400 U/kg every 2 hours)
869718|NCT01178281|B3|Baseline|Total|Total of all reporting groups
869719|NCT01178281|B2|Baseline|Placebo (Oral Capsule)|Matching oral placebo Days 1 through Day 168
869720|NCT01178281|B1|Baseline|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
869721|NCT01178281|P2|Participant Flow|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
869722|NCT01178281|P1|Participant Flow|Pomalidomide 0.5 mg (Oral Capsule)|Pomalidomide 0.5 mg by mouth daily Days 1 through Day 168
869723|NCT01178281|O2|Outcome|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
869724|NCT01178281|O1|Outcome|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
869725|NCT01178281|E2|Reported Event|Placebo (Oral Capsule)|One matching capsule by mouth daily Days 1 through Day 168
869726|NCT01178281|E1|Reported Event|Pomalidomide 0.5mg (Oral Capsule)|Pomalidomide 0.5mg by mouth daily Days 1 through Day 168
869727|NCT01178268|B3|Baseline|Total|Total of all reporting groups
869728|NCT01178268|B2|Baseline|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869729|NCT01178268|B1|Baseline|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869730|NCT01178268|P2|Participant Flow|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869731|NCT01178268|P1|Participant Flow|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869732|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869733|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869734|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869735|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869736|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869737|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869738|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869739|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869740|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869741|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869742|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869743|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869744|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869745|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869746|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869747|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869748|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869749|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869750|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869751|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869752|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869753|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869754|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869755|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869756|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869757|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869758|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869759|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869760|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869761|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869762|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869763|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869765|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869766|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869767|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869768|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869769|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869770|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869771|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869772|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869773|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869774|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869775|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869776|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869777|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869778|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869779|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869780|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869781|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869782|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869783|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869784|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869785|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869786|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869787|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869788|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869789|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869790|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869791|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869792|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869793|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869794|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869795|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869796|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869797|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869798|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869799|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869800|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869801|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869802|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869803|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869804|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869805|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869806|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869807|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869808|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869809|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869810|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869811|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869813|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869814|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869815|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869816|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869817|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869818|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869819|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869820|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869821|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869822|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869823|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869824|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869825|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869826|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869827|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869828|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869829|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869830|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869831|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869832|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869833|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869834|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869835|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869836|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869837|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869838|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869839|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869840|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869841|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869842|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869843|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869844|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869845|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869846|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869847|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869848|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869849|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869850|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869851|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869852|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869853|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869854|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869855|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869856|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869857|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869858|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869859|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869860|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869861|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869862|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869863|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869864|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869865|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869866|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869867|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869868|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869869|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869870|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869871|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869872|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869873|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869874|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869875|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869876|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869877|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869878|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869879|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869880|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869881|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869882|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869883|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869884|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869885|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869886|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869887|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869888|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869889|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869890|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869891|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869892|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869893|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869894|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869895|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869896|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869897|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869898|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869899|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869900|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869901|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869902|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869903|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869904|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869905|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869906|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869907|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869908|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869909|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869910|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869911|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869912|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869913|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869914|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869915|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869916|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869917|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869918|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869919|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869920|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869921|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869922|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869923|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869924|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869925|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869926|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869927|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869928|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869929|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869930|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869931|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869932|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869933|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869934|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869935|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869936|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869937|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869938|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869939|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869940|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869941|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869942|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869943|NCT01178268|O2|Outcome|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869944|NCT01178268|O1|Outcome|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869945|NCT01178268|E2|Reported Event|CYPHER SELECT PLUS SECSS|"Patients who will receive this stent.~CYPHER SELECT PLUS SECSS: Patients who will receive this stent."
869946|NCT01178268|E1|Reported Event|XIENCE V EECSS|"Patients who will receive this stent.~XIENCE V EECSS: Patients who will receive this stent."
869987|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869988|NCT01178125|O2|Outcome|DR-102: Endpoint|at Week 51 of treatment with desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869989|NCT01178125|O1|Outcome|DR-102: Baseline|prior to starting desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869990|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869947|NCT01178138|B1|Baseline|Prazosin Effects on Methamphetamine|"The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 – 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg)~Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg)~Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg)~Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
869948|NCT01178138|P1|Participant Flow|Prazosin Effects on Methamphetamine|"Double blind, placebo controlled study of the effect of prazosin on methamphetamine~The order of placebo vs. active medication will be randomized.~oral placebo and methamphetamine 20mg po: Methamphetamine 20mg po will be given 30 minutes after oral placebo.~General Study Design. The Methamphetamine Tolerance regimen will always occur in the first study session. The medication regimen in sessions 2-6 will be randomized to one of the following five combinations of oral prazosin and iv methamphetamine.~Session 1 (Monday) Sessions 2 - 6 (Wed, Fri, Mon, Wed, Fri).~Oral placebo + methamphetamine (0, 15, 15 mg/70 kg) Oral placebo + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 2 mg po + methamphetamine placebo (0, 0, 0 mg/70 kg) Prazosin 1 mg po + methamphetamine (0, 15, 15 mg/70 kg) Prazosin 2 mg po + methamphetamine (0, 15, 15 mg/70 kg)"
869949|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
869950|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
869951|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
869952|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
869953|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
869954|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
869955|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
869956|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
869957|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
869958|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
869959|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
869960|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
869961|NCT01178138|O6|Outcome|Prazosin Placebo and Methamphetamine 20 mg|
869962|NCT01178138|O5|Outcome|Prazosin 2 mg and Methamphetamine 20 mg|
869963|NCT01178138|O4|Outcome|Prazosin 1 mg and Methamphetamine 20 mg|
869964|NCT01178138|O3|Outcome|Prazosin 2 mg and Methamphetamine Placebo|
869965|NCT01178138|O2|Outcome|Prazosin 1 mg and Methamphetamine Placebo|
869966|NCT01178138|O1|Outcome|Prazosin Placebo and Methamphetamine Placebo|The order of placebo vs. active medication was be randomized to determine the how much, if any, prazosin changed the effects of methamphetamine. Visual analog scales were used to determine effects. Because only 1 subject completed the study, measures of dispersion were not reported.
869967|NCT01178138|E1|Reported Event|Prazosin Effects on Methamphetamine|Randomized placebo controlled trial of prazosin effects on methamphetamine
869968|NCT01178125|B1|Baseline|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869969|NCT01178125|P1|Participant Flow|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869970|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869971|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869972|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869973|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869974|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869975|NCT01178125|O1|Outcome|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869976|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
869977|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
869978|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869979|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
869980|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
869981|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869982|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
869983|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
869984|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869985|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
869986|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
892112|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
869991|NCT01178125|O3|Outcome|DR-102: Baseline Body Weight ≥90 kg|Subpopulation of total participants with a Baseline body weight ≥90 kg
869992|NCT01178125|O2|Outcome|DR-102: Baseline Body Weight <90 kg|Subpopulation of total participants with a Baseline body weight <90 kg
869993|NCT01178125|O1|Outcome|DR-102: Total|All participants taking desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869994|NCT01178125|E1|Reported Event|DR-102|desogestrel/ethinyl estradiol 0.15/0.02 mg for 21 days then ethinyl estradiol 0.01 mg for 7 days
869995|NCT01178099|B5|Baseline|Total|Total of all reporting groups
869996|NCT01178099|B4|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
869997|NCT01178099|B3|Baseline|Prasugrel 10 mg SD; 5 mg MD (Sickle Cell Disease)|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (MD).
869998|NCT01178099|B2|Baseline|Prasugrel 10 mg SD; 7.5 mg MD (Healthy)|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
869999|NCT01178099|B1|Baseline|Prasugrel 10 mg SD; 5 mg MD (Healthy)|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
870000|NCT01178099|P2|Participant Flow|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870001|NCT01178099|P1|Participant Flow|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870002|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870003|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870004|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870005|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870006|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870007|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870008|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870009|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870010|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870011|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870012|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870013|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870014|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870015|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870016|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870017|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870018|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870019|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870104|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
870020|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870021|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870022|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870023|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870024|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870025|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870026|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870027|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870028|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870029|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870030|NCT01178099|O2|Outcome|Prasugrel Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870031|NCT01178099|O1|Outcome|Prasugrel Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).
870032|NCT01178099|E6|Reported Event|All Prasugrel Sickle Cell Disease Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870033|NCT01178099|E5|Reported Event|Prasugrel 10/7.5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870034|NCT01178099|E4|Reported Event|Prasugrel 10/5 mg Sickle Cell Disease|Participants received a single 10-mg dose on Day 1 (SD), followed by 5 mg/day (for participants<60 kg) for an additional 11 days (MD).
870035|NCT01178099|E3|Reported Event|All Prasugrel Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by either 5 mg/day (for participants<60 kg) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870036|NCT01178099|E2|Reported Event|Prasugrel 10/7.5 mg Healthy Participants|Participants received a single 10-mg dose on Day 1 (SD), followed by 7.5 mg/day (for participants≥60 kg) for an additional 11 days (MD).
870037|NCT01178099|E1|Reported Event|Prasugrel 10/5 mg Healthy Participants|Participants received a single 10-milligram (mg) dose on Day 1 (single dose [SD]), followed by 5 mg/day (for participants<60 kilograms [kg]) for an additional 11 days (multiple dose [MD]).
870038|NCT01178073|B4|Baseline|Total|Total of all reporting groups
870039|NCT01178073|B3|Baseline|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870040|NCT01178073|B2|Baseline|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870041|NCT01178073|B1|Baseline|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870042|NCT01178073|P3|Participant Flow|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870043|NCT01178073|P2|Participant Flow|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870105|NCT01177943|E2|Reported Event|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
871308|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
870044|NCT01178073|P1|Participant Flow|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870045|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870046|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870047|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870048|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870049|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870050|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870051|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870052|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870053|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870054|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870055|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870056|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870057|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870106|NCT01177943|E1|Reported Event|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
870107|NCT01177813|B6|Baseline|Total|Total of all reporting groups
892113|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
870058|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870059|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870060|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870061|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870062|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870063|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870064|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870065|NCT01178073|O4|Outcome|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870066|NCT01178073|O3|Outcome|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870067|NCT01178073|O2|Outcome|Monotherapy Pooled: Ambrisentan or Tadalafil|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks; or one tablet of 20 mg TAD and one tablet of TAD-matching placebo QD for the first 4 weeks. For participants on TAD, the dose of TAD was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and for participants on AMB, the dose of AMB may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870068|NCT01178073|O1|Outcome|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870069|NCT01178073|E3|Reported Event|Tadalafil Monotherapy|Participants initially received one tablet of 20 mg TAD and one tablet of TAD matching placebo QD for the first 4 weeks plus two tablets of AMB matching placebo. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) and two tablets of AMB matching placebo after 4 weeks.
870070|NCT01178073|E2|Reported Event|Ambrisentan Monotherapy|Participants initially received one tablet of 5 mg AMB and one tablet of AMB matching placebo QD for the first 8 weeks plus two tablets of TAD matching placebo. The AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) and two tablets of TAD matching placebo after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870071|NCT01178073|E1|Reported Event|Combination Therapy: Ambrisentan + Tadalafil|Participants initially received one tablet of 5 milligrams (mg) ambrisentan (AMB) and one tablet of AMB matching placebo once daily (QD) for the first 8 weeks plus one tablet of 20 mg tadalafil (TAD) and one tablet of TAD matching placebo QD for the first 4 weeks. The TAD dose was uptitrated to 40 mg (two tablets of 20 mg QD) after 4 weeks and the AMB dose may have been uptitrated to 10 mg (two tablets of 5 mg QD) after 8 weeks. The uptitration of AMB to 10 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
870072|NCT01177969|B3|Baseline|Total|Total of all reporting groups
892114|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
870073|NCT01177969|B2|Baseline|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
870074|NCT01177969|B1|Baseline|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
870075|NCT01177969|P2|Participant Flow|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
870076|NCT01177969|P1|Participant Flow|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
870077|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
870078|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
870079|NCT01177969|O2|Outcome|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
870080|NCT01177969|O1|Outcome|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
870081|NCT01177969|E2|Reported Event|Wait-list|"A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.~Wait-list: A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'."
870082|NCT01177969|E1|Reported Event|Cognitive-Behavioral Therapy|"The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.~Cognitive-Behavioral Therapy: The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques."
870083|NCT01177956|B1|Baseline|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870084|NCT01177956|P1|Participant Flow|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870085|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870086|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870108|NCT01177813|B5|Baseline|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
870109|NCT01177813|B4|Baseline|Sitagliptin 100|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
870087|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870088|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870089|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870090|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870091|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870092|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870093|NCT01177956|O1|Outcome|Cetuximab + Cisplatin + 5-FU|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity.
870094|NCT01177956|E2|Reported Event|Cetuximab + Cisplatin + 5-FU : Late Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. Participants with end of treatment date after the last trial treatment date + 30 days or still on trial at the cut-off date.
870095|NCT01177956|E1|Reported Event|Cetuximab + Cisplatin + 5-FU : Treatment Emergent Phase|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 75 mg/m^2 IV infusion over 60 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 750 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. On or after the first dosing day of trial treatment and until 30 days after the last trial treatment administration.
870096|NCT01177943|B3|Baseline|Total|Total of all reporting groups
870097|NCT01177943|B2|Baseline|Atomoxetine Capsule Followed by Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
870098|NCT01177943|B1|Baseline|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
870099|NCT01177943|P2|Participant Flow|Atomoxetine Capsule Formulation First, Then Oral Solution|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once. Participants received 50 mg of atomoxetine po, once (12.5 mL at 4 mg/mL).
870100|NCT01177943|P1|Participant Flow|Atomoxetine Oral Solution First, Then Capsule Formulation|Participants received 50 milligrams (mg) of atomoxetine orally (po), once (12.5 milliliters [mL] at 4 mg/mL). Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
870101|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
870102|NCT01177943|O1|Outcome|Atomoxetine Oral Solution|Participants received 50 mg of atomoxetine orally (po), once (12.5 mL at 4 mg/mL).
870103|NCT01177943|O2|Outcome|Atomoxetine Capsule Formulation|Participants received 2 capsules of atomoxetine (25 mg/capsule po), once.
870111|NCT01177813|B2|Baseline|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
870112|NCT01177813|B1|Baseline|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
870113|NCT01177813|P5|Participant Flow|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
870114|NCT01177813|P4|Participant Flow|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
870115|NCT01177813|P3|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
870116|NCT01177813|P2|Participant Flow|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
870117|NCT01177813|P1|Participant Flow|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
870118|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
870119|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
870120|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
870121|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
870122|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
870123|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
870124|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
870125|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
870126|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
870127|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
870128|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
870129|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
870130|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
870131|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
870132|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
870133|NCT01177813|O5|Outcome|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label once daily in the morning.
870134|NCT01177813|O4|Outcome|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
870135|NCT01177813|O3|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
870136|NCT01177813|O2|Outcome|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
870137|NCT01177813|O1|Outcome|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
870138|NCT01177813|E5|Reported Event|Empagliflozin 25 mg OL|Patients receive 25 mg Empagliflozin in tablets open label (OL) once daily in the morning.
870139|NCT01177813|E4|Reported Event|Sitagliptin 100 mg|Patients receive 100 mg Sitagliptin in tablets once daily in the morning.
870140|NCT01177813|E3|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily in the morning.
870141|NCT01177813|E2|Reported Event|Empagliflozin10 mg|Patients receive 10 mg Empagliflozin in tablets once daily in the morning.
870142|NCT01177813|E1|Reported Event|Placebo|Patients receive tablets identical to those containing 10 mg and 25 mg Empagliflozin and to Sitagliptin 100 mg once daily in the morning.
870143|NCT01177800|B3|Baseline|Total|Total of all reporting groups
870144|NCT01177800|B2|Baseline|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870145|NCT01177800|B1|Baseline|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870146|NCT01177800|P2|Participant Flow|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870147|NCT01177800|P1|Participant Flow|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870148|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870225|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
870226|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
870149|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870150|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870151|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870152|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870153|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870154|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870155|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870156|NCT01177800|O2|Outcome|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870157|NCT01177800|O1|Outcome|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870158|NCT01177800|E2|Reported Event|Placebo|Placebo infusion, matched to infliximab was given intravenously at Week 0, 2 and 6. At Week 10, 12 and 16, participants received 5 mg/kg infliximab intravenously. Placebo infusion was again given at Week 14 and 22. Total duration of treatment was 26 weeks.
870159|NCT01177800|E1|Reported Event|Infliximab|5 milligram per kilogram (mg/kg) infusion (a fluid or a medicine delivered into a vein by way of a needle) of infliximab administered intravenously (into a vein) at Week 0, 2 and 6 during induction treatment phase followed by maintenance regimen of 5 mg/kg infliximab at Week 14 and 22. Placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial infusion), matched to infliximab was given at Week 10, 12 and 16. Total duration of treatment was 26 weeks.
870160|NCT01177735|B1|Baseline|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
870161|NCT01177735|P1|Participant Flow|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
870162|NCT01177735|O1|Outcome|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
870163|NCT01177735|E1|Reported Event|Pomalidomide|Pomalidomide: Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
870164|NCT01177722|B5|Baseline|Total|Total of all reporting groups
870165|NCT01177722|B4|Baseline|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870166|NCT01177722|B3|Baseline|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870216|NCT01177553|E1|Reported Event|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
870217|NCT01177410|B4|Baseline|Total|Total of all reporting groups
870167|NCT01177722|B2|Baseline|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870168|NCT01177722|B1|Baseline|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870169|NCT01177722|P4|Participant Flow|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870170|NCT01177722|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870171|NCT01177722|P2|Participant Flow|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870172|NCT01177722|P1|Participant Flow|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870173|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870174|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870175|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870176|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870177|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870178|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870179|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870218|NCT01177410|B3|Baseline|Placebo|Placebo : placebo capsules once daily for 12 weeks
870219|NCT01177410|B2|Baseline|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
870220|NCT01177410|B1|Baseline|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
870221|NCT01177410|P3|Participant Flow|Placebo|Placebo : placebo capsules once daily for 12 weeks
870180|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870181|NCT01177722|O4|Outcome|Infanrix Hexa™|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870182|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870183|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870184|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870185|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870186|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870187|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870188|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870189|NCT01177722|O4|Outcome|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870190|NCT01177722|O3|Outcome|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870191|NCT01177722|O2|Outcome|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870192|NCT01177722|O1|Outcome|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870193|NCT01177722|E4|Reported Event|Infanrix Hexa|Participants received a 3-dose primary series of vaccinations with the licensed Infanrix hexa™, with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870222|NCT01177410|P2|Participant Flow|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
870194|NCT01177722|E3|Reported Event|DTaP-IPV-Hep B-PRP~T Batch C|Participants received a 3-dose primary series of vaccinations with Batch C of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870195|NCT01177722|E2|Reported Event|DTaP-IPV-Hep B-PRP~T Batch B|Participants received a 3-dose primary series of vaccinations with Batch B of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870196|NCT01177722|E1|Reported Event|DTap-IPV-Hep B-PRP~T Batch A|Participants received a 3-dose primary series of vaccinations with Batch A of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and poliomyelitis vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine [polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age. Prevenar™ was co-administered with study vaccine at 2, 4, and 6 months of age, and Rotarix™ was co-administered at 2 and 4 months of age.
870197|NCT01177709|B1|Baseline|Metformin|Metformin: metformin 500- 2500 mg/day.
870198|NCT01177709|P1|Participant Flow|Metformin|Metformin: metformin 500- 2500 mg/day.
870199|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
870200|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
870201|NCT01177709|O1|Outcome|Metformin|Metformin: metformin 500- 2500 mg/day.
870202|NCT01177709|E1|Reported Event|Metformin|Metformin: metformin 500- 2500 mg/day.
870203|NCT01177670|B1|Baseline|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
870204|NCT01177670|P1|Participant Flow|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
870205|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
870206|NCT01177670|O1|Outcome|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
870207|NCT01177670|E1|Reported Event|Enrolled|All subjects who met enrollment inclusion/exclusion criteria, signed informed consent form, had baseline data collected and Adiana procedure performed or attempted.
870208|NCT01177553|B3|Baseline|Total|Total of all reporting groups
870209|NCT01177553|B2|Baseline|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient’s perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
870210|NCT01177553|B1|Baseline|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
870211|NCT01177553|P2|Participant Flow|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
870212|NCT01177553|P1|Participant Flow|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
870213|NCT01177553|O2|Outcome|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
870214|NCT01177553|O1|Outcome|Surgery Group|"Patients randomized to surgery will have hospital arrangements (laboratory tests and anesthesia assessment) finalized for a surgery the next day. Patients will sign the informed consent form.~Patients undergoing surgery will be admitted to Tampa General Hospital and will complete usual hospital admission procedures."
870215|NCT01177553|E2|Reported Event|Expectant Management Group|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
870223|NCT01177410|P1|Participant Flow|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
870224|NCT01177410|O3|Outcome|Placebo|Placebo : placebo capsules once daily for 12 weeks
870228|NCT01177410|O2|Outcome|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
870229|NCT01177410|O1|Outcome|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
870230|NCT01177410|E3|Reported Event|Placebo|Placebo : placebo capsules once daily for 12 weeks
870231|NCT01177410|E2|Reported Event|Mesalamine Granules 750 mg|Mesalamine Granules 750 mg : 750 mg mesalamine granules once daily for 12 weeks
870232|NCT01177410|E1|Reported Event|Mesalamine Granules 1500 mg|Mesalamine Granules 1500 mg : 1500 mg mesalamine granules once daily for 12 weeks
870233|NCT01177384|B3|Baseline|Total|Total of all reporting groups
870234|NCT01177384|B2|Baseline|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
870235|NCT01177384|B1|Baseline|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
870236|NCT01177384|P2|Participant Flow|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
870237|NCT01177384|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
870238|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
870239|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
870240|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
870241|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
870242|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
870243|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
870244|NCT01177384|O2|Outcome|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
870245|NCT01177384|O1|Outcome|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
870246|NCT01177384|E2|Reported Event|Placebo|Placebo q.d. + acarbose (continuing the current stable dose of at least 50 mg t.i.d.)
870247|NCT01177384|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg daily (q.d.) + acarbose (continuing the current stable dose of at least 50 mg three times daily [t.i.d.])
870248|NCT01177293|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment first (amlodipine capsule first and amlodipine ODT first).
870249|NCT01177293|P2|Participant Flow|Amlodipine ODT Then Amlodipine Capsule|Single oral dose amlodipine besylate 10 mg ODT in first intervention period and single oral dose of amlodipine besylate 10 mg capsule in second intervention period. A washout period of 14 days was maintained between each period.
870250|NCT01177293|P1|Participant Flow|Amlodipine Capsule Then Amlodipine ODT|Single oral dose amlodipine besylate 10 mg capsule in first intervention period and single oral dose of amlodipine besylate 10 mg oral disintegrating tablet (ODT) in second intervention period. A washout period of 14 days was maintained between each period.
870251|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
870252|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
870253|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
870254|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
870255|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
870256|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
870257|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
870258|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
870259|NCT01177293|O2|Outcome|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
870260|NCT01177293|O1|Outcome|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
870261|NCT01177293|E2|Reported Event|Amlodipine 10 mg ODT|Single oral dose of amlodipine 10 mg ODT (Treatment B [Test]).
870262|NCT01177293|E1|Reported Event|Amlodipine 10 mg Capsule|Single oral dose of amlodipine 10 mg capsule (Treatment A [Reference]).
870263|NCT01177228|B5|Baseline|Total|Total of all reporting groups
870264|NCT01177228|B4|Baseline|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870265|NCT01177228|B3|Baseline|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg, IV infusion on Days 1, 15, 29 and 85.
870266|NCT01177228|B2|Baseline|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870267|NCT01177228|B1|Baseline|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
870268|NCT01177228|P4|Participant Flow|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg, IV infusion on Days 1, 15, 29 and 85.
870269|NCT01177228|P3|Participant Flow|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870270|NCT01177228|P2|Participant Flow|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg, IV infusion on Days 1, 15, 29 and 85.
870271|NCT01177228|P1|Participant Flow|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
870272|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870273|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870274|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870275|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
870276|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
892115|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
870277|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870278|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870279|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
870280|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870281|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870282|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870283|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
870284|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870285|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870286|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870287|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo IV infusion on Days 1, 15, 29 and 85.
870288|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870289|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870290|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870291|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870292|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870293|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870294|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870295|NCT01177228|O2|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870296|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870297|NCT01177228|O3|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870298|NCT01177228|O2|Outcome|Vedolizumab (6 mg/kg)|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870299|NCT01177228|O1|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870300|NCT01177228|O4|Outcome|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870301|NCT01177228|O3|Outcome|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870302|NCT01177228|O2|Outcome|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870303|NCT01177228|O1|Outcome|Placebo|Vedolizumab-matching placebo, intravenous (IV), one 30-minute infusion on Days 1, 15, 29 and 85.
870304|NCT01177228|E4|Reported Event|Vedolizumab 10 mg/kg|Vedolizumab 10 mg/kg IV infusion on Days 1, 15, 29 and 85.
870305|NCT01177228|E3|Reported Event|Vedolizumab 6 mg/kg|Vedolizumab 6 mg/kg IV infusion on Days 1, 15, 29 and 85.
870306|NCT01177228|E2|Reported Event|Vedolizumab 2 mg/kg|Vedolizumab 2 mg/kg IV infusion on Days 1, 15, 29 and 85.
870307|NCT01177228|E1|Reported Event|Placebo|Vedolizumab-matching placebo, intravenous (IV) infusion on Days 1, 15, 29 and 85.
870308|NCT01177098|B3|Baseline|Total|Total of all reporting groups
870309|NCT01177098|B2|Baseline|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870310|NCT01177098|B1|Baseline|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870311|NCT01177098|P2|Participant Flow|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870312|NCT01177098|P1|Participant Flow|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870313|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870314|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870315|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870316|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870317|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870318|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870319|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870320|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870321|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870322|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870499|NCT01176032|B2|Baseline|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870323|NCT01177098|O2|Outcome|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870324|NCT01177098|O1|Outcome|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870325|NCT01177098|E2|Reported Event|Bimatoprost/Timolol Fixed Combination Ophthalmic Solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
870326|NCT01177098|E1|Reported Event|Bimatoprost/Timolol Formulation A|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
870327|NCT01176968|B3|Baseline|Total|Total of all reporting groups
870328|NCT01176968|B2|Baseline|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870329|NCT01176968|B1|Baseline|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870330|NCT01176968|P2|Participant Flow|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870331|NCT01176968|P1|Participant Flow|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870332|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870333|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870334|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870335|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870336|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870337|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870338|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870339|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870340|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870341|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870342|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870343|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870344|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870345|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870346|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870347|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870348|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870349|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870350|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870351|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870352|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870353|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870354|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870355|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870356|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
892116|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
870357|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870358|NCT01176968|O2|Outcome|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870359|NCT01176968|O1|Outcome|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870360|NCT01176968|E2|Reported Event|Placebo Plus Standard of Care|Placebo group received matching placebo for eplerenone 25 milligram (mg) film coated tablets.
870361|NCT01176968|E1|Reported Event|Eplerenone Plus Standard of Care|Eplerenone group received eplerenone 25 milligram (mg) once daily (OD), and on day 2, the dose of study drug increased to 50 mg OD (2 tablets) if serum potassium <5.0 mmol/L and with normal renal function.
870362|NCT01176955|B3|Baseline|Total|Total of all reporting groups
870363|NCT01176955|B2|Baseline|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
870364|NCT01176955|B1|Baseline|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
870365|NCT01176955|P2|Participant Flow|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
870366|NCT01176955|P1|Participant Flow|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
870367|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
870368|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
870369|NCT01176955|O2|Outcome|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
870370|NCT01176955|O1|Outcome|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
870371|NCT01176955|O2|Outcome|Control|Patients received standard-of-care therapy without weekly Internet surveys.
870372|NCT01176955|O1|Outcome|Internet Survey|Patients received a weekly Internet survey to report on the status of their acne.
870373|NCT01176955|E2|Reported Event|Control|Subjects will receive standard-of-care treatment with the study medication, without internet surveys. Standard-of-care will mean patients are directed to take the medication daily and return for visits at 6 and 12 weeks.
870374|NCT01176955|E1|Reported Event|Internet Survey|Subjects will receive a weekly email link to complete an internet survey about their acne and use of the study medication.
870375|NCT01176877|B1|Baseline|Keloid Scar|Those with a diagnosis of keloid scar.
870376|NCT01176877|P1|Participant Flow|Keloid Scar|Subjects over the age of 18 with a clinical diagnosis of keloid scarring were included in the study. First, subjects completed a written questionnaire to collect demographic data, including personal history of keloid scarring, past and present use of keloid scar treatments, and internet access and use to find information related to keloid scars. Second, subjects completed a written questionnaire to assess knowledge about keloids. Next, subjects listened to a scripted, 5 minute educational lecture about keloid scars and then completed a written questionnaire to assess knowledge about keloids. Finally, subjects were contacted by phone 3 months later to complete a questionnaire to assess knowledge about keloids and to answer questions about keloid-related behaviors over the previous 3 months.
870377|NCT01176877|O1|Outcome|Keloid Scars|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. 3 months after the educational lecture, subjects completed an identical verbal questionnaire to assess knowledge about keloid scars.
870378|NCT01176877|O1|Outcome|Keloid Scar|Participants with keloid scars completed a written questionnaire to assess knowledge about keloid scars. Participants then listened to a scripted, 5 minute educational lecture about keloid scars. Immediately after the educational lecture, the subjects completed an identical written questionnaire to assess knowledge about keloid scars.
870379|NCT01176877|E1|Reported Event|Keloid Scar|
870380|NCT01176773|B1|Baseline|Juvéderm® Ultra Lip Injectable Gel|
870381|NCT01176773|P1|Participant Flow|Juvéderm® Ultra Lip Injectable Gel|
870382|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
870383|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
870384|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
870385|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
870386|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|
870387|NCT01176773|O1|Outcome|Juvéderm® Ultra Lip Injectable Gel|The Investigator determined the appropriate volume to inject based on clinical experience and the subject's cosmetic goals for lip enhancement.
870388|NCT01176773|E1|Reported Event|Juvéderm® Ultra Lip Injectable Gel|
870389|NCT01176565|B3|Baseline|Total|Total of all reporting groups
870415|NCT01176448|B1|Baseline|Patients With Scars|12 individual scars on 6 patients were treated. Each scar was divided in half, and the halves randomized to either fractionated laser resurfacing or dermabrasion.
870474|NCT01176058|B2|Baseline|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870475|NCT01176058|B1|Baseline|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870390|NCT01176565|B2|Baseline|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870391|NCT01176565|B1|Baseline|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870392|NCT01176565|P2|Participant Flow|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870393|NCT01176565|P1|Participant Flow|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater then the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870394|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870395|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870396|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870468|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870469|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870470|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
871310|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
870397|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870398|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870399|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870400|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870401|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870402|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870403|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870471|NCT01176240|E2|Reported Event|Placebo|"Placebo matched control~Placebo: Placebo~Placebo Safety set excludes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
870472|NCT01176240|E1|Reported Event|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment~Droxidopa Safety set includes 3 patients randomized to placebo who were mistakenly dosed with droxidopa for short periods of time during the trial."
870404|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870405|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870406|NCT01176565|O2|Outcome|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870407|NCT01176565|O1|Outcome|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870408|NCT01176565|E2|Reported Event|Intensive SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the intensive blood pressure reduction group was to reduce and maintain SBP under 140 mmHg for 24 hours from randomization. The target SBP for this treatment arm was 125 mmHg (the center of the treatment group range SBP 110 - 139 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP after infusion of the maximum nicardipine dose for 30 min, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was decreased incrementally or was discontinued if SBP fell below the assigned treatment range. Fluid bolus was given if needed for hypotension."
870409|NCT01176565|E1|Reported Event|Standard SBP Reduction Arm|"Nicardipine hydrochloride was used according to need as the primary agent in lowering systolic blood pressure (SBP).~The goal for the standard blood pressure reduction group was to reduce and maintain SBP under 180 mmHg for 24 hours from randomization. The target SBP for this treatment arm was approximately 160 mmHg (the center of the assigned treatment group range of SBP 140-179 mmHg).~Nicardipine hydrochloride: IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached.~If SBP was greater than the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent could be used (Labetalol 5-20 mg IV bolus every 15 min; urapidil substituted in countries without labetalol available) for another hour. Nicardipine use was to be decreased incrementally or was discontinued if SBP fell below the assigned treatment range."
870410|NCT01176513|B1|Baseline|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
870411|NCT01176513|P1|Participant Flow|GE 148-002|GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
870412|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
870413|NCT01176513|O1|Outcome|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
870414|NCT01176513|E1|Reported Event|GE 148-002|"GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.~Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons."
870473|NCT01176058|B3|Baseline|Total|Total of all reporting groups
870416|NCT01176448|P1|Participant Flow|Patients With Scars|"12 long scars were recruited for individual study. Only 6 patients were needed as each patient had two separate scars to be studied. Each scar was divided in half, and the halves randomized to fractionated laser resurfacing or dermabrasion.~The half of the scar randomized to fractionated CO2 laser was treated first. The Re:Pair CO2 laser was used, with a fluence of 40 mJ and a treatment level of 8 (Solta Medical Inc., Hayward, CA). Four passes of the laser were used in total, with two in the orthogonal direction. A standard diamond fraise dermabrader was used on the area painted with gentian violet down through the dermal–epidermal junction. Dermabrasion was performed until a uniform area of punctate bleeding was obtained, and the edges were feathered into the surrounding epidermis."
870417|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared. 6 patients had 12 scars treated (2 scars per patient.
870418|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser. 6 patients had 12 scars treated (2 scars per patient.
870419|NCT01176448|O2|Outcome|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
870420|NCT01176448|O1|Outcome|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
870421|NCT01176448|E2|Reported Event|Dermabrasion|Dermabrasion is the gold standard for scar resurfacing and will be used as the control against which Fractionated Laser is compared.
870422|NCT01176448|E1|Reported Event|Fractionated Laser|This Arm is the section of scar that will be treated with Fractionated Laser
870423|NCT01176292|B3|Baseline|Total|Total of all reporting groups
870424|NCT01176292|B2|Baseline|Rotating Platform Cruciate Substituting TKA|
870425|NCT01176292|B1|Baseline|Rotating Platform High-Flex Cruciate Substituting TKA|
870426|NCT01176292|P2|Participant Flow|Rotating Platform Cruciate Substituting TKA|
870427|NCT01176292|P1|Participant Flow|Rotating Platform High-Flex Cruciate Substituting TKA|
870428|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
870429|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
870430|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
870431|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
870432|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
870433|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
870434|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
870435|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
870436|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
870437|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
870438|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
870439|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
870440|NCT01176292|O2|Outcome|Rotating Platform Cruciate Substituting TKA|
870441|NCT01176292|O1|Outcome|Rotating Platform High-Flex Cruciate Substituting TKA|
870442|NCT01176292|E2|Reported Event|Rotating Platform Cruciate Substituting TKA|
870443|NCT01176292|E1|Reported Event|Rotating Platform High-Flex Cruciate Substituting TKA|
870444|NCT01176240|B5|Baseline|Total|Total of all reporting groups
870445|NCT01176240|B4|Baseline|Study 306B: Placebo|"Placebo matched control~Placebo: Placebo"
870446|NCT01176240|B3|Baseline|Study 306B: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870447|NCT01176240|B2|Baseline|Study 306A: Placebo|"Placebo matched control~Placebo: Placebo"
870448|NCT01176240|B1|Baseline|Study 306A: Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870449|NCT01176240|P2|Participant Flow|Placebo|"Placebo matched control~Placebo: Placebo"
870450|NCT01176240|P1|Participant Flow|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870451|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870452|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870453|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870454|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870455|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870456|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870457|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870458|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870459|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870460|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870461|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870462|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870463|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870464|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870465|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870466|NCT01176240|O1|Outcome|Droxidopa|"droxidopa active drug~Droxidopa: 100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment"
870467|NCT01176240|O2|Outcome|Placebo|"Placebo matched control~Placebo: Placebo"
870476|NCT01176058|P2|Participant Flow|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant’s tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870477|NCT01176058|P1|Participant Flow|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870478|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870479|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870480|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870481|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870482|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870483|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870484|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870485|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870486|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870487|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870488|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870489|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870490|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870491|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870492|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870493|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870494|NCT01176058|O2|Outcome|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870495|NCT01176058|O1|Outcome|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870496|NCT01176058|E2|Reported Event|Fluconazole|IV fluconazole 400 mg daily dose from Day 1 (dose reduction according to the participant's tolerability). Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870497|NCT01176058|E1|Reported Event|Anidulafungin|Intravenous (IV) Anidulafungin loading dose of 200 mg on Day 1 and then 100 mg daily from Day 2. Participants who completed a minimum of 7 days of IV treatment may have continued with IV treatment or may have been switched to oral fluconazole 400 mg daily up to a maximum of Day 42.
870498|NCT01176032|B3|Baseline|Total|Total of all reporting groups
870500|NCT01176032|B1|Baseline|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870501|NCT01176032|P2|Participant Flow|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870502|NCT01176032|P1|Participant Flow|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870503|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870504|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870505|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870506|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870507|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870508|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870509|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870510|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870511|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870512|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870513|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870514|NCT01176032|O3|Outcome|Losartan|losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870515|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870516|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870517|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870518|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870519|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870520|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870521|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870522|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870523|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870524|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870525|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870526|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870527|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870528|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870529|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870530|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870531|NCT01176032|O2|Outcome|Aliskiren + Amlodipinet|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870532|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870533|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870534|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870535|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870536|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870537|NCT01176032|O4|Outcome|Losartan + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870538|NCT01176032|O3|Outcome|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870753|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870539|NCT01176032|O2|Outcome|Aliskiren + Amlodipine|5 mg of amlodipine in addition to the study medication in order to reach the required BP (<140/90 mmHg). At week 18 the dose of amlodipine can be increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
870540|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870541|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870542|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870543|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870544|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870545|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870546|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870547|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870548|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870549|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870550|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870551|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870552|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870553|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870554|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870555|NCT01176032|O2|Outcome|Lostaran|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870556|NCT01176032|O1|Outcome|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870557|NCT01176032|E2|Reported Event|Losartan|Losartan 50 mg od for 2 weeks and up-titration to losartan 100 mg od for 34 weeks
870558|NCT01176032|E1|Reported Event|Aliskiren|Aliskiren 150 mg od for 2 weeks and up-titration to aliskiren 300 mg od for 34 weeks
870559|NCT01175902|B3|Baseline|Total|Total of all reporting groups
870560|NCT01175902|B2|Baseline|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870561|NCT01175902|B1|Baseline|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870562|NCT01175902|P2|Participant Flow|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870563|NCT01175902|P1|Participant Flow|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870564|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870565|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870566|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870567|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870568|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870569|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870570|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870571|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870572|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 2|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870573|NCT01175902|O1|Outcome|Latanoprost, Period 2|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870574|NCT01175902|O2|Outcome|Dorzolamide/Timolol, Period 1|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870575|NCT01175902|O1|Outcome|Latanoprost, Period 1|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870576|NCT01175902|E2|Reported Event|Dorzolamide/Timolol|"Patients on Dorzolamide/Timolol eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870577|NCT01175902|E1|Reported Event|Latanoprost|"Patients on Latanoprost eyedrops~dorzolamide/timolol fixed combination: Cosopt eyedrop, 2 times a day~latanoprost: compare with Cosopt one time a day"
870578|NCT01175850|B3|Baseline|Total|Total of all reporting groups
870579|NCT01175850|B2|Baseline|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
892117|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
870580|NCT01175850|B1|Baseline|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870581|NCT01175850|P2|Participant Flow|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
870582|NCT01175850|P1|Participant Flow|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
870583|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870584|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870585|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870586|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870587|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870588|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870589|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870590|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870591|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870592|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870593|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870594|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870595|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870596|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870597|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870598|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870599|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870600|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870601|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870602|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870603|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870604|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870605|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870606|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870635|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870607|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870608|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870609|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870610|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870611|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870612|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870613|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870614|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870615|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
870616|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870617|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm"
870618|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870619|NCT01175850|O2|Outcome|Standard PTA|"Standard angioplasty balloon without Paclitaxel drug-coating~Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870620|NCT01175850|O1|Outcome|Drug-Coated Balloon (DCB)|"Paclitaxel drug-coated angioplasty balloon~IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm."
870621|NCT01175850|E2|Reported Event|Standard PTA|"Standard Percutaneous Transluminal Angioplasty (PTA) Balloon: Balloon Angioplasty~PTA Balloon: Balloon Angioplasty: balloon dilatation and provisional stenting with standard non-coated PTA balloon"
870622|NCT01175850|E1|Reported Event|Drug-Coated Balloon (DCB)|"IN.PACT Admiral: Balloon Angioplasty~Drug-Coated Balloon (DCB): balloon dilatation and provisional stenting with IN.PACT DCB"
870623|NCT01175824|B3|Baseline|Total|Total of all reporting groups
870624|NCT01175824|B2|Baseline|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870625|NCT01175824|B1|Baseline|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870626|NCT01175824|P2|Participant Flow|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870627|NCT01175824|P1|Participant Flow|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870628|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870629|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870630|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870631|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870632|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870633|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870634|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
892118|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
870636|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870637|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870638|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870639|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870640|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870641|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870642|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870643|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870644|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870645|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870646|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870647|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870648|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870649|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870650|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870651|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870652|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870653|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870654|NCT01175824|O2|Outcome|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870655|NCT01175824|O1|Outcome|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870656|NCT01175824|E2|Reported Event|Insulin Glargine+Insulin Lispro|Once-daily injection (bedtime) basal insulin glargine and once-daily injection (before the meal with the highest average 2-hour postprandial blood glucose concentration) prandial insulin lispro. Participant-dependent doses, administered subcutaneously for 24 weeks.
870657|NCT01175824|E1|Reported Event|Insulin Lispro Low Mixture|Two daily injections (breakfast and dinner) of insulin lispro mix 75/25. Participant-dependent doses, administered subcutaneously for 24 weeks.
870658|NCT01175811|B3|Baseline|Total|Total of all reporting groups
870659|NCT01175811|B2|Baseline|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870660|NCT01175811|B1|Baseline|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870661|NCT01175811|P2|Participant Flow|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870662|NCT01175811|P1|Participant Flow|Premixed Insulin|"Twice daily (breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870691|NCT01175798|O1|Outcome|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
870663|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870664|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870665|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870666|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870667|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870668|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870669|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870670|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870671|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870672|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870673|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870674|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870675|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870676|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870677|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870678|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870679|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870680|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870681|NCT01175811|O2|Outcome|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870682|NCT01175811|O1|Outcome|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870683|NCT01175811|E2|Reported Event|Basal-Bolus|"Once daily (bedtime) insulin glargine and three pre-meal insulin lispro~Insulin Glargine: Participant dependent dose, administered subcutaneously for 24 weeks~Insulin Lispro: Participant dependent dose, administered subcutaneously for 24 weeks"
870684|NCT01175811|E1|Reported Event|Premixed Insulin|"Twice daily (before breakfast and lunch) insulin lispro mix 50 (LM50) and once daily (before dinner) insulin lispro mix 25 (LM25)~Insulin Lispro Mix: Participant dependent dose, administered subcutaneously for 24 weeks"
870685|NCT01175798|B3|Baseline|Total|Total of all reporting groups
870686|NCT01175798|B2|Baseline|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
870687|NCT01175798|B1|Baseline|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
870688|NCT01175798|P2|Participant Flow|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
870689|NCT01175798|P1|Participant Flow|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
870690|NCT01175798|O2|Outcome|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
870751|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870692|NCT01175798|E2|Reported Event|Vitamin D Repletion|"Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).~Cholecalciferol: 50,000 IU PO weekly x 6 weeks"
870693|NCT01175798|E1|Reported Event|No Treatment (Standard of Care)|Patients will be randomized in a 3:2 ratio to oral Vitamin D treatment, or standard of care (no repletion).
870694|NCT01175707|B3|Baseline|Total|Total of all reporting groups
870695|NCT01175707|B2|Baseline|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870696|NCT01175707|B1|Baseline|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870697|NCT01175707|P2|Participant Flow|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870698|NCT01175707|P1|Participant Flow|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870699|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870700|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870701|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870702|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870703|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870704|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870705|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870706|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870707|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870708|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870709|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870710|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870711|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870712|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870713|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870714|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870715|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870716|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870752|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870717|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870718|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted
870719|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870720|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870721|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870722|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870723|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870724|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870725|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870726|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870727|NCT01175707|O2|Outcome|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870728|NCT01175707|O1|Outcome|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870729|NCT01175707|E2|Reported Event|Vancomycin|Vancomycin monotherapy is administered according to prescribing physician's order with duration of treatment modified, if warranted, according to Investigator site's standard practice, and End of Treatment (EOT) is dependent on this. Dose adjustments of vancomycin will be suggested by the pharmacist and approved by prescribing or following physician.
870730|NCT01175707|E1|Reported Event|Daptomycin|500 milligrams (mg) daptomycin, administered intravenously (IV) for 7 to 10 days accordingly to the package insert or according to institutional practice, if warranted.
870731|NCT01175668|B3|Baseline|Total|Total of all reporting groups
870732|NCT01175668|B2|Baseline|NMS/Phenobarbital|
870733|NCT01175668|B1|Baseline|NMS/Clonidine|
870734|NCT01175668|P2|Participant Flow|NMS/Phenobarbital|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day +Phenobarbital 6 mg/kg/day 11-13 NMS 0.48 mg/kg/day +Phenobarbital 8 mg/kg/day 14-16 NMS 0.64 mg/kg/day +Phenobarbital 10 mg/kg/day ≥17 NMS 0.8 mg/kg/day* + Phenobarbital 12 mg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Phenobarbital dose was divided for q8h dosing interval~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
870735|NCT01175668|P1|Participant Flow|NMS/Clonidine|"Dosing was based on the Finnegan scores as below~Finn Score 8-10 NMS 0.32mg/kg/day + Clonidine 6 mcg/kg/day 11-13 NMS 0.48 mg/kg/day + Clonidine 8 mcg/kg/day 14-16 NMS 0.64 mg/kg/day + Clonidine 10 mcg/kg/day ≥17 NMS 0.8 mg/kg/day* + Clonidine 12 mcg/kg/day~Daily NMS dose was divided for q3h dosing interval Daily Clonidine dose was divided for q6h dosing interval Clonidine escalation may be limited by hypotension or bradycardia~*If needing morphine sulfate > 0.8 mg/kg/day, increase dose in increments of 0.16 mg/kg/day until Finnegan score < 8"
870736|NCT01175668|O2|Outcome|NMS/Phenobarbital|
870737|NCT01175668|O1|Outcome|NMS/Clonidine|
870738|NCT01175668|O2|Outcome|NMS/Phenobarbital|
870739|NCT01175668|O1|Outcome|NMS/Clonidine|
870740|NCT01175668|E2|Reported Event|NMS/Phenobarbital|
870741|NCT01175668|E1|Reported Event|NMS/Clonidine|
870742|NCT01175590|B3|Baseline|Total|Total of all reporting groups
870743|NCT01175590|B2|Baseline|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870744|NCT01175590|B1|Baseline|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870745|NCT01175590|P2|Participant Flow|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870746|NCT01175590|P1|Participant Flow|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870747|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870748|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870749|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870750|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870754|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870755|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870756|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870757|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870758|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870759|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870760|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870761|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870762|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870763|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870764|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870765|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870766|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870767|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870768|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870769|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870770|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870771|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870772|NCT01175590|O1|Outcome|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870773|NCT01175590|O2|Outcome|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870774|NCT01175590|O1|Outcome|Besivance|besifloxacin ophthalmic suspension 0.6% Besivance : Ocular administration to affected eye for 7 days
870775|NCT01175590|E2|Reported Event|Vehicle|"Vehicle of Besivance~Vehicle : Vehicle of Besivance administered to affected eye for 7 days"
870776|NCT01175590|E1|Reported Event|Besivance|"besifloxacin ophthalmic suspension 0.6%~Besivance : Ocular administration to affected eye for 7 days"
870777|NCT01175473|B3|Baseline|Total|Total of all reporting groups
870778|NCT01175473|B2|Baseline|Liraglutide|2-step initiation regimen of liraglutide: 0.6 mg QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
870779|NCT01175473|B1|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
870780|NCT01175473|P2|Participant Flow|Liraglutide|2-step initiation regimen of liraglutide: 0.6 milligram (mg) QD subcutaneously for 1 week, followed by 1.2 mg QD for 1 week, then 1.8 mg QD up to Week 4.
870781|NCT01175473|P1|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 4.
870782|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870783|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870784|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870785|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870786|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870787|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870788|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870789|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870790|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870791|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870792|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870793|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870794|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870795|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870796|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870797|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870798|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870799|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870800|NCT01175473|O2|Outcome|Liraglutide|2-step initiation regimen of liraglutide.
870801|NCT01175473|O1|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
870802|NCT01175473|E2|Reported Event|Liraglutide|2-step initiation regimen of liraglutide.
870803|NCT01175473|E1|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
870804|NCT01175434|B3|Baseline|Total|Total of all reporting groups
870805|NCT01175434|B2|Baseline|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
870848|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870806|NCT01175434|B1|Baseline|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
870807|NCT01175434|P2|Participant Flow|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
870808|NCT01175434|P1|Participant Flow|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
870809|NCT01175434|O2|Outcome|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
870810|NCT01175434|O1|Outcome|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
870811|NCT01175434|E2|Reported Event|Usual Care Group|Children in the Usual Care group will not receive preventive medications delivered at school. These children will continue to receive all of their asthma care from their parents and primary care physicians.
870812|NCT01175434|E1|Reported Event|School-Based Medication Group|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse will begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
870813|NCT01175395|B1|Baseline|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
870814|NCT01175395|P1|Participant Flow|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
870815|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
870816|NCT01175395|O1|Outcome|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
870817|NCT01175395|E1|Reported Event|IBI-20089/Lucentis|"Alternate treatment of either 6.9 mg IBI-20089/Lucentis or 13.8 mg IBI-20089/Lucentis~IBI-20089/Lucentis : Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results."
870818|NCT01175382|B4|Baseline|Total|Total of all reporting groups
870819|NCT01175382|B3|Baseline|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870820|NCT01175382|B2|Baseline|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870821|NCT01175382|B1|Baseline|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
870908|NCT01175369|E1|Reported Event|Usual Care|Usual asthma care
892119|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
870822|NCT01175382|P3|Participant Flow|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870823|NCT01175382|P2|Participant Flow|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870824|NCT01175382|P1|Participant Flow|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
870825|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870826|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870827|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870828|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870829|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870830|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870831|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870832|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870833|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870847|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870943|NCT01175213|B1|Baseline|Participants Aged 2 to <12 Years|
870834|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870835|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870836|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870837|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870838|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870839|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870840|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870841|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870842|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870843|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870844|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870845|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870846|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
871045|NCT01175005|P1|Participant Flow|Fever and a Central Venous Catheter|
871311|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
870849|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870850|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870851|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870852|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870853|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870854|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870855|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870856|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870857|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870858|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870859|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870860|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870861|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
871046|NCT01175005|O2|Outcome|Blood Culture Negative|Procalcitonin level in patients with fever and a CVC with negative blood culture
870862|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870863|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870864|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870865|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870866|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870867|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870868|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870869|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870870|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870871|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870872|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870873|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870874|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870875|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870876|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870877|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870878|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870879|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870880|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870881|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870882|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870883|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870884|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870885|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870886|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870887|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870888|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
871047|NCT01175005|O1|Outcome|Blood Culture Positive|Procalcitonin level in patients with fever and a CVC with positive blood culture
870889|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870890|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870891|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870892|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870893|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870894|NCT01175382|O3|Outcome|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870895|NCT01175382|O2|Outcome|Drug Therapy (Tolterodine + Tamsulosin)|"Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants in the drug group will receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).~Tolterodine + tamsulosin: Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily)."
870896|NCT01175382|O1|Outcome|Behavioral Treatment Alone|Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice.
870897|NCT01175382|E3|Reported Event|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870898|NCT01175382|E2|Reported Event|Drug Therapy Alone|Drug therapy for 6 weeks implemented in a clinic visit with telephone follow-up at 3 weeks, followed by 6 weeks of combined drug + behavioral therapy. Participants receive an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
870899|NCT01175382|E1|Reported Event|Behavioral Treatment Alone|Behavioral treatment implemented in 4 clinic visits over a period of 6 weeks, followed by 6 weeks of combined behavioral + drug therapy. Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency, and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, incremental delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
870900|NCT01175369|B3|Baseline|Total|Total of all reporting groups
870901|NCT01175369|B2|Baseline|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
870902|NCT01175369|B1|Baseline|Usual Care|Usual asthma care
870903|NCT01175369|P2|Participant Flow|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
870904|NCT01175369|P1|Participant Flow|Usual Care|Usual asthma care
870905|NCT01175369|O2|Outcome|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
870906|NCT01175369|O1|Outcome|Usual Care|Usual asthma care
870907|NCT01175369|E2|Reported Event|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
870909|NCT01175343|B1|Baseline|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870910|NCT01175343|P1|Participant Flow|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870911|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870912|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870913|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870914|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870915|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870916|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870917|NCT01175343|O1|Outcome|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870918|NCT01175343|E1|Reported Event|Treatment (RO4929097)|"Patients receive oral gamma-secretase inhibitor RO4929097 once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Blood and tumor tissue samples are collected for correlative studies. Ascitic fluid may also be collected.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
870919|NCT01175317|B3|Baseline|Total|Total of all reporting groups
870920|NCT01175317|B2|Baseline|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
870921|NCT01175317|B1|Baseline|Goald-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
870922|NCT01175317|P2|Participant Flow|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
870923|NCT01175317|P1|Participant Flow|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
870924|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
870925|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
870926|NCT01175317|O2|Outcome|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
870927|NCT01175317|O1|Outcome|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
870928|NCT01175317|E2|Reported Event|Regimen Based on Expertise Anaesthesist|Fluid regimen based on expertise anaesthesist
870929|NCT01175317|E1|Reported Event|Goal-directed Fluid Optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
870930|NCT01175226|B3|Baseline|Total|Total of all reporting groups
870931|NCT01175226|B2|Baseline|Placebo|Placebo: Placebo twice daily
870932|NCT01175226|B1|Baseline|BTA798|BTA798: BTA798 twice daily
870933|NCT01175226|P2|Participant Flow|Placebo|Placebo: Placebo twice daily
870934|NCT01175226|P1|Participant Flow|BTA798|BTA798: BTA798 twice daily
870935|NCT01175226|O2|Outcome|Placebo|Placebo: Placebo twice daily
870936|NCT01175226|O1|Outcome|BTA798|BTA798: BTA798 twice daily
870937|NCT01175226|E2|Reported Event|Placebo|Placebo: Placebo twice daily
870938|NCT01175226|E1|Reported Event|BTA798|BTA798: BTA798 twice daily
870939|NCT01175213|B5|Baseline|Total|Total of all reporting groups
870940|NCT01175213|B4|Baseline|Participants Aged 65 Years and Older|
870941|NCT01175213|B3|Baseline|Participants Aged 16 to <65 Years|
870942|NCT01175213|B2|Baseline|Participants Aged 12 to <16 Years|
870944|NCT01175213|P2|Participant Flow|IGIV, 10% Only|"Participants were treated with Immune Globulin Intravenous (Human) (IGIV), 10% only, via the intravenous (IV) route throughout the study.~Note: IGIV, 10% is the same product as IGSC, 10%."
870945|NCT01175213|P1|Participant Flow|IGSC - rHuPH20 Then IGSC, 10% or IGIV, 10% Only|"Efficacy and safety of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20). Participants then went into a safety follow-up with either SC administration of IGSC, 10% or intravenous (IV) administration of Immune Globulin Intravenous (Human) (IGIV), 10%, only. The IV or SC administration route was at the discretion of the participant and the investigator.~Note: IGIV, 10% is the same product as IGSC, 10%."
870946|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870947|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870948|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870949|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870950|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870951|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870952|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870953|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870954|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870955|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870956|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870957|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870958|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870959|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870960|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870961|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870962|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870963|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870964|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870965|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870966|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870967|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870968|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870969|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870970|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870971|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870972|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870973|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870974|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
870975|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
870976|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
870977|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20|All participants who had been exposed to recombinant human hyaluronidase (rHuPH20) in studies 160603 or 160902.
870978|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870979|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870980|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870981|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870982|NCT01175213|O2|Outcome|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870983|NCT01175213|O1|Outcome|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870984|NCT01175213|O1|Outcome|All Participants Treated With rHuPH20 and/or IGSC, 10%|"All participants who had been exposed to either or both study drugs in the Safety Analysis Data Set. Study drugs are Immune Globulin Subcutaneous Solution, 10%, (IGSC, 10%) and recombinant human hyaluronidase (rHuPH20).~This includes the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20. The 3 participants were treated at 4-week intervals only.~Number of participants in each treatment interval [N] is provided."
870985|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).~This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
870986|NCT01175213|O1|Outcome|All Participants Treated With IGSC, 10% and rHuPH20|"Participants treated with at least one dose of subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).~This does not include the 3 participants who received intravenous (IV) administration of IGSC, 10% without rHuPH20."
870987|NCT01175213|E2|Reported Event|Safety Follow-up - IGSC, 10% or IGIV, 10% Only|"All participants were included in the Safety Follow-up. Safety Follow-up occurred after discontinuation of treatment with recombinant human hyaluronidase (rHuPH20) and included participants who had been treated with intravenous administration of Immune Globulin Intravenous (Human) (IGIV), 10% only throughout the study (e.g. had never received rHuPH20 in this study).~At Safety Follow-up, the decision for treatment with either subcutaneous (SC) administration of Immune Globulin Subcutaneous (Human) (IGSC), 10% or IV administration of IGIV, 10% was at the discretion of the investigator and participant.~Note: IGIV, 10% is the same product as IGSC, 10%."
870988|NCT01175213|E1|Reported Event|IGSC, 10% - rHuPH20|Participants treated with subcutaneous (SC) administration of Immune Globulin Subcutaneous Solution (IGSC), 10% after SC administration of recombinant human hyaluronidase (rHuPH20).
870989|NCT01175148|B3|Baseline|Total|Total of all reporting groups
870990|NCT01175148|B2|Baseline|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
870991|NCT01175148|B1|Baseline|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
870992|NCT01175148|P2|Participant Flow|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
870993|NCT01175148|P1|Participant Flow|Recipient Arm|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
870994|NCT01175148|O1|Outcome|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
870995|NCT01175148|E2|Reported Event|Donor Arm|Sibling donors will start taking atorvastatin orally at 40mg once daily between 14-28 days before the anticipated first day of apheresis or bone marrow harvest.
871048|NCT01175005|E1|Reported Event|Fever and a Central Venous Catheter|
871049|NCT01174784|B1|Baseline|Enrolled/Primary Cohort|
871050|NCT01174784|P1|Participant Flow|Enrolled/Primary Cohort|
871051|NCT01174784|O1|Outcome|Enrolled/Primary Cohort|
870996|NCT01175148|E1|Reported Event|Recipient Arm - Experimental|"Atorvastatin will be administered at dose of 40mg orally daily starting on day -14, to permit an approximately 1-week observation period to rule out any acute atorvastatin-induced side effects before the initiation of transplant conditioning. Patients will receive atorvastatin until +180 days or development of grade 2 GVHD.~Atorvastatin calcium (Lipitor): 40 mg PO daily"
870997|NCT01175031|B1|Baseline|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
870998|NCT01175031|P1|Participant Flow|Sleep Apnea|Individuals with Obstructive Sleep Apnea (OSA); Complex Sleep Apnea (CompSAS) and central apnea index (CAI), or the PSG during PAP treatment had a central apnea index ≥ 5 events/h after obstructive apneas resolved.
870999|NCT01175031|O1|Outcome|Device-Detected Clear Airway Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
871000|NCT01175031|O1|Outcome|Device-Detected Obstructive Airway Apneas|Of the device-detected obstructive airway apneas a comparison was done of manually scored verses device detected.
871001|NCT01175031|O1|Outcome|Device-Detected Apneas|Device-detected apneas were classified as either Clear Airway or Obstructed Airway.
871002|NCT01175031|O2|Outcome|Manually Scored Polysomnography (PSG)|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
871003|NCT01175031|O1|Outcome|REMstar Auto With A-Flex|"Manipulation of positive airway pressure (PAP) will occur throughout the night to induce breaking events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced, and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. Events will be measured with REMstar Auto with A-Flex and Manually Scored Polysomnography (PSG).~Manipulation of Positive Airway Pressure (PAP): Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night. It will be measure by the REMstar Auto with A-Flex and manually scored PSG."
871004|NCT01175031|E1|Reported Event|Subjects With Sleep Apnea|Subjects aged 21 thru 80 with a diagnosis of CompSAS or OSA and able to undergo a full-night in the sleep laboratory.
871005|NCT01175018|B3|Baseline|Total|Total of all reporting groups
871006|NCT01175018|B2|Baseline|Placebo|0.67 ml of NaCl 0.9% solution
871007|NCT01175018|B1|Baseline|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871008|NCT01175018|P2|Participant Flow|Placebo|0.67 ml of sodium chloride (NaCl) 0.9% solution
871009|NCT01175018|P1|Participant Flow|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871010|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871011|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871012|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871013|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871014|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871015|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871016|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871017|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871018|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871019|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871020|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871021|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871022|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871023|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871024|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871025|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871026|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871027|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871028|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871029|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871030|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871031|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871032|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871033|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871034|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871035|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871036|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871037|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871038|NCT01175018|O2|Outcome|Placebo|"0.67 ml of NaCl 0.9% solution~Placebo: 0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days"
871039|NCT01175018|O1|Outcome|Anakinra|"Anakinra 100 mg injectable subcutaneously daily~Anakinra: Anakinra 100 mg s.c. daily for 14 days"
871040|NCT01175018|O2|Outcome|Placebo|0.67 ml of NaCl 0.9% solution
871041|NCT01175018|O1|Outcome|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871042|NCT01175018|E2|Reported Event|Placebo|0.67 ml of NaCl 0.9% solution
871043|NCT01175018|E1|Reported Event|Anakinra|Anakinra 100 mg injectable subcutaneously daily
871044|NCT01175005|B1|Baseline|Fever and a Central Venous Catheter|
871055|NCT01174576|P1|Participant Flow|Caffeinated Coffee/Decaffeinated Coffee/Water|"200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight or instant decaffeinated coffee or water. All participants received all interventions without exception in a random order.~Three combinations of treatment sequences were used:~Caffeinated coffee, then decaffeinated coffee, then water~Decaffeinated coffee first, then water, then caffeinated coffee~Water first, then caffeinated coffee, then decaffeinated coffee.~Each treatment was separated by the other by at least one week interval.~The first volunteer entered the study received the first combination, the second volunteer the second combiation, the third volunteer the third combination, the forth volunteer the first combination of treatments, etc."
871056|NCT01174576|O3|Outcome|Water|200 mL
871057|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871058|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871059|NCT01174576|O3|Outcome|Water|200 mL
871060|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871061|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871062|NCT01174576|O3|Outcome|Water|200 mL
871063|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871064|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871065|NCT01174576|O3|Outcome|Water|200 ml water
871066|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
871067|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
871068|NCT01174576|O3|Outcome|Water|200 mL
871069|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871070|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/ kg body weight
871071|NCT01174576|O3|Outcome|Water|200 ml water
871072|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 ml instant decaffeinated coffee
871073|NCT01174576|O1|Outcome|Caffeinated Coffee|200 ml instant caffeinated coffee with 3 mg caffeine/kg body weight
871074|NCT01174576|O3|Outcome|Water|200 mL
871075|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871076|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871077|NCT01174576|O3|Outcome|Water|200 mL
871078|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeineated coffee
871079|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871080|NCT01174576|O3|Outcome|Water|200 mL
871081|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871082|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871083|NCT01174576|O3|Outcome|Water|200 mL
871084|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871085|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871086|NCT01174576|O3|Outcome|Water|200 mL
871087|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871088|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871089|NCT01174576|O3|Outcome|Water|200 mL
871090|NCT01174576|O2|Outcome|Decaffeinated Coffee|200 mL, same amount as caffeinated coffee
871091|NCT01174576|O1|Outcome|Caffeinated Coffee|200 mL, 3 mg caffeine/kg body weight
871092|NCT01174576|E3|Reported Event|Water|200 mL
871093|NCT01174576|E2|Reported Event|Decaffeinated Coffee|200 mL decaffeinated coffee, same amount as caffeinated coffee
871094|NCT01174576|E1|Reported Event|Caffeinated Coffee|200 mL, coffee containing 3 mg caffeine/kg body weight
871095|NCT01174550|B3|Baseline|Total|Total of all reporting groups
871096|NCT01174550|B2|Baseline|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871097|NCT01174550|B1|Baseline|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871098|NCT01174550|P2|Participant Flow|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871099|NCT01174550|P1|Participant Flow|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871100|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871101|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871102|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871103|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871104|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871105|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871183|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871106|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871107|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871108|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871109|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871110|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871111|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871112|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871113|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871114|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871115|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871116|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871117|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871118|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871119|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871120|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871121|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871122|NCT01174550|O2|Outcome|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871123|NCT01174550|O1|Outcome|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871124|NCT01174550|E2|Reported Event|Anatomic Diagnostic Test|"Coronary Angiography~Coronary Angiography: Use of standard equipment for usual-care testing"
871125|NCT01174550|E1|Reported Event|Functional Diagnostic Tests|"Stress Echocardiogram Nuclear Stress Test Exercise Electrocardiogram~Stress Echocardiogram: Use of standard equipment for usual-care testing~Nuclear Stress Test: Use of standard equipment for usual-care testing~Exercise Electrocardiogram: Use of standard equipment for usual-care testing"
871126|NCT01174459|B1|Baseline|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
871127|NCT01174459|P1|Participant Flow|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
871128|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
871129|NCT01174459|O1|Outcome|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
871130|NCT01174459|E1|Reported Event|Patient With Restless Legs Syndrome|Pramipexole immediate release tablets, oral administration, 0.125 mg/day to maximum 0.75 mg/day
871131|NCT01174446|B1|Baseline|All Study Participants Who Received Study Drug|"BAX326 : -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
871132|NCT01174446|P4|Participant Flow|Study Part 2 Only: BAX326 On-Demand|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
871133|NCT01174446|P3|Participant Flow|Study Part 2 Only: BAX326 Prophylaxis|-Participants were only in Study Part 2 (i.e., did not participate in Study Parts 1 and 3)
871134|NCT01174446|P2|Participant Flow|PK (BeneFIX Then BAX326) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BeneFIX (75 ± 5 IU/kg) then BAX326 (75 ± 5 IU/kg).~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
871184|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871185|NCT01174446|O5|Outcome|On-Demand: End of Study|
871309|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
871135|NCT01174446|P1|Participant Flow|PK (BAX326 Then BeneFIX) Then Prophylaxis Then PK BAX326 Only|"Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 (75 ± 5 IU/kg) then BeneFIX (75 ± 5 IU/kg).~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 (75 ± 5 IU/kg) only and same study participants as Study Part 1"
871136|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871137|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871138|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871139|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871140|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871141|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871142|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871143|NCT01174446|O2|Outcome|On-Demand|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871144|NCT01174446|O1|Outcome|Prophylaxis|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871145|NCT01174446|O3|Outcome|Change From Baseline|
871146|NCT01174446|O2|Outcome|End of Study|
871147|NCT01174446|O1|Outcome|Part 1 or Part 2, Exposure Day 1 (Baseline)|
871148|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871149|NCT01174446|O5|Outcome|On-Demand: End of Study|
871150|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871151|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871152|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871153|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871154|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871155|NCT01174446|O5|Outcome|On-Demand: End of Study|
871213|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871156|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871157|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871158|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871159|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871160|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871161|NCT01174446|O5|Outcome|On-Demand: End of Study|
871162|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871163|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871164|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871165|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871166|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871167|NCT01174446|O5|Outcome|On-Demand: End of Study|
871168|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871169|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871170|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871171|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871172|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871173|NCT01174446|O5|Outcome|On-Demand: End of Study|
871174|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871175|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871176|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871177|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871178|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871179|NCT01174446|O5|Outcome|On-Demand: End of Study|
871180|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day (ED) 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871181|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871182|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871186|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871187|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871188|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871189|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871190|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871191|NCT01174446|O5|Outcome|On-Demand: End of Study|
871192|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871193|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871194|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871195|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871196|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871197|NCT01174446|O5|Outcome|On-Demand: End of Study|
871198|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871199|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871200|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871201|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871202|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871203|NCT01174446|O5|Outcome|On-Demand: End of Study|
871204|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871205|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871206|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871207|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871208|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871209|NCT01174446|O5|Outcome|On-Demand: End of Study|
871210|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871211|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871212|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871216|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871217|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871218|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871219|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871220|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871221|NCT01174446|O5|Outcome|On-Demand: End of Study|
871222|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871223|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871224|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871225|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871226|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871227|NCT01174446|O5|Outcome|On-Demand: End of Study|
871228|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871229|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871230|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871231|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871232|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871233|NCT01174446|O5|Outcome|On-Demand: End of Study|
871234|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871235|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871236|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871237|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871238|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871239|NCT01174446|O5|Outcome|On-Demand: End of Study|
871240|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871241|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871242|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871243|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871244|NCT01174446|O6|Outcome|On-Demand: Change From Baseline|
871245|NCT01174446|O5|Outcome|On-Demand: End of Study|
871246|NCT01174446|O4|Outcome|On-Demand: Part 1 or Part 2, Exposure Day 1 (Baseline)|"On-Demand Dosing and Frequency (Guidance):~Early hemarthrosis, muscle bleed, oral bleed= FIX level required(%) 20-40 IU/dL. Repeat every 24 hours. Duration: at least 1 day, until bleeding episode as indicated by pain is resolved or healing is achieved~More extensive hemarthrosis, muscle bleed, hematoma= FIX level required(%) 30-60 IU/dL. Repeat infusion every 24 hours for 3-4 days or more until pain and acute disability are resolved~Life threatening hemorrhages= FIX level required(%) 60-100 IU/dL. Repeat infusion every 8-24 hours until threat resolves~Required dose calculated using IR determined of first 16 participants who completed Part 1 according to:~Body weight (kg) x desired FIX rise (%) (IU/dL) x {reciprocal of observed recovery}~Given an anticipated recovery of 0.8 [IU/dl]/[IU/kg], required units calculated by:~Body weight (kg) x desired FIX rise (%or (IU/dL) x 1.3 IU/kg~Amount administered & frequency should be oriented to individual clinical effectiveness"
871247|NCT01174446|O3|Outcome|Prophylaxis: Change From Baseline|
871248|NCT01174446|O2|Outcome|Prophylaxis: End of Study|
871249|NCT01174446|O1|Outcome|Prophylaxis: Part 1 or Part 2, Exposure Day 1 (Baseline)|Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.
871250|NCT01174446|O2|Outcome|Participants With AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
871251|NCT01174446|O1|Outcome|Participants With AEs - Not Related|
871252|NCT01174446|O2|Outcome|AEs - Related|"Probable, possible, or unknown causality assessment of an AE will be counted as related."
871253|NCT01174446|O1|Outcome|AEs - Not Related|
871254|NCT01174446|O1|Outcome|All Study Participants|
871255|NCT01174446|O1|Outcome|All Study Participants|
871256|NCT01174446|O1|Outcome|All Study Participants|
871257|NCT01174446|O1|Outcome|All Study Participants|
871258|NCT01174446|O1|Outcome|All Study Participants|
871259|NCT01174446|O1|Outcome|All Study Participants|
871260|NCT01174446|O1|Outcome|All Study Participants|
871261|NCT01174446|O1|Outcome|All Study Participants|
871262|NCT01174446|O1|Outcome|All Study Participants|
871263|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
871264|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
871265|NCT01174446|O2|Outcome|On-Demand|Study Part 2 Only
871266|NCT01174446|O1|Outcome|Prophylaxis|Study Part 2 Only
871267|NCT01174446|O2|Outcome|Bleeding Treatment|Includes all participants who received any infusions for bleeding treatment in the Full Analysis Set. (ie includes all On-demand arm (N=14) and 33 participants from the prophylaxis arm who experienced a bleeding episode)
871268|NCT01174446|O1|Outcome|Prophylactic Treatment|
871269|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
871270|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
871271|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
871272|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
871273|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
871274|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
871275|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
871276|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
871277|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
871278|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
871279|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
871280|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
871281|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
871282|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
871283|NCT01174446|O7|Outcome|Bleeding Cause: Unknown|
871284|NCT01174446|O6|Outcome|Bleeding Cause: Injury|
871285|NCT01174446|O5|Outcome|Bleeding Cause: Spontaneous|
871286|NCT01174446|O4|Outcome|Bleeding Site: Non-Joint|
871287|NCT01174446|O3|Outcome|Bleeding Site: All Joint|
871288|NCT01174446|O2|Outcome|Bleeding Site: Non-Target Joint|
871289|NCT01174446|O1|Outcome|Bleeding Site: Target Joint|
871290|NCT01174446|O1|Outcome|BAX326 Prophylaxis|"Prophylactic treatment of 50 IU/kg BAX326 twice weekly. The dose range is 40-60 IU/kg and may be increased up to 75 IU/kg, if required.~Participants received a minimum of three months prophylactic treatment"
871291|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
871292|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
871293|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
871294|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
871295|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
871296|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
871297|NCT01174446|O4|Outcome|Study Completion or Termination Visit|
871298|NCT01174446|O3|Outcome|Part 2 or Part 3: Week 26|
871299|NCT01174446|O2|Outcome|Part 2: Week 13|
871300|NCT01174446|O1|Outcome|Part 2: Week 5|PK infusion with BAX326 at 75 ± 5 IU/kg
871301|NCT01174446|O5|Outcome|Study Completion or Termination Visit|
871302|NCT01174446|O4|Outcome|Part 2 or Part 3: Week 26|
871303|NCT01174446|O3|Outcome|Part 2: Week 13|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
871304|NCT01174446|O2|Outcome|Part 2: Week 5|PK infusion with BeneFIX at 75 ± 5 IU/kg
871305|NCT01174446|O1|Outcome|Part 1 or Part 2, ED 1|PK infusion with BAX326 at 75 ± 5 IU/kg
871306|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
871312|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
871313|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
871314|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
871315|NCT01174446|O3|Outcome|Study Part 3: BAX326|"PK infusion with BAX326 at 75 ± 5 IU/kg~Study Part 3 only evaluated BAX326 (ie BeneFIX was not evaluated in Study Part 3)"
871316|NCT01174446|O2|Outcome|Study Part 1: BeneFIX|PK infusion with BeneFIX at 75 ± 5 IU/kg
871317|NCT01174446|O1|Outcome|Study Part 1: BAX326|PK infusion with BAX326 at 75 ± 5 IU/kg
871318|NCT01174446|O2|Outcome|BeneFIX|
871319|NCT01174446|O1|Outcome|BAX326|
871320|NCT01174446|E1|Reported Event|BAX326|"BAX326: -Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
871321|NCT01174342|B1|Baseline|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
871322|NCT01174342|P1|Participant Flow|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
871323|NCT01174342|O1|Outcome|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery
871324|NCT01174342|E1|Reported Event|Healthy Pregnant Women|Healthy pregnant women candidates for vaginal delivery.
871325|NCT01174264|B4|Baseline|Total|Total of all reporting groups
871326|NCT01174264|B3|Baseline|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a low fat meal. Beginning 7 days later, patients receive vismodegib PO after eating a meal daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871327|NCT01174264|B2|Baseline|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose of vismodegib PO after eating a high fat meal. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871328|NCT01174264|B1|Baseline|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose of vismodegib PO on an empty stomach. Beginning 7 days later, patients receive vismodegib PO on an empty stomach daily on days 1-28.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871329|NCT01174264|P3|Participant Flow|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871330|NCT01174264|P2|Participant Flow|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871331|NCT01174264|P1|Participant Flow|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871332|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871333|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871334|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871335|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871336|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871337|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871338|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871339|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871340|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871341|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871342|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871343|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871344|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871374|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
871345|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871346|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871347|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871348|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871349|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871350|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871351|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871352|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871353|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871354|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871355|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871356|NCT01174264|O3|Outcome|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871357|NCT01174264|O2|Outcome|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871358|NCT01174264|O1|Outcome|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871359|NCT01174264|E3|Reported Event|Arm III (Vismodegib After Low Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a low fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871360|NCT01174264|E2|Reported Event|Arm II (Vismodegib After High Fat Meal)|"Patients receive a single dose (150 mg) of vismodegib PO after eating a high fat meal. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871361|NCT01174264|E1|Reported Event|Arm I (Vismodegib on Empty Stomach)|"Patients receive a single dose (150 mg) of vismodegib PO on an empty stomach. 7 days later, patients received 150 mg daily for 28 days.~Pharmacological Study: Correlative studies~Vismodegib: Given PO"
871362|NCT01174186|B3|Baseline|Total|Total of all reporting groups
871363|NCT01174186|B2|Baseline|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
871364|NCT01174186|B1|Baseline|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
871365|NCT01174186|P2|Participant Flow|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
871366|NCT01174186|P1|Participant Flow|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
871367|NCT01174186|O2|Outcome|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
871368|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
871369|NCT01174186|O1|Outcome|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
871370|NCT01174186|E2|Reported Event|Calprotectin Normal|"Spondylitis patients with active inflammation and normal calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week"
871371|NCT01174186|E1|Reported Event|Calprotetin Elevated|"Spondylitis patients with active inflammation and elevated calprotectin~Adalimumab: Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given"
871372|NCT01174173|B1|Baseline|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
871373|NCT01174173|P1|Participant Flow|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
871375|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
871376|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
871377|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
871378|NCT01174173|O1|Outcome|Ranolazine|"1000 mg PO BID~Ranolazine: ranolazine 1000 mg PO BID for 3 months"
871379|NCT01174173|E1|Reported Event|Ranolazine|Ranolazine: ranolazine 1000 mg PO BID for 3 months
871380|NCT01174160|B3|Baseline|Total|Total of all reporting groups
871381|NCT01174160|B2|Baseline|Placebo|"placebo~Up to two 10-min infusions of normal saline"
871382|NCT01174160|B1|Baseline|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
871383|NCT01174160|P2|Participant Flow|Placebo|"placebo~Up to two 10-min infusions of normal saline"
871384|NCT01174160|P1|Participant Flow|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
871385|NCT01174160|O2|Outcome|Placebo|"placebo~Up to two 10-min infusions of normal saline"
871386|NCT01174160|O1|Outcome|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
871387|NCT01174160|E2|Reported Event|Placebo|"placebo~Up to two 10-min infusions of normal saline"
871388|NCT01174160|E1|Reported Event|Vernakalant IV|"vernakalant hydrochloride~Up to two 10-min infusions of 3mg/kg +/- 2mg/kg vernakalant IV"
871389|NCT01174043|B1|Baseline|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
871390|NCT01174043|P1|Participant Flow|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
871391|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
871392|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
871393|NCT01174043|O1|Outcome|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
871394|NCT01174043|E1|Reported Event|Erlotinib|Erlotinib: Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
871395|NCT01174030|B6|Baseline|Total|Total of all reporting groups
871396|NCT01174030|B5|Baseline|Vehicle Gel BID|
871397|NCT01174030|B4|Baseline|Vehicle Gel QD|
871398|NCT01174030|B3|Baseline|CD07805/47 Gel 0.18% BID|
871399|NCT01174030|B2|Baseline|CD07805/47 Gel 0.18% QD|
871400|NCT01174030|B1|Baseline|CD07805/47 Gel 0.5% QD|
871401|NCT01174030|P5|Participant Flow|Vehicle Gel BID|Vehicle Gel Twice Daily
871402|NCT01174030|P4|Participant Flow|Vehicle Gel QD|Vehicle Gel Once Daily
871403|NCT01174030|P3|Participant Flow|CD07805/47 Gel 0.18% BID|CD07805/47 Gel 0.18% Twice Daily
871404|NCT01174030|P2|Participant Flow|CD07805/47 Gel 0.18% QD|CD07805/47 Gel 0.18% Once Daily
871405|NCT01174030|P1|Participant Flow|CD07805/47 Gel 0.5% QD|CD07805/47 Gel 0.5% Once Daily
871406|NCT01174030|O5|Outcome|Vehicle Gel BID|
871407|NCT01174030|O4|Outcome|Vehicle Gel QD|
871408|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
871409|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
871410|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
871411|NCT01174030|O5|Outcome|Vehicle Gel BID|
871412|NCT01174030|O4|Outcome|Vehicle Gel QD|
871413|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
871414|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
871415|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
871416|NCT01174030|O5|Outcome|Vehicle Gel BID|
871417|NCT01174030|O4|Outcome|Vehicle Gel QD|
871418|NCT01174030|O3|Outcome|CD07805/47 Gel 0.18% BID|
871419|NCT01174030|O2|Outcome|CD07805/47 Gel 0.18% QD|
871420|NCT01174030|O1|Outcome|CD07805/47 Gel 0.5% QD|
871421|NCT01174030|E5|Reported Event|Vehicle Gel BID|
871422|NCT01174030|E4|Reported Event|Vehicle Gel QD|
871423|NCT01174030|E3|Reported Event|CD07805/47 Gel 0.18% BID|
871424|NCT01174030|E2|Reported Event|CD07805/47 Gel 0.18% QD|
871425|NCT01174030|E1|Reported Event|CD07805/47 Gel 0.5% QD|
871426|NCT01174004|B3|Baseline|Total|Total of all reporting groups
871427|NCT01174004|B2|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
871428|NCT01174004|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
871429|NCT01174004|P2|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
871430|NCT01174004|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
871431|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
871432|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
871433|NCT01174004|O2|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
871434|NCT01174004|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
871435|NCT01174004|E2|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103), 40 mg, tablet, once daily by mouth, 6 weeks
871436|NCT01174004|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
871437|NCT01173874|B3|Baseline|Total|Total of all reporting groups
871438|NCT01173874|B2|Baseline|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
871452|NCT01173848|B3|Baseline|Total|Total of all reporting groups
871483|NCT01173653|E1|Reported Event|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
871484|NCT01173523|B3|Baseline|Total|Total of all reporting groups
871439|NCT01173874|B1|Baseline|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
871440|NCT01173874|P2|Participant Flow|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
871441|NCT01173874|P1|Participant Flow|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
871442|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
871443|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
871444|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
871445|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
871446|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
871447|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
871448|NCT01173874|O2|Outcome|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
871449|NCT01173874|O1|Outcome|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
871450|NCT01173874|E2|Reported Event|Cognitive Activity Control Group|This is a non-specific mental activity control condition, conducted two times per week for a total of 30 sessions.
871451|NCT01173874|E1|Reported Event|Cognitive Remediation|"Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.~Cognitive Remediation: Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving."
871453|NCT01173848|B2|Baseline|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
871454|NCT01173848|B1|Baseline|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
871455|NCT01173848|P2|Participant Flow|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
871456|NCT01173848|P1|Participant Flow|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
871457|NCT01173848|O2|Outcome|Vitamin D3|"Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
871458|NCT01173848|O1|Outcome|Vitamin D2|"Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months"
871459|NCT01173848|E1|Reported Event|Vitamin D2 and Vitamin D3|"Adverse Events were not logged by study arms.~Patients randomized to take vitamin D2~Ergocalciferol: 1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months~or~Patient's randomized to take Vitamin D3~Cholecalciferol: 1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months"
871460|NCT01173718|B1|Baseline|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871461|NCT01173718|P1|Participant Flow|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871462|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871463|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871464|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871465|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871466|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871467|NCT01173718|O1|Outcome|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft : Surgical implantation of the GORE® ACUSEAL Graft for Hemodialysis per the Investigator's standard of practice.
871468|NCT01173718|E1|Reported Event|GORE® ACUSEAL Vascular Graft|GORE® ACUSEAL Vascular Graft
871469|NCT01173679|B1|Baseline|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
871470|NCT01173679|P1|Participant Flow|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
871471|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
871472|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
871473|NCT01173679|O1|Outcome|Dasatinib, Rituximab, Fludarabine|"Single-arm, open-label~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
871474|NCT01173679|E1|Reported Event|Dasatinib, Rituximab, Fludarabine|"Single-arm~dasatinib: Taken orally once a day on days 1-14 of each 28-day cycle~Rituximab: Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).~fludarabine: Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)"
871475|NCT01173653|B3|Baseline|Total|Total of all reporting groups
871476|NCT01173653|B2|Baseline|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
871477|NCT01173653|B1|Baseline|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
871478|NCT01173653|P2|Participant Flow|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
871479|NCT01173653|P1|Participant Flow|Standard EM Smoking Cessation Info|Patients discharged from ER receive pamphlet re: smoking cessation
871480|NCT01173653|O2|Outcome|Intervention Arm|Enrollees put in contact with 1-800-QUIT-NOW line
871481|NCT01173653|O1|Outcome|Control Arm|No intervention given to this ED population of smokers
871482|NCT01173653|E2|Reported Event|Patients Contact 1-800-QUIT-NOW Before Leaving ED|Prior the patient leaving the ED, the PI will assist the patient with contacting 1-800-QUIT-NOW, who will help patient to quit smoking.
871485|NCT01173523|B2|Baseline|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
871486|NCT01173523|B1|Baseline|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
871487|NCT01173523|P2|Participant Flow|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
871488|NCT01173523|P1|Participant Flow|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
871489|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
871490|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
871491|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
871492|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
871493|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
871494|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
871495|NCT01173523|O2|Outcome|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
871496|NCT01173523|O1|Outcome|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
871497|NCT01173523|E2|Reported Event|Cohort B: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort B participants had not responded or had relapsed </= 60 days from the completion of initial chemotherapy.
871498|NCT01173523|E1|Reported Event|Cohort A: STA-9090|Once weekly IV dosing of STA-9090 200mg/m2 was given weeks 1, 2, and 3 of a 4-week cycle. Participants received treatment until evidence of progressive disease or unacceptable toxicity. Participants were stratified at baseline into 2 distinct prognostic groups. Cohort A participants had relapsed > 60 days following initial chemotherapy completion.
871499|NCT01173471|B5|Baseline|Total|Total of all reporting groups
871500|NCT01173471|B4|Baseline|AZD4017 400 mg BID|AZD4017 400 mg twice daily
871501|NCT01173471|B3|Baseline|Placebo BID|Placebo twice daily
871502|NCT01173471|B2|Baseline|AZD4017 200 mg OD|AZD4017 200 mg once daily
871503|NCT01173471|B1|Baseline|Placebo OD|Placebo once daily
871504|NCT01173471|P4|Participant Flow|AZD4017 400 mg BID|AZD4017 400 mg twice daily
871505|NCT01173471|P3|Participant Flow|Placebo BID|Placebo twice daily
871506|NCT01173471|P2|Participant Flow|AZD4017 200 mg OD|AZD4017 200 mg once daily
871507|NCT01173471|P1|Participant Flow|Placebo OD|Placebo once daily
871508|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
871509|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
871510|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
871511|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
871512|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
871513|NCT01173471|O3|Outcome|Placebo BID|Placebo twice daily
871514|NCT01173471|O2|Outcome|AZD4017 200 mg OD|AZD4017 200 mg once daily
871515|NCT01173471|O1|Outcome|Placebo OD|Placebo once daily
871516|NCT01173471|O4|Outcome|AZD4017 400 mg BID|AZD4017 400 mg twice daily
871520|NCT01173471|E4|Reported Event|AZD4017 400 mg BID|AZD4017 400 mg twice daily
871521|NCT01173471|E3|Reported Event|Placebo BID|Placebo twice daily
871522|NCT01173471|E2|Reported Event|AZD4017 200 mg OD|AZD4017 200 mg once daily
871523|NCT01173471|E1|Reported Event|Placebo OD|Placebo once daily
871524|NCT01173211|B7|Baseline|Total|Total of all reporting groups
871525|NCT01173211|B6|Baseline|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871526|NCT01173211|B5|Baseline|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871527|NCT01173211|B4|Baseline|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871528|NCT01173211|B3|Baseline|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871529|NCT01173211|B2|Baseline|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871530|NCT01173211|B1|Baseline|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871531|NCT01173211|P6|Participant Flow|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871532|NCT01173211|P5|Participant Flow|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871533|NCT01173211|P4|Participant Flow|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871534|NCT01173211|P3|Participant Flow|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871535|NCT01173211|P2|Participant Flow|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871536|NCT01173211|P1|Participant Flow|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871537|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871538|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871539|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871540|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871541|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871542|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871543|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871544|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871545|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871546|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871547|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871548|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871549|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871550|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871551|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871552|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871553|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871554|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871555|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871556|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871557|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871558|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871559|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871560|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871561|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871562|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871563|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871564|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871565|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871566|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871567|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871568|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871569|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871570|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871571|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871572|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871573|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871574|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871575|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871576|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871577|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871578|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871579|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871580|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871581|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871582|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871746|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871583|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871584|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871585|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871586|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871587|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871588|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871589|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871590|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871591|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871592|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871593|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871594|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871595|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871596|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871597|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871598|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871599|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871600|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871601|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871602|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871603|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871604|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871605|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871606|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871607|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871608|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871609|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871610|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871611|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871612|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871613|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871614|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871615|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871616|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871617|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871618|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871619|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871620|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871621|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871622|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871623|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871624|NCT01173211|O6|Outcome|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871625|NCT01173211|O5|Outcome|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871626|NCT01173211|O4|Outcome|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871627|NCT01173211|O3|Outcome|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871628|NCT01173211|O2|Outcome|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871629|NCT01173211|O1|Outcome|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871630|NCT01173211|E6|Reported Event|Fluzone (Sanofi Pasteur) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871631|NCT01173211|E5|Reported Event|Fluarix (GSK) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871632|NCT01173211|E4|Reported Event|Agriflu (Novartis) in Non-pregnant Participants|Non-pregnant participants received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871633|NCT01173211|E3|Reported Event|Fluzone (Sanofi Pasteur) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluzone (manufacturer sanofi pasteur), 45 mcg total antigen per dose
871634|NCT01173211|E2|Reported Event|Fluarix (GSK) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Fluarix (manufacturer GSK), 45 mcg total antigen per dose
871635|NCT01173211|E1|Reported Event|Agriflu (Novartis) in Pregnant Participants|Participants in their second or third trimester of pregnancy received a single intramuscular injection of Agriflu (manufacturer Novartis), 45 mcg total antigen per dose
871636|NCT01173120|B1|Baseline|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871637|NCT01173120|P1|Participant Flow|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871638|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871639|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
892120|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
871640|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871641|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871642|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871643|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871644|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871645|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871646|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871647|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871648|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous abatacept via the ACP for the duration of the substudy. Abatacept was administered subcutaneously using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a pre-filled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871649|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871650|NCT01173120|O1|Outcome|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of SC abatacept via the ACP for the duration of the substudy. Abatacept was administered using the ACP by the participant or caregiver on Substudy SC on Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871651|NCT01173120|E1|Reported Event|Abatacept Combination Product (ACP)|Participants from the long-term period of the IM101-174 main study who enrolled in the ACP substudy switched to administration of subcutaneous (SC) abatacept via the ACP for the duration of the substudy. Abatacept was administered SC using the ACP by the participant or caregiver on Substudy Day 1 and at weekly intervals thereafter. The ACP was a prefilled liquid product device delivering 125 mg abatacept/device (125 mg/mL).
871652|NCT01173055|B3|Baseline|Total|Total of all reporting groups
871653|NCT01173055|B2|Baseline|Placebo First, Then Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871654|NCT01173055|B1|Baseline|Milnacipran First, Then Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871655|NCT01173055|P2|Participant Flow|Placebo First, Then Milnacipran|"Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo First, Then Milnacipran: Period 1 (Day 1-49); Placebo matching study treatment was administered beginning Period 1 (Day 1-49) and a 14 day washout period. Then, Milnacipran Period 2 (Day 64-112); Milnacipran 12.5mg Day 62; 12.5mg twice daily (BID) Day 65 to 66; 25mg BID Day 67 to 70; 50mg BID Day 71-77; 100mg BID Day 78-105 followed by taper Day 106-112."
871656|NCT01173055|P1|Participant Flow|Milnacipran First, Then Placebo|"Milnacipran then placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Milnacipran First, Then Placebo: Period 1 (Day 1-49); Milnacipran 12.5mg by mouth (PO) Day 1; 12.5mg twice daily (BID) Day 2 to 3; 25mg BID Day 4 to 7; 50mg BID Day 8-14; 100mg BID Day 15-42 followed by taper Day 43-49 and a 14 day washout period. Then, placebo matching study treatment in similar pattern to Period 1 was administered beginning Period 2 (Day 64-112)."
871657|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871658|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871659|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871660|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871661|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871662|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871663|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871664|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871665|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871666|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871667|NCT01173055|O2|Outcome|Placebo|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~Placebo, then milnacipran: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871668|NCT01173055|O1|Outcome|Milnacipran|"Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.~milnacipran, then placebo: Milnacipran and placebo will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day."
871669|NCT01173055|E2|Reported Event|Placebo|Placebo was given orally twice daily in tablet form at different times during the course of the study.
871670|NCT01173055|E1|Reported Event|Milnacipran|Milnacipran was given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
871671|NCT01173029|B3|Baseline|Total|Total of all reporting groups
871672|NCT01173029|B2|Baseline|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871673|NCT01173029|B1|Baseline|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871747|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871674|NCT01173029|P2|Participant Flow|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871675|NCT01173029|P1|Participant Flow|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871676|NCT01173029|O9|Outcome|Polygenic Score: Eight|Sum of the weights for analyzing polymorphisms equal to eight.
871677|NCT01173029|O8|Outcome|Polygenic Score: Seven|Sum of the weights for analyzing polymorphisms equal to seven.
871678|NCT01173029|O7|Outcome|Polygenic Score: Six|Sum of the weights for analyzing polymorphisms equal to six.
871679|NCT01173029|O6|Outcome|Polygenic Score: Five|Sum of the weights for analyzing polymorphisms equal to five.
871680|NCT01173029|O5|Outcome|Polygenic Score: Four|Sum of the weights for analyzing polymorphisms equal to four.
871681|NCT01173029|O4|Outcome|Polygenic Score: Three|Sum of the weights for analyzing polymorphisms equal to three.
871682|NCT01173029|O3|Outcome|Polygenic Score: Two|Sum of the weights for analyzing polymorphisms equal to two.
871683|NCT01173029|O2|Outcome|Polygenic Score: One|Sum of the weights for analyzing polymorphisms equal to one.
871684|NCT01173029|O1|Outcome|Polygenic Score: Zero|Sum of the weights for analyzing polymorphisms equal to zero.
871685|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871686|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871687|NCT01173029|O2|Outcome|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871688|NCT01173029|O1|Outcome|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871689|NCT01173029|E2|Reported Event|Pseudo-resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure <130 mmHg and mean 24h diastolic pressure <80mmHg) by non-investigation specialized hypertensive unit care, with appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871690|NCT01173029|E1|Reported Event|Resistant Arterial Hypertension|Subjects with systemic arterial hypertension in whom arterial pressure control was not achieved (24h ambulatory pressure monitoring: mean 24h systolic pressure >/=130 mmHg and mean 24h diastolic pressure >/=80mmHg) by non-investigation specialized hypertensive unit care, in spite of appropriate drug treatment regimen with three or more anti-hypertensive drugs including a diuretic.
871691|NCT01172938|B4|Baseline|Total|Total of all reporting groups
871692|NCT01172938|B3|Baseline|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871693|NCT01172938|B2|Baseline|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871694|NCT01172938|B1|Baseline|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871695|NCT01172938|P7|Participant Flow|Placebo / Apremilast 30 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 to receive 30 mg apremilast for up to 4.5 years.
871696|NCT01172938|P6|Participant Flow|Placebo / Apremilast 30 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 30 mg apremilast for up to 4.5 years.
871697|NCT01172938|P5|Participant Flow|Placebo / Apremilast 20 mg XO|Participants initially randomized to receive placebo twice daily who were re-randomized at Week 24 (XO) to receive 20 mg apremilast for up to 4.5 years.
871698|NCT01172938|P4|Participant Flow|Placebo / Apremilast 20 mg EE|Participants initially randomized to receive placebo twice daily who were re-randomized due to early escape (EE) at Week 16 to receive 20 mg apremilast for up to 4.5 years.
871699|NCT01172938|P3|Participant Flow|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 28-week placebo-controlled phase and continued to receive 30 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
871700|NCT01172938|P2|Participant Flow|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily in the 28-week placebo-controlled phase and continued to receive 20 mg apremilast tablets twice daily for up to 4.5 years in the active treatment / long-term safety phase.
871701|NCT01172938|P1|Participant Flow|Placebo|Participants initially randomized to receive placebo tablets twice daily in the 24-week placebo-controlled phase. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either 20 mg or 30 mg apremilast twice daily (early escape).
871702|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871703|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871704|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871705|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871706|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871707|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871708|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871709|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871710|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871711|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871712|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871713|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871714|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871715|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871716|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871717|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871718|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871719|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871720|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871721|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871722|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871723|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871724|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871725|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871726|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871727|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871728|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871729|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871730|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871731|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871732|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871733|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871734|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871735|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871736|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871737|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871738|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871739|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871740|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871741|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871742|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871743|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871744|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871745|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871748|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871749|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871750|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871751|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871752|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871753|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871754|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871755|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871756|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871757|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871758|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871759|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871760|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871761|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871762|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871763|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871764|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871765|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871766|NCT01172938|O4|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871767|NCT01172938|O3|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871768|NCT01172938|O2|Outcome|Placebo / Apremilast 30 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 30 mg apremilast twice daily.
871769|NCT01172938|O1|Outcome|Placebo / Apremilast 20 mg|Participants who received placebo twice daily up to Week 16 or Week 24 and were then re-randomized to receive 20 mg apremilast twice daily.
871770|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871771|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871772|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871773|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871774|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871775|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871776|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871777|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871778|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871779|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871780|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871781|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871782|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871783|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871784|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871785|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871786|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871787|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871788|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871789|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871790|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871791|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871792|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871793|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871794|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871795|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871796|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871797|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871798|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871799|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871800|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871801|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871802|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871803|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871804|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871805|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871806|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871807|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871808|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871809|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871810|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871811|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871812|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871813|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871814|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871815|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871816|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871817|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871818|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871819|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871820|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871821|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871822|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871823|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871824|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871825|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871826|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871827|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871828|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871829|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871830|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871831|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
892121|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
871832|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871833|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871834|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871835|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871836|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871837|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871838|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871839|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871840|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871841|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871842|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871843|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871844|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871845|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871846|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871847|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871848|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871849|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871850|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871851|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871852|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871853|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871854|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871855|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871856|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871857|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871858|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871859|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871860|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871861|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871862|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871863|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871864|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871865|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily. Participants who did not have at least 20% improvement in swollen and tender joint counts at Week 16 were re-randomized to either to 20 mg or 30 mg apremilast twice daily (early escape).
871866|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871867|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871868|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871869|NCT01172938|O3|Outcome|Apremilast 30 mg|Participants initially randomized to receive 30 mg apremilast tablets twice daily.
871870|NCT01172938|O2|Outcome|Apremilast 20 mg|Participants initially randomized to receive 20 mg apremilast tablets twice daily.
871871|NCT01172938|O1|Outcome|Placebo|Participants initially randomized to receive placebo tablets twice daily.
871872|NCT01172938|E5|Reported Event|Week 52: Apremilast 30 mg|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
871873|NCT01172938|E4|Reported Event|Week 52: Apremilast 20 mg|Participants who received 20 mg apremilast, regardless of when the apremilast exposure started (at Week 0, 16, or 24), up until Week 52.
871874|NCT01172938|E3|Reported Event|Week 24: Apremilast 30 mg|Participants randomized to receive 30 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
871875|NCT01172938|E2|Reported Event|Week 24: Apremilast 20 mg|Participants randomized to receive 20 mg apremilast tablets twice daily during the 24-week placebo-controlled phase.
871876|NCT01172938|E1|Reported Event|Week 24: Placebo|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 16 for participants who escaped early, and through Week 24 for all other participants.
871877|NCT01172873|B3|Baseline|Total|Total of all reporting groups
892122|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
871878|NCT01172873|B2|Baseline|E/RP Alone (no DCS Administration)|Five participants were enrolled in the second treatment arm as a comparison. The participants received 10 twice-weekly sessions of E/RP treatment alone.
871879|NCT01172873|B1|Baseline|D-cycloserine + E/RP|Participants in this treatment arm received 10 twice-weekly sessions of E/RP treatment and were administered D-Cycloserine (DCS) immediately after every treatment visit.
871880|NCT01172873|P2|Participant Flow|E/RP Alone (no DCS Administration)|The final 5 participants enrolled in the study were assigned to a second treatment arm, to compare E/RP alone to E/RP with D-Cycloserine. These participants received 10 twice-weekly sessions of E/RP without D-Cycloserine. DCS was not administered to this group during the active study period.
871881|NCT01172873|P1|Participant Flow|D-cycloserine + E/RP|The first 11 participants received 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
871882|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
871883|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
871884|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
871885|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
871886|NCT01172873|O2|Outcome|E/RP Alone (no DCS Administration)|Participants receiving 10 twice-weekly sessions of E/RP treatment alone. DCS was not administered to this group during the active study period.
871887|NCT01172873|O1|Outcome|D-cycloserine + E/RP|Treatment involved 10 twice-weekly 60-minute sessions of exposure and response prevention (E/RP) during the active study period. D-Cycloserine 50 mg was administered immediately after each therapy session.
871888|NCT01172873|E2|Reported Event|E/RP Alone (no DCS Administration)|Participants in this arm received twice-weekly 60 minute sessions of E/RP alone for a total of 10 sessions.
871889|NCT01172873|E1|Reported Event|D-cycloserine + E/RP|Participants in this arm receive 10 twice-weekly 60-minute sessions of Exposure and Response Prevention (E/RP) therapy and 50mg of D-Cycloserine immediately after each therapy session. D-Cycloserine is only administered on days in which therapy sessions are held.
871890|NCT01172847|B1|Baseline|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
871891|NCT01172847|P1|Participant Flow|Oseltamivir; Rimantadine; Oseltamivir + Rimantadine|Participants received treatments in 3 periods as: Oseltamivir 75 milligram [mg] (twice a day orally for 5 days), Rimantadine 100 mg (twice a day orally for 5 days), and Oseltamivir 75 mg + Rimantadine 100 mg (twice a day orally for 5 days) in a randomly determined sequence with a minimum 7-day wash out period between consecutive treatments periods.
871892|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871893|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
871894|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871895|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871896|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
871897|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871898|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871899|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
871900|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871901|NCT01172847|O3|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871902|NCT01172847|O2|Outcome|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
871903|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871904|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871905|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871906|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871907|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871908|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871909|NCT01172847|O1|Outcome|Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871910|NCT01172847|O2|Outcome|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871911|NCT01172847|O1|Outcome|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871912|NCT01172847|E3|Reported Event|Oseltamivir + Rimantadine|Participants received oseltamivir 75 mg + rimantadine 100 mg twice a day orally for 5 days.
871913|NCT01172847|E2|Reported Event|Rimantadine|Participants received rimantadine 100 mg twice a day orally for 5 days.
871914|NCT01172847|E1|Reported Event|Oseltamivir|Participants received oseltamivir 75 mg twice a day orally for 5 days.
871915|NCT01172821|B5|Baseline|Total|Total of all reporting groups
892123|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
871916|NCT01172821|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871917|NCT01172821|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871918|NCT01172821|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871919|NCT01172821|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871920|NCT01172821|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871921|NCT01172821|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871922|NCT01172821|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871923|NCT01172821|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871924|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871925|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871926|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871927|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871928|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871929|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871930|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871931|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871932|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871933|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871934|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871935|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871936|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871937|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871938|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871939|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871940|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871941|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871942|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871943|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871944|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871945|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871946|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871947|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871948|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871949|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871950|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871951|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871952|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871953|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871954|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871955|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871956|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871957|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871958|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871959|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871960|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871961|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871962|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871963|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871964|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871965|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871966|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871967|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871968|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871969|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871970|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871971|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871972|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871973|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871974|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871975|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871976|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871977|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871978|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871979|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871980|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871981|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871982|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871983|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871984|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871985|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871986|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871987|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871988|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871989|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871990|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871991|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871992|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871993|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871994|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871995|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871996|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
871997|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
871998|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
871999|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872000|NCT01172821|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872001|NCT01172821|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872002|NCT01172821|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872003|NCT01172821|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872004|NCT01172821|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872005|NCT01172821|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872006|NCT01172821|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872007|NCT01172821|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872008|NCT01172808|B5|Baseline|Total|Total of all reporting groups
872009|NCT01172808|B4|Baseline|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872010|NCT01172808|B3|Baseline|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872011|NCT01172808|B2|Baseline|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872012|NCT01172808|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872013|NCT01172808|P4|Participant Flow|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872014|NCT01172808|P3|Participant Flow|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872015|NCT01172808|P2|Participant Flow|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872016|NCT01172808|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872017|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872018|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872019|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872020|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872021|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872022|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872023|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872024|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872025|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872026|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872027|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872028|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872029|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872030|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872031|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872032|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872033|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872034|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872035|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872036|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872037|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872038|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872039|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872040|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872041|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872042|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872043|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872044|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872045|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872046|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872047|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872048|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872049|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872050|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872051|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872052|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872053|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872054|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872055|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872056|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872057|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872058|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872059|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872060|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872061|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872062|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872063|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872064|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872065|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872066|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872067|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872068|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872199|NCT01172184|E1|Reported Event|Patients With Either Chronic or Acute Mitral Regurgitation|
872069|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872070|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872071|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872072|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872073|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872074|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872075|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872076|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872077|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872078|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872079|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872080|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872081|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872082|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872083|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872084|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872085|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872086|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872087|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872088|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872089|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872090|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872091|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872092|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872093|NCT01172808|O4|Outcome|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872094|NCT01172808|O3|Outcome|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872095|NCT01172808|O2|Outcome|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872096|NCT01172808|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872097|NCT01172808|E4|Reported Event|Salmeterol|Salmeterol 50 mcg bid (morning and evening) delivered by the MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872098|NCT01172808|E3|Reported Event|Tio R5|Tiotropium 5 mcg qd (evening) delivered by the Respimat Inhaler.
872099|NCT01172808|E2|Reported Event|Tio R2.5|Tiotropium 2.5 microgram (mcg) qd (evening) delivered by the Respimat Inhaler.
872100|NCT01172808|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler resp. MDI (hydrofluoroalkane (HFA 134a) metered inhaler).
872101|NCT01172600|B3|Baseline|Total|Total of all reporting groups
872102|NCT01172600|B2|Baseline|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872103|NCT01172600|B1|Baseline|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872104|NCT01172600|P2|Participant Flow|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872105|NCT01172600|P1|Participant Flow|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872106|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872107|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872108|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872109|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872200|NCT01172145|B3|Baseline|Total|Total of all reporting groups
872201|NCT01172145|B2|Baseline|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872110|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872111|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872112|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872113|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872114|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872115|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872116|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872117|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872118|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872119|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872120|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872121|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872122|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872123|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872124|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872125|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872126|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872127|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872128|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872129|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872130|NCT01172600|O2|Outcome|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872131|NCT01172600|O1|Outcome|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872132|NCT01172600|E2|Reported Event|Oxygen|"Patients will receive inhaled oxygen along with the interventional block they are scheduled.~Oxygen: Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872133|NCT01172600|E1|Reported Event|Entonox|"Patients will receive inhaled Entonox along with the interventional block they are scheduled.~Entonox: Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery."
872134|NCT01172535|B1|Baseline|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavirr, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872135|NCT01172535|P1|Participant Flow|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872136|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872137|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872138|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872139|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872140|NCT01172535|O3|Outcome|Week 24|Participants bringing medication to be measured at study week 24
872141|NCT01172535|O2|Outcome|Week 12|Participants bringing medication to be measured at study week 12
872142|NCT01172535|O1|Outcome|Week 4|Participants bringing medication to be measured at study week 4
872143|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872144|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872145|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872146|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872147|NCT01172535|O1|Outcome|Lopinavir/Ritonavir|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872148|NCT01172535|E1|Reported Event|LPV/r|Participants receiving lopinavir/ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines, in addition to two nucleoside reverse transcriptase inhibitors (NRTIs) chosen by their doctors.
872149|NCT01172522|B3|Baseline|Total|Total of all reporting groups
872150|NCT01172522|B2|Baseline|Fexofenadine Left Side; Placebo Right Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Fexofenadine, placebo"
872151|NCT01172522|B1|Baseline|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison.~Placebo, fexofenadine"
872152|NCT01172522|P2|Participant Flow|Fexofenadine Left Side; Placebo Right Side|Subjects were randomized as to side of face treated with test article versus placebo
872153|NCT01172522|P1|Participant Flow|Fexofenadine Right Side; Placebo Left Side|"Topical treatment active versus placebo.~Double blind randomized placebo controlled split face intrasubject comparison. Participants were randomized to side of face with active drug versus side of face with control, but with each treatment going on concurrently."
872154|NCT01172522|O2|Outcome|Placebo|All participants that received placebo
872155|NCT01172522|O1|Outcome|Fexofenadine|All participants that received fexofenadine
872156|NCT01172522|E1|Reported Event|Split Face Intrasubject Comparison|"Topical treatment active versus placebo~Double blind randomized placebo controlled split face intrasubject comparison."
872157|NCT01172418|B3|Baseline|Total|Total of all reporting groups
872158|NCT01172418|B2|Baseline|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
872159|NCT01172418|B1|Baseline|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
872160|NCT01172418|P2|Participant Flow|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
872161|NCT01172418|P1|Participant Flow|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
872162|NCT01172418|O2|Outcome|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
872202|NCT01172145|B1|Baseline|Cholinesterase Inhibitor Only|participants who received placebo
872163|NCT01172418|O1|Outcome|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
872164|NCT01172418|E2|Reported Event|Thymoglobulin and Alemtuzumab|"Group II: A new steroid avoidance protocol in which 1 dose of 1 mg/kg of Thymoglobulin® is to be infused at surgery followed by 1 dose of alemtuzumab (Campath-1H) at 0.3 mg/kg within 24 hours. No further antibody therapy will be used.~Alemtuzumab: used in conjunction with Thymoglobulin as combined Induction."
872165|NCT01172418|E1|Reported Event|Thymoglobulin and Daclizumab|"Group I: Our standard steroid avoidance protocol, i.e., 3 daily doses of 1 mg/kg of Thymoglobulin®, the first to be infused at surgery, accompanied by 2 doses of anti-CD25 humanized monoclonal antibody, the first also to be given at surgery, and the second 2 weeks later. (controls)~Daclizumab: used in combination with Thymoglobulin as combined induction"
872166|NCT01172353|B3|Baseline|Total|Total of all reporting groups
872167|NCT01172353|B2|Baseline|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
872168|NCT01172353|B1|Baseline|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
872169|NCT01172353|P2|Participant Flow|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
872170|NCT01172353|P1|Participant Flow|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
872171|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
872172|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
872173|NCT01172353|O2|Outcome|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
872174|NCT01172353|O1|Outcome|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
872175|NCT01172353|E2|Reported Event|Saline|"hydration with saline 1ml/Kg/h for 6 hours~saline: hydration with saline 1ml/Kg/h for 6 hours"
872176|NCT01172353|E1|Reported Event|Sodium Bicarbonate|"hydration with sodium bicarbonate~sodium bicarbonate: hydration with sodium bicarbonate 1ml/Kg/h for 6 hours"
872177|NCT01172288|B3|Baseline|Total|Total of all reporting groups
872178|NCT01172288|B2|Baseline|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872179|NCT01172288|B1|Baseline|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872180|NCT01172288|P2|Participant Flow|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872181|NCT01172288|P1|Participant Flow|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872182|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872183|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872184|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872185|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872186|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872187|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872188|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872189|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872190|NCT01172288|O2|Outcome|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872191|NCT01172288|O1|Outcome|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872192|NCT01172288|E2|Reported Event|Placebo|Placebo: 1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
872193|NCT01172288|E1|Reported Event|N-Acetylcysteine|N-Acetylcysteine (NAC): 1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
872194|NCT01172184|B1|Baseline|Patients With Either Chronic or Acute Mitral Regurgitation|
872195|NCT01172184|P1|Participant Flow|Patients With Either Chronic or Acute Mitral Regurgitation|
872196|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
872197|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
872198|NCT01172184|O1|Outcome|Patients With Either Chronic or Acute Mitral Regurgitation|
872203|NCT01172145|P2|Participant Flow|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872204|NCT01172145|P1|Participant Flow|Cholinesterase Inhibitor Only|participants who received placebo
872205|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872206|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872207|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872208|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872209|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872210|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872211|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872212|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872213|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872214|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872215|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872216|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872217|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872218|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872219|NCT01172145|O2|Outcome|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872220|NCT01172145|O1|Outcome|Cholinesterase Inhibitor Only|participants who received placebo
872221|NCT01172145|E2|Reported Event|Cholinesterase Plus Modafinil|participants who received modafinil (200 mg per day)
872222|NCT01172145|E1|Reported Event|Cholinesterase Inhibitor Only|participants who received placebo
872223|NCT01171989|B4|Baseline|Total|Total of all reporting groups
872224|NCT01171989|B3|Baseline|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872225|NCT01171989|B2|Baseline|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872226|NCT01171989|B1|Baseline|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872227|NCT01171989|P3|Participant Flow|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872228|NCT01171989|P2|Participant Flow|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872229|NCT01171989|P1|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872230|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872231|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872232|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872314|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872233|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872234|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872235|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872236|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872237|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872238|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872239|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872240|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872241|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872242|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872243|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872244|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872245|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872246|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
892124|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
872247|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872248|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872249|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872250|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872251|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872252|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872253|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872254|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872255|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872256|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872257|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872258|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872259|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872260|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872408|NCT01171820|B2|Baseline|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872261|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872262|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872263|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872264|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872265|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872266|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872267|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872268|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872269|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872270|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872271|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872272|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872273|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872274|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872409|NCT01171820|B1|Baseline|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872275|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872276|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872277|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872278|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872279|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872280|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872281|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872282|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872283|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872284|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872285|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872286|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872287|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872288|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
892125|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
872289|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872290|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872291|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872292|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872293|NCT01171989|O3|Outcome|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872294|NCT01171989|O2|Outcome|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872295|NCT01171989|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872296|NCT01171989|E3|Reported Event|Infanrix Hexa/NeisVac-C + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with NeisVac-C® vaccine at Day 0 and 1 dose of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872297|NCT01171989|E2|Reported Event|Infanrix Hexa/Menjugate Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of Infanrix hexa™ vaccine and 2 doses of Menjugate® vaccine in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of Infanrix hexa™ vaccine co-administered with Menjugate® vaccine at Day 0. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872298|NCT01171989|E1|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female subjects between, and including, 12 to 18 months of age at the time of booster vaccination, who were primed with 3 doses of GSK2202083A and Synflorix™ vaccines in the primary study DTPa-HBV-IPV=HIB-MenC-TT-002 (112157), additionally received a booster dose of GSK2202083A vaccine at Day 0 and of Synflorix™ vaccine at Month 1. Both vaccines were administered intramuscularly in the anterolateral side of the thigh.
872299|NCT01171976|B4|Baseline|Total|Total of all reporting groups
872300|NCT01171976|B3|Baseline|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872301|NCT01171976|B2|Baseline|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872302|NCT01171976|B1|Baseline|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872303|NCT01171976|P3|Participant Flow|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872304|NCT01171976|P2|Participant Flow|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872305|NCT01171976|P1|Participant Flow|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872306|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872307|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872308|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872309|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872310|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872311|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872312|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872313|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872315|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872316|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872317|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872318|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872319|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872320|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872321|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872322|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872323|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872324|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872325|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872326|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872327|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872328|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872329|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872330|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872331|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872332|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872333|NCT01171976|O3|Outcome|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872334|NCT01171976|O2|Outcome|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872335|NCT01171976|O1|Outcome|TE Ranibizumad 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872336|NCT01171976|E3|Reported Event|PRN Ranibizumab 0.5 mg|Participants received ranibizumab intravitreal injection therapy as needed according to signs and symptoms of disease.
872337|NCT01171976|E2|Reported Event|TE Ranibizumab 0.5 mg Alone|Patients received an intravitreal injection ranibizumab
872338|NCT01171976|E1|Reported Event|TE Ranibizumab 0.5 mg and Laser|Patients received an injection ranibizumab and laser therapy.
872339|NCT01171963|B3|Baseline|Total|Total of all reporting groups
872340|NCT01171963|B2|Baseline|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872341|NCT01171963|B1|Baseline|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872342|NCT01171963|P2|Participant Flow|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872410|NCT01171820|P2|Participant Flow|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during percutaneous coronary intervention (PCI)
872411|NCT01171820|P1|Participant Flow|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872412|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872413|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872414|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872415|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
892126|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
872343|NCT01171963|P1|Participant Flow|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872344|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872345|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872346|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872347|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872348|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872349|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872416|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872417|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872418|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872419|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872420|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872421|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
892127|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
872350|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872351|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872352|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872353|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872354|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872355|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872356|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872422|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872423|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872424|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872425|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872426|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872427|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872428|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872357|NCT01171963|O1|Outcome|Overall Study Arm|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872358|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872359|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872360|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872361|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872362|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872363|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872429|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872430|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872431|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872432|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872433|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872434|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
892128|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
872364|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872365|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872366|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872367|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872368|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872369|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872370|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872435|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872436|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872437|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872438|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872439|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872440|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872441|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872371|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872372|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872373|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872374|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872375|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872376|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872377|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872442|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872443|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872444|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872445|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872446|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872447|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
892129|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
872378|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872379|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872380|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872381|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872382|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872383|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872384|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872448|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872449|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872450|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872451|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872452|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872453|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872454|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872385|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872386|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872387|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872388|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872389|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.Not Applicable
872390|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872391|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872455|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872456|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872457|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872458|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872459|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872460|NCT01171820|O2|Outcome|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872392|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872393|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872394|NCT01171963|O2|Outcome|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872395|NCT01171963|O1|Outcome|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872396|NCT01171963|E2|Reported Event|Placebo Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Placebo at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccine were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Placebo. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Placebo and the OPV vaccine were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872397|NCT01171963|E1|Reported Event|Rotarix Group|Subjects aged between and including 6 and 16 weeks at the time of first vaccination received 2 doses of Rotarix™ vaccine, liquid formulation, at Day 0 and at Month 1. As part of the routine childhood vaccination according to the Expanded Program of Immunization (EPI) recommendations in China, subjects in this group also received 3 doses of Infanrix™ vaccine and 3 doses of the oral poliovirus vaccine manufactured by the Institute of Medical Biology of the Chinese Academy of Medical Sciences (OPV). The Infanrix™ and the OPV vaccines were administered independently of (Sub-cohort 1) or concomitantly with (Sub-cohort 2) the Rotarix™ vaccine. When administered concomitantly, subjects received the 3 doses of Infanrix™ vaccine at Months 1, 2 and 3, and the 3 doses of the OPV vaccine at Day 0, Month 1 and Month 2. The Rotarix™ and OPV vaccines were administered orally; the Infanrix™ vaccine was administered intramuscularly in the left anterolateral thigh.
872398|NCT01171924|B3|Baseline|Total|Total of all reporting groups
872399|NCT01171924|B2|Baseline|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
872400|NCT01171924|B1|Baseline|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
872401|NCT01171924|P2|Participant Flow|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
872402|NCT01171924|P1|Participant Flow|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
872403|NCT01171924|O2|Outcome|Arm B: 3 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
872404|NCT01171924|O1|Outcome|Arm A: 5 Days/Week Schedule|CUDC-101: CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
872405|NCT01171924|E2|Reported Event|Arm B: 3 Days/Week|
872406|NCT01171924|E1|Reported Event|Arm A: 5 Days/Week|
872407|NCT01171820|B3|Baseline|Total|Total of all reporting groups
872461|NCT01171820|O1|Outcome|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872462|NCT01171820|E2|Reported Event|XIENCE V® EECSS|Patients receiving the XIENCE V® EECSS stent during PCI
872463|NCT01171820|E1|Reported Event|TAXUS® Liberté™|Patients receiving the TAXUS® Liberté™ stent during PCI
872464|NCT01171794|B3|Baseline|Total|Total of all reporting groups
872465|NCT01171794|B2|Baseline|Placebo|Visually identical placebo
872466|NCT01171794|B1|Baseline|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
872467|NCT01171794|P2|Participant Flow|Placebo|Visually identical placebo
872468|NCT01171794|P1|Participant Flow|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
872469|NCT01171794|O2|Outcome|Placebo|visually identical placebo
872470|NCT01171794|O1|Outcome|Ibuprofen|Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
872471|NCT01171794|O2|Outcome|Placebo|visually identical placebo
872472|NCT01171794|O1|Outcome|Ibuprofen|Ibuprofen: 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
872473|NCT01171794|E2|Reported Event|Placebo|visually identical placebo
872474|NCT01171794|E1|Reported Event|Ibuprofen|Ibuprofen : 3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
872475|NCT01171690|B3|Baseline|Total|Total of all reporting groups
872476|NCT01171690|B2|Baseline|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
872477|NCT01171690|B1|Baseline|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
872478|NCT01171690|P2|Participant Flow|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
872479|NCT01171690|P1|Participant Flow|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
872480|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
872481|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
872482|NCT01171690|O2|Outcome|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
872483|NCT01171690|O1|Outcome|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
872484|NCT01171690|E2|Reported Event|Control|These are patients with similar degree of hypocalcemia that were treated per standard of care for hypoparathyroidism and did not receive teriparatide. They were all hospitalized at the time of hypocalcemia and were matched by age and gender with the intervention group.
872485|NCT01171690|E1|Reported Event|Teriparatide|"The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.~There were no adverse events related to the use of teriparatide."
872486|NCT01171677|B3|Baseline|Total|Total of all reporting groups
872487|NCT01171677|B2|Baseline|Treatment as Usual|
872488|NCT01171677|B1|Baseline|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872489|NCT01171677|P2|Participant Flow|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872490|NCT01171677|P1|Participant Flow|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872712|NCT01170533|O2|Outcome|Omeprazole Staggered|Participants took omeprazole with clopidogrel staggered
872491|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872492|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872493|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872494|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872495|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872496|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872497|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872498|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872499|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
892130|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
872500|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872501|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872502|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872503|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872504|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872505|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872506|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872507|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872508|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872713|NCT01170533|O1|Outcome|Omeprazole Concomitant|Participants took omeprazole with clopidogrel concomitantly
872509|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872510|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872511|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872512|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872513|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872514|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872515|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872516|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872517|NCT01171677|O2|Outcome|Treatment as Usual|Odyssey House delivers a rich array of services which are typically embedded in Enhanced Therapeutic Community (ETC) settings. The ETC incorporates a highly structured, peer-driven social learning model supported by professional medical, psychiatric, vocational and educational services. Clients create a self-directed treatment plan with definable goals and outcomes and participate in structured group and individual counseling sessions with trained professional staff while living onsite for a period of six to twelve months. Clients attend onsite educational classes and/or participate in onsite job training through job-related tasks and functions within the facility. Regular seminars are conducted to teach life skills, including parenting, anger management, and relapse prevention with the goal of eventual successful reintegration into the community.
872734|NCT01170273|B3|Baseline|Total|Total of all reporting groups
872518|NCT01171677|O1|Outcome|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872519|NCT01171677|E2|Reported Event|Treatment As Usual|
872520|NCT01171677|E1|Reported Event|Intensati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
872521|NCT01171612|B1|Baseline|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
872522|NCT01171612|P1|Participant Flow|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
872523|NCT01171612|O3|Outcome|Complete Withdrawal|patients with aspirin oand/or clopidogrel, which stopped therapy > 5 days
872524|NCT01171612|O2|Outcome|Incomplete Withdrawal (Mantaining ASA, Clopidogrel Withdrawn)|Patients under dual antiplatelet therapy, wich maintain aspirin, and withdrawn clopidogrel 5 or more days
872525|NCT01171612|O1|Outcome|Not Withdrawal Antiplatelet Therapy|Patients wiht aspirin and/or clopidogrel withdrawal for 5 or more days
872526|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
872527|NCT01171612|O1|Outcome|Coronary Stent|Patients with coronary Bare Metal Stent (BMS) or Drug Eluting Stent (DES) undergoing noncardiac surgery
872528|NCT01171612|E1|Reported Event|Cardiac and Cerebrovascular Events|Adverse events registered independently related with antiplatelet therapy management
872529|NCT01171534|B3|Baseline|Total|Total of all reporting groups
872530|NCT01171534|B2|Baseline|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
872531|NCT01171534|B1|Baseline|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
872532|NCT01171534|P2|Participant Flow|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
872533|NCT01171534|P1|Participant Flow|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
872534|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
872535|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
872536|NCT01171534|O2|Outcome|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
872537|NCT01171534|O1|Outcome|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
872538|NCT01171534|E2|Reported Event|DermaClose Fasciotomy Closure|"Fasciotomy closure via DermaClose device~DermaClose Continuous External Tissue Expander: The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed."
872539|NCT01171534|E1|Reported Event|Vessel Loop Fasciotomy Closure|"Fasciotomy closure using vessel loops and staples.~Vessel loop: Vessel loops and staples for fasciotomy closure"
872540|NCT01171521|B1|Baseline|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
872541|NCT01171521|P1|Participant Flow|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
872542|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
872543|NCT01171521|O1|Outcome|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
872735|NCT01170273|B2|Baseline|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
872544|NCT01171521|E1|Reported Event|DermaClose Group|"DermaClose device applied to complex soft-tissue wound, with or without negative pressure wound therapy, and prospectively followed for primary and secondary outcomes for one year.~DermaClose external tissue expander: The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed."
872545|NCT01171183|B3|Baseline|Total|Total of all reporting groups
872546|NCT01171183|B2|Baseline|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
872547|NCT01171183|B1|Baseline|Placebo|Placebo: Placebo
872548|NCT01171183|P2|Participant Flow|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
872549|NCT01171183|P1|Participant Flow|Placebo|Placebo: Placebo
872550|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
872551|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
872552|NCT01171183|O2|Outcome|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
872553|NCT01171183|O1|Outcome|Placebo|Placebo: Placebo
872554|NCT01171183|E2|Reported Event|Carvedilol Controlled Release|"controlled release carvedilol (Coreg CR) at 80 mg/day in once daily dosing~controlled release carvedilol: carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper"
872555|NCT01171183|E1|Reported Event|Placebo|Placebo: Placebo
872556|NCT01171118|B1|Baseline|Physostigmine/Placebo|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuouslyCapsaicin : 0.075% topical cream applicationPlacebo:We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this.
872557|NCT01171118|P1|Participant Flow|Physostigmine vs. Placebo in Room Air vs. O2 During Sedation|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Physostigmine (PS) vs. Placebo were randomized by DAYS. Then, on each day, subjects were randomized to receive oxygen or room air first or second. But each subject went through BOTH days and both oxygen and room air on each day.~There were eight total possible sequences."
872558|NCT01171118|O4|Outcome|Placebo/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
872559|NCT01171118|O3|Outcome|Physostigmine/Room Air|"Each subject received the sedation protocol as described below:~Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Then, subjects were randomized to the specific order of each four arms. Subjects breathed room air and received placebo instead of physostigimine in this arm."
872560|NCT01171118|O2|Outcome|Placebo/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
872561|NCT01171118|O1|Outcome|Physostigmine/Oxygen|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application Subjects were breathing oxygen via nasal cannula at 2 liters/minute
872562|NCT01171118|E4|Reported Event|Room Air|Subjects were assessed for two separate one hour periods of time -- one hour while breathing room air
872563|NCT01171118|E3|Reported Event|Oxygen|Subjects were assessed for two separate one hour periods of time -- one hour while breathing oxygen via a nasal cannula at 2 liters/minute
872564|NCT01171118|E2|Reported Event|Placebo|We are attempting to demonstrate a decrease in the frequency and severity of sedation-induced respiratory arrhythmias (central and obstructive apneas) with pharmacological pre-treatment in this pilot project and then eventually to understand the mechanisms behind this decrease. The efficacy and mechanisms of these treatments, while evaluated during sleep in OSA patients, have not been systematically studied during sedation in either normal subjects or OSA patients. The agent to be assessed in this study is physostigmine versus placebo.
872793|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
872565|NCT01171118|E1|Reported Event|Physostigmine|Physostigmine (PS), a centrally-acting acetylcholinesterase inhibitor, is most commonly used by anesthesiologists in the post-anesthetic setting to reverse confusion caused by central anticholinergic medication effects. It has also been proposed as a treatment for sleep disordered breathing.We investigated whether PS was effective in decreasing the frequency of ventilatory arrhythmias (VA) produced during moderate sedation with midazolam and remifentanil in both room air (RA) and 2 l/m nasal O2. Midazolam : The sedation will be initated with a midazolam infusion with an effect-site target of 100 mg/ml intraventously Remifentanil : 0.3 mg/ml intravenously continuously Capsaicin : 0.075% topical cream application
872566|NCT01170962|B4|Baseline|Total|Total of all reporting groups
872567|NCT01170962|B3|Baseline|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872568|NCT01170962|B2|Baseline|Daclastavir (60mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872569|NCT01170962|B1|Baseline|Daclastavir (20mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872570|NCT01170962|P3|Participant Flow|Placebo: Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872571|NCT01170962|P2|Participant Flow|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872572|NCT01170962|P1|Participant Flow|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872573|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872574|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872575|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872576|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872577|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872578|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872579|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872580|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy.
872581|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872582|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872900|NCT01169753|E1|Reported Event|Placebo|Oral placebo every morning for 2 weeks.
872583|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872584|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872585|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872586|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872587|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872588|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872589|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872590|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872599|NCT01170962|O3|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872591|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872592|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872593|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872594|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily along with pegIFNα-2a solution for injection 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily up to 24 weeks. Participants continued to receive pegIFNα-2a and ribavirin, up to 48 weeks followed by a post treatment follow-up period of 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872595|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872596|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872597|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872598|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872600|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872601|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null and Partial Responders|Participants (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872602|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872603|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872604|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872605|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872606|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872607|NCT01170962|O5|Outcome|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872654|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872736|NCT01170273|B1|Baseline|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
872608|NCT01170962|O4|Outcome|Daclatasvir (60 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872609|NCT01170962|O3|Outcome|Daclatasvir (20 mg): Prior Partial Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872610|NCT01170962|O2|Outcome|Daclatasvir (60 mg): Prior Null Responders|Participants received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872611|NCT01170962|O1|Outcome|Daclatasvir (20 mg): Prior Null Responders|Participants received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872612|NCT01170962|E3|Reported Event|Placebo: Prior Partial Responders|Participants who were prior partial responders received placebo matched with daclatasvir tablets orally, once daily for 24 weeks. Participants received pegIFNα-2a 180 µg/0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for 48 weeks and followed post treatment for 24 weeks. Prior partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872613|NCT01170962|E2|Reported Event|Daclatasvir (60 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 60 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872614|NCT01170962|E1|Reported Event|Daclatasvir (20 mg): Prior Null and Partial Responders|Participant (prior null or partial responders) received daclatasvir tablets 20 mg orally once daily, pegylated-interferon alfa-2a (pegIFNα-2a) injection 180 µg/0.5 mL subcutaneously once weekly, ribavirin tablets 1000-1200 mg orally twice daily for 24 weeks. At Week 24, participants with a protocol defined response (PDR: HCV RNA <LOQ at Week 4, undetectable HCV RNA at Week 12) were randomized (1:1) to either a follow-up period of 48 weeks or received pegIFNα-2a and ribavirin for 24 weeks and then followed for 24 weeks. Participants with no PDR continued to receive pegIFNα-2a and ribavirin, for an additional 24 weeks and followed up for 24 weeks. Prior null responders: <1 log10 HCV RNA decrease from baseline at or after 4 weeks, or <2 log10 decrease from baseline in HCV RNA at or after Week 12 of IFN-based therapy. Prior Partial responders: >2 log10 decrease in HCV RNA from baseline at Week 12 of IFN-based therapy but detectable HCV RNA when therapy was discontinued.
872615|NCT01170949|B3|Baseline|Total|Total of all reporting groups
872616|NCT01170949|B2|Baseline|Placebo|
872617|NCT01170949|B1|Baseline|Miltefosine|
872618|NCT01170949|P2|Participant Flow|Placebo|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
872655|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872619|NCT01170949|P1|Participant Flow|Miltefosine|Week 1 – 50 mg miltefosine or placebo Week 2 – 100 mg miltefosine or placebo (1 capsule in the morning and one in the evening),if evidence of intolerability dose had to be reduced to 50 mg, those patients received 50 mg until the end of the treatment period Week 3 – 150 mg miltefosine or placebo (3 capsules, one in the morning, one at lunch and one in the evening) if evidence of intolerability dose had to be reduced to 100 mg, those patients received 100 mg until the end of the treatment period
872620|NCT01170949|O2|Outcome|Placebo|Placebo: Placebo
872621|NCT01170949|O1|Outcome|Miltefosine|Miltefosine: 50 or 100 or 150mg per day
872622|NCT01170949|E2|Reported Event|Placebo|
872623|NCT01170949|E1|Reported Event|Miltefosine|
872624|NCT01170884|B3|Baseline|Total|Total of all reporting groups
872625|NCT01170884|B2|Baseline|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
872626|NCT01170884|B1|Baseline|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
872627|NCT01170884|P2|Participant Flow|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
872628|NCT01170884|P1|Participant Flow|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
872629|NCT01170884|O2|Outcome|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
872630|NCT01170884|O1|Outcome|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
872631|NCT01170884|E2|Reported Event|Lumigan®|LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes
872632|NCT01170884|E1|Reported Event|Combigan® + Lumigan®|COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution)
872633|NCT01170754|B3|Baseline|Total|Total of all reporting groups
872634|NCT01170754|B2|Baseline|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872635|NCT01170754|B1|Baseline|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872636|NCT01170754|P2|Participant Flow|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872637|NCT01170754|P1|Participant Flow|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872638|NCT01170754|O2|Outcome|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872639|NCT01170754|O1|Outcome|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872640|NCT01170754|E2|Reported Event|Golytely 4 Liters|"Golytely 4 Liters~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872641|NCT01170754|E1|Reported Event|PEG-3350 and Gatorade|"255 miralax with 64 oz gatorade.~Golytely vs. Miralax plus gatorade: 4L of golytely vs. 255 grams of PEG-3350 mixed with 64 ounces gatorade for colonoscopy preparation."
872642|NCT01170663|B3|Baseline|Total|Total of all reporting groups
872643|NCT01170663|B2|Baseline|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872644|NCT01170663|B1|Baseline|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872645|NCT01170663|P2|Participant Flow|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872646|NCT01170663|P1|Participant Flow|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 milligrams/kilogram (mg/kg) of ramucirumab (IMC-1121B) was administered by intravenous (IV) infusion on Days 1 and 15 in combination with 80 milligrams/square meter (mg/m²) paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872647|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872648|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872649|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872650|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872651|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872652|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872653|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872708|NCT01170533|O6|Outcome|Clopidogrel Only (Pantoprazole Phase)|Participants took clopidogrel only
872656|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872657|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872658|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872659|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872660|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872661|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872662|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872663|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872664|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872665|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872666|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872667|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872668|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872669|NCT01170663|O2|Outcome|Placebo Plus Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² paclitaxel administered on Days 1, 8, and 15 of a 28-day cycle.
872670|NCT01170663|O1|Outcome|Ramucirumab (IMC-1211B) Plus Paclitaxel|8 mg/kg of ramucirumab (IMC-1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² paclitaxel administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872671|NCT01170663|E2|Reported Event|Placebo and Paclitaxel|Placebo was administered by IV infusion on Days 1 and 15, in combination with 80 mg/m² administered on Days 1, 8, and 15 of a 28-day cycle.
872672|NCT01170663|E1|Reported Event|Ramucirumab and Paclitaxel|8 mg/kg ramucirumab (IMC1121B) was administered by IV infusion on Days 1 and 15 in combination with 80 mg/m² administered by IV infusion on Days 1, 8, and 15 of a 28-day cycle.
872673|NCT01170598|B1|Baseline|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872674|NCT01170598|P1|Participant Flow|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872675|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872676|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872677|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872678|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872679|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872709|NCT01170533|O5|Outcome|Clopidogrel Only (Omeprazole Phase)|Participants took clopidogrel only
872710|NCT01170533|O4|Outcome|Pantoprazole Staggered|Participants took pantoprazole with clopidogrel staggered
872711|NCT01170533|O3|Outcome|Pantoprazole Concomitant|Participants took pantoprazole with clopidogrel concomitantly
872680|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872681|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872682|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872683|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872684|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872685|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872686|NCT01170598|O1|Outcome|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872687|NCT01170598|E1|Reported Event|Exercise|All study participants were part of the exercise group as this was a non-randomized study. Participants were approached 4-5 times per week to participate in supervised, individualized exercise sessions that incorporated a combination of aerobic, resistance and flexibility exercises. Exercise was light to moderate in intensity and each exercise session was 30-45 minutes in length.
872688|NCT01170546|B5|Baseline|Total|Total of all reporting groups
872689|NCT01170546|B4|Baseline|Control|Control group
872690|NCT01170546|B3|Baseline|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
872691|NCT01170546|B2|Baseline|SP (Squat Press)|plate-loaded squat press
872692|NCT01170546|B1|Baseline|KLCIR|plate-loaded kneeling leg curl with internal rotation
872693|NCT01170546|P4|Participant Flow|Control|Control group
872694|NCT01170546|P3|Participant Flow|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
872695|NCT01170546|P2|Participant Flow|SP (Squat Press)|plate-loaded squat press
872696|NCT01170546|P1|Participant Flow|KLCIR|plate-loaded kneeling leg curl with internal rotation
872697|NCT01170546|O4|Outcome|Control|Control group
872698|NCT01170546|O3|Outcome|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
872699|NCT01170546|O2|Outcome|SP (Squat Press)|plate-loaded squat press
872700|NCT01170546|O1|Outcome|KLCIR|plate-loaded kneeling leg curl with internal rotation
872701|NCT01170546|E4|Reported Event|Control|Control group
872702|NCT01170546|E3|Reported Event|KLC ( Kneeling Leg Curl)|plate-loaded kneeling leg curl
872703|NCT01170546|E2|Reported Event|SP (Squat Press)|plate-loaded squat press
872704|NCT01170546|E1|Reported Event|KLCIR|plate-loaded kneeling leg curl with internal rotation
872705|NCT01170533|B1|Baseline|All Study Participants|"This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).~The PPI could be omeprazole (first phase) or pantoprazole (second phase)."
872706|NCT01170533|P2|Participant Flow|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
872707|NCT01170533|P1|Participant Flow|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
872714|NCT01170533|E2|Reported Event|Pantoprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (pantoprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI (pantoprazole) therapy (CLOP regimen).
872715|NCT01170533|E1|Reported Event|Omeprazole|This was a prospective, open-label, two-sequence, three-period, randomized crossover study conducted in non-medicated healthy male subjects between the ages of 18 and 65 years. Subjects were randomized in a 1:1 fashion to take a PPI (omeprazole) concomitantly (CONC) or staggered (STAG) by 8-12 hours for one-week on a background of clopidogrel therapy. In particular, in the CONC regimen both drugs were taken in the morning, while in the STAG regimen clopidogrel was taken in the morning and the PPI (omeprazole)in the evening. After a 2-4 week washout period, subjects crossed-over treatment regimen. After completing these two treatment phases, subjects underwent another washout period of 2-4 weeks and were treated for 1 week with clopidogrel alone, without receiving PPI therapy (CLOP regimen).
872716|NCT01170390|B3|Baseline|Total|Total of all reporting groups
872717|NCT01170390|B2|Baseline|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872718|NCT01170390|B1|Baseline|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872719|NCT01170390|P3|Participant Flow|Study Arm #2 (Aviane and Portia)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872720|NCT01170390|P2|Participant Flow|Study Arm #1 (Aviane and Aviane)|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872721|NCT01170390|P1|Participant Flow|All Participants|All participants were given a low dose oral contraceptive (Aviane) cyclically for 2 months
872722|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872723|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872724|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872725|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872726|NCT01170390|O2|Outcome|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872727|NCT01170390|O1|Outcome|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872728|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872729|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872730|NCT01170390|O2|Outcome|Aviane and Portia|A low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872731|NCT01170390|O1|Outcome|Aviane & Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872732|NCT01170390|E2|Reported Event|Aviane and Portia|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A low dose oral contraceptive given cyclically (30mcg EE component, 21 days of active pills/cycle with a 7 day hormonal-free interval) for two cycles
872733|NCT01170390|E1|Reported Event|Aviane and Aviane|A very-low dose oral contraceptive given cyclically (21 days of active pills/cycle with a 7 day hormonal-free interval) for 2 cycles (56 days). A very-low dose oral contraceptive given continuously for 56 days (20mcg EE component, 28 days of active pills/cycle with no hormone free interval)
872737|NCT01170273|P2|Participant Flow|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
872738|NCT01170273|P1|Participant Flow|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
872739|NCT01170273|O2|Outcome|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
872740|NCT01170273|O1|Outcome|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
872741|NCT01170273|E2|Reported Event|Cholecalciferol 4000 IU|"cholecalciferol 4000 IU daily~vitamin D: cholecalciferol~participants received one daily tablet containing cholecalciferol 4000 IU for 9 months"
872742|NCT01170273|E1|Reported Event|Placebo Arm|"placebo capsule~placebo: placebo tablet~participants received one daily tablet containing placebo for 9 months"
872743|NCT01170221|B3|Baseline|Total|Total of all reporting groups
872744|NCT01170221|B2|Baseline|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872745|NCT01170221|B1|Baseline|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872746|NCT01170221|P2|Participant Flow|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872747|NCT01170221|P1|Participant Flow|Tedizolid Phosphate|Oral Tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872748|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872749|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872750|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872751|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872752|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872753|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872754|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872755|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872756|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872757|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872758|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872759|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872760|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872761|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872762|NCT01170221|O2|Outcome|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872763|NCT01170221|O1|Outcome|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872764|NCT01170221|E2|Reported Event|Linezolid|Oral linezolid 600 mg twice daily for 10 days
872765|NCT01170221|E1|Reported Event|Tedizolid Phosphate|Oral tedizolid phosphate 200 mg once daily for six days followed by four days of placebo
872766|NCT01170208|B4|Baseline|Total|Total of all reporting groups
872767|NCT01170208|B3|Baseline|Group III|Type 2 diabetes treated with biphasic insulin.
872768|NCT01170208|B2|Baseline|Group II|Type 2 diabetes treated with basalbolus therapy
872769|NCT01170208|B1|Baseline|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
872770|NCT01170208|P3|Participant Flow|Group III|Type 2 diabetes treated with biphasic insulin.
872771|NCT01170208|P2|Participant Flow|Group II|Type 2 diabetes treated with basalbolus therapy
872772|NCT01170208|P1|Participant Flow|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
872773|NCT01170208|O3|Outcome|Group III|Type 2 diabetes treated with biphasic insulin
872774|NCT01170208|O2|Outcome|Group II|Type 2 diabetes treated with basal bolus therapy
872775|NCT01170208|O1|Outcome|Group I|Type 1 diabetes treated with basal-bolus insulin the
872776|NCT01170208|E3|Reported Event|Group III|Type 2 diabetes treated with biphasic insulin.
872777|NCT01170208|E2|Reported Event|Group II|Type 2 diabetes treated with basalbolus therapy
872778|NCT01170208|E1|Reported Event|Group I|Type 1 diabetes treated with basal-bolus insulin therapy, incorporating carbohydrate-counting
872779|NCT01170091|B1|Baseline|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
872780|NCT01170091|P1|Participant Flow|Mirapex|Patients with RLS who had initiated with Mirapex
872781|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
872782|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
872783|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
872784|NCT01170091|O1|Outcome|Mirapex|Patients with RLS who had initiated with Mirapex
872785|NCT01170091|E1|Reported Event|Patients With Restless Legs Syndrome (RLS)|Patients with RLS who had initiated with Mirapex
872786|NCT01170039|B3|Baseline|Total|Total of all reporting groups
872787|NCT01170039|B2|Baseline|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
872788|NCT01170039|B1|Baseline|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
872789|NCT01170039|P2|Participant Flow|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
872790|NCT01170039|P1|Participant Flow|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
872791|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
872792|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
872794|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
872795|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
872796|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
872797|NCT01170039|O2|Outcome|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
872798|NCT01170039|O1|Outcome|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
872799|NCT01170039|E2|Reported Event|Placebo|Subjects with diabetes and constipation received a placebo pill twice a day for 8 weeks.
872800|NCT01170039|E1|Reported Event|Lubiprostone|Subjects with diabetes and constipation received 24 mcg of lubiprostone orally twice a day for 8 weeks.
872801|NCT01169987|B1|Baseline|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
872802|NCT01169987|P1|Participant Flow|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
872803|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872804|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872805|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872806|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872807|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872808|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872809|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872810|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872811|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872812|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872813|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872814|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872815|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872816|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872817|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872901|NCT01169701|B3|Baseline|Total|Total of all reporting groups
872956|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
892131|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
872818|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872819|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872820|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872821|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872822|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872823|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872824|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872825|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872826|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872827|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872828|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872829|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872830|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872831|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872832|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872833|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872834|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872835|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872836|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872921|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872837|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872838|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872839|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872840|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872841|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872842|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872843|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872844|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872845|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872846|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872847|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872848|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872849|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872850|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872851|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872852|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872853|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872854|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872855|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872953|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872954|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872856|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872857|NCT01169987|O6|Outcome|Participants Treated With Adalimumab: All Participants|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was one of the following: 'continuous,' early intermittent,' 'late intermittent,' 'permanently discontinued,' or 'other.'
872858|NCT01169987|O5|Outcome|Participants Treated With Adalimumab: Other|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'other' (participants not belonging to any of the previous treatment status groups).
872859|NCT01169987|O4|Outcome|Participants Treated With Adalimumab: Permanently Discontinued|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'permanently discontinued' (received ≥ 1 dose of adalimumab and stopped adalimumab treatment permanently).
872860|NCT01169987|O3|Outcome|Participants Treated With Adalimumab: Late Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'late intermittent' (initiated on adalimumab 40 mg, treated EOW for ≥ 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of at least 70 consecutive days, on treatment at study termination, and completed the study).
872861|NCT01169987|O2|Outcome|Participants Treated With Adalimumab: Early Intermittent|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'early intermittent' (initiated on adalimumab 40 mg, treated EOW for < 112 days [16 weeks] after initiation of treatment, with afterwards ≥ 1 treatment interruption period of ≥ 70 consecutive days, on treatment at study termination, and completed the study).
872862|NCT01169987|O1|Outcome|Participants Treated With Adalimumab: Continuous|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated and whose treatment status was 'continuous' (initiated on adalimumab, had no treatment interruption period, still on treatment at study termination, and completed the study).
872863|NCT01169987|O1|Outcome|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
872864|NCT01169987|E1|Reported Event|Participants Treated With Adalimumab|Participants with chronic plaque psoriasis in whom adalimumab (Humira) treatment was initiated. All medications were prescribed in the usual manner in accordance with the terms of the marketing authorization and in line with the Belgian reimbursement criteria.
872865|NCT01169779|B3|Baseline|Total|Total of all reporting groups
872866|NCT01169779|B2|Baseline|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
872867|NCT01169779|B1|Baseline|Placebo|1-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
872868|NCT01169779|P2|Participant Flow|Lixisenatide|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
872869|NCT01169779|P1|Participant Flow|Placebo|1-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 2 weeks, followed by 20 mcg QD up to Week 24.
872870|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872871|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872872|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872873|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872874|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872875|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872876|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872877|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872878|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872879|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872880|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872881|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872882|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872883|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872884|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872885|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872886|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872887|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872888|NCT01169779|O2|Outcome|Lixisenatide|1-step initiation regimen of lixisenatide.
872889|NCT01169779|O1|Outcome|Placebo|1-step initiation regimen of volume matching placebo.
872890|NCT01169779|E2|Reported Event|Lixisenatide|1-step initiation regimen of lixisenatide.
872891|NCT01169779|E1|Reported Event|Placebo|1-step initiation regimen of volume matching placebo.
872892|NCT01169753|B3|Baseline|Total|Total of all reporting groups
872893|NCT01169753|B2|Baseline|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
872894|NCT01169753|B1|Baseline|Placebo|Oral placebo every morning for 2 weeks.
872895|NCT01169753|P2|Participant Flow|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
872896|NCT01169753|P1|Participant Flow|Placebo|Oral placebo every morning for 2 weeks.
872897|NCT01169753|O2|Outcome|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
872898|NCT01169753|O1|Outcome|Placebo|Oral placebo every morning for 2 weeks.
872899|NCT01169753|E2|Reported Event|Armodafinil|Armodafinil Three 50 mg tablets orally every morning for 2 weeks.
872902|NCT01169701|B2|Baseline|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872903|NCT01169701|B1|Baseline|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872904|NCT01169701|P2|Participant Flow|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872905|NCT01169701|P1|Participant Flow|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872906|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872907|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872908|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872909|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872910|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872911|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872912|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872913|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872914|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872915|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872916|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872917|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872918|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872919|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872920|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872955|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872922|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872923|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872924|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872925|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872926|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872927|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872928|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872929|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872930|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872931|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872932|NCT01169701|O2|Outcome|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872933|NCT01169701|O1|Outcome|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872934|NCT01169701|E2|Reported Event|Everolimus|Participants received an initial dose (day 1) of Everolimus (EVL) 2mg at night and tacrolimus (if taking Prograf®, a full dose of Prograf® in the morning and a 50% dose of Prograf® at night; if taking Advagraf®, a 75% dose in the morning. On days 2 and 3, participants took EVL 2 mg twice daily (bid) without tacrolimus. On days 4 and 5, the EVL dose was adjusted and levels maintained between 5-8 ng/mL. Participants also continued with their MPA doses that were taken prior to study initiation.
872935|NCT01169701|E1|Reported Event|Tacrolimus|Participants continued with the same tacrolimus+Mycophenolic acid (MPA) (Myfortic® or Cell-Cept®) doses that were taken before study initiation (tacrolimus levels 4-7 ng/ml).
872936|NCT01169675|B6|Baseline|Total|Total of all reporting groups
872937|NCT01169675|B5|Baseline|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872938|NCT01169675|B4|Baseline|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872939|NCT01169675|B3|Baseline|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872940|NCT01169675|B2|Baseline|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872941|NCT01169675|B1|Baseline|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
872942|NCT01169675|P5|Participant Flow|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
872943|NCT01169675|P4|Participant Flow|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
872944|NCT01169675|P3|Participant Flow|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
872945|NCT01169675|P2|Participant Flow|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
872946|NCT01169675|P1|Participant Flow|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed. Afatinib is the same intervention as BIBW 2992.
872947|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872948|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872949|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872950|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872951|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
872952|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872957|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872958|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872959|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872960|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872961|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
872962|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872963|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872964|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872965|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872966|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
872967|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872968|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872969|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872970|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872971|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
872972|NCT01169675|O5|Outcome|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872973|NCT01169675|O4|Outcome|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872974|NCT01169675|O3|Outcome|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872975|NCT01169675|O2|Outcome|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872976|NCT01169675|O1|Outcome|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
872977|NCT01169675|E5|Reported Event|Pulsed Afatinib 70 mg|Pulsed Afatinib 70 mg plus Pemetrexed
872978|NCT01169675|E4|Reported Event|Pulsed Afatinib 60 mg|Pulsed Afatinib 60 mg plus Pemetrexed
872979|NCT01169675|E3|Reported Event|Pulsed Afatinib 50 mg|Pulsed Afatinib 50 mg plus Pemetrexed
872980|NCT01169675|E2|Reported Event|Continuous Afatinib 40 mg|Continuous Afatinib 40 mg plus Pemetrexed
872981|NCT01169675|E1|Reported Event|Continuous Afatinib 30 mg|Continuous Afatinib 30 mg plus Pemetrexed
872982|NCT01169649|B1|Baseline|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
872983|NCT01169649|P1|Participant Flow|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
872984|NCT01169649|O1|Outcome|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
872985|NCT01169649|E1|Reported Event|MK-2206 in Patients With Metastatic Neuroendocrine Tumors|This is an open label phase II study of MK-2206 administered to patients with metastatic neuroendocrine tumors.
872986|NCT01169610|B1|Baseline|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872987|NCT01169610|P1|Participant Flow|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872988|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872989|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872990|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872991|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872992|NCT01169610|O1|Outcome|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872993|NCT01169610|E1|Reported Event|Open Label|Varenicline : Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
872994|NCT01169558|B1|Baseline|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
872995|NCT01169558|P1|Participant Flow|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
873055|NCT01169467|B1|Baseline|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
872996|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
872997|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
872998|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
872999|NCT01169558|O1|Outcome|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
873000|NCT01169558|E1|Reported Event|Bevacizumab|Bevacizumab (5 mg/kg intravenously every 2 weeks or 7.5 mg/kg intravenously every 3 weeks) was administered in combination with fluoropyrimidine-based chemotherapy as first line treatment in participants with metastatic cancer of the colon or rectum until disease progression or study completion.
873001|NCT01169519|B1|Baseline|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
873002|NCT01169519|P1|Participant Flow|Baseline/Sildenafil|Assessment of baseline hemodynamics followed by sildenafil infusion with repeat assessment of hemodynamics
873003|NCT01169519|O2|Outcome|Sildenafil|"Pharmacokinetic and hemodynamic evaluation following sildenafil administration~Sildenafil by injection : Sildenafil 0.45mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.25mg/kg injection over 20min~Sildenafil by injection : Sildenafil 0.35mg/kg by injection over 20min~Sildenafil by injection : Sildenafil 0.125mg/kg injection over 20min"
873004|NCT01169519|O1|Outcome|Baseline|Assessment of baseline hemodynamics
873005|NCT01169519|O4|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.25mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusionplasma concentration
873006|NCT01169519|O3|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.45mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
873007|NCT01169519|O2|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.35mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
873008|NCT01169519|O1|Outcome|Peak Sildenafil Level (ng/mL) for Dose = 0.125mg/kg|Maximum sildenafil plasma concentration measured 5 minutes after completion of sildenafil infusion
873009|NCT01169519|E4|Reported Event|Dose = 0.45mg/kg|Subjects receiving a sildenafil dose of 0.45mg/kg IV over 20 min
873010|NCT01169519|E3|Reported Event|Dose = 0.35mg/kg|Subjects receiving a sildenafil dose of 0.35mg/kg IV over 20 min
873011|NCT01169519|E2|Reported Event|Dose = 0.25mg/kg|Subjects receiving a sildenafil dose of 0.25mg/kg IV over 20 min
873012|NCT01169519|E1|Reported Event|Dose = 0.125mg/kg|Subjects receiving a sildenafil dose of 0.125mg/kg IV over 20 min
873013|NCT01169493|B7|Baseline|Total|Total of all reporting groups
873014|NCT01169493|B6|Baseline|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873015|NCT01169493|B5|Baseline|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873016|NCT01169493|B4|Baseline|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873017|NCT01169493|B3|Baseline|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873018|NCT01169493|B2|Baseline|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873019|NCT01169493|B1|Baseline|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873056|NCT01169467|P2|Participant Flow|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
873672|NCT01167023|B1|Baseline|Placebo|Participants received placebo orally, once daily for 30 days.
873020|NCT01169493|P6|Participant Flow|RV DDD-40 to Bi-V DDD-40 to VVI-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873021|NCT01169493|P5|Participant Flow|RV DDD-40 to VVI-40 to Bi-V DDD-40|"Period 1: Participants assigned to RV DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873022|NCT01169493|P4|Participant Flow|Bi-V DDD-40 to RV DDD-40 to VVI-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2. Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3. Period 3: Participants assigned to VVI-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873023|NCT01169493|P3|Participant Flow|Bi-V DDD-40 to VVI-40 to RV DDD-40|"Period 1: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to VVI-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873024|NCT01169493|P2|Participant Flow|VVI-40 to Bi-V DDD-40 to RV DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to Bi-V DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to RV DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873025|NCT01169493|P1|Participant Flow|VVI-40 to RV DDD-40 to Bi-V DDD-40|"Period 1: Participants assigned to VVI-40 Participants will then Crossover to Period 2.~Period 2: Participants assigned to RV DDD-40 Participants will then Crossover to Period 3.~Period 3: Participants assigned to Bi-V DDD-40~VVI-40: Pacing mode set to VVI-40, RV only pacing~RV DDD-40: ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.~BiV DDD-40: ICD programmed to BiV pacing at a lower rate of 40"
873026|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873027|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873028|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873029|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873030|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873031|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873032|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873033|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873034|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873035|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873036|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873037|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873038|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873039|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873040|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873041|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873042|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873043|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873044|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873045|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873046|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873047|NCT01169493|O3|Outcome|Bi-V DDD-40|Permits direct comparison of RV univentricular pacing and current standard of care (BiV) pacing.
873048|NCT01169493|O2|Outcome|RV DDD-40|RV DDD-40 will have an AV interval set to produce QRS fusion with the native conduction down the native left bundle
873049|NCT01169493|O1|Outcome|VVI-40|The VVI-40 arm will be programmed to VVI (inhibited) mode at a lower rate of 40.
873050|NCT01169493|E3|Reported Event|Bi-V DDD-40|Bi-V DDD-40: ICD programmed to Bi-V pacing at a lower rate of 40
873051|NCT01169493|E2|Reported Event|RV DDD-40|RV DDD-40: ICD programmed to DDD-40, RV only pacing with an AV interval producing QRS fusion on surface EKG.
873052|NCT01169493|E1|Reported Event|VVI-40|VVI-40: Pacing mode set to VVI-40, RV only pacing
873053|NCT01169467|B3|Baseline|Total|Total of all reporting groups
873054|NCT01169467|B2|Baseline|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
875474|NCT01161329|E2|Reported Event|Intervention Group|High Intensity Functional Exercise Program
873057|NCT01169467|P1|Participant Flow|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
873058|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
873059|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
873060|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
873061|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
873062|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
873063|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
873064|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
873065|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
873066|NCT01169467|O2|Outcome|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
873067|NCT01169467|O1|Outcome|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
873068|NCT01169467|E2|Reported Event|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
873069|NCT01169467|E1|Reported Event|Standard-of-Care Plus Precedex|Standard-of-Care plus Dexmedetomidine: Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
873070|NCT01169311|B1|Baseline|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
873071|NCT01169311|P1|Participant Flow|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
873072|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873073|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873074|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873075|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects meeting inclusion/exclusion criteria will undergo hemorrhoidopexy with the Covidien EEA hemorrhoid and prolapse stapler set.
873076|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873077|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873078|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873079|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873080|NCT01169311|O1|Outcome|Covidien EEA Hemorrhoid and Prolapse Stapler|subjects will have have hemorrhoidopexy using the EEA stapler
873081|NCT01169311|E1|Reported Event|Covidien EEA Hemorrhoid and Prolapse Stapler|Subjects undergoing hemorrhoidopexy with HEEA stapler
873082|NCT01169103|B3|Baseline|Total|Total of all reporting groups
873083|NCT01169103|B2|Baseline|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873084|NCT01169103|B1|Baseline|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873085|NCT01169103|P2|Participant Flow|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873086|NCT01169103|P1|Participant Flow|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873087|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873088|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873089|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873090|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873091|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873092|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873093|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873094|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873095|NCT01169103|O2|Outcome|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873096|NCT01169103|O1|Outcome|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873097|NCT01169103|E2|Reported Event|Placebo/no Treatment|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo.~Placebo : Placebo will be administered by daily subcutaneous injections. Sham increases will be used. Due to expiration of placebo medication, placebo subjects who enrolled after 6/2012 were randomized to no treatment."
873098|NCT01169103|E1|Reported Event|Recombinant Human Growth Hormone|"Forty subjects will be randomized to receive either recombinant human growth hormone or placebo/no treatment.~recombinant human growth hormone (rhGH) : Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks."
873099|NCT01169064|B3|Baseline|Total|Total of all reporting groups
873100|NCT01169064|B2|Baseline|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
873101|NCT01169064|B1|Baseline|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
873102|NCT01169064|P2|Participant Flow|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
873103|NCT01169064|P1|Participant Flow|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
873104|NCT01169064|O2|Outcome|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
873105|NCT01169064|O1|Outcome|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
873106|NCT01169064|O2|Outcome|Cloth Dressing|
873107|NCT01169064|O1|Outcome|Silver Dressing|
873108|NCT01169064|O2|Outcome|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days"
873109|NCT01169064|O1|Outcome|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days"
873110|NCT01169064|E2|Reported Event|Cloth Adhesive Dressing|"Soft cloth adhesive wound dressing~Cloth adhesive dressing: Cloth adhesive dressing placed over surgical incision and remains for 3-5 days~No adverse events"
873111|NCT01169064|E1|Reported Event|Silver-containing Surgical Dressing|"Self adhesive 4 x 10 dressing impregnated with nanocrystalline silver~Silver-containing surgical dressing: Dressing placed over surgical incision and remain for 3-5 days~No adverse events"
873112|NCT01169038|B1|Baseline|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
873113|NCT01169038|P1|Participant Flow|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
873114|NCT01169038|O1|Outcome|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
873115|NCT01169038|E1|Reported Event|Antibiotics|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
873116|NCT01168999|B5|Baseline|Total|Total of all reporting groups
873117|NCT01168999|B4|Baseline|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873118|NCT01168999|B3|Baseline|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873119|NCT01168999|B2|Baseline|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873120|NCT01168999|B1|Baseline|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873121|NCT01168999|P4|Participant Flow|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873122|NCT01168999|P3|Participant Flow|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873123|NCT01168999|P2|Participant Flow|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873124|NCT01168999|P1|Participant Flow|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873125|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873126|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873127|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873128|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873129|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873130|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873131|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873132|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873133|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873134|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873135|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873136|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873137|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873138|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873139|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873140|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873141|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873142|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873143|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873144|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873145|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873146|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873147|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873148|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873149|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873150|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873151|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873152|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873153|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873238|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873154|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873155|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873156|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873157|NCT01168999|O4|Outcome|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873158|NCT01168999|O3|Outcome|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873159|NCT01168999|O2|Outcome|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873160|NCT01168999|O1|Outcome|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873161|NCT01168999|E4|Reported Event|Natural History|These participants sat quietly for 5 minutes during the initial and final testing sessions.
873162|NCT01168999|E3|Reported Event|Enhanced Sham Spinal Manipulative Therapy|Received the sham spinal manipulative therapy with the instructional set The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people for 6 sessions over 2 weeks.
873163|NCT01168999|E2|Reported Event|Sham Spinal Manipulative Therapy|Received a sham spinal manipulative therapy for 6 sessions over 2 weeks.
873164|NCT01168999|E1|Reported Event|Spinal Manipulative Therapy|Received a spinal manipulative therapy commonly provided to individuals with low back pain for 6 sessions over 2 weeks
873165|NCT01168986|B4|Baseline|Total|Total of all reporting groups
873166|NCT01168986|B3|Baseline|No Intervention|Participants receive/perform no intervention
873167|NCT01168986|B2|Baseline|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
873168|NCT01168986|B1|Baseline|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
873169|NCT01168986|P3|Participant Flow|No Intervention|Participants receive/perform no intervention
873170|NCT01168986|P2|Participant Flow|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
873171|NCT01168986|P1|Participant Flow|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
873172|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
873173|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
873174|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
873175|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
873176|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
873177|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
873178|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
873179|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
873180|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
873181|NCT01168986|O3|Outcome|No Intervention|Participants receive/perform no intervention
873182|NCT01168986|O2|Outcome|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
873183|NCT01168986|O1|Outcome|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
873184|NCT01168986|E3|Reported Event|No Intervention|Participants receive/perform no intervention
873185|NCT01168986|E2|Reported Event|Exercise|"Participants perform an exercise to strengthen the deep neck flexors~Exercise: Participants perform an exercise to strengthen the deep neck flexors"
873186|NCT01168986|E1|Reported Event|Pulstar Multiple Impulse Therapy|"Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.~Pulstar Multiple Impulse Therapy: Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device."
873187|NCT01168973|B3|Baseline|Total|Total of all reporting groups
873188|NCT01168973|B2|Baseline|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873239|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
875475|NCT01161329|E1|Reported Event|Controlgroup|Ordinary life.
873189|NCT01168973|B1|Baseline|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873190|NCT01168973|P2|Participant Flow|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873191|NCT01168973|P1|Participant Flow|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab drug product (DP) followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 milligrams per kilogram (mg/kg) administered intravenously.~Docetaxel: 75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873192|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873193|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873194|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873195|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873196|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873197|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873198|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873199|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873200|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873201|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873202|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873203|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873204|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
875476|NCT01161225|B4|Baseline|Total|Total of all reporting groups
873205|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873206|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873207|NCT01168973|O2|Outcome|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873208|NCT01168973|O1|Outcome|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873209|NCT01168973|E2|Reported Event|Placebo and Docetaxel|"On Day 1 of each 21-day cycle, participants received placebo followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Placebo (matching Ramucirumab DP): 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873210|NCT01168973|E1|Reported Event|Ramucirumab and Docetaxel|"On Day 1 of each 21-day cycle, participants received ramucirumab DP followed by docetaxel. Treatment continued until disease progression, unacceptable toxicity, or other withdrawal criteria were met.~Ramucirumab DP: 10 mg/kg administered intravenously.~Docetaxel: 75 mg/m^2 (60 mg/m^2 for the countries of Korea and Taiwan only, with protocol amendment dated 22 May 2012) administered intravenously."
873211|NCT01168934|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 50 mg IV first and crizotinib 250 mg oral first.
873212|NCT01168934|P2|Participant Flow|Crizotinib 250 mg Oral First, Then Crizotinib 50 mg IV|Single oral dose of crizotinib 250 mg IRT in first intervention period; and single IV dose of crizotinib 50 mg in second intervention period. A washout period of at least 14 days was maintained between each period.
873213|NCT01168934|P1|Participant Flow|Crizotinib 50 mg IV First, Then Crizotinib 250 mg Oral|Single intravenous (IV) dose of crizotinib 50 milligram (mg) in first intervention period; and single oral dose of crizotinib 250 mg immediate release tablet (IRT) in second intervention period. A washout period of at least 14 days was maintained between each period.
873214|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873215|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873216|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873217|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873218|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873219|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873220|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873221|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873222|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873223|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873224|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873225|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873226|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873227|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873228|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873229|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873230|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873231|NCT01168934|O1|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873232|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873233|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873234|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873235|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873236|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873237|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
875541|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
873240|NCT01168934|O2|Outcome|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873241|NCT01168934|O1|Outcome|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873242|NCT01168934|E2|Reported Event|Crizotinib 250 mg Oral|Single oral dose of crizotinib 250 mg (Treatment B [Test]) in either intervention period.
873243|NCT01168934|E1|Reported Event|Crizotinib 50 mg IV|Single IV dose of crizotinib 50 mg (Treatment A [Reference]) in either intervention period.
873244|NCT01168856|B3|Baseline|Total|Total of all reporting groups
873245|NCT01168856|B2|Baseline|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873246|NCT01168856|B1|Baseline|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873247|NCT01168856|P2|Participant Flow|Sustained Virological Response (SVR) Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873248|NCT01168856|P1|Participant Flow|Resistance Monitoring Arm|Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873249|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV20536 [NCT00869661], WV21913 [NCT01331850], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], NP28266 [NCT01628094]. None of the enrolled patients had developed MCB-associated resistant mutation(s) in donor protocol. Participants were monitored up to 18 months.
873250|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
873251|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in the following donor protocol: NP28266 [NCT01628094]. Patients had developed STV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
873252|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV27779 [NCT01482390], NV27780 [NCT01482403]. Patients had developed BOC- or TVR-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
873253|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
873254|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
873255|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following donor protocols: NV21075 [NCT00963885], WV21913 [NCT01331850], NP22660 [NCT01185860], NV22776 [NCT01220947], PP25213 [NCT01278134], NP27946 [NCT01483742], NP28266 [NCT01628094]. Patients had developed DNV-associated resistant mutation(s), which persisted or not through to the last evaluation of drug resistance in the donor protocol(s). Participants were monitored up to 18 months.
873310|NCT01168726|P1|Participant Flow|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
875542|NCT01160848|E2|Reported Event|3 Areas Per Patient, 24 Hours|
873256|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873257|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873258|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873259|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873260|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873261|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873262|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873263|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873264|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873265|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873266|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873311|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
873312|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
873267|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873268|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873269|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873270|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873271|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873272|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873273|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873274|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873275|NCT01168856|O1|Outcome|SVR Durability Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
873276|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873277|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873278|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873279|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873280|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873281|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873282|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873283|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873284|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873285|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873286|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873342|NCT01168674|E1|Reported Event|Placebo|Placebo administered double-blind.
873343|NCT01168596|B3|Baseline|Total|Total of all reporting groups
873287|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873288|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873289|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873290|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873291|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873292|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873293|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873294|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873295|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873476|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873296|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873297|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873298|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873299|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873300|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873301|NCT01168856|O1|Outcome|Resistance Monitoring Arm|Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
873302|NCT01168856|E2|Reported Event|SVR Durability Monitoring Arm|Participants enrolled into this study were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had Achieved Sustained Virological Response (SVR-24), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test more than or equal to (≥) 20 weeks after the last dose of study medication.
873303|NCT01168856|E1|Reported Event|Resistance Monitoring Arm|Participants enrolled into this study were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations.
873304|NCT01168726|B4|Baseline|Total|Total of all reporting groups
873305|NCT01168726|B3|Baseline|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
873306|NCT01168726|B2|Baseline|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
873307|NCT01168726|B1|Baseline|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
873308|NCT01168726|P3|Participant Flow|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
873309|NCT01168726|P2|Participant Flow|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
873477|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873313|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
873314|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
873315|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
873316|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
873317|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
873318|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
873319|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
873320|NCT01168726|O3|Outcome|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
873321|NCT01168726|O2|Outcome|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
873322|NCT01168726|O1|Outcome|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
873323|NCT01168726|E3|Reported Event|Alcohol Education|Alcohol Education: Educational information about harms associated with heavy drinking.
873324|NCT01168726|E2|Reported Event|Personalized Normative Feedback|Personalized Normative Feedback: Personalized feedback on how one's own drinking compares to relevant norms.
873325|NCT01168726|E1|Reported Event|Protective Behavioral Strategies|Protective Behavioral Strategies Feedback: Personalized feedback on use of protective behavioral strategies.
873326|NCT01168687|B3|Baseline|Total|Total of all reporting groups
873327|NCT01168687|B2|Baseline|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.~Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
873328|NCT01168687|B1|Baseline|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
873329|NCT01168687|P2|Participant Flow|Group B: Crossover Between High Dose Keppra and Placebo|"Group B: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days.~Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period."
873330|NCT01168687|P1|Participant Flow|Group A: Crossover Between Low Dose Keppra and Placebo|Group A: Twenty moderate to heavy social alcohol users (women 7-20 drinks/week --moderate 7-14 and heavy 15-20 and men 15-25 drinks/week --moderate 7-14 and heavy 15-25 drinks/week) will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) or will receive a double dose of placebo x 7 days. Participants on active drug for the first 14 days then crossed over to placebo after a 10-14 day washout period. Similarly, participants on placebo for the first 14 days then crossed over to active drug after a 10-14 day washout period.
873331|NCT01168687|O2|Outcome|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
873332|NCT01168687|O1|Outcome|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
873333|NCT01168687|E2|Reported Event|All Subjects (n = 46) Levetiracetam|23 moderate social drinkers. 23 heavy social drinkers.
873334|NCT01168687|E1|Reported Event|All Subjects (n = 46) Placebo|23 moderate social drinkers. 23 heavy social drinkers.
873335|NCT01168674|B1|Baseline|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
873336|NCT01168674|P2|Participant Flow|Ziprasidone-washout-placebo|ziprasidone : Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Placebo, for another 6 weeks, using same dosing techniques.
873337|NCT01168674|P1|Participant Flow|Placebo-washout-ziprasidone|Placebo : The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly. This will be 6 weeks and then followed by a one week washout and then cross over to the other arm, Ziprazidone, for another 6 weeks, using same dosing techniques.
873338|NCT01168674|O1|Outcome|All Study Participants|All participants were randomized to either placebo followed by ziprasidone crossover, or ziprsidone followed by placebo crossover.
873339|NCT01168674|O2|Outcome|Ziprasidone|Subjects randomized to ziprasidone in either the initial or crossover phase.
873340|NCT01168674|O1|Outcome|Placebo|Subjects randomized to placebo in either the initial or crossover phase
873341|NCT01168674|E2|Reported Event|Ziprasidone|Active ziprasidone administered double-blind.
873344|NCT01168596|B2|Baseline|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873345|NCT01168596|B1|Baseline|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873346|NCT01168596|P2|Participant Flow|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873347|NCT01168596|P1|Participant Flow|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873348|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873349|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873350|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873351|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873352|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873353|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873354|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873355|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873356|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873357|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873358|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873359|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873360|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873361|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873362|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873363|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873364|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873365|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873366|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873367|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873368|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873369|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873370|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873371|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873372|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873373|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873612|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
873374|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873375|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873376|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873377|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873378|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873379|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873380|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873381|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873382|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873383|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873384|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873385|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873386|NCT01168596|O2|Outcome|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873387|NCT01168596|O1|Outcome|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873388|NCT01168596|E2|Reported Event|Sugar Pill|"Placebo tablet, 1 per day, duration is approximately 12 weeks.~Placebo : Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks."
873389|NCT01168596|E1|Reported Event|Rasagiline|"Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks.~Rasagiline : Comparison of Rasagiline versus placebo.~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
873390|NCT01168427|B1|Baseline|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
873391|NCT01168427|P1|Participant Flow|Enrollment Cohort|Enrollment cohort includes any patients who meet the inclusion and exclusion criteria and have a signed inform consent.
873392|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
873393|NCT01168427|O1|Outcome|Implant Cohort|Patient with Reveal device implanted
873394|NCT01168427|E1|Reported Event|Implant Cohort|Patient with Reveal device implanted
873395|NCT01168349|B1|Baseline|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873396|NCT01168349|P1|Participant Flow|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873397|NCT01168349|O9|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873398|NCT01168349|O8|Outcome|Chronic Lymphocytic Leukemia Participants|Chronic lymphocytic leukemia participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873399|NCT01168349|O7|Outcome|Hodgkin's Lymphoma Participants|Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873400|NCT01168349|O6|Outcome|Non-Hodgkin's Lymphoma Participants|Non-Hodgkin’s lymphoma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873401|NCT01168349|O5|Outcome|Multiple Myeloma Participants|Multiple myeloma participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873402|NCT01168349|O4|Outcome|Ovary Cancer Participants|Ovary cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873403|NCT01168349|O3|Outcome|Colon/Rectum Cancer Participants|Colon/rectum cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873404|NCT01168349|O2|Outcome|Breast Cancer Participants|Breast cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873405|NCT01168349|O1|Outcome|Lung Cancer Participants|Lung cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873406|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873407|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873408|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873409|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873410|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873411|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873412|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873413|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873414|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873415|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873416|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873417|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873418|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873419|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873420|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873421|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873422|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873423|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873424|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873425|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873426|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873427|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873428|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873429|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873430|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873431|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873432|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873433|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873434|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873435|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873436|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873437|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873438|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873439|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873440|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873441|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873442|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873443|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873444|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873445|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873446|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873447|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873448|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873449|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873450|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873451|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873452|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873453|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873454|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873455|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873456|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873457|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873458|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873459|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873460|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873461|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873462|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873463|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873464|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873465|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873466|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873467|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873468|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873469|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873470|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873471|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873472|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873473|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873474|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873475|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873478|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873479|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873480|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873481|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873482|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873483|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873484|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873485|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873486|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873487|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873488|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873489|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873490|NCT01168349|O2|Outcome|Non-responders|Participants who did not have an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873491|NCT01168349|O1|Outcome|Responders|Participants who had an increase of Hb concentration of at least 1 g/dL, 3 to 6 weeks after treatment initiation.
873492|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873493|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873494|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873495|NCT01168349|O3|Outcome|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873496|NCT01168349|O2|Outcome|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, Chronic Lymphocytic Leukemia [CLL], and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873497|NCT01168349|O1|Outcome|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873498|NCT01168349|E3|Reported Event|Anemic Cancer Participants (Total Participants)|Anemic cancer participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873499|NCT01168349|E2|Reported Event|Hematological Malignancy Participants|Hematological malignancy (multiple myeloma, CLL, and lymphoma) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873500|NCT01168349|E1|Reported Event|Solid Tumor Participants|Solid tumor (breast, colorectal, lung, and ovary) participants on NeoRecormon® injection were observed until Week 24 to 28 or early withdrawal due to death, participants’ will to end the study, lost to follow-up or other reasons. The dose and frequency of NeoRecormon® were at the discretion of treating physician.
873501|NCT01168232|B1|Baseline|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
873502|NCT01168232|P1|Participant Flow|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
873503|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
873665|NCT01167140|P1|Participant Flow|Treatment Group|
873666|NCT01167140|O1|Outcome|Treatment Group|
873504|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
873505|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
873506|NCT01168232|O1|Outcome|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
873507|NCT01168232|E1|Reported Event|Ixabepilone|Ixabepilone administered at 40 mg/m2 IV infusion over 3 hours on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
873508|NCT01168024|B3|Baseline|Total|Total of all reporting groups
873509|NCT01168024|B2|Baseline|Standard of Care|"Peri-procedural hydration with isotonic saline or sodium bicarbonate for at least 2 hours prior to the procedure and 6-12 hours post-procedure.~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
873510|NCT01168024|B1|Baseline|CINCOR™ System Treatment|"Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.~CINCOR™ System and CCS-1: Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media~Peri-procedural hydration: The control group will receive a peri and post-procedural hydration rate."
873511|NCT01168024|P2|Participant Flow|Standard of Care Plus Peri-procedural Hydration|Peri-procedural hydration utilized prior to standard of care PCI.
873512|NCT01168024|P1|Participant Flow|CINCOR™ System and CCS-1|Use of the CINCOR™ System and CCS-1 device during the PCI procedure plus Standard of Care peri-procedural hydration for the prevention of CIN.
873513|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
873514|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
873515|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
873516|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
873517|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
873518|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
873519|NCT01168024|O2|Outcome|Control|Peri-procedure hydration
873520|NCT01168024|O1|Outcome|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
873521|NCT01168024|E2|Reported Event|Control|Peri-procedure hydration
873522|NCT01168024|E1|Reported Event|Treatment (Roll In and Randomized)|CINCOR, CCS-1 and Peri-procedure hydration
873523|NCT01167881|B3|Baseline|Total|Total of all reporting groups
873524|NCT01167881|B2|Baseline|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873525|NCT01167881|B1|Baseline|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873526|NCT01167881|P2|Participant Flow|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873527|NCT01167881|P1|Participant Flow|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873528|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873529|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873530|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873531|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873532|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873533|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873534|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873535|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873536|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873537|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873538|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873539|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873540|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873541|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873542|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873543|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873544|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873545|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873546|NCT01167881|O2|Outcome|Glimepiride|"Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily.~Glimepiride: 1-4 mg once daily~Placebo: Placebo matching Empagliflozin"
873547|NCT01167881|O1|Outcome|Empaglifozin 25 mg|"Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily.~Empagliflozin: 25 mg once daily~Placebo: Placebo matching Glimepiride"
873548|NCT01167881|E2|Reported Event|Glimepiride|Patients received one Glimepiride capsule and one placebo Empagliflozin tablet orally once daily. Glimepiride: 1-4 mg once daily Placebo: Placebo matching Empagliflozin
873549|NCT01167881|E1|Reported Event|Empa 25mg|Patients received one Empagliflozin 25 mg tablet and one placebo Glimepiride capsule orally once daily. Empagliflozin: 25 mg once daily Placebo: Placebo matching Glimepiride
873550|NCT01167829|B1|Baseline|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
873551|NCT01167829|P1|Participant Flow|Acyline and 0ral Testosterone|Acyline 300 mcg/kg subcutaneous + 300mg modified slow-release oral testosterone tid
873552|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
873553|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
873554|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
873555|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
873556|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
873557|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
873558|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
873559|NCT01167829|O1|Outcome|300 mg Oral Testosterone|300 mg oral testosterone three times daily
873560|NCT01167829|O1|Outcome|Acyine and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
873561|NCT01167829|O1|Outcome|Acyline and 300 mg Oral Testosterone|300 mg oral testosterone three times daily
873562|NCT01167829|E1|Reported Event|Acyline and Oral Testosterone|300 mcg/kg acyline, and modified slow-release oral testosterone 300 mg
873563|NCT01167608|B1|Baseline|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
873564|NCT01167608|P1|Participant Flow|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
873565|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
873566|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
873567|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
873568|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
873569|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study.: No intervention.
873570|NCT01167608|O1|Outcome|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
873571|NCT01167608|E1|Reported Event|People With Parkinson's Disease|No Intervention. This is a cross-sectional survey study. : No intervention.
873572|NCT01167582|B3|Baseline|Total|Total of all reporting groups
873573|NCT01167582|B2|Baseline|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
873574|NCT01167582|B1|Baseline|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
873575|NCT01167582|P2|Participant Flow|Restrictive Transfusion Strategy|"Receive a transfusion if they develop symptoms related to anemia. Transfusion is also permitted, but not required, in the absence of symptoms only if the hemoglobin concentration falls below 8 g/dL. Blood is administered one unit at a time and the presence of symptoms is reassessed. Only enough blood is given to relieve symptoms. If the transfusion is given because the hemoglobin concentration falls below 8 g/dL, then only enough blood is given to increase the hemoglobin concentration above 8 g/dL.~Symptoms of anemia that will be indications for transfusion are: 1) Definite angina requiring treatment with sublingual nitroglycerin or equivalent therapy. 2) Unexplained tachycardia or hypotension."
873576|NCT01167582|P1|Participant Flow|Liberal Transfusion Strategy|Patients randomly allocated to the liberal transfusion strategy receive one unit of packed red cells following randomization and receive enough blood to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days. Any transfusion following the initial unit of packed red cells must be preceded by blood test documenting a hemoglobin concentration below 10 g/dL.
873577|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
873578|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
873579|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL
873580|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
873581|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
873582|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
873583|NCT01167582|O2|Outcome|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
873584|NCT01167582|O1|Outcome|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
873585|NCT01167582|E2|Reported Event|Restrictive Transfusion Strategy|Patients transfused if they develop symptoms related to anemia or at physician discretion if the hemoglobin concentration falls below 8 g/dL.
873586|NCT01167582|E1|Reported Event|Liberal Transfusion Strategy|Patients receive red blood cell transfusion to raise the hemoglobin concentration above 10 g/dL any time the hemoglobin concentration is detected to be below 10g/dL during the hospitalization for up to 30 days
873587|NCT01167504|B1|Baseline|Saliva Sample Collection|Collection of whole mouth and parotid saliva
873588|NCT01167504|P1|Participant Flow|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
873589|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
873590|NCT01167504|O1|Outcome|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
873591|NCT01167504|E1|Reported Event|Saliva Sample Collection|Collection of whole mouth and parotid saliva samples
873592|NCT01167452|B1|Baseline|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose oral dose of TMP/SMX (1600 mg/320 mg).
873593|NCT01167452|P1|Participant Flow|Sulfamethoxazole/Trimethoprim|"2 DS tablets of sulfamehtoxazole/trimethoprim (1600 mg/320 mg)~Sulfamethoxazole/trimethoprim: 2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose"
873594|NCT01167452|O2|Outcome|Trimethoprim|Results from trimethoprim analysis
873595|NCT01167452|O1|Outcome|Sulfamethoxazole|Results from sulfamethoxazole analysis
873596|NCT01167452|E1|Reported Event|Sulfamethoxazole/Trimethoprim|All volunteers received a single dose of TMP/SMX (1600 mg/320 mg).
873597|NCT01167426|B1|Baseline|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
873598|NCT01167426|P1|Participant Flow|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
873599|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
873600|NCT01167426|O1|Outcome|Glatiramer Acetate|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
873601|NCT01167426|E2|Reported Event|Period 2: Glatirimer Actetate|Participants received once daily subcutaneous administration of glatiramer acetate 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
873602|NCT01167426|E1|Reported Event|Period 1: Glatiramer Acetate 20 mg/1.0 mL|Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1).
873603|NCT01167257|B3|Baseline|Total|Total of all reporting groups
873604|NCT01167257|B2|Baseline|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
873605|NCT01167257|B1|Baseline|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80mg/40ml) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873606|NCT01167257|P2|Participant Flow|Control Arm|"Normal saline 50ml in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
873607|NCT01167257|P1|Participant Flow|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873608|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
873609|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873610|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
873611|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873667|NCT01167140|O1|Outcome|Treatment Group|
873668|NCT01167140|O1|Outcome|Treatment Group|
873613|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873614|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
873615|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 Ll water) in single intravesical instillation, one time treatment at the treatment day"
873616|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
873617|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873618|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
873619|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10ml in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873620|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
873621|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873622|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50ml in single intravesical instillation"
873623|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873624|NCT01167257|O2|Outcome|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
873625|NCT01167257|O1|Outcome|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873626|NCT01167257|E2|Reported Event|Control Arm|"Normal saline 50 mL in single intravesical instillation~Normal saline instillation'~Normal saline instillation: Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation"
873627|NCT01167257|E1|Reported Event|Experimental Arm|"Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL in Liposome 80 mg/40 mL) in single intravesical instillation~Liposome encapsulated botulinum toxin A'~Liposome encapsulated botulinum toxin A: Liposome encapsulated BoNT-A (mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day"
873628|NCT01167192|B1|Baseline|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873629|NCT01167192|P1|Participant Flow|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873630|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873631|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873632|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873633|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873669|NCT01167140|E1|Reported Event|Treatment Group|
873670|NCT01167023|B3|Baseline|Total|Total of all reporting groups
873671|NCT01167023|B2|Baseline|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873634|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873635|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873636|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873637|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873638|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873639|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873640|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873641|NCT01167192|O1|Outcome|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873642|NCT01167192|E1|Reported Event|Neoadjuvant Cisplatin or Carboplatin AUC 6 & Radiation|"Cisplatin 75 mg/m^2 IV every 21 days for 4 cycles or Carboplatin AUC 6 IV every 21 days for 4 cycles.~Radiation beginning cycle 2 day 1 daily for 5-6 weeks 45-50 Gy.~Recommended mastectomy~Recommended adjuvant chemotherapy~-Doxorubicin 60 mg/m^2 and cyclophosphamide 600 mg/m^2 for 14 days for 4 cycles followed by paclitaxel 175 mg/m^2 for 14 days for 4 cycles)"
873643|NCT01167153|B3|Baseline|Total|Total of all reporting groups
873644|NCT01167153|B2|Baseline|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873645|NCT01167153|B1|Baseline|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873646|NCT01167153|P2|Participant Flow|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873647|NCT01167153|P1|Participant Flow|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873648|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873649|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873650|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873651|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873652|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873653|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873654|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873655|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873656|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873657|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873658|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873659|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873660|NCT01167153|O2|Outcome|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873661|NCT01167153|O1|Outcome|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873662|NCT01167153|E2|Reported Event|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873663|NCT01167153|E1|Reported Event|Valsartan/Amlodipine|Valsartan/amlodipine 80/5 mg, one tablet once daily at 8:00 a.m. everyday for 12 weeks.
873664|NCT01167140|B1|Baseline|Group 1|
873673|NCT01167023|P3|Participant Flow|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873674|NCT01167023|P2|Participant Flow|Placebo|Participants received placebo orally, once daily for 30 days.
873675|NCT01167023|P1|Participant Flow|7.5 mg Prasugrel|Participants were to receive 7.5 milligrams (mg) of prasugrel orally, once daily if they weighed ≥60 kilograms (kg) and if pharmacodynamic (PD) measures indicated that the 5-mg prasugrel dose did not produce a steady-state PD response equivalent to inhibition of platelet activation (IPA) ≥25%. Because these criteria were not met, no participants received 7.5 mg of prasugrel.
873676|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873677|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
873678|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873679|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
873680|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873681|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
873682|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873683|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
873684|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873685|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
873686|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873687|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
873688|NCT01167023|O2|Outcome|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873689|NCT01167023|O1|Outcome|Placebo|Participants received placebo orally, once daily for 30 days.
873690|NCT01167023|E2|Reported Event|5 mg Prasugrel|Participants received 5 mg of prasugrel orally, once daily for 30 days.
873691|NCT01167023|E1|Reported Event|Placebo|Participants received placebo orally, once daily for 30 days.
873692|NCT01166997|B3|Baseline|Total|Total of all reporting groups
873693|NCT01166997|B2|Baseline|UFH + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
873694|NCT01166997|B1|Baseline|UFH (Alone)|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
873695|NCT01166997|P2|Participant Flow|Unfractionated Heparin (UFH) + EkoSonic Procedure|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
873696|NCT01166997|P1|Participant Flow|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
873697|NCT01166997|O2|Outcome|Intravenous Unfractionated Heparin|"Patients in this arm will receive the standard of care: intravenous unfractionated heparin used as anti-coagulation treatment.~Unfractionated heparin: Intravenous unfractionated heparin used for anticoagulation treatment"
873698|NCT01166997|O1|Outcome|Ultrasound Accelerated Thrombolysis|"Patients in this arm will receive anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System will be used to deliver a low dose <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.~EkoSonic Endovascular System: The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus."
873699|NCT01166997|O2|Outcome|Unfractionated Heprin + EkoSonic Procedure|Patients in this arm received anti-coagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
873700|NCT01166997|O1|Outcome|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
873701|NCT01166997|E2|Reported Event|UFH + EkoSonic|Patients in this arm received anticoagulation (intravenous unfractionated heparin) plus the EkoSonic Endovascular System was used to deliver a low dose of <20mg rt-PA (Actilyse) directly into the occlusive pulmonary thrombus.
873702|NCT01166997|E1|Reported Event|Unfractionated Heparin (UFH) Alone|Patients in this arm received the standard of care: intravenous unfractionated heparin used as anticoagulation treatment.
873703|NCT01166971|B3|Baseline|Total|Total of all reporting groups
873704|NCT01166971|B2|Baseline|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
873705|NCT01166971|B1|Baseline|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
873706|NCT01166971|P2|Participant Flow|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
873707|NCT01166971|P1|Participant Flow|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
873708|NCT01166971|O2|Outcome|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
873709|NCT01166971|O1|Outcome|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
873710|NCT01166971|E2|Reported Event|Tecnis MF|Bilateral Implantation of Tecnis Multifocal Intraocular lenses after cataract extraction
873711|NCT01166971|E1|Reported Event|ReSTOR +3|Bilateral Implantation of ReSTOR +3 Intraocular lenses after cataract extraction
873712|NCT01166958|B3|Baseline|Total|Total of all reporting groups
873713|NCT01166958|B2|Baseline|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
874639|NCT01163955|E1|Reported Event|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
873714|NCT01166958|B1|Baseline|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873715|NCT01166958|P2|Participant Flow|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
873716|NCT01166958|P1|Participant Flow|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873717|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
873718|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873719|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
873720|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873721|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
873722|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873723|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
873724|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873725|NCT01166958|O2|Outcome|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
873726|NCT01166958|O1|Outcome|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873727|NCT01166958|E2|Reported Event|Monthly Cycles of Teriparatide Followed by Raloxifene|"Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.~Raloxifene: Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature."
873728|NCT01166958|E1|Reported Event|Daily Teriparatide (Forteo)|Teriparatide: Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
873729|NCT01166763|B1|Baseline|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
873730|NCT01166763|P1|Participant Flow|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
873731|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
873732|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
873733|NCT01166763|O1|Outcome|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
873734|NCT01166763|E1|Reported Event|High Dose Vitamin D3 (10,000 IU Weekly)|"Group/Cohort Label vitamin D3~vitamin D3: oral capsules, 10,000 IU per week for 6 months"
873735|NCT01166750|B3|Baseline|Total|Total of all reporting groups
873736|NCT01166750|B2|Baseline|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
873770|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873737|NCT01166750|B1|Baseline|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
873738|NCT01166750|P2|Participant Flow|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
873739|NCT01166750|P1|Participant Flow|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
873740|NCT01166750|O2|Outcome|Wait-List Control Group|
873741|NCT01166750|O1|Outcome|CD-ROM Treatment|Jointstrong
873742|NCT01166750|E2|Reported Event|Wait-list Control Group|Wait-list Control Group : Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
873743|NCT01166750|E1|Reported Event|CD-ROM-treatment|"CD-ROM : Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
873744|NCT01166724|B3|Baseline|Total|Total of all reporting groups
873745|NCT01166724|B2|Baseline|Tacrolimus|Patient will stay on Tacrolimus
873746|NCT01166724|B1|Baseline|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
873747|NCT01166724|P2|Participant Flow|Tacrolimus|Patient will stay on Tacrolimus
873748|NCT01166724|P1|Participant Flow|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
873749|NCT01166724|O2|Outcome|Tacrolimus|Patient will stay on Tacrolimus
873750|NCT01166724|O1|Outcome|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
873751|NCT01166724|O2|Outcome|Tacrolimus|Patient will stay on Tacrolimus
873752|NCT01166724|O1|Outcome|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
873753|NCT01166724|E2|Reported Event|Tacrolimus|Patient will stay on Tacrolimus
873754|NCT01166724|E1|Reported Event|Sirolimus|"patients will be switched from Tacrolimus to Sirolimus~Sirolumus: Tacrolimus to Sirolimus~Tacrolimus: dosage per trough level"
873755|NCT01166659|B1|Baseline|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
873756|NCT01166659|P1|Participant Flow|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
873757|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
873758|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
873759|NCT01166659|O1|Outcome|CyPass Micro-Stent|Subjects received the CyPass Micro-Stent
873760|NCT01166659|E2|Reported Event|Ocular Adverse Events|At risk population for ocular adverse events is included with unit of eyes.
873761|NCT01166659|E1|Reported Event|Non-Ocular Adverse Events|At risk population for non-ocular adverse events is included with unit of subjects
873762|NCT01166646|B3|Baseline|Total|Total of all reporting groups
873763|NCT01166646|B2|Baseline|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873764|NCT01166646|B1|Baseline|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873765|NCT01166646|P2|Participant Flow|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873766|NCT01166646|P1|Participant Flow|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873767|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873768|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873769|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
874640|NCT01163916|B4|Baseline|Total|Total of all reporting groups
873771|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873772|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873773|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873774|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873775|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873776|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873777|NCT01166646|O2|Outcome|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873778|NCT01166646|O1|Outcome|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for up to 2 weeks"
873779|NCT01166646|E2|Reported Event|Halobetasol Proprionate Cream 0.05%|"Subjects randomized to receive cream~Halobetasol Proprionate Cream 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
873780|NCT01166646|E1|Reported Event|Halobetasol Proprionate Lotion 0.05%|"Subjects randomized to receive lotion~Halobetasol Proprionate Lotion 0.05%: Apply 3.5 grams twice daily for 1-2 weeks"
873781|NCT01166282|B3|Baseline|Total|Total of all reporting groups
873782|NCT01166282|B2|Baseline|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873783|NCT01166282|B1|Baseline|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873784|NCT01166282|P3|Participant Flow|Open-label Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for up to 192 weeks.
873785|NCT01166282|P2|Participant Flow|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873786|NCT01166282|P1|Participant Flow|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873787|NCT01166282|O3|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
873788|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873789|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873790|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873791|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873792|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873793|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873794|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873795|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873796|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873797|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873798|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873799|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873800|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873801|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873802|NCT01166282|O2|Outcome|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873803|NCT01166282|O1|Outcome|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873804|NCT01166282|E3|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (double-blind or open-label) for up to 204 weeks.
873805|NCT01166282|E2|Reported Event|Double-blind Adalimumab EOW|Adalimumab (body surface area dosing 24 mg/m^2 up to a maximum of 40 mg) every other week (eow) for 12 weeks.
873806|NCT01166282|E1|Reported Event|Double-blind Placebo EOW|Placebo for adalimumab every other week (eow) for 12 weeks.
873807|NCT01166230|B3|Baseline|Total|Total of all reporting groups
873808|NCT01166230|B2|Baseline|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873809|NCT01166230|B1|Baseline|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873810|NCT01166230|P2|Participant Flow|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
873811|NCT01166230|P1|Participant Flow|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PCB305/04 who were followed for recurrence.
875543|NCT01160848|E1|Reported Event|3 Areas Per Patient, 3 Hours|
873812|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873813|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873814|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873815|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873816|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873817|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873818|NCT01166230|O2|Outcome|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873819|NCT01166230|O1|Outcome|Patients With Ta/T1, Randomized to White Light Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873820|NCT01166230|E2|Reported Event|Patients With Ta/T1, Randomized to White Light Cystoscopy|
873821|NCT01166230|E1|Reported Event|Patients With Ta/T1 Randomized to Hexvix Cystoscopy|Patients with non-invasive papillary bladder cancer (Ta/T1), enrolled in the previously completed pivotal phase III study PC B305/04 who were followed for recurrence.
873822|NCT01166178|B3|Baseline|Total|Total of all reporting groups
873823|NCT01166178|B2|Baseline|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873824|NCT01166178|B1|Baseline|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873825|NCT01166178|P2|Participant Flow|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873826|NCT01166178|P1|Participant Flow|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873827|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873828|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873829|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873830|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873831|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873832|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873833|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873834|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873835|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873836|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873837|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873838|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873839|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873840|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873841|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873842|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873843|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873844|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873845|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873846|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873847|NCT01166178|O2|Outcome|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873848|NCT01166178|O1|Outcome|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873849|NCT01166178|E2|Reported Event|Placebo|Participants received placebo to zoledronic acid infusion in addition to calcium and vitamin D
873850|NCT01166178|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid infusion in addition to calcium and vitamin D
873861|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
873862|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
875544|NCT01160822|B8|Baseline|Total|Total of all reporting groups
873851|NCT01166126|B1|Baseline|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
873852|NCT01166126|P1|Participant Flow|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
873853|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
873854|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
873855|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
873856|NCT01166126|O1|Outcome|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period began with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
873857|NCT01166126|E1|Reported Event|Treatment (Temsirolimus and Selumetinib)|"Treatment Phase: This period begins with the first intravenous (through the vein) infusion of TEMSIROLIMUS and the first AZD6244 administration by mouth (visit 2, Week 1) and will continue until Week 8 (Visit 4).~Investigators planned for as many as 38 patients to receive the same dosage of TEMSIROLIMUS injected in the veins once a week for 8 weeks, and the AZD6244 would be given as capsules by mouth twice a day for 8 weeks. That is one cycle. The TEMSIROLIMUS and AZD6244 would be given to participants as an outpatient, unless admission to the hospital was needed for treatment of related side effects or underlying disease. The subsequent cycles of TEMSIROLIMUS and AZD6244 would be given every 8 weeks. The TEMSIROLIMUS would be injected in a vein over 30 minutes.~The continuation phase would begin with visits at weeks 12 in patients who received at least two cycles of treatments."
873858|NCT01165996|B1|Baseline|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
873859|NCT01165996|P1|Participant Flow|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
873860|NCT01165996|O1|Outcome|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
873863|NCT01165996|E1|Reported Event|Arm I|INDUCTION PHASE: Patients receive decitabine subcutaneously (SQ) twice weekly for 4 weeks or thrice weekly until achieving bone marrow blasts < 5%. MAINTENANCE PHASE: Patients then receive decitabine SQ twice weekly for up to 52 weeks in the absence of disease progression or unacceptable toxicity.
873864|NCT01165983|B3|Baseline|Total|Total of all reporting groups
873865|NCT01165983|B2|Baseline|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873866|NCT01165983|B1|Baseline|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873867|NCT01165983|P2|Participant Flow|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873868|NCT01165983|P1|Participant Flow|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873869|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873870|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873871|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873872|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873873|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873874|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873875|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873876|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873877|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873878|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873879|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873880|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873881|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873882|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873883|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873884|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873885|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873886|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873887|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873888|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873889|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873890|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873891|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873892|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873893|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873894|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873895|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873896|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873897|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873898|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873899|NCT01165983|O2|Outcome|T2DM Patients|
873900|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
873901|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873902|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873903|NCT01165983|O2|Outcome|T2DM Patients|
873904|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
873905|NCT01165983|O2|Outcome|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873906|NCT01165983|O1|Outcome|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873907|NCT01165983|O2|Outcome|T2DM Patients|
873908|NCT01165983|O1|Outcome|Subjects at Risk of DMII|
873909|NCT01165983|E2|Reported Event|Aliskiren|Aliskiren: 150mg tablet, taken orally for 12 weeks daily
873910|NCT01165983|E1|Reported Event|Placebo|Placebo: 0mg tablet, taken orally for 12 weeks daily
873911|NCT01165840|B1|Baseline|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
873912|NCT01165840|P1|Participant Flow|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
873913|NCT01165840|O1|Outcome|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
873914|NCT01165840|E1|Reported Event|Dapsone|"Dapsone 100 mg PO x 1 dose~Dapsone: 100 mg PO x 1 dose"
873915|NCT01165775|B1|Baseline|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.~Data are available for 15 of 17 participants."
873916|NCT01165775|P1|Participant Flow|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
873917|NCT01165775|O3|Outcome|Neonates With Unknown Hypoglycemia Status|Neonates with unknown hypoglycemia status from birth to hospital discharge.
873918|NCT01165775|O2|Outcome|Neonates Without Hypoglycemia|Neonates without hypoglycemia from birth to hospital discharge.
873919|NCT01165775|O1|Outcome|Neonates With Hypoglycemia|Neonates with hypoglycemia from birth to hospital discharge.
874221|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
873920|NCT01165775|O2|Outcome|Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
873921|NCT01165775|O1|Outcome|Non-Diabetic Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
873922|NCT01165775|E1|Reported Event|Threatened Pre Term Labor Patients|"Patients receiving betamethasone to minimize the complications of prematurity will monitor blood glucose levels using the Dexcom Seven Plus Continuous Glucose Monitoring System.~Dexcom Seven Plus Continuous Glucose Monitoring System: Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter."
873923|NCT01165684|B3|Baseline|Total|Total of all reporting groups
873924|NCT01165684|B2|Baseline|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873925|NCT01165684|B1|Baseline|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873926|NCT01165684|P2|Participant Flow|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873927|NCT01165684|P1|Participant Flow|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873928|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873929|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873930|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873931|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873932|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873933|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873934|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873935|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873936|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873937|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873938|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
874179|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
873939|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873940|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873941|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873942|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873943|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873944|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873945|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873946|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873947|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873948|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873949|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873950|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873951|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873952|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873953|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873954|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873955|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873956|NCT01165684|O2|Outcome|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873957|NCT01165684|O1|Outcome|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
874982|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
873958|NCT01165684|E2|Reported Event|Basal-bolus|In addition to insulin detemir once daily, insulin aspart was added before each of the main meals (breakfast, lunch and dinner) starting at the randomisation visit. Subjects on pre-trial metformin and pioglitazone continued their medication.
873959|NCT01165684|E1|Reported Event|Step-wise|In addition to insulin detemir once daily, insulin aspart was added step-wise starting at the randomisation visit (Week 0) with the first bolus before the largest meal, followed by a second bolus at the second largest meal at Week 11 in subjects with HbA1c ≥ 7.0% at Week 10, and a second or third bolus at Week 22 in subjects with HbA1c ≥ 7.0% at Week 21. Subjects on pre-trial metformin and pioglitazone continued their medication.
873960|NCT01165554|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
873961|NCT01165554|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
873962|NCT01165554|O1|Outcome|Specificity-Normal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
873963|NCT01165554|O1|Outcome|Sensitivity-Abnormal Visual Reads|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
873964|NCT01165554|O1|Outcome|Specificity Percentage of Normal Visual Reads|
873965|NCT01165554|O1|Outcome|Sensitivity Percentage of Abnormal Visual Reads|
873966|NCT01165554|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10 microgram (ug) flutemetamol). The nominal activity of a single administration of [18F]flutemetamol was 185 to 370 megabecquerels (MBq).
873967|NCT01165541|B1|Baseline|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg) for 7 weeks.
873968|NCT01165541|P1|Participant Flow|Entire Study Population|Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d first for 7 weeks; then Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg) for 7 weeks.
873969|NCT01165541|O2|Outcome|Quetiapine XR Plus Mirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR plus mirtazapine: Quetiapine fumarate extended release (50-400mg) plus mirtazapine (7.5-45mg)"
873970|NCT01165541|O1|Outcome|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
873971|NCT01165541|E2|Reported Event|Quetiapine XR andMirtazapine|"Quetiapine XR 50-400mg + Mirtazapine 7.5-45mg~Quetiapine XR and mirtazapine: Quetiapine fumarate extended release (50-400mg) and mirtazapine (7.5-45mg)"
873972|NCT01165541|E1|Reported Event|Quetiapine Fumarate Extended Release (Quetiapine XR)|"Quetiapine XR 50-400mg~Quetiapine fumarate extended release (Quetiapine XR): Quetiapine fumarate extended release 50-400mg/d"
873973|NCT01165450|B1|Baseline|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873974|NCT01165450|P1|Participant Flow|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873975|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873976|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873977|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873978|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873979|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873980|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873981|NCT01165450|O1|Outcome|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
873982|NCT01165450|E1|Reported Event|Overall Study|We enrolled three patients and randomized and treated two patients in the first cohort. On October 24, 2012 we were notified by David Eisenbud, MD (Chief Medical Officer, CoDa Therapeutics, Inc) that our supply of low dose study drug was expired and no more would be produced by the drug manufacturer.
874074|NCT01165242|O1|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
873983|NCT01165424|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
873984|NCT01165424|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
873985|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
873986|NCT01165424|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
873987|NCT01165424|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg device.~Participants aged 3 to 11 years received one spray per nostril once daily (100 mcg/day) in the morning for up to 24 weeks.~Participants aged 12 to 15 years received 2 sprays per nostril once daily (200 mcg/day) in the morning for up to 24 weeks."
873988|NCT01165320|B3|Baseline|Total|Total of all reporting groups
873989|NCT01165320|B2|Baseline|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
873990|NCT01165320|B1|Baseline|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
873991|NCT01165320|P3|Participant Flow|Participants With Esophageal Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 7 and 28 days, respectively.
873992|NCT01165320|P2|Participant Flow|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
873993|NCT01165320|P1|Participant Flow|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
873994|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
873995|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
873996|NCT01165320|O2|Outcome|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively
873997|NCT01165320|O1|Outcome|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively
873998|NCT01165320|E2|Reported Event|Participants With Aspergillosis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 84 days, respectively.
873999|NCT01165320|E1|Reported Event|Participants With Invasive Candidiasis|MK-0991 therapy as a single loading dose of 70 mg/m^2 intravenously on Day 1 (maximum not to exceed 70 mg), followed by 50 mg/m^2 as a single once-daily dose on all subsequent days (maximum of 70 mg daily). The minimum and maximum treatment duration was 14 and 56 days, respectively.
874000|NCT01165307|B3|Baseline|Total|Total of all reporting groups
874001|NCT01165307|B2|Baseline|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874002|NCT01165307|B1|Baseline|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874003|NCT01165307|P2|Participant Flow|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874075|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874004|NCT01165307|P1|Participant Flow|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874005|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874006|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874007|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874008|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874009|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874010|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874011|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874012|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874013|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874014|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874015|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874016|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874017|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874018|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874076|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874983|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874019|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874020|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874021|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874022|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874023|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874024|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874025|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874026|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874027|NCT01165307|O2|Outcome|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874028|NCT01165307|O1|Outcome|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874029|NCT01165307|E2|Reported Event|Radiofrequency Endometrial Ablation|Subjects will undergo NovaSure® radiofrequency endometrial ablation within 4 weeks of randomization. The procedure will occur at any time during the menstrual cycle, without endometrial pre-treatment. Endometrial thinning will be carried out using suction curettage in 50% of the cases included in the ablation group. Random assignment for this treatment will be included in the overall randomization plan.
874030|NCT01165307|E1|Reported Event|Medical Therapy|Subjects will be prescribed monthly packets of Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills. Subjects who are unable to tolerate oral contraceptive pills or are unwilling to take oral contraceptive pills will be prescribed naproxen sodium pills. The latter will be administered as follows; 500mg with onset of menses, then 250mg three times daily for the duration of the menses (or maximum of five days).
874031|NCT01165281|B3|Baseline|Total|Total of all reporting groups
874032|NCT01165281|B2|Baseline|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874033|NCT01165281|B1|Baseline|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874034|NCT01165281|P2|Participant Flow|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874035|NCT01165281|P1|Participant Flow|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874036|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874037|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874038|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874039|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874040|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874041|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874077|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874181|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874042|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874043|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874044|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874045|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874046|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874047|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874048|NCT01165281|O2|Outcome|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874049|NCT01165281|O1|Outcome|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874078|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874180|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874050|NCT01165281|E2|Reported Event|Oxycodone Controlled-release (CR) Oral Tablets|Patients received oxycodone controlled-release (CR) 5 to 40 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874051|NCT01165281|E1|Reported Event|Tapentadol (JNS024) Extended-release (ER) Oral Tablets|Patients received tapentadol (ER) 25 to 200 mg twice daily for 4 weeks. During the titration period, the dose was titrated to the individual’s optimal dose balancing efficacy and tolerability until sufficient analgesia was attained. Patients were eligible to formally enter the maintenance period if they had a pain intensity score of <=3 and did not take rescue medication more than twice daily while they were taking a stable regimen of study drug (6 identical consecutive doses) over a 3-day period. During the maintenance period, patients continued to take their optimized dose of study drug achieved during the titration period. Dosage adjustments of study drug were allowed during the titration and maintenance periods, with the exception of the last 3 days of the maintenance period when the dose was to remain unchanged.
874052|NCT01165242|B4|Baseline|Total|Total of all reporting groups
874053|NCT01165242|B3|Baseline|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874054|NCT01165242|B2|Baseline|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874055|NCT01165242|B1|Baseline|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874056|NCT01165242|P3|Participant Flow|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874057|NCT01165242|P2|Participant Flow|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874058|NCT01165242|P1|Participant Flow|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874059|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874060|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874061|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874062|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874063|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874064|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874065|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874066|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874067|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874068|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874069|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874070|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874071|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874072|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874073|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
892132|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
874079|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874080|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874081|NCT01165242|O3|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874082|NCT01165242|O2|Outcome|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874083|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874084|NCT01165242|O2|Outcome|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874085|NCT01165242|O1|Outcome|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874086|NCT01165242|E3|Reported Event|Menactra Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874087|NCT01165242|E2|Reported Event|Nimenrix Lot B Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874088|NCT01165242|E1|Reported Event|Nimenrix Lot A Group|Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
874089|NCT01165216|B3|Baseline|Total|Total of all reporting groups
874090|NCT01165216|B2|Baseline|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874091|NCT01165216|B1|Baseline|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874092|NCT01165216|P2|Participant Flow|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874093|NCT01165216|P1|Participant Flow|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874094|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2 , administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30 -60 minutes every 3 weeks (up to 6 doses).
874095|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874096|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874097|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874098|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874099|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874100|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874101|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874102|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874103|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874104|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874105|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874106|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874107|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874108|NCT01165216|O2|Outcome|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses) and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874109|NCT01165216|O1|Outcome|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874110|NCT01165216|E2|Reported Event|Dose Level 2: Ipilimumab, 10 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 10 mg/kg, administered as a single dose IV over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, AUC=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874111|NCT01165216|E1|Reported Event|Dose Level 1: Ipilimumab, 3 mg/kg + Paclitaxel + Carboplatin|Participants received ipilimumab, 3 mg/kg, administered as a single dose intravenously (IV) over 90 minutes every 3 weeks, plus paclitaxel, 175 mg/m^2, administered as a single dose IV over 3 hours every 3 weeks (up to 6 doses), and carboplatin, area under the concentration curve (AUC)=6, administered as a single dose IV over 30-60 minutes every 3 weeks (up to 6 doses).
874112|NCT01165203|B3|Baseline|Total|Total of all reporting groups
874113|NCT01165203|B2|Baseline|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874114|NCT01165203|B1|Baseline|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874115|NCT01165203|P2|Participant Flow|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874116|NCT01165203|P1|Participant Flow|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874117|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874118|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874119|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874120|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874121|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874122|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874123|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874124|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874125|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874126|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874127|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874128|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874129|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874130|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874131|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874132|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874133|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874134|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874135|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874136|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874137|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874138|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874139|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874140|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874141|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874142|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874143|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874144|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874145|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874146|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874147|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874148|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874149|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874150|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
877054|NCT01155830|P1|Participant Flow|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
874151|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874152|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874153|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874154|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874155|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874156|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874157|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874158|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874159|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874160|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874161|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874162|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874163|NCT01165203|O6|Outcome|Non-ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874164|NCT01165203|O5|Outcome|Non-ART High CD4 Cohort - GSK 1437173A|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874165|NCT01165203|O4|Outcome|ART Low CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874166|NCT01165203|O3|Outcome|ART Low CD4 Cohort - GSK 1437173A|ART-treated subjects with a low CD4 T-cells count: 50-199 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874167|NCT01165203|O2|Outcome|ART High CD4 Cohort - Placebo|ART-naïve HIV-infected subjects with a high CD4 T-cells count of ≥ 500 cells/mm3, receiving three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874168|NCT01165203|O1|Outcome|Antiretroviral Therapy (ART) High CD4 Cohort - GSK 1437173A|ART-treated subjects with a high CD4 T-cells count: ≥ 200 cells/mm3, receiving three doses of GSK 1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874169|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874170|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874171|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874172|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874173|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874174|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874175|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874176|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874177|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874178|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
877277|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
874182|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874183|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874184|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874185|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874186|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874187|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874188|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874189|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874190|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874191|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874192|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874193|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874194|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of gE/AS01B vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874195|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874196|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874197|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874198|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874199|NCT01165203|O2|Outcome|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874200|NCT01165203|O1|Outcome|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874201|NCT01165203|E2|Reported Event|Placebo Group|Subjects who received three doses of placebo (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874202|NCT01165203|E1|Reported Event|GSK1437173A Group|Subjects who received three doses of GSK1437173A vaccine (Months 0, 2 and 6), administered intramuscularly, in the deltoid muscle of the non-dominant arm.
874203|NCT01165177|B3|Baseline|Total|Total of all reporting groups
874204|NCT01165177|B2|Baseline|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874205|NCT01165177|B1|Baseline|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874206|NCT01165177|P2|Participant Flow|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874207|NCT01165177|P1|Participant Flow|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874208|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874209|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874210|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874211|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874212|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874213|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874214|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874215|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874216|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874217|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874218|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874219|NCT01165177|O1|Outcome|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874220|NCT01165177|O2|Outcome|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
877278|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
874222|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874223|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874224|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874225|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874226|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874227|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874228|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874229|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874230|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874231|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874232|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874233|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874234|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874235|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874236|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874237|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874238|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874239|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874240|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874241|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874242|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874243|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874244|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874245|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874246|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874247|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874248|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874249|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874250|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874251|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874252|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874253|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874254|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874255|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874256|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874257|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874258|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874259|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874260|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874261|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874262|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
877279|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
874263|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874264|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874265|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874266|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874267|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874268|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874269|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874270|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874271|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874272|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874273|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874274|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874275|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874276|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874277|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874278|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874279|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874280|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874281|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874282|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874283|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874284|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874285|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874286|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874287|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874288|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874289|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874290|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874291|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874292|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874293|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874294|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874295|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874296|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874297|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874298|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874299|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874300|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874301|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874302|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874303|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
877280|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
874304|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874305|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874306|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874307|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874308|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874309|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874310|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874311|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874312|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874313|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874314|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874315|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874316|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874317|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874318|NCT01165177|O8|Outcome|Placebo Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874319|NCT01165177|O7|Outcome|Placebo Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874320|NCT01165177|O6|Outcome|Placebo 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874321|NCT01165177|O5|Outcome|Placebo 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving placebo according to a 0, 2-month schedule.
874322|NCT01165177|O4|Outcome|GSK1437173A Overall Ages Group|Subjects aged over 50 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874323|NCT01165177|O3|Outcome|GSK1437173A Over 70 YOA Group|Subjects aged above 70 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874324|NCT01165177|O2|Outcome|GSK1437173A 60-69 YOA Group|Subjects aged between 60 and 69 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874325|NCT01165177|O1|Outcome|GSK1437173A 50-59 YOA Group|Subjects aged between 50 and 59 years of age (YOA), receiving the GSK1437173A vaccine according to a 0, 2-month schedule.
874326|NCT01165177|E2|Reported Event|Placebo Group|Subjects received saline solution (NaCl solution) as control according to a 0, 2-month schedule.
874327|NCT01165177|E1|Reported Event|GSK1437173A Group|Subjects received herpes zoster subunit vaccine (gE/AS01B vaccine: GSK1437173A) according to a 0, 2-month schedule.
874328|NCT01165138|B4|Baseline|Total|Total of all reporting groups
874329|NCT01165138|B3|Baseline|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874330|NCT01165138|B2|Baseline|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874331|NCT01165138|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874332|NCT01165138|P4|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874333|NCT01165138|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874334|NCT01165138|P2|Participant Flow|Placebo|Participants (par.) received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874335|NCT01165138|P1|Participant Flow|Current Anti-asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) for 4 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
874336|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874337|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874338|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874339|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874340|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874341|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874342|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874343|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874344|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874345|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874346|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874347|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874348|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874349|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874350|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874351|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874352|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874353|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874354|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874355|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874356|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874357|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874358|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874359|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874360|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874361|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874362|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874363|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874364|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874365|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874366|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874367|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874368|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874369|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874370|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874371|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874372|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874373|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874374|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874375|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874376|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874377|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874378|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874379|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874380|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874381|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874382|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874383|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874384|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874385|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874386|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874387|NCT01165138|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874388|NCT01165138|O2|Outcome|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874389|NCT01165138|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874390|NCT01165138|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/Vilanterol (VI) 100/25 µg inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874391|NCT01165138|E2|Reported Event|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 microgram (µg) inhalation powder OD in the evening from the DPI for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874392|NCT01165138|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) for 12 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
874393|NCT01165112|B1|Baseline|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
874394|NCT01165112|P1|Participant Flow|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
874395|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
874396|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
874397|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
874398|NCT01165112|O1|Outcome|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
874399|NCT01165112|E1|Reported Event|Treatment (Chemotherapy and Monoclonal Antibody Therapy)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60 minutes on days 1-3, and carboplatin IV over 60 minutes on day 1. Patients with CD20+ T-cell lymphoma disease also receive rituximab IV on day 2 or 3. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Carboplatin: Given IV~Rituximab: Given IV~Etoposide: Given IV~Laboratory Biomarker Analysis: Correlative studies"
874400|NCT01165047|B1|Baseline|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
874401|NCT01165047|P1|Participant Flow|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
874402|NCT01165047|O1|Outcome|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
874403|NCT01165047|E1|Reported Event|Nitric Oxide|"80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM~Nitric Oxide: Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM."
874404|NCT01165021|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874405|NCT01165021|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874641|NCT01163916|B3|Baseline|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874406|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874407|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874408|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874409|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874410|NCT01165021|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874411|NCT01165021|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles~Cisplatin: 75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles"
874412|NCT01164891|B1|Baseline|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874413|NCT01164891|P1|Participant Flow|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 milligrams (mg) orally two times daily (BID) from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874414|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874415|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874416|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874417|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15 participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874418|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874419|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874420|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874421|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874422|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874423|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874424|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874425|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874426|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874427|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874428|NCT01164891|O1|Outcome|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874429|NCT01164891|E1|Reported Event|14C-labeled RO5185426|Participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID from Day 1 to Day 14. On Day 15, participants received a single dose of 960 mg RO5185426 with a maximum of 2.56 millibecquerel (69.2 microcurie) of 14C RO5185426. After Day 15, participants received non-labeled RO5185426 film-coated tablets 960 mg orally BID until the development of progressive disease, unacceptable toxicity, consent withdrawal, death, lost to follow-up or any other criteria for removal as determined by the investigator.
874430|NCT01164865|B3|Baseline|Total|Total of all reporting groups
874431|NCT01164865|B2|Baseline|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
874432|NCT01164865|B1|Baseline|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
874433|NCT01164865|P2|Participant Flow|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
874434|NCT01164865|P1|Participant Flow|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
874435|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
874436|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
874437|NCT01164865|O2|Outcome|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
874438|NCT01164865|O1|Outcome|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
874439|NCT01164865|E2|Reported Event|Clear Care|Clear Care contact lens care system used with study contact lenses on a daily basis for 2 weeks.
874440|NCT01164865|E1|Reported Event|OPTI-FREE RepleniSH|OPTI-FREE RepleniSH multipurpose disinfecting solution used with study contact lenses on a daily basis for 2 weeks.
874441|NCT01164722|B3|Baseline|Total|Total of all reporting groups
874442|NCT01164722|B2|Baseline|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
874443|NCT01164722|B1|Baseline|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874444|NCT01164722|P2|Participant Flow|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
892133|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
874445|NCT01164722|P1|Participant Flow|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874446|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
874447|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874448|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
874449|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874450|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
874451|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874452|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
874453|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874454|NCT01164722|O2|Outcome|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
874455|NCT01164722|O1|Outcome|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874456|NCT01164722|E2|Reported Event|Arm II: Expectant Management|"Patients receive standard of care and undergo clinical observation. After 12 months, patients may receive IRC ablation to all anal intraepithelial neoplasia lesions despite of their size.~clinical observation: Patients undergo observation"
874457|NCT01164722|E1|Reported Event|Arm I: Infrared Coagulator Treatment|"Infrared photocoagulation therapy. The infrared coagulator (IRC) contact tip is placed in direct contact with lesion under high-resolution anoscopy (HRA) guidance. Patients then undergo IRC ablation for 1.5 second pulses. IRC ablation is reapplied until the level of submucosal vessels are reached.~infrared photocoagulation therapy: Anal infrared coagulator ablation"
874458|NCT01164644|B3|Baseline|Total|Total of all reporting groups
874459|NCT01164644|B2|Baseline|Placebo|The subject will take twelve pills by mouth three times a day over four days.
874460|NCT01164644|B1|Baseline|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
874461|NCT01164644|P2|Participant Flow|Placebo|The subject will take twelve pills by mouth three times a day over four days.
874462|NCT01164644|P1|Participant Flow|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
874463|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
874464|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
874465|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
874466|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
874467|NCT01164644|O2|Outcome|Placebo|The subject will take twelve pills by mouth three times a day over four days.
874468|NCT01164644|O1|Outcome|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
874469|NCT01164644|E2|Reported Event|Placebo|The subject will take twelve pills by mouth three times a day over four days.
874470|NCT01164644|E1|Reported Event|Arnica Montana|The subject will take twelve pills by mouth three times a day over four days.
874471|NCT01164579|B4|Baseline|Total|Total of all reporting groups
874472|NCT01164579|B3|Baseline|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874984|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874473|NCT01164579|B2|Baseline|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874474|NCT01164579|B1|Baseline|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874475|NCT01164579|P3|Participant Flow|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874476|NCT01164579|P2|Participant Flow|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874477|NCT01164579|P1|Participant Flow|Tofacitinib (CP-690,550) Plus Methotrexate (MTX)|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874478|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874479|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874480|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874481|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874482|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874557|NCT01164501|P3|Participant Flow|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
874558|NCT01164501|P2|Participant Flow|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
892134|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
874483|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874484|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874485|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874486|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874487|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874488|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874489|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874490|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874491|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874492|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874559|NCT01164501|P1|Participant Flow|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
874560|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
874561|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
892135|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
874493|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874494|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874495|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874496|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874497|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874498|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874499|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874500|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874501|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874502|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874562|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
874563|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
874564|NCT01164501|O1|Outcome|Placebo|Placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
877281|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
874503|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874504|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 milligrams (mg), tablets, orally (PO), twice daily (BID), and MTX 10 mg per week (mg/week) to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874505|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874506|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874507|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874508|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874509|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874510|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874511|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874512|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874565|NCT01164501|O3|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
874566|NCT01164501|O2|Outcome|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
874567|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
874513|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874514|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874515|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874516|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874517|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874518|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874519|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874520|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874521|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874522|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874568|NCT01164501|O2|Outcome|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
874569|NCT01164501|O1|Outcome|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
874570|NCT01164501|E3|Reported Event|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
892136|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
874523|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874524|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874525|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874526|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874527|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874528|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874529|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874530|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874531|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874532|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874571|NCT01164501|E2|Reported Event|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
874572|NCT01164501|E1|Reported Event|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
874573|NCT01164475|B3|Baseline|Total|Total of all reporting groups
874642|NCT01163916|B2|Baseline|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874533|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874534|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874535|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874536|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874537|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874538|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874539|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874540|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874541|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874542|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874614|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874615|NCT01164137|E2|Reported Event|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874543|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874544|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874545|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874546|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874547|NCT01164579|O3|Outcome|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874548|NCT01164579|O2|Outcome|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874549|NCT01164579|O1|Outcome|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874550|NCT01164579|E3|Reported Event|Methotrexate|Participants received MTX 10 mg/week to 20 mg/week, capsules, PO, and matching placebo CP-690,550 tablets, PO, BID. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874551|NCT01164579|E2|Reported Event|Tofacitinib (CP-690,550)|Participants received CP-690,550 10 mg tablets, PO, BID and matching placebo MTX capsules, PO, once weekly for a maximum of 12 months. To maintain the blind, matching placebo MTX was titrated as follows: 4 capsules once weekly for 4 weeks; if well tolerated, at Month 1 titrate up to 6 capsules once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 8 capsules once weekly for the duration of the study. A single dose reduction of MTX placebo to 2 capsules was allowed because of lack of tolerance, as long as the participant remained on a dose of at least 4 MTX placebo capsules weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874552|NCT01164579|E1|Reported Event|Tofacitinib (CP-690,550) Plus MTX|Participants received CP-690,550 10 mg, tablets, PO, BID, and MTX 10 mg/week to 20 mg/week, capsules, PO, for a maximum of 12 months. MTX dose was titrated as follows: 10 mg once weekly for 4 weeks; if well tolerated, then at Month 1 titrate up to 15 mg once weekly for 4 weeks; if well tolerated, then at Month 2 titrate up to 20 mg once weekly for the duration of the study. A single dose reduction of MTX 5 mg was allowed because of lack of tolerance, as long as the participant remained on a dose of at least MTX 10 mg weekly. Participants also received folate supplementation according to local MTX label guidelines and standard of care.
874553|NCT01164501|B4|Baseline|Total|Total of all reporting groups
874554|NCT01164501|B3|Baseline|Empa 25mg|Single oral dose of empagliflozin (empa) 25mg plus a placebo tablet matching the 10mg empa dose were taken once daily for 52 weeks.
874555|NCT01164501|B2|Baseline|Empa 10mg|Single oral dose of empagliflozin (empa) 10mg plus a placebo tablet matching the 25mg empa dose were taken once daily for 52 weeks.
874556|NCT01164501|B1|Baseline|Placebo|Placebo tablets, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 52 weeks.
874574|NCT01164475|B2|Baseline|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874575|NCT01164475|B1|Baseline|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874576|NCT01164475|P2|Participant Flow|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874577|NCT01164475|P1|Participant Flow|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (greater than or equal to [>=] 5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874578|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874579|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874580|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874581|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874582|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874583|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874616|NCT01164137|E1|Reported Event|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874643|NCT01163916|B1|Baseline|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874985|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874584|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874585|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874586|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874587|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874588|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874589|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874590|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874591|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874592|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874593|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874594|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874595|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874596|NCT01164475|O2|Outcome|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874597|NCT01164475|O1|Outcome|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874598|NCT01164475|E2|Reported Event|Weight-Based Plerixafor|G-CSF 10 mcg/kg SC injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by plerixafor 0.24 milligram per kilogram (mg/kg) SC injection (weight-based dose) in evening of Day 4 (10 to 11 hours before first apheresis), and then G-CSF 10 mcg/kg SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of CD34+ stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874599|NCT01164475|E1|Reported Event|Fixed Dose Plerixafor|10 microgram per kilogram (mcg/kg) granulocyte-colony stimulating factor (G-CSF) subcutaneous (SC) injection once daily in morning from Day 1 through Day 4 (G-CSF mobilization period), followed by 20 milligram (mg) plerixafor SC injection (fixed dose) in evening of Day 4 (10 to 11 hours prior to first apheresis), and then 10 mcg/kg G-CSF SC injection in morning of Day 5 (1 hour prior to first apheresis). Apheresis process and treatment with plerixafor (10 to 11 hours prior to apheresis) and G-CSF (1 hour prior to apheresis) was continued until the target number of cluster of differentiation 34 (CD34+) stem cells (>=5*10^6 cells/kg) was collected or until a maximum 4 apheresis sessions occurred.
874600|NCT01164137|B3|Baseline|Total|Total of all reporting groups
874601|NCT01164137|B2|Baseline|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874602|NCT01164137|B1|Baseline|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874603|NCT01164137|P2|Participant Flow|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874604|NCT01164137|P1|Participant Flow|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874605|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874606|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874607|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874608|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874609|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874610|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874611|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874612|NCT01164137|O1|Outcome|Experimental: Medication Reconciliation Intervention|Medication Reconciliation : Participants receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874613|NCT01164137|O2|Outcome|Control: Medication Reconciliation Non-Intervention|Medication Reconciliation : Participants not receiving a pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
874638|NCT01163955|E2|Reported Event|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
874617|NCT01164007|B1|Baseline|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874618|NCT01164007|P1|Participant Flow|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 milligrams per square meter (mg/m^2) via intravenous (IV) infusion on Day 1 and bevacizumab as 10 milligrams per kilogram (mg/kg) via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874619|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874620|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874621|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874622|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874623|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874624|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874625|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874626|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874627|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874628|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874629|NCT01164007|O1|Outcome|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874630|NCT01164007|E1|Reported Event|Dacarbazine + Bevacizumab|Participants with unresectable/metastatic melanoma not previously treated with chemotherapy for metastatic disease received dacarbazine as 800 mg/m^2 via IV infusion on Day 1 and bevacizumab as 10 mg/kg via IV infusion on Days 1 and 14 of each 28-day cycle. Treatment continued until disease progression, unacceptable toxicity, participant withdrawal, or physician decision to discontinue.
874631|NCT01163955|B3|Baseline|Total|Total of all reporting groups
874632|NCT01163955|B2|Baseline|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
874633|NCT01163955|B1|Baseline|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
874634|NCT01163955|P2|Participant Flow|Sitting on the Floor 5 Minutes|Sitting on the floor without back support, crossed leg style
874635|NCT01163955|P1|Participant Flow|Sitting in a Chair 5 Minutes|Sitting in a chair with back support and feet flat on the ground
874636|NCT01163955|O2|Outcome|Postural Score Sitting in a Chair After 5 Minutes|Children sat in a chair for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
874637|NCT01163955|O1|Outcome|Postural Score Sitting on Floor After 5 Minutes|Children sat on the floor for five minutes while playing a video game. No intervention (verbal or non-verbal) was given to them.
877282|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
874644|NCT01163916|P3|Participant Flow|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874645|NCT01163916|P2|Participant Flow|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874646|NCT01163916|P1|Participant Flow|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874647|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874648|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874649|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874650|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874651|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874652|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874653|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874654|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874655|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874656|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874657|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874658|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874659|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874660|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874661|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874662|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874663|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874664|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874665|NCT01163916|O4|Outcome|Missing|Participants for whom acceptability data were not available.
874666|NCT01163916|O3|Outcome|Need Assistance|Participants who were unable to self-inject.
874667|NCT01163916|O2|Outcome|Not Convenient|"Participants who described the acceptability of adalimumab injections as not convenient."
874668|NCT01163916|O1|Outcome|Convenient|"Participants who described the acceptability of adalimumab injections as convenient."
874669|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874670|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874671|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874672|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874673|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874674|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874675|NCT01163916|O3|Outcome|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874676|NCT01163916|O2|Outcome|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874677|NCT01163916|O1|Outcome|Rheumatoid Arthritis|Patients with rheumatoid arthritis, prescribed adalimumab as part of routine clinical care in Russia.
874678|NCT01163916|E3|Reported Event|Ankylosing Spondylitis|Patients with ankylosing spondylitis prescribed adalimumab as part of routine clinical care in Russia.
874679|NCT01163916|E2|Reported Event|Psoriatic Arthritis|Patients with psoriatic arthritis prescribed adalimumab as part of routine clinical care in Russia.
874680|NCT01163916|E1|Reported Event|Rheumatoid Arthritis|Patients with rheumatoid arthritis prescribed adalimumab as part of routine clinical care in Russia.
874681|NCT01163851|B3|Baseline|Total|Total of all reporting groups
874682|NCT01163851|B2|Baseline|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874683|NCT01163851|B1|Baseline|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874684|NCT01163851|P2|Participant Flow|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874685|NCT01163851|P1|Participant Flow|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874686|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874687|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874688|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874689|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874690|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874691|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874692|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874693|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874694|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874695|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874696|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874697|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874698|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874699|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874700|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874701|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874826|NCT01163617|O1|Outcome|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C)
892137|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
874702|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874703|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874704|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874705|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874706|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874707|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874708|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874709|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874710|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874711|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874712|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874713|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874714|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874715|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874716|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874717|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874718|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874784|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874719|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874720|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874721|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874722|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874723|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874724|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874725|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874726|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874727|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874728|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874729|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874730|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874731|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874732|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874733|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874734|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874735|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874827|NCT01163617|O2|Outcome|Physiolis Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
874736|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874737|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874738|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874739|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874740|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874741|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874742|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874743|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874744|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874745|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874746|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874747|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874748|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874749|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874750|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874751|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874752|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874785|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874753|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874754|NCT01163851|O2|Outcome|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874755|NCT01163851|O1|Outcome|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874756|NCT01163851|E2|Reported Event|Atorvastatin + PF-04950615 (RN316) 0.5 mg/kg|Atorvastatin tablet 40 mg orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 0.5 mg/kg over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874757|NCT01163851|E1|Reported Event|Atorvastatin + PF-04950615 (RN316) 4 mg/kg|Atorvastatin tablet 40 milligram (mg) orally once daily from Day 1 to Day 7 administered by sponsor, along with PF-04950615 (RN316) 4 milligram/kilogram (mg/kg) over 60 minutes intravenous infusion on Day 4 during treatment phase. Participants were on self administered chronic stable background atorvastatin therapy, 40 mg once daily prior to, and after treatment phase.
874758|NCT01163760|B1|Baseline|Overall|Total number of completed participants are included in baseline measurements.
874759|NCT01163760|P4|Participant Flow|Ocufilcon D First, Then Ocufilcon D|Ocufilcon D contact lenses worn for both periods.
874760|NCT01163760|P3|Participant Flow|Etafilcon A First, Then Etafilcon A|etafilcon A contact lenses worn for both periods.
874761|NCT01163760|P2|Participant Flow|Ocufilcon D First, Then Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
874762|NCT01163760|P1|Participant Flow|Etafilcon A First, Then Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
874763|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
874764|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
874765|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
874766|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
874767|NCT01163760|O2|Outcome|Ocufilcon D|ocufilcon D contact lenses worn in either the first or second period.
874768|NCT01163760|O1|Outcome|Etafilcon A|etafilcon A contact lenses worn in either the first or second period.
874769|NCT01163760|E4|Reported Event|Oculfilcon D / Ocufilcon D|ocufilcon D contact lenses worn first and second period.
874770|NCT01163760|E3|Reported Event|Etafilcon A/ Etafilcon A|etafilcon A contact lenses worn first and second period.
874771|NCT01163760|E2|Reported Event|Ocufilcon D / Etafilcon A|ocufilcon D contact lenses worn first,etafilcon A contact lenses worn second.
874772|NCT01163760|E1|Reported Event|Etafilcon A/ Ocufilcon D|etafilcon A contact lenses worn first,ocufilcon D contact lenses worn second
874773|NCT01163747|B3|Baseline|Total|Total of all reporting groups
874774|NCT01163747|B2|Baseline|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874775|NCT01163747|B1|Baseline|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874776|NCT01163747|P2|Participant Flow|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874777|NCT01163747|P1|Participant Flow|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874778|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874779|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874780|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874781|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874782|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874783|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874786|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874787|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874788|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874789|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874790|NCT01163747|O2|Outcome|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874791|NCT01163747|O1|Outcome|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874792|NCT01163747|E2|Reported Event|Tocilizumab + Methotrexate|Participants received 8 mg/kg tocilizumab intravenously at Baseline (Day 1) and every 4 weeks up to Week 20, in addition to their standard dose of methotrexate. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874793|NCT01163747|E1|Reported Event|Methotrexate|Participants continued to receive their standard dose of methotrexate up to Week 8. From Week 8 participants also received 8 mg/kg tocilizumab intravenously every 4 weeks until Week 20. At Week 3 participants received both pneumococcal and tetanus toxoid vaccinations.
874794|NCT01163721|B3|Baseline|Total|Total of all reporting groups
874795|NCT01163721|B2|Baseline|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
874796|NCT01163721|B1|Baseline|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
874797|NCT01163721|P2|Participant Flow|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
874798|NCT01163721|P1|Participant Flow|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
874799|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
874800|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
874801|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
874802|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
874803|NCT01163721|O2|Outcome|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
874804|NCT01163721|O1|Outcome|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
874805|NCT01163721|E2|Reported Event|Placebo|Participants were randomized to receive placebo to match ranolazine for 12 weeks.
874806|NCT01163721|E1|Reported Event|Ranolazine|Participants were randomized to receive ranolazine for 12 weeks.
874807|NCT01163656|B3|Baseline|Total|Total of all reporting groups
874808|NCT01163656|B2|Baseline|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
874809|NCT01163656|B1|Baseline|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
874810|NCT01163656|P2|Participant Flow|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
874811|NCT01163656|P1|Participant Flow|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
874812|NCT01163656|O2|Outcome|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
874813|NCT01163656|O1|Outcome|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
874814|NCT01163656|E2|Reported Event|Glidescope Videoscope Approach|Subjects were randomly assigned to an arm.
874815|NCT01163656|E1|Reported Event|Direct Laryngoscopy Approach|Subjects were randomly assigned to an arm.
874816|NCT01163617|B1|Baseline|All Study Participants|Includes participants from Phases A and B of the study
874817|NCT01163617|P8|Participant Flow|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
874818|NCT01163617|P7|Participant Flow|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
874819|NCT01163617|P6|Participant Flow|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
874820|NCT01163617|P5|Participant Flow|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
874821|NCT01163617|P4|Participant Flow|Physiolis Autoinjector First, Then Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2) (Phase A)
874822|NCT01163617|P3|Participant Flow|Current Autoinjector First, Then Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2) (Phase A)
874823|NCT01163617|P2|Participant Flow|Physiolis Syringe First, Then Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2) (Phase A)
874824|NCT01163617|P1|Participant Flow|Current Syringe First, Then Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2) (Phase A)
874825|NCT01163617|O2|Outcome|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C)
892138|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
874828|NCT01163617|O1|Outcome|Current Autoinjector|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) and room temperature (20° to 27°C)
874829|NCT01163617|O2|Outcome|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C)
874830|NCT01163617|O1|Outcome|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C)
874831|NCT01163617|O4|Outcome|Physiolis/Current Autoinjector|Self-injection using Physiolis autoinjector at Week 0 (Visit 1), self-injection using current autoinjector at Week 2 (Visit 2)
874832|NCT01163617|O3|Outcome|Current/Physiolis Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1), self-injection using Physiolis autoinjector at Week 2 (Visit 2)
874833|NCT01163617|O2|Outcome|Physiolis/Current Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1), self-injection using current syringe at Week 2 (Visit 2)
874834|NCT01163617|O1|Outcome|Current/Physiolis Syringe|Self-injection using current syringe at Week 0 (Visit 1), self-injection using Physiolis syringe at Week 2 (Visit 2)
874835|NCT01163617|E8|Reported Event|Current Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at room temperature (20° to 27°C) (Phase B)
874836|NCT01163617|E7|Reported Event|Physiolis Autoinjector 20° to 27°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at room temperature (20° to 27°C) (Phase B)
874837|NCT01163617|E6|Reported Event|Current Autoinjector 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using current autoinjector at storage temperature (2° to 8°C) (Phase B)
874838|NCT01163617|E5|Reported Event|Physiolis Autoinjector at 2° to 8°C|Injection performed by health care provider at Week 4 (Visit 3) using Physiolis autoinjector at storage temperature (2° to 8°C) (Phase B)
874839|NCT01163617|E4|Reported Event|Physiolis Autoinjector|Self-injection using Physiolis autoinjector at Week 0 or Week 2 (Visit 2) (Phase A)
874840|NCT01163617|E3|Reported Event|Current Autoinjector|Self-injection using current autoinjector at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
874841|NCT01163617|E2|Reported Event|Physiolis Syringe|Self-injection using Physiolis syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
874842|NCT01163617|E1|Reported Event|Current Syringe|Self-injection using current syringe at Week 0 (Visit 1) or Week 2 (Visit 2) (Phase A)
874843|NCT01163604|B3|Baseline|Total|Total of all reporting groups
874844|NCT01163604|B2|Baseline|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
874845|NCT01163604|B1|Baseline|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
874846|NCT01163604|P2|Participant Flow|"Aspirin and Clopidogrel Interventions Group"|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
874847|NCT01163604|P1|Participant Flow|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
874848|NCT01163604|O2|Outcome|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
874849|NCT01163604|O1|Outcome|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
874850|NCT01163604|E2|Reported Event|Non-argatroban Treated Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.~non-argatroban treated group: Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment."
874851|NCT01163604|E1|Reported Event|Argatroban Group|"Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive continuous infusions of argatroban for 2 days before and 3 days after stenting, with accompanied aspirin and clopidogrel treatment.~Argatroban: Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment"
874852|NCT01163474|B1|Baseline|Arm 1 - Evaluate Video Clinic Visit|Evaluate video clinic visit prior to Face-to-Face usual care visit
874853|NCT01163474|P1|Participant Flow|Arm 1 - Evaluate Video Clinic Visit Prior to Face-to-Face Usua|Evaluate video clinic visit prior to Face-to-Face usual care visit
874854|NCT01163474|O1|Outcome|Arm 1 - Provider Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
874855|NCT01163474|O1|Outcome|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
874856|NCT01163474|E2|Reported Event|Arm 2|Face-to-face follow up for subjects (control)
874857|NCT01163474|E1|Reported Event|Arm 1 - Evaluate Video Conferencing|"Evaluate virtual video conference follow-up clinic visit~Evaluative process: Evaluative process using video conferencing"
877283|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
874858|NCT01163461|B1|Baseline|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
874859|NCT01163461|P2|Participant Flow|Immediate Aphasia Therapy|14 individuals were randomized to received 60 hours of aphasia therapy immediately following testing. (no delay)
874860|NCT01163461|P1|Participant Flow|Delayed Aphasia Therapy|14 individuals were randomized to received aphasia therapy following a 6-week control delay phase. Upon completion of the 6-week control phase, they received 60 hours of behavioral therapy
874861|NCT01163461|O1|Outcome|Behavioral Aphasia Therapy|Single group, open trail where 28 individuals with aphasia received 60 hours of therapy
874862|NCT01163461|E1|Reported Event|Single Group Open Trial|28 individuals were randomized to receive either immediate speech therapy, or delayed speech therapy (following a 6 week delay period to control for Hawthorne effects). All participants received 60 hours of speech therapy 2 hours/day, 5 days/week for 6 weeks. Language behaviors were testing before, after and 3 months later.
874863|NCT01163318|B1|Baseline|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
874864|NCT01163318|P1|Participant Flow|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
874865|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
874866|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
874867|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
874868|NCT01163318|O1|Outcome|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
874869|NCT01163318|E1|Reported Event|Adalimumab 40 mg/0.8 mL Syringe for Subcutaneous Injection|Participants with rheumatoid arthritis who received adalimumab, per approved label
874870|NCT01163292|B3|Baseline|Total|Total of all reporting groups
874871|NCT01163292|B2|Baseline|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874872|NCT01163292|B1|Baseline|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874873|NCT01163292|P2|Participant Flow|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874874|NCT01163292|P1|Participant Flow|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874875|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874876|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874877|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874878|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874879|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874880|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874881|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874882|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874883|NCT01163292|O2|Outcome|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874884|NCT01163292|O1|Outcome|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874885|NCT01163292|E2|Reported Event|Non-Adalimumab|Participants who discontinued adalimumab treatment after completion of Study NCT00870467 (M06-859)
874886|NCT01163292|E1|Reported Event|Adalimumab|Participants who continued adalimumab treatment after completion of Study NCT00870467(M06-859)
874887|NCT01163279|B3|Baseline|Total|Total of all reporting groups
874888|NCT01163279|B2|Baseline|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
874889|NCT01163279|B1|Baseline|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874890|NCT01163279|P2|Participant Flow|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874951|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874986|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874891|NCT01163279|P1|Participant Flow|Cogntive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874892|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874893|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874894|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874895|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874896|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874897|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874898|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874899|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874900|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874901|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874902|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874981|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
892139|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
874903|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874904|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874905|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874906|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874907|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874908|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874909|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874910|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator was an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants received factual information on brain structure and function, age-related cognitive changes, and general brain health issues and spent time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework consisted of reading assignments related to the session topics.
874911|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874912|NCT01163279|O2|Outcome|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
874913|NCT01163279|O1|Outcome|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874914|NCT01163279|E2|Reported Event|Psychosocial Education|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
892140|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
874915|NCT01163279|E1|Reported Event|Cognitive Training|Real world strategy approach: The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
874916|NCT01163266|B4|Baseline|Total|Total of all reporting groups
874917|NCT01163266|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874918|NCT01163266|B2|Baseline|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874919|NCT01163266|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874920|NCT01163266|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874921|NCT01163266|P2|Participant Flow|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874922|NCT01163266|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874923|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874924|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874925|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874926|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874927|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874928|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874929|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874930|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874931|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874932|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874933|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874934|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874935|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874936|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874937|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874938|NCT01163266|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874939|NCT01163266|O2|Outcome|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874940|NCT01163266|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874941|NCT01163266|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week then vortioxetine 20 mg, encapsulated tablets, orally, once daily for up to 7 weeks.
874942|NCT01163266|E2|Reported Event|Vortioxetine 10 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for up to 8 weeks.
874943|NCT01163266|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 8 weeks.
874944|NCT01163214|B3|Baseline|Total|Total of all reporting groups
874945|NCT01163214|B2|Baseline|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874946|NCT01163214|B1|Baseline|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874947|NCT01163214|P2|Participant Flow|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874948|NCT01163214|P1|Participant Flow|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874949|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874950|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
892141|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
874952|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874953|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874954|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874955|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874956|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874957|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874958|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874959|NCT01163214|O2|Outcome|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874960|NCT01163214|O1|Outcome|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874961|NCT01163214|E2|Reported Event|Periarticular Injection|"Injection combination prior to skin closure.~Periarticular Injection: Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories."
874962|NCT01163214|E1|Reported Event|Nerve Block|"Preoperative femoral block with indwelling femoral catheter and a single shot sciatic block.~Nerve Block: Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine."
874963|NCT01163162|B1|Baseline|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
874964|NCT01163162|P1|Participant Flow|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
874965|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
874966|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
874967|NCT01163162|O1|Outcome|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
874968|NCT01163162|E1|Reported Event|Paricalcitol|After baseline measurements are complete, pt will receive 2 mcg Paricalcitol (Zemplar) for 7 consecutive days. After this, Kidney function will again be measured. The pt will then be washed off the paricalcitol for 7 days then kidney function will be measured for the last time.
874969|NCT01163097|B4|Baseline|Total|Total of all reporting groups
874970|NCT01163097|B3|Baseline|Untreated Control|Treatment C: control group without any treatment administered
874971|NCT01163097|B2|Baseline|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874972|NCT01163097|B1|Baseline|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
874973|NCT01163097|P3|Participant Flow|Untreated Control|Treatment C: control group without any treatment administered
874974|NCT01163097|P2|Participant Flow|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874975|NCT01163097|P1|Participant Flow|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
874976|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874977|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874978|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874979|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874980|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874987|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874988|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874989|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874990|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874991|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874992|NCT01163097|O3|Outcome|Untreated Control|Treatment C: control group without any treatment administered
874993|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874994|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
874995|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874996|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
874997|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
874998|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
874999|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875000|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875001|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875002|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875003|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875004|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875005|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875006|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875007|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875008|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875009|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875010|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875011|NCT01163097|O2|Outcome|Untreated Control|Treatment C: control group without any treatment administered
875012|NCT01163097|O1|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875013|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875014|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875015|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875016|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875017|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875018|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875019|NCT01163097|O2|Outcome|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875020|NCT01163097|O1|Outcome|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875021|NCT01163097|E3|Reported Event|Untreated Control|Treatment C: control group without any treatment administered
875022|NCT01163097|E2|Reported Event|Palifermin Alone|Treatment B: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections
875023|NCT01163097|E1|Reported Event|Palifermin - Heparin|Treatment A: palifermin 40 µg/kg/day for three consecutive days as IV bolus injections and continuous heparin IV infusion
875024|NCT01163032|B4|Baseline|Total|Total of all reporting groups
875025|NCT01163032|B3|Baseline|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875026|NCT01163032|B2|Baseline|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875027|NCT01163032|B1|Baseline|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875028|NCT01163032|P3|Participant Flow|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875029|NCT01163032|P2|Participant Flow|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875030|NCT01163032|P1|Participant Flow|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875031|NCT01163032|O1|Outcome|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875032|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875033|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875034|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875035|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875036|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875037|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875038|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875039|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875040|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875041|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875042|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875043|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875044|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875045|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875046|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875047|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875048|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875049|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875050|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875051|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875052|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875053|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875054|NCT01163032|O2|Outcome|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875055|NCT01163032|O1|Outcome|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875056|NCT01163032|E3|Reported Event|Open Label Tasimelteon|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875057|NCT01163032|E2|Reported Event|Placebo (Randomized)|"Placebo capsules, PO daily for 6 months~Placebo: Placebo capsules, PO daily for 6 months"
875058|NCT01163032|E1|Reported Event|Tasimelteon (Randomized)|"20 mg tasimelteon capsules, PO daily for 6 months~tasimelteon: 20 mg tasimelteon capsules, PO daily for 6 months"
875059|NCT01162863|B4|Baseline|Total|Total of all reporting groups
875060|NCT01162863|B3|Baseline|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875061|NCT01162863|B2|Baseline|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875062|NCT01162863|B1|Baseline|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875063|NCT01162863|P3|Participant Flow|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875064|NCT01162863|P2|Participant Flow|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875065|NCT01162863|P1|Participant Flow|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875066|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875125|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875067|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875068|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875069|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875070|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875071|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875072|NCT01162863|O3|Outcome|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875073|NCT01162863|O2|Outcome|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875074|NCT01162863|O1|Outcome|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875075|NCT01162863|E3|Reported Event|Lubiprostone 8 mcg BID|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875076|NCT01162863|E2|Reported Event|Lubiprostone 24 mcg QD|"Lubiprostone: lubiprostone taken either at a dose of 8 mcg orally twice daily for 28 days or 24 mcg orally once daily for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875077|NCT01162863|E1|Reported Event|Placebo|"Placebo: taken orally for 28 days~Smartpill wireless motility capsule: Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus"
875078|NCT01162733|B3|Baseline|Total|Total of all reporting groups
875079|NCT01162733|B2|Baseline|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
875080|NCT01162733|B1|Baseline|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
875081|NCT01162733|P2|Participant Flow|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
875082|NCT01162733|P1|Participant Flow|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
875083|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
875084|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
875085|NCT01162733|O2|Outcome|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
875086|NCT01162733|O1|Outcome|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
875087|NCT01162733|E2|Reported Event|Study Drug 2|"Vancomycin 30mg/kg~Vancomycin : 30mg/kg"
875088|NCT01162733|E1|Reported Event|Study Drug 1|"Vancomycin 15mg/kg~Vancomycin : 15mg/kg"
875089|NCT01162499|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
875090|NCT01162499|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The next day, all procedures were repeated except subjects received an IV infusion of Exendin-(9-39) which was started 1 hour prior to the meal challenge and continued for 4 hours. The dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects.
875091|NCT01162499|P1|Participant Flow|Exendin-(9-39) First, Then Vehicle|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose for the first 3 subjects was 300pmol/kg/min and, as planned, it was increased to 500pmol/kg/min for subsequent subjects. The next day, all procedures were repeated except subjects received an IV infusion of normal saline (vehicle) over 4 hours.
875126|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
877284|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
875092|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
875093|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
875094|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
875095|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
875096|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
875097|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
875098|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
875099|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
875100|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
875101|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
875102|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
875103|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
875127|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875251|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875104|NCT01162499|O3|Outcome|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
875105|NCT01162499|O2|Outcome|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
875106|NCT01162499|O1|Outcome|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
875107|NCT01162499|E3|Reported Event|Vehicle|After an overnight fast, an intravenous (IV) infusion of normal saline (vehicle) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The vehicle was infused over 4 total hours.
875108|NCT01162499|E2|Reported Event|Exendin-(9-39) 500pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 500pmol/kg/min, infused over 4 total hours.
875109|NCT01162499|E1|Reported Event|Exendin-(9-39) 300pmol/kg/Min Dose|After an overnight fast, an intravenous (IV) infusion of Exendin-(9-39) was started 1 hour prior to the meal challenge and continued for 4 hours. After the first hour of the infusion, subjects underwent a mixed meal tolerance test in which Pediasure (10cc/kg) was consumed by mouth or gastrostomy/nasogastric tube over a period of 15 minutes. Blood samples were drawn during the infusion to measure blood glucose, plasma insulin, glucagon and plasma glucagon-like-peptide-1 (GLP-1). The Exendin-(9-39) dose was 300pmol/kg/min, infused over 4 total hours.
875110|NCT01162473|B3|Baseline|Total|Total of all reporting groups
875111|NCT01162473|B2|Baseline|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
875112|NCT01162473|B1|Baseline|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
875113|NCT01162473|P2|Participant Flow|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
875114|NCT01162473|P1|Participant Flow|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
875115|NCT01162473|O2|Outcome|Immediate Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 3 and continued thru Week 35. Total active participation lasted 38 weeks.
875116|NCT01162473|O1|Outcome|Delayed Sensitivity|All subjects underwent a food challenge (week 2). Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder began build-up of desensitization during Week 16 and continued thru Week 50. Total active participation lasted 51 weeks.
875117|NCT01162473|E2|Reported Event|Immediate Desensitization|Subjects undergoing immediate desensitization via milk oral immunotherapy with milk protein powder (29 week protocol)
875118|NCT01162473|E1|Reported Event|Delayed Desensitization|Subjects undergoing delayed desensitization via milk oral immunotherapy with milk protein powder (42 week protocol).
875119|NCT01162421|B3|Baseline|Total|Total of all reporting groups
875120|NCT01162421|B2|Baseline|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875121|NCT01162421|B1|Baseline|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875122|NCT01162421|P2|Participant Flow|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875123|NCT01162421|P1|Participant Flow|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875124|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875128|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875129|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875130|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875131|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875132|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875133|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875134|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875135|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875136|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875137|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875138|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875139|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875140|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875141|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875142|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875143|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875144|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875145|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875146|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875147|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875148|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875149|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875150|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875151|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875152|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875153|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875154|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875155|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875156|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875157|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875158|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875159|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875160|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875161|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875162|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875163|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875164|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875165|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875166|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875167|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875168|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875169|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875170|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875171|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875172|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875173|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875174|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875175|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875176|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875177|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875178|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875179|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875180|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875181|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875182|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875183|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875184|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875185|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875186|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875187|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875188|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875189|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875190|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875191|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875192|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875193|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875194|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875195|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875196|NCT01162421|O2|Outcome|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875197|NCT01162421|O1|Outcome|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875198|NCT01162421|E2|Reported Event|Early Adalimumab|Participants received 40 mg of adalimumab administered subcutaneously at Baseline and then every other week for 24 months. Participants received a methotrexate regimen based on local guidelines and their study doctor's judgment.
875199|NCT01162421|E1|Reported Event|Standard of Care|Participants received methotrexate and other disease modifying antirheumatic drugs as per local treatment guidelines and study doctor's judgement. Adalimumab may have been initiated after a minimum of 6 months.
875200|NCT01162317|B3|Baseline|Total|Total of all reporting groups
875201|NCT01162317|B2|Baseline|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
875202|NCT01162317|B1|Baseline|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
875203|NCT01162317|P2|Participant Flow|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
875216|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
875204|NCT01162317|P1|Participant Flow|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
875205|NCT01162317|O2|Outcome|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
875206|NCT01162317|O1|Outcome|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
875207|NCT01162317|O2|Outcome|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
875208|NCT01162317|O1|Outcome|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
875209|NCT01162317|E2|Reported Event|Arm 2: Acupuncture|"acupuncture~Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes."
875210|NCT01162317|E1|Reported Event|Arm 1: Sham Acupuncture|"sham acupuncture~Sham Acupuncture: Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration."
875211|NCT01162304|B1|Baseline|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875212|NCT01162304|P1|Participant Flow|ER Oxycodone vs IR Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours~IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875213|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875214|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
875215|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875217|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875218|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
875219|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875220|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
875221|NCT01162304|O2|Outcome|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875222|NCT01162304|O1|Outcome|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
875223|NCT01162304|E2|Reported Event|Immediate Release Oxycodone|"IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every four hours~Immediate Release Oxycodone: IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours"
875224|NCT01162304|E1|Reported Event|Extended Release Oxycodone|"Extended release Oxycodone to assess pain relief adverse effects, treatment satisfaction and impact of treatment on health related quality of life.~Extended Release Oxycodone: 40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours"
875225|NCT01162135|B1|Baseline|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
875226|NCT01162135|P1|Participant Flow|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
875227|NCT01162135|O1|Outcome|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
875228|NCT01162135|E1|Reported Event|Digoxin|Patients receive digoxin PO daily. Treatment repeats every 28 days for up to 6-12 courses in the absence of disease progression or unacceptable toxicity
875229|NCT01162122|B3|Baseline|Total|Total of all reporting groups
875230|NCT01162122|B2|Baseline|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875231|NCT01162122|B1|Baseline|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875232|NCT01162122|P2|Participant Flow|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875233|NCT01162122|P1|Participant Flow|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875234|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875235|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875236|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875237|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875238|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875239|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875240|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875241|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875242|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875243|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875244|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875245|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875246|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875247|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875248|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875249|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875250|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
877285|NCT01155323|E2|Reported Event|Omafilcon A|soft contact lens replaced daily, worn for one week.
875252|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875253|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875254|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875255|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875256|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875257|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875258|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875259|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875260|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875261|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875262|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875263|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875264|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875265|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875266|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875267|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875268|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875269|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875270|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875271|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875272|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875273|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875274|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875275|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875276|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875277|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875278|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875279|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875280|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875281|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875282|NCT01162122|O2|Outcome|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875283|NCT01162122|O1|Outcome|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875284|NCT01162122|O3|Outcome|aTIV_Lot 3|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 3
875285|NCT01162122|O2|Outcome|aTIV_Lot 2|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 2
875286|NCT01162122|O1|Outcome|aTIV_Lot 1|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from Lot 1
875287|NCT01162122|E2|Reported Event|Licensed TIV|Subjects received one dose of non-adjuvanted trivalent subunit influenza vaccine (TIV).
875288|NCT01162122|E1|Reported Event|aTIV (Pooled)|Subjects received one dose of MF59-adjuvanted trivalent subunit influenza vaccine (aTIV) from one of three consecutive lots (Lot 1, Lot 2 or Lot 3).
875289|NCT01162096|B1|Baseline|Transplantation|
875290|NCT01162096|P1|Participant Flow|Transplantation|
875291|NCT01162096|O1|Outcome|Transplantation|
875292|NCT01162096|E1|Reported Event|Transplantation|
875293|NCT01161771|B1|Baseline|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875294|NCT01161771|P1|Participant Flow|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875295|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875296|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875297|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875298|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875299|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875300|NCT01161771|O1|Outcome|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875301|NCT01161771|E1|Reported Event|Patients With Cataract and Corneal Astigmatism|Patients with cataract(s) and corneal astigmatism who received surgical treatment (cataract extraction and limbal-relaxing incisions)
875302|NCT01161628|B1|Baseline|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875303|NCT01161628|P1|Participant Flow|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875304|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875305|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875306|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875307|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875308|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875309|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875310|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875311|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875312|NCT01161628|O1|Outcome|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875313|NCT01161628|E1|Reported Event|Rituxan|"all patients will receive Rituxan for the treatment of newly diagnosed chronic GVHD~Rituximab: Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months."
875314|NCT01161563|B3|Baseline|Total|Total of all reporting groups
875315|NCT01161563|B2|Baseline|Triptorelin First, Then Leuprolide Acetate|Triptorelin pamoate suspension (Trelstar 22.5 mg) injected intramuscularly in the buttock 6 months before injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) subcutaneously in upper or mid-abdominal area.
875316|NCT01161563|B1|Baseline|Leuprolide Acetate First, Then Triptorelin|Polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) injected subcutaneously in upper or mid-abdominal area 6 months before injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.
875317|NCT01161563|P2|Participant Flow|Leuprolide Acetate First, Then Triptorelin|"Injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area, followed 6 months later by injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock.~A detailed breakdown of participant flow by treatment period for each arm is not available."
875318|NCT01161563|P1|Participant Flow|Triptorelin First, Then Leuprolide Acetate|"Injection of triptorelin pamoate suspension (Trelstar 22.5 mg) intramuscularly in the buttock, followed 6 months later by injection of polymeric matrix formulation of leuprolide acetate (Eligard 45 mg) in the upper or mid-abdominal area.~A detailed breakdown of participant flow by treatment period for each arm is not available."
875319|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
875320|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
875321|NCT01161563|O2|Outcome|Triptorelin Pamoate|Results combined for the triptorelin pamoate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
875322|NCT01161563|O1|Outcome|Leuprolide Acetate|Results combined for the leuprolide acetate treatment period for both randomization groups for the Per-protocol population (n=107), defined as all patients who receive both study drugs and complete both post-injection questionnaires.
875323|NCT01161563|E2|Reported Event|Triptorelin Pamoate|
875324|NCT01161563|E1|Reported Event|Leuprolide Acetate|
875361|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
892142|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
875325|NCT01161537|B1|Baseline|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875326|NCT01161537|P1|Participant Flow|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 milligram (mg) orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875327|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875328|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875329|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875330|NCT01161537|O1|Outcome|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
875331|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875332|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875333|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875334|NCT01161537|O2|Outcome|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
875335|NCT01161537|O1|Outcome|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
875336|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875337|NCT01161537|O1|Outcome|VX-770|"Part A: Subjects received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period), followed by VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), and then placebo tablets matched to VX-770 150 mg orally twice daily from Day 43 to 57 (Placebo washout period) during Part A of the study.~Part B: Subjects received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study. Part B included subjects from Part A and newly enrolled subjects."
875338|NCT01161537|E3|Reported Event|Part B VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily for 48 weeks during Part B of the study were assessed between Day 1 to Week 48 of Part B. Part B included subjects from Part A and newly enrolled subjects.
875339|NCT01161537|E2|Reported Event|Part A VX-770 Treatment|Subjects who received VX-770 150 mg tablets orally twice daily from Day 15 to 42 (VX-770 treatment period), during Part A of the study were assessed between Day 15 to 42 of Part A.
875340|NCT01161537|E1|Reported Event|Part A Placebo Run in/Washout|Subjects who received placebo tablets matched to VX-770 150 mg orally twice daily from Day 1 to 14 (Placebo run-in period) and from Day 43 to 57 (Placebo washout period) during Part A of the study were assessed between Day 1 to 14 and Day 43 to 57 of Part A.
875341|NCT01161498|B3|Baseline|Total|Total of all reporting groups
875342|NCT01161498|B2|Baseline|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875343|NCT01161498|B1|Baseline|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875344|NCT01161498|P2|Participant Flow|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ plaque-forming units (PFU)/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875345|NCT01161498|P1|Participant Flow|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875346|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875347|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875348|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875349|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875350|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875351|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875352|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875353|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875354|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875355|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875356|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875357|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875358|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875359|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875360|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875362|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875363|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875364|NCT01161498|O2|Outcome|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875365|NCT01161498|O1|Outcome|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875366|NCT01161498|E2|Reported Event|Talimogene Laherparepvec + Radiation/Cisplatin|The first dose of talimogene laherparepvec was up to 8 mL total volume (up to 4 mL per lesion) at 10⁶ PFU/mL, administered into all injectable affected nodes on Day 0. Subsequent doses were up to 8 mL total volume (up to 4 mL per lesion) at 10⁸ PFU/mL on Days 21, 42, and 63. Participants also received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42 and radiation administered concurrently in 35 fractions over a 7-week period.
875367|NCT01161498|E1|Reported Event|Radiation/Cisplatin|Participants received cisplatin (100 mg/m²) administered intravenously on Days 0, 21, and 42. Radiation was administered concurrently with cisplatin in 35 fractions over a 7-week period.
875368|NCT01161472|B1|Baseline|Entire Study Population|All participants randomized to any treatment (fesoterodine 4 mg tablet first, fesoterodine 8 mg tablet first, alprazolam 1 mg capsule first and placebo first).
875369|NCT01161472|P4|Participant Flow|Placebo, Aplrazolam 1 mg, Fesoterodine 4 mg, Fesoterodine 8 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
875370|NCT01161472|P3|Participant Flow|Aplrazolam 1 mg, Fesoterodine 8 mg, Placebo, Fesoterodine 4 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
875371|NCT01161472|P2|Participant Flow|Fesoterodine 8 mg, Fesoterodine 4 mg, Aplrazolam 1 mg, Placebo|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; then fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
875372|NCT01161472|P1|Participant Flow|Fesoterodine 4 mg, Placebo, Fesoterodine 8 mg, Aplrazolam 1 mg|Fesoterodine 4 milligram (mg) tablet administered orally once daily (OD) for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the first intervention period; followed by placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the second intervention period; then fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in the third intervention period; and placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in the fourth intervention period. A washout period of at least 3 to 6 days was maintained between each treatment period.
875373|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875374|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875375|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875376|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875377|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875378|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875379|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875380|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875381|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875382|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875383|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875384|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875385|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875386|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875387|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875388|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875389|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875390|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875391|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875392|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875393|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875394|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875395|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875396|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875397|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875398|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875399|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875400|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875401|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875402|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875403|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875404|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875472|NCT01161329|O2|Outcome|Intervention Group|High Intensity Functional Exercise Program
875473|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
875405|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875406|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875407|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875408|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875409|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875410|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875411|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875412|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875413|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875414|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875415|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875416|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875417|NCT01161472|O4|Outcome|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875418|NCT01161472|O3|Outcome|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875419|NCT01161472|O2|Outcome|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875420|NCT01161472|O1|Outcome|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875421|NCT01161472|E4|Reported Event|Placebo|Placebo matched to fesoterodine 4 mg or 8 mg tablet orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875422|NCT01161472|E3|Reported Event|Aplrazolam 1 mg|Placebo matched to fesoterodine 4 mg or 8 mg tablet administered orally OD for 6 days along with a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875423|NCT01161472|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 4 mg tablet administered orally OD for the first 3 days followed by fesoterodine 8 mg tablet orally OD for the next 3 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875424|NCT01161472|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet administered orally OD for 6 days along with placebo matched to a single oral dose of alprazolam 1 mg capsule on Day 6 in any of the intervention periods.
875425|NCT01161446|B3|Baseline|Total|Total of all reporting groups
875426|NCT01161446|B2|Baseline|Standard Testing|HIV testing as usual.
875427|NCT01161446|B1|Baseline|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
875428|NCT01161446|P2|Participant Flow|Standard Testing|HIV testing as usual.
875429|NCT01161446|P1|Participant Flow|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
875430|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
875431|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
875432|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
875433|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
875434|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
875435|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
875436|NCT01161446|O2|Outcome|Standard Testing|HIV testing as usual.
875437|NCT01161446|O1|Outcome|Home Testing|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
875438|NCT01161446|E2|Reported Event|Standard Testing|HIV testing as usual.
875439|NCT01161446|E1|Reported Event|Home Testing|"Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.~Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test: The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV."
875440|NCT01161420|B1|Baseline|Inspire Therapy|"Study subjects continue to use Inspire therapy~Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration."
875441|NCT01161420|P1|Participant Flow|Inspire Therapy|126 subjects were implanted with Inspire therapy
875442|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects were implanted with Inspire therapy; 124 subjects completed this visit (two expired prior to the 12-month visit).
875443|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
875444|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects completed the baseline questionnaire, however 123 study subjects completed the 12-month questionnaire; two subjects did not completed this questionnaire and one subject expired.
875445|NCT01161420|O1|Outcome|Inspire Therapy|126 subjects implanted with Inspire therapy
875446|NCT01161420|O2|Outcome|Withdrawal|Twenty-three (23) patients were in the therapy withdrawal (OFF) group.
875447|NCT01161420|O1|Outcome|Maintenance|Twenty-three (23) patients were in the therapy maintenance (ON) group
875448|NCT01161420|O1|Outcome|All Subjects|126 implanted study subjects
875449|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
875450|NCT01161420|O1|Outcome|Inspire Therapy|Study subjects continue to use Inspire therapy; Inspire Upper Airway Stimulator: The stimulator is surgically positioned subcutaneously near the clavicle in the upper chest, and connects to a stimulation lead (around a hypoglossal nerve) and a sensing lead (in the chest). The stimulation contracts a patient's upper airway muscles to maintain airway patency, with the intent to keep the airway open during inspiration.
875451|NCT01161420|E1|Reported Event|Inspire Therapy|This pivotal trial was to evaluate safety via a description of all reported adverse events. Per the IDE-approved protocol, no formal statistical hypothesis was tested as part of the safety assessment.
875452|NCT01161407|B3|Baseline|Total|Total of all reporting groups
875453|NCT01161407|B2|Baseline|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
875454|NCT01161407|B1|Baseline|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
875455|NCT01161407|P2|Participant Flow|Placebo Then Calcium|"Crossover order was placebo then calcium, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
875456|NCT01161407|P1|Participant Flow|Calcium Then Placebo|"Crossover order was calcium then placebo, separated by at least a 3 week washout period.~Calcium treatment was 1500 mg/d calcium as calcium carbonate given as three 500 mg calcium capsules at each of the three meals per day. Placebo was identical in shape, appearance, and administration."
875457|NCT01161407|O2|Outcome|Calcium|
875458|NCT01161407|O1|Outcome|Placebo|
875459|NCT01161407|O2|Outcome|Calcium|
875460|NCT01161407|O1|Outcome|Placebo|
875461|NCT01161407|O2|Outcome|Calcium|
875462|NCT01161407|O1|Outcome|Placebo|
875463|NCT01161407|E2|Reported Event|Calcium|
875464|NCT01161407|E1|Reported Event|Placebo|
875465|NCT01161329|B3|Baseline|Total|Total of all reporting groups
875466|NCT01161329|B2|Baseline|Intervention Group|High Intensity Functional Exercise Program
875467|NCT01161329|B1|Baseline|Controlgroup|Ordinary life.
875468|NCT01161329|P2|Participant Flow|Intervention Group|High-Intensity Functional Exercise Program (HIFE) in combination with motivational group discussions two times a week. .
875469|NCT01161329|P1|Participant Flow|Controlgroup|Instructed to live their ordinary life.
875470|NCT01161329|O2|Outcome|Group Exercise Program|High-Intensity Functional Exercise Program
875471|NCT01161329|O1|Outcome|Controlgroup|Ordinary life.
875477|NCT01161225|B3|Baseline|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875478|NCT01161225|B2|Baseline|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875479|NCT01161225|B1|Baseline|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875480|NCT01161225|P3|Participant Flow|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875481|NCT01161225|P2|Participant Flow|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875482|NCT01161225|P1|Participant Flow|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875483|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875484|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875485|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875486|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders
875487|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program
875488|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program.
875489|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875490|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875491|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875545|NCT01160822|B7|Baseline|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875797|NCT01160380|P1|Participant Flow|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875492|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875493|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875494|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875495|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875496|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875497|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875498|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875499|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875500|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875501|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875502|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875503|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months
875504|NCT01161225|O3|Outcome|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875747|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
875505|NCT01161225|O2|Outcome|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875506|NCT01161225|O1|Outcome|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875507|NCT01161225|E3|Reported Event|Peer Leader Group|Teens who participated in the study as peer leaders. This group attended 3-day intense training program (a total of 12 hours) offered by a nurse practitioner. The training program covered not only asthma-related content but also leadership training. Then, each peer leader pair facilitated the peer-led asthma self-management program for a small group of 6-8 teens in the camp and made monthly contacts for 9 months. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875508|NCT01161225|E2|Reported Event|Control Group|This is the group who participated in an adult-led asthma self-management program. This group attended an asthma self-management program offered by healthcare professionals (physician and nurse practitioner) in a camp setting. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875509|NCT01161225|E1|Reported Event|Intervention Group|This is the group who participated in a peer-led asthma self-management program. This group attended an asthma self-management program led by peer leaders in a camp setting. Afterward, the group received monthly phone contacts from their peer leaders who offered continuous support, encouragement and reminder throughout the 9-month study period. Follow-up assessments (including quality of life, asthma control, healthcare utilization, asthma knowledge, self-efficacy and attitude toward asthma) were completed every 3 months for 9 months.
875510|NCT01161173|B1|Baseline|Cohort|Participants in the observational cohort received second-line therapy with Tarceva. At the time of discontinuation of Tarceva, a third-line chemotherapy or best supportive care were initiated as appropriate.
875511|NCT01161173|P1|Participant Flow|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
875512|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
875513|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
875514|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
875515|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
875516|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
875517|NCT01161173|O1|Outcome|Erlotinib|Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.
875518|NCT01161173|E1|Reported Event|Erlotinib|"Participants received erlotinib (Tarceva) at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics. The recommended daily dose of erlotinib is 150 mg orally once daily.~Erlotinib: Erlotinib was provided in the retail versions of the product."
875519|NCT01160848|B3|Baseline|Total|Total of all reporting groups
875520|NCT01160848|B2|Baseline|3 Areas Per Patient, 24 Hours|
875521|NCT01160848|B1|Baseline|3 Areas Per Patient, 3 Hours|
875522|NCT01160848|P2|Participant Flow|3 Areas Per Patient, 24 Hours|Group 1: Visonac left on skin for 1 hour Group 2: Visonac left on skin for 24 hours, area 1 Group 3: Visonac left on skin for 24 hours, area 2
875523|NCT01160848|P1|Participant Flow|3 Areas Per Patient, 3 Hours|Visonac : MAL 80 mg/g Group 1: Alcohol wipe and Visonac without occlusion Group 2: Saline wipe and Visonac with occlusion Group 3: Saline wipe and Visonac without occlusion
875524|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
875525|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
875526|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
875527|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
875528|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
875529|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
875530|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
875531|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
875532|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
875533|NCT01160848|O3|Outcome|Visonac Left on Skin for 24 Hours in Area 2|
875534|NCT01160848|O2|Outcome|Visonac Left on Skin for 24 Hours in Area 1|
875535|NCT01160848|O1|Outcome|Visonac Wiped Off After 1 Hour|
875536|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
875537|NCT01160848|O2|Outcome|Area Cleaned With Saline|
875538|NCT01160848|O1|Outcome|Part 1: Area Cleaned With Saline and Occluded With Tegaderm|
875539|NCT01160848|O3|Outcome|Area Cleaned With Ethyl Alcohol Solution|
875540|NCT01160848|O2|Outcome|Area Cleaned With Saline|
875546|NCT01160822|B6|Baseline|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875547|NCT01160822|B5|Baseline|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875548|NCT01160822|B4|Baseline|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
875549|NCT01160822|B3|Baseline|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875550|NCT01160822|B2|Baseline|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875551|NCT01160822|B1|Baseline|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875552|NCT01160822|P7|Participant Flow|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875553|NCT01160822|P6|Participant Flow|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875554|NCT01160822|P5|Participant Flow|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875555|NCT01160822|P4|Participant Flow|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
875556|NCT01160822|P3|Participant Flow|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875557|NCT01160822|P2|Participant Flow|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875558|NCT01160822|P1|Participant Flow|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875559|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875560|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875561|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875562|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875563|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875564|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875565|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875566|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875567|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875568|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875569|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875570|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875571|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875572|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875573|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875574|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875575|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875576|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875577|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875578|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875579|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875580|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875581|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875582|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875583|NCT01160822|O4|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875584|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875585|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875586|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875587|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875748|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
875588|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875589|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875590|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875591|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875592|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875593|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875594|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875595|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875596|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875597|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875598|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875599|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875600|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875601|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875602|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875603|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875604|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875605|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875606|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875607|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875608|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875609|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875610|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875611|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875612|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875613|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875614|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875615|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875616|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875617|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875618|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875619|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875620|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875749|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
875621|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875622|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875623|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875624|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875625|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875626|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875627|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875628|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875629|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875630|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875631|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875632|NCT01160822|O3|Outcome|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875633|NCT01160822|O2|Outcome|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875634|NCT01160822|O1|Outcome|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875635|NCT01160822|O4|Outcome|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
875636|NCT01160822|O3|Outcome|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875637|NCT01160822|O2|Outcome|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875638|NCT01160822|O1|Outcome|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875639|NCT01160822|E7|Reported Event|Part B: Naproxen|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen 500mg tablets orally twice daily for 12 weeks.
875640|NCT01160822|E6|Reported Event|Part B: Placebo|Participants received a single intra-articular injection of canakinumab matching placebo on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875641|NCT01160822|E5|Reported Event|Part B: Canakinumab|Participants received a single intra-articular injection of 600 mg canakinumab on Day 1 and naproxen matching placebo tablets orally twice daily for 12 weeks.
875642|NCT01160822|E4|Reported Event|Part A: Placebo|Participants received a single intra-articular injection of canakinumab-matching placebo.
875643|NCT01160822|E3|Reported Event|Part A: Canakinumab 600 mg|Participants received a single intra-articular injection of 600 mg canakinumab.
875644|NCT01160822|E2|Reported Event|Part A: Canakinumab 300 mg|Participants received a single intra-articular injection of 300 mg canakinumab.
875645|NCT01160822|E1|Reported Event|Part A: Canakinumab 150 mg|Participants received a single intra-articular injection of 150 mg canakinumab.
875646|NCT01160770|B1|Baseline|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875647|NCT01160770|P1|Participant Flow|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875648|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875649|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875650|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875651|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875652|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875653|NCT01160770|O1|Outcome|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875654|NCT01160770|E1|Reported Event|Clobazam|Start dose was 0.5 mg/kg with a maximum of 40 mg/day to be adjusted; administered as tablets twice daily
875655|NCT01160744|B5|Baseline|Total|Total of all reporting groups
875656|NCT01160744|B4|Baseline|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875657|NCT01160744|B3|Baseline|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875658|NCT01160744|B2|Baseline|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875659|NCT01160744|B1|Baseline|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875660|NCT01160744|P4|Participant Flow|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of each every 21-day cycle. Participants were treated for up to 89 weeks.
875661|NCT01160744|P3|Participant Flow|Gem + Carb or Cis (Squamous)|"Gemcitabine (Gem): 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb [Area Under the Concentration Time Curve 5 (AUC 5)]: Day 1 of every 21-day cycle.~Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
875662|NCT01160744|P2|Participant Flow|Ram + Pem + Carb or Cis (Non-Squamous)|Ramucirumab (Ram): 10 milligrams/kilogram (mg/kg) Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875663|NCT01160744|P1|Participant Flow|Pem + Carb or Cis (Non-Squamous)|"Pemetrexed (Pem): 500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle.~Carboplatin (Carb) [Area Under the Concentration Time Curve 6 (AUC 6)] : Day 1 of every 21-day cycle.~Cisplatin (Cis): 75 mg/m² intravenous (IV) on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks."
875664|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875665|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875666|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
875667|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875668|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875669|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875670|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cisplatin: 75 mg/m² IV on Day 1 of each 21-day cycle. Participants were treated for up to 89 weeks.
875671|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875672|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875673|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875674|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875675|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875676|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875677|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875678|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875679|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875680|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875681|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875682|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875683|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
877286|NCT01155323|E1|Reported Event|Etafilcon A|soft contact lens replaced daily, worn for one week.
875684|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875685|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875686|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875687|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875688|NCT01160744|O4|Outcome|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875689|NCT01160744|O3|Outcome|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875690|NCT01160744|O2|Outcome|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875691|NCT01160744|O1|Outcome|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875692|NCT01160744|E4|Reported Event|Ram + Gem + Carb or Cis (Squamous)|Ram: 10 mg/kg on Day 1 of each every 21-day cycle. Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875693|NCT01160744|E3|Reported Event|Gem + Carb or Cis (Squamous)|Gem: 1000 mg/m² on Days 1 and 8 of every 21-day cycle. Carb (AUC 5): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875694|NCT01160744|E2|Reported Event|Ram + Pem + Carb or Cis (Non-Squamous)|Ram: 10 mg/kg Day 1 of every 21-day cycle. Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875695|NCT01160744|E1|Reported Event|Pem + Carb or Cis (Non-Squamous)|Pem: 500 mg/m² on Day 1 of every 21-day cycle. Carb (AUC 6): Day 1 of every 21-day cycle. Cis: 75 mg/m² IV on Day 1 of every 21-day cycle. Participants were treated for up to 89 weeks.
875696|NCT01160640|B3|Baseline|Total|Total of all reporting groups
875697|NCT01160640|B2|Baseline|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
875698|NCT01160640|B1|Baseline|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
875699|NCT01160640|P2|Participant Flow|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
875700|NCT01160640|P1|Participant Flow|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
875701|NCT01160640|O2|Outcome|Histological Endometritis Absent|Women who did not have endometritis confirmed by histologic assessment for endometritis
875702|NCT01160640|O1|Outcome|Histological Endometritis Present|Women who had endometritis confirmed by histologic assessment for endometritis. Endometritis was defined as >1 plasma cell per 100X microscopic field, was assessed independently by 2 pathologists blinded to the design
875703|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
875704|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
875705|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
875706|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
875707|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
875708|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
875840|NCT01160237|E2|Reported Event|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875709|NCT01160640|O2|Outcome|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
875710|NCT01160640|O1|Outcome|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
875711|NCT01160640|E2|Reported Event|Ceftriaxone, Doxycycline, Metronidazole|"ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days~ceftriaxone, doxycycline, metronidazole: ceftriaxone 250 mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus metronidazole 500 mg PO bid x 14 days"
875712|NCT01160640|E1|Reported Event|Ceftriaxone, Doxycycline, Placebo|"ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days~ceftriaxone, doxycycline, placebo: ceftrixone 250mg IM single dose plus doxycycline 100 mg PO bid x 14 days plus placebo PO bid x 14 days"
875713|NCT01160614|B3|Baseline|Total|Total of all reporting groups
875714|NCT01160614|B2|Baseline|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875715|NCT01160614|B1|Baseline|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875716|NCT01160614|P2|Participant Flow|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875717|NCT01160614|P1|Participant Flow|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875718|NCT01160614|O2|Outcome|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875719|NCT01160614|O1|Outcome|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875720|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
875721|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
875722|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
875723|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
875724|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
875725|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
875726|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
875727|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
875728|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
875729|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
875730|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
875731|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
875732|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
875733|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 15 mg ORF
875734|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received single or multiple doses of 10 mg ORF
875735|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 20 mg ORF
875736|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 15 mg ORF
875737|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received single or multiple doses of 10 mg ORF
875738|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
875739|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
875740|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
875741|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
875742|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
875743|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
875744|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
875745|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
875746|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
875750|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
875751|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 15 mg ORF
875752|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years who received multiple doses of 10 mg ORF
875753|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years who received multiple doses of 20 mg ORF
875754|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years who received multiple doses of 15 mg ORF
875755|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years who received multiple doses of 10 mg ORF
875756|NCT01160614|O6|Outcome|≥ 12 to ≤ 16 Years (20 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 20 mg ORF. One patient took a single dose of ORF 30 mg and is included in this dose level.
875757|NCT01160614|O5|Outcome|≥ 12 to ≤ 16 Years (15 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 15 mg ORF
875758|NCT01160614|O4|Outcome|≥ 12 to ≤ 16 Years (10 mg ORF)|Children from ≥ 12 to ≤ 16 years received a single dose of 10 mg ORF
875759|NCT01160614|O3|Outcome|6 to < 12 Years (20 mg ORF)|Children from 6 to < 12 years received a single dose of 20 mg ORF
875760|NCT01160614|O2|Outcome|6 to < 12 Years (15 mg ORF)|Children from 6 to < 12 years received a single dose of 15 mg ORF
875761|NCT01160614|O1|Outcome|6 to < 12 Years (10 mg ORF)|Children from 6 to < 12 years received a single dose of 10 mg ORF
875762|NCT01160614|E2|Reported Event|≥ 12 to ≤ 16 Years|Children aged ≥ 12 to ≤ 16 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875763|NCT01160614|E1|Reported Event|6 to < 12 Years|Children aged 6 to < 12 Years received ORF Tablets (10 mg, 15 mg or 20 mg taken every 12 hours). Study treatment could have lasted from 12 hours (single dose) to 72 hours (5 doses).
875764|NCT01160484|B1|Baseline|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin + Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
875765|NCT01160484|P1|Participant Flow|DVD-R Single Arm|"Dose schematic of Dexamethasone + Bortezomib + Pegylated Liposomal Doxorubicin (PLD)+ Lenalidomide (DVD-R) Therapy:~Per 28 Day Cycle, patients will received drug in the following order, dosing and schedule:~1) Dexamethasone- 40 mg intravenous infusion (IV) on Days 1, 4, 8 and 11; 2) Bortezomib- 1.0 mg/m2 infused over 3 to 5 seconds followed by a standard saline flush on Days 1, 4, 8 and 11; 3) Pegylated Liposomal Doxorubicin- 4.0 mg/m2 IV as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle; and 4) Lenalidomide- 10 mg PO on days 1-14"
875766|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875767|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875768|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875769|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875770|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875841|NCT01160237|E1|Reported Event|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875771|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875772|NCT01160484|O1|Outcome|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875773|NCT01160484|E1|Reported Event|DVD-R Single Arm|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
875774|NCT01160458|B1|Baseline|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875775|NCT01160458|P1|Participant Flow|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875776|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875777|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875778|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875779|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875780|NCT01160458|O1|Outcome|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875781|NCT01160458|E1|Reported Event|IMC-A12 Monotherapy in Patients|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
875782|NCT01160445|B3|Baseline|Total|Total of all reporting groups
875783|NCT01160445|B2|Baseline|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875784|NCT01160445|B1|Baseline|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875785|NCT01160445|P2|Participant Flow|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875786|NCT01160445|P1|Participant Flow|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875787|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875788|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875789|NCT01160445|O2|Outcome|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875790|NCT01160445|O1|Outcome|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875791|NCT01160445|E2|Reported Event|HD IL-2 + Zanolimumab - Renal Cell|"Patients with metastatic renal cancer~Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875792|NCT01160445|E1|Reported Event|HD IL-2 + Zanolimumab - Melanoma|"Patients with metastatic melanoma Zanolimumab 14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.~Aldesleukin (IL-2) 720,000 IU/kg every 8 hours for a maximum of 15 doses."
875793|NCT01160380|B3|Baseline|Total|Total of all reporting groups
875794|NCT01160380|B2|Baseline|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.~Placebo: Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets."
875795|NCT01160380|B1|Baseline|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~armodafinil: Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets."
875796|NCT01160380|P2|Participant Flow|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875842|NCT01159938|B4|Baseline|Total|Total of all reporting groups
875798|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875799|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875800|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875801|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875802|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875803|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875804|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875805|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875806|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875807|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875808|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875809|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875810|NCT01160380|O2|Outcome|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily."
875811|NCT01160380|O1|Outcome|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily."
875812|NCT01160380|E2|Reported Event|Placebo-First|"These patients receive a placebo for the first 28 days of the study. They are then crossed over and receive armodafinil for the final 28 days of the study (days 29-56).~Placebo taken orally at 150 mg daily. Armodafinil taken orally at 150 mg daily.~AEs presented were those occurring during from Day 1 to Day 28 only"
875813|NCT01160380|E1|Reported Event|Armodafinil|"The patients receive armodafinil for all 56 days of the study.~Armodafinil taken orally at 150 mg daily. All patients receiving armodafinil, including patients that crossover, were evaluated for adverse events (AEs) and serious adverse events (SAEs)."
875814|NCT01160237|B4|Baseline|Total|Total of all reporting groups
875815|NCT01160237|B3|Baseline|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875816|NCT01160237|B2|Baseline|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875817|NCT01160237|B1|Baseline|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875818|NCT01160237|P3|Participant Flow|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875819|NCT01160237|P2|Participant Flow|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875820|NCT01160237|P1|Participant Flow|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875821|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875822|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875823|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875824|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875825|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875826|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875827|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875828|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875829|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875830|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875831|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875832|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875833|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875834|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875835|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875836|NCT01160237|O3|Outcome|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875837|NCT01160237|O2|Outcome|Fluarix Group|Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
875838|NCT01160237|O1|Outcome|Pandemrix Group|Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
875839|NCT01160237|E3|Reported Event|Control Group|Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
875843|NCT01159938|B3|Baseline|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
875844|NCT01159938|B2|Baseline|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
875845|NCT01159938|B1|Baseline|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875846|NCT01159938|P5|Participant Flow|T2DM With Normal UAER, Low to High|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875847|NCT01159938|P4|Participant Flow|T2DM With Normal UAER, High to Low|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875848|NCT01159938|P3|Participant Flow|T2DM With Albuminuria, Low to High|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875849|NCT01159938|P2|Participant Flow|T2DM With Albuminuria, High to Low|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period. The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875850|NCT01159938|P1|Participant Flow|Healthy Participants|Healthy participants with normal glucose tolerance and normal UAER did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875851|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875852|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875853|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875854|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875855|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875856|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875857|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875858|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875859|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875860|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams albumin per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875861|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose
875862|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875863|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875864|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875865|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875866|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875867|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875868|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875869|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875870|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875871|NCT01159938|O5|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875872|NCT01159938|O4|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875873|NCT01159938|O3|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875874|NCT01159938|O2|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875927|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875875|NCT01159938|O1|Outcome|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875876|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875877|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875878|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875879|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875880|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875881|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875882|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875883|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875884|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875885|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875886|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875887|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875888|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875889|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875890|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875891|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875956|NCT01159743|E1|Reported Event|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875892|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875893|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875894|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875895|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875896|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875897|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875898|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875899|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875900|NCT01159938|O6|Outcome|T2DM With Normal UAER (Low Postprandial Glucose)|T2DM participants with normal UAER who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875901|NCT01159938|O5|Outcome|T2DM With Normal UAER (High Postprandial Glucose)|T2DM participants with normal UAER who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875902|NCT01159938|O4|Outcome|T2DM With Albuminuria (Low Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875903|NCT01159938|O3|Outcome|T2DM With Albuminuria (High Postprandial Glucose)|T2DM participants with abnormal UAER (albuminuria) but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day).
875904|NCT01159938|O2|Outcome|T2DM Overall (Low Postprandial Glucose)|T2DM participants with normal UAER and T2DM participants with abnormal UAER (albuminuria) but normal kidney function who were scheduled to receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first or second study period (low postprandial glucose day). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant’s normal breakfast and standard basal insulin dose.
875905|NCT01159938|O1|Outcome|T2DM Overall (High Postprandial Glucose)|T2DM participants with normal urinary albumin excretion rate (UAER) and T2DM participants with abnormal UAER [albuminuria (defined as urinary albumin)] but normal kidney function who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast either in the first or second study period (high postprandial glucose day). Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875906|NCT01159938|E3|Reported Event|T2DM With Normal UAER|T2DM participants with normal UAER who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
875928|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
876497|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
875907|NCT01159938|E2|Reported Event|T2DM With Albuminuria|T2DM participants with abnormal UAER [albuminuria(defined as urinary albumin)] but normal kidney function who received an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (low to high sequence) or participants who did not receive an insulin lispro subcutaneous injection prior to a standard breakfast in the first study period and who received an insulin lispro subcutaneous injection prior to a standard breakfast in the second study period (high to low sequence). The dosage of insulin lispro was adjusted as needed based on the energy content of the participant's normal breakfast and standard basal insulin dose.
875908|NCT01159938|E1|Reported Event|Healthy Participants|Healthy participants with normal glucose tolerance and normal urinary albumin excretion rate (UAER) did not receive an insulin lispro subcutaneous injection but participated in study assessments. Normal glucose tolerance according to World Health Organization (WHO) criteria was defined as fasting glucose <6.1 millimoles/liter (mmol/L) and 2-hour glucose <7.8 mmol/L. Normal UAER was defined as <20 micrograms per minute (mcg/min) of albumin in the overnight urine collection or <30 milligrams per 24 hours (mg/24h) of albumin in the 24-hour urine collection.
875909|NCT01159912|B4|Baseline|Total|Total of all reporting groups
875910|NCT01159912|B3|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875911|NCT01159912|B2|Baseline|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875912|NCT01159912|B1|Baseline|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875913|NCT01159912|P3|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875914|NCT01159912|P2|Participant Flow|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875915|NCT01159912|P1|Participant Flow|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875916|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875917|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875918|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875919|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875920|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875921|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875922|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875923|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875924|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875925|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875926|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
877287|NCT01155219|B3|Baseline|Total|Total of all reporting groups
875929|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875930|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875931|NCT01159912|O3|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875932|NCT01159912|O2|Outcome|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875933|NCT01159912|O1|Outcome|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875934|NCT01159912|E3|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID via the DISKUS/ACCUHALER plus placebo via a DPI OD in the evening (total daily dose of 500 µg) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875935|NCT01159912|E2|Reported Event|FF 100 µg OD|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875936|NCT01159912|E1|Reported Event|Placebo|Participants received placebo via a dry powder inhaler (DPI) once daily (OD) in the evening and placebo via the DISKUS/ACCUHALER twice daily (BID) for 24 weeks (168 days). In addition, all participants were provided with albuterol/salbutamol aerosol to be used as rescue medication as needed.
875937|NCT01159769|B1|Baseline|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
875938|NCT01159769|P1|Participant Flow|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
875939|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
875940|NCT01159769|O1|Outcome|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
875941|NCT01159769|E1|Reported Event|Olopatadine 0.2%|1 drop self-administered in each eye once daily in the morning for 7 days
875942|NCT01159743|B3|Baseline|Total|Total of all reporting groups
875943|NCT01159743|B2|Baseline|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875944|NCT01159743|B1|Baseline|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875945|NCT01159743|P2|Participant Flow|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875946|NCT01159743|P1|Participant Flow|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875947|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875948|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875949|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875950|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875951|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875952|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875953|NCT01159743|O2|Outcome|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875954|NCT01159743|O1|Outcome|Efavirenz|Human Immunodeficiency Virus 1 (HIV-1)-infected patients on initial and continuous antiretroviral therapy for at least two years with efavirenz (Sustiva®; EFV) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875955|NCT01159743|E2|Reported Event|Lopinavir / Ritonavir|HIV-infected patients on initial and continuous antiretroviral therapy for at least two years with lopinavir/ritonavir (Kaletra®; LPV/r) with a combination of tenofovir (TDF) plus emtricitabine (FTC) or lamivudine (3TC).
875957|NCT01159691|B1|Baseline|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
875958|NCT01159691|P1|Participant Flow|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
875959|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
875960|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
875961|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
875962|NCT01159691|O1|Outcome|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
875963|NCT01159691|E1|Reported Event|Neupro|Routine treatment as per approved label in Europe/ in accordance with the terms of the local marketing authorization for Neupro® transdermal patch.
875964|NCT01159665|B7|Baseline|Total|Total of all reporting groups
875965|NCT01159665|B6|Baseline|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
875966|NCT01159665|B5|Baseline|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
875967|NCT01159665|B4|Baseline|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
875968|NCT01159665|B3|Baseline|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
875969|NCT01159665|B2|Baseline|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
875970|NCT01159665|B1|Baseline|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
875971|NCT01159665|P6|Participant Flow|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
875972|NCT01159665|P5|Participant Flow|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
875973|NCT01159665|P4|Participant Flow|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
875974|NCT01159665|P3|Participant Flow|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
875975|NCT01159665|P2|Participant Flow|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
875976|NCT01159665|P1|Participant Flow|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
875977|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
875978|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
875979|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
875980|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
875981|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
875982|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
875983|NCT01159665|O6|Outcome|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
875984|NCT01159665|O5|Outcome|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
875985|NCT01159665|O4|Outcome|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
875986|NCT01159665|O3|Outcome|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
875987|NCT01159665|O2|Outcome|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
875988|NCT01159665|O1|Outcome|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
875989|NCT01159665|E6|Reported Event|PPV Without Injection|Control Arm, no ocriplasmin intravitreal injection
875990|NCT01159665|E5|Reported Event|PPV 7 Days (+1 Day) After Injection|Primary Pars Plana Vitrectomy 7 days (+1 day)after 125ug of ocriplasmin intravitreal injection
875991|NCT01159665|E4|Reported Event|PPV 24 Hours (+2 Hours) After Injection|Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125ug of ocriplasmin intravitreal injection
875992|NCT01159665|E3|Reported Event|PPV 2-4 Hours After Injection|Primary Pars Plana Vitrectomy 2 to 4 hours after 125ug of ocriplasmin intravitreal injection
875993|NCT01159665|E2|Reported Event|PPV 31-60 Minutes After Injection|Primary Pars Plana Vitrectomy 31 to 60 minutes after 125ug of ocriplasmin intravitreal injection
875994|NCT01159665|E1|Reported Event|PPV 5-30 Minutes After Injection|Primary Pars Plana Vitrectomy 5 to 30 minutes after 125ug of ocriplasmin intravitreal injection
875995|NCT01159600|B9|Baseline|Total|Total of all reporting groups
875996|NCT01159600|B8|Baseline|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
875997|NCT01159600|B7|Baseline|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
875998|NCT01159600|B6|Baseline|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
875999|NCT01159600|B5|Baseline|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876287|NCT01157351|B3|Baseline|Total|Total of all reporting groups
877322|NCT01155154|P3|Participant Flow|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
876000|NCT01159600|B4|Baseline|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876001|NCT01159600|B3|Baseline|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876002|NCT01159600|B2|Baseline|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
876003|NCT01159600|B1|Baseline|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
876004|NCT01159600|P8|Participant Flow|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876005|NCT01159600|P7|Participant Flow|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876006|NCT01159600|P6|Participant Flow|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876007|NCT01159600|P5|Participant Flow|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876008|NCT01159600|P4|Participant Flow|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876009|NCT01159600|P3|Participant Flow|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876010|NCT01159600|P2|Participant Flow|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
876011|NCT01159600|P1|Participant Flow|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
876012|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876013|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876014|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876015|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876016|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876017|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876018|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
876019|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
876020|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876021|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876022|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876023|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876024|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876025|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876026|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
876027|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks, in patients with background medication of metformin only.
876028|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876029|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876030|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876031|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876032|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876033|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876034|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
876035|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
876036|NCT01159600|O8|Outcome|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876037|NCT01159600|O7|Outcome|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876038|NCT01159600|O6|Outcome|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876039|NCT01159600|O5|Outcome|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876040|NCT01159600|O4|Outcome|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876041|NCT01159600|O3|Outcome|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876042|NCT01159600|O2|Outcome|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
876043|NCT01159600|O1|Outcome|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
876044|NCT01159600|E8|Reported Event|Met+SU: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876045|NCT01159600|E7|Reported Event|Met+SU: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876046|NCT01159600|E6|Reported Event|Met+SU: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876047|NCT01159600|E5|Reported Event|Met+SU: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin plus sulphonylurea (SU).
876048|NCT01159600|E4|Reported Event|Met: Empa 25mg Open Label|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876049|NCT01159600|E3|Reported Event|Met: Empa 25mg|Single oral dose of empagliflozin (empa) 25mg taken once daily for 24 weeks in patients with background medication of metformin only.
876050|NCT01159600|E2|Reported Event|Met: Empa 10mg|Single oral dose of empagliflozin (empa) 10mg taken once daily for 24 weeks in patients with background medication of metformin only.
876051|NCT01159600|E1|Reported Event|Met: Placebo|A placebo tablet, matching the empagliflozin 10mg and 25mg tablets, taken once daily for 24 weeks in patients with background medication of metformin only.
876052|NCT01159574|B1|Baseline|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
876053|NCT01159574|P1|Participant Flow|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
876054|NCT01159574|O1|Outcome|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
876055|NCT01159574|E1|Reported Event|All Patients|"ClaPd therapy:~Dexamethasone (40mg ) will be given on days 1, 8, 15, 22 of a 28-day cycle. Clarithromycin (Biaxin®) will be given orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle.~Pomalidomide will be given 4mg daily for days 1-21 of each 28 day cycle. Dosing will be in the morning at approximately the same time each day.~dexamethasone: 40mg will be given on days 1, 8, 15, 22 of a 28-day cycle~clarithromycin: orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle~Pomalidomide: orally 4mg daily for days 1-21 of each 28 day cycle"
876056|NCT01159535|B4|Baseline|Total|Total of all reporting groups
876057|NCT01159535|B3|Baseline|Treatment as Usual|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
876058|NCT01159535|B2|Baseline|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
876389|NCT01157169|B2|Baseline|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
876059|NCT01159535|B1|Baseline|Mindfulness Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
876060|NCT01159535|P3|Participant Flow|Treatment as Usual (TAU)|"All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.~Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis."
876061|NCT01159535|P2|Participant Flow|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
876062|NCT01159535|P1|Participant Flow|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
876063|NCT01159535|O3|Outcome|Treatment as Usual (TAU)|Treatment as Usual included continuing care services (including attendance at Alcoholics Anonymous, Narcotics Anonymous, or other self-help groups) as recommended by their treatment providers.
876064|NCT01159535|O2|Outcome|Relapse Prevention (RP)|The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.
876065|NCT01159535|O1|Outcome|Mindfulness Based Relapse Prevention (MBRP)|"Mindfulness Based Relapse Prevention~Mindfulness Based Relapse Prevention: The MBRP intervention consisted of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments."
876066|NCT01159535|E3|Reported Event|Treatment as Usual (TAU)|Treatment as Usual participants were enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants received ongoing support and monitoring by their continuing care providers on a regular basis.
876067|NCT01159535|E2|Reported Event|Relapse Prevention (RP)|"The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions were team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.~Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)"
876068|NCT01159535|E1|Reported Event|Mindfulness-Based Relapse Prevention (MBRP)|Mindfulness Based Relapse Prevention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
876069|NCT01159431|B3|Baseline|Total|Total of all reporting groups
876070|NCT01159431|B2|Baseline|Control|Trigeminal Nerve Stimulation-Low Settings
876071|NCT01159431|B1|Baseline|Active|Trigeminal Nerve Stimulation-High Settings
876072|NCT01159431|P2|Participant Flow|Control|Trigeminal Nerve Stimulation-Low Settings
876073|NCT01159431|P1|Participant Flow|Active|Trigeminal Nerve Stimulation-High Settings
876074|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
876075|NCT01159431|O1|Outcome|Active|Trigeminal Nerve Stimulation-High Settings
876076|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
876077|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
876078|NCT01159431|O2|Outcome|Control|
876079|NCT01159431|O1|Outcome|Treatment|
876080|NCT01159431|O4|Outcome|Treatment Group-Double Blind Period|
876081|NCT01159431|O3|Outcome|Treatment Group-Baseline|
876082|NCT01159431|O2|Outcome|Control Group-Double Blind Period|Sham Treatment
876083|NCT01159431|O1|Outcome|Control Group-Baseline|Baseline
876084|NCT01159431|O2|Outcome|Control|Trigeminal Nerve Stimulation-Low Settings
876085|NCT01159431|O1|Outcome|Treatment|Trigeminal Nerve Stimulation-High Settings
876086|NCT01159431|E2|Reported Event|Control|Trigeminal Nerve Stimulation-Low Settings
876087|NCT01159431|E1|Reported Event|Active|Trigeminal Nerve Stimulation-High Settings
876088|NCT01159262|B4|Baseline|Total|Total of all reporting groups
876089|NCT01159262|B3|Baseline|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876090|NCT01159262|B2|Baseline|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876091|NCT01159262|B1|Baseline|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876092|NCT01159262|P3|Participant Flow|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876093|NCT01159262|P2|Participant Flow|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876094|NCT01159262|P1|Participant Flow|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876095|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876096|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876097|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876098|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876099|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876100|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876101|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876102|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876103|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876104|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876105|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876106|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876107|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876108|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876109|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876110|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876111|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876112|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876113|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876114|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
877545|NCT01154296|B3|Baseline|Total|Total of all reporting groups
876115|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876116|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876117|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876118|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876119|NCT01159262|O3|Outcome|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876120|NCT01159262|O2|Outcome|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876121|NCT01159262|O1|Outcome|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876122|NCT01159262|E3|Reported Event|Dexmedetomidine 0.2 mcg/kg|"Dexmedetomidine loading dose 0.2 mcg/kg; maintenance infusion 0.2 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876123|NCT01159262|E2|Reported Event|Dexmedetomidine 0.1 mcg/kg|"Dexmedetomidine loading dose: 0.1 mcg/kg; maintenance infusion 0.1 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876124|NCT01159262|E1|Reported Event|Dexmedetomidine 0.05 mcg/kg|"Dexmedetomidine loading dose 0.05 mcg/kg; maintenance infusion: 0.05 mcg/kg/hr.~Midazolam: Per package insert, N-PASS scores and investigator discretion~Fentanyl: Per package insert, N-PASS scores and investigator discretion.~Dexmedetomidine"
876125|NCT01159171|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876126|NCT01159171|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 milligrams per kilograms (mg/kg) intravenously (IV) on Days 1 and 15; oxaliplatin 40 mg per square meter (mg/m^2) IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 orally (PO) twice daily (BID) on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876127|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876128|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876129|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876130|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876131|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876132|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876133|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876134|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Cycle 1 (28-Day Cycle) Participants received 5 milligrams/kilograms (mg/kg) bevacizumab intravenously (IV) on Days 1 and 15; 40 mg/meter^2 (mg/m^2) oxaliplatin IV on Days 1, 8, 15, and 22; and 2000 mg/m^2 capecitabine orally (PO) in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14 followed by a rest period on Days 15 through 28. Cycle 1 was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876135|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876136|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876137|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876138|NCT01159171|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876139|NCT01159171|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 5 mg/kg IV on Days 1 and 15; oxaliplatin 40 mg/m^2 IV on Days 1, 8, 15, and 22; and capecitabine 1000 mg/m^2 PO BID on Days 1 through 14 followed by 2 weeks without treatment. This cycle was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
876140|NCT01157845|B1|Baseline|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
876141|NCT01157845|P1|Participant Flow|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
876142|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
876143|NCT01157845|O1|Outcome|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
876144|NCT01157845|E1|Reported Event|Laboratory Assay|BreathID (Methacetin breath test): 13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
876145|NCT01158924|B3|Baseline|Total|Total of all reporting groups
876146|NCT01158924|B2|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876147|NCT01158924|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876148|NCT01158924|P2|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876149|NCT01158924|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876150|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876151|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876152|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876153|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876154|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876155|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876156|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
892143|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
876157|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876158|NCT01158924|O2|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876159|NCT01158924|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876160|NCT01158924|E2|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876161|NCT01158924|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
876162|NCT01158716|B3|Baseline|Total|Total of all reporting groups
876163|NCT01158716|B2|Baseline|Control|
876164|NCT01158716|B1|Baseline|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
876165|NCT01158716|P2|Participant Flow|Control|
876166|NCT01158716|P1|Participant Flow|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
876167|NCT01158716|O2|Outcome|Control|
876168|NCT01158716|O1|Outcome|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
876169|NCT01158716|E2|Reported Event|Control|
876170|NCT01158716|E1|Reported Event|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning: Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
876171|NCT01158703|B3|Baseline|Total|Total of all reporting groups
876172|NCT01158703|B2|Baseline|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876173|NCT01158703|B1|Baseline|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876174|NCT01158703|P2|Participant Flow|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876175|NCT01158703|P1|Participant Flow|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876176|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876177|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876178|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876179|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876180|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876181|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876182|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876183|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876184|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876185|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876186|NCT01158703|O2|Outcome|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876187|NCT01158703|O1|Outcome|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876188|NCT01158703|E2|Reported Event|Sugar Pill|"aspirin and placebo~sugar pill: sugar pill and aspirin 81mg by mouth daily for 12 months"
876189|NCT01158703|E1|Reported Event|Clopidogrel|"aspirin and clopidogrel~clopidogrel: clopidogrel 75mg daily and aspirin 81mg by mouth daily for 12 months"
876190|NCT01158534|B1|Baseline|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876191|NCT01158534|P1|Participant Flow|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876192|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876193|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876194|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876195|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876196|NCT01158534|O1|Outcome|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876197|NCT01158534|E1|Reported Event|Celecoxib and Recombinant Interferon Alpha-2b|Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
876198|NCT01158378|B3|Baseline|Total|Total of all reporting groups
876199|NCT01158378|B2|Baseline|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
876200|NCT01158378|B1|Baseline|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
876201|NCT01158378|P2|Participant Flow|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
876202|NCT01158378|P1|Participant Flow|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
876203|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
876204|NCT01158378|O1|Outcome|Adherus Dural Sealant|Adherus Dural Sealant: In situ polymerizing sealant
876205|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
876206|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
876207|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
876208|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
876209|NCT01158378|O2|Outcome|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
876210|NCT01158378|O1|Outcome|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
876211|NCT01158378|E2|Reported Event|DuraSeal Dural Sealant System|DuraSeal Dural Sealant System: In situ polymerizing sealant
876212|NCT01158378|E1|Reported Event|Adherus Dural Sealant System|Adherus Dural Sealant: In situ polymerizing sealant
876213|NCT01158261|B1|Baseline|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
876214|NCT01158261|P1|Participant Flow|EVICEL® Fibrin Sealant (Human)|All procedures were performed according to the surgeon’s standard of care. EVICEL® Fibrin Sealant was prepared and used according to the current approved instructions for use and product indication. The anastomoses were constructed and checked for bleeding. Anastomotic repair sutures were placed and then, if bleeding requiring adjunctive treatment persisted, arterial clamps were re-applied. The surgeon then applied EVICEL® by dripping onto the anastomotic site/s according to his/her standard practice. Arterial clamps were removed approximately 1-minute following the end of product application to allow for curing. All subjects were followed for approximately 4 weeks following surgery.
876215|NCT01158261|O1|Outcome|EVICEL® Fibrin Sealant (Human)|
876216|NCT01158261|E1|Reported Event|EVICEL® Fibrin Sealant (Human)|"An adverse event (AE) was defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of the EVICEL® product. For the purpose of this protocol, an AE was any untoward medical occurrence in a study subject that may be related or possibly related to the EVICEL® product. The relatedness to EVICEL® was based on the investigator’s assessment.~In the original version of the protocol, the SAE definition did not require that the AE be related or possibly related to the treatment. This discrepancy with the AE definition resulted in the sites reporting non-EVICEL® related AEs and SAEs prior to the amended protocol implementation."
876217|NCT01158118|B3|Baseline|Total|Total of all reporting groups
876218|NCT01158118|B2|Baseline|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876219|NCT01158118|B1|Baseline|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
876220|NCT01158118|P2|Participant Flow|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876221|NCT01158118|P1|Participant Flow|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
876222|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876223|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876224|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876225|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876226|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876227|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876228|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876229|NCT01158118|O1|Outcome|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876230|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
876231|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
876232|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
876233|NCT01158118|O1|Outcome|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
876234|NCT01158118|E2|Reported Event|Arm 2 - Recipient|"Conditioning Regimens~fludarabine and busulfan +/- thymoglobulin~fractionated total body irradiation and cyclophosphamide~busulfan and cyclophosphamide~single dose total body irradiation and cyclophosphamide~Day -2 = GvHD prophylaxis~Day 0 or +1 = PBSC transplant~Day +7 until neutrophil engraftment = G-CSF 5 ug/kg/day"
876235|NCT01158118|E1|Reported Event|Arm 1 - Donor|"Days 1-5: Mobilization with 5 mcg/kg/day GM-CSF (first 4 donors were mobilized with 10 mcg/kg GM-CSF then changed to 5 mcg/kg for remaining donors)~Day 5: Mobilization with 320 mcg/kg plerixafor IV~Day 5: Leukopheresis~If PBSC collected are not adequate, then donor will be mobilized with GM-CSF and plerixafor IV on day 6 and have leukopheresis collection on day 6."
876236|NCT01157533|B1|Baseline|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
876237|NCT01157533|P1|Participant Flow|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
876238|NCT01157533|O1|Outcome|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
876239|NCT01157533|E1|Reported Event|Vancomycin Loading|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
876240|NCT01157429|B3|Baseline|Total|Total of all reporting groups
876241|NCT01157429|B2|Baseline|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876242|NCT01157429|B1|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876243|NCT01157429|P2|Participant Flow|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876244|NCT01157429|P1|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876245|NCT01157429|O2|Outcome|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
876491|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876246|NCT01157429|O1|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876247|NCT01157429|E2|Reported Event|Placebo Pill|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol."
876248|NCT01157429|E1|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876249|NCT01157416|B3|Baseline|Total|Total of all reporting groups
876250|NCT01157416|B2|Baseline|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876251|NCT01157416|B1|Baseline|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876252|NCT01157416|P2|Participant Flow|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876253|NCT01157416|P1|Participant Flow|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876254|NCT01157416|O2|Outcome|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876255|NCT01157416|O1|Outcome|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876256|NCT01157416|E2|Reported Event|Placebo Plus CBT|"Individuals receive 12 sessions of trauma-focused cognitive behavioral therapy plus seven doses of placebo pill.~Placebo pill: Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876257|NCT01157416|E1|Reported Event|D-cycloserine Plus CBT|"Individuals receive 12 sessions of manualized trauma-focused cognitive behavioral therapy plus seven doses of D-cycloserine.~D-cycloserine: D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol."
876258|NCT01157377|B8|Baseline|Total|Total of all reporting groups
876259|NCT01157377|B7|Baseline|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
876260|NCT01157377|B6|Baseline|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
876261|NCT01157377|B5|Baseline|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
876262|NCT01157377|B4|Baseline|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
876263|NCT01157377|B3|Baseline|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
876264|NCT01157377|B2|Baseline|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
876265|NCT01157377|B1|Baseline|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
876266|NCT01157377|P7|Participant Flow|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
876267|NCT01157377|P6|Participant Flow|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
876268|NCT01157377|P5|Participant Flow|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
876269|NCT01157377|P4|Participant Flow|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
876270|NCT01157377|P3|Participant Flow|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
876271|NCT01157377|P2|Participant Flow|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
876272|NCT01157377|P1|Participant Flow|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
876273|NCT01157377|O7|Outcome|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
876274|NCT01157377|O6|Outcome|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
876275|NCT01157377|O5|Outcome|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
876276|NCT01157377|O4|Outcome|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
876277|NCT01157377|O3|Outcome|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
876278|NCT01157377|O2|Outcome|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
876279|NCT01157377|O1|Outcome|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
876280|NCT01157377|E7|Reported Event|Placebo to AGN-214868|Placebo to AGN-214868 injected into the bladder on Day 1.
876281|NCT01157377|E6|Reported Event|AGN-214868 Total Dose 60000 ng|AGN-214868 injected into the bladder for total dose of 60000 ng on Day 1.
876282|NCT01157377|E5|Reported Event|AGN-214868 Total Dose 18000 ng|AGN-214868 injected into the bladder for total dose of 18000 ng on Day 1.
876283|NCT01157377|E4|Reported Event|AGN-214868 Total Dose 6000 ng|AGN-214868 injected into the bladder for total dose of 6000 ng on Day 1.
876284|NCT01157377|E3|Reported Event|AGN-214868 Total Dose 2000 ng|AGN-214868 injected into the bladder for total dose of 2000 ng on Day 1.
876285|NCT01157377|E2|Reported Event|AGN-214868 Total Dose 1000 ng|AGN-214868 injected into the bladder for total dose of 1000 ng on Day 1.
876286|NCT01157377|E1|Reported Event|AGN-214868 Total Dose 500 ng|AGN-214868 injected into the bladder for total dose of 500 ng on Day 1.
876288|NCT01157351|B2|Baseline|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876289|NCT01157351|B1|Baseline|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876290|NCT01157351|P2|Participant Flow|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876291|NCT01157351|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876292|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876293|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876294|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876295|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876296|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876297|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876298|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876299|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876300|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876301|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876302|NCT01157351|O2|Outcome|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876303|NCT01157351|O1|Outcome|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876304|NCT01157351|E2|Reported Event|Oral Antipsychotics|One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
876305|NCT01157351|E1|Reported Event|Paliperidone Palmitate|Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator’s discretion starting on Day 38 up to 15 months.
876306|NCT01157234|B3|Baseline|Total|Total of all reporting groups
876307|NCT01157234|B2|Baseline|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876308|NCT01157234|B1|Baseline|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876309|NCT01157234|P2|Participant Flow|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876310|NCT01157234|P1|Participant Flow|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876311|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876312|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876313|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876314|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876342|NCT01157182|P2|Participant Flow|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
876315|NCT01157234|O2|Outcome|Metoprolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876316|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876317|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients age less than 50 years treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876318|NCT01157234|O1|Outcome|Nebivolol >/=50 Years Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876319|NCT01157234|O2|Outcome|Metoprolol <50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876320|NCT01157234|O1|Outcome|Nebivolol < 50 Years Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876321|NCT01157234|O2|Outcome|Metoprolol >/= 50 Year Old|Hypertensive kidney transplant recipients age 50 years or higher treated with Metoprolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
876322|NCT01157234|O1|Outcome|Nebivolol <50 Year Old|Hypertensive kidney transplant recipients less than 50 years of age treated with Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study
876323|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876324|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876325|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876326|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876327|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876328|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876329|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876330|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876331|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876332|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876333|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876334|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876335|NCT01157234|O2|Outcome|Metoprolol|Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876336|NCT01157234|O1|Outcome|Nebivolol|Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.
876337|NCT01157234|E2|Reported Event|Metoprolol|"Metoprolol starting dose of 25mg orally once twice daily, titrated to a maximum total daily dose of 400 mg to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Metoprolol: Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90."
876338|NCT01157234|E1|Reported Event|Nebivolol|"Nebivolol starting dose of 5 mg orally once daily, titrated to a maximum total daily dose of 40 mg daily to achieve a target blood pressure of <140/90 and continued until month-12 of the study.~Nebivolol: Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90."
876339|NCT01157182|B3|Baseline|Total|Total of all reporting groups
876340|NCT01157182|B2|Baseline|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
876341|NCT01157182|B1|Baseline|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
876343|NCT01157182|P1|Participant Flow|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
876344|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876345|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876346|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876347|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876348|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876349|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876350|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876351|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876352|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876353|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876354|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876355|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876356|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876357|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876358|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876359|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876360|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876361|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876362|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876363|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876364|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876365|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876366|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876367|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876368|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876369|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876370|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876371|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876372|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876373|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876374|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876375|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876376|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876377|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876378|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876379|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876380|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876381|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876382|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876383|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876384|NCT01157182|O2|Outcome|Activella® (Reference)|1/0.5 mg Activella® Tablets reference product dosed in either period.
876385|NCT01157182|O1|Outcome|Estradiol/Norethindrone Acetate (Test)|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in either period.
876386|NCT01157182|E2|Reported Event|Activella® (Reference) First|1/0.5 mg Activella® Tablets reference product dosed in first period followed by 1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in the second period.
876387|NCT01157182|E1|Reported Event|Estradiol/Norethindrone Acetate (Test) First|1/0.5 mg Estradiol/Norethindrone acetate Tablets test product dosed in first period followed by 1/0.5 mg Activella® Tablets reference product dosed in the second period.
876388|NCT01157169|B3|Baseline|Total|Total of all reporting groups
876709|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876390|NCT01157169|B1|Baseline|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
876391|NCT01157169|P2|Participant Flow|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
876392|NCT01157169|P1|Participant Flow|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
876393|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
876394|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
876395|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
876396|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
876397|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
876398|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
876399|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
876400|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
876401|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
876402|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
876403|NCT01157169|O2|Outcome|Subutex® (Reference)|8 mg Subutex® Sublingual Tablets reference product dosed in either period.
876404|NCT01157169|O1|Outcome|Buprenorphine (Test)|8 mg Buprenorphine Sublingual Tablets test product dosed in either period.
876405|NCT01157169|E2|Reported Event|Subutex® (Reference) First|8 mg Subutex® Sublingual Tablets reference product dosed in first period followed by 8 mg Buprenorphine Sublingual Tablets test product dosed in the second period.
876406|NCT01157169|E1|Reported Event|Buprenorphine (Test) First|8 mg Buprenorphine Sublingual Tablets test product dosed in first period followed by 8 mg Subutex® Sublingual Tablets reference product dosed in the second period.
876407|NCT01157117|B4|Baseline|Total|Total of all reporting groups
876408|NCT01157117|B3|Baseline|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876409|NCT01157117|B2|Baseline|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876410|NCT01157117|B1|Baseline|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876411|NCT01157117|P3|Participant Flow|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876412|NCT01157117|P2|Participant Flow|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876413|NCT01157117|P1|Participant Flow|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876414|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876415|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
892144|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
876416|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876417|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876418|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876419|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876420|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876421|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876422|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876423|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876424|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876425|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876426|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876427|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876492|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876493|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876494|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876710|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876428|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876429|NCT01157117|O3|Outcome|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876430|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876431|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876432|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876433|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876434|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876435|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876436|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876437|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876438|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876711|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876439|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876440|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876441|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876442|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876443|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876444|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876445|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876446|NCT01157117|O2|Outcome|Placebo for Omalizumab/Milk OIT|Participants receive blinded placebo for omalizumab injections every 2 to 4 weeks through Month 16; after unblinding the injections are discontinued. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC; if they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876447|NCT01157117|O1|Outcome|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876448|NCT01157117|E3|Reported Event|Untreated Control|Participants did not receive any study intervention but provided regular blood draws at specific study time points to allow mechanistic comparisons with the participants in the other two groups who did receive study intervention.
876449|NCT01157117|E2|Reported Event|Placebo for Omalizumab/Milk OIT|Placebo for omalizumab: Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the omalizumab treatment group (determined by the participant's IgE level and weight).
876495|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876496|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876712|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876450|NCT01157117|E1|Reported Event|Omalizumab/Milk OIT|Participants receive blinded omalizumab injections every 2 to 4 weeks through Month 16 and unblinded omalizumab injections thereafter until the Month 28 desensitization OFC. Participants ingest milk powder daily starting at Month 4 with a dose of 0.07 mg milk protein and escalate for 22 to 40 weeks until reaching the maintenance dose of 3.84 g milk protein (minimum required maintenance dose is 520 mg milk protein). At Month 28 participants complete a 10g milk OFC and discontinue omalizumab injections. If they fail the OFC they permanently discontinue ingestion of the milk powder; if they pass the OFC they continue ingestion of the maintenance dose of milk powder through Month 30 and then discontinue it.
876451|NCT01157078|B3|Baseline|Total|Total of all reporting groups
876452|NCT01157078|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876453|NCT01157078|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876454|NCT01157078|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876455|NCT01157078|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876456|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876457|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876458|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876459|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876460|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876461|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876462|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876463|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876464|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876465|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876466|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876467|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876468|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876469|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876470|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876471|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876472|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876473|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876474|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876475|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876476|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876477|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876478|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876479|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876480|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876481|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876482|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876483|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876484|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876485|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876486|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876487|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876488|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876489|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876490|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876498|NCT01157078|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876499|NCT01157078|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876500|NCT01157078|E2|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
876501|NCT01157078|E1|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
876502|NCT01157065|B3|Baseline|Total|Total of all reporting groups
876503|NCT01157065|B2|Baseline|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876504|NCT01157065|B1|Baseline|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876505|NCT01157065|P2|Participant Flow|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876506|NCT01157065|P1|Participant Flow|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876507|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876508|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876509|NCT01157065|O2|Outcome|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876510|NCT01157065|O1|Outcome|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876511|NCT01157065|E2|Reported Event|Lucentis|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876512|NCT01157065|E1|Reported Event|AL-78898A|Single 50-µL (microliter) intravitreal injection with 12 weeks follow-up
876513|NCT01156987|B3|Baseline|Total|Total of all reporting groups
876514|NCT01156987|B2|Baseline|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
876515|NCT01156987|B1|Baseline|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
876516|NCT01156987|P2|Participant Flow|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained. 10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
876517|NCT01156987|P1|Participant Flow|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
876518|NCT01156987|O2|Outcome|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
876530|NCT01156844|P1|Participant Flow|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876519|NCT01156987|O1|Outcome|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
876520|NCT01156987|E2|Reported Event|Breast Cancer Patients|"Breast cancer patients who have suspected breast lesion that will be biopsied will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compar"
876521|NCT01156987|E1|Reported Event|Healthy Volunteers|"Healthy women will be screened for Magnetic Resonance Imaging (MRI) contraindications, and then undergo contrast injection, and SWIFT acquisition.~Magnetic resonance imaging: Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:~an IV line is placed by nurse,~patient is placed in the 4 T MRI scanner at CMRR,~initial scout images and manual linear shims are adjusted,~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,~continuous SWIFT acquisition begins immediately before contrast injection,~contrast injection,~continuous SWIFT acquisition continues for 12 min after contrast,~late enhancement images may also be obtained.~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
876522|NCT01156844|B5|Baseline|Total|Total of all reporting groups
876523|NCT01156844|B4|Baseline|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876524|NCT01156844|B3|Baseline|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876525|NCT01156844|B2|Baseline|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876526|NCT01156844|B1|Baseline|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876527|NCT01156844|P4|Participant Flow|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876528|NCT01156844|P3|Participant Flow|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876529|NCT01156844|P2|Participant Flow|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876559|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876531|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
876532|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876533|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876534|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
876535|NCT01156844|O2|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876536|NCT01156844|O1|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876537|NCT01156844|O3|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) such as salbutamol/albuterol was available for rescue use throughout the study.
876538|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876539|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876540|NCT01156844|O4|Outcome|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876541|NCT01156844|O3|Outcome|Indacaterol 150 µg (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876542|NCT01156844|O2|Outcome|Indacaterol 75 µg (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876543|NCT01156844|O1|Outcome|Indacaterol 37.5 µg (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876713|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876714|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876544|NCT01156844|E4|Reported Event|Placebo|Placebo to Indacaterol twice daily (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876545|NCT01156844|E3|Reported Event|Indacaterol 150 ug (Every Other Day)|Indacaterol 150 µg every other day (qod) inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for a total of 16 days. Indacaterol 150 µg inhaled via Concept1, a SDDPI, in the morning and Placebo to Indacaterol inhaled via Concept1 in the evening on odd days; and Placebo to Indacaterol inhaled via Concept1 in the morning and in the evening on even days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876546|NCT01156844|E2|Reported Event|Indacaterol 75 ug (Once a Day)|Indacaterol 75 µg once a day (qd) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and Placebo to Indacaterol inhaled once daily via Concept1 in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876547|NCT01156844|E1|Reported Event|Indacaterol 37.5 ug (Twice a Day)|Indacaterol 37.5 µg twice a day (bid) inhaled via Concept1, a single dose dry powder inhaler (SDDPI), in the morning and in the evening for 16 days. All patients had to receive daily treatment with inhaled corticosteroid up to the maximum dose per day in a stable regimen for at least 4-weeks prior to screening and remain stable through out the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
876548|NCT01156792|B1|Baseline|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
876549|NCT01156792|P1|Participant Flow|All Treatments Combined|In a total of 4 treatment periods (each of 6 weeks - the first 3 weeks considered as active washout), participants received 4 of the 5 possible treatments (A/B/C/D/E) in a double-blind double-dummy, cross-over manner. Fluticasone propionate (FP) 100 µg oral inhalation was a part of each treatment. Added regimen were, A: GSK2190915 100 milligrams (mg) once daily (OD), B: GSK2190915 300 mg OD, C: montelukast 10 mg OD, D: placebo twice daily (BID), E: salmeterol 50 µg and placebo BID. Albuterol aerosol was provided as a rescue inhalation.
876550|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876551|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876552|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876553|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876554|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876555|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876556|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876557|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876558|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876715|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876560|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876561|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876562|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876563|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876564|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876565|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876566|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876567|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876568|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876569|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876570|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876571|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876572|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876573|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876574|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876575|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876576|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876716|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876717|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876577|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876578|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876579|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876580|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876581|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876582|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876583|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876584|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876585|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876586|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876587|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876588|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876589|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876590|NCT01156792|O3|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876591|NCT01156792|O2|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876592|NCT01156792|O1|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876593|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876635|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876594|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876595|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876596|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876597|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876598|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876599|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876600|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876601|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876602|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876603|NCT01156792|O5|Outcome|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876604|NCT01156792|O4|Outcome|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876605|NCT01156792|O3|Outcome|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876606|NCT01156792|O2|Outcome|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876607|NCT01156792|O1|Outcome|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876608|NCT01156792|E5|Reported Event|FP / Salmeterol|Participants received a combination of FP 100 µg and salmeterol 50 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets and PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876609|NCT01156792|E4|Reported Event|FP + Montelukast|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Montelukast 10 mg capsule administered PM was added to the dosing regimen. Blinding was maintained by AM administration of GSK2190915-matching placebo tablets. Albuterol aerosol was provided as a rescue inhalation.
876610|NCT01156792|E3|Reported Event|FP + GSK2190915 300 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 300 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876636|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876611|NCT01156792|E2|Reported Event|FP + GSK2190915 100 mg|Participants received FP 100 µg oral inhalation BID for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. GSK2190915 100 mg AM was added to the dosing regimen. Blinding was maintained by PM administration of a montelukast-matching placebo capsule. Albuterol aerosol was provided as a rescue inhalation.
876612|NCT01156792|E1|Reported Event|FP + Placebo|Participants received FP 100 µg oral inhalation twice daily (BID) for 6 weeks (first 3 weeks considered as active washout), in one of the 4 treatment periods. Placebo administered every morning (AM) was added to the dosing regimen. Blinding was maintained by administration of a montelukast-matching placebo capsule every evening (PM). Albuterol aerosol was provided as a rescue inhalation.
876613|NCT01156701|B1|Baseline|All Patients Included in the Analysis|All patients at least 5 years old enrolled for at least 6 months in the Normative Health Informatics (NHI) insurance claims database during the influenza seasons of 2006-2009
876614|NCT01156701|P4|Participant Flow|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876615|NCT01156701|P3|Participant Flow|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876616|NCT01156701|P2|Participant Flow|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876617|NCT01156701|P1|Participant Flow|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876618|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876619|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876620|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876621|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876622|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876623|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876624|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876625|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876626|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876627|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876628|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876629|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876630|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876631|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876632|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876633|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876634|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
878343|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
876637|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876638|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876639|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876640|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876641|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876642|NCT01156701|O4|Outcome|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876643|NCT01156701|O3|Outcome|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876644|NCT01156701|O2|Outcome|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876645|NCT01156701|O1|Outcome|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876646|NCT01156701|E4|Reported Event|Cohort 4: Untreated With Treated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received zanamivir on the day of or the day after the influenza diagnosis
876647|NCT01156701|E3|Reported Event|Cohort 3: Untreated With Untreated Index|Individuals not receiving zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive any antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876648|NCT01156701|E2|Reported Event|Cohort 2: Prophylaxis With Treated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and received antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876649|NCT01156701|E1|Reported Event|Cohort 1: Prophylaxis With Untreated Index|Individuals who received zanamivir prophylaxis and who had a household member who had a medical visit with a diagnosis of influenza and did not receive antiviral therapy (oseltamivir, rimantidine, amantidine, or zanamivir)
876650|NCT01156597|B3|Baseline|Total|Total of all reporting groups
876651|NCT01156597|B2|Baseline|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
876652|NCT01156597|B1|Baseline|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
876653|NCT01156597|P2|Participant Flow|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
876654|NCT01156597|P1|Participant Flow|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
876655|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
876656|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
876657|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
876658|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
876659|NCT01156597|O2|Outcome|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
876660|NCT01156597|O1|Outcome|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~The pioglitazone treatment regimen for this arm of the study: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
876661|NCT01156597|E2|Reported Event|Comparator Group|This group of subjects will be maintained on standard treatment with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level as group treated with pioglitazone.
876662|NCT01156597|E1|Reported Event|Pioglitazone Group|"This is a baseline versus treatment study comparing subjects on pioglitazone to a matched group of subjects treated with either metformin or sulfonylurea with the intent of controlling blood sugar to a comparable level~pioglitazone: 30 mg daily for three weeks increase to 45 mg daily for 21 more weeks"
876663|NCT01156571|B3|Baseline|Total|Total of all reporting groups
876664|NCT01156571|B2|Baseline|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
876665|NCT01156571|B1|Baseline|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
876666|NCT01156571|P2|Participant Flow|Clopidogrel Treatment Arm|"Oral clopidogrel was administered as soon as possible following randomization at investigator discretion at a loading dose of either 600 mg or 300 mg as specified by the investigator.~Patients in the clopidogrel treatment arm received IV placebo for 2 hours or end of the PCI procedure, whichever was longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~At the end of IV placebo infusion, patients were given oral placebo capsules matching the oral clopidogrel transition dose."
876667|NCT01156571|P1|Participant Flow|Cangrelor Treatment Arm|"Cangrelor was administered as a 30 µg/kg bolus followed by a 4.0 µg/kg/min cangrelor IV infusion for a minimum of 2 hours or until conclusion of the index procedure, whichever is longer. At the discretion of the treating physician, the infusion could be continued for a total duration of 4 hours.~Immediately after discontinuation of infusion, an oral transition dose of clopidogrel 600 mg was administered.~Patients also received oral placebo capsules, administered as soon as possible following randomization at investigator discretion. These capsules were designed to match the clopidogrel 600 mg or 300 mg loading dose."
876668|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
876669|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
876670|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
876671|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
876672|NCT01156571|O2|Outcome|Clopidogrel Treatment Arm|
876673|NCT01156571|O1|Outcome|Cangrelor Treatment Arm|
876674|NCT01156571|E2|Reported Event|Clopidogrel Treatment Arm|
876675|NCT01156571|E1|Reported Event|Cangrelor Treatment Arm|
876676|NCT01156532|B1|Baseline|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876677|NCT01156532|P1|Participant Flow|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876678|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876679|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876680|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876681|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876682|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876683|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876684|NCT01156532|O1|Outcome|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876685|NCT01156532|E1|Reported Event|Adalimumab Treatment in Participants With Psoriasis|Participants with moderate to severe chronic plaque psoriasis defined as Psoriasis Area and Severity Index (PASI) ≥ 10 and body surface area ≥ 10% with or without psoriatic arthritis, who have an adalimumab therapy indication because they are candidates for systemic therapy or phototherapy and other systemic therapies are medically less appropriate.
876686|NCT01156480|B3|Baseline|Total|Total of all reporting groups
876687|NCT01156480|B2|Baseline|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876688|NCT01156480|B1|Baseline|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876689|NCT01156480|P2|Participant Flow|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876690|NCT01156480|P1|Participant Flow|Hydrocortisone|hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous route for 3 days, then 2mg/kg/day divided every 8 hours IV for 1 day, then 1.5mg/kg/day divided every 8 hours IV for 1 day, then 1mg/kg/day divided every 12 hours for 1 day, then 0.5mg/kg/day in single dose for one day. Placebo group will receive equal volume of placebo on the same schedule. The first dose of study drug will be given within 6 hours of NEC diagnosis, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876691|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876692|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876693|NCT01156480|O2|Outcome|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876694|NCT01156480|O1|Outcome|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876695|NCT01156480|E2|Reported Event|Placebo|Subjects in placebo group will receive equal volume of placebo (as compared to hydrocortisone arm) on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876696|NCT01156480|E1|Reported Event|Hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via intravenous (IV) route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. Subjects in placebo group will receive equal volume of placebo on the same dosing schedule. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
876697|NCT01156376|B4|Baseline|Total|Total of all reporting groups
876698|NCT01156376|B3|Baseline|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876699|NCT01156376|B2|Baseline|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876700|NCT01156376|B1|Baseline|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876701|NCT01156376|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876702|NCT01156376|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876703|NCT01156376|P1|Participant Flow|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876704|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876705|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876706|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876707|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876708|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876718|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876719|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876720|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876721|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876722|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876723|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876724|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876725|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876726|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876727|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876728|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876729|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876730|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876731|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876732|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876733|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876734|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876735|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876736|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876737|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876738|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876739|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876740|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876741|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876742|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876743|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876744|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876745|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876746|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876747|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876748|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876749|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876750|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876751|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876752|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876753|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876754|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876755|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876756|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876757|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876758|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876759|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876760|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876761|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876762|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876763|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876764|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876765|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876766|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876767|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876768|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876769|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876770|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876771|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876772|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876773|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876774|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876775|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876776|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876777|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876778|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876779|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876780|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876781|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876782|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876783|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876784|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876785|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876786|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876787|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876788|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876789|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876790|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876791|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876792|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876793|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876794|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876795|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876796|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876797|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876798|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876799|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876800|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876801|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876802|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876803|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876804|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876805|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876806|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876807|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876808|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876809|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876810|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876811|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876812|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876813|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876814|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876815|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876816|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876817|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876818|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876819|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876820|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876821|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876822|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876823|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876824|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876825|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876826|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876827|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876828|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876829|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876830|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876831|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876832|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876833|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876834|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876835|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876836|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876837|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876838|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876839|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876840|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876841|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876842|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876843|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876844|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876845|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876846|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876847|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876848|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876849|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876850|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876851|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876852|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876853|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876854|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876855|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876856|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876857|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876858|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876859|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876860|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876861|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876862|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876863|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876864|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876865|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876866|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876867|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876868|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876869|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876870|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876871|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876872|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876873|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876874|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876875|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876876|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876877|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876878|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876879|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876880|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876881|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876882|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876883|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876884|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876885|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876886|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876887|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876888|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876889|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876890|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876891|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876892|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876893|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876894|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876895|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876896|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876897|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876898|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876899|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876900|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876901|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876902|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876903|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876904|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876905|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876906|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876907|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876908|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876909|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876910|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876911|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876912|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876913|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876914|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876915|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876916|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876917|NCT01156376|O3|Outcome|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876918|NCT01156376|O2|Outcome|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876919|NCT01156376|O1|Outcome|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876920|NCT01156376|E3|Reported Event|12027-020|1.40% Potassium Oxalate Mouth Rinse with Fluoride (20 mL)
876921|NCT01156376|E2|Reported Event|12027-019|1.40% Potassium Oxalate Mouth Rinse without Fluoride (10 mL)
876922|NCT01156376|E1|Reported Event|19292-116-A Control (Listerine®)|Cool Mint® Listerine® Antiseptic Mouth Rinse (20 mL)
876923|NCT01156363|B1|Baseline|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
876924|NCT01156363|P1|Participant Flow|Mircera|"Participants received Mircera (epoetin beta-methoxy polyethylene glycol) 80, 120, 200, or 360 micrograms (mcg) (based on the weekly dose of erythropoiesis stimulating agent [ESA] participant received in the week preceding the switch to Mircera [Week -1]) by intravenous (IV) or subcutaneous (SC) injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on hemoglobin (Hb) level.~This arm includes participants enrolled at all 3 centers."
876925|NCT01156363|O1|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
876926|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
876927|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
876928|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
876929|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at China Medical University Hospital (CMUH)."
876930|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
876931|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at BTCH."
876932|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at KMUH."
876933|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at CMUH."
876934|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
876935|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at BTCH."
876936|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at KMUH."
876937|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at CMUH."
876938|NCT01156363|O4|Outcome|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
876939|NCT01156363|O3|Outcome|Mircera - BTCH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Buddhist Tzu Chi General Hospital (BTCH)."
876940|NCT01156363|O2|Outcome|Mircera – KMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at Kaohsiung Medical University Chung-Ho Memorial Hospital (KMUH)."
876941|NCT01156363|O1|Outcome|Mircera – CMUH|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at China Medical University Hospital (CMUH)."
876942|NCT01156363|E1|Reported Event|Mircera|"Participants received Mircera 80, 120, 200, or 360 mcg (based on the weekly dose of ESA participant received in the week preceding the switch to Mircera [Week -1]) by IV or SC injection once monthly for a total of 32 weeks. Doses were adjusted, if required, based on Hb level.~This arm includes participants enrolled at all 3 centers."
876943|NCT01156311|B3|Baseline|Total|Total of all reporting groups
876944|NCT01156311|B2|Baseline|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876945|NCT01156311|B1|Baseline|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876946|NCT01156311|P4|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to GA|"Dimethyl fumarate was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).~Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study."
876947|NCT01156311|P3|Participant Flow|Add-on Therapy Period: Dimethyl Fumarate Add-on to IFNß|"BG00012 (dimethyl fumarate) was to be administered at 120 mg three times a day (TID) on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months) as an add-on to a stable dose of IFNß.~Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study."
876948|NCT01156311|P2|Participant Flow|Monotherapy Period: Glatiramer Acetate (GA)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
876949|NCT01156311|P1|Participant Flow|Monotherapy Period: Interferon Beta (IFNß)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
876950|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876951|NCT01156311|O1|Outcome|Interferon Beta 1a (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876952|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876953|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
877095|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
876954|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876955|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876956|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876957|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876958|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876959|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876960|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876961|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876962|NCT01156311|O2|Outcome|Glatiramer Acetate (GA) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876963|NCT01156311|O1|Outcome|Interferon Beta (IFNß) and BG00012 (Dimethyl Fumarate)|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876964|NCT01156311|O2|Outcome|Monotherapy Period: GA|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
876965|NCT01156311|O1|Outcome|Monotherapy Period: IFNß|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. The monotherapy period included the 8 weeks prior to the first dose of dimethyl fumarate.
876966|NCT01156311|E4|Reported Event|Add-on Therapy Period: GA and BG00012|Participants taking a stable dose of GA for at least 12 months prior to the study remained on that dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876967|NCT01156311|E3|Reported Event|Add-on Therapy Period: IFNß and BG00012|Participants taking a stable dose of one of the IFNß products for at least 12 months prior to the study remained on that product and dose throughout the study. BG00012 (dimethyl fumarate) was to be administered at 120 mg TID on Days 1-7, and 240 mg TID on Day 8 until the end of treatment (approximately 6 months).
876968|NCT01156311|E2|Reported Event|Monotherapy Period: GA|A stable dose of GA for up to 8 weeks (until the first dose of BG00012).
876969|NCT01156311|E1|Reported Event|Monotherapy Period: IFNß|A stable dose of one of the IFNß products for up to 8 weeks (until the first dose of BG00012).
876970|NCT01156142|B3|Baseline|Total|Total of all reporting groups
876971|NCT01156142|B2|Baseline|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876972|NCT01156142|B1|Baseline|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876973|NCT01156142|P2|Participant Flow|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876974|NCT01156142|P1|Participant Flow|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876975|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
877007|NCT01156051|P2|Participant Flow|Control|Children who received a matching placebo tablet administered once daily in the morning in a flexible dosing protocol, with tablets identical to guanfacine extended release from 1mg to 4mg.
876976|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876977|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876978|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876979|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876980|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876981|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876982|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876983|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876984|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876985|NCT01156142|O2|Outcome|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876986|NCT01156142|O1|Outcome|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876987|NCT01156142|E2|Reported Event|Arm II (Placebo-Doxepin)|Patients receive 2.5 mL placebo (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm I on day 2.
876988|NCT01156142|E1|Reported Event|Arm I (Doxepin-Placebo)|Patients receive (10 mg/mL x 2.5 mL) 25 mg doxepin hydrochloride (diluted to 5 mL with 2.5 mL of sterile water for irrigation, or sterile water for injection, or distilled water) oral rinse (swish, gargle, and spit) over 1 minute on day 1. Patients may crossover to arm II on day 2.
876989|NCT01156116|B3|Baseline|Total|Total of all reporting groups
876990|NCT01156116|B2|Baseline|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
876991|NCT01156116|B1|Baseline|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
876992|NCT01156116|P2|Participant Flow|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
876993|NCT01156116|P1|Participant Flow|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
876994|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
876995|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
876996|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
876997|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
876998|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
876999|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
877000|NCT01156116|O2|Outcome|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
877001|NCT01156116|O1|Outcome|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
877002|NCT01156116|E2|Reported Event|Placebo|2 weeks of oral administration of a placebo tablet 30min before bedtime
877003|NCT01156116|E1|Reported Event|Continuous Positive Airway Pressure|2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night
877004|NCT01156051|B3|Baseline|Total|Total of all reporting groups
877005|NCT01156051|B2|Baseline|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg were started and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
877006|NCT01156051|B1|Baseline|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets were started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
877053|NCT01155830|P2|Participant Flow|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
877008|NCT01156051|P1|Participant Flow|Treatment Group|Children who received (double blinded, randomized) guanfacine extended release tablets in a flexible dosing protocol, with doses ranging from 1mg to 4mg administered once daily in the morning.
877009|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
877010|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
877011|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
877012|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
877013|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
877014|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
877015|NCT01156051|O2|Outcome|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
877016|NCT01156051|O1|Outcome|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
877017|NCT01156051|E2|Reported Event|Placebo Comparator|"Placebo control~Placebo comparator: Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine)."
877018|NCT01156051|E1|Reported Event|Guanfacine Extended-Release Tablets|"Guanfacine Extended-Release Tablets 1mg, 2mg, 3mg, and 4mg~Guanfacine extended-release tablets: Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated"
877019|NCT01156012|B3|Baseline|Total|Total of all reporting groups
877020|NCT01156012|B2|Baseline|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
877021|NCT01156012|B1|Baseline|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
877022|NCT01156012|P2|Participant Flow|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
877023|NCT01156012|P1|Participant Flow|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm"
877024|NCT01156012|O2|Outcome|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
877025|NCT01156012|O1|Outcome|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
877026|NCT01156012|E2|Reported Event|Prostaglandin|"One drop of prostaglandin~Prostaglandin: One drop of prostaglandin at 9.00pm"
877027|NCT01156012|E1|Reported Event|T2345|"One drop of T2345~T2345: One drop of T2345 at 9.00pm."
877028|NCT01155999|B3|Baseline|Total|Total of all reporting groups
877029|NCT01155999|B2|Baseline|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
877030|NCT01155999|B1|Baseline|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
877031|NCT01155999|P2|Participant Flow|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
877032|NCT01155999|P1|Participant Flow|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
877033|NCT01155999|O2|Outcome|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
877034|NCT01155999|O1|Outcome|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
877035|NCT01155999|E2|Reported Event|Tobramycin|Tobramycin: 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
877036|NCT01155999|E1|Reported Event|T1225|T1225: one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
877037|NCT01155869|B3|Baseline|Total|Total of all reporting groups
877038|NCT01155869|B2|Baseline|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
877039|NCT01155869|B1|Baseline|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
877040|NCT01155869|P2|Participant Flow|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
877041|NCT01155869|P1|Participant Flow|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
877042|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
877043|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
877044|NCT01155869|O2|Outcome|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
877045|NCT01155869|O1|Outcome|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
877046|NCT01155869|E2|Reported Event|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
877047|NCT01155869|E1|Reported Event|XR-NTX|Depot naltrexone (Vivitrol) 380 mg. IM monthly
877048|NCT01155830|B4|Baseline|Total|Total of all reporting groups
877049|NCT01155830|B3|Baseline|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
877050|NCT01155830|B2|Baseline|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
877051|NCT01155830|B1|Baseline|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
877052|NCT01155830|P3|Participant Flow|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
877055|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
877056|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
877057|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
877058|NCT01155830|O3|Outcome|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
877059|NCT01155830|O2|Outcome|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
877060|NCT01155830|O1|Outcome|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
877061|NCT01155830|E3|Reported Event|Infants Treated With ECMO|Infants suffering cardiopulmonary failure significant enough to require heart/lung bypass treatment with extracorporeal membrane oxygenation (ECMO)
877062|NCT01155830|E2|Reported Event|Infants With Sepsis|Infants who are culture positive for sepsis and require vasopressor support
877063|NCT01155830|E1|Reported Event|Infants With CHD|Infants with Congenital Diaphragmatic Hernia (CHD)
877064|NCT01155726|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed participants.
877065|NCT01155726|P4|Participant Flow|Etafilcon A, Masked, Partially Masked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
877066|NCT01155726|P3|Participant Flow|Etafilcon A, Masked, Unmasked|Etafilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
877067|NCT01155726|P2|Participant Flow|Nelfilcon A, Masked, Partially Masked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, partially masked) in Period 2.
877068|NCT01155726|P1|Participant Flow|Nelfilcon A, Masked, Unmasked|Nelfilcon A in adaptation phase. 1DAVM and DACP (contralateral wear, masked) in Period 1. 1DAVM and DACP (contralateral wear, unmasked) in Period 2.
877069|NCT01155726|O16|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877070|NCT01155726|O15|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877071|NCT01155726|O14|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877072|NCT01155726|O13|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Partial (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877073|NCT01155726|O12|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877074|NCT01155726|O11|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877075|NCT01155726|O10|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877076|NCT01155726|O9|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Partial|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 partial masked. Contralateral wear reported by product/eye.
877077|NCT01155726|O8|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877078|NCT01155726|O7|Outcome|Etafilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877079|NCT01155726|O6|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (DACP)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877080|NCT01155726|O5|Outcome|Nelfilcon A, Pd 1 Masked, Pd 2 Unmasked (1DAVM)|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877081|NCT01155726|O4|Outcome|Etafilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877082|NCT01155726|O3|Outcome|Etafilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Etafilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877083|NCT01155726|O2|Outcome|Nelfilcon A, Pd 1 Masked (DACP), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877084|NCT01155726|O1|Outcome|Nelfilcon A, Pd 1 Masked (1DAVM), Pd 2 Unmasked|Nelfilcon A (adaptation phase), followed by Period 1 masked, Period 2 unmasked. Contralateral wear reported by product/eye.
877085|NCT01155726|E4|Reported Event|DACP|Nelfilcon A with comfort additive contact lenses
877086|NCT01155726|E3|Reported Event|1DAVM|Etafilcon A with comfort additive contact lenses
877087|NCT01155726|E2|Reported Event|Etafilcon A|Etafilcon A contact lenses
877088|NCT01155726|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lenses
877089|NCT01155570|B1|Baseline|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877090|NCT01155570|P1|Participant Flow|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877091|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877092|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877093|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877094|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877096|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877097|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877098|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877099|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877100|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877101|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877102|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877103|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
877104|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877105|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
877106|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877107|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
877108|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877109|NCT01155570|O2|Outcome|Humira (Adalimumab-naive Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg. Excludes participants previously enrolled in study NCT00647400 (M04-072).
877110|NCT01155570|O1|Outcome|Humira (All Participants)|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877111|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877112|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877113|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877114|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877115|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877116|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877117|NCT01155570|O1|Outcome|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877118|NCT01155570|E1|Reported Event|Humira|Humira 40 mg (marketed product) every other week (eow) for subcutaneous injection after initial dosage of 80 mg.
877119|NCT01155531|B5|Baseline|Total|Total of all reporting groups
877120|NCT01155531|B4|Baseline|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877121|NCT01155531|B3|Baseline|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877122|NCT01155531|B2|Baseline|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877123|NCT01155531|B1|Baseline|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877124|NCT01155531|P4|Participant Flow|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877125|NCT01155531|P3|Participant Flow|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877126|NCT01155531|P2|Participant Flow|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877127|NCT01155531|P1|Participant Flow|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877128|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877129|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877130|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877131|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877132|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877133|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
892145|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
877134|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877135|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877136|NCT01155531|O4|Outcome|Sertraline Plus Telenzepine - Group D|received Sertraline 150 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877137|NCT01155531|O3|Outcome|Sertraline Plus Telenzepine - Group C|received Sertraline 100 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877138|NCT01155531|O2|Outcome|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877139|NCT01155531|O1|Outcome|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877140|NCT01155531|E4|Reported Event|Telenzepine Plus Sertraline - Group D|received Sertraline 150 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877141|NCT01155531|E3|Reported Event|Telenzepine Plus Sertraline - Group C|received Sertraline 100 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877142|NCT01155531|E2|Reported Event|Telenzepine Plus Sertraline - Group B|received Sertraline 50 mg/day for 7 days. After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877143|NCT01155531|E1|Reported Event|Telenzepine - Group A|received Sertraline 0 mg/day for 7 days.After 7 days, received telenzepine for 21 days total at 1, 2, and 3 mg/day for 7 days each.
877144|NCT01155479|B6|Baseline|Total|Total of all reporting groups
877145|NCT01155479|B5|Baseline|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877146|NCT01155479|B4|Baseline|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
877147|NCT01155479|B3|Baseline|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877148|NCT01155479|B2|Baseline|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877149|NCT01155479|B1|Baseline|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877150|NCT01155479|P5|Participant Flow|Rasagiline|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877151|NCT01155479|P4|Participant Flow|Placebo|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1); preladenant 5 mg was taken twice daily for 26 weeks (Part 2).
877152|NCT01155479|P3|Participant Flow|Preladenant 10 mg|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877153|NCT01155479|P2|Participant Flow|Preladenant 5 mg|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877154|NCT01155479|P1|Participant Flow|Preladenant 2 mg|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877155|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
877156|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877157|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
877158|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877159|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
877160|NCT01155479|O5|Outcome|Rasagiline (Part 2)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
877161|NCT01155479|O4|Outcome|Placebo (Part 2)|Participants who had received placebo to preladenant in Part 1 received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877162|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 2)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
877163|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 2)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877164|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 2)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
877165|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
877166|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
892146|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
877167|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
877168|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877169|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
877170|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
877171|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
877172|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
877173|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877174|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
877175|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1) and then for another 26 weeks (Part 2).
877176|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
877177|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
877178|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877179|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
877180|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
877181|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
877182|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks. The number of participants analyzed (200) represents the number of randomized and treated participants with at least one post-treatment value.
877183|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks. The number of participants analyzed (202) represents the number of randomized and treated participants with at least one post-treatment value.
877184|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks. The number of participants analyzed (195) represents the number of randomized and treated participants with at least one post-treatment value.
877185|NCT01155479|O5|Outcome|Rasagiline (Part 1)|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks.
877186|NCT01155479|O4|Outcome|Placebo (Part 1)|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks.
877187|NCT01155479|O3|Outcome|Preladenant 10 mg (Part 1)|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks.
877188|NCT01155479|O2|Outcome|Preladenant 5 mg (Part 1)|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks.
877189|NCT01155479|O1|Outcome|Preladenant 2 mg (Part 1)|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks.
877190|NCT01155479|E10|Reported Event|Rasagiline - Part 2|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 2).
877191|NCT01155479|E9|Reported Event|Placebo/Preladenant 5 Mg-Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg oral tablet in the PM for 26 weeks (Part 2).
877192|NCT01155479|E8|Reported Event|Preladenant 10 mg - Part 2|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 2).
877193|NCT01155479|E7|Reported Event|Preladenant 5 mg - Part 2|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 2).
877194|NCT01155479|E6|Reported Event|Preladenant 2 mg - Part 2|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 2).
877195|NCT01155479|E5|Reported Event|Rasagiline - Part 1|Participants received rasagiline 1 mg oral capsule and placebo for preladenant in the AM followed by placebo for preladenant in PM for 26 weeks (Part 1).
877196|NCT01155479|E4|Reported Event|Placebo - Part 1|Participants received placebo for preladenant and placebo for rasagiline in the AM followed by placebo for preladenant in the PM for 26 weeks (Part 1).
877197|NCT01155479|E3|Reported Event|Preladenant 10 mg - Part 1|Participants received preladenant 10 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 10 mg in the PM for 26 weeks (Part 1).
892147|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
877198|NCT01155479|E2|Reported Event|Preladenant 5 mg - Part 1|Participants received preladenant 5 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 5 mg in the PM for 26 weeks (Part 1).
877199|NCT01155479|E1|Reported Event|Preladenant 2 mg - Part 1|Participants received preladenant 2 mg oral tablet and placebo for rasagiline in the AM followed by preladenant 2 mg oral tablet in PM for 26 weeks (Part 1).
877200|NCT01155466|B6|Baseline|Total|Total of all reporting groups
877201|NCT01155466|B5|Baseline|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877202|NCT01155466|B4|Baseline|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877203|NCT01155466|B3|Baseline|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877204|NCT01155466|B2|Baseline|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877205|NCT01155466|B1|Baseline|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877206|NCT01155466|P5|Participant Flow|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877207|NCT01155466|P4|Participant Flow|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877208|NCT01155466|P3|Participant Flow|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877209|NCT01155466|P2|Participant Flow|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877210|NCT01155466|P1|Participant Flow|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877211|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877212|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877213|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877214|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877215|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877216|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877217|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877218|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877219|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877220|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877221|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877222|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877223|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877224|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877225|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877226|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877227|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877228|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877229|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877230|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877231|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877232|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877233|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877234|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877235|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877236|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877237|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877238|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877239|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877240|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877241|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877242|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877243|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877244|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877245|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877246|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877247|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877248|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877249|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877250|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877251|NCT01155466|O5|Outcome|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877252|NCT01155466|O4|Outcome|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877253|NCT01155466|O3|Outcome|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877254|NCT01155466|O2|Outcome|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877255|NCT01155466|O1|Outcome|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877256|NCT01155466|E5|Reported Event|Rasagiline 1 mg|Rasagiline 1 mg capsule + placebo to preladenant tablet in AM and placebo to preladenant tablet in PM for 12 weeks
877257|NCT01155466|E4|Reported Event|Placebo|Placebo to preladenant tablet + placebo to rasagiline capsule in AM and placebo to preladenant tablet in PM for 12 weeks
877258|NCT01155466|E3|Reported Event|Preladenant 10 mg|Preladenant 10 mg tablet + placebo to rasagiline capsule in AM and preladenant 10 mg tablet in PM for 12 weeks
877259|NCT01155466|E2|Reported Event|Preladenant 5 mg|Preladenant 5 mg tablet + placebo to rasagiline capsule in AM and preladenant 5 mg tablet in PM for 12 weeks
877260|NCT01155466|E1|Reported Event|Preladenant 2 mg|Preladenant 2 mg tablet + placebo to rasagiline capsule in AM and preladenant 2 mg tablet in PM for 12 weeks
877261|NCT01155336|B3|Baseline|Total|Total of all reporting groups
877262|NCT01155336|B2|Baseline|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
877263|NCT01155336|B1|Baseline|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
877264|NCT01155336|P2|Participant Flow|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
877265|NCT01155336|P1|Participant Flow|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
877266|NCT01155336|O2|Outcome|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
877267|NCT01155336|O1|Outcome|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
877268|NCT01155336|E2|Reported Event|Lovaza®|"Lovaza® is a prescription grade EPA+DHA fish oil supplement. Four capsules (each containing 1 gram of fish oil) were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~Lovaza® : Lovaza® is prescription grade EPA+DHA fish oil supplement."
877269|NCT01155336|E1|Reported Event|Corn Oil|"The placebo contained 1 gram of corn oil in each capsule. Four capsules were taken within hours after the PCI, daily for the duration of hospitalization, and daily for 1 week until a post-discharge follow-up appointment.~The placebo contained 1 gram of corn oil in each capsule. : Placebo Pill"
877270|NCT01155323|B1|Baseline|Total Number of Participants|This represents all subjects that completed the study minus one additional subject excluded due the discovery after study completion that the subject conflicted with exclusion criteria.
877271|NCT01155323|P2|Participant Flow|Omafilcon A/Etafilcon A|omafilcon A contact lenses will be worn first and etafilcon A contact lenses will be worn second.
877272|NCT01155323|P1|Participant Flow|Etafilcon A/Omafilcon A|etafilcon A contact lenses will be worn first and omafilcon A contact lenses will be worn second.
877273|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
877274|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
877275|NCT01155323|O2|Outcome|Omafilcon A|soft contact lens replaced daily, worn for one week.
877276|NCT01155323|O1|Outcome|Etafilcon A|soft contact lens replaced daily, worn for one week.
877288|NCT01155219|B2|Baseline|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
877289|NCT01155219|B1|Baseline|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
877290|NCT01155219|P2|Participant Flow|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
877291|NCT01155219|P1|Participant Flow|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
877292|NCT01155219|O2|Outcome|Xalatan®|"Xalatan® (Latanaprost) aqueous eye drop (one drop in the conjunctival sac of each eye in the evening during 84 days.~Xalatan: one drop in the conjunctival sac of each eye in the morning (84 days)."
877293|NCT01155219|O1|Outcome|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % timolol maleate, without preservative) packaged in single-dose containers (unidoses); one drop in the conjunctival sac of each eye in the morning (84 days).~Geltim LP 1 mg/g: one drop in the conjunctival sac of each eye in the morning (84 days)."
877294|NCT01155219|E2|Reported Event|Xalatan®|"Latanoprost~One drop in the conjunctival sac of each eye in the evening"
877295|NCT01155219|E1|Reported Event|Geltim LP®|"Geltim LP® 1 mg/g (0.1 % unpreserved timolol maleate gel)~One drop in the conjunctival sac of each eye in the morning"
877296|NCT01155180|B3|Baseline|Total|Total of all reporting groups
877297|NCT01155180|B2|Baseline|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo-daily self injections for 6 months"
877298|NCT01155180|B1|Baseline|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
877299|NCT01155180|P2|Participant Flow|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
877300|NCT01155180|P1|Participant Flow|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
877301|NCT01155180|O2|Outcome|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
877302|NCT01155180|O1|Outcome|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
877303|NCT01155180|E2|Reported Event|Placebo|"We will start the placebo at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Placebo: Placebo"
877304|NCT01155180|E1|Reported Event|Leptin|"We will start the leptin at a dose of 0.08mg/kg fat mass in men and 0.14mg/kg fat mass in women~Leptin: Hormone - daily self injections for 6 months"
877305|NCT01155167|B3|Baseline|Total|Total of all reporting groups
877306|NCT01155167|B2|Baseline|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877307|NCT01155167|B1|Baseline|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877308|NCT01155167|P2|Participant Flow|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877309|NCT01155167|P1|Participant Flow|Placebo|Two placebo topical lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877310|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877311|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877312|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877313|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877314|NCT01155167|O2|Outcome|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877315|NCT01155167|O1|Outcome|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877316|NCT01155167|E2|Reported Event|Topical Dilator|40mg of lidocaine cream + 30mg nitroglycerin ointment were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877317|NCT01155167|E1|Reported Event|Placebo|Two topical placebo lotions (chosen to resemble the appearance of the active creams) were applied to the radial artery site and covered by transparent film dressing for at least 30 minutes prior to the radial artery access time.
877318|NCT01155154|B4|Baseline|Total|Total of all reporting groups
877319|NCT01155154|B3|Baseline|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
877320|NCT01155154|B2|Baseline|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
877321|NCT01155154|B1|Baseline|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
877323|NCT01155154|P2|Participant Flow|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
877324|NCT01155154|P1|Participant Flow|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
877325|NCT01155154|O3|Outcome|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
877326|NCT01155154|O2|Outcome|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
877327|NCT01155154|O1|Outcome|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
877328|NCT01155154|E3|Reported Event|Placebo|placebo: Two placebo capsules every 6 hours for 7 days
877329|NCT01155154|E2|Reported Event|Cepahlexin|cephalexin: 500 mg (two 250 mg capsules) every 6 hours for 7 days
877330|NCT01155154|E1|Reported Event|Clindamycin|"clindamycin 300 mg (two 150 mg capsules) every 6 hours for 7 days~clindamycin: 300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days"
877331|NCT01155141|B1|Baseline|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877332|NCT01155141|P1|Participant Flow|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877333|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877334|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877335|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877336|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877337|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877338|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877339|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877340|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877341|NCT01155141|O1|Outcome|H.P. Acthar Gel|Patients treated with 40 units subcutaneously (SC) weekly for 2 weeks, 80 units SC weekly for 2 weeks, then 80 units SC twice weekly to complete 16 weeks of therapy.
877342|NCT01155141|E1|Reported Event|H.P. Acthar Gel|Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
877343|NCT01155063|B1|Baseline|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877344|NCT01155063|P1|Participant Flow|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877345|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877346|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877347|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877348|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877349|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877350|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877351|NCT01155063|O1|Outcome|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877352|NCT01155063|E1|Reported Event|Exemestane|Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy.
877353|NCT01155024|B1|Baseline|Entire Study Population|Includes groups randomized to receive the traditional diagnostic prosthetic socket first and the direct manufactured prosthetic socket first
877354|NCT01155024|P2|Participant Flow|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
877355|NCT01155024|P1|Participant Flow|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
877356|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
877357|NCT01155024|O1|Outcome|Socket Preference|Participant's indicated preference of socket type (preferred traditional socket, preferred direct manufactured socket, or no preference/difference)
877358|NCT01155024|O2|Outcome|Direct Manufactured Socket|Direct manufactured prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
877359|NCT01155024|O1|Outcome|Traditional Socket|Traditional diagnostic prosthetic socket fitted using typical fitting techniques in either the first intervention period or second intervention period.
877360|NCT01155024|E2|Reported Event|Direct Manufactured Socket|Initial fitting of a direct manufactured prosthetic socket
877361|NCT01155024|E1|Reported Event|Traditional Socket|Initial fitting of a traditional diagnostic prosthetic socket
877362|NCT01154985|B4|Baseline|Total|Total of all reporting groups
877363|NCT01154985|B3|Baseline|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
877364|NCT01154985|B2|Baseline|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
877365|NCT01154985|B1|Baseline|Placebo|Placebo: Placebo three times a day (TID) for 365 days
877366|NCT01154985|P3|Participant Flow|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
877367|NCT01154985|P2|Participant Flow|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
877368|NCT01154985|P1|Participant Flow|Placebo|Placebo: Placebo three times a day (TID) for 365 days
877369|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
877370|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
877371|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
877372|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
877373|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
877374|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
877375|NCT01154985|O3|Outcome|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
877376|NCT01154985|O2|Outcome|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
877377|NCT01154985|O1|Outcome|Placebo|Placebo: Placebo three times a day (TID) for 365 days
877378|NCT01154985|E3|Reported Event|EPA-E 2700 mg/Day|EPA-E: 900 mg TID for 365 days
877379|NCT01154985|E2|Reported Event|EPA-E 1800 mg/Day|EPA-E: 600 mg TID for 365 days
877380|NCT01154985|E1|Reported Event|Placebo|Placebo: Placebo three times a day (TID) for 365 days
877381|NCT01154816|B13|Baseline|Total|Total of all reporting groups
877382|NCT01154816|B12|Baseline|Rhaboid Malignancy|Experimental: Arm 12
877383|NCT01154816|B11|Baseline|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
877384|NCT01154816|B10|Baseline|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
877385|NCT01154816|B9|Baseline|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
877386|NCT01154816|B8|Baseline|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
877387|NCT01154816|B7|Baseline|Childhood Hepatoblastoma|Experimental: Arm 7
877388|NCT01154816|B6|Baseline|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
877389|NCT01154816|B5|Baseline|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
877390|NCT01154816|B4|Baseline|Recurrent Osteosarcoma|Experimental: Arm 4
877391|NCT01154816|B3|Baseline|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
877392|NCT01154816|B2|Baseline|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
877393|NCT01154816|B1|Baseline|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
877394|NCT01154816|P12|Participant Flow|Rhaboid Malignancy|Experimental: Arm 12
877395|NCT01154816|P11|Participant Flow|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
877396|NCT01154816|P10|Participant Flow|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
877397|NCT01154816|P9|Participant Flow|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
877398|NCT01154816|P8|Participant Flow|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
877399|NCT01154816|P7|Participant Flow|Childhood Hepatoblastoma|Experimental: Arm 7
877400|NCT01154816|P6|Participant Flow|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
877401|NCT01154816|P5|Participant Flow|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
877402|NCT01154816|P4|Participant Flow|Recurrent Osteosarcoma|Experimental: Arm 4
877403|NCT01154816|P3|Participant Flow|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
877404|NCT01154816|P2|Participant Flow|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
877405|NCT01154816|P1|Participant Flow|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
877406|NCT01154816|O1|Outcome|All Patients|All patients.
877407|NCT01154816|O1|Outcome|All Patients|All patients.
877408|NCT01154816|O1|Outcome|All Patients|All patients.
877409|NCT01154816|O1|Outcome|All Patients|All patients.
877410|NCT01154816|O1|Outcome|All Patients|All patients.
877411|NCT01154816|O1|Outcome|All Patients|All patients.
877412|NCT01154816|O1|Outcome|All Patients|All patients
877413|NCT01154816|O12|Outcome|Rhaboid Malignancy|Experimental: Arm 12
877414|NCT01154816|O11|Outcome|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
877415|NCT01154816|O10|Outcome|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
877416|NCT01154816|O9|Outcome|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
877417|NCT01154816|O8|Outcome|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
877418|NCT01154816|O7|Outcome|Childhood Hepatoblastoma|Experimental: Arm 7
877419|NCT01154816|O6|Outcome|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
877420|NCT01154816|O5|Outcome|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
877421|NCT01154816|O4|Outcome|Recurrent Osteosarcoma|Experimental: Arm 4
877422|NCT01154816|O3|Outcome|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
877423|NCT01154816|O2|Outcome|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
877424|NCT01154816|O1|Outcome|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
877425|NCT01154816|E12|Reported Event|Rhaboid Malignancy|Experimental: 12
877426|NCT01154816|E11|Reported Event|Recurrent Childhood Acute Myeloid Leukemia|Experimental: Arm 11
877427|NCT01154816|E10|Reported Event|Recurrent Childhood Acute Lympohblastic Leukemia|Experimental: Arm 10
877428|NCT01154816|E9|Reported Event|Recurrent Wilms Tumor and Other Childhood Kidney Tumors|Experimental: Arm 9
877429|NCT01154816|E8|Reported Event|Recurrent Childhood Germ Cell Tumor|Experimental: Arm 8
877430|NCT01154816|E7|Reported Event|Childhood Hepatoblastoma|Experimental: Arm 7
877431|NCT01154816|E6|Reported Event|Recurrent Childhood Soft Tissue Sarcoma|Experimental: Arm 6
877432|NCT01154816|E5|Reported Event|Recurrent Ewing Sarcoma /Peripheral Neuroectodermal Tumor|Experimental: Arm 5
877433|NCT01154816|E4|Reported Event|Recurrent Osteosarcoma|Experimental: Arm 4
877434|NCT01154816|E3|Reported Event|Previously Treated Childhood Rhabdomyosarcoma|Experimental: Arm 3
877435|NCT01154816|E2|Reported Event|Recurrent Neuroblastoma Only MIBG Evaluable Disease at Enroll|Experimental: Arm 2
877436|NCT01154816|E1|Reported Event|Recurrent Neuroblastoma With Measurable Disease at Enrollment|Experimental: Arm 1
877437|NCT01154699|B3|Baseline|Total|Total of all reporting groups
877438|NCT01154699|B2|Baseline|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
877439|NCT01154699|B1|Baseline|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
877440|NCT01154699|P2|Participant Flow|Bilevel PAP First, Then Usual Care|"Subjects will begin the study by starting on Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests. After a 4 week Washout Period of usual care, they will start a Usual Care period for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period."
877441|NCT01154699|P1|Participant Flow|Usual Care First, Then Bilevel PAP|"Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period. After a Washout Period of an additional 4 weeks of usual care, they will then start Bilevel PAP therapy for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests."
877442|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
877443|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
877444|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
877445|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
877446|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
877447|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
877448|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
877449|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
877450|NCT01154699|O2|Outcome|Bi-level PAP|"Subjects wear Bi-level PAP during the night for 4 weeks, and record asthma quality of life and asthma symptoms.~Bi-level positive airway pressure (bi-level PAP): Subjects will use bi-level PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night."
877451|NCT01154699|O1|Outcome|Usual Care|Subjects record asthma quality of life and symptoms, without intervention for 4 weeks.
877452|NCT01154699|O2|Outcome|Bilevel PAP|Subjects will wear Bilevel PAP for 4 weeks. Just before and after the Bilevel PAP they will complete questionnaires and breathing tests.
877453|NCT01154699|O1|Outcome|Usual Care|Subjects will begin the study by continuing their usual care for 4 weeks. They will complete questionnaires and breathing tests at the start and end of this 4 week period.
877454|NCT01154699|E2|Reported Event|Asthma + OSA|Subjects meeting all inclusion criteria and no exclusion criteria with asthma and obstructive sleep apnea on continuous positive airway pressure (CPAP) treatment
877455|NCT01154699|E1|Reported Event|Asthma Only|Subjects meeting all inclusion criteria and no exclusion criteria with asthma only (no sleep apnea)
877456|NCT01154673|B3|Baseline|Total|Total of all reporting groups
877457|NCT01154673|B2|Baseline|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
877458|NCT01154673|B1|Baseline|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
877459|NCT01154673|P2|Participant Flow|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID) and endpoint is measured at 48 weeks
877460|NCT01154673|P1|Participant Flow|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID and endpoint is measured at 48 weeks"
877461|NCT01154673|O2|Outcome|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
877462|NCT01154673|O1|Outcome|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
877463|NCT01154673|E2|Reported Event|Placebo Arm|Placebo (in place of raltegravir and maraviroc) will be added to standard HAART (Emtricitabine 200mg /tenofovir 300mg QD + Lopinavir 400 mg/ritonavir 100mg BID)
877464|NCT01154673|E1|Reported Event|Intensive HAART|"Patients in this arm will receive the following HAART regimen:~Raltegravir 400 mg BID + Maraviroc 150mg BID + emtricitabine 200mg /tenofovir 300mg QD + lopinavir 400 mg/ritonavir 100mg BID"
877465|NCT01154634|B5|Baseline|Total|Total of all reporting groups
877466|NCT01154634|B4|Baseline|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877467|NCT01154634|B3|Baseline|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877468|NCT01154634|B2|Baseline|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877469|NCT01154634|B1|Baseline|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877470|NCT01154634|P4|Participant Flow|First Placebo, Then 40 mg, Then 5 mg, Then 16 mg|period 1: placebo, period 2: washout, period 3: AZD2516 40 mg, period 4: washout, period 5: AZD2516 5 mg, period 6: washout, period 7: AZD2516 16 mg
877471|NCT01154634|P3|Participant Flow|First 16 mg, Then 5 mg, Then 40 mg, Then Placebo|period 1: AZD2516 16 mg, period 2: washout, period 3: AZD2516 5 mg, period 4: washout, period 5: AZD2516 40 mg, period 6: washout, period 7: placebo.
877472|NCT01154634|P2|Participant Flow|First 40 mg, Then 16 mg, Then Placebo, Then 5 mg|period 1: AZD2516 40 mg, period 2: washout, period 3: AZD2516 16 mg, period 4: washout, period 5: placebo, period 6: washout, period 7: AZD2516 5 mg.
877473|NCT01154634|P1|Participant Flow|First 5 mg, Then Placebo, Then 16 mg, Then 40 mg|period 1: AZD2516 5 mg, period 2: washout, period 3: placebo, period 4: washout, period 5: AZD2516 16 mg, period 6: washout, period 7: AZD2516 40 mg.
877474|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877475|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877476|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877477|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877478|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877479|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877480|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877481|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877482|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877483|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877484|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877485|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877486|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877487|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877488|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877489|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877490|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877491|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877492|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877493|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877494|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877495|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877496|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877497|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877498|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
878080|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
877499|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877500|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877501|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877502|NCT01154634|O4|Outcome|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877503|NCT01154634|O3|Outcome|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877504|NCT01154634|O2|Outcome|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877505|NCT01154634|O1|Outcome|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877506|NCT01154634|E4|Reported Event|Placebo|Loading dose: 3 * placebo capsules. Maintenance dose: 3 * placebo capsules and 3 * placebo capsules.
877507|NCT01154634|E3|Reported Event|AZD2516 40 mg|Loading dose: 2 * AZD2616 10 mg capsules, 1 * placebo capsule. Maintenance dose: 2 * AZD2616 5 mg capsules, 1 * placebo capsule and 2 * AZD2616 5 mg capsules, 1 * placebo capsule.
877508|NCT01154634|E2|Reported Event|AZD2516 16 mg|Loading dose: 2 * AZD2516 5mg capsule, 1 * placebo capsule. Maintenance dose: 3 * AZD2516 1 mg capsule and 3 * AZD2516 1 mg capsule.
877509|NCT01154634|E1|Reported Event|AZD2516 5 mg|Loading dose: 3 * AZD2516 1 mg capsules. Maintenance doses: 1 * AZD2516 1 mg capsule, 2 * placebo capsules and 1 * AZD2516 1 mg capsule, 2 * placebo capsules.
877510|NCT01154452|B5|Baseline|Total|Total of all reporting groups
877511|NCT01154452|B4|Baseline|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
877512|NCT01154452|B3|Baseline|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
877513|NCT01154452|B2|Baseline|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
877514|NCT01154452|B1|Baseline|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
877515|NCT01154452|P4|Participant Flow|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
877516|NCT01154452|P3|Participant Flow|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
877517|NCT01154452|P2|Participant Flow|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
877518|NCT01154452|P1|Participant Flow|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
877519|NCT01154452|O4|Outcome|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
877520|NCT01154452|O3|Outcome|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
877521|NCT01154452|O2|Outcome|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
877522|NCT01154452|O1|Outcome|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
877523|NCT01154452|O1|Outcome|All Phase Ib Participants|All Phase Ib Participants
877524|NCT01154452|E4|Reported Event|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD|ARM 2: GDC-0449 150 mg PO QD and RO4929097 15 mg PO QD
877525|NCT01154452|E3|Reported Event|ARM 1 - RO4929097: 15 mg PO QD|ARM 1 - RO4929097: 15 mg PO QD
877526|NCT01154452|E2|Reported Event|RO4929097 15 mg|RO4929097: 15 mg PO QD, GDC-0449: 150 mg PO QD
877527|NCT01154452|E1|Reported Event|RO4929097 10mg|RO4929097: 10mg PO QD, GDC-0449: 150 mg PO QD
877528|NCT01154335|B4|Baseline|Total|Total of all reporting groups
877529|NCT01154335|B3|Baseline|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
877530|NCT01154335|B2|Baseline|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
877531|NCT01154335|B1|Baseline|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
877532|NCT01154335|P3|Participant Flow|Dose Level 2a|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
877533|NCT01154335|P2|Participant Flow|Dose Level 2|"combination of OSI-906 and everolimus~OSI-906: 100 mg Twice a Day, cycle-28 days~Everolimus: 10mg Daily, cycle-28 days"
877534|NCT01154335|P1|Participant Flow|Dose Level 1|"combination of OSI-906 and everolimus~OSI-906: 50 mg Twice a Day, cycle-28 days~Everolimus: 5mg Daily, cycle-28 days"
877535|NCT01154335|O1|Outcome|All Patients|Response Rate was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
877536|NCT01154335|O1|Outcome|All Patients|Overall Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
877537|NCT01154335|O1|Outcome|All Patients|Progression-Free Survival was determined only as a preliminary indication of efficacy and was calculated for all patients at all dose levels
877538|NCT01154335|O1|Outcome|All Patients|Determination of the MTD consists of the selection of one of the three dose levels as the maximum tolerated dose. This outcome is the same for all patients.
877539|NCT01154335|E1|Reported Event|All Patients|Adverse Event data was was calculated for all patients at all dose levels
877540|NCT01154322|B1|Baseline|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
877541|NCT01154322|P1|Participant Flow|Pediatric Mask|Pixi pediatric mask : The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
877542|NCT01154322|O1|Outcome|Pixi Mask|AHI with Pixi mask
877543|NCT01154322|O1|Outcome|Currently-used Mask|Baseline AHI prior to Pixi mask use
877544|NCT01154322|E1|Reported Event|Overall Study|
877546|NCT01154296|B2|Baseline|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877547|NCT01154296|B1|Baseline|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877548|NCT01154296|P2|Participant Flow|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877549|NCT01154296|P1|Participant Flow|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877550|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877551|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877552|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877553|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877554|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877555|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877556|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877557|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877603|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877558|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877559|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877560|NCT01154296|O2|Outcome|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877561|NCT01154296|O1|Outcome|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877562|NCT01154296|E2|Reported Event|Rapid HIV Testing & Information Only (Group 2)|Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 2 will receive rapid HIV testing with information only.
877563|NCT01154296|E1|Reported Event|Rapid HIV Testing w/ Counseling (Group 1)|"Individuals who screen as eligible will complete written informed consent procedures, be enrolled, be tested for STIs, and be asked to complete a baseline assessment using audio computer-assisted self interview (ACASI). Then participants randomized to group 1 will receive rapid HIV testing and RESPECT-2 counseling.~RESPECT-2 Counseling: Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results."
877564|NCT01154283|B3|Baseline|Total|Total of all reporting groups
877565|NCT01154283|B2|Baseline|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
877566|NCT01154283|B1|Baseline|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
877567|NCT01154283|P2|Participant Flow|IPAP-only, NIPPV Then Bi-level, Standard NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure then Standard NIPPV with both an inspiratory and expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
877568|NCT01154283|P1|Participant Flow|Bi-level, Standard, NIPPV Then IPAP-only NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure then NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
877569|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877570|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877571|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877572|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877573|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877574|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877575|NCT01154283|O2|Outcome|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure, no expiratory positive airway pressure~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877576|NCT01154283|O1|Outcome|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation"
877577|NCT01154283|E2|Reported Event|IPAP-only, NIPPV|"NIPPV with only inspiratory positive airway pressure (IPAP-only), no expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
877578|NCT01154283|E1|Reported Event|Bi-level, Standard, NIPPV|"Standard NIPPV with both an inspiratory and expiratory positive airway pressure.~Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine): Noninvasive positive airway pressure ventilation (NIPPV)"
877579|NCT01154231|B1|Baseline|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
877580|NCT01154231|P1|Participant Flow|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
877581|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
877582|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
877583|NCT01154231|O1|Outcome|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
877584|NCT01154231|E1|Reported Event|BeneFIX (Nonacog Alfa)|Participants, who received BeneFIX injection intravenously as indicated in the approved local product document, were observed for periods of 1 year for PTPs and 2 years for PUPs. The dosage can be adjusted as per physician’s discretion.
877585|NCT01154218|B1|Baseline|Entire Study Population|Includes participants randomized to receive any treatment (crizotinib 250 mg IRT fasted first, crizotinib 250 mg PIC fasted first, crizotinib 250 mg CIC fasted first and crizotinib 250 mg CIC fed).
877586|NCT01154218|P4|Participant Flow|Crizotinib 250 mg CIC Fed, CIC Fasted, PIC Fasted, IRT Fasted|Single oral dose of crizotinib 250 mg CIC in fed state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg PIC in fasted state in third intervention period; and single oral dose of crizotinib 250 mg IRT in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
877587|NCT01154218|P3|Participant Flow|Crizotinib 250 mg CIC Fasted, IRT Fasted, CIC Fed, PIC Fasted|Single oral dose of crizotinib 250 mg CIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in third intervention period; and single oral dose of crizotinib 250 mg PIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
877588|NCT01154218|P2|Participant Flow|Crizotinib 250 mg PIC Fasted, CIC Fed, IRT Fasted, CIC Fasted|Single oral dose of crizotinib 250 mg PIC in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg CIC in fed state in second intervention period; followed by single oral dose of crizotinib 250 mg IRT in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fasted state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
877589|NCT01154218|P1|Participant Flow|Crizotinib 250 mg IRT Fasted, PIC Fasted, CIC Fasted, CIC Fed|Single oral dose of crizotinib 250 milligram (mg) immediate release tablet (IRT) in fasted state in first intervention period; followed by single oral dose of crizotinib 250 mg powder in capsule (PIC) in fasted state in second intervention period; followed by single oral dose of crizotinib 250 mg commercial image capsule (CIC) in fasted state in third intervention period; and single oral dose of crizotinib 250 mg CIC in fed state in fourth intervention period. A washout period of at least 14 days was maintained between each period.
877590|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877591|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877592|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877593|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877594|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877595|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877596|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877597|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877598|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877599|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877600|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877601|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877602|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
878081|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
877604|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877605|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877606|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877607|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877608|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877609|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877610|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877611|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877612|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877613|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877614|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877615|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877616|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877617|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877618|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877619|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877620|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877621|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877622|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877623|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877624|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877625|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877626|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877627|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877628|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877629|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877630|NCT01154218|O4|Outcome|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877631|NCT01154218|O3|Outcome|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877632|NCT01154218|O2|Outcome|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877633|NCT01154218|O1|Outcome|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877634|NCT01154218|E4|Reported Event|Crizotinib CIC Fed|Single oral dose of crizotinib 250 mg CIC (Treatment D [Test High Fat]) in fed state in any intervention period.
877635|NCT01154218|E3|Reported Event|Crizotinib CIC Fasted|Single oral dose of crizotinib 250 mg CIC (Treatment C [Test for bioequivalence (BE), Reference for Food effect]) in fasted state in any intervention period.
877636|NCT01154218|E2|Reported Event|Crizotinib PIC Fasted|Single oral dose of crizotinib 250 mg PIC (Treatment B [Reference 2]) in fasted state in any intervention period.
877637|NCT01154218|E1|Reported Event|Crizotinib IRT Fasted|Single oral dose of crizotinib 250 mg IRT (Treatment A [Reference 1]) in fasted state in any intervention period.
877638|NCT01154166|B3|Baseline|Total|Total of all reporting groups
877639|NCT01154166|B2|Baseline|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
878082|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
892148|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
877640|NCT01154166|B1|Baseline|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877641|NCT01154166|P2|Participant Flow|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877642|NCT01154166|P1|Participant Flow|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877643|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877644|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877645|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877646|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877647|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877648|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877649|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877781|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877650|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877651|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877652|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877653|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877654|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877655|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877656|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877657|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877658|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877659|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877782|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877783|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877660|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877661|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877662|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877663|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877664|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877665|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877666|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877667|NCT01154166|O2|Outcome|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877668|NCT01154166|O1|Outcome|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877669|NCT01154166|E2|Reported Event|Ropinirole PR|Participants initially received Ro-PR 2 mg tablets OD in the 24-week TP. The Ro-PR dose was up-titrated weekly by 2 mg for the first 3 weeks of treatment. Later, the daily dose was increased by 4 mg every 2 weeks, up to a maximum dose of 24 mg per day. The L-dopa dose was reduced after a dose of 8 mg or 12 mg of study medication had been achieved. Participants who did not experience symptom improvement after up-titration of Ro-PR by 2 dose levels were allowed to take L-dopa (maximum up to their baseline dose). After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of Ro-PR.
877784|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
892149|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
877670|NCT01154166|E1|Reported Event|Placebo|"Participants received placebo tablets identical to ropinirole prolonged release (Ro-PR) tablets once daily (OD) in the 24-week Treatment Phase (TP). The L-dopa dose was reduced after a dose of 8 milligrams (mg) or 12 mg of study medication had been achieved. If a loss of symptom control occurred and persisted after study medication had been up-titrated once, participants were to be rescued with open-label L-dopa, which was not to exceed the dose being taken at baseline. After the 24-week TP, all participants were down-titrated over a 7-day period. Those participants who did not enter the extension study returned for a follow-up visit 4 to 14 days after the last dose of medication."
877671|NCT01154153|B3|Baseline|Total|Total of all reporting groups
877672|NCT01154153|B2|Baseline|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877673|NCT01154153|B1|Baseline|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877674|NCT01154153|P2|Participant Flow|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877675|NCT01154153|P1|Participant Flow|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877676|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877677|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877678|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877679|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877680|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877681|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877682|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877683|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877684|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877685|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877686|NCT01154153|O2|Outcome|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877687|NCT01154153|O1|Outcome|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877688|NCT01154153|E2|Reported Event|TAA-AQ|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and TAA-AQ (Nasacort AQ) during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877689|NCT01154153|E1|Reported Event|Placebo|Children >=2 to <12 years old with AR symptoms who received placebo during the screening phase and placebo during the treatment phase. All children had the option to take rescue medication, (Claritin®) as needed to relieve symptoms of AR.
877690|NCT01154140|B3|Baseline|Total|Total of all reporting groups
877691|NCT01154140|B2|Baseline|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877692|NCT01154140|B1|Baseline|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877785|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877693|NCT01154140|P2|Participant Flow|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877694|NCT01154140|P1|Participant Flow|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877695|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877696|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877697|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877698|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877699|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877700|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877701|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877702|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877703|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877704|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877705|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877706|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
878344|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
877707|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877708|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877709|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877710|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877711|NCT01154140|O3|Outcome|Crizotinib (Cycle 5 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 5 Day 1. Treatment cycle was defined as 3 weeks.
877712|NCT01154140|O2|Outcome|Crizotinib (Cycle 3 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 3 Day 1. Treatment cycle was defined as 3 weeks.
877713|NCT01154140|O1|Outcome|Crizotinib (Cycle 2 Day 1)|Crizotinib capsules, 250 mg BID, were administered orally at Cycle 2 Day 1. Treatment cycle was defined as 3 weeks.
877714|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877715|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877716|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877717|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877718|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877719|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877720|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877721|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877722|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877723|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877724|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877725|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877726|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877727|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877728|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877729|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877730|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877731|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877732|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877733|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877734|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877735|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877736|NCT01154140|O2|Outcome|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
878345|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
877737|NCT01154140|O1|Outcome|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877738|NCT01154140|E2|Reported Event|Chemotherapy|Standard doses of chemotherapy were administered by intravenous (IV) infusion. Pemetrexed (500 mg/m2) was administered over 10 minutes or according to institutional administration timing; cisplatin (75 mg/m2) was administered after adequate hydration beginning approximately 30 minutes after the end of the pemetrexed infusion and carboplatin was administered at a dose calculated to produce an area under the concentration time curve [AUC] of 5 or 6 mg*min/mL, beginning approximately 30 minutes after end of pemetrexed infusion.
877739|NCT01154140|E1|Reported Event|Crizotinib|Crizotinib capsules, 250 mg twice daily (BID), were administered orally at approximately the same time each day on a continuous daily dosing schedule. Each treatment cycle was defined as 3 weeks. Participants could continue crizotinib treatment beyond the time of RECIST defined Progressive Disease (PD), as determined by independent radiology review (IRR), at the discretion of the investigator if the participant was perceived to be experiencing clinical benefit.
877740|NCT01154127|B3|Baseline|Total|Total of all reporting groups
877741|NCT01154127|B2|Baseline|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877742|NCT01154127|B1|Baseline|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877743|NCT01154127|P2|Participant Flow|Placebo Followed by NVA237|"Period 1: Matching placebo of NVA237 via NEOHALER inhaler device for 21 days~Period 2: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877744|NCT01154127|P1|Participant Flow|NVA237 Followed by Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days.~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877745|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877746|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877747|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877748|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877749|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877750|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877751|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877752|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877753|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877754|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877755|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877756|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877757|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877758|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877759|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877760|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877761|NCT01154127|O2|Outcome|Placebo|"Participants received Placebo 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877762|NCT01154127|O1|Outcome|NVA237|"Participants received NVA237 50 μg once daily delivered via the NEOHALER inhaler device device for 3 weeks (21 days).~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877763|NCT01154127|E2|Reported Event|Placebo|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877764|NCT01154127|E1|Reported Event|NVA237|"Period 1: 50 μg NVA237 via NEOHALER inhaler device for 21 days~Period 2: Matching placebo via NEOHALER inhaler device for 21 days~The washout period ran for 14 to 28 days between treatment periods. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study.~Salbutamol (albuterol) was used as rescue medication throughout the study."
877765|NCT01154036|B4|Baseline|Total|Total of all reporting groups
877766|NCT01154036|B3|Baseline|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
877767|NCT01154036|B2|Baseline|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877768|NCT01154036|B1|Baseline|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877769|NCT01154036|P8|Participant Flow|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877770|NCT01154036|P7|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877771|NCT01154036|P6|Participant Flow|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877772|NCT01154036|P5|Participant Flow|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877773|NCT01154036|P4|Participant Flow|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877774|NCT01154036|P3|Participant Flow|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877775|NCT01154036|P2|Participant Flow|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877776|NCT01154036|P1|Participant Flow|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877777|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877778|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877779|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877780|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
878083|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
877786|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877787|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877788|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877789|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877790|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877791|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877792|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877793|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877794|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877795|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877796|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877797|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877798|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877799|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877800|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877801|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877802|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877803|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877804|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877805|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877806|NCT01154036|O3|Outcome|Phase 1: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877807|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877808|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877809|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877810|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877811|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877812|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877813|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877814|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877815|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877816|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877817|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877818|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877819|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877820|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877821|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877822|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877823|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877824|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877825|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877826|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877827|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877828|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877829|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877830|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877831|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877832|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877833|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877834|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877835|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877836|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877837|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877838|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877839|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877840|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877841|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877842|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877843|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877844|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877845|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877846|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877847|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877848|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877849|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877850|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877851|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877852|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877853|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877854|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877855|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877856|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
892150|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
877857|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877858|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877859|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877860|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877861|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877862|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877863|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877864|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877865|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877866|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877867|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877868|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877869|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877870|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877871|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877872|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877873|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877874|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877875|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877876|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877877|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877878|NCT01154036|O3|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877879|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877880|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877881|NCT01154036|O5|Outcome|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877882|NCT01154036|O4|Outcome|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877883|NCT01154036|O3|Outcome|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877884|NCT01154036|O2|Outcome|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877885|NCT01154036|O1|Outcome|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877886|NCT01154036|O3|Outcome|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks;
877887|NCT01154036|O2|Outcome|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877888|NCT01154036|O1|Outcome|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877889|NCT01154036|E8|Reported Event|Phase II: Rosuvastatin 20mg|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase II
877890|NCT01154036|E7|Reported Event|Phase II: EZ 10mg + Atorva 20mg [R]|Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877891|NCT01154036|E6|Reported Event|Phase II: Atorva 40mg|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II
877892|NCT01154036|E5|Reported Event|Phase II: EZ 10mg + Atorva 20mg [A]|Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II
877893|NCT01154036|E4|Reported Event|Phase II: EZ 10mg+Atorva 10mg|Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I.
877894|NCT01154036|E3|Reported Event|Phase I: Rosuvastatin 10 mg|Rosuvastatin 10 mg tablet once daily for 6 weeks
877895|NCT01154036|E2|Reported Event|Phase I: Atorvastatin 20 mg|Atorvastatin 20 mg tablet once daily for 6 weeks
877896|NCT01154036|E1|Reported Event|Phase I: Ezetimibe (EZ) 10 mg + Atorvastatin (Atorva) 10 mg|Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks
877897|NCT01154010|B3|Baseline|Total|Total of all reporting groups
877898|NCT01154010|B2|Baseline|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids."
877899|NCT01154010|B1|Baseline|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids."
877900|NCT01154010|P2|Participant Flow|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
877901|NCT01154010|P1|Participant Flow|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
877902|NCT01154010|O2|Outcome|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
877903|NCT01154010|O1|Outcome|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis in process as of December, 2016."
877904|NCT01154010|E2|Reported Event|Placebo Device|"Patients wear the PEMF placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~PEMF Placebo: Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.~Analysis on-going as of December, 2016."
877905|NCT01154010|E1|Reported Event|Active Device|"ActiPatch, a device that emits a low frequency energy called pulsed electromagnetic field (PEMF), will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~PEMF: ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.~Analysis on-going as of December, 2016."
877906|NCT01153984|B1|Baseline|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877907|NCT01153984|P1|Participant Flow|Erlotinib|Participants received 150 milligrams (mg) erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877908|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877909|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877910|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877911|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877912|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877913|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877914|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877915|NCT01153984|O1|Outcome|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877916|NCT01153984|E1|Reported Event|Erlotinib|Participants received 150 mg erlotinib orally daily until disease progression, unacceptable toxicity, withdrawal due to any reason or death.
877958|NCT01153893|B2|Baseline|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
892151|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
877917|NCT01153971|B1|Baseline|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877918|NCT01153971|P1|Participant Flow|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 milligrams per square meter (mg/m^2) intravenously (IV) and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with complete response (CR), unconfirmed complete response (CRu), or partial response (PR), received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877919|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877920|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877921|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877922|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877923|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877924|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877993|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
878084|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
877925|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877926|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877927|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877928|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877929|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877930|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877931|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877932|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877959|NCT01153893|B1|Baseline|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877933|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877934|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877935|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877936|NCT01153971|O1|Outcome|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877937|NCT01153971|E1|Reported Event|Rituximab + Fludarabine + Cyclophosphamide|"Cycle 1 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 1, 2, and 3 and rituximab 375 mg/m^2 IV on Day 8, followed by 20 days of rest.~Cycles 2-3 and Cycle 6 (28-day cycle): Participants received rituximab 375 mg/m^2 IV on Day 1 and fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 followed by 24 days of rest.~Cycles 4-5 (28-day cycle): Participants received fludarabine 25 mg/m^2 IV and cyclophosphamide 250 mg/m^2 IV on Days 2, 3, and 4 and rituximab 375 mg/m^2 IV on Day 14, followed by 14 days of rest.~Cycles 7-10 (2-month cycle): Following 2 months rest after the completion of Cycle 6, participants with CR, CRu, or PR, received maintenance therapy with rituximab 375 mg/m^2 IV on Day 1, followed by 2 months rest; cycle was repeated 4 times."
877938|NCT01153958|B3|Baseline|Total|Total of all reporting groups
877939|NCT01153958|B2|Baseline|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877940|NCT01153958|B1|Baseline|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877941|NCT01153958|P2|Participant Flow|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877942|NCT01153958|P1|Participant Flow|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877943|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877944|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877945|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877946|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877947|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877948|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877949|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877950|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877951|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877952|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877953|NCT01153958|O2|Outcome|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877954|NCT01153958|O1|Outcome|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877955|NCT01153958|E2|Reported Event|Metronidazole|Metronidazole 400 milligram (mg) orally twice daily for 7 consecutive days
877956|NCT01153958|E1|Reported Event|Colposeptine|Colposeptine 1 capsule transvaginally daily for 12 consecutive days.
877957|NCT01153893|B3|Baseline|Total|Total of all reporting groups
877992|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
878078|NCT01153698|P1|Participant Flow|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
877960|NCT01153893|P2|Participant Flow|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877961|NCT01153893|P1|Participant Flow|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877962|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877963|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877964|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877965|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877966|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877967|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877968|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877969|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877970|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877971|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877972|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877973|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877974|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877975|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877976|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877977|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877978|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877979|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877980|NCT01153893|O2|Outcome|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877981|NCT01153893|O1|Outcome|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877982|NCT01153893|E2|Reported Event|Synflorix/Infanrix Unprimed Group|Unprimed subjects from the primary study NCT00678301, not previously vaccinated with any pneumococcal vaccine, received a 2-dose catch-up vaccination of Synflorix™ vaccine at 15-21 and 17-23 months of age and a booster dose of Infanrix™ vaccine co-administered with the first dose of Synflorix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877983|NCT01153893|E1|Reported Event|Synflorix/Infanrix Primed Group|Subjects previously primed with the Synflorix™ vaccine in the primary study NCT00678301 received a booster dose of the Synflorix™ vaccine co-administered with a booster dose of the Infanrix™ vaccine at 15-21 months of age. Synflorix™ vaccine was administered intramuscularly in the right thigh or deltoid muscle of the arm. Infanrix™ vaccine was administered intramuscularly in the left thigh or deltoid muscle of the arm.
877984|NCT01153841|B3|Baseline|Total|Total of all reporting groups
877985|NCT01153841|B2|Baseline|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877986|NCT01153841|B1|Baseline|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877987|NCT01153841|P2|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877988|NCT01153841|P1|Participant Flow|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877989|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877990|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877991|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
892152|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
877994|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877995|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877996|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877997|NCT01153841|O2|Outcome|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877998|NCT01153841|O1|Outcome|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
877999|NCT01153841|E2|Reported Event|Infanrix Hexa Group|Healthy male or female subjects who received the Infanrix hexa™ vaccine alone, administered intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
878000|NCT01153841|E1|Reported Event|Synflorix+Infanrix Hexa Group|Healthy male or female subjects who received the Synflorix™ vaccine, intramuscularly in the right thigh, co-administered along with the Infanrix hexa™ vaccine, intramuscularly in the left thigh, according to a 3-dose schedule at 2, 3 and 4 months of age.
878079|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
892153|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
878026|NCT01153763|B1|Baseline|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878027|NCT01153763|P1|Participant Flow|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878028|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878029|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878030|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878031|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878032|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878033|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878034|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878035|NCT01153763|O1|Outcome|GSK2118436 150 mg|Participants received GSK2118436 (gelatin capsules) 150 milligrams (mg) orally twice a day and continued on treatment until disease progression, death, or unacceptable adverse event. Participants who are benefiting from GSK2118436 at the time of study completion will have the option to enter Study BRF114144 (NCT01231594), which is a rollover study for GSK2118436.
878036|NCT01153763|E1|Reported Event|All Patients|Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
878037|NCT01153724|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
878071|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878331|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878038|NCT01153724|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 35 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 capsule Fluconazole 400 milligram once daily, both for 14 days (with a loading dose of 800 milligram on the first day).
878039|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878040|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878041|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878042|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878043|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878044|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878045|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878046|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878047|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878048|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878049|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878050|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878051|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878052|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878053|NCT01153724|O2|Outcome|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878054|NCT01153724|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878055|NCT01153724|E2|Reported Event|Olodaterol Plus Fluconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Fluconazole 400mg capsule administered orally once daily for 14 days.
878056|NCT01153724|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878057|NCT01153711|B1|Baseline|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
878058|NCT01153711|P1|Participant Flow|Overall Study|Total number of patients treated in the study. This was an open-label, fixed sequence, phase I trial in healthy volunteers. 32 subjects received in period 1 Olodaterol 10 microgram delivered by Respimat inhaler once daily for 8 days and in period 2 Olodaterol 10 microgram delivered by Respimat inhaler once daily plus 1 tablet Ketoconazole 400mg once daily, both for 14 days.
878059|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878060|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878061|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878062|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878063|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878064|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878065|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878066|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878067|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878068|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878069|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878070|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878144|NCT01153620|B2|Baseline|Lavasept 0.04%|
878072|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878073|NCT01153711|O2|Outcome|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878074|NCT01153711|O1|Outcome|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878075|NCT01153711|E2|Reported Event|Olodaterol Plus Ketoconazole|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 14 days plus Ketoconazole 400mg tablet administered orally once daily for 14 days.
878076|NCT01153711|E1|Reported Event|Olodaterol|Oral inhalation of Olodaterol 10 microgram solution with Respimat A5 device once daily for 8 days.
878077|NCT01153698|B1|Baseline|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
878085|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
878086|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
878087|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
878088|NCT01153698|O1|Outcome|All Patients|receiving at least one dose of enoxaparin 40mg or at least one dose of Pradaxa 220mg
878089|NCT01153698|E2|Reported Event|Pradaxa 220mg|All patients treated with Pradaxa
878090|NCT01153698|E1|Reported Event|Enoxaparin 40mg|All patients treated with enoxaparin
878091|NCT01153685|B3|Baseline|Total|Total of all reporting groups
878092|NCT01153685|B2|Baseline|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878093|NCT01153685|B1|Baseline|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878094|NCT01153685|P2|Participant Flow|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878095|NCT01153685|P1|Participant Flow|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878096|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878097|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878098|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878099|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878100|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878101|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878102|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878103|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878104|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878105|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878106|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878107|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878108|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878109|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878110|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878111|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878112|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878113|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878114|NCT01153685|O2|Outcome|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878115|NCT01153685|O1|Outcome|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878145|NCT01153620|B1|Baseline|Ringer's Solution|
878146|NCT01153620|P2|Participant Flow|Lavasept 0.04%|
878116|NCT01153685|E2|Reported Event|Fluviral B Group|Subjects over 60 years of age who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878117|NCT01153685|E1|Reported Event|Fluviral A Group|Subjects aged between 18 and 60 years who received one dose of Fluviral vaccine at Day 0, administered intramuscularly in the deltoid region of the non-dominant arm.
878118|NCT01153672|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
878187|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878119|NCT01153672|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
878120|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
878121|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
878122|NCT01153672|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
878123|NCT01153672|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, AI Sensitization Therapy)|"Patients receive vorinostat PO QD for 2 weeks followed by AI therapy comprising anastrozole PO QD, letrozole PO QD, OR exemestane PO QD for 6 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat: Given PO~laboratory biomarker analysis: Correlative studies~biopsy: Optional correlative studies~F-18 16 alpha-fluoroestradiol: Correlative studies~positron emission tomography: Correlative studies~anastrozole: Given PO~letrozole: Given PO~exemestane: Given PO~gene expression analysis: Correlative studies"
878124|NCT01153633|B3|Baseline|Total|Total of all reporting groups
878125|NCT01153633|B2|Baseline|Normal Saline and Placebo Gel|Sodium Choride 0.9% Solution, Neutral Gel without Polihexanide, without Betaine
878126|NCT01153633|B1|Baseline|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
878127|NCT01153633|P2|Participant Flow|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878128|NCT01153633|P1|Participant Flow|Prontosan Wound Solution and Gel|Polihexanide (0.1%), Betaine (0,1%), Purifed water
878129|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878130|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
878131|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878132|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
878133|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878134|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
878135|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878136|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
878137|NCT01153633|O2|Outcome|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878138|NCT01153633|O1|Outcome|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
878139|NCT01153633|O2|Outcome|Normal Saline and Inactive Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878140|NCT01153633|O1|Outcome|Prontosan Wound Irrigation Solution and Gel|Polihexanide 0.1%, Betaine 01.%, purified water, exipients
878141|NCT01153633|E2|Reported Event|Normal Saline and Placebo Gel|Sodium Chloride 0.9% Solution Inactive Hydrogel, Hydroxyethylcellulose, Glycerol, purified water, exipients
878142|NCT01153633|E1|Reported Event|Prontosan Wound Solution and Gel|Polihexanide 0.1%, Betaine 0.1%, purified water, exipients
878143|NCT01153620|B3|Baseline|Total|Total of all reporting groups
878148|NCT01153620|O2|Outcome|Ringer's Solution|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
878149|NCT01153620|O1|Outcome|Lavasept 0.04%|Reduction in log 10 Colony Forming Units after 60 minutes of treatment
878150|NCT01153620|E2|Reported Event|Lavasept 0.04%|
878151|NCT01153620|E1|Reported Event|Ringer's Solution|
878152|NCT01153581|B1|Baseline|Women|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
878188|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878153|NCT01153581|P1|Participant Flow|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
878154|NCT01153581|O2|Outcome|Women Without Orthostatic Tolerance|Women who pass out easily with gravitational challenge
878155|NCT01153581|O1|Outcome|Women With Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
878156|NCT01153581|O2|Outcome|High Orthostatic Tolerant|Women who can tolerate posture changes
878157|NCT01153581|O1|Outcome|Low Orthostatic Tolerance|Women who pass out easily in response to posture change
878158|NCT01153581|O1|Outcome|Women With and Without Orthostatic Intolerance|"Estrogen and Progesterone~17 beta estradiol, progesterone, ganirelix acetate: Antagon (for ganirelix acetate)--0.25 ml per day, subcutaneous injection estradiol 0.2 mg/day (patches) per day progesterone 200 mg per day, pills~17 beta estradiol, progesterone, ganirelix acetate: 17 beta estradiol: 0.2 mg/day (patches) progesterone 200 mg/day ganirelix acetate 0.25 mg/day"
878159|NCT01153581|E3|Reported Event|Progesterone|The same women added progesterone (P4, 200 mg day−1 Prometrium, oral, Solvay Pharmaceuticals, Marietta, GA, USA) on days 13–16.
878160|NCT01153581|E2|Reported Event|17β-Oestradiol|The same women added 17β-Oestradiol, E2; 0.2 mg day−1 patch (Vivelle; CIBA Pharmaceuticals, Summit, NJ) for days 4-16.
878161|NCT01153581|E1|Reported Event|Ganirelix Acetate|Ganirelix acetate (Organon, Roseland, NJ, USA), a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotrophin-releasing hormone (GnRH) to suppress GnRH. (250 μg in 0.5ml normal saline for 16 days).
878162|NCT01153503|B4|Baseline|Total|Total of all reporting groups
878163|NCT01153503|B3|Baseline|Ketorolac 30 mg IV|"Ketorolac 30 mg, IV at the end of surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
878164|NCT01153503|B2|Baseline|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
878165|NCT01153503|B1|Baseline|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
878166|NCT01153503|P3|Participant Flow|Ketorolac 30 mg|"Ketorolac 30 mg, IV at the end of surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine 24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
878167|NCT01153503|P2|Participant Flow|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h Postoperative: IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
878168|NCT01153503|P1|Participant Flow|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP blocks and Ketorolac 30 mg IV at the end of the surgery~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h and IV-PCA morphine~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
878169|NCT01153503|O3|Outcome|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
878170|NCT01153503|O2|Outcome|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
878171|NCT01153503|O1|Outcome|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
878172|NCT01153503|E3|Reported Event|Ketorolac 30 mg|"Ketorolac 30 mg after surgery~First 24-h postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine"
878173|NCT01153503|E2|Reported Event|TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery+ IV-PCA morphine~First 24-h postoperative: IV-PCA morphine"
878174|NCT01153503|E1|Reported Event|Ketorolac 30 mg, IV + TAP Block|"Bilateral ultrasound-guided TAP block at the end of the surgery~First 24-h postoperative: Ketorolac 30 mg, IV, every 6h + acetaminophen 650 mg, orally, every 6h + IV-PCA morphine"
878175|NCT01153347|B5|Baseline|Total|Total of all reporting groups
878176|NCT01153347|B4|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878177|NCT01153347|B3|Baseline|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878178|NCT01153347|B2|Baseline|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878179|NCT01153347|B1|Baseline|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878180|NCT01153347|P4|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878181|NCT01153347|P3|Participant Flow|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878182|NCT01153347|P2|Participant Flow|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878183|NCT01153347|P1|Participant Flow|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878184|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878185|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878186|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878342|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878189|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878190|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878191|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878192|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878193|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878194|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878195|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878196|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878197|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878198|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878199|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878200|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878201|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878202|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878203|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878204|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878205|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878206|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878207|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878208|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878209|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878210|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878211|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878212|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878213|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878214|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878215|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878216|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878217|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878218|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878219|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878220|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878221|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878222|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878223|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878224|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878332|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878225|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878226|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878227|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878228|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878229|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878230|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878231|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878232|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878233|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878234|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878235|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878236|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878237|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878238|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878239|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878240|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878241|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878242|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878243|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878244|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878245|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878246|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878247|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878248|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878249|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878250|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878251|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878252|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878253|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878254|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878255|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878256|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878257|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878258|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878259|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878260|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878261|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878262|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878263|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878264|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878265|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878266|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878267|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878268|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878269|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878270|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878271|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878272|NCT01153347|O4|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
892154|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
878273|NCT01153347|O3|Outcome|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878274|NCT01153347|O2|Outcome|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878275|NCT01153347|O1|Outcome|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878276|NCT01153347|E4|Reported Event|4 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 4 mg BID
878277|NCT01153347|E3|Reported Event|2 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 2 mg BID
878278|NCT01153347|E2|Reported Event|0.5 mg BID TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 0.5 mg BID
878279|NCT01153347|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
878280|NCT01153321|B3|Baseline|Total|Total of all reporting groups
878281|NCT01153321|B2|Baseline|Placebo|Placebo to match AZD2423 tablets, once daily
878282|NCT01153321|B1|Baseline|AZD2423|Two 50 mg AZD2423 tablets, once daily
878283|NCT01153321|P2|Participant Flow|Placebo|Placebo to match AZD2423 tablets, once daily
878284|NCT01153321|P1|Participant Flow|AZD2423|Two 50 mg AZD2423 tablets, once daily
878285|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878286|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878287|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878288|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878289|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878290|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878291|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878292|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878293|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878294|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878295|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878296|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878297|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878298|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878299|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878300|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878301|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878302|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878303|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878304|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878305|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878306|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878307|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878308|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878309|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878310|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878311|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878312|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878313|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878314|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878315|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878316|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878317|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878318|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878319|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878320|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878321|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878322|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878323|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878324|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878325|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878326|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878327|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878328|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878329|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878330|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878333|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878334|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878335|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878336|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878337|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878338|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878339|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878340|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878341|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878346|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878347|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878348|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878349|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878350|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878351|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878352|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878353|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878354|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878355|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878356|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878357|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878358|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878359|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878360|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878361|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878362|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878363|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878364|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878365|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878366|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878367|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878368|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878369|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878370|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878371|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878372|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878373|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878374|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878375|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878376|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878377|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878378|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878379|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878380|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878381|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878382|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878383|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878384|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878385|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878386|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878387|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878388|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878389|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878390|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878391|NCT01153321|O2|Outcome|Placebo|Placebo to match AZD2423 tablets, once daily
878392|NCT01153321|O1|Outcome|AZD2423|Two 50 mg AZD2423 tablets, once daily
878393|NCT01153321|E2|Reported Event|Placebo|Placebo to match AZD2423 tablets, once daily
878394|NCT01153321|E1|Reported Event|AZD2423 100 mg|
878395|NCT01153269|B1|Baseline|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878396|NCT01153269|P1|Participant Flow|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878397|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
878398|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878399|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878400|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878401|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878402|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878403|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878404|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878405|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878406|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878407|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878408|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878409|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
878410|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878411|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878412|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878413|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
878414|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
878415|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878416|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878417|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
878418|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878419|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878420|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
878421|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878422|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878423|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878424|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C
878425|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878426|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878427|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878428|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878429|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878430|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878431|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878432|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878433|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878434|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878435|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878436|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878437|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878438|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878439|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878440|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878441|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878442|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878701|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878443|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878444|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878445|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878446|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878710|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878447|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878448|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878449|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878450|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878451|NCT01153269|O2|Outcome|HIV-infected Participants With Hepatitis Co-infection: ALT|Alanine aminotransferase (ALT) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878452|NCT01153269|O1|Outcome|HIV-infected Participants With Hepatitis Co-infection: AST|Aspartate aminotransferase (AST) results for HIV-infected participants with hepatitis B or hepatitis C co-infection.
878453|NCT01153269|E1|Reported Event|HIV-infected Participants With Hepatitis Co-infection|HIV-infected participants with co-infections of hepatitis B or hepatitis C.
878454|NCT01153009|B5|Baseline|Total|Total of all reporting groups
878455|NCT01153009|B4|Baseline|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878456|NCT01153009|B3|Baseline|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878457|NCT01153009|B2|Baseline|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878458|NCT01153009|B1|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878459|NCT01153009|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878460|NCT01153009|P3|Participant Flow|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878461|NCT01153009|P2|Participant Flow|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878462|NCT01153009|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878463|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878464|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878465|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878466|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878467|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878468|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878469|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878470|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878471|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878472|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878473|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878474|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878475|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878814|NCT01151579|B3|Baseline|Total|Total of all reporting groups
878476|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878477|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878478|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878479|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878593|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878480|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878481|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878482|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878483|NCT01153009|O4|Outcome|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878484|NCT01153009|O3|Outcome|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878485|NCT01153009|O2|Outcome|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878486|NCT01153009|O1|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878487|NCT01153009|E4|Reported Event|Duloxetine 60 mg|Duloxetine 30 mg capsules, orally, once daily for one week then duloxetine 60 mg, capsules, orally, once daily for 7 weeks, then duloxetine 30 mg capsules, once daily, for one week.
878488|NCT01153009|E3|Reported Event|Vortioxetine 20 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 20 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878489|NCT01153009|E2|Reported Event|Vortioxetine 15 mg|Vortioxetine 10 mg, encapsulated tablets, orally, once daily for one week, then vortioxetine 15 mg, encapsulated tablets, orally, once daily for 7 weeks, then placebo-matching capsules, orally, once daily for one week.
878490|NCT01153009|E1|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 9 weeks.
878491|NCT01152996|B1|Baseline|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878492|NCT01152996|P1|Participant Flow|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878493|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878494|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878495|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878496|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878497|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878498|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878499|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878500|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878501|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878502|NCT01152996|O1|Outcome|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878503|NCT01152996|E1|Reported Event|Vortioxetine|Vortioxetine 10 mg, capsules, orally, once daily for the first week of treatment; then vortioxetine up-titrated to 15 mg or 20 mg, capsules, orally, once daily for up to 51 weeks.
878504|NCT01152814|B1|Baseline|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
878505|NCT01152814|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) dose of 0.5 milliliter (mL) of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
878542|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878506|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
878507|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
878508|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
878509|NCT01152814|O1|Outcome|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
878594|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878510|NCT01152814|E1|Reported Event|FLUAD|Participants received a single IM dose of 0.5 mL of FLUAD containing 15μg each of the three influenza antigens into the deltoid region of the non-dominant arm during the vaccination visit, according to the study protocol until Day 22.
878511|NCT01152788|B3|Baseline|Total|Total of all reporting groups
878512|NCT01152788|B2|Baseline|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
878513|NCT01152788|B1|Baseline|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
878514|NCT01152788|P2|Participant Flow|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
878515|NCT01152788|P1|Participant Flow|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
878516|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
878517|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
878518|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
878519|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
878520|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
878521|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
878522|NCT01152788|O2|Outcome|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
878523|NCT01152788|O1|Outcome|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
878524|NCT01152788|E2|Reported Event|Dacarbazine|Dacarbazine: 1000 mg/m2 IV Day 1, every 3 weeks
878525|NCT01152788|E1|Reported Event|rIL-21|rIL-21: 30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
878526|NCT01152697|B1|Baseline|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878527|NCT01152697|P1|Participant Flow|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE). Dosage form was a long acting injectable administered every three to five weeks. Mean endpoint dose was 68.0 mg.
878528|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878529|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878530|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878531|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878532|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878533|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878534|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878535|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878536|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878537|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878538|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878539|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878540|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878541|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878543|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878544|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878545|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878546|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878547|NCT01152697|O1|Outcome|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878548|NCT01152697|E1|Reported Event|Patient Noncompliance|Only one arm for this study. Interventions given were as follows: study drugs haloperidol decanoate or haloperidol and behavioral intervention called Customized Adherence Enhancement (CAE).
878549|NCT01152580|B3|Baseline|Total|Total of all reporting groups
878550|NCT01152580|B2|Baseline|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878551|NCT01152580|B1|Baseline|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878552|NCT01152580|P2|Participant Flow|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878553|NCT01152580|P1|Participant Flow|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878554|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878555|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878556|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878557|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878558|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878559|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878560|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878561|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878562|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878563|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878564|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878565|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878566|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878567|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878568|NCT01152580|O2|Outcome|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878569|NCT01152580|O1|Outcome|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878570|NCT01152580|E2|Reported Event|Melatonin|Each capsule contained 3 mg melatonin and each subject was asked to take this nightly p.o. for 6 months
878571|NCT01152580|E1|Reported Event|Sugar Pill|Each capsule contained lactose and the study subjects took this nightly, p.o. for 6 months
878572|NCT01152554|B3|Baseline|Total|Total of all reporting groups
878573|NCT01152554|B2|Baseline|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878574|NCT01152554|B1|Baseline|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878575|NCT01152554|P2|Participant Flow|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878576|NCT01152554|P1|Participant Flow|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878577|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878578|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878579|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878580|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878581|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878582|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878583|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878584|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878585|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878586|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878587|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878588|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878589|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878590|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878591|NCT01152554|O2|Outcome|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo BID
878592|NCT01152554|O1|Outcome|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878595|NCT01152554|E2|Reported Event|TC-5214|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + TC-5214, 1-4 mg BID
878596|NCT01152554|E1|Reported Event|Placebo|Selective serotonin reuptake inhibitor (SSRI)/Serotonin/norepinephrine reuptake inhibitor (SNRI) + Placebo
878597|NCT01152450|B1|Baseline|Baseline Total|Total number of patients randomised and treated in the study.
878598|NCT01152450|P6|Participant Flow|Placebo/Tio R5 qd/Tio R2.5 Bid|Patients treated with a matching Placebo in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
878599|NCT01152450|P5|Participant Flow|Placebo/Tio R2.5 Bid/Tio R5 qd|Patients treated with matching Placebo in period 1 (morning and evening), with Tiotropium 2.5 mcg in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
878600|NCT01152450|P4|Participant Flow|Tio R5 qd/Placebo/Tio R2.5 Bid|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with matching Placebo in period 2 (morning and evening) and with Tiotropium 2.5 mcg in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
878601|NCT01152450|P3|Participant Flow|Tio R5 qd/Tio R2.5 Bid/Placebo|Patients treated with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 1, with Tiotropium 2.5 mcg in period 2 (morning and evening) and with matching Placebo in period 3 (morning and evening) . All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
878602|NCT01152450|P2|Participant Flow|Tio R2.5 Bid/Placebo/Tio R5 qd|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching Placebo in period 2 (morning and evening) and with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 3. All products were delivered by the Respimat inhaler, on top on maintenance therapy with iCS. No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
878603|NCT01152450|P1|Participant Flow|Tio R2.5 Twice Daily (Bid) /Tio R5 Once Daily (qd) /Placebo|Patients treated with Tiotropium 2.5 mcg in period 1 (morning and evening), with a matching placebo in the morning and Tiotropium 5 mcg in the evening in period 2 and with a matching Placebo in period 3 (morning and evening). All products were delivered by the Respimat inhaler, on top on maintenance therapy with inhaled corticosteroid (iCS). No washouts (off-treatment periods) between treatments. Duration of each treatment period was 4 weeks.
878604|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878605|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878606|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878607|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878608|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878609|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878610|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878611|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878612|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878613|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878614|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878615|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878616|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878617|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878618|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878619|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878620|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878621|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878622|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878623|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878624|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878625|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
892155|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
878626|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878627|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878628|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878629|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878630|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878631|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878632|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878633|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878634|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878635|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878636|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878637|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878638|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878639|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878640|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878641|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878642|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878643|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878644|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878645|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878646|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878647|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878648|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878649|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878650|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878651|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878652|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878653|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878654|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878655|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878656|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878657|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878658|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878659|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878660|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878661|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878662|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878663|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878664|NCT01152450|O3|Outcome|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878665|NCT01152450|O2|Outcome|Tio R2.5 Bid|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878666|NCT01152450|O1|Outcome|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878709|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878667|NCT01152450|E3|Reported Event|Tio R5 qd|Tiotropium 5 mcg qd in the evening and matching placebo qd in the morning delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878668|NCT01152450|E2|Reported Event|Tio R2.5|Tiotropium 2.5 mcg bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878669|NCT01152450|E1|Reported Event|Placebo|Matching Placebo bid morning and evening delivered by the Respimat inhaler, on top on maintenance therapy with iCS.
878670|NCT01152437|B4|Baseline|Total|Total of all reporting groups
878671|NCT01152437|B3|Baseline|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878672|NCT01152437|B2|Baseline|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
878673|NCT01152437|B1|Baseline|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878674|NCT01152437|P3|Participant Flow|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878675|NCT01152437|P2|Participant Flow|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
878676|NCT01152437|P1|Participant Flow|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878677|NCT01152437|O2|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878678|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878679|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878680|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
878681|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878682|NCT01152437|O3|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878683|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
878684|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878685|NCT01152437|O1|Outcome|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878686|NCT01152437|O2|Outcome|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
878687|NCT01152437|O1|Outcome|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878688|NCT01152437|E3|Reported Event|Afatinib (Mutated)|Afatinib tablets once daily in patients with KRAS mutated metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878689|NCT01152437|E2|Reported Event|Cetuximab (Wild-type)|Cetuximab 400 mg/m² on Day 1 and then 250mg/m² once a week, every week, intravenous (i.v.) in patients with KRAS wild-type metastatic colorectal cancer.
878690|NCT01152437|E1|Reported Event|Afatinib (Wild-type)|Afatinib tablets once daily in patients with KRAS (v-Ki-ras2 Kirsten rat sarcoma viral oncogene homolog) wild-type metastatic colorectal cancer. Patients started on 40 mg and then increased to 50 mg after 4 weeks if well tolerated.
878691|NCT01152385|B5|Baseline|Total|Total of all reporting groups
878692|NCT01152385|B4|Baseline|Placebo|Placebo
878693|NCT01152385|B3|Baseline|Low Dose|80 mg (daily dose)
878694|NCT01152385|B2|Baseline|Middle Dose|140 mg (daily dose)
878695|NCT01152385|B1|Baseline|High Dose|200 mg (daily dose)
878696|NCT01152385|P4|Participant Flow|Placebo|Placebo
878697|NCT01152385|P3|Participant Flow|Low Dose|80 mg (daily dose)
878698|NCT01152385|P2|Participant Flow|Middle Dose|140 mg (daily dose)
878699|NCT01152385|P1|Participant Flow|High Dose|200 mg (daily dose)
878702|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878703|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878704|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
878705|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878706|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878707|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878708|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
892156|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
878711|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878712|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
878713|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878714|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878715|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878716|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
878717|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878718|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878719|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878720|NCT01152385|O4|Outcome|Arm 4 - Placebo|Placebo
878721|NCT01152385|O3|Outcome|Arm 3 - Low|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878722|NCT01152385|O2|Outcome|Arm 2 - Middle|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878723|NCT01152385|O1|Outcome|Arm 1 - High|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878724|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
878725|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878726|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878727|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878728|NCT01152385|O4|Outcome|Arm 4 - Placebo Dose|Placebo
878729|NCT01152385|O3|Outcome|Arm 3 - Low Dose|AZD1656 titration 10 - 20 - 40 - 80 mg (daily dose)
878730|NCT01152385|O2|Outcome|Arm 2 - Middle Dose|AZD1656 titration 20 - 40 - 80 - 140 mg (daily dose)
878731|NCT01152385|O1|Outcome|Arm 1 - High Dose|AZD1656 titration 40 - 80 - 140 - 200 mg (daily dose)
878732|NCT01152385|E4|Reported Event|Placebo|Placebo
878733|NCT01152385|E3|Reported Event|Low Dose|80 mg (daily dose)
878734|NCT01152385|E2|Reported Event|Middle Dose|140 mg (daily dose)
878735|NCT01152385|E1|Reported Event|High Dose|200 mg (daily dose)
878736|NCT01152359|B3|Baseline|Total|Total of all reporting groups
878737|NCT01152359|B2|Baseline|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
878738|NCT01152359|B1|Baseline|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
878739|NCT01152359|P2|Participant Flow|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
878740|NCT01152359|P1|Participant Flow|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
878741|NCT01152359|O2|Outcome|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
878742|NCT01152359|O1|Outcome|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
917341|NCT01037218|O4|Outcome|Placebo|Placebo tablets
878743|NCT01152359|E2|Reported Event|Arm 2|Upon starting the study, participants are randomly assigned to a low-carbohydrate or a low-fat diet for weight loss. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
878788|NCT01151852|P1|Participant Flow|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878744|NCT01152359|E1|Reported Event|Arm 1|Upon starting the study, participants are able to make an informed choice between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and about their food preferences as assessed by a questionnaire. Then participants will receive counseling regarding their chosen diet in a small group format. Sessions will take place every 2 weeks for 24 weeks then group sessions will alternate with telephone calls every 2 weeks for 24 weeks. Phone calls will focus on goal setting to maximize weight loss. In addition to counseling on diet during group sessions and phone calls, participants will receive counseling on behavioral techniques and physical activity.
878745|NCT01152307|B3|Baseline|Total|Total of all reporting groups
878746|NCT01152307|B2|Baseline|Control|Group not receiving the decision aid (DVD/booklet)
878747|NCT01152307|B1|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
878748|NCT01152307|P2|Participant Flow|Control|Group not receiving the decision aid (DVD/booklet)
878749|NCT01152307|P1|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
878750|NCT01152307|O2|Outcome|Control|Group not receiving the decision aid (DVD/booklet)
878751|NCT01152307|O1|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
878752|NCT01152307|E2|Reported Event|Control|Group not receiving the decision aid (DVD/booklet)
878753|NCT01152307|E1|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
878754|NCT01152294|B3|Baseline|Total|Total of all reporting groups
878755|NCT01152294|B2|Baseline|Decision Aid|Group receiving the decision aid (DVD/booklet)
878756|NCT01152294|B1|Baseline|Control|Group not receiving the decision aid (DVD and booklet)
878757|NCT01152294|P2|Participant Flow|Decision Aid|Group receiving the decision aid (DVD/booklet)
878758|NCT01152294|P1|Participant Flow|Control|Group not receiving the decision aid (DVD and booklet)
878759|NCT01152294|O2|Outcome|Decision Aid|Group receiving the decision aid (DVD/booklet)
878760|NCT01152294|O1|Outcome|Control|Group not receiving the decision aid (DVD and booklet)
878761|NCT01152294|E2|Reported Event|Decision Aid|Group receiving the decision aid (DVD/booklet)
878762|NCT01152294|E1|Reported Event|Control|Group not receiving the decision aid (DVD and booklet)
878763|NCT01152190|B3|Baseline|Total|Total of all reporting groups
878764|NCT01152190|B2|Baseline|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
878765|NCT01152190|B1|Baseline|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
878766|NCT01152190|P2|Participant Flow|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
878767|NCT01152190|P1|Participant Flow|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
878768|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
878769|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
878770|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
878771|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
878772|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
878773|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
878774|NCT01152190|O2|Outcome|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
878775|NCT01152190|O1|Outcome|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
878776|NCT01152190|E2|Reported Event|Tadalafil|Tadalafil: 5-milligram (mg) tablet administered orally, once daily for 8 weeks.
878777|NCT01152190|E1|Reported Event|Placebo|Placebo: tablet administered orally, once daily for 8 weeks.
878778|NCT01151904|B1|Baseline|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
878779|NCT01151904|P1|Participant Flow|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
878780|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
878781|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
878782|NCT01151904|O1|Outcome|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
878783|NCT01151904|E1|Reported Event|COMBIGAN® With Latanoprost|Patients on current latanoprost monotherapy that qualify for study entry will have COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) added to the latanoprost for 12 additional weeks.
878784|NCT01151852|B3|Baseline|Total|Total of all reporting groups
878815|NCT01151579|B2|Baseline|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
917342|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
878785|NCT01151852|B2|Baseline|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878786|NCT01151852|B1|Baseline|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878787|NCT01151852|P2|Participant Flow|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878821|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
879764|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
878789|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878790|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878791|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878792|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878793|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878794|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878795|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878796|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878797|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878798|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878799|NCT01151852|O2|Outcome|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878800|NCT01151852|O1|Outcome|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878801|NCT01151852|E2|Reported Event|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
878802|NCT01151852|E1|Reported Event|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
878803|NCT01151761|B1|Baseline|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
878804|NCT01151761|P1|Participant Flow|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
878805|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878806|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878807|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878808|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878809|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878810|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878811|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878812|NCT01151761|O1|Outcome|SBRT and Chemo|The patients in this arm receive SBRT and chemo in the hope of surviving long enough to have a liver transplantation
878813|NCT01151761|E1|Reported Event|SBRT, Chemotherapy and Liver Transplantation|The patients received Stereotactic Body Radiotherapy and Chemotherapy followed by a liver transplantation. The chemo could be any combination of the following: Gemcitabine, Cisplatin, Carboplatin, Capecitabine and 5FU
878816|NCT01151579|B1|Baseline|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
878817|NCT01151579|P2|Participant Flow|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
878818|NCT01151579|P1|Participant Flow|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
878819|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
878820|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
878822|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
878823|NCT01151579|O2|Outcome|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
878824|NCT01151579|O1|Outcome|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
878825|NCT01151579|E2|Reported Event|Levalbuterol 1.25|Patients received an initial dose of levalbuterol 1.25 mg alternating with albuterol 2.5 mg.
878826|NCT01151579|E1|Reported Event|Nebulized Albuterol 2.5mg|Patients were randomized to receive an initial dose of albuterol 2.5 mg alternating with levalbuterol 0.63 mg.
878827|NCT01151553|B1|Baseline|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
878828|NCT01151553|P1|Participant Flow|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
878829|NCT01151553|O1|Outcome|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
878830|NCT01151553|E1|Reported Event|Patients With CHF With CRT Therapy|"Patients with CHF with CRT Therapy~CRT Therapy : Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk"
878831|NCT01151449|B1|Baseline|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878832|NCT01151449|P1|Participant Flow|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878833|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878834|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878835|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878836|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878837|NCT01151449|O1|Outcome|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878838|NCT01151449|E1|Reported Event|Treatment (Gamma-secretase/Notch Signalling Pathway Inhibitor)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO once daily on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given orally~laboratory biomarker analysis: Correlative studies"
878839|NCT01151436|B1|Baseline|Hyaluronic Acid|
878840|NCT01151436|P1|Participant Flow|Hyaluronic Acid|
878841|NCT01151436|O1|Outcome|Hyaluronic Acid|
878842|NCT01151436|O1|Outcome|Hyaluronic Acid|
878843|NCT01151436|O1|Outcome|Hyaluronic Acid|
878844|NCT01151436|O1|Outcome|Hyaluronic Acid|
878845|NCT01151436|O1|Outcome|Hyaluronic Acid|
878846|NCT01151436|O1|Outcome|Hyaluronic Acid|
878847|NCT01151436|O1|Outcome|Hyaluronic Acid|
878848|NCT01151436|O1|Outcome|Hyaluronic Acid|
878849|NCT01151436|O1|Outcome|Hyaluronic Acid|
878850|NCT01151436|O1|Outcome|Hyaluronic Acid|
878851|NCT01151436|O1|Outcome|Hyaluronic Acid|
878852|NCT01151436|O1|Outcome|Hyaluronic Acid|
878870|NCT01151410|B2|Baseline|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
878871|NCT01151410|B1|Baseline|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
878872|NCT01151410|P2|Participant Flow|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
878873|NCT01151410|P1|Participant Flow|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
878874|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
878875|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
878876|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
878877|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
878878|NCT01151410|O2|Outcome|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
878879|NCT01151410|O1|Outcome|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
878880|NCT01151410|E2|Reported Event|Enalapril|Patients will receive one of the following doses based on their weight: Low weight (≥20 to <50 kg) patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg Mid weight (≥50 to <80 kg) patients: Starting dose 5 mg with optional titration to 10 and then 20 mg High weight (≥80 to ≤150 kg) patients: Starting dose 10 mg with optional titration to 20 and then 40 mg
878881|NCT01151410|E1|Reported Event|Aliskiren|Patients will receive one of the following doses based on the their weight: Low weight (≥20 to <50 kg) patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg Mid weight (≥50 to <80 kg) patients: Starting dose 75 mg with optional titration to 150 and then 300 mg High weight (≥80 to ≤150 kg) patients: Starting dose 150 mg with optional titration to 300 and then 600 mg
878882|NCT01151371|B4|Baseline|Total|Total of all reporting groups
878883|NCT01151371|B3|Baseline|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878884|NCT01151371|B2|Baseline|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878885|NCT01151371|B1|Baseline|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878886|NCT01151371|P3|Participant Flow|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878887|NCT01151371|P2|Participant Flow|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878888|NCT01151371|P1|Participant Flow|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878889|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878890|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878891|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878892|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878893|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878894|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878895|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878896|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878897|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878898|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878899|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878900|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878901|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878902|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878903|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878904|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878905|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878906|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878907|NCT01151371|O2|Outcome|Lotrafilcon B|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878908|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878909|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878910|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878911|NCT01151371|O2|Outcome|Nelfilcon A|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878912|NCT01151371|O1|Outcome|Narafilcon B|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878913|NCT01151371|E3|Reported Event|Lotrafilcon B 4 Weeks|lenses worn daily on a 1-month replacement schedule, for 4 weeks
878914|NCT01151371|E2|Reported Event|Nelfilcon A 1 Week|lenses worn daily on a daily disposable/replacement schedule, for 1 week
878915|NCT01151371|E1|Reported Event|Narafilcon B 4 Weeks|lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
878916|NCT01151345|B1|Baseline|Entire Study Population|Includes groups randomized to receive any treatment (Tilazem 60 mg tablet first or Angiotrofin 60 mg tablet first )
878917|NCT01151345|P2|Participant Flow|Angiotrofin 60 mg Then Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Tilazem®) in second intervention period after 7 day clearance period.The total study duration was 9 days.
878918|NCT01151345|P1|Participant Flow|Tilazem 60 mg Then Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in first intervention period and single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in second intervention period after 7 day clearance period. The total study duration was 9 days.
878919|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
878920|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
878921|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
878922|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
878923|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
878924|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
878925|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
878926|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
878927|NCT01151345|O2|Outcome|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
878928|NCT01151345|O1|Outcome|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
878929|NCT01151345|E2|Reported Event|Angiotrofin 60 mg|Single oral dose of 60 mg Diltiazem tablet (Angiotrofin®) in either first intervention period or second intervention period.
878930|NCT01151345|E1|Reported Event|Tilazem 60 mg|Single oral dose of 60 mg Diltiazem tablet (Tilazem®) in either first intervention period or second intervention period.
878931|NCT01151280|B1|Baseline|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878932|NCT01151280|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878933|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878934|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878935|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878936|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878937|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878938|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878939|NCT01151280|O1|Outcome|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878940|NCT01151280|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Patients who signed an informed consent form and who met the inclusion/exclusion criteria for the study received a WallFlex Biliary Fully Covered Stent for treatment of anastomotic stricture post orthotopic liver transplant.
878941|NCT01151215|B4|Baseline|Total|Total of all reporting groups
878942|NCT01151215|B3|Baseline|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
878943|NCT01151215|B2|Baseline|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
878944|NCT01151215|B1|Baseline|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
878945|NCT01151215|P3|Participant Flow|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
878946|NCT01151215|P2|Participant Flow|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
878947|NCT01151215|P1|Participant Flow|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
878948|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
878949|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
878950|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
878951|NCT01151215|O3|Outcome|Placebo + Anastrozole 1mg|Placebo (bd) plus anastrozole 1mg (od)
878952|NCT01151215|O2|Outcome|AZD8931 20mg + Anastrozole 1mg|AZD8931 20mg (bd) plus anastrozole 1mg (od)
878953|NCT01151215|O1|Outcome|AZD8931 40mg + Anastrozole 1mg|AZD8931 40mg (bd) plus anastrozole 1mg (od)
878954|NCT01151215|E3|Reported Event|Placebo|
878955|NCT01151215|E2|Reported Event|AZD8931 40mg|
878956|NCT01151215|E1|Reported Event|AZD8931 20mg|
878957|NCT01151189|B3|Baseline|Total|Total of all reporting groups
878958|NCT01151189|B2|Baseline|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
878959|NCT01151189|B1|Baseline|Placebo|Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
878960|NCT01151189|P2|Participant Flow|MVA85A/AERAS-485|"MVA85A/AERAS-485 is a recombinant modified vaccinia virus Ankara expressing the M. tuberculosis antigen, Ag85A. Dosage of the study vaccine to be administered will be 1x10^8 pfu.~MVA85A/AERAS-485: Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485."
878961|NCT01151189|P1|Participant Flow|Placebo|"The placebo is a licensed product manufactured by Allermed, Inc. and is used for evaluation of delayed-type of hypersensitivity reactions in adults.~Placebo: Subjects were to receive an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo."
878962|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878963|NCT01151189|O1|Outcome|Placebo|
878964|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878965|NCT01151189|O1|Outcome|Placebo|
878966|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878967|NCT01151189|O1|Outcome|Placebo|
878968|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878969|NCT01151189|O1|Outcome|Placebo|
878970|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878971|NCT01151189|O1|Outcome|Placebo|
878972|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878973|NCT01151189|O1|Outcome|Placebo|
878974|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878975|NCT01151189|O1|Outcome|Placebo|
878976|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878977|NCT01151189|O1|Outcome|Placebo|
878978|NCT01151189|O2|Outcome|MVA85A/AERAS-485|
878979|NCT01151189|O1|Outcome|Placebo|
878980|NCT01151189|E2|Reported Event|MVA85A/AERAS-485|
878981|NCT01151189|E1|Reported Event|Placebo|
878982|NCT01151137|B3|Baseline|Total|Total of all reporting groups
878983|NCT01151137|B2|Baseline|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878984|NCT01151137|B1|Baseline|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
878985|NCT01151137|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878986|NCT01151137|P1|Participant Flow|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
878987|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878988|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
878989|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878990|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
878991|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878992|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
878993|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878994|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
878995|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878996|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
892157|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
878997|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
878998|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
878999|NCT01151137|O2|Outcome|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
879000|NCT01151137|O1|Outcome|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
879001|NCT01151137|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice daily until the CSED (median treatment duration of 74 days)
879002|NCT01151137|E1|Reported Event|Placebo|Placebo twice daily until the CSED (median treatment duration of 87.5 days)
879003|NCT01151098|B1|Baseline|Extension Phase (BTDS 5, 10 or 20)|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
879004|NCT01151098|P1|Participant Flow|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
879005|NCT01151098|O1|Outcome|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10, or 20) applied for 7-day wear.
879006|NCT01151098|E1|Reported Event|Total Extension Phase|Buprenorphine transdermal patches (BTDS 5, 10 or 20) applied for 7-day wear.
879007|NCT01151085|B1|Baseline|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
879008|NCT01151085|P1|Participant Flow|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
879009|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
879010|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
879011|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
879012|NCT01151085|O2|Outcome|Without Past History|Participants without Past History who taking Voriconazole according to Japanese Package Insert.
879013|NCT01151085|O1|Outcome|With Past History|Participants with Past History who taking Voriconazole according to Japanese Package Insert.
879014|NCT01151085|O3|Outcome|Severe Infection|Participants with severe infection who taking Voriconazole according to Japanese Package Insert.
879015|NCT01151085|O2|Outcome|Moderate Infection|Participants with moderate infection who taking Voriconazole according to Japanese Package Insert.
879016|NCT01151085|O1|Outcome|Mild Infection|Participants with mild infection who taking Voriconazole according to Japanese Package Insert.
879017|NCT01151085|O2|Outcome|Female|Female Participants taking Voriconazole according to Japanese Package Insert.
879018|NCT01151085|O1|Outcome|Male|Male Participants taking Voriconazole according to Japanese Package Insert.
879019|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
879020|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
879021|NCT01151085|O1|Outcome|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
879022|NCT01151085|E1|Reported Event|Voriconazole|Participants taking Voriconazole according to Japanese Package Insert.
879023|NCT01151046|B3|Baseline|Total|Total of all reporting groups
879024|NCT01151046|B2|Baseline|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879025|NCT01151046|B1|Baseline|MM-121 + Exemestane|MM-121 and Exemestane: MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879026|NCT01151046|P2|Participant Flow|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879027|NCT01151046|P1|Participant Flow|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
879028|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879029|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
879030|NCT01151046|O4|Outcome|HRG Low: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
879031|NCT01151046|O3|Outcome|HRG Low: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879032|NCT01151046|O2|Outcome|HRG High: Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879033|NCT01151046|O1|Outcome|HRG High: MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
879034|NCT01151046|O2|Outcome|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879035|NCT01151046|O1|Outcome|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
879036|NCT01151046|E2|Reported Event|Placebo + Exemestane|Placebo and Exemestane: Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week plus exemestane (25 mg) administered orally once per day
879037|NCT01151046|E1|Reported Event|MM-121 + Exemestane|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week, plus exemestane (25 mg) administered orally once per day
879887|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879038|NCT01151020|B1|Baseline|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
879039|NCT01151020|P1|Participant Flow|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
879040|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
879041|NCT01151020|O1|Outcome|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
879042|NCT01151020|E1|Reported Event|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
879043|NCT01150981|B3|Baseline|Total|Total of all reporting groups
879044|NCT01150981|B2|Baseline|Placebo|One capsule daily for 6 weeks.
879045|NCT01150981|B1|Baseline|Rosiglitazone|One 8mg capsule daily for 6 weeks.
879046|NCT01150981|P2|Participant Flow|Placebo|One capsule daily for 6 weeks.
879047|NCT01150981|P1|Participant Flow|Rosiglitazone|One 8mg capsule daily for 6 weeks.
879048|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
879049|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
879050|NCT01150981|O2|Outcome|Placebo|One capsule daily for 6 weeks.
879051|NCT01150981|O1|Outcome|Rosiglitazone|One 8mg capsule daily for 6 weeks.
879052|NCT01150981|E2|Reported Event|Placebo|One capsule daily for 6 weeks.
879053|NCT01150981|E1|Reported Event|Rosiglitazone|One 8mg capsule daily for 6 weeks.
879054|NCT01150903|B3|Baseline|Total|Total of all reporting groups
879055|NCT01150903|B2|Baseline|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
879056|NCT01150903|B1|Baseline|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879057|NCT01150903|P2|Participant Flow|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
879058|NCT01150903|P1|Participant Flow|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879059|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879060|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879061|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879062|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879063|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879064|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879065|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
879066|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879067|NCT01150903|O2|Outcome|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
879068|NCT01150903|O1|Outcome|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879069|NCT01150903|E2|Reported Event|Control (Without PDE5i Prescription)|Age-matched participants without any PDE5i (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the UK-THIN database (control population).
879070|NCT01150903|E1|Reported Event|Index PDE5i Prescription|Participants who received index phosphodiesterase type 5 inhibitor (PDE5i) (sildenafil, tadalafil or vardenafil) prescription between January 1, 1999 and June 30, 2008, as identified from the United Kingdom - The Health Improvement Network (UK-THIN) database (target population).
879072|NCT01150760|B2|Baseline|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879073|NCT01150760|B1|Baseline|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879074|NCT01150760|P2|Participant Flow|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879075|NCT01150760|P1|Participant Flow|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879076|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879077|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879078|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879079|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879080|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879081|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879082|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879083|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879084|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879085|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879086|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879087|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879088|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879089|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879090|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879091|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879092|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879093|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879094|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879095|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879096|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879097|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879098|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879099|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879100|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879101|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879102|NCT01150760|O2|Outcome|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879103|NCT01150760|O1|Outcome|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879104|NCT01150760|E2|Reported Event|Matched Controls|Each alvimopan patient was exact-matched (surgical procedure, surgeon specialty) and propensity score-matched (baseline characteristics) to a bowel resection patient who did not receive alvimopan
879105|NCT01150760|E1|Reported Event|Alvimopan Users|Oral alvimopan 12 mg (dosing recommendation = once preoperatively then twice daily postoperatively for up to 15 in-hospital doses)
879106|NCT01150500|B1|Baseline|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879107|NCT01150500|P1|Participant Flow|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879108|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879109|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879110|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879111|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879112|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879113|NCT01150500|O1|Outcome|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879114|NCT01150500|E1|Reported Event|Stent Placement|"Up to two lesions in two separate target vessels may be treated under this protocol. The lesions should be amenable to treatment with at least one 2.25 mm stent, a second lesion could be treated with any stent from 2.25 to 3.5 mm.~MDT-4107 Zotarolimus-Eluting Coronary Stent : Implantation of a MDT-4107 Zotarolimus-Eluting Coronary Stent"
879115|NCT01150474|B3|Baseline|Total|Total of all reporting groups
879116|NCT01150474|B2|Baseline|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879117|NCT01150474|B1|Baseline|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879118|NCT01150474|P2|Participant Flow|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879119|NCT01150474|P1|Participant Flow|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879120|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879121|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879122|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879123|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879124|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879125|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879126|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879127|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879128|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879129|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879130|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879131|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879132|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879133|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879134|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879135|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879136|NCT01150474|O2|Outcome|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879137|NCT01150474|O1|Outcome|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879138|NCT01150474|E2|Reported Event|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879139|NCT01150474|E1|Reported Event|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
879140|NCT01150461|B3|Baseline|Total|Total of all reporting groups
879141|NCT01150461|B2|Baseline|Placebo|
879142|NCT01150461|B1|Baseline|Losartan 50 mg PO BID|
879143|NCT01150461|P2|Participant Flow|Placebo|
879144|NCT01150461|P1|Participant Flow|Losartan 50 mg BID|
879145|NCT01150461|O2|Outcome|Placebo|
879146|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
879147|NCT01150461|O2|Outcome|Placebo|
879148|NCT01150461|O1|Outcome|Losartan 50 mg PO BID|
879149|NCT01150461|E2|Reported Event|Placebo|
879150|NCT01150461|E1|Reported Event|Losartan 50 PO mg BID|
879151|NCT01150409|B3|Baseline|Total|Total of all reporting groups
879152|NCT01150409|B2|Baseline|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879153|NCT01150409|B1|Baseline|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879154|NCT01150409|P2|Participant Flow|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879155|NCT01150409|P1|Participant Flow|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879156|NCT01150409|O2|Outcome|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879157|NCT01150409|O1|Outcome|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879158|NCT01150409|E2|Reported Event|Normal Saline (Placebo)|"0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879159|NCT01150409|E1|Reported Event|Hydrocortisone|"Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~hydrocortisone: 1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)~Normal Saline: 0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)"
879160|NCT01150357|B4|Baseline|Total|Total of all reporting groups
879161|NCT01150357|B3|Baseline|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879162|NCT01150357|B2|Baseline|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879183|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879163|NCT01150357|B1|Baseline|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight greater than or equal to (≥) 20 kilogram (kg) to less than (< ) 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and less than or equal to (≤)150 kg received 25 mg of aliskiren.
879164|NCT01150357|P3|Participant Flow|Aliskiren High (150/300/600 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 52 participants switched to placebo treatment."
879165|NCT01150357|P2|Participant Flow|Aliskiren Mid (37.5/75/150 mg)|"During Phase 1: Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.~During Phase 2: 30 participants continued the aliskiren treatment from Phase 1, while 21 participants switched to placebo treatment."
879166|NCT01150357|P1|Participant Flow|Aliskiren Low (6.25/12.5/25 mg)|"During Phase 1: Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.~During Phase 2: 50 participants continued the aliskiren treatment from Phase 1, while 57 participants switched to placebo treatment."
879167|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879168|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879169|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879170|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879171|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879172|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879173|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879174|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879175|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879176|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879177|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879178|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879179|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879180|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879181|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879182|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
879184|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
879185|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879186|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
879187|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879188|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879189|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879190|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879191|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
879192|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879193|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
879194|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879195|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
879196|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879197|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879198|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879199|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879200|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
879201|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879202|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
879203|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879204|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
879205|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879206|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879207|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879208|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879209|NCT01150357|O6|Outcome|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
879240|NCT01150123|B6|Baseline|5μg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
880507|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
879210|NCT01150357|O5|Outcome|Phase 2: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879211|NCT01150357|O4|Outcome|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules (37.5/75/150 mg) once daily.
879212|NCT01150357|O3|Outcome|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879213|NCT01150357|O2|Outcome|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
879214|NCT01150357|O1|Outcome|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received body­weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879215|NCT01150357|O3|Outcome|Phase 1: Aliskiren High (150/300/600 mg)|Participants received body­weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879216|NCT01150357|O2|Outcome|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received body­weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879217|NCT01150357|O1|Outcome|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879218|NCT01150357|E9|Reported Event|Phase 2: Placebo High|Participants received placebo capsules matching to aliskiren capsules (150/300/600 mg) once daily.
879219|NCT01150357|E8|Reported Event|Phase 2: Placebo Mid|Participants received placebo capsules matching to aliskiren capsules(37.5/75/150 mg) once daily.
879220|NCT01150357|E7|Reported Event|Phase 2: Placebo Low|Participants received placebo capsules matching to aliskiren capsules (6.25/12.5/25 mg) once daily.
879221|NCT01150357|E6|Reported Event|Phase 2: Aliskiren High (150/300/600 mg)|"Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and~≤ 150 kg received 600 mg of aliskiren."
879222|NCT01150357|E5|Reported Event|Phase 2: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879223|NCT01150357|E4|Reported Event|Phase 2: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879224|NCT01150357|E3|Reported Event|Phase 1: Aliskiren High (150/300/600 mg)|Participants received bodyweight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren.
879225|NCT01150357|E2|Reported Event|Phase 1: Aliskiren Mid (37.5/75/150 mg)|Participants received bodyweight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren.
879226|NCT01150357|E1|Reported Event|Phase 1: Aliskiren Low (6.25/12.5/25 mg)|Participants received bodyweight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren.
879227|NCT01150123|B19|Baseline|Total|Total of all reporting groups
879228|NCT01150123|B18|Baseline|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879229|NCT01150123|B17|Baseline|20 μg-2 Inj-MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879230|NCT01150123|B16|Baseline|20 μg-1 Inj –MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879231|NCT01150123|B15|Baseline|5μg-2 Inj –MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879232|NCT01150123|B14|Baseline|5μg-1 Inj –MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879233|NCT01150123|B13|Baseline|20 μg-2 Inj –MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879234|NCT01150123|B12|Baseline|20 μg-1 Inj –MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879235|NCT01150123|B11|Baseline|5μg-2 Inj –MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879236|NCT01150123|B10|Baseline|5μg-1 Inj –MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879237|NCT01150123|B9|Baseline|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart t
879238|NCT01150123|B8|Baseline|20 μg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879239|NCT01150123|B7|Baseline|20 μg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879442|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
879241|NCT01150123|B5|Baseline|5μg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879242|NCT01150123|B4|Baseline|20 μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879243|NCT01150123|B3|Baseline|20 μg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879244|NCT01150123|B2|Baseline|5μg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879245|NCT01150123|B1|Baseline|5μg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879246|NCT01150123|P18|Participant Flow|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879247|NCT01150123|P17|Participant Flow|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879248|NCT01150123|P16|Participant Flow|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879249|NCT01150123|P15|Participant Flow|5 µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879250|NCT01150123|P14|Participant Flow|5 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879251|NCT01150123|P13|Participant Flow|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879252|NCT01150123|P12|Participant Flow|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879253|NCT01150123|P11|Participant Flow|5 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879254|NCT01150123|P10|Participant Flow|5 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879255|NCT01150123|P9|Participant Flow|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879256|NCT01150123|P8|Participant Flow|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879257|NCT01150123|P7|Participant Flow|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879258|NCT01150123|P6|Participant Flow|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879259|NCT01150123|P5|Participant Flow|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879260|NCT01150123|P4|Participant Flow|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879261|NCT01150123|P3|Participant Flow|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879262|NCT01150123|P2|Participant Flow|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879263|NCT01150123|P1|Participant Flow|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879264|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879265|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879266|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879267|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879268|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879269|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879270|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879271|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879272|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879273|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879274|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879275|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879276|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879277|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879278|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879279|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879707|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879280|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879281|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879282|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879283|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879284|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879285|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879286|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879287|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879288|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879289|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879290|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879291|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879292|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879293|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879294|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879295|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879296|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879297|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879298|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879299|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879300|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879301|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879302|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879303|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879304|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879305|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879306|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879307|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879308|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879309|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879310|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879311|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879312|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879313|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879314|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879315|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879316|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879317|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879318|NCT01150123|O9|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879319|NCT01150123|O8|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
880508|NCT01147406|O2|Outcome|Cohort 2 and 4|N6022 - Active 15 mg
879320|NCT01150123|O7|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879321|NCT01150123|O6|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879322|NCT01150123|O5|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879323|NCT01150123|O4|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879324|NCT01150123|O3|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879325|NCT01150123|O2|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879326|NCT01150123|O1|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879327|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879328|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879329|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879330|NCT01150123|O15|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879331|NCT01150123|O14|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879332|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879333|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879334|NCT01150123|O11|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879335|NCT01150123|O10|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879336|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879337|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879338|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879339|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879340|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879341|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879342|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879343|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879344|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879345|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879346|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879347|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879348|NCT01150123|O15|Outcome|5 µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879349|NCT01150123|O14|Outcome|5 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879350|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879351|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879352|NCT01150123|O11|Outcome|5 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879353|NCT01150123|O10|Outcome|5 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879354|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879355|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879356|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879357|NCT01150123|O6|Outcome|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879358|NCT01150123|O5|Outcome|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879359|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879360|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879361|NCT01150123|O2|Outcome|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879362|NCT01150123|O1|Outcome|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879363|NCT01150123|O18|Outcome|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879364|NCT01150123|O17|Outcome|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879365|NCT01150123|O16|Outcome|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879366|NCT01150123|O15|Outcome|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879367|NCT01150123|O14|Outcome|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879368|NCT01150123|O13|Outcome|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879369|NCT01150123|O12|Outcome|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879370|NCT01150123|O11|Outcome|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879371|NCT01150123|O10|Outcome|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879372|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879373|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879374|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879375|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879376|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879377|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879378|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879379|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879380|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879381|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879382|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879383|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879384|NCT01150123|O6|Outcome|5 µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879385|NCT01150123|O5|Outcome|5 µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879386|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879387|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879388|NCT01150123|O2|Outcome|5 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879389|NCT01150123|O1|Outcome|5 µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879390|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879391|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879392|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879393|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879394|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879395|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879396|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879397|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879398|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879399|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879400|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
880509|NCT01147406|O1|Outcome|Cohort 1|N6022 - Active 5 mg
879401|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879402|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879403|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879404|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879405|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879406|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879407|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879408|NCT01150123|O9|Outcome|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879409|NCT01150123|O8|Outcome|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879410|NCT01150123|O7|Outcome|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879411|NCT01150123|O6|Outcome|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879412|NCT01150123|O5|Outcome|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879413|NCT01150123|O4|Outcome|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879414|NCT01150123|O3|Outcome|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879415|NCT01150123|O2|Outcome|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879416|NCT01150123|O1|Outcome|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879417|NCT01150123|E18|Reported Event|Placebo – Group 2|Subjects received two injections of placebo administered 1 month apart
879418|NCT01150123|E17|Reported Event|20 µg-2 Inj- MF59_F|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879419|NCT01150123|E16|Reported Event|20 µg-1 Inj – MF59_F|Subjects received single active vaccine injection (20 µg) adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879420|NCT01150123|E15|Reported Event|5µg-2 Inj – MF59_F|Subjects received two identical active vaccine injections (5 µg) adjuvanted with 9.75 mg of MF59 administered 1 month apart
879421|NCT01150123|E14|Reported Event|5µg-1 Inj – MF59_F|Subjects received single active vaccine injection (5 µg) of adjuvanted with 9.75 mg of MF59 followed by a placebo administered 1 month apart
879422|NCT01150123|E13|Reported Event|20 µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (20 µg) adjuvanted with 4.87 mg of MF59 administered 1 month apart
879423|NCT01150123|E12|Reported Event|20 µg-1 Inj – MF59_H|Subjects received single active vaccine injection (20 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879424|NCT01150123|E11|Reported Event|5µg-2 Inj – MF59_H|Subjects received two identical active vaccine injections (5 µg) of adjuvanted with 4.87 mg of MF59 administered 1 month apart
879425|NCT01150123|E10|Reported Event|5µg-1 Inj – MF59_H|Subjects received single active vaccine injection (5 µg) adjuvanted with 4.87 mg of MF59 followed by a placebo administered 1 month apart
879426|NCT01150123|E9|Reported Event|Placebo - Group 1|Subjects received two injections of placebo administered 1 month apart
879427|NCT01150123|E8|Reported Event|20 µg-2 Inj- Alum|Subjects received two identical active vaccine injections (20 µg) with adjuvant administered 1 month apart
879428|NCT01150123|E7|Reported Event|20 µg-1 Inj - Alum|Subjects received single active vaccine injection (20 µg) with adjuvant followed by a placebo administered 1 month apart
879429|NCT01150123|E6|Reported Event|5µg-2 Inj - Alum|Subjects received two identical active vaccine injections (5 µg) with adjuvant administered 1 month apart
879430|NCT01150123|E5|Reported Event|5µg-1 Inj - Alum|Subjects received single active vaccine injection (5 µg) with adjuvant followed by a placebo administered 1 month apart
879431|NCT01150123|E4|Reported Event|20 µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (20 µg) without any adjuvant administered 1 month apart
879432|NCT01150123|E3|Reported Event|20 µg-1 Inj - No Adj|Subjects received single active vaccine injection (20 µg) without any adjuvant followed by a placebo administered 1 month apart
879433|NCT01150123|E2|Reported Event|5µg-2 Inj - No Adj|Subjects received two identical active vaccine injections (5 µg) without any adjuvant administered 1 month apart
879434|NCT01150123|E1|Reported Event|5µg-1 Inj - No Adj|Subjects received single active vaccine injection (5 µg) without any adjuvant followed by a placebo administered 1 month apart
879435|NCT01150097|B4|Baseline|Total|Total of all reporting groups
879436|NCT01150097|B3|Baseline|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
879437|NCT01150097|B2|Baseline|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879438|NCT01150097|B1|Baseline|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879439|NCT01150097|P3|Participant Flow|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
879440|NCT01150097|P2|Participant Flow|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879441|NCT01150097|P1|Participant Flow|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879443|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879444|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879445|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
879446|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879447|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879448|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879449|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879450|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
879451|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879452|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879453|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879454|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879455|NCT01150097|O3|Outcome|Tacrolimus Control|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL tacrolimus.
879456|NCT01150097|O2|Outcome|Tacrolimus Elimination|Participants were maintained on a whole blood trough level of 6 - 10 ng/mL everolimus.
879457|NCT01150097|O1|Outcome|Everolimus + Reduced Tacrolimus|Participants were maintained on whole blood trough levels of 3 - 8 ng/mL everolimus and 3 - 5 ng/mL tacrolimus.
879458|NCT01150097|E5|Reported Event|TAC Elimination, Month 48|TAC Elimination, Month 48
879459|NCT01150097|E4|Reported Event|Reduced RAD + TAC, Month 48|Reduced RAD + TAC, Month 48
879460|NCT01150097|E3|Reported Event|TAC Control, Month 36|TAC Control, Month 36
879461|NCT01150097|E2|Reported Event|TAC Elimination, Month 36|TAC Elimination, Month 36
879462|NCT01150097|E1|Reported Event|Reduced TAC, Month 36|Reduced TAC, Month 36
879463|NCT01149876|B5|Baseline|Total|Total of all reporting groups
879464|NCT01149876|B4|Baseline|Proprietary Topical Plus Iontophoresis|
879465|NCT01149876|B3|Baseline|Tretinoin|
879466|NCT01149876|B2|Baseline|Placebo|
879467|NCT01149876|B1|Baseline|Proprietary Topical|
879468|NCT01149876|P4|Participant Flow|Nu Skin Product With Galvanic Spa System|
879469|NCT01149876|P3|Participant Flow|Tretinoin Cream 0.05|
879470|NCT01149876|P2|Participant Flow|Over the Counter Moisturizer|CeraVe Moisturizer
879471|NCT01149876|P1|Participant Flow|Nu Skin Product|
879472|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
879473|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
879474|NCT01149876|O2|Outcome|Over the Counter Moisturizer|
879475|NCT01149876|O1|Outcome|Nu Skin Product|
879476|NCT01149876|O4|Outcome|Nu Skin Product With Galvanic Spa System|
879477|NCT01149876|O3|Outcome|Tretinoin Cream 0.05|
879478|NCT01149876|O2|Outcome|Over the Counter Moisturizer|CeraVe cream
879479|NCT01149876|O1|Outcome|Nu Skin Product|
879480|NCT01149876|E4|Reported Event|Proprietary Topical Plus Iontophoresis|
879481|NCT01149876|E3|Reported Event|Tretinoin|
879482|NCT01149876|E2|Reported Event|Placebo|
879483|NCT01149876|E1|Reported Event|Proprietary Topical|
879484|NCT01149863|B1|Baseline|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
879485|NCT01149863|P1|Participant Flow|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
879486|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
879487|NCT01149863|O1|Outcome|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
879488|NCT01149863|E1|Reported Event|Plerixafor 17 Hours Prior to Apheresis|"Dosing of plerixafor will occur at 3PM (1500 hours).~Plerixafor : Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses."
879489|NCT01149785|B1|Baseline|Entire Study Population|Includes participants randomized to receive Crizotinib 150 mg IRT first and then Crizotinib 150 mg + Ketoconazole 200 mg BID
879490|NCT01149785|P2|Participant Flow|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet twice daily (BID), orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period. A washout period of at least 14 days was maintained between each period.
879491|NCT01149785|P1|Participant Flow|Crizotinib 150 mg|Single oral dose of crizotinib 150 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
879492|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879493|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
880510|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
879494|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879495|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879496|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879497|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879498|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879499|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879500|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879501|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879502|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879503|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879504|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879505|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879506|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879507|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879508|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879509|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879510|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879511|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879512|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879513|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879514|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879515|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879516|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879517|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879518|NCT01149785|O2|Outcome|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879519|NCT01149785|O1|Outcome|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879520|NCT01149785|E2|Reported Event|Crizotinib 150 mg + Ketoconazole 200 mg BID|Ketoconazole 200 mg tablet BID, orally in fasted state from Day 1 to Day 16 and single oral dose of crizotinib 150 mg IRT on Day 4 in second intervention period [Treatment B (Test)].
879521|NCT01149785|E1|Reported Event|Crizotinib 150 mg|Single oral dose of crizotinib 150 mg IRT in first intervention period [Treatment A (Reference)].
879522|NCT01149772|B3|Baseline|Total|Total of all reporting groups
879523|NCT01149772|B2|Baseline|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
879524|NCT01149772|B1|Baseline|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. After completion of the active treatment sessions, the participant will receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made. Each active treatment session lasts 30 - 40 minutes and the booster calls last 10 - 15 minute.
879525|NCT01149772|P2|Participant Flow|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
879888|NCT01148537|O1|Outcome|Mofloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
879526|NCT01149772|P1|Participant Flow|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
879527|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
879528|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
879529|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
879530|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
879531|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
879532|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
879533|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
879534|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls. The follow up calls provide the opportunity for the participant to review skills learned, address any questions or difficulties, and reinforce changes made.
879535|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
879536|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
879537|NCT01149772|O2|Outcome|Enhanced Usual Care|Patients in this arm receive feedback about their physical and emotional health functioning and subsequently receive usual primary care services.
879538|NCT01149772|O1|Outcome|ACCESS|Adjusting to Chronic Conditions Using Education, Support, and Skills: Participants in this condition will receive 6 active weekly treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant will be able to choose elective modules from Managing your Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Learning How to Relax. Participants are required to complete the first session in person Subsequent sessions participants have the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
879539|NCT01149772|E2|Reported Event|Enhanced Usual Care|Patients in this arm received feedback about their physical and emotional health functioning and were still able to receive usual primary care services.
879889|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879540|NCT01149772|E1|Reported Event|ACCESS|ACCESS: Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completing core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. After completion of the active treatment sessions, the participant can receive 2 brief follow-up booster calls to aid in reinforcing the skills learned.
879541|NCT01149759|B1|Baseline|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
879542|NCT01149759|P1|Participant Flow|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
879543|NCT01149759|O1|Outcome|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
879544|NCT01149759|O1|Outcome|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
879545|NCT01149759|E1|Reported Event|Cyclosporine A|"5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks.~Cyclosporine A: 5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks"
879546|NCT01149733|B3|Baseline|Total|Total of all reporting groups
879547|NCT01149733|B2|Baseline|Flomax®|0.4 mg Capsule
879548|NCT01149733|B1|Baseline|Tamsulosin|0.4 mg Capsule
879549|NCT01149733|P2|Participant Flow|Flomax®|0.4 mg Capsule
879550|NCT01149733|P1|Participant Flow|Tamsulosin|0.4 mg Capsule
879551|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
879552|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
879553|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
879554|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
879555|NCT01149733|O2|Outcome|Flomax®|0.4 mg Capsule
879556|NCT01149733|O1|Outcome|Tamsulosin|0.4 mg Capsule
879557|NCT01149733|E2|Reported Event|Flomax®|0.4 mg Capsule
879558|NCT01149733|E1|Reported Event|Tamsulosin|0.4 mg Capsule
879559|NCT01149655|B3|Baseline|Total|Total of all reporting groups
879560|NCT01149655|B2|Baseline|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879561|NCT01149655|B1|Baseline|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879562|NCT01149655|P4|Participant Flow|Aripiprazole-Placebo-DB Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
879563|NCT01149655|P3|Participant Flow|Aripiprazole-Double Blind (DB) Maintenance|Participants who met stability criteria in period 2 (stabilization phase) received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
879564|NCT01149655|P2|Participant Flow|Aripiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
879565|NCT01149655|P1|Participant Flow|Aripiprazole-Conversion Phase|Participants who had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
879566|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879567|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879568|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879569|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879570|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879571|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879572|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879573|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879574|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879575|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879576|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879577|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879578|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879579|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879580|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879581|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879582|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879583|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879584|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879585|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879586|NCT01149655|O2|Outcome|Placebo-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received placebo as double-blind maintenance treatment for up to 52 weeks.
879587|NCT01149655|O1|Outcome|Aripiprazole-Double Blind Maintenance|Participants in period 3 were randomized in a 2:1 (aripiprazole: placebo) ratio and had received oral aripiprazole in the range of 10 to 30 mg/day as double-blind maintenance treatment for up to 52 weeks.
879588|NCT01149655|E4|Reported Event|Placebo-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received placebo for 52 Weeks in period 3 (double-blind maintenance treatment).
879589|NCT01149655|E3|Reported Event|Aripiprazole-Double Blind Maintenance Treatment|Participants who met stability criteria in period 2 (stabilization phase) had received oral aripiprazole 10 to 30 mg/day for 52 Weeks in period 3 (double-blind maintenance treatment).
879590|NCT01149655|E2|Reported Event|Arpiprazole-Stabilization Phase|Participants who had converted to aripiprazole monotherapy period 1 (conversion phase) and had received aripiprazole monotherapy for schizophrenia at screening were in period 2, provided the prescribed aripiprazole dose did not exceed 30 mg (milligrams) per day for 2 Weeks.
879591|NCT01149655|E1|Reported Event|Aripiprazole-Conversion Phase|Participants had received oral aripiprazole 2 to 10 mg for 2 Weeks in combination with any other antipsychotic were in conversion phase.
879592|NCT01149538|B3|Baseline|Total|Total of all reporting groups
879593|NCT01149538|B2|Baseline|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879594|NCT01149538|B1|Baseline|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879595|NCT01149538|P2|Participant Flow|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879596|NCT01149538|P1|Participant Flow|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879597|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879598|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879599|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879600|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879601|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879602|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879603|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879604|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879605|NCT01149538|O2|Outcome|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879606|NCT01149538|O1|Outcome|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879607|NCT01149538|E2|Reported Event|Placebo|"Placebo for choline bitartrate supplementation~Placebo for choline bitartrate: Placebo for choline bitartrate, administered daily in fruit-flavored drink mix."
879890|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
879608|NCT01149538|E1|Reported Event|Choline Bitartrate|"Choline Bitartrate supplementation~Choline bitartrate: Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix."
879609|NCT01149486|B3|Baseline|Total|Total of all reporting groups
879610|NCT01149486|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
879611|NCT01149486|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
879612|NCT01149486|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in the second period.
879613|NCT01149486|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
879614|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879615|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879616|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879617|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879618|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879619|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879620|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879621|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879622|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879623|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879624|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879625|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879626|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879627|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879628|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879629|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879630|NCT01149486|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879631|NCT01149486|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879632|NCT01149486|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879633|NCT01149486|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide Tablets test product dosed in either period.
879634|NCT01149473|B3|Baseline|Total|Total of all reporting groups
879635|NCT01149473|B2|Baseline|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
879636|NCT01149473|B1|Baseline|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
879637|NCT01149473|P2|Participant Flow|Hyzaar® (Reference) First|100/25 mg Hyzaar® Tablets reference product dosed in first period followed by 100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in the second period.
879638|NCT01149473|P1|Participant Flow|Losartan/HCTZ (Test) First|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in first period followed by 100/25 mg Hyzaar® Tablets reference product dosed in the second period.
879639|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879640|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
879641|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879642|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
879643|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879644|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
879645|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879646|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
879647|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879648|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
879649|NCT01149473|O2|Outcome|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879650|NCT01149473|O1|Outcome|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
879651|NCT01149473|E2|Reported Event|Hyzaar® (Reference)|100/25 mg Hyzaar® Tablets reference product dosed in either period.
879652|NCT01149473|E1|Reported Event|Losartan/HCTZ (Test)|100/25 mg Losartan potassium/Hydrochlorothiazide test product dosed in either period.
879653|NCT01149460|B3|Baseline|Total|Total of all reporting groups
880511|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
879654|NCT01149460|B2|Baseline|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879655|NCT01149460|B1|Baseline|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879656|NCT01149460|P2|Participant Flow|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879657|NCT01149460|P1|Participant Flow|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879658|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879659|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879660|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879661|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879662|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879663|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879664|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879665|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879666|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879667|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879668|NCT01149460|O2|Outcome|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879669|NCT01149460|O1|Outcome|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879670|NCT01149460|E2|Reported Event|Valtrex®|Reference Listed Valtrex® 1000 mg Tablet dosed in first period followed by Test 1000 mg Valacyclovir tablet in second period
879671|NCT01149460|E1|Reported Event|Valacyclovir|Test 1000 mg Tablet dosed in first period follwed by Reference Listed 1000 mg Valtrex® tablet in second period
879672|NCT01149434|B3|Baseline|Total|Total of all reporting groups
879673|NCT01149434|B2|Baseline|Pharmacokinetic Arm-Phase II|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
879674|NCT01149434|B1|Baseline|Pharmacokinetic Arm - Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus."
879675|NCT01149434|P2|Participant Flow|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
879676|NCT01149434|P1|Participant Flow|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
879677|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
879678|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
879679|NCT01149434|O1|Outcome|Pharmacodynamic Arm Phase 2|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
879708|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879709|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879710|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879680|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
879681|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
879682|NCT01149434|O1|Outcome|Pharmacokinetic Arm Phase 1|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
879683|NCT01149434|O1|Outcome|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
879684|NCT01149434|E2|Reported Event|Pharmacodynamic Arm|"Patients going on the Pharmacodynamic study will receive JI-101 only.~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis."
879685|NCT01149434|E1|Reported Event|Pharmacokinetic Arm|"Patients going on Pharmacokinetic arm will receive JI-101 & Everolimus (4 patients only)~JI-101: JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.~Everolimus: Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1)."
879686|NCT01149421|B4|Baseline|Total|Total of all reporting groups
879687|NCT01149421|B3|Baseline|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879688|NCT01149421|B2|Baseline|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879689|NCT01149421|B1|Baseline|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879690|NCT01149421|P3|Participant Flow|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879691|NCT01149421|P2|Participant Flow|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879692|NCT01149421|P1|Participant Flow|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879693|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879694|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879695|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879696|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879697|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879698|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879699|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879700|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879701|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879702|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879703|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879704|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879705|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879706|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879711|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879712|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879713|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879714|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879715|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879716|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879717|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879718|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879719|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879720|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879721|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879722|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879723|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879724|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879725|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879726|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879727|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879728|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879729|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879730|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879731|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879732|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879733|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879734|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879735|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879736|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879737|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879738|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879739|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879740|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879741|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879742|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879743|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879744|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879745|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879746|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879747|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879748|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879749|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879750|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879751|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879752|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879753|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879754|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879755|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879756|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879757|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879758|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879759|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879760|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879761|NCT01149421|O3|Outcome|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879762|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879763|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879765|NCT01149421|O2|Outcome|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879766|NCT01149421|O1|Outcome|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879767|NCT01149421|E3|Reported Event|Placebo|Placebo: subcutaneous (SC), once weekly (QW) for 26 weeks
879768|NCT01149421|E2|Reported Event|0.75 Milligram (mg) LY2189265|LY2189265: 0.75 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879769|NCT01149421|E1|Reported Event|1.5 Milligram (mg) LY2189265|LY2189265: 1.5 milligram (mg), subcutaneous (SC), once weekly (QW) for 26 weeks
879770|NCT01149148|B3|Baseline|Total|Total of all reporting groups
879771|NCT01149148|B2|Baseline|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
879772|NCT01149148|B1|Baseline|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
879773|NCT01149148|P2|Participant Flow|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
879774|NCT01149148|P1|Participant Flow|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
879775|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
879776|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|At the start of surgery two sensor pads will be placed on the patients forehead and attached to the INVOS Monitoring System. If the rSO2 values decrease >20% from baseline or decline below 50 the anesthesiologist will initiate an intervention: Increase mean arterial pressure, check head and cannula position, increase pump flow, increase systemic oxygenation, increase PaCo2 >45, increase anesthetic depth by increaseing volatile anesthetic or administering propoful boluses, consider PRBC transfusion for Hct<21%.
879777|NCT01149148|O2|Outcome|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
879778|NCT01149148|O1|Outcome|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
879779|NCT01149148|E2|Reported Event|Standard of Care|Blinded cerebral oximetry monitoring with no intervention in surgical procedures and anesthesia without deviation from standard of care.
879780|NCT01149148|E1|Reported Event|Intervention INVOS Cerebral Oximetry Monitoring|> 20% drop rSO2 from baseline or declines in rSO2 < 50%
879781|NCT01149057|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879782|NCT01149057|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilograms (mg/kg) intravenous (IV) infusion every 4 weeks for a period of 96 weeks.
879783|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879784|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879785|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879786|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879787|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879788|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879789|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879790|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879791|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879792|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879793|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879794|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879795|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879796|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879797|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879798|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879799|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879800|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879801|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879802|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879803|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879804|NCT01149057|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879805|NCT01149057|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV infusion every 4 weeks for a period of 96 weeks.
879806|NCT01148979|B3|Baseline|Total|Total of all reporting groups
879807|NCT01148979|B2|Baseline|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
879808|NCT01148979|B1|Baseline|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
879809|NCT01148979|P2|Participant Flow|Vyvanse, Then Placebo|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
879810|NCT01148979|P1|Participant Flow|Placebo, Then Vyvanse|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
879811|NCT01148979|O2|Outcome|Lisdexamfetamine Dimesylate (Vyvanse)|"Participants first received Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule each morning for 4 weeks, staring with initial dose 30 mg/d. After a washout period of 2 weeks, they then received Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
879812|NCT01148979|O1|Outcome|Placebo Adjunct|"Participants first received Placebo capsule (matching Lisdexamfetamine Dimesylate(Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they then received Lisdexamfetamine Dimesylate (Vyvanse) capsule each morning for 4 weeks, starting with initial dose 30 mg/d.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
879813|NCT01148979|E2|Reported Event|Adjunct Placebo|"Participants receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) 20-50 mg capsule) each morning for 4 weeks. After a washout period of 2 weeks, they receive Lisdexamfetamine Dimesylate capsule each morning for 4 weeks.~Placebo: Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules."
879814|NCT01148979|E1|Reported Event|Adjunct Lisdexamfetamine (Vyvanse)|"Participants receive Lisdexamfetamine Dimesylate 20-50 mg capsule each morning for 4 weeks. After a washout period of 2 weeks, they receive Placebo capsule (matching Lisdexamfetamine Dimesylate (Vyvanse) capsule) each morning for 4 weeks.~Lisdexamfetamine Dimesylate (Vyvanse): Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg."
879815|NCT01148862|B1|Baseline|Entire Study Population|Includes groups randomized to LGS on first and LGS off first
879816|NCT01148862|P2|Participant Flow|LGS Off First, Then LGS on|LGS off first, then LGS on group will wear the MiniMed Paradigm® X54 System with Low Glucose Suspend (LGS) turned 'OFF' first, then LGS turned on 'ON' after crossing over
879817|NCT01148862|P1|Participant Flow|LGS on First, Then LGS Off|LGS on first, then LGS off group will wear the MiniMed Paradigm® X54 System with the Low Glucose Suspend (LGS) feature turned 'ON' first, then LGS turned 'OFF' after crossing over
879818|NCT01148862|O2|Outcome|LGS Off: Without Low Glucose Suspend (LGS) Feature|LGS off: Without Low Glucose Suspend (LGS) feature
879819|NCT01148862|O1|Outcome|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
879820|NCT01148862|O2|Outcome|LGS Off: Without Low Glucose Suspend (LGS) Feature|LGS off: Without Low Glucose Suspend (LGS) feature
879821|NCT01148862|O1|Outcome|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|LGS on: Low Glucose Suspend (LGS) feature turned 'ON'
879822|NCT01148862|E2|Reported Event|LGS on: Low Glucose Suspend (LGS) Feature Turned 'ON'|
879823|NCT01148862|E1|Reported Event|LGS Off: Without Low Glucose Suspend (LGS) Feature|
879824|NCT01148836|B3|Baseline|Total|Total of all reporting groups
879825|NCT01148836|B2|Baseline|Pulmonary Hypertension Subjects|
879826|NCT01148836|B1|Baseline|Healthy Controls Subjects|
879827|NCT01148836|P2|Participant Flow|Pulmonary Hypertension Subjects (Disease)|
879828|NCT01148836|P1|Participant Flow|Healthy Controls|
879829|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
879830|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879831|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
879832|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879833|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
879834|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879835|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
879836|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879837|NCT01148836|O2|Outcome|Normal Controls|Normal controls taking Co-Q for three months
879838|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879839|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879840|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879841|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879842|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879843|NCT01148836|O1|Outcome|Pulmonary Hypertension Subjects|Pulmonary Hypertension subjects taking Co-Q for three months
879844|NCT01148836|E2|Reported Event|Coenzyme Q and Healthy Controls|Healthy Control subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
879891|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879845|NCT01148836|E1|Reported Event|Coenzyme Q and Pulmonary Hypertension|Pulmonary Hypertension subjects Nutritional Supplement Coenzyme Q-10: Nutritional Supplement
879846|NCT01148771|B3|Baseline|Total|Total of all reporting groups
879847|NCT01148771|B2|Baseline|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
879848|NCT01148771|B1|Baseline|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
879849|NCT01148771|P2|Participant Flow|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
879850|NCT01148771|P1|Participant Flow|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
879851|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
879852|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
879853|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 30 minute IV infusion.
879854|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|This is a simulated population of 5000 patients receiving ertapenem 1 gram every 24 hours as a 5 minute IV bolus.
879855|NCT01148771|O2|Outcome|Ertapenem IV 30 Minute Infusion|
879856|NCT01148771|O1|Outcome|Ertapenem IV 5 Minute Bolus|
879857|NCT01148771|O2|Outcome|Ertapenem 1 Gram IV 30 Minute Infusion|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses.
879858|NCT01148771|O1|Outcome|Ertapenem 1 Gram IV 5 Minute Bolus|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
879859|NCT01148771|E2|Reported Event|Ertapenem IV 30 Minute Infusion First, Then 5 Minute Bolus|Participants received ertapenem 1 gram as a 30 minute infusion every 24 hours for 3 doses. After a 4 day washout, participants crossed over to receive ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses.
879860|NCT01148771|E1|Reported Event|Ertapenem IV 5 Minute Bolus First, Then 30 Minute Infusion|Participants received ertapenem 1 gram as a 5 minute IV bolus every 24 hours for 3 doses. After a 4 day washout, participants were crossed over to receive ertapenem 1 gram as a 30 minute IV infusion every 24 hours for 3 doses.
879861|NCT01148745|B1|Baseline|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
879862|NCT01148745|P1|Participant Flow|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
879863|NCT01148745|O1|Outcome|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
879864|NCT01148745|O1|Outcome|Ferumoxytol 510 mg|2 doses of 510 mg IV over 17 seconds separated by 3 days
879865|NCT01148745|O1|Outcome|Ferumoxytol|All participants received 510 mg IV ferumoxytol at both visits 1 and 2.
879866|NCT01148745|E1|Reported Event|Ferumoxytol|2 doses of 510 mg IV over 17 seconds separated by 3 days
879867|NCT01148693|B3|Baseline|Total|Total of all reporting groups
879868|NCT01148693|B2|Baseline|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
879869|NCT01148693|B1|Baseline|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
879870|NCT01148693|P2|Participant Flow|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
879871|NCT01148693|P1|Participant Flow|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
879872|NCT01148693|O2|Outcome|Placebo|patients for whom distilled water is added to contrast during ERCP
879873|NCT01148693|O1|Outcome|Gentamicin|patients for whom 10m/10cc of gentamicin is added to contrast during ERCP
879874|NCT01148693|E2|Reported Event|Placebo|participitants for whom identical placebo with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
879875|NCT01148693|E1|Reported Event|Gentamicin|participitants for whom gentamicin with a dose of 10mg/10ml was added to contrast media during endoscopic cholangiopancreatography
879876|NCT01148537|B4|Baseline|Total|Total of all reporting groups
879877|NCT01148537|B3|Baseline|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
879878|NCT01148537|B2|Baseline|Placebo|Matching placebo transdermal patches.
879879|NCT01148537|B1|Baseline|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
879880|NCT01148537|P3|Participant Flow|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet (Avelox®) by mouth on days 6 and 13
879881|NCT01148537|P2|Participant Flow|Placebo|Matching placebo transdermal patches.
879882|NCT01148537|P1|Participant Flow|BTDS|"Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h. Randomization was from predose on day 1 to predose on day 14. There were 3 treatment groups: BTDS, placebo, and moxifloxacin as the positive control. The treatment groups between placebo and BTDS were double-blinded. Moxifloxacin treatment was open label to subjects, to the investigator, and the staff at the study site.~BTDS or placebo TDS was applied on day 1 for 3 days (BTDS 5), on day 4 for 3 days (BTDS 10), on day 7 for 3 days (BTDS 20), and on day 10 for 4 days (2 * BTDS 20). On day 6 and day 13, subjects in the positive control group received one 400 mg tablet of moxifloxacin."
879883|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879884|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
879885|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879886|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
879892|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
879893|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879894|NCT01148537|O1|Outcome|Moxifloxacin|Positive Control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
879895|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879896|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
879897|NCT01148537|O2|Outcome|Placebo|Matching placebo transdermal patches.
879898|NCT01148537|O1|Outcome|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
879899|NCT01148537|E3|Reported Event|Moxifloxacin|Positive control: One 400 mg moxifloxacin tablet by mouth on days 6 and 13.
879900|NCT01148537|E2|Reported Event|Placebo|Matching placebo transdermal patches.
879901|NCT01148537|E1|Reported Event|BTDS|Buprenorphine transdermal patches 5, 10, 20, and 2 * 20 mcg/h.
879902|NCT01148524|B10|Baseline|Total|Total of all reporting groups
879903|NCT01148524|B9|Baseline|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
879904|NCT01148524|B8|Baseline|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
879905|NCT01148524|B7|Baseline|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
879906|NCT01148524|B6|Baseline|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
879907|NCT01148524|B5|Baseline|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
879908|NCT01148524|B4|Baseline|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
879909|NCT01148524|B3|Baseline|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
879910|NCT01148524|B2|Baseline|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
879911|NCT01148524|B1|Baseline|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
879912|NCT01148524|P9|Participant Flow|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
879913|NCT01148524|P8|Participant Flow|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
879914|NCT01148524|P7|Participant Flow|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
879915|NCT01148524|P6|Participant Flow|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
879916|NCT01148524|P5|Participant Flow|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
879917|NCT01148524|P4|Participant Flow|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
879918|NCT01148524|P3|Participant Flow|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
879919|NCT01148524|P2|Participant Flow|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
879920|NCT01148524|P1|Participant Flow|rMenB06|Subjects who had received 2 doses each of Recombinant Meningococcal B Vaccine with Outer Membrane Vesicle from the New Zealand Strain (rMenB+OMV-NZ) (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
879921|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
879922|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
879923|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
879924|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
879925|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
879926|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
879927|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
879928|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
879929|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
879930|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
879931|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
879932|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
879933|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
879934|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
879935|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
879936|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
879937|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
879938|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
879939|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
879940|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
879941|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
879942|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
879943|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
879944|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
879945|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
879946|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
879947|NCT01148524|O9|Outcome|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
879948|NCT01148524|O8|Outcome|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
879949|NCT01148524|O7|Outcome|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
879950|NCT01148524|O6|Outcome|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
879951|NCT01148524|O5|Outcome|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
879952|NCT01148524|O4|Outcome|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
879953|NCT01148524|O3|Outcome|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
879954|NCT01148524|O2|Outcome|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
879955|NCT01148524|O1|Outcome|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
879956|NCT01148524|E9|Reported Event|Naive|Age-matched subjects who had never received rMenB+OMV-NZ or other experimental MenB vaccines
879957|NCT01148524|E8|Reported Event|rMenB6|Subjects who had received 1 dose of rMenB+OMV-NZ (at 6 months) and 3 doses of placebo (at 0, 1 and 2 months) in V72P10 study.
879958|NCT01148524|E7|Reported Event|rMenB012|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 2 months) and placebo (at 6 months) in V72P10 study.
879959|NCT01148524|E6|Reported Event|rMenB02|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 2 months) and placebo (at 1 and 6 months) in V72P10 study.
879960|NCT01148524|E5|Reported Event|rMenB026|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 2 and 6 months) and 1 dose of placebo (at 1 month) in V72P10 study.
879961|NCT01148524|E4|Reported Event|rMenB01|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 1 months) and placebo (at 2 and 6 months) in V72P10 study.
879962|NCT01148524|E3|Reported Event|rMenB016|Subjects who had received 3 doses of rMenB+OMV-NZ (at 0, 1 and 6 months) and 1 dose of placebo (at 2 months) in V72P10 study.
879963|NCT01148524|E2|Reported Event|rMenB0|Subjects who had received 1 dose of rMenB+OMV-NZ (at 0 month) and 3 doses of placebo (at 1, 2 and 6 months) in V72P10 study.
879964|NCT01148524|E1|Reported Event|rMenB06|Subjects who had received 2 doses each of rMenB+OMV-NZ (at 0 and 6 months) and placebo (at 1 and 2 months) in V72P10 study.
879965|NCT01148511|B3|Baseline|Total|Total of all reporting groups
879966|NCT01148511|B2|Baseline|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879967|NCT01148511|B1|Baseline|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879968|NCT01148511|P3|Participant Flow|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879969|NCT01148511|P2|Participant Flow|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879970|NCT01148511|P1|Participant Flow|All Patients|All 99 patients were exposed to study drug. 93 of the 99 patients were randomized into the Treat and Extend and the Treat and Observe treatment groups.
879971|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879994|NCT01148056|B1|Baseline|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
880502|NCT01147406|P2|Participant Flow|Cohorts 2 and 4|15 mg of N6022 was given intravenously daily for 7 days
879972|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879973|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879974|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879975|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879976|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879977|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879978|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879979|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879980|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879981|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879982|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879983|NCT01148511|O2|Outcome|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879984|NCT01148511|O1|Outcome|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879985|NCT01148511|E3|Reported Event|Before Randomization|These 6 patients were exposed to study drug but discontinued from the study prior to randomization.
879986|NCT01148511|E2|Reported Event|Treat and Observe|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. All subsequent visits occurred monthly. If the disease was active, the patient received ranibizumab 0.5 mg ivt. If the disease was inactive, no treatment was administered and the patient was instructed to return 1 month later.
879987|NCT01148511|E1|Reported Event|Treat and Extend|Patients received ranibizumab 0.5 mg intravitreally (ivt) once a month for 3 months. If the disease was inactive 4 weeks later, the next visit was postponed 2 weeks to 6 weeks later. If the disease was inactive during subsequent visits, the next visit was postponed an additional 2 weeks to 8 weeks later, the maximum interval between visits. If the disease became active at any visit, the patient received ranibizumab 0.5 mg ivt and the follow-up schedule started over.
879988|NCT01148420|B1|Baseline|DMPA + MPA|
879989|NCT01148420|P1|Participant Flow|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
879990|NCT01148420|O1|Outcome|DMPA + MPA|
879991|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
879992|NCT01148420|O1|Outcome|DMPA + MPA|150 mg intramuscularly received DMPA and two 10 mg tablets of MPA every 8 hours for 3 days.
879993|NCT01148420|E1|Reported Event|DMPA & High Dose MPA|DMPA & High Dose MPA
879995|NCT01148056|P1|Participant Flow|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
879996|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
879997|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
879998|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
879999|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
880000|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
880001|NCT01148056|O1|Outcome|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
880002|NCT01148056|E1|Reported Event|Short Course IMRT|"Pts will receive short course IMRT prior to surgery. Dose will be 5 Gy x 5, followed by surgery the week after~Intensity Modulated Radiation Therapy: Radiation therapy once a day for 5 days"
880003|NCT01148017|B5|Baseline|Total|Total of all reporting groups
880004|NCT01148017|B4|Baseline|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880005|NCT01148017|B3|Baseline|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
880006|NCT01148017|B2|Baseline|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880007|NCT01148017|B1|Baseline|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880008|NCT01148017|P4|Participant Flow|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880009|NCT01148017|P3|Participant Flow|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
880010|NCT01148017|P2|Participant Flow|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880011|NCT01148017|P1|Participant Flow|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880012|NCT01148017|O4|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880013|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
880014|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880015|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880016|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880017|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880018|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880019|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880020|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880021|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880022|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880023|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880024|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880025|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880026|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880027|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880028|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
880029|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880030|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880031|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880032|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880033|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880034|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
880035|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880036|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880037|NCT01148017|O3|Outcome|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880038|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880039|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880040|NCT01148017|O3|Outcome|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
880041|NCT01148017|O2|Outcome|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880042|NCT01148017|O1|Outcome|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880043|NCT01148017|E4|Reported Event|Naïve - 60|Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose of MenACWY-CRM.
880044|NCT01148017|E3|Reported Event|Naïve - 40|Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose of MenACWY-CRM.
880045|NCT01148017|E2|Reported Event|ACWY - 2|Subjects who had previously received 1 or 2 doses of MenACWY-CRM in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.
880046|NCT01148017|E1|Reported Event|ACWY - 4|Subjects who had previously received 4 doses of MenACWY-CRM in the parent study during their first year of life, are administered one booster dose of the same vaccine at 60 months of age.
880047|NCT01147926|B3|Baseline|Total|Total of all reporting groups
880048|NCT01147926|B2|Baseline|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880049|NCT01147926|B1|Baseline|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880050|NCT01147926|P2|Participant Flow|PRUCALOPRIDE|Prucalopride 2 milligram (mg) tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880051|NCT01147926|P1|Participant Flow|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880052|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880053|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880054|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880055|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880056|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880057|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880058|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880059|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880060|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880061|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880062|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880063|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880064|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880065|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880066|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880067|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880068|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880069|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880070|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880071|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880072|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880073|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880074|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880075|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880076|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880077|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880078|NCT01147926|O2|Outcome|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880079|NCT01147926|O1|Outcome|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880080|NCT01147926|E2|Reported Event|PRUCALOPRIDE|Prucalopride 2 mg tablet orally once daily for subjects ≥18 to less than <65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
880081|NCT01147926|E1|Reported Event|PLACEBO|Placebo matched to Prucalopride tablet orally once daily.
880082|NCT01147900|B4|Baseline|Total|Total of all reporting groups
880083|NCT01147900|B3|Baseline|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880084|NCT01147900|B2|Baseline|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880085|NCT01147900|B1|Baseline|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880086|NCT01147900|P3|Participant Flow|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880087|NCT01147900|P2|Participant Flow|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880169|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880170|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880088|NCT01147900|P1|Participant Flow|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880089|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880090|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880091|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880092|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880093|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880094|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880095|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880096|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880097|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880098|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880099|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880100|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880101|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880102|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880103|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880104|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880105|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880106|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880107|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880108|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880109|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880110|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880111|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880112|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880113|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880114|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880115|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880116|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880117|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880118|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880119|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880120|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880512|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
880121|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880122|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880123|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880124|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880125|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880126|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880127|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880128|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880129|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880130|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880131|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880132|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880133|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880134|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880135|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880136|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880137|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880138|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880139|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880140|NCT01147900|O3|Outcome|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880141|NCT01147900|O2|Outcome|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880142|NCT01147900|O1|Outcome|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880143|NCT01147900|E3|Reported Event|Boostrix-REF Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, reference formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880144|NCT01147900|E2|Reported Event|Boostrix-INV Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, investigational formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, reference formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880145|NCT01147900|E1|Reported Event|Boostrix-US Group|Subjects in this group were healthy adult subjects aged 18 to 28 years at the time of enrolment and with previous completed primary and booster vaccination with a diphtheria-tetanus-whole cell pertussis vaccine completed by one additional booster dose of Boostrix™ vaccine, United States(US)-marketed formulation, at Day 0 in GSK 263855/029 study. These subjects received, as part of this NCT01147900 study, one further booster dose of Boostrix™ vaccine, US-marketed formulation, at Year 10, 10 years after booster vaccination in the GSK 263855/029 study. The Boostrix™ vaccine was administered intramuscularly in the deltoid muscle of the non-dominant arm.
880146|NCT01147874|B1|Baseline|All Participants|Participants with psoriasis were observed for 8 weeks.
880147|NCT01147874|P1|Participant Flow|All Participants|Participants with psoriasis were observed for 8 weeks.
880148|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
880149|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
880150|NCT01147874|O1|Outcome|All Participants|Participants with psoriasis were observed for 8 weeks.
880151|NCT01147874|E1|Reported Event|All Participants|Participants with psoriasis were observed for 8 weeks.
880152|NCT01147848|B3|Baseline|Total|Total of all reporting groups
880153|NCT01147848|B2|Baseline|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880154|NCT01147848|B1|Baseline|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880155|NCT01147848|P3|Participant Flow|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880156|NCT01147848|P2|Participant Flow|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880157|NCT01147848|P1|Participant Flow|Fluticasone Propionate 250 µg BID|Participants received Fluticasone Propionate 250 micrograms (µg) twice a day (BID) and salbutamol/albuterol as required to control symptoms.
880158|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880159|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880160|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880161|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880162|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880163|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880164|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880165|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880166|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880167|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880168|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880171|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880172|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880173|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880174|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880175|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880176|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880177|NCT01147848|O1|Outcome|FFluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880178|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880179|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880180|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880181|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880182|NCT01147848|O2|Outcome|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880183|NCT01147848|O1|Outcome|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880184|NCT01147848|E2|Reported Event|Fluticasone Propionate/Salmeterol 250/50 µg BID|Participants received Fluticasone Propionate (FP)/Salmeterol 250/50 µg inhalation powder BID (in the morning and evening), plus placebo inhalation powder OD in the evening for a period of 24 weeks.
880185|NCT01147848|E1|Reported Event|Fluticasone Furoate/Vilanterol 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 µg once daily (OD) in the evening, plus placebo inhalation powder twice daily (BID; in the morning and evening) for a period of 24 weeks.
880186|NCT01147822|B3|Baseline|Total|Total of all reporting groups
880187|NCT01147822|B2|Baseline|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880188|NCT01147822|B1|Baseline|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880189|NCT01147822|P2|Participant Flow|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880190|NCT01147822|P1|Participant Flow|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880191|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880192|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880193|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880194|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880195|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880196|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880197|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880198|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880199|NCT01147822|O2|Outcome|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880200|NCT01147822|O1|Outcome|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880201|NCT01147822|E2|Reported Event|Sunitinib 50 mg|Participants were administered sunitinib 50 mg capsules orally OD in 6-week cycles (4 weeks of treatment, followed by 2 weeks without treatment). Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880202|NCT01147822|E1|Reported Event|Pazopanib 800 mg|Participants were administered pazopanib 800 milligrams (mg) (2 x 400 mg tablets) orally once daily (OD) continuously. Pazopanib was to be taken at least one hour before or at least two hours after a meal. Study treatment continued until participants experienced disease progression, death, or unacceptable toxicity, or withdrew consent for any other reason.
880203|NCT01147809|B7|Baseline|Total|Total of all reporting groups
880204|NCT01147809|B6|Baseline|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880205|NCT01147809|B5|Baseline|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880206|NCT01147809|B4|Baseline|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880207|NCT01147809|B3|Baseline|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880208|NCT01147809|B2|Baseline|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880209|NCT01147809|B1|Baseline|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880210|NCT01147809|P6|Participant Flow|Phase II: Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880211|NCT01147809|P5|Participant Flow|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880212|NCT01147809|P4|Participant Flow|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880213|NCT01147809|P3|Participant Flow|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of the 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880214|NCT01147809|P2|Participant Flow|Phase I: 21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880215|NCT01147809|P1|Participant Flow|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880513|NCT01147406|O3|Outcome|Cohort 3|N6022 - Active 45 mg
880216|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880217|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880218|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880219|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880220|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880221|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880222|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880223|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880224|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880225|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880226|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880227|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880228|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880229|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880230|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880231|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880232|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880233|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880234|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880235|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880236|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880237|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880238|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880239|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880240|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880241|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880242|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880243|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880244|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880245|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880246|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880247|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880248|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880249|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880250|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880251|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880252|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880253|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880254|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880255|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880256|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880257|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880355|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880258|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880259|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880260|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880261|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880262|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880263|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880264|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880265|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880266|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880267|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880268|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880269|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880270|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880271|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880272|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880273|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880274|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880275|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880276|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880277|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880278|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880356|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880503|NCT01147406|P1|Participant Flow|Cohort 1|5 mg of N6022 was given intravenously daily for 7 days
880279|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880280|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880281|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880282|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg)|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880283|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880284|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880285|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880286|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880287|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880288|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880289|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880290|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880291|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880292|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880293|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880294|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880295|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880296|NCT01147809|O2|Outcome|Eltrombopag 100 mg|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880297|NCT01147809|O1|Outcome|Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880298|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880299|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880300|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880301|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880302|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880303|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880304|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880305|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880306|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880307|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880308|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880309|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880310|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880311|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880312|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880313|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880314|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880315|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880316|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880317|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880318|NCT01147809|O4|Outcome|28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880319|NCT01147809|O3|Outcome|28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880320|NCT01147809|O2|Outcome|21-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880321|NCT01147809|O1|Outcome|21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880322|NCT01147809|E6|Reported Event|Phase II: Eltrombopag|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880323|NCT01147809|E5|Reported Event|Phase II: Placebo|Participants receiving gemcitabine plus carboplatin or cisplatin as a part of 21-day chemotherapy cycle or gemcitabine alone as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of each chemotherapy cycle (up to a maximum of 6 cycles).
880324|NCT01147809|E4|Reported Event|Phase I: 28-Day Cycle Eltrombopag 100 mg|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered eltrombopag 100 mg once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880325|NCT01147809|E3|Reported Event|Phase I: 28-Day Cycle Placebo|Participants receiving gemcitabine on Day 1, Day 8 and Day 15 as a part of 28-day chemotherapy cycle, were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880326|NCT01147809|E2|Reported Event|Phase I: 21-Day Cycle Eltrombopag|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered eltrombopag 100 milligrams (mg) once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880327|NCT01147809|E1|Reported Event|Phase I: 21-Day Cycle Placebo|Participants receiving gemcitabine on Day 1 and Day 8 plus carboplatin (G+Cb) or cisplatin (G+Cis) on Day 1 (Cis may be divided on Day 1 and Day 8) as a part of the 21-day chemotherapy cycle were administered placebo once daily for 5 days before and 5 days after Day 1 of Cycle 2 and subsequent chemotherapy cycles.
880328|NCT01147653|B3|Baseline|Total|Total of all reporting groups
880329|NCT01147653|B2|Baseline|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
880330|NCT01147653|B1|Baseline|Autologous UCB First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
880331|NCT01147653|P2|Participant Flow|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood at Year 1.
880332|NCT01147653|P1|Participant Flow|Autologous UCB Reinfusion First, Then Placebo|Subjects receive autologous umbilical cord blood at Baseline, then Placebo at Year 1.
880333|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
880334|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
880335|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second.
880336|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880337|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880338|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880339|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880340|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880341|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880342|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880343|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880344|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880345|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880346|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880347|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880348|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880349|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880350|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880351|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880352|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880353|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880354|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880504|NCT01147406|O6|Outcome|Placebo|Not Active - Placebo
880357|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880358|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880359|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880360|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880361|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880362|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880363|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880364|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880365|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880366|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880367|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880368|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive Placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880369|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than Placebo at Year 1.
880370|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo first, then autologous umbilical cord blood cell reinfusion at Year 1.
880371|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells first, than placebo at Year 1.
880372|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880373|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880374|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880375|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880376|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo first, then autologous umbilical cord blood cell reinfusion at Year 1.
880377|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First,Then Placebo|Subjects receive their autologous umbilical cord blood cells first, than placebo at Year 1.
880378|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880379|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880380|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880381|NCT01147653|O1|Outcome|Autologous Umbilical Cord Blood Reinfusion|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880382|NCT01147653|O2|Outcome|Placebo First, Then Autologous UCB Reinfusion|Subjects receive placebo at Baseline, then autologous umbilical cord blood cell reinfusion at Year 1.
880383|NCT01147653|O1|Outcome|Autologous UCB Reinfusion First, Then Placebo|Subjects receive their autologous umbilical cord blood cells at Baseline, than placebo at Year 1.
880384|NCT01147653|E2|Reported Event|Placebo|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
880385|NCT01147653|E1|Reported Event|Autologous Umbilical Cord Blood Reinfusion|"All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions.~Autologous Umbilical Cord Blood or Placebo: All participants will be treated with autologous cord blood reinfusion, but the time course will vary between groups and participants will be blinded to the order in which they receive infusions. Patients will be randomized to receive their autologous umbilical cord blood cells first or placebo first. Subjects will receive both infusions but will be randomized and blinded by which they are receiving first and second."
880386|NCT01147640|B3|Baseline|Total|Total of all reporting groups
880387|NCT01147640|B2|Baseline|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
880388|NCT01147640|B1|Baseline|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
880389|NCT01147640|P2|Participant Flow|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
880390|NCT01147640|P1|Participant Flow|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
880505|NCT01147406|O5|Outcome|Cohort 6|N6022 - Active 35 mg
880391|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
880392|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
880393|NCT01147640|O2|Outcome|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
880394|NCT01147640|O1|Outcome|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
880395|NCT01147640|E2|Reported Event|Meropenem With Matching Saline Placebo|meropenem plus saline placebo: meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
880396|NCT01147640|E1|Reported Event|CXA 101/Tazobactam and Metronidazole|CXA-101/ tazobactam and metronidazole: CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
880397|NCT01147627|B4|Baseline|Total|Total of all reporting groups
880398|NCT01147627|B3|Baseline|Thiazolidinedione|
880399|NCT01147627|B2|Baseline|Premixed Insulin Analog|
880400|NCT01147627|B1|Baseline|Exenatide|
880401|NCT01147627|P3|Participant Flow|Pioglitazone|Pioglitazone was commenced at a dose of 30 mg daily, increasing to 45 mg daily after 4 weeks.
880402|NCT01147627|P2|Participant Flow|Premixed Insulin Analog|Premixed insulin was injected twice-daily commencing with 0.4 IU/kg daily, with 50% given 15 minutes before breakfast and dinner respectively
880403|NCT01147627|P1|Participant Flow|Exenatide|5 µg was injected twice-daily subcutaneously increasing to 10 µg twice-daily after 4 weeks. Those who experienced hypoglycaemia frequently or could not tolerate adverse events were instructed to reduce the dose to 5 µg twice-daily.
880404|NCT01147627|O3|Outcome|Thiazolidinedione|
880405|NCT01147627|O2|Outcome|Premixed Insulin Analog|
880406|NCT01147627|O1|Outcome|Exenatide|
880407|NCT01147627|E3|Reported Event|Thiazolidinedione|
880408|NCT01147627|E2|Reported Event|Premixed Insulin Analog|
880409|NCT01147627|E1|Reported Event|Exenatide|
880410|NCT01147497|B3|Baseline|Total|Total of all reporting groups
880411|NCT01147497|B2|Baseline|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
880412|NCT01147497|B1|Baseline|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
880413|NCT01147497|P2|Participant Flow|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
880414|NCT01147497|P1|Participant Flow|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
880415|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
880416|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
880417|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
880418|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
880419|NCT01147497|O2|Outcome|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
880420|NCT01147497|O1|Outcome|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
880421|NCT01147497|E2|Reported Event|Placebo|Pill that is identical to the study drug in appearance, taste, and smell, taken buccally 2 hours prior to IUD insertion visit
880422|NCT01147497|E1|Reported Event|Misoprostol|Misoprostol 400mcg taken buccally 2 hours prior to IUD insertion visit
880423|NCT01147471|B3|Baseline|Total|Total of all reporting groups
880424|NCT01147471|B2|Baseline|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880425|NCT01147471|B1|Baseline|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
880426|NCT01147471|P2|Participant Flow|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880460|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880461|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880462|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880427|NCT01147471|P1|Participant Flow|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
880428|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880429|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
880430|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880431|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
880432|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880433|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
880434|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880435|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
880436|NCT01147471|O2|Outcome|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880500|NCT01147406|P4|Participant Flow|Cohort 5|25 mg of N6022 was given intravenously daily for 7 days
880437|NCT01147471|O1|Outcome|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize the stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize the stove-in segment. Post-operatively, the patients would receive the standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system."
880438|NCT01147471|E2|Reported Event|Non-operative Arm|"Randomized subjects to receive standard of care therapy for blunt thoracic trauma (as per each participating institution's own protocols):~a. Ventilatory support b.Timing of extubation (removal from ventilator): c.Analgesia: institution should provide adequate analgesia utilizing available resources including oral, parenteral, epidural, local nerve blocks etc., d.Chest physical therapy, e.Postural drainage, f.Incentive spirometry – after extubation."
880439|NCT01147471|E1|Reported Event|Operative Rib Fixation|"Randomized subjects will be operated upon within 72 hours of ventilation (early fixation) to stabilize stove-in segment. Where all fractured ribs are accessible and the number of fractured ribs is few, stabilization of all fractured ribs would be the goal. However, where fractured ribs are in areas difficult to access, enough ribs, based on surgeon judgment, would be fixed to stabilize stove-in segment. Post-operatively, the patients would receive standard of care, similar to what is outlined for the non-operative arm.~Operative fixation will be accomplished utilizing the MatrixRIB Fixation System (Synthes CMF, West Chester, PA, USA) according to the device's instructions for use. Sites will obtain the product based on their medical center's normal purchasing practices.~operative rib fixation: Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.~operative rib fix"
880440|NCT01147458|B1|Baseline|Entire Study Population|Includes groups randomized to receive PF-04191834 first, placebo first, PF-04191834 plus naproxen first, and naproxen first.
880441|NCT01147458|P4|Participant Flow|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880442|NCT01147458|P3|Participant Flow|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880443|NCT01147458|P2|Participant Flow|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880444|NCT01147458|P1|Participant Flow|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880445|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880446|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880447|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880448|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880449|NCT01147458|O2|Outcome|PF-04191834 600 mg BID + Naproxen 500 mg BID|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
880450|NCT01147458|O1|Outcome|PF-04191834 600 mg BID|PF-04191834 600 mg BID administered either in Period 1 or Period 2
880451|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880452|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880453|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880454|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880455|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880456|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880457|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880458|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880459|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880501|NCT01147406|P3|Participant Flow|Cohort 3|45 mg of N6022 was to be given intravenously daily for 7 days however, the actual amount was 27.5 mg.
880463|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880464|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880465|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880466|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880467|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880468|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880469|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880470|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880471|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880472|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880473|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880474|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880475|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880476|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880477|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880478|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880479|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880480|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880481|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880482|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880483|NCT01147458|O4|Outcome|Naproxen Followed by PF-04191834 + Naproxen|Naproxen 500 mg BID plus PF-04191834 placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen 500 mg BID for another 2 weeks.
880484|NCT01147458|O3|Outcome|PF-04191834 + Naproxen Followed by Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID for 2 weeks with a 2-week washout period, followed by naproxen 500 mg BID plus PF-04191834 placebo for another 2 weeks.
880485|NCT01147458|O2|Outcome|Placebo Followed by PF-04191834|PF-04191834 placebo plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 600 mg BID plus naproxen placebo for another 2 weeks.
880486|NCT01147458|O1|Outcome|PF-04191834 Followed by Placebo|PF-04191834 600 milligrams (mg) twice daily (BID) plus naproxen placebo for 2 weeks with a 2-week washout period, followed by PF-04191834 placebo plus naproxen placebo for another 2 weeks.
880487|NCT01147458|E4|Reported Event|Naproxen|Naproxen 500 mg BID administered either in Period 1 or Period 2
880488|NCT01147458|E3|Reported Event|PF-04191834 + Naproxen|PF-04191834 600 mg BID plus naproxen 500 mg BID administered either in Period 1 or Period 2
880489|NCT01147458|E2|Reported Event|Placebo|Placebo administered either in Period 1 or Period 2
880490|NCT01147458|E1|Reported Event|PF-04191834|PF-04191834 600 mg BID administered either in Period 1 or Period 2
880491|NCT01147406|B7|Baseline|Total|Total of all reporting groups
880492|NCT01147406|B6|Baseline|Placebo|Not Active - Placebo
880493|NCT01147406|B5|Baseline|Cohort 6|N6022 - Active 35 mg
880494|NCT01147406|B4|Baseline|Cohort 5|N6022 - Active 25 mg
880495|NCT01147406|B3|Baseline|Cohort 3|N6022 - Active 45 mg (actual *27.5 mg)
880496|NCT01147406|B2|Baseline|Cohort 2 & 4|N6022 - Active 15 mg
880497|NCT01147406|B1|Baseline|Cohort 1|N6022 - Active 5 mg
880498|NCT01147406|P6|Participant Flow|Placebo|Not Active - Placebo
880499|NCT01147406|P5|Participant Flow|Cohort 6|35 mg of N6022 was given intravenously daily for 7 days
880506|NCT01147406|O4|Outcome|Cohort 5|N6022 - Active 25 mg
880522|NCT01147393|B1|Baseline|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
880523|NCT01147393|P1|Participant Flow|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
880524|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
880525|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
880526|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
880527|NCT01147393|O1|Outcome|All Subjects|"two weekly infusions of 90Y-epratuzumab tetraxetan in combination with four weekly infusions of 200 mg/m2 veltuzumab.~90Y-epratuzumab tetraxetan: The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.~veltuzumab: Veltuzumab is given in 4 weekly doses, each 200 mg/m2."
880528|NCT01147393|E2|Reported Event|Dose Level -1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 10 mCi/m2
880529|NCT01147393|E1|Reported Event|Dose Level 1|veltzumab: 200 mg/m2 Unconjugated epratuzumab: 1.5 mg/kg 111-In-epratuzumab: 5 mCi 90-Y-epratuzumab: 15 mCi/m2
880530|NCT01147380|B3|Baseline|Total|Total of all reporting groups
880531|NCT01147380|B2|Baseline|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880532|NCT01147380|B1|Baseline|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880533|NCT01147380|P2|Participant Flow|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
880534|NCT01147380|P1|Participant Flow|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive liver NK cell inoculation several days after liver transplantation."
880535|NCT01147380|O2|Outcome|Large Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells(mainly NK cells) is between 100 and 1000 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate.Patient of this arm receive large dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880536|NCT01147380|O1|Outcome|Small Dose|"From the donor liver perfusate, mononuclear cell will be extracted and cultured. Then, the cells will be stimulated with IL-2. The number of inoculation cells( mainly NK cells) is between 10 and 100 million cells. The cells will be given to the liver transplant recipient who had the same donor for liver and liver perfusate. Patient of this arm receive small dose of liver NK cell inoculation as described.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880537|NCT01147380|O2|Outcome|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880538|NCT01147380|O1|Outcome|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880539|NCT01147380|E2|Reported Event|Large Dose|"The number of inoculation cells is between 100 and 1000 million cells~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880540|NCT01147380|E1|Reported Event|Small Dose|"The number of inoculation cells is between 10 and 100 million cells.~Liver NK cell inoculation: Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation."
880541|NCT01147341|B3|Baseline|Total|Total of all reporting groups
880542|NCT01147341|B2|Baseline|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880543|NCT01147341|B1|Baseline|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880544|NCT01147341|P2|Participant Flow|Placebo|"Reporting group: Placebo : prefilled saline syringe during the Double Blind Period~10 patients entered"
880545|NCT01147341|P1|Participant Flow|Active Treatment With Cimzia|"Reporting group: Cimzia : prefilled 200mg Cimzia syringes. Cimzia 400mg SC at baseline, weeks 2 and 4 and Cimzia 200mg SC at weeks 6, 8, and 10 during the Double Blind Portion.~Cimzia 400mg SC at weeks 12, 14, and 16 and Cimzia 200mg SC at weeks 18, 20, and 22.~27 patients entered the Double Blind Portion."
880546|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880547|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880548|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880549|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880550|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880551|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880552|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880553|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880554|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880555|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880556|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880557|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880558|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880559|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880560|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880561|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880562|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880563|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880564|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880565|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880566|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880567|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880568|NCT01147341|O2|Outcome|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880569|NCT01147341|O1|Outcome|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880570|NCT01147341|E2|Reported Event|Placebo|"Placebo : prefilled saline syringe~10 patients entered"
880571|NCT01147341|E1|Reported Event|Active Treatment With Cimzia|"Cimzia : prefilled 200mg Cimzia syringe SC q 2 weeks~27 patients entered"
880572|NCT01147302|B3|Baseline|Total|Total of all reporting groups
880573|NCT01147302|B2|Baseline|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880574|NCT01147302|B1|Baseline|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880575|NCT01147302|P2|Participant Flow|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880576|NCT01147302|P1|Participant Flow|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880577|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880578|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880579|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880580|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
892158|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
880581|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880582|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880583|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880584|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880585|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880586|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880587|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880588|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880589|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880590|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880591|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880592|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880593|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880594|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880595|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880596|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880597|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880598|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880599|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880600|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880601|NCT01147302|O2|Outcome|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880602|NCT01147302|O1|Outcome|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880603|NCT01147302|E2|Reported Event|CINRYZE|Participants received an intravenous (IV) infusion of human C1 esterase inhibitor (CINRYZE) at a rate of approximately 1 mL per minute as tolerated. Participants received a total of 7 doses over a 2-week period: an initial IV infusion of 5000 U (not to exceed 100 U/kg) on Day 1, followed by 2500 U (not to exceed 50 U/kg) IV on Days 3, 5, 7, 9, 11, and 13.
880604|NCT01147302|E1|Reported Event|Placebo|Participants received an intravenous (IV) infusion of normal saline, at a rate of approximately 1 mL per minute as tolerated, 7 times over a 2-week period: an initial infusion on Day 1, followed by infusions on Days 3, 5, 7, 9, 11, and 13.
880605|NCT01147250|B3|Baseline|Total|Total of all reporting groups
880606|NCT01147250|B2|Baseline|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
880607|NCT01147250|B1|Baseline|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
880608|NCT01147250|P2|Participant Flow|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
880609|NCT01147250|P1|Participant Flow|Placebo|Placebo matched to lixisenatide once daily (QD) subcutaneously (SC) up to end of treatment (median exposure: 23 months).
880610|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
880611|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
880612|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
880613|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
880614|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
880615|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
880616|NCT01147250|O2|Outcome|Lixisenatide|Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to end of treatment (median exposure: 22 months).
880617|NCT01147250|O1|Outcome|Placebo|Placebo matched to lixisenatide QD SC up to end of treatment (median exposure: 23 months).
880618|NCT01147250|E2|Reported Event|Lixisenatide|Participants exposed to Lixisenatide 10 mcg QD SC for 2 weeks post-randomization, then at a maintenance dose of 20 mcg QD up to 225 weeks. (Median exposure: 22 months)
880619|NCT01147250|E1|Reported Event|Placebo|Participants exposed to Placebo matched to lixisenatide QD. (Median exposure: 23 months)
880620|NCT01147172|B1|Baseline|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
880621|NCT01147172|P1|Participant Flow|Elevess|"Gel implant (dermal filler) composed of hyaluronan produced by Streptococcus equi (bacterial fermentation) that is cross-linked and suspended in phosphate buffered saline with 0.3% lidocaine HCl and 0.1% sodium metabisulfite~Elevess : Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles"
880622|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
880623|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
880624|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
880625|NCT01147172|O1|Outcome|Elevess|Subjects received injection(s) and exhibited pigmentation changes at End of Study.
880626|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation at End of Study.
880627|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
880628|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
880629|NCT01147172|O1|Outcome|Elevess|Subjects that received injection(s) of Elevess and exhibited keloid formation.
880630|NCT01147172|E1|Reported Event|Safety Population|All Subjects receiving treatment of nasolabial folds (NLF) with injection of Elevess.
880631|NCT01147068|B8|Baseline|Total|Total of all reporting groups
880632|NCT01147068|B7|Baseline|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880633|NCT01147068|B6|Baseline|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880634|NCT01147068|B5|Baseline|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880635|NCT01147068|B4|Baseline|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880636|NCT01147068|B3|Baseline|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880637|NCT01147068|B2|Baseline|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880638|NCT01147068|B1|Baseline|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880639|NCT01147068|P7|Participant Flow|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880640|NCT01147068|P6|Participant Flow|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880641|NCT01147068|P5|Participant Flow|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880642|NCT01147068|P4|Participant Flow|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880643|NCT01147068|P3|Participant Flow|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880644|NCT01147068|P2|Participant Flow|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880645|NCT01147068|P1|Participant Flow|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880646|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880647|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880648|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880649|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880650|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880651|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880652|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880653|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880654|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880655|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880656|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880657|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880658|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880659|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880660|NCT01147068|O7|Outcome|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880661|NCT01147068|O6|Outcome|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880662|NCT01147068|O5|Outcome|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880663|NCT01147068|O4|Outcome|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880933|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880664|NCT01147068|O3|Outcome|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880665|NCT01147068|O2|Outcome|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880666|NCT01147068|O1|Outcome|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880667|NCT01147068|E7|Reported Event|PanBlok 3.8µg and GLA 1.0µg, SE 2%|"3.8µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880668|NCT01147068|E6|Reported Event|PanBlok 7.5µg and GLA 1.0µg, SE 2%|"7.5µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880669|NCT01147068|E5|Reported Event|PanBlok 15µg and GLA 1.0µg, SE 2%|"15µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880670|NCT01147068|E4|Reported Event|PanBlok 45µg and GLA 1.0µg, SE 2%|"45µg recombinant hemagglutinin and Glucopyranosyl Lipid A 1.0µg in a 2% oil-in-water stable emulsion; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880671|NCT01147068|E3|Reported Event|PanBlok 45µg No Adjuvant|"45µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880672|NCT01147068|E2|Reported Event|PanBlok 135µg No Adjuvant|"135µg recombinant hemagglutinin, no adjuvant; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880673|NCT01147068|E1|Reported Event|Placebo|"0.9% Sodium Chloride; Two 0.5 mL IM injections 21 days apart~0.5mL Intramuscular Injection : 0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle"
880674|NCT01147055|B1|Baseline|Entire Study Population|Includes participants randomized to receive crizotinib 250 mg IRT first and then crizotinib 250 mg + rifampin 600 mg.
880675|NCT01147055|P2|Participant Flow|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in fasted state from Day 1 to Day 14. A single oral dose of crizotinib 250 mg IRTs was administered on Day 9 in second intervention period. A washout period of at least 14 days was maintained between each period.
880676|NCT01147055|P1|Participant Flow|Crizotinib 250 mg|Single oral dose of crizotinib 250 milligram (mg) immediate-release tablet (IRT) on Day 1 in first intervention period. A washout period of at least 14 days was maintained between each period.
880677|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880678|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880679|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880680|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880681|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880682|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880683|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880684|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880685|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880686|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880687|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880688|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880689|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880690|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880691|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880692|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880693|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880694|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
892159|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
880695|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880696|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880697|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880698|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880699|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880700|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880701|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880702|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880703|NCT01147055|O2|Outcome|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880704|NCT01147055|O1|Outcome|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880705|NCT01147055|E2|Reported Event|Crizotinib 250 mg + Rifampin 600 mg|Single oral dose of rifampin 600 mg tablet in the fasted state from Day 1 to Day 14 and single oral dose of crizotinib 250 mg IRTs on Day 9 in second intervention period [Treatment B (Test)].
880706|NCT01147055|E1|Reported Event|Crizotinib 250 mg|Single oral dose of crizotinib 250 mg IRT in first intervention period [Treatment A (Reference)].
880707|NCT01146951|B3|Baseline|Total|Total of all reporting groups
880708|NCT01146951|B2|Baseline|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880709|NCT01146951|B1|Baseline|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
880710|NCT01146951|P2|Participant Flow|Placebo|Placebo : Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880711|NCT01146951|P1|Participant Flow|Rufinamide (E2080)|"Rufinamide : Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.~Target maintenance dose:~15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)"
880712|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880713|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
880714|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880715|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
880716|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880717|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
880718|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880800|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
880719|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
880720|NCT01146951|O2|Outcome|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880721|NCT01146951|O1|Outcome|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
880722|NCT01146951|E2|Reported Event|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
880723|NCT01146951|E1|Reported Event|Rufinamide (E2080)|Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period. Target maintenance dose: 15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)
880724|NCT01146912|B8|Baseline|Total|Total of all reporting groups
880725|NCT01146912|B7|Baseline|Delayed Pediatrics: Usual Care|
880726|NCT01146912|B6|Baseline|Delayed Pediatrics: Conventional Text Message|
880727|NCT01146912|B5|Baseline|Delayed Pediatrics: Interactive Text Message|
880728|NCT01146912|B4|Baseline|Pregnant Women: Usual Care|
880729|NCT01146912|B3|Baseline|Pregnant Women: Text Message|
880730|NCT01146912|B2|Baseline|Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
880731|NCT01146912|B1|Baseline|Text Message Vaccine Reminders/Automated Telephone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
880732|NCT01146912|P8|Participant Flow|Parents|Included in enrollment but not in outcomes which are on child level
880733|NCT01146912|P7|Participant Flow|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
880734|NCT01146912|P6|Participant Flow|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
880735|NCT01146912|P5|Participant Flow|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
880736|NCT01146912|P4|Participant Flow|Pregnant Women: Usual Care|Received usual care
880737|NCT01146912|P3|Participant Flow|Pregnant Women: Text Message|Received text message reminders
880738|NCT01146912|P2|Participant Flow|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
880739|NCT01146912|P1|Participant Flow|Pediatric Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
880740|NCT01146912|O3|Outcome|Delayed Pediatric: Usual Care|Vaccination of children not yet vaccinated by mid-November: usual care
880741|NCT01146912|O2|Outcome|Delayed Pediatric: Conventional Text Message|Vaccination of children not yet vaccinated by mid-November: conventional text message
880742|NCT01146912|O1|Outcome|Delayed Pediatrics: Interactive Text Message Vaccine Reminders|Vaccination of children not yet vaccinated by mid-November: interactive message
880743|NCT01146912|O2|Outcome|Pregnant Women: Usual Care|
880744|NCT01146912|O1|Outcome|Pregnant Women: Text Message|
880745|NCT01146912|O2|Outcome|Automated Phone Call From Clinic|"Receipt of automated phone call from clinic~automated call: Automated call"
880746|NCT01146912|O1|Outcome|Text Message Vaccine Reminders|"Receipt of text message vaccine reminders~Text Message: Text message vaccine reminders~automated call: Automated call"
880747|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
880748|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine Reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
880749|NCT01146912|O2|Outcome|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
880750|NCT01146912|O1|Outcome|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
880751|NCT01146912|E7|Reported Event|Delayed Pediatric: Usual Care|
880752|NCT01146912|E6|Reported Event|Delayed Pediatric: Conventional Text Message|
880753|NCT01146912|E5|Reported Event|Delayed Pediatric: Interactive Text Message|
880754|NCT01146912|E4|Reported Event|Pregnant Women: Usual Care|
880755|NCT01146912|E3|Reported Event|Pregnant Women: Text Message|
880756|NCT01146912|E2|Reported Event|Pediatric: Automated Phone Call From Clinic Only|Receipt of automated phone call from clinic
880757|NCT01146912|E1|Reported Event|Pediatric: Text Message Vaccine-reminders/Automated Phone Call|Receipt of text message vaccine reminders, in addition to standard of care of automated phone call from clinic
880758|NCT01146873|B3|Baseline|Total|Total of all reporting groups
880801|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
892160|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
880759|NCT01146873|B2|Baseline|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
880760|NCT01146873|B1|Baseline|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
880761|NCT01146873|P2|Participant Flow|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
880762|NCT01146873|P1|Participant Flow|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher.
880763|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
880764|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
880765|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
880766|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
880767|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
880768|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
880769|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
880770|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
880771|NCT01146873|O2|Outcome|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen
880772|NCT01146873|O1|Outcome|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen
880773|NCT01146873|E2|Reported Event|Group 2: Efavirenz (EFV)|Participants are assigned to switch to an EFV-based antiretroviral regimen. Efavirenz was prescribed once daily in the evening at 200 mg for weights of 10 kg to 13.9 kg (22-30 lb) and 300mg for weights of 14 kg to 24.9 kg (31-55 lb). Efavirenz was available in 50-mg and 200-mg capsules. If children were unable to swallow capsules, caregivers were shown how to open the capsules and dissolve the contents in water.
880774|NCT01146873|E1|Reported Event|Group 1: Lopinavir/Ritonavir (LPV/r)|Participants are assigned to remain on their current LPV/r-based antiretroviral regimen. Ritonavir-boosted lopinavir syrup was given twice per day at 230 mg/m^2 per dose. Children able to swallow tablets were given 1 tablet twice per day (200 mg lopinavir/50 mg ritonavir) if body surface area was less than 0.9m^2 or 2 tablets twice per day if body surface area was 0.9m^2 or higher
880775|NCT01146860|B3|Baseline|Total|Total of all reporting groups
880776|NCT01146860|B2|Baseline|Placebo|sugar coated tablets
880777|NCT01146860|B1|Baseline|BNO 1016|sugar coated tablets
880778|NCT01146860|P2|Participant Flow|Placebo|sugar coated tablets of identical appearance to active treatment
880779|NCT01146860|P1|Participant Flow|BNO 1016|sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; daily dose: 480 mg (2 tablets tid)
880780|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
880781|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
880782|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
880783|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
880784|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
880785|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
880786|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
880787|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
880788|NCT01146860|O2|Outcome|Placebo|sugar coated tablets
880789|NCT01146860|O1|Outcome|BNO 1016|sugar coated tablets
880790|NCT01146860|E2|Reported Event|Placebo|sugar coated tablets
880791|NCT01146860|E1|Reported Event|BNO 1016|sugar coated tablets
880792|NCT01146808|B1|Baseline|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
880793|NCT01146808|P1|Participant Flow|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
880794|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
880795|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
880796|NCT01146808|O1|Outcome|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
880797|NCT01146808|E1|Reported Event|ADV Plus Hepatitis B Vaccination Group|This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection.
880798|NCT01146782|B1|Baseline|Safety Cohort|Demographics and Baseline Characteristics are presented for the Safety Cohort (N=146)
880799|NCT01146782|P1|Participant Flow|Sleep Apnea Treatment (Primary Endpoint Cohort)|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) polysomnogram (PSG).
880802|NCT01146782|O1|Outcome|Safety Cohort|The Safety Cohort is comprised of all subjects with at least one night of Winx therapy usage.
880803|NCT01146782|O1|Outcome|Primary Endpoint Cohort|The Treatment group (Primary Endpoint Cohort) includes subjects with an evaluable control (without Attune system) and treatment (with Attune system) PSG.
880804|NCT01146782|E1|Reported Event|Safety Cohort|Device related adverse events are presented for the Safety Cohort.
880805|NCT01146613|B3|Baseline|Total|Total of all reporting groups
880806|NCT01146613|B2|Baseline|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
880807|NCT01146613|B1|Baseline|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
880808|NCT01146613|P2|Participant Flow|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
880809|NCT01146613|P1|Participant Flow|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
880810|NCT01146613|O2|Outcome|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
880811|NCT01146613|O1|Outcome|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
880812|NCT01146613|E2|Reported Event|Sugar Pill|Placebo: identical matched placebo x 2, 2xday, 13 weeks
880813|NCT01146613|E1|Reported Event|Varenicline|"Varenicline Tartrate~Varenicline: 0.5mg capsules x 2, 2x a day for 12 weeks"
880814|NCT01146600|B3|Baseline|Total|Total of all reporting groups
880815|NCT01146600|B2|Baseline|Placebo, Then Clarithromycin|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Placebo then Clarithromycin : Matched placebo po bid (with breakfast and lunch) for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks"
880816|NCT01146600|B1|Baseline|Clarithromycin, Then Placebo|"Subjects will be randomized to group A or group B. The order of presentation of placebo and clarithromycin will be opposite in these two groups, but investigators and subjects will remain blinded to group allocation and order of treatment presentation within the groups.~Clarithromycin followed by placebo : Clarithromycin 500 mg po bid (with breakfast and lunch) for two weeks, then one week with no medication, then matched placebo po bid (with breakfast and lunch) for two weeks."
880817|NCT01146600|P2|Participant Flow|Placebo, Then Clarithromycin|Subjects randomized to receive placebo first (for two weeks), then clarithromycin (for an additional two weeks, following the washout)
880818|NCT01146600|P1|Participant Flow|Clarithromycin, Then Placebo|Subjects randomized to receive clarithromycin first (for two weeks), then matched placebo (for an additional two weeks, following the washout)
880819|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
880820|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
880821|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880822|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
880823|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
880824|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880825|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
880826|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
880827|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880828|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
880829|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
880830|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880831|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
880832|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
880833|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880834|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
880835|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
880836|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880837|NCT01146600|O3|Outcome|Baseline|Baseline values (prior to first study drug) for the 20 subjects who completed both treatment arms.
880838|NCT01146600|O2|Outcome|Placebo|Matched placebo with breakfast and with lunch for two weeks
880839|NCT01146600|O1|Outcome|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880840|NCT01146600|E2|Reported Event|Placebo|Matched placebo with breakfast and with lunch for two weeks
880841|NCT01146600|E1|Reported Event|Clarithromycin|Clarithromycin 500 mg with breakfast and 500 mg with lunch for two weeks
880842|NCT01146457|B6|Baseline|Total|Total of all reporting groups
880843|NCT01146457|B5|Baseline|Morphine 100|Morphine 100 micrograms
880844|NCT01146457|B4|Baseline|Hine 75|Morphine 75 micrograms
880845|NCT01146457|B3|Baseline|Morphine 50|Morphine 50 micrograms
880846|NCT01146457|B2|Baseline|Morphine 25|Morphine 25 micrograms
880847|NCT01146457|B1|Baseline|Placebo|Saline control
880848|NCT01146457|P5|Participant Flow|Morphine 100|Morphine 100 micrograms: Active dosage
880849|NCT01146457|P4|Participant Flow|Morphine 75|Morphine 75 micrograms: Active dosage
880850|NCT01146457|P3|Participant Flow|Morphine 50|Morphine 50 micrograms: Active dosage
880851|NCT01146457|P2|Participant Flow|Morphine 25|Morphine 25 micrograms: Active dosage
880852|NCT01146457|P1|Participant Flow|Placebo|Saline: Saline Control
880853|NCT01146457|O5|Outcome|Morphine 100|Morphine 100 micrograms
880854|NCT01146457|O4|Outcome|Morphine 75|Morphine 75 micrograms
880864|NCT01146418|B2|Baseline|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880865|NCT01146418|B1|Baseline|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880866|NCT01146418|P4|Participant Flow|recFSH 300 IU Live-Born Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
880867|NCT01146418|P3|Participant Flow|Corifollitropin Alfa 150 μg Live-Born Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
880868|NCT01146418|P2|Participant Flow|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880869|NCT01146418|P1|Participant Flow|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880870|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880871|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880872|NCT01146418|O2|Outcome|recFSH 300 IU Women/Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880873|NCT01146418|O1|Outcome|Corifollitropin Alfa 150 μg Women/Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880874|NCT01146418|E6|Reported Event|recFSH 300 IU Follow-up Fetuses/Infants|Infants born to eligible participants who received daily 300 IU recFSH in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice
880875|NCT01146418|E5|Reported Event|Corifollitropin Alfa 150 μg Follow-up Fetuses/Infants|Infants born to eligible participants who received a single injection of 150 μg corifollitropin alfa in Base Study P06029 (NCT01144416) were followed for safety and efficacy in Follow-Up Study P06031 according to standard practice.
880876|NCT01146418|E4|Reported Event|recFSH 300 IU Expectant Mothers|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880877|NCT01146418|E3|Reported Event|Corifollitropin Alfa 150 μg Expectant Mothers|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880878|NCT01146418|E2|Reported Event|recFSH 300 IU Participants With ET|Participants in the reference group in Base Study P06029 (NCT01144416) received a single injection of placebo for corifollitropin alfa on Stimulation Day 1 and daily injections of 300 IU recFSH on Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880879|NCT01146418|E1|Reported Event|Corifollitropin Alfa 150 μg Participants With ET|Participants in Base Study P06029 (NCT01144416) received a single injection of 150 ug corifollitropin alfa on Stimulation Day 1 and daily injections of placebo-recFSH from Stimulation Days 1 through 7. Eligible participants from the base study could enroll in Follow-Up Study P06031. No medication or investigational product was administered in this follow-up study.
880880|NCT01146379|B5|Baseline|Total|Total of all reporting groups
880881|NCT01146379|B4|Baseline|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880882|NCT01146379|B3|Baseline|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880883|NCT01146379|B2|Baseline|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880884|NCT01146379|B1|Baseline|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880885|NCT01146379|P4|Participant Flow|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880886|NCT01146379|P3|Participant Flow|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880887|NCT01146379|P2|Participant Flow|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880888|NCT01146379|P1|Participant Flow|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880889|NCT01146379|O4|Outcome|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880890|NCT01146379|O3|Outcome|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880891|NCT01146379|O2|Outcome|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880926|NCT01145898|P1|Participant Flow|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
880927|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880928|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880929|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
892161|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
880892|NCT01146379|O1|Outcome|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880893|NCT01146379|E4|Reported Event|Individual Maximum High Movement Dose|Intensive task-specific upper extremity rehabilitation: Individualized Maximum repetitions. The participants will continue to receive the training until performance plateaus. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880894|NCT01146379|E3|Reported Event|High Movement Dose, 9600 Total Reps|Intensive task-specific upper extremity rehabilitation: 9600 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880895|NCT01146379|E2|Reported Event|Medium Movement Dose, 6400 Total Reps|Intensive task-specific upper extremity rehabilitation: 6400 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880896|NCT01146379|E1|Reported Event|Low Movement Dose, 3200 Total Reps|Intensive task-specific upper extremity rehabilitation: 3200 total repetitions. The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
880897|NCT01146288|B3|Baseline|Total|Total of all reporting groups
880898|NCT01146288|B2|Baseline|Furosemide First, Then Acetazolamide|intravenous furosemide 2 mg/5min. in first intervention period, intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
880899|NCT01146288|B1|Baseline|Acetazolamide First, Then Furosemide|intravenous acetazolamide 5 mg/kg/5 min. in first intervention period, intravenous furosemide 2 mg/5min in second intervention period (after washout period).
880900|NCT01146288|P2|Participant Flow|Furosemide First , Than Acetazolamide|Intravenous furosemide 2 mg/5min in first intervention period and intravenous acetazolamide 5 mg/kg/5 min. in second intervention period (after washout period).
880901|NCT01146288|P1|Participant Flow|Acetazolamide First, Then Furosemide|Intravenous acetazolamide 5 mg/kg/5 min. in first intervention period and intravenous furosemide 2 mg/5min in second intervention period (after washout period).
880902|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
880903|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
880904|NCT01146288|O2|Outcome|Furosemide|intravenous furosemide 2 mg/5min.
880905|NCT01146288|O1|Outcome|Acetazolamide|intravenous acetazolamide 5 mg/kg/5 min.
880906|NCT01146288|E3|Reported Event|P-aminohippuric Acid|Intravenous priming dose of p-aminohippuric acid (8 mg/kg) before diuretics administration
880907|NCT01146288|E2|Reported Event|Furosemide|Intravenous furosemide 2 mg/5min
880908|NCT01146288|E1|Reported Event|Acetazolamide|Intravenous acetazolamide 5 mg/kg/5 min.
880909|NCT01146275|B1|Baseline|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
880910|NCT01146275|P1|Participant Flow|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enroled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
880911|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Participants with AE/SAE since participation in study 31GB0106 or any findings at the breast examination, mammography, ultrasound or comprehensive MRI investigation"
880912|NCT01146275|O1|Outcome|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane (Hyaluronic acid) for breast augmentation.~Radiologial breast examination : MRI of breast, mammography and ultrasound of breast The MRI investigation was performed to evaluate if the subjects has study product (Macrolane-a Hyaluronic acid) in their breast 7 years after the treatment."
880913|NCT01146275|E1|Reported Event|Participants in the Pilot Study 31GB0601|"This is an additional safety follow up 7-years post treatment, for subjects enrolled in a pilot study using a previous formulation of Macrolane for breast augmentation.~Radiologial breast examination : MRI of breast, mammograophy and ultrasound of breast"
880930|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880931|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880914|NCT01146054|B1|Baseline|SBRT and Gemzar|"Before stereotactic Body Radiotherapy (SBRT) 3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles should resume/start up to 4 weeks following SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Device: CyberKnife based stereotactic radiotherapy"
880915|NCT01146054|P1|Participant Flow|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose 18F-positron emission tomography/computerized tomography) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D (4 dimensional) pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
880916|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
880917|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
880918|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
880919|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
880920|NCT01146054|O1|Outcome|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
880921|NCT01146054|E1|Reported Event|SBRT and Gemzar|"3-5 gold fiducials are placed by endoscopic ultrasound or CT guidance. A simulation FDG-PET/CT (Fludeoxyglucose (18F)) scan will be used for treatment planning purposes (standard free-breathing CT and respiratory-correlated 4-D pancreatic protocol CT). Patients are treated by either respiratory gated (Trilogy, Elekta, Novalis) or by respiratory tracking (CyberKnife). SBRT is delivered in 5 fractions of 6.6 Gy by LINAC-based or CyberKnife based radiotherapy over a five-day period. Gemcitabine, cycles starts within 4 weeks of SBRT on a 3-week on, 1-week off schedule. Initial follow up is at 4, 6, 9 and 12 months and then for years 2-5 is every 3-6 months.~Fludeoxyglucose (18F): FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv"
880922|NCT01145898|B3|Baseline|Total|Total of all reporting groups
880923|NCT01145898|B2|Baseline|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
880924|NCT01145898|B1|Baseline|Trusopt|Patients with glaucoma taking Trusopt or Cosopt alone or with prostaglandin for at least 6 months
880925|NCT01145898|P2|Participant Flow|Prostaglandin Alone|Patients with glaucoma taking prostaglandin alone for at least 6 months
880932|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880934|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880935|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880936|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880937|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880938|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880939|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880940|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880941|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880942|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880943|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880944|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880945|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880946|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880947|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880948|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880949|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880950|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880951|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880952|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880953|NCT01145898|O2|Outcome|Prostaglandin Alone|Patients taking prostaglandin alone
880954|NCT01145898|O1|Outcome|Trusopt|Patients taking trusopt or cosopt alone or with prostaglandin
880955|NCT01145898|E1|Reported Event|Glaucoma Patients|Patients with Glaucoma
880956|NCT01145755|B4|Baseline|Total|Total of all reporting groups
880957|NCT01145755|B3|Baseline|Placebo|Placebo
880958|NCT01145755|B2|Baseline|Duloxetine|Duloxetine 30 mg, 60 mg
880959|NCT01145755|B1|Baseline|AZD2066|AZD2066 12 mg, 18 mg
880960|NCT01145755|P3|Participant Flow|Placebo|Placebo
880961|NCT01145755|P2|Participant Flow|Duloxetine|Duloxetine 30 mg, 60 mg
880962|NCT01145755|P1|Participant Flow|AZD2066|AZD2066 12 mg, 18 mg
880963|NCT01145755|O3|Outcome|Placebo|Placebo
880964|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
880965|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
880966|NCT01145755|O3|Outcome|Placebo|Placebo
880967|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
880968|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
880969|NCT01145755|O3|Outcome|Placebo|Placebo
880970|NCT01145755|O2|Outcome|Duloxetine|Duloxetine 30 mg, 60 mg
880971|NCT01145755|O1|Outcome|AZD2066|AZD2066 12 mg, 18 mg
880972|NCT01145755|E3|Reported Event|Placebo|Placebo
880973|NCT01145755|E2|Reported Event|Duloxetine|Duloxetine 30 mg, 60 mg
880974|NCT01145755|E1|Reported Event|AZD2066|AZD2066 12 mg, 18 mg
880975|NCT01145638|B3|Baseline|Total|Total of all reporting groups
880976|NCT01145638|B2|Baseline|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
880977|NCT01145638|B1|Baseline|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
880978|NCT01145638|P2|Participant Flow|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
880979|NCT01145638|P1|Participant Flow|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
880980|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
880981|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
880982|NCT01145638|O2|Outcome|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
880983|NCT01145638|O1|Outcome|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
880984|NCT01145638|E2|Reported Event|Iron Sulphate|"oral iron sulphate twice a day~iron sulphate: oral, 200 mg per day (100 mg bid),12 weeks"
880985|NCT01145638|E1|Reported Event|Iron Isomaltoside 1000|"Iron isomaltoside intravenously as bolus or infusion~iron isomaltoside 1000: intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose"
880986|NCT01145625|B3|Baseline|Total|Total of all reporting groups
880987|NCT01145625|B2|Baseline|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
880988|NCT01145625|B1|Baseline|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
880989|NCT01145625|P2|Participant Flow|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
880990|NCT01145625|P1|Participant Flow|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
880991|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
880992|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
881301|NCT01144286|E2|Reported Event|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
880993|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
880994|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
880995|NCT01145625|O2|Outcome|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
880996|NCT01145625|O1|Outcome|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
880997|NCT01145625|E2|Reported Event|5% MTF|"5% Minoxidil Topical Foam~5% Minoxidil: half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks"
880998|NCT01145625|E1|Reported Event|2% MTS|"2% Minoxidil Topical Solution~2% Minoxidil: one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks"
880999|NCT01145560|B4|Baseline|Total|Total of all reporting groups
881000|NCT01145560|B3|Baseline|Placebo|Saline
881001|NCT01145560|B2|Baseline|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
881002|NCT01145560|B1|Baseline|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
881003|NCT01145560|P3|Participant Flow|Placebo|Saline
881004|NCT01145560|P2|Participant Flow|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
881005|NCT01145560|P1|Participant Flow|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
881006|NCT01145560|O3|Outcome|Placebo|Saline
881007|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
881008|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
881009|NCT01145560|O3|Outcome|Placebo|Saline
881010|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
881011|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
881012|NCT01145560|O3|Outcome|Placebo|Saline
881013|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
881014|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
881015|NCT01145560|O3|Outcome|Placebo|Saline
881016|NCT01145560|O2|Outcome|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
881017|NCT01145560|O1|Outcome|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
881018|NCT01145560|E3|Reported Event|Placebo|Saline
881019|NCT01145560|E2|Reported Event|AZD9773 500/100 Units/kg|AZD9773 500/100 units/kg IV
881020|NCT01145560|E1|Reported Event|AZD9773 250/50 Units/kg|AZD9773 250/50 units/kg IV
881021|NCT01145547|B1|Baseline|All Study Participants|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index and in one experiment, both meals had a high Glycemic Index.~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
881022|NCT01145547|P2|Participant Flow|High Glycemic Index, Low Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with high glycemic index followed by a second study consuming meals with a low glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
881023|NCT01145547|P1|Participant Flow|Low Glycemic Index, High Glycemic Index|"Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In this arm, subjects completed the first study consuming meals with low glycemic index followed by a second study consuming meals with a high glycemic index~Dexcom Seven® Plus Continuous Glucose Monitoring sensor: A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject."
881024|NCT01145547|O2|Outcome|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
881025|NCT01145547|O1|Outcome|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
881026|NCT01145547|E2|Reported Event|High Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a high Glycemic Index.
881027|NCT01145547|E1|Reported Event|Low Glycemic Index Effect on Post-prandial Peak|Seven adult subjects with type 1 diabetes participated in two experiments, each consisting of two meals each. In one experiment, both meals had a low Glycemic Index.
881028|NCT01145508|B3|Baseline|Total|Total of all reporting groups
881029|NCT01145508|B2|Baseline|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
881030|NCT01145508|B1|Baseline|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
881031|NCT01145508|P2|Participant Flow|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
881071|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881032|NCT01145508|P1|Participant Flow|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
881033|NCT01145508|O2|Outcome|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
881034|NCT01145508|O1|Outcome|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
881035|NCT01145508|E2|Reported Event|Arm B (Chemotherapy)|"Patients receive docetaxel IV over 1 hour on day 1 and prednisone PO twice daily on days 1-21. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~prednisone: Given PO"
881036|NCT01145508|E1|Reported Event|Arm A (Vaccine and Chemotherapy)|"Patients receive vaccinia-PSA(L155)-TRICOM vaccine subcutaneously (SC) on day 1 and fowlpox-PSA(L155)-TRICOM vaccine SC on days 15, 29, 43, and 57. Beginning on day 85, patients receive chemotherapy in a 21-day cycle. Docetaxel is administered intravenously (IV) over 1 hour on day 1. Prednisone is given orally (PO) twice daily on days 1-21. Treatment with docetaxel and prednisone repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~PSA-TRICOM vaccine: Given SC~fowlpox-PSA-TRICOM vaccine: Given SC~docetaxel: Given IV~prednisone: Given PO"
881037|NCT01145495|B1|Baseline|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
881038|NCT01145495|P1|Participant Flow|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~>~> rituximab: Given IV~>~> lenalidomide: Given orally"
881039|NCT01145495|O1|Outcome|Treatment (Lenalidomide, Rituximab)|"Patients receive oral lenalidomide (20mg) once daily on days 1-21. Treatment with lenalidomide repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity. Patients also receive rituximab (375mg/m^2) IV in weeks 1, 2, 3, 4, 12, 20, 28, and 36 in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~lenalidomide: Given orally"
881040|NCT01145495|E1|Reported Event|Treatment (Lenalidomide, Rituximab)|lenalidomide: Given orally
881041|NCT01145482|B3|Baseline|Total|Total of all reporting groups
881042|NCT01145482|B2|Baseline|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin administered once daily on two occasions
881043|NCT01145482|B1|Baseline|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline administered once daily on two occasions
881044|NCT01145482|P2|Participant Flow|Saline First, Then Insulin|200 micro liters of saline was administered once daily on two occasions followed by 20 IU of insulin once daily on two occasions
881045|NCT01145482|P1|Participant Flow|Insulin First, Then Saline|20 IU of insulin was administered once daily on two occasions followed by 200 micro liters of saline once daily on two occasions
881046|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
881047|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
881048|NCT01145482|O2|Outcome|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
881049|NCT01145482|O1|Outcome|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
881050|NCT01145482|E2|Reported Event|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
881051|NCT01145482|E1|Reported Event|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
881052|NCT01145417|B3|Baseline|Total|Total of all reporting groups
881053|NCT01145417|B2|Baseline|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881054|NCT01145417|B1|Baseline|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881184|NCT01144715|B2|Baseline|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
881055|NCT01145417|P2|Participant Flow|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881056|NCT01145417|P1|Participant Flow|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881057|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881058|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881059|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881060|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881061|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881062|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881063|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881064|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881065|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881066|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881067|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881068|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881069|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881070|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881113|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881288|NCT01144286|P3|Participant Flow|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
881072|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881073|NCT01145417|O2|Outcome|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881074|NCT01145417|O1|Outcome|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881075|NCT01145417|E2|Reported Event|Placebo-Pregabalin|Participants who received placebo matched to pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 mg orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881076|NCT01145417|E1|Reported Event|Pregabalin-Pregabalin|Participants who received pregabalin during double-blind trial A0081244 (NCT01049217), received pregabalin capsule at a starting dose of 75 milligram (mg) orally twice daily, dose adjusted for optimizing pain control based on investigators discretion to allow maximum total dose of 300 mg twice daily for 6 months. Participants underwent an end-of-study medication taper over a 1-week period.
881077|NCT01145391|B3|Baseline|Total|Total of all reporting groups
881078|NCT01145391|B2|Baseline|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
881079|NCT01145391|B1|Baseline|Control|Patients receive usual care.
881080|NCT01145391|P2|Participant Flow|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
881081|NCT01145391|P1|Participant Flow|Control|Patients receive usual care.
881082|NCT01145391|O2|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
881083|NCT01145391|O1|Outcome|Control|Patients receive usual care.
881084|NCT01145391|O2|Outcome|Usual Care|Usual care
881085|NCT01145391|O1|Outcome|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
881086|NCT01145391|E2|Reported Event|Intervention|An outreach coordinator raised patient and provider awareness of unmet BP goals, arranged BP-focused clinic visits, and furnished providers with treatment decision support.
881087|NCT01145391|E1|Reported Event|Control|Patients receive usual care.
881088|NCT01144624|B4|Baseline|Total|Total of all reporting groups
881089|NCT01144624|B3|Baseline|Placebo|Saline
881090|NCT01144624|B2|Baseline|Dose Cohort 2|AZD9773 500/100 units/kg IV
881091|NCT01144624|B1|Baseline|Dose Cohort 1|AZD9773 250/50 units/kg IV
881092|NCT01144624|P3|Participant Flow|Placebo|Saline
881093|NCT01144624|P2|Participant Flow|Dose Cohort 2|AZD9773 500/100 units/kg IV
881094|NCT01144624|P1|Participant Flow|Dose Cohort 1|AZD9773 250/50 units/kg IV
881095|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
881096|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
881097|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
881098|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
881099|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
881100|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
881101|NCT01144624|O3|Outcome|Arm 3 - Placebo|Saline
881102|NCT01144624|O2|Outcome|Arm 2 - Dose Cohort 2|AZD9773 500/100 units/kg IV
881103|NCT01144624|O1|Outcome|Arm 1 - Dose Cohort 1|AZD9773 250/50 units/kg IV
881104|NCT01144624|E3|Reported Event|Placebo|Saline
881105|NCT01144624|E2|Reported Event|Dose Cohort 2|AZD9773 500/100 units/kg IV
881106|NCT01144624|E1|Reported Event|Dose Cohort 1|AZD9773 250/50 units/kg IV
881107|NCT01144598|B1|Baseline|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881108|NCT01144598|P1|Participant Flow|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881109|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881110|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881111|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881112|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881182|NCT01144949|E1|Reported Event|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881114|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881115|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881116|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881117|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881118|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881119|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881120|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881121|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881122|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881123|NCT01144598|O1|Outcome|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881124|NCT01144598|E1|Reported Event|Turkish Patients With Rheumatoid Arthritis|Patients diagnosed with rheumatoid arthritis who had received at least one disease-modifying anti-rheumatic drug, who are already employed at a paid work and able to provide disease history data.
881125|NCT01145352|B1|Baseline|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881126|NCT01145352|P1|Participant Flow|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881127|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881128|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881129|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881130|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881131|NCT01145352|O1|Outcome|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881132|NCT01145352|E1|Reported Event|Etanercept (Genetical Recombination)|Participants with polyarticular juvenile idiopathic arthritis (JIA) who received 10 mg or 25 mg lyophilized etanercept (genetical recombination) for subcutaneous injection.
881133|NCT01145053|B1|Baseline|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881134|NCT01145053|P1|Participant Flow|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881135|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881136|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881137|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881138|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881139|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881140|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881141|NCT01145053|O1|Outcome|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881142|NCT01145053|E1|Reported Event|Spiriva Respimat|Spiriva 2.5 mcg Respimat 60 puffs
881143|NCT01145001|B5|Baseline|Total|Total of all reporting groups
881144|NCT01145001|B4|Baseline|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
881145|NCT01145001|B3|Baseline|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
881146|NCT01145001|B2|Baseline|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881147|NCT01145001|B1|Baseline|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881183|NCT01144715|B3|Baseline|Total|Total of all reporting groups
881148|NCT01145001|P4|Participant Flow|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
881149|NCT01145001|P3|Participant Flow|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
881150|NCT01145001|P2|Participant Flow|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881151|NCT01145001|P1|Participant Flow|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881152|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
881153|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
881154|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881155|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881156|NCT01145001|O4|Outcome|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
881157|NCT01145001|O3|Outcome|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
881158|NCT01145001|O2|Outcome|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881159|NCT01145001|O1|Outcome|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881160|NCT01145001|E4|Reported Event|Placebo Patch and no Contingency Management|"Subjects in this group will receive a placebo patch and will not receive contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects"
881161|NCT01145001|E3|Reported Event|Placebo Patch and Contingency Management|"Subjects in this group will receive a placebo transdermal patch and contingency management~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis"
881162|NCT01145001|E2|Reported Event|Nicotine Patch With no Contingency Management|"Subjects in this group will receive active nicotine patch without contingency management for abstinence~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881163|NCT01145001|E1|Reported Event|Active Nicotine Patch and Contingency Management|"Subjects in this group will receive Contingency Management and active nicotine patch~Cognitive Behavioural Therapy: Weekly CBT for all subjects~Contingency Management: incentives given for abstinence based on urine analysis~Nicotine Transdermal Patch: 14mg ir 21mg doses based on weight and #cigs/day"
881164|NCT01144949|B3|Baseline|Total|Total of all reporting groups
881165|NCT01144949|B2|Baseline|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881166|NCT01144949|B1|Baseline|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881167|NCT01144949|P2|Participant Flow|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881168|NCT01144949|P1|Participant Flow|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881169|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881170|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881171|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881172|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881173|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881174|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881175|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881176|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881177|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881178|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881179|NCT01144949|O2|Outcome|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881180|NCT01144949|O1|Outcome|Silodsosin|silodosin: one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
881181|NCT01144949|E2|Reported Event|Placebo|placebo: one placebo capsule orally, once daily, with food for up to 4 weeks
881185|NCT01144715|B1|Baseline|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
881186|NCT01144715|P2|Participant Flow|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
881187|NCT01144715|P1|Participant Flow|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
881188|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
881189|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
881190|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
881191|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
881192|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
881193|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
881194|NCT01144715|O2|Outcome|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
881195|NCT01144715|O1|Outcome|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
881196|NCT01144715|E2|Reported Event|Control|"Self administered home therapy program~Home Therapy Program: Subjects in the control group will be instructed in a self administered home therapy program"
881197|NCT01144715|E1|Reported Event|Hand Mentor Therapy|"Use of the Hand Mentor (TM) Stroke Therapy Device at home for 8 weeks~Hand Mentor (TM) robotic stroke therapy device: The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance."
881198|NCT01144442|B1|Baseline|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
881199|NCT01144442|P1|Participant Flow|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
881200|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
881201|NCT01144442|O1|Outcome|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
881202|NCT01144442|E1|Reported Event|HIPC Treatment|Patients treated with hyperthermic intraperitoneal chemotherapy at first recurrence of disease.
881203|NCT01144416|B3|Baseline|Total|Total of all reporting groups
881302|NCT01144286|E1|Reported Event|Placebo|placebo pessary, single dose
881204|NCT01144416|B2|Baseline|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
881205|NCT01144416|B1|Baseline|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
881206|NCT01144416|P2|Participant Flow|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
881207|NCT01144416|P1|Participant Flow|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
881208|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
881209|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
881210|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
881211|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
881212|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
881213|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recombinant follicle-stimulating hormone (recFSH) from Stimulation Days 1-7
881214|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
881215|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
881216|NCT01144416|O2|Outcome|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of 300 IU recFSH from Stimulation Days 1-7
881217|NCT01144416|O1|Outcome|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
881218|NCT01144416|E4|Reported Event|Daily 300 IU recFSH -Follow-up|Participants who received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
881219|NCT01144416|E3|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962-Follow-up|Participants who received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7 during Intervention Period and became pregnant.
881220|NCT01144416|E2|Reported Event|Daily 300 IU recFSH|Participants received a single injection of placebo SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections of recFSH from Stimulation Days 1-7
881221|NCT01144416|E1|Reported Event|Single Injection of 150 µg SCH 900962/MK-8962|Participants received a single injection of 150 ug SCH 900962 (MK-8962) on Stimulation Day 1 and 7 injections with placebo-recFSH from Stimulation Days 1-7
881222|NCT01144403|B1|Baseline|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
881223|NCT01144403|P1|Participant Flow|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
881224|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
881225|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
881226|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
881227|NCT01144403|O1|Outcome|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy for mantle cell lymphoma. Rituximab infusions were administered concomitantly with regularly prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~cyclophosphamide: as prescribed, 6 cycles~fludarabine: as prescribed, 6 cycles~mitoxantrone: as prescribed, 6 cycles~rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, day 1 of each 28-day cycle, up to 8 cycles"
881228|NCT01144403|E1|Reported Event|Rituximab|"Rituximab, 375 milligram per meter square (mg/m^2) was given intravenously on Day 1 and then every 28 days (+/-7 days) for 6 cycles, followed by 2 consolidated infusions in responders as rituximab induction therapy. Rituximab infusions were administered concomitantly with prescribed chemotherapy i.e., fludarabine, cyclophosphamide and mitoxantrone (maximum 6 cycles).~Cyclophosphamide: as prescribed, 6 cycles~Fludarabine: as prescribed, 6 cycles~Mitoxantrone: as prescribed, 6 cycles~Rituximab [Mabthera/Rituxan]: 375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles"
881229|NCT01144364|B3|Baseline|Total|Total of all reporting groups
881230|NCT01144364|B2|Baseline|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881231|NCT01144364|B1|Baseline|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881232|NCT01144364|P3|Participant Flow|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881233|NCT01144364|P2|Participant Flow|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881234|NCT01144364|P1|Participant Flow|Induction Phase-Immunochemotherapy Rituximab-FND (R-FND)|"Cycles 1 to 4: Participants received rituximab: 375 milligrams per square meter (mg/m^2) intravenously (IV) on Day 1*, fludarabine (F): 25 mg/m^2 IV on Days 2-4*, mitoxantrone (N): 10 mg/m^2 IV on Day 2*, dexamethasone (D) 10 mg IV (total dose) on Days 2-4*. Cycles were repeated every 28 days for a total of 4 cycles.~*In Cycle 1, rituximab was given on Day 8 in order to avoid tumour lysis syndrome. Consequently, in Cycle 1, fludarabine and dexamethasone were given on Days 1, 2, and 3. Mitoxantrone was given on Day 1."
881235|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881236|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881289|NCT01144286|P2|Participant Flow|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
881290|NCT01144286|P1|Participant Flow|Placebo|placebo pessary, single dose
881291|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
881237|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881238|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881239|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no treatment (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881240|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881241|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881242|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881243|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881244|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881292|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
881293|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
881294|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
881295|NCT01144286|O4|Outcome|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
881245|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881246|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881247|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881248|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881249|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881250|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881251|NCT01144364|O1|Outcome|Rituximab Induction|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received either no therapy (observation) or rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881252|NCT01144364|O2|Outcome|Rituximab Induction, Observation Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881296|NCT01144286|O3|Outcome|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
881297|NCT01144286|O2|Outcome|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
881298|NCT01144286|O1|Outcome|Placebo|placebo pessary, single dose
881299|NCT01144286|E4|Reported Event|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
881300|NCT01144286|E3|Reported Event|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
881253|NCT01144364|O1|Outcome|Rituximab Induction, Rituximab Maintenance|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881254|NCT01144364|E3|Reported Event|Rituximab Induction, Observation Maintenance (Follow-up Phase)|"Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: no further therapy, observation only."
881255|NCT01144364|E2|Reported Event|Rituximab Induction, Rituximab Maintenance (Follow-up Phase)|"Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses).~Maintenance Phase: 3 months after induction treatment (Month 9), participants who showed at least a partial response after induction treatment received rituximab 375 mg/m^2 IV on Day 1. Doses were repeated every 2 months for a total of 4 doses."
881256|NCT01144364|E1|Reported Event|Rituximab Induction (Induction Phase Only)|"Rituximab Induction, Rituximab Maintenance Induction Phase Cycle 1 (4-week cycle): Participants received mitoxantrone 10 mg/m^2 IV on Day 1, fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 1-3, and rituximab 375 mg/m^2 on Day 8.~Induction Phase Cycles 2-4 (4-week cycle): Participants received rituximab 375 mg/m^2 IV on Day 1, mitoxantrone 10 mg/m^2 IV on Day 2, and fludarabine 25 mg/m^2 IV and dexamethasone 10 mg IV on Days 2-4.~One month after completion of the above 4 cycles, participants were evaluated for tumor response (clinical and molecular evaluation). Responding participants (no progressive disease) received rituximab 375 mg/m^2 IV once weekly for a total of 4 weeks (4 total doses)."
881257|NCT01144299|B3|Baseline|Total|Total of all reporting groups
881258|NCT01144299|B2|Baseline|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881259|NCT01144299|B1|Baseline|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881260|NCT01144299|P2|Participant Flow|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881261|NCT01144299|P1|Participant Flow|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881262|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881263|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881264|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881265|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881266|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881267|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881268|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881269|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881270|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881271|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881272|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881273|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881274|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881275|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881276|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881277|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881278|NCT01144299|O2|Outcome|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881279|NCT01144299|O1|Outcome|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881280|NCT01144299|E2|Reported Event|Fluarix Elderly Group|Subjects aged > 60 years received one dose of Fluarix™.
881281|NCT01144299|E1|Reported Event|Fluarix Adult Group|Subjects aged 18 to 60 years received one dose of Fluarix™.
881282|NCT01144286|B5|Baseline|Total|Total of all reporting groups
881283|NCT01144286|B4|Baseline|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
881284|NCT01144286|B3|Baseline|Arasertaconazole Nitrate 300 mg|Arasertaconazole nitrate 300 mg pessary, single dose
881285|NCT01144286|B2|Baseline|Arasertaconazole Nitrate 150 mg|Arasertaconazole nitrate 150 mg pessary, single dose
881286|NCT01144286|B1|Baseline|Placebo|placebo pessary, single dose
881287|NCT01144286|P4|Participant Flow|Arasertaconazole 600 mg|Arasertaconazole nitrate 600 mg pessary, single dose
881303|NCT01144182|B3|Baseline|Total|Total of all reporting groups
881304|NCT01144182|B2|Baseline|Comprehensive Quality Improvement Program (QIP)|Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
881305|NCT01144182|B1|Baseline|Current Best Practice (CBP)|Current best practice (CBP) receives the current treatment for patients discharged with heart failure
881306|NCT01144182|P2|Participant Flow|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881307|NCT01144182|P1|Participant Flow|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881308|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881309|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881310|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881311|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881312|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881313|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881314|NCT01144182|O2|Outcome|Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881315|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881316|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881317|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881318|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881319|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881320|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881321|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881345|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881452|NCT01143727|P2|Participant Flow|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
892162|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
881322|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881323|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881324|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881325|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881326|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881327|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881328|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881329|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881330|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881331|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881332|NCT01144182|O2|Outcome|Comprehensive Quality Improvement Program (QIP)|"Comprehensive quality improvement program (QIP)~Comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881333|NCT01144182|O1|Outcome|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881334|NCT01144182|E2|Reported Event|Quality Improvement Program (QIP)|"Quality improvement program (QIP)~The comprehensive quality improvement program (QIP): Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients."
881335|NCT01144182|E1|Reported Event|Current Best Practice (CBP)|CBP received no intervention and only current best practices for inpatient HF care.
881336|NCT01144052|B3|Baseline|Total|Total of all reporting groups
881337|NCT01144052|B2|Baseline|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881338|NCT01144052|B1|Baseline|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
881339|NCT01144052|P2|Participant Flow|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881340|NCT01144052|P1|Participant Flow|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
881341|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881342|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
881343|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881344|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
881346|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
881347|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day~interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
881348|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.~Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
881349|NCT01144052|O2|Outcome|Interferon-beta-1b|"250 mcg (8 MIU) subcutaneous injections every other day~interferon beta-1b: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])"
881350|NCT01144052|O1|Outcome|Natalizumab|"Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.~Natalizumab: Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions."
881351|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881352|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
881353|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881354|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
881355|NCT01144052|O2|Outcome|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881356|NCT01144052|O1|Outcome|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
881357|NCT01144052|E2|Reported Event|Interferon-beta-1b|250 mcg (8 MIU) subcutaneous injections every other day
881358|NCT01144052|E1|Reported Event|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers’ instructions.
881359|NCT01144026|B3|Baseline|Total|Total of all reporting groups
881360|NCT01144026|B2|Baseline|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
881361|NCT01144026|B1|Baseline|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
881362|NCT01144026|P2|Participant Flow|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
881363|NCT01144026|P1|Participant Flow|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
881364|NCT01144026|O2|Outcome|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
881365|NCT01144026|O1|Outcome|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
881366|NCT01144026|E2|Reported Event|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
881367|NCT01144026|E1|Reported Event|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
881368|NCT01143896|B3|Baseline|Total|Total of all reporting groups
881369|NCT01143896|B2|Baseline|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881370|NCT01143896|B1|Baseline|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
881371|NCT01143896|P2|Participant Flow|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881416|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881566|NCT01143402|B3|Baseline|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
881372|NCT01143896|P1|Participant Flow|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
881373|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881374|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
881375|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881376|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
881377|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881378|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
881379|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881380|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
881381|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881382|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care model: The depression collaborative care arm will include a stepped-care model. The five steps are expected to include symptom and self-management monitoring by depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM will provide education about depression and depression treatment options, assess the patient's treatment preferences and barriers, assess the patient's current depression severity and mental health comorbidity, initiate a self-management plan, and assess treatment adherence. The DCM will use the alcohol screening and brief intervention. The DCM will also screen for street drug use and will recommend referral of participants who are using street drugs to the local substance abuse treatment programs.
881383|NCT01143896|O2|Outcome|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881417|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881562|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
881384|NCT01143896|O1|Outcome|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
881385|NCT01143896|E2|Reported Event|Arm 2: Usual Care|Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The depression collaborative care team will not be a part of the usual care condition.
881386|NCT01143896|E1|Reported Event|Arm 1: Depression Collaborative Care|Depression collaborative care: includes a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
881387|NCT01143883|B3|Baseline|Total|Total of all reporting groups
881388|NCT01143883|B2|Baseline|Standard of Care Dressing|55
881389|NCT01143883|B1|Baseline|Silverlon Dressing|55
881390|NCT01143883|P2|Participant Flow|Standard of Care Dressing|The standard plain gauze is used to dress the wound postoperatively
881391|NCT01143883|P1|Participant Flow|Silverlon Dressing|The Silverlon(Cura Surgical, Geneva, IL) dressing is applied to the surgical wound postoperatively. This dressing is coated with silver nylon.
881392|NCT01143883|O2|Outcome|Standard of Care Dressing|55
881393|NCT01143883|O1|Outcome|Silverlon Dressing|55
881394|NCT01143883|E2|Reported Event|Standard of Care Dressing|55
881395|NCT01143883|E1|Reported Event|Silverlon Dressing|55
881396|NCT01143818|B1|Baseline|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
881397|NCT01143818|P1|Participant Flow|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
881398|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
881399|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
881400|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
881401|NCT01143818|O1|Outcome|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
881402|NCT01143818|E1|Reported Event|AndroGel (Testosterone Gel) 1%|Topical testosterone gel 1% (1 sachet of 5 g contains 50 mg of testosterone), 1 daily dose. All participants who received at least 1 dose of study drug are included in the safety analysis set.
881403|NCT01143792|B4|Baseline|Total|Total of all reporting groups
881404|NCT01143792|B3|Baseline|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
881405|NCT01143792|B2|Baseline|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
881406|NCT01143792|B1|Baseline|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
881407|NCT01143792|P3|Participant Flow|Case Management + HIV Prevention|Description of CM: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
881408|NCT01143792|P2|Participant Flow|MET + HIV Prevention|Description of MET: Treatment included two 1-hour sessions in addition to two HIV prevention sessions.
881409|NCT01143792|P1|Participant Flow|CRA + HIV Prevention|Description of CRA: Treatment included twelve 1-hour sessions in addition to two HIV prevention sessions.
881410|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
881411|NCT01143792|O2|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
881412|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
881413|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
881414|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
881415|NCT01143792|O1|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included int he analysis.
881418|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881419|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881420|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881421|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881422|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881423|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881424|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881425|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881426|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881427|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881428|NCT01143792|O3|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881429|NCT01143792|O2|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881430|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881431|NCT01143792|O3|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881432|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881433|NCT01143792|O1|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. All available data were included in the analysis.
881434|NCT01143792|O3|Outcome|Case Management + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
881435|NCT01143792|O2|Outcome|CRA + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews. the groups equally.
881436|NCT01143792|O1|Outcome|MET + HIV Prevention|The number of participants does not correspond to the participant flow model because some participants did not complete all follow-up assessment interviews.
881437|NCT01143792|E3|Reported Event|Case Management + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
881438|NCT01143792|E2|Reported Event|MET + HIV Prevention|Treatment included two 1-hour MI sessions for a total of 4 sessions
881439|NCT01143792|E1|Reported Event|CRA + HIV Prevention|Treatment included twelve 1-hour sessions for a total of 14 sessions.
881440|NCT01143766|B3|Baseline|Total|Total of all reporting groups
881441|NCT01143766|B2|Baseline|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
881442|NCT01143766|B1|Baseline|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
881443|NCT01143766|P2|Participant Flow|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
881444|NCT01143766|P1|Participant Flow|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
881445|NCT01143766|O2|Outcome|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
881446|NCT01143766|O1|Outcome|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
881447|NCT01143766|E2|Reported Event|Gapabentin|Patients will receive gabapentin 900mg PO x 1 dose, one hour prior to the procedure. At the time of ERCP, patients will be sedated in a standard fashion.
881448|NCT01143766|E1|Reported Event|Standard Sedation|Patients will receive combination opiate and benzodiazepine for sedation, the current standard of care.
881449|NCT01143727|B3|Baseline|Total|Total of all reporting groups
881450|NCT01143727|B2|Baseline|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
881451|NCT01143727|B1|Baseline|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
881453|NCT01143727|P1|Participant Flow|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
881454|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
881455|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
881456|NCT01143727|O2|Outcome|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
881457|NCT01143727|O1|Outcome|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
881458|NCT01143727|E2|Reported Event|Control|"Tegaderm Hydrogel~Tegaderm Hydrogel : Applied once every 24-hr period sufficient to cover the wound."
881459|NCT01143727|E1|Reported Event|Collagenase Santyl Ointment|"Santyl~Santyl : Applied once every 24-hr period sufficient to cover the wound."
881460|NCT01143714|B3|Baseline|Total|Total of all reporting groups
881461|NCT01143714|B2|Baseline|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881462|NCT01143714|B1|Baseline|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881463|NCT01143714|P2|Participant Flow|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881464|NCT01143714|P1|Participant Flow|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881465|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881466|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881467|NCT01143714|O2|Outcome|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881468|NCT01143714|O1|Outcome|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881469|NCT01143714|E2|Reported Event|Vehicle (White Petrolatum)|White Petrolatum : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881470|NCT01143714|E1|Reported Event|Collagenase Santyl Ointment|Santyl : Applied an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
881471|NCT01143701|B3|Baseline|Total|Total of all reporting groups
881472|NCT01143701|B2|Baseline|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
881473|NCT01143701|B1|Baseline|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
881474|NCT01143701|P2|Participant Flow|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
881475|NCT01143701|P1|Participant Flow|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics ADHD guidelines."
881476|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
881477|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
881478|NCT01143701|O2|Outcome|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
881479|NCT01143701|O1|Outcome|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
881480|NCT01143701|E2|Reported Event|Typical ADHD Care|Physicians in this group will provide typical ADHD care.
881481|NCT01143701|E1|Reported Event|ADHD Collaborative Intervention|"The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.~ADHD Collaborative: The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines."
881482|NCT01143688|B1|Baseline|Overall Study|
881563|NCT01143610|E2|Reported Event|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
881564|NCT01143610|E1|Reported Event|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
881483|NCT01143688|P1|Participant Flow|All Study Participants|Each study participant was randomized to a specific random sequence of interventions for visits 1-4 (e.g. first inhaled bronchodilator, then inhaled placebo, then sham acupuncture, then no intervention administered 3-7 days apart, or first sham acupuncture, then inhaled bronchodilator, then no intervention, then inhaled placebo administered 3-7 days apart, or any other combination of these four interventions in any order). This process was repeated for visits 5-8 and again for visits 9-12.
881484|NCT01143688|O4|Outcome|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
881485|NCT01143688|O3|Outcome|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
881486|NCT01143688|O2|Outcome|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
881487|NCT01143688|O1|Outcome|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
881488|NCT01143688|O4|Outcome|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
881489|NCT01143688|O3|Outcome|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
881490|NCT01143688|O2|Outcome|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
881491|NCT01143688|O1|Outcome|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
881492|NCT01143688|E4|Reported Event|No-intervention Control|"Subjects will be instructed that they will receive no interventions on this visit.~Spirometry will be obtained every 20 minutes for maximal FEV1 for 120 minutes. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
881493|NCT01143688|E3|Reported Event|Placebo Acupuncture|Subjects will be instructed that they will receive one of three different acupuncture point combinations that may or may not be effective for asthma. Placebo acupuncture will be performed with a validated acupuncture device that allows patients to see an acupuncture needle enter their skin and actually feel the sensation of penetration. The needle penetrates up the needle shaft and never penetrates the point. The needle has been validated and shown to be indistinguishable from real acupuncture.
881494|NCT01143688|E2|Reported Event|Placebo Inhaler|Subjects will be shown an unmarked metered-dose inhaler similar to that used for bronchodilator testing. This placebo inhaler contains only propellant and inert ingredients (trichlorofluoromethane and dichlorodifluoromethane with lecithin). The subjects will be reminded that this inhaler may contain either albuterol or placebo. They will then inhale 4 puffs of the placebo inhaler containing only the propellant vehicle through a spacer. Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area.
881521|NCT01143636|B3|Baseline|Active tDCS&Sham tDCS - Healthy Controls|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
881495|NCT01143688|E1|Reported Event|Albuterol Inhaler|"Subjects will perform baseline spirometry. Subsequently subjects will be shown an unmarked metered-dose inhaler device. This inhaler contains active albuterol (90 mcg/puff). The subjects will be reminded that this inhaler may contain either albuterol or placebo, and will complete questionnaires documenting their expectations for improvement in lung function with this treatment. Subsequently subjects will inhale 4 puffs (360 mcg) of albuterol administered from this inhaler via a spacing device.~Spirometry will be obtained every 20 minutes post inhalation and the maximal FEV1 measured over the subsequent 120 minutes will be recorded as the post-intervention response on that visit. In the time period between spirometry, subjects will sit quietly in a separate waiting area."
881496|NCT01143649|B6|Baseline|Total|Total of all reporting groups
881497|NCT01143649|B5|Baseline|tACS Active&Sham - Healthy|active or sham 15Hz-tACS over of the primary motor cortex (M1) bilaterally.
881498|NCT01143649|B4|Baseline|Sham tDCS + CIMT - Healthy|Participants received sham tDCS (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
881499|NCT01143649|B3|Baseline|tDCS Active + CIMT - Healthy|Participants received active (1mA - 40min) of the primary motor cortex (M1) bilaterally combined with unilateral motor training and contralateral hand restraint.
881500|NCT01143649|B2|Baseline|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
881501|NCT01143649|B1|Baseline|tDCS + CIMT - Stroke|"Participants received active tDCS over the primary motor cortex (M1). We used the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects were stimulated at 1 mA for 40 minutes."
881502|NCT01143649|P6|Participant Flow|Healthy Participants - Sham tACS, Then Active|Subjects will receive 20 min of sham and then tACS over the primary motor cortex in a randomized order.
881503|NCT01143649|P5|Participant Flow|Healthy Participants - Active tACS, Then Sham|Subjects will receive 20 min of active then sham tACS over the primary motor cortex in a randomized order.
881504|NCT01143649|P4|Participant Flow|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
881505|NCT01143649|P3|Participant Flow|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
881506|NCT01143649|P2|Participant Flow|Sham tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Sham stimulation consists of 30secondes of stimulation at the beginning of the 40minutes treatment."
881507|NCT01143649|P1|Participant Flow|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
881508|NCT01143649|O2|Outcome|Healthy Participants - Sham tACS|Subjects will receive 20 min of sham tACS
881509|NCT01143649|O1|Outcome|Healthy Participants - Active tACS|Subjects will receive 20 min of active tACS
881510|NCT01143649|O2|Outcome|Healthy Participants: Sham tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of sham tDCS."
881511|NCT01143649|O1|Outcome|Healthy Participants: Active tDCS + Motor Training|"Each stimulation day will include up to six hours of training termed shaping in the non-dominant hand while the dominant hand is restrained in a resting hand splint and secured in a sling. At the start of this training, subjects will undergo 40 minutes of tDCS at 1mA."
881512|NCT01143649|O2|Outcome|Sham tDCS + CIMT|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
881513|NCT01143649|O1|Outcome|tDCS + CIMT|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
881514|NCT01143649|E6|Reported Event|Sham tACS - Healthy|Subjects will undergo 20 minutes of sham tACS.
881515|NCT01143649|E5|Reported Event|Active tACS - Healthy|Subjects will undergo 20 minutes of active tACS.
881516|NCT01143649|E4|Reported Event|Sham tDCS + CIMT - Healthy|subjects will undergo 40 minutes of sham tDCS.
881517|NCT01143649|E3|Reported Event|Active tDCS + CIMT - Healthy|subjects will undergo 40 minutes of tDCS at 1mA.
881518|NCT01143649|E2|Reported Event|Sham tDCS + CIMT - Stroke|Participants received sham tDCS over the primary motor cortex plus CIMT. The same site and parameters of stimulation were employed, but the stimulator was turned off after 30 seconds of stimulation. This ensured that patients could feel the initial itching sensation at the beginning of tDCS.
881519|NCT01143649|E1|Reported Event|tDCS + CIMT - Stroke|"Participants will receive tDCS over the primary motor cortex (M1). We will use the following stimulation parameters: intensity of 1mA and for the first 40 minutes of constraint induced movement therapy (CIMT- 10 consecutive sessions Monday- Friday).~Transcranial Stimulation: Subjects will be stimulated at 1 mA for 40 minutes."
881520|NCT01143636|B4|Baseline|Total|Total of all reporting groups
881558|NCT01143610|P1|Participant Flow|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
881559|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
881522|NCT01143636|B2|Baseline|Sham tDCS - Pelvic Pain|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881523|NCT01143636|B1|Baseline|Active tDCS - Pelvic Pain|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881524|NCT01143636|P4|Participant Flow|Healthy Subjects: Sham tDCS/Active tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
881525|NCT01143636|P3|Participant Flow|Healthy Controls: Active tDCS/Sham tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
881526|NCT01143636|P2|Participant Flow|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881527|NCT01143636|P1|Participant Flow|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881528|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881529|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881530|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881531|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881532|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881533|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881534|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881535|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881536|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881537|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881560|NCT01143610|O1|Outcome|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
881561|NCT01143610|O2|Outcome|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
881565|NCT01143402|B4|Baseline|Total|Total of all reporting groups
881538|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881539|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881540|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881541|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881542|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881543|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881544|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881545|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881546|NCT01143636|O2|Outcome|Healthy Subjects: Sham tDCS|Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
881547|NCT01143636|O1|Outcome|Healthy Controls: Active tDCS|Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period.
881548|NCT01143636|O2|Outcome|Pelvic Pain, Sham tDCS|Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA.
881549|NCT01143636|O1|Outcome|Pelvic Pain, Active tDCS|Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes.
881550|NCT01143636|E4|Reported Event|ACTIVE tDCS - Sham|"ACTIVE tDCS: Subjects will receive a single session of active tDCS. The anode electrode will be placed on the primary motor cortex.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
881551|NCT01143636|E3|Reported Event|SHAM tDCS - Healthy|"SHAM tDCS: Subjects will receive a single session of sham tDCS. The anode electrode will be placed on the primary motor cortex.~For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
881552|NCT01143636|E2|Reported Event|ACTIVE tDCS - Pelvic Pain Patients|"ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
881553|NCT01143636|E1|Reported Event|SHAM tDCS - Pelvic Pain Patients|"SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side.~For sham-controlled tDCS subjects, the current will be applied only for 30 seconds.~Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes."
881554|NCT01143610|B3|Baseline|Total|Total of all reporting groups
881555|NCT01143610|B2|Baseline|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
881556|NCT01143610|B1|Baseline|Newly Forming Bone|Miller class I or II deep recessions treated by the newly forming bone technique.
881557|NCT01143610|P2|Participant Flow|Subepithelial Connective Tissue Graft|Miller class I or II deep recessions treated by subepithelial connective tissue graft.
892163|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
881567|NCT01143402|B2|Baseline|Arm II (Selumetinib)|Randomized to Selumetinib
881568|NCT01143402|B1|Baseline|Arm I (Temozolomide)|Randomized to Temozolomide
881569|NCT01143402|P3|Participant Flow|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
881570|NCT01143402|P2|Participant Flow|Arm II (Selumetinib)|Randomized to Selumetinib
881571|NCT01143402|P1|Participant Flow|Arm I (Temozolomide)|Randomized to Temozolomide
881572|NCT01143402|O2|Outcome|Arm II (Selumetinib)|Randomized to Selumetinib
881573|NCT01143402|O1|Outcome|Arm I (Temozolomide)|Randomized to Temozolomide
881574|NCT01143402|O2|Outcome|Arm II (Selumetinib)|Randomized to Selumetinib
881575|NCT01143402|O1|Outcome|Arm I (Temozolomide)|Randomized to Temozolomide
881576|NCT01143402|E3|Reported Event|Non-Randomized (Selumetinib)|Non-Randomized to Selumetinib
881577|NCT01143402|E2|Reported Event|Arm II (Selumetinib)|Randomized to Selumetinib
881578|NCT01143402|E1|Reported Event|Arm I (Temozolomide)|Randomized to Temozolomide
881579|NCT01143337|B3|Baseline|Total|Total of all reporting groups
881580|NCT01143337|B2|Baseline|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
881581|NCT01143337|B1|Baseline|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881582|NCT01143337|P3|Participant Flow|MP-435 400mg BID|MP-435 400mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
881583|NCT01143337|P2|Participant Flow|MP-435 100mg BID|MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.
881584|NCT01143337|P1|Participant Flow|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881585|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
881586|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881587|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
881588|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881589|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
881590|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881591|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
881592|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881593|NCT01143337|O2|Outcome|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
881594|NCT01143337|O1|Outcome|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881623|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881595|NCT01143337|E2|Reported Event|MP-435 100mg BID|"MP-435 100mg, orally, twice daily. And stable dose (6-8 mg/week) MTX were administered as background therapy.~MP-435 400mg:~There were 13 patients who randomized 400 mg bid group when they were discontinued dosing. At this point, it was found that there were Four patients who increased ALT more than three times of upper limit of normal in this dosing group. Therefore, patients who randomized to this dosing group were discontinued and also new inclusion was stopped in this point.~Primary analysis of this study result was Par Protocol Set ( PPS ). Because examination for 400 mg bid group was discontinued, this arm data was excluded from PPS analysis."
881596|NCT01143337|E1|Reported Event|Placebo|MP-435 placebo-matching tablets, orally, twice daily. And stable dose (6-8 mg/week) Methotrexate(MTX) were administered as background therapy.
881597|NCT01143324|B1|Baseline|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881598|NCT01143324|P1|Participant Flow|MAST™ Procedure|Single Arm Study with MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881599|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881600|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881601|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881602|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881603|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881604|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881605|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881606|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881607|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881608|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881609|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881610|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881611|NCT01143324|O1|Outcome|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881612|NCT01143324|E1|Reported Event|MAST™ Procedure|MAST™ procedure: Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
881613|NCT01143272|B3|Baseline|Total|Total of all reporting groups
881614|NCT01143272|B2|Baseline|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881615|NCT01143272|B1|Baseline|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881616|NCT01143272|P2|Participant Flow|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881617|NCT01143272|P1|Participant Flow|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881618|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881619|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881620|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881621|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881622|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881651|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881624|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881625|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881626|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881627|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881628|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881629|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881630|NCT01143272|O2|Outcome|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881631|NCT01143272|O1|Outcome|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881632|NCT01143272|E2|Reported Event|Microcristallin Cellulose|"Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Placebo: Placebo"
881633|NCT01143272|E1|Reported Event|Saccharomyces Boulardii|"Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation~Saccharomyces boulardii: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule"
881634|NCT01143259|B3|Baseline|Total|Total of all reporting groups
881635|NCT01143259|B2|Baseline|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
881636|NCT01143259|B1|Baseline|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
881637|NCT01143259|P2|Participant Flow|Alvimopan|Treatment Group : The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
881638|NCT01143259|P1|Participant Flow|300 mg Polyethylene|Control Group : The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
881639|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
881640|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
881641|NCT01143259|O2|Outcome|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
881642|NCT01143259|O1|Outcome|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
881643|NCT01143259|E2|Reported Event|Alvimopan|Treatment Group: The treatment group will receive 12mg of Alvimopan by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
881644|NCT01143259|E1|Reported Event|300 mg Polyethylene|Control Group: The control group will receive 300mg of polyethylene glyco by mouth 30 to 300 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
881645|NCT01143207|B1|Baseline|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881646|NCT01143207|P1|Participant Flow|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881647|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881648|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881649|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881650|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
892164|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
881652|NCT01143207|O1|Outcome|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881653|NCT01143207|E1|Reported Event|Medroxyprogesterone Acetate|"Single injection of Medroxyprogesterone acetate (hormonal contraceptive)~Medroxyprogesterone acetate : Injectable hormonal contraceptive"
881654|NCT01143142|B3|Baseline|Total|Total of all reporting groups
881655|NCT01143142|B2|Baseline|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881656|NCT01143142|B1|Baseline|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881657|NCT01143142|P2|Participant Flow|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881658|NCT01143142|P1|Participant Flow|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881659|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881660|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881661|NCT01143142|O2|Outcome|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881662|NCT01143142|O1|Outcome|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881663|NCT01143142|E2|Reported Event|Untailored Information|"Individuals assigned to the control group will receive the CDC vaccine information sheet that is standardly provided.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881664|NCT01143142|E1|Reported Event|Tailoring|"Individuals assigned to the experimental group will receive a two-page brochure tailored based on their responses to the survey.~Computer-based tailoring system: Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure."
881665|NCT01143090|B1|Baseline|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
881666|NCT01143090|P1|Participant Flow|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study.
881667|NCT01143090|O1|Outcome|Lurasidone Overall|
881668|NCT01143090|E1|Reported Event|Open Label|Subjects will continue on treatment with the same dose of lurasidone - 40 mg to 120 mg taken at endpoint of the D1050289 (NCT01143090) core study. One enrolled subject did not receive any study medication and was excluded from this summary.
881669|NCT01143077|B4|Baseline|Total|Total of all reporting groups
881670|NCT01143077|B3|Baseline|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
881671|NCT01143077|B2|Baseline|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
881672|NCT01143077|B1|Baseline|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
881673|NCT01143077|P3|Participant Flow|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
882617|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
881674|NCT01143077|P2|Participant Flow|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
881675|NCT01143077|P1|Participant Flow|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
881676|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
881677|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
881678|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
881679|NCT01143077|O3|Outcome|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg daily for 14 days followed by flexible dosing between 40 and 120 mg dailly for 4 weeks.
881680|NCT01143077|O2|Outcome|Lurasidone Open-Label Arm 40/80|Lurasidone 40 mg daily for 7 days followed by Lurasidone 80 mg daily for 7 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
881681|NCT01143077|O1|Outcome|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg daily for 14 days followed by flexible dosing between 40 and 120 mg daily for 4 weeks.
881682|NCT01143077|E3|Reported Event|Lurasidone Open-Label Arm 80/80|Lurasidone 80 mg once daily orally for two weeks, followed by Lurasidone 40-120mg once daily for 4 weeks
881683|NCT01143077|E2|Reported Event|Lurasidone Open-Label Arm 40/80|Lurasidone 40mg for 7 days, followed by Lurasidone 80 mg for 7 days, orally once daily, followed by 4 weeks of flexible dosing 40-120mg once daily
881684|NCT01143077|E1|Reported Event|Lurasidone Open-Label Arm 40/40|Lurasidone 40 mg orally once daily for 14 days followed by 4 weeks of flexible dosing 40-120mg
881685|NCT01143051|B7|Baseline|Total|Total of all reporting groups
881686|NCT01143051|B6|Baseline|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
881687|NCT01143051|B5|Baseline|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
881688|NCT01143051|B4|Baseline|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
881689|NCT01143051|B3|Baseline|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
881690|NCT01143051|B2|Baseline|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
881691|NCT01143051|B1|Baseline|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
881692|NCT01143051|P6|Participant Flow|T2, T1, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
881693|NCT01143051|P5|Participant Flow|T2, C, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
881694|NCT01143051|P4|Participant Flow|T1, T2, C|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.
881747|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881748|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881695|NCT01143051|P3|Participant Flow|T1, C, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
881696|NCT01143051|P2|Participant Flow|C, T2, T1|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.
881697|NCT01143051|P1|Participant Flow|C, T1, T2|Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.
881698|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
881699|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
881700|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
881701|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
881702|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
881703|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
881704|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
881705|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
881706|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
881707|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
881708|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
881709|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
881710|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
881711|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
881712|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
881713|NCT01143051|O3|Outcome|Treatment C|Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine
881714|NCT01143051|O2|Outcome|Treatment T2|Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine
881715|NCT01143051|O1|Outcome|Treatment T1|Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine
881716|NCT01143051|E3|Reported Event|Treatment C|"Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.~epinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations"
881717|NCT01143051|E2|Reported Event|Treatment T2|"HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations"
881718|NCT01143051|E1|Reported Event|Treatment T1|"T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation~epinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations"
881719|NCT01143038|B1|Baseline|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881720|NCT01143038|P1|Participant Flow|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881721|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881749|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881722|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881723|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881724|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881725|NCT01143038|O1|Outcome|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881726|NCT01143038|E1|Reported Event|Romiplostim|Participants received romiplostim administered weekly by subcutaneous injection during the 12-month treatment period. The starting dose was 1 μg/kg with weekly dose increases in increments of 1 μg/kg/week to a maximum dose of 10 μg/kg to reach a target platelet count of ≥ 50 x 10^9/L. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L entered the tapering period, during which the romiplostim dose was decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. Participants who had tapered off treatment with romiplostim and whose platelet count dropped below 50 x 10^9/L could reinitiate romiplostim for up to 8 weeks.
881727|NCT01142908|B3|Baseline|Total|Total of all reporting groups
881728|NCT01142908|B2|Baseline|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881729|NCT01142908|B1|Baseline|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881730|NCT01142908|P2|Participant Flow|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881731|NCT01142908|P1|Participant Flow|Pharmacist CVD|The pharmacist cardiovascular (CVD) intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881732|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881733|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881734|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881735|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881736|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881737|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881738|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881739|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881740|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881741|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881742|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881743|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881744|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881745|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881746|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881750|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881751|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881752|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881753|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881754|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881755|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881756|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881757|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881758|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881759|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881760|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881761|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881762|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881763|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881764|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881765|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881766|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881767|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881768|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881769|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881770|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881771|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881772|NCT01142908|O2|Outcome|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881773|NCT01142908|O1|Outcome|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881774|NCT01142908|E2|Reported Event|Education Control|The education control group - these participants will receive educational material about CVD reduction.
881775|NCT01142908|E1|Reported Event|Pharmacist CVD|The pharmacist CVD intervention group - clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
881776|NCT01142726|B4|Baseline|Total|Total of all reporting groups
881777|NCT01142726|B3|Baseline|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881778|NCT01142726|B2|Baseline|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881779|NCT01142726|B1|Baseline|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881780|NCT01142726|P3|Participant Flow|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881781|NCT01142726|P2|Participant Flow|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
882085|NCT01141283|O1|Outcome|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
881782|NCT01142726|P1|Participant Flow|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept subcutaneous (SC) 125 mg/week and MTX.
881783|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881784|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881785|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881786|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881787|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881788|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881789|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881813|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months~Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
892165|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
881790|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881791|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881792|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881793|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881794|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881795|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881796|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881797|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881814|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
881925|NCT01142388|B1|Baseline|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
881798|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881799|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881800|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881801|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881802|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881803|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate (MTX), 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a Low Disease Activity Score (LDAS) defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of rheumatoid arthritis (RA) symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX.
881804|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881805|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881806|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881807|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881808|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881809|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881810|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881811|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881812|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
882086|NCT01141283|E1|Reported Event|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
881815|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
881816|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|"Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months~Abatacept placebo: Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months"
881817|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate placebo: Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months"
881818|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|"Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period~Abatacept: Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months~Methotrexate: Tablets, oral, 2.5 mg, once weekly, 12 months"
881819|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881820|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881821|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881822|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881823|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881824|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881825|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881826|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881827|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881828|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881829|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881830|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881831|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881832|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881833|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881834|NCT01142726|O3|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881835|NCT01142726|O2|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881836|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881837|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881838|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period
881839|NCT01142726|O2|Outcome|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period
881840|NCT01142726|O1|Outcome|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period
881857|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881926|NCT01142388|P2|Participant Flow|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
881841|NCT01142726|E3|Reported Event|Methotrexate, 2.5 mg, Plus Abatacept Placebo|Participants received methotrexate, 2.5 mg, orally as tablets, plus abatacept placebo subcutaneously, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
881842|NCT01142726|E2|Reported Event|Abatacept, 125 mg, Plus Methotrexate Placebo|Participants received abatacept, 125 mg subcutaneously, plus methotrexate placebo tablets orally, once weekly during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC (125 mg/week) and MTX. Safety data was collected from Day 1 to 56 days post last dose.
881843|NCT01142726|E1|Reported Event|Abatacept, 125 mg, Plus Methotrexate, 2.5 mg|Participants received abatacept, 125 mg subcutaneously, plus methotrexate, 2.5 mg orally as tablets, once weekly, during the 12-month Treatment Period. Participants with a LDAS defined as DAS28-CRP score of < 3.2 at Month 12 (end of Treatment Period) entered the Withdrawal Period for up to 12 months, during which all study medication was withdrawn. Participants with a DAS28-CRP score of >3.2 were discontinued from the study. All MTX and corticosteroids, if not already discontinued, were to be tapered off during the first month of the Withdrawal Period. Participants who experienced a worsening of RA symptoms or a RA flare after at least 3 months in the Withdrawal Period were eligible to enroll into a 6-month Re-exposure Period, during which they received open-label treatment with abatacept SC 125 mg/week and MTX. Safety data was collected from Day 1 to 56 days post last dose.
881844|NCT01142661|B1|Baseline|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
881845|NCT01142661|P1|Participant Flow|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
881846|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
881847|NCT01142661|O1|Outcome|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
881848|NCT01142661|E1|Reported Event|Eribulin Mesylate|Eribulin Mesylate : Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
881849|NCT01142596|B3|Baseline|Total|Total of all reporting groups
881850|NCT01142596|B2|Baseline|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881851|NCT01142596|B1|Baseline|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881852|NCT01142596|P2|Participant Flow|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881853|NCT01142596|P1|Participant Flow|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124 (NCT01098110), and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881854|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881855|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881856|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881921|NCT01142466|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
881922|NCT01142466|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881923|NCT01142388|B3|Baseline|Total|Total of all reporting groups
881858|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881859|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881860|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881861|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881862|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881863|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881864|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881865|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881866|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881867|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881868|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881869|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881870|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881871|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881872|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881873|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881874|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881875|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881876|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881877|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881878|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881879|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881880|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881881|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881882|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881883|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881884|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881885|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881886|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881887|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881888|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881889|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881890|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881924|NCT01142388|B2|Baseline|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
882087|NCT01141205|B3|Baseline|Total|Total of all reporting groups
881891|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881892|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881893|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881894|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881895|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881896|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881897|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881898|NCT01142596|O2|Outcome|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881899|NCT01142596|O1|Outcome|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881900|NCT01142596|E2|Reported Event|Asenapine 5/10 mg BID|Participants in this group had received double-blind asenapine 5 or 10 mg BID in preceding study P06124, and continued on same double-blind dose for first 6 weeks of extension study P06125, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881901|NCT01142596|E1|Reported Event|Placebo/Asenapine|Participants in this group had received double-blind placebo BID in preceding study P06124, and continued on same double-blind dose for first 2 weeks of extension study P06125, then took double-blind asenapine 5 mg BID for 4 weeks, after which were re-randomized to open label asenapine 5 or 10 mg BID for 46 weeks. Open label dose could be adjusted using dose options of 5 and 10 mg BID for efficacy and tolerability
881902|NCT01142466|B3|Baseline|Total|Total of all reporting groups
881903|NCT01142466|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
881904|NCT01142466|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881905|NCT01142466|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
881906|NCT01142466|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881907|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
881908|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881909|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
881910|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881911|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
881912|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881913|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
881914|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881915|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
881916|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881917|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
881918|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881919|NCT01142466|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
881920|NCT01142466|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (s.c.) at a dose of 44 microgram (mcg), three times a week.
881927|NCT01142388|P1|Participant Flow|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
881928|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
881929|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
881930|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
881931|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
881932|NCT01142388|O2|Outcome|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
881933|NCT01142388|O1|Outcome|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
881934|NCT01142388|E2|Reported Event|Arm II (Cixutumumab, Paclitaxel)|"Patients receive cixutumumab IV over 1 hour at a dose of 10 mg/kg on days 1 and 15 of every 28 day cycle, and paclitaxel as in Arm I.~cixutumumab: Given IV, administered prior to chemotherapy, doses were based on actual body weight~paclitaxel: Given IV"
881935|NCT01142388|E1|Reported Event|Arm I (Paclitaxel)|"Patients receive paclitaxel IV over 1 hour at a dose of 80 mg/m^2 on days 1, 8, and 15 of every 28 day cycle.~paclitaxel: Given IV"
881936|NCT01142323|B1|Baseline|Fenofibrate|fenofibrate 160 mg po daily
881937|NCT01142323|P1|Participant Flow|Fenofibrate|fenofibrate 160 mg po daily
881938|NCT01142323|O2|Outcome|At 6 Months|fenofibrate 160 mg/day
881939|NCT01142323|O1|Outcome|Baseline|Prior to drug intervention
881940|NCT01142323|E1|Reported Event|Fenofibrate|fenofibrate 160 mg po daily
881941|NCT01142297|B1|Baseline|Dental Implant|"standard SLA surface and chemically modified surface~dental implant : standard SLA surface and modified dental implant : chemically modified surface"
881942|NCT01142297|P1|Participant Flow|Dental Implant|standard SLA surface and chemically-modified surface implant
881943|NCT01142297|O2|Outcome|Modified SLA Minimum ISQ HbA1c<9.5|"chemically modified surface~modified dental implant : chemically modified surface"
881944|NCT01142297|O1|Outcome|SLA Minimum ISQ HbA1c<9.5|"standard SLA surface~dental implant : standard SLA surface"
881945|NCT01142297|E2|Reported Event|Modified Dental Implant|"chemically modified surface~modified dental implant : chemically modified surface"
881946|NCT01142297|E1|Reported Event|Dental Implant|"standard SLA surface~dental implant : standard SLA surface"
881947|NCT01142193|B3|Baseline|Total|Total of all reporting groups
881948|NCT01142193|B2|Baseline|Placebo|Placebo
881949|NCT01142193|B1|Baseline|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881950|NCT01142193|P2|Participant Flow|Placebo|Placebo
881951|NCT01142193|P1|Participant Flow|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881952|NCT01142193|O2|Outcome|Placebo|Placebo
881953|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881954|NCT01142193|O2|Outcome|Placebo|Placebo
881955|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881956|NCT01142193|O2|Outcome|Placebo|Placebo
881957|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881958|NCT01142193|O2|Outcome|Placebo|Placebo
881959|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881960|NCT01142193|O2|Outcome|Placebo|Placebo
881961|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881962|NCT01142193|O2|Outcome|Placebo|Placebo
881963|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881964|NCT01142193|O2|Outcome|Placebo|Placebo
881965|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881966|NCT01142193|O2|Outcome|Placebo|Placebo
881967|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881968|NCT01142193|O2|Outcome|Placebo|Placebo
881969|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881970|NCT01142193|O2|Outcome|Placebo|Placebo
881971|NCT01142193|O1|Outcome|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881972|NCT01142193|E2|Reported Event|Placebo|Placebo
881973|NCT01142193|E1|Reported Event|USL255|Titration of 50 mg in weekly increments over 3 weeks to 200 mg
881974|NCT01142128|B5|Baseline|Total|Total of all reporting groups
881975|NCT01142128|B4|Baseline|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
881976|NCT01142128|B3|Baseline|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
881977|NCT01142128|B2|Baseline|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
881978|NCT01142128|B1|Baseline|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
882017|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
881979|NCT01142128|P1|Participant Flow|All Participants|"Participants received one of four interventions in a randomized crossover design:~Nexium Alone: Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium~Placebo to Nexium, Alone: Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Nexium: Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium~Viokase 16 Plus Placebo to Nexium: Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone"
881980|NCT01142128|O1|Outcome|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
881981|NCT01142128|O1|Outcome|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
881982|NCT01142128|O1|Outcome|Placebo to Nexium, Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
881983|NCT01142128|O1|Outcome|Nexium Alone|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
881984|NCT01142128|E4|Reported Event|Viokase 16 Plus Placebo to Nexium|Viokase 16 is given with a placebo to Nexium for one month to be compared against Viokase 16 plus Nexium, Nexium alone and Placebo to Nexium alone
881985|NCT01142128|E3|Reported Event|Viokase 16 Plus Nexium|Viokase 16 is given with Nexium for one month to be compared against Nexium alone, Placebo to Nexium alone and Viokase 16 plus placebo to Nexium
881986|NCT01142128|E2|Reported Event|Placebo to Nexium, Alone|Placebo to Nexium is given instead of Nexium for one month. This will be compared to the Nexium alone, Viokase 16 plus Nexium and Viokase 16 plus placebo to Nexium
881987|NCT01142128|E1|Reported Event|Nexium Alone|Nexium alone is given for one month to be compared to a placebo to Nexium, Viokase 16 plus Nexium and Viokase 16 plus a placebo to Nexium
881988|NCT01142115|B1|Baseline|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
881989|NCT01142115|P2|Participant Flow|Monza First, Then SpeediCath|Catheterization with Monza catheter on visit 1. Catheterization with SpeediCath catheter on visit 2.
881990|NCT01142115|P1|Participant Flow|SpeediCath First, Then Monza|Catheterization with SpeediCath catheter on visit 1. Catheterization with Monza catheter on visit 2.
881991|NCT01142115|O2|Outcome|SpeediCath|Control Product
881992|NCT01142115|O1|Outcome|Monza|Test product
881993|NCT01142115|O2|Outcome|SpeediCath|Control Product
881994|NCT01142115|O1|Outcome|Monza|Test product
881995|NCT01142115|O2|Outcome|SpeediCath|Control Product
881996|NCT01142115|O1|Outcome|Monza|Test product
881997|NCT01142115|O2|Outcome|SpeediCath|Control Product
881998|NCT01142115|O1|Outcome|Monza|Test product
881999|NCT01142115|O2|Outcome|SpeediCath|Control Product
882000|NCT01142115|O1|Outcome|Monza|Test product
882001|NCT01142115|O2|Outcome|SpeediCath|Control Product
882002|NCT01142115|O1|Outcome|Monza|Test product
882003|NCT01142115|E1|Reported Event|Entire Study Population|Includes groups randomized to receive SpeediCath first and Monza first
882004|NCT01141712|B1|Baseline|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day (BID) on Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882005|NCT01141712|P1|Participant Flow|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 twice a day from Days -5 to -2, Cytarabine 100 mg/m^2 twice a day from Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882006|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882007|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882008|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882009|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882010|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882011|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882012|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882013|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882014|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882015|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882016|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882088|NCT01141205|B2|Baseline|Saline|Saline injection
882018|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882019|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882020|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882021|NCT01141712|O1|Outcome|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882022|NCT01141712|E1|Reported Event|Autologous Transplant|Patients will receive BCNU 300 mg/m^2 Day -6, Etoposide 100 mg/m^2 BID Days -5 to -2, Cytarabine 100 mg/m^2 BID Days -5 to -2, and Melphalan 140 mg/m^2 Day -1 followed by autologous HCT.
882023|NCT01141660|B3|Baseline|Total|Total of all reporting groups
882024|NCT01141660|B2|Baseline|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882025|NCT01141660|B1|Baseline|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882026|NCT01141660|P2|Participant Flow|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882027|NCT01141660|P1|Participant Flow|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882028|NCT01141660|O2|Outcome|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882029|NCT01141660|O1|Outcome|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882030|NCT01141660|E2|Reported Event|Laryngeal Mask Airway|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882031|NCT01141660|E1|Reported Event|Endotracheal Tube|Children undergoing adenotonsillectomy are randomized to endotracheal tube or laryngeal mask airway.
882032|NCT01141647|B1|Baseline|24-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
882033|NCT01141647|P1|Participant Flow|24-Month Supported Employment|Evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
882034|NCT01141647|O2|Outcome|Participants in SCI-VIP Standard Care|Standard Care group from SCI-VIP trial (NCT00117806): Standard care varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
882035|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
882036|NCT01141647|O2|Outcome|Participants in SCI-VIP Standard Care|Standard Care group from SCI-VIP trial (NCT00117806): Standard care varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
882037|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
882038|NCT01141647|O3|Outcome|Late Stage|Interview data from clinical staff in year 3.
882039|NCT01141647|O2|Outcome|Mid Stage|Interview data from clinical staff from year 2.
882040|NCT01141647|O1|Outcome|Early Stage|Interview data from clinical staff during year 1.
882041|NCT01141647|O1|Outcome|48-Month Supported Employment|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
882042|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
882043|NCT01141647|O1|Outcome|24-Month Supported Employment|Participants in Supported Employment.
882044|NCT01141647|E1|Reported Event|Baseline Sample (N=1047)|"Evidence-Based Supported Employment Vocational Rehabilitation or Other Vocational Services~Vocational Rehabilitation: SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services"
882045|NCT01141595|B1|Baseline|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
882046|NCT01141595|P1|Participant Flow|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
882047|NCT01141595|O1|Outcome|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
882048|NCT01141595|E1|Reported Event|Kuvan®|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
882049|NCT01141569|B1|Baseline|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882050|NCT01141569|P1|Participant Flow|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882051|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882052|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882089|NCT01141205|B1|Baseline|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
882053|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882054|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882055|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882056|NCT01141569|O1|Outcome|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882057|NCT01141569|E1|Reported Event|Treatment (RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Gamma-Secretase Inhibitor RO4929097: Given PO~Laboratory Biomarker Analysis: Correlative studies"
882058|NCT01141491|B3|Baseline|Total|Total of all reporting groups
882059|NCT01141491|B2|Baseline|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
882060|NCT01141491|B1|Baseline|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
882061|NCT01141491|P2|Participant Flow|Arm B - OPT-821 Immunologic Adjuvant|Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
882062|NCT01141491|P1|Participant Flow|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
882063|NCT01141491|O2|Outcome|Arm B - OPT-821 Immunologic Adjuvant|"Patients will be given 10 injections of OPT-821 alone as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84~OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84"
882064|NCT01141491|O1|Outcome|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
882065|NCT01141491|E2|Reported Event|Arm B - OPT-821 Immunologic Adjuvant|OPT-821: Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
882066|NCT01141491|E1|Reported Event|Arm A- Vaccine Plus OPT-821|Trivalent ganglioside vaccine: Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
882067|NCT01141374|B4|Baseline|Total|Total of all reporting groups
882068|NCT01141374|B3|Baseline|Control Group|untreated group
882069|NCT01141374|B2|Baseline|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
882070|NCT01141374|B1|Baseline|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
882071|NCT01141374|P3|Participant Flow|Control Group|untreated group
882072|NCT01141374|P2|Participant Flow|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
882073|NCT01141374|P1|Participant Flow|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
882074|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
882075|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 8 weeks (3rd evaluation) and follow-up (4th evaluation).
882076|NCT01141374|O1|Outcome|Control Group|Without intervention
882077|NCT01141374|O3|Outcome|Seeds Group|They received auriculotherapy by seeds at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
882078|NCT01141374|O2|Outcome|Needle Group|Subjects received needles at shenmen, kidney and brainstem points, 1 time per week, during 4 weeks (2nd evaluation).
882079|NCT01141374|O1|Outcome|Control Group|Without intervention
882080|NCT01141374|E3|Reported Event|Control Group|untreated group
882081|NCT01141374|E2|Reported Event|Auriculotherapy by Needles|Auriculotherapy with semi-permanent needles of 1.8mm, at shenmen, kidney and brainstem points 1 time per week for 8 weeks.
882082|NCT01141374|E1|Reported Event|Auriculotherapy by Seeds|Auriculotherapy Group by seeds at Shenmen,kidney and brainstem points,all of them for stress reduction. These points were used 1 time per week for 8 weeks. The subjects were instructed to carry out stimulation 3 times a day for at least 15 times.
882083|NCT01141283|B1|Baseline|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
882084|NCT01141283|P1|Participant Flow|Extension Phase (BTDS 5, 10, or 20)|Buprenorphine transdermal patches of BTDS 5, 10, or 20 applied for 7-day wear
883528|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
882090|NCT01141205|P2|Participant Flow|Saline|Placebo was Sterile saline injection, 1.25 ml i.m. (in m. deltoideus) at each vaccination weeks 0, 2, 4, 8
882091|NCT01141205|P1|Participant Flow|AFO-18|18 peptides representing 15 CD8 and 3 CD4 epitopes on HIV-1 plus 1 CD4 T helper epitope unrelated to HIV in an adjuvant (CAF01). Total 4.5 mg peptide (250 micro gram of each peptide) in CAF01 adjuvant. Total volume of 1.25 ml was injected i.m. (in m. deltoideus) at weeks 0, 2, 4, 8
882092|NCT01141205|O2|Outcome|Placebo|participants receiving saline
882093|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
882094|NCT01141205|O2|Outcome|Saline|Placebo participants receiving sterile saline i.m.
882095|NCT01141205|O1|Outcome|Vaccinee|participants receiving active HIV-1 peptide vaccine in CAF01 adjuvant i.m.
882096|NCT01141205|O2|Outcome|Placebo Saline|Saline injection
882097|NCT01141205|O1|Outcome|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
882098|NCT01141205|O2|Outcome|Placebo|participants receiving saline
882099|NCT01141205|O1|Outcome|Vaccinee|participants receiving active peptide in CAF01 adjuvants vaccine
882100|NCT01141205|E2|Reported Event|Saline|Saline injection
882101|NCT01141205|E1|Reported Event|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
882102|NCT01139879|B1|Baseline|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
882103|NCT01139879|P1|Participant Flow|P400|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
882104|NCT01139879|O1|Outcome|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
882105|NCT01139879|O1|Outcome|P400|The P400 mattress will be placed for a period of 12 weeks for all enrolled patients
882106|NCT01139879|O1|Outcome|P400 Support Surface|"All patients will receive the P400 mattress~P400 mattress: The P400 mattress will be placed for a period of 12 weeks."
882107|NCT01139879|E1|Reported Event|P400 Support Surface|All patients will receive the P400 mattress for a period of 12 weeks
882108|NCT01140906|B5|Baseline|Total|Total of all reporting groups
882109|NCT01140906|B4|Baseline|Duloxetine 60 mg|encapsulated capsules, daily, orally
882110|NCT01140906|B3|Baseline|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882111|NCT01140906|B2|Baseline|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882112|NCT01140906|B1|Baseline|Placebo|capsules, daily, orally
882113|NCT01140906|P4|Participant Flow|Duloxetine 60 mg|encapsulated capsules, daily, orally
882114|NCT01140906|P3|Participant Flow|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882115|NCT01140906|P2|Participant Flow|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882116|NCT01140906|P1|Participant Flow|Placebo|capsules, daily, orally
882117|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882118|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882119|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882120|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882121|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882122|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882123|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882124|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882125|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882126|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882127|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882128|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882129|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882130|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882131|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882132|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882133|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882134|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882135|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882136|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882137|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882138|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882139|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882140|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882141|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882142|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882143|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882144|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882145|NCT01140906|O4|Outcome|Duloxetine 60 mg|encapsulated capsules, daily, orally
882146|NCT01140906|O3|Outcome|Vortioxetine 20 mg|encapsulated tablets, daily, orally
882147|NCT01140906|O2|Outcome|Vortioxetine 15 mg|encapsulated tablets, daily, orally
882148|NCT01140906|O1|Outcome|Placebo|capsules, daily, orally
882149|NCT01140906|E4|Reported Event|Duloxetine 60 mg|
882150|NCT01140906|E3|Reported Event|Vortioxetine 20 mg|
882151|NCT01140906|E2|Reported Event|Vortioxetine 15 mg|
882152|NCT01140906|E1|Reported Event|Placebo|
882153|NCT01140880|B3|Baseline|Total|Total of all reporting groups
882169|NCT01140867|P1|Participant Flow|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
882170|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
882154|NCT01140880|B2|Baseline|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882155|NCT01140880|B1|Baseline|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882156|NCT01140880|P2|Participant Flow|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882157|NCT01140880|P1|Participant Flow|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882158|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882159|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882160|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882161|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882162|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882163|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882164|NCT01140880|O2|Outcome|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882165|NCT01140880|O1|Outcome|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882166|NCT01140880|E2|Reported Event|Yoked Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Incentives will be provided to participants independent of stimulant drug use and determined in the same rate and timing as a randomly selected participant in the active CM condition.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882167|NCT01140880|E1|Reported Event|Contingency Management|"Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for stimulant metabolites. Increasingly valuable incentives will be provided for urine samples that lack metabolites of stimulant drugs.~Truvada: Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada)."
882168|NCT01140867|B1|Baseline|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
882171|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
882172|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
882173|NCT01140867|O1|Outcome|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
882174|NCT01140867|E1|Reported Event|Zonisamide|Initial dose was 100mg/day, increased by 100mg in week 2 and 4. The target dose was 300mg/day, and the maximum dose was 400mg/day.
882175|NCT01140815|B3|Baseline|Total|Total of all reporting groups
882176|NCT01140815|B2|Baseline|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
882177|NCT01140815|B1|Baseline|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
882178|NCT01140815|P2|Participant Flow|Deuce|The Journey Deuce Bicompartmental Knee System
882179|NCT01140815|P1|Participant Flow|Total|The Smith and Nephew Total Knee System
882180|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
882181|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
882182|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
882183|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
882184|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
882185|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
882186|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
882187|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
882188|NCT01140815|O2|Outcome|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
882189|NCT01140815|O1|Outcome|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
882190|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882191|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882192|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882193|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882194|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882195|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882196|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882197|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882198|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882199|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882200|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882201|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882202|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882203|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882204|NCT01140815|O2|Outcome|Deuce|The Journey Deuce Bicompartmental Knee System
882205|NCT01140815|O1|Outcome|Total|The Smith and Nephew Total Knee System
882206|NCT01140815|E2|Reported Event|Deuce (Study)|"The Journey Deuce Bicompartmental Knee System~Deuce: Smith and Nephew Bicompartmental Knee Replacement"
882207|NCT01140815|E1|Reported Event|Total (Control)|"The Smith and Nephew Total Knee System~Total Knee Replacement: Smith and Nephew Total Knee Replacement"
882208|NCT01140646|B1|Baseline|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
882209|NCT01140646|P1|Participant Flow|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
882210|NCT01140646|O1|Outcome|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
882211|NCT01140646|E1|Reported Event|SAMe|The first week of the study is a baseline week where data are being collected but study agent is not being taken. Patients then receive oral s-adenosyl-L-methionine, 400 mg, once daily on days 8-14 and twice daily on days 15-49 in the absence of unacceptable toxicity.
882212|NCT01140503|B1|Baseline|Apremilast|All subjects received apremilast 20mg PO BID
882213|NCT01140503|P1|Participant Flow|Apremilast|All subjects received apremilast 20mg PO BID
882214|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
882215|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
882216|NCT01140503|O1|Outcome|Apremilast|All subjects received apremilast 20mg PO BID
882217|NCT01140503|E1|Reported Event|Apremilast|All subjects received apremilast 20mg PO BID
882218|NCT01140477|B3|Baseline|Total|Total of all reporting groups
882219|NCT01140477|B2|Baseline|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
882220|NCT01140477|B1|Baseline|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
882221|NCT01140477|P2|Participant Flow|Crystalens IOL|Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)
882222|NCT01140477|P1|Participant Flow|Crystalens Toric IOL|Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)
882223|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
882224|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
882225|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
882226|NCT01140477|O2|Outcome|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
882227|NCT01140477|O1|Outcome|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
882228|NCT01140477|E2|Reported Event|Crystalens IOL|"Crystalens silicone multi-piece accommodating IOL (Models AT-50SE/AT-52SE)~Accommodating Lens: Accommodating lens implanted during cataract extraction"
882229|NCT01140477|E1|Reported Event|Crystalens Toric IOL|"Crystalens toric silicone multi-piece accommodating IOL (Models AT-50T/AT-52T)~Toric Accommodating Lens: Toric accommodating lens implanted during cataract extraction"
882230|NCT01140347|B3|Baseline|Total|Total of all reporting groups
882231|NCT01140347|B2|Baseline|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882232|NCT01140347|B1|Baseline|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882233|NCT01140347|P2|Participant Flow|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882234|NCT01140347|P1|Participant Flow|Ramucirumab (IMC-1121B) + BSC|"Ramucirumab (IMC-1121B): 8 milligrams/kilogram (mg/kg) intravenous (IV) infusion every 2 weeks.~Best supportive care (BSC): Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator."
882235|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882236|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882237|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882238|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882239|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882240|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882241|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882242|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882243|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882244|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882245|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882246|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882247|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882248|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882249|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882368|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882250|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882251|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882252|NCT01140347|O2|Outcome|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882253|NCT01140347|O1|Outcome|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882254|NCT01140347|E2|Reported Event|Placebo + BSC|Placebo: 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882255|NCT01140347|E1|Reported Event|Ramucirumab (IMC-1121B) + BSC|Ramucirumab 8 mg/kg IV infusion every 2 weeks. BSC: Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
882256|NCT01140295|B3|Baseline|Total|Total of all reporting groups
882257|NCT01140295|B2|Baseline|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882258|NCT01140295|B1|Baseline|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882259|NCT01140295|P2|Participant Flow|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
882260|NCT01140295|P1|Participant Flow|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882261|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation~Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure."
882262|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation~Miralax (PEG-P) at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882263|NCT01140295|O2|Outcome|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882264|NCT01140295|O1|Outcome|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882265|NCT01140295|E2|Reported Event|2, Senna|"Senna colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882266|NCT01140295|E1|Reported Event|1, Miralax|"Miralax colonoscopy preparation~polyethylene glycol, senna : Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
882512|NCT01139164|B1|Baseline|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
882267|NCT01140191|B1|Baseline|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882268|NCT01140191|P1|Participant Flow|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882269|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882270|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882271|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882272|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882273|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882274|NCT01140191|O1|Outcome|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882275|NCT01140191|E1|Reported Event|WR 279,396|"All subjects in this one-arm study will receive topical WR 279,396~WR 279,396: Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days"
882276|NCT01140061|B11|Baseline|Total|Total of all reporting groups
882277|NCT01140061|B10|Baseline|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
882278|NCT01140061|B9|Baseline|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
882279|NCT01140061|B8|Baseline|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
882280|NCT01140061|B7|Baseline|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days
882281|NCT01140061|B6|Baseline|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
882282|NCT01140061|B5|Baseline|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
882283|NCT01140061|B4|Baseline|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
882284|NCT01140061|B3|Baseline|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
882285|NCT01140061|B2|Baseline|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days
882286|NCT01140061|B1|Baseline|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
882287|NCT01140061|P10|Participant Flow|Panel E and Extension - Placebo|In Part III, participants with mild psoriasis received skin application of placebo cream twice daily for up to 28 days.
882288|NCT01140061|P9|Participant Flow|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
882289|NCT01140061|P8|Participant Flow|Panel D - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
882290|NCT01140061|P7|Participant Flow|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
882291|NCT01140061|P6|Participant Flow|Panel C - Placebo|In Part II, healthy participants received skin application of placebo cream once daily for 10 days.
882292|NCT01140061|P5|Participant Flow|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
882293|NCT01140061|P4|Participant Flow|Panel B - Placebo|In Part II, healthy participants received skin application of placebo cream twice daily for 10 days.
882294|NCT01140061|P3|Participant Flow|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
882295|NCT01140061|P2|Participant Flow|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
882296|NCT01140061|P1|Participant Flow|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
882297|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
882298|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
882299|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
882300|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
882301|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
882302|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
882303|NCT01140061|O6|Outcome|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
882304|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
882305|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
882306|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
882307|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
882308|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
882309|NCT01140061|O5|Outcome|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
882310|NCT01140061|O4|Outcome|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
882311|NCT01140061|O3|Outcome|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
882312|NCT01140061|O2|Outcome|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
882313|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
882314|NCT01140061|O2|Outcome|Panel A - Placebo|In Part I, healthy participants received skin patches containing nothing (plain patch) and placebo once daily for 21 days.
882315|NCT01140061|O1|Outcome|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
882316|NCT01140061|E6|Reported Event|Placebo - Pooled|In Parts I, II, and III, participants who received skin application of cream or patches containing placebo (and no patches containing MK-0873) were pooled for analysis.
882317|NCT01140061|E5|Reported Event|Panel E and Extension - MK-0873 200 mg|In Part III, participants with mild psoriasis received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) twice daily for up to 28 days.
882318|NCT01140061|E4|Reported Event|Panel D - MK-0873 200 mg|In Part II, healthy participants received skin application of 2% MK-0873 (yielding a dose of 100 mg of MK-0873) twice daily for 10 days.
882319|NCT01140061|E3|Reported Event|Panel C - MK-0873 100 mg|In Part II, healthy participants received skin application of 2% MK-0873 cream (yielding a dose of 100 mg of MK-0873) once daily for 10 days.
882320|NCT01140061|E2|Reported Event|Panel B - MK-0873 25 mg|In Part II, healthy participants received skin application of 0.5% MK-0873 cream (yielding a dose of 25 mg of MK-0873) twice daily for 10 days.
882321|NCT01140061|E1|Reported Event|Panel A - MK-0873 5.1 mg|In Part I, healthy participants received skin patches containing nothing (plain patches), placebo, and various potencies of MK-0873 cream (0.05%, 0.5%, or 2%; yielding a dose of 5.1 mg MK-0873) once daily for 21 days.
882322|NCT01140048|B1|Baseline|All Enrolled Participants|
882323|NCT01140048|P1|Participant Flow|All Enrolled Participants|
882324|NCT01140048|O1|Outcome|All Enrolled Participants|
882325|NCT01140048|O1|Outcome|All Enrolled Participants|
882326|NCT01140048|O1|Outcome|All Enrolled Participants|
882327|NCT01140048|E1|Reported Event|All Enrolled Participants|
882328|NCT01139996|B3|Baseline|Total|Total of all reporting groups
882329|NCT01139996|B2|Baseline|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
882330|NCT01139996|B1|Baseline|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
882331|NCT01139996|P2|Participant Flow|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
882332|NCT01139996|P1|Participant Flow|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
882333|NCT01139996|O2|Outcome|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
882369|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882370|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882334|NCT01139996|O1|Outcome|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
882335|NCT01139996|E2|Reported Event|Comparator|"Placebo group will receive a placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final placebo tablet~Placebo: A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet"
882336|NCT01139996|E1|Reported Event|Transdermal Clonidine/Oral Clonidine|"An oral loading dose of Clonidine 0.3 mg and placement of a Clonidine Transdermal system at a dose of 0.3 mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3 mg after 12 hours~Clonidine: An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours"
882337|NCT01139814|B1|Baseline|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
882338|NCT01139814|P1|Participant Flow|Intent-to-Treat|"Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.~Amigo RCS is an accessory for use in the cardiac EP setting to allow the operator to manipulate a steerable cardiac catheter and perform a conventional electrophysiology procedure. The intent of the device is to allow the operator to complete the procedure in a conventional x-ray guided EP lab. Catheter control can be performed while standing (or sitting) some distance from the subject to minimize absorbed radiology dose and minimize operator fatigue from standing for long periods of time with the standard lead aprons/personal protection devices."
882339|NCT01139814|O1|Outcome|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
882340|NCT01139814|O1|Outcome|Intent-to-Treat|A subject was considered Intent-to-treat once the subject was evaluated for the study criteria on the day of procedure, the Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
882341|NCT01139814|E1|Reported Event|Intent-to-Treat|Subject was evaluated for the study criteria on the day of procedure, Investigator positioned the mapping catheter in the right heart, and connected the mapping catheter to the Amigo RCS.
882342|NCT01139762|B3|Baseline|Total|Total of all reporting groups
882343|NCT01139762|B2|Baseline|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882344|NCT01139762|B1|Baseline|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882345|NCT01139762|P3|Participant Flow|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
882346|NCT01139762|P2|Participant Flow|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
882347|NCT01139762|P1|Participant Flow|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
882348|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882349|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882350|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882351|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882352|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882353|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882354|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882355|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882356|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882357|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882358|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882359|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882360|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882361|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882362|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882363|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882364|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882365|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882366|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882367|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882479|NCT01139411|B3|Baseline|Total|Total of all reporting groups
882371|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882372|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882373|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882374|NCT01139762|O2|Outcome|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882375|NCT01139762|O1|Outcome|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks.
882376|NCT01139762|E3|Reported Event|Placebo|Placebo orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
882377|NCT01139762|E2|Reported Event|Tadalafil|5 milligrams (mg) Tadalafil orally, once daily co-administered with 5 mg Finasteride orally, once daily for 26 weeks during double-blind randomized active treatment period.
882378|NCT01139762|E1|Reported Event|Screening-Washout and Placebo Lead-In|4 weeks washout period and followed by placebo orally, once daily for 4 weeks during placebo lead-in period.
882379|NCT01139658|B3|Baseline|Total|Total of all reporting groups
882380|NCT01139658|B2|Baseline|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882381|NCT01139658|B1|Baseline|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882382|NCT01139658|P2|Participant Flow|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882383|NCT01139658|P1|Participant Flow|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882384|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882385|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882386|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882387|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882388|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882389|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882390|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882391|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882392|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882393|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882394|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882395|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882396|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882397|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882398|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882399|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882400|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882401|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882402|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882403|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882513|NCT01139164|P3|Participant Flow|Group 3: Regimen C|B-Cell Lymphomas
882404|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882405|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882406|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882407|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882408|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882409|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882410|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882411|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882412|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882413|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882414|NCT01139658|O2|Outcome|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882415|NCT01139658|O1|Outcome|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882416|NCT01139658|E2|Reported Event|Total Hip Replacement|Patients undergoing elective total hip replacement (THR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882417|NCT01139658|E1|Reported Event|Total Knee Replacement|Patients undergoing elective total knee replacement (TKR) received a dose of dabigatran etexilate; the administered treatment was based on usual practice in a real-life setting.
882418|NCT01139580|B3|Baseline|Total|Total of all reporting groups
882419|NCT01139580|B2|Baseline|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882420|NCT01139580|B1|Baseline|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882421|NCT01139580|P2|Participant Flow|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882422|NCT01139580|P1|Participant Flow|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body twice daily (BD) for 8 weeks.
882423|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882424|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882425|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882426|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882427|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882428|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882429|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882430|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882431|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882432|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882433|NCT01139580|O2|Outcome|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882434|NCT01139580|O1|Outcome|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882435|NCT01139580|E2|Reported Event|Vehicle Foam|Vehicle foam was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882436|NCT01139580|E1|Reported Event|Calcipotriene Foam|Calcipotriene foam 0.005% was applied to the affected area(s) on the scalp and body BD for 8 weeks.
882437|NCT01139515|B1|Baseline|Entire Study Population|All participants randomized to any treatment (Eletriptan 20 mg tablet first, eletriptan 40 mg tablet first, eletriptan 80 mg tablet first, and eletriptan 40 mg 2 hrs apart repeated dose (80 mg in total).
882438|NCT01139515|P4|Participant Flow|Eletriptan 40 mg 2 Hrs Apart Repeated Dose,20 mg,80 mg,40 mg|Two oral doses of 40 mg eletriptan tablet administered 2 hrs apart tablet in first intervention period; followed by single oral dose of eletriptan 20 mg in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and single oral dose of eletriptan 40 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
882480|NCT01139411|B2|Baseline|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882615|NCT01138969|O2|Outcome|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
882439|NCT01139515|P3|Participant Flow|Eletriptan 80 mg,40 mg 2 Hrs Apart Repeated Dose,40 mg,20 mg|Single oral dose of eletriptan 80 mg tablet in first intervention period; followed by two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in second intervention period; then single oral dose of eletriptan 40 mg tablet in third intervention period; and single oral dose of eletriptan 20 mg tablet in fourth intervention period. A washout period of 46 hrs was maintained between each period.
882440|NCT01139515|P2|Participant Flow|Eletriptan 40 mg,80 mg,20 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 40 mg tablet in first intervention period; followed by single oral dose of eletriptan 80 mg tablet in second intervention period; then single oral dose of eletriptan 20 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
882441|NCT01139515|P1|Participant Flow|Eletriptan 20 mg,40 mg,80 mg,40 mg 2 Hrs Apart Repeated Dose|Single oral dose of eletriptan 20 mg tablet in first intervention period; followed by single oral dose of eletriptan 40 mg tablet in second intervention period; then single oral dose of eletriptan 80 mg tablet in third intervention period; and two oral doses of 40 mg eletriptan tablet administered 2 hrs apart in fourth intervention period. A washout period of 46 hrs was maintained between each period.
882442|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
882443|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
882444|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
882445|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
882446|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
882447|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
882448|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
882449|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
882450|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
882451|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
882452|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
882453|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
882454|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
882455|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
882456|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
882457|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
882458|NCT01139515|O4|Outcome|Eletriptan 40 mg Tablet 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
882459|NCT01139515|O3|Outcome|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
882460|NCT01139515|O2|Outcome|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
882461|NCT01139515|O1|Outcome|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
882462|NCT01139515|E4|Reported Event|Eletriptan 40 mg 2 Hrs Apart Repeated Dose|Repeated oral dose of eletriptan 40 mg tablet administered 2 hrs apart (total dose = 80 mg). (Treatment D).
882463|NCT01139515|E3|Reported Event|Eletriptan 80 mg Tablet|Single oral dose of two eletriptan 40 mg tablets (Treatment C).
882464|NCT01139515|E2|Reported Event|Eletriptan 40 mg Tablet|Single oral dose of eletriptan 40 mg tablet (Treatment B).
882465|NCT01139515|E1|Reported Event|Eletriptan 20 mg Tablet|Single oral dose of eletriptan 20 mg tablet (Treatment A).
882466|NCT01139450|B4|Baseline|Total|Total of all reporting groups
882467|NCT01139450|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
882468|NCT01139450|B2|Baseline|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
882469|NCT01139450|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
882470|NCT01139450|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
882471|NCT01139450|P2|Participant Flow|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
882472|NCT01139450|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
882473|NCT01139450|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
882474|NCT01139450|O2|Outcome|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
882475|NCT01139450|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
882476|NCT01139450|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.03% applied twice daily for 4 weeks"
882477|NCT01139450|E2|Reported Event|Reference|"Reference product that contains the active pharmaceutical ingredient~Protopic Ointment 0.03%, Reference product applied twice daily for 4 weeks"
882478|NCT01139450|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.03% test product applied twice daily for 4 weeks"
882481|NCT01139411|B1|Baseline|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882482|NCT01139411|P2|Participant Flow|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882483|NCT01139411|P1|Participant Flow|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882484|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882485|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882486|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882487|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882488|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882489|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882490|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882491|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882492|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882493|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882494|NCT01139411|O2|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882495|NCT01139411|O1|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882496|NCT01139411|O2|Outcome|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882497|NCT01139411|O1|Outcome|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882498|NCT01139411|E2|Reported Event|Behavioral Weight Control With Enhanced Parent Involvement|"This treatment arm included periodic dyadic sessions with adolescents and their parents, focusing on weight-related communication combined with standard behavioral weight control.~Behavioral Weight Control with Enhanced Parent Involvement"
882499|NCT01139411|E1|Reported Event|Behavioral Weight Control With Minimal Parent Involvement|"This treatment arm included standard behavioral weight control delivered to the adolescent with minimal parent involvement.~Behavioral Weight Control with Minimal Parent Involvement"
882500|NCT01139190|B3|Baseline|Total|Total of all reporting groups
882501|NCT01139190|B2|Baseline|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
882502|NCT01139190|B1|Baseline|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
882503|NCT01139190|P2|Participant Flow|Naproxen|Subjects were to take 500 mg of Naproxen (two 250 mg tablets) of study drug twice a day for a total duration of 14.5 days.
882504|NCT01139190|P1|Participant Flow|PL3100|Subjects were to take 500 mg of PL3100 (two 250 mg capsules) of study drug twice a day for a total duration of 14.5 days.
882505|NCT01139190|O2|Outcome|Naproxen|Naproxen: Oral administration
882506|NCT01139190|O1|Outcome|PL3100|PL3100: Oral administration
882507|NCT01139190|E2|Reported Event|Naproxen|Naproxen: Oral administration
882508|NCT01139190|E1|Reported Event|PL3100|PL3100: Oral administration
882509|NCT01139164|B4|Baseline|Total|Total of all reporting groups
882510|NCT01139164|B3|Baseline|Group 3: Regimen C|B-Cell Lymphomas
882511|NCT01139164|B2|Baseline|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
884012|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
882514|NCT01139164|P2|Participant Flow|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
882515|NCT01139164|P1|Participant Flow|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
882516|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
882517|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
882518|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
882519|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
882520|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
882521|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
882522|NCT01139164|O3|Outcome|Group 3: Regimen C|B-Cell Lymphomas
882523|NCT01139164|O2|Outcome|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
882524|NCT01139164|O1|Outcome|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
882525|NCT01139164|E3|Reported Event|Group 3: Regimen C|B-Cell Lymphomas
882526|NCT01139164|E2|Reported Event|Group 2: Regimen B|Other Malignancies not addressed in regimens A and C
882527|NCT01139164|E1|Reported Event|Group 1: Regimen A|Regimen A: Chronic Lymphocytic Leukemia/Chronic Prolymphocytic Leukemia/Multiple Myeloma
882528|NCT01139125|B1|Baseline|Cystagon|One black male and two white males started the study
882529|NCT01139125|P1|Participant Flow|Cystagon (Cysteamine Bitartrate)|Subjects were expected to take cystagon (cysteamine bitarate)14 capsules per day (4 at 7:00 am, 3 at 12:00 pm, 4 at 5:00 pm and 3 at 10:00pm) for 16 weeks.
882530|NCT01139125|O1|Outcome|Cystagon|Subjects are required to take 14 capsules per day for 16 weeks
882531|NCT01139125|E1|Reported Event|Cystagon|Subjects taking 14 capsules per day for 16 weeks
882532|NCT01139047|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
882533|NCT01139047|P1|Participant Flow|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where MetroGel®(metronidazole gel) 1% was applied topically to one side of the face once daily for 3 weeks and Finacea® (azelaic acid) gel 15% was applied to the opposite side of the face twice daily for 3 weeks
882534|NCT01139047|O1|Outcome|MetroGel® 1% and Finacea Gel® 15%|This was a randomized split-face study where metronidazole 1% gel was applied to one side of the face once daily for 3 weeks and azelaic acid 15 % gel was applied to the opposite side of the face twice daily for 3 weeks
882535|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
882536|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
882537|NCT01139047|O2|Outcome|Finacea Gel® 15%|azelaic acid 15 % gel - apply topically to the opposite side of the face twice daily for 3 weeks
882538|NCT01139047|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
882539|NCT01139047|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically to the opposite side of the face twice daily for 3 weeks
882540|NCT01139047|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
882541|NCT01139021|B7|Baseline|Total|Total of all reporting groups
882542|NCT01139021|B6|Baseline|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
882543|NCT01139021|B5|Baseline|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882544|NCT01139021|B4|Baseline|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
882545|NCT01139021|B3|Baseline|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
882546|NCT01139021|B2|Baseline|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
882547|NCT01139021|B1|Baseline|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
882548|NCT01139021|P6|Participant Flow|B12M13|Subject was randomized in group B13_15_27 but treated as group B12_M13.
882549|NCT01139021|P5|Participant Flow|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882550|NCT01139021|P4|Participant Flow|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
882551|NCT01139021|P3|Participant Flow|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
882552|NCT01139021|P2|Participant Flow|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
882553|NCT01139021|P1|Participant Flow|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
882554|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882555|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882616|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
882556|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
882557|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
882558|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 12 and 14 months of age.
882559|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
882560|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882561|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882562|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882563|NCT01139021|O1|Outcome|B_24_26|Subjects assessed at 1 month and 6 months post two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882564|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
882565|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
882566|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
882567|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
882568|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
882569|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
882570|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
882571|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
882572|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
882573|NCT01139021|O3|Outcome|B12+B13Tot|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 13th and 15th months or 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27th or 26th months of age.
882574|NCT01139021|O2|Outcome|B12_14_26|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at either 12th and 14th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 26 months of age.
882575|NCT01139021|O1|Outcome|B13_15_27|Subjects assessed at 12 months after two catch-up doses of rMenB+OMV NZ administered to children at 13th and 15th months of age and MMRV at 12th month; at 1 month and 6 months post booster dose administered at 27 months of age.
882576|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
882577|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
882578|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
882579|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
882580|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age
882581|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
882582|NCT01139021|O3|Outcome|B246_12Tot|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 12th or 13th month after primary vaccination at 2nd ,4th and 6th months of age
882583|NCT01139021|O2|Outcome|B246_12M13|Subjects assessed one year post administration of rMenB+OMV NZ at 12th month and MMRV at 13th month after primary vaccination at 2nd ,4th and 6th months of age.
882584|NCT01139021|O1|Outcome|B246_12M12|Subjects assessed one year post administration of rMenB+OMV NZ and MMRV at 12th month after primary vaccination at 2nd ,4th and 6th months of age.
882585|NCT01139021|E3|Reported Event|B24_26|Subjects assessed for safety and tolerability after two catch-up doses of rMenB+OMV NZ administered to naive children at 24 and 26 months of age.
882586|NCT01139021|E2|Reported Event|B12_14_26|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at either 12 and 14 months of age.
882587|NCT01139021|E1|Reported Event|B13_15_27|Subjects assessed for safety and tolerability after receiving a booster (third) dose of rMenB+OMV NZ at one year after two catch-up doses of rMenB+OMV NZ, previously administered to children at 13 and 15 months of age.
882588|NCT01139008|B1|Baseline|MetroGel® 1% and Finacea® Gel 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
882589|NCT01139008|P1|Participant Flow|MetroGel® 1% and Finacea 15%|This was a randomized split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid gel 15% was applied to the opposite side of the face twice daily for 3 weeks
882590|NCT01139008|O1|Outcome|MetroGel® 1% and Finacea® Gel 15%|This is a split-face study where metronidazole gel 1% was applied topically to one side of the face once daily for 3 weeks and azelaic acid 15% gel was applied topically to the opposite side of the face twice daily for 3 weeks
882591|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
882592|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
882593|NCT01139008|O2|Outcome|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
882594|NCT01139008|O1|Outcome|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
882595|NCT01139008|E2|Reported Event|Finacea® Gel 15%|azelaic acid gel 15% - apply topically twice daily to the opposite side of the face
882596|NCT01139008|E1|Reported Event|MetroGel® 1%|metronidazole gel 1% - apply topically to one side of the face once daily for 3 weeks
882597|NCT01138995|B3|Baseline|Total|Total of all reporting groups
882598|NCT01138995|B2|Baseline|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
882599|NCT01138995|B1|Baseline|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
882600|NCT01138995|P2|Participant Flow|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 42 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
882601|NCT01138995|P1|Participant Flow|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks. After 30 weeks, the Original Control Group will then be crossed over to walk with the Ness L300 for a total of 12 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.~Ness L300: The Original Treatment Group will walk with the Ness L300 for 42 weeks, and the Original Control Group will walk with a usual ankle-foot orthosis (AFO)for 30 weeks, then be crossed over to walk with the Ness L300 for a total of 12 weeks."
882602|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
882603|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
882604|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~Ness L300: The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
882605|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
882606|NCT01138995|O2|Outcome|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
882607|NCT01138995|O1|Outcome|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO)for 30 weeks."
882608|NCT01138995|E2|Reported Event|Original Treatment Group|"The Original Treatment Group will walk with the Ness L300 for 30 weeks.~The Ness L300 delivers functional electrical stimulation (FES), is intended to improve gait function, stroke-specific quality of life, functionality, and safety for persons with stroke."
882609|NCT01138995|E1|Reported Event|Originial Control Group|"The Control Group will walk with the a usual ankle-foot orthosis (AFO) for 30 weeks."
882610|NCT01138969|B3|Baseline|Total|Total of all reporting groups
882611|NCT01138969|B2|Baseline|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
882612|NCT01138969|B1|Baseline|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
882613|NCT01138969|P2|Participant Flow|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
882614|NCT01138969|P1|Participant Flow|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
892166|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
882618|NCT01138969|O1|Outcome|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
882619|NCT01138969|E2|Reported Event|Clopidogrel Group|clopidogrel 75 mg qd for 6 months
882620|NCT01138969|E1|Reported Event|Esomeprazole Plus Clopidogrel Group|esomeprazole (20 mg qd) plus clopidogrel (75 mg qd) for 6 months
882621|NCT01138826|B1|Baseline|Entire Study Population|All participants randomized to any treatment.(Amlodipine tablet first, amlodipine ODT first, and amlodipine ODT without water first).
882622|NCT01138826|P6|Participant Flow|Amlodipine ODT Without Water,Amlodipine ODT,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg ODT in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
882623|NCT01138826|P5|Participant Flow|Amlodipine ODT Without Water,Amlodipine Tablet,Amlodipine ODT|Single oral dose amlodipine 10 mg ODT without water in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
882624|NCT01138826|P4|Participant Flow|Amlodipine ODT,Amlodipine Tablet,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg tablet in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
882625|NCT01138826|P3|Participant Flow|Amlodipine ODT,Amlodipine ODT Without Water,Amlodipine Tablet|Single oral dose amlodipine 10 mg ODT in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg tablet in third intervention period. A washout period of 16 days was maintained between each period.
882626|NCT01138826|P2|Participant Flow|Amlodipine Tablet,Amlodipine ODT Without Water,Amlodipine ODT|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg ODT without water in second intervention period; and single oral dose of amlodipine 10 mg ODT in third intervention period. A washout period of 16 days was maintained between each period.
882627|NCT01138826|P1|Participant Flow|Amlodipine Tablet,Amlodipine ODT,Amlodipine ODT Without Water|Single oral dose amlodipine 10 mg tablet in first intervention period; followed by single oral dose of amlodipine 10 mg oral disintegrating tablet (ODT) in second intervention period; and single oral dose of amlodipine 10 mg ODT without water in third intervention period. A washout period of 16 days was maintained between each period.
882628|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882629|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882630|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882631|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882632|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882633|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882634|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882635|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
884013|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
882636|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882637|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882638|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882639|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882640|NCT01138826|O3|Outcome|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882641|NCT01138826|O2|Outcome|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882642|NCT01138826|O1|Outcome|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882643|NCT01138826|E3|Reported Event|Amlodipine 10 mg ODT Without Water (Test Product C)|Test product C without water on Day 1 in first intervention period, followed by treatment with either Reference product A or Test product B on Day 1 of second and third intervention period, respectively Participants received all treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882644|NCT01138826|E2|Reported Event|Amlodipine 10 mg ODT With Water (Test Product B)|Test product B (single oral dose of amlodipine 10 mg ODT with 240 ml water) on Day 1 in first intervention period, followed by treatment with either Reference product A (single oral dose of amlodipine 10 mg tablet with 240 ml water) or Test product C (single oral dose of amlodipine 10 mg ODT without water) on Day 1 of second and third intervention period, respectively. Participants received treatment in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882645|NCT01138826|E1|Reported Event|Amlodipine 10mg Tablet With Water (Reference Product A)|Treatment A (single oral dose of amlodipine 10 mg tablet with 240 ml water [Reference product A]) on Day 1 in first intervention period. Treatment B (single oral dose of amlodipine 10 mg ODT with 240 ml water [Test product B]) on Day 1 of second intervention period. Treatment C (single oral dose of amlodipine 10 mg ODT without water [Test product C]) on Day 1 of third intervention period. Participants received all treatments in the morning under fasted conditions in all the 3 periods. A washout period of 16 days was maintained between each period.
882646|NCT01138735|B3|Baseline|Total|Total of all reporting groups
882647|NCT01138735|B2|Baseline|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
882648|NCT01138735|B1|Baseline|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
882649|NCT01138735|P2|Participant Flow|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
882650|NCT01138735|P1|Participant Flow|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
882651|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
882652|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
882653|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
882654|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
882655|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
882656|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
882657|NCT01138735|O2|Outcome|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
882658|NCT01138735|O1|Outcome|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
882659|NCT01138735|E2|Reported Event|Topical Gel Vehicle|Topical Gel Vehicle applied topically once daily for 12 weeks
882660|NCT01138735|E1|Reported Event|Adapalene/Benzoyl Peroxide|Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks
882661|NCT01138657|B3|Baseline|Total|Total of all reporting groups
882662|NCT01138657|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882663|NCT01138657|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882664|NCT01138657|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882665|NCT01138657|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882666|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882667|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882668|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882669|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882670|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882671|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882672|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882673|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882674|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882675|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882676|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882677|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882722|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
882723|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
882724|NCT01138514|E3|Reported Event|Vehicle|Placebo: Placebo
882678|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882679|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882680|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882681|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882682|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882683|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882684|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882685|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882686|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882687|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882688|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882689|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882690|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882691|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882692|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882693|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882694|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882695|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882696|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882697|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882698|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882699|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882700|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882701|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882702|NCT01138657|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882703|NCT01138657|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882704|NCT01138657|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses every other week (eow) starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882705|NCT01138657|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882706|NCT01138657|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882707|NCT01138657|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper until Week 15.
882708|NCT01138514|B4|Baseline|Total|Total of all reporting groups
882709|NCT01138514|B3|Baseline|Vehicle|Placebo: Placebo
882710|NCT01138514|B2|Baseline|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
882711|NCT01138514|B1|Baseline|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
882712|NCT01138514|P3|Participant Flow|Vehicle|Placebo: Placebo
882713|NCT01138514|P2|Participant Flow|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
882714|NCT01138514|P1|Participant Flow|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
882715|NCT01138514|O3|Outcome|Vehicle|Placebo
882716|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
882717|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
882718|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
882719|NCT01138514|O2|Outcome|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
882720|NCT01138514|O1|Outcome|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
882721|NCT01138514|O3|Outcome|Vehicle|Placebo: Placebo
883163|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
882725|NCT01138514|E2|Reported Event|Reference Product|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin): Applied to the entire face twice daily for 10 weeks
882726|NCT01138514|E1|Reported Event|Clindamycin 1%/Benzoyl Peroxide 5%|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo): Applied to the entire face twice daily for 10 weeks
882727|NCT01138501|B1|Baseline|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
882728|NCT01138501|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
882729|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
882730|NCT01138501|O1|Outcome|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
882731|NCT01138501|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|The patients received bleeding preventive treatment with a single dose of turoctocog alfa of 25-50 IU/kg every second day or 25-60 IU/kg three times weekly. Turoctocog alfa was administered as a slow bolus i.v. injection (approximately 1-2 mL/min). Pharmacokinetic assessments were performed in at least 13 patients from each age cohort. Each patient participating in the pharmacokinetic assessments received one dose of previous factor VIII (FVIII) and one dose of turoctocog alfa.
882732|NCT01138475|B4|Baseline|Total|Total of all reporting groups
882733|NCT01138475|B3|Baseline|Placebo|
882734|NCT01138475|B2|Baseline|Cholecalciferol|
882735|NCT01138475|B1|Baseline|Paricalcitol|
882736|NCT01138475|P3|Participant Flow|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882737|NCT01138475|P2|Participant Flow|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882738|NCT01138475|P1|Participant Flow|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882739|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882740|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882741|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882774|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882742|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882743|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882744|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882745|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882746|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882747|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882748|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882749|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882750|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882751|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882752|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882753|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882754|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882755|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882756|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882757|NCT01138475|O3|Outcome|Placebo-controlled|"The placebo group received a placebo capsule, 1 daily each day of the week. This was a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).~Consenting adult participants were randomized in a 1:1:1 ratio to each treatment group and received paricalcitol capsules, cholecalciferol capsules, or placebo. Per inclusion criteria, all had previously undergone GB for the treatment of morbid obesity, were between 6 weeks and 5 years post-surgery with secondary hyperparathyroidism, defined as a serum PTH level greater than 69 pg/mL."
882758|NCT01138475|O2|Outcome|Cholecalciferol|"The cholecalciferol arm was treated with 5000 IU of cholecalciferol total of 35,000 IUper week.~This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively)."
882759|NCT01138475|O1|Outcome|Paricalcitrol|Paricalcitriol arm received1 mcg daily each day of the week. This study was randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and placebo on serum PTH levels after a 6-week trial in patients with secondary hyperparathyroidism after GB surgery. We enrolled 49 subjects (16, 17, and 16 in the paricalcitriol, cholecalciferol, and placebo groups, respectively).
882760|NCT01138475|O3|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Placebo: Inactive substance, one capsule daily for 6 weeks"
882761|NCT01138475|O2|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
882762|NCT01138475|O1|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program will be sufficient to enroll approximately 75 subjects (25 per treatment group).~Paricalcitol: 1 microgram by mouth daily for 6 weeks"
882763|NCT01138475|O3|Outcome|Placebo|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Placebo: Inactive substance, one capsule daily for 6 weeks"
882764|NCT01138475|O2|Outcome|Cholecalciferol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules, cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Cholecalciferol: 5000 IU (international units) by mouth daily for 6 weeks"
882765|NCT01138475|O1|Outcome|Paricalcitol|"This is a randomized, double-blind, double-dummy, placebo-controlled trial investigating the effects of paricalcitol capsules,cholecalciferol capsules, and matching placebo on PTH level at 6 weeks in patients with sHPT after RYGB. The pool of patients in the Beaumont Bariatric Surgery program~Paricalcitol: 1 microgram by mouth daily for 6 weeks"
882766|NCT01138475|E3|Reported Event|Placebo|Placebo capsules, one a day 7 days per week
882767|NCT01138475|E2|Reported Event|Cholecalciferol|cholecalciferol 5000 units per day, 7 days per week
882768|NCT01138475|E1|Reported Event|Paricalcitriol|Paricalcitriol 1 mcg per day 7 days per week
882769|NCT01138150|B3|Baseline|Total|Total of all reporting groups
882770|NCT01138150|B2|Baseline|Sugar Pill|Participants randomized to placebo (sugar pill) during acute migraine attack.
882771|NCT01138150|B1|Baseline|Treximet|Participants randomized to active drug Treximet during acute migraine attack.
882772|NCT01138150|P2|Participant Flow|Placebo|Participants randomized to placebo upon presentation with acute migraine attack.
882773|NCT01138150|P1|Participant Flow|Active Drug - Sumatriptan/Naproxen|Participants randomized to sumatriptan/naproxen upon presentation of migraine acute attack
883164|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
882775|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882776|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882777|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882778|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882779|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882780|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882781|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882782|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882783|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882784|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882785|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882786|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882787|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882788|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882789|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882790|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882791|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882792|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882793|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882794|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882795|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882796|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882797|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882798|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882799|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882800|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882801|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882802|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882803|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882804|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882805|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882806|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882807|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882808|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882809|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882810|NCT01138150|O6|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882811|NCT01138150|O5|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882812|NCT01138150|O4|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882813|NCT01138150|O3|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882814|NCT01138150|O2|Outcome|Treatment Non Responders 120 Minutes After Treatment|Participants without reduction in pain at 120 minutes after treatment
882815|NCT01138150|O1|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders were defined as those with a reduction of pain from moderate to severe (>=4/10 on the NRS) at T0 to no to mild (<=3/10 on the NRS) at 120 minutes after treatment with either sumatriptan/naproxen or placebo
882816|NCT01138150|O6|Outcome|Treatment Non-Responders|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
882817|NCT01138150|O5|Outcome|Treatment Responders 120 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 120 minutes after treatment with Treximet or sugar pill.
882818|NCT01138150|O4|Outcome|Treatment Non-Responders 60 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
882819|NCT01138150|O3|Outcome|Treatment Responders 60 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 60 minutes after treatment with Treximet or sugar pill.
882820|NCT01138150|O2|Outcome|Treatment Non-Responders 30 Minutes After Treatment|Treatment non-responders are defined as those without a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after after treatment with Treximet or sugar pill.
882821|NCT01138150|O1|Outcome|Treatment Responders 30 Minutes After Treatment|Treatment responders are defined as those with a reduction of pain from moderate to severe at T0 (before treatment) to none to mild 30 minutes after treatment with Treximet or sugar pill.
882822|NCT01138150|E2|Reported Event|Sugar Pill|Placebo: One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
882823|NCT01138150|E1|Reported Event|Treximet|sumatriptan/naproxen sodium: One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
882824|NCT01138124|B5|Baseline|Total|Total of all reporting groups
882825|NCT01138124|B4|Baseline|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
882826|NCT01138124|B3|Baseline|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
882827|NCT01138124|B2|Baseline|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
882828|NCT01138124|B1|Baseline|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
882829|NCT01138124|P4|Participant Flow|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
882869|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Results from 12 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
882870|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Results from 12 month scan for participants with no progression to AD within 2 years after baseline scan.
892167|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
882830|NCT01138124|P3|Participant Flow|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
882831|NCT01138124|P2|Participant Flow|Pancreatic Cancer Controls|"Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site.~The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin."
882832|NCT01138124|P1|Participant Flow|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
882833|NCT01138124|O2|Outcome|Controls|Controls
882834|NCT01138124|O1|Outcome|Cases|Cases
882835|NCT01138124|O2|Outcome|Controls|Controls
882836|NCT01138124|O1|Outcome|Cases|Cases
882837|NCT01138124|O2|Outcome|Controls|Controls
882838|NCT01138124|O1|Outcome|Cases|Cases
882839|NCT01138124|O2|Outcome|Controls|Controls
882840|NCT01138124|O1|Outcome|Cases|Cases
882841|NCT01138124|O2|Outcome|Controls|Controls
882842|NCT01138124|O1|Outcome|Cases|Cases
882843|NCT01138124|O2|Outcome|Controls|Controls
882844|NCT01138124|O1|Outcome|Cases|Cases
882845|NCT01138124|O2|Outcome|Controls|Controls
882846|NCT01138124|O1|Outcome|Cases|Cases
882847|NCT01138124|O2|Outcome|Controls|Controls
882848|NCT01138124|O1|Outcome|Cases|Cases
882849|NCT01138124|E4|Reported Event|Renal Cancer Controls|Renal cancer cases were risk set matched with up to 10 controls for sex, age at cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
882850|NCT01138124|E3|Reported Event|Renal Cancer Cases|Incident renal cancer, defined as first time renal cancer diagnosis (READ/OXMIS codes) in the GPRD study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident renal cancer diagnosis. Renal cell carcinoma and renal pelvis cancer were included; Wilm’s tumor and cancer metastatic to kidney were excluded.
882851|NCT01138124|E2|Reported Event|Pancreatic Cancer Controls|Pancreatic cancer cases were risk set matched with up to 10 controls for sex, age at GPRD study cohort entry (within two years), calendar year of cohort entry (within one year), and General Practice site. The index date for controls was set as the date at which the follow-up time from cohort entry was the same as the case. The index date was chosen so as to give the control equal follow-up time to that of the case for ascertainment of use of gabapentin.
882852|NCT01138124|E1|Reported Event|Pancreatic Cancer Cases|Incident pancreatic cancer, defined as first time pancreatic cancer diagnosis (READ/ Oxford Medical Information System [OXMIS] codes) in the General Practice Research Database (GPRD) study cohort. Entry into the GPRD study cohort began Jan 1, 1993, or at the time of GPRD registration if after Jan 1, 1993. Subjects were required to have at least 2 years of follow-up prior to the index date. The index date for cases was the date of incident pancreatic cancer diagnosis. Exocrine pancreatic cancer, endocrine pancreatic cancer, and carcinoma in situ were included. Cancer metastatic to the pancreas was excluded.
882853|NCT01138111|B1|Baseline|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
882854|NCT01138111|P1|Participant Flow|MCI Subjects|Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection of 300 megaBecqerels (MBq) florbetaben, at baseline, at 12 and 24 months
882855|NCT01138111|O6|Outcome|24 Month 90 Min|24 month PET scan at 90 min post-injection
882856|NCT01138111|O5|Outcome|24 Month 45 Min|24 month PET scan at 45 min post-injection
882857|NCT01138111|O4|Outcome|12 Month 90 Min|12 month PET scan at 90 min post-injection
882858|NCT01138111|O3|Outcome|12 Month 45 Min|12 month PET scan at 45 min post-injection
882859|NCT01138111|O2|Outcome|Baseline 90 Min|Baseline PET scan at 90 min post-injection
882860|NCT01138111|O1|Outcome|Baseline 45 Min|Baseline PET scan at 45 min post-injection
882861|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|24 month PET scan results for subjects who progressed to AD within the two year follow up period
882862|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|24 month scan results for subjects who did not progress to AD through the end of the two year follow up period
882863|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|12 month PET scan results for subjects who progressed to AD within the two year follow up period
882864|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|12 month PET scan results for subjects who did not progress to AD through the end of the two year follow up period
882865|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Baseline PET scan results for subjects who progressed to AD within the two year follow up period
882866|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Baseline PET scan results for subjects who did not progress to AD through the end of the two year follow up period
882867|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Results from 24 month scan for participants with progression from MCI to AD within 2 years after baseline scan.
882868|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Results from 24 month scan for participants with no progression to AD within 2 years after baseline scan.
882871|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Results from baseline scan for participants with progression from MCI to AD within 2 years after baseline scan.
882872|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Results from baseline scan for participants with no progression to AD within 2 years after baseline scan
882873|NCT01138111|O6|Outcome|Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who progressed to AD during the study
882874|NCT01138111|O5|Outcome|Not Progressed to AD (24 Month)|Mean SUVR for the 24 month PET scan in subjects who did not progress to AD during the study
882875|NCT01138111|O4|Outcome|Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who progressed to AD during the study
882876|NCT01138111|O3|Outcome|Not Progressed to AD (12 Month)|Mean SUVR for the 12 month PET scan in subjects who did not progress to AD during the study
882877|NCT01138111|O2|Outcome|Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who progressed to AD during the study
882878|NCT01138111|O1|Outcome|Not Progressed to AD (Baseline)|Mean SUVR for the baseline PET scan in subjects who did not progress to AD during the study
882879|NCT01138111|E3|Reported Event|MCI Subjects (2nd Repeat Drug Administration)|Subjects with AEs following the third administration of florbetaben (BAY94-9172) at the 24 month visit
882880|NCT01138111|E2|Reported Event|MCI Subjects (1st Repeat Drug Administration)|Subjects with AEs following the second administration of florbetaben (BAY94-9172) at the 12 month visit
882881|NCT01138111|E1|Reported Event|MCI Subjects (Initial Drug Administration)|Subjects with AEs following the initial administration of florbetaben (BAY94-9172) at the baseline visit
882882|NCT01138098|B3|Baseline|Total|Total of all reporting groups
882883|NCT01138098|B2|Baseline|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882884|NCT01138098|B1|Baseline|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882885|NCT01138098|P2|Participant Flow|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882886|NCT01138098|P1|Participant Flow|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882887|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882888|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882889|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882890|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882891|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882892|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882893|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882894|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882895|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882896|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882897|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882960|NCT01138007|E1|Reported Event|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882961|NCT01137812|B3|Baseline|Total|Total of all reporting groups
882898|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882899|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882900|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882901|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882902|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882903|NCT01138098|O2|Outcome|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882904|NCT01138098|O1|Outcome|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882905|NCT01138098|E2|Reported Event|Infanrix-IPV+Hib/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-IPV+Hib and Engerix-B vaccines in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882906|NCT01138098|E1|Reported Event|Infanrix-hexa/Engerix-B Group|Subjects aged 11-12 year old received 3 doses of Infanrix-hexa vaccine in the primary study (NCT01457495) and a challenge dose of Engerix-B vaccine in this study. Engerix-B was administered as a single dose intramuscularly into the deltoid region of the non-dominant arm.
882907|NCT01138046|B1|Baseline|Lapatinib 1500mg + Paclitaxel 80mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882908|NCT01138046|P1|Participant Flow|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 milligrams (mg) once daily (QD) in combination with intravenous (IV) paclitaxel (80 milligrams per meters squared [mg/m^2]) weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882909|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882910|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882911|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882912|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882913|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882914|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882915|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882916|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882917|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882918|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882919|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882920|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882921|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882922|NCT01138046|O1|Outcome|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882923|NCT01138046|E1|Reported Event|Lapatinib 1500 mg + Paclitaxel 80 mg/m^2|Participants received lapatinib 1500 mg QD in combination with IV paclitaxel 80 mg/m^2 weekly on Day 1, Day 8, and Day 15 of a 4-week cycle until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent.
882924|NCT01138007|B4|Baseline|Total|Total of all reporting groups
882925|NCT01138007|B3|Baseline|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882926|NCT01138007|B2|Baseline|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882927|NCT01138007|B1|Baseline|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882928|NCT01138007|P3|Participant Flow|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882929|NCT01138007|P2|Participant Flow|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882930|NCT01138007|P1|Participant Flow|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882931|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882932|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882933|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882934|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882935|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882936|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882937|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882938|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882939|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882962|NCT01137812|B2|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882963|NCT01137812|B1|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
883165|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
882940|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882941|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882942|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882943|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882944|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882945|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882946|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882947|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882948|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882949|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882950|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882951|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882952|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882953|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882954|NCT01138007|O1|Outcome|Placebo|A 323U66 SR placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882955|NCT01138007|O3|Outcome|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882956|NCT01138007|O2|Outcome|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882957|NCT01138007|O1|Outcome|Placebo|A 323U66 sustained release (SR) placebo tablet was administered orally twice daily, in the morning and the evening (Dose level 1 and 2), for 8 weeks.
882958|NCT01138007|E3|Reported Event|323U66 SR 300 mg|A 323U66 SR 150 mg tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses, during the first week of the Treatment Phase (Dose level 1). At Week 2, participants were up-titrated to a daily dose of 323U66 SR 300 mg, administered as a 323U66 SR 150 mg tablet twice daily, in the morning and in the evening, with an interval of at least 8 hours between successive doses (Dose level 2). Dose level 2 was maintained from Week 2 to Week 8.
882959|NCT01138007|E2|Reported Event|323U66 SR 150 mg|A 323U66 SR 150 milligram (mg) tablet was administered orally once in the morning, and a 323U66 SR 150 mg placebo tablet was administered orally once in the evening, with an interval of at least 8 hours between successive doses (Dose level 1 and 2), for 8 weeks.
882964|NCT01137812|P2|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882965|NCT01137812|P1|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882966|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882967|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882968|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882969|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882970|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882971|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882972|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882973|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882974|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882975|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882976|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882977|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882978|NCT01137812|O2|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882979|NCT01137812|O1|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882980|NCT01137812|E2|Reported Event|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882981|NCT01137812|E1|Reported Event|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once a day for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
882982|NCT01137786|B3|Baseline|Total|Total of all reporting groups
882983|NCT01137786|B2|Baseline|Iopamidol 370 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
882984|NCT01137786|B1|Baseline|Iodixanol 320 NGAL Evaluable Population|Non-ionic contrast media comparator: one time administration for PCI
882985|NCT01137786|P2|Participant Flow|Iopamidol 370|Non ionic contrast media comparator : one time administration for PCI
882986|NCT01137786|P1|Participant Flow|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
882987|NCT01137786|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iopamidol 370.
882988|NCT01137786|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370.
882989|NCT01137786|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320.
882990|NCT01137786|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320.
882991|NCT01137786|E2|Reported Event|Iopamidol 370|Non ionic contrast media comparator : One time administration for PCI
882992|NCT01137786|E1|Reported Event|Iodixanol 320|Non ionic contrast media comparator : one time administration for PCI
882993|NCT01137682|B4|Baseline|Total|Total of all reporting groups
882994|NCT01137682|B3|Baseline|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
882995|NCT01137682|B2|Baseline|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
882996|NCT01137682|B1|Baseline|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
882997|NCT01137682|P3|Participant Flow|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
882998|NCT01137682|P2|Participant Flow|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
882999|NCT01137682|P1|Participant Flow|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
883000|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
883001|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
883002|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
883003|NCT01137682|O3|Outcome|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
883004|NCT01137682|O2|Outcome|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
883005|NCT01137682|O1|Outcome|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
883006|NCT01137682|E3|Reported Event|Control Arm (Octreotide or Lanreotide)|If a patient is randomized to the open label arm the investigator will either: • be instructed to contact a Novartis delegate to initiate shipment of either octreotide LAR 30 mg or lanreotide ATG 120 mg from a Novartis or designee depot to the site, or • continue to dispense either octreotide LAR 30 mg or lanreotide ATG 120 mg available at the institution to the patient if permitted by local regulations.
883007|NCT01137682|E2|Reported Event|Pasireotide LAR 60 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
883008|NCT01137682|E1|Reported Event|Pasireotide LAR 40 mg|Supplied in blinded fashion as 20 and 40 mg powder in vials and 2 mL vehicle in ampoule (for reconstitution)
883009|NCT01137604|B5|Baseline|Total|Total of all reporting groups
883010|NCT01137604|B4|Baseline|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883011|NCT01137604|B3|Baseline|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883012|NCT01137604|B2|Baseline|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883013|NCT01137604|B1|Baseline|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883014|NCT01137604|P4|Participant Flow|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883015|NCT01137604|P3|Participant Flow|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883016|NCT01137604|P2|Participant Flow|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883017|NCT01137604|P1|Participant Flow|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883018|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883019|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883020|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883021|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883022|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883023|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883024|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883025|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883026|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883027|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883028|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883029|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883030|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883031|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883032|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883033|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883034|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883035|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883036|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883037|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883038|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883039|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883040|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883041|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883042|NCT01137604|O4|Outcome|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883043|NCT01137604|O3|Outcome|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883044|NCT01137604|O2|Outcome|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883045|NCT01137604|O1|Outcome|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883046|NCT01137604|E4|Reported Event|Cohort 3 - Lenvatinib|Participants with recurrent GBM who had disease progression following prior bevacizumab treatment; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883047|NCT01137604|E3|Reported Event|Cohort 2 - Lenvatinib|Participants with recurrent Grade 3 malignant glioma who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883048|NCT01137604|E2|Reported Event|Cohort 1 - Lenvatinib|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received lenvatinib capsules 24 mg taken orally, once daily continuously in 28-day cycles
883049|NCT01137604|E1|Reported Event|Cohort 1 - Bevacizumab|Participants with recurrent Grade 4 malignant glioma (ie, glioblastoma [GBM]) who were bevacizumab-naive; received bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles
883050|NCT01137578|B1|Baseline|All Imaged Participants|Baseline parameters for all participants in Cohorts A, B, and C: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883051|NCT01137578|P3|Participant Flow|Sub-Study Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
883052|NCT01137578|P2|Participant Flow|Cohort B|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT based on radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without gadolinium contrast enhancement) were to be done within 48 hours of each other or, for those with therapeutic anticoagulation, within 24 hours. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT.
883064|NCT01137578|O3|Outcome|Cohort C|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC-related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
883166|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883053|NCT01137578|P1|Participant Flow|Cohort A|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was recently placed and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Imaging procedures occurred on Day 40 ± 20 days relative to catheter placement (Day 0) and included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used for MRI with contrast. No sedation or anesthesia was to be allowed. Participants who developed symptoms of VTE prior to imaging should have been switched to Cohort B.
883054|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883055|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
883056|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
883057|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
883058|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883059|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883060|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883061|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
883062|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
883063|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
883167|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
884014|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
883065|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883066|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, should have been switched to Cohort B.
883067|NCT01137578|O4|Outcome|All Imaged Participants: No MRI With Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI with contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883068|NCT01137578|O3|Outcome|All Imaged Participants: No MRI Without Contrast Performed|Participant had at least one radiographic imaging procedure performed but no study-related MRI without contrast was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883069|NCT01137578|O2|Outcome|All Imaged Participants: Unilateral Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but a study-related unilateral US instead of a bilateral US was completed. Bilateral US was the protocol-defined procedure but if the participant was not able to complete a bilateral US, then the unilateral US was accepted for evaluation. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883070|NCT01137578|O1|Outcome|All Imaged Participants: No Ultrasound Performed|Participant had at least one radiographic imaging procedure performed but no study-related US (either bilateral or unilateral) was performed. Pediatric participants in which a CVC was to be placed or who had a CVC in place were included. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883071|NCT01137578|O6|Outcome|Cohort C Participants 12Years to 18 Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
883072|NCT01137578|O5|Outcome|Cohort C Participants <12Years of Age|A Sub-study with additional cohort C was initiated to collect diagnostic imaging procedures for the detection of CVC related DVT in a population < 18 years of age who had a CVC in place and who were scheduled to undergo a contrast enhanced MRI in any part of their body as part of their clinical care and who allowed the diagnostic imaging procedure to include the area around the CVC.
883073|NCT01137578|O4|Outcome|Cohort B Participants 12Years to 18 Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883074|NCT01137578|O3|Outcome|Cohort B Participants <12Years of Age|Cohort B included pediatric participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons. Diagnostic imaging procedures, US and MRI (with and without contrast enhancement) were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883103|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883237|NCT01136954|B3|Baseline|Total|Total of all reporting groups
883075|NCT01137578|O2|Outcome|Cohort A Participants 12Years to 18 Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
883076|NCT01137578|O1|Outcome|Cohort A Participants <12Years of Age|Cohort A included pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT). Diagnostic imaging procedures included: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was allowed.
883077|NCT01137578|O3|Outcome|Cohort C|Participants with a CVC in place and having an MRI for clinical reasons were enrolled.
883078|NCT01137578|O2|Outcome|Cohort B|Pediatric Participants (full-term newborns to <18 years) with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883079|NCT01137578|O1|Outcome|Cohort A|Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia to be allowed. Participants enrolled in Cohort A and who developed symptoms of a venous thromboembolism (VTE), including a symptomatic DVT or a symptomatic pulmonary embolism (PE) prior to their MRI/US, were switched to Cohort B.
883080|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883081|NCT01137578|O9|Outcome|Cohort C 12Years to <18Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
883082|NCT01137578|O8|Outcome|Cohort C 2Years to <12Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
883083|NCT01137578|O7|Outcome|Cohort C Newborn to <2Years|Pediatric participants with a CVC in place and having an MRI for clinical reasons were enrolled were enrolled in the substudy, Cohort C. An ultrasound was to be performed around the area of the CVC within 48 hours of the MRI. The MRI was performed both with and without contrast.
883084|NCT01137578|O6|Outcome|Cohort B 12Years to <18Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883085|NCT01137578|O5|Outcome|Cohort B 2Years to <12Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883104|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883105|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883086|NCT01137578|O4|Outcome|Cohort B Newborn to <2Years|Pediatric participants with a CVC and who were either symptomatic for a CVC-related DVT or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons were enrolled into Cohort B. Diagnostic imaging procedures, US and MRI, were performed with and without contrast enhancement and were to be done within 48 hours of each other. Aesthesia/sedation allowed as routine standard of care for participants only if symptomatic for a CVC-related DVT. For those participants symptomatic for a CVC-related DVT, MRI and US were to be initiated within 7 days of symptoms. In those participants with an incidental diagnosis of a CVC-related DVT made by radiographic imaging performed for clinical reasons, MRI and US were to be done within 7 days of the diagnosis of the CVC-related DVT. If anticoagulation was started, ultrasound and MRI were to be done within 24 hours of each other.
883087|NCT01137578|O3|Outcome|Cohort A 12Years to <18Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
883088|NCT01137578|O2|Outcome|Cohort A 2Years to <12Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
883089|NCT01137578|O1|Outcome|Cohort A Newborn to <2Years|Pediatric participants in which a CVC was to be placed (intended stay for 40 ± 20 days) and who were asymptomatic for CVC-related deep vein thrombosis (DVT) were included in Cohort A. Diagnostic imaging procedures: ultrasound (US) and magnetic resonance imaging (MRI), with and without contrast enhancement. The MRI and US were to be done within 48 hours of each other. An approved gadolinium contrast agent at a dose which was considered ‘state-of-the-art’ or standard institutional practice at the specific site and in accordance with the country-specific regulatory guidance was to be used. No sedation or anesthesia was to be allowed.
883090|NCT01137578|O1|Outcome|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883091|NCT01137578|E1|Reported Event|All Imaged Participants|All participants in Cohorts A, B, and C who had at least 1 radiographic procedure: Pediatric participants (full-term newborns to <18 years) in which a CVC was to be placed or who had a CVC in place. Participants were either asymptomatic (cohort A) or symptomatic for CVC-related deep vein thrombosis (DVT) or had an incidental diagnosis of CVC-related DVT by radiographic imaging performed for other clinical reasons (cohort B) or participants with a CVC in place and having an MRI with contrast for clinical reasons (Sub-study, cohort C).
883092|NCT01137474|B5|Baseline|Total|Total of all reporting groups
883093|NCT01137474|B4|Baseline|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883094|NCT01137474|B3|Baseline|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
883095|NCT01137474|B2|Baseline|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
883096|NCT01137474|B1|Baseline|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883097|NCT01137474|P4|Participant Flow|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883098|NCT01137474|P3|Participant Flow|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
883099|NCT01137474|P2|Participant Flow|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
883100|NCT01137474|P1|Participant Flow|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883101|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883102|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883162|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883106|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883107|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883108|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883109|NCT01137474|O2|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883110|NCT01137474|O1|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883111|NCT01137474|O2|Outcome|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883112|NCT01137474|O1|Outcome|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883113|NCT01137474|E4|Reported Event|Dapagliflozin 10 mg|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 10 mg, daily with a morning meal.
883114|NCT01137474|E3|Reported Event|Dapagliflozin, 5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 5 mg, daily with a morning meal.
883115|NCT01137474|E2|Reported Event|Dapagliflozin, 2.5 mg (Randomized Before Protocol Amendment 8)|Participants with type 2 diabetes and inadequate glycemic control while taking an OAD with or without insulin and an ACE inhibitor or ARB, received dapagliflozin, 2.5 mg, daily with a morning meal.
883116|NCT01137474|E1|Reported Event|Placebo|Participants with type 2 diabetes and inadequate glycemic and hypertension control while taking an oral antidiabetic drug (OAD) with or without insulin and an angiotensin-converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB), received dapagliflozin-matching placebo daily with a morning meal.
883117|NCT01137435|B1|Baseline|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
883118|NCT01137435|P1|Participant Flow|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
883119|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
883120|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
883121|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
883122|NCT01137435|O1|Outcome|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
883123|NCT01137435|E1|Reported Event|Study Subjects|Participants who had returned case report forms and included in the safety analysis.
883124|NCT01137396|B3|Baseline|Total|Total of all reporting groups
883125|NCT01137396|B2|Baseline|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883126|NCT01137396|B1|Baseline|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883127|NCT01137396|P2|Participant Flow|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883128|NCT01137396|P1|Participant Flow|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883129|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883130|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883131|NCT01137396|O2|Outcome|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883132|NCT01137396|O1|Outcome|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883133|NCT01137396|E2|Reported Event|Placebo|"Placebo: Placebo medication Qdaily for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883134|NCT01137396|E1|Reported Event|Modafinil|"Modafinil: Modafinil 400mg PO QDaily following up-titration for ~8weeks~Cognitive Behavioral Therapy: Once weekly cognitive behavioral therapy for cocaine dependence"
883135|NCT01137370|B3|Baseline|Total|Total of all reporting groups
883136|NCT01137370|B2|Baseline|People Without TB|
883137|NCT01137370|B1|Baseline|Patients With TB|
883138|NCT01137370|P2|Participant Flow|People Without TB|
883139|NCT01137370|P1|Participant Flow|Patients With TB|
883140|NCT01137370|O2|Outcome|People Without TB|
883141|NCT01137370|O1|Outcome|Patients With TB|
883142|NCT01137370|E2|Reported Event|People Without TB|
883143|NCT01137370|E1|Reported Event|Patients With TB|
884015|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883144|NCT01137292|B1|Baseline|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
883145|NCT01137292|P1|Participant Flow|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
883146|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
883147|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
883148|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
883149|NCT01137292|O1|Outcome|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
883150|NCT01137292|E1|Reported Event|Voriconazole|"In adults, treatment was started with the loading dose of 6 mg/kg of voriconazole intravenously every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg twice a day (BID). Adults with a weight of >40 kg receiving the oral formulation received a loading dose of 400 mg BID during the first 24 hours, followed by a maintenance dose of 200 mg BID for the duration of the study.~Adults with a weight of <40 kg receiving the oral formulation received a loading dose of 200 mg BID during the first 24 hours, followed by a maintenance dose of 100 mg BID for the duration of the study. Pediatric participants under 12 years of age received 7 mg/kg IV BID or 200 mg orally BID for the duration of the study. A loading dose was not required in participants under 12 years of age."
883151|NCT01137071|B1|Baseline|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883152|NCT01137071|P1|Participant Flow|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883153|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883154|NCT01137071|O1|Outcome|Pharmacokinetic|All patients enrolled in the study that received at least 9 doses of investigational product were considered to this analysis.
883155|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883156|NCT01137071|O1|Outcome|Monoclonal Antibody hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883157|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883158|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883159|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883160|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883161|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
892168|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
883168|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883169|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883170|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883171|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883172|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883173|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883174|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883175|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883176|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883177|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883178|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883179|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883180|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883181|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883182|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883183|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883184|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883185|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883186|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883187|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883188|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883189|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883190|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.~Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
883191|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883192|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883193|NCT01137071|O1|Outcome|hu3S193|"Monoclonal antibody hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.~Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
883194|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883195|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883196|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883197|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883198|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883199|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks.
883200|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883201|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883202|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883203|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883204|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883205|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883206|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883207|NCT01137071|O1|Outcome|hu3S193|hu3S193 was administered to 29 patients at the dose of 30mg/m2 every other week (total of 12 infusions) for a total of 23 weeks.
883208|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883209|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883210|NCT01137071|O1|Outcome|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883211|NCT01137071|E1|Reported Event|hu3S193|hu3S193: 30mg/m2, intravenous, every other week (total of 12 infusions) for a total of 23 weeks
883212|NCT01137032|B1|Baseline|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
883213|NCT01137032|P1|Participant Flow|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
883214|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
883215|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
883216|NCT01137032|O1|Outcome|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
883217|NCT01137032|E1|Reported Event|Pandel Cream 0.1%|Pandel Cream 0.1%: A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
883218|NCT01136967|B3|Baseline|Total|Total of all reporting groups
883219|NCT01136967|B2|Baseline|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883220|NCT01136967|B1|Baseline|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883221|NCT01136967|P2|Participant Flow|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883222|NCT01136967|P1|Participant Flow|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883223|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883224|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883225|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883226|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883227|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883228|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883229|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883230|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883231|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883232|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883233|NCT01136967|O2|Outcome|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883234|NCT01136967|O1|Outcome|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883235|NCT01136967|E2|Reported Event|Cohort 2 (V600E BRAF Positive)|Cohort 2 (V600E BRAF positive) enrolled participants harboring the activating BRAF mutations (mainly the V600E mutation) with disease progression following BRAF V600E-targeted therapy. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883236|NCT01136967|E1|Reported Event|Cohort 1 (V600E BRAF Negative)|Cohort 1 (V600E BRAF negative) enrolled participants not harboring the V600E BRAF mutation with disease progression following up to 2 prior systemic anticancer regimens (excluding anti-VEGF) for unresectable Stage III or Stage IV melanoma. Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles.
883238|NCT01136954|B2|Baseline|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
883239|NCT01136954|B1|Baseline|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
883240|NCT01136954|P2|Participant Flow|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
883241|NCT01136954|P1|Participant Flow|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
883242|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
883243|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
883244|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
883245|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
883246|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
883247|NCT01136954|O1|Outcome|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
883248|NCT01136954|O2|Outcome|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
883249|NCT01136954|O1|Outcome|Zonisamide (Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
883250|NCT01136954|E2|Reported Event|Zonisamide (Zonisamide During Core Study)|Participants previously receiving zonisamide in Study 312 continued taking the same dose of study drug (8 mg/kg/day),supplemented with an increasing number of placebo capsules to mirror the up-titration regimen being followed by those previously receiving placebo.Down-titration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period.Subsequently, a 45-57 week Open-label period followed.
883251|NCT01136954|E1|Reported Event|Zonisamide(Placebo During Core Study)|Participants previously receiving placebo in Study 312, started dosing with zonisamide with a dose of 1 mg/kg/day and titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Transition Period (weeks 2 -11). Downtitration was allowed between the limits of 1 to 8 mg/kg/day during Transition Period. Subsequently, a 45-57 week Open-label period followed. Placebo dosing ceased in Open-label Period.
883252|NCT01136915|B3|Baseline|Total|Total of all reporting groups
883253|NCT01136915|B2|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
883294|NCT01136772|P1|Participant Flow|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
883254|NCT01136915|B1|Baseline|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single intravenous administration for percutaneous coronary intervention procedure; dose was limited to the minimum volume required to achieve diagnostic information and/or guide therapeutic intervention.
883255|NCT01136915|P2|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
883256|NCT01136915|P1|Participant Flow|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
883257|NCT01136915|O4|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iodixanol 320
883258|NCT01136915|O3|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
883259|NCT01136915|O2|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
883260|NCT01136915|O1|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
883261|NCT01136915|E2|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
883262|NCT01136915|E1|Reported Event|Iopamidol 370|Iopamidol 370: Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
883263|NCT01136876|B3|Baseline|Total|Total of all reporting groups
883264|NCT01136876|B2|Baseline|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
883265|NCT01136876|B1|Baseline|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
883266|NCT01136876|P2|Participant Flow|Iopamidol 370|Iopamidol 370 Non-ionic low-osmolar iodinated contrast media: single administration for percutaneous coronary intervention procedure
883267|NCT01136876|P1|Participant Flow|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
883268|NCT01136876|O4|Outcome|Iopamidol 370 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24,and 48 hours post-administration of iopamidol 370
883269|NCT01136876|O3|Outcome|Iopamidol 370 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iopamidol 370
883270|NCT01136876|O2|Outcome|Iodixanol 320 Urine NGAL|Urine NGAL (ng/mL) mean change from baseline at 2,4,6,24, and 48 hours post-administration of iodixanol 320
883271|NCT01136876|O1|Outcome|Iodixanol 320 Serum NGAL|Serum NGAL (ng/mL) mean change from baseline at 2,4,6,24,48, and 72 hours post-administration of iodixanol 320
883272|NCT01136876|E2|Reported Event|Iopamidol 370|Iopamidol 370 Non-ionic low osmolar iodinated contrast media: single administration for percutaneous coronary intervention
883273|NCT01136876|E1|Reported Event|Iodixanol 320|Iodixanol 320 Non-ionic iso-osmolar iodinated contrast media comparator: single administration for percutaneous coronary intervention procedure
883274|NCT01136785|B3|Baseline|Total|Total of all reporting groups
883275|NCT01136785|B2|Baseline|Sham CPAP|7 days of sham CPAP in the laboratory.
883276|NCT01136785|B1|Baseline|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
883277|NCT01136785|P2|Participant Flow|Sham CPAP|7 days of sham CPAP in the laboratory.
883278|NCT01136785|P1|Participant Flow|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
883279|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 8 participants who had complete 24-h profiles of plasma norepinephrine before and after treatment with active CPAP.
883280|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 12 participants who had complete 24-h profiles of glucose, insulin and counter-regulatory hormones before and after treatment with active CPAP.
883281|NCT01136785|O1|Outcome|Active CPAP|The goal of the present analysis is to explore mechanisms by which CPAP therapy led to improvement in the 24-h glucose levels. We focus on the 12 participants who had complete 24-h profiles of glucose, insulin and counter-regulatory hormones before and after treatment with active CPAP.
883282|NCT01136785|O2|Outcome|CPAP|7 days of sham CPAP in the laboratory.
883283|NCT01136785|O1|Outcome|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
883284|NCT01136785|O2|Outcome|Sham CPAP|7 days of sham CPAP in the laboratory.
883285|NCT01136785|O1|Outcome|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
883286|NCT01136785|O2|Outcome|Sham CPAP|7 days of sham CPAP in the laboratory.
883287|NCT01136785|O1|Outcome|Active CPAP|7 days of treatment in the laboratory with active CPAP. Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea
883288|NCT01136785|E2|Reported Event|Sham CPAP|7 days of sham CPAP in the laboratory.
883289|NCT01136785|E1|Reported Event|Active CPAP|"7 days of treatment in the laboratory with active CPAP.~Continuous Positive Airway Pressure (CPAP) Therapy (active): CPAP is approved for the treatment of Obstructive Sleep Apnea"
883290|NCT01136772|B3|Baseline|Total|Total of all reporting groups
883291|NCT01136772|B2|Baseline|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
883292|NCT01136772|B1|Baseline|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
883293|NCT01136772|P2|Participant Flow|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
883295|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
883296|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
883297|NCT01136772|O2|Outcome|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
883298|NCT01136772|O1|Outcome|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
883299|NCT01136772|E2|Reported Event|Haloperidol Decanoate|Intramuscular injections of haloperidol decanoate 25-200 mg every month
883300|NCT01136772|E1|Reported Event|Paliperidone Palmitate|Intramuscular injections of paliperidone palmitate 39-234 mg every month
883301|NCT01136746|B3|Baseline|Total|Total of all reporting groups
883302|NCT01136746|B2|Baseline|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883303|NCT01136746|B1|Baseline|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883304|NCT01136746|P2|Participant Flow|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883305|NCT01136746|P1|Participant Flow|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883306|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883307|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883308|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883309|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883310|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883311|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883312|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883313|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883314|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883315|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883316|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883317|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883318|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883319|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883320|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883321|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883374|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
883322|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883323|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883324|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883325|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883326|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883327|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883328|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883329|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883330|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883331|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883332|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883333|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883334|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883335|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883336|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883337|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883338|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883339|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883340|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883341|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883342|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883343|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883344|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883375|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
883345|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883346|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883347|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883348|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883349|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883350|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883351|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883352|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883353|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883354|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883355|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883356|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883357|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883358|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883359|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883360|NCT01136746|O2|Outcome|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883361|NCT01136746|O1|Outcome|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883362|NCT01136746|E2|Reported Event|Basal-bolus Therapy|"Insulin lispro: Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization).~Insulin glargine: Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)."
883363|NCT01136746|E1|Reported Event|Sliding Scale Regular Insulin|Human regular insulin: Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization).
883364|NCT01136655|B1|Baseline|Randomized Patients|All randomized patients
883365|NCT01136655|P1|Participant Flow|Randomized Patients|All randomized patients
883366|NCT01136655|O4|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
883367|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
883368|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
883369|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
883370|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
883371|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
883372|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
883373|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
883489|NCT01136356|O1|Outcome|Morphine|
883376|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
883377|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
883378|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
883379|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
883380|NCT01136655|O5|Outcome|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
883381|NCT01136655|O4|Outcome|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
883382|NCT01136655|O3|Outcome|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
883383|NCT01136655|O2|Outcome|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
883384|NCT01136655|O1|Outcome|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
883385|NCT01136655|E5|Reported Event|BUD 160/ Foradil 12.0|Foradil Aerolizer 12 μg x 1 inhalation + 80 μg budesonide HFA pMDI × 2 inhalations
883386|NCT01136655|E4|Reported Event|BUD 160|placebo HFA pMDI x 1 inhalation + 80 μg budesonide HFA pMDI x 2 inhalations
883387|NCT01136655|E3|Reported Event|BUD 160/FM 9.0|placebo HFA pMDI x 1 inhalation + 9 μg formoterol (as 80/4.5 μg Symbicort pMDI x 2 inhalations)
883388|NCT01136655|E2|Reported Event|BUD 160/FM 4.5|placebo HFA pMDI x 1 inhalation + 4.5 μg formoterol (as 80/2.25 μg Symbicort pMDI x 2 inhalations)
883389|NCT01136655|E1|Reported Event|BUD 160/FM 2.25|2.25 μg formoterol (as 80/2.25 μg Symbicort pMDI x 1 inhalation) + 40 μg budesonide HFA pMDI × 2 inhalations
883390|NCT01136486|B1|Baseline|Level of Severity of TBI|Four categories based on pain severity (no pain, mild, moderate and severe pain).
883391|NCT01136486|P1|Participant Flow|Treatment Arm|Pain was assessed with the Visual Analog Scale and patients underwent a brief battery of tests that included assessment of neuropsychological functions, mood, anxiety and community functions.
883392|NCT01136486|O1|Outcome|Severity of Pain by Severity of Injury|
883393|NCT01136486|E1|Reported Event|Severity of Pain by Severity of Injury|
883394|NCT01136408|B4|Baseline|Total|Total of all reporting groups
883395|NCT01136408|B3|Baseline|Warfarin|Dose-adjusted warfarin based on target INR values
883396|NCT01136408|B2|Baseline|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883397|NCT01136408|B1|Baseline|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883398|NCT01136408|P3|Participant Flow|Warfarin|Dose-adjusted warfarin based on target INR values
883399|NCT01136408|P2|Participant Flow|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883400|NCT01136408|P1|Participant Flow|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883401|NCT01136408|O3|Outcome|Warfarin|"Dose-adjusted warfarin based on target INR values~Warfarin: Dose-adjusted warfarin based on target INR values"
883402|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|"Dabigatran etexilate 150 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 150 mg capsule, twice a day, oral administration"
883403|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|"Dabigatran etexilate 110 mg capsule, twice a day, oral administration~Dabigatran etexilate: Dabigatran etexilate 110 mg capsule, twice a day, oral administration"
883404|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883405|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883406|NCT01136408|O3|Outcome|Warfarin|
883407|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883408|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883409|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883410|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883411|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883412|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883413|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883414|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883415|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883416|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883417|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883418|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883419|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883420|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883421|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883422|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883423|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883424|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883425|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883490|NCT01136356|O2|Outcome|Buprenorphine|
883426|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883427|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883428|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883429|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883430|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883431|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883432|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883433|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883434|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883435|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883436|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883437|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883438|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883439|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883440|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883441|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883442|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883443|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883444|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883445|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883446|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883447|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883448|NCT01136408|O3|Outcome|Warfarin|Dose-adjusted warfarin based on target INR values
883449|NCT01136408|O2|Outcome|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883450|NCT01136408|O1|Outcome|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883451|NCT01136408|E3|Reported Event|Warfarin|Dose-adjusted warfarin based on target INR values
883452|NCT01136408|E2|Reported Event|Dabigatran Etexilate 300 mg Daily|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
883453|NCT01136408|E1|Reported Event|Dabigatran Etexilate 220 mg Daily|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
883454|NCT01136382|B3|Baseline|Total|Total of all reporting groups
883455|NCT01136382|B2|Baseline|Budesonide|Budesonide pMDI 160 mcg bid
883456|NCT01136382|B1|Baseline|Placebo|Placebo pMDI bid
883457|NCT01136382|P2|Participant Flow|Budesonide|Budesonide pMDI 160 mcg bid
883458|NCT01136382|P1|Participant Flow|Placebo|Placebo pMDI bid
883459|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883460|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883461|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883462|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883463|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883464|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883465|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883466|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883467|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883468|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883469|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883470|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883471|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883472|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883473|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883474|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883475|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883476|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883477|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883478|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883479|NCT01136382|O2|Outcome|Budesonide|Budesonide pMDI 160 mcg bid
883480|NCT01136382|O1|Outcome|Placebo|Placebo pMDI bid
883481|NCT01136382|E2|Reported Event|Placebo pMDI b.i.d.|
883482|NCT01136382|E1|Reported Event|Budesonide pMDI 160mcg b.i.d.|
883483|NCT01136356|B1|Baseline|Within Subjects Design|Participants received both study drugs (buprenorphine and morphine) in a randomized sequence.
883484|NCT01136356|P2|Participant Flow|Buprenorphine First, Then Morphine|Participants randomized to receive buprenorphine (32 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using morphine (120 mg/day i.m.) with the same time course
883485|NCT01136356|P1|Participant Flow|Morphine First, Then Buprenorphine|Participants randomized to receive morphine (120 mg/day i.m.) administered in four divide doses for 9 days. Then underwent an 18-day period of spontaneous withdrawal, during which 4 double blind i.m. placebo injections were administered daily. Then administered using buprenorphine (32 mg/day i.m.) with the same time course
883486|NCT01136356|O2|Outcome|Buprenorphine|
883487|NCT01136356|O1|Outcome|Morphine|
883488|NCT01136356|O2|Outcome|Buprenorphine|
883492|NCT01136356|E1|Reported Event|All Participants|The adverse events were not specified per drug intervention, therefore, the adverse events per interventions is unknown. The data below references the adverse events recorded by licensed nursing personnel during the participants' 59-day protocol in a residential research unit. All participants (N=7) were randomized to receive either buprenorphine (32 mg/day i.m.) or morphine (120 mg/day i.m.) administered in four divided doses each day for 9 days (8 mg of buprenorphine four times per day, or 30 mg of morphine four times per day). Participants then underwent an 18-day period of spontaneous opioid withdrawal, during which four double blind i.m. placebo injections were administered daily. After the period of spontaneous withdrawal, participants received the second opioid administration and spontaneous withdrawal period using the same time course described above.
883493|NCT01136291|B3|Baseline|Total|Total of all reporting groups
883494|NCT01136291|B2|Baseline|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
883495|NCT01136291|B1|Baseline|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
883496|NCT01136291|P2|Participant Flow|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
883497|NCT01136291|P1|Participant Flow|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
883498|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
883499|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
883500|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
883501|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
883502|NCT01136291|O2|Outcome|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
883503|NCT01136291|O1|Outcome|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
883504|NCT01136291|E2|Reported Event|no Exercise|The pregnant women in this group underwent routine prenatal. In addition to receiving nutritional counseling.
883505|NCT01136291|E1|Reported Event|Physical Exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.~These women also received nutrition and prenatal care."
883506|NCT01136226|B1|Baseline|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
883507|NCT01136226|P1|Participant Flow|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
883508|NCT01136226|O1|Outcome|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
883509|NCT01136226|E1|Reported Event|Single Arm- Eligard|Eligard 22.5mg is only intervention administered
883510|NCT01136174|B5|Baseline|Total|Total of all reporting groups
883511|NCT01136174|B4|Baseline|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883512|NCT01136174|B3|Baseline|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883513|NCT01136174|B2|Baseline|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883514|NCT01136174|B1|Baseline|Placebo|Placebo oral administration twice a day
883515|NCT01136174|P4|Participant Flow|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883516|NCT01136174|P3|Participant Flow|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883517|NCT01136174|P2|Participant Flow|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883518|NCT01136174|P1|Participant Flow|Placebo|Placebo oral administration twice a day
883519|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883520|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
883521|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883522|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
883523|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883524|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
883525|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883526|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
883527|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883529|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883530|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
883531|NCT01136174|O2|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883532|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 3
883533|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883534|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
883535|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
883536|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
883537|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883538|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
883539|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
883540|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
883541|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883542|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
883543|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
883544|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
883545|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883546|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883547|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883548|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883549|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883550|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883551|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883552|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883553|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883554|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883555|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883556|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883557|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883558|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883559|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883560|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883561|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883562|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883563|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883564|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883565|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883566|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883567|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883568|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883569|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883570|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883571|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883572|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883573|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883574|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883575|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883576|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883577|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883578|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883579|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883580|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883581|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883582|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883583|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883584|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883585|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883586|NCT01136174|O3|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883587|NCT01136174|O2|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883588|NCT01136174|O1|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883589|NCT01136174|O4|Outcome|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day
883590|NCT01136174|O3|Outcome|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day
883591|NCT01136174|O2|Outcome|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day
883592|NCT01136174|O1|Outcome|Placebo|Placebo oral administration twice a day
883593|NCT01136174|E4|Reported Event|BIBF 1120 150 mg|BIBF 1120 150 mg oral administration twice a day for cohort 3
883594|NCT01136174|E3|Reported Event|BIBF 1120 100 mg|BIBF 1120 100 mg oral administration twice a day for cohort 2
883595|NCT01136174|E2|Reported Event|BIBF 1120 50 mg|BIBF 1120 50 mg oral administration twice a day for cohort 1
883596|NCT01136174|E1|Reported Event|Placebo|Placebo oral administration twice a day for cohort 1, 2, 3
883597|NCT01135992|B1|Baseline|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883598|NCT01135992|P1|Participant Flow|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883599|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883600|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883601|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883602|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883603|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883604|NCT01135992|O1|Outcome|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883605|NCT01135992|E1|Reported Event|IGlar/IDeg|Subjects received 4 weeks of unchanged pre-trial insulin glargine (IGlar) once daily (OD) followed by 12 weeks of insulin degludec (IDeg) 200 U/mL 3 times weekly (3TW) subcutaneously, both in combination with unchanged pre-trial oral antidiabetic drug [OAD] treatment.
883606|NCT01135914|B4|Baseline|Total|Total of all reporting groups
883607|NCT01135914|B3|Baseline|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883608|NCT01135914|B2|Baseline|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883609|NCT01135914|B1|Baseline|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883610|NCT01135914|P3|Participant Flow|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883611|NCT01135914|P2|Participant Flow|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883612|NCT01135914|P1|Participant Flow|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883613|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883614|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883615|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883616|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883617|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883618|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883619|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883620|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883621|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883622|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883623|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883624|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883625|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883626|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883627|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883628|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883629|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883630|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883631|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883632|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883633|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883634|NCT01135914|O3|Outcome|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883635|NCT01135914|O2|Outcome|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883636|NCT01135914|O1|Outcome|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883637|NCT01135914|E3|Reported Event|Laser Monotherapy|Participants received Laser photocoagulation therapy only
883638|NCT01135914|E2|Reported Event|Ranibizumab Monotherapy|Participants received ranibizumab intravitreal injection therapy only
883639|NCT01135914|E1|Reported Event|Combination Therapy|Participants received both a ranibizumab intravitreal injection and laser photocoagulation treatments.
883640|NCT01135524|B1|Baseline|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
883641|NCT01135524|P1|Participant Flow|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
883642|NCT01135524|O1|Outcome|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
883643|NCT01135524|E1|Reported Event|Extension Phase|Open-label buprenorphine transdermal patch 5, 10, 20 mcg/h applied for 7-day wear
883644|NCT01135511|B10|Baseline|Total|Total of all reporting groups
883645|NCT01135511|B9|Baseline|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883646|NCT01135511|B8|Baseline|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883647|NCT01135511|B7|Baseline|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883648|NCT01135511|B6|Baseline|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883649|NCT01135511|B5|Baseline|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883650|NCT01135511|B4|Baseline|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883651|NCT01135511|B3|Baseline|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883652|NCT01135511|B2|Baseline|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883653|NCT01135511|B1|Baseline|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883654|NCT01135511|P9|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883655|NCT01135511|P8|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883656|NCT01135511|P7|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883657|NCT01135511|P6|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883658|NCT01135511|P5|Participant Flow|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883659|NCT01135511|P4|Participant Flow|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884016|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
884017|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
884018|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883660|NCT01135511|P3|Participant Flow|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883661|NCT01135511|P2|Participant Flow|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883662|NCT01135511|P1|Participant Flow|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883663|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883664|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883665|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883666|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883667|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883668|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883669|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883670|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883671|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883672|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883673|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883674|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883675|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883676|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883677|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883678|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
892169|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
883679|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883680|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883681|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883682|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883683|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883684|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883685|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883686|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883687|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883688|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883689|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883690|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883691|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883692|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883693|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883694|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883695|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883696|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883697|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884019|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883698|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883699|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883700|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883701|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883702|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883703|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883704|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883705|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883706|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883707|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883708|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883709|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883710|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883711|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883712|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883713|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883714|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883715|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883716|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884020|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
883717|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883718|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883719|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883720|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883721|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883722|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883723|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883724|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883725|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883726|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883727|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883728|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883729|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883730|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883731|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883732|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883733|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883734|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883735|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
892170|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
883736|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883737|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883738|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883739|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883740|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883741|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883742|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883743|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883744|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883745|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883746|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883747|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883748|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883749|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883750|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883751|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883752|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883753|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883754|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
892171|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
883755|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883756|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883757|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883758|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883759|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883760|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883761|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883762|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883763|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883764|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883765|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883766|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883767|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883768|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883769|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883770|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883771|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883772|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883773|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
892172|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
883774|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883775|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883776|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883777|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883778|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883779|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883780|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883781|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883782|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883783|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883784|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883785|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883786|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883787|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883788|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883789|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883790|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883791|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883792|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884021|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883793|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883794|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883795|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883796|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883797|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883798|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883799|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883800|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883801|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883802|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883803|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883804|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883805|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883806|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883807|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883808|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883809|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883810|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883811|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884022|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883812|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883813|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883814|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883815|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883816|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883817|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883818|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883819|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883820|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883821|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883822|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883823|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883824|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883825|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883826|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883827|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883828|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883829|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883830|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884023|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
883831|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883832|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883833|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883834|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883835|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883836|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883837|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883838|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883839|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883840|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883841|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883842|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883843|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883844|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883845|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883846|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883847|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883848|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883849|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884024|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883850|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883851|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883852|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883853|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883854|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883855|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883856|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883857|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883858|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883859|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883860|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883861|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883862|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883863|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883864|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883865|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883866|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883867|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883868|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884025|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883869|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883870|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883871|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883872|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883873|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883874|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883875|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883876|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883877|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883878|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883879|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883880|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883881|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883882|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883883|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883884|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883885|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883886|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883887|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
892173|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
883888|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883889|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883890|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883891|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883892|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883893|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883894|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883895|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883896|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883897|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883898|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883899|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883900|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883901|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883902|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883903|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883904|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883905|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883906|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
892174|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
883907|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883908|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883909|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883910|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883911|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883912|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883913|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883914|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883915|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883916|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883917|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883918|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883919|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883920|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883921|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883922|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883923|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883924|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883925|NCT01135511|O9|Outcome|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
884026|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
883926|NCT01135511|O8|Outcome|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883927|NCT01135511|O7|Outcome|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883928|NCT01135511|O6|Outcome|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883929|NCT01135511|O5|Outcome|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883930|NCT01135511|O4|Outcome|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883931|NCT01135511|O3|Outcome|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883932|NCT01135511|O2|Outcome|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883933|NCT01135511|O1|Outcome|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883934|NCT01135511|E9|Reported Event|CP-690,550 Eye Drops 0.005% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883935|NCT01135511|E8|Reported Event|CP-690,550 Eye Drops 0.003% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883936|NCT01135511|E7|Reported Event|CP-690,550 Eye Drops 0.001% Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883937|NCT01135511|E6|Reported Event|CP-690,550 Eye Drops Vehicle Group in Korea|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883938|NCT01135511|E5|Reported Event|Sodium Hyaluronate Eye Drops 0.1% Group in Japan|At baseline (Day 0), the participants were administered the first dose of sodium hyaluronate eye drops 0.1% and could instill sodium hyaluronate eye drops 0.1% up to 6 times a day (including the first dose). Participants instilled sodium hyaluronate eye drops 0.1% with 1 drop per time and 6 times daily for 8 weeks.
883939|NCT01135511|E4|Reported Event|CP-690,550 Eye Drops 0.005% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.005%. Participants instilled CP-690,550 eye drops 0.005% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883940|NCT01135511|E3|Reported Event|CP-690,550 Eye Drops 0.003% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.003%. Participants instilled CP-690,550 eye drops 0.003% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883941|NCT01135511|E2|Reported Event|CP-690,550 Eye Drops 0.001% Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops 0.001%. Participants instilled CP-690,550 eye drops 0.001% with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883942|NCT01135511|E1|Reported Event|CP-690,550 Eye Drops Vehicle Group in Japan|At baseline (Day 0), the participants were administered the first dose of CP-690,550 eye drops vehicle. Participants instilled CP-690,550 eye drops vehicle with 1 drop per time and once daily during the 8-week treatment period. Participants continued to use artificial tears 4 times daily during the treatment period.
883943|NCT01135498|B1|Baseline|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
884027|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
884028|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883944|NCT01135498|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2, tablet, orally (PO), every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
883945|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
883946|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
883947|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"ACycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
883948|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
883949|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
883950|NCT01135498|O1|Outcome|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab+Erlotinib|"Cycles 1-6 (3-week cycles): participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2, tablet, PO, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles.~Cycles 7 and beyond (3-week cycles): If all 6 cycles were tolerated with no disease progression, participants then received bevacizumab 7.5 mg/kg IV on Day 1 and erlotinib 150 mg tablets, PO, once daily. This cycle was repeated every 3 weeks until disease progression."
883951|NCT01135498|E1|Reported Event|Bevacizumab+Eloxatin+Capecitabine/Bevacizumab+Erlotinib|A cycle was defined as the following: participants received 7.5 mg/kg bevacizumab, IV on Day 1; 130 mg/m^2 eloxatin tablets, orally, on Days 1 through 14; and 1000 mg/m^2 capecitabine tablets, orally, every 12 hours on Days 1 through 14. The cycle was repeated every 21 days for a maximum of 6 cycles. If all 6 cycles were tolerated with no disease progression, participants then received 7.5 mg/kg bevacizumab, IV on Day 1 and 150 mg erlotinib tablets, orally, once daily. This cycle was repeated every 3 weeks until disease progression.
883952|NCT01135420|B3|Baseline|Total|Total of all reporting groups
883953|NCT01135420|B2|Baseline|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety"
883954|NCT01135420|B1|Baseline|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
883955|NCT01135420|P2|Participant Flow|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention incorporated motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition received an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention had a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition was to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
883956|NCT01135420|P1|Participant Flow|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial received usual care (i.e., the care they would have received in the absence of a study)."
892175|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
883957|NCT01135420|O2|Outcome|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
883958|NCT01135420|O1|Outcome|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
883959|NCT01135420|E2|Reported Event|Telephone Monitoring|"Patients in the TM condition received an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.~Telephone Monitoring (TM) with Motivational Interviewing: Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety."
883960|NCT01135420|E1|Reported Event|Usual Care|"Psychiatry inpatient usual care~Usual care: All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study)."
883961|NCT01135381|B5|Baseline|Total|Total of all reporting groups
883962|NCT01135381|B4|Baseline|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
883963|NCT01135381|B3|Baseline|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883964|NCT01135381|B2|Baseline|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
883965|NCT01135381|B1|Baseline|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883966|NCT01135381|P4|Participant Flow|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
883967|NCT01135381|P3|Participant Flow|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883968|NCT01135381|P2|Participant Flow|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
883969|NCT01135381|P1|Participant Flow|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883970|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
883971|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883972|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
883973|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883974|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
884029|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
884030|NCT01135368|O3|Outcome|Pathological|Participants with pathological color vision at Baseline.
883975|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883976|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
883977|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883978|NCT01135381|O4|Outcome|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
883979|NCT01135381|O3|Outcome|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883980|NCT01135381|O2|Outcome|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
883981|NCT01135381|O1|Outcome|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883982|NCT01135381|E4|Reported Event|COPD Patients, Usual Discharge Care|Patients with chronic obstructive pulmonary disease (COPD) who receive usual discharge care (no intervention).
883983|NCT01135381|E3|Reported Event|COPD Patients, IVR-Enhanced Care|"Patients with chronic obstructive pulmonary disease (COPD) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883984|NCT01135381|E2|Reported Event|CHF Patients, Usual Discharge Care|Patients with congestive heart failure (CHF) who receive usual discharge care (no intervention).
883985|NCT01135381|E1|Reported Event|CHF Patients, IVR-Enhanced Care|"Patients with congestive heart failure (CHF) who receive the interactive voice response (IVR) intervention.~IVR-Enhanced Care : Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified."
883986|NCT01135368|B1|Baseline|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
883987|NCT01135368|P1|Participant Flow|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
883988|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883989|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883990|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
883991|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883992|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883993|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
883994|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883995|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883996|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
883997|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
883998|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
883999|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
884000|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
884001|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
884002|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
884003|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
884004|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
884005|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
884006|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
884007|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
884008|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
884009|NCT01135368|O3|Outcome|Pathological|Participants with pathological assessment at Baseline.
884010|NCT01135368|O2|Outcome|Normal|Participants with normal assessment at Baseline.
884011|NCT01135368|O1|Outcome|No Data|Participants with no data at Baseline.
884031|NCT01135368|O2|Outcome|Normal|Participants with normal color vision at Baseline.
884032|NCT01135368|O1|Outcome|No Data|Participants with no color vision data at Baseline.
884033|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
884034|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
884035|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
884036|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
884037|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
884038|NCT01135368|O4|Outcome|Normal|Participants with adaptation classified as normal at Baseline.
884039|NCT01135368|O3|Outcome|Pathological|Participants with adaptation classified as pathological at Baseline.
884040|NCT01135368|O2|Outcome|Decreased Due to Age|Participants with adaptation decreased due to age at Baseline.
884041|NCT01135368|O1|Outcome|Missing Data|Participants with no data at Baseline.
884042|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
884043|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
884044|NCT01135368|O1|Outcome|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks. Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months.
884045|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
884046|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
884047|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
884048|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
884049|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
884050|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
884051|NCT01135368|O5|Outcome|No Data|Participants with no intestinal metaplasia data at Baseline.
884052|NCT01135368|O4|Outcome|Severe|Participants with severe intestinal metaplasia at Baseline.
884053|NCT01135368|O3|Outcome|Moderate|Participants with moderate intestinal metaplasia at Baseline.
884054|NCT01135368|O2|Outcome|Mild|Participants with mild intestinal metaplasia at Baseline.
884055|NCT01135368|O1|Outcome|None|Participants with no intestinal metaplasia at Baseline.
884056|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
884057|NCT01135368|O1|Outcome|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
884058|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
884059|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
884060|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
884061|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
884062|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
884063|NCT01135368|O5|Outcome|No Data|Participants with no data at Baseline.
884064|NCT01135368|O4|Outcome|Severe|Participants with severe atrophy at Baseline.
884065|NCT01135368|O3|Outcome|Moderate|Participants with moderate atrophy at Baseline.
884066|NCT01135368|O2|Outcome|Mild|Participants with mild atrophy at Baseline.
884067|NCT01135368|O1|Outcome|No Atrophy|Participants with no atrophy at Baseline.
884068|NCT01135368|O4|Outcome|No Data|Participants with no data at Baseline.
884069|NCT01135368|O3|Outcome|Linear|Participants with linear, chain producing hyperplasia at Baseline.
884070|NCT01135368|O2|Outcome|Simple|Participants with simple (diffuse) hyperplasia at Baseline.
884071|NCT01135368|O1|Outcome|Normal|Participants with normal ECL cell classification at Baseline.
884072|NCT01135368|O5|Outcome|Grade D|Participants with Grade D (mucosal breaks which involve at least 75% of the oesophageal circumference) at Baseline.
884073|NCT01135368|O4|Outcome|Grade C|Participants with Grade C (mucosal breaks that extend between the tops of two or more mucosal folds, but which involve less than 75% of the oesophageal circumference) at Baseline.
884074|NCT01135368|O3|Outcome|Grade B|Participants with Grade B (one or more mucosal breaks more than 5 mm long, none of which extends between the tops of two mucosal folds) at Baseline.
884075|NCT01135368|O2|Outcome|Grade A|Participants with Grade A (one or more mucosal breaks no longer than 5 mm, none of which extends between the tops of the mucosal folds) at Baseline.
884076|NCT01135368|O1|Outcome|Grade 0|Participants with Grade 0 (normal aspect of mucosa) at Baseline.
884077|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
884078|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
884079|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
884080|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
884081|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
884082|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
884083|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
884084|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
884085|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
884086|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
884087|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
884088|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
884089|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
884090|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
884091|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
884092|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
884093|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
884094|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
884095|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
884096|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
884097|NCT01135368|O4|Outcome|Severe|Participants with severe symptoms at Baseline.
884098|NCT01135368|O3|Outcome|Moderate|Participants with moderate symptoms at Baseline.
884099|NCT01135368|O2|Outcome|Mild|Participants with mild symptoms at Baseline.
884100|NCT01135368|O1|Outcome|None|Participants with no symptoms at Baseline.
884101|NCT01135368|E1|Reported Event|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.~Depending on response, dosage could then be decreased to 15 mg, once daily, or increased to 30 mg, twice daily for up to 4 years and 10 months."
884102|NCT01135186|B1|Baseline|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1 through week 4)~sapropterin dihydrochloride: sapropterin dihydrochloride: 20mg/kg/day (week 5 through week 8)"
884103|NCT01135186|P1|Participant Flow|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
884104|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day week 1-4, 20mg/kg/day week 5-8."
884105|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day weeks (1-4) and 20mg/kg/days weeks (week 5-8)"
884106|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day week 1-4, 20mg/kg/day week 5-8."
884107|NCT01135186|O1|Outcome|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day"
884108|NCT01135186|E1|Reported Event|Open Label Study|"sapropterin dihydrochloride~sapropterin dihydrochloride: sapropterin dihydrochloride: 10mg/kg/day (week 1-4) 20 mg/kg/day (week 5-8)"
884109|NCT01135134|B3|Baseline|Total|Total of all reporting groups
884110|NCT01135134|B2|Baseline|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
884111|NCT01135134|B1|Baseline|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
884112|NCT01135134|P2|Participant Flow|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
884113|NCT01135134|P1|Participant Flow|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
884114|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
884115|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
884116|NCT01135134|O2|Outcome|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
884117|NCT01135134|O1|Outcome|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
884118|NCT01135134|E2|Reported Event|Placebo|"Placebo MFNS. Administration was as follows:~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks."
884119|NCT01135134|E1|Reported Event|MFNS|"Mometasone furoate nasal spray (MFNS) 50 mcg nasal spray device. The dose was as follows:~5 to 11 years: one spray per nostril once daily (100 mcg/day as MF) in the morning for 2 weeks.~12 to 15 years: 2 sprays per nostril once daily (200 mcg/day as MF) in the morning for 2 weeks."
884120|NCT01135069|B4|Baseline|Total|Total of all reporting groups
884121|NCT01135069|B3|Baseline|Placebo|Microsphere Gel no active
884122|NCT01135069|B2|Baseline|Brand|Retin-A Micro 0.1%
884123|NCT01135069|B1|Baseline|Generic|Tretinoin Microsphere Gel 0.1%
884124|NCT01135069|P3|Participant Flow|Placebo|Microsphere Gel no active
884125|NCT01135069|P2|Participant Flow|Brand|Retin-A Micro 0.1%
884126|NCT01135069|P1|Participant Flow|Generic|Tretinoin Microsphere Gel 0.1%
884127|NCT01135069|O3|Outcome|Placebo|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 58% reduction"
884128|NCT01135069|O2|Outcome|Brand|"Treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 76% reduction"
884129|NCT01135069|O1|Outcome|Generic|"treatment of acne for 12 weeks~Percent change (reduction) in acne lesions was 74% reduction."
884130|NCT01135069|E3|Reported Event|Placebo|Microsphere Gel no active
884131|NCT01135069|E2|Reported Event|Brand|Retin-A Micro 0.1%
884132|NCT01135069|E1|Reported Event|Generic|Tretinoin Microsphere Gel 0.1%
884134|NCT01135017|B2|Baseline|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884135|NCT01135017|B1|Baseline|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884136|NCT01135017|P2|Participant Flow|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884137|NCT01135017|P1|Participant Flow|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884138|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884139|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884140|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884141|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884142|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884143|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884144|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884145|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884146|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884147|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884148|NCT01135017|O2|Outcome|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884149|NCT01135017|O1|Outcome|Placebo|Placebo (for Dronedarone) twice a day for 12 weeks
884150|NCT01135017|E2|Reported Event|Dronedarone|Dronedarone 400 mg twice a day for 12 weeks
884151|NCT01135017|E1|Reported Event|Placebo|Placebo (for dronedarone) twice a day for 12 weeks
884152|NCT01134952|B1|Baseline|MMF MRL Switch|Liver transplant recipients with Hepatitis C virus switched from mycophenolate mofetil (MMF) to sirolimus (SRL) for 3 months and then switched back to MMF
884153|NCT01134952|P1|Participant Flow|MMF SRL Switch|Liver transplant recipients with Hepatitis C virus taking sirolimus (SRL) instead of mycophenolate mofetil (MMF) for 3 months
884154|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
884155|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
884156|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
884157|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
884158|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
884159|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
884160|NCT01134952|O1|Outcome|MMF SRL Switch|All patients 3 months after switch from mycophenolate to sirolimus
884161|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients switched from mycophenolate mofetil to sirolimus
884162|NCT01134952|O1|Outcome|MMF SRL Switch|All patients after switch from mycophenolate to sirolimus
884163|NCT01134952|O1|Outcome|MMF SRL Switch|All patients switched for 3 months from mycophenolate mofetil to sirolimus and then back to mycophenolate mofetil
884164|NCT01134952|O1|Outcome|MMF SRL Switch|Liver transplant recipients with HCV 3 months after switch from mycophenolate to sirolimus
884165|NCT01134952|E1|Reported Event|MMF SRL Switch|All patients during 3 month period of switch from mycophenolate mofetil (MMF) to sirolimus and for 3 months after switch back to MMF
884166|NCT01134939|B9|Baseline|Total|Total of all reporting groups
884167|NCT01134939|B8|Baseline|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884168|NCT01134939|B7|Baseline|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884169|NCT01134939|B6|Baseline|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884170|NCT01134939|B5|Baseline|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884171|NCT01134939|B4|Baseline|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884172|NCT01134939|B3|Baseline|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884173|NCT01134939|B2|Baseline|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884174|NCT01134939|B1|Baseline|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884175|NCT01134939|P8|Participant Flow|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884176|NCT01134939|P7|Participant Flow|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884177|NCT01134939|P6|Participant Flow|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884178|NCT01134939|P5|Participant Flow|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884179|NCT01134939|P4|Participant Flow|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884180|NCT01134939|P3|Participant Flow|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884181|NCT01134939|P2|Participant Flow|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884182|NCT01134939|P1|Participant Flow|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884650|NCT01134016|O1|Outcome|Cmax Day 28|the observed maximum plasma concentration after dosing on Day 28
884183|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884184|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884185|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884186|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884187|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884188|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884189|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884190|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884191|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884192|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884193|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884194|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884195|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884196|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884197|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884198|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884199|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884200|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884201|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884202|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884203|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884204|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884205|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884206|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884207|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884208|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884209|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884210|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884211|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884212|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884213|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884214|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884215|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884216|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884217|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884218|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884219|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884651|NCT01134016|O1|Outcome|Cmax Day 1|the observed maximum plasma concentration after dosing on Day 1
884220|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884221|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884222|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884223|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884224|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884225|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884226|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884227|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884228|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884229|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884230|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884231|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884232|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884233|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884234|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884235|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884236|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884237|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884238|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884239|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884240|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884241|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884242|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884243|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884244|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884245|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884246|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884247|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884248|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884249|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884250|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884251|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884252|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884253|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884254|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884255|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884256|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884257|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884258|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884259|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884260|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884261|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884262|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884263|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884264|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884265|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884266|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884267|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884268|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884269|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884270|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884271|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884272|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884273|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884274|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884275|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884276|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884277|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884278|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884279|NCT01134939|O8|Outcome|Male Patients, Baseline Viral Load Not Documented|Male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884280|NCT01134939|O7|Outcome|Female Patients, Baseline Viral Load Not Documented|Female patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884281|NCT01134939|O6|Outcome|Pretreated Male Patients, Baseline Viral Load > 50 Copies/mL|Male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884282|NCT01134939|O5|Outcome|Pretreated Female Patients, Baseline Viral Load > 50 Copies/mL|Female patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884283|NCT01134939|O4|Outcome|Pretreated Male Patients, Baseline Viral Load ≤ 50 Copies/mL|Male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884284|NCT01134939|O3|Outcome|Pretreated Female Patients, Baseline Viral Load ≤ 50 Copies/mL|Female patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884285|NCT01134939|O2|Outcome|Treatment-naive Male Patients|Male patients who were not pretreated with HIV therapy.
884286|NCT01134939|O1|Outcome|Treatment-naive Female Patients|Female patients who were not pretreated with HIV therapy.
884287|NCT01134939|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Female and male patients who could not be assigned to one of the three subgroups and had no documented viral load value.
884288|NCT01134939|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Female and male patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
884289|NCT01134939|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Female and male patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
884290|NCT01134939|E1|Reported Event|Treatment-naive Patients|Female and male patients who were not pretreated with HIV therapy.
884291|NCT01134900|B3|Baseline|Total|Total of all reporting groups
884292|NCT01134900|B2|Baseline|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
884293|NCT01134900|B1|Baseline|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
884294|NCT01134900|P2|Participant Flow|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
884295|NCT01134900|P1|Participant Flow|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
885834|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
884296|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
884297|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
884298|NCT01134900|O2|Outcome|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
884299|NCT01134900|O1|Outcome|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
884300|NCT01134900|E2|Reported Event|Control|Patients do not appear on dashboard for pharmacy intervention, but only receive existing clinical decision support interventions.
884301|NCT01134900|E1|Reported Event|Dashboard|Patients appear on dashboard and are eligible for pharmacy intervention in addition to existing clinical decision support interventions.
884302|NCT01134887|B5|Baseline|Total|Total of all reporting groups
884303|NCT01134887|B4|Baseline|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
884304|NCT01134887|B3|Baseline|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
884305|NCT01134887|B2|Baseline|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
884306|NCT01134887|B1|Baseline|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
884307|NCT01134887|P4|Participant Flow|Arm 4: Control-Physician|"Primary care providers randomly assigned to the Control-Physicians arm of the study did not receive coaching or additional resources, and conducted their primary care practice as usual."
884308|NCT01134887|P3|Participant Flow|Arm 3: Intervention-Physician|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication. Second, physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this meeting was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management."
884309|NCT01134887|P2|Participant Flow|Arm 2: Control-Veteran|"Veterans enrolled in the Control-Veterans arm received a copy of the NIA guide for Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
884310|NCT01134887|P1|Participant Flow|Arm 1: Intervention-Veteran|"Veterans enrolled in the Intervention-Veterans arm received a copy of the NIA guide for Talking with Your Doctor. Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management."
884311|NCT01134887|O2|Outcome|Arm 2: Control-Veterans|The attention control comparator consisted of giving Veterans a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
884312|NCT01134887|O1|Outcome|Arm 1: Intervention-Veterans|Veterans randomized to the intervention group received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit, an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the Veteran in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
884313|NCT01134887|E4|Reported Event|Arm 4: Control-Physicians|Control physicians were told to conduct their encounters as usual and were not given any coaching. Adverse event reporting was provided as part of the study.
884314|NCT01134887|E3|Reported Event|Arm 3: Intervention-Physicians|The 5 intervention arm physicians were coached in the Four Habits of Highly Effective Clinicians in a one hour face to face meeting involving review of the provider's interaction with his or her intervention patients and suggestions for improvement based on these observations.
884315|NCT01134887|E2|Reported Event|Arm 2: Attention Control|Veterans enrolled in the attention control arm received a copy of the NIA guide for “Talking with Your Doctor.” This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level.
884316|NCT01134887|E1|Reported Event|Arm 1: Intervention|Veterans enrolled in the intervention arm received a copy of the NIA guide for “Talking with Your Doctor.” Just prior to their next scheduled visit an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor. Additional information was provided on how to be an active participant in the health care encounter and how to communicate effectively to promote productive self-management. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
884317|NCT01134783|B3|Baseline|Total|Total of all reporting groups
884318|NCT01134783|B2|Baseline|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
884319|NCT01134783|B1|Baseline|Control Group|This control group arm consists of students who served as the comparison group.
884320|NCT01134783|P2|Participant Flow|Control Group|217 participants were randomized to the control condition
884321|NCT01134783|P1|Participant Flow|Intervention Group|224 participants were randomized to the intervention condition
884322|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
884323|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
884324|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
884325|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
884326|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
884327|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
884328|NCT01134783|O2|Outcome|Control Group|Control group (serving as a comparison group)
884329|NCT01134783|O1|Outcome|Intervention Group|"The CHOICES intervention included a 1-credit, academic college course focusing on healthy weight behaviors and participation in a social networking and social support website~CHOICES Intervention: Academic course on healthy weight behaviors followed by participation in a social networking and social support website."
884330|NCT01134783|O2|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
884331|NCT01134783|O1|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
884332|NCT01134783|O2|Outcome|Intervention Group|This intervention arm is a combination of the face-to-face class students, hybrid class students and online class students
884333|NCT01134783|O1|Outcome|Control Group|This control group arm consists of students who served as the comparison group.
884334|NCT01134783|E2|Reported Event|Control Group|This control group consists of students who served as the comparison group.
884335|NCT01134783|E1|Reported Event|Intervention Group|This intervention group is a combination of the face-to-face class students, hybrid class students and online class students.
884336|NCT01134731|B4|Baseline|Total|Total of all reporting groups
884337|NCT01134731|B3|Baseline|Placebo 1-5 Capsules|12 weeks
884338|NCT01134731|B2|Baseline|Lithium 600-1500mg|daily
884339|NCT01134731|B1|Baseline|Paliperidone 1-5mg|daily
884340|NCT01134731|P3|Participant Flow|Placebo|1-5 capsules
884341|NCT01134731|P2|Participant Flow|Lithium|"mood stabilizer~dose escalation levels 1-5 daily dosing lithium: 300-1500mg daily (QD)"
884342|NCT01134731|P1|Participant Flow|Paliperidone|dose escalation, levels 1-5 daily dosing range from 1-5 mg
884343|NCT01134731|O3|Outcome|Placebo|1-5 placebo capsules
884344|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg~lithium: 300-1500mg QD"
884345|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg~paliperidone: 1-5 mg qd"
884346|NCT01134731|O3|Outcome|Placebo|placebo comparator, 1-5 capsules
884347|NCT01134731|O2|Outcome|Lithium|"dose escalation, level 1-5 daily dosing 300-1500mg~lithium: 300-1500mg QD"
884348|NCT01134731|O1|Outcome|Paliperidone|"dose escalation , levels 1-5 daily dosing ranged from 1-5mg~paliperidone: 1-5 mg qd"
884349|NCT01134731|E3|Reported Event|Placebo|
884350|NCT01134731|E2|Reported Event|Lithium|
884351|NCT01134731|E1|Reported Event|Paliperidone|
884352|NCT01134705|B3|Baseline|Total|Total of all reporting groups
884353|NCT01134705|B2|Baseline|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
884354|NCT01134705|B1|Baseline|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
884355|NCT01134705|P2|Participant Flow|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
884356|NCT01134705|P1|Participant Flow|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily.
884357|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
884358|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
884359|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
884360|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
884361|NCT01134705|O2|Outcome|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
884362|NCT01134705|O1|Outcome|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
884363|NCT01134705|E2|Reported Event|Placebo|During the 6-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
884364|NCT01134705|E1|Reported Event|BDP HFA 320 µg/Day|During the 6-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
884365|NCT01134627|B3|Baseline|Total|Total of all reporting groups
884366|NCT01134627|B2|Baseline|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884367|NCT01134627|B1|Baseline|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884368|NCT01134627|P2|Participant Flow|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884369|NCT01134627|P1|Participant Flow|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884370|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884371|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884372|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884373|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884374|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884375|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884376|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884377|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884378|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884379|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884380|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884381|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884382|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884383|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884384|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884385|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884386|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884387|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
885835|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
884388|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884389|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884390|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884391|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884392|NCT01134627|O2|Outcome|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884393|NCT01134627|O1|Outcome|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884394|NCT01134627|E2|Reported Event|Rebif® + Placebo|Participants who self-administered Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly also received placebo tablets twice daily for 96 weeks.
884395|NCT01134627|E1|Reported Event|Rebif®+ Minocycline|Participants who self-administered Rebif® (interferon beta-1 alpha [IFN beta-1a]) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly also received minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
884435|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884436|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884437|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884438|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884409|NCT01134549|B6|Baseline|Total|Total of all reporting groups
884410|NCT01134549|B5|Baseline|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884411|NCT01134549|B4|Baseline|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884412|NCT01134549|B3|Baseline|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884413|NCT01134549|B2|Baseline|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884414|NCT01134549|B1|Baseline|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884415|NCT01134549|P5|Participant Flow|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884416|NCT01134549|P4|Participant Flow|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884417|NCT01134549|P3|Participant Flow|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884418|NCT01134549|P2|Participant Flow|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884419|NCT01134549|P1|Participant Flow|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884420|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884421|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884422|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884423|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884424|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884425|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884426|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884427|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884428|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884429|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884430|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884431|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884432|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884433|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884434|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884439|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884440|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884441|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884442|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884443|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884444|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884445|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884446|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884447|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884448|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884449|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884450|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884451|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884452|NCT01134549|O4|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884453|NCT01134549|O3|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884454|NCT01134549|O2|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884455|NCT01134549|O1|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884456|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884457|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884458|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884459|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884460|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884461|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884462|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884463|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884464|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884465|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884466|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884467|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884468|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884469|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884470|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884471|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884472|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884473|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884474|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884475|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884476|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884477|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884478|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884479|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884480|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884481|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884482|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884483|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884484|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884485|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884486|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884487|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884488|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884489|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884490|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884491|NCT01134549|O5|Outcome|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884492|NCT01134549|O4|Outcome|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884493|NCT01134549|O3|Outcome|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884494|NCT01134549|O2|Outcome|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884495|NCT01134549|O1|Outcome|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884496|NCT01134549|E6|Reported Event|Etelcalcetide Pooled|Participants received a single dose of etelcalcetide administered by intravenous injection.
884497|NCT01134549|E5|Reported Event|Etelcalcetide 10 mg|Participants received a single dose of 10 mg etelcalcetide administered by intravenous injection.
884498|NCT01134549|E4|Reported Event|Etelcalcetide 5 mg|Participants received a single dose of 5 mg etelcalcetide administered by intravenous injection.
884499|NCT01134549|E3|Reported Event|Etelcalcetide 2 mg|Participants received a single dose of 2 mg etelcalcetide administered by intravenous injection.
884500|NCT01134549|E2|Reported Event|Etelcalcetide 0.5 mg|Participants received a single dose of 0.5 mg etelcalcetide administered by intravenous injection.
884501|NCT01134549|E1|Reported Event|Pooled Placebo|Participants received a single dose of placebo administered by intravenous injection.
884502|NCT01134510|B3|Baseline|Total|Total of all reporting groups
884503|NCT01134510|B2|Baseline|Placebo|Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. Then PI will describe the standard of care of Transplant Immunology Program (TIP) patients. After that PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be either emailed or faxed to the patient for review and consideration of study participation. The patient can contact the study team where they will have the opportunity to ask questions and then sign the Informed Consent Form (ICF), if interested.
884504|NCT01134510|B1|Baseline|C1 Esterase Inhibitor|"Potential subjects will be identified after a review of medical records of patients under the care of one or more of the study investigators. Potential subjects will be identified and approached during an inpatient or outpatient clinical visit by a member of the research team. The Principal investigator (PI) I will explain what it means to be highly-sensitized and the risks associated with it. The PI will describe the study and explain the risks and benefits of participation. After the discussion, a copy of the consent form will be emailed or faxed to the patient for review & consideration of study participation. The patient can contact the study team to ask questions and sign the Informed Consent Form (ICF), if interested.~C1 INH is dosed at 20 units per kg body weight and is administered by slow IV injection at a rate of approximately 4 mL per minute. Study patients will receive 20U/kg C1 INH vs placebo (0.9% NS) on days 0 and day 2, then twice weekly X 3 weeks."
884505|NCT01134510|P2|Participant Flow|Placebo|Patients will receive placebo (0.9% Normal Saline) on days 0 and day 2, then twice weekly for 3 weeks.
884506|NCT01134510|P1|Participant Flow|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, Complement 3 and Complement 4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% Normal Saline) on day 0 and day 2, then twice weekly X 3 weeks. A protocol biopsy will be performed at 6 month to assess the allograft for evidence of Antibody Mediated Rejection, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and Anibody Mediated Rejection episodes as well as Donor Specific Antibody. A protocol biopsy will be performed at 6 month.
884507|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
884508|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 Units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
884509|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
884510|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
884511|NCT01134510|O2|Outcome|Placebo|Patients will receive placebo (0.9% NS) on days 0 and day 2, then twice weekly X3 weeks.
884551|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
892176|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
884552|NCT01134315|E2|Reported Event|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884553|NCT01134315|E1|Reported Event|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884512|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|Patients receiving transplants will have pre-transplant labs for C1 INH levels, C3 and C4 obtained. In addition to the standard post-transplant immunosuppressive protocol, participating patients will receive 20 units/kg C1 INH vs placebo (0.9% NS) on day 0 and day 2, then twice weekly X 3 weeks (see Appendix A). A protocol biopsy will be performed at 6M to assess the allograft for evidence of AMR, including C4d staining using Banff 2009 criteria. After completion of the C1 INH therapy, patients will be followed up to 6M to assess allograft function and AMR episodes as well as DSA. A protocol biopsy will be performed at 6M.
884513|NCT01134510|O2|Outcome|Normal Saline|"10 subjects placebo in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
884514|NCT01134510|O1|Outcome|C1 Esterase Inhibitor|"10 subjects will receive C1 esterase inhibitor in addition to standard of care immunosuppressive therapy.~C1 Esterase Inhibitor: C1 Esterase Inhibitor 20 units/kg vs Placebo twice weekly x 4 weeks"
884515|NCT01134510|E2|Reported Event|C1 Esterase Inhibitor|Total of 1 Serious Adverse Event (1/10 = 10%)
884516|NCT01134510|E1|Reported Event|Placebo|Total of 2 Serious Adverse Events (2/10 patients = 20%)
884517|NCT01134393|B1|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884518|NCT01134393|P1|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884519|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884520|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884521|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884522|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884523|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884524|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884525|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884526|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884527|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884528|NCT01134393|O1|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884529|NCT01134393|E2|Reported Event|T80/A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily
884530|NCT01134393|E1|Reported Event|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
884531|NCT01134315|B3|Baseline|Total|Total of all reporting groups
884532|NCT01134315|B2|Baseline|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884533|NCT01134315|B1|Baseline|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884534|NCT01134315|P2|Participant Flow|Calcitriol|Pediatric participants who received calcitriol to treat secondary hyperparathyroidism (SHPT). Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884535|NCT01134315|P1|Participant Flow|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat secondary hyperparathyroidism (SHPT). Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884536|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884537|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884538|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884539|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884540|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884541|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884542|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884543|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884544|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884545|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884546|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884547|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884548|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
884549|NCT01134315|O1|Outcome|Paricalcitol|Pediatric participants who received paricalcitol capsules to treat SHPT. Paricalcitol was prescribed by each physician under the usual and customary practice of that physician.
884550|NCT01134315|O2|Outcome|Calcitriol|Pediatric participants who received calcitriol to treat SHPT. Calcitriol was prescribed by each physician under the usual and customary practice of that physician.
892177|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
884555|NCT01134276|B2|Baseline|PTBD|final biliary drainage procedure : biliary drainage via PTBD
884556|NCT01134276|B1|Baseline|ERBD|final biliary drainage procedure: biliary drainage via ERBD/ENBD
884557|NCT01134276|P2|Participant Flow|PTBD|biliary drainage : biliary drainage via PTBD
884558|NCT01134276|P1|Participant Flow|ERBD|biliary drainage : biliary drainage via ERBD/ENBD
884559|NCT01134276|O2|Outcome|ERBD|Final biliary drainage procedure: biliary drainage via ERBD/ENBD
884560|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
884561|NCT01134276|O2|Outcome|ENBD/ERBD|Final biliary drainage procedure: biliary drainage via ENBD/ERBD
884562|NCT01134276|O1|Outcome|PTBD|Final biliary drainage procedure: biliary drainage via PTBD
884563|NCT01134276|O2|Outcome|ERBD|finial biliary drainage procedure: biliary drainage via ERBD or ENBD
884564|NCT01134276|O1|Outcome|PTBD|finial biliary drainage procedure: biliary drainage via PTBD
884565|NCT01134276|E2|Reported Event|ERBD|"final biliary drainage procedure: biliary drainage via ERBD/ENBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
884566|NCT01134276|E1|Reported Event|PTBD|"final biliary drainage procedure: biliary drainage via PTBD~Adverse event will be monitored by examination of clinic doctor in both in-patient and out-patient setting"
884567|NCT01134107|B3|Baseline|Total|Total of all reporting groups
884568|NCT01134107|B2|Baseline|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
884569|NCT01134107|B1|Baseline|Lispro 6D/Aspart 6D|Insulin Lispro 6D administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
884570|NCT01134107|P2|Participant Flow|Aspart 6D/Lispro 6D|Insulin Aspart 6D administered by infusion pump for 12 weeks, followed by Insulin Lispro 6D administered by infusion pump for 12 weeks.
884571|NCT01134107|P1|Participant Flow|Lispro 6D/Aspart 6D|Insulin Lispro 6 Day (6D) administered by infusion pump for 12 weeks, followed by Insulin Aspart 6D administered by infusion pump for 12 weeks.
884572|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884573|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884574|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884575|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884576|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884577|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884578|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884579|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884580|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884581|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884582|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884583|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884584|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884585|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884586|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884587|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884588|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884589|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884590|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884591|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884592|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884593|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884594|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884595|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884596|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884597|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884598|NCT01134107|O2|Outcome|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884599|NCT01134107|O1|Outcome|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884600|NCT01134107|E2|Reported Event|Insulin Aspart 6D|Insulin Aspart 6D administered by infusion pump for 12 week treatment period
884601|NCT01134107|E1|Reported Event|Insulin Lispro 6D|Insulin Lispro 6D administered by infusion pump for 12 week treatment period
884602|NCT01134042|B4|Baseline|Total|Total of all reporting groups
884603|NCT01134042|B3|Baseline|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884654|NCT01134016|O10|Outcome|Half-life Time Day 28: 300 mg|The time of plasma concentration drops from maximum to half
890160|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
884604|NCT01134042|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884605|NCT01134042|B1|Baseline|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884606|NCT01134042|P3|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884607|NCT01134042|P2|Participant Flow|FF/VI 200/25 µg OD|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884608|NCT01134042|P1|Participant Flow|FF 200 µg OD|Participants received FF 200 microgram (µg) inhalation powder via a Dry Powder Inhaler (DPI) once daily (OD) in the evening plus placebo via the DISKUS/ACCUHALER twice daily (BID), for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884609|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884610|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884611|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884612|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884613|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884614|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884615|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884616|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884617|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884618|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884619|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884620|NCT01134042|O1|Outcome|FF 200 µg OD Arm|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884621|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884622|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884623|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884624|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884649|NCT01134016|O1|Outcome|AUC0-t on Day 1|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 1
884625|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884626|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884627|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884628|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884629|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884630|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884631|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884632|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884633|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884634|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884635|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884636|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884637|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884638|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884639|NCT01134042|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884640|NCT01134042|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884641|NCT01134042|O1|Outcome|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884642|NCT01134042|E3|Reported Event|FP 500 µg BID|Participants received FP 500 µg inhalation powder via the DISKUS/ACCUHALER BID plus placebo via a DPI OD in the evening, for 24 weeks. Additionally participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884643|NCT01134042|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder via a DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884644|NCT01134042|E1|Reported Event|FF 200 µg OD|Participants received FF 200 µg inhalation powder via a Dry Powder Inhaler DPI OD in the evening plus placebo via the DISKUS/ACCUHALER BID, for 24 weeks. Additionally participants were provided with albuterol/salbutamol inhalation aerosol to be used as rescue medication as needed.
884645|NCT01134016|B1|Baseline|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
884646|NCT01134016|P1|Participant Flow|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
884647|NCT01134016|O1|Outcome|Tumer Responce at Per-protocol (PP) Population|All patients who completed at least 3 cycles of treatment with proper imaging assessment (RECIST) of tumor size.
884648|NCT01134016|O1|Outcome|AUC0-t on Day 28|truncated area under the plasma concentration-time curve from the beginning of dosing to the last measurable concentration on Day 28
884652|NCT01134016|O12|Outcome|Half-life Time Day 28: 600mg|The time of plasma concentration drops from maximum to half
884653|NCT01134016|O11|Outcome|Half-life Time Day 28: 450 mg|The time of plasma concentration drops from maximum to half
884655|NCT01134016|O9|Outcome|Half-life Time Day 28: 200 mg|The time of plasma concentration drops from maximum to half
884656|NCT01134016|O8|Outcome|Half-life Time Day 28:100 mg|The time of plasma concentration drops from maximum to half
884657|NCT01134016|O7|Outcome|Half-life Time Day 28: 50mg|The time of plasma concentration drops from maximum to half
884658|NCT01134016|O6|Outcome|Half-life Time Day 1: 600 mg|The time of plasma concentration drops from maximum to half
884659|NCT01134016|O5|Outcome|Half-life Time Day 1: 450 mg|The time of plasma concentration drops from maximum to half
884660|NCT01134016|O4|Outcome|Half-life Time Day 1: 300mg|The time of plasma concentration drops from maximum to half
884661|NCT01134016|O3|Outcome|Half-life Time Day 1: 200mg|The time of plasma concentration drops from maximum to half
884662|NCT01134016|O2|Outcome|Half-life Time Day 1: 100 mg|The time of plasma concentration drops from maximum to half
884663|NCT01134016|O1|Outcome|Half-life Time Day 1:50mg|The time of plasma concentration drops from maximum to half
884664|NCT01134016|O12|Outcome|Tmax Day 28: 600mg|Patient represent the time to reach the maximum plasma concentration after dose
884665|NCT01134016|O11|Outcome|Tmax Day 28: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
884666|NCT01134016|O10|Outcome|Tmax Day 28: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
884667|NCT01134016|O9|Outcome|Tmax Day 28: 200 mg|Patient represent the time to reach the maximum plasma concentration after dose
884668|NCT01134016|O8|Outcome|Tmax Day 28: 100mg|Patient represent the time to reach the maximum plasma concentration after dose
884669|NCT01134016|O7|Outcome|Tmax Day 28: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
884670|NCT01134016|O6|Outcome|Tmax Day 1 :600 mg|Patient represent the time to reach the maximum plasma concentration after dose
884671|NCT01134016|O5|Outcome|Tmax Day 1: 450mg|Patient represent the time to reach the maximum plasma concentration after dose
884672|NCT01134016|O4|Outcome|Tmax Day 1: 300mg|Patient represent the time to reach the maximum plasma concentration after dose
884673|NCT01134016|O3|Outcome|Tmax Day 1: 200mg|Patient represent the time to reach the maximum plasma concentration after dose
884674|NCT01134016|O2|Outcome|Tmax Day 1: 100 mg|Patient represent the time to reach the maximum plasma concentration after dose
884675|NCT01134016|O1|Outcome|Tmax Day1: 50mg|Patient represent the time to reach the maximum plasma concentration after dose
884676|NCT01134016|O1|Outcome|Antroquinonol|Maximum Tolerable Dose for Antroquinonol
884677|NCT01134016|E1|Reported Event|Antroquinonol|"Safety dose finding from 50mg to 600mg~Antroquinonol : Dosage form: 50 mg and 100 mg capsules~Dosage levels: 50 mg, 100 mg, 200 mg, 300mg, 450mg and 600mg ( 6 cohorts)~Frequency: take daily for 4 weeks per subject per dosage level"
884678|NCT01133977|B6|Baseline|Total|Total of all reporting groups
884679|NCT01133977|B5|Baseline|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884680|NCT01133977|B4|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884681|NCT01133977|B3|Baseline|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884682|NCT01133977|B2|Baseline|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884683|NCT01133977|B1|Baseline|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884684|NCT01133977|P5|Participant Flow|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884685|NCT01133977|P4|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884686|NCT01133977|P3|Participant Flow|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884687|NCT01133977|P2|Participant Flow|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884688|NCT01133977|P1|Participant Flow|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884689|NCT01133977|O2|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884981|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884690|NCT01133977|O1|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
890161|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
884691|NCT01133977|O5|Outcome|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884692|NCT01133977|O4|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884693|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884694|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884695|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884696|NCT01133977|O3|Outcome|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884697|NCT01133977|O2|Outcome|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884698|NCT01133977|O1|Outcome|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit.
884699|NCT01133977|E5|Reported Event|Dacarbazine (Phase 2)|Participants received dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884700|NCT01133977|E4|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 2)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884701|NCT01133977|E3|Reported Event|22 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 22 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884702|NCT01133977|E2|Reported Event|20 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 20 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884703|NCT01133977|E1|Reported Event|16 mg Lenvatinib + Dacarbazine (Phase 1b)|Participants received 16 mg lenvatinib once daily continuously over 3 weeks (21 days) during each cycle in combination with dacarbazine (1000 mg/m2) on Day 1 of each 21-day cycle upto eight 21-day cycles (24 weeks) or more if participants experience clinical benefit
884704|NCT01133860|B1|Baseline|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
884705|NCT01133860|P1|Participant Flow|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
884706|NCT01133860|O1|Outcome|Eltrombopag|In patients with more than 100 x10e9 platelets/L at the end of therapy, we evaluated also the in vitro platelet aggregation after stimulation with adenosine diphosphate (5 and 20 mcM), collagen (5 and 20 mg/mL) and ristocetin (3 mg/mL) by the densitometric method of Born in native platelet rich plasma. The extent of platelet aggregation was measured 5 minutes after the addition of stimulating agents and results obtained in patients were compared with the normal ranges in the laboratories where the assay was performed. Results are reported as the number of patients with normal platelet aggregation.
884707|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
884708|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
884709|NCT01133860|O1|Outcome|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
884982|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884776|NCT01133704|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
890162|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
884710|NCT01133860|E1|Reported Event|Eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 continued eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 received eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 stopped therapy.
884711|NCT01133847|B4|Baseline|Total|Total of all reporting groups
884712|NCT01133847|B3|Baseline|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884713|NCT01133847|B2|Baseline|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884714|NCT01133847|B1|Baseline|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884715|NCT01133847|P3|Participant Flow|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884716|NCT01133847|P2|Participant Flow|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884717|NCT01133847|P1|Participant Flow|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884718|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884719|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884720|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884721|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884722|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884723|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884724|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884861|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884725|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884726|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884727|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884728|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884729|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884730|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884731|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884732|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884733|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884734|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884735|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884736|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|"All interventions described in Reading Instruction and ADHD treatment arms:~All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training."
884737|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884775|NCT01133704|B1|Baseline|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
884978|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884738|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884739|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884740|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884741|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884742|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884743|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884744|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884745|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884746|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884747|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884748|NCT01133847|O3|Outcome|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884749|NCT01133847|O2|Outcome|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884750|NCT01133847|O1|Outcome|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884751|NCT01133847|E3|Reported Event|Combined ADHD Treatment and Reading Instruction|All interventions described in Reading Instruction and ADHD treatment arms: Phonologically-based reading instruction provided for 45 minutes, four days per week, for 16 school weeks provided concurrently with carefully-managed medication (methylphenidate, mixed salt amphetamine, atomoxetine or guanfacine) and behavioral parent training.
884860|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
884752|NCT01133847|E2|Reported Event|Intensive Reading Instruction|Specialized phonologically-based reading instruction provided by well-trained tutors either individually (one-on-one) or to groups of two students for 45 minutes, four days per week, for 16 school weeks. Instruction was explicit and systematic, with extended opportunities to practice and apply skills in connected text with feedback. Interventionists used an individualized combination of published and unpublished programs targeting word reading and decoding, reading fluency, and reading comprehension, depending on students' needs documented in ongoing assessment.
884753|NCT01133847|E1|Reported Event|ADHD Treatment|Carefully-managed medication and behavioral parent training. Children began with a trial of extended release methylphenidate; if there was no benefit or the side effects were intolerable, this was followed by a trial of mixed salt amphetamine. if side effects of stimulants were intolerable, atomoxetine or guanfacine could be prescribed. Parent training was nine sessions provided by a psychologist addressing ADHD and its treatment, principles of behavior modification, and evidence-supported practices for managing behavior.
884754|NCT01133756|B4|Baseline|Total|Total of all reporting groups
884755|NCT01133756|B3|Baseline|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884756|NCT01133756|B2|Baseline|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884757|NCT01133756|B1|Baseline|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884758|NCT01133756|P3|Participant Flow|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884759|NCT01133756|P2|Participant Flow|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884760|NCT01133756|P1|Participant Flow|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (area under the concentration-time curve [AUC] 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884761|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884762|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884763|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884764|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884765|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884766|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884767|NCT01133756|O3|Outcome|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884768|NCT01133756|O2|Outcome|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884769|NCT01133756|O1|Outcome|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884770|NCT01133756|E3|Reported Event|Lenvatinib 8 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) intravenous (IV) infusion over 30 minutes in combination with lenvatinib 8 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884771|NCT01133756|E2|Reported Event|Lenvatinib 16 mg (Day 2 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 2 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884772|NCT01133756|E1|Reported Event|Lenvatinib 16 mg (Day 1 to Day 21) + Carboplatin + Gemcitabine|Participants received carboplatin (AUC 4) + gemcitabine (1000 mg/m2) IV infusion over 30 minutes in combination with lenvatinib 16 mg on Day 1 of 21-day cycle and gemcitabine (1000 mg/m2) alone on Day 8 of the cycle.
884773|NCT01133704|B3|Baseline|Total|Total of all reporting groups
884774|NCT01133704|B2|Baseline|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
885836|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
884777|NCT01133704|P1|Participant Flow|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
884778|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
884779|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
884780|NCT01133704|O2|Outcome|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
884781|NCT01133704|O1|Outcome|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
884782|NCT01133704|E2|Reported Event|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
884783|NCT01133704|E1|Reported Event|Sipuleucel-T (APC8015)|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
884784|NCT01133665|B1|Baseline|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884785|NCT01133665|P1|Participant Flow|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884786|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884787|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884788|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884789|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884790|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884791|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884792|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884793|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884794|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884795|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884796|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884797|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884798|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884799|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884800|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884801|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884802|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884803|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884804|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884805|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884806|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884807|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884808|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884809|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884810|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884811|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884812|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884813|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884814|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884815|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884816|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884817|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884818|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884819|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884820|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884821|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884822|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884823|NCT01133665|O1|Outcome|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884824|NCT01133665|E1|Reported Event|Cetuximab and Lenalidomide|Patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) were treated wıth cetuximab (500 mg/m2 IV every 2 weeks) and lenalidomide (25 mg orally or via feeding tube once daily)
884825|NCT01133626|B4|Baseline|Total|Total of all reporting groups
884826|NCT01133626|B3|Baseline|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
884827|NCT01133626|B2|Baseline|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
884828|NCT01133626|B1|Baseline|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
885837|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
884829|NCT01133626|P3|Participant Flow|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
884830|NCT01133626|P2|Participant Flow|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
884831|NCT01133626|P1|Participant Flow|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
884832|NCT01133626|O3|Outcome|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
884833|NCT01133626|O2|Outcome|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
884834|NCT01133626|O1|Outcome|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
884835|NCT01133626|E3|Reported Event|Placebo/Prednisone|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a 10/mg a day prednisone capsule.
884836|NCT01133626|E2|Reported Event|Placebo|Participants self-administered 4 actuations (two per nostril) of placebo HFA once daily each morning for 6 weeks (42 days) as double-blind therapy for BDP. During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
884837|NCT01133626|E1|Reported Event|BDP HFA 320 µg/Day|Participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning for 6 weeks (42 days). During week 6 (days 36-42), participants also took a placebo capsule as double-blind therapy for prednisone.
884838|NCT01133522|B11|Baseline|Total|Total of all reporting groups
884839|NCT01133522|B10|Baseline|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884840|NCT01133522|B9|Baseline|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
884841|NCT01133522|B8|Baseline|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884842|NCT01133522|B7|Baseline|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
884843|NCT01133522|B6|Baseline|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884844|NCT01133522|B5|Baseline|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884845|NCT01133522|B4|Baseline|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884846|NCT01133522|B3|Baseline|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884847|NCT01133522|B2|Baseline|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884848|NCT01133522|B1|Baseline|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
884849|NCT01133522|P10|Participant Flow|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884850|NCT01133522|P9|Participant Flow|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
884851|NCT01133522|P8|Participant Flow|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884852|NCT01133522|P7|Participant Flow|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
884853|NCT01133522|P6|Participant Flow|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks (Q4W) for 8 weeks.
884854|NCT01133522|P5|Participant Flow|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884855|NCT01133522|P4|Participant Flow|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks (Q2W) for 6 weeks.
884856|NCT01133522|P3|Participant Flow|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884857|NCT01133522|P2|Participant Flow|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly (QW) for 6 weeks.
884858|NCT01133522|P1|Participant Flow|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
884859|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884983|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884862|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
890163|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
884863|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884864|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884865|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884866|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884867|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884868|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
884869|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884870|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
884871|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884872|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
884873|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884874|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884875|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884876|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884877|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884878|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
884879|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884880|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884881|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884882|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884883|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884884|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884885|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884886|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884887|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
884888|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884889|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
884890|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884891|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884892|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884893|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884894|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884895|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
884896|NCT01133522|O7|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884897|NCT01133522|O6|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
885838|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
884898|NCT01133522|O5|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884899|NCT01133522|O4|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884900|NCT01133522|O3|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884901|NCT01133522|O2|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884902|NCT01133522|O1|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884903|NCT01133522|O10|Outcome|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884904|NCT01133522|O9|Outcome|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
884905|NCT01133522|O8|Outcome|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884906|NCT01133522|O7|Outcome|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
884907|NCT01133522|O6|Outcome|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884908|NCT01133522|O5|Outcome|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884909|NCT01133522|O4|Outcome|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884910|NCT01133522|O3|Outcome|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884911|NCT01133522|O2|Outcome|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884912|NCT01133522|O1|Outcome|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
884913|NCT01133522|E10|Reported Event|HeFH - Evolocumab 140 mg Q2W × 3|Cohort 7: Participants diagnosed with HeFH received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884914|NCT01133522|E9|Reported Event|HeFH - Placebo|Cohort 7: Participants diagnosed with HeFH received placebo subcutaneous injection every 2 weeks for 6 weeks.
884915|NCT01133522|E8|Reported Event|High Dose Statin - Evolocumab 140 mg Q2W × 3|Cohort 6: Participants on high-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884916|NCT01133522|E7|Reported Event|High Dose Statin - Placebo|Cohort 6: Participants on high-dose statin therapy received placebo subcutaneous injection every 2 weeks for 6 weeks.
884917|NCT01133522|E6|Reported Event|Evolocumab 420 mg Q4W × 2|Cohort 5: participants on low-to-moderate-dose statin therapy received evolocumab 420 mg subcutaneous injection every 4 weeks for 8 weeks.
884918|NCT01133522|E5|Reported Event|Evolocumab 280 mg Q2W × 3|Cohort 4: Participants on low-to-moderate-dose statin therapy received evolocumab 280 mg subcutaneous injection every 2 weeks for 6 weeks.
884919|NCT01133522|E4|Reported Event|Evolocumab 140 mg Q2W × 3|Cohort 3: Participants on low-to-moderate-dose statin therapy received evolocumab 140 mg subcutaneous injection every 2 weeks for 6 weeks.
884920|NCT01133522|E3|Reported Event|Evolocumab 35 mg QW × 6|Cohort 2: Participants on low-to-moderate-dose statin therapy received evolocumab 35 mg subcutaneous injection once weekly for 6 weeks.
884921|NCT01133522|E2|Reported Event|Evolocumab 14 mg QW × 6|Cohort 1: Participants on low-to-moderate-dose stain therapy received evolocumab 14 mg subcutaneous injection once weekly for 6 weeks.
884922|NCT01133522|E1|Reported Event|Placebo|Cohorts 1-5 Combined: Participants on low-to-moderate dose statin therapy received placebo subcutaneous injections matching active investigational product in volume and frequency.
884923|NCT01133418|B3|Baseline|Total|Total of all reporting groups
884924|NCT01133418|B2|Baseline|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
884925|NCT01133418|B1|Baseline|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
884926|NCT01133418|P2|Participant Flow|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
884984|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
890164|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
884927|NCT01133418|P1|Participant Flow|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
884928|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
884929|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
884930|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
884931|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
884932|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
884933|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
884934|NCT01133418|O2|Outcome|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
884935|NCT01133418|O1|Outcome|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
884979|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884980|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
892178|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
884936|NCT01133418|E2|Reported Event|Non-progressive Cognitive Training|"Children in the control condition will participate in the same tasks as children in the Intervention arm. They will experience the same number of blocks and trials of training as the intervention group. Further, their training will be conducted by the same set of trainers and for the same amount of time as the intervention group. However, children in the control group will remain at the lowest level for each CT task throughout training irrespective of performance.~Sham Comparator Cognitive Training: Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty"
884937|NCT01133418|E1|Reported Event|Cognitive Training|"Computerized Progressive Attention Training~Computerized Progressive Attention Training: Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability"
884938|NCT01133392|B3|Baseline|Total|Total of all reporting groups
884939|NCT01133392|B2|Baseline|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA.
884940|NCT01133392|B1|Baseline|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB.
884941|NCT01133392|P2|Participant Flow|Insulin Lispro Dosing Sequence BABA|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence BABA. There was an interval of approximately 4 to 7 days between doses.
884942|NCT01133392|P1|Participant Flow|Insulin Lispro Dosing Sequence ABAB|Each participant was administered insulin lispro A formulation (Treatment A, test – 2 occasions) and insulin lispro B formulation (Treatment B, reference – 2 occasions) in the dosing sequence ABAB. There was an interval of approximately 4 to 7 days between doses.
884943|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
884944|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
884945|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
884946|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
884947|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
884948|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
884949|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
884950|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
884951|NCT01133392|O2|Outcome|Insulin Lispro B|20 units (U) administered subcutaneously (SC)
884952|NCT01133392|O1|Outcome|Insulin Lispro A|20 units (U) administered subcutaneously (SC)
884953|NCT01133392|E2|Reported Event|Insulin Lispro B|Insulin lispro B formulation (Treatment B, reference – 2 occasions)
884954|NCT01133392|E1|Reported Event|Insulin Lispro A|Insulin lispro A formulation (Treatment A, test – 2 occasions)
884955|NCT01133379|B4|Baseline|Total|Total of all reporting groups
884956|NCT01133379|B3|Baseline|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884957|NCT01133379|B2|Baseline|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884958|NCT01133379|B1|Baseline|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884959|NCT01133379|P3|Participant Flow|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884960|NCT01133379|P2|Participant Flow|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884961|NCT01133379|P1|Participant Flow|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884962|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884963|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884964|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884965|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884966|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884967|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884968|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884969|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884970|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884971|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884972|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884973|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884974|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884975|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884976|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884977|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884985|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884986|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884987|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884988|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884989|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884990|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884991|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884992|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884993|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884994|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884995|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884996|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
884997|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
884998|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
884999|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
885000|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
885001|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
885002|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
885003|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
885004|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
885005|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
885006|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
885007|NCT01133379|O3|Outcome|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
885008|NCT01133379|O2|Outcome|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
885009|NCT01133379|O1|Outcome|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
885010|NCT01133379|E3|Reported Event|12027-020|1.40% Potassium Oxalate Sensitive Mouth Rinse with Fluoride (20 mL)
885011|NCT01133379|E2|Reported Event|12027-019|1.40% Potassium Oxalate Sensitive Mouth Rinse without Fluoride (10 mL)
885012|NCT01133379|E1|Reported Event|12027-021 (Vehicle Control)|Vehicle Control Mouth Rinse (without Potassium Oxalate and without Fluoride) (10 mL)
885013|NCT01133288|B1|Baseline|Yulex Glove|Yulex Glove Treatment
885014|NCT01133288|P1|Participant Flow|Yulex Glove|Yulex Glove Treatment
885015|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
885016|NCT01133288|O1|Outcome|Yulex Glove|Yulex Glove Treatment
885017|NCT01133288|E1|Reported Event|Yulex Glove|Yulex Glove Treatment
885018|NCT01133275|B1|Baseline|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
885019|NCT01133275|P1|Participant Flow|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
885020|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
885021|NCT01133275|O1|Outcome|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
885022|NCT01133275|E1|Reported Event|Lenalidomide and Prednisone Therapy|Lenalidomide and prednisone therapy for 6 cycles (24 weeks). Each cycle is 28 days (4 weeks).
885023|NCT01133171|B4|Baseline|Total|Total of all reporting groups
885024|NCT01133171|B3|Baseline|Control|
885025|NCT01133171|B2|Baseline|Nurse Alone|
885026|NCT01133171|B1|Baseline|Dashboard Plus Nurse|
885027|NCT01133171|P3|Participant Flow|Control|
885028|NCT01133171|P2|Participant Flow|Nurse Alone|
885029|NCT01133171|P1|Participant Flow|Dashboard Plus Nurse|
885030|NCT01133171|O3|Outcome|Control|
885031|NCT01133171|O2|Outcome|Nurse Alone|
885032|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
885033|NCT01133171|O2|Outcome|Nurse Alone|
885034|NCT01133171|O1|Outcome|Dashboard Plus Nurse|
885035|NCT01133171|E3|Reported Event|Control|
885036|NCT01133171|E2|Reported Event|Nurse Alone|
885037|NCT01133171|E1|Reported Event|Dashboard Plus Nurse|
885038|NCT01132846|B4|Baseline|Total|Total of all reporting groups
885039|NCT01132846|B3|Baseline|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885040|NCT01132846|B2|Baseline|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885125|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
885126|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
890159|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
885041|NCT01132846|B1|Baseline|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885042|NCT01132846|P3|Participant Flow|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885043|NCT01132846|P2|Participant Flow|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885044|NCT01132846|P1|Participant Flow|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885045|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885046|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885047|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885048|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885049|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885050|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885051|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885052|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885053|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885054|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885055|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885056|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885057|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885058|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885059|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885060|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885061|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885062|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
892179|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
885063|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885064|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885065|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885066|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885067|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885068|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885069|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885070|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885071|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885072|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885073|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885074|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885075|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885076|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885077|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885078|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885079|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885080|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885081|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885082|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885083|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885084|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885839|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
885085|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885086|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885087|NCT01132846|O3|Outcome|Low Dose Nesiritide|"Drug: Nesiritide Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885088|NCT01132846|O2|Outcome|Placebo|"Drug: Placebo Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885089|NCT01132846|O1|Outcome|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885090|NCT01132846|E3|Reported Event|Low Dose Nesiritide|"Drug: Nesiritide~Participants could be randomized to receive low dose nesiritide or placebo during the first 72 hours in the trial.~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
885091|NCT01132846|E2|Reported Event|Placebo|"Drug: Placebo~Participants will receive placebo in place of low dose dopamine or low dose nesiritide depending on randomization.~Placebo: Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic."
885092|NCT01132846|E1|Reported Event|Low Dose Dopamine|"Drug: Dopamine~Participants will be randomized to receive low dose dopamine or placebo during first 72 hours of participation in the study~Dopamine: Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial."
885093|NCT01132690|B3|Baseline|Total|Total of all reporting groups
885094|NCT01132690|B2|Baseline|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885095|NCT01132690|B1|Baseline|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885096|NCT01132690|P2|Participant Flow|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885097|NCT01132690|P1|Participant Flow|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885098|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885099|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885100|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885101|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885102|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885103|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885104|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885105|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885106|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885107|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885108|NCT01132690|O2|Outcome|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885109|NCT01132690|O1|Outcome|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885110|NCT01132690|E2|Reported Event|60 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885111|NCT01132690|E1|Reported Event|30 Units/kg|Taliglucerase alfa: Taliglucerase alfa for infusion every two weeks for 12 months
885112|NCT01132664|B6|Baseline|Total|Total of all reporting groups
885113|NCT01132664|B5|Baseline|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885114|NCT01132664|B4|Baseline|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885115|NCT01132664|B3|Baseline|Phase II - 100mg|Patients in the phase II only expansion cohort who received 100 mg of buparlisib - investigational drug
885116|NCT01132664|B2|Baseline|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
885117|NCT01132664|B1|Baseline|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
885118|NCT01132664|P5|Participant Flow|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885119|NCT01132664|P4|Participant Flow|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885120|NCT01132664|P3|Participant Flow|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib dose escalation were included in phase II and received 100 mg of investigational drug - buparsilib
885121|NCT01132664|P2|Participant Flow|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
885122|NCT01132664|P1|Participant Flow|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
885123|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885124|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885127|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
885128|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885129|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885130|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
885131|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
885132|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
885133|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885134|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885135|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
885136|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
885137|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
885138|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885139|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885140|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
885141|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
885142|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
885143|NCT01132664|O5|Outcome|BM Cohort - 100mg|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885144|NCT01132664|O4|Outcome|BM Cohort - 80mg|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885145|NCT01132664|O3|Outcome|Phase II - 100mg|Patients in the phase II expansion + patients from phase Ib escalation included in phase II
885146|NCT01132664|O2|Outcome|Phase Ib - 100mg|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
885147|NCT01132664|O1|Outcome|Phase Ib - 50 mg|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug
885148|NCT01132664|E5|Reported Event|BM Cohort 100 mg/Day|Patients in the BM cohort who received 100 mg of buparlisib - investigational drug
885149|NCT01132664|E4|Reported Event|BM Cohort 80 mg/Day|Patients in the BM cohort who received 80 mg of buparlisib - investigational drug
885150|NCT01132664|E3|Reported Event|Phase II Dose Expansion 100 mg/Day|Patients in the phase II expansion + patients from phase Ib dose escalation who received 100 mg/day of buparlisib - investigational drug
885151|NCT01132664|E2|Reported Event|Phase Ib Dose Escalation 100 mg/Day|Patients in the phase Ib dose escalation cohort who received 100 mg of buparlisib - investigational drug
885152|NCT01132664|E1|Reported Event|Phase Ib Dose Escalation 50 mg/Day|Patients in the phase Ib dose escalation cohort who received 50 mg of buparlisib - investigational drug.
885153|NCT01132651|B3|Baseline|Total|Total of all reporting groups
885154|NCT01132651|B2|Baseline|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
885155|NCT01132651|B1|Baseline|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
885156|NCT01132651|P2|Participant Flow|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
885157|NCT01132651|P1|Participant Flow|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
885158|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
885159|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
885160|NCT01132651|O2|Outcome|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
885161|NCT01132651|O1|Outcome|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
885162|NCT01132651|E2|Reported Event|Control (Normal Pillow)|This group of subjects served as the control group. They followed their current eczema regimen and slept on their normal pillow at night.
885163|NCT01132651|E1|Reported Event|Chillow (Cooling Pillow)|This group of subjects followed their current eczema regimen with the addition of sleeping on the cooling pillow at night.
885164|NCT01132547|B3|Baseline|Total|Total of all reporting groups
885165|NCT01132547|B2|Baseline|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
885166|NCT01132547|B1|Baseline|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
885167|NCT01132547|P2|Participant Flow|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
885168|NCT01132547|P1|Participant Flow|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
885169|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
885170|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
885171|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
885172|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
885173|NCT01132547|O2|Outcome|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
885174|NCT01132547|O1|Outcome|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
885175|NCT01132547|E2|Reported Event|Arm II Placebo|"Patients receive an oral placebo twice daily for 8 weeks.~placebo: Given orally"
885176|NCT01132547|E1|Reported Event|Arm I Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for 8 weeks.~cyproheptadine hydrochloride: Given orally"
885177|NCT01132508|B1|Baseline|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885178|NCT01132508|P1|Participant Flow|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885179|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885180|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885181|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885182|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885183|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885184|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885185|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885186|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885187|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885188|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885189|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885240|NCT01132495|P2|Participant Flow|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
885840|NCT01130103|E2|Reported Event|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
885190|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885191|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885192|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885193|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885194|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885195|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885196|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885197|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885198|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885199|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885200|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885201|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885202|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885203|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885204|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885336|NCT01132144|B2|Baseline|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885205|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885206|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885207|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885208|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885209|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885210|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885211|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885212|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885213|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885214|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885215|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885216|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885217|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885218|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885219|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885841|NCT01130103|E1|Reported Event|Paroxetine|Paroxetine and Prolonged Exposure Therapy
885220|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885221|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885222|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885223|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885224|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885225|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885226|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885227|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885228|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885229|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885230|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885231|NCT01132508|O1|Outcome|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885232|NCT01132508|E1|Reported Event|Treatment|Norian Drillable Bone Void Filler: Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
885233|NCT01132495|B5|Baseline|Total|Total of all reporting groups
885234|NCT01132495|B4|Baseline|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
885235|NCT01132495|B3|Baseline|Cohort B - Follow-up|Observation with treatment based on physician preference
885236|NCT01132495|B2|Baseline|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
885237|NCT01132495|B1|Baseline|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
885238|NCT01132495|P4|Participant Flow|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
885239|NCT01132495|P3|Participant Flow|Cohort B - Follow-up|Observation with treatment based on physician preference
892180|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
885241|NCT01132495|P1|Participant Flow|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
885242|NCT01132495|O2|Outcome|Cohort A - OMT Alone|Optimal medical treatment alone - Standard of care: OMT alone
885243|NCT01132495|O1|Outcome|Cohort A - PCI Plus OMT|PCI plus optimal medical treatment - Stenting plus OMT: FFR guided PCI, plus OMT
885244|NCT01132495|E4|Reported Event|Cohort B - No Follow-up Re-consented|Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data
885245|NCT01132495|E3|Reported Event|Cohort B - Follow-up|Observation with treatment based on physician preference
885246|NCT01132495|E2|Reported Event|Cohort A - OMT Alone|"Optimal medical treatment alone~Standard of care: OMT alone"
885247|NCT01132495|E1|Reported Event|Cohort A - PCI Plus OMT|"PCI plus optimal medical treatment~Stenting plus OMT: FFR guided PCI, plus OMT"
885248|NCT01132378|B1|Baseline|Median Parepatellar Approach or Minimidvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
885249|NCT01132378|P1|Participant Flow|Mini-midvastus Incision|"Total knee arthroplasty : staged bilateral total knee arthroplasty~Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini-midvastus approach in one knee and mini-Medial Parapatellar Approachthe in another knee (left or right)within no more than 7 days."
885250|NCT01132378|O2|Outcome|Mini-midvastus Approach|Total knee arthroplasty : staged bilateral total knee arthroplasty
885251|NCT01132378|O1|Outcome|Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
885252|NCT01132378|E1|Reported Event|Midvastus or Medial Parapatellar Approach|Forty consecutive patients who underwent staged bilateral Total Knee Arthroplasty were prospectively randomised to receive mini MedialParapatellar Approach in one knee and mini-midvastus approach in the other knee (left or right)within no more than 7 days.
885253|NCT01132326|B1|Baseline|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
885254|NCT01132326|P1|Participant Flow|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
885255|NCT01132326|O1|Outcome|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
885256|NCT01132326|E1|Reported Event|Droxidopa|"Open-Label Droxidopa~Droxidopa: Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months"
885257|NCT01132313|B13|Baseline|Total|Total of all reporting groups
885258|NCT01132313|B12|Baseline|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885259|NCT01132313|B11|Baseline|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885260|NCT01132313|B10|Baseline|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885261|NCT01132313|B9|Baseline|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885262|NCT01132313|B8|Baseline|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885263|NCT01132313|B7|Baseline|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885264|NCT01132313|B6|Baseline|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885265|NCT01132313|B5|Baseline|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885266|NCT01132313|B4|Baseline|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885267|NCT01132313|B3|Baseline|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885268|NCT01132313|B2|Baseline|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
885269|NCT01132313|B1|Baseline|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
885270|NCT01132313|P12|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885917|NCT01129557|B2|Baseline|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
885271|NCT01132313|P11|Participant Flow|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885272|NCT01132313|P10|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885273|NCT01132313|P9|Participant Flow|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885274|NCT01132313|P8|Participant Flow|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885275|NCT01132313|P7|Participant Flow|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885276|NCT01132313|P6|Participant Flow|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885277|NCT01132313|P5|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885278|NCT01132313|P4|Participant Flow|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885279|NCT01132313|P3|Participant Flow|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885280|NCT01132313|P2|Participant Flow|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
885281|NCT01132313|P1|Participant Flow|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
885282|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885283|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885284|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885285|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885286|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885287|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885288|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885289|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885290|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885291|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885292|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885421|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885422|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885293|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885294|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885295|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885296|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885297|NCT01132313|O7|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885298|NCT01132313|O6|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885299|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885300|NCT01132313|O4|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885301|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885302|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
885303|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
885304|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885305|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885306|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885307|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885308|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885309|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
885310|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
885311|NCT01132313|O5|Outcome|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885312|NCT01132313|O4|Outcome|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885313|NCT01132313|O3|Outcome|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885423|NCT01131676|E3|Reported Event|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885314|NCT01132313|O2|Outcome|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885315|NCT01132313|O1|Outcome|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885316|NCT01132313|O5|Outcome|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885317|NCT01132313|O4|Outcome|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885318|NCT01132313|O3|Outcome|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885319|NCT01132313|O2|Outcome|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885320|NCT01132313|O1|Outcome|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885321|NCT01132313|O2|Outcome|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
885322|NCT01132313|O1|Outcome|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
885323|NCT01132313|E12|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 24w|Part 4: 24 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885324|NCT01132313|E11|Reported Event|Part 4: 600 mg DBV and 120mg FDV - 16w|Part 4: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet.
885325|NCT01132313|E10|Reported Event|Part 3: 600mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885326|NCT01132313|E9|Reported Event|Part 3: 800mg DBV and 120mg FDV - 24w|Part 3: 24 weeks of 800mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885327|NCT01132313|E8|Reported Event|Part 3: 600mg DBV and 120mg FDV - 16w|Part 3: 16 weeks of 600mg Deleobuvir tablet BID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885328|NCT01132313|E7|Reported Event|Part 2: 600mg DBV and 120mg FDV, no RBV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD, without RBV. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885329|NCT01132313|E6|Reported Event|Part 2: 600mg DBV BID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet twice a day (BID) and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885330|NCT01132313|E5|Reported Event|Part 2: 600mg DBV and 120mg FDV - 40w|Part 2: 40 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885331|NCT01132313|E4|Reported Event|Part 2: 600mg DBV TID and 120mg FDV - 28w|Part 2: 28 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885332|NCT01132313|E3|Reported Event|Part 2: 600mg DBV and 120mg FDV - 16w|Part 2: 16 weeks of 600mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. Patients who discontinued their assigned treatment early due to lack of antiviral activity could receive additional treatment with PegIFN/RBV for up to 24 weeks.
885333|NCT01132313|E2|Reported Event|Part 1: 600mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 600mg Deleobuvir (DBV, BI 207127) tablet three times per day (TID) and 120mg Faldaprevir (FDV, BI 201335) soft gelatin capsule once daily (QD) in combination with Ribavirin (RBV) tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with SOC PegIFN/RBV (triple therapy period)
885334|NCT01132313|E1|Reported Event|Part 1: 400mg DBV and 120mg FDV - 4w|Part 1: 4 weeks of 400mg Deleobuvir tablet TID and 120mg Faldaprevir soft gelatin capsule QD in combination with RBV tablet. From week 5 to week 24, patients received treatment with FDV 120mg QD in combination with standard of care (SOC) PegIFN/RBV (triple therapy period)
885335|NCT01132144|B3|Baseline|Total|Total of all reporting groups
885337|NCT01132144|B1|Baseline|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885338|NCT01132144|P2|Participant Flow|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
885339|NCT01132144|P1|Participant Flow|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885340|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885341|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885342|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885343|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885344|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885345|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885346|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885347|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885348|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885349|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885350|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds
885351|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885352|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885353|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885354|NCT01132144|O2|Outcome|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
885355|NCT01132144|O1|Outcome|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation.
885356|NCT01132144|E2|Reported Event|Control Group|Introduction of the speculum and wiping of the cervix with gaze for 30 seconds.
886163|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
885357|NCT01132144|E1|Reported Event|Endometrial Injury Group|Endometrial biopsy was performed once with a pipelle de Cornier® in the month before initiating controlled ovarian stimulation. The pipelle was introduced gently through the cervix up to the uterine fundus. The piston was then drawn back to the end of the biopsy cannula until it self-locks and creates a negative pressure. Aiming to wound the entire endometrium, the examiner applied regular back-and-forth movements while rotating the sampler covering the whole uterine cavity. This procedure was continued until fragments of uterine mucosa appeared within the sheath, which generally took 30 seconds.
885358|NCT01132118|B3|Baseline|Total|Total of all reporting groups
885359|NCT01132118|B2|Baseline|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885360|NCT01132118|B1|Baseline|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885361|NCT01132118|P2|Participant Flow|Placebo Then HCQ|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885362|NCT01132118|P1|Participant Flow|HCQ Then Placebo|"This arm of the study contains half the study population after randomization. The participants in this arm received hydroxychloroquine for 8 weeks and then crossed over to a placebo for 8 weeks. Study staff was blinded to which order they were taking the hydroxychloroquine and placebo in.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885363|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
885364|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885365|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
885366|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885367|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
885368|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885369|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
885370|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885371|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
885372|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885373|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
885374|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885375|NCT01132118|O2|Outcome|Placebo|This arm group contains the results for patients while they were on placebo.
885376|NCT01132118|O1|Outcome|Hydroxychloroquine|"This group contains results for when study participants were taking hydroxychlorquine.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided was based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885377|NCT01132118|E2|Reported Event|Placebo|Participants received Placebo tablets for 8 weeks.
885424|NCT01131676|E2|Reported Event|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885425|NCT01131676|E1|Reported Event|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885378|NCT01132118|E1|Reported Event|Hydroxychloroquine|"Participants received hydroxychloroquine (HCQ) for 8 weeks.~Hydroxychloroquine: Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg."
885379|NCT01131884|B3|Baseline|Total|Total of all reporting groups
885380|NCT01131884|B2|Baseline|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
885381|NCT01131884|B1|Baseline|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
885382|NCT01131884|P2|Participant Flow|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
885383|NCT01131884|P1|Participant Flow|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
885384|NCT01131884|O2|Outcome|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
885385|NCT01131884|O1|Outcome|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
885386|NCT01131884|E2|Reported Event|Placebo Sugar Pill|"Double blind study using Fosamax versus placebo. Placebo is an inactive drug.~Placebo : Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo."
885387|NCT01131884|E1|Reported Event|Fosamax|Fosamax : 70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
885388|NCT01131676|B4|Baseline|Total|Total of all reporting groups
885389|NCT01131676|B3|Baseline|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885390|NCT01131676|B2|Baseline|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885391|NCT01131676|B1|Baseline|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885392|NCT01131676|P3|Participant Flow|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885393|NCT01131676|P2|Participant Flow|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885394|NCT01131676|P1|Participant Flow|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885395|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
885396|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885397|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885398|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885399|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
885400|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885401|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885402|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885403|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
885404|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885405|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885406|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885407|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
885408|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885409|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885410|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885411|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
885412|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885413|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885414|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885415|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
885416|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885417|NCT01131676|O2|Outcome|Empagliflozin 10 mg|Oral administration of Empagliflozin 10 mg (BI 10773) film coated tablets (1 tablet once daily)
885418|NCT01131676|O1|Outcome|Placebo|Oral administration of Placebo matching empagliflozin 10 mg or 25 mg (1 tablet once daily)
885419|NCT01131676|O4|Outcome|All Empagliflozin|Patients who received either 10 mg or 25 mg of empagliflozin were pooled into a common empagliflozin treatment group
885420|NCT01131676|O3|Outcome|Empagliflozin 25 mg|Oral administration of Empagliflozin 25 mg (BI 10773) film coated tablets (1 tablet once daily)
885426|NCT01131585|B3|Baseline|Total|Total of all reporting groups
885427|NCT01131585|B2|Baseline|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885428|NCT01131585|B1|Baseline|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885429|NCT01131585|P2|Participant Flow|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885430|NCT01131585|P1|Participant Flow|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885431|NCT01131585|O2|Outcome|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885432|NCT01131585|O1|Outcome|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885433|NCT01131585|E2|Reported Event|Active Laser Photocoagulation and Sham Injection|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Sham intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885434|NCT01131585|E1|Reported Event|Active Laser Photocoagulation and Ranibizumab|"Active laser treatment applied at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.~Ranibizumab intravitreal injection given at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment."
885435|NCT01131507|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
885436|NCT01131507|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
885437|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
885438|NCT01131507|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
885439|NCT01131507|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose was adjusted based on participants' age and body weight. Total dose not to exceed 10,000 lipase units per kg body weight per day unless clinically indicated. Total duration of study treatment was up to 12 months.
885440|NCT01131494|B1|Baseline|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
885441|NCT01131494|P1|Participant Flow|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
885442|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
885443|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
885444|NCT01131494|O2|Outcome|Post-intervention Measure|Measurements of the group made after the intervention.
885445|NCT01131494|O1|Outcome|Pre-intervention Measure|Measurements of the group made before begin intervention.
885446|NCT01131494|E1|Reported Event|Swallowing Exercise Group|One group made swallowing exercises for five weeks. This group was compared before and after the study.
885447|NCT01131455|B4|Baseline|Total|Total of all reporting groups
885485|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885486|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
892181|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
885448|NCT01131455|B3|Baseline|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
885449|NCT01131455|B2|Baseline|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
885450|NCT01131455|B1|Baseline|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
885451|NCT01131455|P3|Participant Flow|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
885452|NCT01131455|P2|Participant Flow|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
885453|NCT01131455|P1|Participant Flow|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
885454|NCT01131455|O3|Outcome|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
885455|NCT01131455|O2|Outcome|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
885456|NCT01131455|O1|Outcome|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
885487|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885457|NCT01131455|E3|Reported Event|Standard-Fusion +Autograft Only|Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with blunt dissection through the capsule and penetration to the joint. Depending on the randomization of the subject, ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.
885458|NCT01131455|E2|Reported Event|Fusion + ACP +DBM|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus and external rotation and neutral foot dorsiflexion). Depending on the randomization of the subject, (Autologous Concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and then reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use."
885459|NCT01131455|E1|Reported Event|Fusion+ACP+Autograft|"Standard anatomic reduction will be adhered to- neutral alignment will be employed (5° valgus, external rotation and neutral foot dorsiflexion). The arthrodesis undertaken for all groups will be the standard arthroscopic ankle arthrodesis with portals to the ankle (anterior medial / anterior lateral), skin incision only technique with dissection through the capsule and penetration to the joint. Standard debridement of the gutters, tibia osteophyte, tibia-talor joint resection and autograft preparation will be performed in the joint. Depending on randomization of the subject, (Autologous concentrated Plasma)ACP-A or ACP-DBM mixture will be added to the arthrodesis site with the joint taken through range of direct motion and reduced.~Autologous Concentrated Plasma: Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a h"
885460|NCT01131299|B1|Baseline|Alpha Cyclodextrin & Placebo Participants|"Randomized subjects receiving alpha cyclodextrin~Alpha cyclodextrin: 2 g PO 3 times a day for 12- 14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
885461|NCT01131299|P2|Participant Flow|Alpha Cyclodextrin First, Then Placebo|"Subjects will receive alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks. After a one-week washout, the subjects will receive placebo.~Subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks"
885462|NCT01131299|P1|Participant Flow|Placebo First, Then Alpha Cyclodextrin|"Randomized subjects will receive placebo 2 tablets orally (three times a day) for 12-14 weeks. After a one-week washout, the subjects will receive alpha cyclodextrin.~Alpha cyclodextrin: 2 tablets PO 3 times a day for 12-14 weeks"
885463|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885464|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885465|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885466|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885467|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885468|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885469|NCT01131299|O2|Outcome|Placebo|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885470|NCT01131299|O1|Outcome|a-CD|Change in total serum cholesterol after 12-14 weeks intervention, compared to baseline
885471|NCT01131299|E1|Reported Event|Entire Study Population|"Randomized subjects receiving active comparator~Alpha cyclodextrin: 2g PO 3 times a day for 12-14 weeks~Randomized subjects receiving placebo comparator~Placebo: 2 tablets PO 3 times a day for 12-14 weeks"
885472|NCT01131182|B3|Baseline|Total|Total of all reporting groups
885473|NCT01131182|B2|Baseline|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription. All participants as treated population, n=514.
885474|NCT01131182|B1|Baseline|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period. All participants as treated population, n=507.
885475|NCT01131182|P2|Participant Flow|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription
885476|NCT01131182|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period
885477|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
885478|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
885479|NCT01131182|O2|Outcome|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
885480|NCT01131182|O1|Outcome|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
885481|NCT01131182|E2|Reported Event|Sulfonylurea|Sulfonylurea administered orally daily over the Ramadan period as per physician's prescription.
885482|NCT01131182|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg administered orally daily over the Ramadan period.
885483|NCT01131130|B1|Baseline|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
885484|NCT01131130|P1|Participant Flow|Over All Study|Participants were equally randomized to one of six treatment sequences of the investigational RD2106 contact lens (Test), the Air Optix Aqua contact lens, and the Acuvue Oasys contact lens. Crossover occurred following 1 week of lens wear. The 6 groups were as follows Test, Air Optix Aqua, Acuvue Oasys; Test, Acuvue Oasys, Air Optix Aqua; Air Optix Aqua, Test, Acuvue Oasys; Air Optix Aqua, Acuvue Oasys, Test; Acuvue Oasys, Test, Air Optix Aqua; Acuvue Oasys, Air Optix Aqua, Test.
886594|NCT01128153|E2|Reported Event|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
885488|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885489|NCT01131130|O2|Outcome|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885490|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885491|NCT01131130|O2|Outcome|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885492|NCT01131130|O1|Outcome|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885493|NCT01131130|E3|Reported Event|Air Optix Aqua|"Ciba Vision~Air Optix Aqua: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885494|NCT01131130|E2|Reported Event|Acuvue Oasys Contact Lens|"Johnson & Johnson Lens~Acuvue Oasys Contact Lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885495|NCT01131130|E1|Reported Event|Investigational Contact Lens|"Bausch & Lomb~Investigational contact lens: After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type."
885496|NCT01131078|B4|Baseline|Total|Total of all reporting groups
885497|NCT01131078|B3|Baseline|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885498|NCT01131078|B2|Baseline|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885499|NCT01131078|B1|Baseline|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885500|NCT01131078|P3|Participant Flow|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885501|NCT01131078|P2|Participant Flow|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885502|NCT01131078|P1|Participant Flow|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 milligrams per kilogram (mg/kg) intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 milligrams per meter squared (mg/m^2) intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or stable disease (SD) were treated with bevacizumab alone until unacceptable toxicity, progressive disease (PD), or participant withdrawal.
885503|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885504|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885505|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885638|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885506|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885507|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885508|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885509|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885510|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885511|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885512|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885513|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885514|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885515|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885516|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885517|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885518|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885545|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885519|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885520|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885521|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885522|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885523|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885524|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885525|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885526|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885527|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885528|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885529|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885530|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885531|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal..
885560|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
885532|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885533|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885534|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885535|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885536|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885537|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885538|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885539|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885540|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885541|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885542|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885543|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885544|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885607|NCT01130974|E2|Reported Event|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
885608|NCT01130974|E1|Reported Event|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885546|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885547|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885548|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885549|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885550|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885551|NCT01131078|O3|Outcome|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of continuous capecitabine treatment. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885552|NCT01131078|O2|Outcome|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3-week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885553|NCT01131078|O1|Outcome|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885554|NCT01131078|E3|Reported Event|Bevacizumab + Capecitabine (650 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.
885555|NCT01131078|E2|Reported Event|Bevacizumab + Capecitabine (1250 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885556|NCT01131078|E1|Reported Event|Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.
885557|NCT01131065|B1|Baseline|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
885558|NCT01131065|P1|Participant Flow|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
885559|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
885637|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885561|NCT01131065|O1|Outcome|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
885562|NCT01131065|E1|Reported Event|Hepatitis B Immune Globulin|"Treatment group~Hepatitis B immune globulin: Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively."
885563|NCT01131052|B3|Baseline|Total|Total of all reporting groups
885564|NCT01131052|B2|Baseline|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885565|NCT01131052|B1|Baseline|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885566|NCT01131052|P2|Participant Flow|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885567|NCT01131052|P1|Participant Flow|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885568|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885569|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885570|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885571|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885572|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885573|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885574|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885575|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885576|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885577|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885578|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885579|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885580|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885581|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885582|NCT01131052|O2|Outcome|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885583|NCT01131052|O1|Outcome|Basal Plus|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885584|NCT01131052|E2|Reported Event|Sliding Scale Regular Insulin (SSRI)|Diabetic subjects receive sliding scale regular insulin (SSRI) before meals and at bedtime as needed
885585|NCT01131052|E1|Reported Event|BASAL PLUS|Diabetic subjects receive glargine once daily plus corrective doses of glulisine before meals and bedtime as needed
885586|NCT01130974|B3|Baseline|Total|Total of all reporting groups
885587|NCT01130974|B2|Baseline|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
885588|NCT01130974|B1|Baseline|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885589|NCT01130974|P2|Participant Flow|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
885590|NCT01130974|P1|Participant Flow|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885591|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
885592|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885593|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
885594|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885595|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
885596|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885597|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
885598|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885599|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
885600|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885601|NCT01130974|O2|Outcome|Marketed Contact Lens|Marketed daily disposable cosmetic tint contact lens
885602|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885603|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
885604|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885605|NCT01130974|O2|Outcome|Marketed Daily Disposable Contact Lens|Marketed daily disposable cosmetic tint contact lens
885606|NCT01130974|O1|Outcome|Bausch & Lomb Contact Lens|Bausch & Lomb daily disposable cosmetic tint contact lens
885609|NCT01130883|B1|Baseline|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885610|NCT01130883|P1|Participant Flow|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885611|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885612|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885613|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885614|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885615|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885616|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885617|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885618|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885619|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885620|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885621|NCT01130883|O1|Outcome|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885622|NCT01130883|E1|Reported Event|Klacid SR Treatment|Adult Czech participants with acute tracheitis, acute tracheobronchitis or acute bronchitis; or participants with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) who received Klacid SR treatment 6 weeks to 24 months prior to the Klacid SR dose dose administered within this study.
885623|NCT01130844|B4|Baseline|Total|Total of all reporting groups
885624|NCT01130844|B3|Baseline|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885625|NCT01130844|B2|Baseline|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885626|NCT01130844|B1|Baseline|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885627|NCT01130844|P3|Participant Flow|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885628|NCT01130844|P2|Participant Flow|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885629|NCT01130844|P1|Participant Flow|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885630|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885631|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885632|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885633|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885634|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885635|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885636|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
892182|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
885639|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885640|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885641|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885642|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885643|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885644|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885645|NCT01130844|O3|Outcome|MMX Mesalamine Metabolite (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885646|NCT01130844|O2|Outcome|MMX Mesalamine Metabolite (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885647|NCT01130844|O1|Outcome|MMX Mesalamine Metabolite (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885648|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885649|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885650|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885651|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885652|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885653|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885654|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885655|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885656|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885657|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885658|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885659|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885660|NCT01130844|O3|Outcome|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885661|NCT01130844|O2|Outcome|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885662|NCT01130844|O1|Outcome|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885663|NCT01130844|E3|Reported Event|MMX Mesalamine (100 mg/kg)|MMX Mesalamine: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885664|NCT01130844|E2|Reported Event|MMX Mesalamine (60 mg/kg)|MMX Mesalamine: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885665|NCT01130844|E1|Reported Event|MMX Mesalamine (30mg/kg)|MMX Mesalamine: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
885666|NCT01130831|B1|Baseline|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885667|NCT01130831|P1|Participant Flow|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885668|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885669|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885670|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885671|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885672|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy for >=3 months prior.
885673|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885674|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|Calcium-based phosphate binder therapy of >=3 months of treatment.
885675|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885676|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885677|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885678|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885679|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885680|NCT01130831|O1|Outcome|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885681|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the iPTH KDOQI target on lanthanum carbonate.
885682|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum phosphate KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
885683|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium-phosphorous product KDOQI target on lanthanum carbonate.
885684|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum calcium KDOQI target on lanthanum carbonate.
885685|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that maintained the serum phosphorous KDOQI target on lanthanum carbonate.
885686|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium-phosphorous product levels KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
885687|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium-phosphorous product KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
885688|NCT01130831|O1|Outcome|Lanthanum Carbonate|The percent of subjects that achieved the serum calcium KDOQI target on lanthanum carbonate after previous calcium-based phosphate binder therapy treatment for >=3 months.
885689|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum calcium KDOQI target on previous calcium-based phosphate binder therapy for >=3 months prior to receiving lanthanum carbonate treatment.
885690|NCT01130831|O1|Outcome|Calcium-based Phosphate Binder Therapy|The percent of subjects that achieved the serum phosphate KDOQI target on previous calcium-based phosphate binder therapy of >=3 months of treatment prior to receiving lanthanum carbonate treatment.
885691|NCT01130831|E1|Reported Event|Lanthanum Carbonate|Lanthanum carbonate therapy after previous calcium-based phosphate binder therapy treatment for >=3 months.
885692|NCT01130740|B3|Baseline|Total|Total of all reporting groups
885693|NCT01130740|B2|Baseline|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
885694|NCT01130740|B1|Baseline|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
885695|NCT01130740|P2|Participant Flow|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
885696|NCT01130740|P1|Participant Flow|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
885697|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
885698|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
885699|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
885700|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
885701|NCT01130740|O2|Outcome|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
885702|NCT01130740|O1|Outcome|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
885703|NCT01130740|E2|Reported Event|Osteoarthritis Intervention|"Osteoarthritis Intervention - Primary care providers receive patient-specific osteoarthritis information and treatment recommendations approximately one week prior to the patient's first post-enrollment routine appointment with PCP; patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.~Osteoarthritis Intervention: Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management."
885704|NCT01130740|E1|Reported Event|Usual Care|Participants received no intervention durnig the study period but continued with any other usual care for osteoarthritis.
892183|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
885705|NCT01130597|B1|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885706|NCT01130597|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885707|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885708|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885709|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885710|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885711|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885712|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885713|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885714|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885715|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885716|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885717|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885718|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885719|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885720|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885721|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885760|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885918|NCT01129557|B1|Baseline|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
885722|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885723|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885724|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885725|NCT01130597|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885726|NCT01130597|E1|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (20 g/day, administered as a divided dose of 10 g in the morning and 10 g in the evening) and spironolactone (25 mg/day, administered once daily), orally. After Day 3, at the first occurrence of a serum potassium value of ≤ 5.1 mEq/L, the spironolactone dose was increased once to 50 mg/day; dose reductions were not allowed."
885727|NCT01130532|B4|Baseline|Total|Total of all reporting groups
885728|NCT01130532|B3|Baseline|Placebo|Placebo for 12 weeks during double-blind treatment period.
885729|NCT01130532|B2|Baseline|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
885730|NCT01130532|B1|Baseline|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
885731|NCT01130532|P4|Participant Flow|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
885732|NCT01130532|P3|Participant Flow|Placebo|Placebo for 12 weeks during double-blind treatment period.
885733|NCT01130532|P2|Participant Flow|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
885734|NCT01130532|P1|Participant Flow|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
885735|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885736|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885737|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885738|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885739|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885740|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885741|NCT01130532|O3|Outcome|Placebo (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885742|NCT01130532|O2|Outcome|5 mg Tadalafil (Period IV)|5.0 mg Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885743|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period IV)|5.0 milligram (mg) Tadalafil for 4 weeks during open-label extension treatment period (Period IV).
885744|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885745|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885746|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885747|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885748|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885749|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885750|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885751|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885752|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885753|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885754|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885755|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885756|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885757|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885758|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885759|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885761|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885762|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885763|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885764|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885765|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885766|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885767|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885768|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885769|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885770|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885771|NCT01130532|O3|Outcome|Placebo (Period III)|Placebo for 12 weeks during double-blind treatment period (Period III).
885772|NCT01130532|O2|Outcome|5 mg Tadalafil (Period III)|5.0 mg Tadalafil for 12 weeks during double-blind treatment period (Period III).
885773|NCT01130532|O1|Outcome|2.5 mg Titrated to 5 mg Tadalafil (Period III)|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period (Period III).
885774|NCT01130532|E4|Reported Event|5 mg Tadalafil Open-Label Extension|5 mg Tadalafil for 4 weeks during open-label treatment extension period.
885775|NCT01130532|E3|Reported Event|Placebo|Placebo for 12 weeks during double-blind treatment period.
885776|NCT01130532|E2|Reported Event|5 mg Tadalafil|5.0 mg Tadalafil for 12 weeks during double-blind treatment period.
885777|NCT01130532|E1|Reported Event|2.5 mg Titrated to 5 mg Tadalafil|2.5 milligram (mg) Tadalafil for 4 weeks, followed by 5 mg Tadalafil for 8 weeks during double-blind treatment period.
885778|NCT01130337|B1|Baseline|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
885779|NCT01130337|P1|Participant Flow|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 milligrams per meter squared [mg/m^2] tablet orally [p.o] twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute intravenous [IV] infusion, Day 1 of the cycle)/trastuzumab (8 milligrams per kilograms [mg/kg] on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
885780|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
885781|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
885782|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
885783|NCT01130337|O1|Outcome|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
885784|NCT01130337|E1|Reported Event|Capecitabine+Oxaliplatin+Trastuzumab|Participants received 3 cycles of capecitabine (1,000 mg/m^2 tablet p.o twice daily, Days 1-14)/oxaliplatin (130 mg/m^2 as a 120-minute IV infusion Day 1 of the cycle)/trastuzumab (8 mg/kg on Day 1, followed by doses of 6 mg/kg as IV infusion) (XELOX-trastuzumab) as neoadjuvant treatment, every 3 weeks, thereafter, they were assessed for surgery. After surgery, participants received 3 cycles of XELOX-trastuzumab as treatment adjuvant to the surgery, thereafter, another 12 cycles of trastuzumab as monotherapy, was administered every 3 weeks, until disease progression or death.
885785|NCT01130168|B1|Baseline|All Participants|
885786|NCT01130168|P6|Participant Flow|Amlodipine/ISMN ER/Placebo (Sequence 6)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule for 4 weeks during Period, with a 2-week washout between each period.
885787|NCT01130168|P5|Participant Flow|Placebo/Amlodipine/ISMN ER (Sequence 5)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period.
885788|NCT01130168|P4|Participant Flow|ISMN ER/Placebo/Amlodipine (Sequence 4)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period.
885789|NCT01130168|P3|Participant Flow|Amlodipine/Placebo/ISMN ER (Sequence 3)|Participants received Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 1, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 2, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
885790|NCT01130168|P2|Participant Flow|ISMN ER/Amlodipine/Placebo (Sequence 2)|Participants received a ISMN ER 30 mg capsule orally for 4 weeks during Period 1, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 2, followed by a dose-matched Placebo capsule orally for 4 weeks during Period 3, with a 2-week washout between each period
885791|NCT01130168|P1|Participant Flow|Placebo/ISMN ER/Amlodipine (Sequence 1)|Participants received a dose-matched Placebo capsule orally for 4 weeks during Period 1, followed by a ISMN ER 30 mg capsule orally for 4 weeks during Period 2, followed by Amlodipine 10 mg (two 5 mg capsules) orally for 4 weeks during Period 3, with a 2-week washout between each period. Experimental: ISMN ER/Amlodipine/Placebo
885792|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885793|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885794|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885795|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885796|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885797|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885798|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885799|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885800|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885801|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885802|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885803|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885804|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885805|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885806|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885807|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885808|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885809|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885810|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885811|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885812|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885813|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885814|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885815|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885816|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885817|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885818|NCT01130168|O1|Outcome|ISMN ER|ISMN ER was administered as a 30 mg single daily dose over 4 weeks.
885819|NCT01130168|O3|Outcome|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885820|NCT01130168|O2|Outcome|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885821|NCT01130168|O1|Outcome|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
885822|NCT01130168|E3|Reported Event|Amlodipine|Amlodipine was administered as a 10 mg single daily dose over 4 weeks.
885823|NCT01130168|E2|Reported Event|ISMN ER|Isosorbide mononitrate extended release (ISMN ER) was administered as a 30 mg single daily dose over 4 weeks.
885824|NCT01130168|E1|Reported Event|Placebo|Placebo was administered as a single once daily dose during 4 weeks of treatment.
885825|NCT01130103|B3|Baseline|Total|Total of all reporting groups
885826|NCT01130103|B2|Baseline|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
885827|NCT01130103|B1|Baseline|Paroxetine|Paroxetine and Prolonged Exposure Therapy
885828|NCT01130103|P2|Participant Flow|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
885829|NCT01130103|P1|Participant Flow|Paroxetine|Paroxetine and Prolonged Exposure Therapy
885830|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
885831|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
885832|NCT01130103|O2|Outcome|Placebo Pill|Placebo pill plus Prolonged Exposure Therapy
885833|NCT01130103|O1|Outcome|Paroxetine|Paroxetine and Prolonged Exposure Therapy
885842|NCT01130051|B1|Baseline|Colcrys® Intact Tab and Colcrys® in Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
885843|NCT01130051|P2|Participant Flow|Colcrys® Sprinkled on Applesauce Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours
885844|NCT01130051|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Sprinkled on Applesauce|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce, after an overnight fast of at least 10 hours
885845|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
885846|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
885847|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
885848|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
885849|NCT01130051|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|Each subject received one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce after an overnight fast of at least 10 hours
885850|NCT01130051|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
885851|NCT01130051|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Sprinkled on Applesauce|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
885852|NCT01130051|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and sprinkled on applesauce, following an overnight fast of at least 10 hours.
885853|NCT01129960|B5|Baseline|Total|Total of all reporting groups
885854|NCT01129960|B4|Baseline|Placebo|Placebo: Tablets will be used.
885855|NCT01129960|B3|Baseline|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885856|NCT01129960|B2|Baseline|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885857|NCT01129960|B1|Baseline|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
885858|NCT01129960|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
885859|NCT01129960|P3|Participant Flow|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885860|NCT01129960|P2|Participant Flow|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885861|NCT01129960|P1|Participant Flow|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
885862|NCT01129960|O4|Outcome|Placebo|Placebo: Tablets will be used.
885863|NCT01129960|O3|Outcome|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885864|NCT01129960|O2|Outcome|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885865|NCT01129960|O1|Outcome|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
885866|NCT01129960|E4|Reported Event|Placebo|Placebo: Tablets will be used.
885867|NCT01129960|E3|Reported Event|Esl 800 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885868|NCT01129960|E2|Reported Event|Esl 1200 mg|Eslicarbazepine acetate (BIA 2-093) mg QD: Tablets will be used.
885869|NCT01129960|E1|Reported Event|Esl 1600 mg|Eslicarbazepine acetate (Esl) (BIA 2-093) mg once daily (QD): Tablets will be used.
885870|NCT01129921|B3|Baseline|Total|Total of all reporting groups
885871|NCT01129921|B2|Baseline|Sham Procedure|Group 2: sham decompression with trocar placement and no bone or tissue removal
885872|NCT01129921|B1|Baseline|Mild Procedure|Group 1: mild percutaneous decompression with removal of bone and tissue
885873|NCT01129921|P2|Participant Flow|Sham Then Percutaneous Decompression With Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
885874|NCT01129921|P1|Participant Flow|Percutaneous Decompression Procedure Only|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
885875|NCT01129921|O2|Outcome|Sham Then Percutaneous Decompression With Mild|Sham Group 2 Year-1 Cohort: After cross-over to the active mild procedure study arm in which bone and tissue were removed using the mild device kit.
885876|NCT01129921|O1|Outcome|Percutaneous Decompression Procedure Only|Mild Group 1 Year-1 Cohort: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
885877|NCT01129921|O2|Outcome|Sham Group 2 Year-1 Cohort After X-over to Mild|Group 2: After post-treatment Week 6 and prior to Week 12, patients in Sham procedure arm were allowed to participate in the active (mild procedure) study arm in which bone and tissue were removed using the mild device kit.
885878|NCT01129921|O1|Outcome|Mild Group 1 Year-1 Cohort|Group 1: Percutaneous decompression procedure with removal of bone and tissue using the mild device kit
885879|NCT01129921|O2|Outcome|Sham Procedure Group 2 Prior to Cross-over|Sham placement of trocar as in percutaneous decompression, with no bone or tissue removal.
885880|NCT01129921|O1|Outcome|Mild Procedure Group 1|Percutaneous decompression with removal of small amounts of bone and tissue to relieve stenosis.
885881|NCT01129921|E2|Reported Event|Sham Procedure With Optional Crossover to Mild Post-unblinding|Sham procedure includes percutaneous trocar placement with no tissue or bone removal.
885882|NCT01129921|E1|Reported Event|Mild Procedure|percutaneous decompression with bone and tissue removal
885883|NCT01129778|B1|Baseline|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
885884|NCT01129778|P1|Participant Flow|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
885885|NCT01129778|O1|Outcome|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
885886|NCT01129778|O1|Outcome|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
885887|NCT01129778|E1|Reported Event|Received Zegerid (Ome-NaBic)|Ome-NaBic 40 mg orally 1 h before breakfast and bedtime for up to 29 days
885888|NCT01129765|B1|Baseline|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885889|NCT01129765|P1|Participant Flow|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885890|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885891|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885892|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885893|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885894|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885895|NCT01129765|O1|Outcome|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885896|NCT01129765|E1|Reported Event|Parents of Congested Children|Parents of children less than six years of age with nasal congestion for which nasal suctioning and salt water irrigation is traditionally recommended.
885897|NCT01129622|B1|Baseline|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
885898|NCT01129622|P1|Participant Flow|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
885899|NCT01129622|O1|Outcome|Adverse Events|Hypo-estrogenic side effects
885900|NCT01129622|O1|Outcome|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
885901|NCT01129622|E1|Reported Event|Letrozole, Breast Enhancement, Safety|Single arm of healthy postmenopausal women to have two breast MRI (baseline and post-treatment). Letrozole of 12.5 mg/day is given for three successive days just prior to the second MRI.
885902|NCT01129583|B3|Baseline|Total|Total of all reporting groups
885903|NCT01129583|B2|Baseline|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885904|NCT01129583|B1|Baseline|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885905|NCT01129583|P2|Participant Flow|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885906|NCT01129583|P1|Participant Flow|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885907|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885908|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885909|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885910|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885911|NCT01129583|O2|Outcome|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885912|NCT01129583|O1|Outcome|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885913|NCT01129583|E2|Reported Event|Saline|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885914|NCT01129583|E1|Reported Event|Botulinum Toxin|Intraoperative injection of 100 U into biceps and 100 U into brachialis following surgical treatment of an elbow fracture or elbow fracture dislocation.
885915|NCT01129557|B4|Baseline|Total|Total of all reporting groups
885916|NCT01129557|B3|Baseline|Tekturna+Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
887276|NCT01126060|B2|Baseline|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
885919|NCT01129557|P3|Participant Flow|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
885920|NCT01129557|P2|Participant Flow|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
885921|NCT01129557|P1|Participant Flow|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
885922|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
885923|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885924|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
885925|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885926|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
885927|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885928|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
885929|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885930|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
885931|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885932|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
885933|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885934|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
885935|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885936|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
885937|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885938|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
885939|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885940|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
885941|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885942|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
885943|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885944|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
885945|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885946|NCT01129557|O4|Outcome|Final: Subjects With Aldosterone Breakthrough|
885947|NCT01129557|O3|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885948|NCT01129557|O2|Outcome|Final: Subjects Without Aldosterone Breakthrough|
885949|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885950|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
885951|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
885952|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
885953|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885954|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
885955|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
885956|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
885957|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885958|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
885959|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
885960|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
885961|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885962|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
885963|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
885964|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
885965|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885966|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
885967|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
885968|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
885969|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885970|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
885971|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
885972|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
885973|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885974|NCT01129557|O8|Outcome|9 Months: Subjects With Aldosterone Breakthrough|
885975|NCT01129557|O7|Outcome|6 Months: Subjects With Aldosterone Breakthrough|
885976|NCT01129557|O6|Outcome|3 Months: Subjects With Aldosterone Breakthrough|
885977|NCT01129557|O5|Outcome|Baseline: Subjects With Aldosterone Breakthrough|
885978|NCT01129557|O4|Outcome|9 Months: Subjects Without Aldosterone Breakthrough|
885979|NCT01129557|O3|Outcome|6 Months: Subjects Without Aldosterone Breakthrough|
885980|NCT01129557|O2|Outcome|3 Months: Subjects Without Aldosterone Breakthrough|
885981|NCT01129557|O1|Outcome|Baseline: Subjects Without Aldosterone Breakthrough|
885982|NCT01129557|O3|Outcome|Tekturna + Diovan|aliskiren + valsartan (DRI + ARB) : Tekturna 150 mg PO once daily + Diovan 160 mg PO once daily for 9 months
885983|NCT01129557|O2|Outcome|Tekturna|aliskiren [direct renin inhibitor (DRI)] : Tekturna 300 mg PO once daily for 9 months
885984|NCT01129557|O1|Outcome|Diovan|valsartan [angiotensin receptor blocker (ARB)] : Diovan 320 mg PO once daily for 9 months
885985|NCT01129557|E3|Reported Event|Tekturna + Diovan|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 150 mg by mouth once daily for 9 months & Diovan (Valsartan), an angiotensin receptor blocker (ARB) 160 mg by mouth once daily for 9 months
885986|NCT01129557|E2|Reported Event|Diovan|Diovan (Valsartan), an angiotensin receptor blocker (ARB) 320 mg by mouth once daily for 9 months
892184|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
885987|NCT01129557|E1|Reported Event|Tekturna|Tekturna (Aliskiren), a direct renin inhibitor (DRI) 300 mg by mouth once daily for 9 months
885988|NCT01129531|B4|Baseline|Total|Total of all reporting groups
885989|NCT01129531|B3|Baseline|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
885990|NCT01129531|B2|Baseline|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
885991|NCT01129531|B1|Baseline|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
885992|NCT01129531|P3|Participant Flow|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
885993|NCT01129531|P2|Participant Flow|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
885994|NCT01129531|P1|Participant Flow|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
885995|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
885996|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
885997|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
885998|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment. Participants received two treatments 12 weeks apart.
885999|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
886000|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
886001|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
886002|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
886003|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
886004|NCT01129531|O3|Outcome|Placebo|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
886005|NCT01129531|O2|Outcome|AGN-214868 16.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg per treatment.
886006|NCT01129531|O1|Outcome|AGN-214868 3.25 μg|AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg per treatment.
886007|NCT01129531|E6|Reported Event|Placebo_Cycle 2|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
886008|NCT01129531|E5|Reported Event|AGN-214868 16.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
886009|NCT01129531|E4|Reported Event|AGN-214868 3.25 μg_ Cycle 2|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
886010|NCT01129531|E3|Reported Event|Placebo_Cycle 1|One treatment of Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain.
886011|NCT01129531|E2|Reported Event|AGN-214868 16.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 16.25 μg.
886012|NCT01129531|E1|Reported Event|AGN-214868 3.25 μg_Cycle 1|One treatment of AGN-214868 injected into areas of postherpetic neuralgia pain for a total dose of 3.25 μg.
886013|NCT01129336|B3|Baseline|Total|Total of all reporting groups
886014|NCT01129336|B2|Baseline|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
886015|NCT01129336|B1|Baseline|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
886016|NCT01129336|P2|Participant Flow|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
886017|NCT01129336|P1|Participant Flow|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
886018|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
886019|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
886020|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
886021|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
886022|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
886023|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
886024|NCT01129336|O2|Outcome|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
886025|NCT01129336|O1|Outcome|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
886026|NCT01129336|E2|Reported Event|Patients With Bone Metastases|Patients with bone metastasis received standard therapy + zoledronic acid for 18 months (discontinued upon disease progression/secondary malignancy)
886027|NCT01129336|E1|Reported Event|Patients Without Bone Metastases|Patients with no bone metastasis were randomized into a 1:1 ratio to standard therapy plus zoledronic acid 4mg IV Zoledronic acid administration monthly during Months 1-18.
886028|NCT01129284|B4|Baseline|Total|Total of all reporting groups
886029|NCT01129284|B3|Baseline|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease)
886030|NCT01129284|B2|Baseline|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD)
886031|NCT01129284|B1|Baseline|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy
886032|NCT01129284|P3|Participant Flow|Immunoglobulin A (IgA) Nephropathy|Subjects diagnosed with Immunoglobulin A (IgA) nephropathy (Berger's disease) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
886033|NCT01129284|P2|Participant Flow|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD) were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
886034|NCT01129284|P1|Participant Flow|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy were treated with ACTH gel (80 units subcutaneously twice a week) for 6 months.
886035|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886036|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886037|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886038|NCT01129284|O3|Outcome|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886039|NCT01129284|O2|Outcome|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886040|NCT01129284|O1|Outcome|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886041|NCT01129284|E3|Reported Event|IgA Nephropathy|Subjects diagnosed with IgA nephropathy (Berger's disease), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886042|NCT01129284|E2|Reported Event|FSGS/MCD|Subjects diagnosed with focal segmental glomerulosclerosis (FSGS) or minimal change disease (MCD), treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886043|NCT01129284|E1|Reported Event|Membranous Nephropathy|Subjects diagnosed with membranous nephropathy, treated with ACTH gel (80 units subcutaneously twice a week) for 6 months
886044|NCT01129245|B3|Baseline|Total|Total of all reporting groups
886045|NCT01129245|B2|Baseline|Celecoxib First, Then Placebo|control menstrual cycle, celecoxib menstrual cycle, placebo menstrual cycle
886046|NCT01129245|B1|Baseline|Placebo First, Then Celecoxib|control menstrual cycle, placebo menstrual cycle, and then celecoxib menstrual cycle
886047|NCT01129245|P2|Participant Flow|Celecoxib First, Then Placebo|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings~Placebo"
886048|NCT01129245|P1|Participant Flow|Placebo First, Then Celecoxib|"receive celebrex based on hormone and ultrasound findings and timing of menstrual cycle~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings~Placebo"
886049|NCT01129245|O2|Outcome|Placebo|received placebo during menstrual cycle
886050|NCT01129245|O1|Outcome|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
886051|NCT01129245|E2|Reported Event|Placebo|received placebo drug
886052|NCT01129245|E1|Reported Event|Celebrex|"receive celebrex at pre-determined time in menstrual cycle based on hormone levels and ultrasound results~celebrex: 400 mg PO daily intermittently based on hormone and ultrasound findings"
886053|NCT01129206|B1|Baseline|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
886054|NCT01129206|P1|Participant Flow|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
886055|NCT01129206|O2|Outcome|RECIST Criteria Per CT|
886056|NCT01129206|O1|Outcome|PERCIST Criteria Per PET|
886057|NCT01129206|O1|Outcome|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
886058|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
886089|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886090|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
892185|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
886059|NCT01129206|O1|Outcome|Arm I: Pralatrexate and Docetaxel|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
886060|NCT01129206|E1|Reported Event|Arm I|"Patients receive pralatrexate IV over 3-5 minutes and docetaxel IV on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~pralatrexate: IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.~docetaxel: Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.~fludeoxyglucose F 18: Correlative studies~positron emission tomography: Correlative studies"
886061|NCT01129141|B3|Baseline|Total|Total of all reporting groups
886062|NCT01129141|B2|Baseline|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
886063|NCT01129141|B1|Baseline|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
886064|NCT01129141|P2|Participant Flow|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
886065|NCT01129141|P1|Participant Flow|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
886066|NCT01129141|O2|Outcome|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
886067|NCT01129141|O1|Outcome|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
886068|NCT01129141|E2|Reported Event|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
886069|NCT01129141|E1|Reported Event|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
886070|NCT01129128|B4|Baseline|Total|Total of all reporting groups
886071|NCT01129128|B3|Baseline|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886072|NCT01129128|B2|Baseline|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
886073|NCT01129128|B1|Baseline|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886074|NCT01129128|P3|Participant Flow|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886075|NCT01129128|P2|Participant Flow|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
886076|NCT01129128|P1|Participant Flow|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886077|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886078|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
886079|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886080|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886081|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
886082|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886083|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886084|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
886085|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886086|NCT01129128|O3|Outcome|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886087|NCT01129128|O2|Outcome|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
886088|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886091|NCT01129128|O1|Outcome|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886092|NCT01129128|E3|Reported Event|Placebo|Inert liquid that is similar in appearance and taste to the active Echinacea products
886093|NCT01129128|E2|Reported Event|Commercially Available Echinacea Product #2 (1 ml/Dose)|Echinacea purpurea product; 1 ml dose administered three times daily for 10 days
886094|NCT01129128|E1|Reported Event|Commercially Available Echinacea Product #1 (5 ml/Dose)|Echinacea purpurea product; 5 ml dose administered three times daily for 10 days
886095|NCT01129115|B5|Baseline|Total|Total of all reporting groups
886096|NCT01129115|B4|Baseline|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886097|NCT01129115|B3|Baseline|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886098|NCT01129115|B2|Baseline|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886099|NCT01129115|B1|Baseline|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886100|NCT01129115|P4|Participant Flow|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886101|NCT01129115|P3|Participant Flow|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886102|NCT01129115|P2|Participant Flow|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886103|NCT01129115|P1|Participant Flow|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886104|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886105|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886106|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886107|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886108|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886109|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886110|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886111|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886112|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886113|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886114|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886115|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886116|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886117|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886118|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886119|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886162|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886120|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886121|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886122|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886123|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886124|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886125|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886126|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886127|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886128|NCT01129115|O4|Outcome|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886129|NCT01129115|O3|Outcome|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886130|NCT01129115|O2|Outcome|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886131|NCT01129115|O1|Outcome|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886132|NCT01129115|E4|Reported Event|Aerobic Exercise Group 3|Aerobic Exercise Group 3: The 150% group will perform 225 minutes a week of exercise over 4 – 5 days.
886133|NCT01129115|E3|Reported Event|Aerobic Exercise Group 2|Aerobic Exercise Group 2: The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
886134|NCT01129115|E2|Reported Event|Aerobic Exercise Group 1|Aerobic Exercise Group 1: The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
886135|NCT01129115|E1|Reported Event|Nonexercise Control Group|Nonexercise control group: Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
886136|NCT01129102|B4|Baseline|Total|Total of all reporting groups
886137|NCT01129102|B3|Baseline|Placebo|Placebo for NPC-01
886138|NCT01129102|B2|Baseline|IKH-01|Norethisterone 1mg, Ethinyl estradiol 0.035mg
886139|NCT01129102|B1|Baseline|NPC-01|Norethisterone 1mg, Ethinyl estradiol 0.02mg
886140|NCT01129102|P3|Participant Flow|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
886141|NCT01129102|P2|Participant Flow|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
886142|NCT01129102|P1|Participant Flow|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
886143|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
886144|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
886145|NCT01129102|O2|Outcome|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
886146|NCT01129102|O1|Outcome|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
886147|NCT01129102|E3|Reported Event|Placebo|"Placebo for NPC-01~Placebo: Placebo for NPC-01"
886148|NCT01129102|E2|Reported Event|IKH-01|"Norethisterone 1mg, Ethinyl estradiol 0.035mg~IKH-01: Norethisterone 1mg, Ethinyl estradiol 0.035mg"
886149|NCT01129102|E1|Reported Event|NPC-01|"Norethisterone 1mg, Ethinyl estradiol 0.02mg~NPC-01: Norethisterone 1mg, Ethinyl estradiol 0.02mg"
886150|NCT01129011|B3|Baseline|Total|Total of all reporting groups
886151|NCT01129011|B2|Baseline|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886152|NCT01129011|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886153|NCT01129011|P2|Participant Flow|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886154|NCT01129011|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886155|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886156|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886157|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886158|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886159|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886160|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886161|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886164|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886165|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886166|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886167|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886168|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886169|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886170|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886171|NCT01129011|O2|Outcome|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886172|NCT01129011|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886173|NCT01129011|E2|Reported Event|Naproxen|Naproxen 500 mg dosed twice daily (bid)
886174|NCT01129011|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg dosed twice daily (bid)
886175|NCT01128972|B1|Baseline|All Study Participants|All randomized participants were included for baseline evaluation.
886176|NCT01128972|P5|Participant Flow|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886177|NCT01128972|P4|Participant Flow|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886178|NCT01128972|P3|Participant Flow|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference sodium monofluorophosphate (NaMFP)/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886179|NCT01128972|P2|Participant Flow|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886180|NCT01128972|P1|Participant Flow|Test Dentifrice + Test Mouth Rinse (MR)|Participants were administered with treatment regimen comprising of test sodium fluoride (NaF) dentifrice [containing 1450 parts per million (ppm) fluoride (F) as NaF and potassium nitrate (KNO3)] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5 gram (g) test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886181|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886182|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886183|NCT01128972|O2|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886184|NCT01128972|O1|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886185|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
892186|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
886186|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886187|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886188|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886189|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886190|NCT01128972|O5|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886191|NCT01128972|O4|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886192|NCT01128972|O3|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886193|NCT01128972|O2|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886194|NCT01128972|O1|Outcome|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886195|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886196|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886197|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886198|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886199|NCT01128972|O4|Outcome|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886200|NCT01128972|O3|Outcome|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886201|NCT01128972|O2|Outcome|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886202|NCT01128972|O1|Outcome|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886203|NCT01128972|E5|Reported Event|Placebo Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886204|NCT01128972|E4|Reported Event|Placebo Dentifrice + Test MR|Participants were administered with treatment regimen comprising of placebo dentifrice (0ppmF) and test MR containing NaF (450ppmF). The treatment regimen included application of 1.5g placebo dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886205|NCT01128972|E3|Reported Event|Reference Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of reference NaMFP/ NaF dentifrice (1450ppmF) and placebo sterile water MR. The treatment regimen included application of 1.5g reference dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886206|NCT01128972|E2|Reported Event|Test Dentifrice + Sterile Water Rinse|Participants were administered with treatment regimen comprising of test NaF Dentifrice (1450ppmF) and placebo sterile water rinse. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of sterile water rinse for one minute.
886207|NCT01128972|E1|Reported Event|Test Dentifrice + Test MR|Participants were administered with treatment regimen comprising of test NaF dentifrice [containing 1450ppmF as NaF and KNO3] and test NaF (450ppmF) MR. The treatment regimen included application of 1.5g test NaF dentifrice to a wet study toothbrush, brushing for 25 seconds to create a dentifrice slurry, swished the slurry around the mouth for one minute. After one minute, participants expectorated the slurry and rinsed the mouth with tap water. One hour later, the participants rinsed the mouth with 15mL of test MR for one minute.
886208|NCT01128959|B1|Baseline|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
886209|NCT01128959|P1|Participant Flow|Intravenous Carbamazepine (IV CBZ)|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
886210|NCT01128959|O2|Outcome|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
886211|NCT01128959|O1|Outcome|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|Intravenous Carbamazepine (IV CBZ): 10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
886212|NCT01128959|E2|Reported Event|Intravenous Carbamazepine (IV CBZ) 5 Minutes Infusion|
886213|NCT01128959|E1|Reported Event|Intravenous Carbamazepine (IV CBZ) 15 Minutes Infusion|
886214|NCT01128946|B1|Baseline|Overall|All randomized participants
886215|NCT01128946|P4|Participant Flow|NaF Toothpaste (675ppmF|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
887854|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
886216|NCT01128946|P3|Participant Flow|Strontium Fluoride (SnF)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886217|NCT01128946|P2|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures
886218|NCT01128946|P1|Participant Flow|Sodium Fluoride (NaF) Toothpaste(1450 Parts Per Million(Ppm)F|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 gram (g) NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 milliliters (mL) water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886219|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886220|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886221|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886222|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886223|NCT01128946|O4|Outcome|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886224|NCT01128946|O3|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886225|NCT01128946|O2|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886226|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886227|NCT01128946|O2|Outcome|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886228|NCT01128946|O1|Outcome|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886229|NCT01128946|E4|Reported Event|SnF/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g SnF toothpaste (1100ppmF as SnF and 350ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886230|NCT01128946|E3|Reported Event|NaMFP/NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with 1.5g NaMFP and NaF toothpaste (1000ppmF as NaMFP and 450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886398|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886231|NCT01128946|E2|Reported Event|NaF Toothpaste (675ppmF)|Participants brushed their natural teeth twice daily, for one timed minute with NaF toothpaste (675ppmF as NaF), followed by rinsing with 15mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886232|NCT01128946|E1|Reported Event|NaF Toothpaste (1450ppmF)|Participants brushed their natural teeth twice daily, for one timed minute, with 1.5 g NaF toothpaste (1450ppmF as NaF), followed by rinsing with 15 mL water for 10 seconds. Participants continued the study brushing/rinsing regimen at home twice daily for 14 days with instructions to not brush the enamel specimens. Participants wore their partial dentures 24-hours a day, except when cleaning their dentures.
886233|NCT01128894|B3|Baseline|Total|Total of all reporting groups
886234|NCT01128894|B2|Baseline|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886235|NCT01128894|B1|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886236|NCT01128894|P2|Participant Flow|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886237|NCT01128894|P1|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886238|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886239|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886240|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886241|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886242|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886243|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886244|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886245|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886246|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886247|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886248|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886249|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886250|NCT01128894|O2|Outcome|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886251|NCT01128894|O1|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886252|NCT01128894|E2|Reported Event|Liraglutide 1.8 mg|Participants received liraglutide 0.6 mg once daily (OD) SC from Baseline until Week 1. From Week 1 to Week 2 the dose was increased to 1.2 mg. At Week 2, the dose was increased to 1.8 mg.
886253|NCT01128894|E1|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously (SC) from Baseline until Week 6 with up-titration to 50 mg weekly at Week 6.
886254|NCT01128829|B1|Baseline|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
886255|NCT01128829|P2|Participant Flow|"Sucralose Then Water"|"First intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load."
886256|NCT01128829|P1|Participant Flow|"Water Then Sucralose"|"First intervention (1 day) subjects drank 60 ml of water 10 min before drinking a 75 g glucose load.~Washout (~ 7 days) Second intervention (1 day) subjects drank 60 ml of 2 mmolar sucralose 10 min before drinking a 75 g glucose load."
886257|NCT01128829|O1|Outcome|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
886258|NCT01128829|E1|Reported Event|Obese Non Regular Users of Non Nutritive Sweeteners (NNS)|Obese subjects who do not use NNS and are “insulin-sensitive” (based on a Homeostasis Model Assessment of Insulin Resistance score <or =2.6).
886259|NCT01128738|B3|Baseline|Total|Total of all reporting groups
886399|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886595|NCT01128153|E1|Reported Event|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886260|NCT01128738|B2|Baseline|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886261|NCT01128738|B1|Baseline|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886262|NCT01128738|P2|Participant Flow|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886263|NCT01128738|P1|Participant Flow|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886264|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886265|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886266|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886267|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886268|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886269|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886270|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886285|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
892187|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
886271|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886272|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886273|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886274|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886275|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886276|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886277|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886278|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886279|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886280|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886281|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886282|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886283|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886284|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886643|NCT01127659|P1|Participant Flow|Diabetes With HH: Testosterone|"active drug diabetes arm~testosterone: intramuscular every 2 weeks"
886286|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886287|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886288|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886289|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886290|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886291|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886292|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886293|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886294|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886295|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886296|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886297|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886298|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886299|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886644|NCT01127659|O6|Outcome|Eugonadal Obese|obese non-diabetic men with normal testosterone
886300|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886301|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886302|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886303|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886304|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886305|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886306|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886307|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886308|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886309|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886310|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886311|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886312|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886389|NCT01128595|P1|Participant Flow|Sequence 1: VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received Vilanterol (VI) 25 micrograms (µg), placebo, fluticasone furoate (FF) 100 µg, and FF/VI 100/25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
886313|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886314|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886315|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886316|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886317|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886318|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886319|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886320|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886321|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886322|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886323|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886324|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886325|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886326|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886645|NCT01127659|O5|Outcome|Eugonadal Diabetes|"diabetic men with normal testosterone~Glucose infusion rate: 10.29+/-5.55 mg/kg fat-free mass/min"
886327|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886328|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886329|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886330|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886331|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886332|NCT01128738|O3|Outcome|Total|Total comprises all participants who received BTX 50 U/axillae in the Second Treatment Phase.
886333|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886334|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886335|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886336|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886337|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886390|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886391|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886392|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886338|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886339|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886340|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886341|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886342|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886343|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886344|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886345|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886346|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886347|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886393|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886348|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886349|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886350|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886351|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886352|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886353|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886354|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886355|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886356|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886357|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886394|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886358|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886359|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886360|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886361|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886362|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886363|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886364|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886365|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886366|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886367|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886395|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886368|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886369|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886370|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886371|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886372|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886373|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886374|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886375|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886376|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886377|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886396|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886378|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886379|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886380|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886381|NCT01128738|O2|Outcome|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886382|NCT01128738|O1|Outcome|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886383|NCT01128738|E2|Reported Event|Placebo in First TP; BTX 50 U in Second TP|Placebo was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase. BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase. Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received an injection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886384|NCT01128738|E1|Reported Event|BTX 50 U in First and Second TPs|Botulinum toxin type A (BTX) (GSK1358820) 50 units per axilla (underarm) (50 U/axilla) was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the First Treatment Phase (16- to 40-week period after first treatment). BTX 50 U/axilla was injected intradermally to the hyperhidrotic area of both axillae at 10 to 15 injection sites during the Second Treatment Phase (16- to 24-week period after reinjection). Participants who had a mean sweat production (measured by gravimetric assessment) in both axillae of beyond 50% of their Baseline (Week 0) level at any point in time during Weeks 16, 20, or 24 received a reinjection of BTX. Only participants who received this second treatment entered into the Second Treatment Phase.
886385|NCT01128595|B1|Baseline|Placebo, FF/VI 100/25 µg OD, FF 100 µg OD, VI 25 µg|All participants received one of the following four treatments in one of four treatment periods once daily (OD) from the Dry Powder Inhaler (DPI) for 21 days: Placebo; Fluticasone Furoate /Vilanterol (FF/VI) 100/25 microgram (µg) dry inhalation powder; Fluticasone Furoate (FF) 100 µg dry inhalation powder; and Vilanterol (VI) 25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the four following sequences: (1) VI 25 µg, Placebo, FF 100 µg, FF/VI 100/25 µg; (2) FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg; (3) Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg; (4) FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo. The four treatment periods were separated by a washout period of 21 to 35 days.
886386|NCT01128595|P4|Participant Flow|Sequence 4: FF 100 µg, VI 25 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, VI 25 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
886387|NCT01128595|P3|Participant Flow|Sequence 3: Placebo, FF/VI 100/25 µg, VI 25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, VI 25 µg, and FF 100 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
886388|NCT01128595|P2|Participant Flow|Sequence 2: FF/VI 100/25 µg, FF 100 µg, Placebo, VI 25 µg|Participants received FF/VI 100/25 µg, FF 100 µg, placebo, and VI 25 µg in Treatment Periods 1, 2, 3, and 4, respectively. Participants received all treatments once a day (OD) for 21 days from a Dry Powder Inhaler (DPI). The four treatment periods were separated by a washout period of 21 to 35 days.
886397|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
887855|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
886400|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886401|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886402|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886403|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886404|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886405|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886406|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886407|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886408|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886409|NCT01128595|O1|Outcome|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886410|NCT01128595|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886411|NCT01128595|O3|Outcome|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886412|NCT01128595|O2|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886413|NCT01128595|O1|Outcome|Placebo|
886414|NCT01128595|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886415|NCT01128595|E3|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886416|NCT01128595|E2|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886417|NCT01128595|E1|Reported Event|Placebo|Participants received placebo OD from the DPI for 21 days during one of the four treatment periods. Each treatment period was followed by a washout period of 21-35 days.
886418|NCT01128569|B1|Baseline|Placebo, FF 100 µg OD, FF/VI 100/25 µg OD in 1 of 6 Sequences|All participants received one of the following three treatments in one of three treatment periods once daily (OD) in the evening from the Dry Powder Inhaler (DPI) for 28 days: Placebo, Fluticasone Furoate (FF) 100 microgram (µg) dry inhalation powder, and FF/Vilanterol (FF/VI) 100/25 µg dry inhalation powder. Participants were randomized to receive treatment in one of the six following sequences: (1) Placebo, FF 100 µg, FF/VI 100/25 µg; (2) Placebo, FF/VI 100/25 µg, FF 100 µg; (3) FF 100 µg, FF/VI 100/25 µg, Placebo; (4) FF 100 µg, Placebo, FF/VI 100/25 µg; (5) FF/VI 100/25 µg, Placebo, FF 100 µg; (6) FF/VI 100/25 µg, FF 100 µg, Placebo. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886419|NCT01128569|P6|Participant Flow|Sequence 6: FF/VI 100/25 µg, FF 100 µg, Placebo|Participants received FF/VI 100/25 µg, FF 100 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886420|NCT01128569|P5|Participant Flow|Sequence 5: FF/VI 100/25 µg, Placebo, FF 100 µg|Participants received FF/VI 100/25 µg, placebo, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886421|NCT01128569|P4|Participant Flow|Sequence 4: FF 100 µg, Placebo, FF/VI 100/25 µg|Participants received FF 100 µg, placebo, and FF/VI 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886422|NCT01128569|P3|Participant Flow|Sequence 3: FF 100 µg, FF/VI 100/25 µg, Placebo|Participants received FF 100 µg, FF/VI 100/25 µg, and placebo in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886423|NCT01128569|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF 100 µg|Participants received placebo, FF/VI 100/25 µg, and FF 100 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day in the evening from a DPI for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886424|NCT01128569|P1|Participant Flow|Sequence 1: Placebo, FF 100 µg, FF/VI 100/25 µg|Participants received placebo, Fluticasone Furoate (FF) 100 micrograms (µg), and FF/Vilanterol (VI) 100/25 µg in Treatment Periods 1, 2, and 3, respectively. Participants received all treatments once a day (OD) in the evening from a Dry Powder Inhaler (DPI) for 28 days. The three treatment periods were separated by a washout period of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
892188|NCT01115673|E3|Reported Event|ACE-0|0 mg Acetaminophen Caplet
886425|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886426|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886427|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886428|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886429|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886430|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886431|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886432|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886433|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886434|NCT01128569|O3|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886435|NCT01128569|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886436|NCT01128569|O1|Outcome|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886437|NCT01128569|E3|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg dry inhalation powder OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886438|NCT01128569|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg dry inhalation powder OD in the evening from the DPI for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from Day 28 dose) and a maximum of 35 days.
886439|NCT01128569|E1|Reported Event|Placebo|Participants received Placebo OD from the DPI in the evening for 28 days during one of the three treatment periods. Each treatment period was followed by a washout of at least 21 days (from the Day 28 dose) and a maximum of 35 days.
886440|NCT01128543|B1|Baseline|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
886441|NCT01128543|P1|Participant Flow|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
886442|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
886443|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
886444|NCT01128543|O1|Outcome|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
886445|NCT01128543|E1|Reported Event|Lapatinib 1250 mg and Vinorelbine 20 mg/m^2|Participants received 1250 milligram (mg) tablets lapatinib once a day and vinorelbine 20 mg/meters squared (m^2) intravenously on Day 1 and Day 8, and every 3 weeks.
886446|NCT01128426|B1|Baseline|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886447|NCT01128426|P1|Participant Flow|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886543|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
886448|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886449|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886450|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886451|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886452|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886453|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886454|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886455|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886456|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 2 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886457|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886458|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886459|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886460|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886461|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886462|NCT01128426|O1|Outcome|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received first primary dose of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule.
886544|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
887856|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
886463|NCT01128426|E1|Reported Event|13vPnC|Participants enrolled in Kaiser Permanente Northern California (KPNC) health maintenance organization who received 3 primary doses of 13-valent pneumococcal conjugate vaccine (13vPnC, Prevnar 13 or Prevenar 13) within the first 6 months of life at approximately 2, 4, and 6 months of age, according to the Advisory Committee on Immunization Practices (ACIP)-recommended schedule. Participants may also have received fourth dose of 13vPnC according to the ACIP-recommended schedule. Participants were observed for 6 months follow up after Dose 3.
886464|NCT01128413|B3|Baseline|Total|Total of all reporting groups
886465|NCT01128413|B2|Baseline|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
886466|NCT01128413|B1|Baseline|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
886467|NCT01128413|P2|Participant Flow|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
886468|NCT01128413|P1|Participant Flow|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
886469|NCT01128413|O2|Outcome|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
886470|NCT01128413|O1|Outcome|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
886471|NCT01128413|E2|Reported Event|Routine Care (RC)|Patients randomized to receive routine ED care. IV fluid administration will be per the treating clinicians discretion.
886472|NCT01128413|E1|Reported Event|Fluid Optimization (FO)|Cheetah NICOM® (non-invasive cardiac output monitoring) Passive Leg Raise Testing (PLRT) that demonstrates a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) will receive a 500ml normal saline bolus. NICOM® PLRT with SVI or CI <15% will receive a saline lock.
886473|NCT01128400|B4|Baseline|Total|Total of all reporting groups
886474|NCT01128400|B3|Baseline|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
886475|NCT01128400|B2|Baseline|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
886476|NCT01128400|B1|Baseline|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
886477|NCT01128400|P3|Participant Flow|rs1761667-AG Genotype|Heterozygous of CD36 gene rs1761667-A genotype.
886478|NCT01128400|P2|Participant Flow|rs1761667-GG Genotype|subjects who are homozygous of CD36 genotype rs1761667-G allele.
886479|NCT01128400|P1|Participant Flow|rs1761667- AA Genotype|subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level and has a minor allele frequency of 38-48%.
886480|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
886481|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
886482|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
886483|NCT01128400|O3|Outcome|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
886484|NCT01128400|O2|Outcome|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
886485|NCT01128400|O1|Outcome|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
886486|NCT01128400|E3|Reported Event|rs1761667-AG Genotype|Obese subjects who are heterozygous of CD36 gene rs1761667-A genotype.
886487|NCT01128400|E2|Reported Event|rs1761667-GG Genotype|Obese subjects who are homozygous of CD36 genotype rs1761667-G allele.
886488|NCT01128400|E1|Reported Event|rs1761667- AA Genotype|Obese subjects carrying the CD36 genotype rs1761667, i.e. a Single Nucleotide Polymorphism that significantly reduces CD36 level
886489|NCT01128361|B3|Baseline|Total|Total of all reporting groups
886490|NCT01128361|B2|Baseline|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
886491|NCT01128361|B1|Baseline|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
886545|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886596|NCT01128114|B1|Baseline|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
886492|NCT01128361|P2|Participant Flow|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
886493|NCT01128361|P1|Participant Flow|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
886494|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
886495|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
886496|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
886497|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
886498|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
886499|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
886546|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886547|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886597|NCT01128114|P1|Participant Flow|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
886500|NCT01128361|O2|Outcome|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
886501|NCT01128361|O1|Outcome|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
886502|NCT01128361|E2|Reported Event|Stretching|Stretching: This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
886503|NCT01128361|E1|Reported Event|Aerobic Exercise|Aerobic Exercise: Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
886504|NCT01128270|B1|Baseline|All Subjects|Intent was to have all subjects participate in all sessions (periods)
886505|NCT01128270|P1|Participant Flow|All Subjects|The intent was to have all subjects participate in all four sessions (periods). These were environmental chloral hydrate +/- environmental DCA and therapeutic chloral hydrate +/- therapeutic DCA. Patient participation: 4 Sessions (N=2), 3 Sessions (N=1), 2 Sessions (N=6), 1 Session (N=8), 0 Sessions (N=10), Total: N=27 patients participated in 31 sessions.
886506|NCT01128270|O4|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
886507|NCT01128270|O3|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
886508|NCT01128270|O2|Outcome|Environmental Chloral Hydrate (1B)|Arm 1B: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights). Pharmacokinetics are done on days 1 and 5.
886509|NCT01128270|O1|Outcome|Environmental Chloral Hydrate and DCA (1A)|Arm 1A: Subjects are given Chloral Hydrate (1.5mcg/kg for five nights) and environmental Dichloroacetate on Day 1 (2.5 mcg/Kg.)pharmacokinetics are done on days 1 and 5.
886510|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
886511|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate (2B)|Arm 2B: Subjects are given Chloral Hydrate (25 mg/kg for five nights)(25 mg/Kg.) Pharmacokinetics are done on days 1 and 5.
886512|NCT01128270|O1|Outcome|Therapeutic Chloral Hydrate and DCA (2A)|Arm 2A: Subjects are given Chloral Hydrate (25 mg/kg for five nights) and therapeutic Dichloroacetate on Day 1 (25 mg/Kg.) Pharmacokinetics are done on days 1 and 5. This outcome only applies to Period 3.
886513|NCT01128270|E4|Reported Event|Chloral Hydrate (Therapeutic Dose)|This is Period 4 See description of periods for full details.
886514|NCT01128270|E3|Reported Event|Chloral Hydrate +DCA (Therapeutic Dose)|This is Period 3. See description of periods for full details.
886515|NCT01128270|E2|Reported Event|Chloral Hydrate (Environmental)|This is Period 2. See description of periods for full details.
886516|NCT01128270|E1|Reported Event|1A: Chloral Hydrate+DCA (Environmental)|This is Period 1. See description of periods for full details.
886517|NCT01128244|B1|Baseline|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
886548|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886549|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886642|NCT01127659|P2|Participant Flow|Diabetes With HH: Placebo|"placebo diabetes arm~placebo: saline intramuscular every 2 weeks"
886518|NCT01128244|P1|Participant Flow|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of the amino acids, serine, methionine and leucine: Subjects will be given an infusion of the amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
886519|NCT01128244|O1|Outcome|Secondary Analysis: Plasma 3-hydroxykynurenine Concentration|Plasma 3-hydroxykynurenine concentration will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
886520|NCT01128244|O1|Outcome|Plasma Cystathionine Concentration|Plasma cystathionine will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
886521|NCT01128244|O1|Outcome|Plasma Pyridoxal Phosphate Concentration|Plasma PLP will be measured for all subjects in fasting blood samples obtained at baseline and after 28 days of vitamin B6 supplementation. In addition, all subjects will have weekly weight, blood samples, and visits to the clinic to monitor compliance with the supplementation.
886522|NCT01128244|O1|Outcome|Homocysteine Remethylation Flux From Serine|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
886523|NCT01128244|O1|Outcome|Total Homocysteine Remethylation Flux|All subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation, and after 28-days of vitamin supplementation. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
886524|NCT01128244|E1|Reported Event|Vitamin B6 Effects in OC Users|"Subjects will be given an infusion of the amino acids serine and methionine prior to vitamin B6 supplementation and after 28 days of treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.~Vitamin B6: Subjects will receive vitamin B6 supplementation.~Infusion of amino acids, serine, and methionine: Subjects will be given an infusion of the amino acids, serine, and methionine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic."
886525|NCT01128192|B3|Baseline|Total|Total of all reporting groups
886526|NCT01128192|B2|Baseline|Pasireotide 900 μg sc Bid|Pasireotide 900 μg sc bid n=19
886527|NCT01128192|B1|Baseline|Pasireotide 600 μg sc Bid|Pasireotide 600 μg sc bid n=19
886528|NCT01128192|P3|Participant Flow|Pasireotide 1200 μg sc Bid|7 healthy male volunteers were randomized to receive Pasireotide 1200 μg (n=7). This arm was used in safety analysis only.
886529|NCT01128192|P2|Participant Flow|Pasireotide 900 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 900 μg (n=19). All participants completed the study.
886530|NCT01128192|P1|Participant Flow|Pasireotide 600 μg sc Bid|19 healthy male volunteers were randomized to receive Pasireotide 600 μg (n=19). All participants completed the study.
886531|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886532|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886533|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886534|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886535|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886536|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886537|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886538|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886539|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886540|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline Hyperinsulinemic-Euglycemic Clamp was conducted on Day 3 (pre-treatment) and post-treatment on Day 10.
886541|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
886542|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline hyperglycemic clamp test was conducted on Day 2 (pre-treatment) and a post-treatment hyperglycemic clamp was conducted on Day 9.
886593|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886550|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886551|NCT01128192|O2|Outcome|Pasireotide 900 µg sc Bid|Pasireotide 900 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886552|NCT01128192|O1|Outcome|Pasireotide 600 µg sc Bid|Pasireotide 600 µg was injected subcutaneously twice daily from Day 3-10. Baseline OGTT was conducted on Day 1 (pre-treatment) and a post-treatment OGTT was conducted on Day 8.
886553|NCT01128192|E3|Reported Event|Pasireotide 1200 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
886554|NCT01128192|E2|Reported Event|Pasireotide 900 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
886555|NCT01128192|E1|Reported Event|Pasireotide 600 μg sc Bid|Forty-five healthy male volunteers were randomized to receive pasireotide 600 μg (n=19), 900 μg (n=19) or 1200 μg (n=7) sc bid. All participants completed the study. Due to an increased severity of gastrointestinal AEs in the 1200 μg bid arm, randomization to this dose was discontinued after seven participants had completed the 7 days of treatment. These participants were included in the safety analyses only.
886556|NCT01128179|B3|Baseline|Total|Total of all reporting groups
886557|NCT01128179|B2|Baseline|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886558|NCT01128179|B1|Baseline|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886559|NCT01128179|P2|Participant Flow|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886560|NCT01128179|P1|Participant Flow|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886561|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886562|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886563|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886564|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886565|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886566|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886567|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886568|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886569|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886570|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886571|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886572|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886573|NCT01128179|O2|Outcome|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886574|NCT01128179|O1|Outcome|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886575|NCT01128179|E2|Reported Event|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
886576|NCT01128179|E1|Reported Event|Lanthanum Carbonate|1000 mg in chewable tablets (given as 2 x 500 mg tablets) administered three times a day (for a total of 3000 mg/day) for 12 weeks
886577|NCT01128153|B3|Baseline|Total|Total of all reporting groups
886578|NCT01128153|B2|Baseline|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886579|NCT01128153|B1|Baseline|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886580|NCT01128153|P2|Participant Flow|PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886581|NCT01128153|P1|Participant Flow|SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886582|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886583|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886584|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886585|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886586|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886587|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886588|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886589|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886590|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886591|NCT01128153|O1|Outcome|Arm 1 - SAXAGLIPTIN|Saxagliptin 5 mg tablet once daily for 24 weeks to be taken orally
886592|NCT01128153|O2|Outcome|Arm 2 - PLACEBO|Placebo tablet once daily for 24 weeks to be taken orally
886598|NCT01128114|O1|Outcome|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
886599|NCT01128114|E1|Reported Event|Quetiapine XR|Extended Release (XR) 50mg, 200mg 300mg and/or 400mg tablet, oral once daily in the evening, from assignment to the end of the study
886600|NCT01128049|B4|Baseline|Total|Total of all reporting groups
886601|NCT01128049|B3|Baseline|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
886602|NCT01128049|B2|Baseline|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
886603|NCT01128049|B1|Baseline|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
886604|NCT01128049|P3|Participant Flow|ADDE Population|Subjects with schirmer’s value < 10mm/5 mins and no meibomian gland dysfunction.
886605|NCT01128049|P2|Participant Flow|MGD Patient Population|Subjects with a meibomian gland dysfunction on a slitlamp examination with a fluorescein tear break-up time <5 secs.
886606|NCT01128049|P1|Participant Flow|Normal Patient Population|Subjects with no symptoms and no diagnosis of dry eye. Schirmer’s value ≥ 10mm/5 mins and a fluorescein tear break-up time >5 secs with no surface staining.
886607|NCT01128049|O3|Outcome|Aqueous Deficiency Dry Eye (ADDE)|Subjects with a low tear volume measured by Schimer's score of less than 10 mm were included in this group.
886608|NCT01128049|O2|Outcome|Meibomian Gland Dysfunction (MGD)|Subjects with mild to moderate Meibomian Gland Dysfunction (MGD) on a slit lamp examination were included in this group.
886609|NCT01128049|O1|Outcome|Normal|Normal group included non-dry eye subjects.
886610|NCT01128049|E3|Reported Event|ADDE Population|Aqueous Deficient Dry Eye population(intervention remains the same across all arms)
886611|NCT01128049|E2|Reported Event|MGD Patient Population|Meibomium Gland Dysfunction population(intervention remains the same across all arms)
886612|NCT01128049|E1|Reported Event|Normal Patient Population|Non-Dry Eye patient population (intervention remains the same across all arms)
886613|NCT01127763|B1|Baseline|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
886614|NCT01127763|P1|Participant Flow|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
886615|NCT01127763|O1|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
886616|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.~RAD001~Carboplatin"
886617|NCT01127763|O3|Outcome|RAD001+Carboplatin (All Patients)|Carboplatin every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
886618|NCT01127763|O2|Outcome|RAD001+Carboplatin (AUC 4)|Carboplatin (starting dose of AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
886619|NCT01127763|O1|Outcome|RAD001+Carboplatin (AUC 6 and 5)|Carboplatin (starting dose of AUC 6 or AUC 5) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day.
886620|NCT01127763|O1|Outcome|RAD001+Carboplatin|"Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.~RAD001~Carboplatin"
886621|NCT01127763|E1|Reported Event|RAD001+Carboplatin|Carboplatin (starting dose was initially AUC 6, later decreased to AUC 5, then AUC 4) every 3 weeks as IV infusion and RAD001 as 5 mg pill each day until disease progression or unacceptable toxicity.
886622|NCT01127737|B3|Baseline|Total|Total of all reporting groups
886623|NCT01127737|B2|Baseline|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
886624|NCT01127737|B1|Baseline|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
886625|NCT01127737|P2|Participant Flow|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
886626|NCT01127737|P1|Participant Flow|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
886627|NCT01127737|O2|Outcome|Placebo|
886628|NCT01127737|O1|Outcome|Intervention|Educational intervention consisting of a mnemonic and a workboook
886629|NCT01127737|E2|Reported Event|Intervention|Educational intervention consisting of a mnemonic and a workbook used by kidney transplant recipients (KTRs) to assist with early detection of SCCs.
886630|NCT01127737|E1|Reported Event|Control|Control group received only intiial assessment at the time of physician visit and education as usually provided during the physician visit.
886631|NCT01127659|B7|Baseline|Total|Total of all reporting groups
886632|NCT01127659|B6|Baseline|Eugonadal Obese|obese non-diabetic men with normal testosterone
886633|NCT01127659|B5|Baseline|Eugonadal Diabetes|diabetic men with normal testosterone
886634|NCT01127659|B4|Baseline|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
886635|NCT01127659|B3|Baseline|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
886636|NCT01127659|B2|Baseline|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
886637|NCT01127659|B1|Baseline|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks"
886638|NCT01127659|P6|Participant Flow|Eugonadal Obese|no intervention
886639|NCT01127659|P5|Participant Flow|Eugonadal Diabetes|no intervention
886640|NCT01127659|P4|Participant Flow|Obese Placebo|"placebo obese arm~placebo: saline intramuscular every 2 weeks"
886641|NCT01127659|P3|Participant Flow|Obese Testosterone|"active drug obese arm~testosterone: intramuscular every 2 weeks"
886646|NCT01127659|O4|Outcome|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
886647|NCT01127659|O3|Outcome|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
886648|NCT01127659|O2|Outcome|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
886649|NCT01127659|O1|Outcome|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks~Glucose infusion rate: 6.5+/-4.0 mg/kg fat-free mass/min"
886650|NCT01127659|E6|Reported Event|Eugonadal Obese|obese non-diabetic men with normal testosterone
886651|NCT01127659|E5|Reported Event|Eugonadal Diabetes|diabetic men with normal testosterone
886652|NCT01127659|E4|Reported Event|Obese With HH: Placebo|"placebo obese hypogonadal arm~placebo: saline intramuscular every 2 weeks"
886653|NCT01127659|E3|Reported Event|Obese With HH: Testosterone|"active drug obese hypogonadal arm~testosterone: intramuscular every 2 weeks"
886654|NCT01127659|E2|Reported Event|Diabetes With HH: Placebo|"placebo diabetes hypogonadal arm~placebo: saline intramuscular every 2 weeks"
886655|NCT01127659|E1|Reported Event|Diabetes With HH: Testosterone|"active drug diabetes hypogonadal arm~testosterone: intramuscular every 2 weeks"
886656|NCT01127646|B3|Baseline|Total|Total of all reporting groups
886657|NCT01127646|B2|Baseline|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886658|NCT01127646|B1|Baseline|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886659|NCT01127646|P2|Participant Flow|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886660|NCT01127646|P1|Participant Flow|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886661|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
886662|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
886663|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
886664|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
886665|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886666|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886667|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886668|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886669|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886670|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886715|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886716|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886671|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886672|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886673|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886674|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886675|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
886676|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
886677|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886678|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886679|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886680|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886681|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886682|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886683|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886684|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886685|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886686|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886687|NCT01127646|O2|Outcome|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886688|NCT01127646|O1|Outcome|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily for 4 weeks (on/off period), except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period.
886689|NCT01127646|E2|Reported Event|Osmotic-Release Oral System (OROS) Methylphenidate|Participants received 18-54 mg of OROS methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
886690|NCT01127646|E1|Reported Event|Atomoxetine|Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days.
886691|NCT01127607|B3|Baseline|Total|Total of all reporting groups
886692|NCT01127607|B2|Baseline|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
886693|NCT01127607|B1|Baseline|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
886694|NCT01127607|P2|Participant Flow|Treatment Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period I). The 13 subjects assigned to this arm were then switched to blinded optimal dose of LDX for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only their optimal dose of LDX during period II.
886695|NCT01127607|P1|Participant Flow|Placebo Arm|All 27 Participants were first optimized on lisdexamfetamine (LDX) (30mg, 50mg or 70mg) over 3 weeks then underwent within-subjects comparison with each subject completed one parent child interaction task (DPICS) once on optimal LDX dose and one parent child interaction task once on placebo (Period 1). The 14 subjects assigned to this arm were then switched to blinded placebo for the parallel group, between subjects trial (period II) which lasted until the final endpoint assessment. These subjects received only placebo during period II.
886696|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
886697|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
886698|NCT01127607|O4|Outcome|70 mg Lisdexamfetamine|This group includes all participants who were prescribed the 70mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg and 50mg doses and are therefore included in those groups as well. Not all participants who were prescribed this dose were optimized to this dose.
886699|NCT01127607|O3|Outcome|50 mg Lisdexamfetamine|This group includes all participants who were prescribed the 50mg dose and completed at least one side effect rating for this dose. All participants reaching this dose were also treated with the 30mg dose and are therefore included in that group as well.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study.
886700|NCT01127607|O2|Outcome|30 mg Lisdexamfetamine|This arm includes all participants who were prescribed the 30mg dose and completed at least one side effect rating for this dose.Not all participants who were prescribed this dose were optimized to this dose or went on to enter the randomized phase of the study which is why this cell size is larger than for the randomized controlled comparison that followed it.
886701|NCT01127607|O1|Outcome|No Medication|The PSERS was completed at intake by all 38 participants who consented and met eligibility criteria in order to assess pre-medication rates of side effects. This was done because the PSERS measures commonly occurring events such as insomnia and irritability that can be seen in unmedicated patients with ADHD.
886702|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886703|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886704|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886705|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886706|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886707|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886708|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886709|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886710|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886711|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886712|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886713|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886714|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886717|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886718|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886719|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886720|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886721|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886722|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
886723|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
886724|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886725|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886726|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886727|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886728|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886729|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886730|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886731|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886732|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
886733|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
886734|NCT01127607|O2|Outcome|Treatment Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded matching doses of lisdexamfetamine for 4 weeks of the parallel group trial.
886735|NCT01127607|O1|Outcome|Placebo Arm|Participants in this arm were first optimized on lisdexamfetamine (30mg, 50mg or 70mg) over 3 weeks then switched to blinded placebo for the 4 weeks of the parallel group trial
886736|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886737|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886738|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886739|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886740|NCT01127607|O2|Outcome|Treatment Arm|participants in this arm treated with blinded optimal dose of LDX for 4 weeks (either 30mg, 50mg or 70mg)
886741|NCT01127607|O1|Outcome|Placebo Arm|participants in this arm treated with matching placebo for 4 weeks duration
886742|NCT01127607|O2|Outcome|Optimal Dose of Medication|Optimal dose of lisdexamfetamine (30 mg, 50 mg, or 70 mg) as selected by a three week open medication titration trial.
886743|NCT01127607|O1|Outcome|Unmedicated|baseline; participants not on medication
886744|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886745|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886746|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886747|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886748|NCT01127607|O4|Outcome|Medication Non-academic Task|Parent-child interaction during a non-academic task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886749|NCT01127607|O3|Outcome|Medication - Homework Task|Parent-child interaction during a homework task. Parents were on their optimal dose of lisdexamfetamine (30, 50, or 70 mg) and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886750|NCT01127607|O2|Outcome|Placebo - Non-academic Task|Parent-child interaction during a non-academic task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886751|NCT01127607|O1|Outcome|Placebo - Homework Task|Parent-child interaction during a homework task. Parents were on placebo and children were unmedicated. Parents and children did not have knowledge of parent treatment condition (medication versus placebo)
886752|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
886753|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
886754|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
886755|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
886756|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
886757|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
886758|NCT01127607|O2|Outcome|Optimal Dose of Medication|Data collected after participants received 1 to 3 weeks of their optimal dose of LDX (either 30mg, 50mg or 70mg)
886759|NCT01127607|O1|Outcome|Unmedicated|Data collected at intake, when participants were not on medication
886760|NCT01127607|E5|Reported Event|All Participants in Period 1 Prescribed 70mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~17 of 36 participants were dispensed the 70mg dose."
886761|NCT01127607|E4|Reported Event|All Participants in Period 1 Prescribed 50mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~21 of 36 participants were dispensed the 50mg dose."
886762|NCT01127607|E3|Reported Event|All Participants in Period 1 Prescribed 30mg|"During the dose optimization period which occurred before assignment to the placebo arm or treatment arm, all participants were treated with open label medication starting at 30mg of lisdexamfetamine (LDX). Dose was increased weekly (to a max of 70mg) until the optimal dose was defined. Once optimal dose criteria was met, the titration was stopped. Most participants received multiple doses so results for each dose are presented rather than for each participant.~All 36 participants who were dispensed the 30mg dose and completed at least one Pittsburgh Side Effect Rating Scale (PSERS) are included in this category."
886763|NCT01127607|E2|Reported Event|Treatment Arm|subjects in this arm (N=13) only treated with blinded optimal dose of LDX (either 30mg, 50mg or 70mg) for duration of assessment (period II between subjects trial).
886764|NCT01127607|E1|Reported Event|Placebo Arm|subjects in this arm treated only with blinded placebo for duration of assessment (period II- between subjects trial).One participant assigned to placebo dropped out before medication was dispensed for period II which is why the side effect data only has a total of 13 and not 14 subjects.
886765|NCT01127581|B3|Baseline|Total|Total of all reporting groups
886766|NCT01127581|B2|Baseline|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886767|NCT01127581|B1|Baseline|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886768|NCT01127581|P2|Participant Flow|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886769|NCT01127581|P1|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886770|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886771|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886772|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886773|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886774|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886845|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
886775|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886776|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886777|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886778|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886779|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886780|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886781|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886782|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886783|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886784|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886785|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886786|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886787|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886788|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886789|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886790|NCT01127581|O2|Outcome|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886846|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
886847|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
886791|NCT01127581|O1|Outcome|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886792|NCT01127581|E2|Reported Event|Dinoprostone Vaginal Insert (DVI)|"10 mg Dinoprostone vaginal insert~Dinoprostone vaginal insert: Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886793|NCT01127581|E1|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~MVI 200: Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
886794|NCT01127438|B7|Baseline|Total|Total of all reporting groups
886795|NCT01127438|B6|Baseline|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886796|NCT01127438|B5|Baseline|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886797|NCT01127438|B4|Baseline|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886798|NCT01127438|B3|Baseline|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886799|NCT01127438|B2|Baseline|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886800|NCT01127438|B1|Baseline|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886801|NCT01127438|P6|Participant Flow|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
886802|NCT01127438|P5|Participant Flow|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 3.9mg of Lusedra per kg during the Randomization Phase (1 day).
886803|NCT01127438|P4|Participant Flow|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomization Phase (1 day).
886804|NCT01127438|P3|Participant Flow|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiologists (ASA) physical classification status 3 or 4. The doses were weight-adjusted for each subject, with 4.875mg of Lusedra per kg during the Randomization Phase (1 day).
886805|NCT01127438|P2|Participant Flow|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomization Phase (1 day).
886806|NCT01127438|P1|Participant Flow|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiologists (ASA) physical classification status 1 or 2. The doses were weight-adjusted for each subject, with 6.5mg of Lusedra per kg during the Randomization Phase (1 day).
886807|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886808|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886809|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886810|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886811|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886812|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886813|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886814|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886815|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886816|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886817|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886818|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886819|NCT01127438|O6|Outcome|Subgroup 3, Approved Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886820|NCT01127438|O5|Outcome|Subgroup 3, Lower Dose|This arm consisted of subjects with a weight at or above 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 3.9mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886821|NCT01127438|O4|Outcome|Subgroup 2, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. A dose of 297.5mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886822|NCT01127438|O3|Outcome|Subgroup 2, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 65 years, and/or an American Society of Anesthesiolog ists (ASA) physical classification status 3 or 4. The doses were weightadjusted for each subject, with 4.875mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886823|NCT01127438|O2|Outcome|Subgroup 1, Approved Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. A dose of 385mg of Lusedra was taken during the Randomizatio n Phase (1 day).
886824|NCT01127438|O1|Outcome|Subgroup 1, Lower Dose|This arm consisted of subjects with a weight below 60kg, an age at or greater than 18 years but below 65 years, and an American Society of Anesthesiolog ists (ASA) physical classification status 1 or 2. The doses were weightadjusted for each subject, with 6.5mg of Lusedra per kg during the Randomizatio n Phase (1 day).
886825|NCT01127438|E2|Reported Event|Approved Dose|Includes subgroups 1-3
886826|NCT01127438|E1|Reported Event|Lower Dose|Includes subgroups 1-3
886827|NCT01127321|B6|Baseline|Total|Total of all reporting groups
886828|NCT01127321|B5|Baseline|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
886829|NCT01127321|B4|Baseline|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
886830|NCT01127321|B3|Baseline|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
886831|NCT01127321|B2|Baseline|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
886832|NCT01127321|B1|Baseline|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
886833|NCT01127321|P5|Participant Flow|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
886834|NCT01127321|P4|Participant Flow|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
886835|NCT01127321|P3|Participant Flow|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
886836|NCT01127321|P2|Participant Flow|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
886837|NCT01127321|P1|Participant Flow|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
886838|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
886839|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
886840|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
886841|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
886842|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
886843|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
886844|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
887857|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
886848|NCT01127321|O5|Outcome|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
886849|NCT01127321|O4|Outcome|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
886850|NCT01127321|O3|Outcome|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
886851|NCT01127321|O2|Outcome|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
886852|NCT01127321|O1|Outcome|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
886853|NCT01127321|E5|Reported Event|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
886854|NCT01127321|E4|Reported Event|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
886855|NCT01127321|E3|Reported Event|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
886856|NCT01127321|E2|Reported Event|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
886857|NCT01127321|E1|Reported Event|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
886858|NCT01127256|B3|Baseline|Total|Total of all reporting groups
886859|NCT01127256|B2|Baseline|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
886860|NCT01127256|B1|Baseline|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
886861|NCT01127256|P2|Participant Flow|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
886862|NCT01127256|P1|Participant Flow|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
886863|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
886864|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
886865|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
886866|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
886867|NCT01127256|O2|Outcome|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
886868|NCT01127256|O1|Outcome|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
886869|NCT01127256|E2|Reported Event|Carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
886870|NCT01127256|E1|Reported Event|Zonisamide|Initial dose was 100 mg/day, increased by 100 mg. The maximum dose was 600 mg/day.
886871|NCT01127165|B3|Baseline|Total|Total of all reporting groups
886872|NCT01127165|B2|Baseline|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
886873|NCT01127165|B1|Baseline|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
886874|NCT01127165|P2|Participant Flow|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
886875|NCT01127165|P1|Participant Flow|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
886876|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
886877|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
886878|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
886879|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
886880|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
886881|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
886882|NCT01127165|O2|Outcome|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
886883|NCT01127165|O1|Outcome|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
886884|NCT01127165|E2|Reported Event|Zonisamide High Dose Group|Initial dose was 2 mg/kg/day, increased after 2~4 weeks to 6~8 mg/kg/day.
886885|NCT01127165|E1|Reported Event|Zonisamide Low Dose Group|Initial dose was 2 mg/kg/day, increased after 1~2 weeks to 3~4 mg/kg/day.
886886|NCT01127139|B1|Baseline|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886887|NCT01127139|P1|Participant Flow|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886888|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886889|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886890|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
886891|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
886892|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
886952|NCT01126619|O2|Outcome|Week 24|Week 24 Static Physician Global Assessment of Psoriasis, after 24 weeks of anti-TNF therapy.
886893|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886894|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886895|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886896|NCT01127139|O1|Outcome|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886897|NCT01127139|O3|Outcome|Male Participants|Male Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
886898|NCT01127139|O2|Outcome|Female Participants|Female Czech hypertensive patients with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
886899|NCT01127139|O1|Outcome|Total|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg treated with fixed-combination Tarka®.
886900|NCT01127139|E1|Reported Event|Czech Patients With Essential Hypertension|Czech hypertensive patients (women and men) with systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg who can be treated with fixed-combination Tarka®.
886901|NCT01127087|B3|Baseline|Total|Total of all reporting groups
886902|NCT01127087|B2|Baseline|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886903|NCT01127087|B1|Baseline|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886904|NCT01127087|P2|Participant Flow|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886905|NCT01127087|P1|Participant Flow|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886906|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886907|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units oxalate decarboxylase (OxDC) in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886908|NCT01127087|O2|Outcome|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886909|NCT01127087|O1|Outcome|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886910|NCT01127087|E2|Reported Event|Idiopathic Hyperoxaluria CaOx Stone Formers|"Subjects with idiopathic hyperoxaluria.~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886911|NCT01127087|E1|Reported Event|RYGB CaOx Stone Formers|"Subjects with enteric hyperoxaluria after Roux-en-Y Gastric Bypass (RYGB).~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
886912|NCT01126957|B1|Baseline|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
886913|NCT01126957|P1|Participant Flow|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine or placebo infusion, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
886953|NCT01126619|O1|Outcome|Baseline|Baseline Static Physician Global Assessment of Psoriasis, prior to initiation of anti-TNF therapy.
892189|NCT01115673|E2|Reported Event|ACE-650|650 mg Acetaminophen Caplet
886914|NCT01126957|O1|Outcome|Ketamine|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
886915|NCT01126957|O1|Outcome|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or placebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
886916|NCT01126957|E1|Reported Event|Ketamine or Placebo|"Participants received 0.5-1.5 micrograms/kg Fentanyl, followed 0.5 mg/kg Ketamine infusion or palcebo, followed by propofol to maintain sedation.~Ketamine: Ketamine was given as a 0.5mg / Kg bolus.~Fentanyl: Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo~Propofol: Propofol given to both arms to maintain sedation throughout procedure."
886917|NCT01126801|B3|Baseline|Total|Total of all reporting groups
886918|NCT01126801|B2|Baseline|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
886919|NCT01126801|B1|Baseline|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
886920|NCT01126801|P2|Participant Flow|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
886921|NCT01126801|P1|Participant Flow|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
886922|NCT01126801|O2|Outcome|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
886923|NCT01126801|O1|Outcome|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
886924|NCT01126801|E2|Reported Event|Placebo|Placebo control: Placebo control matched to estradiol tablets. Daily dosing for one month.
886925|NCT01126801|E1|Reported Event|Estradiol|Estradiol: Oral estradiol 1.0 mg/day for four weeks.
886926|NCT01126723|B3|Baseline|Total|Total of all reporting groups
886927|NCT01126723|B2|Baseline|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
886928|NCT01126723|B1|Baseline|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
886929|NCT01126723|P2|Participant Flow|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
886930|NCT01126723|P1|Participant Flow|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
886931|NCT01126723|O2|Outcome|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
886932|NCT01126723|O1|Outcome|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
886933|NCT01126723|E2|Reported Event|Educational Control Group|Education-Control: The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
886934|NCT01126723|E1|Reported Event|Tai Chi Group|Tai Chi: The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
886935|NCT01126671|B3|Baseline|Total|Total of all reporting groups
886936|NCT01126671|B2|Baseline|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
886937|NCT01126671|B1|Baseline|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
886938|NCT01126671|P2|Participant Flow|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
886939|NCT01126671|P1|Participant Flow|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
886940|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
886941|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
886942|NCT01126671|O2|Outcome|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
886943|NCT01126671|O1|Outcome|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
886944|NCT01126671|E2|Reported Event|High Dose Vitamin D|Subjects in this arm of the study took 1000 IU vit D3 daily.
886945|NCT01126671|E1|Reported Event|Low Dose Vitamin D|Subjects in this arm of the study took 200 IU vit D3 daily.
886946|NCT01126619|B1|Baseline|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886947|NCT01126619|P1|Participant Flow|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886948|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886949|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886950|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886951|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
887154|NCT01126437|B4|Baseline|Total|Total of all reporting groups
886954|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886955|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886956|NCT01126619|O1|Outcome|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886957|NCT01126619|E1|Reported Event|Anti-TNF|Participants with moderate to severe psoriasis who were prescribed an Anti Tumor Necrosis Factor (anti-TNF) agent prior to enrollment according to national approved indications and reimbursement guidelines.
886958|NCT01126593|B4|Baseline|Total|Total of all reporting groups
886959|NCT01126593|B3|Baseline|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
886960|NCT01126593|B2|Baseline|Control Group|The control group patients will receive no continuous infusion catheter.
886961|NCT01126593|B1|Baseline|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
886962|NCT01126593|P3|Participant Flow|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
886963|NCT01126593|P2|Participant Flow|Control Group|The control group patients will receive no continuous infusion catheter.
886964|NCT01126593|P1|Participant Flow|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
886965|NCT01126593|O3|Outcome|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
886966|NCT01126593|O2|Outcome|Control Group|The control group patients will receive no continuous infusion catheter.
886967|NCT01126593|O1|Outcome|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
886968|NCT01126593|E3|Reported Event|Study Group|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.
886969|NCT01126593|E2|Reported Event|Control Group|The control group patients will receive no continuous infusion catheter.
886970|NCT01126593|E1|Reported Event|Placebo Group|The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.
886971|NCT01126580|B4|Baseline|Total|Total of all reporting groups
886972|NCT01126580|B3|Baseline|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886973|NCT01126580|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886974|NCT01126580|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886975|NCT01126580|P3|Participant Flow|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886976|NCT01126580|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886977|NCT01126580|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886978|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886979|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886980|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886981|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886982|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886983|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886984|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886985|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886986|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886987|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886988|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886989|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886990|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886991|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886992|NCT01126580|O1|Outcome|1.5 mg or 0.75 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886993|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886994|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886995|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886996|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
886997|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886998|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
886999|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887000|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887001|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887002|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887003|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887004|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887005|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887006|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887007|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887008|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887009|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887010|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887011|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887012|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887013|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887014|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887015|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887016|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887017|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887018|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887019|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887020|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887021|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887022|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887023|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887024|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887025|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887026|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887027|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
892190|NCT01115673|E1|Reported Event|ACE-1000|1000 mg Acetaminophen Caplet
887028|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887029|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887030|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887031|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887032|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887033|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887034|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887035|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887036|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887037|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887038|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887039|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887040|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887041|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887042|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887043|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887044|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887045|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887046|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887047|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887048|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887049|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887050|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887051|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887052|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887053|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887054|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887055|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887056|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887057|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887058|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887059|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887060|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887061|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887062|NCT01126580|O3|Outcome|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887063|NCT01126580|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887064|NCT01126580|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887858|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
887065|NCT01126580|E3|Reported Event|Metformin|"Metformin: 2000 milligrams per day (mg/day) or at least 1500 mg/day, orally, for 52 weeks~Placebo: subcutaneously (SC), once weekly for 52 weeks"
887066|NCT01126580|E2|Reported Event|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887067|NCT01126580|E1|Reported Event|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneously (SC), once weekly for 52 weeks~Placebo: orally, twice daily for 52 weeks"
887068|NCT01126541|B4|Baseline|Total|Total of all reporting groups
887069|NCT01126541|B3|Baseline|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
887070|NCT01126541|B2|Baseline|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887071|NCT01126541|B1|Baseline|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887072|NCT01126541|P3|Participant Flow|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
887073|NCT01126541|P2|Participant Flow|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887074|NCT01126541|P1|Participant Flow|Randomized Retreatment Arm A: Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) on Days 1 and 15. After Week 24, if Disease Activity Score based on 28-Joint Count (DAS28) was greater than (>)3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and methotrexate (MTX) ≥10 milligrams per week (mg/week) by mouth or parenteral throughout course of treatment.
887075|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887076|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887077|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887078|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887079|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887080|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887081|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887082|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887083|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887084|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887155|NCT01126437|B3|Baseline|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887085|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887086|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887087|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887088|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887089|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887090|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887091|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887092|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887093|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887094|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887095|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887096|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887097|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887098|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887099|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887100|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887101|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887156|NCT01126437|B2|Baseline|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887859|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
887102|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887103|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887104|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887105|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887106|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887107|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887108|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887109|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887110|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887111|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887112|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887113|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887114|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887115|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887116|NCT01126541|O1|Outcome|Randomized Re-treatment Arm A: Single 1000 mg IV Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887117|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887118|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887157|NCT01126437|B1|Baseline|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887860|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
887119|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887120|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887121|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887122|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887123|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887124|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887125|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
887126|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887127|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887128|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887129|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887130|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887131|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887132|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887133|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887134|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887135|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887158|NCT01126437|P3|Participant Flow|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887238|NCT01126268|B1|Baseline|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887136|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887137|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887138|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887139|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887140|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887141|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887142|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887143|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887144|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887145|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887146|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887147|NCT01126541|O2|Outcome|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887148|NCT01126541|O1|Outcome|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887149|NCT01126541|O2|Outcome|Nonrandomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
887150|NCT01126541|O1|Outcome|Randomized Group|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants were randomized to receive a single rituximab 1000 mg IV infusion (Retreatment Arm A) or 2 x rituximab 1000 mg IV infusions 15 days apart (Retreatment Arm B). All participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887151|NCT01126541|E3|Reported Event|Nonrandomized: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15, methylprednisolone 100 mg IV at 30 minutes before each rituximab infusion, and MTX ≥10 mg/week by mouth or parenterally throughout treatment course.
887152|NCT01126541|E2|Reported Event|Randomized Retreatment Arm B: Rituximab 1000 mg x 2|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received two additional infusions of rituximab 1000 mg IV, 15 days apart. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and ≥10 mg/week MTX by mouth or parenteral throughout course of treatment.
887153|NCT01126541|E1|Reported Event|Randomized Retreatment Arm A: Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15. After Week 24, if DAS28 was >3.2, participants received one additional infusion of rituximab 1000 mg IV. Participants received methylprednisolone 100 mg IV 30 minutes before each rituximab infusion and MTX ≥10 mg/week by mouth or parenteral throughout course of treatment.
887159|NCT01126437|P2|Participant Flow|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887160|NCT01126437|P1|Participant Flow|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887161|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887162|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887163|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887164|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887165|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887166|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887167|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887168|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887169|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887170|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887171|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887172|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887173|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887174|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887175|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887176|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887177|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887178|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887179|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887180|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887181|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887182|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887183|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887184|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887185|NCT01126437|O3|Outcome|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 18 mcg: HandiHaler"
887186|NCT01126437|O2|Outcome|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887187|NCT01126437|O1|Outcome|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887188|NCT01126437|E3|Reported Event|Tiotropium 18 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~Tiotropium 18 mcg: HandiHaler"
887189|NCT01126437|E2|Reported Event|Tiotropium 5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 2.5 mcg (2 actuations/day): soft mist inhaler (2 actuations=2 puffs/day)"
887190|NCT01126437|E1|Reported Event|Tiotropium 2.5 mcg and Placebo|"Patients receive one of the active tiotropium arms daily~tiotropium 1.25 mcg (2 actuations/day): soft mist inhaler 2 actuations=2 puffs/day"
887191|NCT01126424|B7|Baseline|Total|Total of all reporting groups
887192|NCT01126424|B6|Baseline|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
887193|NCT01126424|B5|Baseline|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
887194|NCT01126424|B4|Baseline|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
887195|NCT01126424|B3|Baseline|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
887196|NCT01126424|B2|Baseline|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
887197|NCT01126424|B1|Baseline|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
887198|NCT01126424|P6|Participant Flow|Placebo / Oxybutynin / Solifenacin|Participants received 21 days of each treatment in the following order: placebo, 10 mg oxybutynin, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
887199|NCT01126424|P5|Participant Flow|Placebo / Solifenacin / Oxybutynin|Participants received 21 days of each treatment in the following order: placebo, 5 mg solifenacin, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
887200|NCT01126424|P4|Participant Flow|Oxybutynin / Solifenacin / Placebo|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, 5 mg solifenacin, placebo. There was a 21-day washout period between each treatment period.
887201|NCT01126424|P3|Participant Flow|Oxybutynin / Placebo / Solifenacin|Participants received 21 days of each treatment in the following order: 10 mg oxybutynin, placebo, 5 mg solifenacin. There was a 21-day washout period between each treatment period.
887202|NCT01126424|P2|Participant Flow|Solifenacin / Placebo / Oxybutynin|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, placebo, 10 mg oxybutynin. There was a 21-day washout period between each treatment period.
887203|NCT01126424|P1|Participant Flow|Solifenacin / Oxybutynin / Placebo|Participants received 21 days of each treatment in the following order: 5 mg solifenacin, 10 mg oxybutynin, placebo. There was a 21-day washout period between each treatment period.
887204|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
887205|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
887206|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
887207|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
887208|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
887209|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
887210|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
887211|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
887212|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
887213|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
887214|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
887215|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
887216|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
887217|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
887218|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
887219|NCT01126424|O3|Outcome|Placebo|Participants received 21 days of treatment with placebo.
887220|NCT01126424|O2|Outcome|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
887221|NCT01126424|O1|Outcome|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
887222|NCT01126424|E3|Reported Event|Placebo|Participants received 21 days of treatment with placebo.
887223|NCT01126424|E2|Reported Event|Oxybutynin|Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form.
887224|NCT01126424|E1|Reported Event|Solifenacin|Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day.
887225|NCT01126359|B1|Baseline|All Study Participants|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa.
887226|NCT01126359|P2|Participant Flow|Placebo-Saline Then Lidocaine|Control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube. Then, interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
887227|NCT01126359|P1|Participant Flow|Lidocaine Then Placebo-Saline|Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge. Then, control dressing change: iv or po pain medication and injection of 1% saline retrograde up the suction tube.
887228|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Each patient narcotic requirements are determined at each measured time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline difference (mg). A negative narcotic requirement difference indicates a reduction in medication dosed (mg) used during and after VAC dressing change in a crossover intervention technique.
887229|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
887230|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
887231|NCT01126359|O3|Outcome|Lidocaine Minus Placebo-Saline Difference|Includes participants randomized to receive Lidocaine first, then Placebo-Saline; and vice versa. Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal) as the Lidocaine minus Placebo-Saline VAS difference for each participant. A negative VAS difference indicates a reduction in the level of pain with Lidocaine compared to Placebo-Saline utilizing crossover intervention.
887232|NCT01126359|O2|Outcome|Placebo-Saline|All patients who received placebo-saline prior to VAC dressing change.
887233|NCT01126359|O1|Outcome|Lidocaine|All patients who received lidocaine prior to VAC dressing change.
887239|NCT01126268|P1|Participant Flow|Retapamulin Ointment 1% Group|Subjects with clinically diagnosed with impetigo, folliculitis, or minor soft tissue infection suitable for treatment with a topical antibiotic were screened, and if qualified, they received topical retapamulin ointment 1% twice daily for 5 days.
887240|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887241|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887242|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887243|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887244|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887245|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887246|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887247|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887248|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887249|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887250|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887251|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887252|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887253|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887254|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887255|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887256|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887257|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887258|NCT01126268|O1|Outcome|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887259|NCT01126268|E1|Reported Event|Retapamulin Ointment 1%|Retapamulin (Altabax): Retapamulin ointment, applied topically twice daily for five days
887260|NCT01126099|B3|Baseline|Total|Total of all reporting groups
887261|NCT01126099|B2|Baseline|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
887262|NCT01126099|B1|Baseline|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
887263|NCT01126099|P2|Participant Flow|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
887264|NCT01126099|P1|Participant Flow|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
887265|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
887266|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
887267|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
887268|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
887269|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
887270|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
887271|NCT01126099|O2|Outcome|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
887272|NCT01126099|O1|Outcome|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
887273|NCT01126099|E2|Reported Event|Placebo|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Placebo: Placebo capsules twice daily for 12 weeks"
887274|NCT01126099|E1|Reported Event|Prazosin|"In the double blind phase (12 weeks), study participants will take either prazosin for placebo. For the open label phase (12 weeks), all study participants will take prazosin.~Prazosin: 4 mg capsules twice daily for 12 weeks"
887277|NCT01126060|B1|Baseline|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
887278|NCT01126060|P2|Participant Flow|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
887279|NCT01126060|P1|Participant Flow|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
887280|NCT01126060|O2|Outcome|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
887281|NCT01126060|O1|Outcome|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
887282|NCT01126060|E2|Reported Event|No Fibrin Sealant|No usage of fibrin sealant No usage of alternative drugs
887283|NCT01126060|E1|Reported Event|Fibrin Sealant|drug used : fibrin sealant dosage : 1 vial method : spraying over surgical bed frequency : 1 vial at a time (no multiple usage)
887284|NCT01125930|B3|Baseline|Total|Total of all reporting groups
887285|NCT01125930|B2|Baseline|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887286|NCT01125930|B1|Baseline|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887287|NCT01125930|P2|Participant Flow|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887288|NCT01125930|P1|Participant Flow|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887289|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887290|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887291|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887292|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887293|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887294|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887295|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887296|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887297|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887298|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887469|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
887299|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887300|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887301|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887302|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887303|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887304|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887305|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887306|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887307|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887308|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887309|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887310|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887311|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887312|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887313|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887314|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887315|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887861|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
887316|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887317|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887318|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887319|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887320|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887321|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887322|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887323|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887324|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887325|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887326|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887327|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887328|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887329|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887330|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887331|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887332|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887862|NCT01124643|O1|Outcome|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
887333|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887334|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887335|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887336|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887337|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887338|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887339|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887340|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887341|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887342|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887343|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887344|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887345|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887346|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887347|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887348|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887349|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887863|NCT01124643|E1|Reported Event|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
887350|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887351|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887352|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887353|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887354|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887355|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887356|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887357|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887358|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887359|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887360|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887361|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887362|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887363|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887364|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887365|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887366|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887864|NCT01124617|B3|Baseline|Total|Total of all reporting groups
887367|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887368|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887369|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887370|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887371|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887372|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887373|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887374|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887375|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887376|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887377|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887378|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887379|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887380|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887381|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887382|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887383|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887470|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887384|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887385|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887386|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887387|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887388|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887389|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887390|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887391|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887392|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887393|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887394|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887395|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887396|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887397|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887398|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887399|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887400|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887471|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887401|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887402|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887403|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887404|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887405|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887406|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887407|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887408|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887409|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887410|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887411|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887412|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887413|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887414|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887415|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887416|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887417|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
888117|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
887418|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887419|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887420|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887421|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887422|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887423|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887424|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle Gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887425|NCT01125930|O10|Outcome|Atralin Gel at Week 24|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887426|NCT01125930|O9|Outcome|Vehicle Gel at Week 24|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887427|NCT01125930|O8|Outcome|Atralin Gel at Week 18|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887428|NCT01125930|O7|Outcome|Vehicle Gel at Week 18|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887429|NCT01125930|O6|Outcome|Atralin Gel at Week 12|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887430|NCT01125930|O5|Outcome|Vehicle Gel at Week 12|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887431|NCT01125930|O4|Outcome|Atralin Gel at Week 6|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887432|NCT01125930|O3|Outcome|Vehicle Gel at Week 6|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887433|NCT01125930|O2|Outcome|Atralin Gel at Week 2|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887434|NCT01125930|O1|Outcome|Vehicle Gel at Week 2|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
888118|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
887435|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887436|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887437|NCT01125930|O2|Outcome|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887438|NCT01125930|O1|Outcome|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887439|NCT01125930|E2|Reported Event|Atralin Gel|Atralin gel: Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
887440|NCT01125930|E1|Reported Event|Vehicle Gel|Vehicle gel: Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
887441|NCT01125917|B1|Baseline|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
887442|NCT01125917|P1|Participant Flow|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
887443|NCT01125917|O1|Outcome|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
887444|NCT01125917|E1|Reported Event|Total BTDS 5, 10, 20|Test treatment: Open-label buprenorphine transdermal patch 5, 10, or 20 mcg/h applied for 7-day wear
887445|NCT01125813|B1|Baseline|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
887446|NCT01125813|P1|Participant Flow|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
887447|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
887448|NCT01125813|O1|Outcome|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
887449|NCT01125813|E1|Reported Event|Human Cl-rhFVIII|recombinant Factor VIII : intravenous infusion of factor FVIII every other day.
887450|NCT01125800|B6|Baseline|Total|Total of all reporting groups
887451|NCT01125800|B5|Baseline|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
887452|NCT01125800|B4|Baseline|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
887453|NCT01125800|B3|Baseline|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887454|NCT01125800|B2|Baseline|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887455|NCT01125800|B1|Baseline|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887456|NCT01125800|P5|Participant Flow|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
887457|NCT01125800|P4|Participant Flow|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route. The Phase I , Phase II patients are pooled and summarized by dose levels. One pediatric patient enrolled in the Phase II portion at the 680 mg/m2 dose was pooled with 21 pediatric patients enrolled in Phase I at the same dose
887458|NCT01125800|P3|Participant Flow|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887459|NCT01125800|P2|Participant Flow|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887460|NCT01125800|P1|Participant Flow|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887461|NCT01125800|O2|Outcome|Adult Participants|All adult Participants were treated with sonidegib 800 mg once daily in phase II portion of the study. Pediatric patients were also enrolled in phase II portion of the study at the recommended phase II pediatric dose - 680 mg/m^2
887462|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
887463|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
887464|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
887465|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887466|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887467|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887468|NCT01125800|O1|Outcome|Pediatric Participants|All the pediatric Participants were treated with LDE225 dose determined in the Phase I (233, 372, 425 and 680 mg/m^2).
892191|NCT01115660|B3|Baseline|Total|Total of all reporting groups
887472|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887473|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
887474|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887475|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887476|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887477|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
887478|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887479|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887480|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887481|NCT01125800|O5|Outcome|Adult Participants, LDE225 800 mg|Adult Participants were treated with LDE225 800 mg capsule once daily.
887482|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
887483|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887484|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887485|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887486|NCT01125800|O1|Outcome|All Participants|All participants received LDE225 233, 372, 425, 680, 800 mg/m^2 once daily through oral route until disease progression, unacceptable toxicity, or consent withdrawal.
887487|NCT01125800|O4|Outcome|Pediatric Participants, LDE225 680 mg/m^2|Pediatric Participants received LDE225 680 mg/m^2 once daily through oral route.
887488|NCT01125800|O3|Outcome|Pediatric Participants, LDE225 425 mg/m^2|Pediatric Participants received LDE225 425 mg/m^2 once daily through oral route.
887489|NCT01125800|O2|Outcome|Pediatric Participants, LDE225 372 mg/m^2|Pediatric Participants received LDE225 372 mg/m^2 once daily through oral route.
887490|NCT01125800|O1|Outcome|Pediatric Participants, LDE225 233 mg/m^2|Pediatric Participants received LDE225 233 mg/m^2 once daily through oral route.
887491|NCT01125800|E5|Reported Event|Adult Participants, LDE225 800 mg|Adult participants were treated with LDE225 800 mg capsule once daily.
887492|NCT01125800|E4|Reported Event|Pediatric Participants, LDE225 680 mg/m^2|Pediatric participants received LDE225 680 mg/m^2 once daily through oral route.
887493|NCT01125800|E3|Reported Event|Pediatric Participants, LDE225 425 mg/m^2|Pediatric participants received LDE225 425 mg/m^2 once daily through oral route.
887494|NCT01125800|E2|Reported Event|Pediatric Participants, LDE225 372 mg/m^2|Pediatric participants received LDE225 372 mg/m^2 once daily through oral route.
887495|NCT01125800|E1|Reported Event|Pediatric Participants, LDE225 233 mg/m^2|Pediatric participants received LDE225 233 mg/m^2 once daily through oral route.
887496|NCT01125774|B3|Baseline|Total|Total of all reporting groups
887497|NCT01125774|B2|Baseline|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887498|NCT01125774|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887499|NCT01125774|P4|Participant Flow|Placebo - Duplicate Participants|Participants who were randomized at more than 1 study site and each time were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887500|NCT01125774|P3|Participant Flow|Telcagepant 140 mg - Duplicate Participants|Participants who were randomized at more than 1 study site and were randomized at least once to telcagepant and may also have been randomized to placebo. Study drug was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887501|NCT01125774|P2|Participant Flow|Placebo - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to placebo. Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887502|NCT01125774|P1|Participant Flow|Telcagepant 140 mg - Excluding Duplicate Participants|Participants who were randomized at only 1 study site and were randomized to telcagepant. Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887503|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887504|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887505|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
888119|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
887506|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887507|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887508|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887509|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887510|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887511|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887512|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887513|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887514|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887515|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887516|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887517|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887518|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887519|NCT01125774|O2|Outcome|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887520|NCT01125774|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887521|NCT01125774|E2|Reported Event|Placebo|Placebo was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887522|NCT01125774|E1|Reported Event|Telcagepant 140 mg|Telcagepant 140 mg was administered once daily at bedtime for 7 consecutive days each month, beginning at the onset of menses, for up to 6 months. Dosing could begin up to 3 days prior to menses onset if prodromal symptoms reliably predicted onset of menses.
887523|NCT01125748|B3|Baseline|Total|Total of all reporting groups
887524|NCT01125748|B2|Baseline|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
887525|NCT01125748|B1|Baseline|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
887526|NCT01125748|P2|Participant Flow|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
887527|NCT01125748|P1|Participant Flow|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
887528|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
887529|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
887530|NCT01125748|O2|Outcome|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
887531|NCT01125748|O1|Outcome|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
888120|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
887532|NCT01125748|E2|Reported Event|Placebo|Participants received placebo subcutaneously at the same dosing interval as omalizumab was administered prior to enrollment in this study.
887533|NCT01125748|E1|Reported Event|Omalizumab|Participants received omalizumab subcutaneously at the same dose and dosing interval as administered prior to enrollment in this study. The dose of omalizumab was either a minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.
887534|NCT01125722|B3|Baseline|Total|Total of all reporting groups
887535|NCT01125722|B2|Baseline|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887536|NCT01125722|B1|Baseline|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887537|NCT01125722|P2|Participant Flow|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887538|NCT01125722|P1|Participant Flow|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887539|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887540|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887541|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887542|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887543|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887544|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887545|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887546|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887547|NCT01125722|O2|Outcome|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887548|NCT01125722|O1|Outcome|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887549|NCT01125722|E2|Reported Event|Subject Placement Group|Nerve stimulation patch is placed by the investigator at Week 1 and then by the subjects at Weeks 2 through 4.
887550|NCT01125722|E1|Reported Event|Investigator Placement Group|Nerve stimulation patch is placed by the investigator at Weeks 1 through 4.
887551|NCT01125605|B1|Baseline|Observational Group|Pasconal Nerventropfen
887552|NCT01125605|P1|Participant Flow|Observational Group|Pasconal Nerventropfen PASCONAL® NERVENTROPFEN is a homoeopathic combination product (oral drops) consisting out of 4 ingredients: Avena sativa, Valeriana, Ignatia and Tarantula.
887553|NCT01125605|O2|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
887554|NCT01125605|O1|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
887555|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
887556|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
887557|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
887558|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
887559|NCT01125605|O2|Outcome|>= 4 Weeks|Observational group (Pasconal Nerventropfen) without concomitant medication
887560|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with concomitant medication
887561|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
887562|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 1
887563|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
887564|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
887565|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
887566|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
887567|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
887568|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
887569|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
887570|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
887571|NCT01125605|O2|Outcome|> = 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration >= 4 weeks
887572|NCT01125605|O1|Outcome|< 4 Weeks|Observational group (Pasconal Nerventropfen) with a treatment duration < 4 weeks
887573|NCT01125605|O2|Outcome|Without Concomitant Medication|Observational group (Pasconal Nerventropfen) without concomitant medication
887574|NCT01125605|O1|Outcome|With Concomitant Medication|Observational group (Pasconal Nerventropfen) with concomitant medication
887575|NCT01125605|O2|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
887576|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
887577|NCT01125605|O4|Outcome|Last Observation|Observational group (Pasconal Nerventropfen) at last observation
887578|NCT01125605|O3|Outcome|Visit 3|Observational group (Pasconal Nerventropfen) at visit 3
887579|NCT01125605|O2|Outcome|Visit 2|Observational group (Pasconal Nerventropfen) at visit 2
887580|NCT01125605|O1|Outcome|Visit 1|Observational group (Pasconal Nerventropfen) at visit 1
887581|NCT01125605|E1|Reported Event|Observational Group|Pasconal Nerventropfen
887582|NCT01125566|B3|Baseline|Total|Total of all reporting groups
893483|NCT01110239|O3|Outcome|7.5 Min Ischemia|
887583|NCT01125566|B2|Baseline|Trastuzumab + Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
887584|NCT01125566|B1|Baseline|Afatinib + Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
887585|NCT01125566|P3|Participant Flow|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
887586|NCT01125566|P2|Participant Flow|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
887587|NCT01125566|P1|Participant Flow|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
887588|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
887589|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
887590|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
887591|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
887592|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
887593|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
887594|NCT01125566|O2|Outcome|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
887595|NCT01125566|O1|Outcome|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
887596|NCT01125566|E3|Reported Event|AV Switched to TV|This group describes patients who crossed over from AV to TV following DMC recommendation to terminate recruitment on 26Apr2013. Patients discontinued AV and switched to TV if they were without disease progression on Afatinib+ Vinorelbine treatment on 26Apr2013.
887597|NCT01125566|E2|Reported Event|Trastuzumab+ Vinorelbine (TV)|Patients received weekly infusion of Trastuzumab (2 mg/ kg, following an initial loading dose of 4 mg/ kg) and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days.
887598|NCT01125566|E1|Reported Event|Afatinib+ Vinorelbine (AV)|Patients received continuous daily treatment with afatinib at a starting dose of 40 mg once daily and weekly infusions of vinorelbine (25mg/m^2). The treatment was administered in treatment courses of 28 days. For afatinib, a protocol- defined dose-reduction scheme was to be followed if a patient experienced certain pre-specified adverse events. All patients without disease progression who were on treatment on 26Apr2013 had to immediately discontinue Afatinib+ Vinorelbine combination treatment. Patients in this group could continue with either vinorelbine or afatinib monotherapy if they experienced clinical benefit.
887865|NCT01124617|B2|Baseline|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887599|NCT01125514|B1|Baseline|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
887600|NCT01125514|P1|Participant Flow|Furosemide (Fu) /Fu+Aliskiren(Alis)150mg/fu+Alis 300mg|"Treatment period 1 (Day 1 to Day 7): All eligible patients received 60 mg furosemide, 150 mg placebo of aliskiren, and 300 mg placebo aliskiren once daily.~Treatment Period 2 (Day 8 to day 17): Patients received 60 mg furosemide, 150 mg aliskiren and 300 mg placebo once daily.~Treatment Period 3 (Day 18 to day 27): Patients received 60 mg furosemide, 300 mg aliskiren and 150 mg placebo of aliskiren once daily.~Day 28, no study treatment."
887601|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887602|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887603|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887604|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887605|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887606|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887607|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887608|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887609|NCT01125514|O3|Outcome|Furosemide go mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887610|NCT01125514|O2|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887611|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887612|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887613|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887614|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887615|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887616|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887617|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887618|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887619|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887620|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887621|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887622|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887623|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887624|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887625|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887626|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887627|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887628|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887629|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887630|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887631|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887632|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887633|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887634|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887635|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
893484|NCT01110239|O2|Outcome|5 Min Ischemia|
887636|NCT01125514|O4|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887637|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887638|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887639|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887640|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887641|NCT01125514|O3|Outcome|Furosemide 60 mg+ Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887642|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887643|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887644|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887645|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887646|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887647|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887648|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887649|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887650|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887651|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887652|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887653|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887654|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887655|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887656|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887657|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887658|NCT01125514|O2|Outcome|Furosemide 60 mg + Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887659|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887660|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887661|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887662|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887663|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887664|NCT01125514|O4|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 300mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 300mg ( day 18 - day 27).
887665|NCT01125514|O3|Outcome|Furosemide 60 mg + Multiple Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg ( day 9 - day 17).
887666|NCT01125514|O2|Outcome|Furosemide 60 mg+ Single Dose Aliskiren 150mg|Patient received 60 mg furosemide at steady state + single dose aliskiren 150mg on day 8.
887667|NCT01125514|O1|Outcome|Furosemide 60 mg + Aliskiren Placebo|Patient received 60 mg furosemide at steady state + placebo to aliskiren from day 1 to day 7.
887668|NCT01125514|E3|Reported Event|60 mg Furosemide + 300 mg Aliskiren + 150 mg Placebo|60 mg furosemide + 300 mg aliskiren + 150 mg placebo
887669|NCT01125514|E2|Reported Event|60 mg Furosemide + 150 mg Aliskiren + 300 mg Placebo|60 mg furosemide + 150 mg aliskiren + 300 mg placebo
887670|NCT01125514|E1|Reported Event|60 mg Furosemide + 150 mg Placebo + 300 mg Placebo|60 mg furosemide + 150 mg placebo + 300 mg placebo
887671|NCT01125189|B4|Baseline|Total|Total of all reporting groups
887672|NCT01125189|B3|Baseline|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887673|NCT01125189|B2|Baseline|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
888121|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
887674|NCT01125189|B1|Baseline|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887675|NCT01125189|P3|Participant Flow|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887676|NCT01125189|P2|Participant Flow|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887677|NCT01125189|P1|Participant Flow|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887678|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887679|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887680|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887681|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887682|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887683|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887684|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylate-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887685|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887686|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887687|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887703|NCT01125098|B2|Baseline|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
895409|NCT01104701|B5|Baseline|Total|Total of all reporting groups
887688|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887689|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887690|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887691|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887692|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887693|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887694|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887695|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887696|NCT01125189|O3|Outcome|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887697|NCT01125189|O2|Outcome|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887698|NCT01125189|O1|Outcome|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the participant achieved an on-treatment response as defined in protocol.
887699|NCT01125189|E3|Reported Event|Placebo + Peg-interferon Alfa-2a + Ribavirin|Participants received placebo matched with daclatasvir tablets orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily, for a total duration of 24 weeks and pegylated-interferon alfa-2a and ribavirin, for a total duration of 48 weeks.
887700|NCT01125189|E2|Reported Event|Daclatasvir (60 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 60 mg orally, once daily with pegylated-interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
887701|NCT01125189|E1|Reported Event|Daclatasvir (20 mg) + Peg-interferon Alfa-2a + Ribavirin|Participants received daclatasvir tablets 20 mg orally, once daily with pegylated-­interferon alfa-2a solution for injection 180 µg per 0.5 mL subcutaneously, once weekly, and ribavirin tablets 1000-1200 mg orally, twice daily for a total duration of 12 weeks. After Week 12, additional treatment was provided with interferon and ribavirin for a total of 24 or 48 weeks of therapy depending on whether or not the patient achieved an on-treatment response as defined in protocol.
887702|NCT01125098|B3|Baseline|Total|Total of all reporting groups
888122|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
887704|NCT01125098|B1|Baseline|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
887705|NCT01125098|P2|Participant Flow|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
887706|NCT01125098|P1|Participant Flow|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
887707|NCT01125098|O2|Outcome|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
887708|NCT01125098|O1|Outcome|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
887709|NCT01125098|E2|Reported Event|Standard Group: No Intervention|COPD patients in the Standard group will continue antibiotic therapy for 10 days according to guidelines recommended treatment plan in case of COPD exacerbations.
887710|NCT01125098|E1|Reported Event|PRO-CT Group: Experimental|"COPD patients in the PRO-CT group will continue or discontinue antibiotic therapy depending on PRO-CT values.~PRO-CT values: - continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
887711|NCT01124955|B3|Baseline|Total|Total of all reporting groups
887712|NCT01124955|B2|Baseline|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887713|NCT01124955|B1|Baseline|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887714|NCT01124955|P2|Participant Flow|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887715|NCT01124955|P1|Participant Flow|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887716|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887717|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887718|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887719|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887720|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887721|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887722|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887723|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887724|NCT01124955|O2|Outcome|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887725|NCT01124955|O1|Outcome|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887726|NCT01124955|E2|Reported Event|Placebo Group|Patients were submitted to five non-penetrating acupuncture sessions in the placebo group (PG).
887727|NCT01124955|E1|Reported Event|Acupuncture|The technique of acupuncture used in this study is Yamamoto New Scalp Acupuncture called YNSA.
887728|NCT01124916|B3|Baseline|Total|Total of all reporting groups
887729|NCT01124916|B2|Baseline|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
887730|NCT01124916|B1|Baseline|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
888123|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
887731|NCT01124916|P2|Participant Flow|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
887732|NCT01124916|P1|Participant Flow|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
887733|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
887734|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
887735|NCT01124916|O2|Outcome|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
887736|NCT01124916|O1|Outcome|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
887737|NCT01124916|E2|Reported Event|Robotic Assisted Laparoscopic (RASC)|Women assigned to this cohort will receive robotic assisted laparoscopic abdominal sacrocolpopexy (RASC)
887738|NCT01124916|E1|Reported Event|Laparoscopic Abdominal Sacrocolpopexy (LASC)|Women assigned to this cohort will receive standard laparoscopic abdominal sacrocolpopexy (LASC)
887739|NCT01124864|B7|Baseline|Total|Total of all reporting groups
887740|NCT01124864|B6|Baseline|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887741|NCT01124864|B5|Baseline|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887742|NCT01124864|B4|Baseline|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887743|NCT01124864|B3|Baseline|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887744|NCT01124864|B2|Baseline|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
887745|NCT01124864|B1|Baseline|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887746|NCT01124864|P6|Participant Flow||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887747|NCT01124864|P5|Participant Flow|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887748|NCT01124864|P4|Participant Flow|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887749|NCT01124864|P3|Participant Flow|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887750|NCT01124864|P2|Participant Flow|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
887751|NCT01124864|P1|Participant Flow|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887752|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
887753|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
887754|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
887755|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
887756|NCT01124864|O2|Outcome|BJP762|AUY Metabolite
887757|NCT01124864|O1|Outcome|AUY922|AUY922 Plasma Concentration
887758|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887759|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887760|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
888124|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
887761|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887762|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
887763|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887764|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887765|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887766|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887767|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887768|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
887769|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887770|NCT01124864|O6|Outcome|Unknown|For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887771|NCT01124864|O5|Outcome|Modified EGFR Mutant Patients|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887772|NCT01124864|O4|Outcome|Patients With EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887773|NCT01124864|O3|Outcome|EGFR and Kras Wild Type Patients|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887774|NCT01124864|O2|Outcome|EGFR Mutant Patients|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
887775|NCT01124864|O1|Outcome|Kras Mutant Patients|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887776|NCT01124864|E6|Reported Event||For some patients, it was not possible to determine their genotype, and hence their stratum membership could not be determined. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887777|NCT01124864|E5|Reported Event|Modified EGFR Mutant|The modified EGFR stratum was defined as patients less heavily pretreated who had received one or two lines of prior therapy, with a documented response to a EGFR tyrosine kinase inhibitor (TKI) (complete response (CR), partial response (PR) or stable disease (SD) for ≥ 6 months), unless the patient had de novo resistance to EGFR TKI.Patients received AUY922 at 70 mg/m^2 weekly infusions.
887778|NCT01124864|E4|Reported Event|EML4-ALK Translocation|Patients with NSCLC who have tumors with an inversion in the short arm of chromosome 2 that results in the fusion of the echinoderm microtubule-associated protein-like 4 (EML4) gene with the ALK gene leading to the production of an EML4-ALK fusion tyrosine kinase. ALK is a transmembrane protein, which has a kinase domain and is not usually expressed in the lung. EML4 mediate ligand-independent dimerization, and therefore constitutive activity of the ALK tyrosine kinase domain. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887779|NCT01124864|E3|Reported Event|KRAS and EGFR Wild Type|Patients exhibiting both mutations were stratified to the KRAS mutation stratum. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887780|NCT01124864|E2|Reported Event|EGFR Mutant|Patients with EGFR activating mutation tumors (Note: These patients must have progressed on one prior EGFR TKI containing regimen unless they have documented T790M activating mutation). Patients received AUY922 at 70 mg/m^2 weekly infusions.
887781|NCT01124864|E1|Reported Event|KRAS Mutant|Patients with KRAS mutant tumors. Patients received AUY922 at 70 mg/m^2 weekly infusions.
887782|NCT01124838|B3|Baseline|Total|Total of all reporting groups
887783|NCT01124838|B2|Baseline|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887784|NCT01124838|B1|Baseline|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887850|NCT01124786|E2|Reported Event|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887785|NCT01124838|P2|Participant Flow|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887786|NCT01124838|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887787|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887788|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887789|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887790|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887791|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887792|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887793|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887794|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887795|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887796|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887797|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887798|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887799|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887800|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887801|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887851|NCT01124786|E1|Reported Event|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887852|NCT01124643|B1|Baseline|Replagal® (0.2 mg/kg)|Replagal 0.2 mg/kg IV, EOW
887802|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887803|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887804|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887805|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887806|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887807|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887808|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887809|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887810|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887811|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887812|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887813|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887814|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887815|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887816|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887817|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887818|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887853|NCT01124643|P1|Participant Flow|Replagal® (0.2 mg/kg)|Replagal 0.2 milligram per kilogram (mg/kg) intravenously (IV), every other week (EOW).
887819|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887820|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887821|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887822|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887823|NCT01124838|O4|Outcome|Integrated Study (Main + Japan Sub-study): Adalimumab|Participants, including those enrolled in the Main Study and the Japan Sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887824|NCT01124838|O3|Outcome|Integrated Study (Main + Japan Sub-study): Placebo|Participants, including those enrolled in the Main Study and the Japan Sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887825|NCT01124838|O2|Outcome|Main Study: Adalimumab|Participants, excluding those enrolled in the Japan sub-study, received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887826|NCT01124838|O1|Outcome|Main Study: Placebo|Participants, excluding those enrolled in the Japan sub-study, received placebo subcutaneous injection at Baseline followed by eow dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887827|NCT01124838|E2|Reported Event|Adalimumab|Participants received adalimumab 80 mg subcutaneous loading dose at Baseline followed by 40 mg doses eow starting at Week 1 for a maximum of 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887828|NCT01124838|E1|Reported Event|Placebo|Participants received placebo subcutaneous injection at Baseline followed by every other week (eow) dosing starting at Week 1 for up to 80 weeks or until treatment failure. Participants continued to receive prednisone orally, 10 to 35 mg/day at study entry followed by a protocol-defined mandatory taper until Week 19.
887829|NCT01124786|B3|Baseline|Total|Total of all reporting groups
887830|NCT01124786|B2|Baseline|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887831|NCT01124786|B1|Baseline|Gemcitabine Elaidate|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887832|NCT01124786|P2|Participant Flow|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887833|NCT01124786|P1|Participant Flow|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887834|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887835|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887836|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887837|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887838|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887839|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887840|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887841|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887842|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887843|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887844|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887845|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887846|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887847|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887848|NCT01124786|O2|Outcome|Gemcitabine|Gemcitabine : 1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
887849|NCT01124786|O1|Outcome|CO-1.01|CO-1.01 : 1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
887866|NCT01124617|B1|Baseline|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887867|NCT01124617|P2|Participant Flow|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887868|NCT01124617|P1|Participant Flow|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887869|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887870|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887871|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887872|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887873|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887874|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887875|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887876|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887877|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887878|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887879|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887880|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887881|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887882|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887883|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887884|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887885|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887886|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887887|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887888|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887889|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887890|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887891|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887892|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887893|NCT01124617|O2|Outcome|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887894|NCT01124617|O1|Outcome|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887895|NCT01124617|E2|Reported Event|Placebo|Matching Placebo was administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
887896|NCT01124617|E1|Reported Event|Tapentadol|Tapentadol hydrochloride extended-release(ER) was administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
887897|NCT01124604|B3|Baseline|Total|Total of all reporting groups
887898|NCT01124604|B2|Baseline|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887899|NCT01124604|B1|Baseline|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887900|NCT01124604|P2|Participant Flow|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887901|NCT01124604|P1|Participant Flow|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887902|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887903|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
895524|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
887904|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887905|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887906|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887907|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887908|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887909|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887910|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887911|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887912|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887913|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887914|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887915|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887916|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887917|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887918|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887919|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887920|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887921|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887922|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887923|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887924|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887925|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887926|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887927|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887928|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887929|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887930|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887931|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887932|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887933|NCT01124604|O2|Outcome|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887934|NCT01124604|O1|Outcome|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
888125|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
887935|NCT01124604|E2|Reported Event|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887936|NCT01124604|E1|Reported Event|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) were administered orally twice daily for 12 weeks. Dose was adjusted as per Investigator's discretion.
887937|NCT01124448|B3|Baseline|Total|Total of all reporting groups
887938|NCT01124448|B2|Baseline|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
887939|NCT01124448|B1|Baseline|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
887940|NCT01124448|P2|Participant Flow|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
887941|NCT01124448|P1|Participant Flow|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
887942|NCT01124448|O2|Outcome|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
887943|NCT01124448|O1|Outcome|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
887944|NCT01124448|E2|Reported Event|Lactobacillus Salivarius PS2B|"Lactating women without mastitis (n=15)~Lactobacillus salivarius PS2: 9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days"
887945|NCT01124448|E1|Reported Event|Lactobacillus Salivarius PS2|"Women with mastitis (n=25) receiving Lactobacillus salivarius PS2 (9.5 log per day, 21 days)~Lactobacillus salivarius PS2: 9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days"
887946|NCT01124422|B3|Baseline|Total|Total of all reporting groups
887947|NCT01124422|B2|Baseline|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887948|NCT01124422|B1|Baseline|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
887949|NCT01124422|P3|Participant Flow|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887950|NCT01124422|P2|Participant Flow|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
887951|NCT01124422|P1|Participant Flow|Tiotropium (TIO)|Tiotropium (TIO) was administered in the dose of 18 micrograms (mcg) once daily for a duration of 4 weeks
887952|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887953|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887954|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887955|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887956|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887957|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887958|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887959|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887960|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887961|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887962|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887963|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887964|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887965|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887966|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887967|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887968|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887969|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887970|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887971|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
888126|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
887972|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887973|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887974|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887975|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887976|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887977|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887978|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887979|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887980|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887981|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887982|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887983|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887984|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887985|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
887986|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887987|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
887988|NCT01124422|O2|Outcome|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887989|NCT01124422|O1|Outcome|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
887990|NCT01124422|E2|Reported Event|TIO+FSC|Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
887991|NCT01124422|E1|Reported Event|TIO+Placebo|Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
887992|NCT01124370|B1|Baseline|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
887993|NCT01124370|P1|Participant Flow|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
887994|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
887995|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
887996|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
887997|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
887998|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
887999|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
888000|NCT01124370|O1|Outcome|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
888001|NCT01124370|E1|Reported Event|Treatment|Implantation of the remedē system which provides unilateral transvenous phrenic nerve stimulation therapy during sleep.
888002|NCT01124305|B3|Baseline|Total|Total of all reporting groups
888003|NCT01124305|B2|Baseline|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
888004|NCT01124305|B1|Baseline|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
888005|NCT01124305|P2|Participant Flow|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
888006|NCT01124305|P1|Participant Flow|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
888007|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
888008|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
888009|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
888010|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
888011|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
888012|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
888127|NCT01124162|E2|Reported Event|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
888013|NCT01124305|O2|Outcome|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
888014|NCT01124305|O1|Outcome|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
888015|NCT01124305|E2|Reported Event|Customized Patient Instrumentation|Experimental group: Cases performed with custom instruments specifically made for each patient using pre-op CT scans.
888016|NCT01124305|E1|Reported Event|Traditional Instrumentation|Control group: Cases performed with traditional surgical instruments
888017|NCT01124292|B4|Baseline|Total|Total of all reporting groups
888018|NCT01124292|B3|Baseline|Subjects With Spinal Cord Injury|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888019|NCT01124292|B2|Baseline|Able-bodied Subject Without Tongue Piercing:|Able-bodied subjects who willing to receive a tongue piercing for this study.
888020|NCT01124292|B1|Baseline|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
888021|NCT01124292|P3|Participant Flow|Subjects With Spinal Cord Injury|persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888022|NCT01124292|P2|Participant Flow|Able-bodied Subject Without Tongue Piercing|Able-bodied subjects who willing to receive a tongue piercing for this study.
888023|NCT01124292|P1|Participant Flow|Able-bodied Subject With Tongue Piercing|Able-bodied subjects who already have tongue piercing.
888024|NCT01124292|O4|Outcome|Subjects With Spinal Cord Injury (Group-C): Wheelchair Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888025|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C): Computer Session|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888026|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888027|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888028|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888029|NCT01124292|O1|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888030|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888031|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888032|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888033|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888034|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888035|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888036|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888037|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888038|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888039|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888040|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888041|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888042|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888043|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888044|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888045|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888046|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888047|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888128|NCT01124162|E1|Reported Event|Losartan|100 mg Losartan Tablets test product dosed in either period.
895525|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
888048|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888049|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888050|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888051|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888052|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888053|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888054|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888055|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888056|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888057|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888058|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888059|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888060|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888061|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888062|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888063|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888064|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888065|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888066|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888067|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888068|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888069|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888070|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888071|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888072|NCT01124292|O3|Outcome|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888073|NCT01124292|O2|Outcome|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888074|NCT01124292|O1|Outcome|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888075|NCT01124292|E3|Reported Event|Subjects With Spinal Cord Injury (Group-C)|Persons with mobility limitations requiring power wheel chair, able to move tongue, able to follow simple commands, and have some experience with computers. All participants willingly received a mid-line tongue piercing.
888076|NCT01124292|E2|Reported Event|Able-bodied Subject Without Tongue Piercing (Group-B)|Able-bodied subjects who willing to receive a tongue piercing for this study.
888077|NCT01124292|E1|Reported Event|Able-bodied Subject With Tongue Piercing (Group-A)|Able-bodied subjects who already have tongue piercing.
888078|NCT01124188|B3|Baseline|Total|Total of all reporting groups
888079|NCT01124188|B2|Baseline|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
888080|NCT01124188|B1|Baseline|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
888114|NCT01124162|P1|Participant Flow|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
888115|NCT01124162|O2|Outcome|Cozaar®|100 mg Cozaar® Tablets reference product dosed in either period.
888081|NCT01124188|P2|Participant Flow|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
888082|NCT01124188|P1|Participant Flow|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
888083|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
888084|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
888085|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
888086|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
888087|NCT01124188|O2|Outcome|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
888088|NCT01124188|O1|Outcome|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
888089|NCT01124188|E2|Reported Event|Active Control|"Higher-dose venlafaxine and supportive management (SM)~Higher-dose venlafaxine and supportive management: The dose of venlafaxine will be between 187.5-300 mg/day. It will be offered with supportive management which encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks."
888090|NCT01124188|E1|Reported Event|Study Intervention Arm|"Higher-dose venlafaxine and Problem Solving Therapy for Depression and Pain (PST-DP)~Combination Treatment with Higher-dose venlafaxine + PST-DP: Dosing of venlafaxine will range from 187.5-300 mg/day. Medication management and PST-DP will be delivered over the course of 10 sessions over 14 weeks."
888091|NCT01124175|B3|Baseline|Total|Total of all reporting groups
888092|NCT01124175|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
888093|NCT01124175|B1|Baseline|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
888094|NCT01124175|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
888095|NCT01124175|P1|Participant Flow|Losartan (Test) First|100 mg Losartan tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
888096|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
888097|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
888098|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
888099|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
888100|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
888101|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
888102|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
888103|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
888104|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
888105|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
888106|NCT01124175|O2|Outcome|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
888107|NCT01124175|O1|Outcome|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
888108|NCT01124175|E2|Reported Event|Cozaar® (Reference)|100 mg Cozaar® Tablets reference product dosed in either period.
888109|NCT01124175|E1|Reported Event|Losartan (Test)|100 mg Losartan tablets test product dosed in either period.
888110|NCT01124162|B3|Baseline|Total|Total of all reporting groups
888111|NCT01124162|B2|Baseline|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
888112|NCT01124162|B1|Baseline|Losartan (Test) First|100 mg Losartan Tablets test product dosed in first period followed by 100 mg Cozaar® Tablets reference product dosed in the second period.
888113|NCT01124162|P2|Participant Flow|Cozaar® (Reference) First|100 mg Cozaar® Tablets reference product dosed in first period followed by 100 mg Losartan Tablets test product dosed in the second period.
888116|NCT01124162|O1|Outcome|Losartan|100 mg Losartan Tablets test product dosed in either period.
888129|NCT01124149|B1|Baseline|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
888130|NCT01124149|P1|Participant Flow|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase
888131|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
888132|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
888133|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
888134|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine|4.8g/day given QD for 8 weeks in the Acute Phase
888135|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888136|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888137|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888138|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888139|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888140|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888141|NCT01124149|O2|Outcome|MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888142|NCT01124149|O1|Outcome|MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)|Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
888143|NCT01124149|E2|Reported Event|MMX Mesalamine/ Mesalazine (Maintenance Phase)|2.4 g/day given QD for 12 months in the Maintenance Phase
888144|NCT01124149|E1|Reported Event|MMX Mesalamine/ Mesalazine (Acute Phase)|4.8g/day given QD for 8 weeks in the Acute Phase
888145|NCT01124097|B5|Baseline|Total|Total of all reporting groups
888146|NCT01124097|B4|Baseline|Placebo|Placebo: Tablets will be used.
888147|NCT01124097|B3|Baseline|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888148|NCT01124097|B2|Baseline|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888149|NCT01124097|B1|Baseline|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888150|NCT01124097|P4|Participant Flow|Placebo|Placebo: Tablets will be used.
888151|NCT01124097|P3|Participant Flow|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888152|NCT01124097|P2|Participant Flow|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888153|NCT01124097|P1|Participant Flow|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888154|NCT01124097|O4|Outcome|Placebo|Placebo: Tablets will be used.
888155|NCT01124097|O3|Outcome|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888156|NCT01124097|O2|Outcome|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888157|NCT01124097|O1|Outcome|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888158|NCT01124097|E4|Reported Event|Placebo|Placebo: Tablets will be used.
888159|NCT01124097|E3|Reported Event|Esl 800 mg Once Daily (QD)|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888160|NCT01124097|E2|Reported Event|Esl 1200 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888161|NCT01124097|E1|Reported Event|Esl 1600 mg QD|Eslicarbazepine acetate (Esl) (BIA 2-093): Tablets will be used.
888162|NCT01124045|B3|Baseline|Total|Total of all reporting groups
888269|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888163|NCT01124045|B2|Baseline|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888164|NCT01124045|B1|Baseline|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888165|NCT01124045|P2|Participant Flow|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888166|NCT01124045|P1|Participant Flow|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888167|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888168|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888169|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888170|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888171|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888172|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888173|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888174|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888175|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888176|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888177|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888178|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888179|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888180|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888181|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888182|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888183|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888231|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888184|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888185|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888186|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888187|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888188|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888189|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888190|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888191|NCT01124045|O2|Outcome|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888192|NCT01124045|O1|Outcome|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888193|NCT01124045|E2|Reported Event|PRED FORTE|Prednisolone acetate ophthalmic suspension, 1.0%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888194|NCT01124045|E1|Reported Event|DUREZOL|Difluprednate ophthalmic emulsion, 0.05%, 1 drop in the study eye at the end of surgery (Day 0) and 4 times a day beginning on the day after surgery (Day 1) for 14 days, followed by a tapering period of 14 days, dependent upon the Investigator's determination of adequate response to treatment
888195|NCT01124006|B4|Baseline|Total|Total of all reporting groups
888196|NCT01124006|B3|Baseline|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888197|NCT01124006|B2|Baseline|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888198|NCT01124006|B1|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888199|NCT01124006|P3|Participant Flow|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888200|NCT01124006|P2|Participant Flow|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888201|NCT01124006|P1|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888202|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888203|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888204|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888205|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888206|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
889135|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
888207|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888208|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888209|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888210|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888211|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888212|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888213|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888214|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888215|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888216|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888217|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888218|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888219|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888220|NCT01124006|O3|Outcome|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888221|NCT01124006|O2|Outcome|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888222|NCT01124006|O1|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888223|NCT01124006|E3|Reported Event|Intradiscal rhGDF-5 (2.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888224|NCT01124006|E2|Reported Event|Placebo|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
888225|NCT01124006|E1|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
888226|NCT01123980|B3|Baseline|Total|Total of all reporting groups
888227|NCT01123980|B2|Baseline|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888228|NCT01123980|B1|Baseline|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888229|NCT01123980|P2|Participant Flow|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888230|NCT01123980|P1|Participant Flow|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888232|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888233|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888234|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888235|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888236|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888237|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888238|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888239|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888240|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888241|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888242|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888243|NCT01123980|O2|Outcome|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888244|NCT01123980|O1|Outcome|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888245|NCT01123980|E2|Reported Event|Insulin Glargine|0.1-0.2U/kg (starting dose) administered once daily (OD) at bedtime in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888246|NCT01123980|E1|Reported Event|BIAsp 30|0.1-0.2 U/kg (starting dose) administered once daily (OD) immediately before dinner in combination with at least 1500 mg (Chinese patients) or 500 mg (Japanese patients) total daily dose of metformin and at least 4 mg glimepiride
888247|NCT01123941|B3|Baseline|Total|Total of all reporting groups
888248|NCT01123941|B2|Baseline|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
888249|NCT01123941|B1|Baseline|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
888250|NCT01123941|P2|Participant Flow|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
888251|NCT01123941|P1|Participant Flow|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
888252|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
888253|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
888254|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
888255|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
888256|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
888257|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
888258|NCT01123941|O2|Outcome|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
888259|NCT01123941|O1|Outcome|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
888260|NCT01123941|E2|Reported Event|Typherix|1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
888261|NCT01123941|E1|Reported Event|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
888262|NCT01123928|B3|Baseline|Total|Total of all reporting groups
888263|NCT01123928|B2|Baseline|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888264|NCT01123928|B1|Baseline|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888265|NCT01123928|P2|Participant Flow|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888266|NCT01123928|P1|Participant Flow|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888267|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888268|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
889136|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
888270|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888271|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888272|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888273|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888274|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888275|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888276|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888277|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888278|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888279|NCT01123928|O2|Outcome|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888280|NCT01123928|O1|Outcome|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888281|NCT01123928|E2|Reported Event|Non-counseling|Subjects will be told that they had decreased vision due to cataract and that this could be treated, without being shown the video or given the counseling session by the nurse.
888282|NCT01123928|E1|Reported Event|Counseling|Subjects will be asked to watch a 5-10 min video and participate in a 10-15 min pre-operative counseling session with a trained nurse. Subjects will also participate in a 5 min post-operative counseling session.
888283|NCT01123889|B3|Baseline|Total|Total of all reporting groups
888284|NCT01123889|B2|Baseline|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
888285|NCT01123889|B1|Baseline|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
888286|NCT01123889|P2|Participant Flow|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
888287|NCT01123889|P1|Participant Flow|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
888288|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
888289|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
888290|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
890147|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
888291|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
888292|NCT01123889|O2|Outcome|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
888293|NCT01123889|O1|Outcome|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
888294|NCT01123889|E2|Reported Event|Experimental|"patients will receive an injection of platelet rich plasma into the subacromial space~platelet rich plasma injection : 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions."
888295|NCT01123889|E1|Reported Event|Control|"corticosteroid injection into subacromial space~corticosteroid injection : Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions."
888296|NCT01123850|B1|Baseline|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
888297|NCT01123850|P1|Participant Flow|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
888298|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
888299|NCT01123850|O1|Outcome|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
888300|NCT01123850|E1|Reported Event|Single ARM - Copios Bone Filler|"All subjects will undergo an instrumented, pedicle screw PLF procedure. Autograft or other interbody devices identified by the surgeon to be in the best interest of the patient may be used. Enrolled patients will receive CopiOs BVF sponge soaked with bone marrow aspirate on one side and autologous bone on the other side. All patients will receive both CopiOs BVF and autologous bone. Patients will serve as self-controls in this counter-balanced study.~Copios: Bone Void Filler"
888301|NCT01123642|B1|Baseline|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
888302|NCT01123642|P1|Participant Flow|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
888303|NCT01123642|O1|Outcome|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
888304|NCT01123642|E1|Reported Event|OEF/OIF/OND Veterans|Operations Enduring Freedom, Iraqi Freedom and New Dawn Veterans
888305|NCT01123512|B3|Baseline|Total|Total of all reporting groups
888306|NCT01123512|B2|Baseline|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
888307|NCT01123512|B1|Baseline|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
888308|NCT01123512|P2|Participant Flow|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
888309|NCT01123512|P1|Participant Flow|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
888701|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888310|NCT01123512|O2|Outcome|Balloon Kyphoplasty|The balloon kyphoplasty procedure involved placing an inflatable bone tamp into the vertebral body that was then inflated under fluoroscopic guidance to create a void. This void was then filled with PMMA.
888311|NCT01123512|O1|Outcome|Kiva VCF Treatment System|The Kiva® VCF Treatment System is a multi-component, single-use device designed for obtaining unilateral access to the vertebral body in order to deliver the Kiva Implant and bone cement to stabilize osteoporotic vertebral fractures. The Kiva procedure involved placement of the Kiva Implant into the vertebral body followed by injection of PMMA into the Kiva Implant.
888312|NCT01123512|E2|Reported Event|Balloon Kyphoplasty|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
888313|NCT01123512|E1|Reported Event|Kiva VCF Treatment System|Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures
888314|NCT01123395|B1|Baseline|Colcrys® Intact Tab and Colcrys® Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one tablet of intact Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
888315|NCT01123395|P2|Participant Flow|Colcrys® Dissolved in Apple Juice Then Colcrys® Intact Tab|On the morning of Day 1 subjects received one tablet of the test formulation, Colcrys® 0.6 mg, crushed and dissolved in 20 mL of apple juice after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received one dose of the reference formulation, one intact Colcrys® 0.6 mg tablet, after an overnight fast of at least 10 hours.
888316|NCT01123395|P1|Participant Flow|Colcrys® Intact Tab Then Colcrys® Dissolved in Apple Juice|On the morning of Day 1, subjects received the reference formulation, one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours. Following a 14 day washout period, on the morning of Day 15, subjects received the test formulation, one Colcrys® 0.6 mg tablet crushed and dissolved in 20 mL of apple juice, after an overnight fast of at least 10 hours
888317|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
888318|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
888319|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
888320|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
888321|NCT01123395|O2|Outcome|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|Each subject received one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice after an overnight fast of at least 10 hours
888322|NCT01123395|O1|Outcome|Colcrys® 0.6 mg Administered as an Intact Tablet|Each subject received one intact tablet of Colcrys® 0.6 mg after an overnight fast of at least 10 hours
888323|NCT01123395|E2|Reported Event|Colcrys® 0.6 mg Tablet Crushed and Dissolved in Apple Juice|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
888324|NCT01123395|E1|Reported Event|Colcrys® 0.6 mg Tablet Administered Intact|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 15, each subject received one intact tablet of Colcrys® 0.6 mg or one tablet of Colcrys® 0.6 mg crushed and dissolved in apple juice, following an overnight fast of at least 10 hours.
888325|NCT01123356|B1|Baseline|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
888326|NCT01123356|P1|Participant Flow|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
888327|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
888328|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
888329|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
888330|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles~Ofatumumab: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)~-Treatment to be administered for up to 6 cycles~Lenalidomide: -Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)"
888331|NCT01123356|O1|Outcome|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
888332|NCT01123356|E1|Reported Event|Oratumumab and Lenalidomide|"Single arm, non randomized study~Ofatumumab, Lenalidomide: -Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1.~Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28.~Treatment to be administered for up to 6 cycles"
888333|NCT01123200|B1|Baseline|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
888334|NCT01123200|P1|Participant Flow|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
888335|NCT01123200|O1|Outcome|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
888336|NCT01123200|O1|Outcome|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
888337|NCT01123200|E1|Reported Event|Brain Computer Interface In-Home Use|Brain Computer Interface for Wheelchair Tilt Control: Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
888338|NCT01123161|B3|Baseline|Total|Total of all reporting groups
888339|NCT01123161|B2|Baseline|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
888340|NCT01123161|B1|Baseline|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888341|NCT01123161|P2|Participant Flow|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
888342|NCT01123161|P1|Participant Flow|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888343|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
888344|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888345|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering treatment includes buspirone, meperidine, and surface warming."
888346|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888347|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming."
888348|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888349|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
888350|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888351|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
888352|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888353|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine, and surface warming"
888354|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888355|NCT01123161|O2|Outcome|Group 2 : IV t-PA and Hypothermia|"IV tpa and hypothermia~hypothermia: Hypothermia is induced using the Celsius Control™ System"
888356|NCT01123161|O1|Outcome|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888357|NCT01123161|E2|Reported Event|Group 2 : IV t-PA and Hypothermia and Anti-shivering Treatment|"IV tpa and hypothermia and anti-shivering treatment~hypothermia: Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming."
888358|NCT01123161|E1|Reported Event|Group1: IV t-PA and Normothermia|"IV tpa and normothermia~Group1: IV t-PA and normothermia: Group 1 will t-PA as standard of care and normothermia"
888359|NCT01123148|B1|Baseline|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
888360|NCT01123148|P1|Participant Flow|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
888361|NCT01123148|O1|Outcome|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
888362|NCT01123148|E1|Reported Event|Tilt Testing|Using a BCI to control wheelchair tilt: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
888363|NCT01122927|B1|Baseline|All Study Participants|Participants who entered open-label treatment phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888364|NCT01122927|P2|Participant Flow|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888365|NCT01122927|P1|Participant Flow|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continued to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
888366|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888367|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888368|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888369|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888370|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888371|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888372|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888373|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888374|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888375|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888376|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888377|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888378|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888379|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888380|NCT01122927|O5|Outcome|Tanner Score at Baseline of 5|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888381|NCT01122927|O4|Outcome|Tanner Score at Baseline of 4|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888382|NCT01122927|O3|Outcome|Tanner Score at Baseline of 3|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888383|NCT01122927|O2|Outcome|Tanner Score at Baseline of 2|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888384|NCT01122927|O1|Outcome|Tanner Score at Baseline of 1|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888385|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888386|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888387|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
889137|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
888388|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888389|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888390|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888391|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888392|NCT01122927|O1|Outcome|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888393|NCT01122927|E2|Reported Event|Open-label Treatment Phase|Participants who entered this phase had received oral aripiprazole at a target dose of 10 to 30 mg/day, with a minimum dose of 5 mg/day, based on individual participant's response and tolerability considerations.
888394|NCT01122927|E1|Reported Event|Conversion Phase|Participants who entered this phase were converted from his or her antipsychotic to the minimum target dose of 10 mg/day aripiprazole monotherapy and continue to increase the dose up to a maximum of 30 mg/day, or for tolerability reasons, to reduce the aripiprazole dose to no less than 5 mg/day.
888395|NCT01122901|B3|Baseline|Total|Total of all reporting groups
888396|NCT01122901|B2|Baseline|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888397|NCT01122901|B1|Baseline|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
888398|NCT01122901|P2|Participant Flow|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888399|NCT01122901|P1|Participant Flow|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
888400|NCT01122901|O3|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888401|NCT01122901|O2|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
888402|NCT01122901|O1|Outcome|Group A (Post Surgery) & Group B (Pre-surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~GROUP B Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888403|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888404|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888405|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888425|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888406|NCT01122901|O1|Outcome|Group A (Post Surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888407|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888408|NCT01122901|O1|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
888409|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888410|NCT01122901|O1|Outcome|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
888411|NCT01122901|O1|Outcome|Group B (Gamma-secretase Inhibitor RO4929097, Surgery)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888412|NCT01122901|O2|Outcome|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888413|NCT01122901|O1|Outcome|Group A (Post Surgery) & Group B (Pre-surgery) RO4929097 PO|"GROUP A Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies~GROUP B Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888414|NCT01122901|E2|Reported Event|Group B RO4929097 Pre Surgery|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days -6 to -1. Patients undergo surgical resection on day 0. Within 30 days after surgical resection, patients receive gamma-secretase inhibitor RO4929097 as in group A.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~therapeutic conventional surgery: Undergo surgery~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
888415|NCT01122901|E1|Reported Event|Group A RO4929097 PO|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO QD on days 1-3, 8-10, 15-17, and 22-24. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~pharmacological study: Correlative studies"
888416|NCT01122862|B1|Baseline|All Randomized Participants|All randomized participants were included for baseline parameters evaluation.
888417|NCT01122862|P3|Participant Flow|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888418|NCT01122862|P2|Participant Flow|Chlorhexidine Mouth Rinse (0.12%)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% weight by volume (w/v) chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888419|NCT01122862|P1|Participant Flow|Test Mouth Rinse|Participants swirled their oral cavity with 15 milliliters (mL) of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888420|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888421|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888422|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888423|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888424|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
890148|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
888426|NCT01122862|O3|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888427|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888428|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888429|NCT01122862|O2|Outcome|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888430|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888431|NCT01122862|O2|Outcome|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888432|NCT01122862|O1|Outcome|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888433|NCT01122862|E3|Reported Event|Sterile Water|Participants swirled their oral cavity with 15 mL of sterile water for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888434|NCT01122862|E2|Reported Event|Chlorhexidine Mouth Rinse (0.12% w/v)|Participants swirled their oral cavity with 15 mL of commercially available 0.12% w/v chlorhexidine mouth rinse for 30 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888435|NCT01122862|E1|Reported Event|Test Mouth Rinse|Participants swirled their oral cavity with 15 mL of commercially available test mouth rinse for 60 seconds and expectorated. Each treatment was administered twice daily for 4 days.
888436|NCT01122680|B1|Baseline|Total.|Total number of patients randomised and treated at all in the study.
888437|NCT01122680|P4|Participant Flow|Tio R2.5/Tio R1.25/Placebo|Patients treated with Tiotropium 2.5 mcg in Phase I, with Tiotropium 1.25 mcg in Phase II and with a matching Placebo in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
888438|NCT01122680|P3|Participant Flow|Placebo/Tio R2.5/Tio R5|Patients treated with a matching Placebo in Phase I, with Tiotropium 2.5 mcg in Phase II and with Tiotropium 5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
888439|NCT01122680|P2|Participant Flow|Tio R1.25/Tio R5/Tio R2.5|Patients treated with Tiotropium 1.25 mcg in Phase I, with Tiotropium 5 mcg in Phase II and with Tiotropium 2.5 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
888440|NCT01122680|P1|Participant Flow|Tio R5/Placebo/Tio R1.25|Patients treated with Tiotropium 5 mcg in Phase I, with a matching Placebo in Phase II and with Tiotropium 1.25 mcg in Phase III. All products were administered once daily (QD) in the evening, delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication. No washouts (off-treatment periods) between treatments.
888441|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888442|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888443|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888444|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888445|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888446|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888447|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888448|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888449|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888450|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888451|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888452|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888453|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888454|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
895526|NCT01104584|O1|Outcome|CMRM Versus UMRM|
888455|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888456|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888457|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888458|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888459|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888460|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888461|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888462|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888463|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888464|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888465|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888466|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888467|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888468|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888469|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888470|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888471|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888472|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888473|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888474|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888475|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888476|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888477|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888478|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888479|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888480|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888481|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888482|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888483|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888484|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888485|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888486|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888487|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
889138|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
888488|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888489|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888490|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888491|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888492|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888493|NCT01122680|O4|Outcome|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888494|NCT01122680|O3|Outcome|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888495|NCT01122680|O2|Outcome|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888496|NCT01122680|O1|Outcome|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888497|NCT01122680|E4|Reported Event|Tio R5|Tiotropium 5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888498|NCT01122680|E3|Reported Event|Tio R2.5|Tiotropium 2.5 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888499|NCT01122680|E2|Reported Event|Tio R1.25|Tiotropium 1.25 microgram once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888500|NCT01122680|E1|Reported Event|Placebo|Placebo once daily (QD) in the evening delivered by the Respimat® inhaler, on top on maintenance therapy with an inhaled corticosteroid controller medication.
888501|NCT01122576|B4|Baseline|Total|Total of all reporting groups
888502|NCT01122576|B3|Baseline|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888503|NCT01122576|B2|Baseline|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888504|NCT01122576|B1|Baseline|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888505|NCT01122576|P3|Participant Flow|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL :Tecnis surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
888506|NCT01122576|P2|Participant Flow|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
888507|NCT01122576|P1|Participant Flow|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally with 2 weeks between surgeries. Study observation up to 180 days."
888508|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888509|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888510|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888511|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888512|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888513|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888514|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888515|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888516|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888517|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
895527|NCT01104584|O1|Outcome|CMRM|
888518|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888519|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888520|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888521|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888522|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888523|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888524|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888525|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888526|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888527|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888528|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888529|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888530|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888531|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888532|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888533|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888534|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888535|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888536|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888537|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888538|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888539|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888540|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888541|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888542|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888543|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888544|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888545|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
895528|NCT01104584|O1|Outcome|CMRM|
888546|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888547|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888548|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888549|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888550|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888551|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888552|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888553|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888554|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888555|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888556|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888557|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888558|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888559|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888560|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888561|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888562|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888563|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888564|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888565|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888566|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888567|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888568|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888569|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888570|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888571|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888572|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888573|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888574|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888575|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888576|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888577|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888578|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888579|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888580|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888581|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888582|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888583|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888584|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888585|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888586|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888587|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888588|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888589|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888590|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888591|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888592|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888593|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888594|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888595|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888596|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888597|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888598|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888599|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888600|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888601|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888602|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888603|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888604|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888605|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888606|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888607|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888608|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888609|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888610|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888611|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888612|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888613|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888614|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and wer implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888615|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888616|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888617|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888618|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888619|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888620|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888621|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888622|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888623|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888624|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888625|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888626|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888627|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888628|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888629|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
895529|NCT01104584|O1|Outcome|CMRM|
888630|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888631|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888632|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888633|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888634|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888635|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888636|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888637|NCT01122576|O3|Outcome|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888638|NCT01122576|O2|Outcome|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888639|NCT01122576|O1|Outcome|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888640|NCT01122576|E3|Reported Event|Tecnis Multifocal IOL|"Eligible subjects underwent small incision cataract surgery and were implanted with the Tecnis Multifocal IOL bilaterally.~Tecnis Multifocal IOL : Tecnis surgically implanted bilaterally. Study observation up to 180 days."
888641|NCT01122576|E2|Reported Event|ReSTOR|"Eligible subjects underwent small incision cataract surgery and were implanted with the ReSTOR IOL bilaterally.~ReSTOR AOL : ReSTOR surgically implanted bilaterally. Study observation up to 180 days."
888642|NCT01122576|E1|Reported Event|Crystalens AO|"Eligible subjects underwent small incision cataract surgery and were implanted with the Crystalens AO bilaterally.~Crystalens AO : Crystalens AO surgically implanted bilaterally. Study observation up to 180 days."
888643|NCT01122511|B3|Baseline|Total|Total of all reporting groups
888644|NCT01122511|B2|Baseline|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
888645|NCT01122511|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
888646|NCT01122511|P2|Participant Flow|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
888647|NCT01122511|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
888648|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
888649|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
888650|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
888651|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
888652|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
888653|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
888654|NCT01122511|O2|Outcome|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
888655|NCT01122511|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
888656|NCT01122511|E2|Reported Event|Ranibizumab and Sham|Intravitreal injection of ranibizumab and sham into study eye.
888657|NCT01122511|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of 700 μg dexamethasone and ranibizumab into study eye.
888658|NCT01122394|B3|Baseline|Total|Total of all reporting groups
888659|NCT01122394|B2|Baseline|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
888660|NCT01122394|B1|Baseline|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
888661|NCT01122394|P2|Participant Flow|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
888662|NCT01122394|P1|Participant Flow|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
888663|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
888664|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
888665|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
888666|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
888667|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
890149|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
888668|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
888669|NCT01122394|O2|Outcome|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
888670|NCT01122394|O1|Outcome|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
888671|NCT01122394|O2|Outcome|Attention Placebo (AP)|"Attention Placebo~AP: Attention placebo"
888672|NCT01122394|O1|Outcome|Tailored Intervention (TI)|"Tailored intervention based on the transtheoretical model~TI: Tailored intervention based on the transtheoretical model"
888673|NCT01122394|E2|Reported Event|Attention Placebo (AP)|General phone counseling about health topics unrelated to stroke risk factors (e.g., pain, colorectal cancer screening)
888674|NCT01122394|E1|Reported Event|Tailored Intervention (TI)|Tailored phone intervention targeting diet, exercise, and medication adherence based on the transtheoretical model
888675|NCT01122381|B3|Baseline|Total|Total of all reporting groups
888676|NCT01122381|B2|Baseline|Arm 2|"placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
888677|NCT01122381|B1|Baseline|Arm 1|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
888678|NCT01122381|P2|Participant Flow|Arm 2-placebo|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~placebo comparator: placebo same size blinded capsules as the 250mg ESX; similar titration up to 4 capsules qd (expected) or 5 or 6 capsules for efficacy (not to exceed 30mg/kg/d) vs maximum tolerability"
888679|NCT01122381|P1|Participant Flow|Arm 1-drug Treatment|"migraineurs with 4-14 headache days per month that meet all inclusion/exclusion criteria~ethosuximide: ethosuximide (ESX) 250mg blinded capsules; begin 250mg qd titrating up to 1000mg qd (expected) or 1250mg qd, or 1500mg qd /30mg/kg/d maximum for efficacy goal of < 50% reduction in headache days versus maximum tolerability"
888680|NCT01122381|O2|Outcome|Arm 2-placebo Comparator|Study was terminated early-no outcome data available. Only one subject was assigned to study placebo but was dis-enrolled after titration phase due to study termination.
888681|NCT01122381|O1|Outcome|Arm 1-ethosuximide|Study was terminated early-no outcome data available. Only one subject was assigned to study drug arm but did not actually take it according to subsequent review of ESX drug levels.
888682|NCT01122381|E2|Reported Event|Arm 2- Placebo Comparator|"placebo blinded capsules of 250mg; subject was titrated up to 4 capsules qd"
888683|NCT01122381|E1|Reported Event|Arm 1- Ethosuximide|ethosuximide blinded capsules of 250mg ESX; subject was titrated up to 4 capsules qd
888684|NCT01122264|B4|Baseline|Total|Total of all reporting groups
888685|NCT01122264|B3|Baseline|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888686|NCT01122264|B2|Baseline|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888687|NCT01122264|B1|Baseline|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888688|NCT01122264|P3|Participant Flow|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888689|NCT01122264|P2|Participant Flow|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888690|NCT01122264|P1|Participant Flow|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888691|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888692|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888693|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888694|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888695|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888696|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888697|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888698|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888699|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888700|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888702|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888703|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888704|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888705|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888706|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888707|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888708|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888709|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888710|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888711|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888712|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888713|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888714|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888715|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
888716|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.
888717|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).
888718|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888719|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888720|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888721|NCT01122264|O1|Outcome|Entire Study Population|"Tadalafil On Demand: Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day).~Tadalafil Once a Day: Participants were instructed to take a 5-mg or 2.5-mg tadalafil tablet orally, once a day.~Sildenafil Citrate On Demand: Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day)."
888722|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888723|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888724|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888725|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888726|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888727|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888728|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888729|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888730|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888731|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888732|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
895530|NCT01104584|O1|Outcome|CMRM Versus UMRM|
888733|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888734|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888735|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888736|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888737|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888738|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888739|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888740|NCT01122264|O3|Outcome|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888741|NCT01122264|O2|Outcome|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888742|NCT01122264|O1|Outcome|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888743|NCT01122264|E3|Reported Event|Sildenafil Citrate On Demand|Participants were instructed to take a 50-mg, 100-mg, or 25-mg tablet of sildenafil citrate orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888744|NCT01122264|E2|Reported Event|Tadalafil Once a Day|Participants were instructed to take a 5-mg or 2.5-mg tablet of tadalafil orally once a day for 24 weeks.
888745|NCT01122264|E1|Reported Event|Tadalafil On Demand|Participants were instructed to take a 10-milligram (mg) or 20-mg tablet of tadalafil orally on demand, with a maximum of 4 tablets per week (and no more than 1 tablet per day) for 24 weeks.
888746|NCT01122238|B17|Baseline|Total|Total of all reporting groups
888747|NCT01122238|B16|Baseline|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888748|NCT01122238|B15|Baseline|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888749|NCT01122238|B14|Baseline|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888750|NCT01122238|B13|Baseline|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888751|NCT01122238|B12|Baseline|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888752|NCT01122238|B11|Baseline|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888753|NCT01122238|B10|Baseline|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888754|NCT01122238|B9|Baseline|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888755|NCT01122238|B8|Baseline|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888756|NCT01122238|B7|Baseline|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888757|NCT01122238|B6|Baseline|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888758|NCT01122238|B5|Baseline|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888759|NCT01122238|B4|Baseline|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888760|NCT01122238|B3|Baseline|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888827|NCT01122030|P4|Participant Flow|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888761|NCT01122238|B2|Baseline|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888762|NCT01122238|B1|Baseline|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888763|NCT01122238|P16|Participant Flow|16, No Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888764|NCT01122238|P15|Participant Flow|15, No Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888765|NCT01122238|P14|Participant Flow|14, No Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888766|NCT01122238|P13|Participant Flow|13, No Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888767|NCT01122238|P12|Participant Flow|12, No Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888768|NCT01122238|P11|Participant Flow|11, No Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888769|NCT01122238|P10|Participant Flow|10, No Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888770|NCT01122238|P9|Participant Flow|9, No Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? No Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888771|NCT01122238|P8|Participant Flow|8, Nicotine Patch, No Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888772|NCT01122238|P7|Participant Flow|7, Nicotine Patch, No Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888773|NCT01122238|P6|Participant Flow|6, Nicotine Patch, No Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888774|NCT01122238|P5|Participant Flow|5, Nicotine Patch, No Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, No Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888775|NCT01122238|P4|Participant Flow|4, Nicotine Patch, Nicotine Gum, No Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888776|NCT01122238|P3|Participant Flow|3, Nicotine Patch, Nicotine Gum, No Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, No Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888777|NCT01122238|P2|Participant Flow|2, Nicotine Patch, Nicotine Gum, Reduction, No MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and No Motivational Interviewing (MI)"
888778|NCT01122238|P1|Participant Flow|1, Nicotine Patch, Nicotine Gum, Reduction, MI|"This arm of the project will address the following question:~How effective is the following intervention? Nicotine Patch, Nicotine Gum, Smoking Reduction Counseling, and Motivational Interviewing (MI)"
888779|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
888780|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
888781|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
888782|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
888783|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
888784|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
888785|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
888786|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
888787|NCT01122238|O8|Outcome|No Motivational Interviewing|All participants in this group received No Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The No Motivational Interviewing group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding Motivational Interviewing group consisting of 253 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
888788|NCT01122238|O7|Outcome|Motivational Interviewing|All participants in this group received Motivational Interviewing counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Smoking Reduction or No Smoking Reduction). The Motivational Interviewing group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding No Motivational Interviewing group consisting of 264 participants (approximately half of the total study sample) in a main effect (Motivational Interviewing versus No Motivational Interviewing) statistical comparison.
888789|NCT01122238|O6|Outcome|No Smoking Reduction|All participants in this group received No Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The No Smoking Reduction group consists of 257 participants (approximately half of the total study sample) and will be compared to a corresponding Smoking Reduction group consisting of 260 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
888790|NCT01122238|O5|Outcome|Smoking Reduction|All participants in this group received Smoking Reduction counseling; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing). The Smoking Reduction group consists of 260 participants (approximately half of the total study sample) and will be compared to a corresponding No Smoking Reduction group consisting of 257 participants (approximately half of the total study sample) in a main effect (Smoking Reduction versus No Smoking Reduction) statistical comparison.
888791|NCT01122238|O4|Outcome|No Nicotine Gum|All participants in this group received No Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Gum group consists of 253 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Gum group consisting of 264 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
888792|NCT01122238|O3|Outcome|Nicotine Gum|All participants in this group received Nicotine Gum; the group includes participants who received combinations of the other three study interventions (Nicotine Patch or No Nicotine Patch; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Gum group consists of 264 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Gum group consisting of 253 participants (approximately half of the total study sample) in a main effect (Nicotine Gum versus No Nicotine Gum) statistical comparison.
888826|NCT01122030|P5|Participant Flow|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
890150|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
888793|NCT01122238|O2|Outcome|No Nicotine Patch|All participants in this group received No Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The No Nicotine Patch group consists of 252 participants (approximately half of the total study sample) and will be compared to a corresponding Nicotine Patch group consisting of 265 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
888794|NCT01122238|O1|Outcome|Nicotine Patch|All participants in this group received Nicotine Patch; the group includes participants who received combinations of the other three study interventions (Nicotine Gum or No Nicotine Gum; Motivational Interviewing or No Motivational Interviewing); Smoking Reduction or No Smoking Reduction). The Nicotine Patch group consists of 265 participants (approximately half of the total study sample) and will be compared to a corresponding No Nicotine Patch group consisting of 252 participants (approximately half of the total study sample) in a main effect (Nicotine Patch versus No Nicotine Patch) statistical comparison.
888795|NCT01122238|E4|Reported Event|No Medication|"No Medication~Participants randomized to this condition received no medication."
888796|NCT01122238|E3|Reported Event|Prequit Nicotine Gum Only|"Prequit Nicotine Gum Only.~Participants randomized to this condition received a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks."
888797|NCT01122238|E2|Reported Event|Prequit Nicotine Patch Only|"Prequit Nicotine Patch Only~Participants randomized to this condition received a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks."
888798|NCT01122238|E1|Reported Event|Prequit Combined Nicotine Patch + Gum|"Prequit Combined Nicotine Patch + Gum~Participants randomized to this condition received a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks."
888799|NCT01122160|B1|Baseline|All Study Participants|All participants received both interventions.
888800|NCT01122160|P2|Participant Flow|Omeprazole First, Then Placebo|Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries), followed by placebo with berries (blackberries + strawberries)
888801|NCT01122160|P1|Participant Flow|Placebo First, Then Omeprazole|Placebo with berries (blackberries + strawberries), followed by Omeprazole with berries (blackberries + strawberries)
888802|NCT01122160|O2|Outcome|Placebo|
888803|NCT01122160|O1|Outcome|Experimental|
888804|NCT01122160|E2|Reported Event|Placebo|
888805|NCT01122160|E1|Reported Event|Experimental|
888806|NCT01122108|B1|Baseline|Colesevelam HCl (3.75g) vs Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
888807|NCT01122108|P2|Participant Flow|Cholestyramine 12g First, Then Colesevelam HCl 3.75|Cholestyramine 12g once orally in the first intervention and Colesevelam 3.75g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
888808|NCT01122108|P1|Participant Flow|Colesevelam HCl 3.75g First, Then Cholestyramine 12g|Colesevelam HCl 3.75g once orally in the first intervention and Cholestyramine 12g once orally in the second intervention. Both interventions were given on the same day, 30 minutes apart.
888809|NCT01122108|O2|Outcome|Cholestyramine (12g)|
888810|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
888811|NCT01122108|O2|Outcome|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
888812|NCT01122108|O1|Outcome|Colesevelam HCl (3.75g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
888813|NCT01122108|E3|Reported Event|More Than 30 Minutes After Last Beverage|This group summarizes the adverse events that occurred more than 30 mintures after the last beverage administered, and thus cannot be attributed to one specific bile acid sequestrant.
888814|NCT01122108|E2|Reported Event|Colesevelam HCl (3.75 Grams)|
888815|NCT01122108|E1|Reported Event|Cholestyramine (12g)|Although 2 different arms are used in this study, there is only one study group. All subjects received both treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for both arms.
888816|NCT01122030|B8|Baseline|Total|Total of all reporting groups
888817|NCT01122030|B7|Baseline|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888818|NCT01122030|B6|Baseline|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888819|NCT01122030|B5|Baseline|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888820|NCT01122030|B4|Baseline|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888821|NCT01122030|B3|Baseline|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888822|NCT01122030|B2|Baseline|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888823|NCT01122030|B1|Baseline|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888824|NCT01122030|P7|Participant Flow|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888825|NCT01122030|P6|Participant Flow|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
890151|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
888828|NCT01122030|P3|Participant Flow|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888829|NCT01122030|P2|Participant Flow|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888830|NCT01122030|P1|Participant Flow|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888831|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888832|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888833|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888834|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888835|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888836|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888837|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888838|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888839|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888840|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888841|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888842|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888843|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888844|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888845|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888846|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888847|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888848|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888849|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888850|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888851|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888852|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888853|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888854|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888855|NCT01122030|O6|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888856|NCT01122030|O5|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888857|NCT01122030|O4|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888858|NCT01122030|O3|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888859|NCT01122030|O2|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888860|NCT01122030|O1|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888861|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888862|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888863|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888864|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888865|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888866|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888867|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888868|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888869|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
889139|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
888870|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888871|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888872|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888873|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888874|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888875|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888876|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888877|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888878|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888879|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888880|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888881|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888882|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888883|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888884|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888885|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888886|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888887|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888888|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888889|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888890|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888891|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888892|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888893|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888894|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888895|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888896|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888897|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888898|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888899|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888900|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888901|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888902|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888903|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888904|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888905|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888906|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888907|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888908|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888909|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888910|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888911|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888912|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888913|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888914|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888915|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888916|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888917|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888918|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888919|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888920|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888921|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888922|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888923|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888924|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888925|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888926|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888927|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888928|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888929|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888930|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888931|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888932|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888933|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888934|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888935|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888936|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888937|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888938|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888939|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888940|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888941|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888942|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888943|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888944|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888945|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888946|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888947|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888948|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888949|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888950|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888951|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888952|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888953|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888954|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888955|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888956|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888957|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888958|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888959|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888960|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888961|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888962|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888963|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888964|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888965|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888966|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888967|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888968|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888969|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888970|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888971|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888972|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888973|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888974|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888975|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888976|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888977|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888978|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888979|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888980|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888981|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888982|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888983|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888984|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888985|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888986|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888987|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888988|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888989|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888990|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888991|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888992|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888993|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
888994|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888995|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
888996|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
888997|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
888998|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
888999|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
889000|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
889001|NCT01122030|O7|Outcome|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
889002|NCT01122030|O6|Outcome|Naldemedine 1 mg|Participants received a single dose of 1 mg naldemedine tablets administered on Day 15 under fasted conditions.
889003|NCT01122030|O5|Outcome|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
889004|NCT01122030|O4|Outcome|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
889005|NCT01122030|O3|Outcome|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
889006|NCT01122030|O2|Outcome|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
889007|NCT01122030|O1|Outcome|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
889008|NCT01122030|E7|Reported Event|Naldemedine 3 mg|Participants received a single dose of 3 mg naldemedine tablets administered on Day 15 under fasted conditions.
889009|NCT01122030|E6|Reported Event|Naldemedine 1 mg|Participants received a single dose of 1mg naldemedine tablets administered on Day 15 under fasted conditions.
889010|NCT01122030|E5|Reported Event|Naldemedine 0.3 mg|Participants received a single dose of 0.3 mg naldemedine tablets administered on Day 15 under fasted conditions.
889011|NCT01122030|E4|Reported Event|Naldemedine 0.1 mg|Participants received one 0.1 mg naldemedine tablet administered on Day 15 under fasted conditions.
889012|NCT01122030|E3|Reported Event|Naldemedine 0.03 mg|Participants received a single dose of 0.03 mg naldemedine oral solution administered on Day 15 under fasted conditions.
889013|NCT01122030|E2|Reported Event|Naldemedine 0.01 mg|Participants received a single dose of 0.01 mg naldemedine oral solution administered on Day 15 under fasted conditions.
889014|NCT01122030|E1|Reported Event|Pooled Placebo|Participants received a single dose of matching placebo administered orally on Day 15 under fasted conditions.
889015|NCT01121991|B1|Baseline|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889016|NCT01121991|P1|Participant Flow|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889017|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889018|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889019|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889020|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889021|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889022|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889023|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889024|NCT01121991|O1|Outcome|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889025|NCT01121991|E1|Reported Event|Recombinant Human-Luteinizing Hormone (Luveris)|All participants received Luveris 150 International Unit (IU) per day, subcutaneously (s.c) from stimulation day 6 (Day S6) of their assisted reproductive technology (ART) treatment cycle, continuing at the same dose until injection of hCG upto and including day of last FSH dose.
889049|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889050|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889026|NCT01121939|B1|Baseline|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
889027|NCT01121939|P1|Participant Flow|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
889028|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
889029|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
889030|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
889031|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
889032|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
889033|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
889034|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
889035|NCT01121939|O1|Outcome|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
889036|NCT01121939|O3|Outcome|All Patients|All patients on study (treatment is same for all patients)
889037|NCT01121939|O2|Outcome|Pancreatic Islet Cell|Patients with pancreatic islet cell disease
889038|NCT01121939|O1|Outcome|Typical Carcinoid|Patients with typical carcinoid disease
889039|NCT01121939|E1|Reported Event|All Patients|"Bevacizumab: 15 mg/kg IV Day 1. The first dose should be administered over~90 minutes. If no adverse reactions occur after the initial dose, the second dose should~be administered over a minimum of 60 minutes. If no adverse reactions occur after the~second dose, all subsequent doses should be administered over a minimum of 30~minutes. Bevacizumab will be infused prior to pertuzumab.~Pertuzumab: 840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes.~Sandostatin LAR® Depot: 30 mg will be given every 28 days by IM injection."
889040|NCT01121926|B1|Baseline|Entire Study Population|"Includes groups randomized to receive Trazodone Contramid® OAD (Once-A-Day) test product first and Trazodone IR (Apotex Corp.) reference product first.~IR = Immediate Release"
889041|NCT01121926|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
889042|NCT01121926|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet administered once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in the second treatment phase. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.~IR = Immediate Release."
889043|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889044|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889045|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889046|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889047|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889048|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889051|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889052|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889053|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889054|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889055|NCT01121926|O2|Outcome|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889056|NCT01121926|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889057|NCT01121926|E2|Reported Event|Trazodone HCl (Apotex Corp.)|Trazodone HCl (Apotex Corp.) reference product (100 mg tablet administered thrice daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889058|NCT01121926|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either period. A drug-free period of 7 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889059|NCT01121913|B1|Baseline|Entire Study Population|Includes groups randomized to receive Trazodone Contramid® OAD (prototype 1) First, Trazodone Contramid® OAD (prototype 2) First, Triticco® First, and Desyrel® First.
889060|NCT01121913|P4|Participant Flow|Desyrel® First|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase I; followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase II; 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
889061|NCT01121913|P3|Participant Flow|Triticco® First|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase I; followed by 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase III; and 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
889062|NCT01121913|P2|Participant Flow|Trazodone Contramid® OAD (Prototype 2) First|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase I, followed by 1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase II; 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase III; and 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
889063|NCT01121913|P1|Participant Flow|Trazodone Contramid® OAD (Prototype 1) First|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in treatment phase I; followed by 2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in treatment phase II; 1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in treatment phase III; and 3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in treatment phase IV. There was a washout period of 7 days between treatment phases.
889064|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
889065|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
889066|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
889067|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
889068|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
889069|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
889070|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
889071|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
889072|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
889073|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
889074|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
889075|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
889076|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
889077|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
889078|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
889079|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
889080|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
889081|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
889082|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
889083|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
889084|NCT01121913|O4|Outcome|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
889085|NCT01121913|O3|Outcome|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
889086|NCT01121913|O2|Outcome|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
889087|NCT01121913|O1|Outcome|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
889088|NCT01121913|E4|Reported Event|Desyrel®|3 * 100 mg Desyrel® tablets (at 07:30, 15:30 and 23:30) reference product dosed in either treatment phase.
889089|NCT01121913|E3|Reported Event|Triticco®|2 * 150 mg Triticco® tablets (at 07:30 and 19:30) reference product dosed in either treatment phase.
889090|NCT01121913|E2|Reported Event|Trazodone Contramid® OAD (Prototype 2)|1 * 300 mg Trazodone Contramid® OAD (prototype 2) tablet test product dosed in either treatment phase.
889091|NCT01121913|E1|Reported Event|Trazodone Contramid® OAD (Prototype 1)|1 * 300 mg Trazodone Contramid® OAD (prototype 1) tablet test product dosed in either treatment phase.
889092|NCT01121900|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
889093|NCT01121900|P2|Participant Flow|Reference (Trazodone IR [Apotex Corp.]) First|"Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in first treatment phase followed by Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
889094|NCT01121900|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"Trazodone Contramid® OAD (Once-A-Day) test product (300 mg tablet once daily) dosed in first treatment phase followed by Trazodone IR (Apotex Corp.) reference product (100 mg tablet thrice daily) dosed in the second treatment phase. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in treatment period 1 and the first administration of study medication in treatment period 2.~IR = Immediate Release."
889095|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889096|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889097|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889098|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889099|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889100|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889101|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889102|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889103|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889104|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889105|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889106|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889107|NCT01121900|O2|Outcome|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889108|NCT01121900|O1|Outcome|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889109|NCT01121900|E2|Reported Event|Trazodone IR (Apotex Corp.)|Trazodone IR (Apotex Corp.) reference product (100 mg tablet administered thrice daily)dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889110|NCT01121900|E1|Reported Event|Trazodone Contramid® OAD|Trazodone Contramid® OAD test product (300 mg tablet administered once daily) dosed in either first intervention period or second intervention period. A drug-free period of 7 to 14 calendar days separated the last administration of study medication in Phase 1 and the first administration of study medication in Phase 2.
889111|NCT01121757|B3|Baseline|Total|Total of all reporting groups
889112|NCT01121757|B2|Baseline|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889113|NCT01121757|B1|Baseline|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889114|NCT01121757|P2|Participant Flow|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889115|NCT01121757|P1|Participant Flow|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889116|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889117|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889118|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889119|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889120|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889121|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889122|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889123|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889124|NCT01121757|O2|Outcome|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889125|NCT01121757|O1|Outcome|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a Complete Remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889126|NCT01121757|E2|Reported Event|1b-Lenalidomide Followed by Azacitidine|"Subjects will take lenalidomide for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of lenalidomide (first drug) will proceed to receive azacitidine (second drug) for 4-6 cycles.~Subjects with a CR after azacitidine may receive up to 6 cycles of azacitidine and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889127|NCT01121757|E1|Reported Event|1a-Azacitidine Followed by Lenalidomide|"Subjects will take azacitidine for 4-6 cycles (first drug) followed by a 1-6 week washout period. Subjects with a complete remission (CR) may receive up to 6 cycles of first drug and will not receive the next until disease progression.~Subjects with less than a CR after 4 cycles of azacitidine (first drug) will proceed to receive lenalidomide (second drug) for 4-6 cycles.~Subjects with a CR after lenalidomide may receive up to 6 cycles of lenalidomide and will not start on the combination drug until disease progression.~The combination therapy (azacitidine and lenalidomide) will be given in 28-day cycles for up to 13 cycles in subjects who have stable disease or better."
889128|NCT01121666|B3|Baseline|Total|Total of all reporting groups
889129|NCT01121666|B2|Baseline|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889130|NCT01121666|B1|Baseline|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889131|NCT01121666|P2|Participant Flow|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889132|NCT01121666|P1|Participant Flow|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889133|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889134|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889140|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889141|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889142|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889143|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889144|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889145|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889146|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889147|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889148|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889149|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889150|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889151|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889152|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889153|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889154|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889155|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889156|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889157|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889158|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889159|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889160|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889161|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889162|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889163|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889164|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889165|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889166|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889167|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889168|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889169|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889170|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889171|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889172|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889173|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889174|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889175|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889176|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889177|NCT01121666|O2|Outcome|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889178|NCT01121666|O1|Outcome|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889179|NCT01121666|E2|Reported Event|Gonal-f® (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889180|NCT01121666|E1|Reported Event|AFOLIA-150 (Follitropin Alfa)|Follitropin alfa: 150IU per day subcutaneously for a maximum of 16 days
889181|NCT01121575|B7|Baseline|Total|Total of all reporting groups
889182|NCT01121575|B6|Baseline|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889183|NCT01121575|B5|Baseline|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889369|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889184|NCT01121575|B4|Baseline|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889185|NCT01121575|B3|Baseline|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889186|NCT01121575|B2|Baseline|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889187|NCT01121575|B1|Baseline|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889188|NCT01121575|P6|Participant Flow|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889189|NCT01121575|P5|Participant Flow|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889190|NCT01121575|P4|Participant Flow|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889191|NCT01121575|P3|Participant Flow|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889192|NCT01121575|P2|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889193|NCT01121575|P1|Participant Flow|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg twice a day (BID) and oral dacomitinib 30 mg once daily (QD). The first cycle was for 28 days thereafter, each cycle was 21 days.
889194|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
889195|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
889196|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
889197|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
889198|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
889199|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
889200|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
889201|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
889202|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
889203|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
889204|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 2)|Participants who progressed on dacomitinib were changed from single agent dacomitinib at the prevailing dose to combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles) as soon as feasible, and no later than 28 days after documentation of disease progression. The participants in this group received 30 mg QD doses of dacomitinib in combination with 200 mg BID doses of crizotinib.
889205|NCT01121575|O1|Outcome|Dacomitinib Alone (Expansion Cohort 2)|Participants received dacomitinib (30 mg, QD) alone in 21-day cycles until disease progression.
895531|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
889206|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
889207|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
889208|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
889209|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
889210|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
889211|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
889212|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
889213|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
889214|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule. Each cycle was 21 days.
889215|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
889216|NCT01121575|O2|Outcome|Crizotinib + Dacomitinib (Expansion Cohort 1)|Participants received combined oral crizotinib (200 mg BID) and oral dacomitinib (30 mg QD) on a continuous daily schedule.
889217|NCT01121575|O1|Outcome|Crizotinib Alone (Expansion Cohort 1)|Participants received crizotinib alone continuous 200 mg BID dosing for approximately 12 days (±2 days).
889218|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889219|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889220|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889221|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889222|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889223|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889224|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889225|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889226|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889227|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889228|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889229|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889230|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889231|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889232|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889233|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889234|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889235|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889236|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889237|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889238|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889239|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889240|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889241|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889242|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889243|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889244|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889245|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889246|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889247|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889248|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889249|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889250|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889251|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889252|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889253|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889254|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889255|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889256|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889257|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889258|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889259|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889260|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889261|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889370|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
889262|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889263|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889264|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889265|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889266|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889267|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889268|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889269|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889270|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889271|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889272|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889273|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889293|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889274|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889275|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889276|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889277|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889278|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889279|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889280|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889281|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889282|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889283|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889284|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889285|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889286|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889287|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889288|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889289|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889290|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889291|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889292|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889294|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889295|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889296|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889297|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889298|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889299|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889300|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889301|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889302|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889303|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889304|NCT01121575|O2|Outcome|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889305|NCT01121575|O1|Outcome|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889306|NCT01121575|O4|Outcome|Crizotinib 250 mg QD/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889307|NCT01121575|O3|Outcome|Crizotinib 250 mg BID/ Dacomitinib 30 mg QD|Participants received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889308|NCT01121575|O2|Outcome|Crizotinib 200 mg BID/ Dacomitinib 45 mg QD|Participants received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889309|NCT01121575|O1|Outcome|Crizotinib 200 mg BID/ Dacomitinib 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg QD. The first cycle was for 28 days thereafter, each cycle was 21 days.
889310|NCT01121575|E6|Reported Event|Expansion Cohort 2|Participants were treated first with single agent dacomitinib at a dose determined by agreement between the investigator and the sponsor, and then, at progression, with combined maximum tolerated dose of crizotinib and dacomitinib (given orally on a continuous schedule in 21-day cycles of crizotinib 200 mg BID + dacomitinib 30 mg QD) as soon as feasible, and no later than 28 days after documentation of progressive disease. Expansion Cohort 2 used the same participant population as Expansion Cohort 1 and was designed to assess the clinical value of adding crizotinib to dacomitinib treatment after disease progression on dacomitinib alone.
889311|NCT01121575|E5|Reported Event|Expansion Cohort 1|Participants enrolled in expansion cohort 1 received combined oral crizotinib and oral dacomitinib on a continuous daily schedule of crizotinib 200 mg BID + dacomitinib 30 mg QD. Each cycle was 21 days. If there was unacceptable toxicity or tolerability the dose could be adjusted to a lower combined dose. Expansion Cohort 1 was designed to examine the safety of crizotinib and dacomitinib administered concomitantly in NSCLC participants with acquired resistance to erlotinib or gefitinib.
889312|NCT01121575|E4|Reported Event|PF-02341066, 250 mg QD/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
889313|NCT01121575|E3|Reported Event|PF-02341066, 250 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 250 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
889314|NCT01121575|E2|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 45 mg QD|Participants enrolled in dose escalation received combined oral crizotinib 200 mg BID and oral dacomitinib 45 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
895532|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
889315|NCT01121575|E1|Reported Event|PF-02341066, 200 mg BID/ PF-00299804, 30 mg QD|Participants enrolled in dose escalation phase received combined oral crizotinib 200 mg BID and oral dacomitinib 30 mg. The first cycle was for 28 days thereafter, each cycle was 21 days.
889316|NCT01121562|B1|Baseline|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889317|NCT01121562|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889318|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889319|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889320|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889321|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889322|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889323|NCT01121562|O1|Outcome|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889324|NCT01121562|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg was orally administered once daily in a continuous daily dosing regimen (1 cycle = 4 weeks).
889325|NCT01121549|B1|Baseline|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889326|NCT01121549|P1|Participant Flow|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889327|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889328|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889329|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889330|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889331|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889332|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889333|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889334|NCT01121549|O1|Outcome|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889335|NCT01121549|E1|Reported Event|Exemestane|Participants with 2 to 3 years of initial adjuvant tamoxifen therapy received exemestane (Aromasin) 25 milligram (mg) tablet orally once daily as per local standard of care to complete 5 years of adjuvant hormonal therapy.
889336|NCT01121536|B1|Baseline|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889337|NCT01121536|P1|Participant Flow|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889338|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889339|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889340|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889341|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889342|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889343|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889344|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889345|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889346|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889347|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889348|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889349|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889350|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889351|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889352|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889353|NCT01121536|O1|Outcome|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889354|NCT01121536|E1|Reported Event|Armodafinil 150-200 mg/Day|Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. At the discretion of the investigator, the dosage of armodafinil may be increased to 200 mg/day on day 6 or thereafter, and reduced to 150mg/day if the higher dose is not well tolerated. Treatment was administered for six months.
889355|NCT01121484|B3|Baseline|Total|Total of all reporting groups
889356|NCT01121484|B2|Baseline|Placebo|Matching placebo tablets once daily for 10 weeks
889357|NCT01121484|B1|Baseline|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889358|NCT01121484|P2|Participant Flow|Placebo|Matching placebo tablets once daily for 10 weeks
889359|NCT01121484|P1|Participant Flow|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889360|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
889361|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889362|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
889363|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889364|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
889365|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889366|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
889367|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889368|NCT01121484|O2|Outcome|Placebo|Matching placebo tablets once daily for 10 weeks
889371|NCT01121484|O1|Outcome|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889372|NCT01121484|E2|Reported Event|Placebo|Matching placebo tablets once daily for 10 weeks
889373|NCT01121484|E1|Reported Event|Desvenlafaxine Succinate|Desvenlafaxine succinate sustained-release (DVS SR) 50 milligram tablets once daily for 10 weeks
889374|NCT01121406|B3|Baseline|Total|Total of all reporting groups
889375|NCT01121406|B2|Baseline|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889376|NCT01121406|B1|Baseline|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889377|NCT01121406|P2|Participant Flow|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889378|NCT01121406|P1|Participant Flow|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889379|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889380|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889381|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889382|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889383|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889384|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889385|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889386|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889387|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889388|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889389|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889390|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889391|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889392|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889393|NCT01121406|O1|Outcome|Volasertib|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889394|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
889395|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889396|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889397|NCT01121406|O3|Outcome|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
889398|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889399|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889400|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889401|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889429|NCT01121393|P1|Participant Flow|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 milligram (mg) once daily (q.d.) orally with possible dose escalation to 50 mg q.d. and dose reduction to 40 mg q.d. (if applicable), 30 mg q.d., or 20 mg q.d. (according to the protocol-defined dose-escalation and dose-reduction scheme), if required. No dose increase was allowed after dose reduction.
889430|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
895533|NCT01104584|O1|Outcome|CMRM vs UMRM|
889402|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889403|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889404|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889405|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889406|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889407|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889408|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889409|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889410|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889411|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889412|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889413|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889414|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889415|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889416|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889417|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889418|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889419|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889420|NCT01121406|O2|Outcome|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889421|NCT01121406|O1|Outcome|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889422|NCT01121406|E3|Reported Event|Cytotoxic to Volasertib Switch|Patients of the cytotoxic arm who switched to treatment with Volasertib (BI 6727).
889423|NCT01121406|E2|Reported Event|Cytotoxic|"Patients received a non-platinum cytotoxic single agent. The investigator chose the most appropriate drug according to patient status (previous chemotherapy effects, cumulative toxic effects, performance status, and nutritional status), the product Summary of Product Characteristics (SPC), and the local standard of care. The following non-platinum regimens were recommended because they are regarded efficacious and safe in patients with resistant ovarian cancer:~Pegylated liposomal doxorubicin (PLD): 40 mg/m² at Day 1 (1 course = 28 days)~Topotecan: 1.25 mg/m² from Days 1 to 5 (1 course = 21 days), or 4 mg/m² at Days 1, 8, and 15 (1 course = 28 days)~Paclitaxel: 80 mg/m² at Days 1, 8, 15, and 21 (1 course = 28 days)~Gemcitabine: 1000 mg/m² at Days 1 and 8 (1 course = 21 days)"
889424|NCT01121406|E1|Reported Event|Volasertib (BI 6727)|"Volasertib (BI 6727 300 mg) was administered as intravenous infusion over 2 hours at Day 1 of each 21-day treatment course.~Treatment was to be administered until disease progression or occurrence of toxicity leading to treatment discontinuation. Patients withdrawn from volasertib treatment could receive a treatment according to investigator’s choice. The patients were to be followed for survival status."
889425|NCT01121393|B3|Baseline|Total|Total of all reporting groups
889426|NCT01121393|B2|Baseline|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889427|NCT01121393|B1|Baseline|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889428|NCT01121393|P2|Participant Flow|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 milligram per square metre (mg/m²) as an intravenous infusion over 30 minutes on day 1 and day 8, cisplatin (solution for infusion) 75 mg/m² as an intravenous infusion on Day 1 of each 21-day treatment course up to 6 cycles; Chemotherapy could be delayed or the dose could be reduced in accordance with the guidance in the current summary of product characteristics.
895534|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
889431|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889432|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889433|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889434|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
889435|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
889436|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
889437|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) after a dose escalation.
889438|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.)
889439|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) after a dose reduction.
889440|NCT01121393|O3|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib 50mg once daily (q.d.) orally after a dose escalation.
889441|NCT01121393|O2|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib 40mg once daily (q.d.) orally
889442|NCT01121393|O1|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib 30mg once daily (q.d.) orally after a dose reduction.
889443|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889444|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889445|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889446|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889447|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889448|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889449|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889450|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889451|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889452|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889453|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889454|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889455|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889456|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889457|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889458|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889459|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889460|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889461|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889462|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889463|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889464|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889465|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889466|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889467|NCT01121393|O2|Outcome|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889468|NCT01121393|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889469|NCT01121393|E2|Reported Event|Gemcitabine / Cisplatin Chemotherapy|Patients receiving Gemcitabine (lyophilised powder) 1000 mg/m² on day 1 and day 8, intravenous, cisplatin (solution for infusion) 75 mg/m² on day 1 of each 21-day treatment course up to 6 cycles
889470|NCT01121393|E1|Reported Event|Afatinib 40mg|Patients receiving Afatinib film-coated tablets 40 q.d., orally
889471|NCT01121263|B3|Baseline|Total|Total of all reporting groups
895535|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
889472|NCT01121263|B2|Baseline|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
889473|NCT01121263|B1|Baseline|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
889474|NCT01121263|P2|Participant Flow|Cohort 2: Intervention Cohort - PCI Group (N=98)|Patients who met proposed anatomic and clinical eligibility criteria and underwent multivessel Percutaneous Coronary Intervention (PCI) with drug eluting stents (DES)
889475|NCT01121263|P1|Participant Flow|Cohort 2: Intervention Cohort - HCR Group (N=200)|Patients who underwent Hybrid Coronary Revascularization (HCR) with minimally invasive LIMA-LAD CABG
889476|NCT01121263|O2|Outcome|PCI Group (N=98)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - PCI Group
889477|NCT01121263|O1|Outcome|HCR Group (N=200)|Occurrence of MACCE through the end of study in Cohort 2: Intervention Cohort - HCR Group
889478|NCT01121263|O2|Outcome|PCI Group (N=98)|Primary Outcome in Cohort 2: Intervention Cohort - PCI Group
889479|NCT01121263|O1|Outcome|HCR Group (N=200)|Primary Outcome in Cohort 2: Intervention Cohort - HCR Group
889480|NCT01121263|E2|Reported Event|PCI Group (N=98)|Serious Adverse Events in Cohort 2: Intervention Cohort - PCI Group
889481|NCT01121263|E1|Reported Event|HCR Group (N=200)|Serious Adverse Events in Cohort 2: Intervention Cohort - HCR Group
889482|NCT01121211|B3|Baseline|Total|Total of all reporting groups
889483|NCT01121211|B2|Baseline|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
889484|NCT01121211|B1|Baseline|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
889485|NCT01121211|P2|Participant Flow|Placebo|"Placebo x 24 weeks~Placebo: Placebo transdermal patch x 24 weeks"
889486|NCT01121211|P1|Participant Flow|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
889487|NCT01121211|O2|Outcome|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
889488|NCT01121211|O1|Outcome|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
889489|NCT01121211|O2|Outcome|Placebo|"Placebo x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
889490|NCT01121211|O1|Outcome|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks.~Placebo: Placebo transdermal patch x 24 weeks"
889491|NCT01121211|E2|Reported Event|Placebo|"Placebo x 24 weeks~Placebo: Placebo transdermal patch x 24 weeks"
889492|NCT01121211|E1|Reported Event|Testosterone|"Testosterone x 24 weeks~Testosterone: Testosterone 300mcg transdermal patch x 24 weeks."
889493|NCT01121185|B3|Baseline|Total|Total of all reporting groups
889494|NCT01121185|B2|Baseline|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889495|NCT01121185|B1|Baseline|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889496|NCT01121185|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889497|NCT01121185|P1|Participant Flow|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889498|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889499|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889500|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889501|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889520|NCT01121172|B1|Baseline|Obese|obese children and adolescents according to International Obesity Task Force criteria
889521|NCT01121172|P2|Participant Flow|Lean|lean children and adolescents matched for age and gender to the obese group
889502|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889503|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889504|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889505|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889506|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889507|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889508|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889509|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889510|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889511|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889512|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889513|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889514|NCT01121185|O2|Outcome|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889515|NCT01121185|O1|Outcome|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889516|NCT01121185|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|Eleven intravenous infusions of 0.9% sodium chloride administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889517|NCT01121185|E1|Reported Event|Experimental: MBL-HCV1|Eleven intravenous infusions of MBL-HCV1 (50 mg/kg) human monoclonal antibody administered during the first 14 days post-transplantation: three infusions were given on Day 0 (1-4 hours prior to anhepatic phase, during the anhepatic phase, and within 4-12 hours post-reperfusion), daily infusions were administered on days 1 through 7, and the final infusion was given on day 14 ± 2 post transplantation.
889518|NCT01121172|B3|Baseline|Total|Total of all reporting groups
889519|NCT01121172|B2|Baseline|Lean|lean children and adolescents matched for age and gender to the obese group
895536|NCT01104584|O1|Outcome|CMRM vs UMRM|
889522|NCT01121172|P1|Participant Flow|Obese|obese children and adolescents according to International Obesity Task Force criteria
889523|NCT01121172|O1|Outcome|Obese Group|Obese children and adolescents according to IOTF criteria
889524|NCT01121172|O2|Outcome|Lean|lean children and adolescents matched for age and gender to the obese group
889525|NCT01121172|O1|Outcome|Obese|obese children and adolescents according to International Obesity Task Force criteria
889526|NCT01121172|E2|Reported Event|Lean|lean children and adolescents matched for age and gender to the obese group
889527|NCT01121172|E1|Reported Event|Obese|obese children and adolescents according to International Obesity Task Force criteria
889528|NCT01121146|B3|Baseline|Total|Total of all reporting groups
889529|NCT01121146|B2|Baseline|Standard Enduron Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
889530|NCT01121146|B1|Baseline|Crosslinked Marathon Polyethylene|Total Hip Replacement : Comparison of Marathon and Enduron polyethylene
889531|NCT01121146|P2|Participant Flow|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
889532|NCT01121146|P1|Participant Flow|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
889533|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
889534|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and crosslinked polyethylene liner.
889535|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
889536|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
889537|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
889538|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
889539|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
889540|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
889541|NCT01121146|O2|Outcome|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
889542|NCT01121146|O1|Outcome|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
889543|NCT01121146|E2|Reported Event|Standard Enduron Polyethylene|Implanted with a metal femoral head and a non-crosslinked polyethylene liner.
889544|NCT01121146|E1|Reported Event|Crosslinked Marathon Polyethylene|Implanted with a metal femoral head and a crosslinked polyethylene liner.
889545|NCT01120990|B1|Baseline|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
889546|NCT01120990|P1|Participant Flow|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
889547|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
889548|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
889549|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
889550|NCT01120990|O1|Outcome|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device.
889551|NCT01120990|E1|Reported Event|All Patients|All patients included in the study with complete blood pressure measurements data consist a single group. The tested value is the degree of agreement between measurements performed with mercury devices and with the tested device
889552|NCT01120899|B1|Baseline|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889553|NCT01120899|P1|Participant Flow|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889554|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889555|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889556|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889557|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889558|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889559|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889560|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889561|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889562|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889563|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889564|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889565|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889566|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889567|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889568|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889569|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889570|NCT01120899|O1|Outcome|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889571|NCT01120899|E1|Reported Event|Minocycline|Participants take an oral dose of 100 mg of minocycline twice daily for 24 months.
889572|NCT01120834|B1|Baseline|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5~Dose level 2: azacitidine 75 mg/m2 on days 1-5~Dose level 3: azacitidine 55 mg/m2 on days 1-5~Dose level 4: azacitidine 75 mg/m2 on days 1-5~Each cycle = 28 days. Subjects may receive up to 6 cycles.~vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.~Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.~Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.~Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.~Each cycle = 28 days. Subjects receive up to 6 cycles."
889573|NCT01120834|P1|Participant Flow|All Subjects|"azacytidine: • Dose level 1: azacitidine 55 mg/m2 on days 1-5~Dose level 2: azacitidine 75 mg/m2 on days 1-5~Dose level 3: azacitidine 55 mg/m2 on days 1-5~Dose level 4: azacitidine 75 mg/m2 on days 1-5~Each cycle = 28 days. Subjects may receive up to 6 cycles.~vorinostat: • Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.~Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.~Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.~Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.~Each cycle = 28 days. Subjects receive up to 6 cycles."
889574|NCT01120834|O1|Outcome|All Subjects|
889575|NCT01120834|E1|Reported Event|All Subjects|all subjects
889576|NCT01120808|B1|Baseline|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
889577|NCT01120808|P1|Participant Flow|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
889578|NCT01120808|O1|Outcome|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
889579|NCT01120808|E1|Reported Event|All Participants|Participants were registered competitors in RacingThePlanet 6 stage 7 day 155mile (250km) ultramarathon.
889580|NCT01120782|B1|Baseline|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
889581|NCT01120782|P1|Participant Flow|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
889582|NCT01120782|O1|Outcome|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
889583|NCT01120782|E1|Reported Event|All Subjects|All subjects wore both the test and control lenses: etafilcon A toric contact lens with a new wetting agent and the marketed etafilcon A toric contact lens. Each lens was worn for a maximum of 15 minutes bilaterally.
889584|NCT01120717|B3|Baseline|Total|Total of all reporting groups
889585|NCT01120717|B2|Baseline|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889586|NCT01120717|B1|Baseline|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889587|NCT01120717|P2|Participant Flow|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889588|NCT01120717|P1|Participant Flow|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889589|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889590|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889591|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889592|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889593|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889594|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889595|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889596|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889597|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889598|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889599|NCT01120717|O2|Outcome|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889600|NCT01120717|O1|Outcome|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889601|NCT01120717|E2|Reported Event|Placebo|Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI
889602|NCT01120717|E1|Reported Event|QVA149|110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
889603|NCT01120704|B33|Baseline|Total|Total of all reporting groups
889604|NCT01120704|B32|Baseline|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889605|NCT01120704|B31|Baseline|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889606|NCT01120704|B30|Baseline|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889607|NCT01120704|B29|Baseline|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889608|NCT01120704|B28|Baseline|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889609|NCT01120704|B27|Baseline|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889610|NCT01120704|B26|Baseline|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889611|NCT01120704|B25|Baseline|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889612|NCT01120704|B24|Baseline|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889613|NCT01120704|B23|Baseline|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889614|NCT01120704|B22|Baseline|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889615|NCT01120704|B21|Baseline|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889616|NCT01120704|B20|Baseline|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889617|NCT01120704|B19|Baseline|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889618|NCT01120704|B18|Baseline|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889619|NCT01120704|B17|Baseline|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889620|NCT01120704|B16|Baseline|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889621|NCT01120704|B15|Baseline|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889622|NCT01120704|B14|Baseline|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889623|NCT01120704|B13|Baseline|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889624|NCT01120704|B12|Baseline|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889625|NCT01120704|B11|Baseline|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889626|NCT01120704|B10|Baseline|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889627|NCT01120704|B9|Baseline|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889628|NCT01120704|B8|Baseline|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889629|NCT01120704|B7|Baseline|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889630|NCT01120704|B6|Baseline|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889631|NCT01120704|B5|Baseline|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889632|NCT01120704|B4|Baseline|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889633|NCT01120704|B3|Baseline|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889634|NCT01120704|B2|Baseline|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889635|NCT01120704|B1|Baseline|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889636|NCT01120704|P32|Participant Flow|32, 8Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889637|NCT01120704|P31|Participant Flow|31, 8Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889638|NCT01120704|P30|Participant Flow|30, 8Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889639|NCT01120704|P29|Participant Flow|29, 8Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889640|NCT01120704|P28|Participant Flow|28, 8Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889641|NCT01120704|P27|Participant Flow|27, 8Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889642|NCT01120704|P26|Participant Flow|26, 8Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889643|NCT01120704|P25|Participant Flow|25, 8Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889644|NCT01120704|P24|Participant Flow|24, 8Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889645|NCT01120704|P23|Participant Flow|23, 8Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889646|NCT01120704|P22|Participant Flow|22, 8Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889647|NCT01120704|P21|Participant Flow|21, 8Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889648|NCT01120704|P20|Participant Flow|20, 8Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889649|NCT01120704|P19|Participant Flow|19, 8Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889650|NCT01120704|P18|Participant Flow|18, 8Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889651|NCT01120704|P17|Participant Flow|17, 8Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~8Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889652|NCT01120704|P16|Participant Flow|16, 26Wks, No Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889653|NCT01120704|P15|Participant Flow|15, 26Wks, No Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889654|NCT01120704|P14|Participant Flow|14, 26Wks, No Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889655|NCT01120704|P13|Participant Flow|13, 26Wks, No Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889656|NCT01120704|P12|Participant Flow|12, 26Wks, No Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889657|NCT01120704|P11|Participant Flow|11, 26Wks, No Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889658|NCT01120704|P10|Participant Flow|10, 26Wks, No Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889659|NCT01120704|P9|Participant Flow|9, 26Wks, No Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, No Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889660|NCT01120704|P8|Participant Flow|8, 26Wks, Counseling, No CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889661|NCT01120704|P7|Participant Flow|7, 26Wks, Counseling, No CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889780|NCT01120379|P1|Participant Flow|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889662|NCT01120704|P6|Participant Flow|6, 26Wks, Counseling, No CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889663|NCT01120704|P5|Participant Flow|5, 26Wks, Counseling, No CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, No Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889664|NCT01120704|P4|Participant Flow|4, 26Wks, Counseling, CAM, No AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889665|NCT01120704|P3|Participant Flow|3, 26Wks, Counseling, CAM, No AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, No Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889666|NCT01120704|P2|Participant Flow|2, 26Wks, Counseling, CAM, AutoCalls, No Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device but No Feedback"
889667|NCT01120704|P1|Participant Flow|1, 26Wks, Counseling, CAM, AutoCalls, Feedback|"This arm of the project will address the following question:~How effective is the following intervention?:~26Wks Medication duration during quit attempt, Maintenance Counseling, Cognitive Adherence Intervention, Automated Medication Adherence Calls, Electronic Medication Monitoring Device + Feedback"
889668|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
889669|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
889670|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
889671|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
889672|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
889781|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889673|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
889674|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
889675|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
889676|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
889677|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
889678|NCT01120704|O10|Outcome|Automated Adherence Prompting Phone Calls|Participants randomized to this condition received Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received No Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
889679|NCT01120704|O9|Outcome|No Automated Adherence Prompting Phone Calls|Participants randomized to this condition received No Automated Adherence Prompting Phone Calls; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback. The No Automated Adherence Prompting Phone Calls group consists of 272 participants (approximately half the total sample of 544) who will be compared with a group that received Automated Adherence Prompting Phone Calls (N=272; approximately half the total sample) in a main effect statistical comparison (No Automated Adherence Prompting Phone Calls vs. Automated Adherence Prompting Phone Calls).
889680|NCT01120704|O8|Outcome|Electronic Medication Monitoring Device Plus Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Plus Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Plus Feedback group consists of 270 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Without Feedback (N=274; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
889681|NCT01120704|O7|Outcome|Electronic Medication Monitoring Device Without Feedback|Participants randomized to this condition received an Electronic Medication Monitoring Device Without Feedback; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling or Cognitive Medication Adherence Counseling; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Electronic Medication Monitoring Device Without Feedback group consists of 274 participants (approximately half the total sample of 544) who will be compared with a group that received an Electronic Medication Monitoring Device Plus Feedback (N=270; approximately half the total sample) in a main effect statistical comparison (Electronic Medication Monitoring Device Without Feedback vs. Electronic Medication Monitoring Device Plus Feedback).
889682|NCT01120704|O6|Outcome|Cognitive Medication Adherence Counseling|Participants randomized to this condition received Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Cognitive Medication Adherence Counseling group consists of 271 participants (approximately half the total sample of 544) who will be compared with a group that received No Cognitive Medication Adherence Counseling (N=273; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
889683|NCT01120704|O5|Outcome|No Cognitive Medication Adherence Counseling|Participants randomized to this condition received No Cognitive Medication Adherence Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Maintenance Counseling or Maintenance Counseling; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Cognitive Medication Adherence Counseling group consists of 273 participants (approximately half the total sample of 544) who will be compared with a group that received Cognitive Medication Adherence Counseling (N=271; approximately half the total sample) in a main effect statistical comparison (No Cognitive Medication Adherence Counseling vs. Cognitive Medication Adherence Counseling).
889684|NCT01120704|O4|Outcome|Maintenance Counseling|Participants randomized to this condition received Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The Maintenance Counseling group consists of 263 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=281; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
889685|NCT01120704|O3|Outcome|No Maintenance Counseling|Participants randomized to this condition received No Maintenance Counseling; participants in this group received all combinations of the other four study treatments: 8 Weeks of Nicotine Patch and Nicotine Gum or 26 Weeks of Nicotine Patch and Nicotine Gum; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The No Maintenance Counseling group consists of 281 participants (approximately half the total sample of 544) who will be compared with a group that received Maintenance Counseling (N=263; approximately half the total sample) in a main effect statistical comparison (No Maintenance Counseling vs. Maintenance Counseling).
889686|NCT01120704|O2|Outcome|26 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 26 Weeks of Nicotine Patch and Nicotine Gum group consists of 275 participants (approximately half the total sample of 544) who will be compared with a group that received 8 Weeks of Nicotine Patch and Nicotine Gum (N=269; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
889687|NCT01120704|O1|Outcome|8 Weeks of Nicotine Patch and Nicotine Gum|Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum; participants in this group received all combinations of the other four study treatments: No Maintenance Counseling or Maintenance Counseling; No Cognitive Medication Adherence Counseling (C-MAC) or C-MAC; Electronic Medication Monitoring Device Without Feedback or Electronic Medication Monitoring Device Plus Feedback; No Automated Adherence Prompting Phone Calls or Automated Adherence Prompting Phone Calls. The 8 Weeks of Nicotine Patch and Nicotine Gum group consists of 269 participants (approximately half the total sample of 544) who will be compared with a group that received 26 Weeks of Nicotine Patch and Nicotine Gum (N=275; approximately half the total sample) in a main effect statistical comparison (8 Weeks of Nicotine Patch and Nicotine Gum vs. 26 Weeks of Nicotine Patch and Nicotine Gum).
889688|NCT01120704|E2|Reported Event|8 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 8 Weeks of Nicotine Patch and Nicotine Gum.~IF participant smoked >10 cigs/day AND is randomized to a 8 week condition: they were asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants were also asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.~IF participant smoked 5-10 cigs/day AND is randomized to the 8 week medication condition: they were asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants were also asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment."
889689|NCT01120704|E1|Reported Event|26 Weeks of Nicotine Patch and Nicotine Gum|"Participants randomized to this condition received 26 Weeks of Nicotine Patch and Nicotine Gum.~IF the participant smoked >10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants were also asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.~IF the participant smoked 5-10 cigs/day AND is randomized to a 26 week medication condition: they were asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants were also asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication"
889690|NCT01120691|B4|Baseline|Total|Total of all reporting groups
889691|NCT01120691|B3|Baseline|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889692|NCT01120691|B2|Baseline|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
889693|NCT01120691|B1|Baseline|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
889694|NCT01120691|P3|Participant Flow|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889695|NCT01120691|P2|Participant Flow|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
889696|NCT01120691|P1|Participant Flow|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
889697|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889698|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889699|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889700|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889701|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889702|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889703|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889704|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889705|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889706|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889707|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889708|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889709|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
890152|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
889710|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889711|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889712|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks.Salbutamol/albuterol was available for rescue medication use throughout the study.
889713|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889714|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889715|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889716|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889717|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889718|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889719|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889720|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889721|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889722|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889723|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889724|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889725|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889726|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889727|NCT01120691|O3|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889728|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889729|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI)for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889730|NCT01120691|O2|Outcome|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889731|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889732|NCT01120691|O2|Outcome|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889733|NCT01120691|O1|Outcome|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889734|NCT01120691|E3|Reported Event|Open-label Tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device. for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889735|NCT01120691|E2|Reported Event|NVA237|NVA237 : NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889736|NCT01120691|E1|Reported Event|QVA149|QVA149 : QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
889737|NCT01120626|B3|Baseline|Total|Total of all reporting groups
889738|NCT01120626|B2|Baseline|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
889739|NCT01120626|B1|Baseline|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
889740|NCT01120626|P2|Participant Flow|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
889741|NCT01120626|P1|Participant Flow|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
889742|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
889743|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
889744|NCT01120626|O2|Outcome|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
889745|NCT01120626|O1|Outcome|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
889746|NCT01120626|E2|Reported Event|Sugar Pill|"sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)~sugar pill: sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)"
889747|NCT01120626|E1|Reported Event|Donepezil|"donepezil (2.5 mg to 10.0 mg per day for 12 weeks)~donepezil: donepezil (2.5 mg to 10.0 mg per day for 12 weeks)"
889748|NCT01120405|B3|Baseline|Total|Total of all reporting groups
889749|NCT01120405|B2|Baseline|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
889750|NCT01120405|B1|Baseline|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
889751|NCT01120405|P2|Participant Flow|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889752|NCT01120405|P1|Participant Flow|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889753|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889754|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889755|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889756|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889757|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group B)
889758|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimal Alveolar Concentration in 30% oxygen (Group A)
889759|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889760|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889761|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889762|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889763|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889764|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889765|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889766|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889767|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889768|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889769|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889770|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889771|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889772|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889773|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889774|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889775|NCT01120405|O2|Outcome|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889776|NCT01120405|O1|Outcome|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889777|NCT01120405|E2|Reported Event|Sevoflurane|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group B)
889778|NCT01120405|E1|Reported Event|Xenon|0.8-1.1 Minimum Alveolar Concentration in 30 % oxygen (Group A)
889779|NCT01120379|B1|Baseline|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889782|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889783|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889784|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889785|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889786|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889787|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889788|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889789|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889790|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889791|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889792|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889793|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889794|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889795|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889796|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889797|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889798|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889799|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889800|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889801|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889802|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889803|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889804|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889805|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889806|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889807|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889808|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889809|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889810|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889811|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889812|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889813|NCT01120379|O1|Outcome|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889814|NCT01120379|E1|Reported Event|XV-LTF Cohort|XIENCE V® EECSS : Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
889855|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889815|NCT01120275|B1|Baseline|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
889816|NCT01120275|P1|Participant Flow|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
889817|NCT01120275|O1|Outcome|RO4929097|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
889818|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
889819|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
889820|NCT01120275|O1|Outcome|Treatment (Gamma-secretase Inhibitor RO4929097)|"Patients receive gamma-secretase/Notch signalling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~gamma-secretase/Notch signalling pathway inhibitor RO4929097: Given PO~laboratory biomarker analysis: Correlative studies"
889821|NCT01120275|E1|Reported Event|RO4929097|Patients receive gamma-secretase/Notch signaling pathway inhibitor RO4929097 PO on days 1-3, 8-10, and 15-17. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
889822|NCT01120236|B3|Baseline|Total|Total of all reporting groups
889823|NCT01120236|B2|Baseline|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889824|NCT01120236|B1|Baseline|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889825|NCT01120236|P2|Participant Flow|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889826|NCT01120236|P1|Participant Flow|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889827|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889828|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889829|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
889830|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
889831|NCT01120236|O2|Outcome|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889856|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
890153|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
889832|NCT01120236|O1|Outcome|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO~Cixutumumab: Given IV~Goserelin Acetate: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leuprolide Acetate: Given IM~Pharmacological Study: Correlative studies"
889833|NCT01120236|E2|Reported Event|Arm II (Androgen Deprivation Therapy)|"Patients receive androgen deprivation therapy comprising bicalutamide and either goserelin acetate or leuprolide acetate as in arm I.~Bicalutamide: Given PO Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
889834|NCT01120236|E1|Reported Event|Arm I (Androgen Deprivation and Cixutumumab)|"Patients receive androgen deprivation therapy comprising bicalutamide PO QD on days 1-28 and either goserelin acetate SC or leuprolide acetate IM every 1, 3, 4, 6, or 12 months. Patients also receive cixutumumab IV over 1 hour on days 1 and 15. Treatment repeats every 28 days for 7 courses in the absence of disease progression or unacceptable toxicity.~Bicalutamide: Given PO Cixutumumab: Given IV Goserelin Acetate: Given SC Laboratory Biomarker Analysis: Correlative studies Leuprolide Acetate: Given IM Pharmacological Study: Correlative studies"
889835|NCT01120223|B1|Baseline|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889836|NCT01120223|P1|Participant Flow|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889837|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889838|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889839|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889840|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889841|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889842|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889843|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889844|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889845|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889846|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889847|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889848|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889849|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889850|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889851|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889852|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889853|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889854|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
890067|NCT01120093|E4|Reported Event|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation by Aerolizer® inhaler at 09:00 (± 30 mins) and 21:00 (± 30 mins) for 7 days.
889857|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889858|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889859|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889860|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889861|NCT01120223|O1|Outcome|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889862|NCT01120223|E1|Reported Event|LEO 80185 Gel Once Daily Application|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp.
889863|NCT01120210|B3|Baseline|Total|Total of all reporting groups
889864|NCT01120210|B2|Baseline|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
889865|NCT01120210|B1|Baseline|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
889866|NCT01120210|P2|Participant Flow|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
889867|NCT01120210|P1|Participant Flow|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
889868|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889869|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889870|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889871|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889872|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889873|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889874|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889875|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889876|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889877|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889878|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889879|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889880|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889881|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889882|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889883|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889884|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889885|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889886|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889887|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889888|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889889|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889890|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889891|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889892|NCT01120210|O2|Outcome|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Planned doses were 5, 15 and 30 ng/kg/min.
889893|NCT01120210|O1|Outcome|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours.
889894|NCT01120210|E2|Reported Event|JNJ-39588146|Patients received 3 consecutive escalating intravenous (IV) infusions of JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
889895|NCT01120210|E1|Reported Event|Placebo|Patients received 3 consecutive escalating intravenous (IV) infusions of placebo identical in appearance to JNJ-39588146. Each dose was planned to be infused over 1 hour for a total planned infusion time in the main study of 3 hours. Patients had an option to participate in an 18-hour extended infusion sub-study following the initial 3-hour infusion main study with the highest dose.
889896|NCT01120197|B3|Baseline|Total|Total of all reporting groups
889897|NCT01120197|B2|Baseline|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
889898|NCT01120197|B1|Baseline|Exercise Group|: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
889899|NCT01120197|P2|Participant Flow|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities"
889900|NCT01120197|P1|Participant Flow|Exercise Group|"Exercise Group: Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).~The intervention is in accordance with Rehabilitation treatment guidelines in postmenupausal and senile osteoporosis ( Bonaiuti et al. 2005)."
889901|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
889902|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
890154|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890155|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
889903|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
889904|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
889905|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
889906|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
889907|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
889908|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
889909|NCT01120197|O2|Outcome|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities. [We recommend specifying length of time they are followed]"
889910|NCT01120197|O1|Outcome|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
889911|NCT01120197|E2|Reported Event|Control Group|"Control group with no intervention~Subjects in the control group are asked to maintain their current lifestyle. No restrictions are placed on their exercise activities."
889912|NCT01120197|E1|Reported Event|Exercise Group|Subjects in the intervention group must participate in a training course consisted of 24 sessions over 3 months. The exercises include aerobic, stretching, balance and functional training, i.e. circuit exercises focus been on: the prevention of falls and fractures, improving balance and coordination, improving posture, and informing subjects about risk factors for falls and for osteoporosis and fractures. A 3-hour session of information and supervision will be hold for the intervention group by the same physiotherapist who leads the training sessions. The focus is on body awareness and ergonomic advice in specific, daily-life situations (e.g. lifting/carrying, resting positions).
889913|NCT01120184|B4|Baseline|Total|Total of all reporting groups
889914|NCT01120184|B3|Baseline|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889915|NCT01120184|B2|Baseline|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889916|NCT01120184|B1|Baseline|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889917|NCT01120184|P3|Participant Flow|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889918|NCT01120184|P2|Participant Flow|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890156|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890157|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
889919|NCT01120184|P1|Participant Flow|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889920|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889921|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889922|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889923|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889924|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889925|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889926|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889927|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889928|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889929|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889930|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889931|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890068|NCT01120093|E3|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
890158|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
889932|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889933|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889934|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889935|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889936|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889937|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889938|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889939|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889940|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889941|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889942|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889943|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889944|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889945|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890069|NCT01120093|E2|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
889946|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889947|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889948|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889949|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889950|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889951|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889952|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889953|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889954|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889955|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889956|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889957|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889958|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890070|NCT01120093|E1|Reported Event|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation by Genuair® multidose dry powder inhaler: 1 puff at 09:00 (± 30 mins) and at 21:00 (± 30 mins) for 7 days.
890071|NCT01120067|B3|Baseline|Total|Total of all reporting groups
895537|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
889959|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889960|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889961|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889962|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889963|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889964|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889965|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889966|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889967|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889968|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889969|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889970|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889971|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889972|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890072|NCT01120067|B2|Baseline|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
895538|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
889973|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889974|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889975|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889976|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889977|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889978|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889979|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889980|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889981|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889982|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889983|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889984|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889985|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890073|NCT01120067|B1|Baseline|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
889986|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889987|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889988|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889989|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889990|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889991|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889992|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889993|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889994|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889995|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889996|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889997|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
889998|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
889999|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890074|NCT01120067|P2|Participant Flow|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
895539|NCT01104584|O1|Outcome|CMRM vs UMRM|
890000|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890001|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890002|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890003|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890004|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890005|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890006|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890007|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890008|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890009|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890010|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890011|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890012|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890075|NCT01120067|P1|Participant Flow|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
890013|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890014|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890015|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890016|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890017|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890018|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890019|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890020|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890021|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890022|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890023|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890024|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890025|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890026|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890076|NCT01120067|O2|Outcome|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
895540|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
890027|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890028|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890029|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890030|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890031|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890032|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890033|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890034|NCT01120184|O3|Outcome|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890035|NCT01120184|O2|Outcome|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890036|NCT01120184|O1|Outcome|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890037|NCT01120184|E3|Reported Event|Trastuzumab Emtansine + Pertuzumab|Participants received trastuzumab emtansine plus pertuzumab. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the pertuzumab IV infusion, on Day 1 of each 3-week cycle. Pertuzumab was given as 840 mg IV on Day 1 of Cycle 1, then 420 mg IV on Day 1 of each subsequent 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890038|NCT01120184|E2|Reported Event|Trastuzumab Emtansine + Placebo|Participants received trastuzumab emtansine plus pertuzumab-placebo. Trastuzumab emtansine was administered as 3.6 mg/kg via IV infusion, following completion of the placebo IV infusion, on Day 1 of each 3-week cycle. Treatment continued until disease progression, unacceptable toxicity, or study termination.
890039|NCT01120184|E1|Reported Event|Trastuzumab + Taxane|Participants received trastuzumab plus either docetaxel or paclitaxel. The regimen was chosen at the investigator's discretion. Option 1: trastuzumab 8 mg/kg via IV infusion on Day 1 of Cycle 1, then 6 mg/kg IV on Day 1 of each subsequent 3-week cycle; plus a minimum of 6 cycles with docetaxel 75 or 100 mg/m^2 IV on Day 1 of each 3-week cycle. Option 2: trastuzumab 4 mg/kg IV on Day 1 of Cycle 1, then 2 mg/kg IV weekly beginning on Day 8 of Cycle 1; plus a minimum of 18 weeks with paclitaxel 80 mg/m^2 IV weekly. Treatment continued until disease progression, unacceptable toxicity, or study termination. If trastuzumab or docetaxel were discontinued for toxicity, the other agent could be continued as monotherapy.
890040|NCT01120093|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
890143|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890144|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890041|NCT01120093|P5|Participant Flow|Placebo;Aclidinium100;Formoterol;Aclidinium200;Aclidinium400|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
890042|NCT01120093|P4|Participant Flow|Formoterol;Placebo;Aclidinium400;Aclidinium100;Aclidinium200|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
890043|NCT01120093|P3|Participant Flow|Aclidinium400;Formoterol;Aclidinium200;Placebo;Aclidinium100|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
890044|NCT01120093|P2|Participant Flow|Aclidinium200;Aclidinium400;Aclidinium100;Formoterol;Placebo|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days."
890045|NCT01120093|P1|Participant Flow|Aclidinium100;Aclidinium200;Placebo;Aclidinium400;Formoterol|"The treatment period consisted of 5 periods of 7 treatment days each separated by a washout period of 7 (±2) days.~In period 1, patients received aclidinium bromide 100 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 2, patients received aclidinium bromide 200 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 3, patients received placebo from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 4, patients received aclidinium bromide 400 μg from the Eklira Genuair® inhaler and placebo from the Aerolizer® inhaler in the morning and evening for 7 days.~In period 5, patients received placebo from the Eklira Genuair® inhaler and formoterol from the Aerolizer® inhaler in the morning and evening for 7 days."
890046|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
890047|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
890048|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
890049|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
890050|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
890051|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
890052|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
890053|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
890054|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
890055|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
890056|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
890057|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
890058|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
890059|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
890060|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
890061|NCT01120093|O5|Outcome|Placebo|Placebo via inhalation
890062|NCT01120093|O4|Outcome|Formoterol 12 μg Bid|Formoterol 12 μg twice-daily via inhalation
890063|NCT01120093|O3|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
890064|NCT01120093|O2|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
890065|NCT01120093|O1|Outcome|Aclidinium Bromide 100 μg Bid|Aclidinium bromide 100 μg twice-daily via inhalation
890066|NCT01120093|E5|Reported Event|Placebo|Inhaled placebo dose for 7 days.
890145|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890077|NCT01120067|O1|Outcome|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
890078|NCT01120067|E2|Reported Event|Treatment as Usual|"Treatment as Usual. Participants are eligible for all treatment services as needed except for treatment of pain or PTSD~Treatment as Usual: Treatment as Usual."
890079|NCT01120067|E1|Reported Event|Intensive Treatment|"Intensive 3 week treatment for pain and PTSD. This includes elements of Cognitive Processing Therapy and CBT for Chronic Pain~Intensive Treatment: Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration."
890080|NCT01119950|B1|Baseline|All Participants|All participants in the safety set
890081|NCT01119950|P1|Participant Flow|Overall Study|"For the overall study, 388 participants were randomized and 1 non-randomized participant received drug in error and was discontinued. This participant was excluded from randomized number of patients but included in number of treated participants and in the safety set.~Out of the 388 participants randomized, 341 completed study treatment and 47 discontinued, including 3 misrandomized participants who did not receive any study medication."
890082|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890083|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890084|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890085|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890086|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890087|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890088|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890089|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890090|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890091|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890092|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890093|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890094|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890095|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890096|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890097|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890098|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890099|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890100|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890101|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890102|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890103|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890104|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890105|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890106|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890107|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890108|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890109|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890110|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890111|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890112|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890113|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890114|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890115|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890116|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890117|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890118|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890119|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890120|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890121|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890122|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890123|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890124|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890125|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890126|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890127|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890128|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890129|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890130|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890131|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890132|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890133|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890134|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890135|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890136|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890137|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890138|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890139|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890140|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890141|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890142|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890165|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890166|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890167|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890168|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890169|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890170|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890171|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890172|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890173|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890174|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890175|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890176|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890177|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890178|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890179|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890180|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890181|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890182|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890183|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890184|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890185|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890186|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890187|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890188|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890189|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890190|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890191|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890192|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890193|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890194|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890195|NCT01119950|O7|Outcome|NVA237 50 ug b.i.d.|NVA237 50 ug twice daily
890196|NCT01119950|O6|Outcome|NVA237 100 ug q.d.|NVA237 100 ug once daily
890197|NCT01119950|O5|Outcome|NVA237 25 ug b.i.d.|NVA237 25 ug twice daily
890198|NCT01119950|O4|Outcome|NVA237 50 ug q.d.|NVA237 50 ug once daily
890199|NCT01119950|O3|Outcome|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug twice daily
890200|NCT01119950|O2|Outcome|NVA237 25 ug q.d.|NVA237 12.5 ug once daily
890201|NCT01119950|O1|Outcome|NVA237 12.5 ug q.d.|NVA237 25 ug once daily
890202|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890203|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890204|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890205|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890206|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890207|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890208|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890209|NCT01119950|O8|Outcome|Placebo|Placebo to NVA237 once daily
890210|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890211|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890212|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890213|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890214|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890215|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890216|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890217|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890218|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890219|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890220|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890221|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890222|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890223|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890224|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890225|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890226|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890227|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890228|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890229|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890230|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890231|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890232|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890233|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890234|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
895541|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
890235|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890236|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890237|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890238|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890239|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890240|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890241|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890242|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890243|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890244|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890245|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890246|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890247|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890248|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890249|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890250|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890251|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890252|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890253|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890254|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890255|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890256|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890257|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890258|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890259|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890260|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890261|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890262|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890263|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890264|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890265|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890266|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890267|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890268|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890269|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890270|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890271|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890272|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890273|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890274|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890275|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890276|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890277|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890278|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890279|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890280|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890281|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890282|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890283|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890284|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890285|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890286|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890287|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890288|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890289|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890290|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890291|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890292|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890293|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890294|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890295|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890296|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890297|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890298|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890299|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890300|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890301|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890302|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890303|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890304|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890305|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890306|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890307|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890367|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890308|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
890309|NCT01119950|O7|Outcome|NVA237 50.0 µg b.i.d.|NVA237 50.0 µg twice daily
890310|NCT01119950|O6|Outcome|NVA237 100.0 µg q.d.|NVA237 100.0 µg once daily
890311|NCT01119950|O5|Outcome|NVA237 25.0 µg b.i.d.|NVA237 25.0 µg twice daily
890312|NCT01119950|O4|Outcome|NVA237 50.0 µg q.d.|NVA237 50.0 µg once daily
890313|NCT01119950|O3|Outcome|NVA237 12.5 µg b.i.d.|NVA237 12.5 µg twice daily
890314|NCT01119950|O2|Outcome|NVA237 25.0 µg q.d.|NVA237 25.0 µg once daily
890315|NCT01119950|O1|Outcome|NVA237 12.5 µg q.d.|NVA237 12.5 µg once daily
890316|NCT01119950|O1|Outcome|Overall Study|A statistical modeling process was used to achieve the key objective. A set of 4 candidate models based on the Emax dose-response shape was derived plus their sigmoidal Emax counterparts (a total of 8 models) that describe the evolution of dose response over time. A model-averaging process was then employed to obtain response predictions as the weighted average of individual model predictions and confidence limits derived using a simulation-based procedure.
890317|NCT01119950|E8|Reported Event|Placebo|Placebo
890318|NCT01119950|E7|Reported Event|NVA237 50 ug b.i.d.|NVA237 50 ug b.i.d.
890319|NCT01119950|E6|Reported Event|NVA237 100 ug q.d.|NVA237 100 ug q.d.
890320|NCT01119950|E5|Reported Event|NVA237 25 ug b.i.d.|NVA237 25 ug b.i.d.
890321|NCT01119950|E4|Reported Event|NVA237 50 ug q.d.|NVA237 50 ug q.d.
890322|NCT01119950|E3|Reported Event|NVA237 12.5 ug b.i.d.|NVA237 12.5 ug b.i.d.
890323|NCT01119950|E2|Reported Event|NVA237 25 ug q.d.|NVA237 25 ug q.d.
890324|NCT01119950|E1|Reported Event|NVA237 12.5 ug q.d.|NVA237 12.5 ug q.d.
890325|NCT01119937|B3|Baseline|Total|Total of all reporting groups
890326|NCT01119937|B2|Baseline|Tiotropium|18µg once daily
890327|NCT01119937|B1|Baseline|NVA237|50µg once daily
890328|NCT01119937|P2|Participant Flow|Tiotropium|18µg once daily
890329|NCT01119937|P1|Participant Flow|NVA237|50µg once daily
890330|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890331|NCT01119937|O1|Outcome|NVA237|50µg once daily
890332|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890333|NCT01119937|O1|Outcome|NVA237|50µg once daily
890334|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890335|NCT01119937|O1|Outcome|NVA237|50µg once daily
890336|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890337|NCT01119937|O1|Outcome|NVA237|50µg once daily
890338|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890339|NCT01119937|O1|Outcome|NVA237|50µg once daily
890340|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890341|NCT01119937|O1|Outcome|NVA237|50µg once daily
890342|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890343|NCT01119937|O1|Outcome|NVA237|50µg once daily
890344|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890345|NCT01119937|O1|Outcome|NVA237|50µg once daily
890346|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890347|NCT01119937|O1|Outcome|NVA237|50µg once daily
890348|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890349|NCT01119937|O1|Outcome|NVA237|50µg once daily
890350|NCT01119937|O2|Outcome|Tiotropium|18µg once daily
890351|NCT01119937|O1|Outcome|NVA237|50µg once daily
890352|NCT01119937|E2|Reported Event|Tiotropium|18µg once daily
890353|NCT01119937|E1|Reported Event|NVA237|50µg once daily
890354|NCT01119859|B3|Baseline|Total|Total of all reporting groups
890355|NCT01119859|B2|Baseline|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890356|NCT01119859|B1|Baseline|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890357|NCT01119859|P2|Participant Flow|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890358|NCT01119859|P1|Participant Flow|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890359|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890360|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890361|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890362|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890363|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890364|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890365|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890366|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890590|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890368|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890369|NCT01119859|O2|Outcome|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890498|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890370|NCT01119859|O1|Outcome|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890371|NCT01119859|E2|Reported Event|Adalimumab 40 mg|Patients received 12 injections of adalimumab 40 mg subcutaneously every 2 weeks and 6 infusions of placebo to tocilizumab intravenously every 4 weeks.
890372|NCT01119859|E1|Reported Event|Tocilizumab 8 mg/kg|Patients received 6 infusions of tocilizumab 8 mg/kg intravenously every 4 weeks and 12 injections of placebo to adalimumab subcutaneously every 2 weeks.
890373|NCT01119794|B1|Baseline|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
890374|NCT01119794|P1|Participant Flow|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
890375|NCT01119794|O1|Outcome|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
890376|NCT01119794|E1|Reported Event|Ofatumumab IV,|"Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22,~Ofatumumab and Bortezomib: Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22- in the induction phase Ofatumumab 1000 mg IV on day 1- will receive in the maintenance phase Patients will remain until progression"
890377|NCT01119768|B3|Baseline|Total|Total of all reporting groups
890378|NCT01119768|B2|Baseline|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890379|NCT01119768|B1|Baseline|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890380|NCT01119768|P2|Participant Flow|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890381|NCT01119768|P1|Participant Flow|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890382|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890383|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890384|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890385|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890386|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890387|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890388|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890389|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890390|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890391|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890392|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890393|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890394|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890395|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890396|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890397|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890398|NCT01119768|O2|Outcome|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890399|NCT01119768|O1|Outcome|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890400|NCT01119768|E2|Reported Event|Esomeprazole 2 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 2 weeks
890401|NCT01119768|E1|Reported Event|Esomeprazole 8 Weeks Treatment|20 mg q.d. (quaque die) once a day dosing for 8 weeks
890402|NCT01119755|B1|Baseline|Group 1|
890403|NCT01119755|P1|Participant Flow|Group 1|
890404|NCT01119755|O1|Outcome|Group 1|
890405|NCT01119755|O1|Outcome|Group 1|
890406|NCT01119755|O1|Outcome|Group 1|
890407|NCT01119755|O1|Outcome|Group 1|
890408|NCT01119755|O1|Outcome|Group 1|
890409|NCT01119755|O1|Outcome|Group 1|
890410|NCT01119755|O1|Outcome|Group 1|
890411|NCT01119755|O1|Outcome|Group 1|
890412|NCT01119755|E1|Reported Event|Group 1|
890413|NCT01119716|B1|Baseline|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890414|NCT01119716|P1|Participant Flow|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890415|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890416|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890417|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890591|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
890418|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890419|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
917343|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
890420|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom an electrical or pharmacological cardioversion was perfomed
890421|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890422|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890423|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890424|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890425|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890426|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890427|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890428|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890429|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890430|NCT01119716|O3|Outcome|Total|All participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890431|NCT01119716|O2|Outcome|Female|Female participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890432|NCT01119716|O1|Outcome|Male|Male participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890433|NCT01119716|E1|Reported Event|All Enrolled Participants|Participants with documented atrial fibrillation in the hospital setting for whom a cardioversion is one of the planned therapeutic options
890434|NCT01119703|B3|Baseline|Total|Total of all reporting groups
890435|NCT01119703|B2|Baseline|Elderly Participants|Aged 65 years and older
890436|NCT01119703|B1|Baseline|Younger Participants|Aged 25 to 40 years old
890437|NCT01119703|P2|Participant Flow|Elderly Participants|Participants 65 years old and older.
890438|NCT01119703|P1|Participant Flow|Younger Participants|Participants 25 to 40 years of age.
890439|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890440|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890441|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890442|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890443|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890444|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890445|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890446|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older
890447|NCT01119703|O1|Outcome|Elderly Participants|Healthy participants 65 years of age and older.
890448|NCT01119703|E1|Reported Event|All Participants|Participants who received at least one dose of each vaccine
890449|NCT01119625|B3|Baseline|Total|Total of all reporting groups
890450|NCT01119625|B2|Baseline|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890451|NCT01119625|B1|Baseline|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890452|NCT01119625|P2|Participant Flow|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890453|NCT01119625|P1|Participant Flow|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890495|NCT01119443|P2|Participant Flow|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
890496|NCT01119443|P1|Participant Flow|Treatment Sequence A|1.5 mg x 1 tablet once daily (q.d.) fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
890497|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890454|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890455|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890456|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890457|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890458|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890459|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890460|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890461|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890462|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890463|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890464|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890465|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890466|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890467|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890468|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890469|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890470|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890471|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890472|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890473|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890474|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890475|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890476|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890477|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890478|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890479|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890480|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890481|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890482|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890483|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890484|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890485|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890486|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890487|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890488|NCT01119625|O2|Outcome|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890489|NCT01119625|O1|Outcome|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890490|NCT01119625|E2|Reported Event|Synflorix™ Commercial-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of commercial lot of Synflorix™ co-administered with Rotarix™ and Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890491|NCT01119625|E1|Reported Event|Synflorix™ Clinical-Commercial + Infanrix™-IPV/Hib Group|children primed with 3 doses of clinical lot of Synflorix™ + Rotarix™ co-administered with Infanrix™-hexa in the primary phase of the study (NCT00808444) and boosted with commercial lot of Synflorix™ co-administered with Infanrix™-IPV/Hib. The Synflorix™ vaccine (clinical and commercial lots) was administered intramuscularly in the right deltoid or anterolateral thigh and the Infanrix™-IPV/Hib vaccine was administered intramuscularly in the left deltoid or anterolateral thigh.
890492|NCT01119443|B3|Baseline|Total|Total of all reporting groups
890493|NCT01119443|B2|Baseline|Treatment Sequence B|0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fasted -> 1.5 mg x 1 tablet q.d. fasted
890494|NCT01119443|B1|Baseline|Treatment Sequence A|1.5 mg x 1 tablet q.d. fed -> 0.375 mg x 4 tablets q.d. fed -> 1.5 mg x 1 tablet q.d. fasted -> 0.375 mg x 4 tablets q.d. fasted
890588|NCT01119222|O1|Outcome|Gabpentin|Gabapentin 1200 mg
890499|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890500|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890501|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890502|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890503|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890504|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890505|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890506|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890507|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890508|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890509|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890510|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890511|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fasted|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fasted conditions
890512|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fasted|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fasted conditions
890513|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890514|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890515|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890516|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890517|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890518|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890519|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890520|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890521|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890522|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890523|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890524|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890525|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890526|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890527|NCT01119443|O2|Outcome|Pramipexole ER 0.375 mg x 4 Tablets q.d. in Fed|Pramipexole ER 0.375 mg x 4 tablets once a day (q.d.) under fed conditions
890528|NCT01119443|O1|Outcome|Pramipexole ER 1.5 mg x 1 Tablet q.d. in Fed|Pramipexole ER 1.5 mg x 1 tablet once a day (q.d.) under fed conditions
890529|NCT01119443|E3|Reported Event|1.5 mg q.d. Fast|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fast condition (10 days in crossover)
890530|NCT01119443|E2|Reported Event|1.5 mg q.d. Fed|1.5 mg x 1 tablet q.d. or 0.375 mg x 4 tablets q.d. in fed condition (10days in crossover)
890531|NCT01119443|E1|Reported Event|Up-titration|Up-titration to 0.75mg (10 days)
890532|NCT01119287|B7|Baseline|Total|Total of all reporting groups
890533|NCT01119287|B6|Baseline|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890534|NCT01119287|B5|Baseline|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890535|NCT01119287|B4|Baseline|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890536|NCT01119287|B3|Baseline|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890537|NCT01119287|B2|Baseline|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890538|NCT01119287|B1|Baseline|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890589|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890539|NCT01119287|P6|Participant Flow|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890540|NCT01119287|P5|Participant Flow|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890596|NCT01119222|E1|Reported Event|Gabapentin|Gabapentin single oral 1200 mg dose
890541|NCT01119287|P4|Participant Flow|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890542|NCT01119287|P3|Participant Flow|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890543|NCT01119287|P2|Participant Flow|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890544|NCT01119287|P1|Participant Flow|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890545|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890546|NCT01119287|O3|Outcome|Patanol/Cat Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890547|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890548|NCT01119287|O1|Outcome|Patanol/Ragweed Allergic|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890549|NCT01119287|O4|Outcome|Tears Naturale II/Cat Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890550|NCT01119287|O3|Outcome|Maxidex/Cat Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890551|NCT01119287|O2|Outcome|Tears Naturale II/Ragweed Allergic|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890552|NCT01119287|O1|Outcome|Maxidex/Ragweed Allergic|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890553|NCT01119287|E3|Reported Event|Tears Naturale II|Inactive ingredients, used as placebo, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890554|NCT01119287|E2|Reported Event|Patanol|Olopatadine hydrochloride 0.1% ophthalmic solution, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890555|NCT01119287|E1|Reported Event|Maxidex|Dexamethasone 0.1% ophthalmic suspension, 2 drops in each eye, 2-5 minutes apart, twice a day, for 9 days [Visit 4 through Visit 6 morning only]
890556|NCT01119222|B1|Baseline|Entire Study Population|Includes all participants who initiated in any treatment sequence
890557|NCT01119222|P4|Participant Flow|Diphenhydramine, Placebo, Gabapentin, Morphine|Diphenhydramine 50 mg tablet first, then placebo (capsules, tablet and intravenous (IV), then gabapentin 1200 mg capsule, then morphine 10 mg IV.
890558|NCT01119222|P3|Participant Flow|Gabapentin, Diphenhydramine, Morphine, Placebo|Gabapentin 1200 mg capsule first, then diphenhydramine 50 mg tablet, then morphine 10 mg intravenous (IV), then placebo (capsules, tablet and IV).
890559|NCT01119222|P2|Participant Flow|Morphine, Gabapentin, Placebo, Diphenhydramine|Morphine 10 mg intravenous (IV) first, then gabapentin 1200 mg capsule, placebo (capsules, tablet and IV), then diphenhydramine 50 mg tablet.
890560|NCT01119222|P1|Participant Flow|Placebo, Morphine, Diphenhydramine, Gabapentin|Placebo (capsules, tablet and intravenous (IV) first, then morphine 10 mg IV, then diphenhydramine 50 mg tablet, then gabapentin 1200 mg capsule.
890561|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890562|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890563|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
890564|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
890565|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890566|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890567|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
890568|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
890569|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890570|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890571|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
890572|NCT01119222|O1|Outcome|Gabapentin|Gabapentin 1200 mg
890573|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890574|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890575|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
890576|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
890577|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890578|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890579|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
890580|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
890581|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890582|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890583|NCT01119222|O2|Outcome|Morphine|Morphine single IV 10 mg dose
890584|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
890585|NCT01119222|O4|Outcome|Placebo|Oral and IV doses to match active treatments
890586|NCT01119222|O3|Outcome|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890587|NCT01119222|O2|Outcome|Morphine|Morphine 10 mg
890592|NCT01119222|O1|Outcome|Gabapentin|Gabapentin single oral 1200 mg dose
890593|NCT01119222|E4|Reported Event|Placebo|Oral and IV doses to match active treatments
890594|NCT01119222|E3|Reported Event|Diphenhydramine|Diphenhydramine single oral 50 mg dose
890595|NCT01119222|E2|Reported Event|Morphine|Morphine single IV 10 mg dose
890598|NCT01119131|B3|Baseline|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890599|NCT01119131|B2|Baseline|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890600|NCT01119131|B1|Baseline|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890601|NCT01119131|P3|Participant Flow|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890602|NCT01119131|P2|Participant Flow|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890603|NCT01119131|P1|Participant Flow|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890604|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890605|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890606|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890607|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890608|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890609|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890610|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890611|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890612|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890613|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890614|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890615|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890616|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890617|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890618|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890619|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890620|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890621|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890622|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890623|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890624|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890625|NCT01119131|O3|Outcome|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890626|NCT01119131|O2|Outcome|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890627|NCT01119131|O1|Outcome|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890628|NCT01119131|E3|Reported Event|Placebo|"Will be on placebo and 1000mg of calcium.~calcium: 1000mg calcium daily~Placebo: A placebo pill with similar appearance to the vitamin D will be given to those in the placebo arm"
890629|NCT01119131|E2|Reported Event|Vitamin D|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890630|NCT01119131|E1|Reported Event|Vitamin D (Open Label)|"Will be on high dose vitamin D (10,000 IU daily) and 1000 mg of calcium~Vitamin D: Vitamin D at 10,000 IU a day~calcium: 1000mg calcium daily"
890631|NCT01119118|B1|Baseline|ZD4054|ZD4054 + multimodal PET/MRI imaging
890632|NCT01119118|P1|Participant Flow|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
890633|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
890634|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
890635|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
890636|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
890637|NCT01119118|O1|Outcome|ZD4054|ZD4054 therapy at the starting dose of 10 mg PO with multimodal PET/MRI imaging
890638|NCT01119118|E1|Reported Event|ZD4054|ZD4054 + multimodal PET/MRI imaging
890639|NCT01119040|B1|Baseline|Peg Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
890640|NCT01119040|P1|Participant Flow|"NOTES PEG Rescue"|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
890641|NCT01119040|O1|Outcome|NOTES PEG Rescue|Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions.
890642|NCT01119040|E1|Reported Event|NOTES PEG Rescue|Peg Rescue with NOTES in lieu of traditional surgical methods for dislodged PEG tubes.
890643|NCT01119001|B1|Baseline|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
890644|NCT01119001|P1|Participant Flow|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
890645|NCT01119001|O3|Outcome|Assistive Technology Enironment|Accuracy typing for three sessions with the BCI acting as a keyboard for a Dynawrite communication system.
890646|NCT01119001|O2|Outcome|Computer Environment|Accuracy typing for three sessions with the BCI acting as a keyboard for a laptop computer.
890647|NCT01119001|O1|Outcome|Brain-computer Interface (BCI) Environment|Accuracy typing for three sessions with the BCI acting as a stand-alone device.
890648|NCT01119001|E1|Reported Event|P300 Brain Computer Interface for People With ALS|P300 Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
890649|NCT01118988|B4|Baseline|Total|Total of all reporting groups
890650|NCT01118988|B3|Baseline|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
890651|NCT01118988|B2|Baseline|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890652|NCT01118988|B1|Baseline|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890653|NCT01118988|P3|Participant Flow|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
890654|NCT01118988|P2|Participant Flow|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890655|NCT01118988|P1|Participant Flow|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890656|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890697|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
890884|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890885|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
890710|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890890|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890657|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890658|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890659|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890660|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890661|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890662|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890663|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890664|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890665|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890666|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890667|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890668|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890669|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890670|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890671|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890672|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890673|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890674|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890698|NCT01118962|E1|Reported Event|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
890675|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890676|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890677|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890678|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890679|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890680|NCT01118988|O2|Outcome|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890681|NCT01118988|O1|Outcome|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890682|NCT01118988|E3|Reported Event|Mentors|"Subjects recruited to the Mentor arm of the study are UCLA Pediatric Pain Program patients between the ages of 14 and 18. These mentors are identified by the Principal Investigator as children who have not necessarily eliminated pain, but have learned how to cope with pain and maintain appropriate functioning in daily life. Mentors undergo an in depth training from doctoral level psychologists who are members of the research team. Mentors present pain coping information developed by the research team, provide support, and encourage mentees to attend pain management therapies. They are also monitored by doctoral level psychologists throughout the duration of the study to ensure safety and appropriate contact with mentees via telephone."
890683|NCT01118988|E2|Reported Event|Control|Subjects randomly assigned to this control group receive treatment as usual (TAU).
890684|NCT01118988|E1|Reported Event|Mentorship|"Subjects randomly assigned to this arm received the specified Mentorship Intervention~Mentorship: Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties."
890685|NCT01118975|B3|Baseline|Total|Total of all reporting groups
890686|NCT01118975|B2|Baseline|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
890687|NCT01118975|B1|Baseline|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
890688|NCT01118975|P2|Participant Flow|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
890689|NCT01118975|P1|Participant Flow|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
890690|NCT01118975|O1|Outcome|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days off
890691|NCT01118975|O1|Outcome|Pilot Phase|The pilot phase consisted of an escalating dose design. Three patients received lapatinib 1,250 mg daily plus 300 mg vorinistat 4 days on then 3 days off. This dose was tolerated so six more patients recieved lapatinib 1,250 mg daily plus 400 mg vorinistat 4 days on 3 days off.
890692|NCT01118975|E2|Reported Event|Phase II - Vorinistat 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and vorinostat 400 mg 4 days on 3 days
890693|NCT01118975|E1|Reported Event|Pilot Phase - Vornistat 200 to 400mg + Lapatinib|lapatinib 1,250 mg continuous daily and escalating doses of vorinistat (200mg run-up, 300mg, and 400mg 4 days on 3 days off)
890694|NCT01118962|B1|Baseline|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
890695|NCT01118962|P1|Participant Flow|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
890696|NCT01118962|O1|Outcome|Lacosamide|"Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949).~Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses."
890886|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
890699|NCT01118949|B1|Baseline|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890700|NCT01118949|P1|Participant Flow|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890701|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890702|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890703|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890704|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890705|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890706|NCT01118949|O1|Outcome|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890707|NCT01118949|E1|Reported Event|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
890708|NCT01118845|B1|Baseline|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890709|NCT01118845|P1|Participant Flow|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890711|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890712|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890713|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890714|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890715|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890716|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890717|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890718|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890719|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890720|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890721|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890722|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890723|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890724|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890725|NCT01118845|O1|Outcome|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890726|NCT01118845|E1|Reported Event|SyB L-0501|SyB L-0501 was administered in combination with rituximab. SyB L-0501 was administered at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule. Rituximab was administered at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
890728|NCT01118780|B2|Baseline|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890729|NCT01118780|B1|Baseline|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890730|NCT01118780|P2|Participant Flow|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890731|NCT01118780|P1|Participant Flow|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890732|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890733|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890734|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890735|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890736|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890737|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890738|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
895542|NCT01104584|O1|Outcome|CMRM vs UMRM|
890763|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890891|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
890892|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
890739|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890740|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890741|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890742|NCT01118780|O3|Outcome|Placebo|Participants, whose final dose during the treatment period was either placebo or duloxetine 30 mg, were administered a placebo capsule orally, once daily for 2 weeks, during the 2-week taper period.
890743|NCT01118780|O2|Outcome|Duloxetine 60 mg Then 30 mg|Participants, whose final dose during the treatment period was 90 mg or 120 mg duloxetine, were administered duloxetine 60 mg (two 30-mg duloxetine capsules) orally, once daily for 1 week followed by a 30-mg duloxetine capsule orally, once daily for 1 week, during the 2-week taper period.
890744|NCT01118780|O1|Outcome|Duloxetine 30 mg Then Placebo|Participants, whose final dose during the treatment period was duloxetine 60 mg, were administered a 30-mg duloxetine capsule orally, once daily for 1 week followed by a placebo capsule orally, once daily for 1 week, during the 2-week taper period.
890745|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890746|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890747|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890748|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890749|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890750|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890751|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
895543|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
890752|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890753|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890754|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890755|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890756|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890757|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890758|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890759|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890760|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890761|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890762|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890764|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890765|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890766|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890767|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890768|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890769|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890770|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890771|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890772|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890773|NCT01118780|O2|Outcome|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890798|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890799|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890800|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890774|NCT01118780|O1|Outcome|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890775|NCT01118780|E2|Reported Event|Placebo|A placebo capsule administered orally, once daily for 10 weeks. At the end of the 10-week treatment period, participants had choice to enter the 2-week taper period (placebo capsule administered orally, once daily for 2 weeks) or begin active treatment (duloxetine or other).
890776|NCT01118780|E1|Reported Event|Duloxetine|"30 to 120 milligrams (mg) administered orally, once daily for 10 weeks. Starting dose, 30-mg capsule, once daily for 2 weeks, with option to increase dose (30-mg increments) at Weeks 2, 4, and 7. If participant's Clinical Global Impression of Improvement (CGI-Improvement) Score was ≥3 (minimal improvement, no change, or worse) at Week 2, 4, or 7, the dose was required to be increased by 30 mg. At end of 10-week treatment period, participants had choice to enter 2-week taper period or begin active treatment (duloxetine or other).~Optional taper period: Dosing was dependent on the participant's final dosage during the treatment period. Participants taking duloxetine 120 or 90 mg once daily received duloxetine 60 mg once daily for 1 week followed by 30 mg once daily for 1 week. Participants taking duloxetine 60 mg once daily received duloxetine 30 mg once daily for 1 week followed by placebo for 1 week. Participants taking duloxetine 30 mg once daily received placebo for 2 weeks."
890777|NCT01118741|B3|Baseline|Total|Total of all reporting groups
890778|NCT01118741|B2|Baseline|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
890779|NCT01118741|B1|Baseline|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
890780|NCT01118741|P2|Participant Flow|Disulfiram High Dose 500mg Dose|After accrual to the low dose was complete,ten subjects were assigned to the high dose (500mg) arm. These subjects took 500mg daily for 28 days per cycle.
890781|NCT01118741|P1|Participant Flow|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose (250mg) arm. These subjects took 250mg daily for 28 days per cycle.
890782|NCT01118741|O2|Outcome|Disulfiram High Dose 500mg Dose|
890783|NCT01118741|O1|Outcome|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
890784|NCT01118741|E2|Reported Event|Disulfiram High Dose 500mg Dose|After 9 subjects were enrolled in the low dose arm, the high dose was opened.
890785|NCT01118741|E1|Reported Event|Disulfiram Low Dose 250mg Dose|First 9 subjects were assigned to the low dose arm
890786|NCT01118663|B3|Baseline|Total|Total of all reporting groups
890787|NCT01118663|B2|Baseline|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890788|NCT01118663|B1|Baseline|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890789|NCT01118663|P2|Participant Flow|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890790|NCT01118663|P1|Participant Flow|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890791|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890792|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890793|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890794|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890795|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890796|NCT01118663|O1|Outcome|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890797|NCT01118663|O2|Outcome|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890881|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890882|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
890883|NCT01118325|O1|Outcome|Arm 1 - AZD6140 45 mg bd|AZD6140 45 mg twice daily
890801|NCT01118663|E2|Reported Event|Acetadote|"Acetadote [Old formulation containing EDTA]~Acetadote: Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours."
890802|NCT01118663|E1|Reported Event|Acetadote Without EDTA|"Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]~Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free]: Acetadote EF [Ethylenediaminetetraacetic Acid (EDTA) - Free] {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours"
890803|NCT01118624|B1|Baseline|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
890804|NCT01118624|P1|Participant Flow|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
890805|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
890806|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
890807|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
890808|NCT01118624|O1|Outcome|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
890809|NCT01118624|E1|Reported Event|Pralatrexate|Study drug 190 mg/m^2 for 2 to 4 weeks.
890810|NCT01118455|B3|Baseline|Total|Total of all reporting groups
890811|NCT01118455|B2|Baseline|Anti-Epileptic Drug (AED) - ITT Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
890812|NCT01118455|B1|Baseline|Vagus Nerve Stimulation (VNS) Therapy - ITT Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~The intent-to-treat (ITT) population, defined as all subjects in VNS Therapy arm implanted with the VNS Therapy System (and the device had been turned on), and the Non-VNS arm, defined as all subjects who took at least 1 dose of study AED."
890813|NCT01118455|P2|Participant Flow|Anti-Epileptic Drug (AED) - ITT Population|Anti-epileptic drug therapy
890814|NCT01118455|P1|Participant Flow|Vagus Nerve Stimulation (VNS) - ITT Population|Vagus Nerve Stimulation (VNS) Therapy
890815|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
890816|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
890817|NCT01118455|O2|Outcome|Anti-Epileptic Drug (AED)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to AED Group.
890818|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS)|Patients who were either treated with >5 AEDs or treated with 2-5 AEDs prior to study entry and were randomized to VNS Therapy.
890819|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
890820|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
890821|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
890822|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
890823|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
890824|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
890825|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
890826|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
890827|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
890828|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
890829|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
890830|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
890831|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
890832|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
890833|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) Non-Early|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
890834|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) Early|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
890835|NCT01118455|O4|Outcome|Anti-Epileptic Drug (AED) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to AED Group.
890836|NCT01118455|O3|Outcome|Anti-Epileptic Drug (AED) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to AED Group.
890837|NCT01118455|O2|Outcome|Vagus Nerve Stimulation (VNS) - Non-Early Group|Patients who were treated with >5 AEDs prior to study entry who were randomized to VNS Therapy.
890838|NCT01118455|O1|Outcome|Vagus Nerve Stimulation (VNS) - Early Group|Patients who were treated with 2-5 AEDs prior to study entry who were randomized to VNS Therapy.
890839|NCT01118455|E2|Reported Event|Anti-Epileptic Drug (AED) - Safety Population|"This arm will supply a comparison between VNS and new AEDs which is necessary to determine an overall treatment regimen for the 30% to 40% of patients who fail to respond to 2 AEDs.~All subjects were considered evaluable for tolerability and safety after initiation of adjunctive AED treatment."
890840|NCT01118455|E1|Reported Event|Vagus Nerve Stimulation (VNS) Therapy - Safety Population|"Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.~All subjects were considered evaluable for tolerability and safety after implantation of the VNS Therapy System.~NOTE: Number of participants analyzed in VNS safety population includes one patient explanted that did not receive stimulation and was therefore excluded from ITT population."
890841|NCT01118377|B1|Baseline|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
890842|NCT01118377|P1|Participant Flow|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
890843|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
890844|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
890845|NCT01118377|O1|Outcome|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
890846|NCT01118377|E1|Reported Event|Capecitabine + Radiation Therapy|Participants received 9 weeks of capecitabine 650 mg/m^2 orally (po) twice daily (bid) plus radiation therapy (180 cGy/day 5 days a week, total target dose of 56 Gy) followed by a 2-week rest period. Participants then received 3 cycles of capecitabine 1250 mg/m^2 po bid for 14 days followed by a 7-day rest period without radiation therapy.
890847|NCT01118325|B4|Baseline|Total|Total of all reporting groups
890848|NCT01118325|B3|Baseline|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890849|NCT01118325|B2|Baseline|AZD6140 90 mg bd|AZD6140 90 mg twice daily
890850|NCT01118325|B1|Baseline|AZD6140 45 mg bd|AZD6140 45 mg twice daily
890851|NCT01118325|P3|Participant Flow|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890852|NCT01118325|P2|Participant Flow|AZD6140 90 mg bd|AZD6140 90 mg twice daily
890853|NCT01118325|P1|Participant Flow|AZD6140 45 mg bd|AZD6140 45 mg twice daily
890854|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
890855|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese Patients
890856|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
890857|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese Patients
890858|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
890859|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
890860|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
890861|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
890862|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Jpanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
890863|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
890864|NCT01118325|O2|Outcome|AZD6140 45mg bd in Non-Jpanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
890865|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
890866|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
890867|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
890868|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
890869|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
890870|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
890871|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
890872|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
890873|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
890874|NCT01118325|O4|Outcome|AZD6140 90 mg bd in Non-Japanese Patients|AZD6140 90 mg twice daily in non-Japanese patients
890875|NCT01118325|O3|Outcome|AZD6140 90 mg bd in Japanese Patients|AZD6140 90 mg twice daily in Japanese patients
890876|NCT01118325|O2|Outcome|AZD6140 45 mg bd in Non-Japanese Patients|AZD6140 45 mg twice daily in non-Japanese patients
890877|NCT01118325|O1|Outcome|AZD6140 45 mg bd in Japanese Patients|AZD6140 45 mg twice daily in Japanese patients
890878|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890879|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily
890880|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily
890887|NCT01118325|O3|Outcome|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890888|NCT01118325|O2|Outcome|AZD6140 90 mg bd|AZD6140 90 mg twice daily in Japanese patients
890889|NCT01118325|O1|Outcome|AZD6140 45 mg bd|AZD6140 45 mg twice daily in Japanese patients
890893|NCT01118325|E3|Reported Event|Clopidogrel 75 mg od|Clopidogrel 75 mg once daily
890894|NCT01118325|E2|Reported Event|AZD6140 90 mg bd|AZD6140 90 mg twice daily
890895|NCT01118325|E1|Reported Event|AZD6140 45 mg bd|AZD6140 45 mg twice daily
890896|NCT01118312|B3|Baseline|Total|Total of all reporting groups
890897|NCT01118312|B2|Baseline|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
890898|NCT01118312|B1|Baseline|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
890899|NCT01118312|P2|Participant Flow|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
890900|NCT01118312|P1|Participant Flow|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
890901|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
890902|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
890903|NCT01118312|O2|Outcome|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
890904|NCT01118312|O1|Outcome|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
890905|NCT01118312|E2|Reported Event|Placebo|"Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Placebo: Intranasal placebo spray"
890906|NCT01118312|E1|Reported Event|Nasal Steroid|"Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day~Mometasone Furoate monohydrate: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months"
890907|NCT01118273|B7|Baseline|Total|Total of all reporting groups
890908|NCT01118273|B6|Baseline|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890909|NCT01118273|B5|Baseline|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890910|NCT01118273|B4|Baseline|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890911|NCT01118273|B3|Baseline|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890912|NCT01118273|B2|Baseline|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890913|NCT01118273|B1|Baseline|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890914|NCT01118273|P6|Participant Flow|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890915|NCT01118273|P5|Participant Flow|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890916|NCT01118273|P4|Participant Flow|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890917|NCT01118273|P3|Participant Flow|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890918|NCT01118273|P2|Participant Flow|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890919|NCT01118273|P1|Participant Flow|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890920|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890921|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890922|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890923|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890924|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890925|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891113|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
890926|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890927|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890928|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890929|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890930|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890931|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890932|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890933|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890934|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890935|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890936|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890937|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890938|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890939|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890940|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890941|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890942|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890943|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890944|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890945|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890946|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890947|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890948|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890949|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890950|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890951|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890952|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890953|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890954|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890955|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890956|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890957|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890958|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890959|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890960|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890961|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
895544|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
890962|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890963|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890964|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890965|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890966|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890967|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890968|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890969|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890970|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890971|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890972|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890973|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890974|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890975|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890976|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890977|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890978|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890979|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890980|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890981|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890982|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890983|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890984|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890985|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890986|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890987|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890988|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890989|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890990|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890991|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
890992|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890993|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
890994|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
890995|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
890996|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
890997|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
895545|NCT01104584|O1|Outcome|CMRM vs UMRM|
890998|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
890999|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891000|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891001|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891002|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891003|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891004|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891005|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891006|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891007|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891008|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891009|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891010|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891011|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891012|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891013|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891014|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891015|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891016|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891017|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891018|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891019|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891020|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891021|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891022|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891023|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891024|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891025|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891026|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891027|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891028|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891029|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891030|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891031|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891032|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891033|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
895546|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
891034|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891035|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891036|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891037|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891038|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891039|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891040|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891041|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891042|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891043|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891044|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891045|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891046|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891047|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891048|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891049|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891050|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891051|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891052|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891053|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891054|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891055|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891056|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891057|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891058|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891059|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891060|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891061|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891062|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891063|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891064|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891065|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891066|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891067|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891068|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891069|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
895547|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
891070|NCT01118273|O6|Outcome|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891071|NCT01118273|O5|Outcome|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891072|NCT01118273|O4|Outcome|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891073|NCT01118273|O3|Outcome|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891074|NCT01118273|O2|Outcome|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891075|NCT01118273|O1|Outcome|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891076|NCT01118273|E6|Reported Event|Ibuprofen 400 mg / Diphenhydramine Citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
891077|NCT01118273|E5|Reported Event|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
891078|NCT01118273|E4|Reported Event|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
891079|NCT01118273|E3|Reported Event|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|Participants received 1 tablet of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 1 tablet of placebo, single dose, orally.
891080|NCT01118273|E2|Reported Event|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
891081|NCT01118273|E1|Reported Event|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
891082|NCT01118221|B3|Baseline|Total|Total of all reporting groups
891083|NCT01118221|B2|Baseline|Control|no structured exercise
891084|NCT01118221|B1|Baseline|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
891085|NCT01118221|P2|Participant Flow|Control|no structured exercise
891086|NCT01118221|P1|Participant Flow|Pulmonary Rehabilitation|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
891087|NCT01118221|O2|Outcome|Control Group|no structured exercise
891088|NCT01118221|O1|Outcome|Rehabilitation Group|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
891089|NCT01118221|O2|Outcome|After Exercise Testing|Plasma isoprostanes after exercise testing.
891090|NCT01118221|O1|Outcome|Before Exercise Testing|Plasma isoprostanes before exercise test.
891091|NCT01118221|O2|Outcome|Arm 2|no structured exercise
891092|NCT01118221|O1|Outcome|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
891093|NCT01118221|E2|Reported Event|Arm 2|no structured exercise
891094|NCT01118221|E1|Reported Event|Arm 1|"enroll in pulmonary rehabilitation program~pulmonary rehabilitation: structured exercise program"
891095|NCT01118143|B3|Baseline|Total|Total of all reporting groups
891096|NCT01118143|B2|Baseline|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
891097|NCT01118143|B1|Baseline|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
891098|NCT01118143|P2|Participant Flow|Control: Short Standard Information|Participants in the control group got short standard information after the clinical measurement, as usual in general dental clinical practice. E.g. If there was gingival bleeding, participants got a message that their gums were bleeding and that dental floss was recommended.
891099|NCT01118143|P1|Participant Flow|Experiment: Communication Adapted to Health Literacy Level|Participants in the experimental group got individualized communication regarding their oral health. The communication was adapted to the measured Health Literacy level of each participant. Health Literacy communication theory was utilized in order to adapt the communication to the participants Health literacy level. Two-way communication with use of models, illustrative pictures and teach-back method was emphasized. Up to 30 minutes was available for this intervention conversation.
891100|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
891101|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|The effect of intervention is evaluated using measures of plaque index
891102|NCT01118143|O2|Outcome|Ordinary Oral Health Instruction|Oral health instruction commonly used in general practice
891103|NCT01118143|O1|Outcome|Individualized Oral Health Instruction|Individualized oral health instruction adapted to the patients oral health literacy level
891104|NCT01118143|E2|Reported Event|Control|The oral health instruction is according to standard clinical practice
891105|NCT01118143|E1|Reported Event|Individualized Oral Health Instruction|The oral health instruction is individualized according to the patients oral health literacy level
891106|NCT01118117|B3|Baseline|Total|Total of all reporting groups
891107|NCT01118117|B2|Baseline|Long Length (150mm) Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
891108|NCT01118117|B1|Baseline|Misago™ Self-Expanding Stent System|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891109|NCT01118117|P2|Participant Flow|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
891110|NCT01118117|P1|Participant Flow|Misago™ Self-Expanding Stent System|Subjects received treatment with the Misago™ Self-Expanding Stent
891111|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891112|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891114|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891115|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
891116|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891117|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
891118|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891119|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891120|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891121|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891122|NCT01118117|O2|Outcome|Long Length Stent Sub-Study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150mm intravascular stent
891123|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891124|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891125|NCT01118117|O1|Outcome|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891126|NCT01118117|E2|Reported Event|Long Length Stent Sub-study Cohort|Misago™ Self-Expanding Stent System: Transcatheter placement of a single, 150 mm intravascular stent
891127|NCT01118117|E1|Reported Event|Non-Randomized|Misago™ Self-Expanding Stent System: Transcatheter placement of an intravascular stent(s)
891128|NCT01118091|B3|Baseline|Total|Total of all reporting groups
891129|NCT01118091|B2|Baseline|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
891130|NCT01118091|B1|Baseline|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
891131|NCT01118091|P2|Participant Flow|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
891132|NCT01118091|P1|Participant Flow|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
891133|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
891134|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
891135|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
891136|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
891179|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
891137|NCT01118091|O2|Outcome|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
891149|NCT01117987|B3|Baseline|Total|Total of all reporting groups
891138|NCT01118091|O1|Outcome|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
891139|NCT01118091|E2|Reported Event|Arm 2 - Adoptive Cell Therapy|"Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x10^8) and the administration of high-dose aldesleukin.~CD8 enriched Young TIL : Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin."
891140|NCT01118091|E1|Reported Event|Arm 1 - Aldesleukin|"Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.~Aldesleukin : Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin."
891141|NCT01118013|B1|Baseline|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891142|NCT01118013|P1|Participant Flow|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891143|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891144|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891145|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891146|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891147|NCT01118013|O1|Outcome|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891180|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
891181|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
891148|NCT01118013|E1|Reported Event|Treatment|"Participants will receive:~Busulfan test dose of 25 mg/m^2 IV over 45 minutes between days -14 and -9; Fludarabine 30 mg/m^2/day IV over 30 minutes on days -7 to -3; Busulfan IV x 4 days on days -6 through -3 (dosage based on AUC of 4000 mmol/min based on pharmacokinetics determined from test dose); Allopurinol was given at discretion of treating physician; Rabbit antithymocyte globulin 1.5 mg/kg/day IV on days -6 and -5; Peripheral Blood Stem Cell Transplant (PBST) on Day 0 and +1; and methotrexate 5 mg/m^2/day IV on days +1, +3 and +6. G-CSF of 5mcg/kg/day SQ began daily on day +7 continuing until ANC > 1000/mL for 3 consecutive days."
891150|NCT01117987|B2|Baseline|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891151|NCT01117987|B1|Baseline|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891152|NCT01117987|P2|Participant Flow|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891153|NCT01117987|P1|Participant Flow|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891154|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891155|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891156|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891157|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891158|NCT01117987|O2|Outcome|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891159|NCT01117987|O1|Outcome|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891160|NCT01117987|E2|Reported Event|Core Placebo|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891161|NCT01117987|E1|Reported Event|Core Imatinib|Depending on the participants randomized treatment in the core study, CQTI571A2301 (NCT00902174), and their completion status in the core study, participants received imatinib at 200 mg qd, 400 mg qd, or 200 mg qd with an increase to 400 mg qd after 2 weeks, if tolerated.
891162|NCT01117948|B3|Baseline|Total|Total of all reporting groups
891163|NCT01117948|B2|Baseline|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891164|NCT01117948|B1|Baseline|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891165|NCT01117948|P2|Participant Flow|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891166|NCT01117948|P1|Participant Flow|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891167|NCT01117948|O2|Outcome|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891168|NCT01117948|O1|Outcome|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891169|NCT01117948|E2|Reported Event|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891170|NCT01117948|E1|Reported Event|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
891171|NCT01117870|B3|Baseline|Total|Total of all reporting groups
891172|NCT01117870|B2|Baseline|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
891173|NCT01117870|B1|Baseline|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
891174|NCT01117870|P2|Participant Flow|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
891175|NCT01117870|P1|Participant Flow|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
891176|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
891177|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
891178|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
891182|NCT01117870|O2|Outcome|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius~The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
891207|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891507|NCT01117012|B2|Baseline|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891183|NCT01117870|O1|Outcome|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.~The study of the efficacy of cervical PRF-DRG showed significant results favoring PRF-DRG for a 20% pain reduction in VAS score. It has been noted that a 30% reduction in pain appears to reflect at least a moderate clinically important difference, and this needs to be considered in clinical trials."
891184|NCT01117870|O1|Outcome|Lost to Follow-up Patients|Patients who were lost to follow-up at 3 months
891185|NCT01117870|O1|Outcome|Eligible Patients|Patients meeting eligibility criteria
891186|NCT01117870|E2|Reported Event|PRF Treatment|"PRF will be applied for 120 seconds at 42 degrees celsius.~Pulsed RadioFrequency: 120 seconds at 42 degrees celsius"
891187|NCT01117870|E1|Reported Event|Placebo|"The needle will be continuously stimulated at a low voltage to give a sensation of PRF treatment.~Placebo: Needle will be continuously stimulated at a low voltage to give a sensation of PRF application."
891188|NCT01117857|B1|Baseline|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891189|NCT01117857|P1|Participant Flow|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891190|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891191|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891192|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891193|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891194|NCT01117857|O1|Outcome|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891195|NCT01117857|E1|Reported Event|Duloxetine|"After a one-week placebo lead-in, all eligible subjects will receive Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg Duloxetine per day for 7 weeks.~Duloxetine: One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study."
891196|NCT01117766|B1|Baseline|All Participants|Includes all participants randomized to receive pregabalin first and placebo first.
891197|NCT01117766|P2|Participant Flow|Placebo Then Pregabalin|Participants took placebo to match the pregabalin doses BID during the first 4- week treatment period. Then after a 2-week washout period, participants were titrated up to 300 mg pregabalin BID for the first 2 weeks and then remained at 300 mg BID for the duration of the second 4-week treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891198|NCT01117766|P1|Participant Flow|Pregabalin Then Placebo|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg twice daily (BID) for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later. Then after a 2-week washout period, participants took placebo to match the pregabalin doses BID during a 4-week treatment period.
891199|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891200|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891201|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891202|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891203|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891204|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891205|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891206|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891208|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891209|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891210|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891211|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891212|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891213|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891214|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891215|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891216|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891217|NCT01117766|O2|Outcome|Placebo|Participants took placebo to match the pregabalin doses BID.
891218|NCT01117766|O1|Outcome|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891219|NCT01117766|E2|Reported Event|Placebo|Participants took placebo to match the pregabalin doses BID.
891220|NCT01117766|E1|Reported Event|Pregabalin|During the 4-week pregabalin treatment period, participants were titrated up to 300 mg BID for the first 2 weeks and then remained at 300 mg BID for the duration of the treatment period. Participants took a dose each morning and the evening dose approximately 12 hours later.
891221|NCT01117727|B1|Baseline|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
891222|NCT01117727|P1|Participant Flow|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
891223|NCT01117727|O2|Outcome|Pilot Testing With Scan Rate at 2 Stdev|Pilot testing with scan rate set at twice the standard deviation of the reaction time.
891224|NCT01117727|O1|Outcome|Pilot Testing, 0.65 Scan Rate|Pilot subject testing protocol with scan rate at 0.65 seconds per item.
891225|NCT01117727|E1|Reported Event|Pilot Testing|Brain Computer Interface Switch: Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
891226|NCT01117623|B9|Baseline|Total|Total of all reporting groups
891227|NCT01117623|B8|Baseline|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891228|NCT01117623|B7|Baseline|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891229|NCT01117623|B6|Baseline|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891230|NCT01117623|B5|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891231|NCT01117623|B4|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891415|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891232|NCT01117623|B3|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891786|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
891233|NCT01117623|B2|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891234|NCT01117623|B1|Baseline|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891235|NCT01117623|P8|Participant Flow|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891236|NCT01117623|P7|Participant Flow|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891237|NCT01117623|P6|Participant Flow|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891238|NCT01117623|P5|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891239|NCT01117623|P4|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891240|NCT01117623|P3|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891241|NCT01117623|P2|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891242|NCT01117623|P1|Participant Flow|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral co-precipitate (CP) tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891243|NCT01117623|O2|Outcome|NSCLC Expansion Cohort, Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891244|NCT01117623|O1|Outcome|HCC Expansion Cohort, Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891245|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891246|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891416|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891780|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
891247|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891248|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891249|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891250|NCT01117623|O2|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891251|NCT01117623|O1|Outcome|HCC Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A or B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891252|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891253|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891254|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891255|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891256|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891257|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891258|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891259|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891260|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891261|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891417|NCT01117350|O1|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891454|NCT01117311|B1|Baseline|Entire Study Population|Includes groups randomized to have the VNB off first and the VNB on first.
895548|NCT01104584|O1|Outcome|CMRM vs UMRM|
891262|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891263|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891264|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891265|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891266|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891267|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891268|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891269|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891270|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891271|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891272|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891273|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891274|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891275|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891276|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891322|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891354|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891277|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891278|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891279|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891280|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891281|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891282|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891283|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891284|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891285|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891286|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891287|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891288|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891289|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891290|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891291|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891338|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891292|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891293|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891294|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891295|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891296|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891297|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891298|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891299|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891300|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891301|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891302|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891303|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891304|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891305|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891306|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891408|NCT01117350|B3|Baseline|Total|Total of all reporting groups
891409|NCT01117350|B2|Baseline|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891500|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
891307|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891308|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891309|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891310|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891311|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891312|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891313|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891314|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891315|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891316|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891317|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891318|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891319|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891320|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891321|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891410|NCT01117350|B1|Baseline|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891501|NCT01117051|O1|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
891323|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891324|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891325|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891326|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891327|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891328|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891329|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891330|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891331|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891332|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891333|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891334|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891335|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891336|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891337|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891411|NCT01117350|P2|Participant Flow|Liraglutide (Comparative Period)/ Insulin Glargine (Extension)|"Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)~For patients included in the extension period: Insulin Glargine (dosing same as above)"
895549|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
891339|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891340|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891341|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891342|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891343|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891344|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891345|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891346|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891347|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891348|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891349|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891350|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891351|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891352|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891353|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891412|NCT01117350|P1|Participant Flow|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891502|NCT01117051|O2|Outcome|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
891355|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891356|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891357|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891358|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891359|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891360|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891361|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891362|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891363|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891364|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891365|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891366|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891367|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891368|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891413|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891503|NCT01117051|O1|Outcome|Placebo|once daily before breakfast for up to 12 weeks
891369|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891370|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891371|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891372|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891373|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891374|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891375|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891376|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891377|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891378|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891379|NCT01117623|O8|Outcome|NSCLC Expansion Cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891380|NCT01117623|O7|Outcome|HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891381|NCT01117623|O6|Outcome|HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A status in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891382|NCT01117623|O5|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891383|NCT01117623|O4|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891414|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891453|NCT01117337|E1|Reported Event|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
891384|NCT01117623|O3|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891385|NCT01117623|O2|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891386|NCT01117623|O1|Outcome|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891387|NCT01117623|O1|Outcome|Regorafenib, 20 mg, 40 mg, 100 mg, 120 mg, 140 mg|Participants in the dose-escalation cohort received a single 20 mg, 40 mg, 100 mg, 120 mg, 140 mg oral CP tablet of regorafenib respectively on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891388|NCT01117623|E5|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891389|NCT01117623|E4|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891390|NCT01117623|E3|Reported Event|Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle. This arm includes the participants from the dose escalation cohort: Regorafenib 100 mg and the three Expansion Cohorts 'HCC Child-Pugh A Expansion Cohort: Regorafenib 100 mg', 'HCC Child-Pugh B Expansion Cohort: Regorafenib 100 mg', 'NSCLC Expansion Cohort: Regorafenib 100 mg'.
891391|NCT01117623|E2|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891392|NCT01117623|E1|Reported Event|Escalation Cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
891393|NCT01117480|B1|Baseline|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
891394|NCT01117480|P1|Participant Flow|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
891395|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
891396|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
891397|NCT01117480|O1|Outcome|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
891398|NCT01117480|E1|Reported Event|Moderate-to-severe Rheumatoid Arthritis|Participants with moderate-to-severe rheumatoid arthritis treated with adalimumab in routine clinical practice
891399|NCT01117454|B3|Baseline|Total|Total of all reporting groups
891400|NCT01117454|B2|Baseline|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
891401|NCT01117454|B1|Baseline|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
891402|NCT01117454|P2|Participant Flow|Placebo Then Flecainide|"In this crossover study, half of the subjects will be randomized to placebo plus standard therapy first, then crossover to flecainide plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
891403|NCT01117454|P1|Participant Flow|Flecainide Then Placebo|"In this crossover study, half of the subjects will be randomized to flecainide plus standard therapy first, then crossover to placebo plus standard therapy.~flecainide: oral flecainide will be added to standard therapy with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml"
891404|NCT01117454|O2|Outcome|Placebo|All participants when receving placebo
891405|NCT01117454|O1|Outcome|Flecainide|All participants when receiving flecainide
891406|NCT01117454|E2|Reported Event|Placebo|All participants when receving placebo
891407|NCT01117454|E1|Reported Event|Flecainide|All participants when receiving flecainide
891418|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891506|NCT01117012|B3|Baseline|Total|Total of all reporting groups
891787|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
891419|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891420|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891421|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891422|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891423|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891424|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891425|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891426|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891427|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891428|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891429|NCT01117350|O1|Outcome|Insulin Glargine (Extension Period)|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891430|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891431|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891432|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891433|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891434|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891435|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891436|NCT01117350|O2|Outcome|Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24.
891437|NCT01117350|O1|Outcome|Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days.
891438|NCT01117350|E3|Reported Event|Extension Period: Insulin Glargine|"Following a treatment with liraglutide during the comparative period, those patients have received insulin glargine during the extension period.~Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days"
891439|NCT01117350|E2|Reported Event|Comparative Period: Liraglutide|Liraglutide dose: 0.6 mg/day during the first week, 1.2 mg/day during the second week and 1.8 mg/day until week 24 (comparative period)
891440|NCT01117350|E1|Reported Event|Comparative Period: Insulin Glargine|Insulin glargine starting dose: 0.2 Unit per kilogram of body weight or 10 Units. Insulin titration (by 2 or 4 Units) every 3 days according to the median value of Fast Plasma Glucose of the last 3 days
891441|NCT01117337|B3|Baseline|Total|Total of all reporting groups
891442|NCT01117337|B2|Baseline|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
891443|NCT01117337|B1|Baseline|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
891444|NCT01117337|P2|Participant Flow|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
891445|NCT01117337|P1|Participant Flow|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
891446|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
891447|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
891448|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
891449|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
891450|NCT01117337|O2|Outcome|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
891451|NCT01117337|O1|Outcome|Mesh Fixation Group|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is fixed with two tackers
891452|NCT01117337|E2|Reported Event|Mesh Non Fixation Group|The patients in whom the mesh was not fixed by any means
891781|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
891455|NCT01117311|P2|Participant Flow|VNB on First, Then VNB Off|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) on first for the first intervention (Mixed Meal 2), then VNB off for the second intervention (Mixed Meal 3).
891456|NCT01117311|P1|Participant Flow|VNB Off First, Then VNB on|Subjects assigned to this reporting group had the vagal nerve blocker (VNB) off first for the first intervention (Mixed Meal 2), then VNB on for the second intervention (Mixed Meal 3).
891457|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
891458|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
891459|NCT01117311|O2|Outcome|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
891460|NCT01117311|O1|Outcome|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
891461|NCT01117311|E2|Reported Event|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
891462|NCT01117311|E1|Reported Event|VNB Off|The implanted Vagal Nerve Blocker will be off at the time of study.
891463|NCT01117181|B3|Baseline|Total|Total of all reporting groups
891464|NCT01117181|B2|Baseline|Placebo|matching placebo and psychosocial intervention
891465|NCT01117181|B1|Baseline|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
891466|NCT01117181|P2|Participant Flow|Placebo|matching placebo and psychosocial intervention
891467|NCT01117181|P1|Participant Flow|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
891468|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
891469|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
891470|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
891471|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
891472|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
891473|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
891474|NCT01117181|O2|Outcome|Placebo|matching placebo and psychosocial intervention
891475|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
891476|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
891477|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
891478|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
891479|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
891480|NCT01117181|O2|Outcome|Placebo|Placebo and psychosocial intervention
891481|NCT01117181|O1|Outcome|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day), and psychosocial intervention
891482|NCT01117181|E2|Reported Event|Placebo|matching placebo and psychosocial intervention
891483|NCT01117181|E1|Reported Event|Methylphenidate|Methylphenidate, target dose 20 mg per day (range 10-20 mg per day) and psychosocial intervention
891484|NCT01117090|B1|Baseline|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
891485|NCT01117090|P1|Participant Flow|Intrathecal Pump Patients|Subjects previously implanted with an intrathecal pump who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
891486|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of catheter complication from the physician
891487|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to valsalva were analyzable and who received a diagnosis of normal catheter function from the physician
891488|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of catheter complication from the physician
891489|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data in response to cough were analyzable and who received a diagnosis of normal catheter function from the physician
891490|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
891491|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose catheter flow resistance check data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
891492|NCT01117090|O2|Outcome|Subjects With Catheter Complications by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of catheter complication from the physician
891493|NCT01117090|O1|Outcome|Subjects With Normal Catheter Function by Physician Diagnosis|Subjects whose pressure data were analyzable and who received a trouble-shooting diagnosis of normal catheter function from the physician
891494|NCT01117090|E1|Reported Event|Intrathecal Pump Patients|Subjects who satisfied all inclusion and exclusion criteria, provided written informed consent, and had a needle inserted into the catheter access port of the implanted pump were considered to be enrolled in the study
891495|NCT01117051|B3|Baseline|Total|Total of all reporting groups
891496|NCT01117051|B2|Baseline|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
891497|NCT01117051|B1|Baseline|Placebo|placebo once daily before breakfast for up to 12 weeks
891498|NCT01117051|P2|Participant Flow|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
891499|NCT01117051|P1|Participant Flow|Placebo|placebo once daily before breakfast for up to 12 weeks
891504|NCT01117051|E2|Reported Event|Prucalopride|1 or 2 mg prucalopride once daily before breakfast for up to 12 weeks
891505|NCT01117051|E1|Reported Event|Placebo|once daily before breakfast for up to 12 weeks
891508|NCT01117012|B1|Baseline|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891509|NCT01117012|P2|Participant Flow|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891510|NCT01117012|P1|Participant Flow|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 milligram (mg) tablet orally twice daily (q12h).
891511|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891512|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891513|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891514|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891515|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891516|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891517|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891518|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891519|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891520|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891521|NCT01117012|O2|Outcome|VX-770/VX-770|Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891522|NCT01117012|O1|Outcome|Placebo/VX-770|Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
891523|NCT01117012|O1|Outcome|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
891524|NCT01117012|E1|Reported Event|VX-770|All participants who received VX-770 150 mg tablet orally q12h in Study 105.
891525|NCT01116986|B33|Baseline|Total|Total of all reporting groups
891526|NCT01116986|B32|Baseline|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891527|NCT01116986|B31|Baseline|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891528|NCT01116986|B30|Baseline|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891529|NCT01116986|B29|Baseline|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891530|NCT01116986|B28|Baseline|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891531|NCT01116986|B27|Baseline|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891532|NCT01116986|B26|Baseline|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891533|NCT01116986|B25|Baseline|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891534|NCT01116986|B24|Baseline|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891535|NCT01116986|B23|Baseline|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891788|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
891536|NCT01116986|B22|Baseline|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891537|NCT01116986|B21|Baseline|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891538|NCT01116986|B20|Baseline|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
891539|NCT01116986|B19|Baseline|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
891540|NCT01116986|B18|Baseline|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891541|NCT01116986|B17|Baseline|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891542|NCT01116986|B16|Baseline|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891543|NCT01116986|B15|Baseline|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891544|NCT01116986|B14|Baseline|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891545|NCT01116986|B13|Baseline|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891546|NCT01116986|B12|Baseline|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891547|NCT01116986|B11|Baseline|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891548|NCT01116986|B10|Baseline|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891549|NCT01116986|B9|Baseline|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891550|NCT01116986|B8|Baseline|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891551|NCT01116986|B7|Baseline|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891552|NCT01116986|B6|Baseline|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891553|NCT01116986|B5|Baseline|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891554|NCT01116986|B4|Baseline|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891555|NCT01116986|B3|Baseline|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891556|NCT01116986|B2|Baseline|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891557|NCT01116986|B1|Baseline|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891558|NCT01116986|P32|Participant Flow|32, No Patch, No Gum, No Prequit, Int In-Person, Int Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891559|NCT01116986|P31|Participant Flow|31, No Patch, No Gum, No Prequit, Int In-Person, Min Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891560|NCT01116986|P30|Participant Flow|30, No Patch, No Gum, No Prequit, Min In-Person, Int Phone, 8W|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891561|NCT01116986|P29|Participant Flow|29, No Patch, No Gum, No Prequit, Min In-Person, Min Phone, 16|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891562|NCT01116986|P28|Participant Flow|28, No Patch, No Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891563|NCT01116986|P27|Participant Flow|27, No Patch, No Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891564|NCT01116986|P26|Participant Flow|26, No Patch, No Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891565|NCT01116986|P25|Participant Flow|25, No Patch, No Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891566|NCT01116986|P24|Participant Flow|24, No Patch, Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891567|NCT01116986|P23|Participant Flow|23, No Patch, Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891568|NCT01116986|P22|Participant Flow|22, No Patch, Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891569|NCT01116986|P21|Participant Flow|21, No Patch, Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891680|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891782|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
891570|NCT01116986|P20|Participant Flow|20, No Patch, Gum, Prequit, Int In-Person, Int Phone, 16Wk|How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt
891571|NCT01116986|P19|Participant Flow|19, No Patch, Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt."
891572|NCT01116986|P18|Participant Flow|18, No Patch, Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891573|NCT01116986|P17|Participant Flow|17, No Patch, Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? No Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891574|NCT01116986|P16|Participant Flow|16, Patch, No Gum, No Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891575|NCT01116986|P15|Participant Flow|15, Patch, No Gum, No Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891576|NCT01116986|P14|Participant Flow|14, Patch, No Gum, No Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891577|NCT01116986|P13|Participant Flow|13, Patch, No Gum, No Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891578|NCT01116986|P12|Participant Flow|12, Patch, No Gum, Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891579|NCT01116986|P11|Participant Flow|11, Patch, No Gum, Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891580|NCT01116986|P10|Participant Flow|10, Patch, No Gum, Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891581|NCT01116986|P9|Participant Flow|9, Patch, No Gum, Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, No Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891582|NCT01116986|P8|Participant Flow|8, Patch, Gum, No Prequit, Int In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891583|NCT01116986|P7|Participant Flow|7, Patch, Gum, No Prequit, Int In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891584|NCT01116986|P6|Participant Flow|6, Patch, Gum, No Prequit, Min In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891585|NCT01116986|P5|Participant Flow|5, Patch, Gum, No Prequit, Min In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, No Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891586|NCT01116986|P4|Participant Flow|4, Patch, Gum, Prequit, Int In-Person, Int Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891681|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891682|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891638|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891587|NCT01116986|P3|Participant Flow|3, Patch, Gum, Prequit, Int In-Person, Min Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Intensive In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891588|NCT01116986|P2|Participant Flow|2, Patch, Gum, Prequit, Min In-Person, Int Phone, 16Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Intensive Phone counseling during quit attempt, 16Wk Medication duration during quit attempt"
891589|NCT01116986|P1|Participant Flow|1, Patch, Gum, Prequit, Min In-Person, Min Phone, 8Wk|"This arm of the project will address the following question:~How effective is the following Intervention? Prequit Nicotine Patch, Prequit Nicotine Gum, Counseling before quit attempt, Minimal In-person counseling during quit attempt, Minimal Phone counseling during quit attempt, 8Wk Medication duration during quit attempt"
891590|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
891591|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
891592|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
891593|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
891594|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
891595|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
891683|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
892082|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
891596|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
891597|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
891598|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
891599|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
891600|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
891601|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
891602|NCT01116986|O12|Outcome|Long Term (26 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Long Term Combo NRT group consists of 304 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=333; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
891610|NCT01116986|O4|Outcome|Pre-Quit Nicotine Gum|Participants randomized to this condition received Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Gum group consists of 339 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Gum (N=298; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
891603|NCT01116986|O11|Outcome|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt. The Short Term Combo NRT group consists of 333 participants (approximately half the total sample of 637) who will be compared with a group that received Long Term Combo NRT group (N=304; approximately half the total sample) in a main effect statistical comparison (Short Term Combo NRT vs. Long Term Combo NRT).
891604|NCT01116986|O10|Outcome|Intensive Phone Counseling During the Quit Attempt|Participants randomized to this condition received Intensive Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive Phone Counseling During the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal Phone Counseling During the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
891605|NCT01116986|O9|Outcome|Minimal Phone Counseling During the Quit Attemp|Participants randomized to this condition received Minimal Phone Counseling During the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal Phone Counseling During the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive Phone Counseling During the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (Minimal Phone Counseling During the Quit Attempt vs Intensive Phone Counseling During the Quit Attempt).
891606|NCT01116986|O8|Outcome|Intensive In-person Counseling During the Quit Attempt|Participants randomized to this condition received Intensive In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Intensive In-person Counseling During the Quit Attempt group consists of 314 participants (approximately half the total sample of 637) who will be compared with a group that received Minimal In-person Counseling During the Quit Attempt (N=323; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
891607|NCT01116986|O7|Outcome|Minimal In-person Counseling During the Quit Attempt|Participants randomized to this condition received Minimal In-person Counseling During the Quit Attempt; participants in this group received all combinations of the other 5 study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Minimal In-person Counseling During the Quit Attempt group consists of 323 participants (approximately half the total sample of 637) who will be compared with a group that received Intensive In-person Counseling During the Quit Attempt(N=320; approximately half the total sample) in a main effect statistical comparison (Minimal In-person Counseling During the Quit Attempt vs Intensive In-person Counseling During the Quit Attempt).
891608|NCT01116986|O6|Outcome|Counseling Before the Quit Attempt|Participants randomized to this condition received Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Counseling Before the Quit Attempt group consists of 317 participants (approximately half the total sample of 637) who will be compared with a group that received No Counseling Before the Quit Attempt (N=320; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
891609|NCT01116986|O5|Outcome|No Counseling Before the Quit Attempt|Participants randomized to this condition received No Counseling Before the Quit Attempt; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Counseling Before the Quit Attempt group consists of 320 participants (approximately half the total sample of 637) who will be compared with a group that received Counseling Before the Quit Attempt (N=317; approximately half the total sample) in a main effect statistical comparison (No Counseling Before the Quit Attempt vs. Counseling Before the Quit Attempt).
891636|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891637|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891611|NCT01116986|O3|Outcome|No Pre-Quit Nicotine Gum|Participants randomized to this condition received No Pre-Quit Nicotine Gum; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Patch or Pre-Quit Nicotine Patch; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Gum group consists of 298 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Gum (N=339; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Gum vs. Pre-Quit Nicotine Gum).
891612|NCT01116986|O2|Outcome|Pre-Quit Nicotine Patch|Participants randomized to this condition received Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The Pre-Quit Nicotine Patch group consists of 329 participants (approximately half the total sample of 637) who will be compared with a group that received No Pre-Quit Nicotine Patch (N=308; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
891613|NCT01116986|O1|Outcome|No Pre-Quit Nicotine Patch|Participants randomized to this condition received No Pre-Quit Nicotine Patch; participants in this group received all combinations of the other five study treatments: No Pre-Quit Nicotine Gum or Pre-Quit Nicotine Gum; No Counseling Before the Quit Attempt or Counseling Before the Quit Attempt; Minimal In-person Counseling During the Quit Attempt or Intensive In-person Counseling During the Quit Attempt; Minimal Phone Counseling During the Quit Attempt or Intensive Phone Counseling During the Quit Attempt; Short Term or Long Term Nicotine Patch + Nicotine Gum During the Quit Attempt. The No Pre-Quit Nicotine Patch group consists of 308 participants (approximately half the total sample of 637) who will be compared with a group that received Pre-Quit Nicotine Patch (N=329; approximately half the total sample) in a main effect statistical comparison (No Pre-Quit Nicotine Patch vs. Pre-Quit Nicotine Patch).
891614|NCT01116986|E6|Reported Event|Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Short Term (8 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Short Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
891615|NCT01116986|E5|Reported Event|Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum|"Long Term (16 Weeks) Postquit Nicotine Patch + Nicotine Gum~Participants randomized to this condition received Long Term Nicotine Patch + Nicotine Gum (Combo NRT) During the Quit Attempt."
891616|NCT01116986|E4|Reported Event|No Pre-Quit Nicotine Patch Nor Gum|"No Pre-Quit Nicotine Patch nor Gum~Participants randomized to this condition received neither the Pre-Quit Nicotine Patch nor the Pre-Quit Nicotine Gum."
891617|NCT01116986|E3|Reported Event|Pre-Quit Nicotine Gum|"Pre-Quit Nicotine Gum~Participants randomized to this condition received Pre-Quit Nicotine Gum.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
891618|NCT01116986|E2|Reported Event|Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Patch.~Before quitting: Everyone had one 14 mg nicotine patch per day for 2 weeks before the target quit day."
891619|NCT01116986|E1|Reported Event|Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch|"Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch~Participants randomized to this condition received Pre-Quit Nicotine Gum and Pre-Quit Nicotine Patch.~Before quitting: Everyone had ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day."
891620|NCT01116934|B3|Baseline|Total|Total of all reporting groups
891621|NCT01116934|B2|Baseline|Healthy Controls|9 healthy donors
891622|NCT01116934|B1|Baseline|PLS Patients|8 PLS patients (one female) from 6 families
891623|NCT01116934|P2|Participant Flow|Healthy Controls|9 healthy donors
891624|NCT01116934|P1|Participant Flow|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
891625|NCT01116934|O2|Outcome|Healthy Controls|9 healthy donors
891626|NCT01116934|O1|Outcome|Papillon-Lefèvre Syndrome (PLS) Patients|8 PLS patients (one female) from 6 families
891627|NCT01116934|E2|Reported Event|Healthy Controls|9 healthy donors
891628|NCT01116934|E1|Reported Event|PLS Patients|8 PLS patients (one female) from 6 families
891629|NCT01116921|B3|Baseline|Total|Total of all reporting groups
891630|NCT01116921|B2|Baseline|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891631|NCT01116921|B1|Baseline|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891632|NCT01116921|P2|Participant Flow|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891633|NCT01116921|P1|Participant Flow|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891634|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891635|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891678|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891679|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891639|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891640|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891641|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891642|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891643|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891644|NCT01116921|O2|Outcome|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891645|NCT01116921|O1|Outcome|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891646|NCT01116921|E2|Reported Event|LMA Group|"Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.~Laryngeal Mask Airway (LMA) to deliver surfactant: Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)"
891647|NCT01116921|E1|Reported Event|nCPAP Control Group|Nasal continuous positive airway pressure (nCPAP): nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
891648|NCT01116882|B3|Baseline|Total|Total of all reporting groups
891649|NCT01116882|B2|Baseline|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891650|NCT01116882|B1|Baseline|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891651|NCT01116882|P2|Participant Flow|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891652|NCT01116882|P1|Participant Flow|PCI at a Hospital Without On-site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891653|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891654|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891655|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891656|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891657|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891658|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891659|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891660|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891661|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891662|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891663|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
891664|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
891665|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
891666|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
891667|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891668|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891669|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery in the angiographic cohort
891670|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery in the angiographic cohort
891671|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891672|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891673|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891674|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891675|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891676|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery.
891677|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
891684|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891685|NCT01116882|O2|Outcome|PCI at Hospital With On-Site Cardiac Surgery|Assigned to PCI at a hospital with on-site cardiac surgery
917344|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
891686|NCT01116882|O1|Outcome|PCI at Hospitals Without On-Site Cardiac Surgery|Assigned to PCI at a hospital without on-site cardiac surgery
891687|NCT01116882|E2|Reported Event|Surgery-On-Site (SOS)|Patients randomized to the SOS arm are transferred to tertiary hospitals for their PCI procedure.
891688|NCT01116882|E1|Reported Event|Non-Surgery-On-Site (Non-SOS)|Patients in the non-SOS arm are randomized to stay at the community hospitals for their PCI procedure.
891689|NCT01116687|B1|Baseline|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
891690|NCT01116687|P1|Participant Flow|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
891691|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
891692|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
891693|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
891694|NCT01116687|O1|Outcome|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
891695|NCT01116687|E1|Reported Event|Investigational Drug Therapy|RO4929097 20 mg by mouth 3 days on 4 days off continuously.
891696|NCT01116466|B1|Baseline|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891697|NCT01116466|P1|Participant Flow|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891698|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891699|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891700|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891701|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891702|NCT01116466|O1|Outcome|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891703|NCT01116466|E1|Reported Event|ActiGait - Implantable Drop Foot Stimulator|Subjects came with conventional walking aid and then received ActiGait implant
891704|NCT01116427|B3|Baseline|Total|Total of all reporting groups
891705|NCT01116427|B2|Baseline|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891706|NCT01116427|B1|Baseline|Abatacept First, Then Placebo|Subjects received abatacept IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows: Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891707|NCT01116427|P2|Participant Flow|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891708|NCT01116427|P1|Participant Flow|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891709|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891710|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891711|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891712|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891783|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
891784|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
891785|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
891713|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891714|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891715|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891716|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891717|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891718|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891719|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891720|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891721|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891722|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891723|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891724|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891725|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891726|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891727|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891728|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891729|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891730|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891731|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891732|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891733|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891734|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891735|NCT01116427|O2|Outcome|Placebo First, Then Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows. Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891736|NCT01116427|O1|Outcome|Abatacept First, Then Placebo|Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. After week 24, participants eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Participants completed an additional 12 weeks of observation until week 64. Dosing of abatacept was as follows:Participants weighing less than 60 kg received 500 mg; 60-100 kg received 750 mg; and greater than 100 kg received 1 g.
891737|NCT01116427|E6|Reported Event|Follow-up Phase: Placebo -> Abatacept|Following Week 52, participants in the Placebo -> Abatacept group completed an additional 12 weeks of observation until week 64.
891738|NCT01116427|E5|Reported Event|Follow-up Phase: Abatacept -> Placebo|Following Week 52, participants in the Abatacept -> Placebo group completed an additional 12 weeks of observation until week 64.
891739|NCT01116427|E4|Reported Event|Extension Phase: Placebo -> Abatacept|"After week 24, participants in the Placebo -> Abatacept group eligible for the extension phase of the trial received abatacept IV on weeks 28, 30, and 32 then every 4 weeks until week 52. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
891740|NCT01116427|E3|Reported Event|Extension Phase: Abatacept -> Placebo|After week 24, participants in Abatacept -> Placebo group eligible for the extension phase of the trial received placebo IV on weeks 28, 30, and 32 then every 4 weeks until week 52.
891741|NCT01116427|E2|Reported Event|Core Phase: Placebo -> Abatacept|Subjects received placebo IV at weeks 0, 2, and 4, and then every 4 weeks through week 24.
891742|NCT01116427|E1|Reported Event|Core Phase: Abatacept -> Placebo|"Subjects received abatacept intravenously (IV) at weeks 0, 2, and 4, and then every 4 weeks through week 24. Dosing of abatacept was as follows:~Participants weighing-~less than 60 kg received 500 mg;~60-100 kg received 750 mg; and~greater than 100 kg received 1 g."
891775|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
891776|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
891777|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
891778|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
891779|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
891743|NCT01116232|B1|Baseline|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
891744|NCT01116232|P1|Participant Flow|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
891745|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"Anti-thymocyte globulin infuse the 1st dose, minimum of 6 hrs subsequent doses minimum of 4 hrs via a 0.22 micron in-line filter~Rituximab, total dose is 28 mg/kg divided in 2 doses (14 mg/kg, days -7 & +3) Initial infusion, start rate 50 mg/hour~Sirolimus 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus (IV) dose of 0.03 mg/kg (ideal body weight) every 24hr by continuous infusion starting on Day -3, discontinued once the pt. starts eating & the drug will then be given orally at a dose of approximately 4 times the IV dose."
891746|NCT01116232|O1|Outcome|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
891747|NCT01116232|E1|Reported Event|Anti-thymocyte Globulin, Rituximab, Sirolimus, Tacrolimus,|"anti-thymocyte globulin: Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter~Rituximab: The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour;~For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).~Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.~peripheral blood stem cell transplantation~sirolimus: For adults, will be administered at 12 mg orally loading dose on day -3, follow"
891748|NCT01116102|B9|Baseline|Total|Total of all reporting groups
891749|NCT01116102|B8|Baseline|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
891750|NCT01116102|B7|Baseline|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
891751|NCT01116102|B6|Baseline|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
891752|NCT01116102|B5|Baseline|25 ga Needle, Dose Flush, Single-step Rate Scheme|
891753|NCT01116102|B4|Baseline|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
891754|NCT01116102|B3|Baseline|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
891755|NCT01116102|B2|Baseline|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
891756|NCT01116102|B1|Baseline|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
891757|NCT01116102|P8|Participant Flow|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
891758|NCT01116102|P7|Participant Flow|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
891759|NCT01116102|P6|Participant Flow|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
891760|NCT01116102|P5|Participant Flow|25 ga Needle, Dose Flush, Single-step Rate Scheme|
891761|NCT01116102|P4|Participant Flow|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
891762|NCT01116102|P3|Participant Flow|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
891763|NCT01116102|P2|Participant Flow|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
891764|NCT01116102|P1|Participant Flow|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
891765|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
891766|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
891767|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
891768|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
891769|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
891770|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
891771|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
891772|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
891773|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
891774|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
892083|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
891789|NCT01116102|O8|Outcome|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
891790|NCT01116102|O7|Outcome|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
891791|NCT01116102|O6|Outcome|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
891792|NCT01116102|O5|Outcome|25 ga Needle, Dose Flush, Single-step Rate Scheme|
891793|NCT01116102|O4|Outcome|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
891794|NCT01116102|O3|Outcome|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
891795|NCT01116102|O2|Outcome|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
891796|NCT01116102|O1|Outcome|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
891797|NCT01116102|E8|Reported Event|25 ga Needle, No Dose Flush, Up-titrated Rate Scheme|
891798|NCT01116102|E7|Reported Event|25 ga Needle, Dose Flush, Up-titrated Rate Scheme|
891799|NCT01116102|E6|Reported Event|25 ga Needle, No Dose Flush, Single-step Rate Scheme|
891800|NCT01116102|E5|Reported Event|25 ga Needle, Dose Flush, Single-step Rate Scheme|
891801|NCT01116102|E4|Reported Event|24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme|
891802|NCT01116102|E3|Reported Event|24 ga Catheter, Dose Flush, Up-titrated Rate Scheme|
891803|NCT01116102|E2|Reported Event|24 ga Catheter, No Dose Flush, Single-step Rate Scheme|
891804|NCT01116102|E1|Reported Event|24 ga Catheter, Dose Flush, Single-step Rate Scheme|
891805|NCT01116037|B1|Baseline|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
891806|NCT01116037|P1|Participant Flow|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
891807|NCT01116037|O1|Outcome|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
891808|NCT01116037|O1|Outcome|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
891809|NCT01116037|E1|Reported Event|ATS 3f Aortic Bioprosthesis|"ATS 3f Aortic Bioprosthesis, Model 1000 (equine pericardial bioprosthesis)~ATS 3f Aortic Bioprosthesis: Equine Pericardial Bioprosthesis for replacement of diseased valve"
891810|NCT01116024|B1|Baseline|Aortic Valve Replacement|3f Enable Aortic Bioprosthesis Model 6000
891811|NCT01116024|P1|Participant Flow|ATS 3f Enable Aortic Bioprosthesis Model 6000|ATS 3f Enable Aortic Bioprosthesis Model 6000 : Replacement Aortic Heart Valve
891812|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
891813|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
891814|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
891815|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
891816|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
891817|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
891818|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
891819|NCT01116024|O7|Outcome|5 Years|Effective Orifice Area at 5 years
891820|NCT01116024|O6|Outcome|4 Years|Effective Orifice Area at 4 years
891821|NCT01116024|O5|Outcome|3 Years|Effective Orifice Area at 3 years
891822|NCT01116024|O4|Outcome|2 Years|Effective Orifice Area at 2 years
891823|NCT01116024|O3|Outcome|11-14 Months|Effective Orifice Area at 11-14 months
891824|NCT01116024|O2|Outcome|3-6 Months|Effective Orifice Area at 3-6 months
891825|NCT01116024|O1|Outcome|Discharge|Effective Orifice Area at discharge
891826|NCT01116024|O7|Outcome|5 Years|Gradient at 5 Years
891827|NCT01116024|O6|Outcome|4 Years|Gradient at 4 Years
891828|NCT01116024|O5|Outcome|3 Years|Gradient at 3 Years
891829|NCT01116024|O4|Outcome|2 Years|Gradient at 2 Years
891830|NCT01116024|O3|Outcome|11-14 Months|Gradient at 11-14 months
891831|NCT01116024|O2|Outcome|3-6 Months|Gradient at 3-6 Months
891832|NCT01116024|O1|Outcome|Discharge|Gradient at discharge
891833|NCT01116024|O7|Outcome|NYHA Class 5 Year|NYHA classification after 5 years.
891834|NCT01116024|O6|Outcome|NYHA Class 4 Year|NYHA classification after 4 years.
891835|NCT01116024|O5|Outcome|NYHA Class 3 Year|NYHA classification after 3 years.
891836|NCT01116024|O4|Outcome|NYHA Class 2 Year|NYHA classification after 2 years.
891837|NCT01116024|O3|Outcome|NYHA Class 11-14 Months|NYHA classification after 11-14 months.
891838|NCT01116024|O2|Outcome|NYHA Class 3-6 Months|NYHA classification after 3-6 months.
891839|NCT01116024|O1|Outcome|NYHA Class Preoperative|Preoperative numbers of NYHA classification.
891840|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891841|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891842|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891843|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891844|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891845|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891846|NCT01116024|O1|Outcome|Enable I Model 6000 Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891847|NCT01116024|O1|Outcome|Enable I Model 6000 Valve: Replacement Aortic Heart Valve|Study is single-arm. All subjects analyzed received the Enable I Model 6000 Valve.
891848|NCT01116024|E1|Reported Event|Enable I Model 6000 Valve|Adverse events relating to the study safety endpoints.
891849|NCT01115998|B3|Baseline|Total|Total of all reporting groups
891850|NCT01115998|B2|Baseline|Control Group|Children received usual early intervention services, but no power wheelchair.
891851|NCT01115998|B1|Baseline|Power Wheelchair|
891852|NCT01115998|P2|Participant Flow|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
891853|NCT01115998|P1|Participant Flow|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
891854|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
891855|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
891856|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
891857|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
891858|NCT01115998|O2|Outcome|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
891859|NCT01115998|O1|Outcome|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
891860|NCT01115998|E2|Reported Event|Control Group|The control group did not receive power wheelchairs. They did receive early intervention services as specified on their individualized family service plans.
891861|NCT01115998|E1|Reported Event|Power Wheelchair|Children were provided custom-fitted Invacare Power Tiger power wheelchairs to use in their homes and communities for 12 months. Parents were primarily responsible for providing practice opportunities and instruction, with the children’s early intervention therapists and research staff helping to solve any problems. Parents were asked to: (1) provide the child with daily opportunities to sit in the device with the motor turned on during play; (2) encourage the child to experiment with movement in a relatively large space and not be concerned if the child drove in circles; and (3) avoid telling the child what to do, but rather to let the child ex experiment unless frustrated or unsafe. The importance of parental supervision, as one would supervise any young child, was stressed. The children also received their usual early intervention services, as specified on their individualized family service plans.
891862|NCT01115933|B1|Baseline|XIENCE PRIME SV EECSS|"XIENCE PRIME SV Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
891863|NCT01115933|P1|Participant Flow|XIENCE PRIME SV EECSS|"XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS"
891864|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891865|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891866|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|"XIENCE PRIME SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS"
892084|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
891867|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891868|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891869|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
917345|NCT01037218|O4|Outcome|Placebo|Placebo tablets
891870|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891871|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891872|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS- ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891873|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891874|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891875|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891876|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891877|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891878|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891879|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891880|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891881|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891882|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891883|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891884|NCT01115933|O5|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable/Possible|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
891885|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - ST Definite/Probable|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891886|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - ST Possible|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891887|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - ST Probable|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891888|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - ST Definite|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891889|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891890|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891891|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891892|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891893|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891894|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891895|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891896|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891897|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891898|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891899|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891900|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891901|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891902|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891903|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891904|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891905|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891906|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891907|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891908|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891909|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891910|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891911|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891912|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NTV-NQMI Per Protocol|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891913|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - NTV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891914|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891915|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891916|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891917|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS Non-Target Vessel QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891918|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891919|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891920|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891921|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891922|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891923|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - TV-QMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891924|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - TV-NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891925|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS- TV-QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891926|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891927|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891928|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
891929|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891930|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - NQMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891931|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - QMI Per ARC Definitions|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
891932|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - NQMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891933|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - QMI Per Protocol|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891934|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
891935|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Vascular Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891936|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Cardiac Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891937|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - All Death Per ARC|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891938|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS - Non-Cardiovascular|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
891939|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS - Vascular|XIENCE PRIME SV EECSS : Patients receiving AXIENCE PRIME SV EECSS
891940|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS - Cardiac|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891941|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS ABR Distal|XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
891942|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS ABR Proximal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891943|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS ABR In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891944|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS ABR In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891945|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS LL Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891946|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS LL Proximal|XIENCE PRIME SV EECSS: Patients receivingXIENCE PRIME SV EECSS
891947|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS LL In-stent|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891948|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS LL In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891949|NCT01115933|O4|Outcome|XIENCE PRIME SV EECSS %DS Distal|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891950|NCT01115933|O3|Outcome|XIENCE PRIME SV EECSS %DS Proximal|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891951|NCT01115933|O2|Outcome|XIENCE PRIME SV EECSS %DS In-stent|XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
891952|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS %DS In-segment|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891953|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS EECSS : Patients receiving XIENCE PRIME SV EECSS
891954|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891955|NCT01115933|O1|Outcome|XIENCE PRIME SV EECSS|XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
891956|NCT01115933|E1|Reported Event|AVJ-09-385 SV EECSS|"SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System~AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS"
891957|NCT01115855|B3|Baseline|Total|Total of all reporting groups
891958|NCT01115855|B2|Baseline|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891959|NCT01115855|B1|Baseline|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891960|NCT01115855|P2|Participant Flow|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
892085|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892086|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892087|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
891978|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
917346|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
891961|NCT01115855|P1|Participant Flow|Eplerenone|Participants with estimated glomerular filtration rate (eGFR) greater than or equal to (>=) 50 milliliter per minute divided by 1.73 squared meter (mL/min/1.73m^2) received eplerenone 25 milligram (mg) tablet once daily up to Week 4 and participants with eGFR 30 to less than (<) 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. . From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891962|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891963|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891964|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891965|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891966|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891967|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891968|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891969|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891970|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891971|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891972|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891973|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891974|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891975|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891976|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891977|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891979|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891980|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891981|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891982|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891983|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891984|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891985|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891986|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891987|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891988|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891989|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891990|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891991|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891992|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891993|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891994|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
892088|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892089|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892014|NCT01115738|P1|Participant Flow|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
917347|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
891995|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891996|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891997|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
891998|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
891999|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
892000|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
892001|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
892002|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
892003|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
892004|NCT01115855|O2|Outcome|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
892005|NCT01115855|O1|Outcome|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
892006|NCT01115855|E2|Reported Event|Placebo|Participants with eGFR >=50 mL/min/1.73m^2 received placebo matched with eplerenone tablet orally once daily from up to Week 4 and participants with eGFR 30 to <50 mL/min/1.73m^2 received placebo matched with eplerenone tablet every other day up to Week 4. From Week 4 onward, all participants received placebo matched with eplerenone tablet once daily up to Month 48.
892007|NCT01115855|E1|Reported Event|Eplerenone|Participants with eGFR >=50 mL/min/1.73m^2 received eplerenone 25 mg tablet once daily up to Week 4 and participants with eGFR 30 to < 50 mL/min/1.73m^2 received eplerenone 25 mg tablet every other day up to Week 4. From Week 4 onward, the dose of eplerenone was limited to 50 mg once daily for participants with eGFR >=50 mL/min/1.73 m^2 and 25 mg once daily for participants with eGFR 30 to <50 mL/min/1.73 m^2 up to Month 48.
892008|NCT01115738|B4|Baseline|Total|Total of all reporting groups
892009|NCT01115738|B3|Baseline|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892010|NCT01115738|B2|Baseline|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892011|NCT01115738|B1|Baseline|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892012|NCT01115738|P3|Participant Flow|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892013|NCT01115738|P2|Participant Flow|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892090|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892015|NCT01115738|O6|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892016|NCT01115738|O5|Outcome|600 mg Clopidogrel and 30 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892017|NCT01115738|O4|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 RM|CYP2C19 reduced metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892018|NCT01115738|O3|Outcome|600 mg Clopidogrel and 60 mg Prasugrel - CYP2C19 EM|CYP2C19 extensive metabolizers treated with 600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892019|NCT01115738|O2|Outcome|Placebo and 60 mg Prasugrel -CYP2C19 RM|CYP2C19 reduced metabolizers treated with placebo LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892020|NCT01115738|O1|Outcome|Placebo and 60 mg Prasugrel-CYP2C19 EM|CYP2C19 extensive metabolizers treated with placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892021|NCT01115738|O2|Outcome|Clopidogrel at Baseline - CYP2C19 RM|600-mg clopidogrel LD administered once orally before PCI.
892022|NCT01115738|O1|Outcome|Clopidogrel at Baseline -CYP2C19 EM|600-milligram (mg) clopidogrel loading dose (LD) administered once orally before percutaneous coronary intervention (PCI).
892023|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892024|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892025|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892026|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892027|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892028|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892029|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892030|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892031|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892032|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892033|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892034|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892035|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892036|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892037|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
917348|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
892038|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892039|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892040|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892041|NCT01115738|O3|Outcome|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892042|NCT01115738|O2|Outcome|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892043|NCT01115738|O1|Outcome|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892044|NCT01115738|E3|Reported Event|600-mg Clopidogrel and 30-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 30-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892045|NCT01115738|E2|Reported Event|600-mg Clopidogrel and 60-mg Prasugrel|600-mg clopidogrel LD administered once orally before PCI and 60-mg prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892046|NCT01115738|E1|Reported Event|Placebo and 60-mg Prasugrel|Placebo loading dose (LD) administered once orally before percutaneous coronary intervention (PCI) and 60-milligram (mg) prasugrel LD administered once orally during PCI, followed by 10-mg prasugrel maintenance dose administered orally 24 hours after LD, then every 24 hours for 72 hours.
892047|NCT01115699|B1|Baseline|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
892048|NCT01115699|P1|Participant Flow|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
892049|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
892050|NCT01115699|O1|Outcome|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
892051|NCT01115699|E1|Reported Event|Repetitive Transcranial Magnetic Stimulation|All subjects will receive 10 Hz repetitive transcranial magnetic stimulation (rTMS) applied to the left dorsolateral prefrontal cortex (L-DLPFC) for a fixed-flexible period of 5 treatments per week for up to 6 weeks.
892052|NCT01115673|B4|Baseline|Total|Total of all reporting groups
892053|NCT01115673|B3|Baseline|ACE-0|0 mg Acetaminophen Caplet
892054|NCT01115673|B2|Baseline|ACE-650|650 mg Acetaminophen Caplet
892055|NCT01115673|B1|Baseline|ACE-1000|1000 mg Acetaminophen Caplet
892056|NCT01115673|P3|Participant Flow|ACE-0|0 mg Acetaminophen Caplet
892057|NCT01115673|P2|Participant Flow|ACE-650|650 mg Acetaminophen Caplet
892058|NCT01115673|P1|Participant Flow|ACE-1000|1000 mg Acetaminophen Caplet
892059|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892060|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892061|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892062|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892063|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892064|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892065|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892066|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892067|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892068|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892069|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892070|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892071|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892072|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892073|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892074|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892075|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892076|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892077|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892078|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892079|NCT01115673|O1|Outcome|ACE-1000|1000 mg Acetaminophen Caplet
892080|NCT01115673|O3|Outcome|ACE-0|0 mg Acetaminophen Caplet
892081|NCT01115673|O2|Outcome|ACE-650|650 mg Acetaminophen Caplet
892192|NCT01115660|B2|Baseline|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
892193|NCT01115660|B1|Baseline|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
892194|NCT01115660|P2|Participant Flow|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
892195|NCT01115660|P1|Participant Flow|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
892196|NCT01115660|O2|Outcome|Control|standard of care
892197|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
892198|NCT01115660|O2|Outcome|Control|standard of care
892199|NCT01115660|O1|Outcome|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
892200|NCT01115660|E2|Reported Event|Control Arm|Patients received standard discharge counseling but no 2-week follow-up call.
892201|NCT01115660|E1|Reported Event|Stroke Education|Patients in this arm receive a telephone call by a medication coach who reviews their condition and importance of adherence to medication regimen.
892202|NCT01115582|B1|Baseline|Cholic Acid|All patients entered and treated
892203|NCT01115582|P1|Participant Flow|Cholic Acid|All patients entered and treated
892204|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
892205|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
892206|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
892207|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
892208|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
892209|NCT01115582|O1|Outcome|Cholic Acid|All patients entered and treated
892210|NCT01115582|E1|Reported Event|Cholic Acid|All patients entered and treated
892211|NCT01115569|B1|Baseline|Open-label Hydrocodone Bitartate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
892212|NCT01115569|P2|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-ER in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
892213|NCT01115569|P1|Participant Flow|Open-label Hydrocodone Bitartrate Extended Release (HC-ER)|Conversion/Titration Phase: HC-ER capsules daily for up to 6 weeks
892214|NCT01115569|O1|Outcome|Open-label Hydrocodone Bitartrate Extended Release Capsules|"Maintenance HC-ER Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
892215|NCT01115569|E2|Reported Event|Maintenance Treatment Phase|"Maintenance Hydrocodone Bitartrate Extended Release (HC-ER) Treatment Phase: Open-label, all patients fulfilling the protocol Inclusion/Exclusion criteria will receive HC-CR in a flexible dosing regimen.~Hydrocodone Bitartrate: Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks"
892216|NCT01115569|E1|Reported Event|Conversion/Titration Phase|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release (HC-ER) capsules daily for up to 6 weeks
892217|NCT01115517|B3|Baseline|Total|Total of all reporting groups
892218|NCT01115517|B2|Baseline|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
892219|NCT01115517|B1|Baseline|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
892220|NCT01115517|P2|Participant Flow|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
892221|NCT01115517|P1|Participant Flow|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
892222|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
892223|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
892224|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
892225|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
892226|NCT01115517|O2|Outcome|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
892227|NCT01115517|O1|Outcome|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
892294|NCT01115166|E1|Reported Event|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
892228|NCT01115517|E2|Reported Event|Mitomycin C|Mitomycin C: Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
917349|NCT01037218|O4|Outcome|Placebo|Placebo tablets
892229|NCT01115517|E1|Reported Event|Bevacizumab|Bevacizumab: 1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
892230|NCT01115491|B1|Baseline|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892231|NCT01115491|P1|Participant Flow|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg per square meter (mg/m^2), orally (PO), on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892232|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892233|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892234|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892235|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892236|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892237|NCT01115491|O1|Outcome|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892238|NCT01115491|E1|Reported Event|Bevacizumab + Temozolomide|"Cycles 1-12 (4-week cycles): Participants received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off); temozolomide 150 mg/m^2, PO, on Days 1 through 7 and on Days 15 through 21 (followed by 1 week off). Cycle was repeated for a maximum of 12 cycles.~Cycle 13 and beyond (4-week cycles): If the first 12 cycles were tolerated with no disease progression, participants then received bevacizumab 10 mg/kg IV on Days 1 and 15 (followed by 2 weeks off). This cycle was repeated every 28 days until disease progression."
892239|NCT01115452|B1|Baseline|Overall Study|
892240|NCT01115452|P1|Participant Flow|5% or 2.5% Potassium Nitrate Solution or Water|Investigator applied the participants with 5% potassium nitrate solution or 2.5% potassium nitrate solution or water to a single sensitive tooth for two minutes (mins), in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892241|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892242|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892243|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892295|NCT01115101|B3|Baseline|Total|Total of all reporting groups
892331|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892244|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892245|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892246|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892247|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892248|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892249|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892250|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892251|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892252|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892253|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892254|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892255|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892256|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892257|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892258|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892259|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892260|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892261|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892262|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892263|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment..
892264|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892265|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892266|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892330|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
895550|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
892332|NCT01114997|E3|Reported Event|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892267|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892268|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892269|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892270|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892271|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892272|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892273|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892274|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892275|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892276|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892277|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892278|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892279|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892280|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892281|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892282|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892283|NCT01115452|O3|Outcome|Water|Investigator applied the participants with sterile water to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892284|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892285|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892286|NCT01115452|O2|Outcome|2.5% Potassium Nitrate Solution|Investigator applied the participants with 2.5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment
892287|NCT01115452|O1|Outcome|5% Potassium Nitrate Solution|Investigator applied the participants with 5% potassium nitrate solution to a single sensitive tooth for two mins, in each of the five day treatment period. This was a split-mouth design where three teeth were treated but each tooth had a different treatment.
892288|NCT01115452|E1|Reported Event|Overall Study|
892289|NCT01115166|B1|Baseline|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
892290|NCT01115166|P1|Participant Flow|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
892291|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
892292|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
892293|NCT01115166|O1|Outcome|Cardiac Surgery|Patients subjected to open cardiac surgery with the help of extracorporal circulation.
892296|NCT01115101|B2|Baseline|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
892297|NCT01115101|B1|Baseline|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
892298|NCT01115101|P2|Participant Flow|Patient Controlled Device With Pritramid|Patients assigned to the Patient-controlled analgesia (PCA) group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
892299|NCT01115101|P1|Participant Flow|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after cesarean section (CS).
892300|NCT01115101|O2|Outcome|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
892301|NCT01115101|O1|Outcome|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
892302|NCT01115101|E2|Reported Event|Patient Controlled Device With Pritramid|Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
892303|NCT01115101|E1|Reported Event|Oxycodon|Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.
892304|NCT01114997|B4|Baseline|Total|Total of all reporting groups
892305|NCT01114997|B3|Baseline|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-Induction (Maintenance Infusion):~Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892306|NCT01114997|B2|Baseline|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892307|NCT01114997|B1|Baseline|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892308|NCT01114997|P3|Participant Flow|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892309|NCT01114997|P2|Participant Flow|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892310|NCT01114997|P1|Participant Flow|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg Post- Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892311|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892312|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892313|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892314|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine (12.5-25 mcg/kg/min) + Esmolol (7.5-15 mcg/kg/min)"
892315|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892316|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892317|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892318|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892319|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892320|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892321|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892322|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892323|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892324|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892325|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892326|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
892327|NCT01114997|O2|Outcome|Esmolol|"Pre-Induction:~Esmolol Loading dose: 750 mcg/Kg (0.75 mg/kg)~Post-Induction:~Infusion dose 7.5 - 15 mcg /kg/min"
892328|NCT01114997|O1|Outcome|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892329|NCT01114997|O3|Outcome|Lidocaine + Esmolol (Combo)|"Pre-induction:~Lidocaine Loading dose(1 mg/kg)+Esmolol Loading dose(750 mcg/Kg)~Post-induction:~Infusion rate: Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
895551|NCT01104584|O1|Outcome|CMRM vs UMRM|
892333|NCT01114997|E2|Reported Event|Esmolol|Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Post-Induction: Infusion dose 7.5 - 15 mcg /kg/min
892334|NCT01114997|E1|Reported Event|Lidocaine|"Pre-Induction:~Lidocaine Loading: 1 mg/kg~Post- Induction:~Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)"
892335|NCT01114945|B5|Baseline|Total|Total of all reporting groups
892336|NCT01114945|B4|Baseline|McGrath|MacGrath device
892337|NCT01114945|B3|Baseline|GlideScope|GlideScope device
892338|NCT01114945|B2|Baseline|Video-Mac|Video-Mac device
892339|NCT01114945|B1|Baseline|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
892340|NCT01114945|P4|Participant Flow|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
892341|NCT01114945|P3|Participant Flow|McGrath|MacGrath
892342|NCT01114945|P2|Participant Flow|GlideScope|GlideScope device
892343|NCT01114945|P1|Participant Flow|Video-Mac|Video-Mac device
892344|NCT01114945|O4|Outcome|McGrath|MacGrath device
892345|NCT01114945|O3|Outcome|GlideScope|GlideScope device
892346|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
892347|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
892348|NCT01114945|O4|Outcome|McGrath|MacGrath device
892349|NCT01114945|O3|Outcome|GlideScope|GlideScope device
892350|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
892351|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscope device
892352|NCT01114945|O4|Outcome|McGrath|MacGrath device
892353|NCT01114945|O3|Outcome|GlideScope|GlideScope device
892354|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
892355|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
892356|NCT01114945|O4|Outcome|McGrath|MacGrath device
892357|NCT01114945|O3|Outcome|GlideScope|GlideScope device
892358|NCT01114945|O2|Outcome|Video-Mac|Video-Mac device
892359|NCT01114945|O1|Outcome|Direct Macintosh Laryngoscopy|Direct Macintosh Laryngoscopy (DL)
892360|NCT01114945|E4|Reported Event|Direct Macintosh Laryngoscopy|"Direct Macintosh Laryngoscopy (DL) used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
892361|NCT01114945|E3|Reported Event|McGrath|"McGrath device used during intubation procedure~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
892362|NCT01114945|E2|Reported Event|GlideScope|"GlideScope device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath~Video-Mac: Video-Mac will be compared with:~Direct Macintosh Laryngoscopy GlideScope and McGrath"
892363|NCT01114945|E1|Reported Event|Video-Mac|"Video-Mac device used during intubation procedure~McGrath: McGrath will be compared with:~Direct Macintosh Laryngoscopy Video-Mac GlideScope~GlideScope: GlideScope will be compared with:~Direct Macintosh Laryngoscopy Video-Mac and McGrath~Direct Macintosh Laryngoscopy: Direct Macintosh Laryngoscopy will be compared with:~GlideScope Video-Mac and McGrath"
892364|NCT01114893|B6|Baseline|Total|Total of all reporting groups
892365|NCT01114893|B5|Baseline|Travoprost Group C|Travoprost Group C
892366|NCT01114893|B4|Baseline|Travoprost Group B|Travoprost Group B
892367|NCT01114893|B3|Baseline|Travoprost Group A|Travoprost Group A
892368|NCT01114893|B2|Baseline|Travoprost Vehicle|Travoprost Vehicle
892369|NCT01114893|B1|Baseline|TRAVATAN|TRAVATAN 0.004% once daily
892370|NCT01114893|P5|Participant Flow|Travoprost Group C|Travoprost Group C
892371|NCT01114893|P4|Participant Flow|Travoprost Group B|Travoprost Group B
892372|NCT01114893|P3|Participant Flow|Travoprost Group A|Travoprost Group A
892373|NCT01114893|P2|Participant Flow|Travoprost Vehicle|Travoprost Vehicle
892374|NCT01114893|P1|Participant Flow|TRAVATAN|TRAVATAN 0.004% once daily
892375|NCT01114893|O5|Outcome|Travoprost Group C|
892376|NCT01114893|O4|Outcome|Travoprost Group B|
892377|NCT01114893|O3|Outcome|Travoprost Group A|
892378|NCT01114893|O2|Outcome|Travoprost Vehicle|
892379|NCT01114893|O1|Outcome|Travatan 0.004% QD|
892380|NCT01114893|O5|Outcome|Travoprost Group C|
892381|NCT01114893|O4|Outcome|Travoprost Group B|
892382|NCT01114893|O3|Outcome|Travoprost Group A|
892383|NCT01114893|O2|Outcome|Travoprost Vehicle|
892384|NCT01114893|O1|Outcome|Travatan 0.004% QD|
892385|NCT01114893|E5|Reported Event|Travoprost Group C|Travoprost Group C
892386|NCT01114893|E4|Reported Event|Travoprost Group B|Travoprost Group B
892387|NCT01114893|E3|Reported Event|Travoprost Group A|Travoprost Group A
892388|NCT01114893|E2|Reported Event|Travoprost Vehicle|Travoprost Vehicle
892389|NCT01114893|E1|Reported Event|TRAVATAN|TRAVATAN 0.004% once daily
892390|NCT01114880|B3|Baseline|Total|Total of all reporting groups
892391|NCT01114880|B2|Baseline|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
892392|NCT01114880|B1|Baseline|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
892393|NCT01114880|P2|Participant Flow|Placebo|Blinded placebo from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
892394|NCT01114880|P1|Participant Flow|Adalimumab|Blinded adalimumab from Week 0 to Week 10, open-label adalimumab from Week 12 to Week 22
892395|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
895552|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
892396|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
893714|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
892397|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892398|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892399|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892400|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892401|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892402|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892403|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892404|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892405|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892406|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892407|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892408|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892409|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892410|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892411|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892412|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892413|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892414|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892415|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892416|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892417|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892418|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892419|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892420|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892421|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892422|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892423|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892424|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892425|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892426|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892427|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892428|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892429|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892430|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892431|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892432|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892433|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892434|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892435|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892436|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892437|NCT01114880|O2|Outcome|Placebo/Adalimumab|Blinded Placebo from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892438|NCT01114880|O1|Outcome|Adalimumab/Adalimumab|Blinded adalimumab from Week 0 to Week 10; open-label adalimumab from Week 12 to Week 22
892439|NCT01114880|E4|Reported Event|Placebo/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded placebo from Week 0 to Week 10
892440|NCT01114880|E3|Reported Event|Adalimumab/Adalimumab (Period 2)|Open-label adalimumab from Week 12 to Week 22 in participants previously on blinded adalimumab from Week 0 to Week 10
892441|NCT01114880|E2|Reported Event|Placebo (Period 1)|Blinded placebo from Week 0 to Week 10
892442|NCT01114880|E1|Reported Event|Adalimumab (Period 1)|Blinded adalimumab from Week 0 to Week 10
892443|NCT01114828|B3|Baseline|Total|Total of all reporting groups
892444|NCT01114828|B2|Baseline|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
892445|NCT01114828|B1|Baseline|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
892446|NCT01114828|P2|Participant Flow|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
892447|NCT01114828|P1|Participant Flow|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
892448|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
892449|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
892450|NCT01114828|O2|Outcome|OPC-41061 7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
892451|NCT01114828|O1|Outcome|OPC-41061 3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
892452|NCT01114828|E2|Reported Event|7.5 mg|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
892453|NCT01114828|E1|Reported Event|3.75 mg|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
892454|NCT01114737|B3|Baseline|Total|Total of all reporting groups
892455|NCT01114737|B2|Baseline|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
892456|NCT01114737|B1|Baseline|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
892457|NCT01114737|P2|Participant Flow|6R-BH4 20 mg/kg/Day|Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact). Patient will be treated for 26 weeks, the first 13 weeks were double-blinded randomized treatment period, the second 13 weeks open label treatment period
892458|NCT01114737|P1|Participant Flow|Placebo|Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study(double-blinded randomized treatment period); then treated with sapropterin dihydrochloride 20 mg/kg/day for an additional 13 weeks (open label treatment period).
892459|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892460|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892461|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892462|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892463|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892464|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892465|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892466|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892467|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892468|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892469|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892470|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892471|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
892472|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
892473|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892474|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892475|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892476|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892477|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892478|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892677|NCT01113931|B1|Baseline|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
892479|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892480|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892481|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892482|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892483|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
892484|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at baseline
892485|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892486|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment.
892487|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892488|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892489|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892490|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892491|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892492|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892493|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892494|NCT01114737|O1|Outcome|Responders in Placebo Arm|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment
892495|NCT01114737|O2|Outcome|Responders in 6R-BH4 20 mg/kg/Day Arm With ADHD Symptoms|Included all subjects in the 6R-BH4 20 mg/kg/day Arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
892496|NCT01114737|O1|Outcome|Responders in Placebo Arm With ADHD Symptoms|Included all subjects in the Placebo arm who had a blood Phe level reduction ≥ 20% from Baseline within their first 4 weeks of sapropterin treatment with ADHD symptoms at Baseline
892497|NCT01114737|E8|Reported Event|6R-BH4 Treatment Period - Combined|6R-BH4 Combined Treatments - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
892498|NCT01114737|E7|Reported Event|6R-BH4 Treatment Period - 6R-BH4|6R-BH4 Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
892499|NCT01114737|E6|Reported Event|Open-Label Treatment Period - Overall|Open-label Treatment Period - All patients
892500|NCT01114737|E5|Reported Event|Open-Label Treatment Period - 6R-BH4|Open-label Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
892501|NCT01114737|E4|Reported Event|Open-Label Treatment Period - Placebo-6R-BH4|Open-label Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
892502|NCT01114737|E3|Reported Event|Randomized Treatment Period - Overall|Randomized Treatment Period - All patients
892503|NCT01114737|E2|Reported Event|Randomized Treatment Period - 6R-BH4|Randomized Treatment Period - Sapropterin dihydrochloride: A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
892504|NCT01114737|E1|Reported Event|Randomized Treatment Period - Placebo|Randomized Treatment Period - Placebo: Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
892505|NCT01114724|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892506|NCT01114724|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892507|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892508|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892509|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892510|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
893711|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
892511|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892512|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892513|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892514|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892515|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892516|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892517|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft will the Captivia Delivery System: All subjects will be implanted with this device
892518|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892519|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892520|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892521|NCT01114724|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System: All subjects will be implanted with this device
892522|NCT01114724|E1|Reported Event|1. Dissection|Medtronic Dissection
892523|NCT01114672|B3|Baseline|Total|Total of all reporting groups
892524|NCT01114672|B2|Baseline|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
892525|NCT01114672|B1|Baseline|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
892526|NCT01114672|P2|Participant Flow|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
892527|NCT01114672|P1|Participant Flow|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
892528|NCT01114672|O2|Outcome|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
892529|NCT01114672|O1|Outcome|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
892530|NCT01114672|E2|Reported Event|Oral Placebo|Patients in the oral placebo Arm/Group received a placebo pill once a week for a period of 12 weeks.
892531|NCT01114672|E1|Reported Event|Ergocalciferol|Patients in the Ergocalciferol Arm/Group received 50,000 international units of oral Ergocalciferol once a week for a study period of 12 weeks.
892532|NCT01114581|B3|Baseline|Total|Total of all reporting groups
892533|NCT01114581|B2|Baseline|Placebo|Given as 2 tablets
892534|NCT01114581|B1|Baseline|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
892535|NCT01114581|P2|Participant Flow|Placebo|Given as 2 tablets
892536|NCT01114581|P1|Participant Flow|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
892537|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
892538|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
892539|NCT01114581|O2|Outcome|Placebo|Given as 2 tablets
892540|NCT01114581|O1|Outcome|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
892541|NCT01114581|E2|Reported Event|Placebo|Given as 2 tablets
892542|NCT01114581|E1|Reported Event|Guaifenesin|Mucinex 1200mg (Guaifenesin)given as 2, 600mg tablets
892543|NCT01114529|B4|Baseline|Total|Total of all reporting groups
892544|NCT01114529|B3|Baseline|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
892545|NCT01114529|B2|Baseline|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
892546|NCT01114529|B1|Baseline|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
892547|NCT01114529|P3|Participant Flow|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
892548|NCT01114529|P2|Participant Flow|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
892549|NCT01114529|P1|Participant Flow|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
892550|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
892551|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
892552|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
892553|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid), and steroids
892554|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
892555|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
895553|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
892556|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
892557|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid), and steroids
892558|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
892559|NCT01114529|O3|Outcome|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid), and steroids
892560|NCT01114529|O2|Outcome|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
892561|NCT01114529|O1|Outcome|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
892562|NCT01114529|E3|Reported Event|Standard CNI (CsA)|Calcineurin inhibitor (CNI) continuation with Cyclosporine (CsA) in combination with Myfortic (mycophenolic acid) and steroids
892563|NCT01114529|E2|Reported Event|Standard CNI (Tac)|Calcineurin inhibitor (CNI) continuation with Tacrolimus (Tac) in combination with Myfortic (mycophenolic acid) and steroids
892564|NCT01114529|E1|Reported Event|Everolimus|Conversion from Calcineurin inhibitor (CNI) to everolimus in combination with Myfortic (mycophenolic acid) and steroids
892565|NCT01114516|B3|Baseline|Total|Total of all reporting groups
892566|NCT01114516|B2|Baseline|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892567|NCT01114516|B1|Baseline|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892568|NCT01114516|P2|Participant Flow|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892569|NCT01114516|P1|Participant Flow|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892570|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892571|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892572|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892573|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892574|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892575|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892576|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892577|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892578|NCT01114516|O2|Outcome|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892579|NCT01114516|O1|Outcome|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892580|NCT01114516|E2|Reported Event|Indomethacin and Antibiotics|"perioperative antibiotics and indomethacin~Indomethacin and antibiotics (cefazolin or clindamycin): q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin"
892581|NCT01114516|E1|Reported Event|Control|emergent cerclage with no peri-operative antibiotics or indomethacin
892582|NCT01114438|B1|Baseline|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
892583|NCT01114438|P1|Participant Flow|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
892584|NCT01114438|O2|Outcome|Device at 6 Months Post-explant|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed.
892585|NCT01114438|O1|Outcome|Device at Month 12 (Explant)|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner was implanted in participants for 12 months and then removed
892586|NCT01114438|O3|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with no change in medication at the time of device removal compared to Baseline medication levels
892587|NCT01114438|O2|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjects implanted with device for 12 Months with an Increase in medication at the time of device removal compared to Baseline medication levels
892588|NCT01114438|O1|Outcome|Decrease in Glucose-Lowering Meds|Subjects implanted with device for 12 Months with an Decrease in medication at the time of device removal compared to Baseline medication levels
892589|NCT01114438|O1|Outcome|EndoBarrier Liner Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
892590|NCT01114438|O1|Outcome|EndoBarrier Liner Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
892591|NCT01114438|E1|Reported Event|Device|EndoBarrier Gastrointestinal Liner: EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 6 months.
892592|NCT01114373|B1|Baseline|All Subjects|African American subjects with mild to moderate essential hypertension received melatonin or placebo PO for the first 4 weeks then were switched to receive either placebo or melatonin PO therapy for an additional 4 weeks without any wash out period in between.
892676|NCT01113931|B2|Baseline|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
892593|NCT01114373|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg daily of time-released melatonin at bed time for 4 weeks, followed by 24 mg of placebo at bed time for 4 week.
892594|NCT01114373|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg of placebo at bed time for 4 weeks followed by 24 mg time release melatonin at bed time for 4 weeks.
892595|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
892596|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
892597|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892598|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
892599|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892600|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
892601|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892602|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892603|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks(either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892604|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892605|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892606|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892607|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892608|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
892609|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892610|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
892611|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892612|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892613|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892614|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892615|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
892616|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892617|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin) .
892618|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
893295|NCT01111123|O1|Outcome|Lac-hydrin + Ultravate|ammonium lactate twice daily everyday + ultravate twice daily weekends only
892619|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892620|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
892621|NCT01114373|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin)
892622|NCT01114373|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892623|NCT01114373|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for 4 weeks (either before or after 4 weeks of exposure to 24mg daily dose of time release melatonin).
892624|NCT01114373|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 24mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892625|NCT01114360|B1|Baseline|All Participants|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
892626|NCT01114360|P2|Participant Flow|Melatonin/Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8 mg of time released melatonin at bed time for 4 weeks, followed by 8 mg of placebo at bedtime for an additional 4 weeks.
892627|NCT01114360|P1|Participant Flow|Placebo/Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of placebo for 4 weeks first, followed by 8 mg of time-released melatonin for 4 weeks.
892628|NCT01114360|O2|Outcome|Placebo|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of treatment with melatonin).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
892629|NCT01114360|O1|Outcome|Melatonin|"African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of treatment with placebo).~Patients were their own controls (cross over design). 40 subjects were randomized to each of the two study arms (total=40). 4 subjects did not complete the study."
892630|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between
892631|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg of time release melatonin or placebo for the first 4 weeks and were then switched to receive either placebo or 8mg of time release melatonin for an additional 4 weeks without any wash out period in between.
892632|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks followed by 8mg time release melatonin for 4 weeks.
892633|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks followed by 4 weeks of placebo.
892634|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after exposure to 8mg time release melatonin for 4 weeks).
892635|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of placebo) in a crossover design.
892636|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8mg time release melatonin).
892637|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892638|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892639|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892640|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks ((either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892641|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892642|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
893594|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
892643|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo)
892644|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892645|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892646|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892647|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892648|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892649|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure placebo).
892650|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks either before or after 4 weeks of exposure to 8mg daily dose of time release melatonin).
892651|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after exposure to 4 weeks of placebo).
892652|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892653|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892654|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892655|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892656|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892657|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892658|NCT01114360|O2|Outcome|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892659|NCT01114360|O1|Outcome|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892660|NCT01114360|E2|Reported Event|Placebo|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received placebo for four weeks (either before or after 4 weeks of exposure to 8 mg daily dose of time release melatonin).
892661|NCT01114360|E1|Reported Event|Melatonin|African American subjects with mild to moderate essential hypertension and an elevated nighttime blood pressure >115 mmHg received 8mg time release melatonin for 4 weeks (either before or after 4 weeks of exposure to placebo).
892662|NCT01114334|B3|Baseline|Total|Total of all reporting groups
892663|NCT01114334|B2|Baseline|Standard Management of Depression|All providers randomized to either intervention or to control received a 1-hour slideshow and the “American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder” (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.
892664|NCT01114334|B1|Baseline|Motivational Interviewing With Guideline-Based Management|"Intervention – MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and “MI Spirit,” as well as skill-building practice. At the providers’ request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service~To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient’s change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
892665|NCT01114334|P2|Participant Flow|Standard Management of Depression|All providers randomized to either intervention or to control received a 1-hour slideshow and the “American Psychiatric Association Practice Guideline for the Treatment of Major Depressive Disorder” (APA depression guideline) (Gelenberg et al., 2010). The resources recommended antidepressant medications and psychotherapy as evidence-based treatments for depression.
893712|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
892666|NCT01114334|P1|Participant Flow|Motivational Interviewing With Guideline-Based Management|"Intervention – MI with Standard Management of Depression The MI training approach included interactive learning for the core MI skills. An 8-hour classroom training on 7/25/09 consisted of a brief overview of MI, videos and discussion of core MI skills and “MI Spirit,” as well as skill-building practice. At the providers’ request, the research team distributed a pocket-sized, laminated treatment outline to MI trained providers for use at the point of service~To optimize treatment integrity, 4-hour refresher sessions were offered after 4 and 12 months on 11/22/09 and 7/11/10. Over the first 14 months, the assistant trainer provided feedback via email and face-to face regarding audio-taped encounters (total two to four feedbacks per provider). In these sessions, the trainer also summarized MI skills demonstrated during the encounters and listed each patient’s change talk statements. Providers were invited to respond and to choose which MI skill(s) they needed to improve."
892667|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
892668|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
892669|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
892670|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
892671|NCT01114334|O2|Outcome|Motivational Interview With GBMM|"Motivational Interviews combined with guideline-based medical management for depression~Guideline-Based Medical Management: We used the Colorado Clinical Guidelines Collaborative treatment guideline for Major Depression. It recommends treatment options e.g. specialty mental health counseling, antidepressant treatment, physical activity, depending upon presenting symptoms severity and other factors. The assessor notifies the clinician at the baseline visit about the patient's PHQ-9 depressive symptom severity score.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or"
892672|NCT01114334|O1|Outcome|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
892673|NCT01114334|E2|Reported Event|Motivational Interview With GBMM|"Motivational Interviewing for Depression combined with guideline-based medical management for depression~Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~Motivational Interviewing for Depression: Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems."
892674|NCT01114334|E1|Reported Event|Guideline-based Medical Management|"Manual-based GBMM training will be provided to both intervention and control physicians. A note on the patient's chart will apprise the primary care provider that the patient screened positive for moderate or more severe depressive symptoms, and has agreed to participate in the study.~The evidence-based algorithm covers medical management of depression including indications for treatment, selection of initial therapy, starting dosages, dose escalation, switching or augmenting treatment, assessing efficacy, treatment goals and duration, a schedule of follow-up visits and referral indications"
892675|NCT01113931|B3|Baseline|Total|Total of all reporting groups
895554|NCT01104584|O1|Outcome|CMRM vs UMRM|
892678|NCT01113931|P2|Participant Flow|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
892679|NCT01113931|P1|Participant Flow|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
892680|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
892681|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
892682|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
892683|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
892684|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
892685|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
892686|NCT01113931|O2|Outcome|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
892687|NCT01113931|O1|Outcome|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
892688|NCT01113931|E2|Reported Event|Vibramycin|Morning: 1 over-encapsulated 100 mg Vibramycin tablet and 1 placebo doxycycline hyclate table, Evening: 1 over-encapsulated 100 mg Vibramycin tablet
892689|NCT01113931|E1|Reported Event|Doxycycline Hyclate|Morning: 1 200 mg tablet doxycycline hyclate and 1 placebo Vibramycin capsule, Evening: 1 placebo Vibramycin capsule
892690|NCT01113749|B3|Baseline|Total|Total of all reporting groups
892691|NCT01113749|B2|Baseline|Control|
892692|NCT01113749|B1|Baseline|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
892693|NCT01113749|P2|Participant Flow|Control|
892694|NCT01113749|P1|Participant Flow|Decision Support|Structured decision aid with prompting to share information in discussion with primary treating health care providers.
892695|NCT01113749|O2|Outcome|Control|Usual care
892696|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
892697|NCT01113749|O2|Outcome|Control|Usual care
892698|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
892699|NCT01113749|O2|Outcome|Control|Usual care
892700|NCT01113749|O1|Outcome|Decision Support Intervention|Decision aid
892701|NCT01113749|E2|Reported Event|Control|
892702|NCT01113749|E1|Reported Event|Decisions Support Intervention|
892703|NCT01113723|B3|Baseline|Total|Total of all reporting groups
892704|NCT01113723|B2|Baseline|Fiberoptic Bronchoscope|"Fiberoptic bronchoscope~Fiberoptic bronchoscope: Fiberoptic bronchoscope device"
892705|NCT01113723|B1|Baseline|CMAC Device|"CMAC~CMAC: CMAC Device"
892706|NCT01113723|P2|Participant Flow|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
892707|NCT01113723|P1|Participant Flow|CMAC Device|"CMAC~CMAC: CMAC Device"
892708|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
892709|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
892710|NCT01113723|O2|Outcome|Fiberoptic Bronchoscope|Fiberoptic bronchoscope device: the flexible fiberoptic scope (FFS)
892711|NCT01113723|O1|Outcome|CMAC Device|"CMAC~CMAC: CMAC Device"
892712|NCT01113723|O2|Outcome|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
892713|NCT01113723|O1|Outcome|CMAC Device|CMAC: CMAC Device
892714|NCT01113723|E2|Reported Event|Flexible Fiberoptic Scope (FFS)|the flexible fiberoptic scope (FFS) the flexible fiberoptic scope (FFS) : the flexible fiberoptic scope (FFS)
892715|NCT01113723|E1|Reported Event|CMAC Device|"CMAC~CMAC: CMAC Device"
892716|NCT01113710|B1|Baseline|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892717|NCT01113710|P1|Participant Flow|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892718|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892719|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892720|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892721|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892722|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892723|NCT01113710|O1|Outcome|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892724|NCT01113710|E1|Reported Event|Neupro®|Routine treatment in accordance with the local marketing authorization for Neupro® in RLS
892725|NCT01113632|B3|Baseline|Total|Total of all reporting groups
892726|NCT01113632|B2|Baseline|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892778|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
895555|NCT01104584|O5|Outcome|CMRM+XRM|
893296|NCT01111123|O2|Outcome|Ammoium Lactate + Placebo|ammonium lactate twice daily everyday plus placebo ointment twice daily weekends only
892727|NCT01113632|B1|Baseline|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892728|NCT01113632|P2|Participant Flow|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892729|NCT01113632|P1|Participant Flow|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892730|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892731|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
892732|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892733|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
892734|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892735|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
892736|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892737|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
892738|NCT01113632|O2|Outcome|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892779|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892739|NCT01113632|O1|Outcome|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 1000 mg."
892740|NCT01113632|E2|Reported Event|Ofatumumab 2000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 2000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892741|NCT01113632|E1|Reported Event|Ofatumumab 1000mg|"Ofatumumab 300mg IV Day 1 followed by ofatumumab 1000mg weekly for a total of 8 weeks~Ofatumumab: IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg."
892742|NCT01113580|B3|Baseline|Total|Total of all reporting groups
892743|NCT01113580|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
892744|NCT01113580|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
892745|NCT01113580|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
892746|NCT01113580|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
892747|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
892748|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
892749|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
892750|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
892751|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
892752|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
892753|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
892754|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
892755|NCT01113580|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
892756|NCT01113580|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
892757|NCT01113580|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
892758|NCT01113580|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
892759|NCT01113541|B1|Baseline|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892760|NCT01113541|P1|Participant Flow|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892761|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892762|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892763|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892764|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892765|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892766|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892767|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892768|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892769|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892770|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892771|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892772|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892773|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892774|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892775|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892776|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892777|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
895556|NCT01104584|O4|Outcome|UMRM+XRM|
892780|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892781|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892782|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892783|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892784|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892785|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892786|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892787|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892788|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892789|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892790|NCT01113541|O1|Outcome|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892791|NCT01113541|E1|Reported Event|Ziprasidone|Days 1 to 3: 40 milligrams (mg) twice daily (BID); Days 4 to 7: 60 mg BID; Days 8 to15: 80 mg BID; Day 16 to Week 52: 20-80 mg BID flexible dosing.
892792|NCT01113463|B1|Baseline|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
892793|NCT01113463|P1|Participant Flow|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
892794|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
892795|NCT01113463|O1|Outcome|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
892796|NCT01113463|E1|Reported Event|TPI 287|TPI 287: Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
892797|NCT01113398|B1|Baseline|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
892798|NCT01113398|P1|Participant Flow|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
892799|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
892800|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
892801|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
892802|NCT01113398|O1|Outcome|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
892826|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
892827|NCT01112917|E1|Reported Event|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
892803|NCT01113398|E1|Reported Event|AMG 102 With Avastin|"Avastin will be administered as a continuous intravenous infusion at 10 mg/kg prior to AMG 102, which will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg. Subjects will receive infusions every 2 weeks.~AMG 102: AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.~Avastin: Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102."
892804|NCT01113385|B1|Baseline|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
892805|NCT01113385|P1|Participant Flow|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
892806|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
892807|NCT01113385|O1|Outcome|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
892808|NCT01113385|E1|Reported Event|Galactose|"Oral galactose will be given at a dose of 0.2gm/kg/dose twice a day (BID) to a maximum of 15 gm BID for a period of 16 weeks.~D-Galactose: Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally."
892809|NCT01113008|B3|Baseline|Total|Total of all reporting groups
892810|NCT01113008|B2|Baseline|Control Group|Control group: In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
892811|NCT01113008|B1|Baseline|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning: Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
892812|NCT01113008|P2|Participant Flow|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
892813|NCT01113008|P1|Participant Flow|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
892814|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
892815|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
892816|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
892817|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
892818|NCT01113008|O2|Outcome|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
892819|NCT01113008|O1|Outcome|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
892820|NCT01113008|E2|Reported Event|Remote Postcondtioning|"Patients assigned to remote ischemic postconditioning (randomized controlled trial)~Remote ischemic postconditioning : Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated"
892821|NCT01113008|E1|Reported Event|Control Group|Control group : In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
892822|NCT01112917|B1|Baseline|VenaTech Convertible Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
892823|NCT01112917|P2|Participant Flow|VenaTech Convertible Filter - Permanent Filtration|VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism
892824|NCT01112917|P1|Participant Flow|VenaTech Convertible Filter - Converted Filter|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
892825|NCT01112917|O1|Outcome|VenaTech Convertible Filter - Converted Filters|"VenaTech Convertible Vena Cava Filter: Prevention of Pulmonary Embolism~Vena Cava Filter Conversion: Conversion of VenaTech Convertible filter to open configuration."
892828|NCT01112865|B1|Baseline|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892829|NCT01112865|P2|Participant Flow|Genotropin® Pen Then Mark VII Pen|Participant (not caregiver) used current Genotropin® pen (subcutaneous injections daily for 2 months) then the Mark VII pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892830|NCT01112865|P1|Participant Flow|Mark VII Pen Then Genotropin® Pen|Participant (not caregiver) used Mark VII pen (subcutaneous injections daily for 2 months) then the current Genotropin® pen (subcutaneous injections daily for 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
892831|NCT01112865|O2|Outcome|Genotropin® Pen|Participants who used the current Genotropin® pen (subcutaneous injections daily for 2 months) anytime during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892832|NCT01112865|O1|Outcome|Mark VII Pen|Participants who used the Mark VII pen (subcutaneous injections daily for 2 months) any time during the study. Pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin recombinant deoxyribonucleic acid [rDNA] origin); doses received by participants based on body weight.
892833|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892834|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892835|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892836|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892837|NCT01112865|O1|Outcome|Entire Study Population|Includes participants randomized to first use the Mark VII pen (subcutaneous injections daily for 2 months) and participants randomized to first use the current Genotropin® pen (subcutaneous injections daily 2 months). Both pens provided in 5, 5.3, and 12 mg doses of Genotropin (somatropin [rDNA origin]); doses received by participants based on body weight.
892838|NCT01112865|E1|Reported Event|Safety Population|All randomized participants who used a study pen (Genotropin® pen or the new Mark VII injection pen) at least once to administer Genotropin.
892839|NCT01112696|B1|Baseline|Group 1|Sensor Users (All Subjects)
892840|NCT01112696|P1|Participant Flow|Group 1|Sensor Users (All Subjects)
892841|NCT01112696|O1|Outcome|All Completed Subjects|All subjects that completed the frequent blood sampling procedure
892842|NCT01112696|E1|Reported Event|Group 1|Sensor Users (All Subjects)
892843|NCT01112683|B3|Baseline|Total|Total of all reporting groups
892844|NCT01112683|B2|Baseline|Placebo|These are identically-looking pills to the ones in the Memantine Arm
892845|NCT01112683|B1|Baseline|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
892846|NCT01112683|P2|Participant Flow|Placebo|These are identically-looking pills to the ones in the Memantine Arm
892847|NCT01112683|P1|Participant Flow|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
892848|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
892849|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
892850|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
892851|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
892852|NCT01112683|O2|Outcome|Placebo|These are identically-looking pills to the ones in the Memantine Arm
892853|NCT01112683|O1|Outcome|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
892854|NCT01112683|E2|Reported Event|Placebo|These are identically-looking pills to the ones in the Memantine Arm
892855|NCT01112683|E1|Reported Event|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
892856|NCT01112670|B1|Baseline|Overall Study Population|All participants who participated in at least one period of the study (n=33)
892857|NCT01112670|P6|Participant Flow|ABCB1 Group 3*|ABCB1 TTT/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 5 participants started. 5 participants completed.
892858|NCT01112670|P5|Participant Flow|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 6 participants started. 5 participants completed.
892859|NCT01112670|P4|Participant Flow|ABCB1 Group 2*|ABCB1 CGC/TTT genetic make-up. Sitagliptin+Atorvastatin to Sitagiptin. 4 participants started. 4 participants completed.
895557|NCT01104584|O3|Outcome|X-ray Mammography (XRM)|
892860|NCT01112670|P3|Participant Flow|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 7 participants started. 6 participants completed.
892861|NCT01112670|P2|Participant Flow|ABCB1 Group 1*|ABCB1 CGC/CGC genetic make-up. Sitagliptin+Atorvastatin to Sitagliptin. 3 participants started. 3 participants completed.
892862|NCT01112670|P1|Participant Flow|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up. Sitagliptin to Sitagliptin+Atorvastatin. 8 participants started. 7 participants completed.
892863|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892864|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892865|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892866|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892867|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892868|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892869|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892870|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892871|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892872|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892873|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892874|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892875|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892876|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892877|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892878|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892879|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892880|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892881|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892882|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892883|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892884|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892885|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/CGC genetic make-up
892886|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892887|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892888|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892889|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892890|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892891|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892892|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892893|NCT01112670|O3|Outcome|ABCB1 Group 3|ABCB1 TTT/TTT genetic make-up
892894|NCT01112670|O2|Outcome|ABCB1 Group 2|ABCB1 CGC/TTT genetic make-up
892895|NCT01112670|O1|Outcome|ABCB1 Group 1|ABCB1 CGC/CGC genetic make-up
892896|NCT01112670|E1|Reported Event|Overall Study Population|All participants who started the study (n=33)
892897|NCT01112579|B3|Baseline|Total|Total of all reporting groups
892898|NCT01112579|B2|Baseline|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
892899|NCT01112579|B1|Baseline|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
892900|NCT01112579|P2|Participant Flow|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
892901|NCT01112579|P1|Participant Flow|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
892902|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
892903|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
892904|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
892905|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
892906|NCT01112579|O2|Outcome|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
892907|NCT01112579|O1|Outcome|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
892908|NCT01112579|E2|Reported Event|Control|Medtronic PrimeADVANCED Neurostimulator: Medical management
892909|NCT01112579|E1|Reported Event|Treatment|Medtronic PrimeADVANCED Neurostimulator: Heart failure therapy
892910|NCT01112514|B1|Baseline|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
892911|NCT01112514|P1|Participant Flow|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
892912|NCT01112514|O1|Outcome|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
892913|NCT01112514|E1|Reported Event|ICG Injection|Participants received an Indocyanine Green Fluorescent (ICG) injection in order to study imaging of the colon during a colonoscopy.
892914|NCT01112267|B3|Baseline|Total|Total of all reporting groups
892915|NCT01112267|B2|Baseline|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892916|NCT01112267|B1|Baseline|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892917|NCT01112267|P2|Participant Flow|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892918|NCT01112267|P1|Participant Flow|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
893595|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
892919|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892920|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892921|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892922|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892923|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892924|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892925|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892926|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892927|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892928|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892929|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892930|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892931|NCT01112267|O2|Outcome|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892932|NCT01112267|O1|Outcome|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892933|NCT01112267|E2|Reported Event|Placebo|Participants received 1 tablet of matching placebo once daily orally on Days 1 to 3, 1 tablet twice daily on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892934|NCT01112267|E1|Reported Event|Tramadol HCl/Acetaminophen|Participants received 1 tablet containing fixed dose of combination of tramadol hydrochloride (HCl) 75 milligram (mg) /acetaminophen Extended Release (ER) 650 mg orally once daily on Days 1 to 3, 1 tablet twice daily (tramadol HCl 150 mg/acetaminophen 1300 mg) on Days 4 to 7, then 1 or 2 tablets twice daily on Days 8 to 28.
892935|NCT01112241|B1|Baseline|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892936|NCT01112241|P1|Participant Flow|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892937|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892938|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892939|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
893049|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
892940|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892941|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892942|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892943|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892944|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892945|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892946|NCT01112241|O1|Outcome|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892947|NCT01112241|E1|Reported Event|Albuterol Plus Tiotropium|At visit 1, lung function measurements will be performed in triplicate before and 90 min after inhaling four separate doses of 100 μg of albuterol (Ventolin®) and soon after 18 μg of tiotropium bromide [Spiriva®] to ensure maximal or near-maximal bronchodilation. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber (Volumatic®) and tiotropium by a dry-powder device (Handihaler®).
892948|NCT01112059|B3|Baseline|Total|Total of all reporting groups
892949|NCT01112059|B2|Baseline|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
892950|NCT01112059|B1|Baseline|Placebo|placebo: placebo
892951|NCT01112059|P2|Participant Flow|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
892952|NCT01112059|P1|Participant Flow|Placebo|placebo: placebo
892953|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
892954|NCT01112059|O1|Outcome|Placebo|placebo for 8 days
892955|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
892956|NCT01112059|O1|Outcome|Placebo|placebo for 8 days
892957|NCT01112059|O2|Outcome|Placebo|placebo for 8 days
892958|NCT01112059|O1|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
892959|NCT01112059|O2|Outcome|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
892960|NCT01112059|O1|Outcome|Placebo|"placebo: placebo~No SAEs noted in this group, 4 total AEs recorded."
892961|NCT01112059|E2|Reported Event|Doxycycline|Doxycycline: 100 mg twice a day for 8 days
892962|NCT01112059|E1|Reported Event|Placebo|placebo: placebo
892963|NCT01111851|B3|Baseline|Total|Total of all reporting groups
892964|NCT01111851|B2|Baseline|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
892965|NCT01111851|B1|Baseline|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
892966|NCT01111851|P2|Participant Flow|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
892967|NCT01111851|P1|Participant Flow|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
892968|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
892969|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
892970|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
892971|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
892972|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
892973|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
892974|NCT01111851|O2|Outcome|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
892975|NCT01111851|O1|Outcome|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
892976|NCT01111851|E2|Reported Event|Aprepitant 165 mg|A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.
892977|NCT01111851|E1|Reported Event|Fosaprepitant 150 mg|A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.
892978|NCT01111838|B1|Baseline|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
892979|NCT01111838|P1|Participant Flow|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
892980|NCT01111838|O1|Outcome|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
892981|NCT01111838|E1|Reported Event|Patients With Refractory Metastatic Colorectal Cancer|Clinical and Translational Study of STA-9090 in Patients with Refractory Metastatic Colorectal Cancer
892982|NCT01111526|B1|Baseline|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892983|NCT01111526|P3|Participant Flow|Phase II Participants Treated at MTD|All participants enrolled during Phase II.
892984|NCT01111526|P2|Participant Flow|Phase I Participants Evaluable for MTD|Participants treated after the formulation change.
892985|NCT01111526|P1|Participant Flow|Phase I Participants Not Evaluable for MTD|Participants who began treatment before the formulation change.
892986|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892987|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892988|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892989|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892990|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892991|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892992|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892993|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892994|NCT01111526|O1|Outcome|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892995|NCT01111526|E1|Reported Event|LBH589, in Addition to Glucocorticoids|Phase I Dose Escalation, Followed by Phase II Treatment at Maximum Tolerated Dose (MTD) of LBH589, in Addition to Glucocorticoids.
892996|NCT01111461|B1|Baseline|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
892997|NCT01111461|P1|Participant Flow|Lenvatinib 24 mg|Lenvatinib hard capsules, 24 mg (two 10-mg capsules and one 4-mg capsule) were self-administered orally once a day in the morning (without regard to food intake) in 28-day cycles. Dose reduction or interruption was allowed for participants who experienced lenvatinib-related toxicity.
892998|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
892999|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893000|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893001|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893002|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893003|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893004|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893005|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893006|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893007|NCT01111461|O1|Outcome|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893008|NCT01111461|E1|Reported Event|Lenvatinib 24 mg|Lenvatinib 24 mg was administered orally, once daily continuously in 28-day cycles
893009|NCT01111370|B1|Baseline|Continuous Glucose Monitoring System|The Dexcom G4 Continuous Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
893010|NCT01111370|P1|Participant Flow|Continuous Glucose Monitoring System|DexCom™ G4 Continuous Glucose Monitoring System : Continuous Glucose Monitoring System, that is a glucose monitoring device indicated for detecting trends and tracking patterns in persons with diabetes. The system is intended for single patient use and requires a prescription.
893011|NCT01111370|O1|Outcome|CGM Device|DexCom™ G4 Continuous Glucose Monitoring System
893012|NCT01111370|E1|Reported Event|Real Time Continuous Glucose Monitoring System|"continuous glucose monitoring system~DexCom™ G4 Continuous Glucose Monitoring System: Continuous Glucose Monitoring System"
893050|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893013|NCT01111331|B1|Baseline|Study Overall|"Total number of patients randomised and treated in the study. This was a randomised, cross-over, open-label trial consisting of three treatments. 18 patients were randomised to one of two possible treatment sequences. The three treatments were~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1"
893014|NCT01111331|P2|Participant Flow|Warfarin / Empa / Empa Plus Warfarin|"Patients received three treatments in the following order~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~There was a washout period of at least 14 days between the first and second treatment periods."
893015|NCT01111331|P1|Participant Flow|Empa / Empa Plus Warfarin / Warfarin|"Patients received three treatments in the following order~Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5~Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1~Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1~There was a washout period of at least 14 days between the second and third treatment periods."
893016|NCT01111331|O3|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893017|NCT01111331|O2|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893018|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893019|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893020|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893021|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893022|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893023|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893024|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893025|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893026|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893027|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893028|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893029|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893030|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893031|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893032|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893033|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893034|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893035|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893036|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893037|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893038|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893039|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893040|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893041|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893042|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893043|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893044|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893045|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893046|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893047|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893048|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893051|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893052|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893053|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893054|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893055|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893056|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893057|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893058|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893059|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893060|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893061|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893062|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893063|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893064|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893065|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893066|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893067|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893068|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893069|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893070|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893071|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893072|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893073|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893074|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893075|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893076|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893077|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893078|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893079|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893080|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893081|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893082|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893083|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893084|NCT01111331|O1|Outcome|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893085|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893086|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893087|NCT01111331|O2|Outcome|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893088|NCT01111331|O1|Outcome|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893089|NCT01111331|E3|Reported Event|Empa Plus Warfarin|Empagliflozin (empa) 25mg was given once daily on Days 1 to 7 and warfarin 25mg, consisting of 5 tablets of 5mg, was given as a single dose on Day 1
893090|NCT01111331|E2|Reported Event|Warfarin|Warfarin 25mg was given as a single dose, consisting of 5 individual tablets, on Day 1
893091|NCT01111331|E1|Reported Event|Empa|Empagliflozin (empa) 25mg given once daily, consisting of a single tablet, on Days 1 to 5
893092|NCT01111318|B5|Baseline|Total|Total of all reporting groups
893293|NCT01111123|P1|Participant Flow|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
893093|NCT01111318|B4|Baseline|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893094|NCT01111318|B3|Baseline|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893095|NCT01111318|B2|Baseline|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893096|NCT01111318|B1|Baseline|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893097|NCT01111318|P4|Participant Flow|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893098|NCT01111318|P3|Participant Flow|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893099|NCT01111318|P2|Participant Flow|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893100|NCT01111318|P1|Participant Flow|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893101|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893102|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893103|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893104|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893105|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893106|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893107|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893108|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893109|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893110|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893111|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893112|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893113|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893114|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893115|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893116|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893117|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893118|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893119|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893120|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893121|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893122|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893123|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893124|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
895558|NCT01104584|O2|Outcome|CMRM|
893125|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893126|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893127|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893128|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893129|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893130|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893131|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893132|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893133|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893134|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893135|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893136|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893137|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893138|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893139|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893140|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893141|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893142|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893143|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893144|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893145|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893146|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893147|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893148|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893149|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893150|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893151|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893152|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893153|NCT01111318|O4|Outcome|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893154|NCT01111318|O3|Outcome|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893155|NCT01111318|O2|Outcome|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893156|NCT01111318|O1|Outcome|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
895559|NCT01104584|O1|Outcome|UMRM|
893157|NCT01111318|E4|Reported Event|Severe|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with severe liver impairment defined by Child-Pugh class C.
893158|NCT01111318|E3|Reported Event|Moderate|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with moderate liver impairment defined by Child-Pugh class B.
893159|NCT01111318|E2|Reported Event|Mild|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for patients with mild liver impairment defined by Child-Pugh class A.
893160|NCT01111318|E1|Reported Event|Healthy|Single oral dose of empagliflozin (empa) 50mg (2 tablets of 25mg) following an overnight fast, for healthy subjects with normal liver function who matched the hepatically impaired subjects with regard to age and weight.
893161|NCT01111305|B3|Baseline|Total|Total of all reporting groups
893162|NCT01111305|B2|Baseline|Placebo|"Placebo~Diethylcarbamazine"
893163|NCT01111305|B1|Baseline|Reslizumab|"Reslizumab~Diethylcarbamazine"
893164|NCT01111305|P2|Participant Flow|Placebo|"Placebo~Diethylcarbamazine"
893165|NCT01111305|P1|Participant Flow|Reslizumab|"Reslizumab~Diethylcarbamazine"
893166|NCT01111305|O2|Outcome|Placebo|"Placebo~Diethylcarbamazine"
893167|NCT01111305|O1|Outcome|Reslizumab|"Reslizumab~Diethylcarbamazine"
893168|NCT01111305|O2|Outcome|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
893169|NCT01111305|O1|Outcome|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
893170|NCT01111305|O2|Outcome|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
893171|NCT01111305|O1|Outcome|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
893172|NCT01111305|E2|Reported Event|Placebo + DEC|"Placebo iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Diethylcarbamazine~Placebo"
893173|NCT01111305|E1|Reported Event|Reslizumab + DEC|"Reslizumab 1 mg/kg iv single dose followed by diethylcarbamazine 9 mg/kg/day po for 21 days~Reslizumab~Diethylcarbamazine"
893174|NCT01111292|B3|Baseline|Total|Total of all reporting groups
893175|NCT01111292|B2|Baseline|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893176|NCT01111292|B1|Baseline|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893177|NCT01111292|P2|Participant Flow|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893178|NCT01111292|P1|Participant Flow|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893179|NCT01111292|O2|Outcome|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893180|NCT01111292|O1|Outcome|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893181|NCT01111292|E2|Reported Event|Arm II (Placebo)|"Beginning within 14 days after colonoscopy, patients receive placebo PO QD on days 1-14 and BID on days 15-90.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893182|NCT01111292|E1|Reported Event|Arm I (Inositol)|"Beginning within 14 days after colonoscopy, patients receive inositol PO QD on days 1-14 and BID on days 15-90.~Inositol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
893183|NCT01111240|B1|Baseline|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893184|NCT01111240|P1|Participant Flow|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893185|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893186|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893187|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893188|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893189|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893190|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893191|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893192|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893193|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893194|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893195|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
895560|NCT01104584|O4|Outcome|UMRM+XRM|
893196|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893197|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893198|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893199|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893200|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893201|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893202|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893203|NCT01111240|O1|Outcome|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893204|NCT01111240|E1|Reported Event|Psoriatic Arthritis|Participants with Psoriatic Arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 24 months.
893205|NCT01111162|B1|Baseline|Vaccination Group (Single Arm Study)|All participants
893206|NCT01111162|P1|Participant Flow|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
893207|NCT01111162|O1|Outcome|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
893208|NCT01111162|O1|Outcome|Vacinees|
893209|NCT01111162|E1|Reported Event|Vaccine Arm (Single Arm)|15 µg dose of the monovalent, unadjuvanted, inactivated, split virus H1N1 vaccine (Novartis, Basel, Switzerland).
893210|NCT01111149|B4|Baseline|Total|Total of all reporting groups
893211|NCT01111149|B3|Baseline|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893212|NCT01111149|B2|Baseline|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893213|NCT01111149|B1|Baseline|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893214|NCT01111149|P3|Participant Flow|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893215|NCT01111149|P2|Participant Flow|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893216|NCT01111149|P1|Participant Flow|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893217|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893218|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893219|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893220|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893255|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
895561|NCT01104584|O3|Outcome|CMRM+XRM|
893221|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893222|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893223|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893224|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893225|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893226|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893227|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893228|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893229|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893230|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893231|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893232|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893233|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893234|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893235|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893236|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893237|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893294|NCT01111123|O2|Outcome|Lac-hydrin + Placebo|lac hydrin twice daily everyday plus placebo ointment twice daily weekends only
893238|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893239|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893240|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893241|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893242|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893243|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893244|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893245|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893246|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893247|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893248|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893249|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893250|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893251|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893252|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893253|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893254|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893256|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893257|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893258|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893259|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893260|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893261|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893262|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893263|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893264|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893265|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893266|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893267|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893268|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893269|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893270|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893271|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893272|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893273|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893274|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893275|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893276|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893277|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893278|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893279|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893280|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893281|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893282|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893283|NCT01111149|O3|Outcome|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893284|NCT01111149|O2|Outcome|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893285|NCT01111149|O1|Outcome|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893286|NCT01111149|E3|Reported Event|Bupropion HCl|"Bupropion HCl is an established smoking cessation agent and will be used to compare its efficacy and safety against varenicline. Subjects in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study.~Bupropion HCl: in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study"
893287|NCT01111149|E2|Reported Event|Varenicline|"Varenicline has not previously been examined for its efficacy and safety in subjects with schizophrenia. Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study. This is an experimental group to be compared against both placebo and bupropion HCl.~Varenicline: Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study."
893288|NCT01111149|E1|Reported Event|Sugar Pill|"Sugar pill will be given to patients as a comparison group to the active varenicline group. In the fist week, one placebo pill will be given per patient, followed by 2 pills per day for the remaining 12 weeks of the study.~Sugar Pill: Sugar pill created and masked by the pharmacy to be used as a control."
893289|NCT01111123|B3|Baseline|Total|Total of all reporting groups
893290|NCT01111123|B2|Baseline|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
893291|NCT01111123|B1|Baseline|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
893292|NCT01111123|P2|Participant Flow|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
893297|NCT01111123|O1|Outcome|Ammonium Lactate + Ultravate|ammonium lactate twice daily everyday plus ultravte ointment twice daily on weekends only for up to 24 weeks
893298|NCT01111123|E2|Reported Event|Lac Hydrin + Placebo|Lac-Hydrin lotion twice daily everyday + placebo ointment twice daily on weekends only, for up to 24 weeks
893299|NCT01111123|E1|Reported Event|Lac-hydrin + Ultravate|Lac-Hydrin lotion twice daily everyday + Ultravate ointment twice daily on weekends only, for up to 24 weeks
893300|NCT01111110|B3|Baseline|Total|Total of all reporting groups
893301|NCT01111110|B2|Baseline|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
893302|NCT01111110|B1|Baseline|Anti-static/Static|albuterol with anti-static chamber then Static on another night
893303|NCT01111110|P2|Participant Flow|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
893304|NCT01111110|P1|Participant Flow|Anti-static/Static|albuterol with anti-static chamber then Static on another night
893305|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
893306|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
893307|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
893308|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
893309|NCT01111110|O2|Outcome|Static/Antistatic|albuterol with static chamber then with antistatic chamber on another night.
893310|NCT01111110|O1|Outcome|Anti-static/Static|albuterol with anti-static chamber then Static on another night
893311|NCT01111110|E2|Reported Event|Antistatic|albuterol with antistatic chamber.
893312|NCT01111110|E1|Reported Event|Static|albuterol with static chamber
893313|NCT01110967|B1|Baseline|Patients Implanted With a Satellite Device|
893314|NCT01110967|P1|Participant Flow|Patients Implanted With a Satellite Device|
893315|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893316|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893317|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893318|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893319|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893320|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893321|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893322|NCT01110967|O1|Outcome|Patients Implanted With a Satellite Device|
893323|NCT01110967|E1|Reported Event|Patients Implanted With a Satellite Device|
893324|NCT01110915|B3|Baseline|Total|Total of all reporting groups
893325|NCT01110915|B2|Baseline|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
893326|NCT01110915|B1|Baseline|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893327|NCT01110915|P2|Participant Flow|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
893328|NCT01110915|P1|Participant Flow|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893329|NCT01110915|O1|Outcome|Implanted Subjects|Any subject who underwent a successful implant of the Advisa MRI system.
893330|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893331|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
893332|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893333|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
893334|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893335|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
893336|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893337|NCT01110915|O2|Outcome|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
893338|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893339|NCT01110915|O1|Outcome|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893340|NCT01110915|E2|Reported Event|Control Group|Subjects randomized to the Control group waited for one hour without having any MRI scan at 9-12 weeks post-implant.
893341|NCT01110915|E1|Reported Event|MRI Group|Subjects randomized to the MRI group underwent a one-hour MRI scan, including 16 individual sequences in the chest and head region, at 9-12 weeks post-implant.
893342|NCT01110499|B9|Baseline|Total|Total of all reporting groups
893343|NCT01110499|B8|Baseline|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
893344|NCT01110499|B7|Baseline|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
893345|NCT01110499|B6|Baseline|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
895562|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
893597|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893346|NCT01110499|B5|Baseline|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893347|NCT01110499|B4|Baseline|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893348|NCT01110499|B3|Baseline|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893349|NCT01110499|B2|Baseline|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893350|NCT01110499|B1|Baseline|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893351|NCT01110499|P8|Participant Flow|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
893352|NCT01110499|P7|Participant Flow|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
893353|NCT01110499|P6|Participant Flow|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893354|NCT01110499|P5|Participant Flow|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893355|NCT01110499|P4|Participant Flow|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893356|NCT01110499|P3|Participant Flow|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893357|NCT01110499|P2|Participant Flow|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893358|NCT01110499|P1|Participant Flow|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893359|NCT01110499|O2|Outcome|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
893360|NCT01110499|O1|Outcome|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
893361|NCT01110499|O7|Outcome|Part 1, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in the other eye in all Part 1 treatment groups once daily for 7 days.
893362|NCT01110499|O6|Outcome|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye once daily for 7 days.
893363|NCT01110499|O5|Outcome|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye once daily for 7 days.
893364|NCT01110499|O4|Outcome|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye once daily for 7 days.
893365|NCT01110499|O3|Outcome|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye once daily for 7 days.
893366|NCT01110499|O2|Outcome|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye once daily for 7 days.
893367|NCT01110499|O1|Outcome|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye once daily for 7 days.
893368|NCT01110499|E9|Reported Event|Part 2, Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03% in both eyes once daily for 4 weeks.
893369|NCT01110499|E8|Reported Event|Part 2, AGN-210961 Formulation 7|AGN-210961 Formulation 7 (a different formulation from those used in Part 1) in both eyes once daily for 4 weeks.
893370|NCT01110499|E7|Reported Event|Part 1, Bimatoprost Ophthalmic Solution 0.03% Treated Eye|bimatoprost ophthalmic solution 0.03% in the non-study eye once daily for 7 days (all bimatoprost ophthalmic solution 0.03% treated eyes in Part 1 combined).
893371|NCT01110499|E6|Reported Event|Part 1, AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893372|NCT01110499|E5|Reported Event|Part 1, AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893373|NCT01110499|E4|Reported Event|Part 1, AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893374|NCT01110499|E3|Reported Event|Part 1, AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893375|NCT01110499|E2|Reported Event|Part 1, AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893376|NCT01110499|E1|Reported Event|Part 1, AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye and bimatoprost ophthalmic solution 0.03% in the other eye once daily for 7 days.
893377|NCT01110421|B3|Baseline|Total|Total of all reporting groups
893378|NCT01110421|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893379|NCT01110421|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893380|NCT01110421|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893381|NCT01110421|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893382|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
895563|NCT01104584|O1|Outcome|UMRM|
893383|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893384|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893385|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893386|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893387|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893388|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893389|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893390|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893391|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893392|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893393|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893394|NCT01110421|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893395|NCT01110421|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893396|NCT01110421|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893397|NCT01110421|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893398|NCT01110408|B3|Baseline|Total|Total of all reporting groups
893399|NCT01110408|B2|Baseline|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893400|NCT01110408|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893401|NCT01110408|P2|Participant Flow|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893402|NCT01110408|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893403|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893404|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893405|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893406|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893407|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
895564|NCT01104584|O4|Outcome|UMRM+XRM|
893408|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893409|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893410|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893411|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893412|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893413|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893414|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893415|NCT01110408|O2|Outcome|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893416|NCT01110408|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893417|NCT01110408|E2|Reported Event|Cefepime|Cefepime 50 mg/kg per dose (up to 2 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893418|NCT01110408|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
893419|NCT01110382|B3|Baseline|Total|Total of all reporting groups
893420|NCT01110382|B2|Baseline|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893421|NCT01110382|B1|Baseline|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893422|NCT01110382|P2|Participant Flow|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893423|NCT01110382|P1|Participant Flow|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893424|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893425|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893426|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893427|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893428|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893429|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893430|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893431|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893432|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893481|NCT01110239|O1|Outcome|Sham Preconditioning|Limb preconditioning intervention at increasing durations of ischemia: 5, 7.5 and 10 min.
893482|NCT01110239|O4|Outcome|10 Min Ischemia|
893433|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893434|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893435|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893436|NCT01110382|O2|Outcome|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893437|NCT01110382|O1|Outcome|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893438|NCT01110382|E2|Reported Event|Meropenem|Meropenem 20 mg/kg per dose (up to 1 g/dose) was administered every 8 hours as 30-minutes IV (at least 3 days of IV meropenem only or IV meropenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893439|NCT01110382|E1|Reported Event|Doripenem|Doripenem 20 mg/kg per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes IV (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium). Total duration of treatment 5 to 14 days.
893440|NCT01110330|B4|Baseline|Total|Total of all reporting groups
893441|NCT01110330|B3|Baseline|Ketoconazole|Ketoconazole 2% cream (formulation F126)
893442|NCT01110330|B2|Baseline|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
893443|NCT01110330|B1|Baseline|Placebo|A topical white homogenous cream identical in appearance to study drug
893444|NCT01110330|P3|Participant Flow|Ketoconazole|Ketoconazole 2% cream (formulation F126)
893445|NCT01110330|P2|Participant Flow|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
893446|NCT01110330|P1|Participant Flow|Placebo|A topical white homogenous cream identical in appearance to study drug
893447|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
893448|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
893449|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
893450|NCT01110330|O3|Outcome|Ketoconazole|Ketoconazole 2% cream (formulation F126)
893451|NCT01110330|O2|Outcome|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
893452|NCT01110330|O1|Outcome|Placebo|A topical white homogenous cream identical in appearance to study drug
893453|NCT01110330|E3|Reported Event|Placebo|A topical white homogenous cream identical in appearance to study drug
893454|NCT01110330|E2|Reported Event|Nizoral|Ketoconazole 2% cream (formulation F012) (Nizoral)
893455|NCT01110330|E1|Reported Event|Ketoconazole|Ketoconazole 2% cream (formulation F126)
893456|NCT01110252|B1|Baseline|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
893457|NCT01110252|P1|Participant Flow|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
893458|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
893459|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
893460|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
893461|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
893462|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
893463|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
893464|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
893465|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
893466|NCT01110252|O2|Outcome|Post Procedure (Stem Cells Infusion)|emphysema patients evaluated 30 days after the infusion of autologous stem cells
893467|NCT01110252|O1|Outcome|Prior to the Procedure (Stem Cells Infusion)|emphysema patients evaluated prior to the infusion of autologous stem cells
893468|NCT01110252|E1|Reported Event|Prior Then Post Procedure (Stem Cells Infusion)|emphysema patients evaluated prior or after the infusion of the autologous stem cells
893469|NCT01110239|B5|Baseline|Total|Total of all reporting groups
893470|NCT01110239|B4|Baseline|10 Min Ischemia|
893471|NCT01110239|B3|Baseline|7.5 Min Ischemia|
893472|NCT01110239|B2|Baseline|5 Min Ischemia|
893473|NCT01110239|B1|Baseline|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
893474|NCT01110239|P4|Participant Flow|10-min Ischemia|
893475|NCT01110239|P3|Participant Flow|7.5-min Ischemia|
893476|NCT01110239|P2|Participant Flow|5-min Ischemia|
893477|NCT01110239|P1|Participant Flow|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes. A sham preconditioning group was added with only minimal cuff inflation.
893478|NCT01110239|O4|Outcome|10 Min Ischemia|
893479|NCT01110239|O3|Outcome|7.5 Min Ischemia|
893480|NCT01110239|O2|Outcome|5 Min Ischemia|
893485|NCT01110239|O1|Outcome|Sham Preconditioning|leg preconditioning with increasing durations of ischemia divided into 4 groups: sham preconditioning 3 cycles of 5min blood pressure cuff application 3 times 5 min cycles 3 times 7.5 min cycles 3 times 10 min cycles
893486|NCT01110239|E4|Reported Event|10 Min Ischemia|
893487|NCT01110239|E3|Reported Event|7.5 Min Ischemia|
893488|NCT01110239|E2|Reported Event|5 Min Ischemia|
893489|NCT01110239|E1|Reported Event|Sham Preconditioning|Subjects with subarachnoid hemorrhage will undergo escalating times of limb ischemia to determine tolerability and safety. The leg will be made transiently ischemic with application of a blood pressure cuff for up to 3 cycles of 10 minutes.
893490|NCT01110200|B3|Baseline|Total|Total of all reporting groups
893491|NCT01110200|B2|Baseline|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893492|NCT01110200|B1|Baseline|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893493|NCT01110200|P2|Participant Flow|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893494|NCT01110200|P1|Participant Flow|FSC 250/50|Participants (par.) self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893495|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893496|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893497|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893498|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893499|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893500|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893501|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893502|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893503|NCT01110200|O2|Outcome|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893504|NCT01110200|O1|Outcome|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893505|NCT01110200|E2|Reported Event|SAL 50|Participants self-administered Salmeterol (SAL) 50 µg BID (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893506|NCT01110200|E1|Reported Event|FSC 250/50|Participants self-administered Fluticasone Propionate/Salmeterol (FSC) combination product 250/50 micrograms (µg) twice daily (BID) (one inhalation in the morning and another inhalation in the evening, approximately 12 hours apart) for 29 weeks, approximately.
893507|NCT01110187|B3|Baseline|Total|Total of all reporting groups
893508|NCT01110187|B2|Baseline|IV fPHT|patients randomized to IV fPHT (4)
893509|NCT01110187|B1|Baseline|IV LCM|patients randomized to IV LCM (7)
893510|NCT01110187|P2|Participant Flow|IV fPHT|"Patients randomized to fPHT (fos-phenytoin) with moderate or severe TBI. For IV fPHT dosing and adjustment see Intervention section."
893511|NCT01110187|P1|Participant Flow|IV LCM|"Patients with severe TBI later randomized to seizure prophylaxis with LCM (Lacosamide). For IV LCM dosing and adjustment see Intervention section."
893512|NCT01110187|O2|Outcome|IV fPHT|"Patients with TBI or SAH randomized to seizure prophylaxis with fos-phenytoin~Fosphenytoin: 20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days"
893513|NCT01110187|O1|Outcome|IV LCM|"Patients with severe traumatic brain injury (TBI) or subarachanoid hemorrhage (SAH) randomized to seizure prophylaxis with either lacosamide.~lacosamide: 200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose."
893514|NCT01110187|O2|Outcome|IV fPHT|Patients with severe TBI randomized to seizure prophylaxis with fPHT
893515|NCT01110187|O1|Outcome|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
893516|NCT01110187|E2|Reported Event|IV fPHT|Patients with severe TBI later randomized to seizure prophylaxis with phenytoin.
893517|NCT01110187|E1|Reported Event|IV LCM|Patients with severe TBI later randomized to seizure prophylaxis with lacosamide.
895565|NCT01104584|O3|Outcome|CMRM+XRM|
893518|NCT01110135|B1|Baseline|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
893519|NCT01110135|P1|Participant Flow|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
893520|NCT01110135|O1|Outcome|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
893521|NCT01110135|E1|Reported Event|Treatment (Chemotherapy and Colony-stimulating Factor)|"Patients receive bendamustine hydrochloride IV over 30-60 minutes on days 1 and 2, etoposide IV over 60-240 minutes on days 1-3, dexamethasone PO on days 1-4, and filgrastim SC beginning on day 5 and continuing until peripheral blood stem cell collection is complete. Patients undergo leukapheresis daily for a minimum of 3 days or until > 5 x 10^6 CD34+/kg has been collected.~bendamustine hydrochloride: Given IV~dexamethasone: Given PO~filgrastim: Given SC~leukapheresis: Given IV~laboratory biomarker analysis: Correlative studies~flow cytometry: Correlative studies~etoposide: Given IV"
893522|NCT01110005|B3|Baseline|Total|Total of all reporting groups
893523|NCT01110005|B2|Baseline|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
893524|NCT01110005|B1|Baseline|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
893525|NCT01110005|P2|Participant Flow|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
893526|NCT01110005|P1|Participant Flow|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
893527|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
893528|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
893529|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
893530|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
893531|NCT01110005|O2|Outcome|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
893532|NCT01110005|O1|Outcome|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
893533|NCT01110005|E2|Reported Event|Lactated Ringers Solution (LR)|Non-glucose IV fluid administered throughout labor at an average infusion rate of 125 ml/hr.
893534|NCT01110005|E1|Reported Event|D5 Lactated Ringers Solution (D5LR)|IV fluid containing glucose administered throughout labor at an average infusion rate of 125 ml/hr.
893535|NCT01109979|B3|Baseline|Total|Total of all reporting groups
893536|NCT01109979|B2|Baseline|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
893537|NCT01109979|B1|Baseline|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
893538|NCT01109979|P2|Participant Flow|E+DRSP, Then E+MPA|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
893539|NCT01109979|P1|Participant Flow|E+MPA, Then E+DRSP|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks, then 4 week washout before Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
893540|NCT01109979|O2|Outcome|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
893541|NCT01109979|O1|Outcome|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
893542|NCT01109979|E2|Reported Event|E+DRSP|Estradiol (E) 1 mg orally per day + Drospirenone (DRSP) 0.5 mg orally per day for 6 weeks
893543|NCT01109979|E1|Reported Event|E+MPA|Estradiol (E) 1 mg orally per day + medroxyprogesterone acetate (MPA) 2.5 mg orally per day for 6 weeks
893544|NCT01109602|B4|Baseline|Total|Total of all reporting groups
893545|NCT01109602|B3|Baseline|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
893563|NCT01109576|E1|Reported Event|DSL Workshop Participants|"Dual Sensory Loss (DSL) workshop participants. Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
893596|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
895566|NCT01104584|O2|Outcome|X-ray Mammography (XRM)|
893546|NCT01109602|B2|Baseline|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
893547|NCT01109602|B1|Baseline|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
893548|NCT01109602|P3|Participant Flow|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
893549|NCT01109602|P2|Participant Flow|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
893550|NCT01109602|P1|Participant Flow|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
893551|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
893552|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
893553|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
893554|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
893555|NCT01109602|O2|Outcome|Wait List Control Group|Participants randomized to the Wait list control group were assessed and then waited for 8 weeks for no additional intervention, just usual care. they were then assessed again 8 weeks later.
893556|NCT01109602|O1|Outcome|Yoga/Yoga Plus|Data for both yoga groups were combined for analyses. All participants received 8 weeks of group yoga twice a week. Participants randomized to 'yoga plus' also received an audio recording for meditation/relaxation. there were no differences between groups, thus the data were combined.
893557|NCT01109602|E3|Reported Event|Arm 3: Wait List Control Group|wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.
893558|NCT01109602|E2|Reported Event|Arm 2: Yoga Group Plus|"Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Data for both yoga groups were combined for analyses based off of data from the results.~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
893559|NCT01109602|E1|Reported Event|Arm 1: Yoga Group|"Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance~Yoga intervention focused on strength, flexibility, and balance therapy: Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises."
893560|NCT01109576|B1|Baseline|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
893561|NCT01109576|P1|Participant Flow|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.~Participant Flow Completed: Twelve participants completed the entire protocol, including all outcomes measures."
893562|NCT01109576|O1|Outcome|DSL Workshop Participants|"Three to five Veterans with DSL.~DSL Workshop: A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers."
895567|NCT01104584|O1|Outcome|UMRM|
893564|NCT01109524|B1|Baseline|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893565|NCT01109524|P1|Participant Flow|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893566|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893567|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893568|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893569|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893570|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893591|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893592|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893593|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893571|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893572|NCT01109524|O1|Outcome|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter^2 (m^2), Week 1, then 250mg/m^2 weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI) decision stopped treatment. One hour of observation required after each infusion. Cisplatin administered as IV solution at initial dose of 80mg/m^2 on the first day of each 21 day treatment cycle. Vinorelbine administered as IV solution at initial dose of 25 mg/m^2 on Day 1 and Day 8 of each 21 day treatment cycle. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893573|NCT01109524|E1|Reported Event|Cetuximab + Cisplatin/Vinorelbine|Intravenous (IV) cetuximab, 400mg per meter squared (m²), week 1, then 250mg/m² weekly, until progressive disease (PD) or toxicity or participant-principal investigator (PPI)decision stopped the treatment. One hour of observation required after each infusion. IV cisplatin, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles. Pre-cisplatin hydration could begin during 1-hour post cetuximab observation period. IV vinorelbine, 80mg/m², Day 1 of each 21 day cycle, maximum 6 cycles. One cycle was defined as a 21-day treatment period, unless chemotherapy administration was delayed (cycle duration was longer). All study drugs discontinued if participants experienced PD. If unacceptable toxicities to any study drug occurred, any drug could be modified (reduced, delayed, omitted, or discontinued) independently of the other drugs If no PD, cetuximab could be given as monotherapy after completion of the 6 treatment cycles or after early discontinuation of cis/vin due to intolerance.
893574|NCT01109381|B1|Baseline|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
893575|NCT01109381|P1|Participant Flow|GT08|"Initial phase - omeprazole, N-acetylcysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
893576|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC (N-acetyl cysteine), lauric acid with dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
893577|NCT01109381|O1|Outcome|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
893578|NCT01109381|O1|Outcome|Treatment With GT08|"Initial phase - omeprazole, N-acetyl cysteine (NAC), lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 means treatment with omeprazole 40mg daily, lauric acid 150-300mg daily, and NAC 1.2 - 2g daily"
893579|NCT01109381|E1|Reported Event|Treatment|"Initial phase - omeprazole, NAC, lauric acid dose and duration titration from 1 up to 14 days of treatment. Secondary phase - 14 days treatment with omeprazole, NAC, lauric acid~GT08 : omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily"
893580|NCT01109316|B7|Baseline|Total|Total of all reporting groups
893581|NCT01109316|B6|Baseline|A6D/L6D/L2D|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
893582|NCT01109316|B5|Baseline|A6D/L2D/L6D|Insulin Aspart 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893583|NCT01109316|B4|Baseline|L6D/A6D/L2D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks.
893584|NCT01109316|B3|Baseline|L6D/L2D/A6D|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893585|NCT01109316|B2|Baseline|L2D/A6D/L6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893586|NCT01109316|B1|Baseline|L2D/L6D/A6D|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period, followed by Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks, followed by Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893587|NCT01109316|P3|Participant Flow|Insulin Aspart 6 Day (A6D)|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
893588|NCT01109316|P2|Participant Flow|Insulin Lispro 6 Day (L6D)|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
893589|NCT01109316|P1|Participant Flow|Insulin Lispro 2 Day (L2D)|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 weeks in either Study Period 1, 2, or 3.
893590|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893598|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893599|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893600|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893601|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893602|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893603|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893604|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893605|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893606|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893607|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893608|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893609|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893610|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893611|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893612|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893613|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893614|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893615|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893616|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893617|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893618|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893619|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893620|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893621|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893622|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893623|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893624|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893625|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893626|NCT01109316|O3|Outcome|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893627|NCT01109316|O2|Outcome|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893628|NCT01109316|O1|Outcome|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893629|NCT01109316|E3|Reported Event|Insulin Aspart 6 Day|Insulin Aspart 6 Day (A6D) administered by infusion pump for 8 weeks.
893630|NCT01109316|E2|Reported Event|Insulin Lispro 6 Day|Insulin Lispro 6 Day (L6D) administered by infusion pump for 8 weeks.
893631|NCT01109316|E1|Reported Event|Insulin Lispro 2 Day|Insulin Lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
893632|NCT01109173|B5|Baseline|Total|Total of all reporting groups
893633|NCT01109173|B4|Baseline|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893634|NCT01109173|B3|Baseline|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893635|NCT01109173|B2|Baseline|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893636|NCT01109173|B1|Baseline|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893637|NCT01109173|P4|Participant Flow|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893638|NCT01109173|P3|Participant Flow|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893639|NCT01109173|P2|Participant Flow|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893640|NCT01109173|P1|Participant Flow|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893684|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
893685|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
893641|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893642|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893643|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893644|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893645|NCT01109173|O4|Outcome|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893646|NCT01109173|O3|Outcome|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893647|NCT01109173|O2|Outcome|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893648|NCT01109173|O1|Outcome|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893649|NCT01109173|E4|Reported Event|NEVANAC Vehicle|Nepafenac 0.1% vehicle, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893650|NCT01109173|E3|Reported Event|Nepafenac Vehicle 0.3%|Nepafenac Ophthalmic Suspension 0.3% Vehicle, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893651|NCT01109173|E2|Reported Event|NEVANAC|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery.
893652|NCT01109173|E1|Reported Event|Nepafenac 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily for 16 days, beginning one day prior to surgery, continuing on the day of surgery, and for 14 days following surgery. An additional dose was administered between 30-120 minutes prior to surgery.
893653|NCT01109147|B4|Baseline|Total|Total of all reporting groups
893654|NCT01109147|B3|Baseline|Control|healthy volunteers
893655|NCT01109147|B2|Baseline|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
893656|NCT01109147|B1|Baseline|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
893657|NCT01109147|P3|Participant Flow|Control|healthy volunteers
893658|NCT01109147|P2|Participant Flow|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
893659|NCT01109147|P1|Participant Flow|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
893660|NCT01109147|O3|Outcome|Control|healthy volunteers
893661|NCT01109147|O2|Outcome|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
893662|NCT01109147|O1|Outcome|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
893663|NCT01109147|E3|Reported Event|Control|healthy volunteers
893664|NCT01109147|E2|Reported Event|Risperidone|Schizophrenic patient stabilized under risperidone for six weeks before inclusion
893665|NCT01109147|E1|Reported Event|Aripiprazole|Schizophrenic patient stabilized under aripiprazole for six weeks before inclusion
893666|NCT01109108|B3|Baseline|Total|Total of all reporting groups
893667|NCT01109108|B2|Baseline|Children 2<5 Years of Age|Children 2<5 years of age with and without concurrent respiratory tract infection
893668|NCT01109108|B1|Baseline|Children 0<2 Years of Age|Children 0<2 years of age with and without concurrent respiratory tract infection
893669|NCT01109108|P2|Participant Flow|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
893670|NCT01109108|P1|Participant Flow|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
893671|NCT01109108|O2|Outcome|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
893672|NCT01109108|O1|Outcome|Children 0<2 Years of Age|Children 0<2 years of age with and without respiratory tract infection
893673|NCT01109108|E2|Reported Event|Children 2<5 Years of Age|Children 2<5 years of age with and without respiratory tract infection
893674|NCT01109108|E1|Reported Event|Children <2 Years of Age|Children <2 years of age with and without respiratory tract infection
893675|NCT01109056|B3|Baseline|Total|Total of all reporting groups
893676|NCT01109056|B2|Baseline|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
893677|NCT01109056|B1|Baseline|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
893678|NCT01109056|P2|Participant Flow|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
893679|NCT01109056|P1|Participant Flow|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
893680|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
893681|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
893682|NCT01109056|O2|Outcome|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
893683|NCT01109056|O1|Outcome|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
893686|NCT01109056|E2|Reported Event|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
893687|NCT01109056|E1|Reported Event|Cyclosporine Ophthalmic Emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
893688|NCT01108835|B3|Baseline|Total|Total of all reporting groups
893689|NCT01108835|B2|Baseline|Control Group|Control arm with usual care
893690|NCT01108835|B1|Baseline|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893691|NCT01108835|P2|Participant Flow|Control Group|Control arm with usual care
893692|NCT01108835|P1|Participant Flow|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893693|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
893694|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893695|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
893696|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893697|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
893698|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893699|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
893700|NCT01108835|O1|Outcome|Comprehensive Care Programme|"Comprehensive care involving multidisciplinary input.~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893701|NCT01108835|O2|Outcome|Control Group|Control arm with usual care
893702|NCT01108835|O1|Outcome|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893703|NCT01108835|E2|Reported Event|Control Group|Control arm with usual care
893704|NCT01108835|E1|Reported Event|Comprehensive Care|"Comprehensive care~Comprehensive care programme: Intervention group:~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)~Respiratory physician assessment and optimization of treatment~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
893705|NCT01108809|B1|Baseline|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
893706|NCT01108809|P1|Participant Flow|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
893707|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
893708|NCT01108809|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
893709|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
893710|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
895568|NCT01104584|O3|Outcome|UMRM+XRM|
893713|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
917350|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
893715|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
893716|NCT01108809|O1|Outcome|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
893717|NCT01108809|E1|Reported Event|Micardis® 80 mg/ MicardisPlus® 80/12.5 mg; 80/25 mg|
893718|NCT01108796|B5|Baseline|Total|Total of all reporting groups
893719|NCT01108796|B4|Baseline|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893720|NCT01108796|B3|Baseline|Tool (With Lifestyle Education Tool on Weight Reduction)|
893721|NCT01108796|B2|Baseline|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893722|NCT01108796|B1|Baseline|Micardis® (Telmisartan)|Patients were enrolled into two groups, receiving treatment with Micardis or MicardisPlus and in addition with Tool or No Tool. The system summarizes the number of patients automatically. The total number is always 1841.
893723|NCT01108796|P2|Participant Flow|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
893724|NCT01108796|P1|Participant Flow|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
893725|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893726|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
893727|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893728|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
893729|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893730|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
893731|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893732|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
893733|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893734|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
893735|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893736|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
893737|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893738|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
893739|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893740|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
893741|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893742|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
893743|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893744|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
893745|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893746|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
893747|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893748|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
893749|NCT01108796|O4|Outcome|No Tool (Without Lifestyle Education Tool on Weight Reduction)|
893750|NCT01108796|O3|Outcome|Tool (With Lifestyle Education Tool on Weight Reduction)|
893751|NCT01108796|O2|Outcome|MicardisPlus® (Telmisartan Hydrochlorothiazide)|
893752|NCT01108796|O1|Outcome|Micardis® (Telmisartan)|
893753|NCT01108796|E2|Reported Event|MicardisPlus® (Telmisartan Hydrochlorothiazide)|These patients in addition received Tool or No Tool treatment
893754|NCT01108796|E1|Reported Event|Micardis® (Telmisartan)|These patients in addition received Tool or No Tool treatment
893755|NCT01108731|B3|Baseline|Total|Total of all reporting groups
893756|NCT01108731|B2|Baseline|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
893757|NCT01108731|B1|Baseline|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
893758|NCT01108731|P2|Participant Flow|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
893759|NCT01108731|P1|Participant Flow|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
893760|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
893761|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
893762|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
893763|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
893764|NCT01108731|O2|Outcome|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
893928|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
894119|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
893765|NCT01108731|O1|Outcome|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
893766|NCT01108731|E2|Reported Event|Patients Taking the Placebo|"Placebo: Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
893767|NCT01108731|E1|Reported Event|Patients Taking the Drug Minalcipran|"Milnacipran: Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
893768|NCT01108718|B3|Baseline|Total|Total of all reporting groups
893769|NCT01108718|B2|Baseline|Subjects Who Receive the Control Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
893770|NCT01108718|B1|Baseline|Subjects Who Receive Tempur-Pedic Mattress First(2 Months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
893771|NCT01108718|P2|Participant Flow|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
893772|NCT01108718|P1|Participant Flow|Subjects Who Received the Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
893773|NCT01108718|O1|Outcome|All Participants|All subjects used a tempur-pedic mattress and control mattress to sleep on in a cross over design for a period of 2 months per mattress.
893774|NCT01108718|E2|Reported Event|Subjects Who Received the Control Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
893775|NCT01108718|E1|Reported Event|Subjects Who Received Tempur-Pedic Mattress First|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.
893776|NCT01108523|B1|Baseline|HP828-101|HP828-101 Experimental Formulation
893777|NCT01108523|P1|Participant Flow|HP828-101|HP828-101 Experimental Formulation
893778|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
893779|NCT01108523|O1|Outcome|HP828-101|HP828-101 Experimental Formulation
893780|NCT01108523|E1|Reported Event|HP828-101|HP828-101 Experimental Formulation
893781|NCT01108510|B3|Baseline|Total|Total of all reporting groups
893782|NCT01108510|B2|Baseline|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893783|NCT01108510|B1|Baseline|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893784|NCT01108510|P2|Participant Flow|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893785|NCT01108510|P1|Participant Flow|ATV+COBI+FTC/TDF|Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily
893786|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893787|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893788|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893789|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893790|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893791|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893792|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893793|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893794|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893795|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893796|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893797|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893798|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893799|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893800|NCT01108510|O2|Outcome|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893801|NCT01108510|O1|Outcome|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893802|NCT01108510|E2|Reported Event|ATV+RTV+FTC/TDF|RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893803|NCT01108510|E1|Reported Event|ATV+COBI+FTC/TDF|COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily
893804|NCT01108458|B1|Baseline|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893805|NCT01108458|P1|Participant Flow|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893806|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893986|NCT01107912|P2|Participant Flow|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
893807|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893808|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893809|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893810|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893811|NCT01108458|O1|Outcome|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893812|NCT01108458|E1|Reported Event|Pertuzumab Plus Erlotinib Hydrochloride|"Pertuzumab 840 mg intravenous (IV) single loading dose followed by 420 mg IV every 3 weeks~Erlotinib hydrochloride 150 mg/day by mouth~Pertuzumab: iv, 840 mg, 420 mg~Erlotinib: PO, 150 mg"
893813|NCT01108445|B3|Baseline|Total|Total of all reporting groups
893814|NCT01108445|B2|Baseline|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893815|NCT01108445|B1|Baseline|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893816|NCT01108445|P2|Participant Flow|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893817|NCT01108445|P1|Participant Flow|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893818|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893819|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893820|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893821|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893822|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893823|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893824|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893825|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893826|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893827|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893828|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893829|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893830|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893831|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893832|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893833|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893834|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893835|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893836|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893837|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893838|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893839|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893840|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893841|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893842|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893843|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893844|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893845|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893846|NCT01108445|O2|Outcome|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893847|NCT01108445|O1|Outcome|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893848|NCT01108445|E2|Reported Event|Sunitinib|"Subjects in this treatment arm will take sunitinib 50 mg daily by mouth on days 1 through 28 of each 42 day cycle.~Sunitinib: 50 mg daily by mouth on days 1 through 28 of each 42 day cycle."
893849|NCT01108445|E1|Reported Event|RAD001|"Subjects in this treatment arm will receive everolimus/RAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.~Everolimus: Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle."
893850|NCT01108406|B1|Baseline|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
893851|NCT01108406|P1|Participant Flow|Sonitus SoundBite System|Long Term Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
893852|NCT01108406|O2|Outcome|Global Benefit APHAB Score Aided 6 Months|The Global Benefit APHAB at 6 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 6 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
893853|NCT01108406|O1|Outcome|Global Benefit APHAB Score Aided 3 Months|The Global Benefit APHAB at 3 months endpoint is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 3 months of therapy.The APHAB Questionnaire produces an overall Global score (GBL). The larger the APHAB benefit score the greater the benefit. A negative APHAB benefit score represents therapy resulting in a worse outcome than no therapy.
893854|NCT01108406|O1|Outcome|Number of Participants Experiencing no Adverse Events|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure. Dental measurements included periodontal measurements (bone loss, oral health, bleeding index, calculus, peridontal probing) at baseline compared to 6 months. Audiological included hearing evaluation and aided thresholds baseline compared to 6 months and medical compared medical and ear health baseline compared to 6 months.
893855|NCT01108406|E1|Reported Event|Long Term Safety|Safety was measured in terms of dental, audiological and medical adverse events related to device or procedure.
893856|NCT01108341|B1|Baseline|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
893857|NCT01108341|P1|Participant Flow|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
895569|NCT01104584|O2|Outcome|CMRM+XRM|
893858|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
893859|NCT01108341|O1|Outcome|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
893860|NCT01108341|E1|Reported Event|Bendamustine and Ofatumumab|There are 6 planned and 2 optional 28-day cycles in which participants are administered both bendamustine and ofatumumab in the following doses: Bendamustine administered at 90 mg/m^2 intravenously (iv) on study days 1 and 2. Ofatumumab administered at 300 mg iv on day 1 and 1000 mg iv on day 8 of cycle 1. Ofatumumab administered at 1000 mg iv on day 1 of all additional cycles.
893861|NCT01108263|B3|Baseline|Total|Total of all reporting groups
893862|NCT01108263|B2|Baseline|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893863|NCT01108263|B1|Baseline|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893864|NCT01108263|P2|Participant Flow|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893865|NCT01108263|P1|Participant Flow|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893866|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893867|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893868|NCT01108263|O2|Outcome|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893869|NCT01108263|O1|Outcome|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893870|NCT01108263|E2|Reported Event|INTEGRA Flowable on Wound & Injected Subcutaneously|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893871|NCT01108263|E1|Reported Event|Integra Flowable on Wound Bed|INTEGRA™ Flowable is a wound Matrix made of bovine (cow) collagen. It provides a scaffold for cellular and capillary growth. Dosage is dependent on the size of the wound. It will be applied once.
893872|NCT01108237|B3|Baseline|Total|Total of all reporting groups
893873|NCT01108237|B2|Baseline|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
893874|NCT01108237|B1|Baseline|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
893875|NCT01108237|P2|Participant Flow|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
893876|NCT01108237|P1|Participant Flow|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
893877|NCT01108237|O2|Outcome|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
893878|NCT01108237|O1|Outcome|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
893879|NCT01108237|E2|Reported Event|Total Knee Arthroplasty With Conventional Instrumentation|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
893880|NCT01108237|E1|Reported Event|TruMatch™ Personalized Solutions|Cruciate Retaining and Posterior Stabilized Fixed-Bearing or Rotating Platform Total Knee Arthroplasty (PFC Sigma System) implanted using TruMatch™ Personalized Solutions
893881|NCT01108185|B1|Baseline|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893882|NCT01108185|P1|Participant Flow|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893883|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893884|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
894017|NCT01107912|E3|Reported Event|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
893885|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893886|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893887|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893888|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893889|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893890|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893891|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893892|NCT01108185|O1|Outcome|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893893|NCT01108185|E1|Reported Event|Acute Respiratory Infections|Slovak participants with lower respiratory tract infection or patients with acute exacerbation of chronic bronchitis (AECB) or mild community-acquired pneumonia (CAP) prescribed Klacid SR 1000 mg once daily.
893894|NCT01108081|B5|Baseline|Total|Total of all reporting groups
893895|NCT01108081|B4|Baseline|Combined Physical Activity/Diet|Combined physical activity and diet
893896|NCT01108081|B3|Baseline|Health Education|"Health education~Health education: Attention control intervention"
893897|NCT01108081|B2|Baseline|Diet|"Diet~Diet: Dietary weight loss"
893898|NCT01108081|B1|Baseline|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
893899|NCT01108081|P4|Participant Flow|Combined Physical Activity/Diet|Combined physical activity and diet
893900|NCT01108081|P3|Participant Flow|Health Education|"Health education~Health education: Attention control intervention"
893901|NCT01108081|P2|Participant Flow|Diet|"Diet~Diet: Dietary weight loss"
893902|NCT01108081|P1|Participant Flow|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
893903|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
893904|NCT01108081|O3|Outcome|Health Education|"Health education~Health education: Attention control intervention"
893905|NCT01108081|O2|Outcome|Diet|"Diet~Diet: Dietary weight loss"
893906|NCT01108081|O1|Outcome|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
893907|NCT01108081|O4|Outcome|Combined Physical Activity/Diet|Combined physical activity and diet
893908|NCT01108081|O3|Outcome|Health Education|"Health education~Health education: Attention control intervention"
893909|NCT01108081|O2|Outcome|Diet|"Diet~Diet: Dietary weight loss"
893910|NCT01108081|O1|Outcome|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
893911|NCT01108081|E4|Reported Event|Combined Physical Activity/Diet|Combined physical activity and diet
893912|NCT01108081|E3|Reported Event|Health Education|"Health education~Health education: Attention control intervention"
893913|NCT01108081|E2|Reported Event|Diet|"Diet~Diet: Dietary weight loss"
893914|NCT01108081|E1|Reported Event|Physical Activity|"Physical activity~Physical activity: Moderate-intensity physical activity"
893915|NCT01108055|B1|Baseline|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893916|NCT01108055|P1|Participant Flow|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893917|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893918|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893919|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893920|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893921|NCT01108055|O1|Outcome|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893922|NCT01108055|E1|Reported Event|Pazopanib + Paclitaxel|A trial combining paclitaxel with pazopanib, a commonly used anti-angiogenic agent with significant anti-tumor activity in various solid tumors.
893923|NCT01108003|B3|Baseline|Total|Total of all reporting groups
893924|NCT01108003|B2|Baseline|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
893925|NCT01108003|B1|Baseline|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
893926|NCT01108003|P2|Participant Flow|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
893927|NCT01108003|P1|Participant Flow|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
893929|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
893930|NCT01108003|O2|Outcome|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
893931|NCT01108003|O1|Outcome|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
893932|NCT01108003|E2|Reported Event|Arm 2|"Patients receive mango juice alone.~Mango Juice: given orally"
893933|NCT01108003|E1|Reported Event|Arm I|"Patients receive oral broccoli sprout extract once daily on days 1-14 in the absence of disease progression or unacceptable toxicity.~broccoli sprout extract: Given orally~laboratory biomarker analysis: Correlative studies"
893934|NCT01107925|B5|Baseline|Total|Total of all reporting groups
893935|NCT01107925|B4|Baseline|Dose Sequence: Pras 10mg, Clop 75 mg, Pras 5mg (HBW)|Participants in the HBW group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
893936|NCT01107925|B3|Baseline|Dose Sequence: Pras 10mg, Pras 5mg, Clop 75 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received 10 mg Pras during Study Period 1, followed by 5 mg Pras in Study Period 2, followed by 75 mg Clop in Study Period 3.
893937|NCT01107925|B2|Baseline|Dose Sequence: Pras 5mg, Clop 75 mg, Pras 10mg (LBW)|Participants in the LBW group received 5 mg Pras during Study Period 1, followed by 75 mg Clop in Study Period 2, and 10 mg Pras in Study Period 3.
893938|NCT01107925|B1|Baseline|Dose Sequence: Pras 5mg, Pras 10mg, Clop 75mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received 5 milligrams (mg) of Prasugrel (Pras) during Study Period 1, followed by 10 mg Pras in Study Period 2, followed by 75 mg clopidogrel (Clop) in Study Period 3.
893939|NCT01107925|P6|Participant Flow|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893940|NCT01107925|P5|Participant Flow|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
893941|NCT01107925|P4|Participant Flow|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893942|NCT01107925|P3|Participant Flow|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
893943|NCT01107925|P2|Participant Flow|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893944|NCT01107925|P1|Participant Flow|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
893945|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either 5-mg prasugrel or the 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893946|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the (HBW; ≥ 60 kg) treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
893947|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893948|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Period 1 (on 5 mg prasugrel) were switched to either the 10-mg prasugrel or the 75-mg clopidogrel dose for Period 2 or Period 3.
893949|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893950|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
893951|NCT01107925|O6|Outcome|Clopidogrel 75 mg (HBW)|Participants in the HBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893952|NCT01107925|O5|Outcome|Prasugrel 10 mg (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
893953|NCT01107925|O4|Outcome|Prasugrel 5 mg (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg)treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893954|NCT01107925|O3|Outcome|Clopidogrel 75 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893955|NCT01107925|O2|Outcome|Prasugrel 10 mg (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893956|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
894018|NCT01107912|E2|Reported Event|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
893957|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose during Study Period 2 or Study Period 3.
893958|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
893959|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893960|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
893961|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893962|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; (<60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
893963|NCT01107925|O6|Outcome|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 75-mg clopidogrel or 5-mg prasugrel dose either during Study Period 2 or Study Period 3.
893964|NCT01107925|O5|Outcome|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
893965|NCT01107925|O4|Outcome|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 kg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893966|NCT01107925|O3|Outcome|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
893967|NCT01107925|O2|Outcome|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893968|NCT01107925|O1|Outcome|5 mg Prasugrel (LBW)|During Study Period 1, participants received the 5-milligram (mg) prasugrel dose for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
893969|NCT01107925|O2|Outcome|Prasugrel 10 mg (HBW)|Participants in the higher body weight (HBW; ≥60 kg) group received the 10-mg prasugrel dose in Study Period 1.
893970|NCT01107925|O1|Outcome|Prasugrel 5 mg (LBW)|Participants in the low body weight (LBW; <60 kilograms [kg]) group received the 5-milligram (mg) prasugrel dose in Study Period 1.
893971|NCT01107925|E6|Reported Event|75 mg Clopidogrel (HBW)|Participants in the HBW treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893972|NCT01107925|E5|Reported Event|10 mg Prasugrel (HBW)|During Study Period 1, participants in the HBW treatment sequence received the 10-mg prasugrel dose for 12 days without intervening or terminal washout periods.
893973|NCT01107925|E4|Reported Event|5 mg Prasugrel (HBW)|Participants in the higher body weight (HBW; ≥ 60 mg) treatment sequence in Study Period 1 (10 mg prasugrel) were switched to either the 5-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893974|NCT01107925|E3|Reported Event|75 mg Clopidogrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 75-mg clopidogrel or 10-mg prasugrel dose during Study Period 2 or Study Period 3.
893975|NCT01107925|E2|Reported Event|10 mg Prasugrel (LBW)|Participants in the LBW treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2 or Study Period 3.
893976|NCT01107925|E1|Reported Event|5 mg Prasugrel (LBW)|During Study Period 1, participants received 5 milligrams (mg) prasugrel for 12 days without intervening or terminal washout periods. Participants in the low body weight (LBW; <60 kilograms [kg]) treatment sequence in Study Period 1 (5 mg prasugrel) were switched to either the 10-mg prasugrel or 75-mg clopidogrel dose during Study Period 2.
893977|NCT01107912|B5|Baseline|Total|Total of all reporting groups
893978|NCT01107912|B4|Baseline|Non-Elderly; Drug Sequence BCA|Participants (≥45 to <65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
893979|NCT01107912|B3|Baseline|Non-Elderly; Drug Sequence BAC|Participants (≥45 to <65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
893980|NCT01107912|B2|Baseline|Very Elderly; Drug Sequence ACB|Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
893981|NCT01107912|B1|Baseline|Very Elderly, Drug Sequence ABC|Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
893982|NCT01107912|P6|Participant Flow|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
893983|NCT01107912|P5|Participant Flow|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
893984|NCT01107912|P4|Participant Flow|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
893985|NCT01107912|P3|Participant Flow|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
894072|NCT01107886|P2|Participant Flow|Placebo|Matching Placebo
895570|NCT01104584|O1|Outcome|X-ray Mammography (XRM)|
893987|NCT01107912|P1|Participant Flow|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
893988|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
893989|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
893990|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
893991|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
893992|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
893993|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
893994|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
893995|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
893996|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
893997|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
893998|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
893999|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894000|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
894001|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894002|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
894003|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
894004|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
894005|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894006|NCT01107912|O6|Outcome|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
894007|NCT01107912|O5|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894008|NCT01107912|O4|Outcome|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
894009|NCT01107912|O3|Outcome|75 mg Clopidogrel (Elderly)|Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
894010|NCT01107912|O2|Outcome|10 mg Prasugrel (Elderly)|Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
894011|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894012|NCT01107912|O2|Outcome|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894013|NCT01107912|O1|Outcome|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894014|NCT01107912|E6|Reported Event|75 mg Clopidogrel (Non-Elderly)|Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.
894015|NCT01107912|E5|Reported Event|10 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894016|NCT01107912|E4|Reported Event|5 mg Prasugrel (Non-Elderly)|Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
894285|NCT01107405|B1|Baseline|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894019|NCT01107912|E1|Reported Event|5 mg Prasugrel (Elderly)|Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
894020|NCT01107899|B4|Baseline|Total|Total of all reporting groups
894021|NCT01107899|B3|Baseline|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894022|NCT01107899|B2|Baseline|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894023|NCT01107899|B1|Baseline|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894024|NCT01107899|P3|Participant Flow|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894025|NCT01107899|P2|Participant Flow|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894026|NCT01107899|P1|Participant Flow|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894027|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894028|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894029|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894030|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894031|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894032|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894033|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894034|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894035|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894036|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894037|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894038|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894039|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894040|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894041|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894042|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894043|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894044|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894045|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894046|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894047|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894048|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894049|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894050|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894051|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894052|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894053|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894054|NCT01107899|O1|Outcome|All Treatments|"Clopidogrel 600 mg taken orally, day one, single dose Prasugrel 30 and 60 mg taken orally, day one, single dose~All treatments were combined into one group."
894055|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894056|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894057|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894058|NCT01107899|O2|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894059|NCT01107899|O1|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894060|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894061|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894062|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894063|NCT01107899|O3|Outcome|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894064|NCT01107899|O2|Outcome|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894065|NCT01107899|O1|Outcome|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894066|NCT01107899|E3|Reported Event|Prasugrel 30 mg|Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
894067|NCT01107899|E2|Reported Event|Prasugrel 60 mg|Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
894068|NCT01107899|E1|Reported Event|Clopidogrel 600 mg|Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
894069|NCT01107886|B3|Baseline|Total|Total of all reporting groups
894070|NCT01107886|B2|Baseline|Placebo|Matching Placebo
894071|NCT01107886|B1|Baseline|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
894073|NCT01107886|P1|Participant Flow|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
894074|NCT01107886|O2|Outcome|Placebo|Matching Placebo
894075|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
894076|NCT01107886|O2|Outcome|Placebo|Matching Placebo
894077|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
894078|NCT01107886|O2|Outcome|Placebo|Matching Placebo
894079|NCT01107886|O1|Outcome|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
894080|NCT01107886|E2|Reported Event|Saxagliptin|5 mg once daily in subjects with normal renal function or mild impaired renal function (eGFR >50 mL/min); 2.5 mg once daily in subjects with moderate to severe renal impairment (eGFR ≤50 mL/min).
894081|NCT01107886|E1|Reported Event|Placebo|Matching Placebo
894082|NCT01107834|B3|Baseline|Total|Total of all reporting groups
894083|NCT01107834|B2|Baseline|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894084|NCT01107834|B1|Baseline|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894085|NCT01107834|P2|Participant Flow|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894086|NCT01107834|P1|Participant Flow|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894087|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894088|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894089|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894090|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894091|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894092|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894093|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894094|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894095|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894096|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894097|NCT01107834|O2|Outcome|Exposed to HIV/HAART|HIV-negative children exposed to HIV and HAART in utero
894098|NCT01107834|O1|Outcome|Healthy Control|HIV-negative children born to healthy, HIV-negative women
894099|NCT01107834|E2|Reported Event|Exposed to HIV/HAART|"HIV-negative children exposed to HIV and HAART in utero~No adverse events"
894100|NCT01107834|E1|Reported Event|Healthy Control|"HIV-negative children born to healthy, HIV-negative women~No adverse events"
894101|NCT01107743|B1|Baseline|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894102|NCT01107743|P1|Participant Flow|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894103|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894104|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894105|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894106|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894107|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894108|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894109|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894110|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894111|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
894112|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894113|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894114|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894115|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894116|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894117|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894118|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
895571|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
895572|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
894120|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894121|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894122|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894123|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894124|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894125|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894126|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894127|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894128|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894129|NCT01107743|O4|Outcome|Class4|Participants with Class4 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894130|NCT01107743|O3|Outcome|Class3|Participants with Class3 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894131|NCT01107743|O2|Outcome|Class2|Participants with Class2 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894132|NCT01107743|O1|Outcome|Class1|Participants with Class1 Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894133|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894134|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894135|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894136|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894137|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894138|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894139|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894140|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894141|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894142|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894143|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894144|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894145|NCT01107743|O3|Outcome|ClassⅢ|Participants with Class Ⅲ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894146|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
894147|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894148|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894149|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894150|NCT01107743|O2|Outcome|Female|Female Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
894151|NCT01107743|O1|Outcome|Male|Male Participants who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
894152|NCT01107743|O2|Outcome|With Concomitant Drugs|Participants with Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894153|NCT01107743|O1|Outcome|Without Concomitant Drugs|Participants without Concomitant Drugs who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894154|NCT01107743|O2|Outcome|With Complications|Participants with Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894155|NCT01107743|O1|Outcome|Without Complications|Participants without Complications who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894156|NCT01107743|O2|Outcome|With Renal Dysfunction|Participants with Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894157|NCT01107743|O1|Outcome|Without Renal Dysfunction|Participants without Renal Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894158|NCT01107743|O2|Outcome|With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894159|NCT01107743|O1|Outcome|Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894160|NCT01107743|O2|Outcome|With Familial Hypercholesterolemia|Participants with Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894161|NCT01107743|O1|Outcome|Without Familial Hypercholesterolemia|Participants without Familial Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894162|NCT01107743|O6|Outcome|Type Ⅴ|Participants with expression type Ⅴ Hypercholesterolemia who took Amlodipine /Atorvastatin Combination Tablets according to Japanese Package Insert.
894163|NCT01107743|O5|Outcome|Type Ⅳ|Participants with expression type Ⅳ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894164|NCT01107743|O4|Outcome|Type Ⅲ|Participants with expression type Ⅲ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894165|NCT01107743|O3|Outcome|Type Ⅱb|Participants with expression type Ⅱb Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894166|NCT01107743|O2|Outcome|Type Ⅱa|Participants with expression type Ⅱa Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894167|NCT01107743|O1|Outcome|Type Ⅰ|Participants with expression type Ⅰ Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894168|NCT01107743|O2|Outcome|With Hypercholesterolemia|Participants with Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894169|NCT01107743|O1|Outcome|Without Hypercholesterolemia|Participants without Hypercholesterolemia who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894170|NCT01107743|O2|Outcome|With Angina Pectoris|Participants with Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894171|NCT01107743|O1|Outcome|Without Angina Pectoris|Participants without Angina Pectoris who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894172|NCT01107743|O3|Outcome|ClassⅢ|Participants with ClassⅢ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894173|NCT01107743|O2|Outcome|ClassⅡ|Participants with ClassⅡ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894174|NCT01107743|O1|Outcome|ClassⅠ|Participants with ClassⅠ Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894175|NCT01107743|O2|Outcome|With Hypertension|Participants with Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894176|NCT01107743|O1|Outcome|Without Hypertension|Participants without Hypertension who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894177|NCT01107743|O2|Outcome|>=65 Years|Participants with >=65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894178|NCT01107743|O1|Outcome|<65 Years|Participants with <65 years who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894179|NCT01107743|O2|Outcome|Female|Female participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894180|NCT01107743|O1|Outcome|Male|Male participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894181|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894182|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894183|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894184|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894185|NCT01107743|O1|Outcome|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894186|NCT01107743|E1|Reported Event|Amlodipine and Atorvastatin Combination Tablet|Participants who took Amlodipine/Atorvastatin Combination Tablets according to Japanese Package Insert.
894187|NCT01107730|B4|Baseline|Total|Total of all reporting groups
894188|NCT01107730|B3|Baseline|Placebo|Placebo: Placebo
894189|NCT01107730|B2|Baseline|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
894190|NCT01107730|B1|Baseline|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
894191|NCT01107730|P3|Participant Flow|Placebo|Placebo: Placebo
894192|NCT01107730|P2|Participant Flow|Vitamin C|VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
894193|NCT01107730|P1|Participant Flow|L-Carnitine|L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
894194|NCT01107730|O3|Outcome|Placebo|Placebo: Placebo
894195|NCT01107730|O2|Outcome|Vitamin C|Vitamin C 2 days preoperatively and 4 days postoperatively
894196|NCT01107730|O1|Outcome|L-Carnitine|Carnitine 2 days preoperatively and 4 days postoperatively
894197|NCT01107730|E3|Reported Event|Placebo|Placebo: Placebo
894198|NCT01107730|E2|Reported Event|Vitamin C|"Vitamin C 2 days preoperatively and 4 days postoperatively~Vitamin C: Vitamin C 2 days preoperatively and 4 days postoperatively"
894199|NCT01107730|E1|Reported Event|L-Carnitine|"Carnitine 2 days preoperatively and 4 days postoperatively~Carnitine: Carnitine 2 days preoperatively and 4 days postoperatively"
894215|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894286|NCT01107405|P5|Participant Flow|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894200|NCT01107535|B1|Baseline|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894201|NCT01107535|P1|Participant Flow|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894202|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894203|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894204|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894205|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894206|NCT01107535|O1|Outcome|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894207|NCT01107535|E1|Reported Event|Infants Receiving Synagis (Palivizumab) Immunoprophylaxis|Infants born <= 32 weeks of gestation and are younger than 6 months of age, children with bronchopulmonary dysplasia who have received medical treatment in the last 6 months until the first year of life, and children 12 months or younger with hemodynamically significant acyanotic congenital heart disease (pulmonary hypertension or heart failure in treatment) prescribed Synagis (palivizumab) immunoprophylaxis according to the usual clinical practice.
894208|NCT01107418|B5|Baseline|Total|Total of all reporting groups
894209|NCT01107418|B4|Baseline|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894210|NCT01107418|B3|Baseline|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894211|NCT01107418|B2|Baseline|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894212|NCT01107418|B1|Baseline|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894213|NCT01107418|P1|Participant Flow|Vemurafenib – All Cohorts|Participants received vemurafenib (RO5185426) film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 milligrams (mg) on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894214|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894281|NCT01107405|B5|Baseline|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894282|NCT01107405|B4|Baseline|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894216|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894217|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894218|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894219|NCT01107418|O1|Outcome|Vemurafenib – All Cohorts|Participants received vemurafenib film-coated tablets, orally, twice daily at doses of 240, 480, 720, or 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894220|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894221|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894222|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894223|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film coated tablet twice daily orally in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894224|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894225|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894226|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894227|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894228|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894229|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894230|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894231|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
895573|NCT01104584|O1|Outcome|CMRM Versus UMRM|
895574|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
894232|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894233|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894234|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894235|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894236|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894237|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894238|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894239|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894240|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894241|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894242|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894243|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894244|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894245|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894246|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894247|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894283|NCT01107405|B3|Baseline|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894248|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894249|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894250|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894251|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894252|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894253|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894254|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894255|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894256|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894257|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894258|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894259|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894260|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894261|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894262|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894263|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894284|NCT01107405|B2|Baseline|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894264|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894265|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894266|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894267|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894268|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894269|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894270|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894271|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894272|NCT01107418|O4|Outcome|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894273|NCT01107418|O3|Outcome|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894274|NCT01107418|O2|Outcome|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894275|NCT01107418|O1|Outcome|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894276|NCT01107418|E4|Reported Event|Cohort 4 - Vemurafenib 960 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 960 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants resumed vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894277|NCT01107418|E3|Reported Event|Cohort 3 - Vemurafenib 720 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 720 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894278|NCT01107418|E2|Reported Event|Cohort 2 - Vemurafenib 480 mg|Participants received vemurafenib film-coated tablets, orally, twice daily at a dose of 480 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894279|NCT01107418|E1|Reported Event|Cohort 1 - Vemurafenib 240 mg|Participants received vemurafenib film-coated tablet, orally, twice daily at a dose of 240 mg on Days 1 to 15 (a single morning dose was administered on Day 15). Starting at Day 22, participants received vemurafenib 960 mg film-coated tablets orally twice daily in 21-day cycles until the development of progressive disease, unacceptable toxicity, consent withdrawal, or any other criteria for removal.
894280|NCT01107405|B6|Baseline|Total|Total of all reporting groups
895575|NCT01104584|O2|Outcome|CMRM vs XRM|
894287|NCT01107405|P4|Participant Flow|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894288|NCT01107405|P3|Participant Flow|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894289|NCT01107405|P2|Participant Flow|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894290|NCT01107405|P1|Participant Flow|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894291|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894292|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894293|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894294|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894295|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894296|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894297|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894298|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894299|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894300|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894301|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894302|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894303|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894304|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894305|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894306|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894307|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894308|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894309|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894310|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894311|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894312|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894313|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894314|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894315|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894316|NCT01107405|O5|Outcome|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894317|NCT01107405|O4|Outcome|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894318|NCT01107405|O3|Outcome|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894319|NCT01107405|O2|Outcome|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894320|NCT01107405|O1|Outcome|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894321|NCT01107405|E5|Reported Event|Vehicle of Loteprednol Etabonate|Vehicle of loteprednol etabonate, dosed either QD, BID, or QID
894322|NCT01107405|E4|Reported Event|Loteprednol Etabonate Suspension (QID)|Loteprednol etabonate ophthalmic suspension dosed four times/day
894323|NCT01107405|E3|Reported Event|Loteprednol Etabonate Base (QID)|Loteprednol etabonate ophthalmic base dosed four times/day.
894324|NCT01107405|E2|Reported Event|Loteprednol Etabonate Base (BID)|Loteprednol etabonate ophthalmic base dosed two times/day
894325|NCT01107405|E1|Reported Event|Loteprednol Etabonate Base (QD)|Loteprednol etabonate ophthalmic base dosed once/day.
894326|NCT01107392|B3|Baseline|Total|Total of all reporting groups
894327|NCT01107392|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
894328|NCT01107392|B1|Baseline|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
894329|NCT01107392|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
894330|NCT01107392|P1|Participant Flow|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
894331|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
894332|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
894333|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
894334|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
894335|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
894336|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
894337|NCT01107392|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
894338|NCT01107392|O1|Outcome|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
894339|NCT01107392|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
894340|NCT01107392|E1|Reported Event|Botulinum Toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
894341|NCT01107379|B1|Baseline|Balloon Catheter Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for sinus dilation"
894342|NCT01107379|P1|Participant Flow|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894343|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894344|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894345|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894346|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894347|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894348|NCT01107379|O1|Outcome|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894349|NCT01107379|E1|Reported Event|Balloon Device|"Dilation of sinuses using balloon catheter tools~Relieva Balloon Sinuplasty System: Sinuplasty balloon tools for dilation of sinuses"
894350|NCT01107353|B3|Baseline|Total|Total of all reporting groups
894351|NCT01107353|B2|Baseline|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894352|NCT01107353|B1|Baseline|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894353|NCT01107353|P2|Participant Flow|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894354|NCT01107353|P1|Participant Flow|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894355|NCT01107353|O2|Outcome|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894356|NCT01107353|O1|Outcome|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894357|NCT01107353|E2|Reported Event|First Tofranil PM, Then Imipramine Pamoate|"First 75 mg Tofranil-PM capsule, then 75 mg imipramine pamoate capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894358|NCT01107353|E1|Reported Event|First Imipramine Pamoate, Then Tofranil-PM|"First 75 mg imipramine pamoate capsule, then 75 mg Tofranil-PM capsule (after washout period)~Imipramine Pamoate: 75 mg capsule"
894359|NCT01107197|B3|Baseline|Total|Total of all reporting groups
894360|NCT01107197|B2|Baseline|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894361|NCT01107197|B1|Baseline|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894362|NCT01107197|P2|Participant Flow|Enriched Nutrition Formula|"Patients were given standard diet plus two bottles/day (400 mL) of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements for 8 weeks~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894363|NCT01107197|P1|Participant Flow|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bottles/day (200 mL each; in 4 boluses [100 mL each] spread throughout the day) of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one for 8 weeks~Control formula : Isonitrogenous isocaloric oral formula"
894364|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894365|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894366|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894367|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894368|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894369|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894503|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
895096|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
894370|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894371|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894372|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894373|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894374|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894375|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894376|NCT01107197|O2|Outcome|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894377|NCT01107197|O1|Outcome|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894378|NCT01107197|E2|Reported Event|Isonitrogenous Isocaloric Formula|"Patients were given standard diet plus 2 bricks of an hypercaloric oral formula isonitrogenous isocaloric to the experimental one~Control formula : Isonitrogenous isocaloric oral formula"
894379|NCT01107197|E1|Reported Event|Enriched Nutrition Formula|"Patients were given standard diet plus two brick of an hypercaloric oral formula enriched in arginine, zinc and antioxidant oligoelements~Enriched nutrition formula : oral formula enriched in arginine, zinc and antioxidant oligoelements"
894380|NCT01106976|B1|Baseline|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients
894381|NCT01106976|P1|Participant Flow|Group 1 Parkinson Disease Subjects|Prospective cohort study. 59 PD patients; Hoehn and Yahr stage 1-3) underwent [C-11]methyl-4-piperidinyl propionate (PMP) acetylcholinesterase (AChE) brain PET imaging at baseline and at 3-4 year follow-up. AChE PET imaging assesses cholinergic terminal integrity with cortical uptake reflecting largely basal forebrain neuron integrity and thalamic uptake principally reflecting pedunculopontine nucleus integrity.
894382|NCT01106976|O1|Outcome|Parkinson Disease|Prospective cohort study of Parkinson disease subjects.
894383|NCT01106976|E1|Reported Event|Parkinson|Longitudinal cohort
894384|NCT01106950|B1|Baseline|Evaluable (Treated) Patients|Patients are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894385|NCT01106950|P1|Participant Flow|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894386|NCT01106950|O2|Outcome|Evaluable (Treated) Patients (Expansion=Yes)|KIR mismatched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894387|NCT01106950|O1|Outcome|Evaluable (Treated) Patients (Expansion=No)|KIR matched: Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894388|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894389|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894390|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894391|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894392|NCT01106950|O1|Outcome|Evaluable (Treated) Patients|Patients with acute myeloid leukemia (AML) were treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894393|NCT01106950|E1|Reported Event|Treated Patients|Patients with acute myeloid leukemia (AML) are treated with donor natural killer cells, fludarabine, cyclophosphamide, Denileukin diftitox, Donor lymphapheresis and IL-2.
894394|NCT01106911|B1|Baseline|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
894395|NCT01106911|P1|Participant Flow|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
894396|NCT01106911|O1|Outcome|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
894397|NCT01106911|E1|Reported Event|Digital Breast Tomosynthesis (DBT)|Consented and eligible women undergoing baseline screening mammography received DBT
894398|NCT01106859|B1|Baseline|Total Population|All participants in this four-way cross-over study
894399|NCT01106859|P1|Participant Flow|Total Population|All participants in this four-way cross-over study
894400|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
894401|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
895576|NCT01104584|O1|Outcome|CMRM Versus UMRM|
894402|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894403|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894404|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894405|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894406|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894407|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
894408|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894409|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894410|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894411|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894412|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894413|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894414|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
894415|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894416|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894417|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894418|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894419|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894420|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894421|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
894422|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894423|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894424|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894425|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
894426|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894427|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894428|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894429|NCT01106859|O4|Outcome|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
894430|NCT01106859|O3|Outcome|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894431|NCT01106859|O2|Outcome|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894432|NCT01106859|O1|Outcome|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894433|NCT01106859|E4|Reported Event|Placebo|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is a placebo matching zolpidem tartrate sublingual tablet.
894434|NCT01106859|E3|Reported Event|Zopiclone|Zopiclone (7.5 mg tablet) is taken at bedtime 9 hours before driving. The middle-of-the-night medication is a placebo matching zolpidem tartrate sublingual tablet.
894504|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894435|NCT01106859|E2|Reported Event|Zolpidem 3 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is zolpidem tartrate sublingual tablet taken 3 hours prior to driving.
894436|NCT01106859|E1|Reported Event|Zolpidem 4 Hours Prior|A placebo matching zopiclone is taken at bedtime. The middle-of-the-night treatment is 3.5 mg zolpidem tartrate sublingual tablet taken 4 hours prior to driving.
894437|NCT01106846|B3|Baseline|Total|Total of all reporting groups
894438|NCT01106846|B2|Baseline|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
894439|NCT01106846|B1|Baseline|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
894440|NCT01106846|P2|Participant Flow|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
894441|NCT01106846|P1|Participant Flow|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
894442|NCT01106846|O2|Outcome|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
894443|NCT01106846|O1|Outcome|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
894444|NCT01106846|E2|Reported Event|Group B: 1% Ketamine Group|"Group B: Infusion of ketamine 1% intravenously~Group B: 1% Ketamine group: Administration of 1% ketamine intravenously."
894445|NCT01106846|E1|Reported Event|Group A: Saline Group|"Group A: Saline group , infusion of saline intravenously~Group A: Saline Group: Saline continuous infusion"
894446|NCT01106690|B4|Baseline|Total|Total of all reporting groups
894447|NCT01106690|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894448|NCT01106690|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894449|NCT01106690|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894450|NCT01106690|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894451|NCT01106690|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894452|NCT01106690|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894453|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894454|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894455|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894456|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894457|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894458|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894459|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894460|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894461|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894462|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894463|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894464|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894465|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894466|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894467|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894468|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894469|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894505|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
895577|NCT01104584|O3|Outcome|CMRM vs CMRM+XRM|
894470|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894471|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894472|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894473|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894474|NCT01106690|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894475|NCT01106690|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone.
894476|NCT01106690|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52.
894477|NCT01106690|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
894478|NCT01106690|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 52.
894479|NCT01106690|E4|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 52.
894480|NCT01106690|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
894481|NCT01106690|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with stable doses of metformin and pioglitazone. Data are presented for Baseline to Week 26.
894482|NCT01106690|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks with stable doses of metformin and pioglitazone. At Week 26, patients were switched from placebo to 100 mg of sitagliptin once daily with stable doses of metformin and pioglitazone until Week 52. Data are presented for Baseline to Week 26.
894483|NCT01106677|B5|Baseline|Total|Total of all reporting groups
894484|NCT01106677|B4|Baseline|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894485|NCT01106677|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894486|NCT01106677|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894487|NCT01106677|B1|Baseline|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894488|NCT01106677|P4|Participant Flow|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894489|NCT01106677|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894490|NCT01106677|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894491|NCT01106677|P1|Participant Flow|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894492|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894493|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894494|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894495|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894496|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894497|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894498|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894499|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894500|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894501|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894502|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894506|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894507|NCT01106677|O3|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894508|NCT01106677|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894509|NCT01106677|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894510|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894511|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894512|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894513|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894514|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894515|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894516|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894517|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894518|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894519|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894520|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894521|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894522|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894523|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894524|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894525|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894526|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894527|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894528|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894529|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894530|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894531|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894532|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894533|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894534|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894535|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894536|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894537|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894538|NCT01106677|O4|Outcome|Sitagliptin 100 mg|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894539|NCT01106677|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
895578|NCT01104584|O2|Outcome|CMRM vs XRM|
894540|NCT01106677|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release.
894541|NCT01106677|O1|Outcome|Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release.
894542|NCT01106677|E8|Reported Event|Sitagliptin 100mg: Baseline to Week 52|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
894543|NCT01106677|E7|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
894544|NCT01106677|E6|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
894545|NCT01106677|E5|Reported Event|Placebo/Sitagliptin: Baseline to Week 52|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 52.
894546|NCT01106677|E4|Reported Event|Sitagliptin 100 mg: Baseline to Week 26|Each patient received 100 mg of sitagliptin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
894547|NCT01106677|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
894548|NCT01106677|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
894549|NCT01106677|E1|Reported Event|Placebo/Sitagliptin: Baseline to Week 26|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Placebo and sitagliptin were given with protocol-specified doses of metformin immediate release. Data are presented for Baseline to Week 26.
894550|NCT01106651|B4|Baseline|Total|Total of all reporting groups
894551|NCT01106651|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894552|NCT01106651|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894553|NCT01106651|B1|Baseline|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894554|NCT01106651|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894555|NCT01106651|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894556|NCT01106651|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894557|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894558|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894559|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894560|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894561|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894562|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894563|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894564|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894565|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894566|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894567|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894568|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894569|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894570|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
895095|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
894571|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894572|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894573|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894574|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894575|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894576|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894577|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894578|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894579|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894580|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894581|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894582|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894583|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894584|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894585|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894586|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894587|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894588|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894589|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894590|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894591|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894592|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894593|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894594|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894595|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894596|NCT01106651|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894597|NCT01106651|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894598|NCT01106651|O1|Outcome|Placebo|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry.
894599|NCT01106651|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
894600|NCT01106651|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104
894601|NCT01106651|E4|Reported Event|Placebo: Baseline to Week 104|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 104.
894602|NCT01106651|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
894640|NCT01106586|B2|Baseline|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894603|NCT01106651|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
894604|NCT01106651|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 104 weeks in addition to being on a stable antihyperglycemic (AHA) regimen at the time of study entry. Data are presented for Baseline to Week 26.
894605|NCT01106625|B4|Baseline|Total|Total of all reporting groups
894606|NCT01106625|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894607|NCT01106625|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894608|NCT01106625|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894609|NCT01106625|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894610|NCT01106625|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894611|NCT01106625|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894612|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894613|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894614|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894615|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894616|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894617|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894618|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894619|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894620|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894621|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894622|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894623|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894624|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894625|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894626|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894627|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894628|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894629|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894630|NCT01106625|O3|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894631|NCT01106625|O2|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894632|NCT01106625|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
894633|NCT01106625|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
894634|NCT01106625|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
894635|NCT01106625|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 52.
894636|NCT01106625|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
894637|NCT01106625|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
894638|NCT01106625|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea. Data are presented for Baseline to Week 26.
894639|NCT01106586|B3|Baseline|Total|Total of all reporting groups
894641|NCT01106586|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894642|NCT01106586|P2|Participant Flow|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894643|NCT01106586|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) plus placebo to match atazanavir/ritonavir (ATV/r) + FTC/TDF once daily
894644|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894645|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894646|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894647|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894648|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894649|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894650|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894651|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894652|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894653|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894654|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894655|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894656|NCT01106586|O2|Outcome|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894657|NCT01106586|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894658|NCT01106586|E2|Reported Event|ATV/r + FTC/TDF|ATV/r 300/100 mg tablet plus FTC 200 mg/TDF 300 mg tablet plus placebo to match Stribild once daily
894659|NCT01106586|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) plus placebo to match ATV/r + FTC/TDF once daily
894660|NCT01106534|B1|Baseline|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
894661|NCT01106534|P1|Participant Flow|Second Enrollment Phase of XIENCE V® USA|"Additional 3000 patients recruited in the second enrollment phase treated with the XIENCE V EECSS who are free from events (death, MI, repeat coronary revascularization, stroke, ST, or major bleeding - severe or moderate by GUSTO classification) in the first year after the index procedure, and are compliant with DAPT will be identified as prospective patients for the AV-DAPT cohort. A total of 870 Patients who are considered as part of the AV-DAPT cohort will continue with Aspirin therapy and will be randomized at 12 months post index procedure to 18 months of either active treatment with thienopyridines or placebo. Clinical follow-up will occur at 15, 24, 30 and 33 months. These patients will be followed by Abbott Vascular."
894662|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894663|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894664|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894665|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894666|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894759|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894667|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894668|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894669|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894670|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894671|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894672|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894673|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894674|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894675|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894676|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894677|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894678|NCT01106534|O2|Outcome|30 Month DAPT Arm|"clopidogrel + aspirin OR prasugrel + aspirin~clopidogrel + aspirin OR prasugrel + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin."
894679|NCT01106534|O1|Outcome|12 Month DAPT Arm|"placebo + aspirin~placebo + aspirin: This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin."
894680|NCT01106534|E1|Reported Event|Second Enrollment Phase of XIENCE V® USA|The participants enrolled in this study will be followed by Abbott Vascular but their data will not be independently analyzed; they will only be analyzed as part of the DAPT study (NCT00977938) which is sufficiently powered for the study outcomes.
894681|NCT01106456|B3|Baseline|Total|Total of all reporting groups
894682|NCT01106456|B2|Baseline|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
894761|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
895579|NCT01104584|O1|Outcome|CMRM Versus UMRM|
894683|NCT01106456|B1|Baseline|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
894684|NCT01106456|P2|Participant Flow|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
894685|NCT01106456|P1|Participant Flow|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)"
894686|NCT01106456|O2|Outcome|Nontailored Program (NT)|All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the Nontailored program (NT).
894687|NCT01106456|O1|Outcome|All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into the culturally-tailored All Nations Breath of Life program (ANBL)."
894688|NCT01106456|E2|Reported Event|Experimental 2: Nontailored Program (NT)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).~Experimental 2: Nontailored program (NT): The nontailored intervention includes the medicines listed above to all participants and targeted counseling delivered by non-American Indian counselors who have worked closely with the American Indian communities and respect the cultures, values, and traditions of the Indian people. Therefore, our intervention includes the current best practice recommendations for smoking cessation. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.~Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
894689|NCT01106456|E1|Reported Event|Experimental 1: All Nations Breath of Life Program (ANBL)|"All participants in the proposed study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT) then randomized into either the culturally-tailored All Nations Breath of Life program (ANBL) or Nontailored program (NT).~Experimental 1: All Nations Breath of Life program (ANBL): ANBL consists of in-person group sessions and individual telephone calls. We have successfully conducted a pilot study of ANBL and have found very promising results. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.~Pharmacotherapy (e.g. Varenicline or Bupropion or NRT): Pharmacotherapy (e.g. Varenicline or Bupropion or NRT)"
894690|NCT01106430|B3|Baseline|Total|Total of all reporting groups
894691|NCT01106430|B2|Baseline|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894692|NCT01106430|B1|Baseline|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894693|NCT01106430|P2|Participant Flow|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894694|NCT01106430|P1|Participant Flow|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894695|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894696|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894697|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894698|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894699|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894700|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894701|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894702|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894703|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894704|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894705|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894706|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894707|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894708|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894709|NCT01106430|O2|Outcome|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894710|NCT01106430|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894711|NCT01106430|E2|Reported Event|Atomoxetine Hydrochloride|Atomoxetine Hydrochloride (Strattera) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at weight adjusted doses of 10 mg to 100 mg.
894712|NCT01106430|E1|Reported Event|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate (LDX, Vyvanse, SPD489) was administered orally once-daily at approximately 7:00am for 9 weeks (4-week dose optimization period and a 5-week dose maintenance period) at doses of either 30, 50, or 70 mg.
894713|NCT01106404|B3|Baseline|Total|Total of all reporting groups
894714|NCT01106404|B2|Baseline|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
894715|NCT01106404|B1|Baseline|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
894716|NCT01106404|P2|Participant Flow|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
894717|NCT01106404|P1|Participant Flow|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
894718|NCT01106404|O4|Outcome|NPRS at 16 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
894719|NCT01106404|O3|Outcome|NPRS at Baseline (Subject With Score at 16 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 16 weeks post-implant
894720|NCT01106404|O2|Outcome|NPRS at 10 Weeks Post-implant|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
894721|NCT01106404|O1|Outcome|NPRS at Baseline (Subject With Score at 10 Weeks Post-implant)|Included subjects with NPRS scores from both baseline and 10 weeks post-implant
894722|NCT01106404|O2|Outcome|Manual Treatment Arm|Subjects in manual treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim OFF.
894723|NCT01106404|O1|Outcome|AdaptiveStim Treatment Arm|Subjects in AdaptiveStim treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim ON.
894724|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStime Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
894725|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
894726|NCT01106404|O2|Outcome|6-week Manual Followed by 6-week AdaptiveStim Programming|Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.
894727|NCT01106404|O1|Outcome|6-week AdaptiveStim Followed by 6-week Manual Programming|Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.
894728|NCT01106404|E1|Reported Event|Overall Adverse Events|Overall adverse events were reported.
894729|NCT01106391|B1|Baseline|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
894730|NCT01106391|P1|Participant Flow|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
894731|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
894732|NCT01106391|O1|Outcome|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
894760|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
895580|NCT01104584|O1|Outcome|CMRM|
894733|NCT01106391|E1|Reported Event|The INCRAFT™ AAA Stent-graft System|The Cordis INCRAFT™ AAA stent-graft system is a modular bifurcated endovascular graft system that is used for the treatment of infrarenal abdominal aortic aneurysms (AAA). The system is constructed with self-expanding, nickel-titanium (nitinol) alloy stent rings and woven polyester graft tubes. The bifurcated aortic prosthesis includes a transrenal stent with integrated fixation barbs. The limbs include annular fabric crimps between the supporting stents.
894734|NCT01106352|B6|Baseline|Total|Total of all reporting groups
894735|NCT01106352|B5|Baseline|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894736|NCT01106352|B4|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894737|NCT01106352|B3|Baseline|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894738|NCT01106352|B2|Baseline|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894739|NCT01106352|B1|Baseline|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894740|NCT01106352|P5|Participant Flow|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894741|NCT01106352|P4|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894742|NCT01106352|P3|Participant Flow|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894743|NCT01106352|P2|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894744|NCT01106352|P1|Participant Flow|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894745|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894746|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894747|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894748|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894749|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894750|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894751|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894752|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894753|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894754|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894755|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894756|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894757|NCT01106352|O2|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894758|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894762|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894763|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894764|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894765|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894766|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894767|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894768|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894769|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894770|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894771|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894772|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894773|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894774|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894775|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894776|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894777|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894778|NCT01106352|O3|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894779|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894780|NCT01106352|O1|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894781|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894782|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894825|NCT01106352|E4|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894783|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894784|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894785|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894786|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894787|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894788|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894789|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894790|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894791|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894792|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894793|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894794|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894795|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894796|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894797|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894798|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894799|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894800|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894801|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894802|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894803|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
895026|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895581|NCT01104584|O1|Outcome|CMRM|
895582|NCT01104584|O2|Outcome|UMRM|
894804|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894805|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894806|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894807|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894808|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894809|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894810|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894811|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894812|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894813|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894814|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894815|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894816|NCT01106352|O5|Outcome|Docetaxel 75 mg/m^2 – Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks.
894817|NCT01106352|O4|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 – Safety Cohort|Subjects received five intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks.
894818|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894819|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894820|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894821|NCT01106352|O3|Outcome|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894822|NCT01106352|O2|Outcome|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894823|NCT01106352|O1|Outcome|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 mg/m^2 every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation.
894824|NCT01106352|E5|Reported Event|Docetaxel 75 mg/m^2 - Safety Cohort|Subjects received docetaxel at 75 mg/m^2 twice daily every three weeks
895027|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
894826|NCT01106352|E3|Reported Event|Alpharadin 50 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 50 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894827|NCT01106352|E2|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 60 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin at a dose of 25 kBq/kg body weight based on NIST 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 60 mg/m^2 every three weeks; unless DLT or other safety concerns limited the dose escalation.
894828|NCT01106352|E1|Reported Event|Alpharadin 25 kBq/kg + Docetaxel 75 mg/m^2 - Dose Escalation|Subjects received two intravenous injections of Alpharadin (Radium [Ra]-223 dichloride, BAY88-8223) at a dose of 25 kBq/kg body weight based on National Institute of Standards and Technology (NIST) 2010 standardization, separated by an interval of six weeks in combination with docetaxel at 75 milligram per square meter (mg/m^2) every three weeks; unless dose limiting toxicity (DLT) or other safety concerns limited the dose escalation
894829|NCT01106326|B1|Baseline|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
894830|NCT01106326|P1|Participant Flow|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
894831|NCT01106326|O3|Outcome|Four Months Post Baseline|
894832|NCT01106326|O2|Outcome|Two Months Post Baseline|
894833|NCT01106326|O1|Outcome|Baseline|
894834|NCT01106326|E1|Reported Event|Intervention|"Teens participating in this study will have:~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen’s motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
894835|NCT01106287|B5|Baseline|Total|Total of all reporting groups
894836|NCT01106287|B4|Baseline|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
894837|NCT01106287|B3|Baseline|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
894838|NCT01106287|B2|Baseline|MK-0941 60/80/Pbo/ MK-0941 120/140 mg|Treatment Sequence 2
894839|NCT01106287|B1|Baseline|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
894840|NCT01106287|P4|Participant Flow|Pbo/MK-0941 80/100 mg/Pbo/MK-0941 140 mg|Treatment Sequence 4
894841|NCT01106287|P3|Participant Flow|MK-0941 60 mg/Pbo/MK-0941 100/120/140 mg|Treatment Sequence 3
894842|NCT01106287|P2|Participant Flow|MK-0941 60/80 mg/Pbo/MK-0941 120/140 mg|Treatment Sequence 2
894843|NCT01106287|P1|Participant Flow|MK-0941 60/80/100/120 mg/Pbo|Treatment Sequence 1
894844|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
894845|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
894846|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
894847|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
894848|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
894849|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
894850|NCT01106287|O6|Outcome|Placebo|All participants receiving placebo
894851|NCT01106287|O5|Outcome|MK-0941 140 mg|All participants receiving a 140-mg dose of MK-0941
894852|NCT01106287|O4|Outcome|MK-0941 120 mg|All participants receiving a 120-mg dose of MK-0941
894853|NCT01106287|O3|Outcome|MK-0941 100 mg|All participants receiving a 100-mg dose of MK-0941
894854|NCT01106287|O2|Outcome|MK-0941 80 mg|All participants receiving a 80-mg dose of MK-0941
894855|NCT01106287|O1|Outcome|MK-0941 60 mg|All participants receiving a 60-mg dose of MK-0941
894856|NCT01106287|E6|Reported Event|Placebo|All participants receiving placebo
894857|NCT01106287|E5|Reported Event|MK-0941 140 mg|All participants receiving at least one dose of 140 mg of MK-0941
894858|NCT01106287|E4|Reported Event|MK-0941 120 mg|All participants receiving at least one dose of 120 mg of MK-0941
894859|NCT01106287|E3|Reported Event|MK-0941 100 mg|All participants receiving at least one dose of 100 mg of MK-0941
894860|NCT01106287|E2|Reported Event|MK-0941 80 mg|All participants receiving at least one dose of 80 mg of MK-0941
894861|NCT01106287|E1|Reported Event|MK-0941 60 mg|All participants receiving at least one dose of 60 mg of MK-0941
894862|NCT01105767|B4|Baseline|Total|Total of all reporting groups
894863|NCT01105767|B3|Baseline|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
894864|NCT01105767|B2|Baseline|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
894923|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894865|NCT01105767|B1|Baseline|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency registered disinfectants.
894866|NCT01105767|P3|Participant Flow|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
894867|NCT01105767|P2|Participant Flow|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
894868|NCT01105767|P1|Participant Flow|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard standard Environmental Protection Agency registered disinfectants.
894869|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
894870|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
894871|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
894872|NCT01105767|O3|Outcome|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
894873|NCT01105767|O2|Outcome|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
894874|NCT01105767|O1|Outcome|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic (TMC). High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
894875|NCT01105767|E3|Reported Event|Group 3 Chlorhexidine|Trainees received the components of the Standard and Enhanced Standard groups and were offered chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) to use with a wash cloth after using their personal soap for the additional once-weekly shower. Trainees were provided with verbal and written/graphic instructions for use.
894876|NCT01105767|E2|Reported Event|Group 2 Enhanced Standard|Trainees received the components of the Standard group and were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit. Supplemental SSTI education for trainees and drill sergeants was also provided (e.g., pocket cards, posters). Drill sergeants received briefings on SSTI and skin inspection/minor wound care.
894877|NCT01105767|E1|Reported Event|Group 1 Standard|Trainees received a preventive medicine briefing augmented with SSTI and MRSA SSTI prevention information and personal hygiene instructions. Trainees seeking medical care for an SSTI received standardized SSTI care (e.g., antimicrobial therapy, wound management, patient education) at the Troop Medical Clinic. High-touch common surfaces within the battalion areas were cleaned with standard Environmental Protection Agency-registered disinfectants.
894878|NCT01106248|B1|Baseline|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
894879|NCT01106248|P1|Participant Flow|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
894880|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
894881|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
894882|NCT01106248|O1|Outcome|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
894883|NCT01106248|E1|Reported Event|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
894884|NCT01106157|B3|Baseline|Total|Total of all reporting groups
894885|NCT01106157|B2|Baseline|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
895028|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
895583|NCT01104584|O1|Outcome|CMRM|
894886|NCT01106157|B1|Baseline|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894887|NCT01106157|P2|Participant Flow|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner.~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes."
894888|NCT01106157|P1|Participant Flow|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose) given subcutaneously every 2 weeks beginning after the ATG infusion."
894889|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894890|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894891|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894892|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894893|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894894|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894895|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894896|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894897|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894898|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894899|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894900|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894901|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894902|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894903|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894943|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894904|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894905|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894906|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894907|NCT01106157|O2|Outcome|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894908|NCT01106157|O1|Outcome|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894909|NCT01106157|E2|Reported Event|Placebo|"Saline infusion will be given on both Day 1 and Day 2 followed by placebo injection given in identical volumes in identical syringes in the identical subcutaneous manner~Placebo: Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes"
894910|NCT01106157|E1|Reported Event|Anti-Thymocyte Globin Plus Pegylated GCSF|"Subjects will receive an infusion of Anti-Thymocyte Globin (ATG) followed by 6 doses of pegylated GCSF every 2 weeks for 10 weeks.~Anti-Thymocyte Globin plus pegylated GCSF: Anti-Thymocyte Globin (ATG)will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2, plus 6 doses of pegylated GCSF (6mg/dose)given subcutaneously every 2 weeks beginning after the ATG infusion"
894911|NCT01106092|B5|Baseline|Total|Total of all reporting groups
894912|NCT01106092|B4|Baseline|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894913|NCT01106092|B3|Baseline|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894914|NCT01106092|B2|Baseline|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894915|NCT01106092|B1|Baseline|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894916|NCT01106092|P4|Participant Flow|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894917|NCT01106092|P3|Participant Flow|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894918|NCT01106092|P2|Participant Flow|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894919|NCT01106092|P1|Participant Flow|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894920|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894921|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894922|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
895024|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
895025|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
894924|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894925|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894926|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894927|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894928|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894929|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894930|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894931|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894932|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894933|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894934|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894935|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894936|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894937|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894938|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894939|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894940|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894941|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894942|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894944|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894945|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894946|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894947|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894948|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894949|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894950|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894951|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894952|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894953|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894954|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894955|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894956|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894957|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894958|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894959|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894960|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894961|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894962|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894963|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894964|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894965|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894966|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894967|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894968|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894969|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894970|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894971|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894972|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894973|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894974|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894975|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894976|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894977|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894978|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894979|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894980|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894981|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894982|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894983|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894984|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894985|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894986|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894987|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894988|NCT01106092|O4|Outcome|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894989|NCT01106092|O3|Outcome|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894990|NCT01106092|O2|Outcome|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894991|NCT01106092|O1|Outcome|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894992|NCT01106092|E4|Reported Event|Zilbrix/Hib/Poliorix Group|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.
894993|NCT01106092|E3|Reported Event|GSK2036874A Group 3|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894994|NCT01106092|E2|Reported Event|GSK2036874A Group 2|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894995|NCT01106092|E1|Reported Event|GSK2036874A Group 1|Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
894996|NCT01106040|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
894997|NCT01106040|P1|Participant Flow|Lymphoseek, Lymphatic Mapping, Injection|Melanoma and breast cancer patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
894998|NCT01106040|O1|Outcome|Reverse Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
894999|NCT01106040|O1|Outcome|Intent-To-Treat|Participants received a single dose of 50 μg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m and blue dye for lymphatic mapping and surgical resection of lymph nodes.
895000|NCT01106040|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
895001|NCT01106014|B3|Baseline|Total|Total of all reporting groups
895002|NCT01106014|B2|Baseline|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
895003|NCT01106014|B1|Baseline|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
895004|NCT01106014|P2|Participant Flow|PLACEBO|Matching placebo was administered orally following the same administration schedule as described for selexipag
895005|NCT01106014|P1|Participant Flow|SELEXIPAG|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues.
895006|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
895007|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
895008|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
895009|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
895010|NCT01106014|O2|Outcome|Placebo|Matching placebo was administered orally following the same administration schedule as described for selexipag
895011|NCT01106014|O1|Outcome|Selexipag|During the 12-week titration phase, treatment was initiated at 200 μg twice daily (b.i.d.) and up-titrated weekly in 200 μg b.i.d. increments to the maximum tolerated dose (MTD) for each individual patient but not above 1600 μg b.i.d. At Week 12, patients continued the treatment at their individual MTD up to Week 26. Thereafter the dose could be up-titrated at scheduled visits if needed for patients receiving a dose &lt; 1600 μg b.i.d. The dose could be decreased at any time in case of tolerability issues
895012|NCT01106014|E2|Reported Event|Placebo|This group includes patients who received at least one dose of placebo. Four patients who were randomized to placebo never received the drugs and another patient received selexipag by mistake (see Selexipag group for more details). Therefore, these patients were excluded from the placebo group in the safety analysis set.
895013|NCT01106014|E1|Reported Event|Selexipag|This group includes patients who received at least one dose of selexipag. One subject who was randomized to placebo received a single dose of 8 tablets of selexipag due to an error in the dispensation of the medication bottle. Therefore, this patient was assigned to the selexipag group in the safety analysis set.
895014|NCT01105936|B1|Baseline|Total Participants for Baseline Measurement|All randomized participants except one were evaluated for baseline measures. One participant had misallocated treatments that could not be determined. Therefore, this participant was excluded from all populations including safety.
895015|NCT01105936|P4|Participant Flow|Sequence 4|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
895016|NCT01105936|P3|Participant Flow|Sequence 3|Participants took part in 3 study sessions. Session 1-no treatment was given. Session 2-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 3-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered.A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
895017|NCT01105936|P2|Participant Flow|Sequence 2|Participants took part in 3 study sessions. Session 1-participants took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
895018|NCT01105936|P1|Participant Flow|Sequence 1|Participants took part in 3 study sessions. Session 1-participant took two 665 mg sustained release paracetamol formulations orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. Session 2-no treatment was given. Session 3-participant took two caplets of matched placebo orally with 150 ml water. Four consecutive doses were administered every 8h, with the first dose (0h) and last dose (24h) under supervision at clinic and the second dose (8h) and third dose (16h) self-administered. A 5-14 day washout was given after session 1 and session 2. A 7-14 day follow-up was done after session 3.
895019|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
895020|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895021|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
895022|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
895023|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895029|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895030|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
895031|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
895032|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895033|NCT01105936|O1|Outcome|Paracetamol 665 Milligram (mg)|Participants took two 665 mg Paracetamol sustained release caplets orally with 150mL of water.
895034|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
895035|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895036|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
895037|NCT01105936|O3|Outcome|No Treatment|No treatment was given to participants.
895038|NCT01105936|O2|Outcome|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895039|NCT01105936|O1|Outcome|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
895040|NCT01105936|E3|Reported Event|No Treatment|No treatment was given to participants.
895041|NCT01105936|E2|Reported Event|Placebo|Participants took two placebo caplets to match Paracetamol sustained release caplets orally with 150 mL of water.
895042|NCT01105936|E1|Reported Event|Paracetamol 665 mg|Participants took two 665 mg Paracetamol sustained release caplets orally with 150 mL of water.
895043|NCT01105754|B3|Baseline|Total|Total of all reporting groups
895044|NCT01105754|B2|Baseline|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
895045|NCT01105754|B1|Baseline|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
895046|NCT01105754|P2|Participant Flow|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
895047|NCT01105754|P1|Participant Flow|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
895048|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
895049|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
895050|NCT01105754|O2|Outcome|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
895051|NCT01105754|O1|Outcome|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
895052|NCT01105754|E2|Reported Event|Intervention|"Multifaceted Prompting Intervention~Multifaceted Prompting Intervention MPI: Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
895053|NCT01105754|E1|Reported Event|Standard Care|Parents of children in the standard care group will complete the baseline assessment, but no asthma prompt will be created for either the caregiver or provider, and no information regarding the interview will be shared with the provider. After the baseline assessment, the office visit will proceed according to usual care.
895088|NCT01105533|P6|Participant Flow|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895584|NCT01104584|O1|Outcome|CMRM Versus UMRM|
895054|NCT01105702|B1|Baseline|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
895055|NCT01105702|P1|Participant Flow|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
895056|NCT01105702|O2|Outcome|Grade 4|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
895057|NCT01105702|O1|Outcome|Grade 3|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
895058|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
895059|NCT01105702|O1|Outcome|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
895060|NCT01105702|E1|Reported Event|TBL/RT|"Cycle 1(One 42-day cycle)~Temozolomide 75 mg/m^2 orally (42 consecutive days), beginning the night prior to the first radiation treatment~Radiation within 3-5 weeks of surgery~Bevacizumab 10mg/kg, IV, starting 29 (+3) days post surgery and every 2 weeks~Treatment Cycles 2-7 (28 days per cycle)~Temozolomide at a dose of 150 mg/m^2 on Days 1-7~Bevacizumab 10 mg/kg on Day 8 and Day 22~Initiate Lithium carbonate treatment at 300 mg, orally, twice a day; dose increased every 7 days up to 600mg, orally, twice a day, to a serum lithium level of 0.8-1.2 mEq/L."
895061|NCT01105650|B4|Baseline|Total|Total of all reporting groups
895062|NCT01105650|B3|Baseline|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
895063|NCT01105650|B2|Baseline|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
895064|NCT01105650|B1|Baseline|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
895065|NCT01105650|P4|Participant Flow|Arm 4: CsA/no Methylprednisolone/3 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin-2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 3 million units/m^2 3 times per week for 3 doses)."
895089|NCT01105533|P5|Participant Flow|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895090|NCT01105533|P4|Participant Flow|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895066|NCT01105650|P3|Participant Flow|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
895067|NCT01105650|P2|Participant Flow|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
895068|NCT01105650|P1|Participant Flow|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
895069|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
895070|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
895071|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
895072|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
895073|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
895074|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
895091|NCT01105533|P3|Participant Flow|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895092|NCT01105533|P2|Participant Flow|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895093|NCT01105533|P1|Participant Flow|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895094|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
899005|NCT01091103|O1|Outcome|Enzalutamide|
895075|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
895076|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
895077|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
895078|NCT01105650|O3|Outcome|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
895079|NCT01105650|O2|Outcome|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
895080|NCT01105650|O1|Outcome|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
895081|NCT01105650|E3|Reported Event|Arm 3: CsA/Methylprednisolone (1mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA ): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously, 1 mg/kg Days -2 to +9"
895082|NCT01105650|E2|Reported Event|Arm 2: CsA/Methylprednisolone (10mg)/6 Doses of Interleukin-2|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses).~Methylprednisolone: Administered intravenously,10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9."
895083|NCT01105650|E1|Reported Event|Arm 1: CsA|"Fludarabine: Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).~Cyclophosphamide: Administered intravenously, 60 mg/kg, days -5 and -4.~Cyclosporine (CsA): Administered intravenously, 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14~Natural Killer cells: Administered by infusion over less than 1 hour; no more than 8.0 x 10^7 cells/kg will be given.~Interleukin- 2 (IL-2): Given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, IL-2 will be given at 5 million units/m^2 3 times per week for 6 doses)."
895084|NCT01105533|B1|Baseline|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
895085|NCT01105533|P9|Participant Flow|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895086|NCT01105533|P8|Participant Flow|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895087|NCT01105533|P7|Participant Flow|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895097|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895098|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895099|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895100|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895101|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895102|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895103|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895104|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895105|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895106|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895107|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895108|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895109|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895110|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895111|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895112|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
895113|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895114|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895115|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895116|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895117|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895118|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895119|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895120|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895121|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895122|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895123|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895124|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895125|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895126|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895127|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895128|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895129|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895130|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895131|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895132|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895133|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895134|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895135|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895136|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895137|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895138|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895139|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895140|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895141|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895142|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895143|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895144|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895145|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895146|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895147|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895148|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895149|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895150|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895151|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895152|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895153|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895154|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895155|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895156|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895157|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895158|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895159|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895160|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895161|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895162|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895163|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895164|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895165|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895166|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895167|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
895168|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
895169|NCT01105533|O1|Outcome|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
895170|NCT01105533|O9|Outcome|PF-00337210 6 mg Twice Daily|PF-00337210 6 mg capsule orally twice daily in cycles of 28 days.
895171|NCT01105533|O8|Outcome|PF-00337210 4 mg Twice Daily|PF-00337210 4 mg capsule orally twice daily in cycles of 28 days.
895172|NCT01105533|O7|Outcome|PF-00337210 9 mg Once Daily|PF-00337210 9 mg capsule orally once daily in cycles of 28 days.
895173|NCT01105533|O6|Outcome|PF-00337210 8 mg Once Daily|PF-00337210 8 mg capsule orally once daily in cycles of 28 days.
895174|NCT01105533|O5|Outcome|PF-00337210 6 mg Once Daily|PF-00337210 6 mg capsule orally once daily in cycles of 28 days.
895175|NCT01105533|O4|Outcome|PF-00337210 4 mg Once Daily|PF-00337210 4 mg capsule orally once daily in cycles of 28 days.
895176|NCT01105533|O3|Outcome|PF-00337210 2 mg Once Daily|PF-00337210 2 mg capsule orally once daily in cycles of 28 days.
895177|NCT01105533|O2|Outcome|PF-00337210 1 mg Once Daily|PF-00337210 1 mg capsule orally once daily in cycles of 28 days.
895178|NCT01105533|O1|Outcome|PF-00337210 0.67 mg Once Daily|PF-00337210 0.67 milligram (mg) capsule orally once daily in cycles of 28 days.
895179|NCT01105533|E1|Reported Event|PF-00337210|PF-00337210 0.67 mg, 1 mg, 2 mg, 4 mg, 6 mg, 8 mg or 9 mg capsule orally once daily or PF-00337210 4 mg or 6 mg capsule twice daily in cycles of 28 days.
895180|NCT01105377|B3|Baseline|Total|Total of all reporting groups
895181|NCT01105377|B2|Baseline|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
895182|NCT01105377|B1|Baseline|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
895183|NCT01105377|P2|Participant Flow|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
895184|NCT01105377|P1|Participant Flow|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
895185|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
895223|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
895279|NCT01103973|O1|Outcome|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
895186|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
895187|NCT01105377|O2|Outcome|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
895188|NCT01105377|O1|Outcome|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
895189|NCT01105377|E2|Reported Event|Cohort II|Treatment After Eligibility Criteria Amendment: Participants 25-47 were registered according to the eligibility requirements detailed in the Eligibility Criteria section of this report for Cohort II, which contains more restrictive criteria than Cohort I. Study treatment remained the same as Cohort I. Participants receive 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
895190|NCT01105377|E1|Reported Event|Cohort I|Treatment Prior to Eligibility Criteria Amendment: Participants 1-24 were registered according to the Eligibility Criteria for Cohort I detailed in this report. Participants received 40 mg/m^2 azacitidine subcutaneously on days 1-5 and 8-10 and 7 mg oral entinostat on days 3 and 10. Courses repeat every 28 days until disease progression or unacceptable toxicity.
895191|NCT01105247|B3|Baseline|Total|Total of all reporting groups
895192|NCT01105247|B2|Baseline|Food Effect Cohort|PCI-32765: 420 mg daily
895193|NCT01105247|B1|Baseline|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
895194|NCT01105247|P2|Participant Flow|Food Effect Cohort|PCI-32765: 420 mg daily
895195|NCT01105247|P1|Participant Flow|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily.
895196|NCT01105247|O3|Outcome|Food Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
895197|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
895198|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
895199|NCT01105247|O3|Outcome|Food- Effect|Food-Effect Relapsed/refractory participants received PCI-32765 420 mg daily
895200|NCT01105247|O2|Outcome|Relapsed/ Refractory|PCI-32765: 420 mg daily or 840 mg daily
895201|NCT01105247|O1|Outcome|Treatment Naive|PCI-32765: 420 mg daily or 840 mg daily
895202|NCT01105247|O1|Outcome|Food Effect Cohort|PCI-32765: 420 mg daily
895203|NCT01105247|O2|Outcome|Food Effect|Food-Effect Relapsed/Refractory participants received PCI-32765 420 mg daily
895204|NCT01105247|O1|Outcome|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
895205|NCT01105247|E2|Reported Event|Food Effect|PCI-32765: 420 mg daily
895206|NCT01105247|E1|Reported Event|PCI-32765|PCI-32765: 420 mg daily or 840 mg daily
895207|NCT01105130|B4|Baseline|Total|Total of all reporting groups
895208|NCT01105130|B3|Baseline|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
895209|NCT01105130|B2|Baseline|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
895210|NCT01105130|B1|Baseline|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
895211|NCT01105130|P3|Participant Flow|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
895212|NCT01105130|P2|Participant Flow|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
895213|NCT01105130|P1|Participant Flow|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
895214|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
895215|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
895216|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
895217|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
895218|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
895219|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
895220|NCT01105130|O3|Outcome|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
895221|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
895222|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
895224|NCT01105130|O2|Outcome|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
895225|NCT01105130|O1|Outcome|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
895226|NCT01105130|E3|Reported Event|Arm III - High Dose|"Oral L-arginine twice daily = 6 capsules per day.~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules~Oral L-Arginine: Patients will take 6 capsules of ArginMax twice daily"
895227|NCT01105130|E2|Reported Event|Arm II - Low Dose|"Patients receive oral L-arginine and oral placebo twice daily (total of 3 capsules of each per day).~Placebo: Given orally~Oral L-Arginine: Given orally 3 capsules ArginMax and 3 Placebo capsules"
895228|NCT01105130|E1|Reported Event|Arm I - Placebo|"Patients receive oral placebo twice daily (total of 6 capsules per day).~Placebo: Given orally"
895229|NCT01105117|B3|Baseline|Total|Total of all reporting groups
895230|NCT01105117|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
895231|NCT01105117|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
895232|NCT01105117|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
895233|NCT01105117|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
895234|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
895235|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
895236|NCT01105117|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
895237|NCT01105117|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
895238|NCT01105117|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|"Flolan®~Flolan® : per Prescribing Information"
895239|NCT01105117|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|"ACT-385781A (Actelion Epoprostenol)~ACT-385781A (Actelion Epoprostenol) : per Prescribing Information"
895240|NCT01105091|B3|Baseline|Total|Total of all reporting groups
895241|NCT01105091|B2|Baseline|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895242|NCT01105091|B1|Baseline|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895243|NCT01105091|P2|Participant Flow|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895244|NCT01105091|P1|Participant Flow|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895245|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895246|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895247|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895248|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895249|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895250|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895251|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895252|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895253|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895254|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895255|NCT01105091|O2|Outcome|Flolan (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895256|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895257|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895258|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895259|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895260|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895261|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895262|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895263|NCT01105091|O2|Outcome|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895264|NCT01105091|O1|Outcome|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895265|NCT01105091|E2|Reported Event|Flolan® (Epoprostenol Sodium) for Injection|The prepared solution was administered by continuous i.v. infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability
895266|NCT01105091|E1|Reported Event|ACT-385781A (Epoprostenol for Injection)|The prepared solution was administered by continuous intravenous (i.v.) infusion via a central venous catheter using an ambulatory infusion pump. Administration was to be initiated at an infusion rate of 2 ng/kg/min, with up titration according to therapeutic need and tolerability.
895267|NCT01105065|B1|Baseline|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
895268|NCT01105065|P1|Participant Flow|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
895269|NCT01105065|O2|Outcome|RVD Patients Post-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients after their treatment with brimonidine.
895270|NCT01105065|O1|Outcome|RVD Patients Pre-brimonidine Treatment|Patients who exhibited retinal vascular dysregulation at the initial visit. The mean deviation frequency doubling perimetry values were measured in these patients before their treatment with brimonidine.
895271|NCT01105065|O1|Outcome|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
895272|NCT01105065|E1|Reported Event|Patients With RVD|"Patients who exhibited retinal vascular dysregulation at the initial visit. Intervention: brimonidine 0.15% three times per day for 8 weeks.~Alphagan (brimonidine) 0.15%: One drop in each eye three times a day for 8 weeks."
895273|NCT01103973|B3|Baseline|Total|Total of all reporting groups
895274|NCT01103973|B2|Baseline|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
895275|NCT01103973|B1|Baseline|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
895276|NCT01103973|P2|Participant Flow|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
895277|NCT01103973|P1|Participant Flow|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
895278|NCT01103973|O2|Outcome|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
895280|NCT01103973|E2|Reported Event|Mind/Body Program|"Ten week group mind/body program. Skills include relaxation training, cognitive strategies, and lifestyle modifications.~Mind/Body Program: Ten week group mind/body program"
895281|NCT01103973|E1|Reported Event|Control (Spa Certificate)|"For every three months in the study control subjects received $50 spa gift certificates.~Control: Spa gift certificates"
895282|NCT01103960|B3|Baseline|Total|Total of all reporting groups
895283|NCT01103960|B2|Baseline|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895284|NCT01103960|B1|Baseline|A5 Alone|Amlodipine 5mg monotherapy
895285|NCT01103960|P2|Participant Flow|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895286|NCT01103960|P1|Participant Flow|A5 Alone|Amlodipine 5mg monotherapy
895287|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895288|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895289|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895290|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895291|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895292|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895293|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895294|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895295|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895296|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895297|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895298|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895299|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895300|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895301|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895302|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895303|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895304|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895305|NCT01103960|O2|Outcome|T80/A5|Telmisartan 80mg plus Amlodipine 5mg fixed-dose combination
895306|NCT01103960|O1|Outcome|A5 Alone|Amlodipine 5mg monotherapy
895307|NCT01103960|E2|Reported Event|T80/A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily
895308|NCT01103960|E1|Reported Event|A5 Alone|Amlodipine 5 mg one daily
895309|NCT01103934|B3|Baseline|Total|Total of all reporting groups
895310|NCT01103934|B2|Baseline|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895311|NCT01103934|B1|Baseline|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895312|NCT01103934|P2|Participant Flow|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895313|NCT01103934|P1|Participant Flow|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895314|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895315|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895316|NCT01103934|O2|Outcome|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895317|NCT01103934|O1|Outcome|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895318|NCT01103934|E2|Reported Event|Fluticasone Propionate Plus Placebo|"Subjects will be treated with fluticasone propionate and placebo for Vitamin D once daily for 2 weeks during allergy season~Placebo: Placebo taken once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895319|NCT01103934|E1|Reported Event|Fluticasone Propionate Plus Vitamin D3|"Subjects will be treated with fluticasone propionate and Vitamin D once daily for 2 weeks during allergy season~Vitamin D3: 4000 IU once daily~Fluticasone Propionate: 200 mcg daily, intranasal"
895320|NCT01102803|B3|Baseline|Total|Total of all reporting groups
895321|NCT01102803|B2|Baseline|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
895322|NCT01102803|B1|Baseline|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
895323|NCT01102803|P2|Participant Flow|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
895324|NCT01102803|P1|Participant Flow|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
895325|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
895326|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
895327|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
895328|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
895329|NCT01102803|O2|Outcome|D-Cycloserine|Participants will receive D-Cycloserine (50mg) augmented cognitive behavioral therapy
895825|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895330|NCT01102803|O1|Outcome|Sugar Pill|Participants will receive sugar pill placebo augmented cognitive behavioral therapy
895331|NCT01102803|O2|Outcome|Placebo+CBT Treatment|Participants receiving PL augmented CBT
895332|NCT01102803|O1|Outcome|DCS+CBT Treatment|Participants receiving DCS augmented CBT
895333|NCT01102803|E2|Reported Event|Pill Placebo + CBT|CBT augmented with sugar pill placebo
895334|NCT01102803|E1|Reported Event|DCS+CBT|CBT augmented with DCS (50mg)
895335|NCT01102777|B3|Baseline|Total|Total of all reporting groups
895336|NCT01102777|B2|Baseline|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895337|NCT01102777|B1|Baseline|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895338|NCT01102777|P2|Participant Flow|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895339|NCT01102777|P1|Participant Flow|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895340|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895341|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895342|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895343|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895344|NCT01102777|O2|Outcome|Intervention|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895345|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895346|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895347|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895348|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895349|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895350|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895351|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895352|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895353|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895354|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895355|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895410|NCT01104701|B4|Baseline|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
895356|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895357|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895358|NCT01102777|O2|Outcome|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895359|NCT01102777|O1|Outcome|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895360|NCT01102777|E2|Reported Event|Internet-mediated Walking Program|"participants in the intervention arm are asked to participate in a walking program~automated internet-mediated walking program: intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress"
895361|NCT01102777|E1|Reported Event|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
895362|NCT01102764|B3|Baseline|Total|Total of all reporting groups
895363|NCT01102764|B2|Baseline|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
895364|NCT01102764|B1|Baseline|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
895365|NCT01102764|P2|Participant Flow|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
895366|NCT01102764|P1|Participant Flow|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
895367|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
895368|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
895369|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
895370|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
895371|NCT01102764|O2|Outcome|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
895372|NCT01102764|O1|Outcome|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
895373|NCT01102764|E2|Reported Event|Arm 2: PE in Person|"PE in person~In Person: PE therapy delivered in person at the VAMC"
895374|NCT01102764|E1|Reported Event|Arm 1: PE Via Telemedicine|"PE via telemedicine~Telemedicine: Prolonged Exposure (PE) therapy provided at patients house via telemedicine"
895375|NCT01104870|B4|Baseline|Total|Total of all reporting groups
895376|NCT01104870|B3|Baseline|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895377|NCT01104870|B2|Baseline|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895378|NCT01104870|B1|Baseline|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895379|NCT01104870|P3|Participant Flow|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895380|NCT01104870|P2|Participant Flow|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895381|NCT01104870|P1|Participant Flow|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895382|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895383|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895384|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895385|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895386|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895387|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895388|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895389|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895390|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895391|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895392|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895393|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895394|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895395|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895396|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895397|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895398|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895399|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895400|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895401|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895402|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895403|NCT01104870|O3|Outcome|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895404|NCT01104870|O2|Outcome|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895405|NCT01104870|O1|Outcome|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895406|NCT01104870|E3|Reported Event|Dose Group 3|"individual Maximum Tolerated Dose~UT-15C: oral"
895407|NCT01104870|E2|Reported Event|Dose Group 2|"1.25 mg twice daily~UT-15C: oral"
895408|NCT01104870|E1|Reported Event|Dose Group 1|"0.25 mg twice daily~UT-15C: oral"
895411|NCT01104701|B3|Baseline|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
895412|NCT01104701|B2|Baseline|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
895413|NCT01104701|B1|Baseline|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
895414|NCT01104701|P4|Participant Flow|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895415|NCT01104701|P3|Participant Flow|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895416|NCT01104701|P2|Participant Flow|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895417|NCT01104701|P1|Participant Flow|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895418|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895419|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895420|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895421|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895422|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895423|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895424|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895425|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895426|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895427|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895428|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895429|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895430|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895431|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895432|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895433|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895434|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895435|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895436|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895437|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895438|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895439|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895440|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895441|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895442|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895443|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895444|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895445|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895446|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895447|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895448|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895449|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895450|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895451|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895452|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895453|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895454|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895455|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895456|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895457|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895458|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895459|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895460|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895461|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895462|NCT01104701|O4|Outcome|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895463|NCT01104701|O3|Outcome|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides. .
895464|NCT01104701|O2|Outcome|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC over 20 weeks. Miglyol is a clear oil mixture of medium chain triglycerides.
895465|NCT01104701|O1|Outcome|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC) over 20 weeks.
895466|NCT01104701|E4|Reported Event|11 mg Exenatide Monthly|11 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
895467|NCT01104701|E3|Reported Event|8 mg Exenatide Monthly|8 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides. .
895468|NCT01104701|E2|Reported Event|5 mg Exenatide Monthly|5 mg exenatide microspheres in Miglyol 812 were administered once a month SC. Miglyol is a clear oil mixture of medium chain triglycerides.
895469|NCT01104701|E1|Reported Event|2 mg Exenatide Weekly|2 milligrams (mg) exenatide microspheres in aqueous diluent were administered once a week as a subcutaneous injection (SC).
895470|NCT01104662|B9|Baseline|Total|Total of all reporting groups
895471|NCT01104662|B8|Baseline|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895472|NCT01104662|B7|Baseline|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895603|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895823|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895824|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
917351|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
895473|NCT01104662|B6|Baseline|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895474|NCT01104662|B5|Baseline|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895475|NCT01104662|B4|Baseline|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895476|NCT01104662|B3|Baseline|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
895477|NCT01104662|B2|Baseline|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895478|NCT01104662|B1|Baseline|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
895479|NCT01104662|P8|Participant Flow|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895480|NCT01104662|P7|Participant Flow|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895481|NCT01104662|P6|Participant Flow|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895482|NCT01104662|P5|Participant Flow|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For complicated skin and skin structure infections (cSSSI) participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895494|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
899006|NCT01091103|O1|Outcome|Enzalutamide|
895483|NCT01104662|P4|Participant Flow|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895484|NCT01104662|P3|Participant Flow|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
895485|NCT01104662|P2|Participant Flow|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin/semi-synthetic penicillin (SSP; for example, nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895486|NCT01104662|P1|Participant Flow|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
895487|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895488|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895489|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895490|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895491|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895492|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion
895493|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895495|NCT01104662|O8|Outcome|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895496|NCT01104662|O7|Outcome|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895497|NCT01104662|O6|Outcome|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895498|NCT01104662|O5|Outcome|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895499|NCT01104662|O4|Outcome|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895500|NCT01104662|O3|Outcome|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
895501|NCT01104662|O2|Outcome|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895502|NCT01104662|O1|Outcome|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.
895503|NCT01104662|E8|Reported Event|Vancomycin or SSP, cSSSI, Moderate Renal Impairment|Cohort 4. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895504|NCT01104662|E7|Reported Event|Daptomycin, cSSSI, Moderate Renal Impairment|Cohort 4. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895505|NCT01104662|E6|Reported Event|Vancomycin or SSP, cSSSI, Severe Renal Impairment|Cohort 3. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for cSSSI or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895523|NCT01104584|O1|Outcome|CMRM Versus UMRM|
895506|NCT01104662|E5|Reported Event|Daptomycin, cSSSI, Severe Renal Impairment|Cohort 3. Daptomycin was given intravenously 4 milligrams per kilogram (mg/kg) per administration. For cSSSI participants with CLcr below 30 mL/min and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 7 to 14 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 7 to 14 days based on disease resolution or Investigator discretion.
895507|NCT01104662|E4|Reported Event|Vancomycin or SSP, Bacteremia, Moderate Renal Impairment|Cohort 2. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by MSSA could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered IV until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895508|NCT01104662|E3|Reported Event|Daptomycin, Bacteremia, Moderate Renal Impairment|Cohort 2. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with CLcr values between 30 and 50 mL/min not receiving dialysis, daptomycin was administered every 24 hours for 14 to 42 days based on disease resolution or Investigator discretion.
895509|NCT01104662|E2|Reported Event|Vancomycin or SSP, Bacteremia, Severe Renal Impairment|Cohort 1. Participants randomized to the comparator therapy group received vancomycin or penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin). Investigators were allowed to select an agent based on local availability and normal treatment practices. Participants randomized to comparator subsequently found to have an infection caused by Methicillin-Susceptible Staphylococcus Aureus (MSSA) could have switched from vancomycin to penicillinase-resistant penicillin (nafcillin, oxacillin, or cloxacillin) at the Investigator’s discretion. All treatments were dosed per Investigator’s discretion and were administered intravenously until end of antibiotic therapy for bacteremia or until hospital discharge, whichever occurred first. Investigators treated participants according to their usual decision-making and discretion.
895510|NCT01104662|E1|Reported Event|Daptomycin, Bacteremia, Severe Renal Impairment|Cohort 1. Daptomycin was given intravenously 6 milligrams per kilogram (mg/kg) per administration. For bacteremia participants with Creatinine Clearance (CLcr) below 30 milliliters per minute (mL/min) and currently receiving hemodialysis, daptomycin was administered immediately following each hemodialysis session (3 per week) for 14 to 42 days based on disease resolution or Investigator discretion. For participants not receiving dialysis, daptomycin was administered every 48 hours for 14 to 42 days based on disease resolution or Investigator discretion.)
895511|NCT01104636|B1|Baseline|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
895512|NCT01104636|P1|Participant Flow|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
895513|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
895514|NCT01104636|O1|Outcome|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
895515|NCT01104636|E1|Reported Event|Varenicline|Varenicline tartrate tablet was prescribed for 12 weeks as per the approved Summary of Product Characteristics (SmPC) and was adjusted according to medical and therapeutic necessity.
895516|NCT01104584|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
895517|NCT01104584|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
895518|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
895519|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
895520|NCT01104584|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Patients first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
895521|NCT01104584|O3|Outcome|CMRM+XRM vs XRM|
895522|NCT01104584|O2|Outcome|CMRM+XRM vs UMRM+XRM|
895585|NCT01104584|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
895586|NCT01104558|B1|Baseline|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895587|NCT01104558|P1|Participant Flow|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895588|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895589|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895590|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895591|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895592|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895593|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895594|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895595|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895596|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895597|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895598|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895599|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895600|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895601|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895602|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
899007|NCT01091103|O1|Outcome|Enzalutamide|
895604|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895605|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895606|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895607|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895608|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895609|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895610|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895611|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895612|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895613|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895614|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895615|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895616|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895617|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895618|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895619|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895620|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895621|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895667|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
895622|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895623|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895624|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895625|NCT01104558|O1|Outcome|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895626|NCT01104558|E1|Reported Event|Bisoprolol|Bisoprolol tablet administered at a starting dose of 1.25 milligram (mg) once daily (OD) for two weeks and if it was well tolerated, the dose was increased to 2.5 mg , 3.75 mg, 5 mg OD in intervals of two weeks, 5 mg OD as a maintenance therapy, for a total time period of 26 weeks. If it was well tolerated, the dose was increased to a maximum of 10 mg/day.
895627|NCT01104493|B3|Baseline|Total|Total of all reporting groups
895628|NCT01104493|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895629|NCT01104493|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895630|NCT01104493|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895631|NCT01104493|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895632|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895633|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895634|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895635|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895636|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895637|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895638|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895639|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895640|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895641|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895642|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895666|NCT01104311|O1|Outcome|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
895643|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895644|NCT01104493|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895645|NCT01104493|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895646|NCT01104493|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1.
895647|NCT01104493|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1.
895648|NCT01104376|B1|Baseline|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
895649|NCT01104376|P1|Participant Flow|CYP2B6 Activity|"CYP2B6 activity was measured using efavirenz metabolism and pharmacokinetics at baseline and after pretreatment with voriconazole.~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.~In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
895650|NCT01104376|O1|Outcome|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
895651|NCT01104376|E1|Reported Event|CYP2B6|"Healthy volunteers will receive Efavirenz and Vericonazole as follow:~In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered. In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
895652|NCT01104311|B3|Baseline|Total|Total of all reporting groups
895653|NCT01104311|B2|Baseline|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
895654|NCT01104311|B1|Baseline|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
895655|NCT01104311|P2|Participant Flow|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
895656|NCT01104311|P1|Participant Flow|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
895657|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
895658|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
895659|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
895660|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
895661|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
895662|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
895663|NCT01104311|O2|Outcome|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs"
895664|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
895665|NCT01104311|O2|Outcome|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
895668|NCT01104311|O1|Outcome|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level"
895669|NCT01104311|O2|Outcome|Modest BP Lowering|Lowering of systolic blood pressure between 130mmHg and 140mmHg modest blood pressure lowering: adjust the amount and number of antihypertensive drugs
895670|NCT01104311|O1|Outcome|Aggressive BP Lowering|Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
895671|NCT01104311|E2|Reported Event|Modest BP Lowering|"Lowering of systolic blood pressure between 130mmHg and 140mmHg~modest blood pressure lowering: adjust the amount and number of antihypertensive drugs (Safety population: 65)"
895672|NCT01104311|E1|Reported Event|Aggressive BP Lowering|"Lowering of systolic blood pressure between 110mmHg and 120mmHg during study period~Aggressive BP lowering: adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level (Safety population: 65)"
895673|NCT01104285|B3|Baseline|Total|Total of all reporting groups
895674|NCT01104285|B2|Baseline|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
895675|NCT01104285|B1|Baseline|Standard Care|Treatment of pleural effusion with diuresis
895676|NCT01104285|P2|Participant Flow|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
895677|NCT01104285|P1|Participant Flow|Standard Care|Treatment of pleural effusion with diuresis
895678|NCT01104285|O2|Outcome|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
895679|NCT01104285|O1|Outcome|Standard Care|Treatment of pleural effusion with diuresis
895680|NCT01104285|E2|Reported Event|Chest Tube|Treatment of pleural effusion with diuresis and chest tube
895681|NCT01104285|E1|Reported Event|Standard Care|Treatment of pleural effusion with diuresis
895682|NCT01104246|B1|Baseline|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
895683|NCT01104246|P1|Participant Flow|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
895684|NCT01104246|O1|Outcome|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
895685|NCT01104246|E1|Reported Event|Testosterone Transdermal Systems|Testosterone Transdermal System was applied daily starting at 4 mg, titratable to 6 mg or 2 mg based on testosterone serum concentration.
895686|NCT01104207|B3|Baseline|Total|Total of all reporting groups
895687|NCT01104207|B2|Baseline|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
895688|NCT01104207|B1|Baseline|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
895689|NCT01104207|P2|Participant Flow|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
895690|NCT01104207|P1|Participant Flow|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
895691|NCT01104207|O2|Outcome|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
895692|NCT01104207|O1|Outcome|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
895693|NCT01104207|E2|Reported Event|Arm 2|"For half of the subjects, placebo rTMS will be delivered to one side of the head.~placebo rTMS: placebo rTMS"
895694|NCT01104207|E1|Reported Event|Arm 1|"For half of the subjects, rTMS will be delivered to one side of the head.~repetitive transcranial magnetic stimulation (rTMS): rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception."
895695|NCT01104155|B3|Baseline|Total|Total of all reporting groups
895696|NCT01104155|B2|Baseline|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
895697|NCT01104155|B1|Baseline|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
895698|NCT01104155|P2|Participant Flow|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
895699|NCT01104155|P1|Participant Flow|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
895700|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
895701|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
895702|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
895703|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
895704|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
895705|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
895706|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
895707|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
895708|NCT01104155|O2|Outcome|Eribulin Mesylate Plus Erlotinib, 28 Day Regimen|Eribulin mesylate was given at a dose of 1.4 mg/m^2 as a 2 to 5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15 to 28 of a 28-day cycle.
895709|NCT01104155|O1|Outcome|Eribulin Mesylate Plus Erlotinib, 21 Day Regimen|Eribulin mesylate was given at a dose of 2 mg/m^2 as a 2 to 5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib was given orally once daily, one hour before or two hours after the ingestion of food, on Days 2 to 16 of a 21-day cycle.
895710|NCT01104155|E2|Reported Event|Eribulin Mesylate, 28 Day Cycle|eribulin mesylate + erlotinib: 28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
895711|NCT01104155|E1|Reported Event|Eribulin Mesylate, 21 Day Cycle|eribulin mesylate + erlotinib: 21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
895712|NCT01104116|B1|Baseline|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
895713|NCT01104116|P1|Participant Flow|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
895714|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
895715|NCT01104116|O1|Outcome|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
895716|NCT01104116|E1|Reported Event|PET/CT Imaging|"Surgical patients will undergo [18F]-FDG PET/CT imaging~[18F]-FDG PET/CT imaging: Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)"
895717|NCT01104103|B3|Baseline|Total|Total of all reporting groups
895718|NCT01104103|B2|Baseline|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
895719|NCT01104103|B1|Baseline|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
895720|NCT01104103|P2|Participant Flow|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
895721|NCT01104103|P1|Participant Flow|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
895722|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
895723|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
895724|NCT01104103|O2|Outcome|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
895725|NCT01104103|O1|Outcome|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
895726|NCT01104103|E2|Reported Event|Standard Care|Nurse or paramedic uses standard IV starting technique in the upper extremity of adults
895727|NCT01104103|E1|Reported Event|BOA(R)|Nurse or paramedic uses the BOA(R)-Constricting IV Band to attempt placement of an upper extremity IV in an adult
895728|NCT01103713|B1|Baseline|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
895729|NCT01103713|P1|Participant Flow|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
895730|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895754|NCT01103492|B1|Baseline|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
895731|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895732|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895733|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895734|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895735|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895736|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895737|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895738|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895739|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895740|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895741|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895742|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895743|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895744|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895745|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895746|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895747|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895748|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2)
895749|NCT01103713|O1|Outcome|Azithromycin/Chloroquine (AZCQ)|This is an open label, single arm study conducted in pregnant women during their second and third trimesters of pregnancy. Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
895750|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
895751|NCT01103713|O1|Outcome|Azithromycin (AZ)/Chloroquine (CQ)|Study drug AZCQ is a fixed dose combination tablet of AZ and CQ containing 250 mg AZ and 155 mg CQ base. The dosing regimen evaluated in this study consisted of four AZCQ tablets (a total of 1000 mg AZ/620 mg CQ base), given orally once daily for 3 days (Days 0, 1, 2).
895752|NCT01103713|E2|Reported Event|Azithromycin/Chloroquine (Familial Status = Mother)|ACZQ (Familial Status = Mother)
895753|NCT01103713|E1|Reported Event|Azithromycin/Chloroquine (Familial Status = Neonate)|AZCQ (Familial Status = Neonate)
895755|NCT01103492|P1|Participant Flow|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
895756|NCT01103492|O1|Outcome|Ablation Treatment|Subjects with radiation proctitis who met inclusion criteria
895757|NCT01103492|E1|Reported Event|Ablation Catheter|Procedure using the HALO90 Ablation catheter to heat a thin layer of rectal tissue using radiofrequency to reduce inflammation and bleeding in subjects with radiation proctitis.
895758|NCT01103479|B4|Baseline|Total|Total of all reporting groups
895759|NCT01103479|B3|Baseline|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
895760|NCT01103479|B2|Baseline|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
895761|NCT01103479|B1|Baseline|Control|Participants will complete interviewer-administered pre- and post-test
895762|NCT01103479|P3|Participant Flow|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
895763|NCT01103479|P2|Participant Flow|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
895764|NCT01103479|P1|Participant Flow|Control|Participants will complete interviewer-administered pre- and post-test
895765|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
895766|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
895767|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training~Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
895768|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
895769|NCT01103479|O2|Outcome|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
895770|NCT01103479|O1|Outcome|Physician Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
895818|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895819|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895820|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895821|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895822|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895771|NCT01103479|O2|Outcome|Intervention|"Participants in either the Physician Intervention or Physician and Patient Intervention Arms.~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training~Physician and Patient Intervention: Physician intervention as described plus patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this co"
895772|NCT01103479|O1|Outcome|Control|Participants will complete interviewer-administered pre- and post-test
895773|NCT01103479|E3|Reported Event|Physician and Patient Intervention|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational digital video disc (DVD) on CRC and CRC screening~Physician and Patient Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening"
895774|NCT01103479|E2|Reported Event|Physician Training|"Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer screening guidelines, communication skills, and health literacy training~Physician Intervention: Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training"
895775|NCT01103479|E1|Reported Event|Control|Participants will complete interviewer-administered pre- and post-test
895776|NCT01103466|B1|Baseline|All Study Parcipitants|All parcipitants recieved all three intervention and they are therefore combined into one group.
895777|NCT01103466|P3|Participant Flow|Conform2|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
895778|NCT01103466|P2|Participant Flow|SenSura|"Commercially available base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
895779|NCT01103466|P1|Participant Flow|Atlas|"New base plate~All subjects tested this test product in one period during the study.~No parcipitants recieved the same study intervention more than once"
895780|NCT01103466|O3|Outcome|Conform2|base plate
895781|NCT01103466|O2|Outcome|SenSura|base plate
895782|NCT01103466|O1|Outcome|Atlas|new base plate
895783|NCT01103466|E3|Reported Event|Conform2|base plate
895784|NCT01103466|E2|Reported Event|SenSura|base plate
895785|NCT01103466|E1|Reported Event|Atlas|new base plate
895786|NCT01103414|B6|Baseline|Total|Total of all reporting groups
895787|NCT01103414|B5|Baseline|Matching Placebo|Over-encapsulated placebo tablet
895788|NCT01103414|B4|Baseline|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895789|NCT01103414|B3|Baseline|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895790|NCT01103414|B2|Baseline|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895791|NCT01103414|B1|Baseline|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895792|NCT01103414|P5|Participant Flow|Matching Placebo|Over-encapsulated placebo tablet
895793|NCT01103414|P4|Participant Flow|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895794|NCT01103414|P3|Participant Flow|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895795|NCT01103414|P2|Participant Flow|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895796|NCT01103414|P1|Participant Flow|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895797|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895798|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895799|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895800|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895801|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895802|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895803|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895804|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895805|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895806|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895807|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895808|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895809|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895810|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895811|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895812|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895813|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895814|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895815|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895816|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895817|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895826|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895827|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895828|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895829|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895830|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895831|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895832|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895833|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895834|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895835|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895836|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895837|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895838|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895839|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895840|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895841|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895842|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895843|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895844|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895845|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895846|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895847|NCT01103414|O5|Outcome|Matching Placebo|Over-encapsulated placebo tablet
895848|NCT01103414|O4|Outcome|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895849|NCT01103414|O3|Outcome|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895850|NCT01103414|O2|Outcome|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895851|NCT01103414|O1|Outcome|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895852|NCT01103414|E5|Reported Event|Matching Placebo|Over-encapsulated placebo tablet
895853|NCT01103414|E4|Reported Event|Pioglitazone 45 mg Capsules|Over-encapsulated ACTOS three 15 mg tablets
895854|NCT01103414|E3|Reported Event|Mitoglitazone 150 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet and 100 mg tablet
895855|NCT01103414|E2|Reported Event|Mitoglitazone 100 mg Capsules|Over-encapsulated Mitoglitazone 100 mg tablet
895856|NCT01103414|E1|Reported Event|Mitoglitazone 50 mg Capsules|Over-encapsulated Mitoglitazone 50 mg tablet
895857|NCT01103362|B1|Baseline|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
895858|NCT01103362|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
895859|NCT01103362|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
895860|NCT01103362|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: all patients will receive open-label flibanserin 100mg"
895861|NCT01103323|B3|Baseline|Total|Total of all reporting groups
895862|NCT01103323|B2|Baseline|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895863|NCT01103323|B1|Baseline|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895864|NCT01103323|P2|Participant Flow|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). Period 1 is placebo and placebo-regorafenib with placebo period only before unblinding. Period 2 is placebo-regorafenib with regorafenib period only.
895865|NCT01103323|P1|Participant Flow|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895866|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
895867|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895868|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
895869|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895870|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
895871|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895872|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
895873|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895874|NCT01103323|O2|Outcome|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC)
917352|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
895875|NCT01103323|O1|Outcome|Regorafenib (Stivarga, BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895876|NCT01103323|E3|Reported Event|Placebo - Regorafenib After Unblinding|Participants in the placebo+BSC group switched to treatment with Regorafenib after unblinding. It is for Regorafenib treatment period only
895877|NCT01103323|E2|Reported Event|Placebo+BSC|Participants received matching placebo tablets per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC). It is for placebo period only before unblinding.
895878|NCT01103323|E1|Reported Event|Regorafenib (BAY73-4506)+BSC|Participants received Regorafenib 160 mg per oral once daily for 3 weeks on 1 week off of every 4 week cycle plus best supportive care (BSC).
895879|NCT01103284|B3|Baseline|Total|Total of all reporting groups
895880|NCT01103284|B2|Baseline|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895881|NCT01103284|B1|Baseline|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895882|NCT01103284|P2|Participant Flow|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895883|NCT01103284|P1|Participant Flow|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895884|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895885|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895886|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895887|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895888|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895889|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895890|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895891|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895892|NCT01103284|O2|Outcome|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895893|NCT01103284|O1|Outcome|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895894|NCT01103284|E2|Reported Event|Placebo|"Administration of placebo, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~Placebo: 40 mg mannitol in 0.5 mL of solution.~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
895895|NCT01103284|E1|Reported Event|DiaPep277|"Administration of 1 mg DiaPep277®, subcutaneously (s.c.) in the upper arm at 0, 1, 3, 6, 9, 12, 15, 18, 21, and 24 months, for a total of 10 administrations.~DiaPep277: 1.0 mg dose in 0.5 mL of solution"
895896|NCT01103271|B3|Baseline|Total|Total of all reporting groups
895897|NCT01103271|B2|Baseline|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
895898|NCT01103271|B1|Baseline|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
895899|NCT01103271|P2|Participant Flow|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
895900|NCT01103271|P1|Participant Flow|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
895901|NCT01103271|O2|Outcome|Placebo Comparator: Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
895902|NCT01103271|O1|Outcome|Open Label-Placebo: Immediate Treatment|Participants assigned to immediate treatment will begin taking placebo pills for four weeks immediately after enrolling in the study.
895903|NCT01103271|O1|Outcome|Placebo Effect Study|These were all participants who were screened for the study but not yet enrolled.
895904|NCT01103271|E2|Reported Event|Waitlist Treatment|Participants will wait two weeks after enrolling in the study to begin taking placebo pills for four weeks.
895905|NCT01103271|E1|Reported Event|Immediate Treatment|Participants will begin taking placebo pills for four weeks immediately after enrolling in the study.
895906|NCT01103232|B3|Baseline|Total|Total of all reporting groups
895907|NCT01103232|B2|Baseline|Control|Transcutaneous electrical nerve stimulation was applied
895908|NCT01103232|B1|Baseline|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
895909|NCT01103232|P2|Participant Flow|Control|Transcutaneous electrical nerve stimulation was applied
895910|NCT01103232|P1|Participant Flow|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
895911|NCT01103232|O2|Outcome|Control|Transcutaneous electrical nerve stimulation was applied
895912|NCT01103232|O1|Outcome|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
895913|NCT01103232|E2|Reported Event|Control|Transcutaneous electrical nerve stimulation was applied
895914|NCT01103232|E1|Reported Event|Experimental|Electrical muscle stimulation of the right wrist flexor muscles was applied
895915|NCT01103141|B3|Baseline|Total|Total of all reporting groups
895916|NCT01103141|B2|Baseline|Routine Access|Standard gauge-18 large-bore needle
895917|NCT01103141|B1|Baseline|Micropuncture|Gauge-21 Micropuncture® needle
895918|NCT01103141|P2|Participant Flow|Routine Access|Standard gauge-18 large-bore needle
895919|NCT01103141|P1|Participant Flow|Micropuncture|Gauge-21 Micropuncture® needle
895920|NCT01103141|O2|Outcome|Routine Access|Standard gauge-18 large-bore needle
895921|NCT01103141|O1|Outcome|Micropuncture|Gauge-21 Micropuncture® needle
895922|NCT01103141|E2|Reported Event|Routine Access|Standard gauge-18 large-bore needle
895923|NCT01103141|E1|Reported Event|Micropuncture|Gauge-21 Micropuncture® needle
895924|NCT01103063|B3|Baseline|Total|Total of all reporting groups
895925|NCT01103063|B2|Baseline|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895926|NCT01103063|B1|Baseline|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895927|NCT01103063|P2|Participant Flow|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895928|NCT01103063|P1|Participant Flow|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895929|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895930|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895931|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895932|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895933|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895934|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895935|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895936|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895937|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895938|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895939|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895940|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
896326|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
897968|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
895941|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895942|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895943|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895944|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895945|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895946|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895947|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895948|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895949|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895950|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895951|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895952|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895953|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895954|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895955|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895956|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895957|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895958|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895959|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895960|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895961|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
896010|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
895962|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895963|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895964|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895965|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895966|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895967|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895968|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895969|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895970|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895971|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895972|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895973|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895974|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895975|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895976|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895977|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895978|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895979|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895980|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895981|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895982|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
896011|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
895983|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895984|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895985|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895986|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895987|NCT01103063|O2|Outcome|Sulfadoxine + Pyrimethamine|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895988|NCT01103063|O1|Outcome|Azithromycin + Chloroquine|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895989|NCT01103063|E4|Reported Event|Neonate (Sulfadoxine + Pyrimethamine)|Live births of participants who received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895990|NCT01103063|E3|Reported Event|Neonate (Azithromycin + Chloroquine)|Live births of participants who received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895991|NCT01103063|E2|Reported Event|Mother (Sulfadoxine + Pyrimethamine)|The participants received sulfadoxine-pyrimethamine (SP) (Fansidar) treatment course: 1500 mg sulfadoxine and 75 mg pyrimethamine (3 fixed tablets of SP strength at 500 mg/25 mg), single oral dose on Day 0 of each treatment. There were a total of 3 treatments at 4-8 week intervals.
895992|NCT01103063|E1|Reported Event|Mother (Azithromycin + Chloroquine)|The participants received 1000 mg Azithromycin (AZ) and 620 mg of Chloroquine (CQ) base (4 combination tablets of AZCQ with individual strength of 250 mg/155 mg), by mouth once daily for 3 days (Days 0, 1, 2) per treatment. There were a total of 3 treatments at 4-8 week intervals.
895993|NCT01102972|B3|Baseline|Total|Total of all reporting groups
895994|NCT01102972|B2|Baseline|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
895995|NCT01102972|B1|Baseline|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
895996|NCT01102972|P2|Participant Flow|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
895997|NCT01102972|P1|Participant Flow|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
895998|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
895999|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896000|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896001|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896002|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896003|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896004|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896005|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896006|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896007|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896008|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896009|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896012|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896013|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896014|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896015|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896016|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896017|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896018|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896019|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896020|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896021|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896022|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896023|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896024|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896025|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896026|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896027|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896028|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896029|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896030|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896031|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896032|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896033|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896034|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896035|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896036|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896037|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896038|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896039|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896040|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896041|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896140|NCT01102218|P2|Participant Flow|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
899008|NCT01091103|E1|Reported Event|Enzalutamide|
896042|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896043|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896044|NCT01102972|O2|Outcome|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896045|NCT01102972|O1|Outcome|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896046|NCT01102972|E2|Reported Event|TDF/FTC + ATV/RTV|Tenofovir (TDF) 300 mg/Emtricitabine (FTC) 200 mg FDC tablet QD plus Atazanavir (ATV) 300 mg (given as oral capsules)/Ritonavir (RTV) 100 mg (given as oral capsules) QD for 48 weeks
896047|NCT01102972|E1|Reported Event|ABC/3TC + ATV|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 400 mg (given as oral capsules) QD for 48 weeks
896048|NCT01102894|B1|Baseline|Low Fiber and High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time Subjects also consumed low fiber~SmartPill : SmartPill"
896049|NCT01102894|P1|Participant Flow|High Fiber and Low Fiber|"Subjects consume a low and high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896050|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896051|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896052|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896053|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896054|NCT01102894|O2|Outcome|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896055|NCT01102894|O1|Outcome|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896056|NCT01102894|E2|Reported Event|Low Fiber|"Subjects consume a low fiber cereal and swallow the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896057|NCT01102894|E1|Reported Event|High Fiber|"Subjects consume a high fiber cereal along with swallowing the SmartPill device that measures gastrointestinal transit time~SmartPill : SmartPill"
896058|NCT01102491|B3|Baseline|Total|Total of all reporting groups
896059|NCT01102491|B2|Baseline|Control|no antiemetic prophylaxis
896060|NCT01102491|B1|Baseline|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
896061|NCT01102491|P2|Participant Flow|Control|no antiemetic prophylaxis
896062|NCT01102491|P1|Participant Flow|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
896063|NCT01102491|O2|Outcome|Control|no antiemetic prophylaxis
896064|NCT01102491|O1|Outcome|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
896065|NCT01102491|E2|Reported Event|Control|no antiemetic prophylaxis
896066|NCT01102491|E1|Reported Event|Ramosetron Prophylaxis|ramosetron prophylaxis at the end of surgery with starting PCA and 1 day after surgery
896067|NCT01102413|B3|Baseline|Total|Total of all reporting groups
896068|NCT01102413|B2|Baseline|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
896069|NCT01102413|B1|Baseline|Monofer|"Injections or infusions~Monofer: Infusion or injections"
896070|NCT01102413|P2|Participant Flow|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
896071|NCT01102413|P1|Participant Flow|Monofer|"Injections or infusions~Monofer: Infusion or injections"
896072|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
896073|NCT01102413|O1|Outcome|Monofer|"Injections or infusions~Monofer: Infusion or injections"
896074|NCT01102413|O2|Outcome|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
896075|NCT01102413|O1|Outcome|Monofer|"Injections or infusions~Monofer: Infusion or injections"
896076|NCT01102413|E2|Reported Event|Iron Sulphate|"Oral intake~Iron Sulphate: Oral intake"
896077|NCT01102413|E1|Reported Event|Monofer|"Injections or infusions~Monofer: Infusion or injections"
896078|NCT01102374|B3|Baseline|Total|Total of all reporting groups
896079|NCT01102374|B2|Baseline|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896080|NCT01102374|B1|Baseline|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896081|NCT01102374|P2|Participant Flow|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896082|NCT01102374|P1|Participant Flow|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896500|NCT01100502|B1|Baseline|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
896083|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896084|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896085|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896086|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896087|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896088|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896089|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896090|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896091|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896092|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896093|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896094|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896095|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896096|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896097|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896098|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896099|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896100|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896101|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896102|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896141|NCT01102218|P1|Participant Flow|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
896142|NCT01102218|O2|Outcome|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
896103|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896104|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896105|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896106|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896107|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896108|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896109|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896110|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896111|NCT01102374|O2|Outcome|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896112|NCT01102374|O1|Outcome|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896113|NCT01102374|E2|Reported Event|Standard Dose Vitamin D|"12,000 IU Vitamin D3 (cholecalciferol) or placebo monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 400-1,000 IU per day.~Standard Dose Vitamin D: Vitamin D 12,000 IU monthly~Placebo: Placebo monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896114|NCT01102374|E1|Reported Event|High Dose Vitamin D|"100,000 IU Vitamin D3 (cholecalciferol) monthly for 12 months. When added to usual care (0-1000 IU Vitamin D per day), averages 3,300-4,300 IU per day.~High Dose Vitamin D: Vitamin D3 100,000 IU monthly~Usual Care: Usual care of 0-1000 IU vitamin D daily. This is present in both study arms."
896115|NCT01102270|B1|Baseline|All Study Participants|all study participants who received all interventions
896116|NCT01102270|P2|Participant Flow|Sugar Pill First, Then Eszopiclone|Placebo : 1 placebo capsule prior to sleep then 3mg eszopiclone 1 week later
896117|NCT01102270|P1|Participant Flow|Eszopiclone First, Then Sugar Pill|Eszopiclone : 3mg tablet once prior to sleep followed by sugar pill (placebo) 1 week later
896118|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
896119|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
896120|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
896121|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
896122|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
896123|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
896124|NCT01102270|O2|Outcome|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
896125|NCT01102270|O1|Outcome|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
896126|NCT01102270|E2|Reported Event|Sugar Pill|Placebo : 1 placebo capsule prior to sleep
896127|NCT01102270|E1|Reported Event|Eszopiclone|Eszopiclone : 3mg tablet once prior to sleep
896128|NCT01102257|B3|Baseline|Total|Total of all reporting groups
896129|NCT01102257|B2|Baseline|Olive Oil|5 Gel Capsules of olive oil taken orally daily
896130|NCT01102257|B1|Baseline|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
896131|NCT01102257|P2|Participant Flow|Olive Oil|5 Gel Capsules of olive oil to be taken orally daily
896132|NCT01102257|P1|Participant Flow|Omega-3 Supplement|5 Gel Capsules to be taken orally daily to give a total dose of 2000mg EPA and 1000 mg DHA
896133|NCT01102257|O2|Outcome|Olive Oil|5 Gel Capsules of olive oil taken orally daily
896134|NCT01102257|O1|Outcome|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
896135|NCT01102257|E2|Reported Event|Olive Oil|5 Gel Capsules of olive oil taken orally daily
896136|NCT01102257|E1|Reported Event|Omega-3 Supplement|5 Gel Capsules taken orally to achieve a daily dose of 2000mg EPA and 1000mg DHA
896137|NCT01102218|B3|Baseline|Total|Total of all reporting groups
896138|NCT01102218|B2|Baseline|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
896139|NCT01102218|B1|Baseline|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
896172|NCT01101841|B3|Baseline|Total|Total of all reporting groups
896143|NCT01102218|O1|Outcome|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
896144|NCT01102218|E2|Reported Event|Erythropoietin Alone|Standard of care prescribed erythropoietin dose.
896145|NCT01102218|E1|Reported Event|Erythropoietin Plus Pentoxifylline|Standard of care prescribed erythropoietin dose plus 400mg oral pentoxifylline once a day.
896146|NCT01101971|B1|Baseline|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
896147|NCT01101971|P1|Participant Flow|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
896148|NCT01101971|O1|Outcome|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
896149|NCT01101971|E1|Reported Event|First Year Medical Students|Pelvic exam video tutorial: Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
896150|NCT01101958|B3|Baseline|Total|Total of all reporting groups
896151|NCT01101958|B2|Baseline|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896152|NCT01101958|B1|Baseline|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896153|NCT01101958|P2|Participant Flow|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896154|NCT01101958|P1|Participant Flow|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896155|NCT01101958|O2|Outcome|Treatment Arm--CV Positive|This arm was determined to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896156|NCT01101958|O1|Outcome|Treatment Arm--CV Negative|This arm was determined to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896157|NCT01101958|E2|Reported Event|Treatment Arm--CV Positive|This arm had emphysema and was determined during bronchoscopy to have collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896158|NCT01101958|E1|Reported Event|Treatment Arm--CV Negative|This arm had emphysema and was determined during bronchoscopy to have little or no collateral ventilation in the target treatment lobe as measured using the Chartis Pulmonary Assessment System.
896159|NCT01101867|B3|Baseline|Total|Total of all reporting groups
896160|NCT01101867|B2|Baseline|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
896161|NCT01101867|B1|Baseline|Flexible Dose|aspart dose determined based upon carbohydrate intake.
896162|NCT01101867|P2|Participant Flow|Fixed Dose|Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
896163|NCT01101867|P1|Participant Flow|Flexible Dose|Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).
896164|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
896165|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
896166|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
896167|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
896168|NCT01101867|O2|Outcome|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
896169|NCT01101867|O1|Outcome|Flexible Dose|aspart dose determined based upon carbohydrate intake.
896170|NCT01101867|E2|Reported Event|Fixed Dose|fixed meal dose of aspart (based upon weight or total daily insulin dose)
896171|NCT01101867|E1|Reported Event|Flexible Dose|aspart dose determined based upon carbohydrate intake.
896173|NCT01101841|B2|Baseline|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896174|NCT01101841|B1|Baseline|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
896175|NCT01101841|P2|Participant Flow|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896176|NCT01101841|P1|Participant Flow|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
896177|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896178|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896179|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896180|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896181|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896182|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896183|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896184|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896185|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896186|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896187|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896188|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896189|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896190|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896191|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896192|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896193|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896194|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896195|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896196|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896197|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896198|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896199|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896200|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896201|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896202|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either MesaBrisdelle (paroxetine mesylate) Capsules fem or placebo capsules in a 1:1 ratio.
896203|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896204|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896205|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896206|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896207|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896208|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896209|NCT01101841|O2|Outcome|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
904937|NCT01075685|O2|Outcome|Minimum Information|
896210|NCT01101841|O1|Outcome|Brisdelle (Paroxetine Mesylate) Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896211|NCT01101841|E2|Reported Event|Placebo Capsules|Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio.
896212|NCT01101841|E1|Reported Event|Brisdelle (Paroxetine Mesylate) Capsules|"Experimental~Eligible subjects were randomized to receive either Brisdelle (paroxetine mesylate) Capsules or placebo capsules in a 1:1 ratio."
896213|NCT01101542|B1|Baseline|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
896214|NCT01101542|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
896215|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896216|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896217|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896218|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896219|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896220|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896221|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896222|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896223|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896224|NCT01101542|O1|Outcome|Cervarix Group|Subjects received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule is necessary, the second dose can be administered between 1 month and 2.5 months after the first dose.
896225|NCT01101542|E4|Reported Event|Cervarix Year 6 Group|Subjects enrolled for surveillance Year 6, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
896226|NCT01101542|E3|Reported Event|Cervarix Year 5 Group|Subjects enrolled for surveillance Year 5, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
896227|NCT01101542|E2|Reported Event|Cervarix Year 4 Group|Subjects enrolled for surveillance Year 4, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
896259|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896501|NCT01100502|P2|Participant Flow|Placebo|placebo every 3 weeks by IV infusion
896228|NCT01101542|E1|Reported Event|Cervarix Year 3 Group|Subjects enrolled for surveillance Year 3, who received 3 doses of the Cervarix vaccine. The vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0,1, 6 month vaccination schedule. According to the prescribing information, if flexibility in the vaccination schedule was necessary, the second dose could be administered between 1 month and 2.5 months after the first dose.
896229|NCT01101477|B4|Baseline|Total|Total of all reporting groups
896230|NCT01101477|B3|Baseline|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896231|NCT01101477|B2|Baseline|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896232|NCT01101477|B1|Baseline|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896233|NCT01101477|P3|Participant Flow|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896234|NCT01101477|P2|Participant Flow|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896235|NCT01101477|P1|Participant Flow|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896236|NCT01101477|O3|Outcome|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896237|NCT01101477|O2|Outcome|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896238|NCT01101477|O1|Outcome|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896239|NCT01101477|E3|Reported Event|Titration by Cet 0.1μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896240|NCT01101477|E2|Reported Event|Titration by Cet 0.2μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896241|NCT01101477|E1|Reported Event|Titration by Target Effect Site Concentration (Cet) 0.5μg/ml|The investigator will titrate the Cet to keep stable vital signs and sedative level during the flexible bronchoscopy. The criteria for titration is descried in the intervention.
896242|NCT01101464|B3|Baseline|Total|Total of all reporting groups
896243|NCT01101464|B2|Baseline|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days
896244|NCT01101464|B1|Baseline|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
896245|NCT01101464|P2|Participant Flow|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
896246|NCT01101464|P1|Participant Flow|Asenapine, (3) 5mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days.
896247|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant).
896248|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant).
896249|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
896250|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
896251|NCT01101464|O2|Outcome|Asenapine 1x15mg|One 15 mg sublingual tablet given twice daily for 2 or 1.5 days (depending on sequence of participant)
896252|NCT01101464|O1|Outcome|Asenapine 3x5mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 or 1.5 days (depending on sequence of participant)
896253|NCT01101464|E2|Reported Event|Asenapine, (1) 15 mg Then (3) 5 mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
896254|NCT01101464|E1|Reported Event|Asenapine, (3) 5 mg Then (1) 15 mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
896255|NCT01101321|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896256|NCT01101321|P2|Participant Flow|Reformulated OXY (Wilson) (Reference) First|Reformulated OXY 80-mg tablet (Wilson) (Reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Wilson) (Reference) in period 1 and Reformulated OXY (Totowa) (Test) in period 2.
896257|NCT01101321|P1|Participant Flow|Reformulated OXY (Totowa) (Test) First|Reformulated OXY 80-mg tablet (Totowa)(Test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Totowa) (Test) in period 1 and Reformulated OXY (Wilson) (Reference) in period 2.
896258|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
904938|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
896260|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896261|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896262|NCT01101321|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896263|NCT01101321|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896264|NCT01101321|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 80-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896265|NCT01101321|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896266|NCT01101308|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896267|NCT01101308|P2|Participant Flow|Reformulated OXY 10 mg (Wilson) (Reference) First|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Wilson) (Reference) in period 1 and reformulated OXY (Totowa) (Test) in period 2.
896268|NCT01101308|P1|Participant Flow|Reformulated OXY 10 mg (Totowa) (Test) First|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received reformulated OXY (Totowa) (Test) in period 1 and reformulated OXY (Wilson) (Reference)in period 2.
896269|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896270|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896271|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896272|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896273|NCT01101308|O2|Outcome|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896274|NCT01101308|O1|Outcome|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896275|NCT01101308|E3|Reported Event|Prerandomization|
896276|NCT01101308|E2|Reported Event|Reformulated OXY (Wilson) (Reference)|Reformulated OXY 10-mg tablet Wilson, NC (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896277|NCT01101308|E1|Reported Event|Reformulated OXY (Totowa) (Test)|Reformulated OXY 10-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896278|NCT01101191|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896279|NCT01101191|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896280|NCT01101191|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896281|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896282|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896283|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896284|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896285|NCT01101191|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896286|NCT01101191|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896287|NCT01101191|E3|Reported Event|Prerandomization|
896288|NCT01101191|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896289|NCT01101191|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896290|NCT01101178|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896324|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896325|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896291|NCT01101178|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
896292|NCT01101178|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
896293|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
896294|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896295|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
896296|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896297|NCT01101178|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (oxycodone [OXY]) 80-mg tablet (reference) fed, dose administered in a 2-period, 2-sequence, single-dose, 2-way crossover fashion.
896298|NCT01101178|O1|Outcome|Reformulated Oxycodone (OXY) (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896299|NCT01101178|E3|Reported Event|Screening|
896300|NCT01101178|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 80-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896301|NCT01101178|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 80-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896302|NCT01101165|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896303|NCT01101165|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin(OXY)(Reference)in period 1 and Reformulated OXY (Test) in period 2.
896304|NCT01101165|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
896305|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896306|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896307|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896308|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896309|NCT01101165|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896310|NCT01101165|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896311|NCT01101165|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896312|NCT01101165|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fasted, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896313|NCT01101022|B3|Baseline|Total|Total of all reporting groups
896314|NCT01101022|B2|Baseline|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896315|NCT01101022|B1|Baseline|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896316|NCT01101022|P2|Participant Flow|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896317|NCT01101022|P1|Participant Flow|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896318|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896319|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896320|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896321|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896322|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896323|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896327|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896328|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896329|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896330|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896331|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896332|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896333|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896334|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896335|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896336|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896337|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896338|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896339|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896340|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896341|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896342|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896343|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896344|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896345|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896346|NCT01101022|O2|Outcome|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896347|NCT01101022|O1|Outcome|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896348|NCT01101022|E2|Reported Event|Placebo|Dosed orally once a day at approximately 7:00 AM for 10 weeks.
896349|NCT01101022|E1|Reported Event|SPD489|Dosed orally once a day at approximately 7:00 AM at either 30, 50 or 70 mg for 10 weeks (a 4-week dose optimization period followed by a 6-week dose maintenance period at an optimal dose).
896350|NCT01100944|B1|Baseline|All Participants|All participants who had at least one dose of Belinostat.
896351|NCT01100944|P3|Participant Flow|Belinostat and Chemotherapy at the Maximum Tolerated Dose(MTD)|Patients were treated with belinostat, doxorubicin, cisplatin and cyclophosphamide at the maximum tolerated dose derived from the phase I dose level.
896352|NCT01100944|P2|Participant Flow|Belinostat 500mg/m(2) and Chemotherapy|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896353|NCT01100944|P1|Participant Flow|Belinostat 250mg/m(2) and Chemotherapy|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896354|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896410|NCT01100853|B1|Baseline|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896411|NCT01100853|P2|Participant Flow|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896502|NCT01100502|P1|Participant Flow|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
896355|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896356|NCT01100944|O1|Outcome|All Participants|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896357|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896358|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896359|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896360|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896361|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896362|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896363|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896364|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896365|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896366|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896367|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896368|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896369|NCT01100944|O2|Outcome|Phase 1 Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896370|NCT01100944|O1|Outcome|Phase 1 Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896371|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896372|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896373|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896412|NCT01100853|P1|Participant Flow|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896503|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
896374|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.~PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896375|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896376|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896377|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896378|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896379|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896380|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) or 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896381|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896413|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896504|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
896382|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896383|NCT01100944|O1|Outcome|Thymic Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896384|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat.~PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896385|NCT01100944|O2|Outcome|Thymoma Participants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896386|NCT01100944|O1|Outcome|Thymic Particpants|"PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896387|NCT01100944|O3|Outcome|All Participants|All participants who had at least one dose of belinostat.
896388|NCT01100944|O2|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896389|NCT01100944|O1|Outcome|Phase I Dose Level 1 + Phase 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD) and was utilized in the expansion phase (phase 2)."
896390|NCT01100944|O1|Outcome|All Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896414|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896415|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896391|NCT01100944|O3|Outcome|Thymic and Thymoma Participants|"All participants who had at least one dose of belinostat. PXD101 (Belinostat) will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2, 3, cisplatin will be infused over 1 hr on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.~The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas."
896392|NCT01100944|O2|Outcome|Thymoma Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
896393|NCT01100944|O1|Outcome|Thymic Participants|The thymic tumors are rare tumors that arise from the thymus and are histologically composed of epithelial cells which are the putative source of malignancy, B and T lymphocytes, interdigitating reticulum cells, macrophages, and myeloid cells. The most common tumors of the thymus are thymomas (well-differentiated neoplasms), atypical thymomas (moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
896394|NCT01100944|O1|Outcome|Phase I Dose Level 2|"Patients received 500mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896395|NCT01100944|O1|Outcome|Phase I Dose Level 1 & Phase I Dose Level 2|"Patients received 250mg/m(2) of belinostat via four consecutive 12 hour continuous intravenous infusion (CIVI) for 48 hours starting on day 1. At dose levels 1 and 2, patients received the same doses of doxorubicin (25mg/m(2) on days 2 and 3, intravenous push over 3-5 minutes), cisplatin (50 mg/m(2) over 60 minutes intravenous on day 2 after doxorubicin), and cyclophosphamide (500mg/m(2) over 60 minutes intravenous on day 3 after doxorubicin). Combination of chemotherapy and belinostat was repeated every 21 days for a total of 6 cycles unless there was evidence of disease progression or intolerance of the study treatment.~A conventional 3 + 3 dose escalation design was used to determine maximum tolerated dose (MTD)."
896396|NCT01100944|E1|Reported Event|All Participants|All participants who had at least one dose of belinostat.
896397|NCT01100931|B3|Baseline|Total|Total of all reporting groups
896398|NCT01100931|B2|Baseline|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
896399|NCT01100931|B1|Baseline|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
896400|NCT01100931|P2|Participant Flow|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
896401|NCT01100931|P1|Participant Flow|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
896402|NCT01100931|O2|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
896403|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
896404|NCT01100931|O1|Outcome|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
896405|NCT01100931|O1|Outcome|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
896406|NCT01100931|E2|Reported Event|Phase II|Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days.
896407|NCT01100931|E1|Reported Event|Phase I|Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
896408|NCT01100853|B3|Baseline|Total|Total of all reporting groups
896409|NCT01100853|B2|Baseline|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896498|NCT01100502|B3|Baseline|Total|Total of all reporting groups
896416|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896417|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896418|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896419|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896420|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896421|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896422|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896423|NCT01100853|O2|Outcome|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896424|NCT01100853|O1|Outcome|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896425|NCT01100853|E2|Reported Event|VIVITROL Placebo Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896426|NCT01100853|E1|Reported Event|VIVITROL Injection, 24 Weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
896427|NCT01100762|B1|Baseline|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
896428|NCT01100762|P1|Participant Flow|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
896429|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
896430|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
896431|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
896432|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
896433|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
896434|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
896435|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
896436|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
896437|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
896438|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
896439|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
896440|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
896441|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
896505|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
896442|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
896443|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
896444|NCT01100762|O3|Outcome|CES and Treadmill|In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions.
896445|NCT01100762|O2|Outcome|Treadmill|In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject's preferred speed on the treadmill for 20 minutes.
896446|NCT01100762|O1|Outcome|Cranial Electric Stimulation (CES)|In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.
896447|NCT01100762|E1|Reported Event|Single Group|"In week one, the intervention consisted of a 20 minute session of Cranial Electric Stimulation (CES). The CES dosage: the CES delivered 0.965 mA at a frequency of 5,625 pulses per second given for 20 minutes.~In week two, the intervention was a 20 minute session walking on a treadmill. The treadmill dosage: walking at the individual subject’s preferred speed on the treadmill for 20 minutes.~In week three, the intervention was the application of CES while walking on the treadmill for 20 minutes. The CES and treadmill dosage: subjects used a combination of CES and treadmill using the same dosage of the previous two intervention sessions."
896448|NCT01100723|B1|Baseline|Post Treatment|Results analyzed at study evaluation time points.
896449|NCT01100723|P1|Participant Flow|Post Treatment|Patients had their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet dose was increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
896450|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
896451|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
896452|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
896453|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
896454|NCT01100723|O1|Outcome|Results Analyzed at Study Evaluation Time Points.|Results analyzed at study evaluation time points of 1 year and 6 months.
896455|NCT01100723|O1|Outcome|Post Treatment|Results analyzed at study evaluation time points.
896456|NCT01100723|E1|Reported Event|Post Treatment|Results analyzed at study evaluation time points.
896457|NCT01100658|B1|Baseline|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
896458|NCT01100658|P1|Participant Flow|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
896459|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
896460|NCT01100658|O1|Outcome|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
896461|NCT01100658|E1|Reported Event|Participant With Attention Deficit|Participant previously had acute lymphoblastic leukemia or brain tumor to be treated with Methylphenidate or Placebo - Administered 1 capsule each day for 1 week, .3 mg/kg dose.
896462|NCT01100606|B1|Baseline|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
896463|NCT01100606|P2|Participant Flow|EUR-1008 (APT-1008) in Apple Sauce First, Then in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kg/day.
896464|NCT01100606|P1|Participant Flow|EUR-1008 (APT-1008) in Apple Juice First, Then in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in first treatment period followed by EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in second treatment period. Total dose was not to exceed 10,000 lipase units/kilogram body weight/day (lipase units/kg/day).
896465|NCT01100606|O1|Outcome|Entire Study Population|Includes all enrolled participants who received EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple juice using a syringe nurser first and EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) mixed with a small amount of apple sauce using a spoon first.
896466|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896467|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsules) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily with dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896499|NCT01100502|B2|Baseline|Placebo|placebo every 3 weeks by IV infusion
896468|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896469|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896470|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896471|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896472|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896473|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896474|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896475|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896476|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896477|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896478|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896479|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896480|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896481|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896482|NCT01100606|O2|Outcome|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896483|NCT01100606|O1|Outcome|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896484|NCT01100606|E3|Reported Event|EUR-1008 (APT-1008) in Apple Sauce|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce using a spoon, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896485|NCT01100606|E2|Reported Event|EUR-1008 (APT-1008) in Apple Juice|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice using a syringe nurser, orally daily at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period.
896486|NCT01100606|E1|Reported Event|Zenpep®|Zenpep® 5,000 from open capsule, mixed with a small amount of apple sauce, orally daily in the screening period for 10 days.
896487|NCT01100567|B3|Baseline|Total|Total of all reporting groups
896488|NCT01100567|B2|Baseline|Placebo|Randomized to sham platform 10 min daily
896489|NCT01100567|B1|Baseline|LMMS|Randomized to 10 min LMMS daily
896490|NCT01100567|P2|Participant Flow|Placebo|Randomized to sham platform 10 min daily
896491|NCT01100567|P1|Participant Flow|LMMS|Randomized to 10 min LMMS daily
896492|NCT01100567|O2|Outcome|Placebo|Randomized to sham platform 10 min daily
896493|NCT01100567|O1|Outcome|LMMS|Randomized to 10 min LMMS daily
896494|NCT01100567|O2|Outcome|Placebo|Randomized to sham platform 10 min daily
896495|NCT01100567|O1|Outcome|LMMS|Randomized to 10 min LMMS daily
896496|NCT01100567|E2|Reported Event|Placebo|Randomized to sham platform 10 min daily
896497|NCT01100567|E1|Reported Event|LMMS|Randomized to 10 min LMMS daily
896506|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
896507|NCT01100502|O2|Outcome|Placebo|placebo every 3 weeks by IV infusion
896508|NCT01100502|O1|Outcome|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
896509|NCT01100502|E2|Reported Event|Brentuximab Vedotin|brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
896510|NCT01100502|E1|Reported Event|Placebo|placebo every 3 weeks by IV infusion
896511|NCT01100437|B1|Baseline|Entire Study Population|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participant’s pain up to 35 days. The participants then started the Maintenance Phase and were administered the established stable dose of EMBEDA for a minimum of 7 days up to 28 days. Eligible participants were randomized into the 2 treatment groups.
896512|NCT01100437|P3|Participant Flow|EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the titration and stabilization phase EMBEDA was administrated and titrated to a dose that adequately managed the participants pain for up to 35 days. In the Maintenance Phase the participant’s were administered the established stable dose for a minimum of 7 days up to 28 days. Participants were not randomized to treatment phase.
896513|NCT01100437|P2|Participant Flow|EMBEDA Solution Then EMBEDA Capsule|EMBEDA (morphine sulfate plus naltrexone hydrochloride) ER capsule(s) were administered orally once or twice a day (20 mg to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participants were administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered crushed EMBEDA capsules orally at participants stable dose mixed in solution along with matched placebo capsules in the first intervention period. In the second intervention period the participant received whole EMBEDA capsules administered orally at participant’s stable dose along with matched placebo solution.
896514|NCT01100437|P1|Participant Flow|EMBEDA Capsule Then EMBEDA Solution|EMBEDA (morphine sulfate plus naltrexone hydrochloride) Extended Release (ER) capsule(s) were administered orally once or twice a day (20 milligrams [mg] to 120 mg). During the open label titration and stabilization phase EMBEDA was administered and titrated to a dose that adequately managed the participants pain up to 35 days. In the open label Maintenance Phase the participant was administered the established stable dose for a minimum of 7 days up to 28 days. The participant was then randomized to one of two double-blind treatment sequences for the Treatment Phase. During the Treatment Phase the participant was administered whole EMBEDA capsules orally at participant’s stable dose along with a matched placebo solution in the first intervention period. In the second intervention period the participant received crushed EMBEDA capsules that were mixed in solution and administered orally at participant's stable dose along with matched placebo capsules.
896515|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896516|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896517|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896518|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896519|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896520|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896521|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896522|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896523|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896524|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896525|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896526|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896527|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896528|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896529|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896530|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896531|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896532|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896533|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896534|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896535|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896536|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896537|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896538|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896539|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896540|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896541|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896542|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896543|NCT01100437|O1|Outcome|EMBEDA Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896544|NCT01100437|O2|Outcome|EMBEDA Crushed in Solution|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily with matched placebo whole capsules in any treatment period.
896545|NCT01100437|O1|Outcome|EMBEDA Whole Capsules|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896546|NCT01100437|E4|Reported Event|EMBEDA Capsules Maintenance Period|EMBEDA capsule(s) administered orally once or twice a day dose (20 mg go 120 mg) at the participants stable dose for 7 days minimum.
896547|NCT01100437|E3|Reported Event|EMBEDA Capsule Titration/Stabilization Period|EMBEDA capsule(s) administered orally once or twice a day (20 mg go 120 mg) to adequately manage the participants pain.
896548|NCT01100437|E2|Reported Event|EMBEDA Crushed in Solution Treatment Period|EMBEDA capsules crushed mixed in solution and administered orally at participant's stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo whole capsules in any treatment period .
896549|NCT01100437|E1|Reported Event|EMBEDA Whole Capsule Treatment Period|EMBEDA whole capsules, administered orally at participant’s stable dose (20 mg to 120 mg), given once or twice daily along with matched placebo solution in any treatment period.
896550|NCT01100320|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896551|NCT01100320|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
896552|NCT01100320|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
896553|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896554|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896555|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896556|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896557|NCT01100320|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896558|NCT01100320|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896884|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896559|NCT01100320|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 40-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896560|NCT01100320|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 40-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896561|NCT01100307|B3|Baseline|Total|Total of all reporting groups
896562|NCT01100307|B2|Baseline|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896563|NCT01100307|B1|Baseline|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896564|NCT01100307|P2|Participant Flow|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896565|NCT01100307|P1|Participant Flow|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896566|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896567|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896568|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896569|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896570|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896571|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896572|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896573|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896574|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896575|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896576|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896577|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896628|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
896885|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896578|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896579|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896580|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896581|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896582|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896583|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896584|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896585|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896586|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896587|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896588|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896589|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896590|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896591|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896592|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896593|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896594|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896595|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896596|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896597|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896598|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896599|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896600|NCT01100307|O2|Outcome|Sham in Double Masked, Then Pegaptanib Sodium in Open Phase|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication. Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896601|NCT01100307|O1|Outcome|Pegaptanib Sodium|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896602|NCT01100307|E4|Reported Event|Sham Conversion (Week 24 to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks in participants who were originally randomized to Sham and entered in the open phase (Week 24 to Week 54). Total number of injection was 5 times in the open phase.
896603|NCT01100307|E3|Reported Event|Pegaptanib Sodium (Baseline to Week 54)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24) and 5 times in the open phase (from Week 24 to Week 54).
896604|NCT01100307|E2|Reported Event|Sham (Baseline to Week 24)|Sham injection was conducted during the double masked phase (up to Week 24) according to the identical procedure of pegaptanib sodium administration, with exceptions of no needle used and no medication.
896605|NCT01100307|E1|Reported Event|Pegaptanib Sodium (Baseline to Week 24)|Pegaptanib sodium 0.3 milligrams were administered as an intravitreous injection every 6 weeks. Total number of injections were 4 times in the double masked phase (up to Week 24).
896606|NCT01100268|B1|Baseline|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
896607|NCT01100268|P1|Participant Flow|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
896608|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
896609|NCT01100268|O1|Outcome|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
896610|NCT01100268|E1|Reported Event|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
896611|NCT01100255|B3|Baseline|Total|Total of all reporting groups
896612|NCT01100255|B2|Baseline|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
896613|NCT01100255|B1|Baseline|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
896614|NCT01100255|P2|Participant Flow|Group B|IV saline infusion over 40 minutes then 0.5mg/kg IV ketamine infusion over 40 minutes
896615|NCT01100255|P1|Participant Flow|Group A|0.5mg/kg IV ketamine infusion over 40 minutes then IV saline infusion over 40 minutes
896616|NCT01100255|O2|Outcome|Ketamine Infusion|"0.5mg/kg IV infusion over 40 minutes~Ketamine infusion: 0.5mg/kg IV over 40 minutes"
896617|NCT01100255|O1|Outcome|Saline Infusion|"IV saline infusion over 40 minutes~Saline: saline infusion"
896618|NCT01100255|E2|Reported Event|Ketamine Infusion|0.5mg/kg IV ketamine infusion over 40 minutes
896619|NCT01100255|E1|Reported Event|Saline Infusion|IV saline infusion over 40 minutes
896620|NCT01100242|B1|Baseline|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
896621|NCT01100242|P1|Participant Flow|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
896622|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
896623|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
896624|NCT01100242|O1|Outcome|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
896625|NCT01100242|E1|Reported Event|VELCADE and Sorafenib|VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
896626|NCT01100112|B1|Baseline|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
896627|NCT01100112|P1|Participant Flow|Budesonide|"Budesonide-multi-matrix system (MMX) 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
896629|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
896630|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
896631|NCT01100112|O1|Outcome|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
896632|NCT01100112|E1|Reported Event|Budesonide|"Budesonide-MMX 9 mg tablet~Budesonide : One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks."
896633|NCT01100086|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896634|NCT01100086|P2|Participant Flow|Original OxyContin® (OXY) (Reference) First|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Original OxyContin® (OXY) (Reference)in period 1 and Reformulated OXY (Test) in period 2.
896635|NCT01100086|P1|Participant Flow|Reformulated OXY (Test) First|Reformulated OXY 10-mg tablet (test) dosed fasted was administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations. Subjects in this sequence received Reformulated OXY (Test) in period 1 and Original OxyContin(OXY)(Reference) in period 2.
896636|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896637|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896638|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896639|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896640|NCT01100086|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896641|NCT01100086|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896642|NCT01100086|E2|Reported Event|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896643|NCT01100086|E1|Reported Event|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) dosed fasted administered in a two-period, two-sequence, single-dose, two-way crossover fashion
896644|NCT01100073|B1|Baseline|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896645|NCT01100073|P1|Participant Flow|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use. The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896646|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896647|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896648|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896649|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896650|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896651|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896652|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896653|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896654|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896655|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896656|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896657|NCT01100073|O1|Outcome|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896658|NCT01100073|E1|Reported Event|Mirapexin® (Pramipexole)|Mirapexin® (Pramipexole) - tablets for oral use The dose of Mirapexin® was selected by the treating physician upon his/her clinical judgement and on individual patient need, according to recommendations given in the Mirapexin® Summary of Product Characteristics.
896659|NCT01099917|B1|Baseline|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
896660|NCT01099917|P1|Participant Flow|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
896661|NCT01099917|O1|Outcome|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
896662|NCT01099917|E1|Reported Event|Maitake|This is a phase II trial examining hematopoietic response in Myelodisplastic Patients.
896663|NCT01099774|B3|Baseline|Total|Total of all reporting groups
896664|NCT01099774|B2|Baseline|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
896665|NCT01099774|B1|Baseline|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
896666|NCT01099774|P2|Participant Flow|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
896667|NCT01099774|P1|Participant Flow|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
896668|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
896669|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
896670|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
896671|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
896672|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
896673|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
896674|NCT01099774|O2|Outcome|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
896675|NCT01099774|O1|Outcome|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
896676|NCT01099774|E2|Reported Event|Bimatoprost 0.03% Ophthalmic Solution|Bimatoprost 0.03% Ophthalmic Solution
896677|NCT01099774|E1|Reported Event|Bimatoprost 0.03% Formulation B Ophthalmic Solution|Bimatoprost 0.03% Formulation B Ophthalmic Solution
896678|NCT01099761|B5|Baseline|Total|Total of all reporting groups
896679|NCT01099761|B4|Baseline|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896680|NCT01099761|B3|Baseline|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896681|NCT01099761|B2|Baseline|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896682|NCT01099761|B1|Baseline|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896683|NCT01099761|P4|Participant Flow|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896684|NCT01099761|P3|Participant Flow|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896685|NCT01099761|P2|Participant Flow|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896686|NCT01099761|P1|Participant Flow|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896687|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896688|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896689|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896690|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896691|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896692|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896693|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896694|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896695|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896696|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896697|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896698|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896699|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896700|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896701|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896702|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896703|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896704|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896705|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896706|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896707|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896708|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896709|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896710|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896711|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896712|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896713|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896714|NCT01099761|O3|Outcome|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896715|NCT01099761|O2|Outcome|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896716|NCT01099761|O1|Outcome|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896717|NCT01099761|E4|Reported Event|Placebo|Placebo: Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
896718|NCT01099761|E3|Reported Event|ACE-031 ACE-03 2.5 mg/kg q4wk|ACE-031 2.5 mg/kg q4wk: ACE-031 2.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896719|NCT01099761|E2|Reported Event|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg q2wk: ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
896720|NCT01099761|E1|Reported Event|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg q4wk: ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
896721|NCT01099709|B1|Baseline|Randomized Safety Population|Subjects who were randomized, received study drug, and had at least 1 postdose safety assessment.
896722|NCT01099709|P2|Participant Flow|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896723|NCT01099709|P1|Participant Flow|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion. A minimum washout period of at least 6 days separated dose administrations.
896724|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896725|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dosed administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896726|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896727|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896728|NCT01099709|O2|Outcome|Original OxyContin® (OXY) (Reference)|Original OxyContin® (OXY) 10-mg tablet (reference) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896729|NCT01099709|O1|Outcome|Reformulated OXY (Test)|Reformulated OXY 10-mg tablet (test) fed, dose administered in a two-period, two-sequence, single-dose, two-way crossover fashion.
896730|NCT01099709|E2|Reported Event|Original OxyContin® (OXY) 10-mg Tablet (Fed)|Original OxyContin® (OXY) 10-mg tablet (fed) x 1 dose
896731|NCT01099709|E1|Reported Event|Reformulated OXY 10-mg Tablet (Fed)|Reformulated OXY 10-mg tablet (fed) x 1 dose
896732|NCT01099618|B4|Baseline|Total|Total of all reporting groups
896733|NCT01099618|B3|Baseline|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896734|NCT01099618|B2|Baseline|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896735|NCT01099618|B1|Baseline|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896886|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896736|NCT01099618|P3|Participant Flow|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896737|NCT01099618|P2|Participant Flow|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896738|NCT01099618|P1|Participant Flow|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896739|NCT01099618|O3|Outcome|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896740|NCT01099618|O2|Outcome|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896741|NCT01099618|O1|Outcome|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA (N=24) and obese subjects with hyperglycemia without ketoacidosis (n=24) will be equally randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896742|NCT01099618|E3|Reported Event|Placebo|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg(n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~placebo: The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896743|NCT01099618|E2|Reported Event|Sitagliptin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000 mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~Sitagliptin: The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896744|NCT01099618|E1|Reported Event|Metformin|"All newly diagnosed subjects with KPDM that are able to discontinue insulin after 12 weeks or less will be randomized in double-blind fashion to receive either metformin 1000mg, sitagliptin 100mg or placebo once daily. Subjects that do not achieve remission will continue to receive insulin therapy and will discontinue the protocol. A total of 48 obese subjects with DKA and without ketoacidosis will be randomized to receive metformin (MET) 1000 mg (n=16), sitagliptin (SIT) 100mg (n=16) or placebo (n=16).~metformin: The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period."
896745|NCT01099579|B4|Baseline|Total|Total of all reporting groups
896816|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
896887|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896746|NCT01099579|B3|Baseline|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
896747|NCT01099579|B2|Baseline|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
896748|NCT01099579|B1|Baseline|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
896749|NCT01099579|P3|Participant Flow|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
896750|NCT01099579|P2|Participant Flow|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
896751|NCT01099579|P1|Participant Flow|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to <20 kg received ATV, 150 mg, with RTV, 100 mg; those who weighed 20 to <40 mg received ATV, 200, with RTV, 100 mg; and those who weighed at least 40 mg received ATV, 300 mg, with RTV, 100 mg.
896752|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896753|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896888|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896889|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896754|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896755|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896756|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896757|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896758|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896759|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896760|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896761|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896762|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896763|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896764|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896765|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896766|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896767|NCT01099579|O2|Outcome|ARV-naive|ARV treatment-naive participants were those with no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
896768|NCT01099579|O1|Outcome|ARV-experienced|Antiretroviral (ARV) treatment-experienced participants were those with previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
896769|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
896770|NCT01099579|O1|Outcome|ARV- Experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
896771|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896772|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896773|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896774|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
896775|NCT01099579|O1|Outcome|ARV- Experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
896776|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896777|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896778|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896817|NCT01099475|E2|Reported Event|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
896779|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896780|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896781|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896782|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896783|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896784|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896785|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896786|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896787|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896788|NCT01099579|O2|Outcome|ARV-naive|ARV-naive participants had no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
896789|NCT01099579|O1|Outcome|ARV-experienced|ARV-experienced participants had previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
896790|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896890|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896891|NCT01099215|E2|Reported Event|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896791|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896792|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896793|NCT01099579|O2|Outcome|ARV-naive|ARV treatment-naive participants were those with no prior exposure to ARV treatment. Patients exposed to ARVs in utero or intrapartum were also considered treatment naive.
896794|NCT01099579|O1|Outcome|ARV-experienced|Antiretroviral (ARV) treatment-experienced participants were those with previous exposure to ARV drugs through prior treatment for HIV infection or through postnatal treatment with ≥1 ARVs for the prevention of mother-to-child-transmission in accordance with multiple international guidelines.
896795|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896796|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896797|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896798|NCT01099579|O3|Outcome|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896799|NCT01099579|O2|Outcome|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation.
896800|NCT01099579|O1|Outcome|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation.
896801|NCT01099579|E3|Reported Event|Atazanavir Powder, 150 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 5 to <10 kg received atazanavir (ATV), 150-mg powder dosed in 50-mg sachet packets, and ritonavir (RTV) oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
896818|NCT01099475|E1|Reported Event|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
896892|NCT01099215|E1|Reported Event|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896802|NCT01099579|E2|Reported Event|Atazanavir Powder, 250 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 15 to <25 kg received 250 mg of ATV powder dosed in 50-mg sachet packets, with 80 mg of RTV solution. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. The entire contents of the mixture must have been consumed to obtain the full dose. The ritonavir oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight of 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 20 to 40 mg received ATV, 200 mg, with RTV, 100 mg, and those who weighed at least 40 kg received ATV, 300 mg, with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
896803|NCT01099579|E1|Reported Event|Atazanavir Powder, 200 mg/Ritonavir Oral Solution, 80 mg|Patients weighing 10 to <15 kg received ATV powder, 200 mg, dosed in 50-mg sachet packets and RTV oral solution, 80 mg. Stage 1: Initial dose was determined by the patient's weight on the day of the first on-treatment study visit (Day 1). ATV dispersible powder was mixed with a small amount of food or beverage (water, milk, chocolate milk, liquid infant formula, applesauce, or yogurt). If water was used, mixture must have been taken with food. All of the mixture must have been consumed to obtain the full dose. The RTV oral solution was taken immediately before or after the ATV powder preparation. Stage 2: Patients who reached the age of 6 years or a weight 25 kg were transitioned to the capsule formulation of ATV. Those who weighed 15 to 20 kg received ATV, 150 mg, with RTV, 100 mg, and those who weighed 20 to 40 mg received ATV, 200 mg with RTV,100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
896804|NCT01099475|B3|Baseline|Total|Total of all reporting groups
896805|NCT01099475|B2|Baseline|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
896806|NCT01099475|B1|Baseline|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
896807|NCT01099475|P2|Participant Flow|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
896808|NCT01099475|P1|Participant Flow|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
896809|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
896810|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
896811|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
896812|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
896813|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
896814|NCT01099475|O1|Outcome|Pringle Manoeuvre Using 15 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 2 cycles of 15 minutes of hepatic inflow occlusion will be applied each followed by 5 minutes of reperfusion.~Pringle manoeuvre using 15 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion"
896815|NCT01099475|O2|Outcome|Pringle Manoeuvre Using 30 Minutes Inflow Occlusion|"When intermittent pedicle occlusion during parenchymal transection is necessary, 1 cycle of 30 minutes of hepatic inflow occlusion will be applied followed by 5 minutes of reperfusion~Pringle Manoeuvre using 30 minutes ischemic interval: During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion"
896819|NCT01099397|B1|Baseline|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study
896893|NCT01099202|B3|Baseline|Total|Total of all reporting groups
896894|NCT01099202|B2|Baseline|No Procrit|No intervention.
896820|NCT01099397|P1|Participant Flow|PEAR Sub-study Participants|All participants eligible for the PEAR study in Gainesville, FL, starting May 2009, were allowed to participate in the PEAR sub-study; participants enrolled were evaluated at three time points as part of the PEAR protocol, at baseline, 9 weeks and 18 weeks; for each participant at each time point, a fasting glucose value and 2-hour oral glucose tolerance test value was collected and compared
896821|NCT01099397|O2|Outcome|Fasting Glucose|Fasting glucose collected
896822|NCT01099397|O1|Outcome|2-hour Glucose|Glucose collected after a 2 hour oral glucose tolerance test
896823|NCT01099397|E1|Reported Event|PEAR Sub-study Participants|All participants in the PEAR sub-study were evaluated by two methods at 3 time-points in the PEAR parent study
896824|NCT01099358|B1|Baseline|All Participants (All Participants (Group A, B, C and D)|"A:Cycle1:100mg/m² cisplatin(cs) I.V on week(w)1,day(d)1. 5-FU as a 96-hour(h) C.I. of 1000 mg/m²/d starting (st) on w 1,d 1-4.~400mg/m² cetuximab(ct) I.V on w 2,d 1.250mg/m² ct I.V on w 3,d 1.Cycle 2+100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.250mg/m² ct I.V on w 1-3,d 1.~B:Cycle1:400mg/m² ct I.V on w 1,d 1.250mg/m² ct I.V on w 2&3,d 1.Cycle 2:100mg/m² cs I.V on w 1, d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1- 4.250mg/m² ct I.V on w 1-3,d 1.Cycle 3 +:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1-4.~250mg/m² ct I.V on w 1-3,d 1. C:Cycle1:100mg/m² cs I.V on w 1, d 1. 5-FU as a 96-h C.I. of 1000mg/m²/d st on w 1,d 1.400 mg/m² ct I.V on w 2,d 1.250mg/m² ct I.V on w 3&4,d 1.Cycle2-6:100mg/m² cs I.V on w 1,d 1.5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1. 250mg/m² ct I.V w 1,2,&3,d 1.~D:Cycle1:400mg/m² ct I.V w 1,d 1.100mg/m² cs I.V w 1,d 1.Optional 5-FU as a 96-h C.I. of 1000mg/m²/d st w 1,d 1."
896825|NCT01099358|P4|Participant Flow|Cetuximab and Cisplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896826|NCT01099358|P3|Participant Flow|Cetuximab and Cisplatin (C)|"Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896827|NCT01099358|P2|Participant Flow|Cetuximab on Cisplatin (B)|"Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1. After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896828|NCT01099358|P1|Participant Flow|Cisplatin on Cetuximab (A)|"Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1. After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896829|NCT01099358|O1|Outcome|Cetuximab (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1."
896830|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896865|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896866|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896867|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896868|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896869|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896870|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
904939|NCT01075685|O2|Outcome|Minimum Information|
896831|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896832|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896833|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896834|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896835|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896836|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896837|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896871|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896872|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896873|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896874|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896875|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896838|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896839|NCT01099358|O1|Outcome|Cetuximab (B and C)|"Cetuximab on Cisplatin (B) Cycle 1:400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cetuximab and Cisplatin (C) Cycle 1 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 100 mg/m² cisplatin admin I.V on week 1, day 1. 5-FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896840|NCT01099358|O2|Outcome|Cetuximab and Cisplatin (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896841|NCT01099358|O1|Outcome|Cetuximab (A and C)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1."
896842|NCT01099358|E4|Reported Event|Cetuximab and Cisplatin (D)|"Cetuximab and Cisplatin (D)~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m²) cetuximab administered (admin) intravenously (I.V) on week 1, day 1.~100 mg/m² cisplatin administered I.V on week 1, day 1. Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/m²/day (d) administered starting on week 1, day 1.~After 1 cycle, participants may continue treatment as determined by the physician until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896843|NCT01099358|E3|Reported Event|Cetuximab and Cisplatin (C)|"Cetuximab and Cisplatin (C)~Cycle 1 (4 weeks, combination therapy):~100 mg/m² Cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks combination therapy):~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 1, 2, and 3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896844|NCT01099358|E2|Reported Event|Cetuximab on Cisplatin (B)|"Cetuximab on Cisplatin (B)~Cycle 1:~400 mg/m² cetuximab admin I.V on week 1, day 1. 250 mg/m² cetuximab admin I.V on week 2 and 3, day 1.~Cycle 2:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1- 4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~Cycle 3 + :~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on week 1-3, day 1.~After 6 cycles, participants may then receive weekly cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896876|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896877|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896878|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896879|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896880|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896881|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896882|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896883|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896845|NCT01099358|E1|Reported Event|Cisplatin on Cetuximab (A)|"Cisplatin on Cetuximab (A)~Cycle 1:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~400 mg/m² cetuximab admin I.V on week 2, day 1. 250 mg/m² cetuximab admin I.V on week 3, day 1.~Cycle 2 +:~100 mg/m² cisplatin admin I.V on week 1, day 1. 5- FU admin as a 96-hour C.I. of 1000 mg/m²/d admin starting on week 1, day 1-4.~250 mg/m² cetuximab admin I.V on weeks 1-3, day 1.~After 7 cycles, participants may then receive weekly Cetuximab monotherapy until progression of disease, unacceptable toxicity, or another withdrawal criterion is met.~Due to protocol amendment in September 2011, any newly enrolled participants were placed into cetuximab and cisplatin (C) arm only. After protocol amendment February 2014, any newly enrolled participants will be placed into cetuximab and cisplatin (D) arm only."
896846|NCT01099267|B1|Baseline|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896847|NCT01099267|P1|Participant Flow|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896848|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896849|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896850|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896851|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896852|NCT01099267|O1|Outcome|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896853|NCT01099267|E1|Reported Event|Lenalidomide|No intervention was given during this extension study which gathered survival information on participants of study NCT00065156 (Celgene study CC-5013-MDS-003). During the CC-5013-MDS-003 study, participants initially took a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle. The study was amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
896854|NCT01099215|B3|Baseline|Total|Total of all reporting groups
896855|NCT01099215|B2|Baseline|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896856|NCT01099215|B1|Baseline|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896857|NCT01099215|P2|Participant Flow|High Dose PVS-10200 (Cohort B)|High dose PVS-10200 (15×10^5 cells/cm lesion)
896858|NCT01099215|P1|Participant Flow|Low Dose PVS-10200 (Cohort A)|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896859|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896860|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896861|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896862|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896863|NCT01099215|O2|Outcome|Cohort B|High dose PVS-10200 (15×10^5 cells/cm lesion)
896864|NCT01099215|O1|Outcome|Cohort A|Low dose PVS-10200 (6×10^5 cells/cm lesion)
896895|NCT01099202|B1|Baseline|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
896896|NCT01099202|P2|Participant Flow|No Procrit|No intervention.
896897|NCT01099202|P1|Participant Flow|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
896898|NCT01099202|O2|Outcome|No Procrit|No intervention.
896899|NCT01099202|O1|Outcome|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
896900|NCT01099202|O2|Outcome|No Procrit|No intervention.
896901|NCT01099202|O1|Outcome|Procrit|Procrit starting dose 40,000 Units subcutaneously once a week with chemotherapy.
896902|NCT01099202|E2|Reported Event|No Procrit|No intervention.
896903|NCT01099202|E1|Reported Event|Procrit|Starting dose 40,000 Units subcutaneously once a week with chemotherapy.
896904|NCT01099111|B6|Baseline|Total|Total of all reporting groups
896905|NCT01099111|B5|Baseline|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896906|NCT01099111|B4|Baseline|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896907|NCT01099111|B3|Baseline|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896908|NCT01099111|B2|Baseline|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896909|NCT01099111|B1|Baseline|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896910|NCT01099111|P5|Participant Flow|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896911|NCT01099111|P4|Participant Flow|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896952|NCT01098747|B4|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
896953|NCT01098747|B3|Baseline|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
896912|NCT01099111|P3|Participant Flow|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896913|NCT01099111|P2|Participant Flow|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896914|NCT01099111|P1|Participant Flow|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896915|NCT01099111|O5|Outcome|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896916|NCT01099111|O4|Outcome|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896917|NCT01099111|O3|Outcome|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896918|NCT01099111|O2|Outcome|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896919|NCT01099111|O1|Outcome|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896954|NCT01098747|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896955|NCT01098747|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets.
896956|NCT01098747|P4|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
896920|NCT01099111|E5|Reported Event|Control: Normal Subjects|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 22/12/2010, however, in view of insufficient DNA extraction of 6 subjects they have been replaced on 19/09/2012 with other 6 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896921|NCT01099111|E4|Reported Event|Colo Rectal Cancer|"29 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 28/05/2012, and all have been identified as sufficient DNA extraction.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896922|NCT01099111|E3|Reported Event|Crohn's Disease|"46 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 27/05/2012, however, in view of insufficient DNA extraction of 2 subjects they have been replaced on 05/09/2012 with other 2 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896923|NCT01099111|E2|Reported Event|Ulcerative Colitis|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 05/06/2012, however, in view of insufficient DNA extraction of 3 subjects they have been replaced on 16/09/2012 with other 3 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896924|NCT01099111|E1|Reported Event|Irritable Bowel Syndrome|"50 subjects that exactly meet our inclusion & exclusion criteria were recruited. Demographic and clinical data were entered for each during the introduction to the study and verifying acceptance to participate. Then after unified bowel preparation protocol, a full Colonoscopy was performed after signing the consent, during which mucosal washing samples were collected from the unified 4 colonic segment sites, as specified in methodology.~Recruitment were completed on 08/05/2011, however, in view of insufficient DNA extraction of 5 subjects they have been replaced (on 28/07/2012) with other 5 subjects following exactly the same protocol.~Now, all are identified as sufficient DNA extraction and had been enrolled into a comprehensive analysis of the gastrointestinal tract microbiota and its contribution on gut homeostasis by using state of the art metagenomics technology."
896925|NCT01098851|B3|Baseline|Total|Total of all reporting groups
896926|NCT01098851|B2|Baseline|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
896927|NCT01098851|B1|Baseline|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
896928|NCT01098851|P2|Participant Flow|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
896929|NCT01098851|P1|Participant Flow|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
896930|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
896931|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
896932|NCT01098851|O2|Outcome|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
896933|NCT01098851|O1|Outcome|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
896934|NCT01098851|E2|Reported Event|Surgery Patients|Surgery patients at low risk for Obstructive Sleep Apnea
896935|NCT01098851|E1|Reported Event|Obstructive Sleep Apnea|Surgery patients at high risk for Obstructive Sleep Apnea
896936|NCT01098812|B4|Baseline|Total|Total of all reporting groups
896937|NCT01098812|B3|Baseline|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
896938|NCT01098812|B2|Baseline|Toric IOL|Investigational Toric IOL
896939|NCT01098812|B1|Baseline|ZCB00|Approved Intraocular control lens
896940|NCT01098812|P3|Participant Flow|Higher Cylinder Toric IOL|Investigational toric IOLs with higher cylinder powers.
896941|NCT01098812|P2|Participant Flow|Toric IOL|Investigational Toric IOL
896942|NCT01098812|P1|Participant Flow|ZCB00|Approved Intraocular control lens
896943|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
896944|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
896945|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
896946|NCT01098812|O3|Outcome|Higher Cylinder Toric IOL|Investigational Toric IOLs with higher cylinder powers.
896947|NCT01098812|O2|Outcome|Toric IOL|Investigational Toric IOL
896948|NCT01098812|O1|Outcome|Control IOL|Approved Intraocular control lens
896949|NCT01098812|E2|Reported Event|All Toric IOLs|Investigational Toric IOLs including high cylinder powers
896950|NCT01098812|E1|Reported Event|ZCB00|Approved Intraocular control lens
896951|NCT01098747|B5|Baseline|Total|Total of all reporting groups
897007|NCT01098747|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets.
896957|NCT01098747|P3|Participant Flow|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
896958|NCT01098747|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896959|NCT01098747|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets.
896960|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896961|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896962|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896963|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896964|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896965|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896966|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896967|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896968|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896969|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896970|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896971|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896972|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896973|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896974|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896975|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896976|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896977|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896978|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896979|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896980|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896981|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896982|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896983|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896984|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896985|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896986|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896987|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896988|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896989|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896990|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896991|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896992|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896993|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896994|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896995|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896996|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
896997|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
896998|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
896999|NCT01098747|O3|Outcome|Ibuprofen (Advil + Motrin IB)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets or Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets.
897000|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
897001|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
897002|NCT01098747|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
897003|NCT01098747|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets.
897004|NCT01098747|E4|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen [Motrin ibuprofen (IB)] 200 mg tablets (total dose of 400 mg ibuprofen).
897005|NCT01098747|E3|Reported Event|Ibuprofen (Advil)|Single oral dose of 2 ibuprofen (Advil) 200 mg tablets (total dose of 400 mg ibuprofen).
897006|NCT01098747|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 milligram (mg) tablets, equivalent to 400 mg ibuprofen.
897008|NCT01098578|B1|Baseline|Floseal|"Received Floseal treatment for posterior epistaxis.~Floseal : Received Floseal as treatment for posterior epistaxis."
897009|NCT01098578|P1|Participant Flow|Floseal.|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion.
897010|NCT01098578|O2|Outcome|Endoscopic Surgery|The calculated minimal institutional cost if all the study patients had been treated with endoscopic surgery for posterior epistaxis
897011|NCT01098578|O1|Outcome|FLOSEAL|Institutional cost of treating all study patients with Floseal for posterior epistaxis
897012|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
897013|NCT01098578|O1|Outcome|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
897014|NCT01098578|E1|Reported Event|Floseal|Floseal® was used for posterior epistaxis treatment with simultaneous ipsilateral choanal occlusion
897015|NCT01098539|B3|Baseline|Total|Total of all reporting groups
897016|NCT01098539|B2|Baseline|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897017|NCT01098539|B1|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897018|NCT01098539|P2|Participant Flow|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897019|NCT01098539|P1|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897020|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897021|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897022|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897023|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897071|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897257|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897024|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897025|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897026|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897027|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897028|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897029|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897030|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897031|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897032|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897033|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897072|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897034|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897035|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897036|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897037|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897038|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897039|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897040|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897041|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897042|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897043|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897073|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897044|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897045|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897046|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897047|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897048|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897049|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897050|NCT01098539|O2|Outcome|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897051|NCT01098539|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897052|NCT01098539|E2|Reported Event|Sitagliptin 100 mg|Participants with normal renal function (estimated glomerular filtration rate [eGFR] >89 milliliters per minute [mL/min]) received a sitagliptin 100 mg overcoated tablet once daily orally from Baseline until Week 52. The dose of sitagliptin was adjusted in a range of 25-100 mg based on the participant’s severity of renal impairment using the modification of diet in renal disease (MDRD) formula. Participants also received albiglutide matching placebo once weekly subcutaneously from Baseline until Week 52. Albiglutide matching placebo was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897053|NCT01098539|E1|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) once weekly subcutaneously from Baseline until Week 52, with optional up-titration to 50 mg if additional glycemic control was required. Albiglutide was injected subcutaneously into the abdomen, on alternating right and left sides of the body. Participants also received sitagliptin matching placebo once daily orally. Participants who qualified for hyperglycemia rescue, on or after Week 2, continued in the study after rescue and continued to receive study treatment until study completion.
897074|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897054|NCT01098500|B1|Baseline|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897055|NCT01098500|P1|Participant Flow|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897056|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897057|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897058|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897059|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897060|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897061|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897210|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897211|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897062|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897063|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897064|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897065|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897066|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897067|NCT01098500|O1|Outcome|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897068|NCT01098500|E1|Reported Event|TKI Cohort|Adult (age >=18 years) members of the LabRx database (A United States healthcare claims database containing the aggregated health claims experience of the covered lives managed by United Healthcare) with at least two International Classification of Disease (ICD)-9 codes for any cancer within a six-month timeframe and at least one code for an Epidermal Growth Factor Receptor (EGFR) targeted small molecule tyrosine kinase inhibitor (TKI) drug (erlotinib, gefitinib, dasatinib, imatinib, nilotinib, and lapatinib). TKI initiation must have occurred within 30 days prior to or any time after the first cancer diagnosis. The index date was the date of the first TKI prescription, and patients were followed from 30 days prior to the index date through the last visit in the database (which may be due to death or change in health plan), or the study cut-off date of June 1, 2009, whichever came first.
897069|NCT01098487|B1|Baseline|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897070|NCT01098487|P1|Participant Flow|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897212|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897075|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897076|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897077|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897078|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897079|NCT01098487|O1|Outcome|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897080|NCT01098487|E1|Reported Event|Eltrombopag|Participants received an Open-label treatment of eltrombopag administered as a tablet for up to 2 years (104 weeks), followed by a follow-up period of up to 6 months (only 4 weeks for most participants). The starting dose of eltrombopag was 50 milligrams (mg), once daily (QD). East Asian participants started at a dose of 25 mg QD. The maximum dose allowed was 75 mg daily. Dose modifications were allowed based upon each participant’s individual platelet count response.
897081|NCT01098461|B5|Baseline|Total|Total of all reporting groups
897082|NCT01098461|B4|Baseline|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897083|NCT01098461|B3|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897084|NCT01098461|B2|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897085|NCT01098461|B1|Baseline|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897086|NCT01098461|P4|Participant Flow|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897087|NCT01098461|P3|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897088|NCT01098461|P2|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897089|NCT01098461|P1|Participant Flow|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897090|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897091|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897092|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897213|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897258|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897093|NCT01098461|O1|Outcome|Albiglutide 15/30 mg Weekly or 30 mg Every Other Week|Participants received albiglutide 15 mg weekly, 30 mg weekly, or 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897094|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897095|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897096|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897097|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897098|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897099|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897100|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897101|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897102|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897103|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897104|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897105|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897106|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897107|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897108|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897109|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897110|NCT01098461|O4|Outcome|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897111|NCT01098461|O3|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897112|NCT01098461|O2|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897113|NCT01098461|O1|Outcome|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897288|NCT01097863|B4|Baseline|Total|Total of all reporting groups
897114|NCT01098461|E4|Reported Event|Albiglutide 30 mg Every Other Week|Participants received albiglutide 30 mg or matching placebo administered via subcutaneous injection on alternating weeks via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897115|NCT01098461|E3|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897116|NCT01098461|E2|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 milligrams (mg) administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897117|NCT01098461|E1|Reported Event|Placebo|Participants received albiglutide-matching placebo administered via subcutaneous injection once a week via a fully disposable pen injector system for 16 weeks. The preferred post-rescue add-on treatment was insulin. Other medications may have been added at the investigator’s discretion.
897118|NCT01098318|B4|Baseline|Total|Total of all reporting groups
897119|NCT01098318|B3|Baseline|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
897120|NCT01098318|B2|Baseline|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
897121|NCT01098318|B1|Baseline|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
897122|NCT01098318|P3|Participant Flow|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
897123|NCT01098318|P2|Participant Flow|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
897124|NCT01098318|P1|Participant Flow|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
897125|NCT01098318|O3|Outcome|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
897126|NCT01098318|O2|Outcome|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
897127|NCT01098318|O1|Outcome|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
897128|NCT01098318|E3|Reported Event|Sugar Pill|"Lactose monohydrate~Lactose monohydrate: 1-4 capsules daily"
897129|NCT01098318|E2|Reported Event|Sertraline|"Conventional anti-depressant~Sertraline: 50-200 mg daily"
897130|NCT01098318|E1|Reported Event|Rhodiola Rosea|"Herbal extract~Herbal extract: 340-1,360 mg daily"
897131|NCT01098305|B3|Baseline|Total|Total of all reporting groups
897132|NCT01098305|B2|Baseline|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
897133|NCT01098305|B1|Baseline|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
897134|NCT01098305|P2|Participant Flow|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
897135|NCT01098305|P1|Participant Flow|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
897136|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
897137|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
897214|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897966|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897138|NCT01098305|O2|Outcome|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
897139|NCT01098305|O1|Outcome|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
897140|NCT01098305|E2|Reported Event|Placebo|Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
897141|NCT01098305|E1|Reported Event|Varenicline|"Varenicline: Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).~Counseling: All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field."
897142|NCT01098253|B3|Baseline|Total|Total of all reporting groups
897143|NCT01098253|B2|Baseline|Usual Care|
897144|NCT01098253|B1|Baseline|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
897145|NCT01098253|P2|Participant Flow|Usual Care|
897146|NCT01098253|P1|Participant Flow|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
897147|NCT01098253|O2|Outcome|Usual Care|
897148|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
897149|NCT01098253|O2|Outcome|Usual Care|
897150|NCT01098253|O1|Outcome|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
897151|NCT01098253|E2|Reported Event|Usual Care|
897152|NCT01098253|E1|Reported Event|Integrated Care Intervention|We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.
897153|NCT01098240|B1|Baseline|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
897154|NCT01098240|P3|Participant Flow|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897155|NCT01098240|P2|Participant Flow|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg every evening (QPM) for 3 days, then 1 mg twice daily (BID) for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897156|NCT01098240|P1|Participant Flow|Open-Label Antidepressant Treatment (ADT)|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 milligram/day [mg/d]), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine controlled-release (CR) (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
897157|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897158|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897215|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897159|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897160|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897161|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897162|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897163|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897164|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897165|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897166|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897167|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897168|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897169|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897170|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897171|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897172|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897173|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897174|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897175|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897176|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897216|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897177|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897178|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897179|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897180|NCT01098240|O2|Outcome|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897181|NCT01098240|O1|Outcome|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897182|NCT01098240|E3|Reported Event|Placebo + ADT|Placebo matched to CP-601,927 1 mg QPM for 3 days, then CP-601,927 1 mg BID for 3 days, and then CP-601,927 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897183|NCT01098240|E2|Reported Event|CP-601,927 + ADT|Participants treated with CP-601,927 1 mg QPM for 3 days, then 1 mg BID for 3 days, then 2 mg BID on Day 7 of dosing in the double-blind phase. Dose in participants experiencing intolerable nausea may be reduced to 1 mg BID for 6 weeks and a 7-10 day follow-up period. Background ADT (continued from Open-Label ADT) was applied in the double-blind phase.
897184|NCT01098240|E1|Reported Event|Open-Label ADT|Participants treated with 1 of 5 allowed antidepressant agents in accordance with current product labeling, targeting the following doses by the end of week 2: escitalopram (Lexapro) (10-20 mg/d), citalopram (Celexa) (20-40 mg/d), fluoxetine (Prozac, Sarafem) (20-60 mg/d), paroxetine CR (Paxil CR) (37.5-62.5 mg/d), sertraline (Zoloft) (100-200 mg/d), for up to 8 weeks in open-label phase.
897185|NCT01098162|B1|Baseline|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897186|NCT01098162|P1|Participant Flow|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897187|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897188|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897189|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897190|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897191|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897192|NCT01098162|O1|Outcome|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897193|NCT01098162|E1|Reported Event|Vimpat®|Routine treatment in accordance with the local marketing authorization for Vimpat® added to one Baseline antiepileptic drug.
897194|NCT01098110|B4|Baseline|Total|Total of all reporting groups
897195|NCT01098110|B3|Baseline|Placebo BID|Participants received matching placebo BID for 6 weeks.
897196|NCT01098110|B2|Baseline|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897197|NCT01098110|B1|Baseline|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897198|NCT01098110|P3|Participant Flow|Placebo BID|Participants received matching placebo BID for 6 weeks.
897199|NCT01098110|P2|Participant Flow|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897200|NCT01098110|P1|Participant Flow|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet twice daily (BID) for 6 weeks.
897201|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897202|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897203|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897204|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897205|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897206|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897207|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897208|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897209|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897217|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897218|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897219|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897220|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897221|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897222|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897223|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897224|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897225|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897226|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897227|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897228|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897229|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897230|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897231|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897232|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897233|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897234|NCT01098110|O3|Outcome|Placebo BID|Participants received matching placebo BID for 6 weeks.
897235|NCT01098110|O2|Outcome|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897236|NCT01098110|O1|Outcome|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897237|NCT01098110|E3|Reported Event|Placebo BID|Participants received matching placebo BID for 6 weeks.
897238|NCT01098110|E2|Reported Event|Asenapine 10 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID on Day 1, then 10 mg asenapine fast dissolving tablet BID thereafter for a total of 6 weeks.
897239|NCT01098110|E1|Reported Event|Asenapine 5 mg BID|Participants received a 5 mg asenapine fast dissolving tablet BID for 6 weeks.
897240|NCT01098097|B1|Baseline|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897241|NCT01098097|P1|Participant Flow|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897242|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897243|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897244|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897245|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897246|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897247|NCT01098097|O1|Outcome|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897248|NCT01098097|E1|Reported Event|Peginterferon Alpha and Ribavirin|Peginterferon alpha and ribavirin was administered at the discretion of the treating physician, in accordance per label according to local guidelines for all participating countries.
897249|NCT01098071|B1|Baseline|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897250|NCT01098071|P1|Participant Flow|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897251|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897252|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897253|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897254|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897255|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897256|NCT01098071|O1|Outcome|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
904940|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
897259|NCT01098071|E1|Reported Event|Mometasone Furoate Nasal Spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
897260|NCT01098032|B3|Baseline|Total|Total of all reporting groups
897261|NCT01098032|B2|Baseline|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
897262|NCT01098032|B1|Baseline|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
897263|NCT01098032|P2|Participant Flow|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
897264|NCT01098032|P1|Participant Flow|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
897265|NCT01098032|O2|Outcome|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure. Additional doses of furosemide are allowed in case of decrease of urine flow <300 ml/h.
897266|NCT01098032|O1|Outcome|Systemic Alone Therapy Group|Systemic alone therapy grou will be treated by intravenous sodium bicarbonate plus NAC administration. Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. (9) The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days. Additional NAC dose (1.2 g) will be administered i.v. during the procedure.
897267|NCT01098032|E2|Reported Event|Systemic Alone Therapy Group|Systemic alone therapy group was treated by intravenous sodium bicarbonate plus NAC administration.
897268|NCT01098032|E1|Reported Event|RenalGuard System Group|Prophylactic controlled hydration with saline (0.9%) plus N-acetylcystein (NAC; 6 g in total). In the RenalGuard group, an initial bolus (priming) of 250 ml will be administered. In case of left ventricular dysfunction (ejection fraction ≤30%) and/or unstable hemodynamic conditions the bolus will be reduced to 150 ml. Following the initial bolus, furosemide (0.25 mg/kg) will be administered in order to achieve the optimal urine flow (≥300 ml/h). The hydration will be continued throughout the duration of the procedure and will last 4 hours following the procedure.
897269|NCT01097915|B4|Baseline|Total|Total of all reporting groups
897270|NCT01097915|B3|Baseline|Non Tasters|Subjects no sensitive to PROP
897271|NCT01097915|B2|Baseline|Medium Tasters|Subjects sensitive to PROP
897272|NCT01097915|B1|Baseline|Super Tasters|Subjects highly sensitive to PROP
897273|NCT01097915|P3|Participant Flow|Non Tasters|Subjects no sensitive to PROP
897274|NCT01097915|P2|Participant Flow|Medium Tasters|Subjects sensitive to PROP
897275|NCT01097915|P1|Participant Flow|Super Tasters|Subjects highly sensitive to PROP
897276|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
897277|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
897278|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
897279|NCT01097915|O3|Outcome|Non-tasters|Subjects no sensitive to PROP
897280|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
897281|NCT01097915|O1|Outcome|Super-tasters|Subjects highly sensitive to PROP
897282|NCT01097915|O3|Outcome|Non Tasters|Subjects no sensitive to PROP
897283|NCT01097915|O2|Outcome|Medium Tasters|Subjects sensitive to PROP
897284|NCT01097915|O1|Outcome|Super Tasters|Subjects highly sensitive to PROP
897285|NCT01097915|E3|Reported Event|Non Tasters|Subjects no sensitive to PROP
897286|NCT01097915|E2|Reported Event|Medium Tasters|Subjects sensitive to PROP
897287|NCT01097915|E1|Reported Event|Super Tasters|Subjects highly sensitive to PROP
897289|NCT01097863|B3|Baseline|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
897290|NCT01097863|B2|Baseline|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897291|NCT01097863|B1|Baseline|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897292|NCT01097863|P3|Participant Flow|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
897293|NCT01097863|P2|Participant Flow|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897294|NCT01097863|P1|Participant Flow|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897295|NCT01097863|O3|Outcome|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
897296|NCT01097863|O2|Outcome|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897297|NCT01097863|O1|Outcome|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897298|NCT01097863|E3|Reported Event|Nelfilcon A, Inversion Indicator|nelfilcon A commercially marketed contact lenses worn in both eyes on a daily wear, daily disposable basis for one week.
897299|NCT01097863|E2|Reported Event|Nelfilcon A, No Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897300|NCT01097863|E1|Reported Event|Nelfilcon A, Modified Inversion Indicator|nelfilcon A investigational contact lenses worn in both eyes on a daily wear, daily disposable basis for one week
897301|NCT01097785|B3|Baseline|Total|Total of all reporting groups
897302|NCT01097785|B2|Baseline|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
897303|NCT01097785|B1|Baseline|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
897304|NCT01097785|P2|Participant Flow|Placebo, Then Simvastatin|Cycle 1: Participants received Placebo capsule 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Simvastatin 40mg once every day for 30 days.
897305|NCT01097785|P1|Participant Flow|Simvastatin, Then Placebo|Cycle 1: Participants received 40 mg Simvastatin 1 pill every day for 30 days. Cycle 2: Two week washout period. Cycle 3: Placebo pill once every day for 30 days.
897306|NCT01097785|O2|Outcome|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
897307|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
897308|NCT01097785|O2|Outcome|Placebo|Placebo cap 1 pill every day for 30 days
897309|NCT01097785|O1|Outcome|Simvastatin|40 mg Simvastatin 1 pill every day for 30 days
897310|NCT01097785|E2|Reported Event|Placebo|"Placebo cap 1 pill every day for 30 days~Placebo: 1 capsule daily for 30 days"
897311|NCT01097785|E1|Reported Event|Simvastatin|"40 mg Simvastatin 1 pill every day for 30 days~Simvastatin: 40 mg, P.O.,daily for 30 days"
897312|NCT01097694|B3|Baseline|Total|Total of all reporting groups
897313|NCT01097694|B2|Baseline|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897314|NCT01097694|B1|Baseline|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897315|NCT01097694|P2|Participant Flow|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897316|NCT01097694|P1|Participant Flow|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897317|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897318|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897319|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897320|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897321|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897322|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897323|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897324|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897325|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897326|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897327|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897328|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897329|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897330|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897331|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897332|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897333|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897334|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897335|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897336|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897337|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897338|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897339|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897340|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897341|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897342|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897343|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897344|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897345|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897346|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897347|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897348|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897349|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897350|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897351|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897352|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897353|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897354|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897355|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897356|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897357|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897358|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897359|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897400|NCT01097629|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
904941|NCT01075685|E2|Reported Event|Minimum Information|
897360|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897361|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897362|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897363|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897364|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897365|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897366|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897367|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897368|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897369|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897370|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897371|NCT01097694|O2|Outcome|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897372|NCT01097694|O1|Outcome|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897373|NCT01097694|E2|Reported Event|Placebo|"Group on Placebo treatment~Placebo: Placebo"
897374|NCT01097694|E1|Reported Event|Imatinib Mesylate|"Group on active imatinib treatment~Imatinib mesylate: Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur."
897375|NCT01097668|B3|Baseline|Total|Total of all reporting groups
897376|NCT01097668|B2|Baseline|Subcutaneous Injection|Injections of ATX-MS-1467 given by the subcutaneous route
897377|NCT01097668|B1|Baseline|Intradermal Injection|Injections of ATX-MS-1467 given by the intradermal route
897378|NCT01097668|P2|Participant Flow|Subcutaneous Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
897379|NCT01097668|P1|Participant Flow|Intradermal Injection|Upward titration over 4 dose levels (injections of 25, 50, 100 and 400 ug) of ATX MS 1467 followed by injections of 800 ug injected on 5 occasions. All injections were administered at intervals of 14±3 days.
897380|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by subcutaneous route
897381|NCT01097668|O1|Outcome|Intradermal|Injections of ATX-MS-1467 administered by intradermal route
897382|NCT01097668|O2|Outcome|Subcutaneous Injection|Injections of ATX-MS-1467 administered by the subcutaneous route
897383|NCT01097668|O1|Outcome|Intradermal Injection|Injections of ATX-MS-1467 administered by the intradermal route
897384|NCT01097668|E4|Reported Event|Subcutaneous Injection - Non Treatment Emergent|Follow-up period
897385|NCT01097668|E3|Reported Event|Intradermal Injection - Non Treatment Emergent|Follow-up period
897386|NCT01097668|E2|Reported Event|Subcutaneous Injection - Treatment Emergent|Injections will be administered by the subcutaneous route
897387|NCT01097668|E1|Reported Event|Intradermal Injection - Treatment Emergent|Injections will be administered by the intradermal route
897388|NCT01097655|B1|Baseline|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
897389|NCT01097655|P1|Participant Flow|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
897390|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
897391|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
897392|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
897393|NCT01097655|O1|Outcome|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
897394|NCT01097655|E1|Reported Event|HIV-infected Participants|HIV-infected participants starting with Kaletra tablets.
897395|NCT01097629|B4|Baseline|Total|Total of all reporting groups
897396|NCT01097629|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897397|NCT01097629|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897398|NCT01097629|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897399|NCT01097629|P8|Participant Flow|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897401|NCT01097629|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897402|NCT01097629|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897403|NCT01097629|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897404|NCT01097629|P3|Participant Flow|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897405|NCT01097629|P2|Participant Flow|Suvorexant High Dose (HD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897406|NCT01097629|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897407|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897408|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897409|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897410|NCT01097629|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897411|NCT01097629|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897412|NCT01097629|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897413|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897414|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897415|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897416|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897417|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897418|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897419|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897420|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897421|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897422|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897423|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897424|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897425|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897426|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897427|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897428|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897429|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897430|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897431|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897432|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897433|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897434|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897435|NCT01097629|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897436|NCT01097629|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897437|NCT01097629|E16|Reported Event|Placebo (RO, After Placebo in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT and RO Phases.
897438|NCT01097629|E15|Reported Event|Placebo (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT Phase and placebo during RO Phase.
897439|NCT01097629|E14|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT and RO Phases.
897440|NCT01097629|E13|Reported Event|Placebo (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT Phase and placebo during RO Phase.
897441|NCT01097629|E12|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT and RO Phases.
897442|NCT01097629|E11|Reported Event|Placebo (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received placebo during TRT Phase.
897443|NCT01097629|E10|Reported Event|Suvorexant HD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant HD during TRT Phase.
897444|NCT01097629|E9|Reported Event|Suvorexant LD (TRT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT Phase participants who entered Follow-up directly from TRT Phase and had received suvorexant LD during TRT Phase.
897445|NCT01097629|E8|Reported Event|Placebo (RO, After Placebo in TRT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897446|NCT01097629|E7|Reported Event|Placebo (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897447|NCT01097629|E6|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897448|NCT01097629|E5|Reported Event|Placebo (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897449|NCT01097629|E4|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897450|NCT01097629|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month double-blind DB TRT Phase.
897451|NCT01097629|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897452|NCT01097629|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897453|NCT01097616|B4|Baseline|Total|Total of all reporting groups
897454|NCT01097616|B3|Baseline|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897455|NCT01097616|B2|Baseline|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897456|NCT01097616|B1|Baseline|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897457|NCT01097616|P8|Participant Flow|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897458|NCT01097616|P7|Participant Flow|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897682|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897459|NCT01097616|P6|Participant Flow|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897460|NCT01097616|P5|Participant Flow|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897461|NCT01097616|P4|Participant Flow|Suvorexant LD (Run-out [RO], After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897462|NCT01097616|P3|Participant Flow|Placebo (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase, and could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
897463|NCT01097616|P2|Participant Flow|Suvorexant High Dose (HD) (TRT/EXT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
897464|NCT01097616|P1|Participant Flow|Suvorexant Low Dose (LD) (TRT/Extension [EXT] Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase, and could continue on same dose during the optional 3-month DB EXT Phase.
897465|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897466|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897467|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897468|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897469|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897470|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897471|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897472|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897473|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897474|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897475|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897476|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897477|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897478|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897479|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897480|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897481|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897482|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897483|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897484|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897485|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897486|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897634|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897487|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897488|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897489|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897490|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897491|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897492|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897493|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897494|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897495|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897496|NCT01097616|O3|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897497|NCT01097616|O2|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897498|NCT01097616|O1|Outcome|Suvorexant LD|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897499|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897500|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897501|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897502|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897503|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897504|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897505|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897506|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897507|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897508|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897509|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897510|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897511|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897512|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897513|NCT01097616|O2|Outcome|Placebo|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897514|NCT01097616|O1|Outcome|Suvorexant HD|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897515|NCT01097616|E19|Reported Event|Placebo (RO, After Placebo in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received placebo during TRT/EXT and RO Phases.
897516|NCT01097616|E18|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT Phase and placebo during RO Phase.
897681|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897517|NCT01097616|E17|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant HD during TRT/EXT and RO Phases.
897518|NCT01097616|E16|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT Phase and placebo during RO Phase.
897519|NCT01097616|E15|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for RO participants who entered Follow-up from RO Phase, and had received suvorexant LD during TRT/EXT and RO Phases.
897520|NCT01097616|E14|Reported Event|Placebo (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received placebo during TRT/EXT Phase.
897521|NCT01097616|E13|Reported Event|Suvorexant HD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant HD during TRT/EXT Phase.
897522|NCT01097616|E12|Reported Event|Suvorexant LD (TRT/EXT Phase): Follow-up|During 14-day Follow-up after last dose no study drug was administered. Follow-up AE data is presented for TRT/EXT participants who entered Follow-up directly from TRT or EXT Phase and had received suvorexant LD during TRT/EXT Phase.
897523|NCT01097616|E11|Reported Event|Placebo (RO, After Placebo in TRT/EXT)|After receiving placebo to suvorexant during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897524|NCT01097616|E10|Reported Event|Placebo (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897525|NCT01097616|E9|Reported Event|Suvorexant HD (RO, After Suvorexant HD in TRT/EXT)|After receiving suvorexant HD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897526|NCT01097616|E8|Reported Event|Placebo (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received placebo to suvorexant during a 1-week DB RO Phase.
897527|NCT01097616|E7|Reported Event|Suvorexant LD (RO, After Suvorexant LD in TRT/EXT)|After receiving suvorexant LD during the 3-Month DB TRT Phase, and for some participants, the optional 3-Month DB EXT Phase, participants received their same dose of suvorexant during a 1-week DB RO Phase.
897528|NCT01097616|E6|Reported Event|Placebo (EXT Phase)|After receiving placebo to suvorexant during the 3-month DB TRT Phase, participants could continue on placebo to suvorexant during the optional 3-month DB EXT Phase.
897529|NCT01097616|E5|Reported Event|Suvorexant HD (EXT Phase)|After receiving suvorexant HD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
897530|NCT01097616|E4|Reported Event|Suvorexant LD (EXT Phase)|After receiving suvorexant LD during the 3-month DB TRT Phase, participants could continue on same dose during the optional 3-month DB EXT Phase.
897531|NCT01097616|E3|Reported Event|Placebo (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received placebo to suvorexant daily before bedtime during the 3-month DB TRT Phase.
897532|NCT01097616|E2|Reported Event|Suvorexant HD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant HD (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897533|NCT01097616|E1|Reported Event|Suvorexant LD (TRT Phase)|After a 2-week single-blind placebo Run-in, participants received suvorexant LD (20 mg for participants aged 18 to <65 years; and 15 mg for participants aged ≥65 years) daily before bedtime during the 3-month DB TRT Phase.
897534|NCT01096589|B5|Baseline|Total|Total of all reporting groups
897535|NCT01096589|B4|Baseline|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
897536|NCT01096589|B3|Baseline|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897537|NCT01096589|B2|Baseline|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897538|NCT01096589|B1|Baseline|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897539|NCT01096589|P4|Participant Flow|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
897540|NCT01096589|P3|Participant Flow|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897541|NCT01096589|P2|Participant Flow|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897542|NCT01096589|P1|Participant Flow|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897543|NCT01096589|O4|Outcome|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
897544|NCT01096589|O3|Outcome|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897545|NCT01096589|O2|Outcome|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
904942|NCT01075685|E1|Reported Event|Web-based Alcohol Programme|
897546|NCT01096589|O1|Outcome|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897547|NCT01096589|E4|Reported Event|Arm 4 - Commercial Compression System 5 Apps/wk|"Commercial Compression System 5 apps/wk~Short-stretch Bandage (Comprilan; BSN Medical Ltd,). : Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K)."
897548|NCT01096589|E3|Reported Event|Arm 3 - 3M Oedema Reduction System|"3M Oedema Reduction System - 5 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897549|NCT01096589|E2|Reported Event|Arm 2 - 3M Oedema Reduction System|"3M Oedema Reduction System - 3 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897550|NCT01096589|E1|Reported Event|Arm 1 - 3M Oedema Reduction System|"3M Oedema Reduction System - 2 apps/wk~3M Oedema Reduction System (Compression Bandage) : Nonwoven cohesive backing and foam."
897551|NCT01096550|B3|Baseline|Total|Total of all reporting groups
897552|NCT01096550|B2|Baseline|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
897553|NCT01096550|B1|Baseline|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
897554|NCT01096550|P2|Participant Flow|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
897555|NCT01096550|P1|Participant Flow|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
897556|NCT01096550|O2|Outcome|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
897557|NCT01096550|O1|Outcome|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
897558|NCT01096550|E2|Reported Event|Outpatient|"Buprenorphine patients receiving between 2 and 8 hours of outpatient counseling.~Outpatient : Buprenorphine patients receiving 2 to 8 hours of outpatient counseling."
897559|NCT01096550|E1|Reported Event|Intensive Outpatient|"Buprenorphine patients receiving 9 or more hours of outpatient counseling.~Intensive Outpatient : Buprenorphine patients receiving 9 or more hours of outpatient counseling."
897560|NCT01097460|B1|Baseline|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
897561|NCT01097460|P1|Participant Flow|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
897562|NCT01097460|O1|Outcome|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
897563|NCT01097460|E1|Reported Event|MM-111 + Herceptin|"MM-111 will be combined with Herceptin~MM-111 and Herceptin: For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV"
897564|NCT01097421|B1|Baseline|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897565|NCT01097421|P1|Participant Flow|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897566|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897567|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897568|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897569|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897570|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897571|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897572|NCT01097421|O1|Outcome|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897573|NCT01097421|E1|Reported Event|Pramipexole Extended Release|individual doses planned in the range of 0.26 mg (0.375 mg of salt) to 3.15 mg (4.5 mg of salt) of base per day
897574|NCT01097343|B1|Baseline|Cross-over Study|All Study Participants
897575|NCT01097343|P2|Participant Flow|150 mg First 30 Days, Followed by 75 mg|25 patients with the target allele were identified, and received 150 mg clopidogrel followed by 75 mg clopidogrel for two daily for separate dosing periods of 30 days
897576|NCT01097343|P1|Participant Flow|75 mg First 30 Days, Followed by 150 mg|25 patients with the target allele were identified, and receive 75mg followed by 150 mg clopidogrel daily for two separate dosing periods of 30 days
897577|NCT01097343|O2|Outcome|Cross-over Study - 150 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
897578|NCT01097343|O1|Outcome|Cross-over Study- 75 mg Dose|Participants received standard dose clopidogrel (75 mg) and higher dose (150 mg) for 30 days
897579|NCT01097343|E2|Reported Event|150 mg Followed by 75 mg|Cross-over study
897580|NCT01097343|E1|Reported Event|75 mg Followed by 150 mg|Cross-over study
897581|NCT01097304|B1|Baseline|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
897582|NCT01097304|P1|Participant Flow|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
904943|NCT01075646|B5|Baseline|Total|Total of all reporting groups
897583|NCT01097304|O1|Outcome|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
897584|NCT01097304|E1|Reported Event|Treatment (Ursodiol)|"Patients receive ursodiol PO BID for 6 months in the absence of disease progression or unacceptable toxicity.~Ursodiol: Given PO~Laboratory Biomarker Analysis: Correlative studies"
897585|NCT01097005|B1|Baseline|Clarithromycin|Those with an exposure
897586|NCT01097005|P1|Participant Flow|Clarithromycin|Those with an exposure
897587|NCT01097005|O1|Outcome|Clarithromycin|The subjects who completed the study
897588|NCT01097005|O1|Outcome|Clarithromycin|Those with an exposure
897589|NCT01097005|O1|Outcome|Clarithromycin|Negative conversion / Yes
897590|NCT01097005|E1|Reported Event|Clarithromycin|Those with an exposure
897591|NCT01096875|B3|Baseline|Total|Total of all reporting groups
897592|NCT01096875|B2|Baseline|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
897593|NCT01096875|B1|Baseline|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
897594|NCT01096875|P2|Participant Flow|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
897595|NCT01096875|P1|Participant Flow|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
897596|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo: 1tb/day once daily for two weeks prior to surgery"
897597|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
897598|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo: 1tb/day once daily for two weeks prior to surgery"
897599|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin: 40mg/day once daily for two weeks prior to surgery"
897600|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
897601|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
897602|NCT01096875|O2|Outcome|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
897603|NCT01096875|O1|Outcome|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
897604|NCT01096875|E2|Reported Event|Placebo|"Atorvastatin like pill~Placebo : 1tb/day once daily for two weeks prior to surgery"
897605|NCT01096875|E1|Reported Event|Atorvastatin|"Hydroxymethylglutaryl-CoA Reductase Inhibitors~Atorvastatin : 40mg/day once daily for two weeks prior to surgery"
897606|NCT01096823|B3|Baseline|Total|Total of all reporting groups
897607|NCT01096823|B2|Baseline|Waitlist Control|Standard of care waitlist control group
897608|NCT01096823|B1|Baseline|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
897609|NCT01096823|P2|Participant Flow|Waitlist Control|Standard of care waitlist control group
897610|NCT01096823|P1|Participant Flow|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
897611|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
897612|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
897613|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
897614|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
897615|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
897616|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
897617|NCT01096823|O2|Outcome|Waitlist Control|Standard of care waitlist control group
897618|NCT01096823|O1|Outcome|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
897619|NCT01096823|E2|Reported Event|Waitlist Control|Standard of care waitlist control group
897620|NCT01096823|E1|Reported Event|Iyengar Yoga|Iyengar Yoga: Iyengar Yoga classes twice a week for six weeks
897621|NCT01096810|B1|Baseline|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
897622|NCT01096810|P1|Participant Flow|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
897623|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
897624|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
897625|NCT01096810|O1|Outcome|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
897626|NCT01096810|E1|Reported Event|TBL 12|TBL 12, sea cucumber, will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression
897627|NCT01096784|B3|Baseline|Total|Total of all reporting groups
897628|NCT01096784|B2|Baseline|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897629|NCT01096784|B1|Baseline|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897630|NCT01096784|P2|Participant Flow|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897631|NCT01096784|P1|Participant Flow|rhIGF-1/rhIGFBP-3|Participants received insulin-like growth factor (rhIGF-I)/insulin-like growth factor binding protein-3 (rhIGFBP-3) 250 microgram per kilogram (mcg/kg) for 24 hours through continuous intravenous (IV) infusion from Day 0 up to 29 weeks 6 days of post-menstrual age (PMA).
897632|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897633|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
911795|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
897635|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897636|NCT01096784|O2|Outcome|Control|Participants in this control group do not received any treatment other than the standard care.
897637|NCT01096784|O1|Outcome|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897638|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897639|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897640|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897641|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897642|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897643|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897644|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897645|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897646|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897647|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897648|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897649|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897650|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897651|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897652|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897653|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897654|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897655|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897656|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897657|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897658|NCT01096784|O2|Outcome|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897659|NCT01096784|O1|Outcome|rhIGF-1/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897660|NCT01096784|E2|Reported Event|Standard of Care (Control)|Participants in this control group do not received any treatment other than the standard care.
897661|NCT01096784|E1|Reported Event|rhIGF-I/rhIGFBP-3|Participants received rhIGF-I/rhIGFBP-3 250 mcg/kg for 24 hours through continuous IV infusion from Day 0 up to 29 weeks 6 days of PMA.
897662|NCT01096771|B3|Baseline|Total|Total of all reporting groups
897663|NCT01096771|B2|Baseline|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897664|NCT01096771|B1|Baseline|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897665|NCT01096771|P2|Participant Flow|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897666|NCT01096771|P1|Participant Flow|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897667|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897668|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897669|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897670|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897671|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897672|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897673|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897674|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897675|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897676|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897677|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897678|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897679|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897680|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
911796|NCT01055704|O2|Outcome|Codeine 30 mg|
897683|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897684|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897685|NCT01096771|O2|Outcome|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897686|NCT01096771|O1|Outcome|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897687|NCT01096771|E2|Reported Event|Control: Intralipid 20%|Patients received dietary supplement with Intralipid 20%.
897688|NCT01096771|E1|Reported Event|Experimental ClinOleic 20%|Patients received dietary supplement with ClinOleic 20%.
897689|NCT01096680|B6|Baseline|Total|Total of all reporting groups
897690|NCT01096680|B5|Baseline|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897691|NCT01096680|B4|Baseline|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897692|NCT01096680|B3|Baseline|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897693|NCT01096680|B2|Baseline|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897694|NCT01096680|B1|Baseline|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897695|NCT01096680|P5|Participant Flow|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897696|NCT01096680|P4|Participant Flow|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897697|NCT01096680|P3|Participant Flow|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897698|NCT01096680|P2|Participant Flow|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897699|NCT01096680|P1|Participant Flow|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897700|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897701|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897702|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897703|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897704|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897705|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897706|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897707|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897708|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897709|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897710|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897711|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897712|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897713|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897714|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897715|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897716|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897717|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897718|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897719|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897720|NCT01096680|O5|Outcome|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897721|NCT01096680|O4|Outcome|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897722|NCT01096680|O3|Outcome|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897723|NCT01096680|O2|Outcome|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897724|NCT01096680|O1|Outcome|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897725|NCT01096680|E5|Reported Event|Placebo|A single oral dose of placebo administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897726|NCT01096680|E4|Reported Event|Armodafinil 250 mg|A single 250 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897727|NCT01096680|E3|Reported Event|SPD489 70 mg|A single 70 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897728|NCT01096680|E2|Reported Event|SPD489 50 mg|A single 50 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897729|NCT01096680|E1|Reported Event|SPD489 20 mg|A single 20 mg oral dose administered (at approximately 7:25pm) prior to a nocturnal period of sleep deprivation
897730|NCT01096446|B3|Baseline|Total|Total of all reporting groups
897731|NCT01096446|B2|Baseline|Higher Infusion|Infants randomized into the control group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
897732|NCT01096446|B1|Baseline|Standard Infusion|Infants randomized into the experimental group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
897733|NCT01096446|P2|Participant Flow|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
897734|NCT01096446|P1|Participant Flow|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
897735|NCT01096446|O2|Outcome|Standard Infusion|Infants randomized into the control group will receive 0.5 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
897736|NCT01096446|O1|Outcome|Higher Infusion|Infants randomized into the experimental group will receive 2 gm/kg/day of Intravenous Fat Emulsions (IVFE) on their first day of total parenteral nutrition (TPN). The IVFE will be increased by 0.5 gm/kg/day daily until a goal reached of 3 gm/kg/day of IVFE in the TPN.
897737|NCT01096446|E1|Reported Event|Serum Triglycerides|Serum triglycerides <201 mg/dl in both arms were considered to be normal. If serum triglycerides in either arm was above 201 mg/dl than the Intralipids was decreased based on the algorithm for adjusting IVFE when hypertriglyceridemia occured.
897738|NCT01096342|B1|Baseline|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
897739|NCT01096342|P1|Participant Flow|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
897740|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
897741|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
897742|NCT01096342|O1|Outcome|Phase II|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
897743|NCT01096342|E1|Reported Event|Phase II: 50 mg/m^2|Participants were accrued at 50 mg/m^2 dose level after December 30, 2009 addendum. Participants to receive 50 mg/m^2 dinaciclib IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
897744|NCT01096316|B3|Baseline|Total|Total of all reporting groups
897745|NCT01096316|B2|Baseline|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
897746|NCT01096316|B1|Baseline|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
897747|NCT01096316|P2|Participant Flow|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
897748|NCT01096316|P1|Participant Flow|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
897967|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
897749|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
897750|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
897751|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
897752|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
897753|NCT01096316|O2|Outcome|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
897754|NCT01096316|O1|Outcome|Intervention|"The intervention will integrate care between a depression care manager, consulting study team (psychiatry, psychology, OB-GYN researchers) and OB-GYN clinic providers. The 3-part intervention includes:~enhanced education of patients and providers~engagement of patients~depression care management with patient choice of initial antidepressant medication or Problem-Solving Treatment-Primary Care and behavioral activation.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST,"
897755|NCT01096316|E2|Reported Event|Usual Care|Patients randomized to Usual Care Arm will be informed of their diagnosis and encouraged to inform her OB-GYN provider about her depression diagnosis. Patients will be encouraged to proceed with care using any primary care or specialty services normally available to them inside/outside their OB-GYN clinic. All treatment decision for Usual Care Arm patients are left to the OB-GN provider.
897756|NCT01096316|E1|Reported Event|Intervention|"The intervention will integrate care between a depression care manager(DCM), consulting study team (psychiatry OB-GYN physician) and OB-GYN clinic providers.~Depression Care Management: The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). The DCM in a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the 12-month intervention. Patients choose either medication or Problem-Solving Treatment. Depressive symptoms are assessed at each visit with the PHQ-9. Patients with inadequate response after 4 to 8 weeks to the first choice will switch or combine treatments. DCMs partcipate in weekly caseload review with a psychiatrist and Ob-Gyn physician who make treatment recommendations that the DCM then communicates to the patient's own Ob-Gyn physician who writes all prescriptions."
897757|NCT01096186|B1|Baseline|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
897758|NCT01096186|P1|Participant Flow|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
897759|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
897760|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
897761|NCT01096186|O1|Outcome|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
897762|NCT01096186|E1|Reported Event|IPX066|Open-label IPX066 Dose was individualized for each subject in the study. IPX066 doses could be adjusted throughout the study.
897763|NCT01096056|B3|Baseline|Total|Total of all reporting groups
897764|NCT01096056|B2|Baseline|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897765|NCT01096056|B1|Baseline|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897853|NCT01095978|E1|Reported Event|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
897766|NCT01096056|P2|Participant Flow|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897767|NCT01096056|P1|Participant Flow|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897768|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897769|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897770|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897771|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897772|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897773|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897774|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897775|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897776|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897777|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897778|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897779|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897780|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897781|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897782|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897783|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897784|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897785|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897786|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897787|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897788|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897789|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897790|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897791|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897792|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897793|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897794|NCT01096056|O2|Outcome|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897795|NCT01096056|O1|Outcome|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897796|NCT01096056|E2|Reported Event|Influenza Vaccine GSK2186877A Formulation 2 Group|Subjects aged 6 to 35 months received 1 dose of new generation influenza vaccine GSK2186877A formulation 2 at Day 0 and 1 dose of Fluarix vaccine at Month 6.
897797|NCT01096056|E1|Reported Event|Influenza Vaccine GSK2186877A Formulation 1 Group|Subjects aged 6 to 35 months received 2 doses of new generation influenza vaccine GSK2186877A formulation 1 at Day 0 and Day 21 and 1 dose of Fluarix vaccine at Month 6.
897798|NCT01096017|B1|Baseline|All Study Participants|
897799|NCT01096017|P2|Participant Flow|Terbutaline First, Then Salbutamol|Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒Salbutamol pMDI 200 μg +placebo Turbuhaler®
897800|NCT01096017|P1|Participant Flow|Salbutamol First, Then Terbutaline|Salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
897801|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897802|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897803|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897804|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897805|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897806|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897807|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897808|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897809|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897810|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897811|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897812|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897813|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897814|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897815|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897816|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897817|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897818|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897819|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897820|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897821|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897822|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897823|NCT01096017|O2|Outcome|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
897824|NCT01096017|O1|Outcome|Salbutamol pMDI|200 μg, inhalation, single dose
897825|NCT01096017|E2|Reported Event|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose.
897826|NCT01096017|E1|Reported Event|Salbutamol pMDI|200 μg, inhalation, single dose.
897827|NCT01095978|B1|Baseline|Klacid SR|The per-protocol population (2800 participants) with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897828|NCT01095978|P1|Participant Flow|Klacid SR|Participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR
897829|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897830|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897831|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897832|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
897833|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
897834|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897835|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
897836|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
897837|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897838|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
897839|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
897840|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897841|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
897842|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
897843|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897844|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
897845|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
897846|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897847|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
897848|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
897849|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897850|NCT01095978|O3|Outcome|Klacid SR (65 Years of Age or Older)|Participants 65 years of age or older.
897851|NCT01095978|O2|Outcome|Klacid SR (18 to 64 Years of Age)|Participants 18 to 64 years of age.
897852|NCT01095978|O1|Outcome|Klacid SR (Total)|All participants with acute tracheitis, bronchitis, or pneumonia treated with Klacid SR.
897854|NCT01095887|B1|Baseline|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
897855|NCT01095887|P1|Participant Flow|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
897856|NCT01095887|O1|Outcome|Eculizumab|Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.
897857|NCT01095887|E1|Reported Event|Eculizumab|"Eculizumab was given on Day 0, day 1, and weekly for the first four weeks after transplant.~Eculizumab: Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels."
897858|NCT01095835|B4|Baseline|Total|Total of all reporting groups
897859|NCT01095835|B3|Baseline|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897860|NCT01095835|B2|Baseline|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897861|NCT01095835|B1|Baseline|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897862|NCT01095835|P3|Participant Flow|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897863|NCT01095835|P2|Participant Flow|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897864|NCT01095835|P1|Participant Flow|PEG-IFN48|Treatment with pegylated interferon (PEG-IFN) alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897865|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897866|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897867|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897868|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897869|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897870|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897871|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897872|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897873|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897963|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897874|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897875|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897876|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897877|NCT01095835|O1|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897878|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897879|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897880|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897881|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897882|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897883|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897884|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897885|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897886|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897887|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897888|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897889|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897890|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897891|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897892|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897964|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
897965|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
897893|NCT01095835|O3|Outcome|PEG-IFN+LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 mg of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897894|NCT01095835|O2|Outcome|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897895|NCT01095835|O1|Outcome|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897896|NCT01095835|E3|Reported Event|PEG-IFN + LAM96|Treatment with PEG-IFN alfa-2a and lamivudine in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by 48 weeks of only PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg subcutaneously, once weekly and 100 milligrams (mg) of oral lamivudine daily were administered from Week 0 to 48 followed by 135 mcg of only PEG-IFN alfa-2a, subcutaneously, once weekly from Week 49 to 96.
897897|NCT01095835|E2|Reported Event|PEG-IFN96|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks followed by another 48 weeks of PEG-IFN alfa-2a treatment (total 96 weeks of treatment). PEG-IFN alfa-2a 180 mcg was administered subcutaneously, once weekly from Week 0 to 48 followed by 135 mcg of PEG-IFN alfa-2a subcutaneously, once weekly from Week 49 to 96.
897898|NCT01095835|E1|Reported Event|PEG-IFN48|Treatment with PEG-IFN alfa-2a in participants with HBeAg-negative chronic hepatitis B virus for 48 weeks. PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
897899|NCT01095796|B3|Baseline|Total|Total of all reporting groups
897900|NCT01095796|B2|Baseline|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897901|NCT01095796|B1|Baseline|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897902|NCT01095796|P2|Participant Flow|Atripla|Atripla® (efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897903|NCT01095796|P1|Participant Flow|Stribild|Stribild® (elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg) single-tablet regimen (STR) once daily plus placebo to match Atripla once daily prior to bedtime
897904|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897905|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897906|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897907|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897908|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897909|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897910|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897911|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897912|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897913|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897914|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897915|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897916|NCT01095796|O2|Outcome|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897917|NCT01095796|O1|Outcome|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897918|NCT01095796|E2|Reported Event|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet once daily prior to bedtime plus placebo to match Stribild once daily
897919|NCT01095796|E1|Reported Event|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR once daily plus placebo to match Atripla once daily prior to bedtime
897920|NCT01095757|B1|Baseline|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897921|NCT01095757|P1|Participant Flow|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and granulocyte-colony stimulating factor (G-CSF).~Plerixafor : 240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target cluster of differentiation 34 (CD34) cell dose has been reached."
897922|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897923|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897924|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897925|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897926|NCT01095757|O2|Outcome|Lymphoma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897927|NCT01095757|O1|Outcome|Multiple Myeloma|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897928|NCT01095757|E1|Reported Event|Plerixafor + Chemo and G-CSF|"Patients who receive a combination of Plerixafor, chemotherapy and G-CSF.~Plerixafor : 240 µg/kg subcutaneous injection on the day that the ANC is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached."
897929|NCT01095653|B4|Baseline|Total|Total of all reporting groups
897930|NCT01095653|B3|Baseline|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897931|NCT01095653|B2|Baseline|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897932|NCT01095653|B1|Baseline|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897933|NCT01095653|P3|Participant Flow|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897934|NCT01095653|P2|Participant Flow|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897935|NCT01095653|P1|Participant Flow|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897936|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897937|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897938|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897939|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897940|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897941|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897942|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897943|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897944|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897945|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897946|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897947|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897948|NCT01095653|O3|Outcome|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897949|NCT01095653|O2|Outcome|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897950|NCT01095653|O1|Outcome|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897951|NCT01095653|E3|Reported Event|Dapagliflozin 10 mg|Participants received dapagliflozin 10 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897952|NCT01095653|E2|Reported Event|Dapagliflozin 5 mg|Participants received dapagliflozin 5 mg once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897953|NCT01095653|E1|Reported Event|Placebo|Participants received dapagliflozin matching placebo once daily for up to 24 weeks (may include the addition of open-label metformin as rescue)
897954|NCT01095510|B4|Baseline|Total|Total of all reporting groups
897955|NCT01095510|B3|Baseline|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
897956|NCT01095510|B2|Baseline|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897957|NCT01095510|B1|Baseline|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
897958|NCT01095510|P4|Participant Flow|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
897959|NCT01095510|P3|Participant Flow|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897960|NCT01095510|P2|Participant Flow|1000 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897961|NCT01095510|P1|Participant Flow|500 U CINRYZE (10-25 kg Body Weight)|Single intravenous (IV) dose of 500 U CINRYZE
897962|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
897969|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897970|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
897971|NCT01095510|O3|Outcome|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
897972|NCT01095510|O2|Outcome|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897973|NCT01095510|O1|Outcome|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
897974|NCT01095510|E3|Reported Event|1500 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1500 U CINRYZE
897975|NCT01095510|E2|Reported Event|1000 U CINRYZE (>25 kg Body Weight)|Single IV dose of 1000 U CINRYZE
897976|NCT01095510|E1|Reported Event|500 U CINRYZE (10-25 kg Body Weight)|Single IV dose of 500 U CINRYZE
897977|NCT01095497|B3|Baseline|Total|Total of all reporting groups
897978|NCT01095497|B2|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
897979|NCT01095497|B1|Baseline|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of SC CINRYZE twice weekly for two weeks.
897980|NCT01095497|P2|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 2|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of IV CINRYZE twice weekly for two weeks. In Period 2, subjects received 2000 Units of SC CINRYZE twice weekly for two weeks.
897981|NCT01095497|P1|Participant Flow|IV CINRYZE First, Then SC CINRYZE Dose 1|Subjects participated in two 18-day treatment periods, separated by a washout period of at least 14 days. In Period 1, subjects received 1000 Units of intravenous (IV) CINRYZE twice weekly for two weeks. In Period 2, subjects received 1000 Units of subcutaneous (SC) CINRYZE twice weekly for two weeks.
897982|NCT01095497|O3|Outcome|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
897983|NCT01095497|O2|Outcome|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
897984|NCT01095497|O1|Outcome|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
897985|NCT01095497|E3|Reported Event|SC CINRYZE Dose 2|2000 Units of SC CINRYZE twice weekly for two weeks
897986|NCT01095497|E2|Reported Event|SC CINRYZE Dose 1|1000 Units of SC CINRYZE twice weekly for two weeks
897987|NCT01095497|E1|Reported Event|IV CINRYZE|1000 Units of IV CINRYZE twice weekly for two weeks
897988|NCT01095250|B5|Baseline|Total|Total of all reporting groups
897989|NCT01095250|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
897990|NCT01095250|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
897991|NCT01095250|B2|Baseline|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
897992|NCT01095250|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
897993|NCT01095250|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
897994|NCT01095250|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg subcutaneously at baseline and Week 2, then every 4 weeks.
897995|NCT01095250|P2|Participant Flow|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
897996|NCT01095250|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
897997|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
897998|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
897999|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
898000|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
898001|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
898002|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
898003|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
898004|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
898005|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
898006|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
898007|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
898008|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
898009|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
898010|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
898011|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
898012|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
898013|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
898014|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
898015|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
898016|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
898564|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
898017|NCT01095250|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
898018|NCT01095250|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
898019|NCT01095250|O2|Outcome|AIN457 300mg s.c. Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
898020|NCT01095250|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300 mg subcutaneously at baseline, Week 1 and Week 2, then every 2 weeks
898021|NCT01095250|E4|Reported Event|Placebo Every 2 Weeks|Placebo s.c at baseline, Week 1 and Week 2, then every 2 weeks
898022|NCT01095250|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150 mg s.c. at baseline and Week 2, then every 4 weeks
898023|NCT01095250|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300 mg subcutaneously at baseline and Week 2, then every 4 weeks.
898024|NCT01095250|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. at baseline, Week 1 and Week 2, then every 2 weeks
898025|NCT01095094|B1|Baseline|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
898026|NCT01095094|P1|Participant Flow|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
898027|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
898028|NCT01095094|O1|Outcome|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
898029|NCT01095094|E1|Reported Event|Arm I|"Patients receive oral ritonavir and lopinavir twice daily in the absence of disease progression or unacceptable toxicity.~ritonavir : Given orally~lopinavir : Given orally"
898030|NCT01094886|B1|Baseline|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
898031|NCT01094886|P1|Participant Flow|Rivaroxaban|10 mg PO (orally) qd (once daily) for up to 35 days for total hip replacement (THR) and 14 days for total knee replacement (TKR)
898032|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
898033|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
898034|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
898035|NCT01094886|O1|Outcome|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
898036|NCT01094886|E1|Reported Event|Rivaroxaban|10 mg PO qd for up to 35 days for THR and 14 days for TKR
898037|NCT01094808|B4|Baseline|Total|Total of all reporting groups
898038|NCT01094808|B3|Baseline|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898039|NCT01094808|B2|Baseline|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898040|NCT01094808|B1|Baseline|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898041|NCT01094808|P3|Participant Flow|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898042|NCT01094808|P2|Participant Flow|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898043|NCT01094808|P1|Participant Flow|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898044|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898045|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898046|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898047|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898048|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898049|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898050|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898051|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898052|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898053|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898054|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898055|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898056|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898057|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898058|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898059|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898060|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898061|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898062|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898063|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898064|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898065|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898066|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898067|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898068|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898069|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898070|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898071|NCT01094808|O3|Outcome|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898072|NCT01094808|O2|Outcome|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898073|NCT01094808|O1|Outcome|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898074|NCT01094808|E3|Reported Event|Placebo|Subjects randomized to this arm received a single dose of placebo medication orally
898075|NCT01094808|E2|Reported Event|Pregabalin 200 mg|Subjects randomized to this arm received a single dose of pregabalin 200 mg orally
898076|NCT01094808|E1|Reported Event|Pregabalin 75 mg|Subjects randomized to this arm received a single dose of pregabalin 75 mg orally
898077|NCT01094743|B1|Baseline|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
898078|NCT01094743|P1|Participant Flow|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
898079|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
898080|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
898081|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
898082|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
898083|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
898084|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
898085|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
898086|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
898087|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
898088|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
898089|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
898090|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
898091|NCT01094743|O2|Outcome|Lotrafilcon B|All subjects who wore the lotrafilcon B lens; VA measured after one week of daily contact lens wear.
898092|NCT01094743|O1|Outcome|Galyfilcon A Prototype|All subjects who wore the galyfilcon A prototype lens; VA measured after one week of daily contact lens wear.
898093|NCT01094743|E1|Reported Event|Galyfilcon A Prototype Lens / Lotrafilcon B Lens|All enrolled subjects were to wear both lenses through the course of the study.
898094|NCT01094730|B1|Baseline|All Subjects|All enrolled subjects who have the demographic data and worn at least one study lens.
898095|NCT01094730|P2|Participant Flow|Marketed Galyfilcon A/Galyfilcon A Prototype|The marketed galyfilcon A lens worn daily for 12-16 days during the first period then the galyfilcon A prototype lens worn daily for 12-16 days during the second period.
898096|NCT01094730|P1|Participant Flow|Galyfilcon A Prototype/Marketed Galyfilcon A|The galyfilcon A prototype lens worn daily for 12-16 days during the first period then marketed galyfilcon A lens worn daily for 12-16 days during the second period.
898097|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
898098|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
898099|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
898100|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
898101|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicon hydrogel contact lens.
898102|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicon hydrogel contact lens.
898103|NCT01094730|O2|Outcome|Marketed Galyfilcon A Lens|Marketed silicone hydrogel contact lens.
898104|NCT01094730|O1|Outcome|Galyfilcon A Prototype Lens|Experimental silicone hydrogel contact lens.
898105|NCT01094730|E1|Reported Event|All Subjects|All subjects were to wear both lenses during the course of the study.
898106|NCT01094704|B3|Baseline|Total|Total of all reporting groups
898107|NCT01094704|B2|Baseline|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
898108|NCT01094704|B1|Baseline|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
898109|NCT01094704|P2|Participant Flow|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
898110|NCT01094704|P1|Participant Flow|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
898111|NCT01094704|O2|Outcome|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
898112|NCT01094704|O1|Outcome|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
898113|NCT01094704|E2|Reported Event|Hypertonic Saline - 4 Hours|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment four hours post-dose.
898353|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898114|NCT01094704|E1|Reported Event|Hypertonic Saline - 1 Hour|Single dose of hypertonic saline (7%) nebulized followed by MCC/CC assessment one hour post-dose.
898115|NCT01094574|B7|Baseline|Total|Total of all reporting groups
898116|NCT01094574|B6|Baseline|Placebo -Alfentanil - Propanolol|Participants were randomized to receive an intravenous infusion of normal saline, alfentanil, and propanolol on 3 consecutive study days.
898117|NCT01094574|B5|Baseline|Propranolol - Alfentanil - Placebo|Participants were randomized to receive an intravenous infusion of propanolol, alfentanil, and normal saline on 3 consecutive study days.
898118|NCT01094574|B4|Baseline|Alfentanil - Propanolol - Placebo|Participants were randomized to receive an intravenous infusion of alfentanil, propanolol, and normal saline on 3 consecutive study days.
898119|NCT01094574|B3|Baseline|Placebo - Propanolol - Alfentanil|Participants were randomized to receive an intravenous infusion of normal saline, propanolol, and alfentanil on 3 consecutive study days.
898120|NCT01094574|B2|Baseline|Propranolol - Placebo - Alfentanil|Participants were randomized to receive an intravenous infusion of propanolol, normal saline, and alfentanil on 3 consecutive study days.
898121|NCT01094574|B1|Baseline|Alfentanil - Placebo - Propanolol|Participant(s) were randomized to receive an intravenous infusion of alfentanil, normal saline, and propanolol on 3 consecutive study days.
898122|NCT01094574|P6|Participant Flow|Placebo Day 1, Alfentanil Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
898123|NCT01094574|P5|Participant Flow|Propranolol Day 1, Alfentanil Day 2, and Placebo Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 2: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
898124|NCT01094574|P4|Participant Flow|Alfentanil Day 1, Propranolol Day 2, and Palcebo Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
898125|NCT01094574|P3|Participant Flow|Placebo Day 1, Propranolol Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
898126|NCT01094574|P2|Participant Flow|Propranolol Day 1, Placebo Day 2, and Alfentanil Day 3|"Day 1: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~Day 3: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
898127|NCT01094574|P1|Participant Flow|Alfentanil Day 1, Placebo Day 2, and Propranolol Day 3|"Day 1: Experimental inflammation, and tissue injury sites were created an infusion of alfentanil 100ng/ml was administered over 3 hours.~Day 2: Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours.~Day 3: Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump.~On all study days data were collected to measure inflammation, pain response, and cytokine levels locally.~Experimental inflammation and tissue injury sites were used for pain testing to determine heat and mechanical pain threshold.~Interstitial fluid sampling was accomplished with microdialysis. Samples were collected hourly throughout the study day.~Laser doppler evaluation of tissue perfusion was made at baseline and again at hours 1, 2 and 3 following initiation of the infusions."
898490|NCT01093014|B1|Baseline|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
898128|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898129|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898130|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898131|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898132|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898133|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898134|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898135|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898136|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898137|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898138|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898139|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898140|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898141|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898142|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898143|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898144|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898145|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898146|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898147|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898148|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898149|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898150|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898151|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898248|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
898152|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898153|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898154|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898155|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898156|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898157|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898158|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898159|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898160|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898161|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898162|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898163|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898164|NCT01094574|O3|Outcome|Placebo|Experimental inflammation and tissue injury sites were created, an infusion of normal saline was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898165|NCT01094574|O2|Outcome|Propranolol|Experimental inflammation and tissue injury sites were created, an infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898166|NCT01094574|O1|Outcome|Alfentanil|Experimental inflammation, and tissue injury sites were created, an infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump, and data were collected to measure inflammation, pain response, and cytokine levels locally.
898167|NCT01094574|E6|Reported Event|Placebo -Alfentanil - Propanolol|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
898168|NCT01094574|E5|Reported Event|Propranolol - Alfentanil - Placebo|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
898169|NCT01094574|E4|Reported Event|Alfentanil - Propanolol - Placebo|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
898170|NCT01094574|E3|Reported Event|Placebo - Propanolol - Alfentanil|"An infusion of normal saline was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
898171|NCT01094574|E2|Reported Event|Propranolol - Placebo - Alfentanil|"An infusion of propranolol 30ng/ml was administered over 3 hours on study day 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of alfentanil 100ng/ml was administered over 3 hours on study 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
898249|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
898172|NCT01094574|E1|Reported Event|Alfentanil - Placebo - Propanolol|"An infusion of alfentanil 100ng/ml was administered over 3 hours on study 1. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of normal saline was administered over 3 hours on study 2. Data were collected to measure inflammation, pain response, and cytokine levels locally.~An infusion of propranolol 30ng/ml was administered over 3 hours on study day 3. Data were collected to measure inflammation, pain response, and cytokine levels locally."
898173|NCT01094561|B1|Baseline|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
898174|NCT01094561|P1|Participant Flow|Synthetic Human Secretin|"Single arm (open label).~Subjects will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
898175|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
898176|NCT01094561|O1|Outcome|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
898177|NCT01094561|E1|Reported Event|Synthetic Human Secretin|"Single arm (open label).~Synthetic Human Secretin: Twenty five patients will each undergo an S-MRCP and an S-EUS evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg."
898178|NCT01094548|B3|Baseline|Total|Total of all reporting groups
898179|NCT01094548|B2|Baseline|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898180|NCT01094548|B1|Baseline|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898181|NCT01094548|P2|Participant Flow|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898182|NCT01094548|P1|Participant Flow|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898183|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898208|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
898250|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
911797|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
898184|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898185|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898186|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898187|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898188|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898189|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898190|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898191|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at Week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898192|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898247|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
911798|NCT01055704|O4|Outcome|Placebo|
898193|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg/m^2) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898194|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898195|NCT01094548|O2|Outcome|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration in Weeks 1 and 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898196|NCT01094548|O1|Outcome|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898197|NCT01094548|E2|Reported Event|Tecemotide (L-BLP25) Plus Multiple Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving multiple low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide(L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Multiple low dose cyclophosphamide: An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment plus an IV dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide(LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week-14 up to a maximum treatment period of 2 years."
898198|NCT01094548|E1|Reported Event|Tecemotide (L-BLP25) Plus Single Low Dose Cyclophosphamide|"Tecemotide (L-BLP25): After receiving single low dose cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide [L-BLP25]) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy was documented.~Single low dose cyclophosphamide: An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment."
898199|NCT01093222|B1|Baseline|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
898200|NCT01093222|P1|Participant Flow|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
898201|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
898202|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
898203|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
898204|NCT01093222|O1|Outcome|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
898205|NCT01093222|E1|Reported Event|Sorafenib and Erlotinib|Patients receive sorafenib tosylate 400 mg PO twice daily and erlotinib hydrochloride 100 mg PO once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
898206|NCT01094171|B1|Baseline|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
898207|NCT01094171|P1|Participant Flow|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
898209|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
898210|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
898211|NCT01094171|O1|Outcome|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
898212|NCT01094171|E1|Reported Event|Poliorix Group|Subjects received 3 primary doses of Poliorix™ and Infanrix™ vaccines at 3, 4.5 and 6 months of age. All vaccines were administered intramuscularly in the anterolateral side of the left thigh (Poliorix) and the right thigh (Infanrix).
898213|NCT01094119|B3|Baseline|Total|Total of all reporting groups
898214|NCT01094119|B2|Baseline|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
898215|NCT01094119|B1|Baseline|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
898216|NCT01094119|P2|Participant Flow|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
898217|NCT01094119|P1|Participant Flow|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
898218|NCT01094119|O2|Outcome|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
898219|NCT01094119|O1|Outcome|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
898220|NCT01094119|O2|Outcome|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
898221|NCT01094119|O1|Outcome|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
898222|NCT01094119|E2|Reported Event|LMA PerfecTemp System|"Patients will be warmed during surgery with the PerfecTemp heated pad .~heated pad: patients will be warmed with a heated pad during surgery."
898223|NCT01094119|E1|Reported Event|Bair Hugger Heated Blanket|"Patients will be warmed during surgery with the Bair Hugger heated blanket.~heated blanket: heated blanket"
898224|NCT01093976|B1|Baseline|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
898225|NCT01093976|P1|Participant Flow|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
898226|NCT01093976|O1|Outcome|Dronabinol|Dronabinol (Marinol) - 2.5mg-15mg by mouth once a day for twelve-weeks
898227|NCT01093976|E1|Reported Event|Dronabinol|Dronabinol (Marinol) – 2.5mg–15mg by mouth once a day for twelve-weeks
898228|NCT01093846|B4|Baseline|Total|Total of all reporting groups
898229|NCT01093846|B3|Baseline|AIN457 Placebo|
898230|NCT01093846|B2|Baseline|AIN457 300 mg Monthly|300 mg monthly
898231|NCT01093846|B1|Baseline|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
898232|NCT01093846|P3|Participant Flow|AIN457 Placebo|
898233|NCT01093846|P2|Participant Flow|AIN457 300 mg Monthly|300 mg monthly
898234|NCT01093846|P1|Participant Flow|AIN457 300 mg Every 2 Weeks|300 mg every two weeks
898235|NCT01093846|O1|Outcome|Early Termination|
898236|NCT01093846|E3|Reported Event|Placebo|Placebo Safety is provided over the entire treatment period. This includes the core and extension period.
898237|NCT01093846|E2|Reported Event|AIN457 300mg Monthly|AIN457 300mg monthly Safety is provided over the entire treatment period. This includes the core and extension period.
898238|NCT01093846|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks. Safety is provided over the entire treatment period. This includes the core and extension period.
898239|NCT01093794|B1|Baseline|All Participants|
898240|NCT01093794|P4|Participant Flow|4. SitMet850 FDC / Sit + Met500 / Sit + Met850 / SitMet500 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500 mg metformin~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet"
898241|NCT01093794|P3|Participant Flow|3. Sit + Met850 / SitMet850 FDC / SitMet500 FDC / Sit + Met500|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 850 mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 500mg metformin"
898242|NCT01093794|P2|Participant Flow|2. SitMet500 FDC / Sit + Met850 / Sit + Met500 / SitMet850 FDC|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~sitagliptin/metformin 50 mg/500 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin~Co-administration of 50 mg sitagliptin and 500mg metformin~sitagliptin/metformin 50 mg/850 mg FDC tablet"
898243|NCT01093794|P1|Participant Flow|1. Sit + Met500 / SitMet500 FDC / SitMet850 FDC / Sit + Met850|"Participants were administered treatment in the following sequence with a minimum 7 day washout period between treatments:~Co-administration of 50 mg sitagliptin and 500 mg metformin~sitagliptin/metformin 50 mg/500 mg FDC tablet~sitagliptin/metformin 50 mg/850 mg FDC tablet~Co-administration of 50 mg sitagliptin and 850 mg metformin"
898244|NCT01093794|O4|Outcome|SitMet 50mg/850mg FDC|Participants administered sitagliptin/metformin 50 mg/850 mg FDC tablet from all treatment sequences.
898245|NCT01093794|O3|Outcome|Sit 50 mg + Met 850 mg|Participants co-administered 50 mg sitagliptin and 850mg metformin as individual tablets from all treatment sequences.
898246|NCT01093794|O2|Outcome|SitMet 50mg/500mg FDC|Participants administered the sitagliptin/metformin 50 mg/500 mg FDC tablet from all treatment sequences.
898354|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898251|NCT01093794|O1|Outcome|Sit 50 mg + Met 500 mg|Participants co-administered 50 mg sitagliptin and 500 mg metformin as individual tablets from all treatment sequences.
898252|NCT01093794|E4|Reported Event|Sit/Met 50 mg/850 mg FDC|AEs reported in participants after administration of sitagliptin 50 mg/metformin 850 mg FDC tablet.
898253|NCT01093794|E3|Reported Event|Sit 50 mg + Met 850 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 850 mg metformin.
898254|NCT01093794|E2|Reported Event|Sit/Met 50 mg/500 mg FDC|AEs reported in participants after administration of the sitagliptin/metformin 50 mg/500 mg fixed dose combination (FDC) tablet.
898255|NCT01093794|E1|Reported Event|Sit 50 mg + Met 500 mg|AEs reported in participants after co-administration of 50 mg sitagliptin and 500 mg metformin.
898256|NCT01093755|B3|Baseline|Total|Total of all reporting groups
898257|NCT01093755|B2|Baseline|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
898258|NCT01093755|B1|Baseline|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
898259|NCT01093755|P2|Participant Flow|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
898260|NCT01093755|P1|Participant Flow|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
898261|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
898262|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
898263|NCT01093755|O2|Outcome|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
898264|NCT01093755|O1|Outcome|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
898265|NCT01093755|E2|Reported Event|Omeprazole|"Participants will be treated with omeprazole 20mg/day for a minimum of 6 weeks. If symptomatic can increase dose by 20mg twice.~Omeprazole: Escalating doses of omeprazole (20-60 mg/day) for 6 months"
898266|NCT01093755|E1|Reported Event|Dexlansoprazole|"Participants will be treated with dexlansoprazole 60-90 mg/day for 6 months~dexlansoprazole: Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months"
898267|NCT01093690|B3|Baseline|Total|Total of all reporting groups
898268|NCT01093690|B2|Baseline|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
898269|NCT01093690|B1|Baseline|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
898270|NCT01093690|P2|Participant Flow|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
898271|NCT01093690|P1|Participant Flow|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
898272|NCT01093690|O2|Outcome|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
898273|NCT01093690|O1|Outcome|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
898274|NCT01093690|E2|Reported Event|Placebo|ondansetron 8 mg twice a day on days 2-5, dexamethasone 8 mg twice a day on days 2-4 plus placebo 20 mg four times a day on day 2-5
898275|NCT01093690|E1|Reported Event|Metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg orally four times a day on day 2-5
898276|NCT01093651|B3|Baseline|Total|Total of all reporting groups
898277|NCT01093651|B2|Baseline|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898278|NCT01093651|B1|Baseline|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898279|NCT01093651|P2|Participant Flow|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898280|NCT01093651|P1|Participant Flow|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898281|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898282|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898283|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898314|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898284|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898285|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898286|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898287|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898288|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898289|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898290|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898291|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898292|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898293|NCT01093651|O2|Outcome|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898294|NCT01093651|O1|Outcome|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898295|NCT01093651|E2|Reported Event|DPPIV Inhibition|"Four months of sitagliptin administration (100mg/d) to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Sitagliptin : 100 mg sitagliptin daily for 4 months"
898296|NCT01093651|E1|Reported Event|Placebo|"Four months of placebo to people living with HIV-1 who have well-controlled immunologic (CD4+ T-cell count >350 cells/µL) and virologic (plasma HIV RNA <50 copies/mL) status.~Placebo : Daily placebo for 4 months"
898297|NCT01093625|B3|Baseline|Total|Total of all reporting groups
898298|NCT01093625|B2|Baseline|Spectacles|Subjects are randomized to this Control Group.
898299|NCT01093625|B1|Baseline|Investigational Silicone Hydrogel Contact Lens|Subjects randomized to the study arm wearing contact lenses. These subjects are considered neophytes and are non-habitual wearers. Test Group.
898300|NCT01093625|P2|Participant Flow|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898301|NCT01093625|P1|Participant Flow|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898302|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898303|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898304|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898305|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898306|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898307|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898308|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898309|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898310|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898311|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898312|NCT01093625|O2|Outcome|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898313|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898352|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898315|NCT01093625|O1|Outcome|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898316|NCT01093625|E2|Reported Event|Spectacles|Subjects who randomized to this Control Group were non-habitual contact lens wearers and remained to be non-contact lens wearers.
898317|NCT01093625|E1|Reported Event|Investigational Silicone Hydrogel Contact Lens|Subjects who were randomized to the study group wore contact lenses. These subjects were neophytes i.e., non-habitual contact lens wearers at the time of study enrollment.
898318|NCT01093599|B3|Baseline|Total|Total of all reporting groups
898319|NCT01093599|B2|Baseline|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
898320|NCT01093599|B1|Baseline|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
898321|NCT01093599|P2|Participant Flow|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
898322|NCT01093599|P1|Participant Flow|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
898323|NCT01093599|O2|Outcome|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
898324|NCT01093599|O1|Outcome|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
898325|NCT01093599|E2|Reported Event|Quit Line Plus MTS|"Participants in the study group will receive the Quit Line intervention (talk to a Quit Line Counselor, receive quit smoking materials and get 4 weeks of nicotine patches) and also receive 4 weeks of training in mindfulness meditation through the mindfulness for smokers intervention.~Quit Line plus MTS: This provides the quit line intervention plus the Mindfulness for Smokers Intervention."
898326|NCT01093599|E1|Reported Event|Quit Line Only|"Control Participants will call the Wisconsin Tobacco Quit Line intervention including phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.~Quit Line Only: The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches."
898327|NCT01093534|B4|Baseline|Total|Total of all reporting groups
898328|NCT01093534|B3|Baseline|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898329|NCT01093534|B2|Baseline|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898330|NCT01093534|B1|Baseline|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898331|NCT01093534|P3|Participant Flow|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898332|NCT01093534|P2|Participant Flow|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898333|NCT01093534|P1|Participant Flow|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898334|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898335|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898336|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898337|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898338|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898339|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898340|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898341|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898342|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898343|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898344|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898345|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898346|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898347|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898348|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898349|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898350|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898351|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898355|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898356|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898357|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898358|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898359|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898360|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898361|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898362|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898363|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898364|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898365|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898366|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898367|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898368|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898369|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898370|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898371|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898372|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898373|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898374|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898375|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898376|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898377|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898378|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898379|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898380|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898381|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898382|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898383|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898384|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898385|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898386|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898387|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898388|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898389|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898390|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898391|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898392|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898393|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898394|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898395|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898396|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898397|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898398|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898399|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898400|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898401|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898402|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898403|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898404|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898405|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898406|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898407|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898408|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898409|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898410|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898411|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898412|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898413|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898414|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898415|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898416|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898417|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898418|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898419|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898420|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898421|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898422|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898423|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898424|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898425|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898426|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898427|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898428|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898429|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898430|NCT01093534|O4|Outcome|Pooled Solifenacin|Participants received either 5 mg or 10 mg solifenacin once daily for 12 weeks.
898431|NCT01093534|O3|Outcome|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898432|NCT01093534|O2|Outcome|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898433|NCT01093534|O1|Outcome|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898434|NCT01093534|E3|Reported Event|Solifenacin 10 mg|Participants received two 5 mg solifenacin tablets once daily for 12 weeks.
898435|NCT01093534|E2|Reported Event|Solifenacin 5 mg|Participants received one 5 mg solifenacin tablet and one placebo tablet, once daily for 12 weeks.
898436|NCT01093534|E1|Reported Event|Placebo|Participants received 2 placebo tablets once daily for 12 weeks.
898437|NCT01093521|B1|Baseline|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898438|NCT01093521|P1|Participant Flow|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898439|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898440|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898441|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898442|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898443|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898444|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898445|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898446|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898447|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898448|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898449|NCT01093521|O2|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 200 mg/m2/day"
898450|NCT01093521|O1|Outcome|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day"
898451|NCT01093521|E1|Reported Event|IV Gallium (Ganite®) Infusion|"Five day continuous IV Gallium (Ganite®)infusion~IV Gallium Nitrate (Ganite®) infusion: 5 day infusion of gallium nitrate (IV Ganite®) at a doses of 100 mg/m2/day and 200 mg/m2/day and 5 day infusion of gallium nitrate (IV Ganite®) 100 mg/m2/day and 200 mg/m2/day"
898452|NCT01093469|B4|Baseline|Total|Total of all reporting groups
898453|NCT01093469|B3|Baseline|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
898454|NCT01093469|B2|Baseline|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
898455|NCT01093469|B1|Baseline|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
898456|NCT01093469|P3|Participant Flow|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
898457|NCT01093469|P2|Participant Flow|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
898458|NCT01093469|P1|Participant Flow|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
898459|NCT01093469|O3|Outcome|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
898460|NCT01093469|O2|Outcome|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
898461|NCT01093469|O1|Outcome|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
898462|NCT01093469|E3|Reported Event|EpiCream Skin Barrier Emulsion|EpiCream Skin Barrier Emulsion three times daily to atopic dermatitis
898463|NCT01093469|E2|Reported Event|Atopiclair Nonsteroidal Cream|Atopiclair Nonsteroidal Cream three times daily to atopic dermatitis
898464|NCT01093469|E1|Reported Event|Aquaphor Healing Ointment|Aquaphor Healing Ointment three times daily to atopic dermatitis
898465|NCT01093417|B3|Baseline|Total|Total of all reporting groups
898466|NCT01093417|B2|Baseline|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
898467|NCT01093417|B1|Baseline|Placebo|15 participants were randomized to matching placebo for 12 weeks
898468|NCT01093417|P2|Participant Flow|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
898469|NCT01093417|P1|Participant Flow|Placebo|15 participants were randomized to matching placebo for 12 weeks
898470|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
898471|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
898472|NCT01093417|O2|Outcome|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
898473|NCT01093417|O1|Outcome|Placebo|15 participants were randomized to matching placebo for 12 weeks
898474|NCT01093417|E2|Reported Event|Vitamin D 4000 IU|30 participants were randomized to 4000IU of cholecalciferol (vitamin D3) daily for 12 weeks
898475|NCT01093417|E1|Reported Event|Placebo|15 participants were randomized to matching placebo for 12 weeks
898476|NCT01093027|B3|Baseline|Total|Total of all reporting groups
898477|NCT01093027|B2|Baseline|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
898478|NCT01093027|B1|Baseline|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
898479|NCT01093027|P2|Participant Flow|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
898480|NCT01093027|P1|Participant Flow|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
898481|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
898482|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
898483|NCT01093027|O2|Outcome|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
898484|NCT01093027|O1|Outcome|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
898485|NCT01093027|E2|Reported Event|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
898486|NCT01093027|E1|Reported Event|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
898487|NCT01093014|B4|Baseline|Total|Total of all reporting groups
898488|NCT01093014|B3|Baseline|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
898489|NCT01093014|B2|Baseline|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
911799|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
898491|NCT01093014|P3|Participant Flow|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
898492|NCT01093014|P2|Participant Flow|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
898493|NCT01093014|P1|Participant Flow|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
898494|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
898495|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
898496|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
898497|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
898498|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
898499|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
898500|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
898501|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
898502|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
898503|NCT01093014|O3|Outcome|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
898504|NCT01093014|O2|Outcome|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
898505|NCT01093014|O1|Outcome|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation: Electrical stimulation of paralyzed muscle to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
898506|NCT01093014|E3|Reported Event|Arm 3: Sequential Low-force and High-force Muscle Stimulation|Sequential low-force and high-force muscle stimulation
898507|NCT01093014|E2|Reported Event|Arm 2: Low-force Muscle Stimulation|Low-force muscle stimulation
898508|NCT01093014|E1|Reported Event|Arm 1: High-force Muscle Stimulation|High-force muscle stimulation
898509|NCT01092923|B3|Baseline|Total|Total of all reporting groups
898510|NCT01092923|B2|Baseline|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
898511|NCT01092923|B1|Baseline|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
898512|NCT01092923|P2|Participant Flow|Sevoflurane in N2O/O2|Sevoflurane in 2:1 N2O/O2
898513|NCT01092923|P1|Participant Flow|Air/Oxygen|Sevoflurane with Air/Oxygen Mix
898514|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|sevoflurane in air/O2 mix
898515|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|sevoflurane with N20 and Oxygen in 2:1 mix
898516|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
898517|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
898518|NCT01092923|O2|Outcome|Sevoflurane in Air/O2|Air/Oxygen and Sevoflurane
898519|NCT01092923|O1|Outcome|Sevoflurane in N2O/O2|N20 with Oxygen (2:1) and Sevoflurane
898520|NCT01092923|E1|Reported Event|N20 With Oxygen (2:1)|sevoflurane with N20 and Oxygen in 2:1 mix
898521|NCT01092910|B1|Baseline|Esteem Implant|Subjects implanted with the Esteem Totally Implantable Hearing System
898522|NCT01092910|P1|Participant Flow|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898523|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898524|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898525|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898526|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898527|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898528|NCT01092910|O1|Outcome|Esteem Implant|"Subjects are implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898529|NCT01092910|O1|Outcome|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898530|NCT01092910|E1|Reported Event|Esteem Implant|"Subjects implanted with the Esteem Totally Implantable Hearing System~Esteem Totally Implantable Hearing System: The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin."
898531|NCT01092832|B3|Baseline|Total|Total of all reporting groups
898532|NCT01092832|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898533|NCT01092832|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898534|NCT01092832|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898535|NCT01092832|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) with invasive candidiasis/candidemia (ICC) received a loading dose of voriconazole 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with esophageal candidiasis (EC) received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to oral (PO) therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898536|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898537|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898538|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898539|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898560|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
898561|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
898562|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
898563|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
898540|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898541|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898542|NCT01092832|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898543|NCT01092832|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898544|NCT01092832|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) with ICC received a loading dose of voriconazole 6 mg/kg, IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 4 mg/kg, IV, q12h for a minimum of 7 days of IV therapy. Participants with EC received voriconazole 3 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 200 mg, PO, q12h. Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898545|NCT01092832|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to <12 years (and young adolescents aged 12 to 14 years weighing <50 kg) with ICC received a loading dose of voriconazole 9 mg/kg), IV, q12h for the first 24 hours, followed by maintenance dosing of voriconazole 8 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. Participants with EC received voriconazole 4 mg/kg, IV, q12h for a minimum of 5 days of IV therapy. In both ICC and EC, once signs and symptoms of Candida infection had resolved and the participant was clinically stable, participants were switched to PO therapy and received voriconazole 9 mg/kg, PO, q12h (maximum dose of 350 mg). Voriconazole was administered for at least 7 days (participants with EC) or 14 days (participants with ICC) after last positive blood culture up to a maximum of 42 days of treatment.
898546|NCT01092780|B1|Baseline|All Randomized Participants|All participants who were randomized in the study.
898547|NCT01092780|P4|Participant Flow|Pbo/Modafinil/MK-7288 10 mg/MK-7288 20mg|Participants received single doses of study drug in the following order: Placebo in Treatment Period 1, Modafinil 200 mg in Treatment Period 2, MK-7288 10 mg in Treatment Period 3 and MK-7288 20 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
898548|NCT01092780|P3|Participant Flow|Modafinil/MK-7288 20mg/Pbo/MK-7288 10mg|Participants received single doses of study drug in the following order: Modafinil 200 mg in Treatment Period 1, MK-7288 20 mg in Treatment Period 2, Placebo in Treatment Period 3 and MK-7288 10 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
898549|NCT01092780|P2|Participant Flow|MK-7288 20mg/MK-7288 10mg/Modafinil/Pbo|Participants received single doses of study drug in the following order: MK-7288 20 mg in Treatment Period 1, MK-7288 10 mg in Treatment Period 2, Modafinil 200 mg in Treatment Period 3 and Placebo in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
898550|NCT01092780|P1|Participant Flow|MK-7288 10mg/Pbo/MK-7288 20mg/Modafinil|Participants received single doses of study drug in the following order: MK-7288 10 mg in Treatment Period 1, Placebo (Pbo) in Treatment Period 2, MK-7288 20 mg in Treatment Period 3 and Modafinil 200 mg in Treatment Period 4. The first 3 treatment periods were followed by a 7-day washout period.
898551|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
898552|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
898553|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
898554|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
898555|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
898556|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
898557|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
898558|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
898559|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
898565|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
898566|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
898567|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
898568|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
898569|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
898570|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
898571|NCT01092780|O4|Outcome|Placebo|Participants received single doses of Placebo.
898572|NCT01092780|O3|Outcome|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
898573|NCT01092780|O2|Outcome|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
898574|NCT01092780|O1|Outcome|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
898575|NCT01092780|E4|Reported Event|Placebo|Participants received single doses of Placebo.
898576|NCT01092780|E3|Reported Event|Modafinil 200 mg|Participants received single doses of Modafinil 200 mg.
898577|NCT01092780|E2|Reported Event|MK-7288 20 mg|Participants received single doses of MK-7288 20 mg.
898578|NCT01092780|E1|Reported Event|MK-7288 10 mg|Participants received single doses of MK-7288 10 mg.
898579|NCT01092767|B1|Baseline|Valiant Thoracic Stent Graft With the Captivia Delivery System|
898580|NCT01092767|P1|Participant Flow|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
898581|NCT01092767|O1|Outcome|Valiant Thoracic Stent Graft With the Captivia Delivery System|Valiant Thoracic Stent Graft with the Captivia Delivery System : All subjects will be implanted with this device
898582|NCT01092767|E1|Reported Event|1. Rescue|Rescue
898583|NCT01092728|B3|Baseline|Total|Total of all reporting groups
898584|NCT01092728|B2|Baseline|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898585|NCT01092728|B1|Baseline|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898586|NCT01092728|P2|Participant Flow|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898587|NCT01092728|P1|Participant Flow|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898588|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898589|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898590|NCT01092728|O2|Outcome|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898591|NCT01092728|O1|Outcome|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898592|NCT01092728|E2|Reported Event|Dasatinib + Unresectable|Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898593|NCT01092728|E1|Reported Event|Dasatinib + Completely Resectable|Participants will receive Dasatinib 100 mg daily for 7 days. Surgical Tumor Resection on Day 8. Afterwards, Dasatinib 100 mg daily will be administered for a total of 12 months/12 cycles (1 cycle = 4 weeks of treatment).
898594|NCT01092702|B1|Baseline|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
898595|NCT01092702|P1|Participant Flow|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
898596|NCT01092702|O1|Outcome|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
898597|NCT01092702|E1|Reported Event|Varenicline|Everyone on study received Varenicline (2 mg/day) daily for 12 weeks
898598|NCT01092663|B3|Baseline|Total|Total of all reporting groups
898599|NCT01092663|B2|Baseline|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
898600|NCT01092663|B1|Baseline|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
898601|NCT01092663|P2|Participant Flow|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898602|NCT01092663|P1|Participant Flow|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898603|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898604|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898605|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
900645|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
898756|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
898606|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898607|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898608|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898609|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898610|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898611|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898612|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898613|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898614|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898615|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin/day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898616|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898617|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898618|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898619|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898620|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898621|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898622|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898623|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898624|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898625|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898626|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898627|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898628|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898629|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898630|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898631|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.~Sitagliptin: In addition subjects were given 100mg sitagliptin per day. Subjects were given 1 tablet (100mg) with breakfast for 12 weeks."
898632|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelem per day: 3 tablets (625mg each) with breakfast and 3 tablets with dinner for 12 weeks.
898633|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
898634|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
911800|NCT01055704|O2|Outcome|Codeine 30 mg|
898635|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
898636|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
898637|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
898638|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
898639|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100 mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
898640|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
898641|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
898642|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
898643|NCT01092663|O2|Outcome|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.~Sitagliptin: Subjects were given 100mg sitagliptin per day: 1 tablet (100mg) with breakfast for 12 weeks."
898644|NCT01092663|O1|Outcome|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
898645|NCT01092663|E2|Reported Event|Colesevelam Plus Sitagliptin|"Colesevelam: Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.~Sitagliptin: Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks."
898646|NCT01092663|E1|Reported Event|Colesevelam|Subjects were given 3.75 g colesevelam per day: 3 tablets (625mg each) with breakfast and 3 tablets (625mg each) with dinner for 12 weeks.
898647|NCT01092637|B3|Baseline|Total|Total of all reporting groups
898648|NCT01092637|B2|Baseline|Non-cooled|Child was allocated standard intensive care only within 6 hours of birth
898649|NCT01092637|B1|Baseline|Cooled|Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth
898650|NCT01092637|P2|Participant Flow|Non-cooled|"Child was allocated standard intensive care only within 6 hours of birth. Normothermia was maintained throughout.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
898651|NCT01092637|P1|Participant Flow|Cooled|"Child was allocated standard intensive care plus moderate whole body hypothermia treatment within 6 hours of birth. Cooling lasted for 72 hours then gradually rewarmed, after which normothermia was maintained.~Between age 6 yr and 7 yr 3m child and family invited to participate in follow-up study.~Questionnaire data collected from Parent(s) and Teacher(s). Paediatrician and Psychologist visited child in school or at home. Paediatrician neurodevelopmental examination completed and documented on Paediatrician Questionnaire.~Psychologist completed the following tests:~Wechsler Pre-School and Primary Scale of Intelligence Third edition (WPPSI III)~NEPSY II selected sub-tests~Working Memory Test Battery for Children (WMTB-C)~Assessors were blinded to original trial treatment allocation."
898652|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
898653|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
898654|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
898655|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
898656|NCT01092637|O2|Outcome|Non-cooled|Allocated standard treatment (normothermia) at randomization to original trial. See full description in Participant flow section.
898657|NCT01092637|O1|Outcome|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
898658|NCT01092637|E2|Reported Event|Non-cooled|Allocated standard treatment (normothermia) at randomization. See full description in Participant flow section.
898659|NCT01092637|E1|Reported Event|Cooled|Allocated cooling treatment at randomization to original trial. See full description in Participant flow section.
898660|NCT01092559|B1|Baseline|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide via GeNO Nitrosyl System
898661|NCT01092559|P1|Participant Flow|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
898662|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
898663|NCT01092559|O1|Outcome|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
898664|NCT01092559|E1|Reported Event|Nitric Oxide Via GeNO Nitrosyl System|Nitric Oxide generated by the GeNO nitrosyl delivery system : single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
898665|NCT01092546|B1|Baseline|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
898666|NCT01092546|P1|Participant Flow|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
898667|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
898668|NCT01092546|O1|Outcome|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects received an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
898669|NCT01092546|E1|Reported Event|Arm 1-Flutemetamol Injection|[18F]Flutemetamol : All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
898670|NCT01092507|B3|Baseline|Total|Total of all reporting groups
898671|NCT01092507|B2|Baseline|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898672|NCT01092507|B1|Baseline|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898673|NCT01092507|P2|Participant Flow|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898674|NCT01092507|P1|Participant Flow|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898675|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898676|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898677|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898678|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898679|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898680|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898681|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898682|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898683|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898684|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898685|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898686|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898687|NCT01092507|O2|Outcome|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898688|NCT01092507|O1|Outcome|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898689|NCT01092507|E2|Reported Event|Japanese Encephalitis Live Vaccine (SA14-14-2)|Participants received a single dose of Japanese encephalitis live vaccine (SA14-14-2; CD.JEVAX®) on Day 0.
898690|NCT01092507|E1|Reported Event|Japanese Encephalitis Chimeric Vaccine (JE-CV)|Participants received a single dose of Japanese encephalitis chimeric vaccine (JE-CV) on Day 0.
898691|NCT01092442|B3|Baseline|Total|Total of all reporting groups
898692|NCT01092442|B2|Baseline|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
898693|NCT01092442|B1|Baseline|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
898694|NCT01092442|P2|Participant Flow|Prospective Patients|Prospective Patients: The patient group that had the CryoValve SG Pulmonary Human Heart Valve implanted after the February 2008 clearance of the valve.
898695|NCT01092442|P1|Participant Flow|Retrospective Patients|Retrospective Patients: These patients had the CryoValve SG Pulmonary Valve implanted prior to the February 2008 clearance of the valve.
898696|NCT01092442|O2|Outcome|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
898697|NCT01092442|O1|Outcome|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
898698|NCT01092442|O4|Outcome|Prospective RVOT|
898699|NCT01092442|O3|Outcome|Retrospective RVOT|
898700|NCT01092442|O2|Outcome|Prospective Ross|
898701|NCT01092442|O1|Outcome|Retrospective Ross|
898702|NCT01092442|O4|Outcome|Prospective RVOT|
898703|NCT01092442|O3|Outcome|Retrospective Right Ventricular Outflow Tract (RVOT)|
898704|NCT01092442|O2|Outcome|Prospective Ross|
898705|NCT01092442|O1|Outcome|Retrospective Ross|
898706|NCT01092442|E2|Reported Event|RVOT Reconstruction Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted for RVOT reconstruction procedures
898707|NCT01092442|E1|Reported Event|Ross Patients|Retrospective and Prospective Patients that had the CryoValve SG Pulmonary Human Heart Valve implanted as a part of the Ross Procedure
898708|NCT01092416|B1|Baseline|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
898709|NCT01092416|P1|Participant Flow|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
898710|NCT01092416|O1|Outcome|OAS Treatment Group|Subjects enrolled in ORBIT II study and in whom the atherectomy device was inserted.
898711|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
898712|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
898713|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study
898714|NCT01092416|O1|Outcome|ORBIT II Subjects|Subjects enrolled in ORBIT II study.
898715|NCT01092416|E2|Reported Event|ORBIT II Subjects - 1 Year Results|Serious Adverse Events reported from 31 Days to 1 Year Post-Procedure for Subjects enrolled in ORBIT II study.
898716|NCT01092416|E1|Reported Event|ORBIT II Subjects - 30 Day Results|Serious Adverse Events reported out to 30 Days Post-Procedure for Subjects enrolled in ORBIT II study.
898717|NCT01092338|B3|Baseline|Total|Total of all reporting groups
898718|NCT01092338|B2|Baseline|7000IU/d Vitamin D3|
898719|NCT01092338|B1|Baseline|4000IU/d of Vitamin D3|
898720|NCT01092338|P2|Participant Flow|7000IU/d Vitamin D3|
898721|NCT01092338|P1|Participant Flow|4000IU/d of Vitamin D3|
898722|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
898723|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
898724|NCT01092338|O2|Outcome|7000IU/d Vitamin D3|
898725|NCT01092338|O1|Outcome|4000IU/d of Vitamin D3|
898726|NCT01092338|E2|Reported Event|7000IU/d Vitamin D3|
898727|NCT01092338|E1|Reported Event|4000IU/d of Vitamin D3|
898728|NCT01091974|B5|Baseline|Total|Total of all reporting groups
898729|NCT01091974|B4|Baseline|4 - Armodafinil Only|"Armodafinil only~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)"
898730|NCT01091974|B3|Baseline|3 - Placebo Only|"Placebo only~Placebo Comparator: Placebo for 47 days"
898731|NCT01091974|B2|Baseline|2 - CBT-I + Armodafinil|"CBT-I + Armodafinil~armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898732|NCT01091974|B1|Baseline|1 - CBT-I + Placebo|"CBT-I and placebo~Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898733|NCT01091974|P4|Participant Flow|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
898734|NCT01091974|P3|Participant Flow|3- Placebo Only|Placebo Comparator: Placebo for 47 days
898735|NCT01091974|P2|Participant Flow|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898736|NCT01091974|P1|Participant Flow|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898737|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
898738|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
898739|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898740|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898741|NCT01091974|O4|Outcome|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
898742|NCT01091974|O3|Outcome|3- Placebo Only|Placebo Comparator: Placebo for 47 days
898743|NCT01091974|O2|Outcome|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898744|NCT01091974|O1|Outcome|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898745|NCT01091974|E4|Reported Event|4 - Armodafinil Only|Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
898746|NCT01091974|E3|Reported Event|3- Placebo Only|Placebo Comparator: Placebo for 47 days
898747|NCT01091974|E2|Reported Event|2 - CBT-I + Armodafinil|"Armodafinil: Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898748|NCT01091974|E1|Reported Event|Arm 1 - (CBT-I) + Placebo|"Placebo Comparator: Placebo for 47 days~CBT-I: Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)"
898749|NCT01091948|B3|Baseline|Total|Total of all reporting groups
898750|NCT01091948|B2|Baseline|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
898751|NCT01091948|B1|Baseline|Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Intubation with Fiberoptic laryngoscope: Subjects will be intubated with the Fiberoptic laryngoscope."
898752|NCT01091948|P2|Participant Flow|GlideScope® Video Laryngoscope|"Subjects will be intubated with the GlideScope® Video Laryngoscope.~GlideScope® Video Laryngoscope: Patients will be intubated with the GlideScope® Video Laryngoscope."
898753|NCT01091948|P1|Participant Flow|Active Comparator: Fiberoptic Intubation|"Subjects will be intubated with the Fiberoptic laryngoscope.~Active Comparator: GlideScope® Video Laryngoscope Subjects will be intubated with the GlideScope® Video Laryngoscope"
898754|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
898755|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
911801|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
898757|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
898758|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
898759|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
898760|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
898761|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
898762|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
898763|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
898764|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
898765|NCT01091948|O1|Outcome|Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
898766|NCT01091948|O2|Outcome|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
898767|NCT01091948|O1|Outcome|Active Comparator: Fiberoptic Intubation|Subjects will be intubated with the Fiberoptic laryngoscope.
898768|NCT01091948|E2|Reported Event|GlideScope® Video Laryngoscope|Subjects will be intubated with the GlideScope® Video Laryngoscope
898769|NCT01091948|E1|Reported Event|Fiberoptic|Subjects will be intubated with the Fiberoptic laryngoscope.
898770|NCT01091675|B1|Baseline|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
898771|NCT01091675|P1|Participant Flow|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
898772|NCT01091675|O1|Outcome|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
898773|NCT01091675|E1|Reported Event|Etoricoxib|"All the patients who fulfil the eligibility criteria will start a 4-week open label treatment period to evaluate the response to treatment with etoricoxib 90 mg.~Etoricoxib: Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks."
898774|NCT01091662|B3|Baseline|Total|Total of all reporting groups
898775|NCT01091662|B2|Baseline|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepineacetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898776|NCT01091662|B1|Baseline|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
898777|NCT01091662|P2|Participant Flow|ESL1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898778|NCT01091662|P1|Participant Flow|ESL 1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18..
898779|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898780|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
898781|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898782|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898783|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898784|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898785|NCT01091662|O2|Outcome|ESL 1600 mg|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898786|NCT01091662|O1|Outcome|ESL1200 mg|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898787|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898788|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
898789|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898790|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
900646|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
899674|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
898791|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898792|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
898793|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898794|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
898795|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898796|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
898797|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898798|NCT01091662|O1|Outcome|ESL 1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
898799|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898800|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898801|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898802|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898803|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898804|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898805|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898806|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898807|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898808|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898809|NCT01091662|O2|Outcome|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
898810|NCT01091662|O1|Outcome|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
898811|NCT01091662|E2|Reported Event|ESL 1600 mg|Titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after end of Week 18.
898812|NCT01091662|E1|Reported Event|ESL1200 mg|Titrate from 400 mg (Week 1) to 800 mg (Week2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after end of Week 18.
898813|NCT01091519|B3|Baseline|Total|Total of all reporting groups
898814|NCT01091519|B2|Baseline|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
898815|NCT01091519|B1|Baseline|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
898816|NCT01091519|P2|Participant Flow|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
898817|NCT01091519|P1|Participant Flow|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
898818|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
898819|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
899261|NCT01090063|O2|Outcome|Mean Pustule Count at Week 24|Average number of pustules present in all subjects at week 24
898820|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
898821|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
898822|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
898823|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
898824|NCT01091519|O2|Outcome|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
898825|NCT01091519|O1|Outcome|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
898826|NCT01091519|E2|Reported Event|Fesoterodine Without Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months.
898827|NCT01091519|E1|Reported Event|Fesoterodine With Educational Materials|Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months.
898828|NCT01091454|B1|Baseline|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898829|NCT01091454|P1|Participant Flow|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898830|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898831|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898832|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898833|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898834|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898835|NCT01091454|O1|Outcome|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898836|NCT01091454|E1|Reported Event|Treatment (Cisplatin and Brostallicin)|Patients receive 50 mg/m^2 cisplatin IV over 2 hours on day 1 and 10 mg/m^2 brostallicin IV over 10 minutes on day 2. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
898837|NCT01091259|B1|Baseline|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
898838|NCT01091259|P1|Participant Flow|Irinotecan With Bevacizumab|"Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.~Irinotecan~Bevacizumab"
898856|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
899262|NCT01090063|O1|Outcome|Mean Pustule Count at Baseline|Average number of pustules present in all subjects at baseline
898839|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
898840|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
898841|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
898842|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
898843|NCT01091259|O1|Outcome|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
898844|NCT01091259|E1|Reported Event|Irinotecan With Bevacizumab|Irinotecan is administered every 3 weeks at a dose of 175 mg/m^2, bevacizumab is administered at 15 mg/kg every 3 weeks. Irinotecan is administered before bevacizumab. Patients will continue on therapy until evidence of disease progression, or until development of adverse events that prevent further treatment, or if the patients wishes to discontinue therapy.
898845|NCT01091246|B4|Baseline|Total|Total of all reporting groups
898846|NCT01091246|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898847|NCT01091246|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
898848|NCT01091246|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898849|NCT01091246|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898850|NCT01091246|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
898851|NCT01091246|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898852|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898853|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898854|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898855|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
899263|NCT01090063|O1|Outcome|Median PGA|Median PGA at Week 24
911802|NCT01055704|O4|Outcome|Placebo|
898857|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898858|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898859|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898860|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898861|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898862|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898863|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898864|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898865|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898866|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898867|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898868|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898869|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898870|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898871|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898872|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898873|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
899001|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
899264|NCT01090063|O1|Outcome|Main|Percentage of patients achieving a palmar/plantar PGA score of 0 or 1 at week 16.
898874|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
898875|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898876|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898877|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898878|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898879|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898880|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898881|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898882|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
898883|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898884|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898885|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898886|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898887|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898888|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898889|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898890|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
898891|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898892|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898893|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898894|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898895|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898896|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
898897|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898898|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898899|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898900|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898901|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898902|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898903|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898904|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
899002|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
899265|NCT01090063|E1|Reported Event|Main|
898905|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898906|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898907|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898908|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898909|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898910|NCT01091246|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898911|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898912|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
898913|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898914|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898915|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898916|NCT01091246|O2|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898917|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898918|NCT01091246|O4|Outcome|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898919|NCT01091246|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza stains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
898920|NCT01091246|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent live attenuated influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
899003|NCT01091103|O2|Outcome|Enzalutamide, PSA Non-Responders at Week 9|PSA non-responders are defined by a less than 50% reduction from baseline in PSA at Week 9
899004|NCT01091103|O1|Outcome|Enzalutamide, PSA Responders at Week 9|PSA responders are defined by a greater than or equal to 50% reduction from baseline in PSA at Week 9
898921|NCT01091246|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898922|NCT01091246|E2|Reported Event|All FluMist Group|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined
898923|NCT01091246|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent live attenuated influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 resassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
898924|NCT01091155|B1|Baseline|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
898925|NCT01091155|P1|Participant Flow|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
898926|NCT01091155|O1|Outcome|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
898927|NCT01091155|E1|Reported Event|ColonRing TM|ColonRing (Colorectal anastomosis) : Creation of a colorectal compression anastomosis
898928|NCT01091116|B6|Baseline|Total|Total of all reporting groups
898929|NCT01091116|B5|Baseline|Placebo|two doses
898930|NCT01091116|B4|Baseline|Single High Dose|one dose+placebo
898931|NCT01091116|B3|Baseline|High Dose|two doses
898932|NCT01091116|B2|Baseline|Mid Dose|two doses
898933|NCT01091116|B1|Baseline|Low Dose|two doses
898934|NCT01091116|P5|Participant Flow|Placebo|two intra-articular placebo doses
898935|NCT01091116|P4|Participant Flow|Single High Dose|one intra-articular fasitibant dose 0.5 mg +placebo
898936|NCT01091116|P3|Participant Flow|High Dose|two intra-articular fasitibant doses; 0.5 mg each
898937|NCT01091116|P2|Participant Flow|Mid Dose|two intra-articular fasitibant doses; 0.25 mg each
898938|NCT01091116|P1|Participant Flow|Low Dose|two intra-articular fasitibant doses; 0.125 mg each
898939|NCT01091116|O5|Outcome|Placebo|two doses
898940|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898941|NCT01091116|O3|Outcome|High Dose|two doses
898942|NCT01091116|O2|Outcome|Mid Dose|two doses
898943|NCT01091116|O1|Outcome|Low Dose|two doses
898944|NCT01091116|O5|Outcome|Placebo|two doses
898945|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898946|NCT01091116|O3|Outcome|High Dose|two doses
898947|NCT01091116|O2|Outcome|Mid Dose|two doses
898948|NCT01091116|O1|Outcome|Low Dose|two doses
898949|NCT01091116|O5|Outcome|Placebo|two doses
898950|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898951|NCT01091116|O3|Outcome|High Dose|two doses
898952|NCT01091116|O2|Outcome|Mid Dose|two doses
898953|NCT01091116|O1|Outcome|Low Dose|two doses
898954|NCT01091116|O5|Outcome|Placebo|two doses
898955|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898956|NCT01091116|O3|Outcome|High Dose|two doses
898957|NCT01091116|O2|Outcome|Mid Dose|two doses
898958|NCT01091116|O1|Outcome|Low Dose|two doses
898959|NCT01091116|O5|Outcome|Placebo|two doses
898960|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898961|NCT01091116|O3|Outcome|High Dose|two doses
898962|NCT01091116|O2|Outcome|Mid Dose|two doses
898963|NCT01091116|O1|Outcome|Low Dose|two doses
898964|NCT01091116|O5|Outcome|Placebo|two doses
898965|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898966|NCT01091116|O3|Outcome|High Dose|two doses
898967|NCT01091116|O2|Outcome|Mid Dose|two doses
898968|NCT01091116|O1|Outcome|Low Dose|two doses
898969|NCT01091116|O5|Outcome|Placebo|two doses
898970|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898971|NCT01091116|O3|Outcome|High Dose|two doses
898972|NCT01091116|O2|Outcome|Mid Dose|two doses
898973|NCT01091116|O1|Outcome|Low Dose|two doses
898974|NCT01091116|O5|Outcome|Placebo|two doses
898975|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898976|NCT01091116|O3|Outcome|High Dose|two doses
898977|NCT01091116|O2|Outcome|Mid Dose|two doses
898978|NCT01091116|O1|Outcome|Low Dose|two doses
898979|NCT01091116|O5|Outcome|Placebo|two doses
898980|NCT01091116|O4|Outcome|Single High Dose|one dose+placebo
898981|NCT01091116|O3|Outcome|High Dose|two doses
898982|NCT01091116|O2|Outcome|Mid Dose|two doses
898983|NCT01091116|O1|Outcome|Low Dose|two doses
898984|NCT01091116|E5|Reported Event|Placebo|two doses
898985|NCT01091116|E4|Reported Event|Single High Dose|one dose+placebo
898986|NCT01091116|E3|Reported Event|High Dose|two doses
898987|NCT01091116|E2|Reported Event|Mid Dose|two doses
898988|NCT01091116|E1|Reported Event|Low Dose|two doses
898989|NCT01091103|B1|Baseline|Enzalutamide|
898990|NCT01091103|P1|Participant Flow|Enzalutamide|
898991|NCT01091103|O1|Outcome|Enzalutamide|
898992|NCT01091103|O1|Outcome|Enzalutamide|
898993|NCT01091103|O1|Outcome|Enzalutamide|
898994|NCT01091103|O1|Outcome|Enzalutamide|
898995|NCT01091103|O1|Outcome|Enzalutamide|
898996|NCT01091103|O1|Outcome|Enzalutamide|
898997|NCT01091103|O1|Outcome|Enzalutamide|
898998|NCT01091103|O1|Outcome|Enzalutamide|
898999|NCT01091103|O1|Outcome|Enzalutamide|
899000|NCT01091103|O1|Outcome|Enzalutamide|
899009|NCT01090973|B1|Baseline|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899010|NCT01090973|P1|Participant Flow|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899011|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899012|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899013|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899014|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899015|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899016|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899017|NCT01090973|O1|Outcome|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899018|NCT01090973|E1|Reported Event|Oral Drug Treatment|LBH589 was to be given orally (by mouth), 40 mg once-a-day, 3 times weekly every week on days 1, 3 & 5, then 8, 10 &12, then 15, 17 & 19, then 22, 24 & 26.
899019|NCT01090765|B7|Baseline|Total|Total of all reporting groups
899020|NCT01090765|B6|Baseline|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
899021|NCT01090765|B5|Baseline|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
899022|NCT01090765|B4|Baseline|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
899023|NCT01090765|B3|Baseline|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
899024|NCT01090765|B2|Baseline|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
899025|NCT01090765|B1|Baseline|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
899026|NCT01090765|P6|Participant Flow|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
899027|NCT01090765|P5|Participant Flow|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
899028|NCT01090765|P4|Participant Flow|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
899029|NCT01090765|P3|Participant Flow|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
899030|NCT01090765|P2|Participant Flow|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
899031|NCT01090765|P1|Participant Flow|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
899032|NCT01090765|O6|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
899033|NCT01090765|O5|Outcome|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
899034|NCT01090765|O4|Outcome|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
899035|NCT01090765|O3|Outcome|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
899036|NCT01090765|O2|Outcome|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
899037|NCT01090765|O1|Outcome|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
899038|NCT01090765|O1|Outcome|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
899039|NCT01090765|E6|Reported Event|TRC105 20 mg/kg Every 2 Weeks|Intravenous infusion at 20 mg/kg every 2 weeks
899040|NCT01090765|E5|Reported Event|TRC105 15 mg/kg Every 2 Weeks|Intravenous infusion at 15 mg/kg every 2 weeks
899041|NCT01090765|E4|Reported Event|TRC105 10 mg/kg Weekly|Intravenous infusion at 10 mg/kg weekly
899042|NCT01090765|E3|Reported Event|TRC105 10 mg/kg Every 2 Weeks|Intravenous infusion at 10 mg/kg every 2 weeks
899043|NCT01090765|E2|Reported Event|TRC105 3 mg/kg Every 2 Weeks|Intravenous infusion at 3 mg/kg every 2 weeks
899044|NCT01090765|E1|Reported Event|TRC105 1 mg/kg Every 2 Weeks|Intravenous infusion at 1 mg/kg every 2 weeks
899045|NCT01090752|B3|Baseline|Total|Total of all reporting groups
899046|NCT01090752|B2|Baseline|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
899047|NCT01090752|B1|Baseline|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
899048|NCT01090752|P2|Participant Flow|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
899049|NCT01090752|P1|Participant Flow|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
899050|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
899051|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
899052|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
899053|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
899054|NCT01090752|O2|Outcome|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
899055|NCT01090752|O1|Outcome|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
899266|NCT01090050|B3|Baseline|Total|Total of all reporting groups
899056|NCT01090752|E2|Reported Event|Placebo Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the placebo phase
899057|NCT01090752|E1|Reported Event|Pioglitazone Low Salt/High Salt|a low salt and a high salt diet were given consequently and randomly during a week at the end of the pioglitazone phase
899058|NCT01090739|B1|Baseline|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899059|NCT01090739|P1|Participant Flow|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899060|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
899061|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
899062|NCT01090739|O1|Outcome|TOPAS|"TOPAS Treatment for Fecal Incontinence~TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh."
899063|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899064|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899065|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899066|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899067|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899068|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899069|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899070|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899071|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899072|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899073|NCT01090739|O1|Outcome|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899074|NCT01090739|E1|Reported Event|TOPAS|TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
899075|NCT01090479|B3|Baseline|Total|Total of all reporting groups
899076|NCT01090479|B2|Baseline|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
899077|NCT01090479|B1|Baseline|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
899078|NCT01090479|P2|Participant Flow|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
899079|NCT01090479|P1|Participant Flow|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
899080|NCT01090479|O2|Outcome|Chlorhexidine|
899081|NCT01090479|O1|Outcome|Control|
899082|NCT01090479|E2|Reported Event|2% Chlorhexidine Cloth|This group will use the 2% chlorhexidine wipes the night prior as well as the morning of their surgery date.
899083|NCT01090479|E1|Reported Event|Control|This group will perform an ordinary shower the night prior and the morning of their scheduled surgery date.
899084|NCT01090453|B3|Baseline|Total|Total of all reporting groups
899221|NCT01090180|P1|Participant Flow|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
899085|NCT01090453|B2|Baseline|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899086|NCT01090453|B1|Baseline|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899087|NCT01090453|P2|Participant Flow|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899088|NCT01090453|P1|Participant Flow|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899089|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899090|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899091|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899092|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899093|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899094|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899095|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899096|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899097|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899147|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
911803|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
899098|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899099|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899100|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899101|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899102|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899103|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899104|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899105|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899106|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899107|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899108|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899109|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899110|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899124|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899173|NCT01090323|B3|Baseline|Total|Total of all reporting groups
899111|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899112|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899113|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899114|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899115|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899116|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899117|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899118|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899119|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899120|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899121|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899122|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899123|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899146|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899222|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
899125|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899126|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899127|NCT01090453|O2|Outcome|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899128|NCT01090453|O1|Outcome|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899129|NCT01090453|E2|Reported Event|Infanrix Hexa Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® and Menjugate® at 2, 4 and 12 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the right and upper left sides of the thigh, respectively and the Menjugate® vaccine was administered intramuscularly in the lower left thigh. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899130|NCT01090453|E1|Reported Event|GSK2202083A Group|Subjects aged between and including 8 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2202083A vaccine, co-administered with Prevenar 13® at 2, 4 and 12 months of age. The GSK2202083A and Prevenar 13® vaccines were administered intramuscularly into the right and left sides of the thigh, respectively. An optional 2-dose vaccination with Rotarix™ was offered to the study participants at 2 and 4 months of age.
899131|NCT01090427|B4|Baseline|Total|Total of all reporting groups
899132|NCT01090427|B3|Baseline|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899133|NCT01090427|B2|Baseline|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899134|NCT01090427|B1|Baseline|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899135|NCT01090427|P7|Participant Flow|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
899136|NCT01090427|P6|Participant Flow|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
899137|NCT01090427|P5|Participant Flow|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
899138|NCT01090427|P4|Participant Flow|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
899139|NCT01090427|P3|Participant Flow|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
899140|NCT01090427|P2|Participant Flow|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
899141|NCT01090427|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
899142|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899143|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899144|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899145|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
900647|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
899148|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899149|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899150|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899151|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899152|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899153|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899154|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899155|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899156|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899157|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899158|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899159|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899160|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899161|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899162|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899163|NCT01090427|O3|Outcome|Ustekinumab Standard Dosage|Participants received ustekinumab (0.75 mg/kg, 45 mg, or 90 mg based on body weight) subcutaneous (SC) injections at Weeks 0, 4, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899164|NCT01090427|O2|Outcome|Ustekinumab Half-Standard Dosage|Participants received ustekinumab subcutaneous (SC) injections (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) at Weeks 0, 16, 28, and 40. In addition, all participants received a single SC dose of placebo at Week 12.
899165|NCT01090427|O1|Outcome|Placebo|Participants received a subcutaneous (SC) injection of Placebo at Weeks 0 and 4 then crossover to ustekinumab half-standard dosage (0.375 mg/kg, 22.5 mg, or 45 mg based on body weight) OR ustekinumab standard dosage (0.75 mg/kg, 45 mg, or 90 mg based on body weight) SC injection at Weeks 12, 16, 28, and 40.
899166|NCT01090427|E7|Reported Event|Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage q12wk with last dose at Week 40.
899167|NCT01090427|E6|Reported Event|Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Ustekinumab Half-Standard Dosage at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage q12wk with the last dose at Week 40.
899168|NCT01090427|E5|Reported Event|Placebo -> Ustekinumab Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Standard Dosage at Week 12 and 16 then q12wk with last dose at Week 40.
899169|NCT01090427|E4|Reported Event|Placebo -> Ustekinumab Half-Standard Dosage (After CP)|After Controlled period (Week 12-60) – participants receiving Placebo at Weeks 0 and 4 -> receiving Ustekinumab Half-Standard Dosage at Week 12 and 16 then q12w with the last dose at Week 40.
899170|NCT01090427|E3|Reported Event|Ustekinumab Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.75 mg/kg for participants with weight <= 60kg, 45 mg for participants with weight > 60 to <= 100kg, and 90 mg for participants with weight > 100kg.
899171|NCT01090427|E2|Reported Event|Ustekinumab Half-Standard Dosage (CP)|Controlled period (Week 0-12) - Ustekinumab Subcutaneous (SC) injections of 0.375 mg/kg for participants with weight <= 60kg, 22.5 mg for participants with weight > 60 to <= 100kg, and 45 mg for participants with weight > 100kg.
899172|NCT01090427|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Subcutaneous (SC) injections at Week 0 and 4.
899174|NCT01090323|B2|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899175|NCT01090323|B1|Baseline|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899176|NCT01090323|P2|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899177|NCT01090323|P1|Participant Flow|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899178|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899179|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899180|NCT01090323|O2|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899181|NCT01090323|O1|Outcome|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899182|NCT01090323|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the Core Study 0109 (NCT00067080) and treated with ICL670 during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899183|NCT01090323|E1|Reported Event|ICL670|Participants treated with ICL670 during the Core Study 0109(NCT00067080) and during the extension phase. ICL670 was administered orally once a day based on the participant's body weight.
899184|NCT01090310|B5|Baseline|Total|Total of all reporting groups
899185|NCT01090310|B4|Baseline|Placebo|Placebo s.c. every 2 weeks
899186|NCT01090310|B3|Baseline|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899187|NCT01090310|B2|Baseline|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899188|NCT01090310|B1|Baseline|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
899189|NCT01090310|P4|Participant Flow|Placebo|Placebo s.c. every 2 weeks
899190|NCT01090310|P3|Participant Flow|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899191|NCT01090310|P2|Participant Flow|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899192|NCT01090310|P1|Participant Flow|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
899193|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
899194|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899195|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899196|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
899197|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
899198|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899199|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899200|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
899201|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
899202|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899203|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899204|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
899205|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
899206|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899207|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899208|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
899209|NCT01090310|O4|Outcome|Placebo|Placebo s.c. every 2 weeks
899210|NCT01090310|O3|Outcome|AIN457 150 mg Every 4 Weeks|AIN457 150 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899211|NCT01090310|O2|Outcome|AIN457 300 mg Every 4 Weeks|AIN457 300 mg s.c. monthly, alternating with placebo s.c. at Weeks 1 and 4 and then monthly
899212|NCT01090310|O1|Outcome|AIN457 300mg Every 2 Weeks|AIN457 300 mg s.c. every 2 weeks
899213|NCT01090310|E4|Reported Event|Placebo Every 2 Weeks|Placebo every 2 weeks
899214|NCT01090310|E3|Reported Event|AIN457 150mg Every 4 Weeks|AIN457 150mg every 4 weeks
899215|NCT01090310|E2|Reported Event|AIN457 300mg Every 4 Weeks|AIN457 300mg every 4 weeks
899216|NCT01090310|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300mg every 2 weeks
899217|NCT01090180|B3|Baseline|Total|Total of all reporting groups
899218|NCT01090180|B2|Baseline|Arm 2: Placebo|Placebo (sugar pill): inactive
899219|NCT01090180|B1|Baseline|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
899220|NCT01090180|P2|Participant Flow|Arm 2: Placebo|Placebo (sugar pill): inactive
899260|NCT01090063|O1|Outcome|Mean Baseline Fissure Count|Average number of fissures found on hands and feet at baseline
911804|NCT01055704|O2|Outcome|Codeine 30 mg|
899223|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
899224|NCT01090180|O2|Outcome|Arm 2: Placebo|Placebo (sugar pill): inactive
899225|NCT01090180|O1|Outcome|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
899226|NCT01090180|E2|Reported Event|Arm 2: Placebo|Placebo (sugar pill): inactive
899227|NCT01090180|E1|Reported Event|Arm 1: Dexamethasone|Dexamethasone: anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
899228|NCT01090102|B3|Baseline|Total|Total of all reporting groups
899229|NCT01090102|B2|Baseline|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899230|NCT01090102|B1|Baseline|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899231|NCT01090102|P2|Participant Flow|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899232|NCT01090102|P1|Participant Flow|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899233|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899234|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899235|NCT01090102|O2|Outcome|Placebo Then Mesalamine|Placebo: Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth), followed by Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899236|NCT01090102|O1|Outcome|Mesalamine Then Placebo|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth), followed by Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth).
899237|NCT01090102|E2|Reported Event|Placebo|Placebo: Four placebo capsules once daily (1.5g/d) PO (by mouth).
899238|NCT01090102|E1|Reported Event|Mesalamine|Mesalamine (5-aminosalicylic acid, Apriso): Four mesalamine capsules once daily (1.5 gram/day) PO(by mouth).
899239|NCT01090076|B3|Baseline|Total|Total of all reporting groups
899240|NCT01090076|B2|Baseline|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899241|NCT01090076|B1|Baseline|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899242|NCT01090076|P2|Participant Flow|Placebo|Placebo x 2 sachets/d
899243|NCT01090076|P1|Participant Flow|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
899244|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899245|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899246|NCT01090076|O2|Outcome|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899247|NCT01090076|O1|Outcome|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899248|NCT01090076|O2|Outcome|Placebo|Placebo x 2 sachets/d
899249|NCT01090076|O1|Outcome|Abound|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal)
899250|NCT01090076|E2|Reported Event|Placebo|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899251|NCT01090076|E1|Reported Event|Abound|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB) : Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
899252|NCT01090063|B1|Baseline|Main|
899253|NCT01090063|P1|Participant Flow|Main|All participants were treated the same
899254|NCT01090063|O1|Outcome|Number of Participants With AEs|
899255|NCT01090063|O2|Outcome|Mean Week 24 Pain VAS Score|Average score of the pain VAS at Week 24. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
899256|NCT01090063|O1|Outcome|Mean Baseline Pain VAS Score|Average score of the pain VAS at baseline. 100 indicates maximum pain (worse outcome), 0 indicates minimum pain (better outcome).
899257|NCT01090063|O2|Outcome|Mean Week 24 Pruritus VAS Score|Average pruritus VAS score as measured at week 24. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
899258|NCT01090063|O1|Outcome|Mean Baseline Pruritus VAS Score|Average pruritus VAS score as measured at baseline. Maximum score is 100, minimum score is 0. 100 indicates maximum itch (worse outcome), 0 indicates minimum itch (better outcome).
899259|NCT01090063|O2|Outcome|Mean Week 24 Fissure Count|Average number of fissures found on hands and feet at Week 24
899267|NCT01090050|B2|Baseline|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to naproxen will treat daily with 1 tablet naproxen 500mg per day x 30 days. Subjects will be provided with 30 tablets of naproxen 500mg for rescue. In Treatment Period Months 2 and 3: Subjects randomized to naproxen will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of naproxen 500mg per month for rescue.
899268|NCT01090050|B1|Baseline|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Treximet will treat daily with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Treximet for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Treximet will be provided with 14 tablets of Treximet to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Treximet per month for rescue.
899269|NCT01090050|P2|Participant Flow|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899270|NCT01090050|P1|Participant Flow|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899271|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899272|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899273|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500 mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899274|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85 mg / naproxen sodium 500 mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899275|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899276|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899277|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899278|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899279|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899295|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
911805|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
899280|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899281|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899282|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899283|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899284|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899285|NCT01090050|O2|Outcome|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium 500mg per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899286|NCT01090050|O1|Outcome|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen will treat daily with 1 tablet Sumatriptan/Naproxen per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen will be provided with 14 tablets of Sumatriptan/Naproxen to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen per month for rescue.
899287|NCT01090050|E2|Reported Event|Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Naproxen Sodium will treat daily with 1 tablet Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Naproxen Sodium will be provided with 14 tablets of naproxen 500mg to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Naproxen Sodium per month for rescue.
899288|NCT01090050|E1|Reported Event|Sumatriptan/Naproxen Sodium|In Treatment Period Month 1: Subjects randomized to Sumatriptan/Naproxen Sodium will treat daily with 1 tablet Sumatriptan/Naproxen Sodium per day x 30 days. Subjects will be provided with 30 tablets of Sumatriptan/Naproxen Sodium for rescue. In Treatment Period Months 2 and 3: Subjects randomized to Sumatriptan/Naproxen Sodium will be provided with 14 tablets of Sumatriptan/Naproxen Sodium to treat on 14 or fewer days per month. Subjects will be provided with 14 tablets of Sumatriptan/Naproxen Sodium per month for rescue.
899289|NCT01090011|B1|Baseline|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
899290|NCT01090011|P1|Participant Flow|Total Patients|"All patients entered and treated. The objective of this study was to determine the maximum tolerated dose of Afatinib using a 3+3 Up-and-Down trial design. Cohorts of three to six participants were entered (not randomized) sequentially into escalating dosage tiers of afatinib/cetuximab. The dose of cetuximab in successive cohorts was increased unless two or more of the six participants (of the current cohort) had dose limiting toxicity events."
899291|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899292|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899293|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899294|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899320|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899296|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899297|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899298|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899299|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899300|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899301|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899302|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899303|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899304|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899305|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899306|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899307|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899308|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899309|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899310|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899311|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899312|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899313|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899314|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899315|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899316|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899317|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899318|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899319|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899457|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899321|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899322|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899323|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899324|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899325|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899326|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899327|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899328|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899329|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899330|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899331|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899332|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899333|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899334|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899335|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899336|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899337|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899338|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899339|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899340|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899341|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899342|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899343|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899568|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
899344|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899345|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899346|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899347|NCT01090011|O4|Outcome|Sequential Arm - Combination Therapy (Afa40+Ctx500)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899348|NCT01090011|O3|Outcome|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|"Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the Maximum Tolerated Dose (MTD) determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib)~Afatinib 40 mg (Afa40 Mono)"
899349|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899350|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899351|NCT01090011|O2|Outcome|Combination Arm - Afa40+Ctx500|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)"
899352|NCT01090011|O1|Outcome|Combination Arm - Afa40+Ctx250|"Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with Acquired Resistance (AR) to erlotinib or gefitinib)~Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)"
899353|NCT01090011|E4|Reported Event|Sequential Arm - Combination Therapy (Afa40+Ctx500)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
899354|NCT01090011|E3|Reported Event|Sequential Arm - Afatanib Monotherapy (Afa40 Mono)|Sequential Arm (includes patients who received afatinib monotherapy and upon progression the combination of afatinib and cetuximab at the MTD determined in the combination arm. Patients still needed to have met the criteria for AR to erlotinib or gefitinib) Afatinib 40 mg (Afa40 Mono)
899355|NCT01090011|E2|Reported Event|Combination Arm - Afa40+Ctx500|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 500 mg/m2 (Afa40+Ctx500)
899356|NCT01090011|E1|Reported Event|Combination Arm - Afa40+Ctx250|Combination Arm (includes the initial dose escalation and expansion cohort of upfront afatinib plus cetuximab in patients with AR to erlotinib or gefitinib) Afatinib 40 mg + cetuximab 250 mg/m2 (Afa40+Ctx250)
899357|NCT01089751|B3|Baseline|Total|Total of all reporting groups
899358|NCT01089751|B2|Baseline|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899359|NCT01089751|B1|Baseline|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899360|NCT01089751|P2|Participant Flow|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899361|NCT01089751|P1|Participant Flow|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899362|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899363|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899364|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899365|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899366|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899367|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899368|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899369|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899370|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899371|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899372|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899373|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899374|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899375|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899376|NCT01089751|O2|Outcome|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899377|NCT01089751|O1|Outcome|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899378|NCT01089751|E2|Reported Event|Placebo|Placebo once daily on an empty stomach for 14 weeks.
899379|NCT01089751|E1|Reported Event|Sanctura XR®|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks.
899380|NCT01089608|B3|Baseline|Total|Total of all reporting groups
899381|NCT01089608|B2|Baseline|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899382|NCT01089608|B1|Baseline|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899383|NCT01089608|P2|Participant Flow|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899384|NCT01089608|P1|Participant Flow|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899385|NCT01089608|O2|Outcome|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899386|NCT01089608|O1|Outcome|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899387|NCT01089608|E2|Reported Event|Azithromycin|"Eye drops Single dose unit~Azithromycin: Eye drops, Dosage : 1.5%~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899388|NCT01089608|E1|Reported Event|Unifluid|"Eye drops in Single Dose Unit~Povidone: Eye drops Single dose unit~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
899389|NCT01089595|B3|Baseline|Total|Total of all reporting groups
899390|NCT01089595|B2|Baseline|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
899391|NCT01089595|B1|Baseline|Nilotinib|Nilotinib 400 mg po bid
899392|NCT01089595|P2|Participant Flow|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
899393|NCT01089595|P1|Participant Flow|Nilotinib|Nilotinib 400 mg po bid
899394|NCT01089595|O2|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
899395|NCT01089595|O1|Outcome|Nilotinib|Nilotinib 400 mg po bid
899396|NCT01089595|O2|Outcome|Nilotinib + Imatinib|Nilotinib 400 mg twice daily (BID) with Imatinib 400 mg daily
899397|NCT01089595|O1|Outcome|Nilotinib|Nilotinib 400 mg by mouth (PO), twice daily (BID)
899398|NCT01089595|E2|Reported Event|Nilotinib + Imatinib|Nilotinib 400 mg BID with Imatinib 400 mg daily
899399|NCT01089595|E1|Reported Event|Nilotinib|Nilotinib 400 mg po bid
899400|NCT01089582|B1|Baseline|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899401|NCT01089582|P1|Participant Flow|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899402|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899403|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899404|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899405|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899406|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899407|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899408|NCT01089582|O1|Outcome|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899409|NCT01089582|E1|Reported Event|ARICEPT|ARICEPT (donepezil hydrochloride) 5 milligram (mg) or 10 mg once daily (QD) orally. 5 mg QD was maintained for at least 4 weeks. The recommended maximum dose was 10 mg QD.
899410|NCT01089569|B4|Baseline|Total|Total of all reporting groups
899411|NCT01089569|B3|Baseline|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899412|NCT01089569|B2|Baseline|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results~Insulin Glargine: refer to Arm detail"
899413|NCT01089569|B1|Baseline|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study~Exenatide: refer to Arm detail"
899414|NCT01089569|P3|Participant Flow|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899415|NCT01089569|P2|Participant Flow|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899416|NCT01089569|P1|Participant Flow|Exenatide|5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
899417|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899418|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899419|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
911806|NCT01055704|O4|Outcome|Placebo|
899420|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899421|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899422|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
899423|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899424|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899425|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
899426|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899427|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899428|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
899429|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899430|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899431|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
899432|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899433|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899434|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
899435|NCT01089569|O3|Outcome|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899436|NCT01089569|O2|Outcome|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
899437|NCT01089569|O1|Outcome|Exenatide|5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study
899438|NCT01089569|E3|Reported Event|Exenatide + Insulin Glargine|"Exenatide: 5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study~+ Insulin Glargine: 0.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results"
899439|NCT01089569|E2|Reported Event|Insulin Glargine|".1 unit per kg to start, titrated based on Continuous Glucose Monitoring results~Insulin Glargine: refer to Arm detail"
899440|NCT01089569|E1|Reported Event|Exenatide|"5 mcg BID for 1 month increasing to 10 mcg BID for the remainder of the study~Exenatide: refer to Arm detail"
899441|NCT01089556|B3|Baseline|Total|Total of all reporting groups
899442|NCT01089556|B2|Baseline|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899443|NCT01089556|B1|Baseline|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899444|NCT01089556|P6|Participant Flow|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
899445|NCT01089556|P5|Participant Flow|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
899446|NCT01089556|P4|Participant Flow|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
899447|NCT01089556|P3|Participant Flow|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
899448|NCT01089556|P2|Participant Flow|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899449|NCT01089556|P1|Participant Flow|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
899450|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899451|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899452|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899453|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899454|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899455|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899456|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
900648|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
899458|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899459|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899460|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899461|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899462|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899463|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899464|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899465|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899466|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899467|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899468|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899469|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899470|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899471|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899472|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899473|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899474|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899475|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899476|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899477|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899478|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899479|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899480|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899481|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899482|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899483|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899484|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899485|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
900649|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
899486|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899487|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899488|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899489|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899490|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899491|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899492|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899493|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899494|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899495|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899496|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899497|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899498|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899499|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899500|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899501|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899502|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899503|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899504|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899505|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899506|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899507|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899508|NCT01089556|O2|Outcome|Pregabalin|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899509|NCT01089556|O1|Outcome|Duloxetine|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II.
899510|NCT01089556|O2|Outcome|Monotherapy|All participants who received Duloxetine Monotherapy (Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16) or Pregabalin Monotherapy (Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16) in Study Period III were pooled together.
899511|NCT01089556|O1|Outcome|Combination|All participants who received Duloxetine Combination therapy (Duloxetine 60 milligram [mg] plus Pregabalin 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16) or Pregabalin Combination therapy (Pregabalin 300 mg plus Duloxetine 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16) in Study Period III were pooled together.
899512|NCT01089556|E6|Reported Event|Pregabalin (SP III)|Pregabalin 450 mg daily for Week 9 and Pregabalin 600 mg daily for Weeks 10-16 in Study Period III.
899513|NCT01089556|E5|Reported Event|PGB + DLX (SP III)|Pregabalin (PGB) 300 mg plus Duloxetine (DLX) 30 mg daily for Week 9 and Pregabalin 300 mg plus Duloxetine 60 mg daily for Weeks 10-16 in Study Period III.
899514|NCT01089556|E4|Reported Event|DLX + PGB (SP III)|Duloxetine (DLX) 60 mg plus Pregabalin (PGB) 150 mg daily for Week 9 and Duloxetine 60 mg plus Pregabalin 300 mg daily for Weeks 10-16 in Study Period III.
899515|NCT01089556|E3|Reported Event|Duloxetine (SP III)|Duloxetine 90 mg daily for Week 9 and 120 mg daily for Weeks 10-16 in Study Period III (SP III).
899516|NCT01089556|E2|Reported Event|Pregabalin (SP II)|Pregabalin 150 mg daily for Week 1 and 300 mg daily for Weeks 2-8 in Study Period II.
899517|NCT01089556|E1|Reported Event|Duloxetine (SP II)|Duloxetine 30 milligram (mg) daily for Week 1 and 60 mg daily for Weeks 2-8 in Study Period II (SP II).
899518|NCT01089543|B5|Baseline|Total|Total of all reporting groups
899519|NCT01089543|B4|Baseline|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
899520|NCT01089543|B3|Baseline|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
899521|NCT01089543|B2|Baseline|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
899522|NCT01089543|B1|Baseline|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
899523|NCT01089543|P4|Participant Flow|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
899524|NCT01089543|P3|Participant Flow|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
899525|NCT01089543|P2|Participant Flow|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
899526|NCT01089543|P1|Participant Flow|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
899527|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
899528|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
899529|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
899530|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
899531|NCT01089543|O4|Outcome|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
899532|NCT01089543|O3|Outcome|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
899533|NCT01089543|O2|Outcome|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
899534|NCT01089543|O1|Outcome|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
899535|NCT01089543|E4|Reported Event|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
899536|NCT01089543|E3|Reported Event|Rabeprazole 40 mg|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
899537|NCT01089543|E2|Reported Event|Rabeprazole 20 mg|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
899538|NCT01089543|E1|Reported Event|Rabeprazole 10 mg|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
899539|NCT01089517|B4|Baseline|Total|Total of all reporting groups
899540|NCT01089517|B3|Baseline|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
899541|NCT01089517|B2|Baseline|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
899542|NCT01089517|B1|Baseline|Lucentis|Sham/Lucentis 0.5 mg
899543|NCT01089517|P3|Participant Flow|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
899544|NCT01089517|P2|Participant Flow|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
899545|NCT01089517|P1|Participant Flow|Lucentis|Sham/Lucentis 0.5 mg
899546|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
899547|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
899548|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
899549|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
899550|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
899551|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
899552|NCT01089517|O3|Outcome|E10030 1.5 mg/Lucentis 0.5 mg|E10030 1.5 mg/Lucentis 0.5 mg
899553|NCT01089517|O2|Outcome|E10030 0.3 mg/Lucentis 0.5 mg|E10030 0.3 mg/Lucentis 0.5 mg
899554|NCT01089517|O1|Outcome|Lucentis|Sham/Lucentis 0.5 mg
899555|NCT01089517|E3|Reported Event|E10030 High Dose Plus Lucentis|E10030 1.5 mg/Lucentis 0.5 mg
899556|NCT01089517|E2|Reported Event|E10030 Low Dose Plus Lucentis|E10030 0.3 mg/Lucentis 0.5 mg
899557|NCT01089517|E1|Reported Event|Lucentis|Sham/Lucentis 0.5 mg
899558|NCT01089504|B3|Baseline|Total|Total of all reporting groups
899559|NCT01089504|B2|Baseline|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
899560|NCT01089504|B1|Baseline|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
899561|NCT01089504|P2|Participant Flow|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
899562|NCT01089504|P1|Participant Flow|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
899563|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
899564|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
899565|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
899566|NCT01089504|O1|Outcome|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
899567|NCT01089504|O2|Outcome|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
899673|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
899569|NCT01089504|E2|Reported Event|Placebo|"Placebo in a volume equivalent to active drug for 4 months~placebo: Matched placebo, same volume as active drug, by mouth daily for 4 months"
899570|NCT01089504|E1|Reported Event|Phenobarbital|"Phenobarbital, 4-5 mg/kg/day, for 4 months~phenobarbital: Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months"
899571|NCT01089413|B4|Baseline|Total|Total of all reporting groups
899572|NCT01089413|B3|Baseline|Bevacizumab: Age >80 Years|Participants aged greater than (>) 80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899573|NCT01089413|B2|Baseline|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899574|NCT01089413|B1|Baseline|Bevacizumab: Age <70 Years|Participants aged less than (<) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899575|NCT01089413|P1|Participant Flow|Bevacizumab: Overall|All participants with Metastatic Colorectal Cancer (mCRC) for whom the physician decided to prescribe bevacizumab (Avastin) as part of their first line treatment and in line with current Summary of Product Characteristics (SmPC) (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899576|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899577|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899578|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899579|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899580|NCT01089413|O4|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899581|NCT01089413|O3|Outcome|Bevacizumab: Age >80 Years|Participants aged >80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899582|NCT01089413|O2|Outcome|Bevacizumab: Age 70-80 Years|Participants aged between 70-80 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899583|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged <70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899584|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899585|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
899586|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899668|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose 2 hours from time of first dose.
899587|NCT01089413|O3|Outcome|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899588|NCT01089413|O2|Outcome|Bevacizumab: Age ≥70 Years|Participants aged greater than or equal to (≥) 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed. Due to the small number of participants aged >80 years, the age groups “70-80 Years” and “>80 Years” have been pooled in this group.
899589|NCT01089413|O1|Outcome|Bevacizumab: Age <70 Years|Participants aged < 70 years, with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899590|NCT01089413|E1|Reported Event|Bevacizumab: Overall|All participants with mCRC for whom the physician decided to prescribe bevacizumab as part of their first line treatment and in line with current SmPC (or local label). The decision to prescribe bevacizumab was independent of the study and was the responsibility of the treating physician. All concomitant medications as used in daily routine clinical practice were allowed.
899591|NCT01089231|B5|Baseline|Total|Total of all reporting groups
899592|NCT01089231|B4|Baseline|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
899593|NCT01089231|B3|Baseline|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
899594|NCT01089231|B2|Baseline|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
899595|NCT01089231|B1|Baseline|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
899596|NCT01089231|P4|Participant Flow|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
899597|NCT01089231|P3|Participant Flow|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
899598|NCT01089231|P2|Participant Flow|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
899599|NCT01089231|P1|Participant Flow|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
899600|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
899601|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
899602|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
899603|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
899604|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
899605|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
899606|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
899607|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
899608|NCT01089231|O4|Outcome|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
899609|NCT01089231|O3|Outcome|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
899610|NCT01089231|O2|Outcome|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
899611|NCT01089231|O1|Outcome|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
899612|NCT01089231|E4|Reported Event|Fish Oil - Healthy Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months. n=9
899613|NCT01089231|E3|Reported Event|Fish Oil - Hyperlipidemic Subjects|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months n=8
899614|NCT01089231|E2|Reported Event|Placebo - Hyperlipedemic Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=8
899615|NCT01089231|E1|Reported Event|Placebo - Healthy Subjects|Dietary Supplement: corn oil capsules (6 per day) about 3 months n=6
899616|NCT01089127|B7|Baseline|Total|Total of all reporting groups
899617|NCT01089127|B6|Baseline|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899618|NCT01089127|B5|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899619|NCT01089127|B4|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899620|NCT01089127|B3|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899621|NCT01089127|B2|Baseline|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899622|NCT01089127|B1|Baseline|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899623|NCT01089127|P6|Participant Flow|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899624|NCT01089127|P5|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899625|NCT01089127|P4|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899626|NCT01089127|P3|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899627|NCT01089127|P2|Participant Flow|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899628|NCT01089127|P1|Participant Flow|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer’s proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899629|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899630|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899631|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899669|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
899670|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
899632|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899633|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899634|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899635|NCT01089127|O6|Outcome|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899636|NCT01089127|O5|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899637|NCT01089127|O4|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899638|NCT01089127|O3|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899639|NCT01089127|O2|Outcome|Indacaterol 37.5 μg|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899640|NCT01089127|O1|Outcome|Indacaterol 18.75 μg|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899641|NCT01089127|E6|Reported Event|Placebo|Patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899642|NCT01089127|E5|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. In addition, patients inhaled placebo to indacaterol once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899643|NCT01089127|E4|Reported Event|Indacaterol 150 ug|Patients inhaled indacaterol 150 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899644|NCT01089127|E3|Reported Event|Indacaterol 75 ug|Patients inhaled indacaterol 75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899671|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
899672|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
899645|NCT01089127|E2|Reported Event|Indacaterol 37.5 ug|Patients inhaled indacaterol 37.5 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899646|NCT01089127|E1|Reported Event|Indacaterol 18.75 ug|Patients inhaled indacaterol 18.75 μg once daily in the morning via the Concept1 single-dose dry-powder inhaler (SDDPI). In addition, patients inhaled placebo to salmeterol twice daily, once in the morning and once in the evening, via the manufacturer's proprietary Diskus inhaler. Treatment continued for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. Albuterol via a multi-dose dry-powder inhaler (MDI) was available for rescue use throughout the study.
899647|NCT01089062|B7|Baseline|Total|Total of all reporting groups
899648|NCT01089062|B6|Baseline|Treatment C, Then B, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
899649|NCT01089062|B5|Baseline|Treatment C, Then A, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
899650|NCT01089062|B4|Baseline|Treatment B, Then C, Then A|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
899651|NCT01089062|B3|Baseline|Treatment B, Then A, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
899652|NCT01089062|B2|Baseline|Treatment A, Then C, Then B|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
899653|NCT01089062|B1|Baseline|Treatment A, Then B, Then C|"Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose."
899654|NCT01089062|P6|Participant Flow|Treatment C, Then B, Then A|"The second dose in each treatment group (C,B,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
899655|NCT01089062|P5|Participant Flow|Treatment C, Then A, Then B|"The second dose in each treatment group (C,A,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
899656|NCT01089062|P4|Participant Flow|Treatment B, Then C, Then A|"The second dose in each treatment group (B,C,A) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 4."
899657|NCT01089062|P3|Participant Flow|Treatment B, Then A, Then C|"The second dose in each treatment group (B,A,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 2.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
899658|NCT01089062|P2|Participant Flow|Treatment A, Then C, Then B|"The second dose in each treatment group (A,C,B) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose at Visit 2.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 3.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 4."
899659|NCT01089062|P1|Participant Flow|Treatment A, Then B, Then C|"The second dose in each treatment group (A,B,C) was given two hours from the time of the first dose. There were 7-11 days between each treatment visit.~Treatment A = inhaler placebo and Intravenous (IV) Dihydroergotamine (DHE) for first dose, inhaler placebo for second dose at Visit 2.~Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose at Visit 3.~Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose at Visit 4."
899660|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
899661|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
899662|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
899663|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
899664|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
899665|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
899666|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
899667|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
899675|NCT01089062|O3|Outcome|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
899676|NCT01089062|O2|Outcome|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
899677|NCT01089062|O1|Outcome|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
899678|NCT01089062|E3|Reported Event|Treatment C|Treatment C = inhaler placebo and IV placebo for first dose, inhaler placebo for second dose.
899679|NCT01089062|E2|Reported Event|Treatment B|Treatment B = MAP0004 1.0mg and IV placebo for first dose, MAP0004 1.0mg for second dose.
899680|NCT01089062|E1|Reported Event|Treatment A|Treatment A = inhaler placebo and IV DHE for first dose, inhaler placebo for second dose.
899681|NCT01089023|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899682|NCT01089023|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenous (IV) infusion, once every 4 weeks for a total of 6 infusions.
899683|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899684|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899685|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899686|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899687|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899688|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899689|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899690|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899691|NCT01089023|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV infusion, once every 4 weeks for a total of 6 infusions.
899692|NCT01089023|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions.
899693|NCT01088997|B3|Baseline|Total|Total of all reporting groups
899694|NCT01088997|B2|Baseline|Low Dose Milrinone|Subjects received a 20mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2mcg/kg over 24 hours
899695|NCT01088997|B1|Baseline|High Dose Milrinone|Subjects received a 50mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5mcg/kg over 24 hours
899696|NCT01088997|P2|Participant Flow|Low Dose Milrinone|Subjects received a 20 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.2 mcg/kg/min over 24 hours.
899697|NCT01088997|P1|Participant Flow|High Dose Milrinone|Subjects received a 50 mcg/kg loading dose of milrinone lactate given intravenously (IV) over 1 hour followed by an IV infusion of 0.5 mcg/kg/min over 24 hours.
899698|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into the study, of these 2 completed study treatment and only 1 received 2 MPI measurements
899699|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into the study, of these 4 completed study treatment.
899700|NCT01088997|O1|Outcome|Milrinone Population|Population model developed based on 6 subjects who completed study treatment and were deemed evaluable.
899701|NCT01088997|O2|Outcome|Low Dose Milrinone|5 subjects were enrolled into this arm, of these only 2 completed study treatment.
899702|NCT01088997|O1|Outcome|High Dose Milrinone|7 subjects were enrolled into this arm, of these only 4 completed study treatment.
899703|NCT01088997|E2|Reported Event|Low Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 20 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.2 mcg/kg/min milrinone lactate over 24 hours.
899704|NCT01088997|E1|Reported Event|High Dose Milrinone|Subjects received a bolus intravenous (IV) infusion of 50 mcg/kg/min of milrinone lactate over 1 hour followed by a continuous IV infusion of 0.5 mcg/kg/min milrinone lactate over 24 hours.
899705|NCT01088984|B3|Baseline|Total|Total of all reporting groups
899706|NCT01088984|B2|Baseline|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899707|NCT01088984|B1|Baseline|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899708|NCT01088984|P2|Participant Flow|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899709|NCT01088984|P1|Participant Flow|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899710|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899711|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899750|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
900650|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
899751|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
899712|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899713|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899714|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899715|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899716|NCT01088984|O2|Outcome|Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899717|NCT01088984|O1|Outcome|Bendamustine 90 mg/m^2|Bendamustine 90 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of a 21-day Induction cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899718|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899719|NCT01088984|O3|Outcome|Total|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899720|NCT01088984|O2|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899721|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899722|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899723|NCT01088984|O1|Outcome|Phase 2: Bendamustine 120 mg/m^2|Bendamustine 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (Cycles 2 through 12), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899724|NCT01088984|O1|Outcome|Phase 1: Bendamustine 90 or 120 mg/m^2|Bendamustine 90 or 120 mg/m^2 administered as an IV infusion over 60 minutes on Days 1 and 2 of a 21-day Induction Cycle, with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899725|NCT01088984|E1|Reported Event|Bendamustine|Bendamustine 90 or 120 mg/m^2 administered as an intravenous (IV) infusion over 60 minutes on Days 1 and 2 of each 21-day cycle (maximum of 12 total cycles), with delays up to 2 weeks for neutrophil and platelet count recovery, for up to a 35-day cycle.
899726|NCT01088711|B5|Baseline|Total|Total of all reporting groups
899727|NCT01088711|B4|Baseline|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
899728|NCT01088711|B3|Baseline|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
899729|NCT01088711|B2|Baseline|T2D Participants (Panel B)|Obese participants with T2D received once-weekly omarigliptin or placebo for 4 weeks.
899730|NCT01088711|B1|Baseline|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
899731|NCT01088711|P4|Participant Flow|T2D - Placebo|Obese T2D participants received once-weekly placebo for 4 weeks.
899732|NCT01088711|P3|Participant Flow|T2D - Omarigliptin|Obese T2D participants received once-weekly omarigliptin for 4 weeks.
899733|NCT01088711|P2|Participant Flow|Healthy - Placebo|Obese healthy participants received once-weekly placebo for 4 weeks.
899734|NCT01088711|P1|Participant Flow|Healthy Participants - Omarigliptin|Obese healthy participants received once-weekly omarigliptin for 4 weeks.
899735|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
899736|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
899737|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
899738|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
899739|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
899740|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
899741|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
899742|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
899743|NCT01088711|O2|Outcome|Placebo|Obese healthy and T2D participants received once-weekly placebo for 4 weeks.
899744|NCT01088711|O1|Outcome|Omarigliptin 50 mg|Obese healthy and T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
899745|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
899746|NCT01088711|O3|Outcome|T2D Omarigliptin|Obese participants with T2D received once-weekly omarigliptin 50 mg for 4 weeks (Panel B).
899747|NCT01088711|O2|Outcome|Healthy Placebo|Obese healthy participants received once-weekly placebo for 4 weeks (Panel A).
899748|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
899749|NCT01088711|O4|Outcome|T2D Placebo|Obese participants with T2D received once-weekly placebo for 4 weeks (Panel B).
899752|NCT01088711|O1|Outcome|Healthy Omarigliptin|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks (Panel A).
899753|NCT01088711|E4|Reported Event|Placebo T2D (Panel B)|Obese T2D participants received once-weekly placebo for 4 weeks.
899754|NCT01088711|E3|Reported Event|Omarigliptin 50 mg T2D (Panel B)|Obese T2D participants received once-weekly omarigliptin 50 mg for 4 weeks.
899755|NCT01088711|E2|Reported Event|Placebo Healthy (Panel A)|Obese healthy participants received once-weekly placebo for 4 weeks.
899756|NCT01088711|E1|Reported Event|Omarigliptin 50 mg Healthy (Panel A)|Obese healthy participants received once-weekly omarigliptin 50 mg for 4 weeks.
899757|NCT01088672|B1|Baseline|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
899758|NCT01088672|P1|Participant Flow|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
899759|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
899760|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
899761|NCT01088672|O1|Outcome|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
899762|NCT01088672|E1|Reported Event|Acute Ischemic Stroke|"Single arm post market surveillance study for CE marked mechanical thrombectomy device, Trevo retriever for treatment of eligible patients experiencing acute ischemic stroke Mechanical thrombectomy intervention for all subjects in Acute Ischemic Stroke~Mechanical Thrombectomy: The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke."
899763|NCT01088646|B1|Baseline|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
899764|NCT01088646|P1|Participant Flow|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
899765|NCT01088646|O1|Outcome|Pillcam Express Capsule Delivery System|The delivery system is comprised of three parts: a catheter, a syringe and a capsule holder.
899766|NCT01088646|E1|Reported Event|PillCam Express Capsule Delivery System|PillCam® Express Capsule Endoscopy Delivery System was used in conjunction with the endoscope to introduce a PillCam® SB capsule into the proximal duodenum. After the capsule was released in the designated location, a standard of care upper GI endoscopy was performed.
899767|NCT01088529|B3|Baseline|Total|Total of all reporting groups
899768|NCT01088529|B2|Baseline|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
899769|NCT01088529|B1|Baseline|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
899770|NCT01088529|P2|Participant Flow|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
899771|NCT01088529|P1|Participant Flow|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
899772|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
899773|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
899774|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
899775|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
899776|NCT01088529|O2|Outcome|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
900651|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
900285|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
899777|NCT01088529|O1|Outcome|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
899778|NCT01088529|E2|Reported Event|LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) prior to radical prostatectomy.
899779|NCT01088529|E1|Reported Event|AA+LHRHa|Participants received luteinizing hormone-releasing hormone analog (LHRHa) for a maximum of 4 months (monthly injection or injection every 3 months) and 1,000 mg abiraterone acetate (AA) plus 5 mg of prednisone daily for 3 months prior to radical prostatectomy
899780|NCT01088503|B4|Baseline|Total|Total of all reporting groups
899781|NCT01088503|B3|Baseline|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
899782|NCT01088503|B2|Baseline|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899783|NCT01088503|B1|Baseline|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899784|NCT01088503|P3|Participant Flow|Ticlopidine/Ticagrelor|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
899785|NCT01088503|P2|Participant Flow|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899786|NCT01088503|P1|Participant Flow|Prasugrel|Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899787|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
899788|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899789|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
899790|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899791|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899792|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899793|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899794|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899795|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899796|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899797|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899798|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899799|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899800|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899801|NCT01088503|O2|Outcome|Other|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel, or ticlopidine, or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician
899802|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899803|NCT01088503|O2|Outcome|Clopidogrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899804|NCT01088503|O1|Outcome|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899805|NCT01088503|E1|Reported Event|Prasugrel|Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
899806|NCT01088464|B4|Baseline|Total|Total of all reporting groups
900279|NCT01086969|E1|Reported Event|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
899807|NCT01088464|B3|Baseline|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899808|NCT01088464|B2|Baseline|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899809|NCT01088464|B1|Baseline|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899810|NCT01088464|P3|Participant Flow|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899811|NCT01088464|P2|Participant Flow|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899812|NCT01088464|P1|Participant Flow|Cohort 1: Necitumumab|Necitumumab 600 milligrams (mg) administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899813|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899814|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899815|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899816|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899817|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899818|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899819|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899820|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899821|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899822|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899823|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899824|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899825|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899826|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899827|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899828|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899829|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899830|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899831|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899832|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899833|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899834|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899835|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899836|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899837|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899838|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899839|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899840|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899841|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899842|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899843|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899844|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899845|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899846|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899847|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899848|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899849|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899850|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
911807|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
899851|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899852|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899853|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899854|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899855|NCT01088464|O3|Outcome|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899856|NCT01088464|O2|Outcome|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899857|NCT01088464|O1|Outcome|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899858|NCT01088464|E3|Reported Event|Cohort 3: Necitumumab|Necitumumab 800 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899859|NCT01088464|E2|Reported Event|Cohort 2: Necitumumab|Necitumumab 800 mg administered intravenously every 2 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899860|NCT01088464|E1|Reported Event|Cohort 1: Necitumumab|Necitumumab 600 mg administered intravenously on Days 1 and 8 every 3 weeks of a 6-week cycle. After Cycle 1, participants showing objective response or stable disease were to receive necitumumab at same dose and schedule until disease progression or other withdrawal criteria were met.
899861|NCT01088438|B3|Baseline|Total|Total of all reporting groups
899862|NCT01088438|B2|Baseline|Control|No intervention
899863|NCT01088438|B1|Baseline|Contextualization Workshop|A four-hour course on contextualization.
899864|NCT01088438|P2|Participant Flow|Control|No intervention
899865|NCT01088438|P1|Participant Flow|Contextualization Workshop|A four-hour course on contextualization.
899866|NCT01088438|O2|Outcome|Control|No intervention
899867|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
899868|NCT01088438|O2|Outcome|Control|No intervention
899869|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
899870|NCT01088438|O2|Outcome|Control|No intervention
899871|NCT01088438|O1|Outcome|Contextualization Workshop|A four-hour course on contextualization.
899872|NCT01088438|E2|Reported Event|Control|No intervention
899873|NCT01088438|E1|Reported Event|Contextualization Workshop|A four-hour course on contextualization.
899874|NCT01088399|B4|Baseline|Total|Total of all reporting groups
899875|NCT01088399|B3|Baseline|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899876|NCT01088399|B2|Baseline|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899877|NCT01088399|B1|Baseline|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899878|NCT01088399|P3|Participant Flow||It is not known whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899879|NCT01088399|P2|Participant Flow|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899880|NCT01088399|P1|Participant Flow|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899881|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899882|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899883|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899884|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899885|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899886|NCT01088399|O3|Outcome|Unknown|It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899887|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
900280|NCT01086852|B1|Baseline|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
899888|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899889|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899890|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899891|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899892|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899893|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899894|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899895|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899896|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899897|NCT01088399|O2|Outcome|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899898|NCT01088399|O1|Outcome|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899899|NCT01088399|E3|Reported Event||It is unknown whether participants did or did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899900|NCT01088399|E2|Reported Event|Untreated|Participants did not receive somatropin therapy during the study. No form of intervention was imposed on the participants.
899901|NCT01088399|E1|Reported Event|Somatropin Treated|Participants received somatropin therapy dosed according to the local product label during the study. No form of intervention was imposed on the participants.
899902|NCT01088295|B1|Baseline|Telmisartan|Telmisartan 40mg po daily for 24 weeks
899903|NCT01088295|P1|Participant Flow|Telmisartan|Telmisartan 40mg po daily for 24 weeks
899904|NCT01088295|O1|Outcome|Telmisartan|Telmisartan 40mg po daily for 24 weeks
899905|NCT01088295|E1|Reported Event|Telmisartan|
899906|NCT01087996|B3|Baseline|Total|Total of all reporting groups
899907|NCT01087996|B2|Baseline|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899908|NCT01087996|B1|Baseline|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899909|NCT01087996|P2|Participant Flow|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899910|NCT01087996|P1|Participant Flow|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899911|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899932|NCT01087970|P1|Participant Flow|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 milligrams/square meter (mg/m²) administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin area under curve (AUC) 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899912|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899913|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899914|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899915|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899916|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899917|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899918|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899919|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899920|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899921|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899953|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899954|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899922|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899923|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899924|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899925|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899926|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899927|NCT01087996|O2|Outcome|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899928|NCT01087996|O1|Outcome|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899929|NCT01087996|E2|Reported Event|Auto-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million autologous human mesenchymal stem cells.~Auto-hMSCs : Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899930|NCT01087996|E1|Reported Event|Allo-hMSCs|"Participants will receive an injection of 20 million, 100 million or 200 million allogeneic human mesenchymal stem cells.~Allo-hMSCs : Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter."
899931|NCT01087970|B1|Baseline|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899955|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899956|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
900652|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
899933|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899934|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899935|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899936|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899937|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899938|NCT01087970|O1|Outcome|Cetuximab + Pemetrexed + Carboplatin/Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 or cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899939|NCT01087970|E2|Reported Event|Cetuximab + Pemetrexed + Cisplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Cisplatin 75 mg/m² administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899940|NCT01087970|E1|Reported Event|Cetuximab + Pemetrexed + Carboplatin|"Cetuximab loading dose of 400 mg/m² administered intravenously on Day 1 of Cycle 1; subsequently 250 mg/m² administered intravenously weekly.~Pemetrexed 500 mg/m² administered intravenously on Day 1 of every 21-day cycle, 1 hour after cetuximab.~Carboplatin AUC 5 administered intravenously on Day 1 of every 21-day cycle, 30 minutes after pemetrexed.~Maximum 6 cycles. Participants who did not experience disease progression after 6 cycles continued on cetuximab (250 mg/m² intravenously weekly) monotherapy until disease progression."
899941|NCT01087957|B3|Baseline|Total|Total of all reporting groups
899942|NCT01087957|B2|Baseline|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899943|NCT01087957|B1|Baseline|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899944|NCT01087957|P2|Participant Flow|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899945|NCT01087957|P1|Participant Flow|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899946|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899947|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899948|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899949|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899950|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899951|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899952|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
900281|NCT01086852|P1|Participant Flow|Active Treatment With FACTOR X|Four subjects underwent 4 major surgeries with active treatment (FACTOR X)
899957|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899958|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899959|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899960|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899961|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899962|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899963|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899964|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899965|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899966|NCT01087957|O2|Outcome|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899967|NCT01087957|O1|Outcome|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899968|NCT01087957|E2|Reported Event|WalkAide|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~WalkAide: Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899969|NCT01087957|E1|Reported Event|Ankle-Foot Orthosis (AFO)|"Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)~Ankle-Foot Orthosis (AFO): Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)"
899970|NCT01087944|B1|Baseline|Overall|Participants received PEG-IFN alfa-2a 180 mcg SC once a week either AI or PFS for the first 3 weeks and then switched to the other method of injection for an additional 3 weeks. Participants also received ribavirin according to standard of care per the investigator’s judgment.
899971|NCT01087944|P2|Participant Flow|Sequence 2 (Pre-filled Syringe Then Auto-Injector)|Participants received PEG-IFN 180 mcg /0.5 mL subcutaneously once a week using pre-filled syringe from Week 1-3 in Treatment Period 1 and using autoinjector from Week 4-6 in Treatment Period 2.
899972|NCT01087944|P1|Participant Flow|Sequence 1 (Auto-Injector Then Pre-filled Syringe)|Participants received Peginterferon alfa-2a (PEG-IFN) 180 microgram (mcg) /0.5 milliliter (mL) subcutaneously once a week using autoinjector from Week 1-3 in Treatment Period 1 and using pre-filled syringe from Week 4-6 in Treatment Period 2.
899973|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899974|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899975|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899976|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899977|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899978|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899979|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899980|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
900282|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
899981|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899982|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899983|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899984|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899985|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899986|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899987|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899988|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899989|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899990|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899991|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899992|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899993|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899994|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899995|NCT01087944|O2|Outcome|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899996|NCT01087944|O1|Outcome|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
900236|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
899997|NCT01087944|E2|Reported Event|Pre-filled Syringe|The PFS group includes results from Weeks 1–3 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)and results from Weeks 4–6 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6)
899998|NCT01087944|E1|Reported Event|Autoinjector|The AI group includes results from Weeks 1–3 for participants in Treatment Group A (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by AI for Weeks 1–3, followed by PFS for Weeks 4–6) and results from Weeks 4–6 for participants in Treatment Group B (Participants received 180 mcg/0.5 mL PEG-IFN subcutaneously once a week by PFS for the Weeks 1–3, followed by AI for Weeks 4–6)
899999|NCT01087918|B3|Baseline|Total|Total of all reporting groups
900000|NCT01087918|B2|Baseline|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
900001|NCT01087918|B1|Baseline|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
900002|NCT01087918|P2|Participant Flow|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
900003|NCT01087918|P1|Participant Flow|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
900004|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900005|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900006|NCT01087918|O2|Outcome|First Strength Training, Then RAGT|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900007|NCT01087918|O1|Outcome|First RAGT, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900008|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900009|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900010|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900011|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900012|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900013|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900014|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900015|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900016|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900017|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900018|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900019|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900020|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of strength training 4 times a week
900021|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week
900022|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900023|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900024|NCT01087918|O2|Outcome|Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900025|NCT01087918|O1|Outcome|Robot-assisted Gait Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week.
900026|NCT01087918|E2|Reported Event|Strength Training First, Then Robot-assisted Gait Training|16 sessions of 45 minutes of strength training 4 times a week in first intervention period and 16 sessions of 45 minutes of robot-assisted gait training 4 times a week in second intervention period.
900027|NCT01087918|E1|Reported Event|Robot-assisted Gait Training First, Then Strength Training|16 sessions of 45 minutes of robot-assisted gait training 4 times a week in first intervention period and 16 sessions of 45 minutes of strength training 4 times a week in second intervention period.
900028|NCT01087905|B9|Baseline|Total|Total of all reporting groups
900029|NCT01087905|B8|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900030|NCT01087905|B7|Baseline|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900031|NCT01087905|B6|Baseline|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900032|NCT01087905|B5|Baseline|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900237|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900033|NCT01087905|B4|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900034|NCT01087905|B3|Baseline|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900035|NCT01087905|B2|Baseline|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900036|NCT01087905|B1|Baseline|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900037|NCT01087905|P8|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900038|NCT01087905|P7|Participant Flow|6 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 6 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900039|NCT01087905|P6|Participant Flow|6 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900040|NCT01087905|P5|Participant Flow|6 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 6 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900041|NCT01087905|P4|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum and CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900042|NCT01087905|P3|Participant Flow|2 Weeks of Nicotine Patch+Nicotine Gum , No CMAC|Participants in this randomization group received 2 weeks of nicotine patch plus nicotine gum and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900043|NCT01087905|P2|Participant Flow|2 Weeks of Nicotine Patch Only Plus CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC).
900044|NCT01087905|P1|Participant Flow|2 Weeks of Nicotine Patch Only, No CMAC|Participants in this randomization group received 2 weeks of nicotine patch only and standard quitline cessation counseling consisting of 4 proactive counseling calls (but no Cognitive Medication Adherence Counseling (CMAC).
900045|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
900046|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
900047|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
900048|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
900049|NCT01087905|O4|Outcome|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
900050|NCT01087905|O3|Outcome|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
900051|NCT01087905|O2|Outcome|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
900052|NCT01087905|O1|Outcome|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
900053|NCT01087905|O6|Outcome|Standard Cessation Counseling Plus CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls plus Cognitive Medication Adherence Counseling (CMAC). This intervention is considered to be the enhanced intervention in terms of cessation counseling; it will be compared to the standard cessation counseling intervention which consists of Standard Cessation Counseling only (no CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
900054|NCT01087905|O5|Outcome|Standard Cessation Counseling (No CMAC)|Participants in this intervention group received standard quitline cessation counseling consisting of 4 proactive counseling calls. This intervention is considered to be the standard intervention in terms of cessation counseling; it will be compared to the enhanced cessation counseling intervention which consists of Standard Cessation Counseling plus Cognitive Medication Adherence Counseling (CMAC). Approximately half the total sample was randomized to the standard intervention (Standard Cessation Counseling, No CMAC) and half to the enhanced intervention (Standard Cessation Counseling plus CMAC).
900055|NCT01087905|O4|Outcome|NRT Combination Therapy (Nicotine Patch Plus Nicotine Gum)|Participants in this intervention group received Combination Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch plus Nicotine Gum. This intervention is considered to be the enhanced intervention in terms of type of NRT; it will be compared to the standard NRT type intervention which is NRT Monotherapy consisting of the Nicotine Patch Only. Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
900089|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900056|NCT01087905|O3|Outcome|NRT Monotherapy (Nicotine Patch Only)|Participants in this intervention group received a single Nicotine Replacement Therapy (NRT) consisting of the Nicotine Patch only. This intervention is considered to be the standard intervention in terms of type of NRT; it will be compared to the enhanced NRT type intervention which is combination NRT consisting of Nicotine Patch plus Nicotine Gum (Combo NRT). Approximately half the total sample was randomized to the standard intervention (Nicotine Patch Only) and half to the enhanced intervention (Nicotine Patch plus Nicotine Gum).
900057|NCT01087905|O2|Outcome|Six Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a six-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the enhanced intervention in terms of duration of NRT; it will be compared to the standard NRT duration intervention which is two weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
900058|NCT01087905|O1|Outcome|Two Weeks of Nicotine Replacement Therapy (NRT)|Participants in this intervention group received a two-week supply of Nicotine Replacement Therapy (NRT). This intervention is considered to be the standard intervention in terms of duration of NRT; it will be compared to the enhanced NRT duration intervention which is six weeks of NRT. Approximately half the total sample was randomized to the standard intervention (two weeks of NRT) and half to the enhanced intervention (six weeks of NRT).
900059|NCT01087905|E4|Reported Event|Six Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Six Weeks of Nicotine Patch plus Nicotine Gum.
900060|NCT01087905|E3|Reported Event|Six Weeks of Nicotine Patch Only|Participants in this treatment group received Six Weeks of Nicotine Patch Only.
900061|NCT01087905|E2|Reported Event|Two Weeks of Combination NRT (Nicotine Patch + Nicotine Gum)|Participants in this treatment group received Two Weeks of Nicotine Patch plus Nicotine Gum.
900062|NCT01087905|E1|Reported Event|Two Weeks of Nicotine Patch Only|Participants in this treatment group received Two Weeks of Nicotine Patch Only.
900063|NCT01087814|B3|Baseline|Total|Total of all reporting groups
900064|NCT01087814|B2|Baseline|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
900065|NCT01087814|B1|Baseline|Efavirenz|Both arms received both versions of the drug during the course of the study.
900066|NCT01087814|P2|Participant Flow|Over-encapsulated Efavirenz First, Then Efavirenz|This arm received over-encapsulated efavirenz for five days, then efavirenz for five days.
900067|NCT01087814|P1|Participant Flow|Efavirenz First, Then Over-encapsulated Efavirenz|This arm received efavirenz for five days, then over-encapsulated efavirenz for five days.
900068|NCT01087814|O2|Outcome|Over-encapsulated Efavirenz|All subjects took over-encapsulated efavirenz.
900069|NCT01087814|O1|Outcome|Efavirenz (Tablet)|All subjects took efavirenz.
900070|NCT01087814|E2|Reported Event|Over-encapsulated Efavirenz|Both arms received both versions of the drug over the course of the study.
900071|NCT01087814|E1|Reported Event|Efavirenz|Both arms received both versions of the drug during the course of the study.
900072|NCT01087801|B3|Baseline|Total|Total of all reporting groups
900073|NCT01087801|B2|Baseline|Placebo|Saline for Injection 0.1 mL/kg IV
900074|NCT01087801|B1|Baseline|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
900075|NCT01087801|P2|Participant Flow|Placebo|Saline for Injection 0.1 mL/kg IV
900076|NCT01087801|P1|Participant Flow|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
900077|NCT01087801|O2|Outcome|Placebo|Saline for Injection 0.1 mL/kg IV
900078|NCT01087801|O1|Outcome|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
900079|NCT01087801|E2|Reported Event|Placebo|Saline for Injection 0.1 mL/kg IV
900080|NCT01087801|E1|Reported Event|ChiRhoStim|Human Secretin for Injection 0.1 mL/kg IV
900081|NCT01087788|B4|Baseline|Total Title|
900082|NCT01087788|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900083|NCT01087788|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900084|NCT01087788|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900085|NCT01087788|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900086|NCT01087788|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900087|NCT01087788|P1|Participant Flow|Placebo|"Matching Placebo (PBO) to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900088|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
900283|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
900090|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900091|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900092|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
900093|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900094|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900095|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900096|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
900097|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900098|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900099|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900100|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900101|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900102|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900103|NCT01087788|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (Randomized Set)|"This combined group includes subjects of the two treatment arms CZP 200 mg Q2W and CZP 400 mg Q4W used in some analyses.~Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind."
900104|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900105|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900106|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900107|NCT01087788|O3|Outcome|CZP 400 mg Q4W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind."
900238|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900108|NCT01087788|O2|Outcome|CZP 200 mg Q2W (Randomized Set)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind."
900109|NCT01087788|O1|Outcome|Placebo (Randomized Set)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group and were re-randomized to either CZP 200 mg Q2W or CZP 400 mg Q4W arm on Week 16.~After 24 weeks, all subjects were re-randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W)."
900110|NCT01087788|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg Q2W and arm All CZP 400 mg Q4W.
900111|NCT01087788|E2|Reported Event|All CZP 400 mg Q4W|"This arm includes all subjects who were randomized to CZP 400 mg Q4W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 400 mg Q4W.~Subjects received two injections of Placebo every four weeks in between the two injections of 200 mg CZP to maintain the study blind."
900112|NCT01087788|E1|Reported Event|All CZP 200 mg Q2W|"This arm includes all subjects who were randomized to CZP 200 mg Q2W at Baseline and those subjects who escaped or were re-randomized from Placebo to CZP 200 mg Q2W.~Subjects received one injection of 200 mg CZP and one injection of Placebo every two weeks to maintain the study blind."
900113|NCT01087762|B4|Baseline|Total Title|
900114|NCT01087762|B3|Baseline|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900115|NCT01087762|B2|Baseline|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900116|NCT01087762|B1|Baseline|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900117|NCT01087762|P5|Participant Flow|All CZP 400 mg|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900118|NCT01087762|P4|Participant Flow|All CZP 200 mg|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900119|NCT01087762|P3|Participant Flow|CZP 400 mg Q4W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900120|NCT01087762|P2|Participant Flow|CZP 200 mg Q2W|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900121|NCT01087762|P1|Participant Flow|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900122|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900123|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900124|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900125|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
911808|NCT01055704|O2|Outcome|Codeine 30 mg|
900126|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900127|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900128|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900129|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900130|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900131|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900132|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900133|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900134|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900135|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900136|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900137|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900138|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900139|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900239|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900284|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
900140|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900141|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900142|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900143|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900144|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900145|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900146|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900147|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900148|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900149|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900150|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900151|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900152|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900153|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900171|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
900277|NCT01086969|E3|Reported Event|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
900154|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900155|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900156|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900157|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900158|NCT01087762|O4|Outcome|CZP 200 mg Q2W and CZP 400 mg Q4W (FAS)|"This arm shows a combination of arm CZP 200 mg Q2W and arm CZP 400 mg Q4W. Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W)/ 400 mg CZP sc every 4 weeks (Q4W) from Week 6/ Week 8 onwards.~Subjects in both CZP arms received additional placebo injections to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900159|NCT01087762|O3|Outcome|CZP 400 mg Q4W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 400 mg CZP sc every 4 weeks (Q4W) from Week 8 onwards.~Subjects received 2 injections of Placebo every 4 weeks in between the 2 injections of 200 mg CZP to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900160|NCT01087762|O2|Outcome|CZP 200 mg Q2W (FAS)|"Subjects received Certolizumab Pegol (CZP) 400 mg subcutaneous (sc) on Weeks 0, 2 and 4, followed by 200 mg CZP sc every 2 weeks (Q2W) from Week 6 onwards.~At every visit, subjects received one injection of 200 mg CZP and one injection of Placebo to maintain the study blind.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900161|NCT01087762|O1|Outcome|Placebo (FAS)|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900162|NCT01087762|E4|Reported Event|Placebo|"Matching Placebo to Certolizumab Pegol (CZP) injections from Week 0 to Week 24. Placebo subjects who did not achieve certain predefined response criteria at both Weeks 14 and 16 left the Placebo group on Week 16.~After 24 weeks, all subjects were randomized to active treatment with CZP 200 mg every two weeks (Q2W) or CZP 400 mg every four weeks (Q4W).~Placebo : Matching Placebo to CZP injection."
900163|NCT01087762|E3|Reported Event|All CZP 200 mg + 400 mg|This arm shows all patients treated with Certolizumab Pegol (CZP) at least once. Hence, this arm is a combination of arm All CZP 200 mg and arm All CZP 400 mg.
900164|NCT01087762|E2|Reported Event|All CZP 400 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (400 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 400 mg Q4W : 400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W)."
900165|NCT01087762|E1|Reported Event|All CZP 200 mg (Safety Analysis)|"All subjects who received CZP at the specified dose (200 mg) at some point during the study, including subjects who were originally randomized to receive placebo and were switched to CZP at Week 16 or Week 24.~Placebo : Matching Placebo to CZP injection.~CZP 200 mg Q2W : 200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W)."
900166|NCT01087736|B3|Baseline|Total|Total of all reporting groups
900167|NCT01087736|B2|Baseline|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
900168|NCT01087736|B1|Baseline|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
900169|NCT01087736|P2|Participant Flow|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
900170|NCT01087736|P1|Participant Flow|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
900278|NCT01086969|E2|Reported Event|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
900172|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
900173|NCT01087736|O2|Outcome|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
900174|NCT01087736|O1|Outcome|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
900175|NCT01087736|E2|Reported Event|Placebo|Placebo: Placebo pills prepared by the UCSF pharmacy were indistinguishable from the topiramate pills used in that arm. The dosing of placebo pills followed the same regimen as outlined for the topiramate arm. In the event of a safety issue, there would be a procedure for unblinding only that participant.
900176|NCT01087736|E1|Reported Event|Topiramate|Topiramate: topiramate titrated up over 5 weeks, beginning at 25 mg per day, and increased in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Upon completing the 6 week maintenance period dosage was tapered off over a 7-day period (Week 12).
900177|NCT01087723|B3|Baseline|Total|Total of all reporting groups
900178|NCT01087723|B2|Baseline|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900179|NCT01087723|B1|Baseline|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900180|NCT01087723|P2|Participant Flow|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of ST segment elevation acute coronary syndrome (STE-ACS ), not including bivalirudin: unfractionated heparin (UFH) (100 international units/kg [IU/kg] without glycoprotein IIb/IIIa inhibitor [GPI] and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-micrograms/kilogram [μg/kg] IV boluses with a 10-minute [min] interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or low molecular weight heparin (LMWH) with or without GPI and is referred to as heparins with optional GPI.”"
900181|NCT01087723|P1|Participant Flow|Bivalirudin|Given immediately upon enrolment as an intravenous (IV) bolus of 0.75 milligrams/kilogram (mg/kg), followed immediately by an infusion of 1.75 mg/kg/hour (mg/kg/h). This infusion was to be run continuously until completion of percutaneous coronary intervention (PCI), at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900182|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900183|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900184|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900185|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900186|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900187|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900188|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900189|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900190|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900191|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900192|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900193|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900194|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900195|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900196|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900197|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900198|NCT01087723|O2|Outcome|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900199|NCT01087723|O1|Outcome|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900200|NCT01087723|E2|Reported Event|Standard of Care: Heparins With Optional GPI|"Standard-of-care anti-thrombotic therapy as outlined in the European Society of Cardiology Dosing Guidelines for Management of STE-ACS, not including bivalirudin: UFH (100 international IU/kg without GPI and 60 IU/kg with GPI). Any of the following approved GPIs were used either as a routine strategy or as a bail out: eptifibatide (two 180-μg/kg IV boluses with a 10-min interval followed by an infusion of 2.0 μg/kg/min for 72-96 hours); tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18-24 hours); or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours [maximum dose of 10 μg/min]).~For this study, the control consisted of treatment with UFH or LMWH with or without GPI and is referred to as heparins with optional GPI.”"
900201|NCT01087723|E1|Reported Event|Bivalirudin|Given immediately upon enrollment as an IV bolus of 0.75 mg/kg, followed immediately by an infusion of 1.75 mg/kg/h. This infusion was to be run continuously until completion of PCI, at which time the infusion was reduced to 0.25 mg/kg/h for at least 4 hours. An optional PCI-dose infusion of 1.75 mg/kg/h was also permitted for up to 4 hours at the discretion of the operator.
900202|NCT01087541|B3|Baseline|Total|Total of all reporting groups
900203|NCT01087541|B2|Baseline|Control Group|Usual healthcare of diabetics patients
900204|NCT01087541|B1|Baseline|Intervention|Behavioural program of education for health professionals of the study
900205|NCT01087541|P2|Participant Flow|Control Group|Usual healthcare of diabetics patients
900206|NCT01087541|P1|Participant Flow|Intervention|Behavioural program of education for health professionals of the study
900207|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
900208|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
900209|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
900210|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
900211|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
900212|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
900213|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
900214|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
900215|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
900216|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
900217|NCT01087541|O2|Outcome|Control Group|Usual healthcare of diabetics patients
900218|NCT01087541|O1|Outcome|Intervention|Behavioural program of education for health professionals of the study
900219|NCT01087541|E2|Reported Event|Control Group|Usual healthcare
900220|NCT01087541|E1|Reported Event|Intervention Group|Intervention group: educational program
900221|NCT01087528|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
900222|NCT01087528|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
900223|NCT01087528|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
900224|NCT01087528|E1|Reported Event|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison.."
900225|NCT01087502|B3|Baseline|Total|Total of all reporting groups
900226|NCT01087502|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900227|NCT01087502|B1|Baseline|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900228|NCT01087502|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900229|NCT01087502|P1|Participant Flow|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900230|NCT01087502|O1|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900231|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900232|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900233|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900234|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900235|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900240|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900241|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900242|NCT01087502|O1|Outcome|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900243|NCT01087502|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900244|NCT01087502|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900245|NCT01087502|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
900246|NCT01087502|E1|Reported Event|Placebo/Glimepiride|Patients randomized to receive treatment with matching placebo for 12 weeks and then switch to glimepiride for further 40 weeks.
900247|NCT01087489|B1|Baseline|All Study Participants|Each participant was randomly assigned to receive either anesthetic preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day.
900248|NCT01087489|P2|Participant Flow|Unilateral|Each participant was randomly assigned to receive an intravitreal injection with 4% lidocaine prep on one visit and 3.5% lidocaine gel on the next visit.
900249|NCT01087489|P1|Participant Flow|Bilateral|Participants were given bilateral injections with 4% lidocaine prep in one eye and 3.5% lidocaine gel in the other.
900250|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
900251|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
900252|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
900253|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
900254|NCT01087489|O2|Outcome|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
900255|NCT01087489|O1|Outcome|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
900256|NCT01087489|E2|Reported Event|3.5% Ophthalmic Lidocaine Gel|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3.5% ophthalmic lidocaine gel to the injection site.
900257|NCT01087489|E1|Reported Event|4% Liquid Lidocaine Method|Each participant was randomly assigned to receive this preparation during one of two consecutive intravitreal injection (if unilateral disease) or in one eye if requiring bilateral injections given on the same day. This method involved application of 0.5% proparacaine and then 3 cotton swabs soaked in 4% liquid lidocaine applied with moderate pressure to the site of injection.
900258|NCT01086969|B4|Baseline|Total|Total of all reporting groups
900259|NCT01086969|B3|Baseline|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
900260|NCT01086969|B2|Baseline|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
900261|NCT01086969|B1|Baseline|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
900262|NCT01086969|P3|Participant Flow|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
900263|NCT01086969|P2|Participant Flow|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
900264|NCT01086969|P1|Participant Flow|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
900265|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
900266|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
900267|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
900268|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
900269|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
900270|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
900271|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
900272|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
900273|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
900274|NCT01086969|O3|Outcome|Age 18 to 55 Years Group|Participants aged 18 to 55 years at enrollment
900275|NCT01086969|O2|Outcome|Age 12 to 17 Years Group|Participants aged 12 to 17 years at enrollment.
900276|NCT01086969|O1|Outcome|Age 2 to 11 Years Group|Participants at age 2 to 11 years on enrollment.
900286|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
900287|NCT01086852|O1|Outcome|Active Treatment With FACTOR X|Four patients underwent 4 major surgeries with active treatment (FACTOR X)
900288|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
900289|NCT01086852|O1|Outcome|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
900290|NCT01086852|E1|Reported Event|FACTOR X|"Human Coagulation Factor X~FACTOR X: Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.~Post surgery- FX trough levels of 50% should be achieved.~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
900291|NCT01086761|B6|Baseline|Total|Total of all reporting groups
900292|NCT01086761|B5|Baseline|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900293|NCT01086761|B4|Baseline|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900294|NCT01086761|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900295|NCT01086761|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900296|NCT01086761|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900297|NCT01086761|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
900298|NCT01086761|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900299|NCT01086761|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900300|NCT01086761|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900301|NCT01086761|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900302|NCT01086761|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900303|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900304|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900305|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900306|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900307|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900308|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900309|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900310|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900311|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900312|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900313|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900314|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900315|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900316|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900317|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900318|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900319|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900320|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900321|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900322|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900323|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900324|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900325|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900326|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900327|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900328|NCT01086761|O5|Outcome|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900329|NCT01086761|O4|Outcome|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900330|NCT01086761|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900331|NCT01086761|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900332|NCT01086761|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900333|NCT01086761|O1|Outcome|MP0112|Single intravitreal injection of MP0112 in the study eye of one of the following doses: 0.04 mg, 0.15 mg, 0.4 mg, 1.0 mg or 2.0 mg.
900334|NCT01086761|E5|Reported Event|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
900335|NCT01086761|E4|Reported Event|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
900336|NCT01086761|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
900337|NCT01086761|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
900338|NCT01086761|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
900339|NCT01086605|B3|Baseline|Total|Total of all reporting groups
900340|NCT01086605|B2|Baseline|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900341|NCT01086605|B1|Baseline|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900342|NCT01086605|P2|Participant Flow|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900343|NCT01086605|P1|Participant Flow|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900344|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900345|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900346|NCT01086605|O1|Outcome|Arm I/Group A + Arm II/Group B|"Arm I/Group A: Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Arm II/Group B: Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity."
900347|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900348|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900349|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900350|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900351|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900352|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900353|NCT01086605|O2|Outcome|Arm II/Group B (Pixantrone IV Days 1, 8, and 15)|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900354|NCT01086605|O1|Outcome|Arm I/Group A (Pixantrone IV Day 1)|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900355|NCT01086605|E2|Reported Event|Arm II/Group B|Patients receive 85 mg/m^2 pixantrone dimaleate IV over 1 hour on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900356|NCT01086605|E1|Reported Event|Arm I/Group A|Patients receive 180 mg/m^2 pixantrone dimaleate IV over 1 hour on day 1. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
900357|NCT01086475|B3|Baseline|Total|Total of all reporting groups
900358|NCT01086475|B2|Baseline|Placebo|"Subjects randomized to placebo arm will receive placebo pill 30 minutes prior to each of ten Social Skills Training Sessions~Placebo: Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions"
900359|NCT01086475|B1|Baseline|D-cycloserine|"Subjects randomized to D-cycloserine will be administered 50 mg 30 minutes prior to each of ten Social Skills Training Sessions~D-cycloserine: 50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions"
900360|NCT01086475|P2|Participant Flow|Placebo|Subjects who received placebo
900361|NCT01086475|P1|Participant Flow|D-cycloserine|Subjects who received d-cycloserine
900362|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
900363|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
900364|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
900365|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
900366|NCT01086475|O2|Outcome|Placebo|Subjects who received placebo
900367|NCT01086475|O1|Outcome|D-cycloserine|Subjects who received d-cycloserine
900368|NCT01086475|E2|Reported Event|Placebo|Subjects who received placebo
900369|NCT01086475|E1|Reported Event|D-cycloserine|Subjects who received d-cycloserine
900370|NCT01086423|B4|Baseline|Total|Total of all reporting groups
900565|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900653|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
900371|NCT01086423|B3|Baseline|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900372|NCT01086423|B2|Baseline|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900373|NCT01086423|B1|Baseline|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900374|NCT01086423|P3|Participant Flow|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900375|NCT01086423|P2|Participant Flow|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900376|NCT01086423|P1|Participant Flow|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900377|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900378|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900379|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900380|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900381|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900382|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900383|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900384|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900385|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900386|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900387|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900388|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900389|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900390|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900391|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900392|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900393|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900394|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900395|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900396|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900397|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900398|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900399|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900400|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900401|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900402|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900403|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900404|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900405|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900406|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900407|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900408|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900409|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900410|NCT01086423|O3|Outcome|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900411|NCT01086423|O2|Outcome|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
900412|NCT01086423|O1|Outcome|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900413|NCT01086423|E3|Reported Event|Infanrix-Hib+Poliorix Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-Hib vaccine co-administered with Poliorix™ vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right or left thigh, respectively.
900414|NCT01086423|E2|Reported Event|Infanrix-IPV+Hib 2 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 3, 4 and 5 months of age, administered intramuscularly in the upper side of the right thigh.
911809|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
900415|NCT01086423|E1|Reported Event|Infanrix-IPV+Hib 1 Group|Healthy male or female infants, between and including 60 and 90 days of age at the time of the first study visit, received 3 doses of Infanrix™-IPV+Hib vaccine at 2, 3 and 4 months of age, administered intramuscularly in the upper side of the right thigh.
900416|NCT01086410|B5|Baseline|Total|Total of all reporting groups
900417|NCT01086410|B4|Baseline|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900418|NCT01086410|B3|Baseline|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900419|NCT01086410|B2|Baseline|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900420|NCT01086410|B1|Baseline|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900421|NCT01086410|P4|Participant Flow|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900422|NCT01086410|P3|Participant Flow|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900423|NCT01086410|P2|Participant Flow|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900424|NCT01086410|P1|Participant Flow|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900425|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900426|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900427|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900428|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900429|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900430|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900431|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900432|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900433|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900434|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900435|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900436|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900437|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900438|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900439|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900440|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900441|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900442|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900443|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900444|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900445|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900446|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900447|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900448|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900449|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900450|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900451|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
911810|NCT01055704|O4|Outcome|Placebo|
900452|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900453|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900454|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900455|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900456|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900457|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900458|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900459|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900460|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900461|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900462|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900463|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900464|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900465|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900466|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900467|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900468|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900469|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
911811|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
900470|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900471|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900472|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900473|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900474|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900475|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900476|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900477|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900478|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900479|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900480|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900481|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900482|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900483|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900484|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900485|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900486|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900487|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900488|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900489|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900490|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900491|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900492|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900493|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900494|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900495|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900496|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900497|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900498|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900499|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900500|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900501|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900502|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900503|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900504|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900505|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
911812|NCT01055704|O2|Outcome|Codeine 30 mg|
900506|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900507|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900508|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900509|NCT01086410|O4|Outcome|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900510|NCT01086410|O3|Outcome|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900511|NCT01086410|O2|Outcome|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900512|NCT01086410|O1|Outcome|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900513|NCT01086410|E4|Reported Event|Prednisolone 10 mg AM|Participants received placebo via a DPI for 6 weeks, plus a prednisolone 10 milligram (mg) capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation of placebo from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one Prednisolone capsule each morning (AM) on the last 7 days of treatment.
900514|NCT01086410|E3|Reported Event|FF/VI 200/25 µg PM|Participants received FF/VI 200/25 µg via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900515|NCT01086410|E2|Reported Event|FF/VI 100/25 µg PM|Participants received Fluticasone Furoate/Vilanterol (FF/VI) 100/25 micrograms (µg) via a DPI for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening (PM) for 6 weeks and to take one placebo capsule each morning (AM) on the last 7 days of treatment.
900516|NCT01086410|E1|Reported Event|Placebo|Participants received placebo via a Dry Powder Inhaler (DPI) for 6 weeks, plus a placebo capsule on the last 7 days of treatment. Participants were instructed to self-administer one inhalation from the DPI once daily at approximately the same time each evening for 6 weeks and to take one placebo capsule each morning on the last 7 days of treatment.
900517|NCT01086384|B3|Baseline|Total|Total of all reporting groups
900518|NCT01086384|B2|Baseline|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900519|NCT01086384|B1|Baseline|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900520|NCT01086384|P3|Participant Flow|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900521|NCT01086384|P2|Participant Flow|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900522|NCT01086384|P1|Participant Flow|FP 250 µg/ICS|Japanese participants using fluticasone propionate (FP)/salmeterol 250/50 micrograms (µg) twice daily received open-label FP 250 µg to ensure they continued their inhaled corticosteroid (ICS) therapy at a fixed dose during the 2-week Run-in Period. All other participants continued to use their current ICS therapy at a fixed dose during the 2-week Run-in Period. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Run-in Period.
900523|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900524|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900566|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900525|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900526|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900527|NCT01086384|O2|Outcome|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900528|NCT01086384|O1|Outcome|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900529|NCT01086384|E2|Reported Event|FF/VI 100/25 µg|Participants received FF/vilanterol (VI) 100/25 µg inhalation powder via a DPI once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900530|NCT01086384|E1|Reported Event|FF 100 µg|Participants received fluticasone furoate (FF) 100 microgram (µg) inhalation powder via a dry powder inhaler (DPI) once daily in the evening. Short-acting beta2-agonist inhalation aerosol (albuterol/salbutamol) was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
900531|NCT01086215|B5|Baseline|Total|Total of all reporting groups
900532|NCT01086215|B4|Baseline|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
900533|NCT01086215|B3|Baseline|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
900534|NCT01086215|B2|Baseline|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
900535|NCT01086215|B1|Baseline|Limb Ischemia|Patients presenting with limb ischemia for treatment
900536|NCT01086215|P4|Participant Flow|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
900537|NCT01086215|P3|Participant Flow|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
900538|NCT01086215|P2|Participant Flow|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
900539|NCT01086215|P1|Participant Flow|Limb Ischemia|Patients presenting with limb ischemia for treatment
900540|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
900541|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
900542|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
900543|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
900544|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
900545|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
900546|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
900547|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
900548|NCT01086215|O4|Outcome|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
900549|NCT01086215|O3|Outcome|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
900550|NCT01086215|O2|Outcome|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
900551|NCT01086215|O1|Outcome|Limb Ischemia|Patients presenting with limb ischemia for treatment
900552|NCT01086215|E4|Reported Event|Other Thrombotic Conditions|Patients presenting with a thrombotic condition other than limb ischemia, deep vein thrombosis or thrombosed hemodialysis access for treatment
900553|NCT01086215|E3|Reported Event|Hemodialysis Access|Patients presenting with thrombosed hemodialysis access for treatment
900554|NCT01086215|E2|Reported Event|Deep Vein Thrombosis|Patients presenting with deep vein thrombosis for treatment
900555|NCT01086215|E1|Reported Event|Limb Ischemia|Patients presenting with limb ischemia for treatment
900556|NCT01086033|B1|Baseline|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900557|NCT01086033|P1|Participant Flow|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900558|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900559|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900560|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900561|NCT01086033|O1|Outcome|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900562|NCT01086033|O3|Outcome|No Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with No Response according to EULAR criteria.
900563|NCT01086033|O2|Outcome|Moderate Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Moderate Response per EULAR criteria.
900564|NCT01086033|O1|Outcome|Good Response|Rheumatoid Arthritis patients treated with Humira (adalimumab) with a Good Response per EULAR criteria.
900567|NCT01086033|E1|Reported Event|Humira|Participants with rheumatoid arthritis treated with Humira (adalimumab) as prescribed by the rheumatologist in the setting of routine clinical care.
900568|NCT01085968|B3|Baseline|Total|Total of all reporting groups
900569|NCT01085968|B2|Baseline|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900570|NCT01085968|B1|Baseline|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900571|NCT01085968|P2|Participant Flow|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900572|NCT01085968|P1|Participant Flow|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900573|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900574|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900575|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900576|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900577|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900578|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900579|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900580|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900581|NCT01085968|O2|Outcome|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900582|NCT01085968|O1|Outcome|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900583|NCT01085968|E2|Reported Event|Control Subjects|"Age matched controls~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900584|NCT01085968|E1|Reported Event|PD Subjects|"PD subjects~PC based training: Subjects sit at a computer and type a string of numbers that appears on the screen. They are then instructed to repeat the string from memory. As performance improves (# correct), the strings of numbers get longer."
900585|NCT01085903|B3|Baseline|Total|Total of all reporting groups
900586|NCT01085903|B2|Baseline|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline, CPS, and Post CPS and then are randomized to modafinil or placebo.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition. Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
900587|NCT01085903|B1|Baseline|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
900588|NCT01085903|P3|Participant Flow|Stroke Subjects: Modafinil Then Placebo|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
900589|NCT01085903|P2|Participant Flow|Stroke Subjects: Placebo Then Modafinil|"Denotes sequence Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
900590|NCT01085903|P1|Participant Flow|Normal Subjects Baseline|"Normal subjects are persons without stroke who receive baseline, Cold Pressor Stimulation (CPS), Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition."
900591|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patientseal for three days administered only to stroke patients"
900592|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
900593|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
900594|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900595|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline and CPS conditions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900596|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
900597|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
900598|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
900599|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive baseline and CPS conditions before being randomized to placebo and modafinil.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900600|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900601|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
900602|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients"
900603|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
900604|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive the baseline and CPS conditions and then are randomized to the placebo and modafinil interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900605|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900606|NCT01085903|O5|Outcome|Stroke Subjects Placebo vs Modafinil|"Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients"
900643|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
900644|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
900607|NCT01085903|O4|Outcome|Stroke Subjects: Placebo|Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
900608|NCT01085903|O3|Outcome|Stroke Subjects: Modafinil|Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients
900609|NCT01085903|O2|Outcome|Stroke Subjects: Baseline vs CPS|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900610|NCT01085903|O1|Outcome|Normal Subjects: Baseline vs CPS|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds."
900611|NCT01085903|E2|Reported Event|Stroke Subjects|"Stroke subjects are persons who have had a stroke affecting the right hemisphere and are subject to neglect or dysphagia who receive modafinil, placebo, baseline, CPS, Post CPS and Follow up interventions.~Modafinil: 200 mg once daily with morning meal for three days administered only to stroke patients~Placebo: Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
900612|NCT01085903|E1|Reported Event|Normal Subjects|"Normal subjects are persons without stroke who receive baseline, CPS, Post CPS and Follow up interventions.~Baseline: Observations made at baseline before any intervention~CPS: Submerging each participant’s foot into ice water (36-44 F) for 50 seconds.~Post CPS: 20 minutes following the CPS condition.~Follow up: Follow up testing occurred at 3 months"
900613|NCT01085825|B3|Baseline|Total|Total of all reporting groups
900614|NCT01085825|B2|Baseline|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900615|NCT01085825|B1|Baseline|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900616|NCT01085825|P2|Participant Flow|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900617|NCT01085825|P1|Participant Flow|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900618|NCT01085825|O2|Outcome|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900619|NCT01085825|O1|Outcome|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900620|NCT01085825|E2|Reported Event|Electric Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900621|NCT01085825|E1|Reported Event|Manual Vacuum Aspiration|D & C abortion: Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
900622|NCT01085786|B3|Baseline|Total|Total of all reporting groups
900623|NCT01085786|B2|Baseline|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
900624|NCT01085786|B1|Baseline|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
900625|NCT01085786|P2|Participant Flow|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
900626|NCT01085786|P1|Participant Flow|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
900627|NCT01085786|O2|Outcome|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
900628|NCT01085786|O1|Outcome|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
900629|NCT01085786|E2|Reported Event|14-day Hybrid Treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
900630|NCT01085786|E1|Reported Event|14-day Sequential Treatment|One in which the first component consists of a proton pump inhibitor and amoxicillin given for 7 days followed by the PPI, clarithromycin and metronidazole for 7 days.
900631|NCT01085760|B5|Baseline|Total|Total of all reporting groups
900632|NCT01085760|B4|Baseline|High Dose Metronidazole|metronidazole 500 mg 3 times a day
900633|NCT01085760|B3|Baseline|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
900634|NCT01085760|B2|Baseline|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
900635|NCT01085760|B1|Baseline|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
900636|NCT01085760|P4|Participant Flow|High Dose Metronidazole|metronidazole 500 mg 3 times a day
900637|NCT01085760|P3|Participant Flow|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
900638|NCT01085760|P2|Participant Flow|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
900639|NCT01085760|P1|Participant Flow|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
900640|NCT01085760|O4|Outcome|High Dose Metronidazole|Metronidazole 500 mg 3 times a day
900641|NCT01085760|O3|Outcome|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
900642|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
900654|NCT01085760|O2|Outcome|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
900655|NCT01085760|O1|Outcome|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
900656|NCT01085760|E4|Reported Event|High Dose Metronidazole|metronidazole 500 mg 3 times a day
900657|NCT01085760|E3|Reported Event|Low Dose Metronidazole|Metronidazole 250 mg 3 times a day
900658|NCT01085760|E2|Reported Event|High Dose Vancomycin|Vancomycin 250 mg 4 times a day
900659|NCT01085760|E1|Reported Event|Low Dose Vancomycin|Vancomycin 125 mg 4 times a day
900660|NCT01085734|B3|Baseline|Total|Total of all reporting groups
900661|NCT01085734|B2|Baseline|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
900662|NCT01085734|B1|Baseline|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
900663|NCT01085734|P2|Participant Flow|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
900664|NCT01085734|P1|Participant Flow|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 micros
900665|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
900666|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
900667|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
900668|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns
900669|NCT01085734|O2|Outcome|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
900670|NCT01085734|O1|Outcome|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if central edema was greater than 250 microns.
900671|NCT01085734|E2|Reported Event|Group 2|Group 2 receives intravitreal Avastin at baseline followed by Osurdex at week 1. Retreatment with Avastin was given at monthly intervals wehn the OCT central subfield thickness was greater than 250 microns. Retreatment with Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 microns.
900672|NCT01085734|E1|Reported Event|Group 1|Group 1 receives intravitreal Avastin at baseline followed by sham Osurdex at week 1. Additional treatment with Avastin was given at monthly intervals when the OCT central subfield thickness was greater than 250 microns. Retreatment with sham Osurdex occurred at month 4 one week after Avastin treatment if cnetral edema was greater than 250 micros
900673|NCT01085682|B3|Baseline|Total|Total of all reporting groups
900674|NCT01085682|B2|Baseline|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
900675|NCT01085682|B1|Baseline|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
900676|NCT01085682|P2|Participant Flow|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
900677|NCT01085682|P1|Participant Flow|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
900678|NCT01085682|O2|Outcome|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
900679|NCT01085682|O1|Outcome|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
900680|NCT01085682|E2|Reported Event|Standard Care|Standard care: In standard care group, counseling sessions are conducted only 6 times for 4 years
900681|NCT01085682|E1|Reported Event|Lifestyle Counseling|Lifestyle counseling: In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
900713|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
911813|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
900909|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900682|NCT01085643|B1|Baseline|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900683|NCT01085643|P1|Participant Flow|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900684|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900685|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900686|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900687|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900688|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900689|NCT01085643|O1|Outcome|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900690|NCT01085643|E1|Reported Event|Placebo Then Lubiprostone|Subjects will receive the two capsules, lubiprostone and placebo, 24 micrograms each, three hours apart during High Resolution Manometry recording. Subjects will receive each capsule only once and will not know which order they're receiving them in, although, placebo capsule has to be given first to avoid a carry over effect of lubiprostone.
900691|NCT01085591|B4|Baseline|Total|Total of all reporting groups
900692|NCT01085591|B3|Baseline|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900693|NCT01085591|B2|Baseline|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
900694|NCT01085591|B1|Baseline|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900695|NCT01085591|P3|Participant Flow|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900696|NCT01085591|P2|Participant Flow|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
900697|NCT01085591|P1|Participant Flow|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900698|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900699|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900700|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900701|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900702|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900703|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900704|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900705|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900706|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900707|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900708|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900709|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900710|NCT01085591|O3|Outcome|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900711|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900712|NCT01085591|O1|Outcome|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900714|NCT01085591|O2|Outcome|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900715|NCT01085591|O1|Outcome|CB-183,315, 125mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900716|NCT01085591|E3|Reported Event|Oral Vancomycin, 125 mg|125 mg vancomycin administered orally four times a day for 10 days
900717|NCT01085591|E2|Reported Event|CB-183,315, 250 mg|250 mg CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days.
900718|NCT01085591|E1|Reported Event|CB-183,315, 125 mg|125 milligrams (mg) CB-183,315 administered orally twice daily, alternating with twice daily oral administration of placebo tablets, for 10 days
900719|NCT01085539|B1|Baseline|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
900720|NCT01085539|P1|Participant Flow|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
900721|NCT01085539|O1|Outcome|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
900722|NCT01085539|E1|Reported Event|Infants With Oxygen Level Monitoring|In infants monitored for oxygen levels, the number of alarms that resulted in clinicians responding with an intervention that changed their care.
900723|NCT01085513|B3|Baseline|Total|Total of all reporting groups
900724|NCT01085513|B2|Baseline|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
900725|NCT01085513|B1|Baseline|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
900726|NCT01085513|P2|Participant Flow|Healthy Volunteers|Healthy volunteers
900727|NCT01085513|P1|Participant Flow|Patients|Patients previously indicated for manometry
900728|NCT01085513|O2|Outcome|Patients|"Patients previously indicated for manometry~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
900729|NCT01085513|O1|Outcome|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
900730|NCT01085513|E2|Reported Event|Healthy Volunteers|"Healthy volunteers~PillCam SB2: The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body."
900731|NCT01085513|E1|Reported Event|Patients|"Patients previously indicated for manometry~Two Moderate adverse events not related to studies procedure were reported within this study: abdominal pain and nausea.~In one case (i.e., abdominal pain) emergency visit occurred and the adverse events was resolved within four days."
900732|NCT01085500|B3|Baseline|Total|Total of all reporting groups
900733|NCT01085500|B2|Baseline|Current Practice|General surgery residents will undergo training according to current practice.
900734|NCT01085500|B1|Baseline|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
900735|NCT01085500|P2|Participant Flow|Current Practice|General surgery residents will undergo training according to current practice.
900736|NCT01085500|P1|Participant Flow|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
900737|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
900738|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
900739|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
900740|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
900741|NCT01085500|O2|Outcome|Current Practice|General surgery residents will undergo training according to current practice.
900742|NCT01085500|O1|Outcome|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
900743|NCT01085500|E2|Reported Event|Current Practice|General surgery residents will undergo training according to current practice.
900744|NCT01085500|E1|Reported Event|Simulation Curriculum|General surgery residents will undergo a simulation-based educational curriculum on totally extraperitoneal (TEP) hernia repair.
900745|NCT01085357|B3|Baseline|Total|Total of all reporting groups
900746|NCT01085357|B2|Baseline|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
900747|NCT01085357|B1|Baseline|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
900748|NCT01085357|P2|Participant Flow|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
900749|NCT01085357|P1|Participant Flow|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
900750|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
900908|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900751|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
900752|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
900753|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
900754|NCT01085357|O2|Outcome|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
900755|NCT01085357|O1|Outcome|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
900756|NCT01085357|E2|Reported Event|Cataract Surgery Only|Subjects did not receive the CyPass Micro-Stent at the conclusion of their cataract surgery
900757|NCT01085357|E1|Reported Event|CyPass Micro-Stent + Cataract Surgery|Subjects received the CyPass Micro-Stent at the conclusion of their cataract surgery
900758|NCT01085331|B3|Baseline|Total|Total of all reporting groups
900759|NCT01085331|B2|Baseline|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900760|NCT01085331|B1|Baseline|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900761|NCT01085331|P2|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; Irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900762|NCT01085331|P1|Participant Flow|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 milligrams per day (mg/day) once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2.) at conventional doses on days 1 and 15 of the same 28 day cycle.
900763|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900764|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900765|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900766|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900767|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo+FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900768|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900825|NCT01085201|P4|Participant Flow|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900830|NCT01085201|O4|Outcome|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
911814|NCT01055704|O4|Outcome|Placebo|
900769|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900770|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900771|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900772|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900773|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900774|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900775|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900776|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900777|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900778|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900779|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900780|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900826|NCT01085201|P3|Participant Flow|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900827|NCT01085201|P2|Participant Flow|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900781|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900782|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900783|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900784|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900785|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900786|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900787|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900788|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900789|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900790|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900791|NCT01085331|O2|Outcome|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900792|NCT01085331|O1|Outcome|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900828|NCT01085201|P1|Participant Flow|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900829|NCT01085201|O5|Outcome|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900793|NCT01085331|O2|Outcome|Part 2 or Phase 2 Randomized Part: Placebo +FOLFIRI|Placebo was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900794|NCT01085331|O1|Outcome|Part 2 or Phase 2 Randomized Part: Pimasertib+FOLFIRI|Pimasertib was to be administered orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900795|NCT01085331|O1|Outcome|Pimasertib+FOLFIRI (Overall)|Pimasertib was administered orally once daily 45 mg/day and 60 mg/day on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a Bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900796|NCT01085331|E2|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 60 mg +FOLFIRI|Pimasertib was administered orally at a dose of 60 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900797|NCT01085331|E1|Reported Event|Part 1 or Safety Run-in Part: Pimasertib 45 mg +FOLFIRI|Pimasertib was administered orally at a dose of 45 mg/day once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle along with FOLFIRI (laevoleucovorin 200 mg/m^2 i.v infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 mL dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
900798|NCT01085318|B3|Baseline|Total|Total of all reporting groups
900799|NCT01085318|B2|Baseline|Arm 2 Healthy Control|Healthy Control
900800|NCT01085318|B1|Baseline|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
900801|NCT01085318|P2|Participant Flow|Arm 2 Healthy Control|Healthy Control
900802|NCT01085318|P1|Participant Flow|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
900803|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
900804|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
900805|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
900806|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
900807|NCT01085318|O2|Outcome|Arm 2 Healthy Control|Healthy Control
900808|NCT01085318|O1|Outcome|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
900809|NCT01085318|E2|Reported Event|Arm 2 Healthy Control|Healthy Control
900810|NCT01085318|E1|Reported Event|Arm 1 RRMS Patients|Rebif 44 mcg sc tiw
900811|NCT01085214|B1|Baseline|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
900812|NCT01085214|P1|Participant Flow|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
900813|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
900814|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
900815|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
900816|NCT01085214|O1|Outcome|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
900817|NCT01085214|E1|Reported Event|AZD6244 (Selumetinib) Treatment|Participants received AZD6244 (Selumetinib) orally (PO) twice a day (BID) on days 1-28. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity.
900818|NCT01085201|B6|Baseline|Total|Total of all reporting groups
900819|NCT01085201|B5|Baseline|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900820|NCT01085201|B4|Baseline|Stage 3|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900821|NCT01085201|B3|Baseline|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900822|NCT01085201|B2|Baseline|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900823|NCT01085201|B1|Baseline|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900824|NCT01085201|P5|Participant Flow|Stage 4|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900904|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900831|NCT01085201|O3|Outcome|Stage 2B|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900832|NCT01085201|O2|Outcome|Stage 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900833|NCT01085201|O1|Outcome|Stage 1|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900834|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900835|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900836|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900837|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900838|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900839|NCT01085201|O5|Outcome|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900840|NCT01085201|O4|Outcome|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900841|NCT01085201|O3|Outcome|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900842|NCT01085201|O2|Outcome|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900843|NCT01085201|O1|Outcome|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900844|NCT01085201|E5|Reported Event|Stage 4 - Dose Level 2|"24-hour infusion to children with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900845|NCT01085201|E4|Reported Event|Stage 3 - Dose Level 2|"24-hour infusion to adults with SCD who are having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900846|NCT01085201|E3|Reported Event|Stage 2B - Dose Level 2|"48-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AFTER STUDYING 3 PATIENTS BY AGREEMENT FROM THE FDA, IRB, AND DSMB. THIS STAGE IS CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900847|NCT01085201|E2|Reported Event|Stage 2 - Dose Level 2|"24-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900848|NCT01085201|E1|Reported Event|Stage 1 - Dose Levels 0, 1 and 2|"12-hour infusion to adults with SCD who are not having a pain crisis. THIS STAGE IS COMPLETE AND CLOSED TO ACCRUAL.~Lexiscan : Given as an infusion"
900849|NCT01085136|B1|Baseline|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
900850|NCT01085136|P3|Participant Flow|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900851|NCT01085136|P2|Participant Flow|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900852|NCT01085136|P1|Participant Flow|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
900853|NCT01085136|O3|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900854|NCT01085136|O2|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900855|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
900856|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900905|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900906|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900907|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900857|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900858|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
900859|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900860|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900861|NCT01085136|O1|Outcome|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
900862|NCT01085136|O2|Outcome|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900863|NCT01085136|O1|Outcome|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900864|NCT01085136|E3|Reported Event|Investigators Choice of Chemotherapy (Part B)|Reference therapy for Part B dose: Depending on schedule Intravenous or oral administration (2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900865|NCT01085136|E2|Reported Event|Afatinib Plus Paclitaxel (Part B)|Afatinib 40 mg film-coated tablet dose was orally administered once daily of each 28-day treatment course, with dose reductions to 30 mg/day and 20 mg/day (following the protocol defined dose reduction scheme) plus paclitaxel 80 mg/m2 administered via intravenous infusion once weekly (7 weeks on/1 week off; 2 dose reductions were allowed following the protocol defined dose reduction scheme and the current local summary of product characteristics).
900866|NCT01085136|E1|Reported Event|Afatinib Monotherapy (Part A)|Afatinib 50 mg film-coated tablet was orally administered once daily of each 28-day treatment course, with dose reductions to 40 mg/day and 30 mg/day (following the protocol-defined dose reduction scheme).
900867|NCT01085045|B1|Baseline|All Subjects|All Baseline Subjects
900868|NCT01085045|P1|Participant Flow|Overall Study|Sentinel patients were the first 4 patients enrolled to receive one week of treatment with either GFF MDI 72/9.6mcg, GFF MDI 36/9.6 mcg, GP MDI 36 mcg or FF MDI 9.6 mcg because this was the first time GFF MDI was administered to patients with COPD, the sentinel patients provided additional assurance of safety.9.6
900869|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900870|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900871|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900872|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900873|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900874|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900875|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900876|NCT01085045|O6|Outcome|Foradil 12 μg|Foradil 12 μg
900877|NCT01085045|O5|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900878|NCT01085045|O4|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900879|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900880|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900881|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900882|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900883|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900884|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900885|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900886|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900887|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900888|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900889|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900890|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900891|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900892|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900893|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900894|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900895|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900896|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900897|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900898|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900899|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900900|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900901|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900902|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900903|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900915|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900916|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900917|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900918|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900919|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900920|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900921|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900922|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900923|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900924|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900925|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900926|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900927|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900928|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900929|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900930|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900931|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900932|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900933|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900934|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900935|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900936|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900937|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900938|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900939|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900940|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900941|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900942|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900943|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900944|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900945|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900946|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900947|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900948|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900949|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900950|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900951|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900952|NCT01085045|O7|Outcome|Foradil 12 μg|Foradil 12 μg
900953|NCT01085045|O6|Outcome|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900954|NCT01085045|O5|Outcome|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900955|NCT01085045|O4|Outcome|Spiriva 18 μg|Spiriva 18 μg
900956|NCT01085045|O3|Outcome|GP MDI 36 μg|GP MDI 36 μg (PT001)
900957|NCT01085045|O2|Outcome|GFF MDI 36/9.6 μg|GFF MDI 36/9.6 μg (PT003)
900958|NCT01085045|O1|Outcome|GFF MDI 72/9.6 μg|GFF MDI 72/9.6 μg (PT003)
900959|NCT01085045|E8|Reported Event|Foradil Aerolizer|Foradil Aerolizer 12 μg
900960|NCT01085045|E7|Reported Event|Placebo|Placebo MDI
900961|NCT01085045|E6|Reported Event|FF MDI 7.2 μg|FF MDI 7.2 μg (PT005)
900962|NCT01085045|E5|Reported Event|FF MDI 9.6 μg|FF MDI 9.6 μg (PT005)
900963|NCT01085045|E4|Reported Event|Spiriva|Handihaler 18 μg
900964|NCT01085045|E3|Reported Event|GP MDI 36 μg|GP MDI 36 μg (PT001)
900965|NCT01085045|E2|Reported Event|GP/FF MDI 36/9.6 μg|GP/FF MDI 36/9.6 μg (PT003)
900966|NCT01085045|E1|Reported Event|GP/FF MDI 72/9.6 μg|GP/FF MDI 72/9.6 μg (PT003)
900967|NCT01085006|B3|Baseline|Total|Total of all reporting groups
900968|NCT01085006|B2|Baseline|Normal Saline Infusion|
900969|NCT01085006|B1|Baseline|Tranexamic Acid|
900970|NCT01085006|P2|Participant Flow|Normal Saline Infusion|
900971|NCT01085006|P1|Participant Flow|Tranexamic Acid|
900972|NCT01085006|O2|Outcome|Normal Saline Infusion|
900973|NCT01085006|O1|Outcome|Tranexamic Acid|
900974|NCT01085006|E2|Reported Event|Normal Saline Infusion|
900975|NCT01085006|E1|Reported Event|Tranexamic Acid|
900976|NCT01084759|B1|Baseline|Etoposide and Testosterone|Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days.
900977|NCT01084759|P1|Participant Flow|Testosterone|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
900978|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
900979|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
900980|NCT01084759|O1|Outcome|Treatment Group|Testosterone cypionate 400 mg intramuscular, day 1 of 28; etoposide 100 mg oral daily, days 1-14 of 28. Note: Etoposide is only given for 3, 28-day cycles.
900981|NCT01084759|E1|Reported Event|Treatment Group|Men with castration-resistant prostate cancer will continue on androgen ablative therapy with LHRH agonist (i.e. Zoladex or Lupron) if not surgically castrated. Patients will receive intramuscular injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy).
900982|NCT01084707|B1|Baseline|All Randomized Subjects|All subjects randomized into the trial, e.g., Full Analysis Set
900983|NCT01084707|P1|Participant Flow|Overall Study|All subjects randomized into the trial
900984|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
900985|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
900986|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
900987|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
900988|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
900989|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
900990|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
900991|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
900992|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
900993|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
900994|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
900995|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
900996|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
900997|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
900998|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
900999|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
901000|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
901001|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
901002|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
901003|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
901004|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
901005|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
901006|NCT01084707|O5|Outcome|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
901007|NCT01084707|O4|Outcome|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
901008|NCT01084707|O3|Outcome|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
901009|NCT01084707|O2|Outcome|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
901010|NCT01084707|O1|Outcome|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
901011|NCT01084707|E5|Reported Event|Nicorette® Gum 4 mg|12 doses of NICORETTE® gum 4 mg over 11 hours
901012|NCT01084707|E4|Reported Event|NiQuitin™ Lozenge 4 mg|NiQuitin™ lozenge 4 mg; 12 doses of NiQuitin™ lozenge 4 mg over 11 hours
901013|NCT01084707|E3|Reported Event|Oral Nicotine 48|Oral Nicotine 48 mg, 2 1mg administrations by study personnel once every 30 minutes; 24 doses of 2 mg over 11.5 hours
901014|NCT01084707|E2|Reported Event|Oral Nicotine 24|Oral Nicotine 24 mg, 2 1mg administrations by study personnel once every hour; 12 doses of 2 mg over 11 hours
901015|NCT01084707|E1|Reported Event|Oral Nicotine 24-SA|Oral Nicotine 24 mg, 2 1mg self-administrations once every hour; 12 doses of 2 mg over 11 hours
901016|NCT01084668|B1|Baseline|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
901017|NCT01084668|P1|Participant Flow|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
901018|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
901019|NCT01084668|O2|Outcome|Subgroup With Nail Psoriasis|Subgroup of participants with nail psoriasis and a NAPSI score greater than 0 for at least 1 study visit
901020|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
901021|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatoid drug (BDMARD) failure
901022|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
901023|NCT01084668|O1|Outcome|All Treated|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
901086|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901024|NCT01084668|E1|Reported Event|Adalimumab|Participants with moderate to severe chronic plaque psoriasis treated with adalimumab after biologic disease modifying anti-rheumatic drug (BDMARD) failure
901025|NCT01084603|B1|Baseline|Overall Study|Full Safety Set
901026|NCT01084603|P1|Participant Flow|Overall Study|Full Safety Set
901027|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
901028|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
901029|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
901030|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
901031|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
901032|NCT01084603|O1|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
901033|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
901034|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
901035|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
901036|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
901037|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
901038|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
901039|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
901040|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
901041|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
901042|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
901043|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
901044|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
901045|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
901046|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
901047|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
901048|NCT01084603|O5|Outcome|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
901049|NCT01084603|O4|Outcome|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
901050|NCT01084603|O3|Outcome|Oral Nicotine 4|4 administrations of 1 mg
901051|NCT01084603|O2|Outcome|Oral Nicotine 2|2 administrations of 1 mg
901052|NCT01084603|O1|Outcome|Oral Nicotine 1|1 administration of 1 mg
901053|NCT01084603|E5|Reported Event|Nicorette® Gum 4 mg|One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
901054|NCT01084603|E4|Reported Event|NiQuitinTM Lozenge 4 mg|1 NiQuitinTM nicotine lozenge 4 mg
901055|NCT01084603|E3|Reported Event|Oral Nicotine 4|4 administrations of 1 mg
901056|NCT01084603|E2|Reported Event|Oral Nicotine 2|2 administrations of 1 mg
901057|NCT01084603|E1|Reported Event|Oral Nicotine 1|1 administration of 1 mg
901058|NCT01084551|B4|Baseline|Total|Total of all reporting groups
901059|NCT01084551|B3|Baseline|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901060|NCT01084551|B2|Baseline|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901061|NCT01084551|B1|Baseline|Placebo|0 mg/day for 13 weeks
901062|NCT01084551|P3|Participant Flow|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901063|NCT01084551|P2|Participant Flow|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901064|NCT01084551|P1|Participant Flow|Placebo|0 mg/day for 13 weeks
901065|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901066|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901067|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901068|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901069|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901070|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901071|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901072|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901073|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901074|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901075|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901076|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901077|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901078|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901079|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901080|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901081|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901082|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901083|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901084|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901085|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901308|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901087|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901088|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901089|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
903789|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
901090|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901091|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901092|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901093|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901094|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901095|NCT01084551|O3|Outcome|SPM 962 6.75|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901096|NCT01084551|O2|Outcome|SPM 962 4.5|Once a daily transdermal administration of SPM 962 started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901097|NCT01084551|O1|Outcome|Placebo|Once a daily transdermal administration for 13 weeks
901098|NCT01084551|E3|Reported Event|SPM 962 6.75|started at 2.25 mg/day to 6.75 mg/day for 13 weeks
901099|NCT01084551|E2|Reported Event|SPM 962 4.5|started at 2.25 mg/day to 4.5 mg/day for 13 weeks
901100|NCT01084551|E1|Reported Event|Placebo|0 mg/day for 13 weeks
901101|NCT01084538|B1|Baseline|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
901102|NCT01084538|P1|Participant Flow|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
901103|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
901104|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
901105|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
901106|NCT01084538|O1|Outcome|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
901107|NCT01084538|E1|Reported Event|End Stage Chronic Kidney Disease|Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone [iPTH] less than 300 picograms per milliliter [pg/mL]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
901108|NCT01084278|B6|Baseline|Total|Total of all reporting groups
901109|NCT01084278|B5|Baseline|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901110|NCT01084278|B4|Baseline|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901111|NCT01084278|B3|Baseline|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901112|NCT01084278|B2|Baseline|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901113|NCT01084278|B1|Baseline|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901114|NCT01084278|P5|Participant Flow|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901115|NCT01084278|P4|Participant Flow|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901116|NCT01084278|P3|Participant Flow|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901117|NCT01084278|P2|Participant Flow|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901118|NCT01084278|P1|Participant Flow|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901163|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
911815|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
901119|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901120|NCT01084278|O1|Outcome|End Stage Renal Disease (ESRD)|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken under standard fasting conditions on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901121|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901122|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901123|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901124|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901125|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901126|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901127|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901128|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901129|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901130|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901131|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901132|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901133|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901134|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901135|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901136|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901137|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901138|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901139|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901140|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901141|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901142|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901143|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901144|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901145|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901146|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901147|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901148|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901149|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901150|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901151|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901152|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901153|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901154|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901155|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901156|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901157|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901158|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901159|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901160|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901161|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901162|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901164|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901165|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901166|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901167|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901168|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901169|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901170|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901171|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901172|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901173|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901174|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901175|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901176|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901177|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901178|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901179|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901180|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901181|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901182|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901183|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901184|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901185|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901186|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901187|NCT01084278|O6|Outcome|ESRD - on Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901188|NCT01084278|O5|Outcome|ESRD - Off Dialysis|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet taken on study day 1 immediately following dialysis.
901189|NCT01084278|O4|Outcome|Severe|Participants with severe renal impairment received one colchicine 0.6 mg tablet on study day 1.
901190|NCT01084278|O3|Outcome|Moderate|Participants with moderate renal impairment received one colchicine 0.6 mg tablet on study day 1.
901191|NCT01084278|O2|Outcome|Mild|Participants with mild renal impairment received one colchicine 0.6 mg tablet on study day 1.
901192|NCT01084278|O1|Outcome|Healthy|Healthy participants with normal renal function received one colchicine 0.6 mg tablet on study day 1.
901193|NCT01084278|E5|Reported Event|ESRD|Participants with end stage renal disease (ESRD) received one colchicine 0.6 mg tablet on study day 1 immediately following dialysis. After a 14-day washout, participants received one colchicine 0.6 mg tablet on Day 15 prior to dialysis.
901194|NCT01084278|E4|Reported Event|Severe|Participants with severe renal impairment (eGFR 15 to 29 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901195|NCT01084278|E3|Reported Event|Moderate|Participants with moderate renal impairment CrCl/eGFR 30 to 59 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901196|NCT01084278|E2|Reported Event|Mild|Participants with mild renal impairment (estimated Glomerular Filtration Rate [eGFR] 60 to 89 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901197|NCT01084278|E1|Reported Event|Healthy|Healthy participants with normal renal function (Creatinine Clearance [CrCl] ≥90 mL/min) received one colchicine 0.6 mg tablet on study day 1.
901198|NCT01084265|B1|Baseline|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901199|NCT01084265|P1|Participant Flow|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901200|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901201|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901245|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901311|NCT01083979|B1|Baseline|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
901202|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901203|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901204|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901205|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901206|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901207|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901208|NCT01084265|O1|Outcome|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901209|NCT01084265|E1|Reported Event|Recombinant Human Luteinizing Hormone (Luveris)|Recombinant human luteinizing hormone (rhLH, Luveris) injection 75 international units (IU) subcutaneously (s.c.) daily along with 150 IU recombinant human follicle-stimulating hormone (rhFSH, Gonal-F) s.c. daily for no longer than 14 days unless the diameter of ovarian follicles indicated the maturation (greater than 14 millimeter [mm]).
901210|NCT01084239|B3|Baseline|Total|Total of all reporting groups
901211|NCT01084239|B2|Baseline|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901212|NCT01084239|B1|Baseline|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901213|NCT01084239|P2|Participant Flow|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901214|NCT01084239|P1|Participant Flow|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901215|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901216|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901217|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901218|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901219|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901244|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901220|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901221|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901222|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901223|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901224|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901225|NCT01084239|O2|Outcome|Standard of Care|Subjects in this arm (50% of the total cohort) will continue to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901226|NCT01084239|O1|Outcome|Cardiac CT|"Subjects in this arm (50% of the total cohort) will be randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT will be performed in addition to standard evaluation. Reconstructed data sets will be evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901227|NCT01084239|E2|Reported Event|Standard of Care|Subjects in this arm (50% of the total cohort) continued to receive standard non-invasive evaluation of acute chest pain symptoms in the emergency department - mostly comprising of, but not limited to - exercise treadmill test, stress test with imaging and stress echocardiography.
901228|NCT01084239|E1|Reported Event|Cardiac CT|"Subjects in this arm (50% of the total cohort) were randomized to receive a cardiac computed tomography scan as part of the initial evaluation of acute chest pain symptoms, upon presentation to the emergency department.~Cardiac Computed Tomography : A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings."
901229|NCT01084174|B3|Baseline|Total|Total of all reporting groups
901230|NCT01084174|B2|Baseline|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901231|NCT01084174|B1|Baseline|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901232|NCT01084174|P2|Participant Flow|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901233|NCT01084174|P1|Participant Flow|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901234|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901235|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901236|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901237|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901238|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901239|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901240|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901241|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901242|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901243|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901305|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901246|NCT01084174|O2|Outcome|Active OIT/Placebo SLIT|"These subjects will receive peanut extract given sublingually and placebo powder given orally.~Peanut extract: Delivered sublingually~Placebo powder: Delivered orally"
901247|NCT01084174|O1|Outcome|Active SLIT/Placebo OIT|"These subjects will receive peanut powder given orally and placebo extract given sublingually.~Peanut powder: Delivered orally~Placebo extract: Delivered sublingually"
901248|NCT01084174|E2|Reported Event|Active OIT/Placebo SLIT|Adverse event information is based on percentages of doses. There were 4049 total doses in the Active OIT/Placebo SLIT treatment arm
901249|NCT01084174|E1|Reported Event|Active SLIT/Placebo OIT|Adverse event information is based on percentages of doses. There were 4578 total doses in the Active SLIT/Placebo OIT treatment arm
901250|NCT01084148|B3|Baseline|Total|Total of all reporting groups
901251|NCT01084148|B2|Baseline|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
901252|NCT01084148|B1|Baseline|V0034CR01B|"cream~V0034CR01B"
901253|NCT01084148|P2|Participant Flow|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
901254|NCT01084148|P1|Participant Flow|V0034CR01B|"cream~V0034CR01B"
901255|NCT01084148|O2|Outcome|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
901256|NCT01084148|O1|Outcome|V0034CR01B|"cream~V0034CR01B"
901257|NCT01084148|E2|Reported Event|V0034 CR 01B Vehicle|"cream~V0034CR01B vehicle"
901258|NCT01084148|E1|Reported Event|V0034CR01B|"cream~V0034CR01B"
901259|NCT01084135|B5|Baseline|Total|Total of all reporting groups
901260|NCT01084135|B4|Baseline|12 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
901261|NCT01084135|B3|Baseline|12 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
901262|NCT01084135|B2|Baseline|20 Week Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
901263|NCT01084135|B1|Baseline|20 Week Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
901264|NCT01084135|P2|Participant Flow|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
901265|NCT01084135|P1|Participant Flow|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
901266|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
901267|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
901268|NCT01084135|O2|Outcome|Liquid Placebo|"Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.~Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste."
901269|NCT01084135|O1|Outcome|Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
901270|NCT01084135|E4|Reported Event|12 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
901306|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901307|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
911816|NCT01055704|O2|Outcome|Codeine 30 mg|
901309|NCT01084005|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901310|NCT01084005|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
901271|NCT01084135|E3|Reported Event|12 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional four weeks. At the week 6 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 6 weeks.
901272|NCT01084135|E2|Reported Event|20 Week: Liquid Placebo|Liquid Placebo: Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
901273|NCT01084135|E1|Reported Event|20 Week: Rivastigmine- Liquid Form|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
901274|NCT01084083|B1|Baseline|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
901275|NCT01084083|P1|Participant Flow|Overall|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
901276|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
901277|NCT01084083|O1|Outcome|Eligible and Treated Patients|Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.
901278|NCT01084083|O1|Outcome|Primary Study Population|The primary study population for this endpoint is patients who were confirmed post-induction clinical complete response (CR) at their primary sites and subsequently received 5400 cGy radiation therapy to their primary sites.
901279|NCT01084083|E1|Reported Event|All Treated Patients|"Patients receive cisplatin IV on day 1 and paclitaxel IV and cetuximab IV on days 1, 8, and 15. Treatment repeats every 21 days for 3 courses. Patients then undergo evaluation of response to induction therapy. Patients with a CR at the primary tumor site proceed to group 1 of concurrent low-dose IMRT and cetuximab. Patients with a PR or SD at the primary tumor site or those with grossly positive disease at the primary tumor site proceed to group 2 of concurrent standard dose IMRT and cetuximab.~Adverse events data were reported for all patients received at least one dose of protocol therapy."
901280|NCT01084005|B3|Baseline|Total|Total of all reporting groups
901281|NCT01084005|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901282|NCT01084005|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
901283|NCT01084005|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901284|NCT01084005|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
901285|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901286|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901287|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901288|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901289|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901290|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901291|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901292|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901293|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901294|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901295|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901296|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901297|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901298|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901299|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901300|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901301|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901302|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901303|NCT01084005|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg
901304|NCT01084005|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
901312|NCT01083979|P1|Participant Flow|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
901313|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
901314|NCT01083979|O1|Outcome|Liposomes|Intravesical instillation of Liposomes in sterile water totalling 40 cc at four weekly treatments.
901315|NCT01083979|E1|Reported Event|Liposomes|Intravesical instillation of Liposomes in sterile water totally 40 cc at four weekly treatments.
901316|NCT01083901|B4|Baseline|Total|Total of all reporting groups
901317|NCT01083901|B3|Baseline|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
901318|NCT01083901|B2|Baseline|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
901319|NCT01083901|B1|Baseline|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
901320|NCT01083901|P3|Participant Flow|Placebo and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and placebo pills (matching active study drug) taken 2 hours before exercise on exercise days for up to 36 weeks.
901321|NCT01083901|P2|Participant Flow|Ibuprofen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 400 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
901322|NCT01083901|P1|Participant Flow|Acetaminophen and Resistance Exercise|Progressive resistance exercise training and bone-loading exercise on up to 6 days per week and administration of acetaminophen, 1000 mg, taken 2 hours before exercise on exercise days for up to 36 weeks.
901323|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
901324|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
901325|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
901326|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
901327|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
901328|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
901329|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
901330|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
901331|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
901332|NCT01083901|O3|Outcome|Placebo and Resistance Exercise Training|
901333|NCT01083901|O2|Outcome|Ibuprofen and Resistance Exercise Training|
901334|NCT01083901|O1|Outcome|Acetaminophen and Resistance Exercise Training|
901335|NCT01083901|E3|Reported Event|Placebo and Resistance Exercise Training|
901336|NCT01083901|E2|Reported Event|Ibuprofen and Resistance Exercise Traininig|
901337|NCT01083901|E1|Reported Event|Acetaminophen and Resistance Exercise Training|
901338|NCT01083849|B3|Baseline|Total|Total of all reporting groups
901339|NCT01083849|B2|Baseline|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901340|NCT01083849|B1|Baseline|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901341|NCT01083849|P2|Participant Flow|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901342|NCT01083849|P1|Participant Flow|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901343|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901344|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901345|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901346|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901347|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901348|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901349|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
917353|NCT01037218|O4|Outcome|Placebo|Placebo tablets
901350|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901351|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901352|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901353|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901354|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901355|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901356|NCT01083849|O2|Outcome|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
901357|NCT01083849|O1|Outcome|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, prescribed on an on-label basis in an everyday setting. Participants were observed for 12 months.
901358|NCT01083849|O1|Outcome|Paricalcitol|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, not treated with paricalcitol for at least 6 months prior inclusion in this study, received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901359|NCT01083849|E2|Reported Event|Paricalcitol Dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901360|NCT01083849|E1|Reported Event|Paricalcitol Pre-dialysis Group|Participants with chronic kidney disease and a diagnosis of secondary hyperparathyroidism, and who were not yet on dialysis received paricalcitol injection or capsules, on an on-label basis in an everyday setting. Participants were observed for 12 months.
901361|NCT01083810|B4|Baseline|Total|Total of all reporting groups
901362|NCT01083810|B3|Baseline|Non-B|Participants infected with non-B subtypes of HIV-1.
901363|NCT01083810|B2|Baseline|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901364|NCT01083810|B1|Baseline|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901365|NCT01083810|P3|Participant Flow|Non-B|Participants infected with non-B subtypes of HIV-1.
901366|NCT01083810|P2|Participant Flow|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901367|NCT01083810|P1|Participant Flow|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901368|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
901369|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901370|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901371|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
901372|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901373|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901374|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
901375|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901376|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901377|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
901378|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901379|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901380|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
901381|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901382|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901383|NCT01083810|O3|Outcome|Non-B|Participants infected with non-B subtypes of HIV-1.
901384|NCT01083810|O2|Outcome|Pre-treated|Participants that had previously received antiretroviral therapy, but were protease inhibitor naive.
901385|NCT01083810|O1|Outcome|Therapy-naive|Participants who had not received prior antiretroviral drug therapy.
901386|NCT01083810|E1|Reported Event|HIV-infected Patients|Participants with HIV-1 infection, pooled from 3 studies in different populations conducted in parallel: KAL1RO (therapy-naive, NCT01083810, n=137), KAL2RO /KAL5RO (pre-treated, NCT01083836, n=92), and KAL6RO (non-B subtype, NCT01081470, n=55).
911817|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
901387|NCT01083771|B1|Baseline|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
901388|NCT01083771|P1|Participant Flow|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
901389|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
901390|NCT01083771|O1|Outcome|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
901391|NCT01083771|E1|Reported Event|Olive Oil|"At least 3 tablespoons of olive oil each day~Olive Oil: Minimum of 3 tablespoon of olive oil per day"
901392|NCT01083758|B1|Baseline|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901393|NCT01083758|P1|Participant Flow|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901394|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901395|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901396|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901397|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901398|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901399|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901400|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901401|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901402|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901403|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901404|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901405|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901406|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901407|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901408|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901409|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901410|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901411|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901412|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901413|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901414|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901415|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901513|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901416|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901417|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901418|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901419|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901420|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901421|NCT01083758|O1|Outcome|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901422|NCT01083758|E1|Reported Event|LEO 80185 Gel|Taclonex® Scalp Topical Suspension/Daivobet® gel /Dovobet® gel/Xamiol® gel Calcipotriol 50 mcg/g plus betamethasone 0.5 mg/g (as dipropionate) gel once daily for up to 8 week to treat psoriasis on the scalp
901423|NCT01083732|B4|Baseline|Total|Total of all reporting groups
901424|NCT01083732|B3|Baseline|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901425|NCT01083732|B2|Baseline|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901426|NCT01083732|B1|Baseline|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901427|NCT01083732|P3|Participant Flow|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901428|NCT01083732|P2|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901429|NCT01083732|P1|Participant Flow|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901430|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901431|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901432|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901433|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901434|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901435|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901436|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901437|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901438|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901514|NCT01083693|O4|Outcome|Total|
901516|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901439|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901440|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901441|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901442|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901443|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901444|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901445|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901446|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901447|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901448|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901449|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901450|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901451|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901452|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901453|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901454|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation).
901455|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901456|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901457|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901458|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901515|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
911818|NCT01055704|O4|Outcome|Placebo|
901459|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901460|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901461|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901462|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901463|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901464|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901465|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901466|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901467|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901468|NCT01083732|O2|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901469|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)|The patients aged 1 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901470|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901471|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901472|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901473|NCT01083732|O3|Outcome|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901474|NCT01083732|O2|Outcome|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901475|NCT01083732|O1|Outcome|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901476|NCT01083732|E3|Reported Event|Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901477|NCT01083732|E2|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)|The patients aged 2 to <12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901478|NCT01083732|E1|Reported Event|Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)|The patients aged 1 to <2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)
901603|NCT01083472|B1|Baseline|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
901479|NCT01083706|B1|Baseline|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
901480|NCT01083706|P1|Participant Flow|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
901481|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
901482|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
901483|NCT01083706|O1|Outcome|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
901484|NCT01083706|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive azacitidine SC or IV on days 1-7. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.~azacitidine: Given SC or IV~laboratory biomarker analysis: Correlative studies"
901485|NCT01083693|B4|Baseline|Total|Total of all reporting groups
901486|NCT01083693|B3|Baseline|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
901487|NCT01083693|B2|Baseline|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901488|NCT01083693|B1|Baseline|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901489|NCT01083693|P3|Participant Flow|Ankylosing Spondylitis (AS)|Ankylosing Spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
901490|NCT01083693|P2|Participant Flow|Psoriasis Arthritis (PsA)|Psoriatic Arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901491|NCT01083693|P1|Participant Flow|Rheumatoid Arthritis (RA)|Rheumatoid Arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901492|NCT01083693|O4|Outcome|Total|
901493|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
901494|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901495|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901496|NCT01083693|O4|Outcome|Total|
901497|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
901498|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901499|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901500|NCT01083693|O3|Outcome|Total|
901501|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901502|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901503|NCT01083693|O3|Outcome|Total|
901504|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901505|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901506|NCT01083693|O1|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
901507|NCT01083693|O3|Outcome|Total|
901508|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901509|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901510|NCT01083693|O4|Outcome|Total|
901511|NCT01083693|O3|Outcome|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
901512|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901695|NCT01083121|E1|Reported Event|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901517|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901518|NCT01083693|O3|Outcome|Total|
901519|NCT01083693|O2|Outcome|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901520|NCT01083693|O1|Outcome|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901521|NCT01083693|E4|Reported Event|Total|
901522|NCT01083693|E3|Reported Event|Ankylosing Spondylitis (AS)|Ankylosing spondylitis participants with unsustainable clinical response to nonsteroidal antiinflammatory drugs and or biological disease modifying antirheumatic drugs.
901523|NCT01083693|E2|Reported Event|Psoriasis Arthritis (PsA)|Psoriatic arthritic participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901524|NCT01083693|E1|Reported Event|Rheumatoid Arthritis (RA)|Rheumatoid arthritis participants with unsustainable clinical response to disease modifying antirheumatic drugs and or biological disease modifying antirheumatic drugs.
901525|NCT01083680|B1|Baseline|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901526|NCT01083680|P1|Participant Flow|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901527|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901528|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901529|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901530|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901531|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901532|NCT01083680|O1|Outcome|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901533|NCT01083680|E1|Reported Event|Participants With Crohn's Disease (CD)|Participants with Crohn's Disease treated with adalimumab in routine clinical practice.
901534|NCT01083654|B3|Baseline|Total|Total of all reporting groups
901535|NCT01083654|B2|Baseline|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)"
901536|NCT01083654|B1|Baseline|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~ST Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by an enrolled member of the Menominee Tribe but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling."
901537|NCT01083654|P2|Participant Flow|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
901538|NCT01083654|P1|Participant Flow|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
901696|NCT01082965|B3|Baseline|Total|Total of all reporting groups
901563|NCT01083576|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
901539|NCT01083654|O2|Outcome|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
901540|NCT01083654|O1|Outcome|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
901541|NCT01083654|E2|Reported Event|Culturally-Tailored Treatment|"The Culturally-Tailored Treatment will consist of 12 weeks of open-label varenicline and culturally-tailored (for American Indians) smoking cessation counseling consisting of four sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Culturally-Tailored Treatment: The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol"
901542|NCT01083654|E1|Reported Event|Standard Treatment Counseling|"Standard Treatment (ST) will consist of 12 weeks of open-label varenicline and smoking cessation counseling consisting of 4 sessions: one in-person pre-quit counseling session during Study Visit 2, counseling during a phone call on the day after the quit day, and two additional in-person counseling sessions at Study Visits 3 and 4 (one week and three weeks after the quit day, respectively).~Standard Treatment Counseling: Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other w"
901543|NCT01083641|B1|Baseline|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
901544|NCT01083641|P1|Participant Flow|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
901545|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
901546|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
901547|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
901548|NCT01083641|O1|Outcome|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
901549|NCT01083641|E1|Reported Event|Estrogen Therapy|"Estrogen therapy~Estradiol: 10mg oral three times daily"
901550|NCT01083602|B1|Baseline|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901551|NCT01083602|P1|Participant Flow|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901552|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901553|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901554|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901555|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901556|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901557|NCT01083602|O1|Outcome|Panobinostat + Bortezomib & Dexamethasone|panobinostat in combination with bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma
901558|NCT01083602|E1|Reported Event|PAN + BTZ + Dex|PAN + BTZ + Dex
901559|NCT01083576|B3|Baseline|Total|Total of all reporting groups
901560|NCT01083576|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901561|NCT01083576|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901562|NCT01083576|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
902283|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
901564|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901565|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
901566|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901567|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
901568|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901569|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901570|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901571|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901572|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901573|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901574|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901575|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901576|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901577|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901578|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901579|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901580|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901581|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated cutaneous leishmaniasis (CL) lesions once daily for 20 days
901582|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901583|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901584|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901585|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901586|NCT01083576|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901587|NCT01083576|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901588|NCT01083576|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901589|NCT01083576|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to uncomplicated CL lesions once daily for 20 days
901590|NCT01083485|B3|Baseline|Total|Total of all reporting groups
901591|NCT01083485|B2|Baseline|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901592|NCT01083485|B1|Baseline|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901593|NCT01083485|P2|Participant Flow|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901594|NCT01083485|P1|Participant Flow|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901595|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901596|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901597|NCT01083485|O2|Outcome|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.1
901598|NCT01083485|O1|Outcome|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses). Mean baseline pain score = 3.4
901599|NCT01083485|E2|Reported Event|OXY Tablets|Oxycodone prolonged release (PR) 20mg or 10mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901600|NCT01083485|E1|Reported Event|OXN Tablets|Oxycodone/Naloxone prolonged release (PR) 20/10mg or 10/5mg tablets twice a day (BID) for 2.5 days (total = 5 doses)
901601|NCT01083472|B3|Baseline|Total|Total of all reporting groups
901602|NCT01083472|B2|Baseline|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
901604|NCT01083472|P2|Participant Flow|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
901605|NCT01083472|P1|Participant Flow|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
901606|NCT01083472|O2|Outcome|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
901607|NCT01083472|O1|Outcome|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
901608|NCT01083472|E2|Reported Event|Standard of Care Repair|Abdominal wall defect will be repaired using current standard of care techniques of either suture alone or suture with absorbable surgical mesh
901609|NCT01083472|E1|Reported Event|Strattice(TM) TM Repair|Strattice(TM) TM will be placed in the intraperitoneal or retrorectus position to support the repair of abdominal wall defect
901610|NCT01083316|B1|Baseline|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose intravenous (IV) Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
901611|NCT01083316|P1|Participant Flow|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
901612|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
901613|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
901614|NCT01083316|O1|Outcome|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
901615|NCT01083316|E1|Reported Event|Bortezomib and Dexamethasone|"Induction:~Bortezomib (Velcade) 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4 Melphalan 70-100 mg/m2/day IV on days -2 and -1~Bortezomib (Velcade) and Dexamethasone: Induction:~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days~Conditioning:~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
901616|NCT01083199|B1|Baseline|AMS CONTINUUM™ Device|
901617|NCT01083199|P1|Participant Flow|AMS CONTINUUM™ Device|
901618|NCT01083199|O1|Outcome|AMS CONTINUUM™ Device|
901619|NCT01083199|O1|Outcome|Continuum Device|
901620|NCT01083199|E1|Reported Event|AMS CONTINUUM™ Device|
901621|NCT01083186|B1|Baseline|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901622|NCT01083186|P1|Participant Flow|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901623|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901624|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901625|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901626|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901697|NCT01082965|B2|Baseline|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901699|NCT01082965|P2|Participant Flow|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901627|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901628|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901629|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901630|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901631|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901632|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901633|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901634|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901635|NCT01083186|O4|Outcome|CKD Stage 5|Participants with chronic kidney disease stage 5 (eGFR <15 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901636|NCT01083186|O3|Outcome|CKD Stage 4|Participants with chronic kidney disease stage 4 (eGFR 15-29 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901637|NCT01083186|O2|Outcome|CKD Stage 3|Participants with chronic kidney disease stage 3 (eGFR 30-59 mL/min/1.73m^2)with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901638|NCT01083186|O1|Outcome|CKD Stage 2|Participants with chronic kidney disease stage 2 (eGFR 60-89 mL/min/1.73m^2) with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901639|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901640|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901641|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 12"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
901642|NCT01083186|O4|Outcome|"++ Albuminuria at Month 12"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
901643|NCT01083186|O3|Outcome|"+ Albuminuria at Month 12"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
901644|NCT01083186|O2|Outcome|Trace Albuminuria at Month 12|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
901645|NCT01083186|O1|Outcome|No Albuminuria at Month 12|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
901646|NCT01083186|O5|Outcome|"+++ Albuminuria at Month 6"|"The value +++ is taken directly from the dipstick measurements, and represents the highest albuminuria."
901647|NCT01083186|O4|Outcome|"++ Albuminuria at Month 6"|"The value ++ is taken directly from the dipstick measurements, and represents the value second to highest albuminuria."
901648|NCT01083186|O3|Outcome|"+ Albuminuria at Month 6"|"The value + is taken directly from the dipstick measurements, and represents the middle of a range from none to highest albuminuria."
901649|NCT01083186|O2|Outcome|Trace Albuminuria at Month 6|"The value Trace is taken directly from the dipstick measurements, and represents a reading of trace albuminuria."
901650|NCT01083186|O1|Outcome|No Albuminuria at Month 6|"The value - is taken directly from the dipstick measurements, and represents a reading of no albuminuria."
901651|NCT01083186|O2|Outcome|Participants Outside of the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
901652|NCT01083186|O1|Outcome|Participants Within the Phosphorus Normal Range|Normal serum phosphorus range was 2.7-4.6 mg/dL.
901653|NCT01083186|O2|Outcome|Participants Outside of the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
901654|NCT01083186|O1|Outcome|Participants Within the Normal Calcium Range|Normal serum calcium range was 8.4-10.2 mg/dL.
901655|NCT01083186|O2|Outcome|Participants Out of the iPTH Target Range|Number of participants with iPTH levels outside of the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
901656|NCT01083186|O1|Outcome|Participants Within the iPTH Target Range|Number of participants with iPTH levels within the target range of K/DOQI treatment guidelines: CKD Stage 3: 35-70 pg/mL; CKD Stage 4: 70-110 pg/mL during a 12-month period of treatment with oral paricalcitol.
901657|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901698|NCT01082965|B1|Baseline|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901658|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901659|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901660|NCT01083186|O1|Outcome|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901661|NCT01083186|E1|Reported Event|Chronic Kidney Disease (CKD), Secondary Hyperpathyroidism|Participants with chronic kidney disease stage 3-5 with secondary hyperparathyroidism, who were prescribed oral paricalcitol according to the approved Summary of Product Characteristics (SmPC)
901662|NCT01083173|B1|Baseline|Overall Study|The main surveillance safety population included all participants who received at least one dose of Kaletra. The long-term surveillance safety population included participants who received Kaletra for more than 24 weeks.
901663|NCT01083173|P2|Participant Flow|Long-term Surveillance|The safety population included all participants who received Kaletra for more than 24 weeks, and the effectiveness population included all participants who received Kaletra treatment for at least 48 weeks.
901664|NCT01083173|P1|Participant Flow|Main Surveillance|The safety population included all participants who received at least one dose of Kaletra, and the effectiveness population included all participants who received Kaletra treatment for at least 24 weeks.
901665|NCT01083173|O1|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
901666|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
901667|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
901668|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
901669|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
901670|NCT01083173|O2|Outcome|Long-term Surveillance|All participants who received Kaletra treatment for at least 48 weeks
901671|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
901672|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
901673|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
901674|NCT01083173|O1|Outcome|Main Surveillance|All participants who received Kaletra treatment for at least 24 weeks
901675|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
901676|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
901677|NCT01083173|O2|Outcome|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
901678|NCT01083173|O1|Outcome|Main Surveillance|All participants who received at least one dose of Kaletra
901679|NCT01083173|E2|Reported Event|Long-term Surveillance|Participants who received Kaletra for more than 24 weeks
901680|NCT01083173|E1|Reported Event|Main Surveillance|All participants who received at least one dose of Kaletra
901681|NCT01083160|B1|Baseline|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
901682|NCT01083160|P1|Participant Flow|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
901683|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
901684|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
901685|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
901686|NCT01083160|O1|Outcome|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
901687|NCT01083160|E1|Reported Event|Non Responders to Other Anti-TNF|Patients with lack of efficacy to infliximab or etanercept treated with adalimumab according to the routine clinical practice of the participating centers. A 40 mg dose was administered every other week for 24 weeks.
901688|NCT01083121|B1|Baseline|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901689|NCT01083121|P1|Participant Flow|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901690|NCT01083121|O4|Outcome|Crohn's Disease|Participants with severely active Crohn's disease who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901691|NCT01083121|O3|Outcome|Ankylosing Spondylitis|Participants with severe active ankylosing spondylitis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901692|NCT01083121|O2|Outcome|Psoriatic Arthritis|Participants with active and progressive psoriatic arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901693|NCT01083121|O1|Outcome|Rheumatoid Arthritis|Participants with moderately to severely active rheumatoid arthritis who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901694|NCT01083121|O1|Outcome|Adalimumab|Participants who were prescribed with adalimumab per approved prescribing information of adalimumab in Korea.
901700|NCT01082965|P1|Participant Flow|Donepezil|Donepezil 5 milligram (mg) tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901701|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901702|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901703|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901704|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901705|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901706|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901707|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901708|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901709|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901710|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901711|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901712|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901713|NCT01082965|O2|Outcome|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901714|NCT01082965|O1|Outcome|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901715|NCT01082965|E2|Reported Event|Placebo|Placebo matched to donepezil 5 mg tablet orally once daily up to Day 7, followed by placebo matched to donepezil 10 mg tablet orally once on Day 8.
901716|NCT01082965|E1|Reported Event|Donepezil|Donepezil 5 mg tablet orally once daily up to Day 7, followed by donepezil 10 mg tablet orally once on Day 8.
901717|NCT01082952|B3|Baseline|Total|Total of all reporting groups
901718|NCT01082952|B2|Baseline|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
901719|NCT01082952|B1|Baseline|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
901720|NCT01082952|P2|Participant Flow|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
901721|NCT01082952|P1|Participant Flow|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
901722|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
901723|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
901724|NCT01082952|O2|Outcome|Non Asthmatic Patients|Non asthmatic patients with high Eosinophil count (>3%)
901725|NCT01082952|O1|Outcome|Asthmatic Patients|Mild asthmatic patients with high eosinophil count (>5%)
901726|NCT01082952|E2|Reported Event|Non Asthmatic Patients|Non asthmatic patients with high eosinophil count (>3%).
901727|NCT01082952|E1|Reported Event|Asthmatic Patients|Patients were severe asthmatic with high peripheral blood eosinophil counts (>5%).
901728|NCT01082939|B1|Baseline|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
901729|NCT01082939|P1|Participant Flow|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
901730|NCT01082939|O1|Outcome|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
901731|NCT01082939|E1|Reported Event|CFAR|CFAR: Cyclophosphamide 250 mg/m^2/day intravenous (IV) Days 3-5, Fludarabine 25 mg/m^2/day IV Days 3-5, Alemtuzumab 30 mg IV Days 1, 3 and 5 over 2-4 hours, repeated every four weeks for a total of 6 planned cycles, and Rituximab Cycle 1 (Week 1): 375 mg/m^2/day IV Day 2 over 4- 6 hours, Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV Day 2 over 4- 6 hours.
901732|NCT01082874|B5|Baseline|Total|Total of all reporting groups
901733|NCT01082874|B4|Baseline|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901734|NCT01082874|B3|Baseline|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901754|NCT01082640|P2|Participant Flow|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901755|NCT01082640|P1|Participant Flow|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
917354|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
901735|NCT01082874|B2|Baseline|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901736|NCT01082874|B1|Baseline|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901737|NCT01082874|P4|Participant Flow|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901738|NCT01082874|P3|Participant Flow|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901739|NCT01082874|P2|Participant Flow|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901740|NCT01082874|P1|Participant Flow|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901741|NCT01082874|O4|Outcome|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901742|NCT01082874|O3|Outcome|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901743|NCT01082874|O2|Outcome|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901744|NCT01082874|O1|Outcome|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901745|NCT01082874|E4|Reported Event|Placebo Clonidine and Placebo ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901746|NCT01082874|E3|Reported Event|Placebo Clonidine and Active ASA|"Placebo Clonidine: Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901747|NCT01082874|E2|Reported Event|Active Clonidine and Placebo ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Placebo ASA: Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901748|NCT01082874|E1|Reported Event|Active Clonidine and Active ASA|"Active Clonidine: Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.~Active ASA: Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery"
901749|NCT01082640|B4|Baseline|Total|Total of all reporting groups
901750|NCT01082640|B3|Baseline|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
901751|NCT01082640|B2|Baseline|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901752|NCT01082640|B1|Baseline|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
901753|NCT01082640|P3|Participant Flow|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
901756|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
901757|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
901758|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901759|NCT01082640|O3|Outcome|Febuxostat 80 mg QD|Participants with serum urate levels ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD from the Month 1 visit through Month 12.
901760|NCT01082640|O2|Outcome|Febuxostat 40 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit.
901761|NCT01082640|O1|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901762|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
901763|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901764|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
901765|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
901766|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901767|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
901768|NCT01082640|O3|Outcome|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
901769|NCT01082640|O2|Outcome|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901770|NCT01082640|O1|Outcome|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
901771|NCT01082640|E3|Reported Event|Febuxostat 40/80 mg QD|Participants initially received 40 mg febuxostat once daily (QD) and remained on 40 mg QD for up to 12 months if their serum urate (sUA) was <6.0 mg/dL at the Day 14 visit. Participants whose sUA was ≥6.0 mg/dL at the Day 14 visit received febuxostat 80 mg QD at the Month 1 visit, and for the remainder of the study.
901772|NCT01082640|E2|Reported Event|Febuxostat 30 mg BID|Febuxostat 30 mg, capsules, orally, twice daily (BID) for up to 12 months.
901773|NCT01082640|E1|Reported Event|Placebo|Placebo-matching capsules, orally, twice daily for up to 12 months.
901774|NCT01082614|B3|Baseline|Total|Total of all reporting groups
901775|NCT01082614|B2|Baseline|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
901776|NCT01082614|B1|Baseline|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
901777|NCT01082614|P2|Participant Flow|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
901778|NCT01082614|P1|Participant Flow|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
901779|NCT01082614|O2|Outcome|Goal Directed Therapy|"Intraoperative fluid management guided by stroke volume variation determined by arterial pressure pulse wave contour analysis~Vigileo: Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%."
901780|NCT01082614|O1|Outcome|Standard Fluid Management|Standard intraoperative fluid management as determined by usual monitoring and decision making applied by anesthesiology team
901781|NCT01082614|E2|Reported Event|Goal Directed Therapy|
901782|NCT01082614|E1|Reported Event|Standard Fluid Management|
901783|NCT01082588|B3|Baseline|Total|Total of all reporting groups
901784|NCT01082588|B2|Baseline|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901785|NCT01082588|B1|Baseline|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901786|NCT01082588|P2|Participant Flow|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901787|NCT01082588|P1|Participant Flow|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901788|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901789|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901790|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901791|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901792|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901793|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
911819|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
903788|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
901794|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901795|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901796|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901797|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901798|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901799|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901800|NCT01082588|O2|Outcome|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901801|NCT01082588|O1|Outcome|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
901802|NCT01082588|E2|Reported Event|Placebo|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Placebo: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
901803|NCT01082588|E1|Reported Event|Pravastatin|"pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks~Pravastatin: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks"
901804|NCT01082575|B1|Baseline|Major Surgery|Post Operative patients
901805|NCT01082575|P1|Participant Flow|Major Surgery|Post Operative patients
901806|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
901807|NCT01082575|O1|Outcome|General Care Floor|Observational General Care Floor Group
901808|NCT01082575|E1|Reported Event|Major Surgery|Post Operative patients
901809|NCT01082380|B1|Baseline|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901810|NCT01082380|P1|Participant Flow|PF-02341066 250 mg|Single oral dose of PF-02341066 250 milligram (mg) containing 100 micro-curie (μCi) Carbon -14[14C].
901811|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901812|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901813|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901814|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901815|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901816|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901817|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901818|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901819|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901820|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901821|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901822|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901823|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901824|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901825|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901826|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901827|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901828|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901829|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901830|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901831|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901832|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901833|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901834|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901835|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901836|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901837|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901838|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901839|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901840|NCT01082380|O1|Outcome|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901841|NCT01082380|E1|Reported Event|PF-02341066 250 mg|Single oral dose of PF-02341066 250 mg containing 100 μCi [14C].
901842|NCT01082367|B3|Baseline|Total|Total of all reporting groups
901843|NCT01082367|B2|Baseline|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
911820|NCT01055704|O2|Outcome|Codeine 30 mg|
901844|NCT01082367|B1|Baseline|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901845|NCT01082367|P2|Participant Flow|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901846|NCT01082367|P1|Participant Flow|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901847|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901848|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901849|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901850|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901851|NCT01082367|O2|Outcome|Placebo/TOBI|Participants randomized to placebo group received 0.9 % saline (NaCl) for 28 days bid in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the OL phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received TOBI for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901894|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901895|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
903149|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
901852|NCT01082367|O1|Outcome|TOBI (Tobramycin Inhaled Solution)/Placebo|Participants randomized to TOBI received the investigational treatment for 28 days twice daily (bi)d in the first treatment cycle. At the end of first treatment cycle, participants who were positive for P. aeruginosa entered the open label (OL) phase of the study and received TOBI for 28 days bid. Participants who were negative for P. aeruginosa at the end of first treatment cycle and agreed to participate in the cross-over treatment period received placebo for 28 days bid (second treatment cycle). Eligible participants were followed-up for up to 12-months, having visits every 3 months. If participants were detected P. aeruginosa positive, they received 28-days of OL TOBI. Participants who remained P.aeruginosa positive after TOBI OL treatment discontinued the study. Participants who became P.aeruginosa negative after OL TOBI treatment remained in the study.
901853|NCT01082367|E6|Reported Event|Off-treatment (Follow-up)|Off-treatment (follow-up)
901854|NCT01082367|E5|Reported Event|OL TOBI (Follow-up)|OL TOBI (follow-up)
901855|NCT01082367|E4|Reported Event|Off-treatment (Core)|Off-treatment (core)
901856|NCT01082367|E3|Reported Event|OL TOBI (Core)|OL TOBI (core)
901857|NCT01082367|E2|Reported Event|DB Placebo|DB Placebo
901858|NCT01082367|E1|Reported Event|DB TOBI|DB TOBI
901859|NCT01082328|B1|Baseline|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901860|NCT01082328|P1|Participant Flow|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901861|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901862|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901863|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901864|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901865|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901866|NCT01082328|O1|Outcome|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901867|NCT01082328|E1|Reported Event|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) once daily for 28 +/- 1 days.
901868|NCT01082211|B1|Baseline|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901869|NCT01082211|P1|Participant Flow|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901870|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901871|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901872|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901873|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901874|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901875|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901876|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901877|NCT01082211|O1|Outcome|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901878|NCT01082211|E1|Reported Event|Partial Breast Re-Irradiation|Partial Breast Re-Irradiation (PBrI) 3D-Conformal External Beam 1.5 Gy x 15 (BID) to 45 Gy Total
901879|NCT01082159|B1|Baseline|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
901880|NCT01082159|P1|Participant Flow|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
901881|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
901882|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous lumbar decompression using the mild Device Kit.
901883|NCT01082159|O1|Outcome|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
901884|NCT01082159|E1|Reported Event|Lumbar Decompression|Single arm cohort having percutaneous decompression using the mild Device Kit
901885|NCT01082081|B4|Baseline|Total|Total of all reporting groups
901886|NCT01082081|B3|Baseline|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901887|NCT01082081|B2|Baseline|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901888|NCT01082081|B1|Baseline|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901889|NCT01082081|P3|Participant Flow|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901890|NCT01082081|P2|Participant Flow|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901891|NCT01082081|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (total dose= 1000 mg), with 150 milliliter (mL) of water through oral route.
901892|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901893|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
911821|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
901896|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901897|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901898|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901899|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901900|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901901|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901902|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901903|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901904|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901905|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901906|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901907|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901908|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901909|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901910|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901911|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901912|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901913|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901914|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901915|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901916|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901917|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901918|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901919|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901920|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901921|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901922|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901923|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901924|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901925|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901926|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901927|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901928|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901929|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901930|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901931|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901932|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901933|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901934|NCT01082081|O3|Outcome|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901935|NCT01082081|O2|Outcome|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901936|NCT01082081|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901937|NCT01082081|E3|Reported Event|Placebo Caplet|Participants were administered with two placebo caplets, with 150 mL of water through oral route.
901938|NCT01082081|E2|Reported Event|Paracetamol Caplet 500 mg|Participants were administered with one paracetamol FD 500 mg caplet and one placebo caplet, with 150 mL of water through oral route.
901939|NCT01082081|E1|Reported Event|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (total dose= 1000 mg), with 150 mL of water through oral route.
901940|NCT01081951|B3|Baseline|Total|Total of all reporting groups
901941|NCT01081951|B2|Baseline|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
901942|NCT01081951|B1|Baseline|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
901943|NCT01081951|P2|Participant Flow|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
901944|NCT01081951|P1|Participant Flow|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
901945|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
901946|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
901947|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
901948|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
901949|NCT01081951|O2|Outcome|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
901950|NCT01081951|O1|Outcome|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
901951|NCT01081951|E2|Reported Event|Carboplatin AUC6/Paclitaxel|"Paclitaxel iv (175mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC6 Day 1 of a 21-day cycle) for 6 cycles.~Followed by a post-completion phase in which no study treatment was administered"
901952|NCT01081951|E1|Reported Event|Olaparib/Carboplatin AUC4/Paclitaxel|"Olaparib orally (po) (200mg bd Days 1-10 of a 21-day cycle) in combination with paclitaxel intravenous (iv) (175 mg/m2 Day 1 of a 21-day cycle) and carboplatin iv (AUC4 Day 1 of a 21-day cycle) for at least 4 cycles.~Followed by olaparib monotherapy maintenance (400mg bd continuous dosing)"
901953|NCT01081912|B1|Baseline|Open-label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label)
901954|NCT01081912|P3|Participant Flow|Double-Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
901955|NCT01081912|P2|Participant Flow|Double-Blind Treatment Phase|"Treatment Phase: Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
901956|NCT01081912|P1|Participant Flow|Conversion/Titration Phase - Open-Label|Conversion/Titration Phase: Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
901957|NCT01081912|O2|Outcome|Placebo Comparator|Placebo: Capsules, no active substance, shells identical to active comparator capsules
901958|NCT01081912|O1|Outcome|Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
901959|NCT01081912|E3|Reported Event|Double Blind Treatment Phase: Placebo Comparator|"Placebo: Capsules, no active substance, shells identical to active comparator capsules.~Placebo capsules twice daily for up to 12 weeks (Double-Blind Period)"
901960|NCT01081912|E2|Reported Event|Double Blind Treatment Phase: Hydrocodone Bitartrate Capsules|"Hydrocodone Bitartrate Controlled-Release Capsules twice daily up to 12 weeks (Double-Blind Period)~Hydrocodone bitartrate: dosage form: capsule~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
901961|NCT01081912|E1|Reported Event|Open-Label Conversion/Titration Phase|Hydrocodone Bitartrate Extended Release capsules twice daily for up to 6 weeks (Open-Label Period)
901962|NCT01081886|B3|Baseline|Total|Total of all reporting groups
901963|NCT01081886|B2|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
901964|NCT01081886|B1|Baseline|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
901965|NCT01081886|P2|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
901966|NCT01081886|P1|Participant Flow|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
901967|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
901968|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
901969|NCT01081886|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
901970|NCT01081886|O1|Outcome|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
901971|NCT01081886|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
901972|NCT01081886|E1|Reported Event|PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
901973|NCT01081873|B1|Baseline|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses. Age was available for 2,691 patients only; age was missing for 23 patients who were thus not included in the age results.
901974|NCT01081873|P1|Participant Flow|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901975|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901976|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901977|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901978|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901979|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901980|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants - MRI|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via MRI.
901981|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants - Echograph|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via an echograph (hyperechogenic zones).
901982|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants - Prostate Biopsy|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via a prostate biopsy.
901983|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants - Rectal Examination|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines who had tumor staging assessed via rectal examination.
901984|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901985|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a tissue type recorded at Baseline.
901986|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901987|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901988|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901989|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
901990|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Use at Any Visit|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had used any of the treatments at any visit.
901991|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
901992|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
901993|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
901994|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
901995|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
901996|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
901997|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
901998|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
901999|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
902000|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
902001|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
902002|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
902003|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
902004|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
902005|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
902006|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
902007|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
902008|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
902009|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
902010|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
902011|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
902012|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
902013|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
902014|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
902015|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
902016|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
902017|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
902018|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
903150|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
902019|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
902020|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
902021|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
902022|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
902023|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
902024|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
902025|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
902026|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
902027|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
902028|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
902029|NCT01081873|O10|Outcome|Advanced Prostate Cancer Participants - Last Available Record|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had any final value recorded.
902030|NCT01081873|O9|Outcome|Advanced Prostate Cancer Participants at Month 24|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 24.
902031|NCT01081873|O8|Outcome|Advanced Prostate Cancer Participants at Month 21|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 21.
902032|NCT01081873|O7|Outcome|Advanced Prostate Cancer Participants at Month 18|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 18.
902033|NCT01081873|O6|Outcome|Advanced Prostate Cancer Participants at Month 15|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 15.
902034|NCT01081873|O5|Outcome|Advanced Prostate Cancer Participants at Month 12|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 12
902035|NCT01081873|O4|Outcome|Advanced Prostate Cancer Participants at Month 9|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had had a value recorded at Month 9.
902036|NCT01081873|O3|Outcome|Advanced Prostate Cancer Participants at Month 6|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 6.
902037|NCT01081873|O2|Outcome|Advanced Prostate Cancer Participants at Month 3|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at Month 3.
902038|NCT01081873|O1|Outcome|Advanced Prostate Cancer Participants at Baseline|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines that had a value recorded at baseline.
902039|NCT01081873|E1|Reported Event|Advanced Prostate Cancer Participants|Participants with advanced prostate cancer treated with Lucrin /Lucrin- Tri-depot (leuprolide) or any other treatment with local reimbursement guidelines. No Baseline data was available for 3 patients who were thus excluded from all analyses.
902040|NCT01081834|B6|Baseline|Total|Total of all reporting groups
902041|NCT01081834|B5|Baseline|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks.
902042|NCT01081834|B4|Baseline|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902043|NCT01081834|B3|Baseline|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
902044|NCT01081834|B2|Baseline|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902045|NCT01081834|B1|Baseline|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902046|NCT01081834|P5|Participant Flow|High Glycemic Substudy: Canagliflozin 300 mg|In the High Glycemic Substudy, each patient received 300 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
902092|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902047|NCT01081834|P4|Participant Flow|High Glycemic Substudy: Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks only. No patients received treatment during the period Week 26 to Week 52.
902048|NCT01081834|P3|Participant Flow|Main Study: Canagliflozin 300 mg|In the Main Study, each patient received 300 mg of canagliflozin once daily for 52 weeks.
902049|NCT01081834|P2|Participant Flow|Main Study: Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902050|NCT01081834|P1|Participant Flow|Main Study: Placebo/Sitagliptin|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902051|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902052|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902053|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902054|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902055|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902056|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902057|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902058|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902059|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902060|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902061|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902062|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902063|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902064|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902065|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902066|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902067|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902068|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902069|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902070|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902071|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902072|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902073|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902074|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902075|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902076|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902077|NCT01081834|O1|Outcome|Placebo|In the Main study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902078|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902079|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902080|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902081|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902082|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902083|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902084|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902085|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902086|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902087|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902088|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902089|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902090|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902091|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902093|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the High Glycemic Substudy, each pateint received 300 mg of canagliflozin once daily for 26 weeks.
902094|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the High Glycemic Substudy, each patient received 100 mg of canagliflozin once daily for 26 weeks.
902095|NCT01081834|O1|Outcome|Placebo|In the High Glycemic Substudy, no patients received placebo.
902096|NCT01081834|O3|Outcome|Canagliflozin 300 mg|In the Main Study, each pateint received 300 mg of canagliflozin once daily for 52 weeks.
902097|NCT01081834|O2|Outcome|Canagliflozin 100 mg|In the Main Study, each patient received 100 mg of canagliflozin once daily for 52 weeks.
902098|NCT01081834|O1|Outcome|Placebo|In the Main Study, each patient recieved matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52.
902099|NCT01081834|E8|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
902100|NCT01081834|E7|Reported Event|High Glycemic Substudy (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 26 weeks. Data are only available for Baseline to Week 26.
902101|NCT01081834|E6|Reported Event|Main Study (Baseline to Week 52): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
902102|NCT01081834|E5|Reported Event|Main Study (Baseline to Week 52): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 52.
902103|NCT01081834|E4|Reported Event|Main Study (Baseline to Week 52): Placebo/Sitagliptin|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 52.
902104|NCT01081834|E3|Reported Event|Main Study (Baseline to Week 26): Cana 300 mg|Each patient received 300 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
902105|NCT01081834|E2|Reported Event|Main Study (Baseline to Week 26): Cana 100 mg|Each patient received 100 mg of canagliflozin (Cana) once daily for 52 weeks. Data are presented for Baseline to Week 26.
902106|NCT01081834|E1|Reported Event|Main Study (Baseline to Week 26): Placebo|Each patient received matching placebo once daily for 26 weeks and were then switched from placebo to 100 mg of sitagliptin once daily until Week 52. Data are presented for Baseline to Week 26.
902107|NCT01081795|B4|Baseline|Total|Total of all reporting groups
902108|NCT01081795|B3|Baseline|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902109|NCT01081795|B2|Baseline|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902110|NCT01081795|B1|Baseline|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902111|NCT01081795|P3|Participant Flow|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902112|NCT01081795|P2|Participant Flow|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902113|NCT01081795|P1|Participant Flow|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902114|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902115|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902116|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902284|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902117|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902118|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902119|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902120|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902121|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902122|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902123|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902124|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902125|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902126|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902127|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902128|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902129|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902130|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902131|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902213|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902132|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902133|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902134|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902135|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902136|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902137|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902138|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902139|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902140|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902141|NCT01081795|O3|Outcome|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902142|NCT01081795|O2|Outcome|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902143|NCT01081795|O1|Outcome|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902144|NCT01081795|E3|Reported Event|Placebo|In titration period, matching placebo tablet once daily in evening orally for 7 days; followed by matching placebo tablet twice daily orally from Day 8 to Day 14; followed by matching placebo tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; followed by 2 matching placebo tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902145|NCT01081795|E2|Reported Event|Topiramate 100 mg|In titration period, topiramate 25 mg tablet once daily in the evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily (1 tablet in the morning and 2 tablets in the evening) orally from Day 15 to Day 21; then 2 topiramate 25 mg tablets twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902146|NCT01081795|E1|Reported Event|Topiramate (JNS019) 50 mg|In titration period, topiramate 25 milligram (mg) tablet once daily in evening orally for 7 days; then topiramate 25 mg tablet twice daily orally from Day 8 to Day 14; then topiramate 25 mg tablet twice daily along with matching placebo tablet once daily in the evening orally from Day 15 to Day 21; then topiramate 25 mg tablet along with matching placebo tablet twice daily orally from Day 22 to Day 28 and continued further for 18 weeks in the fixed dose period
902147|NCT01081769|B3|Baseline|Total|Total of all reporting groups
902148|NCT01081769|B2|Baseline|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
902149|NCT01081769|B1|Baseline|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
902150|NCT01081769|P2|Participant Flow|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
902151|NCT01081769|P1|Participant Flow|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
902152|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902153|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902154|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902155|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902156|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902157|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902158|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902159|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902160|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902161|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902162|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902163|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902164|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902165|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902166|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902167|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902168|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902169|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902170|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902171|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902172|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902173|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902174|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902175|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902176|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902177|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902178|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902179|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902180|NCT01081769|O2|Outcome|Oral Antipsychotics|oral antipsychotics daily treatment according to local label for maximally 24 months
902181|NCT01081769|O1|Outcome|Paliperidone Palmitate|paliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
902182|NCT01081769|E2|Reported Event|Oral Antipsychotics|Oral antipsychotics daily treatment according to local label for maximally 24 months
902279|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
911822|NCT01055704|E4|Reported Event|Placebo|
902183|NCT01081769|E1|Reported Event|Paliperidone Palmitate|2 weeks oral paliperidone treatment followed by intramuscular injection with 150 mg paliperidone palmitate equivalent on Day 1 of the core treatment phase, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
902184|NCT01081665|B1|Baseline|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902185|NCT01081665|P1|Participant Flow|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902186|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902187|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902188|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902189|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902190|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902191|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902192|NCT01081665|O1|Outcome|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902193|NCT01081665|E1|Reported Event|Chronic Kidney Disease|All eligible patients treated with IV Paricalcitol (Zemplar)
902194|NCT01081626|B3|Baseline|Total|Total of all reporting groups
902195|NCT01081626|B2|Baseline|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902196|NCT01081626|B1|Baseline|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902197|NCT01081626|P2|Participant Flow|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902198|NCT01081626|P1|Participant Flow|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902199|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902200|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902201|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902202|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902203|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902204|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902205|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902206|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902207|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902208|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902209|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902210|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902211|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902212|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902285|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
902214|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902215|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902216|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902217|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902218|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902219|NCT01081626|O2|Outcome|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902220|NCT01081626|O1|Outcome|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902221|NCT01081626|E2|Reported Event|Low Dose (LD) Protocol|Gonal-f® (follitropin alpha) injection 75 IU subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 7 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902222|NCT01081626|E1|Reported Event|Chronic Low Dose (CLD) Protocol|Gonal-f® (follitropin alpha) injection 75 International Units (IU) subcutaneously administered for 7 days. Dose increased by 37.5 IU on Day 14 of stimulation period, at intervals of 7 days up to Day 35 of stimulation period or until ovarian response observed.
902223|NCT01081301|B1|Baseline|Living With Hope Program|"The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902224|NCT01081301|P1|Participant Flow|Living With Hope Program|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902225|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
902226|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
902227|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
902228|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
902229|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
902230|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902231|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
902232|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
902233|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
902234|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
902235|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
902236|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902237|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
902238|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
902239|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
902240|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
902241|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
902242|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|"Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902280|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902281|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
902282|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902243|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|"12 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902244|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|"6 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902245|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|"3 months Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902246|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|"Day 14 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902247|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|"Day 7 Receive Living with Hope Program~Living with Hope Program : The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
902248|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|Baseline Measure
902249|NCT01081301|O6|Outcome|Living With Hope Program [12 Months]|
902250|NCT01081301|O5|Outcome|Living With Hope Program [6 Months]|
902251|NCT01081301|O4|Outcome|Living With Hope Program [3 Months]|
902252|NCT01081301|O3|Outcome|Living With Hope Program [Day 14]|
902253|NCT01081301|O2|Outcome|Living With Hope Program [Day 7]|
902254|NCT01081301|O1|Outcome|Living With Hope Program [Baseline]|
902255|NCT01081301|E6|Reported Event|Living With Hope Program [12 Months]|
902256|NCT01081301|E5|Reported Event|Living With Hope Program [6 Months]|
902257|NCT01081301|E4|Reported Event|Living With Hope Program [3 Months]|
902258|NCT01081301|E3|Reported Event|Living With Hope Program [Day 14]|
902259|NCT01081301|E2|Reported Event|Living With Hope Program [Day 7]|
902260|NCT01081301|E1|Reported Event|Living With Hope Program [Baseline]|
902261|NCT01081249|B1|Baseline|Active Drug|"placebo~intranasal oxytocin: single dose of 40 IU intranasal oxytocin or similar volume of placebo~placebo: single dose of 40 IU intranasal oxytocin or similar volume of placebo"
902262|NCT01081249|P2|Participant Flow|Placebo Then Oxytocin|Participants received a single dose of intranasal placebo prior to the first psychotherapy session; prior to the second psychotherapy session the participants received a single dose of 40 IU intranasal oxytocin.
902263|NCT01081249|P1|Participant Flow|Oxytocin Then Placebo|Participants received a single dose of 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a similar dose of intranasal placebo.
902264|NCT01081249|O2|Outcome|Active Drug|A dose of 40 IU intranasal oxytocin was administered prior to the psychotherapy session.
902265|NCT01081249|O1|Outcome|Placebo|A dose of intranasal placebo was administered prior to the psychotherapy session.
902266|NCT01081249|E2|Reported Event|Oxytocin Then Placebo|Participants received 40 IU intranasal oxytocin prior to the first psychotherapy session; prior to the second psychotherapy session they received a comparable dose of intranasal placebo spray.
902267|NCT01081249|E1|Reported Event|Placebo Then Oxytocin|Participants received intranasal placebo spray prior to the first psychotherapy session; prior to the second psychotherapy session they received 40 IU intranasal oxytocin.
902268|NCT01081145|B1|Baseline|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902269|NCT01081145|P2|Participant Flow|Placebo|Administered as a once-daily oral dose
902270|NCT01081145|P1|Participant Flow|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902271|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902272|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902273|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902274|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902275|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902276|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902277|NCT01081145|O1|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902278|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902286|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902287|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
902288|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902289|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
902290|NCT01081145|O2|Outcome|Guanfacine Hydrochloride|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902291|NCT01081145|O1|Outcome|Placebo|Administered as a once-daily oral dose
902292|NCT01081145|E3|Reported Event|Guanfacine Hydrochloride (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902293|NCT01081145|E2|Reported Event|Placebo (Randomized-Withdrawal Phase)|Administered as a once-daily oral dose
902294|NCT01081145|E1|Reported Event|Guanfacine Hydrochloride (Open-Label Phase)|Administered as a once-daily oral dose between 1-7mg/day depending on age and weight
902295|NCT01081132|B3|Baseline|Total|Total of all reporting groups
902296|NCT01081132|B2|Baseline|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902297|NCT01081132|B1|Baseline|PLACEBO|Orally administered a once-daily dose
902298|NCT01081132|P2|Participant Flow|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902299|NCT01081132|P1|Participant Flow|PLACEBO|Orally administered a once-daily dose
902300|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902301|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902302|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902303|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902304|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902305|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902306|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902307|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902308|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902309|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902310|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902311|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902312|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902313|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902314|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902315|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902316|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902317|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902318|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902319|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902320|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902321|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902322|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902323|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902324|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902325|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902326|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902327|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902328|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902329|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902330|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902331|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902332|NCT01081132|O2|Outcome|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902333|NCT01081132|O1|Outcome|PLACEBO|Orally administered a once-daily dose
902334|NCT01081132|E2|Reported Event|SPD503|Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight).
902335|NCT01081132|E1|Reported Event|PLACEBO|Orally administered a once-daily dose
902336|NCT01081041|B4|Baseline|Total|Total of all reporting groups
902349|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
903780|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
902337|NCT01081041|B3|Baseline|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902338|NCT01081041|B2|Baseline|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902339|NCT01081041|B1|Baseline|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902340|NCT01081041|P3|Participant Flow|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902341|NCT01081041|P2|Participant Flow|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902342|NCT01081041|P1|Participant Flow|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902343|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902344|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902345|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902346|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902347|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902348|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902504|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
902505|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
902350|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902351|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902352|NCT01081041|O1|Outcome|All Participants (Cetuximab)|"United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~OR~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly."
902353|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902354|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902355|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902356|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902357|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902358|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902359|NCT01081041|O3|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by Boehringer Ingelheim (BI), 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902360|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902361|NCT01081041|O1|Outcome|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~United States (US) commercial cetuximab, manufactured by ImClone, 400 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cisplatin (cis) 100 mg/m^2 or carboplatin (carbo) area under the curve (AUC) 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-Fluorouracil (5-FU): 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902362|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI),|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902363|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902364|NCT01081041|O2|Outcome|Part 2: Combination Therapy: Cetuximab (Manufactured by BI)|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902365|NCT01081041|O1|Outcome|Part 2: Combination Therapy: Cetuximab (US Commercial)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle."
902366|NCT01081041|E3|Reported Event|Part 2: Cetuximab (Manufactured by BI), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~Cetuximab, manufactured by BI, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly BI-manufactured cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902367|NCT01081041|E2|Reported Event|Part 2: Cetuximab (US Commercial), Cis or Carbo, 5-FU|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902368|NCT01081041|E1|Reported Event|Part 1: Safety Lead-In (Cetuximab, Cis or Carbo, 5-FU)|"Combination Therapy (maximum 6 cycles):~US commercial cetuximab, manufactured by ImClone, 400 mg/m^2 IV infusion on Day 1 of Cycle 1; subsequently 250 mg/m^2 IV infusion weekly.~Cis 100 mg/m^2 or carbo AUC 5, up to a maximum 750 mg dose, IV infusion on Day 1 of every 21-day cycle, 1 hour after cetuximab infusion.~5-FU: 1000 mg/m^2 IV infusion on Days 1 through 4 of every 21-day cycle.~Monotherapy Therapy:~Participants who did not experience disease progression after 6 cycles of combination therapy continued on weekly US commercial cetuximab monotherapy 250 mg/m^2 until disease progression, unacceptable toxicity, or other withdrawal criteria were met."
902369|NCT01080807|B3|Baseline|Total|Total of all reporting groups
902370|NCT01080807|B2|Baseline|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902371|NCT01080807|B1|Baseline|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902372|NCT01080807|P2|Participant Flow|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902373|NCT01080807|P1|Participant Flow|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902374|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902506|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
902507|NCT01080677|E3|Reported Event|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
902508|NCT01080677|E2|Reported Event|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
902509|NCT01080677|E1|Reported Event|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
902375|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902376|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902377|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902378|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902379|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902380|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902381|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902382|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902383|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902384|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902385|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902510|NCT01080625|B4|Baseline|Total|Total of all reporting groups
902511|NCT01080625|B3|Baseline|Control|10 ml of normal saline is administered at the time of reperfusion
902512|NCT01080625|B2|Baseline|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
902386|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902387|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902388|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902389|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902390|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902391|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902392|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902393|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902394|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902395|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902396|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902513|NCT01080625|B1|Baseline|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
902514|NCT01080625|P3|Participant Flow|Control|10 ml of normal saline is administered at the time of reperfusion
902515|NCT01080625|P2|Participant Flow|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
902397|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902398|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902399|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902400|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902401|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902402|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902403|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902404|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902405|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902406|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902407|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902516|NCT01080625|P1|Participant Flow|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
902517|NCT01080625|O3|Outcome|Control|10 ml of normal saline is administered at the time of reperfusion
902518|NCT01080625|O2|Outcome|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
902408|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902409|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902410|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902411|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902412|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902413|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902414|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902415|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902416|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902417|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902418|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902519|NCT01080625|O1|Outcome|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
902520|NCT01080625|E3|Reported Event|Control|10 ml of normal saline is administered at the time of reperfusion
902521|NCT01080625|E2|Reported Event|Epinephrine|10 mcg of epinephrine is administered iv at the time of reperfusion
902419|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902420|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902421|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902422|NCT01080807|O2|Outcome|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902423|NCT01080807|O1|Outcome|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902424|NCT01080807|E2|Reported Event|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902425|NCT01080807|E1|Reported Event|150 mg/Day Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
902426|NCT01080794|B5|Baseline|Total|Total of all reporting groups
902427|NCT01080794|B4|Baseline|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902428|NCT01080794|B3|Baseline|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902522|NCT01080625|E1|Reported Event|Phenylephrine|100 mcg of phenylephrine is administered at the time of reperfusion
902523|NCT01080391|B3|Baseline|Total|Total of all reporting groups
902524|NCT01080391|B2|Baseline|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902429|NCT01080794|B2|Baseline|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902430|NCT01080794|B1|Baseline|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902431|NCT01080794|P4|Participant Flow|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902432|NCT01080794|P3|Participant Flow|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902433|NCT01080794|P2|Participant Flow|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902434|NCT01080794|P1|Participant Flow|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902435|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902525|NCT01080391|B1|Baseline|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902595|NCT01080209|P1|Participant Flow|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
902596|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
902436|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902437|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902438|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902439|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902440|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902441|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902442|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902574|NCT01080248|B1|Baseline|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
902575|NCT01080248|P1|Participant Flow|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
902576|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
902443|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902444|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902445|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902446|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902447|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902448|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902449|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902577|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
902578|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
902579|NCT01080248|O1|Outcome|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
902450|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902451|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902452|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902453|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902454|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902455|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902456|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902580|NCT01080248|E1|Reported Event|Arm 1 (Gemcitabine & Pazopanib)|"Gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle.~Pazopanib 800 mg PO daily of each 28 day cycle."
902581|NCT01080209|B8|Baseline|Total|Total of all reporting groups
902582|NCT01080209|B7|Baseline|Sham|Patients who received sham in a previous study.
902583|NCT01080209|B6|Baseline|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
917290|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
902457|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902458|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902459|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902460|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902461|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902462|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902463|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902584|NCT01080209|B5|Baseline|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
902585|NCT01080209|B4|Baseline|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
902586|NCT01080209|B3|Baseline|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
902587|NCT01080209|B2|Baseline|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
902464|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902465|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902466|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902467|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902468|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902469|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902470|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902588|NCT01080209|B1|Baseline|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
902589|NCT01080209|P7|Participant Flow|Sham|Patients who received sham in a previous study.
902590|NCT01080209|P6|Participant Flow|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
902591|NCT01080209|P5|Participant Flow|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
902471|NCT01080794|O4|Outcome|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902472|NCT01080794|O3|Outcome|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902473|NCT01080794|O2|Outcome|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902474|NCT01080794|O1|Outcome|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902475|NCT01080794|E4|Reported Event|Double Sham rTMS|"Sham rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902476|NCT01080794|E3|Reported Event|DLPFC Active rTMS + M1 Sham rTMS|"High frequency stimulation of the dorsolateral prefrontal cortex (DLPFC) and sham stimulation of the primary motor cortex (M1).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902477|NCT01080794|E2|Reported Event|M1 Active rTMS + DLPFC Sham rTMS|"High frequency stimulation of the primary motor cortex (M1) and sham stimulation of the dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902592|NCT01080209|P4|Participant Flow|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
902593|NCT01080209|P3|Participant Flow|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
902594|NCT01080209|P2|Participant Flow|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
917291|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
902478|NCT01080794|E1|Reported Event|Double rTMS|"High frequency rTMS stimulation of the bilateral primary motor cortex (M1) and left dorsolateral prefrontal cortex (DLPFC).~Repetitive transcranial magnetic stimulation (rTMS): DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
902479|NCT01080768|B3|Baseline|Total|Total of all reporting groups
902480|NCT01080768|B2|Baseline|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902481|NCT01080768|B1|Baseline|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902482|NCT01080768|P2|Participant Flow|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902483|NCT01080768|P1|Participant Flow|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902484|NCT01080768|O2|Outcome|Amlodipine+ Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902485|NCT01080768|O1|Outcome|Aliskiren/Amlodipine + Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902486|NCT01080768|E2|Reported Event|Amlodipine and Placebo to Aliskiren/Amlodipine|"During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902487|NCT01080768|E1|Reported Event|Aliskiren/Amlodipine and Placebo to Amlodipine|"During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patient up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine.~The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day."
902488|NCT01080677|B4|Baseline|Total|Total of all reporting groups
902489|NCT01080677|B3|Baseline|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
902490|NCT01080677|B2|Baseline|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
902491|NCT01080677|B1|Baseline|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
902492|NCT01080677|P3|Participant Flow|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
902493|NCT01080677|P2|Participant Flow|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
902494|NCT01080677|P1|Participant Flow|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
902495|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
902496|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
902497|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
902498|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
902499|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
902500|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
902501|NCT01080677|O3|Outcome|High Dose|Participants received caffeine/propranolol 1000/40 mg combination tablet (single dose)
902502|NCT01080677|O2|Outcome|Low Dose|Participants received caffeine/propranolol 400/40 mg combination tablet (single dose)
902503|NCT01080677|O1|Outcome|Placebo|Participants received placebo to match caffeine/propranolol (single dose)
902526|NCT01080391|P2|Participant Flow|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902527|NCT01080391|P1|Participant Flow|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902528|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902529|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902530|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902531|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902532|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902533|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902534|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902535|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902536|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902537|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902538|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902539|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902540|NCT01080391|O2|Outcome|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902541|NCT01080391|O1|Outcome|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902542|NCT01080391|E2|Reported Event|Carfilzomib, Lenalidomide, and Dexamethasone (CRd)|Treatment was administered in cycles every 28 days. Carfilzomib 20 mg/m2 was administered intravenously (IV) on Days 1 and 2 of Cycle 1, escalating to 27 mg/m2 on Days 8, 9, 15, and 16 of Cycle 1 and continuing on Days 1, 2, 8, 9, 15, and 16 of Cycle 2 through Cycle 12 and then from Cycle 13 through Cycle 18, 27 mg/m2 on Days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on Days 1 to 21 from Cycle 1 through Cycle 18 and from Cycle 19 and higher. Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22 from Cycle 1 through Cycle 18 and from Cycle 19 and higher.
902543|NCT01080391|E1|Reported Event|Lenalidomide and Dexamethasone (Rd)|Treatment was administered in cycles repeated every 28 days. Lenalidomide 25 mg was administered orally on Days 1 to 21 and Dexamethasone 40 mg was administered orally or IV on Days 1, 8, 15, and 22.
902544|NCT01080326|B1|Baseline|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
902545|NCT01080326|P1|Participant Flow|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
902546|NCT01080326|O1|Outcome|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
902547|NCT01080326|E1|Reported Event|Endoscopic Translumenal Omental Patch|"Patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix the Endoscopic Translumenal Omental Patch in place.~Endoscopic Translumenal Omental Patch: The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place."
902548|NCT01080300|B3|Baseline|Total|Total of all reporting groups
902549|NCT01080300|B2|Baseline|Sugar Pill|Placebo 1800 mg
902550|NCT01080300|B1|Baseline|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
902551|NCT01080300|P2|Participant Flow|Sugar Pill|Placebo 1800 mg
902552|NCT01080300|P1|Participant Flow|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
902553|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
902554|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
902555|NCT01080300|O2|Outcome|Sugar Pill|Placebo 1800 mg
902556|NCT01080300|O1|Outcome|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
902557|NCT01080300|E2|Reported Event|Sugar Pill|Placebo 1800 mg
902558|NCT01080300|E1|Reported Event|G-ER 1800 mg|Gabapentin extended-release (G-ER) 1800 mg
902559|NCT01080261|B1|Baseline|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902560|NCT01080261|P1|Participant Flow|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902561|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902562|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902563|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902564|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902565|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902566|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902567|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902568|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902569|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902570|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902571|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902572|NCT01080261|O1|Outcome|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902573|NCT01080261|E1|Reported Event|PROMUS Element|Participants enrolled to receive a PROMUS Element everolimus-eluting stent (investigational device)
902597|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
902598|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
902599|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
902600|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
902601|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
902602|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
902603|NCT01080209|O7|Outcome|Sham|Patients who received sham in a previous study.
902604|NCT01080209|O6|Outcome|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
902605|NCT01080209|O5|Outcome|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
902606|NCT01080209|O4|Outcome|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
902607|NCT01080209|O3|Outcome|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
902608|NCT01080209|O2|Outcome|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
902609|NCT01080209|O1|Outcome|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
902610|NCT01080209|E7|Reported Event|Sham|Patients who received sham in a previous study.
902611|NCT01080209|E6|Reported Event|Brimo PS DDS® 50 μg (1 Implant)|Patients who received Brimo PS DDS® 50 μg (1 implant) in a previous study.
902612|NCT01080209|E5|Reported Event|Brimo PS DDS® 100 μg (1 Implant)|Patients who received Brimo PS DDS® 100 μg (1 implant) in a previous study.
902613|NCT01080209|E4|Reported Event|Brimo PS DDS® 200 μg (1 Implant)|Patients who received Brimo PS DDS® 200 μg (1 implant) in a previous study.
902614|NCT01080209|E3|Reported Event|Brimo PS DDS® 200 μg (2 Implants)|Patients who received Brimo PS DDS® 200 μg (2 implants) in a previous study.
902615|NCT01080209|E2|Reported Event|Brimo PS DDS® 400 μg (1 Implant)|Patients who received Brimo PS DDS® 400 μg (1 implant) in a previous study.
902616|NCT01080209|E1|Reported Event|Brimo PS DDS® 400 μg (2 Implants)|Patients who received Brimo PS DDS® 400 μg (2 implants) in a previous study.
902617|NCT01080131|B3|Baseline|Total|Total of all reporting groups
902618|NCT01080131|B2|Baseline|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
902619|NCT01080131|B1|Baseline|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
902620|NCT01080131|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
902621|NCT01080131|P1|Participant Flow|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
902622|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902623|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902624|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902625|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the Ccre study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902626|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902627|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902628|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902629|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902630|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902631|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902632|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902633|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902634|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902635|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902636|NCT01080131|O2|Outcome|Triam Switched to Canakinumab|Participants who received triamcinolone acetonide (triam) 40 mg in the core study and who were switched to canakinumab 150 mg for treatment of new flares in extension study 2. Data are reported for the first post-baseline flare treated with canakinumab.
902637|NCT01080131|O1|Outcome|Re-treated With Canakinumab 150 mg|Participants who received canakinumab 150 mg in the core study and who were re-treated with canakinumab 150 mg for new flares during the overall 72 weeks. Data are reported for the last post-baseline flare for participants in this arm.
902638|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
902639|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
902640|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to switch to open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year. Triamcinolone acetonide was not to be administered in the second extension study."
902641|NCT01080131|O1|Outcome|Canakinumab 150 mg|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc for any new flare for an additional year, for a total duration of 18 months."
902642|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902746|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902643|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902644|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902645|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902646|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902647|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902648|NCT01080131|O6|Outcome|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
902649|NCT01080131|O5|Outcome|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
902650|NCT01080131|O4|Outcome|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
902651|NCT01080131|O3|Outcome|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
902652|NCT01080131|O2|Outcome|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
902653|NCT01080131|O1|Outcome|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
902654|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902655|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902656|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902712|NCT01079988|B4|Baseline|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
902657|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902658|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902659|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902660|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902661|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902662|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902663|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902664|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902665|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902666|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902667|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902668|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902669|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902713|NCT01079988|B3|Baseline|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
917292|NCT01037244|O4|Outcome|Placebo|Placebo tablets
902670|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902671|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902672|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902673|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902674|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|"Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare."
902675|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same treatment for another 12 weeks for any new gout flare.
902676|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902677|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902678|NCT01080131|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
902679|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902680|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902681|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902682|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902683|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902684|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902685|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902744|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902686|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902687|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902688|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902689|NCT01080131|O2|Outcome|Triamcinolone Acetonide 40 mg|Participants received 1 intramuscular injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902690|NCT01080131|O1|Outcome|Canakinumab 150 mg|Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.
902691|NCT01080131|E6|Reported Event|Triam: After Switch to Canakinumab|Participants who were treated with triamcinolone acetonide during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred after the switch to canakinumab.
902692|NCT01080131|E5|Reported Event|Triam: Before Switch to Canakinumab|Participants who were treated with triamcinolone acetonide (triam) during the core study and extension study 1 and who were switched to open-label on demand treatment with canakinumab 150 mg sc upon new flare in extension study 2. Data are reported for adverse events that occurred before the switch to canakinumab.
902693|NCT01080131|E4|Reported Event|All Triamcinolone Acetonide|"Participants received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 sc injection of placebo to canakinumab on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. In the first extension study participants completing the 12 week core study could continue to be treated on demand with the same study treatment another 12 weeks for any new gout flare.~Reported data include all adverse events that occurred during the core study and extension studies 1 and 2, before participants were switched to canakinumab."
902694|NCT01080131|E3|Reported Event|Canakinumab: After Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population after re-treatment with canakinumab.
902695|NCT01080131|E2|Reported Event|Canakinumab: Before Retreatment|Participants who received canakinumab in the core study and were re-treated with canakinumab during the core study or extension study 1 or 2. Reported data include adverse events that occurred in this re-treated population before re-treatment with canakinumab.
902696|NCT01080131|E1|Reported Event|All Canakinumab|"Participants received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Participants could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose.~In the first extension study, participants completing the 12 week core study could continue to be treated on demand with the same study treatment for an additional 12 weeks for any new gout flare.~In the second extension study participants were to receive open-label on demand treatment with canakinumab 150 mg sc upon new flare for 1 year, for a total duration of 18 months."
902697|NCT01080118|B3|Baseline|Total|Total of all reporting groups
902698|NCT01080118|B2|Baseline|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
902699|NCT01080118|B1|Baseline|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
902700|NCT01080118|P4|Participant Flow|Video Laryngoscope Patients|Patients who were intubated using the video laryngoscope by interns or medical student.
902701|NCT01080118|P3|Participant Flow|Rigid Laryngoscope Patients|Patients who were intubated using the rigid laryngoscope by the medical student of intern.
902702|NCT01080118|P2|Participant Flow|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
902703|NCT01080118|P1|Participant Flow|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
902704|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
902705|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
902706|NCT01080118|O2|Outcome|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
902707|NCT01080118|O1|Outcome|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
902708|NCT01080118|E2|Reported Event|Video Laryngoscope Group|Medical students or interns attempting intubation with Airtraq video laryngoscope
902709|NCT01080118|E1|Reported Event|Rigid Laryngoscope Group|Medical students or interns attempting intubation with standard size 3 Macintosh laryngoscope
902710|NCT01079988|B6|Baseline|Total|Total of all reporting groups
902711|NCT01079988|B5|Baseline|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
902745|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902714|NCT01079988|B2|Baseline|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
902715|NCT01079988|B1|Baseline|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
902716|NCT01079988|P5|Participant Flow|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
902717|NCT01079988|P4|Participant Flow|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
902718|NCT01079988|P3|Participant Flow|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
902719|NCT01079988|P2|Participant Flow|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
902720|NCT01079988|P1|Participant Flow|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
902721|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
902722|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
902723|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
902724|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
902725|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
902726|NCT01079988|O5|Outcome|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
902727|NCT01079988|O4|Outcome|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
902728|NCT01079988|O3|Outcome|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
902729|NCT01079988|O2|Outcome|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
902730|NCT01079988|O1|Outcome|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
902731|NCT01079988|E5|Reported Event|Systemic Corticosteroids/Methotrexate|"Corticosteroid starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%.~Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks."
902732|NCT01079988|E4|Reported Event|Methotrexate|Starting dose 20 – 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
902733|NCT01079988|E3|Reported Event|Systemic Corticosteroids|Starting dose 0.25 – 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
902734|NCT01079988|E2|Reported Event|Retinoids|Starting dose 25 – 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
902735|NCT01079988|E1|Reported Event|Cyclosporin|Starting dose 4.0 – 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
902736|NCT01079962|B3|Baseline|Total|Total of all reporting groups
902737|NCT01079962|B2|Baseline|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902738|NCT01079962|B1|Baseline|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902739|NCT01079962|P2|Participant Flow|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902740|NCT01079962|P1|Participant Flow|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902741|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902742|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902743|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
917293|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
902747|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902748|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902749|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902750|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902751|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902752|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902753|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902754|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902755|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902756|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902757|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902758|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902759|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902760|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902761|NCT01079962|O2|Outcome|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902762|NCT01079962|O1|Outcome|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902763|NCT01079962|E2|Reported Event|Atenolol|Single dose of atenolol tablet (TENORMIN®) administered orally at a dose of 50 mg daily every morning for 12 weeks.
902764|NCT01079962|E1|Reported Event|Bisoprolol|Single dose of bisoprolol tablet (CONCOR®) administered orally at a dose of 5 milligram (mg) daily every morning for 12 weeks.
902765|NCT01079949|B3|Baseline|Total|Total of all reporting groups
902766|NCT01079949|B2|Baseline|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902767|NCT01079949|B1|Baseline|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902768|NCT01079949|P2|Participant Flow|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902769|NCT01079949|P1|Participant Flow|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902770|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902835|NCT01079936|E2|Reported Event|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
903151|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
902771|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902772|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902773|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902774|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902775|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902776|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902777|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902778|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902779|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902836|NCT01079936|E1|Reported Event|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
903781|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
902780|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902781|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902782|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902783|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902784|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902785|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902786|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902787|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902788|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902798|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902789|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902790|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902791|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902792|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902793|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902794|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902795|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902796|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902797|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902833|NCT01079936|E4|Reported Event|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
903782|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
902799|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902800|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902801|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902802|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902803|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902804|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902805|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902806|NCT01079949|O2|Outcome|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902807|NCT01079949|O1|Outcome|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902834|NCT01079936|E3|Reported Event|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
903783|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
902808|NCT01079949|E2|Reported Event|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from S1 at a staring dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day. Gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 mg/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902809|NCT01079949|E1|Reported Event|r-hFSH + r-hLH|Recombinant human follicle stimulating hormone (r-hFSH) injection administered subcutaneously once daily from Day 1 of stimulation period (S1) at a starting dose of 300-450 international units (IU) and then dose adjusted depending on the ovarian response till recombinant human chorionic gonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection administered subcutaneously once daily at a constant dose of 150 IU in the afternoon and gonadotropin releasing hormone (GnRH) antagonists injection administered subcutaneously once daily at a dose of 0.25 milligram (mg)/day in the morning, depending on the follicular growth (when the lead follicle is greater than 14 millimeter [mm] in size), along with r-hFSH treatment as a separate injection till r-hCG administration day. On r-hCG day 250-500 microgram of r-hCG was administered subcutaneously once.
902810|NCT01079936|B5|Baseline|Total|Total of all reporting groups
902811|NCT01079936|B4|Baseline|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902812|NCT01079936|B3|Baseline|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902813|NCT01079936|B2|Baseline|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902814|NCT01079936|B1|Baseline|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902815|NCT01079936|P5|Participant Flow|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902816|NCT01079936|P4|Participant Flow|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902817|NCT01079936|P3|Participant Flow|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902818|NCT01079936|P2|Participant Flow|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902819|NCT01079936|P1|Participant Flow|Phase I: Lenalidomide + High-Dose Melphalan|Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902820|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902821|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902822|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902823|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902824|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902825|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902826|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902827|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902828|NCT01079936|O4|Outcome|100 mg Lenalidomide|Lenalidomide dose level 100 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902829|NCT01079936|O3|Outcome|75 mg Lenalidomide|Lenalidomide dose level 75 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902830|NCT01079936|O2|Outcome|50 mg Lenalidomide|Lenalidomide dose level 50 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902831|NCT01079936|O1|Outcome|25 Mg Lenalidomide|Lenalidomide dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m^2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.
902832|NCT01079936|O1|Outcome|Lenalidomide + High-Dose Melphalan|"Lenalidomide beginning dose level 25 mg by mouth (PO) on Days -8 to -2. High-Dose Melphalan dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion. Stem cell infusion on Day 0.~Lenalidomide: Beginning dose level 25 mg by mouth (PO) on Days -8 to -2~Melphalan: Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion~Stem Cell Infusion: Stem cell infusion on Day 0."
902837|NCT01079832|B1|Baseline|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902838|NCT01079832|P1|Participant Flow|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902839|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902840|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902841|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902842|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902843|NCT01079832|O1|Outcome|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902844|NCT01079832|E1|Reported Event|Arm I: CyberKnife Radiosurgery|Patients undergo 3 fractions of CyberKnife stereotactic radiosurgery.
902845|NCT01079806|B3|Baseline|Total|Total of all reporting groups
902846|NCT01079806|B2|Baseline|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902847|NCT01079806|B1|Baseline|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902848|NCT01079806|P2|Participant Flow|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902849|NCT01079806|P1|Participant Flow|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902850|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902851|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902852|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902853|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902854|NCT01079806|O2|Outcome|Placebo|Placebo: Tablets/Oral Solution, Oral, 0 mg, once daily, 48-96 weeks, depending on response
902855|NCT01079806|O1|Outcome|Entecavir|Entecavir: Tablets/Oral Solution, Oral, 0.015 mg/kg up to 0.5 mg, once daily, 96-144 weeks, depending on response
902856|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902857|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902858|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902859|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902860|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902861|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902862|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902863|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902864|NCT01079806|O2|Outcome|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902865|NCT01079806|O1|Outcome|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902866|NCT01079806|E2|Reported Event|Placebo|Participants received placebo, 0 mg, once daily, for 48 to 96 weeks, depending on response
902867|NCT01079806|E1|Reported Event|Entecavir|Participants received entecavir, 0.015 mg/kg up to 0.5 mg, once daily, for 96 to 144 weeks, depending on response
902868|NCT01079598|B1|Baseline|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
902869|NCT01079598|P1|Participant Flow|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
902870|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
902871|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
902872|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
902873|NCT01079598|O1|Outcome|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
902874|NCT01079598|E1|Reported Event|Treatment|RF ablation of incompetent perforator and tributary veins with ClosureRFS Stylet
902875|NCT01079299|B3|Baseline|Total|Total of all reporting groups
902876|NCT01079299|B2|Baseline|Standard Compression Alone|
902877|NCT01079299|B1|Baseline|IPC Plus Standard Compression|
902878|NCT01079299|P2|Participant Flow|Standard Compression Alone|
902879|NCT01079299|P1|Participant Flow|IPC Plus Standard Compression|
902880|NCT01079299|O2|Outcome|Standard Compression Alone|
902881|NCT01079299|O1|Outcome|IPC Plus Standard Compression|
902882|NCT01079299|E2|Reported Event|Standard Compression Alone|
902883|NCT01079299|E1|Reported Event|IPC Plus Standard Compression|
902884|NCT01079234|B4|Baseline|Total|Total of all reporting groups
902885|NCT01079234|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902886|NCT01079234|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
902887|NCT01079234|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
903138|NCT01078662|P1|Participant Flow|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
902888|NCT01079234|P4|Participant Flow|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
902889|NCT01079234|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902890|NCT01079234|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
902891|NCT01079234|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
902892|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
902893|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902894|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
902895|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902896|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
902897|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902898|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902899|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
902900|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
902901|NCT01079234|O2|Outcome|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
902902|NCT01079234|O1|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902903|NCT01079234|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902904|NCT01079234|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with the evening meal in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
902905|NCT01079234|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in main period. Insulin doses were individually adjusted by the subjects.
902906|NCT01079234|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling in combination with insulin aspart (IAsp) for 52 weeks (26 weeks in main period + 26 weeks in extension period). Insulin doses were individually adjusted by the subjects.
902907|NCT01079234|E1|Reported Event|IDeg OD F|The subjects randomised to the 2 insulin degludec (IDeg) treatment arms in the main period (IDeg OD FF and IDeg OD) were pooled into this IDeg OD Free Flex arm (IDeg OD F). IDeg was given once daily (OD) subcutaneously (s.c.) at any time of the day (approximately 8-40 hours intervals) in combination with insulin aspart (IAsp) for 26 weeks in the extension period (52 weeks in total). Insulin doses were individually adjusted by the subjects.
903139|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
917294|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
902908|NCT01079195|B1|Baseline|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
902909|NCT01079195|P1|Participant Flow|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
902910|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
902911|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
902912|NCT01079195|O1|Outcome|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
902913|NCT01079195|E1|Reported Event|Tarka Therapy|Tarka (trandolapril/verapamil hydrochloride) was to be prescribed in a routine manner according to the terms of local regulatory authorizations. Eligible participants had a high risk of developing diabetes mellitus and high blood pressure that was not controlled with a single medication. Participants were to be treated by secondary care specialists such as internal medicine specialists, nephrologists, and endocrinologists.
902914|NCT01079182|B1|Baseline|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902915|NCT01079182|P1|Participant Flow|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902916|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902917|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902918|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902919|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902920|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902921|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902922|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902923|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902924|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902925|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902926|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902927|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902928|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902929|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902930|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902931|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902932|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902933|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902934|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902935|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902936|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902937|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902938|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902939|NCT01079182|O1|Outcome|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902940|NCT01079182|E1|Reported Event|Ankylosing Spondylitis|Participants with ankylosing spondylitis
902941|NCT01079143|B5|Baseline|Total|Total of all reporting groups
902942|NCT01079143|B4|Baseline|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902943|NCT01079143|B3|Baseline|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902944|NCT01079143|B2|Baseline|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902945|NCT01079143|B1|Baseline|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902946|NCT01079143|P4|Participant Flow|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903140|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
902947|NCT01079143|P3|Participant Flow|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902948|NCT01079143|P2|Participant Flow|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902949|NCT01079143|P1|Participant Flow|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902950|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902951|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902952|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902953|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902954|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902955|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902956|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902957|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902958|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902959|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902960|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902961|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902962|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902963|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902964|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902965|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902966|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902967|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902968|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902969|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902970|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902971|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902972|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903141|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
902973|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902974|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902975|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902976|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902977|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902978|NCT01079143|O2|Outcome|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902979|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902980|NCT01079143|O2|Outcome|Neoral|Between transplantation adn randomization, all patients have received Neoral. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic.
902981|NCT01079143|O1|Outcome|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902982|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902983|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902984|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902985|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902986|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902987|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902988|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902989|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902990|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902991|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902992|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902993|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902994|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902995|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902996|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902997|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
902998|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
902999|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903000|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903001|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903002|NCT01079143|O2|Outcome|No- No Fibrosis Progression|Participants who did not experience fibrosis progression based on IF/TA (univariate analysis)
903003|NCT01079143|O1|Outcome|Yes- Fibrosis Progression|Participants who experienced fibrosis progression based on IF/TA (univariate analysis)
903004|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903005|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903006|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903007|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903008|NCT01079143|O4|Outcome|Neoral EMT-|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903009|NCT01079143|O3|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903010|NCT01079143|O2|Outcome|Certican EMT-|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903011|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903012|NCT01079143|O2|Outcome|Neoral EMT+|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903013|NCT01079143|O1|Outcome|Certican EMT+|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903014|NCT01079143|E2|Reported Event|Certican|Patients randomized to the Certican® treatment group started this treatment after randomization (which took place 3 to 4 months post-transplantation), preferably in the evening, otherwise the following morning. Patients in the Neoral® treatment group did not receive Certican®.
903015|NCT01079143|E1|Reported Event|Neoral|Between transplantation and randomization, all patients have received Neoral®. Treatment had to be initiated within 24 hours post-transplantation in combination with Myfortic®.
903016|NCT01079130|B7|Baseline|Total|Total of all reporting groups
903017|NCT01079130|B6|Baseline|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903018|NCT01079130|B5|Baseline|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903019|NCT01079130|B4|Baseline|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903020|NCT01079130|B3|Baseline|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903021|NCT01079130|B2|Baseline|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903022|NCT01079130|B1|Baseline|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
903023|NCT01079130|P6|Participant Flow|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903784|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903024|NCT01079130|P5|Participant Flow|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903025|NCT01079130|P4|Participant Flow|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903026|NCT01079130|P3|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903027|NCT01079130|P2|Participant Flow|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903028|NCT01079130|P1|Participant Flow|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
903029|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903030|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903031|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903032|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903033|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903034|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
903035|NCT01079130|O6|Outcome|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903036|NCT01079130|O5|Outcome|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903037|NCT01079130|O4|Outcome|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903038|NCT01079130|O3|Outcome|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903039|NCT01079130|O2|Outcome|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903040|NCT01079130|O1|Outcome|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
903142|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903041|NCT01079130|E6|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903042|NCT01079130|E5|Reported Event|Salmeterol|Salmeterol 50 µg twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) and Placebo to Indacaterol once daily in the morning via Concept1, a SDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903043|NCT01079130|E4|Reported Event|Indacaterol 150 µg|Indacaterol 150 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903044|NCT01079130|E3|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903045|NCT01079130|E2|Reported Event|Indacaterol 37.5 µg|Indacaterol 37.5 µg once daily in the morning via Concept1, a SDDPI and Placebo to Salmeterol in the morning and in the evening via Diskus®, a MDDPI for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
903046|NCT01079130|E1|Reported Event|Indacaterol 18.75 µg|Indacaterol 18.75 µg once daily in the morning via Concept1, a single-dose dry powder inhaler (SDDPI) and Placebo to Salmeterol in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI) for 2 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study
903047|NCT01078974|B1|Baseline|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
903048|NCT01078974|P1|Participant Flow|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
903049|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
903050|NCT01078974|O1|Outcome|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
903051|NCT01078974|E1|Reported Event|Pomalidomide, Dexamethasone, Rituximab|"Drug: pomalidomide Taken orally once a day~Drug: dexamethasone Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~Drug: rituximab Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~pomalidomide: Taken orally once a day~dexamethasone: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15~rituximab: Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15"
903052|NCT01078922|B1|Baseline|Ofatumumab|The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
903053|NCT01078922|P1|Participant Flow|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
903054|NCT01078922|O1|Outcome|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
903055|NCT01078922|O1|Outcome|Ofatumumab|Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
903143|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903144|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
903145|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
903056|NCT01078922|E1|Reported Event|Ofatumumab|"The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.~Ofatumumab: The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours."
903057|NCT01078909|B6|Baseline|Total|Total of all reporting groups
903058|NCT01078909|B5|Baseline|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
903059|NCT01078909|B4|Baseline|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
903060|NCT01078909|B3|Baseline|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 65 month supplementation period
903061|NCT01078909|B2|Baseline|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
903062|NCT01078909|B1|Baseline|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 5 month supplementation period
903063|NCT01078909|P5|Participant Flow|Placebo|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
903064|NCT01078909|P4|Participant Flow|1800mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
903065|NCT01078909|P3|Participant Flow|900mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
903066|NCT01078909|P2|Participant Flow|600mg Fish Oil (EPA+DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
903067|NCT01078909|P1|Participant Flow|300mg Fish Oil (EPA + DHA) Supplement|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA) following a 6 month supplementation period
903068|NCT01078909|O5|Outcome|Placebo|
903069|NCT01078909|O4|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
903070|NCT01078909|O3|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
903071|NCT01078909|O2|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
903072|NCT01078909|O1|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
903073|NCT01078909|O5|Outcome|Placebo|
903074|NCT01078909|O4|Outcome|1800mg Fish Oil (EPA + DHA) Supplement|
903075|NCT01078909|O3|Outcome|900mg Fish Oil (EPA + DHA) Supplement|
903076|NCT01078909|O2|Outcome|600mg Fish Oil (EPA+DHA) Supplement|
903077|NCT01078909|O1|Outcome|300mg Fish Oil (EPA + DHA) Supplement|
903078|NCT01078909|E5|Reported Event|0 mg/d EPA + DHA (Placebo)|
903079|NCT01078909|E4|Reported Event|1800 mg/d EPA + DHA (Fish Oil) Supplement|
903080|NCT01078909|E3|Reported Event|900 mg/d EPA + DHA (Fish Oil) Supplement|
903081|NCT01078909|E2|Reported Event|600 mg/d EPA + DHA (Fish Oil) Supplement|
903082|NCT01078909|E1|Reported Event|300 mg/d EPA + DHA (Fish Oil) Supplement|
903083|NCT01078805|B1|Baseline|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903084|NCT01078805|P1|Participant Flow|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903085|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903086|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903087|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903088|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903089|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903090|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903091|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903092|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903093|NCT01078805|O1|Outcome|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903094|NCT01078805|E1|Reported Event|FORTEO (Teriparatide)-Treated|FORTEO: prescribed in accordance with usual clinical practice for up to 24 months
903095|NCT01078753|B3|Baseline|Total|Total of all reporting groups
903096|NCT01078753|B2|Baseline|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
903097|NCT01078753|B1|Baseline|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
903098|NCT01078753|P2|Participant Flow|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
903146|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
903147|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
903148|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903099|NCT01078753|P1|Participant Flow|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
903100|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
903101|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
903102|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
903103|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
903104|NCT01078753|O2|Outcome|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
903105|NCT01078753|O1|Outcome|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
903106|NCT01078753|E2|Reported Event|Placebo|Participants received matching placebo tablets during treatment periods I and II according to the same efficacy criteria as participants in the Desmopressin treatment group.
903107|NCT01078753|E1|Reported Event|Desmopressin|During treatment period I participants received 120 μg per day desmopressin oral lyophilisate tablet for 14 days. Participants for whom treatment was effective (a reduction of ≥ 75% from Baseline in the number of wet nights), and who showed no problems with tolerability, continued to receive the same treatment for a further 14 days in treatment period II. Participants for whom efficacy was inadequate (a reduction of <75% from Baseline in the number of wet nights), but who showed no tolerability problems, received an increased dose of desmopressin oral lyophilisate tablet 240 µg for 14 days in treatment period II.
903108|NCT01078675|B3|Baseline|Total|Total of all reporting groups
903109|NCT01078675|B2|Baseline|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
903110|NCT01078675|B1|Baseline|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903111|NCT01078675|P2|Participant Flow|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
903112|NCT01078675|P1|Participant Flow|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903113|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903114|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
903115|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
903116|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903117|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903118|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903119|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903120|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903121|NCT01078675|O2|Outcome|Healthy Siblings|Controls to HeFH patients in the cIMT evaluations
903122|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903123|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903124|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 10 mg
903125|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903126|NCT01078675|O1|Outcome|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903127|NCT01078675|E1|Reported Event|Rosuvastatin|Rosuvastatin 5 mg, 10 mg or 20 mg
903128|NCT01078662|B6|Baseline|Total|Total of all reporting groups
903129|NCT01078662|B5|Baseline|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
903130|NCT01078662|B4|Baseline|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
903131|NCT01078662|B3|Baseline|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903132|NCT01078662|B2|Baseline|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903133|NCT01078662|B1|Baseline|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
903134|NCT01078662|P5|Participant Flow|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
903135|NCT01078662|P4|Participant Flow|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
903136|NCT01078662|P3|Participant Flow|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903137|NCT01078662|P2|Participant Flow|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903152|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903153|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903154|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
903155|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
903156|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903157|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903158|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
903159|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
903160|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903161|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903162|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
903163|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
903164|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
903165|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
903166|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903167|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903168|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
903169|NCT01078662|O6|Outcome|All Patients|Patients of different cancer types
903170|NCT01078662|O5|Outcome|Other Cancers|Patients with other primary cancers. Receiving olaparib 400mg BID
903171|NCT01078662|O4|Outcome|Prostate Cancer|Patients with primary cancer site = prostate. Receiving olaparib 400mg BID
903172|NCT01078662|O3|Outcome|Pancreatic Cancer|Patients with primary cancer site = pancreas. Receiving olaparib 400mg BID
903173|NCT01078662|O2|Outcome|Ovarian Cancer|Patients with primary cancer site = ovary. Receiving olaparib 400mg BID
903174|NCT01078662|O1|Outcome|Breast Cancer|Patients with primary cancer site = breast. Receiving olaparib 400mg BID
903175|NCT01078662|E1|Reported Event|OLAPARIB|
903176|NCT01078623|B1|Baseline|Overall Study Population|All patients randomized into the study
903177|NCT01078623|P20|Participant Flow|Sequence 20|Placebo - Formoterol 12 - Aclidinium 200 - FDC 200/12
903178|NCT01078623|P19|Participant Flow|Sequence 19|Formoterol 12 - Aclidinium 200 - FDC 200/12 - FDC 200/6
903179|NCT01078623|P18|Participant Flow|Sequence 18|Aclidinium 200 - FDC 200/12 - FDC 200/6 - Placebo
903180|NCT01078623|P17|Participant Flow|Sequence 17|FDC 200/12 - FDC 200/6 - Placebo - Formoterol 12
903181|NCT01078623|P16|Participant Flow|Sequence 16|FDC 200/6 - Placebo - Formoterol 12 - Aclidinium 200
903182|NCT01078623|P15|Participant Flow|Sequence 15|Placebo - Aclidinium 200 - FDC 200/6 - Formoterol 12
903183|NCT01078623|P14|Participant Flow|Sequence 14|Formoterol 12 - FDC 200/12 - Placebo - Aclidinium 200
903184|NCT01078623|P13|Participant Flow|Sequence 13|Aclidinium 200 - FDC 200/6 - Formoterol 12 - FDC 200/12
903185|NCT01078623|P12|Participant Flow|Sequence 12|FDC 200/12 - Placebo - Aclidinium 200 - FDC 200/6
903186|NCT01078623|P11|Participant Flow|Sequence 11|FDC 200/6 - Formoterol 12 - FDC 200/12 - Placebo
903187|NCT01078623|P10|Participant Flow|Sequence 10|Placebo - FDC 200/12 - Formoterol 12 - FDC 200/6
903188|NCT01078623|P9|Participant Flow|Sequence 9|Formoterol 12 - FDC 200/6 - Aclidinium 200 - Placebo
903189|NCT01078623|P8|Participant Flow|Sequence 8|Aclidinium 200 - Placebo - FDC 200/12 - Formoterol 12
903190|NCT01078623|P7|Participant Flow|Sequence 7|FDC 200/12 - Formoterol 12 - FDC 200/6 - Aclidinium 200
903191|NCT01078623|P6|Participant Flow|Sequence 6|FDC 200/6 - Aclidinium 200 - Placebo - FDC 200/12
903192|NCT01078623|P5|Participant Flow|Sequence 5|Placebo - FDC 200/6 - FDC 200/12 - Aclidinium 200
903193|NCT01078623|P4|Participant Flow|Sequence 4|Formoterol 12 - Placebo - FDC 200/6 - FDC 200/12
903194|NCT01078623|P3|Participant Flow|Sequence 3|Aclidinium 200 - Formoterol 12 - Placebo - FDC 200/6
903195|NCT01078623|P2|Participant Flow|Sequence 2|FDC 200/12 - Aclidinium 200 - Formoterol 12 - Placebo
903196|NCT01078623|P1|Participant Flow|Sequence 1|FDC 200/6 μg - FDC 200/12 μg - Aclidinium 200 μg - Formoterol 12 μg
903197|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
903198|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
903199|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
903200|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
903201|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
903202|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
903203|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
903204|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
903205|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
903206|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
903207|NCT01078623|O5|Outcome|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
903208|NCT01078623|O4|Outcome|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
903209|NCT01078623|O3|Outcome|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
903785|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903210|NCT01078623|O2|Outcome|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
903211|NCT01078623|O1|Outcome|Placebo|Placebo twice daily
903212|NCT01078623|E5|Reported Event|Formoterol 12 μg|Formoterol fumurate 12 μg twice daily
903213|NCT01078623|E4|Reported Event|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
903214|NCT01078623|E3|Reported Event|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumurate 6 μg fixed dose combination (FDC) twice daily
903215|NCT01078623|E2|Reported Event|Aclidinium 200 μg / Formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumurate 12 μg fixed dose combination (FDC) twice daily
903216|NCT01078623|E1|Reported Event|Placebo|Placebo twice daily
903217|NCT01078584|B1|Baseline|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903218|NCT01078584|P1|Participant Flow|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903219|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903220|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903221|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903222|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903223|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903224|NCT01078584|O2|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903225|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903226|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903227|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903228|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903229|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903230|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903231|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903302|NCT01078571|O2|Outcome|Adalimumab (Treatment for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
903378|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903232|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
903233|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
903234|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
903235|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
903236|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
903237|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
903238|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
903239|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
903240|NCT01078584|O4|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
903241|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
903242|NCT01078584|O2|Outcome|Non-Diabetic Cohort: BP-Controlled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-controlled if BP <140/90 mm Hg.
903243|NCT01078584|O1|Outcome|Non-Diabetic Cohort: BP-Uncontrolled|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Non-diabetics were considered to be BP-uncontrolled if BP >/=140/90 mm Hg.
903244|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903245|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903246|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903247|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903248|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903249|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903250|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903251|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903252|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903253|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903254|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903255|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903256|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903257|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903258|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903259|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903260|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903261|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903262|NCT01078584|O4|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903263|NCT01078584|O3|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903264|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903303|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
903265|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903266|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903267|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903268|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903269|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903270|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903271|NCT01078584|O1|Outcome|Renal Dysfunction Cohort|"The Renal Dysfunction cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a co-morbidity of renal dysfunction was recorded at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment."
903272|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903273|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903274|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903275|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903276|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903277|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903278|NCT01078584|O1|Outcome|Isolated Systolic Hypertension Cohort|The Isolated Systolic Hypertension (ISH) cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days who had a baseline systolic blood pressure >/=140 mm Hg and a baseline diastolic blood pressure <90 mm Hg. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903279|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903280|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903281|NCT01078584|O1|Outcome|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903376|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903282|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
903283|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
903284|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903285|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
903286|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
903287|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903288|NCT01078584|O3|Outcome|Diabetic Cohort: BP-Uncontrolled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-uncontrolled if BP >/=130/80 mm Hg.
903289|NCT01078584|O2|Outcome|Diabetic Cohort: BP-Controlled|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment. Diabetics were considered to be BP-controlled if BP <130/80 mm Hg.
903290|NCT01078584|O1|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903291|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903292|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903293|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903294|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903295|NCT01078584|O2|Outcome|Diabetic Cohort|The Diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903296|NCT01078584|O1|Outcome|Non-Diabetic Cohort|The Non-diabetic cohort includes all hypertensive participants who were either naïve to trandolapril or on trandolapril within past 30 days for whom a diagnosis of diabetes was not present at the Baseline visit. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903297|NCT01078584|E1|Reported Event|All Enrolled Participants (ITT Cohort)|Hypertensive participants (diabetics and non-diabetics, with or without isolated systemic hypertension and/or renal dysfunction) who were either naïve to trandolapril or on trandolapril within past 30 days. Trandolapril 0.5, 1.0, 2.0, or 4.0 mg, was prescribed as per usual care. Participants received at least one dose of trandolapril after enrollment.
903298|NCT01078571|B1|Baseline|Adalimumab (Humira)|
903299|NCT01078571|P1|Participant Flow|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
903300|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months|Participants who had been taking adalimumab for 4 months or longer.
903301|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time four months or less before the baseline visit were classified as de novo participants."
903304|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
903305|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
903306|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
903307|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
903308|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
903309|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
903310|NCT01078571|O2|Outcome|Adalimumab (Treated for Greater Than 4 Months)|Participants who had been taking adalimumab for 4 months or longer.
903311|NCT01078571|O1|Outcome|Adalimumab (De Novo)|"Those participants to whom adalimumab had been prescribed for the first time 4 months or less before the baseline visit were classified as de novo participants."
903312|NCT01078571|O1|Outcome|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
903313|NCT01078571|E1|Reported Event|Adalimumab Treatment|Participants with rheumatoid arthritis receiving treatment with adalimumab at 40 mg alternate weeks
903314|NCT01078545|B1|Baseline|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903315|NCT01078545|P1|Participant Flow|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903316|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903317|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903318|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903319|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903320|NCT01078545|O1|Outcome|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903321|NCT01078545|E1|Reported Event|Advanced PCa Patients With LUTS Treated With GnRH Analogue|Patients with advanced prostate cancer (PCa) and lower urinary tract symptoms (LUTS) treated with GnRH analogue Lucrin Depot 11.25 mg (Lucrin Depot 3.75mg - in Ukraine)
903322|NCT01078454|B3|Baseline|Total|Total of all reporting groups
903323|NCT01078454|B2|Baseline|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
903324|NCT01078454|B1|Baseline|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
903325|NCT01078454|P2|Participant Flow|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
903326|NCT01078454|P1|Participant Flow|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
903327|NCT01078454|O2|Outcome|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
903328|NCT01078454|O1|Outcome|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
903329|NCT01078454|E2|Reported Event|Arm B (B-Mel-Dex)|Patients receive melphalan 0.22 mg/kg PO and dexamethasone 40 mg PO on days 1-4 and bortezomib 1.3 mg/m^2 intravenously (IV) on days 1, 4, 8, and 11 every 4 weeks. Treatment repeats every 4 weeks for 2 cycles. Patients then receive melphalan PO and dexamethasone PO on days 1-4 and bortezomib IV on days 1, 8, 15, and 22 every 5 weeks. Treatment repeats every 5 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
903330|NCT01078454|E1|Reported Event|Arm A (Mel-Dex)|Patients receive melphalan 0.22 mg/kg orally (PO) and dexamethasone 40 mg PO on days 1-4 every 4 weeks. Treatment repeats every 4 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity.
903377|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
917295|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
903331|NCT01078441|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
903332|NCT01078441|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
903333|NCT01078441|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.~liposomal doxorubicin: Given IV~bortezomib: Given subcutaneously.~dexamethasone: Given orally~cyclophosphamide: Given IV"
903334|NCT01078441|E1|Reported Event|Combination Chemotherapy|Patients receive bortezomib subcutaneously on days 1, 8, and 15; liposomal doxorubicin intravenously (IV) over 1 hour on day 4; oral dexamethasone on days 1, 2, 8, 9, 15 and 16; and cyclophosphamide IV over 2 hours on day 1. Treatment repeats every 21 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity.
903335|NCT01078402|B4|Baseline|Total|Total of all reporting groups
903336|NCT01078402|B3|Baseline|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903337|NCT01078402|B2|Baseline|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903338|NCT01078402|B1|Baseline|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903339|NCT01078402|P3|Participant Flow|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903340|NCT01078402|P2|Participant Flow|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903341|NCT01078402|P1|Participant Flow|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903342|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
903343|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903344|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903345|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903346|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
903347|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903348|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903349|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903350|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
903351|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903352|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903353|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903354|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
903355|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903356|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903357|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903358|NCT01078402|O4|Outcome|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
903359|NCT01078402|O3|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903360|NCT01078402|O2|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903361|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903362|NCT01078402|O2|Outcome|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903363|NCT01078402|O1|Outcome|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903364|NCT01078402|O1|Outcome|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903365|NCT01078402|E4|Reported Event|All Participants (RA, PsA, AS)|Participants with active rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis
903366|NCT01078402|E3|Reported Event|Ankylosing Spondylitis (AS)|Participants with active ankylosing spondylitis
903367|NCT01078402|E2|Reported Event|Psoriatic Arthritis (PsA)|Participants with active psoriatic arthritis
903368|NCT01078402|E1|Reported Event|Rheumatoid Arthritis (RA)|Participants with active rheumatoid arthritis
903369|NCT01078389|B3|Baseline|Total|Total of all reporting groups
903370|NCT01078389|B2|Baseline|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903371|NCT01078389|B1|Baseline|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
903372|NCT01078389|P2|Participant Flow|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903373|NCT01078389|P1|Participant Flow|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
903374|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903375|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
903379|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
903380|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903381|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
903382|NCT01078389|O2|Outcome|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903383|NCT01078389|O1|Outcome|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
903384|NCT01078389|E2|Reported Event|Placebo|Febuxostat placebo-matching capsules, orally, once daily for up to 24 Months.
903385|NCT01078389|E1|Reported Event|Febuxostat 40 mg or 80 mg|Febuxostat 40 mg or 80 mg (based on serum urate levels at Day 14), capsules, orally, once daily for up to 24 Months.
903386|NCT01078376|B5|Baseline|Total|Total of all reporting groups
903387|NCT01078376|B4|Baseline|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903388|NCT01078376|B3|Baseline|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
903389|NCT01078376|B2|Baseline|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
903390|NCT01078376|B1|Baseline|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903391|NCT01078376|P4|Participant Flow|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903392|NCT01078376|P3|Participant Flow|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
903393|NCT01078376|P2|Participant Flow|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
903394|NCT01078376|P1|Participant Flow|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903395|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903396|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903397|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903398|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903399|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903400|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903401|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903402|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903403|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903404|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903405|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903406|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903407|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903408|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903409|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903410|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903411|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903412|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903413|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903414|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903415|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903416|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903417|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903418|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903419|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903420|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903421|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903422|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903786|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903423|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903424|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903425|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903426|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903427|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903428|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903429|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903430|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903431|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903432|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903433|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903434|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903435|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903436|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903437|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903438|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903439|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903440|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903441|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903442|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903443|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903444|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903445|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903446|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903447|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903448|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903449|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903450|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903451|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903452|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903453|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903454|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903455|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903456|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903457|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903458|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903459|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903460|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903461|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903462|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903463|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903464|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903465|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903466|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903467|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903468|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903469|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903470|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
917296|NCT01037244|O4|Outcome|Placebo|Placebo tablets
903471|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903472|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903473|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903474|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903475|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903476|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903477|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903478|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903479|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903480|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903481|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903482|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903483|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903484|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903485|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903486|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903487|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903488|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903489|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903490|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903491|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903492|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903493|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903494|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903495|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903496|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903497|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903498|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903499|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903500|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903501|NCT01078376|O7|Outcome|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903502|NCT01078376|O6|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 20 mg|Azilsartan medoxomil 20 mg, tablets, orally, one day only
903503|NCT01078376|O5|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903504|NCT01078376|O4|Outcome|Cohort 2: Children (≥6 to <12 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903505|NCT01078376|O3|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 40 mg|Azilsartan medoxomil 40 mg, tablets, orally, one day only
903506|NCT01078376|O2|Outcome|Cohort 1: Adolescents (≥12 to <17 Years Old) 60 mg|Azilsartan medoxomil 60 mg, tablets, orally, one day only
903507|NCT01078376|O1|Outcome|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903508|NCT01078376|E4|Reported Event|Cohort 3: Children (≥1 to <6 Years Old)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
903509|NCT01078376|E3|Reported Event|Cohort 2: Children (≥6 to <12 Years Old) 20-60 mg|Azilsartan medoxomil 20-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 20 to < 40 kg received a 20 mg dose, participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
903510|NCT01078376|E2|Reported Event|Cohort 1: Adolescents (≥12 to <17 Years Old) 40-60 mg|Azilsartan medoxomil 40-60 mg, tablets, orally, one day only. Dose regimen was based on body weight. Participants 40 to < 80 kg received a 40 mg dose and participants 80 to 100 kg received a 60 mg dose.
903511|NCT01078376|E1|Reported Event|Cohort 1: Healthy Adults|Azilsartan medoxomil 80 mg, tablets, orally, one day only
903512|NCT01078363|B3|Baseline|Total|Total of all reporting groups
903513|NCT01078363|B2|Baseline|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903514|NCT01078363|B1|Baseline|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903787|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903515|NCT01078363|P2|Participant Flow|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903516|NCT01078363|P1|Participant Flow|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903517|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903518|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903519|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903520|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903521|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903522|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903523|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~Placebo: Use of a placebo post heart Transplant for Blood pressure control."
903524|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril: Use of a ACE ( angiotension converting enzyme) inhibitors post heart Transplant for Blood pressure control."
903525|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903526|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903527|NCT01078363|O2|Outcome|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903528|NCT01078363|O1|Outcome|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903529|NCT01078363|E2|Reported Event|Placebo|"Sugar pill manufactured to mimic ramipril 5mg starting dose , increasing to 20mg daily for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903530|NCT01078363|E1|Reported Event|Ramipril|"ramipril, 5mg starting dose to maximum dose of 20mg daily dose for one year.~ramipril or placebo: Use of a ACE ( angiotension converting enzyme) inhibitors versus placebo post heart Transplant for Blood pressure control."
903531|NCT01078298|B3|Baseline|Total|Total of all reporting groups
903532|NCT01078298|B2|Baseline|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903533|NCT01078298|B1|Baseline|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903534|NCT01078298|P2|Participant Flow|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903535|NCT01078298|P1|Participant Flow|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903536|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903537|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903538|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903539|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903666|NCT01078090|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903540|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903541|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903542|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903543|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903544|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903545|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903546|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903547|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903548|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903549|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903550|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903551|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903552|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903553|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903554|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903555|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903556|NCT01078298|O2|Outcome|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903557|NCT01078298|O1|Outcome|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903558|NCT01078298|E2|Reported Event|Placebo|Placebo matched to varenicline 0.5 mg tablet orally once daily up to Day 3 followed by placebo matched to varenicline 0.5 mg tablet orally twice daily up to Day 7 and then placebo matched to varenicline 1 mg tablet orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903559|NCT01078298|E1|Reported Event|Varenicline|Varenicline 0.5 milligram (mg) tablet given orally once daily up to Day 3 followed by varenicline 0.5 mg tablet orally twice daily up to Day 7 and then varenicline 1 mg tablet given orally twice daily up to Week 12. Participants were followed-up for additional 40 weeks post-treatment.
903560|NCT01078246|B8|Baseline|Total|Total of all reporting groups
903561|NCT01078246|B7|Baseline|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
903562|NCT01078246|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
903563|NCT01078246|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
903564|NCT01078246|B4|Baseline|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
903565|NCT01078246|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
903566|NCT01078246|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
903567|NCT01078246|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
903568|NCT01078246|P7|Participant Flow|Historical, Concurrent and Raltegravir Cohorts|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), 2) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 3) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to all three cohorts.
903569|NCT01078246|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received therapy with a new non-RAL antiretroviral therapy on or after 12 October 2007 (Concurrent Cohort), and 2) received RAL after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Concurrent and Raltegravir Cohorts only.
903570|NCT01078246|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Concurrent Cohort only.
903571|NCT01078246|P4|Participant Flow|Historical and Concurrent Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received therapy with a new non-RAL antiretroviral therapy after 12 October 2007 (Concurrent Cohort). These participants contributed data to the Historical and Concurrent Cohorts only.
903572|NCT01078246|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort). These participants contributed data to the Historical Cohort only.
903573|NCT01078246|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007 (Historical Cohort), and 2) received RAL on or after 12 October 2007 (Raltegravir Cohort). These participants contributed data to the Historical and Raltegravir Cohorts only.
903574|NCT01078246|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who received raltegravir (RAL) on or after 12 October 2007 (the market authorization date in the United States) (Raltegravir Cohort). These participants contributed data to the Raltegravir Cohort only.
903575|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903576|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903577|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903578|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903579|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903580|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903581|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903582|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903583|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903665|NCT01078116|E1|Reported Event|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
917297|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
903584|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903585|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903586|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903587|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903588|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903589|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903590|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903591|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903592|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903593|NCT01078246|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903594|NCT01078246|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903595|NCT01078246|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903596|NCT01078246|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who received therapy with a new non-RAL antiretroviral therapy after 12 October 2007. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort. Participants from the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903597|NCT01078246|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who received antiretroviral therapy (non-RAL) between 1 January 2005 and 11 October 2007. These participants were eligible for inclusion in the Concurrent and Raltegravir Cohorts.
903598|NCT01078246|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who received RAL on or after 12 October 2007. Participants from the Historical Cohort and the Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903599|NCT01078233|B7|Baseline|Total|Total of all reporting groups
903600|NCT01078233|B6|Baseline|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
903601|NCT01078233|B5|Baseline|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
903602|NCT01078233|B4|Baseline|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
903603|NCT01078233|B3|Baseline|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
903604|NCT01078233|B2|Baseline|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
903605|NCT01078233|B1|Baseline|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
903776|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903606|NCT01078233|P6|Participant Flow|Concurrent and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Concurrent Cohort and the Raltegravir Cohort.
903607|NCT01078233|P5|Participant Flow|Concurrent Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data only to the Concurrent Cohort.
903608|NCT01078233|P4|Participant Flow|Historical and Concurrent Cohorts|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007, had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. These participants contributed data to the Historical Cohort and the Concurrent Cohort.
903609|NCT01078233|P3|Participant Flow|Historical Cohort Only|Participants with HIV-1 infection who started a new antiretroviral drug as part of a cART regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Historical Cohort.
903610|NCT01078233|P2|Participant Flow|Historical and Raltegravir Cohorts Only|Participants with HIV-1 infection who 1) started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007 and had at least 1 month prospective follow-up in the Historical Cohort, and 2) started raltegravir on or after 21 December 2007 and had at least 1 month prospective follow-up in the Raltegravir Cohort. These participants contributed data to the Historical Cohort and the Raltegravir Cohort.
903611|NCT01078233|P1|Participant Flow|Raltegravir Cohort Only|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union). Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in this cohort. These participants contributed data only to the Raltegravir Cohort.
903612|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
903613|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
903614|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903615|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
903616|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
903617|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903618|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
903619|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
903620|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903621|NCT01078233|O3|Outcome|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
903622|NCT01078233|O2|Outcome|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
903623|NCT01078233|O1|Outcome|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903624|NCT01078233|E3|Reported Event|Concurrent Cohort|Participants with HIV-1 infection who started a new antiretroviral drug other than raltegravir as part of a cART regimen on or after 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Concurrent Cohort. Participants from the Historical Cohort were eligible for inclusion in the Concurrent Cohort.
903625|NCT01078233|E2|Reported Event|Historical Cohort|Participants with HIV-1 infection who started a new antiretroviral drug as part of a combination antiretroviral therapy (cART) regimen on or after 1 January 2006 and before 21 December 2007. Participants had no previous exposure to the new drug and had at least 1 month prospective follow-up in the Historical Cohort.
903626|NCT01078233|E1|Reported Event|Raltegravir Cohort|Participants with HIV-1 infection who started raltegravir on or after 21 December 2007 (the authorization date in the European Union) and had at least 1 month prospective follow-up in the Raltegravir Cohort. Participants from the Historical Cohort and Concurrent Cohort were eligible for inclusion in the Raltegravir Cohort.
903627|NCT01078220|B1|Baseline|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
903628|NCT01078220|P1|Participant Flow|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
903629|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
903630|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
903631|NCT01078220|O1|Outcome|Autoimmune Safety Population|Any female with at least 12 months of membership at a MCO prior to their first dose of Gardasil, in order to exclude pre-existing conditions prior to their first dose of Gardasil.
903632|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
903633|NCT01078220|O1|Outcome|Pregnancy Safety Population|Any female from the Any Dose Safety Population with suspected exposure to Gardasil during pregnancy.
903634|NCT01078220|O2|Outcome|3-Dose Safety Population|Any female who was 9-26 years old at first dose of Gardasil and who was a MCO member at each dose, and who had a minimum of 28 days between doses 1 and 2, and 12 weeks between doses 2 and 3, and who received all 3 doses of Gardasil within 12 months
903635|NCT01078220|O1|Outcome|Any Dose Safety Population|Any female who received any dose of Gardasil at a MCO between August 2006 and March 2008.
903636|NCT01078220|E1|Reported Event|Any Dose Safety Population|Any female who received any dose of Gardasil at a managed care organization (MCO) between August 2006 and March 2008.
903637|NCT01078207|B1|Baseline|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
903638|NCT01078207|P1|Participant Flow|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
903639|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
903640|NCT01078207|O1|Outcome|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
903641|NCT01078207|E1|Reported Event|Adult Surgical Patients At Risk for Obstructive Sleep Apnea|Observational study of adult patients at high risk for obstructive sleep apnea undergoing general surgery requiring analgesia with an expected over night stay. All patients were in this group.
903642|NCT01078155|B1|Baseline|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903643|NCT01078155|P1|Participant Flow|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-tumor necrosis factor (TNF) was taken prior to a participant’s enrollment in the study.
903644|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903645|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903646|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903777|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903647|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903648|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903649|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903650|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903651|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903652|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903653|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903654|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903655|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903656|NCT01078155|O1|Outcome|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903657|NCT01078155|E1|Reported Event|Participants With Active Rheumatoid Arthritis (RA)|Participants (women and men) with active early and long-standing RA according to American College of Rheumatology revised criteria from 1987 were prescribed adalimumab in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines. The decision to prescribe or not to prescribe an anti-TNF was taken prior to a participant’s enrollment in the study.
903658|NCT01078116|B1|Baseline|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
903659|NCT01078116|P1|Participant Flow|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
903660|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
903661|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
903662|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
903663|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
903664|NCT01078116|O1|Outcome|Adalimumab Treatment|Male or female participants with moderate to severe active rheumatoid arthritis treated with adalimumab according to the approved Summary of Product Characteristics (SmPC) in European Union
903667|NCT01078090|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903668|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
903669|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
903670|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
903671|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
903672|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
903673|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
903674|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
903675|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
903676|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
903677|NCT01078090|O1|Outcome|Month 0|Baseline
903678|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903679|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903680|NCT01078090|O5|Outcome|Month 30|30 months after inclusion
903681|NCT01078090|O4|Outcome|Month 24|24 months after inclusion
903682|NCT01078090|O3|Outcome|Month 18|18 months after inclusion
903683|NCT01078090|O2|Outcome|Month 6|6 months after inclusion
903684|NCT01078090|O1|Outcome|Month 0|Baseline
903685|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903686|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903687|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903688|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903689|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903690|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903691|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903692|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903693|NCT01078090|O10|Outcome|Month 60|60 months after inclusion
903694|NCT01078090|O9|Outcome|Month 48|48 months after inclusion
903695|NCT01078090|O8|Outcome|Month 36|36 months after inclusion
903696|NCT01078090|O7|Outcome|Month 30|30 months after inclusion
903697|NCT01078090|O6|Outcome|Month 24|24 months after inclusion
903698|NCT01078090|O5|Outcome|Month 18|18 months after inclusion
903699|NCT01078090|O4|Outcome|Month 12|12 months after inclusion
903700|NCT01078090|O3|Outcome|Month 6|6 months after inclusion
903701|NCT01078090|O2|Outcome|Month 3|3 months after inclusion
903702|NCT01078090|O1|Outcome|Month 0|Baseline
903703|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903704|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903705|NCT01078090|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903706|NCT01078090|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed from the first dose for up to 5 years.
903707|NCT01077973|B4|Baseline|Total|Total of all reporting groups
903708|NCT01077973|B3|Baseline|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903709|NCT01077973|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903710|NCT01077973|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903711|NCT01077973|P3|Participant Flow|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903712|NCT01077973|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903713|NCT01077973|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903714|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903715|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903778|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
917298|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
903716|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903717|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903718|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903719|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903720|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903721|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903722|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903723|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903724|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903725|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903726|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903727|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903728|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903729|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903730|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903731|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903732|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903733|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903734|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903735|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903736|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903737|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903738|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903739|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903740|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903741|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903742|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903743|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903744|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903745|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903779|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903746|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903747|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903748|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903749|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903750|NCT01077973|O3|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903751|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903752|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903753|NCT01077973|O2|Outcome|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903754|NCT01077973|O1|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903755|NCT01077973|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903756|NCT01077973|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903757|NCT01077973|E3|Reported Event|Ibuprofen (Motrin IB)|Single oral dose of 2 ibuprofen (Motrin IB) 200 mg tablets (total dose to 400 mg ibuprofen) along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903758|NCT01077973|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen along with single oral dose of 2 placebo tablets matched to ibuprofen (Motrin IB) 200 mg tablet.
903759|NCT01077973|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen [Motrin ibuprofen (IB)] 200 milligram (mg) tablet along with single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
903760|NCT01077960|B1|Baseline|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903761|NCT01077960|P1|Participant Flow|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903762|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903763|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903764|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903765|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903766|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903767|NCT01077960|O1|Outcome|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903768|NCT01077960|E1|Reported Event|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
903769|NCT01077921|B3|Baseline|Total|Total of all reporting groups
903770|NCT01077921|B2|Baseline|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period
903771|NCT01077921|B1|Baseline|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
903772|NCT01077921|P2|Participant Flow|Placebo-first|Cross-over study comprising treatment with placebo for 6 weeks, followed by a 2 weeks period washout, then similar treatment period with propranolol with a standard dose of 40 mg every 12 hrs., followed by another 2 weeks washout period.
903773|NCT01077921|P1|Participant Flow|Propranolol-first|Cross-over study comprising treatment with propranolol for 6 weeks with a standard dose of 40 mg every 12 hrs, followed by a 2 weeks period washout, then similar treatment period with placebo followed by another 2 weeks washout period
903774|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903775|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903790|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903791|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903792|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903793|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903794|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903795|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903796|NCT01077921|O2|Outcome|Placebo|All subjects completing placebo treatment phase.
903797|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903798|NCT01077921|O2|Outcome|Placebo|All subjects completing the placebo treatment phase.
903799|NCT01077921|O1|Outcome|Propranolol|All subjects completing the propranolol treatment phase.
903800|NCT01077921|E2|Reported Event|Placebo|Placebo: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
903801|NCT01077921|E1|Reported Event|Propranolol|Propranolol: Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
903802|NCT01077856|B4|Baseline|Total|Total of all reporting groups
903803|NCT01077856|B3|Baseline|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
903804|NCT01077856|B2|Baseline|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
903805|NCT01077856|B1|Baseline|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
903806|NCT01077856|P3|Participant Flow|Sweden Participants|Participants in Sweden who completed the first survey (before licensure of GARDASIL)
903807|NCT01077856|P2|Participant Flow|Norway Participants|Participants in Norway who completed the first survey (before licensure of GARDASIL)
903808|NCT01077856|P1|Participant Flow|Denmark Participants|Participants in Denmark who completed the first survey (before licensure of GARDASIL)
903809|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
903810|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
903811|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
903812|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
903813|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
903814|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
903815|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
903816|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
903817|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
903818|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
903819|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
903820|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
903821|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
903822|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
903823|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
903824|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
903825|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
903826|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
903827|NCT01077856|O6|Outcome|Sweden Participants Who Did Not Receive Gardasil|
903828|NCT01077856|O5|Outcome|Sweden Participants Who Received Gardasil|Sweden participants who received Gardasil on or before March 2012
903829|NCT01077856|O4|Outcome|Norway Participants Who Did Not Receive Gardasil|
903830|NCT01077856|O3|Outcome|Norway Participants Who Received Gardasil|Norway participants who received Gardasil on or before March 2012
903831|NCT01077856|O2|Outcome|Denmark Participants Who Did Not Receive Gardasil|
903832|NCT01077856|O1|Outcome|Denmark Participants Who Received Gardasil|Denmark participants who received Gardasil on or before March 2012
903833|NCT01077856|O6|Outcome|Babies Born to Sweden Participants|Live babies born between 2007 and 2011 to Sweden participants in the general population, including participants who did and did not received Gardasil
903834|NCT01077856|O5|Outcome|Babies Born to Sweden Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Sweden participants who received Gardasil during pregnancy
903835|NCT01077856|O4|Outcome|Babies Born to Norway Participants|Live babies born between 2007 and 2011 to Norway participants in the general population, including participants who did and did not receive Gardasil
903836|NCT01077856|O3|Outcome|Babies Born to Norway Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Norway participants who received Gardasil during pregnancy
903837|NCT01077856|O2|Outcome|Babies Born to Denmark Participants|Live babies born between 2007 and 2011 to Denmark participants in the general population, including participants who did and did not receive Gardasil
903838|NCT01077856|O1|Outcome|Babies Born to Denmark Participants Who Received Gardasil|Live babies born between 2007 and 2011 to Denmark participants who received Gardasil during pregnancy
903839|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903840|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903841|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903842|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903843|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903844|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903845|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903846|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903847|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903848|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903849|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903850|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903851|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903852|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903853|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903854|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903855|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903856|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903857|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903858|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903859|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903860|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903861|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903862|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903863|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903864|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903865|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903866|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903867|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903868|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903869|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903870|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903871|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903872|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903873|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903874|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903875|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903876|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903877|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903878|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903879|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903880|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903881|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903882|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903883|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903884|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903885|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903886|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903887|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903888|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903889|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903890|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903891|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903892|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903893|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903894|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903895|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903896|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903897|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903898|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903899|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903900|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903901|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903902|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903903|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903904|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903905|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903906|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903907|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903908|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903909|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903910|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903911|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903912|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903913|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903914|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903915|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903916|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903917|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903918|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903919|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903920|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903921|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903922|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903923|NCT01077856|O6|Outcome|Sweden Participants 2011 to 2012 After Gardasil Licensure|
903924|NCT01077856|O5|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903925|NCT01077856|O4|Outcome|Norway Participants 2011 to 2012 After Gardasil Licensure|
903926|NCT01077856|O3|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903927|NCT01077856|O2|Outcome|Denmark Participants 2011 to 2012 After Gardasil Licensure|
903928|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903929|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
903930|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
903931|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
903932|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
903933|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
903934|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903935|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
903936|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
903937|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
903938|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
903939|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
903940|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903941|NCT01077856|O6|Outcome|Sweden Participants 2011 After Gardasil Licensure|
903942|NCT01077856|O5|Outcome|Sweden Participants 2010 After Gardasil Licensure|
903943|NCT01077856|O4|Outcome|Sweden Participants 2009 After Gardasil Licensure|
903944|NCT01077856|O3|Outcome|Sweden Participants 2008 After Gardasil Licensure|
903945|NCT01077856|O2|Outcome|Sweden Participants 2007, After Gardasil Licensure|
903946|NCT01077856|O1|Outcome|Sweden Participants 2004 to 2006 Before Gardasil Licensure|
903947|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
903948|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
903949|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
903950|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
903951|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
903952|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903953|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
903954|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
903955|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
903956|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
903957|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
903958|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903959|NCT01077856|O6|Outcome|Norway Participants 2011 After Gardasil Licensure|
903960|NCT01077856|O5|Outcome|Norway Participants 2010 After Gardasil Licensure|
903961|NCT01077856|O4|Outcome|Norway Participants 2009 After Gardasil Licensure|
903962|NCT01077856|O3|Outcome|Norway Participants 2008 After Gardasil Licensure|
903963|NCT01077856|O2|Outcome|Norway Participants 2007, After Gardasil Licensure|
903964|NCT01077856|O1|Outcome|Norway Participants 2004 to 2006 Before Gardasil Licensure|
903965|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
903966|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
903967|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
903968|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
903969|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
903970|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903971|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
903972|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
903973|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
903974|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
903975|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
903976|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903977|NCT01077856|O6|Outcome|Denmark Participants 2011 After Gardasil Licensure|
903978|NCT01077856|O5|Outcome|Denmark Participants 2010 After Gardasil Licensure|
903979|NCT01077856|O4|Outcome|Denmark Participants 2009 After Gardasil Licensure|
903980|NCT01077856|O3|Outcome|Denmark Participants 2008 After Gardasil Licensure|
903981|NCT01077856|O2|Outcome|Denmark Participants 2007, After Gardasil Licensure|
903982|NCT01077856|O1|Outcome|Denmark Participants 2004 to 2006 Before Gardasil Licensure|
903983|NCT01077856|E3|Reported Event|Sweden Participants|All Sweden study participants
903984|NCT01077856|E2|Reported Event|Norway Participants|All Norway study participants
903985|NCT01077856|E1|Reported Event|Denmark Participants|All Denmark study participants
903986|NCT01077830|B3|Baseline|Total|Total of all reporting groups
903987|NCT01077830|B2|Baseline|Placebo|Participants who received placebo in the base study
903988|NCT01077830|B1|Baseline|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
903989|NCT01077830|P2|Participant Flow|Placebo|Participantss who received placebo in the base study
903990|NCT01077830|P1|Participant Flow|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
903991|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
903992|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
903993|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
903994|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
903995|NCT01077830|O2|Outcome|Placebo|Participants who received placebo in the base study
903996|NCT01077830|O1|Outcome|Ezetimibe/Simvastatin 10/40 mg|Participants who received Ezetimibe/Simvastatin 10/40 mg in the base study
903997|NCT01077830|E2|Reported Event|Placebo|Participants who were assigned to the placebo cohort in the base study
903998|NCT01077830|E1|Reported Event|Ezetimibe/Simvastatin 10/40 mg|Participants who were assigned to the Ezetimibe/Simvastatin 10/40 mg cohort in the base study
903999|NCT01077817|B1|Baseline|Overall Study Population|
904000|NCT01077817|P1|Participant Flow|Overall Study Population|
904001|NCT01077817|O6|Outcome|Raloxifene|Participants who initiated osteoporosis treatment with raloxifene
904002|NCT01077817|O5|Outcome|Risendronate|Participants who initiated osteoporosis treatment with risedronate
904003|NCT01077817|O4|Outcome|Ibandronate|Participants who initiated osteoporosis treatment with ibandronate
904004|NCT01077817|O3|Outcome|Etidronate|Participants who initiated osteoporosis treatment with etidronate
904005|NCT01077817|O2|Outcome|Alendronate|Participants who initiated osteoporosis treatment with alendronate
904006|NCT01077817|O1|Outcome|Comparators|Participants who did not initiate osteoporosis treatment with a study drug
904007|NCT01077817|O2|Outcome|Comparison Sample (Case Cohort)|Participants who were matched to cases by age and membership in the GPRD on the case's onset date, and had not experienced any form of esophageal cancer or Paget's Disease and had not received oral or intravenous steroids or chemotherapy or radiotherapy, as indicated by GPRD codes.
904008|NCT01077817|O1|Outcome|Esophageal Cancer Cohort|Participants with any GPRD Medical Code for esophageal cancer (cases).
904009|NCT01077817|E1|Reported Event|Overall Study Population|
904010|NCT01077804|B1|Baseline|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
904011|NCT01077804|P1|Participant Flow|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
904012|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
904013|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
904014|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
904015|NCT01077804|O1|Outcome|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
904016|NCT01077804|E1|Reported Event|Varivax Vaccinated Children|Children who are members of Kaiser Permanente Medical Care Program (KPMCP) and who received a first dose (0.5 mL) of the varicella vaccine, Varivax, in 1995 between the ages of 12 and 23 months.
904017|NCT01077739|B3|Baseline|Total|Total of all reporting groups
904018|NCT01077739|B2|Baseline|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
904019|NCT01077739|B1|Baseline|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
904020|NCT01077739|P2|Participant Flow|Bevacizumab + 5-fluorouracil/Oxaliplatin/Leucovorin (FOLFOX)|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-fluorouracil [5-FU] plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
904021|NCT01077739|P1|Participant Flow|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1; oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1; and capecitabine 1000 mg/m^2, orally (PO), twice daily (BID) on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
917299|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
904398|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904022|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
904023|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
904024|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
904025|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
904026|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
904027|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
904028|NCT01077739|O2|Outcome|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
904029|NCT01077739|O1|Outcome|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
904030|NCT01077739|E2|Reported Event|Bevacizumab + FOLFOX|Participants received bevacizumab 5.0 mg/kg IV on Day 1 and FOLFOX (5-FU plus leucovorin and oxaliplatin) administered on Days 1 and 2 (followed by a rest period on Days 3 through 14); the specific FOLFOX regimen was determined on an individual participant basis by the investigator (5-FU and leucovorin dose was dependent on choice of FOLFOX regimen; oxaliplatin was administered at a dose ranging from 85 to 130 mg/m^2 IV on Day 1 based on choice of FOLFOX regimen). The cycle was repeated every 2 weeks until disease progression.
904031|NCT01077739|E1|Reported Event|Bevacizumab + Oxaliplatin + Capecitabine|Participants received bevacizumab 7.5 mg/kg IV on Day 1; oxaliplatin 130 mg/m^2 IV on Day 1; and capecitabine 1000 mg/m^2, PO, BID on Days 1 through 14 (followed by 1-week rest period). The cycle was repeated every 3 weeks until disease progression.
904032|NCT01077713|B3|Baseline|Total|Total of all reporting groups
904033|NCT01077713|B2|Baseline|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904034|NCT01077713|B1|Baseline|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904035|NCT01077713|P2|Participant Flow|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904036|NCT01077713|P1|Participant Flow|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 and gemcitabine 1200 milligrams per square meter (mg/m^2) IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904037|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904038|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904129|NCT01077596|P1|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
917300|NCT01037244|O4|Outcome|Placebo|Placebo tablets
904039|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904040|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904041|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904042|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904043|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904044|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904045|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904046|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904047|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904048|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904049|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904050|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904051|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904052|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904053|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904054|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904055|NCT01077713|O2|Outcome|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904130|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
904056|NCT01077713|O1|Outcome|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904057|NCT01077713|E2|Reported Event|Bevacizumab + Gemcitabine + Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion and cisplatin 60 mg/m^2 IV infusion on Day 1 and gemcitabine 1000 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21 day cycle until progressive disease, death, or intolerable toxicity.
904058|NCT01077713|E1|Reported Event|Bevacizumab + Gemcitabine|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 and gemcitabine 1200 mg/m^2 IV infusion on Days 1 and 8 of each 21-day cycle for a maximum of 6 cycles. After Cycle 6, participants continued treatment with bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 21-day cycle until progressive disease, death, or intolerable toxicity.
904059|NCT01077622|B1|Baseline|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904060|NCT01077622|P1|Participant Flow|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904061|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904062|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904063|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904064|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904065|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904066|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904067|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904068|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904069|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904070|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904071|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904072|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904073|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904074|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904075|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904076|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904077|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904078|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904079|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904080|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904081|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904082|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904083|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904084|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904085|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904086|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904087|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904088|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904089|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904090|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904091|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904092|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904093|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904094|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904095|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904096|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904097|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904131|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
917301|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
904098|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904099|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904100|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904101|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904102|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904103|NCT01077622|O1|Outcome|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904104|NCT01077622|E1|Reported Event|Ofatumumab|Participants received intravenous ofatumumab at an initial dose of 300 milligrams (mg). One week after the initial dose, participants received 7 infusions of 2000 mg at weekly intervals. Five weeks after the last 2000 mg infusion, participants received 4 infusions of 2000 mg at 4-week intervals.
904105|NCT01077596|B13|Baseline|Total|Total of all reporting groups
904106|NCT01077596|B12|Baseline|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
904107|NCT01077596|B11|Baseline|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
904108|NCT01077596|B10|Baseline|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
904109|NCT01077596|B9|Baseline|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
904110|NCT01077596|B8|Baseline|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
904111|NCT01077596|B7|Baseline|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
904112|NCT01077596|B6|Baseline|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
904113|NCT01077596|B5|Baseline|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
904114|NCT01077596|B4|Baseline|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
904115|NCT01077596|B3|Baseline|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
904116|NCT01077596|B2|Baseline|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
904117|NCT01077596|B1|Baseline|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
904118|NCT01077596|P12|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
904119|NCT01077596|P11|Participant Flow|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
904120|NCT01077596|P10|Participant Flow|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
904121|NCT01077596|P9|Participant Flow|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
904122|NCT01077596|P8|Participant Flow|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
904123|NCT01077596|P7|Participant Flow|Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
904124|NCT01077596|P6|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
904125|NCT01077596|P5|Participant Flow|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
904126|NCT01077596|P4|Participant Flow|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
904127|NCT01077596|P3|Participant Flow|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
904128|NCT01077596|P2|Participant Flow|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
904132|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
904133|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
904134|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
904135|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
904136|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
904137|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
904138|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
904139|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
904140|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
904141|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
904142|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
904143|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
904144|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
904145|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
904146|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
904147|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
904148|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
904149|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
904150|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
904151|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
904152|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
904153|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
904154|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
904155|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular ‘other’ antidepressant use was defined as use other antidepressant aside from Bupropion, TCA and SSRI for 4 times per week for 3 months at least 12 months before index date
904156|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
904157|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of tricyclic antidepressant for 4 times per week for 3 months at least 12 months before index date
904158|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
904159|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
904160|NCT01077596|O5|Outcome|Other Antidepressants, Regular Use|Regular “other” antidepressant use was defined as use other antidepressant aside from Bupropion, TCA, and SSRI for 4 times per week for 3 months at least 12 months before index date
904161|NCT01077596|O4|Outcome|Selective Serotonin Reuptake Inhibitors (SSRI), Regular Use|Regular SSRI use was defined as use of SSRI antidepressant for 4 times per week for 3 months at least 12 months before index date
904162|NCT01077596|O3|Outcome|Tricyclic Antidepressants (TCA), Regular Use|Regular TCA use was defined as use of TCA for 4 times per week for 3 months at least 12 months before index date
904163|NCT01077596|O2|Outcome|All Non-bupropion Antidepressants, Regular Use|Regular antidepressant use of non-bupropion was defined as use of non-bupropion antidepressant for 4 times per week for 3 months at least 12 months before index date
904164|NCT01077596|O1|Outcome|Bupropion, Regular Use|Regular Bupropion use was defined as 4 times per week for 3 months at least 12 months before index date
904165|NCT01077596|E12|Reported Event|New Antidepressant Exposure in Prostate Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Controls
904166|NCT01077596|E11|Reported Event|New Antidepressant Exposure in Prostate Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Prostate Cancer: Cases
904167|NCT01077596|E10|Reported Event|New Antidepressant Exposure in Breast Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Controls
904168|NCT01077596|E9|Reported Event|New Antidepressant Exposure in Breast Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Breast Cancer: Cases
904169|NCT01077596|E8|Reported Event|New Antidepressant Exposure in Uterine Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Controls
904170|NCT01077596|E7|Reported Event|New Antidepressant Exposure in Uterine Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Uterine Cancer: Cases
904171|NCT01077596|E6|Reported Event|New Antidepressant Exposure in Bladder Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Controls
904172|NCT01077596|E5|Reported Event|New Antidepressant Exposure in Bladder Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Bladder Cancer: Cases
904173|NCT01077596|E4|Reported Event|New Antidepressant Exposure in Lung Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Controls
904174|NCT01077596|E3|Reported Event|New Antidepressant Exposure in Lung Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Lung Cancer: Cases
904175|NCT01077596|E2|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Controls|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Controls
904176|NCT01077596|E1|Reported Event|New Antidepressant Exposure in Colorectal Cancer: Cases|New Antidepressant Exposure (defined as no antidepressant exposure within previous 6 months) in Colorectal Cancer: Cases
904177|NCT01077544|B3|Baseline|Total|Total of all reporting groups
904178|NCT01077544|B2|Baseline|Group 2|>= 10 years to <18 years pediatric patients
904179|NCT01077544|B1|Baseline|Group 1|1 year to < 10 years pediatric patients
904180|NCT01077544|P2|Participant Flow|Group 2|>= 10 years to <18 years pediatric patients
904181|NCT01077544|P1|Participant Flow|Group 1|1 year to < 10 years pediatric patients
904182|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904183|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904184|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904185|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904186|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904187|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904188|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904189|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904190|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904191|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904192|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904193|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904194|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904195|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904196|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904197|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904198|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904199|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904200|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904201|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904202|NCT01077544|O2|Outcome|Group 2|>= 10 years to <18 years pediatric patients
904203|NCT01077544|O1|Outcome|Group 1|1 year to < 10 years pediatric patients
904204|NCT01077544|E2|Reported Event|Group 2|>= 10 years to <18 years pediatric patients
904205|NCT01077544|E1|Reported Event|Group 1|1 year to < 10 years pediatric patients
904206|NCT01077401|B3|Baseline|Total|Total of all reporting groups
904207|NCT01077401|B2|Baseline|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
904208|NCT01077401|B1|Baseline|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
904209|NCT01077401|P2|Participant Flow|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
904210|NCT01077401|P1|Participant Flow|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
904352|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904211|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
904212|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
904213|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
904214|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
904215|NCT01077401|O2|Outcome|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
904216|NCT01077401|O1|Outcome|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
904217|NCT01077401|E2|Reported Event|Ranibizumab 2.0 mg|"Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.~ranibizumab: Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria."
904218|NCT01077401|E1|Reported Event|Ranibizumab 0.5mg|"Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.~Ranibizumab: Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria."
904219|NCT01077375|B3|Baseline|Total|Total of all reporting groups
904220|NCT01077375|B2|Baseline|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 md/day, twice a day in divided doses, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population."
904221|NCT01077375|B1|Baseline|Placebo|Double-blind Safety Population: Placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
904222|NCT01077375|P2|Participant Flow|Milnacipran|Randomized Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day in divided doses, oral administration.
904223|NCT01077375|P1|Participant Flow|Placebo|Randomized Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
904224|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)"
904225|NCT01077375|O1|Outcome|Placebo|Intent-to-treat Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
904226|NCT01077375|O2|Outcome|Milnacipran|"Intent-to-treat Population, milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
904227|NCT01077375|O1|Outcome|Placebo|Intent-to-treat (ITT) Population, placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
904228|NCT01077375|E2|Reported Event|Milnacipran|"Double-blind Safety Population: milnacipran treatment assignment, 100 to 200 mg/day, twice a day, oral administration.~One patient randomized to the milnacipran treatment group did not take at least one dose of double-blind study drug and was therefore not included in the Double-blind Safety Population.~Flexible dosing from 50 mg/day to 200 mg/day was allowed except at a) the initial dosage after randomization had to be 100 mg/day, b) the dose range during week 1 of the randomized double-blind treatment period was 50 to 100 mg/day, and c) patients had to be on at least 100 mg/day at Visit 3 (Week 5)."
904229|NCT01077375|E1|Reported Event|Placebo|Double-blind Safety Population: placebo treatment assignment, dose-matched placebo tablets, twice a day, oral administration.
904230|NCT01077362|B4|Baseline|Total|Total of all reporting groups
904231|NCT01077362|B3|Baseline|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904232|NCT01077362|B2|Baseline|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904353|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904233|NCT01077362|B1|Baseline|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904234|NCT01077362|P3|Participant Flow|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904235|NCT01077362|P2|Participant Flow|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904236|NCT01077362|P1|Participant Flow|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904237|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
904238|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904239|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904240|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904241|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
904242|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904243|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904244|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904245|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
904246|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904247|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904248|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904249|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
904250|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904251|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904274|NCT01077323|P1|Participant Flow|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
904252|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904253|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
904254|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904255|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904256|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904257|NCT01077362|O4|Outcome|All Ustekinumab Combined|Participants who received SC injections of ustekinumab at any dose (45 mg and 90 mg) through Week 40.
904258|NCT01077362|O3|Outcome|Ustekinumab 90 mg|Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, the same dosage schedule continued. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904259|NCT01077362|O2|Outcome|Ustekinumab 45 mg|Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 40. Participants received SC injections of placebo at Weeks 20 and 24 to maintain the blind.
904260|NCT01077362|O1|Outcome|Placebo|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive SC injections of ustekinumab 45 mg at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 40. If early escape, SC injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 40. For participants entering early escape, a SC placebo injection was given at Week 24 to maintain the blind.
904261|NCT01077362|E7|Reported Event|Ustekinumab 90 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
904262|NCT01077362|E6|Reported Event|Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred during Weeks 16-60 in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
904263|NCT01077362|E5|Reported Event|Placebo -> Ustekinumab 45 mg: Weeks 16-60|Adverse events which occurred (1) during Weeks 16-60 in participants randomly assigned to placebo at Baseline and who early escaped to ustekinumab 45 mg at Week 16 and (2) during Weeks 24-60 in participants randomly assigned to placebo at Baseline and who crossed over to ustekinumab 45 mg at Week 24.
904264|NCT01077362|E4|Reported Event|Placebo: Weeks 16-24|Adverse events which occurred during Weeks 16-24 in participants who were randomly assigned to placebo at Baseline and did not early escape at Week 16.
904265|NCT01077362|E3|Reported Event|Ustekinumab 90 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 90 mg at Baseline.
904266|NCT01077362|E2|Reported Event|Ustekinumab 45 mg: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to ustekinumab 45 mg at Baseline.
904267|NCT01077362|E1|Reported Event|Placebo: Controlled Period|Adverse events which occurred during Weeks 0-16 (placebo-controlled period) in participants who were randomly assigned to placebo at Baseline.
904268|NCT01077323|B4|Baseline|Total|Total of all reporting groups
904269|NCT01077323|B3|Baseline|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
904270|NCT01077323|B2|Baseline|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
904271|NCT01077323|B1|Baseline|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
904272|NCT01077323|P3|Participant Flow|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
904273|NCT01077323|P2|Participant Flow|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
904275|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
904276|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
904277|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
904278|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
904279|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
904280|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
904281|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
904282|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
904283|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
904284|NCT01077323|O3|Outcome|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
904285|NCT01077323|O2|Outcome|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
904286|NCT01077323|O1|Outcome|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
904287|NCT01077323|E3|Reported Event|Non-Diabetes Cohort|The Non-Diabetes Cohort was composed of persons who had 9 months of continuous enrollment in the underlying health insurance program prior to their assigned index dates and no claims associated with a diagnosis of diabetes, no dispensing of a diabetes drug, and no diagnosis of pancreatic disease in the baseline period.
904288|NCT01077323|E2|Reported Event|Other Antidiabetic Drug (OADs) Initiators|Initiators of other antidiabetic medications were persons with a pharmacy claim associated with a dispensing of one of the following drugs preceded by 9 months of continuous enrollment in the underlying health insurance program without a dispensing of the same medication: sulfonylureas (e.g. glyburide); metformin; TZDs (e.g. rosiglitazone); insulins (e.g. insulin glargine); sitagliptin; pramlintide; non-sulfonylurea secretagogues (e.g. repaglinide); α-glucosidase inhibitors (e.g. miglitol).
904289|NCT01077323|E1|Reported Event|Exenatide Initiators|Exenatide initiators were persons with a pharmacy claim associated with a dispensing of exenatide preceded by 9 months of continuous enrollment in the underlying health insurance plan without an exenatide dispensing. Patients eligible for both the exenatide cohort and the other antidiabetic drug medication cohort were preferentially entered into the former.
904290|NCT01077310|B3|Baseline|Total|Total of all reporting groups
904291|NCT01077310|B2|Baseline|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904351|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
904292|NCT01077310|B1|Baseline|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904293|NCT01077310|P2|Participant Flow|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904294|NCT01077310|P1|Participant Flow|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904295|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
904296|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
904297|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904298|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904299|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
904300|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
904301|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904302|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904303|NCT01077310|O4|Outcome|Placebo, Received 4-6 Injections|
904304|NCT01077310|O3|Outcome|Extended-release Naltrexone, Received 4-6 Injections|
904305|NCT01077310|O2|Outcome|Placebo, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904306|NCT01077310|O1|Outcome|Extended-release Naltrexone, Received 0-3 Injections|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904307|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904308|NCT01077310|O1|Outcome|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904309|NCT01077310|O2|Outcome|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904310|NCT01077310|O1|Outcome|Intramuscular Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904311|NCT01077310|E2|Reported Event|Placebo|"Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail.~Placebo: Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug."
904312|NCT01077310|E1|Reported Event|Extended-release Naltrexone|"Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.~Vivitrol- Intramuscular naltrexone (depot-formulation): Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail."
904313|NCT01077284|B4|Baseline|Total|Total of all reporting groups
904314|NCT01077284|B3|Baseline|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
904315|NCT01077284|B2|Baseline|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
904316|NCT01077284|B1|Baseline|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
904317|NCT01077284|P3|Participant Flow|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
904318|NCT01077284|P2|Participant Flow|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
904319|NCT01077284|P1|Participant Flow|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
904320|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
904321|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
904322|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
904323|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
904324|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
904325|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
904326|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
904327|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
904328|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
904329|NCT01077284|O3|Outcome|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
904330|NCT01077284|O2|Outcome|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
904331|NCT01077284|O1|Outcome|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
904332|NCT01077284|E3|Reported Event|Placebo|Placebo-matching capsules, orally, once daily for up to 6 months.
904333|NCT01077284|E2|Reported Event|Allopurinol|Allopurinol 200mg or 300mg (determined by kidney function), capsules, orally, once daily for up to 6 months.
904334|NCT01077284|E1|Reported Event|Febuxostat|Febuxostat 80 mg, capsules, orally, once daily for up to 6 months.
904335|NCT01077271|B5|Baseline|Total|Total of all reporting groups
904336|NCT01077271|B4|Baseline|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904337|NCT01077271|B3|Baseline|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904338|NCT01077271|B2|Baseline|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904339|NCT01077271|B1|Baseline|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904340|NCT01077271|P1|Participant Flow|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
904341|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
904342|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904343|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904344|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904345|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904346|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
904347|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904348|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904349|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904350|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904745|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
904354|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904355|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904356|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
904357|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904358|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904359|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904360|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904361|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
904362|NCT01077271|O4|Outcome|No Matching RSV Season (NS)|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904363|NCT01077271|O3|Outcome|RSV Season 3 (S3)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904364|NCT01077271|O2|Outcome|RSV Season 2 (S2)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904365|NCT01077271|O1|Outcome|RSV Season 1 (S1)|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904366|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
904367|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904368|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904369|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904370|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904371|NCT01077271|O5|Outcome|Total|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab
904372|NCT01077271|O4|Outcome|No Matching RSV Season|Premature infants 33 - 35 weeks gestational age whose palivizumab administration did not occur within Season 1, 2 or 3
904373|NCT01077271|O3|Outcome|RSV Season 3|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the third respiratory syncytial virus season (01 Nov 2010 through 31 March 2011)
904374|NCT01077271|O2|Outcome|RSV Season 2|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the second respiratory syncytial virus season (01 Nov 2009 through 31 March 2010)
904375|NCT01077271|O1|Outcome|RSV Season 1|Premature infants 33 - 35 weeks gestational age prophylaxed with palivizumab who were enrolled during the first respiratory syncytial virus season (01 Nov 2008 through 31 March 2009)
904376|NCT01077271|E1|Reported Event|Premature Infants 33 - 35 wGA Prophylaxed With Palivizumab|Premature infants 33 - 35 weeks gestational age (wGA) prophylaxed with palivizumab
904377|NCT01077258|B1|Baseline|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904378|NCT01077258|P1|Participant Flow|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904379|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
904380|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
904381|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
904382|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
904383|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
904384|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
904385|NCT01077258|O1|Outcome|Month 0|Baseline
904386|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904387|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904388|NCT01077258|O6|Outcome|Month 24|24 months after inclusion
904389|NCT01077258|O5|Outcome|Month 18|18 months after inclusion
904390|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
904391|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
904392|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
904393|NCT01077258|O1|Outcome|Month 0|Baseline
904394|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904395|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904396|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904397|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904399|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904400|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904401|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904402|NCT01077258|O7|Outcome|Month 24|24 months after inclusion
904403|NCT01077258|O6|Outcome|Month 18|18 months after inclusion
904404|NCT01077258|O5|Outcome|Month 12|12 months after inclusion
904405|NCT01077258|O4|Outcome|Month 9|9 months after inclusion
904406|NCT01077258|O3|Outcome|Month 6|6 months after inclusion
904407|NCT01077258|O2|Outcome|Month 3|3 months after inclusion
904408|NCT01077258|O1|Outcome|Month 0|Baseline
904409|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904410|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904411|NCT01077258|O1|Outcome|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904412|NCT01077258|E1|Reported Event|Rheumatoid Arthritis|Participants with rheumatoid arthritis prescribed adalimumab in routine clinical practice were observed for up to 24 months.
904413|NCT01077193|B1|Baseline|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
904414|NCT01077193|P1|Participant Flow|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
904415|NCT01077193|O1|Outcome|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
904416|NCT01077193|E1|Reported Event|Gastric Plication Surgery|"Gastric Plication : A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
904417|NCT01077128|B1|Baseline|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
904418|NCT01077128|P1|Participant Flow|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
904419|NCT01077128|O1|Outcome|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab were followed for the long term use and safety of Adalimumab. For more detailed information, please see the Adverse Events section.
904420|NCT01077128|O4|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 12|All eligible patients with psoriasis treated with Adalimumab
904421|NCT01077128|O3|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 8|All eligible patients with psoriasis treated with Adalimumab
904422|NCT01077128|O2|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 4|All eligible patients with psoriasis treated with Adalimumab
904423|NCT01077128|O1|Outcome|EQ-5D VAS- Mean Change From Baseline-Month 1|All eligible patients with psoriasis treated with Adalimumab
904424|NCT01077128|O25|Outcome|EQ5D- Anxiety/Depression- Month 12|All eligible patients with psoriasis treated with Adalimumab
904425|NCT01077128|O24|Outcome|EQ5D- Anxiety/Depression- Month 8|All eligible patients with psoriasis treated with Adalimumab
904426|NCT01077128|O23|Outcome|EQ5D- Anxiety/Depression- Month 4|All eligible patients with psoriasis treated with Adalimumab
904427|NCT01077128|O22|Outcome|EQ5D- Anxiety/Depression- Month 1|All eligible patients with psoriasis treated with Adalimumab
904428|NCT01077128|O21|Outcome|EQ5D- Anxiety/Depression- Baseline|All eligible patients with psoriasis treated with Adalimumab
904429|NCT01077128|O20|Outcome|EQ5D- Pain/Discomfort- Month 12|All eligible patients with psoriasis treated with Adalimumab
917302|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
904430|NCT01077128|O19|Outcome|EQ5D- Pain/Discomfort- Month 8|All eligible patients with psoriasis treated with Adalimumab
904431|NCT01077128|O18|Outcome|EQ5D- Pain/Discomfort- Month 4|All eligible patients with psoriasis treated with Adalimumab
904432|NCT01077128|O17|Outcome|EQ5D- Pain/Discomfort- Month 1|All eligible patients with psoriasis treated with Adalimumab
904433|NCT01077128|O16|Outcome|EQ5D- Pain/Discomfort- Baseline|All eligible patients with psoriasis treated with Adalimumab
904434|NCT01077128|O15|Outcome|EQ5D- Usual Activities- Month 12|All eligible patients with psoriasis treated with Adalimumab
904435|NCT01077128|O14|Outcome|EQ5D- Usual Activities- Month 8|All eligible patients with psoriasis treated with Adalimumab
904436|NCT01077128|O13|Outcome|EQ5D- Usual Activities- Month 4|All eligible patients with psoriasis treated with Adalimumab
904437|NCT01077128|O12|Outcome|EQ5D- Usual Activities- Month 1|All eligible patients with psoriasis treated with Adalimumab
904438|NCT01077128|O11|Outcome|EQ5D- Usual Activities- Baseline|All eligible patients with psoriasis treated with Adalimumab
904439|NCT01077128|O10|Outcome|EQ5D- Self-care- Month 12|All eligible patients with psoriasis treated with Adalimumab
904440|NCT01077128|O9|Outcome|EQ5D- Self-care- Month 8|All eligible patients with psoriasis treated with Adalimumab
904441|NCT01077128|O8|Outcome|EQ5D- Self-care- Month 4|All eligible patients with psoriasis treated with Adalimumab
904442|NCT01077128|O7|Outcome|EQ5D- Self-care- Month 1|All eligible patients with psoriasis treated with Adalimumab
904443|NCT01077128|O6|Outcome|EQ5D- Self-care- Baseline|All eligible patients with psoriasis treated with Adalimumab
904444|NCT01077128|O5|Outcome|EQ5D- Mobility- Month 12|All eligible patients with psoriasis treated with Adalimumab
904445|NCT01077128|O4|Outcome|EQ5D- Mobility- Month 8|All eligible patients with psoriasis treated with Adalimumab
904446|NCT01077128|O3|Outcome|EQ5D- Mobility- Month 4|All eligible patients with psoriasis treated with Adalimumab
904447|NCT01077128|O2|Outcome|EQ5D- Mobility- Month 1|All eligible patients with psoriasis treated with Adalimumab
904448|NCT01077128|O1|Outcome|EQ5D- Mobility- Baseline|All eligible patients with psoriasis treated with Adalimumab
904449|NCT01077128|O17|Outcome|DLQI Score Change Baseline to Month 12- West Macedonia|All eligible patients with psoriasis treated with Adalimumab
904450|NCT01077128|O16|Outcome|DLQI Score Change Baseline to Month 12- West Greece|All eligible patients with psoriasis treated with Adalimumab
904451|NCT01077128|O15|Outcome|DLQI Score Change Baseline to Month 12- Thessaly|All eligible patients with psoriasis treated with Adalimumab
904452|NCT01077128|O14|Outcome|DLQI Score Change Baseline to Month 12- South Aegean|All eligible patients with psoriasis treated with Adalimumab
904453|NCT01077128|O13|Outcome|DLQI Score Change Baseline to Month 12- Peloponnese|All eligible patients with psoriasis treated with Adalimumab
904454|NCT01077128|O12|Outcome|DLQI Score Change Baseline to Month 12- North Aegean|All eligible patients with psoriasis treated with Adalimumab
904455|NCT01077128|O11|Outcome|DLQI Score Change Baseline to Month 12- Ionian Islands|All eligible patients with psoriasis treated with Adalimumab
904456|NCT01077128|O10|Outcome|DLQI Score Change Baseline to Month 12- Epirus|All eligible patients with psoriasis treated with Adalimumab
904457|NCT01077128|O9|Outcome|DLQI Score Change Baseline to Month 12- East Macedonia/Thrace|All eligible patients with psoriasis treated with Adalimumab
904458|NCT01077128|O8|Outcome|DLQI Score Change Baseline to Month 12- Crete|All eligible patients with psoriasis treated with Adalimumab
904459|NCT01077128|O7|Outcome|DLQI Score Change Baseline to Month 12- Central Macedonia|All eligible patients with psoriasis treated with Adalimumab
904460|NCT01077128|O6|Outcome|DLQI Score Change Baseline to Month 12- Central Greece|All eligible patients with psoriasis treated with Adalimumab
904461|NCT01077128|O5|Outcome|DLQI Score Change Baseline to Month 12- Attica|All eligible patients with psoriasis treated with Adalimumab
904462|NCT01077128|O4|Outcome|DLQI Score Change by PGA Response Group- Month 12|All eligible patients with psoriasis treated with Adalimumab
904463|NCT01077128|O3|Outcome|DLQI Score Change by PGA Response Group- Month 8|All eligible patients with psoriasis treated with Adalimumab
904464|NCT01077128|O2|Outcome|DLQI Score Change by PGA Response Group- Month 4|All eligible patients with psoriasis treated with Adalimumab
904465|NCT01077128|O1|Outcome|DLQI Score Change by PGA Response Group- Month 1|All eligible patients with psoriasis treated with Adalimumab
904466|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
904467|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
904468|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
904469|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
904470|NCT01077128|O4|Outcome|Patients With Psoriasis- Month 12|All eligible patients with psoriasis treated with Adalimumab
904471|NCT01077128|O3|Outcome|Patients With Psoriasis- Month 8|All eligible patients with psoriasis treated with Adalimumab
904472|NCT01077128|O2|Outcome|Patients With Psoriasis- Month 4|All eligible patients with psoriasis treated with Adalimumab
904473|NCT01077128|O1|Outcome|Patients With Psoriasis- Month 1|All eligible patients with psoriasis treated with Adalimumab
904474|NCT01077128|E1|Reported Event|Patients With Psoriasis|All eligible patients with psoriasis treated with Adalimumab
904475|NCT01077076|B1|Baseline|Entire Study Population|
904476|NCT01077076|P6|Participant Flow|Placebo/Prilosec/Zegerid|Participants received Placebo Capsules in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
904477|NCT01077076|P5|Participant Flow|Placebo/Zegerid/Prilosec|Participants received Placebo Capsules in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
904746|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
904565|NCT01076686|P4|Participant Flow|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904478|NCT01077076|P4|Participant Flow|Prilosec/Placebo/Zegerid|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the third intervention (after the washout period).
904479|NCT01077076|P3|Participant Flow|Prilosec/Zegerid/Placebo|Participants received Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the first intervention, Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
904480|NCT01077076|P2|Participant Flow|Zegerid/Placebo/Prilosec|Participants received Zegerid OTC Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Placebo Capsules in the second intervention (after the washout period), and Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the third intervention (after the washout period).
904481|NCT01077076|P1|Participant Flow|Zegerid/Prilosec/Placebo|Participants received Zegerid over-the-counter (OTC) Capsules (20 mg omeprazole and 1100 mg sodium bicarbonate) in the first intervention, Prilosec OTC Tablets (20 mg-equivalent omeprazole) in the second intervention (after the washout period), and Placebo Capsules in the third intervention (after the washout period).
904482|NCT01077076|O3|Outcome|Placebo Capsules|
904483|NCT01077076|O2|Outcome|Prilosec OTC Tablets|20 mg-equivalent omeprazole
904484|NCT01077076|O1|Outcome|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
904485|NCT01077076|E3|Reported Event|Placebo Capsules|
904486|NCT01077076|E2|Reported Event|Prilosec OTC Tablets|20 mg-equivalent omeprazole
904487|NCT01077076|E1|Reported Event|Zegerid OTC Capsules|20 mg omeprazole and 1100 mg sodium bicarbonate
904488|NCT01077063|B3|Baseline|Total|Total of all reporting groups
904489|NCT01077063|B2|Baseline|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
904490|NCT01077063|B1|Baseline|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
904491|NCT01077063|P2|Participant Flow|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
904492|NCT01077063|P1|Participant Flow|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
904493|NCT01077063|O2|Outcome|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
904494|NCT01077063|O1|Outcome|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
904495|NCT01077063|E2|Reported Event|Pleurx Catheter|"a catheter drainage system the subject uses himself/herself.~Pleurx catheter: take home catheter drainage system that the subject uses himself/herself as needed."
904496|NCT01077063|E1|Reported Event|Paracentesis|"cutting and draining procedure for malignant ascites~paracentesis: surgical drainage of malignant ascites"
904497|NCT01077050|B1|Baseline|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
904498|NCT01077050|P1|Participant Flow|Only One Arm in the Study, Thus Not Applicable.|
904499|NCT01077050|O1|Outcome|Biopsied Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
904500|NCT01077050|E1|Reported Event|Biopsied Skin Lesions|"Any adverse advent that occured on a skin/lesion site for whom there had been any contact between the subject's skin and investigational device (SciBase III).~Note that multiple adverse event occured on some subjects. In total 36 Adverse Events were reported on 28 subjects."
904501|NCT01077024|B3|Baseline|Total|Total of all reporting groups
904502|NCT01077024|B2|Baseline|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904503|NCT01077024|B1|Baseline|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904504|NCT01077024|P2|Participant Flow|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904505|NCT01077024|P1|Participant Flow|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904506|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904507|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904508|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904509|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904510|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904511|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904512|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904513|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904514|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904515|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904516|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904517|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904518|NCT01077024|O2|Outcome|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904519|NCT01077024|O1|Outcome|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904520|NCT01077024|E2|Reported Event|Substance-treatment as Usual|Treatment as usual is outpatient stimulant-dependence treatment as typically provided by the participating site.
904521|NCT01077024|E1|Reported Event|Smoking-cessation Treatment + Substance Treatment as Usual|Smoking-cessation treatment: Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
904522|NCT01076985|B1|Baseline|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904523|NCT01076985|P1|Participant Flow|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904524|NCT01076985|O2|Outcome|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection and participated in this noninterventional, post-marketing observational study.
904525|NCT01076985|O1|Outcome|Lopinavir/Ritonavir|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904526|NCT01076985|E2|Reported Event|Infants|Infants from live births of the pregnant women who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection who participated in this noninterventional, post-marketing observational study.
904527|NCT01076985|E1|Reported Event|Lopinavir/Ritonavir Group|All pregnant women in this noninterventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904528|NCT01076972|B1|Baseline|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904529|NCT01076972|P1|Participant Flow|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904530|NCT01076972|O7|Outcome|Lopinavir/Ritonavir: Baseline Category Unknown|The subgroup of participants whose CDC classification at Baseline (prior to treatment with lopinavir/ritonavir) was unknown.
904531|NCT01076972|O6|Outcome|Lopinavir/Ritonavir: Baseline Category P-2|The subgroup of participants who were classified as CDC Category P-2 at Baseline (prior to treatment with lopinavir/ritonavir).
904532|NCT01076972|O5|Outcome|Lopinavir/Ritonavir: Baseline Category P-1|The subgroup of participants who were classified as CDC Category P-1 at Baseline (prior to treatment with lopinavir/ritonavir).
904533|NCT01076972|O4|Outcome|Lopinavir/Ritonavir: Baseline Category P-0|The subgroup of participants who were classified as CDC Category P-0 at Baseline (prior to treatment with lopinavir/ritonavir).
904534|NCT01076972|O3|Outcome|Lopinavir/Ritonavir: Baseline Category C|The subgroup of patients who were classified as CDC Category C at Baseline (prior to treatment with lopinavir/ritonavir).
904535|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Baseline Category B|The subgroup of participants who were classified as CDC Category B at Baseline (prior to treatment with lopinavir/ritonavir).
904903|NCT01075763|B3|Baseline|Total|Total of all reporting groups
904536|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Baseline Category A|The subgroup of patients who were classified as CDC Category A at Baseline (prior to treatment with lopinavir/ritonavir).
904537|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 418 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
904538|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
904539|NCT01076972|O2|Outcome|Lopinavir/Ritonavir: Treatment-Experienced|The subgroup of patients who have received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 420 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
904540|NCT01076972|O1|Outcome|Lopinavir/Ritonavir: Treatment-Naive|The subgroup of patients who had not received prior antiretroviral drug therapy. Data for patients for whom either baseline data or data during treatment were missing for a given time point were excluded from the analysis for that time point. Of the 1184 total enrolled patients, 416 patients had baseline data and efficacy data for this outcome measure, and were therefore included in the analysis.
904541|NCT01076972|O1|Outcome|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904542|NCT01076972|E1|Reported Event|Lopinavir/Ritonavir Group|All patients in this non-interventional, post-marketing observational study, who were prescribed lopinavir/ritonavir (Kaletra) in accordance with the local Prescribing Information for the treatment of HIV infection.
904543|NCT01076959|B1|Baseline|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
904544|NCT01076959|P1|Participant Flow|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
904545|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good and Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
904546|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
904547|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
904548|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 4.at Week 24. All variables may not have been tested; therefore, a patient may not have been included.
904549|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
904550|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response to DAS 28 (improvement < 0.6) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
904551|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response to DAS 28 (improvement 0.6 to 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
904552|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response to DAS 28 (improvement > 1.2) at Week 12. All variables may not have been tested; therefore, a patient may not have been included.
904553|NCT01076959|O4|Outcome|Effective Rate-Sum of Patients With Good or Moderate Response|Patients who received Humira during the PMDA review period and had a moderate or good response to DAS 28 (improvement =>0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
904554|NCT01076959|O3|Outcome|Humira - No Response|Patients who received Humira during the PMDA review period and had no response according to DAS 28 (improvement <0.6) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
904555|NCT01076959|O2|Outcome|Humira - Moderate Response|Patients who received Humira during the PMDA review period and had a moderate response according to DAS 28 (improvement 0.6 to 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
904556|NCT01076959|O1|Outcome|Humira - Good Response|Patients who received Humira during the PMDA review period and had a good response according to DAS 28 (improvement > 1.2) at Week 4. All variables may not have been tested; therefore, a patient may not have been included.
904557|NCT01076959|O1|Outcome|Physician Response Rating|The full analysis set was used to determine the physicians' overall response rating.
904558|NCT01076959|O1|Outcome|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
904559|NCT01076959|E1|Reported Event|Humira|Patients who received Humira for 24 weeks during the PMDA review period.
904560|NCT01076686|B5|Baseline|Total|Total of all reporting groups
904561|NCT01076686|B4|Baseline|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904562|NCT01076686|B3|Baseline|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
904563|NCT01076686|B2|Baseline|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904564|NCT01076686|B1|Baseline|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904566|NCT01076686|P3|Participant Flow|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
904567|NCT01076686|P2|Participant Flow|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904568|NCT01076686|P1|Participant Flow|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904569|NCT01076686|O4|Outcome|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904570|NCT01076686|O3|Outcome|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
904571|NCT01076686|O2|Outcome|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904572|NCT01076686|O1|Outcome|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904573|NCT01076686|E4|Reported Event|High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904574|NCT01076686|E3|Reported Event|Bupivacaine|Single dose of study drug was injected locally into the breast pockets
904575|NCT01076686|E2|Reported Event|Bupivacaine and High Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904576|NCT01076686|E1|Reported Event|Bupivacaine and Low Dose SKY0402|Single dose of study drug was injected locally into the breast pockets
904577|NCT01076647|B3|Baseline|Total|Total of all reporting groups
904578|NCT01076647|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904579|NCT01076647|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904580|NCT01076647|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904581|NCT01076647|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904582|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904583|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904584|NCT01076647|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904585|NCT01076647|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904586|NCT01076647|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) same time each day according to local labelling with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904587|NCT01076647|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200 U/ml was given thrice weekly on Mondays, Wednesdays and Fridays subcutaneously (s.c.) in the evening with pre-trial metformin and with or without pre-trial DPP-4 for 26 weeks.
904588|NCT01076504|B1|Baseline|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904589|NCT01076504|P1|Participant Flow|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904590|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904591|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904592|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904593|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904594|NCT01076504|O1|Outcome|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904595|NCT01076504|E1|Reported Event|Amrubicin/Carboplatin With Pegfilgrastim|"Systemic therapy~Amrubicin: 30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle~Carboplatin: AUC=5 IV, Day 1 of each 3-week treatment cycle~Pegfilgrastim: 6 mg SQ on Day 4 of each 3 week treatment cycle"
904596|NCT01076452|B3|Baseline|Total|Total of all reporting groups
904597|NCT01076452|B2|Baseline|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904598|NCT01076452|B1|Baseline|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904599|NCT01076452|P2|Participant Flow|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904773|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
917355|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
904600|NCT01076452|P1|Participant Flow|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904601|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904602|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904603|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904604|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904605|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904606|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904607|NCT01076452|O2|Outcome|GPi (Globus Pallidus)|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904608|NCT01076452|O1|Outcome|STN (Subthalamic Nucleus)|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904609|NCT01076452|E2|Reported Event|Arm 2|"GPi (Globus Pallidus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904610|NCT01076452|E1|Reported Event|Arm 1|"STN (Subthalamic Nucleus)~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
904611|NCT01076361|B1|Baseline|All Enrolled Patients|All patients who were enrolled and implanted with a Model 4968 Lead
904612|NCT01076361|P1|Participant Flow|Model 4968 Leads|A total of 631 leads were implanted in 370 patients. 22 leads in 21 patients were excluded from analysis.
904613|NCT01076361|O1|Outcome|Model 4968 Lead Survival Probability|Model 4968 is steroid-eluting bipolar epicardial pacing lead. Participants implanted with Model 4968 lead their data will be obtained for long-term safety and lead events, includes the survival probability for the Model 4968.
904614|NCT01076361|E1|Reported Event|Model 4968 Participants|All Model 4968 participants in the analysis cohort
904615|NCT01076348|B1|Baseline|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
904616|NCT01076348|P1|Participant Flow|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
904617|NCT01076348|O1|Outcome|Medtronic 4965 Epicardial Lead|Subjects who were implanted with at least 1 model 4965 lead.
904618|NCT01076348|E1|Reported Event|Medtronic 4965 Subjects|Single arm registry of Model 4965 implanted patients
904619|NCT01076335|B1|Baseline|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
904620|NCT01076335|P1|Participant Flow|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
904621|NCT01076335|O1|Outcome|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
904622|NCT01076335|E1|Reported Event|Neoadjuvant Hormones + Docetaxel|One year Neoadjuvant Hormonal Therapy of LHRH Agonist Depot injection (monthly or quarterly) plus three cycles Docetaxel 35 mg/m^2 weekly intravenous (IV) (approximately 4 months) followed by Radical Prostatectomy
904623|NCT01076296|B1|Baseline|Total for All Groups Assessed|Subjects assessed for LV function using both VScan and a clinical examination.
904624|NCT01076296|P8|Participant Flow|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
904625|NCT01076296|P7|Participant Flow|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
904626|NCT01076296|P6|Participant Flow|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
904627|NCT01076296|P5|Participant Flow|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
904628|NCT01076296|P4|Participant Flow|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
904629|NCT01076296|P3|Participant Flow|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
904630|NCT01076296|P2|Participant Flow|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
904631|NCT01076296|P1|Participant Flow|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
904632|NCT01076296|O8|Outcome|No Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting no presence of HVD.
904633|NCT01076296|O7|Outcome|Heart Valve Disease|Subjects assessed for Heart Valve Disease function with both VScan and a clinical examination noting the presence of HVD.
904634|NCT01076296|O6|Outcome|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the no presence of pulmonary hypertension.
904934|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
904635|NCT01076296|O5|Outcome|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension function with both VScan and a clinical examination noting the presence of pulmonary hypertension.
904636|NCT01076296|O4|Outcome|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
904637|NCT01076296|O3|Outcome|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
904638|NCT01076296|O2|Outcome|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
904639|NCT01076296|O1|Outcome|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
904640|NCT01076296|E8|Reported Event|No Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting no presence of HVD.
904641|NCT01076296|E7|Reported Event|Heart Valve Disease|Subjects assessed for HVD with both VScan and a clinical examination noting the presence of HVD.
904642|NCT01076296|E6|Reported Event|No Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting no presence of pulmonary hypertension.
904643|NCT01076296|E5|Reported Event|Pulmonary Hypertension|Subjects assessed for Pulmonary Hypertension with both VScan and a clinical examination noting the presence of pulmonary hypertension.
904644|NCT01076296|E4|Reported Event|Normal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting no abnormality.
904645|NCT01076296|E3|Reported Event|Abnormal Right Ventricle Function|Subjects assessed for RV function with both VScan and a clinical examination noting an abnormality.
904646|NCT01076296|E2|Reported Event|Normal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting no abnormality.
904647|NCT01076296|E1|Reported Event|Abnormal Left Ventricle Function|Subjects assessed for LV function with both VScan and a clinical examination noting an abnormality.
904648|NCT01076283|B3|Baseline|Total|Total of all reporting groups
904649|NCT01076283|B2|Baseline|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
904650|NCT01076283|B1|Baseline|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
904651|NCT01076283|P2|Participant Flow|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
904652|NCT01076283|P1|Participant Flow|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
904653|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
904654|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
904655|NCT01076283|O2|Outcome|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
904656|NCT01076283|O1|Outcome|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
904657|NCT01076283|E2|Reported Event|Cyproheptadine|Cyproheptadine 2 mg t.i.d. for 8-10 days
904658|NCT01076283|E1|Reported Event|Baclofen|Baclofen 10 mg three times a day (t.i.d.) for 8-10 days
904664|NCT01076244|B1|Baseline|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
904665|NCT01076244|P1|Participant Flow|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
904666|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
904667|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
904668|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
904669|NCT01076244|O1|Outcome|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
904670|NCT01076244|E1|Reported Event|Minimally Invasive Lumbar Decompression|Lumbar spinal stenosis patients exhibiting neurogenic claudication with predominance of ligamentum flavum hypertrophy were treated percutaneously using the mild Device Kit to decompress the target area.
904671|NCT01076192|B1|Baseline|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904672|NCT01076192|P1|Participant Flow|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904673|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with adalimumab in routine clinical practice
904674|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904675|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904676|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904677|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904678|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904679|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904774|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
904680|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904681|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904682|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904683|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904684|NCT01076192|O1|Outcome|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904685|NCT01076192|E1|Reported Event|Moderate-to-severe Chronic Plaque Psoriasis|Participants with moderate-to-severe chronic plaque psoriasis treated with Humira® in routine clinical practice
904686|NCT01076179|B1|Baseline|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904687|NCT01076179|P1|Participant Flow|HIV-infected Participants|Human immunodeficiency virus (HIV)-infected participants on Kaletra and integrase inhibitors (INIs) or non nucleoside reverse transcriptase inhibitors NNRTIs) or C-C chemokine receptor type 5 (CCR5) antagonists
904688|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
904689|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
904690|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904691|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904692|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904693|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904694|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904695|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904696|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904697|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904698|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904699|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904700|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904701|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904702|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904703|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904704|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904705|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904706|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904707|NCT01076179|O1|Outcome|HIV-infected Participants|HIV-infected participants on Kaletra and INIs or NNRTIs or CCR5 antagonists
904708|NCT01076179|E1|Reported Event|HIV-infected Participants|HIV-infected participants on Kaletra and integrase inhibitors or non nucleoside reverse transcriptase inhibitors or CCR5 antagonists
904709|NCT01076166|B1|Baseline|Klacid Granules (Total)|The per-protocol population (308 participants) of male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
904710|NCT01076166|P1|Participant Flow|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
904711|NCT01076166|O1|Outcome|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
904712|NCT01076166|O3|Outcome|Klacid Granules (Pneumonia, Recovered)|Participants in the recovered population who had a diagnosis of pneumonia at study entry.
904713|NCT01076166|O2|Outcome|Klacid Granules (Bronchitis, Recovered)|Participants in the recovered population who had a diagnosis of bronchitis at study entry.
904714|NCT01076166|O1|Outcome|Klacid Granules (Total Number Recovered)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information who were in the recovered population.
904715|NCT01076166|E1|Reported Event|Klacid Granules (Total)|Male or female Thai children more than 6 months and less than 12 years of age with lower respiratory tract infections treated with Klacid (clarithromycin) Granules for Oral Suspension according to the Prescribing Information.
904716|NCT01076153|B1|Baseline|Klacid MR|The per-protocol population (694 participants) of male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR.
904717|NCT01076153|P1|Participant Flow|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
904775|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg
906737|NCT01071252|E1|Reported Event|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
904718|NCT01076153|O1|Outcome|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
904719|NCT01076153|O4|Outcome|Klacid MR (URTI and LRTI, Recovered)|Participants in the recovered population who had a diagnosis of both upper and lower respiratory tract infections at study entry.
904720|NCT01076153|O3|Outcome|Klacid MR (LRTI, Recovered)|Participants in the recovered population who had a diagnosis of lower respiratory tract infection (LRTI) at study entry.
904721|NCT01076153|O2|Outcome|Klacid MR (URTI, Recovered)|Participants in the recovered population who had a diagnosis of upper respiratory tract infection (URTI) at study entry.
904722|NCT01076153|O1|Outcome|Klacid MR (Total Number Recovered)|Male or female Thai adults with upper and/or lower respiratory tract infections on Klacid MR who were in the recovered population.
904723|NCT01076153|E1|Reported Event|Klacid MR|Male or female Thai adults with upper and/or lower respiratory tract infections taking Klacid (clarithromycin) modified release (MR) 500 mg according to the Prescribing Information.
904724|NCT01076088|B7|Baseline|Total|Total of all reporting groups
904725|NCT01076088|B6|Baseline|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
904726|NCT01076088|B5|Baseline|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
904727|NCT01076088|B4|Baseline|Metformin 850|Metformin 850 mg twice daily
904728|NCT01076088|B3|Baseline|Metformin 500 mg|Metformin 500 mg twice daily
904729|NCT01076088|B2|Baseline|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
904730|NCT01076088|B1|Baseline|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
904731|NCT01076088|P6|Participant Flow|Placebo|Matching placebo to sitagliptin and/or metformin. Population includes 1 participant who did not receive any study medication.
904732|NCT01076088|P5|Participant Flow|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
904733|NCT01076088|P4|Participant Flow|Metformin 850|Metformin 850 mg twice daily
904734|NCT01076088|P3|Participant Flow|Metformin 500 mg|Metformin 500 mg twice daily
904735|NCT01076088|P2|Participant Flow|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
904736|NCT01076088|P1|Participant Flow|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
904737|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
904738|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
904739|NCT01076088|O4|Outcome|Metformin 850|Metformin 850 mg twice daily
904740|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
904741|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
904742|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
904743|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
904744|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
904747|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
904748|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
904749|NCT01076088|O6|Outcome|Placebo|Matching placebo to sitagliptin and/or metformin
904750|NCT01076088|O5|Outcome|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
904751|NCT01076088|O4|Outcome|Metformin 850 mg|Metformin 850 mg twice daily
904752|NCT01076088|O3|Outcome|Metformin 500 mg|Metformin 500 mg twice daily
904753|NCT01076088|O2|Outcome|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
904754|NCT01076088|O1|Outcome|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
904755|NCT01076088|E6|Reported Event|Placebo|Matching placebo to sitagliptin and/or metformin. Population excludes 1 participant who did not receive any study medication.
904756|NCT01076088|E5|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
904757|NCT01076088|E4|Reported Event|Metformin 850|Metformin 850 mg twice daily
904758|NCT01076088|E3|Reported Event|Metformin 500 mg|Metformin 500 mg twice daily
904759|NCT01076088|E2|Reported Event|Sitagliptin 50 mg + Metformin 850 mg|Sitagliptin 50 mg twice daily + metformin 850 mg twice daily
904760|NCT01076088|E1|Reported Event|Sitagliptin 50 mg + Metformin 500 mg|Sitagliptin 50 mg twice daily + metformin 500 mg twice daily
904761|NCT01076075|B3|Baseline|Total|Total of all reporting groups
904762|NCT01076075|B2|Baseline|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
904763|NCT01076075|B1|Baseline|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
904764|NCT01076075|P2|Participant Flow|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
904765|NCT01076075|P1|Participant Flow|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
904766|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
904767|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
904768|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Weeks 0-24: Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
904769|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
904770|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
904771|NCT01076075|O1|Outcome|Sitagliptin|Phase A (Week 0-24): Sitagliptin 100 mg
904772|NCT01076075|O2|Outcome|Placebo/Pioglitazone|Phase A (Week 0-24): Placebo to Sitagliptin 100 mg
904776|NCT01076075|E2|Reported Event|Placebo/Pioglitazone|Phase A (Weeks 0-24): Placebo to Sitagliptin 100 mg; Phase B (Weeks 24-54): Placebo to Sitagliptin 100 mg + Pioglitazone 30 mg
904777|NCT01076075|E1|Reported Event|Sitagliptin|Phase A (Weeks 0-24): Sitagliptin 100 mg; Phase B (Weeks 24-54): Sitagliptin 100 mg + Placebo to Pioglitazone
904778|NCT01076036|B1|Baseline|Investigational|CorPath® 200 System
904779|NCT01076036|P1|Participant Flow|Group 1|Group 1 was treated using the CorPath device.
904780|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
904781|NCT01076036|O1|Outcome|Investigational|CorPath® 200 System
904782|NCT01076036|E1|Reported Event|Investigational|CorPath® 200 System
904783|NCT01075984|B6|Baseline|Total|Total of all reporting groups
904784|NCT01075984|B5|Baseline|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904785|NCT01075984|B4|Baseline|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904786|NCT01075984|B3|Baseline|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904787|NCT01075984|B2|Baseline|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904788|NCT01075984|B1|Baseline|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904789|NCT01075984|P5|Participant Flow|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904790|NCT01075984|P4|Participant Flow|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904791|NCT01075984|P3|Participant Flow|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904792|NCT01075984|P2|Participant Flow|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904793|NCT01075984|P1|Participant Flow|Posaconazole (POS) 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904794|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904795|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904796|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904797|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904798|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904799|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904800|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904801|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904802|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904803|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904804|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904805|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904806|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904807|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
905231|NCT01075152|B1|Baseline|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis.
904808|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904809|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904810|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904811|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904812|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904813|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904814|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904815|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904816|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904817|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904818|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904819|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904820|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904821|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904822|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904823|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904824|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904825|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904826|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904827|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904828|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904829|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904830|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904831|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904832|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904833|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904834|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904835|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904836|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 3)|POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904837|NCT01075984|O2|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904838|NCT01075984|O1|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904839|NCT01075984|O3|Outcome|POS 300 mg IV BID (Cohort 2)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904840|NCT01075984|O2|Outcome|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904841|NCT01075984|O1|Outcome|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904842|NCT01075984|E4|Reported Event|POS 300 mg IV BID (Cohort 2 and 3)|POS 300 mg IV BID on Day 1, followed by POS 300 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 2); POS 300 mg IV BID on Day 1 followed by POS 300 mg IV once daily on Days 2 through 5, then by POS 200 mg oral TID or POS 400 mg oral BID through Day 28 or POS 200-300 mg IV once daily as required (Cohort 3). After Day 5, POS IV was administered continuously or intermittently, depending on oral tolerability.
904843|NCT01075984|E3|Reported Event|POS 200 mg IV BID (Cohort 1)|POS 200 mg IV BID on Day 1, followed by POS 200 mg IV once daily on Days 2 through 14, then by POS 400 mg oral BID through Day 28 (Cohort 1)
904844|NCT01075984|E2|Reported Event|Placebo IV Single Dose (Cohort 0)|Placebo IV single dose on Day 1, followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904845|NCT01075984|E1|Reported Event|POS 200 mg IV Single Dose (Cohort 0)|POS 200 mg IV single dose on Day 1 followed 12 hours later by POS oral 400 mg, then by POS oral 400 mg BID on Days 2 through 6 and a single morning dose on Day 7 (Cohort 0)
904846|NCT01075971|B1|Baseline|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
904847|NCT01075971|P1|Participant Flow|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
904848|NCT01075971|O1|Outcome|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
904849|NCT01075971|E1|Reported Event|Buprenorphine Hydrochloride|8 or 16 mg daily for 5 days; marketed sublingual tablet on Days 1 and 2, fast dissolving tablet (FDT) on Days 3, 4, and 5
904850|NCT01075958|B1|Baseline|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
904851|NCT01075958|P1|Participant Flow|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
904852|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904853|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904854|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904855|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904856|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904857|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904858|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904859|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904860|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904861|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904862|NCT01075958|O1|Outcome|Healthy Participants|All eligible participants.
904863|NCT01075958|E1|Reported Event|Healthy Participants|Participants declared themselves as healthy, a non-smoker and prescription and herbal medication free.
904864|NCT01075815|B3|Baseline|Total|Total of all reporting groups
904865|NCT01075815|B2|Baseline|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904866|NCT01075815|B1|Baseline|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904867|NCT01075815|P2|Participant Flow|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904868|NCT01075815|P1|Participant Flow|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904869|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904891|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904870|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904871|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904872|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904873|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904874|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904875|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904876|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904877|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904878|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904879|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904880|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904935|NCT01075685|O2|Outcome|Minimum Information|
904936|NCT01075685|O1|Outcome|Web-based Alcohol Programme|
904881|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904882|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904883|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904884|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904885|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904886|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904887|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904888|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904889|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904890|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
905554|NCT01074125|O2|Outcome|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
904892|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904893|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904894|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904895|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904896|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904897|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904898|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904899|NCT01075815|O2|Outcome|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904900|NCT01075815|O1|Outcome|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904901|NCT01075815|E2|Reported Event|rFSH|Recombinant follicle stimulating hormone (rFSH) injection 300 IU subcutaneously daily from S1 to S4 and then dose adjusted depending on the ovarian response till r-hCG administration day.
904902|NCT01075815|E1|Reported Event|rFSH + rhLH|Recombinant human luteinizing hormone (rhLH, Luveris®) injection 150 International Units (IU) subcutaneously daily along with recombinant follicle-stimulating hormone (rFSH) 300 IU subcutaneously daily from Day 1 of stimulation period (S1) to Day 4 of stimulation period (S4) and then rFSH dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day.
904904|NCT01075763|B2|Baseline|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904905|NCT01075763|B1|Baseline|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904906|NCT01075763|P2|Participant Flow|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904907|NCT01075763|P1|Participant Flow|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904908|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904909|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904910|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904911|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904912|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904913|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904914|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904915|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
905555|NCT01074125|O1|Outcome|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
904916|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904917|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904918|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904919|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904920|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904921|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904922|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904923|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904924|NCT01075763|O2|Outcome|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904925|NCT01075763|O1|Outcome|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif®) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904926|NCT01075763|E2|Reported Event|Placebo|Single dose of matching placebo injection administered sc tiw at a dose of 4.4 mcg for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period of 28 weeks).
904927|NCT01075763|E1|Reported Event|Rebif 22 Mcg|Single dose of interferon beta-1a (Rebif) injection administered subcutaneously (sc) three times per week (tiw) at a dose of 4.4 microgram (mcg) for first 2 weeks followed by 11 mcg for next 2 weeks and finally 22 mcg for remaining 24 weeks (treatment period 28 weeks).
904928|NCT01075685|B3|Baseline|Total|Total of all reporting groups
904929|NCT01075685|B2|Baseline|Minimum Information|
904930|NCT01075685|B1|Baseline|Web-based Alcohol Programme|
904931|NCT01075685|P2|Participant Flow|Minimum Information|
904932|NCT01075685|P1|Participant Flow|Web-based Alcohol Programme|
904933|NCT01075685|O2|Outcome|Minimum Information|
904944|NCT01075646|B4|Baseline|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904945|NCT01075646|B3|Baseline|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904946|NCT01075646|B2|Baseline|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904947|NCT01075646|B1|Baseline|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904948|NCT01075646|P4|Participant Flow|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904949|NCT01075646|P3|Participant Flow|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904950|NCT01075646|P2|Participant Flow|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904951|NCT01075646|P1|Participant Flow|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904952|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904953|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904954|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904955|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904956|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904957|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904958|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904959|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904960|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904961|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904962|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904963|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904964|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904965|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904966|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904967|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904968|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904969|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904970|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904997|NCT01075282|B2|Baseline|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
906738|NCT01071200|B3|Baseline|Total|Total of all reporting groups
904971|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904972|NCT01075646|O4|Outcome|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904973|NCT01075646|O3|Outcome|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904974|NCT01075646|O2|Outcome|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904975|NCT01075646|O1|Outcome|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904976|NCT01075646|E4|Reported Event|Saline Solution Hepatic Surgery|After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h
904977|NCT01075646|E3|Reported Event|Ropivacaine Hepatic Surgery|After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours Hepatic surgery: 10 ml of ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h.
904978|NCT01075646|E2|Reported Event|Saline Solution Colorectal Surgery|"After a bolus administration of saline solution a perfusion ot saline solution is initiated through an elastomeric wound during 48 hours~placebo: Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h."
904979|NCT01075646|E1|Reported Event|Ropivacaine Colorectal Surgery|"After a bolus administration of Ropivacaine a perfusion ot the same anesthetic is initiated through an elastomeric wound during 48 hours~ropivacaine: Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h."
904980|NCT01075399|B1|Baseline|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
905013|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
904981|NCT01075399|P1|Participant Flow|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
904982|NCT01075399|O1|Outcome|Subjects That Received 1st and 2nd [F18] HX4 Scans|Single arm study. This group includes all subjects that successfully received [F18]HX4 PET scan on 2 separate occasions within 6 days apart to assess reproducibility in measuring tumor hypoxia.
904983|NCT01075399|E1|Reported Event|[F 18]HX4|[F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
904984|NCT01075347|B3|Baseline|Total|Total of all reporting groups
904985|NCT01075347|B2|Baseline|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
904986|NCT01075347|B1|Baseline|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
904987|NCT01075347|P2|Participant Flow|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
904988|NCT01075347|P1|Participant Flow|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
904989|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
904990|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
904991|NCT01075347|O2|Outcome|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
904992|NCT01075347|O1|Outcome|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
904993|NCT01075347|E2|Reported Event|Non-autologous Serum Use|Patients treated with traditional medication after diabetic vitrectomy or penetrating keratoplasty
904994|NCT01075347|E1|Reported Event|Autologous Serum Use|Patients treated with autoserum after diabetic vitrectomy or penetrating keratoplasty
904995|NCT01075282|B4|Baseline|Total|Total of all reporting groups
904996|NCT01075282|B3|Baseline|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905080|NCT01075256|B4|Baseline|Total|Total of all reporting groups
917356|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
904998|NCT01075282|B1|Baseline|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
904999|NCT01075282|P3|Participant Flow|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905000|NCT01075282|P2|Participant Flow|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905001|NCT01075282|P1|Participant Flow|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905002|NCT01075282|O1|Outcome|LY2189265 1.5 mg and 0.75 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg) or 0.75 mg, subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905003|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905004|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905005|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905006|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905007|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905008|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905009|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905010|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905011|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905012|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905014|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905015|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905016|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905017|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905018|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905019|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905020|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905021|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905022|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905023|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905024|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905025|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905026|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905027|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905028|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905029|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905030|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905031|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905032|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905033|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905034|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905035|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905036|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905037|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905038|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905039|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905040|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905041|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905042|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905043|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905044|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905045|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905046|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905047|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905048|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905049|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905050|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905051|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905052|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905053|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905054|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905055|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905056|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905057|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905058|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905059|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905060|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905061|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905062|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905063|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905064|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905065|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905066|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905067|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905068|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905069|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905070|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905071|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905072|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905073|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905074|NCT01075282|O3|Outcome|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905075|NCT01075282|O2|Outcome|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905076|NCT01075282|O1|Outcome|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905077|NCT01075282|E3|Reported Event|Insulin Glargine|"Insulin Glargine: dose titration based on blood glucose measures, subcutaneous (SC), once daily for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905078|NCT01075282|E2|Reported Event|LY2189265 0.75 mg|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905079|NCT01075282|E1|Reported Event|LY2189265 1.5 mg|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 78 weeks~Metformin: at least 1500 milligram per day (mg/day), oral, for 78 weeks~Glimepiride: at least 4 mg/day, oral, for 78 weeks"
905081|NCT01075256|B3|Baseline|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905082|NCT01075256|B2|Baseline|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905083|NCT01075256|B1|Baseline|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905084|NCT01075256|P3|Participant Flow|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905085|NCT01075256|P2|Participant Flow|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905086|NCT01075256|P1|Participant Flow|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905087|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905088|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905089|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905090|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905091|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905092|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905093|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905094|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905095|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905096|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate (NovaMin) free placebo toothpaste. All study treatments were fluoride free.
905163|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905097|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905098|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905099|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905100|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905101|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905102|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905103|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905104|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905105|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905106|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905107|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905108|NCT01075256|O3|Outcome|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905109|NCT01075256|O2|Outcome|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905110|NCT01075256|O1|Outcome|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905111|NCT01075256|E3|Reported Event|Placebo Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with a sodium calcium phosphosilicate free placebo toothpaste. All study treatments were fluoride free.
905112|NCT01075256|E2|Reported Event|5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905113|NCT01075256|E1|Reported Event|7.5% Sodium Calcium Phosphosilicate Toothpaste|Participants brushed their teeth for two minutes, twice daily for 15 days with 7.5% sodium calcium phosphosilicate toothpaste. All study treatments were fluoride free.
905114|NCT01075243|B4|Baseline|Total|Total of all reporting groups
905115|NCT01075243|B3|Baseline|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905116|NCT01075243|B2|Baseline|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905117|NCT01075243|B1|Baseline|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905118|NCT01075243|P3|Participant Flow|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905119|NCT01075243|P2|Participant Flow|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905120|NCT01075243|P1|Participant Flow|Paracetamol Caplet 1000 Milligrams (mg)|Participants were administered with two paracetamol fast dissolving (FD) 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 milliliter (mL) of water through oral route.
905121|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905122|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905123|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905124|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905125|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905126|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905127|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905128|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
917303|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
905129|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905130|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905131|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905132|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905133|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905134|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905135|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905136|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905137|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905138|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905139|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905140|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905141|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905142|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905143|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
906886|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
905144|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905145|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905146|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905147|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905148|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905149|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905150|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905151|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905152|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905153|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905154|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905155|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905156|NCT01075243|O1|Outcome|Paracetamol Caplet 1000 mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905157|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905158|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905159|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905160|NCT01075243|O3|Outcome|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905161|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905162|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route
905164|NCT01075243|O2|Outcome|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905165|NCT01075243|O1|Outcome|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905166|NCT01075243|E3|Reported Event|Placebo Caplet|Participants were administered with two standard and two FD placebo caplets, with 150 mL of water through oral route.
905167|NCT01075243|E2|Reported Event|Paracetamol Caplet 650 mg|Participants were administered with two standard paracetamol 325 mg caplets (Total dose = 650 mg) and two placebo FD caplets, with 150 mL of water through oral route.
905168|NCT01075243|E1|Reported Event|Paracetamol Caplet 1000mg|Participants were administered with two paracetamol FD 500 mg caplets (Total dose= 1000 mg), and two placebo standard paracetamol caplets with 150 mL of water through oral route.
905169|NCT01075217|B3|Baseline|Total|Total of all reporting groups
905170|NCT01075217|B2|Baseline|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905171|NCT01075217|B1|Baseline|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905172|NCT01075217|P2|Participant Flow|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905173|NCT01075217|P1|Participant Flow|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905174|NCT01075217|O2|Outcome|Visipaque 270 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905175|NCT01075217|O1|Outcome|Isovue 250 Quality of Opacification After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905176|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905177|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905178|NCT01075217|O2|Outcome|Visipaque 270 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905179|NCT01075217|O1|Outcome|Isovue 250 Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905180|NCT01075217|O2|Outcome|Visipaque 270 VAS Score Immedicately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905181|NCT01075217|O1|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905182|NCT01075217|O4|Outcome|Visipaque 270 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905183|NCT01075217|O3|Outcome|Visipaque 270 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905184|NCT01075217|O2|Outcome|Isovue 250 VAS Score Immediately After Injection|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905185|NCT01075217|O1|Outcome|Isovue 250 VAS Score Prior to Injection (Baseline)|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905186|NCT01075217|E2|Reported Event|Visipaque 270|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905260|NCT01075100|P1|Participant Flow|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
917304|NCT01037244|O4|Outcome|Placebo|Placebo tablets
905187|NCT01075217|E1|Reported Event|Isovue 250|Intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
905188|NCT01075204|B1|Baseline|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905189|NCT01075204|P1|Participant Flow|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905190|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905191|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905192|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905193|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905194|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905195|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905196|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905197|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
907360|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
905198|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905199|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905200|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905201|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905202|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905203|NCT01075204|O1|Outcome|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905204|NCT01075204|E1|Reported Event|Clarithromycin Modified Release|Participants with upper or lower respiratory tract infection were administered clarithromycin modified release 500 mg once daily for 7 days and then followed for a further 3 days, per routine clinical practice.
905205|NCT01075191|B1|Baseline|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
905206|NCT01075191|P1|Participant Flow|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
905207|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
905208|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
905209|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
905210|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
905211|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
917305|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
905212|NCT01075191|O1|Outcome|HIV-infected Participants|"HIV-infected participants taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily)."
905213|NCT01075191|E1|Reported Event|HIV-infected Participants|"HIV-infected patients taking lopinavir/ritonavir (Kaletra) and one other protease inhibitor.~Lopinavir/ritonavir (Kaletra) dosing and administration according to the Summary of Product Characteristics (3 capsules twice daily or 2 tablets twice daily).~Safety data presents all enrolled participants, including 5 protocol violations."
905214|NCT01075178|B3|Baseline|Total|Total of all reporting groups
905215|NCT01075178|B2|Baseline|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
905216|NCT01075178|B1|Baseline|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
905217|NCT01075178|P2|Participant Flow|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
905218|NCT01075178|P1|Participant Flow|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
905219|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
905220|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
905221|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
905222|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
905223|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
905224|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
905225|NCT01075178|O2|Outcome|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
905226|NCT01075178|O1|Outcome|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
905227|NCT01075178|E2|Reported Event|Non-palivizumab-treated Subjects (CONTROLS)|HSCHD infants, <2 yrs old that did not receive palivizumab
905228|NCT01075178|E1|Reported Event|Palivizumab-treated Subjects (CASES)|HSCHD infants, <2 yrs old at first dose of palivizumab
905229|NCT01075152|B3|Baseline|Total|Total of all reporting groups
905230|NCT01075152|B2|Baseline|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/- 1 week)
907361|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
905232|NCT01075152|P2|Participant Flow|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis diagnosis (+/1 week)
905233|NCT01075152|P1|Participant Flow|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal diagnosis
905234|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905235|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905236|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905237|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905238|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905239|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905240|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905241|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis]
905242|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905243|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905244|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905245|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905246|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905247|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905248|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905249|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905250|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905251|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905252|NCT01075152|O2|Outcome|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week).
905253|NCT01075152|O1|Outcome|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905254|NCT01075152|E2|Reported Event|Deferred HIV Therapy|HIV therapy initiated at 5 weeks after cryptococcal meningitis (+/- 1 week)
905255|NCT01075152|E1|Reported Event|Earlier HIV Therapy|HIV therapy initiated at 7-13 days after cryptococcal meningitis diagnosis
905256|NCT01075100|B3|Baseline|Total|Total of all reporting groups
905257|NCT01075100|B2|Baseline|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905258|NCT01075100|B1|Baseline|Triple Negative|ER-/PR-/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905259|NCT01075100|P2|Participant Flow|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905261|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905262|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905263|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905264|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905265|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who receive Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905266|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905267|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905268|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905269|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905270|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905271|NCT01075100|O2|Outcome|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905272|NCT01075100|O1|Outcome|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905273|NCT01075100|E2|Reported Event|HR Positive|ER+/PR+/HER2-, or ER+/PR-/HER2-, or ER-/PR+/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905274|NCT01075100|E1|Reported Event|Triple Negative|ER-/PR-/HER2- patients who received Ixabepilone 20 mg/m2 on Days 1 and 8 and Carboplatin AUC=2.5 on Days 1 and 8 of each 21-day cycle.
905275|NCT01075087|B3|Baseline|Total|Total of all reporting groups
905380|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
917357|NCT01037218|O4|Outcome|Placebo|Placebo tablets
905276|NCT01075087|B2|Baseline|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
905277|NCT01075087|B1|Baseline|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
905278|NCT01075087|P2|Participant Flow|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
905279|NCT01075087|P1|Participant Flow|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
905280|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
905281|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
905282|NCT01075087|O2|Outcome|Active Comparator|"(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.~(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.: (study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side."
905283|NCT01075087|O1|Outcome|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
905284|NCT01075087|E2|Reported Event|Active Comparator|(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
905285|NCT01075087|E1|Reported Event|Placebo|"(control group) will receive sterile normal saline in the block~Placebo: Bilateral TAP block using sterile normal saline."
905286|NCT01075074|B4|Baseline|Total|Total of all reporting groups
905287|NCT01075074|B3|Baseline|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
905288|NCT01075074|B2|Baseline|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
905289|NCT01075074|B1|Baseline|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
905290|NCT01075074|P3|Participant Flow|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
905291|NCT01075074|P2|Participant Flow|Normal Saline|Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline
905292|NCT01075074|P1|Participant Flow|Ropivacaine 0.05%|Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine
905293|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
905294|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
905295|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
905296|NCT01075074|O3|Outcome|Ropivacaine 0.25%|Ropivicaine 0.25% group will receive a bilateral transversus abdominis plane block using 15 cc of 0.25% ropivacaine on each side
905297|NCT01075074|O2|Outcome|Normal Saline|Normal saline group will receive a bilateral transversus abdominis plane block 15 cc of sterile normal saline.
905298|NCT01075074|O1|Outcome|Ropivacaine 0.5%|Ropivacaine 0.5% group will receive a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
905299|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
905300|NCT01075074|O2|Outcome|Normal Saline|The normal saline group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
905301|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
905302|NCT01075074|O3|Outcome|Ropivacaine 0.25%|The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
905303|NCT01075074|O2|Outcome|Normal Saline|The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
905304|NCT01075074|O1|Outcome|Ropivacaine 0.5%|The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
905305|NCT01075074|E3|Reported Event|Ropivacaine 0.25%|Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
905306|NCT01075074|E2|Reported Event|Normal Saline|Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
905307|NCT01075074|E1|Reported Event|Ropivacaine 0.5%|Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine
905308|NCT01074944|B1|Baseline|All Participants|All participants who received treatment in LIP (eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks [except for the participants in Japan]. Participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID [50 or 100 mg capsules] based on their individual PK data for up to 78 weeks) and assessed for randomization.
905309|NCT01074944|P5|Participant Flow|ETP, Eliglustat|All participants who did not meet all the randomization criteria at Week 78 of the LIP continued in the ETP and received eliglustat capsules at the same dose as they were receiving at the end of LIP till the end of the study.
905345|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905381|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
905310|NCT01074944|P4|Participant Flow|LTTP, Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905311|NCT01074944|P3|Participant Flow|PAP, Eliglustat: Twice Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP, received eliglustat at the TDD 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905312|NCT01074944|P2|Participant Flow|PAP, Eliglustat: Once Daily|All participants who were randomized after meeting all randomization criteria (defined as: no more than 1 bone crisis and was free of other clinically symptomatic bone disease [such as bone pain attributable to osteonecrosis and/or pathological fractures) during the first 6 months of the LIP; mean hemoglobin level of ≥11 g/dL [if female] and ≥12 g/dL [if male]; mean platelet count ≥100,000/mm^3; spleen volume ≤10 times of normal; liver volume ≤1.5 times of normal; had a dose of 50 mg BID or 100 mg BID of eliglustat for at least 4 months and a peak (2-hour) Genz-99067 plasma concentration of <50 ng/mL) after either 26, 52 or 78 weeks of LIP received eliglustat capsules at the total daily dose (TDD) of 100 mg or 200 mg (the TDD they were on before randomization) once daily (QD) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905313|NCT01074944|P1|Participant Flow|LIP, Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual pharmacokinetics (PK) data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905314|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905335|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905336|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905511|NCT01074229|O1|Outcome|Placebo|Group B (control group) will receive sterile normal saline.
905315|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905316|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905346|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905347|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905382|NCT01074658|O1|Outcome|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
905317|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905318|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905319|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905320|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905321|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905337|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905338|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905512|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
905322|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905323|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905324|NCT01074944|O1|Outcome|LTTP: Eliglustat|All participants who entered PAP continued their blinded randomized treatment for first 4 weeks. Participants who at Week 52 of PAP maintained their therapeutic goals (defined as: no more than 2 bone crisis during PAP [with no more than 1 bone crisis during either first 6 months or later 6 months of PAP] and is free of other clinically symptomatic bone disease during PAP; hemoglobin level not decreased by >1.5 g/dL from Baseline for PAP [defined as last available assessment prior to randomization]; platelet count not decreased by >25% from Baseline for PAP; spleen volume not increased by 25% from Baseline for PAP; liver volume not increased by >20% from Baseline for PAP), continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) QD till the end of the study. The participants who did not maintain all their therapeutic goals continued into the LTTP and received their TDD of eliglustat (100 mg or 200 mg) BID till the end of the study.
905325|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905326|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905327|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905328|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905329|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905330|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg, twice daily (BID) on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905331|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905332|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905333|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905334|NCT01074944|O1|Outcome|LIP: Eliglustat|All participants (except in Japan) received eliglustat 50 mg BID on Day 1 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks. All participants in Japan received eliglustat 50 mg once only on Day 1 and then eliglustat 50 mg BID from Day 2 titrated up to 100 mg BID (50 or 100 mg capsules) based on their individual PK data for up to 78 weeks.
905513|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|STUDY DRUG Group A (study group) 20 cc of 0.5% ropivacaine
905339|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905340|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905341|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905342|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905343|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905344|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905379|NCT01074658|P1|Participant Flow|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
917358|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
905348|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905349|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905350|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905351|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905352|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905353|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905354|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905355|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905356|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905357|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905358|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905359|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905360|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905361|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905362|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905363|NCT01074944|O2|Outcome|PAP, Eliglustat: Twice Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat 50 mg BID or 100 mg BID (the TDD they were on before randomization) from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905409|NCT01074463|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
905364|NCT01074944|O1|Outcome|PAP, Eliglustat: Once Daily|All participants who were randomized after either 26, 52 or 78 weeks of LIP received eliglustat at the TDD of 100 mg or 200 mg (the TDD they were on before randomization) QD from Day 1 up to Week 52 in PAP (50 or 100 mg capsules).
905365|NCT01074944|E1|Reported Event|Eliglustat|All participants who received eliglustat at the TDD of 100 mg or 200 mg in the LIP, PAP, LTTP or ETP.
905366|NCT01074931|B1|Baseline|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
905367|NCT01074931|P1|Participant Flow|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
905368|NCT01074931|O2|Outcome|Lopinavir/Ritonavir Group: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
905369|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
905370|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
905371|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
905372|NCT01074931|O1|Outcome|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
905373|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
905374|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
905375|NCT01074931|O2|Outcome|Lopinavir/Ritonavir: Treatment-experienced|The subgroup of participants who had previously received antiretroviral drug therapy.
905376|NCT01074931|O1|Outcome|Lopinavir/Ritonavir: Treatment-naive|The subgroup of participants who had not received prior antiretroviral drug therapy.
905377|NCT01074931|E1|Reported Event|Lopinavir/Ritonavir Group|Adult participants with HIV-1 infection taking lopinavir/ritonavir
905378|NCT01074658|B1|Baseline|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System.
907362|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
905383|NCT01074658|E1|Reported Event|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation (TAVI) with the Medtronic CoreValve System
905384|NCT01074554|B3|Baseline|Total|Total of all reporting groups
905385|NCT01074554|B2|Baseline|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
905386|NCT01074554|B1|Baseline|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
905387|NCT01074554|P2|Participant Flow|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
905388|NCT01074554|P1|Participant Flow|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
905389|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
905390|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
905391|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
905392|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
905393|NCT01074554|O2|Outcome|Placebo Regimen|The placebo regimen consists of Lactose tablets, one for each antibiotic with equivalent pills
905394|NCT01074554|O1|Outcome|Antibiotic Regimen|"The Antibiotic Regimen consists of Levaquin 750 mg loading on day 1, then 500 mg po QD and Ethambutol 15-25 mg/kg for a maximum of 1200mg QD and Azithromycin 500mg on day 1, then 250 mg po QD and Rifampin 5-10 mg/kg for a maximum of 300mg po QD.~All four drugs are given concomitantly."
905395|NCT01074554|E2|Reported Event|Lactose Tablets|Patients who are randomized to control arm will receive an equivalent number of lactose tablets.
905396|NCT01074554|E1|Reported Event|Antibiotics|This study will compare the effects of antibiotics or placebo on resolution of cutaneous sarcoidosis lesions.
905397|NCT01074502|B1|Baseline|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905398|NCT01074502|P1|Participant Flow|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905399|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905400|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905401|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905402|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905403|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905404|NCT01074502|O1|Outcome|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905405|NCT01074502|E1|Reported Event|Apremilast|apremilast 20 mgs twice a day for 12 weeks
905406|NCT01074463|B3|Baseline|Total|Total of all reporting groups
905407|NCT01074463|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
905408|NCT01074463|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
917306|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
905410|NCT01074463|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
905411|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
905412|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
905413|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
905414|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
905415|NCT01074463|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
905416|NCT01074463|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
905417|NCT01074463|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
905418|NCT01074463|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
905419|NCT01074450|B3|Baseline|Total|Total of all reporting groups
905420|NCT01074450|B2|Baseline|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
905421|NCT01074450|B1|Baseline|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
905422|NCT01074450|P2|Participant Flow|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
905423|NCT01074450|P1|Participant Flow|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
905424|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
905425|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
905426|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
905427|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
905428|NCT01074450|O2|Outcome|Reference (Mirapex®)|0.25 mg Mirapex® Tablets reference product dosed in either period.
905429|NCT01074450|O1|Outcome|Test (Pramipexole Dihydrochloride)|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in either period.
905430|NCT01074450|E2|Reported Event|Reference (Mirapex®) First|0.25 mg Mirapex® Tablets reference product dosed in first period followed by 0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in the second period.
905431|NCT01074450|E1|Reported Event|Test (Pramipexole Dihydrochloride) First|0.25 mg Pramipexole Dihydrochloride Tablets test product dosed in first period followed by 0.25 mg Mirapex® Tablets reference product dosed in the second period.
905432|NCT01074437|B3|Baseline|Total|Total of all reporting groups
905433|NCT01074437|B2|Baseline|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
905434|NCT01074437|B1|Baseline|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
905435|NCT01074437|P2|Participant Flow|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
905436|NCT01074437|P1|Participant Flow|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
905437|NCT01074437|O2|Outcome|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
905438|NCT01074437|O1|Outcome|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
905510|NCT01074229|O2|Outcome|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
905439|NCT01074437|E2|Reported Event|Group B: Corticosteroid With Propranolol|Group B will receive oral liquid prednisolone, and oral propranolol. As in Group A, the dose of prednisolone will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. Oral liquid propranolol will be dosed at 2 mg/kg/day, following initiation in the Cardiology Clinic. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone.
905440|NCT01074437|E1|Reported Event|Group A: Corticosteroid With Placebo|Group A will receive oral, liquid Prednisolone, which is the standard corticosteroid that we use here at Seattle Children's, and oral liquid placebo. The dose of prednisolone that Group A will receive will be 1-2mg/kg/day for 7 days and then the dose will be slowly reduced and then stopped after 3 weeks. This is a standard dose for IH treatment. Gastric prophylaxis (Zantac) will be given to help prevent any stomach problems associated with prednisolone. This treatment will be given for two months, as is our standard practice.
905441|NCT01074307|B3|Baseline|Total|Total of all reporting groups
905442|NCT01074307|B2|Baseline|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905443|NCT01074307|B1|Baseline|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905444|NCT01074307|P2|Participant Flow|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905445|NCT01074307|P1|Participant Flow|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905556|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
905446|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905447|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905448|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905449|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905450|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905451|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905452|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905453|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905454|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905455|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
917307|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
905456|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905457|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905458|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905459|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905460|NCT01074307|O2|Outcome|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905461|NCT01074307|O1|Outcome|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905524|NCT01074164|B1|Baseline|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905462|NCT01074307|E2|Reported Event|High Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose was subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905463|NCT01074307|E1|Reported Event|Low Dose Bisoprolol|Bisoprolol tablet (Concor) administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose was further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and was administered up to 26 weeks, only if the previous administered dose was well tolerated. If the participant didn't tolerate the increased dose, then the last tolerated dose was maintained up to 26 weeks.
905464|NCT01074268|B3|Baseline|Total|Total of all reporting groups
905465|NCT01074268|B2|Baseline|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905466|NCT01074268|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905467|NCT01074268|P2|Participant Flow|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905468|NCT01074268|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905469|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905470|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905471|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905472|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905473|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905474|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905475|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905476|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905477|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905478|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905479|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905480|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905481|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905482|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905483|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905484|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905552|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
905485|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905486|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905487|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905488|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905489|NCT01074268|O2|Outcome|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905490|NCT01074268|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905491|NCT01074268|E2|Reported Event|IDet OD|Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905492|NCT01074268|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin. IDeg OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
905493|NCT01074255|B1|Baseline|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
905494|NCT01074255|P1|Participant Flow|Korean Participants Treated With EMEND (Aprepitant)|EMEND (125 mg oral capsules) is administered 1 hour prior to chemotherapy on Treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
905495|NCT01074255|O1|Outcome|Participants Treated With EMEND|
905496|NCT01074255|E1|Reported Event|Participants in the Safety Analysis|Participants included in the Safety Analysis
905497|NCT01074242|B1|Baseline|Rotateq|Korean infants vaccinated with Rotateq in usual practice
905498|NCT01074242|P1|Participant Flow|Rotateq|Korean infants vaccinated with Rotateq in usual practice
905499|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
905500|NCT01074242|O1|Outcome|Rotateq|Korean infants vaccinated with Rotateq in usual practice
905501|NCT01074242|E1|Reported Event|Rotateq|Korean infants vaccinated with Rotateq in usual practice
905502|NCT01074229|B4|Baseline|Total|Total of all reporting groups
905503|NCT01074229|B3|Baseline|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
905504|NCT01074229|B2|Baseline|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
905505|NCT01074229|B1|Baseline|Placebo|Group B (control group) will receive sterile normal saline.
905506|NCT01074229|P3|Participant Flow|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
905507|NCT01074229|P2|Participant Flow|20 cc of 0.5% Ropivacaine|Group A (study group) 20 cc of 0.5% ropivacaine
905508|NCT01074229|P1|Participant Flow|Placebo|Group B (control group) will receive sterile normal saline.
905509|NCT01074229|O3|Outcome|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
905514|NCT01074229|O1|Outcome|PLACEBO|Group B (control group) will receive sterile normal saline.
905515|NCT01074229|E3|Reported Event|20 cc of 0.25% Ropivacaine|Active Comparator 2. 20 cc of 0.25% ropivacaine
905516|NCT01074229|E2|Reported Event|Study Drug|Group A (study group) 20 cc of 0.5% ropivacaine
905517|NCT01074229|E1|Reported Event|Placebo|Group B (control group) will receive sterile normal saline.
905518|NCT01074216|B1|Baseline|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
905519|NCT01074216|P1|Participant Flow|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
905520|NCT01074216|O1|Outcome|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
905521|NCT01074216|E1|Reported Event|All Patients|Stage IV colorectal cancer patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
905522|NCT01074164|B3|Baseline|Total|Total of all reporting groups
905523|NCT01074164|B2|Baseline|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905553|NCT01074125|O3|Outcome|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
905525|NCT01074164|P2|Participant Flow|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905526|NCT01074164|P1|Participant Flow|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905527|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905528|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905529|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905530|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905531|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905532|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905533|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905534|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905535|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905536|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905537|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905538|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905587|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905539|NCT01074164|O2|Outcome|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905540|NCT01074164|O1|Outcome|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905541|NCT01074164|E2|Reported Event|Accu-patch Pellet|This group of subjects followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids. Additionally, they used a titanium pellet (accu-patch pellet) to self-apply pressure at the LI11 acupuncture pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times weekly for 1 month.
905542|NCT01074164|E1|Reported Event|Control Group|This group of subjects served as the control group and followed a standard-of-care treatment regimen for AD, including the use of moisturizers and topical corticosteroids.
905543|NCT01074125|B4|Baseline|Total|Total of all reporting groups
905544|NCT01074125|B3|Baseline|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
905545|NCT01074125|B2|Baseline|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
905546|NCT01074125|B1|Baseline|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
905547|NCT01074125|P3|Participant Flow|8 g/Day|8 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
905548|NCT01074125|P2|Participant Flow|6 g/Day|6 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
905549|NCT01074125|P1|Participant Flow|1 g/Day|1 g/day KRX-0502 (ferric citrate) taken within 1 hour of meals or snacks daily for 28 days
905550|NCT01074125|O3|Outcome|8 g/Day|"8 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
905551|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
905557|NCT01074125|O2|Outcome|6 g/Day|"6 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
905558|NCT01074125|O1|Outcome|1 g/Day|"1 g/day KRX-0502 (ferric citrate)~ferric citrate: 1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days"
905559|NCT01074125|E3|Reported Event|8g/Day|Participants received 8g tablet of KRX-0502 (ferric citrate) for 4 weeks
905560|NCT01074125|E2|Reported Event|6g/Day|Participants received 6g tablet of KRX-0502 (ferric citrate) for 4 weeks
905561|NCT01074125|E1|Reported Event|1g/Day|Participants received 1g tablet of KRX-0502 (ferric citrate) for 4 weeks
905562|NCT01074099|B3|Baseline|Total|Total of all reporting groups
905563|NCT01074099|B2|Baseline|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
905564|NCT01074099|B1|Baseline|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
905565|NCT01074099|P2|Participant Flow|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
905566|NCT01074099|P1|Participant Flow|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
905567|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
905568|NCT01074099|O1|Outcome|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
905569|NCT01074099|O2|Outcome|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
905570|NCT01074099|O1|Outcome|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
905571|NCT01074099|E2|Reported Event|BMAC Enhanced CABG|"Injection of concentrated bone marrow nucleated cells (BMAC) as an adjunct to CABG surgery~BMAC: Injection of BMAC into ischemic myocardium during CABG"
905572|NCT01074099|E1|Reported Event|Control|"CABG only~CABG only: Control subjects will undergo CABG surgery without BMAC injection"
905573|NCT01074047|B3|Baseline|Total|Total of all reporting groups
905574|NCT01074047|B2|Baseline|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed.~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905575|NCT01074047|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
917308|NCT01037244|E4|Reported Event|Placebo|Placebo tablets
905576|NCT01074047|P2|Participant Flow|Conventional Care Regimens (CCR)|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905577|NCT01074047|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physicians discretion.
905578|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905579|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905603|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905655|NCT01074008|B8|Baseline|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905580|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905581|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905582|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905583|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905584|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905585|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905586|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905588|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905589|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905590|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905591|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
907363|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
905592|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905593|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905594|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905595|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905596|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905597|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905598|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
906314|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
905599|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905600|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905601|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905602|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905604|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905605|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905606|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905607|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905608|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905609|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905621|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905646|NCT01074047|E2|Reported Event|Conventional Care Regimen #3 Best Supportive Care Only|Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
905835|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
905610|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905611|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905612|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905613|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905786|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905614|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905615|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905616|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905617|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905618|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905619|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905620|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
906315|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
905622|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905623|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905624|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905625|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905626|NCT01074047|O4|Outcome|Conventional Care Regimen #1 Intensive Chemotherapy|Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1). Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion.
905627|NCT01074047|O3|Outcome|Conventional Care Regimen #2 Low-dose Cytarabine|Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
905628|NCT01074047|O2|Outcome|Conventional Care Regimen #3 Best Supportive Care Only|Best supportive care included red blood cell (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic and/or antifungal therapy, and nutritional support.
905629|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physicians discretion.
905630|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905631|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905632|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905633|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905645|NCT01074047|E3|Reported Event|Conventional Care Regimen #2 Low-dose Cytarabine|Low-dose cytarabine 20 mg SC injection twice a day (BID) for 10 days, every 28 days (optimally for at least 4 cycles) until the end of the study, unless participants were discontinued from the treatment. Best supportive care as needed, including antibiotics and transfusions, per physicians discretion.
905634|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905635|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905636|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905637|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905638|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905639|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905640|NCT01074047|O2|Outcome|Conventional Care Regimen|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905641|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905642|NCT01074047|O2|Outcome|Conventional Care Regimens|"CCRs included:~1 Intensive Chemotherapy: Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (CIVI) for 7 days and daunorubicin 45 to 60 mg/m^² daily (QD) IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV QD for 3 days. Consolidation Therapy (Cycle 2 and 3) = Cytarabine 100-200 mg/m^2 as a CIVI for 3 to 7 days and daunorubicin 45 to 60 mg/m^² QD or Idarubicin 9-12 mg/m^² IV QD on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from start of induction therapy, upon recovery of absolute neutrophil count (ANC) above 1.0 x 10^9/L and platelets above 75 x 10^9/L. The second cycle started between Day 28 and Day 70 from start of first consolidation therapy. Best supportive care (BSC) of antibiotics and transfusions, were given as needed~2 Low-dose cytarabine 20 mg subcutaneously twice a day (BID) for 10 days every 28 days, plus BSC~3 BSC only = transfusion of blood products, antibiotics, antifungals and nutritional help"
905643|NCT01074047|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2/day subcutaneously [SC] for 7 days every 28 days, allowing for a rest period of 21 days (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and transfusions, per investigator discretion.
905644|NCT01074047|E4|Reported Event|Conventional Care Regimen #1 Intensive Chemotherapy|"Induction Therapy included Cytarabine 100-200 mg/m^2 as a continuous intravenous infusion (IV) for 7 days plus daunorubicin 45 to 60 mg/m^² daily IV on Days 1, 2 and 3 or Idarubicin 9-12 mg/m^² IV daily for 3 days as an alternative to daunorubicin (Cycle 1).~Consolidation Therapy (Cycle 2 and 3) Cytarabine 100-200 mg/m^2 as a continuous IV infusion for a total of 3 to 7 days plus daunorubicin 45 to 60 mg/m^² daily or Idarubicin 9-12 mg/m^² IV daily on Days 1 and 2. The first consolidation therapy started between Day 28 and Day 70 from commencement of induction therapy, upon recovery of absolute neutrophil count (ANC) to at least 1.0 x 10^9/L and platelets to at least 75 x 10^9/L. The second consolidation cycle, if given, started between Day 28 and Day 70 from commencement of the first consolidation therapy. Participants could receive BSC as needed, including antibiotics and transfusions, physicians discretion."
906316|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
905647|NCT01074047|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2/day by subcutaneous injection [SC] for 7 days every 28 days, with a 21 day rest period (optimally for at least 6 cycles) plus best supportive care as needed, including antibiotics and blood product transfusions, growth factors, per physician's discretion.
905648|NCT01074034|B1|Baseline|AV Therapy Assessment Group|"AV Therapy Assessment group, Atrial ATP and Atrial Therapy Suite (ATS)~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device~Ventricular tachyarrhythmia rescue shock feature~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
905649|NCT01074034|P1|Participant Flow|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
905650|NCT01074034|O1|Outcome|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
905651|NCT01074034|O1|Outcome|AV Therapy Assessment Group|"appropriate system performance of the atrial and ventricular tachyarrhythmia therapies in the ASSURE device~AV Therapy Assessment-B301 investigational device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device"
905652|NCT01074034|E1|Reported Event|B301 Device|B301 ASSURE Device: Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
905653|NCT01074008|B10|Baseline|Total|Total of all reporting groups
905654|NCT01074008|B9|Baseline|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905787|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905656|NCT01074008|B7|Baseline|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905657|NCT01074008|B6|Baseline|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905658|NCT01074008|B5|Baseline|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905659|NCT01074008|B4|Baseline|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905660|NCT01074008|B3|Baseline|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905661|NCT01074008|B2|Baseline|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905662|NCT01074008|B1|Baseline|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905663|NCT01074008|P9|Participant Flow|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905664|NCT01074008|P8|Participant Flow|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905665|NCT01074008|P7|Participant Flow|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905779|NCT01073943|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905666|NCT01074008|P6|Participant Flow|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905667|NCT01074008|P5|Participant Flow|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905668|NCT01074008|P4|Participant Flow|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905669|NCT01074008|P3|Participant Flow|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905670|NCT01074008|P2|Participant Flow|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905788|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
917359|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
905671|NCT01074008|P1|Participant Flow|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905672|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905673|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905674|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905675|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905676|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905677|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905678|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905679|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905680|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905681|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905836|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
905682|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905683|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905684|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905685|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905686|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905687|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905688|NCT01074008|O4|Outcome|Placebo (Regardless of Dose) + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905689|NCT01074008|O3|Outcome|ABT-333 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-333 monotherapy at each dose level twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905690|NCT01074008|O2|Outcome|ABT-072 (Regardless of Dose) + pegIFN/RBV|Participants received ABT-072 monotherapy at each dose level once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905691|NCT01074008|O1|Outcome|ABT-450/r (Regardless of Dose) + pegIFN/RBV|Participants received ABT-450 and ritonavir (r) monotherapy at each dose level once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905692|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905693|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905694|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905695|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905696|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905697|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905780|NCT01073943|B1|Baseline|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905698|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905699|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905700|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905701|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905702|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905703|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905704|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905705|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905706|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905707|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905708|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905709|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905710|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905711|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905712|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905713|NCT01074008|O2|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905832|NCT01073865|B1|Baseline|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
906317|NCT01072331|E3|Reported Event|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
905714|NCT01074008|O1|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905715|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905716|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905717|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905718|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
907364|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
905719|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905720|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905721|NCT01074008|O3|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905722|NCT01074008|O2|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905723|NCT01074008|O1|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905724|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905725|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905726|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905727|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905728|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905729|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905833|NCT01073865|P2|Participant Flow|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
906318|NCT01072331|E2|Reported Event|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
905730|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905731|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905732|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905733|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905789|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905734|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905735|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905736|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905737|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905738|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905739|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905740|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905741|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905742|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905743|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905744|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905745|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
906319|NCT01072331|E1|Reported Event|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
905746|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905747|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905748|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905749|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
907365|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
905750|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905751|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905752|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905753|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905754|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905755|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905756|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905757|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905758|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905759|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905760|NCT01074008|O9|Outcome|Placebo + pegIFN/RBV|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905761|NCT01074008|O8|Outcome|ABT-333 (800 mg) Twice Daily (BID) + pegIFN/RBV|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905834|NCT01073865|P1|Participant Flow|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
906320|NCT01072201|B3|Baseline|Total|Total of all reporting groups
905762|NCT01074008|O7|Outcome|ABT-333 (400 mg) Twice a Day (BID) + pegIFN/RBV|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905763|NCT01074008|O6|Outcome|ABT-072 (600 mg) Once Daily (QD) + pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905764|NCT01074008|O5|Outcome|ABT-072 (300 mg) Once Daily (QD) + pegIFN/RBV|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905765|NCT01074008|O4|Outcome|ABT-072 (100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905766|NCT01074008|O3|Outcome|ABT-450/r (200/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905767|NCT01074008|O2|Outcome|ABT-450/r (100/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905768|NCT01074008|O1|Outcome|ABT-450/r (50/100 mg) Once Daily (QD) + pegIFN/RBV|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905769|NCT01074008|E9|Reported Event|Placebo + (pegIFN/RBV)|Participants received matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905770|NCT01074008|E8|Reported Event|ABT-333 (800 mg) Twice Daily (BID) + (pegIFN/RBV)|Participants received 800 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905771|NCT01074008|E7|Reported Event|ABT-333 (400 mg) Twice a Day (BID) + (pegIFN/RBV)|Participants received 400 mg ABT-333 monotherapy twice a day for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905772|NCT01074008|E6|Reported Event|ABT-072 (600 mg) Once Daily (QD) + (pegIFN/RBV|Participants received 600 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905773|NCT01074008|E5|Reported Event|ABT-072 (300 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 300 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905774|NCT01074008|E4|Reported Event|ABT-072 (100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-072 monotherapy once daily for 3 days followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905775|NCT01074008|E3|Reported Event|ABT-450/r (200/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 200 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905776|NCT01074008|E2|Reported Event|ABT-450/r (100/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 100 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905777|NCT01074008|E1|Reported Event|ABT-450/r (50/100 mg) Once Daily (QD) + (pegIFN/RBV)|Participants received 50 mg ABT-450 and 100 mg ritonavir (r) monotherapy once daily for 3 days, followed by the addition of pegylated interferon/ribavirin (pegIFN/RBV) for a total of 12 weeks of combination treatment, followed by 36 weeks of pegIFN/RBV alone. Pegylated interferon was dosed at 180 µg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
905778|NCT01073943|B3|Baseline|Total|Total of all reporting groups
906321|NCT01072201|B2|Baseline|Ultrabrite Toothpaste|sodium fluoride control (placebo)
905781|NCT01073943|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905782|NCT01073943|P1|Participant Flow|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905783|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905784|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905785|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
906095|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
905790|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905791|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905792|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905793|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905794|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905795|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905796|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905797|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905798|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905799|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905800|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905801|NCT01073943|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905802|NCT01073943|O1|Outcome|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905803|NCT01073943|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905804|NCT01073943|E1|Reported Event|PicoPrep|"Day Before method and consists of two separate doses: the first dose during the afternoon or early evening before the colonoscopy and the second dose 6 hours later during the evening before the colonoscopy"
905805|NCT01073930|B3|Baseline|Total|Total of all reporting groups
906322|NCT01072201|B1|Baseline|Total Toothpaste|Triclosan/copolymer/Fluoride
905806|NCT01073930|B2|Baseline|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905807|NCT01073930|B1|Baseline|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
905808|NCT01073930|P2|Participant Flow|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905809|NCT01073930|P1|Participant Flow|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905810|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905811|NCT01073930|O1|Outcome|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
905812|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905813|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905814|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
917360|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
905815|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905816|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905817|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905818|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905819|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905820|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905821|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905822|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905823|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905824|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905825|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905826|NCT01073930|O2|Outcome|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905827|NCT01073930|O1|Outcome|PICOPREP|"Split Dose method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy."
905828|NCT01073930|E2|Reported Event|HalfLytely|HalfLytely and Bisacodyl Tablets Bowel Prep Kit was used according to the approved labeled dosage and administration instructions. The two bisacodyl tablets were taken the day prior to the procedure and the HalfLytely was taken following the first bowel movement or 6 hours after the bisacodyl tablets.
905829|NCT01073930|E1|Reported Event|PICOPREP|“Split Dose” method and consists of two separate doses: the first dose during the evening before the colonoscopy and the second dose the next day, during the morning prior to the colonoscopy.
905830|NCT01073865|B3|Baseline|Total|Total of all reporting groups
905831|NCT01073865|B2|Baseline|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
906323|NCT01072201|P2|Participant Flow|Ultrabrite Toothpaste|sodium fluoride control(placebo)
905837|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
905838|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
905839|NCT01073865|O2|Outcome|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
905840|NCT01073865|O1|Outcome|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
905841|NCT01073865|E2|Reported Event|Zoladex 3.6 mg|ZOLADEX 3.6 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 4 weeks
905842|NCT01073865|E1|Reported Event|Zoladex 10.8 mg|ZOLADEX 10.8 mg (goserelin acetate): one subcutaneous depot injection into interior abdominal wall once every 12 weeks
905843|NCT01073657|B3|Baseline|Total|Total of all reporting groups
905844|NCT01073657|B2|Baseline|Active Control|Veterans recived peer services that did not address educational goals
905845|NCT01073657|B1|Baseline|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
905846|NCT01073657|P2|Participant Flow|General Peer Support|Veterans received peer services that did not address educational goals
905847|NCT01073657|P1|Participant Flow|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals
905848|NCT01073657|O2|Outcome|General Peer Support|Matched peer attention no supported education service
905849|NCT01073657|O1|Outcome|Supported Education|Supported Education: Rehabilitation counseling using peers to achieve educational goals Intervention group
905850|NCT01073657|E2|Reported Event|Active Control|Veterans received matched peer attention that did not address educational goals
905851|NCT01073657|E1|Reported Event|Arm 1|Supported Education: Rehabilitation counseling using peers to achieve educational goals
905876|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
906096|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
905852|NCT01073631|B1|Baseline|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
905853|NCT01073631|P1|Participant Flow|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
905854|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
905855|NCT01073631|O1|Outcome|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
905856|NCT01073631|E1|Reported Event|Vfend|Vfend (voriconazole) tablets (recommended dose: 200mg orally every 12hours) or sequential Vfend tablet and IV Vfend (recommended dose: 6mg/kg IV infusion every 12hours for first 24hours [loading dose], 3 to 4mg/kg IV infusion every 12hours [maintenance dose]) treatment (or vice versa) for use as indicated according to approved local product document and adjusted according to medical and therapeutic necessity.
905857|NCT01073618|B1|Baseline|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
905858|NCT01073618|P1|Participant Flow|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
905859|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
905860|NCT01073618|O1|Outcome|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
905861|NCT01073618|E1|Reported Event|Vfend|Vfend (voriconazole) intravenous (IV) for use as indicated according to the approved local product document (LPD) or sequential IV and Vfend tablets treatment (or vice versa) for use as indicated according to approved LPD.
905862|NCT01073605|B4|Baseline|Total|Total of all reporting groups
905863|NCT01073605|B3|Baseline|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905864|NCT01073605|B2|Baseline|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905865|NCT01073605|B1|Baseline|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905866|NCT01073605|P3|Participant Flow|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905867|NCT01073605|P2|Participant Flow|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
917309|NCT01037244|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
905868|NCT01073605|P1|Participant Flow|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905869|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905870|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905871|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905872|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905873|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905874|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905875|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
917361|NCT01037218|O4|Outcome|Placebo|Placebo tablets
905877|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905878|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905879|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905880|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905881|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905882|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905883|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905884|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905885|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905886|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905887|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905888|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905889|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905890|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905891|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905892|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905893|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905894|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905895|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905896|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905897|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905898|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905899|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905900|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905901|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905902|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905903|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905904|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905905|NCT01073605|O3|Outcome|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905906|NCT01073605|O2|Outcome|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905907|NCT01073605|O1|Outcome|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 IU/kg/week (0.03 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905908|NCT01073605|E3|Reported Event|Genotonorm 1.4 (Intermittent Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as an intermittent treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905909|NCT01073605|E2|Reported Event|Genotonorm 1.4 (Continuous Treatment)|Subjects received 1.4 IU/kg/week (0.06 mg/kg/day) of the growth hormone Genotonorm as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905910|NCT01073605|E1|Reported Event|Genotonorm 0.7 (Continuous Treatment)|Subjects received 0.7 international unit (IU)/kilogram (kg)/week (0.03 milligram [mg]/kg/day) of Genotonorm growth hormone (GH) as a continuous treatment. Treatment was allowed to be taken until final height of the subject had been reached.
905911|NCT01073566|B3|Baseline|Total|Total of all reporting groups
905912|NCT01073566|B2|Baseline|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
905913|NCT01073566|B1|Baseline|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
905914|NCT01073566|P2|Participant Flow|Usual Injection Device Then Finesse|Subjects in this group first used their usual pen/syringe to deliver bolus insulin for 6 weeks then switched to Finesse Patch to deliver bolus insulin for the final 6 weeks
905915|NCT01073566|P1|Participant Flow|Finesse Then Usual Injection Device|Subjects in this group first used Finesse Patch to deliver bolus insulin for 6 weeks then switched back to their usual pen/syringe to deliver bolus insulin for the final 6 weeks
905916|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
905917|NCT01073566|O1|Outcome|Finesse|Bolus Patch
905918|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
905919|NCT01073566|O1|Outcome|Finesse|Bolus Patch
905920|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
905921|NCT01073566|O1|Outcome|Finesse|Bolus Patch
905922|NCT01073566|O2|Outcome|Usual Injection Device|Pen/Syringe
905923|NCT01073566|O1|Outcome|Finesse|Bolus Patch
905924|NCT01073566|E2|Reported Event|Usual Injection Device|Pen/Syringe
905925|NCT01073566|E1|Reported Event|Finesse|Bolus Patch
905926|NCT01073462|B1|Baseline|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905927|NCT01073462|P1|Participant Flow|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905928|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
906077|NCT01072877|P5|Participant Flow|Polidocanol Endovenous Microfoam 2.0%|"Polidocanol endovenous microfoam 2.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
905929|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905930|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905931|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905932|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905933|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905934|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905935|NCT01073462|O1|Outcome|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years.
905965|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905936|NCT01073462|E1|Reported Event|Paricalcitol IV|Participants with chronic kidney disease stage 5 with secondary hyperparathyroidism and cardiac morbidity received intravenous (IV) paricalcitol (Zemplar) prescribed according to current practice with regards to dose, population and indication for up to 2 years
905937|NCT01073449|B1|Baseline|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
905938|NCT01073449|P1|Participant Flow|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
905939|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
905940|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
905941|NCT01073449|O1|Outcome|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
905942|NCT01073449|E1|Reported Event|Cardiac Device|All patients implanted with a cardiac device (PM or ICD)
905943|NCT01073293|B3|Baseline|Total|Total of all reporting groups
905944|NCT01073293|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905945|NCT01073293|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905946|NCT01073293|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905947|NCT01073293|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905948|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905949|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905950|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905951|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905952|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905953|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905954|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905955|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905956|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905957|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905958|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905959|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905960|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905961|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905962|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905963|NCT01073293|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
905964|NCT01073293|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
906094|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
905966|NCT01073293|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
905967|NCT01073293|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Repevax™ given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Day 1
905968|NCT01073267|B1|Baseline|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
905969|NCT01073267|P1|Participant Flow|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
905970|NCT01073267|O1|Outcome|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
905971|NCT01073267|E1|Reported Event|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
905972|NCT01073163|B1|Baseline|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905973|NCT01073163|P1|Participant Flow|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905974|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905975|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905976|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905977|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905978|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905979|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905980|NCT01073163|O3|Outcome|Total|All participants administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905981|NCT01073163|O2|Outcome|Mantle Cell Lymphoma|Participants with mantle cell lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905982|NCT01073163|O1|Outcome|Non-Hodgkin Lymphoma|Participants with non-Hodgkin Lymphoma were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905983|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905984|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
905985|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on day 1 of each 28-day cycle.
905986|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905987|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905988|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905989|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905990|NCT01073163|O1|Outcome|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905991|NCT01073163|E1|Reported Event|Bendamustine With Rituximab|Participants were administered bendamustine intravenous (IV) infusion at 90 mg/m^2 on Days 1 and 2 of each 28-day cycle, and rituximab IV infusion at 375 mg/m^2 on Day 1 of each 28-day cycle.
905992|NCT01072929|B4|Baseline|Total|Total of all reporting groups
905993|NCT01072929|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
905994|NCT01072929|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
905995|NCT01072929|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
905996|NCT01072929|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
905997|NCT01072929|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
905998|NCT01072929|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
905999|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906000|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906001|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906002|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906003|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906004|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906005|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906006|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906007|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906008|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906009|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906010|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906011|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906012|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906013|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906014|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906324|NCT01072201|P1|Participant Flow|Total Toothpaste|Triclosan/copolymer/Fluoride
906015|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906016|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906017|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906018|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906019|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906020|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906021|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906022|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906023|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
907366|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
906024|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906025|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906026|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906027|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906028|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906029|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906030|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906031|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906032|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906033|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906034|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906035|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906036|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906037|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906038|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906039|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906040|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906041|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906042|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906043|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906325|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
906044|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906045|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906046|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906047|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906048|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906049|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906050|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906051|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906052|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906053|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906054|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906055|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906056|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906057|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906058|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906059|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906060|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906061|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906062|NCT01072929|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906063|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906064|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906065|NCT01072929|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
906066|NCT01072929|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906067|NCT01072929|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906068|NCT01072929|E3|Reported Event|PLACEBO|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906069|NCT01072929|E2|Reported Event|ARMODAFINIL 200 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906070|NCT01072929|E1|Reported Event|ARMODAFINIL 150 MG|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906071|NCT01072877|B6|Baseline|Total|Total of all reporting groups
906072|NCT01072877|B5|Baseline|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam2.0%
906073|NCT01072877|B4|Baseline|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam 1.0%
906074|NCT01072877|B3|Baseline|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam 0.5%
906075|NCT01072877|B2|Baseline|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam 0.125%
906076|NCT01072877|B1|Baseline|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
906078|NCT01072877|P4|Participant Flow|Polidocanol Endovenous Microfoam 1.0%|"Polidocanol endovenous microfoam 1.0%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
906079|NCT01072877|P3|Participant Flow|Polidocanol Endovenous Microfoam 0.5%|"Polidocanol endovenous microfoam 0.5%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
906080|NCT01072877|P2|Participant Flow|Polidocanol Endovenous Microfoam 0.125%|"Polidocanol endovenous microfoam 0.125%~Polidocanol Endovenous Microfoam (PEM): Injection of Polidocanol Endovenous Microfoam"
906081|NCT01072877|P1|Participant Flow|Vehicle|"Injection of vehicle comparator~Placebo Vehicle: Placebo vehicle"
906082|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
906083|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
906084|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
906085|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
906086|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
906087|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
906088|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at a 1.0% concentration
906089|NCT01072877|O3|Outcome|Polidocanol Injectable Foam 0.5%|Polidocanol injectable foam at a 0.5% concentration
906090|NCT01072877|O2|Outcome|Polidocanol Injectable Foam 0.125%|Polidocanol injectable foam at a 0.125% concentration
906091|NCT01072877|O1|Outcome|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
906092|NCT01072877|O5|Outcome|Polidocanol Injectable Foam 2.0%|Polidocanol injectable foam at a 2.0% concentration
906093|NCT01072877|O4|Outcome|Polidocanol Injectable Foam 1.0%|Polidocanol injectable foam at 1.0% concentration
906097|NCT01072877|E5|Reported Event|Polidocanol Endovenous Microfoam 2.0%|polidocanol injectable foam at a 2.0% concentration
906098|NCT01072877|E4|Reported Event|Polidocanol Injectable Foam 1.0%|polidocanol injectable foam at a 1.0% concentration
906099|NCT01072877|E3|Reported Event|Polidcanol Injectable Foam 0.5%|polidocanol injectable foam at a 0.5% concentration
906100|NCT01072877|E2|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam at a 0.125% concentration
906101|NCT01072877|E1|Reported Event|Vehicle|"Injection of vehicle~Placebo Vehicle: Placebo vehicle"
906102|NCT01072773|B1|Baseline|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906103|NCT01072773|P1|Participant Flow|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906104|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906105|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906106|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906107|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906108|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906109|NCT01072773|O1|Outcome|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906110|NCT01072773|E1|Reported Event|Bortez/Cyc/Dex|Bortezomib IV on days 1, 8, and 15, oral cyclophosphamide and oral dexamethasone once daily on days 1, 8, 15, and 22.
906111|NCT01072669|B3|Baseline|Total|Total of all reporting groups
906112|NCT01072669|B2|Baseline|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
906113|NCT01072669|B1|Baseline|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
906114|NCT01072669|P2|Participant Flow|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
906115|NCT01072669|P1|Participant Flow|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
906116|NCT01072669|O2|Outcome|Sugar Pill|Placebo, same appearing as Ambrisentan
906117|NCT01072669|O1|Outcome|Ambrisentan|Ambrisentan 5 mg daily for 1 month, then 10 mg daily for 2 months
906118|NCT01072669|E2|Reported Event|Sugar Pill|those getting sugar pill to evaluate if the active drug improves digital microvascular flow in limited scleroderma patients
906119|NCT01072669|E1|Reported Event|Ambrisentan|"drug arm~use of ambrisentan in limited scleroderma patients with raynaud's to evaluate digital microvascular flow"
906120|NCT01072656|B3|Baseline|Total|Total of all reporting groups
906121|NCT01072656|B2|Baseline|Sham First|sham stimulation - IPG ON, at 0 Volt
906122|NCT01072656|B1|Baseline|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
906123|NCT01072656|P2|Participant Flow|Sham First|sham stimulation - IPG ON, at 0 Volt
906124|NCT01072656|P1|Participant Flow|Active First|active stimulation programmed to the settings found to be optimal during the titration phase
906162|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906326|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
906327|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
906125|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
906126|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
906127|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
906128|NCT01072656|O2|Outcome|Sham Stimulation|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
906129|NCT01072656|O1|Outcome|Active Stimulation|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
906130|NCT01072656|E3|Reported Event|Phase I-IV|Phase I-IV is time frame of patient consent through surgery just prior to beginning Active v Sham Stimulation Phase.
906131|NCT01072656|E2|Reported Event|Sham Stimulation (Phase V)|"IPG is set to ON but the voltage is set to 0V.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
906132|NCT01072656|E1|Reported Event|Active Stimulation (Phase V)|"Active stimulation and programmed to the settings found to be optimal during the titration process.~Deep Brain Stimulation for Thalamic Pain Syndrome: Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group."
906133|NCT01072643|B1|Baseline|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
906163|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906164|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906134|NCT01072643|P1|Participant Flow|Dexmedetomidine 1 mcg/kg Bolus|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
906135|NCT01072643|O4|Outcome|Subject 4|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
906136|NCT01072643|O3|Outcome|Subject 3|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
906137|NCT01072643|O2|Outcome|Subject 2|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
906138|NCT01072643|O1|Outcome|Subject 1|Pulmonary vascular resistance (PVR) in Wood units calculated during cardiac catheterization
906139|NCT01072643|E1|Reported Event|Dexmedetomidine|"To study safety of DEX with regard to effect on PVR; There will be 3 study groups (n=8 per group). The groups will be based on DEX doses as follows- Group 1 - Bolus 1 mcg/kg followed by infusion 0.7 mcg/kg/hr Group 2 - Bolus 1.5 mcg/kg followed by infusion 1.05 mcg/kg/hr Group 3 - Bolus 2 mcg/kg followed by infusion 1.4 mcg/kg/hr~Dexmedetomidine: This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine."
906140|NCT01072630|B4|Baseline|Total|Total of all reporting groups
906141|NCT01072630|B3|Baseline|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906142|NCT01072630|B2|Baseline|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906143|NCT01072630|B1|Baseline|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906144|NCT01072630|P3|Participant Flow|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906145|NCT01072630|P2|Participant Flow|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906146|NCT01072630|P1|Participant Flow|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906147|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906148|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906149|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906150|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906151|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906152|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906153|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906154|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906155|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906156|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906157|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906158|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906159|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906160|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906161|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906165|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906166|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906167|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906168|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906169|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906170|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906171|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906172|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906173|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906174|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906175|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906176|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906177|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906178|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906179|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906180|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906181|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906182|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906183|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906184|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906185|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906186|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906187|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906188|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906189|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906190|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906191|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906192|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906307|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
906308|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
906193|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906194|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906195|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906196|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906197|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906198|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906199|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906200|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906201|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906202|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
907367|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
906203|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906204|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906205|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906206|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906207|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906208|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906209|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906210|NCT01072630|O3|Outcome|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906211|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906212|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906213|NCT01072630|O3|Outcome|All Armodafinil|This arm combines participants who took 150 mg/day and those in the discontinued treatment arm who took 200 mg/day of armodafinil for 8 weeks.
906214|NCT01072630|O2|Outcome|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906215|NCT01072630|O1|Outcome|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906216|NCT01072630|E3|Reported Event|Placebo|Participants were administered placebo and titrated to match the armodafinil treatment arms. Total treatment was 8 weeks.
906217|NCT01072630|E2|Reported Event|Armodafinil 200 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 200 mg/day. The 200 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment. This treatment arm was discontinued via a protocol amendment.
906218|NCT01072630|E1|Reported Event|Armodafinil 150 mg/Day|Participants started the study at a dose of 50mg/day of armodafinil and titrated up in the first week to 150 mg/day. The 150 mg/day dosage was continued for 7 more weeks for a total of 8 weeks of treatment.
906219|NCT01072617|B1|Baseline|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
906309|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
906310|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
906220|NCT01072617|P1|Participant Flow|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
906221|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
906222|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
906341|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
906342|NCT01072188|E2|Reported Event|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
906223|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
906224|NCT01072617|O1|Outcome|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
906225|NCT01072617|E1|Reported Event|Safety of rTMS in Schizophrenia Patients|"Participants will receive repetitive transcranial magnetic stimulation via MagPro x100 device to the vermis of cerebellum twice a day over 5 days~Transcranial magnetic stimulation via MagPro x100 device: Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
906226|NCT01072539|B1|Baseline|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906227|NCT01072539|P1|Participant Flow|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906228|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906229|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906230|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906231|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906232|NCT01072539|O1|Outcome|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906233|NCT01072539|E1|Reported Event|Tygacil|Participants were administered Tygacil as part of routine practice. The use and dosage recommendations for Tygacil were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
906234|NCT01072526|B1|Baseline|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906311|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
906235|NCT01072526|P2|Participant Flow|Control|Cyclosporin (Restasis)ophthalmic solution; 1 drop both eyes twice daily plus placebo solution. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906236|NCT01072526|P1|Participant Flow|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906237|NCT01072526|O2|Outcome|Control|"Subjects will receive placebo in combination with cyclosporin (Restasis) solution.~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
906238|NCT01072526|O1|Outcome|Intervention|"Subjects will receive Euphrasia-based homeopathic therapy (Artificial Tears) in combination with cyclosporin (Restasis) solution.~Euphrasia-based homeopathic therapy: ophthalmic solution; 1 drop both eyes twice daily~Cyclosporin solution: Ophthalmic solution; 1 drop both eyes twice daily"
906239|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906240|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906241|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906242|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906243|NCT01072526|O2|Outcome|Control|cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906244|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906245|NCT01072526|O2|Outcome|Control|cyclosporin ophthalmic solution plus placebo solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906246|NCT01072526|O1|Outcome|Intervention|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis) ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906247|NCT01072526|E1|Reported Event|2 Arm Study - Description Below|Euphrasia based homeopathic therapy in combination with cyclosporin (Restasis)euphrasia based homeopathic therapy and cyclosporin : ophthalmic solution; 1 drop both eyes twice daily. Participants to undergo 4 measures of dry eyes at baseline and after 6 weeks of therapy: 1) tear film break-up; 2) corneal staining by fluorescein; 3) Shirmer's test; and 4) Ocular Surface Disease Index (OSDI).
906248|NCT01072500|B3|Baseline|Total|Total of all reporting groups
906249|NCT01072500|B2|Baseline|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
906250|NCT01072500|B1|Baseline|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
906251|NCT01072500|P2|Participant Flow|Successful Aging (Health Education)|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
906252|NCT01072500|P1|Participant Flow|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
906253|NCT01072500|O2|Outcome|Successful Aging|"The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.~Successful Aging: The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises."
906254|NCT01072500|O1|Outcome|Physical Activity|"The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.~Physical Activity: The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling."
906255|NCT01072500|O2|Outcome|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
906256|NCT01072500|O1|Outcome|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
906257|NCT01072500|E2|Reported Event|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
906258|NCT01072500|E1|Reported Event|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
906259|NCT01072448|B3|Baseline|Total|Total of all reporting groups
917313|NCT01037218|B4|Baseline|Placebo|Placebo tablets
906260|NCT01072448|B2|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906261|NCT01072448|B1|Baseline|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906262|NCT01072448|P2|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906263|NCT01072448|P1|Participant Flow|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906264|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906343|NCT01072188|E1|Reported Event|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
906344|NCT01072175|B13|Baseline|Total|Total of all reporting groups
907368|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
906265|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906266|NCT01072448|O2|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906267|NCT01072448|O1|Outcome|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906268|NCT01072448|E2|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906269|NCT01072448|E1|Reported Event|Indacaterol 75 μg|Patients inhaled indacaterol 75 μg once daily in the morning between 8:00 AM and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
906270|NCT01072409|B1|Baseline|Implanted|Subjects who met study inclusion and completed the primary endpoint.
906271|NCT01072409|P1|Participant Flow|Implanted|Subjects who met study inclusion and completed the primary endpoint.
906272|NCT01072409|O1|Outcome|Implanted|Subjects who met study inclusion and completed the primary endpoint.
906273|NCT01072409|E1|Reported Event|Implanted|Subjects who met study inclusion and completed the primary endpoint.
906274|NCT01072396|B3|Baseline|Total|Total of all reporting groups
906275|NCT01072396|B2|Baseline|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
906276|NCT01072396|B1|Baseline|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
906277|NCT01072396|P2|Participant Flow|Tiotropium/Placebo|Patients were randomized to receive treatment with Tiotropium 18 micrograms for six weeks followed by treatment with placebo for six weeks
906278|NCT01072396|P1|Participant Flow|Placebo/Tiotropium|Patients were randomized to receive treatment with Placebo for six weeks followed by treatment with Tiotropium 18 micrograms for six weeks
906279|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
906280|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
906281|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
906282|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
906283|NCT01072396|O2|Outcome|Tiotropium|Patients who received tiotropium in period one or period two
906284|NCT01072396|O1|Outcome|Placebo|Patients who received placebo in period one or period two
906285|NCT01072396|E2|Reported Event|Tiotropium|Patients who received tiotropium in period one or period two
906286|NCT01072396|E1|Reported Event|Placebo|Patients who received placebo in period one or period two
906287|NCT01072357|B3|Baseline|Total|Total of all reporting groups
906288|NCT01072357|B2|Baseline|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
906312|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
906313|NCT01072331|O1|Outcome|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
917314|NCT01037218|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
906289|NCT01072357|B1|Baseline|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
906290|NCT01072357|P2|Participant Flow|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
906345|NCT01072175|B12|Baseline|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906346|NCT01072175|B11|Baseline|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906739|NCT01071200|B2|Baseline|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
906291|NCT01072357|P1|Participant Flow|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
906292|NCT01072357|O2|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
906293|NCT01072357|O1|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
906294|NCT01072357|O2|Outcome|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
906295|NCT01072357|O1|Outcome|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
906296|NCT01072357|E2|Reported Event|0.9% NaCl & Refresh Liquigel|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 mL 0.9% sodium chloride (NaCl). Starting Day 1 post-transplant surgery, subjects will begin treatment with topical Refresh Liquigel. Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments (both topical and subconjunctival injection) are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~0.9% NaCl & Refresh Liquigel: One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks"
906297|NCT01072357|E1|Reported Event|Avastin® (Bevacizumab)|"Treatment will begin on Day 0, immediately upon the conclusion of the penetrating keratoplasty procedure with an injection of 0.1 milliliter (mL) (2.5 mg) bevacizumab. Starting Day 1 post-transplant surgery, subjects will begin treatment with topical bevacizumab (1% solution). Topical treatment will be self-administered 4 times a day for 4 weeks.~The study treatments are to be given in addition to standard of care treatments. Also, all patients will follow a standard post-operative follow-up visit schedule.~Avastin® (bevacizumab): One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks."
906298|NCT01072331|B4|Baseline|Total|Total of all reporting groups
906299|NCT01072331|B3|Baseline|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
906300|NCT01072331|B2|Baseline|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
906301|NCT01072331|B1|Baseline|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
906302|NCT01072331|P3|Participant Flow|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
906303|NCT01072331|P2|Participant Flow|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
906304|NCT01072331|P1|Participant Flow|MP-513 10 mg|MP-513 10 mg once a day for 4 weeks
906305|NCT01072331|O3|Outcome|Placebo of MP-513|Placebo of MP-513 a day for 4 weeks
906306|NCT01072331|O2|Outcome|MP-513 20 mg|MP-513 20 mg once a day for 4 weeks
906328|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
906329|NCT01072201|O2|Outcome|Ultrabrite Toothpaste|sodium fluoride control (placebo)
906330|NCT01072201|O1|Outcome|Total Toothpaste|Triclosan/copolymer/Fluoride
906331|NCT01072201|E2|Reported Event|Ultrabrite Toothpaste|sodium fluoride control (placebo)
906332|NCT01072201|E1|Reported Event|Total Toothpaste|Triclosan/copolymer/Fluoride
906333|NCT01072188|B3|Baseline|Total|Total of all reporting groups
906334|NCT01072188|B2|Baseline|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
906335|NCT01072188|B1|Baseline|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
906336|NCT01072188|P2|Participant Flow|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
906337|NCT01072188|P1|Participant Flow|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
906338|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
906339|NCT01072188|O1|Outcome|ProClude Prophylaxis Paste-A|Arginine Bicarbonate prophy paste (experimental).
906340|NCT01072188|O2|Outcome|Nupro-M Prophylaxis Paste-B|Control prophy paste (Fluoride free).
906347|NCT01072175|B10|Baseline|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906348|NCT01072175|B9|Baseline|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906349|NCT01072175|B8|Baseline|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906350|NCT01072175|B7|Baseline|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906351|NCT01072175|B6|Baseline|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906352|NCT01072175|B5|Baseline|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906353|NCT01072175|B4|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906354|NCT01072175|B3|Baseline|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906355|NCT01072175|B2|Baseline|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906356|NCT01072175|B1|Baseline|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
906357|NCT01072175|P13|Participant Flow|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906358|NCT01072175|P12|Participant Flow|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906359|NCT01072175|P11|Participant Flow|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906360|NCT01072175|P10|Participant Flow|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906361|NCT01072175|P9|Participant Flow|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
906362|NCT01072175|P8|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906363|NCT01072175|P7|Participant Flow|Part C (Randomized): Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906364|NCT01072175|P6|Participant Flow|Part C (Randomized): Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906365|NCT01072175|P5|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906366|NCT01072175|P4|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906367|NCT01072175|P3|Participant Flow|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906394|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906395|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906884|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906368|NCT01072175|P2|Participant Flow|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906369|NCT01072175|P1|Participant Flow|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
906370|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906371|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906372|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906373|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906374|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906375|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906376|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906377|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906378|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906379|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906380|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906381|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906382|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906383|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906384|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906385|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906386|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906387|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906500|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906388|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906389|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906390|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906391|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906392|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906393|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
907369|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
906396|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906397|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906398|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906399|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906400|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906401|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906402|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906403|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906404|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906405|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906406|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
906407|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906408|NCT01072175|O2|Outcome|Part C: Trametinib|Participants received Trametinib 1 mg or 2 mg tablets QD.
906409|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906410|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906411|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906412|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906413|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906414|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906415|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906416|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906417|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906418|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906467|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906419|NCT01072175|O1|Outcome|Part B: Dabrafenib + Trametinib|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib (75 mg or 150 mg) gelatin capsules BID and trametinib (1 mg, 1.5 mg, or 2 mg) tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906420|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906421|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906422|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906510|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906423|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906424|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906425|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906426|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906427|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906428|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906429|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906430|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906431|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906432|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906433|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906434|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906435|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906436|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906437|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906438|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906439|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906440|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906441|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906442|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906443|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906444|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906445|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906446|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906447|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906448|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906449|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906450|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906451|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906452|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906453|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906454|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906455|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906456|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906457|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906458|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906459|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906460|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
906461|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906462|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906463|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906464|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906465|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906466|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906499|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906601|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
906468|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906469|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906470|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906471|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906472|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906473|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906474|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906763|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906475|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906476|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906477|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906478|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906479|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906480|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906481|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906482|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906483|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906484|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906485|NCT01072175|O4|Outcome|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906486|NCT01072175|O3|Outcome|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906487|NCT01072175|O2|Outcome|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906488|NCT01072175|O1|Outcome|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906489|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906490|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906491|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906492|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906493|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906494|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906495|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906496|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906497|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906498|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906501|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
906502|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906503|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906504|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906505|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906506|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906507|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906508|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906509|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
917362|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
906511|NCT01072175|O1|Outcome|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
906512|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906513|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906514|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906515|NCT01072175|O3|Outcome|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906516|NCT01072175|O2|Outcome|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906517|NCT01072175|O1|Outcome|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906518|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906519|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906520|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906521|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906522|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906523|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906524|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906525|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906602|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
906603|NCT01072136|O2|Outcome|Placebo|Placebo
906526|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906527|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906528|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906568|NCT01072149|P2|Participant Flow|Sequence 2: Placebo, FF/VI 100/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906885|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
906529|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906530|NCT01072175|O4|Outcome|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906531|NCT01072175|O3|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906532|NCT01072175|O2|Outcome|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906533|NCT01072175|O1|Outcome|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906534|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
906535|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
906536|NCT01072175|O2|Outcome|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
906537|NCT01072175|O1|Outcome|Part A: Dabrafenib 75 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules alone on Day 1.
906538|NCT01072175|E13|Reported Event|Part D: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906539|NCT01072175|E12|Reported Event|Part D: Dabrafenib 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID and trametinib 2 mg tablets QD.
906540|NCT01072175|E11|Reported Event|Part D: Dabrafenib 150 mg to DAB 150 mg + Trametinib 2 mg|Participants received dabrefinib 150 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 150 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906541|NCT01072175|E10|Reported Event|Part D: Dabrafenib (DAB) 75 mg to DAB 75 mg + Trametinib 2 mg|Participants received dabrefinib 75 mg HPMC capsules BID. These participants, after completion of serial PK collection in the first treatment period, were allowed to continue with dabrafenib 75 mg BID and trametinib 2 mg tablets QD as combination dosing starting on Day 29.
906542|NCT01072175|E9|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 2 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD.
906543|NCT01072175|E8|Reported Event|Part C: Dabrafenib 150 mg + Trametinib 1 mg|Participants received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD.
906544|NCT01072175|E7|Reported Event|Part C (Crossover): Dabrafenib 150 mg + Trametinib 2 mg|Participants who received dabrafenib 150 mg capsules BID alone in the Randomized Phase were given the opportunity to receive combination dosing of dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD upon disease progression with approval of the GlaxoSmithKline (GSK) Medical Monitor.
906545|NCT01072175|E6|Reported Event|Part C: Dabrafenib 150 mg|Participants received dabrafenib 150 mg gelatin capsules BID.
906546|NCT01072175|E5|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 2 mg|Melanoma BRAF-positive participants who received prior treatment with BRAF inhibitors and participants who had colorectal cancer and BRAFi naïve melanoma received dabrafenib 150 mg gelatin capsules BID and trametinib 2 mg tablets QD as continuous daily dosing. Dose escalation did not proceed beyond these doses of dabrafenib and trametinib.
906604|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906605|NCT01072136|O2|Outcome|Placebo|Placebo
917315|NCT01037218|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
906547|NCT01072175|E4|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1.5 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 150 mg gelatin capsules BID and trametinib 1.5 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906548|NCT01072175|E3|Reported Event|Part B: Dabrafenib 150 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors and participants who had salivary ductal cancer received dabrafenib 150 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available PK, safety, and other data from the first 4 evaluable participants and additional participants were enrolled based on DLTs occurring during the first 3 weeks of treatment.
906614|NCT01072032|P2|Participant Flow|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
917363|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
906549|NCT01072175|E2|Reported Event|Part B: Dabrafenib 75 mg + Trametinib 1 mg|Melanoma BRAF-positive participants who did not receive prior treatment with BRAF inhibitors received dabrafenib 75 mg gelatin capsules BID and trametinib 1 mg tablets QD as continuous daily dosing. Dose escalation decisions were made based on all available pharmacokinetic (PK), safety, and other data from the first 4 evaluable participants, and additional participants were enrolled based on dose-limiting toxicities (DLTs) occurring during the first 3 weeks of treatment.
906550|NCT01072175|E1|Reported Event|Part A: Dabrafenib 75 mg + Trametinib 2 mg|Participants received a single dose of dabrafenib 75 mg gelatin capsules with repeat dose trametinib (Day 15).
906551|NCT01072149|B1|Baseline|Entire Study Population|All participants who self-administered placebo, FF/VI 50/25 µg, FF/VI 100/25 µg, or FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI in any of the three 28-day treatment periods.
906552|NCT01072149|P18|Participant Flow|Sequence 18: FF/VI 100/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906553|NCT01072149|P17|Participant Flow|Sequence 17: FF/VI 50/25 µg, Placebo, FF/VI 200/25 µg|Participants self-administered FF/VI 50/25 µg, placebo, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906554|NCT01072149|P16|Participant Flow|Sequence 16: Placebo, FF/VI 50/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906555|NCT01072149|P15|Participant Flow|Sequence 15: FF/VI 100/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906556|NCT01072149|P14|Participant Flow|Sequence 14: FF/VI 200/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906557|NCT01072149|P13|Participant Flow|Sequence 13: Placebo, FF/VI 100/25 µg, FF/VI 200/25 µg|Participants self-administered placebo, FF/VI 100/25 µg, and FF/VI 200/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906558|NCT01072149|P12|Participant Flow|Sequence 12: Placebo, FF/VI 200/25 µg, FF/VI 50/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906559|NCT01072149|P11|Participant Flow|Sequence 11: Placebo, FF/VI 200/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 200/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906560|NCT01072149|P10|Participant Flow|Sequence 10: FF/VI 100/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 100/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906561|NCT01072149|P9|Participant Flow|Sequence 9: FF/VI 100/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 100/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906562|NCT01072149|P8|Participant Flow|Sequence 8: Placebo, FF/VI 50/25 µg, FF/VI 100/25 µg|Participants self-administered placebo, FF/VI 50/25 µg, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906563|NCT01072149|P7|Participant Flow|Sequence 7: FF/VI 200/25 µg, Placebo, FF/VI 50/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 50/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906564|NCT01072149|P6|Participant Flow|Sequence 6: FF/VI 50/25 µg, FF/VI 200/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 200/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906565|NCT01072149|P5|Participant Flow|Sequence 5: FF/VI 50/25 µg, FF/VI 100/25 µg, Placebo|Participants self-administered FF/VI 50/25 µg, FF/VI 100/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906606|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906607|NCT01072136|O2|Outcome|Placebo|Placebo
906566|NCT01072149|P4|Participant Flow|Sequence 4: FF/VI 200/25 µg, Placebo, and FF/VI 100/25 µg|Participants self-administered FF/VI 200/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906567|NCT01072149|P3|Participant Flow|Sequence 3: FF/VI 200/25 µg, FF/VI 50/25 µg, Placebo|Participants self-administered FF/VI 200/25 µg, FF/VI 50/25 µg, and placebo once every day (one inhalation in the morning) for 28 days via an IPI during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906615|NCT01072032|P1|Participant Flow|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
906569|NCT01072149|P1|Participant Flow|Sequence 1: FF/VI 50/25 µg, Placebo, FF/VI 100/25 µg|Participants self-administered fluticasone furoate/vilanterol (FF/VI) 50/25 µg, placebo, and FF/VI 100/25 µg once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during Treatment Periods 1, 2, and 3, respectively. The three treatment periods were separated by a 14-day washout period.
906570|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906571|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906572|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906573|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
906574|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906575|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906576|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906577|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
906578|NCT01072149|O4|Outcome|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906579|NCT01072149|O3|Outcome|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906580|NCT01072149|O2|Outcome|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906581|NCT01072149|O1|Outcome|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
906582|NCT01072149|E4|Reported Event|FF/VI 200/25 µg|Participants self-administered FF 200 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906583|NCT01072149|E3|Reported Event|FF/VI 100/25 µg|Participants self-administered FF 100 µg and VI 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906584|NCT01072149|E2|Reported Event|FF/VI 50/25 µg|Participants self-administered Fluticasone Furoate (FF) 50 micrograms (µg) and Vilanterol (VI) 25 µg as a dry powder once every day (one inhalation in the morning) for 28 days via an IPI during one of the three 28-day treatment periods.
906585|NCT01072149|E1|Reported Event|Placebo|Participants self-administered placebo once every day (one inhalation in the morning) for 28 days via an Investigational Product Inhaler (IPI) during one of the three 28-day treatment periods.
906586|NCT01072136|B3|Baseline|Total|Total of all reporting groups
906587|NCT01072136|B2|Baseline|Placebo|Placebo
906588|NCT01072136|B1|Baseline|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906589|NCT01072136|P2|Participant Flow|Placebo|Placebo
906590|NCT01072136|P1|Participant Flow|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906591|NCT01072136|O2|Outcome|Placebo|Placebo
906592|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906593|NCT01072136|O2|Outcome|Placebo|Placebo
906594|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906595|NCT01072136|O2|Outcome|Placebo|Placebo
906596|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906597|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
906598|NCT01072136|O2|Outcome|Partial Response|Partial response for mucopurulent cervicitis
906599|NCT01072136|O1|Outcome|Clinical Failure|Clinical failure for mucopurulent cervicitis
906600|NCT01072136|O3|Outcome|Clinical Cure|Clinical Cure for mucopurulent cervicitis
906608|NCT01072136|O1|Outcome|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906609|NCT01072136|E2|Reported Event|Placebo|Placebo
906610|NCT01072136|E1|Reported Event|Azithromycin/Cefixime|A single dose of cefixime 400 mg (1 tablet oral at 400 mg) and azithromycin 1 gram (2 tablets oral at 500 mg each)
906611|NCT01072032|B3|Baseline|Total|Total of all reporting groups
906612|NCT01072032|B2|Baseline|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
906613|NCT01072032|B1|Baseline|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
906616|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
906617|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
906618|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
906619|NCT01072032|O1|Outcome|Low-Reward|Low-Reward Anklebot training Group: The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team.
906620|NCT01072032|O2|Outcome|High-Reward|High-Reward Anklebot training Group: The high-reward group receives cumulative scores and abundant social interaction and are eligible for prizes during each training session and at completion of the study.
906621|NCT01072032|O1|Outcome|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): The low reward-feedback group receives the Anklebot training with only immediate feedback on target successes, without cumulative scores and with minimal social interaction with the research team."
906622|NCT01072032|E2|Reported Event|High-Reward|"High-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
906623|NCT01072032|E1|Reported Event|Low-Reward|"Low-Reward Anklebot training Group~Anklebot (Ankle Robot): Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery"
906624|NCT01072006|B5|Baseline|Total|Total of all reporting groups
906625|NCT01072006|B4|Baseline|TBI+PTSD Group|Combined TBI history and PTSD
906626|NCT01072006|B3|Baseline|TBI Group|TBI (no PTSD)
906627|NCT01072006|B2|Baseline|PTSD Group|PTSD (not TBI)
906628|NCT01072006|B1|Baseline|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
906629|NCT01072006|P4|Participant Flow|TBI+PTSD Group|Combined TBI history and PTSD
906630|NCT01072006|P3|Participant Flow|TBI Group|TBI (no PTSD)
906631|NCT01072006|P2|Participant Flow|PTSD Group|PTSD (not TBI)
906632|NCT01072006|P1|Participant Flow|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
906633|NCT01072006|O4|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
906634|NCT01072006|O3|Outcome|TBI Group|TBI (no PTSD)
906635|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
906636|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
906637|NCT01072006|O4|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
906638|NCT01072006|O3|Outcome|TBI Group|TBI (no PTSD)
906639|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
906640|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
906641|NCT01072006|O3|Outcome|TBI+PTSD Group|Combined TBI history and PTSD
906642|NCT01072006|O2|Outcome|PTSD Group|PTSD (not TBI)
906643|NCT01072006|O1|Outcome|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
906644|NCT01072006|E4|Reported Event|TBI+PTSD Group|Combined TBI history and PTSD
906645|NCT01072006|E3|Reported Event|TBI Group|TBI (no PTSD)
906646|NCT01072006|E2|Reported Event|PTSD Group|PTSD (not TBI)
906647|NCT01072006|E1|Reported Event|Control Group|Control group without traumatic brain injury (TBI) or post-traumatic stress disorder (PTSD)
906648|NCT01071915|B1|Baseline|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906649|NCT01071915|P1|Participant Flow|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906722|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
917316|NCT01037218|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
906650|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906651|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906652|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906653|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906734|NCT01071252|E4|Reported Event|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906654|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906655|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906656|NCT01071915|O1|Outcome|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906657|NCT01071915|E1|Reported Event|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenace of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
906658|NCT01071798|B1|Baseline|Main Analysis Set|Participants who received at least one cycle of rituximab
906659|NCT01071798|P1|Participant Flow|Main Analysis Set|Participants who received at least one cycle of rituximab
906660|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
906661|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
906662|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
906663|NCT01071798|O3|Outcome|Worse|Clinically relevant worsening of HAQ Score ≥0.3
906664|NCT01071798|O2|Outcome|No Change|Other or no clinical relevant change of HAQ-Score
906665|NCT01071798|O1|Outcome|Improved|Clinically relevant improvement of HAQ-Score ≥0.3
906666|NCT01071798|O3|Outcome|Total|During the Trial - All Participants
906667|NCT01071798|O2|Outcome|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
906668|NCT01071798|O1|Outcome|Cycle 1|During Cycle 1 - Main Analysis Set
906669|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
906670|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
906671|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
906672|NCT01071798|O3|Outcome|Seropositive Participants|Subgroup of seropositive participants
906673|NCT01071798|O2|Outcome|Seronegative Participants|Subgroup of seronegative participants
906674|NCT01071798|O1|Outcome|Main Analysis Set|Participants who received at least one cycle of rituximab
906675|NCT01071798|E3|Reported Event|Total|During the entire trial
906676|NCT01071798|E2|Reported Event|Cycle 2|During Cycle 2 - Subpopulation With Two Cycles
906677|NCT01071798|E1|Reported Event|Cycle 1|During Cycle 1 - Main Analysis Set
906678|NCT01071538|B1|Baseline|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906679|NCT01071538|P1|Participant Flow|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906680|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906681|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906682|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906723|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906683|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906684|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906685|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906735|NCT01071252|E3|Reported Event|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906736|NCT01071252|E2|Reported Event|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906686|NCT01071538|O1|Outcome|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906687|NCT01071538|E1|Reported Event|Buprenorphine|"Older adults with treatment resistant depression will receive buprenorphine up to 1.6 mg/day for 8 weeks. Discontinuation of the buprenorphine will occur during weeks 9-12.~Buprenorphine: Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day."
906688|NCT01071395|B3|Baseline|Total|Total of all reporting groups
906689|NCT01071395|B2|Baseline|Placebo|Placebo: Sugar pill given 3 times daily
906690|NCT01071395|B1|Baseline|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
906691|NCT01071395|P2|Participant Flow|Placebo|Placebo: Sugar pill given 3 times daily
906692|NCT01071395|P1|Participant Flow|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
906693|NCT01071395|O2|Outcome|Placebo|Placebo: Sugar pill given daily in three divided doses
906694|NCT01071395|O1|Outcome|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
906695|NCT01071395|E2|Reported Event|Placebo|Placebo: Sugar pill given 3 times daily
906696|NCT01071395|E1|Reported Event|Amantadine|Amantadine: Amantadine hydrochloride 300mg daily in three divided doses
906697|NCT01071278|B1|Baseline|Intent-to-Treat Population|Baseline characteristics were reported for the 2359 participants in the Intent-to-Treat (ITT) Population, which included all participants from the Evaluable Population who began therapy at or after Visit 1. The ITT Population excluded 31 of the 2390 evaluable participants who began treatment prior to Visit 1.
906698|NCT01071278|P1|Participant Flow|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
906699|NCT01071278|O1|Outcome|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
906700|NCT01071278|O2|Outcome|Patients Treated Outside a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and did not participate in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
906701|NCT01071278|O1|Outcome|Patients Treated Within a Disease Management Program|Participant prescribed Tredaptive® for dyslipidemia and also participated in a disease management program for treatment of diabetes mellitus, coronary heart disease or both.
906702|NCT01071278|E1|Reported Event|All Evaluable Participants|Participants who were prescribed Tredaptive® for the treatment of dyslipidemia and primary hypercholesterolemia as per the Summary of Product Characteristics (SmPC) by his/her primary physician in a routine clinical setting either within or outside a Disease Management Program (DMP).
906703|NCT01071252|B6|Baseline|Total|Total of all reporting groups
906704|NCT01071252|B5|Baseline|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906705|NCT01071252|B4|Baseline|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906706|NCT01071252|B3|Baseline|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906707|NCT01071252|B2|Baseline|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906708|NCT01071252|B1|Baseline|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
906709|NCT01071252|P5|Participant Flow|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906710|NCT01071252|P4|Participant Flow|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906711|NCT01071252|P3|Participant Flow|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906712|NCT01071252|P2|Participant Flow|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906713|NCT01071252|P1|Participant Flow|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
906714|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906715|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906716|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906717|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
906718|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906719|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906720|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906721|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906724|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906725|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906726|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906727|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
906728|NCT01071252|O5|Outcome|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906729|NCT01071252|O4|Outcome|AIN457 3x150mg|AIN457 150mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906730|NCT01071252|O3|Outcome|AIN457 3x75mg|AIN457 75mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906731|NCT01071252|O2|Outcome|AIN457 3x25mg|AIN457 25mg subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906732|NCT01071252|O1|Outcome|AIN457 1x25mg|AIN457 25mg Subcutaneously as a single dose
906733|NCT01071252|E5|Reported Event|Placebo|Placebo subcutaneous monthly dosing, 3 times (weeks 1, 5, and 9)
906740|NCT01071200|B1|Baseline|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906741|NCT01071200|P2|Participant Flow|Follicle-stimulating Hormone (FSH)|FSH injection s.c. administered according to investigator’s discretion till r-hCG administration day.
906742|NCT01071200|P1|Participant Flow|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906743|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906744|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906745|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906746|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906747|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906748|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906749|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906750|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906751|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906752|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906753|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906754|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906755|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906756|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906757|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906758|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906759|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906760|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906761|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906762|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906881|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906764|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906765|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906766|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906767|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906768|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906769|NCT01071200|O2|Outcome|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906770|NCT01071200|O1|Outcome|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906771|NCT01071200|E2|Reported Event|Follicle-stimulating Hormone (FSH)|FSH injection administered according to investigator's discretion till r-hCG administration day.
906772|NCT01071200|E1|Reported Event|FSH + rhLH|Follicle-stimulating hormone (FSH) injection administered according to investigator's discretion till Day 8 of stimulation period (S8) and treatment with recombinant human luteinizing hormone (rhLH, Luveris) injection 150 International Units (IU) subcutaneously (s.c.) daily was started from S8 until recombinant human choriogonadotropin (r-hCG) administration day. r-hLH was administered in a 2:1 ratio (FSH:r-hLH).
906773|NCT01071096|B1|Baseline|Enrolled Participants|Enrolled Participants includes subjects in both Group A (treated with BOTOX and Visit 1 and Placebo at Visit 5) and Group B (treated with Placebo at Visit 1 and BOTOX at Visit 5).
906774|NCT01071096|P2|Participant Flow|Group B|Subjects were injected with Saline at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with OnabotulinumtoxinA at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
906775|NCT01071096|P1|Participant Flow|Group A|Subjects were injected with OnabotulinumtoxinA at Visit 1 (Day 1) and followed for 3 months through monthly office visits (Visits 2, 3, and 4 at Days 31, 61 and 91). Subjects went through a 1 month (30 day) washout period between Visit 4 (Day 91) and Visit 5 (Day 121). Subjects were injected with Saline at Visit 5 (Day 121) and followed for 3 months through monthly office visits (Visits 5, 6, and 7 at Days 151, 181, and 211).
906776|NCT01071096|O6|Outcome|Month 1 vs. Month 3 Non-Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with <30% reduction in number of headache days per month from baseline.
906777|NCT01071096|O5|Outcome|Month 1 vs. Month 3 Responders|Fold change between first and third treatment months with OnabotulinumtoxinA in subjects with >30% reduction in number of headache days per month from baseline.
906778|NCT01071096|O4|Outcome|Month 3 vs. Saline Non-Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
906779|NCT01071096|O3|Outcome|Month 3 vs. Saline Responders|Fold change between third treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
906780|NCT01071096|O2|Outcome|Month 1 vs. Saline Non-Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with <30% reduction in number of headache days per month from baseline.
906864|NCT01071044|E1|Reported Event|Treatment Group|Lisdexamfetamine Dimesylate 30, 50, or 70 mg
906781|NCT01071096|O1|Outcome|Month 1 vs. Saline Responders|Fold change between first treatment months with OnabotulinumtoxinA and Saline in subjects with >30% reduction in number of headache days per month from baseline.
906782|NCT01071096|O3|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
906783|NCT01071096|O2|Outcome|OnabotulinumtoxinA Non-Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with <30% reduction in number of headache days per month when compared to Baseline
906784|NCT01071096|O1|Outcome|OnabotulinumtoxinA Responders|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7). Includes subjects with >30% reduction in number of headache days per month when compared to Baseline
906785|NCT01071096|O2|Outcome|Saline|This group is a combination of information gathered from both groups while treating with Saline: Group A (Months 5-7) and Group B (Months 1-3).
906786|NCT01071096|O1|Outcome|OnabotulinumtoxinA|This group is a combination of information gathered from both groups while treating with OnabotulinumtoxinA: Group A (Months 1-3) and Group B (Months 5-7).
906787|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
906788|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
906882|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
906789|NCT01071096|O2|Outcome|Group B|Saline at Visit 1 (headache days in Months 1, 2 and 3) and OnabotulinumtoxinA at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
906790|NCT01071096|O1|Outcome|Group A|OnabotulinumtoxinA at Visit 1 (headache days in Months 1, 2 and 3) and Saline at Visit 5 (headache days in Months 5, 6 and 7) with washout and crossover at Month 4
906791|NCT01071096|E2|Reported Event|OnabotulinumtoxinA|Subjects injected with onabotulinumtoxinA in Group A at Visit 1 (Day 1) and Group B at Visit 5 (Day 151)
906792|NCT01071096|E1|Reported Event|Saline|Subjects injected with Saline in Group A at Visit 5 (Day 151) and Group B at Visit 1 (Day 1)
906793|NCT01071083|B6|Baseline|Total|Total of all reporting groups
906794|NCT01071083|B5|Baseline|Methylprednisolone|1000 mg intravenous every 4 weeks
906795|NCT01071083|B4|Baseline|Glatiramer Acetate|20 mg subcutaneous once daily
906796|NCT01071083|B3|Baseline|Interferon β-1a|30 ug intramuscular once per week
906797|NCT01071083|B2|Baseline|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
906798|NCT01071083|B1|Baseline|Natalizumab|300 mg intravenous every 4 weeks
906799|NCT01071083|P5|Participant Flow|Methylprednisolone|1000 mg intravenous every 4 weeks
906800|NCT01071083|P4|Participant Flow|Glatiramer Acetate|20 mg subcutaneous once daily
906801|NCT01071083|P3|Participant Flow|Interferon β-1a|30 ug intramuscular once per week
906802|NCT01071083|P2|Participant Flow|Natalizumab|300 mg intravenous every 4 weeks
906803|NCT01071083|P1|Participant Flow|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
906804|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
906805|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
906806|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
906807|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
906808|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
906809|NCT01071083|O5|Outcome|Methylprednisolone|1000 mg intravenous every 4 weeks
906810|NCT01071083|O4|Outcome|Glatiramer Acetate|20 mg subcutaneous once daily
906811|NCT01071083|O3|Outcome|Interferon β-1a|30 ug intramuscular once per week
906812|NCT01071083|O2|Outcome|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
906813|NCT01071083|O1|Outcome|Natalizumab|300 mg intravenous every 4 weeks
906814|NCT01071083|E5|Reported Event|Methylprednisolone|1000 mg intravenous every 4 weeks
906815|NCT01071083|E4|Reported Event|Glatiramer Acetate|20 mg subcutaneous once daily
906816|NCT01071083|E3|Reported Event|Interferon β-1a|30 ug intramuscular once per week
906817|NCT01071083|E2|Reported Event|Natalizumab|300 mg intravenous every 4 weeks
906818|NCT01071083|E1|Reported Event|Intravenous Placebo|placebo matching natalizumab, intravenous every 4 weeks
906819|NCT01071070|B3|Baseline|Total|Total of all reporting groups
906820|NCT01071070|B2|Baseline|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906821|NCT01071070|B1|Baseline|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906822|NCT01071070|P2|Participant Flow|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906823|NCT01071070|P1|Participant Flow|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906824|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906825|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906826|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906827|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906828|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906829|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906865|NCT01070979|B4|Baseline|Total|Total of all reporting groups
906830|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906831|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906832|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906833|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906834|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906835|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906836|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906837|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906838|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906839|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906883|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906840|NCT01071070|O2|Outcome|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906841|NCT01071070|O1|Outcome|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906842|NCT01071070|E2|Reported Event|Group 2|Dose determined by US paricalcitol injection package insert dosing instructions (starting dose at 0.04 microgram/kg)
906843|NCT01071070|E1|Reported Event|Group 1|Initial dosing based on a formula of intact parathyroid hormone value/80 (where intact parathyroid hormone value is the baseline value in pg/mL).
906844|NCT01071044|B3|Baseline|Total|Total of all reporting groups
906845|NCT01071044|B2|Baseline|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
906846|NCT01071044|B1|Baseline|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
906847|NCT01071044|P2|Participant Flow|Sugar Pill|Placebo Comparator: Sugar pill : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
906848|NCT01071044|P1|Participant Flow|Lisdexamfetamine Dimesylate|"Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.~Lisdexamfetamine Dimesylate : Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo)."
906849|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
906850|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
906851|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
906852|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate, 30, 50 or 70 mg
906853|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
906854|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
906855|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50, or 70mg"
906856|NCT01071044|O1|Outcome|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate 30, 50, 70 mg
906857|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
906858|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
906859|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
906860|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
906861|NCT01071044|O2|Outcome|Control Group|"Placebo 30, 50 or 70 mg"
906862|NCT01071044|O1|Outcome|Treatment Group|Lisdexamfetamine Dimesylate 30, 50 or 70 mg
906863|NCT01071044|E2|Reported Event|Control Group|"Placebo 30, 50 or 70 mg"
917317|NCT01037218|P4|Participant Flow|Placebo|Placebo tablets
906866|NCT01070979|B3|Baseline|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906867|NCT01070979|B2|Baseline|Estradiol|1 tablet daily containing 1 mg estradiol
906868|NCT01070979|B1|Baseline|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906869|NCT01070979|P3|Participant Flow|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906870|NCT01070979|P2|Participant Flow|Estradiol|1 tablet daily containing 1 mg estradiol
906871|NCT01070979|P1|Participant Flow|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906872|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906873|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
906874|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906875|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906876|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
906877|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906878|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906879|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
906880|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906887|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906888|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
906889|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906890|NCT01070979|O3|Outcome|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906891|NCT01070979|O2|Outcome|Estradiol|1 tablet daily containing 1 mg estradiol
906892|NCT01070979|O1|Outcome|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906893|NCT01070979|E3|Reported Event|Conjugated Equine Estrogens (CEE)|1 tablet daily containing 0.625 mg conjugated equine estrogen
906894|NCT01070979|E2|Reported Event|Estradiol|1 tablet daily containing 1 mg estradiol
906895|NCT01070979|E1|Reported Event|Estradiol Acetate (E3A)|1 tablet daily containing 0.9 mg estradiol acetate
906896|NCT01070966|B1|Baseline|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH) treated with VYTORIN® ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
906897|NCT01070966|P1|Participant Flow|VYTORIN® 10/10 mg/Day to 10/80 mg/Day|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia (HoFH)treated with VYTORIN® dosages ranging from 10/10(ezetimibe 10 mg/simvastatin 10 mg tablets)a day to 10/80(ezetimibe 10 mg/simvastatin 80 mg tablets)a day.
906898|NCT01070966|O3|Outcome|Participants Percent Change|
906899|NCT01070966|O2|Outcome|Participants Treatment Lipid Parameters|Participants treatment lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
906900|NCT01070966|O1|Outcome|Participants Baseline Lipid Parameters|Participants baseline lipid parameters for Total Cholesterol, HDL cholesterol, LDL cholesterol and Triglyceride.
906901|NCT01070966|O1|Outcome|Participants Treated With VYTORIN|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Years 1 to 6.
906902|NCT01070966|E5|Reported Event|VYTORIN YEAR 6|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 6
906903|NCT01070966|E4|Reported Event|VYTORIN YEAR 5|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 5
906904|NCT01070966|E3|Reported Event|VYTORIN YEAR 4|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 4
906905|NCT01070966|E2|Reported Event|VYTORIN YEAR 2|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 2
906906|NCT01070966|E1|Reported Event|VYTORIN YEAR 1|Participants with atherosclerosis treated with Vytorin ranging from 10/10 mg/day through 10/80 mg/day for Year 1
906907|NCT01070953|B1|Baseline|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
906908|NCT01070953|P1|Participant Flow|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
906909|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
906910|NCT01070953|O1|Outcome|All Participants|
906911|NCT01070953|O1|Outcome|EZETROL® 10 mg|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily.
906912|NCT01070953|E6|Reported Event|EZETROL Year 6|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 6.
906913|NCT01070953|E5|Reported Event|EZETROL Year 5|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 5.
906914|NCT01070953|E4|Reported Event|EZETROL Year 4|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 4.
906957|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906915|NCT01070953|E3|Reported Event|EZETROL Year 3|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 3.
906916|NCT01070953|E2|Reported Event|EZETROL Year 2|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 2.
906917|NCT01070953|E1|Reported Event|EZETROL Year 1|Participants with Hypercholesterolemia and Homozygous Familial Hypercholesterolemia(HoFH) treated with EZETROL® 10 mg once daily in Year 1.
906918|NCT01070888|B3|Baseline|Total|Total of all reporting groups
906919|NCT01070888|B2|Baseline|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks,"
906920|NCT01070888|B1|Baseline|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide first: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
906921|NCT01070888|P2|Participant Flow|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide and dummy inhale, 2 inhalations of each, twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
906922|NCT01070888|P1|Participant Flow|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Subjects will subsequently take blinded budesonide/formoterol and dummy inhale, 2 inhalations of each, twice daily.~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
906923|NCT01070888|O2|Outcome|Budesonide/Formoterol First|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily, then in the subsequent period take budesonide and dummy inhaler 2 puffs twice daily.~Budesonide/Formoterol : Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks"
906924|NCT01070888|O1|Outcome|Budesonide First|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily. Then in the subsequent study period take budesonide/formoterol plus dummy inhaler 2 inhalations of each inhaler, twice daily~Budesonide : Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
906925|NCT01070888|E2|Reported Event|Budesonide|"This arm will receive blinded budesonide and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide: Budesonide 180mcg, 2 puffs twice daily for 2 weeks, followed by a washout, then Budesonide/formoterol 180mcg, 2 puffs twice daily for 2 weeks"
906926|NCT01070888|E1|Reported Event|Budesonide/Formoterol|"This arm will receive blinded budesonide/formoterol and dummy inhaler and will be asked to take 2 inhalations of each inhaler, twice daily.~Budesonide/Formoterol: Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks, followed by a washout, then Budesonide 180mcg, 2 puffs twice daily for 2 weeks"
906927|NCT01070810|B3|Baseline|Total|Total of all reporting groups
906928|NCT01070810|B2|Baseline|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
906929|NCT01070810|B1|Baseline|Placebo|50 ml D5W D5W: Dextrose 5%
906930|NCT01070810|P2|Participant Flow|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
906931|NCT01070810|P1|Participant Flow|Placebo|"50 ml D5W~D5W: Dextrose 5%"
906932|NCT01070810|O2|Outcome|Thiamine Deficient, Received Placebo|Thiamine deficient (≤ 7 nmol/L) received 50ml D5W
906933|NCT01070810|O1|Outcome|Thiamine Deficient Received Thiamine|Thiamine deficient (≤ 7 nmol/L) received 200mg Thiamine in 50ml D5W
906934|NCT01070810|O2|Outcome|Thiamine Deficient, Received Placebo|Thiamine deficient (≤ 7 nmol/L) received 50ml D5W
906935|NCT01070810|O1|Outcome|Thiamine Deficient Received Thiamine|Thiamine deficient (≤ 7 nmol/L) received 200mg Thiamine in 50ml D5W
906936|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
906937|NCT01070810|O1|Outcome|Placebo|"50 ml D5W~D5W: Dextrose 5%"
906938|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
906939|NCT01070810|O1|Outcome|Placebo|"50 ml D5W~D5W: Dextrose 5%"
906940|NCT01070810|O2|Outcome|Thiamine|"200mg Thiamine in 50ml D5W~Thiamine: Thiamine 200mg in 50ml Dextrose 5%"
906941|NCT01070810|O1|Outcome|Placebo|"50 ml D5W~D5W: Dextrose 5%"
906942|NCT01070810|E2|Reported Event|Thiamine|200mg Thiamine in 50ml D5W Thiamine: Thiamine 200mg in 50ml Dextrose 5%
906943|NCT01070810|E1|Reported Event|Placebo|50 ml D5W D5W: Dextrose 5%
906944|NCT01070784|B3|Baseline|Total|Total of all reporting groups
906945|NCT01070784|B2|Baseline|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906946|NCT01070784|B1|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906947|NCT01070784|P2|Participant Flow|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906948|NCT01070784|P1|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906949|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906950|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906951|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906952|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906953|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906954|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906955|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906956|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907239|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
906958|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906959|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906960|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906961|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906962|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906963|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906964|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906965|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906966|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906967|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906968|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906969|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906970|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906971|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906972|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906973|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906974|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907370|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
906975|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906976|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906977|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906978|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906979|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906980|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906981|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906982|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906983|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906984|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906985|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906986|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906987|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906988|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906989|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906990|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906991|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906992|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906993|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906994|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906995|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906996|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906997|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
906998|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
906999|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907000|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907001|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907002|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907003|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907004|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907005|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907006|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907007|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907008|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907009|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907010|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907011|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907012|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907013|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907014|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907015|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907016|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907017|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907018|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907019|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907020|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907021|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907022|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907023|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907024|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907025|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907026|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907027|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907028|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907029|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907030|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907031|NCT01070784|O2|Outcome|Arm 2 - COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907032|NCT01070784|O1|Outcome|Arm 1 - Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907033|NCT01070784|E2|Reported Event|COPD Standard Therapy|Standard COPD treatment according to JRS guideline and GOLD guideline
907034|NCT01070784|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler, 160/4.5 microgram(mcg), 2 inhalations twice daily
907035|NCT01070771|B1|Baseline|Radi Pressure Wire|
907036|NCT01070771|P1|Participant Flow|Radi Pressure Wire|Assessment of physiological significance of coronary artery narrowings by measurement of blood flow limitation across lesion.
907037|NCT01070771|O1|Outcome|RADI Pressure Wire|
907038|NCT01070771|O1|Outcome|Radi Pressure Wire|
907039|NCT01070771|E1|Reported Event|RADI Pressure Wire|
907040|NCT01070693|B3|Baseline|Total|Total of all reporting groups
907041|NCT01070693|B2|Baseline|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
907042|NCT01070693|B1|Baseline|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
907043|NCT01070693|P2|Participant Flow|Lichtenstein|Inguinal hernia repair with the Lichtenstein technique
907044|NCT01070693|P1|Participant Flow|Prolene Hernia System Device|Inguinal hernia repair either with a bilayer mesh (PHS)
907045|NCT01070693|O2|Outcome|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
907046|NCT01070693|O1|Outcome|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
907047|NCT01070693|E2|Reported Event|Lichtenstein|"Inguinal hernia repair with the Lichtenstein technique~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Lichtenstein technique: Lichtenstein technique"
907048|NCT01070693|E1|Reported Event|Prolene Hernia System Device|"Inguinal hernia repair either with a bilayer mesh (PHS)~Open mesh inguinal hernia repair: Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique~Prolene Hernia System: Prolene Hernia System"
907049|NCT01070550|B7|Baseline|Total|Total of all reporting groups
907050|NCT01070550|B6|Baseline|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907051|NCT01070550|B5|Baseline|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907052|NCT01070550|B4|Baseline|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907053|NCT01070550|B3|Baseline|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907054|NCT01070550|B2|Baseline|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907055|NCT01070550|B1|Baseline|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907056|NCT01070550|P6|Participant Flow|Genotype Unknown|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907057|NCT01070550|P5|Participant Flow|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907058|NCT01070550|P4|Participant Flow|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
907059|NCT01070550|P3|Participant Flow|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received peginterferon alfa-2a plus ribavirin according to the standard of care and in line with SPCs/local labeling were observed for up to 72 weeks.
907060|NCT01070550|P2|Participant Flow|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labelling were observed for up to 72 weeks.
907061|NCT01070550|P1|Participant Flow|Genotype 1|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received PEGASYS® (Pegylated Interferon [PEG-IFN]) alfa-2a plus ribavirin according to the standard of care and in line with summary of product characteristics (SPCs)/local labelling were observed for up to 72 weeks.
907062|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907063|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907371|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
907372|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
907064|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907065|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907066|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907067|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907068|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907069|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907070|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907071|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907072|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907073|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907074|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907075|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907076|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907077|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907078|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907079|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907080|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907081|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907082|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907083|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907084|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907085|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907086|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907087|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907088|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907089|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907090|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907091|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907373|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
907092|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907093|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907094|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907095|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907096|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907097|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907098|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907099|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907100|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907101|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907102|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907103|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907104|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907105|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907106|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907107|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907108|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907109|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907110|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907111|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908184|NCT01068158|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
907112|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907113|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907114|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907115|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907116|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907117|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907118|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907119|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907120|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907121|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907122|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907123|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907124|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907125|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907126|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907127|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907128|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907129|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907130|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907131|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907132|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907133|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907134|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907135|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907136|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907137|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907138|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907139|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908251|NCT01067976|O1|Outcome|CMRM|
908252|NCT01067976|O2|Outcome|CMRM|
907140|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907141|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907142|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907143|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907144|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907145|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907146|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907147|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907148|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907149|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907150|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907151|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907152|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907153|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907154|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907155|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907156|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907157|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907158|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907159|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907160|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907161|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907162|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907163|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907164|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907165|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907166|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907167|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908253|NCT01067976|O1|Outcome|UMRM|
908254|NCT01067976|O1|Outcome|CMRM vs UMRM|
907168|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907169|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907170|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907171|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907172|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907173|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907174|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907175|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907176|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907177|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907178|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907179|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907180|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907181|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907182|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907183|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907184|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907185|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907186|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907187|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907188|NCT01070550|O6|Outcome|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907189|NCT01070550|O5|Outcome|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907190|NCT01070550|O4|Outcome|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907191|NCT01070550|O3|Outcome|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907192|NCT01070550|O2|Outcome|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907193|NCT01070550|O1|Outcome|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received Peginterferon (PEG-IFN) alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907194|NCT01070550|E6|Reported Event|Genotype Unknown|Eligible participants infected with HCV of Unknown Genotype who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907195|NCT01070550|E5|Reported Event|Genotype 5/6|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
909786|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
907196|NCT01070550|E4|Reported Event|Genotype 4|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907197|NCT01070550|E3|Reported Event|Genotype 3|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907198|NCT01070550|E2|Reported Event|Genotype 2|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907199|NCT01070550|E1|Reported Event|Genotype 1|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
907200|NCT01070394|B1|Baseline|LDX Treatment|Prospective participants will be evaluated for ADHD and study inclusion/exclusion criteria. Eligible participants will begin open-label lisdexamfetamine dimesylate for 12 weeks. Those who were able to complete all 12 weeks of the treatment were evaluated for data purposes.
907209|NCT01070394|O1|Outcome|Overall Study|"Eligible participants received 12 weeks of open-label treatment. Those on treatment prior to baseline underwent a 7-day (for amphetamine or methylphenidate) or 28-day (for atomoxetine or other medications) washout period prior to initiating LDX treatment. The starting dose was 30mg/day, which could be titrated up by 20mg/day during visits 2-6 (for a maximum dose of 70mg/day). At discretion of investigator, the dose could be down-titrated by 20mg/day during visits 4-6. Once the dose was optimized (after visit 6), the dose was maintained for 8 weeks.~LDX Treatment: 30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks."
907201|NCT01070394|P1|Participant Flow|Overall Study: Lisdexamfetamine Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907202|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907203|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907204|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907205|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907206|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907207|NCT01070394|O1|Outcome|Treatment Arm|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907208|NCT01070394|O1|Outcome|Overall Study|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907248|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907249|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907374|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
907375|NCT01069939|E2|Reported Event|Placebo|Placebo once daily oral
907210|NCT01070394|E1|Reported Event|LDX Treatment|The treatment arm will receive 12 weeks of Lisdexamfetamine Dimesylate-LDX treatment. At baseline, participants were initiated on LDX at a dose of 30 mg/day and began a 4-week dose optimization phase with weekly clinic visits. The dose optimization phase was followed by an 8-week dose maintenance phase, which included clinic visits every 2 weeks for the assessment of safety and efficacy. At visits 3-6, the dose of LDX was increased by 20 mg/day until an optimal dose or the maximum dose of 80 mg/day was reached. An optimal dose was determined by clinical efficacy, defined as a >= 30% reduction in the baseline ADHD Rating Scale, and tolerability. At the discretion of the investigator, the dose could be down-titrated by 20 mg/day at visits 4-6. When an optimal dose was reached, the participant remained at this level for the duration of the study.
907211|NCT01070381|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
907212|NCT01070381|P2|Participant Flow|Ocufilcon D / Nelfilcon A|Ocufilcon D contact lenses worn first, with nelfilcon A contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
907213|NCT01070381|P1|Participant Flow|Nelfilcon A / Ocufilcon D|Nelfilcon A contact lenses worn first, with ocufilcon D contact lenses worn second. Both products worn bilaterally on a daily wear, daily disposable basis for one week each.
907214|NCT01070381|O2|Outcome|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
907215|NCT01070381|O1|Outcome|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
907216|NCT01070381|E2|Reported Event|Ocufilcon D|Commercially marketed, toric, soft contact lens for daily disposable wear
907217|NCT01070381|E1|Reported Event|Nelfilcon A|Commercially marketed, toric, soft contact lens for daily disposable wear
907218|NCT01070329|B3|Baseline|Total|Total of all reporting groups
907219|NCT01070329|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
907220|NCT01070329|B1|Baseline|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907221|NCT01070329|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
907222|NCT01070329|P1|Participant Flow|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907223|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907224|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907225|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907226|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907227|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907228|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907229|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907230|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907231|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907232|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907233|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907234|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907235|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907236|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907237|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907238|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907240|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907241|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907242|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907243|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907244|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907245|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907246|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907247|NCT01070329|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
907250|NCT01070329|O1|Outcome|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907251|NCT01070329|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
907252|NCT01070329|E1|Reported Event|Duloxetine|Participants received 30 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
907253|NCT01070316|B1|Baseline|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
907254|NCT01070316|P1|Participant Flow|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
907255|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
907256|NCT01070316|O1|Outcome|Everolimus|"Main Study Phase:~Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day~Following the 4 week titration, subjects will continue in an 8 week maintenance period.~If subjects qualify for the Extension Phase of the study, they will continue on study drug and be followed through 48 months."
907257|NCT01070316|E1|Reported Event|Everolimus|"Subjects will be administered study drug if they meet study criteria after 4 weeks of baseline phase. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily.~Everolimus: Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day"
907258|NCT01070303|B3|Baseline|Total|Total of all reporting groups
907259|NCT01070303|B2|Baseline|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
919947|NCT01029886|B3|Baseline|Total|Total of all reporting groups
907260|NCT01070303|B1|Baseline|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907261|NCT01070303|P1|Participant Flow|All Participants in Open-Label Extension of Study M02-433|Participants who were still receiving study drug and were evaluated at Week 56 of NCT00055497 could continue into the OLE. In the OLE, participants who received double-blind study drug (adalimumab 40 mg) during the DB portion were started on adalimumab 40 mg every other week (eow). Participants who received OL adalimumab 40 mg during the DB portion continued the dose they were receiving. Any participant who was receiving 40 mg adalimumab eow during the OLE and who experienced a disease flare (recurrence of active disease) could change to 40 mg adalimumab weekly. 176 participants were documented as completing Year 1 of the study; however, efficacy data were recorded for 177 participants at Week 56, and those participants are included in the OLE. Safety data are summarized for all participants (N = 276) who entered the study (NCT00055497).
907262|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907263|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
917364|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
907264|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907265|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907266|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907267|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907268|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907269|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907270|NCT01070303|O4|Outcome|Change From Baseline-Week 248|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
907271|NCT01070303|O3|Outcome|Change From Baseline-Week 200|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
907272|NCT01070303|O2|Outcome|Change From Baseline-Week 152|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
907273|NCT01070303|O1|Outcome|Change From Baseline-Week 104|The last non-missing measure collected on or before the first dose of study drug in the lead-in study, NCT00055523, was used as Baseline to determine efficacy changes. Only participants who had Baseline and post Baseline visits were included in the analyses.
907274|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907275|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907276|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907277|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907278|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907279|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907280|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907281|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
909608|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
907282|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907283|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907284|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907285|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907286|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907287|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907288|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907289|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907290|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907291|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907292|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907293|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907294|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907295|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907296|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907297|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907298|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907299|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907300|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907301|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907302|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907303|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907304|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907305|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907345|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907306|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907307|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907308|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907309|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907310|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907311|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907312|NCT01070303|O2|Outcome|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907313|NCT01070303|O1|Outcome|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907314|NCT01070303|E2|Reported Event|Non-Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline non-remitters were subjects who did not demonstrate clinical remission at Week 0 of NCT00055497, or who were no longer in remission at Week 4 of NCT00055497.
907315|NCT01070303|E1|Reported Event|Remitters|Adalimumab 40 mg by subcutaneous injection every other week or every week. Baseline remitters were subjects who demonstrated clinical remission (CDAI score < 150 points) at Week 0 of NCT00055497 and remained in clinical remission at Week 4 of NCT00055497.
907316|NCT01070173|B4|Baseline|Total|Total of all reporting groups
907317|NCT01070173|B3|Baseline|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms
907318|NCT01070173|B2|Baseline|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive)
907319|NCT01070173|B1|Baseline|Short Stature|Poor linear growth
907320|NCT01070173|P3|Participant Flow|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
907321|NCT01070173|P2|Participant Flow|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
907322|NCT01070173|P1|Participant Flow|Short Stature|Poor linear growth Group
907323|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
907324|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
907325|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
907326|NCT01070173|O3|Outcome|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
907327|NCT01070173|O2|Outcome|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
907328|NCT01070173|O1|Outcome|Short Stature|Poor linear growth Group
907329|NCT01070173|E3|Reported Event|Isolated Gastrointestinal Symptoms|Isolated Gastrointestinal Symptoms Group
907330|NCT01070173|E2|Reported Event|Poor Weight Gain (Failure-To-Thrive)|Poor Weight Gain (Failure-To-Thrive) Group
907331|NCT01070173|E1|Reported Event|Short Stature|Poor linear growth Group
907332|NCT01070043|B3|Baseline|Total|Total of all reporting groups
907333|NCT01070043|B2|Baseline|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907334|NCT01070043|B1|Baseline|Amlodipine 5mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907335|NCT01070043|P3|Participant Flow|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907336|NCT01070043|P2|Participant Flow|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907337|NCT01070043|P1|Participant Flow|Run-In Valsartan 80 mg|During run-in period, oral valsartan 80 mg once daily for 4 weeks.
907338|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907339|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907340|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907341|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907342|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907343|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907344|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907346|NCT01070043|O2|Outcome|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907347|NCT01070043|O1|Outcome|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907348|NCT01070043|E2|Reported Event|Valsartan 160 mg|In double blinded treatment period, patients randomized to this arm received 160 mg Valsartan once daily for 8 weeks.
907349|NCT01070043|E1|Reported Event|Amlodipine 5 mg/Valsartan 80 mg|During double-blind treatment period, patients randomized to combination therapy received daily one dosage (Amlodipine/Valsartan 5mg/80mg) with one single tablet size for 8 weeks.
907350|NCT01069939|B3|Baseline|Total|Total of all reporting groups
907351|NCT01069939|B2|Baseline|Placebo|Placebo once daily oral
907352|NCT01069939|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
907353|NCT01069939|P2|Participant Flow|Placebo|Placebo once daily oral
907354|NCT01069939|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
907355|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
907356|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
907357|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
907358|NCT01069939|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
907359|NCT01069939|O2|Outcome|Placebo|Placebo once daily oral
907376|NCT01069939|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20mg once daily oral
907377|NCT01069900|B3|Baseline|Total|Total of all reporting groups
907378|NCT01069900|B2|Baseline|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907379|NCT01069900|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907380|NCT01069900|P2|Participant Flow|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907381|NCT01069900|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907382|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907383|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907384|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907385|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907386|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907387|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907429|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907388|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907389|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907390|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907391|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907392|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907393|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907394|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907395|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907488|NCT01069523|P2|Participant Flow|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907396|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907397|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907398|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907399|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907400|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907401|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907402|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907403|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907404|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907405|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907406|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907407|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907408|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907409|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907410|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907411|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907412|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907413|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907414|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907415|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907416|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907417|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907418|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907419|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907420|NCT01069900|O2|Outcome|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907421|NCT01069900|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % sodium chloride [NaCl solution]) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5- 14 days.
907422|NCT01069900|E2|Reported Event|Comparator Ertapenem|Subjects randomized to the comparator arm of this study received intravenous ertapenem plus moxifloxacin placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, amoxicillin/clavulanate as an oral suspension plus PO moxifloxacin placebo. Total treatment duration is 5-14 days.
907423|NCT01069900|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects randomized to the moxifloxacin arm of this study received intravenous moxifloxacin plus ertapenem placebo (0.9 % NaCl solution) for a minimum of 3 days and, if switched to oral treatment, PO moxifloxacin plus PO amoxicillin/clavulanate placebo. Total treatment duration is 5-14 days.
907424|NCT01069861|B1|Baseline|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907425|NCT01069861|P1|Participant Flow|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 milligram per kilogram (mg/kg) over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg per hour (mg/kg/hr) intravenous infusion up to 14 days, based on the need of individual participant.
907426|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907427|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907428|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
921567|NCT01026220|O1|Outcome|Group 1|All Patients
907430|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907431|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907432|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907433|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907434|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907435|NCT01069861|O1|Outcome|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907436|NCT01069861|E1|Reported Event|Sildenafil|Sildenafil citrate administered intravenously at a loading dose of 0.1 mg/kg over 30 minutes infusion followed by a maintenance dose of 0.03 mg/kg/hr intravenous infusion up to 14 days, based on the need of individual participant.
907437|NCT01069627|B1|Baseline|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907513|NCT01069419|E1|Reported Event|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
907438|NCT01069627|P1|Participant Flow|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 milligrams/kilogram (mg/kg) intravenously (IV) on Day 1 and fotemustine 100 mg per square meter (mg/m^2) IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907439|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907440|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907441|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907442|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907472|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907473|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907474|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907443|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907444|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907445|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907489|NCT01069523|P1|Participant Flow|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907490|NCT01069523|O2|Outcome|Guanfacine|Blinded guanfacine capsule
907446|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907447|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907448|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907449|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907450|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907451|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907475|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907452|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907453|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907454|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907455|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907456|NCT01069627|O1|Outcome|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907457|NCT01069627|E1|Reported Event|Bevacizumab + Fotemustine|"Cycle 1 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 and fotemustine 100 mg/m^2 IV on Days 1, 8, and 15 followed by 1 week off. Cycle 1 was not repeated.~Cycle 2 (3-week cycle): Participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. Cycle 2 was not repeated.~Cycles 3-8 (3-week cycles): Participants received bevacizumab 15 mg/kg IV and fotemustine 100 mg/m^2 IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks for 4 to 6 cycles.~Cycles 9 and beyond (3-week cycles): If the previous 6 to 8 cycles were tolerated with no disease progression, then participants received bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off. This cycle was repeated every 3 weeks until disease progression or unacceptable toxicity."
907458|NCT01069562|B3|Baseline|Total|Total of all reporting groups
907459|NCT01069562|B2|Baseline|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907460|NCT01069562|B1|Baseline|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907461|NCT01069562|P2|Participant Flow|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907462|NCT01069562|P1|Participant Flow|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907463|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907464|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907465|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907466|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907467|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907468|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907469|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907470|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907471|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
909609|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
907476|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907477|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907478|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907479|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907480|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907481|NCT01069562|O2|Outcome|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907482|NCT01069562|O1|Outcome|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907483|NCT01069562|E2|Reported Event|IAADS Group|In this group, liquid isoflurane will be injected into the circuit using a syringe pump controlled by the IAADS system.
907484|NCT01069562|E1|Reported Event|Manual|The manual group in which isoflurane will be administered using Tech 7 vapouriser. The dial setting will be controlled by the anesthesiologist.
907485|NCT01069523|B3|Baseline|Total|Total of all reporting groups
907486|NCT01069523|B2|Baseline|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907487|NCT01069523|B1|Baseline|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907491|NCT01069523|O1|Outcome|Placebo|Pill placebo
917365|NCT01037218|O4|Outcome|Placebo|Placebo tablets
907492|NCT01069523|O2|Outcome|Guanfacine|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907493|NCT01069523|O1|Outcome|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907494|NCT01069523|E2|Reported Event|Guanfacine Extended Release|Patients will be started on 1 mg of guanfacine extended release at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907495|NCT01069523|E1|Reported Event|Placebo|Patients will be started on 1 mg of guanfacine extended release matching placebo tablets at week 1. A physician blind to drug status will titrate the study medication in week 2-3 to a maximum of 4 mg (4 tablets).
907496|NCT01069484|B3|Baseline|Total|Total of all reporting groups
907497|NCT01069484|B2|Baseline|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention.
907498|NCT01069484|B1|Baseline|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months.
907499|NCT01069484|P2|Participant Flow|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the PFM correctly, the control group participants received no further intervention. They were not discouraged from doing PFMT on their own.
907500|NCT01069484|P1|Participant Flow|Postpartum Pelvic Floor Muscle Training|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract the pelvic floor muscle (PFM) correctly, the training participants attended a supervised exercise class once a week led by an experienced physiotherapist and were prescribed daily home training over a period of 4 months. The PFM exercise protocol followed general principles for strength training; 3 sets 8-12 contractions close to maximum (Bø et al 1990, Haskell 2007). The participants are provided with a DVD of the program (www.corewellness.co.uk). Training adherence at home was recorded in a training diary whereas the physical therapist recorded group session adherence. Training participants were continuously motivated by the physical therapist to keep up their adherence to training classes and home training, and high performance during training was strongly emphasised.
907501|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the control group received no further intervention..
907502|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
907503|NCT01069484|O2|Outcome|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
907545|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907546|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907504|NCT01069484|O1|Outcome|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
907505|NCT01069484|E2|Reported Event|Control|Beyond the customary leaflet (received from the postnatal ward) and the thorough initial instruction on how to contract correctly, the control group received no further intervention
907506|NCT01069484|E1|Reported Event|Postpartum Pelvic Floor Muscle Training|"Beyond the customary leaflet and the thorough initial instruction on how to contract correctly, the training group attended an exercise intervention for a period of 16 weeks (starting eight 8 weeks after delivery). Once a week the training participants attended a supervised exercise class led by an experienced physical therapist. The exercise class protocol is described in detail by Bø et al (1990) and Mørkved and Bø (1997). Additionally, the training group was prescribed to perform daily pelvic floor muscle training at home (three sets of 8-12 close to maximum contractions).~Training adherence at home was recorded in a training diary, whereas the physical therapist recorded group session adherence."
907507|NCT01069419|B1|Baseline|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
907508|NCT01069419|P1|Participant Flow|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
907509|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
907510|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
907511|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
907512|NCT01069419|O1|Outcome|Cimzia|All patients will be treated with Cimzia according to normal clinical practice for the prescribing physician and as defined by the SmPC
907514|NCT01069341|B1|Baseline|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
907515|NCT01069341|P1|Participant Flow|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
907516|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907517|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907518|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907519|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907520|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907521|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907522|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907523|NCT01069341|O1|Outcome|All Subjects|0.5 mg ranibizumab, intravitreal injection
907524|NCT01069341|E1|Reported Event|All Subjects With Treatment|All subjects received o.5 mg of ranibizumab injections monthly for 3 months
907525|NCT01069289|B3|Baseline|Total|Total of all reporting groups
907526|NCT01069289|B2|Baseline|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907527|NCT01069289|B1|Baseline|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907528|NCT01069289|P2|Participant Flow|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907529|NCT01069289|P1|Participant Flow|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907530|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907531|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907532|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907533|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907534|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907535|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907536|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907537|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907538|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907539|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907540|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907541|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907542|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907543|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907544|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
921568|NCT01026220|O3|Outcome|Group 5|RER PET-1 negative
907547|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907548|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907549|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907550|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907551|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907552|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907553|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907554|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907555|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907556|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907557|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907558|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907559|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907560|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907561|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907562|NCT01069289|O2|Outcome|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907563|NCT01069289|O1|Outcome|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907564|NCT01069289|E2|Reported Event|Oxis Turbuhaler (Active Comparator)|Oxis Turbuhaler 4.5 microgram (mcg), 2 inhalations twice daily(bid)
907565|NCT01069289|E1|Reported Event|Symbicort Turbuhaler (Experimental)|Symbicort Turbuhaler 160/4.5 microgram (mcg), 2 inhalations twice daily (bid)
907846|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
917366|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
907566|NCT01069172|B1|Baseline|FS Laser Surgery and CCC Surgery|"Each eye underwent either:~Femtosecond assissisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device (the Catalys System is used for FS Laser Surgery and is an ophthalmic surgical laser system intended for use in cataract surgery).~OR~Ultrasound (U/S) cataract surgery and CCC (continuous curvilinear capsulorhexis), subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
907567|NCT01069172|P2|Participant Flow|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC)~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
907568|NCT01069172|P1|Participant Flow|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
907569|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
907570|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
907571|NCT01069172|O2|Outcome|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC and U/S Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
907572|NCT01069172|O1|Outcome|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
907573|NCT01069172|E2|Reported Event|CCC Surgery|"Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).~CCC Surgery: Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens."
907574|NCT01069172|E1|Reported Event|FS Laser Surgery|"For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.~FS Laser Surgery: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery."
907575|NCT01069120|B3|Baseline|Total|Total of all reporting groups
907576|NCT01069120|B2|Baseline|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
907577|NCT01069120|B1|Baseline|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
907578|NCT01069120|P1|Participant Flow|Proellex®|25 or 50 mg capsules once per day
907579|NCT01069120|O2|Outcome|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
907580|NCT01069120|O1|Outcome|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
907581|NCT01069120|E2|Reported Event|25 mg Proellex®|Proellex: 1, 25 mg capsule once per day
907582|NCT01069120|E1|Reported Event|50 mg Proellex®|Proellex: 2, 25 mg capsules once per day
907583|NCT01069003|B4|Baseline|Total|Total of all reporting groups
907584|NCT01069003|B3|Baseline|Surveillance Arm|Non randomized subjects followed for total of 24 months
907614|NCT01068912|B1|Baseline|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
907615|NCT01068912|P3|Participant Flow|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
907585|NCT01069003|B2|Baseline|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
907586|NCT01069003|B1|Baseline|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
907587|NCT01069003|P3|Participant Flow|Surveillance Arm|Non randomized subjects followed for total of 24 months
907588|NCT01069003|P2|Participant Flow|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
907589|NCT01069003|P1|Participant Flow|Placebo|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
907590|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
907591|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
907592|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
907593|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
917367|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
907594|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
907595|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, myocardial ischemia, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
907596|NCT01069003|O3|Outcome|Surveillance Arm|Subjects followed for total of 24 months and not clear for randomization. Subjects who had a death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months prior to randomization.
907597|NCT01069003|O2|Outcome|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
907598|NCT01069003|O1|Outcome|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
907599|NCT01069003|E3|Reported Event|Surveillance Arm|Non randomized subjects followed through 24 months
907600|NCT01069003|E2|Reported Event|Thienopyridine Therapy|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of active thienopyridine and aspirin (ASA).~Prasugrel and Clopidogrel (30-Month Arm): Prasugrel 5 or 10 mg; Clopidogrel 75 mg~ASA: 75 mg - 325 mg Aspirin(ASA)"
907601|NCT01069003|E1|Reported Event|Placebo Arm|"Subjects without death, MI, stroke, repeat coronary revascularization, major bleeding or stent thrombosis in the first 12 months. These subjects are randomized to receive 18 months of placebo thienopyridine and aspirin (ASA).~Placebo (12-Month Arm): Placebo~ASA: 75 mg - 325 mg Aspirin(ASA)"
907602|NCT01068964|B3|Baseline|Total|Total of all reporting groups
907603|NCT01068964|B2|Baseline|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
907604|NCT01068964|B1|Baseline|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
907605|NCT01068964|P2|Participant Flow|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
907606|NCT01068964|P1|Participant Flow|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
907607|NCT01068964|O2|Outcome|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
907608|NCT01068964|O1|Outcome|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
907609|NCT01068964|E2|Reported Event|0.03% Bimatoprost and 0.5% Timolol in Separate Bottles|Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
907610|NCT01068964|E1|Reported Event|0.03% Bimatoprost/0.5% Timolol in Same Bottle|Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
907611|NCT01068912|B4|Baseline|Total|Total of all reporting groups
907612|NCT01068912|B3|Baseline|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
907613|NCT01068912|B2|Baseline|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
907616|NCT01068912|P2|Participant Flow|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
907617|NCT01068912|P1|Participant Flow|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
907618|NCT01068912|O3|Outcome|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
907619|NCT01068912|O2|Outcome|2: High Dose Favipiravir|Favipiravir:1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
907620|NCT01068912|O1|Outcome|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
907621|NCT01068912|E3|Reported Event|Placebo|Placebo comparator: Placebo BID x 1 day, and Placebo BID x 4 days
907622|NCT01068912|E2|Reported Event|2: High Dose Favipiravir|Favipiravir: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
907623|NCT01068912|E1|Reported Event|1: Low Dose Favipiravir|Favipiravir: 1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
907624|NCT01068860|B11|Baseline|Total|Total of all reporting groups
907625|NCT01068860|B10|Baseline|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907626|NCT01068860|B9|Baseline|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907627|NCT01068860|B8|Baseline|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907628|NCT01068860|B7|Baseline|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907847|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907629|NCT01068860|B6|Baseline|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907630|NCT01068860|B5|Baseline|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907631|NCT01068860|B4|Baseline|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907632|NCT01068860|B3|Baseline|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907633|NCT01068860|B2|Baseline|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907634|NCT01068860|B1|Baseline|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907635|NCT01068860|P10|Participant Flow|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907636|NCT01068860|P9|Participant Flow|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907637|NCT01068860|P8|Participant Flow|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907638|NCT01068860|P7|Participant Flow|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907639|NCT01068860|P6|Participant Flow|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907715|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907640|NCT01068860|P5|Participant Flow|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907641|NCT01068860|P4|Participant Flow|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907642|NCT01068860|P3|Participant Flow|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907643|NCT01068860|P2|Participant Flow|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907644|NCT01068860|P1|Participant Flow|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907645|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907646|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907647|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907648|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907649|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907650|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907651|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907652|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907653|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907654|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907655|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907656|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907657|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907658|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
921569|NCT01026220|O2|Outcome|Group 4|RER PET-1 positive
907659|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907660|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907661|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907662|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907663|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907664|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907848|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907665|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907666|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907667|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907668|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907669|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907670|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907671|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907672|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907673|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907674|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907675|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907676|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907677|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907678|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907679|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907680|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907681|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907682|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907849|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907850|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907683|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907684|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907685|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907686|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907687|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907688|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907689|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907690|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907691|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907692|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907693|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907694|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907695|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907696|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907697|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907698|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907699|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907700|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907701|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907702|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907703|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907704|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907705|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907706|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907707|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907708|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907709|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907710|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907711|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907712|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907713|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907714|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907882|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
921570|NCT01026220|O1|Outcome|Group 1|All Patients
907716|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907717|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907718|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907719|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907720|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
908364|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
907721|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907722|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907723|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907724|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907725|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907726|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907727|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907728|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907729|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907730|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907731|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907732|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907733|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907883|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
907884|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907734|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907735|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907736|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907737|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907738|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907775|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907739|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907740|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907741|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907742|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907743|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907744|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907745|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907746|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907747|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907748|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907749|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907750|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907751|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907885|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907886|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
921571|NCT01026220|O2|Outcome|Group 3|Regimen II
907752|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907753|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907754|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907755|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907756|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
917368|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
907757|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907758|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907759|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907760|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907761|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907762|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907763|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907764|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907765|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907766|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907767|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907768|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907769|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907770|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907771|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907772|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907773|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907774|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907842|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
917369|NCT01037218|O4|Outcome|Placebo|Placebo tablets
907776|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907777|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907778|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907779|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907780|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907781|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907782|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907783|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907784|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907785|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907786|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907787|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907788|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907789|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907887|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907790|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907791|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907792|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907793|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907843|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907794|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907795|NCT01068860|O10|Outcome|Placebo in Participants With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907796|NCT01068860|O9|Outcome|Canakinumab 150 mg in Participants With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907797|NCT01068860|O8|Outcome|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907798|NCT01068860|O7|Outcome|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907799|NCT01068860|O6|Outcome|Placebo + Met + Sulfonyl + Thiaz|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907800|NCT01068860|O5|Outcome|Canakinumab 150 mg Canakinumab 150 mg + Met + Sulfonyl + Thia|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907801|NCT01068860|O4|Outcome|Placebo + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907802|NCT01068860|O3|Outcome|Canakinumab 150 mg + Metformin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907803|NCT01068860|O2|Outcome|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907804|NCT01068860|O1|Outcome|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907805|NCT01068860|E10|Reported Event|Placebo in Patients With IGT|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907806|NCT01068860|E9|Reported Event|Canakinumab 150 mg in Patients With IGT|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had Impaired Glucose Tolerance (IGT) as defined by the World Health Organization (WHO) criteria confirmed at screening visit.
907807|NCT01068860|E8|Reported Event|Placebo + Insulin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
907808|NCT01068860|E7|Reported Event|Canakinumab 150 mg + Insulin|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus for 3 months prior to screening and be on a stable dose of Insulin, 2 insulin injections per day for a total daily dose of less than 100 U with or without Metformin (Met)for 3 months prior to screening
921572|NCT01026220|O1|Outcome|Group 2|Regimen 1
907809|NCT01068860|E6|Reported Event|Placebo + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907810|NCT01068860|E5|Reported Event|Canakinumab 150 mg + Met + Sulfonyl + Thiazolidinedione|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose, and a Thiazolidinedione (Thiaz)at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907811|NCT01068860|E4|Reported Event|Placebo + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907844|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907845|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907812|NCT01068860|E3|Reported Event|Canakinumab 150 mg + Metforimin + Sulfonylurea|Eligible participants received a single subcutaneous injection of Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) at least 1000 mg/day , and a Sulfonylurea (Sulfonyl), at least 1/2 the maximally labeled dose combination therapy, for 3 months prior to screening.
907813|NCT01068860|E2|Reported Event|Placebo + Metformin|Eligible participants received a single subcutaneous injection of Placebo to Canakinumab. Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907814|NCT01068860|E1|Reported Event|Canakinumab 150 mg + Metformin|Eligible participants received a single subcutaneous injection Canakinumab 150 mg.Patients must have had documented diagnosis of Type 2 Diabetes Mellitus and be on a stable dose of Metformin (Met) monotherapy treatment at least 1000 mg/day for 3 months prior to screening
907815|NCT01068821|B3|Baseline|Total|Total of all reporting groups
907816|NCT01068821|B2|Baseline|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
907817|NCT01068821|B1|Baseline|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
907818|NCT01068821|P2|Participant Flow|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
907819|NCT01068821|P1|Participant Flow|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
907820|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
907821|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
907822|NCT01068821|O2|Outcome|Gel Pad|Patient positioned on gel pad during surgery
907823|NCT01068821|O1|Outcome|Egg Crate Foam Mattress|Patient positioned on egg crate foam mattress during surgery
907824|NCT01068821|E2|Reported Event|Gel Pad|Patients will be placed on gel mattress instead of egg-crate foam mattress by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
907825|NCT01068821|E1|Reported Event|Egg Crate Foam Mattress|Patients will be placed on egg-crate foam mattress instead of a gel pad by randomization. All other positioning and measurements, including outcomes measures will be the same as for the the primary experimental intervention (gel pad).
907826|NCT01068769|B1|Baseline|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
907827|NCT01068769|P1|Participant Flow|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
907828|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
907829|NCT01068769|O1|Outcome|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
907830|NCT01068769|E1|Reported Event|Regorafenib|Regorafenib adminstered orally, 160 mg per day on days 1 through 21 of a 28 day cycle
907831|NCT01068743|B1|Baseline|All Enrolled and Treated Participants|
907832|NCT01068743|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment C (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment A (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment B (period 4): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition.
907833|NCT01068743|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment B (period 2): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment D (period 3): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment A (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition.
907834|NCT01068743|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment A (period 2): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment C (period 3): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition; Treatment D (period 4): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
907888|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907889|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907835|NCT01068743|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition; Treatment D (period 2): Fixed dose combination (FDC) tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition; Treatment B (period 3): FDC tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition; Treatment C (period 4): 2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fed condition.
907836|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907837|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907838|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907839|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907840|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907841|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907851|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907852|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907853|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907854|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907855|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907856|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907857|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907858|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907859|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907860|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907861|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907862|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907863|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907864|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907865|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907866|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907867|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907868|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907869|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907870|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907871|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907872|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907873|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907874|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907875|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907876|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907877|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907878|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907879|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907880|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition.
907881|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition.
909610|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
907890|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907891|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907892|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907893|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907894|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907895|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907896|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907897|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907898|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907899|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907900|NCT01068743|O4|Outcome|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907901|NCT01068743|O3|Outcome|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907902|NCT01068743|O2|Outcome|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907903|NCT01068743|O1|Outcome|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907904|NCT01068743|E4|Reported Event|Treatment D|FDC tablet (2.5 mg saxagliptin + metformin 850 mg) single dose under fed condition
907905|NCT01068743|E3|Reported Event|Treatment C|2.5 mg saxagliptin tablet and metformin 850 mg tablet single dose under fed condition
907906|NCT01068743|E2|Reported Event|Treatment B|Fixed dose combination (FDC) tablet (saxagliptin 2.5 mg + metformin 850 mg) single dose under fasted condition
907907|NCT01068743|E1|Reported Event|Treatment A|2.5 mg saxagliptin tablet + metformin 850 mg tablet single dose under fasted condition
907908|NCT01068730|B1|Baseline|All Enrolled and Treated Participants|Participants who were randomly assigned to 1 of 4 treatment sequences (ADBC, BACD, CBDA, or DCAB). Treatment A: single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment B: single oral 500-mg Glucophage tablet administered under fed condition. Treatment C: single oral 1000-mg Diabex tablet administered under fed condition.Treatment D: single oral 1000-mg Glucophage (metformin) tablet administered under fed condition.
907909|NCT01068730|P4|Participant Flow|Treatment Sequence DCAB|Treatment D (period 1): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment C (period 2): single oral 1000-mg Diabex tablet administered under fed condition. Treatment A (period 3): single oral 500-mg Diabex tablet administered under fed condition. Treatment B (period 4): single oral 500-mg Glucophage tablet administered under fed condition.
907910|NCT01068730|P3|Participant Flow|Treatment Sequence CBDA|Treatment C (period 1): single oral 1000-mg Diabex tablet administered under fed condition. Treatment B (period 2): single oral 500-mg Glucophage tablet administered under fed condition. Treatment D (period 3): single oral 1000-mg Glucophage tablet administered under fed condition. Treatment A (period 4): single oral 500-mg Diabex tablet administered under fed condition.
907911|NCT01068730|P2|Participant Flow|Treatment Sequence BACD|Treatment B (period 1): single oral 500-mg Glucophage tablet administered under fed condition. Treatment A (period 2): single oral 500-mg Diabex tablet administered under fed condition. Treatment C (period 3): single oral 1000-mg Diabex tablet administered under fed condition. Treatment D (period 4): single oral 1000-mg Glucophage tablet administered under fed condition.
907912|NCT01068730|P1|Participant Flow|Treatment Sequence ADBC|Treatment A (period 1): single oral 500-mg Diabex (metformin) tablet administered under fed condition. Treatment D (period 2): single oral 1000-mg Glucophage (metformin) tablet administered under fed condition. Treatment B (period 3): single oral 500-mg Glucophage tablet administered under fed condition. Treatment C (period 4): single oral 1000-mg Diabex tablet administered under fed condition.
907913|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
907914|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907915|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907916|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907917|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
907918|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907919|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907920|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907921|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
907922|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907923|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907924|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907925|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
907926|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907927|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907928|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907929|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
907930|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907931|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907932|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907933|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
907934|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907935|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907936|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907937|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
907938|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907939|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907940|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907941|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single oral dose of 1000 mg Glucophage tablet administered in the fed condition
908365|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
907942|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single oral dose of 1000 mg Diabex tablet administered in the fed condition
907943|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single oral dose of 500 mg Glucophage tablet administered in the fed condition
907944|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single oral dose of 500 mg Diabex tablet administered in the fed condition
907945|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
907946|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
907947|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
907948|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
907949|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
907950|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
907951|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
907952|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
907953|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
907954|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
907955|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
907956|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
907957|NCT01068730|O4|Outcome|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
907958|NCT01068730|O3|Outcome|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
907959|NCT01068730|O2|Outcome|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
907960|NCT01068730|O1|Outcome|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
907961|NCT01068730|E4|Reported Event|Treatment B - 500 mg Glucophage|500 mg metformin (Glucophage™): Single Oral dose of 500 mg Glucophage tablet administered in the fed condition
907962|NCT01068730|E3|Reported Event|Treatment A - 500 mg Diabex|500 mg metformin (Diabex): Single Oral dose of 500 mg Diabex tablet administered in the fed condition
907963|NCT01068730|E2|Reported Event|Treatment D - 1000 mg Glucophage|1000 mg metformin (Glucophage™): Single Oral dose of 1000 mg Glucophage tablet administered in the fed condition
907964|NCT01068730|E1|Reported Event|Treatment C - 1000 mg Diabex|1000 mg metformin (Diabex): Single Oral dose of 1000 mg Diabex tablet administered in the fed condition
907965|NCT01068717|B1|Baseline|All Treated|All participants who received study medication.
907987|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907988|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
907966|NCT01068717|P4|Participant Flow|Treatment Schedule DCAB|(Treatment D) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500- mg metformin FDC administered in the fasted state.
907967|NCT01068717|P3|Participant Flow|Treatment Schedule CBDA|(Treatment C) A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fed state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state.
907968|NCT01068717|P2|Participant Flow|Treatment Schedule BACD|(Treatment B) A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment A) a single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the fasted state.
907969|NCT01068717|P1|Participant Flow|Treatment Schedule ADBC|(Treatment A) A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment D) a single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment B) a single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC in the fasted state, followed by a 7-day (minimum) washout period. Then, (Treatment C) a single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fed state.
917370|NCT01037218|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
907970|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907971|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907972|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
907973|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
907974|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907975|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907976|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
907977|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
907978|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907979|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907980|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
907981|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
907982|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907983|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907984|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
907985|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
907986|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907989|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
907990|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907991|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907992|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
907993|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
907994|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907995|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907996|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
907997|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
917371|NCT01037218|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
907998|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
907999|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908000|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
908001|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
908002|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908003|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908004|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
908005|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
908006|NCT01068717|O4|Outcome|Treatment D: Saxagliptin/Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908007|NCT01068717|O3|Outcome|Treatment C: Saxagliptin + Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908008|NCT01068717|O2|Outcome|Treatment B: Saxagliptin/Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
908009|NCT01068717|O1|Outcome|Treatment A: Saxagliptin + Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
908010|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908011|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908012|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
908013|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
908014|NCT01068717|O4|Outcome|Treatment D: Saxagliptin and Metformin FDC, Fed|A single oral dose of 2.5-mg saxagliptin/500-mg metformin FDC administered in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
921573|NCT01026220|O1|Outcome|Group 1|All Patients
908015|NCT01068717|O3|Outcome|Treatment C: Saxagliptin and Metformin Tablets, Fed|A single oral dose of saxagliptin 2.5-mg and metformin 500-mg tablets administered together in the morning within 5 minutes of completing a standard high-fat, high-calorie breakfast (fed state), followed by a 7-day (minimum) washout period.
908016|NCT01068717|O2|Outcome|Treatment B: Saxagliptin and Metformin FDC, Fasted|A single oral dose of 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC) administered in the fasted state, followed by a 7-day (minimum) washout period.
908017|NCT01068717|O1|Outcome|Treatment A: Saxagliptin and Metformin Tablets, Fasted|A single oral dose of saxagliptin, 2.5-mg and metformin 500-mg tablets administered together in the fasted state, followed by a 7-day (minimum) washout period.
908018|NCT01068717|E4|Reported Event|Fed: 2.5mg Saxa/500mg Metformin FDC|
908019|NCT01068717|E3|Reported Event|Fed: 2.5mg Onglyza + 500mg Glucophage|
908020|NCT01068717|E2|Reported Event|Fasted: 2.5mg Saxa/500mg Metformin FDC|
908021|NCT01068717|E1|Reported Event|Fasted: 2.5mg Onglyza + 500mg Glucophage|
908022|NCT01068678|B3|Baseline|Total|Total of all reporting groups
908023|NCT01068678|B2|Baseline|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908024|NCT01068678|B1|Baseline|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908025|NCT01068678|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908026|NCT01068678|P1|Participant Flow|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908027|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908028|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908029|NCT01068678|O2|Outcome|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908030|NCT01068678|O1|Outcome|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908031|NCT01068678|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) 100U/mL given once a day (OD), according to the labelling instructions with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908032|NCT01068678|E1|Reported Event|IDeg 3TW|Insulin degludec (IDeg) 200U/mL given 3 times weekly (Mondays, Wednesdays, Fridays) in the morning with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908033|NCT01068665|B3|Baseline|Total|Total of all reporting groups
908034|NCT01068665|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908035|NCT01068665|B1|Baseline|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908036|NCT01068665|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908037|NCT01068665|P1|Participant Flow|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908038|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908039|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908040|NCT01068665|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908041|NCT01068665|O1|Outcome|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908042|NCT01068665|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908043|NCT01068665|E1|Reported Event|IDeg 200 U/mL OD|Insulin degludec (IDeg) 200U/mL was given once daily (OD) subcutaneously with the main evening meal in combination with metformin with or without dipeptidyl peptidase-4 (DPP-4) inhibitor treatment for 26 weeks.
908044|NCT01068652|B3|Baseline|Total|Total of all reporting groups
908045|NCT01068652|B2|Baseline|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908061|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908046|NCT01068652|B1|Baseline|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908047|NCT01068652|P2|Participant Flow|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908048|NCT01068652|P1|Participant Flow|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908049|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908050|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908366|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
908051|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908052|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908053|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908054|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908055|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908056|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908057|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908058|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908059|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908060|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908143|NCT01068418|P1|Participant Flow|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
908144|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
908062|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908063|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908064|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908065|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908066|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908067|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908068|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908069|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908070|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908071|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908072|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908073|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908074|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908075|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908076|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908111|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908077|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908078|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908079|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908080|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908081|NCT01068652|O2|Outcome|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908082|NCT01068652|O1|Outcome|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908083|NCT01068652|E2|Reported Event|BIAsp 30 + Met|Individually adjusted biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously (s.c.) in the abdomen at dinner at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, the dose was intensified up to 3 doses daily, injected s.c. (under the skin) if treatment target of HbA1c below 7.0% was not reached.
908084|NCT01068652|E1|Reported Event|Detemir + Met|Individually adjusted insulin detemir (Detemir) was given subcutaneoulsy (s.c.) at bedtime in the thigh at an initial dose of 0.1 U/kg once daily for 50 weeks in combination with 1000-2000 mg/day metformin (Met). Pending evaluation of HbA1c every 3 months, individually adjusted insulin aspart was added to the insulin detemir treatment (up to three doses daily for maximum 36 weeks, injected s.c. [under the skin]) if treatment target of HbA1c below 7.0% was not reached.
908085|NCT01068626|B3|Baseline|Total|Total of all reporting groups
908086|NCT01068626|B2|Baseline|Placebo for Rosuvastatin|
908087|NCT01068626|B1|Baseline|Rosuvastatin|
908088|NCT01068626|P2|Participant Flow|Placebo for Rosuvastatin|
908089|NCT01068626|P1|Participant Flow|Rosuvastatin|
908090|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
908091|NCT01068626|O1|Outcome|Rosuvastatin|
908092|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
908093|NCT01068626|O1|Outcome|Rosuvastatin|
908094|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
908095|NCT01068626|O1|Outcome|Rosuvastatin|
908096|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
908097|NCT01068626|O1|Outcome|Rosuvastatin|
908098|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
908099|NCT01068626|O1|Outcome|Rosuvastatin|
908100|NCT01068626|O2|Outcome|Placebo for Rosuvastatin|
908101|NCT01068626|O1|Outcome|Rosuvastatin|
908102|NCT01068626|E2|Reported Event|Placebo for Rosuvastatin|
908103|NCT01068626|E1|Reported Event|Rosuvastatin|
908104|NCT01068600|B3|Baseline|Total|Total of all reporting groups
908105|NCT01068600|B2|Baseline|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908106|NCT01068600|B1|Baseline|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908107|NCT01068600|P2|Participant Flow|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908108|NCT01068600|P1|Participant Flow|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908109|NCT01068600|O2|Outcome|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908110|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908112|NCT01068600|O1|Outcome|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908113|NCT01068600|E2|Reported Event|Placebo|Placebo to indacaterol inhaled once daily in the morning via Concept1, a SDDPI, for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908114|NCT01068600|E1|Reported Event|Indacaterol 75 µg|Indacaterol 75 µg inhaled once daily in the morning via Concept1, a single dose dry powder inhaler (SDDPI), for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) albuterol was available for rescue use throughout the study.
908115|NCT01068548|B3|Baseline|Total|Total of all reporting groups
908116|NCT01068548|B2|Baseline|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
908117|NCT01068548|B1|Baseline|Arm 1|pre-implementation of computer based intervention
908118|NCT01068548|P2|Participant Flow|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
908119|NCT01068548|P1|Participant Flow|Arm 1|pre-implementation of computer based intervention
908120|NCT01068548|O2|Outcome|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
908121|NCT01068548|O1|Outcome|Arm 1|pre-implementation of computer based intervention
908367|NCT01067326|E2|Reported Event|Placebo|1 pill per day by mouth for 4 months.
908122|NCT01068548|E2|Reported Event|Arm 2|"post-implementation of computer based intervention~reminder: computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines"
908123|NCT01068548|E1|Reported Event|Arm 1|pre-implementation of computer based intervention
908124|NCT01068509|B4|Baseline|Total|Total of all reporting groups
908125|NCT01068509|B3|Baseline|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
908126|NCT01068509|B2|Baseline|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
908127|NCT01068509|B1|Baseline|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
908128|NCT01068509|P3|Participant Flow|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
908129|NCT01068509|P2|Participant Flow|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
908130|NCT01068509|P1|Participant Flow|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
908131|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
908132|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
908133|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
908134|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
908135|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
908136|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
908137|NCT01068509|O2|Outcome|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
908138|NCT01068509|O1|Outcome|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
908139|NCT01068509|E3|Reported Event|Observational Standard of Care|Participants in this group did not receive any treatment during the study.
908140|NCT01068509|E2|Reported Event|Randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs every 4 weeks for 24 weeks (7 doses at Weeks 8, 12, 16, 20, 24, 28, and 32), and then every 8 weeks for 24 weeks (3 doses at Weeks 40, 48, and 56). The 6-8 injections contained ~ 60 × 10^6 dendritic cells.
908141|NCT01068509|E1|Reported Event|Non-randomized Cvac|Participants received 6-8 intradermal injections of Cvac at 4 sites along both upper arms and both thighs. The 6-8 injections contained ~ 60 × 10^6 dendritic cells. Following evaluation after the first dose, participants received additional injections as described for the randomized Cvac group below.
908142|NCT01068418|B1|Baseline|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
908145|NCT01068418|O1|Outcome|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
908146|NCT01068418|E1|Reported Event|Vitamin D3|This was a single-arm open-label study where participants received 15,000IU of vitamin D3 daily for 4 weeks.
908147|NCT01068262|B5|Baseline|Total|Total of all reporting groups
908148|NCT01068262|B4|Baseline|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
908149|NCT01068262|B3|Baseline|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908150|NCT01068262|B2|Baseline|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
908151|NCT01068262|B1|Baseline|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908152|NCT01068262|P4|Participant Flow|Healthy Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
908153|NCT01068262|P3|Participant Flow|Healthy Postmenopausal Females: Odanacatib (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908154|NCT01068262|P2|Participant Flow|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks.
908155|NCT01068262|P1|Participant Flow|Healthy Males: Odanacatib (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered once weekly (Qw) for 4 consecutive weeks
908156|NCT01068262|O4|Outcome|Placebo in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
908157|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908158|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
908159|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908160|NCT01068262|O4|Outcome|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
908161|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908162|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
908163|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908164|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908165|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908166|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908167|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908168|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908169|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908170|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908171|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908172|NCT01068262|O2|Outcome|Odanacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908173|NCT01068262|O1|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908174|NCT01068262|O4|Outcome|Placebo in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of placebo administered Qw for 4 consecutive weeks
908175|NCT01068262|O3|Outcome|Odnacatib (MK-0822) in Postmenopausal Females (Panel B)|Healthy postmenopausal females received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908176|NCT01068262|O2|Outcome|Placebo in Males (Panel A)|Healthy males received oral doses of placebo administered Qw for 4 consecutive weeks
908177|NCT01068262|O1|Outcome|Odanacatib (MK-0822) in Males (Panel A)|Healthy males received oral doses of Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908178|NCT01068262|E4|Reported Event|Postmenopausal Females: Placebo (Panel B)|Healthy postmenopausal female participants randomized to placebo administered Qw for 4 consecutive weeks
908179|NCT01068262|E3|Reported Event|Postmenopausal Females: Odanacatib 50 mg (Panel B)|Healthy postmenopausal female participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908180|NCT01068262|E2|Reported Event|Healthy Males: Placebo (Panel A)|Healthy male participants randomized to placebo administered Qw for 4 consecutive weeks
908181|NCT01068262|E1|Reported Event|Healthy Males: Odanacatib 50 mg (Panel A)|Healthy male participants randomized to Odanacatib 50 mg tablet administered Qw for 4 consecutive weeks
908182|NCT01068158|B3|Baseline|Total|Total of all reporting groups
908183|NCT01068158|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
921574|NCT01026220|O1|Outcome|Group 1|All Patients
908185|NCT01068158|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908186|NCT01068158|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908187|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908188|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908189|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908190|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908191|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908192|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908193|NCT01068158|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908194|NCT01068158|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908195|NCT01068158|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908196|NCT01068158|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908292|NCT01067768|E1|Reported Event|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
908197|NCT01067976|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
908198|NCT01067976|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection (i.v.) at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
908199|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
908200|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|
908201|NCT01067976|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participants first received an unenhanced MRM, followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg bw [0.1 ml/kg bw] as an i.v. injection at a rate of 2 ml/sec. UMRM and CMRM image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective XRM was added and evaluated together with the UMRM images.
908202|NCT01067976|O1|Outcome|CMRM|
908203|NCT01067976|O1|Outcome|CMRM|
908204|NCT01067976|O1|Outcome|CMRM|
908205|NCT01067976|O1|Outcome|CMRM vs UMRM|
908206|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908207|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908208|NCT01067976|O1|Outcome|CMRM vs UMRM|
908209|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908210|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908211|NCT01067976|O1|Outcome|CMRM vs UMRM|
908212|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908213|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908214|NCT01067976|O1|Outcome|CMRM vs UMRM|
908215|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908216|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908217|NCT01067976|O1|Outcome|CMRM vs UMRM|
908218|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908219|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908220|NCT01067976|O1|Outcome|CMRM vs UMRM|
908221|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908222|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908223|NCT01067976|O1|Outcome|CMRM vs UMRM|
908224|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908225|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908226|NCT01067976|O1|Outcome|CMRM vs UMRM|
908227|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908228|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908229|NCT01067976|O1|Outcome|CMRM vs UMRM|
908230|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908231|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908232|NCT01067976|O1|Outcome|CMRM vs UMRM|
908233|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908234|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908235|NCT01067976|O1|Outcome|CMRM vs UMRM|
908236|NCT01067976|O3|Outcome|CMRM+XRM vs XRM|
908237|NCT01067976|O2|Outcome|CMRM+XRM vs UMRM+XRM|
908238|NCT01067976|O1|Outcome|CMRM vs UMRM|
908239|NCT01067976|O5|Outcome|CMRM+XRM|
908240|NCT01067976|O4|Outcome|UMRM+XRM|
908241|NCT01067976|O3|Outcome|X-ray Mammography (XRM)|
908242|NCT01067976|O2|Outcome|CMRM|After the administration of study drug, enhanced breast MRI were performed.
908243|NCT01067976|O1|Outcome|UMRM|Before the administration of study drug unenhanced breast MRI (UMRM) were performed.
908244|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
908245|NCT01067976|O2|Outcome|CMRM vs XRM|
908246|NCT01067976|O1|Outcome|CMRM vs UMRM|
908247|NCT01067976|O3|Outcome|CMRM vs CMRM+XRM|
908248|NCT01067976|O2|Outcome|CMRM vs XRM|
908249|NCT01067976|O1|Outcome|CMRM vs UMRM|
908250|NCT01067976|O1|Outcome|CMRM|
908255|NCT01067976|E1|Reported Event|Gadobutrol (Gadavist, BAY 86-4875)|Participants first received an unenhanced magnetic resonance mammography (MRM), followed by a gadobutrol-enhanced MRM. Gadobutrol was administered at the standard dose of 0.1 mmol/kg body weight (bw) [0.1 ml/kg bw] as an intravenous injection at a rate of 2 ml/sec. Unenhanced MRM (UMRM) and combined unenhanced and contrast (gadobutrol)-enhanced MRM (CMRM) image sets were evaluated in a randomized fashion. After the evaluation of the UMRM or CMRM the respective X-ray mammography (XRM) was added and evaluated together with the UMRM images.
908256|NCT01067846|B3|Baseline|Total|Total of all reporting groups
908257|NCT01067846|B2|Baseline|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908258|NCT01067846|B1|Baseline|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908259|NCT01067846|P2|Participant Flow|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908260|NCT01067846|P1|Participant Flow|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908261|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908262|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908263|NCT01067846|O2|Outcome|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908264|NCT01067846|O1|Outcome|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908265|NCT01067846|E2|Reported Event|Placebo and Cognitive Behavioral Therapy|"Subjects will receive a 250 mg identical looking placebo pill prior to computerized cognitive behavioral therapy.~Placebo : Placebo identical looking to the 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908266|NCT01067846|E1|Reported Event|DCS and Cognitive Behavioral Therapy|"Subjects will receive 250 mg of Seromycin or D-cycloserine (DCS) prior to computerized cognitive behavioral therapy.~Seromycin (D-cycloserine, DCS) : 250 mg DCS once weekly for 4 weeks prior to the initiation of a Computerized Cognitive Behavioral Therapy (CBT) session for drug relapse intervention."
908267|NCT01067781|B5|Baseline|Total|Total of all reporting groups
908268|NCT01067781|B4|Baseline|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
908269|NCT01067781|B3|Baseline|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
908270|NCT01067781|B2|Baseline|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
908271|NCT01067781|B1|Baseline|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
908272|NCT01067781|P4|Participant Flow|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
908273|NCT01067781|P3|Participant Flow|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
908274|NCT01067781|P2|Participant Flow|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
908275|NCT01067781|P1|Participant Flow|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
908276|NCT01067781|O2|Outcome|Group 3 & 4 Combined: Placebo Patch (0µg LT)|with or without swabbing
908277|NCT01067781|O1|Outcome|Group 1 & 2 Combined: 37.5µg LT Patch|with or without swabbing
908278|NCT01067781|E4|Reported Event|Group 4: 0μg LT, Swab|"Two vaccination regimen with a placebo patch (with swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
908279|NCT01067781|E3|Reported Event|Group 3: 0μg LT, No Swab|"Two vaccination regimen with a placebo patch (no swabbing)~Placebo: Travelers' Diarrhea Vaccine System"
908280|NCT01067781|E2|Reported Event|Group 2: 37.5μg LT, Swab|"Two vaccination regimen with an LT patch (with swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
908281|NCT01067781|E1|Reported Event|Group 1: 37.5μg LT, No Swab|"Two vaccination regimen with an LT patch (no swabbing)~Heat-Labile Enterotoxin of E. coli (LT): Travelers' Diarrhea Vaccine System"
908282|NCT01067768|B3|Baseline|Total|Total of all reporting groups
908283|NCT01067768|B2|Baseline|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
909611|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
908284|NCT01067768|B1|Baseline|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
908285|NCT01067768|P2|Participant Flow|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
908286|NCT01067768|P1|Participant Flow|Daily Review|In the intervention group a nurse reviewed daily, by using a checklist designed for this study, the indications and pertinence of the catheter. If it was not indicated she asked the doctor to order the removal of the catheter, but the doctor would make the final decision.
908287|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
908288|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
908289|NCT01067768|O2|Outcome|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
908290|NCT01067768|O1|Outcome|Daily Review|Daily monitoring of catheter indication
908291|NCT01067768|E2|Reported Event|Control Group|In the control group, the attending team would remove the catheter as routine, without any suggestion by the research protocol.
908293|NCT01067716|B4|Baseline|Total|Total of all reporting groups
908368|NCT01067326|E1|Reported Event|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
908294|NCT01067716|B3|Baseline|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
908295|NCT01067716|B2|Baseline|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
908296|NCT01067716|B1|Baseline|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
908297|NCT01067716|P3|Participant Flow|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
908298|NCT01067716|P2|Participant Flow|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
908299|NCT01067716|P1|Participant Flow|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
908300|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
908301|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
908302|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
908303|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
908304|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
908305|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
908306|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
908307|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
908308|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
908309|NCT01067716|O3|Outcome|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
908310|NCT01067716|O2|Outcome|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
908311|NCT01067716|O1|Outcome|Myopia With and Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
908312|NCT01067716|E3|Reported Event|Mixed Astigmatism|Mixed Astigmatism when the magnitude of cylinder (from 1.0 to 6.0D) is greater than the magnitude of sphere, and the cylinder and sphere have opposite signs.
908313|NCT01067716|E2|Reported Event|Hyperopia With and Without Astigmatism|Hyperopia with and without astigmatism with MRSE up to +9.00 D, with cylinder between 0.00 and +6.00 D.
908314|NCT01067716|E1|Reported Event|Myopia With or Without Astigmatism|Myopia with and without astigmatism with MRSE up to -15.0D, with cylinder between 0.00 and -6.00 D.
908315|NCT01067456|B3|Baseline|Total|Total of all reporting groups
908316|NCT01067456|B2|Baseline|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic Dual Source CT (DSCT) arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
908317|NCT01067456|B1|Baseline|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
908318|NCT01067456|P2|Participant Flow|Comprehensive Cardiothoracic CT Arm|Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
908319|NCT01067456|P1|Participant Flow|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
908320|NCT01067456|O2|Outcome|Comprehensive Cardiothoracic CT Arm|"Subjects in this arm receive a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.~Comprehensive Cardiothoracic DSCT arm: Subjects in this arm will receive the comprehensive cardiothoracic DSCT to rule out aortic dissection/pulmonary embolism/acute coronary syndrome in a single scan."
908321|NCT01067456|O1|Outcome|Dedicated CT Arm|Subjects in this arm will continue to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
908322|NCT01067456|E2|Reported Event|Comprehensive Cardiothoracic CT Arm|Subjects in this arm received a comprehensive cardiothoracic CT to evaluate the presence of acute coronary syndrome/aortic dissection/pulmonary embolism in a single scan.
908323|NCT01067456|E1|Reported Event|Dedicated CT Arm|Subjects in this arm continued to receive standard of care - that is the dedicated CT protocol to rule out either aortic dissection or acute coronary syndrome or pulmonary embolism.
908324|NCT01067352|B4|Baseline|Total|Total of all reporting groups
908325|NCT01067352|B3|Baseline|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908326|NCT01067352|B2|Baseline|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908362|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
908363|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
908327|NCT01067352|B1|Baseline|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
908328|NCT01067352|P3|Participant Flow|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908329|NCT01067352|P2|Participant Flow|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908330|NCT01067352|P1|Participant Flow|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
908331|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908332|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908333|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
908334|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908335|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908336|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
908337|NCT01067352|O3|Outcome|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908338|NCT01067352|O2|Outcome|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908339|NCT01067352|O1|Outcome|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
908340|NCT01067352|E3|Reported Event|Group B, More Than Third Percentile (No Treatment)|Participants with more than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908341|NCT01067352|E2|Reported Event|Group A2, Less Than Third Percentile (No Treatment)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received no drug treatment for 2 years.
908342|NCT01067352|E1|Reported Event|Group A, Less Than Third Percentile (Saizen)|Participants with less than third percentile for height (according to the Tanner reference table) at the age of 4-6 years received Saizen (recombinant human growth hormone, r-hGH) subcutaneously (s.c) at the daily dose of 0.035 milligram(mg)/kilogram(kg) for 2 years.
908343|NCT01067339|B3|Baseline|Total|Total of all reporting groups
908344|NCT01067339|B2|Baseline|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
908345|NCT01067339|B1|Baseline|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
908346|NCT01067339|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
908347|NCT01067339|P1|Participant Flow|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
908348|NCT01067339|O2|Outcome|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
908349|NCT01067339|O1|Outcome|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
908350|NCT01067339|O2|Outcome|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
908351|NCT01067339|O1|Outcome|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
908352|NCT01067339|E2|Reported Event|Placebo|Subjects randomized to this arm will receive a placebo tablet matching the study drug, once per day for 6 months.
908353|NCT01067339|E1|Reported Event|Darapladib|Subjects randomized to this arm will receive a darapladib tablet, 160 mg, by mouth, once per day for 6 months.
908354|NCT01067326|B3|Baseline|Total|Total of all reporting groups
908355|NCT01067326|B2|Baseline|Placebo|"1 pill per day by mouth for 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
908356|NCT01067326|B1|Baseline|Aliskiren|"150 mg Aliskiren once daily for a period of 4 months. Not all baseline data were available from started subjects, therefore only baseline data for completed subjects is presented."
908357|NCT01067326|P2|Participant Flow|Placebo|1 pill per day by mouth for 4 months.
908358|NCT01067326|P1|Participant Flow|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
908359|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
908360|NCT01067326|O1|Outcome|Aliskiren|150 mg Aliskiren once daily for a period of 4 months.
908361|NCT01067326|O2|Outcome|Placebo|1 pill per day by mouth for 4 months.
908369|NCT01067105|B1|Baseline|Ciclesonide|ciclesonide HFA 160 μg once daily
908370|NCT01067105|P1|Participant Flow|Ciclesonide|ciclesonide HFA 160 μg once daily
908371|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908372|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908373|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908374|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908375|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908376|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908377|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908378|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908379|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908380|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908381|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908382|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908383|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908384|NCT01067105|O1|Outcome|Ciclesonide|ciclesonide HFA 160 μg once daily
908385|NCT01067105|E1|Reported Event|Ciclesonide|ciclesonide HFA 160 μg once daily
908386|NCT01066923|B5|Baseline|Total|Total of all reporting groups
908387|NCT01066923|B4|Baseline|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
908388|NCT01066923|B3|Baseline|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
908389|NCT01066923|B2|Baseline|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
908390|NCT01066923|B1|Baseline|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
908391|NCT01066923|P4|Participant Flow|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
908392|NCT01066923|P3|Participant Flow|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
908393|NCT01066923|P2|Participant Flow|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
908438|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908394|NCT01066923|P1|Participant Flow|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
908395|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
908396|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
908397|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
908398|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
908399|NCT01066923|O4|Outcome|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
908400|NCT01066923|O3|Outcome|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
908401|NCT01066923|O2|Outcome|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
908402|NCT01066923|O1|Outcome|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
908403|NCT01066923|E4|Reported Event|Daily Placebo, Passive Cool, Acute Placebo|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, placebo immediately post exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy~Acute placebo: Placebo comparator for acute aspirin therapy"
908404|NCT01066923|E3|Reported Event|Daily Placebo, Passive Cool, Acute ASA|"Two weeks of daily placebo prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise~Daily placebo: Placebo comparator for daily aspirin therapy"
908405|NCT01066923|E2|Reported Event|Daily ASA, Passive Cool, Acute Placebo|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, placebo immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Passive cooling: Removing protective garments for passive cooling following exercise~Acute placebo: Placebo comparator for acute aspirin therapy"
908406|NCT01066923|E1|Reported Event|Daily ASA, Passive Cool, Acute ASA|"Two weeks of daily aspirin therapy prior to exercise, passive cooling following exercise, aspirin immediately post exercise~Daily aspirin (ASA): Two weeks 82 mg aspirin taken orally prior to exercise protocol~Acute aspirin (ASA): 325 mg chewable aspirin administered immediately following exercise~Passive cooling: Removing protective garments for passive cooling following exercise"
908407|NCT01066897|B3|Baseline|Total|Total of all reporting groups
908408|NCT01066897|B2|Baseline|Healthy Controls|Non depressed, non treatment comparison group from baseline
908409|NCT01066897|B1|Baseline|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
908410|NCT01066897|P2|Participant Flow|Healthy Controls|Non depressed, non treatment comparison group
908411|NCT01066897|P1|Participant Flow|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
908412|NCT01066897|O2|Outcome|Healthy Controls|Non depressed, non treatment comparison group
908413|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
908414|NCT01066897|O2|Outcome|Healthy Controls|Non depressed, non-intervention comparison group
908415|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
908416|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
908417|NCT01066897|O2|Outcome|Healthy Controls Who Did Not Take Medication|
908858|NCT01066104|O2|Outcome|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908418|NCT01066897|O1|Outcome|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
908419|NCT01066897|E1|Reported Event|Pramipexole|"Patients will receive 0.125 mg of pramipexole three times a day for the first week, 0.25 mg three times a day for the second week, and 0.5 mg three times a day for the third week. The dose will then be adjusted as needed by the treating physician (Dr. DeBattista), with a target range of 1.0 mg to 1.5 mg per day. Dose escalations will continue until 1) achievement of the primary endpoint (> 50% reduction from baseline on the HDRS scores; 2) intolerable side effects; or 3) completion of the 8-week study. Participants will be seen weekly the first four weeks and biweekly thereafter. Side effects, depression, and anhedonia will assessed at each visit.~Pramipexole: Patients will received increasing dose of pramipexole"
908420|NCT01066871|B5|Baseline|Total|Total of all reporting groups
908421|NCT01066871|B4|Baseline|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908422|NCT01066871|B3|Baseline|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908423|NCT01066871|B2|Baseline|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908424|NCT01066871|B1|Baseline|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908425|NCT01066871|P4|Participant Flow|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908426|NCT01066871|P3|Participant Flow|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908427|NCT01066871|P2|Participant Flow|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908428|NCT01066871|P1|Participant Flow|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908429|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908430|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908431|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908432|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908433|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908434|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908435|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908436|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908437|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
921575|NCT01026220|O1|Outcome|Group 1|All Patients
908439|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908440|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908441|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908442|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908443|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908444|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908445|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908446|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908447|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908448|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908449|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908450|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908451|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908452|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908453|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908454|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908455|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908456|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908457|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908458|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908459|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908460|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908461|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908462|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908463|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908464|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908465|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908466|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908467|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908468|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908469|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908470|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908471|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908472|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908473|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin AS902330 was administered as intra-articular injection once every week for 3 consecutive weeks.
908474|NCT01066871|O3|Outcome|AS902330 100 mcg|AS902330 was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908475|NCT01066871|O2|Outcome|AS902330 30 mcg|AS902330 was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908812|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908476|NCT01066871|O1|Outcome|AS902330 10 mcg|AS902330 was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908477|NCT01066871|O4|Outcome|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908478|NCT01066871|O3|Outcome|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908479|NCT01066871|O2|Outcome|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908480|NCT01066871|O1|Outcome|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was be administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908481|NCT01066871|E4|Reported Event|Placebo|Placebo matched to sprifermin (AS902330) was administered as intra-articular injection once every week for 3 consecutive weeks.
908482|NCT01066871|E3|Reported Event|Sprifermin (AS902330) 100 mcg|Sprifermin (AS902330) was administered at a dose of 100 mcg as intra-articular injection once every week for 3 consecutive weeks.
908483|NCT01066871|E2|Reported Event|Sprifermin (AS902330) 30 mcg|Sprifermin (AS902330) was administered at a dose of 30 mcg as intra-articular injection once every week for 3 consecutive weeks.
908484|NCT01066871|E1|Reported Event|Sprifermin (AS902330) 10 mcg|Sprifermin (AS902330) was administered at a dose of 10 microgram (mcg) as intra-articular injection once every week for 3 consecutive weeks.
908485|NCT01066819|B7|Baseline|Total|Total of all reporting groups
908486|NCT01066819|B6|Baseline|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908859|NCT01066104|O1|Outcome|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908487|NCT01066819|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908488|NCT01066819|B4|Baseline|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908489|NCT01066819|B3|Baseline|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908490|NCT01066819|B2|Baseline|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908491|NCT01066819|B1|Baseline|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908492|NCT01066819|P6|Participant Flow|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908493|NCT01066819|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908494|NCT01066819|P4|Participant Flow|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908495|NCT01066819|P3|Participant Flow|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908496|NCT01066819|P2|Participant Flow|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908497|NCT01066819|P1|Participant Flow|Genotype 1 (G1)|Eligible participants with serologically proven Chronic hepatitis C (CHC) (Genotype 1) who received Pegylated Interferon (PEG-IFN) alfa-2a (PEGASYS®) or PEG-IFN alfa-2b (PegIntron®) plus ribavirin for up to 48 weeks according to the standard of care and in line with summaries of product characteristics (SPCs)/local labeling were observed.
908498|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908499|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908500|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908501|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908502|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908503|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908813|NCT01066585|E2|Reported Event|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
909787|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
908504|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908505|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908506|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908507|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908508|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908509|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908510|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908860|NCT01066104|O2|Outcome|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908511|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908512|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908513|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908514|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908515|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908516|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908517|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908518|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908519|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908520|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908521|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908522|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908523|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908524|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908525|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908526|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908527|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908528|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908529|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908530|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908531|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908532|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908533|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908534|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908535|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908536|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908537|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908538|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908539|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908540|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908541|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908542|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908543|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908544|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908545|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908546|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908547|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908548|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908549|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908550|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908551|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908552|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908553|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908554|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908555|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908556|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908557|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908558|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908559|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908560|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908561|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908562|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908563|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908564|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908565|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908566|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908567|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908568|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908569|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908570|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908571|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908572|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908573|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908574|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908575|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908576|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908577|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908578|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908579|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908580|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908581|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908582|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908583|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908584|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908585|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908586|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908587|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908588|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908589|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908590|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908591|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908592|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908593|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908594|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908595|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908596|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908597|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908598|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908599|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908600|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908601|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908602|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908603|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908604|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908605|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908606|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908607|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908608|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908609|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908610|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908611|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908612|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908613|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908614|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908615|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908616|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908617|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908618|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Eligible participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908619|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908620|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908621|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908622|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908623|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908624|NCT01066819|O6|Outcome|Genotype Unknown (UNK)|Participants with serologically proven CHC (Genotype unknown) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908625|NCT01066819|O5|Outcome|Genotype 5/6 (G5/6)|Participants with serologically proven CHC (Genotype 5/6) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908626|NCT01066819|O4|Outcome|Genotype 4 (G4)|Eligible participants with serologically proven CHC (Genotype 4) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908627|NCT01066819|O3|Outcome|Genotype 3 (G3)|Eligible participants with serologically proven CHC (Genotype 3) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908628|NCT01066819|O2|Outcome|Genotype 2 (G2)|Eligible participants with serologically proven CHC (Genotype 2) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908629|NCT01066819|O1|Outcome|Genotype 1 (G1)|Eligible Participants with serologically proven CHC (Genotype 1) who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908630|NCT01066819|E1|Reported Event|Total (PEG-IFN Alfa-2a +PEG-IFN Alfa-2b)|Eligible participants with serologically proven CHC who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin for up to 48 weeks according to the standard of care and in line with SPCs/local labeling were observed.
908631|NCT01066793|B7|Baseline|Total|Total of all reporting groups
908632|NCT01066793|B6|Baseline|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908633|NCT01066793|B5|Baseline|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908814|NCT01066585|E1|Reported Event|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
921576|NCT01026220|E3|Reported Event|Group 3|Regimen II
908634|NCT01066793|B4|Baseline|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908635|NCT01066793|B3|Baseline|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908636|NCT01066793|B2|Baseline|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908637|NCT01066793|B1|Baseline|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908638|NCT01066793|P6|Participant Flow|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908639|NCT01066793|P5|Participant Flow|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908640|NCT01066793|P4|Participant Flow|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908641|NCT01066793|P3|Participant Flow|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908642|NCT01066793|P2|Participant Flow|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908643|NCT01066793|P1|Participant Flow|Genotype 1 (G1)|Eligible participants infected with hepatitis C virus (HCV) of Genotype 1 who received Pegasys® (Pegylated Interferon [PEG-IFN] alfa-2a) or PegIntron® (PEG-IFN alfa-2b) plus ribavirin dose according to the standard of care and in line with summary of product characteristics (SPCs)/local labeling for up to 72 weeks were observed.
908644|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908645|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908646|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908647|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908648|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908649|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908650|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908651|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908652|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908653|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908654|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908655|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908656|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908657|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908658|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908848|NCT01066156|E1|Reported Event|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
908659|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908660|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908661|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV inclusive of all Genotypes who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908662|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908663|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908664|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908665|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908666|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908667|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908668|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908669|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908670|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908671|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908672|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908673|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908674|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908675|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908676|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908677|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908678|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908679|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908680|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908681|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908682|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908683|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908684|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908929|NCT01065558|B1|Baseline|Ecopipam|
908685|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908686|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908687|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908688|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908689|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908690|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908691|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908692|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908693|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908694|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908695|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908696|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908697|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908698|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908699|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908700|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908701|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908702|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908703|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908704|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908705|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908706|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908707|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908708|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908709|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908710|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
909024|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908711|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908712|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908713|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908714|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908715|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908716|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908717|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908718|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908719|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908720|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908721|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908722|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908723|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908724|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908725|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908726|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908727|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908728|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908729|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908730|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908731|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908732|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908733|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908734|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908735|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908736|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
921577|NCT01026220|E2|Reported Event|Group 2|Regimen I
908737|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908738|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908739|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908740|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908741|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908742|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908743|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908744|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908745|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908746|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908747|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908748|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908749|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908750|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908751|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908752|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908753|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908754|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908755|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908756|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908757|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908758|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908759|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908760|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908761|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908762|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
921578|NCT01026220|E1|Reported Event|Group 1|All Patients
908763|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908764|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908765|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908766|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908767|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908768|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908769|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908770|NCT01066793|O6|Outcome|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908771|NCT01066793|O5|Outcome|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908772|NCT01066793|O4|Outcome|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908773|NCT01066793|O3|Outcome|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908774|NCT01066793|O2|Outcome|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908775|NCT01066793|O1|Outcome|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908776|NCT01066793|E6|Reported Event|Unknown Genotype (UNK)|Eligible participants infected with HCV of Genotype unknown who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908777|NCT01066793|E5|Reported Event|Genotype 5/6 (G5/6)|Eligible participants infected with HCV of Genotype 5/6 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908778|NCT01066793|E4|Reported Event|Genotype 4 (G4)|Eligible participants infected with HCV of Genotype 4 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908779|NCT01066793|E3|Reported Event|Genotype 3 (G3)|Eligible participants infected with HCV of Genotype 3 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908780|NCT01066793|E2|Reported Event|Genotype 2 (G2)|Eligible participants infected with HCV of Genotype 2 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908781|NCT01066793|E1|Reported Event|Genotype 1 (G1)|Eligible participants infected with HCV of Genotype 1 who received PEG-IFN alfa-2a or PEG-IFN alfa-2b plus ribavirin dose according to the standard of care and in line with SPCs/local labeling for up to 72 weeks were observed.
908782|NCT01066780|B1|Baseline|ClearVoice|
908783|NCT01066780|P2|Participant Flow|Group B: Received ClearVoice HIGH Followed by MEDIUM|Two week of chronic use of Clearvoice HIGH followed by two week of chronic use of ClearVoice MEDIUM.
908784|NCT01066780|P1|Participant Flow|Group A: Received ClearVoice MEDIUM Followed by HIGH|Two weeks of chronic use of ClearVoice MEDIUM followed by two week of chronic use of ClearVoice HIGH.
908785|NCT01066780|O1|Outcome|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
908786|NCT01066780|E1|Reported Event|Group 1|Primary efficacy analyses were based on data from the 46 subjects that completed the study.
908787|NCT01066624|B4|Baseline|Total|Total of all reporting groups
908788|NCT01066624|B3|Baseline|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
908789|NCT01066624|B2|Baseline|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
909025|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908790|NCT01066624|B1|Baseline|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
908791|NCT01066624|P3|Participant Flow|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
908792|NCT01066624|P2|Participant Flow|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
908820|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908793|NCT01066624|P1|Participant Flow|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
908794|NCT01066624|O3|Outcome|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
908795|NCT01066624|O2|Outcome|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
908796|NCT01066624|O1|Outcome|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
908797|NCT01066624|E3|Reported Event|Calcium Phosphate (Caphosol) Mouth Rinse|"Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study.~Calcium phosphate (Caphosol) Ca2+/PO43- mouth rinse: Patients randomized to this group will be instructed to rinse their mouths with Caphosol 4 times daily after admission and until end of study."
908798|NCT01066624|E2|Reported Event|Cryotherapy (Ice Chips)|Cryotherapy (ice chips): Patients randomized to this group, on day -2 and -1, will be instructed to place approximately 1 ounce of crushed ice in their mouths 15 minutes prior to the initiation of melphalan infusion. The ice will be allowed to melt and should be replenish as soon as it had completely melted. Patients will be instructed to continue this procedure during the melphalan infusion and for 90 minutes after the end of the infusion. After patients are done with the cryotherapy they will follow the standard of care for prevention and management of oral mucositis until the end of the study.
908799|NCT01066624|E1|Reported Event|0.9% Sodium Chloride Irrigation Solution|"Standard of care for prevention and management of oral mucositis (0.9% Sodium Chloride irrigation solution): Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study.~0.9% Sodium Chloride irrigation solution: Patients randomized to this group will be instructed to rinse their mouths twice, with 1 ounce (30 ml) of room temperature 0.9% NaCl (normal saline), 4 times daily after admission and until end of study"
908800|NCT01066585|B3|Baseline|Total|Total of all reporting groups
908801|NCT01066585|B2|Baseline|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908802|NCT01066585|B1|Baseline|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908803|NCT01066585|P2|Participant Flow|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908804|NCT01066585|P1|Participant Flow|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908805|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908806|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908807|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908808|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908809|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
908810|NCT01066585|O1|Outcome|0.5% Ivermectin|Participants underwent a single treatment with 0.5% ivermectin cream at home on Day 1.
908811|NCT01066585|O2|Outcome|Vehicle Control|Participants underwent a single treatment with vehicle control cream at home on Day 1.
909788|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
908815|NCT01066546|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908816|NCT01066546|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908817|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908818|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908819|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908857|NCT01066104|P1|Participant Flow|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908821|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908822|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908823|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908824|NCT01066546|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908825|NCT01066546|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
908826|NCT01066520|B4|Baseline|Total|Total of all reporting groups
908827|NCT01066520|B3|Baseline|Diclofenac Gel|Diclofenac Gel 2g, 3 times daily topical during 14 days
908828|NCT01066520|B2|Baseline|Traumeel S Gel|Traumeel S Gel 2g, 3 times daily topical during 14 days
908829|NCT01066520|B1|Baseline|Traumeel S Ointment|Traumeel S Ointment 2g, 3 times daily topical during 14 days
908830|NCT01066520|P3|Participant Flow|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908831|NCT01066520|P2|Participant Flow|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908832|NCT01066520|P1|Participant Flow|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908833|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908834|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908835|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908836|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908837|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908838|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908839|NCT01066520|O3|Outcome|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908840|NCT01066520|O2|Outcome|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908841|NCT01066520|O1|Outcome|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908842|NCT01066520|E3|Reported Event|Diclofenac Gel|NSAID gel (Diclofenac 1%; standard brand), 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908843|NCT01066520|E2|Reported Event|Traumeel S Gel|Traumeel® S gel, 2 g of gel three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908844|NCT01066520|E1|Reported Event|Traumeel S Ointment|Traumeel® S ointment, 2 g of ointment three times daily for 14 days, to sufficiently cover the area of the lesion, gently rubbing
908845|NCT01066156|B1|Baseline|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
908846|NCT01066156|P1|Participant Flow|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
908847|NCT01066156|O1|Outcome|Seroquel|"This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD~Seroquel: This study will investigate therapeutic responses to Seroquel pharmacotherapy in PTSD"
909134|NCT01065051|E1|Reported Event|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
908849|NCT01066143|B1|Baseline|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
908850|NCT01066143|P1|Participant Flow|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
908851|NCT01066143|O1|Outcome|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
908852|NCT01066143|E1|Reported Event|Seroquel XR|Seroquel XR: Seroquel XR tablets will be flexibly dosed and begun at a target dose of 50 mg on day 1, 100 mg on day 2, 150 mg on day 3 and 200 mg on day 4 with a maximal daily dose of 400 mg on subsequent days.
908853|NCT01066104|B3|Baseline|Total|Total of all reporting groups
908854|NCT01066104|B2|Baseline|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908855|NCT01066104|B1|Baseline|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908856|NCT01066104|P2|Participant Flow|Xolair (Omalizumab)|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
917372|NCT01037218|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
908861|NCT01066104|O1|Outcome|Xolair Placebo|Xolair: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908862|NCT01066104|E2|Reported Event|Xolair (Omalizumab)|Xolair (omalizumab): two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908863|NCT01066104|E1|Reported Event|Xolair Placebo|Xolair placebo: two to four weeks (dosage and frequency will be determined based on patient weight and IgE level)
908864|NCT01066039|B1|Baseline|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908865|NCT01066039|P1|Participant Flow|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 milligram (mg) once daily for 24 weeks. If the blood pressure was not less than 130/80 millimeter of mercury (mmHg) during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908866|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908867|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908868|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908869|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908870|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908871|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908872|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908873|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908874|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908875|NCT01066039|O1|Outcome|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908876|NCT01066039|E1|Reported Event|Bisoprolol|Bisoprolol tablet was administered orally at dose of 5 mg once daily for 24 weeks. If the blood pressure was not less than 130/80 mmHg during the first 8 weeks of treatment (up-titration), then the dose was adjusted to 10 mg daily. In cases of hypotensive effect, symptomatic bradycardia or arrhythmia, the daily dose was reduced to 2.5 mg.
908877|NCT01066000|B1|Baseline|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908878|NCT01066000|P1|Participant Flow|Mircera|Eligible participants received methoxy polyethylene glycol-epoetin beta (Mircera) intravenously (IV), once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 microgram (mcg) which was based on the Epoetin dose of<8000, 8000-16000, or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
908879|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908880|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908881|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908911|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908882|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908883|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908884|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908885|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908886|NCT01066000|O1|Outcome|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908887|NCT01066000|E1|Reported Event|Mircera|Eligible participants received Mircera IV, once every four weeks for 24 weeks. Participants received a starting dose of Mircera 100, 150 or 200 mcg which was based on the Epoetin dose of <8000, 8000-16000, or >16000 IU/Week, administered during the week preceding the switch to the study drug.
908888|NCT01065844|B1|Baseline|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
908889|NCT01065844|P1|Participant Flow|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
908890|NCT01065844|O1|Outcome|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
908891|NCT01065844|E1|Reported Event|Nelfinavir|"1250 mg Nelfinavir twice daily Monday-Sunday~Nelfinavir: 1250 mg Nelfinavir twice daily Monday - Sunday"
908892|NCT01065779|B1|Baseline|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908893|NCT01065779|P1|Participant Flow|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908894|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908895|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908896|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908897|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908898|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908899|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908900|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
909789|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
908901|NCT01065779|O1|Outcome|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908902|NCT01065779|E1|Reported Event|FOSAMAX PLUS/ FOSAMAX PLUS D|Participants with Osteoporosis treated with FOSAMAX PLUS or FOSAMAX PLUS D. One 70 mg alendronate/2800 International Units (IU) Vitamin D tablet or one 70 mg alendronate/5600 IU Vitamin D tablet taken once weekly.
908903|NCT01065766|B1|Baseline|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908904|NCT01065766|P1|Participant Flow|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908905|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908906|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908907|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908908|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908909|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908910|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908988|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908912|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908913|NCT01065766|O1|Outcome|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908914|NCT01065766|E1|Reported Event|All Participants Included in the Safety Evaluation|Korean participants with type 2 diabetes mellitus treated with sitagliptin/metformin
908915|NCT01065714|B1|Baseline|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
908916|NCT01065714|P1|Participant Flow|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment. Eucerin Lotion applied to one side of body, Hydrogel applied to the opposite side of body.
908917|NCT01065714|O1|Outcome|Skin Hydration With Hydrogel|Parallel designed study. Split body treatment. Hydrogel vehicle applied to targeted area one side of body. Skin Hydration measured by 5 Corneometer readings.
908918|NCT01065714|O1|Outcome|Skin Hydration With Eucerin|Parallel designed study. Split body treatment. Five corneometer readings were taken on the targeted area of one half of the body on which Eucerin Lotion was applied.
908919|NCT01065714|O1|Outcome|Skin Barrier Function With Hydrogel Vehicle|Trans epidural water loss measurements on target areas of body side treated with Hydrogel vehicle
908920|NCT01065714|O1|Outcome|Skin Barrier Function With Eucerin Lotion|Measurement of TEWL on targeted area on one side of body treated with Eucerin Lotion
908921|NCT01065714|E1|Reported Event|Hydrogel Vehicle/Eucerin Lotion|Parallel designed study. Split body treatment
908922|NCT01065597|B1|Baseline|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
908923|NCT01065597|P1|Participant Flow|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
908924|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
908925|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
908926|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
908927|NCT01065597|O1|Outcome|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
908928|NCT01065597|E1|Reported Event|Nonconvulsive Electrotherapy|"Open label single arm study of nonconvulsive electrotherapy~Nonconvulsive electrotherapy: An electrical stimulus will be given as in electroconvulsive therapy (ECT)using bifrontal electrode placement and a Thymatron System IV device; however, the device will be set at a lower energy level that is 12.5%(1/8) of the expected energy needed to induce a seizure rather than at an energy level that is at or above the seizure threshold."
908930|NCT01065558|P1|Participant Flow|Ecopipam (12.5- 200 mg/Day)|"Patients were given ecopipapm over an 11 day period as follows:~day 1 12.5 mg/day day 2-3 25 mg/day day 4-5 50 mg/day day 6-9 100 mg/day day 9-11 200 mg/day~Note: Doses were reduced as necessary to a previously tolerated dose if paitents reached doses that were not safely tolerable."
908931|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
908932|NCT01065558|O1|Outcome|Ecopipam Treated Patients|These were patients who had diagnoses Lesch-Nyhan Disease based either on their genetic changes or on changes of specific enzymes in their blood.
908933|NCT01065558|E1|Reported Event|Ecopipam Treated Patients|
908934|NCT01065506|B3|Baseline|Total|Total of all reporting groups
908935|NCT01065506|B2|Baseline|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
908936|NCT01065506|B1|Baseline|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
908937|NCT01065506|P2|Participant Flow|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise thrice weekly (on a treadmill)"
908938|NCT01065506|P1|Participant Flow|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program consisting of thrice weekly sessions involving discussion of various wellness topics (e.g., diet, sun care, cancer prevention) and generating small wellness-related goals"
908939|NCT01065506|O2|Outcome|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
908940|NCT01065506|O1|Outcome|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
908941|NCT01065506|E2|Reported Event|Standard Care Plus Exercise Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Aerobic Exercise: Aerobic Exercise"
908942|NCT01065506|E1|Reported Event|Standard Care Plus Wellness Program|"Cognitive Behavioral Treatment: Cognitive Behavioral Treatment~Nicotine Patch: Nicotine Patch~Wellness Program: Wellness Program"
908943|NCT01065454|B5|Baseline|Total|Total of all reporting groups
908944|NCT01065454|B4|Baseline|Placebo|Participants received placebo tid.
908945|NCT01065454|B3|Baseline|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908946|NCT01065454|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908947|NCT01065454|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908948|NCT01065454|P4|Participant Flow|Placebo|Participants received placebo tid.
908949|NCT01065454|P3|Participant Flow|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908950|NCT01065454|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908951|NCT01065454|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908952|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908953|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908954|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908955|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908956|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908957|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908958|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908959|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908960|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908961|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908962|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908963|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908964|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908965|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908966|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908967|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908968|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908969|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908970|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908971|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908972|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908973|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
910360|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
908974|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908975|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908976|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908977|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908978|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908979|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908980|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908981|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908982|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908983|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908984|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908985|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908986|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908987|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908989|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908990|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908991|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908992|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908993|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908994|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908995|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
908996|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
908997|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
908998|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
908999|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909000|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909001|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909002|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909003|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909004|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909005|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909006|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909007|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909008|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909009|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909010|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909011|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909012|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909013|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909014|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909015|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909016|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909017|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909018|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909019|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909020|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909021|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909022|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909023|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909026|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909027|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909028|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909029|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909030|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909031|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909032|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909033|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909034|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909035|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909036|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909037|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909038|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909039|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909040|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909041|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909042|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909043|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909044|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909045|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909046|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909047|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909048|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909049|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909050|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909051|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909052|NCT01065454|O4|Outcome|Placebo|Participants received placebo tid.
909053|NCT01065454|O3|Outcome|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose).
909054|NCT01065454|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg).
909055|NCT01065454|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909056|NCT01065454|E4|Reported Event|Placebo|Participants received placebo tid
909057|NCT01065454|E3|Reported Event|Riociguat (Adempas, BAY63-2521) Fixed 0.5 mg|Participants received riociguat 0.5 mg tid (fixed dose)
909058|NCT01065454|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1 mg|Participants received riociguat up to 1 mg tid (increasing from 0.5 to 1 mg)
909059|NCT01065454|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2 mg|Participants received riociguat up to 2 mg three times per day (tid) (increasing from 0.5 to 1 to 2 mg).
909060|NCT01065428|B3|Baseline|Total|Total of all reporting groups
909061|NCT01065428|B2|Baseline|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
909062|NCT01065428|B1|Baseline|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
909063|NCT01065428|P2|Participant Flow|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
909064|NCT01065428|P1|Participant Flow|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
909065|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
909066|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
909067|NCT01065428|O2|Outcome|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
909068|NCT01065428|O1|Outcome|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
909069|NCT01065428|E2|Reported Event|Weaning Successful|Weaning successful:extubation and the absence of ventilatory support 48 h following the extubation
909070|NCT01065428|E1|Reported Event|Weaning Failure|Weaning failure:(1) failed spontaneous breathing trials (SBT); (2) reintubation and /or resumption of support following successful extubation; or (3) die 48h following extubation.
909071|NCT01065350|B3|Baseline|Total|Total of all reporting groups
909612|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
909072|NCT01065350|B2|Baseline|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose. One subject in the ketofol group was excluded from analysis due to incorrect study drug assignment and outside the protocol-specified dose."
909073|NCT01065350|B1|Baseline|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909074|NCT01065350|P2|Participant Flow|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909075|NCT01065350|P1|Participant Flow|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909076|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909077|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909626|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
909078|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909079|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909080|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909081|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909082|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909083|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909084|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909085|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909086|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909087|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909088|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909089|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909090|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909091|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909092|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909093|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909182|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909094|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909095|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909096|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909097|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909098|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909099|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909192|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909100|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909101|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909102|NCT01065350|O2|Outcome|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909103|NCT01065350|O1|Outcome|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909104|NCT01065350|E2|Reported Event|Ketofol|"As part of the induction, patients will be given 20 mL syringe of an admixture called ketofol, which combines ketamine and propofol in one syringe. The dose is weight-based such that ketamine will represent 0.75 mg/kg of the dose and propofol, 1.5 mg/kg of the dose."
909105|NCT01065350|E1|Reported Event|Propofol|As part of the induction, patients will be given 2 milligrams of propofol per kilogram (mg/kg) of body weight. The clinician will receive a 20 milliliter (mL) syringe of propofol. If the dose, 2 mg/kg, does not add up to a total of 20 mL, normal saline will be added to make up for the 20 mL.
909106|NCT01065051|B3|Baseline|Total|Total of all reporting groups
909107|NCT01065051|B2|Baseline|Placebo|Participants received a single oral dose of 1 mg placebo.
909108|NCT01065051|B1|Baseline|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909109|NCT01065051|P2|Participant Flow|Placebo|Participants received a single oral dose of 1 mg placebo.
909110|NCT01065051|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909111|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909112|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909113|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909114|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909115|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909116|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909117|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909118|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909119|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909120|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909121|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909122|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909123|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909124|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909125|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909126|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909127|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909128|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909129|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909130|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909131|NCT01065051|O2|Outcome|Placebo|Participants received a single oral dose of 1 mg placebo.
909132|NCT01065051|O1|Outcome|Riociguat (Adempas, BAY63-2521)|Participants received a single oral dose of 1 mg riociguat.
909133|NCT01065051|E2|Reported Event|Placebo|Participants received a single oral dose of 1 mg placebo.
909654|NCT01064167|B3|Baseline|Total|Total of all reporting groups
909135|NCT01064947|B1|Baseline|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
909136|NCT01064947|P1|Participant Flow|All Participants|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
909137|NCT01064947|O1|Outcome|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
909138|NCT01064947|O1|Outcome|Participants With a Positive Culture at Day 1|
909139|NCT01064947|O1|Outcome|Participants With Positive Culture at Day 1|
909140|NCT01064947|O2|Outcome|Participants With a Positive Culture at Day 1|
909141|NCT01064947|O1|Outcome|All Participants at Day 1|All consented subjects with an apparent secondary infection were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if necessary) for 7 days. The subject treatment site was cultured after 7 days of treatment.
909193|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909194|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909142|NCT01064947|E1|Reported Event|All Participants|All consented subjects with a suspected secondary infection of atopic dermatitis were cultured.The treatment of Retapamulin 1% was started , with a thin layer applied twice daily and covered with gauze (if desired) for 7 days. The subject treatment site was cultured after 7 days of treatment.
909143|NCT01064882|B4|Baseline|Total|Total of all reporting groups
909144|NCT01064882|B3|Baseline|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909145|NCT01064882|B2|Baseline|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909146|NCT01064882|B1|Baseline|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909147|NCT01064882|P3|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909148|NCT01064882|P2|Participant Flow|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909149|NCT01064882|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909150|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909151|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909152|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909153|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909154|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909155|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909156|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909157|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909158|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909159|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909160|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909161|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909162|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909163|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909164|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909165|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909166|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909167|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909168|NCT01064882|O3|Outcome|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909169|NCT01064882|O2|Outcome|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909170|NCT01064882|O1|Outcome|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909171|NCT01064882|E3|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|bimatoprost ophthalmic solution 0.03%
909172|NCT01064882|E2|Reported Event|Bimatoprost Ophthalmic Solution 0.015%|bimatoprost ophthalmic sterile solution 0.015%
909173|NCT01064882|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.005%|bimatoprost ophthalmic sterile solution 0.005%
909174|NCT01064856|B3|Baseline|Total|Total of all reporting groups
909175|NCT01064856|B2|Baseline|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909176|NCT01064856|B1|Baseline|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909177|NCT01064856|P4|Participant Flow|Double-blind Placebo / Open-label Adalimumab|Placebo SC injection every other week (eow) up to Week 12 in the double-blind period; adalimumab 40 mg subcutaneous injection eow from Week 12 to Week 156 in the open-label period.
909178|NCT01064856|P3|Participant Flow|Double-blind Adalimumab / Open-label Adalimumab|Adalimumab 40 mg SC injection eow up to Week 12 in double-blind period and from Week 12 to Week 156 in open-label period.
909179|NCT01064856|P2|Participant Flow|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909180|NCT01064856|P1|Participant Flow|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909181|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909183|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909184|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909185|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909186|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909187|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909188|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909189|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909190|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909191|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909665|NCT01064076|B1|Baseline|S-ICD System|This is a single arm study
909195|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909196|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909197|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909198|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909199|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909200|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909201|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909202|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909203|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909204|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909205|NCT01064856|O2|Outcome|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909206|NCT01064856|O1|Outcome|Double-blind (DB) Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909207|NCT01064856|E3|Reported Event|Any Adalimumab|All randomized participants who had received at least 1 dose of adalimumab (blinded or open-label) at any time during the study (up to Week 156).
909208|NCT01064856|E2|Reported Event|Double-blind Adalimumab|Adalimumab 40 mg subcutaneous (SC) injection every other week (eow) up to Week 12 in double-blind period.
909209|NCT01064856|E1|Reported Event|Double-blind Placebo|Placebo subcutaneous (SC) injection every other week (eow) up to Week 12 in the double-blind period.
909210|NCT01064830|B3|Baseline|Total|Total of all reporting groups
909211|NCT01064830|B2|Baseline|Vehicle|apply to affected nails at night
909212|NCT01064830|B1|Baseline|Cyclosporine Solution|apply to affected nails at night
909213|NCT01064830|P2|Participant Flow|Vehicle (Refresh Dry Eye Therapy®)|Topical vehicle: Refresh Dry Eye Therapy® (ophthalmic solution of glycerin 1% and polysorbate 80 1%)
909214|NCT01064830|P1|Participant Flow|Cyclosporine Solution 0.05% (Restasis®)|Topical Cyclosporine 0.05% Ophthalmic Suspension
909215|NCT01064830|O2|Outcome|Vehicle|vehicle
909216|NCT01064830|O1|Outcome|Cyclosporine Solution|cyclosporine solution
909217|NCT01064830|O2|Outcome|Vehicle|topical
909218|NCT01064830|O1|Outcome|Cyclosporine Solution|topical
909219|NCT01064830|E2|Reported Event|Vehicle|topical
909220|NCT01064830|E1|Reported Event|Cyclosporine Solution|topical
909221|NCT01064817|B3|Baseline|Total|Total of all reporting groups
909222|NCT01064817|B2|Baseline|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909223|NCT01064817|B1|Baseline|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909224|NCT01064817|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909225|NCT01064817|P1|Participant Flow|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909226|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909227|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909228|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909229|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909230|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909231|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909232|NCT01064817|O2|Outcome|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909233|NCT01064817|O1|Outcome|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909234|NCT01064817|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo solution (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909235|NCT01064817|E1|Reported Event|PRM-151|"PRM-151 (recombinant human serum amyloid P, recombinant human pentraxin 2)~PRM-151: PRM-151 2 milligrams (mg) (0.1 mL volume) by subconjunctival injection Days 1 (immediately following trabeculectomy), 2, 3, 5 and 9"
909236|NCT01064739|B1|Baseline|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909237|NCT01064739|P1|Participant Flow|Fixed Sodium Diet +/- Fava Beans|Participants consumed a fixed sodium diet on day 1 and the same diet plus 100g of fresh fava beans at breakfast and lunch on day 2.The 14 participants received both interventions.
909238|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909239|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909240|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909241|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909242|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
909243|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909244|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909245|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909246|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909247|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909248|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909249|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909250|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
909251|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909252|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909253|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909254|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
909255|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909369|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909256|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909257|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909258|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909259|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909260|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909261|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909262|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909263|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909264|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909265|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909266|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909267|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909309|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909268|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909269|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909270|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909271|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909541|NCT01064362|B2|Baseline|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
909272|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909273|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909274|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909275|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909276|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909277|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909278|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909279|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909280|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909281|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909282|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909283|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909284|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909285|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909286|NCT01064739|O2|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909287|NCT01064739|O1|Outcome|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909288|NCT01064739|O2|Outcome|Fixed Sodium Study Diet|A study diet with a fixed amount of sodium and no fava beans.
909341|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909289|NCT01064739|O1|Outcome|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909290|NCT01064739|E2|Reported Event|Fixed Sodium Study Diet|Participants underwent testing while on a methylxanthine-free diet providing 150 mEq sodium and 75 mEq potassium per day. The study involved a longitudinal design where the participants served as their own controls. Subjects consumed the standard fixed sodium diet on study day one. On study day two, participants ate 100 g of puréed fava beans and pods with study diet at breakfast (0800hr) and lunch (1200hr).
909291|NCT01064739|E1|Reported Event|Fava Beans|"A meal enriched in dopa content, using fava beans, will be eaten at 0800hr (breakfast) and 1200hr (lunch), with measurements following the same schedule as the day with just fixed sodium study diet.~Fava beans : Participants will receive 100g of fresh fava beans for breakfast and lunch on one study day and prior to this study day will be restricted to a fixed sodium low monoamine diet"
909292|NCT01064687|B5|Baseline|Total|Total of all reporting groups
909293|NCT01064687|B4|Baseline|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909294|NCT01064687|B3|Baseline|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909295|NCT01064687|B2|Baseline|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909296|NCT01064687|B1|Baseline|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909297|NCT01064687|P4|Participant Flow|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909298|NCT01064687|P3|Participant Flow|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909299|NCT01064687|P2|Participant Flow|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909300|NCT01064687|P1|Participant Flow|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909301|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909302|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909303|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909304|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909305|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909306|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909307|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909308|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909310|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909311|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909312|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909313|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909314|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909342|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909315|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909316|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909317|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909318|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909319|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909320|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909321|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909322|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909323|NCT01064687|O3|Outcome|Placebo/0.75 mg LY2189265 or 1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909324|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909325|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909326|NCT01064687|O3|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909327|NCT01064687|O2|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909328|NCT01064687|O1|Outcome|0.75 mg LY2189265 or 1.5 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 or 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909329|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909330|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909331|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909332|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909333|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909334|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909335|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909336|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
921579|NCT01026194|B3|Baseline|Total|Total of all reporting groups
909337|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909338|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909339|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909340|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909542|NCT01064362|B1|Baseline|Fondaparinux|All dosages of fondaparinux
909343|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909344|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909345|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909346|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909347|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909348|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909349|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909350|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909351|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909352|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909353|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909354|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909355|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909356|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909357|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909358|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909359|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909360|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909361|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909362|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909363|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
910361|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
909364|NCT01064687|O5|Outcome|Placebo/0.75 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909365|NCT01064687|O4|Outcome|Placebo/1.5 mg LY2189265|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909366|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909367|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909368|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909666|NCT01064076|P1|Participant Flow|S-ICD System|This is a single arm study
909370|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909371|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909372|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909373|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909374|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909375|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909376|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909377|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909378|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909379|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909380|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909381|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909382|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909383|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909384|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909385|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909386|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909387|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909388|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909389|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909390|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909391|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909392|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909393|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909394|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909395|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909396|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909397|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909398|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909399|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909400|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909401|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909402|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909403|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909404|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909405|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909406|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909407|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909408|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909409|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909410|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909411|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909412|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909413|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909414|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909415|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909416|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909417|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909418|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909419|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909420|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909421|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909422|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909423|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909667|NCT01064076|O1|Outcome|S-ICD System|This is a single arm study
909424|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909425|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909426|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909427|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909428|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909429|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909430|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909431|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909432|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909433|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909434|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909435|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909436|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909437|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909438|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909439|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909440|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909441|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909442|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909443|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909444|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
922353|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
909445|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909446|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909447|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909448|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909449|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909450|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909451|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909452|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909453|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909454|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909455|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909456|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909457|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909458|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909459|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909460|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909461|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909462|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909463|NCT01064687|O4|Outcome|Placebo|"Placebo: subcutaneous (SC), once weekly for 26 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 26 weeks~Pioglitazone: at least 30 mg/day, oral, for 26 weeks"
909464|NCT01064687|O3|Outcome|Exenatide|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909465|NCT01064687|O2|Outcome|0.75 mg LY2189265|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909466|NCT01064687|O1|Outcome|1.5 mg LY2189265|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909467|NCT01064687|E9|Reported Event|Placebo/1.5 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 1.5 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
909468|NCT01064687|E8|Reported Event|Placebo/0.75 mg LY2189265 (26 Weeks Through 56 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): 0.75 milligrams (mg), SC, once weekly from week 26 through week 52~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks~All events were treatment emergent during the LY2189265 treatment period."
909469|NCT01064687|E7|Reported Event|Exenatide (Baseline Through 56 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909470|NCT01064687|E6|Reported Event|1.5 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909471|NCT01064687|E5|Reported Event|0.75 mg LY2189265 (Baseline Through 56 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909472|NCT01064687|E4|Reported Event|Placebo (Baseline Through 26 Weeks)|"Placebo: subcutaneous (SC), once weekly for 26 weeks~LY2189265 (Dulaglutide): After 26 weeks, participants were randomized to receive either 0.75 milligrams (mg) or 1.5 mg, SC, once weekly for an additional 26 weeks (from week 26 through week 52)~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909473|NCT01064687|E3|Reported Event|Exenatide (Baseline Through 26 Weeks)|"Exenatide: 5 micrograms (mcg), subcutaneous (SC), twice daily for 4 weeks, followed by 10 mcg, SC, twice daily for 48 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909474|NCT01064687|E2|Reported Event|1.5 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 1.5 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909497|NCT01064622|E4|Reported Event|Phase II Crossover Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
909475|NCT01064687|E1|Reported Event|0.75 mg LY2189265 (Baseline Through 26 Weeks)|"LY2189265 (Dulaglutide): 0.75 milligrams (mg), subcutaneous (SC), once weekly for 52 weeks~Metformin: at least 1500 milligrams per day (mg/day), oral, for 52 weeks~Pioglitazone: at least 30 mg/day, oral, for 52 weeks"
909476|NCT01064622|B4|Baseline|Total|Total of all reporting groups
909477|NCT01064622|B3|Baseline|Phase I lead-in Patients|Patients enrolled in the lead-in phase I portion of the trial. Patients receive 1000 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and 150 mg vismodegib PO QD on days 1-28.
909478|NCT01064622|B2|Baseline|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909479|NCT01064622|B1|Baseline|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909480|NCT01064622|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909481|NCT01064622|P1|Participant Flow|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909482|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
909483|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909484|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909485|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
909486|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909487|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909488|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
909489|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909490|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909491|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
909492|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909530|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
909531|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
909493|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909494|NCT01064622|O3|Outcome|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
909495|NCT01064622|O2|Outcome|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909496|NCT01064622|O1|Outcome|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909498|NCT01064622|E3|Reported Event|Phase I lead-in Patients|Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28.
909499|NCT01064622|E2|Reported Event|Arm II (Gemcitabine Hydrochloride and Vismodegib)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~gemcitabine hydrochloride: Given IV"
909500|NCT01064622|E1|Reported Event|Arm I (Gemcitabine Hydrochloride and Placebo)|"Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.~gemcitabine hydrochloride: Given IV~hydrocortisone/placebo: Given PO"
909501|NCT01064414|B4|Baseline|Total|Total of all reporting groups
909502|NCT01064414|B3|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.
909503|NCT01064414|B2|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks.
909504|NCT01064414|B1|Baseline|Placebo|Each patient received matching placebo once daily for 52 weeks.
909505|NCT01064414|P3|Participant Flow|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin once daily for 52 weeks.Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
909506|NCT01064414|P2|Participant Flow|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
909507|NCT01064414|P1|Participant Flow|Placebo|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26 (Core Period) and for Week 26 to 52 (Extension Period).
909508|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
909509|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
909510|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
909511|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
909512|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
909513|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
909514|NCT01064414|O3|Outcome|Canagliflozin 300 mg|Each patient received canagliflozin 300 mg once daily for 52 weeks.
909515|NCT01064414|O2|Outcome|Canagliflozin 100 mg|Each patient received canagliflozin 100 mg once daily for 52 weeks.
909516|NCT01064414|O1|Outcome|Placebo|Each patient received matching placebo once daily for 52 weeks.
909517|NCT01064414|E6|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
909518|NCT01064414|E5|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 52.
909519|NCT01064414|E4|Reported Event|Placebo: Baseline to Week 52|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 52.
909520|NCT01064414|E3|Reported Event|Canagliflozin 300 mg: Baseline to Week 26|Each patient received 300 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
909521|NCT01064414|E2|Reported Event|Canagliflozin 100 mg: Baseline to Week 26|Each patient received 100 mg of canagliflozin once daily for 52 weeks. Data are presented for Baseline to Week 26.
909522|NCT01064414|E1|Reported Event|Placebo: Baseline to Week 26|Each patient received matching placebo once daily for 52 weeks. Data are presented for Baseline to Week 26.
909523|NCT01064401|B3|Baseline|Total|Total of all reporting groups
909524|NCT01064401|B2|Baseline|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
909525|NCT01064401|B1|Baseline|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
909526|NCT01064401|P2|Participant Flow|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a intramuscular IM injection once weekly for 96 to 144 weeks
909527|NCT01064401|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (IFN β-1a) 30 µg intramuscular (IM) injection once weekly plus placebo to daclizumab high yield process (DAC HYP) subcutaneous (SC) once every 4 weeks for 96 to 144 weeks
909528|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
909529|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
909532|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
909533|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
909534|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg SC injection once every 4 weeks plus placebo to IFN β-1a IM injection once weekly for 96 to 144 weeks
909535|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
909536|NCT01064401|O2|Outcome|Daclizumab High Yield Process|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
909537|NCT01064401|O1|Outcome|Interferon Beta-1a|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
909538|NCT01064401|E2|Reported Event|DAC HYP 150 mg|DAC HYP 150 mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
909539|NCT01064401|E1|Reported Event|IFN Beta-1a 30 mcg|IFN β-1a 30 µg IM injection once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
909540|NCT01064362|B3|Baseline|Total|Total of all reporting groups
909543|NCT01064362|P2|Participant Flow|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
909544|NCT01064362|P1|Participant Flow|Fondaparinux|All dosages of fondaparinux
909545|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
909546|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
909547|NCT01064362|O2|Outcome|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
909548|NCT01064362|O1|Outcome|Fondaparinux|All dosages of fondaparinux
909549|NCT01064362|E2|Reported Event|Low Molecular Weight Heparins (LMWHs)|All dosages of LMWH, including Enoxaparin, Dalteparin, Nadroparin, and Tinzaparin
909550|NCT01064362|E1|Reported Event|Fondaparinux|All dosages of fondaparinux
909551|NCT01064310|B3|Baseline|Total|Total of all reporting groups
909552|NCT01064310|B2|Baseline|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909553|NCT01064310|B1|Baseline|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909554|NCT01064310|P3|Participant Flow|Open Label Pazopinib|To provide continued access to treatment
909555|NCT01064310|P2|Participant Flow|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909556|NCT01064310|P1|Participant Flow|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909557|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909558|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909605|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
909606|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
923454|NCT01019928|O1|Outcome|AZD1386 95 mg|
909559|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909560|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909561|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909618|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
909619|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
909620|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
917373|NCT01037218|E4|Reported Event|Placebo|Placebo tablets
909562|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909563|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909564|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909565|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909566|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909567|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909568|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909569|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909570|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909571|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909572|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909607|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
909573|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909621|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
909622|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
909623|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
909624|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
909625|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
909574|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909575|NCT01064310|O2|Outcome|Pazopanib|Participants received 4 overencapsulated tablets of pazopanib (either in Period 1 or Period 2), each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909576|NCT01064310|O1|Outcome|Sunitinib|Participants received 4 overencapsulated capsules of sunitinib (either in Period 1 or Period 2), each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drug was taken orally OD without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drug was taken remained relatively constant.
909577|NCT01064310|O2|Outcome|Pazopanib 800 mg Followed by Sunitinib 50 mg|Period 1: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period2: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 mg of sunitinib, OD orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909578|NCT01064310|O1|Outcome|Sunitinib 50 mg Followed by Pazopanib 800 mg|Period 1: Participants received 4 overencapsulated capsules of sunitinib, each containing 12.5 milligrams (mg) of sunitinib, once daily (OD) orally for 4 weeks, followed by 2 weeks off treatment (matching placebo capsules to maintain blind), followed by 50 mg (4 x 12.5 mg) OD orally for 4 weeks. Period 1 was followed by a 2-week wash-out period in which no treatment was given. Period 2: Participants received 4 overencapsulated tablets of pazopanib, each containing 200 mg of pazopanib, OD orally for 10 weeks. Study drugs were taken without food at least one hour before or two hours after a meal. The capsules were swallowed whole and not crushed or broken. The time of day the study drugs were taken remained relatively constant.
909579|NCT01064310|E3|Reported Event|Open Label Pazopanib|Open Label Pazopanib
909580|NCT01064310|E2|Reported Event|Pazopanib|Pazopanib
909581|NCT01064310|E1|Reported Event|Sunitinib|Sunitinib
909582|NCT01064297|B4|Baseline|Total|Total of all reporting groups
909583|NCT01064297|B3|Baseline|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
909584|NCT01064297|B2|Baseline|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
909585|NCT01064297|B1|Baseline|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
909586|NCT01064297|P3|Participant Flow|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate, all dose ranges
909587|NCT01064297|P2|Participant Flow|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate, all dose ranges
909588|NCT01064297|P1|Participant Flow|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy at doses between 0-1200 mg/day
909589|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
909590|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
909591|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
909592|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
909593|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
909594|NCT01064297|O3|Outcome|Doses Higher Than Prescribed|>400 mg/day maximal dose in first trimester
909595|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
909596|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
909597|NCT01064297|O4|Outcome|Unknown Maximal Dose in Exposed Trimester|
909598|NCT01064297|O3|Outcome|Dose Higher Than Prescribed|>400 mg/day maximal dose in first trimester
909599|NCT01064297|O2|Outcome|Prescribed Doses|201-400 mg/day maximal dose in first trimester
909600|NCT01064297|O1|Outcome|Doses Lower Than Prescribed|>0 to 200 mg/day maximal dose in first trimester
909601|NCT01064297|O5|Outcome|All Trimesters|Exposure during any trimester of pregnancy
909602|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
909603|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
909604|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
923455|NCT01019928|O2|Outcome|Placebo|
909613|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
909614|NCT01064297|O2|Outcome|First Exposure During Second Trimester|The second trimester begins at 14 weeks gestation
909615|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
909616|NCT01064297|O4|Outcome|Unspecified Trimester of Exposure|The earliest trimester of exposure was not specified
909617|NCT01064297|O3|Outcome|First Exposure During Third Trimester|The third trimester begins at 28 weeks gestation
909627|NCT01064297|O1|Outcome|First Exposure During First Trimester|The first trimester begins at conception
909628|NCT01064297|E3|Reported Event|Lamotrigine Polytherapy Without Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy without valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
909629|NCT01064297|E2|Reported Event|Lamotrigine Polytherapy With Valproate Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine polytherapy with valproate exposures with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
909630|NCT01064297|E1|Reported Event|Lamotrigine Monotherapy Pregnancy Exposures|Prospectively enrolled pregnancies exposed to lamotrigine monotherapy with completed pregnancy outcome (does not include those lost to follow up where outcome information could not be obtained)
909631|NCT01064284|B3|Baseline|Total|Total of all reporting groups
909632|NCT01064284|B2|Baseline|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909633|NCT01064284|B1|Baseline|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909634|NCT01064284|P2|Participant Flow|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909635|NCT01064284|P1|Participant Flow|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909636|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909637|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909638|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909639|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909640|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909641|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909642|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909643|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909644|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909645|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909646|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909647|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909648|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909649|NCT01064284|O1|Outcome|PLASMA DERIVED Factor VIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909650|NCT01064284|O2|Outcome|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909651|NCT01064284|O1|Outcome|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909652|NCT01064284|E2|Reported Event|rFVIII|"Recombinant FVIII~Recombinant FVIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909653|NCT01064284|E1|Reported Event|pd vWF/FVIII|"Plasma-derived vWF/FVIII~PLASMA DERIVED Factor VIII: Maximum dosage : 50IU per kilo. 2-3 times per week or on demand during acute episode of bleeding"
909655|NCT01064167|B2|Baseline|Control Group|The placebo consisted of an equivalent volume of saline solution.
909656|NCT01064167|B1|Baseline|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
909657|NCT01064167|P2|Participant Flow|Control Group|The placebo consisted of an equivalent volume of saline solution.
909658|NCT01064167|P1|Participant Flow|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
909659|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
909660|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
909661|NCT01064167|O2|Outcome|Control Group|The placebo consisted of an equivalent volume of saline solution.
909662|NCT01064167|O1|Outcome|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
909663|NCT01064167|E2|Reported Event|Control Group|The placebo consisted of an equivalent volume of saline solution.
909664|NCT01064167|E1|Reported Event|Tranexamic Acid Group|Tranexamic acid 1g was administered as a bolus injection 20 minutes before the incision and followed by a continuous infusion of 400 mg/h until the completion of the surgery.
909668|NCT01064076|O1|Outcome|Single Arm|Cohort includes all subjects undergoing an implant attempt
909669|NCT01064076|E1|Reported Event|S-ICD System|This is a single arm study
909670|NCT01063907|B1|Baseline|KW-2478 and Bortezomib|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and Bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts (overall N=15). The Phase 2 portion of the study enrolled 80 subjects to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2 / Bortezomib 1.3 mg/m^2)."
909671|NCT01063907|P2|Participant Flow|Phase II: KW-2478 130mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in Phase 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For the Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and bortezomib at the RP2D (KW-2478 175 mg/m^2/bortezomib1.3 mg/m^2)."
909672|NCT01063907|P1|Participant Flow|Phase 1: KW-2478 and Bortezomib|"The target population in Phase 1 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~For Phase 1, the design was a standard 3+3 study of KW-2478 (130 or 175 mg/m^2) and bortezomib(1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts."
909673|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
909674|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
909675|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
909676|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
909677|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909678|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909679|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909680|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909681|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909682|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909683|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909684|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909685|NCT01063907|O4|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
909686|NCT01063907|O3|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
910362|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
909687|NCT01063907|O2|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
909688|NCT01063907|O1|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Both agents administered on Days 1, 4, 8 and 11 of a 21 day cycle
909689|NCT01063907|O6|Outcome|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2).
909690|NCT01063907|O5|Outcome|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909691|NCT01063907|O4|Outcome|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909692|NCT01063907|O3|Outcome|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909693|NCT01063907|O2|Outcome|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909716|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909717|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
909904|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909694|NCT01063907|O1|Outcome|Phase 1 & 2: KW-2478 175 mg/m^2 and Bortezomib 1.3mg/m^2|"The target population in both Phase 1 and 2 were adults (≥18 years) of either gender with a confirmed history of MM by IMWG criteria had relapsed or failed to respond to 1–3 prior MM regimens with an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 and a life expectancy ≥ 3 months. Subjects had to have disease that could be evaluated by serum or urinary levels of M protein or serum free light chains in the absence of measurable M protein in serum or urine.~The Phase 1 portion of the study was a standard 3+3 study design of KW-2478 (130 or 175 mg/m^2) and Bortezomib (1.0 or 1.3 mg/m^2) on Days 1, 4, 8, and 11 of a 21-day cycle utilizing four dose-escalation cohorts.~The Phase 2 portion of the study was designed to determine the preliminary efficacy of KW 2478 and Bortezomib at the RP2D (KW-2478 175 mg/m^2/Bortezomib 1.3 mg/m^2)."
909695|NCT01063907|E6|Reported Event|Phase 2: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Phase 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle designed to determine the preliminary efficacy of KW 2478 + BTZ at the RP2D (KW-2478 175 mg/m^2/BTZ 1.3 mg/m^2).
909696|NCT01063907|E5|Reported Event|Phase 1 Cohort 4: KW-2478 175 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 4: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909697|NCT01063907|E4|Reported Event|Phase 1 Cohort 3: KW-2478 175 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 3: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909698|NCT01063907|E3|Reported Event|Phase 1 Cohort 2: KW-2478 130 mg/m^2 and Bortezomib 1.3 mg/m^2|Cohort 2: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909699|NCT01063907|E2|Reported Event|Phase 1 Cohort 1: KW-2478 130 mg/m^2 and Bortezomib 1.0 mg/m^2|Cohort 1: Both agents administered on Days 1, 4, 8, and 11 of a 21-day cycle with a standard 3+3 study design.
909700|NCT01063907|E1|Reported Event|Phase 1 and 2: KW-2478 and Bortezomib|KW-2478 and bortezomib: KW 2478 and bortezomib given on Days 1, 4, 8 and 11 of a 21 day cycle
909701|NCT01063881|B4|Baseline|Total|Total of all reporting groups
909702|NCT01063881|B3|Baseline|Dapoxetine 30 to 60 to 30 mg|13 patients took at least one dose of dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909703|NCT01063881|B2|Baseline|Dapoxetine 30 to 60 mg|124 of 125 patients took at least one dose of dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909704|NCT01063881|B1|Baseline|Dapoxetine 30 mg Only|144 of 147 patients took at least 1 dose of dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909705|NCT01063881|P3|Participant Flow|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909706|NCT01063881|P2|Participant Flow|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909707|NCT01063881|P1|Participant Flow|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909708|NCT01063881|O2|Outcome|Dapoxetine (Patients With IELT >1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909709|NCT01063881|O1|Outcome|Dapoxetine (Patients With IELT <1 Minute, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909710|NCT01063881|O2|Outcome|Dapoxetine (Patients With Acquired PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909711|NCT01063881|O1|Outcome|Dapoxetine (Patients With Life-long PE, Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909781|NCT01063595|B1|Baseline|All Participants|Participants received 1200 mL of Octaplas LG intravenously once and 1200 mL of Octaplas SD intravenously once in a crossover design.
923456|NCT01019928|O1|Outcome|AZD1386 95 mg|
909712|NCT01063881|O3|Outcome|Dapoxetine 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909713|NCT01063881|O2|Outcome|Dapoxetine 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909714|NCT01063881|O1|Outcome|Dapoxetine 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909715|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909934|NCT01063036|P1|Participant Flow|Entecavir + Tenofovir|"Entecavir (ETV) : Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909718|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909719|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
909720|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909721|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
909722|NCT01063881|O2|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909723|NCT01063881|O1|Outcome|Dapoxetine (Baseline)|Baseline measures were taken before administration of treatment.
909724|NCT01063881|O1|Outcome|Dapoxetine (Week 12)|Patients took Dapoxetine at a starting dose of one 30-mg tablet approximately 1-3 hours prior to sexual activity. After 4 weeks of treatment, the dosage of dapoxetine may have been increased to 60mg. The maximum recommended dosing frequency is once every 24 hours. The total duration of treatment was 12 weeks.
909725|NCT01063881|E3|Reported Event|Depoxetine (DPX) 30 to 60 to 30 mg|Patients who started on dapoxetine 30 mg, required an increase to dapoxetine 60 mg but later required a down-titration (decrease) to dapoxetine 30 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909726|NCT01063881|E2|Reported Event|Depoxetine (DPX) 30 to 60 mg|Patients who started on dapoxetine 30 mg and required an increase to dapoxetine 60 mg for the remainder of the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909727|NCT01063881|E1|Reported Event|Depoxetine (DPX) 30 mg Only|Patients who took dapoxetine 30 mg throughout the study. The maximum recommended dosing frequency is once every 24 hours. The duration of the treatment period was 12 weeks.
909728|NCT01063868|B3|Baseline|Total|Total of all reporting groups
909729|NCT01063868|B2|Baseline|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
909730|NCT01063868|B1|Baseline|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
909731|NCT01063868|P2|Participant Flow|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
909732|NCT01063868|P1|Participant Flow|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
909733|NCT01063868|O2|Outcome|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
909734|NCT01063868|O1|Outcome|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
909735|NCT01063868|E2|Reported Event|Oxycodone CR|Oxycodone controlled release (CR) 20 30 40 50 mg twice daily for 52 weeks
909736|NCT01063868|E1|Reported Event|Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 52 weeks
909737|NCT01063855|B3|Baseline|Total|Total of all reporting groups
909738|NCT01063855|B2|Baseline|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909739|NCT01063855|B1|Baseline|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909740|NCT01063855|P2|Participant Flow|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909741|NCT01063855|P1|Participant Flow|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909742|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
923457|NCT01019928|O2|Outcome|Placebo|
909743|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909744|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909745|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909746|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909747|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
910917|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
909748|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909749|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909750|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909751|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909752|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909753|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909754|NCT01063855|O2|Outcome|PDE5I + Dapoxetine|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909755|NCT01063855|O1|Outcome|PDE5I + Placebo|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909756|NCT01063855|O4|Outcome|PDE5I + Dapoxetine (Week 12)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
909757|NCT01063855|O3|Outcome|PDE5I + Dapoxetine (Baseline)|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction
909758|NCT01063855|O2|Outcome|PDE5I + Placebo (Week 12)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909759|NCT01063855|O1|Outcome|PDE5I + Placebo (Baseline)|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909760|NCT01063855|E2|Reported Event|PDE5I + DPX|Dapoxetine 30 mg to 60 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909761|NCT01063855|E1|Reported Event|PDE5I + PLACEBO|Placebo tablets identical in appearance to dapoxetine taken 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 12 weeks + PDE5I (phosphodiesterase-5 inhibitor) prescribed prior to study entry for the treatment of erectile dysfunction.
909762|NCT01063764|B1|Baseline|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909782|NCT01063595|P2|Participant Flow|Octaplas LG First, Then Octaplas SD|Participants received 1200 mL of Octaplas LG intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas SD intravenously once.
909783|NCT01063595|P1|Participant Flow|Octaplas SD First, Then Octaplas LG|Participants received 1200 mL of Octaplas SD intravenously once. At least 4 weeks later, participants received 1200 mL of Octaplas LG intravenously once.
909763|NCT01063764|P1|Participant Flow|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909764|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909765|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909766|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909767|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909768|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909769|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909770|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909771|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909784|NCT01063595|O2|Outcome|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
909785|NCT01063595|O1|Outcome|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
909772|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909773|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909774|NCT01063764|O1|Outcome|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909775|NCT01063764|E1|Reported Event|Levetiracetam|"First Period (4 weeks Up-titration and 10 weeks Evaluation): Dry syrup 50 %, 20 mg/kg/day or 1000 mg/day, 40 mg/kg/day or 2000 mg/day, 60 mg/kg/day or 3000 mg/day, twice daily administration Per Os (PO) for 14 weeks.~Second Period: Dry syrup 50 % or tablets (250 mg and 500 mg strengths), 20 to 60 mg/kg/day or 1000 to 3000 mg/day, twice daily administration Per Os (PO) until indication granted.~Withdrawal Period (6 weeks): Patients on the dose at 60 mg/kg/day or 3000 mg/day will be decreased to 40 mg/kg/day or 2000 mg/day for first 2 weeks and then to 20 mg/kg/day or 1000 mg/day for 2 additional weeks. For patients on the dose at 40 mg/kg/day or 2000 mg/day, the dosage will be decreased to 20 mg/kg/day or 1000 mg/day for 2 weeks and then the treatment with LEV will be stopped."
909776|NCT01063712|B1|Baseline|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
909777|NCT01063712|P1|Participant Flow|"Nit-Occlud® PDA-R Implantations Group"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have ducts in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
909778|NCT01063712|O1|Outcome|Number of Patients With Complete Regression of Dilation|"Children born with patent arterial duct develop cardiac insufficiency early in life. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the duct on time. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method.~This group of patients had 2-8 mm ductus, haven´t developed pulmonary hypertension and have enough weight to be treated.~Patients with left to right shunt show a dilation of left ventricle and left atrium. The quotient Left atrium/aortic ring is a well known method to estimate the grade of the dilation of the left atrium. The M-Mode method, is useful to assessed the regression of the ventricle after the ducts is closed. These observations were made at the beginning of the study and after six months."
909779|NCT01063712|O1|Outcome|Closure in the Control Period|"The number of patients who showed no more duct bloodflow (seen with color doppler echocardiography or color flow) in the control period is given as number and as percentage of the complete group."
909780|NCT01063712|E1|Reported Event|"Effectiveness of the Device: Nit-Occlud® PDA-R"|"Children born with patent arterial duct develop cardiac insufficiency early in life, show failure to thrive and frequent respiratory infections. Pulmonary hyperflow through the duct can lead to changes in the pulmonary vasculature and irreversible pulmonary hypertension. This can be prevented if we close the ducts on time. The classical method is open thorax surgery, which involves deep anaesthesia, a scar, possible complications (thorax deformities and instability) and a long stay in hospital. With the Interventional Closure of Patent Arterial Duct technique the patients stay only one day in hospital, the thorax is not open, and only slight sedation is needed. The device closure and the surgery have similar closure rates, but there are fewer complications using the intervention method, and it is also less expensive.~This group of patients were chosen because they have duct in mean sizes (2-8 mm), haven´t developed pulmonary hypertension and have enough weight to be treated."
909790|NCT01063595|E2|Reported Event|Octaplas SD|Participants received 1200 mL of Octaplas SD intravenously once.
909791|NCT01063595|E1|Reported Event|Octaplas LG|Participants received 1200 mL of Octaplas LG intravenously once.
909792|NCT01063517|B3|Baseline|Total|Total of all reporting groups
909793|NCT01063517|B2|Baseline|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909794|NCT01063517|B1|Baseline|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909795|NCT01063517|P2|Participant Flow|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909935|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909796|NCT01063517|P1|Participant Flow|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909797|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909798|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909799|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909800|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909801|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909802|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909803|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909804|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909805|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909806|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909807|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909808|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909809|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909810|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909811|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909812|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
923458|NCT01019928|O1|Outcome|AZD1386 95 mg|
909813|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909814|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909815|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909816|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909817|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909818|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909819|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909820|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909821|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909822|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909823|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909824|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909825|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909826|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909827|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909828|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909829|NCT01063517|O2|Outcome|Placebo+Paclitaxel|Matching placebo 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which placebo dose was increased to 200 mg bd as monotherapy.
909830|NCT01063517|O1|Outcome|Olaparib+Paclitaxel|Olaparib 100 mg twice daily in tablet formulation in combination with paclitaxel 80 mg/m2 intravenous on Days 1, 8, and 15 of a 4 week schedule. It was expected that patients would receive between 6 to 10 cycles of paclitaxel after which olaparib dose was increased to 200 mg bd as monotherapy.
909831|NCT01063517|E2|Reported Event|PLACEBO 100MG BD + PACLITAXEL / PLACEBO 200MG BD|
909832|NCT01063517|E1|Reported Event|OLAPARIB 100MG BD + PACLITAXEL / OLAPARIB 200MG BD|
909833|NCT01063348|B3|Baseline|Total|Total of all reporting groups
909834|NCT01063348|B2|Baseline|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
909835|NCT01063348|B1|Baseline|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
909836|NCT01063348|P2|Participant Flow|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
910363|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
909837|NCT01063348|P1|Participant Flow|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
909838|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
909839|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
909840|NCT01063348|O2|Outcome|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
909901|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909841|NCT01063348|O1|Outcome|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
909842|NCT01063348|E2|Reported Event|Placebo|"Matching placebo taken daily~Placebo: Matching placebo capsules taken in same amount of pills as the active medication."
909843|NCT01063348|E1|Reported Event|N-Acetyl Cysteine|"N-Acetyl Cysteine - 600mg tablets by mouth (dosing 1200mg - 3000mg qd)~N-Acetyl Cysteine: Week 0 (Visit 1) – Week 3 (V2): 1200mg/day (600mg po qam and 600mg po qpm) Week 3 (V2) – Week 6 (V3): 2400mg/day (1200mg po qam and 1200mg po qpm) Week 6 (V4) – Week 12 (V5): 3000mg/day (1200mg po qam and 1800mg po qpm)"
909844|NCT01063153|B3|Baseline|Total|Total of all reporting groups
909845|NCT01063153|B2|Baseline|ADHD|Subjects with ADHD
909846|NCT01063153|B1|Baseline|Control|Subjects without ADHD
909847|NCT01063153|P2|Participant Flow|ADHD|Subjects with ADHD were assessed with EEG before and after treatment with Concerta
909848|NCT01063153|P1|Participant Flow|Control|Controls without ADHD were assessed using EEG
909849|NCT01063153|O4|Outcome|Control Group and Visual Go Task|Participants without a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
909850|NCT01063153|O3|Outcome|ADHD and Visual Go Task|Participants with a DSM-IV diagnosis of ADHD completed the Go Visual Task, in which they had to perform a motor response to a stimulus.
909851|NCT01063153|O2|Outcome|Control Group and Visual NoGo Task|Participants without a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
909852|NCT01063153|O1|Outcome|ADHD and Visual NoGo Task|Participants with a DSM-IV diagnosis of ADHD completed the NoGo Visual Task, in which they had to refrain from responding.
909853|NCT01063153|O2|Outcome|Controls|Controls without ADHD were assessed with a one-time EEG, only.
909854|NCT01063153|O1|Outcome|ADHD|Subjects with ADHD were assessed before and after treatment.
909855|NCT01063153|E2|Reported Event|ADHD|Subjects with ADHD were assessed with EEG before and after open-label treatment with Concerta.
909856|NCT01063153|E1|Reported Event|Control|Subjects without ADHD were assessed using EEG.
909857|NCT01063075|B1|Baseline|All Participants (Group A, B, C and D)|"Group D:~Cycle 1:400 mg/m² cetuximab week (w) 1,day(d) 1.Carboplatin(AUC=5) on w 1, d 1.Optional 1000 mg/m²/d 5-FU given as a 96-hour C.I. starting(strt) on w 1, d 1.~Group C:~Cycle 1:Carboplatin(AUC=5) on w 1,d 1. 400 mg/m² cetuximab on w 2, d 1.Cetuximab 250 mg/m ² on w 3 and 4, d 1.~Cycle 2-6:Carboplatin(AUC=5) and 250 mg/m² cetuximab on w 1, d 1.1000 mg/m²/d 5-FU given as a 96-hour C.I. strt on w 1, d 1.250 mg/m² cetuximab on w 2 and 3, d 1.~Group B:~Cycle 1:400 mg/m² cetuximab on w 1, d 1. 250 mg/m ² cetuximab on w 2 and 3, d 1.~Cycle 2:Carboplatin(AUC=5) w 1, d 1.1000 mg/m ²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m ² cetuximab w 1- 3, d 1.~Group A:~Cycle 1:Carboplatin(AUC=5) on w 1, d 1. 1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1.~400 mg/m² cetuximab on w 2, d 1 and 250 mg/m² cetuximab on w 3, d 1. Cycle 2:Carboplatin(AUC=5) given I.V on w 1, d 1.1000 mg/m²/d 5-FU given as 96-hour C.I. strt on w 1, d 1. 250 mg/m² cetuximab on w 1-3, d 1."
909858|NCT01063075|P4|Participant Flow|Cetuximab and Carboplatin (D)|"Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
909859|NCT01063075|P3|Participant Flow|Cetuximab and Carboplatin (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909860|NCT01063075|P2|Participant Flow|Cetuximab and Carboplatin (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
909861|NCT01063075|P1|Participant Flow|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 milligrams per square meter (mg/m ²) cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
909862|NCT01063075|O1|Outcome|Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
910044|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
909863|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909902|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909864|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909865|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
909866|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909867|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909868|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
909869|NCT01063075|O2|Outcome|Cetuximab and Carboplatin (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909870|NCT01063075|O1|Outcome|Cetuximab (B and C)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1.~Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day 1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909871|NCT01063075|O1|Outcome|Cetuximab and Carboplatin (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on week 1, day 1. Carboplatin area under the curve (AUC=5) administered I.V on week 1, day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on week 1, day 1."
909872|NCT01063075|E4|Reported Event|Carboplatin and Cetuximab (D)|"Group D:~Cycle 1 (1 week, combination therapy):~400 milligrams per square meter (mg/m ²) cetuximab administered intravenously (I.V) on day 1. Carboplatin area under the curve (AUC=5) administered I.V on day 1.~Optional 5- fluorouracil (FU) administered as a 96-hour continuous infusion (C.I.) of 1000 mg/ m ²/day administered starting on day 1."
909988|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
923459|NCT01019928|O2|Outcome|Placebo|
909873|NCT01063075|E3|Reported Event|Carboplatin and Cetuximab (C)|"Group C:~Cycle 1 (4 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1.1000 mg/m ²/day 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3 and 4, day1.~Cycle 2-6 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week1,day1.1000 mg/m ²/d 5-FU as a 96-hour C.I. starting on week1, day1. 250 mg/m ² cetuximab administered I.V on Week 1-3, day 1."
909903|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909874|NCT01063075|E2|Reported Event|Carboplatin and Cetuximab (B)|"Group B:~Cycle 1 (3 weeks, single-agent cetuximab):~400 mg/m² cetuximab administered I.V on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 2 and 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V weeks 1- 3,day 1."
909875|NCT01063075|E1|Reported Event|Carboplatin and Cetuximab (A)|"Group A:~Cycle 1 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1.~400 mg/m ² cetuximab administered I.V on week 2, day 1. 250 mg/m ² cetuximab administered I.V on week 3, day 1.~Cycle 2 (3 weeks, combination therapy):~Carboplatin (AUC=5) administered I.V on week 1, day 1. 1000 mg/m ²/d 5-FU administered as a 96-hour C.I. starting on week 1, day 1. 250 mg/m ² cetuximab administered I.V on weeks 1- 3, day 1."
909876|NCT01063062|B3|Baseline|Total|Total of all reporting groups
909877|NCT01063062|B2|Baseline|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909878|NCT01063062|B1|Baseline|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909879|NCT01063062|P2|Participant Flow|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909880|NCT01063062|P1|Participant Flow|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909881|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909882|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909883|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909884|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909885|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909886|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909887|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909888|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909889|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909890|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909891|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909892|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909893|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909894|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909895|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909896|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909897|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909898|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909989|NCT01062763|E2|Reported Event|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
910045|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
909899|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909900|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909905|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909906|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909907|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909908|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909909|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909910|NCT01063062|O1|Outcome|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909911|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909912|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909913|NCT01063062|O2|Outcome|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909914|NCT01063062|O1|Outcome|Tocilizumab|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909915|NCT01063062|E2|Reported Event|Tocilizumab + MTX|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions). Participants taking concomitant methotrexate (MTX) at Baseline remained on a stable dose as per standard of care at the Investigator's discretion.
909916|NCT01063062|E1|Reported Event|Tocilizumab Monotherapy|Participants received an 8 mg/kg tocilizumab intravenous (IV) infusion once every 4 weeks for 24 weeks (6 infusions).
909917|NCT01063049|B4|Baseline|Total|Total of all reporting groups
909918|NCT01063049|B3|Baseline|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909919|NCT01063049|B2|Baseline|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909920|NCT01063049|B1|Baseline|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
909921|NCT01063049|P3|Participant Flow|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909922|NCT01063049|P2|Participant Flow|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909923|NCT01063049|P1|Participant Flow|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
909924|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909925|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909926|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
909927|NCT01063049|O3|Outcome|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909990|NCT01062763|E1|Reported Event|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
909928|NCT01063049|O2|Outcome|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909929|NCT01063049|O1|Outcome|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
909930|NCT01063049|E3|Reported Event|Gatorade/Miralax + Bisacodyl|Gatorade 64 oz (1/2 gallon), Miralax 306 g and Bisacodyl 10 mg (two 5 mg pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and Bisacodyl 10 mg at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909931|NCT01063049|E2|Reported Event|Gatorade/Miralax + Placebo|Gatorade 64 oz (1/2 gallon), Miralax 306 g and a placebo (two 0.4 mg folic acid pills) to be consumed the day before the colonoscopy as follows: Miralax 51 g and placebo at 12 noon. Gatorade 64 oz mixed with Miralax 255 g from about 5 PM to 9 PM.
909932|NCT01063049|E1|Reported Event|Nulytely|Nulytely (or Trilyte) 128 oz (1 gallon) to be consumed from about 5 PM to 9 PM the night before the colonoscopy.
909933|NCT01063036|B1|Baseline|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909936|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909937|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909938|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909939|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909940|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909941|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909942|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909943|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909944|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909945|NCT01063036|O1|Outcome|Entecavir + Tenofovir|"Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks~Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks"
909946|NCT01063036|E1|Reported Event|Entecavir + Tenofovir|Entecavir (ETV): Tablets, Oral, 1 mg, once daily, 96 weeks Tenofovir disoproxil fumarate (TDF): Tablets, Oral, 300 mg, once daily, 96 weeks
909947|NCT01062841|B3|Baseline|Total|Total of all reporting groups
909948|NCT01062841|B2|Baseline|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909949|NCT01062841|B1|Baseline|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909950|NCT01062841|P2|Participant Flow|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices. Surveillance cultures and data was collected for outcome comparison only.
909951|NCT01062841|P1|Participant Flow|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all nursing home residents with indwelling devices; active screening for MDRO (multidrug resistant organisms) monthly using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909952|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909991|NCT01062425|B3|Baseline|Total|Total of all reporting groups
909992|NCT01062425|B2|Baseline|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
909993|NCT01062425|B1|Baseline|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
910046|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
909953|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909954|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909955|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
910244|NCT01061008|E2|Reported Event|Treatment as Usual|
909956|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909957|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909958|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909959|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909960|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909961|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909962|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909963|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909964|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909965|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909966|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
910043|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
910364|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
909967|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909968|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909969|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909970|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909971|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909972|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909973|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909974|NCT01062841|O2|Outcome|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909975|NCT01062841|O1|Outcome|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909976|NCT01062841|E2|Reported Event|Control|Nursing homes allocated to the control group will continue with their standard infection control procedures. No changes will be made to their practices.
909977|NCT01062841|E1|Reported Event|Intervention: Targeted Infection Control Program|"Nursing homes allocated to the Intervention Arm will implement a series of new infection control programs.~Targeted Infection Control: Component 1: Institute enhanced barrier precautions for all NH residents with indwelling devices; active screening for MDROs (monthly) using cultures collected from multiple body sites to identify asymptomatic MDRO carriage in these residents; and dissemination of results to clinical staff and administration.~Component 2: Structured, active surveillance for infections using standardized definitions in residents with indwelling devices and dissemination of results to clinical staff and administration.~Component 3: A hand hygiene promotion program. Component 4: A structured educational program pertaining to indwelling device care for healthcare workers."
909978|NCT01062763|B3|Baseline|Total|Total of all reporting groups
909979|NCT01062763|B2|Baseline|Placebo|
909980|NCT01062763|B1|Baseline|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
909981|NCT01062763|P2|Participant Flow|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~placebo : addition of placebo 1 to 2 tablets daily~spironolactone : 25 to 50 mg once daily"
909982|NCT01062763|P1|Participant Flow|Placebo|1tablet of matching placebo trated up to 2 if neccessary
909983|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
909984|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
909985|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
909986|NCT01062763|O1|Outcome|Addition of Spironolactone|"spironolactone is added to previous antihypertensive treatment~spironolactone : 25 uptrated if necessary to 50 mg once daily"
909987|NCT01062763|O2|Outcome|Placebo|1tablet of matching placebo uptrated to 2 if neccessary
909994|NCT01062425|P2|Participant Flow|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
909995|NCT01062425|P1|Participant Flow|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
909996|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
909997|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
909998|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
909999|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
910000|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
911259|NCT01057251|P2|Participant Flow|Placebo|Dose-matched placebo, once daily oral administration
910001|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
910002|NCT01062425|O2|Outcome|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
910003|NCT01062425|O1|Outcome|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
910004|NCT01062425|E2|Reported Event|Cediranib, TMZ, and RT|Cediranib (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + cediranib followed by cediranib monotherapy (4 weeks) followed by TMZ + cediranib for 12 cycle maximum
910005|NCT01062425|E1|Reported Event|Placebo, TMZ, and RT|Placebo (3 days) followed by radiation therapy (RT) + daily temozolomide (TMZ) + placebo followed by placebo monotherapy (4 weeks) followed by TMZ + placebo for 12 cycle maximum
910006|NCT01062308|B3|Baseline|Total|Total of all reporting groups
910007|NCT01062308|B2|Baseline|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
910008|NCT01062308|B1|Baseline|Taping|Procedure for preventing shoulder injury
910009|NCT01062308|P2|Participant Flow|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
910010|NCT01062308|P1|Participant Flow|Taping|Procedure for preventing shoulder injury
910011|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
910012|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
910013|NCT01062308|O2|Outcome|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
910014|NCT01062308|O1|Outcome|Taping|Procedure for preventing shoulder injury
910015|NCT01062308|E2|Reported Event|Sham Taping|Sham Taping was applied without stretching the concerned muscles.
910016|NCT01062308|E1|Reported Event|Taping|Procedure for preventing shoulder injury
910017|NCT01062269|B1|Baseline|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
910018|NCT01062269|P1|Participant Flow|Cholestyramine 4 Grams vs 12 Grams vs Tang|Although 3 different arms are used in this study, there is only one study group. All subjects receive all 3 treatment arms on the same day, just in varying orders. Thus, the participant flow and baseline characteristics are the same for all three arms.
910019|NCT01062269|O3|Outcome|Tang|
910020|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
910021|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
910022|NCT01062269|O3|Outcome|Tang|
910023|NCT01062269|O2|Outcome|Cholestyramine 12 Grams|
910024|NCT01062269|O1|Outcome|Cholestyramine 4 Grams|
910025|NCT01062269|E3|Reported Event|Tang|
910026|NCT01062269|E2|Reported Event|Cholestyramine 12 Grams|
910027|NCT01062269|E1|Reported Event|Cholestyramine 4 Grams|
910028|NCT01062256|B4|Baseline|Total|Total of all reporting groups
910029|NCT01062256|B3|Baseline|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910030|NCT01062256|B2|Baseline|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910031|NCT01062256|B1|Baseline|Placebo|One placebo tablet administered orally as a single dose
910032|NCT01062256|P3|Participant Flow|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910033|NCT01062256|P2|Participant Flow|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910034|NCT01062256|P1|Participant Flow|Placebo|One placebo tablet administered orally as a single dose
910035|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910036|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910037|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
910038|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910039|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910040|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
910041|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910042|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910047|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910048|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910049|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
910050|NCT01062256|O3|Outcome|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910051|NCT01062256|O2|Outcome|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910052|NCT01062256|O1|Outcome|Placebo|One placebo tablet administered orally as a single dose
910053|NCT01062256|E3|Reported Event|Guaifenesin|One 400 milligrams (mg) immediate release tablet administered orally as a single dose
910054|NCT01062256|E2|Reported Event|Buckwheat Honey|10 milliliters (mL) administered orally as a single dose
910055|NCT01062256|E1|Reported Event|Placebo|One placebo tablet administered orally as a single dose
910056|NCT01062230|B1|Baseline|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
910057|NCT01062230|P1|Participant Flow|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
910058|NCT01062230|O1|Outcome|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
910059|NCT01062230|E1|Reported Event|All Patients|"All participants enrolled.~Bortezomib (Velcade): Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 4, 8, and 11 q. 21 days times three cycles.~Patients will undergo three 21-day cycles."
910060|NCT01062165|B1|Baseline|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
910061|NCT01062165|P1|Participant Flow|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
910062|NCT01062165|O1|Outcome|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
910063|NCT01062165|E1|Reported Event|Capsofungin|"Six volunteers will have a body mass index (BMI) less than 25 kg/m2, 6 will have a BMI 25-40 kg/m2, and 6 will have a BMI greater than 40 kg/m2.~Caspofungin : Caspofungin 70mg IV (each volunteer will only receive one dose of the study drug)"
910064|NCT01062113|B4|Baseline|Total|Total of all reporting groups
910065|NCT01062113|B3|Baseline|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910066|NCT01062113|B2|Baseline|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910067|NCT01062113|B1|Baseline|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
910068|NCT01062113|P3|Participant Flow|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910069|NCT01062113|P2|Participant Flow|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910070|NCT01062113|P1|Participant Flow|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
910071|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910072|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910073|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910074|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910075|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910076|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200mg|Included participants who received Celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910077|NCT01062113|O2|Outcome|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910078|NCT01062113|O1|Outcome|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910079|NCT01062113|E3|Reported Event|Additional Dose Placebo|Included participants who received placebo as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910080|NCT01062113|E2|Reported Event|Additional Dose Celecoxib 200 mg|Included participants who received celecoxib 200 mg as an additional dose from 5 to 12 hours after the initial dose (celecoxib 400 mg).
910081|NCT01062113|E1|Reported Event|Initial Dose Celecoxib 400 mg|Included the participants who received initial dose of celecoxib 400 mg only
910082|NCT01062074|B1|Baseline|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
910083|NCT01062074|P1|Participant Flow|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
910084|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
910085|NCT01062074|O1|Outcome|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
910086|NCT01062074|E1|Reported Event|Korean Participants|Korean participants who received vaccination with GARDASIL, had Case Report Forms available, and did not violate the protocol
910087|NCT01062061|B1|Baseline|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910088|NCT01062061|P1|Participant Flow|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910089|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910090|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910091|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910092|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910093|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910094|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910095|NCT01062061|O2|Outcome|Age ≥2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910096|NCT01062061|O1|Outcome|Age <2 Years|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910097|NCT01062061|O2|Outcome|Female Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910098|NCT01062061|O1|Outcome|Male Participants|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910099|NCT01062061|O1|Outcome|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910100|NCT01062061|E1|Reported Event|VARIVAX|Attenuated live varicella vaccine was administered in usual practice. Recommended dosing is a single 0.5 mL subcutaneous injection in children 12 months to 12 years of age.
910101|NCT01061866|B1|Baseline|Thalidomide|Tablets thalidomide at 200 mg dosage 100 mg in the morning and 100 mg in the night was administered daily during a twelve month period.
910102|NCT01061866|P1|Participant Flow|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
910103|NCT01061866|O1|Outcome|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
910104|NCT01061866|E1|Reported Event|Thalidomide|Thalidomide tablets 200 mg per day during twelve months was administrated to 7 males with 25 years old mean and refractory epilepsy, without modifying their previous treatment.
910105|NCT01061775|B1|Baseline|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
910106|NCT01061775|P1|Participant Flow|Exenatide|Participants received 5mcg of exenatide twice a day for 4 weeks and increased to 10 mcg twice a day for 20 weeks.
910107|NCT01061775|O1|Outcome|Exenatide|"Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.~Of 55 potential participants screened, 19 agreed to participate. Reasons for decline included reluctance to add another medication to their current regimens, travel distance, and aversion to an injectable medication. Sixteen patients completed the study. Of the three who failed to complete the study, one was lost to follow up, and two dropped out due to difficulty adhering to the twice daily injections, but none experienced significant side effects from therapy. Three of the 19 patients were on chronic metformin therapy."
910108|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
910109|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
910110|NCT01061775|O1|Outcome|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
910111|NCT01061775|E1|Reported Event|Exenatide|Exenatide: 5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 20 weeks.
910112|NCT01061710|B1|Baseline|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910113|NCT01061710|P1|Participant Flow|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910114|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910190|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910365|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
910115|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910116|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910117|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910118|NCT01061710|O1|Outcome|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910119|NCT01061710|E1|Reported Event|Varenicline (Champix®)|The usual adult dosage for oral use is as follows: Day 1 through Day 3, 0.5 mg once daily after eating; Day 4 through Day 7, 0.5 mg twice daily after eating in the morning and evening; and Day 8 and thereafter, 1 mg twice daily after eating in the morning and evening. Treatment period was 12 weeks. Participants were retreated within 52 weeks of initial treatment.
910120|NCT01061671|B3|Baseline|Total|Total of all reporting groups
910121|NCT01061671|B2|Baseline|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
910122|NCT01061671|B1|Baseline|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
910123|NCT01061671|P2|Participant Flow|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
910124|NCT01061671|P1|Participant Flow|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
910125|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
910126|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
910127|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
910128|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
910129|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
910130|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
910131|NCT01061671|O2|Outcome|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
910132|NCT01061671|O1|Outcome|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
910133|NCT01061671|E2|Reported Event|Placebo|"Matched placebo pill daily~Placebo: Matched placebo pill daily"
910134|NCT01061671|E1|Reported Event|Simvastatin|"40 mgms of simvastatin daily~Simvastatin: 40 mgms of simvastatin daily"
910135|NCT01061606|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910136|NCT01061606|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910137|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910138|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910139|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910140|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910141|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910142|NCT01061606|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910143|NCT01061606|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV"
910144|NCT01061567|B1|Baseline|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910145|NCT01061567|P1|Participant Flow|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910146|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910147|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910148|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910149|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910150|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910151|NCT01061567|O1|Outcome|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910152|NCT01061567|E1|Reported Event|All Patients|Patients with Parkinson’s disease in routine clinical practice.
910153|NCT01061476|B1|Baseline|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
910154|NCT01061476|P1|Participant Flow|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
910155|NCT01061476|O1|Outcome|Single Arm - Sleep Apnea|"Each participant had 3 sleep studies. Sleep Study #1 - the patient did not have the Provent™ device on to assess baseline sleep apnea severity. On sleep study #2 - the patient used the Provent™ device to re-assess changes in sleep apnea severity. On sleep study #3, the patient used Provent™ for assessment of the physiological effects of the device on breathing during sleep.~Participants did not use Provent™ outside of the sleep laboratory.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
910156|NCT01061476|E1|Reported Event|Single Arm - Sleep Apnea|"All participants will undergo 3 sleep studies - one off treatment, one on treatment, and one night to assess the physiological effects of the device on breathing during sleep.~Provent™ : Provent™ is an expiratory nasal resistance device applied to the nares via adhesive."
910157|NCT01061385|B3|Baseline|Total|Total of all reporting groups
910158|NCT01061385|B2|Baseline|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
910159|NCT01061385|B1|Baseline|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
910160|NCT01061385|P2|Participant Flow|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
910161|NCT01061385|P1|Participant Flow|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
910162|NCT01061385|O2|Outcome|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
910163|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
910164|NCT01061385|O2|Outcome|Control|Control subjects receiving diet and exercise counseling only
910165|NCT01061385|O1|Outcome|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
910166|NCT01061385|E2|Reported Event|Control Arm|"Patients presenting for weight loss using behaviour modification (diet and exercise) alone.~Behavioral modification: Diet and exercise"
910167|NCT01061385|E1|Reported Event|ReShape Intragastric Balloon|"Patients receiving the ReShape Intragastric Balloon~ReShape Intragastric Balloon: Placement of ReShape Medical Intragastric Balloon for twenty four weeks"
910168|NCT01061359|B1|Baseline|Entire Study Population|Includes all groups enrolled in the study
910169|NCT01061359|P1|Participant Flow|Entire Study Population|Includes all groups enrolled in the study
910170|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
910171|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
910172|NCT01061359|O1|Outcome|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
910173|NCT01061359|E1|Reported Event|Epirubicin|Includes groups enrolled to receive all treatments of epirubicin
910174|NCT01061333|B1|Baseline|All Participants|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, nedocromil or montelukast, nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
910175|NCT01061333|P2|Participant Flow|Placebo-Nedocromil-Montelukast-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
910176|NCT01061333|P1|Participant Flow|Placebo-Montelukast-Nedocromil-Mometasone|Over the course of four 3-day treatment regimens, participants received a single dose of each drug starting with placebo, crossover of nedocromil or montelukast, crossover of nedocromil or montelukast, ending with mometasone; with a 20-day washout between each of the four treatment periods.
910177|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910178|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910179|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910180|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910181|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910182|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910183|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910184|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910185|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910186|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910187|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910188|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910189|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910191|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910192|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910193|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910194|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910195|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910196|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910197|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910198|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910199|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910200|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910201|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
911260|NCT01057251|P1|Participant Flow|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
910202|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910203|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910204|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, Montelukast placebo tablet, Mometasone placebo twisthaler
910205|NCT01061333|O4|Outcome|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910206|NCT01061333|O3|Outcome|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910207|NCT01061333|O2|Outcome|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910208|NCT01061333|O1|Outcome|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910209|NCT01061333|E4|Reported Event|Mometasone|Mometasone furoate 400 mcg, administered by twisthaler, 2 hours prior to allergen challenge
910210|NCT01061333|E3|Reported Event|Montelukast|Montelukast 10 mg, administered in a single tablet, 2 hours prior to allergen challenge
910211|NCT01061333|E2|Reported Event|Nedocromil|Nedocromil 4 mg, administered by metered dose inhaler, 1 hour prior to allergen challenge
910212|NCT01061333|E1|Reported Event|Placebo|Nedocromil placebo metered dose inhaler, montelukast placebo tablet, mometasone placebo twisthaler
910213|NCT01061177|B1|Baseline|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910214|NCT01061177|P1|Participant Flow|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910215|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910216|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910217|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910218|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910219|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910220|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910221|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910222|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910223|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910224|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910225|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910226|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910227|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910228|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910229|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910230|NCT01061177|O1|Outcome|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910231|NCT01061177|E1|Reported Event|Nilotinib|This was a single-arm study; therefore all participants received nilotinib (AMN107) 300 mg bid given as two 150 mg capsules twice daily.
910232|NCT01061034|B1|Baseline|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
910233|NCT01061034|P1|Participant Flow|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
910366|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
910234|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
910235|NCT01061034|O1|Outcome|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
910236|NCT01061034|E1|Reported Event|Aspirin Then Aspirin Plus Omeprazole|7 days of Aspirin (100mg) alone, followed by 14 days of Aspirin and Omeprazole (20mg BID for 3 days and then 20mg once daily
910237|NCT01061008|B3|Baseline|Total|Total of all reporting groups
910238|NCT01061008|B2|Baseline|Treatment as Usual|
910239|NCT01061008|B1|Baseline|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
910240|NCT01061008|P2|Participant Flow|Treatment as Usual|
910241|NCT01061008|P1|Participant Flow|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
910242|NCT01061008|O2|Outcome|Treatment as Usual|
910243|NCT01061008|O1|Outcome|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
910245|NCT01061008|E1|Reported Event|Handgrip Exercise|Handgrip exercise - patients allocated to this intervention will carry out an eight week post operative progressive handgrip exercise training program
910246|NCT01060670|B3|Baseline|Total|Total of all reporting groups
910247|NCT01060670|B2|Baseline|Control Treatment|Control Treatment consisted of moist wound therapy and was comprised of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing and a gauze wrap and, an offloading/protective device
910248|NCT01060670|B1|Baseline|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing and a gauze wrap and, an offloading/protective device were to be used in conjunction with the IDRT.
910249|NCT01060670|P2|Participant Flow|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910250|NCT01060670|P1|Participant Flow|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910251|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910252|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910253|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910254|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910255|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910256|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910257|NCT01060670|O2|Outcome|Moist Wound Therapy|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910258|NCT01060670|O1|Outcome|Dermal Replacement Device|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910259|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910260|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910261|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910262|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910263|NCT01060670|O2|Outcome|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910264|NCT01060670|O1|Outcome|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910265|NCT01060670|E2|Reported Event|Control Treatment|Control Treatment was applied to sharply debrided study ulcer wound bed within an aseptic field. Moist wound therapy consisted of 0.9% sodium chloride gel, applied in conjunction with a non-adherent foam dressing, gauze wrap and an offloading/protective device.
910266|NCT01060670|E1|Reported Event|Active Treatment|INTEGRA® Dermal Regeneration Template (IDRT) was applied to sharply debrided study ulcer wound bed within an aseptic field. A non-adherent foam dressing, gauze wrap and an offloading/protective device were used in conjunction with the IDRT.
910267|NCT01060592|B3|Baseline|Total|Total of all reporting groups
910268|NCT01060592|B2|Baseline|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
910269|NCT01060592|B1|Baseline|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910270|NCT01060592|P2|Participant Flow|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910271|NCT01060592|P1|Participant Flow|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
911261|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
910272|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
910273|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910274|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
910275|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910276|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
910277|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910278|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
910279|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910280|NCT01060592|O2|Outcome|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
910281|NCT01060592|O1|Outcome|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910282|NCT01060592|E2|Reported Event|Stoma Adjustment at Surgery|The first band adjustment will be made at surgery versus historical controls where the adjustment is not made for 3-4 weeks post-surgery
910283|NCT01060592|E1|Reported Event|Historic|Weight loss profile over time for 50 patients in the first 12 months after surgery as derived from historic control records
910284|NCT01060553|B1|Baseline|Arm 1|24 semi-individualized acupuncture treatments over 12 weeks. The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
910285|NCT01060553|P2|Participant Flow|Wait List Control|this group was originall randomly assigned to a wait list control. due to severe recruitment and retention problems, data was collected in those willing to be treated after the wait list. this treatment data is combined with the original treatment group. this group received the same treatment, namely The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
910286|NCT01060553|P1|Participant Flow|Active Treatment|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
910287|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue. The front treatment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: Traditional Chinese theory explains acupuncture as a technique for balancing the flow of energy - believed to flow through pathways (meridians) in your body. Acupuncture involves the insertion of extremely thin, stainless steel, sterile needles in subcutaneous tissue or muscle at strategic points on your body which correspond to the acupuncture meridians. The Traditional Chinese Medicine (TCM) interview also includes looking at the tongue and feeling the pulse before deciding on all the points to be used."
910312|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910288|NCT01060553|O1|Outcome|Arm 1|"The treatment program consisted of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen~Acupuncture treatment: This project was initially designed as a randomized trial with one group receiving treatment and the other wait list control, with delayed treatment. Due to extremely high dropout and cancellations and failure to return for post assessment, a midpoint assessment was added. Analysis was done on pre and post measures of all subjects who completed at least the midpoint assessment"
910289|NCT01060553|E1|Reported Event|Arm 1|The treatment program will consist of 24 semi-individualized acupuncture treatments over 12 weeks. It combines front and back treatments to avoid point fatigue (tolerance due to frequent use). The front treat-ment uses 11 needles, bilateral at acupuncture points LR3, PC6, HT7, ST36, SP6, and one at Yintang; the back treatment uses 14 needles, bilateral at points GB20, and BL14, 15, 18, 20, 21, and 23. There are 15 other points from which the flexibly prescribed points could be chosen
910290|NCT01060540|B3|Baseline|Total|Total of all reporting groups
917374|NCT01037218|E3|Reported Event|Udenafil 150mg|Udenafil 150mg tablets
910291|NCT01060540|B2|Baseline|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
910292|NCT01060540|B1|Baseline|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
910293|NCT01060540|P2|Participant Flow|CR+EYE|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~eye disease counseling"
910294|NCT01060540|P1|Participant Flow|CR+G|"conventional risk counseling for type 2 diabetes (lifetime risk, fasting plasma glucose, and family history)~results of genetic testing for type 2 diabetes based on the genes TCF7L2, PPARG, or KCNJ11"
910295|NCT01060540|O2|Outcome|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
910296|NCT01060540|O1|Outcome|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
910297|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
910298|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
910299|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
910300|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
910301|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
910302|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
910303|NCT01060540|O2|Outcome|CR+EYE|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus control eye disease counseling~Conventional risk counseling for type 2 diabetes: Conventional risk counseling: lifetime risk, fasting plasma glucose results, and family history."
910304|NCT01060540|O1|Outcome|CR+G|"conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing~genetic testing for type 2 diabetes: TCF7L2, PPARG, or KCNJ11"
910305|NCT01060540|E2|Reported Event|CR+EYE|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus eye disease counseling
910306|NCT01060540|E1|Reported Event|CR+G|conventional risk counseling (lifetime risk, fasting plasma glucose, and family history) plus genetic testing for type 2 diabetes
910307|NCT01060150|B1|Baseline|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910308|NCT01060150|P1|Participant Flow|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910309|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910310|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910311|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910313|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910314|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910315|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910316|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910317|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910318|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910319|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910320|NCT01060150|O1|Outcome|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910321|NCT01060150|E1|Reported Event|OROS Methylphenidate HCl|Osmotic Release Oral System (OROS) Methylphenidate hydrochloride (HCl) tablet orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) and 27 mg for those more than or equal to 30 kg; the dose could be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg orally once daily up to Week 12
910322|NCT01060124|B1|Baseline|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910323|NCT01060124|P1|Participant Flow|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910324|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910325|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910326|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910327|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910328|NCT01060124|O1|Outcome|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910329|NCT01060124|E1|Reported Event|Transdermal Therapeutic System (TTS)-Fentanyl D-trans|Fentanyl D-trans was applied as transdermal patch releasing drug at the rate of 12.5 microgram per hour (mcg/hr) for 3 days with a dose ranging from 12 mcg/hr to 50 mcg/hr.
910330|NCT01060111|B4|Baseline|Total|Total of all reporting groups
910331|NCT01060111|B3|Baseline|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
910332|NCT01060111|B2|Baseline|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910359|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
923460|NCT01019928|O1|Outcome|AZD1386 95 mg|
910333|NCT01060111|B1|Baseline|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910334|NCT01060111|P3|Participant Flow|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
910335|NCT01060111|P2|Participant Flow|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910336|NCT01060111|P1|Participant Flow|Topiramate Standard|Topiramate 25 milligram (mg) was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910337|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
910338|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
910339|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
910340|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
910341|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
910342|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
910343|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
910344|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every 2 Weeks till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
910345|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate Capsule 25 mg administered once daily till week 1. From Week 2 dose was increased by 25 mg every Week till a dose of 50 mg to 100 mg up to Week 6 and a dose of 50 mg to 100 mg twice daily up to Week 10 as per Physician's discretion.
910346|NCT01060111|O3|Outcome|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
910347|NCT01060111|O2|Outcome|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910348|NCT01060111|O1|Outcome|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910349|NCT01060111|E3|Reported Event|Topiramate Slow and Propranolol Booster|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion. Propranolol 80 mg was administered once daily, 40 mg in the morning and 40 mg in the evening up to Week 6.
910350|NCT01060111|E2|Reported Event|Topiramate Slow|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 2-weeks up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910351|NCT01060111|E1|Reported Event|Topiramate Standard|Topiramate 25 mg was administered once daily and the dose was increased by 25 mg per day at an interval of 1-week up to a dose of 50 mg to 100 mg up to Week 6. A maintenance dose of 50 mg to 100 mg was administered twice daily up to Week 10 as per Physician's discretion.
910352|NCT01060072|B3|Baseline|Total|Total of all reporting groups
910353|NCT01060072|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
910354|NCT01060072|B1|Baseline|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
910355|NCT01060072|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
910356|NCT01060072|P1|Participant Flow|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
910357|NCT01060072|O2|Outcome|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
910358|NCT01060072|O1|Outcome|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
910367|NCT01060072|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate ophthalmic suspension.
910368|NCT01060072|E1|Reported Event|Loteprednol Etabonate|Loteprednol etabonate 0.5% ophthalmic suspension
910369|NCT01060059|B3|Baseline|Total|Total of all reporting groups
910370|NCT01060059|B2|Baseline|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910371|NCT01060059|B1|Baseline|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910372|NCT01060059|P2|Participant Flow|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910373|NCT01060059|P1|Participant Flow|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910374|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
910375|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
910376|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
910377|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
910378|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
910379|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
910380|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
910381|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
910382|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
910383|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
910384|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
910385|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
910386|NCT01060059|O2|Outcome|Basal Insulin|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin. basal insulin : subcutaneous injection, dosing according to physician's clinical judgment
910387|NCT01060059|O1|Outcome|Exenatide|The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide. Exenatide subcutaneous injection, 5mcg or 10mcg, twice a day.
910388|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910389|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910468|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910390|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910391|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910392|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910393|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910394|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910395|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910396|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910397|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910398|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910399|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910400|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910401|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910402|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910403|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910404|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910405|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910406|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910407|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910408|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910409|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910410|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
911567|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
910411|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910412|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910413|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910414|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910415|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910416|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910417|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910418|NCT01060059|O2|Outcome|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910419|NCT01060059|O1|Outcome|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910420|NCT01060059|E2|Reported Event|Basal Insulin|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with basal insulin.~basal insulin : subcutaneous injection, dosing according to physician's clinical judgment"
910421|NCT01060059|E1|Reported Event|Exenatide|"The targeted population consists of adult patients with type 2 Diabetes Mellitus unable to achieve the desired level of glycemic control while using oral anti-hyperglycemic agents and who initiate treatment with exenatide.~exenatide : subcutaneous injection, 5mcg or 10mcg, twice a day"
910422|NCT01060007|B1|Baseline|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910423|NCT01060007|P1|Participant Flow|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910424|NCT01060007|O3|Outcome|1 Year Post-treatment|
910425|NCT01060007|O2|Outcome|Pre-surgery|
910426|NCT01060007|O1|Outcome|Pre-treatment|
910427|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910428|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910429|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910430|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
911823|NCT01055704|E3|Reported Event|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
923461|NCT01019928|O2|Outcome|Placebo|
910431|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910432|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910475|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
911262|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
910433|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910434|NCT01060007|O1|Outcome|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat every other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910435|NCT01060007|E1|Reported Event|Neoadjuvant Radiation Followed by FOLFOX|"Radiation - 20 Gy in 5 fractions to regional nodes. 25 Gy in the same 5 fractions to macroscopic disease. This is given over 1 week.~FOLFOX Chemotherapy - after two weeks rest - oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV/2 hours followed sequentially by 5FU 400 mg/m2 IV push and 5FU 2400 mg/m2 over 46 hour CIVI. Repeat ever other week for a total of 4 courses (this equals 6 weeks).~If 5-FU is unavailable -- oral capecitabine can be given as 1000 mg/m2 BID on days 1-7 every 14 days."
910436|NCT01059994|B5|Baseline|Total|Total of all reporting groups
910437|NCT01059994|B4|Baseline|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
910438|NCT01059994|B3|Baseline|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
910439|NCT01059994|B2|Baseline|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
910440|NCT01059994|B1|Baseline|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
910441|NCT01059994|P4|Participant Flow|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
910442|NCT01059994|P3|Participant Flow|Sildenafil Placebo Older|Sildenafil placebo: Oral, daily, 1 week.
910443|NCT01059994|P2|Participant Flow|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
910444|NCT01059994|P1|Participant Flow|Sildenafil Placebo Young|Sildenafil placebo: Oral, daily, 1 week.
910445|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
910446|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
910447|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
910448|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
910449|NCT01059994|O4|Outcome|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
910450|NCT01059994|O3|Outcome|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
910451|NCT01059994|O2|Outcome|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
910452|NCT01059994|O1|Outcome|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
910453|NCT01059994|E4|Reported Event|Sildenafil Older|Sildenafil: oral, 25mg, daily for 1 week
910454|NCT01059994|E3|Reported Event|Placebo Sildenafil Older|Sildenafil placebo: Oral, daily, 1 week.
910455|NCT01059994|E2|Reported Event|Sildenafil Young|Sildenafil: oral, 25mg, daily for 1 week
910456|NCT01059994|E1|Reported Event|Placebo Sildenafil Young|Sildenafil placebo: Oral, daily, 1 week.
910457|NCT01059903|B3|Baseline|Total|Total of all reporting groups
910458|NCT01059903|B2|Baseline|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
910459|NCT01059903|B1|Baseline|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
910460|NCT01059903|P2|Participant Flow|Rotigotine PR2.1.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 separated by a washout phase of at least 5 days
910461|NCT01059903|P1|Participant Flow|Rotigotine PR2.2.1 First|Rotigotine transdermal patch 4.5 mg/10cm^2, test drug product PR2.2.1 followed by Rotigotine transdermal patch 4.5 mg/10cm^2, reference drug product PR2.1.1 separated by a washout phase of at least 5 days
910462|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910463|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910464|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910465|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910466|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910467|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
911824|NCT01055704|E2|Reported Event|Codeine 30 mg|
910469|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910470|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910471|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910472|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910473|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910474|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
917663|NCT01035060|O1|Outcome|Older Adults|Age > 70 years
910476|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910477|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910478|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910479|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910480|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910481|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910482|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910483|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910484|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910485|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910486|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910487|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910488|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910489|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910490|NCT01059903|O2|Outcome|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910491|NCT01059903|O1|Outcome|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910492|NCT01059903|E2|Reported Event|Rotigotine PR2.1.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, reference drug product PR2.1.1 ; single application of 1 patch for 24 hours
910493|NCT01059903|E1|Reported Event|Rotigotine PR2.2.1|Rotigotine transdermal patch 4.5 mg/10 cm^2, test drug product PR2.2.1 ; single application of 1 patch for 24 hours
910494|NCT01059864|B1|Baseline|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
910495|NCT01059864|P3|Participant Flow|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910496|NCT01059864|P2|Participant Flow|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910497|NCT01059864|P1|Participant Flow|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
910498|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910499|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910500|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910501|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910502|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
911825|NCT01055704|E1|Reported Event|Methylnaltrexone 0.30 mg/kg|
911826|NCT01055639|B3|Baseline|Total|Total of all reporting groups
910503|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910504|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910505|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910552|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
910506|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910507|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910508|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910509|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910510|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910511|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910512|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910513|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910514|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910515|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910516|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910517|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910518|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910519|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910520|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910521|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910522|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910523|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910747|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
923462|NCT01019928|O1|Outcome|AZD1386 95 mg|
910524|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910525|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910526|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910527|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910528|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910529|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910530|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910531|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910532|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910533|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910534|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910535|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910536|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910537|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910538|NCT01059864|O2|Outcome|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910539|NCT01059864|O1|Outcome|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910540|NCT01059864|E3|Reported Event|CP-690,550 + Placebo|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with placebo matched to atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910541|NCT01059864|E2|Reported Event|CP-690,550 + Atorvastatin|Participants who received CP-690,550 10 mg tablet orally twice daily in open label run-in phase for 6 weeks were randomized to receive CP-690,550 10 mg tablet orally twice daily along with atorvastatin 10 mg tablet orally once daily from Week 6 to 12, during double-blind phase.
910542|NCT01059864|E1|Reported Event|CP-690,550|Participants received CP-690,550 10 milligram (mg) tablet orally twice daily from Week 1 to 6 during open label run-in phase.
910543|NCT01059851|B3|Baseline|Total|Total of all reporting groups
910544|NCT01059851|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
910545|NCT01059851|B1|Baseline|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
910546|NCT01059851|P6|Participant Flow|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910547|NCT01059851|P5|Participant Flow|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910548|NCT01059851|P4|Participant Flow|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910549|NCT01059851|P3|Participant Flow|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910550|NCT01059851|P2|Participant Flow|Healthy Participants (Severe Impairment Controls) (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
910551|NCT01059851|P1|Participant Flow|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
910553|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
910554|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
910555|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
910556|NCT01059851|O4|Outcome|Healthy Participants (Mild Impairment Controls) (Part II)|Healthy participants matched to participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910557|NCT01059851|O3|Outcome|Participants With Mild Renal Impairment (Part II)|Participants with mild renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910558|NCT01059851|O2|Outcome|Healthy Participants (Moderate Impairment Controls) (Part II)|Healthy participants matched to participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910559|NCT01059851|O1|Outcome|Participants With Moderate Renal Impairment (Part II)|Participants with moderate renal impairment were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
910560|NCT01059851|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
910561|NCT01059851|O1|Outcome|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
910562|NCT01059851|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with severe renal impairment received a single dose of 20 mg open-label suvorexant.
910563|NCT01059851|E1|Reported Event|Participants With Severe Renal Impairment (Part I)|"Participants with severe renal impairment received a~single dose of 20 mg open-label suvorexant."
910564|NCT01059812|B3|Baseline|Total|Total of all reporting groups
910565|NCT01059812|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910566|NCT01059812|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910567|NCT01059812|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910568|NCT01059812|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910569|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910570|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910571|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910572|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910573|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910574|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910575|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910576|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910577|NCT01059812|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910578|NCT01059812|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910579|NCT01059812|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910580|NCT01059812|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.
910581|NCT01059799|B3|Baseline|Total|Total of all reporting groups
910582|NCT01059799|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910583|NCT01059799|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
923463|NCT01019928|O2|Outcome|Placebo|
910584|NCT01059799|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910585|NCT01059799|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910586|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910587|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
911263|NCT01057251|O2|Outcome|Placebo|Dose-matched placebo, once daily oral administration
910588|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910589|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910590|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910591|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910592|NCT01059799|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910593|NCT01059799|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910594|NCT01059799|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (under the skin) according to approved labelling in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910595|NCT01059799|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (under the skin) in the evening in combination with pre-trial OADs (except DPP-4 inhibitors) for 26 weeks. Insulin doses were individually adjusted.
910596|NCT01059773|B3|Baseline|Total|Total of all reporting groups
910597|NCT01059773|B2|Baseline|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
910598|NCT01059773|B1|Baseline|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910599|NCT01059773|P2|Participant Flow|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
910600|NCT01059773|P1|Participant Flow|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910601|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
910602|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
910603|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
910604|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
910605|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
910606|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
910607|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
910608|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
910609|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
910610|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
910611|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910612|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910613|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
910614|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
910615|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
917664|NCT01035060|E2|Reported Event|Older Adults|
910616|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910617|NCT01059773|O2|Outcome|UST / MTX Gradually Withdrawn|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. Patients will gradually reduce the dose of methotrexate over the 4 week period after week 0.
910618|NCT01059773|O1|Outcome|UST / MTX Stopped|Patients will receive ustekinumab by SC injection at Weeks 0, 4, 16, 28 and 40. The last dose of methotrexate will be taken anytime in the week prior to baseline (week 0).
910619|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
910620|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
910621|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910622|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910623|NCT01059773|O4|Outcome|UST / MTX Gradually Withdrawn: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy
910624|NCT01059773|O3|Outcome|UST / MTX Gradually Withdrawn: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 2 patients will have gradual reduction of methotrexate therapy.
910625|NCT01059773|O2|Outcome|UST / MTX Stopped: Patients >100kg|Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910626|NCT01059773|O1|Outcome|UST / MTX Stopped: Patients <=100 kg|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910627|NCT01059773|E2|Reported Event|UST / MTX Gradually Withdrawn|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 2 patients will have gradual reduction of methotrexate therapy.
910628|NCT01059773|E1|Reported Event|UST / MTX Stopped|Patients weighing <=100 kg will receive ustekinumab 45 mg (0.5 ml) by SC injection at Weeks 0, 4 and every 12 weeks until Week 40. Patients weighing >100 kg will receive ustekinumab 90 mg (1 ml) in two SC injections. In Arm 1 patients will have immediate cessation of methotrexate therapy.
910629|NCT01059630|B3|Baseline|Total|Total of all reporting groups
910630|NCT01059630|B2|Baseline|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910631|NCT01059630|B1|Baseline|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910632|NCT01059630|P2|Participant Flow|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with complete response (CR), partial response (PR) or stable disease (SD) then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910633|NCT01059630|P1|Participant Flow|Bendamustine Alone|Participants received Bendamustine 120 milligrams per meter square (mg/m^2) Intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910634|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910635|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910692|NCT01059617|B1|Baseline|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910636|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910637|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910696|NCT01059617|P1|Participant Flow|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910638|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910639|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910640|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910641|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910642|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910643|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910644|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910645|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910646|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910647|NCT01059630|O1|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910648|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910649|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910650|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910651|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910652|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910653|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
923464|NCT01019928|O1|Outcome|AZD1386 95 mg|
910654|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910655|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910656|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910657|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910658|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910659|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910660|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910661|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910662|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910663|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910664|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910665|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910666|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910667|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910668|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910669|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910670|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910671|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910693|NCT01059617|P4|Participant Flow|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910748|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
910672|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910673|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910674|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910675|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910676|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910677|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910678|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910679|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910680|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910681|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910682|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910683|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910684|NCT01059630|O2|Outcome|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants with CR, PR, or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910685|NCT01059630|O1|Outcome|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910686|NCT01059630|E2|Reported Event|Obinutuzumab + Bendamustine|"Induction phase: Participants received Bendamustine 90 mg/m^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6.~Maintenance phase: Participants received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first)."
910687|NCT01059630|E1|Reported Event|Bendamustine Alone|Participants received Bendamustine 120 mg/m^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.
910688|NCT01059617|B5|Baseline|Total|Total of all reporting groups
910689|NCT01059617|B4|Baseline|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910690|NCT01059617|B3|Baseline|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910691|NCT01059617|B2|Baseline|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910745|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
912166|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
910694|NCT01059617|P3|Participant Flow|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910695|NCT01059617|P2|Participant Flow|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910916|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
910697|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910698|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910699|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910700|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910701|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910702|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910703|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910704|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910705|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
910706|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
910707|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
910708|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
910709|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910710|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910711|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910712|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910713|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910714|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910715|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910716|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910717|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
910718|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
910719|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
910720|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
910746|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
912167|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
910721|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910722|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910723|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910724|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910725|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910726|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910727|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910728|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910729|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910730|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910731|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910732|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910733|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910734|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910735|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910736|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910737|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910738|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910739|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910740|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910741|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910742|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910743|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910744|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910749|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910750|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910751|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910752|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910753|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910754|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910755|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910756|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910757|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910758|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910759|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910760|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910761|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910762|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910763|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910764|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910765|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910766|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910767|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910768|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910769|NCT01059617|O2|Outcome|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
910770|NCT01059617|O1|Outcome|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
910771|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910772|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910796|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910773|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910774|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910775|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910776|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910777|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910778|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910779|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910780|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day143.
910781|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910782|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm a t Days 0 and 122 and of the dominant arm at Day143.
910783|NCT01059617|O2|Outcome|Placebo Group|Subjects received a saline placebo on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910784|NCT01059617|O1|Outcome|Flulaval Group|Subjects received Flulaval vaccine on Day 0 and either adjuvanted or unadjuvanted formulation of Arepanrix on Days 122 and 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910785|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910786|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910787|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910788|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910789|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910790|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910791|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910792|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910793|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910794|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910795|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910872|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910797|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910798|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910799|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910800|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910801|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910802|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910803|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910804|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910805|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910806|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910807|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910808|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910809|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910810|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910811|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910812|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910813|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910814|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910815|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910816|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910817|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910818|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910819|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910820|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910821|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910822|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910823|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910824|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910825|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910826|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910827|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910828|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910829|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910830|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910831|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910832|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910833|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910834|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910835|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910836|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910837|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910838|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910839|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910840|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910841|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910842|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910843|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910844|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910845|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910846|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910847|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910848|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910849|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910850|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910851|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910852|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910853|NCT01059617|O4|Outcome|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910854|NCT01059617|O3|Outcome|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910855|NCT01059617|O2|Outcome|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910856|NCT01059617|O1|Outcome|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910857|NCT01059617|E6|Reported Event|Placebo Group|subjects from the Placebo/Arepanrix Group and the Placebo/Unadjuvanted Arepanrix Group were pooled.
910858|NCT01059617|E5|Reported Event|Flulaval Group|subjects from the Flulaval/Arepanrix Group and the Flulaval/Unadjuvanted Arepanrix Group were pooled.
910859|NCT01059617|E4|Reported Event|Placebo/Unadjuvanted Arepanrix Group|subjects received a saline placebo on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910860|NCT01059617|E3|Reported Event|Placebo/Arepanrix Group|subjects received a saline placebo on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910861|NCT01059617|E2|Reported Event|Flulaval/Unadjuvanted Arepanrix Group|subjects received Flulaval vaccine on Day 0 and the unadjuvanted formulation of Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910862|NCT01059617|E1|Reported Event|Flulaval/Arepanrix Group|subjects received Flulaval vaccine on Day 0 and Arepanrix vaccine on Day 122 and Day 143. All vaccines were given intramuscularly, in the deltoid region of the non-dominant arm at Days 0 and 122 and of the dominant arm at Day 143.
910863|NCT01059565|B3|Baseline|Total|Total of all reporting groups
910864|NCT01059565|B2|Baseline|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910865|NCT01059565|B1|Baseline|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910866|NCT01059565|P2|Participant Flow|Placebo|Placebo to match AZLI (lactose and sodium chloride) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants switched to AZLI during the open-label phase.
910867|NCT01059565|P1|Participant Flow|AZLI|Aztreonam for inhalation solution (AZLI; 75 mg aztreonam/52.5 mg lysine monohydrate) was administered three times a day, with at least 4 hours between doses, using the investigational nebulizer. After the 24-week randomized phase, participants continued to receive AZLI during the open-label phase.
910868|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910869|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910870|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910871|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
912038|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
910873|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910874|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910875|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910876|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910877|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910878|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910879|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910880|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910881|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910882|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910883|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910884|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910885|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910886|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910887|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910888|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910889|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910890|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910891|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910892|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910893|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910894|NCT01059565|O2|Outcome|Placebo|Placebo to match AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910895|NCT01059565|O1|Outcome|AZLI|AZLI was administered three times a day, with at least 4 hours between doses, for up 48 weeks using the investigational nebulizer.
910896|NCT01059565|E4|Reported Event|Placebo/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline and switched AZLI for up to 24 weeks of treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
910897|NCT01059565|E3|Reported Event|AZLI/AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline and continued to receive an up to an additional 24 weeks of AZLI treatment during the open-label phase, and were analyzed from Week 24 to Week 48.
910898|NCT01059565|E2|Reported Event|Placebo|For the reporting of Adverse Events, this group includes participants who were randomized to receive placebo at baseline, and were analyzed from Baseline to Week 24.
910899|NCT01059565|E1|Reported Event|AZLI|For the reporting of Adverse Events, this group includes participants who were randomized to receive AZLI at baseline, and were analyzed from Baseline to Week 24.
910900|NCT01059526|B3|Baseline|Total|Total of all reporting groups
910901|NCT01059526|B2|Baseline|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
910902|NCT01059526|B1|Baseline|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
910903|NCT01059526|P2|Participant Flow|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
910904|NCT01059526|P1|Participant Flow|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
910905|NCT01059526|O2|Outcome|Patients Non- Naive to KALBITOR|"HAE patients that have been treated with KALBITOR prior to enrollment in the study~ecallantide: 30 mg SC"
910906|NCT01059526|O1|Outcome|Patients Naive to KALBITOR|"HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study~ecallantide: 30 mg SC"
910907|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
910908|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
910909|NCT01059526|O1|Outcome|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
910910|NCT01059526|E1|Reported Event|Safety Population|Safety population; defined as all patients who received at least 1 treatment dose of KALBITOR
910911|NCT01059344|B3|Baseline|Total|Total of all reporting groups
912168|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
910912|NCT01059344|B2|Baseline|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
910913|NCT01059344|B1|Baseline|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
910914|NCT01059344|P2|Participant Flow|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
910915|NCT01059344|P1|Participant Flow|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
910918|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
910919|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
910920|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
910921|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
910922|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
910923|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
910924|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
910925|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
910926|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the placebo treatment group will receive three placebo tablets in the morning and three placebo tablets in the evening.
910927|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets The study drug will be given for 10 weeks. All treatment regimens will be orally administered, with or without food. Subjects randomized to the Asacol™ 4.8 g/day treatment group will receive three 800 mg Asacol™ tablets in the morning and three 800 mg Asacol™ tablets in the evening.
910928|NCT01059344|O2|Outcome|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
910929|NCT01059344|O1|Outcome|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
910930|NCT01059344|E2|Reported Event|Placebo|Placebo to Mesalamin: 4.8g/day, 800 mg tablets
910931|NCT01059344|E1|Reported Event|Mesalamin|Mesalamin: 4.8g/day, 800 mg tablets
910932|NCT01059305|B1|Baseline|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
910933|NCT01059305|P1|Participant Flow|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
910934|NCT01059305|O1|Outcome|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
910935|NCT01059305|E1|Reported Event|Erlotinib|150 mg daily orally before surgery and/or radiation therapy (Induction Treatment); and after surgery and/or radiation erlotinib for up to 1 year (Maintenance Phase).
910936|NCT01059175|B3|Baseline|Total|Total of all reporting groups
910937|NCT01059175|B2|Baseline|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910938|NCT01059175|B1|Baseline|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910939|NCT01059175|P2|Participant Flow|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
911079|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
910940|NCT01059175|P1|Participant Flow|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910941|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910999|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
917665|NCT01035060|E1|Reported Event|Younger Adults|
910942|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910943|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910944|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910945|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910946|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910947|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910948|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910949|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910950|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910951|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910952|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910953|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910954|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910955|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910956|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910957|NCT01059175|O2|Outcome|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910994|NCT01058863|O5|Outcome|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
923465|NCT01019928|E2|Reported Event|Placebo|
910958|NCT01059175|O1|Outcome|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910959|NCT01059175|E2|Reported Event|Standard CRT|"Conventional cardiac resynchronization therapy. Patients in this arm will keep their CRT system unchanged.~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910960|NCT01059175|E1|Reported Event|CRT With Dual Site LV Pacing|"Cardiac resynchronization therapy with the addition of a second LV lead. Positioning of a pacing lead in a cardiac vein should be considered first. An epicardial lead will be used if the implant of an endocardial lead is impossible or previously failed.~Additional Endocardial or Epicardial LV Lead: Addition of a second left ventricular endocardial or epicardial lead~CRT-P or CRT-D: Implantable Cardiac Resynchronization Therapy Pacemaker (CRT-P) or Defibrillator (CRT-D) Device"
910961|NCT01059071|B1|Baseline|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910962|NCT01059071|P4|Participant Flow|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910963|NCT01059071|P3|Participant Flow|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910964|NCT01059071|P2|Participant Flow|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910965|NCT01059071|P1|Participant Flow|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910966|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910967|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910968|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910969|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910970|NCT01059071|O1|Outcome|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910971|NCT01059071|O4|Outcome|Dose Level 4:1500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910972|NCT01059071|O3|Outcome|Dose Level 3:1000 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 3:1000 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910973|NCT01059071|O2|Outcome|Dose Level 2: 750 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 2: 750 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910974|NCT01059071|O1|Outcome|Dose Level 1: 500 mg/m2 PO BID|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
910995|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
910975|NCT01059071|E1|Reported Event|DFMO and Etoposide|"DFMO: Escalating doses of DFMO in a 3 +3 cohort design.~DFMO at current cohort Dose Level orally each day for 21 day cycles~Dose level 1: 500 mg/m2 PO BID Dose level 2: 750 mg/m2 PO BID Dose level 3:1000 mg/m2 PO BID Dose level 4:1500 mg/m2 PO BID~Etoposide: Starting with Cycle 2, etoposide will be given at 50mg/m2/dose PO daily for the first 14 days of each 21 day cycle. Capsules will be rounded to closest 50 mg."
911000|NCT01058863|O4|Outcome|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
911264|NCT01057251|O1|Outcome|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
910976|NCT01058993|B1|Baseline|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
910977|NCT01058993|P1|Participant Flow|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
910978|NCT01058993|O1|Outcome|SINGLE Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
910979|NCT01058993|E1|Reported Event|Single Arm Study, 5 Escalating Doses of AMD3100 (Plerixafor)|Single arm study to examine the hematological effects, pharmacokinetics and safety of plerixafor in patients with myelokathexis attributable to mutations of CXCR4, utilizing serial, escalating doses of plerixafor administered on days 1, 3, 5, 8, and 10. Five intrapatient escalating dose levels, 20 micrograms per kilogram (mcg/kg), 40 micrograms/kilogram(mcg/kg), 80 micrograms/kilogram(mcg/kg), and 240 micrograms/kilogram (mcg/kg)will be examined. The subjects will be patients at the University of Washington General Clinical Research Center for up to 10 days; the study requires subject be available for up to 14 days. Patients will be monitored for hematological effects of plerixafor and observed for adverse effects. If a normal blood neutrophil count is achieved and maintained for at least 24 hours prior to the highest dose, we will stop at that level.
910980|NCT01058941|B3|Baseline|Total|Total of all reporting groups
910981|NCT01058941|B2|Baseline|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910982|NCT01058941|B1|Baseline|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910983|NCT01058941|P2|Participant Flow|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910984|NCT01058941|P1|Participant Flow|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910985|NCT01058941|O2|Outcome|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910986|NCT01058941|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910987|NCT01058941|O2|Outcome|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910988|NCT01058941|O1|Outcome|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910989|NCT01058941|E2|Reported Event|Placebo|"placebo lipoic acid plus placebo oil~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910990|NCT01058941|E1|Reported Event|Lipoic Acid and Omega-3 Fatty Acids|"lipoic acid and fish oil concentrate~lipoic acid and fish oil concentrate: lipic acid (600 milligrams per day) and fish oil concentrate (3 grams per day) for 18 months"
910991|NCT01058863|B1|Baseline|Randomized Treated Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
910992|NCT01058863|P1|Participant Flow|All Randomized Participants|Participants were randomized to one of ten treatment sequences, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
910993|NCT01058863|O1|Outcome|All Randomized Participants|Participants were randomized to one of five treatment arms, which indicated the order of the 5 single-dose treatments administered in this 5-way crossover study.
910996|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
910997|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
910998|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
911001|NCT01058863|O3|Outcome|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
911002|NCT01058863|O2|Outcome|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
911003|NCT01058863|O1|Outcome|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
911004|NCT01058863|E5|Reported Event|Placebo Inhaler|Placebo delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler, and with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
911005|NCT01058863|E4|Reported Event|ProAir® HFA 180 mcg|A single dose of albuterol 180 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
911006|NCT01058863|E3|Reported Event|ProAir® HFA 90 mcg|A single dose of albuterol 90 mcg delivered with ProAir®, a 'press-and-breathe', metered-dose, aerosol inhaler. Placebo inhalers used to maintain the blind.
911007|NCT01058863|E2|Reported Event|Albuterol Spiromax® 180 mcg|A single dose of albuterol 180 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler (2 inhalations). Placebo inhalers used to maintain the blind.
911008|NCT01058863|E1|Reported Event|Albuterol Spiromax® 90 mcg|A single dose of albuterol 90 mcg delivered with Spiromax®, an inhalation-driven, multi-dose dry powder inhaler. Placebo inhalers used to maintain the blind.
911009|NCT01058668|B4|Baseline|Total|Total of all reporting groups
911010|NCT01058668|B3|Baseline|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
911011|NCT01058668|B2|Baseline|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
911012|NCT01058668|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911013|NCT01058668|P3|Participant Flow|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
911014|NCT01058668|P2|Participant Flow|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
911015|NCT01058668|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911016|NCT01058668|O3|Outcome|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
911017|NCT01058668|O2|Outcome|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
911018|NCT01058668|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911019|NCT01058668|O3|Outcome|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
911020|NCT01058668|O2|Outcome|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
911021|NCT01058668|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911022|NCT01058668|E3|Reported Event|Cariprazine (6–12 mg/Day)|Cariprazine 6 mg – 12 mg capsules oral administration, once per day for 3 weeks.
911023|NCT01058668|E2|Reported Event|Cariprazine (3–6 mg/Day)|Cariprazine 3 milligrams (mg) – 6 mg capsules oral administration, once per day for 3 weeks.
911024|NCT01058668|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911025|NCT01058655|B5|Baseline|Total|Total of all reporting groups
911026|NCT01058655|B4|Baseline|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911027|NCT01058655|B3|Baseline|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911028|NCT01058655|B2|Baseline|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911029|NCT01058655|B1|Baseline|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911030|NCT01058655|P4|Participant Flow|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911031|NCT01058655|P3|Participant Flow|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911032|NCT01058655|P2|Participant Flow|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911033|NCT01058655|P1|Participant Flow|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911034|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911035|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
917666|NCT01035047|B3|Baseline|Total|Total of all reporting groups
911036|NCT01058655|O1|Outcome|Phase II: Everolimus 10 mg + Tivozanib 1 mg [Evaluable]|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911037|NCT01058655|O3|Outcome|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911038|NCT01058655|O2|Outcome|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911039|NCT01058655|O1|Outcome|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911040|NCT01058655|O1|Outcome|Phase I: Evaluable|All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
911041|NCT01058655|O1|Outcome|Phase I: Evaluable|All phase I patients received oral everolimus daily continuously and oral tivozanib daily for 3 of a 4 weeks cycle according to the established dose escalation schedule. Patients who withdrew before completing 1 cycle of therapy for reason other than dose-limiting toxicity were not evaluable and replaced.
911042|NCT01058655|E4|Reported Event|Phase II: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911043|NCT01058655|E3|Reported Event|Phase I Cohort 3: Everolimus 10 mg + Tivozanib 1.5 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911044|NCT01058655|E2|Reported Event|Phase I Cohort 2: Everolimus 10 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911045|NCT01058655|E1|Reported Event|Phase I Cohort 1: Everolimus 5 mg + Tivozanib 1 mg|Patients received oral everolimus daily continuously and oral tivozanib daily for 3 of the 4 week cycle. Patients are treated until disease progression, unacceptable toxicity or withdrawal of consent.
911046|NCT01058642|B5|Baseline|Total|Total of all reporting groups
911047|NCT01058642|B4|Baseline|Treatment Sequence 4: ADL5747 Then Placebo|"ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days during 1 of 2 Treatment Periods.~Placebo: Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
911048|NCT01058642|B3|Baseline|Treatment Sequence 3: Placebo Then ADL5747|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~ADL5747: 150 mg BID administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods."
911049|NCT01058642|B2|Baseline|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.~Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
911050|NCT01058642|B1|Baseline|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo: two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2.~Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period."
911051|NCT01058642|P4|Participant Flow|Treatment Sequence 4: ADL5747 Then Placebo|"During Treatment Period 1, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
911052|NCT01058642|P3|Participant Flow|Treatment Sequence 3: Placebo Then ADL5747|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~During Treatment Period 2, ADL5747 150 mg was administered as 1 ADL5747 150-mg capsule and 1 placebo capsule BID for 14 days.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week"
912169|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
911053|NCT01058642|P2|Participant Flow|Treatment Sequence 2: Pregabalin Then Placebo|"Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 1; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID).~At the end of Treatment Period 1 and the start of the first week of the 2-week washout period, participants took a tapered pregabalin dose (75 mg BID) during the first 3 days of the week, followed by placebo orally BID during the last 4 days.~Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 2.~At the end of Treatment Period 2, participants received placebo orally BID for 7 days for the taper week."
911127|NCT01058070|O1|Outcome|LINX Study Subjects|Subjects implanted with LINX device
911054|NCT01058642|P1|Participant Flow|Treatment Sequence 1: Placebo Then Pregabalin|"Placebo was administered orally twice daily (BID) to participants for 14 days during Treatment Period 1.~A two week washout period took place between Treatment Period 1 and Treatment Period 2 where participants were administered placebo orally BID.~Pregabalin 75 mg BID was administered as 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days of Treatment Period 2; the dose was increased to 150 mg BID for the last 11 days of the 2-week treatment period (1 pregabalin 150-mg capsule and 1 placebo capsule BID). This was followed by a dose of pregabalin 75 mg BID (1 pregabalin 75-mg capsule and 1 placebo capsule BID) for 3 days as a taper period followed by placebo orally BID during the last 4 days."
911055|NCT01058642|O3|Outcome|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
911056|NCT01058642|O2|Outcome|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
911057|NCT01058642|O1|Outcome|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
911058|NCT01058642|E3|Reported Event|Pregabalin|Pregabalin: administered orally as a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for the first 3 days, increased to a dose of 1 pregabalin 150-mg capsule and 1 placebo capsule BID for the last 11 days of 1 of 2 fourteen-day Treatment Periods, followed by a dose of 1 pregabalin 75-mg capsule and 1 placebo capsule BID for 3 days as a taper period.
911059|NCT01058642|E2|Reported Event|Placebo|"Two placebo capsules administered orally BID for 14 days during 1 of 2 Treatment Periods.~Participants were also administered placebo orally BID during a 14-day washout period that took place between Treatment Period 1 and Treatment Period 2."
911060|NCT01058642|E1|Reported Event|ADL5747|ADL5747: 150 milligrams (mg) twice daily administered orally as 1 ADL5747 150-mg capsule and 1 placebo capsule twice daily (BID) for 14 days during 1 of 2 Treatment Periods.
911061|NCT01058421|B3|Baseline|Total|Total of all reporting groups
911062|NCT01058421|B2|Baseline|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911063|NCT01058421|B1|Baseline|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911064|NCT01058421|P2|Participant Flow|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911065|NCT01058421|P1|Participant Flow|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911066|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911067|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911068|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911069|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911070|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911071|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911072|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911073|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911074|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911075|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911076|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911077|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911078|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911080|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911081|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911082|NCT01058421|O2|Outcome|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911265|NCT01057251|E2|Reported Event|Placebo|Dose-matched placebo, once daily oral administration
911083|NCT01058421|O1|Outcome|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911084|NCT01058421|E2|Reported Event|Standard of Care Physical Therapy Group|Participants received standard of care inpatient physical therapy 3 days per week, and no outpatient physical therapy, beginning Day 1 through Day 28.
911085|NCT01058421|E1|Reported Event|Intensive Physical Therapy Treatment Group|Participants received intensive physical therapy 7 days per week, and outpatient physical therapy 3 days per week, beginning Day 1 through Day 28.
911086|NCT01058356|B1|Baseline|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
911087|NCT01058356|P1|Participant Flow|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
911088|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
911089|NCT01058356|O1|Outcome|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
911090|NCT01058356|E1|Reported Event|Lacidofil Capsule Versus Placebo Drug|"Lacidofil capsule: Lactobacillus rhamnosus R0011‧Lactobacillus acidophilus R0052 bacterial culture (2x109), maltodextrin, Mg stearate, ascorbic acid (1 capsule twice a day for 14 days) Placebo drug: maltodextrin, Mg stearate, ascorbic acid~(1 capsule twice a day for 14 days)"
911091|NCT01058304|B3|Baseline|Total|Total of all reporting groups
911092|NCT01058304|B2|Baseline|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
911093|NCT01058304|B1|Baseline|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
911094|NCT01058304|P2|Participant Flow|Individual Physical Therapy for Knee OA|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
911095|NCT01058304|P1|Participant Flow|Group Physical Therapy for Knee OA|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
911096|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
911097|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
911121|NCT01058096|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911122|NCT01058096|E2|Reported Event|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
911123|NCT01058096|E1|Reported Event|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911098|NCT01058304|O2|Outcome|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
911266|NCT01057251|E1|Reported Event|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
911099|NCT01058304|O1|Outcome|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
911100|NCT01058304|E2|Reported Event|Arm 2|"Individual Physical Therapy for Knee OA~Individual Physical Therapy for Knee OA: The individual PT arm, modeled after typical PT care for knee OA at the Durham VAMC and other health care settings, will include 2 1-hour visits with a physical therapist, 2-3 weeks apart. While the individual PT sessions will differ in structure from the group PT sessions they will include the same informational, assessment, and therapeutic content as the group sessions. Participants in this group will also be given instructions for the same home exercise program."
911101|NCT01058304|E1|Reported Event|Arm 1|"Group Physical Therapy for Knee OA~Group Physical Therapy for Knee OA: The group PT arm will include 6 1 hour visits (every other week) led by a physical therapist and exercise physiologist or PT Assistant, with 8 participants per group. The group PT sessions will include group instruction in joint care (activity pacing and joint projection), group discussion of exercise successes and barriers, group exercise, and scheduled individual consultations with the physical therapist (2 per participant, 15-20 minutes each) to address specific functional and therapeutic needs. Participants will also be given instructions for a home exercise program."
911102|NCT01058265|B3|Baseline|Total|Total of all reporting groups
911103|NCT01058265|B2|Baseline|Standard|Standard general medical evaluation.
911104|NCT01058265|B1|Baseline|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
911105|NCT01058265|P2|Participant Flow|Standard|Standard general medical evaluation.
911106|NCT01058265|P1|Participant Flow|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
911107|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
911108|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
911109|NCT01058265|O2|Outcome|Standard|Standard general medical evaluation.
911110|NCT01058265|O1|Outcome|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
911111|NCT01058265|E2|Reported Event|Standard|Standard general medical evaluation.
911112|NCT01058265|E1|Reported Event|Integrative|Integrative Medical care is defined as a comprehensive medical evaluation that emphasizes wellness and healing of the whole person as major goals above and beyond suppression of a specific somatic disease. The patient is viewed as a whole person with mind and spirit as well as body and these dimensions are incorporated into diagnosis and treatment plans. An integrative medicine evaluation includes four aspects of health: physical, emotional, mental and spiritual health. Maximum improvement in health is achieved by addressing each aspect through an integrated treatment plan. The evaluation generally takes 90-120 minutes.
911113|NCT01058096|B3|Baseline|Total|Total of all reporting groups
911114|NCT01058096|B2|Baseline|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
911115|NCT01058096|B1|Baseline|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911116|NCT01058096|P2|Participant Flow|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
911117|NCT01058096|P1|Participant Flow|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911118|NCT01058096|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
911119|NCT01058096|O1|Outcome|Placebo|Placebo dose-matching cariprazine capsules oral administration, once per day for 3 weeks.
911120|NCT01058096|O2|Outcome|Cariprazine|Cariprazine 3 mg - 12 mg capsules oral administration, once per day for 3 weeks.
912170|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
911124|NCT01058070|B1|Baseline|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
911125|NCT01058070|P1|Participant Flow|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
911126|NCT01058070|O1|Outcome|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
920561|NCT01028222|P1|Participant Flow|Nilotinib|400 mg twice daily
911128|NCT01058070|E1|Reported Event|Implantable Device|Torax Medical, Inc. LINX Reflux Management System: Implantable device, Magnetic Esophageal Sphincter
911129|NCT01058005|B4|Baseline|Total|Total of all reporting groups
911130|NCT01058005|B3|Baseline|Glatiramer Acetate|20 mg subcutaneous injection once daily
911131|NCT01058005|B2|Baseline|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
911132|NCT01058005|B1|Baseline|Natalizumab|300 mg intravenous injection every 4 weeks
911133|NCT01058005|P3|Participant Flow|Glatiramer Acetate|20 mg subcutaneous injection once daily
911134|NCT01058005|P2|Participant Flow|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
911135|NCT01058005|P1|Participant Flow|Natalizumab|300 mg intravenous injection every 4 weeks
911136|NCT01058005|O3|Outcome|Glatiramer Acetate|20 mg subcutaneous injection once daily
911137|NCT01058005|O2|Outcome|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
911138|NCT01058005|O1|Outcome|Natalizumab|300 mg intravenous injection every 4 weeks
911139|NCT01058005|E3|Reported Event|Glatiramer Acetate|20 mg subcutaneous injection once daily
911140|NCT01058005|E2|Reported Event|Interferon Beta-1a|44 mcg subcutaneous injection 3 times per week
911141|NCT01058005|E1|Reported Event|Natalizumab|300 mg intravenous injection every 4 weeks
911142|NCT01057901|B3|Baseline|Total|Total of all reporting groups
911143|NCT01057901|B2|Baseline|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
911144|NCT01057901|B1|Baseline|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
911145|NCT01057901|P2|Participant Flow|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
911146|NCT01057901|P1|Participant Flow|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
911147|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
911148|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
911149|NCT01057901|O2|Outcome|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
911150|NCT01057901|O1|Outcome|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
911151|NCT01057901|E2|Reported Event|Placebo|"This is the matched placebo which will be administered two tablets daily at bedtime.~Placebo: This is the matched placebo which will be administered two tablets daily at bedtime."
911152|NCT01057901|E1|Reported Event|Flibanserin 100 mg|"Flibanserin 100 mg administered at bedtime~Flibanserin: Flibanserin 100mg administered at bedtime for 24 weeks"
911153|NCT01057888|B4|Baseline|Total|Total of all reporting groups
911154|NCT01057888|B3|Baseline|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
911155|NCT01057888|B2|Baseline|Controls|"Controls~Received standard of care provided by practice"
911156|NCT01057888|B1|Baseline|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
911157|NCT01057888|P3|Participant Flow|Letters|"Mailed reminder letters~Letters : Mailed reminder letters"
911158|NCT01057888|P2|Participant Flow|Controls|"Controls~Received standard of care provided by practice"
911159|NCT01057888|P1|Participant Flow|Autodialer|"Autodialer reminder/recall~Autodialer : Autodialer telephone calls"
911160|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
911161|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
911162|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
911163|NCT01057888|O3|Outcome|Control|Received no reminders from the managed care organization.
911164|NCT01057888|O2|Outcome|Telephone Reminder|Received telephone reminders (through an autodialer)from the managed-care organization for recommended vaccinations
911165|NCT01057888|O1|Outcome|Letter Reminder|Received mailed reminders from the managed-care organization for recommended vaccinations
911166|NCT01057888|E1|Reported Event|Mailed Reminders and Letter Reminders|
911167|NCT01057810|B3|Baseline|Total|Total of all reporting groups
911168|NCT01057810|B2|Baseline|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911169|NCT01057810|B1|Baseline|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911170|NCT01057810|P2|Participant Flow|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911171|NCT01057810|P1|Participant Flow|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911255|NCT01057277|E1|Reported Event|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
911172|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911173|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911174|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911175|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911176|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911177|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911178|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911179|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911180|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911181|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911182|NCT01057810|O2|Outcome|Ipilimumab|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911183|NCT01057810|O1|Outcome|Placebo|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911184|NCT01057810|E2|Reported Event|10 MG/KG IPILIMUMAB|Ipilimumab 10 mg/kg was administered intravenously (IV) over 90 minutes with a normal saline flush at the end. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911185|NCT01057810|E1|Reported Event|PLACEBO|Placebo infusion (normal saline or 5% dextrose) 2mL/kg was administered intravenously (IV) over 90 minutes. Induction dosing occurred on Days 1, 22, 43, and 64 during the Induction phase and every 12 weeks starting at Week 24 during the Maintenance phase until unacceptable toxicity, clinical deterioration, confirmed disease progression, or study closure.
911186|NCT01057693|B1|Baseline|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911187|NCT01057693|P3|Participant Flow|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911188|NCT01057693|P2|Participant Flow|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911189|NCT01057693|P1|Participant Flow|Pregabalin SB|Participants who were inadequately controlled on their current diabetic peripheral neuropathy (DPN) treatment were switched to single-blind (SB) pregabalin capsules at a starting dose of 150 milligram per day (mg/day) and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced greater than or equal to (>=) 30 percent (%) pain reduction from baseline to Week 6 were eligible for double-blind (DB) treatment phase.
923466|NCT01019928|E1|Reported Event|AZD1386 95 mg|
911190|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911256|NCT01057251|B3|Baseline|Total|Total of all reporting groups
920562|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
911191|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911192|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911193|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911194|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911195|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911196|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911197|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911198|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911199|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911200|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911201|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911202|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911203|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911204|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911205|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911206|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911207|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911208|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911209|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911210|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911211|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911212|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911213|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911214|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
926276|NCT01014143|B1|Baseline|Fluoride Toothpaste|negative control
911215|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911216|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911217|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911218|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911219|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911220|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911221|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911222|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911223|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911224|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911225|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911226|NCT01057693|O1|Outcome|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911227|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911228|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911229|NCT01057693|O2|Outcome|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911230|NCT01057693|O1|Outcome|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911231|NCT01057693|E3|Reported Event|Placebo|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received matching placebo capsules, administered three times daily up to Week 19 during DB treatment phase.
911232|NCT01057693|E2|Reported Event|Pregabalin DB|Participants who experienced >=30% pain reduction in SB treatment phase, after Week 6 received pregabalin capsules 150 mg/day or 300 mg/day, administered three times daily up to Week 19 during DB treatment phase.
911233|NCT01057693|E1|Reported Event|Pregabalin SB|Participants who were inadequately controlled on their current DPN treatment were switched to SB pregabalin capsules at a starting dose of 150 mg/day and increased to 300 mg/day, administered three times daily up to Week 6. Participants who experienced >=30% pain reduction from baseline to Week 6 were eligible for DB treatment phase.
911234|NCT01057589|B1|Baseline|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911235|NCT01057589|P1|Participant Flow|Pemetrexed + Cisplatin + Cetuximab|"Pemetrexed 500 milligram per meter squared (mg/m^2) administered by intravenous (IV) infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles.~At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months.~Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements."
911564|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
911257|NCT01057251|B2|Baseline|Placebo|Dose-matched placebo, once daily oral administration
911258|NCT01057251|B1|Baseline|Nebivolol|5 mg, titrated to 20 mg, once daily oral administration
911236|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911237|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911238|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911239|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911240|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911241|NCT01057589|O1|Outcome|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911242|NCT01057589|E1|Reported Event|Pemetrexed Cisplatin Cetuximab|Pemetrexed 500 mg/m^2 administered by IV infusion followed by cisplatin 75 mg/m^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
911243|NCT01057433|B1|Baseline|All Subjects|
911244|NCT01057433|P1|Participant Flow|All Subjects|
911245|NCT01057433|O1|Outcome|All Subjects|
911246|NCT01057433|E1|Reported Event|All Subjects|
911247|NCT01057394|B1|Baseline|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
911248|NCT01057394|P2|Participant Flow|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
911249|NCT01057394|P1|Participant Flow|Radiofrequency Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
911250|NCT01057394|O1|Outcome|Number of Chronically Isolated Pulmonary Veins|
911251|NCT01057394|E1|Reported Event|Visually Guided Ablation|Endoscopically Guided Ablation: Visually Guided Ablation using the EAS-AC Radiofrequency Ablation
911252|NCT01057277|B1|Baseline|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
911253|NCT01057277|P1|Participant Flow|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
911254|NCT01057277|O1|Outcome|RAD001(Afinitor)|"Radiation 47 days Cisplatin day 1,8,15,22,29,36,43 RAD001 Day 1 according to assigned group to day 47~RAD001(Afinitor): Rad001 in combination withCisplatin and Concurrent RT"
911267|NCT01057225|B1|Baseline|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911268|NCT01057225|P6|Participant Flow|Phase II: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911269|NCT01057225|P5|Participant Flow|Phase II: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911270|NCT01057225|P4|Participant Flow|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911271|NCT01057225|P3|Participant Flow|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911272|NCT01057225|P2|Participant Flow|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911273|NCT01057225|P1|Participant Flow|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911274|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911275|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911276|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911277|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911278|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911279|NCT01057225|O4|Outcome|Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911280|NCT01057225|O3|Outcome|Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911281|NCT01057225|O2|Outcome|Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911282|NCT01057225|O1|Outcome|Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15;~Oral 40 mg dexamethasone on days 1, 8, 15, and 22;~Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911283|NCT01057225|O1|Outcome|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911284|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911285|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
938394|NCT00985010|E2|Reported Event|Males|Brain death
911286|NCT01057225|O1|Outcome|Arm I|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911287|NCT01057225|O4|Outcome|Phase I: Dose Level 2|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 45 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911288|NCT01057225|O3|Outcome|Phase I: Dose Level 1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 36 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911289|NCT01057225|O2|Outcome|Phase I: Dose Level 0|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 20 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 27 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911425|NCT01056653|O2|Outcome|Group B Purple|"Four home visits~High Dose: Four home visits"
911290|NCT01057225|O1|Outcome|Phase I: Dose Level -1|"Patients receive:~Oral 300 mg/m^2 cyclophosphamide on days 1, 8, and 15; Oral 40 mg dexamethasone on days 1, 8, 15, and 22; Oral 100 mg thalidomide on days 1-28.~Patients also recieve 15 mg/m^2 carfilzomib IV on days 1, 2, 8, 9, 15, and 16 in cycle 1, and 20 mg/m^2 on days 1, 2, 8, 9, 15, and 16 in subsequent cycles."
911291|NCT01057225|E1|Reported Event|All Treated Patients|Patients receive carfilzomib IV on days 1, 2, 8, 9, 15, and 16; oral cyclophosphamide on days 1, 8, and 15; oral dexamethasone on days 1, 8, 15, and 22; and oral thalidomide on days 1-28.
911292|NCT01057121|B3|Baseline|Total|Total of all reporting groups
911293|NCT01057121|B2|Baseline|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911294|NCT01057121|B1|Baseline|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911295|NCT01057121|P5|Participant Flow|Phase II: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
911296|NCT01057121|P4|Participant Flow|Phase I: Treatment (Lenalidomide), 25 mg/Day|Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
911297|NCT01057121|P3|Participant Flow|Phase I, Treatment Ienalidomide), 20 mg/Day|Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
911298|NCT01057121|P2|Participant Flow|Phase I: Treatment (Lenalidomide), 15 mg/Day|Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
911299|NCT01057121|P1|Participant Flow|Phase I: Treatment (Lenalidomide) , 10 mg/Day|Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
911300|NCT01057121|O2|Outcome|Phase II - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911301|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911302|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911303|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911304|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911305|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911306|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911307|NCT01057121|O5|Outcome|Phase II: 25 m/Day Treatment (Lenalidomide)|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911565|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
911308|NCT01057121|O4|Outcome|Phase I: Treatment (Lenalidomide), 25 mg/Day|"Patients receive 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911309|NCT01057121|O3|Outcome|Phase I - 20 mg/Day Treatment (Lenalidomide)|"Patients receive 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911310|NCT01057121|O2|Outcome|Phase I - 15 mg/Dah Treatment (Lenalidomide)|"Patients receive 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911421|NCT01056653|P3|Participant Flow|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only (at 4 months of age)"
911311|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Treatment (Lenalidomide)|"Patients receive 10 mg/day of lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911312|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911313|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911314|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911315|NCT01057121|O2|Outcome|Phase I - 15 mg/Day Lenalidomide|"Patients received lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911316|NCT01057121|O1|Outcome|Phase I - 10 mg/Day Lenalidomide|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911317|NCT01057121|O5|Outcome|Phase II: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911318|NCT01057121|O4|Outcome|Phase I: 25 mg/Day Lenalidomide|"Patients received 25 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911319|NCT01057121|O3|Outcome|Phase I: 20 mg/Day Lenalidomide|"Patients received 20 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911320|NCT01057121|O2|Outcome|Phase I - 15 mg/Day (Lenalidomide)|"Patients received 15 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911321|NCT01057121|O1|Outcome|Phase I - 10 mg/Day (Lenalidomide)|"Patients received 10 mg/day lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911322|NCT01057121|O1|Outcome|Phase I - Treatment (Lenalidomide)|"Phase I: Patients receive lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles This arm includes patients treated at the 10 mg/day dose (N=3), 15 mg/day dose (N=3), 20 mg/day dose (N=3) and 25 mg/day dose (N=6)"
911323|NCT01057121|E4|Reported Event|Phase I and II: 25 mg/Day Lenalidomide|"Patients receive 25 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911324|NCT01057121|E3|Reported Event|Phase I: 20 mg/Day Lenalidomide|"Patients receive 20 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911325|NCT01057121|E2|Reported Event|Phase I: 15 mg/Day Lenalidomide|"Patients receive 15 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911326|NCT01057121|E1|Reported Event|Phase I: 10 mg/Day Lenalidomide|"Patients receive 10 mg lenalidomide PO once daily on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Lenalidomide: Lenalidomide is administered daily on days 1-21 of a 28-day cycle. The maximum duration of treatment is 12 28-day cycles"
911327|NCT01057017|B1|Baseline|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
911328|NCT01057017|P1|Participant Flow|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
911329|NCT01057017|O1|Outcome|Panitumumab and Bevacizumab|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
911422|NCT01056653|P2|Participant Flow|Group B Purple|"Four home visits~High Dose: Four home visits (at 4, 5, 6, and 7 months of age)"
911423|NCT01056653|P1|Participant Flow|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits (at 4 and 6 months of age)"
911330|NCT01057017|E1|Reported Event|Intervention|"Bevacizumab: 7.5mg/kg, IV over 30-90 minutes every 3 weeks until disease progression.~Panitumumab Dose Level 1: 6mg/kg over 60-120 minutes every 3 weeks until disease progression Dose Level 2: 9mg/kg over 60-120 minutes every 3 weeks until disease progression"
911331|NCT01056913|B1|Baseline|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
911332|NCT01056913|P1|Participant Flow|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
911333|NCT01056913|O1|Outcome|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
911334|NCT01056913|E1|Reported Event|NITI CAR27 (ColonRing)|"Compression Anastomosis Device: Restoring intestinal continuity using the NITI CAR27 device~follow-up colonoscopy: endoscopic exploration of anastomosis after complete healing"
911335|NCT01056822|B3|Baseline|Total|Total of all reporting groups
911336|NCT01056822|B2|Baseline|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911337|NCT01056822|B1|Baseline|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911338|NCT01056822|P2|Participant Flow|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911339|NCT01056822|P1|Participant Flow|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911340|NCT01056822|O1|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911341|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911342|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911343|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911344|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911345|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
938395|NCT00985010|E1|Reported Event|Females|Brain death
911346|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911395|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911424|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
911347|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911348|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911349|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911350|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911351|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911352|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911353|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911354|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911355|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911356|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911357|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911358|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911359|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911392|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911360|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911361|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911362|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911363|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911364|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911365|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911366|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911367|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911368|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911369|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911370|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911371|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911372|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911373|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911393|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911374|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911375|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911376|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911377|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911378|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911379|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911380|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911381|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911382|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911383|NCT01056822|O2|Outcome|Mycophenolate Mofetil (MMF)|Participants were converted to an equimolar dose of Mycophenolate mofetil at baseline visit. Dose of Mycophenolate mofetil was increased at each visit (visits 1 to visit 3) by 180 mg every 12 hours and the tacrolimus or tacrolimus extended release 6 dose was reduced by 25% (to a minimum level of 4 ng/ml). 1 Dosage adjustments allowed the patient to be established and maintained on the maximum tolerated dose of Mycophenolate mofetil (up to a maximum of 720 mg every 12 hours).
911384|NCT01056822|O1|Outcome|Mycophenolate Sodium (MPS)|Participants continued their treatment with MPS according to normal clinical practice, with the dose of MPS increasing at each visit (visit 1 to visit 3) by 250 mg every 12 h and the dose of tacrolimus or tacrolimus extended release (ER) reducing by 25% (to a minimum level of 4 ng/ml).1 The purpose of dosage adjustments was to establish and maintain the patient on the maximum tolerated dose of MPS (up to a maximum of 1 g every 12 h).
911385|NCT01056822|E2|Reported Event|Micofenolato Mofetilo|Micofenolato mofetilo
911386|NCT01056822|E1|Reported Event|Micofenolato Sodium|Micofenolato sodium
911387|NCT01056718|B1|Baseline|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911388|NCT01056718|P1|Participant Flow|Nebivolol Treatment|10 week open label nebivolol treatment.
911389|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911390|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911391|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911566|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
912171|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
911394|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911420|NCT01056653|B1|Baseline|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
911396|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911397|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911398|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911399|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911400|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911401|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911402|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911403|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911404|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911405|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911406|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911407|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911408|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911409|NCT01056718|O1|Outcome|Nebivolol Treatment|"All subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911410|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911411|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911412|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911413|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911414|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911415|NCT01056718|O1|Outcome|Nebivolol Treatment|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
912172|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
911416|NCT01056718|E1|Reported Event|Starting on 5 mg of Nebivolol Then Titrated|"all subjects will begin an initial dosage of 5mg of Nebivolol titrated (doubling of previous dose) to optimal blood pressure below 130/80 at 2 and 4 weeks after treatment initiation.~Nebivolol: Initial dose of 5 mg titrated (doubling of previous dose) to optimal blood pressure."
911417|NCT01056653|B4|Baseline|Total|Total of all reporting groups
911418|NCT01056653|B3|Baseline|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
911419|NCT01056653|B2|Baseline|Group B Purple|"Four home visits~High Dose: Four home visits"
911426|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
911427|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
911428|NCT01056653|O2|Outcome|Group B Purple|"Four intervention home visits~High Dose: Four home visits"
911429|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
911430|NCT01056653|O3|Outcome|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
911431|NCT01056653|O2|Outcome|Group B Purple|"Four intervention home visits~High Dose: Four home visits"
911432|NCT01056653|O1|Outcome|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
911433|NCT01056653|E3|Reported Event|Group C Yellow|"Comparison Group (information only)~Comparison Group: One home visit, information only"
911434|NCT01056653|E2|Reported Event|Group B Purple|"Four home visits~High Dose: Four home visits"
911435|NCT01056653|E1|Reported Event|Group A Teal|"Two intervention home visits~Standard Dose: Two home visits"
911436|NCT01056640|B3|Baseline|Total|Total of all reporting groups
911437|NCT01056640|B2|Baseline|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
911438|NCT01056640|B1|Baseline|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
911439|NCT01056640|P2|Participant Flow|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
911440|NCT01056640|P1|Participant Flow|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
911441|NCT01056640|O2|Outcome|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
911442|NCT01056640|O1|Outcome|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
911523|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
912173|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
911443|NCT01056640|E2|Reported Event|Usual Care|"The usual care intervention will include appropriate primary care and specialty office practice visits as required. It also includes home health care, timely post-hospital outpatient visits, a nurse generated phone call progress report within one business day of hospital dismissal, and standard clinic phone triage during business hours. It also involves a 24 hour nurse triage line for questions. Patients will be informed of the general options currently available to patients including the above as well as options for care in extended hours and at Mayo Express care.~Usual Care : The usual care intervention will include appropriate primary care and specialty office practice visits as required."
911444|NCT01056640|E1|Reported Event|Home Telemonitoring|"The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line. This device has video monitoring which allows a real time face to face interaction with the provider. This allows for an individualized home care plan based upon multiple concerns which have not been adequately studied.~Intel Health Guide : The Intel Health Guide is an FDA approved device that is placed within the patient's home and is connected to the health system via broadband internet, 3G network or phone line."
911574|NCT01056315|B3|Baseline|Total|Total of all reporting groups
911575|NCT01056315|B2|Baseline|Placebo|
911576|NCT01056315|B1|Baseline|GRT3983Y|
911445|NCT01056601|B1|Baseline|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
911446|NCT01056601|P1|Participant Flow|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
911447|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
911448|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
911449|NCT01056601|O1|Outcome|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
911450|NCT01056601|E1|Reported Event|Pancreatic Cancer Patients|Pancreatic cancer patients who received treatment with bortezomib (1.3 mg/m^2 administered intravenously twice daily on days 1 and 8 for 2 weeks followed by 10 day rest period) and panobinostat (20 milligrams administered orally 3 times weekly for 2 weeks on Days 1,3,5,8,10 and 12 followed by 9 day rest period) after progressing on gemcitabine.
911451|NCT01056523|B1|Baseline|Ribavirin and Cytarabine|Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID Drug: Cytarabine arabinoside Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle. Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts.
911452|NCT01056523|P7|Participant Flow|Dose Level 7|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
911453|NCT01056523|P6|Participant Flow|Dose Level 6|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
911454|NCT01056523|P5|Participant Flow|Dose Level 5|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 10 mg sc bid days 1 to 10
911455|NCT01056523|P4|Participant Flow|Dose Level 4|Ribavirin 2200 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
911456|NCT01056523|P3|Participant Flow|Dose Level 3|Ribavirin 1800 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
911457|NCT01056523|P2|Participant Flow|Dose Level 2|Ribavirin 1400 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
911458|NCT01056523|P1|Participant Flow|Dose Level 1|Ribavirin 1000 mg po bid x 28 days, cytarabine arabinoside 20 mg sc bid days 1 to 10
911459|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
911460|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
911461|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
911462|NCT01056523|O1|Outcome|Ribavirin and Cytarabine|Patients with relapsed or refractory AML or elderly untreated AML with FAB subtype M4/M5 or overexpressing eIF4E were treated with ribavirin and cytarabine arabinoside according to a 3+3 dose escalation scheme
911463|NCT01056523|O1|Outcome|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
911464|NCT01056523|E1|Reported Event|Ribavirin-Cytarabine|"Ribavirin: Dose level 1 = 1000 mg po BID/ Dose level 2 = 1400 mg po BID/ Dose level 3 = 1800 mg po BID~Cytarabine arabinoside: Previous cohorts at 20 mg bid days 1 to 10 of every 28 day cycle.~Dosage modified to 10 mg bid days 1 to 10 of every 28 day cycle for more recent cohorts."
911465|NCT01056510|B3|Baseline|Total|Total of all reporting groups
911466|NCT01056510|B2|Baseline|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911467|NCT01056510|B1|Baseline|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911468|NCT01056510|P2|Participant Flow|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered orally (PO) at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until complete response (CR) was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911577|NCT01056315|P2|Participant Flow|Placebo|
911578|NCT01056315|P1|Participant Flow|GRT3983Y|
911579|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911580|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911469|NCT01056510|P1|Participant Flow|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received intravenous (IV) rituximab 375 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced progressive disease (PD).
911470|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911471|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911472|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911473|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911474|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911475|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911476|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911477|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911478|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911479|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911480|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911555|NCT01056341|E2|Reported Event|W24-treatment Period-safety Set-Propranolol 1mg/kg/d 3 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 3 months, then placebo for 3 months
911556|NCT01056341|E1|Reported Event|W24-treatment Period-safety Set-Placebo|Placebo: Treatment with placebo for 6 months
911557|NCT01056328|B3|Baseline|Total|Total of all reporting groups
911481|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911482|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911483|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911484|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911485|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911486|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911487|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911488|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911489|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911490|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911491|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911492|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911493|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911494|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911558|NCT01056328|B2|Baseline|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
911559|NCT01056328|B1|Baseline|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
911560|NCT01056328|P2|Participant Flow|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
911495|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911496|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911497|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911498|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911499|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911500|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911501|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911502|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911503|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911504|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911505|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911506|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911507|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911508|NCT01056510|O2|Outcome|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911561|NCT01056328|P1|Participant Flow|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
911562|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
911563|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
938396|NCT00984867|B3|Baseline|Total|Total of all reporting groups
911509|NCT01056510|O1|Outcome|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911510|NCT01056510|E2|Reported Event|Rituximab + Chlorambucil|Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. Chlorambucil was administered PO at a dose of 10 mg/m^2 on Days 1 to 7, beginning with Cycle 1 and continuing for up to 12 cycles or until CR was achieved. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911511|NCT01056510|E1|Reported Event|Rituximab + Bendamustine|Participants received a specialized first-line or second-line regimen based upon prior chemotherapy exposure. Participants received IV rituximab 375 mg/m^2 on Day 1 of Cycle 1 and 500 mg/m^2 on Day 1 of Cycles 2 to 6. In those requiring a first-line regimen, bendamustine was administered IV at a dose of 90 mg/m^2 on Days 1 and 2 of Cycles 1 to 6. In those requiring a second-line regimen, the bendamustine dose was lowered to 70 mg/m^2. Each cycle was 4 weeks in duration. Treatment was discontinued early in participants who experienced PD.
911512|NCT01056484|B3|Baseline|Total|Total of all reporting groups
911513|NCT01056484|B2|Baseline|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
911514|NCT01056484|B1|Baseline|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
911515|NCT01056484|P2|Participant Flow|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
911516|NCT01056484|P1|Participant Flow|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
911517|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
911518|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
911519|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
911520|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
911521|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
911522|NCT01056484|O1|Outcome|Meditation|Mindfulness Based Relapse Prevention for Alcohol Dependence intervention
911524|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
911525|NCT01056484|O2|Outcome|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
911526|NCT01056484|O1|Outcome|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
911527|NCT01056484|E2|Reported Event|Wait-list Control|"Standard of Care therapy only~Wait-list control: 'Standard of care' (SOC) outpatient therapy for alcohol dependence is provided to all subjects through their outpatient treatment centers and as recommended by their regular providers. Subjects in the control group receive SOC only. Subjects in the experimental arm will receive the study meditation intervention in addition to SOC."
911528|NCT01056484|E1|Reported Event|Meditation|"Mindfulness Based Relapse Prevention intervention + Standard of Care therapy~Mindfulness Based Relapse Prevention for Alcohol Dependence: All study subjects receive outpatient standard of care (SOC) therapy for alcohol dependence. In addition, experimental subjects receive the Mindfulness Meditation Relapse Prevention ('meditation') intervention. This intervention is an extension of existing meditation-based therapies for stress, relapse prevention in addictive disorders, and depression. It has been directly patterned after Mindfulness Based Relapse Prevention and tailored to the specific needs of alcoholics. Its curriculum includes both meditation and traditional cognitive therapy relapse prevention components. The intervention consists of an 8-week, manualized meditation course (2 hours/week group sessions) guided by trained instructors. In addition, experimental subjects are asked to meditate at-home (30 min/day, 6 days/week) during the whole study."
911529|NCT01056341|B6|Baseline|Total|Total of all reporting groups
911530|NCT01056341|B5|Baseline|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
911531|NCT01056341|B4|Baseline|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
911532|NCT01056341|B3|Baseline|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
911533|NCT01056341|B2|Baseline|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
911534|NCT01056341|B1|Baseline|Placebo|Placebo: Treatment with placebo for 6 months
911535|NCT01056341|P5|Participant Flow|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
911536|NCT01056341|P4|Participant Flow|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
911537|NCT01056341|P3|Participant Flow|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
911538|NCT01056341|P2|Participant Flow|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
911539|NCT01056341|P1|Participant Flow|Placebo|Placebo: Treatment with placebo for 6 months
911540|NCT01056341|O2|Outcome|Propranolol 3mg/kg/d 6 Months|Propranolol 3 mg/kg/day for 6 months
911541|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
911542|NCT01056341|O5|Outcome|Propranolol 3 mg/kg/d 6 Months|Propranolol oral solution 3mg/kg/day for 6 months
911543|NCT01056341|O4|Outcome|Propranolol 3 mg/kg/d 3 Months|Propranolol oral solution 3mg/kg/day for 3 months, then placebo for 3 months
911544|NCT01056341|O3|Outcome|Propranolol 1 mg/kg/d 6 Months|Propranolol oral solution 1mg/kg/day for 6 months
911545|NCT01056341|O2|Outcome|Propranolol 1mg/kg/d 3 Months|Propranolol oral solution 1mg/kg/day for 3 months, then placebo for 3 months
911546|NCT01056341|O1|Outcome|Placebo|Placebo: Treatment with placebo for 6 months
911547|NCT01056341|E10|Reported Event|W72-follow-up Period of ex 3mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
911548|NCT01056341|E9|Reported Event|W72-follow-up Period of ex 3mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
911549|NCT01056341|E8|Reported Event|W72-follow-up Period of ex 1mg/kg/d 6 Months Group-safety Set|72-week follow-up period without study treatment administration
911550|NCT01056341|E7|Reported Event|W72-follow-up Period of ex 1mg/kg/d 3 Months Group-safety Set|72-week follow-up period without study treatment administration
911551|NCT01056341|E6|Reported Event|W72-follow-up Period of ex Placebo Group-safety Set|72-week follow-up period without study treatment administration
911552|NCT01056341|E5|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 6 months
911553|NCT01056341|E4|Reported Event|W24-treatment Period-safety Set-Propranolol 3 mg/kg/d 3 Months|Propranolol hydrochloride oral solution 3mg/kg/day for 3 months, then placebo for 3 months
911554|NCT01056341|E3|Reported Event|W24-treatment Period-safety Set-Propranolol 1 mg/kg/d 6 Months|Propranolol hydrochloride oral solution 1mg/kg/day for 6 months
911568|NCT01056328|O2|Outcome|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated Radio Frequency (RF) Ablation System: Irrigated ablation catheter
911569|NCT01056328|O1|Outcome|St Jude Medical (SJM) Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
911570|NCT01056328|O2|Outcome|FDA Approved Open Irriagated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
911571|NCT01056328|O1|Outcome|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
911572|NCT01056328|E2|Reported Event|FDA Approved Open Irrigated RF Ablation System|FDA approved Open Irrigated RF Ablation System: Irrigated ablation catheter
911573|NCT01056328|E1|Reported Event|SJM Cardiac Ablation System|SJM Irrigated Cardiac Ablation System: Irrigated ablation catheter
911581|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911582|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911583|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911584|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911585|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911586|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911587|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911588|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911589|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911590|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911591|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911592|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911593|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911594|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911595|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911596|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911597|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911598|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911599|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911600|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911601|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911602|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911603|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911604|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911605|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911606|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911607|NCT01056315|O2|Outcome|Placebo|Participants randomly assigned to receive placebo.
911608|NCT01056315|O1|Outcome|GRT3983Y|Participants randomly assigned to receive GRT3983Y.
911609|NCT01056315|E2|Reported Event|Placebo|
911610|NCT01056315|E1|Reported Event|GRT3983Y|
911611|NCT01056289|B1|Baseline|Entire Study Population|24 Week Open-label phase DVS SR 50 mg PO QD followed by 4 Week Double-blind phase: DVS SR 50 mg (reference group), DVS SR 25 mg (taper group), or Placebo (abrupt-discontinuation group).
911612|NCT01056289|P4|Participant Flow|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911613|NCT01056289|P3|Participant Flow|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911614|NCT01056289|P2|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
911615|NCT01056289|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine Succinate Sustained-Release Formulation (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 24 Weeks.
911616|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911617|NCT01056289|O2|Outcome|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911618|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
911619|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911620|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911621|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
911622|NCT01056289|O3|Outcome|Placebo|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911623|NCT01056289|O2|Outcome|DVS SR 25 mg|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911624|NCT01056289|O1|Outcome|DVS SR 50 mg|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
911625|NCT01056289|E4|Reported Event|Placebo (Double-blind Phase)|Placebo (abrupt-discontinuation group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet placebo 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911626|NCT01056289|E3|Reported Event|DVS SR 25 mg (Double-blind Phase)|DVS SR 25 mg (taper group): 2 tablets PO QD for 1 week (1 tablet placebo 50 mg and 1 tablet DVS SR 25 mg) then placebo 50 mg 1 tablet PO QD Weeks 2 through 4.
911627|NCT01056289|E2|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg (reference group): 2 tablets PO once daily (QD) for 1 week (1 tablet DVS SR 50 mg and 1 tablet placebo 25 mg) then DVS SR 50 mg 1 tablet PO QD Weeks 2 through 4.
911628|NCT01056289|E1|Reported Event|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 24 Weeks.
911629|NCT01056276|B3|Baseline|Total|Total of all reporting groups
912048|NCT01054885|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
911630|NCT01056276|B2|Baseline|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911631|NCT01056276|B1|Baseline|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911632|NCT01056276|P2|Participant Flow|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911633|NCT01056276|P1|Participant Flow|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911634|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911635|NCT01056276|O1|Outcome|Originl BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911636|NCT01056276|O2|Outcome|BBD Treatment|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911637|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911638|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911639|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911670|NCT01056107|P4|Participant Flow|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911706|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911640|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911641|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911676|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911642|NCT01056276|O2|Outcome|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911643|NCT01056276|O1|Outcome|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911644|NCT01056276|E2|Reported Event|Modified BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria criteria. Patients with stable disease and no intolerable toxicity may continue maintenance therapy with Bortezomib and Dexamethasone every 28 days for 4 cycles. After cycle 4, dexamethasone may be discontinued at the physician's discretion.~Treatment:~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 2 Bortezomib: 1.3 mg/m2 IV Days 1, 8, 15 Dexamethasone: 20 mg orally (PO) Days 1, 2, 8, 9, 15,16~Maintenance:~Bortezomib: 1.3 mg/m2 IV or SQ Days 1, 15 Dexamethasone: 20 mg PO Days 1, 15"
911645|NCT01056276|E1|Reported Event|Original BBD Regimen|"Bendamustine, Bortezomib,and Dexamethasone (BBD) every 28 days for 8 cycles or 2 cycles beyond a confirmed complete response, assessed by International Myeloma Working Group (IMWG) Uniform Response Criteria. No maintenance therapy.~Bendamustine: 80 mg/m2 via intravenous (IV) Days 1 and 4 Bortezomib: 1.3 mg/m2 IV Days 1, 4, 8, 11 Dexamethasone: 40 mg orally (PO) Days 1, 2, 3, 4"
911646|NCT01056263|B1|Baseline|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
911647|NCT01056263|P1|Participant Flow|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
911648|NCT01056263|O1|Outcome|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
911649|NCT01056263|E1|Reported Event|Axitinib|The study is aimed to retrospectively update the overall survival data (5-year) collected from participants who participated to a previous completed axitinib (AG-013736) study (A4061012; NCT00076011). Part of these participants continued axitinib (AG-013736) treatment after study A4061012 closure, under the roll over study (A4061008; NCT00828919).
911650|NCT01056198|B3|Baseline|Total|Total of all reporting groups
911651|NCT01056198|B2|Baseline|Control|Daily gauze and optional sharp debridement
911652|NCT01056198|B1|Baseline|Santyl|2 mm Santyl once daily (QD)
911653|NCT01056198|P2|Participant Flow|Control|Daily gauze and optional sharp debridement
911654|NCT01056198|P1|Participant Flow|Santyl|2 mm Santyl once daily (QD)
911655|NCT01056198|O1|Outcome|Control|Daily gauze and optional sharp debridement
911656|NCT01056198|O1|Outcome|Santyl|2 mm Santyl QD
911657|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
911658|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
911659|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
911660|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
911661|NCT01056198|O2|Outcome|Control|Daily gauze and optional sharp debridement
911662|NCT01056198|O1|Outcome|Santyl|2 mm Santyl once daily (QD)
911663|NCT01056198|E2|Reported Event|Control|Daily gauze and optional sharp debridement
911664|NCT01056198|E1|Reported Event|Santyl|2 mm Santyl once daily (QD)
911665|NCT01056107|B5|Baseline|Total|Total of all reporting groups
911666|NCT01056107|B4|Baseline|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911667|NCT01056107|B3|Baseline|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911668|NCT01056107|B2|Baseline|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911669|NCT01056107|B1|Baseline|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911787|NCT01055704|P3|Participant Flow|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
911671|NCT01056107|P3|Participant Flow|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911672|NCT01056107|P2|Participant Flow|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911673|NCT01056107|P1|Participant Flow|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911674|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911675|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
912049|NCT01054846|B3|Baseline|Total|Total of all reporting groups
911677|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911678|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911679|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911680|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911681|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911682|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911683|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911684|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911685|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911686|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911687|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911688|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911689|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911690|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911691|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911692|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911693|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911694|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911695|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911696|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911697|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911698|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911699|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911700|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911701|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911702|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911703|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911704|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911705|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911707|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911708|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911709|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911710|NCT01056107|O4|Outcome|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911711|NCT01056107|O3|Outcome|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911712|NCT01056107|O2|Outcome|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911713|NCT01056107|O1|Outcome|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911714|NCT01056107|E4|Reported Event|Placebo|Subjects received a matching placebo subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911715|NCT01056107|E3|Reported Event|ROSE-010 300 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 300 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911716|NCT01056107|E2|Reported Event|ROSE-010 100 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 100 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911717|NCT01056107|E1|Reported Event|ROSE-010 30 Mcg|A glucagon-like peptide-1 (GLP-1) analogue. Subjects received a ROSE-010 30 mcg subcutaneous injection daily for 3 consecutive days and on 1 day 2-10 days later.
911718|NCT01056016|B3|Baseline|Total|Total of all reporting groups
911719|NCT01056016|B2|Baseline|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
911720|NCT01056016|B1|Baseline|Wait-list Control|Wait-list control group
911721|NCT01056016|P2|Participant Flow|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to American Academy of Pediatrics (AAP) ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics include the importance of obtaining parent and teacher behavioral ratings at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
911722|NCT01056016|P1|Participant Flow|Wait-list Control|Wait-list control group
911723|NCT01056016|O2|Outcome|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
911724|NCT01056016|O1|Outcome|Wait-list Control|Wait-list control group
911725|NCT01056016|E2|Reported Event|ADHD Collaborative Intervention|"This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial assessment for ADHD and during follow-up after initiating medication treatment and making a DSM-IV based ADHD diagnosis. Practices are given a web-based ADHD portal to assist them in creating a patient registry and to help in obtaining parent and teacher ratings scales. The intervention lasts for 6 months.~ADHD Collaborative: This intervention includes mapping and redesign of office flow to facilitate adherence to AAP ADHD guidelines as well as didactic sessions related to diagnosis and treatment of ADHD. Didactics emphasize the importance of obtaining parent and teacher behavioral ratings (e.g. Vanderbilt ADHD Rating Scales) at the time of the initial"
911726|NCT01056016|E1|Reported Event|Wait-list Control|Wait-list control group
911727|NCT01055886|B3|Baseline|Total|Total of all reporting groups
911728|NCT01055886|B2|Baseline|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
911729|NCT01055886|B1|Baseline|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
911730|NCT01055886|P2|Participant Flow|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
911731|NCT01055886|P1|Participant Flow|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
911732|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
911733|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
911734|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
911735|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
911736|NCT01055886|O2|Outcome|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
911737|NCT01055886|O1|Outcome|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
911738|NCT01055886|E2|Reported Event|Placebo Patch|"placebo patch given pre-quit from weeks 4 through 6~placebo patch: placebo patch used from weeks 4-6"
911739|NCT01055886|E1|Reported Event|Nicotine Patch|"Nicotine patch given pre-quit attempt at weeks 4 through 6~nicotine patch: Nicotine patch, 7-21 mg."
911740|NCT01055834|B3|Baseline|Total|Total of all reporting groups
911741|NCT01055834|B2|Baseline|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone one 3 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B only proceeded to Period III where they received Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast for 3 days. At least a 5 day period passed before post treatment examinations."
911742|NCT01055834|B1|Baseline|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours for 3 days in Period I. After a washout period of 5 or more days, participants were crossed over and received Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours for 3 days in Period II. At least a 5 day period passed before post treatment examinations.
911743|NCT01055834|P2|Participant Flow|Group B: Eszopiclone Three 1 mg Tabs First, Then One 3 mg Tab|"Participants received a single dose of Eszopiclone three 1 mg tablets administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone one 3 mg tablet with water in the morning after fasting for 10 or more hours in Period II.~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations."
911744|NCT01055834|P1|Participant Flow|Group A: Eszopiclone One 3 mg Tab First, Then Three 1mg Tabs|Participants received a single dose of Eszopiclone one 3 mg tablet administered orally with water in the morning after fasting for 10 or more hours in Period I. After a washout period of 5 or more days, participants were crossed over and received a single dose of Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in Period II. At least a 5 day period passed before post treatment examinations.
911745|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.~Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
911746|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group B Period III:~After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations.~Except for the food and drink at breakfast and the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the food and drink at breakfast and the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
911747|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:~Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
911748|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:~Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
911788|NCT01055704|P2|Participant Flow|Codeine 30 mg|
911789|NCT01055704|P1|Participant Flow|Methylnaltrexone 0.30 mg/kg|
911790|NCT01055704|O4|Outcome|Placebo|
911791|NCT01055704|O3|Outcome|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
911792|NCT01055704|O2|Outcome|Codeine 30 mg|
911793|NCT01055704|O1|Outcome|Methylnaltrexone 0.30 mg/kg|
911749|NCT01055834|O2|Outcome|Eszopiclone Three 1 mg Tablets|"Group A Period II, Group B Period I:~Eszopiclone three 1 mg tablets administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
911750|NCT01055834|O1|Outcome|Eszopiclone One 3 mg Tablet|"Group A Period I, Group B Period II:~Eszopiclone one 3 mg tablet administered orally as a single administration with water in the morning after fasting for 10 or more hours.~Except for the water taken with the study drug, participants were not allowed any food or drink (except water) from 10 hours before until 4 hours after administration of the study drug. Except for the water taken with the study drug, participants were not permitted to drink water from 1 hour before until 1 hour after administration of the study drug."
912114|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
911751|NCT01055834|E4|Reported Event|Eszopiclone One 3 mg Tablet (Fasted)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fasted conditions.
911752|NCT01055834|E3|Reported Event|Eszopiclone One 3 mg Tablet (Fed)|After Period II there was at least a 5 day washout period. Certain participants from Group B who were treated in Period II in the bioequivalence study proceeded to Period III (food effect study) where they received a single dose of Eszopiclone one 3 mg tablet taken orally with water, 30 minutes after the start of breakfast. At least a 5 day period passed before post treatment examinations. Adverse Events were collected under fed conditions.
911753|NCT01055834|E2|Reported Event|Eszopiclone Three 1 mg Tablets|Eszopiclone three 1 mg tablets with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
911754|NCT01055834|E1|Reported Event|Eszopiclone One 3 mg Tablet|Eszopiclone one 3 mg tablets administered orally with water in the morning after fasting for 10 or more hours in either first intervention period (Period I) or second intervention period (Period II).
911755|NCT01055782|B3|Baseline|Total|Total of all reporting groups
911756|NCT01055782|B2|Baseline|Without Endoguide|Colonoscopy completed without endoguide
911757|NCT01055782|B1|Baseline|With Endoguide|Colonoscopy completed with endoguide
911758|NCT01055782|P2|Participant Flow|Without Endoguide|Colonoscopy completed without endoguide
911759|NCT01055782|P1|Participant Flow|With Endoguide|Colonoscopy completed with endoguide
911760|NCT01055782|O2|Outcome|Without Endoguide|Colonoscopy completed without endoguide
911761|NCT01055782|O1|Outcome|With Endoguide|Colonoscopy completed with endoguide
911762|NCT01055782|O2|Outcome|Without Endoguide|Exams completed without endoguide. Success rate/completion.
911763|NCT01055782|O1|Outcome|With Endoguide - Success Rate|Exams completed with endoguide. Success rate/completion.
911764|NCT01055782|E2|Reported Event|Without Endoguide|Colonoscopy completed without endoguide
911765|NCT01055782|E1|Reported Event|With Endoguide|Colonoscopy completed with endoguide
911766|NCT01055769|B1|Baseline|Linezolid|Linezolid 600 mg once (oral suspension or tablet) in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911767|NCT01055769|P2|Participant Flow|Linezolid 600 mg Tablet, Then Linezolid 600 mg Oral Suspension|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
911768|NCT01055769|P1|Participant Flow|Linezolid 600 mg Oral Suspension, Then Linezolid 600 mg Tablet|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in first intervention period and Linezolid tablet 600 mg once in morning (at approximately 8:00 AM, after fasting overnight) on Day 1 in second intervention period (after washout period).
911769|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911770|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911771|NCT01055769|O2|Outcome|Linezolid 600mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911772|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911773|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911774|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911775|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911776|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911777|NCT01055769|O2|Outcome|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911778|NCT01055769|O1|Outcome|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911779|NCT01055769|E2|Reported Event|Linezolid 600 mg Tablet|Linezolid tablet 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911780|NCT01055769|E1|Reported Event|Linezolid 600 mg Oral Suspension|Linezolid oral suspension 600 mg once in morning (at approximately 8:00 AM) on Day 1 after fasting overnight.
911781|NCT01055704|B5|Baseline|Total|Total of all reporting groups
911782|NCT01055704|B4|Baseline|Placebo|
911783|NCT01055704|B3|Baseline|Methylnaltrexone 0.30 mg/kg + Codeine 30 mg|
911784|NCT01055704|B2|Baseline|Codeine 30 mg|
911785|NCT01055704|B1|Baseline|Methylnaltrexone 0.30 mg/kg|
911786|NCT01055704|P4|Participant Flow|Placebo|
911827|NCT01055639|B2|Baseline|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911828|NCT01055639|B1|Baseline|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911848|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911829|NCT01055639|P2|Participant Flow|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911830|NCT01055639|P1|Participant Flow|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911831|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911832|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911833|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911834|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911835|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911836|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911837|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911838|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911839|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911840|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911841|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911842|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911843|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911844|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911845|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911846|NCT01055639|O1|Outcome|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911847|NCT01055639|O2|Outcome|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911849|NCT01055639|E2|Reported Event|Telehealth ACT|"8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT). Sessions were delivered via videoconferencing system. ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~Telehealth ACT: 8 individual telehealth sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911850|NCT01055639|E1|Reported Event|In-person ACT|"8 individual in-person sessions of Acceptance and Commitment Therapy (ACT). ACT is a psychotherapy intervention comprised of meditation, goal-setting, and behavior change.~In-Person ACT: 8 individual in-person sessions of Acceptance and Commitment Therapy (ACT): includes mindfulness, values, and committed action"
911851|NCT01055613|B3|Baseline|Total|Total of all reporting groups
911852|NCT01055613|B2|Baseline|ReNu Multi-purpose Solution|Marketed multi-purpose solution (Control Treatment).
911853|NCT01055613|B1|Baseline|Experimental Mutli-purpose Solution|Experimental multi-purpose solution (Test treatment) .
911854|NCT01055613|P2|Participant Flow|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
911855|NCT01055613|P1|Participant Flow|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
911856|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
911857|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
911858|NCT01055613|O2|Outcome|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
911859|NCT01055613|O1|Outcome|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
911860|NCT01055613|E2|Reported Event|ReNu MultiPlus Multi-Purpose Solution|Marketed multi-purpose contact lens care solution (Control Treatment).
911861|NCT01055613|E1|Reported Event|Experimental Multi-purpose Solution|Experimental multi-purpose contact lens care solution (Test treatment)
911862|NCT01055457|B1|Baseline|Dispensed Subjects|All subjects that were dispensed a study lens and solution.
911863|NCT01055457|P10|Participant Flow|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911864|NCT01055457|P9|Participant Flow|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911865|NCT01055457|P8|Participant Flow|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911866|NCT01055457|P7|Participant Flow|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911867|NCT01055457|P6|Participant Flow|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911868|NCT01055457|P5|Participant Flow|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911869|NCT01055457|P4|Participant Flow|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911870|NCT01055457|P3|Participant Flow|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911871|NCT01055457|P2|Participant Flow|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911872|NCT01055457|P1|Participant Flow|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911873|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911874|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911875|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911876|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911877|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911878|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911879|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911880|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911881|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911882|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911883|NCT01055457|O10|Outcome|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911884|NCT01055457|O9|Outcome|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911885|NCT01055457|O8|Outcome|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911886|NCT01055457|O7|Outcome|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911887|NCT01055457|O6|Outcome|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911888|NCT01055457|O5|Outcome|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911889|NCT01055457|O4|Outcome|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911890|NCT01055457|O3|Outcome|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911891|NCT01055457|O2|Outcome|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911892|NCT01055457|O1|Outcome|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911893|NCT01055457|E10|Reported Event|Solution2 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911894|NCT01055457|E9|Reported Event|Solution2 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911895|NCT01055457|E8|Reported Event|Solution2 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911896|NCT01055457|E7|Reported Event|Solution2 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911897|NCT01055457|E6|Reported Event|Solution2 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 2 was ReNu MultiPlus multi-purpose solution.
911898|NCT01055457|E5|Reported Event|Solution1 (Galyfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911899|NCT01055457|E4|Reported Event|Solution1 (Lotrafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911900|NCT01055457|E3|Reported Event|Solution1 (Balafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911901|NCT01055457|E2|Reported Event|Solution1 (Comfilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911902|NCT01055457|E1|Reported Event|Solution1 (Etafilcon A)|Subjects were random first randomized to 1 of 5 contact lenses and then randomized to receive 1 of 2 contact lens solutions. Solution 1 was an experimental multi-purpose solution.
911903|NCT01055262|B1|Baseline|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911904|NCT01055262|P1|Participant Flow|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911905|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911906|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911907|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
912174|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
911908|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911909|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911910|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911911|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911912|NCT01055262|O1|Outcome|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
912115|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
911913|NCT01055262|E1|Reported Event|ThermaCare Overnight HeatWrap|Participants wore 1 heatwrap per day for 5 consecutive days (applied to lower back, worn approximately 8 hours/day while lying in a supine position).
911914|NCT01055223|B1|Baseline|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
911915|NCT01055223|P1|Participant Flow|TZD 6-month Cohort (Including TZD 12-month Cohort)|The study population consisted of type 2 diabetes patients 18-65 years old exposed to thiazolidinedione (TZD). To be eligible for the study, a subject must have had at least one International Classification of Disease (ICD)-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (rosiglitazone [RSG], pioglitazone [PIO], or troglitazone) during their follow-up time available in the database. A subset of patients were followed for at least 12 months (Outcome measure results for this subset also presented). Dose information was not collected.
911916|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
911917|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911918|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911919|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
911920|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days
911921|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911922|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911923|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
911924|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
911925|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911926|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911927|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
911928|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolactone, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
911929|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911930|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911931|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
911932|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into any of the first 3 arms (TZD only, TZD+spironolacton, and TZD+amiloride) during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
912039|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
940876|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
911933|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911934|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911935|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD during their entire follow-up. Dose information was not collected.
911936|NCT01055223|O4|Outcome|Other|Subjects with type 2 diabetes with exposure to TZD, but did not fit into the TZD Alone, TZD+Spironolactone, or TZD+Amiloride treatment groups during their entire follow-up. The prescription days supply for TZD and other drugs must overlap by at least 30 days. Dose information was not collected.
911937|NCT01055223|O3|Outcome|TZD+Amiloride|Subjects with type 2 diabetes who had prescriptions for TZD and amiloride during their entire follow-up. The prescription days supply for TZD and amiloride must overlap by at least 30 days. Dose information was not collected.
911938|NCT01055223|O2|Outcome|TZD+Spironolactone|Subjects with type 2 diabetes who had prescriptions for TZD and spironolactone during their entire follow-up. The prescription days supply for TZD and spirinolactone must overlap by at least 30 days. Dose information was not collected.
911939|NCT01055223|O1|Outcome|TZD Alone|Subjects with type 2 diabetes who had prescriptions for TZD only during their entire follow-up. Dose information was not collected.
911940|NCT01055223|E2|Reported Event|TZD-12 Month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 12 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
911941|NCT01055223|E1|Reported Event|TZD 6-month Cohort|The study population consisted of type 2 diabetes patients 18-65 years old exposed to TZD. To be eligible for the study, a subject must have had at least one ICD-9 code for type 2 diabetes and have at least 6 months of exposure to TZD (RSG, PIO, or troglitazone) during their follow-up time available in the database.
911942|NCT01055197|B3|Baseline|Total|Total of all reporting groups
911943|NCT01055197|B2|Baseline|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
911944|NCT01055197|B1|Baseline|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
911945|NCT01055197|P2|Participant Flow|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
911946|NCT01055197|P1|Participant Flow|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
911947|NCT01055197|O2|Outcome|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
911948|NCT01055197|O1|Outcome|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
911949|NCT01055197|E2|Reported Event|Prophylactic Cranial Irradiation + Consolidation Radiotherapy|Prophylactic Cranial Irradiation (PCI) plus consolidative radiation therapy (RT) to locoregional and residual metastatic disease
911950|NCT01055197|E1|Reported Event|Prophylactic Cranial Irradiation|Prophylactic Cranial Irradiation (PCI)
911951|NCT01055184|B1|Baseline|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
911952|NCT01055184|P1|Participant Flow|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
911953|NCT01055184|O1|Outcome|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
911954|NCT01055184|E1|Reported Event|2009 H1N1 Vaccine|To ensure balance in the age distribution of the study, participants will be stratified by age into two groups: those between 60 and 70 years old, and those older than 70 years of age. All participants will receive the 2009 H1N1 vaccine.
911955|NCT01055171|B3|Baseline|Total|Total of all reporting groups
911956|NCT01055171|B2|Baseline|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
911957|NCT01055171|B1|Baseline|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
911958|NCT01055171|P2|Participant Flow|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
911959|NCT01055171|P1|Participant Flow|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
911960|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
911961|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
911962|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
911963|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
911964|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
911965|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
911966|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
911997|NCT01054911|O1|Outcome|Neoadjuvant Therapy Plus Surgery|Patients received oral therapy for up to 12 weeks and re-evaluated for response. Favorable tumor reduction resulted surgical extirpation typically with less morbid operative intervention.
911967|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
911968|NCT01055171|O2|Outcome|Placebo|"Patient to receive placebo in this condition.~Placebo : 40 mg; Single Dose.~The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2)"
911969|NCT01055171|O1|Outcome|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol : 40 mg; Single Administration.~The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2)."
911970|NCT01055171|E2|Reported Event|Placebo|"Patient to receive placebo in this condition.~Placebo: 40 mg; Single Dose."
911971|NCT01055171|E1|Reported Event|Propranolol|"Patients will receive Propranolol in this condition.~Propranolol: 40 mg; Single Administration."
911972|NCT01055132|B1|Baseline|All Subjects|All subjects who completed the study.
911973|NCT01055132|P2|Participant Flow|Nelfilcon A Toric Lens First/Etafilcon A Toric Lens Second|Nelfilcon A toric contact lens worn daily during first period of 5 - 9 days, then etafilcon A toric contact lens worn daily during second period of 5 - 9 days
911974|NCT01055132|P1|Participant Flow|Etafilcon A Toric Lens First/ Nelfilcon A Toric Lens Second|Etafilcon A toric contact lens worn daily during first period of 5 - 9 days, then nelfilcon A toric contact lens worn daily during second period of 5 - 9 days
911975|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days.
911976|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
911977|NCT01055132|O2|Outcome|Nelfilcon A (Active Comparator)|An existing, daily disposable toric contact lens; worn for 5-9 days
911978|NCT01055132|O1|Outcome|Etafilcon A (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn 5-9 days
911979|NCT01055132|O2|Outcome|Nelfilcon A Toric Lens (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
911980|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
911981|NCT01055132|O2|Outcome|Nelfilcon A Toric (Active Comparator)|An existing, daily disposable toric contact lens; worn 5-9 days
911982|NCT01055132|O1|Outcome|Etafilcon A Toric (Test Lens)|Etafilcon A toric is a daily disposable hydrogel toric lens with the addition of a wetting agent, developed for a wider ranged of prescriptions; worn for 5-9 days
911983|NCT01055132|E1|Reported Event|Etafilcon A Toric / Nelfilcon A Toric|etafilcon A toric contact lens worn daily during first period of a maximum of 9 days, nelfilcon A toric contact lens worn during second period of a maximum of 9 days
911984|NCT01054976|B1|Baseline|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911985|NCT01054976|P1|Participant Flow|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911986|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911987|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911988|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911989|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911990|NCT01054976|O1|Outcome|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911991|NCT01054976|E1|Reported Event|Galantamine|8 mg/day for 4 weeks; 16 mg/day thereafter
911992|NCT01054911|B1|Baseline|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
911993|NCT01054911|P1|Participant Flow|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
911994|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
911995|NCT01054911|O1|Outcome|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
911996|NCT01054911|O2|Outcome|Neoadjuvant Therapy no Surgery|Patients received oral therapy for up to 12 weeks. Reassessment demonstrated response, but no surgical intervention
911998|NCT01054911|E1|Reported Event|Sunitinib Pill|"Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16.~Sunitinib: All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.~Surgery: Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16."
911999|NCT01054885|B7|Baseline|Total|Total of all reporting groups
912000|NCT01054885|B6|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912001|NCT01054885|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912002|NCT01054885|B4|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912003|NCT01054885|B3|Baseline|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912004|NCT01054885|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912005|NCT01054885|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912006|NCT01054885|P7|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912007|NCT01054885|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912008|NCT01054885|P5|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
912009|NCT01054885|P4|Participant Flow|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912010|NCT01054885|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
912011|NCT01054885|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
912012|NCT01054885|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
912013|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912014|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912015|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912016|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912017|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912018|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912019|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912020|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912021|NCT01054885|O4|Outcome|FVI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912022|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912023|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912024|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912025|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912026|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912027|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912028|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912029|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912030|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912031|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912032|NCT01054885|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912033|NCT01054885|O4|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912034|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912035|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912036|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912037|NCT01054885|O6|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912040|NCT01054885|O3|Outcome|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912041|NCT01054885|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912042|NCT01054885|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912043|NCT01054885|E6|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg OD in the morning from the DPI for 24 weeks.
912044|NCT01054885|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912045|NCT01054885|E4|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912046|NCT01054885|E3|Reported Event|FF 200 µg OD|Participants received FF 200 µg OD in the morning from the DPI for 24 weeks.
912047|NCT01054885|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
920563|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
912050|NCT01054846|B2|Baseline|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
912051|NCT01054846|B1|Baseline|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
912052|NCT01054846|P2|Participant Flow|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
912053|NCT01054846|P1|Participant Flow|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
912054|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
912055|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
912056|NCT01054846|O2|Outcome|Helmet Education|"Each child did not receive a bicycle Bell helmet but the child and his/her caregiver was given bicycle helmet education package as above.~Bicycle helmet education only: As described under the respective arm"
912057|NCT01054846|O1|Outcome|Helmet and Helmet Education|"Each participant preschool child received a free bicycle Bell helmet, manufactured by Bell Sports Inc., Rantoul IL, USA. In addition, classroom bicycle helmet education was provided to all participant children and their caregivers, consisting of a video on rules of biking and the importance of proper helmet use and a classroom melon drop demonstration with and without a helmet to participants and their caregivers.~Bicycle helmet from Bell Sports Inc.: As described under the respective arm"
912058|NCT01054846|E1|Reported Event|All Study Participants|
912059|NCT01054820|B1|Baseline|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912060|NCT01054820|P1|Participant Flow|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912061|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912062|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912063|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912064|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912065|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912104|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912105|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912066|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912067|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912068|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912116|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912117|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912069|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912070|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912071|NCT01054820|O1|Outcome|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912072|NCT01054820|E1|Reported Event|FLECTOR® Patch (Diclofenac Epolamine Topical Patch) 1.3%.|One patch applied topically every 12 hours for up to 14 days. Patch was to be applied at approximately the same time every day upon arising in the morning and at bedtime. The patch was to be applied to the most painful area to cover as much of the painful region as possible.
912073|NCT01054742|B1|Baseline|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
912074|NCT01054742|P1|Participant Flow|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
912075|NCT01054742|O1|Outcome|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
912076|NCT01054742|E1|Reported Event|Standard of Care PegIntron Plus Ribavirin [Part 2]|Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribivirin for 48 weeks.
912077|NCT01054729|B5|Baseline|Total|Total of all reporting groups
912078|NCT01054729|B4|Baseline|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
912079|NCT01054729|B3|Baseline|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912080|NCT01054729|B2|Baseline|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912081|NCT01054729|B1|Baseline|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912082|NCT01054729|P4|Participant Flow|Placebo+PEG+RBV|Participants received placebo to match sofosbuvir for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
912083|NCT01054729|P3|Participant Flow|Sofosbuvir 400 mg+PEG+RBV|Participants received sofosbuvir 400 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
912084|NCT01054729|P2|Participant Flow|Sofosbuvir 200 mg+PEG+RBV|Participants received sofosbuvir 200 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
912085|NCT01054729|P1|Participant Flow|Sofosbuvir 100 mg+PEG+RBV|Participants received sofosbuvir 100 mg for 28 days (baseline to Day 28), plus PEG+RBV (baseline to Week 48)
912086|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912087|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912088|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912089|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912090|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912091|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912092|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912093|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912094|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912095|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912096|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912097|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912098|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912099|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912100|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912101|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912102|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912103|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912106|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912107|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912108|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912109|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912110|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912111|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912112|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912113|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912118|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912119|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912120|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912121|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912122|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912123|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912124|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912125|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
912126|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912127|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912128|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912129|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
912130|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912131|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912132|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912133|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
912134|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912135|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912136|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912137|NCT01054729|O4|Outcome|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
912138|NCT01054729|O3|Outcome|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912139|NCT01054729|O2|Outcome|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912140|NCT01054729|O1|Outcome|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912141|NCT01054729|E4|Reported Event|Placebo+PEG+RBV|Placebo to match sofosbuvir for 28 days plus PEG+RBV for 48 weeks
912142|NCT01054729|E3|Reported Event|Sofosbuvir 400 mg+PEG+RBV|Sofosbuvir 400 mg for 28 days plus PEG+RBV for 48 weeks
912143|NCT01054729|E2|Reported Event|Sofosbuvir 200 mg+PEG+RBV|Sofosbuvir 200 mg for 28 days plus PEG+RBV for 48 weeks
912144|NCT01054729|E1|Reported Event|Sofosbuvir 100 mg+PEG+RBV|Sofosbuvir 100 mg for 28 days plus PEG+RBV for 48 weeks
912145|NCT01054703|B1|Baseline|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
912146|NCT01054703|P1|Participant Flow|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
912147|NCT01054703|O1|Outcome|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
912148|NCT01054703|E1|Reported Event|Ethmoid Sinus Spacer Placement|Ethmoid Sinus Spacer and Access System used for the local delivery of Kenalog-40
912149|NCT01054625|B4|Baseline|Total|Total of all reporting groups
912150|NCT01054625|B3|Baseline|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
912151|NCT01054625|B2|Baseline|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
912152|NCT01054625|B1|Baseline|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
912153|NCT01054625|P3|Participant Flow|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
912154|NCT01054625|P2|Participant Flow|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
912155|NCT01054625|P1|Participant Flow|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
912156|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
912157|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
912158|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
912159|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
912160|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
912161|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
912162|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
912163|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
912164|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
912165|NCT01054625|O3|Outcome|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
912175|NCT01054625|O2|Outcome|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
912176|NCT01054625|O1|Outcome|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
912177|NCT01054625|E3|Reported Event|Zalutumumab 16 mg/kg|zalutumumab 16 mg/kg iv infusion
912178|NCT01054625|E2|Reported Event|Zalutumumab 8 mg/kg|zalutumumab 8 mg/kg iv infusion
912179|NCT01054625|E1|Reported Event|Zalutumumab 4 mg/kg|zalutumumab 4 mg/kg iv infusion
912180|NCT01054586|B5|Baseline|Total|Total of all reporting groups
912181|NCT01054586|B4|Baseline|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912182|NCT01054586|B3|Baseline|FPV, Other|All other dosages of Fosamprenavir
912183|NCT01054586|B2|Baseline|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912184|NCT01054586|B1|Baseline|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912185|NCT01054586|P4|Participant Flow|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912186|NCT01054586|P3|Participant Flow|FPV, Other|All other dosages of FPV (excluding FPV 700 mg BID/RTV 100 mg BID and FPV 700 mg BID/RTV 100 mg QD)
912187|NCT01054586|P2|Participant Flow|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912254|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912188|NCT01054586|P1|Participant Flow|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912189|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912190|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912191|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
912192|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
912193|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912194|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912195|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
912196|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
912197|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
912198|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
912199|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912200|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912201|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
912202|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912203|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912204|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912205|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
912206|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912207|NCT01054586|O1|Outcome|All Participants|All Participants, across all arms
912208|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912209|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912210|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912211|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912212|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
912213|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912214|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912215|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912216|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
912217|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912218|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912219|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912220|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
912221|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912222|NCT01054586|O2|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912223|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912224|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912225|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912226|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
912227|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
912228|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912229|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912230|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
912231|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
912232|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912233|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912234|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
912235|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
912236|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912237|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912238|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
912239|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 mg BID/Ritonavir 100 mg BID
912240|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912241|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912242|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg QD
912243|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|
912244|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir, Standard Dose
912245|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912246|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|Fosamprenavir 700 mg BID/Ritonavir 100 mg once a day (QD)
912247|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912248|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912249|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912250|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912251|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912252|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912253|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912255|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912256|NCT01054586|O4|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912257|NCT01054586|O3|Outcome|FPV, Other|All other dosages of Fosamprenavir
912258|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912259|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912260|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912261|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912262|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912263|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912264|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912265|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912266|NCT01054586|O3|Outcome|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912267|NCT01054586|O2|Outcome|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912268|NCT01054586|O1|Outcome|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912269|NCT01054586|O2|Outcome|Not ART naïve|Patients who have previously been exposed to ART therapy
912270|NCT01054586|O1|Outcome|ART naïve|Patients that have never been exposed (termed naive) to Antiretroviral (ART) therapy
912271|NCT01054586|E4|Reported Event|LPV, Standard Dose|Lopinavir (LPV), Standard Dose
912272|NCT01054586|E3|Reported Event|FPV, Other|All other dosages of Fosamprenavir
912273|NCT01054586|E2|Reported Event|FPV 700 mg BID/RTV 100 mg QD|FPV 700 mg BID/RTV 100 mg once a day (QD)
912274|NCT01054586|E1|Reported Event|FPV 700 mg BID/RTV 100 mg BID|Fosamprenavir 700 milligrams (mg) twice a day (BID)/Ritonavir 100 mg BID
912275|NCT01054573|B5|Baseline|Total|Total of all reporting groups
912276|NCT01054573|B4|Baseline|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912277|NCT01054573|B3|Baseline|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912278|NCT01054573|B2|Baseline|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912279|NCT01054573|B1|Baseline|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912280|NCT01054573|P4|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912281|NCT01054573|P3|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912282|NCT01054573|P2|Participant Flow|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912283|NCT01054573|P1|Participant Flow|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912365|NCT01054339|P2|Participant Flow|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
912284|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 8, 7, and 7, respectively.
912285|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 26, 26, 26, 24, 23, and 21, respectively.
912286|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 20, 19, and 16, respectively.
912372|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
912287|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 31, 23, 18, and 15, respectively.
912288|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 9, 9, 9, 9, 9, 8, 7, and 7, respectively.
912289|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 27, 26, 26, 26, 24, 23, and 21, respectively.
912290|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 22, 22, 22, 22, 20, 19, and 16, respectively.
912291|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders. The number of participants analyzed at Baseline and Weeks 4, 8, 12, 24, 36, and 48 were: 32, 32, 32, 31, 23, 18, and 16, respectively.
912292|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912293|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912294|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912295|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912296|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912297|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912298|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912299|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912300|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912366|NCT01054339|P1|Participant Flow|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
912301|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912302|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912303|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912472|NCT01053988|B2|Baseline|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912304|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912305|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912306|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912307|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912308|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912309|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912310|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912311|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912312|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912313|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912314|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912315|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912316|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912317|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912318|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912319|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
913014|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
912320|NCT01054573|O4|Outcome|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912321|NCT01054573|O3|Outcome|Phase 3: T12(Q8h)/PR - Prior Relapser|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior relapsers.
912322|NCT01054573|O2|Outcome|Phase 3: T12(Q8h)/PR - Prior Partial Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy for virologic reasons and were categorized as prior partial responders.
912473|NCT01053988|B1|Baseline|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912323|NCT01054573|O1|Outcome|Phase 3: T12(Q8h)/PR - Prior Null Responder|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216 (NCT00703118) control group who failed prior therapy due to virologic reasons and were categorized as prior null responders.
912324|NCT01054573|E2|Reported Event|Phase 3: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 3 Study VX-950-TiDP24-C216(NCT00703118) control group who failed prior therapy due to virologic reasons (ncludes all participants, ie, those categorized as prior null responders, prior partial responders, and prior relapsers).
912325|NCT01054573|E1|Reported Event|Phase 1: T12(Q8h)/PR|T12(Q8)/PR=Telaprevir every 8 hours for 12 weeks in combination with pegylated interferon (Peg-IFN) alfa-2a + ribavirin (RBV) administered for 48 weeks to participants who rolled-over from Phase 1 Studies VX04-950-101 or VX05-950-103.
912326|NCT01054560|B3|Baseline|Total|Total of all reporting groups
912327|NCT01054560|B2|Baseline|MERCI® Device|The MERCI® Device (control device) is commercially available.
912328|NCT01054560|B1|Baseline|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912329|NCT01054560|P2|Participant Flow|MERCI® Device|The MERCI® Device (control device) is commercially available.
912330|NCT01054560|P1|Participant Flow|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912331|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
912332|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
912333|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
912334|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
912335|NCT01054560|O2|Outcome|MERCI® Device|MERCI® Device (control device) is commercially available.
912336|NCT01054560|O1|Outcome|SOLITAIRE™ Device|SOLITAIRE™ Device (investigational device) is the experimental arm
912337|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
912338|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912339|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
912340|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912341|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
912342|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912343|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
912344|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912345|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
912346|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912347|NCT01054560|O2|Outcome|MERCI® Device|The MERCI® Device (control device) is commercially available.
912348|NCT01054560|O1|Outcome|SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912349|NCT01054560|E2|Reported Event|The MERCI® Device|The MERCI® Device (control device) is commercially available.
912350|NCT01054560|E1|Reported Event|The SOLITAIRE™ Device|The SOLITAIRE™ Device (investigational device) is the experimental arm
912351|NCT01054404|B3|Baseline|Total|Total of all reporting groups
912352|NCT01054404|B2|Baseline|Placebo|Placebo : Placebo (up to 5mL)
912353|NCT01054404|B1|Baseline|Furosemide|Furosemide : Furosemide 0.3 mg/kg
912354|NCT01054404|P2|Participant Flow|Placebo|Placebo : Placebo (up to 5mL)
912355|NCT01054404|P1|Participant Flow|Furosemide|Furosemide : Furosemide 0.3 mg/kg
912356|NCT01054404|O2|Outcome|Placebo|Placebo : Placebo (up to 5mL)
912357|NCT01054404|O1|Outcome|Furosemide|Furosemide : Furosemide 0.3 mg/kg
912358|NCT01054404|E2|Reported Event|Placebo|Placebo : Placebo (up to 5mL)
912359|NCT01054404|E1|Reported Event|Furosemide|Furosemide : Furosemide 0.3 mg/kg
912360|NCT01054339|B4|Baseline|Total|Total of all reporting groups
912361|NCT01054339|B3|Baseline|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
912362|NCT01054339|B2|Baseline|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
912363|NCT01054339|B1|Baseline|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
912364|NCT01054339|P3|Participant Flow|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
913015|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
912367|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
912368|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
912369|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
912370|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
912371|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
914253|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
912373|NCT01054339|O3|Outcome|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
912374|NCT01054339|O2|Outcome|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
912375|NCT01054339|O1|Outcome|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
912376|NCT01054339|E3|Reported Event|High Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e12 vg/kg administered as 10 IM injections in each arm and 10 IM injections in each of four sites in each leg (total of 100 injections)
912377|NCT01054339|E2|Reported Event|Middle Dose|rAAV1-CB-hAAT at dosage level of 1.9 x 10e12 vg/kg administered as 10 IM injections in one arm and 11 IM injections in each leg (total of 32 injections)
912378|NCT01054339|E1|Reported Event|Low Dose|rAAV1-CB-hAAT at dosage level of 6 x 10e11 vg/kg administered as 10 IM injections in one arm
912379|NCT01054222|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912380|NCT01054222|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912381|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912382|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912383|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912384|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912385|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912386|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912387|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912388|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912389|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912390|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912391|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912392|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912393|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912394|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912395|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912396|NCT01054222|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912397|NCT01054222|E1|Reported Event|Fesoterodine|Fesoterodine 4 milligram (mg) or 8 mg tablet orally once daily according to previous regime received in study A0221045 (NCT00798434).
912398|NCT01054183|B3|Baseline|Total|Total of all reporting groups
912399|NCT01054183|B2|Baseline|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
912400|NCT01054183|B1|Baseline|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
912401|NCT01054183|P2|Participant Flow|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
912402|NCT01054183|P1|Participant Flow|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
912403|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
912404|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
912405|NCT01054183|O2|Outcome|Direct Laryngoscopy Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team B. Team B will do intubations using direct laryngoscopy only that day.~Direct Laryngoscopy : Intubations will be done with direct laryngoscopy."
912474|NCT01053988|P6|Participant Flow|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912406|NCT01054183|O1|Outcome|GlideScope Ranger Intubation|"The study site has two critical care transport teams per shift and will, at shift change, assign intubation team A to use the GlideScope Ranger for all intubations on that day.~GlideScope Ranger Intubation : Intubation with GlideScope Ranger Video Laryngoscope"
912407|NCT01054183|E2|Reported Event|Direct Laryngoscopy|Procedure used to visualize the vocal cords and perform tracheal intubation in the pediatric and neonatal population.
912408|NCT01054183|E1|Reported Event|GlideScope Video Laryngoscope Ranger(GVL)|Procedure used to perform tracheal intubation that facilitates indirect visualization of the glottis through a video display.
912409|NCT01054170|B3|Baseline|Total|Total of all reporting groups
912410|NCT01054170|B2|Baseline|Placebo|Placebo 2 tablets bid
912411|NCT01054170|B1|Baseline|AZD9668|AZD9668 2x30mg bid
912412|NCT01054170|P2|Participant Flow|Placebo|Placebo 2 tablets bid
912413|NCT01054170|P1|Participant Flow|AZD9668|AZD9668 2x30mg bid
912414|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912415|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912416|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912417|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912418|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912419|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912420|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912421|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912422|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912423|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912424|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912425|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912426|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912427|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912428|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912429|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912430|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912431|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912432|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912433|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912434|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912435|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912436|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912437|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912438|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912439|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912440|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912441|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912442|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912443|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912444|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912445|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912446|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912447|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912448|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912449|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912450|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912451|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912452|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912453|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912454|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912455|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912456|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912457|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912458|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912459|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912460|NCT01054170|O2|Outcome|Placebo|Placebo 2 tablets bid
912461|NCT01054170|O1|Outcome|AZD9668|AZD9668 2x30mg bid
912462|NCT01054170|E2|Reported Event|Placebo|Placebo 2 tablets bid
912463|NCT01054170|E1|Reported Event|AZD9668|AZD9668 2x30mg bid
912464|NCT01054079|B1|Baseline|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
912465|NCT01054079|P1|Participant Flow|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
912466|NCT01054079|O1|Outcome|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
912520|NCT01053897|O1|Outcome|GBT009|All subjects acted as their own control receiving both GBT009 and Placebo
913016|NCT01051817|E2|Reported Event|AIN457 10mg/kg|AIN457 10mg/kg
912467|NCT01054079|E1|Reported Event|Treatment (Cinacalcet Hydrochloride)|"Patients receive cinacalcet hydrochloride PO QD for 20 weeks in the absence of disease progression or unacceptable toxicity.~laboratory biomarker analysis: Correlative study~quality-of-life assessment: Ancillary study~questionnaire administration: Ancillary study~cinacalcet hydrochloride: Given PO"
912468|NCT01053988|B6|Baseline|Total|Total of all reporting groups
912469|NCT01053988|B5|Baseline|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912470|NCT01053988|B4|Baseline|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912471|NCT01053988|B3|Baseline|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912475|NCT01053988|P5|Participant Flow|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912476|NCT01053988|P4|Participant Flow|VI 25 µg OD|Participants received Vilanterol (VI [GW642444]) 25 µg OD in the morning from the DPI for 24 weeks.
912477|NCT01053988|P3|Participant Flow|FF 100 µg OD|Participants received Fluticasone Furoate (FF) 100 micrograms (µg) OD in the morning from the DPI for 24 weeks.
912478|NCT01053988|P2|Participant Flow|Placebo|Participants received placebo once daily (OD) in the morning from the dry powder inhaler (DPI) for 24 weeks.
912479|NCT01053988|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning for 2 weeks.
912480|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912481|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912482|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912483|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912484|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912485|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912486|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912487|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912488|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912489|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912490|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912491|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912492|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912493|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912494|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912495|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912496|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912497|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912498|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912499|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912500|NCT01053988|O5|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912501|NCT01053988|O4|Outcome|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912502|NCT01053988|O3|Outcome|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912503|NCT01053988|O2|Outcome|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912504|NCT01053988|O1|Outcome|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912505|NCT01053988|E5|Reported Event|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg OD in the morning from the DPI for 24 weeks.
912506|NCT01053988|E4|Reported Event|FF/VI 50/25 µg OD|Participants received FF/VI 50/25 µg OD in the morning from the DPI for 24 weeks.
912507|NCT01053988|E3|Reported Event|VI 25 µg OD|Participants received VI 25 µg OD in the morning from the DPI for 24 weeks.
912508|NCT01053988|E2|Reported Event|FF 100 µg OD|Participants received FF 100 µg OD in the morning from the DPI for 24 weeks.
912509|NCT01053988|E1|Reported Event|Placebo|Participants received placebo OD in the morning from the DPI for 24 weeks.
912510|NCT01053897|B1|Baseline|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
912511|NCT01053897|P1|Participant Flow|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
912512|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
912513|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
912514|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment
912515|NCT01053897|O1|Outcome|GBT009|Therapy treated scar segment
912516|NCT01053897|O3|Outcome|No Difference|No scar segment was preferred to the other
912517|NCT01053897|O2|Outcome|Placebo|Placebo treated scar segment preferred
912518|NCT01053897|O1|Outcome|GBT009|GBT009 treated scar segment preferred
912519|NCT01053897|O2|Outcome|Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
912521|NCT01053897|E1|Reported Event|GBT009/Placebo|All subjects acted as their own control receiving both GBT009 and Placebo
912522|NCT01053819|B1|Baseline|Etanercept|open label treatment per FDA approval for 24 weeks
912523|NCT01053819|P1|Participant Flow|Etanercept|Patients will receive six months of treatment with Enbrel 50mg SC given twice a week for the first three months and 50 mg once a week thereafter.
912524|NCT01053819|O1|Outcome|Etanercept|open label treatment per FDA approval for 24 weeks
912525|NCT01053819|E1|Reported Event|Etanercept|open label treatment per FDA approval for 24 weeks
912526|NCT01053741|B3|Baseline|Total|Total of all reporting groups
912527|NCT01053741|B2|Baseline|Normosol-R Then Seminal Fluid|"2.5 mL radiolabeled Normosol-R administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled autologous seminal fluid administered rectally X1.~Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.~Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
920564|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
912528|NCT01053741|B1|Baseline|Seminal Fluid Then Normosol|"2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Two week pause between interventions. Then 2.5 mL radiolabeled Normosol-R administered rectally X1.~Radiolabeled autologous seminal fluid: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in seminal fluid vehicle.~Radiolabeled Normosol-R: Autologous lymphocytes labeled with 250 microcuries In-111 and 500 microcuries Tc-99m in Normosol-R fluid vehicle."
912529|NCT01053741|P2|Participant Flow|Normosol-R Then Seminal Fluid|Subjects first received 2.5 mL radiolabeled Normosol-R administered rectally x1. Then a two week pause between interventions. Followed by 2.5 mL radiolabeled autologous seminal fluid administered rectally x1.
912530|NCT01053741|P1|Participant Flow|Seminal Fluid, Then Normosol-R|Subjects first received 2.5 mL radiolabeled autologous seminal fluid administered rectally x1. Than a two week pause between interventions. Followed by 2.5 mL radiolabeled Normosol-R administered rectally x1.
912531|NCT01053741|O2|Outcome|Normosol-R|Normosol-R Intervention
912532|NCT01053741|O1|Outcome|Seminal Fluid|Seminal Fluid Intervention
912533|NCT01053741|E2|Reported Event|Normosol-R|Normosol-R Intervention
912534|NCT01053741|E1|Reported Event|Seminal Fluid|Seminal Fluid Intervention
912535|NCT01053663|B4|Baseline|Total|Total of all reporting groups
912536|NCT01053663|B3|Baseline|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912537|NCT01053663|B2|Baseline|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912538|NCT01053663|B1|Baseline|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912539|NCT01053663|P1|Participant Flow|Oseltamivir - All Participants|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to less than (<) 365 days received 3 milligrams per kilogram (mg/kg); participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912540|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912541|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912542|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912543|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912559|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
913017|NCT01051817|E1|Reported Event|PLACEBO|PLACEBO
912544|NCT01053663|O4|Outcome|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912545|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912597|NCT01053429|P1|Participant Flow|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912546|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912547|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912548|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912549|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912550|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912551|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912552|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912553|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912554|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912555|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912556|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912557|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912558|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912594|NCT01053507|E2|Reported Event|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912560|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912561|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912598|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912562|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912563|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912564|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912565|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912566|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912567|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912568|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912569|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912570|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912571|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912572|NCT01053663|O3|Outcome|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912573|NCT01053663|O2|Outcome|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912574|NCT01053663|O1|Outcome|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912593|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
913018|NCT01051778|B3|Baseline|Total|Total of all reporting groups
912575|NCT01053663|E4|Reported Event|Oseltamivir: All Participants|Participants received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s age. Participants aged 91 to <365 days received 3 mg/kg; participants aged 31 to 90 days received 2.5 mg/kg; and participants aged 0 to 30 days received 2 mg/kg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912599|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
914254|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
912576|NCT01053663|E3|Reported Event|Oseltamivir: Age 0 to 30 Days|Participants aged 0 to 30 days received oseltamivir 2 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912577|NCT01053663|E2|Reported Event|Oseltamivir: Age 31 to 90 Days|Participants aged 31 to 90 days received oseltamivir 2.5 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912578|NCT01053663|E1|Reported Event|Oseltamivir: Age 91 to < 365 Days|Participants aged 91 to <365 days received oseltamivir 3 mg/kg twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
912579|NCT01053507|B3|Baseline|Total|Total of all reporting groups
912580|NCT01053507|B2|Baseline|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912581|NCT01053507|B1|Baseline|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912582|NCT01053507|P2|Participant Flow|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912583|NCT01053507|P1|Participant Flow|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912584|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912585|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912586|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912587|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912588|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912589|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912590|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912591|NCT01053507|O1|Outcome|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912592|NCT01053507|O2|Outcome|Placebo|"In the 30-day Treatment Period, subjects randomized to placebo will treat with 1 tablet placebo x 30 days. Placebo matches Treximet.~Placebo: Each tablet of placebo for oral administration matches Treximet. Placebo is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912638|NCT01053156|B1|Baseline|Minocycline First, Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
912595|NCT01053507|E1|Reported Event|Treximet|"In the 30-day Treatment Period, subjects randomized to Treximet will treat with 1 tablet Treximet (sumatriptan 85mg / naproxen sodium 500mg) per day x 30 days.~sumatriptan/naproxen sodium: Each tablet of Treximet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day at the same time each day x 30 days in the Treatment Period."
912596|NCT01053429|B1|Baseline|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912600|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912601|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912602|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912603|NCT01053429|O1|Outcome|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912604|NCT01053429|E1|Reported Event|Ziprasidone HCl (Zeldox)|Ziprasidone hydrochloride (HCl) dosed according to the approved indications for disease diagnosis per local product document
912605|NCT01053312|B1|Baseline|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
912606|NCT01053312|P1|Participant Flow|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
912607|NCT01053312|O1|Outcome|Amyloid Level (Plaque Load)|Amlyoid level estimate from the Immunohistochemistry assay: Percent plaque area (average across slides) for mAb NAB228.
912608|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
912609|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
912610|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
912611|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
912612|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
912613|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
912614|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-(less than 10µg of flutemetamol).
912615|NCT01053312|O7|Outcome|Subject 201-0007|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
912616|NCT01053312|O6|Outcome|Subject 201-0006|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
912617|NCT01053312|O5|Outcome|Subject 201-0005|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
912618|NCT01053312|O4|Outcome|Subject 201-0004|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
912619|NCT01053312|O3|Outcome|Subject 201-0003|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
912620|NCT01053312|O2|Outcome|Subject 201-0002|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
912621|NCT01053312|O1|Outcome|Subject 201-0001|[18F]flutemetamol Injection-less than 10µg of flutemetamol.
912622|NCT01053312|E1|Reported Event|Flutemetamol Injection|[18F]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 megabecquerels(MBq).
912623|NCT01053247|B4|Baseline|Total|Total of all reporting groups
912624|NCT01053247|B3|Baseline|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
912625|NCT01053247|B2|Baseline|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
912626|NCT01053247|B1|Baseline|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
912627|NCT01053247|P3|Participant Flow|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
912628|NCT01053247|P2|Participant Flow|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
912629|NCT01053247|P1|Participant Flow|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
912630|NCT01053247|O3|Outcome|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
912631|NCT01053247|O2|Outcome|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
912632|NCT01053247|O1|Outcome|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
912633|NCT01053247|E3|Reported Event|Vehicle|"Placebo that contains no active pharmaceutical ingredient~Vehicle of Tacrolimus Ointment 0.1% applied twice daily for 2 weeks"
912634|NCT01053247|E2|Reported Event|Reference|"Reference product that contains active pharmaceutical ingredient~Protopic Ointment 0.1%: Reference Product applied twice daily for 2 weeks."
912635|NCT01053247|E1|Reported Event|Test|"Test product that contains the active pharmaceutical ingredient~Tacrolimus Ointment 0.1% test product applied twice daily for 2 weeks"
912636|NCT01053156|B3|Baseline|Total|Total of all reporting groups
912637|NCT01053156|B2|Baseline|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
912639|NCT01053156|P2|Participant Flow|Placebo First, Minocycline Second|Placebo will be given once daily for 3 months, then minocycline dosed once daily for 3 months
912640|NCT01053156|P1|Participant Flow|Minocycline First, Then Placebo Second|Minocycline hydrochloride dosed orally once a day for 3 months, the switched to placebo dosed orally once a day for 3 months.
912641|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912642|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912643|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912772|NCT01052545|B3|Baseline|Total|Total of all reporting groups
920565|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
912644|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912645|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912646|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912647|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912648|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912649|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912650|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912651|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912652|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912653|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912654|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912655|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912656|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912657|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912658|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912659|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912660|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912661|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912662|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912663|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912664|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912665|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912666|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912667|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912668|NCT01053156|O3|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912669|NCT01053156|O2|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912670|NCT01053156|O1|Outcome|Baseline|Prior to any intervention being started.
912671|NCT01053156|O2|Outcome|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912788|NCT01052480|B2|Baseline|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912672|NCT01053156|O1|Outcome|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912673|NCT01053156|E2|Reported Event|Placebo|Placebo dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912674|NCT01053156|E1|Reported Event|Minocycline|Minocycline dosage was assigned based on weight, with patients weighing up to 25 kg receiving 25mg once daily, those weighing between 25 and 45 kg receiving 50 mg once daily, and those weighing >45 kg receiving 100 mg once daily.
912675|NCT01053078|B3|Baseline|Total|Total of all reporting groups
912676|NCT01053078|B2|Baseline|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912677|NCT01053078|B1|Baseline|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912678|NCT01053078|P2|Participant Flow|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912679|NCT01053078|P1|Participant Flow|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912680|NCT01053078|O2|Outcome|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912681|NCT01053078|O1|Outcome|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912682|NCT01053078|E2|Reported Event|Placebo|"Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912683|NCT01053078|E1|Reported Event|Naltrexone|"Double blind placebo comparable~Naltrexone: 1 month treatment~Naltrexone: Naltrexone 25 mg once daily with dose escalation to 50 mg BID to day 28"
912684|NCT01053000|B1|Baseline|All Study Participants|"Tazorac o.1% gel foer 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment vs ALA-PDT with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
912685|NCT01053000|P2|Participant Flow|Right Arm Tazorac/Left Arm No Pretreatment|Tazorac 0.1% gel was applied for 1 week to the right arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
912686|NCT01053000|P1|Participant Flow|Left Arm Tazorac/Right Arm No Tazorac Pre-treatment|Tazorac 0.1% gel was applied for 1 week to the left arm followed by therapy with aminolevulinic acid (ALA-PDT) to both arms, in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light.
912687|NCT01053000|O2|Outcome|No Pretreatment With Tzorac|"No pretreatmnet to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
912688|NCT01053000|O1|Outcome|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
912689|NCT01053000|E2|Reported Event|No Pretreatment Arm|"No Pretreatment to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) with occlusion only (no pretreatment) in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
912690|NCT01053000|E1|Reported Event|Tazorac Treated Arm|"Tazorac o.1% gel for 1 week to the randomly chosen arm~20% aminolevulinic acid HCL: compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) following topical retinoid pre-treatment in subjects with dorsal hand/forearm actinic keratoses, with an incubation time of 60 minutes, using blue light."
912691|NCT01052948|B5|Baseline|Total|Total of all reporting groups
912692|NCT01052948|B4|Baseline|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
912693|NCT01052948|B3|Baseline|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
912694|NCT01052948|B2|Baseline|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
912695|NCT01052948|B1|Baseline|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
912696|NCT01052948|P4|Participant Flow|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
912697|NCT01052948|P3|Participant Flow|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
912698|NCT01052948|P2|Participant Flow|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
912818|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912699|NCT01052948|P1|Participant Flow|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
912700|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
912701|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
912922|NCT01052077|P3|Participant Flow|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
920566|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
912702|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
912703|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
912704|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
912705|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
912706|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
912707|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
912708|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
912709|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
912710|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
912711|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
912712|NCT01052948|O4|Outcome|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
912713|NCT01052948|O3|Outcome|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
912714|NCT01052948|O2|Outcome|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
912715|NCT01052948|O1|Outcome|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
912716|NCT01052948|E4|Reported Event|Healthy Controls (Cohort 4)|Healthy control participants matched (1:1) with participants in the DA cohort (Cohort 1) for age (exact year), gender, database and date of start of DA.
912717|NCT01052948|E3|Reported Event|Hyperprolactinemia (Cohort 3)|Participants with newly diagnosed hyperprolactinemia (excluding postpartum hyperprolactinemia), who had not been treated with DAs anytime prior.
912718|NCT01052948|E2|Reported Event|Levodopa (Cohort 2)|Participants with PD/Parkinsonism or RLS who newly started treatment with Levodopa: Levodopa and decarboxylase inhibitor; Levodopa, decarboxylase inhibitor and catechol-O-methyl transferase [COMT] inhibitor; MeLevodopa; MeLevodopa and decarboxylase inhibitor; or EtiLevodopa and decarboxylase inhibitor and had not been treated with DAs anytime prior.
912719|NCT01052948|E1|Reported Event|Dopamine Agonist (Cohort 1)|Participants with Parkinson's Disease (PD)/Parkinsonism, Restless Legs Syndrome (RLS) or hyperprolactinemia (previously treated) who newly started one of the ergot-derived Dopamine Agonists (DAs): Lisuride, Cabergoline, Metergoline, Bromocriptine, Pergolide, Dihydroergocryptine mesylate, Quinagolide, Ropinirole, Pramipexole, Piribedil, or Rotigotine.
912720|NCT01052844|B3|Baseline|Total|Total of all reporting groups
912721|NCT01052844|B2|Baseline|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912914|NCT01052116|O2|Outcome|Placebo|"Matching placebo~Tablet twice daily"
912915|NCT01052116|O1|Outcome|Soy Isoflavone|"Oral soy isoflavone supplement~tablet twice daily (100 mg/day)"
912722|NCT01052844|B1|Baseline|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912723|NCT01052844|P2|Participant Flow|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912724|NCT01052844|P1|Participant Flow|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912725|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912726|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912727|NCT01052844|O2|Outcome|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912728|NCT01052844|O1|Outcome|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912729|NCT01052844|E2|Reported Event|Gabapentin|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Gabapentin 300mg:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912730|NCT01052844|E1|Reported Event|Control Group|"Dexamethasone 10mg + Ondansetron 8mg + Ranitidine 50mg , IV, before chemotherapy infusion (D1)~Dexamethasone 8mg orally 24h (day 2) and 48h (day 3) after chemotherapy~Placebo:~Five and four days before chemotherapy (day -5 and day -4): 1x daily~Three and two days before chemotherapy (day -3 and day -2): 2x daily~One day before to five days after chemotherapy ( day -1 to day 5): 3x daily"
912731|NCT01052831|B3|Baseline|Total|Total of all reporting groups
912732|NCT01052831|B2|Baseline|Placebo|"Participants will receive placebo treatment~Placebo: 50-100 mg qd for 8 weeks"
912733|NCT01052831|B1|Baseline|Naltrexone|"Participants will receive Naltrexone~Naltrexone: 50-100 mg qd for 8 weeks"
912734|NCT01052831|P2|Participant Flow|Placebo|Participants received the placebo treatment which looked identical to active study medication.
912735|NCT01052831|P1|Participant Flow|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
912736|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
912737|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
912738|NCT01052831|O2|Outcome|Placebo|Participants received the placebo treatment which looked identical to active study medication.
912739|NCT01052831|O1|Outcome|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
912740|NCT01052831|E2|Reported Event|Placebo|Participants received the placebo treatment which looked identical to active study medication.
912741|NCT01052831|E1|Reported Event|Naltrexone|For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study.
912742|NCT01052701|B3|Baseline|Total|Total of all reporting groups
912743|NCT01052701|B2|Baseline|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
912744|NCT01052701|B1|Baseline|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
912745|NCT01052701|P2|Participant Flow|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
912746|NCT01052701|P1|Participant Flow|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
912916|NCT01052116|E2|Reported Event|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
912747|NCT01052701|O2|Outcome|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
912748|NCT01052701|O1|Outcome|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
912749|NCT01052701|O2|Outcome|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
912750|NCT01052701|O1|Outcome|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
912751|NCT01052701|E2|Reported Event|Ribavirin Alone|"Ribavirin alone administration~Ribavirin: Daily Ribavirin alone 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~OR~Daily RBV alone 600 mg orally every 12 hours (Body Weight >75 kg)"
912752|NCT01052701|E1|Reported Event|Ribavirin Plus Abacavir|"Ribavirin plus Abacavir Administration intervention~Ribavirin plus Abacavir: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)~or~Daily RBV 600 mg orally every 12 hours (Body Weight >75 kg)~plus~Daily Abacavir 300 mg orally every 12 hours"
912753|NCT01052662|B4|Baseline|Total|Total of all reporting groups
912754|NCT01052662|B3|Baseline|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
912755|NCT01052662|B2|Baseline|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
912756|NCT01052662|B1|Baseline|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
912757|NCT01052662|P3|Participant Flow|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
912758|NCT01052662|P2|Participant Flow|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
912759|NCT01052662|P1|Participant Flow|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
912760|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
912789|NCT01052480|B1|Baseline|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912917|NCT01052116|E1|Reported Event|Placebo|"Matching placebo~Tablet twice a day"
912761|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
912958|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912762|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
912763|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
912764|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
912765|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
912766|NCT01052662|O3|Outcome|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
912767|NCT01052662|O2|Outcome|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
912768|NCT01052662|O1|Outcome|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
912769|NCT01052662|E3|Reported Event|Memantine 0mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Matching placebo capsule was started on week 2. The placebo capsules were given on a twice a day schedule until week 12 and then discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Placebo: Placebo orally everyday for 12 weeks"
912770|NCT01052662|E2|Reported Event|Memantine 15mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 15 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 15 mg/day Memantine orally everyday for 12 weeks"
912790|NCT01052480|P2|Participant Flow|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912918|NCT01052077|B3|Baseline|Total|Total of all reporting groups
912771|NCT01052662|E1|Reported Event|Memantine 30mg/Day + Buprenorphine|"Participants were inducted onto buprenorphine/naloxone sublingual tablets during the first week of study participation. The dose was titrated from bup/nal 8mg to bup/nal 16mg in three days where it will remain until the last day of week 8. The 7-day discontinuation of buprenorphine-naloxone on week 9 was 12mg, 10mg, 8mg, 6mg, 4mg, 2mg, 2mg and stopped.~Memantine 5mg in the morning was started on week 2. The dose was titrated on a twice a day schedule until the target dose of 30 mg/day was achieved by week 4. The medication was discontinued over a one-week period on week 13. Patients received a 7-day supply of their medication each week.~Memantine: 30mg/day Memantine orally everyday for 12 weeks"
912773|NCT01052545|B2|Baseline|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
912774|NCT01052545|B1|Baseline|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
912775|NCT01052545|P2|Participant Flow|Arm 2- Control|This was the contemporary control group. Surveillance for the outcomes of interest (urine cultures order and antibiotics used to treat urine cultures) continued for all 3 years. Providers at this site received standard education about the CAUTI and asymptomatic bacteriuria guidelines delivered in a grand rounds format, and they also received a PDF of the full guidelines by email.
912776|NCT01052545|P1|Participant Flow|Arm 1- Intervention: Audit-Feedback|"Year 1: baseline surveillance at both sites Year 2: case based, individual audit and feedback delivered to providers, a guidelines based diagnostic algorithm for CAUTI versus asymptomatic bacteriuria (ASB) was given to providers and reinforced in the audit and feedback sessions.~Year 3: cased based, group audit and feedback delivered to providers, again based on this dignostic algorithm.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
912777|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
912778|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
912779|NCT01052545|O2|Outcome|Control Group|Cases of positive urine cultures on medicine and extended care wards at the control site
912780|NCT01052545|O1|Outcome|Intervention Group|Cases of positive urine cultures on medicine and extended care wards at the intervention site
912781|NCT01052545|O2|Outcome|Control Group|Medicine and extended care wards at control site
912782|NCT01052545|O1|Outcome|Intervention Group|Medicine and extended care wards at the intervention site
912783|NCT01052545|O2|Outcome|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
912784|NCT01052545|O1|Outcome|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
912785|NCT01052545|E2|Reported Event|Arm 2- Control|At the control site, baseline surveillance for the clinical outcomes will begin in year 1 at the and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will not occur at the control site. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the control site in year 3 of the project.
912786|NCT01052545|E1|Reported Event|Arm 1-Intervention: Audit-Feedback|"Baseline surveillance for the clinical outcomes will begin in year 1 at the intervention site and continue for all 3 years of the project. Guideline distribution will begin in year 2 and continue throughout the project. Audit-feedback will occur during year 2 of the study at the intervention site. Feedback will be delivered to individual health care providers at the intervention site during year 2.Unit-level audit feedback will be delivered at the intervention site during years 2 and 3 of the study. Provider surveys of knowledge and attitudes concerning the ABU guidelines will be administered at the intervention site in years 2 and 3 of the project.~Audit-Feedback: Applied as a post-prescription antimicrobial review based on established guidelines."
912787|NCT01052480|B3|Baseline|Total|Total of all reporting groups
912791|NCT01052480|P1|Participant Flow|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912792|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912895|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912793|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912794|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912795|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912796|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912797|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912798|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912799|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912800|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912801|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912802|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912803|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912804|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912805|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912806|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912807|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912808|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912809|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912810|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912811|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912812|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912813|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912814|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912815|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912816|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912817|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
913019|NCT01051778|B2|Baseline|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
912819|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912820|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912821|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912822|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912823|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912824|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912825|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912826|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912827|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912828|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912829|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912830|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912831|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912832|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912833|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912834|NCT01052480|O2|Outcome|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912835|NCT01052480|O1|Outcome|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912836|NCT01052480|E2|Reported Event|Standard Care|"Participants will receive standard care.~Standard Care: Standard care for hospitalized people with influenza"
912837|NCT01052480|E1|Reported Event|Plasma and Standard Care|"Participants will receive plasma with high titer anti-influenza A or anti-influenza B antibodies in addition to standard care.~Anti-Influenza Immune Plasma: 2 units of plasma with high titer anti-influenza A or anti-influenza B antibodies at baseline~Standard Care: Standard care for hospitalized people with influenza"
912838|NCT01052428|B3|Baseline|Total|Total of all reporting groups
912839|NCT01052428|B2|Baseline|Toprol-XL|
912840|NCT01052428|B1|Baseline|Placebo|
912841|NCT01052428|P2|Participant Flow|Toprol-XL|
912842|NCT01052428|P1|Participant Flow|Placebo|
912843|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
912844|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
912845|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
912846|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
912847|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
912848|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
912849|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
912850|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
912851|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
912852|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
912853|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
912854|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
912855|NCT01052428|O2|Outcome|Toprol XL|Generic name metoprolol succinate
912856|NCT01052428|O1|Outcome|Placebo|Pill that looks like Toprol XL but does not have the active ingredients
912857|NCT01052428|E2|Reported Event|Toprol-XL|
912858|NCT01052428|E1|Reported Event|Placebo|
912859|NCT01052272|B5|Baseline|Total|Total of all reporting groups
913020|NCT01051778|B1|Baseline|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
912860|NCT01052272|B4|Baseline|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912959|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912861|NCT01052272|B3|Baseline|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912862|NCT01052272|B2|Baseline|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912863|NCT01052272|B1|Baseline|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912864|NCT01052272|P4|Participant Flow|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912865|NCT01052272|P3|Participant Flow|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912866|NCT01052272|P2|Participant Flow|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912867|NCT01052272|P1|Participant Flow|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912868|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912869|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912870|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912871|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912872|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912873|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912874|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912875|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912876|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912919|NCT01052077|B2|Baseline|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
941156|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
912894|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912877|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912878|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912879|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912880|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912881|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912882|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912883|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912884|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912885|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912886|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912887|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912888|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912889|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912890|NCT01052272|O2|Outcome|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912891|NCT01052272|O1|Outcome|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912892|NCT01052272|O4|Outcome|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912893|NCT01052272|O3|Outcome|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912953|NCT01052038|P1|Participant Flow|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912896|NCT01052272|E4|Reported Event|Candesartan Cilexetil and Allopurinol|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily. The starting dose of Allopurinol is 300 mg daily.
912897|NCT01052272|E3|Reported Event|Ramipril and Allopurinol|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily. It is anticipated that the starting dose of each drug will be initiated in hospital and that the second dose will be implemented prior to discharge from the hospital. The starting dose of Allopurinol is 300 mg daily.
912898|NCT01052272|E2|Reported Event|Candesartan Cilexetil|The starting dose of Candesartan cilexetil will be 4 mg or 8 mg once daily and doubled every 2 weeks, if systolic blood pressure is greater than 100 mmHg, to a maximum dose of 32 mg once daily. After one month the patient will return to clinic for blood pressure check and will be titrated up to 32 mg once daily.
912899|NCT01052272|E1|Reported Event|Ramipril|The starting dose of Ramipril will be 2.5 mg once daily and rapidly titrated upward to 5 mg once daily after 5 days if systolic blood pressure is greater than 100 mmHg. After one month the patient will return to clinic for blood pressure check and will be titrated up to 10 mg once daily.
912900|NCT01052207|B3|Baseline|Total|Total of all reporting groups
912901|NCT01052207|B2|Baseline|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
912902|NCT01052207|B1|Baseline|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
912903|NCT01052207|P2|Participant Flow|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
912904|NCT01052207|P1|Participant Flow|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
912905|NCT01052207|O2|Outcome|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
912906|NCT01052207|O1|Outcome|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected."
912907|NCT01052207|E2|Reported Event|Healthy Controls|Healthy controls will be evaluated and defined as those who do not have any chronic medical condition, are not on steroids (inhaled or oral), and have not received steroids or etomidate in the last month. Given the time and need for multiple lab draws low dose adrenocorticotropin (ACTH) testing will not be done in healthy patients, nor will tracheal aspirate samples be obtained.
912908|NCT01052207|E1|Reported Event|Critically Ill Patients|"Evaluation of Oxidative Stress, Glucocorticoid Receptor function, and Adrenal Insufficiency amongst critically ill pediatric patients. Serum, and when available endotracheal samples, will be obtained within 24 hours of admission and at 5 days provided patients are 1) still in the PICU and 2) blood draws and endotracheal aspirates are part of their standard of care. Endotracheal aspirates will be sent on day 14, 21, and 28 provided patients are intubated and require suctioning as part of their standard of care.~Cortrosyn: Subjects : a 1 microgram (mcg) dose of Cosyntropin via intravenous access. After 30 minutes, blood samples collected. only if deemed part of their clinical care"
912909|NCT01052116|B3|Baseline|Total|Total of all reporting groups
912910|NCT01052116|B2|Baseline|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
912911|NCT01052116|B1|Baseline|Placebo|"Matching placebo~Tablet twice a day"
912912|NCT01052116|P2|Participant Flow|Soy Isoflavone|"Oral soy isoflavone supplement~Tablet twice a day (100 mg/day)"
912913|NCT01052116|P1|Participant Flow|Placebo|Matching placebo
912920|NCT01052077|B1|Baseline|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912921|NCT01052077|P4|Participant Flow|Phase A+|Participants who met the criteria for a response at the end of the 8 weeks prospective treatment phase received single-blind placebo + ADT for an additional 6 weeks in Phase A+ for a total of 14 weeks.
912960|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
912923|NCT01052077|P2|Participant Flow|Brexiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912924|NCT01052077|P1|Participant Flow|Phase A|Participants entered a single-blind prospective treatment phase during which they received single-blind placebo plus open-label commercially available ADT for 8 weeks at maximally tolerated doses.
912925|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912926|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912927|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912928|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912929|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912930|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912931|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912932|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912933|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912934|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912935|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912936|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912937|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912938|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912939|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912940|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912941|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912942|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912943|NCT01052077|O2|Outcome|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912944|NCT01052077|O1|Outcome|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912945|NCT01052077|E2|Reported Event|Placebo|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to placebo arm plus the final dosage of the assigned open-label marketed ADT.
912946|NCT01052077|E1|Reported Event|Brexpiprazole|Participants with an incomplete response at the end of treatment phase (Week 8) were randomized to brexpiprazole arm 1 to 3 mg/day, plus the final dosage of the assigned open-label marketed ADT.
912947|NCT01052038|B4|Baseline|Total|Total of all reporting groups
912948|NCT01052038|B3|Baseline|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
912949|NCT01052038|B2|Baseline|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912950|NCT01052038|B1|Baseline|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912951|NCT01052038|P3|Participant Flow|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
912952|NCT01052038|P2|Participant Flow|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912954|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
912955|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912956|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912957|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
914255|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
912961|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912962|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912963|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
912964|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912965|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912966|NCT01052038|O3|Outcome|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
912967|NCT01052038|O2|Outcome|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912968|NCT01052038|O1|Outcome|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912969|NCT01052038|E3|Reported Event|Group 3:Dexamethasone 0.1mg/kg|Dexamethasone 0.1mg/kg administered in 100ml of sterile saline solution prior to surgery.
912970|NCT01052038|E2|Reported Event|Group 2: Dexamethasone 0.05mg/kg|Dexamethasone 0.05 mg/kg administered in 100 ml of sterile saline solution prior to surgery
912971|NCT01052038|E1|Reported Event|Group 1 Placebo|Normal saline 100ml (placebo) administered as a intravenous infusion 30 minutes prior to surgery.
912972|NCT01051986|B3|Baseline|Total|Total of all reporting groups
912973|NCT01051986|B2|Baseline|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912974|NCT01051986|B1|Baseline|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
912975|NCT01051986|P2|Participant Flow|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912976|NCT01051986|P1|Participant Flow|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
912977|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912978|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
912979|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912980|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
912981|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912982|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
913011|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
913012|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
913013|NCT01051817|O1|Outcome|AIN457B|10 mg/Kg IV week 0, 2, 4, 8, 12, 16, and 20
912983|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912984|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
913028|NCT01051739|B2|Baseline|Group 2|normal - healthy observers with no eye pathology other than refractive error less than 6 diopters of correction.
913029|NCT01051739|B1|Baseline|Group 1|glaucoma with mean deviation from 0 to -25 dB
912985|NCT01051986|O2|Outcome|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912986|NCT01051986|O1|Outcome|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
912987|NCT01051986|E2|Reported Event|SVG Group|"patients who underwent off-pump coronary artery bypass using saphenous vein composite graft based on the left internal thoracic artery~use saphenous vein as a composite graft connected to the left internal thoracic artery~saphenous vein composite grafting : use saphenous vein as a composite graft connected to the left internal thoracic artery"
912988|NCT01051986|E1|Reported Event|RITA Group|"patient who underwent off-pump coronary artery bypass using right internal thoracic artery composite graft based on the left internal thoracic artery~use right internal thoracic artery as a composite graft connected to the left internal thoracic artery~right internal thoracic artery composite grafting : right internal thoracic artery is used as a composite graft connected to the left internal thoracic artery"
912989|NCT01051921|B1|Baseline|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
912990|NCT01051921|P1|Participant Flow|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
912991|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
912992|NCT01051921|O1|Outcome|CTS-1027, Pegylated Interferon, Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Pegylated Interferon, individual syringes delivering 180 µg of drug in 0.5 ml of solution administered once weekly.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
912993|NCT01051921|E1|Reported Event|CTS-1027, Pegylated Interferon, Ribavirin|CTS-1027 plus Pegylated Interferon plus ribavirin
912994|NCT01051856|B3|Baseline|Total|Total of all reporting groups
912995|NCT01051856|B2|Baseline|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
912996|NCT01051856|B1|Baseline|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
912997|NCT01051856|P2|Participant Flow|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
912998|NCT01051856|P1|Participant Flow|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
912999|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
913000|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
913001|NCT01051856|O2|Outcome|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
913002|NCT01051856|O1|Outcome|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
913003|NCT01051856|E2|Reported Event|TissueLink With Radiofrequency Ablation|TissueLink with radiofrequency ablation: After pancreatic transection with the method of choice of the operating surgeon, the pancreatic remnant will be treated with Tissuelink alone for an ablation depth (thickness) of approximately 7 mm.
913004|NCT01051856|E1|Reported Event|SEAMGUARD With Bioabsorbable Staple|SEAMGUARD with bioabsorbable staple: In the SEAMGUARD group, pancreatic resection and transection of the pancreatic body will be executed using an endoscopic linear stapling device.
913005|NCT01051817|B3|Baseline|Total|Total of all reporting groups
913006|NCT01051817|B2|Baseline|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
913007|NCT01051817|B1|Baseline|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
913008|NCT01051817|P2|Participant Flow|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
913009|NCT01051817|P1|Participant Flow|AIN457|IV dose 10 mg/kg week 0, 2, 4, 8, 12, 16, and 20.
913010|NCT01051817|O2|Outcome|Placebo|Placebo IV week 0, 2, 4, 8, 12, 16, and 20.
913021|NCT01051778|P2|Participant Flow|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
913022|NCT01051778|P1|Participant Flow|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
913023|NCT01051778|O2|Outcome|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
913024|NCT01051778|O1|Outcome|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
913025|NCT01051778|E2|Reported Event|Heparin Calcium 5,000 U Twice Daily Plus Low Dose Aspirin|
913026|NCT01051778|E1|Reported Event|Enoxaparin 40 mg /Day Plus Low Dose Aspirin|
913027|NCT01051739|B3|Baseline|Total|Total of all reporting groups
913030|NCT01051739|P2|Participant Flow|Group 2|normal ocular healthy controls
913032|NCT01051739|O2|Outcome|Control|Age-matched healthy observers were tested at baseline and then every six months for 4 years
913033|NCT01051739|O1|Outcome|Glaucoma|mean deviation 0 to -25 dB
913034|NCT01051739|E2|Reported Event|Group 2|"normal~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
913035|NCT01051739|E1|Reported Event|Group 1|"glaucoma~Comparison of four visual field testing strategies: We compared the ability of four perimetric strategies to detect visual field change in the glaucoma arm."
913036|NCT01051570|B1|Baseline|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
913037|NCT01051570|P1|Participant Flow|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
913038|NCT01051570|O1|Outcome|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
913039|NCT01051570|E1|Reported Event|Carboplatin, RAD 001 & Prednisone|"Carboplatin: AUC=4 by Calvert’s formula (max dose 600 mg)*IV over 30-60 min, Day 1 of a 21 day cycle~RAD 001: 5 mg Orally daily, starting from Day 2 continuously~Prednisone 5 mg Orally twice daily, continuously~carboplatin: AUC = 5 by Calvert's formula, day 1 of each 21 day cycle~RAD 001: 5 mg orally starting on Day 2 then continuous~prednisone: 5 mg orally twice a day starting on Day 1 then continuous~laboratory biomarker analysis: Samples will be collected from archival tissue.~pharmacological study: Samples will be collected Cycle 1, day 1, 2 & 8 and Cycle 2, Day 1 & 2"
913040|NCT01051557|B8|Baseline|Total|Total of all reporting groups
913041|NCT01051557|B7|Baseline|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913042|NCT01051557|B6|Baseline|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913043|NCT01051557|B5|Baseline|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913044|NCT01051557|B4|Baseline|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913045|NCT01051557|B3|Baseline|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913046|NCT01051557|B2|Baseline|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913047|NCT01051557|B1|Baseline|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913048|NCT01051557|P7|Participant Flow|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913049|NCT01051557|P6|Participant Flow|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913580|NCT01050569|P3|Participant Flow|Nicotine Patch|Nicotine Patch: 21 mg. Nicotine patch was administered on a daily basis for a period of 6 weeks.
913050|NCT01051557|P5|Participant Flow|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913051|NCT01051557|P4|Participant Flow|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913052|NCT01051557|P3|Participant Flow|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913692|NCT01050062|P2|Participant Flow|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913053|NCT01051557|P2|Participant Flow|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913054|NCT01051557|P1|Participant Flow|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913055|NCT01051557|O1|Outcome|Treatment (Temsirolimus and Perifosine)|"PHASE I: Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22 and perifosine PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive temsirolimus and perifosine as in phase I. Some patients may also undergo cytoreductive surgery."
913056|NCT01051557|E7|Reported Event|7 (Temsirolimus: 170 mg/wk Perifosine: 900 mg Loading Dose )|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 900 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913057|NCT01051557|E6|Reported Event|6 (Temsirolimus: 170 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 170 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913058|NCT01051557|E5|Reported Event|5 (Temsirolimus: 115 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 115 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913059|NCT01051557|E4|Reported Event|4 (Temsirolimus: 75 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 75 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913060|NCT01051557|E3|Reported Event|3 (Temsirolimus: 50 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28 Cycle 2+ Temsirolimus: 50 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913061|NCT01051557|E2|Reported Event|2 (Temsirolimus: 25 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 25 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913062|NCT01051557|E1|Reported Event|1 (Temsirolimus: 15 mg/wk)|Cycle = 28 days: Cycle 1 Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 600 mg loading dose PO on day 1and maintence dose 100 mg PO QD on days 2-28, Cycle 2+ Temsirolimus: 15 mg/wk IV over 30 min Perifosine: 100 mg maint dose PO QD on days 1-28
913063|NCT01051466|B3|Baseline|Total|Total of all reporting groups
913064|NCT01051466|B2|Baseline|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913065|NCT01051466|B1|Baseline|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913066|NCT01051466|P2|Participant Flow|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913067|NCT01051466|P1|Participant Flow|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913068|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913861|NCT01049360|P2|Participant Flow|Sequence 2|Aclidinium/Formoterol 400/12 - Aclidinium - Formoterol - Placebo
913069|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom (UK) Edition (WAIS-III^UK). Healthy participants did not receive study drug.
913122|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913123|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913070|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913071|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913072|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913073|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913074|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913075|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913076|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913077|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913078|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913079|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913080|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913094|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913862|NCT01049360|P1|Participant Flow|Sequence 1|Aclidiunium/Formoterol 400/6 - Aclidiunium/Formoterol 400/12 - Aclidinium - Formoterol
913124|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913081|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913082|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913083|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913084|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913085|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913086|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913087|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913088|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913089|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913090|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913091|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913092|NCT01051466|O2|Outcome|Healthy Participants|Healthy participants: Participants who successfully completed screening, were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913093|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913863|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
913095|NCT01051466|O1|Outcome|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD), who successfully completed screening, received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose. At study completion, participants could optionally complete a 2-week dose down-titration taper.
913096|NCT01051466|E2|Reported Event|Healthy Participants|Healthy participants: Participants were matched by age, gender, and intelligence quotient (IQ) to participants with MDD. IQ was measured by the Wechsler Adult Intelligence Scale - Third United Kingdom Edition (WAIS-III UK). Healthy participants did not receive study drug.
913097|NCT01051466|E1|Reported Event|Duloxetine|Duloxetine: Participants with major depressive disorder (MDD) received 60 milligrams (mg) up to 120 mg orally, once daily (QD) for 12 weeks. The initial starting dose was 60 mg duloxetine QD for the first 8 weeks. Then, remitters [defined as participants with a 17-item Hamilton Depression Rating Scale (HAMD17) total score ≤7] continued on 60 mg duloxetine QD, while non-remitters (HAMD17 total score >7) could have their duloxetine dose flexed between 60 mg QD up to 120 mg QD, based on the clinical judgment of the Principal Investigator and tolerability of the participant to the dose.
913098|NCT01051440|B3|Baseline|Total|Total of all reporting groups
913099|NCT01051440|B2|Baseline|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
913100|NCT01051440|B1|Baseline|Placebo|Subjects received matched placebo for lisdexamfetamine.
913101|NCT01051440|P2|Participant Flow|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
913102|NCT01051440|P1|Participant Flow|Placebo|Subjects received matched placebo for lisdexamfetamine.
913103|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
913104|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
913105|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
913106|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
913107|NCT01051440|O2|Outcome|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
913108|NCT01051440|O1|Outcome|Placebo|Subjects received matched placebo for lisdexamfetamine.
913109|NCT01051440|E2|Reported Event|Lisdexamfetamine|Subjects started with 20 mg per day of lisdexamfetamine and could have the dose increased to a maximum of 40 mg based on change in clinical response and adverse events.
913110|NCT01051440|E1|Reported Event|Placebo|Subjects received matched placebo for lisdexamfetamine.
913111|NCT01051323|B3|Baseline|Total|Total of all reporting groups
913112|NCT01051323|B2|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913113|NCT01051323|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913114|NCT01051323|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913115|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913116|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913117|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913118|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913119|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913120|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913121|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913148|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913125|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913126|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (All Participants)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913127|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913128|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913129|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913130|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913131|NCT01051323|O2|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Hemodialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913132|NCT01051323|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Predialysis participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913133|NCT01051323|E2|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Hemodialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913134|NCT01051323|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta (Predialysis)|Participants received methoxy polyethylene glycol-epoetin beta intravenously or subcutaneously as prescribed by the physician and were observed for 12 months. The actual dose was chosen by the physician and was adjusted as necessary.
913135|NCT01050998|B6|Baseline|Total|Total of all reporting groups
913136|NCT01050998|B5|Baseline|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913137|NCT01050998|B4|Baseline|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913138|NCT01050998|B3|Baseline|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913139|NCT01050998|B2|Baseline|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913140|NCT01050998|B1|Baseline|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913141|NCT01050998|P5|Participant Flow|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913142|NCT01050998|P4|Participant Flow|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913143|NCT01050998|P3|Participant Flow|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913144|NCT01050998|P2|Participant Flow|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913145|NCT01050998|P1|Participant Flow|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913146|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913147|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913511|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913149|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913150|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913151|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913152|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913153|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913154|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913155|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913156|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913157|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913158|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913159|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913160|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913161|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913162|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913163|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913164|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913165|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913166|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913167|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913168|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913169|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913170|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913171|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913172|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913173|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913174|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913175|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913176|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913177|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913178|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913864|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
913179|NCT01050998|O4|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913180|NCT01050998|O3|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913181|NCT01050998|O2|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913182|NCT01050998|O1|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913183|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913184|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913185|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913186|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913187|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913188|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913189|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913190|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913191|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913192|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913193|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913194|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913195|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913196|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913197|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913198|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913199|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913200|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913201|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913202|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913203|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913204|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913205|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913206|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913207|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913208|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913865|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
941171|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
913209|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913210|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913211|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913212|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913213|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913214|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913215|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913216|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913217|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913218|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913219|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913220|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913221|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913222|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913223|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913224|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913225|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913226|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913227|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913228|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913229|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913230|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913231|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913232|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913233|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913234|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913235|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913236|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913237|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913238|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913239|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913240|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913241|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913242|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913243|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913244|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913245|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913246|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913247|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913248|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913249|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913250|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913251|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913252|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913253|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913254|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913255|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913256|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913257|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913258|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913259|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913260|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913261|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913262|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913263|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913264|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913265|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913266|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913267|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913268|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913269|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913270|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913271|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913272|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913273|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913274|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913275|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913276|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913277|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913278|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913279|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913280|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913281|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913282|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913283|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913284|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913285|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913286|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913287|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913288|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913289|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913290|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913291|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913292|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913293|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913294|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913295|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913296|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913297|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913298|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913299|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913300|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913686|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913301|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913302|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913303|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913304|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913305|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913306|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913307|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913308|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913309|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913310|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913311|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913312|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913313|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913314|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913315|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913316|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913317|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913318|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913319|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913320|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913321|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913322|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913323|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913324|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913325|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913326|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913327|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913328|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913329|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913330|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913783|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic cerebral palsy participate to pediatric aquatic therapy according preference and finally 11 children complete the study
913331|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913332|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913333|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913334|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913335|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913336|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913337|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913338|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913339|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913340|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913341|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913342|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913343|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913344|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913345|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913346|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913347|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913348|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913349|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913350|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913351|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913352|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913353|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913354|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913355|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913356|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913357|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913358|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913359|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913360|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913784|NCT01049581|E1|Reported Event|Effects of Pediatric Aquatic Therapy on Motor Performance|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I–IV,
913361|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913362|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913363|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913364|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913365|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913366|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913367|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913368|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913369|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913370|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913371|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913372|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913373|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913374|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913375|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913376|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913377|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913378|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913379|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913380|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913381|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913382|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913383|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913384|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913385|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913386|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913387|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913388|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913389|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913390|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913785|NCT01049503|B7|Baseline|Total|Total of all reporting groups
914237|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
913391|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913392|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913393|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913394|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913395|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913396|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913397|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913398|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913399|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913400|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913401|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913402|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913403|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913404|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913405|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913406|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913407|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913408|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913409|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913410|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913411|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913412|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913413|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913414|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913415|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913416|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913417|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913418|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913419|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913420|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913786|NCT01049503|B6|Baseline|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913421|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913422|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913423|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913424|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913425|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913426|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913427|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913428|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913429|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913430|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913431|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913432|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913433|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913434|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913435|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913436|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913437|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913438|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913439|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913440|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913441|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913442|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913443|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913444|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913445|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913446|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913447|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913448|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913449|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913450|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913787|NCT01049503|B5|Baseline|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913451|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913452|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913453|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913454|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913455|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913456|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913457|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913458|NCT01050998|O5|Outcome|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913459|NCT01050998|O4|Outcome|Mavrilimumab 50 mg|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913460|NCT01050998|O3|Outcome|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913461|NCT01050998|O2|Outcome|Mavrilimumab 10 mg|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913462|NCT01050998|O1|Outcome|Placebo|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913463|NCT01050998|E5|Reported Event|PLACEBO|Placebo matched to mavrilimumab injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913464|NCT01050998|E4|Reported Event|CAM-3001 100 MG|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913465|NCT01050998|E3|Reported Event|CAM-3001 50 MG|Mavrilimumab (CAM-3001) 50 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913466|NCT01050998|E2|Reported Event|CAM-3001 30 MG|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913467|NCT01050998|E1|Reported Event|CAM-3001 10 MG|Mavrilimumab (CAM-3001) 10 milligram (mg) injection subcutaneously every other week for 12 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) orally or parenterally.
913468|NCT01050946|B1|Baseline|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913469|NCT01050946|P1|Participant Flow|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913470|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913471|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913512|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913513|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913472|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913486|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
913473|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913474|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913475|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913476|NCT01050946|O1|Outcome|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the precondition regimen at discretion of treating physician.~Haploidentical/cord transplant: Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913477|NCT01050946|E1|Reported Event|Haploidentical/Cord Transplant|"Haploidentical/cord transplant with the preconditioning regimen at discretion of treating physician.~Haploidentical/cord transplant : Myeloablative preparative regimen of chemotherapy and radiation followed by mismatch related(haploidentical)donor and one unit umbilical cord blood transplantation.~Conditioning Regimens Choice of regimen at the discretion of the treating physician~Fludarabine 30mg/m2(Days-7,-6,-5,-4,-3)-,Melphalan 70mg/m2(Day -3,-2), ATG 1.5mg/m2(Day-7,-5,-3,-1)~Fludarabine 50mg/m2(Day -6,-5,-4,-3,-2),Busulfan 3.2mg/kg(Day -5,-4,-3,-2),400cGY Total Body Irradiation(TBI)Day-1,ATG 1.5mg/kg(Day-7,-5,-3,-1)~Day 0 -Haploidentical donor and one umbilical cord blood unit infusion"
913478|NCT01050816|B1|Baseline|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
913479|NCT01050816|P1|Participant Flow|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
913480|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
913481|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
913482|NCT01050816|O1|Outcome|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
913483|NCT01050816|E1|Reported Event|Chondron Implantation|Those who agreed to participate voluntarily went through screening to confirm the appropriateness for the clinical trial, and then received appropriate amounts(by size, but mean:4vail(1.6ml)) of CHONDRON (autologous chondrocytes) transplantation.
913484|NCT01050790|B1|Baseline|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
913514|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913515|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913485|NCT01050790|P1|Participant Flow|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
913487|NCT01050790|O1|Outcome|Aza Len Lymphapheresis SCT ALI|Azacitidine will be administered to all the patients subcutaneously at a dose of 75 mg/m2 daily for five days(day 1-5). These cycles will be repeated at 28 day intervals depending on hematopoietic recovery. Starting on day 6 patients will receive lenalidomide 15 mg PO daily until day 21. No drug will be administered from day 22 to day 28. Lymphapheresis will occur after cycles 2 and 3.Patients will undergo a stem cell collection approximately two weeks after complete myeloid recovery from the third cycle of therapy. Stem Cell Transplant (SCT) will occur per transplant center protocols. Post-transplant single or tandem autologous lymphocyte infusions (ALI) will be performed no earlier than 30 days post-transplant and no later than 40 days.
913488|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
913489|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
913490|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
913491|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
913492|NCT01050790|O1|Outcome|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
913493|NCT01050790|E1|Reported Event|5-azacytidine + Lenalidomide -> Auto Stem Cell Transplant|"azacitidine: 75 mg/sq m daily for 5 days~lenalidomide: 10 mg p.o. daily, Days 6-21"
913494|NCT01050764|B1|Baseline|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913495|NCT01050764|P1|Participant Flow|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913496|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913497|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913498|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913499|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913500|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913501|NCT01050764|O1|Outcome|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913502|NCT01050764|E1|Reported Event|Allogeneic T-Cell Infusion After Stem Cell Transplant (SCT)|Allogeneic, haploidentical hematopoietic stem cell transplant (allo-HSCT) of bone marrow and/or peripheral blood stem cells, followed by infusion of regulatory T-cells (T-reg) plus conventional CD4 and CD8 T-cells (T-con)
913503|NCT01050673|B3|Baseline|Total|Total of all reporting groups
913504|NCT01050673|B2|Baseline|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913505|NCT01050673|B1|Baseline|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913506|NCT01050673|P2|Participant Flow|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913507|NCT01050673|P1|Participant Flow|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913508|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913509|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913510|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913516|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913517|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913518|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913519|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913689|NCT01050062|B3|Baseline|Total|Total of all reporting groups
920567|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
913520|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913521|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913522|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913523|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913524|NCT01050673|O2|Outcome|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913525|NCT01050673|O1|Outcome|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913526|NCT01050673|E2|Reported Event|Conventional Therapy|Conventional operating room excision will consist of sharp instrumentation and electrocautery techniques, with the use of pulse lavage at the investigator's discretion. The type of sharp instrumentation, together with the brand of pulse lavage will be recorded.
913527|NCT01050673|E1|Reported Event|VERSAJET|Excision with VERSAJET™ Hydrosurgery System
913528|NCT01050660|B3|Baseline|Total|Total of all reporting groups
913529|NCT01050660|B2|Baseline|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913530|NCT01050660|B1|Baseline|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913531|NCT01050660|P2|Participant Flow|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913532|NCT01050660|P1|Participant Flow|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913533|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913534|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913535|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913536|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913537|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913538|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913539|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913540|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913541|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913542|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913543|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913579|NCT01050569|B1|Baseline|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
913544|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913545|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913546|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913547|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913548|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913549|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913550|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913551|NCT01050660|O2|Outcome|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d : Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913552|NCT01050660|O1|Outcome|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion : An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913553|NCT01050660|E2|Reported Event|Intravenous Fat Emulsion-restricted|Restriction of intravenous fat emulsion to 1 gm/kg/d: Intravenous fat will be started at 0.5 grams/kg on the first day of life and then increase to a dose of 1gram/kg/day the next day. There will be no further increase in the amount of intravenous fat.
913554|NCT01050660|E1|Reported Event|3 gm/kg/Day Intravenous Lipid Emulsion|Intravenous fat emulsion: An infusion of intravenous fat will start at 0.5 grams/kg on the first day of life, with increments of 0.5 -1.0 grams/kg every day, until a total dose of 3 grams/kg is reached.
913555|NCT01050634|B1|Baseline|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
913556|NCT01050634|P1|Participant Flow|Aromasin (Exemestane)|The recommended dosage of exemestane was 25mg once a day.
913557|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
913558|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
913559|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
913560|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
913561|NCT01050634|O1|Outcome|Aromasin (Exemestane)|The recommended dosage of exemestane was 25 mg once a day.
913562|NCT01050634|E1|Reported Event|Observational|
913563|NCT01050582|B3|Baseline|Total|Total of all reporting groups
913564|NCT01050582|B2|Baseline|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
913565|NCT01050582|B1|Baseline|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
913566|NCT01050582|P2|Participant Flow|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
913567|NCT01050582|P1|Participant Flow|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
913568|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
913569|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
913570|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
913571|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
913572|NCT01050582|O2|Outcome|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
913573|NCT01050582|O1|Outcome|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
913574|NCT01050582|E2|Reported Event|Other Atypical Antipsychotics|No risperidone exposure within 24 months of enrollment, no more than 30 days lifetime exposure to risperidone, and at least 6 months exposure to another atypical antipsychotic within 24 months prior to enrollment
913575|NCT01050582|E1|Reported Event|Risperidone|Subjects with at least 6 months exposure to risperidone within 24 months prior to enrollment
913576|NCT01050569|B4|Baseline|Total|Total of all reporting groups
913577|NCT01050569|B3|Baseline|Nicotine Patch|21 mg nicotine patch
913578|NCT01050569|B2|Baseline|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
941172|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
913581|NCT01050569|P2|Participant Flow|VLNC Cigarette Plus Nicotine Patch|Very Low Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield. Nicotine patch was administered on a daily basis. Participants were asked to use experimental cigarettes on an ad lib basis. Products were used for 6 weeks.
913582|NCT01050569|P1|Participant Flow|VLNC Cigarette|Very Low Nicotine Content Cigarette: Cigarette where the tobacco contains <0.1 mg of nicotine yield. Participants were asked to smoke experimental cigarettes in an ad lib basis. Product was used for 6 weeks.
913583|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
913690|NCT01050062|B2|Baseline|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913584|NCT01050569|O2|Outcome|VLNC Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
913585|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
913586|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
913587|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch : 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
913588|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
913589|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
913590|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Content Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
913591|NCT01050569|O1|Outcome|VLNC Cigarette|Very Low Nicotine Content Cigarettes: Cigarette where the tobacco contains <0.1 mg of nicotine yield.
913592|NCT01050569|O3|Outcome|Nicotine Patch|21 mg nicotine patch
913593|NCT01050569|O2|Outcome|VLNC Cigarette Plus Nicotine Patch|Very Low Nicotine Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
913594|NCT01050569|O1|Outcome|VLNC Cigarette|VLNC Cigarettes: Cigarette where the tobacco contains <0.1 mg nicotine yield.
913595|NCT01050569|E3|Reported Event|Nicotine Patch|21 mg nicotine patch
913596|NCT01050569|E2|Reported Event|VLNC Cigarette Plus Nicotine Patch|VLNC Cigarette Plus Nicotine Patch: 21 mg nicotine patch plus use of cigarette with tobacco containing <0.1 mg nicotine yield.
913597|NCT01050569|E1|Reported Event|VLNC Cigarette|Very Low Nicotine Content Cigarettes : Cigarette where the tobacco contains <0.1 mg of nicotine yield.
913598|NCT01050543|B3|Baseline|Total|Total of all reporting groups
913599|NCT01050543|B2|Baseline|Neostigmine|neostigmine 50 mcg/kg
913600|NCT01050543|B1|Baseline|Sugammadex|sugammadex 2 mg/kg
913601|NCT01050543|P2|Participant Flow|Neostigmine|neostigmine 50 mcg/kg
913602|NCT01050543|P1|Participant Flow|Sugammadex|sugammadex 2 mg/kg
913603|NCT01050543|O2|Outcome|Neostigmine|neostigmine 50 mcg/kg
913604|NCT01050543|O1|Outcome|Sugammadex|sugammadex 2 mg/kg
913605|NCT01050543|E2|Reported Event|Neostigmine|neostigmine 50 mcg/kg
913606|NCT01050543|E1|Reported Event|Sugammadex|sugammadex 2 mg/kg
913607|NCT01050530|B3|Baseline|Total|Total of all reporting groups
913608|NCT01050530|B2|Baseline|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
913609|NCT01050530|B1|Baseline|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
913610|NCT01050530|P2|Participant Flow|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
913611|NCT01050530|P1|Participant Flow|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
913612|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
913613|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
913614|NCT01050530|O2|Outcome|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
913615|NCT01050530|O1|Outcome|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
913616|NCT01050530|E2|Reported Event|Placebo|Placebo: Once-daily oral administration of placebo after breakfast for 7 days
913617|NCT01050530|E1|Reported Event|OPC-41061|OPC-41061: Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
913618|NCT01050257|B4|Baseline|Total|Total of all reporting groups
913619|NCT01050257|B3|Baseline|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913620|NCT01050257|B2|Baseline|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913621|NCT01050257|B1|Baseline|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913622|NCT01050257|P3|Participant Flow|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913655|NCT01050257|E3|Reported Event|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
942930|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
913623|NCT01050257|P2|Participant Flow|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913691|NCT01050062|B1|Baseline|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913624|NCT01050257|P1|Participant Flow|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913625|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913626|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913627|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913628|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913629|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913630|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913631|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913632|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913633|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913634|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913635|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913636|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913637|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913638|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
914238|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
913639|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913640|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913641|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913642|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913643|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913644|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913645|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913646|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913647|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913648|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913649|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913650|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913651|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913652|NCT01050257|O3|Outcome|Oseltamivir Open Label|Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
913653|NCT01050257|O2|Outcome|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913654|NCT01050257|O1|Outcome|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
914239|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
913656|NCT01050257|E2|Reported Event|Oseltamivir (TAMIFLU®) 200 mg|Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913657|NCT01050257|E1|Reported Event|Oseltamivir (TAMIFLU®) 100 mg|Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days.
913658|NCT01050218|B1|Baseline|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
913659|NCT01050218|P1|Participant Flow|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
913660|NCT01050218|O1|Outcome|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
913661|NCT01050218|E1|Reported Event|DVS SR Open Label|Daily dose of 100mg or 200mg at the investigators discretion. Subjects already randomized at a dose of 400mg may continue at that dose level.
913662|NCT01050153|B3|Baseline|Total|Total of all reporting groups
913663|NCT01050153|B2|Baseline|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913664|NCT01050153|B1|Baseline|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913665|NCT01050153|P2|Participant Flow|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913666|NCT01050153|P1|Participant Flow|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913667|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913668|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913669|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913670|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913671|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913672|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913673|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913674|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913675|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913676|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913677|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913678|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913679|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913680|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913681|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913682|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913683|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913684|NCT01050153|O1|Outcome|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913685|NCT01050153|O2|Outcome|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913687|NCT01050153|E2|Reported Event|TEG-guided Thromboprophylaxis|"Dalteparin sodium plus/minus anti-platelet medication (aspirin) per a TEG-guided algorithm~Dalteparin sodium/aspirin : Dalteparin sodium (2500-10,000IU sc daily), aspirin (81-325mg daily)po."
913688|NCT01050153|E1|Reported Event|Control (Standard of Care)|"Dalteparin sodium 5000IU subcutaneously daily~Dalteparin sodium : Dalteparin sodium injection 5000IU subcutaneously daily until fully ambulatory"
913693|NCT01050062|P1|Participant Flow|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913694|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
913695|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913696|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913697|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
913698|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913699|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913700|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
913701|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913702|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913703|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
913704|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913705|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913706|NCT01050062|O3|Outcome|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
913707|NCT01050062|O2|Outcome|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913708|NCT01050062|O1|Outcome|Combination Tablet AP|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913709|NCT01050062|E3|Reported Event|Total|Fix dose combination tablets of telmisartan 40/80mg and hydrochlorothiazide 12.5mg
913710|NCT01050062|E2|Reported Event|Combination Tablet BP|Fix dose combination tablets of telmisartan 80mg and hydrochlorothiazide 12.5mg
913711|NCT01050062|E1|Reported Event|Combination Tablet Ap|Fix dose combination tablets of telmisartan 40mg and hydrochlorothiazide 12.5mg
913712|NCT01049984|B3|Baseline|Total|Total of all reporting groups
913713|NCT01049984|B2|Baseline|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913714|NCT01049984|B1|Baseline|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913715|NCT01049984|P2|Participant Flow|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913716|NCT01049984|P1|Participant Flow|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913717|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913718|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913719|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913720|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913721|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913722|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913723|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913724|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913725|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913726|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913727|NCT01049984|O2|Outcome|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913728|NCT01049984|O1|Outcome|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913729|NCT01049984|E2|Reported Event|Rasagiline 1 mg|Participants took a 1 mg rasagiline tablet orally each day for 18 weeks.
913730|NCT01049984|E1|Reported Event|Placebo|Participants took a matching placebo tablet once daily for 18 weeks.
913731|NCT01049945|B3|Baseline|Total|Total of all reporting groups
913732|NCT01049945|B2|Baseline|Maximum Tolerated Dose, Dose Level 4|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
913733|NCT01049945|B1|Baseline|Phase I|Participant demographics were analyzed according to their status for the Phase II Primary Endpoint. All participants registered to Dose Level 4 (the Maximum Tolerated Dose (MTD)) were eligible for the Phase II Primary Endpoint. This group included the 6 patients registered to Phase I, Dose Level 4 and the 49 participants registered to the Phase II portion. The demographic information for all other participants registered to Phase I (Dose Level 1, Dose Level 2, Dose Level 3, and Dose Level 5) were summarized together.
913734|NCT01049945|P6|Participant Flow|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913735|NCT01049945|P5|Participant Flow|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913736|NCT01049945|P4|Participant Flow|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
914256|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
913737|NCT01049945|P3|Participant Flow|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913738|NCT01049945|P2|Participant Flow|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913739|NCT01049945|P1|Participant Flow|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913740|NCT01049945|O1|Outcome|Maximum Tolerated Dose, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
913741|NCT01049945|O5|Outcome|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913742|NCT01049945|O4|Outcome|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913743|NCT01049945|O3|Outcome|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913744|NCT01049945|O2|Outcome|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913745|NCT01049945|O1|Outcome|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913746|NCT01049945|E6|Reported Event|Phase II, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913747|NCT01049945|E5|Reported Event|Phase I, Dose Level 5|Bendamustine 100 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913748|NCT01049945|E4|Reported Event|Phase I, Dose Level 4|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 25 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913749|NCT01049945|E3|Reported Event|Phase I, Dose Level 3|Bendamustine 75 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913750|NCT01049945|E2|Reported Event|Phase I, Dose Level 2|Bendamustine 50 mg/m^2 IV day 1 and 2 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913751|NCT01049945|E1|Reported Event|Phase I, Dose Level 1|Bendamustine 50 mg/m^2 IV day 1 Lenalidomide 15 mg PO days 1-21 Dexamethasone 40 mg PO or IV days 1, 8, 15, 22 Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
913752|NCT01049802|B3|Baseline|Total|Total of all reporting groups
913753|NCT01049802|B2|Baseline|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913754|NCT01049802|B1|Baseline|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913755|NCT01049802|P2|Participant Flow|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913756|NCT01049802|P1|Participant Flow|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913757|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913860|NCT01049360|P3|Participant Flow|Sequence 3|Aclidinium - Formoterol - Placebo - Aclidinium/Formoterol 400/6
943429|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
913758|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913759|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
914257|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
913760|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913761|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913762|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913763|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913764|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913765|NCT01049802|O2|Outcome|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913766|NCT01049802|O1|Outcome|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913767|NCT01049802|E2|Reported Event|Sham Contralesional rTMS Plus Arm Rehabilitation|"Subject will receive sham rTMS to contralesional hemisphere for up to 20 minutes followed by task-oriented arm and hand rehabilitation to affected limb~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913768|NCT01049802|E1|Reported Event|Contralesional rTMS With Arm Rehabilitation|"Experimental subjects will receive subthreshold or suprathreshold rTMS to contralesional hemisphere for up to 20 minutes at 1 Hz followed by task oriented arm and hand therapy to affected limb.~repetitive transcranial magnetic stimulation to contralesional hemisphere: 1 Hz rTMS to contralesional hemisphere in patients with stroke"
913769|NCT01049776|B1|Baseline|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
913770|NCT01049776|P1|Participant Flow|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
913771|NCT01049776|O1|Outcome|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
913772|NCT01049776|E1|Reported Event|Pazapanib (GW786034)|Pazopanib (GW786034): Pazopanib 800 mg daily x 12 weeks, (Cycle = 21 days) up to 24 months
913773|NCT01049581|B3|Baseline|Total|Total of all reporting groups
913774|NCT01049581|B2|Baseline|Conventional Therapy Group|The participants were classified into the control (conventional therapy) group according to preference. The children included in the control group continued with their original rehabilitation programs.
913775|NCT01049581|B1|Baseline|Pediatric Aquatic Therapy Group|The participants were classified into two groups the pediatric aquatic therapy group according the their preference. The children of the PAT group participated in a 1 hour/time, twice-per-week, 12-week, PAT program in addition to conventional rehabilitation programs.
913776|NCT01049581|P2|Participant Flow|Conventional Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the conventional therapy according to preference
913777|NCT01049581|P1|Participant Flow|Pediatric Aquatic Therapy Group|*Children diagnosed with cerebral palsy, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV,participate the pediatric aquatic therapy according to preference
913778|NCT01049581|O2|Outcome|Conventional Therapy|Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate conventional therapy according preference
913779|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|*Children diagnosed with CP, spastic type,*4 to 12 years of age,*Goss Motor Functional Classification System (GMFCS) level I-IV, participate pediatric aquatic therapy according preference
913780|NCT01049581|O2|Outcome|Conventional Therapy|14 children diagnosed as spastic type cerebral palsy participate conventional therapy and 13 children finish the study,each of them fulfill the the questionnaire before and after the intervention
913781|NCT01049581|O1|Outcome|Pediatric Aquatic Therapy|13 children diagnosed as spastic type cerebral palsy participate pediatric auqatic therapy and 11 children finish the study,each of them fulfill the the questionnaire before and after the intervention
913782|NCT01049581|O2|Outcome|Conventional Therapy|Initially 14 children diagnosed as spastic cerebral palsy participate conventional therapy according to preference and 13 children complete the study
944917|NCT00966238|O5|Outcome|5.0 µg i.m.|
913788|NCT01049503|B4|Baseline|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913789|NCT01049503|B3|Baseline|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913790|NCT01049503|B2|Baseline|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
914258|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
913791|NCT01049503|B1|Baseline|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913792|NCT01049503|P6|Participant Flow|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913793|NCT01049503|P5|Participant Flow|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913794|NCT01049503|P4|Participant Flow|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913795|NCT01049503|P3|Participant Flow|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913796|NCT01049503|P2|Participant Flow|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913797|NCT01049503|P1|Participant Flow|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913798|NCT01049503|O3|Outcome|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913799|NCT01049503|O2|Outcome|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913800|NCT01049503|O1|Outcome|Caries-inactive 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913801|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913802|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913803|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913804|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913805|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913806|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913807|NCT01049503|O3|Outcome|1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
913808|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
913809|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the toenails.
913810|NCT01049503|O3|Outcome|Caries-active 1100ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913811|NCT01049503|O2|Outcome|Caries-active 550ppmF, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913812|NCT01049503|O1|Outcome|Caries-active 550ppmF, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913813|NCT01049503|O3|Outcome|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913814|NCT01049503|O2|Outcome|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913815|NCT01049503|O1|Outcome|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913816|NCT01049503|O3|Outcome|1100 ppmF , pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
913817|NCT01049503|O2|Outcome|550 Ppm F, pH 4.5|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
913818|NCT01049503|O1|Outcome|550 Ppm F, pH 7.0|This arm aims to assess the overall effect of the dentifrice pH and fluoride concentration on the concentration of fluoride incorporated into the biofilm.
913819|NCT01049503|E6|Reported Event|Caries-inactive 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913820|NCT01049503|E5|Reported Event|Caries-inactive 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
944918|NCT00966238|O4|Outcome|3.0 µg i.m.|
913821|NCT01049503|E4|Reported Event|Caries-inactive 550ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-inactive children of a fluoridated area
913822|NCT01049503|E3|Reported Event|Caries-active 1100 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913823|NCT01049503|E2|Reported Event|Caries-active 550 Ppm F, pH 4.5|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913824|NCT01049503|E1|Reported Event|Caries-active 550 Ppm F, pH 7.0|This arm aims to assess the overall effect of pH and fluoride concentration in the caries control of caries-active children of a fluoridated area
913825|NCT01049373|B3|Baseline|Total|Total of all reporting groups
913826|NCT01049373|B2|Baseline|Placebo Solution|10 drops t.i.d. for 15 weeks
913827|NCT01049373|B1|Baseline|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913828|NCT01049373|P2|Participant Flow|Placebo Solution|10 drops t.i.d. for 15 weeks
913829|NCT01049373|P1|Participant Flow|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913830|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
913831|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913832|NCT01049373|O2|Outcome|PLACEBO Solution|10 drops t.i.d. for 15 weeks
913833|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913834|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
913835|NCT01049373|O1|Outcome|LYMPHDIARAL (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913836|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
913837|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913838|NCT01049373|O2|Outcome|Placebo Solution|10 drops t.i.d. for 15 weeks
913839|NCT01049373|O1|Outcome|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913840|NCT01049373|E2|Reported Event|Placebo Solution|10 drops t.i.d. for 15 weeks
913841|NCT01049373|E1|Reported Event|Lymphdiaral Basistropfen (HDC)|HDC (Calendula mother tincture, Condurango 2X, Phytolacca 2X, Carduus marianus 1X, Chelidonium 2X, Hydrastis mother tincture, Leptandra mother tincture, Taraxacum mother tincture, Echinacea mother tincture, Lycopodium 2X, Sanguinaria mother tincture and Arsenicum album 8X), each 10 drops t.i.d. for 15 weeks.
913842|NCT01049360|B1|Baseline|Overall Population|Safety population defined as all randomized patients who took at least one dose of double-blind investigational product
913843|NCT01049360|P20|Participant Flow|Sequence 20|Placebo - Formoterol - Aclidinium - Aclidinium/Formoterol 400/12
913844|NCT01049360|P19|Participant Flow|Sequence 19|Formoterol - Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6
913845|NCT01049360|P18|Participant Flow|Sequence 18|Aclidinium - Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo
913846|NCT01049360|P17|Participant Flow|Sequence 17|Aclidinium/Formoterol 400/12 - Aclidinium/Formoterol 400/6 - Placebo - Formoterol
913847|NCT01049360|P16|Participant Flow|Sequence 16|Aclidinium/Formoterol 400/6 - Placebo - Formoterol - Aclidinium
913848|NCT01049360|P15|Participant Flow|Sequence 15|Placebo - Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol
913849|NCT01049360|P14|Participant Flow|Sequence 14|Formoterol - Aclidinium/Formoterol 400/12 - Placebo - Aclidinium
913850|NCT01049360|P13|Participant Flow|Sequence 13|Aclidinium - Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12
913851|NCT01049360|P12|Participant Flow|Sequence 12|Aclidinium/Formoterol 400/12 - Placebo - Aclidinium - Aclidinium/Formoterol 400/6
913852|NCT01049360|P11|Participant Flow|Sequence 11|Aclidinium/Formoterol 400/6 - Formoterol - Aclidinium/Formoterol 400/12 - Placebo
913853|NCT01049360|P10|Participant Flow|Sequence 10|Placebo - Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6
913854|NCT01049360|P9|Participant Flow|Sequence 9|Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium - Placebo
913855|NCT01049360|P8|Participant Flow|Sequence 8|Aclidinium - Placebo - Aclidinium/Formoterol 400/12 - Formoterol
913856|NCT01049360|P7|Participant Flow|Sequence 7|Aclidinium/Formoterol 400/12 - Formoterol - Aclidinium/Formoterol 400/6 - Aclidinium
913857|NCT01049360|P6|Participant Flow|Sequence 6|Aclidinium/Formoterol 400/6 - Aclidinium - Placebo - Aclidinium/Formoterol 400/12
913858|NCT01049360|P5|Participant Flow|Sequence 5|Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12 - Aclidinium
913859|NCT01049360|P4|Participant Flow|Sequence 4|Formoterol - Placebo - Aclidinium/Formoterol 400/6 - Aclidinium/Formoterol 400/12
944919|NCT00966238|O3|Outcome|2.0 µg i.m.|
913866|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
913867|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
913868|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
913869|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
913870|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
913871|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
913872|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
913873|NCT01049360|O5|Outcome|Placebo|Placebo twice-daily
913874|NCT01049360|O4|Outcome|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
913875|NCT01049360|O3|Outcome|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
913876|NCT01049360|O2|Outcome|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
913877|NCT01049360|O1|Outcome|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
913878|NCT01049360|E5|Reported Event|Placebo|Placebo twice-daily
913879|NCT01049360|E4|Reported Event|Formoterol 12 μg|Formoterol fumarate 12 μg twice-daily
913880|NCT01049360|E3|Reported Event|Aclidinium 400 μg|Aclidinium bromide 400 μg administered twice-daily (BID)
913881|NCT01049360|E2|Reported Event|Aclidinium 400 μg / Formoterol 6 μg|Aclidinium bromide 400 μg / formoterol fumarate 6 μg fixed dose combination administered twice-daily (BID)
913882|NCT01049360|E1|Reported Event|Aclidinium 400 μg / Formoterol 12 μg|Aclidinium bromide 400 μg / formoterol fumarate 12 μg fixed dose combination administered twice-daily (BID)
913883|NCT01049308|B1|Baseline|Group 1|veteran population with documented heart failure
913884|NCT01049308|P1|Participant Flow|Heart Failure|veteran population with documented heart failure
913885|NCT01049308|O3|Outcome|Severe CI|veteran population with documented heart failure with severe cognitive impairment (dementia) on SLUMS screening test who finished 30-day pill counts
913886|NCT01049308|O2|Outcome|Mild CI|veteran population with documented heart failure with mild cognitive impairment on SLUMS screening test who finished 30-day pill counts
913887|NCT01049308|O1|Outcome|No CI|veteran population with documented heart failure with no cognitive impairment on SLUMS screening test who finished 30-day pill counts
913888|NCT01049308|O1|Outcome|Heart Failure|veteran population with documented heart failure
913889|NCT01049308|E1|Reported Event|Group 1|veteran population with documented heart failure
913890|NCT01049243|B1|Baseline|Single Group|
913891|NCT01049243|P1|Participant Flow|Vanos|Single group; 0.1% Cream, One Application, Twice Daily, 14 Days
913892|NCT01049243|O1|Outcome|Single Group|
913893|NCT01049243|E1|Reported Event|Single Group|
913894|NCT01049217|B3|Baseline|Total|Total of all reporting groups
913895|NCT01049217|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913896|NCT01049217|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913897|NCT01049217|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913898|NCT01049217|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913973|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
913974|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
914240|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
913982|NCT01048944|B1|Baseline|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
913983|NCT01048944|P4|Participant Flow|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
913984|NCT01048944|P3|Participant Flow|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
913899|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913900|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913901|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913902|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913903|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913904|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913905|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913906|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913907|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913908|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913975|NCT01049009|O1|Outcome|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
913909|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913910|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913911|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913912|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913913|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913914|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913915|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913916|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913917|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913918|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913976|NCT01049009|E2|Reported Event|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
913919|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913920|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913921|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913922|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913923|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913924|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913925|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913926|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913927|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913928|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913977|NCT01049009|E1|Reported Event|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
913929|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913930|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913931|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913932|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913933|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913934|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913935|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913936|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913937|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913938|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913978|NCT01048944|B5|Baseline|Total|Total of all reporting groups
913979|NCT01048944|B4|Baseline|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
914241|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
913939|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913940|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913941|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913942|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913943|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913944|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913945|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913946|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913947|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913948|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913980|NCT01048944|B3|Baseline|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
913949|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913950|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913951|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913952|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913953|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913954|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913955|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913956|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913957|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913958|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913981|NCT01048944|B2|Baseline|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
914242|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
913959|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913960|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913961|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913962|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913963|NCT01049217|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913964|NCT01049217|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913965|NCT01049217|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily up to Week 1, followed by placebo matched to pregabalin 150 mg capsule orally twice daily up to Week 2, then placebo matched to pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated placebo matched to pregabalin 225 mg twice daily received placebo matched to pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Placebo matched to pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913966|NCT01049217|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily up to Week 1, followed by pregabalin 150 mg capsule orally twice daily up to Week 2, then pregabalin 225 mg capsule orally twice daily up to Week 3, participants who had inadequate pain control and had tolerated pregabalin 225 mg twice daily received pregabalin 300 mg capsule orally twice daily up to Week 4, during 4-week titration (adjustment) phase. Pregabalin capsule 75 mg, 150 mg, 225 mg, or 300 mg orally twice daily (as per tolerability in titration phase) from Week 5 to Week 16, during 12-week maintenance phase. Participants underwent an end-of-study medication taper over a 1-week period.
913967|NCT01049009|B3|Baseline|Total|Total of all reporting groups
913968|NCT01049009|B2|Baseline|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
913969|NCT01049009|B1|Baseline|Nebivolol/Metoprolol XL|Subjects were randomized to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after cross over.
913970|NCT01049009|P2|Participant Flow|Metoprolol XL/Nebivolol|Subjects are randomized to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after cross over.
913971|NCT01049009|P1|Participant Flow|Nebivolol/Metoprolol XL|Subjects are randomized to Nebivolol 5mg and titrate to Nebivolol 10mg two weeks after drug initiation. Ten weeks after titration subjects will cross over to Metoprolol XL 50mg and titrate to Metoprolol XL 100mg two weeks after cross over.
913972|NCT01049009|O2|Outcome|Metoprolol XL/Nebivolol|Subjects were randomized to Metoprolol XL 50mg and titrated to Metoprolol XL 100mg two weeks after drug initiation. Ten weeks after titration, subjects crossed over to Nebivolol 5mg and titrated to Nebivolol 10mg two weeks after cross over.
914243|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
913985|NCT01048944|P2|Participant Flow|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
913986|NCT01048944|P1|Participant Flow|Bupropion Sustained Release (SR)|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
913987|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
913988|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
913989|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
913990|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
913991|NCT01048944|O4|Outcome|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
913992|NCT01048944|O3|Outcome|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
913993|NCT01048944|O2|Outcome|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill,3 days 1x/day then 56/day for 2x/day, then 3 day 1x/day ramp-down."
913994|NCT01048944|O1|Outcome|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
913995|NCT01048944|E4|Reported Event|Delayed-quit Control|Smoke for 67 days while others have quit, then quit.
913996|NCT01048944|E3|Reported Event|Placebo Patch and Placebo Pill|"Placebo patch same size as active patches~Placebo pill and Placebo Patch: 150 encapsulated placebo pill,3 days 1x/day then 56 days at 2x/day, then 3 days at 1x/day ramp-down. Placebo patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days."
913997|NCT01048944|E2|Reported Event|Nicotine Patch|"21mg, 14mg, 7mg~Nicotine: Nicotine patch beginning 1st day cessation: 21 mg/24 days, 14 mg/14 days, 7 mg/7 days"
913998|NCT01048944|E1|Reported Event|Bupropion SR|"150 mg bid bupropion SR~Bupropion SR: 150 encapsulated pill, 3 days 1x/day then 56 days at 2x/day, then 3 day at 1x/day ramp-down."
913999|NCT01048879|B4|Baseline|Total|Total of all reporting groups
914000|NCT01048879|B3|Baseline|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
914001|NCT01048879|B2|Baseline|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
914002|NCT01048879|B1|Baseline|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
914003|NCT01048879|P3|Participant Flow|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
914004|NCT01048879|P2|Participant Flow|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
914005|NCT01048879|P1|Participant Flow|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
914006|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
914007|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
914008|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
914009|NCT01048879|O3|Outcome|ECMO Alone|Patients receiving ECMO only
914010|NCT01048879|O2|Outcome|CVVHD + ECMO|Patients receiving oseltamivir and ECMO and CVVHD
914011|NCT01048879|O1|Outcome|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
914012|NCT01048879|E3|Reported Event|CVVHD + ECMO|Patient receiving oseltamivir and ECMO and CVVHD
914013|NCT01048879|E2|Reported Event|CVVHD Alone|Patients receiving Continuous Venovenous Hemodialysis(CVVHD) and oseltamivir
914014|NCT01048879|E1|Reported Event|ECMO Alone|Patients receiving oseltamivir and Extracorporeal Membrane Oxygenation (ECMO) therapy
914015|NCT01048788|B4|Baseline|Total|Total of all reporting groups
914016|NCT01048788|B3|Baseline|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
914017|NCT01048788|B2|Baseline|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
914018|NCT01048788|B1|Baseline|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
914019|NCT01048788|P3|Participant Flow|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
914020|NCT01048788|P2|Participant Flow|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
914021|NCT01048788|P1|Participant Flow|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
914022|NCT01048788|O3|Outcome|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
914023|NCT01048788|O2|Outcome|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
914024|NCT01048788|O1|Outcome|Discontitued/Terminated Before Day 8|Subjects who discontinued treatment before Day 7 or teiminated by meeting the criteria on Day 7
914025|NCT01048788|E3|Reported Event|Dose Escalation to 15 mg/Day|Subjects who met the criteria for dose escalation
914026|NCT01048788|E2|Reported Event|Continued Administration at 7.5 mg/Day|Subjects who did not meet the criteria for dose escalation
914027|NCT01048788|E1|Reported Event|Discontinued/Terminated Before Day8|Subjects who disconrinued treatment before Day 7 or terminated by meeting the criteria on Day 7
914244|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914028|NCT01048723|B1|Baseline|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
914029|NCT01048723|P1|Participant Flow|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
914259|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914030|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
914031|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
914032|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
914033|NCT01048723|O1|Outcome|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
914034|NCT01048723|E1|Reported Event|RAD001 Administration|RAD001 was administered orally as once daily dose of 10 mg PO daily x 2 weeks (14 X 10 mg tablets) continuously from study day 1 until the end of therapy (2 weeks later) or unacceptable toxicity.
914035|NCT01048697|B1|Baseline|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
914036|NCT01048697|P1|Participant Flow|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
914037|NCT01048697|O1|Outcome|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
914038|NCT01048697|E1|Reported Event|Ethambutol|"All volunteers received a single dose of oral ethambutol based on American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of American (ATS/CDC/IDSA) TB treatment guidelines. No doses were higher than the maximum dose recommended for daily administration by the current ATS/CDC/IDSA TB guidelines (which use ideal body weight for dosing):~40-55kg: 800 mg (two 400 mg tablets) 56-75kg: 1,200 mg (three 400 mg tablets) 76-90kg: 1,600 mg (four 400 mg tablets) > 90 kg: No dosage recommendations so these volunteers will only receive 1,600 mg (four 400 mg tablets)"
914039|NCT01048671|B4|Baseline|Total|Total of all reporting groups
914040|NCT01048671|B3|Baseline|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
914041|NCT01048671|B2|Baseline|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting. One participant in this subgroup was excluded from analysis because of protocol violation (inclusion criterion not met).
914042|NCT01048671|B1|Baseline|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914043|NCT01048671|P3|Participant Flow|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914044|NCT01048671|P2|Participant Flow|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 ribonucleic acid (RNA) copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914045|NCT01048671|P1|Participant Flow|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914046|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914047|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914245|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914246|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914048|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914260|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
920568|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
914049|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914050|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914051|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914052|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914053|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914054|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914055|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914056|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914057|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914058|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914059|NCT01048671|O4|Outcome|All Participants|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914060|NCT01048671|O3|Outcome|Virological Failure at Baseline|Virological failure participants had previous ARV experience and had a viral load >50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914061|NCT01048671|O2|Outcome|Suppressed at Baseline|Suppressed participants had previous ARV experience and had a viral load <50 RNA copies/mL at Baseline. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914062|NCT01048671|O1|Outcome|ARV naïve at Baseline|ARV naïve participants had no previous experience with ARV. Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914063|NCT01048671|O1|Outcome|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914064|NCT01048671|E1|Reported Event|Antiretroviral Combination Therapy Including Raltegravir|Participants received ARV combination treatment including raltegravir. Treatment of participants was at the discretion of the investigator who provided standard care in a real life setting.
914065|NCT01048606|B5|Baseline|Total|Total of all reporting groups
914066|NCT01048606|B4|Baseline|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
914067|NCT01048606|B3|Baseline|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914068|NCT01048606|B2|Baseline|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
914247|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914248|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914140|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914069|NCT01048606|B1|Baseline|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914070|NCT01048606|P4|Participant Flow|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
914071|NCT01048606|P3|Participant Flow|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914072|NCT01048606|P2|Participant Flow|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
914073|NCT01048606|P1|Participant Flow|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914074|NCT01048606|O4|Outcome|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
914075|NCT01048606|O3|Outcome|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914076|NCT01048606|O2|Outcome|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
914077|NCT01048606|O1|Outcome|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914078|NCT01048606|E4|Reported Event|Placebo Without Exercise|Placebo (no phytoestrogens) Without exercise (no structured exercise session) Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day).
914079|NCT01048606|E3|Reported Event|Phytoestrogens + Exercise|"Phytoestrogens (70 mg/day soy isoflavone) Exercise (1h-sessions 3 times/week)~Phytoestrogens + exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914113|NCT01048502|O3|Outcome|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914249|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914080|NCT01048606|E2|Reported Event|Phytoestrogens Without Exercise|"Phytoestrogens (70mg/day of soy isoflavone) Without exercise (no structured exercise session)~Phytoestrogens without exercise: Phytoestrogens: The phytoestrogen supplements will consist of 70 mg/day of soy isoflavones taken as 4 caps/day. More specifically, the daily dose of isoflavones contains 44 mg of diadzein, 16 mg of glycitein and 10 mg of genestein extracted from natural soy.~Without exercise: participants will be asked to do only their usual activities without being involved in any kind of structured exercise sessions."
914081|NCT01048606|E1|Reported Event|Placeco + Exercise|"Placebo (no phytoestrogen) Exercise (three 1h-sessions/week)~Placebo + exercise: Placebo: Non-active capsules of the same size and appearance than phytoestrogens capsules will be used as a placebo (same posology, i.e. 4 caps/day)~Exercise intervention: Three weekly 1h-sessions will be held on 3 non-consecutive days. Each session comprises a total of 60 min of aerobic exercise (on an ergometer device) and resistance exercise (with elastic bands, free weights, exercise ball, etc.), and a 5-min cool down. Cues regarding exercise intensity will be offered to maintain intensity in a range of 60 to 80% of maximal heart rate (with the use of a target pulse, etc.). The exercise sessions will be led by a physical activity specialist."
914082|NCT01048593|B4|Baseline|Total|Total of all reporting groups
914083|NCT01048593|B3|Baseline|Dose 3|684ug dose group
914084|NCT01048593|B2|Baseline|Dose 2|513ug dose group
914085|NCT01048593|B1|Baseline|Dose 1|114ug dose group
914086|NCT01048593|P3|Participant Flow|Dose 3|684ug dose group
914087|NCT01048593|P2|Participant Flow|Dose 2|513ug dose group
914088|NCT01048593|P1|Participant Flow|Dose 1|114ug dose group
914089|NCT01048593|O3|Outcome|Dose 3|684ug dose group
914090|NCT01048593|O2|Outcome|Dose 2|513ug dose group
914091|NCT01048593|O1|Outcome|Dose 1|114ug dose group
914092|NCT01048593|E3|Reported Event|Dose 3|684ug dose group
914093|NCT01048593|E2|Reported Event|Dose 2|513ug dose group
914094|NCT01048593|E1|Reported Event|Dose 1|114ug dose group
914095|NCT01048541|B1|Baseline|Entire Study|Includes groups randomized to standard catheter first and test catheter first
914096|NCT01048541|P2|Participant Flow|BA: First Standard Catheter Then Test Catheter|Standard catheter (SpediCath straight)used in the first period and test catheter (SpeediCath Compact Male) used in the second period
914097|NCT01048541|P1|Participant Flow|AB: First Test Catheter Then Standard Catheter|Test catheter (SpeediCath Compact Male)used in the first period and Standard catheter (SpediCath straight) used in the second period
914098|NCT01048541|O2|Outcome|Standard Catheter|Standard catheter (SpediCath straight)
914099|NCT01048541|O1|Outcome|Test Catheter|Test catheter (SpeediCath Compact Male)
914100|NCT01048541|E2|Reported Event|Standard Catheter|Standard catheter (SpediCath straight)
914101|NCT01048541|E1|Reported Event|Test Catheter|Test catheter (SpeediCath Compact Male)
914102|NCT01048502|B5|Baseline|Total|Total of all reporting groups
914103|NCT01048502|B4|Baseline|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914104|NCT01048502|B3|Baseline|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914105|NCT01048502|B2|Baseline|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
914106|NCT01048502|B1|Baseline|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
914107|NCT01048502|P4|Participant Flow|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914108|NCT01048502|P3|Participant Flow|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914109|NCT01048502|P2|Participant Flow|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
914110|NCT01048502|P1|Participant Flow|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor) tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
914111|NCT01048502|O2|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
914112|NCT01048502|O1|Outcome|Fenofibrate (Tricor) (145 mg/Day)|"Participants will be given 1 fenofibrate (Tricor) 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate (Tricor)tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
914233|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914234|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
944920|NCT00966238|O2|Outcome|1.0 µg i.m.|
914114|NCT01048502|O2|Outcome|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914115|NCT01048502|O1|Outcome|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
914116|NCT01048502|E4|Reported Event|Lovaza (3,600 mg/Day)|"Participants will be given 4 Lovaza capsules and 1 Fenofibrate placebo - supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914117|NCT01048502|E3|Reported Event|Lovaza (900 mg/Day)|"Participants will be given 1 Lovaza capsule, 3 Fish oil placebo capsules, and 1 Fenofibrate placebo – supplies of study drug will be provided to last 8 weeks.~Lovaza: 900 mg/day: One 900 mg capsule taken once daily, morning or evening; or 3,600 mg/day: Two 900 mg capsules taken twice daily, morning and evening; All capsules to be taken with food, for 6 to 8 weeks."
914118|NCT01048502|E2|Reported Event|Placebo|"Participants will be given 5 placebo pills (4 fish oil placebo and 1 Fenofibrate placebo) - supplies of study drug will be provided to last 8 weeks.~Placebo: Two placebo capsules taken twice daily, morning and evening, with food and one placebo gel capsule taken once daily, in the evening, with food, for 6 to 8 weeks"
914119|NCT01048502|E1|Reported Event|Tricor (145 mg/Day)|"Participants will be given 1 Tricor 145mg and 4 fish oil placebos - supplies of study drug will be provided to last 8 weeks.~Fenofibrate tablets: One 145 mg tablet taken once daily, in the evening, with food, for 6 to 8 weeks"
914120|NCT01048424|B3|Baseline|Total|Total of all reporting groups
914121|NCT01048424|B2|Baseline|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914122|NCT01048424|B1|Baseline|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914123|NCT01048424|P2|Participant Flow|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914124|NCT01048424|P1|Participant Flow|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914125|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914126|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914127|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914128|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914129|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914130|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914131|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914132|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914133|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914134|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914135|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914136|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914137|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914138|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914139|NCT01048424|O2|Outcome|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914235|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914141|NCT01048424|O2|Outcome|Control|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914142|NCT01048424|O1|Outcome|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914143|NCT01048424|E2|Reported Event|Usual Care|Participants will be given a pamphlet including general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914144|NCT01048424|E1|Reported Event|Paced Respiration|Participants will be instructed to practice slow-paced respiration for 15 minutes a day using the RESPeRATE device, and will also be given a pamphlet containing general information about urinary incontinence and behavioral strategies for managing incontinence symptoms.
914145|NCT01048333|B1|Baseline|Entire Study Population|Includes all 3 arms : Formoterol, Salmeterol and Placebo.
914146|NCT01048333|P6|Participant Flow|Placebo, Then Salmeterol, Then Formoterol|Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
914147|NCT01048333|P5|Participant Flow|Salmeterol, Then Formoterol, Then Placebo|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
914148|NCT01048333|P4|Participant Flow|Formoterol, Then Placebo, Then Salmeterol|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
914149|NCT01048333|P3|Participant Flow|Placebo, Then Formoterol, Then Salmeterol|Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
914150|NCT01048333|P2|Participant Flow|Salmeterol, Then Palcebo, Then Formoterol|Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
914151|NCT01048333|P1|Participant Flow|Formoterol, Then Salmeterol, Then Placebo|Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
914152|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
914153|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
914154|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
914155|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
914156|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
914157|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
914158|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
914159|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
914160|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
914161|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
914162|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
914163|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
914164|NCT01048333|O3|Outcome|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
914165|NCT01048333|O2|Outcome|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
914166|NCT01048333|O1|Outcome|Formoterol|Formoterol Turbuhaler 9 mcg
914167|NCT01048333|E3|Reported Event|Placebo|Placebo salmeterol Diskus and Placebo Turbuhaler
914168|NCT01048333|E2|Reported Event|Salmeterol|Serevent Diskus (salmeterol) 50 mcg
914169|NCT01048333|E1|Reported Event|Formoterol|Formoterol Turbuhaler 9 mcg
914170|NCT01048242|B3|Baseline|Total|Total of all reporting groups
914171|NCT01048242|B2|Baseline|Sugar Pill|
914172|NCT01048242|B1|Baseline|Ramelteon|Ramelteon 8 mg oral before bedtime
914173|NCT01048242|P2|Participant Flow|Sugar Pill|
914174|NCT01048242|P1|Participant Flow|Ramelteon|Ramelteon 8 mg oral before bedtime
914175|NCT01048242|O2|Outcome|Sugar Pill|
914176|NCT01048242|O1|Outcome|Ramelteon|Ramelteon 8 mg oral before bedtime
914177|NCT01048242|E2|Reported Event|Sugar Pill|
914178|NCT01048242|E1|Reported Event|Ramelteon|Ramelteon 8 mg oral before bedtime
914179|NCT01048125|B3|Baseline|Total|Total of all reporting groups
914180|NCT01048125|B2|Baseline|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
914181|NCT01048125|B1|Baseline|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
914182|NCT01048125|P2|Participant Flow|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
914236|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
944921|NCT00966238|O1|Outcome|0.5 µg i.m.|
914183|NCT01048125|P1|Participant Flow|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
914184|NCT01048125|O2|Outcome|Control|"Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation~Sympathetic Nerve Activity: Resting Sympathetic Nerve Activity~Mental Stress Test (Color Word Test): A printed word will be shown to the subject, displayed in a color different from the color it actually names. The subject will be asked to say the color that the word is printed in as quickly as possible. For example if the word green is written in blue ink, they will say blue. This mental stress procedure will be used to cause brief changes in heart rate and blood pressure.~The Modified Oxford Technique for Baroreflex Sensitivity: Sodium nitroprusside (100 µg) will be infused intravenously as a bolus, followed 60 seconds later by a bolus of phenylephrine hydrochloride"
914185|NCT01048125|O1|Outcome|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
914186|NCT01048125|E2|Reported Event|Control|Control subjects will be age and sex matched otherwise healthy people with no prior cardiac disease or other severe medical conditions. Sympathetic Nerve Activity; Mental Stress Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
914187|NCT01048125|E1|Reported Event|Study Group|Subjects with documented stress cardiomyopathy who would serve as the study group. Sympathetic Nerve Activity; Mental StrCold Pressor Testess Test (Color Word Test); The Modified Oxford Technique for Baroreflex Sensitivity; Cold Pressor Test; Echocardiographic evaluation
914188|NCT01048099|B1|Baseline|Patients Treated|Patients who received study treatment
914189|NCT01048099|P1|Participant Flow|All Patients|
914190|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
914191|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
914192|NCT01048099|O1|Outcome|All Patients|
914193|NCT01048099|O1|Outcome|Patients Treated|Patients who received study treatment
914194|NCT01048099|O1|Outcome|All Patients Evaluated by PRO Onc Assay|
914195|NCT01048099|E1|Reported Event|All Treated Patients|Includes all patients with HER2 overexpression/activation (as identified by the PRO Onc Assay) who received study treatment
914196|NCT01047839|B4|Baseline|Total|Total of all reporting groups
914197|NCT01047839|B3|Baseline|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
914198|NCT01047839|B2|Baseline|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
914199|NCT01047839|B1|Baseline|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m.vaccinations at Day 0 and Day 28
914200|NCT01047839|P3|Participant Flow|>=12 to <18 Years|IC51, 0.5 ml, 2 intramuscular vaccinations at Day 0 and 28
914201|NCT01047839|P2|Participant Flow|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
914202|NCT01047839|P1|Participant Flow|>=2 Months to <3 Years|IC51 0.25 ml, 2 intramuscular vaccinations at Day 0 and Day 28
914203|NCT01047839|O3|Outcome|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
914204|NCT01047839|O2|Outcome|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
914205|NCT01047839|O1|Outcome|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
914206|NCT01047839|E3|Reported Event|>=12 to <18 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
914207|NCT01047839|E2|Reported Event|>=3 to <12 Years|IC51, 0.5 ml, 2 i.m. vaccinations at Day 0 and 28
914208|NCT01047839|E1|Reported Event|>=2 Months to <3 Years|IC51 0.25 ml, 2 i.m. vaccinations at Day 0 and Day 28
914209|NCT01047709|B1|Baseline|All Study Participants|All study participants.
914210|NCT01047709|P2|Participant Flow|Control Night First, Then Positional Therapy Night|Position ad lib for the first night, then one night of avoidance of supine positioning.
914211|NCT01047709|P1|Participant Flow|Positional Therapy Night First, Then Control Night|Avoidance of supine positioning on the first night, followed by a second night of positioning ad lib.
914212|NCT01047709|O2|Outcome|Control Night|Position ad lib
914213|NCT01047709|O1|Outcome|Positional Therapy Night|Avoidance of supine positioning.
914214|NCT01047709|E2|Reported Event|Control Night|Position ad lib
914215|NCT01047709|E1|Reported Event|Positional Therapy Night|Avoidance of supine positioning.
914216|NCT01047553|B3|Baseline|Total|Total of all reporting groups
914217|NCT01047553|B2|Baseline|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914218|NCT01047553|B1|Baseline|Formoterol|Formoterol 9 μg twice daily
914219|NCT01047553|P2|Participant Flow|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914220|NCT01047553|P1|Participant Flow|Formoterol|Formoterol 9 μg twice daily
914221|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914222|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914223|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914224|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914225|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914226|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914227|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914228|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914229|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914230|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914231|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914232|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914250|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914251|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914252|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914261|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914262|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914263|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914264|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914265|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914266|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914267|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914268|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914269|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914270|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914271|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914272|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914273|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914274|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914275|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914276|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914277|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914278|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914279|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914280|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914281|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914282|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914283|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914284|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914285|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914286|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914287|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914288|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914289|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914290|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914291|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914292|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914293|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914294|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914295|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914296|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914297|NCT01047553|O2|Outcome|Arm 2 - Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914298|NCT01047553|O1|Outcome|Arm 1 - Formoterol|Formoterol 9 μg twice daily
914299|NCT01047553|E2|Reported Event|Standard Treatment|Standard COPD (JRS guideline and GOLD) treatment
914300|NCT01047553|E1|Reported Event|Formoterol|Formoterol 9 μg twice daily
914301|NCT01047527|B4|Baseline|Total|Total of all reporting groups
914302|NCT01047527|B3|Baseline|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914303|NCT01047527|B2|Baseline|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914304|NCT01047527|B1|Baseline|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914305|NCT01047527|P3|Participant Flow|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914306|NCT01047527|P2|Participant Flow|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914307|NCT01047527|P1|Participant Flow|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914308|NCT01047527|O2|Outcome|Extended + Maintenance|
914309|NCT01047527|O1|Outcome|Standard|
914310|NCT01047527|O2|Outcome|Maintenance|Participants on 52 weeks of therapy
914311|NCT01047527|O1|Outcome|Standard + Extended|participants on standard or extended therapy
914312|NCT01047527|E3|Reported Event|52 Weeks Transdermal Nicotine|"52 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914313|NCT01047527|E2|Reported Event|24 Weeks Transdermal Nicotine|"24 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
944922|NCT00966238|O6|Outcome|8.0 µg i.m.|
914314|NCT01047527|E1|Reported Event|8 Weeks Transdermal Nicotine|"8 weeks of transdermal nicotine~Transdermal nicotine patch: Transdermal nicotine, 21mg/day"
914315|NCT01047475|B3|Baseline|Total|Total of all reporting groups
914316|NCT01047475|B2|Baseline|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
914317|NCT01047475|B1|Baseline|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
914318|NCT01047475|P2|Participant Flow|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
914319|NCT01047475|P1|Participant Flow|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
914320|NCT01047475|O2|Outcome|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
914466|NCT01047293|B1|Baseline|All Patients|
914321|NCT01047475|O1|Outcome|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
914322|NCT01047475|E2|Reported Event|Placebo+FOLFOX4|"Placebo, 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~Placebo: 6# TID with meal"
914323|NCT01047475|E1|Reported Event|MB-6+FOLFOX4|"MB-6 6 capsules tid be taken with meals plus FOLFOX4, will be given for 16 weeks~MB-6: 6# TID with meal"
914324|NCT01047436|B3|Baseline|Total|Total of all reporting groups
914325|NCT01047436|B2|Baseline|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914326|NCT01047436|B1|Baseline|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914327|NCT01047436|P2|Participant Flow|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914328|NCT01047436|P1|Participant Flow|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914329|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914330|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914331|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914332|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914333|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914334|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914335|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914336|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914337|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914338|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914339|NCT01047436|O2|Outcome|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914340|NCT01047436|O1|Outcome|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914341|NCT01047436|E2|Reported Event|Intravenous Quinine|Intravenous Quinine. Loading dose of 20 mg/kg and subsequent doses of 10 mg/kg 8 hourly
914342|NCT01047436|E1|Reported Event|ArTiMist|Artemether Sublingual Spray 3 mg/kg administered at 0, 8, 24, 36, 48, and 60 hours
914343|NCT01047358|B1|Baseline|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
914344|NCT01047358|P1|Participant Flow|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
914345|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
914346|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
914347|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
914348|NCT01047358|O1|Outcome|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
914378|NCT01047332|P1|Participant Flow|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
944923|NCT00966238|O5|Outcome|5.0 µg i.m.|
914349|NCT01047358|E1|Reported Event|Aromasin|Participants were included if they had early breast cancer for adjuvant hormonal therapy or advanced breast cancer for second-line hormonal therapy after anti-estrogen therapy and were prescribed Aromasin for the first time. Aromasin was administered as part of routine care. The use and dosage recommendations for Aromasin were based on the approved local product document. Any adjustments were made solely according to medical and therapeutic necessity.
914350|NCT01047345|B3|Baseline|Total|Total of all reporting groups
914351|NCT01047345|B2|Baseline|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914352|NCT01047345|B1|Baseline|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914353|NCT01047345|P3|Participant Flow|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
914354|NCT01047345|P2|Participant Flow|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914355|NCT01047345|P1|Participant Flow|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914356|NCT01047345|O1|Outcome|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
914357|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914358|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914359|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914360|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914361|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914362|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914363|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914364|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914365|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914366|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914367|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914368|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914369|NCT01047345|O2|Outcome|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914370|NCT01047345|O1|Outcome|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914371|NCT01047345|E3|Reported Event|9vHPV Vaccine - Extension Study|Participants who received placebo in Base Study and elected to have open-label 9vHPV vaccination in Extension Study.
914372|NCT01047345|E2|Reported Event|Placebo - Base Study|Blinded 0.5 mL intramuscular injection of saline placebo at Day 1, Month 2, and Month 6 of the Base Study. After completion of the Base Study, participants will be eligible to receive open-label 9vHPV 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Extension Study.
914373|NCT01047345|E1|Reported Event|9vHPV Vaccine - Base Study|Blinded 9vHPV vaccine (V503) 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6 of the Base Study. Participants will not continue to the Extension Study.
914374|NCT01047332|B3|Baseline|Total|Total of all reporting groups
914375|NCT01047332|B2|Baseline|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
914376|NCT01047332|B1|Baseline|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
914377|NCT01047332|P2|Participant Flow|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
914379|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
914380|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
914381|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
914382|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
914383|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
914384|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
914385|NCT01047332|O2|Outcome|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
914386|NCT01047332|O1|Outcome|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
914387|NCT01047332|E2|Reported Event|Partially Covered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type).
914388|NCT01047332|E1|Reported Event|Uncovered Wallstent|Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type).
914389|NCT01047306|B3|Baseline|Total|Total of all reporting groups
914390|NCT01047306|B2|Baseline|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914391|NCT01047306|B1|Baseline|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914392|NCT01047306|P2|Participant Flow|Children ≥ 6 Years Old|Children ≥ 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
914393|NCT01047306|P1|Participant Flow|Children < 6 Years Old|Children ≥1 to < 6 years of age with Sanfilippo Syndrome Type A (mucopolysaccharidosis type IIIA; MPS IIIA) who were untreated with any investigational products (drugs and/or devices).
914394|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914395|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914396|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914397|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914398|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914399|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914400|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914401|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914402|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914403|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914404|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914405|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914406|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914407|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914408|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914409|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914410|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914411|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914412|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914413|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914414|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914415|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914416|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914417|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914418|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914419|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
944924|NCT00966238|O4|Outcome|3.0 µg i.m.|
914420|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914421|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914422|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914423|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914424|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914425|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914426|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914427|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914428|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914429|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914430|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914431|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914432|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914433|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914434|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914435|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914436|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914437|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914438|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914439|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914440|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914441|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914442|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914443|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914444|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914445|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914446|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914447|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914448|NCT01047306|O2|Outcome|Children ≥ 6 Years Old|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914449|NCT01047306|O1|Outcome|Children < 6 Years Old|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914450|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914451|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914452|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914453|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914454|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914455|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914456|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914457|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914458|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914459|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914460|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914461|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914462|NCT01047306|O2|Outcome|Children ≥ 6 Years|Children ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914463|NCT01047306|O1|Outcome|Children < 6 Years|Children ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914464|NCT01047306|E2|Reported Event|Children ≥ 6 Years|Patients ≥ 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914465|NCT01047306|E1|Reported Event|Children < 6 Years|Patients ≥1 to < 6 years of age with MPS IIIA who were untreated with any investigational products (drugs and/or devices).
914467|NCT01047293|P4|Participant Flow|ARM 4 10mg RAD001 QD - Phase II|Patients received 10 mg RAD001 with FOLFOX and bevacizumab. - Patient in the Dose Expansion Cohort not Dose Escalation
914468|NCT01047293|P3|Participant Flow|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
914469|NCT01047293|P2|Participant Flow|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
914470|NCT01047293|P1|Participant Flow|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
914471|NCT01047293|O3|Outcome|ARM 3 10mg RAD001 QD|Patients received 10mg RAD001 QD with FOLFOX and bevacizumab.
914472|NCT01047293|O2|Outcome|ARM 2 5mg RAD001 QD|Patients received 5mg RAD001 QD with FOLFOX and bevacizumab.
914473|NCT01047293|O1|Outcome|ARM 1 RAD001 5 mg QOD|Patients received 5mg RAD001 with FOLFOX and bevacizumab.
914474|NCT01047293|O1|Outcome|All Patients|
914475|NCT01047293|E1|Reported Event|All Patients|All participants enrolled.
914476|NCT01047241|B1|Baseline|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
914477|NCT01047241|P1|Participant Flow|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
914478|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
914479|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
914480|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
914481|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing sufentanil/ketamine. Dose sufentanil 0.5 mcg/kg and ketamine 0.5 mg/kg, single dose.
914482|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose Pharmacokinetic analysis: 13 children enrolled
914483|NCT01047241|O1|Outcome|Intranasal Sufentanil/Ketamine|Sufentanil/ketamine: Nasal spray containing a combination of sufentanil and ketamine. Dose sufentanil 0.5 micg/kg and ketamine 0.5 mg/kg, single dose
914484|NCT01047241|E1|Reported Event|Intranasal Sufentanil+Ketamine|Sufentanil, ketamine: Nasal spray sufentanil+ketamine, single dose
914485|NCT01047189|B3|Baseline|Total|Total of all reporting groups
914486|NCT01047189|B2|Baseline|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
914487|NCT01047189|B1|Baseline|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
914488|NCT01047189|P2|Participant Flow|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
914489|NCT01047189|P1|Participant Flow|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
914490|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
914491|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
914492|NCT01047189|O2|Outcome|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
914493|NCT01047189|O1|Outcome|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
914494|NCT01047189|E2|Reported Event|Clindamycin Plus Tretinoin Applied Separately|Generic clindamycin 1% gel plus tretinoin 0.025% cream
914495|NCT01047189|E1|Reported Event|Ziana Gel|Ziana gel (clindamycin phosphate 1.2% and tretinoin 0.025%) applied once daily for 12 weeks
914496|NCT01046903|B1|Baseline|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914497|NCT01046903|P1|Participant Flow|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 International Unit (IU)/0.2 milliliter (mL) and 5000 IU/2 mL subcutaneously (s.c) as per registered indications for 5 weeks.
914498|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914499|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914500|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914501|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914502|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914503|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914504|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
944925|NCT00966238|O3|Outcome|2.0 µg i.m.|
914505|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914506|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914507|NCT01046903|O1|Outcome|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914508|NCT01046903|E1|Reported Event|Dalteparin Sodium|Dalteparin Sodium (Fragmin) 2500 IU/0.2 mL and 5000 IU/2 mL s.c as per registered indications for 5 weeks.
914509|NCT01046877|B1|Baseline|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
915047|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
914510|NCT01046877|P1|Participant Flow|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914511|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914512|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914513|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914514|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914515|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914516|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914517|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914518|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914519|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914520|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914521|NCT01046877|O1|Outcome|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914522|NCT01046877|E1|Reported Event|Tympanic Tube Placement|"Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).~Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)"
914523|NCT01046695|B3|Baseline|Total|Total of all reporting groups
914524|NCT01046695|B2|Baseline|Control Arm|This arm will have standard care for their post operative pain control.
914525|NCT01046695|B1|Baseline|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
914526|NCT01046695|P2|Participant Flow|TENS Unit|Once awake from surgery this arm added the use of the TENS unit for 48 hours in addition to standard care for their postoperative pain control. The TENS unit was set to each patients individual preference which included intensity, frequency and the placement of where they wanted the electrodes.
914527|NCT01046695|P1|Participant Flow|Control Arm|Once awake from surgery this arm had standard care for 48 hours for their postoperative pain control using each surgeons usual postoperative medications and procedures.
914528|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
914529|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
914530|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
914558|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
914531|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
914532|NCT01046695|O2|Outcome|Control Arm|This arm will have standard care for their post operative pain control.
914533|NCT01046695|O1|Outcome|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
914534|NCT01046695|E2|Reported Event|Control Arm|This arm will have standard care for their post operative pain control.
914535|NCT01046695|E1|Reported Event|TENS Unit|"This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.~Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation."
914536|NCT01046682|B3|Baseline|Total|Total of all reporting groups
914537|NCT01046682|B2|Baseline|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
914538|NCT01046682|B1|Baseline|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
914539|NCT01046682|P2|Participant Flow|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
914540|NCT01046682|P1|Participant Flow|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
914541|NCT01046682|O2|Outcome|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
914542|NCT01046682|O1|Outcome|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
914543|NCT01046682|E2|Reported Event|Usual Care|No placebo tablet was used in the study. Participants randomized to usual care received all of the study evaluations that the salsalate group did; however, no study medication was administered.
914544|NCT01046682|E1|Reported Event|Salsalate|Salsalate 2 grams by mouth twice a day for a total daily dosage of 4 grams daily. Salsalate administered in 500 mg tablets. If 4 grams daily not tolerated by the participant, whatever dose up to 4 grams daily was tolerated was continues through the study.
914545|NCT01046643|B3|Baseline|Total|Total of all reporting groups
914546|NCT01046643|B2|Baseline|Progesterone and Placebo|"Progesterone treatment (P10)~Participants received both a Progesterone capsule (P10) (200 mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
914547|NCT01046643|B1|Baseline|Estrogen and Placebo|"Estrogen treatment with Estradiol (E2)~Participants received both an Estradiol capsule (E2) (1mg) and a Placebo capsule in a randomized sequence (for a total of two sequences of 90 days each, consisting of one capsule, once per day at the same time each day)."
914548|NCT01046643|P4|Participant Flow|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
914549|NCT01046643|P3|Participant Flow|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days.
914550|NCT01046643|P2|Participant Flow|Progesterone Followed by Placebo|"Progesterone (P10) treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
914551|NCT01046643|P1|Participant Flow|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day"
914552|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
914553|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
916077|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
914554|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
914555|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
914556|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
914557|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
915048|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
914559|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
914560|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
914561|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
914562|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
914563|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
914564|NCT01046643|O4|Outcome|Placebo (Progesterone)|"Placebo phase of Progesterone (P10) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
914565|NCT01046643|O3|Outcome|Placebo (Estrogen)|"Placebo phase of Estradiol (E2) treatment~One Placebo capsule once a day, at the same time each day, for 90 days"
914566|NCT01046643|O2|Outcome|Progesterone|"Progesterone treatment~Progesterone (P10) : One Progesterone (200 mg) capsule once a day, at the same time each day, for 90 days"
914567|NCT01046643|O1|Outcome|Estrogen|"Estrogen treatment with Estradiol (E2)~Estradiol (E2) : One Estradiol capsule (1mg) once a day, at the same time each day, for 90 days"
914568|NCT01046643|E4|Reported Event|Placebo Followed by Progesterone|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days.
914569|NCT01046643|E3|Reported Event|Placebo Followed by Estrogen|One Placebo capsule once per day for 90 days, at the same time each day, followed by one Estradiol capsule (E2) (1mg) capsule once a day, at the same time each day, for 90 days.
914570|NCT01046643|E2|Reported Event|Progesterone Followed by Placebo|"Progesterone treatment~One Progesterone (P10) (200 mg) capsule once a day, at the same time each day, for 90 days, followed by one Placebo capsule once per day for 90 days, at the same time each day."
914571|NCT01046643|E1|Reported Event|Estrogen Followed by Placebo|"Estrogen treatment with Estradiol (E2)~One Estradiol capsule (E2) (1mg) once a day, at the same time each day, for 90 days followed by one Placebo capsule once per day for 90 days, at the same time each day."
914572|NCT01046565|B1|Baseline|Differin® Lotion 0.1% and Differin Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
914573|NCT01046565|P1|Participant Flow|Differin® Lotion 0.1% and Differin® Cream 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Adapalene Cream - apply topically to the opposite site of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
914574|NCT01046565|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
914575|NCT01046565|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks
914576|NCT01046565|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
914577|NCT01046565|O2|Outcome|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
914578|NCT01046565|O1|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
914579|NCT01046565|E2|Reported Event|Differin Cream 0.1%|Adapalene Cream 0.1% - apply topically to the opposite side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
914580|NCT01046565|E1|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply topically to one side of the face once daily for 3 weeks. Subjects were randomized to receive Adapalene Cream 0.1% on one side of the face and Adapalene Lotion 0.1% on the other side of the face.
914581|NCT01046396|B1|Baseline|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
914582|NCT01046396|P1|Participant Flow|Differin® Cream 0.1% and Differin® Lotion 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks; Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
914583|NCT01046396|O3|Outcome|No Preference|Neither Differin® Cream 0.1% nor Differin® Lotion 0.1%
914584|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
914585|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
914586|NCT01046396|O2|Outcome|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
914587|NCT01046396|O1|Outcome|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
914588|NCT01046396|E2|Reported Event|Differin® Lotion 0.1%|Adapalene Lotion 0.1% - apply to the opposite side of the face for 3 weeks
944926|NCT00966238|O2|Outcome|1.0 µg i.m.|
914589|NCT01046396|E1|Reported Event|Differin® Cream 0.1%|Adapalene Cream 0.1% - apply topically to one side of the face once daily for 3 weeks
914590|NCT01046253|B3|Baseline|Total|Total of all reporting groups
914591|NCT01046253|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
914592|NCT01046253|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
914678|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914593|NCT01046253|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
914594|NCT01046253|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
914595|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
914596|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
914597|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
914598|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
914599|NCT01046253|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
914600|NCT01046253|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
914601|NCT01046253|E2|Reported Event|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third period followed by 30 mg Lansoprazole Delayed-Release Capsules test product dosed in the second and fourth period.
914602|NCT01046253|E1|Reported Event|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 30 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
914603|NCT01046136|B3|Baseline|Total|Total of all reporting groups
914604|NCT01046136|B2|Baseline|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
914605|NCT01046136|B1|Baseline|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
914606|NCT01046136|P2|Participant Flow|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
914607|NCT01046136|P1|Participant Flow|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
914608|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
914609|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
914610|NCT01046136|O2|Outcome|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
914611|NCT01046136|O1|Outcome|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
914612|NCT01046136|O2|Outcome|Placebo|Two placebo tablets, identical in appearance to active treatment, taken taken twice daily
914613|NCT01046136|O1|Outcome|Mucinex|Two 600mg tablets taken taken twice daily
914614|NCT01046136|E2|Reported Event|Placebo|2 TABLETS EVERY 12 HOURS FOR 7 DAYS
914615|NCT01046136|E1|Reported Event|Mucinex|2 X 600 MG TABLETS EVERY 12 HOURS FOR 7 DAYS
914616|NCT01046110|B3|Baseline|Total|Total of all reporting groups
914617|NCT01046110|B2|Baseline|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
914618|NCT01046110|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
914619|NCT01046110|P2|Participant Flow|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
914620|NCT01046110|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
914621|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
914622|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
914623|NCT01046110|O2|Outcome|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
914624|NCT01046110|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
914625|NCT01046110|E2|Reported Event|DPP-IV Inhibitor|Sitagliptin was given once daily dose of 100 mg for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination.
914626|NCT01046110|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily subcutaneously (s.c.) for 26 weeks with pre-trial treatment being 1 or 2 oral anti-diabetic drugs (metformin, sulfonylureas, glinides, pioglitazone) in any combination. Variation in injection time from day to day was allowed (minimum 8 hours and maximum 40 hours between injections).
914627|NCT01046084|B3|Baseline|Total|Total of all reporting groups
914672|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914628|NCT01046084|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
914629|NCT01046084|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
914676|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914630|NCT01046084|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® Capsules reference product dosed in first and third periods followed by 30 mg Lansoprazole Capsules test product dosed in the second and fourth periods.
914631|NCT01046084|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole Delayed-Release Capsules test product dosed in first and third periods followed by 500 mg Prevacid® Capsules reference product dosed in the second and fourth periods.
914632|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
914633|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
914634|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
914635|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
914636|NCT01046084|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
914637|NCT01046084|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
914638|NCT01046084|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® Capsules reference product dosed in any period.
914639|NCT01046084|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole Delayed-Release Capsules test product dosed in any period.
914640|NCT01045993|B5|Baseline|Total|Total of all reporting groups
914641|NCT01045993|B4|Baseline|Oral Placebo|Oral Placebo matching Oral IBU.
914642|NCT01045993|B3|Baseline|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914643|NCT01045993|B2|Baseline|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914644|NCT01045993|B1|Baseline|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914645|NCT01045993|P4|Participant Flow|Oral Placebo|Oral Placebo matching Oral IBU.
914646|NCT01045993|P3|Participant Flow|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914647|NCT01045993|P2|Participant Flow|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914648|NCT01045993|P1|Participant Flow|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914649|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914650|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914651|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914652|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914653|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914654|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914655|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914656|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914657|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914658|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914659|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914660|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914661|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914662|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914663|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914664|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914665|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914666|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914667|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914668|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914669|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914670|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914671|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914673|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914674|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914675|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914677|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914679|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914680|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914681|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914682|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914683|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914684|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914685|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914686|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914687|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914688|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914689|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914690|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914691|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914692|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914693|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914694|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914695|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914696|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914697|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914698|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914699|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914700|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914701|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914702|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914703|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914704|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914705|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914706|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914707|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914708|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914709|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914710|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914711|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914712|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914713|NCT01045993|O4|Outcome|Oral Placebo|Oral Placebo matching Oral IBU.
914714|NCT01045993|O3|Outcome|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914715|NCT01045993|O2|Outcome|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914716|NCT01045993|O1|Outcome|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914717|NCT01045993|E4|Reported Event|Oral Placebo|Oral Placebo matching Oral IBU.
914718|NCT01045993|E3|Reported Event|Oral Ibuprofen (IBU)|IBU (commercially available Advil®) administered as two 200 milligram (mg) tablets by mouth (PO) as a one time dose.
914719|NCT01045993|E2|Reported Event|Sham Wrap (Inactive)|Inactive heatwrap administered one time as a non-heating wrap; applied within 5 minutes of unsealing the foil wrapper.
914720|NCT01045993|E1|Reported Event|ThermaCare®|Active treatment low back/hip heatwrap administered one time (could be applied for up to 8 hours); applied within 5 minutes of unsealing the foil wrapper.
914721|NCT01045967|B3|Baseline|Total|Total of all reporting groups
914722|NCT01045967|B2|Baseline|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
915049|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
914723|NCT01045967|B1|Baseline|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
914724|NCT01045967|P2|Participant Flow|Reference (Prevacid®) First|30 mg Prevacid® DR Capsules reference product dosed in first period followed by 30 mg Lansoprazole DR Capsules test product dosed in the second period.
914725|NCT01045967|P1|Participant Flow|Test (Lansoprazole) First|30 mg Lansoprazole DR Capsules test product dosed in first period followed by 30 mg Prevacid® DR Capsules reference product dosed in the second period.
914726|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
914727|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
914728|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
914729|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
914730|NCT01045967|O2|Outcome|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
914731|NCT01045967|O1|Outcome|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
914732|NCT01045967|E2|Reported Event|Reference (Prevacid®)|30 mg Prevacid® DR Capsules reference product dosed in either period.
914733|NCT01045967|E1|Reported Event|Test (Lansoprazole)|30 mg Lansoprazole DR Capsules test product dosed in either period.
914734|NCT01045798|B3|Baseline|Total|Total of all reporting groups
914735|NCT01045798|B2|Baseline|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
914736|NCT01045798|B1|Baseline|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
914737|NCT01045798|P2|Participant Flow|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
914738|NCT01045798|P1|Participant Flow|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
914739|NCT01045798|O2|Outcome|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
914740|NCT01045798|O1|Outcome|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
914741|NCT01045798|E2|Reported Event|Placebo|Placebo to caspofungin (normal saline) on Day 1 followed by placebo daily for at least 6 additional days (maximum duration study therapy is 14 days)
914742|NCT01045798|E1|Reported Event|Caspofungin|Caspofungin 70 mg caspofungin administered intravenously (IV) on Day 1 followed by 50 mg daily for at least 6 additional days (maximum duration study therapy is 14 days)
914743|NCT01045707|B3|Baseline|Total|Total of all reporting groups
914744|NCT01045707|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
914745|NCT01045707|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914746|NCT01045707|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
914747|NCT01045707|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914748|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
914749|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914750|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
914751|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914752|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
944927|NCT00966238|O1|Outcome|0.5 µg i.m.|
914753|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914754|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
920569|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
914755|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914756|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
914757|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914758|NCT01045707|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
914759|NCT01045707|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914760|NCT01045707|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
914761|NCT01045707|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
914762|NCT01045551|B1|Baseline|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
914763|NCT01045551|P1|Participant Flow|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
914764|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
914765|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
914766|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
914767|NCT01045551|O1|Outcome|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
914768|NCT01045551|O1|Outcome|Open Label Apremilast 20 mg (Twice Per Day)|"This is an open label study, therefore all subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks"
914769|NCT01045551|E1|Reported Event|Apremilast 20 mg (Twice Per Day)|"All subjects will receive Apremilast 20mg taken orally twice per day.~Apremilast: 20mg taken orally twice per day for 12 weeks~The most frequently reported adverse event (AE) was infection. One patient (a 74 year old female) experienced 2 urinary tract infections during the course of the study, and another (a 63 year old female) experienced one urinary tract infection. Two patients experienced upper respiratory infections, which have previously been reported in patients taking apremilast. The second most common AE was loose stool, reported by two patients, which resolved quickly and without recurrence. All AE’s were reported as mild and no patient withdrew from the study due to AEs. No patient required dosing modification or discontinuation."
914770|NCT01045447|B3|Baseline|Total|Total of all reporting groups
914771|NCT01045447|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
914772|NCT01045447|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
914773|NCT01045447|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
914774|NCT01045447|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
914775|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
914776|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
914777|NCT01045447|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
914778|NCT01045447|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
916078|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
914779|NCT01045447|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously according to approved labelling in combination with metformin±pioglitazone±DPP-4. inhibitor.
914780|NCT01045447|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given once daily (OD) subcutaneously (s.c.) with main evening meal or the largest meal of the day in combination with metformin±pioglitazone±DPP-4 inhibitor.
914781|NCT01045421|B7|Baseline|Total|Total of all reporting groups
920570|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
914782|NCT01045421|B6|Baseline|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914783|NCT01045421|B5|Baseline|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914784|NCT01045421|B4|Baseline|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914785|NCT01045421|B3|Baseline|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914786|NCT01045421|B2|Baseline|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914787|NCT01045421|B1|Baseline|Phase 1: MLN8237- All Participants|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose-escalation or pancreatic cancer cohort during Phase 1 portion of the study.
914788|NCT01045421|P11|Participant Flow|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914789|NCT01045421|P10|Participant Flow|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914790|NCT01045421|P9|Participant Flow|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914791|NCT01045421|P8|Participant Flow|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914792|NCT01045421|P7|Participant Flow|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914793|NCT01045421|P6|Participant Flow|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
914794|NCT01045421|P5|Participant Flow|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914795|NCT01045421|P4|Participant Flow|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914796|NCT01045421|P3|Participant Flow|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914797|NCT01045421|P2|Participant Flow|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914798|NCT01045421|P1|Participant Flow|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
915050|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
914799|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914800|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914801|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914802|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914803|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914804|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914805|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
914806|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914807|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914808|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914809|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914810|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
914811|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914812|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914813|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914814|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914833|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914834|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914815|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
914816|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914817|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914818|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914819|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914820|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
914821|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914822|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914823|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914824|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914825|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
914826|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914827|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914828|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914829|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914830|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
914831|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914832|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914835|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg (Including Pancreatic Cancer)|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study. Included participants from dose-escalation cohort or pancreatic cancer cohort who received alisertib 50 mg twice daily.
914836|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914837|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914838|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914839|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914840|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914841|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914842|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914843|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914844|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914845|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914846|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914847|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914848|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914849|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914850|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
915042|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
914868|NCT01045421|O2|Outcome|Phase 1: MLN8237 20 mg|MLN8237 (alisertib) 20 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914851|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914852|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914853|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914854|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914855|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914856|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914857|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914858|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914859|NCT01045421|O5|Outcome|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914860|NCT01045421|O4|Outcome|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914861|NCT01045421|O3|Outcome|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914862|NCT01045421|O2|Outcome|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914863|NCT01045421|O1|Outcome|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914864|NCT01045421|O6|Outcome|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
914865|NCT01045421|O5|Outcome|Phase 1: MLN8237 60 mg|MLN8237 (alisertib) 60 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914866|NCT01045421|O4|Outcome|Phase 1: MLN8237 50 mg|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914867|NCT01045421|O3|Outcome|Phase 1: MLN8237 40 mg|MLN8237 (alisertib) 40 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
915043|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
915044|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
914869|NCT01045421|O1|Outcome|Phase 1: MLN8237 10 mg|MLN8237 (alisertib) 10 milligram (mg), enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy during Phase 1 portion of the study.
914870|NCT01045421|E7|Reported Event|Phase 2: MLN8237 50 mg- SCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with small cell lung cancer (SCLC) during Phase 2 portion of the study.
914871|NCT01045421|E6|Reported Event|Phase 2: MLN8237 50 mg- NSCLC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with non-small cell lung cancer (NSCLC) during Phase 2 portion of the study.
914872|NCT01045421|E5|Reported Event|Phase 2: MLN8237 50 mg- HNSCC|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with head and neck squamous cell carcinoma (HNSCC) during Phase 2 portion of the study.
914873|NCT01045421|E4|Reported Event|Phase 2: MLN8237 50 mg- Gastric Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with gastric cancer during Phase 2 portion of the study.
914874|NCT01045421|E3|Reported Event|Phase 2: MLN8237 50 mg- Breast Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with breast cancer during Phase 2 portion of the study.
914875|NCT01045421|E2|Reported Event|Phase 1: MLN8237 50 mg- Pancreatic Cancer|MLN8237 (alisertib) 50 mg, enteric-coated tablets, orally, twice daily for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants with pancreatic cancer during Phase 1 portion of the study.
914876|NCT01045421|E1|Reported Event|Phase 1: MLN8237- Dose Escalation|MLN8237 (alisertib) 10, 20, 30, 40, 50, or 60 mg enteric-coated tablets, orally, twice daily, for 7 days followed by 14 days of rest period in 21-day treatment cycles for a maximum of 24 months, or until progressive disease, unacceptable treatment-related toxicity, or initiation of a different anticancer therapy in participants enrolled in dose escalation cohort during Phase 1 portion of the study.
914877|NCT01045265|B1|Baseline|Men on Raltegravir|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
914878|NCT01045265|P1|Participant Flow|Men on Raltegravir|HIV-infected men on chronic therapy with raltegravir 400 mg per day as part of antiretroviral therapy regimen.
914879|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
914880|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
914881|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
914882|NCT01045265|O1|Outcome|16 Male HIV-positive Patients|Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of raltegravir in semen, the variability in penetration of raltegravir into the seminal compartment over the dosing period.
914883|NCT01045265|E1|Reported Event|Men on Raltegravir|HIV-infected men receiving chronic therapy with raltegravir 400 mg per day as part of antiretroviral regimen.
914884|NCT01045187|B1|Baseline|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
914885|NCT01045187|P1|Participant Flow|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
914886|NCT01045187|O1|Outcome|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
914887|NCT01045187|E1|Reported Event|Endometrial Cancer|Patients are treated with electronic brachytherapy for an FDA cleared indication.
914888|NCT01045161|B4|Baseline|Total|Total of all reporting groups
914889|NCT01045161|B3|Baseline|Aclidinium Bromide(AB) 400μg Part A / AB 400μg to 400μg Part B|"Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks."
914996|NCT01044771|O1|Outcome|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients~change from tenofovir to raltegravir: Change of the tenofovir based nucleoside part of the HIV regimen to raltegravir, 400mg BID"
944928|NCT00966238|E6|Reported Event|8.0 µg i.m.|
915000|NCT01044732|B1|Baseline|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
920571|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
914890|NCT01045161|B2|Baseline|Aclidinium Bromide(AB) 200μg Part A / AB 200μg to 400μg Part B|"Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks."
914891|NCT01045161|B1|Baseline|Placebo Part A / Placebo to Aclidinium Bromide 400μg Part B|"Dose-matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment in Part A of the Trial.~After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks."
914892|NCT01045161|P3|Participant Flow|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients continued to receive Aclidinium bromide, 400 microgram dose as an open-label treatment for an additional 40 weeks
914893|NCT01045161|P2|Participant Flow|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment. After 12 weeks, patients who were Aclidinium bromide 200 microgram dose, received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
914894|NCT01045161|P1|Participant Flow|Placebo - Part A Placebo to Aclidinium Bromide 400 μg - Part B|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment. After 12 weeks, patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
914895|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 400 μg dose, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 400 μg switched to open label 400µg aclidinium bromide for 40 weeks
914896|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide 200 μg, oral inhalation twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg switched to open label 400µg aclidinium bromide for 40 weeks
914897|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation twice per day for 12 weeks. At week 12, patients who were on placebo switched to open label 400µg aclidinium bromide for 40 weeks
914898|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients received open label 400µg aclidinium bromide for 40 additional weeks
914899|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 200 μg dose, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on Aclidinium bromide 200 μg were switched to open label 400µg aclidinium bromide for 40 weeks.
914900|NCT01045161|O1|Outcome|Placebo - Aclidinium Bromide 400 μg|Dose matched placebo, oral inhalation, twice per day for 12 weeks of treatment. At week 12, patients who were on placebo were switched to open label 400µg aclidinium bromide for 40 weeks
914901|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
914902|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
914903|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
914904|NCT01045161|O3|Outcome|Aclidinium Bromide 400 μg|Inhaled Aclidinium bromide 400 μg twice per day for 12 weeks.
914905|NCT01045161|O2|Outcome|Aclidinium Bromide 200 μg|Aclidinium bromide 200 μg dose twice per day, inhaled for 12 weeks of treatment.
914906|NCT01045161|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment.
914907|NCT01045161|E6|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg - Part B|After week 12 (conclusion of Part A), patients who were on a double-blind, 400 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at the same 400 microgram dose for an additional 40 weeks.
914908|NCT01045161|E5|Reported Event|Aclidinium Bromide 200μg to Aclidinium Bromide 400μg - Part B|Part B - After week 12 (conclusion of Part A), patients who were on a double-blind, 200 microgram Aclidinium Bromide dose, were switched to open-label Aclidinium Bromide at a 400 microgram dose for an additional 40 weeks.
914909|NCT01045161|E4|Reported Event|Placebo to Aclidinium Bromide 400 μg - Part B|After week 12 (conclusion of Part A), patients who were on placebo received open-label Aclidinium Bromide, 400 microgram dose, for an additional 40 weeks.
914910|NCT01045161|E3|Reported Event|Aclidinium Bromide 400 μg - Part A|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 12 weeks of double-blind treatment.
914911|NCT01045161|E2|Reported Event|Aclidinium Bromide 200 μg - Part A|Aclidinium bromide 200 microgram dose, oral inhalation, twice per day for 12 weeks of double-blind treatment.
914912|NCT01045161|E1|Reported Event|Placebo - Part A|Dose matched placebo, twice per day, oral inhalation for 12 weeks of double-blind treatment.
914913|NCT01045122|B1|Baseline|Propofol vs Dexmedetomidine|We aim to study two commonly used sedatives (propofol vs dexmedetomidine) in subjects with OSA for their propensity to produce sedation related respiratory events
914914|NCT01045122|P2|Participant Flow|Dexmedetomidine First|Dexmedetomidine was administered on the first day in 6/11 subjects with at least a one week washout between runs before the subjects underwent the experiment with propofol.
914915|NCT01045122|P1|Participant Flow|Propofol First|Propofol was administered first in 5/11 subjects with a one week washout at least between the next run with dexmedetomidine
914916|NCT01045122|O2|Outcome|Dexmedetomidine|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
914917|NCT01045122|O1|Outcome|Propofol|The respiratory disturbance index and airway closing pressures (Pcrit) were quantified for both arms
914918|NCT01045122|E2|Reported Event|Dexmedetomidine|"Dexmedetomidine is an alpha-2 adrenoreceptor agonist that has sedative, hypnotic, and analgesic effects.~Dexmedetomidine: For dexmedetomidine, an intravenous loading dose of 0.5 mcg/kg will be infused over 10 minutes and followed by an infusion starting at 0.5 mcg/kg/hr. This infusion will be titrated up to a maximum of 1.2 mcg/kg/hr."
914997|NCT01044771|E1|Reported Event|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
914998|NCT01044732|B3|Baseline|Total|Total of all reporting groups
914919|NCT01045122|E1|Reported Event|Propofol|"Is an alkylphenol, is primarily indicated for use as a general anesthetic and has minimal analgesic properties.~Propofol: For propofol, the current study will employ the Marsh parameters, with an initial effect site target concentration of 1.0 mcg/ml, a level likely to produce only mild sedation. Though our patient population is expected to be predominantly obese, a previous pharmacokinetic study has validated that constant infusions utilizing the dosing scheme of mcg-1•kg-1•min will yield similar effect site concentrations.25 The effect site target will be increased in increments approximately every five minutes until the pharmacodynamic targets defined in the study are attained."
914920|NCT01045096|B4|Baseline|Total|Total of all reporting groups
914921|NCT01045096|B3|Baseline|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914922|NCT01045096|B2|Baseline|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914923|NCT01045096|B1|Baseline|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914924|NCT01045096|P3|Participant Flow|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914925|NCT01045096|P2|Participant Flow|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914926|NCT01045096|P1|Participant Flow|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914927|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914928|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914929|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914930|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914931|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914932|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914933|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914934|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914935|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914936|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914937|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914938|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914939|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914940|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914941|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914942|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914943|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914944|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914945|NCT01045096|O3|Outcome|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914946|NCT01045096|O2|Outcome|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914947|NCT01045096|O1|Outcome|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914948|NCT01045096|E3|Reported Event|Dexlansoprazole 60 mg QD|Dexlansoprazole 60 mg, delayed release capsules, orally, once daily for up to 7 days
914949|NCT01045096|E2|Reported Event|Dexlansoprazole 30 mg QD|Dexlansoprazole 30 mg, delayed release capsules, orally, once daily for up to 7 days
914950|NCT01045096|E1|Reported Event|Dexlansoprazole 15 mg QD|Dexlansoprazole 15 mg, delayed release capsules, orally, once daily for up to 7 days.
914951|NCT01045057|B1|Baseline|Provox Vega Puncture Set|Group of larynx cancer patients undergoing a total laryngectomy whereby the puncture and placement of the voice prosthesis is done with the Provox Vega Puncture Set
914952|NCT01045057|P1|Participant Flow|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Vega Puncture Set
914953|NCT01045057|O1|Outcome|Secondary Puncture|Patients who had a secondary puncture
914954|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
914955|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
914956|NCT01045057|O1|Outcome|Provox Vega Puncture Set|Patients in whom a voice prosthesis was placed by means of the Provox Vega Puncture Set
914957|NCT01045057|E1|Reported Event|Provox Vega Puncture Set|Group of larynx cancer patients undergoing laryngectomy whereby the puncture and the placement of the voice prosthesis is done with the Provox Vega Puncture set
914958|NCT01045031|B3|Baseline|Total|Total of all reporting groups
914959|NCT01045031|B2|Baseline|Controls|The control group was matched according to age, sex and years of education.
914960|NCT01045031|B1|Baseline|Marathon Athletes|Participation in more than one of the following competitions during the previous three years: Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km)
915045|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
914961|NCT01045031|P2|Participant Flow|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
914962|NCT01045031|P1|Participant Flow|Controls|The control group was matched according to age, sex and years of education.
914963|NCT01045031|O2|Outcome|Marathon Athletes|Runners participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km). Inclusion criteria:1) participation in at least one of these 3 marathons in the preceding two years,2)still in continuous training during the recruitment phase (at least 2 hours/week), 3) aged over 60. Exclusion criteria:(a) present or past exposure to neurotoxic substances (b) if they did not speak German as their native language (c) diseases that markedly affect CNS functions (d) manifest cardiovascular disease, (e) chronic alcoholism (daily alcohol intake > 60 g or diagnosed history of alcoholism) and (f) unwillingness to give informed consent.
914964|NCT01045031|O1|Outcome|Controls|Controls were subsequently contacted via personal contact and three additional advertisements (two in an Austrian newspaper (“Krone”) and one in an Austrian bicyclist journal (“Bicyclist Sports”). The controls were matched according to age, sex and years of education
914965|NCT01045031|O2|Outcome|Marathon Athletes|"Runners and bicyclists participating in the 2008 Wachau half marathon (21,2 km) and the Vienna City marathon (42,5 km) as well as bicyclists participating at the Corinthian marathon (180km) were recruited.~The inclusion criteria were~(1) participation in at least one of these 3 marathons in the preceding two years, (2) were still in continuous training during the recruitment phase (at least 2 hours/week) and (3) were over the age of 60."
914966|NCT01045031|O1|Outcome|Controls|The control group was matched according to age, sex and years of education.
914967|NCT01045031|O2|Outcome|Controls|Brain-derived Neurotrophic Factor (BDNF)
914968|NCT01045031|O1|Outcome|Marathon Athletes|Brain-derived Neurotrophic Factor (BDNF)
914969|NCT01045031|E2|Reported Event|Athletes|
914970|NCT01045031|E1|Reported Event|Controls|
914971|NCT01044862|B4|Baseline|Total|Total of all reporting groups
914972|NCT01044862|B3|Baseline|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
914973|NCT01044862|B2|Baseline|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
914974|NCT01044862|B1|Baseline|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
914975|NCT01044862|P3|Participant Flow|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
914976|NCT01044862|P2|Participant Flow|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
914977|NCT01044862|P1|Participant Flow|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
914978|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
914979|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
914999|NCT01044732|B2|Baseline|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
915557|NCT01042678|B3|Baseline|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
914980|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
914981|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
914982|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
914983|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
914984|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
914985|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
914986|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
914987|NCT01044862|O3|Outcome|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
914988|NCT01044862|O2|Outcome|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
914989|NCT01044862|O1|Outcome|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
914990|NCT01044862|E3|Reported Event|Follicle Stimulating Hormone (FSH)|"A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used.~Follicle Stimulating Hormone (gonadotropin): A daily injection of 150 IU of FSH will be administered subcutaneously starting on day three of the menstrual cycle and continuing until the day of hCG administration. Dosage will be able to be increased or decreased 37.5-75 IU/d beginning cycle day 7. Future cycles can be started at doses ranging from 75-225 IU/d. The same type of FSH injections will be used."
914991|NCT01044862|E2|Reported Event|Clomiphene Citrate (CC)|"CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d.~Clomiphene Citrate: CC will be administered at a dose of 100 mg/d on cycle days 3-7. Future cycles can be started at 50-150 mg/d."
914992|NCT01044862|E1|Reported Event|Aromatase Inhibitors (AI)|"A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained.~Letrozole (aromatase inhibitor): A daily dose of 5 mg of the AI, letrozole, will be administered orally for five days starting on day three of the menstrual cycle. Future cycles can be started at 2.5-7.5 mg/d. FDA approval (IND) will be obtained."
914993|NCT01044771|B1|Baseline|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients"
914994|NCT01044771|P1|Participant Flow|Change From Tenofovir to Raltegravir|"Single arm study:~Tenofovir containing nucleoside backbone changed over to raltegravir in all patients Tenovovir 300mg was replaced with Raltegravir 400mg twice a day"
914995|NCT01044771|O1|Outcome|Viral Rebound|Every participant in the study switched to the investigational strategy
915001|NCT01044732|P2|Participant Flow|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
915002|NCT01044732|P1|Participant Flow|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
915003|NCT01044732|O2|Outcome|All TEC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during Third Eye colonoscopies (TEC)
915004|NCT01044732|O1|Outcome|All SC Procedures|For all subjects in study (i.e., Group A and Group B combined), mean times for withdrawal phase and for total procedure during standard colonoscopies (SC)
915005|NCT01044732|O2|Outcome|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
915006|NCT01044732|O1|Outcome|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
915007|NCT01044732|E2|Reported Event|Group B - TEC Followed by SC|"Third Eye colonoscopy (TEC) followed by standard colonoscopy (SC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
915008|NCT01044732|E1|Reported Event|Group A - SC Followed by TEC|"Standard colonoscopy (SC) followed by Third Eye colonoscopy (TEC)~Third Eye colonoscopy: Examination of the colon with a Third Eye Retroscope used in combination with a colonoscope to provide second, retrograde view of the colon"
915009|NCT01044706|B3|Baseline|Total|Total of all reporting groups
915010|NCT01044706|B2|Baseline|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
915011|NCT01044706|B1|Baseline|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
915012|NCT01044706|P2|Participant Flow|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
915013|NCT01044706|P1|Participant Flow|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
915014|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
915015|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
915016|NCT01044706|O2|Outcome|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
915017|NCT01044706|O1|Outcome|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
915018|NCT01044706|E2|Reported Event|Casodex® 50 mg Tablet|Casodex® 50 mg Tablet
915019|NCT01044706|E1|Reported Event|Bicalutamide 50 mg Tablet|Bicalutamide 50 mg Tablet
915020|NCT01044693|B1|Baseline|All Study Participants|Participants who were randomized to receive placebo, metoprolol, sildenafil and nebivolol in any order
915021|NCT01044693|P16|Participant Flow|Placebo Then Nebivolol Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915022|NCT01044693|P15|Participant Flow|Nebivolol Then Placebo Then Sildenafil Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915023|NCT01044693|P14|Participant Flow|Nebivolol Then Sildenafil Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915024|NCT01044693|P13|Participant Flow|Sildenafil Then Metoprolol Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915025|NCT01044693|P12|Participant Flow|Sildenafil Then Nebivolol Then Metoprolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915026|NCT01044693|P11|Participant Flow|Metoprolol Then Sildenafil Then Nebivolol Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915027|NCT01044693|P10|Participant Flow|Metoprolol Then Nebivolol Then Placebo Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915028|NCT01044693|P9|Participant Flow|Nebivolol Then Metoprolol Then Sildenafil Then Placebo|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915029|NCT01044693|P8|Participant Flow|Metoprolol Then Placebo Then Nebivolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915030|NCT01044693|P7|Participant Flow|Sildenafil Then Nebivolol Then Placebo Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915031|NCT01044693|P6|Participant Flow|Metoprolol Then Sildenafil Then Placebo Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915032|NCT01044693|P5|Participant Flow|Nebivolol Then Placebo Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915033|NCT01044693|P4|Participant Flow|Placebo Then Sildenafil Then Metoprolol Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915034|NCT01044693|P3|Participant Flow|Placebo Then Sildenafil Then Nebivolol Then Metoprolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915035|NCT01044693|P2|Participant Flow|Placebo Then Nebivolol Then Metoprolol Then Sildenafil|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915036|NCT01044693|P1|Participant Flow|Placebo Then Metoprolol Then Sildenafil Then Nebivolol|Single oral dose of: metoprolol tartrate 50 mg, sildenafil 25 mg, nebivolol 5 mg
915037|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
915038|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
915039|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
915040|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
915041|NCT01044693|O4|Outcome|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
915046|NCT01044693|O3|Outcome|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
920572|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
915051|NCT01044693|O2|Outcome|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
915052|NCT01044693|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
915053|NCT01044693|E4|Reported Event|Sildenafil 25 mg|"Sildenafil 25 mg single oral dose~Sildenafil25 mg: Sildenafil 25 mg single oral dose"
915054|NCT01044693|E3|Reported Event|Metoprolol Tartrate 50 mg|"Metoprolol tartrate 50 mg single oral dose~metoprolol tartrate 50 mg: metoprolol tartrate 50 mg single oral dose"
915055|NCT01044693|E2|Reported Event|Nebivolol 5 mg|"Nebivolol 5 mg capsule~Nebivolol 5 mg: Nebivolol 5mg single oral dose"
915056|NCT01044693|E1|Reported Event|Placebo Capsule|"Placebo capsule~Placebo: Placebo capsule"
915057|NCT01044537|B8|Baseline|Total|Total of all reporting groups
915058|NCT01044537|B7|Baseline|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915059|NCT01044537|B6|Baseline|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915060|NCT01044537|B5|Baseline|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915061|NCT01044537|B4|Baseline|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915062|NCT01044537|B3|Baseline|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915063|NCT01044537|B2|Baseline|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915064|NCT01044537|B1|Baseline|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915065|NCT01044537|P7|Participant Flow|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915066|NCT01044537|P6|Participant Flow|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915067|NCT01044537|P5|Participant Flow|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915068|NCT01044537|P4|Participant Flow|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915069|NCT01044537|P3|Participant Flow|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915070|NCT01044537|P2|Participant Flow|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915071|NCT01044537|P1|Participant Flow|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915072|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915073|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915074|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915075|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915076|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915077|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915078|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915079|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915080|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915081|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915082|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915083|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915084|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915085|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915086|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915087|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915088|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915089|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915090|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915091|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915092|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915093|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915094|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915095|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915096|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915097|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915098|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915099|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915100|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915101|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915102|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915103|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915104|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915105|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915106|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915107|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915108|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915109|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915110|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915111|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915112|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915113|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915114|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915115|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915116|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915117|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915118|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915119|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915120|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915121|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915122|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915123|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915124|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915125|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915126|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915127|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915128|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915129|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915130|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915131|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915132|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915133|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915134|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915135|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915136|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915137|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915138|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915139|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915140|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915141|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915142|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915143|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915144|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915145|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915146|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915147|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915148|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915149|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915150|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915151|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915152|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915153|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915154|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915155|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915156|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915157|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915158|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915159|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915160|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915161|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915162|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915163|NCT01044537|O7|Outcome|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915164|NCT01044537|O6|Outcome|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915165|NCT01044537|O5|Outcome|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915166|NCT01044537|O4|Outcome|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915167|NCT01044537|O3|Outcome|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915168|NCT01044537|O2|Outcome|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915169|NCT01044537|O1|Outcome|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915170|NCT01044537|E7|Reported Event|Placebo|Participants received single oral dose of placebo matched to PF-04937319 capsule on Day 1.
915171|NCT01044537|E6|Reported Event|PF-04937319 640 mg|Participants received single oral dose of PF-04937319 640 mg (8 capsules of 80 mg) on Day 1.
915172|NCT01044537|E5|Reported Event|PF-04937319 480 mg|Participants received single oral dose of PF-04937319 480 mg (6 capsules of 80 mg) on Day 1.
915173|NCT01044537|E4|Reported Event|PF-04937319 300 mg|Participants received single oral dose of PF-04937319 300 mg (3 capsules of 80 mg and 6 capsules of 10 mg) on Day 1.
915174|NCT01044537|E3|Reported Event|PF-04937319 100 mg|Participants received single oral dose of PF-04937319 100 mg (1 capsule of 80 mg and 2 capsules of 10 mg) on Day 1.
915175|NCT01044537|E2|Reported Event|PF-04937319 30 mg|Participants received single oral dose of PF-04937319 30 mg (3 capsules of 10 mg) on Day 1.
915176|NCT01044537|E1|Reported Event|PF-04937319 10 mg|Participants received single oral dose of PF-04937319 10 milligram (mg) capsule on Day 1.
915177|NCT01044498|B3|Baseline|Total|Total of all reporting groups
915178|NCT01044498|B2|Baseline|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915179|NCT01044498|B1|Baseline|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915180|NCT01044498|P2|Participant Flow|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915181|NCT01044498|P1|Participant Flow|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915182|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
944929|NCT00966238|E5|Reported Event|5.0 µg i.m.|
915183|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915184|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
920573|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
915185|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915186|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915187|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915188|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915189|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915190|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915191|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915192|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915193|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915194|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915195|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915196|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915197|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915198|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915199|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915200|NCT01044498|O2|Outcome|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915201|NCT01044498|O1|Outcome|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915202|NCT01044498|E2|Reported Event|Ortho-Novum® 1/35 (Group 2)|Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle.
915203|NCT01044498|E1|Reported Event|Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1)|Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously.
915204|NCT01044459|B3|Baseline|Total|Total of all reporting groups
915205|NCT01044459|B2|Baseline|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915206|NCT01044459|B1|Baseline|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915207|NCT01044459|P2|Participant Flow|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915208|NCT01044459|P1|Participant Flow|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915209|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915210|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915211|NCT01044459|O2|Outcome|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915212|NCT01044459|O1|Outcome|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915213|NCT01044459|E2|Reported Event|Aclidinium Bromide 400µg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915214|NCT01044459|E1|Reported Event|Aclidinium Bromide 200µg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
915252|NCT01044264|B2|Baseline|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915253|NCT01044264|B1|Baseline|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915215|NCT01044303|B1|Baseline|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
915258|NCT01044264|O2|Outcome|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915216|NCT01044303|P1|Participant Flow|Mycophenolic Acid Escalation|"Participants MPA dose was escalated to a minimum daily dose of 1440mg or equivalent, with the maximum dose never exceeding the manufacturer's recommendations.~Enteric-coated mycophenolate sodium: Dose increases of 180 mg every 3 months until DSA titer is zero or until maximum tolerable dose of mycophenolic acid is achieved. Maximum dose will not exceed 2160 mg daily."
915217|NCT01044303|O3|Outcome|Renal Function|Number of patients who had stable renal function throughout the study.
915218|NCT01044303|O2|Outcome|Rate of Rejection|Number of patients who had a rejection during the course of the study.
915219|NCT01044303|O1|Outcome|Rate of Infection|Number of patients who had an infection during the course of the study.
915220|NCT01044303|O1|Outcome|Mycophenolic Acid (MPA) Escalation|Patients receiving MPA (500mg to 2500mg of CellCept daily or 360mg to 1800mg myfortic daily), cyclosporine or tacrolimus with or without corticosteroids as part of their immunosuppressive regimen for at least 6 months
915221|NCT01044303|E1|Reported Event|Adverse Events|Adverse events reported by participants during the course of the study.
915222|NCT01044290|B4|Baseline|Total|Total of all reporting groups
915223|NCT01044290|B3|Baseline|Arm 3 Treatment as Usual|"Subjects in the third group (Treatment as Usual) were exposed to no intervention or attention control during the intervention window."
915224|NCT01044290|B2|Baseline|Arm 2 Attention Control|"The subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
915225|NCT01044290|B1|Baseline|Arm 1 -Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on issues of heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
915226|NCT01044290|P3|Participant Flow|Arm 3 Treatment as Usual|"Subjects in the third group (treatment as usual) were exposed to no intervention or attention control during the intervention window."
915227|NCT01044290|P2|Participant Flow|Attention Control|"Subjects in the second group (attention control) met with a facilitator three times for 45 minutes and listened to a non-guided relaxation CD.~Attention Control: Subjects will listen to a non-guided relaxation CD"
915228|NCT01044290|P1|Participant Flow|Outlook Intervention|"Subjects in the first group (Outlook Intervention) completed a psychosocial intervention which consisted of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects were asked to discuss issues related to life review. In session two, participants spoke about issues of regret and forgiveness. In the final session, subjects focused on heritage and legacy."
915229|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
915230|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received relaxation meditation as the attention control condition
915231|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
915232|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual.
915233|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control.
915234|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
915235|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants did not receive any intervention but rather care as usual.
915236|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition
915237|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
915238|NCT01044290|O3|Outcome|Arm 3 Usual Care|Participants did not receive any intervention but rather care as usual.
915239|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as the attention control condition.
915240|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
915241|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention but rather care as usual.
915242|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control condition.
915243|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook intervention
915244|NCT01044290|O3|Outcome|Arm 3 Treatment as Usual|Participants received no intervention, but rather care as usual
915245|NCT01044290|O2|Outcome|Arm 2 Attention Control|Participants received a relaxation meditation as attention control
915246|NCT01044290|O1|Outcome|Arm 1 -Outlook Intervention|Participants received the Outlook Intervention
915247|NCT01044290|E3|Reported Event|Treatment as Usual|"Subjects in the third group (treatment as usual) will be exposed to no intervention or attention control during the intervention window."
915248|NCT01044290|E2|Reported Event|Attention Control|"The subjects in the second group (attention control) will meet with a facilitator three times for 45 minutes and listen to a non-guided relaxation CD."
915249|NCT01044290|E1|Reported Event|Outlook Intervention|"Subjects in the first group (Life Completion) will complete a psychosocial intervention which consists of meeting with the facilitator three times for 45-60 minutes each. In the first session, subjects will be asked to discuss issues related to life review. In session two, participants will speak about issues of regret and forgiveness. In the final session, subjects will focus on heritage and legacy.~Life Completion: Subjects will discuss life review, issues of forgiveness and heritage and legacy."
915250|NCT01044264|B4|Baseline|Total|Total of all reporting groups
915251|NCT01044264|B3|Baseline|Placebo|Placebo : Placebo
915254|NCT01044264|P3|Participant Flow|Placebo|Placebo : Placebo
915255|NCT01044264|P2|Participant Flow|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915256|NCT01044264|P1|Participant Flow|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915257|NCT01044264|O3|Outcome|Placebo|Placebo : Placebo
915259|NCT01044264|O1|Outcome|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915260|NCT01044264|E3|Reported Event|Placebo|Placebo : Placebo
915261|NCT01044264|E2|Reported Event|DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Reference product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915262|NCT01044264|E1|Reported Event|1% Clindamycin/5% Benzoyl Peroxide Topical Gel|"Test product~1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel"
915263|NCT01044212|B3|Baseline|Total|Total of all reporting groups
915264|NCT01044212|B2|Baseline|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
915265|NCT01044212|B1|Baseline|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
915266|NCT01044212|P2|Participant Flow|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
915267|NCT01044212|P1|Participant Flow|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
915268|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
915269|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
915270|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
915271|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
915272|NCT01044212|O2|Outcome|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
915273|NCT01044212|O1|Outcome|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
915274|NCT01044212|E2|Reported Event|Docusate Controls|"Docusate is the standard of care regimen~Docusate sodium : Docusate 100mg BID"
915275|NCT01044212|E1|Reported Event|Bowel Medications|"Docusate, Miralax, Metamucil wafers, Bisacodyl suppository~Bowel medications : Docusate 100mg BID Metamucil fiber wafers - 2 wafers daily Miralax 1 packet daily Bisacodyl 1 suppository BID"
915276|NCT01044056|B4|Baseline|Total|Total of all reporting groups
915277|NCT01044056|B3|Baseline|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
915278|NCT01044056|B2|Baseline|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
915279|NCT01044056|B1|Baseline|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
915280|NCT01044056|P3|Participant Flow|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
915281|NCT01044056|P2|Participant Flow|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
915282|NCT01044056|P1|Participant Flow|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
915283|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
915284|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
915285|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
915286|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
915287|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
915364|NCT01043705|E1|Reported Event|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
915288|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
915289|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
915290|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
915291|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
915292|NCT01044056|O3|Outcome|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|NuvaRing®, one ring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonogestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonogestrel and 0.015 mg EE.
915293|NCT01044056|O2|Outcome|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM)), one patch for seven (7) days for three consecutive weeks, three (3) patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgestromin and 0.750 mg EE releasing 0.150 mg norelgestromin and 0.020 mg EE per day.
915294|NCT01044056|O1|Outcome|Levonorgestrel/Ethinylestradiol Oral Contraceptive Pill|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon® 30), 21 in total, containing 0.150 mg LNG and 0.030 mg EE per tablet administered once daily orally for 21 consecutive days.
915295|NCT01044056|E3|Reported Event|Etonogestrel and Ethinylestradiol Contraceptive Vaginal Ring|Nuvaring(R), one nring for a period of 21 days, inserted vaginally. Dose: per ring 11.7 mg etonrgestrel (ENG) and 2.7 mg EE releasing a daily average amount of 0.120 mg etonorgestrel and 0.015 mg EE
915296|NCT01044056|E2|Reported Event|Norelgestrominum and Ethinylestradiol Contraceptive Patch|A contraceptive patch (EVRA(TM), one patch for 7 days for three consecutive weeks, 3 patches in total, applied on the lower abdomen. Dose: per patch 6 mg norelgetromin and 0.750 mg EE releasing 0.150 mg norelegestromin and 0.020 mg EE per day.
915297|NCT01044056|E1|Reported Event|Levonorgestrel/Ethinylestradiol Oral Contraceptive Tablets|Levonorgestrel (LNG)/ethinylestradiol (EE) oral contraceptive tablets (Microgynon(R) 30), 21 in total, containing 0.150 mg LNG and 0.030 EE per tablet administered once daily orally for 21 consecutive days.
915298|NCT01044030|B3|Baseline|Total|Total of all reporting groups
915299|NCT01044030|B2|Baseline|Placebo|Placebo: 7.5 mL by mouth three times daily
915300|NCT01044030|B1|Baseline|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
915301|NCT01044030|P2|Participant Flow|Placebo|Placebo: 7.5 mL by mouth three times daily
915302|NCT01044030|P1|Participant Flow|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
915303|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
915304|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
915305|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
915306|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
915307|NCT01044030|O2|Outcome|Placebo|Placebo: 7.5 mL by mouth three times daily
915308|NCT01044030|O1|Outcome|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
915309|NCT01044030|E2|Reported Event|Placebo|Placebo: 7.5 mL by mouth three times daily
915310|NCT01044030|E1|Reported Event|Xylitol Syrup|Xylitol syrup: 7.5 mL (5 grams) by mouth three times daily
915311|NCT01043939|B1|Baseline|Entire Study Population|Includes groups randomized to receive purple grape juice first and apple juice first
915312|NCT01043939|P2|Participant Flow|Arm 2 Apple Juice Then Purple Grape Juice|Arm 2: 6 ounces of clear apple juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of purple grape juice twice daily during 4 weeks (intervention period 2).
915313|NCT01043939|P1|Participant Flow|Arm 1 Purple Grape Juice Then Apple Juice|Arm 1: 6 ounces of grape juice twice daily during first 4 weeks of intervention (intervention period 1) followed by a 4 week washout period followed by 6 ounces of clear apple juice twice daily during 4 weeks (intervention period 2).
915314|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
915315|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
915316|NCT01043939|O2|Outcome|Arm 2 Apple Juice Then Purple Grape Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
915317|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
915318|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
915319|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
915320|NCT01043939|O2|Outcome|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
915321|NCT01043939|O1|Outcome|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
915322|NCT01043939|E2|Reported Event|Apple Juice|6 ounces of clear apple juice consumed twice daily in either the first or second intervention period
915323|NCT01043939|E1|Reported Event|Purple Grape Juice|6 ounces of grape juice consumed twice daily in either the first or second intervention period
915324|NCT01043926|B3|Baseline|Total|Total of all reporting groups
915325|NCT01043926|B2|Baseline|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915326|NCT01043926|B1|Baseline|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915327|NCT01043926|P4|Participant Flow|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
915328|NCT01043926|P3|Participant Flow|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled on this arm.
915329|NCT01043926|P2|Participant Flow|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915330|NCT01043926|P1|Participant Flow|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915331|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915332|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915333|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915334|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915335|NCT01043926|O2|Outcome|Healthy Participants (Part II)|Healthy participants matched to participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
915336|NCT01043926|O1|Outcome|Participants With Mild Hepatic Insufficiency (Part II)|Participants with mild hepatic insufficiency were to receive a single dose of 20 mg open-label suvorexant during Part II of the study. No participants were enrolled in this arm.
915337|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915338|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915339|NCT01043926|O2|Outcome|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915340|NCT01043926|O1|Outcome|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915341|NCT01043926|E2|Reported Event|Healthy Participants (Part I)|Healthy participants matched to participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915342|NCT01043926|E1|Reported Event|Participants With Moderate Hepatic Insufficiency (Part I)|Participants with moderate hepatic insufficiency received a single dose of 20 mg open-label suvorexant.
915343|NCT01043874|B1|Baseline|Nilotinib|Nilotinib 400 mg BID
915344|NCT01043874|P1|Participant Flow|Nilotinib|Nilotinib 400 mg BID
915345|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
915346|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
915347|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
915348|NCT01043874|O1|Outcome|Nilotinib|Nilotinib 400 mg BID
915349|NCT01043874|E1|Reported Event|Nilotinib|Nilotinib 400 mg BID
915350|NCT01043705|B4|Baseline|Total|Total of all reporting groups
915351|NCT01043705|B3|Baseline|CIED Replacement With CRT and TYRX Vs. Case Match Arm|Prospective CRT patients who received a TYRX envelope and had a valid case match retrospective patient. This is a subset of all CRT/TYRX patients
915352|NCT01043705|B2|Baseline|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
915353|NCT01043705|B1|Baseline|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
915354|NCT01043705|P3|Participant Flow|CRT With no TYRX Retrospective Case Control|Retrospective site matched and case-matched CRT replacement patients who did not receive a TYRX envelope selected in the era just prior to availability of TYRX Envelope
915355|NCT01043705|P2|Participant Flow|CRT and TYRX Cases, Matched to Retrospective Non-TYRX Implants|Patients receiving a TYRX envelope who were eligible to participate having a replacement CRT implant who have a valid non-TYRX implant case-match
915356|NCT01043705|P1|Participant Flow|ICD With TYRX Implant|All patients receiving a TYRX envelope who were eligible to participate having a replacement ICD implant
915357|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
915358|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
915359|NCT01043705|O1|Outcome|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
915360|NCT01043705|O3|Outcome|CIED Replacement With CRT and TYRX vs. Case Match Arm|CIED replacement with CRT and TYRX vs. Case Match Arm; CRT patients who have corresponding non-TYRX implant case-match
915361|NCT01043705|O2|Outcome|CIED Replacement With CRT and no TYRX|(Retrospective Case-Control Arm) Patients who have undergone CIED replacement with a CRT and no TYRX Anti-bacterial envelope, with or without lead revision/addition.
915362|NCT01043705|O1|Outcome|CIED Replacement With CRT and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with a CRT and the TYRX Anti-bacterial envelope, with or without lead revision.
915363|NCT01043705|E2|Reported Event|CIED Replacement With ICD and TYRX|(Prospective Arm) Patients who have undergone CIED replacement with an ICD and the TYRX Anti-bacterial envelope, with or without lead revision.
915411|NCT01043432|B4|Baseline|No TBI and no History of Suicidal Behavior Group 4|No TBI and no history of suicidal behavior
915365|NCT01043653|B1|Baseline|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
915366|NCT01043653|P1|Participant Flow|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
915367|NCT01043653|O1|Outcome|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
915368|NCT01043653|O1|Outcome|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in VA mental health outpatient programs
915369|NCT01043653|E1|Reported Event|Maryland Assessment of Recovery in Serious Mental Illness|Individuals with serious mental illness treated in mental health outpatient programs
915370|NCT01043640|B1|Baseline|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915371|NCT01043640|P1|Participant Flow|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915372|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915373|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915374|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915375|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915376|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915412|NCT01043432|B3|Baseline|No TBI and a History of Suicidal Behavior Group 3|No TBI and a history of suicidal behavior
944930|NCT00966238|E4|Reported Event|3.0 µg i.m.|
915385|NCT01043523|B1|Baseline|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915417|NCT01043432|P2|Participant Flow|Group 2|Moderate/Severe TBI and no history of suicidal behavior = 51
915418|NCT01043432|P1|Participant Flow|Group 1|Moderate/severe TBI and history of suicidal behavior = 22
915377|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915378|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915379|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915380|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915381|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915382|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915383|NCT01043640|O1|Outcome|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915384|NCT01043640|E1|Reported Event|Transplant Patients|"Includes patients who received allogeneic stem cell transplantation following treatment plan of Campath-1H, cyclophosphamide, cyclosporine A, mycophenolate mofetil, and busulfan.~Campath-1H: Days -21, -20 and -19, 0.3 mg/kg SQ or IV Cyclophosphamide: Days -10 through -6, 50 mg/kg/day IV with Mesna Busulfan: Days -5 through Day -2, 1.1 mg/kg/dose IV if ≤ 12 kg; 0.8 mg/kg/dose IV if > 12 kg Allogeneic stem cell transplantation: > 24 hours after last dose of busulfan Cyclosporine A: 2.5 mg/kg/dose IV beginning on day –3. Dosing will be 3 times daily if body weight is ≤ 40 kg and 2 times daily if body weight is > 40 kg~Mycophenolate Mofetil: 15 mg/kg/dose (max dose of 1gram) IV three times a day beginning on Day -3 at a dose based on body weight:~Stop MMF at Day +42 or 7 days after engraftment achieved (ANC>500 x 10^6 neutrophils/L x 3 days and chimerism >90%), whichever is later."
915413|NCT01043432|B2|Baseline|Moderate/Severe TBI and no History of Suicidal behaviorGroup 2|Moderate/Severe TBI and no history of suicidal behavior
916079|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
915386|NCT01043523|P1|Participant Flow|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915387|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915388|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915389|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915390|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915391|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915392|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
915393|NCT01043523|O1|Outcome|Precontrast|51 eligible for accuracy, 24 eligible for sensitivity, 27 eligible for specificity
915394|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915395|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915396|NCT01043523|O2|Outcome|Combined Precontrast / Postcontrast|Based on the Combined precontrast / postcontrast image read, biopsy was recommended for 24 subjects and follow-up for 13 subjects
915397|NCT01043523|O1|Outcome|Precontrast|45 subjects had a change based on the Precontrast image read
915398|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915399|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915400|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915401|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915402|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915403|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915404|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915405|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915406|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915407|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915408|NCT01043523|O1|Outcome|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver Magnetic Resonance Imaging (MRI) as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records
915409|NCT01043523|E1|Reported Event|Gadoxetic Acid Disodium (Eovist, BAY86-4873)|Participants have received Primovist/Eovist for liver MRI as part of their routine care at participating institutions and additional diagnostic information are identified retrospectively from institution records.
915410|NCT01043432|B5|Baseline|Total|Total of all reporting groups
915414|NCT01043432|B1|Baseline|Moderate/Severe TBI and History of Suicidal Behavior Group 1|Moderate/severe TBI and history of suicidal behavior
915415|NCT01043432|P4|Participant Flow|Group 4|No TBI and no history of suicidal behavior = 48
915416|NCT01043432|P3|Participant Flow|Group 3|No TBI and a history of suicidal behavior = 12
915419|NCT01043432|O4|Outcome|Group 4|No TBI and no history of suicidal behavior
915420|NCT01043432|O3|Outcome|Group 3|No TBI and a history of suicidal behavior
915421|NCT01043432|O2|Outcome|Group 2|Moderate/Severe TBI and no history of suicidal behavior
915422|NCT01043432|O1|Outcome|Group 1|Moderate/severe TBI and history of suicidal behavior
915423|NCT01043432|E1|Reported Event|All Groups|
915424|NCT01043393|B3|Baseline|Total|Total of all reporting groups
915425|NCT01043393|B2|Baseline|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915426|NCT01043393|B1|Baseline|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area.~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915427|NCT01043393|P2|Participant Flow|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915428|NCT01043393|P1|Participant Flow|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915429|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915430|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915431|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915432|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915433|NCT01043393|O2|Outcome|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915434|NCT01043393|O1|Outcome|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915435|NCT01043393|E2|Reported Event|Psoriasis Involving >15% of BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of >15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915436|NCT01043393|E1|Reported Event|Psoriasis Involving 10-15% BSA|"Patients 18 years of age or older with a confirmed diagnosis of moderate to severe plaque psoriasis having involvement of 10-15% of their body surface area (BSA).~Desoximetasone 0.25% spray: Desoximetasone spray applied to affected areas twice daily for 28 days"
915437|NCT01043185|B1|Baseline|Entire Study Population|Includes all groups randomized to one of 10 sequences of drug or placebo.
915438|NCT01043185|P10|Participant Flow|First Placebo, Then 120mg, Then 30mg, Then 240mg|Period 1: placebo. Period 2: AZD3355 120mg. Period 3: AZD3355 30mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
915439|NCT01043185|P9|Participant Flow|First 240mg, Then 30mg, Then 90mg, Then Placebo|Period 1: AZD3355 240mg. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: placebo. Morning and evening dose in each period.
915440|NCT01043185|P8|Participant Flow|First 120mg, Then 30mg, Then 240mg, Then Placebo|Period 1: AZD3355 120mg. Period 2: AZD3355 30mg. Period 3: AZD3355 240mg. Period 4: placebo. Morning and evening dose in each period.
915441|NCT01043185|P7|Participant Flow|First 90mg, Then 120mg, Then Placebo, Then 240mg|Period 1: AZD3355 90mg. Period 2: AZD3355 120mg. Period 3: placebo. Period 4: AZD3355 240mg. Morning and evening dose in each period.
915442|NCT01043185|P6|Participant Flow|First Placebo, Then 240mg, Then 90mg, Then 30mg|Period 1: placebo. Period 2: AZD3355 240mg. Period 3: AZD3355 90mg. Period 4: AZD3355 30mg. Morning and evening dose in each period.
915443|NCT01043185|P5|Participant Flow|First 90mg, Then Placebo, Then 120mg, Then 240mg|Period 1: AZD3355 90mg. Period 2: placebo. Period 3: AZD3355 120mg. Period 4: AZD3355 240mg. Morning and evening dose in each period.
915444|NCT01043185|P4|Participant Flow|First Placebo, Then 30mg, Then 90mg, Then 120mg|Period 1: placebo. Period 2: AZD3355 30mg. Period 3: AZD3355 90mg. Period 4: AZD3355 120mg. Morning and evening dose in each period.
915445|NCT01043185|P3|Participant Flow|First 120mg, Then Placebo, Then 240mg, Then 90mg|Period 1: AZD3355 120mg. Period 2: placebo. Period 3: AZD3355 240mg. Period 4: AZD3355 90mg. Morning and evening dose in each period.
915446|NCT01043185|P2|Participant Flow|First 30mg, Then 90mg, Then Placebo, Then 120mg|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: placebo. Period 4: AZD3355 120mg. Morning and evening dose in each period.
944931|NCT00966238|E3|Reported Event|2.0 µg i.m.|
915447|NCT01043185|P1|Participant Flow|First 30mg, Then 90mg, Then 120mg, Then Placebo|Period 1: AZD3355 30mg. Period 2: AZD3355 90mg. Period 3: AZD3355 120mg. Period 4: placebo. Morning and evening dose in each period.
915448|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
915449|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
915450|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
920574|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
915451|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
915452|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
915453|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
915454|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
915455|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
915456|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
915457|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
915458|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
915459|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
915460|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
915461|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
915462|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
915463|NCT01043185|O5|Outcome|Placebo|a morning and an evening dose of placebo
915464|NCT01043185|O4|Outcome|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
915465|NCT01043185|O3|Outcome|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
915466|NCT01043185|O2|Outcome|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
915467|NCT01043185|O1|Outcome|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
915468|NCT01043185|E5|Reported Event|Placebo|a morning and an evening dose of placebo
915469|NCT01043185|E4|Reported Event|AZD3355 240 mg|a morning and an evening dose of AZD3355 240 mg
915470|NCT01043185|E3|Reported Event|AZD3355 120 mg|a morning and an evening dose of AZD3355 120 mg
915471|NCT01043185|E2|Reported Event|AZD3355 90 mg|a morning and an evening dose of AZD3355 90 mg
915472|NCT01043185|E1|Reported Event|AZD3355 30 mg|a morning and an evening dose of AZD3355 30 mg
915473|NCT01043146|B7|Baseline|Total|Total of all reporting groups
915474|NCT01043146|B6|Baseline|240 mg COR-1|single intravenous administration
915475|NCT01043146|B5|Baseline|160 mg COR-1|single intravenous administration
915476|NCT01043146|B4|Baseline|80 mg COR-1|single intravenous administration
915477|NCT01043146|B3|Baseline|40 mg COR-1|single intravenous administration
915478|NCT01043146|B2|Baseline|10 mg COR-1|single intravenous administration
915479|NCT01043146|B1|Baseline|Placebo|intravenous 0.9 % NaCl
915480|NCT01043146|P6|Participant Flow|240 mg COR-1|single intravenous administration
915481|NCT01043146|P5|Participant Flow|160 mg COR-1|single intravenous administration
915482|NCT01043146|P4|Participant Flow|80 mg COR-1|single intravenous administration
915483|NCT01043146|P3|Participant Flow|40 mg COR-1|single intravenous administration
915484|NCT01043146|P2|Participant Flow|10 mg COR-1|single intravenous administration
915485|NCT01043146|P1|Participant Flow|Placebo|intravenous 0.9 % NaCl
915486|NCT01043146|O6|Outcome|240 mg COR-1|single intravenous administration
915487|NCT01043146|O5|Outcome|160 mg COR-1|single intravenous administration
915488|NCT01043146|O4|Outcome|80 mg COR-1|single intravenous administration
915489|NCT01043146|O3|Outcome|40 mg COR-1|single intravenous administration
915490|NCT01043146|O2|Outcome|10 mg COR-1|single intravenous administration
915491|NCT01043146|O1|Outcome|Placebo|intravenous 0.9 % NaCl
915492|NCT01043146|E6|Reported Event|240 mg COR-1|single intravenous administration
915493|NCT01043146|E5|Reported Event|160 mg COR-1|single intravenous administration
915494|NCT01043146|E4|Reported Event|80 mg COR-1|single intravenous administration
915495|NCT01043146|E3|Reported Event|40 mg COR-1|single intravenous administration
915496|NCT01043146|E2|Reported Event|10 mg COR-1|single intravenous administration
915497|NCT01043146|E1|Reported Event|Placebo|intravenous 0.9 % NaCl
915498|NCT01043133|B3|Baseline|Total|Total of all reporting groups
915499|NCT01043133|B2|Baseline|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
915500|NCT01043133|B1|Baseline|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
915501|NCT01043133|P2|Participant Flow|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
915502|NCT01043133|P1|Participant Flow|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
915503|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
915504|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
915505|NCT01043133|O2|Outcome|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
915506|NCT01043133|O1|Outcome|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
915507|NCT01043133|E2|Reported Event|Control Group|Students exposed to clinical documentation workshop void of any of the 7 social marketing-based persuasion messages included in the intervention.
915508|NCT01043133|E1|Reported Event|Intervention Group|Students exposed to educational workshop on clinical documentation that was embedded with 7 select social marketing-based persuasion messages; reenforced behavior-seeking and behavior-avoidance based on template use.
915509|NCT01043094|B3|Baseline|Total|Total of all reporting groups
915510|NCT01043094|B2|Baseline|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
915511|NCT01043094|B1|Baseline|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
915512|NCT01043094|P2|Participant Flow|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
915513|NCT01043094|P1|Participant Flow|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
915514|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
915515|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
915516|NCT01043094|O2|Outcome|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
915517|NCT01043094|O1|Outcome|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
915518|NCT01043094|E2|Reported Event|Pitavastatin 4mg Healthy Subjects|Healthy subjects (GFR greater than or equal to 90 mL/min/1.73 m2)
915519|NCT01043094|E1|Reported Event|Pitavastatin 4mg Renal Impaired|Subjects with severe renal impairment (glomerular filtration rate [GFR] of 15 to 29 mL/min/1.73 m2, inclusive) who are not being treated with hemodialysis
915520|NCT01042977|B3|Baseline|Total|Total of all reporting groups
915521|NCT01042977|B2|Baseline|Placebo|Placebo plus usual care
915522|NCT01042977|B1|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915523|NCT01042977|P2|Participant Flow|Placebo|Placebo plus usual care
915524|NCT01042977|P1|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915525|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
915526|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915527|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
915528|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915529|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
915530|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915531|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
915532|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915533|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
915534|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915535|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
915536|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915537|NCT01042977|O2|Outcome|Placebo|Placebo plus usual care
915538|NCT01042977|O1|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915539|NCT01042977|E2|Reported Event|Placebo|Placebo plus usual care
915540|NCT01042977|E1|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus usual care
915541|NCT01042938|B3|Baseline|Total|Total of all reporting groups
915542|NCT01042938|B2|Baseline|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915543|NCT01042938|B1|Baseline|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915544|NCT01042938|P2|Participant Flow|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915545|NCT01042938|P1|Participant Flow|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915546|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915547|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915548|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915549|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915550|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915551|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915552|NCT01042938|O2|Outcome|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT)(~4-7 weeks).
915553|NCT01042938|O1|Outcome|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (RT) (~4-7 weeks).
915554|NCT01042938|E2|Reported Event|Placebo|Patients take 2.0 grams placebo (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915555|NCT01042938|E1|Reported Event|Curcumin C3 Complex|Patients take 2.0 grams curcumin (four 500mg capsules) three times daily by mouth for prescribed course of radiation treatment (~4-7 weeks).
915556|NCT01042678|B4|Baseline|Total|Total of all reporting groups
915558|NCT01042678|B2|Baseline|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915559|NCT01042678|B1|Baseline|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915560|NCT01042678|P6|Participant Flow|MP0112 (3.6 mg)|Single 3.6 mg intravitreal injection of MP0112 in the study eye.
915561|NCT01042678|P5|Participant Flow|MP0112 (2.0 mg)|Single 2.0 mg intravitreal injection of MP0112 in the study eye.
915562|NCT01042678|P4|Participant Flow|MP0112 (1.0 mg)|Single 1.0 mg intravitreal injection of MP0112 in the study eye.
915563|NCT01042678|P3|Participant Flow|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915564|NCT01042678|P2|Participant Flow|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915565|NCT01042678|P1|Participant Flow|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915566|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915567|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915568|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915569|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915570|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915571|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915572|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915573|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915574|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915575|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915576|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915577|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915578|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915579|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915580|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915581|NCT01042678|O3|Outcome|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915582|NCT01042678|O2|Outcome|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915583|NCT01042678|O1|Outcome|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915584|NCT01042678|E3|Reported Event|MP0112 (0.4 mg)|Single 0.4 mg intravitreal injection of MP0112 in the study eye.
915585|NCT01042678|E2|Reported Event|MP0112 (0.15 mg)|Single 0.15 mg intravitreal injection of MP0112 in the study eye.
915586|NCT01042678|E1|Reported Event|MP0112 (0.04 mg)|Single 0.04 mg intravitreal injection of MP0112 in the study eye.
915587|NCT01042613|B3|Baseline|Total|Total of all reporting groups
915588|NCT01042613|B2|Baseline|Standard|(standard technique of insertion of the intravenous cannula)
915589|NCT01042613|B1|Baseline|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
915590|NCT01042613|P2|Participant Flow|Standard|(standard technique of insertion of the intravenous cannula)
915591|NCT01042613|P1|Participant Flow|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
915592|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
915593|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
915594|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
915595|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
915596|NCT01042613|O2|Outcome|Standard|(standard technique of insertion of the intravenous cannula)
915597|NCT01042613|O1|Outcome|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
915598|NCT01042613|E2|Reported Event|Standard|(standard technique of insertion of the intravenous cannula)
915599|NCT01042613|E1|Reported Event|ACVein|Research participants are randomly assigned into group A (Accuvein AV300 assisted intravenous catheter insertion)
915600|NCT01042600|B3|Baseline|Total|Total of all reporting groups
915601|NCT01042600|B2|Baseline|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
915602|NCT01042600|B1|Baseline|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
915603|NCT01042600|P2|Participant Flow|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
915604|NCT01042600|P1|Participant Flow|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
915605|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
915606|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
944932|NCT00966238|E2|Reported Event|1.0 µg i.m.|
915607|NCT01042600|O2|Outcome|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
915608|NCT01042600|O1|Outcome|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
916085|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
915609|NCT01042600|E2|Reported Event|Laryngeal Mask Airway|"Laryngeal mask airway insertion for surfactant administration, following atropine pre-medication~Laryngeal mask airway insertion: Laryngeal mask airway insertion after premedication with atropine (0.02 mg/kg)"
915610|NCT01042600|E1|Reported Event|Endotracheal Intubation|"Endotracheal intubation for surfactant administration, following morphine and atropine pre-medication~Endotracheal tube insertion: Endotracheal tube insertion after premedication with atropine (0.02 mg/kg) and morphine (0.1 mg/kg)"
915611|NCT01042535|B1|Baseline|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915612|NCT01042535|P1|Participant Flow|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915613|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915614|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915615|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915616|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915617|NCT01042535|O1|Outcome|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915618|NCT01042535|E1|Reported Event|Treatment (Vaccine Therapy, 1-methyl-d-tryptophan)|"Participants receive adenovirus-p53 transduced dendritic cell (Ad.p53-DC) vaccine ID in weeks 1, 3, 5, and 10, and then every 3 weeks for 6 total doses. Participants also receive 1-methyl-d-tryptophan (indoximod) orally (PO) daily (QD) on days 1-21. Treatment with 1-methyl-d-tryptophan repeats every 28 days (patients with stable disease) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~adenovirus-p53 transduced dendritic cell (DC) vaccine: Given intradermally (ID)~1-methyl-d-tryptophan: Given orally (PO)~Laboratory biomarker analysis: Correlative studies"
915619|NCT01042509|B1|Baseline|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
915620|NCT01042509|P1|Participant Flow|Patients With Chronic GVHD|Patients with chronic GVHD after first-line therapy failure.
915621|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
915622|NCT01042509|O1|Outcome|Treatment Group|This study had only one arm
915623|NCT01042509|E1|Reported Event|Treatment Group|This study had only one arm
915624|NCT01042496|B3|Baseline|Total|Total of all reporting groups
915625|NCT01042496|B2|Baseline|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
916080|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
915669|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915626|NCT01042496|B1|Baseline|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915627|NCT01042496|P2|Participant Flow|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915628|NCT01042496|P1|Participant Flow|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915629|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
915630|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915631|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
915632|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915633|NCT01042496|O4|Outcome|Bipolar Lamotrigine Group as Whole|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (DLPFC)."
915634|NCT01042496|O3|Outcome|Bipolar Lamotrigine Non-Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~Non-responders were those bipolar participants who did not achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12 at week 12)."
915635|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915636|NCT01042496|O1|Outcome|Bipolar Lamotrigine Responders Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915637|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915638|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915639|NCT01042496|O2|Outcome|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915691|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915692|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915640|NCT01042496|O1|Outcome|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks. Flexible titration for early response and/or side effects.~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915641|NCT01042496|E2|Reported Event|Control Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC).~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915642|NCT01042496|E1|Reported Event|Bipolar Group|"Subjects underwent proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC) before and after treatment with Lamotrigine.~Lamotrigine: 12 week open trial: 25mg/day for 2 weeks, 50mg/day for 2 weeks, 100mg/day for 2 weeks, 200mg/day for 6 weeks~1H-MR: Proton magnetic resonance spectroscopy (1H-MR) evaluation of medial anterior cingulate cortex (MACC) and left dorsal lateral prefrontal cortex (LDLPC)."
915643|NCT01042392|B3|Baseline|Total|Total of all reporting groups
915644|NCT01042392|B2|Baseline|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915645|NCT01042392|B1|Baseline|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915646|NCT01042392|P4|Participant Flow|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
915647|NCT01042392|P3|Participant Flow|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915648|NCT01042392|P2|Participant Flow|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
915649|NCT01042392|P1|Participant Flow|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915650|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915651|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915652|NCT01042392|O4|Outcome|Placebo to Aliskiren|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
915653|NCT01042392|O3|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915654|NCT01042392|O2|Outcome|Placebo to Ramipril|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
915655|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915693|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915694|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915656|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915657|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915658|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915659|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915660|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915661|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915662|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915663|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915664|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915665|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915666|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915667|NCT01042392|O1|Outcome|Ramipril|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915668|NCT01042392|O2|Outcome|Aliskiren|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received placebo or the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915805|NCT01041573|B2|Baseline|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
915670|NCT01042392|E4|Reported Event|Placebo to Aliskiren (Period III)|In period III (double-blind withdrawal): At visit 4, part of patients from Aliskiren arm received placebo for 1 day. The study ended at visit 5 (48 hours later than visit 4).
915671|NCT01042392|E3|Reported Event|Aliskiren (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Aliskiren 150 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to aliskiren 300 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, part of patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915672|NCT01042392|E2|Reported Event|Placebo to Ramipril (Period III)|In period III (double-blind withdrawal): At visit 4, part of the patients from Ramipril arm received placebo to Ramipril for 1 day. The study ended at visit 5 (48 hours later than visit 4).
915673|NCT01042392|E1|Reported Event|Ramipril (Period II and III)|"In period I (washout and single-blind): from visit 1 to visit 2, 2 weeks placebo run-in.~In period II (double-blind treatment, randomized): Ramipril 5 mg for 4 weeks (visit 2 - visit 3). At visit 3, medications had to be titrated to Ramipril 10 mg only if BP remained ≥ 140/90 mmHg. Double blind treatment had to be continued for another 4-week period until visit 4.~In period III (double-blind withdrawal): At visit 4, patients received the active treatment for 1 day. The study ended at visit 5 (48 hours later than visit 4)."
915674|NCT01042288|B1|Baseline|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915675|NCT01042288|P1|Participant Flow|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915676|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915677|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915678|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915679|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915680|NCT01042288|O1|Outcome|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915681|NCT01042288|E1|Reported Event|Carboplatin/Pemetrexed/Panitumumab|"Systemic Therapy~Carboplatin: Carboplatin AUC=6IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Pemetrexed: Pemetrexed 500mg/m² IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)~Panitumumab: Panitumumab 9mg/kg IV, Day 1 of Cycles 1-6 (Cycles are 3 weeks / 21 days in length)"
915682|NCT01042236|B1|Baseline|Entire Study Population|Includes groups randomized to receive Fesoterodine (4mg) first, Fesoterodine (8mg) first, and Placebo first.
915683|NCT01042236|P6|Participant Flow|Sequence CBA|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
915684|NCT01042236|P5|Participant Flow|Sequence BAC|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then placebo matching study treatment (C) with 7 day washout between dosing periods.
915685|NCT01042236|P4|Participant Flow|Sequence ACB|Fesoterodine 4 mg (A) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
915686|NCT01042236|P3|Participant Flow|Sequence CAB|Placebo matching study treatment (C) tablet administered PO OD for 7 days with a 7 day washout period followed by Fesoterodine 4 mg (A) then Fesoterodine 8 mg (B) with 7 day washout between dosing periods.
915687|NCT01042236|P2|Participant Flow|Sequence BCA|Fesoterodine 8 mg (B) tablet administered PO OD for 7 days with a 7 day washout period followed by placebo matching study treatment (C) then Fesoterodine 4 mg (A) with 7 day washout between dosing periods.
915688|NCT01042236|P1|Participant Flow|Sequence ABC|Fesoterodine 4 mg (A) tablet administered by mouth (PO) once daily (OD) for 7 days with a 7 day washout period followed by Fesoterodine 8 mg (B) then placebo matching study treatment (C) with 7 day washout between dosing periods.
915689|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915690|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915695|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915696|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915697|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915698|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915699|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915700|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915701|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915702|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915703|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915704|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915705|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915706|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915707|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915708|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915709|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915710|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915711|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915712|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915713|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915714|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915715|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915716|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915717|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915718|NCT01042236|O3|Outcome|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915719|NCT01042236|O2|Outcome|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915720|NCT01042236|O1|Outcome|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915721|NCT01042236|E3|Reported Event|Placebo|Placebo matching study treatment for 7 days with a 7 day washout period in either first, second or third treatment period.
915722|NCT01042236|E2|Reported Event|Fesoterodine (8 mg)|Fesoterodine 8 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915723|NCT01042236|E1|Reported Event|Fesoterodine (4 mg)|Fesoterodine 4 mg tablet administered PO OD for 7 days with a 7 day washout period in either first, second or third treatment period.
915724|NCT01042145|B3|Baseline|Total|Total of all reporting groups
915725|NCT01042145|B2|Baseline|Dexamethasone|
915726|NCT01042145|B1|Baseline|Prednisone|
915727|NCT01042145|P2|Participant Flow|Dexamethasone|
915728|NCT01042145|P1|Participant Flow|Prednisone|
915729|NCT01042145|O2|Outcome|Dexamethasone|
915730|NCT01042145|O1|Outcome|Prednisone|
915731|NCT01042145|O2|Outcome|Dexamethasone|
915732|NCT01042145|O1|Outcome|Prednisone|
915733|NCT01042145|O2|Outcome|Dexamethasone|
915734|NCT01042145|O1|Outcome|Prednisone|
915735|NCT01042145|O2|Outcome|Dexamethasone|
915736|NCT01042145|O1|Outcome|Prednisone|
915737|NCT01042145|O2|Outcome|Dexamethasone|
915738|NCT01042145|O1|Outcome|Prednisone|
915739|NCT01042145|O2|Outcome|Dexamethasone|
915740|NCT01042145|O1|Outcome|Prednisone|
915741|NCT01042145|E2|Reported Event|Dexamethasone|
915742|NCT01042145|E1|Reported Event|Prednisone|
915743|NCT01042093|B5|Baseline|Total|Total of all reporting groups
915744|NCT01042093|B4|Baseline|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
915745|NCT01042093|B3|Baseline|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915746|NCT01042093|B2|Baseline|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
915747|NCT01042093|B1|Baseline|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915748|NCT01042093|P4|Participant Flow|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
915749|NCT01042093|P3|Participant Flow|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915750|NCT01042093|P2|Participant Flow|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
915751|NCT01042093|P1|Participant Flow|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915752|NCT01042093|O4|Outcome|REP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
915753|NCT01042093|O3|Outcome|REP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915754|NCT01042093|O2|Outcome|REP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
915755|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915756|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
915757|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915758|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
915759|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915760|NCT01042093|O4|Outcome|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
915761|NCT01042093|O3|Outcome|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915762|NCT01042093|O2|Outcome|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
915763|NCT01042093|O1|Outcome|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915764|NCT01042093|E4|Reported Event|ROP/EPI|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml)
915765|NCT01042093|E3|Reported Event|ROP/EPI/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915766|NCT01042093|E2|Reported Event|ROP/EPI/TOR|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml)
915767|NCT01042093|E1|Reported Event|ROP/EPI/TOR/CLO|Ropivicaine 5mg/ml (49.25 ml) Epinephrine 1 mg/ml (0.5 ml) Toradol 30mg/ml (1 ml) Clonidine 0.1 mg/ml (0.08mg - 0.8 ml)
915768|NCT01041976|B3|Baseline|Total|Total of all reporting groups
915769|NCT01041976|B2|Baseline|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
915770|NCT01041976|B1|Baseline|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
915771|NCT01041976|P2|Participant Flow|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
915772|NCT01041976|P1|Participant Flow|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
915773|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
915774|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
915775|NCT01041976|O2|Outcome|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
915776|NCT01041976|O1|Outcome|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
915806|NCT01041573|B1|Baseline|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
915807|NCT01041573|P4|Participant Flow|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
915808|NCT01041573|P3|Participant Flow|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
915777|NCT01041976|E2|Reported Event|Support and Education for Recovery (SER)|Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
916086|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
920575|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
915778|NCT01041976|E1|Reported Event|Adapted Motivational Interviewing (AMI)|Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
915779|NCT01041859|B3|Baseline|Total|Total of all reporting groups
915780|NCT01041859|B2|Baseline|DB Placebo|Double-Blind Placebo Control Group
915781|NCT01041859|B1|Baseline|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915782|NCT01041859|P3|Participant Flow|DB Placebo|Double-Blind Placebo Control Group
915783|NCT01041859|P2|Participant Flow|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915784|NCT01041859|P1|Participant Flow|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
915785|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
915786|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915787|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
915788|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915789|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
915790|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915791|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
915792|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915793|NCT01041859|O2|Outcome|DB Placebo|Double-Blind Placebo Control Group
915794|NCT01041859|O1|Outcome|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915795|NCT01041859|E3|Reported Event|DB Placebo|Double-Blind Placebo Control Group
915796|NCT01041859|E2|Reported Event|DB Tapentadol ER|Tapentadol extended release (ER) 100 150 200 250 mg twice daily for 12 weeks
915797|NCT01041859|E1|Reported Event|OL Tapentadol|Tapentadol extended release (ER) 50 100 150 200 250 mg twice daily for 3 weeks
915798|NCT01041638|B1|Baseline|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
915799|NCT01041638|P1|Participant Flow|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
915800|NCT01041638|O1|Outcome|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
915801|NCT01041638|E1|Reported Event|Chimeric Antibody 14.18 With GM-CSF, IL-2 and Isotretinoin|Patients receive sargramostim subcutaneously or IV over 2 hours on days 0-13 of courses 1, 3, and 5 (dose: 250 micrograms/m²/dose); monoclonal antibody Ch14.18 IV over 10 hours on days 3-6 of courses 1, 3, and 5 and on days 7-10 of courses 2 and 4 (dose: 25 mg/m2/dose); and oral isotretinoin twice daily on days 11-24 of course 1, on days 14-27 of courses 2, 4, and 6, and on days 10-23 of courses 3 and 5 (Weight based dosage: > 12 kg: 80 mg/m2/dose BID; total daily dose 160 mg/m2/day, divided BID. ≤ 12 kg: 2.67 mg/kg/dose BID; total daily dose is 5.33 mg/kg/day, divided BID. Round dose up to the nearest 10 mg). Patients also receive aldesleukin IV continuously on days 0-3 and on days 7-10 of courses 2 and 4 (actual dosage is body surface area based and varies by course). Treatment repeats every 24-32 days for 6 courses in the absence of disease progression or unacceptable toxicity.
915802|NCT01041573|B5|Baseline|Total|Total of all reporting groups
915803|NCT01041573|B4|Baseline|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day56 and month 7-13
915804|NCT01041573|B3|Baseline|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
944933|NCT00966238|E1|Reported Event|0.5 µg i.m.|
915809|NCT01041573|P2|Participant Flow|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
915810|NCT01041573|P1|Participant Flow|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
915919|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
915811|NCT01041573|O4|Outcome|Prevnar|"Subjects aged ≥ 2 to < 6 months: 4 intramuscular vaccinations, Days 0, 28, 56 and Month 7‐13 (subjects aged ≥ 2 to < 6 months were to receive the fourth Prevnar® vaccination when 12‐15 months old, i.e., the vaccination was to be performed outside the study, depending on the subject´s age at day of first vaccination).~Subjects aged ≥ 6 months to < 1 year: 3 intramuscular vaccinations, Days 0, 56 and Month 7."
915812|NCT01041573|O3|Outcome|Havrix 720|Havrix®720 0.5 ml im. at day 0 and month 7
915813|NCT01041573|O2|Outcome|IC51, Subjects Aged >= 2 Months to <1 Year|Japanese Encephalitis Vaccine 3mcg im. at day 0 and day 28
915814|NCT01041573|O1|Outcome|IC51, Subjects Aged >= 1 Year|IC51 Japanese Encephalitis: 6 mcg or 3 mcg im. at day 0 and day 28
915815|NCT01041573|E4|Reported Event|Prevnar|Prevnar 0.5 ml i.m. at day 0 and day 56 and month 7 or 0.5 ml i.m. at day 0, day 28 and day 56 and month 7-13
915816|NCT01041573|E3|Reported Event|Havrix 720|Havrix®720 0.5 ml i.m. at day 0 and month 7
915817|NCT01041573|E2|Reported Event|IC51 0.25 mL|Japanese Encephalitis Vaccine 3mcg i.m. at day 0 and day 28
915818|NCT01041573|E1|Reported Event|IC51 0.5 mL|Japanese Encephalitis Vaccine 6mcg i.m. at day 0 and day 28
915819|NCT01041417|B3|Baseline|Total|Total of all reporting groups
915820|NCT01041417|B2|Baseline|Placebo|Saline injection - three times for four weeks
915821|NCT01041417|B1|Baseline|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915822|NCT01041417|P2|Participant Flow|Placebo|Saline injection - three times for four weeks
915823|NCT01041417|P1|Participant Flow|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915824|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915825|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915826|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915827|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915828|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915829|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915830|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915831|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915832|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915833|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915834|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915835|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915836|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
915837|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
915838|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
915839|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
915840|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
915841|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
915842|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
915843|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
915844|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915845|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915846|NCT01041417|O2|Outcome|Placebo|Placebo: 79 subjects were randomized to receive placebo on Monday, Wednesday and Friday for 4 weeks.
915847|NCT01041417|O1|Outcome|GM-CSF|Granulocyte-Macrophage Colony Stimulating Factor: 80 subjects were randomized to receive GM-CSF Monday, Wednesday and Friday for 4 weeks of therapy.
915848|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915849|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915850|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915851|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915852|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915853|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915854|NCT01041417|O2|Outcome|Placebo|Saline injection - three times for four weeks
915855|NCT01041417|O1|Outcome|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - three times for four weeks~500 microgram dose of GM-CSF"
915856|NCT01041417|E2|Reported Event|Placebo|Saline injection - Monday, Wednesday and Friday for 4 weeks.
915857|NCT01041417|E1|Reported Event|GM-CSF|"Granulocyte-Macrophage Colony Stimulating Factor injection - Monday, Wednesday and Friday for 4 weeks of therapy.~500 microgram dose of GM-CSF"
915858|NCT01041404|B3|Baseline|Total|Total of all reporting groups
915920|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital) guidelines
916087|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
915859|NCT01041404|B2|Baseline|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915860|NCT01041404|B1|Baseline|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915861|NCT01041404|P2|Participant Flow|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 milligrams per kilogram (mg/kg), IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915862|NCT01041404|P1|Participant Flow|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-fluorouracil [5-FU] or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, orally (PO), twice daily (BID) from the evening of Day 1 through the morning of Day 15.
915863|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915864|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915865|NCT01041404|O1|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915866|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915867|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915868|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915869|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915870|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915871|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915918|NCT01041209|O2|Outcome|Guideline|Indication of antibiotics according to local (Hospital)guidelines.
944934|NCT00966186|B3|Baseline|Total|Total of all reporting groups
915872|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915873|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915874|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915875|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915876|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915877|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915878|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915879|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915880|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915881|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915882|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915883|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915884|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915885|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915886|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915887|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915888|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915889|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915890|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915891|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915892|NCT01041404|O2|Outcome|Trastuzumab, Fluoropyrimidine, Cisplatin|Participants received an initial loading dose of trastuzumab 8 mg/kg, IV, on Day 1 of cycle, followed by 6 mg/kg, IV, every 3 weeks until disease progression. Participants also received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles; cisplatin 80 mg/m^2 IV on Day 1 of cycle every 3 weeks for 6 cycles; and capecitabine 1000 mg/m^2 PO twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
915893|NCT01041404|O1|Outcome|Fluoropyrimidine, Cisplatin|Participants received fluorouracil 800 mg/m^2 IV on Days 1 through 5 of cycle every 3 weeks for 6 cycles. Participants also received cisplatin 80 mg/m^2, IV, on Day 1 of cycle every 3 weeks for 6 cycles; as well as, capecitabine 1000 mg/m^2, PO, twice daily on Days 1 through 15 of cycle every 3 weeks for 6 cycles.
915894|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915895|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915896|NCT01041404|O2|Outcome|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915897|NCT01041404|O1|Outcome|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915898|NCT01041404|E2|Reported Event|Trastuzumab + Fluoropyrimidine/Cisplatin (FP + H)|Participants received trastuzumab plus fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles (except as noted) as follows: trastuzumab 8 mg/kg, IV, on Day 1 (Cycle 1), followed by 6 mg/kg, IV (Cycles 2 onward, administered until disease progression); cisplatin 80 mg/m^2 IV on Day 1; and EITHER 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2 tablets, PO BID from the evening of Day 1 through the morning of Day 15.
915899|NCT01041404|E1|Reported Event|Fluoropyrimidine/Cisplatin (FP)|Participants received fluoropyrimidine (EITHER 5-FU or capecitabine, at the investigator’s discretion) and cisplatin once every 3 weeks (one cycle) for a maximum of 6 cycles as follows: cisplatin 80 mg/m^2, IV, on Day 1 and EITHER: 5-FU 800 mg/m^2 continuous IV infusion on Days 1 through 5 OR capecitabine 1000 mg/m^2, tablets, PO, BID from the evening of Day 1 through the morning of Day 15.
915900|NCT01041287|B3|Baseline|Total|Total of all reporting groups
916081|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
915901|NCT01041287|B2|Baseline|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for 3 months. They crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915902|NCT01041287|B1|Baseline|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for 3 months. They crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915903|NCT01041287|P2|Participant Flow|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915904|NCT01041287|P1|Participant Flow|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915905|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915906|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915907|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915908|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915909|NCT01041287|O2|Outcome|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915910|NCT01041287|O1|Outcome|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915911|NCT01041287|E2|Reported Event|Metoprolol/Nebivolol|"Subjects were randomized to metoprolol succinate for the first 3 months. Then they crossed over to take 3 months of nebivolol. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915912|NCT01041287|E1|Reported Event|Nebivolol/ Metoprolol|"Subjects were randomized to nebivolol for the first 3 months. Then they crossed over to take 3 months of metoprolol succinate. The initial 5 mg daily dose of nebivolol was titrated to 10 mg daily after 2 weeks if their BP remained >125/80, and subsequently titrated to 20 mg daily after another 2 weeks if the BP remained >125/80. Similarly, the initial 50 mg daily dose of metoprolol succinate was titrated to 100 mg daily after 2 weeks if BP remained >125/80, and further increased to 200 mg after 2 weeks if BP remained >125/80."
915913|NCT01041209|B3|Baseline|Total|Total of all reporting groups
915914|NCT01041209|B2|Baseline|Guideline|Enforced guidelines
915915|NCT01041209|B1|Baseline|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
915916|NCT01041209|P2|Participant Flow|Guideline|Use of antibiotics according to local enforced guidelines
915917|NCT01041209|P1|Participant Flow|Bacterial Pneumonia Score (BPS)|Use of antibiotics according to Bacterial Pneumonia Score (BPS) guidance (antibiotic use when BPS > or = 4 points)
915921|NCT01041209|O1|Outcome|Bacterial Pneumonia Score (BPS)|Indication of antibiotics according to Bacterial Pneumonia Score (BPS) guidance. Antibiotics were indicated with BPS >= 4 points
915922|NCT01041209|E2|Reported Event|Guideline|Enforced guidelines
915923|NCT01041209|E1|Reported Event|Bacterial Pneumonia Score (BPS)|Bacterial Pneumonia Score (BPS) guidance
915924|NCT01040871|B3|Baseline|Total|Total of all reporting groups
915925|NCT01040871|B2|Baseline|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915926|NCT01040871|B1|Baseline|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915927|NCT01040871|P2|Participant Flow|R-CHOP|R-CHOP received rituximab 375 mg/m2IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, vincristine 1.4 mg/m2 (maximum total of 2 mg) IV on Day 1, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.Prednisone
915928|NCT01040871|P1|Participant Flow|VR-CAP|VR-CAP arm received rituximab 375 mg/m2 IV on Day 1, cyclophosphamide 750 mg/m2 IV on Day 1, doxorubicin 50 mg/m2 IV on Day 1, VELCADE 1.3 mg/m2 IV on Days 1, 4, 8, and 11, and prednisone 100 mg/m2 orally on Days 1 through 5 of each 21-day (3-week) cycle for up to 6 cycles.
915929|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915930|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915931|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915932|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915933|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915934|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915935|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915936|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915937|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915938|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915939|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915940|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915941|NCT01040871|O2|Outcome|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915942|NCT01040871|O1|Outcome|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915943|NCT01040871|E2|Reported Event|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
915944|NCT01040871|E1|Reported Event|VR-CAP|VELCADE, Rituximab, Cyclophosphamide, Doxorubicin and Prednisone
915945|NCT01040858|B3|Baseline|Total|Total of all reporting groups
915946|NCT01040858|B2|Baseline|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915947|NCT01040858|B1|Baseline|Cognitive Strategies Group|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915948|NCT01040858|P2|Participant Flow|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915949|NCT01040858|P1|Participant Flow|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915950|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915951|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915952|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915953|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915954|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915955|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915956|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915957|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
916082|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
944935|NCT00966186|B2|Baseline|Rotational Technique|
915958|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915959|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915960|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915961|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915962|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915963|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915964|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915965|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915966|NCT01040858|O2|Outcome|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915967|NCT01040858|O1|Outcome|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915968|NCT01040858|O2|Outcome|Placebo|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915969|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915970|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915971|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915972|NCT01040858|O2|Outcome|Placebo Comparison Group|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915973|NCT01040858|O1|Outcome|Cognitive Strategies Training|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915974|NCT01040858|E2|Reported Event|Arm 2|Placebo comparison group continued to receive usual care and did not receive Cognitive Strategies training duirng their participation in the study. They were, however, offered to receive the training at the end of their participation in the study.
915975|NCT01040858|E1|Reported Event|Arm 1|Participants in the experimental group received the Cognitive Strategies intervention during their participation in the study. Cognitive Strategies Training consisted of weekly 120-minute group sessions for 10 weeks.
915976|NCT01040845|B3|Baseline|Total|Total of all reporting groups
915977|NCT01040845|B2|Baseline|Oral Contraceptive With Colchicine Then Placebo|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
915978|NCT01040845|B1|Baseline|Oral Contraceptive With Placebo Then Colchicine|All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles. On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one capsule of study drug (either over-encapsulated colchicine tablets 0.6 mg or a matching placebo capsule) twice daily in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample).
915990|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
946421|NCT00962585|E4|Reported Event|Placebo|Placebo treatment arm
916019|NCT01040793|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
915979|NCT01040845|P2|Participant Flow|Oral Contraceptive With Colchicine Then Placebo|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (over-encapsulated colchicine tablets 0.6 mg during or matching placebo capsule during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
915980|NCT01040845|P1|Participant Flow|Oral Contraceptive With Placebo Then Colchicine|[All subjects received each of the two study treatments in a randomly assigned sequence of two dosing cycles.] On the mornings of Days 1 to 20 of each cycle, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one capsule of study drug (matching placebo capsule during the first cycle or over-encapsulated colchicine tablets 0.6 mg during the second cycle) twice daily. On Day 21 of each cycle, subjects received a single dose of study drug and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of study drug with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 to 28.
915981|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915982|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915983|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915984|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915985|NCT01040845|O1|Outcome|Norethindrone With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915986|NCT01040845|O1|Outcome|Colchicine With Norethindrone/Ethinyl Estradiol|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915987|NCT01040845|O1|Outcome|Ethinyl Estradiol With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915988|NCT01040845|O1|Outcome|Ethinyl Estradiol With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915989|NCT01040845|O1|Outcome|Norethindrone With Placebo|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20, subjects additionally took one placebo capsule twice daily in the morning and with dinner. On Day 21, subjects received a single dose of placebo and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of placebo with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
916005|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
915991|NCT01040845|E1|Reported Event|Oral Contraceptive With Colchicine|On the mornings of Days 1 to 20, each subject took one active tablet of Ortho-Novum 1/35. On Days 8 to 20 of each cycle, subjects additionally took one colchicine tablet 0.6 mg (over-encapsulated to match placebo) twice daily, in the morning and with dinner. On Day 21 of each cycle, subjects received a single dose of colchicine 0.6 mg and a single active tablet of Ortho-Novum 1/35; then, 12 hours later, they received a second dose of colchicine 0.6 mg with a light snack. Inert Ortho-Novum 1/35 tablets were taken on Day 22 (after breakfast and the last blood sample), and then daily on Days 23 through 28.
915992|NCT01040832|B3|Baseline|Total|Total of all reporting groups
915993|NCT01040832|B2|Baseline|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
915994|NCT01040832|B1|Baseline|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
915995|NCT01040832|P2|Participant Flow|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
915996|NCT01040832|P1|Participant Flow|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
915997|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
915998|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
915999|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916000|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916001|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916002|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916003|NCT01040832|O2|Outcome|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916004|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916006|NCT01040832|O1|Outcome|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916007|NCT01040832|E2|Reported Event|Cetuximab Monotherapy|Cetuximab weekly (initial dose 400 mg/m^2 over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity of cetuximab monotherapy, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916008|NCT01040832|E1|Reported Event|Cetuximab Plus EMD 1201081|Cetuximab weekly (initial dose 400 milligram per square meter [mg/m^2] over 120 minutes followed by 250 mg/m^2 intravenous infusion over 60 minutes) and EMD 1201081 weekly (0.32 milligram per kilogram [mg/kg] by subcutaneous injection) was administered in 3-week treatment cycle until disease progression. Participants who had discontinued cetuximab due to toxicity in cetuximab monotherapy arm, continued to receive EMD 1201081 monotherapy until disease progression or participant elected to withdraw from the trial. The total treatment period was approximately 18 months.
916009|NCT01040819|B3|Baseline|Total|Total of all reporting groups
916010|NCT01040819|B2|Baseline|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
916011|NCT01040819|B1|Baseline|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
916012|NCT01040819|P2|Participant Flow|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
916013|NCT01040819|P1|Participant Flow|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
916014|NCT01040819|O2|Outcome|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
916015|NCT01040819|O1|Outcome|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
916016|NCT01040819|E2|Reported Event|Pioglitazone 30 mg/d|Patients will receive PIO 15 mg/d for one month. Then, dose will be increased to 30 mg/d for an additional month. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.
916017|NCT01040819|E1|Reported Event|Pioglitazone 15 mg|"Patients will receive PIO 15 mg/d for two months. Serum and urine samples for 6-keto-PGF1a and 15-epi-lipoxin A4 will be taken at baseline, one month and 2 months.~Pioglitazone: Patients will receive PIO 15 mg/d for one month, then 55 patients will continue with the same dose for one additional month, and in 55 patients the dose will be increased to 30 mg/d for an additional one month. While on PIO, other non-diabetes drugs should not be changed, unless emergency. Other hypoglycemic agents, including insulin may be adjusted, if clinically indicated. NSAID, COX2 inhibitors, aspirin >162 mg/d, steroids and prostaglandin analogs will be prohibited. At baseline, and after 1, and 2 months of treatment the following samples will be taken: 1. Serum for lipid profile, ALT, AST, CK, creatinine, BUN, glucose, HbA1c (the biochemistry laboratory at UTMB) 2. Serum for 6-keto-PGF1a and 15-epi-lipoxin A4 3. Serum for hs-CRP 4. Urine for creatinine, 6-keto-PGF1a and 15-epi-lipoxin A4"
916018|NCT01040793|B1|Baseline|Overall Study|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
916076|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916020|NCT01040793|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916021|NCT01040793|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
916022|NCT01040793|P3|Participant Flow|Olo 5mcg/ Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916023|NCT01040793|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916024|NCT01040793|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916025|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916026|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916027|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916028|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916029|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916030|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916031|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916032|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916033|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916034|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916035|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916036|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916037|NCT01040793|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916038|NCT01040793|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916039|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916040|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916041|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916042|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916043|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916044|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916045|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916046|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916047|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916048|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916049|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916050|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916051|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916052|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916053|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916054|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916055|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916056|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916057|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916058|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916059|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916060|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916061|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916062|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916063|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916064|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916065|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916066|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916067|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916068|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916069|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916070|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916071|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916072|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916073|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916074|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916075|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916083|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916084|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916088|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916089|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916090|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916091|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916092|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916093|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916094|NCT01040793|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916095|NCT01040793|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916096|NCT01040793|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916097|NCT01040793|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916098|NCT01040793|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916099|NCT01040793|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916100|NCT01040780|B3|Baseline|Total|Total of all reporting groups
916101|NCT01040780|B2|Baseline|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
916102|NCT01040780|B1|Baseline|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
916103|NCT01040780|P2|Participant Flow|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
916104|NCT01040780|P1|Participant Flow|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
916105|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
916106|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
916107|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
916108|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
916109|NCT01040780|O2|Outcome|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
916110|NCT01040780|O1|Outcome|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
916111|NCT01040780|O2|Outcome|Gefitinib|250 mg daily by mouth
916112|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
916113|NCT01040780|O2|Outcome|Gefitinib|250 mg every 24 hours by mouth
916114|NCT01040780|O1|Outcome|Icotinib|125 mg three times daily (375 mg per day) by mouth
916115|NCT01040780|E2|Reported Event|Gefitinib|Gefitinib 250 mg every 24 hours by mouth
916116|NCT01040780|E1|Reported Event|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth
916117|NCT01040728|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 122 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
916118|NCT01040728|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|"Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
916119|NCT01040728|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|"Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
916120|NCT01040728|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|"Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
916121|NCT01040728|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|"Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period.~Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler."
916122|NCT01040728|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
916123|NCT01040728|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916124|NCT01040728|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916125|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916126|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916127|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916128|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916129|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916130|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916131|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916132|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916133|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916134|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916135|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916136|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916137|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916138|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
920576|NCT01028222|O2|Outcome|DTIC|850 mg/m2 IV every 3 weeks
916139|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916140|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916141|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916142|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916143|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916144|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916145|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916146|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916147|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916148|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916149|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916150|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916151|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916152|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916153|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916154|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916155|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916156|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916157|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916158|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916159|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916160|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916161|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916162|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916163|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916164|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916165|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916166|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916167|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916168|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916169|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916170|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916171|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
916172|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916173|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916174|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916175|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916176|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916177|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916178|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916179|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916180|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916181|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916182|NCT01040728|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
916183|NCT01040728|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916184|NCT01040728|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916185|NCT01040728|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
916186|NCT01040728|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
916187|NCT01040728|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916188|NCT01040728|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916189|NCT01040728|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
916238|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916239|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916240|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916241|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916242|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916243|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916244|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning delivered by the Respimat Inhaler.
916245|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916190|NCT01040689|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 108 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Tiotropium (Tio) 18 mcg once daily (qd) delivered via the HandiHaler or equivalent placebo. The duration of each treatment period was 6 weeks with a 3 week washout period between treatments.
916191|NCT01040689|P4|Participant Flow|Tio 18mcg / Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Tiotropium 18 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
916192|NCT01040689|P3|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg / Tio 18mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Olodaterol 5 mcg qd in the third period and Tiotropium 18 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
916193|NCT01040689|P2|Participant Flow|Olo 5mcg / Olo 10mcg / Tio 18mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period, Tiotropium 18 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
916194|NCT01040689|P1|Participant Flow|Placebo / Tio 18mcg / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Tiotropium 18 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Tiotropium was administered via the HandiHaler.
916195|NCT01040689|O4|Outcome|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
916196|NCT01040689|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916197|NCT01040689|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916198|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916199|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916200|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916201|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916202|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916203|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916204|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916205|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916206|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916207|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916208|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916209|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916210|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916211|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916212|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916213|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916214|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916215|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916216|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916217|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916218|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916219|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916220|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916221|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916222|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916223|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916224|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916225|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916226|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916227|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916228|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916229|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916230|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916231|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916232|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916233|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916234|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916235|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916236|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916237|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916246|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916247|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916248|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916249|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916250|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916251|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium 18 mcg qd (morning) delivered by the HandiHaler
916252|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916253|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916254|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916255|NCT01040689|O4|Outcome|Tio 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
916256|NCT01040689|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916257|NCT01040689|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916258|NCT01040689|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916259|NCT01040689|E4|Reported Event|Tiotropium (Tio) 18 mcg qd|Tiotropium (Tio) 18 mcg qd (morning) delivered by the HandiHaler
916260|NCT01040689|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916261|NCT01040689|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916262|NCT01040689|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler or Handihaler.
916263|NCT01040624|B3|Baseline|Total|Total of all reporting groups
916264|NCT01040624|B2|Baseline|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
916265|NCT01040624|B1|Baseline|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
916266|NCT01040624|P2|Participant Flow|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
916267|NCT01040624|P1|Participant Flow|HR-A|"< 15% risk of + lymph nodes (LN)~< 15% risk of + LN: Total of 54 Cobalt gray equivalent (CGE) over 30 treatments to prostate + seminal vesicles (SV), then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during radiation therapy (RT) followed by androgen deprivation therapy for 6 months."
916268|NCT01040624|O2|Outcome|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
916269|NCT01040624|O1|Outcome|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
916270|NCT01040624|E2|Reported Event|HR-B|"> 15% risk of + LN~> 15% risk of + LN: Total of 45 Gy over 25 treatments to prostate + SV + LN, then proton boost total of 32.4-36 CGE over 18-20 treatments to prostate + SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
916271|NCT01040624|E1|Reported Event|HR-A|"< 15% risk of + LN~< 15% risk of + LN: Total of 54 CGE over 30 treatments to prostate + SV, then proton boost total of 23.4-27 CGE over 13-15 treatments to prostate +/- SV. Low dose docetaxel every week during RT followed by androgen deprivation therapy for 6 months."
916272|NCT01040403|B1|Baseline|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
916273|NCT01040403|P1|Participant Flow|Overall Study|"A randomised, double-blind, 8 treatment, 4 period, incomplete crossover study. Each treatment period was separated by a washout period of 3 weeks. The 8 treatments, administered by oral inhalation from separate Respimat inhalers, once daily, in the morning, were:~Olodaterol 5 µg and placebo~Tiotropium 1.25 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 5 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 5 µg free combination inhalation solution~Olodaterol 10 µg and placebo~Tiotropium 1.25 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 2.5 µg and Olodaterol 10 µg free combination inhalation solution~Tiotropium 5 µg and Olodaterol 10 µg free combination inhalation solution"
916274|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916275|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916276|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916277|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916278|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916279|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916280|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916281|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916282|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916283|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916284|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916285|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916286|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916287|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916288|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916289|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916290|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916291|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916292|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916293|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916294|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916295|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916296|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916297|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916298|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916299|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916300|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916301|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916302|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916303|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916304|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916305|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916306|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916307|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916308|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916309|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916310|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916311|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916312|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916313|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916314|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916315|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916316|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916317|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916318|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916319|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916320|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916321|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916322|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916323|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916324|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916325|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916326|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916327|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916328|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916329|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916330|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916331|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916332|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916333|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916334|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916335|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916336|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916337|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916338|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916339|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916340|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916341|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916342|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916343|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916344|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916345|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916346|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916347|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916348|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916349|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916350|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916351|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916352|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916353|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916354|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916355|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916356|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916357|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916358|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916359|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916360|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916361|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916362|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916363|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916364|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916365|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916366|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916367|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916368|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916369|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916370|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916371|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916372|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916373|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916374|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916375|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916376|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916377|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916378|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916379|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916380|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916381|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916382|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916383|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916384|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916385|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916386|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916387|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916388|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916389|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916390|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916391|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916392|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916393|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916394|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916395|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916396|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916397|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916398|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916399|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916400|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916401|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916402|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916403|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916404|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916405|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916406|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916407|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916408|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916409|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916410|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916411|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916412|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916413|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916414|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916415|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916416|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916417|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916418|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916419|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916420|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916421|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916422|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916423|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916424|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916425|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916426|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916427|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916428|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916429|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916430|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916431|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916432|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916433|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916434|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916435|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916436|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916437|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916438|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916439|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916440|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916441|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916442|NCT01040403|O8|Outcome|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916443|NCT01040403|O7|Outcome|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning
916444|NCT01040403|O6|Outcome|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916445|NCT01040403|O5|Outcome|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916446|NCT01040403|O4|Outcome|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916447|NCT01040403|O3|Outcome|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916448|NCT01040403|O2|Outcome|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916449|NCT01040403|O1|Outcome|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916450|NCT01040403|E8|Reported Event|T+O 5/10|Oral inhalation of Tiotropium 5 µg and Olodaterol 10 µg (Tiotropium: 2.5 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916451|NCT01040403|E7|Reported Event|T+O 2.5/10|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 10 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916452|NCT01040403|E6|Reported Event|T+O 1.25/10|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 10 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916453|NCT01040403|E5|Reported Event|Olo 10|Oral inhalation of Olodaterol 10 µg and placebo (Olodaterol: 5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916454|NCT01040403|E4|Reported Event|T+O 5/5|Oral inhalation of Tiotropium 5 µg and Olodaterol 5 µg (Tiotropium and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916455|NCT01040403|E3|Reported Event|T+O 2.5/5|Oral inhalation of Tiotropium 2.5 µg and Olodaterol 5 µg (Tiotropium: 1.25 µg per actuation and Olodaterol: 2.5 µg per actuation), as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916456|NCT01040403|E2|Reported Event|T+O 1.25/5|Oral inhalation of Tiotropium 1.25 µg and Olodaterol 5 µg (Tiotropium: 0.625 µg per actuation and Olodaterol: 2.5 µg per actuation) as free combination inhalation solution, 2 puffs from separate Respimat inhalers, once daily, in the morning.
916457|NCT01040403|E1|Reported Event|Olo 5|Oral inhalation of Olodaterol 5 µg and placebo (Olodaterol: 2.5 µg per actuation), 2 puffs from the Respimat inhaler, once daily, in the morning.
916458|NCT01040351|B3|Baseline|Total|Total of all reporting groups
916459|NCT01040351|B2|Baseline|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
916460|NCT01040351|B1|Baseline|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
916461|NCT01040351|P2|Participant Flow|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
916462|NCT01040351|P1|Participant Flow|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
916463|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
916464|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
916465|NCT01040351|O2|Outcome|2. no Aspiration|IVF-ET is done without prior aspiration of hydrosalpingeal fluid
916466|NCT01040351|O1|Outcome|1: Hydrosalpinx Needle Aspiration|After the retrieval of oocytes an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely .
916467|NCT01040351|E2|Reported Event|2. no Aspiration|IVF-ET without any prior intervention
916468|NCT01040351|E1|Reported Event|1: Hydrosalpinx Needle Aspiration|Aspiration of hydrosalpingeal fluid prior to IVF-ET
916469|NCT01040260|B3|Baseline|Total|Total of all reporting groups
916470|NCT01040260|B2|Baseline|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
916471|NCT01040260|B1|Baseline|Contingency Management|Use of tangible rewards for verified abstinence
916472|NCT01040260|P2|Participant Flow|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
916473|NCT01040260|P1|Participant Flow|Contingency Management|Use of tangible rewards for verified abstinence
916474|NCT01040260|O2|Outcome|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
916475|NCT01040260|O1|Outcome|Contingency Management|Use of tangible rewards for verified abstinence
916476|NCT01040260|E2|Reported Event|Counseling Plus Nicotine Patches|Counseling plus nicotine patches, CO testing without contingency management
916477|NCT01040260|E1|Reported Event|Contingency Management|Use of tangible rewards for verified abstinence
916478|NCT01040208|B4|Baseline|Total|Total of all reporting groups
916479|NCT01040208|B3|Baseline|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
916480|NCT01040208|B2|Baseline|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
916481|NCT01040208|B1|Baseline|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
916482|NCT01040208|P3|Participant Flow|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
916483|NCT01040208|P2|Participant Flow|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
916535|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916536|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916484|NCT01040208|P1|Participant Flow|Flibanserin 50 mg to 100 mg Qhs (Take Daily, at Bedtime)|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
916485|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
916486|NCT01040208|O2|Outcome|Flibanserin 100mg Qhs|
916487|NCT01040208|O1|Outcome|Flibanserin 50mg to 100mg Qhs|Group includes the 45 patients who took flibanserin 50 mg q.h.s. for the first 2 weeks followed by flibanserin 100 mg q.h.s.
916488|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|
916489|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|
916490|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|
916491|NCT01040208|O3|Outcome|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
916492|NCT01040208|O2|Outcome|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
916493|NCT01040208|O1|Outcome|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
916494|NCT01040208|E3|Reported Event|Placebo 2 Tablets Qhs|Patient to receive 2 flibanserin placebo tablets of 50 mg qhs
916495|NCT01040208|E2|Reported Event|Flibanserin 100 mg Qhs|Patient to receive 2 flibanserin tablets of 50 mg qhs
916496|NCT01040208|E1|Reported Event|Flibanserin 50 mg to 100 mg Qhs|Patient to receive one tablet of flibanserin 50 mg and one tablet of flibanserin placebo qhs for 14 days then will receive 2 flibanserin tablets of 50 mg qhs
916497|NCT01040169|B3|Baseline|Total|Total of all reporting groups
916498|NCT01040169|B2|Baseline|ProClude Prophylaxis Paste|
916499|NCT01040169|B1|Baseline|Nupro C Prophylaxis Paste|
916500|NCT01040169|P2|Participant Flow|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
916501|NCT01040169|P1|Participant Flow|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
916502|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
916503|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
916504|NCT01040169|O2|Outcome|ProClude Prophylaxis Paste|
916505|NCT01040169|O1|Outcome|Nupro C Prophylaxis Paste|
916506|NCT01040169|E2|Reported Event|ProClude Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
916507|NCT01040169|E1|Reported Event|Nupro C Prophylaxis Paste|single, unit dose application professionally applied to the teeth (by a dentist)at the beginning of the study
916508|NCT01040130|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 3-way crossover trial. 151 patients were assigned randomly to one of 3 treatment sequences in which they received each of 3 treatments. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
916509|NCT01040130|P6|Participant Flow|Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
916510|NCT01040130|P5|Participant Flow|Olo 10mcg / Placebo / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916511|NCT01040130|P4|Participant Flow|Olo 5mcg / Olo 10mcg / Placebo|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 10 mcg qd in the second period and placebo in the third period. Olodaterol was administered via the Respimat inhaler.
916512|NCT01040130|P3|Participant Flow|Olo 5mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, placebo in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916513|NCT01040130|P2|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg|Patients were administered placebo in the first period, Olodaterol 10 mcg qd in the second period and Olodaterol 5 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916514|NCT01040130|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period and Olodaterol 10 mcg qd in the third period. Olodaterol was administered via the Respimat inhaler.
916515|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916516|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916517|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916518|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916519|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916520|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916521|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916522|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916523|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916524|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916525|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916526|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916527|NCT01040130|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916528|NCT01040130|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916529|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916530|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916531|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916532|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916533|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916534|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916537|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916538|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916539|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916540|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916541|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916542|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916543|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916544|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916545|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916546|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916547|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916548|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916549|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916550|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916551|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916552|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916553|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916554|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916555|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916556|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916557|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916558|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916559|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916560|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916561|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916562|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916563|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916564|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916565|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916566|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916567|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916568|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916569|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916570|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916571|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916572|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916573|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916574|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916575|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916576|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916577|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916578|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916579|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916580|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916581|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916582|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916583|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916584|NCT01040130|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
916585|NCT01040130|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
916586|NCT01040130|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916587|NCT01040130|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
916588|NCT01040130|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
916589|NCT01040130|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
916590|NCT01040052|B1|Baseline|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
916591|NCT01040052|P1|Participant Flow|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
916592|NCT01040052|O1|Outcome|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
916593|NCT01040052|E1|Reported Event|ADACEL® Vaccine Group|All participants received a single dose of ADACEL® vaccine on Day 0.
916594|NCT01039792|B3|Baseline|Total|Total of all reporting groups
916595|NCT01039792|B2|Baseline|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
916596|NCT01039792|B1|Baseline|Placebo|"Placebo~Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
916597|NCT01039792|P2|Participant Flow|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
916598|NCT01039792|P1|Participant Flow|Placebo|"Placebo~Placebo: placebo"
916599|NCT01039792|O2|Outcome|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
917097|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
916600|NCT01039792|O1|Outcome|Placebo|"Placebo~Placebo: Syringes were tightly taped with opaque material to hide the color of the liquid"
916601|NCT01039792|E2|Reported Event|Active|"Active Methyl B12~Methyl B12: 75 µg/Kg subcutaneously injected once every 3 days"
916602|NCT01039792|E1|Reported Event|Placebo|"Placebo~Placebo: placebo"
916603|NCT01039675|B3|Baseline|Total|Total of all reporting groups
916604|NCT01039675|B2|Baseline|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
916605|NCT01039675|B1|Baseline|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
916606|NCT01039675|P2|Participant Flow|UMEC/VI 500/25 µg QD|Participants received umeclidinium bromide/vilanterol (UMEC/VI) 500/25 micrograms (µg) QD via a DPI in the morning for 4 weeks.
916607|NCT01039675|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) via a dry powder inhaler (DPI) in the morning for 4 weeks.
916608|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
916609|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
916610|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
916611|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
916612|NCT01039675|O2|Outcome|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
916613|NCT01039675|O1|Outcome|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
916614|NCT01039675|E2|Reported Event|UMEC/VI 500/25 µg QD|Participants received UMEC/VI 500/25 µg QD via a DPI in the morning for 4 weeks.
916615|NCT01039675|E1|Reported Event|Placebo|Participants received matching placebo QD via a DPI in the morning for 4 weeks.
916616|NCT01039584|B4|Baseline|Total|Total of all reporting groups
916617|NCT01039584|B3|Baseline|Placebo|"vehicle of the test product~Placebo : vaginal cream"
916618|NCT01039584|B2|Baseline|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
916619|NCT01039584|B1|Baseline|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
916620|NCT01039584|P3|Participant Flow|Placebo|"vehicle of the test product~Placebo : vaginal cream"
916621|NCT01039584|P2|Participant Flow|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
916622|NCT01039584|P1|Participant Flow|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
916623|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
916624|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
916625|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
916626|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
916627|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
916628|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
916629|NCT01039584|O3|Outcome|Placebo|"vehicle of the test product~Placebo : vaginal cream"
916630|NCT01039584|O2|Outcome|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
916631|NCT01039584|O1|Outcome|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
916632|NCT01039584|E3|Reported Event|Placebo|"vehicle of the test product~Placebo : vaginal cream"
916633|NCT01039584|E2|Reported Event|Reference Product|"Gynazole 1 Vaginal Cream~Gynazole 1 vaginal cream : vaginal cream"
916634|NCT01039584|E1|Reported Event|Test Product|"Butoconazole Nitrate Vaginal Cream~Butoconazole Nitrate Vaginal Cream : vaginal cream"
916635|NCT01039519|B1|Baseline|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916636|NCT01039519|P1|Participant Flow|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916637|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916638|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916639|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916640|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916641|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916642|NCT01039519|O1|Outcome|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916682|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916643|NCT01039519|E1|Reported Event|Ganetespib 200 mg/m^2|Ganetespib (STA-9090) 200 mg/m^2 intravenous infusion once weekly for 3 consecutive weeks followed by one week dose free interval (3 weeks on and 1 week off represent a treatment cycle). Treatment continues until disease progression or unacceptable toxicity.
916644|NCT01039428|B3|Baseline|Total|Total of all reporting groups
916645|NCT01039428|B2|Baseline|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
916646|NCT01039428|B1|Baseline|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
916647|NCT01039428|P2|Participant Flow|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
916648|NCT01039428|P1|Participant Flow|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
916649|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916650|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916651|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916652|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916653|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916654|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916655|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916656|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916657|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916658|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916659|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916660|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916661|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916662|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916663|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916664|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916665|NCT01039428|O2|Outcome|Placebo|Participants chewed placebo chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916666|NCT01039428|O1|Outcome|HS219|Participants chewed HS219 chewing gum for 30 min three times a day while fasting (i.e., between meals) for 3 weeks.
916667|NCT01039428|E2|Reported Event|Placebo|Participants chewed placebo chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
916668|NCT01039428|E1|Reported Event|HS219|Participants chewed HS219 chewing gum three times a day while fasting (i.e., between meals) for 30 min for 3 weeks.
916669|NCT01039376|B3|Baseline|Total|Total of all reporting groups
916670|NCT01039376|B2|Baseline|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916671|NCT01039376|B1|Baseline|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916672|NCT01039376|P2|Participant Flow|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916673|NCT01039376|P1|Participant Flow|Ofatumumab|Participants with relapsed chronic lymphocytic leukemia (CLL) received intravenous (IV) infusions of ofatumumab on Day 1 (300 milligrams [mg]) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916674|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916675|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916676|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916677|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916678|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916679|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916680|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916739|NCT01035749|B5|Baseline|Total|Total of all reporting groups
917091|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
916681|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916683|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916684|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916685|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916686|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916687|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916688|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916689|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916690|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916691|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916692|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916693|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916694|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916695|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916696|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916697|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916698|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916699|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916700|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916701|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916702|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916703|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916704|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916705|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916706|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916707|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916708|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916709|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916710|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916711|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916712|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916713|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916714|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
917092|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
916715|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916716|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916717|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916718|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916719|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916720|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916721|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916722|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916723|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916724|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916725|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916726|NCT01039376|O2|Outcome|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916727|NCT01039376|O1|Outcome|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916728|NCT01039376|E2|Reported Event|Observation|Participants with relapsed CLL received no treatment and were under observation for up to 2 years.
916729|NCT01039376|E1|Reported Event|Ofatumumab|Participants with relapsed CLL received IV infusions of ofatumumab on Day 1 (300 mg) and Day 8 (1000 mg) in the first cycle, followed by infusions of 1000 mg every 2 months for up to 2 years following the first 1000 mg dose.
916730|NCT01035788|B3|Baseline|Total|Total of all reporting groups
916731|NCT01035788|B2|Baseline|Cognitive Behavioral Conjoint Therapy Communication Skills|"Psychoeducational Intervention~Psychoeducation (control): This control intervention will provide psychoeducation including the communication content from sessions 1-7 of cognitive behavioral conjoint therapy for PTSD."
916732|NCT01035788|B1|Baseline|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD: This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive behavioral conjoint therapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
916733|NCT01035788|P2|Participant Flow|Cognitive Behavioral Conjoint Therapy Communication Skills|Cognitive-Behavioral Conjoint Therapy (CBCT) phases 1-2 communications skills training (no PTSD psychoeducation) offered during a weekend couple retreat followed by two monthly group couple sessions for skills review.
916734|NCT01035788|P1|Participant Flow|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy for PTSD (MB-CBCT) is an adaptation of Cognitive-Behavioral Conjoint Therapy for PTSD (CBCT) that offers CBCT Phases 1 and 2 plus mindfulness training in a couple weekend retreat format, followed by continued use of mindfulness skills in session and for out of session practice during one transition couple therapy session, followed by CBCT Phase 3 couple sessions.
916735|NCT01035788|O2|Outcome|Cognitive Behavioral Conjoint Therapy Communication Skills|"Cognitive-Behavioral Conjoint Therapy for PTSD - Communication Skills~This control intervention will provide communication skills training from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
916736|NCT01035788|O1|Outcome|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~This intervention combines cognitive behavioral conjoint therapy for PTSD and mindfulness skills. Cognitive Behavioral ConjointTtherapy for PTSD includes psychoeducation, skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
916737|NCT01035788|E2|Reported Event|Cognitive Behavioral Conjoint Therapy Communication Skills|"CBCT for PTSD - Communication Skills~CBCT for PTSD - Communication Skills: This control intervention will provide psychoeducation including the communication skills content from sessions 1-7 of Cognitive Behavioral Conjoint Therapy for PTSD."
916738|NCT01035788|E1|Reported Event|Mindfulness-Based Cognitive-Behavioral Conjoint Therapy|"Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD~Mindfulness Based Cognitive Behavioral Conjoint Therapy: This intervention combines Cognitive Behavioral Conjoint Therapy for PTSD and mindfulness skills. Cognitive Behavioral Conjoint Therapy for PTSD includes PTSD psychoeducation, communication skills training and cognitive restructuring. Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses."
916740|NCT01035749|B4|Baseline|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916741|NCT01035749|B3|Baseline|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916742|NCT01035749|B2|Baseline|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916743|NCT01035749|B1|Baseline|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916744|NCT01035749|P4|Participant Flow|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916745|NCT01035749|P3|Participant Flow|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916746|NCT01035749|P2|Participant Flow|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916747|NCT01035749|P1|Participant Flow|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916748|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916749|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916750|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916751|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916752|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916753|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916754|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916755|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916756|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916757|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916758|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916759|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916760|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916761|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916762|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916763|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916764|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916765|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916766|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916767|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916768|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916769|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916770|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916771|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916772|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916773|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916774|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916775|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916901|NCT01038921|E2|Reported Event|Placebo First|Cross-over design for subjects randomized to Placebo First, Melatonin Second
916776|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916777|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916778|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916779|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916780|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916781|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916782|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916783|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916784|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916785|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916786|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916787|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916788|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916789|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916790|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916791|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916792|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916793|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916794|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916795|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916796|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916797|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916798|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916799|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916800|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916801|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916802|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916803|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916804|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916805|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916806|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916807|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916808|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916809|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916810|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916811|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916812|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916813|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916814|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916815|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916816|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916817|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916818|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916819|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916820|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916821|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916822|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916823|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916824|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916825|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916826|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916827|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916828|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916829|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916830|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916831|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916832|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916833|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916834|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916835|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916836|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916837|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916838|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916839|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916840|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916841|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916842|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916843|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916844|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916845|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916846|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916847|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916848|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916849|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916850|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916851|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916852|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916853|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916854|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916855|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916856|NCT01035749|O4|Outcome|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916857|NCT01035749|O3|Outcome|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916858|NCT01035749|O2|Outcome|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916859|NCT01035749|O1|Outcome|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916860|NCT01035749|E4|Reported Event|Arepanrix-unadjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ unadjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916861|NCT01035749|E3|Reported Event|Arepanrix-adjuvanted F2 3D Group|Subjects received 3 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0, Day 21 and Day 182 (booster).
916862|NCT01035749|E2|Reported Event|Arepanrix-adjuvanted F2 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 2 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916863|NCT01035749|E1|Reported Event|Arepanrix-adjuvanted F1 2D Group|Subjects received 2 doses of Arepanrix ™ formulation 1 adjuvanted vaccine on Day 0 and Day 182 (booster) and one dose of saline placebo on Day 21.
916864|NCT01035658|B5|Baseline|Total|Total of all reporting groups
916865|NCT01035658|B4|Baseline|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916866|NCT01035658|B3|Baseline|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916867|NCT01035658|B2|Baseline|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916868|NCT01035658|B1|Baseline|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916869|NCT01035658|P4|Participant Flow|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916898|NCT01038921|P1|Participant Flow|Melatonin|Cross-over design with subject receiving either Melatonin First and Placebo Second or Placebo First and Melatonin Second
917093|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
916902|NCT01038921|E1|Reported Event|Melatonin First|Cross-over design for subjects randomized to Melatonin First, Placebo Second
916903|NCT01038869|B1|Baseline|Finacea|Open label pilot study
916870|NCT01035658|P3|Participant Flow|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916871|NCT01035658|P2|Participant Flow|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916872|NCT01035658|P1|Participant Flow|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916873|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916874|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916875|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916876|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916877|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916878|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916879|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916880|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916881|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916899|NCT01038921|O2|Outcome|Placebo|Cross-over design for all subjects on Placebo for 10 weeks measured at baseline and at 10 weeks.
916882|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916883|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916884|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916885|NCT01035658|O4|Outcome|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916886|NCT01035658|O3|Outcome|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916887|NCT01035658|O2|Outcome|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916888|NCT01035658|O1|Outcome|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916889|NCT01035658|O1|Outcome|Phase 1|All patients in Phase I (this section contains the Maximum Tolerated Dose)
916890|NCT01035658|E4|Reported Event|Dose Level 2 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (40mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916891|NCT01035658|E3|Reported Event|Dose Level 1 Sequential|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). In this schedule, liposomal doxorubicin (30mg) was given on day 1, and pazopanib (400mg) was given days 3 - 26 of each 28 day cycle. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916892|NCT01035658|E2|Reported Event|Dose Level -1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (30mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916893|NCT01035658|E1|Reported Event|Dose Level 1|"Systemic therapy with pazopanib and liposomal doxorubicin (Doxil). Single-agent pazopanib will be given for a 7 day run-in period, followed by a combination of pazopanib (400mg) and liposomal doxorubicin (40mg) administered in 28-day treatment cycles. Cycles will continue until disease progression, unacceptable toxicity or withdrawal.~Pazopanib: All patients will begin treatment with a 7-day run in period of single-agent pazopanib. Patients will receive pazopanib orally days 1-28 of a 28 day cycle.~Doxil: Liposomal doxorubicin (Doxil) will be administered IV on day 1 of a 28-day treatment cycle"
916894|NCT01038921|B3|Baseline|Total|Total of all reporting groups
916895|NCT01038921|B2|Baseline|Placebo First|Cross-over design with subjects receiving Placebo First
916896|NCT01038921|B1|Baseline|Melatonin First|Cross-over design with subjects receiving Melatonin First
916897|NCT01038921|P2|Participant Flow|Placebo|Cross-over design with subjects receiving either Placebo First and Melatonin Second or Melatonin First and Placebo Second
916900|NCT01038921|O1|Outcome|Melatonin|Cross-over design for subjects on Melatonin for 10 weeks measured at baseline and 10 weeks
916904|NCT01038869|P1|Participant Flow|Finacea|Open label pilot study. All subjects were given Azelaic acid 15% to be used topically, twice daily.
916905|NCT01038869|O1|Outcome|Azelaic Acid 15%|tolerability assessments
916906|NCT01038869|O1|Outcome|Azelaic Acid 15%|lesion counts
916907|NCT01038869|O1|Outcome|Azelaic Acid 15%|
916908|NCT01038869|O1|Outcome|Azelaic Acis 15% Open Label|Assessments of PIH IGA
916909|NCT01038869|O1|Outcome|Azelaic Acid 15% Open Label|Assessments of IGA
916910|NCT01038869|E1|Reported Event|Finacea|Open label pilot study
916911|NCT01038752|B3|Baseline|Total|Total of all reporting groups
916912|NCT01038752|B2|Baseline|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916913|NCT01038752|B1|Baseline|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916914|NCT01038752|P2|Participant Flow|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo, Docetaxel, Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916915|NCT01038752|P1|Participant Flow|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin, Docetaxel, Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916916|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916917|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916918|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916919|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916920|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916921|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916922|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916923|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916924|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916925|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916945|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916946|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916926|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916927|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916928|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916929|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916930|NCT01038752|O2|Outcome|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916931|NCT01038752|O1|Outcome|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916932|NCT01038752|E2|Reported Event|Standard of Care|"This group will receive placebo with docetaxel and carboplatin.~Placebo + Docetaxel + Carboplatin: Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916933|NCT01038752|E1|Reported Event|Suramin|"This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin.~Suramin + Docetaxel + Carboplatin: Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour)."
916934|NCT01038713|B4|Baseline|Total|Total of all reporting groups
916935|NCT01038713|B3|Baseline|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916936|NCT01038713|B2|Baseline|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916937|NCT01038713|B1|Baseline|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916938|NCT01038713|P3|Participant Flow|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916939|NCT01038713|P2|Participant Flow|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916940|NCT01038713|P1|Participant Flow|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916941|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916942|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916943|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916944|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916975|NCT01038635|P3|Participant Flow|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
916947|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916948|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916949|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916950|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916951|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916952|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916953|NCT01038713|O3|Outcome|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916954|NCT01038713|O2|Outcome|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916955|NCT01038713|O1|Outcome|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916956|NCT01038713|E3|Reported Event|Resectable; Fully Covered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a fully-covered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916957|NCT01038713|E2|Reported Event|Resectable; Uncovered Metal Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive an uncovered metal biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916958|NCT01038713|E1|Reported Event|Resectable; Plastic Stent|"Patients determined to have surgically resectable malignancy presenting with malignant biliary obstruction randomized to receive a plastic biliary stent to relieve their biliary obstruction.~Biliary stent placement: Patient's with a malignant biliary obstruction will undergo placement of a biliary stent via ERCP."
916959|NCT01038635|B10|Baseline|Total|Total of all reporting groups
916960|NCT01038635|B9|Baseline|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
916961|NCT01038635|B8|Baseline|Phase II: 5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
916962|NCT01038635|B7|Baseline|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
916963|NCT01038635|B6|Baseline|5-AZA + LEN 75 mg 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
916964|NCT01038635|B5|Baseline|5-AZA + 50 LEN|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
916965|NCT01038635|B4|Baseline|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
916966|NCT01038635|B3|Baseline|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
916967|NCT01038635|B2|Baseline|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days
916968|NCT01038635|B1|Baseline|5-AZA + LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days
916969|NCT01038635|P9|Participant Flow|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
916970|NCT01038635|P8|Participant Flow|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
916971|NCT01038635|P7|Participant Flow|5-AZA + LEN 75 mg for 10 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
916972|NCT01038635|P6|Participant Flow|5-AZA + LEN 75 mg for 5 Days|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
916973|NCT01038635|P5|Participant Flow|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
916974|NCT01038635|P4|Participant Flow|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
917089|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
916976|NCT01038635|P2|Participant Flow|5-AZA + LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
917094|NCT01038323|O1|Outcome|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
917095|NCT01038323|O3|Outcome|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
916977|NCT01038635|P1|Participant Flow|5-AZA + LEN 10 mg|Phase I: 5-Azacytidine (5-AZA) + Lenalidomide (LEN): 5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
916978|NCT01038635|O1|Outcome|Overall Study: 5-AZA + LEN MTD|Combined reporting for all phases, Phase I (5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10) and Phase II All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
916979|NCT01038635|O2|Outcome|Phase II: 5-AZA + LEN|All subjects received 75mg/m²/day AZA days 1-5 of each 28-day cycle. LEN 50 mg was administered orally for 10 days, with dose later amended to LEN 25 mg daily for 5 days.
916980|NCT01038635|O1|Outcome|Phase I: 5-AZA + LEN MTD|5-Azacytidine 75 mg/m^2 by vein daily x 5 days on days 1 to 5 of each 28-day cycle. Lenalidomide starting dose 10 mg orally daily x 5 days on days 6 to 10.
916981|NCT01038635|O7|Outcome|5-AZA + 10 Days LEN 75 mg 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
916982|NCT01038635|O6|Outcome|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
916983|NCT01038635|O5|Outcome|5-AZA + 5 Days LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
916984|NCT01038635|O4|Outcome|5-AZA + 5 Days LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
916985|NCT01038635|O3|Outcome|5-AZA + 5 Days LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
916986|NCT01038635|O2|Outcome|5-AZA + 5 Days LEN 15 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
916987|NCT01038635|O1|Outcome|5-AZA + 5 Days LEN 10 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
916988|NCT01038635|E9|Reported Event|Phase II: AZA+ LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg daily for 5 days.
916989|NCT01038635|E8|Reported Event|Phase II: AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 10 days.
916990|NCT01038635|E7|Reported Event|5-AZA + 10 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 10 days.
916991|NCT01038635|E6|Reported Event|5-AZA + 5 Days LEN 75 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 75 mg orally for 5 days.
916992|NCT01038635|E5|Reported Event|5-AZA + LEN 50 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 50 mg orally for 5 days.
916993|NCT01038635|E4|Reported Event|5-AZA + LEN 25 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 25 mg orally for 5 days.
916994|NCT01038635|E3|Reported Event|5-AZA + LEN 20 mg|5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 20 mg orally for 5 days.
916995|NCT01038635|E2|Reported Event|5-AZA + LEN 15 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 15 mg orally for 5 days.
916996|NCT01038635|E1|Reported Event|5-AZA + LEN 10 mg|Phase I: 5-AZA 75 mg/m²/day Days 1-5 of each 28-day cycle + LEN 10 mg orally for 5 days.
916997|NCT01038609|B6|Baseline|Total|Total of all reporting groups
916998|NCT01038609|B5|Baseline|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
916999|NCT01038609|B4|Baseline|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917000|NCT01038609|B3|Baseline|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917001|NCT01038609|B2|Baseline|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917002|NCT01038609|B1|Baseline|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917003|NCT01038609|P5|Participant Flow|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917004|NCT01038609|P4|Participant Flow|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917005|NCT01038609|P3|Participant Flow|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917006|NCT01038609|P2|Participant Flow|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917007|NCT01038609|P1|Participant Flow|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917008|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917096|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
920577|NCT01028222|O1|Outcome|Nilotinib|400 mg twice daily
917009|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917010|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917011|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917012|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917013|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917014|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917015|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917016|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917017|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917018|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917019|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917020|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917021|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917022|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917023|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917024|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917025|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917026|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917027|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917028|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917029|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917030|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917031|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917032|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917033|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917034|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917035|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917036|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917037|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917038|NCT01038609|O5|Outcome|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917039|NCT01038609|O4|Outcome|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet plus 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917040|NCT01038609|O3|Outcome|Morphine Extended Release / Acetaminophen|1 dose of 1 morphine extended release capsule plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917041|NCT01038609|O2|Outcome|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) plus 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917042|NCT01038609|O1|Outcome|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917043|NCT01038609|E5|Reported Event|Placebo|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917044|NCT01038609|E4|Reported Event|Hydrocodone/Acetaminophen Extended Release|1 dose of 1 hydrocodone/acetaminophen extended release tablet and 1 placebo capsule (for morphine extended release), administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917045|NCT01038609|E3|Reported Event|Morphine Extended Release/Acetaminophen|1 dose of 1 morphine extended release capsule and 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917046|NCT01038609|E2|Reported Event|Morphine Extended Release|1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release) and 1 morphine extended release capsule, administered once every 12 hours, and 1 dose of 1 placebo tablet (for hydrocodone/acetaminophen extended release), administered once every 6 hours (for a total of 8 doses).
917047|NCT01038609|E1|Reported Event|Acetaminophen|1 dose of 1 placebo capsule (for morphine extended release) plus 1 acetaminophen tablet, administered once every 12 hours, and 1 dose of 1 acetaminophen tablet, administered once every 6 hours (for a total of 8 doses).
917048|NCT01038336|B4|Baseline|Total|Total of all reporting groups
917049|NCT01038336|B3|Baseline|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
917050|NCT01038336|B2|Baseline|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation brochure: The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917051|NCT01038336|B1|Baseline|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917052|NCT01038336|P3|Participant Flow|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
917053|NCT01038336|P2|Participant Flow|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917054|NCT01038336|P1|Participant Flow|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917055|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
917056|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917090|NCT01038323|O2|Outcome|Milnacipran|Milnacipran (drug) only
917057|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917058|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
917059|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917060|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917061|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
917062|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917063|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917064|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
917065|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917066|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917067|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): Soc amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
917068|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917069|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917070|NCT01038336|O3|Outcome|Standard of Care|Standard of care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to.
917071|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917072|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917073|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention but participants are allowed to seek information about hearing loss prevention of they want to.
917074|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917075|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP)~The multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917076|NCT01038336|O3|Outcome|Standard-of-Care|Standard-of-Care (SoC): SoC amounts to no intervention, however protocol allows participants to independently seek information about hearing loss prevention if they want to..
917077|NCT01038336|O2|Outcome|Hearing Conservation Brochure|"Hearing Conservation Brochure (HCB)~The Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form."
917078|NCT01038336|O1|Outcome|Multimedia Hearing Loss Prevention Program|"Multimedia Hearing Loss Prevention Program (HLPP):~Multimedia HLPP is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans."
917079|NCT01038336|E3|Reported Event|Standard of Care|Standard of Care (SoC): SoC amounts ot no intervention although participants were allowed to seek information about hearing loss prevention if they wanted to.
917080|NCT01038336|E2|Reported Event|Hearing Conservation Brochure|Hearing Conservation Brochure (HCB). Hearing Conservation Brochure provides knowledge-based information similar to that of the multimedia HLPP, but in written form.
917081|NCT01038336|E1|Reported Event|Multimedia Hearing Loss Prevention Program|Multimedia Hearing Loss Prevention Program (HLPP) is an interactive, multimedia, computer-based HLPP that provides hands-on education and training about hearing loss, tinnitus, hearing protection, and general hearing health care for Veterans.
917082|NCT01038323|B4|Baseline|Total|Total of all reporting groups
917083|NCT01038323|B3|Baseline|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
917084|NCT01038323|B2|Baseline|Milnacipran|Milnacipran (drug) only
917085|NCT01038323|B1|Baseline|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
917086|NCT01038323|P3|Participant Flow|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) only
917087|NCT01038323|P2|Participant Flow|Milnacipran|Milnacipran (drug) only
917088|NCT01038323|P1|Participant Flow|Combination|Combination cognitive behavioral therapy (CBT) and milnacipran
917098|NCT01038323|E3|Reported Event|Cognitive Behavioral Therapy|Cognitive behavioral therapy + placebo
917099|NCT01038323|E2|Reported Event|Milnacipran|milnacipran + education
917100|NCT01038323|E1|Reported Event|Combination|Cognitive behavioral therapy + milnacipran
917101|NCT01038128|B1|Baseline|Memantine|Memantine, 10-40 mg daily
917102|NCT01038128|P1|Participant Flow|Memantine|Memantine, 10-40 mg daily
917103|NCT01038128|O1|Outcome|Baseline Data|Ratings at Baseline and Endpoint.
917104|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
917105|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
917106|NCT01038128|O1|Outcome|Memantine|Ratings at Baseline and Endpoint
917107|NCT01038128|O1|Outcome|Memantine|Number of Binge Eating and Purging Episodes at Baseline and Endpoint
917108|NCT01038128|E1|Reported Event|Memantine|Memantine, 10-40 mg daily
917109|NCT01037452|B5|Baseline|Total|Total of all reporting groups
917110|NCT01037452|B4|Baseline|Placebo|Placebo, single dose
917111|NCT01037452|B3|Baseline|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
917112|NCT01037452|B2|Baseline|PPI Alone|Lansoprazole 15 mg, single dose
917113|NCT01037452|B1|Baseline|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
917114|NCT01037452|P4|Participant Flow|Placebo|Placebo, single dose
917115|NCT01037452|P3|Participant Flow|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
917116|NCT01037452|P2|Participant Flow|PPI Alone|Lansoprazole 15 mg, single dose
917117|NCT01037452|P1|Participant Flow|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
917118|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
917119|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
917120|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
917121|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
917122|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
917123|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
917124|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
917125|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
917126|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
917127|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
917128|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
917129|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
917130|NCT01037452|O4|Outcome|Placebo|Placebo, single dose
917131|NCT01037452|O3|Outcome|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
917132|NCT01037452|O2|Outcome|PPI Alone|Lansoprazole 15 mg, single dose
917133|NCT01037452|O1|Outcome|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
917134|NCT01037452|E4|Reported Event|Placebo|Placebo, single dose
917135|NCT01037452|E3|Reported Event|Antacid Alone|Calcium carbonate/magnesium hydroxide, single dose
917136|NCT01037452|E2|Reported Event|PPI Alone|Lansoprazole 15 mg, single dose
917137|NCT01037452|E1|Reported Event|Combination Product|Calcium carbonate/magnesium hydroxide/Lansoprazole 15 mg tablet, single dose
917138|NCT01035346|B3|Baseline|Total|Total of all reporting groups
917139|NCT01035346|B2|Baseline|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917140|NCT01035346|B1|Baseline|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917141|NCT01035346|P2|Participant Flow|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917142|NCT01035346|P1|Participant Flow|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 milligram (mg) tablet.
917143|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917144|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917145|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917146|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917147|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917148|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917149|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917150|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917151|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917152|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917153|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917154|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917155|NCT01035346|O2|Outcome|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917156|NCT01035346|O1|Outcome|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917310|NCT01037244|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
917157|NCT01035346|E2|Reported Event|Ibuprofen Sodium|Single oral dose of 2 ibuprofen sodium 256 mg tablets, equivalent to 400 mg ibuprofen.
917158|NCT01035346|E1|Reported Event|Placebo|Single oral dose of 2 placebo tablets matched to ibuprofen sodium 256 mg tablet.
917159|NCT01035333|B1|Baseline|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
917160|NCT01035333|P1|Participant Flow|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
917161|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
917162|NCT01035333|O1|Outcome|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
917163|NCT01035333|E1|Reported Event|Orlistat 60mg|Patients assigned to treatment group for up to 6 months of therapy.
917164|NCT01035255|B3|Baseline|Total|Total of all reporting groups
917165|NCT01035255|B2|Baseline|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917166|NCT01035255|B1|Baseline|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917167|NCT01035255|P2|Participant Flow|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917168|NCT01035255|P1|Participant Flow|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917169|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917170|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917171|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917172|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917173|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917174|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917175|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917176|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917196|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917311|NCT01037244|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
917312|NCT01037218|B5|Baseline|Total|Total of all reporting groups
917228|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917229|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917177|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917178|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917179|NCT01035255|O2|Outcome|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917180|NCT01035255|O1|Outcome|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917181|NCT01035255|E2|Reported Event|Enalapril|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. Enalapril 10 mg BID during double blind treatment period
917182|NCT01035255|E1|Reported Event|LCZ696|single-blind active run-in period consisted of treatment with enalapril 10 mg bid, followed by LCZ696 100 mg bid, and then LCZ696 200 mg bid over a total duration of 5 to 10 weeks. Temporary down-titration from LCZ696 200 mg bid to LCZ696 100 mg bid was allowed provided the patient was up-titrated back to LCZ696 200 mg bid and tolerated this dose for at least two weeks before being eligible for randomization. LCZ696 200mg BID during double blind treatment period
917183|NCT01035229|B3|Baseline|Total|Total of all reporting groups
917184|NCT01035229|B2|Baseline|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917185|NCT01035229|B1|Baseline|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917186|NCT01035229|P2|Participant Flow|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917187|NCT01035229|P1|Participant Flow|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917188|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
917189|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917190|NCT01035229|O2|Outcome|Everolimus 5mg + Best Supportive Care (BSC)|Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed.
917191|NCT01035229|O1|Outcome|Everolimus 7.5mg + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917192|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917193|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917194|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917195|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917197|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917198|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917199|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917200|NCT01035229|O2|Outcome|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917201|NCT01035229|O1|Outcome|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917202|NCT01035229|E2|Reported Event|Placebo + Best Supportive Care|Placebo-Everolimus was taken as a daily oral dose of 7.5 mg and was defined as the control drug. In addition to taking Placebo Everolimus, all patients also received BSC as per normal local practice.
917203|NCT01035229|E1|Reported Event|Everolimus + Best Supportive Care (BSC)|Patients were assigned to the Everolimus + BSC arm in a ratio of 2:1 over the Placebo arm. Everolimus was taken as a daily oral dose of 7.5 mg but dose adjustments of study drug (reduction, interruption or possible dose re-escalation to starting dose) according to safety findings were allowed. In addition to taking Everolimus, all patients also received BSC as per normal local practice.
917204|NCT01037309|B7|Baseline|Total|Total of all reporting groups
917205|NCT01037309|B6|Baseline|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917206|NCT01037309|B5|Baseline|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917207|NCT01037309|B4|Baseline|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917208|NCT01037309|B3|Baseline|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917209|NCT01037309|B2|Baseline|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917210|NCT01037309|B1|Baseline|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917211|NCT01037309|P9|Participant Flow|Intravenous PRO044 8 mg/kg|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917212|NCT01037309|P8|Participant Flow|Intravenous PRO044 5 mg/kg|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917213|NCT01037309|P7|Participant Flow|Intravenous PRO044 1.5 mg/kg|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917214|NCT01037309|P6|Participant Flow|Subcutaneous PRO044 12 mg/kg|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917215|NCT01037309|P5|Participant Flow|Subcutaneous PRO044 10 mg/kg|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917216|NCT01037309|P4|Participant Flow|Subcutaneous PRO044 8 mg/kg|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917217|NCT01037309|P3|Participant Flow|Subcutaneous PRO044 5 mg/kg|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917218|NCT01037309|P2|Participant Flow|Subcutaneous PRO044 1.5 mg/kg|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917219|NCT01037309|P1|Participant Flow|Subcutaneous PRO044 0.5 mg/kg|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917220|NCT01037309|O9|Outcome|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917221|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917222|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917223|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917224|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917225|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917226|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917227|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917289|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917230|NCT01037309|O8|Outcome|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917231|NCT01037309|O7|Outcome|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917232|NCT01037309|O6|Outcome|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917233|NCT01037309|O5|Outcome|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917234|NCT01037309|O4|Outcome|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917235|NCT01037309|O3|Outcome|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917236|NCT01037309|O2|Outcome|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917237|NCT01037309|O1|Outcome|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917238|NCT01037309|E9|Reported Event|PRO044, Cohort 9|"Intravenous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917239|NCT01037309|E8|Reported Event|PRO044, Cohort 8|"Intravenous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917240|NCT01037309|E7|Reported Event|PRO044, Cohort 7|"Intravenous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29~PRO044 IV: Intravenous injection, once a week, for five weeks"
917241|NCT01037309|E6|Reported Event|PRO044, Cohort 6|"Subcutaneous injection of maximally 12 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917242|NCT01037309|E5|Reported Event|PRO044, Cohort 5|"Subcutaneous injection of maximally 10 mg/kg on day 1, 8, 15, 22 and 29~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917243|NCT01037309|E4|Reported Event|PRO044, Cohort 4|"Subcutaneous injection of maximally 8 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917244|NCT01037309|E3|Reported Event|PRO044, Cohort 3|"Subcutaneous injection of maximally 5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917245|NCT01037309|E2|Reported Event|PRO044, Cohort 2|"Subcutaneous injection of maximally 1.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917246|NCT01037309|E1|Reported Event|PRO044, Cohort 1|"Subcutaneous injection of 0.5 mg/kg on day 1, 8, 15, 22 and 29.~PRO044 SC: Subcutaneous injection, once a week, for five weeks"
917247|NCT01037244|B5|Baseline|Total|Total of all reporting groups
917248|NCT01037244|B4|Baseline|Placebo|Placebo tablets
917249|NCT01037244|B3|Baseline|Udenafil 150mg|Udenafil 150mg tablets
917250|NCT01037244|B2|Baseline|Udenafil 100 mg|Udenafil 100 mg tablets
917251|NCT01037244|B1|Baseline|Udenafil 50 mg|Udenafil 50 mg tablets
917252|NCT01037244|P4|Participant Flow|Placebo|Placebo tablets
917253|NCT01037244|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
917254|NCT01037244|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
917255|NCT01037244|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
917256|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917257|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917258|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917259|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917260|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917261|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917262|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917263|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917264|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917265|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917266|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917267|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917268|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917269|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917270|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917271|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917272|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917273|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917274|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917275|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917276|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917277|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917278|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917279|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917280|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917281|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917282|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917283|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917284|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917285|NCT01037244|O3|Outcome|Udenafil 150mg|Udenafil 150mg tablets
917286|NCT01037244|O2|Outcome|Udenafil 100 mg|Udenafil 100 mg tablets
917287|NCT01037244|O1|Outcome|Udenafil 50 mg|Udenafil 50 mg tablets
917288|NCT01037244|O4|Outcome|Placebo|Placebo tablets
917318|NCT01037218|P3|Participant Flow|Udenafil 150mg|Udenafil 150mg tablets
917319|NCT01037218|P2|Participant Flow|Udenafil 100 mg|Udenafil 100 mg tablets
917320|NCT01037218|P1|Participant Flow|Udenafil 50 mg|Udenafil 50 mg tablets
917321|NCT01037218|O4|Outcome|Placebo|Placebo tablets
917375|NCT01037218|E2|Reported Event|Udenafil 100 mg|Udenafil 100 mg tablets
917376|NCT01037218|E1|Reported Event|Udenafil 50 mg|Udenafil 50 mg tablets
917377|NCT01037192|B3|Baseline|Total|Total of all reporting groups
917378|NCT01037192|B2|Baseline|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
917379|NCT01037192|B1|Baseline|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
917380|NCT01037192|P2|Participant Flow|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
917381|NCT01037192|P1|Participant Flow|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
917382|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
917383|NCT01037192|O1|Outcome|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
917384|NCT01037192|O2|Outcome|Vancomycin Twice Daily|Vancomycin 15 mg/kg IV twice daily
917385|NCT01037192|O1|Outcome|Vancomycin Once Daily|Vancomycin 30 mg/kg IV daily
917386|NCT01037192|E2|Reported Event|Vancomycin Twice Daily|Subject receives vancomycin 15 mg/kg twice daily
917387|NCT01037192|E1|Reported Event|Vancomycin Once Daily|Subject receives vancomycin 30 mg/kg dose
917388|NCT01037127|B3|Baseline|Total|Total of all reporting groups
917389|NCT01037127|B2|Baseline|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917390|NCT01037127|B1|Baseline|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917391|NCT01037127|P2|Participant Flow|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917392|NCT01037127|P1|Participant Flow|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib (GSK1120212) 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917393|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917394|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917424|NCT01037114|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
922411|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
917395|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917396|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917397|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917480|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
917481|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
947788|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
917398|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917399|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917400|NCT01037127|O4|Outcome|Paticipants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917401|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917402|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917403|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis who were previously treated with standard therapy but not with BRAF inhibitors received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917404|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917405|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917661|NCT01035060|P1|Participant Flow|Older Adults|Persons aged ≥ 70 years
917406|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917407|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917408|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917482|NCT01036724|O2|Outcome|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
917483|NCT01036724|O1|Outcome|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
917484|NCT01036724|E2|Reported Event|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
947789|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
917409|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917410|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917411|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917412|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917425|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917458|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917459|NCT01036802|O2|Outcome|Placebo|Patients were on placebo
917662|NCT01035060|O2|Outcome|Young Adults|Age 18-35 years
917413|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917414|NCT01037127|O5|Outcome|Participants With BRAF Mutation V600K|Participants in this arm were those with a positive BRAF mutation at V600K, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917415|NCT01037127|O4|Outcome|Participants With BRAF Mutation V600E and no Prior Brain Mets|Participants in this arm were those with a positive BRAF mutation at V600E but no prior brain metastasis, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917416|NCT01037127|O3|Outcome|Participants With BRAF Mutation V600E|Participants in this arm were those with a positive BRAF mutation at V600E, who were previously treated with standard therapy but not with BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917417|NCT01037127|O2|Outcome|Participants Without Prior Brain Mets|Participants in this arm were those without prior brain metastasis, who were previoulsy treated with standard thearpy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917418|NCT01037127|O1|Outcome|Participants With Prior Brain Mets|Participants in this arm were those with prior (before the start of this study) brain metastasis, who were previously treated with standard therapy but not BRAF inhibitors. Participants received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met.
917419|NCT01037127|O2|Outcome|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917485|NCT01036724|E1|Reported Event|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
917486|NCT01036529|B3|Baseline|Total|Total of all reporting groups
917487|NCT01036529|B2|Baseline|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
947790|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
917420|NCT01037127|O1|Outcome|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917421|NCT01037127|E2|Reported Event|Trametinib 2 mg: Prior Standard Therapy|Participants who were previously treated with standard therapy, but not with BRAF inhibitors, received trametinib 2 mg tablets orally qd until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, 55 participants were enrolled in this cohort because objective responses occurred in 6 participants at the time of the interim analysis. Eligible participants who had been consented at the time the 55th participant was dosed were allowed to enroll. This led to the overenrollment of 2 participants (total of 57 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917422|NCT01037127|E1|Reported Event|Trametinib 2 mg: Prior BRAF Inhibitors|Participants who were previously treated (before the start of this study) with BRAF (v-Raf murine sarcoma viral oncogene homolog B1) inhibitors received trametinib 2 milligram (mg) tablets orally once daily (qd) until treatment discontinuation criteria were met. Per the pre-specified study design, enrollment could have been stopped if objective response was observed in fewer than 3 participants among the first 30 participants enrolled. Per this criterion, enrollment in this cohort was stopped because, after enrollment of the first 30 participants, no objective responses were observed. Eligible participants who had been consented at the time the 30th participant was dosed were allowed to enroll, leading to overenrollment of 10 participants (total of 40 participants in this cohort). An interim analysis was performed after 30 participants had completed the first target post-dose disease assessment at 8 weeks.
917423|NCT01037114|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917455|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
917456|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917457|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
917426|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917427|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917428|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917429|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917430|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917431|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917488|NCT01036529|B1|Baseline|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
917489|NCT01036529|P2|Participant Flow|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
917490|NCT01036529|P1|Participant Flow|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulator Intervention
917432|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917433|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917434|NCT01037114|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917435|NCT01037114|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the first long-term follow-up NCT00289718 and this long-term follow-up.~A challenge dose of the Havrix™ or Engerix™-B vaccines can be administered in this study based on serology results at each time point."
917436|NCT01037088|B1|Baseline|All Participants|All participants who were randomized
917437|NCT01037088|P1|Participant Flow|All Participants|All participants were randomized to a 3 way cross over design and received 3.53% THC, 1.29% THC and placebo cannabis.
917438|NCT01037088|O3|Outcome|Placebo Cannabis|trace THC by weight
917439|NCT01037088|O2|Outcome|Low Dose Cannabis|1.29% THC by weight
917440|NCT01037088|O1|Outcome|Mild Dose Cannabis|3.53% THC by weight
917441|NCT01037088|E3|Reported Event|Placebo Cannabis|0% 9-delta tetrahydrocannabinol by weight
917442|NCT01037088|E2|Reported Event|Low Dose Cannabis|1.29% 9-delta tetrahydrocannabinol by weight
917443|NCT01037088|E1|Reported Event|Mild Dose Cannabis|3.53% 9-delta tetrahydrocannabinol by weight
917444|NCT01036802|B3|Baseline|Total|Total of all reporting groups
917445|NCT01036802|B2|Baseline|Placebo|Patients were randomized to placebo
917446|NCT01036802|B1|Baseline|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917447|NCT01036802|P2|Participant Flow|Placebo|Patients were randomized to placebo
917448|NCT01036802|P1|Participant Flow|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917449|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
917450|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917451|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
917452|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917453|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
917454|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917460|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917461|NCT01036802|O2|Outcome|Placebo|Patients were randomized to placebo
917462|NCT01036802|O1|Outcome|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917463|NCT01036802|E2|Reported Event|Placebo|Patients were randomized to placebo
917464|NCT01036802|E1|Reported Event|Warfarin|Patients on the active treatment arm will be anticoagulated using the vitamin K antagonist, warfarin
917465|NCT01036763|B1|Baseline|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917466|NCT01036763|P1|Participant Flow|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917467|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917468|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917469|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917470|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917471|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917472|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917473|NCT01036763|O1|Outcome|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917474|NCT01036763|E1|Reported Event|Spiriva® 18 Microgram/Spiriva® Respimat®|1 capsule/2 puffs once daily at the same time
917475|NCT01036724|B3|Baseline|Total|Total of all reporting groups
917476|NCT01036724|B2|Baseline|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
917477|NCT01036724|B1|Baseline|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
917478|NCT01036724|P2|Participant Flow|NAVX|Those subjects whose cases use the NAVX(TM) EP Navigational System.
917479|NCT01036724|P1|Participant Flow|Carto 3|Those subjects whose cases use the CARTO 3 EP Navigation System.
947791|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
917491|NCT01036529|O2|Outcome|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
917492|NCT01036529|O1|Outcome|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
917493|NCT01036529|E2|Reported Event|Back Surgery|Discectomy, laminotomy, laminectomy, foraminotomy, fusion with or without instrumentation
917494|NCT01036529|E1|Reported Event|Precision Spinal Cord Stimulator|Precision Spinal Cord Stimulation System
917495|NCT01036490|B3|Baseline|Total|Total of all reporting groups
917496|NCT01036490|B2|Baseline|Control|Nutritional counseling alone
917497|NCT01036490|B1|Baseline|Exercise|12-week (3 days per week) program of aerobic and resistance training followed by 40 weeks of a home exercise program plus nutritional counseling
917498|NCT01036490|P2|Participant Flow|Control|Dietary management alone
917499|NCT01036490|P1|Participant Flow|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917500|NCT01036490|O2|Outcome|Control|Dietary management alone
917501|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917502|NCT01036490|O2|Outcome|Control|Dietary management alone
917503|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917504|NCT01036490|O2|Outcome|Control|Dietary management alone
917505|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917506|NCT01036490|O2|Outcome|Control|Dietary management alone
917507|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917508|NCT01036490|O2|Outcome|Control|Dietary management alone
917509|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917510|NCT01036490|O2|Outcome|Control|Dietary management alone
917511|NCT01036490|O1|Outcome|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917512|NCT01036490|E2|Reported Event|Control|Dietary management alone
917513|NCT01036490|E1|Reported Event|Exercise|Dietary management plus 12 weeks of combined aerobic and resistance exercise training followed by 40 weeks of supervised home exercise.
917514|NCT01036438|B3|Baseline|Total|Total of all reporting groups
917515|NCT01036438|B2|Baseline|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917516|NCT01036438|B1|Baseline|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917517|NCT01036438|P2|Participant Flow|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917518|NCT01036438|P1|Participant Flow|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917519|NCT01036438|O2|Outcome|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917520|NCT01036438|O1|Outcome|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917657|NCT01035060|B3|Baseline|Total|Total of all reporting groups
917521|NCT01036438|E2|Reported Event|Mepilex Ag|Mepilex Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917522|NCT01036438|E1|Reported Event|Mepilex Product|Mepilex without Ag: Mepilex is designed for a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers and traumatic wounds, e.g. skin tears and secondary healing wounds.
917523|NCT01036321|B3|Baseline|Total|Total of all reporting groups
917524|NCT01036321|B2|Baseline|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917525|NCT01036321|B1|Baseline|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917526|NCT01036321|P2|Participant Flow|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917527|NCT01036321|P1|Participant Flow|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917528|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917529|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917530|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917531|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917532|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917533|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917534|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917535|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917536|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917537|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917538|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917539|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917540|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917541|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917542|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917543|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917544|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917545|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917546|NCT01036321|O2|Outcome|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917547|NCT01036321|O1|Outcome|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917548|NCT01036321|E2|Reported Event|Placebo Comparator: Methyl Cellulose Blend|Placebo: Methyl cellulose blend - 2 capsules daily.
917549|NCT01036321|E1|Reported Event|Active Comparator: Purified Isoflavones|Soy-based isoflavone concentrate with methyl cellulose blend filler - 2 capsules daily.
917550|NCT01036165|B1|Baseline|Subject Disposition|Intent-to-Treat Analysis
917551|NCT01036165|P1|Participant Flow|Subject Disposition|Intent-to-Treat Analysis
917552|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
917553|NCT01036165|O1|Outcome|Subject Disposition|Intent-to-Treat Analysis
917554|NCT01036165|E1|Reported Event|Subject Disposition|Intent-to-Treat Analysis
917555|NCT01036009|B3|Baseline|Total|Total of all reporting groups
917556|NCT01036009|B2|Baseline|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917557|NCT01036009|B1|Baseline|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
917558|NCT01036009|P2|Participant Flow|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917559|NCT01036009|P1|Participant Flow|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
917560|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917561|NCT01036009|O1|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917562|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917563|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
917564|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917565|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
917566|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917751|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
917567|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
917568|NCT01036009|O2|Outcome|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917569|NCT01036009|O1|Outcome|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
917570|NCT01036009|E2|Reported Event|Group II: Intervention|"Group II (intervention): Patients undergo withdrawal of immunosuppression and receive donor lymphocyte infusions between days 60-365 post-transplant (or until full donor chimerism is achieved). Patients also undergo clinical monitoring and repeat chimerism testing as in group I.~Withdrawal of immunosuppression and donor lymphocyte infusion: Intervention will involve fast withdrawal of immunosuppression and DLI until full donor chimerism is achieved."
917571|NCT01036009|E1|Reported Event|Group I: Observation|Group I (observation): Patients with full donor chimerism and no evidence of MRD continue to undergo clinical monitoring for acute and chronic graft-vs-host disease and relapse until 3 years post-transplant. Patients undergo repeat chimerism testing at 12 and 24 months post-transplant.
917572|NCT01035944|B5|Baseline|Total|Total of all reporting groups
917573|NCT01035944|B4|Baseline|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917574|NCT01035944|B3|Baseline|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
917575|NCT01035944|B2|Baseline|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917576|NCT01035944|B1|Baseline|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
917577|NCT01035944|P4|Participant Flow|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917578|NCT01035944|P3|Participant Flow|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
917579|NCT01035944|P2|Participant Flow|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917580|NCT01035944|P1|Participant Flow|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
917581|NCT01035944|O4|Outcome|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917582|NCT01035944|O3|Outcome|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
947792|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
917583|NCT01035944|O2|Outcome|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917584|NCT01035944|O1|Outcome|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
917585|NCT01035944|E4|Reported Event|Control Bedside.|"The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917586|NCT01035944|E3|Reported Event|HemCon Bedside|"The intervention for the HemCon Beside arm is the HemCon Dressing. The other sub-study will evaluate the use of HemCon dressings compared to control dressings in bedside debridement. In this sub-study, 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
917587|NCT01035944|E2|Reported Event|Control Operating Room|"The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~Gauze and saline dressings.: Control for both settings will be gauze and saline dressings."
917588|NCT01035944|E1|Reported Event|HemCon Operating Room|"The HemCon dressing is the intervention for the HemCon Operating Room arm. The first sub-study will evaluate the use of HemCon dressings in the operating room setting. 20 patients will be treated with HemCon dressings following a debridement, and 20 patients will be treated with gauze dressings following a debridement.~HemCon Dressings and HemCon ChitoGauze; chitosan-based.: Perform debridement of chronic wounds using HemCon chitosan-based dressings and HemCon ChitoGauze both at bedside and in the Operating Room (OR) settings. Control for both settings will be gauze and saline dressings."
917589|NCT01035905|B3|Baseline|Total|Total of all reporting groups
917590|NCT01035905|B2|Baseline|Narafilcon A|Narafilcon A contact lens
917591|NCT01035905|B1|Baseline|Nelfilcon A|Nelfilcon A contact lens
917592|NCT01035905|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
917593|NCT01035905|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
917594|NCT01035905|O2|Outcome|Narafilcon A|Narafilcon A contact lens
917595|NCT01035905|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
917596|NCT01035905|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
917597|NCT01035905|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
917598|NCT01035138|B4|Baseline|Total|Total of all reporting groups
917599|NCT01035138|B3|Baseline|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917600|NCT01035138|B2|Baseline|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917658|NCT01035060|B2|Baseline|Young Adults|
917659|NCT01035060|B1|Baseline|Older Adults|
917601|NCT01035138|B1|Baseline|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917602|NCT01035138|P3|Participant Flow|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
917603|NCT01035138|P2|Participant Flow|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 (LY 100 mg) orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during this extension study (LFBF)
917604|NCT01035138|P1|Participant Flow|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 milligram (mg) orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917605|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917606|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917607|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917608|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917609|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917610|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917611|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917612|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917613|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917614|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917615|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917616|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917617|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917618|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917619|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917620|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917621|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917622|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917623|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917624|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917625|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917626|NCT01035138|O1|Outcome|LY 140 mg|Participants received 140 mg LY450319 orally once daily up to 24 months during extension study (LFBF)
917627|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917628|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917660|NCT01035060|P2|Participant Flow|Young Adults|Persons aged 18-30 years
917629|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917630|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917631|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917632|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917633|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917634|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917635|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during Study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917636|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917637|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917638|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917639|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917640|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917641|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917642|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917643|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917644|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917645|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917646|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917647|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917648|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917649|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917650|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917651|NCT01035138|O3|Outcome|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917652|NCT01035138|O2|Outcome|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917653|NCT01035138|O1|Outcome|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917654|NCT01035138|E3|Reported Event|LFAN LY 140 mg/LY 140 mg|Participants received 140 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917655|NCT01035138|E2|Reported Event|LFAN LY 100 mg/ LY 140 mg|Participants received 100 mg LY450319 orally once daily during study LFAN, and 140 mg LY450319 orally once daily up to 24 months during extension study
917656|NCT01035138|E1|Reported Event|LFAN Placebo/LY140 mg|Participants received placebo orally once daily for 76 weeks during study LFAN. At the end of 76 weeks, participants received LY450319 titrated up to 140 mg orally once daily. Participants continued 140 mg LY450319 (LY 140 mg) orally once daily up to 24 months during this extension study (LFBF)
917667|NCT01035047|B2|Baseline|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917668|NCT01035047|B1|Baseline|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917669|NCT01035047|P2|Participant Flow|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917670|NCT01035047|P1|Participant Flow|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917671|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917672|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917673|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917752|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
947793|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
917674|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917675|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917676|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917677|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917678|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917679|NCT01035047|O2|Outcome|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917680|NCT01035047|O1|Outcome|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917681|NCT01035047|E2|Reported Event|Inpatient Care|This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
917682|NCT01035047|E1|Reported Event|CDU-CMR Protocol|"Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.~Clinical decision unit care, coupled with cardiac MRI : After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician."
917683|NCT01034709|B3|Baseline|Total|Total of all reporting groups
917684|NCT01034709|B2|Baseline|Asymptomatic|Subjects who are serologically negative for CMV IgG
917685|NCT01034709|B1|Baseline|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
917686|NCT01034709|P2|Participant Flow|Asymptomatic|Subjects who are serologically negative for CMV IgG prior to transplantation and do not have any CMV symptoms
917687|NCT01034709|P1|Participant Flow|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
917688|NCT01034709|O2|Outcome|Asymptomatic|Subjects who are serologically negative for CMV IgG
917689|NCT01034709|O1|Outcome|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
917690|NCT01034709|E2|Reported Event|Asymptomatic|Subjects who are serologically negative for CMV IgG
917691|NCT01034709|E1|Reported Event|Symptomatic|Subjects with a confirmed CMV viremia by the site's CMV-LDT
917692|NCT01034657|B1|Baseline|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917693|NCT01034657|P3|Participant Flow|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
918486|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
917694|NCT01034657|P2|Participant Flow|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917695|NCT01034657|P1|Participant Flow|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917696|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917697|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917698|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917699|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917700|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917753|NCT01034631|E3|Reported Event|Phase II: Arm B Participants|Phase II: Arm B Participants
917754|NCT01034631|E2|Reported Event|Phase II: Arm A|Phase II Participants, Arm A
917755|NCT01034631|E1|Reported Event|Phase I Participants|Participants in the phase I dose escalation portion of the study.
917701|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917702|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917703|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917704|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917705|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917706|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917707|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917708|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917709|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917710|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917711|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917712|NCT01034657|O3|Outcome|Not Randomized|
917713|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917714|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917715|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917716|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917717|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917718|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917719|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917720|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917721|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917722|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917756|NCT01034592|B1|Baseline|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
947794|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
917723|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917724|NCT01034657|O3|Outcome|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917725|NCT01034657|O2|Outcome|LBH589 + Epoetin Alfa|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917726|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917727|NCT01034657|O1|Outcome|LBH589|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917728|NCT01034657|E4|Reported Event|Not Randomized|Participant, who was eligible for randomization, was not randomized. The participant had stable disease and should have been randomized, but in error, was considered a responder and therefore continued on single agent LBH589.
917729|NCT01034657|E3|Reported Event|LBH589 + ESA - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917730|NCT01034657|E2|Reported Event|LBH589 - Randomized Phase|During the randomized phase, participants randomized to LBH589 + Epoetin Alfa (ESA) received oral LBH589 40mg/30mg + ESA 30000 international units (IU)/week injected subcutaneously for 4 months.
917731|NCT01034657|E1|Reported Event|LBH589 - Core Phase|During the core phase, all participants received oral LBH589 40 mg (30 mg after a protocol amendment) for 4 months. During the randomization phase, participants with hematological improvement of the erythropoetic system (HI-E) and participants with stable disease, who were randomized to single agent LBH589, continued on single agent LBH589 40mg/30mg for an additional 4 months.
917732|NCT01034631|B4|Baseline|Total|Total of all reporting groups
917733|NCT01034631|B3|Baseline|Phase II: Arm B Participants|"Phase II: Arm B Participants~Everolimus only, followed by BNC105P monotherapy"
917734|NCT01034631|B2|Baseline|Phase II: Arm A|"Phase II Participants, Arm A~Everolimus + BNC105P"
917735|NCT01034631|B1|Baseline|Phase I Participants|Participants in the phase I dose escalation portion of the study.
917736|NCT01034631|P3|Participant Flow|Phase II: Arm B Participants|"Phase II: Arm B Participants~Everolimus 10mg followed by BNC105P monotherapy (16mg/m^2) following progression or intolerable toxicity on Everolimus therapy."
917737|NCT01034631|P2|Participant Flow|Phase II: Arm A|"Phase II Participants, Arm A~Everolimus 10mg + BNC105P(Phase I MTD)"
917738|NCT01034631|P1|Participant Flow|Phase I Participants|Participants in the phase I dose escalation portion of the study.
917739|NCT01034631|O1|Outcome|Phase II Participants With Sufficient Correlative Samples|A subset of Phase II Participants who had sufficient correlative samples drawn for plasma biomarker analysis.
917740|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917833|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917741|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917742|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917743|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917744|NCT01034631|O1|Outcome|Arm B Participants Who Crossed Over to BNC105P Monotherapy|After progression on everolimus, 33 participants crossed over to BNC105P monotherapy per protocol.
917745|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917746|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917747|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
917748|NCT01034631|O1|Outcome|Phase I Participants|15 total Participants were recruited to the phase I portion of the study.
917749|NCT01034631|O2|Outcome|Sequential Arm B:Everolimus Followed by BNC105P Monotherapy|"Sequential Arm B: Everolimus 10 mg, 21 day cycle~Patients to receive BNC105P monotherapy at 16 mg/m2 following progression or intolerable toxicity on everolimus therapy.~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917750|NCT01034631|O1|Outcome|Combination Arm A: Everolimus + BNC105P|"Combination Arm A: Everolimus 10 mg, BNC105P MTD (from Phase 1 study) 21 day cycle~Everolimus: Everolimus 10 mg. Taken orally, every evening, 1 hr before or 2 hrs after meals~BNC105P: BNC105P, up to 16 mg/m^2"
917757|NCT01034592|P1|Participant Flow|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
917758|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
917759|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
917760|NCT01034592|O1|Outcome|Lenalidomide|"Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.~Lenalidomide: 2.5 mg/wk up to 5 mg 3x/wk"
917761|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
917762|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
917763|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
917764|NCT01034592|O1|Outcome|Lenalidomide|Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
917765|NCT01034592|E1|Reported Event|Serious Adverse Events|Serious Adverse Events include: adverse events that result in death, require either inpatient hospitalization or the prolongation of hospitalization, are life-threatening, result in a persistent or significant disability/incapacity or result in a congenital anomaly/birth defect. Other important medical events, based upon appropriate medical judgment, may also be considered Serious Adverse Events if a trial participant's health is at risk and intervention is required to prevent an outcome mentioned.
917766|NCT01034579|B3|Baseline|Total|Total of all reporting groups
917767|NCT01034579|B2|Baseline|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917768|NCT01034579|B1|Baseline|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917769|NCT01034579|P2|Participant Flow|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917770|NCT01034579|P1|Participant Flow|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917771|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917772|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917798|NCT01034553|O3|Outcome|Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917773|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917774|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917775|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917776|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917777|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917778|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917779|NCT01034579|O2|Outcome|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917780|NCT01034579|O1|Outcome|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917997|NCT01034176|O1|Outcome|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
917781|NCT01034579|E2|Reported Event|Copaxone® Cohort|Participants who had received Copaxone® (Glatiramer Acetate) 20 milligram once daily for 96 weeks in study 24735 (NCT00078338) and not participated in the initial PGx sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917782|NCT01034579|E1|Reported Event|Rebif® Cohort|Participants who had received Rebif® 44 microgram (mcg) three times a week for 96 weeks in study 24735 (NCT00078338) and not participated in the initial pharmacogenetics (PGx) sub-study were enrolled in this retrospective cohort study wherein single blood sampling was performed for pharmacogenetic markers analysis.
917783|NCT01034553|B1|Baseline|All Patients|"All Patients that received oral aurora A kinase inhibitor MLN8237 and bortezomib IV are summarized in this section.~Aurora A kinase inhibitor MLN8237: Given orally"
917784|NCT01034553|P6|Participant Flow|Phase II, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917785|NCT01034553|P5|Participant Flow|Phase I, Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
917786|NCT01034553|P4|Participant Flow|Phase I, Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
917787|NCT01034553|P3|Participant Flow|Phase I, Dose 1|"Patients receive 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
917788|NCT01034553|P2|Participant Flow|Phase I, Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
917789|NCT01034553|P1|Participant Flow|Phase I, Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~Aurora A kinase inhibitor MLN8237: Given orally bortezomib: Given IV"
917790|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 and bortezomib IV. >~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917791|NCT01034553|O1|Outcome|All Patients|"Patients receive oral aurora A kinase inhibitor MLN8237 once daily on days 1-14 and bortezomib IV on days 1, 4, 8 and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917792|NCT01034553|O4|Outcome|Dose Level 3|Patients received 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
917793|NCT01034553|O3|Outcome|Dose Level 2|Patients received 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
917794|NCT01034553|O2|Outcome|Dose Level 1|Patients received 30mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
917795|NCT01034553|O1|Outcome|Dose Level 0|This includes patients who received 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11. As well as, patients who received 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.
917796|NCT01034553|O5|Outcome|Dose 3|"Patients receive 50mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917797|NCT01034553|O4|Outcome|Dose 2|"Patients receive 40mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917799|NCT01034553|O2|Outcome|Dose 0|"Patients receive 20mg aurora A kinase inhibitor MLN8237 twice daily on days 1-7 and 1.5mg Bortezomib on days 1, 8,15, and 22.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917800|NCT01034553|O1|Outcome|Dose 0**|"Patients receive 25mg aurora A kinase inhibitor MLN8237 once daily on days 1-14 and 1.3mg Bortezomib on days 1, 4,8, and 11.~>~> Aurora A kinase inhibitor MLN8237: Given orally~>~> bortezomib: Given IV"
917801|NCT01034553|E1|Reported Event|All Patients|bortezomib: Given IV
917802|NCT01034540|B3|Baseline|Total|Total of all reporting groups
917803|NCT01034540|B2|Baseline|Placebo/Prescription Omega-3 Acid Ethyl Esters (POM3)|Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
917804|NCT01034540|B1|Baseline|Prescription Omega-3 Acid Ethyl Esters (POM3)/Placebo|POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
917805|NCT01034540|P2|Participant Flow|Placebo/Prescription Omega-3 Acid Ethyl Esters|Placebo (corn oil 4 g/d) for the first six weeks of treatment. Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the second six weeks of treatment
917806|NCT01034540|P1|Participant Flow|Prescription Omega-3 Acid Ethyl Esters/Placebo|Prescription omega-3 acid ethyl esters (POM3; Lovaza 4 g/d) for the first six weeks of treatment. Placebo (corn oil 4 g/d) for the second six weeks of treatment
917807|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
917808|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Treatment period I was the average of values at weeks 4 and 6; treatment period II was the average of values at weeks 12 and 14.
917809|NCT01034540|O2|Outcome|Prescription Omega-3 Acid Ethyl Esters|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
917844|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917810|NCT01034540|O1|Outcome|Control|Data from the two treatment sequences (Control/Prescription omega-3-acid ethyl esters and Prescription omega-3-acid ethyl esters/Control) were pooled. Data for treatment intervention period I were collected at week 6; data for treatment intervention period II were collected at week 14.
917811|NCT01034540|E2|Reported Event|Placebo|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
917812|NCT01034540|E1|Reported Event|POM3|Data from the 2 treatment sequences (POM3/control and control/POM3) were pooled.
917813|NCT01034462|B3|Baseline|Total|Total of all reporting groups
917814|NCT01034462|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
917815|NCT01034462|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
917816|NCT01034462|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
917817|NCT01034462|P1|Participant Flow|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
917818|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
917819|NCT01034462|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
917820|NCT01034462|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks
917821|NCT01034462|O1|Outcome|Placebo|"Matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo to be given orally, in capsule form, once daily, for 8 weeks."
917822|NCT01034462|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
917823|NCT01034462|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
917824|NCT01034397|B3|Baseline|Total|Total of all reporting groups
917825|NCT01034397|B2|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks.
917826|NCT01034397|B1|Baseline|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
917827|NCT01034397|P2|Participant Flow|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of greater than or equal to [≥]20 percent [%] in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks through Week 24.
917828|NCT01034397|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) intravenously (IV) once every 4 weeks for 24 weeks.
917829|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917830|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917831|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917832|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917834|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917835|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917836|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917837|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917838|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917839|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917840|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917841|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917842|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917843|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
919571|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
917845|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917846|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917847|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917848|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917849|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Patient's Global Assessment of Pain was assessed using a 10-mm horizontal VAS (0 to 10 mm) where 0=pain absent and 10=intolerable pain. Participants responded by placing a mark on the line to indicate their current level of pain; the distance from the left edge to the mark was recorded. Change in Patient Global Assessment of Pain was determined as the difference in the scores at baseline and Week 12. A negative number indicated improvement.
917850|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917851|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917852|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917853|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917854|NCT01034397|O3|Outcome|Placebo-Tocilizumab|At 12 Weeks participants who did not show an improvement of ≥20% in tender and swollen joint counts were offered a rescue therapy with open-label tocilizumab 8mg/kg every 4 weeks
917855|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 24 weeks. At 12 weeks, participants who did not respond to treatment (those who did not show improvement of at least 20% in tender joint count and swollen joint count) were offered rescue therapy with open-label tocilizumab 8 mg/kg every 4 weeks.
917856|NCT01034397|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 24 weeks
917857|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917858|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917859|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917860|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917861|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
918487|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
917862|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917863|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917864|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917865|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917866|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917867|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917868|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917869|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917870|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917871|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917957|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917872|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917873|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917874|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917875|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917876|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917877|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917878|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917879|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917880|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917881|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917882|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917883|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917884|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917885|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917886|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917887|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917888|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917889|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
918961|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
917890|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917891|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917892|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917893|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917894|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917895|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917896|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917897|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917898|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917899|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917900|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
918523|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
917901|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917902|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917903|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for a 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917904|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917905|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917906|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917907|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917908|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917909|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917910|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917911|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917912|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917913|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917914|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917915|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917916|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917917|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917918|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917919|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917920|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917921|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917922|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917923|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917924|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917925|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917926|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917927|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917928|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917958|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917929|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917930|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917931|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917932|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917933|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917934|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917935|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917936|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917937|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917938|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917939|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917940|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917941|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917942|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917943|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917944|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917945|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
918436|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
917946|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917947|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917948|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917949|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917950|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917951|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917952|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917953|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917954|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917955|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917956|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
947795|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
917959|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917960|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917961|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917962|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917963|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917964|NCT01034397|O3|Outcome|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917965|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
917966|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917967|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917968|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917969|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917970|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917971|NCT01034397|O2|Outcome|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in tender joint count [TJC] and swollen joint count [SJC]) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917972|NCT01034397|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917973|NCT01034397|E3|Reported Event|Placebo-Tocilizumab 8 mg/kg|Participants received placebo IV once every 4 weeks for 12 weeks (total of 3 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) received tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
918017|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
917974|NCT01034397|E2|Reported Event|Placebo|Participants received placebo IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions). At 12 weeks, participants who did not respond to treatment (those who did not show improvement of ≥20% in TJC and SJC) were offered rescue therapy with open-label tocilizumab 8 mg/kg IV once every 4 weeks through Week 20.
917975|NCT01034397|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (minimum dose of 480 mg, maximum dose of 800 mg) IV once every 4 weeks for 20 weeks (total of 6 infusions).
917976|NCT01034358|B1|Baseline|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
917977|NCT01034358|P1|Participant Flow|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
917978|NCT01034358|O1|Outcome|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
917979|NCT01034358|E1|Reported Event|Human Papillomavirus Vaccine|The Gardasil HPV vaccine was administered in 3 doses: baseline, 2 months, and 6 months.
917980|NCT01034306|B3|Baseline|Total|Total of all reporting groups
917981|NCT01034306|B2|Baseline|Placebo|MAtching placebo q12 for 12 weeks
917982|NCT01034306|B1|Baseline|CF101 1mg|CF101 1mg q12 for 12 weeks
917983|NCT01034306|P2|Participant Flow|Placebo|Matching placebo q12 for 12 weeks
917984|NCT01034306|P1|Participant Flow|CF101 1mg|CF101 1mg q12 for 12 weeks
917985|NCT01034306|O2|Outcome|Placebo|Matching placebo q12 for 12 weeks
917986|NCT01034306|O1|Outcome|CF101 1mg|CF101 1mg q12 for 12 weeks
917987|NCT01034306|E2|Reported Event|Placebo|Matching placebo q12 for 12 weeks
917988|NCT01034306|E1|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
917989|NCT01034176|B3|Baseline|Total|Total of all reporting groups
917990|NCT01034176|B2|Baseline|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
917991|NCT01034176|B1|Baseline|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
917992|NCT01034176|P2|Participant Flow|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
917993|NCT01034176|P1|Participant Flow|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
917994|NCT01034176|O2|Outcome|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
917995|NCT01034176|O1|Outcome|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
917996|NCT01034176|O2|Outcome|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
917998|NCT01034176|E2|Reported Event|Placebo|"placebo identical to levofloxacin drug daily for 30 days~placebo: no dose, tablet, daily, 30 days"
917999|NCT01034176|E1|Reported Event|Levofloxacin|"Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days~levofloxacin: 500 mg tablet, daily, 30 days"
918000|NCT01034163|B3|Baseline|Total|Total of all reporting groups
918001|NCT01034163|B2|Baseline|Placebo|Participants received matching placebo to PAN TIW, QOW.
918002|NCT01034163|B1|Baseline|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
918003|NCT01034163|P2|Participant Flow|Placebo|Participants received matching placebo to PAN TIW, QOW.
918004|NCT01034163|P1|Participant Flow|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
918005|NCT01034163|O2|Outcome|Placebo|Participants received matching placebo to PAN TIW, QOW.
918006|NCT01034163|O1|Outcome|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
918007|NCT01034163|E2|Reported Event|Placebo|Participants received matching placebo to PAN TIW, QOW.
918008|NCT01034163|E1|Reported Event|Panobinostat (PAN)|Participants received 45 mg orally 3 times a week (TIW), every other week (QOW).
918009|NCT01034137|B4|Baseline|Total|Total of all reporting groups
918010|NCT01034137|B3|Baseline|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918011|NCT01034137|B2|Baseline|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918012|NCT01034137|B1|Baseline|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918013|NCT01034137|P3|Participant Flow|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918014|NCT01034137|P2|Participant Flow|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918015|NCT01034137|P1|Participant Flow|Tocilizumab + Methotrexate|Participants received intravenous (IV) Tocilizumab (TCZ) 8 milligram (mg)/kilogram (kg) every four weeks for a maximum of 26 infusions + oral capsules of Methotrexate (MTX) 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918016|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918437|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918018|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918019|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918020|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918021|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918022|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918023|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918024|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918025|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918026|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918071|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918027|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918028|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918029|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918030|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918031|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918032|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918033|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918034|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918035|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918036|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918037|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918038|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918128|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918039|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918040|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918041|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918042|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918043|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918044|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918045|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918046|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918047|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918048|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918524|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918525|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918049|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918050|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918051|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918052|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918053|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918054|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918055|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918056|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918057|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918058|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918059|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918060|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918061|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918062|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918063|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918064|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918065|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918066|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918067|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918068|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918069|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918070|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918526|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918527|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918072|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918073|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918074|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918075|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918076|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918077|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918078|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918079|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918080|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918081|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918082|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918083|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918084|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918085|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918086|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918087|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918088|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918089|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918090|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918091|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918092|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918093|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918528|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918529|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918094|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918095|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918096|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918097|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918098|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918099|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918100|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918101|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918102|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918103|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918104|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918105|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918106|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918107|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918108|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918109|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918110|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918111|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918112|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918113|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918114|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918115|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918530|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918531|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918116|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918117|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918118|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918119|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918120|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918121|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918122|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918123|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918124|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918125|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918126|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918127|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week
918129|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918130|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918131|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918132|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918133|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918134|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918135|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918136|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918137|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918532|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918533|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918138|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918139|NCT01034137|O3|Outcome|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918140|NCT01034137|O2|Outcome|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918141|NCT01034137|O1|Outcome|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918142|NCT01034137|E3|Reported Event|Methotrexate + Placebo Tocilizumab|Participants received weekly oral MTX in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week + matching placebo TCZ IV 8 mg/kg every four week for a maximum of 26 infusions. The weekly dose of MTX was taken on one particular day of the week.
918143|NCT01034137|E2|Reported Event|Tocilizumab + Placebo Methotrexate|Participants received IV TCZ 8 mg/kg every four weeks for a maximum of 26 infusions + weekly oral matching placebo MTX capsules in climbing dosages. The weekly dose of placebo MTX was taken on one particular day of the week.
918144|NCT01034137|E1|Reported Event|Tocilizumab + Methotrexate|Participants received IV TCZ 8 mg/ kg every four weeks for a maximum of 26 infusions + oral capsules of MTX 10–30 mg/week in climbing dosages of 5 mg starting at 10 mg up till a maximum dosage of 30 mg/week. The weekly dose of MTX was taken on one particular day of the week.
918145|NCT01034111|B1|Baseline|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
918146|NCT01034111|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
918147|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
918148|NCT01034111|O1|Outcome|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
918149|NCT01034111|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg tablet daily for 4 weeks as add-on therapy to a stable dose of metformin
918150|NCT01033942|B4|Baseline|Total|Total of all reporting groups
918151|NCT01033942|B3|Baseline|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918152|NCT01033942|B2|Baseline|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918296|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918153|NCT01033942|B1|Baseline|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918154|NCT01033942|P3|Participant Flow|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918155|NCT01033942|P2|Participant Flow|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918156|NCT01033942|P1|Participant Flow|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918157|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918158|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918159|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918160|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918161|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918162|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918163|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918164|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918165|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918166|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918167|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918168|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918169|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918170|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918431|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918432|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918171|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918172|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918173|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918174|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and Tenofovir (TDf) Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918175|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918176|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918177|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918178|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918179|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918308|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918180|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918181|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918182|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918183|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918184|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918185|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918186|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918187|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918188|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918189|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918190|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918191|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918192|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918193|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918194|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918195|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918196|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918197|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918385|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918198|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918199|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918200|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918201|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918202|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918203|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918204|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918205|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918206|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918207|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918208|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918209|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918210|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918211|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918212|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918213|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918214|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918215|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918456|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
918457|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
918458|NCT01033851|O2|Outcome|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
918216|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918217|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918218|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918219|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918220|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918221|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918222|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918223|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918224|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918225|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918226|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918227|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918228|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918229|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918230|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918231|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918232|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918233|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918459|NCT01033851|O1|Outcome|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
918460|NCT01033851|E2|Reported Event|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
918461|NCT01033851|E1|Reported Event|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
918234|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918235|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918236|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918237|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918238|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918239|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918240|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918241|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918242|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918243|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918244|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918245|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918246|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918247|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918248|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918249|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918250|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918251|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918462|NCT01033825|B8|Baseline|Total|Total of all reporting groups
918534|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918535|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
947796|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
918252|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918253|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918254|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918255|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918256|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918257|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918258|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918259|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918260|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918261|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918262|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918263|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918264|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918265|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918266|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918267|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918268|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918269|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918508|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918509|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918510|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918270|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918271|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918272|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918273|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918274|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918275|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918276|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918277|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918278|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918279|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918280|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918281|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918282|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918283|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918284|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918285|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918286|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918287|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
947797|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
918288|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918289|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918290|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918291|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918292|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918293|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918294|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918295|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918433|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918297|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918298|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918299|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918300|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918301|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918302|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918303|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918304|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918305|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918306|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918307|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
947798|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
918309|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918310|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918311|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918312|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918313|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918314|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918315|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918316|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918317|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918318|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918319|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918320|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918321|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918322|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918323|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918324|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918325|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918326|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918327|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918328|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918329|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918511|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918512|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918595|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918330|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918331|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918332|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918333|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918334|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918335|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918336|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918337|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918338|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918339|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918340|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918341|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918342|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918343|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918344|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918345|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918346|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918347|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918348|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918349|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918350|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918513|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918514|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918515|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918351|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918352|NCT01033942|O3|Outcome|No Pill Control|Subjects receive HIV behavioral intervention but no pill.
918353|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918354|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918355|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918356|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918357|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918358|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918434|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918484|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918359|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918360|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918361|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918362|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918363|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918364|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918365|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918366|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918367|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918516|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918368|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918369|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918370|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918371|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918372|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918373|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918374|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918485|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918375|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918376|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918377|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918378|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918379|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918380|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918381|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918382|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918383|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918384|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918517|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918386|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918387|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918388|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918389|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918390|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918391|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918392|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918393|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
923426|NCT01019928|B1|Baseline|AZD1386 95 mg|
918394|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918395|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918396|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918397|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918398|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918399|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918400|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918401|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918402|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918403|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918518|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918519|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918520|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918404|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918405|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918406|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918407|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918408|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918409|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918410|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918435|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918411|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918412|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918413|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918414|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918415|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918416|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918417|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918418|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918419|NCT01033942|O3|Outcome|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918420|NCT01033942|O2|Outcome|Placebo Pill Control|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918521|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918522|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
919720|NCT01031004|E2|Reported Event|Etafilcon A|contact lens worn as single use, daily wear
918421|NCT01033942|O1|Outcome|FTC/TDF as PrEP|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918422|NCT01033942|E3|Reported Event|No Pill Control|"Subjects receive HIV behavioral intervention but no pill.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918423|NCT01033942|E2|Reported Event|Placebo|"Blinded administration of placebo pill; HIV behavioral intervention~Placebo: Subjects receive placebo and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918424|NCT01033942|E1|Reported Event|FTC/TDC|"Blinded treatment with FTC (Emtricitabine) and TDf (Tenofovir)Pre-Exposure Prophylaxis (PrEP); HIV behavioral intervention~Coformulated emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) as PrEP: Subjects receive PrEP and receive clinical follow-up visits every four weeks for 24 weeks.~Many Men, Many Voices (3MV): Behavioral HIV-prevention intervention. Behavioral and biomedical data will be collected at baseline and every 4 weeks thereafter for 24 weeks."
918425|NCT01033864|B3|Baseline|Total|Total of all reporting groups
918426|NCT01033864|B2|Baseline|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918427|NCT01033864|B1|Baseline|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918428|NCT01033864|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918429|NCT01033864|P1|Participant Flow|Mycophenolate Mofetil (MMF)/Prednisone|Participants were administered MMF tablets or capsules, orally (PO), at a dose prescribed by their physician and prednisone up to 5 milligrams (mg) PO on Day 1.
918430|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
920323|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
918438|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918439|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918440|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918441|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918442|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918443|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918444|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918445|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918446|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918447|NCT01033864|O2|Outcome|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918448|NCT01033864|O1|Outcome|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918449|NCT01033864|E2|Reported Event|EC-MPS/Prednisone|Participants were administered EC-MPS tablets, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918450|NCT01033864|E1|Reported Event|MMF/Prednisone|Participants were administered MMF tablets or capsules, PO, at a dose prescribed by their physician and prednisone up to 5 mg PO on Day 1.
918451|NCT01033851|B3|Baseline|Total|Total of all reporting groups
918452|NCT01033851|B2|Baseline|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
918453|NCT01033851|B1|Baseline|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
918454|NCT01033851|P2|Participant Flow|Stress Management Education|Weekly 2 hour class, given for 8 weeks total.
918455|NCT01033851|P1|Participant Flow|Mindfulness Based Stress Reduction|Weekly 2 hour class, given for 8 weeks total.
918463|NCT01033825|B7|Baseline|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
918464|NCT01033825|B6|Baseline|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
918465|NCT01033825|B5|Baseline|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918466|NCT01033825|B4|Baseline|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918467|NCT01033825|B3|Baseline|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918468|NCT01033825|B2|Baseline|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918469|NCT01033825|B1|Baseline|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918470|NCT01033825|P7|Participant Flow|Placebo AQ Plus Dexamethasone 6 mg|Placebo AQ plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of these placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
918471|NCT01033825|P6|Participant Flow|Placebo HFA Plus Dexamethasone 6 mg|Placebo HFA plus Dexamethasone 6 mg once daily. Placebo is the study control & used for the study outcome analyses (CIC placebo/DEX placebo) for each delivery method (HFA or AQ). The positive control was used in a subset of the placebo subjects (18 subjects) during the last 4 days of Week 6. The active control was utilized to validate the assay sensitivity of the study, therefore this subset of placebo subjects was not included in the study outcome analyses.
918472|NCT01033825|P5|Participant Flow|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918473|NCT01033825|P4|Participant Flow|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918474|NCT01033825|P3|Participant Flow|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918475|NCT01033825|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918476|NCT01033825|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918477|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918478|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918479|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918480|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918481|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918482|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918483|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918488|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918489|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918490|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918491|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918492|NCT01033825|O3|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918493|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918494|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918495|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918496|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918497|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918498|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918499|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918500|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918501|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918502|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918503|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918504|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918505|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918506|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918507|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
919721|NCT01031004|E1|Reported Event|Narafilcon B|single use, daily wear contact lens
918536|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918537|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918538|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918539|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918540|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
918541|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
918542|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918543|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918544|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
918545|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918546|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918547|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918548|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918549|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918550|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918551|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918552|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918553|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918554|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918555|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918556|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918557|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918558|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918559|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918560|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918561|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918562|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918563|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918564|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918565|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918566|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918567|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918568|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918569|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918570|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918571|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918572|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918573|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918574|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918575|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918576|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918577|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918578|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918579|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918580|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918581|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918582|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918583|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918584|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918585|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918586|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918587|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918588|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918589|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918590|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918591|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918592|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918593|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918594|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918596|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918597|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918598|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918599|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918600|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918601|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918602|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918603|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918604|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918605|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918606|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918607|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918608|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918609|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918610|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918611|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918612|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918613|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918614|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918615|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918616|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918617|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918618|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918619|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918620|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918621|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918622|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918623|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918624|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918625|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918626|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918627|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918628|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918629|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918630|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918631|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918632|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918633|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918634|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918635|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918636|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918637|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918638|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918639|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918640|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
918641|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
918642|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918643|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918644|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918645|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918646|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918647|NCT01033825|O7|Outcome|Placebo AQ Plus 6 mg Dexamethasone|Placebo AQ plus 6 mg Dexamethasone once daily
918648|NCT01033825|O6|Outcome|Placebo HFA Plus 6 mg Dexamethasone|Placebo HFA plus 6 mg Dexamethasone once daily
918649|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918650|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918651|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918652|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918653|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918654|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918655|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918656|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918657|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918658|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918659|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918660|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918661|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918662|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918663|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918664|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918665|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918666|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918667|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918668|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918669|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918670|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918671|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918672|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918673|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918674|NCT01033825|O5|Outcome|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918675|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918676|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918677|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918678|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918679|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
918680|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918681|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918682|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918683|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918684|NCT01033825|O5|Outcome|Placebo Aqueous Nasal Spray|AQ Nasal Spray Placebo once daily
918685|NCT01033825|O4|Outcome|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous (AQ) Nasal Spray 200 mcg once daily
918686|NCT01033825|O3|Outcome|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918687|NCT01033825|O2|Outcome|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918688|NCT01033825|O1|Outcome|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide hydrofluoroalkane (HFA) Nasal Aerosol 320 mcg once daily
918689|NCT01033825|E5|Reported Event|AQ Nasal Spray Placebo|AQ Nasal Spray Placebo once daily
918690|NCT01033825|E4|Reported Event|Ciclesonide Aqueous Nasal Spray 200 Mcg|Ciclesonide Aqueous Nasal Spray 200 mcg once daily
918691|NCT01033825|E3|Reported Event|HFA Nasal Aerosol Placebo|HFA Nasal Aerosol Placebo once daily
918692|NCT01033825|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 160 Mcg|Ciclesonide HFA Nasal Aerosol 160 mcg once daily
918693|NCT01033825|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 320 Mcg|Ciclesonide HFA Nasal Aerosol 320 mcg once daily
918694|NCT01033747|B3|Baseline|Total|Total of all reporting groups
918695|NCT01033747|B2|Baseline|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
918696|NCT01033747|B1|Baseline|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
918697|NCT01033747|P2|Participant Flow|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
918698|NCT01033747|P1|Participant Flow|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
918699|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
918700|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
918774|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918701|NCT01033747|O2|Outcome|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO) subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg to 30 mg/kg/day deferasirox orally daily at the beginning of the 5-year non-comparative extension study
918702|NCT01033747|O1|Outcome|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on deferasirox treatment during the comparative prolongation study (NCT00379483) and at the beginning of the 5-year non-comparative extension study
918703|NCT01033747|E2|Reported Event|Deferasirox Crossover|Deferasirox Crossover group consists of participants who were initially randomized to 40 mg/kg/day deferoxamine (DFO)subcutaneously in the main study and comparative prolongation study and crossed over to 5 mg/kg to 30 mg/kg deferasirox orally daily at the beginning of the 5-year non-comparative extension study.
918704|NCT01033747|E1|Reported Event|Deferasirox|Deferasirox group consists of all participants who were initially randomized to 10 mg/kg or 20 mg/kg deferasirox orally daily in the main study and remained on the same deferasirox treatment during the comparative prolongation study(NCT00379483)and at the beginning of the 5-year non-comparative extension study
918705|NCT01033734|B1|Baseline|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight ≤23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918706|NCT01033734|P1|Participant Flow|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily (every 12 hours) intravenously (IV) over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to (≤) 23 kilogram (kg) received 3 milligrams per kilogram (mg/kg); participants with body weight more than (>) 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 milligrams (mg). For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918707|NCT01033734|O4|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918708|NCT01033734|O3|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918709|NCT01033734|O2|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
923605|NCT01019486|B4|Baseline|Total|Total of all reporting groups
918710|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918711|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918712|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918713|NCT01033734|O1|Outcome|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
919722|NCT01030965|B5|Baseline|Total|Total of all reporting groups
918714|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918715|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918716|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918717|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918718|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918719|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918806|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918807|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918808|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
925126|NCT01015703|O5|Outcome|10 mg Dose|10 mg CoVaccine HT
918720|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918721|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918722|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918723|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918775|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918776|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918724|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918725|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918726|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918727|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918728|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918729|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918730|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918731|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918732|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918733|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918777|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
918778|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
918734|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918735|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918736|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918737|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918738|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918739|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918740|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918741|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918742|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918743|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918779|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918780|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918744|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918745|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918746|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918747|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918748|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918749|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918750|NCT01033734|O3|Outcome|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918751|NCT01033734|O2|Outcome|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918752|NCT01033734|O1|Outcome|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily (every 12 hours) IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight less than or equal to 23 kg received 3 mg/kg; participants with body weight more than 23 kg to 40 kg received 2.5 mg/kg; and participants with body weight more than 40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918753|NCT01033734|E4|Reported Event|Oseltamivir: 1 to 2 Years|Participants aged 1 to 2 Years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918781|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918782|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
918832|NCT01033383|P1|Participant Flow|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
918754|NCT01033734|E3|Reported Event|Oseltamivir: 3 to 5 Years|Participants aged 3 to 5 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918755|NCT01033734|E2|Reported Event|Oseltamivir: 6 to 12 Years|Participants aged 6 to 12 years received oseltamivir twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <=23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight >40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918756|NCT01033734|E1|Reported Event|Oseltamivir: Overall|Participants received oseltamivir (Tamiflu) twice daily IV over 5 or 6 days for a total of 10 doses. The oseltamivir doses were based on participant’s body weight. Participants with body weight <= 23 kg received 3 mg/kg; participants with body weight ˃23 kg to 40 kg received 2.5 mg/kg; and participants with body weight ˃40 kg received 100 mg. For participants who did not receive all 10 doses IV, treatment could be completed with oral oseltamivir suspension (twice daily). If medically necessary, participants were allowed to receive an additional 10 doses of IV or oral oseltamivir after the initial 10 doses.
918757|NCT01033565|B1|Baseline|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
918758|NCT01033565|P1|Participant Flow|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
918759|NCT01033565|O1|Outcome|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
918760|NCT01033565|E1|Reported Event|Natrol|"Subjects receive Natrol (sustained release melatonin) 5mg tablet 30 minutes prior to bedtime for 10 to 14 days~Natrol : 5mg of sustained released melatonin. One tablet given 30 minutes prior to bedtime."
918761|NCT01033487|B1|Baseline|Entire Study Population|Includes all participants randomized to receive PBO Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 180 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 580 mcg dry powder first, PBO Spiriva (tiotropium) 18 mcg capsule along with PF-03635659 1450 mcg dry powder first, Spiriva (tiotropium) 18 mcg capsule along with PBO PF-03635659 dry powder first.
918809|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918810|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918811|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918812|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918762|NCT01033487|P10|Participant Flow|PF-03635659 580,PF-03635659 180,PF-03635659 1450,PBO,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
918763|NCT01033487|P9|Participant Flow|PF-03635659 180,PBO,PF-03635659 580,Spiriva18,PF-03635659 1450|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
918764|NCT01033487|P8|Participant Flow|PBO,Spiriva18,PF-03635659 180,PF-03635659 1450,PF-03635659 580|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
918783|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
918784|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918785|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918786|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918787|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
947799|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
918765|NCT01033487|P7|Participant Flow|Spiriva18,PF-03635659 1450,PBO,PF-03635659 580,PF-03635659 180|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
918766|NCT01033487|P6|Participant Flow|PF-03635659 1450,PF-03635659 580,Spiriva18,PF-03635659 180,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva (tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium)18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated byat least 7 days.
918767|NCT01033487|P5|Participant Flow|Spiriva18,PBO,PF-03635659 1450,PF-03635659 180,PF-03635659 580|Single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
918813|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918814|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
920324|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
918768|NCT01033487|P4|Participant Flow|PF-03635659 1450,Spiriva18,PF-03635659 580,PBO,PF-03635659 180|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in first intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in second intervention period,single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(Tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in fifth intervention period. Each period was separated by at at least 7 days.
918769|NCT01033487|P3|Participant Flow|PF-03635659 580,PF-03635659 1450,PF-03635659 180,Spiriva18,PBO|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in second intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in third intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
918770|NCT01033487|P2|Participant Flow|PF-03635659 180,PF-03635659 580,PBO,PF-03635659 1450,Spiriva18|Single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in second intervention period,single oral inhalation dose of placebo matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fourth intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in fifth intervention period. Each period was separated by at least 7 days.
918771|NCT01033487|P1|Participant Flow|PBO,PF-03635659 180,Spiriva18,PF-03635659 580,PF-03635659 1450|Single oral inhalation dose of placebo (PBO) matched with Spiriva(tiotropium) 18 microgram (mcg) capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in first intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 180 mcg dry powder in second intervention period;single oral inhalation dose of Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PBO matched with PF-03635659 dry powder in third intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 580 mcg dry powder in fourth intervention period;single oral inhalation dose of PBO matched with Spiriva(tiotropium) 18 mcg capsule along with single oral inhalation dose of PF-03635659 1450 mcg dry powder in fifth intervention period. Each period was separated by at least 7 days.
918772|NCT01033487|O5|Outcome|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
918773|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
918788|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
918789|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918790|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918791|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918792|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918793|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918794|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918795|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918796|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918797|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918798|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918799|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918800|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918801|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918802|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918803|NCT01033487|O2|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918804|NCT01033487|O1|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918805|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918815|NCT01033487|O4|Outcome|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
918816|NCT01033487|O3|Outcome|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918817|NCT01033487|O2|Outcome|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918818|NCT01033487|O1|Outcome|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918819|NCT01033487|E5|Reported Event|Placebo|Single oral inhalation dose of matched placebo in any of the five intervention periods.
918820|NCT01033487|E4|Reported Event|Spiriva (Tiotropium) 18 mcg|Single oral inhalation dose of Spiriva (tiotropium) 18 mcg capsule in any of the five intervention periods.
918821|NCT01033487|E3|Reported Event|PF-03635659 1450 mcg|Single oral inhalation dose of PF-03635659 1450 mcg dry powder in any of the five intervention periods.
918822|NCT01033487|E2|Reported Event|PF-03635659 580 mcg|Single oral inhalation dose of PF-03635659 580 mcg dry powder in any of the five intervention periods.
918823|NCT01033487|E1|Reported Event|PF-03635659 180 mcg|Single oral inhalation dose of PF-03635659 180 mcg dry powder in any of the five intervention periods.
918824|NCT01033383|B5|Baseline|Total|Total of all reporting groups
918825|NCT01033383|B4|Baseline|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
918826|NCT01033383|B3|Baseline|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
918827|NCT01033383|B2|Baseline|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
918828|NCT01033383|B1|Baseline|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
918829|NCT01033383|P4|Participant Flow|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
918830|NCT01033383|P3|Participant Flow|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
918831|NCT01033383|P2|Participant Flow|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
918833|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
918834|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
918835|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
918836|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
918837|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
918838|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
918839|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
918840|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
918841|NCT01033383|O4|Outcome|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
918842|NCT01033383|O3|Outcome|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
918843|NCT01033383|O2|Outcome|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
918844|NCT01033383|O1|Outcome|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
918845|NCT01033383|E4|Reported Event|3 Cranberry Capsules|"3 active cranberry capsules qd~3 cranberry capsules : 3 36mg cranberry capsules qhs"
918846|NCT01033383|E3|Reported Event|2 Cranberry Capsules & 1 Placebo Capsule|"2 active cranberry capsules and 1 placebo capsule qd~2 cranberry capsules & 1 placebo capsule : 2 36mg cranberry capsules, 1 placebo capsule, all qhs"
918847|NCT01033383|E2|Reported Event|1 Cranberry Capsule & 2 Placebo Capsules|"1 active cranberry capsule and 2 placebo capsules qd~1 cranberry capsule & 2 placebo capsules : 1 36mg cranberry capsule, 2 36mg placebo capsules, all qhs"
918848|NCT01033383|E1|Reported Event|3 Placebo Capsules|"3 placebo capsules qd~Placebo : Three placebo capsules, each 36mg, qhs"
918849|NCT01033227|B3|Baseline|Total|Total of all reporting groups
918850|NCT01033227|B2|Baseline|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
918851|NCT01033227|B1|Baseline|No Drug|
918852|NCT01033227|P2|Participant Flow|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
918853|NCT01033227|P1|Participant Flow|No Drug|This group did not receive anything additional in the no drug arm. The treatment group received the study drug and the non treatment group received no drug.
918854|NCT01033227|O2|Outcome|Sodium Nitrite Injection, USP|Administration of sodium nitrite injection, USP
918855|NCT01033227|O1|Outcome|No Drug|Will not receive study drug, there is no placebo in this study. The patient will know they are not receiving the study drug.
918856|NCT01033227|E2|Reported Event|Sodium Nitrite Injection, USP|"Administration if sodium nitrite injection, USP~sodium nitrite injection, usp: Sodium nitrite injection, USP will be administered in blocks of six subjects (3 sodium nitrite and 3 no drug). A total of five dose levels are planned, pending safety starting. Drug will be given by continuous infusion infusion for 48 hours starting at 6 nmol/min/kg (10% of the maximal tolerated dose)."
918857|NCT01033227|E1|Reported Event|No Drug|This group received no study drug and no placebo. They received standard of care treatment.
918858|NCT01033071|B4|Baseline|Total|Total of all reporting groups
918859|NCT01033071|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918860|NCT01033071|B2|Baseline|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918861|NCT01033071|B1|Baseline|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918923|NCT01033032|P4|Participant Flow|Dose Level 4|Amrubicin - 120 mg/m^2 every 21 days
918924|NCT01033032|P3|Participant Flow|Dose Level 3|Amrubicin - 110 mg/m^2 IV every 21 days
918925|NCT01033032|P2|Participant Flow|Dose Level 2|Amrubicin - 100 mg/m^2 IV every 21 days
918862|NCT01033071|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918863|NCT01033071|P2|Participant Flow|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918864|NCT01033071|P1|Participant Flow|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918865|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918866|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918867|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918868|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918960|NCT01032928|O2|Outcome|One Week Post-intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
918869|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918870|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918871|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918872|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918873|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918926|NCT01033032|P1|Participant Flow|Dose Level 1|Amrubicin - 90 mg/m^2 by intravenous (IV) every 21 days
918874|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918875|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918876|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918877|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918878|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918879|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918880|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
925127|NCT01015703|O4|Outcome|7 mg Dose|7 mg CoVaccine HT
918881|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918882|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918883|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918884|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918885|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918927|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
918928|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
918886|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918887|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918888|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918889|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918890|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918891|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918892|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918893|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918894|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918895|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918896|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918897|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918929|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
918930|NCT01033032|O1|Outcome|Amrubicin|Systemic therapy with amrubicin
918898|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918899|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918900|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918901|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918902|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918903|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918904|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918905|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918906|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918907|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918908|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918909|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918931|NCT01033032|E1|Reported Event|Dose Level 3|Includes patients treated at the MTD (Dose Level 3)
918932|NCT01033019|B3|Baseline|Total|Total of all reporting groups
918910|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918911|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918912|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918913|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918914|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918915|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918916|NCT01033071|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918917|NCT01033071|O2|Outcome|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918918|NCT01033071|O1|Outcome|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918919|NCT01033071|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily and azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to olmesartan medoxomil 40 mg and hydrochlorothiazide 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg combination tablets, orally, once daily for the next 4 weeks."
918920|NCT01033071|E2|Reported Event|Azilsartan Medoxomil 40-80mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918921|NCT01033071|E1|Reported Event|Azilsartan Medoxomil 20-40mg/Chlorthalidone 12.5-25mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily and olmesartan and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 4 weeks.~Participants will be force titrated at Week 4 to azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for the next 4 weeks.~Participants will then be force titrated at Week 8 to azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for the next 4 weeks."
918922|NCT01033032|B1|Baseline|All Patients|Includes all Phase I and Phase II patients treated at all dose levels (total enrollment = 78 patients)
918933|NCT01033019|B2|Baseline|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
918934|NCT01033019|B1|Baseline|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
918935|NCT01033019|P2|Participant Flow|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
918936|NCT01033019|P1|Participant Flow|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
918937|NCT01033019|O2|Outcome|Vehicle|Participants topically applied matching placebo cream twice daily for 6 weeks.
918938|NCT01033019|O1|Outcome|LDE225 0.75%|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
918939|NCT01033019|E3|Reported Event|LDE225 0.75% - nBCC|
918940|NCT01033019|E2|Reported Event|Vehicle - sBCC|Participants topically applied matching placebo cream twice daily for 6 weeks.
918941|NCT01033019|E1|Reported Event|LDE225 0.75% - sBCC|Participants topically applied 0.75% LDE225 cream twice daily for 6 weeks.
918942|NCT01032993|B3|Baseline|Total|Total of all reporting groups
918943|NCT01032993|B2|Baseline|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
918944|NCT01032993|B1|Baseline|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
918945|NCT01032993|P2|Participant Flow|Placebo|The Placebo arm used placebo wafers taken as three wafers two times daily for 4 weeks. Placebo wafers contained the same excipients as the active wafers, but contained no active CoQ10. The wafers looked and tasted identical to active agent, and were manufactured by the same manufacturer of the active agent, Tishcon Corp (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
918946|NCT01032993|P1|Participant Flow|Coenzyme Q10|The Coenzyme Q10 arm used 600 mg of CoQ10 taken as 300 mg (three 100 mg wafers) two times daily for 4 weeks. Active study wafers were ChewQ (ubidecarenone) and were manufactured by Tishcon Corp, (Westbury, NY). All participants randomized to either arm were instructed to continue use of simvastatin 20 mg daily
918947|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
918948|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
918949|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
918950|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
918951|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
918952|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
918953|NCT01032993|O2|Outcome|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
918954|NCT01032993|O1|Outcome|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
918955|NCT01032993|E2|Reported Event|Placebo|Placebo 2 x daily + Simvastatin 20 mg daily
918956|NCT01032993|E1|Reported Event|Coenzyme Q10|CoQ10 300 mg 2 x daily + Simvastatin 20 mg daily
918957|NCT01032928|B1|Baseline|Respiratory-Swallow Phase Training|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
918958|NCT01032928|P1|Participant Flow|Respiratory - Swallow Phase Training|Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns
918959|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were reassessed at one month post treatment
918962|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
918963|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
918964|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
918965|NCT01032928|O3|Outcome|One Month Post Intervention|VAMC participants were assessed at one month following completion of the treatment protocol
918966|NCT01032928|O2|Outcome|One Week Post Intervention|Subjects that completed treatment were assessed within one week of meeting respiratory-swallow phase training goals
918967|NCT01032928|O1|Outcome|Pre-intervention|Subjects eligible for enrollment
918968|NCT01032928|E1|Reported Event|Arm 1|"Chronically dysphagic, medically stable patients at least 6 months post treatment for head and neck cancer with non-optimal respiratory-swallowing patterns~Respiratory-Swallow Phase training: Will present patients with visually guided, respiratory feedback and train optimal respiratory-swallow coordination patterns, thereby providing the airway protection and mechanical benefits that have been observed in healthy individuals."
918969|NCT01032915|B5|Baseline|Total|Total of all reporting groups
918970|NCT01032915|B4|Baseline|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
918971|NCT01032915|B3|Baseline|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
918972|NCT01032915|B2|Baseline|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
918973|NCT01032915|B1|Baseline|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
918974|NCT01032915|P4|Participant Flow|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
918975|NCT01032915|P3|Participant Flow|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
918976|NCT01032915|P2|Participant Flow|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
918977|NCT01032915|P1|Participant Flow|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
918978|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
918979|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
920065|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
918980|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
918981|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
918982|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
918983|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
918984|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
918985|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
918986|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
918987|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
918988|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
918989|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
918990|NCT01032915|O4|Outcome|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
918991|NCT01032915|O3|Outcome|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
918992|NCT01032915|O2|Outcome|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
918993|NCT01032915|O1|Outcome|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
918994|NCT01032915|E4|Reported Event|Placebo s.c Every 2 Weeks|Placebo s.c weekly for 3 weeks, then every 2 weeks
918995|NCT01032915|E3|Reported Event|AIN457 150mg s.c Every 4 Weeks|AIN457 150mg s.c at baseline and Week 2, then every 4 weeks
918996|NCT01032915|E2|Reported Event|AIN457 300mg s.c Every 4 Weeks|AIN457 300mg s.c at baseline and Week 2, then every 4 weeks
918997|NCT01032915|E1|Reported Event|AIN457 300mg s.c Every 2 Weeks|AIN457 300mg s.c weekly for 3 weeks, then every 2 weeks
918998|NCT01032889|B4|Baseline|Total|Total of all reporting groups
918999|NCT01032889|B3|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919000|NCT01032889|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919001|NCT01032889|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919002|NCT01032889|P3|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919003|NCT01032889|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919004|NCT01032889|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919005|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919006|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919007|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919008|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919009|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919010|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919011|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919012|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919013|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919014|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919015|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919016|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919017|NCT01032889|O3|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919133|NCT01032694|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919018|NCT01032889|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919019|NCT01032889|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919020|NCT01032889|E3|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919021|NCT01032889|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received deoxycholic acid 2 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919022|NCT01032889|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received deoxycholic acid 1 mg/cm² administered in 0.2 mL injections, up to 10 mL per treatment session at intervals of approximately 1 month for up to a maximum of 6 treatments.
919023|NCT01032850|B1|Baseline|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
919024|NCT01032850|P1|Participant Flow|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
919025|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
919026|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
919027|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
919028|NCT01032850|O1|Outcome|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
919049|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
925128|NCT01015703|O3|Outcome|5 mg Dose|5 mg CoVaccine HT
919029|NCT01032850|E1|Reported Event|Arm 1: Sorafenib & Capecitabine|"Intervention: Sorafenib & Capecitabine: Sorafenib twice a day by mouth (400 mg) Capecitabine twice a day by mouth (850 mg)~Sorafenib & Capecitabine: Intervention: Sorafenib twice a day by mouth (400 mg), Capecitabine twice a day by mouth (850 mg). One cycle of treatment will consist of capecitabine on days 1-7 and 15-22 while sorafenib will be given daily continuously. Cycles will be repeated every 28 days."
919030|NCT01032837|B5|Baseline|Total|Total of all reporting groups
919031|NCT01032837|B4|Baseline|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919032|NCT01032837|B3|Baseline|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919033|NCT01032837|B2|Baseline|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919034|NCT01032837|B1|Baseline|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919035|NCT01032837|P4|Participant Flow|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919036|NCT01032837|P3|Participant Flow|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919037|NCT01032837|P2|Participant Flow|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919059|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919038|NCT01032837|P1|Participant Flow|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919039|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919040|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919041|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919042|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919043|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919044|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919045|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919046|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919047|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919048|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919113|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919050|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919051|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919052|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919053|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919054|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919055|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919056|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919057|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919058|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919060|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919061|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919062|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919063|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919064|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919065|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919066|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919067|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919068|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919069|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919070|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919071|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919072|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919073|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919074|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919075|NCT01032837|O4|Outcome|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919076|NCT01032837|O3|Outcome|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919077|NCT01032837|O2|Outcome|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919078|NCT01032837|O1|Outcome|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919079|NCT01032837|E4|Reported Event|Oseltamivir High Dose 10 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 10 days. Children aged 1- 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 10 days.
919080|NCT01032837|E3|Reported Event|Oseltamivir High Dose 5 Days|Adults and children 13 years and older received 150 mg (2 x 75 mg) oseltamivir capsules twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 60 to 150 mg) oseltamivir suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919081|NCT01032837|E2|Reported Event|Oseltamivir Standard Dose 10 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 10 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 10 days.
919082|NCT01032837|E1|Reported Event|Oseltamivir Standard Dose 5 Days|Adults and children 13 years and older received 75 mg oseltamivir and a placebo capsule twice daily for 5 days. Children aged 1 - 12 years received a weight-based dose (from 30 to 75 mg) oseltamivir suspension and placebo suspension orally twice daily for 5 days. Participants received matching placebo for the second 5 days of treatment.
919083|NCT01032759|B3|Baseline|Total|Total of all reporting groups
919084|NCT01032759|B2|Baseline|Placebo|"Placebo~Placebo: BID"
919085|NCT01032759|B1|Baseline|Memantine|Memantine: 20 mg, BID
919086|NCT01032759|P2|Participant Flow|Placebo|"Placebo~Placebo: BID"
919087|NCT01032759|P1|Participant Flow|Memantine|Memantine: 20 mg, BID
919088|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
919089|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
919090|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
919091|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
919092|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
919093|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
919094|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
919095|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
919096|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
919097|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
919098|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
919099|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
919100|NCT01032759|O2|Outcome|Placebo|"Placebo~Placebo: BID"
919101|NCT01032759|O1|Outcome|Memantine|Memantine: 20 mg, BID
919102|NCT01032759|E2|Reported Event|Placebo|"Placebo~Placebo: BID"
919103|NCT01032759|E1|Reported Event|Memantine|Memantine: 20 mg, BID
919104|NCT01032733|B3|Baseline|Total|Total of all reporting groups
919105|NCT01032733|B2|Baseline|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919106|NCT01032733|B1|Baseline|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
919107|NCT01032733|P2|Participant Flow|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919108|NCT01032733|P1|Participant Flow|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
919109|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919110|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
919111|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919112|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
919114|NCT01032733|O1|Outcome|Lifestyle Counseling|
919115|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919116|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
919117|NCT01032733|O2|Outcome|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919118|NCT01032733|O1|Outcome|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
919119|NCT01032733|E2|Reported Event|Educational Control|Participants in the educational control group attended monthly health education lectures on topics unrelated to weight loss.
919120|NCT01032733|E1|Reported Event|Lifestyle Counseling|In the experimental condition, participants attended a group-based weight management session plus three supervised exercise sessions each week.
919121|NCT01032694|B3|Baseline|Total|Total of all reporting groups
919122|NCT01032694|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919123|NCT01032694|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919124|NCT01032694|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919125|NCT01032694|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919126|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919127|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919128|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919129|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919130|NCT01032694|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919131|NCT01032694|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919132|NCT01032694|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
920066|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
919134|NCT01032538|B1|Baseline|Patients With Knee Osteoarthritis|Patients eglible for medial unicompartmental knee replacement
919135|NCT01032538|P1|Participant Flow|Patients With Knee Osteoarthritis|Patients eglible for unicondylar knee replacement
919136|NCT01032538|O1|Outcome|Passive ROM 2 Years|Range of motion measured by physiotherapist
919137|NCT01032538|O2|Outcome|KOOS ADL 2 Years|Activities of dayly living score
919138|NCT01032538|O1|Outcome|KOOS Pain 2 Years|Knee pain score, one of 5 subscores of KOOS
919139|NCT01032538|E1|Reported Event|Patients With Knee Osteoarthritis|Patients eglible for unicompartmental knee replacement
919140|NCT01032382|B3|Baseline|Total|Total of all reporting groups
919141|NCT01032382|B2|Baseline|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919142|NCT01032382|B1|Baseline|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919143|NCT01032382|P2|Participant Flow|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919144|NCT01032382|P1|Participant Flow|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919145|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919146|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919147|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919148|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919149|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919150|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919151|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919152|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919153|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919154|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919155|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919156|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919157|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919158|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919159|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919160|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919161|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919162|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919163|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919164|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919165|NCT01032382|O2|Outcome|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919166|NCT01032382|O1|Outcome|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919167|NCT01032382|E2|Reported Event|WR 279,396|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream): topical application to CL lesions once daily for 20 days
919168|NCT01032382|E1|Reported Event|Paromomycin Alone Treatment|Paromomycin Alone Cream (15% paromomycin topical cream): topical application to CL lesions once daily for 20 days
919169|NCT01032291|B4|Baseline|Total|Total of all reporting groups
919170|NCT01032291|B3|Baseline|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919171|NCT01032291|B2|Baseline|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919172|NCT01032291|B1|Baseline|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919173|NCT01032291|P3|Participant Flow|Lenalidomide + Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919174|NCT01032291|P2|Participant Flow|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919175|NCT01032291|P1|Participant Flow|Lenalidomide + Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919176|NCT01032291|O2|Outcome|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919177|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919178|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919179|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919180|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919181|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919182|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919183|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919184|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919185|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919186|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919187|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919188|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919189|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919190|NCT01032291|O3|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919191|NCT01032291|O2|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919192|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-In)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919193|NCT01032291|O2|Outcome|Lenalidomide Plus Cetuximab (Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during the Proof of Concept period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919194|NCT01032291|O1|Outcome|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919195|NCT01032291|O1|Outcome|Lenalidomide Plus Cetuximab (Safety Lead-in)|Combination therapy of lenalidomide plus cetuximab during the Safety Lead-in period. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919196|NCT01032291|E2|Reported Event|Lenalidomide + Cetuximab (Safety Lead-in and Proof of Concept)|Combination therapy of lenalidomide plus cetuximab during both the Safety Lead-in and Proof of Concept periods. Lenalidomide dose of 25 mg/day in combination with cetuximab (IV injections of 400 mg/m^2 first infusion only, then 250 mg/m^2 subsequently administered on Days 1, 8, 15, and 22 of each 28-day cycle).
919197|NCT01032291|E1|Reported Event|Lenalidomide (Proof of Concept)|Single agent therapy of lenalidomide (25 mg/day) during the Proof of Concept period.
919198|NCT01032265|B3|Baseline|Total|Total of all reporting groups
919199|NCT01032265|B2|Baseline|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919200|NCT01032265|B1|Baseline|Postal Treatment|Information (including life style), and PFMT exercises.
919201|NCT01032265|P2|Participant Flow|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919202|NCT01032265|P1|Participant Flow|Postal Treatment|Information (including life style), and PFMT exercises.
919203|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919204|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
919205|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919206|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
919207|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919208|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
919209|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919210|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
919211|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919212|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
919213|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919214|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
919215|NCT01032265|O2|Outcome|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919216|NCT01032265|O1|Outcome|Postal Treatment|Information (including life style), and PFMT exercises.
919217|NCT01032265|E2|Reported Event|Internet-based Treatment|Internet-based treatment with information (including life style), PFMT, elements of CBT and regular mail contact with an urotherapist
919218|NCT01032265|E1|Reported Event|Postal Treatment|Information (including life style), and PFMT exercises.
919219|NCT01032200|B3|Baseline|Total|Total of all reporting groups
919220|NCT01032200|B2|Baseline|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919221|NCT01032200|B1|Baseline|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
919222|NCT01032200|P2|Participant Flow|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919223|NCT01032200|P1|Participant Flow|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
919224|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919225|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
925129|NCT01015703|O2|Outcome|2 mg Dose|2 mg CoVaccine HT
919226|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919227|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
919228|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919229|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
919230|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919231|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
919232|NCT01032200|O2|Outcome|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919233|NCT01032200|O1|Outcome|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
919234|NCT01032200|E2|Reported Event|Arm II - Placebo|"Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
919235|NCT01032200|E1|Reported Event|Arm I - Armodafinil|"Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.~Armodafinil: Given orally"
919236|NCT01032174|B3|Baseline|Total|Total of all reporting groups
919237|NCT01032174|B2|Baseline|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919238|NCT01032174|B1|Baseline|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
947800|NCT00959751|E2|Reported Event|Placebo|3 x 0 mg capsules, PRN
919239|NCT01032174|P2|Participant Flow|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919240|NCT01032174|P1|Participant Flow|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919241|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919242|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919243|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919244|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919245|NCT01032174|O2|Outcome|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919246|NCT01032174|O1|Outcome|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919247|NCT01032174|E2|Reported Event|Amoxiclav|Amoxiclav 1000 mg tablet administered twice daily (BID) orally for 10 days.
919248|NCT01032174|E1|Reported Event|Azithromycin|A single dose of azithromycin 2000 milligram (mg) sustained release (SR) tablet administered orally.
919249|NCT01032135|B6|Baseline|Total|Total of all reporting groups
919250|NCT01032135|B5|Baseline|MI-IOP Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized back to IOP.~Motivational Interviewing: 2 sessions at week 2."
919251|NCT01032135|B4|Baseline|MI-PC Engaged at 2 Weeks, Non-engaged Before 8 Weeks|"Participants began treatment in IOP and were engaged at week 2. However, they dropped out of treatment between weeks 3 - 8. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919252|NCT01032135|B3|Baseline|MI-IOP Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized back to IOP.~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919253|NCT01032135|B2|Baseline|MI-PC Non-Engaged|"Participants began treatment in IOP but were not engaged at week 2. Randomized to receive patient choice.~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919254|NCT01032135|B1|Baseline|Engaged|Participants began treatment in IOP, consistently remained engaged in IOP throughout the study time period. This group did not reach the threshold of needing study intervention.
919255|NCT01032135|P7|Participant Flow|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919256|NCT01032135|P6|Participant Flow|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919546|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Number of participants achieving a Complete Response (CR) up to 24 hours after receiving fosaprepitant
919257|NCT01032135|P5|Participant Flow|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919258|NCT01032135|P4|Participant Flow|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919259|NCT01032135|P3|Participant Flow|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919260|NCT01032135|P2|Participant Flow|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919261|NCT01032135|P1|Participant Flow|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919262|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919263|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919264|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919265|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919266|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919267|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919268|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919269|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919270|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919271|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919272|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919273|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919274|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919275|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919276|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919277|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919278|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919279|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919280|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919281|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919282|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919283|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919284|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919285|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919286|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919287|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919288|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919289|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919290|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919291|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919292|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919293|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919294|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919295|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919296|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919297|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919298|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919299|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919300|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919301|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919302|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919303|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919304|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919305|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919306|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919307|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919308|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919309|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919310|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919311|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919312|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919313|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919314|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919315|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919316|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919317|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919318|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919319|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919320|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919321|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919322|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919323|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919324|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919325|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919326|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919327|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919328|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919329|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919330|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919331|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919332|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919333|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919334|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919335|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919336|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919337|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919338|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919339|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919340|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919341|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919342|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919343|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919344|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919345|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919346|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919347|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919348|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919349|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919350|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919351|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919352|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919353|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919354|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919355|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919356|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919357|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919358|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919359|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919360|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919361|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919362|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919363|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919364|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919365|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919366|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919367|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919368|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919369|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919370|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919371|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919372|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919373|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919374|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919375|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919376|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919377|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919378|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919379|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919380|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919381|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919382|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919383|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919384|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919385|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919386|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919387|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919388|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919389|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919390|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919391|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919392|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919393|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919394|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919395|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919396|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919397|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919398|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919399|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919400|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919401|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919402|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919403|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919404|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919405|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919406|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919407|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919408|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919409|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919410|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919411|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919412|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919413|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919414|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919415|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919416|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919417|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919418|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919419|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919420|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919421|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919422|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919423|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919424|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919425|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919426|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919427|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919428|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919429|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919430|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919431|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919432|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919433|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919434|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919435|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919436|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919437|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919438|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919439|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919440|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919441|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919442|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919443|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919444|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919445|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919446|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919447|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919448|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919449|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919450|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919451|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919452|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919453|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919454|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919455|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919456|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919457|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919458|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919459|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919460|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919461|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919462|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919463|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919464|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919465|NCT01032135|O7|Outcome|No Further Intervention|"Not engaged at week 2 and still not engaged at week 8.~Randomized to receive no further study intervention."
919466|NCT01032135|O6|Outcome|MI-PC Non-engaged at 2 Weeks, Still Non-engaged at 8 Weeks|"Began study in IOP but was nonengaged at week 2. Randomized to Patient Choice.~Motivational Interviewing: 2 sessions at week 2 presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919467|NCT01032135|O5|Outcome|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become nonengaged in weeks 3 - 8.~Motivational Interviewing: 2 sessions at time of disengagement.~Return to IOP therapy 3 times weekly for three hours a day"
919468|NCT01032135|O4|Outcome|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Randomized to treatment choice, but remain attending treatment as usual then dropped out of treatment after randomization.~Motivational Interviewing: 2 sessions at time of disengagement presenting treatment choices to participants.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for Naltrexone"
919469|NCT01032135|O3|Outcome|MI-IOP Non-Engaged at 2 Weeks|"Participants begin at IOP, but at 2 weeks are determined to no longer be engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919470|NCT01032135|O2|Outcome|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are not engaged. Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919471|NCT01032135|O1|Outcome|Engaged|"Engaged at week 2 and remained engaged throughout the 8 weeks of study participation.~This group did not receive any treatment intervention."
919472|NCT01032135|E5|Reported Event|MI-IOP Engaged at 2 Weeks, Disengage Before 8 Weeks|"Initially engaged at IOP, but become non-engaged in weeks 3 - 8.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2"
919473|NCT01032135|E4|Reported Event|MI-PC Engaged at 2 Weeks, Disengage Before 8 Weeks|"Participants start at IOP, Engaged at 2 weeks but disengage between 3 - 8 weeks.~Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919474|NCT01032135|E3|Reported Event|MI-IOP Non-Engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.~Randomized to IOP~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out."
919503|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919572|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
919475|NCT01032135|E2|Reported Event|MI-PC Non-engaged at 2 Weeks|"Participants start at IOP, but at 2 weeks are non-engaged.~Randomized to treatment choice:~Motivational Interviewing: 2 sessions at week 2, potential 2 sessions at week 8 if the participant drops out.~Telephone counseling: one telephone counseling session per week for 10 weeks.~Cognitive Behavioral Therapy (CBT) Counseling: One CBT session per week, for 10 weeks.~Medication Management: Prescription for naltrexone~Intensive OutPatient Therapy: Return to IOP, group therapy 3 times weekly for about three hours a day."
919476|NCT01032135|E1|Reported Event|Engaged|Engaged at week 2 and remained engaged throughout the 8 weeks of study participation. This group did not receive any treatment intervention.
919477|NCT01032070|B3|Baseline|Total|Total of all reporting groups
919478|NCT01032070|B2|Baseline|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919479|NCT01032070|B1|Baseline|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919480|NCT01032070|P2|Participant Flow|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919481|NCT01032070|P1|Participant Flow|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919482|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919483|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919484|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919485|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919486|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919487|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919488|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919489|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919547|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|This arm includes only those participants that required the use of second rescue drug after receiving Fosaprepitant
919490|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919491|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919492|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919493|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919494|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919495|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919496|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919497|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919498|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919499|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919500|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919501|NCT01032070|O2|Outcome|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919502|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919573|NCT01031706|O2|Outcome|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
919504|NCT01032070|O1|Outcome|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919505|NCT01032070|E2|Reported Event|Etoposide|Etoposide 50 mg/m^2 per day was administered orally for 21 days followed by a 7-day rest period until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919506|NCT01032070|E1|Reported Event|Erlotinib|Erlotinib was administered orally at a dose of 85 mg/m^2 per day continuously until either progression, death, patient request or investigator decision to discontinue study drug or intolerable toxicity.
919507|NCT01032044|B3|Baseline|Total|Total of all reporting groups
919508|NCT01032044|B2|Baseline|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
919509|NCT01032044|B1|Baseline|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
919510|NCT01032044|P2|Participant Flow|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
919511|NCT01032044|P1|Participant Flow|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
919512|NCT01032044|O2|Outcome|pCLE-guided Evaluation|"Endoscopic evaluation of BE guided by probe-based Confocal Laser Endomicroscopy (pCLE guided evaluation)~pCLE guided evaluation: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
919513|NCT01032044|O1|Outcome|Standard Endoscopic Evaluation|"Standard high-definition white light endoscopy guided evaluation~Standard endoscopic evaluation: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
919514|NCT01032044|E2|Reported Event|pCLE-guided Treatment|"Endoscopic treatment of BE guided by probe-based Confocal Laser Endomicroscopy~pCLE guided endoscopic treatment of BE: Treatment modalities include endoscopic mucosal resection, radio-frequency ablation, or photodynamic therapy. probe-based Confocal Laser Endomicroscopy is used to decide on re-treatment or not, and to guide and evaluate the treatment during the same endoscopic procedure."
919515|NCT01032044|E1|Reported Event|Standard Treatment|"Standard high-definition white light endoscopy guided treatment~Standard endoscopic treatment of BE: Treatment modalities can include endoscopic mucosal resection, radio-frequency ablation or photodynamic therapy"
919516|NCT01032018|B3|Baseline|Total|Total of all reporting groups
919744|NCT01030965|E3|Reported Event|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
919517|NCT01032018|B2|Baseline|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
919518|NCT01032018|B1|Baseline|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
919519|NCT01032018|P2|Participant Flow|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
919520|NCT01032018|P1|Participant Flow|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
919521|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
919522|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
919523|NCT01032018|O2|Outcome|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
919524|NCT01032018|O1|Outcome|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
919525|NCT01032018|E2|Reported Event|Stepped Care|The participant had a choice of Problem Solving Therapy (PST), pharmacotherapy, a combination of the two, or neither. The participant had a 15-minute information session on the benefits of drawbacks of each type of therapy and medication, after which the preferred treatment was chosen.
919569|NCT01031706|P2|Participant Flow|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
919570|NCT01031706|P1|Participant Flow|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
919526|NCT01032018|E1|Reported Event|Referred Care|The participant's primary care provider was notified in writing of the finding of elevated depressive symptoms and encouraged to implement a provider-preferred depression treatment. Depending on the provider's evaluation of the participant, he or she elected to defer depression treatment, to initiate it, or to refer the participant to a mental health specialist.
919527|NCT01031979|B3|Baseline|Total|Total of all reporting groups
919528|NCT01031979|B2|Baseline|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
919529|NCT01031979|B1|Baseline|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
919530|NCT01031979|P2|Participant Flow|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
919531|NCT01031979|P1|Participant Flow|Yohimbime Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
919532|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
919533|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
919534|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
919535|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
919536|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
919537|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
919538|NCT01031979|O2|Outcome|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
919539|NCT01031979|O1|Outcome|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
919540|NCT01031979|E2|Reported Event|Placebo Group|"Patients will take a placebo one hour before first imaginal exposure in PE.~Placebo: Placebo"
919541|NCT01031979|E1|Reported Event|Yohimbine Group|"Patients will take one 21.6 mg. dose of yohimbine one hour before first imaginal exposure in PE.~Yohimbine: alpha-2 adrenergic receptor antagonist"
919542|NCT01031953|B1|Baseline|Fosaprepitant|
919543|NCT01031953|P1|Participant Flow|Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
919544|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|Only those in the study arm above that self report headache, dizziness, or pain/soreness at the infusion site are considered in this outcome
919545|NCT01031953|O1|Outcome|Participants That Received Fosaprepitant|participants with self report fatigue or sedation after receiving fosaprepitant
920325|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
919548|NCT01031953|O1|Outcome|Participants Who Recieved Fosaprepitant|Number of participants who experienced vomiting episodes from baseline to 24 hours after receiving Fosaprepitant
919549|NCT01031953|O1|Outcome|Change in Nausea Score From 2 Hours to 12 and 24 Hours|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
919550|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
919551|NCT01031953|O1|Outcome|Participants Receiving Fosaprepitant|A 150mg dose of study drug given to participants who experience breakthrough nausea and vomiting after prophylactic anti emetics given with chemotherapy
919552|NCT01031953|E1|Reported Event|Fosaprepitant|
919553|NCT01031914|B1|Baseline|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
919554|NCT01031914|P1|Participant Flow|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have obstructive sleep apnea (OSA) and will be current CPAP users.
919555|NCT01031914|O1|Outcome|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
919556|NCT01031914|E1|Reported Event|Paced Breathing Sleep/Wake Detection|All subjects enrolled will have OSA and will be current CPAP users.
919557|NCT01031810|B1|Baseline|Tranylcypromine|patients will receive treatment with tranylcypromine
919558|NCT01031810|P1|Participant Flow|Tranylcypromine|Patients will receive treatment with tranylcypromine tablets taken orally on a twice daily schedule. Dosage was initially 10 mg daily and was increased weekly up to 120 mg daily.
919559|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
919560|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
919561|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
919562|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: MAO-Inhibitor 60mg-120mg"
919563|NCT01031810|O1|Outcome|Tranylcypromine|"patients will receive treatment with tranylcypromine~tranylcypromine: monoamine oxidase inhibitor (MAOI) 60mg-120mg"
919564|NCT01031810|O1|Outcome|Tranylcypromine|patients will receive treatment with tranylcypromine Baseline Hamd17
919565|NCT01031810|E1|Reported Event|Tranylcypromine|patients will receive treatment with tranylcypromine
919566|NCT01031706|B3|Baseline|Total|Total of all reporting groups
919567|NCT01031706|B2|Baseline|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
919568|NCT01031706|B1|Baseline|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
919574|NCT01031706|O1|Outcome|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
919575|NCT01031706|E2|Reported Event|Placebo|Placebo: 4 ml 0.12% NaCl inhaled three times a day x 28 days
919576|NCT01031706|E1|Reported Event|Hypertonic Saline|"6% NaCl, 4 ml TID via eFlow~Hypertonic Saline: inhaled HS (6% NaCl, 4mL) three times a day for 28 days"
919577|NCT01031680|B3|Baseline|Total|Total of all reporting groups
919578|NCT01031680|B2|Baseline|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919579|NCT01031680|B1|Baseline|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919580|NCT01031680|P2|Participant Flow|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919581|NCT01031680|P1|Participant Flow|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919582|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919583|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919584|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919585|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919586|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919587|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919588|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919589|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919590|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919591|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919592|NCT01031680|O2|Outcome|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919593|NCT01031680|O1|Outcome|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919594|NCT01031680|E2|Reported Event|Placebo Comparator|Placebo, Matching placebo tablet, oral, once daily
919595|NCT01031680|E1|Reported Event|Experimental|Dapagliflozin, 10 mg tablet, oral, once daily
919596|NCT01031628|B5|Baseline|Total|Total of all reporting groups
919597|NCT01031628|B4|Baseline|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919598|NCT01031628|B3|Baseline|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919599|NCT01031628|B2|Baseline|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919600|NCT01031628|B1|Baseline|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919601|NCT01031628|P4|Participant Flow|400, 600 or 800 mg for Patients With Exon 9 Mutation Tumors|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919602|NCT01031628|P3|Participant Flow|400 mg for Patients With Imatinib Blood Levels ≥ 1100|"Patients with imatinib trough blood levels ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919603|NCT01031628|P2|Participant Flow|600 or 800 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919604|NCT01031628|P1|Participant Flow|400 mg for Patients With Imatinib Blood Levels < 1100|"Patients with imatinib trough blood levels less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919605|NCT01031628|O4|Outcome|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919606|NCT01031628|O3|Outcome|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919607|NCT01031628|O2|Outcome|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919608|NCT01031628|O1|Outcome|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919609|NCT01031628|E4|Reported Event|Arm D|"Patients with tumors that harbor exon 9 mutations will continue imatinib mesylate at 400 mg or dose escalate up to 800 mg daily~Imatinib mesylate : 400, 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919610|NCT01031628|E3|Reported Event|Arm C|"Patients with blood level ≥1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919611|NCT01031628|E2|Reported Event|Arm B|"Patients with blood level less than 1100 dose adjust imatinib mesylate to goal blood level ≥1100 ng/mL~Imatinib mesylate : 600 or 800 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919612|NCT01031628|E1|Reported Event|Arm A|"Patients with blood level less than 1100 will continue imatinib 400 mg daily~Imatinib mesylate : 400 mg daily. Number of cycles: until disease progression or unacceptable toxicity develops"
919613|NCT01031550|B3|Baseline|Total|Total of all reporting groups
919645|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
919614|NCT01031550|B2|Baseline|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
919615|NCT01031550|B1|Baseline|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
919616|NCT01031550|P2|Participant Flow|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane, anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
919617|NCT01031550|P1|Participant Flow|Standard Anesthetic Management|standard anesthetic management propofol 100-150mcg/kg/min
919618|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
919619|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
919620|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
919621|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
919622|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane
919623|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management
919624|NCT01031550|O2|Outcome|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
919625|NCT01031550|O1|Outcome|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
919626|NCT01031550|E2|Reported Event|Preconditioning With 2 MAC Isoflurane Group|preconditioning with isoflurane , anesthesia will be maintained with 1MAC of Isoflurane according to age and end-expiratory concentration. Thirty minutes before the anticipated inflow occlusion and commencement of liver transaction, Isoflurane concentration will be gradually increased to 2 MAC over a period of 5 minutes (induction) and maintained at 2 MAC for 10 minutes (preconditioning). Then the concentration of Isoflurane will be decreased to 1 MAC during next 15 minutes (washout).
919627|NCT01031550|E1|Reported Event|Standard Anesthetic Management|standard anesthetic management with propofol 100-150mcg/kg/min
919628|NCT01031498|B4|Baseline|Total|Total of all reporting groups
919629|NCT01031498|B3|Baseline|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
919630|NCT01031498|B2|Baseline|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
920326|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
919631|NCT01031498|B1|Baseline|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
919632|NCT01031498|P3|Participant Flow|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
919633|NCT01031498|P2|Participant Flow|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
919634|NCT01031498|P1|Participant Flow|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
919635|NCT01031498|O3|Outcome|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
919636|NCT01031498|O2|Outcome|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
919637|NCT01031498|O1|Outcome|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
919638|NCT01031498|E3|Reported Event|Palonosetron Group 2 (3 Days)|Palonosetron once a day 0.25 mg IV injection on Days 1, 3, and 5 of chemotherapy, given over 30 seconds, 30 minutes before chemotherapy.
919639|NCT01031498|E2|Reported Event|Palonosetron Group 1 (5 Days)|Palonosetron once a day 0.25 mg IV injection for 5 days, given over 30 seconds, 30 minutes before chemotherapy.
919640|NCT01031498|E1|Reported Event|Ondansetron: Standard of Care|Standard of care, Ondansetron 8 mg intravenous (IV) as bolus followed by 24 mg IV from 30 minutes before chemotherapy until 12 hours after chemotherapy ends.
919641|NCT01031446|B1|Baseline|RAD001 Cisplatin Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
919642|NCT01031446|P1|Participant Flow|RAD001 and Cisplatin and Pacletaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks. All patients began at the same dose level of the study drugs with no de-escalation of dose, thus results for Phase I and II were combined
919643|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
919644|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
919714|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919715|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919646|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Patients receive cisplatin IV 25 mg/m2, paclitaxel IV 80 mg/m2 (both drugs once weekly for 3 weeks followed by 1 week of rest), and RAD001 5 mg by mouth daily. 1 cycle = 4 weeks.
919647|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitaxel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
919648|NCT01031446|O1|Outcome|RAD001 and Cisplatin and Paclitazel|Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. Everolimus (RAD001) po daily. One cycle = 4 weeks
919649|NCT01031446|E1|Reported Event|RAD001 and Cisplatin and Paclitaxel|RAD001 (Everolimus) by mouth once a day. Cisplatin intravenously (IV) weekly for 3 weeks, then 1 week of rest; paclitaxel IV weekly for 3 weeks, then 1 week of rest. One cycle = 4 weeks.
919650|NCT01031381|B1|Baseline|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
919651|NCT01031381|P1|Participant Flow|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
919652|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
919653|NCT01031381|O1|Outcome|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously.
919654|NCT01031381|E1|Reported Event|RAD001 + Bevacizumab|Patients with recurrent ovarian, peritoneal, and fallopian tube cancer who received RAD001 10 mg/day by mouth and bevacizumab 10 mg/kg intravenously
919655|NCT01031134|B3|Baseline|Total|Total of all reporting groups
919656|NCT01031134|B2|Baseline|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
919657|NCT01031134|B1|Baseline|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
919658|NCT01031134|P2|Participant Flow|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
919745|NCT01030965|E2|Reported Event|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
919659|NCT01031134|P1|Participant Flow|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
919660|NCT01031134|O2|Outcome|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
919661|NCT01031134|O1|Outcome|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
919662|NCT01031134|O2|Outcome|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
919663|NCT01031134|O1|Outcome|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
919664|NCT01031134|E2|Reported Event|Usual Care|"Physician Usual Care of depressed patients.~Usual Care: Usual Care reflects the standard of care in primary care practice: following physician recommendation for treatment. Physicians will recommend some form of depression treatment. This may take the form of an antidepressant prescription or psychotherapy referral. The physician will encourage patients to telephone with any questions. Following the treatment recommendation provided to the patient, the physician will provide care as usual."
919716|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919717|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919718|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919719|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919665|NCT01031134|E1|Reported Event|Shared Decision Making|"1 in person session followed by 2 telephone calls 1 and 2 weeks later.~Shared Decision Making: Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented."
919666|NCT01031095|B3|Baseline|Total|Total of all reporting groups
919667|NCT01031095|B2|Baseline|Standard Therapy|standard UFH treatment
919668|NCT01031095|B1|Baseline|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
919669|NCT01031095|P2|Participant Flow|Standard Therapy|standard unfractionated heparin (UFH) treatment
919670|NCT01031095|P1|Participant Flow|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
919671|NCT01031095|O1|Outcome|Low Dose Intracoronary Heparin Treatment Arm|low dose intracoronary heparin treatment arm (intracoronary 1000 IU unfractioned heparin arm)
919672|NCT01031095|O1|Outcome|Standard Therapy|standard UFH treatment (intravenous standard dose unfractioned heparin group)
919673|NCT01031095|E2|Reported Event|Standard Therapy|standard UFH treatment
919674|NCT01031095|E1|Reported Event|Low Dose Intracoronary Heparin|Low dose intracoronary heparin treatment arm
919675|NCT01031043|B1|Baseline|Topical Bethanechol|patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device
919676|NCT01031043|P1|Participant Flow|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
919677|NCT01031043|O1|Outcome|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
919746|NCT01030965|E1|Reported Event|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
919747|NCT01030952|B3|Baseline|Total|Total of all reporting groups
919748|NCT01030952|B2|Baseline|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
919749|NCT01030952|B1|Baseline|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
919678|NCT01031043|E1|Reported Event|Topical Bethanechol|"patients will be given either 5 mg (first phase) or 10 mg (second phase) of bethanechol in 1 ml of solution containing an absorption enhancer. Administration will be performed by throat spray device~Bethanechol: Taking part in this research study is voluntary. Patient may choose not to take part in this research study or may withdraw consent at any time. Their choice will not at any time affect the commitment of the health care providers to administer care. If the patient decides not to participate or withdraw from the study there will be no penalty or loss of benefits to which they are otherwise entitled."
919679|NCT01031004|B3|Baseline|Total|Total of all reporting groups
919680|NCT01031004|B2|Baseline|Etafilcon A|contact lens worn as single use, daily wear
919681|NCT01031004|B1|Baseline|Narafilcon B|single use, daily wear contact lens
919682|NCT01031004|P2|Participant Flow|Etafilcon A|contact lens worn as single use, daily wear
919683|NCT01031004|P1|Participant Flow|Narafilcon B|single use, daily wear contact lens
919684|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919685|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919686|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919687|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919688|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919689|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919690|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919691|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919692|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919693|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919694|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919695|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919696|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919697|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919698|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919699|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919700|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919701|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919702|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919703|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919704|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919705|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919706|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919707|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919708|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919709|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919710|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919711|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919712|NCT01031004|O2|Outcome|Etafilcon A|contact lens worn as single use, daily wear
919713|NCT01031004|O1|Outcome|Narafilcon B|single use, daily wear contact lens
919723|NCT01030965|B4|Baseline|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
919724|NCT01030965|B3|Baseline|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
919725|NCT01030965|B2|Baseline|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
919726|NCT01030965|B1|Baseline|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
919727|NCT01030965|P4|Participant Flow|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
919728|NCT01030965|P3|Participant Flow|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
919729|NCT01030965|P2|Participant Flow|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
919730|NCT01030965|P1|Participant Flow|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
919731|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
919732|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
919733|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
919734|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
919735|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
919736|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
919737|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
919738|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
919739|NCT01030965|O4|Outcome|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
919740|NCT01030965|O3|Outcome|UMEC 250 µg|Participants received UMEC 250 µg QD in the morning via a DPI for 28 days.
919741|NCT01030965|O2|Outcome|UMEC 125 µg|Participants received umeclidinium bromide (UMEC) 125 micrograms (µg) QD in the morning via a DPI for 28 days.
919742|NCT01030965|O1|Outcome|Placebo|Participants received matching placebo once daily (QD) in the morning via a dry powder inhaler (DPI) for 28 days.
919743|NCT01030965|E4|Reported Event|UMEC 500 µg|Participants received UMEC 500 µg QD in the morning via a DPI for 28 days.
919750|NCT01030952|P2|Participant Flow|Acarbose|patients in Acarbose group received Acarbose 50 mg by mouth, three times daily with the first bite of a meal
919751|NCT01030952|P1|Participant Flow|Nateglinide|120 mg by mouth, three times daily 10 minutes immediately before 3 meals
919752|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919753|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919754|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919755|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919756|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919757|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919758|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919759|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919760|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919761|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919762|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919763|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919764|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919765|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919766|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919767|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919768|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
919769|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
919770|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d.) with the first bite of a meal
919771|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d.) 10 minutes immediately before 3 meals
919772|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919773|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919774|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919775|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919776|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919777|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919778|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919779|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919780|NCT01030952|O2|Outcome|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919781|NCT01030952|O1|Outcome|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919782|NCT01030952|E2|Reported Event|Acarbose|50 mg by mouth, three times daily (P.O. t.i.d) with the first bite of a meal
919783|NCT01030952|E1|Reported Event|Nateglinide|120 mg by mouth, three times daily (P.O. t.i.d) 10 minutes immediately before 3 meals
919784|NCT01030822|B4|Baseline|Total|Total of all reporting groups
919785|NCT01030822|B3|Baseline|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919786|NCT01030822|B2|Baseline|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919787|NCT01030822|B1|Baseline|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919788|NCT01030822|P3|Participant Flow|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919789|NCT01030822|P2|Participant Flow|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919790|NCT01030822|P1|Participant Flow|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
920327|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
919791|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919792|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919793|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919794|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919795|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919796|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919797|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919798|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919948|NCT01029886|B2|Baseline|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919949|NCT01029886|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919799|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919800|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919801|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919802|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919803|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919804|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919805|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919806|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919807|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919808|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919809|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919810|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919811|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919812|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919813|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919814|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919815|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919816|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919950|NCT01029886|P2|Participant Flow|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
951216|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
919817|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919818|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919819|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919820|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919821|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919822|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919823|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919824|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919825|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919826|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919827|NCT01030822|O3|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919828|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919829|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919830|NCT01030822|O1|Outcome|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919831|NCT01030822|O2|Outcome|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919832|NCT01030822|O1|Outcome|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919833|NCT01030822|E3|Reported Event|Tritanrix-HepB+Hiberix Group|Unprimed subjects who were previously vaccinated with Tritanrix™-HepB and Hiberix™ vaccines in the Control Group of the 10PN-PD-DIT-037 (111188) study, received a catch-up vaccination with Synflorix™ vaccine (2 primary doses +1 booster dose), administered intramuscularly in the right or left thigh, during their second year of life: 2+1 catch-up vaccination starting at 12-18 months of age with an interval of at least 8 weeks (56-118 days) between primary doses; the booster dose was administered at 18-24 months of age.
919834|NCT01030822|E2|Reported Event|Synflorix 2 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 15-18 months of age.
919951|NCT01029886|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
920067|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
919835|NCT01030822|E1|Reported Event|Synflorix 1 Group|Subjects who were previously primed with a 3-dose primary vaccination of Synflorix™ vaccine in the 10PN-PD-DIT-037 (111188) study, received a booster dose of Synflorix™ vaccine, administered intramuscularly in the right or left thigh, at 9-18 months of age.
919836|NCT01030757|B1|Baseline|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
919837|NCT01030757|P1|Participant Flow|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
919838|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
919839|NCT01030757|O1|Outcome|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
919840|NCT01030757|E1|Reported Event|Tomotherapy|"Intervention: Stereotactic Body Radiation Therapy using Tomotherapy. Tomotherapy treatment: A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days. Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours. Dose will be prescribed to the isodose line which covers at least 90% of the PTV.~Tomotherapy treatment: -A total of 60 Gy using 12 Gy per fraction over 5 fractions to be given within 10 calendar days~Each fraction of 12 Gy will be divided into 2 fractions of 6 Gy given in one day within 6 hours~Dose will be prescribed to the isodose line which covers at least 90% of the PTV~Dose homogeneity +/- 5%"
919841|NCT01030718|B4|Baseline|Total|Total of all reporting groups
919842|NCT01030718|B3|Baseline|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919843|NCT01030718|B2|Baseline|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919844|NCT01030718|B1|Baseline|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919845|NCT01030718|P3|Participant Flow|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Philadelphia chromosome positive (Ph+) ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919846|NCT01030718|P2|Participant Flow|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919847|NCT01030718|P1|Participant Flow|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919848|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919849|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919850|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919851|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919852|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919853|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919854|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919855|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919930|NCT01030458|B1|Baseline|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
920328|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
919856|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919857|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919858|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919859|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919860|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919861|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919862|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919879|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919863|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919864|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919865|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919866|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919867|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919868|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919869|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919870|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919871|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919872|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919873|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919874|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919875|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919876|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919877|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919878|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919880|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919881|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919882|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919883|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919884|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919885|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919886|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
920329|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
919887|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919888|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919889|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919890|NCT01030718|O1|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919891|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919892|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Intolerant|Ph+ ALL subjects with intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919893|NCT01030718|O2|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Resistant|Ph+ ALL subjects with resistance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919894|NCT01030718|O1|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL) - Total Cohort|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919945|NCT01029925|O1|Outcome|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
919895|NCT01030718|O3|Outcome|CML-AP/BP - Imatinib Intolerant|Imatinib intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919896|NCT01030718|O2|Outcome|CML-AP/BP - Imatinib Resistant|Imatinib resistant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919897|NCT01030718|O1|Outcome|CML-AP/BP - Total Cohort|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919898|NCT01030718|O3|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Intolerant|Imatinib intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919899|NCT01030718|O2|Outcome|CML - Chronic Phase (CML-CP) - Imatinib Resistant|Imatinib resistant CML-CP disease cohort who had completed the previous study (CA180031) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919900|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP) Total|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031, allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919901|NCT01030718|O3|Outcome|Ph+ Acute Lymphoblastic Leukemia (Ph+ ALL)|Ph+ ALL subjects with resistance or intolerance to past therapy and who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919902|NCT01030718|O2|Outcome|CML - Accelerated Phase and Blast Phase (CML-AP/BP)|Imatinib resistant or intolerant CML-AP/BP disease cohort who had completed the previous study (CA180031/NCT00337454) phase II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919903|NCT01030718|O1|Outcome|CML - Chronic Phase (CML-CP)|Imatinib resistant or intolerant CML-CP disease cohort who had completed the previous study (CA180031/NCT00337454) phase I/II. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031(ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919904|NCT01030718|E1|Reported Event|All Treated Participants|Imatinib resistant or intolerant CML-CP disease cohort, Imatinib resistant or intolerant CML-AP/BP disease cohort, and Ph+ ALL subjects with resistance or intolerance to past therapy. The study drug was administered twice daily (BID). The starting dose level for this trial in each individual participant was the same dose level at the end of CA180031 (ie, 50mg, 70mg or 90mg BID on a continuous daily dosing schedule), allowed to modify within the range of 50 mg twice daily (BID) to 90 mg BID.
919905|NCT01030666|B3|Baseline|Total|Total of all reporting groups
919906|NCT01030666|B2|Baseline|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
919907|NCT01030666|B1|Baseline|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
919908|NCT01030666|P2|Participant Flow|Placebo|The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect
919909|NCT01030666|P1|Participant Flow|Doxycycline|The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects
919910|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
919911|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
919912|NCT01030666|O2|Outcome|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
919913|NCT01030666|O1|Outcome|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects addionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
919914|NCT01030666|E2|Reported Event|Placebo|"The patients of the control group will take placebo once a day for 7 days after regenerative therapy of an infrabony defect additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
919946|NCT01029925|E1|Reported Event|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
919915|NCT01030666|E1|Reported Event|Doxycycline|"The patients of the doxycycline group will take 200 mg doxycycline once a day for 7 days after regenerative therapy of an infrabony defects additionally to~modified/simplified papilla preservation flap; scaling~Prefgel/Emdogain~0.12% chlorhexidine gluconate solution~Ibuprofen 400 mg (if necessary)~1% chlorhexidine gluconate gel (if necessary)"
919916|NCT01030653|B3|Baseline|Total|Total of all reporting groups
919917|NCT01030653|B2|Baseline|Voriconazole Low Dose First Then High Dose|
919918|NCT01030653|B1|Baseline|Voriconazole High Dose First Then Low Dose|Both voriconazole arms are shown as a single group because the same individuals received both arms of the intervention in a cross-over design.
919919|NCT01030653|P2|Participant Flow|Voriconazole Low Dose First Then High Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses)
919920|NCT01030653|P1|Participant Flow|Voriconazole High Dose First Then Low Dose|Active: Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Two Fixed Maintenance Doses ( 300 mg Every 12 Hours x 7 Doses) followed by a 7-day washout period then a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses ( 200 mg Every 12 Hours x 7 Doses)
919921|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
919922|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
919923|NCT01030653|O1|Outcome|Voriconazole High : Low Dose|"Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)~Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)"
919924|NCT01030653|O2|Outcome|Voriconazole Higher Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
919925|NCT01030653|O1|Outcome|Voriconazole Lower Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
919926|NCT01030653|E2|Reported Event|Voriconazole Low Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (200 mg or Every 12 Hours x 7 Doses)
919927|NCT01030653|E1|Reported Event|Voriconazole High Dose|Voriconazole Administered by Mouth as a Loading Dose (400 mg x 2 Doses, Day 1) and as Maintenance Doses (300 mg or Every 12 Hours x 7 Doses)
919928|NCT01030458|B3|Baseline|Total|Total of all reporting groups
919929|NCT01030458|B2|Baseline|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
919931|NCT01030458|P2|Participant Flow|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg and to achieve blood pressure control, the study medication could be up-titrated to 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
919932|NCT01030458|P1|Participant Flow|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and to achieve blood pressure control, the study medication could be up-titrated to amlodipine 10 mg plus 160 mg valsartan. Patients take the study medication once a day, in the morning. Follow-up visits will take place at 2 weeks, 1 month and every month thereafter, up until 6 months.
919933|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
919934|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
919935|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
919936|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
919937|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
919938|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
919939|NCT01030458|O2|Outcome|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
919940|NCT01030458|O1|Outcome|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
919941|NCT01030458|E2|Reported Event|Hydrochlorothiazide Plus Bisoprolol|In the reference group, the Lodoz will be used in two dosage steps, respectively 6.25 mg hydrochlorothiazide plus 5 mg or 6.25 mg hydrochlorothiazide plus 10 mg bisoprolol
919942|NCT01030458|E1|Reported Event|Amlodipine Plus Valsartan|In the experimental group, Exforge will be used in two dosage steps, respectively, amlodipine 5 mg plus 160 mg valsartan and amlodipine 10 mg plus 160 mg valsartan.
919943|NCT01029925|B1|Baseline|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
919944|NCT01029925|P1|Participant Flow|Dichloroacetate (DCA)|Dichloroacetate, 6.25mg/kg orally, twice daily, administered with food around the same time every day and at approximately 8-12 hours apart.
919952|NCT01029886|O4|Outcome|Liraglutide Once Daily Without SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and without SU use at screening
919953|NCT01029886|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection, 2mg, once weekly and without SU use at screening
919954|NCT01029886|O2|Outcome|Liraglutide Once Daily With SU Use at Screening|Subcutaneous injection, forced titration to 1.8mg, once daily and with SU use at screening
919955|NCT01029886|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection, 2mg, once weekly and with SU use at screening
919956|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919957|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919958|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919959|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919960|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919961|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919962|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919963|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919964|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919965|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919966|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919967|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919968|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919969|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919970|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919971|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919972|NCT01029886|O2|Outcome|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919973|NCT01029886|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919974|NCT01029886|E2|Reported Event|Liraglutide Once Daily|Subcutaneous injection, forced titration to 1.8mg, once daily
919975|NCT01029886|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2mg, once weekly
919976|NCT01029795|B3|Baseline|Total|Total of all reporting groups
919977|NCT01029795|B2|Baseline|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920330|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
919978|NCT01029795|B1|Baseline|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919979|NCT01029795|P2|Participant Flow|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919980|NCT01029795|P1|Participant Flow|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919981|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919982|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919983|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919984|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919985|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919986|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919987|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920059|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
920060|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
919988|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919989|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919990|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919991|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919992|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919993|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919994|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919995|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919996|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920281|NCT01028053|O1|Outcome|Not Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to not clinically probable Alzheimer’s Disease (pAD).
919997|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
919998|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
919999|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920000|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920001|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920002|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920003|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920004|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920005|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920006|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920007|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920061|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
920062|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
920008|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920009|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920010|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920011|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920012|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920013|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920014|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920015|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920016|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920017|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920018|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920019|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920020|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920021|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920022|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920023|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920024|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920025|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920026|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920027|NCT01029795|O2|Outcome|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920063|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
920064|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
920028|NCT01029795|O1|Outcome|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920029|NCT01029795|E2|Reported Event|Glyburide|Participants received up to 4 capsules po BID in combinations of 2.5-mg capsules of Glyburide or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) Glyburide was administered, based on predefined glycemic targets, in escalating doses from 5 mg/day up to 20 mg/day.
920030|NCT01029795|E1|Reported Event|LY2599506|Participants received up to 4 capsules by mouth (po), twice daily (BID), in combinations of 50 milligram (mg) or 100 mg capsules of LY2599506 or matching placebo capsules. (Each dose contained at least 1 capsule of active drug.) LY2599506 was administered, based on predefined glycemic targets, in escalating doses from 100 mg/day up to 800 mg/day.
920031|NCT01029730|B1|Baseline|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
920032|NCT01029730|P1|Participant Flow|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
920033|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
920160|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
925130|NCT01015703|O1|Outcome|1 mg Dose|1 mg CoVaccine HT
920034|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
920035|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
920036|NCT01029730|O1|Outcome|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
920037|NCT01029730|E1|Reported Event|Bendamustine/Bortezomib/Rituximab|"Treatment for all patients will be given in cycles of 28 days (4 weeks). All patients will receive treatment with bendamustine, bortezomib, and rituximab for a maximum of 6 cycles. Rituximab should be administered first.~Bendamustine: Bendamustine: 90 mg/m2 Days 1 and 2 of 6, 28-day cycles~Bortezomib: Bortezomib: 1.6 mg/m2 given IV on Day 1, Day 8, and Day 15 of 6, 28-day cycles~Rituximab: Rituximab, Cycle 1: 375 mg/m2 given IV on Day 1, Day 8, and Day 15 Rituximab, Cycles 2-6: 375 mg/m2 given IV on Day 1"
920038|NCT01029704|B6|Baseline|Total|Total of all reporting groups
920039|NCT01029704|B5|Baseline|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
920040|NCT01029704|B4|Baseline|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
920041|NCT01029704|B3|Baseline|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
920042|NCT01029704|B2|Baseline|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
920043|NCT01029704|B1|Baseline|Placebo|Received no drug (EGT0001442) during 28 days
920044|NCT01029704|P5|Participant Flow|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
920045|NCT01029704|P4|Participant Flow|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
920046|NCT01029704|P3|Participant Flow|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
920047|NCT01029704|P2|Participant Flow|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
920048|NCT01029704|P1|Participant Flow|Placebo|Received no drug (EGT0001442) during 28 days
920049|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
920050|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
920051|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
920052|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
920053|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
920054|NCT01029704|O5|Outcome|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
920055|NCT01029704|O4|Outcome|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
920056|NCT01029704|O3|Outcome|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
920057|NCT01029704|O2|Outcome|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
920058|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
920068|NCT01029704|O1|Outcome|Placebo|Received no drug (EGT0001442) during 28 days
920069|NCT01029704|E5|Reported Event|EGT0001442 50mg|Received 50mg of EGT0001442 per day for 28 days
920070|NCT01029704|E4|Reported Event|EGT0001442 20mg|Received 20mg of EGT0001442 per day for 28 days
920071|NCT01029704|E3|Reported Event|EGT0001442 10mg|Received 10mg of EGT0001442 per day for 28 days
920072|NCT01029704|E2|Reported Event|EGT0001442 5mg|Received 5mg of EGT0001442 per day for 28 days
920073|NCT01029704|E1|Reported Event|Placebo|Received no drug (EGT0001442) during 28 days
920074|NCT01029652|B3|Baseline|Total|Total of all reporting groups
920075|NCT01029652|B2|Baseline|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920076|NCT01029652|B1|Baseline|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920077|NCT01029652|P2|Participant Flow|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. No patient received triamcinolone acetonide in second extension Study ."
920315|NCT01028014|P1|Participant Flow|Pseudoephedrine 120mg ER Daily|120 mg extended release tablet one daily for 14 days
920078|NCT01029652|P1|Participant Flow|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study"
920079|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920080|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920081|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920082|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920128|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920199|NCT01029392|B1|Baseline|Those Requiring Vit D Supplement|"Those who had a Vit D level of < 30~Vitamin D: 2000iu once a day"
920083|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920084|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920085|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920183|NCT01029405|B2|Baseline|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920086|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920087|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920088|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920089|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920090|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920091|NCT01029652|O6|Outcome|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
920092|NCT01029652|O5|Outcome|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
920200|NCT01029392|P2|Participant Flow|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
920201|NCT01029392|P1|Participant Flow|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL~Vitamin D: 2000 IU once a day"
920093|NCT01029652|O4|Outcome|Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
920094|NCT01029652|O3|Outcome|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
920095|NCT01029652|O2|Outcome|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
920096|NCT01029652|O1|Outcome|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920097|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920098|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920099|NCT01029652|O2|Outcome|Randomized to Triamcinolone and Switched to Canakinumab|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920100|NCT01029652|O1|Outcome|Randomized to Canakinumab and Re-treated With Canakinumab|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920101|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. Note that flare rate was calculated using only those new flares before switching."
920102|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920103|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study. Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period
920104|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920105|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920106|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920161|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920107|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920108|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920109|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920110|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920111|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920112|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920113|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920114|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920115|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period"
920202|NCT01029392|O2|Outcome|No Vitamin D Supplementation|Screening vitamin D level in normal range for children (50-80 ng.mL)
951217|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
920116|NCT01029652|O1|Outcome|Canakinumab 150 mg|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920117|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920118|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920119|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920120|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920121|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920122|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920123|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920124|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920125|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920126|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920127|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920175|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920129|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920130|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920131|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920316|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
920317|NCT01028014|O5|Outcome|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
920132|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920133|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920134|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920135|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920136|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920137|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920138|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920139|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920140|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920141|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
951218|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
920142|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920143|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920144|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920145|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920146|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920147|NCT01029652|O2|Outcome|Triamcinolone Acetonide 40 mg|Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920148|NCT01029652|O1|Outcome|Canakinumab 150 mg|Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.
920149|NCT01029652|E6|Reported Event|Randomized to Triam: After Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event after switched to canakinumab
920150|NCT01029652|E5|Reported Event|Randomized to Triam: Before Switched to Canakinumab|All patients who were randomized to triamcinolone acetonide (Triam) received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1, experienced adverse event before switched to canakinumab
920151|NCT01029652|E4|Reported Event|All Randomized to Triamcinolone Acetonide (Triam)|"Patients received 1 intramuscular (im) injection of triamcinolone acetonide 40 mg and 1 subcutaneous (sc) injection of placebo to canakinumab on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 week extension study for any new gout flare on demand with the same treatment as assigned in the core study.~Patients under this arm who agreed to continue to 2nd extension period of 12 months, were switched to canakinumab 150 mg sc for any new gout flare during this period. AE/SAE were only assigned to this group before being switched to canakinumab"
920152|NCT01029652|E3|Reported Event|Randomized to Canakinumab :After Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events after re-treated with canakinumab
920153|NCT01029652|E2|Reported Event|Randomized to Canakinumab :Before Re-treated With Canakinumab|All patients who were randomized to Canakinumab in core study period received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1 but experienced adverse events before re-treated with canakinumab
920154|NCT01029652|E1|Reported Event|All Randomized to Canakinumab|"Patients received 1 subcutaneous (sc) injection of canakinumab 150 mg and 1 intramuscular (im) injection of placebo to triamcinolone acetonide on Day 1. Patients could receive a re-dose of study drug on demand upon the occurrence of new flares, but re-dosing could not occur until 14 days had elapsed after the previous dose. Patients completing the 12 weeks core study were allowed to continue to be treated in another 12 weeks extension study for any new gout flare on demand with the same treatment as assigned in the core study.~After completing the first extension study, patients were offered to enter the second extension study, whereby all patients were treated open-label on demand with canakinumab 150 mg sc upon new flare for 1 year for a total duration of 18 months following randomization in the core study."
920155|NCT01029535|B1|Baseline|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920156|NCT01029535|P1|Participant Flow|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920157|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920158|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920159|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920318|NCT01028014|O4|Outcome|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
920162|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920163|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920164|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920165|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920166|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920167|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920168|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920169|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920170|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920171|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920172|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920173|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920174|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920198|NCT01029392|B2|Baseline|No Vit D Supplementation|Normal vitamin D levels No Vitamin D supplement
920176|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920177|NCT01029535|O1|Outcome|Juvederm® VOLUMA™|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920178|NCT01029535|E2|Reported Event|Juvederm® VOLUMA™_Phase 2|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920179|NCT01029535|E1|Reported Event|Juvederm® VOLUMA™_Phase 1|Juvederm® VOLUMA™ injected in both sides of face (up to 4 mL per side) at Investigator's discretion to achieve at least a 2-point improvement in the Mid-face Volume Deficit Scale. Participants who completed Week 8 of Phase 1 were eligible to participate in Phase 2 and could receive an additional optional treatment if applicable.
920180|NCT01029405|B5|Baseline|Total|Total of all reporting groups
920181|NCT01029405|B4|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920182|NCT01029405|B3|Baseline|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920184|NCT01029405|B1|Baseline|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920185|NCT01029405|P4|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920186|NCT01029405|P3|Participant Flow|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920187|NCT01029405|P2|Participant Flow|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920188|NCT01029405|P1|Participant Flow|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent (%) and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920189|NCT01029405|O3|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920190|NCT01029405|O2|Outcome|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920191|NCT01029405|O1|Outcome|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920192|NCT01029405|O1|Outcome|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920193|NCT01029405|E4|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Twice Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920194|NCT01029405|E3|Reported Event|AN2728 Ointment B 2 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 2 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920195|NCT01029405|E2|Reported Event|AN2728 Ointment B 0.5 Percent +Ointment B Vehicle, Twice Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, twice daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920196|NCT01029405|E1|Reported Event|AN2728 Ointment B 0.5 Percent + Ointment B Vehicle, Once Daily|AN2728 ointment B 0.5 percent and ointment B vehicle was applied to 2 comparable and anatomically distinct treatment-targeted plaques respectively within each participant, once daily for 12 weeks. Plaques were identified at Baseline (Day 1) by investigator.
920197|NCT01029392|B3|Baseline|Total|Total of all reporting groups
920203|NCT01029392|O1|Outcome|Vitamin D Supplement|"Those who had a Vit D level of < 30 ng/mKL~Vitamin D: 2000 IU once a day"
920204|NCT01029392|O2|Outcome|No Vitamin D Supplementation|Those with normal vitamin D levels (50-80 ng/mL) No vitamin D supplemenation
920205|NCT01029392|O1|Outcome|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 Vitamin D: 2000iu once a day
920206|NCT01029392|E2|Reported Event|No Vit D Supplementation|Normal vitamin D levels (50-80 ng/mL) No vitamin D supplementation
920207|NCT01029392|E1|Reported Event|Those Requiring Vit D Supplement|Those who had a Vit D level of < 30 ng/mL Vitamin D: 2000iu once a day
920208|NCT01029366|B3|Baseline|Total|Total of all reporting groups
920209|NCT01029366|B2|Baseline|ALL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
920210|NCT01029366|B1|Baseline|CLL Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy
920211|NCT01029366|P2|Participant Flow|Acute Lymphocytic Leukemia (ALL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹
920232|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
920319|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
920212|NCT01029366|P1|Participant Flow|Chronic Lymphocytic Leukemia (CLL) Subjects|Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis polymerase chain reaction reverse transcriptase-polymerase chain reaction anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV genetically engineered lymphocyte therapy. Subjects were given minimum/maximum total dose: 1.5x10⁷/ 5x10⁹.
920213|NCT01029366|O2|Outcome|ALL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity~laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
920214|NCT01029366|O1|Outcome|CLL Subjects|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity~laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
920215|NCT01029366|O1|Outcome|All Participants|"Patients receive CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:41BB administered on days 0, 1, 2 and 11 in the absence of disease progression or unacceptable toxicity laboratory biomarker analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~anti-CD19-CAR retroviral vector-transduced autologous T cells: Given IV~genetically engineered lymphocyte therapy"
920216|NCT01029366|E2|Reported Event|Acute Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
920217|NCT01029366|E1|Reported Event|Chronic Lymphocytic Leukemia|CART-19 (autologous T cells transduced with CD19 TCR-ζ/4-1BB vector) administered as an IV infusion. Minimum/maximum total dose: 1.5x10^7 / 5x10^9.
920218|NCT01029340|B6|Baseline|Total|Total of all reporting groups
920219|NCT01029340|B5|Baseline|Arm 5: Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
920220|NCT01029340|B4|Baseline|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia for 6 months
920221|NCT01029340|B3|Baseline|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted to Label Potency for 6 months
920222|NCT01029340|B2|Baseline|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
920223|NCT01029340|B1|Baseline|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
920224|NCT01029340|P6|Participant Flow|Arm 6: Recombinant Factor VIII (BAY81-8973) Part B + Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
920225|NCT01029340|P5|Participant Flow|Arm 5: Recombinant Factor VIII by CS/EP|Part C - Arm 5: Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
920272|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
920226|NCT01029340|P4|Participant Flow|Arm 4: Recombinant Factor VIII by CS/ADJ Then by CS/EP|Part B - Arm 4:. Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay Per European Pharmacopeia (CS/EP) for 6 months
920227|NCT01029340|P3|Participant Flow|Arm 3: Recombinant Factor VIII by CS/EP Then by CS/ADJ|Part B - Arm 3: Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and then crossed over to study drug measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
920228|NCT01029340|P2|Participant Flow|Arm 2: Kogenate FS Then Recombinant Factor VIII (BAY81-8973)|Part A - Arm 2: Participants first received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg, then 1 single IV injection of BAY81-8973 50 IU/kg with a wash-out period of at least 2-3 days in between
920229|NCT01029340|P1|Participant Flow|Arm 1: Recombinant Factor VIII (BAY81-8973) Then Kogenate FS|Part A - Arm 1: Participants first received one single intravenous (IV) injection of BAY81-8973 50 IU/kg, then 1 single IV injection of Kogenate FS (BAY14-2222) 50 IU/kg with a wash-out period of at least 2-3 days in between
920230|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
920231|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
920320|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
920233|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
920234|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
920235|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
920236|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
920237|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
920238|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants received a loading dose of approximately 50 IU/kg of BAY81-8973 before the first surgical incision, followed by further treatment with BAY81-8973 according to surgical requirements for up to 3 weeks
920239|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
920240|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) and Kogenate FS - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg and one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
920241|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
920242|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
920243|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
920244|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
920245|NCT01029340|O2|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/ADJ - Part B|Participants received IV injection of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay/Adjusted (CS/ADJ) to Label Potency for 6 months
920246|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
920247|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months
920273|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
920248|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part B|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and by Chromogenic Substrate Assay/Adjusted to Label Potency (CS/ADJ) for 6 months, sequence according to randomization.
920249|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
920250|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
920251|NCT01029340|O2|Outcome|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
920252|NCT01029340|O1|Outcome|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
920253|NCT01029340|E4|Reported Event|Recombinant Factor VIII (BAY81-8973) by CS/EP - Part C|Participants in Part C received a loading dose of approximately 50 IU/kg of BAY81-8973 (nearest whole vial amount) for less than 15 minutes before the first surgical incision. Then they received further treatment with BAY81-8973 according to surgical requirements up to 3 weeks.
920254|NCT01029340|E3|Reported Event|Recombinant Factor VIII (BAY81-8973) Part B and Extension|Participants received IV injections of BAY81-8973 at 20-50 IU/kg 2-3 times per week with BAY81-8973 measured by Chromogenic Substrate Assay Potency Per European Pharmacopeia (CS/EP) for 6 months and CS/ADJ for 6 months sequence according to randomization and up to 12 months (CS/EP) during extension
920255|NCT01029340|E2|Reported Event|Kogenate FS (BAY14-2222) - Part A|Participants received one single intravenous (IV) injection of Kogenate FS (BAY14-2222) 50 IU/kg
920256|NCT01029340|E1|Reported Event|Recombinant Factor VIII (BAY81-8973) - Part A|Participants received one single intravenous (IV) injection of BAY81-8973 50 IU/kg
920257|NCT01028131|B5|Baseline|Total|Total of all reporting groups
920258|NCT01028131|B4|Baseline|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
920259|NCT01028131|B3|Baseline|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples - cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
920260|NCT01028131|B2|Baseline|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
920261|NCT01028131|B1|Baseline|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
920262|NCT01028131|P4|Participant Flow|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
920263|NCT01028131|P3|Participant Flow|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples(looking for clean samples with cotinine less than 100 ng/ml) at prenatal visits. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
920264|NCT01028131|P2|Participant Flow|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
920265|NCT01028131|P1|Participant Flow|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
920266|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
920267|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
920268|NCT01028131|O2|Outcome|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
920269|NCT01028131|O1|Outcome|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
920270|NCT01028131|O4|Outcome|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
920271|NCT01028131|O3|Outcome|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits (looking for clean samples -cotinine less than 100 ng/ml). Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
921225|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
920274|NCT01028131|E4|Reported Event|Combined Brief Intervention and CM|Combined intervention. Participants in this condition will receive both the brief intervention and the brief description of the CM process.
920275|NCT01028131|E3|Reported Event|Contingency Management Alone|Participants randomized by the computer into this condition will view a 20-minute music and tv video clip after completing the brief assessment. The research assistant will then briefly describe the CM process, with some time to discuss questions regarding procedure to assure understanding. The CM condition will involve participant-initiated submission of urine samples at prenatal visits. Clean samples (cotinine less than 100 ng/ml) will result in the immediate provision of a $50 Target gift card. Clinic staff will have no responsibility for the CM component other than calling research staff when a participant wishes to submit a sample. Clinic staff will not schedule any new, additional, or unnecessary prenatal visits.
920276|NCT01028131|E2|Reported Event|Computerized Brief Intervention (5As)|After completing the brief assessment battery, participants will interact with the computer for approximately 20 minutes, with structure being based on the Five A model and Motivational Interviewing.
920277|NCT01028131|E1|Reported Event|Control|Participants randomized by the computer into this condition will only view the 20-minute video clips of music and tv videos.
920278|NCT01028053|B1|Baseline|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
920279|NCT01028053|P1|Participant Flow|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
920280|NCT01028053|O2|Outcome|Clinically Probable Alzheimer’s Disease|A blinded visual interpretation of a clinical diagnosis of the number of Normal-Scan and Abnormal-Scan Subjects who Converted to clinically probable Alzheimer’s Disease (pAD).
920321|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
920322|NCT01028014|O6|Outcome|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
920282|NCT01028053|O1|Outcome|Hazard Ratio|"The statistic Hazard ratio (HR) is the ratio of the hazard rates in the 2 groups (1 group being normal (negative for amyloid B) and 1 group being abnormal (positive for amyloid B). Under the null hypothesis of equal rates, the HR would be equal to 1.~As the HR increases above 1, the chances of being probable Alzheimer’s Disease (pAD) also increases."
920283|NCT01028053|E1|Reported Event|Flutemetamol (18F) Injection|Flutemetamol (18F) Injection: All subjects will receive an intravenous dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.
920284|NCT01028027|B3|Baseline|Total|Total of all reporting groups
920285|NCT01028027|B2|Baseline|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920286|NCT01028027|B1|Baseline|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920287|NCT01028027|P2|Participant Flow|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920288|NCT01028027|P1|Participant Flow|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920289|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920290|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920291|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920292|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920293|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920294|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920295|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920296|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920297|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920298|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920704|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
921226|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
920299|NCT01028027|O2|Outcome|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920300|NCT01028027|O1|Outcome|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920301|NCT01028027|E2|Reported Event|Tobramycin and Dexamethasone|Tobramycin 0.3% and dexamethasone 0.1% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920302|NCT01028027|E1|Reported Event|Loteprednol and Tobramycin|Loteprednol etabonate 0.5% and tobramycin 0.3% ophthalmic suspension. Participants will instill one or two drops of study drug topically in the affected eye(s), at approximately four hour intervals, QID, for 14 days.
920303|NCT01028014|B7|Baseline|Total|Total of all reporting groups
920304|NCT01028014|B6|Baseline|Lactose Capsules, One Daily|sham lactose capsules, 1 daily for 14 days
920305|NCT01028014|B5|Baseline|Cyclobenzaprine 10mg Daily|10 mg tablet, 1 daily for 14 days
920306|NCT01028014|B4|Baseline|Imipramine 25mg Daily|25 mg tablet, 1 daily for 14 days
920307|NCT01028014|B3|Baseline|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
920308|NCT01028014|B2|Baseline|Solifenacin 5mg Daily|5 mg capsule, 1 daily for 14 days
920309|NCT01028014|B1|Baseline|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 daily for 14 days
920310|NCT01028014|P6|Participant Flow|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
920311|NCT01028014|P5|Participant Flow|Cyclobenzaprine 10mg Daily|10 mg tablet, one daily for 14 days
920312|NCT01028014|P4|Participant Flow|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
920313|NCT01028014|P3|Participant Flow|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
920314|NCT01028014|P2|Participant Flow|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
920331|NCT01028014|O3|Outcome|Tamsulosin 0.4mg Daily|0.4 mg capsule, 1 daily for 14 days
920332|NCT01028014|O2|Outcome|Solifenacin 5mg Daily|5 mg capsule, 1 capsule daily for 14 days
920333|NCT01028014|O1|Outcome|Pseudoephedrine 120mg ER Daily|120 mg extended release, 1 tablet daily for 14 days
920334|NCT01028014|E6|Reported Event|Lactose Capsules, One Daily|sham lactose capsules, one daily for 14 days
920335|NCT01028014|E5|Reported Event|Cyclobenzaprine 10mg Daily|10mg tablet, one daily for 14 days
920336|NCT01028014|E4|Reported Event|Imipramine 25mg Daily|25 mg tablet, one daily for 14 days
920337|NCT01028014|E3|Reported Event|Tamsulosin 0.4mg Daily|0.4 mg capsule, one daily for 14 days
920338|NCT01028014|E2|Reported Event|Solifenacin 5mg Daily|5 mg capsule, one daily for 14 days
920339|NCT01028014|E1|Reported Event|Pseudoephedrine 120mg ER Daily|120mg extended release, one daily for 14 days
920340|NCT01029262|B3|Baseline|Total|Total of all reporting groups
920341|NCT01029262|B2|Baseline|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920342|NCT01029262|B1|Baseline|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920343|NCT01029262|P2|Participant Flow|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920344|NCT01029262|P1|Participant Flow|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920345|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920346|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920492|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920347|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920348|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920349|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920350|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920351|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920352|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920353|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920354|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920355|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920356|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920357|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920358|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920359|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920360|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920408|NCT01028911|B2|Baseline|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
925131|NCT01015703|E5|Reported Event|10 mg Dose|10 mg CoVaccine HT
920361|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920362|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920363|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920364|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920365|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920366|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920367|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920368|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920369|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920370|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920371|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920372|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects or withdrawal of consent.
920373|NCT01029262|O2|Outcome|Lenalidomide|".Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920374|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920375|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920376|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920377|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920378|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920379|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance between 40 and 60 mL/min."
920380|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred or intolerable side effects.
920381|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920382|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920383|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920384|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920385|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920386|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920387|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920388|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920389|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920390|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920391|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920392|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920393|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920394|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920395|NCT01029262|O2|Outcome|Lenalidomide|"Lenalidomide 10 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression, intolerable side effects or withdrawal of consent.~Lenalidomide 5 mg PO daily plus 2 placebo capsules for participants with a creatinine clearance ≥ 40 and < 60 mL/min."
920396|NCT01029262|O1|Outcome|Placebo|3 placebo capsules by mouth (PO) daily (QD) for at least 168 days until disease progression occurred, intolerable side effects or withdrawal of consent.
920397|NCT01029262|E2|Reported Event|Lenalidomide|Lenalidomide 10 mg daily (QD) by mouth (PO) + 2 placebo capsules for participants with a creatinine clearance ≥ 60 mL/min for at least 168 days until disease progression or intolerable side effects. Or 5 mg Lenalidomide capsule + 2 placebo capsules PO QD for participants with a creatinine clearance between 40 and 60 mL/min.
920398|NCT01029262|E1|Reported Event|Placebo|3 placebo capsules PO QD for at least 168 days unless disease progression or intolerable side effects.
951219|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
920399|NCT01029054|B1|Baseline|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920400|NCT01029054|P3|Participant Flow|Dose Escalation Cohort 3|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 36 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920401|NCT01029054|P2|Participant Flow|Dose Escalation Cohort 2|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 27 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920402|NCT01029054|P1|Participant Flow|Dose Escalation Cohort 1|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance) at dose level 20 mg/m^2.~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920403|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920404|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920405|NCT01029054|O1|Outcome|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920406|NCT01029054|E1|Reported Event|Carfilzomib, Lenalidomide w/Dexamethasone|"Carfilzomib will be administered as an IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for Cycles 1 - 8 (induction) and on Days 1, 2, 15, and 16 of a 28-day cycle for Cycles 9+ (maintenance).~Lenalidomide will be administered PO daily at 25 mg on Days 1- 21 of the 28-day cycle for Cycles 1 - 8+.~Dexamethasone will be administered PO or IV between 30 minutes and 4 hours preceding the carfilzomib push."
920407|NCT01028911|B3|Baseline|Total|Total of all reporting groups
920409|NCT01028911|B1|Baseline|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920410|NCT01028911|P2|Participant Flow|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920411|NCT01028911|P1|Participant Flow|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920412|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920413|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920414|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920415|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920416|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920417|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920418|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920419|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920420|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920421|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920422|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920423|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920424|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920425|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920559|NCT01028222|B1|Baseline|Nilotinib|400 mg twice daily
920426|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920427|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920428|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920429|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920430|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920431|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920432|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920433|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
921227|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
920434|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920435|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920436|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920437|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920438|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920439|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920440|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920441|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920442|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920443|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920560|NCT01028222|P2|Participant Flow|DTIC|850 mg/m2 IV every 3 weeks
920444|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920445|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920446|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920447|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920448|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920449|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920450|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920451|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920637|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
920452|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920453|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920454|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920455|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920456|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920457|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920458|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920459|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920460|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920461|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920462|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920463|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920464|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920465|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920466|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920467|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920468|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920469|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920700|NCT01027598|B1|Baseline|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
951220|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
920470|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920471|NCT01028911|O2|Outcome|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920472|NCT01028911|O1|Outcome|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920473|NCT01028911|E2|Reported Event|Placebo and Donepezil|Placebo matched to PF-03654746 powder in capsule once daily on Day 1 to 30 along with background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920474|NCT01028911|E1|Reported Event|PF-03654746 and Donepezil|PF-03654746 0.25 milligram (mg) powder in capsule orally once daily on Day 1 to 5, followed by PF-03654746 0.5 mg powder in capsule orally once daily on Day 6 to 10 and PF-03654746 1 mg powder in capsule orally once daily on Day 11 to 15 during the forced titration phase. PF-03654746 0.5 mg to 2 mg powder in capsule orally once daily, based on investigator’s discretion and tolerability, on Day 16 to 30 during the flexible titration phase. Background donepezil (Aricept) 10 mg tablet orally once daily throughout the study.
920475|NCT01028820|B1|Baseline|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
920476|NCT01028820|P1|Participant Flow|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
920477|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
920478|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
920479|NCT01028820|O2|Outcome|Open-Label, Flexible-Dose Aripiprazole: 8 Weeks (Post-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
920480|NCT01028820|O1|Outcome|Open-Label, Flexible-Dose Aripiprazole: Baseline (Pre-Dose)|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
920481|NCT01028820|E1|Reported Event|Open-Label, Flexible-Dose Aripiprazole|"This is a single group assignment pharmacodynamics study in which all study participants are given an open-label, flexible dose of aripiprazole for up to 8 weeks.~Aripiprazole : 8 weeks, starting dosage 5mg titrating up 5mg every week as needed to maximum dosage of 25mg daily"
920482|NCT01028677|B3|Baseline|Total|Total of all reporting groups
920483|NCT01028677|B2|Baseline|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920484|NCT01028677|B1|Baseline|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920485|NCT01028677|P2|Participant Flow|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations (0.1 metered dose/insufflation) twice daily for 6 weeks"
920486|NCT01028677|P1|Participant Flow|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920487|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920488|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920489|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920490|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920491|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920701|NCT01027598|P2|Participant Flow|Erlotinib + Placebo|"Erlotinib: 150 mg orally daily~Placebo: orally daily"
951221|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
920493|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920494|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920495|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920496|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920497|NCT01028677|O2|Outcome|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920498|NCT01028677|O1|Outcome|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920499|NCT01028677|E2|Reported Event|Intranasal Spray Without Oxytocin|"Twice daily intranasal spray without oxytocin (six 0.1 ml insufflations/dose) for 6 weeks.~nasal spray without oxytocin: 6 insufflations of nasal spray without oxytocin (0.1 metered dose/insufflation) twice daily for 6 weeks"
920500|NCT01028677|E1|Reported Event|Intranasal Spray With Oxytocin|"Twice daily intranasal oxytocin spray (24 IU, 6 insufflations/dose) for 6 weeks~intranasal spray with oxytocin: 6 insufflations (24 IU of oxytocin total) given twice daily for 6 weeks"
920501|NCT01028651|B1|Baseline|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920502|NCT01028651|P1|Participant Flow|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920503|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920504|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920505|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920506|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920507|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920508|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920509|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920510|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920511|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920512|NCT01028651|O2|Outcome|Treprostinil Injection-Baseline to Week 24|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920513|NCT01028651|O1|Outcome|Treprostinil Injection-Baseline to Week 12|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920514|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920515|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920516|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920517|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920518|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920519|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920520|NCT01028651|O1|Outcome|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920521|NCT01028651|E1|Reported Event|Treprostinil Injection|Subjects meeting inclusion/exclusion criteria with portopulmonary hypertension (PoPH) and severe pulmonary arterial hypertension (PAH).
920522|NCT01028391|B3|Baseline|Total|Total of all reporting groups
920523|NCT01028391|B2|Baseline|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
920702|NCT01027598|P1|Participant Flow|Erlotinib + Pazopanib|"Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
951222|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
920524|NCT01028391|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
920525|NCT01028391|P2|Participant Flow|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
920526|NCT01028391|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
920527|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
920528|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
920529|NCT01028391|O2|Outcome|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
920530|NCT01028391|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
920531|NCT01028391|E2|Reported Event|Pioglitazone 45 mg q.d.|The Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to entering the extension study), these patients received once-daily coadministered treatment with oral tablets of placebo to sitagliptin 100 mg and pioglitazone 30 mg.
920532|NCT01028391|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 45 mg q.d. (q.d. = once daily) group includes extension study data from patients who received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 45 mg. During the 24-week base study (prior to the entering the extension study), these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and pioglitazone 30 mg.
920533|NCT01028378|B1|Baseline|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920534|NCT01028378|P1|Participant Flow|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920535|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920536|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920537|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920538|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920539|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920540|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920541|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920542|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920543|NCT01028378|O1|Outcome|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920544|NCT01028378|E1|Reported Event|Topography-guided LASIK|"Topography-guided LASIK for Myopia or Hyperopia~T-CAT topography-guided LASIK treatment with the Allegretto Wave Eye-Q 400 Hz Excimer Laser"
920545|NCT01028352|B1|Baseline|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
920546|NCT01028352|P1|Participant Flow|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
920547|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
920548|NCT01028352|O1|Outcome|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
920549|NCT01028352|E1|Reported Event|Duloxetine|Participants took 30 mg oral capsules once a day for 7 days, then 60 mg per mouth once per day for 21 days. After 4 weeks if pain had decreased, subjects continued 60 mg. per mouth once per day for 4 weeks. If pain had not decreased, subjects took 60 mg twice per day per mouth for 4 weeks. 5 Questionnaires were administered at baseline and every 2 weeks for 8 weeks; medication was tapered at the end of study.
920550|NCT01028300|B1|Baseline|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
920551|NCT01028300|P1|Participant Flow|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
920552|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
920553|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
920554|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
920555|NCT01028300|O1|Outcome|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
920556|NCT01028300|E1|Reported Event|ProDisc L|ProDisc™-L Total Disc Replacement (TDR): The design is based on a ball and socket articulation, one surface being metal and the other an ultra-high molecular weight polyethylene (UHMWPE). Three components comprise this modular prosthesis.
920557|NCT01028222|B3|Baseline|Total|Total of all reporting groups
920558|NCT01028222|B2|Baseline|DTIC|850 mg/m2 IV every 3 weeks
920578|NCT01028222|E3|Reported Event|Crossover Nilotinib Treatment|Crossover nilotinib treatment
920579|NCT01028222|E2|Reported Event|DTIC|850 mg/m2 IV every 3 weeks
920580|NCT01028222|E1|Reported Event|Nilotinib|400 mg twice daily
920581|NCT01027910|B3|Baseline|Total|Total of all reporting groups
920582|NCT01027910|B2|Baseline|PCI-24781 + Doxorubicin With Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, with (Arm B) mandatory G-CSF support was established.
920583|NCT01027910|B1|Baseline|PCI-24781 + Doxorubicin Without Mandatory GCSF|Study participants were enrolled into two arms. Arm A administered abexinostat and doxorubicin with optional GCSF support. Arm B administered abexinostat and doxorubicin with required GCSF support to all participants. The study uses the standard 3 + 3 phase I dose escalation design. Three cohorts of 3-6 participants were enrolled in each arm and separate inter-cohort dose escalations were performed in up to three cohorts of 3-6 participants enrolled sequentially until the maximum tolerated dose (MTD) of the combination abexinostat with doxorubicin, without (Arm A) mandatory G-CSF support was established.
920703|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
951223|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
920584|NCT01027910|P2|Participant Flow|PCI-24781 + Doxorubicin With Mandatory GCSF|"PCI-24781 + Doxorubicin with mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
920585|NCT01027910|P1|Participant Flow|PCI-24781 + Doxorubicin Without Mandatory GCSF|"PCI-24781 + Doxorubicin without mandatory GCSF~PCI-24781: Capsules taken orally for 5 consecutive days starting on Day 1 of each 3 week cycle~Doxorubicin: Administered intravenously on Day 4 of each 3 week cycle"
920586|NCT01027910|O2|Outcome|Mandatory GCSF|
920587|NCT01027910|O1|Outcome|Optional GCSF|
920588|NCT01027910|O2|Outcome|Mandatory GCSF|
920589|NCT01027910|O1|Outcome|Optional GCSF|
920590|NCT01027910|O2|Outcome|Mandatory GCSF|
920591|NCT01027910|O1|Outcome|Optional GCSF|
920592|NCT01027910|O2|Outcome|PCI-24781 With Mandatory GCSF|
920593|NCT01027910|O1|Outcome|PCI-24781 + Doxorubicin Without Mandatory GCSF|
920594|NCT01027910|E2|Reported Event|PCI-24781+Dox With Mandated GCSF|Patients in this are were mandated treatment with GCSF
920595|NCT01027910|E1|Reported Event|PCI-24781+Dox Without Mandated GCSF|Patients in this arm were not mandated treatment with GCSF
920596|NCT01027897|B1|Baseline|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
920597|NCT01027897|P1|Participant Flow|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
920598|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
920599|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
920600|NCT01027897|O1|Outcome|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
920601|NCT01027897|E1|Reported Event|Doripenem Group|Patients will receive doripenem 1 gm IV over 4 hours X 3 doses for the empiric treatment of an infection
920602|NCT01027884|B3|Baseline|Total|Total of all reporting groups
920603|NCT01027884|B2|Baseline|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
920604|NCT01027884|B1|Baseline|Placebo|Two matching placebo tablets were taken three times a day with meals
920605|NCT01027884|P2|Participant Flow|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
920606|NCT01027884|P1|Participant Flow|Placebo|Two matching placebo tablets were taken three times a day with meals
920607|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
920608|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
920609|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
920610|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
920611|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
920612|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
920613|NCT01027884|O2|Outcome|Idebenone|"Idebenone 900 mg/day~Idebenone: Idebenone (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
920614|NCT01027884|O1|Outcome|Placebo|"Placebo 900 mg/day~Placebo: Placebo (900 mg/day) 2 tabl (150 mg each) x 3 times orally with meals"
920615|NCT01027884|O2|Outcome|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
920616|NCT01027884|O1|Outcome|Placebo|Two matching placebo tablets were taken three times a day with meals
920617|NCT01027884|E2|Reported Event|Idebenone|Two150 mg tablets were taken three times a day with meals (total dose 900 mg daily).
920618|NCT01027884|E1|Reported Event|Placebo|Two matching placebo tablets were taken three times a day with meals
920619|NCT01027819|B3|Baseline|Total|Total of all reporting groups
920620|NCT01027819|B2|Baseline|Fixed Bearing|Mobile bearing vs Fixed bearing
920621|NCT01027819|B1|Baseline|Mobile Bearing|Mobile bearing vs Fixed bearing
920622|NCT01027819|P2|Participant Flow|Fixed Bearing|Mobile bearing vs Fixed bearing
920623|NCT01027819|P1|Participant Flow|Mobile Bearing|Mobile bearing vs Fixed bearing
920624|NCT01027819|O2|Outcome|Fixed Bearing|Mobile bearing vs Fixed bearing
920625|NCT01027819|O1|Outcome|Mobile Bearing|Mobile bearing vs Fixed bearing
920626|NCT01027819|E2|Reported Event|Fixed Bearing|Mobile bearing vs Fixed bearing
920627|NCT01027819|E1|Reported Event|Mobile Bearing|Mobile bearing vs Fixed bearing
920628|NCT01027780|B3|Baseline|Total|Total of all reporting groups
920629|NCT01027780|B2|Baseline|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
920630|NCT01027780|B1|Baseline|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
920631|NCT01027780|P2|Participant Flow|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
920632|NCT01027780|P1|Participant Flow|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
920633|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
920634|NCT01027780|O1|Outcome|Mindfulness Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
920635|NCT01027780|O2|Outcome|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
920636|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
920638|NCT01027780|O1|Outcome|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
920639|NCT01027780|E2|Reported Event|Wait-list Control|Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
920640|NCT01027780|E1|Reported Event|Mindfulness-Based Stress Reduction|Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
920641|NCT01027650|B9|Baseline|Total|Total of all reporting groups
920642|NCT01027650|B8|Baseline|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
920643|NCT01027650|B7|Baseline|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
920644|NCT01027650|B6|Baseline|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
920645|NCT01027650|B5|Baseline|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
920646|NCT01027650|B4|Baseline|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
920647|NCT01027650|B3|Baseline|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
920648|NCT01027650|B2|Baseline|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
920649|NCT01027650|B1|Baseline|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
920650|NCT01027650|P8|Participant Flow|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
920651|NCT01027650|P7|Participant Flow|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
920652|NCT01027650|P6|Participant Flow|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
920653|NCT01027650|P5|Participant Flow|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
920654|NCT01027650|P4|Participant Flow|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
920655|NCT01027650|P3|Participant Flow|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
920656|NCT01027650|P2|Participant Flow|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
920657|NCT01027650|P1|Participant Flow|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
920658|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
920659|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
920660|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
920661|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
920662|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
920663|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
920664|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
920665|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
920666|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
920667|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
920668|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
920669|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
920670|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
920671|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
920672|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
920673|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
920674|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
920675|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
920676|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
920677|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
920678|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
920679|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
920680|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
920681|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
920682|NCT01027650|O4|Outcome|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
920683|NCT01027650|O3|Outcome|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
920684|NCT01027650|O2|Outcome|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
920685|NCT01027650|O1|Outcome|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
920686|NCT01027650|O4|Outcome|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
920687|NCT01027650|O3|Outcome|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
920688|NCT01027650|O2|Outcome|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
920689|NCT01027650|O1|Outcome|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
920690|NCT01027650|E8|Reported Event|Stage 2 Arm 4|Dexamethasone 700 ug intravitreal implant on Day 1.
920691|NCT01027650|E7|Reported Event|Stage 2 Arm 3|AGN208397 intravitreal injection 300 ug on Day 1.
920692|NCT01027650|E6|Reported Event|Stage 2 Arm 2|AGN208397 intravitreal injection 450 ug on Day 1.
920693|NCT01027650|E5|Reported Event|Stage 2 Arm 1|AGN208397 intravitreal injection 600 ug on Day 1.
920694|NCT01027650|E4|Reported Event|Stage 1 Cohort 1|AGN208397 intravitreal injection 75 ug on Day 1.
920695|NCT01027650|E3|Reported Event|Stage 1 Cohort 2|AGN208397 intravitreal injection 300 ug on Day 1.
920696|NCT01027650|E2|Reported Event|Stage 1 Cohort 3|AGN208397 intravitreal injection 600 ug on Day 1.
920697|NCT01027650|E1|Reported Event|Stage 1 Cohort 4|AGN208397 intravitreal injection 900 ug on Day 1.
920698|NCT01027598|B3|Baseline|Total|Total of all reporting groups
920699|NCT01027598|B2|Baseline|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
920705|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
920706|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
920707|NCT01027598|O2|Outcome|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
920708|NCT01027598|O1|Outcome|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
920709|NCT01027598|E2|Reported Event|Arm B|"Erlotinib + Placebo~Erlotinib: 150 mg orally daily~Placebo: orally daily"
920710|NCT01027598|E1|Reported Event|Arm A|"Erlotinib + Pazopanib~Erlotinib: 150 mg orally daily~Pazopanib: 600 mg orally daily"
920711|NCT01027468|B1|Baseline|Group 1|3 year follow-up of intravitreal application of bevacizumab
920712|NCT01027468|P1|Participant Flow|Group 1|3 year follow-up of patients with intravitreal application of bevacizumab
920713|NCT01027468|O1|Outcome|Group 1|3 year follow-up of intravitreal application of bevacizumab
920714|NCT01027468|E1|Reported Event|Group 1|3 year follow-up of intravitreal application of bevacizumab
920715|NCT01027364|B5|Baseline|Total|Total of all reporting groups
920716|NCT01027364|B4|Baseline|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920717|NCT01027364|B3|Baseline|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920718|NCT01027364|B2|Baseline|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920719|NCT01027364|B1|Baseline|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920720|NCT01027364|P4|Participant Flow|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920721|NCT01027364|P3|Participant Flow|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920722|NCT01027364|P2|Participant Flow|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920723|NCT01027364|P1|Participant Flow|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
925132|NCT01015703|E4|Reported Event|7 mg Dose|7 mg CoVaccine HT
920724|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920725|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920726|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920727|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920728|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920729|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920730|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920731|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920732|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920733|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920763|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
921202|NCT01026402|P17|Participant Flow|Part A 100mg BD Soln Cont|Continuous BD dosing
920734|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920735|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920784|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
951224|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
920736|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920737|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920738|NCT01027364|O4|Outcome|Sequential PK Subgroup: rFIXFc Week 52|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920739|NCT01027364|O3|Outcome|Sequential PK Subgroup: rFIXFc Week 26|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920740|NCT01027364|O2|Outcome|Sequential PK Subgroup: rFIXFc Day 1|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920760|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920741|NCT01027364|O1|Outcome|Sequential PK Subgroup: BeneFIX|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant’s baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920742|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920743|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920744|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
921228|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
920745|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920746|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920747|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920748|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920761|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920762|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920749|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920750|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920751|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920785|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
921229|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
920752|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis - Sequential PK Subgroup|"Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling.~All participants in Arm 1 received 50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39."
920753|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920754|NCT01027364|O5|Outcome|Total|All participants from Arms 1-4
920755|NCT01027364|O4|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920756|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920757|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920758|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920759|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920764|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Child and adolescent participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
920765|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
920766|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
920767|NCT01027364|O2|Outcome|Pre-study Regimen: On Demand (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had an on-demand pre-study regimen.
920768|NCT01027364|O1|Outcome|Pre-study Regimen: Prophylaxis (Arms 1 and 2 Pooled)|Participants from the Weekly or Individualized Interval Prophylaxis Arms (Arms 1 or 2) who had a prophylaxis pre-study regimen.
920769|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920770|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
921042|NCT01026909|B1|Baseline|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
920771|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920772|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920773|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920774|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920775|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920776|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920777|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920778|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920779|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920834|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920835|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
921203|NCT01026402|P16|Participant Flow|Part A 70mg BD Soln Cont|Continuous BD dosing
920780|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920781|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920782|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920783|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920786|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920787|NCT01027364|O1|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920788|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920789|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920790|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920791|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920792|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920793|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920836|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920794|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920795|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920796|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920797|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920813|NCT01027351|B5|Baseline|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920798|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920799|NCT01027364|O1|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920800|NCT01027364|O5|Outcome|Arm 4: Perioperative Management|The surgical period and dosing were dependent on the type of surgery the participant underwent. Participants who started the study in one of the other treatment arms prior to surgery returned to the original treatment arm. Participants who joined the study in the Surgery arm were assigned to one of the other treatment arms following post-operative rehabilitation.
920801|NCT01027364|O4|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920802|NCT01027364|O3|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920803|NCT01027364|O2|Outcome|Arm 1: Weekly Prophylaxis-rFIXFc|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920804|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis-BeneFIX|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920805|NCT01027364|O3|Outcome|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920806|NCT01027364|O2|Outcome|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
921204|NCT01026402|P15|Participant Flow|Part B 170mg BD Tab Int|Intermittent BD dosing
920807|NCT01027364|O1|Outcome|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920808|NCT01027364|E3|Reported Event|Arm 3: Episodic (On Demand)|20 to 100 IU/kg rFIXFc via IV injection, or the dose indicated by the participant's baseline PK to target a plasma level of 20% to 100%, as needed for the treatment of mild to severe bleeding episodes
920809|NCT01027364|E2|Reported Event|Arm 2: Individualized Interval Prophylaxis|100 IU/kg rFIXFc via IV injection once every 10 days initially, then at an interval derived from the baseline PK assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial 10-day interval were to be made based on baseline PK assessments and trough levels, which were monitored at Weeks 4, 16, 26, and 39.
920810|NCT01027364|E1|Reported Event|Arm 1: Weekly Prophylaxis|"50 IU/kg rFIXFc via intravenous (IV) injection once every 7 days initially, then at a dose indicated by the participant's baseline pharmacokinetic (PK) assessment that ensured a target trough of 1% to 3% above baseline or higher, as clinically indicated. Adjustments to the initial weekly dose of rFIXFc (50 IU/kg) were to be made based on baseline PK assessments, occurrence of spontaneous bleeding episodes, and the trough levels, which were to be monitored at Weeks 4, 16, 26, and 39.~Prior to the first dose of rFIXFc, participants in the Sequential PK subgroup were to receive a single dose of 50 IU/kg BeneFIX administered IV in the clinic, followed by PK sampling. A single dose of 50 IU/kg rFIXFc was administered following a 120-hour washout from BeneFIX, followed by PK sampling for a baseline PK profiling. At Week 26 (±1 week) subjects were to receive a single dose of 50 IU/kg rFIXFc for repeat PK profiling."
920811|NCT01027351|B7|Baseline|Total|Total of all reporting groups
920812|NCT01027351|B6|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920814|NCT01027351|B4|Baseline|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920815|NCT01027351|B3|Baseline|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920816|NCT01027351|B2|Baseline|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920817|NCT01027351|B1|Baseline|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920818|NCT01027351|P6|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920819|NCT01027351|P5|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920820|NCT01027351|P4|Participant Flow|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920821|NCT01027351|P3|Participant Flow|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920822|NCT01027351|P2|Participant Flow|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920823|NCT01027351|P1|Participant Flow|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920824|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920825|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920826|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920827|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920828|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920829|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920830|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920831|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920832|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920833|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921205|NCT01026402|P14|Participant Flow|Part B 125mg BD Tab Int|Intermittent BD dosing
920837|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920838|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920839|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920840|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920841|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920842|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920843|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920844|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920845|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920846|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920847|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920848|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920849|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920850|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920851|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920852|NCT01027351|O6|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920853|NCT01027351|O5|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920854|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920855|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920856|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920857|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920858|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920859|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920860|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920861|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920862|NCT01027351|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920863|NCT01027351|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920864|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920865|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920866|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920867|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920868|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920869|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920870|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920871|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920872|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920873|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920874|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920875|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920876|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920877|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920878|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920879|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920914|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920880|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920881|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920882|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920883|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920884|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920885|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920886|NCT01027351|O2|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920887|NCT01027351|O1|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) in the parent study, were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920888|NCT01027351|O4|Outcome|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920889|NCT01027351|O3|Outcome|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920890|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920891|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920892|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920893|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920894|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920895|NCT01027351|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920896|NCT01027351|O2|Outcome|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920897|NCT01027351|O1|Outcome|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920898|NCT01027351|E6|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study
920899|NCT01027351|E5|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920900|NCT01027351|E4|Reported Event|3rMenB+OMV NZ|Subjects who had previously received one dose of rMenB +OMV NZ vaccine (at 12 months of age) were administered two doses of rMenB +OMV NZ vaccine, at 40 and 42 months of age in the present study.
920901|NCT01027351|E3|Reported Event|3rMenB|Subjects who had previously received one dose of rMenB vaccine (at 12 months of age) were administered two doses of rMenB vaccine, at 40 and 42 months of age in the present study.
920902|NCT01027351|E2|Reported Event|5rMenB+OMV NZ|Subjects who had received four doses of rMenB +OMV NZ vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB +OMV NZ vaccine, at 40 months of age in the present study.
920903|NCT01027351|E1|Reported Event|5rMenB|Subjects who had received four doses of rMenB vaccine (at 2,4,6 and 12 months of age) in the parent study were administered a fifth dose of rMenB vaccine, at 40 months of age in the present study.
920904|NCT01027286|B3|Baseline|Total|Total of all reporting groups
920905|NCT01027286|B2|Baseline|Control|No Vitagel used during primary total knee arthroplasty
920906|NCT01027286|B1|Baseline|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920907|NCT01027286|P2|Participant Flow|Control|No Vitagel used during primary total knee arthroplasty
920908|NCT01027286|P1|Participant Flow|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920909|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
920910|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920911|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
920912|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920913|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
920915|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
921043|NCT01026909|P2|Participant Flow|Control|Observation
920916|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920917|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
920918|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920919|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
920920|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920921|NCT01027286|O2|Outcome|Control|No Vitagel used during primary total knee arthroplasty
920922|NCT01027286|O1|Outcome|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920923|NCT01027286|E2|Reported Event|Control|No Vitagel used during primary total knee arthroplasty
920924|NCT01027286|E1|Reported Event|Vitagel|Vitagel [Orthovita Inc., Malvern, PA], a collagen/thrombin and autologous platelet hemostatic agent, is applied just prior to surgical closure during primary total knee arthroplasty
920925|NCT01027273|B3|Baseline|Total|Total of all reporting groups
920926|NCT01027273|B2|Baseline|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920927|NCT01027273|B1|Baseline|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920928|NCT01027273|P2|Participant Flow|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920929|NCT01027273|P1|Participant Flow|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920930|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
921076|NCT01026831|E1|Reported Event|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
920931|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920932|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920933|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
921223|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
920934|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920935|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920936|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920937|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920938|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920939|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920940|NCT01027273|O2|Outcome|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920959|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920941|NCT01027273|O1|Outcome|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920942|NCT01027273|E2|Reported Event|Usual Care (Delayed Intervention)|"The control group was offered the chance to take part in the 6-week session intervention after 12 months after enrollment into the trial.~Prevent Return of Stroke: The intervention arm participated in the intervention shortly after enrolling in the trial. The usual care arm was offered the intervention after 12 months from enrolling in the trial."
920943|NCT01027273|E1|Reported Event|Peer-Led Stroke Recurrence Prevention Education|"The intervention group participated in a 6-session course held over a 6-week period. The Prevent Return of Stroke Workshop, led by trained peer educators, aimed to help participants control the risk factors for stroke, thereby preventing recurrence of strokes.~Prevent Return of Stroke: Prevent Return of Stroke is a community-based, peer-led stroke recurrence prevention program. This is a bilingual (English/Spanish) education program written at a 4th grade reading level, and contains simple, actionable, messages, easily taught by lay leaders, and focuses on enhancing self-efficacy to make lifestyle changes, to help reduce stroke recurrence risk factors. It consists of 6 sessions (1½ hours each) held over 6-weeks. Topics include learning the risk factors for stroke, controlling hypertension, LDL cholesterol, preventing blood clots, medication adherence, and stress management.The intervention arm will participate in the intervention shortly after enrolling in the trial."
920944|NCT01027195|B3|Baseline|Total|Total of all reporting groups
920945|NCT01027195|B2|Baseline|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920946|NCT01027195|B1|Baseline|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920947|NCT01027195|P2|Participant Flow|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920948|NCT01027195|P1|Participant Flow|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920949|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920950|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920951|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920952|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920953|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920954|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920955|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920956|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920957|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920958|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920960|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920961|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920962|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920963|NCT01027195|O2|Outcome|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920964|NCT01027195|O1|Outcome|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920965|NCT01027195|E2|Reported Event|Standard Bovie Electrocautery|Standard Bovie electrocautery [Valleylab, Boulder, Colorado] used on surgical site during primary total hip arthroplasty to deliver high frequency electrical current to seal tissues and blood vessels.
920985|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921224|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
920966|NCT01027195|E1|Reported Event|Bipolar Radiofrequency|Aquamantys 6.0 bipolar sealer [Salient Surgical Technologies, Portsmouth, New Hampshire] used on surgical site during primary total hip arthroplasty to deliver radiofrequency energy coupled with saline solution irrigation for hemostatic sealing (i.e. shrinking of collagen in the walls of tissue vessels) at lower temperatures (<100 degrees Celsius) than standard Bovie electrocautery.
920967|NCT01027000|B1|Baseline|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
920968|NCT01027000|P1|Participant Flow|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
920969|NCT01027000|O1|Outcome|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
920970|NCT01027000|E1|Reported Event|Treatment (Combination of Chemotherapy and Transplant)|"Preparative: Patients receive 1 of 2 preparative regimens (Reg) chosen by the treating institution~Reg1: Rituximab (RTX) 500 mg/m^2 IV on days -7, -1, 7, and 14 & fludarabine phosphate (FP) 30 mg/m^2 IV & busulfan 0.8 mg/kg IV on days -5 to -2~Reg 2: RTX 500 mg/m^2 IV on days -7, -1, 7, and 14 & FP 30 mg/m^2 IV on days -5 to -2 & cyclophosphamide 1 g/m^2 IV on days -5 to -3~Graft-vs-host disease (GVHD) prophylaxis: Patients treated with preparative regimen 1 received either GVHD prophylaxis regimen 1 or 2; those given preparative regimen 2 received regimen 2~Reg 1: Tacrolimus PO or IV & oral sirolimus 12 mg on day -2 through day 60, followed by taper until day 180 & methotrexate (MTX) 5 mg/m^2 IV on days 1, 3, and 6.~Reg 2: Tacrolimus PO or IV on day -2 through day 60, followed by taper until day 180 & MTX 5mg/m^2 IV on days 1, 3, 6, & 11 Transplantation: allogeneic peripheral blood transplant on day 0 Maintenance: RTX 500 mg/m^2 IV at 3, 6, 9, & 12 months post-transplant"
920971|NCT01026974|B5|Baseline|Total|Total of all reporting groups
920972|NCT01026974|B4|Baseline|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
920973|NCT01026974|B3|Baseline|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920974|NCT01026974|B2|Baseline|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
920975|NCT01026974|B1|Baseline|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
920976|NCT01026974|P4|Participant Flow|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
920977|NCT01026974|P3|Participant Flow|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920978|NCT01026974|P2|Participant Flow|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
920979|NCT01026974|P1|Participant Flow|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
920980|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
920981|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920982|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
920983|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920984|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921564|NCT01026220|O1|Outcome|Group 2|Regimen I
920986|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
920987|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920988|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
920989|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920990|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
920991|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
920992|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
920993|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920994|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
920995|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
920996|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
920997|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
920998|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
920999|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921000|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921001|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
921002|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921003|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
921004|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921005|NCT01026974|O2|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
921006|NCT01026974|O1|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921007|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
921008|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921009|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921010|NCT01026974|O3|Outcome|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
921011|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921012|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921013|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921014|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921015|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921016|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921017|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921018|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921565|NCT01026220|O3|Outcome|Group 7|no risk-adapted radiation therapy
921019|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch -up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921020|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921021|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921022|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921023|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921024|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921025|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921026|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921027|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921028|NCT01026974|O3|Outcome|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921029|NCT01026974|O2|Outcome|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921030|NCT01026974|O1|Outcome|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921031|NCT01026974|E4|Reported Event|Naive_6062|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 60 and 62 months of age in the present study.
921032|NCT01026974|E3|Reported Event|Naive_4042|Vaccine-naive subjects who received two catch-up doses of rMenB+OMV NZ vaccine at 40 and 42 months of age in the present study.
921033|NCT01026974|E2|Reported Event|4rMenB+OMV NZ|Subjects received three primary doses of rMenB+OMV NZ vaccine (at the age of 6-8 months; 2 months after and at 12 months) in parent study and one booster dose of rMenB+OMV NZ vaccine at 40 months of age in the present study.
921034|NCT01026974|E1|Reported Event|4rMenB|Subjects received three primary doses of rMenB vaccine (at the age of 6-8months; 2 months after and at 12 months) in parent study and one booster dose of rMenB vaccine at 40 months of age in the present study.
921035|NCT01026948|B1|Baseline|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
921074|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
921077|NCT01026818|B4|Baseline|Total|Total of all reporting groups
921036|NCT01026948|P1|Participant Flow|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
921037|NCT01026948|O1|Outcome|Acceptability|Maternal views were assessed using semi-structured diaries
921038|NCT01026948|O1|Outcome|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
921039|NCT01026948|E1|Reported Event|Propess and Monica AN24 Care Package|"Women who are eligible and consent to recruitment will receive the Propess and Monica AN24 care package for outpatient induction of labour.~Propess© consists of a drug delivery device containing 10 mg Dinoprostone dispersed throughout its hydrogel matrix. The retrieval vaginal insert expands to twice its size and releases a continuous and predictable dose of Dinoprostone at a rate of approximately 0.3 mg/hr over 24 hours (4-5 mg PGE2 over 12 hours.~AN24 Monica is a portable, battery powered device designed to passively monitor a pregnant mother and unborn baby. The device is attached via a suitable cable assembly which in turn attaches to 5 standard disposable electrodes placed on the abdomen of a pregnant woman and is intended for use in either the home or hospital environment."
921040|NCT01026909|B3|Baseline|Total|Total of all reporting groups
921041|NCT01026909|B2|Baseline|Control|observation
921566|NCT01026220|O2|Outcome|Group 6|risk-adapted radiation therapy
921044|NCT01026909|P1|Participant Flow|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
921045|NCT01026909|O2|Outcome|Control|Observation
921046|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
921047|NCT01026909|O2|Outcome|Control|Observation
921048|NCT01026909|O1|Outcome|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
921049|NCT01026909|E2|Reported Event|Control|Observation
921050|NCT01026909|E1|Reported Event|Injection|Aristospan 20mg: Triamcinolone hexacetonide injectable suspension, USP, 20mg/mL Parenteral. One single dose.
921051|NCT01026844|B3|Baseline|Total|Total of all reporting groups
921052|NCT01026844|B2|Baseline|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
921053|NCT01026844|B1|Baseline|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
921054|NCT01026844|P2|Participant Flow|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
921055|NCT01026844|P1|Participant Flow|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
921056|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
921057|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
921058|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
921059|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
921060|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
921061|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
921062|NCT01026844|O2|Outcome|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
921063|NCT01026844|O1|Outcome|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
921064|NCT01026844|E2|Reported Event|HCQ (Hydroxychloroquine)|HCQ at escalating doses (400mg, 600mg, 800mg, and 1000mg QD)
921065|NCT01026844|E1|Reported Event|Erlotinib Plus HCQ (Hydroxychloroquine)|Erlotinib at 150mg QD and HCQ at escalating doses (400mg, 600mg, 800mg and 1000mg QD)
921066|NCT01026831|B3|Baseline|Total|Total of all reporting groups
921067|NCT01026831|B2|Baseline|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
921068|NCT01026831|B1|Baseline|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
921069|NCT01026831|P2|Participant Flow|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
921070|NCT01026831|P1|Participant Flow|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
921071|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
921072|NCT01026831|O1|Outcome|Tafluprost|One drop of preservative-free vehicle per eye in the morning, and one drop of preservative-free tafluprost (0.0015%) per eye in the evening for 12 weeks.
921073|NCT01026831|O2|Outcome|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
921075|NCT01026831|E2|Reported Event|Timolol Maleate|One drop of preservative-free timolol maleate (0.5%) per eye twice daily for 12 weeks.
921078|NCT01026818|B3|Baseline|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921079|NCT01026818|B2|Baseline|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921080|NCT01026818|B1|Baseline|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921081|NCT01026818|P4|Participant Flow|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921082|NCT01026818|P3|Participant Flow|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921083|NCT01026818|P2|Participant Flow|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921084|NCT01026818|P1|Participant Flow|Screen - BNSRP|BNSRP surgery during Screening Period.
921085|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921086|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921087|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921088|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921089|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921090|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921091|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921092|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921093|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921094|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921095|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921096|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921097|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921098|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921099|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921100|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921101|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921102|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921103|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921104|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921200|NCT01026402|B2|Baseline|Part A 50mg BD Soln Cont|Continuous BD dosing
921201|NCT01026402|B1|Baseline|Part A 25mg BD Soln Cont|Continuous BD dosing
921105|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921106|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921107|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921108|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921109|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921110|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921111|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921112|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921113|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921114|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921115|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921116|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921117|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921118|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921119|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921120|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921121|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921122|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921123|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921124|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921125|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921126|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921127|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921128|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921129|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921130|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921131|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921132|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921133|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921134|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921135|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921136|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921137|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921138|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921139|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921140|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921141|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921142|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921143|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921144|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921145|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921146|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921147|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921148|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921149|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921150|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921151|NCT01026818|O3|Outcome|Placebo|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-Week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921152|NCT01026818|O2|Outcome|Tadalafil 20 mg PRN|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921153|NCT01026818|O1|Outcome|Tadalafil 5 mg OaD|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921154|NCT01026818|E7|Reported Event|Placebo (Open-Label Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921155|NCT01026818|E6|Reported Event|Tadalfil 20 mg PRN (Open-Label Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921156|NCT01026818|E5|Reported Event|Tadalafil 5 mg OaD (Open-Label Period)|Tadalafil 5 mg OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period, and a 3-month, Open-Label Period with tadalafil 5 mg OaD.
921157|NCT01026818|E4|Reported Event|Placebo (Double-Blind Period/Washout Period)|Placebo OaD + Placebo PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
921158|NCT01026818|E3|Reported Event|Tadalafil 20 mg PRN (Double-Blind Period/Washout Period)|Placebo OaD + Tadalafil 20 mg PRN for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
921159|NCT01026818|E2|Reported Event|Tadalafil 5 mg OaD (Double-Blind Period/Washout Period)|Tadalafil 5 mg once a day (OaD) + Placebo as required/on demand (PRN) for 9 months during Double-Blind, Placebo-Controlled Treatment Period, followed by a 6-week, Drug-Free Washout Period.
921160|NCT01026818|E1|Reported Event|Screen - BNSRP|Had bilateral nerve-sparing radical prostatectomy (BNSRP) surgery during Screening Period.
921161|NCT01026805|B1|Baseline|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921162|NCT01026805|P1|Participant Flow|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921163|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921164|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921165|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921166|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921167|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921168|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921169|NCT01026805|O1|Outcome|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921170|NCT01026805|E1|Reported Event|Hysteroscopic Morcellator Treatment Group|Subjects underwent hysteroscopic tissue removal of intrauterine polyps and/or myomas using the Interlace Medical tissue removal device.
921171|NCT01026792|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
921172|NCT01026792|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
921173|NCT01026792|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
921174|NCT01026792|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. For complete responders, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or for 2 courses after complete response criteria are first met. For other patients, treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
921175|NCT01026454|B3|Baseline|Total|Total of all reporting groups
921176|NCT01026454|B2|Baseline|Valacyclovir Then Acyclovir|valacyclovir 1.5 g orally twice daily for 12 weeks, 2 week washout, then acyclovir 400 mg orally twice daily for 12 weeks
921177|NCT01026454|B1|Baseline|Acyclovir Then Valacyclovir|acyclovir 400 mg orally twice daily for 12 weeks, 2 week washout, then valacyclovir 1.5 g orally twice daily for 12 weeks
921178|NCT01026454|P2|Participant Flow|Valacyclovir Then Acyclovir|Valacyclovir 1.5 g orally twice daily (12 weeks), Washout (2 weeks), Acyclovir 400 mg orally twice daily (12 weeks)
921179|NCT01026454|P1|Participant Flow|Acyclovir Then Valacyclovir|Acyclovir 400 mg orally twice daily (12 weeks), Washout (2 weeks), Valacyclovir 1.5 g orally twice daily (12 weeks)
921180|NCT01026454|O2|Outcome|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
921181|NCT01026454|O1|Outcome|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
921182|NCT01026454|E2|Reported Event|Valacyclovir|valacyclovir 1.5 g twice daily either in first intervention period or second
921183|NCT01026454|E1|Reported Event|Acyclovir|acyclovir 400 mg twice daily 400 mg either in first intervention period or second
921184|NCT01026402|B18|Baseline|Total|Total of all reporting groups
921185|NCT01026402|B17|Baseline|Part A 100mg BD Soln Cont|Continuous BD dosing
921186|NCT01026402|B16|Baseline|Part A 70mg BD Soln Cont|Continuous BD dosing
921187|NCT01026402|B15|Baseline|Part B 170mg BD Tab Int|Intermittent BD dosing
921188|NCT01026402|B14|Baseline|Part B 125mg BD Tab Int|Intermittent BD dosing
921189|NCT01026402|B13|Baseline|Part A 225mg BD Tab Int|Intermittent BD dosing
921190|NCT01026402|B12|Baseline|Part A 170mg BD Tab Int|Intermittent BD dosing
921191|NCT01026402|B11|Baseline|Part A 125mg BD Tab Int|Intermittent BD dosing
921192|NCT01026402|B10|Baseline|Part A 100mg BD Tab Int|Intermittent BD dosing
921193|NCT01026402|B9|Baseline|Part A 175mg QD Tab Cont|Continuous QD dosing
921194|NCT01026402|B8|Baseline|Part A 125mg QD Tab Cont|Continuous QD dosing
921195|NCT01026402|B7|Baseline|Part A 100mg QD Tab Cont|Continuous QD dosing
921196|NCT01026402|B6|Baseline|Part A 125mg QD Soln Cont|Continuous QD dosing
921197|NCT01026402|B5|Baseline|Part A 75mg QD Soln Cont|Continuous QD dosing
921198|NCT01026402|B4|Baseline|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921199|NCT01026402|B3|Baseline|Part B 50mg BD Soln Cont|Continuous BD dosing
921206|NCT01026402|P13|Participant Flow|Part A 225mg BD Tab Int|Intermittent BD dosing
921207|NCT01026402|P12|Participant Flow|Part A 170mg BD Tab Int|Intermittent BD dosing
921208|NCT01026402|P11|Participant Flow|Part A 125mg BD Tab Int|Intermittent BD dosing
921209|NCT01026402|P10|Participant Flow|Part A 100mg BD Tab Int|Intermittent BD dosing
921210|NCT01026402|P9|Participant Flow|Part A 175mg QD Tab Cont|Continuous QD dosing
921211|NCT01026402|P8|Participant Flow|Part A 125mg QD Tab Cont|Continuous QD dosing
921212|NCT01026402|P7|Participant Flow|Part A 100mg QD Tab Cont|Continuous QD dosing
921213|NCT01026402|P6|Participant Flow|Part A 125mg QD Soln Cont|Continuous QD dosing
921214|NCT01026402|P5|Participant Flow|Part A 75mg QD Soln Cont|Continuous QD dosing
921215|NCT01026402|P4|Participant Flow|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921216|NCT01026402|P3|Participant Flow|Part B 50mg BD Soln Cont|Continuous BD dosing
921217|NCT01026402|P2|Participant Flow|Part A 50mg BD Soln Cont|Continuous BD dosing
921218|NCT01026402|P1|Participant Flow|Part A 25mg BD Soln Cont|Continuous BD dosing
921219|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921220|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921221|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921222|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921230|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921231|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921232|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921233|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921234|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921235|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921236|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921237|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921238|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921239|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921240|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921241|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921242|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921243|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921244|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921245|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921246|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921247|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921248|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921249|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921250|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921251|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921252|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921253|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921254|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921255|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921256|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921257|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921258|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921259|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921260|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921261|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921262|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921263|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921264|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921265|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921266|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921267|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921268|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921269|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921270|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921271|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921272|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921273|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921274|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921275|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921276|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921277|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921278|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921279|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921280|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921281|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921282|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921283|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921284|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921285|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921286|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921287|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921288|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921289|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921290|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921291|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921292|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921293|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921294|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921295|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921296|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921297|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921298|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921299|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921300|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921301|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921302|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921303|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921304|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921305|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921306|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921307|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921308|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921309|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921310|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921311|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921312|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921313|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921314|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921315|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921316|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921317|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921318|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921319|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921320|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921321|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921322|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921323|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921324|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921325|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921326|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921327|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921328|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921329|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921330|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921331|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921332|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921333|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921334|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921335|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921336|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921337|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921338|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921339|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921340|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921341|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921342|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921343|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921344|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921345|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921346|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921347|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921348|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921349|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921350|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921351|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921352|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921353|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921354|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921355|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921356|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921357|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921358|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921359|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921360|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921361|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921362|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921363|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921364|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921365|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921366|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921367|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921368|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921369|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921370|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921371|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921372|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921373|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921374|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921375|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921376|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921377|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921378|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921379|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921380|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921381|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921382|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921383|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921384|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921385|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921386|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921387|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921388|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921389|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921390|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921391|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921392|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921393|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921394|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921395|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921396|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921397|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921398|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921399|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921400|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921401|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921402|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921403|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921404|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921405|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921406|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921407|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921408|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921409|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921410|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921411|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921412|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921413|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921414|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921415|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921416|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921417|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921418|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921419|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921420|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921421|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921422|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921423|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921424|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921425|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921426|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921427|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921428|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921429|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921430|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921431|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921432|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921433|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921434|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921435|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921436|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921437|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921438|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921439|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921440|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921441|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921442|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921443|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921444|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921445|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921446|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921447|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921448|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921449|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921450|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921451|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921452|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921453|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921454|NCT01026402|O19|Outcome|Part B 50mg BD Tablet Fed|Continuous BD dosing
921455|NCT01026402|O18|Outcome|Part B 50mg BD Tablet Fasted|Continuous BD dosing
921456|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921457|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921458|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921459|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921460|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921461|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921462|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921463|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921464|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921465|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921466|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921467|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921468|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921469|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921470|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921471|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921472|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921473|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921474|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921475|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921476|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921477|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921478|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921479|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921480|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921481|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921482|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921483|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921484|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921485|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921486|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921487|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921488|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921489|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921490|NCT01026402|O17|Outcome|Part A 100mg BD Soln Cont|Continuous BD dosing
921491|NCT01026402|O16|Outcome|Part A 70mg BD Soln Cont|Continuous BD dosing
921492|NCT01026402|O15|Outcome|Part B 170mg BD Tab Int|Intermittent BD dosing
921493|NCT01026402|O14|Outcome|Part B 125mg BD Tab Int|Intermittent BD dosing
921494|NCT01026402|O13|Outcome|Part A 225mg BD Tab Int|Intermittent BD dosing
921495|NCT01026402|O12|Outcome|Part A 170mg BD Tab Int|Intermittent BD dosing
921496|NCT01026402|O11|Outcome|Part A 125mg BD Tab Int|Intermittent BD dosing
921497|NCT01026402|O10|Outcome|Part A 100mg BD Tab Int|Intermittent BD dosing
921498|NCT01026402|O9|Outcome|Part A 175mg QD Tab Cont|Continuous QD dosing
921499|NCT01026402|O8|Outcome|Part A 125mg QD Tab Cont|Continuous QD dosing
921500|NCT01026402|O7|Outcome|Part A 100mg QD Tab Cont|Continuous QD dosing
921501|NCT01026402|O6|Outcome|Part A 125mg QD Soln Cont|Continuous QD dosing
921502|NCT01026402|O5|Outcome|Part A 75mg QD Soln Cont|Continuous QD dosing
921503|NCT01026402|O4|Outcome|Part B Fed/Fasted 50mg BD Tab Cont|Continuous BD dosing
921504|NCT01026402|O3|Outcome|Part B 50mg BD Soln Cont|Continuous BD dosing
921505|NCT01026402|O2|Outcome|Part A 50mg BD Soln Cont|Continuous BD dosing
921506|NCT01026402|O1|Outcome|Part A 25mg BD Soln Cont|Continuous BD dosing
921507|NCT01026402|E18|Reported Event|Part B - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
921508|NCT01026402|E17|Reported Event|Part B - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
921509|NCT01026402|E16|Reported Event|Part B - AZD2014 BD 50 mg Tablet Fed/Fasted|Continuous BD dosing
921510|NCT01026402|E15|Reported Event|Part B - AZD2014 50 mg BD Tablet Fasted/Fed|Continuous BD dosing
921511|NCT01026402|E14|Reported Event|Part B - AZD2014 50 mg BD Solution|Continuous BD dosing
921512|NCT01026402|E13|Reported Event|Part A - Intermittent AZD2014 225 mg BD Tablet|Intermittent BD dosing
921513|NCT01026402|E12|Reported Event|Part A - Intermittent AZD2014 170 mg BD Tablet|Intermittent BD dosing
921514|NCT01026402|E11|Reported Event|Part A - Intermittent AZD2014 125 mg BD Tablet|Intermittent BD dosing
921515|NCT01026402|E10|Reported Event|Part A - Intermittent AZD2014 100 mg BD Tablet|Intermittent BD dosing
921516|NCT01026402|E9|Reported Event|Part A - AZD2014 75 mg QD Solution|Continuous QD dosing
921517|NCT01026402|E8|Reported Event|Part A - AZD2014 70 mg BD Solution|Continuous BD dosing
921518|NCT01026402|E7|Reported Event|Part A - AZD2014 50 mg BD Solution|Continuous BD dosing
921519|NCT01026402|E6|Reported Event|Part A - AZD2014 25 mg BD Solution|Continuous BD dosing
921520|NCT01026402|E5|Reported Event|Part A - AZD2014 175 mg QD Tablet|Continuous QD dosing
921521|NCT01026402|E4|Reported Event|Part A - AZD2014 125 mg QD Tablet|Continuous QD dosing
921522|NCT01026402|E3|Reported Event|Part A - AZD2014 125 mg QD Solution|Continous QD dosing
921523|NCT01026402|E2|Reported Event|Part A - AZD2014 100 mg QD Tablet|Continuous QD dosing
921524|NCT01026402|E1|Reported Event|Part A - AZD2014 100 mg BD Solution|Continuous BD dosing
921525|NCT01026389|B3|Baseline|Total|Total of all reporting groups
921526|NCT01026389|B2|Baseline|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
921527|NCT01026389|B1|Baseline|Gadovist|Patient received contrast-enhanced MRA with Gadovist
921528|NCT01026389|P2|Participant Flow|Dotarem|Patients received contrast-enhanced MRA with Dotarem
921529|NCT01026389|P1|Participant Flow|Gadovist|Patient received contrast-enhanced MRA with Gadovist
921530|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
921531|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
921532|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
921533|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
921534|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
921535|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
921536|NCT01026389|O2|Outcome|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
921537|NCT01026389|O1|Outcome|Gadovist|Patient received contrast-enhanced MRA with Gadovist
921538|NCT01026389|E2|Reported Event|Dotarem, Interventional|Patients received contrast-enhanced MRA with Dotarem
921539|NCT01026389|E1|Reported Event|Gadovist|Patient received contrast-enhanced MRA with Gadovist
921540|NCT01026324|B4|Baseline|Total|Total of all reporting groups
921541|NCT01026324|B3|Baseline|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
921542|NCT01026324|B2|Baseline|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
921543|NCT01026324|B1|Baseline|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV pharmacological study: Correlative studies laboratory biomarker analysis: Correlative studies"
921544|NCT01026324|P3|Participant Flow|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3(30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
921545|NCT01026324|P2|Participant Flow|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
921546|NCT01026324|P1|Participant Flow|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
921547|NCT01026324|O3|Outcome|Treatment (Dinaciclib) Dose Level 3|"Patients receive dinaciclib at Dose Level 3 (30 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
921548|NCT01026324|O2|Outcome|Treatment (Dinaciclib) Dose Level 2|"Patients receive dinaciclib at Dose Level 2 (20 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
921549|NCT01026324|O1|Outcome|Treatment (Dinaciclib) Dose Level 1|"Patients receive dinaciclib at Dose Level 1 (10 mg/m2 IV) over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
921550|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
921551|NCT01026324|O1|Outcome|Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~dinaciclib: Given IV"
921552|NCT01026324|E3|Reported Event|Dose Level 3 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 30 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
921632|NCT01026038|P3|Participant Flow|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921553|NCT01026324|E2|Reported Event|Dose Level 2 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 20 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
921554|NCT01026324|E1|Reported Event|Dose Level 1 - Treatment (Dinaciclib)|"Patients receive dinaciclib IV over 4 hours on Day 1. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.~Dose: 10 MG/M2~Dinaciclib: Given IV~Pharmacological study: Correlative studies~Laboratory biomarker analysis: Correlative studies"
921555|NCT01026220|B1|Baseline|INDUCTION THERAPY (ABVE-PC)|All Patients
921556|NCT01026220|P3|Participant Flow|REGIMEN II (SER)|Patients receive ifosfamide IV continuously on days 1-4, vinorelbine ditartrate IV over 6-30 minutes on days 1 and 5, and filgrastim SC or IV daily beginning on day 6 and continuing until blood counts recover. Treatment repeats every 21 days for 2 courses in the absence of unacceptable toxicity or disease progression. Patients then receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
921557|NCT01026220|P2|Participant Flow|REGIMEN I (RER)|Patients receive 2 more courses of ABVE-PC in the absence of unacceptable toxicity or disease progression.
921558|NCT01026220|P1|Participant Flow|INDUCTION THERAPY (ABVE-PC)|All Patients
921559|NCT01026220|O3|Outcome|Group 3|Regimen II
921560|NCT01026220|O2|Outcome|Group 2|Regimen I
921561|NCT01026220|O1|Outcome|Group 1|All Patients
921562|NCT01026220|O1|Outcome|Group 1|All Patients
921563|NCT01026220|O2|Outcome|Group 3|Regimen II
921580|NCT01026194|B2|Baseline|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921581|NCT01026194|B1|Baseline|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921582|NCT01026194|P2|Participant Flow|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921583|NCT01026194|P1|Participant Flow|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921584|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921585|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921586|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921587|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921588|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921589|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921590|NCT01026194|O2|Outcome|Teneli/Teneli + Pio|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921591|NCT01026194|O1|Outcome|Placebo/Teneli + Pio|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.
921592|NCT01026194|E4|Reported Event|Teneli/Teneli + Pio (Data Through Week 52)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
921593|NCT01026194|E3|Reported Event|Placebo/Teneli + Pio (Data From Week 12 to Week 52)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.
921594|NCT01026194|E2|Reported Event|Teneli/Teneli + Pio (Data Through Week 12)|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
921595|NCT01026194|E1|Reported Event|Placebo/Teneli + Pio (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.
921596|NCT01026142|B3|Baseline|Total|Total of all reporting groups
921597|NCT01026142|B2|Baseline|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks~pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
921598|NCT01026142|B1|Baseline|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
921599|NCT01026142|P2|Participant Flow|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921600|NCT01026142|P1|Participant Flow|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921601|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921738|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
921602|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921603|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921604|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921605|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921606|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921607|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921608|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921609|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921610|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921611|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921612|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921613|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921614|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921615|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921616|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921617|NCT01026142|O2|Outcome|Capecitabine + Trastuzumab + Pertuzumab|"capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days every 3 weeks~pertuzumab: 840 mg iv loading, then 420 mg iv every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
921618|NCT01026142|O1|Outcome|Capecitabine + Trastuzumab|"capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days every 3 weeks~trastuzumab [Herceptin]: 8 mg/kg iv loading, then 6 mg/kg iv every 3 weeks"
921619|NCT01026142|E2|Reported Event|Capecitabine + Trastuzumab + Pertuzumab|"Capecitabine [Xeloda]: 1000 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Pertuzumab: 840 mg IV loading dose, then 420 mg IV every 3 weeks~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks"
921620|NCT01026142|E1|Reported Event|Capecitabine + Trastuzumab|"Capecitabine [Xeloda]: 1250 mg/m2 po twice daily for 14 days followed by 7 day rest. Cycles occur every 3 weeks.~Trastuzumab [Herceptin]: 8 mg/kg IV loading dose, then 6 mg/kg IV every 3 weeks."
921621|NCT01026103|B1|Baseline|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
921622|NCT01026103|P1|Participant Flow|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
921623|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
921624|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
921625|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
921626|NCT01026103|O1|Outcome|Tri Staple|"This is a single arm study.~Tri Staple Technology stapler : This is a single arm study."
921627|NCT01026103|E1|Reported Event|Tri Staple|This is a single arm study.
921628|NCT01026038|B4|Baseline|Total|Total of all reporting groups
921629|NCT01026038|B3|Baseline|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921630|NCT01026038|B2|Baseline|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921631|NCT01026038|B1|Baseline|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921739|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
921633|NCT01026038|P2|Participant Flow|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921634|NCT01026038|P1|Participant Flow|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921635|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921636|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921637|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921638|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921639|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921640|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
951225|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
921641|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921642|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921643|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921644|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921645|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921646|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921647|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921648|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921649|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921650|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921651|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921652|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921653|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921654|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921655|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921656|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921657|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921658|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921659|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921660|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921661|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921662|NCT01026038|O3|Outcome|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921663|NCT01026038|O2|Outcome|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921809|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
921664|NCT01026038|O1|Outcome|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921665|NCT01026038|E3|Reported Event|7vPnC/13vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.
921666|NCT01026038|E2|Reported Event|7vPnC/7vPnC/13vPnC|Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.
921667|NCT01026038|E1|Reported Event|13vPnC/13vPnC/13vPnC|Single dose (0.5 milliliter [mL]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.
921668|NCT01026012|B1|Baseline|Combined Stress Group|patient's were monitor for approximately 30 minutes following regadenoson infusion
921669|NCT01026012|P1|Participant Flow|Combined Stress Group|Subjects had a sub-maximal symptom limited stress test (<85% MPHR)then immediately followed by pharmological stress test with the infusion of regadenoson 400mcg infused over 10-20 seconds.
921670|NCT01026012|O1|Outcome|Combined Stress Group|Side effect will be monitored/reported by subject during stress test and 30 mins in recovery.
921671|NCT01026012|E1|Reported Event|Safety|patient's were monitor for approximately 30 minutes following regadenoson infusion
921672|NCT01025843|B11|Baseline|Total|Total of all reporting groups
921673|NCT01025843|B10|Baseline|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
921674|NCT01025843|B9|Baseline|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921675|NCT01025843|B8|Baseline|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
921676|NCT01025843|B7|Baseline|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921677|NCT01025843|B6|Baseline|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921678|NCT01025843|B5|Baseline|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
921679|NCT01025843|B4|Baseline|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
921680|NCT01025843|B3|Baseline|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921681|NCT01025843|B2|Baseline|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
921682|NCT01025843|B1|Baseline|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
921683|NCT01025843|P10|Participant Flow|Candesartan → Pbo → 12 mg → 24 mg → 38 mg|Candesartan in Period 1; Placebo in Period 2; 12 mg MK-5478 in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods
921684|NCT01025843|P9|Participant Flow|Candesartan→8 mg→ 18 mg → 2 mg Fed → 38 mg|Candesartan in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921685|NCT01025843|P8|Participant Flow|2 mg → 8 mg → 18 mg → 2 mg Fed → Pbo|2 mg MK-5478 in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Placebo in Period 5. There was a minimum 7 days washout between periods.
921686|NCT01025843|P7|Participant Flow|2 mg→Candesartan→ Pbo → Candesartan Fed → 38 mg|2 mg MK-5478 in Period 1; Candesartan in Period 2; Placebo in Period 3; Candesartan in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921687|NCT01025843|P6|Participant Flow|2 mg→Pbo → Candesartan → Pbo Fed → 38 mg|2 mg MK-5478 in Period 1; Placebo in Period 2; Candesartan in Period 3; Placebo in Period 4 with a high fat meal; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921688|NCT01025843|P5|Participant Flow|Pbo → 8 mg→ 18 mg → 2 mg Fed → Candesartan|Placebo in Period 1; 8 mg MK-5478 in Period 2; 18 mg MK-5478 in Period 3; 2 mg MK-5478 in Period 4 with a high fat meal; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
921689|NCT01025843|P4|Participant Flow|1 mg → 5 mg → 12 mg → Pbo → Candesartan|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Placebo in Period 4; and Candesartan in Period 5. There was a minimum 7 days washout between periods.
921690|NCT01025843|P3|Participant Flow|1 mg → Candesartan → Pbo → 24 mg → 38 mg|1 mg MK-5478 in Period 1; Candesartan in Period 2: Placebo in Period 3; 24 mg MK- 5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921691|NCT01025843|P2|Participant Flow|1 mg → 5 mg → 12 mg → Candesartan → Pbo|1 mg MK-5478 in Period 1; 5 mg MK-5478 in Period 2; 12 mg MK-5478 in Period 3; Candesartan in Period 4; and Placebo in Period 5. There was a minimum 7 days washout between periods.
921692|NCT01025843|P1|Participant Flow|Pbo → 5 mg → Candesartan → 24 mg → 38 mg|Placebo in Period 1; 5 mg MK-5478 in Period 2; Candesartan in Period 3; 24 mg MK-5478 in Period 4; and 38 mg MK-5478 in Period 5. There was a minimum 7 days washout between periods.
921693|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
921694|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
921695|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
921696|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
921697|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
921698|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
921699|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
921700|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
921701|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
921702|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
921703|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
921704|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
921705|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
921706|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
921707|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
921708|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
921709|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
921710|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
921711|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
921712|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
921713|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
921714|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
921715|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
921716|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
921717|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
921718|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
921719|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
921720|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
921721|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
921722|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
921723|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
921724|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
921725|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
921726|NCT01025843|O13|Outcome|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
921727|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
921728|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
921729|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
921730|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
921731|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
921732|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
921733|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
921734|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
921735|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
921736|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
921737|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
921929|NCT01025037|B1|Baseline|Conexa|Rotator cuff repair using Conexa
921740|NCT01025843|O12|Outcome|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
921741|NCT01025843|O11|Outcome|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
921742|NCT01025843|O10|Outcome|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
921743|NCT01025843|O9|Outcome|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
921744|NCT01025843|O8|Outcome|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
921745|NCT01025843|O7|Outcome|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
921746|NCT01025843|O6|Outcome|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
921747|NCT01025843|O5|Outcome|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
921748|NCT01025843|O4|Outcome|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
921749|NCT01025843|O3|Outcome|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
922354|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
921750|NCT01025843|O2|Outcome|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
921751|NCT01025843|O1|Outcome|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
921752|NCT01025843|E13|Reported Event|Candesartan Placebo|A single dose of Candesartan placebo in tablet form was orally administered during a treatment period
921753|NCT01025843|E12|Reported Event|Candesartan 32 mg - Fed|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period, preceded by a high fat breakfast
921754|NCT01025843|E11|Reported Event|Candesartan 32 mg|A single dose of 32 mg Candesartan in tablet form was orally administered during a treatment period
921755|NCT01025843|E10|Reported Event|MK-5478 Placebo|A single dose of MK-5478 Placebo in capsule form was orally administered during a treatment period
921756|NCT01025843|E9|Reported Event|MK-5478 2 mg - Fed|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period, preceded by a high fat breakfast
921757|NCT01025843|E8|Reported Event|MK-5478 38 mg|A single dose of 38 mg MK-5478 in capsule form was orally administered during a treatment period
921758|NCT01025843|E7|Reported Event|MK-5478 24 mg|A single dose of 24 mg MK-5478 in capsule form was orally administered during a treatment period
921759|NCT01025843|E6|Reported Event|MK-5478 18 mg|A single dose of 18 mg MK-5478 in capsule form was orally administered during a treatment period
921760|NCT01025843|E5|Reported Event|MK-5478 12 mg|A single dose of 12 mg MK-5478 in capsule form was orally administered during a treatment period
921761|NCT01025843|E4|Reported Event|MK-5478 8 mg|.A single dose of 8 mg MK-5478 in capsule form was orally administered during a treatment period
921762|NCT01025843|E3|Reported Event|MK-5478 5 mg|A single dose of 5 mg MK-5478 in capsule form was orally administered during a treatment period
921763|NCT01025843|E2|Reported Event|MK-5478 2 mg|A single dose of 2 mg MK-5478 in capsule form was orally administered during a treatment period
921764|NCT01025843|E1|Reported Event|MK-5478 1 mg|A single dose of 1 mg MK-5478 in capsule form was orally administered during a treatment period
921765|NCT01025830|B1|Baseline|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
921766|NCT01025830|P2|Participant Flow|Brand (Zerit/Epivir/Viramune) to Generic (Triomune)|started with brand formulation(Zerit/Epivir/Viramune) then switched to generic formulation (Triomune)
921767|NCT01025830|P1|Participant Flow|Generic (Triomune) to Brand (Zerit/Epivir/Viramune)|Started with generic formulation (Triomune) then switched to brand formulation (Zerit/Epivir/Viramune).
921768|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
921769|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
921770|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
921771|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
921772|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
921773|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
921774|NCT01025830|O6|Outcome|Brand Lamivudine|Period when subjects were on brand lamivudine
921775|NCT01025830|O5|Outcome|Generic Lamivudine|period when subjects were on generic lamivudine
921776|NCT01025830|O4|Outcome|Brand Nevirapine|Period when subjects were on brand nevirapine
921777|NCT01025830|O3|Outcome|Generic Nevirapine|period when subjects were on generic nevirapine
921778|NCT01025830|O2|Outcome|Brand Stavudine|period when subjects were on brand stavudine
921779|NCT01025830|O1|Outcome|Generic Stavudine|period when subjects were on generic stavudine
921780|NCT01025830|E3|Reported Event|Brand to Generic|started with brand formulation then switched to generic formulation
921781|NCT01025830|E2|Reported Event|Generic to Brand|Started with generic formulation then switched to brand formulation
921782|NCT01025830|E1|Reported Event|Entire Study Population|Includes groups randomized to receive generic formulation and brand formulation
921783|NCT01025817|B3|Baseline|Total|Total of all reporting groups
921784|NCT01025817|B2|Baseline|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
925133|NCT01015703|E3|Reported Event|5 mg Dose|5 mg CoVaccine HT
921785|NCT01025817|B1|Baseline|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921786|NCT01025817|P2|Participant Flow|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921822|NCT01025492|E1|Reported Event|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
921823|NCT01025336|B6|Baseline|Total|Total of all reporting groups
921949|NCT01024972|E2|Reported Event|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
922355|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
921787|NCT01025817|P1|Participant Flow|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921788|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921789|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921790|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921791|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921792|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921793|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921794|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921930|NCT01025037|P1|Participant Flow|Conexa|Rotator cuff repair using Conexa
921795|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921796|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921824|NCT01025336|B5|Baseline|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921950|NCT01024972|E1|Reported Event|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
922507|NCT01023217|B3|Baseline|Total|Total of all reporting groups
921797|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921798|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921799|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921800|NCT01025817|O2|Outcome|Mycophenolate Mofetil and Standard Dose Tacrolimus|MMF treatment arm: The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921801|NCT01025817|O1|Outcome|Everolimus and Low Dose Tacrolimus|Everolimus treatment arm: Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921802|NCT01025817|E2|Reported Event|Mycophenolate Mofetil and Standard Dose Tacrolimus|The MMF dose was initiated at 1 g b.i.d. (2 g/day). Adjustments were to be made for adverse events including, but not limited to, gastrointestinal intolerance and a decrease in WBC. MMF trough or AUC was not used to adjust dosing. In this group, tacrolimus was initiated according to local practice. The tacrolimus dose was adjusted from Day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 12 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was reduced to 7 - 10 ng/mL. After Month 6, the target level of tacrolimus was reduced to 5 - 8 ng/mL.
921803|NCT01025817|E1|Reported Event|Everolimus and Low Dose Tacrolimus|Therapeutic drug monitoring of everolimus and tacrolimus was mandatory throughout the study. From Day 5 onwards, the everolimus 0.75 mg b.i.d. dose was increased if the trough level was < 3 ng/mL, or reduced if the trough level was > 8 ng/mL. Tacrolimus was initiated according to local practice. In this treatment arm, the tacrolimus dose was adjusted from Day 3 onwards, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From Month 2 until Month 6, the target tacrolimus trough level was 3 ng/mL to 6 ng/mL. After Month 6, the tacrolimus dose was adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL.
921804|NCT01025635|B3|Baseline|Total|Total of all reporting groups
921805|NCT01025635|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
921806|NCT01025635|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
921807|NCT01025635|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
921808|NCT01025635|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
921810|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
921811|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
921812|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
921813|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
921814|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
921815|NCT01025635|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
921816|NCT01025635|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
921817|NCT01025635|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
921818|NCT01025635|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
921819|NCT01025492|B1|Baseline|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
921820|NCT01025492|P1|Participant Flow|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
921821|NCT01025492|O1|Outcome|Trilipix or Placebo|Trilipix - 135 mg tablet orally, once daily for 12 weeks; or Placebo - matching placebo tablet orally, once daily for 12 weeks
921825|NCT01025336|B4|Baseline|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921826|NCT01025336|B3|Baseline|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921827|NCT01025336|B2|Baseline|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921828|NCT01025336|B1|Baseline|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921829|NCT01025336|P5|Participant Flow|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921830|NCT01025336|P4|Participant Flow|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921831|NCT01025336|P3|Participant Flow|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921832|NCT01025336|P2|Participant Flow|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921833|NCT01025336|P1|Participant Flow|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921834|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921835|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921836|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921837|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921838|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (6115A1-3010 NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
921839|NCT01025336|O1|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
921840|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921841|NCT01025336|O2|Outcome|13vPnC (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)
921842|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921843|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921844|NCT01025336|O2|Outcome|13vPnC (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and either 13vPnC or 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2) (both 13vPnC/13vPnC and 13vPnC/23vPS dose groups)
921845|NCT01025336|O1|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921846|NCT01025336|O2|Outcome|23vPS (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2).
921847|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921848|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921849|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921850|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921851|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921852|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921853|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921854|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921855|NCT01025336|O1|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921856|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921857|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921931|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
921932|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
921858|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921859|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921860|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921861|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921862|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921863|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921864|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921865|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921866|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921867|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921868|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921869|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921870|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921871|NCT01025336|O2|Outcome|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921872|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants at least 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study 6115A1-3005 (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1)and at Year 1 (Vaccination 2)
921873|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921874|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921875|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921876|NCT01025336|O3|Outcome|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study 6115A1-3010 (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921933|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
921877|NCT01025336|O2|Outcome|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study 6115A-3010 6115A1-3010(NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921878|NCT01025336|O1|Outcome|13vPnC/13vPnC Group (23vPs Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study 6115A1-3010 (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921879|NCT01025336|E5|Reported Event|23vPS/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS ≥5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921880|NCT01025336|E4|Reported Event|13vPnC/13vPnC Group (23vPS Vaccination ≥5 Years Prior)|Participants aged 70 years of age or greater previously vaccinated with 23vPS greater than or equal to (≥) 5 years before enrollment in the parent study (NCT00546572), who completed study NCT00546572 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921881|NCT01025336|E3|Reported Event|23vPS/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never been vaccinated with 23vPS prior to enrollment into the parent study (NCT00574548), who completed study NCT00574548 receiving 23vPS administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 13vPnC administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921882|NCT01025336|E2|Reported Event|13vPnC/23vPS Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23vPS prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13vPnC administered as a single dose 0.5 mL IM at Year 0 (Vaccination 1) and 23vPS administered as a single dose 0.5 mL IM at Year 1 (Vaccination 2)
921883|NCT01025336|E1|Reported Event|13vPnC/13vPnC Group (23vPS Naïve)|Participants aged 60 to 64 years old who had never received 23-valent pneumococcal polysaccharide vaccine (23vPS) prior to enrollment into the parent study (NCT00574548), completed study NCT00574548 receiving 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0 (Vaccination 1) and at Year 1 (Vaccination 2)
921884|NCT01025271|B1|Baseline|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
921885|NCT01025271|P1|Participant Flow|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
921886|NCT01025271|O1|Outcome|PK Sampling|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
921887|NCT01025271|O1|Outcome|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
921888|NCT01025271|E1|Reported Event|Open Label|patients meeting entry criteria enrolled and pk samples obtained around dosing of daptomycin
921889|NCT01025232|B3|Baseline|Total|Total of all reporting groups
921890|NCT01025232|B2|Baseline|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921891|NCT01025232|B1|Baseline|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921892|NCT01025232|P2|Participant Flow|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921893|NCT01025232|P1|Participant Flow|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921894|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921895|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921896|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921897|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921898|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921899|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921900|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921901|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921902|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921903|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921904|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921905|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921906|NCT01025232|O2|Outcome|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921907|NCT01025232|O1|Outcome|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921908|NCT01025232|E2|Reported Event|6 Week Re-treatment|"Subjects can receive re-treatment every 6 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Every 6 weeks regimen will test potential longer duration of action of 2.0 mg ranibizumab. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921909|NCT01025232|E1|Reported Event|4 Week Re-treatment|"Subjects can receive re-treatment every 4 weeks if there is persistent or recurrent intraretinal, subretinal, or sub-RPE fluid on any OCT modality, or any evidence of hemorrhage on clinical evaluation. Subjects will go no longer than 12 weeks without treatment.~Ranibizumab: Intravitreal Injection of 2.0mg formulation"
921910|NCT01025193|B1|Baseline|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921911|NCT01025193|P1|Participant Flow|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was being used to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921912|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921934|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
921935|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
921936|NCT01025037|O1|Outcome|Conexa|Rotator cuff repair using Conexa
921937|NCT01025037|E1|Reported Event|Conexa|Rotator cuff repair using Conexa
921938|NCT01024972|B3|Baseline|Total|Total of all reporting groups
921913|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used in to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921914|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab: The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921915|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
951226|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
921916|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the pre-kidney transplant patient's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921917|NCT01025193|O1|Outcome|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab is being used in to try to decrease the amount of antibodies in the subject's blood pre-kidney transplant. This use is considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects will be given this medication as an outpatient as an intravenous infusion through the arm. The medication will be given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921918|NCT01025193|O1|Outcome|Belimumab|"Belimumab will be administered intravenously at a dose of 10mg/kg on days 0, 14, 28 and every 28 days for up to 52 weeks to normalize alloantibody levels in sensitized patients awaiting kidney transplantation. Subjects who are not able to undergo transplantation before the end of the treatment period will have final follow-up evaluation 8 weeks after the last dose of belimumab is administered.~Belimumab: Belimumab is a fully human monoclonal antibody that recognizes and inhibits BLyS ®. BLyS ® is a B-lymphocyte stimulator protein which plays a role in the development of B lymphocyte cells into plasma B cells, which then produce antibodies that can sensitize a potential transplant recipient. At the time of this trial, belimumab was not yet FDA approved and was being studied in clinical trials for the treatment of systemic lupus erythematosus. Until this trial, it had not yet been used in the transplant setting."
921919|NCT01025193|E1|Reported Event|Belimumab|"Belimumab is a monoclonal antibody. It is the first drug of its type in a new class of medications called BLyS-specific inhibitors. In March 2011, it was approved by the Food and Drug Administration (FDA) for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus (SLE) who are receiving standard therapy. In this study, belimumab was used to try to decrease the amount of antibodies in the patient waiting for kidney transplant's blood. This use was considered investigational (not approved by the Food and Drug Administration).~Belimumab : The subjects were given this medication as an outpatient as an intravenous infusion through the arm. The medication was given at the beginning of the study, two weeks later, and then every 4 weeks for up to one year pre-transplant."
921920|NCT01025154|B1|Baseline|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
921921|NCT01025154|P1|Participant Flow|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
921922|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
921923|NCT01025154|O1|Outcome|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
921924|NCT01025154|E1|Reported Event|Clofarabine, Cytarabine + Idarubicin|Induction Cycle: Clofarabine 20 mg/m^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m^2 IV daily for 3 days; Cytarabine 1 g/m^2 IV daily for 5 days
921925|NCT01025076|B1|Baseline|StomaphX|Patients with weight gain following VBG had endoluminal pouch reduction performed using the StomaphyXTM device in revisional bariatric surgery clinic
921926|NCT01025076|P1|Participant Flow|StomaphX|
921927|NCT01025076|O1|Outcome|StomaphX|
921928|NCT01025076|E1|Reported Event|StomaphX|
921939|NCT01024972|B2|Baseline|Placebo|Equiosmolar volume (5% mannitol) every 6 hours for seven days.
921940|NCT01024972|B1|Baseline|Dantrolene|Intravenous Datrolene 1.25 mg/kg (includes 5% mannitol) every 6 hours for seven days.
921941|NCT01024972|P2|Participant Flow|Placebo|"Equiosmolar volume (5% Mannitol)~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
921942|NCT01024972|P1|Participant Flow|Dantrolene|"Dantrolene 1.25mg/kg IV every 6 hours x 7 days~Dantrolene vs. Placebo: Dantrolene 1.25mg/kg IV (includes 5% mannitol) or equiosmolar placebo (5% mannitol) every 6 hours x 7 days"
921943|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
921944|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
921945|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days
921946|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
921947|NCT01024972|O2|Outcome|Placebo|equiosmolar, volume-equivalent sterile water with 5% mannitol every 6 hours x 7 days.
921948|NCT01024972|O1|Outcome|Dantrolene|Dantrolene 1.25mg/kg IV (includes 5% mannitol) every 6 hours x 7 days
921951|NCT01024959|B1|Baseline|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
921952|NCT01024959|P1|Participant Flow|Prostate Cancer Gene 3 (PCA3) Assay|PCA3 Assay : Post-Digital Rectal Exam (DRE) urine collected prior to prostate biopsy. N=495 represents the total number of subjects eligible for the study. 507 subjects were enrolled, 12 were determined to be ineligible.
921953|NCT01024959|O3|Outcome|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
921954|NCT01024959|O2|Outcome|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
921955|NCT01024959|O1|Outcome|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
921956|NCT01024959|E4|Reported Event|Subjects With no Biopsy Performed|
921957|NCT01024959|E3|Reported Event|Subjects With Negative Biopsy Result|Absence of prostate cancer defined by no positive biopsy cores (note: presence of high grade PIN and/or atypia are classified as negative biopsy results)
921958|NCT01024959|E2|Reported Event|Subjects With Positive Biopsy Result|Presence of prostate cancer defined by one or more positive biopsy cores
921959|NCT01024959|E1|Reported Event|PCA3 Assay|PCA3 Assay : Post-DRE urine collected prior to prostate biopsy
921960|NCT01024946|B1|Baseline|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
921961|NCT01024946|P1|Participant Flow|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
921962|NCT01024946|O1|Outcome|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
921963|NCT01024946|E1|Reported Event|Patients Getting Everolimus|"This is a multicenter, open label, phase II study of everolimus as a second or third line therapy for the treatment of advanced malignant pleural mesothelioma, which will also evaluate Merlin/NF2 loss as a biomarker to predict sensitivity to everolimus. Patients who have disease progression after one or two prior chemotherapy regimens will be eligible. In the first stage of this design, 19 patients will be accrued. If 6 or less patients among the first 19 patients show clinical benefit, then the study will be terminated and declared negative. If 7 or more patients show clinical benefit, than an additional 20 patients will be accrued to the second stage. At the end of the study, if 17 or more patients show clinical benefit out of a total of 39 patients enrolled, the regimen will be considered worthy of further investigation.~everolimus: Everolimus will be administered at a dose of 10mg orally once daily continuously. Dose reduction may be required depending on the type and severity"
921964|NCT01024855|B1|Baseline|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
925134|NCT01015703|E2|Reported Event|2 mg Dose|2 mg CoVaccine HT
921965|NCT01024855|P1|Participant Flow|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
921966|NCT01024855|O2|Outcome|OptiFree|30 subjects, one eye received Opti-Free RepleniSH MPS(control).
921967|NCT01024855|O1|Outcome|RevitaLens|30 subjects, one eye received RevitaLens MPS (investigational).
921968|NCT01024855|E1|Reported Event|RevitaLens and OptiFree|30 subjects, one eye received RevitaLens MPS (investigational), one eye received Opti-Free RepleniSH MPS(control).
921969|NCT01024751|B3|Baseline|Total|Total of all reporting groups
921970|NCT01024751|B2|Baseline|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921971|NCT01024751|B1|Baseline|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921972|NCT01024751|P2|Participant Flow|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921973|NCT01024751|P1|Participant Flow|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921974|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921975|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921976|NCT01024751|O2|Outcome|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921977|NCT01024751|O1|Outcome|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921978|NCT01024751|E2|Reported Event|Ciba's Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921979|NCT01024751|E1|Reported Event|Bausch & Lomb Multi-Purpose Solution|Multi-Purpose Solution to be used for disinfecting contact lenses.
921980|NCT01024738|B4|Baseline|Total|Total of all reporting groups
921981|NCT01024738|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
921982|NCT01024738|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
921983|NCT01024738|B1|Baseline|Fluoride Toothpaste|negative control toothpaste
921984|NCT01024738|P3|Participant Flow|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
921985|NCT01024738|P2|Participant Flow|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
921986|NCT01024738|P1|Participant Flow|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
921987|NCT01024738|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine oral rinse (positive control)
921988|NCT01024738|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control)
921989|NCT01024738|O1|Outcome|Fluoride Toothpaste|negative control toothpaste
921990|NCT01024738|E3|Reported Event|Chlorhexidine Oral Rinse|chlorhexidine oral rinse first,triclosan/fluoride second, fluoride last
921991|NCT01024738|E2|Reported Event|Triclosan/Fluoride Toothpaste First|triclosan/fluoride toothpaste first, fluoride toothpaste second, chlorhexidine oral rinse last
921992|NCT01024738|E1|Reported Event|Fluoride Toothpaste First|Fluoride toothpaste first,chlorhexidine oral rinse second, triclosan/fluoride last
921993|NCT01024608|B3|Baseline|Total|Total of all reporting groups
921994|NCT01024608|B2|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
921995|NCT01024608|B1|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
921996|NCT01024608|P2|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
921997|NCT01024608|P1|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
921998|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
921999|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
922000|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
922001|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
922002|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
922003|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
922004|NCT01024608|O2|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
922005|NCT01024608|O1|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
922006|NCT01024608|E2|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
922007|NCT01024608|E1|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
922008|NCT01024465|B1|Baseline|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
922009|NCT01024465|P1|Participant Flow|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
922010|NCT01024465|O1|Outcome|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
922011|NCT01024465|E1|Reported Event|ReShape Duo Balloon|"Patients seeking weight loss with a starting BMI in the 30-40 range, received the ReShape Duo Balloon~ReShape Duo Balloon: ReShape Duo Balloon"
922012|NCT01024335|B3|Baseline|Total|Total of all reporting groups
922013|NCT01024335|B2|Baseline|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
922049|NCT01024244|B5|Baseline|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
951227|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
922014|NCT01024335|B1|Baseline|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
922015|NCT01024335|P2|Participant Flow|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
922016|NCT01024335|P1|Participant Flow|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
922017|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
922018|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
922019|NCT01024335|O2|Outcome|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
922020|NCT01024335|O1|Outcome|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
922021|NCT01024335|E2|Reported Event|Naltrexone and Dronabinol|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.~Injectable naltrexone and dronabinol: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment."
922022|NCT01024335|E1|Reported Event|Naltrexone and Placebo|"A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment.~Naltrexone and placebo: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks."
922023|NCT01024309|B3|Baseline|Total|Total of all reporting groups
922024|NCT01024309|B2|Baseline|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922025|NCT01024309|B1|Baseline|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922026|NCT01024309|P2|Participant Flow|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922027|NCT01024309|P1|Participant Flow|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922028|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922029|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922030|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922031|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922032|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922033|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922034|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922035|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922036|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
925135|NCT01015703|E1|Reported Event|1 mg Dose|1 mg CoVaccine HT
922037|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922038|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922039|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922040|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922041|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922042|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922043|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922044|NCT01024309|O2|Outcome|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty
922045|NCT01024309|O1|Outcome|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty
922046|NCT01024309|E2|Reported Event|Direct Anterior Approach|Direct Anterior surgical approach for total hip arthroplasty: Direct Anterior surgical approach for total hip arthroplasty
922047|NCT01024309|E1|Reported Event|Mini-Posterior Approach|Mini-Posterior surgical approach for total hip arthroplasty: Mini-Posterior surgical approach for total hip arthroplasty
922048|NCT01024244|B6|Baseline|Total|Total of all reporting groups
922050|NCT01024244|B4|Baseline|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922051|NCT01024244|B3|Baseline|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922052|NCT01024244|B2|Baseline|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922053|NCT01024244|B1|Baseline|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922054|NCT01024244|P5|Participant Flow|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922055|NCT01024244|P4|Participant Flow|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922056|NCT01024244|P3|Participant Flow|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922057|NCT01024244|P2|Participant Flow|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922058|NCT01024244|P1|Participant Flow|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922059|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922060|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922061|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922062|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922063|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922064|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922065|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922066|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922067|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922068|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922069|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922070|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922071|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922072|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922073|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922074|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922075|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922076|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922077|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
925136|NCT01015677|B4|Baseline|Total|Total of all reporting groups
922078|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922079|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922080|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922081|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922082|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922083|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922084|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922085|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922352|NCT01023516|P1|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922086|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922087|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922088|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922089|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922090|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922091|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922092|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922093|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922094|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922095|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922096|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922097|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922098|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922099|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922100|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922101|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922102|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922103|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922104|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922105|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922106|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922107|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922108|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922109|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922110|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922111|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922112|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922113|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922114|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922115|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922116|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922117|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922118|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922119|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922120|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922121|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922347|NCT01023568|E1|Reported Event|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922122|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922123|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922124|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922125|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922126|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922127|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922128|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922129|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922130|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922131|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922132|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922133|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922134|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922135|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922136|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922137|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922138|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922139|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922140|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922141|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922142|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922143|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922144|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922145|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922146|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922147|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922148|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922189|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922149|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922150|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922151|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922152|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922153|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922154|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922155|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922156|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922157|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922348|NCT01023516|B3|Baseline|Total|Total of all reporting groups
922158|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922159|NCT01024244|O5|Outcome|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922160|NCT01024244|O4|Outcome|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922161|NCT01024244|O3|Outcome|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922162|NCT01024244|O2|Outcome|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922163|NCT01024244|O1|Outcome|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922164|NCT01024244|E5|Reported Event|200 mg LY2599506 Once Daily|Participants received 200 mg of LY2599506 po once daily (QD)(Two 100-mg LY2599506 capsules prior to morning meal, 2 matching placebo capsules prior to evening meal for 12 weeks).
922165|NCT01024244|E4|Reported Event|400 mg LY2599506|Participants received two 100-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922166|NCT01024244|E3|Reported Event|200 mg LY2599506|Participants received two 50-mg capsules of LY2599506 po BID, prior to morning and evening meals for 12 weeks.
922167|NCT01024244|E2|Reported Event|100 mg LY2599506|Participants received 50 milligrams (mg) capsules of LY2599506 po BID (One 50-mg LY2599506 capsule + 1 matching placebo capsule), prior to morning and evening meals for 12 weeks.
922168|NCT01024244|E1|Reported Event|0 Milligrams (mg) Placebo|Participants received 2 placebo capsules by mouth (po) twice daily (BID), prior to morning and evening meals for 12 weeks.
922169|NCT01024036|B3|Baseline|Total|Total of all reporting groups
922170|NCT01024036|B2|Baseline|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922171|NCT01024036|B1|Baseline|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922172|NCT01024036|P2|Participant Flow|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922173|NCT01024036|P1|Participant Flow|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922174|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922175|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922176|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922177|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922178|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922179|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922180|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922181|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922182|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922183|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922184|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922185|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922186|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922187|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922188|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922190|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922191|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922192|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922193|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922194|NCT01024036|O1|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922195|NCT01024036|O2|Outcome|Siltuximab + Best Supportive Care (BSC)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922196|NCT01024036|O1|Outcome|Placebo + Best Supportive Care (BSC)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922197|NCT01024036|E3|Reported Event|Siltuximab + BSC (Unblinded)|Open label 11 mg/kg Siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922198|NCT01024036|E2|Reported Event|Placebo + Best Supportive Care (BSC) (Blinded)|Placebo administered as a 1-hour intravenous infusion every 3 weeks + BSC
922199|NCT01024036|E1|Reported Event|Siltuximab + Best Supportive Care (BSC) (Blinded)|11 mg/kg siltuximab administered as a 1-hour intravenous infusion every 3 weeks + BSC
922200|NCT01023841|B3|Baseline|Total|Total of all reporting groups
922201|NCT01023841|B2|Baseline|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922202|NCT01023841|B1|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922203|NCT01023841|P2|Participant Flow|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922204|NCT01023841|P1|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922205|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922206|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922207|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922208|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922209|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922210|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922211|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922212|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922213|NCT01023841|O2|Outcome|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922214|NCT01023841|O1|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922215|NCT01023841|E2|Reported Event|Vehicle Sterile Solution|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922216|NCT01023841|E1|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop applied to a sterile single-use-per-eye applicator and applied to upper eyelid margin (where the eyelashes meet the skin) once nightly for 4 months.
922217|NCT01023815|B5|Baseline|Total|Total of all reporting groups
922218|NCT01023815|B4|Baseline|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922219|NCT01023815|B3|Baseline|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922233|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922234|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922220|NCT01023815|B2|Baseline|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
922221|NCT01023815|B1|Baseline|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
922222|NCT01023815|P4|Participant Flow|Randomized: Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922223|NCT01023815|P3|Participant Flow|Randomized: Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922304|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
922224|NCT01023815|P2|Participant Flow|Randomized: Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
922225|NCT01023815|P1|Participant Flow|Pre-randomized: Not-randomization Patients (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~Not-randomization Patients (NRP) was defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP)"
922226|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922227|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922228|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922229|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922230|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922231|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922232|NCT01023815|O2|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922235|NCT01023815|O1|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922236|NCT01023815|O3|Outcome|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922237|NCT01023815|O2|Outcome|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922269|NCT01023659|B1|Baseline|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922238|NCT01023815|O1|Outcome|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
922239|NCT01023815|E4|Reported Event|Group C - Standard Twice-a-day Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, in order to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine: after randomization the cyclosporine dose was gradually adjusted to reach and maintain C2 blood levels of 200-450 ng/mL between Month 6 and Month 12.~Prednisone: the dose of prednisone was kept stable at 5 mg/day in the morning."
922240|NCT01023815|E3|Reported Event|Group B - Steroid Withdrawal Group|"Everolimus: after randomization the everolimus dose was adjusted, if necessary, to maintain a C0 within 6-10 ng/mL until M12.~Cyclosporine:after randomization the cyclosporine dose was adjusted to maintain CsA C2 levels within 300-500 ng/mL until M12.~Prednisone: starting from Visit 5 (day 90 ± 28 days), oral prednisone was tapered until complete stop. It was recommended to taper prednisone by 1 mg/week until complete stop in 5 to 6 weeks."
922241|NCT01023815|E2|Reported Event|Group A - Once-a-day Regimen|"Change in study design (Amendment 1) stopped the randomization into Group A (once-a-day regimen), due to overall slow enrollment rate and shifted all relative objectives from primary/secondary to exploratory, due to small sample size.~Everolimus: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole daily dose of everolimus was taken in the morning, at the same time of the CsA and steroid dosing. At the Rand+1W visit, the everolimus dose was adjusted to reach and maintain everolimus blood levels between 5 and 8 ng/mL until end of Month 12.~Cyclosporine: in patients randomized to Group A before Amend 1 approval, from the day following randomization, the whole cyclosporine daily dose was taken in the morning. The dose was then adjusted to maintain C2 levels between 350 and 700 ng/mL.~Prednisone: In patients randomized to Group A before Amend 1 approval, the dose of prednisone was kept stable at 5 mg/day in the morning."
922242|NCT01023815|E1|Reported Event|Not Randomized Population (NRP)|"At the Baseline visit, performed up to 48 hours after graft reperfusion, eligible patients entered the Pre-Randomization Period and started study drug treatment (D1 = 1st day of everolimus treatment).~This population defined in whom a renal transplantation was performed, received at least one dose of study drug (everolimus) but who did not qualify for randomization at Visit 5, Day 90. This group was addressed as not randomized patients (NRP) and described with respect to baseline characteristics, treatment and outcome variables."
922243|NCT01023776|B1|Baseline|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
922244|NCT01023776|P1|Participant Flow|Live Monovalent H1N1 Vaccine|Subjects received 2 doses of vaccine 0.1 ml in each nostril intranasally 28 days apart
922245|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
922246|NCT01023776|O1|Outcome|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
922247|NCT01023776|E1|Reported Event|Live Monovalent H1N1 Vaccine|Live Monovalent H1N1 vaccine 0.1 ml in each nostril times 2 doses given intranasally 28 days apart
922248|NCT01023724|B3|Baseline|Total|Total of all reporting groups
922249|NCT01023724|B2|Baseline|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
922250|NCT01023724|B1|Baseline|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
922251|NCT01023724|P2|Participant Flow|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
922252|NCT01023724|P1|Participant Flow|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
922253|NCT01023724|O2|Outcome|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
922254|NCT01023724|O1|Outcome|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
922255|NCT01023724|E2|Reported Event|Acuvail|Acuvail to be given preoperatively at BID for one day pre op and then post operatively for 14 days.
922256|NCT01023724|E1|Reported Event|Xibrom|Xibrom drops to be given pre operatively for one day BID, and then postoperatively for 14 days.
922257|NCT01023711|B1|Baseline|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
922258|NCT01023711|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
922259|NCT01023711|O1|Outcome|Inactivated H1N1 Vaccine|Inactivated H1N1 vaccine: 0.5 ml IM into Deltoid region of arm
922260|NCT01023711|O1|Outcome|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
922261|NCT01023711|E1|Reported Event|H1N1 Monovalent Influenza Vaccine|0.5 mL IM of Influenza A (H1N1) 2009 Monovalent Vaccine
922262|NCT01023672|B1|Baseline|Armodifinil|150-250 mg armodafinil by mouth daily
922263|NCT01023672|P1|Participant Flow|Armodifinil|150-250 mg armodafinil by mouth daily
922264|NCT01023672|O1|Outcome|Armodifinil|150-250 mg armodafinil by mouth daily
922265|NCT01023672|E1|Reported Event|Armodifinil|150-250 mg armodafinil by mouth daily
922266|NCT01023659|B4|Baseline|Total|Total of all reporting groups
922267|NCT01023659|B3|Baseline|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
922268|NCT01023659|B2|Baseline|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922349|NCT01023516|B2|Baseline|Placebo|Matched Placebo Tablets
922270|NCT01023659|P3|Participant Flow|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
922271|NCT01023659|P2|Participant Flow|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922272|NCT01023659|P1|Participant Flow|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922273|NCT01023659|O1|Outcome|All Eligible Participants|All participants who were eligible to receive medication
922274|NCT01023659|O3|Outcome|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
922275|NCT01023659|O2|Outcome|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922276|NCT01023659|O1|Outcome|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922277|NCT01023659|E3|Reported Event|Varenicline + Motivational Emails|"participants receive Champix (2mg/day) plus weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks~varenicline : varenicline, 1 mg twice daily plus weekly motivational emails for 12 weeks"
922278|NCT01023659|E2|Reported Event|Motivational Emails|"participants receive weekly motivational emails for 12 weeks.~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922279|NCT01023659|E1|Reported Event|Bupropion + Motivational Emails|"participants receive Zyban (300mg/day) plus weekly motivational emails for 12 weeks.~bupropion : bupropion, 150 mg twice daily plus weekly motivational emails for 12 weeks~motivational emails : brief motivational emails, sent weekly for 12 weeks"
922280|NCT01023581|B8|Baseline|Total|Total of all reporting groups
922281|NCT01023581|B7|Baseline|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
922282|NCT01023581|B6|Baseline|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
922283|NCT01023581|B5|Baseline|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
922284|NCT01023581|B4|Baseline|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
922285|NCT01023581|B3|Baseline|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922286|NCT01023581|B2|Baseline|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922287|NCT01023581|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922288|NCT01023581|P7|Participant Flow|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
922289|NCT01023581|P6|Participant Flow|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
922290|NCT01023581|P5|Participant Flow|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
922291|NCT01023581|P4|Participant Flow|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
922292|NCT01023581|P3|Participant Flow|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922293|NCT01023581|P2|Participant Flow|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922294|NCT01023581|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922409|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922295|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
922296|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
922297|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
922298|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
922299|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922300|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922301|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922302|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
922303|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
922350|NCT01023516|B1|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922305|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
922306|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922307|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922308|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922309|NCT01023581|O7|Outcome|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
922310|NCT01023581|O6|Outcome|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
922311|NCT01023581|O5|Outcome|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
922312|NCT01023581|O4|Outcome|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
922313|NCT01023581|O3|Outcome|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922314|NCT01023581|O2|Outcome|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922315|NCT01023581|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922316|NCT01023581|E7|Reported Event|Alogliptin 12.5 BID + Metformin 1000 BID|Alogliptin 12.5 mg, tablets, orally, twice daily and Metformin 1000 mg, capsules, orally, twice daily for up to 26 weeks.
922317|NCT01023581|E6|Reported Event|Alogliptin 12.5 BID + Metformin 500 BID|Alogliptin 12.5mg, tablets, orally, twice daily and Metformin 500 mg, capsules, orally, twice daily for up to 26 weeks.
922318|NCT01023581|E5|Reported Event|Metformin 1000 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 1000 mg capsules, orally, twice daily for up to 26 weeks.
922319|NCT01023581|E4|Reported Event|Metformin 500 BID|Alogliptin placebo-matching tablets, orally, twice daily and Metformin 500 mg capsules, orally, twice daily for up to 26 weeks.
922320|NCT01023581|E3|Reported Event|Alogliptin 12.5 BID|Alogliptin 12.5 mg, tablets, orally, twice daily (BID) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922321|NCT01023581|E2|Reported Event|Alogliptin 25 QD|Alogliptin 25 mg, tablets, orally, once daily (QD) and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922322|NCT01023581|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, twice daily and Metformin placebo-matching capsules, orally, twice daily for up to 26 weeks.
922323|NCT01023568|B4|Baseline|Total|Total of all reporting groups
922324|NCT01023568|B3|Baseline|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922325|NCT01023568|B2|Baseline|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922326|NCT01023568|B1|Baseline|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922327|NCT01023568|P3|Participant Flow|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922328|NCT01023568|P2|Participant Flow|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922329|NCT01023568|P1|Participant Flow|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922330|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922331|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922332|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922333|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922334|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922410|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922335|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922336|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922337|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922338|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922339|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922340|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922341|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922342|NCT01023568|O3|Outcome|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922343|NCT01023568|O2|Outcome|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922344|NCT01023568|O1|Outcome|Macintosh Blade|"Intubation with Macintosh blade laryngoscope~Macintosh blade: Intubation with Macintosh blade laryngoscope"
922345|NCT01023568|E3|Reported Event|Truview PCD|"Intubation with the Truview PCD laryngoscope~Truview PCD: Intubation with Truview PCD laryngoscope."
922346|NCT01023568|E2|Reported Event|Glidescope|"Intubation with Glidescope laryngoscope~Glidescope: Intubation with Glidescope laryngoscope."
922351|NCT01023516|P2|Participant Flow|Placebo|Matched Placebo Tablets
922356|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922357|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922358|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922359|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922360|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922361|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922362|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922363|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922364|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922365|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922366|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922367|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922368|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922369|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922370|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922371|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922372|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922373|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922374|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922375|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922376|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922377|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922378|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922379|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922380|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922381|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922382|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922383|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922384|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922385|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922386|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922387|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922388|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922389|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922390|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922391|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922392|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922393|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922394|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922395|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922396|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922397|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922398|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922399|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922400|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922401|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922402|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922403|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922404|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922405|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922406|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922407|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922408|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922412|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922413|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922414|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922415|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922416|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922417|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922418|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922419|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922420|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922421|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922422|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922423|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922424|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922425|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
922426|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922427|NCT01023516|O2|Outcome|Placebo|Matched Placebo Tablets
951228|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
922428|NCT01023516|O1|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922429|NCT01023516|E2|Reported Event|Placebo|Matched Placebo Tablets
922430|NCT01023516|E1|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
922431|NCT01023308|B3|Baseline|Total|Total of all reporting groups
922432|NCT01023308|B2|Baseline|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922433|NCT01023308|B1|Baseline|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922434|NCT01023308|P2|Participant Flow|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922435|NCT01023308|P1|Participant Flow|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922436|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922437|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922438|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922439|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922440|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922441|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922442|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922443|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922444|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922445|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922446|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922447|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922448|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922449|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922450|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922494|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
927899|NCT01010399|P1|Participant Flow|Boosted Lexiva With Lovaza|
922451|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922452|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922453|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922454|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922455|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922456|NCT01023308|O2|Outcome|Placebo + Bortezomib|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day.
922457|NCT01023308|O1|Outcome|Panobinostat + Bortezomib|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922458|NCT01023308|E2|Reported Event|PBO+BTZ|Placebo was given as a hard gelatin capsule in the image of Panobinostat . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV) injection. Dexamethasone was given as an oral dose of 20 mg/day..
922459|NCT01023308|E1|Reported Event|PAN+BTZ|Panobinostat was given 20 mg hard gelatin capsules . Bortezomib was given at 1.3 mg/m2 as a 3 to 5 second bolus intravenous (IV)injection. Dexamethasone was given as an oral dose of 20 mg/day.
922460|NCT01023256|B5|Baseline|Total|Total of all reporting groups
922461|NCT01023256|B4|Baseline|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922462|NCT01023256|B3|Baseline|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922463|NCT01023256|B2|Baseline|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922464|NCT01023256|B1|Baseline|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922465|NCT01023256|P4|Participant Flow|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
922466|NCT01023256|P3|Participant Flow|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922467|NCT01023256|P2|Participant Flow|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922468|NCT01023256|P1|Participant Flow|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922469|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922470|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922471|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922472|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922473|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922474|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922475|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922476|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922477|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922478|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922479|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922480|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922481|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922482|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922483|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922484|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922485|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922486|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922487|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922488|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922489|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922490|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922491|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922492|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922493|NCT01023256|O4|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922495|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922496|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922497|NCT01023256|O5|Outcome|Pooled Placebo|All patients who were randomized to the placebo arms in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses).
922498|NCT01023256|O4|Outcome|Pooled Active|All patients receiving MOR103 at any dose
922499|NCT01023256|O3|Outcome|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922500|NCT01023256|O2|Outcome|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922501|NCT01023256|O1|Outcome|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922502|NCT01023256|E5|Reported Event|Pooled Placebo|Pooled placebo group included all patients who were randomized to placebo in the 3 study cohorts. Placebo was administered IV once weekly for 4 weeks (total of 4 doses)
922503|NCT01023256|E4|Reported Event|Pooled Active|All patients receiving MOR103 at any dose
922504|NCT01023256|E3|Reported Event|MOR103 1.5 mg/kg|MOR103 1.5 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922505|NCT01023256|E2|Reported Event|MOR103 1.0 mg/kg|MOR103 1.0 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922506|NCT01023256|E1|Reported Event|MOR103 0.3 mg/kg|MOR103 0.3 mg/kg IV once weekly for 4 weeks (total of 4 doses)
922508|NCT01023217|B2|Baseline|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
922509|NCT01023217|B1|Baseline|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
922510|NCT01023217|P2|Participant Flow|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
922511|NCT01023217|P1|Participant Flow|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
922512|NCT01023217|O2|Outcome|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
922513|NCT01023217|O1|Outcome|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
922514|NCT01023217|E2|Reported Event|Adefovir Plus Lamivudine|"Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks~Adefovir plus Lamivudine: Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks"
922515|NCT01023217|E1|Reported Event|Adefovir Plus Entecavir|"Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks~Adefovir plus Entecavir: Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks"
922516|NCT01023178|B4|Baseline|Total|Total of all reporting groups
922517|NCT01023178|B3|Baseline|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
922518|NCT01023178|B2|Baseline|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922519|NCT01023178|B1|Baseline|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922520|NCT01023178|P3|Participant Flow|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
922521|NCT01023178|P2|Participant Flow|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922522|NCT01023178|P1|Participant Flow|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922523|NCT01023178|O3|Outcome|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
922524|NCT01023178|O2|Outcome|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922525|NCT01023178|O1|Outcome|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922526|NCT01023178|E3|Reported Event|Oral 17beta Estradiol|"17beta Estradiol: Oral pill given daily at increasing doses every 6 months for 18 months.~Progesterone, micronized: Given starting at 18 months"
922527|NCT01023178|E2|Reported Event|Oral Conjugated Equine Estrogen|"Conjugated estrogens: Oral pill, started at a low dose taken daily, dose increased every 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922528|NCT01023178|E1|Reported Event|Transdermal 17Beta Estradiol|"17Beta Estradiol - transdermal: Transdermal estrogen patch, started at low dose with increasing doses eery 6 months for 18 months~Progesterone, micronized: Given starting at 18 months"
922529|NCT01023074|B4|Baseline|Total|Total of all reporting groups
922530|NCT01023074|B3|Baseline|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922684|NCT01022112|B1|Baseline|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
922531|NCT01023074|B2|Baseline|MS:Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922532|NCT01023074|B1|Baseline|Non-MS Control|Non-MS control group
922533|NCT01023074|P3|Participant Flow|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922534|NCT01023074|P2|Participant Flow|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922535|NCT01023074|P1|Participant Flow|Non-MS Control|Non-MS control group
922536|NCT01023074|O3|Outcome|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922537|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922538|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
922539|NCT01023074|O3|Outcome|MS: Control Activity|MS group not receiving auditory training, doing control activity
951229|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
922540|NCT01023074|O2|Outcome|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922541|NCT01023074|O1|Outcome|Non-MS Control|Non-MS control group
922542|NCT01023074|O3|Outcome|Arm 3|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922543|NCT01023074|O2|Outcome|Arm 2|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922544|NCT01023074|O1|Outcome|Arm 1|Non-MS control group
922545|NCT01023074|E3|Reported Event|MS: Control Activity|"MS group not receiving auditory training, doing control activity~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922546|NCT01023074|E2|Reported Event|MS: Auditory Training|"MS group receiving auditory training~Auditory training: the study was originally set up so that half of the MS subjects would received auditory training. This intervention has since been discontinued."
922547|NCT01023074|E1|Reported Event|Non-MS Control|Non-MS control group
922548|NCT01023061|B1|Baseline|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
922549|NCT01023061|P1|Participant Flow|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone daily for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
922550|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given PO~prednisone: Given PO~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
922551|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given PO~prednisone: Given PO~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
922552|NCT01023061|O1|Outcome|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate PO and prednisone PO for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given PO~prednisone: Given PO~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
922553|NCT01023061|E1|Reported Event|Treatment (Antihormone Therapy and Radiation Therapy)|"Patients receive abiraterone acetate and prednisone for 24 weeks. Patients also receive leuprolide acetate or goserelin in weeks 1 and 13. Patients undergo external beam radiotherapy starting in week 15 for 8.5 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~abiraterone acetate: Given orally~prednisone: Given orally~leuprolide acetate: Given via injection~laboratory biomarker analysis: Correlative study~external beam radiation therapy: Undergo radiotherapy~goserelin acetate: Given via injection"
922554|NCT01023035|B4|Baseline|Total|Total of all reporting groups
922612|NCT01022762|E1|Reported Event|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922613|NCT01022567|B3|Baseline|Total|Total of all reporting groups
922555|NCT01023035|B3|Baseline|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
922556|NCT01023035|B2|Baseline|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
922557|NCT01023035|B1|Baseline|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
922558|NCT01023035|P3|Participant Flow|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
922559|NCT01023035|P2|Participant Flow|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
922759|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922560|NCT01023035|P1|Participant Flow|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
922561|NCT01023035|O3|Outcome|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
922562|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
922563|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
922564|NCT01023035|O2|Outcome|Erythropoietin Use Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
922565|NCT01023035|O1|Outcome|Ribavirin Dose Reduction Arm|After treatment for 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin of ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
922566|NCT01023035|E3|Reported Event|Treated/Not Randomized|Participants received 4 weeks of PEG2b/RBV followed by 24 or 44 weeks of boceprevir plus PEG2b/RBV depending on Hepatitis C Virus RNA (HCV-RNA) levels. Participants continued with this treatment if their serum hemoglobin remained >10 g/dL throughout the 28- or 48-week treatment period.
922567|NCT01023035|E2|Reported Event|Erythropoietin Use Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Erythropoietin Use Arm received erythropoietin for management of the anemia in addition to PEG2b/RBV and boceprevir therapies.
922568|NCT01023035|E1|Reported Event|Ribavirin Dose Reduction Arm|After the initiation of treatment with 4 weeks with PEG2b/RBV followed by 24 or 44 weeks of boceprevir, participants who became anemic (serum hemoglobin = ≤10 g/dL) within the 28- or 48-week treatment period and who were randomized to the Ribavirin (RBV) Dose Reduction Arm received reduced doses of RBV for management of the anemia in combination with PEG2b and boceprevir therapies.
922569|NCT01023022|B1|Baseline|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
922570|NCT01023022|P1|Participant Flow|Medtronic CareLink® Network|"Patients with Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
922571|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
922614|NCT01022567|B2|Baseline|Antibiotic Treatment|"Ertapenem 1 g i.v. x 1 three days~Ertapenem: ertapenem 1g x 1 i.v.for three days + after discharge levofloxacin 500 mg 1 x 1 + metronidazole 500 mg 1x3 for 7 days p.o."
922615|NCT01022567|B1|Baseline|Operative Treatment|"Regular open appendicectomy~Appendicectomy: Standard appendicectomy"
922572|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
922573|NCT01023022|O1|Outcome|Medtronic CareLink® Network|"Patients with implanted ICD or CRT-D devices, who will be monitored by the Medtronic CareLink® System.~The System consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website.~Medtronic CareLink® Network: The Medtronic CareLink® Network consists of the Medtronic CareLink® Monitor and Medtronic CareLink® Clinician Website"
922574|NCT01023022|E1|Reported Event|Patients With Implanted ICD or CRT-D Devices|Patients with implanted ICD or CRT-D devices, who will be monitored via CareLink Network System
922575|NCT01022996|B1|Baseline|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922588|NCT01022762|P1|Participant Flow|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922589|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922590|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922576|NCT01022996|P1|Participant Flow|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922577|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922578|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922579|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922580|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922616|NCT01022567|P2|Participant Flow|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days.
922617|NCT01022567|P1|Participant Flow|Appendectomy|Open appendectomy
922618|NCT01022567|O2|Outcome|Antibiotic Therapy|
922619|NCT01022567|O1|Outcome|Appendectomy|
922620|NCT01022567|E2|Reported Event|Antibiotic Therapy|Ertapenem 1 g x 1 for three days followed by levofloxacin 500 mg x 1 combined with metronidazole 500 mg x 3 for seven days
922621|NCT01022567|E1|Reported Event|Appendectomy|Open appendectomy
922685|NCT01022112|P5|Participant Flow|Placebo|TA-7284 Placebo, once daily for 12 weeks
922581|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922582|NCT01022996|O1|Outcome|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922583|NCT01022996|E1|Reported Event|RAD001|Patients with a history of classical Hodgkin lymphoma (ie, nodular sclerosing, mixed cellularity, lymphocyte-rich, lymphocyte-depleted) whose disease had progressed after receiving high-dose chemotherapy with AHSCT (if eligible) and/or after therapy with a gemcitabine- or vinorelbine- or vinblastine-containing regimen, were enrolled into this study. Patients had at least one site of measurable disease at baseline ≥ 2.0 cm in the longest transverse diameter and clearly measurable in at least two perpendicular dimensions, as determined by CT scan. Patients received 10 mg of everolimus (two 5 mg tablets), self-administered orally once daily (qd), continuously from Cycle 1 Day 1 until progression of disease, unacceptable toxicity, death or discontinuation from the study for any other reason. The treatment cycle consisted of 28 days.
922584|NCT01022762|B3|Baseline|Total|Total of all reporting groups
922585|NCT01022762|B2|Baseline|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922586|NCT01022762|B1|Baseline|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922587|NCT01022762|P2|Participant Flow|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922591|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922592|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922593|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922594|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922595|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922596|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922597|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922598|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922599|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922600|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922601|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922602|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922603|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922604|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922605|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922606|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922607|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922608|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922609|NCT01022762|O2|Outcome|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922610|NCT01022762|O1|Outcome|Repaglinide|1 mg repaglinide twice daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 4 mg three times daily
922611|NCT01022762|E2|Reported Event|Gliclazide|80 mg gliclazide once daily (weeks 0-4), titrated (individually adjusted) to maintenance dose (weeks 4-16). Maximum dose is 160 mg twice daily
922622|NCT01022502|B1|Baseline|All Participants (Refined/Crude Ointment)|Two symmetrically comparable plaques on each participant were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Photographs of the lesions were taken and lesion severity was evaluated at baseline and at week 2, 4, 6, and 8.
922623|NCT01022502|P1|Participant Flow|All Participants|In all participants, two bilateral symmetric plaques were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Participants were instructed to avoid cross-contamination between the two treatment sites by washing hands throughly between applications. Treatment was performed until complete clearing, up to a maxmum period of 8 weeks.
922624|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922625|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922626|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922627|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922908|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
922628|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922629|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922630|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922631|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922632|NCT01022502|O2|Outcome|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922633|NCT01022502|O1|Outcome|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks.
922634|NCT01022502|E2|Reported Event|Refined Indigo Naturalis Ointment|Refined indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil, filtering, then mixing with petroleum jelly and wax.
922635|NCT01022502|E1|Reported Event|Crude Indigo Naturalis Ointment|Crude indigo naturalis ointment was prepared by mixing indigo naturalis powder with olive oil,petroleum jelly and wax.
922636|NCT01022398|B3|Baseline|Total|Total of all reporting groups
922637|NCT01022398|B2|Baseline|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
922638|NCT01022398|B1|Baseline|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
922639|NCT01022398|P2|Participant Flow|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
922640|NCT01022398|P1|Participant Flow|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
922641|NCT01022398|O2|Outcome|Placebo|Subjects will receive placebo (an exact replica of the vitamin D capsule that does not contain any medically active substance) by mouth weekly
922642|NCT01022398|O1|Outcome|Vitamin D|Subjects will receive Vitamin D supplementation 10,000 international units of cholecalciferol (vitamin D3) by mouth weekly
922643|NCT01022398|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
922644|NCT01022307|B3|Baseline|Total|Total of all reporting groups
922645|NCT01022307|B2|Baseline|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
922646|NCT01022307|B1|Baseline|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
922647|NCT01022307|P2|Participant Flow|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI.
922648|NCT01022307|P1|Participant Flow|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
922649|NCT01022307|O2|Outcome|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. Two were excluded because of evidence of malingering.
922650|NCT01022307|O1|Outcome|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
922651|NCT01022307|E2|Reported Event|Group 2: With a History of TBI|28 patients with a history of TBI. Most of these patients had suffered mild TBI. 24 underwent multimodal MR imaging.
922652|NCT01022307|E1|Reported Event|Group 1: no History of TBI|184 participants with no history of traumatic brain injury (TBI).
922653|NCT01022242|B3|Baseline|Total|Total of all reporting groups
922654|NCT01022242|B2|Baseline|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
922681|NCT01022112|B4|Baseline|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
922682|NCT01022112|B3|Baseline|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
922683|NCT01022112|B2|Baseline|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
922655|NCT01022242|B1|Baseline|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
922656|NCT01022242|P2|Participant Flow|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01: PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
922657|NCT01022242|P1|Participant Flow|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo: Placebo is a physiological sodium chloride solution, which is clear and colourless."
922658|NCT01022242|O2|Outcome|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
951230|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
922659|NCT01022242|O1|Outcome|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
922660|NCT01022242|E2|Reported Event|PXL01|"PXL01 is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~PXL01 is a synthetic peptide sequentially derived from human lactoferrin. PXL01 is formulated in a viscous solution of sodium hyaluronate. The drug product is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound."
922661|NCT01022242|E1|Reported Event|Placebo|"Placebo is administered locally between the flexor tendon and the tendon sheath and around the tendon sheath at a volume of 0.5 ml. Administration of the product is carried out after repair of the flexor tendon but before closure of the surgical wound.~Placebo is a physiological sodium chloride solution, which is clear and colourless."
922662|NCT01022203|B3|Baseline|Total|Total of all reporting groups
922663|NCT01022203|B2|Baseline|Arm 2|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
922664|NCT01022203|B1|Baseline|Arm 1|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
922665|NCT01022203|P2|Participant Flow|PTSD Family Education|"Educational Intervention.~PTSD Family Education: Education about PTSD for couples."
922666|NCT01022203|P1|Participant Flow|Structured Approach Therapy|"Couple's Therapy Intervention~Structured Approach Therapy: Couple's Therapy for PTSD"
922667|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-treatment (12 weeks), Follow-up (12 weeks after post-treatment).
922668|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
922669|NCT01022203|O2|Outcome|PTSD Family Education|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
922670|NCT01022203|O1|Outcome|Structured Approach Therapy|Pre-Treatment, Post-Treatment (12 weeks), Follow-up (12 weeks after post-treatment).
922671|NCT01022203|O2|Outcome|PTSD Family Education|Veterans participate in pre-treatment assessment; post-treatment assessment within one week week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
922672|NCT01022203|O1|Outcome|Structured Approach Therapy|Veterans participate in pre-treatment assessment; post-treatment assessment within one week of the last study assessment, and a follow-up assessment 12 weeks after the last intervention session. Partners also participate but do not provide data.
922673|NCT01022203|E2|Reported Event|PTSD Family Education (PFE)|"Couple-Based Education called PTSD Family Education (PFE) teaches couple about PTSD symptoms, related problems, and treatment.~PTSD Family Education (PFE): PTSD Family Education (PFE) provides education for veterans with PTSD and their partners explaining the signs and symptoms of PTSD; psychological problems that are comorbid with PTSD; and treatments for PTSD. Skills training and psychotherapy are not included."
922674|NCT01022203|E1|Reported Event|Structured Approach Therapy (SAT)|"Couple-Based Intervention called Structured Approach Therapy (SAT) provides skills training to couple so they can reduce PTSD.~Structured Approach Therapy (SAT): Structured Approach Therapy (SAT) intervention includes education about the impact of PTSD on relationships; skills training to teach couples recognize and stop avoidance behavior; behavior activation training; emotion regulation training; and a couple-based intervention to teach veterans with PTSD to identify and disclose trauma memories and related emotions to their partners. The couple is then trained to support disclosure while practicing empathic communication."
922675|NCT01022190|B1|Baseline|Etoricoxib|
922676|NCT01022190|P1|Participant Flow|Etoricoxib, 90 mg, Orally, Ones a Day|Patients who underwent total hip arthroplasty were administered Etoricoxib, 90 mg, orally, one a day for a 7 day period to prevent heterotopic ossification of the hip joint after the operation.
922677|NCT01022190|O1|Outcome|Etoricoxib, 90 mg, Orally, One a Day for 7 Days Period|Etoricoxib, 90 mg, which was administered orally, for a 7-day period to all participants.
922678|NCT01022190|E1|Reported Event|Etoricoxib|
922679|NCT01022112|B6|Baseline|Total|Total of all reporting groups
922680|NCT01022112|B5|Baseline|Placebo|TA-7284 Placebo, once daily for 12 weeks
922686|NCT01022112|P4|Participant Flow|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
922687|NCT01022112|P3|Participant Flow|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
922688|NCT01022112|P2|Participant Flow|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
922689|NCT01022112|P1|Participant Flow|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
922690|NCT01022112|O5|Outcome|Placebo|TA-7284 Placebo, once daily for 12 weeks
922691|NCT01022112|O4|Outcome|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
922692|NCT01022112|O3|Outcome|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
922693|NCT01022112|O2|Outcome|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
922694|NCT01022112|O1|Outcome|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
922695|NCT01022112|E5|Reported Event|Placebo|TA-7284 Placebo, once daily for 12 weeks
922696|NCT01022112|E4|Reported Event|TA-7284-High|TA-7284 300 mg, once daily for 12 weeks
922697|NCT01022112|E3|Reported Event|TA-7284-High-middle|TA-7284 200 mg, once daily for 12 weeks
922698|NCT01022112|E2|Reported Event|TA-7284-Low-middle|TA-7284 100 mg, once daily for 12 weeks
922699|NCT01022112|E1|Reported Event|TA-7284-Low|TA-7284 50 mg, once daily for 12 weeks
922700|NCT01022073|B3|Baseline|Total|Total of all reporting groups
951231|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
922701|NCT01022073|B2|Baseline|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
922702|NCT01022073|B1|Baseline|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
922703|NCT01022073|P2|Participant Flow|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
922704|NCT01022073|P1|Participant Flow|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
922705|NCT01022073|O2|Outcome|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
922706|NCT01022073|O1|Outcome|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
922707|NCT01022073|E2|Reported Event|Subthalamic Nucleus Group|Cohort of subjects who received DBS-STN as part of the CSP 468 intervention trial, and still have their device working and in place.
922708|NCT01022073|E1|Reported Event|Globus Pallidus Interna Group|Cohort of subjects who received DBS-GPi as part of the CSP 468 intervention trial, and still have their device working and in place.
922709|NCT01021878|B3|Baseline|Total|Total of all reporting groups
922710|NCT01021878|B2|Baseline|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
922711|NCT01021878|B1|Baseline|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
922712|NCT01021878|P2|Participant Flow|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~N=27"
922713|NCT01021878|P1|Participant Flow|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~N=33"
922714|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment~Dianeal: glucose based dialysis solution"
922715|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
922716|NCT01021878|O2|Outcome|Dextrose|"dianeal, Control group, standard treatment~Dianeal: glucose based dialysis solution"
922717|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
922718|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
922719|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
922720|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
922721|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
922722|NCT01021878|O2|Outcome|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution"
922723|NCT01021878|O1|Outcome|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution"
922724|NCT01021878|E2|Reported Event|Dextrose|"Control group, standard treatment~Dianeal: glucose based dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
922725|NCT01021878|E1|Reported Event|Icodextrin|"glucose sparing alternative dialysis solution~icodextrin: glucose sparing dialysis solution~There were a total of 25 adverse events reported of which 10 in the control group and 15 in the intervention group. Six were considered a severe event, 4 in the control group and 2 in the intervention group."
922726|NCT01021852|B9|Baseline|Total|Total of all reporting groups
922727|NCT01021852|B8|Baseline|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922728|NCT01021852|B7|Baseline|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922754|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922755|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922756|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922757|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
922729|NCT01021852|B6|Baseline|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922730|NCT01021852|B5|Baseline|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922731|NCT01021852|B4|Baseline|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922732|NCT01021852|B3|Baseline|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922733|NCT01021852|B2|Baseline|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922734|NCT01021852|B1|Baseline|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922780|NCT01021813|P3|Participant Flow|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
923086|NCT01020799|E2|Reported Event|Placebo|Placebo matching both AZD7268 and escitalopram
922735|NCT01021852|P8|Participant Flow|Placebo/MK-6096 20 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922736|NCT01021852|P7|Participant Flow|MK-6096 20 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 20 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922758|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
951232|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
922737|NCT01021852|P6|Participant Flow|Placebo/MK-6096 10 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922738|NCT01021852|P5|Participant Flow|MK-6096 10 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 10 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922739|NCT01021852|P4|Participant Flow|Placebo/MK-6096 5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922740|NCT01021852|P3|Participant Flow|MK-6096 5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for 2 overnight PSG recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo to MK-6096 for the first 3 days and no treatment the remaining 11 days. During Treatment Period 2, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922741|NCT01021852|P2|Participant Flow|Placebo/MK-6096 2.5 mg|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29, on which days they receive placebo 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive MK-6096 30 minutes before bedtime.
922781|NCT01021813|P2|Participant Flow|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922782|NCT01021813|P1|Participant Flow|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922808|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
927900|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
922742|NCT01021852|P1|Participant Flow|MK-6096 2.5 mg/Placebo|Prior to Treatment Period 1, participants undergo a 3 week screening period and receive single-blind placebo for the last 2 weeks if screening criteria are met. During Treatment Period 1, participants receive MK-6096 2.5 mg daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory on Days 1 and 29 for overnight polysomnography (PSG) recordings, on which days they receive MK-6096 30 minutes before bedtime. Treatment Period 1 is followed by a 2-week washout period during which the participant receives single-blind placebo for the first 3 days and no treatment for the remaining 11 days. During Treatment Period 2, participants receive dose-matched placebo to MK-6096 daily for 4 weeks at 5-10 minutes before bedtime and return to the sleep laboratory for 2 overnight PSG recordings on Days 1 and 29 (Study Days 44 and 72), on which days they receive placebo 30 minutes before bedtime.
922743|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922744|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922745|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922746|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922747|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
922748|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922749|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922750|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922751|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922752|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
922753|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922760|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922761|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922762|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
922763|NCT01021852|O5|Outcome|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922764|NCT01021852|O4|Outcome|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922765|NCT01021852|O3|Outcome|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922766|NCT01021852|O2|Outcome|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922767|NCT01021852|O1|Outcome|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
922768|NCT01021852|E7|Reported Event|Post-Study/Follow-up|Participants that completed the study or prematurely discontinued during either treatment period received a 14-day (from last dose) follow-up phone call to assess for AEs. The Post-Study/Follow-up period was the period that occurred between study completion/ treatment discontinuation and the 14-day follow-up phone call (14 days after the last dose of double-blind study medication).
922769|NCT01021852|E6|Reported Event|Washout|Participants administered single-blind placebo study medication for the first 3 nights of the washout period that occurred between Treatment Period 1 and Treatment Period 2, immediately prior to bedtime. The remaining 11 days of the washout period constituted a drug holiday during which time no study medication was administered.
922770|NCT01021852|E5|Reported Event|MK-6096 20 mg|Participants received MK-6096 20 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922771|NCT01021852|E4|Reported Event|MK-6096 10 mg|Participants received MK-6096 10 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922772|NCT01021852|E3|Reported Event|MK-6096 5 mg|Participants received MK-6096 5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922773|NCT01021852|E2|Reported Event|MK-6096 2.5 mg|Participants received MK-6096 2.5 mg prior to bedtime for 4 weeks (Days 1-29) during a treatment period.
922774|NCT01021852|E1|Reported Event|Placebo|Participants received dose-matched placebo to MK-6096 prior to bedtime for 4 weeks (Days 1-29) during a treatment period. Placebo data were pooled across the four 2-period cross-overs within the study.
922775|NCT01021813|B3|Baseline|Total|Total of all reporting groups
922776|NCT01021813|B2|Baseline|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922777|NCT01021813|B1|Baseline|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922778|NCT01021813|P5|Participant Flow|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
922779|NCT01021813|P4|Participant Flow|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
922966|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
922783|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase. Following the Treatment Phase, these participants continued on placebo during the 2-month Randomized Discontinuation Phase.
922784|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase. Following the Treatment Phase, these participants were randomized (at baseline) to suvorexant or placebo during the 2-month Randomized Discontinuation Phase.
922785|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922786|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922787|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922788|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922866|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922789|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
922790|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
922791|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
922792|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
922793|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
922794|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
922795|NCT01021813|O3|Outcome|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Period, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
922796|NCT01021813|O2|Outcome|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received dose-matched placebo to suvorexant during a 2-month DB Discontinuation Period.
922797|NCT01021813|O1|Outcome|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Period, participants received their same dose of suvorexant during a 2-month DB Discontinuation Period.
922798|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922799|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922800|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922801|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922802|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922803|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922804|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922805|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922806|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922807|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
927901|NCT01010399|O1|Outcome|Boosted Lexiva With Lovaza|
922809|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922810|NCT01021813|O2|Outcome|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922811|NCT01021813|O1|Outcome|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922812|NCT01021813|E8|Reported Event|Placebo (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with dose-matched placebo during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
922813|NCT01021813|E7|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Run-out)/Follow-up|Following treatment with suvorexant during the 12-Month DB Treatment Period and treatment with dose-matched placebo during the DB the Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
922867|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922814|NCT01021813|E6|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Run-out)/Follow-up|Following treatment with suvorexant during both the 12-Month DB Treatment Period and the DB Run-out period, participants entered a Follow-up Phase which concluded with a follow-up phone call 14 days after the last dose of study medication (or 14 days after the Discontinuation visit, whichever time point was later) to report AEs.
922815|NCT01021813|E5|Reported Event|Placebo (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with dose-matched placebo to suvorexant during the 12-Month DB Treatment Phase, participants continued to receive dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
922816|NCT01021813|E4|Reported Event|Suvorexant (DB Treatment)/Placebo (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received dose-matched placebo to suvorexant during a 2-month DB Randomized Discontinuation Phase.
922817|NCT01021813|E3|Reported Event|Suvorexant (DB Treatment)/Suvorexant (DB Discontinuation)|Following treatment with suvorexant during the 12-Month DB Treatment Phase, participants received their same dose of suvorexant during a 2-month DB Randomized Discontinuation Phase.
922818|NCT01021813|E2|Reported Event|Placebo|After a 1-week single-blind placebo run-in, participants received dose-matched placebo to suvorexant (administered according to age) daily before bedtime for 12 months during the DB Treatment Phase.
922819|NCT01021813|E1|Reported Event|Suvorexant|After a 1-week single-blind placebo run-in, participants received suvorexant (40 mg for participants aged 18 to <65 years; and 30 mg for participants aged ≥65 years) daily before bedtime for 12 months during the double-blind (DB) Treatment Phase.
922820|NCT01021761|B4|Baseline|Total|Total of all reporting groups
922821|NCT01021761|B3|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
922822|NCT01021761|B2|Baseline|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922823|NCT01021761|B1|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922824|NCT01021761|P3|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
922825|NCT01021761|P2|Participant Flow|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922826|NCT01021761|P1|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922827|NCT01021761|O3|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
922828|NCT01021761|O2|Outcome|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922829|NCT01021761|O1|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922830|NCT01021761|E3|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery.
922831|NCT01021761|E2|Reported Event|Nevanac|Nevanac to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922832|NCT01021761|E1|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses pre op the day of surgery prior to surgery
922833|NCT01021683|B1|Baseline|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922834|NCT01021683|P1|Participant Flow|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922835|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
923227|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
922836|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922837|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922838|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922839|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
923250|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
922840|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922841|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922842|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922843|NCT01021683|O1|Outcome|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922844|NCT01021683|E1|Reported Event|Itraconazole|Participants who had been receiving itraconazole were observed prospectively. Itraconazole was administered as an infusion (a fluid or a medicine delivered into a vein by way of a needle) over one hour at the dose of 200 milligram (mg) per dose twice daily for 2 days, followed by 200 mg once daily for 12 days, and then itraconazole oral solution at the dose of 200 mg per dose twice daily for 14 days until clinically significant neutropenia was recovered.
922845|NCT01021618|B3|Baseline|Total|Total of all reporting groups
922846|NCT01021618|B2|Baseline|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
922847|NCT01021618|B1|Baseline|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
922848|NCT01021618|P2|Participant Flow|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
922849|NCT01021618|P1|Participant Flow|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
922850|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
922851|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
922852|NCT01021618|O2|Outcome|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
922853|NCT01021618|O1|Outcome|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
922854|NCT01021618|E2|Reported Event|Exercise-vasodilator Stress|Symptom-limited exercise followed by a bolus intravenous injection of regadenoson (0.4 mg/5 mL) only in patients failing to achieve a standard clinical endpoint
922855|NCT01021618|E1|Reported Event|Vasodilator-exercise Stress|Four-minute infusion of dipyridamole (0.56 mg/kg) followed by symptom-limited exercise.
922856|NCT01020526|B1|Baseline|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
922857|NCT01020526|P1|Participant Flow|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
922973|NCT01021111|O1|Outcome|Activity Training With Feedback|Subjects who underwent activity training with feedback
922858|NCT01020526|O1|Outcome|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
922859|NCT01020526|E1|Reported Event|Pregabalin|Participants initiated dosing at 75 mg/day and their dose was optimized over a 3 week period, based on tolerability and response, to a dose of 75 mg/day, 150 mg/day, 300 mg/day or 450 mg/day. These doses were administered during the subsequent flexible dosing phase for a period of 21 weeks. Pregabalin was administered orally as capsules.
922860|NCT01021423|B3|Baseline|Total|Total of all reporting groups
922861|NCT01021423|B2|Baseline|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922862|NCT01021423|B1|Baseline|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922863|NCT01021423|P2|Participant Flow|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922864|NCT01021423|P1|Participant Flow|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922865|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
923251|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
922868|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922869|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922870|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922871|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922872|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922873|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922874|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922875|NCT01021423|O2|Outcome|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922876|NCT01021423|O1|Outcome|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922877|NCT01021423|E2|Reported Event|Placebo|Placebo (identical matched capsule) orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922878|NCT01021423|E1|Reported Event|Lenalidomide|Lenalidomide - 15 mg orally once daily on Days 1-21 of every 28-day cycle for a maximum of 2 years or until disease progression, unacceptable toxicity develops or voluntary withdrawal.
922879|NCT01021332|B1|Baseline|Total Group|Participants who received at least one dose of open-label FDC treatment
922880|NCT01021332|P1|Participant Flow|Total Group|Participants who received at least one dose of open-label FDC treatment
922881|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922882|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922883|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922884|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922885|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922886|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922887|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922888|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922889|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
922890|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922891|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922892|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922893|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922894|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922895|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922896|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922897|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922898|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922899|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922900|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922901|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057).
922902|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922903|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922904|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922905|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922906|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922907|NCT01021332|O1|Outcome|Total Group|Participants who received the open-label FDC treatment and were included in the Full Analysis Set of 905-CL-057
922909|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
922910|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
922911|NCT01021332|O1|Outcome|Total Group|Participants who received at least one dose of open-label FDC treatment
922912|NCT01021332|E1|Reported Event|Total Group|Participants who received at least one dose of open-label FDC treatment
922913|NCT01021306|B5|Baseline|Total|Total of all reporting groups
922914|NCT01021306|B4|Baseline|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
922915|NCT01021306|B3|Baseline|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
922916|NCT01021306|B2|Baseline|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
922917|NCT01021306|B1|Baseline|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
922918|NCT01021306|P4|Participant Flow|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
922919|NCT01021306|P3|Participant Flow|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
922967|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
922920|NCT01021306|P2|Participant Flow|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
922921|NCT01021306|P1|Participant Flow|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
922922|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
922923|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
922924|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
922925|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
922926|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
922927|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
922928|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
922968|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
923021|NCT01020903|O2|Outcome|Placebo|Placebo: Orally, pre-op
922929|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
922930|NCT01021306|O4|Outcome|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
922931|NCT01021306|O3|Outcome|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
922947|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
951233|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
922932|NCT01021306|O2|Outcome|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
922933|NCT01021306|O1|Outcome|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
922934|NCT01021306|E4|Reported Event|Self-care Only Group|"All patients will be offered the self-care checklist of homecare approaches at baseline. Self-care only participants successfully completing the 6 months assessment will be given the option for RIST or AMCT for one month.~Self-Care Only Group: Self care consists of an initial set of standard patient self performed treatments which will include jaw relaxation exercises, reduction of parafunction, thermal packs, low dose NSAIDs, passive opening stretches and suggestions for stress reduction."
922935|NCT01021306|E3|Reported Event|Sham AMCT & Self Care|"This protocol will attempt to follow all of the procedures of the actual AMCT protocol except no thrust will be delivered. Self-care only participants successfully completing the 6 month assessment will be given the option for RIST or AMCT for one month.~Sham AMCT: This protocol will attempt to follow all of the procedures of the actual AMCT protocol except that when a thrust is given with the Activator instrument, the clinician will place the thumb of his left hand over the spot that would normally be adjusted. The tip of the instrument them will be placed very close to, but not touching the thumb. Consequently, the patient will feel the contact of the clinician's thumb on the spot that would be normally adjusted, and will hear the click of the instrument, but no thrust will be delivered to the patient."
922936|NCT01021306|E2|Reported Event|Dental Care & Self Care|"Intraoral splints are removable orthopedic appliances made of acrylic resin positioned between remaining teeth and designed in theory to support function of the TMJ and relieve pain. Stabilization splints are believed to function by stabilizing intracapsular structure of TMJ, reducing activity of masticatory muscles, distributing occlusal forces, and reducing bruxism (teeth grinding).~Dental Care & Self Care: Following dental exam, patients will have maxillary and mandibular polyvinyl siloxane impressions. Interocclusal records will be made with a fast setting silicone using a metal tray. Commercial laboratory will wax and heat process acrylic resin splint to capture mandibular cusp tips in the occlusal plan of splint. Splint will be adjusted to provide uniform posterior centric occlusal stops followed by evaluation for canine guidance. Splint will be polished and home care instruction provided. Patients will be i"
922969|NCT01021215|E2|Reported Event|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
922970|NCT01021215|E1|Reported Event|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
922971|NCT01021111|B1|Baseline|Activity Training With Feedback|Subjects who underwent activity training with feedback
922972|NCT01021111|P1|Participant Flow|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities~Anterior Cruciate Ligament Measurement and Feedback System"
923022|NCT01020903|O1|Outcome|Aprepitant|Aprepitant: 40 mg po pre-op
922937|NCT01021306|E1|Reported Event|Chiropractic w/Activator & Self Care|"This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner.~Chiropractic w/Activator & Self Care: This technique uses a hand held instrument to deliver a quick, shallow thrust in a well defined manner. The instrument has two handles that are squeezed together until it clicks, resulting in a shallow, very quick thrust to the segment that is to be adjusted. The AMCT protocol is a structured method of chiropractic treatment that utilized a number of simple biomechanical tests in order to determine where to adjust. These tests are mostly well defined movements of body parts such as extending the head or laterally moving the mandible relative to the rest of the skull. This protocol includes treatment of the full spine and appendages as well as the area immediately around the jaw."
922938|NCT01021293|B3|Baseline|Total|Total of all reporting groups
922939|NCT01021293|B2|Baseline|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922940|NCT01021293|B1|Baseline|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922941|NCT01021293|P2|Participant Flow|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922942|NCT01021293|P1|Participant Flow|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922943|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) vaccine at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922944|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922945|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922946|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
951234|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
922948|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922949|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922950|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922951|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922952|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922953|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922954|NCT01021293|O2|Outcome|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922955|NCT01021293|O1|Outcome|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922956|NCT01021293|E2|Reported Event|Control Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Oral Poliomyelitis Vaccine (OPV) at 2, 3 and 4 months of age, according to the vaccination policy recommended in China.
922957|NCT01021293|E1|Reported Event|Poliorix Group|Healthy male and female Chinese infants between, and including 60 and 90 days of age, who received 3 doses of Poliorix™ (IPV) vaccine at 2, 3 and 4 months of age, administered intramuscularly into the anterolateral side of the right thigh.
922958|NCT01021215|B3|Baseline|Total|Total of all reporting groups
922959|NCT01021215|B2|Baseline|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
922960|NCT01021215|B1|Baseline|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
922961|NCT01021215|P2|Participant Flow|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
922962|NCT01021215|P1|Participant Flow|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
922963|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
922964|NCT01021215|O1|Outcome|Arm I: Zileuton|Zileuton 1200 mg twice orally twice a day on days 1-6.
922965|NCT01021215|O2|Outcome|Arm II: Zileuton and Celecoxib|Combined Zileuton 1200 mg twice daily plus Celecoxib 200 mg twice daily on days 1-6.
923228|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
922974|NCT01021111|O1|Outcome|Activity Training With Feedback|Subjects who underwent activity training with feedback
922975|NCT01021111|E1|Reported Event|Activity Training With Feedback|"Subject is tested prior to training and retested with feedback training designed to modify the mechanics of landing during jumping and running activities~Anterior Cruciate Ligament Measurement and Feedback System"
922976|NCT01021020|B1|Baseline|Colchicine(Fasted),Colchicine(Fed),Colchicine/Probenecid|All subjects received all study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
922977|NCT01021020|P1|Participant Flow|Colchicine (Fasted),Colchicine (Fed),Colchicine/Probenecid|All subjects received each of the three study treatments in a randomly assigned sequence of dosing periods. On the morning of Days 1, 15, and 29, each subject received one of the following three treatments: 1) one tablet of colchicine 0.6 mg after an overnight fast of at least 13.5 hours, 2) one tablet of colchicine 0.6 mg after a high-fat breakfast, or 3) one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast of at least 13.5 hours.
922978|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
922979|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
922980|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
922981|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasting)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast
922982|NCT01021020|O2|Outcome|Colchicine 0.6 mg (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
922983|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasting)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
922984|NCT01021020|O3|Outcome|Colchicine 0.5 mg/ Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg following an overnight fast.
922985|NCT01021020|O2|Outcome|Colchicine (High-fat Meal)|Subjects received one tablet of colchicine 0.6 mg after a high-fat breakfast.
922986|NCT01021020|O1|Outcome|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6 mg after an overnight fast.
922987|NCT01021020|E3|Reported Event|Colchicine 0.5 mg/Probenecid 500 mg (Fasted)|Subjects received one tablet of colchicine 0.5 mg/ probenecid 500 mg after an overnight fast of at least 13.5 hours.
922988|NCT01021020|E2|Reported Event|Colchicine 0.6 mg (Fed)|Subjects received one tablet of colchicine 0.6 mg after a high-fat meal.
922989|NCT01021020|E1|Reported Event|Colchicine 0.6 mg (Fasted)|Subjects received one tablet of colchicine 0.6mg after an overnight fast of at least 13.5 hours.
922990|NCT01021007|B3|Baseline|Total|Total of all reporting groups
922991|NCT01021007|B2|Baseline|Iocide Mouthrinse|Experimental mouthrinse
922992|NCT01021007|B1|Baseline|Negative Control Rinse|Placebo mouthrinse
922993|NCT01021007|P2|Participant Flow|Iocide Mouthrinse|Experimental mouthrinse
922994|NCT01021007|P1|Participant Flow|Negative Control Rinse|Placebo mouthrinse
922995|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
922996|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
922997|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
922998|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
922999|NCT01021007|O2|Outcome|Iocide Mouthrinse|Experimental mouthrinse
923000|NCT01021007|O1|Outcome|Negative Control Rinse|Placebo mouthrinse
923001|NCT01021007|E2|Reported Event|Iocide Mouthrinse|Experimental mouthrinse
923002|NCT01021007|E1|Reported Event|Negative Control Rinse|Placebo mouthrinse
923003|NCT01020981|B3|Baseline|Total|Total of all reporting groups
923004|NCT01020981|B2|Baseline|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923005|NCT01020981|B1|Baseline|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923006|NCT01020981|P2|Participant Flow|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923007|NCT01020981|P1|Participant Flow|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923008|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
923009|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
923010|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
923011|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments after December 2008
923012|NCT01020981|O2|Outcome|Indiana Army National Guard|Indiana Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923013|NCT01020981|O1|Outcome|Michigan Army National Guard|Michigan Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923014|NCT01020981|E2|Reported Event|Indiana Army National Guard|Indiana State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923015|NCT01020981|E1|Reported Event|Michigan Army National Guard|Michigan State Army National Guard soldiers who have returned from OEF/OIF deployments starting December 2008
923016|NCT01020903|B3|Baseline|Total|Total of all reporting groups
923017|NCT01020903|B2|Baseline|Placebo|Placebo: Orally, pre-op
923018|NCT01020903|B1|Baseline|Aprepitant|Aprepitant: 40 mg po pre-op
923019|NCT01020903|P2|Participant Flow|Placebo|Placebo: Orally, pre-op
923020|NCT01020903|P1|Participant Flow|Aprepitant|Aprepitant: 40 mg po pre-op
923023|NCT01020903|E2|Reported Event|Placebo|"Placebo: Orally, pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
923024|NCT01020903|E1|Reported Event|Aprepitant|"Aprepitant: 40 mg po pre-op Please be advised that the investigator of the study entitled Aprepitant for Post-operative Nausea NCT01020903 left the institution in 2011. Normally, to update this record in clinicaltrial.gov, we would go to the IRB records. However, the IRB records of the reviewing IRB (Staten Island University Hospital IRB) were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records."
923025|NCT01020877|B3|Baseline|Total|Total of all reporting groups
923026|NCT01020877|B2|Baseline|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
923027|NCT01020877|B1|Baseline|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
923028|NCT01020877|P2|Participant Flow|Reference (MetroGel-Vaginal®) First|0.75% MetroGel-Vaginal® reference product dosed in first period followed by 0.75% Metronidazole Vaginal Gel test product dosed in the second period.
923252|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923029|NCT01020877|P1|Participant Flow|Test (Metronidazole) First|0.75% Metronidazole Vaginal Gel test product dosed in first period followed by 0.75% MetroGel-Vaginal® reference product dosed in the second period.
923030|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
923031|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
923032|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
923033|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
923034|NCT01020877|O2|Outcome|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
923035|NCT01020877|O1|Outcome|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
923036|NCT01020877|E2|Reported Event|Reference (MetroGel-Vaginal®)|0.75% MetroGel-Vaginal® reference product dosed in either period.
923037|NCT01020877|E1|Reported Event|Test (Metronidazole)|0.75% Metronidazole Vaginal Gel test product dosed in either period.
923038|NCT01020838|B1|Baseline|Safety Analysis Set|All study participants who received any amount of florbetaben were included in the safety analysis set.
923039|NCT01020838|P1|Participant Flow|All Study Participants|All patients enrolling into the study
923040|NCT01020838|O3|Outcome|2nd Repeat Drug Administration|The analysis set consisted of data from 3 subjects with brain specimens available.
923041|NCT01020838|O2|Outcome|1st Repeat Drug Administration|The analysis set consisted of data from 20 subjects with brain specimens available.
923042|NCT01020838|O1|Outcome|Initial Drug Administration|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Descriptive statistics of subject level Composite SUVR by SOT for baseline scans and last available scans are reported.
923043|NCT01020838|O2|Outcome|Specificity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Specificity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
923044|NCT01020838|O1|Outcome|Sensitivity of Subject Level Composite SUVR by SOT|The analysis set consisted of data from 96 subjects, including 86 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT). Sensitivity of subject level composite SUVR by SOT for baseline scans and last available scans are reported.
923045|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
923046|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
923047|NCT01020838|O1|Outcome|Full Analysis Set Final Clinical Study Report|The full analysis of the final clinical study report consisted of data from 97 subjects, including 87 subjects with brain specimens and 10 young healthy controls considered to be β-amyloid-negative as a valid Standard of Truth (SOT).
923048|NCT01020838|O2|Outcome|Specificity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
923049|NCT01020838|O1|Outcome|Sensitivity (Interim Analysis Set)|The full analysis set consisted of 31 subjects for whom both brain specimen with a valid Standard of Truth (SOT) in at least one brain region and a florbetaben PET scan were available and 10 healthy controls for whom a florbetaben PET scan was available and whose SOT was considered β-amyloid negative by definition.
923050|NCT01020838|E3|Reported Event|2nd Repeat Drug Administration|Subjects with TEAEs within 7 days of the 2nd repeat drug administration.
923051|NCT01020838|E2|Reported Event|1st Repeat Drug Administration|Subjects with TEAEs within 7 days of the 1st repeat drug administration.
923052|NCT01020838|E1|Reported Event|Initial Drug Administration|Subjects with TEAEs within 7 days of the initial administration of florbetaben.
923085|NCT01020799|E3|Reported Event|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923053|NCT01020812|B1|Baseline|Stereotactic Body Radiotherapy (SBRT)|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
923054|NCT01020812|P1|Participant Flow|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
923055|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
923111|NCT01020747|O2|Outcome|Untreated Vocal Fold|Subjects received saline injections in combination with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the less diseased vocal fold.
923253|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
951235|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
923056|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
923057|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
923058|NCT01020812|O1|Outcome|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
923059|NCT01020812|E1|Reported Event|SBRT and TACE|"SBRT will be delivered on Varian's linear accelerator with On-Board Imaging (OBI) capabilities. The tumor will be tracked with the ethiodol material from the TACE procedure, and respiratory gating will be used to minimize motion due to respiration. Treatment will be given in either 3 or 5 fractions . SBRT will take place after the treatment planning and within 12 weeks of the last TACE procedure.~Doses: 45 Gy at 15 Gy/fraction , 36 Gy at 12 Gy/fraction, 45 Gy at 9 Gy/fraction, 40 Gy at 8 Gy/fraction~TACE: Standard of Care~SBRT: Standard of Care"
923060|NCT01020799|B4|Baseline|Total|Total of all reporting groups
923061|NCT01020799|B3|Baseline|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923062|NCT01020799|B2|Baseline|Placebo|Placebo matching both AZD7268 and escitalopram
923063|NCT01020799|B1|Baseline|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923064|NCT01020799|P3|Participant Flow|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923065|NCT01020799|P2|Participant Flow|Placebo|Placebo matching both AZD7268 and escitalopram
923066|NCT01020799|P1|Participant Flow|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923067|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923068|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
923069|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923070|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923071|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
923072|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923073|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923074|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
923075|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923076|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923077|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
923078|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923079|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923080|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
923081|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923082|NCT01020799|O3|Outcome|Escitalopram|Escitalopram 20 mg once per day(QD) Placebo matching AZD7268
923083|NCT01020799|O2|Outcome|Placebo|Placebo matching both AZD7268 and escitalopram
923084|NCT01020799|O1|Outcome|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
927902|NCT01010399|E1|Reported Event|Boosted Lexiva With Lovaza|
923087|NCT01020799|E1|Reported Event|AZD7268|AZD7268 15 mg twice per day (BID), placebo matching escitalopram
923088|NCT01020786|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923089|NCT01020786|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923090|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923247|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923091|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923092|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923093|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923094|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923095|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923096|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923097|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923098|NCT01020786|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m2) of pemetrexed given intravenously (IV) on Day 1 of every 21 day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 for participant, given IV on Day 1 of every 21 day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m2 of pemetrexed given IV on Day 1 of every 21 day cycle until disease progression or unacceptable toxicity."
923099|NCT01020786|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy period (Pemetrexed + carboplatin): 500 milligrams per square meter (mg/m^2) of pemetrexed given intravenously (IV) on Day 1 of every 21-day cycle for 4 cycles.~Carboplatin: dosage equal to the area under the curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) for participant, given IV on Day 1 of every 21-day cycle for 4 cycles.~Maintenance therapy period (pemetrexed monotherapy): 500 mg/m^2 of pemetrexed given IV on Day 1 of every 21-day cycle until disease progression or unacceptable toxicity."
923100|NCT01020773|B3|Baseline|Total|Total of all reporting groups
923101|NCT01020773|B2|Baseline|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
923229|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923102|NCT01020773|B1|Baseline|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
923103|NCT01020773|P2|Participant Flow|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
923104|NCT01020773|P1|Participant Flow|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
923105|NCT01020773|O2|Outcome|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
923106|NCT01020773|O1|Outcome|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
923107|NCT01020773|E2|Reported Event|No-SBT Group|In no-SBT group, as soon as a patient met readiness criteria, he or she underwent extubation without SBT process.
923108|NCT01020773|E1|Reported Event|SBT Group|In the Spontaneous Breathing Trial(SBT) group, the patients underwent a 1 hr SBT with Inspiratory Support Pressure(PS) of 7 cmH2O with other settings remaining constant (FiO2, PEEP, trigger sensitivity). The patients who tolerated the SBT underwent immediate extubation.
923109|NCT01020747|B1|Baseline|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
923110|NCT01020747|P1|Participant Flow|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
923112|NCT01020747|O1|Outcome|Bevacizumab Treated Vocal Fold|Subjects received injections of bevacizumab in conjunction with Potassium-Titanyl-Phosphate (KTP)laser photoangiolysis in the more diseased vocal fold.
923113|NCT01020747|E1|Reported Event|Group Avastin|Subjects received Avastin in the more diseased vocal fold and saline in the other.
923114|NCT01020591|B3|Baseline|Total|Total of all reporting groups
923115|NCT01020591|B2|Baseline|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
923116|NCT01020591|B1|Baseline|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
923117|NCT01020591|P2|Participant Flow|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
923118|NCT01020591|P1|Participant Flow|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
923119|NCT01020591|O4|Outcome|Post Test to Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
923120|NCT01020591|O3|Outcome|Same Day Post Test to Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
923121|NCT01020591|O2|Outcome|Pre Test to the Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
923122|NCT01020591|O1|Outcome|Pre Test to the Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
923123|NCT01020591|E2|Reported Event|Osteopathic Evaluation With Treatment|osteopathic evaluation of motion and tissue mobility followed by osteopathic manual therapy release of the tight or restricted tissues
923124|NCT01020591|E1|Reported Event|Osteopathic Evaluation|osteopathic evaluation: forward flexion test, hip drop test, the sitting forward flexion test, sitting diaphragm evaluation, sphenobasilar symphysis (SBS) listening, sacral listening, pelvic floor evaluation, peritoneal bag evaluation and global femoral artery evaluation
923125|NCT01020487|B4|Baseline|Total|Total of all reporting groups
923126|NCT01020487|B3|Baseline|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923127|NCT01020487|B2|Baseline|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923128|NCT01020487|B1|Baseline|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
923129|NCT01020487|P3|Participant Flow|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923130|NCT01020487|P2|Participant Flow|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923131|NCT01020487|P1|Participant Flow|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
923132|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923133|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923134|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923135|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923136|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923248|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923249|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923137|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923138|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923139|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923140|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923141|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923142|NCT01020487|O2|Outcome|Part 2: Paricalcitol|Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels.
923143|NCT01020487|O1|Outcome|Part 2: Placebo|Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels.
923144|NCT01020487|O1|Outcome|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
923145|NCT01020487|O1|Outcome|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
923146|NCT01020487|E5|Reported Event|Part 2: Paricalcitol/Paricalcitol|Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24).
923147|NCT01020487|E4|Reported Event|Part 2: Placebo/Paricalcitol|Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels.
923148|NCT01020487|E3|Reported Event|Part 2: Paricalcitol|Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels.
923149|NCT01020487|E2|Reported Event|Part 2: Placebo|Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase.
923150|NCT01020487|E1|Reported Event|Part 1: Paricalcitol|Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1.
923151|NCT01020474|B3|Baseline|Total|Total of all reporting groups
923152|NCT01020474|B2|Baseline|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923153|NCT01020474|B1|Baseline|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923154|NCT01020474|P2|Participant Flow|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923155|NCT01020474|P1|Participant Flow|Pregabalin|Pregabalin was administered orally, BID (twice a day) for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 milligram per day (mg/day) to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923156|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923157|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923158|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923159|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923160|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923161|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923162|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923163|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923164|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923165|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923166|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923167|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923168|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923169|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923170|NCT01020474|O2|Outcome|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923171|NCT01020474|O1|Outcome|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923172|NCT01020474|E2|Reported Event|Placebo|Placebo was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Dosing was started on Day 1.
923173|NCT01020474|E1|Reported Event|Pregabalin|Pregabalin was administered orally, BID for 15 weeks (3 week dose optimization phase and 12 week fixed-dose phase). Participants received 75 mg/day to 450 mg/day. Dosing was started on Day 1. The dose was optimized over a 3-week period followed by an additional 12 weeks at the optimized dose.
923174|NCT01020448|B1|Baseline|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
923175|NCT01020448|P1|Participant Flow|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
923176|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
923177|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
923178|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
923179|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
923180|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
923181|NCT01020448|O1|Outcome|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.
923182|NCT01020448|E1|Reported Event|Triptorelin (Decapeptyl®) 22.5 mg|Triptorelin (Decapeptyl®): One intramuscular injection of triptorelin (Decapeptyl®) 22.5 mg performed once all baseline procedures and assessments have been completed.
923183|NCT01020305|B1|Baseline|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
923184|NCT01020305|P1|Participant Flow|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
923185|NCT01020305|O1|Outcome|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
923186|NCT01020305|E1|Reported Event|Temsirolimus + Bicalutamide|"Temsirolimus 25 mg administered intravenously (IV) once weekly for 12 weeks~Casodex (bicalutamide) administered 50 mg/day orally (PO)~Temsirolimus: Temsirolimus is an inhibitor of the mammalian target of rapamycin (MTOR, aka HGNC:3942)~IUPAC name: (1R,2R,4S)-4-{(2R)-2-[(3S,6R,7E,9R,10R,12R,14S,15E,17E,19E,21S,23S,26R,27R,34aS)-9,27-dihydroxy-10,21-dimethoxy-6,8,12,14,20,26-hexamethyl-1,5,11,28,29-pentaoxo-1,4,5,6,9,10,11,12,13,14,21,22,23,24,25,26,27,28,29,31,32,33,34,34a-tetracosahydro-3H-23,27-epoxypyrido[2,1-c][1,4]oxazacyclohentriacontin-3-yl]propyl}-2-methoxycyclohexyl 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoate~Casodex (bicalutamide): Casodex (bicalutamide) 50 mg/day PO"
923187|NCT01020123|B8|Baseline|Total|Total of all reporting groups
923188|NCT01020123|B7|Baseline|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923189|NCT01020123|B6|Baseline|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923190|NCT01020123|B5|Baseline|Placebo|Placebo add on to metformin
923191|NCT01020123|B4|Baseline|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923192|NCT01020123|B3|Baseline|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923193|NCT01020123|B2|Baseline|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923194|NCT01020123|B1|Baseline|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923195|NCT01020123|P7|Participant Flow|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923196|NCT01020123|P6|Participant Flow|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923197|NCT01020123|P5|Participant Flow|Placebo|Placebo add on to metformin
923198|NCT01020123|P4|Participant Flow|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923199|NCT01020123|P3|Participant Flow|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923200|NCT01020123|P2|Participant Flow|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923201|NCT01020123|P1|Participant Flow|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923202|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923203|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923204|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923205|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923206|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923207|NCT01020123|O5|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923208|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923209|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923210|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923211|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923212|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923213|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923214|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923215|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923216|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923217|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923218|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923219|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923220|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923221|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923222|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923223|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923224|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923225|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923226|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923424|NCT01019928|B3|Baseline|Total|Total of all reporting groups
923230|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923231|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923232|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923233|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923234|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923235|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923236|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923237|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923238|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923239|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923240|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923241|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923242|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923243|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923244|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923245|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923246|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923254|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923255|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923256|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923257|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923258|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923259|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923260|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923261|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923262|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923263|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923264|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923265|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923266|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923267|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923268|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923269|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923270|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923271|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923272|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923273|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923274|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923275|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923276|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923277|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923278|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923279|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923280|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923281|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923282|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923283|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923284|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923285|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923286|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923287|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923288|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923289|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923290|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923291|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923292|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923293|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923294|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923295|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923296|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923297|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923298|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923299|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923300|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923301|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923302|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923303|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923425|NCT01019928|B2|Baseline|Placebo|
923304|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923305|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923306|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923307|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923308|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923309|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923310|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923311|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923312|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923313|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923314|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923315|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923316|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923317|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923318|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923319|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923320|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923452|NCT01019928|O1|Outcome|AZD1386 95 mg|
923321|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923322|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923323|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923324|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923325|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923326|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923327|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923328|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923329|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923330|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923331|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923332|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923333|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923334|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923335|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923336|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923337|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923338|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923339|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923340|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923341|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923342|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923343|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923344|NCT01020123|O7|Outcome|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923345|NCT01020123|O6|Outcome|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923346|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923347|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923348|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923349|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923350|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923351|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923352|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923353|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923354|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923355|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923356|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923357|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923358|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923359|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923360|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923361|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923362|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923363|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923364|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923365|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923366|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923367|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923368|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923369|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923370|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923371|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923372|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923373|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923374|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923375|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923376|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923377|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923378|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923379|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923380|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923381|NCT01020123|O5|Outcome|Placebo|Placebo add on to metformin
923382|NCT01020123|O4|Outcome|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923383|NCT01020123|O3|Outcome|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923384|NCT01020123|O2|Outcome|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923385|NCT01020123|O1|Outcome|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923386|NCT01020123|E7|Reported Event|Open Label|Open label, 20-200 mg AZD1656 add on to metformin, titrated dose
923387|NCT01020123|E6|Reported Event|Glipizide|5-20 mg Glipizide add on to metformin, titrated dose
923388|NCT01020123|E5|Reported Event|Placebo|Placebo add on to metformin
923453|NCT01019928|O2|Outcome|Placebo|
923389|NCT01020123|E4|Reported Event|20 mg Fixed Dose|20 mg AZD1656 add on to metformin, fixed dose
923390|NCT01020123|E3|Reported Event|40 mg Fixed Dose|40 mg AZD1656 add on to metformin, fixed dose
923391|NCT01020123|E2|Reported Event|Lower Dose|10-140 mg AZD1656 add on to metformin, titrated dose
923392|NCT01020123|E1|Reported Event|Higher Dose|20-200 mg AZD1656 add on to metformin, titrated dose
923393|NCT01020019|B3|Baseline|Total|Total of all reporting groups
923394|NCT01020019|B2|Baseline|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
923395|NCT01020019|B1|Baseline|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
923396|NCT01020019|P2|Participant Flow|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
923397|NCT01020019|P1|Participant Flow|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
923398|NCT01020019|O2|Outcome|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
923399|NCT01020019|O1|Outcome|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
923400|NCT01020019|E2|Reported Event|Lofexidine and Dronabinol|"Maintained at 1.8mg/day Lofex. and 60 mg/day of Dronabinol~Lofexidine and Dronabinol: Lofex: .6 mg/ TID Dronabinol: 20 mg/TID"
923401|NCT01020019|E1|Reported Event|Placebo|"Lofex. matched placebo Dronabinol placebo~Placebo: Placebo control"
923402|NCT01020006|B4|Baseline|Total|Total of all reporting groups
923403|NCT01020006|B3|Baseline|Gemcitabine/Part B|
923404|NCT01020006|B2|Baseline|(PCI-27483 + Gemcitabine)/Part B|
923405|NCT01020006|B1|Baseline|(PCI-27483 + Gemcitabine)/Part A|
923406|NCT01020006|P3|Participant Flow|Gemcitabine/Part B|Subjects in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.
923407|NCT01020006|P2|Participant Flow|PCI-27483 + Gemcitabine/Part B|Part B is a randomized arm to evaluate safety and efficacy. Subjects received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.
923408|NCT01020006|P1|Participant Flow|PCI-27483 + Gemcitabine/Part A|Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, subjects received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.
923409|NCT01020006|O3|Outcome|Gemcitabine/Part B|
923410|NCT01020006|O2|Outcome|(PCI-27483 + Gemcitabine)/Part B|
923411|NCT01020006|O1|Outcome|(PCI-27483 + Gemcitabine)/Part A|
923412|NCT01020006|E3|Reported Event|Gemcitabine/Part B|"Patients in this arm of Part B received Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
923413|NCT01020006|E2|Reported Event|(PCI-27483 + Gemcitabine)/Part B|"Part B is a randomized arm to evaluate safety and efficacy. Patients received PCI-27483 at 1.2 mg/kg BID and Gemcitabine 1000 mg/m2 weekly intravenous infusion.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
923414|NCT01020006|E1|Reported Event|(PCI-27483 + Gemcitabine)/Part A|"Part A is a nonrandomized dose escalation arm. Subjects received PCI-27483 0.8 mg/kg BID as initial dose and may be escalated to 1.2, and 1.5 mg/kg BID. At the same time, patients received Gemcitabine 1000 mg/m2 weekly intravenous infusion on 3 out of every 4 weeks.~All treated subjects in this group experienced at least one treatment-emergent adverse event."
923415|NCT01019980|B3|Baseline|Total|Total of all reporting groups
923416|NCT01019980|B2|Baseline|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
923417|NCT01019980|B1|Baseline|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
923418|NCT01019980|P2|Participant Flow|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
923419|NCT01019980|P1|Participant Flow|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
923420|NCT01019980|O2|Outcome|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
923421|NCT01019980|O1|Outcome|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
923422|NCT01019980|E2|Reported Event|Acetaminophen|This study was cancelled. No patients were enrolled in this group.
923423|NCT01019980|E1|Reported Event|Diclofenac Potassium|This study was cancelled. Two patients were enrolled, but neither received drug as it was not available in the region
923427|NCT01019928|P2|Participant Flow|First Placebo, Then Washout, Then AZD1386|
923428|NCT01019928|P1|Participant Flow|First AZD1386, Then Washout, Then Placebo|
923429|NCT01019928|O2|Outcome|Placebo|
923430|NCT01019928|O1|Outcome|AZD1386 95 mg|
923431|NCT01019928|O2|Outcome|Placebo|
923432|NCT01019928|O1|Outcome|AZD1386 95 mg|
923433|NCT01019928|O2|Outcome|Placebo|
923434|NCT01019928|O1|Outcome|AZD1386 95 mg|
923435|NCT01019928|O2|Outcome|Placebo|
923436|NCT01019928|O1|Outcome|AZD1386 95 mg|
923437|NCT01019928|O2|Outcome|Placebo|
923438|NCT01019928|O1|Outcome|AZD1386 95 mg|
923439|NCT01019928|O2|Outcome|Placebo|
923440|NCT01019928|O1|Outcome|AZD1386 95 mg|
923441|NCT01019928|O2|Outcome|Placebo|
923442|NCT01019928|O1|Outcome|AZD1386 95 mg|
923443|NCT01019928|O2|Outcome|Placebo|
923444|NCT01019928|O1|Outcome|AZD1386 95 mg|
923445|NCT01019928|O2|Outcome|Placebo|
923446|NCT01019928|O1|Outcome|AZD1386 95 mg|
923447|NCT01019928|O2|Outcome|Placebo|
923448|NCT01019928|O1|Outcome|AZD1386 95 mg|
923449|NCT01019928|O2|Outcome|Placebo|
923450|NCT01019928|O1|Outcome|AZD1386 95 mg|
923451|NCT01019928|O2|Outcome|Placebo|
923467|NCT01019707|B1|Baseline|Total Sample|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine and placebo. The order of study drug was determined randomly.
923468|NCT01019707|P2|Participant Flow|Placebo, Then Atomoxetine|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under placebo for 15 days and then atomoxetine for 9 days after a 14 day wash out. The order of study drug was determined randomly.
923469|NCT01019707|P1|Participant Flow|Atomoxetine, Then Placebo|In this double-blind, within-subject crossover clinical trial, subjects received MA infusion and saline infusions under atomoxetine for 15 days and then placebo for 9 days after a 14 day wash out. The order of study drug was determined randomly.
923470|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
923471|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
923472|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
923473|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
923474|NCT01019707|O2|Outcome|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
923475|NCT01019707|O1|Outcome|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received up to 30mg MA during one study day per medication condition.
923476|NCT01019707|E2|Reported Event|Placebo With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
923477|NCT01019707|E1|Reported Event|Atomoxetine With MA|Based on random assignment, study drug will be administered once daily at 40 mg/day on the first 2 study days, then twice daily for the third, fourth and fifth study days, and once daily on the sixth study day. Subjects received infusions of saline and 30mg MA on one study day per medication condition.
923478|NCT01019694|B4|Baseline|Total|Total of all reporting groups
923479|NCT01019694|B3|Baseline|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923480|NCT01019694|B2|Baseline|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923481|NCT01019694|B1|Baseline|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923482|NCT01019694|P3|Participant Flow|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923483|NCT01019694|P2|Participant Flow|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923484|NCT01019694|P1|Participant Flow|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923485|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923486|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923487|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923488|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923489|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923490|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923491|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923492|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923493|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923494|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923495|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923496|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923497|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923498|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923499|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923500|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923501|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923502|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923503|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923504|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923505|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
924356|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
923506|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923507|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923508|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923509|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923510|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923511|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923512|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923513|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923514|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923515|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923516|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923517|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923518|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923519|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923520|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923521|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923522|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923523|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923524|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923525|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923526|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923527|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923528|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923529|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923530|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923531|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923532|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923533|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923534|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923535|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923536|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923537|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923538|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923539|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923540|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923541|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923542|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923543|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923544|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923545|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923546|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923547|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923548|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923549|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923550|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923551|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923552|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923553|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923554|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923555|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923556|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923557|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923558|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923559|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923560|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923561|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923562|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923563|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923564|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923565|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923566|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923567|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923568|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923569|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923570|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923571|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923572|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923573|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923574|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923575|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923576|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923577|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923578|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923579|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923580|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923581|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923582|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923583|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923584|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923585|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923586|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923587|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923588|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923589|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923590|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923591|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923592|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923593|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923594|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923595|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923596|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923597|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923598|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923599|NCT01019694|O3|Outcome|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923600|NCT01019694|O2|Outcome|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923601|NCT01019694|O1|Outcome|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923602|NCT01019694|E3|Reported Event|Atrovent + Albuterol Aerosols|ipratropium bromide 34 mcg, albuterol sulfate 180 mcg qid
923603|NCT01019694|E2|Reported Event|Combivent Inhalation Aerosol|ipratropium bromide and albuterol sulfate 36/206 mcg qid
923604|NCT01019694|E1|Reported Event|Combivent Respimat|ipratropium/albuterol 20/100 micrograms (mcg) 4 per day (qid)
923606|NCT01019486|B3|Baseline|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
923607|NCT01019486|B2|Baseline|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
923608|NCT01019486|B1|Baseline|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
923609|NCT01019486|P3|Participant Flow|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
923610|NCT01019486|P2|Participant Flow|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
923611|NCT01019486|P1|Participant Flow|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
923612|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
923613|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
923614|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
923655|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923656|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923615|NCT01019486|O1|Outcome|Abnormal MPI Study|These subjects demonstrated abnormal radionuclide myocardial perfusion imaging studies with perfusion defects in response to regadenoson stress. The perfusion defect qualified the subject to participated in invasive CFR measurements. Coronary arteries within the region of the perfusion defect were cannulated for CFR measurements. Flow measurements were performed in the 2 normal vessels and the abnormal vessel both at rest and following regadenoson administration to calculated CFR values..
923616|NCT01019486|O3|Outcome|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
923617|NCT01019486|O2|Outcome|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
923618|NCT01019486|O1|Outcome|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
923619|NCT01019486|E3|Reported Event|Type 1 Diabetes High Risk Group|Subjects with T1DM for at least 10 years and CAC > or = 100
923620|NCT01019486|E2|Reported Event|Type 1 Diabetes Low Risk Group|Subjects with T1DM for at least 10 years and CAC < 100
923621|NCT01019486|E1|Reported Event|Non Diabetic Controls|Subjects with Coronary Artery Calcium (CAC score> 100 in the CACTI Stdy)
923622|NCT01019369|B3|Baseline|Total|Total of all reporting groups
923623|NCT01019369|B2|Baseline|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923624|NCT01019369|B1|Baseline|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923625|NCT01019369|P2|Participant Flow|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923626|NCT01019369|P1|Participant Flow|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923627|NCT01019369|O2|Outcome|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923628|NCT01019369|O1|Outcome|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923629|NCT01019369|E2|Reported Event|Clinic Administration of DMPA|"Clinic administration (routine care) of DMPA~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923630|NCT01019369|E1|Reported Event|Self Administration of DMPA|"Self administration of subcutaneous (SC) DMPA (depot medroxyprogesterone acetate)~Medroxyprogesterone 17-Acetate: Depot medroxyprogesterone acetate, SC, every 12 weeks for 1 year"
923631|NCT01019317|B1|Baseline|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
923632|NCT01019317|P1|Participant Flow|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
923633|NCT01019317|O1|Outcome|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
923634|NCT01019317|E1|Reported Event|Cytarabine + Fludarabine|Fludarabine 15 mg/m^2 intravenous (IV) every 12 hours for 5 days; Cytarabine 0.5 grams/m^2 IV over 2 hours every 12 hours for 5 days.
923635|NCT01019135|B4|Baseline|Total|Total of all reporting groups
923636|NCT01019135|B3|Baseline|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923637|NCT01019135|B2|Baseline|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923638|NCT01019135|B1|Baseline|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923639|NCT01019135|P3|Participant Flow|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923640|NCT01019135|P2|Participant Flow|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923641|NCT01019135|P1|Participant Flow|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923642|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923643|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923644|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923769|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923645|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923646|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923647|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923648|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923649|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923650|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923651|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923652|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923653|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923654|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923705|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
923657|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923658|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923659|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923660|NCT01019135|O3|Outcome|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923661|NCT01019135|O2|Outcome|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923662|NCT01019135|O1|Outcome|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923663|NCT01019135|E3|Reported Event|Home-Based Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923664|NCT01019135|E2|Reported Event|Co-ed Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923665|NCT01019135|E1|Reported Event|Women-Only Cardiac Rehabilitation|Cardiac Rehabilitation: comparison of multiple cardiac rehabilitation program models
923666|NCT01018992|B3|Baseline|Total|Total of all reporting groups
923667|NCT01018992|B2|Baseline|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
923668|NCT01018992|B1|Baseline|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
923669|NCT01018992|P2|Participant Flow|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
923670|NCT01018992|P1|Participant Flow|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
923671|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
923672|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
923673|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
923674|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
923675|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
923676|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
923677|NCT01018992|O2|Outcome|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
923678|NCT01018992|O1|Outcome|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
923679|NCT01018992|E2|Reported Event|Placebo|Adult women with DSM-IV defined PTSD received matching placebo for 6 weeks
923680|NCT01018992|E1|Reported Event|GSK561679|Adult women with DSM-IV-defined PTSD received GSK561679 at a fixed dose of 350 mg/day for 6-weeks
923681|NCT01018979|B3|Baseline|Total|Total of all reporting groups
923682|NCT01018979|B2|Baseline|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923683|NCT01018979|B1|Baseline|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923684|NCT01018979|P2|Participant Flow|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923685|NCT01018979|P1|Participant Flow|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923686|NCT01018979|O3|Outcome|All Patients|All patents = MM + NHL + HD
923687|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
923688|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
923689|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923690|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923691|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923692|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923693|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923694|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923695|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923696|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923697|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923698|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923699|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923700|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923701|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923702|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923703|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923704|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923706|NCT01018979|O2|Outcome|Non-Hodgkin Lymphoma (NHL) + Hodgkin Disease (HD)|10 patients and 2 patients with NHL and HD were enrolled, respectively.
923707|NCT01018979|O1|Outcome|Multiple Myeloma (MM)|7 patients with MM were enrolled.
923708|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923709|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923710|NCT01018979|O2|Outcome|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923711|NCT01018979|O1|Outcome|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923712|NCT01018979|E2|Reported Event|TG-0054 (3.14 mg/kg)|TG-0054: 3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923713|NCT01018979|E1|Reported Event|TG-0054 (2.24 mg/kg)|TG-0054: 2.24 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of six leukapheresis sessions)
923714|NCT01018953|B1|Baseline|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
923715|NCT01018953|P1|Participant Flow|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
923716|NCT01018953|O1|Outcome|BIM 23A760|
923717|NCT01018953|O1|Outcome|BIM 23A760|
923718|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
923719|NCT01018953|O1|Outcome|BIM 23A760|
923720|NCT01018953|O1|Outcome|BIM 23A760|
923721|NCT01018953|O1|Outcome|BIM 23A760|
923722|NCT01018953|O1|Outcome|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
923770|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
927903|NCT01010282|B4|Baseline|Total|Total of all reporting groups
923723|NCT01018953|E1|Reported Event|BIM 23A760|"This dose adaptive study was planned to treat up to 20 patients in each starting dose cohort, with a maximum of three starting dose cohorts. The doses planned to be assessed were 1, 2, 4, 6 and 8 mg; however, the maximum starting dose was 4 mg. The starting dose of the first cohort was 1 mg and the first cohort would include at least five patients. After the first 15 patients were treated for 4 weeks, the results were to be reviewed by a Data Review Committee. An extension phase (Part B) was planned for those subjects completing the initial study and fulfilling specific eligibility criteria (symptoms control, willingness to participate, safety and tolerability).~BIM 23A760 was a solution at a concentration of 5 mg/mL ready for subcutaneous injection. BIM 23A760 doses of 1, 2, 4, 6 and 8 mg were to be given to the patient according to a dose escalation and titration process. Patients would have received 24 weekly injections of BIM 23A760 during the treatment period."
923724|NCT01018862|B4|Baseline|Total|Total of all reporting groups
923725|NCT01018862|B3|Baseline|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923726|NCT01018862|B2|Baseline|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923727|NCT01018862|B1|Baseline|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923728|NCT01018862|P3|Participant Flow|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923729|NCT01018862|P2|Participant Flow|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923730|NCT01018862|P1|Participant Flow|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923731|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923732|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923733|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923734|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923735|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923736|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923737|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923738|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923739|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923740|NCT01018862|O3|Outcome|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923741|NCT01018862|O2|Outcome|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923742|NCT01018862|O1|Outcome|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923743|NCT01018862|E3|Reported Event|Placebo|0 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923744|NCT01018862|E2|Reported Event|MP03-33 (0.10% Solution)|548 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923745|NCT01018862|E1|Reported Event|MP03-36 (0.15% Solution)|822 mcg, Topical/intranasal spray, 1 spray per nostril twice daily/ 4 weeks
923746|NCT01018810|B6|Baseline|Total|Total of all reporting groups
923747|NCT01018810|B5|Baseline|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923748|NCT01018810|B4|Baseline|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923749|NCT01018810|B3|Baseline|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923750|NCT01018810|B2|Baseline|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923751|NCT01018810|B1|Baseline|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923752|NCT01018810|P5|Participant Flow|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923753|NCT01018810|P4|Participant Flow|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923754|NCT01018810|P3|Participant Flow|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923755|NCT01018810|P2|Participant Flow|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923756|NCT01018810|P1|Participant Flow|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923757|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923758|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923759|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923760|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923761|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923762|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923763|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923764|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923765|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923766|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923767|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923768|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923771|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923772|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923773|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923774|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923775|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923776|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923777|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923778|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923779|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923780|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923781|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923782|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923783|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923784|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923785|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923786|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923787|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923788|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923789|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923790|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923791|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923792|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923793|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923794|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923795|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923796|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923797|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923798|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923799|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923800|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923801|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923802|NCT01018810|O5|Outcome|90 mg LY2525623|90 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923803|NCT01018810|O4|Outcome|30 mg LY2525623|30 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923804|NCT01018810|O3|Outcome|3 mg LY2525623|3 mg LY2525623 administered subcutaneously at randomization and every 2 weeks for 6 weeks
923805|NCT01018810|O2|Outcome|Subcutaneous Placebo|Placebo administered subcutaneously at randomization and every 2 weeks for 6 weeks
923806|NCT01018810|O1|Outcome|180 mg LY2525623|180 mg LY2525623 administered intravenously at randomization and every 2 weeks for 6 weeks
923807|NCT01018810|E5|Reported Event|90 mg LY2525623|
923808|NCT01018810|E4|Reported Event|30 mg LY2525623|
923809|NCT01018810|E3|Reported Event|3 mg LY2525623|
923810|NCT01018810|E2|Reported Event|Subcutaneous Placebo|
923811|NCT01018810|E1|Reported Event|180 mg LY2525623|
923812|NCT01018732|B4|Baseline|Total|Total of all reporting groups
923813|NCT01018732|B3|Baseline|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
923814|NCT01018732|B2|Baseline|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
923815|NCT01018732|B1|Baseline|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
923816|NCT01018732|P3|Participant Flow|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
923817|NCT01018732|P2|Participant Flow|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
923818|NCT01018732|P1|Participant Flow|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
923819|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923853|NCT01018680|P1|Participant Flow|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923820|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923821|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923822|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923823|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923824|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923825|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923826|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923827|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923828|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923829|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923830|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923831|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923832|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923833|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923834|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923835|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923836|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923837|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923838|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923839|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923840|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923841|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923842|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923843|NCT01018732|O3|Outcome|III: Meningococcal-naive|Subjects were meningococcal vaccine naive and age inclusive (16-23 years)and were given one dose of Men ACWY-CRM vaccine during the study.
923844|NCT01018732|O2|Outcome|II:Licensed Polysacharide Meningococcal Vaccine|Subjects had been given one dose of licensed polysaccharide meningococcal Serogroup ACWY vaccine(Menomune),5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923845|NCT01018732|O1|Outcome|I:MenACWY|Subjects had been given one dose of Meningococcal (MenACWY) vaccine 5 years ago and were given one dose of Men ACWY-CRM vaccine during the study.
923846|NCT01018732|E3|Reported Event|III: Meningococcal Naive|Subjects were between 16 years to 23 years (age-inclusive)and meningococcal vaccine naive
923847|NCT01018732|E2|Reported Event|II: Licensed Polysaccharide Meningococcal Vaccine|Subjects had been given one dose of licensed Meningococcal (Men ACWY) polysaccharide vaccine (Menomune) 5 years ago
923848|NCT01018732|E1|Reported Event|I: MenACWY-CRM Vaccine|Subjects had been given one dose of Meningococcal ACWY (MenACWY)vaccine conjugated to CRM197 (cross-reactive material-mutant of diptheria toxin) 5 years ago
923849|NCT01018680|B3|Baseline|Total|Total of all reporting groups
923850|NCT01018680|B2|Baseline|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923851|NCT01018680|B1|Baseline|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923852|NCT01018680|P2|Participant Flow|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923854|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923855|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923856|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923857|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923858|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923859|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
924357|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924876|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
923860|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923861|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923862|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923863|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923864|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923865|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923866|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923867|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923868|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923869|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923870|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923871|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923872|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923873|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923874|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923875|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923876|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923877|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923878|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923879|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923880|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923881|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923908|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923882|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923883|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923884|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923885|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923886|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923887|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923888|NCT01018680|O2|Outcome|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923889|NCT01018680|O1|Outcome|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
951236|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
923890|NCT01018680|E2|Reported Event|Duloxetine|Participants initially received 30 milligrams (mg) duloxetine by mouth, once daily for 1 week, followed by 60 mg by mouth, once daily thereafter. At end of 3 weeks, participants with a weekly mean 24-hour average pain value ≥4 in week preceding their visit had their dose escalated up to 120 mg by mouth, once daily until Week 10.
923891|NCT01018680|E1|Reported Event|Placebo|Participants received placebo by mouth, once daily for 10 weeks.
923892|NCT01018511|B5|Baseline|Total|Total of all reporting groups
923893|NCT01018511|B4|Baseline|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923894|NCT01018511|B3|Baseline|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923895|NCT01018511|B2|Baseline|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923896|NCT01018511|B1|Baseline|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923897|NCT01018511|P4|Participant Flow|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923898|NCT01018511|P3|Participant Flow|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923899|NCT01018511|P2|Participant Flow|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923900|NCT01018511|P1|Participant Flow|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923901|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923902|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923903|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923904|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923905|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923906|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923907|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924079|NCT01018420|O1|Outcome|Baseline|measured 0.5 hour prior to moxifloxacin dose
924080|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after initial colchicine dose
923909|NCT01018511|O2|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923910|NCT01018511|O1|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923911|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923912|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923913|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923914|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924256|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
923915|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923916|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923917|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923918|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923919|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923920|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923921|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923922|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923923|NCT01018511|O3|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923924|NCT01018511|O2|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923925|NCT01018511|O1|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923926|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923927|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923928|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923929|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923930|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923931|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923932|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923933|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923934|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923935|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923936|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923937|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923938|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924877|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
923939|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923940|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923941|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923942|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923943|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923944|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923945|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923946|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923947|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923948|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923949|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923950|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923951|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923952|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923953|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923954|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923955|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924081|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after initial colchicine dose
923956|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923957|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923958|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923959|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923960|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923961|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924257|NCT01018134|E6|Reported Event|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
923962|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923963|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923964|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923965|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923966|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923967|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923968|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923969|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923970|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923971|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923972|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923973|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923974|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923975|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923976|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923977|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923978|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923979|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923980|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923981|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923982|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923983|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923984|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924008|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923985|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923986|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923987|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923988|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923989|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923990|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923991|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923992|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923993|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923994|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923995|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923996|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923997|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923998|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
923999|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924000|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924082|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after initial colchicine dose
924083|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after initial colchicine dose
928304|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
924001|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924002|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924003|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924004|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924005|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924006|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924007|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924253|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924009|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924010|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924011|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924012|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924013|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924014|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924015|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924016|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924017|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924018|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924019|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924020|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924021|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924022|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924023|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924024|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924025|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924026|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924027|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924028|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924029|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924030|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924031|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924254|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924032|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924033|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924034|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924035|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924036|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924037|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924038|NCT01018511|O4|Outcome|FDC 0.4 mg 9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924039|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924040|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924041|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924042|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924043|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924044|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924045|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924046|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924047|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924048|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924049|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924050|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924051|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924052|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924053|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924054|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924258|NCT01018134|E5|Reported Event|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924055|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924056|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924057|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924058|NCT01018511|O4|Outcome|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924059|NCT01018511|O3|Outcome|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924060|NCT01018511|O2|Outcome|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924061|NCT01018511|O1|Outcome|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924062|NCT01018511|E4|Reported Event|FDC 0.4 mg/9 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924063|NCT01018511|E3|Reported Event|FDC 0.4 mg/6 mg|Participants received 3 tablets once a day for 12 weeks. Placebo TOCAS 0.4 mg tablet; FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924064|NCT01018511|E2|Reported Event|TOCAS 0.4 mg|Participants received 3 tablets once a day for 12 weeks. Tamsulosin hydrochloride OCAS (TOCAS) 0.4 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924065|NCT01018511|E1|Reported Event|Placebo|Participants received 3 tablets once a day for 12 weeks. Placebo tamsulosin hydrochloride oral controlled absorption system (OCAS) 0.4 mg tablet; Placebo fixed dose combination (FDC) tamsulosin hydrochloride/solifenacin succinate 0.4 mg/6 mg tablet; Placebo FDC tamsulosin hydrochloride/solifenacin succinate 0.4 mg/9 mg tablet
924066|NCT01018420|B3|Baseline|Total|Total of all reporting groups
924067|NCT01018420|B2|Baseline|Moxifloxacin|400 mg capsule at the 6 hour point
924068|NCT01018420|B1|Baseline|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
924069|NCT01018420|P2|Participant Flow|Moxifloxacin|400 mg capsule at the 6 hour point
924070|NCT01018420|P1|Participant Flow|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
924071|NCT01018420|O9|Outcome|Hour 23|measured 23 hours after moxifloxacin dose
924072|NCT01018420|O8|Outcome|Hour 12|measured 12 hours after moxifloxacin dose
924073|NCT01018420|O7|Outcome|Hour 10|measured 10 hours after moxifloxacin dose
924074|NCT01018420|O6|Outcome|Hour 8|measured 8 hours after moxifloxacin dose
924075|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after moxifloxacin dose
924076|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after moxifloxacin dose
924077|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after moxifloxacin dose
924078|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after moxifloxacin dose
924084|NCT01018420|O5|Outcome|Hour 7|measured 7 hours after initial colchicine dose
924085|NCT01018420|O4|Outcome|Hour 6|measured 6 hours after initial colchicine dose
924086|NCT01018420|O3|Outcome|Hour 3|measured 3 hours after initial colchicine dose
924087|NCT01018420|O2|Outcome|Hour 1|measured 1 hour after initial colchicine dose
924088|NCT01018420|O1|Outcome|Baseline|measured 0.5 hr prior to initial colchicine dose
924089|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
924090|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
924091|NCT01018420|O1|Outcome|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
924092|NCT01018420|E2|Reported Event|Moxifloxacin|400 mg capsule at the 6 hour point
924093|NCT01018420|E1|Reported Event|Colchicine|1.2mg initially (two 0.6 mg capsules) followed by an additional 0.6mg capsule every hour for 6 additional doses [4.8mg over 6 hours]
924094|NCT01018394|B3|Baseline|Total|Total of all reporting groups
924095|NCT01018394|B2|Baseline|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
924255|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924096|NCT01018394|B1|Baseline|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
924097|NCT01018394|P2|Participant Flow|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
924098|NCT01018394|P1|Participant Flow|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
924099|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
924100|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
924101|NCT01018394|O2|Outcome|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
924102|NCT01018394|O1|Outcome|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
924103|NCT01018394|E2|Reported Event|Tobacco Free Snuff|"Subjects will receive tobacco free snuff for 8 -12 weeks. The tobacco-free snuff will be used ad lib - as needed.~tobacco-free snuff : Tobacco-free snuff used ad lib for a maximum of 12 weeks"
924104|NCT01018394|E1|Reported Event|Nicotine Lozenges|"Subjects will be assigned to receive nicotine lozenges for 8 weeks. They will use the nicotine lozenges ad lib, up to 8 lozenges per day.~nicotine lozenges : 4 mg nicotine lozenges for a maximum duration of 12 weeks used ad lib - up to 8 nicotine lozenges per day."
924105|NCT01018264|B3|Baseline|Total|Total of all reporting groups
924106|NCT01018264|B2|Baseline|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924107|NCT01018264|B1|Baseline|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924108|NCT01018264|P2|Participant Flow|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924109|NCT01018264|P1|Participant Flow|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924110|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924111|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924112|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924113|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924114|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924115|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924116|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924117|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924118|NCT01018264|O2|Outcome|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924119|NCT01018264|O1|Outcome|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924120|NCT01018264|E2|Reported Event|Placebo|placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
924121|NCT01018264|E1|Reported Event|Solifenacin Succinate (VESIcare)|solifenacin succinate (VESIcare): up to 10mg every day orally
924122|NCT01018186|B4|Baseline|Total|Total of all reporting groups
924123|NCT01018186|B3|Baseline|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924124|NCT01018186|B2|Baseline|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924125|NCT01018186|B1|Baseline|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924126|NCT01018186|P4|Participant Flow|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924127|NCT01018186|P3|Participant Flow|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924128|NCT01018186|P2|Participant Flow|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924342|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
926274|NCT01014143|B3|Baseline|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
924129|NCT01018186|P1|Participant Flow|Current Asthma Therapy at a Fixed Dose|Participants were instructed to continue using an approved fixed dose of an inhaled corticosteroid (ICS) with or without an additional controller medication (i.e., long-acting beta-agonist, leukotriene modifier, etc.) for 2 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Run-in Period.
924130|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924131|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924132|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924133|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924134|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924135|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924136|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924137|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924138|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924139|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924140|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924141|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924142|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924143|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924144|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924320|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924321|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924145|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924146|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924147|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924148|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924149|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924150|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924151|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
951237|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
924152|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924153|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924154|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924155|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924156|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924157|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924158|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924159|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924160|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924161|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924162|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924163|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924164|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924165|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924166|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924167|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924955|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
924168|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924169|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924170|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924171|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924172|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924173|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924174|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924343|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924175|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924176|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924177|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924178|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924179|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924180|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924181|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albutero/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924182|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participnts were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924183|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924184|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924185|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924186|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924187|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924188|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924189|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924190|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924191|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924192|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924193|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924194|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924195|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924196|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924197|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924344|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
951238|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
924198|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924199|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924200|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924201|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924202|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924203|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924204|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924205|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received FP 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924206|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924207|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received FF/VI 100/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924208|NCT01018186|O3|Outcome|FP 500 µg BID|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924209|NCT01018186|O2|Outcome|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924210|NCT01018186|O1|Outcome|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924211|NCT01018186|E3|Reported Event|FP 500 µg BD|Participants received Fluticasone Propionate (FP) 500 µg BID via DISKUS/ACCUHALER, plus a placebo via the DPI OD in the evening, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924212|NCT01018186|E2|Reported Event|FF/VI 200/25 µg OD|Participants received FF/VI 200/25 µg inhalation powder OD in the evening via the DPI, plus a placebo via DISKUS/ACCUHALER BID, for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924398|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924213|NCT01018186|E1|Reported Event|FF/VI 100/25 µg OD|Participants received Fluticasone Furoate (FF)/Vilanterol (VI) 100/25 micrograms (µg) inhalation powder once daily (OD) in the evening via the Dry Powder Inhaler (DPI), plus a placebo via DISKUS/ACCUHALER twice daily (BID), for 52 weeks. Participants were provided albuterol/salbutamol inhalation aerosol to be used as rescue medication during the Treatment Period.
924214|NCT01018134|B7|Baseline|Total|Total of all reporting groups
924215|NCT01018134|B6|Baseline|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
924216|NCT01018134|B5|Baseline|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924217|NCT01018134|B4|Baseline|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924218|NCT01018134|B3|Baseline|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924219|NCT01018134|B2|Baseline|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924220|NCT01018134|B1|Baseline|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
924221|NCT01018134|P6|Participant Flow|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
924222|NCT01018134|P5|Participant Flow|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924345|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924223|NCT01018134|P4|Participant Flow|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924224|NCT01018134|P3|Participant Flow|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924225|NCT01018134|P2|Participant Flow|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924226|NCT01018134|P1|Participant Flow|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
924227|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
924228|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924229|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924230|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924231|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924232|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
924233|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
924234|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924235|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924236|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924237|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924238|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
924239|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
924240|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924241|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924529|NCT01017536|E1|Reported Event|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
924242|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924243|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924244|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
924245|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
924246|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924247|NCT01018134|O4|Outcome|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924248|NCT01018134|O3|Outcome|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924249|NCT01018134|O2|Outcome|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924250|NCT01018134|O1|Outcome|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
924251|NCT01018134|O6|Outcome|Vehicle Twice Daily|"Vehicle administered to affected areas twice daily~Vehicle twice daily: Vehicle topical spray administered to affected areas twice daily for 28 days"
924252|NCT01018134|O5|Outcome|Vehicle Once Daily|"Vehicle administered to affected areas once daily~Vehicle once daily: Vehicle topical spray administered to affected areas once daily for 28 days"
924259|NCT01018134|E4|Reported Event|Desoximetasone 0.25% Twice Daily|"Desoximetasone topical spray 0.25% administered twice daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected areas twice daily for 28 days"
924260|NCT01018134|E3|Reported Event|Desoximetasone 0.25% Once Daily|"Desoximetasone topical spray 0.25% administered once daily to affected area~Desoximetasone 0.25% once daily: Desoximetasone topical spray 0.25% administered to affected area once daily for 28 days"
924261|NCT01018134|E2|Reported Event|Desoximetasone 0.05% Twice Daily|"Desoximetasone topical spray 0.05% administered twice daily to affected area~Desoximetasone 0.05% twice daily: Desoximetasone topical spray 0.05% administered to affected area twice daily for 28 days"
924262|NCT01018134|E1|Reported Event|Desoximetasone 0.05% Once Daily|"Desoximetasone topical spray 0.05% administered once daily to affected area~Desoximetasone 0.05% once daily: Desoximetasone topical spray 0.05% administered to affected area once daily for 28 days"
924263|NCT01018095|B3|Baseline|Total|Total of all reporting groups
924264|NCT01018095|B2|Baseline|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924265|NCT01018095|B1|Baseline|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924266|NCT01018095|P2|Participant Flow|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924267|NCT01018095|P1|Participant Flow|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924268|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924269|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924270|NCT01018095|O2|Outcome|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924271|NCT01018095|O1|Outcome|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924272|NCT01018095|E2|Reported Event|Single Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924273|NCT01018095|E1|Reported Event|7 Day Dose|Metronidazole : 2 gm single dose versus 7 day 500 mg BID dose
924274|NCT01018056|B4|Baseline|Total|Total of all reporting groups
924275|NCT01018056|B3|Baseline|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924276|NCT01018056|B2|Baseline|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924293|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924530|NCT01017497|B1|Baseline|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924277|NCT01018056|B1|Baseline|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924278|NCT01018056|P3|Participant Flow|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924279|NCT01018056|P2|Participant Flow|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924280|NCT01018056|P1|Participant Flow|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924346|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924281|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for MASC is 4."
924282|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924283|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924284|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that two subjects failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for CDI-S is 3."
924315|NCT01018030|P3|Participant Flow|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924316|NCT01018030|P2|Participant Flow|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924317|NCT01018030|P1|Participant Flow|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
924318|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924319|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924285|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924286|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924287|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules.~Please note that one subject failed to complete this assessment on week 6; therefore, the total number of participants in the placebo group for DuPaul ADHD is 4."
924288|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924347|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924348|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924349|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924350|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924351|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
927308|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
924289|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924290|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924291|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924292|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924294|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924295|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924296|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924297|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924352|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924353|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924298|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924299|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924300|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924301|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924302|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924303|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924304|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924305|NCT01018056|O3|Outcome|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924306|NCT01018056|O2|Outcome|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924354|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924355|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924307|NCT01018056|O1|Outcome|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924308|NCT01018056|E3|Reported Event|Placebo|"12 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive placebo for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Placebo: Placebo tablets will be formulated in look-alike capsules. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing additional placebo capsules."
924309|NCT01018056|E2|Reported Event|Riluzole (Glutamate Antagonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive riluzole for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~Riluzole: The starting dose of riluzole will be 50 mg for one week; administered as one capsule (50) every morning. Dosage schedules will be flexible. If needed for tic suppression, the dose will be increased weekly by 50 mg and given in BID doses. The maximum dose will be 200 mg/day (administered as 2 capsules BID). In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of 14 capsules labeled as study drug, but containing placebo capsules. No changes in dosage will be made during the final week of treatment."
924310|NCT01018056|E1|Reported Event|D-serine (Glutamate Agonist)|"24 subjects age 8-17 years with moderate to severe TS (TTS > 22) will be enrolled in this treatment arm. They will receive D-serine for 6-weeks of the study, during which time drug dose may gradually be increased as needed. At 6-weeks participants will taper off drug.~D-serine: The dosage schedule will be flexible with a maximum dose for each subject being 30 mg/kg/day. In any individual subject, dose escalation may proceed more slowly, or the dose may be reduced if necessary. At the 4 week visit, if an additional dosage increase is prescribed by Dr Singer, the pharmacy will provide an additional vial of capsules labeled as study drug, but containing either 250 or 500 mg tablets of D-serine or placebo; capsule content to be determined by patient’s weight. No changes in dosage will be made during the final week of treatment."
924311|NCT01018030|B4|Baseline|Total|Total of all reporting groups
924312|NCT01018030|B3|Baseline|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924313|NCT01018030|B2|Baseline|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924314|NCT01018030|B1|Baseline|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
924322|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924323|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924324|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924325|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924326|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924327|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924328|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924329|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924330|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924331|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924332|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924333|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924334|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924335|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924336|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924337|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924338|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924339|NCT01018030|O3|Outcome|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924340|NCT01018030|O2|Outcome|FFNS 110 mcg QD|FFNS 110 mcg administered QD in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924341|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered BD for 14 days
924358|NCT01018030|O2|Outcome|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924359|NCT01018030|O1|Outcome|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
924360|NCT01018030|E3|Reported Event|FFNS 110 mcg BD|FFNS 110 mcg administered BD for 14 days
924361|NCT01018030|E2|Reported Event|FFNS 110 mcg QD|Fluticasone Furoate Nasal Spray (FFNS) 110 micrograms (mcg) administered once daily (QD) in the morning and vehicle placebo nasal spray administered in the evening for 14 days
924362|NCT01018030|E1|Reported Event|Placebo|Vehicle Placebo Nasal Spray administered twice daily (BD) for 14 days
924363|NCT01017952|B5|Baseline|Total|Total of all reporting groups
924364|NCT01017952|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924365|NCT01017952|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924366|NCT01017952|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924367|NCT01017952|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924368|NCT01017952|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924369|NCT01017952|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924370|NCT01017952|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the NDPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924371|NCT01017952|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924372|NCT01017952|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
924373|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924374|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928305|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
924375|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924376|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924377|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924378|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924379|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924380|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924381|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924382|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924383|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924384|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924385|NCT01017952|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924386|NCT01017952|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924387|NCT01017952|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924388|NCT01017952|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924389|NCT01017952|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924390|NCT01017952|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924391|NCT01017952|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924392|NCT01017952|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
924393|NCT01017874|B3|Baseline|Total|Total of all reporting groups
924394|NCT01017874|B2|Baseline|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924395|NCT01017874|B1|Baseline|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924396|NCT01017874|P2|Participant Flow|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924397|NCT01017874|P1|Participant Flow|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924399|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924400|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924401|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924402|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924403|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924404|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924405|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924406|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924407|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924408|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924409|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924410|NCT01017874|O2|Outcome|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924411|NCT01017874|O1|Outcome|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924412|NCT01017874|E2|Reported Event|Gefitinib|Gefitinib: 250 mg administered orally once a day, every day of 21-day cycle, as a monotherapy
924413|NCT01017874|E1|Reported Event|Pemetrexed + Cisplatin + Gefitinib|"Pemetrexed: 500 milligrams per square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Gefitinib: 250 milligrams (mg) administered orally once a day, every day of 21-day cycle, as maintenance therapy in participants with non-progressive disease after cisplatin/pemetrexed chemotherapy"
924414|NCT01017731|B1|Baseline|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924415|NCT01017731|P1|Participant Flow|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924416|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924417|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously over 1 hour, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: 25 to 50 milligrams (mg) administered intravenously 1 day before each administration of ramucirumab for Cycles 1 to 4. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924418|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924438|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924759|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
927309|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
924419|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924420|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924421|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924422|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924423|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924432|NCT01017653|P1|Participant Flow|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924956|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
924424|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924425|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924426|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924439|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924427|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924428|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924429|NCT01017731|O1|Outcome|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924430|NCT01017731|E1|Reported Event|IMC-1121B (Ramucirumab)|"Ramucirumab: 10 milligrams/kilogram (mg/kg) infused intravenously, every 3 weeks (Day 1 of every 21-day cycle). Treatment continued for a minimum of 9 weeks without a break in between until there was evidence of disease progression or intolerable toxicity.~Diphenhydramine: For Cycle 1 only, 25 to 50 milligrams (mg) diphenhydramine infused intravenously 1 day before ramucirumab therapy. For Cycles 1, 2, 3, and 4, 25 to 50 mg diphenhydramine infused intravenously 15 minutes before ramucirumab therapy. For Cycle 5 and beyond, premedication with diphenhydramine was at the discretion of the investigator. Each participant was administered the same dose of diphenhydramine at all time points.~Moxifloxacin: The first 16 participants enrolled received a single dose of moxifloxacin (400 mg tablet orally by mouth) 1 week prior to being treated with ramucirumab."
924431|NCT01017653|B1|Baseline|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924528|NCT01017536|E2|Reported Event|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
924433|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924434|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924435|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924436|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924437|NCT01017653|O1|Outcome|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924760|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
927310|NCT01011868|O1|Outcome|Placebo|Oral Placebo
924440|NCT01017653|E1|Reported Event|Panitumumab and Irinotecan|Panitumumab in Combination with Irinotecan : Panitumumab, 6mg/kg, as an intravenous infusion every other week in combination with Irinotecan (dose dependent upon whether the patient is taking an enzyme-inducing anti-epileptic drug [EIAED]). On an enzyme-inducing anti-epileptic drug (EIAED), irinotecan will be dosed at 340 mg/m2 every other week. Not on an EIAED, irinotecan will be dosed at 125 mg/m2. Treatment will continue until tumor progression or unacceptable toxicity.
924441|NCT01017601|B3|Baseline|Total|Total of all reporting groups
924442|NCT01017601|B2|Baseline|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924443|NCT01017601|B1|Baseline|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924444|NCT01017601|P2|Participant Flow|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924445|NCT01017601|P1|Participant Flow|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924446|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924447|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924448|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924449|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924450|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924451|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924452|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924453|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924454|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924455|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924456|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924457|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924458|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924459|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924460|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924461|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924462|NCT01017601|O2|Outcome|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924463|NCT01017601|O1|Outcome|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924464|NCT01017601|E2|Reported Event|Arm II (Placebo)|Patients receive a single dose of placebo IV over 1 hour on day 1.
924465|NCT01017601|E1|Reported Event|Arm I (NTX-010)|Patients receive a single dose of Seneca Valley virus-001 (NTX-010) IV over 1 hour on day 1.
924466|NCT01017575|B6|Baseline|Total|Total of all reporting groups
924467|NCT01017575|B5|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
928306|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
924468|NCT01017575|B4|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924469|NCT01017575|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924470|NCT01017575|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924471|NCT01017575|B1|Baseline|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924472|NCT01017575|P5|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924473|NCT01017575|P4|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924474|NCT01017575|P3|Participant Flow|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924878|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924475|NCT01017575|P2|Participant Flow|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924476|NCT01017575|P1|Participant Flow|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924477|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924478|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924479|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924480|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924481|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924482|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924483|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924484|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924485|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924486|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924487|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924488|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924489|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924490|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924491|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924492|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924879|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924493|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924494|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924495|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924496|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924497|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924498|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924499|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924500|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924501|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924502|NCT01017575|O5|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924503|NCT01017575|O4|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non­responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924504|NCT01017575|O3|Outcome|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924505|NCT01017575|O2|Outcome|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN­ containing regimens including pegIFNα-2a/ ribavirin.
924506|NCT01017575|O1|Outcome|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha­2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) ­containing regimens including pegIFNα-2a/ ribavirin.
924507|NCT01017575|E5|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924508|NCT01017575|E4|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
924509|NCT01017575|E3|Reported Event|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
924510|NCT01017575|E2|Reported Event|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
924761|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924511|NCT01017575|E1|Reported Event|Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
924512|NCT01017549|B1|Baseline|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
924513|NCT01017549|P1|Participant Flow|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
924514|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
924515|NCT01017549|O1|Outcome|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
924516|NCT01017549|E1|Reported Event|Electronic Brachytherapy|Radiation therapy was delivered using the 510(k) cleared Xoft Axxent System. Accelerated partial breast irradiation is the method of radiation therapy administration that has been commonly used by physicians using Iridium-192, but was FDA cleared for use prior to commencing study enrollment using an electronic source.
924517|NCT01017536|B3|Baseline|Total|Total of all reporting groups
924518|NCT01017536|B2|Baseline|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
924519|NCT01017536|B1|Baseline|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
924520|NCT01017536|P2|Participant Flow|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
924521|NCT01017536|P1|Participant Flow|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
924522|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
924523|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
924524|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
924525|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
924526|NCT01017536|O2|Outcome|Investigational Vaccine|AERAS-402: AERAS-402 is a replication-deficient serotype 35 adenovirus containing DNA that expresses a fusion protein of three Mycobacterium tuberculosis (Mtb) antigens: 85A, 85B and TB10.4.
924527|NCT01017536|O1|Outcome|Placebo|Placebo Control: Placebo was the identical buffer solution in which AERAS-402 is formulated.
924531|NCT01017497|P1|Participant Flow|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924532|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924533|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924534|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924535|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924536|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924537|NCT01017497|O1|Outcome|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924538|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
924539|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
924540|NCT01017497|O2|Outcome|3mm Margin|"GTV expanded by 3 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
924541|NCT01017497|O1|Outcome|1mm Margin|"GTV expanded by 1 mm~Stereotactic Radiosurgery: PTV Diameter < 2.0 cm receives 24 Gy; PTV Diameter 2.0-3.0 cm receives 18 Gy; PTV Diameter 3.1-4.0 cm receives 15 Gy;"
924542|NCT01017497|E1|Reported Event|Optimal PTV|Optimal Planning Target Volume with Stereotactic Radiosurgery
924543|NCT01017263|B1|Baseline|Open Label Vyvanse|All subjects receive Vyvanse.
924544|NCT01017263|P1|Participant Flow|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (Vyvanse). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
924880|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924545|NCT01017263|O1|Outcome|Vyvanse Open Label|Eligible subjects were dispensed open label LDX (VyvanseTM). All subjects started at 20 mg once a day dose and were titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level was allowed.
924546|NCT01017263|E1|Reported Event|Open Label Vyvanse|Eligible subjects will be dispensed open label LDX (VyvanseTM). All subjects will start at 20 mg once a day dose and will be titrated up weekly by 10 mg increments up to a maximum dose of 70 mg. If a subject experiences intolerable side effects at a particular dose, a step down to the next tolerated level is allowed.
924547|NCT01017250|B1|Baseline|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924548|NCT01017250|P1|Participant Flow|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924549|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924550|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924551|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924552|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924553|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924554|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924555|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924556|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).
924557|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924558|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924559|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924560|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924561|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924562|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924563|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924564|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924565|NCT01017250|O1|Outcome|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924566|NCT01017250|E1|Reported Event|Stereotactic Radiosurgery|"Avastin 10 mg/kg given intravenously (IV) within 24 hours before and two weeks following their first treatment with Stereotactic Radiosurgery (SRS).~SRS is"
924567|NCT01017237|B3|Baseline|Total|Total of all reporting groups
924568|NCT01017237|B2|Baseline|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924569|NCT01017237|B1|Baseline|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924570|NCT01017237|P2|Participant Flow|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924632|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924571|NCT01017237|P1|Participant Flow|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924572|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924573|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924574|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924575|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924576|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924577|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924578|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924579|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924580|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
928307|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
924581|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924582|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924583|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924584|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924585|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924586|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924587|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924588|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924589|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924590|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924591|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924592|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924593|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924594|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924595|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924596|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924625|NCT01017146|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924597|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924598|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924599|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924600|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924601|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924753|NCT01016977|B2|Baseline|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924602|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924603|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924604|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924605|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924606|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924607|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924608|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924609|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924610|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924611|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924612|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924613|NCT01017237|O1|Outcome|Dex Plus Midazolam|Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg.
924614|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924615|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924754|NCT01016977|B1|Baseline|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
951239|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
924616|NCT01017237|O2|Outcome|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924617|NCT01017237|O1|Outcome|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924618|NCT01017237|O2|Outcome|Dexmedetomidine Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924619|NCT01017237|O1|Outcome|Dexmedetomidine Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924620|NCT01017237|E2|Reported Event|Dex Plus Midazolam and Ketamine|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg and 0.25 mg/kg ketamine i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose.~Ketamine : Ketamine 0.25 mg/ml administered i.v. following the dexmedetomidine loading dose and the midazolam."
924621|NCT01017237|E1|Reported Event|Dex Plus Midazolam|"Dexmedetomidine loading dose of 0.4 mcg/kg followed by an infusion of 0.5 mcg/kg/hr plus midazolam 0.04 mg/kg i.v.~Dexmedetomidine : Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for four minutes; resulting in a loading dose of 0.4 mcg/kg, Followed by an infusion of 0.5 mcg/kg/hr will be initiated and continued until the completion of surgery.~Midazolam : Midazolam 0.04 mg/kg i.v. administered after dexmedetomidine loading dose."
924622|NCT01017146|B3|Baseline|Total|Total of all reporting groups
924623|NCT01017146|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924624|NCT01017146|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924661|NCT01017120|B3|Baseline|Total|Total of all reporting groups
924957|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
924626|NCT01017146|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924627|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924628|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924629|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924630|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924631|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924762|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924633|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924634|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924635|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924636|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924637|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924638|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924639|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924640|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924641|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924642|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924643|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924644|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924645|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924646|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924647|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924648|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924649|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924755|NCT01016977|P2|Participant Flow|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924650|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924651|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924652|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924653|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924654|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924655|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924656|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924657|NCT01017146|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924658|NCT01017146|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924659|NCT01017146|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924660|NCT01017146|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924662|NCT01017120|B2|Baseline|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924663|NCT01017120|B1|Baseline|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924664|NCT01017120|P2|Participant Flow|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924665|NCT01017120|P1|Participant Flow|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924666|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924667|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
951240|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
924668|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924669|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924670|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924671|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924672|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924673|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924674|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924675|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924676|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924677|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924678|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924958|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
924679|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924680|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924681|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924682|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924683|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924684|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924756|NCT01016977|P1|Participant Flow|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
924685|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924686|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924687|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924688|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924689|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924690|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924691|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924692|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924693|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924694|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924695|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924696|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924697|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924698|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924699|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924700|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924701|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924757|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924702|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924703|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924704|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924705|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924706|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924707|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924708|NCT01017120|O2|Outcome|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924709|NCT01017120|O1|Outcome|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924710|NCT01017120|E2|Reported Event|Vehicle Foam|The matching vehicle foam containing only tazarotene foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Vehicle foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924711|NCT01017120|E1|Reported Event|Tazarotene Foam|Tazarotene foam containing 0.1% tazarotene in an emulsion formulation foam vehicle was applied to the face once daily in the early evening for 12 weeks. A sufficient amount of study product was applied to cover the entire face and was gently rubbed into the skin until the study product disappeared. Tazarotene foam was packaged in a 100-gram aluminum can pressurized with a hydrocarbon propellant.
924712|NCT01017042|B1|Baseline|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
924713|NCT01017042|P1|Participant Flow|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
924714|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
924715|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
924716|NCT01017042|O5|Outcome|Corrected QTc Interval (4 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (4 hour)
924717|NCT01017042|O4|Outcome|Corrected QTc Interval (2 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (2 hour)
924718|NCT01017042|O3|Outcome|Corrected QTc Interval (1 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (1 hour)
924719|NCT01017042|O2|Outcome|Corrected QTc Interval (0.5 Hour)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (0.5hour)
924720|NCT01017042|O1|Outcome|Corrected QTc Interval (Baseline)|colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) QTc corrected by Fridericia’s formula (Baseline)
924721|NCT01017042|O1|Outcome|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
924873|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924722|NCT01017042|E1|Reported Event|Oral Colchicine 1.2mg + 0.6mg|On the morning of day one after a fast of at least 10 hours, all study participants received colchicine 1.2mg by mouth initially then an additional 0.6mg orally 1 hour later (1.8mg over 2 hours) Blood was drawn at times sufficient to characterize the pharmacokinetics of Colchicine under this therapeutic regimen.
924723|NCT01017029|B3|Baseline|Total|Total of all reporting groups
924724|NCT01017029|B2|Baseline|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924725|NCT01017029|B1|Baseline|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924726|NCT01017029|P2|Participant Flow|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924727|NCT01017029|P1|Participant Flow|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924728|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924729|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924730|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924731|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924732|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924733|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924734|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924735|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924736|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924737|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924738|NCT01017029|O2|Outcome|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924739|NCT01017029|O1|Outcome|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924740|NCT01017029|E2|Reported Event|Delayed Introduction of Everolimus|Mycophenolate mofetil (MMF) within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids. After 4 to 6 weeks since transplant, everolimus in place of MMF and dose of cyclosporine reduced.
924959|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
924741|NCT01017029|E1|Reported Event|Immediate Introduction of Everolimus|Everolimus within 144 hours (5 days) after graft reperfusion + cyclosporine microemulsion + steroids
924742|NCT01017003|B1|Baseline|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
924743|NCT01017003|P1|Participant Flow|Colchicine - Single Dose, Twice Daily Dose, Final Single Dose|All subjects received a single dose of colchicine 0.6 mg on Day 1 following an overnight fast. After a 14-day washout period, subjects received colchicine 0.6 mg every 12 hours for 10 days. On the morning of Day 25, subjects received their final colchicine 0.6 mg dose following an overnight fast.
924744|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
924745|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
924746|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
924747|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
924748|NCT01017003|O2|Outcome|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
924749|NCT01017003|O1|Outcome|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
924750|NCT01017003|E2|Reported Event|Colchicine Pharmacokinetics at Steady State (Day 25)|0.6mg colchicine tablet administered to healthy fasted volunteers after a regimen of oral colchicine 0.6mg every 12 hours for 10 days (Day 25)
924751|NCT01017003|E1|Reported Event|Colchicine Pharmacokinetics (Day 1)|0.6mg colchicine orally administered to healthy fasted volunteers as a single isolated dose (Day 1)
924752|NCT01016977|B3|Baseline|Total|Total of all reporting groups
924758|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924763|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924764|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924765|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924766|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924767|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924768|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924769|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924770|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924771|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924772|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924773|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924774|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924775|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924776|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924777|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924778|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924779|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924780|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924781|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream at PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924782|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924783|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924960|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
924784|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in PM and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in AM daily for topical administration on face
924785|NCT01016977|O2|Outcome|Tazorac Cream/Acanya Gel|Tazorac (tazarotene 0.1%) cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924786|NCT01016977|O1|Outcome|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
924787|NCT01016977|E2|Reported Event|Tazorac Cream/Acanya Gel|Tazorac cream in PM and Acanya (clindamycin phosphate 1.2%/benzoyl peroxide 2.5%) gel in AM daily for topical administration on face
924788|NCT01016977|E1|Reported Event|Tazorac Cream/Duac Gel|Tazorac (tazarotene 0.1%) cream in evening (PM) and Duac (clindamycin 1%/benzoyl peroxide 5%) gel in morning (AM) daily for topical administration on face
924789|NCT01016964|B3|Baseline|Total|Total of all reporting groups
924790|NCT01016964|B2|Baseline|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
924791|NCT01016964|B1|Baseline|Sham Device|Sham device
924792|NCT01016964|P2|Participant Flow|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
924793|NCT01016964|P1|Participant Flow|Sham Device|Sham device
924794|NCT01016964|O2|Outcome|LLT Device 2009 12 Beams|This is the active LLLT device
924795|NCT01016964|O1|Outcome|Sham Device|This control device emits white light
924796|NCT01016964|E2|Reported Event|LLT Device 2009 12 Beams|HairMax LaserComb 2009 model 12 beam
924797|NCT01016964|E1|Reported Event|Sham Device|Sham device
924798|NCT01016938|B1|Baseline|Dynmaic Lung MRI|Lung Tumor Motion and Function
924799|NCT01016938|P1|Participant Flow|Dynamic Lung MRI|Lung Tumor Motion and Function
924800|NCT01016938|O1|Outcome|Dynamic Lung MRI|Lung Tumor Motion and Function
924801|NCT01016938|O1|Outcome|Lung Tumor Motion and Lung Function|This is a pilot study and there is only one group.
924802|NCT01016938|E1|Reported Event|Dynamic Lung MRI|Lung Tumor Motion and Function
924803|NCT01016912|B6|Baseline|Total|Total of all reporting groups
924804|NCT01016912|B5|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
927311|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
924805|NCT01016912|B4|Baseline|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924806|NCT01016912|B3|Baseline|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924807|NCT01016912|B2|Baseline|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924808|NCT01016912|B1|Baseline|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924809|NCT01016912|P5|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
924810|NCT01016912|P4|Participant Flow|Daclatasvir 10­ mg + pegIFNα+ Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924811|NCT01016912|P3|Participant Flow|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924812|NCT01016912|P2|Participant Flow|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and peginterferon alpha-2b (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924813|NCT01016912|P1|Participant Flow|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924814|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
924815|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924816|NCT01016912|O3|Outcome|Daclatasvir 60 mg + Peg-IFNα + Ribavirin (Treatment-naive)|received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924817|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
924818|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
924819|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin
924820|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924821|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924822|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924874|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924875|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
951241|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
924823|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924824|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
924825|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonreponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924826|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924827|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924828|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924829|NCT01016912|O5|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
924830|NCT01016912|O4|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin..
924831|NCT01016912|O3|Outcome|Daclatasvir 60 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924832|NCT01016912|O2|Outcome|Daclatasvir 10 mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924833|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
924834|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
924835|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegINFα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924836|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924837|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin
924838|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924839|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924840|NCT01016912|O4|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care, pegIFNα/ribavirin.
924841|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924842|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
924843|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha (pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
924844|NCT01016912|O5|Outcome|Daclatasvir 60­ mg + pegIFNα­ + Ribavirin (Nonresponders)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
924845|NCT01016912|O4|Outcome|Daclatasvir 10­ mg+ pegIFNα + Ribavirin (Nonresponders)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection once weekly. Nonresponders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα/ribavirin.
924846|NCT01016912|O3|Outcome|Daclatasvir 60­ mg + pegIFNα + Ribavirin (Treatment-naive)|Participants received 60 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin..
924847|NCT01016912|O2|Outcome|Daclatasvir 10­ mg + pegIFNα­ + Ribavirin (Treatment-naive)|Participants received 10 mg of daclatasvir, once daily, coadministered with ribavirin, twice daily, and pegIFNα injection, once weekly. Treatment-naive participants were those who had never been exposed to any HCV therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924848|NCT01016912|O1|Outcome|Placebo + pegIFNα + Ribavirin (Treatment-naive)|Participants received a matching placebo of daclatasvir tablet, once daily coadministered with ribavirin, twice daily, and peginterferon alpha(pegIFNα) injection, once weekly. Treatment-naive participants were those who had never been exposed to any hepatitis C virus (HCV) therapy with interferon IFNα-containing regimens, including pegIFNα/ribavirin.
924849|NCT01016912|E5|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
924850|NCT01016912|E4|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Non-­Responders)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2b/ribavirin.
924851|NCT01016912|E3|Reported Event|Daclatasvir 60­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
924904|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924961|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
924852|NCT01016912|E2|Reported Event|Daclatasvir 10­ mg+pegIFNα+Ribavirin (Treatment Naive)|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFNα containing regimens including pegIFNα-2b/ribavirin.
924853|NCT01016912|E1|Reported Event|Placebo+pegIFNα +Ribavirin (Treatment Naive)|Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon IFNα containing regimens including pegIFNα-2b/ribavirin.
924854|NCT01016873|B4|Baseline|Total|Total of all reporting groups
924855|NCT01016873|B3|Baseline|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924856|NCT01016873|B2|Baseline|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924857|NCT01016873|B1|Baseline|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924858|NCT01016873|P3|Participant Flow|Sham IRay|"Sham 24 or 16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924859|NCT01016873|P2|Participant Flow|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924860|NCT01016873|P1|Participant Flow|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924861|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924862|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924863|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924864|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924865|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924866|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924867|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924868|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924869|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924870|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924871|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924872|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924881|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924882|NCT01016873|O3|Outcome|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924883|NCT01016873|O2|Outcome|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924884|NCT01016873|O1|Outcome|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924885|NCT01016873|E3|Reported Event|Sham IRay|"Sham 16 or 24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924886|NCT01016873|E2|Reported Event|24 Gy IRay|"24 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924887|NCT01016873|E1|Reported Event|16 Gy IRay|"16 Gy IRay + PRN Lucentis®~IRay: Low voltage stereotactic radiotherapy system"
924888|NCT01016847|B3|Baseline|Total|Total of all reporting groups
924889|NCT01016847|B2|Baseline|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924890|NCT01016847|B1|Baseline|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924891|NCT01016847|P2|Participant Flow|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924892|NCT01016847|P1|Participant Flow|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924893|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924894|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924895|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924896|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924897|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924898|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924899|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924900|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924901|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924902|NCT01016847|O1|Outcome|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924903|NCT01016847|O2|Outcome|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
925121|NCT01015703|P5|Participant Flow|10 mg Dose|10 mg CoVaccine HT
924905|NCT01016847|E2|Reported Event|Sugar Pill|"High dose of inhaled steroid administered with sugar pill~Sugar pill: Sugar pill that looks like Montelukast that will be given Q day"
924906|NCT01016847|E1|Reported Event|Leukotriene Receptor Antagonist (LTRA) Montelukast|"Montelukast (LTRA) administered with moderate dose of inhaled steroid~Montelukast: 10 mg Q day"
924907|NCT01016834|B1|Baseline|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
924908|NCT01016834|P1|Participant Flow|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
924909|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
924910|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
924911|NCT01016834|O1|Outcome|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
924912|NCT01016834|E1|Reported Event|Sumavel DosePro|The primary study endpoint was overall subject satisfaction with Sumavel DosePro, based on a comparison of the subject’s self-reported answer to the single overall satisfaction question completed at the beginning of the study based on his or her pre-study triptan treatment versus at the end of their treatment period.
924913|NCT01016691|B4|Baseline|Total|Total of all reporting groups
924914|NCT01016691|B3|Baseline|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
924915|NCT01016691|B2|Baseline|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
924916|NCT01016691|B1|Baseline|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
924917|NCT01016691|P3|Participant Flow|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
924918|NCT01016691|P2|Participant Flow|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
924919|NCT01016691|P1|Participant Flow|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
924920|NCT01016691|O3|Outcome|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
924921|NCT01016691|O2|Outcome|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
924922|NCT01016691|O1|Outcome|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
924923|NCT01016691|E3|Reported Event|Placebo Device / Bimatoprost 0.03%|placebo device during first period, bimatoprost 0.03% during second period.
924924|NCT01016691|E2|Reported Event|Low Dose Drug Device / Bimatoprost 0.03%|low-dose drug device during first period, bimatoprost 0.03% during second period.
924925|NCT01016691|E1|Reported Event|High Dose Drug Device/ Bimatoprost 0.03%|high dose drug device during first period, bimatoprost 0.03% during second period.
924926|NCT01016678|B1|Baseline|Adolescents Age 12-17|All subjects were adolescent males and females with diagnosis of Migraine and a frequency of 1-8 migraines per month on average
924927|NCT01016678|P5|Participant Flow|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
924928|NCT01016678|P4|Participant Flow|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
924929|NCT01016678|P3|Participant Flow|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
924930|NCT01016678|P2|Participant Flow|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
924931|NCT01016678|P1|Participant Flow|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
924932|NCT01016678|O5|Outcome|Active, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~All migraines (up to four) will be treated with active treximet"
924954|NCT01016652|P1|Participant Flow|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
924933|NCT01016678|O4|Outcome|Placebo, Active, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First migraine will be treated with Placebo and the last three migraines will be treated with Active Treximet"
924934|NCT01016678|O3|Outcome|Active, Placebo, Active, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~The first migraine will be treated with Active Treximent and the second migraine with Placebo. The final two migraines will be treated with Active Treximet"
924935|NCT01016678|O2|Outcome|Active, Active, Placebo, Active|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First two migraines will be treated with Active Treximet and then the 3rd migraine will be treated with Placebo and the last 4th migraine will be treated with Treximet"
924936|NCT01016678|O1|Outcome|Active, Active, Active, Placebo|"Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.~First three migraines will be treated with Active Treximet and the last 4th migraine will be treated with Placebo"
924937|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
924938|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
924939|NCT01016678|O2|Outcome|Placebo|"Equivalent looking pill just like Treximet but only containing sugar, sugar pill."
924940|NCT01016678|O1|Outcome|Active Drug|Treximet 85mg Imitrex with 500mg Naproxen Sodium combination tablet for the treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hour period.
924941|NCT01016678|O4|Outcome|Migraine Attack 4|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
924942|NCT01016678|O3|Outcome|Migraine Attack 3|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
951242|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
924943|NCT01016678|O2|Outcome|Migraine Attack 2|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
924944|NCT01016678|O1|Outcome|Migraine Attack 1|"The participants were instructed to treat 4 migraine attacks in the trial and according to the randomization schedule could potentially treat 3 attacks with active study drug (sumatriptan/naproxen sodium) and 1 attack with placebo, with different placement of the placebo for every 10 subjects. There are also a group of subjects in which all attacks were treated with active study drug.~Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period."
924945|NCT01016678|E5|Reported Event|Active, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
924946|NCT01016678|E4|Reported Event|Placebo, Active, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
924947|NCT01016678|E3|Reported Event|Active, Placebo, Active, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
924948|NCT01016678|E2|Reported Event|Active, Active, Placebo, Active|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
924949|NCT01016678|E1|Reported Event|Active, Active, Active, Placebo|Treximet: 85mg Imitrex with 500mg Naproxen Sodium combination tablet for treatment of migraine headache. The adult dosage is 1 tab Q12H for migraine and no more than 2 tablets in a 24 hours period.
924950|NCT01016652|B3|Baseline|Total|Total of all reporting groups
924951|NCT01016652|B2|Baseline|Etafilcon A Sphere\ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
924952|NCT01016652|B1|Baseline|Etafilcon A Multifocal/ Etafilcon A Sphere|etafilcon A multifocal/ etafilcon A sphere Arm: The first test lens for this arm, etafilcon A multifocal, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted. Repeat for the second lens (sphere).
924953|NCT01016652|P2|Participant Flow|Etafilcon A Sphere/ Etafilcon A Multifocal|"etafilcon A sphere/ etafilcon A multifocal Arm: The first test lens for this arm, etafilcon A sphere, was dispensed on Day 0 and to be worn a minimum of 2 hours before the assessment scheduled 12-17 days after the lens was fitted.~Repeat for the second lens (multifocal)."
925122|NCT01015703|P4|Participant Flow|7 mg Dose|7 mg CoVaccine HT
924962|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
924963|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere wearers
924964|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal wearers
924965|NCT01016652|O2|Outcome|Etafilcon A Sphere|etafilcon A sphere worn
924966|NCT01016652|O1|Outcome|Etafilcon A Multifocal|etafilcon A multifocal worn.
924967|NCT01016652|E2|Reported Event|Etafilcon A Sphere|etafilcon A sphere worn
924968|NCT01016652|E1|Reported Event|Etafilcon A Multifocal|etafilcon A multifocal worn
924969|NCT01016600|B5|Baseline|Total|Total of all reporting groups
924970|NCT01016600|B4|Baseline|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924971|NCT01016600|B3|Baseline|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924972|NCT01016600|B2|Baseline|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924973|NCT01016600|B1|Baseline|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924974|NCT01016600|P4|Participant Flow|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924975|NCT01016600|P3|Participant Flow|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924976|NCT01016600|P2|Participant Flow|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924977|NCT01016600|P1|Participant Flow|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924978|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924979|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924980|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924981|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924982|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924983|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924984|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924985|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924986|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924987|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924988|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924989|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924990|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924991|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924992|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924993|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924994|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924995|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924996|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924997|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924998|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
924999|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925000|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925001|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925002|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925003|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925004|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925005|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925071|NCT01016067|E2|Reported Event|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925006|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925007|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925008|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925009|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925010|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925011|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925012|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925013|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925014|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925015|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925016|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925017|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925018|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925019|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925020|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925021|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925022|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925023|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925024|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925025|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925026|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925027|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925028|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925029|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925030|NCT01016600|O1|Outcome|Phase I Cohort|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925031|NCT01016600|O4|Outcome|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925032|NCT01016600|O3|Outcome|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925033|NCT01016600|O2|Outcome|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925034|NCT01016600|O1|Outcome|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925072|NCT01016067|E1|Reported Event|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925035|NCT01016600|E4|Reported Event|Phase II|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 (dose determined in Phase I) mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925036|NCT01016600|E3|Reported Event|Cohort 3|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925037|NCT01016600|E2|Reported Event|Cohort 2|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 50 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925038|NCT01016600|E1|Reported Event|Cohort 1|"Induction regimen (total 2 cycles)~Lenalidomide 50 mg PO daily days 1-28~Azacitidine 25 mg/m2 IV days 1-5~Maintenance Regimen~Lenalidomide 10 mg PO daily days 1-28~Azacitidine 75 mg/m2 IV days 1-5"
925039|NCT01016132|B1|Baseline|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
925040|NCT01016132|P1|Participant Flow|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
925041|NCT01016132|O1|Outcome|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
925042|NCT01016132|E1|Reported Event|All Participants|In this single group study, all participants wore an investigational lotrafilcon A silicone hydrogel, single-vision, soft contact lens in both eyes for a period of four weeks. Participants wore the study lenses at least as often as they wore their habitual lenses, and as prescribed by their eye care practitioners -- ie., on a daily wear, flex wear, or extended wear basis.
925043|NCT01016106|B3|Baseline|Total|Total of all reporting groups
925044|NCT01016106|B2|Baseline|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
925045|NCT01016106|B1|Baseline|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
925046|NCT01016106|P2|Participant Flow|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
925047|NCT01016106|P1|Participant Flow|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for deoxyribonucleic acid (DNA) analysis.
925048|NCT01016106|O2|Outcome|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
925049|NCT01016106|O1|Outcome|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
925050|NCT01016106|E2|Reported Event|AA Subjects With Atopic Dermatitis and Ichthyosis Vulgaris|African American subjects with a diagnosis of atopic dermatitis and ichthyosis vulgaris. Buccal swabs were obtained from each subject for DNA analysis.
925123|NCT01015703|P3|Participant Flow|5 mg Dose|5 mg CoVaccine HT
925124|NCT01015703|P2|Participant Flow|2 mg Dose|2 mg CoVaccine HT
925051|NCT01016106|E1|Reported Event|African American (AA) Control Subjects|African American subjects with no personal or family history of ichthyosis vulgaris or atopy. Buccal swabs were obtained from each subject for DNA analysis.
925052|NCT01016067|B3|Baseline|Total|Total of all reporting groups
925053|NCT01016067|B2|Baseline|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925054|NCT01016067|B1|Baseline|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925055|NCT01016067|P2|Participant Flow|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925056|NCT01016067|P1|Participant Flow|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925057|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925058|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925059|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925060|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925061|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925062|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925063|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925064|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925065|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925066|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925067|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925068|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
925069|NCT01016067|O2|Outcome|Autograft Bone|Patients received autograft bone with rigid internal fixation.
925070|NCT01016067|O1|Outcome|INFUSE/MASTERGRAFT|Patients received INFUSE/MASTERGRAFT granules with rigid internal fixation.
951243|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
925073|NCT01016015|B1|Baseline|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
925074|NCT01016015|P1|Participant Flow|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
925075|NCT01016015|O1|Outcome|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
925076|NCT01016015|E1|Reported Event|Cixutumumab and Temsirolimus|Patients receive cixutumumab IV over 60 minutes and temsirolimus IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
925077|NCT01015976|B1|Baseline|Active Drug|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
925078|NCT01015976|P2|Participant Flow|Control Group|"active drug~No surgery matched subjects"
925079|NCT01015976|P1|Participant Flow|Experimental|Post surgery group Sertraline : Single dose of 100mg sertraline
925080|NCT01015976|O1|Outcome|Control|"Single arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
925081|NCT01015976|E1|Reported Event|Active Drug|"Two arm study, all receive active drug~Sertraline : Single dose of 100mg sertraline"
925082|NCT01015820|B3|Baseline|Total|Total of all reporting groups
925083|NCT01015820|B2|Baseline|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925084|NCT01015820|B1|Baseline|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925085|NCT01015820|P2|Participant Flow|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925086|NCT01015820|P1|Participant Flow|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an esophagogastroduodenoscopy (EGD) with endoscopic ultrasound (EUS). During the EUS, blood flow was measured in the duodenum with the Four-dimensional Elastic Light-Scattering Fingerprinting (4D-ELF) device.
925087|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925088|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925089|NCT01015820|O2|Outcome|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925090|NCT01015820|O1|Outcome|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925091|NCT01015820|E2|Reported Event|Control Group|Participants in this group were without pancreatic adenocarcinoma. Participants in the control group received an EGD with EUS for the indication of abdominal pain. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925125|NCT01015703|P1|Participant Flow|1 mg Dose|1 mg CoVaccine HT
925092|NCT01015820|E1|Reported Event|Cancer Group|Participants in this group had pathologically confirmed pancreatic adenocarcinoma. They received an EGD with EUS. During the EUS, blood flow was measured in the duodenum with the 4D-ELF device.
925093|NCT01015807|B4|Baseline|Total|Total of all reporting groups
925094|NCT01015807|B3|Baseline|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
925095|NCT01015807|B2|Baseline|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
925096|NCT01015807|B1|Baseline|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
925097|NCT01015807|P3|Participant Flow|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
925098|NCT01015807|P2|Participant Flow|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
925099|NCT01015807|P1|Participant Flow|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
925100|NCT01015807|O3|Outcome|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
925101|NCT01015807|O2|Outcome|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
925102|NCT01015807|O1|Outcome|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
925103|NCT01015807|E3|Reported Event|Clo-TAP (Bupi + Clon)|"2x20mL 0.375% Bupivacaine + 2x1mL Clonidine = 150mg Bupivacaine + 150µg Clonidine~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine~Clonidine: 2 x 1ml Clonidine = 150 µg Clonidine"
925104|NCT01015807|E2|Reported Event|TAP (Bupi)|"2x20mL 0.375% Bupivacaine + 2x1mL of 0.9% NaCl = 150mg Bupivacaine + Clonidine Placebo~Clonidine Placebo: 2 x 1mL 0.9% NaCl~Bupivacaine: 2 x 20mL 0.375% Bupivacaine = 150 mg Bupivacaine"
925105|NCT01015807|E1|Reported Event|Placebo|"Sterile Saline used for TAP block = Bupivacaine Placebo + Clonidine Placebo~Bupivacaine Placebo: 2 x 20mL 0.9% NaCl~Clonidine Placebo: 2 x 1mL 0.9% NaCl"
925106|NCT01015781|B3|Baseline|Total|Total of all reporting groups
925107|NCT01015781|B2|Baseline|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
925108|NCT01015781|B1|Baseline|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
925109|NCT01015781|P2|Participant Flow|Wait List Control|Wait List Control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
925110|NCT01015781|P1|Participant Flow|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
925111|NCT01015781|O2|Outcome|Wait List Control|VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Wait List Control subjects also can be referred for other clinical services as deemed appropriate.
925112|NCT01015781|O1|Outcome|Immediate Care|"The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
925113|NCT01015781|E2|Reported Event|Wait List Control|Wait List control: VA audiologists typically (a) perform an audiologic evaluation; (b) fit hearing aids if necessary; and (c) provide basic information about tinnitus in the form of one-time, one-on-one informational counseling and/or a tinnitus handout. We therefore will provide these procedures for subjects who are randomized to receive usual care. Usual care subjects also can be referred for other clinical services as deemed appropriate.
925114|NCT01015781|E1|Reported Event|Immediate Care|"Immediate Care: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: 1) Triage; 2) Audiologic Evaluation; 3) Group Education; 4) Interdisciplinary Evaluation; 5) Individualized Support"
925115|NCT01015703|B6|Baseline|Total|Total of all reporting groups
925116|NCT01015703|B5|Baseline|10 mg Dose|10 mg CoVaccine HT
925117|NCT01015703|B4|Baseline|7 mg Dose|7 mg CoVaccine HT
925118|NCT01015703|B3|Baseline|5 mg Dose|5 mg CoVaccine HT
925119|NCT01015703|B2|Baseline|2 mg Dose|2 mg CoVaccine HT
925120|NCT01015703|B1|Baseline|1 mg Dose|1 mg CoVaccine HT
925137|NCT01015677|B3|Baseline|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925138|NCT01015677|B2|Baseline|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925139|NCT01015677|B1|Baseline|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925140|NCT01015677|P3|Participant Flow|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925141|NCT01015677|P2|Participant Flow|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925142|NCT01015677|P1|Participant Flow|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925143|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925144|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925145|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925146|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
927312|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
925147|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925148|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925149|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925150|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925151|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925152|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925153|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925154|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925155|NCT01015677|O3|Outcome|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925156|NCT01015677|O2|Outcome|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925157|NCT01015677|O1|Outcome|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925158|NCT01015677|E3|Reported Event|Placebo|Matching placebo for MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925159|NCT01015677|E2|Reported Event|17-β Estradiol 1 mg|17β-estradiol 1 mg and matching placebo for MK-6913 75 mg once daily for 4 weeks
925160|NCT01015677|E1|Reported Event|MK-6913 75 mg|MK-6913 75 mg and matching placebo for 17β-estradiol 1 mg once daily for 4 weeks
925161|NCT01015638|B3|Baseline|Total|Total of all reporting groups
925162|NCT01015638|B2|Baseline|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925163|NCT01015638|B1|Baseline|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925164|NCT01015638|P2|Participant Flow|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925165|NCT01015638|P1|Participant Flow|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925166|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925167|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925168|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925169|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925170|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925171|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925172|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925173|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925174|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925175|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925176|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925177|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925178|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925179|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925180|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925181|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925182|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925183|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925184|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925185|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925186|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925187|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925188|NCT01015638|O2|Outcome|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925189|NCT01015638|O1|Outcome|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925190|NCT01015638|E2|Reported Event|Clindamycin Phosphate and BPO 2.5% Gel|Once Daily application of clindamycin phosphate and benzoyl peroxide 2.5% gel.
925191|NCT01015638|E1|Reported Event|Clindamycin and BPO 5% Gel|Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide 5% gel.
925192|NCT01015560|B1|Baseline|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
925193|NCT01015560|P1|Participant Flow|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
925194|NCT01015560|O1|Outcome|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
925195|NCT01015560|E1|Reported Event|MLN 1202|MLN1202 8mg/kg IV Days 1, 15, 29 given as one 6-week cycle
925196|NCT01015534|B3|Baseline|Total|Total of all reporting groups
925197|NCT01015534|B2|Baseline|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
925198|NCT01015534|B1|Baseline|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
925199|NCT01015534|P2|Participant Flow|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
925200|NCT01015534|P1|Participant Flow|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
925201|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
925202|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks,and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
925203|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
925204|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
925205|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation, at a dose of 30 Gy in 10 daily fractions over 2 weeks
925206|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
925207|NCT01015534|O2|Outcome|Whole Brain Irradiation|Whole brain irradiation,at a dose of 30 Gy in 10 daily fractions over 2 weeks
925208|NCT01015534|O1|Outcome|Whole Brain Irradiation and Temozolomide|Patients received Whole brain irradiation at a dose of 30 Gy in 10 daily fractions over 2 weeks, and a fixed dose of oral Temozolomide, 1h before each fraction of whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without adjuvant cycles of Temozolomide.
925209|NCT01015534|E2|Reported Event|Whole Brain Irradiation|Whole brain irradiation, 1 fraction of 3 Gy x 5 days each week for 2 weeks, Monday to Friday.
925210|NCT01015534|E1|Reported Event|Whole Brain Irradiation and Temozolomide|Whole brain irradiation, 1 fraction of 3 Gy x 5 days of each week for 2 weeks, Monday to Friday and a fixed dose of oral temozolomide, 1h before each daily fraction of Whole brain irradiation, 200 mg on Monday, Wednesday, Friday; 300 mg on Tuesday, and Thursday. Without extra cycles of Temozolomide.
925211|NCT01015443|B3|Baseline|Total|Total of all reporting groups
925212|NCT01015443|B2|Baseline|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925213|NCT01015443|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925214|NCT01015443|P2|Participant Flow|Saline + Placebo + BSC|A single IV infusion of 0.9 percent (%) sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925215|NCT01015443|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Supportive Care|A single intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 microgram (mcg) and then at 6-Week interval, beginning at Week 14 (maintenance phase) until disease progression (PD) is documented or the subject discontinued for any other reason. The best supportive care (BSC) was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925553|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925216|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925217|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925218|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925219|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925220|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925221|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925222|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925223|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925224|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925225|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925226|NCT01015443|O2|Outcome|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925303|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925227|NCT01015443|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925228|NCT01015443|E2|Reported Event|Saline + Placebo + BSC|A single IV infusion of 0.9% sodium chloride (saline) was administered 3 days prior to first placebo vaccination. After receiving saline solution, subjects received 8 consecutive weekly subcutaneous vaccinations with placebo at Week 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance treatment at 6-Week intervals, beginning at Week 14, until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925229|NCT01015443|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+BSC|A single IV infusion of 300 mg/m^2 (to a maximum 600 mg) of low dose cyclophosphamide was given 3 days prior to first tecemotide (L-BLP25) vaccination. After receiving single low dose cyclophosphamide, subjects received 8 consecutive weekly (Week 1, 2, 3, 4, 5, 6, 7, and 8 primary treatment phase) subcutaneous tecemotide (L-BLP25) vaccinations at a dose of 918 mcg and then at 6-Week interval, beginning at Week 14 (maintenance phase) until PD is documented or the subject discontinued for any other reason. The BSC was provided as per the investigator’s discretion and was not limited to palliative radiation, psychosocial support, analgesics and nutritional support.
925230|NCT01015326|B3|Baseline|Total|Total of all reporting groups
925231|NCT01015326|B2|Baseline|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
925232|NCT01015326|B1|Baseline|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
925233|NCT01015326|P2|Participant Flow|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked through interview and questionnaire to rate items according to how important they are to the patient's health-related quality of life (HRQL).~Questionnaire : Administered questionnaire"
925234|NCT01015326|P1|Participant Flow|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
925235|NCT01015326|O2|Outcome|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
925236|NCT01015326|O1|Outcome|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
925261|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925237|NCT01015326|E2|Reported Event|Patient Interviews|"Patient cohort will consist of those treated with an epidermal growth factor receptor inhibitor (EGFRI) and referred to a specialized dermatology clinic for skin rash management. Patients will be asked open-ended questions about symptoms and issues as they relate to their health-related quality of life (HRQL) to elicit personal experiences about how EGFRI skin toxicities and its treatment affects patients. Patients will be asked through interview and questionnaire to rate items according to how often they are experienced and how important they are to the patient.~Questionnaire : Administered questionnaire"
925238|NCT01015326|E1|Reported Event|Expert Interviews|"Expert cohort consists of providers with expertise in administering epidermal growth factor receptor inhibitors (EGFRI) or treating patients with EGFRI-associated skin toxicities. Experts will be asked open-ended questions about symptoms and issues as they relate to health-related quality of life (HRQL) in patients with EFGRI skin toxicities. Experts will then be presented with a pool of potential items and will be asked through interview and questionnaire to relate items according to how common and how important they are when occurring in patients with this condition.~Questionnaire : Administered questionnaire"
925239|NCT01015287|B3|Baseline|Total|Total of all reporting groups
925240|NCT01015287|B2|Baseline|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925304|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925241|NCT01015287|B1|Baseline|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925242|NCT01015287|P2|Participant Flow|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925243|NCT01015287|P1|Participant Flow|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925244|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925245|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925246|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925247|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925248|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925249|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925250|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925251|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925252|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925253|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925254|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925255|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925256|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925257|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925258|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925259|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925260|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925262|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925263|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925264|NCT01015287|O2|Outcome|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925265|NCT01015287|O1|Outcome|Non Pre-treatment|A placebo oral LD was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925266|NCT01015287|E2|Reported Event|Pre-treatment|A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925554|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
927313|NCT01011868|O1|Outcome|Placebo|Oral Placebo
925267|NCT01015287|E1|Reported Event|Non Pre-treatment|A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
925268|NCT01015170|B1|Baseline|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
925269|NCT01015170|P1|Participant Flow|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.~bupropion HCl: 150mg BID for up to 8 weeks + counseling"
925270|NCT01015170|O1|Outcome|Buproprion & Behavioural Support|8 weeks of buproprion-SR + brief counselling for smoking cessation
925271|NCT01015170|O1|Outcome|Bupropion HCl and Counselling|Bupropion HCl Up to 8 week of bupropion SR (150mg BID) + counseling.
925272|NCT01015170|O1|Outcome|Nicotine Replacement & Behavioural Support|"Nicotine Replacement Therapy: Transdermal nicotine patch, nicotine gum, nicotine inhaler, nicotine lozenge~& Smoking cessation counselling-relapse prevention strategies."
925273|NCT01015170|E1|Reported Event|Bupropion HCl|"Up to 8 week of bupropion SR (150mg BID) + counseling.~bupropion HCl: 150mg BID for up to 8 weeks + counseling"
925274|NCT01015131|B1|Baseline|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925275|NCT01015131|P1|Participant Flow|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925276|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925277|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925278|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925279|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925280|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925281|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925282|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925283|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925284|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925285|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925286|NCT01015131|O1|Outcome|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925287|NCT01015131|E1|Reported Event|All Participants|Participants who underwent 18-FLT positron emission tomography (PET) and standard of care (SOC) neo-adjuvant chemotherapy
925288|NCT01015118|B3|Baseline|Total|Total of all reporting groups
925289|NCT01015118|B2|Baseline|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925290|NCT01015118|B1|Baseline|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925291|NCT01015118|P2|Participant Flow|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925292|NCT01015118|P1|Participant Flow|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925293|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925294|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925295|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925296|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925297|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925298|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925299|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925300|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925301|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925302|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925555|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925305|NCT01015118|O2|Outcome|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925306|NCT01015118|O1|Outcome|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925307|NCT01015118|E2|Reported Event|Placebo|Patients to receive two 100 mg capsules identical to those containing Nintedanib, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925308|NCT01015118|E1|Reported Event|Nintedanib|Patients to receive Nintedanib 200 mg, taken twice daily, except the day of chemotherapy (carboplatin and paclitaxel) infusion, every 21 days for six courses.
925309|NCT01014988|B7|Baseline|Total|Total of all reporting groups
925310|NCT01014988|B6|Baseline|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925311|NCT01014988|B5|Baseline|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925312|NCT01014988|B4|Baseline|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925313|NCT01014988|B3|Baseline|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925314|NCT01014988|B2|Baseline|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925315|NCT01014988|B1|Baseline|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925316|NCT01014988|P6|Participant Flow|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925317|NCT01014988|P5|Participant Flow|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925318|NCT01014988|P4|Participant Flow|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925319|NCT01014988|P3|Participant Flow|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925320|NCT01014988|P2|Participant Flow|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925321|NCT01014988|P1|Participant Flow|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 milligrams (mg) zanamivir by intravenous (IV) infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925505|NCT01014936|B1|Baseline|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925322|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925323|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925324|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925325|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925326|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925327|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925328|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925329|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925330|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925331|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925332|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925333|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925334|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925335|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925336|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925337|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925338|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925339|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925340|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925341|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925342|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925343|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925344|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925345|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925346|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925347|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925348|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925349|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925350|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925351|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925352|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925353|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925354|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925355|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925356|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925357|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925358|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925359|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925360|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925361|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925362|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925363|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925364|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925365|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925366|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925367|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925368|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925369|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925370|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925371|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925372|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925373|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925374|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925375|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925376|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925377|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925378|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925379|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925380|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925381|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925382|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925383|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925384|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925385|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925386|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925387|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925388|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925389|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925390|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925391|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925392|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925393|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925394|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925395|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925396|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925397|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925398|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925399|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925400|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925401|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925402|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925403|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925404|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925405|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925406|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
951244|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
925407|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925408|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925409|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925410|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925411|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925412|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925413|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925414|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925415|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925416|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925417|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925418|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925419|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925420|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925421|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925422|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925423|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925424|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925425|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
925426|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
925556|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925427|NCT01014988|O6|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925428|NCT01014988|O5|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925429|NCT01014988|O4|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925430|NCT01014988|O3|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925431|NCT01014988|O2|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925432|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925433|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925434|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925435|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925436|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925437|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925438|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
925439|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
925440|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925441|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925539|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925442|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925443|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925444|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925445|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
925446|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
925514|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925447|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925448|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925449|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925450|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925451|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925452|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
925453|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
925454|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925455|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925456|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925457|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925458|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925459|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
925460|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
925461|NCT01014988|O7|Outcome|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925540|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925462|NCT01014988|O6|Outcome|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925463|NCT01014988|O5|Outcome|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925464|NCT01014988|O4|Outcome|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925465|NCT01014988|O3|Outcome|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925466|NCT01014988|O2|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir >5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for >5 days and up to 10 days if viral shedding or clinical symptoms warranted further treatment.
925467|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older); Zanamivir <=5 Days|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days.
927314|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
925468|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925469|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925470|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925471|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925472|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925473|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925474|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925475|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925476|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925477|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925478|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925479|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925541|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925480|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925481|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925482|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925483|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925484|NCT01014988|O2|Outcome|Cohorts 1-5: Pediatrics/Adolescents (6 Months to <18 Years)|Participants 6 months to <18 years of age received 14 mg/kg zanamivir (participants from 6 months to <6 years of age) or 12 mg/kg zanamivir (participants from 6 years to <18 years of age) with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function for 5 days. Treatment could be extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925552|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925485|NCT01014988|O1|Outcome|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925486|NCT01014988|E6|Reported Event|Cohort 5: Adolescents (13 to <18 Years of Age)|Participants 13 to <18 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925487|NCT01014988|E5|Reported Event|Cohort 4: Children (6 to <13 Years of Age)|Participants 6 years to <13 years of age received 12 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925488|NCT01014988|E4|Reported Event|Cohort 3: Children (2 to <6 Years of Age)|Participants 2 years to <6 years of age received 14 mg/kg zanamivir with a maximum dose of 600 mg by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925489|NCT01014988|E3|Reported Event|Cohort 2: Children (1 to <2 Years of Age)|Participants 1 year to <2 years of age received 14 mg/kg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925490|NCT01014988|E2|Reported Event|Cohort 1: Infants (6 Months to <1 Year of Age)|Participants 6 months to <1 year of age received 14 mg per kilogram (mg/kg) zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925491|NCT01014988|E1|Reported Event|Cohort 6: Adults (18 Years and Older)|Participants >=18 years of age received 600 mg zanamivir by IV infusion over 30 minutes twice daily, adjusted for renal function, for 5 days. Treatment could have been extended for up to 5 additional days if viral shedding or clinical symptoms warranted further treatment.
925492|NCT01014975|B1|Baseline|Safety Population|Plasmin (Human): Plasmin (Human), 20 mg, 40 mg, or 80 mg, delivered through a catheter into a thrombus
925493|NCT01014975|P3|Participant Flow|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
925494|NCT01014975|P2|Participant Flow|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
925495|NCT01014975|P1|Participant Flow|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
925496|NCT01014975|O3|Outcome|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
925497|NCT01014975|O2|Outcome|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
925498|NCT01014975|O1|Outcome|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
925499|NCT01014975|E3|Reported Event|80 mg Plasmin (Human)|"80 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 80 mg, delivered through a catheter into a thrombus"
925500|NCT01014975|E2|Reported Event|40 mg Plasmin (Human)|"40 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 40 mg, delivered through a catheter into a thrombus"
925501|NCT01014975|E1|Reported Event|20 mg Plasmin (Human)|"20 mg of Plasmin (Human)~Plasmin (Human): Plasmin (Human), 20 mg, delivered through a catheter into a thrombus"
925502|NCT01014936|B4|Baseline|Total|Total of all reporting groups
925503|NCT01014936|B3|Baseline|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925504|NCT01014936|B2|Baseline|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
927255|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
925506|NCT01014936|P3|Participant Flow|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925507|NCT01014936|P2|Participant Flow|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925508|NCT01014936|P1|Participant Flow|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925509|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925510|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925511|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925512|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925513|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
951245|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
925515|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925516|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925517|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925518|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925519|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925520|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925521|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925522|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925523|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925524|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925525|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925526|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925527|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925528|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925529|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925530|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925531|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925532|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925533|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925534|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925535|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925536|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925537|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925538|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
928308|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
925542|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925543|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925544|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925545|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925546|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925547|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925548|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925549|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925550|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925551|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
951246|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
925557|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
925558|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925559|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925560|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925561|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925562|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925563|NCT01014936|O9|Outcome|MSC2156119J 115 mg Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925564|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925565|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925566|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925567|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925568|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925569|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925570|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925571|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925572|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925573|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925574|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925575|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925576|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925577|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925578|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925579|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925580|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925581|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925582|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925583|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925584|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925585|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925586|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925587|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925588|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925589|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
927256|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
925590|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925591|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925592|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925593|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925594|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925595|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925596|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925597|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925598|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925599|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925600|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925601|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925602|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925603|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925604|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925605|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925606|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925607|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925608|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925609|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925610|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925611|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925612|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925613|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925614|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
925615|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925616|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925617|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925618|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925619|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925620|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925621|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925622|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925623|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925624|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925625|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925626|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925627|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925628|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925629|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925630|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925631|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925632|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925633|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925634|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925635|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925636|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925637|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925638|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925639|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925640|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925641|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925642|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925643|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
925644|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925645|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925646|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925647|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925648|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925649|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925650|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925651|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925652|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925653|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925654|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925655|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925656|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925657|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925658|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925659|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925660|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925661|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925662|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925663|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925664|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925665|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925666|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925667|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925668|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925669|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925670|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925671|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925672|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925673|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925674|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925675|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925676|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925677|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
928309|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
925678|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925679|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925680|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925681|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925682|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925683|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925684|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925685|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925686|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925687|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925688|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925689|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925690|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925691|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925692|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925693|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925694|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925695|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925696|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925697|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925698|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925699|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925700|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
925701|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925702|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925703|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925704|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925705|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925706|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925707|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925708|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925709|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925710|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925711|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925712|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925713|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925714|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925715|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925716|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925717|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925718|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925719|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925720|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925721|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925722|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925723|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925724|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925725|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925726|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925727|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (Tablet) with food.
925728|NCT01014936|O7|Outcome|MSC2156119J 1400 mg Fed|Subjects were administered with micronized MSC2156119J 1400 mg with food.
925729|NCT01014936|O6|Outcome|MSC2156119J 1200 mg Fasted|Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state.
925730|NCT01014936|O5|Outcome|MSC2156119J 1000 mg Fed|Subjects were administered with micronized MSC2156119J 1000 mg with food.
925731|NCT01014936|O4|Outcome|MSC2156119J 700 mg Fed|Subjects were administered with micronized MSC2156119J 700 mg with food.
925732|NCT01014936|O3|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food
925733|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg in the fasted state.
925734|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food
925735|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925736|NCT01014936|O8|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925737|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925738|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925739|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925740|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925741|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925742|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925743|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925744|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925745|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925746|NCT01014936|O10|Outcome|MSC2156119J 115 mg Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925747|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925748|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925749|NCT01014936|O7|Outcome|MSC2156119J 400 mg Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925750|NCT01014936|O6|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925751|NCT01014936|O5|Outcome|MSC2156119J 215 mg Fed|Subjects were administered with micronized MSC2156119J 215 mg with food.
925752|NCT01014936|O4|Outcome|MSC2156119J 145 mg Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925753|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925754|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925755|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925756|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925757|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925758|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925759|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925760|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925761|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925762|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925763|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925764|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925765|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925766|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
928310|NCT01009333|E3|Reported Event|High InterStim Rate Setting at 25 Hz|
925767|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925768|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925769|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925770|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925771|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925772|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925773|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925774|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925775|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925776|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925777|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925778|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925779|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925780|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925781|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925782|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925783|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925784|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925785|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925786|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
925787|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925788|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925789|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925790|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925791|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925792|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925793|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925794|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925795|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925796|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925797|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925798|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925799|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925800|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925801|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925802|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925803|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925804|NCT01014936|O9|Outcome|MSC2156119J 60 mg Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg in the fasted state.
925805|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925806|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925807|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925808|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925809|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925810|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925811|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925812|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925813|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925814|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925815|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925816|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925817|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925818|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925819|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925820|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925821|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
927315|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
925822|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925823|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925824|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925825|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925826|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925827|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925828|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925829|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925830|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925831|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925832|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925833|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925834|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925835|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925836|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925837|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925838|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925839|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925840|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food
925841|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet) with food.
925842|NCT01014936|O7|Outcome|MSC2156119J 1400 mg Fed|Subjects were administered with micronized MSC2156119J 1400 mg with food.
925843|NCT01014936|O6|Outcome|MSC2156119J 1200 mg Fasted|Subjects were administered with micronized MSC2156119J 1200 mg in the fasted state.
925844|NCT01014936|O5|Outcome|MSC2156119J 1000 mg Fed|Subjects were administered with micronized MSC2156119J 1000 mg with food.
925845|NCT01014936|O4|Outcome|MSC2156119J 700 mg Fed|Subjects were administered with micronized MSC2156119J 700 mg with food.
925846|NCT01014936|O3|Outcome|MSC2156119J 500 mg Fed|Subjects were administered with micronized MSC2156119J 500 mg with food.
925847|NCT01014936|O2|Outcome|MSC2156119J 500 mg Fasted|Subjects were administered with micronized MSC2156119J 500 mg in the fasted state.
925848|NCT01014936|O1|Outcome|MSC2156119J 300 mg Fed|Subjects were administered with micronized MSC2156119J 300 mg with food.
925849|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925850|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925851|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925852|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925853|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925854|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
927257|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
925855|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925856|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925857|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925858|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925859|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925860|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925861|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925862|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state
925863|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925864|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925865|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925866|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925867|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925868|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925869|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925870|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925871|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925872|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925873|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925874|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925875|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925876|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925877|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925878|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925879|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925880|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925881|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925882|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925883|NCT01014936|O3|Outcome|MSC2156119J 130 mg Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925884|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925885|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925886|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925887|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925888|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925889|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925890|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925891|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925892|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925893|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925894|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925895|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925896|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925897|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925898|NCT01014936|O8|Outcome|MSC2156119J 500 mg Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
928312|NCT01009333|E1|Reported Event|Low InterStim Rate Setting at 5.2 Hz|
925899|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925900|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
925901|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925902|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925903|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925904|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925905|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925906|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925907|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925908|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925909|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925910|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925911|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925912|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925913|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925914|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925915|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925916|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925917|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925918|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925919|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925920|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925921|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925922|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925923|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925924|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925925|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925926|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925927|NCT01014936|O7|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925928|NCT01014936|O6|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925929|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925930|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925931|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925932|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925933|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925934|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925935|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925936|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925937|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925938|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925939|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925940|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925941|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925942|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925943|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925944|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925945|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925946|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925947|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925948|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925949|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925950|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925951|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925952|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925953|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925954|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
927316|NCT01011868|O1|Outcome|Placebo|Oral Placebo
925955|NCT01014936|O8|Outcome|MSC2156119J 500 mg: Fed (Tablet)|Subjects were administered with micronized MSC2156119J 500 mg (tablet formulation) with food.
925956|NCT01014936|O7|Outcome|MSC2156119J 1400 mg: Fed|Subjects were administered with micronized MSC2156119J 1400 mg (capsule formulation) with food.
925957|NCT01014936|O6|Outcome|MSC2156119J 1200 mg: Fasted|Subjects were administered with micronized MSC2156119J 1200 mg (capsule formulation) in the fasted state.
925958|NCT01014936|O5|Outcome|MSC2156119J 1000 mg: Fed|Subjects were administered with micronized MSC2156119J 1000 mg (capsule formulation) with food.
925959|NCT01014936|O4|Outcome|MSC2156119J 700 mg: Fed|Subjects were administered with micronized MSC2156119J 700 mg (capsule formulation) with food.
925960|NCT01014936|O3|Outcome|MSC2156119J 500 mg: Fed|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) with food.
925961|NCT01014936|O2|Outcome|MSC2156119J 500 mg: Fasted|Subjects were administered with micronized MSC2156119J 500 mg (capsule formulation) in the fasted state.
925962|NCT01014936|O1|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925963|NCT01014936|O9|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925964|NCT01014936|O8|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925965|NCT01014936|O7|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925966|NCT01014936|O6|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925967|NCT01014936|O5|Outcome|MSC2156119J 315 mg: Fed|Subjects were administered with micronized MSC2156119J 315 mg (capsule formulation) with food.
925968|NCT01014936|O4|Outcome|MSC2156119J 175 mg: Fed|Subjects were administered with micronized MSC2156119J 175 mg (capsule formulation) with food.
925969|NCT01014936|O3|Outcome|MSC2156119J 130 mg: Fed|Subjects were administered with micronized MSC2156119J 130 mg (capsule formulation) with food.
925970|NCT01014936|O2|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925971|NCT01014936|O1|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925972|NCT01014936|O12|Outcome|MSC2156119J 230 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 230 mg (capsule formulation) in the fasted state.
925973|NCT01014936|O11|Outcome|MSC2156119J 115 mg: Fed|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) with food.
925974|NCT01014936|O10|Outcome|MSC2156119J 115 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 115 mg (capsule formulation) in the fasted state.
925975|NCT01014936|O9|Outcome|MSC2156119J 60 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 60 mg (capsule formulation) in the fasted state.
925976|NCT01014936|O8|Outcome|MSC2156119J 30 mg: Fasted|Subjects were administered with non-micronized MSC2156119J 30 mg (capsule formulation) in the fasted state.
925977|NCT01014936|O7|Outcome|MSC2156119J 400 mg: Fed|Subjects were administered with micronized MSC2156119J 400 mg (capsule formulation) with food.
925978|NCT01014936|O6|Outcome|MSC2156119J 300 mg: Fed|Subjects were administered with micronized MSC2156119J 300 mg (capsule formulation) with food.
925979|NCT01014936|O5|Outcome|MSC2156119J 215 mg: Fed|Subjects were administered with micronized MSC2156119J 215 mg (capsule formulation) with food.
925980|NCT01014936|O4|Outcome|MSC2156119J 145 mg: Fed|Subjects were administered with micronized MSC2156119J 145 mg (capsule formulation) with food.
925981|NCT01014936|O3|Outcome|MSC2156119J 100 mg: Fed|Subjects were administered with micronized MSC2156119J 100 mg (capsule formulation) with food.
925982|NCT01014936|O2|Outcome|MSC2156119J 60 mg: Fed|Subjects were administered with micronized MSC2156119J 60 mg (capsule formulation) with food.
925983|NCT01014936|O1|Outcome|MSC2156119J 30 mg: Fed|Subjects were administered with micronized MSC2156119J 30 mg (capsule formulation) with food.
925984|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
926036|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
925985|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925986|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925987|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925988|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925989|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925990|NCT01014936|O1|Outcome|MSC2156119J Combined|All subjects who were administered with micronized or non-micronized MSC2156119J (capsule or tablet formulation) in any of the three regimens.
925991|NCT01014936|O3|Outcome|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925992|NCT01014936|O2|Outcome|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925993|NCT01014936|O1|Outcome|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925994|NCT01014936|E3|Reported Event|MSC2156119J Regimen 3|Subjects were administered with micronized MSC2156119J in dose ranging from 300 mg to 1400 mg (capsule or tablet formulation) once daily for 21 days (21-day cycle) in Regimen 3.
925995|NCT01014936|E2|Reported Event|MSC2156119J Regimen 2|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 60 mg to 315 mg (capsule formulation) once daily 3 times per week for 3 weeks (21-day cycle) in Regimen 2.
925996|NCT01014936|E1|Reported Event|MSC2156119J Regimen 1|Subjects were administered with micronized or non-micronized MSC2156119J in dose ranging from 30 mg to 400 mg (capsule formulation) once daily for 14 days, followed by 7 days with no treatment (21-day cycle) in Regimen 1.
925997|NCT01014910|B3|Baseline|Total|Total of all reporting groups
925998|NCT01014910|B2|Baseline|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
925999|NCT01014910|B1|Baseline|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
926000|NCT01014910|P2|Participant Flow|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
926001|NCT01014910|P1|Participant Flow|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
926002|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
926003|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
926037|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
926004|NCT01014910|O2|Outcome|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
926005|NCT01014910|O1|Outcome|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
926006|NCT01014910|E2|Reported Event|Intermittent Pulse Oximetry Monitoring|"Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.~Intermittent pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved."
926050|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926051|NCT01014689|E2|Reported Event|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926007|NCT01014910|E1|Reported Event|Continuous Pulse Oximetry Monitoring|"Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.~Continuous pulse oximetry monitoring: Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen."
926008|NCT01014871|B1|Baseline|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
926009|NCT01014871|P1|Participant Flow|Vistabel/Azzalure|"at Baseline:~1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead~1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
926010|NCT01014871|O2|Outcome|Vistabel|"at Baseline:~- 1 injection of 8 Speywood units of Vistabel (2 points of 4 Speywood units) in the other side of the forehead"
926011|NCT01014871|O1|Outcome|Azzalure|"at Baseline:~- 1 injection of 20 units of Azzalure (2 points of 10 units) in 1 side of the forehead"
926012|NCT01014871|E2|Reported Event|Vistabel|intra-individual comparison
926013|NCT01014871|E1|Reported Event|Azzalure|intra-individual comparison
926014|NCT01014741|B3|Baseline|Total|Total of all reporting groups
926015|NCT01014741|B2|Baseline|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
926016|NCT01014741|B1|Baseline|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
926017|NCT01014741|P2|Participant Flow|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
926018|NCT01014741|P1|Participant Flow|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after pulmonary vein isolation (PVI) isolation prior to complex fractionated atrial electrograms (CFAE) ablation
926019|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
926020|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
926021|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
926022|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
926023|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
926024|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
926025|NCT01014741|O2|Outcome|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
926026|NCT01014741|O1|Outcome|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
926027|NCT01014741|E2|Reported Event|Placebo Arm|Placebo: Placebo after PVI isolation prior to CFAE ablation.
926028|NCT01014741|E1|Reported Event|Ibutilide Arm|Ibutilide: 0.25mg IV ibutilide after PVI isolation prior to CFAE ablation.
926029|NCT01014728|B3|Baseline|Total|Total of all reporting groups
926030|NCT01014728|B2|Baseline|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
926031|NCT01014728|B1|Baseline|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
926032|NCT01014728|P2|Participant Flow|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
926033|NCT01014728|P1|Participant Flow|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
926034|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
926035|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
927258|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
926038|NCT01014728|O2|Outcome|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
926039|NCT01014728|O1|Outcome|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
926040|NCT01014728|E2|Reported Event|Inhalation Anesthesia|After induction, the inhalation anesthesia group received sevoflurane (1% to 3%) for endoscopic sinus surgery.
926041|NCT01014728|E1|Reported Event|Intravenous Anesthesia|After induction, the intravenous anesthesia group received an infusion of propofol (100-200 μg/kg/min) for endoscopic sinus surgery.
926042|NCT01014689|B3|Baseline|Total|Total of all reporting groups
926043|NCT01014689|B2|Baseline|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926044|NCT01014689|B1|Baseline|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926045|NCT01014689|P2|Participant Flow|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926046|NCT01014689|P1|Participant Flow|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926047|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926048|NCT01014689|O1|Outcome|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926049|NCT01014689|O2|Outcome|Adapalene 0.1% / BPO 2.5% Vehicle Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926052|NCT01014689|E1|Reported Event|Adapalene 0.1% / BPO 2.5% Gel + Lymecycline|Gel applied once daily in the evening during 12 weeks Lymecycline 300mg taken once daily in the morning during 12 weeks
926053|NCT01014624|B3|Baseline|Total|Total of all reporting groups
926054|NCT01014624|B2|Baseline|Clopidogrel|Clopidogrel 75 mg tablet daily
926055|NCT01014624|B1|Baseline|Prasugrel|Prasugrel 10 mg tablet daily
926056|NCT01014624|P2|Participant Flow|Clopidogrel|Clopidogrel 75 mg daily
926057|NCT01014624|P1|Participant Flow|Prasugrel|Prasugrel 10 mg daily
926058|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
926059|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
926060|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
926061|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
926062|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
926063|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
926064|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
926065|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
926066|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
926067|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
926068|NCT01014624|O2|Outcome|Clopidogrel|Clopidogrel 75 mg tablet daily
926069|NCT01014624|O1|Outcome|Prasugrel|Prasugrel 10 mg tablet daily
926070|NCT01014624|O2|Outcome|Clopidogrel 75mg Daily|
926071|NCT01014624|O1|Outcome|Prasugrel 10mg Daily|
926072|NCT01014624|O2|Outcome|Clopidogrel 75 mg Daily|
926073|NCT01014624|O1|Outcome|Prasugrel 10 mg Daily|
926074|NCT01014624|E2|Reported Event|Clopidogrel 75mg/ Daily|
926075|NCT01014624|E1|Reported Event|Prasugrel 10 mg/Daily|
926076|NCT01014585|B5|Baseline|Total|Total of all reporting groups
926077|NCT01014585|B4|Baseline|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double-blind investigational product and therefore was not included in the Safety population."
926078|NCT01014585|B3|Baseline|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
926079|NCT01014585|B2|Baseline|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
926080|NCT01014585|B1|Baseline|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
926081|NCT01014585|P4|Participant Flow|Non-Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Non-Responders
926082|NCT01014585|P3|Participant Flow|Non-Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Non-Responders
926083|NCT01014585|P2|Participant Flow|Responders: Milnacipran (Milnacipran Continued)|The Randomized Population for Responders
926084|NCT01014585|P1|Participant Flow|Responders: Placebo (Milnacipran Withdrawn)|The Randomized Population for Responders
926085|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
926086|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
926087|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
926088|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
926089|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
926090|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
926091|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
926092|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
926093|NCT01014585|O4|Outcome|Non-Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Non-Responders: milnacipran treatment assignment, 50-200 mg per day, administered orally twice per day.
926094|NCT01014585|O3|Outcome|Non-Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Non-Responders: placebo treatment assignment, matching placebo, administered orally twice per day.
926095|NCT01014585|O2|Outcome|Responders: Milnacipran (Milnacipran Continued)|Intent to Treat (ITT) Population for Responders: milnacipran treatment assignment, milnacipran 50-200 mg per day, administered orally twice per day.
926096|NCT01014585|O1|Outcome|Responders: Placebo (Milnacipran Withdrawn)|Intent to Treat (ITT) Population for Responders: placebo treatment assignment, matching placebo administered orally twice per day.
926097|NCT01014585|E4|Reported Event|Non-Responders: Milnacipran (Milnacipran Continued)|"Safety Population for Non-Responders: milnacipran treatment assignment~One patient in the randomized population for non-responders assigned to milnacipran did not take at least one dose of double blind investigational product and therefore was not included in the Safety population."
926098|NCT01014585|E3|Reported Event|Non-Responders: Placebo (Milnacipran Withdrawn)|Safety Population for Non-Responders: placebo treatment assignment
926099|NCT01014585|E2|Reported Event|Responders: Milnacipran (Milnacipran Continued)|Safety Population for Responders: milnacipran treatment assignment
926271|NCT01014169|E2|Reported Event|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
926100|NCT01014585|E1|Reported Event|Responders: Placebo (Milnacipran Withdrawn)|"Safety Population for Responders: placebo treatment assignment~One patient in the randomized population for responders assigned to placebo did not take at least one dose of double blind investigational product and therefore was not included in the Safety Population."
926101|NCT01014455|B3|Baseline|Total|Total of all reporting groups
926102|NCT01014455|B2|Baseline|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
926103|NCT01014455|B1|Baseline|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
926104|NCT01014455|P2|Participant Flow|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
926105|NCT01014455|P1|Participant Flow|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
926106|NCT01014455|O2|Outcome|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
926107|NCT01014455|O1|Outcome|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
926108|NCT01014455|E2|Reported Event|no CO Reminder|a brief intervention that recommends fasting but does not mention that CO will be checked
926109|NCT01014455|E1|Reported Event|CO Reminder|A brief intervention that recommends preoperative fasting from cigarettes and that informs patients that their smoking status will be checked before surgery using inhaled CO monitoring will decrease their exposure to cigarette smoke prior to surgery
926110|NCT01014442|B3|Baseline|Total|Total of all reporting groups
926111|NCT01014442|B2|Baseline|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926112|NCT01014442|B1|Baseline|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926113|NCT01014442|P2|Participant Flow|MMF - COPD, Emphysema, IPF, or A1AD|Participants with chronic obstructive pulmonary disorder (COPD), emphysema, idiopathic pulmonary fibrosis (IPF), or alpha-1 antitrypsin deficiency (A1AD) having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926114|NCT01014442|P1|Participant Flow|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received mycophenolate mofetil (MMF) capsules at dose of 1.5 grams (g) twice daily (BID) from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926115|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
926116|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926117|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
926118|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926119|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
926449|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
931977|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
926120|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926121|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
926122|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926123|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
926124|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926125|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926126|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926127|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926128|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926129|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926130|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926131|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926132|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926133|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926134|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926135|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926136|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926137|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926138|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926139|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926140|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926141|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926142|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926143|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926144|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926145|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926450|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
934161|NCT00995930|E2|Reported Event|Placebo|SQ monthly
926146|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926147|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926148|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926149|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926150|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926151|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926152|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926153|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926154|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
927317|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
926155|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926156|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926157|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926158|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926159|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926160|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926161|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926162|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926163|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926164|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926165|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926166|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926167|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926168|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926169|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926170|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926171|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926172|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926173|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926174|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926175|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926176|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926177|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926178|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926179|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926180|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
927318|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
926181|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926182|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926183|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926184|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926185|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926186|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926187|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926188|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926189|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926190|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926191|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926192|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926193|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926194|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926195|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926196|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926223|NCT01014442|E2|Reported Event|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 and then at 1 g BID from Day 31 to Day 90.
926197|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926198|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926199|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926200|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926201|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926202|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926203|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926204|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926205|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926206|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926207|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926208|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926209|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926210|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926211|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926212|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926213|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926214|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926215|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926216|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926217|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, having transplantation at Day 0 received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926218|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926219|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926220|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926221|NCT01014442|O2|Outcome|MMF - COPD, Emphysema, IPF, or A1AD|Participants with COPD, emphysema, IPF or A1AD having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926222|NCT01014442|O1|Outcome|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926224|NCT01014442|E1|Reported Event|MMF - Cystic Fibrosis|Participants with cystic fibrosis having transplantation at Day 0, received MMF capsules at dose of 1.5 g BID from Day 2 to Day 30 post-transplantation and then at 1 g BID from Day 31 to Day 90 post-transplantation.
926225|NCT01014351|B1|Baseline|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
926226|NCT01014351|P1|Participant Flow|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
926227|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
926228|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
926229|NCT01014351|O1|Outcome|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
926275|NCT01014143|B2|Baseline|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
926230|NCT01014351|E1|Reported Event|Paclitaxel/Carboplatin/Everolimus|"Systemic Therapy using everolimus, paclitaxel and carboplatin given during a 21-day treatment cycle~Paclitaxel: Paclitaxel, 175mg/m2 by IV infusion over 1-3 hours on day 1 of every 21 day cycle~Carboplatin: Carboplatin, AUC 6 given by IV infusion over 20-30 minutes on day 1 of every 21 day cycle~Everolimus: Everolimus, 5 mg by mouth (PO) once a day, continuous dosing every 21-day cycle"
926231|NCT01014208|B3|Baseline|Total|Total of all reporting groups
926232|NCT01014208|B2|Baseline|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926233|NCT01014208|B1|Baseline|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926234|NCT01014208|P2|Participant Flow|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926235|NCT01014208|P1|Participant Flow|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926293|NCT01014091|P6|Participant Flow|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926451|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
934162|NCT00995930|E1|Reported Event|ACZ885 150mg|ACZ885 150mg
926236|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926237|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926238|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926272|NCT01014169|E1|Reported Event|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
926273|NCT01014143|B4|Baseline|Total|Total of all reporting groups
926239|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926240|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926241|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926242|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926294|NCT01014091|P5|Participant Flow|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926452|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
926453|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
926243|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926244|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926245|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926246|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926247|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926248|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926249|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926250|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926251|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926252|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926253|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926254|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926255|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926256|NCT01014208|O2|Outcome|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926257|NCT01014208|O1|Outcome|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926258|NCT01014208|E2|Reported Event|Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of ofatumumab combined with SC: either the DHAP regimen (three cycles of DHAP) or the DVD regimen (DHAP-VIM-DHAP). Ofatumumab (1000 mg/1000 milliliter [mL]) was infused IV on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the SC, and then on Day 1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/[m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hours every 12 hours (2 doses) for each infusion on Day 2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kg IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926259|NCT01014208|E1|Reported Event|Rituximab + Chemotherapy|Participants received 3 cycles (21 days per cycle) of rituximab combined with salvage chemotherapy (SC): either the DHAP regimen (3 cycles of dexamethasone, cytarabine, cisplatin [DHAP]) or the DVD regimen (DHAP-VIM [etoposide, ifosfamide, mesna, methotrexate]-DHAP). Rituximab (375 milligrams per meters squared [mg/m^2]) was infused intravenously (IV) on Day (D) 1 (or up to 3 days prior to D1) and D8 (+/-2 days) of Cycle 1 of the SC, and then on D1 only of Cycles 2 and 3. The DHAP regimen (SC) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on D1 of each cycle; and cytarabine 2 grams (g)/m^2 over 3 hours every 12 hours (2 doses) for each infusion on D2 of each cycle. VIM: etoposide (90 mg/m^2 IV on Days 1, 3, and 5), ifosfamide (1200 mg/m^2 IV on Days 1, 2, 3, 4, and 5), mesna (10 or 20 mg/kilogram [kg] IV on Days 1, 2, 3, 4, and 5), methotrexate (30 mg/m^2 IV on Days 1 and 5).
926260|NCT01014169|B3|Baseline|Total|Total of all reporting groups
926261|NCT01014169|B2|Baseline|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
926262|NCT01014169|B1|Baseline|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
926263|NCT01014169|P2|Participant Flow|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
926264|NCT01014169|P1|Participant Flow|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
926265|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
926266|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
926267|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
926268|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
926269|NCT01014169|O2|Outcome|Note Taking|The mothers in the intervention group were given a pen and paper and encouraged to take written notes using their language of preference when receiving the standard newborn information.
926270|NCT01014169|O1|Outcome|Usual Care|Mothers in the control group received newborn information from the nurse practitioner [sometimes via a Spanish interpreter, if required] according to current standard of care, which includes verbal information and written handouts.
926277|NCT01014143|P3|Participant Flow|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
926278|NCT01014143|P2|Participant Flow|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
926279|NCT01014143|P1|Participant Flow|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
926280|NCT01014143|O3|Outcome|Chlorhexidine Oral Rinse|chlorhexidine mouthrinse (positive control rinse)
926281|NCT01014143|O2|Outcome|Total Toothpaste|triclosan/fluoride toothpaste (positive control toothpaste)
926282|NCT01014143|O1|Outcome|Fluoride Toothpaste|negative control
926283|NCT01014143|E3|Reported Event|Chlorhexidine Oral Rinse First|chlorhexidine oral rinse first,1 week washout, fluoride toothpaste second, 1 week washout, triclosan/fluoride (Total)last
926284|NCT01014143|E2|Reported Event|Total Toothpaste First|triclosan/fluoride (Total)toothpaste first,1 week washout, Chlorhexidine rinse second, 1 week washout and fluoride toothpaste last
926285|NCT01014143|E1|Reported Event|Fluoride Toothpaste First|Fluoride first, 1 week washout,triclosan/fluoride (Total) second,1 week washout, Oral Rinse last
926286|NCT01014091|B7|Baseline|Total|Total of all reporting groups
926287|NCT01014091|B6|Baseline|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926288|NCT01014091|B5|Baseline|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926289|NCT01014091|B4|Baseline|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926290|NCT01014091|B3|Baseline|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926291|NCT01014091|B2|Baseline|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926292|NCT01014091|B1|Baseline|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926444|NCT01013844|P2|Participant Flow|Dyadic Learning|Participant and partner learning together.
926445|NCT01013844|P1|Participant Flow|Solo Learning|Participant learning alone (without partner).
926295|NCT01014091|P4|Participant Flow|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926296|NCT01014091|P3|Participant Flow|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926297|NCT01014091|P2|Participant Flow|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926298|NCT01014091|P1|Participant Flow|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926299|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926300|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926301|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926302|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926303|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926304|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
927319|NCT01011868|O1|Outcome|Placebo|Oral Placebo
926305|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926306|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926307|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926308|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926309|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926310|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926311|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926312|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926313|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926314|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926315|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926316|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926317|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926318|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926319|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926320|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926321|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926322|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926323|NCT01014091|O3|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926324|NCT01014091|O2|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926325|NCT01014091|O1|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926326|NCT01014091|O3|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926327|NCT01014091|O2|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926474|NCT01013792|E1|Reported Event|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
926328|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926329|NCT01014091|O6|Outcome|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926330|NCT01014091|O5|Outcome|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926331|NCT01014091|O4|Outcome|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926332|NCT01014091|O3|Outcome|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926333|NCT01014091|O2|Outcome|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926334|NCT01014091|O1|Outcome|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926335|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926336|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926337|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926338|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926339|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926340|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926446|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
926341|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926342|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926343|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926344|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926345|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926346|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926347|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926348|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926349|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926350|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926351|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926352|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926353|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926354|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926355|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926356|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926357|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926358|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926359|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926360|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926361|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926362|NCT01014091|O3|Outcome|GSK2340272A F3 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926363|NCT01014091|O2|Outcome|GSK2340272A F2 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926364|NCT01014091|O1|Outcome|GSK2340272A F1 Group|Healthy male or female children, between 3 and 9 years of age at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926447|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
926365|NCT01014091|E6|Reported Event|GSK2340272A F3 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926366|NCT01014091|E5|Reported Event|GSK2340272A F3 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 3 (F3) in the deltoid region of the arm, according to a 0-21 day schedule.
926367|NCT01014091|E4|Reported Event|GSK2340272A F2 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926368|NCT01014091|E3|Reported Event|GSK2340272A F2 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 2 (F2) in the deltoid region of the arm, according to a 0-21 day schedule.
926369|NCT01014091|E2|Reported Event|GSK2340272A F1 Y6-9 Group|Healthy male or female children, between 6 and 9 years of age (Y6-9) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926370|NCT01014091|E1|Reported Event|GSK2340272A F1 Y3-5 Group|Healthy male or female children, between 3 and 5 years of age (Y3-5) at the time of first study vaccination, who intramuscularly received 2 doses of GSK2340272A vaccine formulation 1 (F1) in the deltoid region of the arm, according to a 0-21 day schedule.
926371|NCT01014013|B3|Baseline|Total|Total of all reporting groups
926372|NCT01014013|B2|Baseline|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
926373|NCT01014013|B1|Baseline|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
926374|NCT01014013|P2|Participant Flow|Ceftriaxone|A single daily dose of 2.0 g Ceftriaxone sodium intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
926375|NCT01014013|P1|Participant Flow|MK0826|A single daily dose of MK0826 1.0 g intravenous infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin at a dose of 500 mg twice daily after 3 doses of parentheral therapy)
926429|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926376|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
926377|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
926378|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
926379|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
926380|NCT01014013|O2|Outcome|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up(5 to 9 days post-therapy) were considered as evaluable.(66 patients from MK0826 and 71 patients from Ceftriaxone). Those patients were considered as evaluable.
926381|NCT01014013|O1|Outcome|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who 1) received a proper course of therapy. 2) had a confirmed diagnosis of complicated urinary tract infection, including acute pyelonephritis, 3) had not comment an major protocol violations, and 4) were microbiologically evaluable at the early follow-up (5 to 9 days post-therapy). Those patients were considered as evaluable.
926382|NCT01014013|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium as a single daily dose of 2.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
926383|NCT01014013|E1|Reported Event|MK0826|MK0826 as a single daily dose of 1.0 g intravenous infusion and be switched to oral ciprofloxacin at a dose of 500 mg twice daily and patients who received at least 1 dose of parentheral therapy
926384|NCT01013961|B3|Baseline|Total|Total of all reporting groups
926385|NCT01013961|B2|Baseline|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
927259|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
926386|NCT01013961|B1|Baseline|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926387|NCT01013961|P2|Participant Flow|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926388|NCT01013961|P1|Participant Flow|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926389|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926390|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926430|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926391|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926392|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926393|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926394|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926395|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926396|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926448|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
926397|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926398|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926399|NCT01013961|O2|Outcome|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926400|NCT01013961|O1|Outcome|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926401|NCT01013961|E2|Reported Event|Arm B (Low Dose)|"Patients receive alemtuzumab SC on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and low-dose rituximab at 20 mg/m^2 IV on days 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC and low-dose rituximab IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926431|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926519|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926402|NCT01013961|E1|Reported Event|Arm A (Standard Dose)|"Patients receive alemtuzumab subcutaneously (SC) on days 1-3, 6, 8, 10, 13, 15, 17, 20, 22, 24, 27, 29, and 31 and standard-dose rituximab 375 mg/m^2/week intravenously (IV) on days 8, 15, 22, and 29 in cycle 1 (33-day cycle). In cycle 2 and subsequent cycles (28-day cycle), patients receive alemtuzumab SC on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26 and standard-dose rituximab IV on days 3, 10, 17, and 24. Treatment repeats every 28 days for up to 3 cycles.~Alemtuzumab dose for cycle 1 week 1 requires a 'dose ramp' (3 mg day 1, 10 mg day2, and 30 mg day 3 of cycle 1) and then is 30 mg 3 times a week."
926403|NCT01013883|B3|Baseline|Total|Total of all reporting groups
926404|NCT01013883|B2|Baseline|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
926405|NCT01013883|B1|Baseline|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
926406|NCT01013883|P2|Participant Flow|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
926407|NCT01013883|P1|Participant Flow|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
926408|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
926409|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
926410|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
926411|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
926412|NCT01013883|O2|Outcome|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
926413|NCT01013883|O1|Outcome|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
926414|NCT01013883|E2|Reported Event|Distolic Heart Failure|patients with clinical heart failure and preserved LV systolic dysfunction
926415|NCT01013883|E1|Reported Event|Systolic Dysfunction|patients having left ventricular systolic dysfunction on echocardiography
926416|NCT01013870|B3|Baseline|Total|Total of all reporting groups
926417|NCT01013870|B2|Baseline|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926418|NCT01013870|B1|Baseline|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926419|NCT01013870|P2|Participant Flow|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926420|NCT01013870|P1|Participant Flow|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926421|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926422|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926423|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926424|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926425|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926426|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926427|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926428|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926473|NCT01013792|E2|Reported Event|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
926432|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926433|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926434|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926435|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926436|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926437|NCT01013870|O2|Outcome|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926438|NCT01013870|O1|Outcome|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926439|NCT01013870|E2|Reported Event|mTBI-placebo Group|1:1 randomization will be used to assign half of enrolled subjects to the placebo arm. These subjects will receive a daily dose of an inert preparation, visually indistinguishable from the active agent. They will take this preparation for 7 days, starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving atorvastatin.
926440|NCT01013870|E1|Reported Event|mTBI-atorvastatin Group|1:1 randomization will be used to assign half of enrolled subjects to the treatment arm. These subjects will receive a daily weight-based dose of atorvastatin 1mg/kg (up to 80 mg) for 7 days starting within 24 hours of mTBI, and their outcome will be compared with the group of subjects receiving a placebo.
926441|NCT01013844|B3|Baseline|Total|Total of all reporting groups
926442|NCT01013844|B2|Baseline|Dyadic Learning|Participant and partner learning together.
926443|NCT01013844|B1|Baseline|Solo Learning|Participant learning alone (without partner).
926454|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
926455|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
926456|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
926457|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
926458|NCT01013844|O6|Outcome|Dyadic Learning 4-Month Follow-up|Participant and partner learning together.
926459|NCT01013844|O5|Outcome|Solo Learning 4-Month Follow-up|Participant learning alone (without partner).
926460|NCT01013844|O4|Outcome|Dyadic Learning Immediate Follow-up|Participant and partner learning together.
926461|NCT01013844|O3|Outcome|Solo Learning Immediate Follow-up|Participant learning alone (without partner).
926462|NCT01013844|O2|Outcome|Dyadic Learning Baseline|Participant and partner learning together.
926463|NCT01013844|O1|Outcome|Solo Learning Baseline|Participant learning alone (without partner).
926464|NCT01013844|E2|Reported Event|Dyadic Learning|Participant and partner learning together.
926465|NCT01013844|E1|Reported Event|Solo Learning|Participant learning alone (without partner).
926466|NCT01013792|B3|Baseline|Total|Total of all reporting groups
926467|NCT01013792|B2|Baseline|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
926468|NCT01013792|B1|Baseline|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
926469|NCT01013792|P2|Participant Flow|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
926470|NCT01013792|P1|Participant Flow|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
926471|NCT01013792|O2|Outcome|Tegaderm Matrix Dressing With PHI Technology|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs, cations, citric acid)
926472|NCT01013792|O1|Outcome|Non-adherent Wound Dressing|Wound Dressing: Acetate mesh carrier with ointment (water, PEGs)
926475|NCT01013753|B1|Baseline|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
926476|NCT01013753|P1|Participant Flow|Study Total|This was a randomised, double-blind, double dummy, placebo- and active-controlled, 6 treatment, 4 period incomplete crossover trial. 198 patients were assigned randomly to one of 30 treatment sequences, each sequence comprising 4 out of the 6 treatments listed: one of four doses (20 microgram (mcg), 10 mcg, 5 mcg or 2 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo. The duration of each treatment period was 4 weeks with no washout periods between treatments.
926477|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926478|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926479|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926480|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926481|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926482|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926483|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926484|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926485|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926486|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926487|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926488|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926489|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926490|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926491|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926492|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926493|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926494|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926495|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926496|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926497|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926498|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926499|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926500|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926501|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926502|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926503|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926504|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926505|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926506|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926507|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926508|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926509|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926510|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926511|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926512|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926513|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926514|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926515|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926516|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926517|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926518|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926520|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926521|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926522|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926523|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926524|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926525|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926526|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926527|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926528|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926529|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926530|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926531|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926532|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926533|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926534|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926535|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926536|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926537|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926538|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926539|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926540|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926541|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926542|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926543|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926544|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926545|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926546|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926547|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926548|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926549|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926550|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926551|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926552|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926553|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926554|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926555|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926556|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926557|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926558|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926559|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926560|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926561|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926562|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926563|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926564|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926565|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926566|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926567|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926568|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926569|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926570|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926571|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926572|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926573|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926574|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926575|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926576|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926577|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926578|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926579|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926580|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926581|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926582|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926583|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926584|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926585|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926586|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926587|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926588|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926589|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926590|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926591|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926592|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926593|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926594|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926595|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926596|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926597|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926598|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926599|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926600|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926601|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926602|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926603|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926604|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926605|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926606|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926607|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926608|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926609|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926610|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926611|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926612|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926613|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926614|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926615|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926616|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926617|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926618|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926619|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926620|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926621|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926622|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926623|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926624|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926625|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926626|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926627|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926628|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926629|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926630|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926631|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926632|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926633|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926634|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926635|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926636|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926637|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926638|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926639|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926640|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926641|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926642|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926643|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926644|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926645|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926646|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926647|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926648|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926649|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926650|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926651|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926652|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
934410|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
926653|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926654|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926655|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926656|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926657|NCT01013753|O6|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926658|NCT01013753|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926659|NCT01013753|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926660|NCT01013753|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926661|NCT01013753|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926662|NCT01013753|O1|Outcome|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926663|NCT01013753|E6|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
926664|NCT01013753|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926665|NCT01013753|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926666|NCT01013753|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926667|NCT01013753|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (evening, equivalent placebo morning) delivered by the Respimat Inhaler.
926668|NCT01013753|E1|Reported Event|Placebo|Equivalent Placebo (morning and evening) delivered by the matching Inhaler (Respimat or Aerolizer).
926669|NCT01013740|B3|Baseline|Total|Total of all reporting groups
951247|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
926670|NCT01013740|B2|Baseline|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
926671|NCT01013740|B1|Baseline|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
926672|NCT01013740|P2|Participant Flow|Lapatinib + Vinorelbine in RP; Lapatinib + Capecitabine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle. After disease progression in the Randomized Phase (in which participants received lapatinib plus capecitabine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus vinorelbine), and continuing in a post-progression Cross-over Phase.
926673|NCT01013740|P1|Participant Flow|Lapatinib + Capecitabine in RP; Lapatinib + Vinorelbine in CP|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water. After disease progression in the Randomized Phase (in which participants received lapatinib plus vinorelbine), participants were given the option of crossing over to the alternative treatment arm (lapatinib plus capecitabine), and continuing in a post-progression Cross-over Phase.
926674|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926675|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926676|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926692|NCT01013740|E4|Reported Event|Crossover Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Crossover phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
926693|NCT01013740|E3|Reported Event|Crossover Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Crossover phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
926694|NCT01013740|E2|Reported Event|Randomized Phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2|Randomized phase Lapatinib 1250mg QD + Vinorelbine 20mg/m2
926677|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926678|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926679|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926680|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926681|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926682|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926898|NCT01012323|B1|Baseline|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
951248|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
926683|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926684|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926685|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926686|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926687|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926688|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926689|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
926690|NCT01013740|O2|Outcome|Lapatinib Plus Vinorelbine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received an intravenous (IV) infusion of vinorelbine 20 mg/m^2 over the course of 5 to 10 minutes on Days 1 and 8 of a 21-day treatment cycle.
926691|NCT01013740|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) continuously at approximately the same time every day, either 1 hour (or more) before food or 1 hour (or more) after food. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food with approximately 200 milliliters (mL) of water.
927260|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
926695|NCT01013740|E1|Reported Event|Randomized Phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2|Randomized phase Lapatinib 1250mg QD + Capecitabine 2000mg/m2
926696|NCT01013597|B1|Baseline|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926697|NCT01013597|P1|Participant Flow|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926698|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926699|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926700|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926701|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926702|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926703|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926704|NCT01013597|O1|Outcome|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926705|NCT01013597|E1|Reported Event|LBH589|LBH589: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.
926706|NCT01013207|B1|Baseline|All Participants|
926707|NCT01013207|P1|Participant Flow|All Participants|
926708|NCT01013207|O1|Outcome|All Participants|
926709|NCT01013207|O1|Outcome|All Participants|
926710|NCT01013207|E1|Reported Event|All Participants|
926711|NCT01013194|B3|Baseline|Total|Total of all reporting groups
926712|NCT01013194|B2|Baseline|Control Patients|Patients with end-stage chronic liver disease on standard therapy in waiting list for liver transplantation.
926713|NCT01013194|B1|Baseline|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells.
926714|NCT01013194|P2|Participant Flow|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
926715|NCT01013194|P1|Participant Flow|Treated Patients|"Cell source: Non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.~Infusion technique: Isolation and incannulation of the femoral artery.Splenic artery infusion under radiological guidance.~Cell infusion: between 5x10^8 and 10x10^8 cells. Number of sessions: up to 2."
926716|NCT01013194|O2|Outcome|Control Patients|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
926717|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells.
926718|NCT01013194|O2|Outcome|Control Group|Cirrhotic patients in waiting list for Liver Transplantation on standard therapy
926719|NCT01013194|O1|Outcome|Treated Patients|Cirrhotic patients in waiting list for Liver Transplantation treated with non-purified and non-selected fetal liver stem cells
926720|NCT01013194|O2|Outcome|Control Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation on standard therapy
926721|NCT01013194|O1|Outcome|Treated Patients|Patients with end-stage chronic liver disease in waiting list for Liver Transplantation treated with hFLCTx
926722|NCT01013194|E2|Reported Event|Control Group|Patients with end-stage chronic liver disease in waiting list for liver transplantation.
926723|NCT01013194|E1|Reported Event|Treated Patients|Patients with end-stage chronic liver disease in waiting list for liver transplantation treated with non-purified and non-selected fetal liver cells from fetuses aborted between the 16th and 26th week of gestation.
926724|NCT01012973|B3|Baseline|Total|Total of all reporting groups
926725|NCT01012973|B2|Baseline|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
926726|NCT01012973|B1|Baseline|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926727|NCT01012973|P2|Participant Flow|Sham Treatment First, Then Aflibercept Injection|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
926728|NCT01012973|P1|Participant Flow|Aflibercept Injection First, Then Aflibercept Injection|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926729|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
926730|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926731|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
927261|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
926732|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926733|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
926734|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926735|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
926736|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926737|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
926899|NCT01012323|P1|Participant Flow|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
927320|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
926738|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926739|NCT01012973|O2|Outcome|Sham Treatment|Participants received sham treatment administered every 4 weeks from Day 1 through Week 52. Follow-up phase: Participants on sham treatment, who switched to Intravitreal Aflibercept Injection (IAI), received a 2 mg dose of IAI at week 52 and depending on the study retreatment criteria at Week 60 and 68.
926740|NCT01012973|O1|Outcome|Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20, later as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Follow-up phase: Participants on IAI, who continued the study, received 2 mg dose of IAI depending on the study retreatment criteria at Week 60 and 68.
926741|NCT01012973|E6|Reported Event|Sham Treatment Then Aflibercept Injection (Until Week 68)|Participants on sham treatment switched to IAI, received a 2 mg dose of IAI at Week 52 and depending on the study retreatment criteria at Week 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
926742|NCT01012973|E5|Reported Event|Aflibercept Injection Continued (Until Week 68)|Participants on IAI who continued the study drug until Week 52, received 2 mg dose of IAI depending on the study retreatment criteria at Week 52, 60 and 68. Participants were observed starting from Week 52. Participants in the safety population that completed Week 52 were at risk.
926743|NCT01012973|E4|Reported Event|Sham Treatment (Until Week 48)|Participants who continued the study drug until Week 24 received sham treatment administered every 4 weeks from Week 24 to Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
926744|NCT01012973|E3|Reported Event|Aflibercept Injection (Until Week 48)|Participants who continued the study drug until Week 24 received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered as often as every 4 weeks depending on the study retreatment criteria from Week 24 through Week 48. Participants were observed from Week 24 until Week 52. Participants in the safety population that completed Week 24 were at risk.
926745|NCT01012973|E2|Reported Event|Sham Treatment (Until Week 20)|Participants received sham treatment administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
926746|NCT01012973|E1|Reported Event|Aflibercept Injection (Until Week 20)|Participants received a 2 mg dose of Intravitreal Aflibercept Injection (IAI) administered every 4 weeks from Day 1 through Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
926747|NCT01012947|B6|Baseline|Total|Total of all reporting groups
926748|NCT01012947|B5|Baseline|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
926749|NCT01012947|B4|Baseline|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
926750|NCT01012947|B3|Baseline|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
926751|NCT01012947|B2|Baseline|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
926752|NCT01012947|B1|Baseline|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
926946|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
926753|NCT01012947|P5|Participant Flow|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
926754|NCT01012947|P4|Participant Flow|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
926755|NCT01012947|P3|Participant Flow|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
926756|NCT01012947|P2|Participant Flow|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
926757|NCT01012947|P1|Participant Flow|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
926758|NCT01012947|O5|Outcome|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator-initiated visit counseling bimonthly. Participants in the group E received reward.
926759|NCT01012947|O4|Outcome|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator-initiated visit counseling bimonthly.
926760|NCT01012947|O3|Outcome|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
926761|NCT01012947|O2|Outcome|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
926762|NCT01012947|O1|Outcome|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
926763|NCT01012947|E5|Reported Event|Lifestyle Counseling E, Visit, Reward|Participants in the group E received health educator–initiated visit counseling bimonthly. Participants in the group E received reward.
926764|NCT01012947|E4|Reported Event|Lifestyle Counseling D, Visit, Bimonthly|Participants in the group D received health educator–initiated visit counseling bimonthly.
926765|NCT01012947|E3|Reported Event|Lifestyle Counseling C, Telephone, Monthly|Participants in the group C received monthly the same telephonic care management and educational materials as those in the group B.
926766|NCT01012947|E2|Reported Event|Lifestyle Counseling B, Telephone, Bimonthly|Participants in the group B received bimonthly telephonic care management based on manual. Manager received training on a brief advice process, consisting of assessing activity level using a simple self-assessment tool; providing advice to increase activity and select a long-term goal.
926767|NCT01012947|E1|Reported Event|Lifestyle Counseling A,Usual Care|Usual care participants received no additional services.
926768|NCT01012765|B1|Baseline|Safety Set|The safety set included all participants who received at least one dose of study medication during at least one study period.
926769|NCT01012765|P6|Participant Flow|Tiotropium - Indacaterol - Placebo|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926770|NCT01012765|P5|Participant Flow|Placebo - Tiotropium - Indacaterol|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926771|NCT01012765|P4|Participant Flow|Placebo - Indacaterol - Tiotropium|In treatment period 1, patients received placebo to indacaterol once daily; in treatment period 2, patients received indacaterol 150µg once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926772|NCT01012765|P3|Participant Flow|Indacaterol - Tiotropium - Placebo|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received tiotropium 18µg twice daily; in treatment period 3, patients received placebo to indacaterol once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926773|NCT01012765|P2|Participant Flow|Indacaterol - Placebo - Tiotropium|In treatment period 1, patients received indacaterol 150µg once daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received tiotropium 18µg twice daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926793|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926947|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
926774|NCT01012765|P1|Participant Flow|Tiotropium - Placebo - Indacaterol|In treatment period 1, patients received tiotropium 18µg twice daily; in treatment period 2, patients received placebo to indacaterol once daily; in treatment period 3, patients received indacaterol 150µg once daily. Patients received indacaterol and placebo by single-dose dry powder inhaler (SDDPI); tiotropium was delivered via a proprietary inhalation device. There was a washout period of 13 days between each period. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926775|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926776|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926777|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926778|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926779|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926780|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926781|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926900|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
927321|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
926782|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926783|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926784|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926785|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926786|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926787|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926788|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926789|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926790|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926791|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926792|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926939|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
926940|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
926794|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926795|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926796|NCT01012765|O3|Outcome|Tiotropium|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926797|NCT01012765|O2|Outcome|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926798|NCT01012765|O1|Outcome|Indacaterol|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926799|NCT01012765|E3|Reported Event|Tiotropium 18ug|Tiotropium 18µg once daily was administered via a proprietary inhalation device. Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926800|NCT01012765|E2|Reported Event|Placebo|Placebo to indacaterol was administered once daily by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926801|NCT01012765|E1|Reported Event|Indacaterol 150ug|Indacaterol 150µg once daily was administered by a single-dose dry powder inhaler (SDDPI). Use of fixed-dose combination of an anticholinergic plus a short-acting β2-agonist and use of long-acting β2-agonists were discontinued. Salbutamol rescue use was allowed during the treatment period as needed.
926813|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926802|NCT01012739|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg via the Concept1 dry-powder inhaler (DPI), indacaterol 60 µg via the Simoon DPI, indacaterol 120 µg via the Simoon DPI, and placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926803|NCT01012739|P4|Participant Flow|Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg|In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926804|NCT01012739|P3|Participant Flow|Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg|In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926805|NCT01012739|P2|Participant Flow|Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo|In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926806|NCT01012739|P1|Participant Flow|Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg|In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
934411|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
926807|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926808|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926809|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926810|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926811|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926812|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received Indacaterol 150 μg via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926851|NCT01012661|B1|Baseline|Radiesse® Mixed With Lidocaine and Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
926814|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926815|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926816|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926817|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926818|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926819|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926820|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926821|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926822|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926823|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926824|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926825|NCT01012739|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926826|NCT01012739|O3|Outcome|Indacaterol 120 μg|Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926827|NCT01012739|O2|Outcome|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926893|NCT01012388|E1|Reported Event|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
926894|NCT01012336|B1|Baseline|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
926828|NCT01012739|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926829|NCT01012739|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926830|NCT01012739|E3|Reported Event|Indacaterol 120 μg|Patients received indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926831|NCT01012739|E2|Reported Event|Indacaterol 60 μg|Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926832|NCT01012739|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI)only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
926833|NCT01012713|B1|Baseline|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
926834|NCT01012713|P1|Participant Flow|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in the Psoriasis Area and Severity Index thereafter."
926835|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than a 75% reduction in Psoriasis Area and Severity Index."
926941|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
927254|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
926836|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
926837|NCT01012713|O1|Outcome|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
926838|NCT01012713|E1|Reported Event|Open-Label Treatment|"All patients will receive treatment with Clobex Spray, Vectical Ointment, and Excimer Laser~Clobex Spray: Clobex Spray BID for Weeks 1-4 and weeks 9-12~Vectical Ointment: Vectical ointment BID for weeks 5-8 and 9-12~Excimer Laser: Laser treatment for weeks 1-6 study and as needed for patients with less than 75% reduction in Psoriasis Area and Severity Index thereafter."
926839|NCT01012674|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
926840|NCT01012674|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
926841|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
926842|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
926843|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
926844|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
926845|NCT01012674|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
926846|NCT01012674|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
926847|NCT01012674|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn from the study before Dotarem IV administration whatever the reason
926848|NCT01012674|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from CT angiography after the IV administration of an iodinated contrast medium
926849|NCT01012674|E2|Reported Event|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
926850|NCT01012674|E1|Reported Event|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
926895|NCT01012336|P1|Participant Flow|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
926852|NCT01012661|P1|Participant Flow|Radiesse® Mixed With Lidocaine & Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl) and Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl). The same 50 participants received both the treatment device and the control device at the same time (left and right sides of face).
926853|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
926854|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
926855|NCT01012661|O2|Outcome|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
926856|NCT01012661|O1|Outcome|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
926857|NCT01012661|E2|Reported Event|Radiesse® Without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier without 2% lidocaine hydrochloride (HCl)
926858|NCT01012661|E1|Reported Event|Radiesse® Mixed With Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier containing 2% lidocaine hydrochloride (HCl)
926859|NCT01012622|B1|Baseline|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926860|NCT01012622|P1|Participant Flow|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926861|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926862|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926942|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
934412|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
926863|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926864|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926865|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926866|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926867|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926868|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926869|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926896|NCT01012336|O1|Outcome|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist. Patients received the following regimen (Day 1: aprepitant 125 mg, ramosetron 0.6 mg, and dexamethasone 20 mg before chemotherapy; Days 2-3: aprepitant 80 mg every day)
927322|NCT01011868|O1|Outcome|Placebo|Oral Placebo
926870|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926871|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926872|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926873|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926874|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926875|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926876|NCT01012622|O1|Outcome|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926943|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
926877|NCT01012622|E1|Reported Event|Osmotic Release Oral System (OROS) Methylphenidate HCL|OROS methylphenidate hydrochloride (HCL) was given orally once daily at an initial dose of 18 milligram (mg) for participants below 30 Kilogram (kg) and 27 mg for those over 30 kg of body weight. The dose was increased by 9 mg or 18 mg every week for up to Week 8, followed by a maximum maintenance dose of 54 mg orally once daily up to Week 12 during which the dose can be decreased by 9 mg depending on tolerability.
926878|NCT01012440|B1|Baseline|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
926879|NCT01012440|P1|Participant Flow|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
926880|NCT01012440|O1|Outcome|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
926881|NCT01012440|E1|Reported Event|Beast Cancer Subjects|"Subject will have assessment of neoadjuvant chemotherapy treatment response by both MRI and PEM to compare methods~PEM Flex Solo II PET Scanner: Subjects will receive bilateral (both sides) breast and axillary PEM scans.~MRI scan: Subjects will receive bilateral (both sides) breast and axillary MRI scans."
926882|NCT01012414|B1|Baseline|Enrolled|Total number participants consentedand enrolled
926883|NCT01012414|P1|Participant Flow|All Participants|The participants could have been randomized to one of the 2 arms; study drug or placebo. The study was never unblinded before termination.
926884|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
926885|NCT01012414|O1|Outcome|All Participants|No arm/group title is provided
926886|NCT01012414|O1|Outcome|Alll Participants|no arm /group title is provided as there was no enrollment.
926887|NCT01012414|O1|Outcome|All Participants|no arm /group title is provided as there was no enrollment.
926888|NCT01012414|E1|Reported Event|All Participants|All participants in the study.
926889|NCT01012388|B1|Baseline|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
926890|NCT01012388|P1|Participant Flow|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
926891|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
926892|NCT01012388|O1|Outcome|Radiesse Injectable Dermal Filler|Injectable Dermal Filler - Calcium hydroxylapatite particles suspected in an aqueous based gel carrier for subcutaneous injection for the treatment of nasolabial folds
926897|NCT01012336|E1|Reported Event|Aprepitant|Aprepitant is a selective, high-affinity NK1 receptor antagonist
926901|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926902|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926903|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926904|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926905|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926906|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926907|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926908|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926909|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926910|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926911|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926912|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926913|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926914|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926915|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926916|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926917|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926918|NCT01012323|O1|Outcome|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926919|NCT01012323|E1|Reported Event|NewGam|Participants received NewGam 200-800 mg/kg intravenously every 3 weeks (17 infusions) or 4 weeks (13 infusions) for 1 year.
926944|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926945|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926920|NCT01012258|B1|Baseline|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
926921|NCT01012258|P1|Participant Flow|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
926922|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
926923|NCT01012258|O1|Outcome|Cetuximab|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy (RT): 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval.
926924|NCT01012258|E2|Reported Event|Cetuximab: Late Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Late phase, i.e. adverse events which occur or worsen more than 60 days after the last trial treatment administration (cetuximab or radiotherapy), and before end of trial.
926967|NCT01012219|B1|Baseline|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
927019|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926925|NCT01012258|E1|Reported Event|Cetuximab: Treatment Emergent Phase|Participants received cetuximab 400 milligram/square meter (mg/m^2) intravenous (IV) infusion over 120 minutes for 1 week, subsequently followed by 250 mg/m^2 IV infusion over 60 minutes, from week 2 to 7 along with concomitant boost radiotherapy: 72.0 Gray (Gy) total for 42 fractions in 6 weeks, initially, once-daily fractions: 32.4 Gy in 18 fractions of 1.8 Gy for 3.6 weeks (5 fractions/week), followed by twice-daily fractions 39.6 Gy in 24 fractions for 2.4 weeks: morning dose 1.8 Gy/fraction for a total of 12 fractions 5 fractions/week; evening dose 1.5 Gy/fraction for a total of 12 fractions 5 fractions/week. Doses were separated by at least a 6-hour interval. Treatment emergent phase, i.e. treatment-emergent adverse events (TEAEs, adverse events which occur or worsen on the first dosing day of trial treatment and until 60 days after the last trial treatment administration (cetuximab or radiotherapy).
926926|NCT01012245|B5|Baseline|Total|Total of all reporting groups
926927|NCT01012245|B4|Baseline|Other Medication|Subjects with other or no hypotensive therapy at baseline visit
926928|NCT01012245|B3|Baseline|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
926929|NCT01012245|B2|Baseline|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit
926930|NCT01012245|B1|Baseline|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926931|NCT01012245|P1|Participant Flow|Subjects With Glaucoma and Ocular Hypertension|All subjects group: documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups: Xalatan®: subjects with Xalatan® (latanoprost) monotherapy at baseline visit; Betablockers: subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit; Xalacom®: subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit; other medications: subjects with other or no hypotensive therapy at baseline visit.
926932|NCT01012245|O2|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
926933|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926934|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
926935|NCT01012245|O1|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926936|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
926937|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
926938|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension and a documented glaucoma medication at baseline visit.
934413|NCT00995345|O1|Outcome|Placebo|Tablet
926948|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
926949|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926950|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
926951|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
926952|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
926953|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
926954|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926955|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
926956|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
926957|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
926958|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
926959|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926960|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
926961|NCT01012245|O5|Outcome|Other Medications|Subjects with other or no hypotensive therapy at baseline visit.
926962|NCT01012245|O4|Outcome|Xalacom®|Subjects with Xalacom® (latanoprost + timolol maleate) therapy at baseline visit
926963|NCT01012245|O3|Outcome|Betablockers|Subjects with only 1 betablocker and subjects with more than one betablocker at baseline visit.
926964|NCT01012245|O2|Outcome|Xalatan®|Subjects with Xalatan® (latanoprost) monotherapy at baseline visit
926965|NCT01012245|O1|Outcome|All Subjects|Documented diagnosis of glaucoma or ocular hypertension at baseline visit; includes subjects from the 4 treatment groups.
926966|NCT01012245|E1|Reported Event|All Subjects|Subjects with documented diagnosis of glaucoma or ocular hypertension at baseline visit.
927018|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927302|NCT01011868|B3|Baseline|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
926968|NCT01012219|P1|Participant Flow|All Participants|Periods 1 and 2 evaluated the effects of multiple doses of laropiprant on the antiplatelet effects of clopidogrel and aspirin administered in combination in participants with primary hypercholesterolemia or mixed dyslipidemia. Period 3 was open-label and evaluated single dose pharmacokinetics of nicotinic acid and laropiprant components of Tredaptive.
926969|NCT01012219|O2|Outcome|Clopidogrel + Aspirin|Participants from Periods 1 and 2
926970|NCT01012219|O1|Outcome|Clopidogrel + Aspirin +Laropiprant|Participants from Periods 1 and 2
926971|NCT01012219|E3|Reported Event|Laropiprant + Niacin|Participants from Period 3
926972|NCT01012219|E2|Reported Event|Clopidogrel + Aspirin|Participants from Periods 1 and 2
926973|NCT01012219|E1|Reported Event|Laropiprant + Clopidrogel + Aspirin|Participants from Periods 1 and 2
926974|NCT01012167|B4|Baseline|Total|Total of all reporting groups
926975|NCT01012167|B3|Baseline|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
926976|NCT01012167|B2|Baseline|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
926977|NCT01012167|B1|Baseline|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
926978|NCT01012167|P3|Participant Flow|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
926979|NCT01012167|P2|Participant Flow|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
926980|NCT01012167|P1|Participant Flow|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926981|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
926982|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
926983|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926984|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
926985|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
926986|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926987|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
926988|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
926989|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926990|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
926991|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
926992|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926993|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
926994|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
926995|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926996|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
934425|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
926997|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
926998|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
926999|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927000|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927001|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927002|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927003|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927004|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927005|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927006|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927007|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927008|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927009|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927010|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927011|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927012|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927013|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927014|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927015|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927016|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927017|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927303|NCT01011868|B2|Baseline|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927020|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927021|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927022|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927023|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927024|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927025|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927026|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927027|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927028|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927029|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927030|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927031|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927032|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927033|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927034|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927035|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927036|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927037|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927038|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927039|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927040|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927041|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927042|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927043|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927044|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927045|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927046|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927047|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927048|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927049|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927050|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927051|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927052|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927053|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927054|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927055|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927056|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927057|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927058|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927059|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927060|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927061|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927062|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927063|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927064|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927065|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927066|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927067|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927068|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927069|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927070|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927071|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927072|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927073|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927074|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927075|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927076|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927077|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927078|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927079|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927080|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927081|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927082|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927083|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927084|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927085|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927086|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927087|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927088|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927089|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927090|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927091|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927092|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927093|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927094|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927095|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927096|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927097|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927098|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927099|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927100|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927101|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927102|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927103|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927104|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927105|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927106|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927107|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927108|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927109|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927110|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927111|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927112|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927113|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927114|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927115|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927116|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927117|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927118|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927119|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927120|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927121|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927122|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927123|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927124|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927125|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927126|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927127|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927128|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927129|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927130|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927131|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927132|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927133|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927134|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927135|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927136|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927137|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927138|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927139|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927140|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927141|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927142|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927143|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927144|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927145|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927146|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927147|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927148|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927149|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927150|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927151|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927152|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927153|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927154|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927155|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927156|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927157|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927158|NCT01012167|O3|Outcome|3: Placebo|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927159|NCT01012167|O2|Outcome|2: Galantamine|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927160|NCT01012167|O1|Outcome|1: Oxytocin|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927161|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927162|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927163|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927164|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927165|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927166|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927167|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927168|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927169|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927170|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin.
927171|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927172|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927173|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927174|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927175|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927304|NCT01011868|B1|Baseline|Placebo|Oral Placebo
927176|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927177|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927178|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927179|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927180|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927181|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927182|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927183|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927184|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927185|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927186|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927187|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927188|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927189|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927190|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927191|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927192|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927193|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927194|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927195|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927196|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927197|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927198|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927199|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927200|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927201|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927202|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927203|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927204|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927205|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927206|NCT01012167|O3|Outcome|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
927207|NCT01012167|O2|Outcome|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
927208|NCT01012167|O1|Outcome|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
927209|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927210|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927211|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927212|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927213|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927214|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927215|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927216|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927217|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927218|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927219|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927220|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927305|NCT01011868|P3|Participant Flow|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
927221|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927222|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927223|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927224|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927225|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927226|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927227|NCT01012167|O3|Outcome|3: Placebo-galantamine /Placebo-oxytocin|Subjects randomized to placebo will receive placebo-galantamine and placebo-oxytocin
927228|NCT01012167|O2|Outcome|2: Galantamine/Placebo-oxytocin|Subjects randomized to galantamine will receive galantamine and placebo-oxytocin
927229|NCT01012167|O1|Outcome|1: Oxytocin/Placebo-galantamine|Subjects randomized to oxytocin will receive oxytocin and placebo-galantamine
927230|NCT01012167|E3|Reported Event|3: Placebo|Placebo: placebo-Galantamine 1 capsules twice a day and placebo-oxytocin 3 puffs in each nostril once a day.
927231|NCT01012167|E2|Reported Event|2: Galantamine|Galantamine or placebo Galantamine: Galantamine will be dispensed as follows: 4 mg bid x 7 days; 8mg bid x 7days, then 12 mg bid for the last 4 weeks.
927232|NCT01012167|E1|Reported Event|1: Oxytocin|Oxytocin: 24 IU oxytocin or placebo in a total of 6 puffs (3 puffs per nostril)daily for 6 weeks
927233|NCT01012037|B4|Baseline|Total|Total of all reporting groups
927234|NCT01012037|B3|Baseline|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927235|NCT01012037|B2|Baseline|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927236|NCT01012037|B1|Baseline|Placebo|Patients treated with matching placebo
927237|NCT01012037|P3|Participant Flow|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927238|NCT01012037|P2|Participant Flow|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927239|NCT01012037|P1|Participant Flow|Placebo|Patients treated with matching placebo
927240|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927241|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927242|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
927243|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927244|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927245|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
927246|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927247|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927248|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
927249|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927250|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927251|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
927252|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927253|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927262|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927263|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
927264|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927265|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927266|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
927267|NCT01012037|O3|Outcome|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927268|NCT01012037|O2|Outcome|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927269|NCT01012037|O1|Outcome|Placebo|Patients treated with matching placebo
927270|NCT01012037|E3|Reported Event|Lina 5 Once Daily (qd)|Patients treated with Linagliptin 5mg qd
927271|NCT01012037|E2|Reported Event|Lina 2.5 Twice Daily (Bid)|Patients treated with Linagliptin 2.5mg bid
927272|NCT01012037|E1|Reported Event|Placebo|Patients treated with matching placebo
927273|NCT01011946|B1|Baseline|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
927274|NCT01011946|P1|Participant Flow|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
927306|NCT01011868|P2|Participant Flow|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927275|NCT01011946|O1|Outcome|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
927276|NCT01011946|E1|Reported Event|Positron Emission Mammography|Positron Emission Mammography: Patients will receive bilateral (both sides) breast and axillary PEM scans, bilateral mammography, DCE-MRI, US of the breast and axilla (the side of the affected breast), and ultrasound guided biopsy of axillary lymph node if suspicious. Various PEM views will be performed on both your breast and axilla (underarm).
927277|NCT01011933|B1|Baseline|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
927278|NCT01011933|P1|Participant Flow|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
927279|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
927280|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
927281|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
927282|NCT01011933|O1|Outcome|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
927283|NCT01011933|E1|Reported Event|Treatment (Selumetinib)|Patients receive selumetinib PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Blood and archived tumor tissue samples are collected for biomarker studies.
927284|NCT01011907|B3|Baseline|Total|Total of all reporting groups
927285|NCT01011907|B2|Baseline|Varenicline|
927286|NCT01011907|B1|Baseline|Placebo|
927287|NCT01011907|P2|Participant Flow|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
927288|NCT01011907|P1|Participant Flow|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
927289|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
927290|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
927291|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
927292|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
927359|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
927533|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
927293|NCT01011907|O2|Outcome|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
927294|NCT01011907|O1|Outcome|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
927295|NCT01011907|E2|Reported Event|Varenicline|"Drug: varenicline (Chantix) 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84).~varenicline : 12 weeks of oral tablet treatment in an escalating dosing regimen (0.5 mg 1x daily, days 1-3; 0.5mg 2x daily, days 4-7, 1.0 mg 2x daily, days 8-84)."
927296|NCT01011907|E1|Reported Event|Placebo|"Drug: placebo for varenicline 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily).~placebo : 12 weeks of oral tablet treatment in an escalating dosing regimen (1 - 2x daily)."
927297|NCT01011894|B1|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
927298|NCT01011894|P1|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
927299|NCT01011894|O1|Outcome|Participants Receiving Lenalidomide|Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.
927300|NCT01011894|E1|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open label study designed to assess the efficacy of continuous lenalidomide therapy in patient >/= 65 years old.
927301|NCT01011868|B4|Baseline|Total|Total of all reporting groups
927307|NCT01011868|P1|Participant Flow|Placebo|Oral Placebo
927323|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
927324|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927325|NCT01011868|O1|Outcome|Placebo|Oral Placebo
927326|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
927327|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927328|NCT01011868|O1|Outcome|Placebo|Oral Placebo
927329|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
927330|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927331|NCT01011868|O1|Outcome|Placebo|Oral Placebo
927332|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
927333|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927334|NCT01011868|O1|Outcome|Placebo|Oral Placebo
927335|NCT01011868|O3|Outcome|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
927336|NCT01011868|O2|Outcome|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927337|NCT01011868|O1|Outcome|Placebo|Oral Placebo
927338|NCT01011868|E3|Reported Event|Empagliflozin 25 mg|Empagliflozin 25 mg orally once daily
927339|NCT01011868|E2|Reported Event|Empagliflozin 10 mg|Empagliflozin 10 mg orally once daily
927340|NCT01011868|E1|Reported Event|Placebo|Oral Placebo
927341|NCT01011829|B3|Baseline|Total|Total of all reporting groups
927342|NCT01011829|B2|Baseline|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
927343|NCT01011829|B1|Baseline|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
927344|NCT01011829|P2|Participant Flow|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
927345|NCT01011829|P1|Participant Flow|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
927346|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
927347|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
927348|NCT01011829|O2|Outcome|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
927349|NCT01011829|O1|Outcome|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
927350|NCT01011829|E2|Reported Event|Placebo (Sugar Pill)|8 weeks of daily matching oral placebo in tablet form
927351|NCT01011829|E1|Reported Event|Varenicline|Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 8).
927352|NCT01011816|B3|Baseline|Total|Total of all reporting groups
927353|NCT01011816|B2|Baseline|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
927354|NCT01011816|B1|Baseline|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
927355|NCT01011816|P2|Participant Flow|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
927356|NCT01011816|P1|Participant Flow|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
927357|NCT01011816|O2|Outcome|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
927358|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
927424|NCT01011634|O2|Outcome|Oral Medication|
927360|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
927361|NCT01011816|O2|Outcome|Saline|"One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc~Saline: One injection of up to 4 mL of saline using the Biostat Delivery Device"
927362|NCT01011816|O1|Outcome|BIOSTAT BIOLOGX|"One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc~BIOSTAT BIOLOGX: One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device"
927363|NCT01011816|E2|Reported Event|Saline|One injection of up to 4 mL of saline solution into a single lumbar intervertebral disc using the Biostat Delivery Device
927364|NCT01011816|E1|Reported Event|BIOSTAT BIOLOGX|One injection of up to 4 mL of BIOSTAT BIOLOGX Fibrin Sealant into a single lumbar intervertebral disc using the Biostat Delivery Device
927365|NCT01011738|B4|Baseline|Total|Total of all reporting groups
927366|NCT01011738|B3|Baseline|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
927367|NCT01011738|B2|Baseline|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927368|NCT01011738|B1|Baseline|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927369|NCT01011738|P3|Participant Flow|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
927370|NCT01011738|P2|Participant Flow|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927371|NCT01011738|P1|Participant Flow|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927372|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
927373|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927374|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927375|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
927376|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927377|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927378|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
927379|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927380|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927381|NCT01011738|O3|Outcome|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
927425|NCT01011634|O1|Outcome|Moderate Sedation|
927426|NCT01011634|O2|Outcome|Oral Medication|
927427|NCT01011634|O1|Outcome|Moderate Sedation|
927382|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927383|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927384|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927385|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927386|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927387|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927388|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927389|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927390|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927391|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927392|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927393|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927394|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927395|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927428|NCT01011634|E2|Reported Event|IV Medications|
927429|NCT01011634|E1|Reported Event|Oral Medications|
927430|NCT01011556|B5|Baseline|Total|Total of all reporting groups
927431|NCT01011556|B4|Baseline|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927396|NCT01011738|O1|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927397|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927398|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927399|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927400|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927401|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927444|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927402|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927403|NCT01011738|O2|Outcome|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927404|NCT01011738|O1|Outcome|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927405|NCT01011738|E3|Reported Event|HBeAg Status Unknown|This group included participants with Chronic Hepatitis B (CHB) virus infection whose HBeAg status was not known.
927406|NCT01011738|E2|Reported Event|HBeAg Negative|This group included participants who tested negative for Hepatitis B envelope antigen (HBeAg) when entering the study. HBeAg-negative Hepatitis B is a form of the virus that does not cause infected cells to secrete HBeAg. Participant can be infected with the HBeAg-negative form of the virus from the beginning, or the viral mutation can emerge later in the course of infection in participant initially infected with the HBeAg-positive form of the virus. HBeAg-negative chronic hepatitis is thus characterized by detection of HBsAg without HBeAg in serum.
927407|NCT01011738|E1|Reported Event|HBeAg Positive|This group included participants who tested positive for Hepatitis B envelope antigen (HBeAg) when entering the study. Hepatitis B envelope antigen is a protein from the Hepatitis B virus that circulates in infected blood when the virus is actively replicating. The presence of HBeAg suggests that the participant is infectious and is able to spread the virus to other people.
927408|NCT01011673|B3|Baseline|Total|Total of all reporting groups
927409|NCT01011673|B2|Baseline|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
927410|NCT01011673|B1|Baseline|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
927411|NCT01011673|P2|Participant Flow|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
927412|NCT01011673|P1|Participant Flow|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
927413|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
927414|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
927415|NCT01011673|O2|Outcome|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
927416|NCT01011673|O1|Outcome|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
927417|NCT01011673|E2|Reported Event|Metoclopramide|metoclopramide 20 mg + diphenhydramine 25 mg, administered intravenously over 15 minutes
927418|NCT01011673|E1|Reported Event|Ketorolac|Ketorolac 30 mg, administered intravenously over 15 minutes
927419|NCT01011634|B3|Baseline|Total|Total of all reporting groups
927420|NCT01011634|B2|Baseline|Oral Medication|
927421|NCT01011634|B1|Baseline|Moderate Sedation|
927422|NCT01011634|P2|Participant Flow|Oral Medication|
927423|NCT01011634|P1|Participant Flow|Moderate Sedation|
927432|NCT01011556|B3|Baseline|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927433|NCT01011556|B2|Baseline|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927434|NCT01011556|B1|Baseline|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927435|NCT01011556|P4|Participant Flow|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927436|NCT01011556|P3|Participant Flow|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927437|NCT01011556|P2|Participant Flow|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927438|NCT01011556|P1|Participant Flow|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927439|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927440|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927441|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927442|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927443|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927445|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927446|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927447|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927448|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927449|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927450|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927451|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927452|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927453|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927454|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927455|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927456|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927457|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927458|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927459|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927460|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927461|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927462|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 mcg teriparatide subcutaneously once daily in an unblinded manner.
927463|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927464|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927465|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927466|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927467|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927468|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927469|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927470|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927471|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927472|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927473|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927474|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927475|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927476|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927477|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927478|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927479|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927480|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927481|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927482|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
927483|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927484|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
951249|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
927485|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level
927486|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
927487|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927488|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927489|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927490|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
927491|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927492|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927493|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927494|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927495|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927496|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927497|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927498|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927499|NCT01011556|O4|Outcome|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927500|NCT01011556|O3|Outcome|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927501|NCT01011556|O2|Outcome|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927502|NCT01011556|O1|Outcome|20 Mcg Subcutaneous Teriparatide|Received 20 micrograms (mcg) teriparatide subcutaneously once daily in an unblinded manner.
927503|NCT01011556|E4|Reported Event|80 Mcg Transdermal Teriparatide|Received 80 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927504|NCT01011556|E3|Reported Event|50 Mcg Transdermal Teriparatide|Received 50 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927505|NCT01011556|E2|Reported Event|30 Mcg Transdermal Teriparatide|Received 30 mcg teriparatide transdermally via a patch applied once daily. Participants were blinded to dose level.
927506|NCT01011556|E1|Reported Event|20 Mcg Subcutaneous Teriparatide|Received 20 microgram (mcg) teriparatide subcutaneously (injected) once daily in an unblinded manner.
927507|NCT01011465|B9|Baseline|Total|Total of all reporting groups
927508|NCT01011465|B8|Baseline|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927713|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927509|NCT01011465|B7|Baseline|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927510|NCT01011465|B6|Baseline|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927511|NCT01011465|B5|Baseline|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927555|NCT01011309|B3|Baseline|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
927658|NCT01010971|P1|Participant Flow|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927512|NCT01011465|B4|Baseline|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927513|NCT01011465|B3|Baseline|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927514|NCT01011465|B2|Baseline|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927515|NCT01011465|B1|Baseline|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927516|NCT01011465|P8|Participant Flow|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927517|NCT01011465|P7|Participant Flow|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927531|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
927518|NCT01011465|P6|Participant Flow|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927519|NCT01011465|P5|Participant Flow|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927520|NCT01011465|P4|Participant Flow|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927556|NCT01011309|B2|Baseline|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
927557|NCT01011309|B1|Baseline|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
927521|NCT01011465|P3|Participant Flow|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927522|NCT01011465|P2|Participant Flow|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927523|NCT01011465|P1|Participant Flow|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927524|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
927525|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
927526|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
927527|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
927528|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
927529|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
927530|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
927532|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
927534|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
927535|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
927536|NCT01011465|O6|Outcome|Social Support - Friend|Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals.
927537|NCT01011465|O5|Outcome|Social Support - Alone|Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks.
927538|NCT01011465|O4|Outcome|Male|Effects of stress exposure examined among men versus women
927539|NCT01011465|O3|Outcome|Female|Effects of stress exposure examined among women versus men
927540|NCT01011465|O2|Outcome|Placebo Group|Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.
927558|NCT01011309|P3|Participant Flow|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
927659|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927541|NCT01011465|O1|Outcome|Oxytocin Group|Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.
927542|NCT01011465|E8|Reported Event|Male, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927543|NCT01011465|E7|Reported Event|Male, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927544|NCT01011465|E6|Reported Event|Male, OT, Friend|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927545|NCT01011465|E5|Reported Event|Male, OT, Alone|"Effects of intranasal oxytocin and social support examined among men versus women.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927546|NCT01011465|E4|Reported Event|Female, Placebo, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927547|NCT01011465|E3|Reported Event|Female, Placebo, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Placebo : Participants in the placebo condition receive an equivalent amount of saline for intranasal spray administration. The placebo is administered at one time only during the procedure. Approximately half the dose is sprayed into each nostril. Administration stops after the full amount in the spray bottle has been used.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927548|NCT01011465|E2|Reported Event|Female, OT, Friend|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Friend : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. If instructed to bring a same-sex close friend (excluding spouses), participants are joined by their support partners at the start of the stress exposure. The social support condition includes a number of strategies designed to standardize the type of support available to participants across individuals."
927549|NCT01011465|E1|Reported Event|Female, OT, Alone|"Effects of intranasal oxytocin and social support examined among women versus men.~Intranasal oxytocin : The aqueous form of oxytocin (oxytocin injection, synthetic) in 10 ml vials is inserted into a spray bottle. The spray bottle is calibrated so that emptying the spray bottle results in delivering 24 IU of oxytocin. No dilution of the original aqueous form of the oxytocin is necessary. 24 IU of oxytocin is administered.~Social support - Alone : Prior to lab visit, participant is randomly assigned to one of two conditions, requiring them to appear alone or accompanied by partner. Participant assigned to alone is unaccompanied during tasks."
927550|NCT01011387|B1|Baseline|NPWT System|Negative Pressure Wound Therapy
927551|NCT01011387|P1|Participant Flow|Negative Pressure Wound Therapy System|The Avance NPWT system is intended to help promote wound healing, including drainage and removal of infectious material or other fluids, under the influence of continuous and/or intermittent negative pressure. Avance NPWT system is designed to be used for a wide range of wounds which are suitable for NPWT.
927552|NCT01011387|O1|Outcome|NPWT System|Negative Pressure Wound Therapy
927553|NCT01011387|E1|Reported Event|NPWT System|Negative Pressure Wound Therapy
927554|NCT01011309|B4|Baseline|Total|Total of all reporting groups
927656|NCT01010971|P3|Participant Flow|Placebo|Placebo once daily
927559|NCT01011309|P2|Participant Flow|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
927560|NCT01011309|P1|Participant Flow|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
927561|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
927562|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
927563|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
927564|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
927565|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
927566|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
927567|NCT01011309|O3|Outcome|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
927568|NCT01011309|O2|Outcome|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
927569|NCT01011309|O1|Outcome|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
927570|NCT01011309|E3|Reported Event|Chemotherapy|Sodium stibogluconate (SSG) given 20 mg/kg/day IV for 20 days.
927571|NCT01011309|E2|Reported Event|Immunotherapy v1.6|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 14, and 28.
927572|NCT01011309|E1|Reported Event|Immunotherapy v1.4/1.5|10 mcg LEISH-F2 antigen + 25 mcg MPL-SE adjuvant given as three subcutaneous injections on Days 0, 28, and 56.
927573|NCT01011283|B3|Baseline|Total|Total of all reporting groups
927574|NCT01011283|B2|Baseline|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
927575|NCT01011283|B1|Baseline|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
927576|NCT01011283|P2|Participant Flow|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
927577|NCT01011283|P1|Participant Flow|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
927578|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
927579|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
927580|NCT01011283|O2|Outcome|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
927581|NCT01011283|O1|Outcome|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
927582|NCT01011283|E2|Reported Event|Azacitidine 75 mg/m^2|azacitidine : azacitidine 75 mg/m^2 /day subcutaneous (SC) injection for 7 days every 28 days
927583|NCT01011283|E1|Reported Event|Decitabine 20 mg/m^2|decitabine : decitabine 20 mg/m^2 /day intravenous (IV) infusion for 5 days every 28 days
927584|NCT01011179|B3|Baseline|Total|Total of all reporting groups
927585|NCT01011179|B2|Baseline|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
927586|NCT01011179|B1|Baseline|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
927641|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
927587|NCT01011179|P2|Participant Flow|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
927588|NCT01011179|P1|Participant Flow|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
927589|NCT01011179|O2|Outcome|Attention Control Group|"Self-Management: Adolescents' own best efforts at managing their JIA"
927590|NCT01011179|O1|Outcome|Internet-based JIA Self-Management Program|Teens Taking Charge: The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
927591|NCT01011179|E2|Reported Event|Internet-based JIA Self-Management Program|Teens Taking Charge : The intervention is a 12-week multi-component treatment protocol that consists of self-management strategies (e.g., how to deal with stress and treatment related symptoms like pain), information (e.g., common problems associated with treatment and disease) and social support (e.g., monitored discussion boards and narratives in the form of written stories and video clips). It will be delivered on a restricted web-site and through regular contact with a trained coach by means of email and/or telephone using standardized scripts.
927592|NCT01011179|E1|Reported Event|Attention Control Group|"Self-Management : Adolescents' own best efforts at managing their JIA"
927593|NCT01011153|B4|Baseline|Total|Total of all reporting groups
927594|NCT01011153|B3|Baseline|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
927595|NCT01011153|B2|Baseline|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
927596|NCT01011153|B1|Baseline|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
927597|NCT01011153|P3|Participant Flow|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
927598|NCT01011153|P2|Participant Flow|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
927599|NCT01011153|P1|Participant Flow|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
927600|NCT01011153|O3|Outcome|Primary Care Physicians|
927601|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|
927602|NCT01011153|O1|Outcome|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
927603|NCT01011153|O4|Outcome|All Partipants|All Participants are the General Dermatologists, Pigmented Skin Lesion Experts and Primary Care Physicians combined.
927604|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
927605|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
927606|NCT01011153|O1|Outcome|Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
927607|NCT01011153|O4|Outcome|MelaFind|MelaFind imaged the 130 cases, the 65 positive cases (i.e., histologically confirmed melanoma) and the 65 negative cases (i.e., histologically confirmed non-melanoma). Sensitivity was calculated based on the correct identification of the 65 positive cases and specificity was calculated based on the correct identification of the 65 negative cases.
927608|NCT01011153|O3|Outcome|Primary Care Physicians|Physicians who are not Board Certified Dermatologists and Pediatricians. Each PCP was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
927609|NCT01011153|O2|Outcome|Pigmented Skin Lesion Experts|Physicians who spend at least 25% of their practice time examining pigmented skin lesions. Each PSL Expert was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
927610|NCT01011153|O1|Outcome|General Dermatologists|General Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consisting of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
927611|NCT01011153|O2|Outcome|MelaFind|MelaFind imaged 130 cases which consisted of 65 positive cases (i.e., histolgoically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma).
927711|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927712|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927612|NCT01011153|O1|Outcome|Dermatologists|Dermatologists were defined as board-certified dermatologists who were General Dermatologists and Pigmented Skin Lesion Experts, according to the Intake Survey. Dermatologists in this group did not participate in previous EOS Protocols 20061 and 20081. Each dermatologist was given up to 130 cases (each one consisting of 3 clinical images and a case history) consistinf of 65 positive cases (i.e., histologically confirmed melanoma) and 65 negative cases (i.e., histologically confirmed non-melanoma)
927613|NCT01011153|E3|Reported Event|Primary Care Physicians|Primary Care Physicians(PCPs) were defined as physicians who deliver primary care service to adult patients (e.g., internists, general practitioners, family practitioners, and geriatricians).
927614|NCT01011153|E2|Reported Event|Pigmented Skin Lesion Experts|Pigmented Skin Lesion Expert were defined as board-certified dermatologists who spend at least 25% of their practice time evaluating pigmented skin lesions (PSLs)
927615|NCT01011153|E1|Reported Event|General Dermatologists|Dermatologists were defined as board-certified dermatologists who did not participate in previous EOS Protocols 20061 and 20081
927616|NCT01011075|B1|Baseline|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
927617|NCT01011075|P1|Participant Flow|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
927618|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
927619|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
927657|NCT01010971|P2|Participant Flow|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927620|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
927621|NCT01011075|O1|Outcome|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
927622|NCT01011075|E1|Reported Event|Imatinib Mesylate and Paclitaxel|Experimental: Treatment (enzyme inhibitor, chemotherapy) Patients receive paclitaxel IV on days 3, 10, and 17 and imatinib mesylate PO QD on days 1-4, 8-11, and 15-18. Treatment repeats every 28 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
927623|NCT01011049|B5|Baseline|Total|Total of all reporting groups
927624|NCT01011049|B4|Baseline|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
927625|NCT01011049|B3|Baseline|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
927626|NCT01011049|B2|Baseline|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
927627|NCT01011049|B1|Baseline|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
927628|NCT01011049|P4|Participant Flow|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
927629|NCT01011049|P3|Participant Flow|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
927630|NCT01011049|P2|Participant Flow|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
927631|NCT01011049|P1|Participant Flow|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
927632|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
927633|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
927634|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
927635|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
927636|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
927637|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
927638|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
927639|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
927640|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
927642|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
927643|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
927644|NCT01011049|O4|Outcome|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
927645|NCT01011049|O3|Outcome|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
927646|NCT01011049|O2|Outcome|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
927647|NCT01011049|O1|Outcome|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
927648|NCT01011049|E4|Reported Event|Group 4: Fluzone ID After Fluzone IM|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone intramuscular (IM) vaccine in Study FID31 (NCT00772109)
927649|NCT01011049|E3|Reported Event|Group 3: Fluzone IM After Fluzone IM|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone IM vaccine in Study FID31 (NCT00772109)
927650|NCT01011049|E2|Reported Event|Group 2: Fluzone IM After Fluzone ID|Participants who received Fluzone intramuscular (IM) vaccine after receiving Fluzone intradermal (ID) vaccine in Study FID31 (NCT00772109)
927651|NCT01011049|E1|Reported Event|Group 1: Fluzone ID After Fluzone ID|Participants who received Fluzone intradermal (ID) vaccine after receiving Fluzone ID vaccine in Study FID31 (NCT00772109)
927652|NCT01010971|B4|Baseline|Total|Total of all reporting groups
927653|NCT01010971|B3|Baseline|Placebo|Placebo once daily
927654|NCT01010971|B2|Baseline|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927655|NCT01010971|B1|Baseline|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927660|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927661|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927662|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927663|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927664|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927665|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927666|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927667|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927668|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927669|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927670|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927671|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927672|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927673|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927674|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927675|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927676|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927677|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927678|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927679|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927680|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927681|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927682|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927683|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927684|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927685|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927686|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927687|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927688|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927689|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927690|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927691|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927692|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927693|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927694|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927695|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927696|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927697|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927698|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927699|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927700|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927701|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927702|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927703|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927704|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927705|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927706|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927707|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927708|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927709|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927710|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927714|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927715|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927716|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927717|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927718|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927719|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927720|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927721|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927722|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927723|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927724|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927725|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927726|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927727|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927728|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927729|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927730|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927731|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927732|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927733|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927734|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927735|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927736|NCT01010971|O3|Outcome|Placebo|Placebo once daily
927737|NCT01010971|O2|Outcome|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927738|NCT01010971|O1|Outcome|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927739|NCT01010971|E3|Reported Event|Placebo|Placebo once daily
927740|NCT01010971|E2|Reported Event|Ciclesonide HFA Nasal Aerosol 80 μg|80 μg once daily
927741|NCT01010971|E1|Reported Event|Ciclesonide HFA Nasal Aerosol 160 μg|160 μg once daily
927742|NCT01010932|B1|Baseline|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
927743|NCT01010932|P1|Participant Flow|TOF MRA Followed by Dotarem-enhanced MRA|"Each patient will undergo a Time Of Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA.~Each patient will be scheduled to undergo CTA either before TOF MRA or after Dotarem-enhanced MRA. CTA will be used as standard of truth."
927744|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
927745|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
927746|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
927747|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
927748|NCT01010932|O2|Outcome|TOF MRA|Patients benefiting from an MRA with no contrast medium administration
927749|NCT01010932|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after Dotarem IV administration
927750|NCT01010932|E4|Reported Event|Patients Discontinued Without Dotarem Administration|Patients withdrawn before administration of Dotarem whatever the reason
927751|NCT01010932|E3|Reported Event|Computerized Tomography Angiography (CTA)|Patients benefiting from a CT angiography with an IV injection of iodinated contrast medium
927752|NCT01010932|E2|Reported Event|TOF MRA|Patients benefiting from a MR angiography with no contrast medium administration
927753|NCT01010932|E1|Reported Event|Dotarem MRA|Patients benefiting from a MR angiography after an IV administration of Dotarem
927754|NCT01010906|B7|Baseline|Total|Total of all reporting groups
927755|NCT01010906|B6|Baseline|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
927756|NCT01010906|B5|Baseline|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
927757|NCT01010906|B4|Baseline|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927758|NCT01010906|B3|Baseline|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
927759|NCT01010906|B2|Baseline|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927760|NCT01010906|B1|Baseline|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
927761|NCT01010906|P6|Participant Flow|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
927762|NCT01010906|P5|Participant Flow|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
927763|NCT01010906|P4|Participant Flow|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927764|NCT01010906|P3|Participant Flow|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
927765|NCT01010906|P2|Participant Flow|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927766|NCT01010906|P1|Participant Flow|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
927767|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
927768|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
927769|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927770|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
927771|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927772|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
927773|NCT01010906|O6|Outcome|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
927774|NCT01010906|O5|Outcome|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
927775|NCT01010906|O4|Outcome|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927776|NCT01010906|O3|Outcome|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
927777|NCT01010906|O2|Outcome|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927778|NCT01010906|O1|Outcome|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
927779|NCT01010906|E6|Reported Event|Healthy Control for Severe HI|Healthy matched control participants administered a single 200 mg oral tablet of vaniprevir
927780|NCT01010906|E5|Reported Event|Severe HI|Participants with severe HI administered a single 200 mg oral tablet of vaniprevir
927781|NCT01010906|E4|Reported Event|Healthy Control for Moderate HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
927782|NCT01010906|E3|Reported Event|Moderate HI|Participants with moderate HI administered a single 300 mg oral tablet of vaniprevir
927783|NCT01010906|E2|Reported Event|Healthy Control for Mild HI|Healthy matched control participants administered a single 300 mg oral tablet of vaniprevir
951250|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
927784|NCT01010906|E1|Reported Event|Mild Hepatic Insufficiency (HI)|Participants with mild hepatic insufficiency (HI) administered a single 300 mg oral tablet of vaniprevir
927785|NCT01010776|B1|Baseline|Paliperidone ER - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927786|NCT01010776|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of main phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927787|NCT01010776|O1|Outcome|Paliperidone ER-Main Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927788|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Single oral dose of paliperidone ER tablet within the range of 3 to 12 mg once a day was administered for 26 weeks. Dosage was adjusted as per the investigator’s discretion.
927789|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927790|NCT01010776|O1|Outcome|Paliperidone ER- Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927791|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927792|NCT01010776|O1|Outcome|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927793|NCT01010776|O1|Outcome|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally, once daily for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927794|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927795|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927796|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927797|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927798|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927799|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927896|NCT01010477|E2|Reported Event|Placebo|Receives placebo (piperine)nasal spray
927800|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927801|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) will be administered orally once daily for 26 weeks of Main Phase. and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927802|NCT01010776|O1|Outcome|Paliperidone ER-Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927803|NCT01010776|O1|Outcome|Paliperidone (ER) - Main Phase Plus Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927804|NCT01010776|O1|Outcome|Paliperidone Extended Release (ER) - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927805|NCT01010776|E2|Reported Event|Paliperidone ER - Extension Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase and for additional 26 weeks of Extension Phase to participants who continued with Extension Phase. Dosage was adjusted as per the Investigator’s discretion.
927806|NCT01010776|E1|Reported Event|Paliperidone ER - Main Phase|Paliperidone ER tablets in the flexible dose ranging from 3 to 12 milligram (mg) was administered orally once daily for 26 weeks of Main Phase. Dosage was adjusted as per the Investigator’s discretion.
927807|NCT01010750|B7|Baseline|Total|Total of all reporting groups
927808|NCT01010750|B6|Baseline|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|
927809|NCT01010750|B5|Baseline|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|
927810|NCT01010750|B4|Baseline|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|
927811|NCT01010750|B3|Baseline|Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg|
927812|NCT01010750|B2|Baseline|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|
927813|NCT01010750|B1|Baseline|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|
927814|NCT01010750|P6|Participant Flow|MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg|MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo
927815|NCT01010750|P5|Participant Flow|MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo|MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo
927816|NCT01010750|P4|Participant Flow|Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg|LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo
927817|NCT01010750|P3|Participant Flow|Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg|LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
927818|NCT01010750|P2|Participant Flow|LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg|LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo
927819|NCT01010750|P1|Participant Flow|LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo|Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo
927820|NCT01010750|O3|Outcome|Placebo|
927821|NCT01010750|O2|Outcome|MAS-IR 20 mg|
927822|NCT01010750|O1|Outcome|LDX 50 mg|
927823|NCT01010750|O3|Outcome|Placebo|
927824|NCT01010750|O2|Outcome|MAS-IR 20 mg|
927825|NCT01010750|O1|Outcome|LDX 50 mg|
927826|NCT01010750|O3|Outcome|Placebo|
927827|NCT01010750|O2|Outcome|MAS-IR 20 mg|
927828|NCT01010750|O1|Outcome|LDX 50 mg|
927829|NCT01010750|O3|Outcome|Placebo|
927830|NCT01010750|O2|Outcome|MAS-IR 20 mg|
927831|NCT01010750|O1|Outcome|LDX 50 mg|
927832|NCT01010750|O3|Outcome|Placebo|
927833|NCT01010750|O2|Outcome|MAS-IR 20 mg|
927834|NCT01010750|O1|Outcome|LDX 50 mg|
927835|NCT01010750|O3|Outcome|Placebo|
927836|NCT01010750|O2|Outcome|MAS-IR 20 mg|
927837|NCT01010750|O1|Outcome|LDX 50 mg|
927838|NCT01010750|E3|Reported Event|Placebo|
927839|NCT01010750|E2|Reported Event|MAS-IR 20 mg|
927840|NCT01010750|E1|Reported Event|LDX 50 mg|
927841|NCT01010633|B3|Baseline|Total|Total of all reporting groups
927842|NCT01010633|B2|Baseline|Vehicle|Vehicle of loteprednol etabonate
927843|NCT01010633|B1|Baseline|Loteprednol|Loteprednol etabonate 0.5%
927844|NCT01010633|P2|Participant Flow|Vehicle|Vehicle of loteprednol etabonate
927845|NCT01010633|P1|Participant Flow|Loteprednol|Loteprednol etabonate 0.5%
927846|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
927847|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
927848|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
927849|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
927850|NCT01010633|O2|Outcome|Vehicle|Vehicle of Loteprednol Etabonate
927851|NCT01010633|O1|Outcome|Loteprednol|Loteprednol Etabonate 0.5%
927852|NCT01010633|E2|Reported Event|Vehicle|Vehicle of loteprednol etabonate
927853|NCT01010633|E1|Reported Event|Loteprednol|Loteprednol etabonate 0.5%
927854|NCT01010568|B1|Baseline|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
927855|NCT01010568|P1|Participant Flow|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
927897|NCT01010477|E1|Reported Event|NNS Active|Receives nicotine (active) nasal spray
927898|NCT01010399|B1|Baseline|Boosted Lexiva With Lovaza|
927856|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
927857|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|Ofatumumab and Bendamustine in Previously Treated Chronic Lymphocytic Leukemia
927858|NCT01010568|O1|Outcome|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
927859|NCT01010568|E1|Reported Event|Ofatumumab and Bendamustine|"Ofatumumab and Bendamustine~Ofatumumab and Bendamustine: Ofatumumab 300-mg IV on Day 1 of week -1 and then 1000 mg on Day 1 of each cycle for 6 cycles Bendamustine 70 mg/m2 IV on days 1 and 2 of each cycle for 6 cycles"
927860|NCT01010555|B1|Baseline|Overall|This reporting group includes all enrolled subjects.
927861|NCT01010555|P2|Participant Flow|Senofilcon A/Enfilcon A, Then Lotrafilcon b/Balafilcon A|Senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
927862|NCT01010555|P1|Participant Flow|Lotrafilcon B/Balafilcon A, Then Senofilcon A/Enfilcon A|Lotrafilcon B contact lens randomly assigned to one eye, with balafilcon A contact lens assigned to the fellow eye for contralateral daily wear. Both products worn for 4 weeks, followed by senofilcon A contact lens randomly assigned to one eye, with enfilcon A contact lens assigned to the fellow eye for an additional 4 weeks of contralateral daily wear.
927863|NCT01010555|O4|Outcome|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927864|NCT01010555|O3|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927865|NCT01010555|O2|Outcome|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927866|NCT01010555|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927867|NCT01010555|E4|Reported Event|Enfilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927868|NCT01010555|E3|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927869|NCT01010555|E2|Reported Event|Balafilcon A|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927870|NCT01010555|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens worn in one eye on a daily wear basis for 4 weeks.
927871|NCT01010503|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927872|NCT01010503|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927873|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927874|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927875|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927876|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927877|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927878|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927879|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927880|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927881|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927882|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927883|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927884|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927885|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927886|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927887|NCT01010503|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927888|NCT01010503|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for a maximum of 20 weeks (total of 6 infusions).
927889|NCT01010477|B3|Baseline|Total|Total of all reporting groups
927890|NCT01010477|B2|Baseline|Placebo NS|Receives placebo (piperine containing) nasal spray
927891|NCT01010477|B1|Baseline|NNS Active|Receives nicotine (active) nasal spray
927892|NCT01010477|P2|Participant Flow|Placebo|Receives placebo (piperine)nasal spray
927893|NCT01010477|P1|Participant Flow|NNS Active|Receives active nicotine containing Nasal spray
927894|NCT01010477|O2|Outcome|Placebo|Receives placebo (piperine)nasal spray
927895|NCT01010477|O1|Outcome|NNS Active|Receives nicotine (active ) nasal spray
927904|NCT01010282|B3|Baseline|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927905|NCT01010282|B2|Baseline|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927906|NCT01010282|B1|Baseline|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927907|NCT01010282|P3|Participant Flow|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927908|NCT01010282|P2|Participant Flow|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927909|NCT01010282|P1|Participant Flow|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927910|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927911|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927912|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927913|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927914|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927915|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927916|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927917|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927918|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927919|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927920|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927921|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927922|NCT01010282|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927923|NCT01010282|O2|Outcome|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927924|NCT01010282|O1|Outcome|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927925|NCT01010282|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
927926|NCT01010282|E2|Reported Event|Artificial Tears Formulation 2|Artificial Tears Formulation 2
927927|NCT01010282|E1|Reported Event|Artificial Tears Formulation 1|Artificial Tears Formulation 1
927928|NCT01010230|B3|Baseline|Total|Total of all reporting groups
927929|NCT01010230|B2|Baseline|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927930|NCT01010230|B1|Baseline|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927931|NCT01010230|P2|Participant Flow|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927932|NCT01010230|P1|Participant Flow|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927933|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927934|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927935|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
928101|NCT01009619|E2|Reported Event|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
927936|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927937|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927938|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
928065|NCT01009645|B1|Baseline|Fact Only|The educational message used will contain facts only.
928066|NCT01009645|P4|Participant Flow|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
927939|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927940|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927941|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927942|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927943|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927944|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927945|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927946|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927947|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927948|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927949|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927950|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927977|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927951|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927952|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927953|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927954|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927955|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927956|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927957|NCT01010230|O2|Outcome|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927958|NCT01010230|O1|Outcome|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927959|NCT01010230|E2|Reported Event|Placebo Device|"The placebo device is identical in appearance and function to the active platform; except when activated, it emits the same sound as the active device but does not deliver the vibration.~Placebo device: Participants were randomly assigned to stand on a placebo device for 10 minutes twice daily for one year. The study hypothesized participants in the intervention arm would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo arm."
927960|NCT01010230|E1|Reported Event|LMHF Mechanical Stimulation|"Low magnitude, high frequency mechanical stimulation device (vibrating) platform~LMHF mechanical stimulation active device: Participants were randomly assigned to stand on a low magnitude, high frequency mechanical stimulation device (vibrating) platform for 10 minutes twice daily for one year. The study hypothesized participants randomized to the active device would demonstrate improved total bone mineral content for height, spinal and tibial bone mineral density and tibial bone strength when compared to those who were randomized to the placebo intervention."
927961|NCT01010204|B3|Baseline|Total|Total of all reporting groups
927962|NCT01010204|B2|Baseline|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927975|NCT01010061|P2|Participant Flow|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927976|NCT01010061|P1|Participant Flow|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927963|NCT01010204|B1|Baseline|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927964|NCT01010204|P2|Participant Flow|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927965|NCT01010204|P1|Participant Flow|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927966|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927967|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927968|NCT01010204|O2|Outcome|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927969|NCT01010204|O1|Outcome|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927992|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927970|NCT01010204|E2|Reported Event|Placebo|"We will be using placebo in a randomized, controlled, and blinded trial to compare to varenicline in subjects with bipolar disorder.~Placebo: Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927971|NCT01010204|E1|Reported Event|Varenicline|"We will be comparing Varenicline to placebo in a double-blind placebo controlled, randomized study.~Varenicline (Chantix): Patients will be randomly assigned to receive either varenicline or placebo for 12 weeks. Patients assigned to varenicline will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study, i.e. 11 weeks. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline. Patients will be instructed to take study medication after meals with a glass of water."
927972|NCT01010061|B3|Baseline|Total|Total of all reporting groups
927973|NCT01010061|B2|Baseline|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927974|NCT01010061|B1|Baseline|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
928057|NCT01009762|O2|Outcome|Placebo|participants receiving placebo (=saline)
928058|NCT01009762|O1|Outcome|Vaccinee|participants receiving the vaccine
927978|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927979|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927980|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927981|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [First infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927982|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927983|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927984|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927985|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927986|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927987|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927988|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927989|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927990|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927991|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
928099|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928311|NCT01009333|E2|Reported Event|Medium InterStim Rate Setting at 14 Hz|
927993|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927994|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927995|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927996|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
927997|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
927998|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
928059|NCT01009762|E2|Reported Event|Placebo|Participants receiving placebo (saline)
928060|NCT01009762|E1|Reported Event|Vaccinee|"participants receiving the vaccine called AFO-18"
928061|NCT01009645|B5|Baseline|Total|Total of all reporting groups
927999|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
928000|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
928001|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
928002|NCT01010061|O2|Outcome|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
928003|NCT01010061|O1|Outcome|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
928004|NCT01010061|E2|Reported Event|Chlorambucil (Clb)|Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
928005|NCT01010061|E1|Reported Event|Obinutuzumab + Chlorambucil (GClb)|Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
928006|NCT01010009|B4|Baseline|Total|Total of all reporting groups
928007|NCT01010009|B3|Baseline|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
928008|NCT01010009|B2|Baseline|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
928009|NCT01010009|B1|Baseline|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
928010|NCT01010009|P3|Participant Flow|Placebo Then Resveratrol 250mg Then Resveratrol 500mg|
928011|NCT01010009|P2|Participant Flow|Resveratrol 500mg Then Placebo Then Resveratrol 250mg|
928012|NCT01010009|P1|Participant Flow|Resveratrol 250mg Then Resveratrol 500mg Then Placebo|
928013|NCT01010009|O3|Outcome|Placebo|
928014|NCT01010009|O2|Outcome|Resveratrol 500mg|
928015|NCT01010009|O1|Outcome|Resveratrol 250mg|
928016|NCT01010009|O3|Outcome|Placebo|
928017|NCT01010009|O2|Outcome|Resveratrol 500mg|
928018|NCT01010009|O1|Outcome|Resveratrol 250mg|
928019|NCT01010009|O3|Outcome|Placebo|
928020|NCT01010009|O2|Outcome|Resveratrol 500mg|
928021|NCT01010009|O1|Outcome|Resveratrol 250mg|
928022|NCT01010009|E3|Reported Event|Placebo|
928023|NCT01010009|E2|Reported Event|Resveratrol 500mg|
928024|NCT01010009|E1|Reported Event|Resveratrol 250mg|
928025|NCT01009983|B1|Baseline|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
928026|NCT01009983|P1|Participant Flow|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
928027|NCT01009983|O1|Outcome|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
928138|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928028|NCT01009983|E1|Reported Event|Arm 1|"Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.~panitumumab: Given IV~paclitaxel: Given IV~carboplatin: Given IV~laboratory biomarker analysis: Correlative study~immunohistochemistry staining method: Correlative study"
928029|NCT01009931|B1|Baseline|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
928030|NCT01009931|P1|Participant Flow|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
928031|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
928062|NCT01009645|B4|Baseline|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
928063|NCT01009645|B3|Baseline|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
928064|NCT01009645|B2|Baseline|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
928032|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
928033|NCT01009931|O1|Outcome|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
928034|NCT01009931|E1|Reported Event|TPA + Dexamethasone and CMT|"12-O-tetradecanoylphorbol-13-acetate (TPA) plus Dexamethasone & Choline magnesium trisalicylate (Trilisate)~12-O-tetradecanoylphorbol-13-acetate: The initial dose of TPA will be 1 mg/week x 3 weeks (Day 1, 8, 15).~Up to 6 cycles.~Dexamethasone: Dexamethasone 10 mg PO qid will start 24h prior to TPA and continue for 24h after TPA x 3 weeks. Up to 6 cycles.~Choline magnesium trisalicylate: Choline magnesium trisalicylate 1500 mg PO TID will begin 24h prior to TPA and continue for 24h post TPA x 3 weeks.~Up to 6 cycles."
928035|NCT01009840|B1|Baseline|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928036|NCT01009840|P1|Participant Flow|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the pharmacokinetic (PK)-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to hematopoietic stem cell transplant (HSCT).
928037|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928038|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928039|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928040|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928041|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928042|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928043|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928100|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928301|NCT01009333|O3|Outcome|High InterStim Rate Setting at 25 Hz|
928044|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928045|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928046|NCT01009840|O1|Outcome|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928047|NCT01009840|E1|Reported Event|IV Busulfan|Intravenous (IV) busulfan was administered as a single daily 3-hour continuous infusion based on the PK-directed dose recommendation for 4 days beginning on Day -5 followed by a single bortezomib 1.3 mg/m^2 dose administered as a 3 to 5-second bolus IV injection on Day -1 prior to HSCT.
928048|NCT01009762|B3|Baseline|Total|Total of all reporting groups
928049|NCT01009762|B2|Baseline|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
928050|NCT01009762|B1|Baseline|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
928051|NCT01009762|P2|Participant Flow|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
928052|NCT01009762|P1|Participant Flow|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
928053|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
928054|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
928055|NCT01009762|O2|Outcome|AFO-18 Vaccinated|Patients receiving the experimental therapeutic vaccine
928056|NCT01009762|O1|Outcome|Saline|Sterile saline for injection is used as placebo arm. It is administered i.m. in the same way as for the active vaccine, week 0, 2, 4, 8.
928067|NCT01009645|P3|Participant Flow|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
928068|NCT01009645|P2|Participant Flow|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
928069|NCT01009645|P1|Participant Flow|Fact Only|The educational message used will contain facts only.
928070|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
928071|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
928072|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
928073|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
928074|NCT01009645|O4|Outcome|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
928075|NCT01009645|O3|Outcome|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
928076|NCT01009645|O2|Outcome|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
928077|NCT01009645|O1|Outcome|Fact Only|The educational message used will contain facts only.
928078|NCT01009645|E4|Reported Event|Control|This arm will receive fact/myth educational materials originally developed and used by the CDC.
928079|NCT01009645|E3|Reported Event|Fact, Myth, Why|The educational material seen by this arm will contain myths, facts, and refutations of the myths.
928080|NCT01009645|E2|Reported Event|Fact and Myth|The educational material seen by this arm will contain facts and myths only.
928081|NCT01009645|E1|Reported Event|Fact Only|The educational message used will contain facts only.
928082|NCT01009619|B3|Baseline|Total|Total of all reporting groups
928083|NCT01009619|B2|Baseline|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928084|NCT01009619|B1|Baseline|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928085|NCT01009619|P2|Participant Flow|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928086|NCT01009619|P1|Participant Flow|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928087|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928088|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928089|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928090|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928091|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928092|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928093|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928094|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928095|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928096|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928097|NCT01009619|O2|Outcome|Placebo|Placebo daily for 5 days, followed by placebo three times a week (Mon.-Wed.-Fri.) until end of study.
928098|NCT01009619|O1|Outcome|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928102|NCT01009619|E1|Reported Event|Azithromycin|250 mg daily for 5 days, followed by 250 mg three times a week (Mon.-Wed.-Fri.) until the end of study
928103|NCT01009580|B3|Baseline|Total|Total of all reporting groups
928104|NCT01009580|B2|Baseline|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
928105|NCT01009580|B1|Baseline|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
928106|NCT01009580|P2|Participant Flow|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
928107|NCT01009580|P1|Participant Flow|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
928108|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
928109|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
928110|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
928194|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928111|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
928112|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
928113|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
928114|NCT01009580|O2|Outcome|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
928115|NCT01009580|O1|Outcome|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
928116|NCT01009580|E2|Reported Event|BIAsp 30 BID|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
928117|NCT01009580|E1|Reported Event|IDegAsp BID|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
928118|NCT01009554|B3|Baseline|Total|Total of all reporting groups
928119|NCT01009554|B2|Baseline|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928120|NCT01009554|B1|Baseline|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928121|NCT01009554|P2|Participant Flow|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928122|NCT01009554|P1|Participant Flow|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928123|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928124|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928125|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928126|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928127|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928128|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928129|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928130|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928131|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928132|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928133|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928134|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928135|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928136|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928137|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928139|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928140|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928141|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928142|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928143|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928144|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928145|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928146|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928147|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928148|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928149|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928150|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928151|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928152|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928153|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928154|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928155|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928156|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928157|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928158|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928159|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928160|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928161|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928162|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928163|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928164|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928165|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928166|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928167|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928168|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928169|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928170|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928171|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928172|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928173|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928174|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928175|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928176|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928177|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928178|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928179|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928180|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928181|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928182|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928183|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928184|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928185|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928186|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928187|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928188|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928189|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928190|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928191|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928192|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928193|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928195|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928196|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928197|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928198|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928199|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928200|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928201|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928202|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928203|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928204|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928205|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928206|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928207|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928208|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928209|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928210|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928211|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928212|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928213|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928214|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928215|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928216|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928217|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928218|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928219|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928220|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928221|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928222|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928223|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928224|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928225|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928226|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928227|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928228|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928229|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928230|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928231|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928232|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928233|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928234|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928235|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928236|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928237|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928238|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928239|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928240|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928241|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928242|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928243|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928244|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928245|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928246|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928247|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928248|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928249|NCT01009554|O2|Outcome|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928250|NCT01009554|O1|Outcome|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928251|NCT01009554|E2|Reported Event|11794-050 (1.5% Potassium Oxalate & pH 4.2 Mouth Rinse)|Crest® Cavity Protection followed by 1.5% Potassium Oxalate & pH 4.2 Mouth Rinse (Brushing followed by Mouth Rinse)
928252|NCT01009554|E1|Reported Event|Crest® Regular Toothpaste|Crest® Cavity Protection Regular Toothpaste (Brushing Only)
928253|NCT01009515|B1|Baseline|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
928254|NCT01009515|P1|Participant Flow|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
928255|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
928256|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
928257|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
928258|NCT01009515|O1|Outcome|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
928259|NCT01009515|E1|Reported Event|Chemotherapy Combination|"Chemotherapy Combination of paclitaxel, carboplatin, temozolomide: Carboplatin at an AUC of 5 on Day 1, paclitaxel at 175 mg/m2 on Day 1, and temozolomide at 125 mg/m2 Day 2-Day 6, on a 28 day cycle.~Paclitaxel, carboplatin, temozolomide: Combination chemotherapy was administered for up to 6 cycles"
928260|NCT01009463|B5|Baseline|Total|Total of all reporting groups
928302|NCT01009333|O2|Outcome|Medium InterStim Rate Setting at 14 Hz|
928303|NCT01009333|O1|Outcome|Low InterStim Rate Setting at 5.2 Hz|
928261|NCT01009463|B4|Baseline|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928262|NCT01009463|B3|Baseline|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928263|NCT01009463|B2|Baseline|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928264|NCT01009463|B1|Baseline|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928265|NCT01009463|P5|Participant Flow|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928266|NCT01009463|P4|Participant Flow|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928319|NCT01009203|E1|Reported Event|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
928320|NCT01009138|B3|Baseline|Total|Total of all reporting groups
928267|NCT01009463|P3|Participant Flow|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928268|NCT01009463|P2|Participant Flow|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928269|NCT01009463|P1|Participant Flow|FP/SAL 250/50 µg BID|Participants (Par.) were instructed to take open label Fluticasone Propionate and Salmeterol (FP/SAL) 250/50 microgram (µg) twice daily (BID) from the ACCUHALER/DISKUS, one inhalation each morning and evening with approximately 12 hours between doses. In addition, all par. were provided supplemental albuterol/salbutamol (metered dose inhaler [MDI] and/or nebules) to be used as needed throughout the study.
928270|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928271|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928272|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928273|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928274|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928275|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928276|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928277|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928278|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928279|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928280|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928281|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study. )
928282|NCT01009463|O4|Outcome|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928283|NCT01009463|O3|Outcome|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928284|NCT01009463|O2|Outcome|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928285|NCT01009463|O1|Outcome|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928286|NCT01009463|E4|Reported Event|FF/VI 200/25 µg QD|Participants received a FF/VI 200/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928287|NCT01009463|E3|Reported Event|FF/VI 100/25 µg QD|Participants received a FF/VI 100/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928521|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
928288|NCT01009463|E2|Reported Event|FF/VI 50/25 µg QD|Participants received a Fluticasone Furoate/Vilanterol (FF/VI) 50/25 µg inhalation powder QD in the morning from the DPI for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928289|NCT01009463|E1|Reported Event|VI 25 µg QD|Participants received a Vilanterol (VI) 25 µg dry inhalation powder once daily (QD) in the morning from the Dry Powder Inhaler (DPI) for the duration of the 52 weeks. In addition, all participants were provided supplemental albuterol/salbutamol (MDI and/or nebules) to be used as needed throughout the study.
928290|NCT01009346|B1|Baseline|Study Arm|"Drug: RAD001~Other Names:~Everolimus~Dose Level -1 2.5mg/day~Dose Level 1 5mg/day*~Dose Level 2 10mg/day~MTD RAD001 Drug: Cetuximab~Other Names:~Erbitux~250mg/m2/week Drug: Cisplatin~Other Names:~cisplatinum CDDP cis-diamminedichloroplatinum(II)~40mg/m2 Day 1, 8 every 28 days Drug: Carboplatin~Other Names:~cis-Diammine(1,1-cyclobutanedicarboxylato)platinum(II)~Carboplatin will be administered on Day1 and Day 8 of each 28 day cycle to a target AUC of 3 over 30 minutes. Carboplatin will be dosed using the Calvert formula:~Total dose (mg) = (target AUC) x (glomerular filtration rate + 25) Creatinine clearance will be used to estimate the GFR. The Cockgroft-Gault formula will be used to estimate the creatinine clearance."
928291|NCT01009346|P1|Participant Flow|RAD001|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
928292|NCT01009346|O1|Outcome|Study Arm (RAD001)|Phase I will be a dose finding study to determine the maximum tolerated dose (MTD) of daily RAD001 in combination with weekly cetuximab and cisplatin on Day 1, 8 of each 28 day cycle. The combination will be explored in successive cohorts of 3 patients each. The first cohort of 3 patients will receive doses corresponding to the first dose level. A full safety evaluation will be conducted when these patients have completed 8 weeks of therapy (2 cycles). If 0/3 patients treated at a dose level have a DLT, then a new cohort of 3 patients will receive treatment at the next dose level. If 1/3 patients have even one DLT, then 3 more patients will be treated at same dose level. If none of these patients has a DLT, then the next higher dose level will be administered to the next cohort of 3 patients; otherwise the inferior dose level will be considered the MTD. If >2/3 patients have a DLT, then the inferior dose level will be considered the MTD.
928293|NCT01009346|E1|Reported Event|Group 1|
928294|NCT01009333|B1|Baseline|All Study Participants|
928295|NCT01009333|P6|Participant Flow|Start at 25 Hz, Then 14 Hz, Then 5.2 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Medium InterStim Rate setting at 14 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
928296|NCT01009333|P5|Participant Flow|Start at 25 Hz, Then 5.2 Hz, Then 14 Hz|Participants started with High InterStim Rate Setting at 25 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
928297|NCT01009333|P4|Participant Flow|Start at 14 Hz, Then 25 Hz, Then 5.2 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to High InterStim Rate setting at 25 Hz, then Low InterStim Rate Settings at 5.2 Hz until they completed all three settings.
928298|NCT01009333|P3|Participant Flow|Start at 14 Hz, Then 5.2 Hz, Then 25 Hz|Participants started with Medium InterStim Rate Setting at 14 Hz, then progressed to Low InterStim Rate setting at 5.2 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
928299|NCT01009333|P2|Participant Flow|Start at 5.2 Hz, Then 25 Hz, Then 14 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to High InterStim Rate Setting at 25 Hz, then Medium InterStim Rate Settings at 14 Hz until they completed all three settings.
928300|NCT01009333|P1|Participant Flow|Start at 5.2 Hz, Then 14 Hz, Then 25 Hz|Participants started with Low InterStim Rate Setting at 5.2 Hz, then progressed to Medium InterStim Rate Setting at 14 Hz, then High InterStim Rate Settings at 25 Hz until they completed all three settings.
928313|NCT01009203|B1|Baseline|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
928314|NCT01009203|P1|Participant Flow|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
928315|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
928316|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
928317|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
928318|NCT01009203|O1|Outcome|Erlotinib and Temsirolimus|Erlotinib at 150 mg by mouth daily + Temsirolimus at 15 mg intravenously weekly. Each cycle is comprised of 28 days.
928321|NCT01009138|B2|Baseline|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928322|NCT01009138|B1|Baseline|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928323|NCT01009138|P2|Participant Flow|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928324|NCT01009138|P1|Participant Flow|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928325|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928326|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928327|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928328|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928329|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928330|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928331|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928332|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928395|NCT01009086|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 90 mg group. Participants received SC injections of ustekinumab 90 mg at Weeks 0 and 4 and 16.
929111|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
928333|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928334|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928377|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928335|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928336|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928337|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928338|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928339|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928340|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928341|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928342|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928343|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928344|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928345|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928346|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928347|NCT01009138|O2|Outcome|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928348|NCT01009138|O1|Outcome|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928402|NCT01009047|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928637|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
928638|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
928349|NCT01009138|E2|Reported Event|Standard Diabetes Education|"Standard Diabetes Education Lessons with social Contact and Acquisition of Knowledge.~Standard Diabetes Education: Standard Diabetes Education Lesson including~Health Care and specific Topics (e. g. Blood Pressure)~Social Aspects of Living with Diabetes~Diabetes Complications~Sports, Activities and Exercise~Healthy and unhealthy Food, Vitamins, Cooking Recommendations and Recipes~Foot Care: Exercises, Care and Control, Sensibility, Injuries, diabetic Neuropathy"
928350|NCT01009138|E1|Reported Event|Diabetes-Specific CBT (DS-CBT)|"Cognitive Behavioral Intervention (Group) focusing on Diabetes-Specific Problems~Diabetes-Specific CBT (DS-CBT): 5 Group Sessions with a duration of 90 Minutes each, including the following cognitive-behavioral Intervention Methods focusing on Diabetes Distress and Hassles:~Problem Analysis and Definition~Problem Solving Intervention~Cognitive Restructuring~Activation of personal and social Resources~Goal Definition and Agreement"
928351|NCT01009099|B3|Baseline|Total|Total of all reporting groups
928352|NCT01009099|B2|Baseline|Arm 2|"exercise training~exercise training: treadmill exercise training"
928353|NCT01009099|B1|Baseline|Arm 1|"exercise training with breathing retraining~breathing retraining: breathing retraining using a metronome~exercise training: treadmill exercise training"
928354|NCT01009099|P2|Participant Flow|Exercise Training|treadmill exercise training
928355|NCT01009099|P1|Participant Flow|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
928356|NCT01009099|O2|Outcome|Exercise Training|treadmill exercise training
928357|NCT01009099|O1|Outcome|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
928358|NCT01009099|E2|Reported Event|Exercise Training|treadmill exercise training
928359|NCT01009099|E1|Reported Event|Exercise Training With Breathing Retraining|treadmill exercise training plus breathing retraining using a metranome
928360|NCT01009086|B4|Baseline|Total|Total of all reporting groups
928361|NCT01009086|B3|Baseline|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
928362|NCT01009086|B2|Baseline|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
928363|NCT01009086|B1|Baseline|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
928364|NCT01009086|P3|Participant Flow|Group 3: USTEKINUMAB 90 MG|Ustekinumab Subcutaneous (SC) injections of 90 mg starting at Week 0 with the last dose at Week 88.
928365|NCT01009086|P2|Participant Flow|Group 2: USTEKINUMAB 45 MG|Ustekinumab Subcutaneous (SC) injections of 45 mg starting at Week 0 with the last dose at Week 88. If Early Escape then participants would receive Ustekinumab 90 mg injections starting Week 16 with the last dose at Week 88.
928366|NCT01009086|P1|Participant Flow|Group 1: PLACEBO|Placebo Subcutaneous (SC) injections at Weeks 0, 4, 16 and 20. If Early Escape then participants would receive Ustekinumab 45 mg injections starting Week 16 with the last dose at Week 88. If Crossover then participants would receive Ustekinumab 45 milligram (mg) injections starting Week 24 with the last dose at Week 88.
928367|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
928368|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928369|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928370|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
928371|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
928372|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
934426|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
928373|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928374|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
928375|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
928376|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
951251|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
928378|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
928379|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
928380|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928381|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928382|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
928383|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
928384|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928385|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928386|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
928387|NCT01009086|O4|Outcome|All Ustekinumab Combined|Participants who received subcutaneous injections of ustekinumab at any dose (45 mg and 90 mg) through Week 88.
928388|NCT01009086|O3|Outcome|Ustekinumab 90 mg|Participants received subcutaneous injections of ustekinumab 90 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928389|NCT01009086|O2|Outcome|Ustekinumab 45 mg|Participants received subcutaneous injections of ustekinumab 45 mg at Weeks 0 and 4 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 90 mg ustekinumab were given at Week 16 and every 12 weeks thereafter with the last dose at Week 88. Participants received subcutaneous injections of placebo at Weeks 20 and 24 to maintain the blind.
928390|NCT01009086|O1|Outcome|Placebo|Participants received subcutaneous injections of placebo at Weeks 0, 4, 16, and 20. At Week 24 participants crossed over to receive subcutaneous injections of ustekinumab 45 milligram (mg) at Weeks 24 and 28 and every 12 weeks thereafter with the last dose at Week 88. If early escape, subcutaneous injections of 45 mg ustekinumab were given at Weeks 16, 20, and 28 and every 12 weeks thereafter with the last dose at Week 88. For participants entering early escape, a subcutaneous placebo injection was given at Week 24 to maintain the blind.
928391|NCT01009086|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 90 mg at Week 0, irrespective of their early escape status.
928392|NCT01009086|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to ustekinumab 45 mg at Week 0, irrespective of their early escape status.
928393|NCT01009086|E5|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 16-108) – participants randomized to placebo who early escaped to ustekinumab 45 mg at Week 16 or who crossed over to ustekinumab 45 mg at Week 24.
928394|NCT01009086|E4|Reported Event|Placebo (After CP)|After Controlled period (Week 16-24) – participants receiving placebo at Weeks 0, 4, 16, and 20, then crossed over to ustekinumab 45 mg at Week 24.
928396|NCT01009086|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-16) - Ustekinumab 45 mg group. Participants received SC injections of ustekinumab 45 mg at Weeks 0 and 4 and 16.
928397|NCT01009086|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-16) - Placebo group. Placebo Subcutaneous (SC) injections will be received at Weeks 0, 4 and 16.
928398|NCT01009047|B3|Baseline|Total|Total of all reporting groups
928399|NCT01009047|B2|Baseline|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928400|NCT01009047|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928401|NCT01009047|P2|Participant Flow|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928403|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928404|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928405|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928406|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928407|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928408|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928409|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928410|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928411|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928412|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928413|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928414|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928415|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928416|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928417|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928418|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928419|NCT01009047|O2|Outcome|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928420|NCT01009047|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928421|NCT01009047|E2|Reported Event|Aripiprazole|Aripiprazole administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4; 10 mg on Days 5, 6 and 7; and then administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
928422|NCT01009047|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER administered as oral capsule at a dose of 6 mg for 1 week and then administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
928423|NCT01009034|B1|Baseline|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
928458|NCT01008904|B1|Baseline|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
928459|NCT01008904|P1|Participant Flow|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide by mouth daily or twice daily for 4 weeks.
928460|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
928424|NCT01009034|P1|Participant Flow|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
928425|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
928426|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
928467|NCT01008722|P1|Participant Flow|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
951252|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
928427|NCT01009034|O1|Outcome|10 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
928428|NCT01009034|E1|Reported Event|12 Male HIV-positive Patients|"Male HIV-positive patients who have been receiving stable antiretroviral therapy that includes maraviroc for a minimum of three months.~Measuring semen samples: Measure semen sample concentrations, obtain semen to plasma ratios across the dosing interval, the area under the concentration time curve of maraviroc in semen, the variability in the penetration of maraviroc into the seminal compartment over the raltegravir dosing period."
928429|NCT01008995|B3|Baseline|Total|Total of all reporting groups
928430|NCT01008995|B2|Baseline|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
928431|NCT01008995|B1|Baseline|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
928432|NCT01008995|P4|Participant Flow|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
928433|NCT01008995|P3|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
928434|NCT01008995|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
928435|NCT01008995|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
928436|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
928437|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
928438|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
928439|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
928440|NCT01008995|O2|Outcome|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
928441|NCT01008995|O1|Outcome|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
928442|NCT01008995|E4|Reported Event|Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving placebo at Week 12 and ustekinumab 45 mg at Week 16
928443|NCT01008995|E3|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After controlled period (Week 12-36) – receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg at Week 12 and Week 16
928444|NCT01008995|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg Group
928445|NCT01008995|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
928446|NCT01008969|B1|Baseline|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
928447|NCT01008969|P1|Participant Flow|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
928448|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
928449|NCT01008969|O1|Outcome|99mTc-sulfur Nanocolloid SPECT/CT|There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
928450|NCT01008969|E1|Reported Event|99mTc-sulfur Nanocolloid SPECT/CT|SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
928451|NCT01008943|B1|Baseline|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
928452|NCT01008943|P1|Participant Flow|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
928453|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
928454|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
928455|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
928456|NCT01008943|O1|Outcome|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
928457|NCT01008943|E1|Reported Event|Autologous Muscle-Derived Cells (AMDC)|Intrasphincteric injection of 200 million AMDC for treatment of SUI in women
934427|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
928461|NCT01008904|O1|Outcome|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
928462|NCT01008904|E1|Reported Event|Supportive Care (Magnesium Oxide)|Patients receive magnesium oxide PO QD or BID for 4 weeks.
928463|NCT01008722|B3|Baseline|Total|Total of all reporting groups
928464|NCT01008722|B2|Baseline|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
928465|NCT01008722|B1|Baseline|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
928466|NCT01008722|P2|Participant Flow|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
928468|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
928469|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
928470|NCT01008722|O2|Outcome|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
928471|NCT01008722|O1|Outcome|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
928472|NCT01008722|E2|Reported Event|CONVENTIONAL|Consecutive cases of patients undergoing Conventional Pulmonary vein isolation (PVI), but being mapped (Focal Impulse and Rotor Mapping) with basket catheters to identify localized rotational or focal sources. FIRM mapping is performed before ablation, but analysis of maps are performed post-hoc and PVI is blinded to the results from FIRM mapping.
928473|NCT01008722|E1|Reported Event|FIRM-Guided|Consecutive cases of patients undergoing Focal Impulse and Rotor Modulation ablation in addition to Conventional Pulmonary vein isolation (PVI)
928474|NCT01008696|B3|Baseline|Total|Total of all reporting groups
928475|NCT01008696|B2|Baseline|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
928476|NCT01008696|B1|Baseline|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
928477|NCT01008696|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
928478|NCT01008696|P1|Participant Flow|Rabeprazole|Rabeprazole 20 milligram (mg) tablet orally once daily before breakfast for 28 to 56 days
928479|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
928480|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
928481|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole group 30 mg capsule orally once daily before breakfast for 28 to 56 days
928482|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
928483|NCT01008696|O2|Outcome|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
928484|NCT01008696|O1|Outcome|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
928485|NCT01008696|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg capsule orally once daily before breakfast for 28 to 56 days
928486|NCT01008696|E1|Reported Event|Rabeprazole|Rabeprazole 20 mg tablet orally once daily before breakfast for 28 to 56 days
928487|NCT01008618|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928488|NCT01008618|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928489|NCT01008618|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928502|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928490|NCT01008618|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928491|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928492|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
951253|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
928493|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928494|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928495|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928496|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928497|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928498|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928499|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928500|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928501|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928617|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928503|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928504|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928520|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
928639|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
928505|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928506|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928507|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928508|NCT01008618|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928509|NCT01008618|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928510|NCT01008618|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928511|NCT01008618|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928512|NCT01008618|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928513|NCT01008618|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928514|NCT01008605|B1|Baseline|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928515|NCT01008605|P1|Participant Flow|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928516|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
928517|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
928518|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
928519|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
928640|NCT01008280|E2|Reported Event|Placebo|"placebo given tid~placebo: placebo pill tid"
928522|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
928523|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
928524|NCT01008605|O8|Outcome|Caverject 20 Mcg Device, 20.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 20.0 mcg in a receptacle. Participants did not receive study medication.
928525|NCT01008605|O7|Outcome|Caverject 20 Mcg Device, 15.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 15.0 mcg in a receptacle. Participants did not receive study medication.
928526|NCT01008605|O6|Outcome|Caverject 20 Mcg Device, 10.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
928527|NCT01008605|O5|Outcome|Caverject 20 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 20 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
928528|NCT01008605|O4|Outcome|Caverject 10 Mcg Device, 10 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 10.0 mcg in a receptacle. Participants did not receive study medication.
928529|NCT01008605|O3|Outcome|Caverject 10 Mcg Device, 7.5 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 7.5 mcg in a receptacle. Participants did not receive study medication.
928530|NCT01008605|O2|Outcome|Caverject 10 Mcg Device, 5.0 Mcg Dose Setting|Participants used the 10 mcg Caverject Impulse Delivery System to expel Alprostadil 5.0 mcg in a receptacle. Participants did not receive study medication.
928531|NCT01008605|O1|Outcome|Caverject 10 Mcg Device, 2.5 Mcg Dose Setting|Participants used the 10 microgram (mcg) Caverject Impulse Delivery System to expel Alprostadil 2.5 mcg in a receptacle. Participants did not receive study medication.
928532|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928533|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928534|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928535|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928536|NCT01008605|O1|Outcome|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928537|NCT01008605|E1|Reported Event|All Participants|All participants who delivered a predefined dose and volume of Alprostadil (prostaglandin E1 [PGE1], Caverject) into a receptacle, using the assigned Caverject Impulse delivery system. Participants did not receive study medication and were monitored during the handling of the Caverject Impulse delivery system.
928538|NCT01008553|B1|Baseline|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928539|NCT01008553|P3|Participant Flow|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928540|NCT01008553|P2|Participant Flow|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928541|NCT01008553|P1|Participant Flow|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928641|NCT01008280|E1|Reported Event|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
928642|NCT01007942|B3|Baseline|Total|Total of all reporting groups
928542|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928543|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928544|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928545|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928546|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928547|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928548|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928549|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928550|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928551|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
934428|NCT00995345|O1|Outcome|Placebo|Tablet
928552|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928553|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928628|NCT01008449|E1|Reported Event|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928629|NCT01008280|B3|Baseline|Total|Total of all reporting groups
928554|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928555|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928556|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch containing fentanyl applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 mcg/hr for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and VAS score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928557|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928558|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928559|NCT01008553|O1|Outcome|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm and thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) score of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928560|NCT01008553|O2|Outcome|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm and thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928561|NCT01008553|O1|Outcome|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm and thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928562|NCT01008553|E3|Reported Event|Placebo (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to placebo group, were administered one-day adhesive transdermal placebo patch indistinguishable from fentanyl in appearance, applied to chest, abdomen, upper arm or thigh and replaced every day. The dose of fentanyl (from titration period) was gradually decreased to prevent withdrawal symptoms and the dose of the matching placebo was gradually increased up to same dose as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928618|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
929585|NCT01005251|B2|Baseline|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
928563|NCT01008553|E2|Reported Event|Fentanyl (Double-blind Period)|Participants meeting the pre-defined criteria for transfer from titration period to double-blind period and randomly assigned to fentanyl group, were administered one-day adhesive transdermal patch containing fentanyl, applied to chest, abdomen, upper arm or thigh and replaced every day, the dose of which was same as the final application dose in the titration period (in the range of 12.5 to 50 mcg/hr). The treatment was continued for 12 weeks.
928564|NCT01008553|E1|Reported Event|Fentanyl (Titration Period)|One-day adhesive transdermal patch (patch containing a drug that is put on the skin so the drug will enter the body through the skin) containing fentanyl (JNS020QD) applied to chest, abdomen, upper arm or thigh and replaced every day, starting at the dose of 12.5 microgram per hour (mcg/hr) for at least first 2 days, which was increased by 12.5 mcg/hr at one time based on the medical examination of number of rescue treatments and visual analog scale (VAS) of the participants. The dose was increased up to maximum of 50 mcg/hr. The treatment was continued for 10-29 days and then the eligible participants from this group were randomly assigned to either of the two groups in the double-blind period.
928565|NCT01008475|B8|Baseline|Total|Total of all reporting groups
928566|NCT01008475|B7|Baseline|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928567|NCT01008475|B6|Baseline|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928568|NCT01008475|B5|Baseline|Randomized Part: SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928569|NCT01008475|B4|Baseline|Safety Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928570|NCT01008475|B3|Baseline|Safety Part: EMD 525797 750 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928571|NCT01008475|B2|Baseline|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928572|NCT01008475|B1|Baseline|Safety Part: EMD 525797 250 mg + Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 once weekly followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928573|NCT01008475|P7|Participant Flow|Randomized Part: EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928574|NCT01008475|P6|Participant Flow|Randomized Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928575|NCT01008475|P5|Participant Flow|Randomized Part: Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928576|NCT01008475|P4|Participant Flow|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928577|NCT01008475|P3|Participant Flow|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928578|NCT01008475|P2|Participant Flow|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928899|NCT01007110|E1|Reported Event|Placebo|soy/corn oil placebo
928579|NCT01008475|P1|Participant Flow|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928580|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928581|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928582|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928583|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928584|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928585|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928586|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928587|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928619|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928588|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928589|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928590|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928630|NCT01008280|B2|Baseline|Placebo|"placebo given tid~placebo: placebo pill tid"
928631|NCT01008280|B1|Baseline|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
928632|NCT01008280|P2|Participant Flow|Placebo|"placebo given tid~placebo: placebo pill tid"
928633|NCT01008280|P1|Participant Flow|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
928591|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928592|NCT01008475|O3|Outcome|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928593|NCT01008475|O2|Outcome|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928594|NCT01008475|O1|Outcome|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928595|NCT01008475|O4|Outcome|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928596|NCT01008475|O3|Outcome|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928597|NCT01008475|O2|Outcome|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928598|NCT01008475|O1|Outcome|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928620|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928621|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928599|NCT01008475|E7|Reported Event|EMD 525797 1000 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928600|NCT01008475|E6|Reported Event|EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented PD (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928601|NCT01008475|E5|Reported Event|Standard of Care (SoC)|Cetuximab was administered at a dose of 400 milligram per square meter (mg/m^2) on Day 1 Cycle 1 (Week 1) as intravenous (IV) infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly followed by irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radiographically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928602|NCT01008475|E4|Reported Event|Safety Part: EMD 525797 1000 mg +SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 1000 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928634|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
928635|NCT01008280|O1|Outcome|Baclofen|"baclofen 10 mg po tid~baclofen: baclofen 10 mg tid"
928636|NCT01008280|O2|Outcome|Placebo|"placebo given tid~placebo: placebo pill tid"
928603|NCT01008475|E3|Reported Event|Safety Part: EMD525797 750 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 750 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928604|NCT01008475|E2|Reported Event|Safety Part: EMD 525797 500 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 500 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928605|NCT01008475|E1|Reported Event|Safety Part: EMD 525797 250 mg + SoC|Cetuximab was administered at a dose of 400 mg/m^2 on Day 1 Cycle 1 (Week 1) as IV infusion for 2 hours, and then at a dose of 250 mg/m^2 on Day 8 (Week 2) once weekly; followed by EMD 525797 at a target dose of 250 mg as a 1-hour IV infusion for every 2 weeks, followed by Irinotecan at a dose of 180 mg/m^2 as IV infusion for 30-90 minutes for every 2 weeks until radio-graphically documented progressive disease (PD) (as assessed by the investigator), unacceptable toxicity or eligibility for curative resection (investigator’s assessment), or withdrawal of consent.
928606|NCT01008449|B3|Baseline|Total|Total of all reporting groups
928607|NCT01008449|B2|Baseline|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928608|NCT01008449|B1|Baseline|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928609|NCT01008449|P2|Participant Flow|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928610|NCT01008449|P1|Participant Flow|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928611|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928612|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928613|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928614|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928615|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928616|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928829|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928622|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928623|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928624|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928625|NCT01008449|O2|Outcome|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928626|NCT01008449|O1|Outcome|Absorbable Subcuticular Surgical Suture|"Patients in this arm will receive absorbable subcuticular suture for wound closure of cesarean deliveries.~Absorbable Surgical Suture: Absorbable surgical suture will be used for subcuticular closure at the time of wound closure for cesarean delivery."
928627|NCT01008449|E2|Reported Event|Surgical Staples|"Patients in this arm will receive surgical staples for wound closure.~Surgical staples: Surgical staples will be used once for wound closure."
928643|NCT01007942|B2|Baseline|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928644|NCT01007942|B1|Baseline|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928645|NCT01007942|P2|Participant Flow|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928646|NCT01007942|P1|Participant Flow|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928647|NCT01007942|O2|Outcome|Everolimus Placebo|Oral placebo everolimus of 5 mg/day
928648|NCT01007942|O1|Outcome|Everolimus|Oral everolimus of 5 mg/day
928649|NCT01007942|O2|Outcome|Everolimus Placebo|Oral placebo everolimus of 5 mg/day
928650|NCT01007942|O1|Outcome|Everolimus|Oral everolimus of 5 mg/day
928651|NCT01007942|O2|Outcome|Everolimus|Oral everolimus of 5 mg/day
928652|NCT01007942|O1|Outcome|Everolimus 2.5 mg|Oral everolimus of 2.5 mg/day
928653|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928654|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928655|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928656|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928657|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928658|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928659|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928660|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928661|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928662|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928663|NCT01007942|O2|Outcome|Placebo + Vinorelbine + Trastuzumab|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928664|NCT01007942|O1|Outcome|Everolimus + Vinorelbine + Trastuzumab|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928665|NCT01007942|E2|Reported Event|Placebo + Trastuzumab + Vinorelbine|Oral daily matching placebo + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928666|NCT01007942|E1|Reported Event|Everolimus + Trastuzumab + Vinorelbine|Oral everolimus (5 mg/day) + intravenous vinorelbine (25 mg/m2 weekly) + intravenous trastuzumab (2 mg/kg weekly following a 4 mg/kg loading dose on Day 1 of Cycle 1 only)
928667|NCT01007916|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects
928668|NCT01007916|P2|Participant Flow|Habitual / Lotrafilcon B|Habitual contact lenses worn first, with lotrafilcon B lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
928719|NCT01007643|P2|Participant Flow|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928669|NCT01007916|P1|Participant Flow|Lotrafilcon B / Habitual|Lotrafilcon B contact lenses worn first, with habitual contact lenses worn second. Both products worn bilaterally as often as is typical for habitual lenses, and in the same modality as is typical for habitual lenses, as prescribed by regular eye care practitioner, with extended wear not to exceed 6 nights.
928670|NCT01007916|O2|Outcome|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
928671|NCT01007916|O1|Outcome|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
928672|NCT01007916|E2|Reported Event|Habitual|Habitual soft spherical contact lens having a recommended replacement schedule of 2 weeks or monthly.
928673|NCT01007916|E1|Reported Event|Lotrafilcon B|Commercially marketed, silicone hydrogel, spherical contact lens having a recommended replacement schedule of 30 days.
928674|NCT01007838|B5|Baseline|Total|Total of all reporting groups
928675|NCT01007838|B4|Baseline|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928676|NCT01007838|B3|Baseline|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928677|NCT01007838|B2|Baseline|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928900|NCT01006980|B3|Baseline|Total|Total of all reporting groups
928678|NCT01007838|B1|Baseline|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928679|NCT01007838|P4|Participant Flow|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928680|NCT01007838|P3|Participant Flow|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928681|NCT01007838|P2|Participant Flow|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928682|NCT01007838|P1|Participant Flow|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928683|NCT01007838|O4|Outcome|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928684|NCT01007838|O3|Outcome|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928685|NCT01007838|O2|Outcome|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928686|NCT01007838|O1|Outcome|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928687|NCT01007838|E4|Reported Event|Healthy Controls Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928688|NCT01007838|E3|Reported Event|Healthy Controls Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928689|NCT01007838|E2|Reported Event|Chronic Kidney Disease Sham Exercise Group|Lower body stretching exercise using the easiest rehabilitation elastic Theraband
928690|NCT01007838|E1|Reported Event|Chronic Kidney Disease Progressive Resistance Training Group|Progressive resistance training programme using a dialysis specific fitness machine: 80 % of predicted one repetition max, weight lifted will be increased when three sets of ten repetitions can be completed without failure.
928691|NCT01007812|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
928692|NCT01007812|P2|Participant Flow|Comfilcon A / Lotrafilcon B|Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week, followed by Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
928693|NCT01007812|P1|Participant Flow|Lotrafilcon B / Comfilcon A|Lotrafilcon B silicone hydrogel, toric, soft contact lenses worn for one week, followed by Comfilcon A silicone hydrogel, toric, soft contact lenses worn for one week. Both products worn in a daily wear modality.
928694|NCT01007812|O2|Outcome|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
928695|NCT01007812|O1|Outcome|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
928696|NCT01007812|E2|Reported Event|Comfilcon A Contact Lens|Silicone hydrogel, toric, soft contact lens
928697|NCT01007812|E1|Reported Event|Lotrafilcon B Contact Lens|Silicone hydrogel, toric, soft contact lens
928698|NCT01007656|B1|Baseline|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928699|NCT01007656|P1|Participant Flow|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928747|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
929586|NCT01005251|B1|Baseline|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
928700|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928701|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928702|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928703|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928704|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
929126|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
928705|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928706|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928707|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928708|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928709|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928710|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928711|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928712|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928713|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928714|NCT01007656|O1|Outcome|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928715|NCT01007656|E1|Reported Event|GD Antrodia Camphorata|"GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124)."
928716|NCT01007643|B3|Baseline|Total|Total of all reporting groups
928717|NCT01007643|B2|Baseline|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928718|NCT01007643|B1|Baseline|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928720|NCT01007643|P1|Participant Flow|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928721|NCT01007643|O2|Outcome|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928722|NCT01007643|O1|Outcome|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928723|NCT01007643|E2|Reported Event|Traditional Exercise Program|Exercise programs involved exercises focusing on VMO strength and hamstring and quadriceps stretching. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928724|NCT01007643|E1|Reported Event|Wii Fit (TM) Interactive Video Game|Exercise program involved exercises focusing on VMO strength and hamstring and quadriceps stretching utilizing the Wii Fit (TM) Interactive Video Game. Exercises were to be done on a daily basis for 12 weeks and recorded on the provided exercise calendar.
928725|NCT01007552|B1|Baseline|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928726|NCT01007552|P1|Participant Flow|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928727|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928728|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928729|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928730|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928731|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928732|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928733|NCT01007552|O1|Outcome|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928734|NCT01007552|E1|Reported Event|Gemcitabine, Capecitabine and Bevacizumab|"Estimate the toxicity of the regimen, and estimate the quality of life (QOL).~Gemcitabine, Capecitabine and Bevacizumab: Bevacizumab 15 mg/ kg every 3 weeks, starting day 1; Capecitabine 650 mg/m2 bid x 14 days starting day 1, Gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated every 21 days."
928735|NCT01007435|B5|Baseline|Total|Total of all reporting groups
928736|NCT01007435|B4|Baseline|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928737|NCT01007435|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928738|NCT01007435|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928739|NCT01007435|B1|Baseline|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928740|NCT01007435|P4|Participant Flow|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928741|NCT01007435|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928742|NCT01007435|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928743|NCT01007435|P1|Participant Flow|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928744|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928745|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928746|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928748|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928749|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928750|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928751|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928752|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928753|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928754|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928755|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928756|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928757|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928758|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928759|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928760|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928761|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928762|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928763|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928764|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928765|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928766|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928767|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928768|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928769|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928770|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928771|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928772|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928773|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928774|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928775|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928776|NCT01007435|O4|Outcome|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928777|NCT01007435|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928778|NCT01007435|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928779|NCT01007435|O1|Outcome|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928780|NCT01007435|E4|Reported Event|Tocilizumab 8 mg/kg + Placebo to Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + placebo to methotrexate orally once a week for 104 weeks.
928781|NCT01007435|E3|Reported Event|Tocilizumab 8 mg/kg + Methotrexate|Patients received tocilizumab 8 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928782|NCT01007435|E2|Reported Event|Tocilizumab 4 mg/kg + Methotrexate|Patients received tocilizumab 4 mg/kg iv every 4 weeks + methotrexate orally once a week for 104 weeks.
928783|NCT01007435|E1|Reported Event|Placebo to Tocilizumab + Methotrexate|Patients received placebo tocilizumab intravenously (iv) every 4 weeks + methotrexate orally once a week for 104 weeks.
928784|NCT01007396|B1|Baseline|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
928828|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
929587|NCT01005251|P5|Participant Flow|Placebo|PPI+Placebo
928785|NCT01007396|P1|Participant Flow|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
928786|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
928787|NCT01007396|O1|Outcome|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
928788|NCT01007396|E1|Reported Event|New Healthcare Workers|"a baseline 1-step tuberculin skin test (TST) and baseline QuantiFERON-TB Gold In-Tube test were performed in the new healthcare workers.~After oner year, serial QFT-IT testing was performed for all participants, except for those who had left the hospital."
928789|NCT01007253|B1|Baseline|Entire Study Population|Includes groups randomized to receive PL/PL first, FF/PL first, PL/OLO first, and FF/OLO first.
928790|NCT01007253|P4|Participant Flow|PL/PL, FF/PL, PL/OLO, FF/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL),~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO), and~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO)."
930119|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
928791|NCT01007253|P3|Participant Flow|FF/OLO, PL/PL, FF/PL, PL/OLO|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL),~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL), and~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO)."
928792|NCT01007253|P2|Participant Flow|PL/OLO, FF/OLO, PL/PL, FF/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO),~placebo (PL) nasal spray and PL eye drops (PL/PL), and~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)."
928793|NCT01007253|P1|Participant Flow|FF/PL, PL/OLO, FF/OLO, PL/PL|"Each subject received a total of 4 weeks of treatment (1 week per treatment with 2 week washout period between treatments) in the following order:~fluticasone furoate (FF) nasal spray and PL eye drops (FF/PL)~PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (PL/OLO),~FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution (FF/OLO), and~placebo (PL) nasal spray and PL eye drops (PL/PL)."
928794|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928795|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928796|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
928797|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
928798|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928799|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928800|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
928801|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
928802|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928803|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928804|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
928805|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
928806|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928807|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928808|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
928809|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
928810|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928811|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928812|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
928813|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
928814|NCT01007253|O4|Outcome|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928815|NCT01007253|O3|Outcome|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928816|NCT01007253|O2|Outcome|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
928817|NCT01007253|O1|Outcome|PL/PL|placebo (PL) nasal spray and PL eye drops
928818|NCT01007253|E4|Reported Event|FF/OLO|FF nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928819|NCT01007253|E3|Reported Event|PL/OLO|PL nasal spray and olopatadine (OLO) 0.2% ophthalmic solution
928820|NCT01007253|E2|Reported Event|FF/PL|fluticasone furoate (FF) nasal spray and PL eye drops
928821|NCT01007253|E1|Reported Event|PL/PL|placebo (PL) nasal spray and PL eye drops
928822|NCT01007149|B3|Baseline|Total|Total of all reporting groups
928823|NCT01007149|B2|Baseline|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928824|NCT01007149|B1|Baseline|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928825|NCT01007149|P2|Participant Flow|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928826|NCT01007149|P1|Participant Flow|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928827|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928830|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928831|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928832|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928833|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928834|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928835|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928836|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928837|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928838|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
930120|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
928839|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928840|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928841|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928842|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928843|NCT01007149|O2|Outcome|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928844|NCT01007149|O1|Outcome|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928845|NCT01007149|E2|Reported Event|Placebo|Participants received subcutaneous injections of placebo to omalizumab every 2 weeks or every 4 weeks.
928846|NCT01007149|E1|Reported Event|Omalizumab|Participants received subcutaneous injections of omalizumab every 2 weeks or every 4 weeks; dosage dependent on IgE level and body weight.
928847|NCT01007123|B5|Baseline|Total|Total of all reporting groups
928848|NCT01007123|B4|Baseline|Placebo|Administered once daily for the duration of the study
928849|NCT01007123|B3|Baseline|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928850|NCT01007123|B2|Baseline|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928851|NCT01007123|B1|Baseline|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928852|NCT01007123|P4|Participant Flow|Placebo|Administered once daily for the duration of the study
928853|NCT01007123|P3|Participant Flow|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928854|NCT01007123|P2|Participant Flow|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928855|NCT01007123|P1|Participant Flow|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928856|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
928857|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928858|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928859|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928860|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928861|NCT01007123|O2|Outcome|Eobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928862|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928863|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
928864|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928865|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928866|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928867|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
928868|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928869|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928870|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928871|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
928872|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928873|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928874|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928875|NCT01007123|O4|Outcome|Placebo|Administered once daily for the duration of the study
928876|NCT01007123|O3|Outcome|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928877|NCT01007123|O2|Outcome|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928878|NCT01007123|O1|Outcome|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928879|NCT01007123|E4|Reported Event|Placebo|Administered once daily for the duration of the study
928880|NCT01007123|E3|Reported Event|Elobixibat (A3309) 15 mg|Administered once daily for the duration of the study
928881|NCT01007123|E2|Reported Event|Elobixibat (A3309) 10 mg|Administered once daily for the duration of the study.
928882|NCT01007123|E1|Reported Event|Elobixibat (A3309) 5 mg|Administered once daily for the duration of the study
928883|NCT01007110|B3|Baseline|Total|Total of all reporting groups
928884|NCT01007110|B2|Baseline|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
928885|NCT01007110|B1|Baseline|Placebo|soy/corn oil placebo
928886|NCT01007110|P2|Participant Flow|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
928887|NCT01007110|P1|Participant Flow|Placebo|soy/corn oil placebo
928888|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
928889|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
928890|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
928891|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
928892|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
928893|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
928894|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid
928895|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
928896|NCT01007110|O2|Outcome|Docosahexaenoic Acid (DHA)|600 mg/day docosahexaenoic acid (DHA)
928897|NCT01007110|O1|Outcome|Placebo|soy/corn oil placebo
928898|NCT01007110|E2|Reported Event|Docosahexaenoic Acid (DHA)|600 mg Docosahexaenoic Acid (DHA)
928901|NCT01006980|B2|Baseline|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928902|NCT01006980|B1|Baseline|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928903|NCT01006980|P2|Participant Flow|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928904|NCT01006980|P1|Participant Flow|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928905|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928906|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928907|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928908|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928909|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928910|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928911|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928912|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928913|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928914|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928915|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928916|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928917|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928918|NCT01006980|O2|Outcome|Dacarbazine|Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length).
928919|NCT01006980|O1|Outcome|Vemurafenib|Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg).
928920|NCT01006980|E3|Reported Event|Vemurafenib After Crossover|Adverse events reported for this group include those occurring following switch to vemurafenib in those participants who switched from dacarbazine to vemurafenib during the study.
928921|NCT01006980|E2|Reported Event|Dacarbazine|"Adverse events reported for this group include those occurring in participants receiving dacarbazine starting at their baseline visit until study discontinuation or treatment switch.~Dacarbazine was administered intravenously 1000 mg/m˄2 up to 60 minutes on Day 1 of every 3 weeks (3 weeks was one cycle length)."
928922|NCT01006980|E1|Reported Event|Vemurafenib|"Adverse events reported for this group include those occurring in participants receiving vemurafenib starting at their baseline visit.~Participants received continuous oral doses of vemurafenib (RO5185426) 960 mg twice a day. Participants took four 240 mg tablets in the morning and four 240 mg tablets in the evening (960 mg twice a day for a total daily dose of 1920 mg)."
928947|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928923|NCT01006889|B1|Baseline|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
928924|NCT01006889|P1|Participant Flow|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
928925|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
928926|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
929127|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
928927|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
928928|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
928929|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
928930|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
928931|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|Patients with T2DM well controlled with bedtime insulin alone (n=5), or bedtime insulin and premeal rapid-acting insulin novolog (n=15), for the previous 6 months were treated with exenatide twice daily for 6 months (if on premeal insulin it was stopped).
928932|NCT01006889|O1|Outcome|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
928933|NCT01006889|E1|Reported Event|Exenatide (Twice Daily)|The participants with T2DM well-controlled on an intensified insulin regimen for the previous 6 months with the combination of a premeal insulin injection of the drug aspart (Novolog) three times a day and a bedtime insulin injection of the drug detemir (Levemir). The dosage of the insulin is determined by the need by the need of the participant. The Exenatide treatment will consist of an injection of the insulin twice daily and will replace the premeal insulin regiment of aspart.
928934|NCT01006655|B3|Baseline|Total|Total of all reporting groups
928935|NCT01006655|B2|Baseline|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
928936|NCT01006655|B1|Baseline|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
928937|NCT01006655|P2|Participant Flow|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
928938|NCT01006655|P1|Participant Flow|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
928939|NCT01006655|O2|Outcome|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
928940|NCT01006655|O1|Outcome|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
928941|NCT01006655|E2|Reported Event|Qvar First, Adenosine Challenge Test|10 controlled or partially controlled multiple trigger wheezing children received 4 weeks of QVAR, preceeded and succeeded by AMP challenge test, followed by an equal period of Placebo and another AMP challenge test
928942|NCT01006655|E1|Reported Event|Placebo First, Adenosine Challenge Test|11 controlled or partially controlled multiple trigger wheezing children received 4 weeks of placebo, preceeded and succeeded by AMP challenge test, followed by an equal period of QVAR and another AMP challenge test
928943|NCT01006629|B1|Baseline|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928944|NCT01006629|P1|Participant Flow|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928945|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928946|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928948|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928949|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928950|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928951|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928952|NCT01006629|O1|Outcome|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928953|NCT01006629|E1|Reported Event|Palivizumab|palivizumab 15 mg/kg intramuscularly every 30 days for 3 to 5 injections
928954|NCT01006616|B5|Baseline|Total|Total of all reporting groups
928955|NCT01006616|B4|Baseline|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928956|NCT01006616|B3|Baseline|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928957|NCT01006616|B2|Baseline|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928958|NCT01006616|B1|Baseline|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929128|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
928959|NCT01006616|P4|Participant Flow|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928960|NCT01006616|P3|Participant Flow|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928961|NCT01006616|P2|Participant Flow|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928962|NCT01006616|P1|Participant Flow|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally once daily (QD) for up to 2 years
928963|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928964|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928965|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928966|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928967|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928968|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928969|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928970|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928971|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928972|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928973|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928974|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928975|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928976|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928977|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928978|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928979|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928980|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928981|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928982|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928983|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928984|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928985|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928986|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928987|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928988|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928989|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928990|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928991|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928992|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928993|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928994|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928995|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
928996|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
928997|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928998|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
928999|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929000|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929001|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929002|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929003|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929004|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929005|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929006|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929007|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929008|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929009|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929010|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929011|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929012|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929013|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929014|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929015|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929016|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929017|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929018|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929019|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929020|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929021|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929022|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929023|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929024|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929025|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929026|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929027|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929588|NCT01005251|P4|Participant Flow|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
929028|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929029|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929030|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929031|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929032|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929033|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929034|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929035|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929036|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
930121|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
929037|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929038|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929039|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929040|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929041|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929042|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929043|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929044|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929045|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929046|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929047|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929048|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929049|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929050|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929051|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929052|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929053|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929054|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929055|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929056|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929057|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929058|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929059|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929060|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929061|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929062|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929063|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929064|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929065|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929110|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929066|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929067|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929068|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929069|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929070|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929071|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929072|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929073|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929074|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929075|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
930122|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
929076|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929077|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929078|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929079|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929080|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929081|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929082|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929083|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929084|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929085|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929086|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929087|NCT01006616|O4|Outcome|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929088|NCT01006616|O3|Outcome|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929089|NCT01006616|O2|Outcome|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929090|NCT01006616|O1|Outcome|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929091|NCT01006616|E4|Reported Event|Placebo|Participants receive placebo to navarixin, as three placebo capsules, administered orally QD for up to 2 years
929092|NCT01006616|E3|Reported Event|Navarixin 50 mg|Participants receive navarixin 50 mg, as two navarixin 10 mg capsules and one navarixin 30 mg capsule, administered orally QD for up to 2 years
929093|NCT01006616|E2|Reported Event|Navarixin 30 mg|Participants receive navarixin 30 mg, as one navarixin 30 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929094|NCT01006616|E1|Reported Event|Navarixin 10 mg|Participants receive navarixin 10 mg, as one navarixin 10 mg capsule and two placebo capsules, administered orally QD for up to 2 years
929095|NCT01006603|B3|Baseline|Total|Total of all reporting groups
929096|NCT01006603|B2|Baseline|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929097|NCT01006603|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929098|NCT01006603|P2|Participant Flow|Glimepiride 1 - 6 mg|Glimepiride : 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929099|NCT01006603|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929100|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929101|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929102|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929103|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929104|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929105|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929106|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929107|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929108|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929109|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
938576|NCT00984308|O1|Outcome|Intervention|
929112|NCT01006603|O2|Outcome|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929113|NCT01006603|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929114|NCT01006603|E2|Reported Event|Glimepiride 1 - 6 mg|Glimepiride 1, 2, 3, 4 or 6 mg, oral encapsulated tablet, once daily
929115|NCT01006603|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg, oral tablet, once daily
929116|NCT01006590|B3|Baseline|Total|Total of all reporting groups
929117|NCT01006590|B2|Baseline|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929118|NCT01006590|B1|Baseline|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
929119|NCT01006590|P2|Participant Flow|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929120|NCT01006590|P1|Participant Flow|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
929121|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929122|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
929123|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929124|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
929125|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929129|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929130|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
929131|NCT01006590|O2|Outcome|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929132|NCT01006590|O1|Outcome|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
929133|NCT01006590|E2|Reported Event|Metformin Uptitration|Metformin uptitration, 500-1000 mg daily , add-on to Metformin 1500 mg/day
929134|NCT01006590|E1|Reported Event|Saxagliptin|Saxagliptin, 5 mg once daily add-on to Metformin 1500 mg/day
929135|NCT01006356|B1|Baseline|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929136|NCT01006356|P1|Participant Flow|Hydromorphone Hydrochloride Oral Osmotic System|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929137|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929138|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929139|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929140|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929141|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929142|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929143|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929144|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929145|NCT01006356|O1|Outcome|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929146|NCT01006356|E1|Reported Event|Hydromorphone HCl OROS|Hydromorphone HCl OROS administered at a dose of 8 milligram once daily for 2 weeks.
929147|NCT01006291|B4|Baseline|Total|Total of all reporting groups
929148|NCT01006291|B3|Baseline|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
929149|NCT01006291|B2|Baseline|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
929150|NCT01006291|B1|Baseline|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
929151|NCT01006291|P3|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
929152|NCT01006291|P2|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
929153|NCT01006291|P1|Participant Flow|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
929154|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
929155|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
929156|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
929157|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
929158|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
929159|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
929589|NCT01005251|P3|Participant Flow|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
929160|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
929161|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
929162|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
929163|NCT01006291|O3|Outcome|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
929164|NCT01006291|O2|Outcome|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
929165|NCT01006291|O1|Outcome|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
929166|NCT01006291|E3|Reported Event|IGlar OD|Insulin glargine (IGlar) was given once daily (OD) subcutaneously (s.c.) according to local labelling with or without pre-trial OADs for 26 weeks.
929167|NCT01006291|E2|Reported Event|IDeg OD|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) at main evening meal with or without pre-trial OADs for 26 weeks.
951254|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
929168|NCT01006291|E1|Reported Event|IDeg OD FF|Insulin degludec (IDeg) was given once daily (OD) subcutaneously (s.c.) with or without pre-trial OADs for 26 weeks with alternating morning and evening dosing according to a fixed flexible (FF) schedule (approximately 8-40 hours intervals between doses).
929169|NCT01006135|B1|Baseline|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
929170|NCT01006135|P1|Participant Flow|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
929171|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
929172|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
929173|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
929174|NCT01006135|O1|Outcome|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
929175|NCT01006135|E1|Reported Event|Patients Treated With Spiriva|Treatment with 18 mcg tiotropium inhalation capsules of Spiriva
929176|NCT01006122|B1|Baseline|Entire Study|Included all participants randomized to receive PF-03654746 first and placebo first.
929177|NCT01006122|P2|Participant Flow|Placebo First Then, PF-03654746|Placebo matched to PF-03654746 orally once daily as PIC in the first DB intervention period then PF-03654746 at a starting dose of 0.25 mg to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as PIC in the TP at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week SP at fixed dose stabilized in the TP in the second DB intervention. A washout period of at least 7 days was maintained between each treatment period.
929178|NCT01006122|P1|Participant Flow|PF-03654746 First, Then Placebo|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in the first double-blind (DB) intervention period then placebo matched to PF-03654746 orally once daily as PIC in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
929179|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929180|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929181|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929182|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929183|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929184|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929185|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929186|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929187|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929188|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929189|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929190|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929191|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929192|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929193|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929194|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929195|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929196|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929197|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929198|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929199|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929200|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929201|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929202|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929203|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929204|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929205|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929206|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929207|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929208|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929209|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929210|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929211|NCT01006122|O2|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929212|NCT01006122|O1|Outcome|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929213|NCT01006122|E2|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily as PIC in the first or second DB intervention periods.
929301|NCT01005888|B1|Baseline|C1INH-nf First, Then Placebo|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
929214|NCT01006122|E1|Reported Event|PF-03654746|PF-03654746 at a starting dose of 0.25 milligram (mg) to maximum dose of 2 mg, depending upon the safety and tolerability, given orally once daily as powder in a capsule (PIC) in the titration phase (TP) at 5 days interval up to 15 to 25 days, depending on dose toleration followed by a 3-week stable dose phase (SP) at fixed dose stabilized in the TP in first or second DB intervention periods.
929215|NCT01006018|B4|Baseline|Total|Total of all reporting groups
929216|NCT01006018|B3|Baseline|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
929217|NCT01006018|B2|Baseline|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
929218|NCT01006018|B1|Baseline|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
929219|NCT01006018|P3|Participant Flow|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
929220|NCT01006018|P2|Participant Flow|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
929221|NCT01006018|P1|Participant Flow|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
929222|NCT01006018|O3|Outcome|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
929223|NCT01006018|O2|Outcome|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
929224|NCT01006018|O1|Outcome|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
929225|NCT01006018|E3|Reported Event|PLACEBO|"Sitagliptin (DPP-IV inhibitor) PLACEBO daily by mouth~+ pioglitazone (TZD) PLACEBO daily by mouth"
929226|NCT01006018|E2|Reported Event|Sitagliptin + Pioglitazone|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone (TZD) 15 mg daily by mouth"
929227|NCT01006018|E1|Reported Event|Sitagliptin + Pioglitazone PLACEBO|"Sitagliptin (DPP-IV inhibitor) 100 mg daily by mouth~+ pioglitazone PLACEBO daily by mouth"
929228|NCT01005966|B1|Baseline|All Randomized Participants|All randomized participants who received at least one dose of the study treatments or who have been evaluated for AEs were included.
929229|NCT01005966|P5|Participant Flow|Placebo Toothpaste (0ppmF)|Placebo fluoride free toothpaste
929230|NCT01005966|P4|Participant Flow|NaF Toothpaste (675ppmF)|Study toothpaste containing sodium fluoride and silica (675ppmF as NaF)
929231|NCT01005966|P3|Participant Flow|Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)|Reference toothpaste containing sodium monofluorophosphate and sodium fluoride (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
929232|NCT01005966|P2|Participant Flow|Amine Fluoride(AmF) Toothpaste (1400ppmF)|Reference toothpaste containing amine fluoride (1400ppm fluoride as AmF)
929233|NCT01005966|P1|Participant Flow|Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F]|Study toothpaste containing sodium fluoride/ silica (1426ppm fluoride as NaF)
929234|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo: Fluoride free toothpaste
929235|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
929236|NCT01005966|O3|Outcome|Na MFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
929237|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
929238|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
929239|NCT01005966|O5|Outcome|Placebo Toothpaste (0ppmF)|Placebo - fluoride free toothpaste
929240|NCT01005966|O4|Outcome|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/silica (675ppmF)
929241|NCT01005966|O3|Outcome|NaMFP/NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/NaF (1450ppmF– 1000ppmF as NaMFP and 450ppmF as NaF)
929242|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF(1400ppmF)
929243|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
929244|NCT01005966|O2|Outcome|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
929245|NCT01005966|O1|Outcome|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
929246|NCT01005966|E6|Reported Event|Overall|
929247|NCT01005966|E5|Reported Event|Placebo Toothpaste (0ppmF)|Placebo: fluoride free toothpaste
929248|NCT01005966|E4|Reported Event|NaF Toothpaste (675ppmF)|Toothpaste containing NaF/ silica (675ppmF)
929249|NCT01005966|E3|Reported Event|NaMFP/ NaF Toothpaste (1450ppmF)|Reference toothpaste containing NaMFP/ NaF (1450ppmF – 1000ppmF as NaMFP and 450ppmF as NaF)
929250|NCT01005966|E2|Reported Event|AmF Toothpaste (1400ppmF)|Reference toothpaste containing AmF (1400ppmF)
929251|NCT01005966|E1|Reported Event|NaF Toothpaste (1426ppmF)|Study toothpaste containing NaF/ silica (1426ppmF)
929252|NCT01005914|B1|Baseline|Group 1|"Drug:cyclophosphamide Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily~Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
929272|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929273|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929590|NCT01005251|P2|Participant Flow|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
929253|NCT01005914|P1|Participant Flow|Group 1|"Drug:cyclophosphamide-Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3 Drug:cytarabine Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4 Drug:dexamethasone Day 1-4; 11-14: 40 mg daily Drug:doxorubicin hydrochloride Day 4: 50 mg/m2 IV over 2 hours Drug:imatinib mesylate 600 mg/day Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion Drug: methylprednisolone Day 1-3: 50mg IV BID Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
929254|NCT01005914|O1|Outcome|Group 1|Cy D1- 3: 300 m g/m2 IV- 6 doses, mesna 600 mg/ m2 /day continuous IV D 1-3, ARAC D 2 & 3: 3g/m2 IV q12 X 4, Dex D1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV, imatinib mesylate 600 mg/day, MTX D1: 1g/ m2 200 mg/ m2 load IV plus 800 mg/ m2, methylprednisolone D 1-3: 50mg IV BID, pegaspargase D3/D4: 2,500 IU/ m2 IV, vincristine sulfate D4 & 11: 2 mg IV, Cy: D 1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day, continuous infusion D 1-3. ARAC D 2 & 3: 3g/m2 IV q12 X 4, dex: D 1-4; 11-14: 40 mg daily, doxorubicin hydrochloride: D 4: 50 mg/m2 IV, imatinib mesylate: 600 mg/day, MTX: D 1: 1g/ m2 200 mg/ m2load IV plus 800 mg/ m2 IV, methylprednisolone: D 1-3: 50mg IV BID, pegaspargase: D 3/D4: 2,500 IU/ m2 IV, vincristine sulfate: D 4 & 11: 2 mg IV, pharmacological study: C1A: pre-dose between Days 1 to 4, C1A: D11 or 12., C1A: D18 or 19, C 1A: D25 or 26, C1A: D32 or 33 C1B: pre-dose between D1-3, C1B: D1 or 11 C1B: D17 or 18, C1B: D24 or 25 C1B: D31 or 32
929255|NCT01005914|E1|Reported Event|Group 1|"cyclophosphamide D1- 3: 300 m g/m2 IV 6 doses plus mesna 600 mg/ m2 /day cont. IV D1-3, cytarabine D2 & 3: 3g/m2 IV, dexD1-4; 11-14: 40 mg daily, doxorubicin hydrochloride D4: 50 mg/m2 IV~Drug:imatinib mesylate 600 mg/day~Drug:methotrexate Day 1: 1g/ m2 (200 mg/ m2load IV over 2 hours plus 800 mg/ m2 over 22 hours as an infusion~Drug: methylprednisolone Day 1-3: 50mg IV BID~Drug: pegaspargase Day 3/Day4: 2,500 IU/ m2 IV~Drug: vincristine sulfate Day 4 & 11: 2 mg IV~cyclophosphamide: Day 1- 3: 300 m g/m2 IV over 2-3 hours every 12 hours for 6 doses plus mesna 600 mg/ m2 /day continuous infusion Days 1-3~cytarabine: Day 2 & 3: 3g/m2 IV over 2 hours q12 X 4~dexamethasone: Day 1-4; 11-14: 40 mg daily~doxorubicin hydrochloride: Day 4: 50 mg/m2 IV over 2 hours~imatinib mesylate: 600 mg/day~methotrexate: D"
929256|NCT01005901|B3|Baseline|Total|Total of all reporting groups
951255|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
929257|NCT01005901|B2|Baseline|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929258|NCT01005901|B1|Baseline|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929259|NCT01005901|P2|Participant Flow|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929260|NCT01005901|P1|Participant Flow|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929261|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929262|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929263|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929264|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929265|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929266|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929267|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929268|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929269|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929270|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929271|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929300|NCT01005888|B2|Baseline|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
929274|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929275|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929276|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929277|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929278|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929279|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929280|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929281|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929314|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
951256|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
929282|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929283|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929284|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929285|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929286|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929287|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929288|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929289|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929290|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929291|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929292|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929293|NCT01005901|O2|Outcome|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929294|NCT01005901|O1|Outcome|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929295|NCT01005901|E2|Reported Event|Placebo|Placebo delivered once daily via SDDPI. At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929296|NCT01005901|E1|Reported Event|Glycopyrronium Bromide|Glycopyrronium bromide 50µg delivered once daily via Single Dose Dry Powder Inhaler (SDDPI). At Visit 1 all patients were provided with a short acting β2-agonist (salbutamol/albuterol) which they were instructed to use throughout the study as rescue medication.
929297|NCT01005888|B5|Baseline|Total|Total of all reporting groups
929298|NCT01005888|B4|Baseline|Randomized, Not Treated|One subject was randomized but withdrew prior to receiving study drug.
929299|NCT01005888|B3|Baseline|Open-label C1INH-nf Only|One subject received open-label C1INH-nf but withdrew prior to randomization.
929591|NCT01005251|P1|Participant Flow|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
929302|NCT01005888|P2|Participant Flow|Placebo First, Then C1INH-nf|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by 1,000 U of C1INH-nf administered IV every 3 to 4 days for 12 weeks.
929303|NCT01005888|P1|Participant Flow|C1INH-nf First, Then Placebo|1,000 Units (U) of C1INH-nf administered intravenously (IV) every 3 to 4 days (approximately twice weekly) for 12 weeks, followed by matching placebo (saline) administered IV every 3 to 4 days for 12 weeks.
929304|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929305|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929306|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929307|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929308|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929309|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929310|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929311|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929312|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929313|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
930123|NCT01002742|E2|Reported Event|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
929315|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929316|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929317|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929318|NCT01005888|O2|Outcome|Placebo|Matching placebo (saline) administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929319|NCT01005888|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 4 days (approximately twice weekly) for 12 weeks.
929320|NCT01005888|E2|Reported Event|Placebo|
929321|NCT01005888|E1|Reported Event|C1INH-nf|
929322|NCT01005875|B1|Baseline|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929323|NCT01005875|P1|Participant Flow|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929324|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929325|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929326|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929327|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929328|NCT01005875|O1|Outcome|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929329|NCT01005875|E1|Reported Event|Radiation Followed by Sorafenib|"Radiation therapy, stereotactic body radiation therapy followed by Sorafenib~Sorafenib: Nexavar in bottles of 120 tables~Stereotactic Body Radiotherapy (SBRT): SBRT"
929330|NCT01005745|B1|Baseline|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
929331|NCT01005745|P1|Participant Flow|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
929375|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929376|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929332|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
929333|NCT01005745|O1|Outcome|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
929334|NCT01005745|E1|Reported Event|TIL With High Dose IL-2|"Day -7 and -6: Cyclophosphamide 60 mg/kg/day I.V. in 250 ml NS over approximately 2 hours. Mesna 20 mg/kg with D5W or NS at 125 ml/hour infused intravenously over 24 hours.~Day -5 to Day -1: Fludarabine 25 mg/m^2 intravenous piggyback (IVPB0 daily over approximately 30 minutes for 5 days.~Day 0: T cell infusion in 250-1000 ml NS over approximately 15-60 minutes depending on volume to be infused.~Days 1-5: High dose IL-2, 720,000 IU/kg IV bolus (about 15 minutes) every 8-16 hours for up to 15 doses, beginning approximately 12-16 hours after T cell infusion.~Surgery: Surgery to remove a tumor for growth of TIL~Administration of Lymphodepletion: Lymphodepleting chemotherapy with cyclophosphamide and fludarabine to enhance T cell persistence and effectiveness in vivo~Adoptive Cell Transfer: T-cell infusion~High Dose IL-2: Beginning approximately 12 - 16 hours after cell infusion."
930124|NCT01002742|E1|Reported Event|Placebo|Corticosteroids with placebo
930125|NCT01003301|B3|Baseline|Total|Total of all reporting groups
929335|NCT01005732|B1|Baseline|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
929336|NCT01005732|P1|Participant Flow|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
929337|NCT01005732|O1|Outcome|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
929338|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929339|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929340|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929341|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929342|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929343|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929344|NCT01005732|O4|Outcome|Uninjured Forearm Skin|Hardness of uninjured forearm skin is provided for comparison.
929345|NCT01005732|O3|Outcome|Kneecap|Hardness of uninjured skin over a bony prominence is provided for comparison.
929346|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929347|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929348|NCT01005732|O2|Outcome|Low Compression Zone|Low compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929349|NCT01005732|O1|Outcome|Normal/High Pressure Zone|Normal/high compression area of custom-fit compression garment applied to 1/2 of patient's wound (randomly assigned to proximal/distal)
929377|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
938577|NCT00984308|O2|Outcome|Control|
929350|NCT01005732|E1|Reported Event|Pressure Garment on Burn Wound|Pressure garment therapy was started within 2 weeks of re-epithelialization. A custom-fit pressure garment was fabricated by Medical Z Inc. (Medical Z, San Antonio, TX) and designed such that it applied pressure to only one-half of the wound, proximal or distal (according to coin toss by a consistent individual not involved in data collection for the study). The standard Lycra® 6-way stretch fabric was designed to apply 17–24 mm Hg to the normal/high compression zone and <5 mm Hg to the low compression zone. Subjects were instructed to wear the garments 23 hours per day, removing them only for bathing.
929351|NCT01005719|B1|Baseline|Overall Study|
929352|NCT01005719|P6|Participant Flow|No Treatment-Prevacid®-Zegerid|Participants received No treatment in Period 1, Prevacid® in Period 2 and Zegerid in Period 3
929353|NCT01005719|P5|Participant Flow|No Treatment-Zegerid-Prevacid®|Participants received No treatment in Period 1, Zegerid in Period 2 and Prevacid® in Period 3
929354|NCT01005719|P4|Participant Flow|Prevacid®-No Treatment-Zegerid|Participants received Prevacid® in Period 1, No treatment in Period 2 and Zegerid in Period 3
929355|NCT01005719|P3|Participant Flow|Prevacid®-Zegerid-No Treatment|Participants received Prevacid® in Period 1, Zegerid in Period 2 and No treatment in Period 3
929356|NCT01005719|P2|Participant Flow|Zegerid-No Treatment-Prevacid®|Participants received Zegerid in Period 1, No treatment in Period 2 and Prevacid® in Period 3
929357|NCT01005719|P1|Participant Flow|Zegerid-Prevacid®-No Treatment|Participants received Zegerid in Period 1, Prevacid® in Period 2 and No treatment in Period 3.
929358|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving in Prevacid® Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929359|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929360|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929361|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
930161|NCT01003184|B3|Baseline|Total|Total of all reporting groups
929362|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929363|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929364|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929365|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929366|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929367|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929368|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929369|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929370|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929371|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929372|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929373|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929374|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929577|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
929378|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929379|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929380|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929381|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929382|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929383|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929384|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929520|NCT01005316|P1|Participant Flow|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
929385|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929386|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929387|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929388|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929389|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929390|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929391|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929392|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929393|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929394|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929395|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929396|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929397|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929398|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929399|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929444|NCT01005680|E2|Reported Event|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
929400|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929401|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929402|NCT01005719|O3|Outcome|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929403|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929404|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929405|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929406|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929407|NCT01005719|O2|Outcome|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929845|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929408|NCT01005719|O1|Outcome|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929409|NCT01005719|E3|Reported Event|No Treatment|"Participants receiving No treatment in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929410|NCT01005719|E2|Reported Event|Prevacid®|"Participants receiving Prevacid® in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929411|NCT01005719|E1|Reported Event|Zegerid|"Participants receiving Zegerid in Periods 1, 2 or 3.~All participants were randomized to a 3-way crossover design and received Zegerid Capsules (20 mg omeprazole/ 1100 mg sodium bicarbonate), Prevacid Capsules (15 mg lansoprazole), or no treatment in a random order."
929412|NCT01005706|B3|Baseline|Total|Total of all reporting groups
929413|NCT01005706|B2|Baseline|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
929414|NCT01005706|B1|Baseline|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
929415|NCT01005706|P2|Participant Flow|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
929416|NCT01005706|P1|Participant Flow|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
929417|NCT01005706|O2|Outcome|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
929418|NCT01005706|O1|Outcome|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
929419|NCT01005706|E2|Reported Event|Tacrolimus Minimization Arm|"Tacrolimus dosing is based on 12-hour whole blood trough concentrations. Target blood concentration is 2-5 ng/ml.~At the time of transition patients randomized into this arm of the study will receive loading doses of Sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml."
929420|NCT01005706|E1|Reported Event|Tacrolimus Withdrawal Arm|"At the time of transition patients randomized into this arm of the study will receive loading doses of sirolimus for two days and then 5mg PO daily. Twenty-four hour troughs will be checked per the schedule to ensure and monitor the therapeutic concentrations of 8-12ng/ml.~Patients randomized into this arm of the study will continue their current dosing regimen and frequency of mycophenolate mofetil. Serum trough level monitoring of mycophenolic acid will not be performed unless clinically warranted per standard of care and dosage adjustments from such levels will be made only with consent of the study primary investigator."
929421|NCT01005680|B3|Baseline|Total|Total of all reporting groups
929422|NCT01005680|B2|Baseline|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21 day cycle, for 6 cycles"
929423|NCT01005680|B1|Baseline|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
929424|NCT01005680|P2|Participant Flow|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929425|NCT01005680|P1|Participant Flow|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929426|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929846|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929427|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929428|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929429|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929430|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929431|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929432|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929433|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929434|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929435|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929436|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929437|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929438|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929439|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929440|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929441|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929442|NCT01005680|O2|Outcome|Gemcitabine Plus Cisplatin (GC)|"Gemcitabine: 1250 mg/m² administered intravenously on Day 1 and Day 8 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929443|NCT01005680|O1|Outcome|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on Day 1 of each 21-day cycle, for 6 cycles"
929445|NCT01005680|E1|Reported Event|Pemetrexed Plus Cisplatin (PC)|"Pemetrexed: 500 milligrams/square meter (mg/m²) administered intravenously on Day 1 of each 21-day cycle, for 6 cycles~Cisplatin: 75 mg/m² administered intravenously on day 1 of each 21-day cycle, for 6 cycles"
929446|NCT01005602|B3|Baseline|Total|Total of all reporting groups
929447|NCT01005602|B2|Baseline|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
929448|NCT01005602|B1|Baseline|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
929449|NCT01005602|P2|Participant Flow|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
929450|NCT01005602|P1|Participant Flow|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
929451|NCT01005602|O4|Outcome|GA Genotype|
929452|NCT01005602|O3|Outcome|TT Genotype|
929453|NCT01005602|O2|Outcome|GT Genotype|
929454|NCT01005602|O1|Outcome|Wild Type (GG)|
929455|NCT01005602|O3|Outcome|TT Genotype|
929456|NCT01005602|O2|Outcome|CT Genotype|
929457|NCT01005602|O1|Outcome|Wild Type (CC)|
929458|NCT01005602|O3|Outcome|TT Genotype|
929459|NCT01005602|O2|Outcome|CT Genotype|
929460|NCT01005602|O1|Outcome|Wild Type|Genotypes for the ABCB1 single nucleotide polymorphism C1236T
929461|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
929462|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
929463|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
929464|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
929465|NCT01005602|O2|Outcome|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
929466|NCT01005602|O1|Outcome|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
929467|NCT01005602|E2|Reported Event|Standard Digoxin Dosing|This arm represents historical control subjects in whom the dose of digoxin was determined at the physician's discretion using traditional dosing methods.
929468|NCT01005602|E1|Reported Event|Digoxin Dosing Per Nomogram|"Subjects will have their digoxin maintenance dose determined according to the nomogram we have developed.~Dosing nomogram for digoxin: Simplified dosing nomogram for digoxin. The dose is determined by plotting a subject's creatinine clearance (x-axis) and ideal body weight (y-axis) on the nomogram. Alternatively, the dose may be determined by plotting creatinine clearance (x-axis) and gender/height (z-axis)."
929469|NCT01005355|B4|Baseline|Total|Total of all reporting groups
929470|NCT01005355|B3|Baseline|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929471|NCT01005355|B2|Baseline|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929472|NCT01005355|B1|Baseline|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929473|NCT01005355|P3|Participant Flow|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929578|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h systolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
929579|NCT01005290|E2|Reported Event|Ramipril|
929474|NCT01005355|P2|Participant Flow|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929475|NCT01005355|P1|Participant Flow|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929476|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929477|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929478|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929714|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929479|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929480|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929481|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929482|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929483|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929484|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929485|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929486|NCT01005355|O1|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929487|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929488|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929489|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929490|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929491|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929492|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929493|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929715|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
951257|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
929494|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929495|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929496|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929497|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929498|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929499|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929500|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929501|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929502|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929580|NCT01005290|E1|Reported Event|Combination Pill|
929581|NCT01005251|B6|Baseline|Total|Total of all reporting groups
929582|NCT01005251|B5|Baseline|Placebo|PPI+Placebo
929583|NCT01005251|B4|Baseline|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
929584|NCT01005251|B3|Baseline|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
929503|NCT01005355|O3|Outcome|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929504|NCT01005355|O2|Outcome|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929505|NCT01005355|O1|Outcome|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929506|NCT01005355|E3|Reported Event|IMC-1121B 10 mg/kg (Cohort 3)|"10 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 3 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929507|NCT01005355|E2|Reported Event|IMC-1121B 8 mg/kg (Cohort 2)|"8 mg/kg IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929508|NCT01005355|E1|Reported Event|IMC-1121B 6 mg/kg (Cohort 1)|"6 milligrams/kilogram (mg/kg) IMC-1121B (ramucirumab) based on participant's body weight administered intravenously over 1 hour on Day 1 every 2 weeks for 6 weeks (1 cycle).~After 1 cycle of treatment, participants who had an objective response or stable disease were permitted to receive IMC-1121B (ramucirumab) at the same dose and schedule until disease progression or unacceptable toxicity occurred, or another withdrawal criterion was met."
929716|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929509|NCT01005329|B1|Baseline|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
929510|NCT01005329|P1|Participant Flow|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV area under the curve (AUC) 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
929511|NCT01005329|O1|Outcome|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
929512|NCT01005329|E1|Reported Event|Chemoradiation (IMRT), Chemotherapy|Pelvic intensity-modulated radiation therapy (IMRT) once daily, 5 days a week, for 5 weeks (45 Gy in 25 fractions) with optional nodal boost radiotherapy and/or vaginal brachytherapy boost. Concurrent cisplatin (CISPT) 50 mg/m^2 IV over 1 hour on days 1 and 29 and bevacizumab (BEV) 5mg/kg IV over 30-90 minutes on days 1, 15, and 29. Beginning 4-6 weeks after completing IMRT, cisplatin, and bevacizumab, patients receive carboplatin (CBCDA) IV AUC 5 over 1 hour and paclitaxel (PTX) IV 135 mg/m^2 over 3 hours on day 1 and every every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
929513|NCT01005316|B4|Baseline|Total|Total of all reporting groups
929514|NCT01005316|B3|Baseline|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929573|NCT01005290|P2|Participant Flow|Combination Pill Then Ramipril|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks
929515|NCT01005316|B2|Baseline|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929516|NCT01005316|B1|Baseline|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929517|NCT01005316|P4|Participant Flow|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929518|NCT01005316|P3|Participant Flow|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929519|NCT01005316|P2|Participant Flow|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929521|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929522|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929523|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929524|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929574|NCT01005290|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg once daily
929575|NCT01005290|O2|Outcome|Ramipril|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
929576|NCT01005290|O1|Outcome|Combination Pill|Difference in the adjusted mean 24-h diastolic pressure results (using ABPM) between the basal and the final visit of each treatment period.
929525|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929526|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929527|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929528|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929529|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929626|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929844|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929530|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929531|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929532|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929533|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929534|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929535|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929536|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929537|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929538|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929627|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929914|NCT01004510|E1|Reported Event|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
929539|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929540|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929541|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929542|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929543|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929544|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929545|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929546|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929547|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929628|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
930477|NCT01001767|O1|Outcome|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
929548|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929549|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929550|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929551|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929552|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929553|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929554|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929555|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929556|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929557|NCT01005316|O1|Outcome|Enrolled|Enrolled participants who died, were transplanted or de-listed.
929558|NCT01005316|O1|Outcome|Enrolled, Not Transplanted|These participants were consented and enrolled into the study, but did not receive a heart transplant as specified by the protocol.
929662|NCT01004848|B2|Baseline|Delayed Intervention|The control group offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929559|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929560|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929561|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction),
929562|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929592|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
929563|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929564|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929565|NCT01005316|O3|Outcome|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929566|NCT01005316|O2|Outcome|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929567|NCT01005316|O1|Outcome|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929607|NCT01004991|B1|Baseline|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
929568|NCT01005316|E3|Reported Event|Cohort B: Sensitized, Crossmatch Negative|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch negativity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929569|NCT01005316|E2|Reported Event|Cohort B: Sensitized, Crossmatch Positive|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody positive as determined by Luminex(TM) LabScreen for Class I or Class II with specificities identified by single antigen testing. Retrospective cytotoxicity donor-specific crossmatch during their transplant procedure indicated crossmatch positivity. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Sensitized recipients received: induction therapy (anti-T cell antibody induction), intraoperative plasma exchange/-pheresis, short-term post-operative plasmapheresis, a post-transplant course of intravenous immunoglobulin (IVIG) therapy, maintenance corticosteroids (Prednisone), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R))
929570|NCT01005316|E1|Reported Event|Cohort A: Non-Sensitized|Participants were enrolled into the study and received a heart transplant. Immediately prior to transplant, these participants were alloantibody negative as determined by Luminex(TM) LABScreen. All administered care was clinical site standard of care. All sites followed a similar standard of care regimen. Non-sensitized recipients received steroid-free maintenance immunosuppression: induction therapy (anti-T cell antibody induction), tacrolimus (Prograf(R)), and Mycophenolate Mofetil- MMF (CellCept(R)).
929571|NCT01005290|B1|Baseline|Randomized Patiens|All patients who were randomized to both treatment sequences
929572|NCT01005290|P3|Participant Flow|Ramipril Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 5 mg ramipril for one week followed by a once daily oral dose of 10 mg ramipril for 4 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 4 weeks.
929593|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
929594|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
929595|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
929596|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
929597|NCT01005251|O5|Outcome|Placebo|PPI+Placebo
929598|NCT01005251|O4|Outcome|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
929599|NCT01005251|O3|Outcome|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
929600|NCT01005251|O2|Outcome|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
929601|NCT01005251|O1|Outcome|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
929602|NCT01005251|E5|Reported Event|Placebo|PPI+Placebo
929603|NCT01005251|E4|Reported Event|AZD3355 240 mg|PPI+AZD3355 240 mg twice daily (bid)
929604|NCT01005251|E3|Reported Event|AZD3355 180 mg|PPI+AZD3355 180 mg twice daily (bid)
929605|NCT01005251|E2|Reported Event|AZD3355 120 mg|PPI+AZD3355 120 mg twice daily (bid)
929606|NCT01005251|E1|Reported Event|AZD3355 60 mg|PPI+AZD3355 60 mg twice daily (bid)
930282|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
929608|NCT01004991|P1|Participant Flow|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
929609|NCT01004991|O1|Outcome|All Patients|"subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP~rituximab: 375 mg/m2 on Day 8 of each of 6 cycles~cyclophosphamide: 750 mg/m2 on Day 8 of each of 6 cycles~vincristine: 1.4 mg/m2 on Day 8 of each of 6 cycles~doxorubicin: 50 mg/m2 on Day 8 of each of 6 cycles~prednisone: 100 mg PO days 8-12 of each of 6 cycles~azacytidine: ﻿Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5"
929610|NCT01004991|E1|Reported Event|All Patients|all study patients
929611|NCT01004939|B1|Baseline|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929612|NCT01004939|P1|Participant Flow|Fondaparinux|Retrospective systematic documentation of female participants treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929613|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929614|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929615|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929616|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929617|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929618|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929619|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929620|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929621|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929703|NCT01004822|P8|Participant Flow|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
938578|NCT00984308|O1|Outcome|Intervention|
929622|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929623|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929624|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929625|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929712|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
951258|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
929629|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929630|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929631|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
929632|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
929633|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
929634|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
929635|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
929636|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label. Data were collected from newborns delivered by participants who received Fondaparinux during pregnancy and/or postpartum.
929637|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929638|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929639|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929640|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929831|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929641|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929642|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929643|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929644|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929645|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
930478|NCT01001767|E2|Reported Event|Placebo|Placebo capsule by mouth twice a day x 24 weeks
929646|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929647|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929648|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929649|NCT01004939|O1|Outcome|Fondaparinux|Retrospective systematic documentation of female patients treated with Fondaparinux during pregnancy and/or postpartum. The potential prophylactic dose was 1.5 or 2.5 milligrams (mg); the standard prophylactic dose was 2.5 mg. The potential therapeutic dose was 5, 7.5, or 10 mg. Higher than recommended doses could have been administered off label.
929650|NCT01004939|E2|Reported Event|Fondaparinux - Child|Events reported for children (including 4 twins) born to mothers receiving Fondaparinux
929651|NCT01004939|E1|Reported Event|Fondaparinux - Mother|Events reported for mothers receiving Fondaparinux
929652|NCT01004874|B1|Baseline|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929653|NCT01004874|P1|Participant Flow|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929654|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929655|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929656|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929677|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929657|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929658|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929659|NCT01004874|O1|Outcome|Bevacizumab, XRT, Temozolomide, Topotecan|"Bevacizumab, XRT, Temozolomide followed by Bevacizumab, Temozolomide, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Bevacizumab at 10 mg/kg every other week.~This will be followed by Bevacizumab at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929660|NCT01004874|E1|Reported Event|Avastin, XRT, Temodar Followed by Avastin, Temodar, Topotecan|"Avastin, XRT, Temodar followed by Avastin, Temodar, Topotecan : Standard radiation therapy and daily temozolomide at 75 mg/ m2 daily for 6.5 weeks of radiation in combination with Avastin at 10 mg/kg every other week.~This will be followed by Avastin at 10 mg/kg every other week, temozolomide at 150 mg/m2 daily the first 5 days in combination with topotecan at 1.5 mg/m2 (patients not taking enzyme-inducing anti-epileptic drugs) or 2.0 mg/m2 (patients taking enzyme-inducing anti-epileptic drugs) on Days 2-6 of each 28-day cycle."
929661|NCT01004848|B3|Baseline|Total|Total of all reporting groups
929663|NCT01004848|B1|Baseline|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aimed to help participants lose weight, thereby preventing their progression to diabetes."
929664|NCT01004848|P2|Participant Flow|Delayed Intervention|The control group was be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929665|NCT01004848|P1|Participant Flow|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929666|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929667|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929668|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929669|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929670|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929671|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929672|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929673|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929674|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929675|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929676|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929678|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929902|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929679|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929680|NCT01004848|O2|Outcome|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929681|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929682|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929683|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929684|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929713|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929685|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929686|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929687|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929688|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929689|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929690|NCT01004848|O2|Outcome|Delayed Intervention|The control group was offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929691|NCT01004848|O1|Outcome|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group participated in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929692|NCT01004848|E2|Reported Event|Delayed Intervention|The control group will be offered the chance to participate in the 8-session course 1 year after enrollment into the trial.
929693|NCT01004848|E1|Reported Event|Peer-Led Lifestyle Education on Weight Loss|"Project HEED (Help Educate to Eliminate Diabetes), a community-based, peer-led weight loss program for overweight adults with pre-diabetes.~The intervention group will participate in an 8-session course held over a 10-week period. Project HEED (Help Educate to Eliminate Diabetes), led by trained peer educators, aims to help participants lose weight, thereby preventing their progression to diabetes."
929694|NCT01004822|B9|Baseline|Total|Total of all reporting groups
929695|NCT01004822|B8|Baseline|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929696|NCT01004822|B7|Baseline|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929697|NCT01004822|B6|Baseline|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929698|NCT01004822|B5|Baseline|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929699|NCT01004822|B4|Baseline|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929700|NCT01004822|B3|Baseline|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929701|NCT01004822|B2|Baseline|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929702|NCT01004822|B1|Baseline|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
930057|NCT01003990|O1|Outcome|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
929704|NCT01004822|P7|Participant Flow|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929705|NCT01004822|P6|Participant Flow|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929706|NCT01004822|P5|Participant Flow|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929707|NCT01004822|P4|Participant Flow|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929708|NCT01004822|P3|Participant Flow|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929709|NCT01004822|P2|Participant Flow|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929710|NCT01004822|P1|Participant Flow|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929711|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
951259|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
929717|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929718|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929719|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929720|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929721|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929722|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929723|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929724|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929725|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929726|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929727|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929728|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929729|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929730|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929731|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929732|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929733|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929734|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929735|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929736|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929737|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
930092|NCT01002742|P1|Participant Flow|Placebo|Corticosteroids with placebo
929738|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929739|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929740|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929741|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929742|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929743|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929744|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929745|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929746|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929747|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929748|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929749|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929750|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929751|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929752|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929753|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929754|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929755|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929756|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929757|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929758|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929759|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929760|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929761|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929762|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929763|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929764|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929765|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929766|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929767|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
938579|NCT00984308|E2|Reported Event|Control|
929768|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929769|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929770|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929771|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929772|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929773|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929774|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929775|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929776|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
951260|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
929777|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929778|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929779|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929780|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929781|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929782|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929783|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929784|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929785|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929786|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929787|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929788|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929789|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929790|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929791|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929792|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929793|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929794|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929795|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929796|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929797|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929798|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929799|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929800|NCT01004822|O8|Outcome|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929801|NCT01004822|O7|Outcome|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929802|NCT01004822|O6|Outcome|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929803|NCT01004822|O5|Outcome|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929804|NCT01004822|O4|Outcome|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929805|NCT01004822|O3|Outcome|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929806|NCT01004822|O2|Outcome|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
930479|NCT01001767|E1|Reported Event|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
929807|NCT01004822|O1|Outcome|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929808|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929809|NCT01004822|O1|Outcome|All Participants|All participants who received CVX-241 (PF-05057459) 0.3, 3, 6, 12, 15, 18, 25 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in four-week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929810|NCT01004822|E8|Reported Event|CVX-241 (PF-05057459) 25 mg/kg|CVX-241 (PF-05057459) 25 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929811|NCT01004822|E7|Reported Event|CVX-241 (PF-05057459) 18 mg/kg|CVX-241 (PF-05057459) 18 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929812|NCT01004822|E6|Reported Event|CVX-241 (PF-05057459) 15 mg/kg|CVX-241 (PF-05057459) 15 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929813|NCT01004822|E5|Reported Event|CVX-241 (PF-05057459) 12 mg/kg|CVX-241 (PF-05057459) 12 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929814|NCT01004822|E4|Reported Event|CVX-241 (PF-05057459) 6 mg/kg|CVX-241 (PF-05057459) 6 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929815|NCT01004822|E3|Reported Event|CVX-241 (PF-05057459) 3 mg/kg|CVX-241 (PF-05057459) 3 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929816|NCT01004822|E2|Reported Event|CVX-241 (PF-05057459) 1 mg/kg|CVX-241 (PF-05057459) 1 mg/kg intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929817|NCT01004822|E1|Reported Event|CVX-241 (PF-05057459) 0.3 mg/kg|CVX-241 (PF-05057459) 0.3 mg/kg (milligram per kilogram) intravenous (IV) infusions once-weekly in 4 week cycles until disease progression, unacceptable toxicity, or withdrawal for other reasons.
929818|NCT01004770|B6|Baseline|Total|Total of all reporting groups
929819|NCT01004770|B5|Baseline|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929820|NCT01004770|B4|Baseline|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929821|NCT01004770|B3|Baseline|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929822|NCT01004770|B2|Baseline|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929823|NCT01004770|B1|Baseline|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929824|NCT01004770|P5|Participant Flow|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929825|NCT01004770|P4|Participant Flow|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929826|NCT01004770|P3|Participant Flow|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929827|NCT01004770|P2|Participant Flow|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929828|NCT01004770|P1|Participant Flow|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929829|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929830|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929832|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929833|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929834|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929835|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929836|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929837|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929838|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929839|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929840|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929841|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929842|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929843|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929847|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929848|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929849|NCT01004770|O5|Outcome|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929850|NCT01004770|O4|Outcome|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929851|NCT01004770|O3|Outcome|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929852|NCT01004770|O2|Outcome|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929853|NCT01004770|O1|Outcome|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929854|NCT01004770|E5|Reported Event|Visipaque Injection|Visipaque x 320mgI/mL at a dose of 450mgI/kg
929855|NCT01004770|E4|Reported Event|GE-145 Injection-900mg of Iodine/mL|GE-145 x 900 milligram (mg) Iodine (I)/mL a doses of 900mgI/kg. The subjects in each dose group only received one dose.
929856|NCT01004770|E3|Reported Event|GE-145 Injection-600mg of Iodine/mL|GE-145 x 600 milligram (mg) Iodine (I)/mL a doses of 600mgI/kg. The subjects in each dose group only received one dose.
929857|NCT01004770|E2|Reported Event|GE-145 Injection-450mg of Iodine/mL|GE-145 x 450 milligram (mg) Iodine (I)/mL a doses of 450mgI/kg. The subjects in each dose group only received one dose.
929858|NCT01004770|E1|Reported Event|GE-145 Injection-300mg of Iodine/mL|GE-145 x 300 milligram (mg) Iodine (I)/mL at doses of 300mgI/kg. The subjects in each dose group only received one dose.
929859|NCT01004705|B1|Baseline|Randomized Patients|All patients randomized to both study sequences (Combination Pill then Simvastatin and Simvastatin then Combination Pill)
929860|NCT01004705|P3|Participant Flow|Simvastatin Then Combination Pill|After randomization, in Period 1 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks.
929861|NCT01004705|P2|Participant Flow|Combination Pill Then Simvastatin|After randomization, in Period 1 participants received a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril) for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill (containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril) for 11 weeks; participants received no intervention during wash-out; in Period 2 participants received a once daily oral dose of 40 mg simvastatin for 12 weeks
929862|NCT01004705|P1|Participant Flow|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
929863|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
929864|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
929865|NCT01004705|O2|Outcome|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
929866|NCT01004705|O1|Outcome|Combination Pill|Once daily oral dose of combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks.
929867|NCT01004705|E3|Reported Event|Simvastatin|Once daily oral dose of 40 mg simvastatin for 12 weeks
929868|NCT01004705|E2|Reported Event|Combination Pill|Combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 5 mg ramipril for one week followed by a once daily oral dose of the cardiovascular fixed dose combination pill containing 100 mg acetylsalicylic acid, 40 mg simvastatin, and 10 mg ramipril for 11 weeks
929869|NCT01004705|E1|Reported Event|Pre-randomization Run-In|Screening period with ramipril 2.5 mg
929870|NCT01004614|B5|Baseline|Total|Total of all reporting groups
929871|NCT01004614|B4|Baseline|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
929872|NCT01004614|B3|Baseline|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
929873|NCT01004614|B2|Baseline|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
929874|NCT01004614|B1|Baseline|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during the second intervention period. A washout of 14 days was retained between periods.
929875|NCT01004614|P4|Participant Flow|2nd OD Tablet Without Water, Then 3rd OD Tablet Without Water|One amlodipine second generation OD 5mg tablet (reference) taken without water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken without water during the second intervention period. A washout of 14 days was retained between periods.
929915|NCT01004432|B1|Baseline|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
929876|NCT01004614|P3|Participant Flow|3rd OD Tablet Without Water, Then 2nd OD Tablet Without Water|One amlodipine third generation OD 5 mg tablet (test) taken without water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken without water during the second intervention period. A washout of 14 days was retained between periods.
929877|NCT01004614|P2|Participant Flow|2nd OD Tablet With Water, Then 3rd OD Tablet With Water|One amlodipine second generation OD 5 mg tablet (reference) taken with water during the first intervention period, then one amlodipine third generation OD 5 mg tablet (test) taken with water during the second intervention period. A washout of 14 days was retained between periods.
929878|NCT01004614|P1|Participant Flow|3rd OD Tablet With Water, Then 2nd OD Tablet With Water|One amlodipine third generation orally disintegrating (OD) 5 mg tablet (test) taken with water during the first intervention period, then one amlodipine second generation OD 5 mg tablet (reference) taken with water during second intervention period. A washout of 14 days was retained between periods.
929879|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929880|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929881|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929882|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929883|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929884|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929885|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929886|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929887|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929888|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929889|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929890|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929891|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929892|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929893|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929894|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929895|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929896|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929897|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929898|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929899|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929900|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929901|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929903|NCT01004614|O4|Outcome|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929904|NCT01004614|O3|Outcome|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929905|NCT01004614|O2|Outcome|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929906|NCT01004614|O1|Outcome|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929907|NCT01004614|E4|Reported Event|Cohort II: 2nd OD Tablet (Reference) Without Water|Cohort II: One 5 mg amlodipine 2nd OD tablet (reference) taken without water as a single oral dose
929908|NCT01004614|E3|Reported Event|Cohort II: 3rd OD Tablet (Test) Without Water|Cohort II: One 5 mg amlodipine 3rd OD tablet (test) taken without water as a single oral dose
929909|NCT01004614|E2|Reported Event|Cohort I: 2nd OD Tablet (Reference) With Water|Cohort I: One 5 mg amlodipine 2nd OD tablet (reference) taken with water as a single oral dose
929910|NCT01004614|E1|Reported Event|Cohort I: 3rd OD Tablet (Test) With Water|Cohort I: One 5 mg amlodipine 3rd OD tablet (test) taken with water as a single oral dose
929911|NCT01004510|B1|Baseline|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
929912|NCT01004510|P1|Participant Flow|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy. Zoledronic acid dose per package insert for up to 4 cycles.
929913|NCT01004510|O1|Outcome|Zoledronic Acid|Monthly zoledronic acid in addition to chemotherapy
929916|NCT01004432|P5|Participant Flow|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
929917|NCT01004432|P4|Participant Flow|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
929918|NCT01004432|P3|Participant Flow|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
929919|NCT01004432|P2|Participant Flow|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
929920|NCT01004432|P1|Participant Flow|Open-label (OL) Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
929921|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
929922|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
929923|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
929924|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
929925|NCT01004432|O4|Outcome|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
929926|NCT01004432|O3|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
929927|NCT01004432|O2|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
929928|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
929929|NCT01004432|O2|Outcome|DB Group 2b: Golimumab 2 mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
929930|NCT01004432|O1|Outcome|DB Group 2a: Golimumab 50 mg SC & Placebo IV + MTX|Participants, who did not achieved DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
929931|NCT01004432|O1|Outcome|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
929932|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
929933|NCT01004432|O1|Outcome|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
929934|NCT01004432|E5|Reported Event|OL Study Extension Group: Golimumab 50 mg SC + MTX|Participants who completed the main study (Week 0 to Week 52), not met lack of efficacy criteria, and participated in the OL study extension, received golimumab 50 mg SC injection every 4 weeks + MTX from Week 52 to Week 72.
929935|NCT01004432|E4|Reported Event|DB Group 2b: Golimumab 2mg/kg IV & Placebo SC + MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 2 milligram per kilogram (mg/kg) intravenous infusion (IV) + MTX, at Week 16, 20, 28, 36 and 44, along with placebo matched to golimumab SC injection every 4 weeks from Week 16 to Week 48.
929936|NCT01004432|E3|Reported Event|Double Blind (DB) Group 2a: Golimumab 50mg SC & Placebo IV+MTX|Participants, who did not achieve DAS28 good response at Week 16, were randomly assigned to receive golimumab 50 mg SC injection every 4 weeks + MTX from Week 16 to Week 48, along with placebo matched to golimumab intravenous infusion (IV) at Week 16, 20, 28, 36, and 44.
929937|NCT01004432|E2|Reported Event|OL Group 1: Golimumab 50 mg SC + MTX|Participants, who achieved Disease Activity Score in 28 joints (DAS28) good response at Week 16, received Golimumab 50 milligram (mg) subcutaneous (SC) injection every 4 weeks + Methotrexate (MTX) from Week 16 to Week 48.
929938|NCT01004432|E1|Reported Event|OL Overall Group: Golimumab 50 mg SC + MTX|All enrolled and dosed participants received golimumab 50 mg SC injection every 4 weeks + MTX from Week 0 to Week 12.
930480|NCT01001702|B1|Baseline|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
929939|NCT01004393|B1|Baseline|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929940|NCT01004393|P1|Participant Flow|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929941|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929942|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929943|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929944|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929945|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929946|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929947|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929948|NCT01004393|O1|Outcome|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929949|NCT01004393|E1|Reported Event|Methylnaltrexone|Methylnaltrexone bromide: Methylnaltrexone bromide, dosage based on weight (0.15 mg/kg (round dose up to nearest 0.1 mL of volume) for weight less than 38 kg or greater than 114 kg; 8 mg (0.4 mL) for weight 38 kg to less than 62 kg; and 12 mg (0.6 mL) for weight 62 kg to 114 kg), single dose
929950|NCT01004354|B1|Baseline|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
929951|NCT01004354|P1|Participant Flow|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
929952|NCT01004354|O1|Outcome|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
929953|NCT01004354|E1|Reported Event|Vitamin D|This was an open label trial that consisted of one interventional arm involving the administration of 2000 international units of ergocalciferol daily for 8 weeks.
929954|NCT01004263|B1|Baseline|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
929955|NCT01004263|P1|Participant Flow|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
930093|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930094|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
929956|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
929957|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
929958|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
929959|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
929960|NCT01004263|O1|Outcome|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
929961|NCT01004263|E1|Reported Event|Rizatriptan|Participants self-administered rizatriptan to treat up to 8 qualifying migraine headaches (mild, moderate, or severe pain intensity) per month, for up to 12 months. Rizatriptan dose, administered as a single oral tablet, was either 5 or 10 mg, based on participant weight (5 mg if <40 kg, 10 mg if ≥40 kg).
929962|NCT01004250|B1|Baseline|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929963|NCT01004250|P1|Participant Flow|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 milligram per kilogram (mg/kg) given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 milligram per square meter (mg/m²) given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle (cycle=21 days) and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929964|NCT01004250|O1|Outcome|Study Treament|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929965|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
929966|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929967|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929968|NCT01004250|O1|Outcome|Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929969|NCT01004250|E3|Reported Event|Overall Study Treatment|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles.~Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929970|NCT01004250|E2|Reported Event|Maintenance Therapy|"Maintenance Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity.~Pemetrexed: 500 mg/m² given intravenously on Day 1 of each cycle and continued until progression or unacceptable toxicity."
929971|NCT01004250|E1|Reported Event|Induction Therapy|"Induction Therapy:~Bevacizumab: 7.5 mg/kg given intravenously on Day 1 for four cycles (cycle=21 days) of Induction Therapy.~Pemetrexed: 500 mg/m² given intravenously on Day 1 for four cycles of Induction Therapy.~Cisplatin: 75 mg/m² given intravenously on Day 1 for a maximum of 4 cycles."
929972|NCT01004185|B3|Baseline|Total|Total of all reporting groups
930095|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
929973|NCT01004185|B2|Baseline|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
929974|NCT01004185|B1|Baseline|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
929975|NCT01004185|P2|Participant Flow|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
929976|NCT01004185|P1|Participant Flow|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
929977|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
929978|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
929979|NCT01004185|O2|Outcome|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
929980|NCT01004185|O1|Outcome|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
929981|NCT01004185|E2|Reported Event|Low Dose|Subjects who weigh 17-<33 kg will receive 1.2 g/day Asacol. Subjects who weigh 33-<54 kg will receive 2.0 g/day Asacol. Subjects who weigh 54-<90 kg will receive 2.4 g/day Asacol.
951261|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
929982|NCT01004185|E1|Reported Event|High Dose|Subjects who weigh 17-<33 kg will receive 2.0 g/day Asacol. Subjects who weigh 33-<54 kg will receive 3.6 g/day Asacol. Subjects who weigh 54-<90 kg will receive 4.8 g/day Asacol.
929983|NCT01004172|B1|Baseline|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
929984|NCT01004172|P1|Participant Flow|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
929985|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1"
929986|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
929987|NCT01004172|O1|Outcome|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
929988|NCT01004172|E1|Reported Event|Carboplatin, Bevacizumab, Trastuzumab (if HER2+)|"Participants received treatment until disease progression in either CNS or non-CNS site. Cycle duration was 28 days.~carboplatin: AUC=5 dose given intravenously on day 8 of cycle one and Day 1 of each subsequent cycle bevacizumab: 15 mg/kg dose given intravenously on day 1 of each cycle trastuzumab*: 6 mg/kg dose given intravenously on day 8 of each cycle for patients with HER2-positive breast cancer only~*8mg/kg loading dose in cycle 1 for some participants"
929989|NCT01004159|B1|Baseline|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
929990|NCT01004159|P1|Participant Flow|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
929991|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
929992|NCT01004159|O1|Outcome|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
929993|NCT01004159|E1|Reported Event|Cetuximab With Irinotecan|cetuximab with irinotecan: Cetuximab administered 500mg/m2 over 120 minutes Irinotecan administered Q 3 weeks, Q 2 weeks or Q week x 4 every 6 weeks depending on patients previous treatment
929994|NCT01004146|B3|Baseline|Total|Total of all reporting groups
929995|NCT01004146|B2|Baseline|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
930096|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930097|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
929996|NCT01004146|B1|Baseline|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
929997|NCT01004146|P2|Participant Flow|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
929998|NCT01004146|P1|Participant Flow|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
929999|NCT01004146|O2|Outcome|Experimental Group|Patients assigned to the experimental group were instructed to use the spirometer by inhaling as slowly and deeply as possible in a set of 10 times and to repeat the process at least 5 times every day until the day of surgery.
930000|NCT01004146|O1|Outcome|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer and were instructed to use it for 3 breaths once per day to become able to use the device properly and consistently.
930001|NCT01004146|E2|Reported Event|Experimental Group|Patients assigned to the experimental group were instructed to use the incentive spirometer by inhaling as slowly and deeply as possible in a set of 10 times and were asked to repeat the process at least 5 times every day until the day of surgery. All patients in this group used the device at least 3 days prior to their surgical procedure.
930067|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930002|NCT01004146|E1|Reported Event|Control Group|Patients assigned to the control group were educated on the proper technique of using the incentive spirometer to familiarize themselves with the device. Subjects were instructed to use it for 3 breaths once per day so that they would able to use the device properly and consistently. All patients in this group used the device at least 3 days prior to their surgical procedure.
930003|NCT01004003|B10|Baseline|Total|Total of all reporting groups
930004|NCT01004003|B9|Baseline|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930005|NCT01004003|B8|Baseline|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930006|NCT01004003|B7|Baseline|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930007|NCT01004003|B6|Baseline|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930008|NCT01004003|B5|Baseline|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930009|NCT01004003|B4|Baseline|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930010|NCT01004003|B3|Baseline|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930011|NCT01004003|B2|Baseline|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930012|NCT01004003|B1|Baseline|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
930013|NCT01004003|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930014|NCT01004003|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930098|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930099|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930100|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930015|NCT01004003|P7|Participant Flow|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930016|NCT01004003|P6|Participant Flow|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930017|NCT01004003|P5|Participant Flow|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930018|NCT01004003|P4|Participant Flow|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930019|NCT01004003|P3|Participant Flow|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930020|NCT01004003|P2|Participant Flow|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930021|NCT01004003|P1|Participant Flow|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
930117|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930022|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930023|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930024|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930025|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930026|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930027|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930028|NCT01004003|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg)twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
930029|NCT01004003|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
930030|NCT01004003|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
930031|NCT01004003|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN."
930032|NCT01004003|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
930033|NCT01004003|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)."
930034|NCT01004003|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD).~Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN)."
930035|NCT01004003|O2|Outcome|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930036|NCT01004003|O1|Outcome|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930037|NCT01004003|O2|Outcome|Group 2|Patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930038|NCT01004003|O1|Outcome|Group 1|Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN)
930039|NCT01004003|E9|Reported Event|Phase II, 400 mg Sorafenib Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930040|NCT01004003|E8|Reported Event|Phase II, 200 mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macrovascular invasion (MVI) and/or extra-hepatic spread (EHS). Patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930118|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930041|NCT01004003|E7|Reported Event|Phase I Group 2, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930042|NCT01004003|E6|Reported Event|Phase I Group 2, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930043|NCT01004003|E5|Reported Event|Phase I Group 2, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930044|NCT01004003|E4|Reported Event|Phase I Group 2, 50mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 2 patients had a baseline Child-Pugh score of 7, or AST or ALT >2 to ≤5 times ULN.
930045|NCT01004003|E3|Reported Event|Phase I Group 1, 200mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules (two capsules of 100mg) twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930046|NCT01004003|E2|Reported Event|Phase I Group 1, 150mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the MTD. Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST and ALT ≤2 times the upper limit of normal (ULN).
930047|NCT01004003|E1|Reported Event|Phase 1 Group 1, 100mg Nintedanib Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid). Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD). Group 1 patients had a baseline Child-Pugh score of 5 or 6, and AST (aspartate aminotransferase ) and ALT (alanine transaminase) ≤2 times the upper limit of normal (ULN).
930048|NCT01003990|B4|Baseline|Total|Total of all reporting groups
930049|NCT01003990|B3|Baseline|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
930050|NCT01003990|B2|Baseline|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
930051|NCT01003990|B1|Baseline|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
930052|NCT01003990|P3|Participant Flow|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
930053|NCT01003990|P2|Participant Flow|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
930054|NCT01003990|P1|Participant Flow|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
930055|NCT01003990|O3|Outcome|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID Ritonavir: 100 mg BID Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
930056|NCT01003990|O2|Outcome|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
930058|NCT01003990|E3|Reported Event|Lopinavir/Ritonavir (LPV/RTV)|"Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).~Lopinavir: 400 mg BID; Ritonavir: 100 mg BID; Tenofovir/Emtricitabine: Tablets, Oral, 300/200 mg, once daily (QD) with food, indefinitely (one tablet with 300 mg - 200 mg QD)"
930059|NCT01003990|E2|Reported Event|Atazanavir/Ritonavir (ATV/RTV)|"Ritonavir-boosted Atazanavir (ATV/RTV 300/100 mg). Tablets administered orally once daily (QD) with food, indefinitely.~Ritonavir: 100 mg QD; Atazanavir: 300 mg QD (3 x 100 mg capsules, or 2 x 150 mg capsules)"
930060|NCT01003990|E1|Reported Event|Atazanavir (ATV)|Atazanavir: Tablets, Oral, 400 mg (2 x 200 mg capsules), once daily with food, indefinitely
930061|NCT01003938|B1|Baseline|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930062|NCT01003938|P1|Participant Flow|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930063|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930064|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930065|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930066|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930068|NCT01003938|O1|Outcome|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930069|NCT01003938|E1|Reported Event|Topotecan and Erlotinib|On Day 1 of each treatment cycle, topotecan 0.4 mg/m^2/day was administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle. Plus erlotinib 150 mg daily for 9 days every 21 days cycle.
930070|NCT01003899|B1|Baseline|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930071|NCT01003899|P1|Participant Flow|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930072|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930073|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930074|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930075|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930076|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930077|NCT01003899|O1|Outcome|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930078|NCT01003899|E1|Reported Event|Afatinib 40 mg|Afatinib 40 mg film coated tablets where administered on continuous daily dosing until progression, unacceptable adverse events or other reasons necessitating withdrawal
930079|NCT01003886|B1|Baseline|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930080|NCT01003886|P1|Participant Flow|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930081|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930082|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930083|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930084|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930085|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930086|NCT01003886|O1|Outcome|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930087|NCT01003886|E1|Reported Event|Doxazosin GITS|Doxazosin mesylate gastrointestinal therapeutic system (GITS) tablet taken orally at a dose of 4 milligram (mg) once daily (QD) or 8 mg QD for 12 weeks.
930088|NCT01002742|B3|Baseline|Total|Total of all reporting groups
930089|NCT01002742|B2|Baseline|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930090|NCT01002742|B1|Baseline|Placebo|Corticosteroids with placebo
930091|NCT01002742|P2|Participant Flow|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930101|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930102|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930103|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930104|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930105|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930106|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930107|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930108|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930109|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930110|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930111|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930112|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930113|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930114|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930115|NCT01002742|O2|Outcome|Mycophenolate Mofetil|Corticosteroids with Mycophenolate Mofetil
930116|NCT01002742|O1|Outcome|Placebo|Corticosteroids with placebo
930126|NCT01003301|B2|Baseline|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930127|NCT01003301|B1|Baseline|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930128|NCT01003301|P2|Participant Flow|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930129|NCT01003301|P1|Participant Flow|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930130|NCT01003301|O2|Outcome|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930131|NCT01003301|O1|Outcome|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930132|NCT01003301|E2|Reported Event|Placebo|"This arm will receive treatment with a placebo injections based on the FDA-approved dosing schedule approved for omalizumab for the treatment of allergic asthma.In general injection number and frequency are determined by a subject's weight and IgE level.~Placebo: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930133|NCT01003301|E1|Reported Event|Omalizumab|"Active treatment: Experimental This arm will receive treatment with omalizumab at the dose FDA-approved for the treatment of allergic asthma.~Omalizumab: Injections subcutaneously (up to 3) every 2 or 4 wks based on the subjects weight and baseline total serum IgE level as approved for therapy in allergic asthma. Duration of therapy is approximately 14 wks."
930134|NCT01003288|B3|Baseline|Total|Total of all reporting groups
930135|NCT01003288|B2|Baseline|Hypogammaglobulinaemic Patients|Received two doses of pandemic vaccine
930136|NCT01003288|B1|Baseline|Health Care Workers|Received one or two doses of pandemic vaccine during 2009 pandemic and susbequent seasonal vaccination was optional
930137|NCT01003288|P1|Participant Flow|Pandemic Influenza Vaccine (H1N1)v|"Pandemrix: Vaccination Pandemrix suspension and emulsion for emulsion for injection. 1 dose (0.5 ml) contains Split influenza virus, inactivated, containing antigen 3.75 micrograms of A/California/7/2009 (H1N1)v-like strain (X-179A)~* Pandemic influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted)"
930138|NCT01003288|O1|Outcome|HCW Pandemic Vaccine|
930139|NCT01003288|O1|Outcome|Pandemic Vaccine|Pandemic Vaccine in HCW
930140|NCT01003288|E1|Reported Event|Pandemic Vaccine|HCW vaccinated with pandemic vaccine
930141|NCT01003275|B3|Baseline|Total|Total of all reporting groups
930142|NCT01003275|B2|Baseline|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
930143|NCT01003275|B1|Baseline|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
930144|NCT01003275|P2|Participant Flow|Placebo Followed by Paricalcitol|Participants will receive placebo for 8 weeks, then an 8-week wash-out, then paricalcitol for 8 weeks.
930145|NCT01003275|P1|Participant Flow|Paricalcitol Followed by Placebo|Participants will receive paricalcitol for 8 weeks, then an 8-week wash-out, then placebo for 8 weeks.
930146|NCT01003275|O2|Outcome|During Placebo Treatment|
930147|NCT01003275|O1|Outcome|During Paricalcitol Treatment|
930148|NCT01003275|E2|Reported Event|During/After Placebo|
930149|NCT01003275|E1|Reported Event|During/After Paricalcitol|
930150|NCT01003210|B3|Baseline|Total|Total of all reporting groups
930151|NCT01003210|B2|Baseline|Standard Therapy|standard therapy for otitis media, no ear drops
930152|NCT01003210|B1|Baseline|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
930153|NCT01003210|P2|Participant Flow|Standard Therapy|standard therapy for otitis media, no ear drops
930154|NCT01003210|P1|Participant Flow|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
930155|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
930156|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
930157|NCT01003210|O2|Outcome|Standard Therapy|standard therapy for otitis media, no ear drops
930158|NCT01003210|O1|Outcome|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
930159|NCT01003210|E2|Reported Event|Standard Therapy|standard therapy for otitis media, no ear drops
930160|NCT01003210|E1|Reported Event|Homeopathic Ear Drops|"Commercially available homeopathic ear drops~Hyland's earache drops: 3-4 drops in affected ear 3 times a day as needed for up to 5 days"
930162|NCT01003184|B2|Baseline|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930163|NCT01003184|B1|Baseline|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930164|NCT01003184|P2|Participant Flow|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930165|NCT01003184|P1|Participant Flow|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930166|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930167|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930168|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930169|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930170|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930171|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930172|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930173|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930174|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930175|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930176|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930177|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930178|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930179|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930180|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930181|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930182|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930183|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930184|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930185|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930186|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930187|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930188|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930189|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930190|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930191|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930192|NCT01003184|O2|Outcome|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930193|NCT01003184|O1|Outcome|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930194|NCT01003184|E2|Reported Event|Insulin Detemir|Insulin detemir : subcutaneous injection, with dosage titrated according to the detemir label and published titration schedule, once or twice a day
930269|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930195|NCT01003184|E1|Reported Event|Exenatide Once Weekly|Exenatide once weekly : subcutaneous injection, 2mg, once a week
930196|NCT01003106|B5|Baseline|Total|Total of all reporting groups
930197|NCT01003106|B4|Baseline|CRVO- Ranibizumab 2.0mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~CRVO- Ranibizumab 2.0 mg alone: Central retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
930198|NCT01003106|B3|Baseline|CRVO- Ranibizumab 0.5mg Alone|"Central retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation~CRVO -Ranibizumab 0.5mg alone: Central retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
930199|NCT01003106|B2|Baseline|BRVO- Ranibizumab 2.0mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO- Ranibizumab 2.0 mg alone: Branch retinal vein occlusion- Intravitreal injection of 2.0mg ranibizumab alone"
930200|NCT01003106|B1|Baseline|BRVO- Ranibizumab 0.5mg Alone|"Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone as per protocol without laser photocoagulation.~BRVO -Ranibizumab 0.5mg alone: Branch retinal vein occlusion- Intravitreal injection of 0.5mg ranibizumab alone"
930481|NCT01001702|P1|Participant Flow|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930201|NCT01003106|P8|Participant Flow|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients randomized to this group at month 6 will receive 0.5mg/2.0mg prn ranibizumab along with laser photocoagulation.
930202|NCT01003106|P7|Participant Flow|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
930203|NCT01003106|P6|Participant Flow|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive ranibizumab 2.0mg alone for 6 months .
930204|NCT01003106|P5|Participant Flow|CRVO- Ranibizumab 0.5mg Alone|Central retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg at of ranibizumab alone for 6 months.
930205|NCT01003106|P4|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata (prn) ranibizumab along with laser photocoagulation.
930206|NCT01003106|P3|Participant Flow|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients randomized to this group at month 6 will receive pro re nata 0.5mg/2.0mg of ranibizumab without laser photocoagulation.
930207|NCT01003106|P2|Participant Flow|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 2.0mg of Ranibizumab alone for 6 months.
930208|NCT01003106|P1|Participant Flow|BRVO- Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group at baseline will receive 0.5mg of ranibizumab alone for 6 months.
930209|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
930210|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
930211|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
930212|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
930213|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
930214|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
930215|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
930216|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
930217|NCT01003106|O4|Outcome|CRVO- Pro re Nata (PRN) Ranibizumab+Laser Photocoagulation|Central retinal vein occlusion patients in this group will receive 0.5mg/2.0mg prn ranibizumab and laser photocoagulation.
930218|NCT01003106|O3|Outcome|CRVO- Pro re Nata (Prn) Ranibizumab Alone|Central retinal vein occlusion patients in this group will receive pro re nata (prn) 0.5mg/2.0mg ranibizumab alone without laser photocoagulation.
930219|NCT01003106|O2|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab+Laser Photocoagulation|Branch retinal vein occlusion patients in this group will receive pro re nata (prn) ranibizumab and laser.
930220|NCT01003106|O1|Outcome|BRVO- Pro re Nata (Prn) Ranibizumab Alone|Branch retinal vein occlusion patients in this group will receive pro re nata 0.5mg/2.0mg of ranibizumab along without laser photocoagulation.
930221|NCT01003106|O4|Outcome|CRVO- Ranibizumab 2.0mg Alone|Central retinal vein occlusion patients randomized to receive 2.0mg of ranibizumab alone.
930222|NCT01003106|O3|Outcome|CRVO- Ranibizumab 0.5mg Alone|Patients randomized to receive 0.5mg of ranibizumab alone
930223|NCT01003106|O2|Outcome|BRVO- Ranibizumab 2.0mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 2.0mg of ranibizumab alone.
930224|NCT01003106|O1|Outcome|BRVO-Ranibizumab 0.5mg Alone|Branch retinal vein occlusion patients randomized to this group will receive 0.5mg of ranibizumab alone.
930225|NCT01003106|O2|Outcome|CRVO|Patients with Central Retinal Vein Occlusion
930226|NCT01003106|O1|Outcome|BRVO|Patients with Branch Retinal Vein Occlusion
930227|NCT01003106|E2|Reported Event|CRVO|Patients with Central Retinal Vein Occlusion
930228|NCT01003106|E1|Reported Event|BRVO|Patients with Branch Retinal Vein Occlusion
930229|NCT01003080|B3|Baseline|Total|Total of all reporting groups
930230|NCT01003080|B2|Baseline|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
938580|NCT00984308|E1|Reported Event|Intervention|
930231|NCT01003080|B1|Baseline|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
930232|NCT01003080|P2|Participant Flow|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
930233|NCT01003080|P1|Participant Flow|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
930234|NCT01003080|O2|Outcome|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
930235|NCT01003080|O1|Outcome|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
930236|NCT01003080|E2|Reported Event|TKA Without the Aquamantys for Hemostasis|This group will receive total knee arthroplasty using the standard treatment for hemostasis.
930237|NCT01003080|E1|Reported Event|TKA With the Aquamantys for Hemostasis|This arm will receive the total knee arthroplasty with the Aquamantys device used for hemostasis.
930238|NCT01003067|B3|Baseline|Total|Total of all reporting groups
930239|NCT01003067|B2|Baseline|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
930281|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930240|NCT01003067|B1|Baseline|No Mesh|The closure technique consisted of a single-layer continuous suture technique with picking up all layers of the abdominal wall apart from subcutaneous fat and skin (peritoneum, posterior rectus sheath, rectus muscle and anterior rectus sheath).
930241|NCT01003067|P2|Participant Flow|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
930242|NCT01003067|P1|Participant Flow|No Mesh|conventional abdominal closure with a suture
930243|NCT01003067|O2|Outcome|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
930244|NCT01003067|O1|Outcome|No Mesh|conventional abdominal closure with a suture
930245|NCT01003067|E2|Reported Event|Mesh Implementation|Mesh implementation: Prophylactic intraperitoneal mesh implantation in laparoscopic surgery to prevent incisional hernia.
930246|NCT01003067|E1|Reported Event|No Mesh|conventional abdominal closure with a suture
930247|NCT01002989|B1|Baseline|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
930248|NCT01002989|P1|Participant Flow|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
930249|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
930250|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
930251|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
930252|NCT01002989|O1|Outcome|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
930253|NCT01002989|E1|Reported Event|Hypertensives|Subjects assessed for hypertension underwent manual Doppler ABI measurement using a continuous wave Doppler device (Hadeco Bidop ES-100V3, Kawasaki, Japan) with a 8 MHz probe and automated ABI measurement using a validated oscillometric blood pressure monitor designed for professional use in the office (WatchBP Office device; Microlife, Widnau, Switzerland).
930254|NCT01002573|B3|Baseline|Total|Total of all reporting groups
930255|NCT01002573|B2|Baseline|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930256|NCT01002573|B1|Baseline|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930257|NCT01002573|P2|Participant Flow|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930258|NCT01002573|P1|Participant Flow|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930259|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930260|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930261|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930262|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930263|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930264|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930265|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930266|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930267|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930268|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930270|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930271|NCT01002573|O2|Outcome|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930272|NCT01002573|O1|Outcome|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930273|NCT01002573|E2|Reported Event|Acetaminophen|"Acetaminophen, 10mg/kg~acetaminophen: Acetaminophen, 10mg/kg"
930274|NCT01002573|E1|Reported Event|Ibuprofen|"Ibuprofen, 10 mg/kg~ibuprofen: Ibuprofen, 10 mg/kg"
930275|NCT01002482|B3|Baseline|Total|Total of all reporting groups
930276|NCT01002482|B2|Baseline|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930277|NCT01002482|B1|Baseline|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930278|NCT01002482|P2|Participant Flow|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930279|NCT01002482|P1|Participant Flow|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930280|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930283|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930284|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930285|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930286|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930287|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930288|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930289|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930290|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930291|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930292|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930293|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930294|NCT01002482|O2|Outcome|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930295|NCT01002482|O1|Outcome|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930296|NCT01002482|E2|Reported Event|Standard-Care Glucose Gontrol|Use of Standard-Care Methods for Glucose Control targeting Blood Glucose Levels inferior to 10 mmol/l.
930297|NCT01002482|E1|Reported Event|CGAO-based Glucose Control|Use of a Computerized Protocol fot Tight Glycemic Control named CGAO software in order to maintain Blood Glucose Levels between 4.4 and 6.1 mmol/l.
930298|NCT01002456|B3|Baseline|Total|Total of all reporting groups
930299|NCT01002456|B2|Baseline|Level 2|site- and patient-specific information provided
930300|NCT01002456|B1|Baseline|Level 1|site-specific information provided
930301|NCT01002456|P2|Participant Flow|Arm 2|"provide site- and patient-specific information~Level 2 (Provide site- and patient-specific information): provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions"
930302|NCT01002456|P1|Participant Flow|Arm 1|"provide site-specific information~Level 1 (Provide site-specific information): provide site-specific information on non-adherence to guideline"
930303|NCT01002456|O2|Outcome|Level 2:Provide Site- and Patient-specific Information|Level 2:provide site- and patient-specific information on nonadherence
930304|NCT01002456|O1|Outcome|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on nonadherence
930305|NCT01002456|O2|Outcome|Level 2|provide site- and patient-specific information
930306|NCT01002456|O1|Outcome|Level 1|provide site-specific information
930307|NCT01002456|E2|Reported Event|Level 2: Provide Site- and Patient-specific Information|Level 2: provide site-specific information on non-adherence to guideline as well as list of patients with non-adherent prescriptions
930308|NCT01002456|E1|Reported Event|Level 1: Provide Site-specific Information|Level 1: provide site-specific information on non-adherence
930309|NCT01002339|B4|Baseline|Total|Total of all reporting groups
930310|NCT01002339|B3|Baseline|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930311|NCT01002339|B2|Baseline|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930385|NCT01002105|P2|Participant Flow|Placebo|Placebo, identical to baclofen was administered to the placebo group for 12 weeks
938581|NCT00984295|B4|Baseline|Total|Total of all reporting groups
930312|NCT01002339|B1|Baseline|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930313|NCT01002339|P3|Participant Flow|Cyclosporin A (CsA) With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930314|NCT01002339|P2|Participant Flow|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930392|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
930315|NCT01002339|P1|Participant Flow|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930316|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930317|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930318|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930319|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930320|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930321|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930322|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930323|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930324|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930325|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930384|NCT01002105|B1|Baseline|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
930326|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930327|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930328|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930329|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930393|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
930330|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930331|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930332|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930333|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930334|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930335|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930336|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930337|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930338|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930339|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930340|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930341|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930342|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930343|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930344|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930468|NCT01001806|E3|Reported Event|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
951262|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
930345|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930346|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930347|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930348|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930349|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930350|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930351|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930352|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930353|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930354|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930355|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930356|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930357|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930358|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930359|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930469|NCT01001806|E2|Reported Event|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
930360|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930361|NCT01002339|O3|Outcome|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930362|NCT01002339|O2|Outcome|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930363|NCT01002339|O1|Outcome|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930364|NCT01002339|E3|Reported Event|CsA With Steroid Minimization|"CsA plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~CsA with steroid minimization: CsA 5 mg/Kg/day to achieve target trough of 150-200 ng/ml the first month, and similar pattern with MMF and steroids as group 2. Basiliximab induction (4 mg, days 0 and 4)."
930365|NCT01002339|E2|Reported Event|Tacrolimus With Steroids Minimization|"Tacrolimus plus Mycophenolate mofetil (MMF) and low-dose corticosteroids for 6 months with subsequent removal~Tacrolimus with steroids minimization: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of MP intraoperatively and 60 mg day 1; followed by oral doses of prednisone and gradual tapering to complete discontinuation over 6 months. Basiliximab induction (4 mg, days 0 and 4)."
930366|NCT01002339|E1|Reported Event|Tacrolimus With Rapid Steroid Withdrawal|"Tacrolimus plus Mycophenolate mofetil (MMF), and corticosteroids with rapid withdrawal after one week.~Tacrolimus with rapid steroid withdrawal: Tacrolimus 0.15 mg/Kg/day to achieve target trough levels of 8-12 ng/ml for the first month, and MMF 2 gr/day; steroids: 0.5 gr of Methylprednisolone (MP) intraoperatively and 125 mg on the first day, followed by oral doses of prednisone rapidly tapered from 30 mg/day to complete discontinuation by postoperative day 7. Basiliximab induction (4 mg, days 0 and 4)."
930367|NCT01002287|B3|Baseline|Total|Total of all reporting groups
930368|NCT01002287|B2|Baseline|Control|Good Surgical Technique Alone
930369|NCT01002287|B1|Baseline|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
930370|NCT01002287|P2|Participant Flow|Control|Good Surgical Technique Alone
930371|NCT01002287|P1|Participant Flow|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
930372|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
930373|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
930374|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
930375|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
930376|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
930377|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
930378|NCT01002287|O2|Outcome|Control|Good Surgical Technique Alone
930379|NCT01002287|O1|Outcome|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier
930380|NCT01002287|E2|Reported Event|Control|Good Surgical Technique Alone
930381|NCT01002287|E1|Reported Event|SprayShield Adhesion Barrier|SprayShield Adhesion Barrier + Good Surgical Technique
930382|NCT01002105|B3|Baseline|Total|Total of all reporting groups
930383|NCT01002105|B2|Baseline|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
940131|NCT00980174|E2|Reported Event|Denosumab 60 mg Q6M|
930386|NCT01002105|P1|Participant Flow|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
930387|NCT01002105|O2|Outcome|Placebo|IThe placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations
930388|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
930389|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
930390|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
930391|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
930618|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930394|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks and psychosocial intervention"
930395|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
930396|NCT01002105|O1|Outcome|Baclofen|The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. Baclofen: Baclofen 50mg per day for 12 weeks
930397|NCT01002105|O2|Outcome|Placebo|Patients were randomly assigned either to baclofen (N=32) or placebo (N=32) in a double-blind study design
930398|NCT01002105|O1|Outcome|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
930399|NCT01002105|E2|Reported Event|Placebo|The placebo group received a placebo, identical to the baclofen medication for 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.
930400|NCT01002105|E1|Reported Event|Baclofen|"The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations.~Baclofen: Baclofen 50mg per day for 12 weeks"
930401|NCT01001975|B3|Baseline|Total|Total of all reporting groups
930402|NCT01001975|B2|Baseline|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
930403|NCT01001975|B1|Baseline|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
930404|NCT01001975|P2|Participant Flow|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
930405|NCT01001975|P1|Participant Flow|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
930406|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
930407|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
930408|NCT01001975|O2|Outcome|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
930409|NCT01001975|O1|Outcome|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
930410|NCT01001975|E2|Reported Event|UVA Protection Testing|Determination of Ultraviolet A Protection Factor (PFA). Following FDA guidelines, test sites exposed to UVA are scored for pigmentation responses 2 to 4 hours post-exposure.
930411|NCT01001975|E1|Reported Event|Sun Protection Factor (SPF) Testing|Following Food and Drug Administration (FDA) guidelines for SPF testing, exposure control and product-protected site erythema responses are scored after 16 to 24 hours post-exposure to full spectrum light (Ultraviolet Radiation A [UVA] and ultraviolet radiation B [UVB]).
930412|NCT01001832|B3|Baseline|Total|Total of all reporting groups
930413|NCT01001832|B2|Baseline|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930513|NCT01001559|P1|Participant Flow|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
930414|NCT01001832|B1|Baseline|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930415|NCT01001832|P2|Participant Flow|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930416|NCT01001832|P1|Participant Flow|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930470|NCT01001806|E1|Reported Event|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
930471|NCT01001767|B3|Baseline|Total|Total of all reporting groups
930472|NCT01001767|B2|Baseline|Placebo|Placebo capsule by mouth twice a day x 24 weeks
930417|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930418|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930419|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930420|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930421|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930422|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930423|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930424|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930425|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930426|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930455|NCT01001832|E3|Reported Event|Short Term Subcutaneous (SC) Abatacept, 125 mg|Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.
930427|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930428|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930429|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930430|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930473|NCT01001767|B1|Baseline|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
930474|NCT01001767|P2|Participant Flow|Placebo|Placebo capsule by mouth twice a day x 24 weeks
930431|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930432|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930433|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930434|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930435|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930436|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930437|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930438|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930439|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930440|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930441|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930442|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930443|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930444|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930475|NCT01001767|P1|Participant Flow|Lovaza|Lovaza 1 gram by mouth twice a day x 24 weeks
930476|NCT01001767|O2|Outcome|Placebo|Placebo capsule by mouth twice a day x 24 weeks
930445|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930446|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930447|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930448|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930449|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930450|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930451|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930452|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo).~Follow-up period was up to 168 days after the last dose of drug."
930453|NCT01001832|O2|Outcome|Intravenous (IV) Abatacept, 125 mg|"Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
930454|NCT01001832|O1|Outcome|Subcutaneous (SC) Abatacept, 125 mg|"Short-term period: Participants received SC abatacept, 125 mg, injections weekly, after an intravenous (IV) abatacept loading dose on Day 1, based on body weight. Participants also received SC injections of placebo, with a loading dose of IV abatacept (and not IV placebo) administered on Day 1.~Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo)."
930512|NCT01001559|P2|Participant Flow|Antidepressant Alone|SSRI or SNRI alone
930514|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
930456|NCT01001832|E2|Reported Event|Short Term Intravenous (IV) Abatacept, 125 mg|Short-term period: Participants received IV abatacept, 125 mg, infusions on Days 1, 15, and 29, and every 28 days thereafter until Day 141. Participants also received subcutaneous (SC) injections of placebo.
930457|NCT01001832|E1|Reported Event|Abatacept Long-term (LT) SC 125 mg|Long-term period: All participants received weekly SC abatacept, 125 mg, for 1 year (52 weeks) without any IV infusions (active or placebo). Follow-up was up to 168 days after the last dose of drug.
930458|NCT01001806|B4|Baseline|Total|Total of all reporting groups
930459|NCT01001806|B3|Baseline|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
930460|NCT01001806|B2|Baseline|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
930461|NCT01001806|B1|Baseline|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
930462|NCT01001806|P3|Participant Flow|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
930463|NCT01001806|P2|Participant Flow|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
930464|NCT01001806|P1|Participant Flow|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
930465|NCT01001806|O3|Outcome|Nevanac|One day before surgery 1 drop BID, then 3 doses pre op day of surgery
930466|NCT01001806|O2|Outcome|Xibrom|Xibrom to be given 1 drop BID the day before surgery and 3 doses the day of surgery prior to surgery
930467|NCT01001806|O1|Outcome|Acuvail|Acuvail to be given preoperatively. One drop BID, 1 day pre op and day of surgery 3 doses prior to surgery
951263|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
930482|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930483|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930484|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930485|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930486|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930487|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930488|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930489|NCT01001702|O1|Outcome|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930490|NCT01001702|E1|Reported Event|Oral Aripiprazole|Flexible dose of oral aripiprazole between 5 mg and 30 mg once daily for 72 months.
930491|NCT01001572|B3|Baseline|Total|Total of all reporting groups
930492|NCT01001572|B2|Baseline|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930493|NCT01001572|B1|Baseline|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930494|NCT01001572|P3|Participant Flow|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930495|NCT01001572|P2|Participant Flow|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930496|NCT01001572|P1|Participant Flow|Single-Blind Run -In Valsartan 160 mg|Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.
930497|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930498|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930499|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930500|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930501|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930502|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930503|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930504|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930505|NCT01001572|O2|Outcome|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930506|NCT01001572|O1|Outcome|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930507|NCT01001572|E2|Reported Event|Valsartan 160 mg|One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
930508|NCT01001572|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks.
930509|NCT01001559|B3|Baseline|Total|Total of all reporting groups
930510|NCT01001559|B2|Baseline|Antidepressant Alone|SSRI or SNRI alone
930511|NCT01001559|B1|Baseline|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
930515|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
930516|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
930517|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
930518|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
930519|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
930520|NCT01001559|O2|Outcome|Antidepressant Alone|SSRI or SNRI alone
930521|NCT01001559|O1|Outcome|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
930522|NCT01001559|E2|Reported Event|Antidepressant Alone|SSRI or SNRI alone
930523|NCT01001559|E1|Reported Event|Deplin + Antidepressant|Deplin in combination with a selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)
930524|NCT01001546|B3|Baseline|Total|Total of all reporting groups
930525|NCT01001546|B2|Baseline|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
930526|NCT01001546|B1|Baseline|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
930527|NCT01001546|P2|Participant Flow|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
930528|NCT01001546|P1|Participant Flow|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
930529|NCT01001546|O2|Outcome|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
930530|NCT01001546|O1|Outcome|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
930531|NCT01001546|E2|Reported Event|Control|"Clinic-based smoking cessation~Standard Clinic-Based: Veterans randomized to the control condition will have a consult placed to the DVAMC specialty Smoking Cessation Clinic placed on their behalf."
930532|NCT01001546|E1|Reported Event|Intervention|"Internet-based smoking cessation~Internet-based: Veterans randomized to the QuitNet will immediately be given access to the Premium, lifetime membership services."
930533|NCT01001520|B1|Baseline|Entire Study Population|Includes all subjects who were randomized to both study treatment groups (i.e., receive both placebo first and tolcapone first) and initiated study medication.
930534|NCT01001520|P2|Participant Flow|Tolcapone First, Then Placebo|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took tolcapone during the first medication period, followed by a placebo during the second medication period.~During the active tolcapone medication period, subjects followed a tapered dosing schedule (see protocol section for complete description)."
930535|NCT01001520|P1|Participant Flow|Placebo First, Then Tolcapone|"Subjects were asked to take study medication each day during two 11-day study medication periods. Between the two study medication periods was a washout period (no medication or visits) that lasted at least 10 days. During this washout period, subjects did not take any study medication and were asked to return to their normal smoking levels.~Study medication assignment for each subject was randomized and counterbalanced, meaning approximately 50% of subjects took placebo during the first medication period, followed by tolcapone during the second medication period.~During the placebo medication period, subjects followed a medication regimen and took capsules that were identical to those in the active tolcapone medication period (see protocol section for complete description)."
930536|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930537|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930538|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930539|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930540|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930541|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930542|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930543|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930544|NCT01001520|O2|Outcome|Tolcapone|"See Protocol or Participant Flow sections for full description of this study arm."
930545|NCT01001520|O1|Outcome|Placebo|"See Protocol or Participant Flow sections for full description of this study arm."
930546|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930547|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930548|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930549|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930550|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930551|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930552|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930553|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930554|NCT01001520|O2|Outcome|Tolcapone|"11-day medication period following a tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during this period, the capsules contained the active medication, tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)"
930555|NCT01001520|O1|Outcome|Placebo|"An 11-day placebo-controlled medication period.~Both medication periods involved taking identical capsules in the same tapered-dose regimen (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily). The only difference was that, during the placebo period, the capsules did not contain tolcapone.~All medication was encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)."
930556|NCT01001520|E2|Reported Event|Tolcapone|"11-day phase, tapered dosing scheduled (Day 1: 100mg three times daily, Days 2-8: 200mg three times daily, Day 9: 200mg twice daily, Day 10: 200mg once daily, Day 11: 100mg once daily); oral dosing; medication is encapsulated by the University of Pennsylvania's Investigational Drug Service (IDS)~Tolcapone: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
930557|NCT01001520|E1|Reported Event|Placebo|"11-day placebo-controlled medication period. Placebo capsules are identical to those in the active tolcapone treatment. When taking placebo, subjects follow an identical dosing schedule as the active treatment period.~Placebo: Participants will be asked to take study medication each day for both 11-day study medication periods.~The study medication assignments for each participant in this project is randomized and counterbalanced. This means that approximately 50% of participants will take tolcapone during the first medication period, followed by the placebo in the second medication period. Alternatively, approximately 50% of participants will take the placebo during the first medication period, followed by tolcapone during the second medication period."
930558|NCT01001494|B4|Baseline|Total|Total of all reporting groups
930559|NCT01001494|B3|Baseline|Placebo|Placebo via inhalation
930560|NCT01001494|B2|Baseline|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930561|NCT01001494|B1|Baseline|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930562|NCT01001494|P3|Participant Flow|Placebo|Placebo via inhalation
930563|NCT01001494|P2|Participant Flow|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930564|NCT01001494|P1|Participant Flow|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930565|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
930566|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930567|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930568|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
930569|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930570|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930571|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
930572|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930573|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930574|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
930575|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930576|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930577|NCT01001494|O3|Outcome|Placebo|Placebo via inhalation
930578|NCT01001494|O2|Outcome|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930579|NCT01001494|O1|Outcome|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930580|NCT01001494|E3|Reported Event|Placebo|Placebo via inhalation
930581|NCT01001494|E2|Reported Event|Aclidinium Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
930582|NCT01001494|E1|Reported Event|Aclidinium Bromide 200 μg Bid|Aclidinium bromide 200 μg twice-daily via inhalation
930583|NCT01001403|B3|Baseline|Total|Total of all reporting groups
930584|NCT01001403|B2|Baseline|Control|
930585|NCT01001403|B1|Baseline|Nafamostat|
930586|NCT01001403|P2|Participant Flow|Control|
930587|NCT01001403|P1|Participant Flow|Nafamostat|
930588|NCT01001403|O2|Outcome|Control|
930589|NCT01001403|O1|Outcome|Nafamostat|
930590|NCT01001403|E2|Reported Event|Control|
930591|NCT01001403|E1|Reported Event|Nafamostat|
930592|NCT01001390|B1|Baseline|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
930593|NCT01001390|P2|Participant Flow|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
930594|NCT01001390|P1|Participant Flow|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
930595|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
930596|NCT01001390|O1|Outcome|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
930597|NCT01001390|E2|Reported Event|Group 2: Without Then With AFO|Group two participants were to complete a six minute walk test without ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test with AFO, with similar speed to the previous test. The process was to be repeated one month later.
930598|NCT01001390|E1|Reported Event|Group 1: With Then Without AFO|Group one participants were to complete a six minute walk test with ankle foot orthoses (AFO), and after a rest of fifteen minutes, they were to complete another six minute walk test without AFO, with similar speed to the previous test. The process was to be repeated one month later.
930599|NCT01001377|B3|Baseline|Total|Total of all reporting groups
930600|NCT01001377|B2|Baseline|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930601|NCT01001377|B1|Baseline|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930602|NCT01001377|P2|Participant Flow|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930603|NCT01001377|P1|Participant Flow|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930604|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930605|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930606|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930607|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930608|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930609|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930610|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930611|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930612|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930613|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930614|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930615|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930616|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930617|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930619|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930620|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930621|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930622|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930623|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930624|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930625|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930626|NCT01001377|O2|Outcome|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930627|NCT01001377|O1|Outcome|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930628|NCT01001377|E2|Reported Event|Panitumumab|Panitumumab 6 mg/kg IV every 14 days.
930629|NCT01001377|E1|Reported Event|Cetuximab|Cetuximab 400 mg/m^2 as an initial dose, followed by 250 mg/m^2 intravenously (IV) every 7 days.
930630|NCT01001325|B3|Baseline|Total|Total of all reporting groups
930631|NCT01001325|B2|Baseline|Placebo|0.5 mL normal saline
930632|NCT01001325|B1|Baseline|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
930633|NCT01001325|P2|Participant Flow|Placebo|0.5 mL normal saline
930634|NCT01001325|P1|Participant Flow|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
930635|NCT01001325|O2|Outcome|Placebo|0.5 mL normal saline
930636|NCT01001325|O1|Outcome|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
930637|NCT01001325|E2|Reported Event|Placebo|0.5 mL normal saline
930638|NCT01001325|E1|Reported Event|Seasonal Influenza Vaccination|Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
930639|NCT01001299|B1|Baseline|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930640|NCT01001299|P1|Participant Flow|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 milligrams [mg] tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 milligrams per kilogram [mg/kg] syrup) on Day 1, followed by 5-day washout. Vemurafenib (RO5185426) 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930641|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930642|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930663|NCT01001234|B6|Baseline|Total|Total of all reporting groups
930692|NCT01001221|P2|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930643|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930644|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930645|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930646|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930647|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930648|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930649|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930650|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930651|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930652|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930664|NCT01001234|B5|Baseline|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
940132|NCT00980174|E1|Reported Event|Placebo|
930653|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930654|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930655|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930669|NCT01001234|P5|Participant Flow|Rizatriptan/Placebo|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), allocated to receive single placebo oral tablet in Stage 2 to treat same qualifying migraine treated in Stage 1 (Stage 2 dose to be administered 15 minutes post Stage 1 dose).
930656|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930657|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930658|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930659|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930660|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930661|NCT01001299|O1|Outcome|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930662|NCT01001299|E1|Reported Event|Vemurafenib|Single oral doses of 5 probe drugs (caffeine 200 mg tablet, warfarin 10 mg tablet [with Vitamin K 10 mg {2*5 mg tablets}], omeprazole 40 mg capsule, dextromethorphan 30 mg syrup, and midazolam 0.075 mg/kg syrup) on Day 1, followed by 5-day washout. Vemurafenib 960 mg (4*240 mg film-coated tablets) orally twice daily on Day 6 to Day 19. Single oral doses of 5 probe drugs co-administered with vemurafenib 960 mg on Day 20, followed by vemurafenib 960 mg orally twice daily up to Day 28 and then vemurafenib 960 mg orally twice daily continuously in 28-day cycles until disease progression, toxicity, withdrawal of consent, loss to follow-up, or death (whichever occurred first).
930665|NCT01001234|B4|Baseline|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
930666|NCT01001234|B3|Baseline|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
930667|NCT01001234|B2|Baseline|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
930668|NCT01001234|B1|Baseline|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
930900|NCT01001195|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930670|NCT01001234|P4|Participant Flow|Placebo/Placebo|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single placebo oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
930671|NCT01001234|P3|Participant Flow|Placebo/Rizatriptan|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Non-Responder (moderate or severe pain 15 minutes after dose), Stage 2 randomization was to occur and participants in this reporting group received single rizatriptan 5 or 10 mg oral tablet. Stage 2 dose was administered approximately 15 minutes post Stage 1 dose, to treat same qualifying migraine treated in Stage 1. Stage 2 randomization was in a ratio of 1:1 rizatriptan:placebo.
930672|NCT01001234|P2|Participant Flow|Rizatriptan/NA|Stage 1 - Randomized to single rizatriptan 5 or 10 mg oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
930673|NCT01001234|P1|Participant Flow|Placebo/NA|Stage 1 - Randomized to single placebo oral tablet to be taken within 30 minutes of onset of qualifying migraine / Stage 2 - If Stage 1 dose was taken and participant was Responder (mild or no pain 15 minutes after dose), no further study medication was to be administered.
930674|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
930675|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
930676|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
930677|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
930678|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
930679|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
930680|NCT01001234|O2|Outcome|Placebo|Participants randomized to placebo in Stage 2
930681|NCT01001234|O1|Outcome|Rizatriptan|Participants randomized to rizatriptan in Stage 2
930682|NCT01001234|E2|Reported Event|Placebo|Participants who took only placebo during the study
930683|NCT01001234|E1|Reported Event|Rizatriptan|Participants who took any rizatriptan during the study (Stage 1 or 2)
930684|NCT01001221|B5|Baseline|Total|Total of all reporting groups
930685|NCT01001221|B4|Baseline|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930686|NCT01001221|B3|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930687|NCT01001221|B2|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930688|NCT01001221|B1|Baseline|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930689|NCT01001221|P5|Participant Flow|Part 2: Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the Maximum Tolerated Dose (MTD) as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930690|NCT01001221|P4|Participant Flow|Part 1: Gemcitabine + Cabazitaxel Dose Level 0|"gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930691|NCT01001221|P3|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930693|NCT01001221|P1|Participant Flow|Part 1: Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930694|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930695|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930696|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930697|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
931031|NCT01001104|O1|Outcome|LY 0.25 mg|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
951264|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
930698|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930699|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930700|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930701|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930702|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930703|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930704|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930705|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930706|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930707|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930708|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930709|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930710|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930711|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930712|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930713|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930714|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930715|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930716|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930717|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930718|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930719|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930720|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930901|NCT01001195|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930721|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930722|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930723|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930724|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930725|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930726|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930727|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930728|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930729|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930730|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930731|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930732|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930733|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930734|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930735|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930736|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930737|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930738|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930739|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930740|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930741|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930742|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930743|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930902|NCT01001195|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930744|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930745|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930746|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930747|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930748|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930749|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930750|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930751|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930752|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930753|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930754|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930755|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930756|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930757|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930758|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930759|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930760|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930761|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930762|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930763|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930764|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930765|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930766|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930903|NCT01001195|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930767|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930768|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930769|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930770|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930771|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930772|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930773|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930774|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930775|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930776|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930777|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930778|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930779|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930780|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930781|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930782|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930783|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930784|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930785|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930786|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930787|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930788|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930789|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930904|NCT01001195|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930790|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930791|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930792|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930793|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930794|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930795|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930796|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930797|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930798|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930799|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930800|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930801|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930802|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930803|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930804|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930805|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930806|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930807|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930808|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930809|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930810|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930811|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930812|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930905|NCT01001195|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930813|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930814|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930815|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930816|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930817|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930818|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930819|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930820|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930821|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930822|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930823|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930824|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930825|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930826|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930827|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930828|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930829|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930830|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930831|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930832|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930833|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930834|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930835|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930906|NCT01001195|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930836|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930837|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930838|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930839|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930840|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930841|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930842|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930843|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930844|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930845|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930846|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930847|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930848|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930849|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930850|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930851|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930852|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930853|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930854|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930855|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930856|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine MTD|"Cabazitaxel IV and gemcitabine IV on Day 1 then, gemcitabine IV on Day 8 at the maximum tolerated dose as determined in study part 1~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930857|NCT01001221|O4|Outcome|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930858|NCT01001221|O3|Outcome|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
931032|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931033|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
930859|NCT01001221|O2|Outcome|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930860|NCT01001221|O1|Outcome|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930861|NCT01001221|E4|Reported Event|Gemcitabine + Cabazitaxel Dose Level 0|"Gemcitabine 700 mg/m^2 IV followed by cabazitaxel 15 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930862|NCT01001221|E3|Reported Event|Cabazitaxel + Gemcitabine Dose Level -2|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 700 mg/m^2 IV on Day 1 then, gemcitabine 700 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930863|NCT01001221|E2|Reported Event|Cabazitaxel + Gemcitabine Dose Level -1|"Cabazitaxel 15 mg/m^2 IV followed by gemcitabine 900 mg/m^2 IV on Day 1 then, gemcitabine 900 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930864|NCT01001221|E1|Reported Event|Cabazitaxel + Gemcitabine Dose Level 0|"Cabazitaxel 20 mg/m^2 IV followed by gemcitabine 1000 mg/m^2 IV on Day 1 then, gemcitabine 1000 mg/m^2 IV on Day 8~21-day treatment cycles until disease progression or unacceptable toxicities, withdrawal of consent or Investigator's decision"
930865|NCT01001208|B3|Baseline|Total|Total of all reporting groups
930866|NCT01001208|B2|Baseline|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930867|NCT01001208|B1|Baseline|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930868|NCT01001208|P2|Participant Flow|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930869|NCT01001208|P1|Participant Flow|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930870|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930871|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930872|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930873|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930874|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
940133|NCT00980148|B3|Baseline|Total|Total of all reporting groups
930875|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930876|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930877|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930878|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930907|NCT01001195|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930879|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930880|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930881|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930882|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930883|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930884|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930885|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930886|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930887|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930888|NCT01001208|O2|Outcome|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930889|NCT01001208|O1|Outcome|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930890|NCT01001208|E2|Reported Event|Etanercept + Methotrexate|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received active methotrexate titrated as follows: 7.5 mg per week (3 capsules) for weeks 1 and 2, 10 mg per week (4 capsules) for weeks 3 and 4, and then up to 15 mg per week (6 capsules) or the maximum tolerated dose for the remainder of the 24-week treatment period.
930891|NCT01001208|E1|Reported Event|Etanercept + Placebo|Participants received 50 mg etanercept twice weekly (BIW) for the first 12 weeks and then 50 mg etanercept once weekly (QW) for the second 12 weeks. Participants also received oral placebo that was the same number of capsules per week as the methotrexate dosing regimen.
930892|NCT01001195|B5|Baseline|Total|Total of all reporting groups
931217|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
930893|NCT01001195|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930894|NCT01001195|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930895|NCT01001195|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930896|NCT01001195|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930897|NCT01001195|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930898|NCT01001195|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|One drop of AGN-210669 ophthalmic solution, 0.05% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930899|NCT01001195|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|One drop of AGN-210669 ophthalmic solution, 0.075% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
931034|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
951265|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
930908|NCT01001195|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.1%|One drop of AGN-210669 ophthalmic solution, 0.1% in both eyes each evening from Day 1 through the evening prior to Day 29. Selected sites: One additional drop in both eyes on Day 29.
930909|NCT01001169|B3|Baseline|Total|Total of all reporting groups
930910|NCT01001169|B2|Baseline|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930911|NCT01001169|B1|Baseline|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930912|NCT01001169|P2|Participant Flow|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930913|NCT01001169|P1|Participant Flow|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930914|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930915|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930916|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930917|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930918|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930919|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930920|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930921|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930922|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
942887|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
930923|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930924|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930925|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930926|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930927|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930928|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930929|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930930|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930931|NCT01001169|O1|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930932|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930933|NCT01001169|O3|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930934|NCT01001169|O2|Outcome|GSK2340274A_F1 6Y-9Y Subgroup|Healthy male or female Japanese children, between and including 6 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930935|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-5Y Subgroup|Healthy male or female Japanese children, between and including 6 months to 5 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930936|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930937|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930938|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930939|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930940|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930941|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931218|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
930942|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930943|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930944|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930945|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930946|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931035|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931036|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
930947|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930948|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930949|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930950|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930951|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930952|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930953|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930954|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930955|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930956|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930957|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930958|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931219|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931978|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
930959|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930960|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930961|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930962|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930963|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930964|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931037|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
930965|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930966|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930967|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930968|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930969|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930970|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930971|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930972|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930973|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930974|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930975|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930976|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930994|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931979|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
930977|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930978|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930979|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930980|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930981|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930982|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931001|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
951266|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
930983|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930984|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930985|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930986|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930987|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930988|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930989|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930990|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930991|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930992|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930993|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931220|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
930995|NCT01001169|O3|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
930996|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930997|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
930998|NCT01001169|O2|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
930999|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-35M Subgroup|Healthy male or female Japanese children, between and including 6 to 35 months of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule.
931000|NCT01001169|O4|Outcome|GSK2340274A_F1 3Y-9Y Subgroup|Healthy male or female Japanese children, between and including 3 to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931002|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
951267|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
931003|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931004|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931005|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931006|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931007|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931008|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931009|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931010|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931011|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931012|NCT01001169|O2|Outcome|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931094|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931095|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931013|NCT01001169|O1|Outcome|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931014|NCT01001169|E2|Reported Event|GSK2340274A_F2 10Y-17Y Group|Healthy male or female Japanese children, between and including 10 to 17 years of age, who received two doses of GSK2340274A vaccine (formulation 2), administered intramuscularly into the deltoid region of the arm, according to 0, 21-day schedule.
931015|NCT01001169|E1|Reported Event|GSK2340274A_F1 6M-9Y Group|Healthy male or female Japanese children, between and including 6 months to 9 years of age, who received two doses of GSK2340274A vaccine (formulation 1), administered intramuscularly into the deltoid region of the arm (intramuscularly into the anterolateral part of the thigh for subjects below 12 months of age at the entry of the study), according to 0, 21-day schedule. Within this group, enrolment of subjects was stratified by age into two subgroups, from 6 to 35 months and from 3 to 9 years.
931016|NCT01001104|B5|Baseline|Total|Total of all reporting groups
931017|NCT01001104|B4|Baseline|Placebo|Administered by SC injection, QW for 12 weeks.
931018|NCT01001104|B3|Baseline|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931019|NCT01001104|B2|Baseline|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931020|NCT01001104|B1|Baseline|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931021|NCT01001104|P4|Participant Flow|Placebo|Administered by SC injection, QW for 12 weeks.
931022|NCT01001104|P3|Participant Flow|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931023|NCT01001104|P2|Participant Flow|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931024|NCT01001104|P1|Participant Flow|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931025|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931026|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931027|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931028|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931029|NCT01001104|O3|Outcome|LY 0.75 mg|Administered by SC injection, QW for 12 weeks.
931030|NCT01001104|O2|Outcome|LY 0.50 mg|Administered by SC injection, QW for 12 weeks.
931038|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931039|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931040|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931041|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931042|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931043|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931044|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931045|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931046|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931047|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931048|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931049|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931050|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931051|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931052|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931053|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931054|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931055|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931056|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931057|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931058|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931059|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931060|NCT01001104|O4|Outcome|Placebo|Administered by SC injection, QW for 12 weeks.
931061|NCT01001104|O3|Outcome|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931062|NCT01001104|O2|Outcome|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931063|NCT01001104|O1|Outcome|0.75 mg LY2189265|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931064|NCT01001104|E4|Reported Event|0.75 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931065|NCT01001104|E3|Reported Event|0.5 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931066|NCT01001104|E2|Reported Event|0.25 mg LY2189265|Administered by SC injection, QW for 12 weeks.
931067|NCT01001104|E1|Reported Event|Placebo|Administered by subcutaneous (SC) injection, once weekly (QW) for 12 weeks.
931068|NCT01001078|B3|Baseline|Total|Total of all reporting groups
931096|NCT01001052|E2|Reported Event|Colcrys™ - Elderly Subjects (>60 Years Old)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
931097|NCT01001052|E1|Reported Event|Colcrys™ - Young Subjects (18-30 Years)|All subjects received a single dose of Colcrys™ (colchicine 1 x 0.6 mg) on Day 1 following an overnight fast.
931098|NCT01000974|B4|Baseline|Total|Total of all reporting groups
931221|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931069|NCT01001078|B2|Baseline|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
931070|NCT01001078|B1|Baseline|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
931071|NCT01001078|P2|Participant Flow|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
931072|NCT01001078|P1|Participant Flow|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
931103|NCT01000974|P2|Participant Flow|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931073|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
931074|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
931075|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
931076|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
931077|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
931078|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
931213|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931079|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
931080|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
931081|NCT01001078|O2|Outcome|LMA Supreme|Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.
931082|NCT01001078|O1|Outcome|I-Gel|Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.
931083|NCT01001078|O2|Outcome|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
931084|NCT01001078|O1|Outcome|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
931365|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931085|NCT01001078|E2|Reported Event|LMA Supreme|"Group in which the LMA Supreme will be used in the first and second attempts to secure the airway. If a third attempt is needed, the I-Gel will be used. If the third attempt fails, a standard endotracheal tube will be used.~The cuff of the LMA Supreme will be inflated with 25 mL of air and then by intervals of 5 mL until no leak is heard (max 45 mL). Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured at a cuff volume without audible leak and also at 45 mL. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O. Once the leak tests are done, the cuff will be deflated to initial volume necessary to avoid audible leaks."
931086|NCT01001078|E1|Reported Event|I-Gel|"Group in which the I-Gel will be used in the first and second attempts to secure the airway. If a third attempt is needed, the LMA Supreme will be used. If the third attempt fails, a standard endotracheal tube will be used.~Peak and mean airway pressure will be measured once the device is fixed with tape to the patient. Leak pressure will be measured as well. It will be done while closing the Adjustable Pressure Limiting valve and putting the fresh gas flow at 3 L/min. We will be looking at the manometer to see either a plateau (that would be a leak equal to the fresh gas flow) or the maximum allowed pressure 40 cm H2O."
931087|NCT01001052|B1|Baseline|Colcrys™ - Young Subjects and Colcrys™ - Elderly Subjects|"Colcrys™ (colchicine) - young subjects (18-30 years): All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.~Colcrys™ (colchicine) - Elderly subjects (≥60 years): All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours."
931088|NCT01001052|P2|Participant Flow|Colcrys™ (Colchicine) - Elderly Subjects (>60 Years)|All elderly subjects (≥ 60 years)received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931089|NCT01001052|P1|Participant Flow|Colcrys™ (Colchicine) - Young Subjects (18-30 Years)|All young subjects (18-30 years) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931090|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931091|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931092|NCT01001052|O2|Outcome|Colcrys™ (Colchicine) - Elderly Subjects ≥ 60 Years)|All older subjects (≥ 60 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931093|NCT01001052|O1|Outcome|Colcrys™ (Colchicine) - Young Subjects (18-30 Years Old)|All young subjects (18-30 years old) received a single oral dose of Colcrys™ (1 x 0.6 mg) on Day 1 following an overnight fast of at least 10 hours.
931980|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
931099|NCT01000974|B3|Baseline|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931100|NCT01000974|B2|Baseline|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931101|NCT01000974|B1|Baseline|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931102|NCT01000974|P3|Participant Flow|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
933693|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
931104|NCT01000974|P1|Participant Flow|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931105|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931106|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931107|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931108|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931109|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931214|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931215|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931216|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931110|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931111|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931112|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931113|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931125|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
951268|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
931114|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931115|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931116|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931117|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931118|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931119|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931120|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931121|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931122|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931123|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931124|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931126|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931127|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931128|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931129|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931130|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931131|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931132|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931133|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931134|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally
931135|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931136|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931137|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931138|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931139|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931140|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931141|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931142|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931143|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931144|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931145|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931146|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931158|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
934589|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
931147|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931148|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931149|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931150|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931151|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931152|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931153|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931154|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931155|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally
931156|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931157|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931159|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931160|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931161|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931162|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931163|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931164|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931165|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931166|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931167|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931168|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931169|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931170|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931171|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931172|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931173|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931174|NCT01000974|O3|Outcome|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931175|NCT01000974|O2|Outcome|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931176|NCT01000974|O1|Outcome|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931177|NCT01000974|E3|Reported Event|Pentacel Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of Pentacel® vaccine co-administered with 3 doses of Prevnar13® vaccine, 2 or 3 doses of Engerix™-B vaccine at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Pentacel® vaccine was administered intramuscularly in the right thigh. The Engerix™-B vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally. If subjects in the Pentacel Group had received a birth dose of Hepatitis B vaccine then they were to receive Engerix™-B vaccine only at 2 and 6 months of age.
931178|NCT01000974|E2|Reported Event|ActHIB Group|Subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of ActHIB® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The ActHIB® vaccine was administered intramuscularly in the right thigh. The Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931179|NCT01000974|E1|Reported Event|Hiberix Group|Pooled group of subjects, male or female between, and including, 6 and 12 weeks of age at the time of the first vaccination, who received 3 doses of 3 different lots of Hiberix® vaccine co-administered with 3 doses of Pediarix® and Prevnar13® vaccines at 2, 4 and 6 months of age and 2 doses of Rotarix® vaccine at 2 and 4 months of age. The Hiberix® vaccine was administered intramuscularly in the right thigh. Pediarix® vaccine was administered intramuscularly in the left thigh. The Prevnar13® vaccine was administered intramuscularly in the left thigh or deltoid. The Rotarix® vaccine was administered orally.
931180|NCT01000961|B1|Baseline|RP103 and Cystagon® Crossover|Per Protocol Population
931181|NCT01000961|P2|Participant Flow|Cystagon First, Then RP103, Then Cystagon|RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in first intervention (after Run-in period) and Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in second intervention period.
931363|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
951269|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
931182|NCT01000961|P1|Participant Flow|Cystagon First, Then Cystagon, Then RP103|Cystagon® dose in 50 mg and 150 mg capsule formulations administered every 6 hours in first intervention (after Run-in period) and RP103 dose in 25 mg and 75 mg capsule formulations administered every 12 hours in second intervention period.
931183|NCT01000961|O2|Outcome|RP103|Per Protocol Population
931184|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
931185|NCT01000961|O2|Outcome|RP103|Per Protocol Population
931186|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
931187|NCT01000961|O2|Outcome|RP103|Per Protocol Population
931188|NCT01000961|O1|Outcome|Cystagon®|Per Protocol Population
931189|NCT01000961|O2|Outcome|Cystagon®|Per Protocol Population
931190|NCT01000961|O1|Outcome|RP103|Per Protocol Population
931191|NCT01000961|E2|Reported Event|Cystagon®|Safety population during treatment periods
931192|NCT01000961|E1|Reported Event|RP103|Safety Population during treatment periods
931193|NCT01000818|B1|Baseline|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
931194|NCT01000818|P1|Participant Flow|Raltegravir/Famotidine/Omeprazole|"Period 1 - 400 mg Raltegravir x 1 day~Period 2 - 20 mg Famotidine + 400 mg Raltegravir x 1 day~Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5 days"
931195|NCT01000818|O3|Outcome|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
931196|NCT01000818|O2|Outcome|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
931197|NCT01000818|O1|Outcome|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
931198|NCT01000818|E4|Reported Event|20 mg Omeprazole + 400 mg Raltegravir|Period 3 - 20 mg Omeprazole + 400 mg Raltegravir x 5days
931199|NCT01000818|E3|Reported Event|20 mg Famotidine + 400 mg Raltegravir|Period 2 - 20 mg Famotidine + 400 mg Raltegravir
931200|NCT01000818|E2|Reported Event|400 mg Raltegravir|Period 1 - 400 mg Raltegravir
931201|NCT01000818|E1|Reported Event|Prestudy|
931202|NCT01000805|B3|Baseline|Total|Total of all reporting groups
931203|NCT01000805|B2|Baseline|Placebo|Participants received placebo QD, po for 8 weeks.
931204|NCT01000805|B1|Baseline|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931205|NCT01000805|P2|Participant Flow|Placebo|Participants received placebo QD, po for 8 weeks.
931206|NCT01000805|P1|Participant Flow|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931207|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931208|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931209|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931210|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931211|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931212|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
931222|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931223|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931224|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931225|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931226|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931227|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931228|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931229|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931230|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931231|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931232|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD, po for 7 weeks.
931233|NCT01000805|O2|Outcome|Placebo|Participants received placebo QD, po for 8 weeks.
931234|NCT01000805|O1|Outcome|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931235|NCT01000805|E2|Reported Event|Placebo|Participants received placebo QD, po for 8 weeks.
931236|NCT01000805|E1|Reported Event|Duloxetine|Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
931237|NCT01000662|B3|Baseline|Total|Total of all reporting groups
931238|NCT01000662|B2|Baseline|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931239|NCT01000662|B1|Baseline|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931240|NCT01000662|P2|Participant Flow|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931241|NCT01000662|P1|Participant Flow|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931242|NCT01000662|O2|Outcome|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931243|NCT01000662|O1|Outcome|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931244|NCT01000662|E2|Reported Event|ARM 2 Weekly Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931272|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931273|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931981|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
931245|NCT01000662|E1|Reported Event|ARM 1 Daily Boost|"Radiation Therapy~Radiation Therapy: Arm 1= 15 daily radiation fractions of 2.7 Gy, Monday to Friday for 3 weeks, to the whole breast with a daily concomitant boost of 0.5 Gy to the tumor bed, for a total daily dose of 3.2 Gy to the tumor bed (2.7Gy+0.5 Gy). The overall dose will be 40.5 Gy to the breast and 48.0 Gy to the tumor bed.~Arm 2= 15 daily radiation fractions of 2.7 Gy Monday to friday for three weeks to the entire breast with a Friday boost of 2.0 Gy to the tumor bed, for a total dose to the tumor bed on each friday of 4.7 Gy (2.7 Gy+ 2.0 Gy). The overall dose will be 40.5 Gy to the breast and 46.5 gy to the tumor bed."
931246|NCT01000649|B5|Baseline|Total|Total of all reporting groups
931247|NCT01000649|B4|Baseline|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931248|NCT01000649|B3|Baseline|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931249|NCT01000649|B2|Baseline|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931250|NCT01000649|B1|Baseline|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931251|NCT01000649|P4|Participant Flow|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931252|NCT01000649|P3|Participant Flow|FE 202158 3.75|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 3.75 ng/kg/min.The two patients randomized to FE 202158 3.75 ng group were excluded from the efficacy evaluation since meaningful analyses were not possible.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931253|NCT01000649|P2|Participant Flow|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931254|NCT01000649|P1|Participant Flow|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931255|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931256|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931257|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931258|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931259|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931260|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931261|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931262|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931263|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931264|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931265|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931266|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931267|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931268|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931269|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931270|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931271|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931274|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931275|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931276|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931277|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931278|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931279|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931280|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931281|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931282|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931283|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931284|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931285|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931286|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931287|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931288|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931289|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931290|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931291|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931292|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931293|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931294|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931295|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931296|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931297|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931298|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931299|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931300|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931301|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931593|NCT00999661|E1|Reported Event|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
931302|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931303|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931304|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931305|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931306|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931307|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931308|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931309|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931310|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931311|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931312|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931313|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931314|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931315|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931316|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931317|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931318|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931319|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931320|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931321|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931322|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931323|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931324|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931325|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931326|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931327|NCT01000649|O3|Outcome|PLCBO|Patients in the arm received an intravenous infusion for up to 7 days of placebo.
931897|NCT00999167|B3|Baseline|Total|Total of all reporting groups
931328|NCT01000649|O2|Outcome|FE 202158 2.5|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 2.5 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931329|NCT01000649|O1|Outcome|FE 202158 1.25|"Patients in the arm received an intravenous infusion for up to 7 days of FE 202158 at an initial rate of 1.25 ng/kg/min.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931330|NCT01000649|E4|Reported Event|PLCBO|Patients in the arm received a continuous intravenous infusion of isotonic saline up to seven consecutive days.
931331|NCT01000649|E3|Reported Event|FE 202158 3.75|"Patients in the arm received a continuous intravenous infusion of FE 202158 3.75 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931332|NCT01000649|E2|Reported Event|FE 202158 2.5|"Patients in the arm received a continuous intravenous infusion of FE 202158 2.5 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931333|NCT01000649|E1|Reported Event|FE 202158 1.25|"Patients in the arm received a continuous intravenous infusion of FE 202158 1.25 ng/kg/min up to seven consecutive days.~FE 202158 was provided as an isotonic acetate buffered stock solution of pH 4.0 in vials appropriately diluted with isotonic saline prior to use."
931334|NCT01000610|B1|Baseline|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
931364|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931614|NCT00999544|O2|Outcome|Aprepitant 40 mg - Placebo|All subjects received exposure to this study condition once.
931335|NCT01000610|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenous (iv) infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (less than or equal to [≤] 10 milligrams per day (mg/day) prednisone or equivalent) or intra-articular corticosteroids, non-steroid anti-inflammatory drugs (NSAIDs) and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone100 mg iv prior to each rituximab infusion.
931336|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
931337|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
931338|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
931339|NCT01000610|O1|Outcome|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
931340|NCT01000610|E1|Reported Event|Rituximab|Participants received rituximab 1000 mg iv infusion on Days 1 and 15 along with methotrexate 10-25 mg weekly, orally or parenterally. Participants could receive concomitant treatment with corticosteroids (≤ 10 mg/day prednisone or equivalent) or intra-articular corticosteroids, NSAIDs and analgesics throughout the study period at the discretion of the investigator. All participants received methylprednisolone 100 mg iv prior to each rituximab infusion.
931341|NCT01000506|B5|Baseline|Total|Total of all reporting groups
931342|NCT01000506|B4|Baseline|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931343|NCT01000506|B3|Baseline|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931344|NCT01000506|B2|Baseline|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931345|NCT01000506|B1|Baseline|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931346|NCT01000506|P4|Participant Flow|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931347|NCT01000506|P3|Participant Flow|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931348|NCT01000506|P2|Participant Flow|Mepolizumab 75 mg IV|Participants received mepolizumab 75 milligrams (mg) IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931349|NCT01000506|P1|Participant Flow|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931350|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931351|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931352|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931353|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931354|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931355|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931356|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931357|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931358|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931359|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931360|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931361|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931362|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931366|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931367|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931368|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931369|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931370|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931371|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931372|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931373|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931374|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931375|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931376|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931377|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931378|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931379|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931380|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931381|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931382|NCT01000506|O4|Outcome|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931383|NCT01000506|O3|Outcome|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931384|NCT01000506|O2|Outcome|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931385|NCT01000506|O1|Outcome|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931386|NCT01000506|E4|Reported Event|Mepolizumab 750 mg IV|Participants received mepolizumab 750 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931387|NCT01000506|E3|Reported Event|Mepolizumab 250 mg IV|Participants received mepolizumab 250 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931388|NCT01000506|E2|Reported Event|Mepolizumab 75 mg IV|Participants received mepolizumab 75 mg IV infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931898|NCT00999167|B2|Baseline|Placebo|6 mL BID
931899|NCT00999167|B1|Baseline|HPN-100|6 mL BID
931389|NCT01000506|E1|Reported Event|Placebo IV|Participants received placebo intravenous (IV) infusion every 4 weeks for 48 weeks (giving 52 weeks of exposure to investigational product).
931390|NCT01000480|B1|Baseline|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
931391|NCT01000480|P1|Participant Flow|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
931406|NCT01000376|E1|Reported Event|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931407|NCT01000337|B3|Baseline|Total|Total of all reporting groups
931997|NCT00999037|B3|Baseline|Total|Total of all reporting groups
931392|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
931393|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
931394|NCT01000480|O1|Outcome|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
931395|NCT01000480|E1|Reported Event|Pemetrexed, Cisplatin, and Thoracic Radiotherapy|"Induction phase (2 cycles). Pemetrexed: 500 milligrams per square meter (mg/m²) intravenous infusion on Day 1 of 21-day cycle. Cisplatin: 75 mg/m² intravenous infusion on Day 1 of 21-day cycle.~Participants eligible for concurrent phase (2 more cycles of pemetrexed-cisplatin treatment and radiotherapy) if they had complete response, partial response, or stable disease (Response Evaluation Criteria in Solid Tumors guidelines), total lung volume receiving more than 20 gray (Gy) ≤35% (dose volume histogram), 0 or 1 Eastern Cooperative Oncology Group performance status, no residual neurological toxicity >Grade 2 (Common Terminology Criteria for Adverse Events).~Thoracic Radiotherapy: 2 Gy/fraction after completion of pemetrexed and cisplatin infusions on Day 1 of Cycle 3 and continued daily (5 days per week) until total delivered dose was 66 Gy, over approximately 7 weeks.~Folic acid, Vitamin B12 supplements, and prophylactic dexamethasone administered per approved pemetrexed label."
931396|NCT01000376|B3|Baseline|Total|Total of all reporting groups
931397|NCT01000376|B2|Baseline|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931500|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931398|NCT01000376|B1|Baseline|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931399|NCT01000376|P2|Participant Flow|Eribulin Plus Ketoconazole First, Then Eribulin Alone|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931400|NCT01000376|P1|Participant Flow|Eribulin Alone First, Then Eribulin Plus Ketoconazole|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931401|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931402|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931403|NCT01000376|O2|Outcome|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931404|NCT01000376|O1|Outcome|Eribulin Alone|Eribulin IV 1.4 mg/m^2 alone on Day 1, then eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931405|NCT01000376|E2|Reported Event|Eribulin Plus Ketoconazole|Eribulin IV 0.7 mg/m^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m^2 alone on Day 15 of a 28 day cycle. Subsequently, subjects were able to receive eribulin 1.4 mg/m^2 on Days 1 and 8 every 21 days.
931429|NCT01000311|P2|Participant Flow|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931408|NCT01000337|B2|Baseline|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
931409|NCT01000337|B1|Baseline|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
931410|NCT01000337|P2|Participant Flow|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
931411|NCT01000337|P1|Participant Flow|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
931412|NCT01000337|O2|Outcome|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
931413|NCT01000337|O1|Outcome|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
931414|NCT01000337|E2|Reported Event|Propofol|"Intravenous anesthetic suitable for induction and maintainance of general anesthesia. Anaesthesia is induced by administereing intravenously 2-2.5 mg/kg body weight and maintained by continuous intravenous infusion of 6 mg/kg/hour of propofol by means of an electric infusion pump.~The depth of anesthesia during propofol anesthesia is monitored by the bispectral index monitoring. The effect of propofol on the liver for the predetermined clinically applicable concentrations was evaluated."
931415|NCT01000337|E1|Reported Event|Sevoflurane|Volatile anesthetic used to induce and maintain general anaeshesia. To induce anaesthesia the inspired concentration recommended is 8% in oxyfen to maintain anaesthesia the inspired concentration is 1-2%. The drug is administered continuously during surgery using a specially designed vaporizer. The depth of anesthesia obtained during sevoflurane administration is monitored by the end expired concentration of sevoflurane and by the bispectral index monitoring. The effect of sevoflurane on the liver for the predetermined clinically applicable concentrations was evaluated.
931416|NCT01000324|B1|Baseline|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931417|NCT01000324|P1|Participant Flow|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931418|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
931419|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule.
931420|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931421|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931422|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931423|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931424|NCT01000324|O1|Outcome|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931425|NCT01000324|E1|Reported Event|Twinrix Group|Pooled group of subjects from groups who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
931426|NCT01000311|B3|Baseline|Total|Total of all reporting groups
931427|NCT01000311|B2|Baseline|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931428|NCT01000311|B1|Baseline|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931457|NCT01000285|B3|Baseline|Total|Total of all reporting groups
931430|NCT01000311|P1|Participant Flow|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931431|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931432|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931433|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931434|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931435|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931436|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931437|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931438|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931439|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931440|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931441|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931442|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931443|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931444|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931445|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931501|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931446|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931447|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931448|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931449|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931450|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931451|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931452|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931453|NCT01000311|O2|Outcome|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931454|NCT01000311|O1|Outcome|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931455|NCT01000311|E2|Reported Event|Routine Vaccines|Infants received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months.
931456|NCT01000311|E1|Reported Event|MenACWY-CRM + Routine Vaccines|"Infants received 3 doses of MenACWY-CRM at 2, 4 and 6 months as a infant series vaccination and a toddler dose at 12 months.~Infants also received routine vaccines - 3 doses each of DTaP-IPV/Hib, HBV and PCV at 2, 4 and 6 months; and 1 dose each of PCV and MMR at 12 months."
931458|NCT01000285|B2|Baseline|Lymphoma ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931459|NCT01000285|B1|Baseline|Acute ATLL|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931460|NCT01000285|P1|Participant Flow|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931461|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931462|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931463|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
931464|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
931465|NCT01000285|O8|Outcome|Patient D (Non-responder) Post-Therapy|
931466|NCT01000285|O7|Outcome|Patient D (Non-responder) Pre-Therapy|
931467|NCT01000285|O6|Outcome|Patient C (Non-responder) Post-Therapy|
931468|NCT01000285|O5|Outcome|Patient C (Non-responder) Pre-Therapy|
931469|NCT01000285|O4|Outcome|Patient B (Responder) Post-Therapy|
931470|NCT01000285|O3|Outcome|Patient B (Responder) Pre-Therapy|
931471|NCT01000285|O2|Outcome|Patient A (Responder) Post-Therapy|
931472|NCT01000285|O1|Outcome|Patient A (Responder) Pre-Therapy|
931473|NCT01000285|O2|Outcome|Non-responders|Patients who had stable or progressive disease after treatment.
931474|NCT01000285|O1|Outcome|Responders|Patients who had a complete or partial response to treatment
931475|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931591|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
931476|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931477|NCT01000285|O1|Outcome|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931478|NCT01000285|E1|Reported Event|EPOCH Chemotherapy & Bortezomib|"Bortezomib 1.0 mg/m2 IV Days 1-4~Etoposide 50 mg/m2/d 96 hour CIVI on Days 1-4~Vincristine 0.4 mg/m2/d 96 hour CIVI on Days 1-4~Doxorubicin 10 mg/m2/d 96 hour CIVI on Days 1-4~Prednisone 60 mg/m2/d PO on Days 1-5~Cyclophosphamide 375 mg/m2 IV on Day 5~Raltegravir 400 mg PO BID every day starting with cycle 2 therapy for the entire duration of the cycle.~Cycles will be repeated every 21-28 days for 2 cycles beyond best response, or a maximum of 6 cycles."
931479|NCT01000155|B1|Baseline|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
931480|NCT01000155|P1|Participant Flow|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
931481|NCT01000155|O1|Outcome|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
931482|NCT01000155|E1|Reported Event|Vorinostat|Patients received vorinostat in a pulsed fashion, once a day for 3 consecutive days every week to a maximum dose of 400 mg per dose (1200 mg/wk), for 12 to 16 weeks at the maximum dose. The first 3 patients were enrolled in an intrapatient dose escalation schedule of 100 mg/d, then 200 mg/d, each for 3 consecutive days a week for 4 weeks, and then 400 mg/d, 3 consecutive days per week for 16 weeks. The last 2 patients were enrolled to receive 400 mg/d, 3 consecutive days per week for 12 weeks, without an initial dose escalation.
931483|NCT01000064|B1|Baseline|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
931484|NCT01000064|P2|Participant Flow|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
931485|NCT01000064|P1|Participant Flow|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
931486|NCT01000064|O2|Outcome|Placebo First, Then Vyvanse|"Drug: Placebo Capsules taken for 42 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days."
931487|NCT01000064|O1|Outcome|Vyvanse First, Then Placebo|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
931488|NCT01000064|O1|Outcome|All Participants|"Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.~Procedure/Surgery: fMRI Brain scans (fMRI) performed 3 times.~Drug: Placebo Capsules taken for 42 days."
931489|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931490|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931491|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931492|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931493|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931494|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931495|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931496|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931497|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931498|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931499|NCT01000064|O2|Outcome|Placebo|"Placebo: Placebo capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931502|NCT01000064|O1|Outcome|Vyvanse|"Vyvanse: 30 mg - 70 mg capsules taken every morning for 6 weeks.~fMRI: Brain scans (fMRI) performed at baseline, 6 week visit and 12th week visit."
931503|NCT01000064|E2|Reported Event|Placebo|Placebo capsule Taken for 42 days.
931504|NCT01000064|E1|Reported Event|Vyvanse|Drug: Vyvanse 30 mg for 7 days. 50 mg for 7 days. 70 mg for 28 days.
931505|NCT01000025|B3|Baseline|Total|Total of all reporting groups
931506|NCT01000025|B2|Baseline|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931507|NCT01000025|B1|Baseline|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931508|NCT01000025|P2|Participant Flow|Placebo|Control arm
931509|NCT01000025|P1|Participant Flow|PF-804|Study treatment arm
931510|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931511|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931512|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931513|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931514|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931515|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931516|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931610|NCT00999544|O6|Outcome|Placebo- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
931517|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931518|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931519|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931520|NCT01000025|O2|Outcome|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931521|NCT01000025|O1|Outcome|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931522|NCT01000025|E2|Reported Event|Placebo|"Patients receive oral placebo once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~Placebo: Placebo 45 mg PO, daily"
931523|NCT01000025|E1|Reported Event|PF-00299804|"Patients receive oral PF-00299804 once daily. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~PF-00299804: PF-804 45 mg PO, daily"
931524|NCT00999921|B3|Baseline|Total|Total of all reporting groups
931525|NCT00999921|B2|Baseline|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg daily for 3 months
931526|NCT00999921|B1|Baseline|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily ffrom 5th day to 25 th day of menstrual cycle for 3 months
931527|NCT00999921|P2|Participant Flow|Evening Primrose Oil|Evening Primrose Oil 1000 mg daily for 3 months
931528|NCT00999921|P1|Participant Flow|Tamoxifen|Tamoxifen 10 mg OD from 5th day to 25th day of menstrual cycle for 3 months
931529|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
931530|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen was administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
931531|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil was administered at a dose of 1000 mg once daily for 3 months
931532|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen administered at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
931533|NCT00999921|O2|Outcome|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
931534|NCT00999921|O1|Outcome|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
931535|NCT00999921|E2|Reported Event|Evening Primrose Oil|Evening Primrose Oil at a dose of 1000 mg once daily for 3 months
931536|NCT00999921|E1|Reported Event|Tamoxifen|Tamoxifen at a dose of 10 mg once daily from 5th day to 25th day of menstrual cycle for 3 months
931537|NCT00999908|B1|Baseline|Entire Study Population|The entire study population includes the 3 groups of patients who received indacaterol 150 μg, tiotropium 18 μg, and placebo (matching indacaterol) once each in 1 of 3 different orders in this crossover study. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931538|NCT00999908|P3|Participant Flow|Placebo-indacaterol 150 μg-tiotropium 18 μg|Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931592|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
931974|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
931539|NCT00999908|P2|Participant Flow|Tiotropium 18 μg-placebo-indacaterol 150 μg|Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931540|NCT00999908|P1|Participant Flow|Indacaterol 150 μg-tiotropium 18 μg-placebo|Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931541|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931542|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931543|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931544|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931545|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931546|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931547|NCT00999908|O3|Outcome|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931548|NCT00999908|O2|Outcome|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931611|NCT00999544|O5|Outcome|Placebo- 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
931549|NCT00999908|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931550|NCT00999908|E3|Reported Event|Placebo|Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931551|NCT00999908|E2|Reported Event|Tiotropium 18 μg|Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931552|NCT00999908|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
931553|NCT00999830|B3|Baseline|Total|Total of all reporting groups
931554|NCT00999830|B2|Baseline|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931555|NCT00999830|B1|Baseline|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931556|NCT00999830|P2|Participant Flow|Arm B: IPH2101 2mg/kg|IPH2101 Fully human anti-KIR monoclonal antibody : 2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
931557|NCT00999830|P1|Participant Flow|Arm A: IPH2101 0.2mg/Kg|IPH2101 Fully human anti-KIR monoclonal antibody : 0.2mg/Kg , every 4 weeks by intravenous route over 1 hour, for 4 cycles. Patients responding at 4 months will be allowed to receive an additional period of treatment of 4 monthly.
931558|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931559|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931560|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931561|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931562|NCT00999830|O2|Outcome|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931563|NCT00999830|O1|Outcome|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931564|NCT00999830|E2|Reported Event|Arm B: IPH2101 2mg/kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931565|NCT00999830|E1|Reported Event|Arm A: IPH2101 0.2mg/Kg|every 4 weeks by intravenous route over 1 hour, for 4 or up to 8 cycles.
931566|NCT00999804|B3|Baseline|Total|Total of all reporting groups
931567|NCT00999804|B2|Baseline|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931568|NCT00999804|B1|Baseline|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931569|NCT00999804|P2|Participant Flow|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931570|NCT00999804|P1|Participant Flow|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931571|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931572|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931573|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931574|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931575|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931576|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931612|NCT00999544|O4|Outcome|Placebo- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
931613|NCT00999544|O3|Outcome|Aprepitant 200 mg- Placebo|All subjects received exposure to this study condition once.
931577|NCT00999804|O2|Outcome|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931578|NCT00999804|O1|Outcome|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931579|NCT00999804|E2|Reported Event|12-week Arm|"Participants will receive 12-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931580|NCT00999804|E1|Reported Event|24-week Arm|"Participants will receive 24-weeks of lapatinib plus trastuzumab. Participants who are estrogen receptor (ER) and/or progesterone receptor (PR) positive will also receive endocrine therapy.~Lapatinib: 1000 mg by mouth daily~Letrozole: 2.5 mg by mouth daily (for hormone receptor positive participants only)~Trastuzumab: 6 mg/kg intravenously, every 3 weeks"
931581|NCT00999687|B1|Baseline|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks.
931582|NCT00999687|P1|Participant Flow|All Participants (Indigo Naturalis Oil Extract /Olive Oil)|In all participants, indigo naturalis oil extract (INOE) was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and INOE was applied to both hands twice daily for another 12 weeks.
931583|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then transfer to Indigo Naturalis Oil Extract from week 13 to week 24
931584|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
931585|NCT00999687|O2|Outcome|Control Group|Using Olive Oil from week 0 to week 12, then change to Indigo Naturalis Oil Extract (INOE) from week 13 to week 24.
931586|NCT00999687|O1|Outcome|Experimental Group|Using Indigo Naturalis Oil Extract (INOE) from week 0 to week 24.
931587|NCT00999687|E1|Reported Event|All Participants (Indigo Naturalis Oil Extreact/Olive Oil)|"Experimental group: randomized to receive Indigo Naturalis Oil Extract first; Control group: randomized to receive Olive Oil first.~In all participants, indigo naturalis oil extract was applied to the fingernails of one bilateral hand (experimental group) and olive oil was applied to the fingernails of the contralateral hand (control group) twice daily for 12 weeks. The randomization process was conducted by block randomization method with 1:1 ratio. After 12 weeks, olive oil treatment was discontinued and indigo naturalis oil extract was applied to both hands twice daily for another 12 weeks."
931588|NCT00999661|B1|Baseline|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
931589|NCT00999661|P1|Participant Flow|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
931590|NCT00999661|O1|Outcome|Realize Adjustable Gastric Band-C|All subjects implanted with the Realize Gastric Band-C.
931975|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
931594|NCT00999596|B1|Baseline|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
931595|NCT00999596|P1|Participant Flow|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
931596|NCT00999596|O2|Outcome|FFDM Mammograms Score = Fail|Mammogram sets from the Philips Digital System with Fail score for Image Quality
931597|NCT00999596|O1|Outcome|FFDM Mammograms Score = Pass|Mammogram sets from the Philips Digital System with Pass score for Image Quality
931598|NCT00999596|E1|Reported Event|FFDM (Full Field Digital Mammography)|Mammograms from the Philips Digital System
931599|NCT00999544|B1|Baseline|Crossover Within Subject|All subjects were exposed to every condition.
931600|NCT00999544|P1|Participant Flow|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. During each of 15 separate test sessions, subjects received pretreatment with aprepitant (0, 40 or 200 mg) followed by a single challenge with a oxycodone (15 or 30, intranasal; 20 or 40 mg) or placebo. The fifteen dose conditions were administered in random order and each subject was exposed to each dose combination once.
931601|NCT00999544|O15|Outcome|Aprepitant 200 mg- 40 Oxycodone Oral|All subjects received exposure to this study condition once.
931602|NCT00999544|O14|Outcome|Aprepitant 200 mg- 20 Oxycodone Oral|All subjects received exposure to this study condition once.
931603|NCT00999544|O13|Outcome|Aprepitant 200 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
931604|NCT00999544|O12|Outcome|Aprepitant 200 mg - 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
931605|NCT00999544|O11|Outcome|Aprepitant 40 mg - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
931606|NCT00999544|O10|Outcome|Aprepitant 40 mg- 20 mg Oxycodone Oral|All subjects received exposure to this study condition once.
931607|NCT00999544|O9|Outcome|Aprepitant 40 mg - 30 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
931608|NCT00999544|O8|Outcome|Aprepitant 40 mg- 15 mg Oxycodone Intranasal|All subjects received exposure to this study condition once.
931609|NCT00999544|O7|Outcome|Placebo - 40 mg Oxycodone Oral|All subjects received exposure to this study condition once.
931998|NCT00999037|B2|Baseline|Placebo|Placebo: 1 inert tablet tid x 12 weeks
931615|NCT00999544|O1|Outcome|Placebo-Placebo (in and po)|All subjects received exposure to this study condition once.
931616|NCT00999544|E1|Reported Event|Within-subject Crossover Design|All subjects received exposure to every study condition in random order. This was not a parallel group design.
931617|NCT00999466|B4|Baseline|Total|Total of all reporting groups
931618|NCT00999466|B3|Baseline|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931619|NCT00999466|B2|Baseline|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931620|NCT00999466|B1|Baseline|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931621|NCT00999466|P3|Participant Flow|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931622|NCT00999466|P2|Participant Flow|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931623|NCT00999466|P1|Participant Flow|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931624|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931625|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931626|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931627|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931628|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931629|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931630|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931631|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931632|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931633|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931634|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931635|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931636|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931637|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931638|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931639|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931640|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931641|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931642|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931643|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931644|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931645|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931646|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931647|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931648|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931649|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931650|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931651|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931652|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931653|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931654|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931655|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931656|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931657|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931658|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931659|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931660|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931661|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931662|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931663|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931664|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931665|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931666|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931667|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931668|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931669|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931670|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931671|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931672|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931673|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931674|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931675|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931676|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931677|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931678|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931679|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931680|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931681|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931682|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931683|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931684|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931685|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931686|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931687|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931688|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931689|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931690|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931691|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931692|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931693|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931694|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931695|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931696|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931697|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931698|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931699|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931700|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931701|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931702|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931703|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931704|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931705|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931706|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931707|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931708|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931709|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931710|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931711|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931712|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931713|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931714|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931715|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931716|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931717|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931718|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931719|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931720|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931721|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931722|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931723|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931724|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931725|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931726|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931727|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931728|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931729|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931730|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931731|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931732|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931733|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931734|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931735|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931736|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931737|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931738|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931739|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931740|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931741|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931742|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931743|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931744|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931745|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931746|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931976|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
931747|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931748|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931749|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931750|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931751|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931752|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931753|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931754|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931755|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931756|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931757|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931758|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931759|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931760|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931761|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931762|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931763|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931764|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
951270|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
931765|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931766|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931767|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931768|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931769|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931770|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931771|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931772|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931773|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931774|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931775|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931776|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931777|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931778|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931779|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931780|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931781|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931782|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931783|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931784|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931785|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931786|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931787|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931788|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931789|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931790|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931791|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931792|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931793|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931794|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931795|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931796|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931797|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931798|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931799|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931800|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931801|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931802|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931803|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931804|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931805|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931806|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931807|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931808|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931809|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931810|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931811|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931812|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931813|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931814|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931815|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931816|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931817|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931818|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931819|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931820|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931821|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931822|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931823|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931824|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931825|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931826|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931827|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931828|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931829|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931830|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931831|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931832|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931833|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931834|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931835|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931836|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931837|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931838|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931839|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931840|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931841|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931842|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931843|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931844|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931845|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931846|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931847|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931848|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931849|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931850|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931851|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931852|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931853|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931854|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931855|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931856|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931857|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931858|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931859|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931860|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931861|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931862|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931863|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931864|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931865|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931866|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931867|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931868|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931869|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931870|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931871|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931872|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931873|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931874|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931875|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931876|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931877|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931878|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931879|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931880|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931881|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931882|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931883|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931884|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931885|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931886|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931887|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931888|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931889|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931890|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931891|NCT00999466|O3|Outcome|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931892|NCT00999466|O2|Outcome|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931893|NCT00999466|O1|Outcome|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931894|NCT00999466|E3|Reported Event|Placebo|Placebo nasal spray, one spray in the left nostril (Pilot part) or per nostril (Main part) once weekly.
931895|NCT00999466|E2|Reported Event|AZD8848, 60 μg|AZD8848 nasal spray, 60 μg, one spray of 30 μg per nostril once weekly. Main part.
931896|NCT00999466|E1|Reported Event|AZD8848, 30 μg|AZD8848 nasal spray, 30 μg, one spray in the left nostril once weekly. Pilot part.
931900|NCT00999167|P3|Participant Flow|Placebo|Subjects will receive 6 mL BID placebo for 16 weeks (Part B)
931901|NCT00999167|P2|Participant Flow|HPN-100 6 mL|Subjects will receive 6 mL BID HPN-100 for 16 weeks (Part B)
931902|NCT00999167|P1|Participant Flow|HPN-100 6 mL and 9 mL|Subjects will undergo a one step dose escalation over 4 weeks. Subjects will initially receive 6 mL HPN-100 BID for 1 week. On Day 7 and following a satisfactory safety assessment of the subject, the dose will be escalated to 9 mL BID for an additional 3 weeks.
931903|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
931904|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
931905|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
931906|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
931907|NCT00999167|O2|Outcome|Placebo|Placebo 6 mL BID (Part B)
931908|NCT00999167|O1|Outcome|HPN-100|HPN-100 6 mL BID (Part B)
931909|NCT00999167|O2|Outcome|Placebo|6 mL BID
931910|NCT00999167|O1|Outcome|HPN-100|6 mL BID
931911|NCT00999167|O1|Outcome|HPN-100 BID|6 mL or 9 mL BID HPN-100 (Part A)
931912|NCT00999167|E3|Reported Event|Part B: Placebo|Matching HPN-100 placebo, 6 mL BID
931913|NCT00999167|E2|Reported Event|Part B: HPN-100|6 mL BID, equivalent to approximately 13.2 grams of HPN-100/day
931914|NCT00999167|E1|Reported Event|Part A: HPN-100|6 mL BID for 7 days followed by 9 mL BID for 21 days, equivalent to approximately 13.2 and 19.8 grams of HPN-100/day, respectively
931915|NCT00999141|B1|Baseline|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
931999|NCT00999037|B1|Baseline|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
932000|NCT00999037|P2|Participant Flow|Placebo|Placebo (inert tablets): 1 tablet TID with meals for 12 weeks
931916|NCT00999141|P1|Participant Flow|Facelift Participants|One side of face will be treated with the investigational product (FS VH S/D 4 s-apr) as an adjuvant to the standard of care (SoC), and the other side of the face will receive SoC alone. Please note: Each subject will participate in both arms (investigational product and SoC) simultaneously, and will serve as his/her own control.
931917|NCT00999141|O2|Outcome|Related Facial Adverse Events|
931918|NCT00999141|O1|Outcome|Related Non-Facial Adverse Events|
931919|NCT00999141|O4|Outcome|SoC Side - Seroma|
931920|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Seroma|
931921|NCT00999141|O2|Outcome|SoC Side - Hematoma|
931922|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
931923|NCT00999141|O5|Outcome|Confident|
931924|NCT00999141|O4|Outcome|Somewhat Confident|
931925|NCT00999141|O3|Outcome|Neutral|
931926|NCT00999141|O2|Outcome|Not Very Confident|
931927|NCT00999141|O1|Outcome|Not Confident|
931928|NCT00999141|O5|Outcome|Very Satisfied|
931929|NCT00999141|O4|Outcome|Moderately Satisfied|
931930|NCT00999141|O3|Outcome|Somewhat Satisfied|
931931|NCT00999141|O2|Outcome|A Little Satisfied|
931932|NCT00999141|O1|Outcome|Not at All Satisfied|
931933|NCT00999141|O5|Outcome|Very Satisfied|
931934|NCT00999141|O4|Outcome|Moderately Satisfied|
931935|NCT00999141|O3|Outcome|Somewhat Satisfied|
931936|NCT00999141|O2|Outcome|A Little Satisfied|
931937|NCT00999141|O1|Outcome|Not at All Satisfied|
931938|NCT00999141|O5|Outcome|Very Satisfied|
931939|NCT00999141|O4|Outcome|Moderately Satisfied|
931940|NCT00999141|O3|Outcome|Somewhat Satisfied|
931941|NCT00999141|O2|Outcome|A Little Satisfied|
931942|NCT00999141|O1|Outcome|Not at All Satisfied|
931943|NCT00999141|O5|Outcome|Strongly Prefer SoC Side|
931944|NCT00999141|O4|Outcome|Somewhat Prefer SoC Side|
931945|NCT00999141|O3|Outcome|No Preference|
931946|NCT00999141|O2|Outcome|Somewhat Prefer FS VH S/D 4 S-apr Side|
931947|NCT00999141|O1|Outcome|Strongly Prefer FS VH S/D 4 S-apr Side|
931948|NCT00999141|O1|Outcome|Facelift Participants|
931949|NCT00999141|O8|Outcome|SoC Side - Day 14|
931950|NCT00999141|O7|Outcome|FS VH S/D 4 S-apr Side - Day 14|
931951|NCT00999141|O6|Outcome|SoC Side - Day 7|
931952|NCT00999141|O5|Outcome|FS VH S/D 4 S-apr Side - Day 7|
931953|NCT00999141|O4|Outcome|SoC Side - Day 3|
931954|NCT00999141|O3|Outcome|FS VH S/D 4 S-apr Side - Day 3|
931955|NCT00999141|O2|Outcome|SoC Side - Day 1|
931956|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Day 1|
931957|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
931958|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
931959|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
931960|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
931961|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
931962|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
931963|NCT00999141|O2|Outcome|Proportion of Participants Preferring SoC Side|
931964|NCT00999141|O1|Outcome|Proportion of Participants Preferring FS VH S/D 4 S-apr Side|
931965|NCT00999141|O3|Outcome|Participants With No Preference|
931966|NCT00999141|O2|Outcome|Participants Preferring SoC|
931967|NCT00999141|O1|Outcome|Participants Preferring FS VH S/D 4 S-apr|
931968|NCT00999141|O2|Outcome|Standard of Care (SoC)|
931969|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|
931970|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
931971|NCT00999141|O2|Outcome|Participants With Less Edema on SoC Side|
931972|NCT00999141|O1|Outcome|Participants With Less Edema on FS VH S/D 4 S-apr Side|
931973|NCT00999141|O3|Outcome|Participants With No Difference in Edema|
931982|NCT00999141|O4|Outcome|Participants With No Hematoma/Seroma on Either Side|
931983|NCT00999141|O3|Outcome|Participants With Hematoma/Seroma on Both Sides|
931984|NCT00999141|O2|Outcome|Participants With Hematoma/Seroma on SoC Side|
931985|NCT00999141|O1|Outcome|Participants With Hematoma/Seroma on FS VH S/D 4 S-apr Side|
931986|NCT00999141|O2|Outcome|Standard of Care (SoC)|Participants With Hematoma/Seroma on SoC Side
931987|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr|Participants With Hematoma/Seroma on FS VH S/D 4 s-apr Side
931988|NCT00999141|O4|Outcome|Standard of Care (SoC) Side - Seroma|
931989|NCT00999141|O3|Outcome|Standard of Care (SoC) Side - Hematoma|
931990|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr Side - Seroma|
931991|NCT00999141|O1|Outcome|FS VH S/D 4 S-apr Side - Hematoma|
931992|NCT00999141|O2|Outcome|FS VH S/D 4 S-apr|
931993|NCT00999141|O1|Outcome|Standard of Care (SoC)|
931994|NCT00999141|E3|Reported Event|Non-localized AEs|AE affected a site other than either side of the face (ie, non-localized AE)
931995|NCT00999141|E2|Reported Event|Localized to FS VH S/D 4 S-apr Side of Face|AE was localized to the side of the face which was treated with FS VH S/D 4 s-apr
931996|NCT00999141|E1|Reported Event|Localized to SoC Side of Face|AE was localized to the side of the face which was treated with standard of care (SoC).
932001|NCT00999037|P1|Participant Flow|Renvela|Sevelamer Carbonate (Renvela) 800 mg tablets: 1 tablet TID with meals for 12 weeks
932002|NCT00999037|O2|Outcome|Placebo|Placebo: 1 inert tablet tid x 12 weeks
932003|NCT00999037|O1|Outcome|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
932004|NCT00999037|O2|Outcome|Placebo|Placebo: 1 inert tablet tid x 12 weeks
932005|NCT00999037|O1|Outcome|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
932006|NCT00999037|O2|Outcome|Placebo|Placebo (1 inert tablet) PO TID with meals x 12 weeks
932007|NCT00999037|O1|Outcome|Renvela|Sevelamer Carbonate (800 mg tablet) PO TID with meals x 12 weeks
932008|NCT00999037|E2|Reported Event|Placebo|Placebo: 1 inert tablet tid x 12 weeks
932009|NCT00999037|E1|Reported Event|Renvela|"Daily renvela with meals for 12 weeks~Sevelamer Carbonate: Daily renvela (800 mg tid with meals) x 12 weeks"
932010|NCT00998985|B15|Baseline|Total|Total of all reporting groups
932011|NCT00998985|B14|Baseline|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932012|NCT00998985|B13|Baseline|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932013|NCT00998985|B12|Baseline|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932014|NCT00998985|B11|Baseline|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932015|NCT00998985|B10|Baseline|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932016|NCT00998985|B9|Baseline|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932017|NCT00998985|B8|Baseline|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932018|NCT00998985|B7|Baseline|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932019|NCT00998985|B6|Baseline|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932020|NCT00998985|B5|Baseline|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932021|NCT00998985|B4|Baseline|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932022|NCT00998985|B3|Baseline|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932023|NCT00998985|B2|Baseline|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932024|NCT00998985|B1|Baseline|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932025|NCT00998985|P14|Participant Flow|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932026|NCT00998985|P13|Participant Flow|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932027|NCT00998985|P12|Participant Flow|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932028|NCT00998985|P11|Participant Flow|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932029|NCT00998985|P10|Participant Flow|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932030|NCT00998985|P9|Participant Flow|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932031|NCT00998985|P8|Participant Flow|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932032|NCT00998985|P7|Participant Flow|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932033|NCT00998985|P6|Participant Flow|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932034|NCT00998985|P5|Participant Flow|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932035|NCT00998985|P4|Participant Flow|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932036|NCT00998985|P3|Participant Flow|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932037|NCT00998985|P2|Participant Flow|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932038|NCT00998985|P1|Participant Flow|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932039|NCT00998985|O14|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932040|NCT00998985|O13|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932041|NCT00998985|O12|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932042|NCT00998985|O11|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932043|NCT00998985|O10|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932044|NCT00998985|O9|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932045|NCT00998985|O8|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932046|NCT00998985|O7|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932047|NCT00998985|O6|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932048|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932049|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932050|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932051|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932052|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932053|NCT00998985|O14|Outcome|100 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932054|NCT00998985|O13|Outcome|200 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932055|NCT00998985|O12|Outcome|800 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932056|NCT00998985|O11|Outcome|600 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932057|NCT00998985|O10|Outcome|400 mg Grazoprevir - GT3|GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932058|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|Pooled GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932059|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932060|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932061|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932062|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932063|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932064|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932065|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932066|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932067|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932068|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932069|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932070|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932071|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932072|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932073|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932074|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932075|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932076|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932077|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932078|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932079|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932080|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932081|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932082|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932083|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932084|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932085|NCT00998985|O9|Outcome|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932086|NCT00998985|O8|Outcome|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932087|NCT00998985|O7|Outcome|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932088|NCT00998985|O6|Outcome|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932089|NCT00998985|O5|Outcome|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932090|NCT00998985|O4|Outcome|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932091|NCT00998985|O3|Outcome|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932092|NCT00998985|O2|Outcome|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932093|NCT00998985|O1|Outcome|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932094|NCT00998985|E9|Reported Event|Placebo for Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: Placebo for Grazoprevir orally, once daily for 7 consecutive days
932095|NCT00998985|E8|Reported Event|10 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 10 mg Grazoprevir orally, once daily for 7 consecutive days
932096|NCT00998985|E7|Reported Event|30 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 30 mg Grazoprevir orally, once daily for 7 consecutive days
932097|NCT00998985|E6|Reported Event|50 mg Grazoprevir - GT1|GT1 HCV-infected Participants: 50 mg Grazoprevir orally, once daily for 7 consecutive days
932098|NCT00998985|E5|Reported Event|100 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 100 mg Grazoprevir orally, once daily for 7 consecutive days
932099|NCT00998985|E4|Reported Event|200 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 200 mg Grazoprevir orally, once daily for 7 consecutive days
932100|NCT00998985|E3|Reported Event|800 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 800 mg Grazoprevir orally, once daily for 7 consecutive days
932101|NCT00998985|E2|Reported Event|600 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 600 mg Grazoprevir orally, once daily for 7 consecutive days
932102|NCT00998985|E1|Reported Event|400 mg Grazoprevir - GT1 and GT3|GT1 and GT3 HCV-infected Participants: 400 mg Grazoprevir orally, once daily for 7 consecutive days
932103|NCT00998881|B3|Baseline|Total|Total of all reporting groups
932104|NCT00998881|B2|Baseline|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
932105|NCT00998881|B1|Baseline|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
932106|NCT00998881|P2|Participant Flow|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
932107|NCT00998881|P1|Participant Flow|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
932108|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
932109|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
932110|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
932111|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
932112|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
932113|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
932114|NCT00998881|O2|Outcome|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
932115|NCT00998881|O1|Outcome|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
932116|NCT00998881|E2|Reported Event|Teneligliptin 20 mg|Teneligliptin 20 mg, orally, once daily
932117|NCT00998881|E1|Reported Event|Placebo|Teneligliptin placebo-matching tablets, orally, once daily
932118|NCT00998868|B1|Baseline|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
932119|NCT00998868|P1|Participant Flow|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
932120|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
932121|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
932122|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
932123|NCT00998868|O1|Outcome|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
932124|NCT00998868|E1|Reported Event|Hemiplegia|patients with hemiplegia, without other musculoskeletal disorders of the shoulder
932125|NCT00998764|B3|Baseline|Total|Total of all reporting groups
932126|NCT00998764|B2|Baseline|Bapineuzumab/Bapineuzumab|Participants received Bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932127|NCT00998764|B1|Baseline|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study Bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932128|NCT00998764|P2|Participant Flow|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932129|NCT00998764|P1|Participant Flow|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by intravenous (IV) infusion approximately every 13 weeks up to week 195.
932451|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932130|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932131|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932132|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932133|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932134|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932135|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932136|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932137|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932138|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932139|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932140|NCT00998764|O2|Outcome|Bapinezumab/Bapinezumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932141|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932142|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932143|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932144|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932145|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932146|NCT00998764|O2|Outcome|Bapineuzumab/Bapineuzumab|Participants received bapineuzumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932147|NCT00998764|O1|Outcome|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932148|NCT00998764|E2|Reported Event|Bapineuzumab/Bapineuzumab|Participants received bapinezumab in both the base and extension studies. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932149|NCT00998764|E1|Reported Event|Placebo/Bapineuzumab|Participants received placebo in the base study and bapineuzumab in this extension study. In this extension study bapineuzumab 0.5 mg/kg was administered by IV infusion approximately every 13 weeks up to week 195.
932150|NCT00998738|B1|Baseline|Overall|
932151|NCT00998738|P1|Participant Flow|Overall|
932152|NCT00998738|O1|Outcome|Overall|
932153|NCT00998738|O1|Outcome|Overall|
932154|NCT00998738|O1|Outcome|Overall|
932155|NCT00998738|O1|Outcome|Overall|
932156|NCT00998738|O1|Outcome|Overall|
932157|NCT00998738|O1|Outcome|Overall|
932158|NCT00998738|O1|Outcome|Overall|
932159|NCT00998738|O1|Outcome|Overall|
932160|NCT00998738|O1|Outcome|Overall|
932161|NCT00998738|E1|Reported Event|Overall|
932162|NCT00998660|B4|Baseline|Total|Total of all reporting groups
932163|NCT00998660|B3|Baseline|Parkinsons Disease Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Parkinson's Disease.
932164|NCT00998660|B2|Baseline|Essential Tremor Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat Essential Tremor.
932165|NCT00998660|B1|Baseline|Dystonia Patients Implanted With the Activa RC|Patients who were implanted with the Activa RC neurostimulator to treat dystonia.
932166|NCT00998660|P1|Participant Flow|Patients Receiving an Activa RC Implant|Activa RC: Patients receiving Activa RC as their first implantable neurostimulator or as a replacement implantable neurostimulator for deep brain stimulation
932167|NCT00998660|O1|Outcome|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
932168|NCT00998660|E1|Reported Event|Patients Implanted With the Activa RC|All enrolled patients implanted with the Activa RC neurostimulator.
932169|NCT00998582|B3|Baseline|Total|Total of all reporting groups
932170|NCT00998582|B2|Baseline|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
932171|NCT00998582|B1|Baseline|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
932172|NCT00998582|P2|Participant Flow|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
932173|NCT00998582|P1|Participant Flow|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
932174|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
932175|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
932176|NCT00998582|O2|Outcome|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
932177|NCT00998582|O1|Outcome|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
932415|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932178|NCT00998582|E2|Reported Event|Tenofovir|Participants randomized to this arm will switch from taking abacavir (co-formulated with lamivudine as Epzicom) and start taking tenofovir (co-formulated with emtricitabine as Truvada), and continue their other HIV medications
932179|NCT00998582|E1|Reported Event|Abacavir|Participants randomized to this arm will continue abacavir and their other HIV medications with no changes
932180|NCT00998517|B4|Baseline|Total|Total of all reporting groups
932181|NCT00998517|B3|Baseline|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932182|NCT00998517|B2|Baseline|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932183|NCT00998517|B1|Baseline|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932184|NCT00998517|P3|Participant Flow|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932185|NCT00998517|P2|Participant Flow|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932186|NCT00998517|P1|Participant Flow|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932187|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932188|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932189|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932190|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932191|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932192|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932193|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932194|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932195|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932196|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932197|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932198|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932199|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932200|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932201|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932202|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932203|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932204|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932205|NCT00998517|O3|Outcome|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932206|NCT00998517|O2|Outcome|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932207|NCT00998517|O1|Outcome|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932208|NCT00998517|E3|Reported Event|Supplementary Plumpy®|Supplementary Plumpy® : 75 kcal/kg/day
932209|NCT00998517|E2|Reported Event|Soy/Peanut Fortified Spread|Soy/peanut fortified spread : 75kcal/kg/day
932210|NCT00998517|E1|Reported Event|Milk Fortified Corn/Soy Blend|Milk fortified corn/soy blend : 75 kcal/kg/day
932211|NCT00998426|B1|Baseline|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. All participants will undergo two finger stick tests, one with a glucose-specific monitoring device(GS-POC) and one with a glucose non-specific monitoring device(GNS-POC) and a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose ). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
932235|NCT00998335|P1|Participant Flow|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932682|NCT00997321|O1|Outcome|Propofol|median depth of sedation by the observers assesment of alertness scale in the propofol group
932212|NCT00998426|P1|Participant Flow|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
932213|NCT00998426|O1|Outcome|All Study Participants|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device (GS-POC)and one with a glucose non-specific (GNS-POC) monitoring device; a venous blood glucose level. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
932277|NCT00998309|O1|Outcome|Azithromycin Without Renal Dysfunction|Participants without Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
933694|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
932214|NCT00998426|E2|Reported Event|Chronic Phase|"Study procedures will occur one time at least three (3) months post liver transplant. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~glucose monitoring before and after HepaGam B administration: Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.~HepaGam B (Hepatitis B Immune Globulin (HBIG)): Subjects will be gi"
932215|NCT00998426|E1|Reported Event|Acute Phase|"Study procedures will occur one time between post-op day 1 and post-op day 7. These will include blood glucose monitoring prior to and after (various time points for 2 hours after) infusion with HBIG.~Prior to receiving the dose of HepaGam B HBIG, blood glucose will be monitored in 3 manners. These will include two finger stick tests, one with a glucose-specific monitoring device and one with a glucose non-specific monitoring device; a venous blood glucose level; and a urine glucose test. Patients will receive the HBIG infusion and then immediately after the dose will have the same blood glucose tests repeated (finger sticks, venous glucose and urine glucose). Then at 60 minutes and 120 minutes after the dose is given, patients will again have finger stick tests with the glucose specific and glucose non-specific monitoring devices.Subjects will be given 20,000 IU HepaGam B after the initial blood glucose monitoring, and prior to the post-infusion blood glucose monitoring"
932216|NCT00998374|B3|Baseline|Total|Total of all reporting groups
932217|NCT00998374|B2|Baseline|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass
932218|NCT00998374|B1|Baseline|Pyloric-sparing|Pyloric sparing: Sleeve Gastrectomy and Duodenal Switch
932219|NCT00998374|P2|Participant Flow|Non-pyloric Sparing|Non-pyloric sparing: Roux-en-Y Gastric Bypass (RYGB)
932220|NCT00998374|P1|Participant Flow|Pyloric-sparing|Pyloric: Sleeve Gastrectomy (SG) & Duodenal Switch (DS)
932221|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
932222|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
932223|NCT00998374|O2|Outcome|Non-pyloric|Non-pyloric: RYGB
932224|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
932225|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric: RYGB
932226|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
932227|NCT00998374|O2|Outcome|Non-pyloric Sparing|Non-pyloric sparing: RYGB
932228|NCT00998374|O1|Outcome|Pyloric-sparing|Pyloric: SG & DS
932229|NCT00998374|E2|Reported Event|Non-pyloric Sparing|Non-pyloric: RYGB
932230|NCT00998374|E1|Reported Event|Pyloric-sparing|Pyloric: SG & DS
932231|NCT00998335|B3|Baseline|Total|Total of all reporting groups
932232|NCT00998335|B2|Baseline|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932233|NCT00998335|B1|Baseline|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932234|NCT00998335|P2|Participant Flow|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932236|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations, insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart (insulin detemir plus aspart) will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated. This group will receive Insulin detemir and pre-meal insulin aspart.~Insulin detemir and pre-meal insulin aspart.: This group will receive Insulin detemir plus aspart. The group will start with Insulin detemir at bedtime. Then in three months they will Insulin aspart before breakfast, lunch and dinner."
932237|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl. This group will receive Long-acting bedtime insulin detemir (Levemir).~Long-acting bedtime insulin detemir (Levemir): This group will receive Insulin detemir. Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932238|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
932416|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932239|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932240|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932241|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
932242|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932243|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
932244|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932245|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
932246|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
932247|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932248|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
932266|NCT00998309|O2|Outcome|Azithromycin With Non-drug Therapy|Participants with non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932455|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932249|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932250|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
932251|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932252|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir was given at bedtime. Insulin aspart before breakfast, lunch and dinner."
932278|NCT00998309|O2|Outcome|Azithromycin With Hepatic Dysfunction|Participants with Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932615|NCT00997438|B4|Baseline|Total|Total of all reporting groups
932253|NCT00998335|O1|Outcome|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months. After patients were treated for 3 months with bedtime insulin detemir they were randomized to either continue with bedtime insulin detemir or add premeal rapid-acting insulin novolog.~Long-acting bedtime insulin detemir (Levemir) was given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932254|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932255|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
932256|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932257|NCT00998335|O1|Outcome|Insulin Detemir Only (3 and 6 Months)|All patients with uncontrolled T2DM are treated with insulin detemir for 6 months and after 3 months randomized to either arm. Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl.
932258|NCT00998335|O2|Outcome|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932259|NCT00998335|O1|Outcome|Insulin Detemir x 3 Months (All Pts Had Liver MRS)|Liver fat by MRS measured after 3 months of insulin.
932260|NCT00998335|E2|Reported Event|Insulin Detemir Plus Aspart|"After baseline evaluations (admission #1) insulin detemir will be given at bedtime and titrated to achieve a fasting plasma glucose between 80-100 mg/dl. After 3 months patients will be admitted to assess the metabolic effects of intervention. After this, insulin aspart will be added before breakfast, lunch and dinner titrated to normalize the postprandial plasma glucose. After another 3 months patients are readmitted and all study procedures repeated as during admissions #1 and #2.~Insulin detemir and pre-meal insulin aspart. : Insulin detemir at bedtime. Insulin aspart before breakfast, lunch and dinner."
932261|NCT00998335|E1|Reported Event|Insulin Detemir Only|"Patients with uncontrolled T2DM are treated with insulin detemir for 6 months~Long-acting bedtime insulin detemir (Levemir) : Insulin detemir is given at bedtime aiming at a fasting plasma glucose between 80-100 mg/dl."
932262|NCT00998309|B1|Baseline|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932263|NCT00998309|P1|Participant Flow|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932264|NCT00998309|O2|Outcome|Azithromycin With Pregnancy in Female|Female participants with Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932265|NCT00998309|O1|Outcome|Azithromycin Without Pregnancy in Female|Female participants without Pregnancy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
933667|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
932267|NCT00998309|O1|Outcome|Azithromycin Without Non-drug Therapy|Participants without non-drug therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932268|NCT00998309|O2|Outcome|Azithromycin- With Comcomittant Drugs|Participants with comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932269|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without comcomittant drugs who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932270|NCT00998309|O2|Outcome|Azithromycin-with PATH|Participants with previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932271|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without previous antibioutic treatment history (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932272|NCT00998309|O2|Outcome|Azithromycin-with Complications|Participants with complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932273|NCT00998309|O1|Outcome|Azithromycin -Without Complications|Participants without complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932274|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932275|NCT00998309|O1|Outcome|Azithromycin -Without Past Medical History|Participants without Past Medical History who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932276|NCT00998309|O2|Outcome|Azithromycin- With Renal Dysfunction|Participants with Renal Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932279|NCT00998309|O1|Outcome|Azithromycin Without Hepatic Dysfunction|Participants without Hepatic Dysfunction who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932280|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932281|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932282|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932283|NCT00998309|O3|Outcome|Azithromycin-Dental, or Oral Surgery Infection|Participants with Dental, or Oral Surgery Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932284|NCT00998309|O2|Outcome|Azithromycin - Sexual Transmitted Infection|"Participants with Skin and Soft Tissue Infection, Sexual Transmitted Infection, or Dental, or Oral Surgery Infectionwho took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert."
932285|NCT00998309|O1|Outcome|Azithromycin - Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932286|NCT00998309|O2|Outcome|Azithromycin >=65 Years|Participants >=65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932287|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932288|NCT00998309|O2|Outcome|Azithromycin Female|Female participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932289|NCT00998309|O1|Outcome|Azithromycin Male|Male participants who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932290|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932291|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932292|NCT00998309|O2|Outcome|Azithromycin-with Non-Drug Therapy|Participants with Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932293|NCT00998309|O1|Outcome|Azithromycin -With Non-Drug Therapy|Participants without Non-Drug Therapy who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932294|NCT00998309|O2|Outcome|Azithromycin With Comcomittant Drugs|Participants with Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932295|NCT00998309|O1|Outcome|Azithromycin Without Comcomittant Drugs|Participants without Comcomittant Drugs (CD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932296|NCT00998309|O2|Outcome|Azithromycin With PATH|Participants with Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932297|NCT00998309|O1|Outcome|Azithromycin Without PATH|Participants without Previous Antibiotic Treatment History (PATH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932298|NCT00998309|O2|Outcome|Azithromycin With Complications|Participants with Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932299|NCT00998309|O1|Outcome|Azithromycin Without Complications|Participants without Complications who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932300|NCT00998309|O2|Outcome|Azithromycin- With Past Medical History|Participants with Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932301|NCT00998309|O1|Outcome|Azithromycin-without Past Medical History|Participants without Past Medical History (PMH) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932302|NCT00998309|O2|Outcome|Azithromycin-with Renal Dysfunction|Participants with Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932303|NCT00998309|O1|Outcome|Azithromycin-without Renal Dysfunction|Participants without Renal Dysfunction (RD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932304|NCT00998309|O2|Outcome|Azithromycin-with Hepatic Dysfunction|Participants with Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932305|NCT00998309|O1|Outcome|Azithromycin -Without Hepatic Dysfunction|Participants without Hepatic Dysfunction (HD) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932306|NCT00998309|O3|Outcome|Azithromycin-severe Infection|Participants with severe infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932307|NCT00998309|O2|Outcome|Azithromycin-moderate Infection|"Participants with moderate infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.~, moderate infection, or severe in"
932308|NCT00998309|O1|Outcome|Azithromycin-mild Infection|Participants with mild infection who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932309|NCT00998309|O3|Outcome|Aazithromycin-Dental and Oral Surgery Infection|Participants with Dental and Oral Surgery Infection (DOSI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932310|NCT00998309|O2|Outcome|Azithromycin-Sexual Transmitted Infection|Participants with Sexual Transmitted Infection (STI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932411|NCT00998049|B1|Baseline|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932311|NCT00998309|O1|Outcome|Azithromycin -Skin and Soft Tissue Infection|Participants with Skin and Soft Tissue Infection (SSTI) who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932312|NCT00998309|O2|Outcome|Azithromycin->=65 Years|Participants>=65 years who took Azithromycin SR as a single dose of 2 g (potency, as azithromycin) with an empty stomach according to Japanese Package Insert.
932313|NCT00998309|O1|Outcome|Azithromycin <65 Years|Participants with <65 years who took azithromycin SR as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932314|NCT00998309|O2|Outcome|Azithromycin-Female|Female Participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932315|NCT00998309|O1|Outcome|Azithromycin -Male|Male participants who took azithromycin SR orally as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932316|NCT00998309|O1|Outcome|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932317|NCT00998309|E1|Reported Event|Azithromycin SR|Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.
932318|NCT00998296|B12|Baseline|Total|Total of all reporting groups
932319|NCT00998296|B11|Baseline|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932320|NCT00998296|B10|Baseline|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932321|NCT00998296|B9|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932322|NCT00998296|B8|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932323|NCT00998296|B7|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932324|NCT00998296|B6|Baseline|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932325|NCT00998296|B5|Baseline|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932326|NCT00998296|B4|Baseline|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932327|NCT00998296|B3|Baseline|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932452|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
942972|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
932328|NCT00998296|B2|Baseline|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932329|NCT00998296|B1|Baseline|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932330|NCT00998296|P11|Participant Flow|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932331|NCT00998296|P10|Participant Flow|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932332|NCT00998296|P9|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932333|NCT00998296|P8|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932412|NCT00998049|P1|Participant Flow|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932334|NCT00998296|P7|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932335|NCT00998296|P6|Participant Flow|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932336|NCT00998296|P5|Participant Flow|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932337|NCT00998296|P4|Participant Flow|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932338|NCT00998296|P3|Participant Flow|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932339|NCT00998296|P2|Participant Flow|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932340|NCT00998296|P1|Participant Flow|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932341|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932342|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932343|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932344|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932345|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932453|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932346|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932347|NCT00998296|O2|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932348|NCT00998296|O1|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932349|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932350|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932351|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg- Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932413|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932352|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg- Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932353|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932354|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932355|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932356|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932357|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932358|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932359|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932360|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932361|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932362|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932363|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932384|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932454|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932364|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932365|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932366|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932367|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932368|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932369|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932370|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932371|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932372|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932373|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932374|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932375|NCT00998296|O11|Outcome|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg bid plus film-coated tablet of Afatinib 30 mg qd).~This is a part of the expansion phase which follows on the dose-escalation phase."
932376|NCT00998296|O10|Outcome|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932377|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932378|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932379|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932380|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932381|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932382|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932383|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932385|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932386|NCT00998296|O9|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932387|NCT00998296|O8|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932388|NCT00998296|O7|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week.~This is a part of the dose-escalation phase."
932389|NCT00998296|O6|Outcome|Nintedanib 200 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932390|NCT00998296|O5|Outcome|Nintedanib 200 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932391|NCT00998296|O4|Outcome|Nintedanib 200 mg +Afatinib 20 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 20 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932414|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
933695|NCT00996632|O2|Outcome|Conventional|Patients were operated by a conventional diatherm knife
932392|NCT00998296|O3|Outcome|Nintedanib 200 mg +Afatinib 10 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 10 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932393|NCT00998296|O2|Outcome|Nintedanib 150 mg +Afatinib 40 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 40 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932394|NCT00998296|O1|Outcome|Nintedanib 150 mg +Afatinib 30 mg - Continuously|"Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, film-coated tablet of Afatinib 30 mg was given continuously once daily (q.d.).~This is a part of the dose-escalation phase."
932395|NCT00998296|E11|Reported Event|Pancreatic Adenocarcinoma|"Patients with Pancreatic adenocarcinoma were to be treated with the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d) plus film-coated tablet of Afatinib 30 mg (q.d)). This is a part of the expansion phase which follows on the dose-escalation phase."
932396|NCT00998296|E10|Reported Event|NSCLC|"Patients with non-small cell lung cancer (NSCLC) receiving the study drug combination at the maximum tolerated dose (MTD) level determined for continuous afatinib and nintedanib dosing during the dose-escalation phase (oral administration of soft-gelatine capsule of Nintedanib 150 mg (b.i.d.) plus film-coated tablet of Afatinib 30 mg (q.d.)).~This is a part of the expansion phase which follows on the dose-escalation phase."
932397|NCT00998296|E9|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
932398|NCT00998296|E8|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given intermittently once daily (q.d.) every other week
932399|NCT00998296|E7|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Intermittently|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given intermittently once daily (q.d.) every other week
932400|NCT00998296|E6|Reported Event|Nintedanib 200 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
932401|NCT00998296|E5|Reported Event|Nintedanib 200 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
932402|NCT00998296|E4|Reported Event|Nintedanib 200 mg +Afatinib 20 mg - Continuosly|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 20 mg was given continuously once daily (q.d.)
932403|NCT00998296|E3|Reported Event|Nintedanib 200 mg +Afatinib 10 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 200 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 10 mg was given continuously once daily (q.d.)
932404|NCT00998296|E2|Reported Event|Nintedanib 150 mg +Afatinib 40 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 40 mg was given continuously once daily (q.d.)
932449|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932450|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932405|NCT00998296|E1|Reported Event|Nintedanib 150 mg +Afatinib 30 mg - Continuously|Patients receiving oral administration of soft-gelatine capsule of Nintedanib 150 mg continuously twice daily (b.i.d.); concomitantly, filmcoated tablet of Afatinib 30 mg was given continuously once daily (q.d.)
932406|NCT00998205|B1|Baseline|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
932407|NCT00998205|P1|Participant Flow|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
932408|NCT00998205|O1|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
932409|NCT00998205|O1|Outcome|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
932410|NCT00998205|E1|Reported Event|Dobutamine Stress Echo (DSE)|Dobutamine intravenous infusion would be undertaken starting at 10 micrograms/kg per minute in three minute intervals increased to 20, 30, 40 or 50 micrograms/kg per minute or to a peak heart rate response of at least 85% age predicted maximum heart rate. If at the end of the Dobutamine protocol, there is inadequate heart rate response, intravenous atropine boluses of 0.5 milligrams (maximum 1.0 mg) would be used as needed to achieve a heart rate of at least 85% of age predicted maximum heart rate.
932417|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932418|NCT00998049|O1|Outcome|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932419|NCT00998049|E1|Reported Event|Plerixafor|"Plerixafor 160mg/kg/dose by IV on days 5-8~Filgrastim (G-CSF) 10 mg/kg/dose subcutaneously on days 1-8."
932420|NCT00998023|B3|Baseline|Total|Total of all reporting groups
932421|NCT00998023|B2|Baseline|AngioSeal VCD|AngioSeal Vascular Closure Device
932422|NCT00998023|B1|Baseline|Mynx VCD|Mynx Vascular Closure Device
932423|NCT00998023|P2|Participant Flow|AngioSeal VCD|AngioSeal Vascular Closure Device
932424|NCT00998023|P1|Participant Flow|Mynx VCD|Mynx Vascular Closure Device
932425|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
932426|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
932427|NCT00998023|O2|Outcome|AngioSeal VCD|AngioSeal Vascular Closure Device
932428|NCT00998023|O1|Outcome|Mynx VCD|Mynx Vascular Closure Device
932429|NCT00998023|E2|Reported Event|AngioSeal VCD|AngioSeal Vascular Closure Device
932430|NCT00998023|E1|Reported Event|Mynx VCD|Mynx Vascular Closure Device
932431|NCT00997984|B4|Baseline|Total|Total of all reporting groups
932432|NCT00997984|B3|Baseline|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932433|NCT00997984|B2|Baseline|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932434|NCT00997984|B1|Baseline|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932435|NCT00997984|P3|Participant Flow|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932436|NCT00997984|P2|Participant Flow|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932437|NCT00997984|P1|Participant Flow|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932438|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932439|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932440|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932441|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932442|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932443|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932444|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932445|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932446|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932447|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932448|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
945281|NCT00964860|B3|Baseline|Total|Total of all reporting groups
932456|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932457|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932458|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932459|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932460|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932461|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932462|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932463|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932464|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932465|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932466|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932467|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
933696|NCT00996632|O1|Outcome|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
932468|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932469|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932470|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932471|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932472|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932473|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932474|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932475|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932476|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932477|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932478|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932479|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932480|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932481|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932482|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932483|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932484|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932485|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932486|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932487|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932488|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932489|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932490|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932491|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932492|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932493|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932494|NCT00997984|O4|Outcome|All-Active|The combined results of the SPD503 AM and PM groups
932495|NCT00997984|O3|Outcome|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932496|NCT00997984|O2|Outcome|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932497|NCT00997984|O1|Outcome|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
932498|NCT00997984|E4|Reported Event|All Active|The combined results of the SPD503 AM and PM groups
932499|NCT00997984|E3|Reported Event|SPD503 PM|Placebo dosed once daily in the AM (upon awakening) and SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the PM (7:00 PM)
932500|NCT00997984|E2|Reported Event|SPD503 AM|SPD503 dosed once daily at either 1, 2, 3 or 4 mg in the morning (upon awakening) and placebo dosed once daily in the PM (7:00 PM)
932501|NCT00997984|E1|Reported Event|Placebo|Dosed once daily in the morning (upon awakening) and once daily in the evening (7:00 PM)
934163|NCT00995904|B1|Baseline|All Patients|All patients that were enrolled in the study.
932502|NCT00997932|B1|Baseline|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
932503|NCT00997932|P1|Participant Flow|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
932504|NCT00997932|O1|Outcome|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
932505|NCT00997932|E2|Reported Event|No IUD Insertion|Women in this group underwent baseline data collection, stated they would like to enroll and receive an IUD between 10 minutes and 48 hours postpartum. These women were not eligible to receive the IUD due to delivery elsewhere, medical complications in peri-partum period.
932506|NCT00997932|E1|Reported Event|Immediate Insertion|"Women in the immediate insertion arm received a Mirena intrauterine contraceptive system within 10 minutes and up to 48 hours of delivery.~Mirena Intrauterine Contraceptive System: Postpartum placement of the IUD within 10 minutes - 48 hours"
932507|NCT00997672|B3|Baseline|Total|Total of all reporting groups
932508|NCT00997672|B2|Baseline|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
932509|NCT00997672|B1|Baseline|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
932510|NCT00997672|P2|Participant Flow|Placebo|Placebo
932511|NCT00997672|P1|Participant Flow|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
932512|NCT00997672|O2|Outcome|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
932513|NCT00997672|O1|Outcome|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
932514|NCT00997672|E2|Reported Event|Placebo|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
932515|NCT00997672|E1|Reported Event|Lithium CARBONATE 150 or 300 mg|Lithium Carbonate : Lithium Carbonate will be dosed based on lithiemy, which will be in the range 0.9-1.2 mEq/L. Maximum allowed dose will be 1500mg/day.
932516|NCT00997594|B3|Baseline|Total|Total of all reporting groups
932517|NCT00997594|B2|Baseline|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
932518|NCT00997594|B1|Baseline|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
932519|NCT00997594|P2|Participant Flow|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
932520|NCT00997594|P1|Participant Flow|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
932521|NCT00997594|O2|Outcome|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
932522|NCT00997594|O1|Outcome|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
932523|NCT00997594|E2|Reported Event|Abdominal Radiofrequency Ablation Other Than Adrenal Gland|Patients who received radiofrequency (RF) ablation other than adrenal gland such as liver and kidney.
932524|NCT00997594|E1|Reported Event|Adrenal Radiofrequency Ablation|Patients who received adrenal radiofrequency (RF) ablation.
932525|NCT00997555|B3|Baseline|Total|Total of all reporting groups
932526|NCT00997555|B2|Baseline|Control Group|Standard treatment without scheduled bronchoscopy.
932527|NCT00997555|B1|Baseline|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932528|NCT00997555|P2|Participant Flow|Control Group|Standard treatment without scheduled bronchoscopy.
932529|NCT00997555|P1|Participant Flow|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932530|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
932531|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932532|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
932533|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932534|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
932535|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932536|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
932537|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932538|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
932539|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932540|NCT00997555|O2|Outcome|Control Group|Standard treatment without scheduled bronchoscopy.
932541|NCT00997555|O1|Outcome|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932542|NCT00997555|E2|Reported Event|Control Group|Standard treatment without scheduled bronchoscopy.
932543|NCT00997555|E1|Reported Event|Bronchoscopy Intervention Group|Group undergoing scheduled bronchoscopy. Patients had bronchoscopy and BAL performed within 12 hours of arrival and every 3 days sequentially. A positive BAL (> 100K CFU/ml) were treated with antibiotics according to sensitivites.
932544|NCT00997516|B3|Baseline|Total|Total of all reporting groups
932545|NCT00997516|B2|Baseline|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932546|NCT00997516|B1|Baseline|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932547|NCT00997516|P2|Participant Flow|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932548|NCT00997516|P1|Participant Flow|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932549|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932550|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932551|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932552|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932553|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932554|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932555|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932556|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932557|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932558|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932559|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932560|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932561|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932562|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932563|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932564|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932565|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932566|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932567|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932568|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932569|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932570|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932571|NCT00997516|O2|Outcome|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932572|NCT00997516|O1|Outcome|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932573|NCT00997516|E2|Reported Event|Conventional Laparoscopic Appendectomy|Conventional laparoscopic appendectomy: conventional laparoscopic removal of the appendix
932574|NCT00997516|E1|Reported Event|SILS Appendectomy|SILS appendectomy: Use of SILS Port to perform laparoscopic appendectomy
932575|NCT00997503|B1|Baseline|TAXUS Liberté Post-Approval Study Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932576|NCT00997503|P1|Participant Flow|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932577|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932578|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932579|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932647|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932580|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932581|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932582|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932583|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932584|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932585|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932586|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932587|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932588|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932589|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932590|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932591|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932592|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932593|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932594|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932595|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932596|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932597|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932598|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932599|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932600|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932601|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932602|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932603|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932604|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932605|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
934414|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
932606|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932607|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932608|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932609|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932610|NCT00997503|O1|Outcome|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932611|NCT00997503|O1|Outcome|Medically Treated Diabetic Population|Patients enrolled in the TAXUS Libertē Post-Approval Study with medically treated diabetes.
932612|NCT00997503|O1|Outcome|TAXUS Libertē: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932613|NCT00997503|O1|Outcome|TAXUS Libertē Post-Approval Study Enrolled Population|There were a total of 4,199 patients in the TAXUS Libertē Post-Approval Study that received at least one TAXUS Liberte stent.
932614|NCT00997503|E1|Reported Event|TAXUS Liberté: Overall Enrolled Population|Overall enrolled population of patients: received at least one TAXUS Liberté Paclitaxel-Eluting Coronary Stent System in routine clinical practice, in conjunction with the use of prasugrel and aspirin.
932616|NCT00997438|B3|Baseline|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932617|NCT00997438|B2|Baseline|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932618|NCT00997438|B1|Baseline|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932619|NCT00997438|P3|Participant Flow|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932620|NCT00997438|P2|Participant Flow|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932621|NCT00997438|P1|Participant Flow|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932622|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932623|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932624|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932625|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932626|NCT00997438|O2|Outcome|MS - Relapsing Remitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932627|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932628|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932629|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932630|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932631|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932632|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932633|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932634|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932635|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932636|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932637|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932638|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932639|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932640|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932641|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932642|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932643|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932644|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932645|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932646|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932648|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932649|NCT00997438|O3|Outcome|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932650|NCT00997438|O2|Outcome|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932651|NCT00997438|O1|Outcome|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932652|NCT00997438|E3|Reported Event|Healthy Controls|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932653|NCT00997438|E2|Reported Event|MS - Relapsing Remmitting|"1200mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932654|NCT00997438|E1|Reported Event|MS - Secondary Progressive|"1200 mg of Lipoic acid supplement~Lipoic Acid: 300 mg Lipoic acid tablets from Vital Nutrients"
932655|NCT00997425|B1|Baseline|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
932656|NCT00997425|P1|Participant Flow|Arm 1 Door Cover; Floor Cover|The interventions were provided in the order door cover, then floor cover and then floor cover followed by door cover. After a baseline of 14 days the first Intervention (14 days) was provided, followed by baseline two for another 14 days followed by a second Intervention (14 days).
932694|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932657|NCT00997425|O2|Outcome|Floor Cover|"a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door.-"
932658|NCT00997425|O1|Outcome|Door Cover|- a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape
932659|NCT00997425|E1|Reported Event|Arm 1 Door Cover; Floor Cover|"Floor cover - a 4'X 4' black, rubberized mat superimposed with 2 white tape strips placed at 2 intervals on the cover, positioned anterior to the interior face of the equipped exit door, with the black and white strips running horizontal to the door. Door cover - a neutral-colored canvas cloth covering the entire interior surface of the equipped door, attached to the door using a combination of Velcro and double-faced tape"
932660|NCT00997373|B3|Baseline|Total|Total of all reporting groups
932661|NCT00997373|B2|Baseline|Control|No letrozole before hysterectomy
932662|NCT00997373|B1|Baseline|Letrozole Arm|Grade 1 or 2 endometrial cancer treated 3 weeks before hysterectomy of repeat biopsy. Letrozole 2.5 mg PO daily.
932663|NCT00997373|P2|Participant Flow|Control|No treatment prior to hysterectomy
932664|NCT00997373|P1|Participant Flow|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
932665|NCT00997373|O2|Outcome|Control|no treatemtn prior to hysterectomy
932666|NCT00997373|O1|Outcome|Letrozole|"letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery, generally about 3 weeks"
932667|NCT00997373|E2|Reported Event|Control|No treatment prior to hysterectomy
932668|NCT00997373|E1|Reported Event|Letrozole|"Letrozole 2.5 mg PO daily for 2-3 weeks prior to hysterectomy or re-biopsy.~Letrozole: 2.5 mg daily from the day of enrollment to the day before surgery (generally about 3 weeks) or to the day of repeat endometrial biopsy 9medical treatment arm)."
932669|NCT00997334|B1|Baseline|Erlotinib|Patients receive standard dose of erlotinib 150mg daily with cycle length of 28 days; Patients are treated until disease progression or until unaccepted drug toxicity.
932670|NCT00997334|P1|Participant Flow|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
932671|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
932672|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
932673|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
932674|NCT00997334|O1|Outcome|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
932675|NCT00997334|E1|Reported Event|Erlotinib|Erlotinib was given at a dose of 150mg orally once per day for 28 days (+/- 3 days); Patients are treated until disease progression or until unaccepted drug toxicity.
932676|NCT00997321|B3|Baseline|Total|Total of all reporting groups
932677|NCT00997321|B2|Baseline|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
932678|NCT00997321|B1|Baseline|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
932679|NCT00997321|P2|Participant Flow|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
932680|NCT00997321|P1|Participant Flow|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
932681|NCT00997321|O2|Outcome|Ketamine|median depth of sedation by the observers assesment of alertness scale in the ketamine group
934415|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
932683|NCT00997321|O2|Outcome|Ketamine|percentage of subjects reporting pain after the procedure who received ketamine
932684|NCT00997321|O1|Outcome|Propofol|percentage of subjects reporting pain after the procedure who received propofol
932685|NCT00997321|O2|Outcome|Ketamine|time in minutes from the start of the procedure until the return of baseline mental status
932686|NCT00997321|O1|Outcome|Propofol|time in minutes from the start of the procedure until the return of baseline mental status
932687|NCT00997321|O2|Outcome|Ketamine|percentage of participants with respiratory depression
932688|NCT00997321|O1|Outcome|Propofol|percentage of participants with respiratory depression
932689|NCT00997321|E2|Reported Event|Ketamine|ketamine 1 milligram per kilogram intravenous bolus to start procedure followed by 0.5 mg/kg every three minutes as needed for moderate procedural sedation
932690|NCT00997321|E1|Reported Event|Propofol|propofol 1 milligram per kilogram at the start of the procedure followed by 0.5 milligrams per kilogram every 3 minutes as needed for moderate procedural sedation
932691|NCT00997243|B1|Baseline|75 mg/m2 5-azacytidine (Vidaza, AZA) and 600 mg Lintuzumab|5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7 cycle 1 and all subsequent cycles. Lintuzumab 600mg as an IV infusion (flat dose for all), given on days 2, 7, 15, and 22 for cycle 1 and 600mg as an IV infusion, given every other week, twice during each cycle, including one dose given during AZA therapy for all other subsequent cycles.
932692|NCT00997243|P1|Participant Flow|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932693|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
951271|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
932695|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932696|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932697|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932698|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932699|NCT00997243|O1|Outcome|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932700|NCT00997243|E1|Reported Event|5-azacytidine and Lintuzumab|"Cycle 1- 5-azacytidine (Vidaza, AZA) 75mg/m2 IV/SC daily on days 1-7.~Subsequent Cycles (cycles to be repeated every 28 days) AZA 75mg/m2 IV/SC daily on days 1-7."
932701|NCT00997204|B3|Baseline|Total|Total of all reporting groups
932702|NCT00997204|B2|Baseline|Naive Patients|Patients who had never received icatibant and treated in both the Naive treatment phase and the Self-administered phase
932703|NCT00997204|B1|Baseline|Non-Naive Patients|Patients who previously treated with icatibant in clinical studies or with commercial Firazyr® and got the treatment during the self-administered phase
932704|NCT00997204|P2|Participant Flow|Non-Naive Subjects/ Self-administration Phase|Subjects who had received treatment for HAE with icatibant in previous clinical trials or had been previously treated with the marketed product Firazyr®, got Treatment of Acute HAE Attack with SC icatibant (30 mg)Self-Administered.
932705|NCT00997204|P1|Participant Flow|Naive Subjects/ Naive Treatment Phase|Patients who had never received icatibant before this phase, got treatment of Acute HAE Attack with SC icatibant (30 mg)Administered at Site by Health Care Provider.
932706|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
932707|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
932708|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
932709|NCT00997204|O3|Outcome|Subjects Who Self-administered Icatibant (Non-naive)|Non-Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
932710|NCT00997204|O2|Outcome|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
932711|NCT00997204|O1|Outcome|Naive Subjects Administered Icatibant by Health Care Provider|"The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.~3 subjects (of the original 25 enrolled in the naive treatment phase)self-administered icatibant while observed bu HCP, as opposed to having the HCP perform the injection. these data were not included in the naive treatment safety analyses."
932712|NCT00997204|E3|Reported Event|Subjects Who Self-administered Icatibant (Non-naive)|Non-naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
932713|NCT00997204|E2|Reported Event|Subjects Who Self-administered Icatibant (Naive)|Naive subjects self-administered the study drug at home or other site convenient to the subject, but not at the investigational site, nor under HCP-supervision.
932714|NCT00997204|E1|Reported Event|Naive Subjects Administered Icatibant by Health Care Provider|The first HAE attack of naïve subjects enrolled in the study was treated at the study site, where a Health Care Provider administered icatibant to the subject.
932715|NCT00997139|B1|Baseline|Treatment Group|Baseline culture positive for Staphylococcus aureus
932716|NCT00997139|P1|Participant Flow|All Subjects|
934416|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
932717|NCT00997139|O1|Outcome|MRSA|Subjects with Baseline culture positive for methicillin-resistant Staphylococcus aureus
932718|NCT00997139|O1|Outcome|MSSA|Baseline culture positive for methicillin-susceptible staphylococcus aureus
932719|NCT00997139|O1|Outcome|All Subjects|All subjects enrolled
932720|NCT00997139|E1|Reported Event|All Subjects|
932721|NCT00997126|B3|Baseline|Total|Total of all reporting groups
932722|NCT00997126|B2|Baseline|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
932723|NCT00997126|B1|Baseline|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932724|NCT00997126|P2|Participant Flow|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
932725|NCT00997126|P1|Participant Flow|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932726|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
932727|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932728|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
932729|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932730|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
933697|NCT00996632|E2|Reported Event|Conventional|Patients were operated by a conventional diatherm knife
932731|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932732|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
932733|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932734|NCT00997126|O2|Outcome|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
932735|NCT00997126|O1|Outcome|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932736|NCT00997126|E2|Reported Event|Alfentanil|"Sedation using alfentanil 10 ug/kg followed by 5 ug/kg prn sedation~Alfentanil: Alfentanil 10 ug/kg IV followed by 5 ug/kg prn sedation"
932737|NCT00997126|E1|Reported Event|Propofol|"Propofol 1m g/kg IV followed by 0.5 mg/kg IV prn sedation~Propofol: Propofol 1 mg/kg IV followed by 0.5 mg/kg prn sedation"
932738|NCT00997113|B3|Baseline|Total|Total of all reporting groups
932739|NCT00997113|B2|Baseline|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
932740|NCT00997113|B1|Baseline|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
932741|NCT00997113|P2|Participant Flow|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
932742|NCT00997113|P1|Participant Flow|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
932743|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
932744|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
932745|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
932746|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
932747|NCT00997113|O2|Outcome|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
932748|NCT00997113|O1|Outcome|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
932749|NCT00997113|E2|Reported Event|Propofol/Alfentanil|"Propofol with alfentanil for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation~alfentanil: alfentanil 10 ug/kg immediately prior to propofol dose"
932750|NCT00997113|E1|Reported Event|Propofol|"propofol only for deep procedural sedation~propofol: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation"
932751|NCT00997035|B3|Baseline|Total|Total of all reporting groups
932752|NCT00997035|B2|Baseline|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
932753|NCT00997035|B1|Baseline|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
932754|NCT00997035|P2|Participant Flow|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
932755|NCT00997035|P1|Participant Flow|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
932756|NCT00997035|O2|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
932821|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
933535|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
932757|NCT00997035|O1|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
932758|NCT00997035|O2|Outcome|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
932759|NCT00997035|O1|Outcome|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
932760|NCT00997035|O2|Outcome|Oral Placebo|oral placebo plus topical antifungal
932761|NCT00997035|O1|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal
932762|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agent
932763|NCT00997035|O1|Outcome|Oral Voriconazole|Oral voriconazole treated participants
932764|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
932765|NCT00997035|O1|Outcome|Oral Voriconazole|Oral voriconazole treated participants
932766|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
932767|NCT00997035|O1|Outcome|Oral Voriconazole|Oral Voriconazole plus topical antifungal agents
932768|NCT00997035|O2|Outcome|Oral Placebo|Oral Placebo plus topical antifungal agents
932769|NCT00997035|O1|Outcome|Oral Voriconazole|Oral Voriconazole plus topical antifungal agents
932770|NCT00997035|O2|Outcome|Oral Placebo|oral placebo plus topical antifungal agents
932771|NCT00997035|O1|Outcome|Oral Voriconazole|oral voriconazole plus topical antifungal agents
932772|NCT00997035|E2|Reported Event|Oral Voriconazole|"Voriconazole: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~400 mg BID PO on study day one (loading dose), then 200 mg BID PO until 3 weeks from enrollment for patients weighing greater than 50 kg. For patients 40-50 kg, the loading dose is 300 mg BID PO on study day 1, then 150 mg BID PO until 3 weeks from enrollment. For patients weighing <40 kg, the loading dose is 200 mg BID PO, then 100 mg BID PO until 3 weeks after enrollment."
932773|NCT00997035|E1|Reported Event|Placebo|"Placebo: 1% voriconazole (topical) plus 0.01% preservative, 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~5% natamycin (topical), 1 drop applied to the affected eye every one hour while awake for 1 week, then every 2 hours while awake until three weeks after enrollment.~Two tablets BID PO on study day one, then one tablet BID PO until 3 weeks from enrollment."
932839|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
933562|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
932774|NCT00996996|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932775|NCT00996996|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932776|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932777|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
934590|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
932778|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932779|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932780|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932781|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932782|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932783|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932854|NCT00996931|O1|Outcome|Lenalidomide|Six subjects received oral 2.5 mg daily for 12 weeks
932855|NCT00996931|E1|Reported Event|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
932856|NCT00996918|B6|Baseline|Total|Total of all reporting groups
932784|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932785|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932786|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932787|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932833|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932788|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932789|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932790|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932791|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932792|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932793|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932794|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932795|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932796|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932797|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932845|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932798|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932799|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932800|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932801|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932802|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932803|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932804|NCT00996996|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932805|NCT00996996|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) over 70 minutes, followed immediately by 5 millicurie (mCi) iodine I-131 tositumomab (contained in 35 mg tositumomab) infused over 30 minutes. Therapeutic dose (administered only once 7 to 14 days after the dosimetric dose): 450 mg unlabeled tositumomab administered IV over 70 minutes, followed immediately by iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV infused over 30 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
932806|NCT00996944|B3|Baseline|Total|Total of all reporting groups
932807|NCT00996944|B2|Baseline|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932808|NCT00996944|B1|Baseline|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932809|NCT00996944|P2|Participant Flow|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932810|NCT00996944|P1|Participant Flow|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932811|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932812|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of investigational product (IP) was upward titrated from 0.25 milligrams (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression–Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932813|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932814|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932815|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
933563|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
932816|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932817|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932818|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932819|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932820|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
934591|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
932822|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932823|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932824|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932825|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932826|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932827|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
933564|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
932828|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932829|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932830|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932831|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932832|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932867|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932834|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932835|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932836|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932837|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932838|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932882|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
934417|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
932840|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932841|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932842|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932843|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932844|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
933536|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
932846|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932847|NCT00996944|O2|Outcome|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932848|NCT00996944|O1|Outcome|Ropinirole IR-Ropinirole IR|Participants received immediate-release (IR) tablets of ropinirole once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 milligram (mg)/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed Clinical Global Impression – Improvement [CGI-I]) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932849|NCT00996944|E2|Reported Event|Placebo-Ropinirole IR|Participants received matching placebo to ropinirole IR in the double-blind treatment period. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants received ropinirole IR tablets in the same way as in the ropinirole IR-ropinirole IR group.
932850|NCT00996944|E1|Reported Event|Ropinirole IR-Ropinirole IR|Participants received ropinirole IR tablets once daily for 12 weeks in the double-blind treatment period. The dose of IP was upward titrated from 0.25 mg/day to 0.5 mg/day at an interval of at least 1 week, followed by upward titration in increments of 0.5 mg/day at intervals of at least 1 week until sufficient efficacy was obtained (targeting “much improved” or “very much improved” in the investigator/subinvestigator-assessed CGI-I) without a safety/tolerability problem, although the dose did not exceed 3 mg/day. All participants completing the double-blind treatment period were eligible to continue in the open-label long-term treatment period. In the open-label period, participants were to receive ropinirole IR tablets once daily for 52 weeks with a similar upward titration method as in the double-blind treatment period.
932851|NCT00996931|B1|Baseline|Lenalidomide|Six patients will receive 2.5 mg oral daily for 12 weeks
932852|NCT00996931|P1|Participant Flow|Lenalidomide|Six patients will receive oral 2.5 mg daily for 12 weeks
932853|NCT00996931|O1|Outcome|Lenalidomide|oral 25 mg daily for 12 weeks
934418|NCT00995345|O1|Outcome|Placebo|Tablet
932857|NCT00996918|B5|Baseline|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932858|NCT00996918|B4|Baseline|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932859|NCT00996918|B3|Baseline|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932860|NCT00996918|B2|Baseline|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932861|NCT00996918|B1|Baseline|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932862|NCT00996918|P5|Participant Flow|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932863|NCT00996918|P4|Participant Flow|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932864|NCT00996918|P3|Participant Flow|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932865|NCT00996918|P2|Participant Flow|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932866|NCT00996918|P1|Participant Flow|Placebo/Bapineuzumab 0.5 Milligram/Kilogram(mg/kg)|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
933584|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
932868|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932869|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932870|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932871|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932872|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932873|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932874|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932875|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932876|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932877|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932878|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932879|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932880|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932881|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
933668|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
932883|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932884|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932885|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932886|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932887|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932888|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932889|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932890|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932891|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932892|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932893|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
934592|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
932894|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932895|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932896|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932897|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932898|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932899|NCT00996918|O5|Outcome|Bapineuzumab 2.0 mg/kg/ Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932900|NCT00996918|O4|Outcome|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932901|NCT00996918|O3|Outcome|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932902|NCT00996918|O2|Outcome|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932903|NCT00996918|O1|Outcome|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932904|NCT00996918|E5|Reported Event|Bapineuzumab 2.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants originally randomized to 2.0 mg/kg bapineuzumab were reassigned to the 1.0 mg/kg dose level after discontinuation of 2.0 mg/kg dose level in the base study and continued the 1.0 mg/kg dose in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932905|NCT00996918|E4|Reported Event|Bapineuzumab 1.0 mg/kg/Bapineuzumab 1.0 mg/kg|Participants received 1.0 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932906|NCT00996918|E3|Reported Event|Placebo/Bapineuzumab 1.0 mg/kg|Participants received placebo in the base study and 1.0 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932907|NCT00996918|E2|Reported Event|Bapineuzumab 0.5 mg/kg/ Bapineuzumab 0.5 mg/kg|Participants received 0.5 mg/kg bapineuzumab in both the base and extension studies. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932908|NCT00996918|E1|Reported Event|Placebo/Bapineuzumab 0.5 mg/kg|Participants received placebo in the base study and 0.5 mg/kg bapineuzumab in this extension study. In this extension study bapineuzumab was administered by IV infusion approximately every 13 weeks up to Week 195.
932909|NCT00996892|B1|Baseline|All Participants|All participants who received cobimetinib and pictilisib in any dose combination until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932910|NCT00996892|P20|Participant Flow|S2A Expansion: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 2A (S2A) expansion cohort: Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with KRAS mutant NSCLC; EGFR T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; KRAS mutant CRC, and KRAS mutant endometrioid carcinoma.
932911|NCT00996892|P19|Participant Flow|S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 2 (S2) expansion cohort: Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This indication specific cohort included participants with Kirsten rat sarcoma viral oncogene homolog (KRAS) mutant non–small cell lung cancer (NSCLC); epidermal growth factor receptor (EGFR) T790M mutant and EGFR inhibitor-progressing NSCLC; pancreatic adenocarcinoma; and KRAS mutant colorectal cancer (CRC).
932912|NCT00996892|P18|Participant Flow|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort DX (S1B CDX): Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932913|NCT00996892|P17|Participant Flow|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort CX (S1B CCX): Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932961|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932914|NCT00996892|P16|Participant Flow|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Stage 1B Cohort BX (S1B CBX): Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932915|NCT00996892|P15|Participant Flow|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1B Cohort AX (S1B CAX): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932916|NCT00996892|P14|Participant Flow|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort G (S1A CG): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932917|NCT00996892|P13|Participant Flow|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort F (S1A CF): Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932918|NCT00996892|P12|Participant Flow|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Stage 1A Cohort E (S1A CE): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932919|NCT00996892|P11|Participant Flow|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort D (S1A CD): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932920|NCT00996892|P10|Participant Flow|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort C (S1A CC): Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932921|NCT00996892|P9|Participant Flow|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Stage 1A Cohort B (S1A CB): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932922|NCT00996892|P8|Participant Flow|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Stage 1A Cohort A (S1A CA): Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933565|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933669|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
932923|NCT00996892|P7|Participant Flow|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6A (S1 C6A): Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932924|NCT00996892|P6|Participant Flow|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 6 (S1 C6): Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932925|NCT00996892|P5|Participant Flow|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Stage 1 Cohort 5 (S1 C5): Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932926|NCT00996892|P4|Participant Flow|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 4 (S1 C4): Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932927|NCT00996892|P3|Participant Flow|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 3 (S1 C3): Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932928|NCT00996892|P2|Participant Flow|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Stage 1 Cohort 2 (S1 C2): Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932979|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932929|NCT00996892|P1|Participant Flow|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Stage 1 Cohort 1 (S1 C1): Participants received a single oral dose of pictilisib 80 milligrams (mg) capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932930|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932931|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932932|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932933|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932934|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932935|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932936|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933336|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932937|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
932938|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932939|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932940|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932941|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932942|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932943|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932944|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
932962|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
933698|NCT00996632|E1|Reported Event|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
932945|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932946|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932947|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932948|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932949|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932950|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933554|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
950880|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
932951|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932952|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932953|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932954|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932955|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
932956|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932957|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932958|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932959|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932960|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932963|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932964|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932965|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932966|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932967|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932968|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932969|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932970|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932971|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932972|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932973|NCT00996892|O11|Outcome|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
932974|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932975|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932976|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932977|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932978|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932980|NCT00996892|O4|Outcome|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
932981|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932982|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932983|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932984|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932985|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932986|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932987|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932988|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932989|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932990|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932991|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932992|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932993|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932994|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
951272|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
932995|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932996|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932997|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932998|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
932999|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933000|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933001|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933002|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933003|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933004|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933005|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933006|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933007|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933008|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933009|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933010|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933011|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933012|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933013|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933014|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933015|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933016|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933017|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933018|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933019|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933020|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933021|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933022|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933023|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933024|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933025|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933026|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933027|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933028|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933029|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933030|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933031|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933032|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933033|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933034|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933035|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933036|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933037|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933038|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933039|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933040|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933041|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933042|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933043|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933044|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933045|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933046|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933047|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933048|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933049|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933050|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933051|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933052|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933053|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933054|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933055|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933056|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933057|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933058|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933059|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933060|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933061|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933062|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933063|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933064|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933065|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933066|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933067|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933068|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933069|NCT00996892|O5|Outcome|S2A Endometrioid: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS mutant endometrioid carcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933070|NCT00996892|O4|Outcome|S2A Pancreatic: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933071|NCT00996892|O3|Outcome|S2A KRAS CRC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS CRC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933072|NCT00996892|O2|Outcome|S2A KRAS NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933073|NCT00996892|O1|Outcome|S2A EGFR T790M NSCLC: 125 mg Cobimetinib + 180 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933074|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933075|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933076|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933077|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933078|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933079|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933585|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933080|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933081|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933082|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933083|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933084|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933085|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933086|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933087|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933555|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
950881|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
933088|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933089|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933090|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933091|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933092|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933093|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933094|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933095|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933096|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933097|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
934593|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
933098|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933099|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933100|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933101|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933102|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933103|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933104|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933105|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933106|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933107|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933108|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933109|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933110|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933111|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933112|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933113|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933114|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933115|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
934594|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
933116|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933117|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933118|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933119|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933120|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933121|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933122|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933123|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933124|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933125|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933126|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933127|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933128|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933129|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933130|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933131|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933132|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933133|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
934595|NCT00994461|E3|Reported Event|Placebo|Placebo tablet three times a day with meal for 2 weeks
933134|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933135|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933136|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933137|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933138|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933139|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933140|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933141|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933142|NCT00996892|O4|Outcome|S2 Pancreatic: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with pancreatic adenocarcinoma received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933143|NCT00996892|O3|Outcome|S2 KRAS CRC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS CRC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933144|NCT00996892|O2|Outcome|S2 KRAS NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with KRAS NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933145|NCT00996892|O1|Outcome|S2 EGFR T790M NSCLC: 40 mg Cobimetinib + 100 mg Pictilisib|Participants with EGFR T790M mutant and EGFR inhibitor-progressing NSCLC received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933146|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933147|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933148|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933149|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933150|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933151|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933152|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933153|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933154|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933155|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933156|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933157|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933158|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933556|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933557|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933159|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933160|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933161|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933162|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933163|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933164|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933165|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933166|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933167|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933168|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933586|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
934697|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
933169|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933170|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933171|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933172|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933173|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933174|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933175|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933176|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933177|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933178|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933179|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933180|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933181|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933182|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933183|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933184|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933185|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933587|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
934698|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
933186|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933187|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933188|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933189|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933190|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933191|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933192|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933193|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933194|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933195|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933196|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933197|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933198|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933199|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933200|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933201|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933202|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933588|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
951273|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
933203|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933204|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933205|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933206|NCT00996892|O4|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933207|NCT00996892|O3|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933208|NCT00996892|O2|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933209|NCT00996892|O1|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933210|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933211|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933212|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933213|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933214|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933215|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933216|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933217|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933218|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933219|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933220|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
934699|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
933221|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933222|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933223|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933224|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933225|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933226|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933227|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933664|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933228|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933229|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933230|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933231|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933232|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933233|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933234|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933235|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933236|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933237|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933238|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933589|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
951274|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
933239|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933240|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933241|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933242|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933243|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933244|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933245|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933246|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933247|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933248|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933249|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933250|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933251|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933252|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933253|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933254|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933255|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933256|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933590|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
951275|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
933257|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933258|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933259|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933260|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933261|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933262|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933263|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933264|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933265|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933266|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933267|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933268|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933269|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933270|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933271|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933272|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933273|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933274|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933591|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
951276|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
933275|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933276|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933277|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933278|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933279|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933280|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933281|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933282|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933283|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933284|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933285|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933286|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933287|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933288|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933289|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933290|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933291|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933292|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933592|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
951277|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
933293|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933294|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933295|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933296|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933297|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933298|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933299|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933300|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933301|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933302|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933303|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933304|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933305|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933306|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933307|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933308|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933309|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933310|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933593|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
951278|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
933311|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933312|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933313|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933314|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933315|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933316|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933317|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933318|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933319|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933320|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933321|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933322|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933323|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933324|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933325|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933326|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933327|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933328|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933594|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
951279|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
933329|NCT00996892|O7|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933330|NCT00996892|O6|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933331|NCT00996892|O5|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933332|NCT00996892|O4|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933333|NCT00996892|O3|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933334|NCT00996892|O2|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933335|NCT00996892|O1|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933337|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933338|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933339|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933340|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933341|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933342|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933343|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933344|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933537|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
933345|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933346|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933347|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933348|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933349|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933350|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933351|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933352|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933353|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933354|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933355|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933356|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933357|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933358|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933538|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933689|NCT00996632|B2|Baseline|Conventional|Patients were operated by a conventional diatherm knife
933359|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933360|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933361|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933362|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933363|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933364|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933365|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933366|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933367|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933368|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933369|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933370|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933371|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933372|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933539|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
934700|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
933373|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933374|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933375|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933376|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933377|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933378|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933379|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933380|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933381|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933382|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933383|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933384|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933385|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933386|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933540|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
934701|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
933387|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933388|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933389|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933390|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933391|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933392|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933393|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933394|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933395|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933396|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933397|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933398|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933399|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933400|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933541|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
934702|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
933401|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933402|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933403|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933404|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933405|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933406|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933407|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933408|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933409|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933410|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933411|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933412|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933413|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933414|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933542|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
934703|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
933415|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933416|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933417|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933418|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933419|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933420|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933421|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933422|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933423|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933424|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933425|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933426|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933427|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933428|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933581|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
934704|NCT00994214|E9|Reported Event|Overall - Part B|
933429|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933430|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933431|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933432|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933433|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933434|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933435|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933436|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933437|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933438|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933439|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933440|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933441|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933442|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933582|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
934705|NCT00994214|E8|Reported Event|Part B: Arm D: BIM 23A760 6 mg|
933443|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933444|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933445|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933446|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933447|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933448|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933449|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933450|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933451|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933452|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933453|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933454|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933455|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933456|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933583|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
934706|NCT00994214|E7|Reported Event|Part B: Arm C: BIM 23A760 4 mg|
933457|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933458|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933459|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933460|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933461|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933558|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933559|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933462|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933463|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933464|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933465|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933466|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933467|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933495|NCT00996892|O4|Outcome|S1 C4: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933468|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933469|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933470|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933471|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
950882|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
933472|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933473|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933474|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933475|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933476|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933477|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933511|NCT00996892|E6|Reported Event|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
934707|NCT00994214|E6|Reported Event|Part B: Arm B: BIM 23A760 2 mg|
933478|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933479|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933480|NCT00996892|O1|Outcome|All Participants - Stages 1, 1A, 1B|All participants who received cobimetinib and pictilisib in any dose combination during Stages 1, 1A, and 1B, until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933481|NCT00996892|O18|Outcome|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933482|NCT00996892|O17|Outcome|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933560|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
950883|NCT00950911|B3|Baseline|Total|Total of all reporting groups
933483|NCT00996892|O16|Outcome|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933484|NCT00996892|O15|Outcome|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933485|NCT00996892|O14|Outcome|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933486|NCT00996892|O13|Outcome|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933487|NCT00996892|O12|Outcome|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933488|NCT00996892|O11|Outcome|S1A CD: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933489|NCT00996892|O10|Outcome|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933490|NCT00996892|O9|Outcome|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933491|NCT00996892|O8|Outcome|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933492|NCT00996892|O7|Outcome|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933493|NCT00996892|O6|Outcome|S1 C6: 60 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933494|NCT00996892|O5|Outcome|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933533|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933496|NCT00996892|O3|Outcome|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933497|NCT00996892|O2|Outcome|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933498|NCT00996892|O1|Outcome|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933499|NCT00996892|E18|Reported Event|S1B CDX: 60 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933500|NCT00996892|E17|Reported Event|S1B CCX: 60 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 60 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933501|NCT00996892|E16|Reported Event|S1B CBX: 40 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 180 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933502|NCT00996892|E15|Reported Event|S1B CAX: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 7 and then from Days 15 to 21 in continuous 28-day cycles. Participants were off study drugs from Days 8 to 14 and from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933503|NCT00996892|E14|Reported Event|S1A CG: 150 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933504|NCT00996892|E13|Reported Event|S1A CF: 150 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 150 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933505|NCT00996892|E12|Reported Event|S1A CE: 125 mg Cobimetinib + 245 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 245 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933506|NCT00996892|E11|Reported Event|S1A CD/S2A Expension: 125 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants form S1A CD as well as S2A expansion cohort.
933507|NCT00996892|E10|Reported Event|S1A CC: 125 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 125 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933508|NCT00996892|E9|Reported Event|S1A CB: 100 mg Cobimetinib + 180 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 180 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933509|NCT00996892|E8|Reported Event|S1A CA: 100 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 100 mg capsules on Days 1, 4, 8, 11, 15, and 18 and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933510|NCT00996892|E7|Reported Event|S1 C6A: 80 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 80 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933534|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933690|NCT00996632|B1|Baseline|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
933512|NCT00996892|E5|Reported Event|S1 C5: 40 mg Cobimetinib + 130 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 130 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933513|NCT00996892|E4|Reported Event|S1 C4/S2 Expansion: 40 mg Cobimetinib + 100 mg Pictilisib|Participants received cobimetinib 40 mg capsules and pictilisib 100 mg capsules from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28 in continuous 28-day cycles. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met. This arm included participants from S1 C4 as well as S2 expansion cohort.
933514|NCT00996892|E3|Reported Event|S1 C3: 40 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 40 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933515|NCT00996892|E2|Reported Event|S1 C2: 20 mg Cobimetinib + 100 mg Pictilisib|Participants received a single oral dose of pictilisib 100 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933561|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933665|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933516|NCT00996892|E1|Reported Event|S1 C1: 20 mg Cobimetinib + 80 mg Pictilisib|Participants received a single oral dose of pictilisib 80 mg capsules on Day 1 of Cycle 1 and a single oral dose of cobimetinib 20 mg capsules on Day 3 of Cycle 1, followed by continuous 21-day dosing with both cobimetinib and pictilisib at same doses from Days 8 to 28 and then 7 days off study drugs from Days 29 to 35 (Cycle 1 = 35 days). In subsequent cycles (28-day cycles), participants received 21-day dosing with both cobimetinib and pictilisib at same doses from Days 1 to 21 and then 7 days off study drugs from Days 22 to 28. Treatment continued until disease progression, unacceptable toxicity, or any other discontinuation criterion was met.
933517|NCT00996801|B7|Baseline|Total|Total of all reporting groups
933518|NCT00996801|B6|Baseline|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933519|NCT00996801|B5|Baseline|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933520|NCT00996801|B4|Baseline|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933521|NCT00996801|B3|Baseline|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933522|NCT00996801|B2|Baseline|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933523|NCT00996801|B1|Baseline|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933524|NCT00996801|P6|Participant Flow|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933525|NCT00996801|P5|Participant Flow|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933526|NCT00996801|P4|Participant Flow|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933527|NCT00996801|P3|Participant Flow|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933528|NCT00996801|P2|Participant Flow|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933529|NCT00996801|P1|Participant Flow|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933530|NCT00996801|O6|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933531|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
933532|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933691|NCT00996632|P2|Participant Flow|Conventional|Patients were operated by a conventional diatherm knife
933543|NCT00996801|O5|Outcome|MK-5442 15 mg|"Participants were initially randomized to receive oral, once-daily MK-5442 15 mg and once-weekly matching placebo to alendronate for 12 months.~The MK-5442 15-mg treatment arm was discontinued as a result of Amendment 1 and thus no outcome analyses were performed."
933544|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933545|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933546|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933547|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933548|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933549|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933550|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933551|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933552|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933553|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933566|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933567|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933568|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933569|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933570|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933571|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933572|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933573|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933574|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933575|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933576|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933577|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933578|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933579|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933580|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933595|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933596|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933597|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933598|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933599|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933600|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933601|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933602|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933603|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933604|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933605|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933606|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933607|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933608|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933609|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933610|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933611|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933612|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933613|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933614|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933615|NCT00996801|O3|Outcome|MK-5442 7.5 mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933616|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933617|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933666|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933618|NCT00996801|O5|Outcome|Alendronate 70 mg|Participants were randomized to receive oral, once-weekly alendronate 70 mg plus once-daily matching placebo to MK-5442 for 12 months.
933619|NCT00996801|O4|Outcome|MK-5442 10 mg|Participants were randomized to receive oral, once-daily MK-5442 10 mg and once-weekly matching placebo to alendronate for 12 months.
933620|NCT00996801|O3|Outcome|MK-5442 7.5mg|Participants were randomized to receive oral, once-daily MK-5442 7.5 mg and once-weekly matching placebo to alendronate for 12 months.
933621|NCT00996801|O2|Outcome|MK-5442 5 mg|Participants were randomized to receive oral, once-daily MK-5442 5 mg and once-weekly matching placebo to alendronate for 12 months.
933622|NCT00996801|O1|Outcome|Placebo|Participants received oral matching placebo for MK-5442 or alendronate, based on their randomization to active drug or comparator arm.
933623|NCT00996801|E6|Reported Event|Alendronate 70 mg|Participants received 70 mg alendronate (orally, once-weekly) plus matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933624|NCT00996801|E5|Reported Event|MK-5442 15 mg|Participants received 15 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933625|NCT00996801|E4|Reported Event|MK-5442 10 mg|Participants received 10 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933626|NCT00996801|E3|Reported Event|MK-5442 7.5 mg|Participants received 7.5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933627|NCT00996801|E2|Reported Event|MK-5442 5 mg|Participants received 5 mg of MK-5442 (orally, once-daily) plus matching placebo to alendronate (administered orally, once-weekly) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933628|NCT00996801|E1|Reported Event|Placebo|Participants received either matching placebo to alendronate (administered orally, once-weekly) or matching placebo to MK-5442 (administered orally, once-daily) for 12 months. Participants also received supplemental vitamin D3 and calcium (as needed) during treatment.
933629|NCT00996775|B3|Baseline|Total|Total of all reporting groups
933692|NCT00996632|P1|Participant Flow|Ultrasonic|Patients were operated using an ultrasonic knife (Ultracision Ethicon TM)
933630|NCT00996775|B2|Baseline|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933631|NCT00996775|B1|Baseline|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933632|NCT00996775|P2|Participant Flow|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933633|NCT00996775|P1|Participant Flow|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933634|NCT00996775|O2|Outcome|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933635|NCT00996775|O1|Outcome|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933636|NCT00996775|E2|Reported Event|Arm 2|"Group receiving treatment-as-usual plus a brief alcohol intervention~brief alcohol intervention: computer-delivered intervention consisting of an assessment and individualized feedback component.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933637|NCT00996775|E1|Reported Event|Arm 1|"Group receiving treatment-as-usual.~Treatment-as-Usual: Treatment-as-usual for positive AUDIT-C screens conducted in the GMC at the VA Palo Alto Health Care System."
933638|NCT00996736|B3|Baseline|Total|Total of all reporting groups
933639|NCT00996736|B2|Baseline|Topical Voriconazole|
933640|NCT00996736|B1|Baseline|Topical Natamycin|
933641|NCT00996736|P2|Participant Flow|Topical Voriconazole|
933642|NCT00996736|P1|Participant Flow|Topical Natamycin|
933643|NCT00996736|O2|Outcome|Topical Voriconazole|
933644|NCT00996736|O1|Outcome|Topical Natamycin|
933645|NCT00996736|O2|Outcome|Topical Voriconazole|
933646|NCT00996736|O1|Outcome|Topical Natamycin|
933647|NCT00996736|O2|Outcome|Topical Voriconazole|
933648|NCT00996736|O1|Outcome|Topical Natamycin|
933649|NCT00996736|O2|Outcome|Topical Voriconazole|
933650|NCT00996736|O1|Outcome|Topical Natamycin|
933651|NCT00996736|O2|Outcome|Topical Voriconazole|
933652|NCT00996736|O1|Outcome|Topical Natamycin|
933653|NCT00996736|O2|Outcome|Topical Voriconazole|
933654|NCT00996736|O1|Outcome|Topical Natamycin|
933655|NCT00996736|O2|Outcome|Topical Voriconazole|
933656|NCT00996736|O1|Outcome|Topical Natamycin|
933657|NCT00996736|E2|Reported Event|Topical Voriconazole|
933658|NCT00996736|E1|Reported Event|Topical Natamycin|
933659|NCT00996658|B3|Baseline|Total|Total of all reporting groups
933660|NCT00996658|B2|Baseline|Linagliptin 5 mg Tablet|
933661|NCT00996658|B1|Baseline|Placebo Tablet|
933662|NCT00996658|P2|Participant Flow|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933663|NCT00996658|P1|Participant Flow|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
951407|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
933670|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933671|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933672|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933673|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933674|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933675|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933676|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933677|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933678|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933679|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933680|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933681|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933682|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933683|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933684|NCT00996658|O2|Outcome|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933685|NCT00996658|O1|Outcome|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933686|NCT00996658|E2|Reported Event|Linagliptin 5 mg Tablet|Linagliptin 5 mg (milligrams) tablet given by mouth once daily
933687|NCT00996658|E1|Reported Event|Placebo Tablet|Placebo matching linagliptin 5 mg tablet
933688|NCT00996632|B3|Baseline|Total|Total of all reporting groups
934708|NCT00994214|E5|Reported Event|Overall - Part A|
933699|NCT00996606|B1|Baseline|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933700|NCT00996606|P1|Participant Flow|Tocilizumab in Active Rheumatoid Arthritis (RA)|Participants with active RA received tocilizumab as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933701|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933702|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933703|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933704|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933705|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933706|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933707|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933708|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933709|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933710|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933711|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933712|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933713|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933714|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933715|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933716|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933717|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
951408|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
933718|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933719|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933720|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933721|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933722|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933723|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933724|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933725|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933726|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
934709|NCT00994214|E4|Reported Event|Part A: Arm D: BIM 23A760 6 mg|
933727|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933728|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933729|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933730|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933731|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933732|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933733|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933734|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933735|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933736|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933737|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933738|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933739|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933740|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933741|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933742|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933743|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933744|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933745|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
951409|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
933746|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933747|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933748|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933749|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933750|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933751|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933752|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933753|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933754|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
934002|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933755|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933756|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933757|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933758|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933759|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933760|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933761|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933762|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933763|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933764|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933765|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933766|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933767|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933768|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933769|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933770|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933771|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933772|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933773|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933774|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933775|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933776|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933777|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933778|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933779|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933780|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933781|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933782|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
934003|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933783|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933784|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933785|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933786|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933787|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933788|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933789|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933790|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933791|NCT00996606|O1|Outcome|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933792|NCT00996606|E1|Reported Event|Tocilizumab in Active RA|Participants with active RA received tocilizumab as 8 mg/kg via IV infusion every 4 weeks. A total of 12 infusions were given from Baseline to Week 44, and participants were assessed through Week 48.
933793|NCT00996593|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933794|NCT00996593|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933795|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
934419|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
933796|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933797|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933798|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933847|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933799|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933800|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933801|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933802|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933803|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933804|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933832|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933833|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933805|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933806|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933807|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933808|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
934710|NCT00994214|E3|Reported Event|Part A: Arm C: BIM 23A760 4 mg|
933809|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933810|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933811|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933812|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933813|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933814|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933815|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933816|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933817|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933818|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
934711|NCT00994214|E2|Reported Event|Part A: Arm B: BIM 23A760 2 mg|
933819|NCT00996593|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933820|NCT00996593|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
933821|NCT00996580|B1|Baseline|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933822|NCT00996580|P1|Participant Flow|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933823|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933824|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
933825|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933826|NCT00996580|O1|Outcome|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933827|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933828|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
933829|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933830|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933831|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
933834|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
934420|NCT00995345|O4|Outcome|Dose 3: KRP-104|100 mg QD
933835|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933836|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933837|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
933838|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933839|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933840|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
933841|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933842|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933843|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
933844|NCT00996580|O1|Outcome|DR-103: Total|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933845|NCT00996580|O3|Outcome|DR-103: >=90kg Subpopulation|Subpopulation of the total participants who weighed >=90 kg during the screening visit.
933846|NCT00996580|O2|Outcome|DR-103: <90 kg Subpopulation|Subpopulation of the total participants who weighed <90 kg during the screening visit.
933848|NCT00996580|E1|Reported Event|DR-103|"Four 91-day cycles of the DR-103 regimen:~42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;~21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;~21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;~7 days of 10 mcg EE."
933849|NCT00996502|B1|Baseline|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
933850|NCT00996502|P1|Participant Flow|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
933851|NCT00996502|O1|Outcome|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
933852|NCT00996502|E1|Reported Event|Combination Regimen|"Bevacizumab, Erlotinib, Docetaxel, Prednisone (dose escalation)~Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle, 15mg/kg of Bevacizumab every 3 weeks, 200 mg of Erlotinib PO daily days 2-16, 5 mg of Prednisone PO bid~Docetaxel: Phase I:~Cohort 1: 55mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 2: 65mg/m2 of Docetaxel on Day 1 of the cycle~Cohort 3: 75mg/m2 of Docetaxel on Day 1 of the cycle~Bevacizumab: 15mg/kg of Bevacizumab every 3 weeks~Erlotinib: 200 mg of Erlotinib PO daily days 2-16~Prednisone: 5 mg of Prednisone PO bid"
933853|NCT00996476|B6|Baseline|Total|Total of all reporting groups
933854|NCT00996476|B5|Baseline|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933855|NCT00996476|B4|Baseline|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933952|NCT00996372|B2|Baseline|Placebo|
933953|NCT00996372|B1|Baseline|Flibanserin|
933954|NCT00996372|P2|Participant Flow|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
933856|NCT00996476|B3|Baseline|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933857|NCT00996476|B2|Baseline|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933858|NCT00996476|B1|Baseline|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933859|NCT00996476|P5|Participant Flow|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933860|NCT00996476|P4|Participant Flow|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933861|NCT00996476|P3|Participant Flow|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933862|NCT00996476|P2|Participant Flow|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933905|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933863|NCT00996476|P1|Participant Flow|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933864|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933865|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933866|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933867|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933868|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933869|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
933870|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
933871|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
933872|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
933873|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
933874|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
933875|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933876|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933955|NCT00996372|P1|Participant Flow|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
933956|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
933877|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933878|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933879|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933880|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933881|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933882|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933883|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933884|NCT00996476|O6|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933885|NCT00996476|O5|Outcome|All TMC435|TMC435 50 mg or 100 mg capsule orally once daily for 12 or 24 weeks
934001|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934712|NCT00994214|E1|Reported Event|Part A: Arm A: BIM 23A760 1 mg|
933886|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933887|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933888|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933889|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933890|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933891|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933892|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933893|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933894|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933895|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933957|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
933958|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
933896|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933897|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933898|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933899|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933900|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933901|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933902|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933903|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933904|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933906|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933907|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933908|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933909|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933910|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933911|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933912|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933913|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933914|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933915|NCT00996476|O5|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933916|NCT00996476|O4|Outcome|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933917|NCT00996476|O3|Outcome|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933918|NCT00996476|O2|Outcome|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933919|NCT00996476|O1|Outcome|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933920|NCT00996476|O3|Outcome|PR48 Control|Participants received PegIFNα-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933921|NCT00996476|O2|Outcome|TMC435 100 mg|Participants who received TMC435 100 mg in Treatment Groups TMC12/PR24 100 mg and TMC24/PR24 100 mg
933922|NCT00996476|O1|Outcome|TMC435 50 mg|Participants who received TMC435 50 mg in Treatment Groups TMC12/PR24 50 mg and TMC24/PR24 50 mg
933923|NCT00996476|E5|Reported Event|PR48 Control|Participants received PegIFNa-2a and ribavirin (PR) for 48 weeks (PR48 control group)
933924|NCT00996476|E4|Reported Event|TMC24/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933925|NCT00996476|E3|Reported Event|TMC24/PR24 50 mg|Participants received TMC435 50 mg once daily plus PegIFNa-2a and ribavirin (PR) for 24 weeks. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435, PR) at Week 24. All other participants continued PR until Week 48.
933926|NCT00996476|E2|Reported Event|TMC12/PR24 100 mg|Participants received TMC435 100 mg once daily plus PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24. Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933927|NCT00996476|E1|Reported Event|TMC12/PR24 50 mg|Participants received TMC435 50 mg once daily with PegIFNa-2a and ribavirin (PR) for 12 weeks followed by PR until Week 24 Participants who achieved plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels <1.4 log10 IU/mL at Week 4 and had undetectable plasma HCV RNA at Weeks 12, 16 and 20, discontinued all study treatment (TMC435 and PR) at Week 24. All other participants continued PR until Week 48.
933928|NCT00996437|B3|Baseline|Total|Total of all reporting groups
933929|NCT00996437|B2|Baseline|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933930|NCT00996437|B1|Baseline|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933931|NCT00996437|P2|Participant Flow|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933932|NCT00996437|P1|Participant Flow|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933933|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933934|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933935|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933936|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933937|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933938|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933939|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933940|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933941|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933942|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933943|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933944|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933945|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933946|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933947|NCT00996437|O2|Outcome|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933948|NCT00996437|O1|Outcome|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933949|NCT00996437|E2|Reported Event|Saline Injection|Saline : Saline injection of 0.5mg at baseline, 4 and 8 weeks
933950|NCT00996437|E1|Reported Event|Ranibizumab|Ranibizumab : Intravitreal injection of 0.5 mg ranibizumab (Lucentis™) at baseline, 4 and 8 weeks
933951|NCT00996372|B3|Baseline|Total|Total of all reporting groups
933959|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
933960|NCT00996372|O2|Outcome|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
933961|NCT00996372|O1|Outcome|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
933962|NCT00996372|E2|Reported Event|Placebo|"placebo one tablet po qd~placebo : patients will be randomized to flibanserin or placebo in a double-blind manner"
933963|NCT00996372|E1|Reported Event|Flibanserin 100mg|"flibanserin 100mg po qd~flibanserin : patients will be randomized to flibanserin or placebo in a double-blind manner"
933964|NCT00996346|B4|Baseline|Total|Total of all reporting groups
933965|NCT00996346|B3|Baseline|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
933966|NCT00996346|B2|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
933967|NCT00996346|B1|Baseline|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
933968|NCT00996346|P3|Participant Flow|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
933969|NCT00996346|P2|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
933970|NCT00996346|P1|Participant Flow|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
934713|NCT00994123|B4|Baseline|Total|Total of all reporting groups
933971|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).~In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.~The treatment consists of:~Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.~The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
933972|NCT00996346|O1|Outcome|Irinotecan&Temsirolimus:All Arms|"Data from the dose escalation in all three arms is used to calculate the maximum tolerated dose (MTD).~In all three arms, Irinotecan and temsirolimus will be repeated weekly x 3 doses followed by one week of rest. One course will be four weeks.~The treatment consists of:~Irinotecan at 50 - 80 mg/m2 weekly, for three weeks + Temsirolimus at 15 - 25 mg weekly, for three weeks.~The specific doses of Irinotecan are 50, 65, or 80 mg/m2 The specific doses of Temsirolimus are 15, 20, or 25 mg"
933973|NCT00996346|E3|Reported Event|Irinotecan&Temsirolimus:Arm 2, Level 1|Arm 1, Level 2: Irinotecan intravenously at 50 mg/m2 + Temsirolimus intravenously at 25 mg on a weekly basis for 3 consecutive doses followed by one week of rest.
933974|NCT00996346|E2|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 2|"Arm 1, Level 2: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 20 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
933975|NCT00996346|E1|Reported Event|Irinotecan&Temsirolimus:Arm 1, Level 1|"Arm 1, Level 1: Irinotecan intravenously at 80 mg/m2 + Temsirolimus intravenously at 15 mg on a weekly basis for 3 consecutive doses followed by one week of rest.~One cycle is four weeks."
933976|NCT00996333|B1|Baseline|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
933977|NCT00996333|P1|Participant Flow|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
933978|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
933979|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
933980|NCT00996333|O1|Outcome|Gemzar, Taxotere, Xeloda|"Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
933981|NCT00996333|E1|Reported Event|Gemzar, Taxotere, Xeloda|"Gemcitabine, Docetaxel, Capecitabine:~Gemzar intravenously on Day 4 and 11 Taxotere intravenously on Day 4 and 11 Xeloda tablet taken orally every day for 14 days~Gemcitabine, Docetaxel, Capecitabine: 1500mg/m2/day of Capecitabine for 14 days 750mg/m2 of Gemcitabine on Day 4 and 11 30mg/m2 of Docetaxel on Day 4 and 11~This 2-week regimen is followed by 1 week off for a total of a 21-day cycle. This is repeated for a total of 3 cycles."
933982|NCT00996307|B5|Baseline|Total|Total of all reporting groups
933983|NCT00996307|B4|Baseline|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933984|NCT00996307|B3|Baseline|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933985|NCT00996307|B2|Baseline|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933986|NCT00996307|B1|Baseline|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933987|NCT00996307|P4|Participant Flow|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933988|NCT00996307|P3|Participant Flow|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933989|NCT00996307|P2|Participant Flow|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933990|NCT00996307|P1|Participant Flow|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933991|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933992|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933993|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933994|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933995|NCT00996307|O8|Outcome|15_(0)MF59 - Baseline HI ≥1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933996|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933997|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
933998|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
933999|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934000|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934004|NCT00996307|O7|Outcome|7.5_(50)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934005|NCT00996307|O6|Outcome|7.5_(0)MF59 - Baseline HI ≥1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934006|NCT00996307|O5|Outcome|3.75_(50)MF59 - Baseline HI ≥1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934007|NCT00996307|O4|Outcome|15_(0)MF59 - HI <1:10|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934008|NCT00996307|O3|Outcome|7.5_(50)MF59 - HI <1:10|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934009|NCT00996307|O2|Outcome|7.5_(0)MF59 - HI <1:10|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934010|NCT00996307|O1|Outcome|3.75_(50)MF59- Baseline HI <1:10|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934011|NCT00996307|O8|Outcome|15_(0)MF59-with Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934012|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934013|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934014|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934015|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934016|NCT00996307|O3|Outcome|7.5_(50)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934017|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934018|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934019|NCT00996307|O8|Outcome|15_(0)MF59-Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934020|NCT00996307|O7|Outcome|7.5_(50) MF59-Previous Vaccinaiton|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934021|NCT00996307|O6|Outcome|7.5_(0)MF59-Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934022|NCT00996307|O5|Outcome|3.75_(50)MF59-Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934023|NCT00996307|O4|Outcome|15_(0)MF59 - No Previous Vaccination|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934024|NCT00996307|O3|Outcome|7.5_(50)MF59-No Previous Vaccination|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934025|NCT00996307|O2|Outcome|7.5_(0)MF59 - No Previous Vaccination|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934026|NCT00996307|O1|Outcome|3.75_(50)MF59- No Previous Vaccination|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934027|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934028|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934029|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934030|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934031|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934032|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934033|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934034|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934035|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934036|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934037|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934038|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934039|NCT00996307|O4|Outcome|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934040|NCT00996307|O3|Outcome|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934041|NCT00996307|O2|Outcome|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934042|NCT00996307|O1|Outcome|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934043|NCT00996307|E4|Reported Event|15_(0)MF59|15 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934044|NCT00996307|E3|Reported Event|7.5_(50)MF59|7.5 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934045|NCT00996307|E2|Reported Event|7.5_(0)MF59|7.5 µg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22.
934046|NCT00996307|E1|Reported Event|3.75_(50)MF59|3.75 µg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22.
934047|NCT00996281|B3|Baseline|Total|Total of all reporting groups
934076|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934077|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934078|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
936283|NCT00989950|O1|Outcome|9 hr Wear|Result for all patients when patch worn for 9 hrs/day
934048|NCT00996281|B2|Baseline|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934049|NCT00996281|B1|Baseline|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934050|NCT00996281|P2|Participant Flow|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934051|NCT00996281|P1|Participant Flow|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934052|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934053|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934054|NCT00996281|O2|Outcome|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934055|NCT00996281|O1|Outcome|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934253|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
934056|NCT00996281|E2|Reported Event|Olmesartan Medoxomil and Hydrochlorothiazide|Participants in the United States: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 40 mg and hydrochlorothiazide 25 mg. Participants in Europe: Olmesartan medoxomil 20 mg and hydrochlorothiazide 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of Olmesartan medoxomil 20 mg and hydrochlorothiazide 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934057|NCT00996281|E1|Reported Event|Azilsartan Medoxomil and Chlorthalidone|Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily for up to 52 weeks. For participants who did not achieve target blood pressure by Week 4, titration to a maximum dose of azilsartan medoxomil 80 mg and chlorthalidone 25 mg. Additional antihypertensive agents could be added as needed to achieve blood pressure control.
934058|NCT00996216|B1|Baseline|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934079|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934080|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934171|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934059|NCT00996216|P1|Participant Flow|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934060|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934061|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934062|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934108|NCT00996125|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934109|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934110|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934421|NCT00995345|O3|Outcome|Dose 2: KRP-104|80 mg QD
934063|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934064|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934065|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934081|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934082|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934083|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934066|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934067|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934068|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934069|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934070|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934071|NCT00996216|O1|Outcome|Eltrombopag|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study. Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934072|NCT00996216|E2|Reported Event|Eltrombopag (Part 2)|Once the desired platelet counts were reached in Part 1 (>=90 Gi/L or >=100 Gi/L), par. continued to receive the dose of eltrombopag from Part 1 and polyethylene glycol (Peg) interferon (INF) alfa-2a (>=90 Gi/L) or Peg IFN alfa-2b (>=100 Gi/L) plus ribavirin. Dose adjustments of eltrombopag were permitted to achieve and maintain an appropriate platelet count.
934073|NCT00996216|E1|Reported Event|Eltrombopag (Part 1)|In the Pre-antiviral Treatment Phase, participants (par.) with a platelet count of <75000/microliter (µL) received eltrombopag once daily for a minimum of 2 weeks and a maximum of 9 weeks in sequential dose escalations (25 milligrams [mg] for a minimum of 2 weeks, 50 mg for 1-2 weeks, 75 mg for 1-2 weeks, and 100 mg for 1-3 weeks) until platelet counts reached either >=90000/µL or 100000/µL. Par. who achieved the desired platelet count continued with eltrombopag in Part 2 along with antiviral treatment. Par. who did not achieve the desired platelet count completed the follow-up visits and were withdrawn from the study.
934074|NCT00996203|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934075|NCT00996203|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (but not more than 800 mg), intravenously (IV), every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934084|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934085|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934086|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934087|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934088|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934089|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934090|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934091|NCT00996203|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934092|NCT00996203|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (but not more than 800 mg), IV, every 4 weeks for 24 weeks. Participants received a total of 6 infusions.
934093|NCT00996164|B3|Baseline|Total|Total of all reporting groups
934094|NCT00996164|B2|Baseline|Placebo|placebo 1 tab po qd
934095|NCT00996164|B1|Baseline|Flibanserin 100 mg|flibanserin 100mg po qd
934096|NCT00996164|P2|Participant Flow|Placebo|placebo 1 tab po qd
934097|NCT00996164|P1|Participant Flow|Flibanserin 100 mg|flibanserin 100mg po qd
934098|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd~Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
934099|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd~Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
934100|NCT00996164|O2|Outcome|Placebo|"placebo 1 tab po qd~Placebo: patients will be randomized to flibanserin or placebo in a double-blind manner"
934101|NCT00996164|O1|Outcome|Flibanserin 100 mg|"flibanserin 100mg po qd~Flibanserin: patients will be randomized to flibanserin or placebo in a double-blind manner"
934102|NCT00996164|E2|Reported Event|Placebo|placebo 1 tab po qd
934103|NCT00996164|E1|Reported Event|Flibanserin 100 mg|flibanserin 100mg po qd
934104|NCT00996125|B3|Baseline|Total|Total of all reporting groups
934105|NCT00996125|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934106|NCT00996125|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934107|NCT00996125|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934111|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934112|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934113|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934114|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934115|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934116|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934117|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934118|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934119|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934120|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934121|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934122|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934123|NCT00996125|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934124|NCT00996125|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934125|NCT00996125|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo. Placebo vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934126|NCT00996125|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1, 6-month schedule.
934127|NCT00996034|B1|Baseline|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
934128|NCT00996034|P1|Participant Flow|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
934129|NCT00996034|O1|Outcome|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
934130|NCT00996034|E1|Reported Event|Healthy Smoker|"Healthy smokers with nicotine dependence~Nicotine bitartrate : 0.5-1.5 mg of Nicotine bitartrate, I.V. on each of two SPECT Scan days~[123I]5-IA-85380 : up to 10 mCi of [123I]5-IA-85380, I.V. on each of two SPECT Scan days~NicVAX : 1.0 mL of Nicotine Conjugate Vaccine(x4), I.M. at 3 week intervals between SPECT studies"
934131|NCT00995930|B3|Baseline|Total|Total of all reporting groups
934132|NCT00995930|B2|Baseline|ACZ885|150 mg SQ monthly
934133|NCT00995930|B1|Baseline|Placebo|SQ monthly
934134|NCT00995930|P2|Participant Flow|ACZ885|150 mg SQ monthly
934135|NCT00995930|P1|Participant Flow|Placebo|SQ monthly
934136|NCT00995930|O1|Outcome|ACZ885|150 mg SQ monthly
934137|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934138|NCT00995930|O1|Outcome|Placebo|SQ monthly
934139|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934140|NCT00995930|O1|Outcome|Placebo|SQ monthly
934141|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934142|NCT00995930|O1|Outcome|Placebo|SQ monthly
934143|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934144|NCT00995930|O1|Outcome|Placebo|SQ monthly
934145|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934146|NCT00995930|O1|Outcome|Placebo|SQ monthly
934147|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934148|NCT00995930|O1|Outcome|Placebo|SQ monthly
934149|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934150|NCT00995930|O1|Outcome|Placebo|SQ monthly
934151|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934152|NCT00995930|O1|Outcome|Placebo|SQ monthly
934153|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934154|NCT00995930|O1|Outcome|Placebo|SQ monthly
934155|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934156|NCT00995930|O1|Outcome|Placebo|SQ monthly
934157|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934158|NCT00995930|O1|Outcome|Placebo|SQ monthly
934159|NCT00995930|O2|Outcome|ACZ885|150 mg SQ monthly
934160|NCT00995930|O1|Outcome|Placebo|SQ monthly
934164|NCT00995904|P6|Participant Flow|Treatment C, Then Treatment B, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
934165|NCT00995904|P5|Participant Flow|Treatment C, Then Treatment A, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
934166|NCT00995904|P4|Participant Flow|Treatment B, Then Treatment C, Then Treatment A|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
934167|NCT00995904|P3|Participant Flow|Treatment B, Then Treatment A, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
934168|NCT00995904|P2|Participant Flow|Treatment A, Then Treatment C, Then Treatment B|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
934169|NCT00995904|P1|Participant Flow|Treatment A, Then Treatment B, Then Treatment C|Study visits were separated by 3-7 day intervals. Treatment A: 84ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 2; Treatment B: 42ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 3; Treatment C: 21ug MAP0020 (unit dose budesonide delivered by Aeroneb® Go) at Visit 4
934170|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934172|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934173|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934174|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934175|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934176|NCT00995904|O3|Outcome|84ug MAP0020|84ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
934177|NCT00995904|O2|Outcome|42ug MAP0020|42ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
934178|NCT00995904|O1|Outcome|21ug MAP0020|21ug of unit dose budesonide delivered by Aeroneb® Go (MAP0020) as per protocol
934179|NCT00995904|E3|Reported Event|84ug MAP0020|84ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934180|NCT00995904|E2|Reported Event|42ug MAP0020|42ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934181|NCT00995904|E1|Reported Event|21ug MAP0020|21ug of unit dose budesonide inhalation suspension delivered by Aeroneb® Go (MAP0020) as per protocol
934182|NCT00995865|B4|Baseline|Total|Total of all reporting groups
934183|NCT00995865|B3|Baseline|Placebo Group|This third group of 12 subjects were to receive a placebo (0.9% normal saline for injection).
934184|NCT00995865|B2|Baseline|Mid-Dose Group|Two groups of 24 subjects each were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for this (mid dose) group.
934185|NCT00995865|B1|Baseline|High Dose Group|Two groups of 24 subjects each, (one arm called a high dose group, the other a Mid-Dose group) were to receive two intramuscular (IM) injections (0.5mL) of XRX-001 vaccine containing either greater than or equal to 8.0 log10 VE/dose (viral equivalent) (high dose) or 1/10th of the high dose for the (mid dose).
934186|NCT00995865|P3|Participant Flow|Placebo|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
934187|NCT00995865|P2|Participant Flow|Mid Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934188|NCT00995865|P1|Participant Flow|High Dose|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934189|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.~12 Subjects were examined in this group."
934190|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934191|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~24 Subjects were examined in this group."
934192|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
934193|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934194|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934195|NCT00995865|O3|Outcome|Placebo Group|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9%"
934196|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934197|NCT00995865|O1|Outcome|High Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934198|NCT00995865|O3|Outcome|Placebo Group|"Subjects were administered with NaCl Injectable 0.9%.~12 Subjects were examined in this group."
934422|NCT00995345|O2|Outcome|Dose 1: KRP-104|40 mg QD
934199|NCT00995865|O2|Outcome|Mid Dose Group|XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL
934200|NCT00995865|O1|Outcome|High Dose Group|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~24 Subjects were examined in this group."
934201|NCT00995865|E6|Reported Event|Placebo Second Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% Second injection."
934202|NCT00995865|E5|Reported Event|Mid Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection."
934203|NCT00995865|E4|Reported Event|High Dose Second Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~Second injection at an interval of 21 days"
934204|NCT00995865|E3|Reported Event|Placebo First Injection|"NaCl Injectable 0.9%~Placebo: NaCl Injectable 0.9% First injection."
934205|NCT00995865|E2|Reported Event|Mid Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
934206|NCT00995865|E1|Reported Event|High Dose First Injection|"XRX-001 Inactivated yellow fever vaccine: Inactivated yellow fever vaccine, alum adsorbed, High dose = 2.3 x 10^8 VE/0.5mL and Mid dose = 2.2 x 10^7 VE/0.5mL.~First injection."
934207|NCT00995774|B3|Baseline|Total|Total of all reporting groups
934208|NCT00995774|B2|Baseline|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
934209|NCT00995774|B1|Baseline|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
934210|NCT00995774|P2|Participant Flow|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
951280|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
934211|NCT00995774|P1|Participant Flow|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
934212|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
934213|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
934214|NCT00995774|O2|Outcome|Conventional Then Robotic|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
934215|NCT00995774|O1|Outcome|Robotic Then Conventional|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
934216|NCT00995774|E2|Reported Event|Arm 2|12 hours of conventional arm therapy with a physical therapist, followed by a 1 month washout period, followed by 12 hours of robotic arm therapy
934217|NCT00995774|E1|Reported Event|Arm 1|12 hours of robotic arm therapy, followed by a 1 month washout period, followed by 12 hours of conventional arm therapy with a physical therapist
934218|NCT00995761|B1|Baseline|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
934219|NCT00995761|P1|Participant Flow|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
934220|NCT00995761|O1|Outcome|Biweekly Schedule of Docetaxel and Cisplatin|we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC.
934221|NCT00995761|E1|Reported Event|Biweekly Schedule|docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks
934222|NCT00995722|B3|Baseline|Total|Total of all reporting groups
934223|NCT00995722|B2|Baseline|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934224|NCT00995722|B1|Baseline|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934225|NCT00995722|P2|Participant Flow|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934226|NCT00995722|P1|Participant Flow|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934227|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934254|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934255|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934423|NCT00995345|O1|Outcome|Placebo|Tablet
934228|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934229|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934230|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934231|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934232|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934233|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934383|NCT00995371|B2|Baseline|Epidural Steroid Injection|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
951281|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
934234|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934235|NCT00995722|O2|Outcome|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934236|NCT00995722|O1|Outcome|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934237|NCT00995722|E2|Reported Event|Placebo|"Matched, inactive substance~Placebo: Placebo dosages will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain matching placebo.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934238|NCT00995722|E1|Reported Event|Prednisone|"Corticosteroid~Prednisone: Prednisone will be adjusted based on combined measures of tolerability and efficacy. Capsules will contain 10mg of prednisone.~Pyridostigmine: Prior to randomization, pyridostigmine dosage increments will be made as needed for myasthenic symptoms and as tolerated according to a pre-specified dosage titration schedule. Following randomization, dose will remain constant."
934239|NCT00995709|B4|Baseline|Total|Total of all reporting groups
934240|NCT00995709|B3|Baseline|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934241|NCT00995709|B2|Baseline|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
934242|NCT00995709|B1|Baseline|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934243|NCT00995709|P3|Participant Flow|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934244|NCT00995709|P2|Participant Flow|AIN457C 300 mg Monthly Dosage Regimen|"AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.~One patient in the AIN457 300 mg monthly group (PID 0161/00002) was randomized; however, this patient did not meet eligibility criteria and never received study medication"
934245|NCT00995709|P1|Participant Flow|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934246|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934247|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
934248|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934249|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934250|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
934251|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934252|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934424|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
934256|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
934257|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934258|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934259|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
934260|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934261|NCT00995709|O3|Outcome|Placebo to AIN457C|Placebo was administered in 2 s.c. injections
934262|NCT00995709|O2|Outcome|AIN457C 300 mg Monthly Dosage Regimen (a)|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each
934263|NCT00995709|O1|Outcome|AIN457C 300 mg Every 2 Week Dosage Regimen|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934264|NCT00995709|E3|Reported Event|Placebo|Placebo was administered in 2 s.c. injections
934265|NCT00995709|E2|Reported Event|AIN457 300mg Monthly|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934266|NCT00995709|E1|Reported Event|AIN457 300mg Every 2 Weeks|AIN457 300 mg was administered in 2 subcutaneous (s.c.) injections of 150 mg each.
934267|NCT00995670|B4|Baseline|Total|Total of all reporting groups
934268|NCT00995670|B3|Baseline|Statin and Glucose|"Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Statin: 40 mg of simvastatin 17 volunteers were studied 31 times in this arm."
934596|NCT00994461|E2|Reported Event|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934269|NCT00995670|B2|Baseline|Vitamin C and Glucose|"To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Placebo data were the placebo studies from the Sevoflurane and Glucose arm, when appropriate; new subjects (not enrolled in Sevoflurane and Glucose arm) underwent a separate placebo trial.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min.~Vitamin C: 1 gm iv bolus injection 5 min before I/R injury 16 volunteers were studied 25 times in this arm."
934270|NCT00995670|B1|Baseline|Sevoflurane and Glucose|"Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.~Glucose: 5% dextrose will be infused at 12ml/hr to a target of 200 mg/dl blood concentration in the experimental forearm for 60 min to prevent the anesthetic preconditioning (sevoflurane) protection against subsequent I/R injury.~Sevoflurane: 1 minimum alveolar concentration (MAC) for 20 min (after hour of glucose and before I/R) 26 volunteers were studied 67 times in this arm."
934271|NCT00995670|P3|Participant Flow|Statin and Glucose|Volunteers ingested a 40 mg simvastatin (statin) pill for the two evenings prior to study day and the morning of the study to determine the effect of simvastatin on modulating the I/R injury during hyperglycemia (high glucose). Volunteers were studied with statin alone and with statin and glucose.
934272|NCT00995670|P2|Participant Flow|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium (FBF) caused by the glucose (dextrose infusion). All subjects received glucose and I/R injury (ischemia), either with or without vitamin C. Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
934273|NCT00995670|P1|Participant Flow|Sevoflurane and Glucose|Endothelial function will be measured via forearm blood flow (FBF). Subjects may get I/R injury (ischemia) without glucose or sevoflurane (placebo trial); I/R with glucose only (glucose trial); I/R with sevoflurane only (sevoflurane trial); I/R with glucose and sevoflurane (combined trial). Control baseline FBF was taken in every trial before any intervention, and FBF was taken during intervention and post I/R.
934274|NCT00995670|O3|Outcome|Statin and Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
934275|NCT00995670|O2|Outcome|Vitamin C and Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
934276|NCT00995670|O1|Outcome|Sevoflurane and Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
934277|NCT00995670|E3|Reported Event|Statins & Glucose|To determine the effect of simvastatin on modulating the I/R injury during the normal glucose state and during hyperglycemia.
934278|NCT00995670|E2|Reported Event|Vitamin C & Glucose|To determine if vitamin C can restore the impairment of the endothelium caused by the dextrose infusion.
934279|NCT00995670|E1|Reported Event|Sevoflurane & Glucose|To determine the effectiveness of anesthetic preconditioning (APC) via sevoflurane to attenuate the I/R injury during the normal glucose state and during hyperglycemia.
934280|NCT00995566|B1|Baseline|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934281|NCT00995566|P1|Participant Flow|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934282|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934283|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934284|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934285|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934286|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934287|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934288|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934289|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934290|NCT00995566|O1|Outcome|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934291|NCT00995566|E1|Reported Event|Thelin Registry Patients|The use and dosage recommendations for Thelin (sitaxentan sodium) was in accordance with the local summary of Product Characteristics.
934292|NCT00995553|B3|Baseline|Total|Total of all reporting groups
934293|NCT00995553|B2|Baseline|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
934294|NCT00995553|B1|Baseline|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
934295|NCT00995553|P2|Participant Flow|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
934296|NCT00995553|P1|Participant Flow|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
934297|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
934298|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
934299|NCT00995553|O2|Outcome|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
934300|NCT00995553|O1|Outcome|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
934301|NCT00995553|E2|Reported Event|Computer Skills|"This is a 48-session, time matched comparison group in which participants practice keyboarding skills and the fundamentals of Microsoft Office Word, Powerpoint, and Excel programs.~Computer Skills: This is a computer-based course in which participants will be taught how to use Microsoft Office applications and typing skills. Participants will attend a 1-hour course three times a week four 4-months."
934302|NCT00995553|E1|Reported Event|Cognitive Remediation|"A 48-session working memory focused cognitive remediation program is conducted. Training tasks have been selected from 3 software programs, PSS CogRehab, BrainTrain, and custom made N-back tasks.~Cognitive Remediation: This is an adaptive, computer-based cognitive training intervention. Participants will complete 3 1-hour cognitive training sessions focused on attention and working memory processes weekly for 4 months."
934303|NCT00995501|B9|Baseline|Total|Total of all reporting groups
934304|NCT00995501|B8|Baseline|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934367|NCT00995436|B1|Baseline|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
934368|NCT00995436|P3|Participant Flow|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
934305|NCT00995501|B7|Baseline|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934306|NCT00995501|B6|Baseline|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934307|NCT00995501|B5|Baseline|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934308|NCT00995501|B4|Baseline|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
934384|NCT00995371|B1|Baseline|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
934597|NCT00994461|E1|Reported Event|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934309|NCT00995501|B3|Baseline|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934310|NCT00995501|B2|Baseline|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934311|NCT00995501|B1|Baseline|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
934312|NCT00995501|P8|Participant Flow|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934313|NCT00995501|P7|Participant Flow|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934314|NCT00995501|P6|Participant Flow|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934369|NCT00995436|P2|Participant Flow|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
934370|NCT00995436|P1|Participant Flow|Headgear|"Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage : Extra oral anchorage using headgear"
934371|NCT00995436|O3|Outcome|Headgear|
934315|NCT00995501|P5|Participant Flow|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934316|NCT00995501|P4|Participant Flow|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
934317|NCT00995501|P3|Participant Flow|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934318|NCT00995501|P2|Participant Flow|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934319|NCT00995501|P1|Participant Flow|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
934598|NCT00994448|B3|Baseline|Total|Total of all reporting groups
934599|NCT00994448|B2|Baseline|Placebo (Sugar Pill)|Matching placebo tablets twice a day
934320|NCT00995501|O8|Outcome|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934321|NCT00995501|O7|Outcome|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934322|NCT00995501|O6|Outcome|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934323|NCT00995501|O5|Outcome|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934324|NCT00995501|O4|Outcome|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
934325|NCT00995501|O3|Outcome|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934326|NCT00995501|O2|Outcome|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934327|NCT00995501|O1|Outcome|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
934328|NCT00995501|O8|Outcome|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934329|NCT00995501|O7|Outcome|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934330|NCT00995501|O6|Outcome|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934600|NCT00994448|B1|Baseline|Bupropion|Bupropion SR 150 mg twice a day
934601|NCT00994448|P2|Participant Flow|Placebo (Sugar Pill)|Matching placebo tablets twice a day
934331|NCT00995501|O5|Outcome|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934332|NCT00995501|O4|Outcome|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
934333|NCT00995501|O3|Outcome|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934334|NCT00995501|O2|Outcome|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934335|NCT00995501|O1|Outcome|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
934336|NCT00995501|E8|Reported Event|Conventional Glucose Control, Placebo, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934337|NCT00995501|E7|Reported Event|Conventional Glucose Control, Placebo, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934338|NCT00995501|E6|Reported Event|Conventional Glucose Control, Dexamethasone, Deep Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934339|NCT00995501|E5|Reported Event|Intensive Glucose Control, Placebo, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934340|NCT00995501|E4|Reported Event|Conventional Glucose Control, Dexamethasone, Light Anesthesia|"Conventional Glucose Control The target range for blood glucose will be 180-200 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55~Dexamethasone - placebo: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning"
934341|NCT00995501|E3|Reported Event|Intensive Glucose Control, Placebo, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Placebo Placebo administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~anesthesia management: Light anesthesia to maintain BIS about 55~Insulin - Placebo: Insulin to maintain blood glucose 180-200 mg/dl."
934602|NCT00994448|P1|Participant Flow|Bupropion|Bupropion SR 150 mg twice a day
934603|NCT00994448|O2|Outcome|Placebo (Sugar Pill)|Matching placebo tablets twice a day
934342|NCT00995501|E2|Reported Event|Intensive Glucose Control, Dexamethasone, Deep Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Deep anesthesia target BIS of 35~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~Anesthesia management -Placebo: Deep anesthesia to maintain BIS about 35"
934343|NCT00995501|E1|Reported Event|Intensive Glucose Control, Dexamethasone, Light Anesthesia|"Intensive Glucose Control The target range for blood glucose will be 80-110 mg/dl~Dexamethasone Dexamethasone administered at 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning.~Light anesthesia target BIS of 55~Dexamethasone Sodium Sulfate: 8 mg given 1-2 hours before surgery (incision time), 4 mg on the first postoperative morning, and 2 mg on the second postoperative morning~Insulin: Insulin to maintain blood glucose 80-110 mg/dl.~anesthesia management: Light anesthesia to maintain BIS about 55"
934344|NCT00995488|B1|Baseline|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
934345|NCT00995488|P1|Participant Flow|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
934346|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
934347|NCT00995488|O1|Outcome|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
934348|NCT00995488|E1|Reported Event|ABI-007|ABI-007 combined with Carboplatin, and Gemcitabine
934349|NCT00995449|B5|Baseline|Total|Total of all reporting groups
934350|NCT00995449|B4|Baseline|Placebo|Placebo comparator
934351|NCT00995449|B3|Baseline|KB003 600 mg|600 mg, KB003 a monoclonal antibody
934352|NCT00995449|B2|Baseline|KB003 200 mg|Dose group not evaluated in this portion of study
934353|NCT00995449|B1|Baseline|KB003 70mg|Dose group not evaluated in this portion of study
934354|NCT00995449|P4|Participant Flow|Placebo|Placebo comparator
934355|NCT00995449|P3|Participant Flow|KB003 600 mg|600 mg, KB003 a monoclonal antibody
934356|NCT00995449|P2|Participant Flow|KB003 200 mg|Dose group not evaluated in this portion of study
934357|NCT00995449|P1|Participant Flow|KB003 70mg|Dose group not evaluated in this portion of study
934358|NCT00995449|O2|Outcome|Placebo|Placebo comparator
934359|NCT00995449|O1|Outcome|KB003 600 mg|600 mg, KB003 a monoclonal antibody
934360|NCT00995449|E4|Reported Event|Placebo|Placebo comparator
934361|NCT00995449|E3|Reported Event|KB003 600 mg|600 mg, KB003 a monoclonal antibody
934362|NCT00995449|E2|Reported Event|KB003 200 mg|Dose group not evaluated in this portion of study
934363|NCT00995449|E1|Reported Event|KB003 70mg|Dose group not evaluated in this portion of study
934364|NCT00995436|B4|Baseline|Total|Total of all reporting groups
934365|NCT00995436|B3|Baseline|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage : Intraoral dental anchorage by using Nance palatal arch on molars"
934366|NCT00995436|B2|Baseline|Miniscrews|"Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device : Intraoral skeletal anchorage using mini screws"
934372|NCT00995436|O2|Outcome|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
934373|NCT00995436|O1|Outcome|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
934374|NCT00995436|E3|Reported Event|Nance Palatal Arch|"Anchorage supplemented by fixing molars together with an arch~Intraoral dental anchorage: Intraoral dental anchorage by using Nance palatal arch on molars"
934375|NCT00995436|E2|Reported Event|Miniscrews|"Device Placement of micro-screw to supplement anchorage~Intraoral skeletal anchorage - Temporary anchorage device: Intraoral skeletal anchorage using mini screws"
934376|NCT00995436|E1|Reported Event|Headgear|"Device Placement of extraoral traction to be worn 100 hours per week~Extraoral anchorage: Extra oral anchorage"
934377|NCT00995410|B1|Baseline|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
934378|NCT00995410|P1|Participant Flow|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
934379|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
934380|NCT00995410|O1|Outcome|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
934381|NCT00995410|E1|Reported Event|PA32540 Tablet|"325 mg enteric coated (EC) ASA and 40 mg omeprazole to be taken by mouth once daily~PA32540: PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole to be taken by mouth once daily (QD)"
934382|NCT00995371|B3|Baseline|Total|Total of all reporting groups
934604|NCT00994448|O1|Outcome|Bupropion|Bupropion SR 150 mg twice a day
934385|NCT00995371|P2|Participant Flow|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, when unblinded, were given option to cross-over to and receive the mild procedure using the mild device kit
934386|NCT00995371|P1|Participant Flow|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
934387|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
934388|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
934389|NCT00995371|O2|Outcome|Epidural Steroid Injection Then Lumbar Decompression With Mild|Group 2: After post-treatment Week 6 and prior to 4 months patients in ESI procedure arm, after unblinding, were given option to cross-over to and receive the mild procedure using the mild device kit.
934390|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
934391|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
934392|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
934393|NCT00995371|O2|Outcome|Epidural Steroid Injection Prior to Cross-Over|Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.
934394|NCT00995371|O1|Outcome|Vertos Mild® Minimally-Invasive Lumbar Decompression (Mild)|Group 1: Patients in the Vertos mild treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
934395|NCT00995371|E3|Reported Event|ESI Cross-over to Lumbar Decompression With Mild|Group 3: Patients in the Epidural Steroid Injection (ESI) group treated by the physicians in accordance with product labeling and indications for use, crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure
934396|NCT00995371|E2|Reported Event|Epidural Steroid Injection|"Group 2: Patients in the Epidural Steroid Injection (ESI) group will be treated by the physicians in accordance with product labeling and indications for use.~The ESI group analyzed crossed over to receive the mild procedure after being unblinded. The results are up to 26 weeks post-mild procedure"
934397|NCT00995371|E1|Reported Event|Vertos Mild® Minimally-Invasive Lumbar Decompression|Group 1: Patients in the Vertos mild® treatment group will be treated by appropriately trained physicians in accordance with the product labeling and indications for use.
934398|NCT00995345|B6|Baseline|Total|Total of all reporting groups
934399|NCT00995345|B5|Baseline|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
934400|NCT00995345|B4|Baseline|Dose 3: KRP-104|100 mg QD
934401|NCT00995345|B3|Baseline|Dose 2: KRP-104|80 mg QD
934402|NCT00995345|B2|Baseline|Dose 1: KRP-104|40 mg QD
934403|NCT00995345|B1|Baseline|Placebo|Tablet
934404|NCT00995345|P5|Participant Flow|Dose 4: KRP-104|20 mg /120 mg QD (dose switch at week12)
934405|NCT00995345|P4|Participant Flow|Dose 3: KRP-104|100 mg QD
934406|NCT00995345|P3|Participant Flow|Dose 2: KRP-104|80 mg QD
934407|NCT00995345|P2|Participant Flow|Dose 1: KRP-104|40 mg QD
934408|NCT00995345|P1|Participant Flow|Placebo|Tablet
934409|NCT00995345|O5|Outcome|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
934429|NCT00995345|E5|Reported Event|Dose 4: KRP-104|20 mg QD (weeks 1-12)/120 mg QD (weeks 12-24)
934430|NCT00995345|E4|Reported Event|Dose 3: KRP-104|100 mg QD
934431|NCT00995345|E3|Reported Event|Dose 2: KRP-104|80 mg QD
934432|NCT00995345|E2|Reported Event|Dose 1: KRP-104|40 mg QD
934433|NCT00995345|E1|Reported Event|Placebo|Tablet
934434|NCT00995085|B1|Baseline|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
934435|NCT00995085|P1|Participant Flow|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
934436|NCT00995085|O1|Outcome|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
934437|NCT00995085|E1|Reported Event|Metadoxine SR|Metadoxine is a pyrolate salt of Pyridoxine
934438|NCT00995020|B3|Baseline|Total|Total of all reporting groups
934605|NCT00994448|E2|Reported Event|Placebo (Sugar Pill)|Matching placebo tablets twice a day
934439|NCT00995020|B2|Baseline|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
934440|NCT00995020|B1|Baseline|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
934441|NCT00995020|P2|Participant Flow|LLETZ Cone: Large Loop Excision of Transformation Zone - Cone|The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium.
934442|NCT00995020|P1|Participant Flow|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ (straight wire excision of the transformation zone), which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
934443|NCT00995020|O2|Outcome|SWETZ|SWETZ uses a 1cm straight 0.20mm wire to fashion a similar excision.
934444|NCT00995020|O1|Outcome|LLETZ - Cone|LLETZ - cone was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
934445|NCT00995020|O2|Outcome|LLETZ Cone|LLETZ cone,the standard procedure is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
934446|NCT00995020|O1|Outcome|SWETZ|SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
934447|NCT00995020|E2|Reported Event|LLETZ Cone - Loop Excision of TZ Cone Biopsy|The standard procedure, LLETZ - cone, was performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
934448|NCT00995020|E1|Reported Event|SWETZ - Straight Wire Excision of the Transformation Zone|The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
934449|NCT00995007|B3|Baseline|Total|Total of all reporting groups
934450|NCT00995007|B2|Baseline|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934451|NCT00995007|B1|Baseline|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
934452|NCT00995007|P2|Participant Flow|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934453|NCT00995007|P1|Participant Flow|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
934563|NCT00994604|O1|Outcome|Airway Size Pre BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
934454|NCT00995007|O3|Outcome|Cross Over to Vandetanib|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934517|NCT00994682|P1|Participant Flow|Placebo|After all participants receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on placebo (or pioglitazone) in a randomized, double-blind,placebo-controlled study design by the research pharmacy. Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
934606|NCT00994448|E1|Reported Event|Bupropion|Bupropion SR 150 mg twice a day
934455|NCT00995007|O2|Outcome|Vandetanib With Carboplatin|"Sequential Group (carboplatin followed by vandetanib)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934456|NCT00995007|O1|Outcome|Carboplatin|"Combo Group (both drugs together)~ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934457|NCT00995007|O4|Outcome|Anaplastic Astrocytoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
934458|NCT00995007|O3|Outcome|Anaplastic Astrocytoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934459|NCT00995007|O2|Outcome|Glioblastoma (Carboplation Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
934460|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934461|NCT00995007|O4|Outcome|Anaplastic Astrocytomas (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
934462|NCT00995007|O3|Outcome|Anaplastic Astrocytomas (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934463|NCT00995007|O2|Outcome|Glioblastoma (Carboplatin Alone)|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
934464|NCT00995007|O1|Outcome|Glioblastoma (Combination)|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934465|NCT00995007|E3|Reported Event|Crossover to Vandetanib|ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
934685|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
934466|NCT00995007|E2|Reported Event|Vandetanib With Carboplatin|"ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.~Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy."
934467|NCT00995007|E1|Reported Event|Carboplatin|Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
934576|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934577|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
934607|NCT00994422|B3|Baseline|Total|Total of all reporting groups
934468|NCT00994929|B1|Baseline|Neumega (Oprelveken, Interleukin 11)|The VWD subjects included two with type 1 VWD and two with type 2 VWD, including one with type 2B, with increased platelet aggregation at low strength ristocetin and absent high molecular weight multimers, and one with type 2M disease, with reduced VWF:RCoF/ VWF:Ag ratio <0.50, per NHLBI criteria (Table 2).5 All subjects had positive past bleeding histories. Pregnancy, lactation, heart disease, uncontrolled hypertension, arrhythmia, thrombosis, recent surgery or receipt of blood products were exclusions. A total of nine subjects were enrolled and completed study, including five with hemophilia A and four with VWD. The median age was 26 years, range 22-51 years
934469|NCT00994929|P1|Participant Flow|Neumega (Oprelveken, Interleukin 11)|25 µg/kilogram of body weight of rhIL-11 subcutaneously administered on days 1 to 4. On day 4 following rhIL-11 injection DDAVP was subsequently given at 0.3 mcg/kg intravenously over 30 minutes. For any subject with past allergic reactions, hypersensitivity, or seizures with DDAVP, or in whom DDAVP is contraindicated, DDAVP was not given: only rhIL-11 was given on Day 4.
934470|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
934471|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|"Neumega (Oprelveken, interleukin-11 (IL-11) 25 microgram/kilogram by subcutaneou injection once daily for four days, followed on day 4 DDAVP 0.3 microgram/kilogram intravenously 30 minutes after neumega~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11."
934472|NCT00994929|O1|Outcome|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed by DDAVP 0.3 microgram/kg by intravenous infusion over 30 minutes on day 4, 30 minutes after IL-11.
934473|NCT00994929|E1|Reported Event|Neumega (Oprelveken, Interleukin 11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 microgram/kg IL-11 by subcutaneous injection once daily for four days, followed on day 4 by DDAVP 0.3 microgram/kg by intravenous infusion.
934474|NCT00994760|B1|Baseline|GENISIS|Intranasal Fentanyl Spray
934475|NCT00994760|P1|Participant Flow|GENISIS|Intranasal Fentanyl Spray
934476|NCT00994760|O1|Outcome|Caregiver at Final Visit|
934477|NCT00994760|O1|Outcome|Caregiver at Final Visit|
934478|NCT00994760|O1|Outcome|Caregiver at Final Visit|
934479|NCT00994760|O1|Outcome|Caregiver at Final Visit|
934480|NCT00994760|O1|Outcome|Patients at Final Visit|
934481|NCT00994760|O1|Outcome|Patients at Final Visit|
934482|NCT00994760|O2|Outcome|Last Visit (LV)|
934483|NCT00994760|O1|Outcome|First Visit (FV)(Patients With Previous BTP-medication Only)|
934484|NCT00994760|O1|Outcome|Patients at Final Visit|
934485|NCT00994760|O2|Outcome|Last Visit|
934486|NCT00994760|O1|Outcome|Initial Visit|
934487|NCT00994760|O2|Outcome|Last Visit|
934488|NCT00994760|O1|Outcome|Initial Visit|
934489|NCT00994760|O2|Outcome|Last Visit|
934490|NCT00994760|O1|Outcome|Initial Visit|
934491|NCT00994760|O2|Outcome|Last Visit|
934492|NCT00994760|O1|Outcome|Initial Visit|
934493|NCT00994760|O2|Outcome|Last Visit|
934494|NCT00994760|O1|Outcome|Initial Visit|
934495|NCT00994760|O2|Outcome|Last Visit|
934496|NCT00994760|O1|Outcome|Initial Visit|
934497|NCT00994760|O2|Outcome|Last Visit|
934498|NCT00994760|O1|Outcome|Initial Visit|
934499|NCT00994760|O1|Outcome|Patients at First Visit|
934500|NCT00994760|O1|Outcome|First Visit|
934501|NCT00994760|O2|Outcome|Last Visit (LV)|
934502|NCT00994760|O1|Outcome|Initial Visit (IV)|
934503|NCT00994760|O1|Outcome|GENISIS|Intranasal Fentanyl Spray
934504|NCT00994760|O1|Outcome|Physician Last Visit (LV)|
934505|NCT00994760|O2|Outcome|Last Visit (LV)|
934506|NCT00994760|O1|Outcome|First Visit (FV): Patients With Previous BTP- Medication Only|
934507|NCT00994760|O1|Outcome|Last Visit|
934508|NCT00994760|O2|Outcome|Last Visit|
934509|NCT00994760|O1|Outcome|Initial Visit|
934510|NCT00994760|O2|Outcome|Study End|
934511|NCT00994760|O1|Outcome|Study Start|
934512|NCT00994760|E1|Reported Event|All Patients Treated|
934513|NCT00994682|B3|Baseline|Total|Total of all reporting groups
934556|NCT00994682|E4|Reported Event|Pioglitazone (Months 18-36)|After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
951410|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
934514|NCT00994682|B2|Baseline|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934515|NCT00994682|B1|Baseline|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934516|NCT00994682|P2|Participant Flow|Pioglitazone|After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or T2DM and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
934578|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934518|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934519|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934520|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934521|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934522|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934523|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934524|NCT00994682|O2|Outcome|Placebo|"After dietary counseling to all patients at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Placebo: An oral tablet identical to pioglitazone will be given once daily but without active drug for 18 months.~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934557|NCT00994682|E3|Reported Event|Placebo (PIO Open-label)|After being randomized to placebo for the first 18 months, patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934564|NCT00994604|O2|Outcome|Broccoli Sprout Extract - BD|pre- and post-consumption of broccoli sprout extract for 2 weeks
934525|NCT00994682|O1|Outcome|Pioglitazone|"After all patients receive dietary counseling at the research unit (CTSA), patients with prediabetes or type 2 diabetes mellitus (T2DM) and NASH will be started on pioglitazone (or placebo) in a randomized, double-blind,placebo-controlled study design. Pioglitazone will be given at 30 mg/day for the first 2 months and titrated to 45 mg/day thereafter (if well tolerated).~Pioglitazone study drug: 30 mg per day orally for 8 weeks, and if well tolerated, titrated to 45 mg per day until the end of 18 months~Pioglitazone Open Label: Patients in both arms were placed open label pioglitazone for an additional 18 months after successfully completing the double-blind, placebo-controlled portion of the study design."
934526|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934527|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934579|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934580|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
934581|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934582|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934528|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934529|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934530|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934531|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934532|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934533|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934534|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934558|NCT00994682|E2|Reported Event|Pioglitazone (First 18 Months)|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d).
934559|NCT00994682|E1|Reported Event|Placebo (First 18 Months)|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills.
934535|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934536|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934537|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934538|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934583|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
934584|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934585|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934586|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
934539|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934540|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934541|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934542|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934543|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934544|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934560|NCT00994604|B1|Baseline|Broccoli Sprout Extract|broccoli sprout extract: consumption of broccoli sprout extract for 2 weeks
934561|NCT00994604|P1|Participant Flow|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
934562|NCT00994604|O2|Outcome|Airway Size Post BSE|CT scan measurements of changes in luminal area with BSE treatment measured at either total lung capacity (TLC) or functional residual capacity (FRC) (mean ± SD).
934545|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934546|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934547|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934548|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934549|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934587|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934588|NCT00994461|O1|Outcome|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934550|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934551|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934552|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934553|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934554|NCT00994682|O2|Outcome|Pioglitazone|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received pioglitazone 30mg/d (titrated after 2 months to 45 mg/d). After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients initially assigned to pioglitazone were asked to continue at the same dose.
934555|NCT00994682|O1|Outcome|Placebo|Participants were prescribed a hypocaloric diet (500– kcal/d deficit from the calculated weight maintaining diet) and received placebo pills with identical physical characteristics and in identical bottles to pioglitazone pills. After 18 months of treatment, metabolic measurements (OGTT and euglycemic insulin clamp), DXA, 1H-MRS, and liver biopsy were repeated, at which point the medication code was disclosed to investigators and patients. Patients whose NASH resolved after 18 months were instructed to discontinue the study because pioglitazone treatment or a repeated liver biopsy were considered unethical and were not indicated, whereas those with persistent disease were invited to start open-label pioglitazone therapy, titrated as described for the other arm.
934565|NCT00994604|O1|Outcome|Broccoli Sprout Extract - BP|pre- and post-consumption of broccoli sprout extract for 2 weeks
934566|NCT00994604|E1|Reported Event|Broccoli Sprout Extract|pre- and post-consumption of broccoli sprout extract for 2 weeks
934567|NCT00994461|B4|Baseline|Total|Total of all reporting groups
934568|NCT00994461|B3|Baseline|Placebo|Placebo tablet three times a day with meal for 2 weeks
934569|NCT00994461|B2|Baseline|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934570|NCT00994461|B1|Baseline|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934571|NCT00994461|P3|Participant Flow|Placebo|Placebo tablet three times a day with meal for 2 weeks
934572|NCT00994461|P2|Participant Flow|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934573|NCT00994461|P1|Participant Flow|Celecoxib|Celecoxib 100 mg tablet twice a day with meal for 2 weeks
934574|NCT00994461|O3|Outcome|Placebo|Placebo tablet three times a day with meal for 2 weeks
934575|NCT00994461|O2|Outcome|Loxoprofen|Loxoprofen 60 mg tablet three times a day with meal for 2 weeks
934608|NCT00994422|B2|Baseline|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
934609|NCT00994422|B1|Baseline|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
934610|NCT00994422|P2|Participant Flow|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
934611|NCT00994422|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
934612|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
934613|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
934614|NCT00994422|O2|Outcome|Vehicle Control|Participants received a single application of vehicle control cream on Day 1.
934615|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin cream on Day 1.
934616|NCT00994422|O2|Outcome|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
934617|NCT00994422|O1|Outcome|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
934618|NCT00994422|E2|Reported Event|Placebo (Vehicle Control)|Participants received a single application of vehicle control cream on Day 1.
934619|NCT00994422|E1|Reported Event|0.5% Ivermectin|Participants received a single application of Ivermectin cream on Day 1.
934620|NCT00994318|B4|Baseline|Total|Total of all reporting groups
934621|NCT00994318|B3|Baseline|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
934622|NCT00994318|B2|Baseline|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
934623|NCT00994318|B1|Baseline|FCM (High Ferritin Target|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
934624|NCT00994318|P3|Participant Flow|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
934625|NCT00994318|P2|Participant Flow|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
934626|NCT00994318|P1|Participant Flow|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
934627|NCT00994318|O3|Outcome|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
934628|NCT00994318|O2|Outcome|FCM (Low Ferritin Level)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 100-200 mcg/L
934629|NCT00994318|O1|Outcome|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer), targeting ferritin level of 400-600 mcg/L
934630|NCT00994318|E3|Reported Event|Oral Iron|Ferrous sulphate 100 mg iron twice daily, continuous
934631|NCT00994318|E2|Reported Event|FCM (Low Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 100 - 200 mcg/L
934632|NCT00994318|E1|Reported Event|FCM (High Ferritin Target)|Ferric carboxymaltose (FCM) (Ferinject / Injectafer) targeting ferritin level of 400 - 600 mcg/L
934633|NCT00994279|B3|Baseline|Total|Total of all reporting groups
934634|NCT00994279|B2|Baseline|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
934635|NCT00994279|B1|Baseline|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
934636|NCT00994279|P2|Participant Flow|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
934637|NCT00994279|P1|Participant Flow|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
934638|NCT00994279|O2|Outcome|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
934639|NCT00994279|O1|Outcome|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
934640|NCT00994279|O2|Outcome|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
934641|NCT00994279|O1|Outcome|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
934642|NCT00994279|E2|Reported Event|Arm 2: Educational Wellness Group|"Educational Wellness Group~Education: Educational Wellness Group"
934643|NCT00994279|E1|Reported Event|Arm 1: Yoga Intervention|"Yoga Intervention~Yoga: Yoga sessions"
934644|NCT00994253|B3|Baseline|Total|Total of all reporting groups
934645|NCT00994253|B2|Baseline|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
934682|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
934683|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
934684|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
934646|NCT00994253|B1|Baseline|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
934647|NCT00994253|P2|Participant Flow|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
934648|NCT00994253|P1|Participant Flow|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
934649|NCT00994253|O2|Outcome|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
934650|NCT00994253|O1|Outcome|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
934651|NCT00994253|E2|Reported Event|Hydrochlorothiazide|"HCTZ will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day.~Patients will be assigned to the treatment arm containing HCTZ. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + HCTZ 12.5-25mg~Hydrochlorothiazide: Hydrochlorothiazide will be prescribed at 12.5 po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 25mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily"
934652|NCT00994253|E1|Reported Event|Aliskiren|"Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day.~Patients will be assigned to the treatment arm containing aliskiren. The prescribed drugs will include: Lisinopril 40mg + amlo 5mg + aliskiren 150-300mg~Aliskiren: Aliskiren will be prescribed at 150mg po per day. If the subjects blood pressure is not controlled by week 5 the dose will be increased to 300mg po per day. All subjects will be prescribed lisinopril 40mg and amlodipine 5mg po daily."
934653|NCT00994240|B3|Baseline|Total|Total of all reporting groups
934654|NCT00994240|B2|Baseline|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934655|NCT00994240|B1|Baseline|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934656|NCT00994240|P2|Participant Flow|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934657|NCT00994240|P1|Participant Flow|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934658|NCT00994240|O2|Outcome|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934659|NCT00994240|O1|Outcome|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934660|NCT00994240|E2|Reported Event|ED & C Times 1 Cycle|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934661|NCT00994240|E1|Reported Event|ED&C Times 3 Cycles|Electrodessication & Curettage: Electrodessication & Curettage 1 or 3 cycles
934662|NCT00994214|B5|Baseline|Total|Total of all reporting groups
934663|NCT00994214|B4|Baseline|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections..
934664|NCT00994214|B3|Baseline|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
934665|NCT00994214|B2|Baseline|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
934666|NCT00994214|B1|Baseline|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
934667|NCT00994214|P4|Participant Flow|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
934668|NCT00994214|P3|Participant Flow|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
934669|NCT00994214|P2|Participant Flow|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
934670|NCT00994214|P1|Participant Flow|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
934671|NCT00994214|O9|Outcome|Overall - Part B|
934672|NCT00994214|O8|Outcome|Part B: Arm D: BIM 23A760 6 mg|
934673|NCT00994214|O7|Outcome|Part B: Arm C: BIM 23A760 4 mg|
934674|NCT00994214|O6|Outcome|Part B: Arm B: BIM 23A760 2 mg|
934675|NCT00994214|O5|Outcome|Overall - Part A|
934676|NCT00994214|O4|Outcome|Part A: Arm D: BIM 23A760 6 mg|
934677|NCT00994214|O3|Outcome|Part A: Arm C: BIM 23A760 4 mg|
934678|NCT00994214|O2|Outcome|Part A: Arm B: BIM 23A760 2 mg|
934679|NCT00994214|O1|Outcome|Part A: Arm A: BIM 23A760 1 mg|
934680|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
934681|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections.
951411|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
934686|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
934687|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
934688|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
934689|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
934690|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections
934691|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections
934692|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections
934693|NCT00994214|O3|Outcome|Arm C: BIM 23A760 4 mg|BIM 23A760 4 mg subcutaneous 24 weekly injections
934694|NCT00994214|O2|Outcome|Arm B: BIM 23A760 2 mg|BIM 23A760 2 mg subcutaneous 24 weekly injections.
934695|NCT00994214|O1|Outcome|Arm A: BIM 23A760 1 mg|BIM 23A760 1 mg subcutaneous 24 weekly injections.
934696|NCT00994214|O4|Outcome|Arm D: BIM 23A760 6 mg|BIM 23A760 6 mg subcutaneous 24 weekly injections.
934714|NCT00994123|B3|Baseline|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
934715|NCT00994123|B2|Baseline|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
934716|NCT00994123|B1|Baseline|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 + Erlotinib in patients with NSCLC
934717|NCT00994123|P3|Participant Flow|Phase 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
934718|NCT00994123|P2|Participant Flow|Phase 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
934719|NCT00994123|P1|Participant Flow|Phase 1: MM-121 + Erlotinib|Escalating doses of MM-121 and erlotinib
934720|NCT00994123|O4|Outcome|HRG Low: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
934721|NCT00994123|O3|Outcome|HRG Low: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
934722|NCT00994123|O2|Outcome|HRG High: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
934723|NCT00994123|O1|Outcome|HRG High: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
934724|NCT00994123|O2|Outcome|Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
934725|NCT00994123|O1|Outcome|MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
934726|NCT00994123|O1|Outcome|Phase 1: All Participants|All participants in the dose escalation portion of the Phase 1
934727|NCT00994123|O7|Outcome|Cohort 7|MM-121 20 mg/kg (Q3W IV) + erlotinib 100 mg (PO daily)
934728|NCT00994123|O6|Outcome|Cohort 6|MM-121 20 mg/kg (Q2W IV) + erlotinib 100 mg (PO daily)
934729|NCT00994123|O5|Outcome|Cohort 5|MM-121 20 mg/kg (weekly IV) + erlotinib 100 mg (PO daily)
934730|NCT00994123|O4|Outcome|Cohort 4|MM-121 12 mg/kg (Q2W IV) + 150 mg erlotinib (PO daily)
934731|NCT00994123|O3|Outcome|Cohort 3|MM-121 12 mg/kg (Q2W IV) + 100 mg erlotinib (daily PO)
934732|NCT00994123|O2|Outcome|Cohort 2|6 mg/kg MM-121 Q2W + 150 mg erlotinib (daily PO)
934733|NCT00994123|O1|Outcome|Cohort 1|MM-121 6 mk/kg (Q2W IV) and 100 mg erlotinib (daily PO)
934734|NCT00994123|E3|Reported Event|Ph 1: MM-121 + Erlotinib|Escalating Doses of MM-121 + erlotinib
934735|NCT00994123|E2|Reported Event|Ph 2: Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~daily 150 mg erlotinib p.o. alone"
934736|NCT00994123|E1|Reported Event|Ph 2: MM-121 + Erlotinib|"EGFR wild-type, EGFR-TKI naive patients randomized to receive:~MM-121 every other week at a dose of 20 mg/kg IV in combination with daily 100 mg erlotinib p.o."
934737|NCT00994110|B3|Baseline|Total|Total of all reporting groups
934738|NCT00994110|B2|Baseline|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
934739|NCT00994110|B1|Baseline|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
934749|NCT00993954|P2|Participant Flow|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
935348|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
934740|NCT00994110|P2|Participant Flow|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
934754|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934755|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934835|NCT00993499|B5|Baseline|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934741|NCT00994110|P1|Participant Flow|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
934742|NCT00994110|O2|Outcome|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
934743|NCT00994110|O1|Outcome|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
934744|NCT00994110|E2|Reported Event|Placebo|"This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.~Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified."
934745|NCT00994110|E1|Reported Event|SOM230|This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.
934746|NCT00993954|B3|Baseline|Total|Total of all reporting groups
934747|NCT00993954|B2|Baseline|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934748|NCT00993954|B1|Baseline|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
951412|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
934750|NCT00993954|P1|Participant Flow|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934751|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934752|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934753|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934834|NCT00993499|B6|Baseline|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934756|NCT00993954|O2|Outcome|Physician Reduction|"Patients randomized to treatment by Emergency Department Physician in traditional ED manner~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934757|NCT00993954|O1|Outcome|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934758|NCT00993954|E2|Reported Event|Physician Reduction|"Patients randomized to reduction by physician~Physicians were free to use the reduction method of their choice"
934759|NCT00993954|E1|Reported Event|Nurse Reduction|"Patients randomized to reduction by nurse.~Reduction of Radial Head Subluxation: Nurse group will use hyperpronation with extension for first attempt and supination and flexion for second attempt. Physician controls will use either method at their discretion"
934760|NCT00993928|B3|Baseline|Total|Total of all reporting groups
934761|NCT00993928|B2|Baseline|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
934762|NCT00993928|B1|Baseline|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
934763|NCT00993928|P2|Participant Flow|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
934764|NCT00993928|P1|Participant Flow|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
934765|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934766|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934767|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934768|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934769|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934770|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934771|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.
934772|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.
934773|NCT00993928|O2|Outcome|Arm B: Home-based Sleep Intervention With Device #2|"Participants will listen to a pre-recorded mp3 device #2 before retiring to sleep. At the end of the study, participants assigned to pre-recorded mp3 device #2 will be offered pre-recorded mp3 device #1 for their own use.~Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
934774|NCT00993928|O1|Outcome|Arm A: Home-based Sleep Intervention With Device #1|"Participants listen to a pre-recorded mp3 device #1 before retiring to sleep. Only patients in Arm A will have assigned bed and wake times based on their baseline diary.~Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet."
934775|NCT00993928|E2|Reported Event|Arm B: Home-based Sleep Intervention With Device #2|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934776|NCT00993928|E1|Reported Event|Arm A: Home-based Sleep Intervention With Device #1|Home-based sleep intervention: Participants will be asked to practice behaviors consistent with the stimulus control sheet and to read the sleep hygiene booklet.
934777|NCT00993915|B1|Baseline|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934778|NCT00993915|P1|Participant Flow|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934779|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934780|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
935173|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
934781|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934782|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934783|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934784|NCT00993915|O1|Outcome|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934785|NCT00993915|E1|Reported Event|Atorvastatin|The use and dosage recommendations for Atorvastatin (Liprimar) were in accordance with the Local Product Development document. The recommended starting dose was 10 milligrams (mg) once daily, dosages adjusted as needed at intervals of 4 weeks or more, with a maximum dosage of 80 mg once daily.
934786|NCT00993824|B3|Baseline|Total|Total of all reporting groups
934787|NCT00993824|B2|Baseline|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
934788|NCT00993824|B1|Baseline|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
934789|NCT00993824|P2|Participant Flow|Placebo Then Welchol|Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
934790|NCT00993824|P1|Participant Flow|Welchol Then Placebo|3.75 grams of colesevelam HCl (Welchol) taken for 12 weeks at evening meal, and then crossover to placebo taken at evening meal fro 12 weeks.
934791|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
934792|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
934793|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
934794|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
934795|NCT00993824|O2|Outcome|Placebo Then Welchol|"Placebo taken for 12 weeks at evening meal, and then crossover to 3.75 grams of colesevelam HCl taken at evening meal fro 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
934796|NCT00993824|O1|Outcome|Welchol Then Placebo|"3.75 grams of colesevelam HCl (Welchol) at evening meal for 12 weeks, and then crossover to placebo at evening meal for 12 weeks.~colesevelam HCl: 3.75 grams of colesevelam HCl (6 tablets)~placebo"
934797|NCT00993824|O2|Outcome|Placebo Then Welchol|Placebo taken at evening meal for 12 weeks, then crossover to 3.75 grams of colesevelam HCl taken at evening meal for 12 weeks.
934798|NCT00993824|O1|Outcome|Welchol Then Placebo|3.75 grams of colesevelam HCl taken at evening meal for 12 weeks, then crossover to placebo taken at evening meal for 12 weeks.
934799|NCT00993824|E2|Reported Event|Placebo|Placebo taken at evening meal
934800|NCT00993824|E1|Reported Event|Welchol|3.75 grams of colesevelam HCl taken at evening meal
934801|NCT00993668|B3|Baseline|Total|Total of all reporting groups
934802|NCT00993668|B2|Baseline|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934803|NCT00993668|B1|Baseline|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934804|NCT00993668|P2|Participant Flow|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
935163|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
934805|NCT00993668|P1|Participant Flow|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934806|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934807|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934808|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934809|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934810|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934811|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934812|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934813|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934814|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934815|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934816|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934817|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934818|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934819|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934820|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934821|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934822|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934823|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934824|NCT00993668|O2|Outcome|Cimzia|Certolizumab pegol - Two 200 mg subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32).
934825|NCT00993668|O1|Outcome|Placebo|Placebo - Two 0.9% saline subcutaneous (sc) injections at Week 0, Week 2, and Week 4 followed by two sc injections of Open-Label (OL) CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of OL CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934826|NCT00993668|E3|Reported Event|Cimzia at Any Time|Certolizumab pegol (at any time) - Subjects randomized to receive Certolizumab pegol (CZP) during the single blind (SB) period will receive two subcutaneous (sc) injections of SB CZP 200 mg at Weeks 0, 2, and 4 followed by one sc injection of Open-Label (OL) CZP 200 mg from Week 6 until last drug administration (up to Week 32). Subjects randomized to placebo during the SB period will receive two 0.9% saline sc injections at Week 0, Week 2, and Week 4, followed by two sc injections of OL CZP 200 mg at Weeks 6, 8 and 10, then one sc injection of CZP 200 mg every two weeks from Week 12 until last drug administration (up to Week 32).
934827|NCT00993668|E2|Reported Event|Cimzia (Single Blind)|Certolizumab pegol - Two 200 mg subcutaneous injections at Week 0, Week 2, and Week 4
934828|NCT00993668|E1|Reported Event|Placebo (Single Blind)|Placebo - Two 0.9% saline subcutaneous injections at Week 0, Week 2, and Week 4
934860|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934829|NCT00993616|B1|Baseline|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
934830|NCT00993616|P1|Participant Flow|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
934831|NCT00993616|O1|Outcome|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
934832|NCT00993616|E1|Reported Event|Treatment|"Patients receive belinostat IV over 30 minutes on days 1-5 and carboplatin IV over 30-60 minutes on day 3. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who are clinically responding or who, in the opinion of their physician, would continue to benefit from treatment may continue treatment beyond 6 courses.~belinostat: Given IV~carboplatin: Given IV"
934833|NCT00993499|B7|Baseline|Total|Total of all reporting groups
951282|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
934836|NCT00993499|B4|Baseline|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934837|NCT00993499|B3|Baseline|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934838|NCT00993499|B2|Baseline|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934839|NCT00993499|B1|Baseline|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934840|NCT00993499|P6|Participant Flow|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934841|NCT00993499|P5|Participant Flow|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934842|NCT00993499|P4|Participant Flow|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934843|NCT00993499|P3|Participant Flow|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934844|NCT00993499|P2|Participant Flow|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934845|NCT00993499|P1|Participant Flow|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934846|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934847|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934848|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934849|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934850|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934851|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934852|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934853|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934854|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934855|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934856|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934857|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934858|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934859|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934861|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934862|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934863|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934864|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934865|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934866|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934867|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934868|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934869|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934870|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934871|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934872|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934873|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934874|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934875|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934876|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934877|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934878|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934879|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934880|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934881|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934882|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934883|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934884|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934885|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934886|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934887|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934888|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934889|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934890|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934891|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934892|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934893|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
951413|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
934894|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934895|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934896|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934897|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934898|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934899|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934900|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934901|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
951283|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
934902|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934903|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934904|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934905|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934906|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934907|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934908|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934909|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934910|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934911|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934912|NCT00993499|O6|Outcome|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934913|NCT00993499|O5|Outcome|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934914|NCT00993499|O4|Outcome|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934915|NCT00993499|O3|Outcome|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934916|NCT00993499|O2|Outcome|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934917|NCT00993499|O1|Outcome|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934918|NCT00993499|E6|Reported Event|Afa40+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 5mg tablet once daily.
934919|NCT00993499|E5|Reported Event|Afa40+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 40mg tablet once daily plus Sir 1mg tablet once daily.
934920|NCT00993499|E4|Reported Event|Afa30+Sir10|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 10mg tablet once daily.
934921|NCT00993499|E3|Reported Event|Afa30+Sir05|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 5mg tablet once daily.
934922|NCT00993499|E2|Reported Event|Afa30+Sir03|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 3mg tablet once daily.
934923|NCT00993499|E1|Reported Event|Afa30+Sir01|Patients received Sirolimus (Sir) 1mg tablet orally for 8 days, followed by oral administration of Afatinib (Afa) 30mg tablet once daily plus Sir 1mg tablet once daily.
934924|NCT00993473|B3|Baseline|Total|Total of all reporting groups
934925|NCT00993473|B2|Baseline|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934926|NCT00993473|B1|Baseline|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934927|NCT00993473|P2|Participant Flow|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934928|NCT00993473|P1|Participant Flow|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934929|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934930|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934931|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934932|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934933|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
935363|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
934934|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934935|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934936|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934937|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934938|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934939|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934940|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934941|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934942|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934943|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934944|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934945|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934946|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934947|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934948|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934949|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934950|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934951|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934952|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934953|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934954|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934955|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
951414|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
934956|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934957|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934958|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934959|NCT00993473|O2|Outcome|NPH Insulin|"Neutral Protamine Hagedorn (NPH) human insulin given as basal insulin either once or twice per day by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934960|NCT00993473|O1|Outcome|Lantus (Insulin Glargine)|"Lantus (insulin glargine) given as basal insulin once a day in the morning by subcutaneous injection.~Dose: titrated to achieve glycemic targets as described in protocol section."
934961|NCT00993473|E2|Reported Event|NPH Insulin|
934962|NCT00993473|E1|Reported Event|Lantus|
934963|NCT00993447|B3|Baseline|Total|Total of all reporting groups
934964|NCT00993447|B2|Baseline|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934965|NCT00993447|B1|Baseline|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934966|NCT00993447|P2|Participant Flow|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934967|NCT00993447|P1|Participant Flow|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934968|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934969|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934970|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934971|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934972|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934973|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934974|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934975|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934976|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934977|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934978|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934979|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934980|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934981|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934982|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934983|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934984|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934985|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934986|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934987|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934988|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934989|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
935442|NCT00992589|O1|Outcome|Double-Blind Placebo - Baseline|Matching placebo capsules once daily in the morning.
934990|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934991|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934992|NCT00993447|O2|Outcome|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934993|NCT00993447|O1|Outcome|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934994|NCT00993447|E2|Reported Event|Control Group|Participants received a placebo (NaCl) as first (Day 0) and second (Day 0 + 6 months) injections and ADACEL vaccine as a third (Day 0 + 12 months) injection.
934995|NCT00993447|E1|Reported Event|Dengue Vaccine Group|Participants received the 5555 formulation of Sanofi Pasteur's CYD dengue vaccine as first (Day 0), second (Day 0 + 6 months), and third (Day 0 + 12 months) injections.
934996|NCT00993421|B8|Baseline|Total|Total of all reporting groups
934997|NCT00993421|B7|Baseline|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
934998|NCT00993421|B6|Baseline|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
936515|NCT00989014|E4|Reported Event|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
934999|NCT00993421|B5|Baseline|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935000|NCT00993421|B4|Baseline|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935001|NCT00993421|B3|Baseline|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935002|NCT00993421|B2|Baseline|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935003|NCT00993421|B1|Baseline|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935004|NCT00993421|P7|Participant Flow|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935005|NCT00993421|P6|Participant Flow|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935006|NCT00993421|P5|Participant Flow|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935007|NCT00993421|P4|Participant Flow|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935008|NCT00993421|P3|Participant Flow|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935009|NCT00993421|P2|Participant Flow|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935010|NCT00993421|P1|Participant Flow|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935011|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935012|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935013|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935014|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935015|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935016|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935017|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935018|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935019|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935020|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935021|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935022|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935023|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935024|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935025|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935026|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935027|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935028|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935029|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935030|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935031|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935032|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935033|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935034|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935035|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935036|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935037|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935038|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935039|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935040|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935041|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935042|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935043|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935044|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935045|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935046|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935047|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935048|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
936134|NCT00990704|P1|Participant Flow|Paricalcitol|2 mcg with incremental of 1 mcg
935049|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935050|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935051|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935052|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935053|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935054|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935055|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935056|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935583|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935057|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935058|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935059|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935060|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935061|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935062|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935063|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935064|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935065|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935066|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935067|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935068|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935069|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935070|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935071|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935072|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935073|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935074|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935075|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935076|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935077|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935078|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935079|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935080|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935081|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935082|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935083|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935084|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935174|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935493|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935085|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935086|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935087|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935088|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935089|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935090|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935091|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935092|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935093|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935094|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935095|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935096|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935097|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935098|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935099|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935100|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935101|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935102|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935103|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935104|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935105|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935106|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935107|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935108|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935109|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935110|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935111|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935112|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935175|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935494|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935113|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935114|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935115|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935116|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935117|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935118|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935119|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935120|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935121|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935122|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935123|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935124|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935125|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935126|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935127|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935128|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935129|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935130|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935131|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935132|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935133|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935134|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935135|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935136|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935137|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935138|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935139|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935140|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935176|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935495|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935141|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935142|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935143|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935144|NCT00993421|O7|Outcome|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935145|NCT00993421|O6|Outcome|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935146|NCT00993421|O5|Outcome|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935147|NCT00993421|O4|Outcome|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks."
935148|NCT00993421|O3|Outcome|Sibutramine (30 mg)/Metoprolol (200 mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by a 2 week taper - 1 week at 100 mg/day followed by 1 week at 50 mg/day.~Placebo LY377604: given orally, daily for 24 weeks."
935149|NCT00993421|O2|Outcome|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935150|NCT00993421|O1|Outcome|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935151|NCT00993421|E7|Reported Event|LY377604 (75 mg)/Sibutramine (15 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (15 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935152|NCT00993421|E6|Reported Event|LY377604 (75 mg)/Sibutramine (30 mg)|"LY377604 (75 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935153|NCT00993421|E5|Reported Event|LY377604 (40 mg)/Sibutramine (30 mg)|"LY377604 (40 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935154|NCT00993421|E4|Reported Event|LY377604 (15 mg)/Sibutramine (30 mg)|"LY377604 (15 mg): Given orally, daily for 24 weeks.~sibutramine (30 mg): Given orally, daily for 24 weeks.~Placebo metoprolol: Given orally, daily for 24 weeks, followed by 2 week taper."
935155|NCT00993421|E3|Reported Event|Sibutramine (30mg)/Metoprolol (200mg)|"sibutramine (30 mg): Given orally, daily for 24 weeks.~metoprolol (200 mg): Given orally, daily 100 mg for 1 week followed by 200 mg for 23 weeks (Patients unable to tolerate 200 mg will be dose reduced to 100 mg), followed by 2 week taper (1 week at 100 mg/day followed by 1 week at 50 mg/day).~Placebo LY377604: given orally, daily for 24 weeks."
935156|NCT00993421|E2|Reported Event|LY377604 (75 mg)|Given orally, daily for 24 weeks.
935157|NCT00993421|E1|Reported Event|Placebo|"Placebo LY377604: given orally, daily for 24 weeks.~Placebo sibutramine: given orally, daily for 24 weeks.~Placebo metoprolol: given orally, daily for 24 weeks, followed by 2 week taper."
935158|NCT00993317|B3|Baseline|Total|Total of all reporting groups
935159|NCT00993317|B2|Baseline|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935160|NCT00993317|B1|Baseline|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935161|NCT00993317|P2|Participant Flow|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935162|NCT00993317|P1|Participant Flow|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935164|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935165|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935166|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935167|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935168|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935169|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935170|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935171|NCT00993317|O2|Outcome|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935172|NCT00993317|O1|Outcome|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935177|NCT00993317|E2|Reported Event|CDP870 200mg+MTX|Certolizumab pegol for subcutaneous injection is supplied in a 1 ml pre-filled syringe (PFS) for single use at dosage strength of 200 mg/ml.
935178|NCT00993317|E1|Reported Event|Placebo of CDP870+MTX|0.9% saline solution (preservative free) given as two 1ml injections of PFS at Baseline, Weeks 2 and 4, then every two weeks given as one 1ml injection of PFS.
935179|NCT00993291|B1|Baseline|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
935180|NCT00993291|P1|Participant Flow|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
935181|NCT00993291|O1|Outcome|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
935182|NCT00993291|E1|Reported Event|Baseline Frequency|Gait analysis at the subjects baseline DBS frequency
935183|NCT00993265|B3|Baseline|Total|Total of all reporting groups
935184|NCT00993265|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935185|NCT00993265|B1|Baseline|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935186|NCT00993265|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935187|NCT00993265|P1|Participant Flow|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935188|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935189|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935190|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935191|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935192|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935193|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935194|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935195|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935196|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935197|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935443|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
935198|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935199|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935200|NCT00993265|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935201|NCT00993265|O1|Outcome|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935202|NCT00993265|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~Placebo: placebo, 2 capsules by mouth in AM, 2 capsules by mouth PM, 12 weeks"
935203|NCT00993265|E1|Reported Event|N-acetylcysteine (NAC)|"Patients randomized to this arm will receive N-Acetylcysteine, at a standard dose titrated to 2400 mg. They will receive NAC in addition to the medication regimen they are on at enrollment.~N-Acetylcysteine: 2400 mg by mouth PO (1200 mg AM, 1200 mg PM), 12 weeks"
935204|NCT00993200|B3|Baseline|Total|Total of all reporting groups
951284|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
935205|NCT00993200|B2|Baseline|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
935206|NCT00993200|B1|Baseline|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
935207|NCT00993200|P2|Participant Flow|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
935208|NCT00993200|P1|Participant Flow|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
935209|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
935210|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
935211|NCT00993200|O2|Outcome|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
935212|NCT00993200|O1|Outcome|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
935213|NCT00993200|O2|Outcome|PERMIT|Warfarin management with use of gene-based warfarin dosing algorithm
935214|NCT00993200|O1|Outcome|Standard|Standard of care warfarin management
935215|NCT00993200|E2|Reported Event|Warfarin: PERMIT|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by genetic guided warfarin dosing incorporated into the PERMIT algorithm.
935216|NCT00993200|E1|Reported Event|Warfarin, Control|Subjects naive to warfarin therapy with anticipated warfarin duration of at least 12 weeks managed by usual care dosing.
935217|NCT00993187|B3|Baseline|Total|Total of all reporting groups
935218|NCT00993187|B2|Baseline|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935219|NCT00993187|B1|Baseline|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935220|NCT00993187|P2|Participant Flow|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935221|NCT00993187|P1|Participant Flow|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935222|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935223|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935224|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935287|NCT00992836|P1|Participant Flow|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
935225|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935226|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935227|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935228|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935229|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935230|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935231|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935232|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935233|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935234|NCT00993187|O2|Outcome|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935235|NCT00993187|O1|Outcome|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935236|NCT00993187|E2|Reported Event|Glimepiride|Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
935237|NCT00993187|E1|Reported Event|Sitagliptin/Metformin|Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
935238|NCT00993148|B1|Baseline|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935239|NCT00993148|P1|Participant Flow|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935240|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935241|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935242|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935243|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935244|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935245|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935246|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935247|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935248|NCT00993148|O1|Outcome|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935249|NCT00993148|E1|Reported Event|Maraviroc + Darunavir/Ritonavir|maraviroc 150 mg plus darunavir/ritonavir 800/100 mg once daily
935250|NCT00993044|B1|Baseline|Dose Level 1, 2|
935251|NCT00993044|P1|Participant Flow|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
951415|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
935252|NCT00993044|O1|Outcome|Single Arm|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 1.5* Irinotecan 40 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5~Dose Level -1 Irinotecan 20 mg/m2/day IV on day 1,2,3,4 and 5~* Dose escalation will proceed from dose level 1 to dose level 2 and de-escalate to dose level 1.5 if DLT is observed"
935253|NCT00993044|E2|Reported Event|Dose Level 2|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 2 Irinotecan 50 mg/m2/day IV on day 1,2,3,4 and 5"
935254|NCT00993044|E1|Reported Event|Dose Level 1|"combination of Irinotecan, vincristine, temozolomide and bevacizumab: Vincristine 1.5mg/m2 (2mg max dose) IV on day 1,8 Temozolomide 100 mg/m2 PO on day 1,2,3,4 and 5 Bevacizumab 15mg/kg IV on day 1~Dose Level 1 Irinotecan 30 mg/m2/day IV on day 1,2,3,4 and 5"
935255|NCT00992992|B1|Baseline|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935301|NCT00992784|B1|Baseline|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935302|NCT00992784|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935256|NCT00992992|P1|Participant Flow|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935257|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935258|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935259|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935260|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935261|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
936135|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
935262|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935263|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935303|NCT00992784|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935304|NCT00992784|P1|Participant Flow|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935305|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935306|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935307|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935264|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935265|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935266|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935267|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935268|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935269|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935270|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935271|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935308|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935309|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935310|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935311|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935312|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
936516|NCT00989014|E3|Reported Event|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
935272|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935273|NCT00992992|O1|Outcome|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935274|NCT00992992|E1|Reported Event|Iodine I-131 Tositumomab + CHOP|Participants (par.) with previously untreated mantle cell lymphoma (MCL) were dosed with iodine I-131 tositumomab in two phases, followed by six cycles (21 days per cycle) of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP). In the first phase (dosimetric dose), par. received an infusion of unlabeled tositumomab (450 milligrams [mg]) over the course of 60 minutes, followed by a 30-minute infusion of tositumomab (35 mg) containing 5 millicurie (mCi) of iodine-131. In the second phase (therapeutic dose), par. received a 60-minute infusion of tositumomab (450 mg), followed by a 30-minute infusion of 35 mg tositumomab containing a participant-specific dose of iodine-131. This dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
935275|NCT00992927|B3|Baseline|Total|Total of all reporting groups
935276|NCT00992927|B2|Baseline|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
935277|NCT00992927|B1|Baseline|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
935278|NCT00992927|P2|Participant Flow|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
935279|NCT00992927|P1|Participant Flow|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
935280|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
935281|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
935282|NCT00992927|O2|Outcome|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
935283|NCT00992927|O1|Outcome|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
935284|NCT00992927|E2|Reported Event|CRIHD|Capsule-Rupturing Intra-articular Hydraulic Distension (CRIHD) infuses fluid into the joint space until the rupture of the capsule is observed.
935285|NCT00992927|E1|Reported Event|CPIHD|Capsule-Preserving Intra-articular Hydraulic Distension (CPIHD) infuses as much volume as possible during the distension without rupturing the capsule.
935286|NCT00992836|B1|Baseline|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
935288|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
935289|NCT00992836|O1|Outcome|Influenza A (H1N1) 2009 Monovalent Vaccine|"All participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart.~Influenza A (H1N1) 2009 monovalent vaccine: Two doses of vaccine, delivered 21 days apart, with each dose consisting of two 15-microgram intramuscular injections"
935290|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 68, those who received the vaccinations and had enough samples for testing.
935291|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140, 142 and 138, for the analysis of antibody titers after the first and second vaccinations and after 6 months after the second vaccination, respectively.
935292|NCT00992836|O1|Outcome|Overall|The total N for this analysis was 138, those who received both vaccinations and had nonmissing data.
935293|NCT00992836|O1|Outcome|Overall|The total N for these analyses were 140 and 142, for the analysis of antibody titers after the first and second vaccinations, respectively.
935294|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
935295|NCT00992836|O1|Outcome|Vaccinated Study Participants|The 154 study participants who received at last one vaccination are included in this analysis.
935296|NCT00992836|O1|Outcome|All Study Participants|All 155 study participants are included in this analysis.
935297|NCT00992836|E1|Reported Event|All Study Participants|Participants received two doses of the H1N1 influenza virus vaccine, administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
935298|NCT00992784|B4|Baseline|Total|Total of all reporting groups
935299|NCT00992784|B3|Baseline|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935300|NCT00992784|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
936517|NCT00989014|E2|Reported Event|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
935313|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935314|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935315|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935316|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935317|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935318|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935319|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935320|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935321|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935322|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935323|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935324|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935325|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935326|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935327|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935328|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935329|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935330|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935331|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935332|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935333|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935334|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935335|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935336|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935337|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935338|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935339|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935340|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935341|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935342|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935343|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935344|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935345|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935346|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935347|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935349|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935350|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935351|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935352|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935353|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935354|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935355|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935356|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935357|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935358|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935359|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935360|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935361|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935362|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935364|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935365|NCT00992784|O3|Outcome|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935366|NCT00992784|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935367|NCT00992784|O1|Outcome|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935368|NCT00992784|E3|Reported Event|Fluarix Young Group|Subjects aged 19-43 years receiving 1 dose of Fluarix vaccine
935369|NCT00992784|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years receiving 1 dose of Fluarix vaccine
935370|NCT00992784|E1|Reported Event|New Generation Influenza Vaccine GSK2186877A Group|Subjects aged ≥ 66 years receiving 1 dose of New generation influenza vaccine GSK2186877A
935371|NCT00992719|B4|Baseline|Total|Total of all reporting groups
935372|NCT00992719|B3|Baseline|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935373|NCT00992719|B2|Baseline|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935374|NCT00992719|B1|Baseline|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935375|NCT00992719|P3|Participant Flow|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935376|NCT00992719|P2|Participant Flow|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935377|NCT00992719|P1|Participant Flow|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935378|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935379|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935380|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935381|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935382|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935383|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935384|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935385|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935386|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935387|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935388|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935389|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935390|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935391|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935392|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935393|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935394|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935395|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935396|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935397|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935398|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935399|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935400|NCT00992719|O3|Outcome|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935401|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935402|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935403|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935404|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935405|NCT00992719|O2|Outcome|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935406|NCT00992719|O1|Outcome|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935407|NCT00992719|E3|Reported Event|Group 3: Non-pregnant Women: 15 Mcg H1N1 Vaccine|Non-pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935408|NCT00992719|E2|Reported Event|Group 2: Pregnant Women: 30 Mcg H1N1 Vaccine|Pregnant participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935409|NCT00992719|E1|Reported Event|Group 1: Pregnant Women: 15 Mcg H1N1 Vaccine|Pregnant participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0
935410|NCT00992589|B1|Baseline|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935411|NCT00992589|P4|Participant Flow|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935412|NCT00992589|P3|Participant Flow|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935413|NCT00992589|P2|Participant Flow|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935414|NCT00992589|P1|Participant Flow|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935415|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
935416|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935417|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935418|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935419|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
935420|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935421|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935422|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935423|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
935424|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935425|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935426|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935427|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
935428|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935429|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935430|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935431|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
935432|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935433|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935434|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935435|NCT00992589|O8|Outcome|Double-Blind Rabeprazole Sodium Total - Week 8|Rabeprazole Sodium capsules once daily in the morning.
935436|NCT00992589|O7|Outcome|Double-Blind Rabeprazole Sodium Total - Baseline|Rabeprazole Sodium capsules once daily in the morning.
935437|NCT00992589|O6|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
935438|NCT00992589|O5|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Week 8|Rabeprazole Sodium capsules once daily in the morning.
935439|NCT00992589|O4|Outcome|Double-Blind Placebo - Week 8|Matching placebo capsules once daily in the morning.
935440|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
935441|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg - Baseline|Rabeprazole Sodium capsules once daily in the morning.
935444|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935445|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935446|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935447|NCT00992589|O4|Outcome|Double-Blind Rabeprazole Sodium Total|Rabeprazole Sodium capsules once daily in the morning.
935448|NCT00992589|O3|Outcome|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935449|NCT00992589|O2|Outcome|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935450|NCT00992589|O1|Outcome|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935451|NCT00992589|E4|Reported Event|Double-Blind Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935452|NCT00992589|E3|Reported Event|Double-Blind Rabeprazole Sodium 5 mg|Rabeprazole Sodium capsules once daily in the morning.
935453|NCT00992589|E2|Reported Event|Double-Blind Placebo|Matching placebo capsules once daily in the morning.
935454|NCT00992589|E1|Reported Event|Open-Label Rabeprazole Sodium 10 mg|Rabeprazole Sodium capsules once daily in the morning.
935455|NCT00992459|B3|Baseline|Total|Total of all reporting groups
935456|NCT00992459|B2|Baseline|Treatment Arm B|Patients randomized to receive HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 1) followed by NaPBA + HPN-100 placebo for 2 weeks (Treatment Period 2)
951285|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
935457|NCT00992459|B1|Baseline|Treatment Arm A|Patients randomized to receive NaPBA + HPN 100 placebo for 2 weeks (Treatment Period 1) followed by HPN-100 + NaPBA placebo for 2 weeks (Treatment Period 2)
935458|NCT00992459|P2|Participant Flow|Arm B|Subjects in Arm B were assigned to receive HPN-100 + NaPBA placebo for 2 weeks All patients in Arm B received NaPBA placebo (+ concomitant active HPN 100)
935459|NCT00992459|P1|Participant Flow|Arm A|Subjects in Arm A were assigned to receive NaPBA + HPN 100 placebo for 2 weeks All patients in Arm A received HPN100 placebo (+ concomitant active NaPBA)
935460|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935461|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935462|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935463|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935464|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935465|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935466|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935467|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935468|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935469|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935470|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935471|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935472|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935473|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935474|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935475|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935476|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935477|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935478|NCT00992459|O2|Outcome|HPN-100|Patients treated with HPN-100
935479|NCT00992459|O1|Outcome|NaPBA|Patients treated with NaPBA
935480|NCT00992459|E2|Reported Event|HPN-100|Patients received HPN-100
935481|NCT00992459|E1|Reported Event|NaPBA|Patients received NaPBA
935482|NCT00992446|B1|Baseline|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
935483|NCT00992446|P1|Participant Flow|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
935484|NCT00992446|O1|Outcome|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
935527|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935528|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935529|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935530|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935485|NCT00992446|O1|Outcome|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
935486|NCT00992446|E1|Reported Event|Treatment (Chemotherapy, ASCT, Bortezomib, Vorinostat))|"All patients receive carmustine IV over 3 hours on day -7; cytarabine IV BID over 3 hours and etoposide IV BID over 2 hours on days -6 to -3; and melphalan IV over 30 minutes on day -2. Only patients with history of CD20+ NHL receive additional rituximab IV on days -19 and -12. Patients undergo ASCT on day 0. Patients then receive bortezomib IV on days 2 and 8, and vorinostat PO QD on days 1-14. Treatment with bortezomib and vorinostat repeats for total of 12 courses in the absence of disease progression or unacceptable toxicity.~Autologous Hematopoietic Stem Cell Transplantation: Undergo ASCT~Bortezomib: Given IV~Carmustine: Given IV~Cytarabine: Given IV~Etoposide: Given IV~Melphalan: Given IV~Rituximab: Given IV~Vorinostat: Given PO"
935487|NCT00992433|B3|Baseline|Total|Total of all reporting groups
935488|NCT00992433|B2|Baseline|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935489|NCT00992433|B1|Baseline|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935490|NCT00992433|P2|Participant Flow|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935491|NCT00992433|P1|Participant Flow|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935492|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935496|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935497|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935498|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935499|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935500|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935501|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935502|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935503|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935504|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935505|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935506|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935507|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935508|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935509|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935510|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935511|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935512|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935513|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935514|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935515|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935516|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935517|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935518|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935519|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935520|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935521|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935522|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935523|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935524|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935525|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935526|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
936136|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
935531|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935532|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935533|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935534|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935535|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935536|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935537|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935538|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935539|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935540|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935541|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935542|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935543|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935544|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935545|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935546|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935547|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935548|NCT00992433|O2|Outcome|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935549|NCT00992433|O1|Outcome|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935550|NCT00992433|E2|Reported Event|30 Mcg H1N1 Vaccine|30 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935551|NCT00992433|E1|Reported Event|15 Mcg H1N1 Vaccine|15 mcg inactivated influenza H1N1 vaccine administered intramuscularly on Day 0 and Day 21.
935552|NCT00992407|B3|Baseline|Total|Total of all reporting groups
935553|NCT00992407|B2|Baseline|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935554|NCT00992407|B1|Baseline|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935555|NCT00992407|P2|Participant Flow|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935556|NCT00992407|P1|Participant Flow|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935557|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935558|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935559|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935560|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935561|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935562|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935563|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935564|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935565|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935566|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935567|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935568|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935569|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935570|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935571|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935572|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935573|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablets were administered orally as 0.5–10 mg daily up to Week 52.
935574|NCT00992407|O1|Outcome|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935575|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935576|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935577|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935578|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935579|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935580|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935581|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935582|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
936518|NCT00989014|E1|Reported Event|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
935584|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935585|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935586|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935587|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935588|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935589|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935590|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935591|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935592|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935593|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935594|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935595|NCT00992407|O2|Outcome|Risperidone Tablet|Risperidone tablet were administered orally as 0.5–10 mg daily up to Week 52.
935596|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935597|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935598|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935599|NCT00992407|O2|Outcome|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935600|NCT00992407|O1|Outcome|Risperidone Long Acting Injectables|Risperidone long acting injectables were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935601|NCT00992407|E2|Reported Event|Risperidone Tablets|Risperidone tablets were administered orally as 0.5-10 mg daily up to Week 52.
935602|NCT00992407|E1|Reported Event|Risperidone Injection|Risperidone long acting injectable (LAI) were administered intramuscularly (given into the skin) at a flexible dose of 25, 37.5 or 50 milligram (mg) every 2 weeks up to Week 52.
935603|NCT00992394|B3|Baseline|Total|Total of all reporting groups
935604|NCT00992394|B2|Baseline|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935605|NCT00992394|B1|Baseline|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935606|NCT00992394|P2|Participant Flow|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935607|NCT00992394|P1|Participant Flow|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935608|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935609|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935610|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935611|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935612|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935613|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935614|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935615|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935701|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935616|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935617|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935618|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935619|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935620|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935621|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935622|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935623|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935624|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935625|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935626|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935627|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935628|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935629|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935630|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935631|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935632|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935633|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935634|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935992|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935635|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935636|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935637|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935638|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935639|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935640|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935641|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935946|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935642|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935643|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935644|NCT00992394|O2|Outcome|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935645|NCT00992394|O1|Outcome|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935646|NCT00992394|E2|Reported Event|Maintenance Arm|Participants randomized to continue on treatment with etanercept at 25 mg once weekly, but with the option to have their drug treatment increased to 50 mg once weekly after medical review and agreement between the participant and the investigator
935647|NCT00992394|E1|Reported Event|Stop Arm|Participants randomized to stop their etanercept treatment on entry into the study and could be retreated by etanercept 50 mg once weekly after medical review and agreement between the participant and the investigator
935648|NCT00992264|B17|Baseline|Total|Total of all reporting groups
935649|NCT00992264|B16|Baseline|Randomization Arm: 16|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [no].
935650|NCT00992264|B15|Baseline|Randomization Arm: 15|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [no].
935651|NCT00992264|B14|Baseline|Randomization Arm: 14|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [no].
935652|NCT00992264|B13|Baseline|Randomization Arm: 13|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [no].
935653|NCT00992264|B12|Baseline|Randomization Arm: 12|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [no], and testimonials [yes].
935654|NCT00992264|B11|Baseline|Randomization Arm: 11|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [no], and testimonials [yes].
935655|NCT00992264|B10|Baseline|Randomization Arm: 10|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
935656|NCT00992264|B9|Baseline|Randomization Arm: 9|Persons assigned to this arm received the following intervention combination: Tone [motivational], Navigation [dictated], proactive emails [yes], and testimonials [yes].
935657|NCT00992264|B8|Baseline|Randomization Arm: 8|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [no].
935658|NCT00992264|B7|Baseline|Randomization Arm: 7|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [no].
935659|NCT00992264|B6|Baseline|Randomization Arm: 6|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [no].
935660|NCT00992264|B5|Baseline|Randomization Arm: 5|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [no].
935661|NCT00992264|B4|Baseline|Randomization Arm: 4|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [no], and testimonials [yes].
935662|NCT00992264|B3|Baseline|Randomization Arm: 3|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [no], and testimonials [yes].
935663|NCT00992264|B2|Baseline|Radndomization Arm: 2|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [not dictated], proactive emails [yes], and testimonials [yes].
935664|NCT00992264|B1|Baseline|Randomization Arm: 1|Persons assigned to this arm received the following intervention combination: Tone [prescriptive], Navigation [dictated], proactive emails [yes], and testimonials [yes].
935665|NCT00992264|P16|Participant Flow|Randomization Arm 16|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [no]
935666|NCT00992264|P15|Participant Flow|Randomization Arm 15|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [no]
935667|NCT00992264|P14|Participant Flow|Randomization Arm 14|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [no]
935668|NCT00992264|P13|Participant Flow|Randomization Arm 13|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [no]
935669|NCT00992264|P12|Participant Flow|Randomization Arm 12|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [no], and testimonials [yes]
935670|NCT00992264|P11|Participant Flow|Randomization Arm 11|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [no], and testimonials [yes]
935671|NCT00992264|P10|Participant Flow|Randomization Arm 10|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [not dictated], proactive emails [yes], and testimonials [yes]
935672|NCT00992264|P9|Participant Flow|Randomization Arm 9|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [motivational], navigation [dictated], proactive emails [yes], and testimonials [yes]
935673|NCT00992264|P8|Participant Flow|Randomization Arm 8|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [no]
935674|NCT00992264|P7|Participant Flow|Randomization Arm 7|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [no]
935675|NCT00992264|P6|Participant Flow|Randomization Arm 6|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [no]
935676|NCT00992264|P5|Participant Flow|Randomization Arm 5|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [no]
935677|NCT00992264|P4|Participant Flow|Randomization Arm 4|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [no], and testimonials [yes]
935678|NCT00992264|P3|Participant Flow|Randomization Arm 3|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [no], and testimonials [yes]
935679|NCT00992264|P2|Participant Flow|Randomization Arm 2|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [not dictated], proactive emails [yes], and testimonials [yes]
935680|NCT00992264|P1|Participant Flow|Randomization Arm 1|Persons in this group are randomized to the following combination of each of the experimental factors: message tone [prescriptive], navigation [dictated], proactive emails [yes], and testimonials [yes]
935681|NCT00992264|O4|Outcome|Proactive Emails|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
935682|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.~Persons in the comparison group could freely navigate the website."
935683|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.~Persons in the comparison group did not receive the testimonial content."
935684|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.~Persons in the comparison group received content written in a motivational message tone."
935685|NCT00992264|O4|Outcome|Proactive Outreach|"Persons in the active comparison group were randomized to receive periodic email reminders to return to the intervention website.~Persons in the comparison group did not receive proactive email reminders."
935686|NCT00992264|O3|Outcome|Navigation: Dictated|"Persons in the 'active' comparison group had their navigation through the website dictated based on their baseline readiness to quit smoking.~Persons in the comparison group could freely navigate the website."
935687|NCT00992264|O2|Outcome|Testimonials|"Persons in the 'active' comparison group were randomized to receive a personally tailored testimonial.~Persons in the comparison group did not receive the testimonial content."
935688|NCT00992264|O1|Outcome|Message Tone: Prescriptive|"Persons in the 'active' comparison group received website content written in a prescriptive message tone.~Persons in the comparison group received content written in a motivational message tone."
935689|NCT00992264|E4|Reported Event|Proactive Outreach|"Email or No-Email communication~Persons are randomized to receive periodic email reminders to return to the intervention website or not."
935690|NCT00992264|E3|Reported Event|Navigation|"Dictated or Non-Dictated~Persons are randomly assigned to be able to freely navigate the website or to have their navigation of the website pre-determined based on their baseline readiness to quit smoking."
935691|NCT00992264|E2|Reported Event|Testimonials|"Testimonial or No Testimonial~Persons are randomized to receive a personally tailored testimonial or not."
935692|NCT00992264|E1|Reported Event|Message Tone|"Prescriptive or Motivational~Persons are randomized to receive intervention content written in either a prescriptive or motivational tone."
935693|NCT00992186|B1|Baseline|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935694|NCT00992186|P1|Participant Flow|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935695|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935696|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935697|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935698|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935699|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935700|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
936519|NCT00988884|B3|Baseline|Total|Total of all reporting groups
935702|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935703|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935704|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935705|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935706|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935707|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5% dextrose administered at the dose of 15 mg/kg by intravenous infusion at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935708|NCT00992186|O1|Outcome|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935709|NCT00992186|E1|Reported Event|Carlumab|Carlumab diluted in 5 percent (%) dextrose administered at the dose of 15 milligram per kilogram (mg/kg) by intravenous (into a vein) infusion (a fluid or a medicine delivered into a vein by way of a needle) at a constant rate over a 90 minute period once every 2 weeks until disease progression.
935710|NCT00992108|B3|Baseline|Total|Total of all reporting groups
935711|NCT00992108|B2|Baseline|Botulinum|chemodenervation: botulinum toxin
935712|NCT00992108|B1|Baseline|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
935713|NCT00992108|P2|Participant Flow|Botulinum|chemodenervation: botulinum toxin
935714|NCT00992108|P1|Participant Flow|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
935715|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
935716|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
935717|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
935718|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
935719|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
935720|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
935721|NCT00992108|O2|Outcome|Botulinum|chemodenervation: botulinum toxin
935722|NCT00992108|O1|Outcome|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
935723|NCT00992108|E2|Reported Event|Botulinum|chemodenervation: botulinum toxin
935724|NCT00992108|E1|Reported Event|Lidocaine|"lidocaine injection group~lidocaine: 1cc 1%"
935725|NCT00992056|B3|Baseline|Total|Total of all reporting groups
935726|NCT00992056|B2|Baseline|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50 mg titrated to 100 mg
935727|NCT00992056|B1|Baseline|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then Nebivolol 5 mg titrated to 10 mg
935728|NCT00992056|P2|Participant Flow|Metoprolol/Nebivolol|Metoprolol 50 mg titrated to 100 mg then nebivolol 5 mg titrated to 10 mg
935729|NCT00992056|P1|Participant Flow|Nebivolol/Metoprolol|Nebivolol 5 mg titrated to 10 mg then Metoprolol 50mg titrated to 100 mg.
935730|NCT00992056|O2|Outcome|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
935731|NCT00992056|O1|Outcome|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
935732|NCT00992056|E2|Reported Event|Nebivolol|Participants who received Nebivolol 5 mg daily increased to 10 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 20 mg.
935733|NCT00992056|E1|Reported Event|Metoprolol|Participants who received Metoprolol 50 mg daily increased to 100 mg daily. If goal blood pressure (<140/<90 mmHg) was not achieved at week 3, the metoprolol was titrated to 200 mg.
935993|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935734|NCT00992017|B1|Baseline|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
935735|NCT00992017|P1|Participant Flow|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
935736|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
935737|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
935738|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
935739|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received the H1N1 vaccines.
935740|NCT00992017|O1|Outcome|Infants|Infants born to pregnant women who received H1N1 vaccines.
935741|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women who received H1N1 vaccinations.
935742|NCT00992017|O1|Outcome|H1N1 Vaccine|The pregnant women who received the H1N1 vaccinations.
935743|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
935744|NCT00992017|O1|Outcome|Vaccinated Study Participants|Pregnant women who received at least one H1N1 vaccination.
935745|NCT00992017|O1|Outcome|H1N1 Vaccine|Pregnant women enrolled in the study.
935746|NCT00992017|E1|Reported Event|H1N1 Vaccine|Pregnant women received two doses of H1N1 vaccine administered 21 days apart. Each dose consisted of two 15-microgram intramuscular injections.
935747|NCT00991952|B3|Baseline|Total|Total of all reporting groups
935748|NCT00991952|B2|Baseline|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
935947|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily in any intervention period.
935749|NCT00991952|B1|Baseline|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
935750|NCT00991952|P2|Participant Flow|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
935751|NCT00991952|P1|Participant Flow|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
935752|NCT00991952|O2|Outcome|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
935753|NCT00991952|O1|Outcome|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
935754|NCT00991952|E2|Reported Event|Irinotecan Hydrochloride|Patients receive irinotecan hydrochloride as in Arm A. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8
935755|NCT00991952|E1|Reported Event|Irinotecan Hydrochloride and Alvocidib|Patients receive irinotecan hydrochloride IV over 30 minutes and alvocidib IV over 1 hour on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Irinotecan: 100 mg/m2 IV over 30 min on days 1 and 8 followed 7 hours later by Flavopiridol 60 mg/m2 IV over 1 hr on days 1 and 8
935756|NCT00991939|B3|Baseline|Total|Total of all reporting groups
935757|NCT00991939|B2|Baseline|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935758|NCT00991939|B1|Baseline|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935759|NCT00991939|P2|Participant Flow|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935760|NCT00991939|P1|Participant Flow|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935761|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935994|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935762|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935763|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935764|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935765|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935766|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935767|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935768|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935769|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935770|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935771|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935772|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935773|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935774|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935775|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935776|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935794|NCT00991809|P2|Participant Flow|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
935777|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935778|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935779|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935780|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935781|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935782|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935783|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935784|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935785|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935786|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935787|NCT00991939|O2|Outcome|Standard Prednisone Therapy|Prednisone : Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935788|NCT00991939|O1|Outcome|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized : The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935789|NCT00991939|E2|Reported Event|Standard Prednisone Therapy|Prednisone: Prednisone will be administered to study patients at a dose of 60 mg/day for patients less than 60 kg and 80 mg/day for patients > 60 kg for 21 days. The following schedule for tapering of prednisone will be used: after three weeks of treatment at either 60 mg/day (for patients < 60 kg) or 80 mg/day (for patients ≥ 60 kg), the dose will be reduced to 40 mg/day for 1 week, then 20 mg/day for 1 week, then 10 mg/day for 1 week, then 5 mg/day for 1 week and then stopped. Placebo capsules will be added as necessary during the treatment phase of the study, to maintain blinding.
935790|NCT00991939|E1|Reported Event|High Dose Pulse Dexamethasone|Dexamethasone USP Micronized: The dose for dexamethasone is 30 mg/day for patients < 60 kg and 40 mg/day for patients > 60 kg. The patient will be dosed on days 1-4, 15-18 and 29-32. On the remaining days during the treatment phase of the study, the patient will receive placebo capsules.
935791|NCT00991809|B3|Baseline|Total|Total of all reporting groups
935792|NCT00991809|B2|Baseline|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
935793|NCT00991809|B1|Baseline|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
935795|NCT00991809|P1|Participant Flow|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
935796|NCT00991809|O2|Outcome|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
935797|NCT00991809|O1|Outcome|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
935798|NCT00991809|E2|Reported Event|Diphenhydramine|"Subjects will receive a series of acute diphenhydramine administrations each session (25 mg IM per session), with sessions spaced at 3-4 day intervals.~Diphenhydramine : 25 mg IM"
935799|NCT00991809|E1|Reported Event|Alfentanil|"These subjects will receive a series of acute alfentanil administrations each session (15 mcg/kg IM per session), with sessions spaced at 3-4 day intervals.~Alfentanil : 15 mcg/kg IM"
935800|NCT00991510|B3|Baseline|Total|Total of all reporting groups
935801|NCT00991510|B2|Baseline|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
935802|NCT00991510|B1|Baseline|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
935948|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935949|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935803|NCT00991510|P2|Participant Flow|Test/Reference/Reference|"The test product was Myfenax® and the reference product was CellCept®. In period I, participants received Myfenax on Days 1-14. In period II, participants crossed-over to receive CellCept on Days 15-28. In period III, participants received CellCept until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
935804|NCT00991510|P1|Participant Flow|Reference/Test/Test|"The reference product was CellCept® and test product was Myfenax®. In period I, participants received CellCept on Days 1-14. In period II, participants crossed-over to receive Myfenax on Days 15-28. In period III, participants received Myfenax until the end of the study (Days 29-112).~Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening."
935805|NCT00991510|O3|Outcome|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
935806|NCT00991510|O2|Outcome|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935807|NCT00991510|O1|Outcome|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935808|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935809|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935810|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935811|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935812|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935813|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935814|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935815|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935816|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935817|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935818|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935819|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935820|NCT00991510|O2|Outcome|Myfenax|Timeframes in periods I and II when participants took Myfenax in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935821|NCT00991510|O1|Outcome|CellCept|Timeframes in periods I and II when participants took CellCept in this cross-over study. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935822|NCT00991510|E3|Reported Event|Overall|Participant experience overall, i.e. all treatment experiences while on study are included
935823|NCT00991510|E2|Reported Event|Myfenax|Participants experience while on Myfenax during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935977|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935824|NCT00991510|E1|Reported Event|CellCept|Participants experience while on CellCept during any of the three study periods. Doses of mycophenolate mofetil were at least 500 mg twice daily, morning and evening.
935825|NCT00991458|B4|Baseline|Total|Total of all reporting groups
935826|NCT00991458|B3|Baseline|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935827|NCT00991458|B2|Baseline|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935828|NCT00991458|B1|Baseline|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935829|NCT00991458|P3|Participant Flow|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935830|NCT00991458|P2|Participant Flow|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935831|NCT00991458|P1|Participant Flow|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935832|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935833|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935950|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935834|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935835|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935836|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935837|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935838|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935839|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935840|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935841|NCT00991458|O3|Outcome|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935842|NCT00991458|O2|Outcome|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935843|NCT00991458|O1|Outcome|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935844|NCT00991458|E3|Reported Event|Placebo (Vehicle for Cyclosporine)|Placebo eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935845|NCT00991458|E2|Reported Event|Cyclosporine 0.005% Eye Drops|Cyclosporine 0.005% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935846|NCT00991458|E1|Reported Event|Cyclosporine 0.010% Eye Drops|Cyclosporine 0.010% eye drops administered as 1 drop to each eye twice daily (morning and evening) for at least 2 weeks prior to LASIK surgery and up to 7 months post-LASIK surgery.
935847|NCT00991341|B3|Baseline|Total|Total of all reporting groups
935848|NCT00991341|B2|Baseline|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935849|NCT00991341|B1|Baseline|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935850|NCT00991341|P2|Participant Flow|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935851|NCT00991341|P1|Participant Flow|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935978|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935979|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935852|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935853|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935854|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935855|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935856|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935857|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935858|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935859|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935860|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935861|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935862|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935863|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935864|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935865|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935866|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935867|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935868|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935869|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935870|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935871|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935872|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935980|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935981|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935873|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935874|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935875|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935876|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935877|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935878|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935879|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935880|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935951|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935952|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935881|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935882|NCT00991341|O2|Outcome|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935883|NCT00991341|O1|Outcome|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935884|NCT00991341|E2|Reported Event|Longer-storage Red Blood Cell Units|"Red blood cell units stored >= 21 days~Red blood cell units stored >= 21 days: Pre-storage leukoreduced red blood cell units stored >=21 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935885|NCT00991341|E1|Reported Event|Shorter-storage Red Blood Cell Units|"Red blood cell units stored <= 10 days~Red blood cell units stored <= 10 days: Pre-storage leukoreduced red blood cell units stored <=10 days at time of transfusion. Can be AS1, AS3, or AS5. Frozen, deglycerolized, washed, and volume-reduced products are protocol violations."
935886|NCT00991302|B3|Baseline|Total|Total of all reporting groups
935887|NCT00991302|B2|Baseline|Standard Care|Participants received standard care.
935888|NCT00991302|B1|Baseline|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935889|NCT00991302|P2|Participant Flow|Standard Care|Participants received standard care.
935890|NCT00991302|P1|Participant Flow|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935891|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
935892|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935893|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
935894|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935895|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
935896|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935897|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
935982|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935983|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935898|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935899|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
935900|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935901|NCT00991302|O2|Outcome|Standard Care|Participants received standard care.
935902|NCT00991302|O1|Outcome|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935903|NCT00991302|E2|Reported Event|Standard Care|Participants received standard care.
935904|NCT00991302|E1|Reported Event|CAP-IT|"Participants received the modified CAP-IT adherence intervention in addition to standard care.~Modified client adherence profiling and intervention tailoring (CAP-IT): Interventions designed to improve medication adherence, modified to specifically target people first starting highly active antiretroviral therapy (HAART)"
935905|NCT00991289|B1|Baseline|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935906|NCT00991289|P1|Participant Flow|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935907|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935908|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
951286|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
935909|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935910|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935911|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935912|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935913|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935914|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935915|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935916|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935917|NCT00991289|O1|Outcome|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935918|NCT00991289|E1|Reported Event|NTZ/PEG/RBV|Participants received nitazoxanide (NTZ) alone for 4 weeks followed by up to 48 weeks of NTZ with pegylated interferon (PEG) and ribavirin (RBV). Participants who did not achieve early virologic response (EVR) at Week 16 or had detectable hepatitis C virus (HCV) viral load at Week 28 discontinued treatment.
935919|NCT00991276|B7|Baseline|Total|Total of all reporting groups
935984|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935985|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935986|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935987|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935988|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935920|NCT00991276|B6|Baseline|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935921|NCT00991276|B5|Baseline|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935922|NCT00991276|B4|Baseline|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935923|NCT00991276|B3|Baseline|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935924|NCT00991276|B2|Baseline|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935925|NCT00991276|B1|Baseline|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935926|NCT00991276|P6|Participant Flow|Pramipexole 0.5 mg Then Placebo Then Pregabalin 300 mg|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935927|NCT00991276|P5|Participant Flow|Placebo Then Pregabalin 300 mg Then Pramipexole 0.5 mg|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935928|NCT00991276|P4|Participant Flow|Pregabalin 300 mg Then Pramipexole 0.5 mg Then Placebo|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935989|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935990|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935991|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935929|NCT00991276|P3|Participant Flow|Pregabalin 300 mg Then Placebo Then Pramipexole 0.5 mg|PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in first intervention period then PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in second intervention period and PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935930|NCT00991276|P2|Participant Flow|Pramipexole 0.5 mg Then Pregabalin 300 mg Then Placebo|PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in first intervention period then PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in second intervention period and PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935931|NCT00991276|P1|Participant Flow|Placebo Then Pramipexole 0.5 mg Then Pregabalin 300 mg|Placebo (PBO) capsule matched to pramipexole (PPX) 0.5 milligram (mg) once daily or pregabalin (PGB) 300 mg once daily (matching placebo escalation and tapering scheme was followed) in first intervention period then PPX capsule 0.5 mg once daily following a 2 week up escalation, Day 1-5: 0.125 mg; Day 6-10: 0.25 mg and Day 11 onwards: 0.5 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 0.25 mg and Day 4-6: 0.125 mg) in second intervention period and PGB capsule 300 mg once daily following a 2 week up escalation, Day 1-5: 75 mg; Day 6-10: 150 mg and Day 11 onwards: 300 mg fixed dose for 19 days followed by tapering schedule (Day 1-3: 150 mg and Day 4-6: 75 mg) in third intervention period. A PBO wash-out period of 7 days was maintained between each period.
935932|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935933|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935934|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935935|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935936|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935937|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935938|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935939|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935940|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935941|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935942|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935943|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935944|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935945|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935953|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935954|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935955|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935956|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935957|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935958|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935959|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935960|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935961|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935962|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935963|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935964|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935965|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935966|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935967|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935968|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935969|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935970|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935971|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935972|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935973|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935974|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935975|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935976|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
951416|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
935995|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935996|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
935997|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
935998|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
935999|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936000|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936001|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936002|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936003|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936004|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936005|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936006|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936007|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936008|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936009|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936010|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936011|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936012|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936013|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936014|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936015|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936016|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936017|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936018|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936019|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936020|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936021|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936022|NCT00991276|O3|Outcome|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily in any intervention period.
936023|NCT00991276|O2|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936024|NCT00991276|O1|Outcome|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936025|NCT00991276|E3|Reported Event|Placebo|PBO capsule matched to PPX 0.5 mg once daily or PGB 300 mg once daily (matching placebo escalation and tapering scheme was followed) in any of the intervention period.
936026|NCT00991276|E2|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily in any intervention period.
936027|NCT00991276|E1|Reported Event|Pregabalin 300 mg|PGB capsule 300 mg once daily in any intervention period.
936028|NCT00991185|B1|Baseline|Vancomycin|children that received vancomycin per standard of care
936029|NCT00991185|P1|Participant Flow|Vancomycin|children that received vancomycin per standard of care
936030|NCT00991185|O1|Outcome|Vancomycin|children that received vancomycin per standard of care
936031|NCT00991185|E1|Reported Event|Vancomycin|children that received vancomycin per standard of care
936032|NCT00991081|B3|Baseline|Total|Total of all reporting groups
936033|NCT00991081|B2|Baseline|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
936034|NCT00991081|B1|Baseline|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
936035|NCT00991081|P3|Participant Flow|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone and either bupropion or nicotine replacement patch
936036|NCT00991081|P2|Participant Flow|Standard Treatment|Received behavioral counseling by telephone and either bupropion or nicotine replacement patch
936037|NCT00991081|P1|Participant Flow|Formative Interviews|"Phase 1 involved formative research to develop and refine a patient-centered, theoretically grounded behavioral intervention for delivering genetically-tailored smoking cessation treatment. We convened a panel of doctorate level experts (n = 10) in pharmacogenetics; smoking cessation treatment; ethical, legal and social implications of genetics research; genetic literacy; patient-clinician communications; and mixed-methods research to guide development of the pharmacogenetic treatment, GF and evaluation.~Next, smokers were asked about their familiarity with genetic concepts (e.g., DNA, genes), understanding of the roles genes play in smoking behavior and treatment response, reaction to the concept of genetically-tailoring pharmacotherapy, familiarity with the Genetic Information Nondiscrimination Act, concerns about privacy of genetic information, and interest in genetically-tailored treatment. Interviews were continued until response saturation was achieved (n = 10)."
936038|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936039|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936040|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936041|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936042|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936043|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936044|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936045|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936046|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936047|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936048|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936049|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936091|NCT00990821|P11|Participant Flow|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
936050|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936051|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936052|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936053|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936054|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936055|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936056|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936057|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936058|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936059|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936060|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936061|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936062|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936063|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936064|NCT00991081|O2|Outcome|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936065|NCT00991081|O1|Outcome|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936066|NCT00991081|E2|Reported Event|Genetic Feedback Plus Standard Treatment|Received genetic feedback regarding treatment selection in addition to behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936067|NCT00991081|E1|Reported Event|Standard Treatment|Received behavioral counseling by telephone, combined with either bupropion or nicotine replacement patch
936068|NCT00990964|B1|Baseline|Attain Family Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
936069|NCT00990964|P1|Participant Flow|Attain Family Left Heart Lead|Subjects who underwent an Attain Family lead implant after either an Attain Family catheter attempt or any catheter model attempt
936070|NCT00990964|O1|Outcome|Attain Family Lead Attempt, Any Catheter|Subjects who were attempted with Attain Family delivery catheters or Attain Family left-heart leads were included in this analysis.
936071|NCT00990964|O1|Outcome|Attain Family Lead and Catheter Attempt|Subjects who were attempted with an Attain Family left-heart lead after successful coronary sinus (CS) cannulation with an Attain Family catheter were included in this analysis as well as subjects who had unsuccessful CS cannulation with an Attain Family delivery catheter.
936072|NCT00990964|E1|Reported Event|Attain Family Lead|All new and/or worsening adverse events related to the left-heart leads and left-heart lead delivery catheters were collected through the 3 month visit. Event collection started once the subject enrolled in the study and underwent a left-heart lead implant attempt.
936073|NCT00990821|B15|Baseline|Total|Total of all reporting groups
936074|NCT00990821|B14|Baseline|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
936075|NCT00990821|B13|Baseline|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
936133|NCT00990704|P2|Participant Flow|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936076|NCT00990821|B12|Baseline|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
936077|NCT00990821|B11|Baseline|Part V, Treatment Sequence 3|115 mg MK-0517 (PS80) → 125 mg aprepitant → 100 mg MK-0517 (PS80)
936078|NCT00990821|B10|Baseline|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
936079|NCT00990821|B9|Baseline|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
936080|NCT00990821|B8|Baseline|Part IV|40 mg MK-0517 (non-PS80 formulation)
936081|NCT00990821|B7|Baseline|Part III, Panel 2|40 mg MK-0517 (non-PS80)
936082|NCT00990821|B6|Baseline|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
936083|NCT00990821|B5|Baseline|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
936084|NCT00990821|B4|Baseline|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
936085|NCT00990821|B3|Baseline|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
936086|NCT00990821|B2|Baseline|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
936087|NCT00990821|B1|Baseline|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
936088|NCT00990821|P14|Participant Flow|Part V, Treatment Sequence 6|115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80) → 125 mg aprepitant
936089|NCT00990821|P13|Participant Flow|Part V, Treatment Sequence 5|100 mg MK-0517 (PS80) → 125 mg aprepitant → 115 mg MK-0517 (PS80)
936090|NCT00990821|P12|Participant Flow|Part V, Treatment Sequence 4|125 mg aprepitant → 115 mg MK-0517 (PS80) → 100 mg MK-0517 (PS80)
936092|NCT00990821|P10|Participant Flow|Part V, Treatment Sequence 2|100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80) → 125 mg aprepitant
936093|NCT00990821|P9|Participant Flow|Part V, Treatment Sequence 1|125 mg aprepitant → 100 mg MK-0517 (PS80) → 115 mg MK-0517 (PS80 formulation)
936094|NCT00990821|P8|Participant Flow|Part IV|40 mg MK-0517 (non-PS80 formulation)
936095|NCT00990821|P7|Participant Flow|Part III, Panel 2|40 mg MK-0517 (non-PS80)
936096|NCT00990821|P6|Participant Flow|Part III, Panel 1, Treatment Sequence 2|40 mg MK-0517 (non-PS80) → 125 mg aprepitant
936097|NCT00990821|P5|Participant Flow|Part III, Panel 1, Treatment Sequence 1|125 mg aprepitant → 90 mg MK-0517 (PS80)
936098|NCT00990821|P4|Participant Flow|Part II|2 mg midazolam → 100 mg MK-0517 (PS80) + 2 mg midazolam
936099|NCT00990821|P3|Participant Flow|Part I, Panel C|40 mg MK-0517 (non-PS80) or placebo → 40 mg aprepitant
936100|NCT00990821|P2|Participant Flow|Part I, Panel B|100 mg MK-0517 (PS80 formulation [PS80]) or placebo → 150 mg MK-0517 (PS80) or placebo → 125 mg aprepitant
936101|NCT00990821|P1|Participant Flow|Part I, Panel A|100 mg MK-0517 (non-polysorbate 80 formulation [non-PS80]) or placebo → 150 mg MK-0517 (non-PS80) or placebo → 125 mg aprepitant
936102|NCT00990821|O3|Outcome|MK-0517 (115 mg)|115 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
936103|NCT00990821|O2|Outcome|MK-0517 (100 mg)|100 mg of MK0517 (PS80 formulation) as an IV (intravenous) administered over 15 minutes
936104|NCT00990821|O1|Outcome|Aprepitant (125 mg)|A single oral dose with an Aprepitant capsule
936105|NCT00990821|E12|Reported Event|2 mg Midazolam|Midazolam administered as a single oral solution
936106|NCT00990821|E11|Reported Event|125 mg Aprepitant|Aprepitant administered as a single oral capsule
936107|NCT00990821|E10|Reported Event|40 mg Aprepitant|Aprepitant administered by a single oral capsule
936108|NCT00990821|E9|Reported Event|Placebo|Placebo matching MK-0517 (PS80 or non-PS80)
936109|NCT00990821|E8|Reported Event|150 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
936110|NCT00990821|E7|Reported Event|100 mg MK-0517 (Non-PS80)|MK-0517, PS80 formulation, administered with a single IV administration
936111|NCT00990821|E6|Reported Event|40 mg MK-0517 (Non-PS80)|MK-0517, non-PS80 formulation, administered with a single IV administration
936112|NCT00990821|E5|Reported Event|150 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
936113|NCT00990821|E4|Reported Event|115 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
936114|NCT00990821|E3|Reported Event|100 mg MK-0517 (PS80) + 2 mg Midazolam|PS80 formulation, administered with a single IV administration and a single oral administration of midazolam
936115|NCT00990821|E2|Reported Event|100 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
936116|NCT00990821|E1|Reported Event|90 mg MK-0517 (PS80)|MK-0517, PS80 formulation, administered with a single IV administration
936117|NCT00990769|B3|Baseline|Total|Total of all reporting groups
936118|NCT00990769|B2|Baseline|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
936119|NCT00990769|B1|Baseline|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
936120|NCT00990769|P2|Participant Flow|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
936121|NCT00990769|P1|Participant Flow|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
936122|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
936123|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
936124|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
936125|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
936126|NCT00990769|O2|Outcome|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
936127|NCT00990769|O1|Outcome|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
936128|NCT00990769|E2|Reported Event|Low-normal BIS|Depth of anesthesia is titrated to a BIS level of 40-45
936129|NCT00990769|E1|Reported Event|High-normal BIS|Depth of anesthesia is titrated to a BIS level of 55-60
936130|NCT00990704|B3|Baseline|Total|Total of all reporting groups
936131|NCT00990704|B2|Baseline|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936132|NCT00990704|B1|Baseline|Paricalcitol|2 mcg with incremental of 1 mcg
936137|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936138|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
936139|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936140|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
936141|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936142|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
936143|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936144|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
936145|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936146|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
936147|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936148|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
936149|NCT00990704|O2|Outcome|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936150|NCT00990704|O1|Outcome|Paricalcitol|2 mcg with incremental of 1 mcg
936151|NCT00990704|E2|Reported Event|Maxacalcitol|5 or 10 mcg with incremental of 2.5 mcg
936152|NCT00990704|E1|Reported Event|Paricalcitol|2 mcg with incremental of 1 mcg
936330|NCT00989768|O2|Outcome|Botox ® 2U|Two units of Botox® was administered to the other side of the frontal region.
936153|NCT00990652|B1|Baseline|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
936154|NCT00990652|P1|Participant Flow|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
936155|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
936156|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
936157|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
936158|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
936159|NCT00990652|O1|Outcome|Bortezomib + Temozolomide|Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery (approximately 14 days later), patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 4 weeks or 28 days). Temozolomide (75 mg/m^2) is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib (1.3 mg/m^2) is given intravenously (IV) on days 7 and 21 of each cycle. Patients continue to receive cycles of treatment until disease progression, development of unacceptable toxicity, or up to a maximum of 24 months.
936184|NCT00990509|E1|Reported Event|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936185|NCT00990340|B3|Baseline|Total|Total of all reporting groups
937302|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
936160|NCT00990652|E1|Reported Event|Bortezomib + Temozolomide|"Patients receive an injection of bortezomib 1.7mg/m^2 on days 1, 4 and 8. Patients then undergo their standard of care surgery on day 8 or 9 to remove the tumor. Once recovered from surgery, patients receive combination treatment with temozolomide and bortezomib in periods called cycles (1 cycle = 28 days). Temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle, and bortezomib injections are given on days 7 and 21 of each cycle.~Bortezomib: Before surgery, an injection of bortezomib is given on days 1, 4, and 8. After surgery, bortezomib is given on days 7 and 21 of each cycle (1 cycle = 28 days).~Temozolomide: After surgery, temozolomide is taken by mouth on days 1-7 and 14-21 of each cycle (1 cycle = 28 days)."
936161|NCT00990561|B3|Baseline|Total|Total of all reporting groups
936162|NCT00990561|B2|Baseline|Ultravate Once a Day|Ultravate ointment applied once daily
936163|NCT00990561|B1|Baseline|Ultravate Twice a Day|
936164|NCT00990561|P4|Participant Flow|No Treatment|
936165|NCT00990561|P3|Participant Flow|Lac-Hydrin Topically Twice a Day|
936166|NCT00990561|P2|Participant Flow|Once Daily Topical Ultravate Ointment + LacHydrin Lotion|
936167|NCT00990561|P1|Participant Flow|Twice Daily Topical Ultravate Ointment + LacHyrin Twice Daily|
936168|NCT00990561|O2|Outcome|Ultravate 0.05% Ointment Once Daily|Ultravate one daily to affected area.
936169|NCT00990561|O1|Outcome|Ultravate 0.05% Ointment Twice Daily|Ultravate twice daily to affected area.
936170|NCT00990561|E2|Reported Event|Ultravate Once a Day|Ultravate ointment applied once daily
936171|NCT00990561|E1|Reported Event|Ultravate Twice a Day|
936172|NCT00990509|B3|Baseline|Total|Total of all reporting groups
936196|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
936197|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
951287|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
936173|NCT00990509|B2|Baseline|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936174|NCT00990509|B1|Baseline|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936175|NCT00990509|P2|Participant Flow|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936176|NCT00990509|P1|Participant Flow|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936177|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936178|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936179|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936180|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936181|NCT00990509|O2|Outcome|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936182|NCT00990509|O1|Outcome|Albumin|"Albumin: Three (3) daily IV infusions of 1.25 g/kg Albumin (25%) on Days 1-3 following enrollment.~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936183|NCT00990509|E2|Reported Event|Placebo|"Placebo: Three (3) daily IV infusions of 1.25 g/kg Saline solution on Days 1-3 following enrollment~Brain MRI with and without contrast: All subjects will receive 3 brain MRI studies, regardless of if they are randomized into Albumin or Placebo condition.~MRIs will be with and without contrast will be performed at:~Baseline~48 hours after enrollment(approximately Day 3)~96 hours after drug treatment begins (approximately Day 5)"
936186|NCT00990340|B2|Baseline|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
936187|NCT00990340|B1|Baseline|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
936188|NCT00990340|P2|Participant Flow|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
936189|NCT00990340|P1|Participant Flow|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
936190|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
936191|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
936192|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
936193|NCT00990340|O1|Outcome|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
936194|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
936195|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
936233|NCT00989989|P2|Participant Flow|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936198|NCT00990340|O2|Outcome|TevTropin® by Needle-syringe|Needle-syringe injection method for 14 days before cross-over to other arm for 14 days
936199|NCT00990340|O1|Outcome|TevTropin® Needle-free|Needle-free injection method (T-jet®)for 14 days before cross-over to other arm for 14 days
936200|NCT00990340|E2|Reported Event|TevTropin® by Needle-syringe Followed byTevTropin® Needle-free|needle-syringe injection method for 14 days before cross-over to other arm
936201|NCT00990340|E1|Reported Event|TevTropin® Needle-free Followed by TevTropin® Syringe|needle-free injection method (T-jet®)for 14 days before cross-over to other arm
936202|NCT00990184|B1|Baseline|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
936203|NCT00990184|P1|Participant Flow|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
936204|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline (end of two week placebo run in period)
936205|NCT00990184|O1|Outcome|Colesevelam 3.75 g Daily|Medication used to treat people with increased cholesterol levels
936206|NCT00990184|O1|Outcome|Colesevelam|Effect of colesevelam treatment compared to baseline
936207|NCT00990184|E1|Reported Event|Colesevelam Hydrochloride|People with IGT will take 2 weeks of placebo and then 8 weeks of study drug
936208|NCT00990106|B3|Baseline|Total|Total of all reporting groups
936209|NCT00990106|B2|Baseline|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
936210|NCT00990106|B1|Baseline|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
936211|NCT00990106|P2|Participant Flow|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
936212|NCT00990106|P1|Participant Flow|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
936213|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
936214|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
936215|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
936216|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
936217|NCT00990106|O2|Outcome|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
936218|NCT00990106|O1|Outcome|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
936219|NCT00990106|E2|Reported Event|Placebo|placebo: placebo titrated in the same manner as prazosin arm.
936318|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936220|NCT00990106|E1|Reported Event|Prazosin Hydrochloride|"prazosin hydrochloride: Subject will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) then titrating the dose upward gradually."
936221|NCT00990093|B1|Baseline|Entire Study Population|
936222|NCT00990093|P2|Participant Flow|B: First Standard Catheter Then Test Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
936223|NCT00990093|P1|Participant Flow|A: First Test Catheter Then Standard Catheter|Test catheter is a CH 12 hydrophilic coated intermittent catheter
936224|NCT00990093|O2|Outcome|Standard Catheter|SpeediCath Catheter
936225|NCT00990093|O1|Outcome|Test Catheter|SpeediCath Compact Male Catheter
936226|NCT00990093|E2|Reported Event|Standard Catheter|SpeediCath, CH 12 hydrophilic coated intermittent catheter
936227|NCT00990093|E1|Reported Event|Test Catheter|SpeediCath Compact Male
936228|NCT00989989|B4|Baseline|Total|Total of all reporting groups
936229|NCT00989989|B3|Baseline|Laser Control|Active laser treatment plus sham intravitreal injections.
936230|NCT00989989|B2|Baseline|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936231|NCT00989989|B1|Baseline|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936232|NCT00989989|P3|Participant Flow|Laser Control|Active laser treatment plus sham intravitreal injections.
936234|NCT00989989|P1|Participant Flow|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936235|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936236|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936237|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936238|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936239|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936240|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936241|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936242|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936243|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936244|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936245|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936246|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936247|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936248|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936249|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936250|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936251|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936252|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936253|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936254|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936255|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936256|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936257|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936258|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936259|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936260|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936261|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936262|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936263|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936264|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936265|NCT00989989|O3|Outcome|Laser Control|Active laser treatment plus sham intravitreal injections.
936266|NCT00989989|O2|Outcome|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936267|NCT00989989|O1|Outcome|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936268|NCT00989989|E3|Reported Event|Laser Control|Active laser treatment plus sham intravitreal injections.
936269|NCT00989989|E2|Reported Event|Adjunctive Treatment|Adjunctive administration of ranibizumab 0.5 mg intravitreal injections and active laser.
936270|NCT00989989|E1|Reported Event|Monotherapy Treatment|Monotherapy ranibizumab 0.5 mg intravitreal injections plus sham laser.
936271|NCT00989950|B5|Baseline|Total|Total of all reporting groups
951417|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
936272|NCT00989950|B4|Baseline|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936273|NCT00989950|B3|Baseline|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936274|NCT00989950|B2|Baseline|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936275|NCT00989950|B1|Baseline|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936276|NCT00989950|P4|Participant Flow|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936277|NCT00989950|P3|Participant Flow|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936278|NCT00989950|P2|Participant Flow|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936279|NCT00989950|P1|Participant Flow|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936280|NCT00989950|O4|Outcome|12 hr Wear|Result for all patients when patch worn for 12 hrs/day
936281|NCT00989950|O3|Outcome|11 hr Wear|Result for all patients when patch worn for 11 hrs/day
936282|NCT00989950|O2|Outcome|10 hr Wear|Result for all patients when patch worn for 10 hrs/day
936284|NCT00989950|E4|Reported Event|Group Sequence 4|Daytrana 10-30 mg worn 12 hrs, 11 hrs, 10 hrs, then 9 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936285|NCT00989950|E3|Reported Event|Group Sequence 3|Daytrana 10-30 mg worn 9 hrs, 10 hrs, 11 hrs, then 12 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936286|NCT00989950|E2|Reported Event|Group Sequence 2|Daytrana 10-30 mg worn 11 hrs, 9 hrs, 12 hrs then 10 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936287|NCT00989950|E1|Reported Event|Group Sequence 1|Daytrana 10-30 mg worn 10 hrs, 12 hrs, 9 hrs then 11 hrs daily each period lasting Monday-Thursday of each week, followed by 12 hr daily wear on Fri-Sun
936288|NCT00989911|B1|Baseline|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
936289|NCT00989911|P1|Participant Flow|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
936290|NCT00989911|O1|Outcome|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
936291|NCT00989911|E1|Reported Event|Bosentan|Bosentan: Bosentan 62.5 mg tablet taken orally twice daily for one month, followed by Bosentan 125 mg tablet taken orally twice daily for three months.
936292|NCT00989833|B4|Baseline|Total|Total of all reporting groups
936293|NCT00989833|B3|Baseline|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936294|NCT00989833|B2|Baseline|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936295|NCT00989833|B1|Baseline|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936296|NCT00989833|P3|Participant Flow|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936297|NCT00989833|P2|Participant Flow|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936298|NCT00989833|P1|Participant Flow|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936299|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936300|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936301|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936302|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936303|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936304|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936305|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936306|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936307|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936308|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936309|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936310|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936311|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936312|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936313|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936314|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936315|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936316|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936317|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936319|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936320|NCT00989833|O3|Outcome|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936321|NCT00989833|O2|Outcome|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936322|NCT00989833|O1|Outcome|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936323|NCT00989833|E3|Reported Event|Budesonide/Formoterol|Placebo budesonide once daily and budesonide/formoterol before exercise and as needed
936324|NCT00989833|E2|Reported Event|Terbutaline|Placebo budesonide once daily and terbutaline before exercise and as needed
936325|NCT00989833|E1|Reported Event|Budesonide/Terbutaline|Budesonide once daily and terbutaline before exercise and as needed
936326|NCT00989768|B1|Baseline|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
936327|NCT00989768|P1|Participant Flow|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
936328|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered two units to the other side of frontal region
936329|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
936331|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
936332|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
936333|NCT00989768|O1|Outcome|Dysport® 5U|Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
936334|NCT00989768|O2|Outcome|Botox® 2U|Two units of Botox® was administered to the other side of the frontal region.
936335|NCT00989768|O1|Outcome|Dysport® 5U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region.
936336|NCT00989768|E1|Reported Event|Dysport® 5U/ Botox® 2U|Botulinum toxin A (Dysport®) 5 U Subjects have received one injection of five units of botulinum toxin , called Dysport® on one side in the frontal region, that the other brand Botox® was administered two units to the other side of the frontal region.
936337|NCT00989664|B1|Baseline|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936338|NCT00989664|P1|Participant Flow|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936339|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936340|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936341|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936360|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
936342|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936343|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936353|NCT00989664|O2|Outcome|LQCR|Participants treated with at least two chemotherapy regimens before enrolling in study BEX104504
936405|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936406|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
951288|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
936344|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936345|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936346|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936347|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936348|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936349|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936380|NCT00989586|E1|Reported Event|All Patients From Phase I and Phase II|Toxicities were graded according to NCI Common Toxicity Criteria for Adverse Events version 3.0 and classified as either unrelated, unlikely, possibly, probably or definitely related to study treatment.
936381|NCT00989235|B3|Baseline|Total|Total of all reporting groups
936350|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936351|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936352|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936511|NCT00989014|O4|Outcome|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
936354|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936355|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936356|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936357|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936358|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936359|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936361|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936362|NCT00989664|O2|Outcome|LQCR|Participants previously treated with at least two chemotherapy regimes before enrolling in Study BEX104504
936363|NCT00989664|O1|Outcome|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936396|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936397|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936398|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936399|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936364|NCT00989664|E1|Reported Event|TST and I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) immediately followed by I 131 TST (35 mg of TST, of which 1-2 mg was labelled with 5 millicurie [mCi] of I 131) IV. The therapeutic dose (TD) consisted of 450 mg of TST IV, immediately followed by a participant-specific dose of I 131 TST (35 mg of TST labelled with I 131 to administer 75 centigray [cGy] or 65 cGy). The TD was administered 7-14 days after the DD. Participants who had completed at least 2 years of follow up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104526) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
936365|NCT00989586|B3|Baseline|Total|Total of all reporting groups
936366|NCT00989586|B2|Baseline|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
936367|NCT00989586|B1|Baseline|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
936368|NCT00989586|P2|Participant Flow|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
936369|NCT00989586|P1|Participant Flow|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
936382|NCT00989235|B2|Baseline|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
937303|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
936370|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
936371|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
936372|NCT00989586|O1|Outcome|Patients Dosed at 20mg/kg|First dose milatuzumab pharmacokinetics for patients doses at 20 mg/kg
936373|NCT00989586|O2|Outcome|Phase II|"Patients will receive veltuzumab IV weekly for 4 doses and milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy. Patients may continue on therapy to receive extended induction therapy provided they do not experience significant toxicity or rapid disease progression during the initial 4 week induction.~veltuzumab and milatuzumab: Patient will receive veltuzumab and milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab on day 1 and milatuzumab on day 2. Starting in week 2, veltuxumab will be given on day 1 and milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with extended induction therapy, consisting of veltuzumab day 1 and milatuzumab day 4 of weeks"
936400|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936401|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936402|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936403|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936404|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
951289|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
936374|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
936375|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
936376|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
936377|NCT00989586|O1|Outcome|All Patients From Phase I and Phase II|"Phase I: patients receive Veltuzumab IV weekly on day 1 for 4 doses and Milatuzumab weekly for total of 4 doses during induction therapy. Induction therapy during week 1 patients receive Veltuzumab alone on day 1 and Milatuzumab alone on day 2 to prevent overlapping infusion reactions. Week 2 Veltuzumab on day 1 and Milatuzumab on day 4.~Phase II: patients receive Veltuzumab IV weekly for 4 doses and Milatuzumab IV weekly on day 2 of week 1 and on day 4 of weeks 2-4 for 4 total doses during induction therapy."
936378|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
936379|NCT00989586|O1|Outcome|Phase I|"Phase I portion of the study, a standard 3+3 dose escalation schema will be followed. Patients will receive veltuzumab IV weekly on day 1 for 4 doses and milatuzumab weekly on for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive veltuzumab alone on day 1 and milatuzumab alone on day 2 to prevent overlapping infusion reactions. Starting week 2, veltuzumab will be given on day 1 and milatuzumab will be given on day 4.~milatuzumab: Patient will receive milatuzumab weekly for 4 total doses during induction therapy. Induction therapy will be defined as the first 4 weeks of study therapy. During week 1 of induction therapy, patients will receive milatuzumab on day 2. Starting in week 2, milatuzumab will be given on day 4. Provided the patient does not experience excessive toxicity or disease progression during induction therapy, the patient may continue treatment with"
936383|NCT00989235|B1|Baseline|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936384|NCT00989235|P2|Participant Flow|Abatacept (5 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 5 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
936385|NCT00989235|P1|Participant Flow|Abatacept (10 mg/kg)|All subjects in the sub-study randomized to receive double-blind abatacept 10 mg/kg. Subjects rescued to open-label treatment received abatacept 10 mg/kg. The length of the sub-study is 1 year. As such, the maximum time the subject is treated collectively in double-blind and open-label treatment is 1 year.
936386|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936387|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936388|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936389|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936390|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936391|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936392|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936393|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936394|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study treated with double-blind abatacept 5 mg/kg
936395|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study treated with double-blind abatacept 10 mg/kg
936407|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936408|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936409|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936410|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936411|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936412|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936413|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936414|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936415|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936416|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936417|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936418|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936419|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936420|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936421|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936422|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936423|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936424|NCT00989235|O2|Outcome|Abatacept (5 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 5 mg/kg
936425|NCT00989235|O1|Outcome|Abatacept (10 mg/kg)|All participants in the sub-study randomized to receive double-blind abatacept 10 mg/kg
936426|NCT00989235|E3|Reported Event|Abatacept 10mg/kg (Open-Label)|
936427|NCT00989235|E2|Reported Event|Abatacept 10mg/kg (ST)|
936428|NCT00989235|E1|Reported Event|Abatacept 5mg/kg (ST)|
936429|NCT00989196|B1|Baseline|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
936430|NCT00989196|P2|Participant Flow|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936431|NCT00989196|P1|Participant Flow|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936432|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
936433|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK dose
936434|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936435|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936436|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
937254|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
936437|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936438|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936439|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936440|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936441|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936442|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936443|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936444|NCT00989196|O2|Outcome|Kogenate First Crossover, Then Treatment|Participants were randomized to receive Kogenate (50 IU/kg) first (14 days), then Human-cl rhFVIII (50 IU/kg bodyweight) second (14 days) in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936445|NCT00989196|O1|Outcome|Human c1 rhFVIII First Crossover, Then Treatment|Participants were randomized to receive Human-cl rhFVIII (50 IU/kg bodyweight) first, then Kogenate FS (50 IU/kg bodyweight)second in the Crossover period. In the Treatment Period, participants received Human-cl rhFVIII (50 IU/kg bodyweight)
936446|NCT00989196|O2|Outcome|Kogenate FS|Kogenate FS 50 IU/kg for PK dose
936447|NCT00989196|O1|Outcome|Human cl rhFVIII|Human-cl rhFVIII 50 IU/kg for PK dose
936448|NCT00989196|E1|Reported Event|Human cl rhFVIII and Kogenate FS|All participants. Human-cl rhFVIII and Kogenate in cross-over design:50 IU/kg for PK period. After the PK period all participants received Human-cl rhFVIII in the treatment period.
936449|NCT00989157|B3|Baseline|Total|Total of all reporting groups
936450|NCT00989157|B2|Baseline|Control|Subjects matched to the bariatric subjects via BMI, age and gender
936451|NCT00989157|B1|Baseline|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
936452|NCT00989157|P2|Participant Flow|Bariatric|One year post surgery
936453|NCT00989157|P1|Participant Flow|Control|Matched to bariatric subject via BMI, age and gender
936454|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
936455|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
936456|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
936457|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
936458|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
936459|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
936460|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender.
936461|NCT00989157|O1|Outcome|Bariatric|Subjects one year post surgery
936462|NCT00989157|O2|Outcome|Control|Subjects matched to the bariatric subjects via BMI, age and gender
936463|NCT00989157|O1|Outcome|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
936464|NCT00989157|E2|Reported Event|Control|Subjects matched to the bariatric subjects via BMI, age and gender
936465|NCT00989157|E1|Reported Event|Bariatric|Subjects 1 year post bariatric surgery 9 to 15 months post-RYGBP
936466|NCT00989092|B3|Baseline|Total|Total of all reporting groups
936467|NCT00989092|B2|Baseline|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936468|NCT00989092|B1|Baseline|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936469|NCT00989092|P2|Participant Flow|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936470|NCT00989092|P1|Participant Flow|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936471|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936472|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936473|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936474|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936512|NCT00989014|O3|Outcome|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
936513|NCT00989014|O2|Outcome|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
936475|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936476|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936477|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936478|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936479|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936480|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936481|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936482|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936483|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936535|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936484|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936485|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936486|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936487|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936488|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936514|NCT00989014|O1|Outcome|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
936489|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936490|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936491|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936492|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936493|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936494|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936495|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936496|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936497|NCT00989092|O2|Outcome|Observation|Participants in the observation group were evaluated once every 2 weeks for the first 12 weeks (test period). No darbepoetin alfa was administered during this period. Darbepoetin alfa could be initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participant's hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL.
936498|NCT00989092|O1|Outcome|Darbepoetin Alfa 3 μg/kg|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at Week 7 (to 5.0 μg/kg once every 2 weeks) or at Week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at Week 7.
936499|NCT00989092|E3|Reported Event|Observation Arm Not Treated|Participants in the observation group who did not receive any darbepoetin alfa treatment.
936500|NCT00989092|E2|Reported Event|Observation Arm Treated|Participants in the observation group who received darbepoetin alfa, initiated at a dose of 3.0 μg/kg once every 2 weeks beginning with the first visit after the test period at which the participants hemoglobin concentration was less than or equal to 11.0 g/dL. The dose of darbepoetin alfa could be increased to 5.0 μg/kg once every 2 weeks after 6 weeks of darbepoetin alfa treatment in participants with a hemoglobin change from baseline of less than 1.0 g/dL. Adverse events for participants in this group could have been reported at any time during the study; and therefore, may have occurred before darbepoetin alfa administration.
936501|NCT00989092|E1|Reported Event|Treatment Arm|Participants in the treatment group received darbepoetin alfa subcutaneously (SC) at a dose of 3.0 μg/kg once every 2 weeks for 21 weeks. The dose of darbepoetin alfa could be increased at week 7 (to 5.0 μg/kg once every 2 weeks) or at week 13 (to 9.0 μg/kg once every 2 weeks) in participants with a hemoglobin change from baseline of less than 1.0 g/dL who dose escalated at week 7.
936502|NCT00989014|B5|Baseline|Total|Total of all reporting groups
936503|NCT00989014|B4|Baseline|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
936504|NCT00989014|B3|Baseline|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
936505|NCT00989014|B2|Baseline|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
936506|NCT00989014|B1|Baseline|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
936507|NCT00989014|P4|Participant Flow|CD07805/47 Vehicle Topical Gel|Vehicle Topical Gel
936508|NCT00989014|P3|Participant Flow|CD07805/47 0.07% Topical Gel|0.07% Topical Gel
936509|NCT00989014|P2|Participant Flow|CD07805/47 0.18% Topical Gel|0.18% Topical Gel
936510|NCT00989014|P1|Participant Flow|CD07805/47 0.5% Topical Gel|0.5% Topical Gel
936520|NCT00988884|B2|Baseline|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936521|NCT00988884|B1|Baseline|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936522|NCT00988884|P2|Participant Flow|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936523|NCT00988884|P1|Participant Flow|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936524|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936525|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936526|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936527|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936528|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936529|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936530|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936531|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936532|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936533|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936534|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
937304|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
936536|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936537|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936538|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936539|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936540|NCT00988884|O2|Outcome|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936541|NCT00988884|O1|Outcome|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936542|NCT00988884|E2|Reported Event|Non-concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm at Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm at Month 1
936615|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936543|NCT00988884|E1|Reported Event|Concomitant Vaccination|V503 given as a 0.5 mL intramuscular injection in the deltoid muscle of the non-dominant arm on Day 1, Month 2, and Month 6, and Menactra™ and Adacel™ each given as a 0.5 mL intramuscular injection in the deltoid muscle of the dominant arm on Day 1
936544|NCT00988832|B1|Baseline|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
936545|NCT00988832|P1|Participant Flow|Infliximab|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
936546|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936547|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936548|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936549|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936550|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936551|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936552|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936553|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936554|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936555|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936556|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936557|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936558|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936559|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936560|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936561|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936562|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936563|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936564|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936565|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936566|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936567|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936568|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936569|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936570|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936571|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936572|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936573|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936574|NCT00988832|O4|Outcome|0-24 Months Post-Infliximab|Data from the first 24 months following participants' first infusions of infliximab
936575|NCT00988832|O3|Outcome|0-18 Months Post-Infliximab|Data from the first 18 months following participants' first infusions of infliximab
936576|NCT00988832|O2|Outcome|0-12 Months Post-Infliximab|Data from the first 12 months following participants' first infusions of infliximab
936577|NCT00988832|O1|Outcome|0-12 Months Pre-Infliximab|Data from the 12 months prior to participants' first infusions of infliximab
936578|NCT00988832|E1|Reported Event|INFLIXIMAB, RECOMBINANT|Infliximab as prescribed by a physician in normal practice for Crohn’s disease: 5 mg/kg or 10 mg/kg infusion as either maintenance or episodic therapy.
936579|NCT00988637|B3|Baseline|Total|Total of all reporting groups
936580|NCT00988637|B2|Baseline|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936581|NCT00988637|B1|Baseline|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936582|NCT00988637|P2|Participant Flow|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936583|NCT00988637|P1|Participant Flow|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936584|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936616|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936585|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936586|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936587|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936588|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936589|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936590|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936591|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936592|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936593|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936594|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936595|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936596|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936597|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936598|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936599|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936600|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936601|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936602|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936603|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936670|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936604|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936605|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936606|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936607|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936608|NCT00988637|O2|Outcome|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936609|NCT00988637|O1|Outcome|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936610|NCT00988637|E2|Reported Event|Clobex® Spray (Morning) and Vectical® Ointment (Evening)|Clobex® Spray, topical, apply once each morning and Vectical® Ointment, topical, apply once each evening for up to 28 days(PM): AM / PM Regimen
936611|NCT00988637|E1|Reported Event|Vectical® Ointment (Weekdays) and Clobex® Spray (Weekends)|Vectical® Ointment, topical, apply twice daily on weekdays and Clobex® Spray, topical, apply twice daily on weekends for up to 28 days: Weekdays / Weekends Regimen
936612|NCT00988533|B1|Baseline|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936613|NCT00988533|P1|Participant Flow|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936614|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
951290|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
936617|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936618|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936619|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936620|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936621|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936622|NCT00988533|O1|Outcome|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936623|NCT00988533|E1|Reported Event|0.5% Ivermectin|Participants received a single application of 0.5% ivermectin on Day 1.
936624|NCT00988429|B4|Baseline|Total|Total of all reporting groups
936625|NCT00988429|B3|Baseline|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
936626|NCT00988429|B2|Baseline|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
936627|NCT00988429|B1|Baseline|Placebo|Matching placebo tablets QD orally
936628|NCT00988429|P3|Participant Flow|1200 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
936629|NCT00988429|P2|Participant Flow|800 mg QD|The study drug was a conventional immediate-release tablet of eslicarbazepine (ESL) and provided as either 400 mg or 800 mg dosage strengths (the 800 mg tablets were not used in North America). The composition was directly proportional between the strengths. The excipients used were standard pharmaceutical excipients of compendial grade, widely used in the pharmaceutical industry. The medication was taken orally.
936630|NCT00988429|P1|Participant Flow|Placebo|Matching placebo tablets QD orally
936631|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
936632|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
936633|NCT00988429|O1|Outcome|Placebo|Matching placebo tablets QD orally
936634|NCT00988429|O3|Outcome|ESL 1200 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
936635|NCT00988429|O2|Outcome|ESL 800 mg QD (ITT Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
936636|NCT00988429|O1|Outcome|Placebo (ITT Population)|Matching placebo tablets QD orally
936637|NCT00988429|E3|Reported Event|ESL 1200 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
936638|NCT00988429|E2|Reported Event|ESL 800 mg QD (Safety Population)|Oral tablets provided as either 400 mg or 800 mg dosage strengths
936639|NCT00988429|E1|Reported Event|Placebo (Safety Population)|Matching placebo tablets QD orally
936640|NCT00988351|B3|Baseline|Total|Total of all reporting groups
936641|NCT00988351|B2|Baseline|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936671|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
951418|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
936642|NCT00988351|B1|Baseline|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936643|NCT00988351|P2|Participant Flow|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936644|NCT00988351|P1|Participant Flow|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936645|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936646|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936647|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936648|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936649|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936650|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936651|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936652|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936653|NCT00988351|O2|Outcome|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936654|NCT00988351|O1|Outcome|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936655|NCT00988351|E2|Reported Event|Auto-Adjusting Positive Airway Pressure|"Following diagnosis of obstructive sleep apnea patients will be have auto-adjusting positive airway pressure treatment without a titration.~Auto-adjusting positive airway pressure treatment: Pressure range 4-18 centimeters of water (cm H2O)"
936656|NCT00988351|E1|Reported Event|PSG CPAP Titration Then CPAP Treatment|"Patients diagnosed with sleep apnea will have a continuous positive airway pressure (CPAP) titration with polysomnography (PSG) followed by continuous positive airway pressure (CPAP) Treatment~Continuous positive airway pressure: continuous positive airway pressure determined by polysomnography titration"
936657|NCT00988325|B4|Baseline|Total|Total of all reporting groups
936658|NCT00988325|B3|Baseline|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936659|NCT00988325|B2|Baseline|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936660|NCT00988325|B1|Baseline|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
936661|NCT00988325|P3|Participant Flow|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days.
936662|NCT00988325|P2|Participant Flow|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936663|NCT00988325|P1|Participant Flow|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
936664|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936665|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936666|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936667|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936668|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936669|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
951419|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
936672|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
936673|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936674|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936675|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936676|NCT00988325|O3|Outcome|Type B|Genotype B was present in 12, 2, and 2 participants of age groups <365 days, 31 to 90 days, and <=30 days, respectively.
936677|NCT00988325|O2|Outcome|Type A H3|Genotype Type A H3 was present in 4 participants and 6 participants of age groups 91 to <365 days and 31 to 90 days, respectively
936678|NCT00988325|O1|Outcome|Type A (H1N1)pdm09|Genotype A (H1N1)pdm09 was present in 21 participants of age group 91 to <365 days, 9 participants of age group 31 to 90 days, and 2 participants of age group <=30 days
936679|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936680|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936681|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
936682|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936683|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936684|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936685|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936686|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936687|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936688|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936689|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936690|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936691|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936692|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936693|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936694|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936695|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936696|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
936697|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936698|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936699|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
936700|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936701|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936702|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936703|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936704|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936705|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
936706|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936707|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936708|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936709|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936710|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936711|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days
936712|NCT00988325|O3|Outcome|Oseltamivir 2 mg/kg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936713|NCT00988325|O2|Outcome|Oseltamivir 2.5 mg/kg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/kg twice a day for 5 days
936714|NCT00988325|O1|Outcome|Oseltamivir 3 mg/kg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 mg/kg twice a day for 5 days.
936788|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936715|NCT00988325|E3|Reported Event|Oseltamivir 2 mg|Participants of age 0 to 30 days received oral suspension of oseltamivir 2 mg/kg twice a day for 5 days
936716|NCT00988325|E2|Reported Event|Oseltamivir 2.5 mg|Participants of age 31 to 90 days received oral suspension of oseltamivir 2.5 mg/ twice a day for 5 days
936717|NCT00988325|E1|Reported Event|Oseltamivir 3 mg|Participants aged 91 to <365 days received oral suspension of oseltamivir 3 milligram (mg)/kilogram (kg) twice a day for 5 days
936718|NCT00988247|B3|Baseline|Total|Total of all reporting groups
936719|NCT00988247|B2|Baseline|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936720|NCT00988247|B1|Baseline|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936721|NCT00988247|P2|Participant Flow|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936722|NCT00988247|P1|Participant Flow|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936723|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936724|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936725|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936726|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936727|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936728|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936729|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936730|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936731|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936732|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936733|NCT00988247|O2|Outcome|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936734|NCT00988247|O1|Outcome|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936735|NCT00988247|E2|Reported Event|Placebo|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily each morning.
936736|NCT00988247|E1|Reported Event|BDP HFA 320 µg/Day|During the 30-week (or 52-week, depending upon investigator site) double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) once daily each morning.
936737|NCT00988221|B4|Baseline|Total|Total of all reporting groups
936738|NCT00988221|B3|Baseline|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936739|NCT00988221|B2|Baseline|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936740|NCT00988221|B1|Baseline|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936741|NCT00988221|P4|Participant Flow|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936742|NCT00988221|P3|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936743|NCT00988221|P2|Participant Flow|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936744|NCT00988221|P1|Participant Flow|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936745|NCT00988221|O3|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936746|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936747|NCT00988221|O1|Outcome|Placebo to Tocilizumab|Patients received placebo to tocilizumab intravenously every 4 weeks.
936748|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
951420|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
936749|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936750|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936751|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936752|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936753|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936754|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936755|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936756|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936757|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936758|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936759|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936760|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936761|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
951291|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
936762|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936763|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936764|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936765|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936766|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936767|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936768|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936769|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936770|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936771|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936772|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936773|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936774|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936775|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936776|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936777|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936778|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936779|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936780|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936781|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936782|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936783|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936784|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936785|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936786|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936787|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936789|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936790|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936791|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936792|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936793|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936794|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936795|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936796|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936797|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936798|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936799|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936800|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936843|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
951292|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
936801|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936802|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936803|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936804|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936805|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936806|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936807|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936808|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936809|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936810|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936811|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936812|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936813|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936814|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936815|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936816|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936817|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936818|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936819|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936820|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936821|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936822|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936823|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936824|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936825|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936826|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936827|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936828|NCT00988221|O5|Outcome|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936829|NCT00988221|O4|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936830|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936831|NCT00988221|O2|Outcome|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936832|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936833|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936834|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936835|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936836|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936837|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936838|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936839|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936840|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936841|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936842|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936844|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936845|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936846|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936847|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936848|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936849|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936850|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936851|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936852|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936853|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936854|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936855|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936856|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936857|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936858|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936859|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936860|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936861|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936862|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936863|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936864|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936865|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936866|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936867|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936868|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936869|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936870|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936871|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936872|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936873|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936874|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936875|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
937255|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
936876|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936877|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936878|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936879|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936880|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936881|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936882|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936883|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936884|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936885|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936886|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936887|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936888|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936889|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936890|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936891|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
951293|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
936892|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936893|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936894|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936895|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936896|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936897|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936898|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936899|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936900|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936901|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936902|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936903|NCT00988221|O4|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936904|NCT00988221|O3|Outcome|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936905|NCT00988221|O2|Outcome|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936906|NCT00988221|O1|Outcome|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936907|NCT00988221|O2|Outcome|Tocilizumab 8 or 10 mg/kg|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936908|NCT00988221|O1|Outcome|Placebo|Patients received placebo to tocilizumab intravenously every 4 weeks.
936909|NCT00988221|E5|Reported Event|All Tocilizumab Patients|Patients received tocilizumab 8 or 10 mg/kg intravenously every 4 weeks.
936910|NCT00988221|E4|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing ≥ 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936911|NCT00988221|E3|Reported Event|Tocilizumab 8 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 8 mg/kg intravenously every 4 weeks.
936912|NCT00988221|E2|Reported Event|Tocilizumab 10 mg/kg to 8 mg/kg in Patients Weighing < 30 kg|Patients weighing < 30 kg at baseline receiving tocilizumab 10 mg/kg whose body weight increased to ≥ 30 kg and ≥ 5 kg over baseline body weight for 3 consecutive visits had the tocilizumab dose reduced to 8 mg/kg.
936913|NCT00988221|E1|Reported Event|Tocilizumab 10 mg/kg in Patients Weighing < 30 kg|Patients received tocilizumab 10 mg/kg intravenously every 4 weeks.
936914|NCT00988208|B3|Baseline|Total|Total of all reporting groups
936915|NCT00988208|B2|Baseline|Docetaxel + Prednisone + Lenalidomide (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
936916|NCT00988208|B1|Baseline|Oral Placebo + Docetaxel IV Day 1 + Prednisone (DP)|The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
936917|NCT00988208|P2|Participant Flow|Docetaxel/Prednisone/Lenalidomide (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
936955|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936918|NCT00988208|P1|Participant Flow|Docetaxel/Prednisone/Placebo (DP)|The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
936919|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1;5 mg prednisone orally twice each day (BID) each day of a 21 day treatment cycle
936920|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP treatment arm: Oral placebo once each day (QD) on Days 1-14 of a 21 days treatment cycle plus 75 mg/m^2 docetaxel intravenous (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) of a 21 day treatment cycle
936921|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
936922|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
936923|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
936924|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
936925|NCT00988208|O2|Outcome|Docetaxel/Prednisone/Lenalidomide (DPL)|DPL-The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel (IV) on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
936926|NCT00988208|O1|Outcome|Docetaxel/Prednisone/Placebo (DP)|DP-The 21-day treatment regimen consisted of: identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel Intravenous (IV) on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
936927|NCT00988208|E2|Reported Event|Lenalidomide/Docetaxel/Prednisone (DPL)|The 21-day treatment regimen consisted of: 25 mg lenalidomide orally once each day (QD) on Days 1-14; 75 mg/m^2 docetaxel IV on Day 1 and 5 mg prednisone orally twice each day (BID) each day of the treatment cycle, Days 1-21 (21 days).
936928|NCT00988208|E1|Reported Event|Docetaxel/Prednisone/Placebo (DP)|The 21-day treatment regimen consisted of: Identical matching oral placebo once each day (QD) on Days 1-14; 75 mg/m^2 Docetaxel IV on Day 1 and 5 mg Prednisone orally twice each day (BID) of the treatment cycle, Days 1-21 (21 days).
936929|NCT00988169|B1|Baseline|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
936930|NCT00988169|P1|Participant Flow|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
936931|NCT00988169|O1|Outcome|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
936932|NCT00988169|E1|Reported Event|Oral Erlotinib and Pulsed Doses of Oral AT-101|Treatment-naïve advanced (Wet Stage IIIB and IV)NSCLC patients with EGFR activating mutations.
936933|NCT00988156|B3|Baseline|Total|Total of all reporting groups
936934|NCT00988156|B2|Baseline|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL or matching placebo. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
936935|NCT00988156|B1|Baseline|Placebo|Placebo matching placebo
936936|NCT00988156|P2|Participant Flow|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was ESL. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
936937|NCT00988156|P1|Participant Flow|Placebo|Placebo matching placebo
936938|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
936939|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
936940|NCT00988156|O2|Outcome|Esl (BIA 2-093)|Eslicarbazepine acetate (Esl) (BIA 2-093) The study treatment was Esl. These treatments were provided as an oral suspension (50 mg/mL) and as white oblong tablets (200 mg).
936941|NCT00988156|O1|Outcome|Placebo|Placebo matching placebo
936942|NCT00988156|E2|Reported Event|Esl (Safety Set Part I)|
936943|NCT00988156|E1|Reported Event|Placebo (Safety Set Part I)|
936944|NCT00988143|B4|Baseline|Total|Total of all reporting groups
936945|NCT00988143|B3|Baseline|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936946|NCT00988143|B2|Baseline|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936947|NCT00988143|B1|Baseline|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936948|NCT00988143|P3|Participant Flow|Study Group 3 (QIV)|Participants received the Quadrivalent Influenza Vaccine
936949|NCT00988143|P2|Participant Flow|Study Group 2 (2008-2009 TIV)|Participants received the 2008-2009 Trivalent Influenza Vaccine
936950|NCT00988143|P1|Participant Flow|Study Group 1 (2009-2010 TIV)|Participants received the 2009-2010 Trivalent Influenza Vaccine (Pediatric dose with no preservatives)
936951|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936952|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936953|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936954|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936956|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936957|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936958|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936959|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936960|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936961|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936962|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936963|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936964|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936965|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936966|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936967|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936968|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936969|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936970|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936971|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
951294|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
936972|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936973|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936974|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936975|NCT00988143|O3|Outcome|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936976|NCT00988143|O2|Outcome|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936977|NCT00988143|O1|Outcome|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936978|NCT00988143|E3|Reported Event|Study Group 3 (Quadrivalent Influenza Vaccine)|Participants received the Quadrivalent Influenza Vaccine (QIV)
936979|NCT00988143|E2|Reported Event|Study Group 2 (2008-2009 Trivalent Influenza Vaccine)|Participants received the 2008-2009 Trivalent Influenza Vaccine (TIV)
936980|NCT00988143|E1|Reported Event|Study Group 1 (2009-2010 Trivalent Influenza Vaccine)|Participants received the 2009-2010 Trivalent Influenza Vaccine (TIV)
936981|NCT00988117|B1|Baseline|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
936982|NCT00988117|P1|Participant Flow|Rivastigmine|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
936983|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
936984|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
936985|NCT00988117|O1|Outcome|Rivastigmine 4.6mg/24 Hours to 9.5mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4 and at 9.5 mg/24 hours from week 4 to 12.
936986|NCT00988117|E2|Reported Event|Rivastigmine 9.5 mg/24 Hours|The Exelon patch was administered at a dosage of 9.5 mg/24 hours from week 4 to 12.
936987|NCT00988117|E1|Reported Event|Rivastigmine 4.6mg/24 Hours|The Exelon patch (rivastigmine, Novartis International AG, Basel, Switzerland) was administered at a dosage of 4.6 mg/24 hours from baseline to week 4.
936988|NCT00988091|B3|Baseline|Total|Total of all reporting groups
936989|NCT00988091|B2|Baseline|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
936990|NCT00988091|B1|Baseline|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
936991|NCT00988091|P2|Participant Flow|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
937298|NCT00986856|B2|Baseline|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
936992|NCT00988091|P1|Participant Flow|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
936993|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
936994|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
936995|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
936996|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
936997|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
951295|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
936998|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
936999|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
937000|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
937001|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
937002|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
937003|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
937004|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
937005|NCT00988091|O2|Outcome|IA-BioHA|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they received a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and were followed for an additional 26 weeks.
937006|NCT00988091|O1|Outcome|IA-SA|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period. Participants had the option of continuing into the open-label period in which they could receive a single intra-articular injection of 1.2% sodium hyaluronate (IA-BioHA) into the target knee and be followed for an additional 26 weeks.
937007|NCT00988091|E3|Reported Event|IA-BioHA: Open-label Period|Participants had the option of continuing into the open-label period in which their target knee received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) and they were followed for an additional 26 weeks.
937008|NCT00988091|E2|Reported Event|IA-BioHA: Double-blind Period|Each participant received a single intra-articular (IA) injection of 1.2% sodium hyaluronate (BioHA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
951421|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
937009|NCT00988091|E1|Reported Event|IA-SA: Double-blind Period|Each participant received a single intra-articular (IA) injection of buffered saline (SA) into the target knee, and was followed for a total of 26 weeks in the double-blind period.
937010|NCT00988065|B4|Baseline|Total|Total of all reporting groups
937011|NCT00988065|B3|Baseline|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937012|NCT00988065|B2|Baseline|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937013|NCT00988065|B1|Baseline|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937014|NCT00988065|P3|Participant Flow|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937015|NCT00988065|P2|Participant Flow|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937016|NCT00988065|P1|Participant Flow|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937017|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937018|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937019|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937020|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937021|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937022|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937023|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
951296|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
937024|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937025|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937026|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937027|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937028|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937029|NCT00988065|O3|Outcome|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937030|NCT00988065|O2|Outcome|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937031|NCT00988065|O1|Outcome|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937032|NCT00988065|E3|Reported Event|Placebo|Participants were to receive one dose of placebo intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937033|NCT00988065|E2|Reported Event|Sugammadex 16 mg/kg|Participants were to receive one dose of sugammadex 16 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937034|NCT00988065|E1|Reported Event|Sugammadex 4 mg/kg|Participants were to receive one dose of sugammadex 4 mg/kg intravenous bolus injection on Day 8, Day 36, and Day 78 of the study.
937035|NCT00987948|B1|Baseline|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
937036|NCT00987948|P1|Participant Flow|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
937037|NCT00987948|O1|Outcome|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
937038|NCT00987948|O1|Outcome|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
937039|NCT00987948|E1|Reported Event|Maraviroc|maraviroc (Selzentry): dosage varies with other medications being taken; will follow package insert guidelines
937040|NCT00987935|B10|Baseline|Total|Total of all reporting groups
937041|NCT00987935|B9|Baseline|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937042|NCT00987935|B8|Baseline|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937043|NCT00987935|B7|Baseline|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937044|NCT00987935|B6|Baseline|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937045|NCT00987935|B5|Baseline|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937046|NCT00987935|B4|Baseline|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937047|NCT00987935|B3|Baseline|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937048|NCT00987935|B2|Baseline|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937049|NCT00987935|B1|Baseline|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
937050|NCT00987935|P9|Participant Flow|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937051|NCT00987935|P8|Participant Flow|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937052|NCT00987935|P7|Participant Flow|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937053|NCT00987935|P6|Participant Flow|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937054|NCT00987935|P5|Participant Flow|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937137|NCT00987623|B1|Baseline|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937055|NCT00987935|P4|Participant Flow|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937056|NCT00987935|P3|Participant Flow|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937057|NCT00987935|P2|Participant Flow|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937058|NCT00987935|P1|Participant Flow|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
937059|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
937060|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937061|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
937062|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937063|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
937064|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937065|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
937066|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937067|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
937068|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937069|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
937070|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937071|NCT00987935|O2|Outcome|Group 2|Phase I Group 2 treatment consists of nintedanib, 50, 100, 150 or 200 mg twice daily:
937072|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937073|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937251|NCT00986986|P1|Participant Flow|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
937074|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937075|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937076|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937077|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937078|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937079|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937080|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937081|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937082|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937138|NCT00987623|P2|Participant Flow|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937083|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937084|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937085|NCT00987935|O1|Outcome|Phase I Group 1, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
937086|NCT00987935|O9|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937087|NCT00987935|O8|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937088|NCT00987935|O7|Outcome|Phase I Group 2, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937089|NCT00987935|O6|Outcome|Phase I Group 2, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937090|NCT00987935|O5|Outcome|Phase I Group 2, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937091|NCT00987935|O4|Outcome|Phase I Group 2, 50 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937092|NCT00987935|O3|Outcome|Phase I Group 1, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937093|NCT00987935|O2|Outcome|Phase I Group 1, 150 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the MTD and pharmacokinetics (PK) of nintedanib."
937094|NCT00987935|O1|Outcome|Phase I Group I, 100 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid).~Phase I: A standard 3+3 dose escalation part to determine the maximal tolerated dose (MTD) and pharmacokinetics (PK) of nintedanib."
937095|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937096|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937252|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
951422|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
937097|NCT00987935|O2|Outcome|Phase II, 400 mg Sorafenib Bid|"Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937098|NCT00987935|O1|Outcome|Phase II, 200 mg Nintedanib Bid|"Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid).~Phase II: Patients were randomly assigned to open-label treatment with nintedanib or sorafenib. Patients were stratified for macro-vascular invasion (MVI) and/or extra-hepatic spread (EHS)."
937099|NCT00987935|O2|Outcome|Group 2|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937100|NCT00987935|O1|Outcome|Group 1|"Patients treated with nintedanib belonging to Group1 from the 2 phases,~Phase I Group 1 treatment consists of nintedanib, 100, 150 or 200 mg twice daily (bid)~Phase II treatment consists of Nintedanib 200 mg twice daily (bid)"
937101|NCT00987935|E9|Reported Event|Phase II Sorafenib, 400 mg Bid|Oral administration of Sorafenib 400 mg film coated tablets twice daily (bid) during Phase II
937102|NCT00987935|E8|Reported Event|Phase II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) during Phase II
937103|NCT00987935|E7|Reported Event|Phase I Group II Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
937104|NCT00987935|E6|Reported Event|Phase I Group II Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
937105|NCT00987935|E5|Reported Event|Phase I Group II Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
937106|NCT00987935|E4|Reported Event|Phase I Group II Nintedanib, 50 mg Bid|Oral administration of Nintedanib (BIBF 1120) 50 mg soft gelatine capsules twice daily (bid) for the Group II patients during Phase I
937107|NCT00987935|E3|Reported Event|Phase I Group I Nintedanib, 200 mg Bid|Oral administration of Nintedanib (BIBF 1120) 200 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
937108|NCT00987935|E2|Reported Event|Phase I Group I Nintedanib, 150 mg Bid|Oral administration of Nintedanib (BIBF 1120) 150 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
937109|NCT00987935|E1|Reported Event|Phase I Group I Nintedanib, 100 mg Bid|Oral administration of Nintedanib (BIBF 1120) 100 mg soft gelatine capsules twice daily (bid) for the Group I patients during Phase I
937110|NCT00987831|B4|Baseline|Total|Total of all reporting groups
937111|NCT00987831|B3|Baseline|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
937112|NCT00987831|B2|Baseline|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
937113|NCT00987831|B1|Baseline|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppresion vs themselves serving as their own control flaring later....not on immune suppression.
937114|NCT00987831|P3|Participant Flow|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
937115|NCT00987831|P2|Participant Flow|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
937116|NCT00987831|P1|Participant Flow|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
937117|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease is now defined as BILAG < 17 in cumulative score
937118|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease is now defined as total cumulative BILAG score >/= 17
937119|NCT00987831|O2|Outcome|Moderate Disease Activity at Baseline|this is fully explained above. Moderate disease activity is defined as up to 3 BILAG B, no A, and SLEDAI </= 10.
937120|NCT00987831|O1|Outcome|Severe Disease Activity at Baseline|This is fully explained above. Severe disease activity is defined as > 3 BILAG B, OR at least one BILAG A or SLEDAI > 10 OR Meets Definition for severe Flare on SELENA SLEDAI
937253|NCT00986986|O1|Outcome|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
937121|NCT00987831|E3|Reported Event|Group B SLE One Time Donation|We amended protocol with IRB approval to include more patients in this group and ended up recruiting a total of 62. This was to allow enrichment of a cross sectional study of biomarkers related to the different background immune suppressants used in Group A at baseline. By combining baseline samples from Group A and Group B data we had a total of 103 lupus samples to study cross sectionally comparing impact of methotrexate, mmf, azathioprine or no IS on a range of biomarkers.
937122|NCT00987831|E2|Reported Event|Group C Healthy Controls|"Healthy controls, age, sex and ethnicity matched to SLE study participants were recruited for two time blood donation as controls for the biomarker studies~Blood drawing and brief history only : No treatments given"
937123|NCT00987831|E1|Reported Event|Group A Medication Withdrawal, Depomedrol, Prospective Follow-|When depomedrol was given, any immune suppressant being taken (e.g. aza, mmf, mtx) was stopped and biomarkers studied before and after this change. Depomedrol was expected to last 1-3 months, serial biomarkers were drawn until time of any flare, designated as end of study. Patients could elect to continue to donate blood samples per protocol up to one year. Of 41 patients who improved after depomedrol and could complete Group A, 40 flared at or before the six month visit. One patient continued for one year and did not flare. This study design allowed the comparison of 40 patients flaring at baseline on or not on background immune suppression vs themselves serving as their own control flaring later....not on immune suppression.
937124|NCT00987727|B3|Baseline|Total|Total of all reporting groups
937125|NCT00987727|B2|Baseline|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
937126|NCT00987727|B1|Baseline|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
937127|NCT00987727|P2|Participant Flow|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
937128|NCT00987727|P1|Participant Flow|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
937129|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
937130|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
937131|NCT00987727|O2|Outcome|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
937132|NCT00987727|O1|Outcome|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
937133|NCT00987727|E2|Reported Event|Sodium Hyaluronate 0.18% (VISMED® Multi)|sodium hyaluronate 0.18% (VISMED® Multi)
937134|NCT00987727|E1|Reported Event|Carboxymethylcellulose 0.5% and Glycerin 0.9% (OPTIVE® MD)|carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
937135|NCT00987623|B3|Baseline|Total|Total of all reporting groups
937136|NCT00987623|B2|Baseline|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937139|NCT00987623|P1|Participant Flow|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937140|NCT00987623|O2|Outcome|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937141|NCT00987623|O1|Outcome|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937142|NCT00987623|E2|Reported Event|Narafilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937143|NCT00987623|E1|Reported Event|Nelfilcon A|Commercially marketed contact lens worn in both eyes on a daily wear, daily disposable basis for one week.
937144|NCT00987558|B1|Baseline|Eslicarbazepine Acetate + Simvastatin|"Simvastatin 80 mg + eslicarbazepine acetate 800 mg~Simvastatin + ESL: Oral single-dose of simvastatin 80 mg on two occasions ─ once administered alone and once after treatment with an oral once-daily dose of 800 mg of ESL for 14 days ─ separated by a washout period of 3 weeks or more."
937145|NCT00987558|P2|Participant Flow|ESL, Then Simvastatin|Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day Washout period - 3 weeks Simvastatin 80 mg - Oral single-dose administered alone
937146|NCT00987558|P1|Participant Flow|Simvastatin, Then ESL + Simvastatin|Simvastatin 80 mg - Oral single-dose administered alone Washout period - 3 weeks Eslicarbazepine acetate (ESL) 800 mg - Oral once-daily dose for 14 days + Simvastatin single dose 80 mg on 14th day
937147|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
937148|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
937149|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
937150|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
937151|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
937152|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
937153|NCT00987558|O2|Outcome|ESL + Simvastatin (Test)|Eslicarbazepine acetate (ESL) 800 mg + Simvastatin 80 mg
937154|NCT00987558|O1|Outcome|Simvastatin (Reference)|Simvastatin 80 mg
937155|NCT00987558|E3|Reported Event|Eslicarbazepine Acetate + Simvastatin|Simvastatin 80 mg + eslicarbazepine acetate 800 mg
937156|NCT00987558|E2|Reported Event|Eslicarbazepine Acetate|eslicarbazepine acetate 800 mg
937157|NCT00987558|E1|Reported Event|Simvastatin|Simvastatin 80 mg
937158|NCT00987467|B1|Baseline|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
937243|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937244|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937159|NCT00987467|P1|Participant Flow|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
937160|NCT00987467|O1|Outcome|Topical Steroid Resistant/Dependant AKC|Patients with topical steroid resistant or dependant AKC were used for this study.
937161|NCT00987467|O1|Outcome|Patients With Steroid Resistant/ Dependant AKC.|Ten patients with significant AKC either steroid dependent or resistant who were having active inflammation were enrolled in this study.
937162|NCT00987467|E1|Reported Event|Cyclosporine|"Patients with atopic keratoconjunctivitis were started with cyclosporine 0.05% ophthalmic eye drops, starting with 1 drop in both eyes 6 times daily for first month, followed by 1 drop in both eyes 4 times daily for the following month, then adjusted by clinician as needed for appropriate disease control.~Cyclosporins : Cyclosporine 0.05% ophthalmic solution, 6 times in both eyes daily for first month, then 4 times in both eyes daily for next month, then dosage was adjusted based on clinical disease by investigator"
937163|NCT00987415|B3|Baseline|Total|Total of all reporting groups
937164|NCT00987415|B2|Baseline|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937165|NCT00987415|B1|Baseline|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937166|NCT00987415|P2|Participant Flow|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937167|NCT00987415|P1|Participant Flow|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937168|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937169|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937170|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937171|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937172|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937173|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
951297|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
937174|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937175|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937176|NCT00987415|O2|Outcome|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937177|NCT00987415|O1|Outcome|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937178|NCT00987415|E2|Reported Event|Sugar Pill|"Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~sugar pill: Matching placebo 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937179|NCT00987415|E1|Reported Event|Allopurinol|"Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks.~allopurinol: Allopurinol 300 mg daily for one week, then 600 mg daily to complete 24 weeks."
937180|NCT00987402|B3|Baseline|Total|Total of all reporting groups
937181|NCT00987402|B2|Baseline|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
937182|NCT00987402|B1|Baseline|Plain Soap and Water|Surgical hand preparation with plain soap and water
937183|NCT00987402|P2|Participant Flow|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
937184|NCT00987402|P1|Participant Flow|Plain Soap and Water|Surgical hand preparation with plain soap and water
937185|NCT00987402|O2|Outcome|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
937186|NCT00987402|O1|Outcome|Plain Soap and Water|Surgical hand preparation with plain soap and water
937187|NCT00987402|E2|Reported Event|Alcohol Based Hand Rubs|Surgical hand preparation with alcohol based alcohol hand rub
937188|NCT00987402|E1|Reported Event|Plain Soap and Water|Surgical hand preparation with plain soap and water
937189|NCT00987337|B4|Baseline|Total|Total of all reporting groups
937190|NCT00987337|B3|Baseline|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937245|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
951423|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
937191|NCT00987337|B2|Baseline|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937192|NCT00987337|B1|Baseline|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937193|NCT00987337|P3|Participant Flow|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937194|NCT00987337|P2|Participant Flow|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937195|NCT00987337|P1|Participant Flow|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 milligram (mg) tablet orally twice daily as blinded therapy along with pegylated interferon alpha-2a (pegIFN alpha-2a) 180 microgram (mcg) subcutaneously once weekly and ribavirin (RBV) 1000 milligram per day (mg/day) to participants weighing less than or equal to(<=) 75 kilogram (kg) or RBV 1200 mg/day to participants weighing greater than (>) 75 kg, orally in 2 divided doses up to Week 24. Participants with undetectable hepatitis C virus (HCV) ribonucleic acid (RNA) (HCV RNA <15 international units/milliliter [IU/mL]) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (greater than or equal to [>=] 15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75kg or RBV 1200 mg/day if participant weighed >75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937364|NCT00986544|B1|Baseline|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
937365|NCT00986544|P2|Participant Flow|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
937196|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937197|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937198|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937199|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937246|NCT00986999|E1|Reported Event|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937247|NCT00986986|B3|Baseline|Total|Total of all reporting groups
951424|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
937200|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937201|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937202|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937203|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937204|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937205|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937366|NCT00986544|P1|Participant Flow|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
937367|NCT00986544|O2|Outcome|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
951298|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
937206|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937207|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937208|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937248|NCT00986986|B2|Baseline|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
937249|NCT00986986|B1|Baseline|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
937250|NCT00986986|P2|Participant Flow|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
937299|NCT00986856|B1|Baseline|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937209|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937210|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937211|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937212|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937213|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937214|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937215|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937368|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
937216|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937217|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937218|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937219|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937220|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937221|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937222|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937223|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937224|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
937225|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72.
937226|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937369|NCT00986544|O2|Outcome|Drain|Drain positioned in the subhepatic space after laparoscopic cholecystectomy
951299|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
937227|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937228|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937229|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937230|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937231|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937232|NCT00987337|O3|Outcome|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937233|NCT00987337|O2|Outcome|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937234|NCT00987337|O1|Outcome|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937235|NCT00987337|E3|Reported Event|Placebo Plus pegIFN/RBV|Placebo matched to filibuvir tablet orally twice daily as blinded therapy in combination with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg, orally in 2 divided doses up to Week 24 followed by open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 48. Participants were then followed through Week 72.
937236|NCT00987337|E2|Reported Event|Filibuvir 600 mg Plus pegIFN/RBV|Filibuvir 600 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937370|NCT00986544|O1|Outcome|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
937237|NCT00987337|E1|Reported Event|Filibuvir 300 mg Plus pegIFN/RBV|Filibuvir 300 mg tablet orally twice daily as blinded therapy along with pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day to participants weighing <=75 kg or RBV 1200 mg/day to participants weighing >75 kg orally in 2 divided doses up to Week 24. Participants with undetectable HCV RNA (plasma HCV RNA <15 IU/mL) from Week 4 through 24 were discontinued from therapy and followed through Week 72. Participants with detectable HCV RNA (>=15 IU/mL) at Week 4 or later but undetectable at Week 24 received open-label pegIFN alpha-2a 180 mcg subcutaneously once weekly and RBV 1000 mg/day if participant weighed <=75 kg or RBV 1200 mg/day if participant weighed > 75 kg, orally in 2 divided doses up to Week 48 and then followed through Week 72.
937238|NCT00986999|B1|Baseline|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937239|NCT00986999|P1|Participant Flow|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937240|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937241|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937242|NCT00986999|O1|Outcome|Rosuvastatin|"rosuvastatin 10 mg qd increased to 20 mg qd as tolerated~rosuvastatin: rosuvastatin 20 mg tablet, 1/2 tab qd increased to a full tablet qd as tolerated x 6 months with optional extension to 2 years"
937305|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937256|NCT00986986|O2|Outcome|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
937257|NCT00986986|O1|Outcome|Extended Release Niacin|HIV infected individuals receiving extended release niacin
937258|NCT00986986|E2|Reported Event|Observation|Subjects in this arm will be monitored for 12 weeks and will not receive extended release niacin
937259|NCT00986986|E1|Reported Event|Active Drug (Extended Release Niacin)|Subjects in this arm will be given 12 weeks of extended release niacin
937260|NCT00986973|B1|Baseline|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day KUVAN for four months.
937261|NCT00986973|P1|Participant Flow|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
937262|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
937263|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
937264|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
937371|NCT00986544|E2|Reported Event|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
937912|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937265|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
937266|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
937267|NCT00986973|O1|Outcome|Sapropterin (KUVAN)|All subjects received 20 mg/kg/day Sapropterin (KUVAN) for four months. Subjects were examined with fluorodeoxyglucose positron emission tomography (FDG-PET) brain imaging, physical and neurological exam, blood tests for phenylalanine (Phe) and tyrosine levels, and neuropsychological testing before and 4 months after KUVAN therapy. Subjects' Phe and tyrosine levels were monitored weekly during the study and subjects kept 3-day diet records to allow for calculation of Phe intake.
937268|NCT00986973|O1|Outcome|Sapropterin (KUVAN) Therapy|All subjects received KUVAN at a dose of 20/mg/kg/day for four months. Blood Phe levels were measured drawn before therapy and 4 months after starting therapy.
937269|NCT00986973|E1|Reported Event|Sapropterin (KUVAN) Therapy|All subjects will received KUVAN therapy 20 mg/kg/day for four months.
937270|NCT00986960|B3|Baseline|Total|Total of all reporting groups
937271|NCT00986960|B2|Baseline|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
937272|NCT00986960|B1|Baseline|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
937273|NCT00986960|P2|Participant Flow|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
937274|NCT00986960|P1|Participant Flow|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
937275|NCT00986960|O2|Outcome|Placebo|Saline: I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
937276|NCT00986960|O1|Outcome|Adrenocorticotropin Hormone|repository corticotropin injection: IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
937277|NCT00986960|E2|Reported Event|Placebo|Saline : I.M. placebo - 1ml of saline I.M. once per day for 5 consecutive days at 0, 3, 6, 9, and 12 months.
937278|NCT00986960|E1|Reported Event|Adrenocorticotropin Hormone|repository corticotropin injection : IM ACTH: 80 units of Acthra gel I.M. once a day for 5 consecutive days at study time points 0, 3, 6, 9, and 12 months
937279|NCT00986947|B1|Baseline|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
937300|NCT00986856|P2|Participant Flow|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937301|NCT00986856|P1|Participant Flow|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937280|NCT00986947|P1|Participant Flow|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
937281|NCT00986947|O1|Outcome|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
937282|NCT00986947|O1|Outcome|IvIg With Rituximab|"IVIg and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
937283|NCT00986947|E1|Reported Event|IvIg With Rituximab|"Intravenous immunoglobulin (IVIg) and rituximab: A maximum of four doses (each single dose being 2gm/kg) of IVIg will be administered over a four-month period, with one dose administered each month. Each single dose of 2gm/kg will be administered in two half-doses (1gm/kg each) to be given one day apart, with one day of hemodialysis on the intervening day between the two half-doses.~If a compatible kidney transplant organ offer is received, upon admission to the hospital and immediately prior to the transplant operation, patients will receive a single infusion of Rituximab (375 mg/m2 BSA)."
937284|NCT00986921|B3|Baseline|Total|Total of all reporting groups
937285|NCT00986921|B2|Baseline|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937372|NCT00986544|E1|Reported Event|Absence of Drain|After laparoscopic gallbladder removal no suction drain positioned in the subhepatic space.
937373|NCT00986479|B3|Baseline|Total|Total of all reporting groups
937641|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937286|NCT00986921|B1|Baseline|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937287|NCT00986921|P2|Participant Flow|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following mifepristone, by standard surgical technique."
937288|NCT00986921|P1|Participant Flow|Standard Osmotic Dilator Insertion|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard surgical technique."
937289|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937290|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937291|NCT00986921|O2|Outcome|Mifepristone|Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted
937292|NCT00986921|O1|Outcome|Standard Osmotic Dilators|Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.
937293|NCT00986921|O2|Outcome|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted. No osmotic dilators are used.~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937294|NCT00986921|O1|Outcome|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937295|NCT00986921|E2|Reported Event|Mifepristone|"Women in the mifepristone are would take mifepristone 200 mg the day before their procedure, and not have dilators inserted~Mifepristone 200 mg : mifepristone would be given the day before the procedure~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937296|NCT00986921|E1|Reported Event|Standard Osmotic Dilators|"Women assigned to this arm would have the standard procedure, which is insertion of osmotic dilators the day before the procedure.~Osmotic dilator insertion : osmotic dilators (3-6) would be inserted as usual the day before the procedure.~All women would have the surgical abortion procedure done on the day following osmotic dilator insertion by standard technique."
937297|NCT00986856|B3|Baseline|Total|Total of all reporting groups
937306|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937307|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937308|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937309|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937310|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937311|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937312|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937313|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937314|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937315|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937316|NCT00986856|O2|Outcome|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937317|NCT00986856|O1|Outcome|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937318|NCT00986856|E2|Reported Event|Fucidin® Cream Vehicle|Fucidin® cream vehicle 3 times daily for 10 days
937319|NCT00986856|E1|Reported Event|Fucidin® Cream|Fucidin® cream 20 mg/g 3 times daily for 10 days
937320|NCT00986674|B4|Baseline|Total|Total of all reporting groups
937321|NCT00986674|B3|Baseline|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937642|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937322|NCT00986674|B2|Baseline|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
937323|NCT00986674|B1|Baseline|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937324|NCT00986674|P3|Participant Flow|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937325|NCT00986674|P2|Participant Flow|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
937326|NCT00986674|P1|Participant Flow|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937327|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937328|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
937329|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937330|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937351|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
937331|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
937332|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937333|NCT00986674|O3|Outcome|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|"Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937334|NCT00986674|O2|Outcome|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|"Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~carboplatin: Given IV~paclitaxel: Given IV"
937374|NCT00986479|B2|Baseline|Placebo/AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937908|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937335|NCT00986674|O1|Outcome|Arm I (Carboplatin, Paclitaxel, Cetuximab)|"Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel: Given IV~cetuximab: Given IV"
937336|NCT00986674|E3|Reported Event|Arm III (Carboplatin, Paclitaxel, Cetuximab, Cixutumumab)|Patients receive carboplatin, paclitaxel, and cetuximab as in arm I. Patients also receive cixutumumab as in arm II. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab as in arm I and cixutumumab as in arm II.
937337|NCT00986674|E2|Reported Event|Arm II (Carboplatin, Paclitaxel, Cixutumumab)|Patients receive carboplatin and paclitaxel as in arm I. Patients also receive cixutumumab IV over 1 hour on days 1, 15, and 29. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cixutumumab alone on days 1, 15, and 29. Treatment with cixutumumab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
937338|NCT00986674|E1|Reported Event|Arm I (Carboplatin, Paclitaxel, Cetuximab)|Patients receive carboplatin IV over 15-30 minutes and paclitaxel IV over 3 hours on days 1 and 22 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 42 days for 2 courses. Patients with stable or responding disease after 2 courses proceed to maintenance therapy with cetuximab alone on days 1, 8, 15, 22, 29, and 36. Treatment with cetuximab repeats every 42 days in the absence of disease progression or unacceptable toxicity.
937339|NCT00986583|B3|Baseline|Total|Total of all reporting groups
937340|NCT00986583|B2|Baseline|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937341|NCT00986583|B1|Baseline|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
937342|NCT00986583|P2|Participant Flow|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937343|NCT00986583|P1|Participant Flow|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937344|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937345|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
937346|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937347|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
937348|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937349|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
937350|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937352|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937353|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds."
937354|NCT00986583|O2|Outcome|Non Statin Use|"Patients not taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937355|NCT00986583|O1|Outcome|Statin Use Group|"Patients taking simvastatin, lovastatin, atorvastatin, or pravastatin for at least three months.~Succinylcholine: Succinylcholine will be administered pre-induction over a period of 5 seconds"
937356|NCT00986583|E2|Reported Event|Nonstatin Users|
937357|NCT00986583|E1|Reported Event|Statin Users|
937358|NCT00986570|B1|Baseline|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
937359|NCT00986570|P1|Participant Flow|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
937360|NCT00986570|O1|Outcome|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
937361|NCT00986570|E1|Reported Event|Xeomin®|"Botulinum Toxin A in IM injections single dose as follows:~24U in Orbicularis Oculorum (External area, 3 sites in each side) 20U in Glabella (5 sites) 8U in Frontal muscle (4 sites)"
937362|NCT00986544|B3|Baseline|Total|Total of all reporting groups
937363|NCT00986544|B2|Baseline|Drain|drain positioned in the subhepatic space after laparoscopic cholecystectomy
937375|NCT00986479|B1|Baseline|AZD6765 (150 mg)/ Placebo|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937376|NCT00986479|P2|Participant Flow|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937377|NCT00986479|P1|Participant Flow|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937378|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937379|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937380|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937381|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937382|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937383|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937384|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937385|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937386|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937387|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937388|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937389|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937390|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937469|NCT00986349|O1|Outcome|EndoBarrier Liner Device at Baseline|HbA1c %
937391|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937392|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937393|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937394|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937395|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937396|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937397|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937434|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937398|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937399|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937400|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937401|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937402|NCT00986479|O2|Outcome|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937403|NCT00986479|O1|Outcome|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937404|NCT00986479|E2|Reported Event|Placebo|Patients randomized to receive a single intravenous (iv) infusion of placebo (saline solution) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of AZD6765 (150 mg) over 60 minutes during the second period.
937405|NCT00986479|E1|Reported Event|AZD6765 (150 mg)|Patients randomized to receive a single intravenous (iv) infusion of AZD6765 (150 mg) over 60 minutes during the first period, followed by a 7-day drug-free period, followed by a single iv infusion of placebo (saline solution) over 60 minutes during the second period.
937406|NCT00986453|B1|Baseline|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
937407|NCT00986453|P1|Participant Flow|Total Study Population|Subjects' individual breasts were prospectively randomized to the standard of care or PEAK PlasmaBlade.
937408|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
937409|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
937410|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
937411|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
937412|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
937413|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
937414|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
937415|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
937416|NCT00986453|O2|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
937417|NCT00986453|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
937418|NCT00986453|E2|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
937419|NCT00986453|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the entirety of the breast reduction, including the skin incision.
937420|NCT00986427|B3|Baseline|Total|Total of all reporting groups
937421|NCT00986427|B2|Baseline|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937422|NCT00986427|B1|Baseline|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937423|NCT00986427|P2|Participant Flow|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937424|NCT00986427|P1|Participant Flow|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937425|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937426|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937427|NCT00986427|O4|Outcome|Refresh® Dry Eye Untreated Nail|Refresh® Dry Eye Therapy Untreated Nail
937428|NCT00986427|O3|Outcome|Refresh® Dry Eye Treated Nail|Refresh® Dry Eye Therapy Treated Nail
937429|NCT00986427|O2|Outcome|Restasis® Arm Untreated Nail|Restasis® Untreated Nail
937430|NCT00986427|O1|Outcome|Restasis® Arm Treated Nail|Restasis® Treated Nail
937431|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937432|NCT00986427|O1|Outcome|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937433|NCT00986427|O2|Outcome|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
940877|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
937435|NCT00986427|E2|Reported Event|Refresh® Arm|Subjects will apply Refresh® Dry Eye therapy to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937436|NCT00986427|E1|Reported Event|Restasis® Arm|Subjects will apply Restasis® to the target nails for 24 weeks. Additionally, there is a 12 week follow up period post the treatment period.
937437|NCT00986401|B3|Baseline|Total|Total of all reporting groups
937438|NCT00986401|B2|Baseline|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
937439|NCT00986401|B1|Baseline|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
937440|NCT00986401|P2|Participant Flow|Sanctura XR® Then Glucophage® (BA)|Treatment Period 1: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD for 4 days) + Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Glucophage® (500 mg, BID) for 3.5 days.
937441|NCT00986401|P1|Participant Flow|Glucophage® Then Sanctura XR® (AB)|Treatment Period 1: Glucophage® (500 mg, BID) for 3.5 days. Washout: There will be a washout period of 3 days between each treatment period. Treatment Period 2: Sanctura XR® (60 mg, QD) for 10 days followed by Sanctura XR® (60 mg, QD) for 4 days + Glucophage® (500 mg, BID) for 3.5 days.
937442|NCT00986401|O2|Outcome|Sanctura XR® + Glucophage®|Sanctura XR® + Glucophage®
937443|NCT00986401|O1|Outcome|Sanctura XR®|Sanctura XR®
937444|NCT00986401|O2|Outcome|Glucophage® + Sanctura XR®|Glucophage® + Sanctura XR®
937445|NCT00986401|O1|Outcome|Glucophage®|Glucophage®
937446|NCT00986401|E3|Reported Event|Sanctura XR® in Combination With Glucophage®|Sanctura XR® in combination with Glucophage®
937447|NCT00986401|E2|Reported Event|Sanctura XR®|Sanctura XR®
937448|NCT00986401|E1|Reported Event|Glucophage®|Glucophage®
937449|NCT00986362|B3|Baseline|Total|Total of all reporting groups
937450|NCT00986362|B2|Baseline|Placebo|Placebo : Placebo intravitreal injection
937451|NCT00986362|B1|Baseline|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
937452|NCT00986362|P2|Participant Flow|Placebo|Placebo : Placebo intravitreal injection
937453|NCT00986362|P1|Participant Flow|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
937454|NCT00986362|O2|Outcome|Placebo|Placebo : Placebo intravitreal injection
937455|NCT00986362|O1|Outcome|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
937456|NCT00986362|E2|Reported Event|Placebo|Placebo : Placebo intravitreal injection
937457|NCT00986362|E1|Reported Event|Ocriplasmin|Ocriplasmin : 175µg ocriplasmin intravitreal injection
937458|NCT00986349|B1|Baseline|EndoBarrier Liner Device|EndoBarrier Liner: 52 week treatment of EndoBarrier Liner
937459|NCT00986349|P1|Participant Flow|EndoBarrier Liner Device|Enrolled Subjects
937460|NCT00986349|O1|Outcome|Diabetes|"Single Arm~EndoBarrier Liner: 52 week treatment of EnoBarrier Liner"
937461|NCT00986349|O1|Outcome|EndoBarrier Liner Device|52 week treatment of EndoBarrier Liner
937462|NCT00986349|O3|Outcome|No Change in Glucose-Lowering Meds at Week 52|Subjects who completed 12-month implant duration
937463|NCT00986349|O2|Outcome|Decrease in Glucose-Lowering Meds|Subjects who completed 12-month implant duration
937464|NCT00986349|O1|Outcome|Increase in Glucose-Lowering Meds at Week 52|Subjecst who completed 12 month implant duration
937465|NCT00986349|O5|Outcome|EndoBarrier Liner Device % at 52 Weeks|HbA1c
937466|NCT00986349|O4|Outcome|EndoBarrier Liner Device % at 9 Months|HbA1c
937467|NCT00986349|O3|Outcome|EndoBarrier Liner Device % at 6 Months|HbA1c
937468|NCT00986349|O2|Outcome|EndoBarrier Liner Device at 3 Months|HbA1c % One subject was removed at day 75 due to non-compliance with attending required visits.
937470|NCT00986349|E1|Reported Event|EndoBarrier Liner Device|All subjects who had a device attempted to be implanted. N = 23
937471|NCT00986258|B1|Baseline|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937472|NCT00986258|P1|Participant Flow|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937473|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
937474|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
937475|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
940878|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
937476|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
937477|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
937478|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
937479|NCT00986258|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
937480|NCT00986258|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
937481|NCT00986258|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
937482|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937483|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937484|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937485|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937486|NCT00986258|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937487|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937488|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937489|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937490|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937491|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937492|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937493|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937494|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937495|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937621|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937496|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937497|NCT00986258|O1|Outcome|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed) as necessary to achieve a balance between pain relief and a satisfactory level of tolerability. After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937498|NCT00986258|E1|Reported Event|Tapentadol Prolonged Release|All participants started with either 50 mg, 100 mg, or 150 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted to a level that provided adequate analgesia necessary to achieve a balance between pain relief and a satisfactory level of tolerability (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol prolonged release was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol immediate release 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol immediate release once 500 mg tapentadol prolonged release dose was reached.
937499|NCT00986245|B1|Baseline|Entire Study Population|Includes groups randomized to receive once daily first and twice daily first.
937500|NCT00986245|P2|Participant Flow|Ropinirole PR-Twice Daily First, Then Once Daily|Ropinirole prolonged release(PR) twice daily in first intervention period and once daily in second intervention period (without washout period)
937501|NCT00986245|P1|Participant Flow|Ropinirole PR-Once Daily First, Then Twice Daily|Ropinirole prolonged release(PR) once daily in first intervention period and twice daily in second intervention period (without washout period)
937502|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937503|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937504|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937505|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937506|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937507|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937508|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937509|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937510|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937511|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937512|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937513|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937514|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937515|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937516|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937517|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937518|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937519|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937520|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937521|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937522|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937523|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937524|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
951425|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
937525|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937526|NCT00986245|O2|Outcome|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
937527|NCT00986245|O1|Outcome|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole Prolonged release administered in either first intervention peirod or second intervention period.
937528|NCT00986245|O3|Outcome|No Preference|No preference group
937529|NCT00986245|O2|Outcome|Twice-daily|Twice-daily preferred group
937530|NCT00986245|O1|Outcome|Once-daily|Once-daily preferred group
937531|NCT00986245|E2|Reported Event|Twice-daily of Ropinirole PR|Twice-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937532|NCT00986245|E1|Reported Event|Once-daily of Ropinirole PR|Once-daily regimen of Ropinirole PR administered in either first intervention peirod or second intervention period.
937533|NCT00986232|B5|Baseline|Total|Total of all reporting groups
937534|NCT00986232|B4|Baseline|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937535|NCT00986232|B3|Baseline|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937536|NCT00986232|B2|Baseline|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937537|NCT00986232|B1|Baseline|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937538|NCT00986232|P4|Participant Flow|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937640|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937539|NCT00986232|P3|Participant Flow|ProQuad™ (High Dose)|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937540|NCT00986232|P2|Participant Flow|ProQuad™ (Middle Dose)|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937541|NCT00986232|P1|Participant Flow|ProQuad™ (Low Dose)|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937542|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937543|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937544|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937545|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937546|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937547|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937548|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937549|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937550|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937551|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937552|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937553|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937554|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937555|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937556|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937557|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937888|NCT00985725|B2|Baseline|Placebo|Administered orally once-daily for 9 weeks.
937558|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937559|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937560|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937561|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937562|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937563|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937564|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937565|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937566|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937567|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937568|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937569|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937570|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937571|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937572|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937573|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937574|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937575|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937576|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937577|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937578|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937579|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937580|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937581|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937582|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937583|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937584|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937585|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937586|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937587|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937588|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937589|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937590|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937591|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937592|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937593|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937594|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937595|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937596|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937597|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937598|NCT00986232|O7|Outcome|M-M-R™ II + PUVV After 1 Injection|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937599|NCT00986232|O6|Outcome|ProQuad™ (High Dose) After 2 Injections|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937600|NCT00986232|O5|Outcome|ProQuad™ (High Dose) After 1 Injection|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937601|NCT00986232|O4|Outcome|ProQuad™ (Middle Dose) After 2 Injections|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937602|NCT00986232|O3|Outcome|ProQuad™ (Middle Dose) After 1 Injection|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937603|NCT00986232|O2|Outcome|ProQuad™ (Low Dose) After 2 Injections|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937604|NCT00986232|O1|Outcome|ProQuad™ (Low Dose) After 1 Injection|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937605|NCT00986232|E7|Reported Event|ProQuad (High Dose) After Injection 2|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937606|NCT00986232|E6|Reported Event|ProQuad (Middle Dose) After Injection 2|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937607|NCT00986232|E5|Reported Event|ProQuad (Low Dose) After Injection 2|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937608|NCT00986232|E4|Reported Event|M-M-R™ II + PUVV (Process Upgrade Varicella Vaccine)|One M-M-R™ II (0.5-mL) SQ injection administered concomitantly with one PUVV (0.5-mL) SQ injection, at separate injection sites, on Day 0.
937609|NCT00986232|E3|Reported Event|ProQuad (High Dose) After Injection 1|One ProQuad™ (4.25 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937610|NCT00986232|E2|Reported Event|ProQuad (Middle Dose) After Injection 1|One ProQuad™ (3.97 log10 PFU/0.5-mL dose) SQ injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937611|NCT00986232|E1|Reported Event|ProQuad (Low Dose) After Injection 1|One ProQuad™ (3.48 log10 plaque-forming units [PFU]/0.5-mL dose) subcutaneous (SQ) injection administered on Day 0, followed by a second injection of the same material approximately 90 days later.
937612|NCT00986180|B3|Baseline|Total|Total of all reporting groups
937613|NCT00986180|B2|Baseline|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937614|NCT00986180|B1|Baseline|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937615|NCT00986180|P2|Participant Flow|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937616|NCT00986180|P1|Participant Flow|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937617|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937618|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937619|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937620|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
951426|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
937622|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937623|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937624|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937625|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937626|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937627|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937628|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937629|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937630|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937631|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937632|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937633|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937634|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937635|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937636|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937637|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937638|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937639|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937643|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937644|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937645|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937646|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937647|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937648|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937649|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937650|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937651|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937652|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937653|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937654|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937655|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937656|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937657|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937658|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937659|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937660|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937661|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937662|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937663|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937664|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937665|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937666|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937667|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937668|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937669|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937670|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937671|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937672|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937673|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
939419|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
937674|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937675|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937676|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937677|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937678|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937679|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937680|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937681|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937682|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937683|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937684|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937685|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937686|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937687|NCT00986180|O2|Outcome|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937688|NCT00986180|O1|Outcome|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937689|NCT00986180|E2|Reported Event|Oxycodone IR|5, 10 or 15 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 90 mg
937690|NCT00986180|E1|Reported Event|NUCYNTA|50, 75 or 100 mg every 4 to 6 hours as needed for pain for up to 10 days; max daily dose 600 mg
937691|NCT00986154|B3|Baseline|Total|Total of all reporting groups
938397|NCT00984867|B2|Baseline|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
937692|NCT00986154|B2|Baseline|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
937693|NCT00986154|B1|Baseline|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
937694|NCT00986154|P2|Participant Flow|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
937695|NCT00986154|P1|Participant Flow|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
937696|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
937697|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
937698|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
937699|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
937700|NCT00986154|O2|Outcome|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
951427|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
937701|NCT00986154|O1|Outcome|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
937702|NCT00986154|E2|Reported Event|Heparin/Warfarin|"low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment~warfarin: tablet for oral use; 0.5 mg, 1 mg, 2.5 mg, 5 mg; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; maximum of 12 months treatment"
937703|NCT00986154|E1|Reported Event|Heparin/Edoxaban Tosylate|"edoxaban tosylate(DU-176b): edoxaban tosylate(DU-176b), film-coated tablet for oral use, 30 mg, two tablets (60 mg) once daily, maximum of 12 months treatment~low molecular weight heparin/unfractionated heparin: LMW heparin - subcutaneous injection, 1 mg/Kg twice daily or 1.5 mg/Kg once daily.~Unfractionated heparin - 5,000 IU bolus intravenous administration, 1,300 IU/hour continuous infusion, minimum of 5 days and maximum of about 12 days treatment"
937704|NCT00986102|B5|Baseline|Total|Total of all reporting groups
937705|NCT00986102|B4|Baseline|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937706|NCT00986102|B3|Baseline|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937707|NCT00986102|B2|Baseline|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937708|NCT00986102|B1|Baseline|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937709|NCT00986102|P4|Participant Flow|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937710|NCT00986102|P3|Participant Flow|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937711|NCT00986102|P2|Participant Flow|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937712|NCT00986102|P1|Participant Flow|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937713|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937714|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937715|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937716|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937717|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937718|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937719|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937720|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937721|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937722|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937723|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937724|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937725|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937726|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937727|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937728|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937729|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937730|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937731|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937732|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937733|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937734|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937735|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937736|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937737|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937738|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937739|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937740|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937741|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937742|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937743|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937744|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937745|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937746|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937747|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937748|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937749|NCT00986102|O4|Outcome|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937750|NCT00986102|O3|Outcome|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
937751|NCT00986102|O2|Outcome|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937752|NCT00986102|O1|Outcome|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937753|NCT00986102|E4|Reported Event|Complicated Intra-abdominal Infection (cIAI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 10 days
937754|NCT00986102|E3|Reported Event|Complicated Urinary Tract Infection (cUTI)|500 mg of doripenem was administered every 8 hours as 1-hour infusion for 5 to 14 days
938398|NCT00984867|B1|Baseline|Placebo|Placebo plus sitagliptin alone or in combination with metformin
937755|NCT00986102|E2|Reported Event|Ventilator-Associated Pneumonia (VAP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937756|NCT00986102|E1|Reported Event|Nosocomial Pneumonia (NP)|500 mg of doripenem was administered every 8 hours as 1 or 4-hour infusion for 7 to 14 days
937757|NCT00985985|B5|Baseline|Total|Total of all reporting groups
937758|NCT00985985|B4|Baseline|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
937759|NCT00985985|B3|Baseline|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
937760|NCT00985985|B2|Baseline|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally.
937761|NCT00985985|B1|Baseline|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally.
937762|NCT00985985|P4|Participant Flow|Placebo Lozenge (High Dependence Smoke|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
937763|NCT00985985|P3|Participant Flow|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally. During week 1 to week 6, participants were recommended to take at least 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenge per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
937764|NCT00985985|P2|Participant Flow|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received placebo lozenge containing 0 mg of nicotine, orally. During week 1 to week 6, participants were recommended to take atleast 9 lozenges per day but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse
937765|NCT00985985|P1|Participant Flow|Nicotine Lozenge 2 Milligram (mg) (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes of waking received 2 mg of nicotine lozenge, orally. During week 1 to week 6,participants were recommended to take at least 9 lozenges per day, but not exceeding 15 lozenges. During week 7 to week 9, participants were recommended to use 12 to 6 lozenges per day, further taking 3 to 6 lozenges only by week 10 to 12. Afterwards, lozenge was taken when necessary to prevent relapse.
937766|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
937767|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking received 4 mg nicotine lozenge, orally.
937768|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine, orally.
937769|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
937770|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
938705|NCT00984165|B4|Baseline|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
937771|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
937772|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
937773|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge, orally.
937774|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
937775|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
937776|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
937777|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
937778|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine, orally.
937779|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
937780|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
937781|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
937782|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
937783|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
937784|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
937785|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
937786|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
937787|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
937788|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
937789|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
937790|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
937791|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
937792|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
937793|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
937794|NCT00985985|O4|Outcome|Placebo Lozenge (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received placebo lozenge containing 0 mg of nicotine orally.
937795|NCT00985985|O3|Outcome|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants, who smoked their first cigarette within 30 minutes after waking, received 4 mg nicotine lozenge orally.
937796|NCT00985985|O2|Outcome|Placebo Lozenge (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received placebo lozenge containing 0 mg of nicotine orally.
937797|NCT00985985|O1|Outcome|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants, who smoked their first cigarette after 30 minutes of waking, received 2 mg of nicotine lozenge orally.
937798|NCT00985985|E4|Reported Event|Placebo Lozenge (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
937799|NCT00985985|E3|Reported Event|Nicotine Lozenge 4 mg (High Dependence Smokers)|Participants who smoked their first cigarette within 30 minutes after waking received 4 mg of nicotine lozenge, orally.
937800|NCT00985985|E2|Reported Event|Placebo Lozenge (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received placebo lozenge containing 0 mg of nicotine, orally.
937801|NCT00985985|E1|Reported Event|Nicotine Lozenge 2 mg (Low Dependence Smokers)|Participants who smoked their first cigarette after 30 minutes after waking received 2 mg of nicotine lozenge, orally.
937802|NCT00985959|B4|Baseline|Total|Total of all reporting groups
937803|NCT00985959|B3|Baseline|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
937804|NCT00985959|B2|Baseline|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937805|NCT00985959|B1|Baseline|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937806|NCT00985959|P3|Participant Flow|Phase I and II - JNJ-26866138 1.3 mg/m2 Group|Phase I: JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles. Phase II: JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
937807|NCT00985959|P2|Participant Flow|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937808|NCT00985959|P1|Participant Flow|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937809|NCT00985959|O1|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
937810|NCT00985959|O1|Outcome|Prednisolone|Prednisolone 60 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
937811|NCT00985959|O1|Outcome|Melphalan|Melphalan 9 mg/m2 on day 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
937812|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937813|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937814|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937815|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
938399|NCT00984867|P2|Participant Flow|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
937816|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937817|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937818|NCT00985959|O5|Outcome|Total|Participants from both Phase I and Phase II
937819|NCT00985959|O4|Outcome|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
937820|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937821|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937822|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937823|NCT00985959|O3|Outcome|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937824|NCT00985959|O2|Outcome|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937825|NCT00985959|O1|Outcome|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937826|NCT00985959|E4|Reported Event|Phase II - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 8, 22 and 29 of 6-week cycle for 5-9 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 9 cycles
937827|NCT00985959|E3|Reported Event|Phase I - JNJ-26866138 1.3 mg/m2 Group|JNJ-26866138 1.3 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937828|NCT00985959|E2|Reported Event|Phase I - JNJ-26866138 1.0 mg/m2 Group|JNJ-26866138 1.0 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937829|NCT00985959|E1|Reported Event|Phase I - JNJ-26866138 0.7 mg/m2 Group|JNJ-26866138 0.7 mg/m2 on Days 1, 4, 8, 11, 22, 25, 29 and 32 of 6-week cycle up to 4 cycles. Melphalan 9 mg/m2 and Prednisolone 60 mg/m2 on Days 1, 2, 3 and 4 of 6-week cycle up to 4 cycles
937830|NCT00985829|B1|Baseline|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
937831|NCT00985829|P1|Participant Flow|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
937832|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
937833|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
951428|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
937834|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
937835|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
937836|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
937837|NCT00985829|O1|Outcome|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who were candidates for photodynamic therapy
937838|NCT00985829|E1|Reported Event|Aminolevulinic Acid-Photodynamic Therapy (ALA-PDT)|Patients with histologically proven basal cell carcinoma who would receive ALA-PDT for their lesion(s)
937839|NCT00985790|B3|Baseline|Total|Total of all reporting groups
937840|NCT00985790|B2|Baseline|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937841|NCT00985790|B1|Baseline|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937842|NCT00985790|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
938312|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1
937843|NCT00985790|P1|Participant Flow|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937844|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937845|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937846|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937847|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937848|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937849|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
939420|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
937850|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937851|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937852|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937853|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937854|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937909|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937910|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937855|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937856|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937857|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937858|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937859|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937860|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937861|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937862|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937863|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937864|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937886|NCT00985738|E1|Reported Event|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
937887|NCT00985725|B3|Baseline|Total|Total of all reporting groups
937865|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937866|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937867|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937868|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937869|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937870|NCT00985790|O2|Outcome|Fluarix-Unprimed Group|Subjects in this group were the unprimed subjects from the Fluarix Group, aged between 18 and 47 months, who received 2 doses of Fluarix™ vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937871|NCT00985790|O1|Outcome|GSK2321138A-Unprimed Group|Subjects in this group were the unprimed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 2 doses of GSK2321138A vaccine at Days 0 and 28, and who had not received any 2-dose priming influenza immunization in any previous year. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937872|NCT00985790|O2|Outcome|Fluarix-Primed Group|Subjects in this group were the primed subjects from the Fluarix Group, aged between 18 and 47 months, who received 1 dose of Fluarix™ vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937911|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937873|NCT00985790|O1|Outcome|GSK2321138A-Primed Group|Subjects in this group were the primed subjects from the GSK2321138A Group, aged between 18 and 47 months, who received 1 dose of GSK2321138A vaccine at Day 0, and who had previously received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937874|NCT00985790|O2|Outcome|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937875|NCT00985790|O1|Outcome|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937876|NCT00985790|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 47 months received the Fluarix™ vaccine. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the Fluarix-Primed Group) received 1 dose of Fluarix™ vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the the Fluarix-Unprimed Group) received 2 doses of Fluarix™ vaccine at Days 0 and 28. The Fluarix™ vaccine was administered intramuscularly in the deltoid of the right arm.
937877|NCT00985790|E1|Reported Event|GSK2321138A Group|Subjects aged between 18 and 47 months received the GSK2321138A. “Primed” subjects (subjects who had received a 2-dose priming immunization with Fluarix™ vaccine in study NCT00764790 – or the GSK2321138A-Primed Group) received 1 dose of GSK2321138A vaccine at Day 0. “Unprimed” subject (subjects who had not received any 2-dose priming influenza immunization in any previous year – or the GSK2321138A-Unprimed Group) received 2 doses of GSK2321138A vaccine at Days 0 and 28. The GSK2321138A vaccine was administered intramuscularly in the deltoid of the right arm.
937878|NCT00985738|B3|Baseline|Total|Total of all reporting groups
937879|NCT00985738|B2|Baseline|Placebo|This group received a placebo followed by 3D mapping biopsy.
937880|NCT00985738|B1|Baseline|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
937881|NCT00985738|P2|Participant Flow|Placebo|This group received a placebo followed by 3D mapping biopsy.
937882|NCT00985738|P1|Participant Flow|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
937883|NCT00985738|O2|Outcome|Placebo|This group received a placebo followed by 3D mapping biopsy.
937884|NCT00985738|O1|Outcome|Dutasteride|Dutasteride (Avodart) was administered at 0.5 mg dose and was given every day (QD) for 3 months, followed by 3D mapping biopsy.
937885|NCT00985738|E2|Reported Event|Placebo|This group received a placebo followed by 3D mapping biopsy.
937889|NCT00985725|B1|Baseline|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937890|NCT00985725|P2|Participant Flow|Placebo|Administered orally once-daily for 9 weeks.
937891|NCT00985725|P1|Participant Flow|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937892|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937893|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937894|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937895|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937896|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937897|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937898|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937899|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937900|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937901|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937902|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937903|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937904|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937905|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937906|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937907|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937913|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937914|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937915|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937916|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937917|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937918|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937919|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937920|NCT00985725|O2|Outcome|Placebo|Administered orally once-daily for 9 weeks.
937921|NCT00985725|O1|Outcome|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937922|NCT00985725|E2|Reported Event|Placebo|Administered orally once-daily for 9 weeks.
937923|NCT00985725|E1|Reported Event|Lisdexamfetamine Dimesylate (LDX)|Lisdexamfetamine Dimesylate (LDX, SPD489) is administered orally once-daily at doses of either 20, 30, 40, 50, 60, or 70 mg for 9 weeks.
937924|NCT00985712|B3|Baseline|Total|Total of all reporting groups
937925|NCT00985712|B2|Baseline|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937926|NCT00985712|B1|Baseline|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
937927|NCT00985712|P2|Participant Flow|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937928|NCT00985712|P1|Participant Flow|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
937929|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937930|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
937931|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937932|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
937933|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937934|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
937935|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937936|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
938706|NCT00984165|B3|Baseline|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
937937|NCT00985712|O2|Outcome|HumaPen Memoir|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937938|NCT00985712|O1|Outcome|HumaPen Luxura|Participant's insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
937939|NCT00985712|E2|Reported Event|HumaPen Memoir|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Memoir daily for 24 weeks
937940|NCT00985712|E1|Reported Event|HumaPen Luxura|Participant’s insulin dose of Insulin Lispro or Huminsulin Normal is delivered subcutaneously via HumaPen Luxura daily for 24 weeks
937941|NCT00985686|B5|Baseline|Total|Total of all reporting groups
937942|NCT00985686|B4|Baseline|Waitlist Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the waitlist arm.
937943|NCT00985686|B3|Baseline|Waitlist Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the waitlist arm.
937944|NCT00985686|B2|Baseline|Study Arm, Older Subgroup|Subgroup of participants 19-24 years of age randomized into the study arm.
937945|NCT00985686|B1|Baseline|Study Arm, Younger Subgroup|Subgroup of participants 13-18 years of age randomized into the study arm.
937946|NCT00985686|P4|Participant Flow|Waitlist Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
937964|NCT00985673|P5|Participant Flow|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938313|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
951300|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
937947|NCT00985686|P3|Participant Flow|Waitlist Arm, Younger Subgroup|"Arm where younger participants (13-18 years of age) received the LEAP Project intervention after an 8 week wait period.~At 8 weeks, the results from the wait-list arm (no intervention) were compared to the results of the study arm (intervention completed).~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
937948|NCT00985686|P2|Participant Flow|Study Arm, Older Subgroup|"Arm where older participants (19 to 24 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
937949|NCT00985686|P1|Participant Flow|Study Arm, Younger Subgroup|"Arm where younger participants (13 to 18 years of age) began the LEAP Project intervention upon recruitment for an 8 week period.~LEAP Project: In collaboration with experts from Alberta Health Services, the University of Calgary, and Mount Royal University, the Canadian Institute of Natural and Integrative Medicine (CINIM) has created the LEAP Project, a spirituality informed e-mental health intervention, for young people with major depressive disorders (see Appendix for sample materials). It is an online, eight module, multimedia intervention delivered over eight weeks, requiring a weekly commitment of 2-3 hours. The intervention is non-denominational and avoids a focus on any religious traditions. The program aims to treat depression by guiding depressed young people through an exploration of spiritual concepts and principles."
937950|NCT00985686|O1|Outcome|Older Subgroup (19-24 Years of Age)|Subgroup of participants 19-24 years of age. Participants were randomized into the Study and Waitlist Arms.
937951|NCT00985686|O1|Outcome|Younger Subgroup (13-18 Years of Age)|Subgroup of participants 13-18 years of age. Participants were randomized into the Study and Waitlist Arms.
937952|NCT00985686|E4|Reported Event|Waitlist Arm, Older Subgroup|Participants 19-24 years of age randomized into the wait list group
937953|NCT00985686|E3|Reported Event|Waitlist Arm, Younger Subgroup|Participants 13-18 years of age randomized into the waitlist group
937954|NCT00985686|E2|Reported Event|Study Arm, Older Subgroup|Participants 19-24 years of age randomized into the study group
937955|NCT00985686|E1|Reported Event|Study Arm, Younger Subgroup|Participants 13-18 years of age randomized into the study group
937956|NCT00985673|B7|Baseline|Total|Total of all reporting groups
937957|NCT00985673|B6|Baseline|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937958|NCT00985673|B5|Baseline|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937959|NCT00985673|B4|Baseline|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937960|NCT00985673|B3|Baseline|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937961|NCT00985673|B2|Baseline|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937962|NCT00985673|B1|Baseline|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937963|NCT00985673|P6|Participant Flow|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938220|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
938221|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
937965|NCT00985673|P4|Participant Flow|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937966|NCT00985673|P3|Participant Flow|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937967|NCT00985673|P2|Participant Flow|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937968|NCT00985673|P1|Participant Flow|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937969|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937970|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937971|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937972|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938239|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
937973|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937974|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937975|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937976|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937977|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937978|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937979|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938222|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
951301|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
937980|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937981|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937982|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937983|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937984|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937985|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937986|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937987|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
951429|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
937988|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937989|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937990|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937991|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937992|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937993|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937994|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938223|NCT00985543|O3|Outcome|LPV/r 200/50 mg|Lopinavir/ritonavir 200/50 mg twice daily (1 heat-stable 200/50 mg tablet BID)
938384|NCT00985114|E1|Reported Event|Device and Cross Over|"EndoBarrier~EndoBarrier: EndoBarrier implant"
937995|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937996|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937997|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937998|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
937999|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938000|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938001|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938032|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938002|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938003|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938004|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938005|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938006|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938007|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938008|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938009|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938224|NCT00985543|O2|Outcome|LPV/r 200/150 mg|Lopinavir/ritonavir 200/150 mg twice daily (1 heat-stable 200/50 mg tablet BID plus 1 ritonavir 100 mg capsule BID)
938385|NCT00985010|B3|Baseline|Total|Total of all reporting groups
938010|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938011|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938012|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938013|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938014|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938015|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938016|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938017|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938018|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938019|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938020|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938021|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938022|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938023|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938024|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938225|NCT00985543|O1|Outcome|LPV/r 400/100 mg|Lopinavir/ritonavir 400/100 mg twice daily (2 heat-stable 200/50 mg tablets twice daily (BID))
938386|NCT00985010|B2|Baseline|Males|Brain death
938025|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938026|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938027|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938028|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938029|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938030|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938031|NCT00985673|O7|Outcome|Flulaval/Placebo/(Unadjuvanted) Arepanrix Pooled Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the (unadjuvanted formulation of ) Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938033|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938034|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938035|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938036|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938037|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938038|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938039|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938299|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938040|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938041|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938042|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938043|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938044|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938045|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938046|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938062|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938047|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938048|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938049|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938050|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938051|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938052|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938053|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938054|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938300|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938055|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938056|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938057|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938058|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938059|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938060|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938061|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938063|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938064|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938065|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938066|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938067|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938068|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938069|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938301|NCT00985192|E1|Reported Event|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938070|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938071|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938072|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938073|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938074|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938075|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938076|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938092|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938077|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938078|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938079|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938080|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938081|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938082|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938083|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938084|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938302|NCT00985166|B4|Baseline|Total|Total of all reporting groups
938303|NCT00985166|B3|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
938085|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938086|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938087|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938088|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938089|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938090|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938091|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938093|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938094|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938095|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938096|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938097|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938098|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938099|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938304|NCT00985166|B2|Baseline|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
938387|NCT00985010|B1|Baseline|Females|Brain death
938100|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938101|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938102|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938103|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938104|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938105|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938106|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938122|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938107|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938108|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938109|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938110|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938111|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938112|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938113|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938114|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938305|NCT00985166|B1|Baseline|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
938115|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938116|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938117|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938118|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938119|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938120|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938121|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938123|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938124|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938125|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938126|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938127|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938128|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938129|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938306|NCT00985166|P3|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
938388|NCT00985010|P2|Participant Flow|Males|Brain death
938130|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938131|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938132|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938133|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938134|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938135|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938136|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938152|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938137|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938138|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938139|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938140|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938141|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938142|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938143|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938144|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938307|NCT00985166|P2|Participant Flow|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
938389|NCT00985010|P1|Participant Flow|Females|Brain death
938145|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938146|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938147|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938148|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938149|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938150|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938151|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938153|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938154|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938155|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938156|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938157|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938158|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938159|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938308|NCT00985166|P1|Participant Flow|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
938160|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938161|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938162|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938163|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938164|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938165|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938166|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938167|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938168|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938169|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938170|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938171|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938172|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938173|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938174|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938309|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
938390|NCT00985010|O2|Outcome|Males|Brain death
938175|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938176|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938177|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938178|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938179|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938180|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938181|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938182|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938850|NCT00983918|E4|Reported Event|Propofol|General Anesthesia with Propofol
938183|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938184|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938185|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938186|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938187|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938188|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938189|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938310|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
938391|NCT00985010|O1|Outcome|Females|Brain death
938190|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938191|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938192|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938193|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938194|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938195|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938196|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938212|NCT00985673|E6|Reported Event|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938197|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938198|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938199|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938200|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938201|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938202|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938203|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938204|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938311|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
938205|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938206|NCT00985673|O6|Outcome|Arepanrix/Placebo/Flulaval Group|subjects received co-administration of Arepanrix vaccine and saline placebo on Day 0 followed by Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938207|NCT00985673|O5|Outcome|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938208|NCT00985673|O4|Outcome|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938209|NCT00985673|O3|Outcome|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938210|NCT00985673|O2|Outcome|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938211|NCT00985673|O1|Outcome|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938213|NCT00985673|E5|Reported Event|Unadjuvanted Arepanrix/Placebo/Flulaval Group|subjects received co-administration of the unadjuvanted formulation of Arepanrix vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Flulaval vaccine on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938214|NCT00985673|E4|Reported Event|Flulaval/Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and Arepanrix vaccine on Day 0 followed by Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938215|NCT00985673|E3|Reported Event|Flulaval/Unadjuvanted Arepanrix/Placebo Group|subjects received co-administration of Flulaval vaccine and the unadjuvanted formulation of Arepanrix vaccine on Day 0 followed by the administration of the unadjuvanted formulation of Arepanrix vaccine on Day 21 and saline placebo on Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938216|NCT00985673|E2|Reported Event|Flulaval/Placebo/Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed the administration of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938217|NCT00985673|E1|Reported Event|Flulaval/Placebo/Unadjuvanted Arepanrix Group|subjects received co-administration of Flulaval vaccine and saline placebo on Day 0 followed by the unadjuvanted formulation of Arepanrix vaccine on Day 21 and Day 42. All vaccines were administered intramuscularly in the deltoids of the dominant or non dominant arm. At Day 0 the two vaccines were administered each in a separate arm, at Day 21 in the dominant arm and at Day 42 in the non-dominant arm.
938218|NCT00985543|B1|Baseline|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
938219|NCT00985543|P1|Participant Flow|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period. Pharmacokinetic evaluations were made over a 12-hour interval at the end of each dosing phase.
938226|NCT00985543|E1|Reported Event|All Study Participants|All participants were given three sequential doses of lopinavir/ritonavir: lopinavir/ritonavir 400/100mg twice daily (2 heat-stable 200/50mg tablets BID), lopinavir/ritonavir 200/150mg twice daily (1 heat-stable 200/50mg tablet BID plus 1 ritonavir 100mg capsule BID), lopinavir/ritonavir 200/50mg twice daily (1 heat-stable 200/50mg tablet BID). Each dosing phase lasted for 7 days and each phase was separated by a 7-day wash-out period.
938227|NCT00985504|B3|Baseline|Total|Total of all reporting groups
938228|NCT00985504|B2|Baseline|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938229|NCT00985504|B1|Baseline|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938230|NCT00985504|P2|Participant Flow|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938231|NCT00985504|P1|Participant Flow|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938232|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938233|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938234|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938235|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938236|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938237|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938238|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938240|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938241|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938242|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938243|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938244|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938245|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938246|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938247|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938248|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938249|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938250|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938392|NCT00985010|O2|Outcome|Males|Brain death
938393|NCT00985010|O1|Outcome|Females|Brain death
938251|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938252|NCT00985504|O2|Outcome|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938253|NCT00985504|O1|Outcome|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938254|NCT00985504|E2|Reported Event|Escitalopram|Participants received 10 mg of escitalopram QD po for 1 week (Acute Treatment Period) followed by 10-20 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938255|NCT00985504|E1|Reported Event|Duloxetine|Participants received 60 milligrams (mg) of duloxetine once daily (QD) by mouth (po) for 1 week (Acute Treatment Period) followed by 60-120 mg QD po for the remaining 7 weeks (Optimization Period), with an option to continue treatment for an additional 2 weeks.
938256|NCT00985491|B1|Baseline|EndoBarrier Liner Device|"46 subjects were enrolled. 3 subjects were implant failures. 43 Subjects received the device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
938257|NCT00985491|P1|Participant Flow|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
938258|NCT00985491|O1|Outcome|Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
938259|NCT00985491|O1|Outcome|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
938260|NCT00985491|E1|Reported Event|EndoBarrier Liner Device|"All patients will be implanted with the Endobarrier Liner device.~Endobarrier Liner: Medical device placed endoscopically in the duodenum"
938261|NCT00985439|B5|Baseline|Total|Total of all reporting groups
938262|NCT00985439|B4|Baseline|Placebo|
938263|NCT00985439|B3|Baseline|Celecoxib 400 mg|
938264|NCT00985439|B2|Baseline|Diclofenac Test (Upper Dose)|
938265|NCT00985439|B1|Baseline|Diclofenac Test (Lower Dose)|
938266|NCT00985439|P4|Participant Flow|Placebo|
938267|NCT00985439|P3|Participant Flow|Celecoxib 400 mg|
938268|NCT00985439|P2|Participant Flow|Diclofenac Test (Upper Dose)|
938269|NCT00985439|P1|Participant Flow|Diclofenac Test (Lower Dose)|
938270|NCT00985439|O4|Outcome|Placebo|
938271|NCT00985439|O3|Outcome|Celecoxib 400 mg|
938272|NCT00985439|O2|Outcome|Diclofenac Test (Upper Dose)|35-mg
938273|NCT00985439|O1|Outcome|Diclofenac Test (Lower Dose)|18-mg
938274|NCT00985439|E4|Reported Event|Placebo|
938275|NCT00985439|E3|Reported Event|Celecoxib 400 mg|
938276|NCT00985439|E2|Reported Event|Diclofenac Test (Upper Dose)|
938277|NCT00985439|E1|Reported Event|Diclofenac Test (Lower Dose)|
938423|NCT00984815|E1|Reported Event|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
938278|NCT00985257|B1|Baseline|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
938279|NCT00985257|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
938280|NCT00985257|O1|Outcome|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
938281|NCT00985257|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes (or parents/guardians, if applicable)and healthcare professionals (HCPs) use a new blood glucose monitoring system. Subjects were 4 to 24 years of age with type 1 and type 2 diabetes.
938282|NCT00985231|B3|Baseline|Total|Total of all reporting groups
938283|NCT00985231|B2|Baseline|SofLens59 Contact Lens|
938284|NCT00985231|B1|Baseline|PureVision Multi-Focal Contact Lenses|
938285|NCT00985231|P2|Participant Flow|SofLens59 Contact Lens|
938286|NCT00985231|P1|Participant Flow|PureVision Multi-Focal Contact Lenses|
938287|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
938288|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
938289|NCT00985231|O2|Outcome|SofLens59 Contact Lens|
938290|NCT00985231|O1|Outcome|PureVision Multi-Focal Contact Lenses|
938291|NCT00985231|E2|Reported Event|SofLens59 Contact Lens|
938292|NCT00985231|E1|Reported Event|PureVision Multi-Focal Contact Lenses|
938293|NCT00985192|B1|Baseline|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938294|NCT00985192|P1|Participant Flow|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938295|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938296|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938297|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938298|NCT00985192|O1|Outcome|Everolimus|"Patients receive oral everolimus once daily on days 1-14. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity~everolimus~laboratory biomarker analysis"
938314|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
938315|NCT00985166|O3|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
938316|NCT00985166|O2|Outcome|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
938317|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
938318|NCT00985166|O2|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
938319|NCT00985166|O1|Outcome|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
938320|NCT00985166|E3|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 1.
938321|NCT00985166|E2|Reported Event|M-M-R™ II + Placebo|M-M-R™ II + placebo administered concomitantly at separate injection sites on Day 1.
938322|NCT00985166|E1|Reported Event|ProQuad™ + Placebo|ProQuad™ (measles, mumps, rubella, and varicella vaccine) + placebo administered concomitantly at separate injection sites on Day 1.
938323|NCT00985153|B5|Baseline|Total|Total of all reporting groups
938324|NCT00985153|B4|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938325|NCT00985153|B3|Baseline|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938326|NCT00985153|B2|Baseline|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938327|NCT00985153|B1|Baseline|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938328|NCT00985153|P4|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938329|NCT00985153|P3|Participant Flow|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938330|NCT00985153|P2|Participant Flow|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938331|NCT00985153|P1|Participant Flow|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938332|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938333|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938424|NCT00984698|B3|Baseline|Total|Total of all reporting groups
938334|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938335|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938336|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938337|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938338|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938339|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938340|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938341|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938342|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938343|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938344|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938345|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938346|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938347|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938348|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938349|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938350|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938351|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938352|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938353|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938354|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938355|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938356|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938357|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938358|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938359|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938360|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938361|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938362|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938363|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938364|NCT00985153|O4|Outcome|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938365|NCT00985153|O3|Outcome|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938366|NCT00985153|O2|Outcome|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938367|NCT00985153|O1|Outcome|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938368|NCT00985153|E4|Reported Event|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
938369|NCT00985153|E3|Reported Event|ProQuad™ Lot 3|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 3 = ProQuad™ containing a varicella dose of 4.73 log10 PFU/0.5 mL.
938370|NCT00985153|E2|Reported Event|ProQuad™ Lot 2|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 2 administered on Day 0. ProQuad™ Lot 2 = ProQuad™ containing a varicella dose of 4.61 log10 PFU/0.5 mL.
938371|NCT00985153|E1|Reported Event|ProQuad™ Lot 1|ProQuad™ (measles, mumps, rubella, and varicella vaccine) Lot 1 administered on Day 0. ProQuad™ Lot 1 = ProQuad™ containing a varicella dose of 4.40 log10 PFU/0.5 mL.
938372|NCT00985140|B1|Baseline|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy.
938373|NCT00985140|P1|Participant Flow|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
938374|NCT00985140|O1|Outcome|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
938375|NCT00985140|E1|Reported Event|12 Gy TSEBT|Total skin electron beam therapy will be administered in the Department of Radiation Oncology according to the Stanford six-field technique. Patients will receive a planned total skin dose of 12 Gy fractionated at 2 Gy/cycle (each cycle requiring 2 days of treatment) 4 days each week, for 3 weeks. Discrete tumors may receive additional “boost” treatment not to exceed 12 Gy. .
938376|NCT00985114|B3|Baseline|Total|Total of all reporting groups
938377|NCT00985114|B2|Baseline|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
938378|NCT00985114|B1|Baseline|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
938379|NCT00985114|P2|Participant Flow|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
938380|NCT00985114|P1|Participant Flow|EndoBarrier Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
938381|NCT00985114|O2|Outcome|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
938382|NCT00985114|O1|Outcome|Device|"EndoBarrier~EndoBarrier: EndoBarrier implant"
938383|NCT00985114|E2|Reported Event|Diet + Lifestyle Counseling|"Multidisciplinary lifestyle and nutritional counseling~Diet + Lifestyle Counseling: Multidisciplinary lifestyle and nutritional counseling"
938400|NCT00984867|P1|Participant Flow|Placebo|Placebo plus sitagliptin alone or in combination with metformin
938401|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
938402|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
938403|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
938404|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
938405|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
938406|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
938407|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
938408|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
938409|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
938410|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
938411|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Full analysis set.
938412|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Full analysis set.
938413|NCT00984867|O2|Outcome|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin
938414|NCT00984867|O1|Outcome|Placebo|Placebo plus sitagliptin alone or in combination with metformin
938415|NCT00984867|E2|Reported Event|Dapagliflozin|Dapagliflozin 10 mg plus sitagliptin alone or in combination with metformin. Safety analysis set.
938416|NCT00984867|E1|Reported Event|Placebo|Placebo plus sitagliptin alone or in combination with metformin. Safety analysis set.
938417|NCT00984815|B1|Baseline|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
938418|NCT00984815|P1|Participant Flow|HZT-501|Open-label treatment with HZT-501(ibuprofen 800 mg/famotidine 26.6 mg) tablets. All doses of study drug will be self-administered orally 3 times daily (TID), for up to 54 weeks.
938419|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
938420|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
938421|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
938422|NCT00984815|O1|Outcome|HZT-501|Open-label treatment with HZT-501 (ibuprofen 800 mg/famotidine 26.6 mg) tablets self-administered orally three times daily (TID) for up to 54 weeks.
938851|NCT00983918|E3|Reported Event|Isoflurane|General Anesthesia with Isoflurane
938425|NCT00984698|B2|Baseline|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
938426|NCT00984698|B1|Baseline|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
938427|NCT00984698|P2|Participant Flow|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
938428|NCT00984698|P1|Participant Flow|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
938429|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
938430|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
938431|NCT00984698|O2|Outcome|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
938507|NCT00984594|B2|Baseline|Primary|CR Plug will be placed in the site of the primary injury
940879|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
938432|NCT00984698|O1|Outcome|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
938433|NCT00984698|E2|Reported Event|Present Centered Group Therapy|PCGT includes education about the typical symptoms and features associated with PTSD and MDD, with a focus on how these symptoms affect interpersonal relationships. It uses the group format to decrease isolation, normalize symptoms, and provide the experience of giving and receiving support. Some relaxation training is provided early in therapy. There is no discussion of past traumatic events.
938434|NCT00984698|E1|Reported Event|Cognitive Behavioral Social Rhythm Group Therapy|CBSRT is designed to improve mood and sleep by stabilizing social rhythms, increasing exposure to ambient light, changing dysfunctional bed/bedtime associations, activating the imagery system by changing nightmare content, and challenging dysfunctional automatic thoughts that might contribute to behavioral inactivation and nonadherence to the therapy protocol. There is no discussion of past traumatic events.
938435|NCT00984659|B5|Baseline|Total|Total of all reporting groups
938436|NCT00984659|B4|Baseline|Albuterol and/or Ipratropium: Run-in Failure|Participants who entered the 2-week Run-in Period, during which they were permitted to use albuterol and/or ipratropium as rescue medication, but then failed to be randomized, or were randomized but did not receive a dose of study medication
938437|NCT00984659|B3|Baseline|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID
938438|NCT00984659|B2|Baseline|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
938439|NCT00984659|B1|Baseline|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
938440|NCT00984659|P4|Participant Flow|FSC 250/50 mcg: Double-blind Treatment Period|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
938441|NCT00984659|P3|Participant Flow|SAL 50 mcg: Double-blind Treatment Period|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
938442|NCT00984659|P2|Participant Flow|Placebo: Double-blind Treatment Period|Matching placebo via DISKUS, administered as one inhalation twice daily (BID) during the 6-week Double-blind Treatment Period
938443|NCT00984659|P1|Participant Flow|Albuterol and/or Ipratropium: Run-in Period|Participants were permitted to use albuterol and/or ipratropium as rescue medication during the 2-week Run-in Period
938444|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938445|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938664|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938446|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938447|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938448|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938449|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938450|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938451|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938452|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938453|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938454|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938455|NCT00984659|O1|Outcome|MITT Population: 6-Week Treatment Period|Participants randomized to receive FSC 250/50 mcg BID, SAL 50 mcg BID, or placebo BID for the 6-week Treatment Period comprising the MITT Population
938456|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938457|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938458|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938459|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938460|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938461|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938462|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938463|NCT00984659|O1|Outcome|All Participants: 2-week Run-in Period|All participants in the 2-week Run-in Period. Participants were permitted to use albuterol and/or ipratropium as rescue medication during this period.
938464|NCT00984659|E3|Reported Event|FSC 250/50 mcg|Fluticasone propionate and salmeterol xinafoate fixed dose combination product (FSC) 250/50 mcg per inhalation via DISKUS, administered as one inhalation BID during the 6-week Double-blind Treatment Period
938465|NCT00984659|E2|Reported Event|SAL 50 mcg|Salmeterol xinafoate (SAL) 50 micrograms (mcg) per inhalation via DISKUS, administered as one inhalation BID
938466|NCT00984659|E1|Reported Event|Placebo|Matching placebo via DISKUS, administered as one inhalation twice daily (BID)
938467|NCT00984620|B3|Baseline|Total|Total of all reporting groups
938468|NCT00984620|B2|Baseline|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938469|NCT00984620|B1|Baseline|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938470|NCT00984620|P2|Participant Flow|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938471|NCT00984620|P1|Participant Flow|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938530|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
938703|NCT00984204|E1|Reported Event|Treatment Arm|
938472|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938473|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938474|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938475|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938476|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938477|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938478|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938508|NCT00984594|B1|Baseline|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
938509|NCT00984594|P2|Participant Flow|Primary|CR Plug will be placed in the site of the primary injury.
938510|NCT00984594|P1|Participant Flow|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
938479|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938480|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938481|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938482|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938483|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938484|NCT00984620|O2|Outcome|Faldaprevir 120mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938573|NCT00984308|O2|Outcome|Control|
938485|NCT00984620|O1|Outcome|Faldaprevir 120mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938486|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938487|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938488|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938489|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938490|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938491|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938511|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
938512|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
938513|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
938492|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938493|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938494|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938495|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938496|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938497|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938498|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938499|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938500|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938501|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938502|NCT00984620|O2|Outcome|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV). Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938503|NCT00984620|O1|Outcome|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks. Patients who did not show an extended early virological response (eRVR) continued treatment with PegIFN/RBV alone for a total of 24 to 48 weeks.
938504|NCT00984620|E2|Reported Event|Faldaprevir 120 mg (24 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 24 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV).
938505|NCT00984620|E1|Reported Event|Faldaprevir 120 mg (12 Weeks)|Patients received Faldaprevir (BI201335) 120 mg soft gelatine capsule once daily combined with PegIFN/RBV (Pegylated interferon alpha-2a solution for injection/Ribavirin tablet) for 12 weeks, with a 3 days lead-in phase of PegIFN/RBV (i.e. initiation of Faldaprevir (BI201335) 3 days after first administration of PegIFN/RBV), followed by PegIFN/RBV for additional 12 weeks.
938506|NCT00984594|B3|Baseline|Total|Total of all reporting groups
940880|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
938514|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
938515|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
938516|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
938517|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury.
938518|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site, CR Plug will be placed in the harvest site.
938519|NCT00984594|O2|Outcome|Primary|CR Plug will be placed in the site of the primary injury
938520|NCT00984594|O1|Outcome|Backfill|Autograft will be placed in the primary defect site; CR Plug will be placed in the harvest site
938521|NCT00984594|E2|Reported Event|Primary|Autograft will be placed in primary defect site.
938522|NCT00984594|E1|Reported Event|Backfill|CR-Plug will be placed in harvest site.
938523|NCT00984568|B3|Baseline|Total|Total of all reporting groups
938524|NCT00984568|B2|Baseline|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
938525|NCT00984568|B1|Baseline|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
938526|NCT00984568|P2|Participant Flow|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
938527|NCT00984568|P1|Participant Flow|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
938528|NCT00984568|O2|Outcome|Step-Up|Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2 g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter.
938529|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
938574|NCT00984308|O1|Outcome|Intervention|
938531|NCT00984568|O1|Outcome|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
938532|NCT00984568|E2|Reported Event|Step-Up|"Level 1: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral 5-aminosalicylic acid (5-ASA) 2~g/day. Level 2: Oral prednisolone (40 mg/day or 1 mg/kg/day in the case of non-response) + oral azathioprine (AZA) at a dose of 2.0-2.5 mg/kg/day. Level 3: Infliximab 5 mg/kg at Weeks 0, 2, and 6 and every 8 weeks thereafter."
938533|NCT00984568|E1|Reported Event|Top-Hold|Level 1: Infliximab IV 5 mg/kg at Weeks 0, 2, and 6, and every 8 weeks thereafter. Level 2: Infliximab IV 5 mg/kg every 4 weeks. Level 3: Prednisolone induction + AZA 2.0-2.5 mg/kg/day.
938534|NCT00984542|B1|Baseline|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938535|NCT00984542|P1|Participant Flow|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938536|NCT00984542|O1|Outcome|Bendatmustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938537|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938538|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938539|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938540|NCT00984542|O1|Outcome|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938541|NCT00984542|E1|Reported Event|Bendamustine|Bendamustine 120 mg/m2 of body surface area intravenously on days 1 and 2 of a 21-day treatment cycle for a maximum of six cycles
938542|NCT00984490|B1|Baseline|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
938543|NCT00984490|P1|Participant Flow|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
938544|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery)
938545|NCT00984490|O1|Outcome|Metformin|Metformin: 850 mg orally (PO) twice a day for 7-21 days, discontinued 24-36 hrs prior to surgery
938546|NCT00984490|E1|Reported Event|Metformin|Metformin: 850 mg PO twice a day for 7-21 days (discontinued 24-36 hrs prior to surgery
938547|NCT00984334|B6|Baseline|Total|Total of all reporting groups
938548|NCT00984334|B5|Baseline|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
938549|NCT00984334|B4|Baseline|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
938550|NCT00984334|B3|Baseline|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
938551|NCT00984334|B2|Baseline|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
938552|NCT00984334|B1|Baseline|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
938553|NCT00984334|P5|Participant Flow|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
938554|NCT00984334|P4|Participant Flow|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
938555|NCT00984334|P3|Participant Flow|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
938556|NCT00984334|P2|Participant Flow|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
938557|NCT00984334|P1|Participant Flow|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
938558|NCT00984334|O5|Outcome|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
938559|NCT00984334|O4|Outcome|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
938560|NCT00984334|O3|Outcome|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
938561|NCT00984334|O2|Outcome|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
938562|NCT00984334|O1|Outcome|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
938563|NCT00984334|E5|Reported Event|Naloxone SR 5mg Capsules|"Naloxone SR 5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 5 mg capsules :"
938564|NCT00984334|E4|Reported Event|Naloxone SR 20 mg Capsules|"Two Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 20mg capsules :"
938565|NCT00984334|E3|Reported Event|Naloxone SR 2.5 mg Capsules|"Naloxone SR 2.5 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 2.5 mg capsules :"
938566|NCT00984334|E2|Reported Event|Naloxone SR 10mg Capsules|"Naloxone SR 10 mg capsules once daily for three weeks then twice daily for three weeks.~Naloxone SR 10 mg capsules :"
938567|NCT00984334|E1|Reported Event|Capsules With no Active Drug|"Placebo capsules once daily for three weeks then twice daily for three weeks.~Placebo :"
938568|NCT00984308|B3|Baseline|Total|Total of all reporting groups
938569|NCT00984308|B2|Baseline|Control|
938570|NCT00984308|B1|Baseline|Intervention|
938571|NCT00984308|P2|Participant Flow|Control|The control group received usual clinical care which may include receipt of sleep diagnostic and therapeutic services
938572|NCT00984308|P1|Participant Flow|Intervention|The intervention group received unattended polysomnography and auto-titrating CPAP if sleep apnea was diagnosed
938582|NCT00984295|B3|Baseline|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938583|NCT00984295|B2|Baseline|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938584|NCT00984295|B1|Baseline|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938585|NCT00984295|P3|Participant Flow|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938586|NCT00984295|P2|Participant Flow|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938587|NCT00984295|P1|Participant Flow|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938588|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938589|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938724|NCT00984139|B1|Baseline|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938590|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938591|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938592|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938593|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938594|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938595|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938596|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938597|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938598|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938599|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938600|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938601|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938602|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938603|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938604|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938605|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938606|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938607|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938608|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938628|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938609|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938610|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938611|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938612|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938613|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938614|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938615|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938616|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938617|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938618|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938619|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938620|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938621|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938622|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938623|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938624|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938625|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938626|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938627|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938722|NCT00984165|E2|Reported Event|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
940881|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
938629|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938630|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938631|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938632|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938633|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938634|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938635|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938636|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938637|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938638|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938639|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938640|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938641|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938642|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938643|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938644|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938645|NCT00984295|O3|Outcome|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938646|NCT00984295|O2|Outcome|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938647|NCT00984295|O1|Outcome|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938723|NCT00984165|E1|Reported Event|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
939126|NCT00983281|B1|Baseline|Hextend|Patients that received Hextend as part of their resuscitation fluid.
938648|NCT00984295|E3|Reported Event|Control Group|Control Group - M-M-R™ II (measles, mumps, and rubella vaccine) and VARIVAX™ (varicella virus vaccine) administered concomitantly at separate injection sites on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938649|NCT00984295|E2|Reported Event|Nonconcomitant Group|Nonconcomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 0 and TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) and COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 42.
938650|NCT00984295|E1|Reported Event|Concomitant Group|Concomitant Group - ProQuad™ (measles, mumps, rubella, and varicella vaccine) + TRIPEDIA™ (diphtheria and tetanus toxoids and acellular pertussis vaccine) + COMVAX™ (haemophilus b conjugate and hepatitis B vaccine) administered concomitantly at separate injection sites on Day 0.
938651|NCT00984282|B3|Baseline|Total|Total of all reporting groups
938652|NCT00984282|B2|Baseline|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle.
938653|NCT00984282|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
938654|NCT00984282|P2|Participant Flow|DB Placebo First, Then Option of OL Sorafenib Treatment|Double-blind period: participants received matching placebo tablets orally twice daily, 28 days comprised a cycle. Open-label (OL) period: participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle.
938655|NCT00984282|P1|Participant Flow|DB Sorafenib First, Then Option of OL Sorafenib Treatment|Double-blind period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Open-label (OL) period: Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle.
938656|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938657|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
938658|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938659|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
938660|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938661|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
938662|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938663|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
938704|NCT00984165|B5|Baseline|Total|Total of all reporting groups
951430|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
938665|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
938666|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938667|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
938668|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938669|NCT00984282|O2|Outcome|Placebo|Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle
938670|NCT00984282|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle
938671|NCT00984282|E4|Reported Event|Placebo, Open Label Only (Switch to Sorafenib)|Reporting Group 3: Participants on placebo who switched to sorafenib, received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of open label period to the data cutoff on 31 Aug 20
938672|NCT00984282|E3|Reported Event|Sorafenib, Open Label Only (Sorafenib Continued)|Reporting Group 3: Participants on sorafenib who continued OL sorafenib treat., received sorafenib 400 mg (2 x 200 mg) orally twice daily, 28 days comprise a cycle. Data were collected from the start of OL period to the data cutoff on 31 Aug
938673|NCT00984282|E2|Reported Event|Placebo (Double Blind Only)|Reporting Group 2: Participants received 2 tablets of Sorafenib-matching placebo orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double-blind period.
938674|NCT00984282|E1|Reported Event|Sorafenib (Double Blind Only)|Reporting Group 1: Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (12 hours apart without food), 28 days comprise a cycle. Data were collected from randomization to the end of double blind period
938675|NCT00984256|B3|Baseline|Total|Total of all reporting groups
938676|NCT00984256|B2|Baseline|Control|The six (6) Control volunteers were enrolled in a open label arm and received no treatment prior to malaria challenge.
938677|NCT00984256|B1|Baseline|Malarone|"Thirty (30) subjects were placed in the Malarone (treatment) Arm. The thirty subjects were then randomized into 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge. The groups received treatment as follows:~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
938678|NCT00984256|P2|Participant Flow|Malarone Treatment|"Within the Malarone Arm, thirty volunteers were randomized into the below 5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
938679|NCT00984256|P1|Participant Flow|Control|The six volunteers in control cohort were enrolled as infectivity controls and did not undergo randomization or receive any study drug.
938680|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
938681|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
938682|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
938683|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
938684|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
938685|NCT00984256|O5|Outcome|Prophylaxis Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
938686|NCT00984256|O4|Outcome|Prophylaxis Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
938687|NCT00984256|O3|Outcome|Prophylaxis Group 3|(Group 3)Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
938688|NCT00984256|O2|Outcome|Prophylaxis Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
938689|NCT00984256|O1|Outcome|Prophylaxis Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
938690|NCT00984256|O6|Outcome|Control|Six volunteers for the control cohort were enrolled as an infectivity control and did not undergo drug dosing.
938691|NCT00984256|O5|Outcome|Treatment Group 5|(Group 5) Malarone 4 tablets (1000/400 mg) orally administered once 7 days prior to challenge
938692|NCT00984256|O4|Outcome|Treatment Group 4|(Group 4) Malarone 2 tablets (500/200 mg) orally administered once 7 days prior to challenge
938693|NCT00984256|O3|Outcome|Treatment Group 3|(Group 3) Malarone 1 tablets (250/100 mg) orally administered once 7 days prior to challenge
938694|NCT00984256|O2|Outcome|Treatment Group 2|(Group 2) Malarone 1 tablet (250/100 mg) orally administered once on day 4 after challenge
938695|NCT00984256|O1|Outcome|Treatment Group 1|(Group 1) Malarone 1 tablet (250/100 mg) orally administered once 1 day prior to challenge
938696|NCT00984256|E2|Reported Event|Control|no malarone prophylaxis received
938697|NCT00984256|E1|Reported Event|Drug|"Partially randomized, double-blind, placebo-controlled trial using a human Plasmodium falciparum challenge to evaluate malaria chemoprophylaxis of Malarone in 36 healthy adults. Subjects were enrolled in 1 of 2 cohorts based on subject preference. Thirty subjects were placed in the prophylaxis cohort (Cohort 1) and 6 subjects were placed in the control cohort (Cohort 2)~5 treatment groups, each group receiving Malarone tablet(s) (250/100mg)prior to challenge.~Group 1 - 1 tablet 1 day before challenge Group 2 - 1 tablet 4 days before challenge Group 3 - 1 tablet 7 days before challenge Group 4 - 2 tablets 7 days before challenge Group 5 - 4 tablets 7 days before challenge"
938698|NCT00984204|B1|Baseline|Treatment Arm|
938699|NCT00984204|P1|Participant Flow|Treatment Arm|
938700|NCT00984204|O1|Outcome|Treatment Arm|
938701|NCT00984204|O1|Outcome|Treatment Arm|
938702|NCT00984204|O1|Outcome|Treatment Arm|
938707|NCT00984165|B2|Baseline|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
938708|NCT00984165|B1|Baseline|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
938709|NCT00984165|P4|Participant Flow|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
938710|NCT00984165|P3|Participant Flow|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
938711|NCT00984165|P2|Participant Flow|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
938712|NCT00984165|P1|Participant Flow|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
938713|NCT00984165|O4|Outcome|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
938714|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
938715|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
938716|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
938717|NCT00984165|O3|Outcome|Donor Lymphocyte Infusion-Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
938718|NCT00984165|O2|Outcome|Radiation/No Donor Lymphocyte Infusion|Subjects will receive radiation (single, 8-Gy fraction to the maximum number of lesions).
938719|NCT00984165|O1|Outcome|Donor Lymphocyte Infusion/Radiation|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 1 after radiation (single, 8-Gy fraction to the maximum number of lesions).
938720|NCT00984165|E4|Reported Event|Donor Lymphocyte Infusion - Donor|Healthy subjects who donated lymphocytes for infusion on a treatment Arm.
938721|NCT00984165|E3|Reported Event|Donor Lymphocyte Infusion - Control|Subjects will receive a unmanipulated donor lymphocyte infusion (DLI) on Day 0.
938725|NCT00984139|P1|Participant Flow|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938726|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938727|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938728|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938729|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938730|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938731|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938732|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938733|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938734|NCT00984139|O1|Outcome|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938735|NCT00984139|E1|Reported Event|Engerix-B Group|Subjects who were vaccinated with 3 doses of Engerix-B in infancy and who received a single challenge dose of Engerix-B , intramuscularly in the deltoid region of the non-dominant arm, at 12-13 years of age (Day 0).
938736|NCT00984061|B1|Baseline|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
938737|NCT00984061|P1|Participant Flow|Colchicine Alone / With Clarithromycin|[All subjects received each of the study treatments.] Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period. On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
938738|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
938739|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
938740|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
938741|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
938742|NCT00984061|O2|Outcome|Colchicine With Clarithromycin|On Day 22, subjects began taking one 250 mg clarithromycin tablet every 12 hours at 8:00 a.m. and 8:00 p.m. for 7 days without regard to meals. Then, on Day 29, each subject received one colchicine 0.6 mg tablet along with final dose of 250 mg clarithromycin at 9:00 a.m. after an overnight fast of at least 10 hours.
938743|NCT00984061|O1|Outcome|Colchicine Alone|Each subject received one colchicine 0.6 mg tablet on Day 1 at 9:00 a.m. after an overnight fast of at least 10 hours, followed by a 21 day washout period.
938744|NCT00984061|E3|Reported Event|Colchicine With Clarithromycin|On the morning of Day 29 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with the last dose of clarithromycin.
938745|NCT00984061|E2|Reported Event|Clarithromycin Alone|On the evening of Day 22, subjects began taking (on an outpatient basis) one tablet of clarithromycin 250 mg every 12 hours for 7 days without regard to meals.
938746|NCT00984061|E1|Reported Event|Colchicine Alone|On the morning of Day 1 after a fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg.
938747|NCT00984022|B3|Baseline|Total|Total of all reporting groups
938748|NCT00984022|B2|Baseline|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
938749|NCT00984022|B1|Baseline|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
938750|NCT00984022|P2|Participant Flow|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
939127|NCT00983281|P2|Participant Flow|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
938751|NCT00984022|P1|Participant Flow|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
938752|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
938753|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
938754|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
938755|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
938756|NCT00984022|O2|Outcome|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
938757|NCT00984022|O1|Outcome|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
938758|NCT00984022|E2|Reported Event|Aquacel Dressing|Aquacel dressing for cutaneous abscess. Aquacel Ag ribbons (Conva Tec Ltd., Skillman, NJ). Placed in the cavity after incision and drainage.
938759|NCT00984022|E1|Reported Event|Iodoform Dressing|Iodoform dressing for cutaneous abscess. Iodoform packing strips provided by Kendall, Curity, Tyco Healthcare Group LP, Mansfield, MA. Placed in the cavity after incision and drainage.
938760|NCT00984009|B1|Baseline|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
938761|NCT00984009|P1|Participant Flow|Colchicine Alone / With Grapefruit Juice|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
938762|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
938763|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938764|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
938765|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938852|NCT00983918|E2|Reported Event|Sevoflurane|General Anesthesia with Sevoflurane
938766|NCT00984009|O2|Outcome|Colchicine With Grapefruit Juice|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals. Then, on Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
938767|NCT00984009|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938768|NCT00984009|E3|Reported Event|Colchicine With Grapefruit Juice|On Day 18, each subject received both one 0.6 mg colchicine tablet and one 240 ml serving of grapefruit juice at 7:15 a.m. after an overnight fast. A final 240 ml serving of grapefruit juice was administered at 7:15 p.m. that evening.
938769|NCT00984009|E2|Reported Event|Grapefruit Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of grapefruit juice twice daily, at 7:15 a.m. and 7:15 p.m, without regard to meals.
938770|NCT00984009|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938771|NCT00983983|B4|Baseline|Total|Total of all reporting groups
938772|NCT00983983|B3|Baseline|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938773|NCT00983983|B2|Baseline|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938774|NCT00983983|B1|Baseline|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
939128|NCT00983281|P1|Participant Flow|Hextend|Patients that received Hextend as part of their resuscitation fluid.
938775|NCT00983983|P3|Participant Flow|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938776|NCT00983983|P2|Participant Flow|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938777|NCT00983983|P1|Participant Flow|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938778|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938779|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938780|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938781|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938782|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938783|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938784|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938785|NCT00983983|O2|Outcome|High Calorie|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938853|NCT00983918|E1|Reported Event|Desflurane|General Anesthesia with Desflurane
938786|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938787|NCT00983983|O3|Outcome|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938788|NCT00983983|O2|Outcome|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938789|NCT00983983|O1|Outcome|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938790|NCT00983983|E3|Reported Event|Control|"Control diet: Jevity 1.0~Jevity 1.0: Jevity 1.0: Control tube feed. Subjects will receive 1.0 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938791|NCT00983983|E2|Reported Event|High Calorie/High Carbohydrate|"High calorie diet: Jevity 1.5~Jevity 1.5: Jevity 1.5: Tube feed containing 1.5 calories/ml of which 29.4% are from fat. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938792|NCT00983983|E1|Reported Event|High Fat/High Calorie|"High fat/high calorie diet: Oxepa~Oxepa: Oxepa: Tube feed containing 1.5 calories/ml of which 55% calories are from fat, including eicosapentaenoic acid and gamma-linolenic acid. Subjects will receive 1.25 times their daily caloric requirements based on their measured resting energy expenditure. Subjects will receive 4 months of tube feeds and be followed for an additional 1 month to measure adverse events and tolerability."
938793|NCT00983957|B1|Baseline|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938794|NCT00983957|P1|Participant Flow|Ortho Tri-Cyclen + Daclatasvir|Participants received sequentially Treatment A: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938795|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938796|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938797|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938798|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938799|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938800|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938801|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938802|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938803|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938804|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938805|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938806|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938807|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938808|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938809|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938810|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938959|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938811|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938812|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938813|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938814|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938815|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938816|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938817|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938818|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938819|NCT00983957|O2|Outcome|Ortho Tri-Cyclen + Daclatasvir|Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 concomitantly with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938820|NCT00983957|O1|Outcome|Ortho Tri-Cyclen|Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56.
938821|NCT00983957|E6|Reported Event|Ortho Tri-Cyclen + Daclatasvir Days 68-77|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67 along with daclatasvir two tablets of 30-mg, orally, once daily from Day 68 to 77.
938822|NCT00983957|E5|Reported Event|Ortho Tri-Cyclen Days 57-67|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 67.
938823|NCT00983957|E4|Reported Event|Ortho Tri-Cyclen Days 47-56|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 47 to 56.
938824|NCT00983957|E3|Reported Event|Ortho Tri-Cyclen Days 29-46|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 46.
938825|NCT00983957|E2|Reported Event|Ortho Tri-Cyclen Days 1-28|Participants received Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily up to Day 28.
938826|NCT00983957|E1|Reported Event|All Treated Participants|Participants received sequentially Treatment A: Ortho Tri-Cyclen (OTC) fixed dose combination tablet, orally, once daily up to Day 28, Treatment B: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 29 to 56 and Treatment C: Ortho Tri-Cyclen fixed dose combination tablet, orally, once daily from Day 57 to 77 along with daclatasvir, two tablets of 30-mg, orally, once daily from Day 68 to 77.
938827|NCT00983931|B1|Baseline|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
938828|NCT00983931|P1|Participant Flow|Colchicine Alone / With Cyclosporine|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. Then, on Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
938829|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
938830|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938831|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
938832|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938833|NCT00983931|O2|Outcome|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
938834|NCT00983931|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938835|NCT00983931|E2|Reported Event|Colchicine With Cyclosporine|On Day 15, each subject received both one 0.6 mg colchicine tablet and one 100 mg cyclosporine capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
938836|NCT00983931|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
938837|NCT00983918|B5|Baseline|Total|Total of all reporting groups
938838|NCT00983918|B4|Baseline|Propofol|General Anesthesia with Propofol
938839|NCT00983918|B3|Baseline|Isoflurane|General Anesthesia with Isoflurane
938840|NCT00983918|B2|Baseline|Sevoflurane|General Anesthesia with Sevoflurane
938841|NCT00983918|B1|Baseline|Desflurane|General Anesthesia with Desflurane
938842|NCT00983918|P4|Participant Flow|Propofol|General Anesthesia with Propofol
938843|NCT00983918|P3|Participant Flow|Isoflurane|General Anesthesia with Isoflurane
938844|NCT00983918|P2|Participant Flow|Sevoflurane|General Anesthesia with Sevoflurane
938845|NCT00983918|P1|Participant Flow|Desflurane|General Anesthesia with Desflurane
938846|NCT00983918|O4|Outcome|Propofol|General Anesthesia with Propofol
938847|NCT00983918|O3|Outcome|Isoflurane|General Anesthesia with Isoflurane
938848|NCT00983918|O2|Outcome|Sevoflurane|General Anesthesia with Sevoflurane
938849|NCT00983918|O1|Outcome|Desflurane|General Anesthesia with Desflurane
938854|NCT00983905|B1|Baseline|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
938855|NCT00983905|P1|Participant Flow|Theophylline Alone / With Colchicine (at Steady State)|[All subjects received each of the study treatments.] Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45am after an overnight fast of at least 10 hours, followed by a washout period of 4 days. On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45am and 7:45pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
938856|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
938857|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
938858|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
951302|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
938859|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
938860|NCT00983905|O2|Outcome|Theophylline With Colchicine (at Steady-state)|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals. Then, on Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
938861|NCT00983905|O1|Outcome|Theophylline Alone|On Day 1, each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
938862|NCT00983905|E3|Reported Event|Theophylline With Steady-state Colchicine|On Day 19, each subject received both a single dose of theophylline elixer (80 mg/15 ml concentrate) and one 0.6 mg colchicine tablet at 7:45 am after an overnight fast of at least 10 hours. (They also received the final dose of one 0.6 mg colchicine tablet at 7:45 pm.)
938863|NCT00983905|E2|Reported Event|Colchicine Alone|On Days 5 to 18, each subject received one 0.6 mg colchicine tablet twice daily at 7:45 am and 7:45 pm without regard to meals.
938864|NCT00983905|E1|Reported Event|Theophylline Alone|Each subject received a single 300 mg dose of theophylline elixer (80 mg/15 ml concentrate) on Day 1 at 7:45 am after an overnight fast of at least 10 hours, followed by a washout period of 4 days.
938865|NCT00983892|B3|Baseline|Total|Total of all reporting groups
938866|NCT00983892|B2|Baseline|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
938867|NCT00983892|B1|Baseline|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
938868|NCT00983892|P2|Participant Flow|CarePartners -|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
938869|NCT00983892|P1|Participant Flow|CarePartners +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
938870|NCT00983892|O2|Outcome|Control|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
938871|NCT00983892|O1|Outcome|CarePartners Intervention +|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
938872|NCT00983892|E2|Reported Event|CarePartners-|Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive nothing.
938873|NCT00983892|E1|Reported Event|CarePartners+|"Patients receive automated telephonic symptom assessment and symptom management advice; caregivers receive access to a Web site that updates them on patient's symptoms and provides tailored problem solving advice.~Caregiver website: Website receives patient symptom assessment data from IVR and provides caregivers with weekly updates on patient status, allowing caregivers to access tailored symptom management advice and formulate an action plan."
938874|NCT00983853|B7|Baseline|Total|Total of all reporting groups
939421|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
938875|NCT00983853|B6|Baseline|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938876|NCT00983853|B5|Baseline|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938877|NCT00983853|B4|Baseline|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938878|NCT00983853|B3|Baseline|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938879|NCT00983853|B2|Baseline|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938880|NCT00983853|B1|Baseline|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938881|NCT00983853|P6|Participant Flow|Part B: ATV/R-based HAART + Pbo/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
938904|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938941|NCT00983645|B2|Baseline|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
938882|NCT00983853|P5|Participant Flow|Part B: ATV/R-based HAART + T/PR|"Drug: ritonavir-boosted atazanavir, tenofovir disoproxil fumarate, and emtricitabine or lamivudine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
938883|NCT00983853|P4|Participant Flow|Part B: EFV-based HAART + Pbo/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
938884|NCT00983853|P3|Participant Flow|Part B: EFV-based HAART + T/PR|"Drug: efavirenz, tenofovir disoproxil fumarate, and emtricitabine~Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
938885|NCT00983853|P2|Participant Flow|Part A: Pbo/PR|"Drug: placebo tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
938886|NCT00983853|P1|Participant Flow|Part A: T/PR|"Drug: telaprevir tablet, oral, 750 mg, q8h, 12 weeks~Biological: peginterferon alfa-2a subcutaneous injection, 180 μg, once weekly, 48 weeks~Drug: ribavirin (fixed dose) tablet, oral, 800 mg, b.i.d., 48 weeks~Drug: ribavirin (weight-based dose) tablet, oral, 1000 mg for subjects weighing <75 kg or 1200 mg for subjects weighing ≥75 kg, b.i.d., 48 weeks~The dose of ribavirin used (fixed versus weight-based) was region dependent."
938887|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938888|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir(ATV/r)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938889|NCT00983853|O2|Outcome|Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938890|NCT00983853|O1|Outcome|T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz(EFV)-based highly active antiretroviral therapy(HAART) for the entire 48 week study.
938891|NCT00983853|O2|Outcome|ATV/R-based (Test, N=13) vs No HAART (Reference, N=7)|
938892|NCT00983853|O1|Outcome|EFV-based (Test, N=15) vs No HAART (Reference, N=7)|
938893|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938926|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938894|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938895|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938896|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938897|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938898|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938899|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938900|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938901|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938902|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938903|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938940|NCT00983645|B3|Baseline|Total|Total of all reporting groups
938905|NCT00983853|O6|Outcome|Part B: ATV/R-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938906|NCT00983853|O5|Outcome|Part B: ATV/R-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant ritonavir-boosted atazanavir (ATV/r)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938907|NCT00983853|O4|Outcome|Part B: EFV-based HAART + Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938908|NCT00983853|O3|Outcome|Part B: EFV-based HAART + T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects receiving concomitant efavirenz (EFV)-based highly active antiretroviral therapy (HAART) for the entire 48 week study.
938909|NCT00983853|O2|Outcome|Part A: Pbo/PR|Placebo plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938910|NCT00983853|O1|Outcome|Part A: T/PR|Telaprevir plus peginterferon alfa-2a and ribavirin for 12 weeks, followed by 36 weeks of peginterferon alfa-2a and ribavirin. Subjects not receiving HAART.
938911|NCT00983853|E2|Reported Event|Total PR|Pooled PR from Part A and Part B
938912|NCT00983853|E1|Reported Event|T/PR|Pooled T/PR from Part A and Part B
938913|NCT00983827|B1|Baseline|Aquatic Treadmill Training|
938914|NCT00983827|P1|Participant Flow|Aquatic Treadmill Training|Aquatic treadmill training (ATT) is a pool-based treadmill training that combines the three concepts of unweighting the body, treadmill training, and the resistance effects of water into one modality.
938915|NCT00983827|O1|Outcome|Aquatic Treadmill Training|
938916|NCT00983827|E1|Reported Event|Aquatic Treadmill Training|
938917|NCT00983801|B1|Baseline|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938918|NCT00983801|P1|Participant Flow|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938919|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938920|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938921|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938922|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938923|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938924|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938925|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
951431|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
938927|NCT00983801|O1|Outcome|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938928|NCT00983801|E1|Reported Event|Ixabepilone 40 mg/m^2 IV|ixabepilone 40 mg/m^2 intravenous (IV), every 21 days, up to 8 cycles or until disease progression or development of intolerable toxicity.
938929|NCT00983749|B3|Baseline|Total|Total of all reporting groups
938930|NCT00983749|B2|Baseline|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
938931|NCT00983749|B1|Baseline|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
938932|NCT00983749|P2|Participant Flow|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
938933|NCT00983749|P1|Participant Flow|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
938934|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
938935|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
938936|NCT00983749|O2|Outcome|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
938937|NCT00983749|O1|Outcome|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
938938|NCT00983749|E2|Reported Event|Sham-pressure ECP|Patients receiving sham-pressure ECP received a one-hour treatment of ECP at an inactive pressure, applied at 75mmHg and kept there for the hour while assessments were made.
938939|NCT00983749|E1|Reported Event|Full-pressure ECP|"Patients in the Full-pressure ECP arm received a 1-hour treatment of ECP at full pressure, applied in a tiered, dose-escalating manner up to 300mmHg, while assessments were made."
938942|NCT00983645|B1|Baseline|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
938943|NCT00983645|P2|Participant Flow|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
938944|NCT00983645|P1|Participant Flow|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
938945|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
938946|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
938947|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
938948|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
938949|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
938950|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
938951|NCT00983645|O2|Outcome|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
938952|NCT00983645|O1|Outcome|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
938953|NCT00983645|E2|Reported Event|Prograf|"Prograf is a medication used for the prophylaxis of rejection in allogeneic kidney transplants and may be used concomitantly with adrenal corticosteroids.~Prograf: Tacrolimus (Prograf) starting dose 0.05-0.15 mg/kg PO BID"
938954|NCT00983645|E1|Reported Event|Neoral|"Neoral is a pill indicated for the prophylaxis of organ rejection in kidney transplants~Neoral: Cyclosporine (Neoral) starting dose 3mg/kg PO BID"
938955|NCT00983541|B1|Baseline|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
938956|NCT00983541|P1|Participant Flow|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) : Patients receive 45 Gy (gray) external beam radiation therapy including the primary tumor and regular lymph nodes (25 fractions over 5 weeks). Within 1 month of external beam radiation therapy, patients will have boost treatment of 20 Gy in 4 fractions, via Ir-192 brachytherapy or SBRT (Stereotactic Body Radiation Therapy).~Fluorouracil (5-FU) : 5-FU Injection,USP. This study uses 350 mg/m2/day days 1-5 each week of radiation therapy~Gemcitabine"
938957|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938958|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938960|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938961|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938962|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938963|NCT00983541|O1|Outcome|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938964|NCT00983541|E1|Reported Event|All Patients|"All participants enrolled.~Brachytherapy or SBRT (Stereotactic body radiation therapy) :~Fluorouracil (5-FU) :~Gemcitabine"
938965|NCT00983515|B1|Baseline|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
938966|NCT00983515|P1|Participant Flow|Colchicine Alone / With Ritonavir (at Steady-state)|[All subjects received each of the study treatments.] On Day 1, each subject received one colchicine 0.6 mg tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
938967|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
939044|NCT00983437|E1|Reported Event|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
938968|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
938969|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
938970|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
938971|NCT00983515|O2|Outcome|Colchicine With Ritonavir (at Steady-state)|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
938972|NCT00983515|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
938973|NCT00983515|E3|Reported Event|Colchicine With Steady-state Ritonavir|On Day 19, each subject received both one 0.6 mg colchicine tablet and one 100 mg ritonavir capsule at 7:00 a.m. after an overnight fast. A final dose of ritonavir was administered at 7:00 p.m. that evening.
938974|NCT00983515|E2|Reported Event|Ritonavir Alone|On Days 15 to 18, each subject received one 100 mg ritonavir capsule twice daily at 7:00 a.m. and 7:00 p.m. without regards to meals.
938975|NCT00983515|E1|Reported Event|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:00 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
938976|NCT00983489|B4|Baseline|Total|Total of all reporting groups
938977|NCT00983489|B3|Baseline|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
938978|NCT00983489|B2|Baseline|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
938979|NCT00983489|B1|Baseline|Counselling|counselling: Breast feeding counselling will be done to mothers
938980|NCT00983489|P3|Participant Flow|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
938981|NCT00983489|P2|Participant Flow|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
938982|NCT00983489|P1|Participant Flow|Counselling|counselling: Breast feeding counselling will be done to mothers
938983|NCT00983489|O3|Outcome|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
938984|NCT00983489|O2|Outcome|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
938985|NCT00983489|O1|Outcome|Counselling|counselling: Breast feeding counselling will be done to mothers
938986|NCT00983489|E3|Reported Event|Standard Care|Standard care includes the routine care provided to the neonates as per hospital protocol
938987|NCT00983489|E2|Reported Event|Video Demonstration|Video demonstration to mothers on the advantages of exclusive breast feeding
938988|NCT00983489|E1|Reported Event|Counselling|counselling: Breast feeding counselling will be done to mothers
938989|NCT00983476|B4|Baseline|Total|Total of all reporting groups
938990|NCT00983476|B3|Baseline|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
938991|NCT00983476|B2|Baseline|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
939182|NCT00982735|P1|Participant Flow|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
951432|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
938992|NCT00983476|B1|Baseline|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
938993|NCT00983476|P3|Participant Flow|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
938994|NCT00983476|P2|Participant Flow|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
938995|NCT00983476|P1|Participant Flow|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
938996|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
938997|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
938998|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
938999|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939000|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|"web-based MOVE! SMI~web-based MOVE! SMI: online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
939001|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|"in-person MOVE! SMI~in-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))"
939002|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939003|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939082|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|Subgroup of participants with a score between 13 and 18.
939004|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939005|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939006|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939007|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939008|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939009|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939010|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions the deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939011|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939012|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939013|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939014|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939015|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939016|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939017|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939018|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
939019|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
939020|NCT00983476|O3|Outcome|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939021|NCT00983476|O2|Outcome|Arm 2: Web-based MOVE! SMI|online sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939022|NCT00983476|O1|Outcome|Arm 1: In-person MOVE! SMI|Individual and group in-person sessions that deliver manualized MOVE! curriculum adapted for use with individuals with cognitive deficits (often found in individuals with severe mental illness (SMI))
939023|NCT00983476|E3|Reported Event|Arm 3: Usual Care + Handouts|usual care + educational handouts regarding weight loss
939183|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
939024|NCT00983476|E2|Reported Event|Arm 2: Web-based MOVE! SMI|Web-based MOVE! SMI: online sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits; plus peer coaching
939025|NCT00983476|E1|Reported Event|Arm 1: In-person MOVE! SMI|In-person MOVE! SMI: Individual and group in-person sessions that deliver manualized MOVE! diet and activity curriculum adapted for use with individuals with severe mental illness (SMI), who often have cognitive deficits
939026|NCT00983437|B1|Baseline|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939027|NCT00983437|P1|Participant Flow|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939028|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939029|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939030|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939031|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939032|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939033|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939034|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939035|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939036|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939037|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939038|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939039|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939040|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939041|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939042|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939043|NCT00983437|O1|Outcome|Armodafinil|Armodafinil tablets 150 mg or 250 mg administered orally, once daily in the morning.
939045|NCT00983385|B1|Baseline|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939046|NCT00983385|P1|Participant Flow|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939047|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
939048|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at end of Week 6 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
939049|NCT00983385|O1|Outcome|Tapentadol|Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.
939050|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 12 in PainDetect specific subgroup of participants that entered the maintenance period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
939184|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
951433|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
939051|NCT00983385|O1|Outcome|Tapentadol|"NRS-3 pain intensity values at End of Week 6 in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
939052|NCT00983385|O1|Outcome|Tapentadol|"Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants that entered the titration and optimal dose period.~All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached."
939053|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939054|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939083|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|Subgroup of participants with a score between 0 and 12.
939101|NCT00983359|B1|Baseline|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939055|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939056|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939057|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939058|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939059|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939060|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939061|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939062|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939063|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939064|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939065|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939066|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939067|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939068|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939069|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939070|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939071|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939072|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939073|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939074|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939075|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
939076|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
939077|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
939078|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
939079|NCT00983385|O2|Outcome|Baseline painDETECT Unclear Group|The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
939080|NCT00983385|O1|Outcome|Baseline painDETECT Negative Group|The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
939081|NCT00983385|O3|Outcome|Baseline painDETECT Positive Group|Subgroup of participants with a score between 19 and 38.
939084|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939085|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939086|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939087|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939088|NCT00983385|O1|Outcome|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939089|NCT00983385|E1|Reported Event|Tapentadol|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939090|NCT00983372|B1|Baseline|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
939091|NCT00983372|P1|Participant Flow|Colchicine Alone / With Diltiazem (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days. On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
939092|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
939093|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
939094|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
939095|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
939096|NCT00983372|O2|Outcome|Colchicine With Diltiazem (at Steady-state)|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m. Then, on Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
939097|NCT00983372|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
939098|NCT00983372|E3|Reported Event|Colchicine With Steady-state Diltiazem|On Day 21, each subject received both one 0.6 mg colchicine tablet and one 240 mg diltiazem ER capsule at 7:15 a.m. after an overnight fast of at least 10 hours.
939099|NCT00983372|E2|Reported Event|Diltiazem Alone|On Days 15 to 20, each subject received one 240 mg diltiazem ER capsule at 7:15 a.m.
939100|NCT00983372|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast of at least 10 hours, followed by a washout period of 14 days.
939102|NCT00983359|P1|Participant Flow|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939103|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939104|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939105|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939106|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939107|NCT00983359|O1|Outcome|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939108|NCT00983359|E1|Reported Event|Treatment (Conformal Stereotactic Radiation Therapy)|"Patients undergo conformal stereotatic radiation~Radiation Therapy: Patients undergo conformal stereotatic radiation therapy QD (every day) over 5 days."
939109|NCT00983346|B1|Baseline|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
939110|NCT00983346|P1|Participant Flow|Arm -1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m^2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
939111|NCT00983346|O1|Outcome|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
939112|NCT00983346|E1|Reported Event|Arm 1 Bortezomib|"All participants enrolled.~Bortezomib: Bortezomib will be administered as a 3-5 second bolus IV injection at the dose of 0.7 mg/m2 on days 1, 8, 15, and 22 of each 42 day cycle.~Patients will undergo nine 42-day cycles. At the end of this (day 378), patients will be assessed for bone remodeling changes. Evaluation for toxicities will be evaluated at the beginning of each cycle."
939113|NCT00983294|B1|Baseline|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
951434|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
939114|NCT00983294|P1|Participant Flow|Colchicine Alone / With Azithromycin (at Steady State)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30 am after an overnight fast, followed by a washout period of 14 days. On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250mg azithromycin tablet at 7:30 am after an overnight fast.
939115|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
939116|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
939117|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
939118|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
939119|NCT00983294|O2|Outcome|Colchicine With Azithromycin (at Steady-state)|On Day 15, each subject received two 250 mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250 mg azithromycin tablet daily at 7:30 am without regard to meals on Days 16 to 18. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one 250 mg azithromycin tablet at 7:30 am after an overnight fast.
939120|NCT00983294|O1|Outcome|Colchicine Alone|On Day 1, each subject received one 0.6 mg colchicine tablet at 7:30 am after an overnight fast, followed by a washout period of 14 days.
939121|NCT00983294|E3|Reported Event|Colchicine With Steady-state Azithromycin|On Day 19, each subject received both one 0.6mg colchicine tablet and one 250mg azithromycin tablet at 07:30 after an overnight fast.
939122|NCT00983294|E2|Reported Event|Azithromycin Alone|On Day 15, each subject received two 250mg azithromycin tablets at 7:30 am after an overnight fast, followed by one 250mg azithromycin tablet daily at 07:30 without regard to meals on Days 16 to 18.
939123|NCT00983294|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:30am after an overnight fast, followed by a washout period of 14 days.
939124|NCT00983281|B3|Baseline|Total|Total of all reporting groups
939125|NCT00983281|B2|Baseline|Standard of Care|Patients that received standard of care but no Hextend as part of their resuscitation.
939129|NCT00983281|O2|Outcome|Standard of Care|PAtients that did not receive Hextend as part of their resuscitation fluid.
939130|NCT00983281|O1|Outcome|Hextend|Patients that received Hextend as part of their resuscitation fluid.
939131|NCT00983281|E2|Reported Event|Standard of Care|Patients that received standard resuscitation but no Hextend as part of their resuscitation.
939132|NCT00983281|E1|Reported Event|Hextend|Patients that received Hextend as part of their resuscitation fluid.
939133|NCT00983242|B1|Baseline|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
939134|NCT00983242|P1|Participant Flow|Colchicine Alone, Colchicine With Verapamil HCl ER|All subjects received each of the study treatments. At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period. At 8am on Days 15-18 all subjects received a dose of verapamil hydrochloride extended-release (verapamil HCl ER) 240 mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240 mg.
939135|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
939136|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
939137|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
939138|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
939139|NCT00983242|O2|Outcome|Colchicine With Verapamil HCl ER|At 8am on Days 15-18 subjects were administered verapamil hydrochloride extended release (verapamil HCl ER) 240mg without regard to meals. At 8am on Day 19 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg along with the final dose of verapamil HCl ER 240mg.
939140|NCT00983242|O1|Outcome|Colchicine Alone|At 8am on Day 1 after a fast of at least 10 hours all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
939141|NCT00983242|E3|Reported Event|Colchicine With Verapamil HCl ER|At 8am on Day 19 following a 10 hour fast all subjects received one dose of verapamil HCl ER 240 mg along with one dose of colchicine 0.6 mg.
939142|NCT00983242|E2|Reported Event|Verapamil HCl ER|At 8am on Days 15-18 all subjects received a dose of verapamil HCl ER 240 mg without regard to meals.
939143|NCT00983242|E1|Reported Event|Colchicine Alone|At 8am on Day 1 after a 10 hour fast all subjects received a single dose of colchicine 0.6 mg followed by a 14 day washout period.
940134|NCT00980148|B2|Baseline|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
939144|NCT00983216|B1|Baseline|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
939145|NCT00983216|P1|Participant Flow|Colchicine Alone / With Ketoconazole (at Steady-state)|[All subjects received each of the study treatments.] Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days. On Day 15, subjects began taking one 200 mg ketoconazole tablet twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on Day 19, each subject received both one 0.6 mg colchicine tablet and one ketoconazole 200 mg tablet at 7:15 a.m. after an overnight fast. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
939146|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
939147|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
939148|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
939149|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
939150|NCT00983216|O2|Outcome|Colchicine With Ketoconazole (at Steady-state)|On Day 15, subjects began taking ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals. Then, on the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
939151|NCT00983216|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
939152|NCT00983216|E3|Reported Event|Colchicine With Ketoconazole (at Steady-state)|On the morning of Day 19 after an overnight fast of at least 10 hours, all subjects received a single dose of colchicine 0.6 mg along with ketoconazole 200 mg. A final dose of ketoconazole was administered at 7:15 p.m. that evening.
951303|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
939153|NCT00983216|E2|Reported Event|Ketoconazole Alone|On Day 15 to 18, subjects took ketoconazole 200 mg twice daily at 7:15 a.m. and at 7:15 p.m. without regard to meals.
939154|NCT00983216|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at 7:15 a.m. after an overnight fast, followed by a washout period of 14 days.
939155|NCT00983073|B1|Baseline|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939156|NCT00983073|P1|Participant Flow|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939157|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939158|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939159|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939185|NCT00982735|O1|Outcome|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
939160|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939161|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with either 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939162|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939163|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939164|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939350|NCT00982345|E1|Reported Event|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
940882|NCT00977665|E2|Reported Event|Rasagiline Mesylate|Rasagiline tablet, 1 mg/day for up to 48 weeks.
939165|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939166|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939167|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939168|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939169|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939186|NCT00982735|E1|Reported Event|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
939187|NCT00982657|B5|Baseline|Total|Total of all reporting groups
940135|NCT00980148|B1|Baseline|Azithromycin Arm|Azithromycin 1 gm oral single dose
939170|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939171|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939172|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939173|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939174|NCT00983073|O1|Outcome|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939175|NCT00983073|E1|Reported Event|Tapentadol PR|All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the dose of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939176|NCT00982995|B1|Baseline|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
939177|NCT00982995|P1|Participant Flow|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
939178|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
939179|NCT00982995|O1|Outcome|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
939180|NCT00982995|E1|Reported Event|Palonosetron|"Palonosetron 0.25 mg I.V. bolus~Palonosetron: Palonosetron 0.25 mg as an I.V. bolus. After Palonosetron treatment, no other nausea medication will be given for 2 hours. At that point, if no relief from nausea or vomiting has occured then other anti-nausea medications may be prescribed, and patient will be taken off study. If relief from nausea and vomiting as a result of the Palonosetron occurs, patient will not receive any more anti-nausea medication unless nausea recurs. If it does recur and patient wishes to be retreated with Palonosetron. This may be repeated for a total of 3 doses, as long as it is providing relief."
939181|NCT00982735|B1|Baseline|Telmisartan 40mg or Telmisartan 80 mg Once a Day|Telmisartan (Micardis) 40mg (Telmisartan (Micardis) 80 mg) once a day
939188|NCT00982657|B4|Baseline|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939189|NCT00982657|B3|Baseline|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939190|NCT00982657|B2|Baseline|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939191|NCT00982657|B1|Baseline|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939192|NCT00982657|P4|Participant Flow|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939193|NCT00982657|P3|Participant Flow|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939194|NCT00982657|P2|Participant Flow|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939195|NCT00982657|P1|Participant Flow|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939438|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
939196|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939197|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939198|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939199|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939200|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939201|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939202|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939203|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939204|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939205|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939206|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939207|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6 week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939208|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939209|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939210|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent occurred or investigator's discretion.
939211|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939212|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
939213|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
939214|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity ,withdrawal of consent or investigator's discretion.
939215|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939495|NCT00982033|E2|Reported Event|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
951304|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
939216|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939217|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939218|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939219|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939220|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939221|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939222|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939223|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939224|NCT00982657|O4|Outcome|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939225|NCT00982657|O3|Outcome|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939226|NCT00982657|O2|Outcome|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939227|NCT00982657|O1|Outcome|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939228|NCT00982657|O1|Outcome|All Participants|All participants who received 6 mg/kg, 12mg/kg or 15 mg/kg of CVX-060 intravenous infusion along with oral 50 mg or 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939229|NCT00982657|E4|Reported Event|CVX-060 15 mg/kg + Sunitinib 50 mg|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939230|NCT00982657|E3|Reported Event|CVX-060 12 mg/kg + Sunitinib 50 mg|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939231|NCT00982657|E2|Reported Event|CVX-060 6 mg/kg + Sunitinib 37.5 mg|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly with oral 37.5 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks off (6-week cycle) treatment until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939232|NCT00982657|E1|Reported Event|CVX-060 6 mg/kg + Sunitinib 50 mg|CVX-060 6 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly with oral 50 mg sunitinib capsule once daily up to 4 weeks followed by 2 weeks of off treatment (6-week cycle) until disease progression, unacceptable toxicity, withdrawal of consent or investigator's discretion.
939233|NCT00982644|B3|Baseline|Total|Total of all reporting groups
939234|NCT00982644|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939235|NCT00982644|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939236|NCT00982644|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939237|NCT00982644|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939238|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939239|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939240|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939241|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939242|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939243|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939244|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939245|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939246|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939247|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939248|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939249|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939250|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939251|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939252|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939253|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939254|NCT00982644|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939255|NCT00982644|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939256|NCT00982644|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939257|NCT00982644|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
939258|NCT00982592|B3|Baseline|Total|Total of all reporting groups
939259|NCT00982592|B2|Baseline|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939260|NCT00982592|B1|Baseline|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939261|NCT00982592|P2|Participant Flow|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939392|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939262|NCT00982592|P1|Participant Flow|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939263|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939264|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939265|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939266|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939267|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939268|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939269|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939270|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939271|NCT00982592|O2|Outcome|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939272|NCT00982592|O1|Outcome|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939273|NCT00982592|E2|Reported Event|Arm II (FOLFOX Regimen and Vismodegib)|Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939377|NCT00982228|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939274|NCT00982592|E1|Reported Event|Arm I (FOLFOX Regimen and Placebo)|Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
939275|NCT00982553|B1|Baseline|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
939276|NCT00982553|P1|Participant Flow|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
939277|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
939278|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
939279|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
939280|NCT00982553|O1|Outcome|Raltegravir and Ribavirin|Single dose ribavirin 800mg administered on day 1 followed by raltegravir 400 mg twice daily on day 15-19 then on day 20 single dose of both ribavirin and raltegravir administered together
939281|NCT00982553|E1|Reported Event|All Subjects|"All subjects received the same study therapy as follows:~Day 1 Ribavirin single dose 800 mg oral followed by intensive PK monitoring. Day 2 - 14 washout phase Day 15 - 18 raltegravir 400 mg twice daily followed by by intensive PK monitoring on day 18.~Day 19 raltegravir 400 mg plus ribavirin 800 mg by intensive PK monitoring."
939282|NCT00982488|B6|Baseline|Total|Total of all reporting groups
939283|NCT00982488|B5|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939496|NCT00982033|E1|Reported Event|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
939284|NCT00982488|B4|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939285|NCT00982488|B3|Baseline|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939286|NCT00982488|B2|Baseline|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939287|NCT00982488|B1|Baseline|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939288|NCT00982488|P5|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939289|NCT00982488|P4|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MPB|Participants with advanced phase disease, myeloid blast phase (MPB), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939378|NCT00982228|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939290|NCT00982488|P3|Participant Flow|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP) were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939291|NCT00982488|P2|Participant Flow|Imatinib, 400 mg BID, Chronic Phase|Participants chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939292|NCT00982488|P1|Participant Flow|Dasatinib 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939293|NCT00982488|O5|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939294|NCT00982488|O4|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939295|NCT00982488|O3|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID . Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939497|NCT00982020|B3|Baseline|Total|Total of all reporting groups
951305|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
939296|NCT00982488|O2|Outcome|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib twice daily (BID). Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939297|NCT00982488|O1|Outcome|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939298|NCT00982488|E5|Reported Event|Dasatinib, 50 mg QD to 120 mg, Advanced Phase, Ph+ ALL|Participants with advanced phase disease, Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939299|NCT00982488|E4|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, MBP|Participants with advanced phase disease, myeloid blast phase (MBP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939300|NCT00982488|E3|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Advanced Phase, AP|Participants with advanced phase disease, accelerated phase (AP), were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg QD to 120 mg BID. Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939301|NCT00982488|E2|Reported Event|Imatinib, 400 mg BID, Chronic Phase|Participants with chronic phase disease received 400 mg of imatinib BID. Dose reduction to 600 mg/day (300 mg BID) was permitted, provided the participant had not previously received that dose prior to entry into CA180-017. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939422|NCT00982189|E4|Reported Event|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
939302|NCT00982488|E1|Reported Event|Dasatinib, 50 mg QD to 120 mg BID, Chronic Phase|Participants with chronic phase disease were rolled over from previous studies CA180-039, CA180-043, and the SRC/ABL tyrosine kinase inhibition activity: Research trials (START). Participants continued on the previous study dose of dasatinib, ranging from 50 mg once daily (QD) to 120 mg twice daily (BID). Dose escalations to optimize response and dose reductions for toxicity were permitted. Participants received study medication until disease progression, unacceptable toxicity, failure to serve patient's best interest, withdrawal of consent, or study closure.
939303|NCT00982423|B3|Baseline|Total|Total of all reporting groups
939304|NCT00982423|B2|Baseline|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939305|NCT00982423|B1|Baseline|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
939306|NCT00982423|P2|Participant Flow|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939307|NCT00982423|P1|Participant Flow|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
939308|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939309|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
939310|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939311|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
939312|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939313|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
939314|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939315|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as GFR greater than or equal to 60 mg/min/1.73m^2.
939316|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939317|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
939318|NCT00982423|O2|Outcome|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939319|NCT00982423|O1|Outcome|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
939320|NCT00982423|E2|Reported Event|Compensated CHF With Renal Dysfunction|Renal Dysfunction was defined as GFR less than 60 mg/min/1.73m^2.
939321|NCT00982423|E1|Reported Event|Compensated CHF Without Renal Dysfunction|Preserved renal function was defined as glomerular filtration rate (GFR) greater than or equal to 60 mg/min/1.73m^2.
939322|NCT00982410|B3|Baseline|Total|Total of all reporting groups
939605|NCT00981461|E2|Reported Event|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
939323|NCT00982410|B2|Baseline|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939324|NCT00982410|B1|Baseline|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939325|NCT00982410|P2|Participant Flow|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939326|NCT00982410|P1|Participant Flow|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor Veterans Affairs Medical Center (VAMC). Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939327|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939379|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939380|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939328|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939329|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939330|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939331|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939332|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939333|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939334|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939393|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939606|NCT00981461|E1|Reported Event|Control Device|This control device is inactive emitting white light
939335|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939336|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939337|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939338|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939339|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
951435|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
939340|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939341|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939342|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group (CBT)|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939343|NCT00982410|O2|Outcome|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939344|NCT00982410|O1|Outcome|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939345|NCT00982410|E2|Reported Event|Educational Supportive Group|"A control condition providing social support and education about pain and/or drug use.~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The Educational Supportive Group condition’s provided psycho-education about topics such as substance abuse, chronic pain, and how to maintain a healthy lifestyle"
939346|NCT00982410|E1|Reported Event|Cognitive Behavioral Treatment Group|"An intervention treatment group to manage pain and decrease substance use abuse/misuse~Cognitive-behavioral treatment (CBT) interventions to manage pain and decrease substance use abuse/misuse~Each condition consisted of 10 weekly sessions, lasting approximately one hour in length, led by masters level therapists (i.e., social workers) at the Ann Arbor VAMC. Participants continued to receive their standard of care at the VA. The CBT condition’s main foci included cognitive skills, acceptance skills, behavioral skills, life skills and concepts, and relaxation exercises."
939347|NCT00982345|B1|Baseline|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
939348|NCT00982345|P1|Participant Flow|Seroquel XR|Seroquel XR (quetiapine) starting dose 50 mg and increased up to 400 mg as tolerated) treatment.
939349|NCT00982345|O1|Outcome|Quetiapine|quetiapine (Seroquel XR) : Seroquel XR (starting dose 100mg and increased up to 400 mg as tolerated) treatment.
939351|NCT00982280|B1|Baseline|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939352|NCT00982280|P1|Participant Flow|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939353|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939354|NCT00982280|O1|Outcome|Tapentadol|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939355|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939356|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939357|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939358|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939359|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939360|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939394|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939607|NCT00981435|B4|Baseline|Total|Total of all reporting groups
939361|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939362|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939363|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939364|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939365|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939366|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939367|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939368|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939369|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939370|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939395|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
951306|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
939371|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939372|NCT00982280|O1|Outcome|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939373|NCT00982280|E1|Reported Event|Tapentadol PR|All participants started with either 50 mg, 100 mg or 150 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride PR was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes however, participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
939374|NCT00982228|B3|Baseline|Total|Total of all reporting groups
939375|NCT00982228|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939376|NCT00982228|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939381|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939382|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939383|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939384|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939385|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939386|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939387|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939388|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939389|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939390|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939391|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939437|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
939396|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939397|NCT00982228|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939398|NCT00982228|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939399|NCT00982228|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
939400|NCT00982228|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
939401|NCT00982189|B5|Baseline|Total|Total of all reporting groups
939402|NCT00982189|B4|Baseline|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
939403|NCT00982189|B3|Baseline|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
939404|NCT00982189|B2|Baseline|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
939405|NCT00982189|B1|Baseline|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
939406|NCT00982189|P4|Participant Flow|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
939407|NCT00982189|P3|Participant Flow|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
939408|NCT00982189|P2|Participant Flow|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
939409|NCT00982189|P1|Participant Flow|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
939410|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
939411|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
939412|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
939413|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
939414|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
939415|NCT00982189|O3|Outcome|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
939416|NCT00982189|O2|Outcome|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
939417|NCT00982189|O1|Outcome|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
939418|NCT00982189|O4|Outcome|L-placebo/P-placebo|Placebo pill (matched to pravastatin) and placebo pill (matched to lisinopril) once daily
939423|NCT00982189|E3|Reported Event|Lisinopril/Pravastatin|Lisinopril 10mg and Pravastatin 20mg once daily
939424|NCT00982189|E2|Reported Event|L-placebo/Pravastatin|Placebo pill (matched to lisinopril) and Pravastatin 20mg once daily
939425|NCT00982189|E1|Reported Event|Lisinopril/P-placebo|Lisinopril 10mg and placebo (matched to pravastatin) once daily
939426|NCT00982137|B5|Baseline|Total|Total of all reporting groups
939427|NCT00982137|B4|Baseline|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
939428|NCT00982137|B3|Baseline|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
939429|NCT00982137|B2|Baseline|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
939430|NCT00982137|B1|Baseline|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
939431|NCT00982137|P4|Participant Flow|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
939432|NCT00982137|P3|Participant Flow|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
939433|NCT00982137|P2|Participant Flow|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
939434|NCT00982137|P1|Participant Flow|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
939435|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
939436|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
951307|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
939439|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
939440|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
939441|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-JE on Day 30.
939442|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
939443|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
939444|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
939445|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
939446|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
939447|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
939448|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
939449|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
939450|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
939451|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|Subjects received STAMARIL® then ChimeriVaxTM-JE vaccination with diluent (both left and right arms) on Day 0, then STAMARIL® then ChimeriVaxTM-JE vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
939452|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
939453|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
939454|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
939455|NCT00982137|O4|Outcome|Diluent Then Coadministration With ChimeriVax™-JE and STAMARIL|Subjects received sc vaccination with diluent (both left and right arms) on Day 0, then sc vaccination with ChimeriVax™-JE (right arm) and STAMARIL® (left arm) on Day 30.
939456|NCT00982137|O3|Outcome|Co-administration of ChimeriVax™-JE and STAMARIL, Then Diluent|Participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in both left and right arms on Day 30.
939457|NCT00982137|O2|Outcome|STAMARIL® Then ChimeriVax™-JE|Participants received a single dose of STAMARIL® on Day 0 and a single dose of ChimeriVax™-J on Day 30.
939458|NCT00982137|O1|Outcome|ChimeriVax™-JE Then STAMARIL®|Participants received a single ChimeriVax™-JE on Day 0 and a single dose of STAMARIL® on Day 30.
939459|NCT00982137|E4|Reported Event|Diluent Then Coadministration With ChimeriVax-JE and STAMARIL®|All participants received diluent vaccination (left and right arms)on Day 0, followed with STAMARIL® (left arm) and ChimeriVax™-JE (right arm) on Day 30.
939460|NCT00982137|E3|Reported Event|Co-administration of ChimeriVax™-JE and STAMARIL® Then Diluent|All participants received 1 dose each of ChimeriVax™-JE (left arm) and STAMARIL® (right arm) on Day 0 and diluent in the left and right arms on Day 30.
939461|NCT00982137|E2|Reported Event|STAMARIL® Then ChimeriVax™-JE|All participants received a single dose of STAMARIL® vaccine on Day 0 and a single dose of ChimeriVax™-JE vaccine on Day 30.
939462|NCT00982137|E1|Reported Event|ChimeriVax™-JE Then STAMARIL®|All participants received a single ChimeriVax™-JE vaccine on Day 0 and a single dose of STAMARIL® vaccine on Day 30.
939463|NCT00982111|B3|Baseline|Total|Total of all reporting groups
939464|NCT00982111|B2|Baseline|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939465|NCT00982111|B1|Baseline|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939466|NCT00982111|P2|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
939467|NCT00982111|P1|Participant Flow|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 milligrams (mg) (absolute dose) on Days 1 and 8 of every 3-week cycle.~Pemetrexed: 500 mg/square meter (mg/m2) intravenous (I.V.) on Day 1 of every 3-week cycle, for a maximum of six cycles.~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles."
939468|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939563|NCT00981630|B3|Baseline|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
940883|NCT00977665|E1|Reported Event|Placebo|Placebo tablet for up to 48 weeks.
939469|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939470|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939471|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939472|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939473|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939474|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939475|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939476|NCT00982111|O1|Outcome|Necitumumab + Pemextrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939477|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939478|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939479|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939480|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939481|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939539|NCT00981825|B1|Baseline|Fluoride 1st, Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)
939482|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939483|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939484|NCT00982111|O2|Outcome|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939485|NCT00982111|O1|Outcome|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle, administered as an I.V. infusion~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939486|NCT00982111|E2|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed + Cisplatin~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939487|NCT00982111|E1|Reported Event|Necitumumab + Pemetrexed + Cisplatin|"Necitumumab + Pemetrexed + Cisplatin~Necitumumab: 800 mg (absolute dose) on Days 1 and 8 of every 3-week cycle~Pemetrexed: 500 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles~Cisplatin: 75 mg/m2 I.V. on Day 1 of every 3-week cycle, for a maximum of six cycles"
939488|NCT00982033|B3|Baseline|Total|Total of all reporting groups
939489|NCT00982033|B2|Baseline|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
939490|NCT00982033|B1|Baseline|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
939491|NCT00982033|P2|Participant Flow|Placebo|"50% of subjects will be randomized to placebo.~placebo: placebo qd for 24 weeks"
939492|NCT00982033|P1|Participant Flow|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd, the other 50% will be on placebo.~aliskiren: aliskiren 300mg qd versus placebo for 24 weeks."
939493|NCT00982033|O2|Outcome|Placebo|"50% of subjects participating in this trial will be randomized to placebo.~placebo: placebo qd for 24 weeks."
939494|NCT00982033|O1|Outcome|Aliskiren|"50 % of subjects participating in this trial will be on the active medication, Aliskiren 300mg qd.~aliskiren: aliskiren 300mg qd for 24 weeks."
939498|NCT00982020|B2|Baseline|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
939499|NCT00982020|B1|Baseline|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
939500|NCT00982020|P2|Participant Flow|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
939501|NCT00982020|P1|Participant Flow|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 milligrams (mg) to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
939502|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
939503|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
939504|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
939505|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
939506|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
939507|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
939508|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
939509|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
939510|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
939511|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
939512|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits"
939513|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks.~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
939514|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
939515|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
939516|NCT00982020|O2|Outcome|Olanzapine/Intense Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits
939517|NCT00982020|O1|Outcome|Olanzapine/Standard Behavioral Weight Intervention|Olanzapine: 2.5 mg to 20 mg given orally, daily for 52 weeks. Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only
939604|NCT00981461|O1|Outcome|Control Device|This control device is inactive emitting white light
951308|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
939518|NCT00982020|E2|Reported Event|Olanzapine/Intense Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Intense behavioral weight intervention: Counseling provided at randomization and at all subsequent study visits by appropriately trained individual regarding healthy lifestyle habits. Participants also provided with simple tools to help enable healthy eating and exercise habits."
939519|NCT00982020|E1|Reported Event|Olanzapine/Standard Behavioral Weight Intervention|"Olanzapine: 2.5mg to 20mg given orally, daily for 52 weeks~Standard behavioral weight intervention: One time counseling and basic counseling information on healthy eating and exercise habits at randomization visit only"
939520|NCT00982007|B5|Baseline|Total|Total of all reporting groups
939521|NCT00982007|B4|Baseline|Cohort 2 (Group D) - IV Iron (Standard of Care)|Other IV iron IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion
939522|NCT00982007|B3|Baseline|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939523|NCT00982007|B2|Baseline|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
939524|NCT00982007|B1|Baseline|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939525|NCT00982007|P4|Participant Flow|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
939526|NCT00982007|P3|Participant Flow|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939527|NCT00982007|P2|Participant Flow|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
939528|NCT00982007|P1|Participant Flow|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939529|NCT00982007|O4|Outcome|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
939530|NCT00982007|O3|Outcome|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939531|NCT00982007|O2|Outcome|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
939532|NCT00982007|O1|Outcome|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939533|NCT00982007|E4|Reported Event|Cohort 2 (Group D) - IV Iron (Standard of Care)|"Other IV iron~IV Iron (standard of care) : IV standard of care (other IV iron) per the Investigator's discretion"
939534|NCT00982007|E3|Reported Event|Cohort 2 (Group C) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939535|NCT00982007|E2|Reported Event|Cohort 1 (Group B) - Ferrous Sulfate|"Oral iron~Ferrous Sulfate Tablets : 325 mg Ferrous Sulfate tablets taken orally three times a day"
939536|NCT00982007|E1|Reported Event|Cohort 1 (Group A) - Ferric Carboxymaltose (FCM)|"Intravenous (IV) iron~Ferric Carboxymaltose (FCM) : A total maximum cumulative dose of 1500 mg administered on Days 0 and 7."
939537|NCT00981825|B3|Baseline|Total|Total of all reporting groups
939538|NCT00981825|B2|Baseline|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)
939540|NCT00981825|P2|Participant Flow|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
939541|NCT00981825|P1|Participant Flow|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
939542|NCT00981825|O2|Outcome|Triclosan/Fluoride Toothpaste|Triclosan/Fluoride toothpaste (experimental)
939543|NCT00981825|O1|Outcome|Fluoride Toothpaste (Control)|Fluoride toothpaste (control)
939544|NCT00981825|E2|Reported Event|Triclosan/Fluoride 1st, Fluoride 2nd|Triclosan/Fluoride toothpaste (experimental)used in first period,washout of 7 days, then Fluoride in second period.
939545|NCT00981825|E1|Reported Event|Fluoride 1st , Triclosan/Fluoride 2nd|Fluoride toothpaste (placebo)used in first period, then washout of 7 days, then Triclosan/Fluoride in second period.
939546|NCT00981812|B1|Baseline|Primary|Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy.
939547|NCT00981812|P1|Participant Flow|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
939548|NCT00981812|O1|Outcome|Lesions Visualized Using Positron Emission Mammography (PEM)|Total lesions visualized using positron emission mammography.
939549|NCT00981812|E1|Reported Event|PEM Breast Biopsy|PEM Breast Biopsy: Breast biopsy using PEM guidance and Stereo Navigator software
939550|NCT00981669|B3|Baseline|Total|Total of all reporting groups
939551|NCT00981669|B2|Baseline|Placebo|3 doses with 6 weeks interval
939552|NCT00981669|B1|Baseline|Rotavirus Vaccine|3 doses with 6 weeks interval
939553|NCT00981669|P2|Participant Flow|Placebo|3 doses with 6 weeks interval
939554|NCT00981669|P1|Participant Flow|Rotavirus Vaccine|3 doses with 6 weeks interval
939555|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
939556|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
939557|NCT00981669|O2|Outcome|Placebo|3 doses with 6 weeks interval
939558|NCT00981669|O1|Outcome|Rotavirus Vaccine|3 doses with 6 weeks interval
939559|NCT00981669|E2|Reported Event|Placebo|3 doses with 6 weeks interval
939560|NCT00981669|E1|Reported Event|Rotavirus Vaccine|3 doses with 6 weeks interval
939561|NCT00981630|B5|Baseline|Total|Total of all reporting groups
939562|NCT00981630|B4|Baseline|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939564|NCT00981630|B2|Baseline|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939565|NCT00981630|B1|Baseline|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939566|NCT00981630|P4|Participant Flow|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939567|NCT00981630|P3|Participant Flow|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939568|NCT00981630|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939569|NCT00981630|P1|Participant Flow|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939570|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939571|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939572|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939573|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939574|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939575|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939576|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939577|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939578|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939579|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939580|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939581|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939582|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939583|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939584|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939585|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939586|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939587|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939588|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939682|NCT00981292|E5|Reported Event|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
939589|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939590|NCT00981630|O4|Outcome|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939591|NCT00981630|O3|Outcome|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939592|NCT00981630|O2|Outcome|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939593|NCT00981630|O1|Outcome|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939594|NCT00981630|E4|Reported Event|Placebo|All participants received a single dose of Placebo (diluent) on Day 0.
939595|NCT00981630|E3|Reported Event|ChimeriVax™-JE 5 log10 PFU|All participants received a single dose of ChimeriVax™-JE 5 log10 Plaque-forming units (PFU) vaccine on Day 0
939596|NCT00981630|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU|All participants received a single dose of ChimeriVax™-JE 4 log10 Plaque-forming units (PFU) vaccine on Day 0.
939597|NCT00981630|E1|Reported Event|ChimeriVax™-JE 3 log10 PFU|All participants received a single dose of ChimeriVax™-JE 3 log10 Plaque-forming units (PFU) vaccine on Day 0.
939598|NCT00981461|B3|Baseline|Total|Total of all reporting groups
939599|NCT00981461|B2|Baseline|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full length of study. This arm of the study was blinded and dispensed to subjects on a random basis.
939600|NCT00981461|B1|Baseline|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full length of study. This device was distributed to subjects in a blinded randomized manner
939601|NCT00981461|P2|Participant Flow|Control Device|This arm involves the use of an inactive control device that emits white light. The device is used 3 times a week for full 26 duration of study. This arm of the study was blinded and dispensed to subjects on a random basis.Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
939602|NCT00981461|P1|Participant Flow|HairMax LaserComb 2009 9 Beam|This arm involves the active LLLT device with 9 laser modules. The device is used 3 times a week for 12 minutes per session for full 26 duration of the study. This device was distributed to subjects in a blinded randomized manner. Subjects were evaluated at 8, 16 and 26 weeks, with hair counts performed at week 16 and 26.
939603|NCT00981461|O2|Outcome|HairMax LaserComb 2009 9 Beam|This device is the active device with 9 laser modules
939608|NCT00981435|B3|Baseline|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
939609|NCT00981435|B2|Baseline|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
939610|NCT00981435|B1|Baseline|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
939611|NCT00981435|P3|Participant Flow|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
939612|NCT00981435|P2|Participant Flow|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
939613|NCT00981435|P1|Participant Flow|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
939614|NCT00981435|O3|Outcome|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
939615|NCT00981435|O2|Outcome|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
939616|NCT00981435|O1|Outcome|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
939617|NCT00981435|O3|Outcome|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
939618|NCT00981435|O2|Outcome|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
939619|NCT00981435|O1|Outcome|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
939620|NCT00981435|E3|Reported Event|Steroid|Prednisolone 1%: Prednisolone 1% to lasered eye 4 times/day for 4.5 days
939621|NCT00981435|E2|Reported Event|Non-steroidal Anti-inflammatory|Diclofenac 0.1%: Diclofenac sodium 0.1% to lasered eye 4 times/day for 4.5 days
939622|NCT00981435|E1|Reported Event|Artificial Tears|Artificial Tears: Artificial saline tears to lasered eye 4 times/day for 4.5 days
939623|NCT00981409|B3|Baseline|Total|Total of all reporting groups
939624|NCT00981409|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939625|NCT00981409|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
939626|NCT00981409|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939627|NCT00981409|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
940136|NCT00980148|P2|Participant Flow|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
939628|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939629|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
939630|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939631|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
939632|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939633|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
939711|NCT00981227|E5|Reported Event|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
939712|NCT00981227|E4|Reported Event|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
939634|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939635|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
939636|NCT00981409|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939637|NCT00981409|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
939638|NCT00981409|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (aPTT) at 1.5 to 2.5 times control and administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
939639|NCT00981409|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
939640|NCT00981370|B1|Baseline|Group 1|First group of subjects to be enrolled.
939641|NCT00981370|P1|Participant Flow|Group One|No enrollment
939642|NCT00981370|O1|Outcome|Group 1|First group of subjects enrolled.
939643|NCT00981370|E1|Reported Event|Group 1|No patients enrolled
939644|NCT00981305|B3|Baseline|Total|Total of all reporting groups
939645|NCT00981305|B2|Baseline|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939646|NCT00981305|B1|Baseline|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939683|NCT00981292|E4|Reported Event|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
951436|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
939647|NCT00981305|P2|Participant Flow|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939648|NCT00981305|P1|Participant Flow|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939649|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939650|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939651|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939652|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939653|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939654|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939655|NCT00981305|O2|Outcome|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939713|NCT00981227|E3|Reported Event|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
939714|NCT00981227|E2|Reported Event|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
939656|NCT00981305|O1|Outcome|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939657|NCT00981305|E2|Reported Event|Placebo|"apply 3cc of placebo vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Placebo vaginal lubricant: vaginal applying at least 3cc of placebo lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939658|NCT00981305|E1|Reported Event|Lactate-containing Vaginal Lubricant|"apply 3cc of lactate-containing vaginal lubricant before sexual intercourse or sleeping for 8wks (at least 3 times per week)~Lactate-containing vaginal lubricant: vaginal applying at least 3cc of lactate-containing lubricant at the time of sexual intercourse or before sleeping for 8 weeks (at least 3 times/week)"
939659|NCT00981292|B7|Baseline|Total|Total of all reporting groups
939660|NCT00981292|B6|Baseline|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
939661|NCT00981292|B5|Baseline|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
939662|NCT00981292|B4|Baseline|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
939663|NCT00981292|B3|Baseline|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
939664|NCT00981292|B2|Baseline|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
939665|NCT00981292|B1|Baseline|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
939666|NCT00981292|P6|Participant Flow|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
939667|NCT00981292|P5|Participant Flow|0mg EGCG Then 270mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
939668|NCT00981292|P4|Participant Flow|135mg EGCG Then 270mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
939669|NCT00981292|P3|Participant Flow|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
939670|NCT00981292|P2|Participant Flow|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
939671|NCT00981292|P1|Participant Flow|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
939672|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
939673|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
939674|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
939675|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
939676|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
939677|NCT00981292|O1|Outcome|135mg|All participants when consumed 135mg EGCG.
939678|NCT00981292|O3|Outcome|Placebo|All participants when consumed Placebo.
939679|NCT00981292|O2|Outcome|270mg EGCG|All participants when consumed 270mg EGCG.
939680|NCT00981292|O1|Outcome|135mg EGCG|All participants when consumed 135mg EGCG.
939681|NCT00981292|E6|Reported Event|270mg EGCG Then 0mg EGCG Then 135mg EGCG|Those participants who received treatment in this order.
939684|NCT00981292|E3|Reported Event|0mg EGCG Then 135mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
939685|NCT00981292|E2|Reported Event|270mg EGCG Then 135mg EGCG Then 0mg EGCG|Those participants who received treatment in this order.
939686|NCT00981292|E1|Reported Event|135mg EGCG Then 0mg EGCG Then 270mg EGCG|Those participants who received treatment in this order.
939687|NCT00981227|B7|Baseline|Total|Total of all reporting groups
939688|NCT00981227|B6|Baseline|Placebo|"placebo~Placebo : oral route"
939689|NCT00981227|B5|Baseline|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
939690|NCT00981227|B4|Baseline|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
939691|NCT00981227|B3|Baseline|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
939692|NCT00981227|B2|Baseline|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
939693|NCT00981227|B1|Baseline|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
939694|NCT00981227|P6|Participant Flow|Placebo|"placebo~Placebo : oral route"
939695|NCT00981227|P5|Participant Flow|ESL 800 mg Twice Daily|"ESL 800 mg twice daily~Eslicarbazepine acetate : Scored tablets"
939696|NCT00981227|P4|Participant Flow|ESL 800 mg Once-daily|"ESL 800 mg once-daily~Eslicarbazepine acetate : Scored tablets"
939697|NCT00981227|P3|Participant Flow|ESL 600 mg Twice Daily|"ESL 600 mg twice daily~Eslicarbazepine acetate : Scored tablets"
939698|NCT00981227|P2|Participant Flow|ESL 400 mg Twice-daily|"ESL 400 mg twice-daily~Eslicarbazepine acetate : Scored tablets"
939699|NCT00981227|P1|Participant Flow|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
939700|NCT00981227|O4|Outcome|ESL 800 mg/Day|total daily dose;oral route
939701|NCT00981227|O3|Outcome|ESL 1600 mg/Day|total daily dose;oral route
939702|NCT00981227|O2|Outcome|ESL 1200 mg/Day|total daily dose;oral route
939703|NCT00981227|O1|Outcome|Placebo|"placebo~Placebo : oral route"
939704|NCT00981227|O6|Outcome|Placebo|total daily dose;oral route
939705|NCT00981227|O5|Outcome|ESL 800 mg Twice Daily|total daily dose;oral route
939706|NCT00981227|O4|Outcome|ESL 800 mg Once-daily|total daily dose;oral route
939707|NCT00981227|O3|Outcome|ESL 600 mg Twice Daily|total daily dose;oral route
939708|NCT00981227|O2|Outcome|ESL 400 mg Twice-daily|total daily dose;oral route
939709|NCT00981227|O1|Outcome|ESL 1200 mg Once Daily|total daily dose;oral route
939710|NCT00981227|E6|Reported Event|Placebo|"placebo~Placebo : oral route"
939715|NCT00981227|E1|Reported Event|ESL 1200 mg Once Daily|"ESL 1200 mg once daily~Eslicarbazepine acetate : Scored tablets"
939716|NCT00981214|B1|Baseline|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939717|NCT00981214|P1|Participant Flow|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939718|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939719|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939720|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939721|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939722|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939723|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939757|NCT00981084|B3|Baseline|Total|Total of all reporting groups
939758|NCT00981084|B2|Baseline|Placebo Then Armodafinil|
939941|NCT00980642|P1|Participant Flow|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
939724|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939725|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939726|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939727|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939728|NCT00981214|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in a capsule was administered orally from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or the content of the capsule was allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939729|NCT00981214|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) Microtabs contained in capsule was administered orally or sprinkled on food. When required, from Day 5 to Day 11 at an enzyme dose based on investigator's discretion, in dose stabilization period or allowed to sprinkle on food, where necessary, followed by stabilized dose from Day 12 to Day 18 in treatment period, up to a maximum total dose of 10,000 lipase units per kilogram body weight per day (unit/kg/day).
939730|NCT00981175|B4|Baseline|Total|Total of all reporting groups
939731|NCT00981175|B3|Baseline|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
939732|NCT00981175|B2|Baseline|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
939733|NCT00981175|B1|Baseline|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
939734|NCT00981175|P2|Participant Flow|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on day 28.
939735|NCT00981175|P1|Participant Flow|ChimeriVax™-JE Vaccine First, Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on day 28.
939736|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at month 6 following primary ChimeriVax™-JE and Diluent vaccination at Day 0 and Day 28
939737|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent) at either Day 0 or Day 28
939738|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
939739|NCT00981175|O3|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
939740|NCT00981175|O2|Outcome|Placebo Vaccine|Participants received a dose of placebo vaccine (diluent)at either Day 0 or Day 28
939741|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine|Participants received a primary dose of ChimeriVax™-JE vaccine at either Day 0 or Day 28
939742|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
939743|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
939744|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
939745|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
939746|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
939747|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
939748|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
939749|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
939750|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
939751|NCT00981175|O3|Outcome|No Booster Vaccine|Participants did not receive a booster dose Chimerivax™-JE vaccine
939752|NCT00981175|O2|Outcome|Booster ChimeriVax™-JE Vaccine|Participants received ChimeriVax™-JE vaccine booster at month 6.
939753|NCT00981175|O1|Outcome|ChimeriVax™-JE Vaccine (Single or Primary)|Outcome for all participants that received ChimeriVax™-JE vaccine on Day 0 or day 28.
939754|NCT00981175|E3|Reported Event|Booster ChimeriVax™-JE Vaccine|Participants received a booster dose of ChimeriVax™-JE vaccine at Month 6 Following vaccination with ChimeriVax™-JE vaccine and Diluent (Placebo) at Day 0 and Day 28
939755|NCT00981175|E2|Reported Event|Placebo First, Then ChimeriVax™-JE Vaccine|Participants received vaccine diluent (placebo) on Day 0 and ChimeriVax™-JE vaccine on Day 28.
939756|NCT00981175|E1|Reported Event|ChimeriVax™-JE Vaccine First , Then Placebo|Participants received ChimeriVax™-JE vaccine on Day 0 and vaccine diluent (placebo) on Day 28.
939759|NCT00981084|B1|Baseline|Armodafinil Then Placebo|"All participants will receive one dose of armodafinil and one dose of placebo in a cross-over design~armodafinil : Half of the patients will be randomized to receive a single oral dose of placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions."
939760|NCT00981084|P2|Participant Flow|Placebo First and Armodafinil Second|Patients randomly assigned to this condition received a placebo in the first treatment period. There was then a one week washout period. They then received 250 mg armodafinil in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
939761|NCT00981084|P1|Participant Flow|Armodafinil First and Placebo Second|Patients randomly assigned to this condition received a 250 mg dose of armodafinil in the first treatment period. There was then a one week washout period. They received a placebo in the second treatment period. Testing was conducted 2 hours after treatment adminsitration using counterbalanced alternate forms.
939762|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
939763|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
939764|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
939765|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
939766|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
939767|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
939768|NCT00981084|O2|Outcome|Armodafinil/Placebo|armodafinil first and then placebo. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
941157|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
939769|NCT00981084|O1|Outcome|Placebo/Armofafinil|placebo first then armodafinil. Participants were tested after each intervention with alternate forms of outcome measures. Outcome scores from session 2 were subtracted from session 1 scores.
939770|NCT00981084|E4|Reported Event|Armodafinil Then Placebo (Placebo)|number of adverse events following placebo in the armodafniil then placebo condition.
939771|NCT00981084|E3|Reported Event|Placebo Then Armodafinil (Armodafinil)|Adverse events following armodafinil in the placebo/armodafinil group
939772|NCT00981084|E2|Reported Event|Armodafinil Then Placebo (Armodafinil)|Adverse events reported after taking armodafinil in the Armodafinil then placebo group
939773|NCT00981084|E1|Reported Event|Placebo Then Armodafinil (Placebo)|Adverse events reported after taking placebo in the Placebo then Armodafinil Group
939774|NCT00981058|B3|Baseline|Total|Total of all reporting groups
939775|NCT00981058|B2|Baseline|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939776|NCT00981058|B1|Baseline|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939777|NCT00981058|P2|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939778|NCT00981058|P1|Participant Flow|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 milligrams (mg) I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 milligrams/square meter (mg/m2) on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939779|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939780|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939781|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939807|NCT00981045|E1|Reported Event|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
939942|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
939782|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939783|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939784|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939785|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939786|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939787|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939788|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939789|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939790|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939791|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939833|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939792|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939793|NCT00981058|O2|Outcome|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939794|NCT00981058|O1|Outcome|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939795|NCT00981058|E2|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine + Cisplatin~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939796|NCT00981058|E1|Reported Event|Necitumumab + Gemcitabine + Cisplatin|"Necitumumab + Gemcitabine + Cisplatin~Necitumumab: 800 mg I.V. infusion on Days 1 and 8 of every 3 week cycle.~Continues until progressive disease, toxicity, noncompliance, or withdrawal.~Gemcitabine: 1250 mg/m2 on Days 1 and 8 of every 3 week cycle.~Continues for a maximum of six cycles.~Cisplatin: 75 mg/m2 IV on Day 1 of every 3 week cycle.~Continues for a maximum of six cycles."
939797|NCT00981045|B3|Baseline|Total|Total of all reporting groups
939798|NCT00981045|B2|Baseline|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
939799|NCT00981045|B1|Baseline|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
939800|NCT00981045|P2|Participant Flow|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
939801|NCT00981045|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
939802|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
939803|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
939804|NCT00981045|O2|Outcome|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
939805|NCT00981045|O1|Outcome|Ferric Carboxymaltose (FCM)|Ferric Carboxymaltose (FCM) : 2 doses at 15 mg/kg to a maximum 750 mg per dose for a total maximum cumulative dose of 1500 mg
939806|NCT00981045|E2|Reported Event|Iron Sucrose (Venofer)|Iron Sucrose (Venofer) : 5 doses of 200 mg for a total cumulative dose of 1000 mg
940137|NCT00980148|P1|Participant Flow|Azithromycin Arm|Azithromycin 1 gm oral single dose
939808|NCT00981019|B1|Baseline|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
939809|NCT00981019|P1|Participant Flow|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
939810|NCT00981019|O1|Outcome|Mortality*Incidence*5-year Survival*Early Detection Rate|The survey introduced four different cancer statistics in scenarios about 2 different screening tests. To mask the fact that all statistics stemmed from prostate cancer screening, screening in the scenarios were labeled “X” and “Z”. The survey then introduced test Z, whose effectiveness was described in terms of a reduction of cancer mortality. After responding to the series of outcome questions about test Z, physicians received additional information on the cancer incidence, again followed by the outcome questions. In the next scenario, the survey introduced test X, whose effectiveness was described in terms of an increase in 5-year survival and, in the next step, with additional information on early detection rates. After each step, doctors had to respond to the same outcome questions as they had for test Z. Please not, information on test X and test Z were randomly presented to control for order effects.
939811|NCT00981019|E1|Reported Event|Mortality*Incidence*5-year Survival*Early Detection Rate|The study—conducted as an online survey study—investigated the influence that different medical statistics such as 5-year survival rates would have on physicians' recommendation behavior for screening and on their judgment of screening's effectiveness. The survey introduced hypothetical scenarios in which a hypothetical patient was requesting a physician's advice on whether to have a screening test. To make that decision the participants (=physicians) were presented with different statistics and then asked if they would recommend the screening to the hypothetical patient and how effective they think the screening would be in reducing cancer mortality. The online survey did not ask any sensitive data.
939812|NCT00980980|B4|Baseline|Total|Total of all reporting groups
939869|NCT00980746|P1|Participant Flow|ESL 1200 mg QD|Eslicarbazepine acetate (ESL) 1200 mg once daily. ESL tablets, scored to allow dose titration during the titration period.
939870|NCT00980746|O6|Outcome|Placebo|"Placebo~Placebo : oral route"
941158|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
939813|NCT00980980|B3|Baseline|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939814|NCT00980980|B2|Baseline|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939815|NCT00980980|B1|Baseline|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939816|NCT00980980|P3|Participant Flow|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939817|NCT00980980|P2|Participant Flow|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939818|NCT00980980|P1|Participant Flow|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939819|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939820|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939821|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939822|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939823|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939824|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939825|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939826|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939827|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939828|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939829|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939830|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939831|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Continuation of Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939832|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US - a combination of daily baths with 2% chlorhexidine cloths , plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939834|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939835|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939836|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939837|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance, Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939838|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939839|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939840|NCT00980980|O3|Outcome|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939841|NCT00980980|O2|Outcome|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939842|NCT00980980|O1|Outcome|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs, Contact Precautions for MRSA+
939843|NCT00980980|E3|Reported Event|Arm 3: Universal Decolonization|"Chlorhexidine bath and nasal mupirocin for all, Discontinuation of Active Surveillance , Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
940138|NCT00980148|O2|Outcome|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
939844|NCT00980980|E2|Reported Event|Arm 2: Targeted Decolonization|"Continue Active Surveillance (AS), MRSA decolonization based on AS, Continue Contact Precautions for MRSA+~Chlorhexidine bath and nasal mupirocin: The intervention / decolonization regimen will consist of the most commonly used topical regimen in the US – a combination of daily baths with 2% chlorhexidine cloths, plus 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily)"
939845|NCT00980980|E1|Reported Event|Arm 1: Usual Care-Active Surveillance|Active Surveillance in All Adult ICUs Contact Precautions for MRSA+
939846|NCT00980798|B3|Baseline|Total|Total of all reporting groups
939847|NCT00980798|B2|Baseline|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
939848|NCT00980798|B1|Baseline|Placebo|Placebo daily for 16 weeks
939849|NCT00980798|P2|Participant Flow|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
939850|NCT00980798|P1|Participant Flow|Placebo|Placebo daily for 16 weeks
939851|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
939852|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
939853|NCT00980798|O2|Outcome|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
939854|NCT00980798|O1|Outcome|Placebo|Placebo daily for 16 weeks
939855|NCT00980798|E2|Reported Event|OROS Hydromorphone HCl|4 to 32 mg taken orally once daily for 16 weeks
939856|NCT00980798|E1|Reported Event|Placebo|Placebo daily for 16 weeks
939857|NCT00980746|B7|Baseline|Total|Total of all reporting groups
939858|NCT00980746|B6|Baseline|Placebo|"Placebo~Placebo : oral route"
939859|NCT00980746|B5|Baseline|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939860|NCT00980746|B4|Baseline|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939861|NCT00980746|B3|Baseline|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939862|NCT00980746|B2|Baseline|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939863|NCT00980746|B1|Baseline|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939864|NCT00980746|P6|Participant Flow|Placebo|"Placebo~Placebo : oral route"
939865|NCT00980746|P5|Participant Flow|ESL 800 mg QD|"ESL 800 mg once-daily~ESL tablets, scored to allow dose titration during the titration period."
939866|NCT00980746|P4|Participant Flow|ESL 800 mg BID|"ESL 800 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
939867|NCT00980746|P3|Participant Flow|ESL 600 mg BID|"ESL 600 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
939868|NCT00980746|P2|Participant Flow|ESL 400 mg BD|"ESL 400 mg twice daily~ESL tablets, scored to allow dose titration during the titration period."
939871|NCT00980746|O5|Outcome|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939872|NCT00980746|O4|Outcome|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939873|NCT00980746|O3|Outcome|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939874|NCT00980746|O2|Outcome|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939875|NCT00980746|O1|Outcome|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939876|NCT00980746|E6|Reported Event|Placebo|"Placebo~Placebo : oral route"
939877|NCT00980746|E5|Reported Event|ESL 800 mg QD|"ESL 800 mg once-daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939878|NCT00980746|E4|Reported Event|ESL 800 mg BID|"Eslicarbazepine acetate 800 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939879|NCT00980746|E3|Reported Event|ESL 600 mg BID|"Eslicarbazepine 600 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939880|NCT00980746|E2|Reported Event|ESL 400 mg BD|"ESL 400 mg twice daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939881|NCT00980746|E1|Reported Event|ESL 1200 mg QD|"Eslicarbazepine acetate 1200 mg once daily~Eslicarbazepine acetate : Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period."
939882|NCT00980681|B1|Baseline|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
939883|NCT00980681|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-OF-Flight (TOF) Magnetic Resonance Angiography (MRA) followed by a Dotarem-enhanced MRA (with one injection of Dotarem 0.2ml/kg).
939884|NCT00980681|O2|Outcome|Time-Of-Flight MRA|Patients benefiting from an MRA with no injection of contrast medium
939885|NCT00980681|O1|Outcome|Dotarem-enhanced MRA|Patients benefiting from an MRA after administration with Dotarem
939886|NCT00980681|E2|Reported Event|Time Of Flight|"Each subject will undergo a TOF Magnetic Resonance Angiography~Time of Flight: Each subject will undergo a TOF MRA"
939887|NCT00980681|E1|Reported Event|Dotarem|"Each subject will receive one injection of Dotarem 0.2ml/kg.~Dotarem: Each subject will receive one injection of Dotarem 0.2ml/kg"
939888|NCT00980655|B3|Baseline|Total|Total of all reporting groups
939943|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
939889|NCT00980655|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939890|NCT00980655|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939891|NCT00980655|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939892|NCT00980655|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939893|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939894|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939895|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939896|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939967|NCT00980330|B6|Baseline|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940214|NCT00979953|P2|Participant Flow|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
939897|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939898|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939899|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939900|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939901|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939902|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939903|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939936|NCT00980655|E1|Reported Event|13vPnC Dose 1 to 13vPnC Dose 3 Blood Draw|All participants aged 2 years and above who received 3 single 0.5 mL doses of 13vPnC intramuscular injections at 1-month intervals, were assessed from 13vPnC Dose 1 to the blood draw 1 month after 13vPnC Dose 3.
939937|NCT00980642|B3|Baseline|Total|Total of all reporting groups
939904|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939905|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939906|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939907|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939908|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939909|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939910|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939911|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939912|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939929|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939913|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939914|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939915|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939916|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939917|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939918|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939938|NCT00980642|B2|Baseline|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
939939|NCT00980642|B1|Baseline|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
939919|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939920|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939921|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939922|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939923|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939924|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939925|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939926|NCT00980655|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Adult participants aged 18 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939927|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939928|NCT00980655|O3|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939966|NCT00980330|B7|Baseline|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
941159|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
939930|NCT00980655|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Pediatric participants aged 2 to 17 years received 4 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injections followed by single 0.5 mL dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939931|NCT00980655|O1|Outcome|13vPnC, 23vPS (All Participants)|All participants aged 2 years and above received 4 single 0.5 mL doses of 13vPnC intramuscular injections followed by single 0.5 mL dose of 23vPS intramuscular injection. 13vPnC Doses 1 to 3 were administered at 1-month intervals, 13vPnC Dose 4 was administered at 6 months after 13vPnC Dose 3, and 23vPS was administered 1 month after 13vPnC Dose 4.
939932|NCT00980655|E5|Reported Event|Follow-up|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from blood draw 1 month after 23vPS Dose to 6-month follow-up.
939933|NCT00980655|E4|Reported Event|23vPS Dose|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, followed by single 0.5 mL dose of 23vPS intramuscular injection at 1 month after 13vPnC Dose 4, were assessed from 23vPS Dose to the blood draw 1 month after 23vPS Dose.
939934|NCT00980655|E3|Reported Event|13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from 13vPnC Dose 4 to the blood draw 1 month after 13vPnC Dose 4.
939935|NCT00980655|E2|Reported Event|13vPnC Dose 3 Blood Draw to 13vPnC Dose 4|All participants aged 2 years and above who received 4 single 0.5 mL doses of 13vPnC intramuscular injections, 13vPnC Doses 1 to 3 at 1-month intervals and 13vPnC Dose 4 at 6 months after 13vPnC Dose 3, were assessed from blood draw 1 month after 13vPnC Dose 3 to prior to administration of 13vPnC Dose 4.
939940|NCT00980642|P2|Participant Flow|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
939944|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
939945|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
939946|NCT00980642|O2|Outcome|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
939947|NCT00980642|O1|Outcome|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery
939948|NCT00980642|E2|Reported Event|Regional Anesthesia|Temperature is measured by Draeger double-sensor and Foley catheter temperature sensor every 5-min during the surgery.
939949|NCT00980642|E1|Reported Event|General Anesthesia|Temperature is measured by Draeger double-sensor and esophageal stethoscope temperature sensor every 5-min during the surgery.
939950|NCT00980590|B3|Baseline|Total|Total of all reporting groups
939951|NCT00980590|B2|Baseline|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
939952|NCT00980590|B1|Baseline|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
939953|NCT00980590|P2|Participant Flow|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
939954|NCT00980590|P1|Participant Flow|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
939955|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
939956|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
939957|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
939958|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
939959|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
939960|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
939961|NCT00980590|O2|Outcome|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
939962|NCT00980590|O1|Outcome|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
939963|NCT00980590|E2|Reported Event|Macintosh Laryngoscope|"Intubation with Macintosh laryngoscope~Macintosh Laryngoscope: Tracheal intubation by Macintosh Laryngoscope"
939964|NCT00980590|E1|Reported Event|Airway Scope|"Intubation with Airway Scope~Airway Scope: Tracheal intubation by Airway Scope"
939965|NCT00980330|B8|Baseline|Total|Total of all reporting groups
939968|NCT00980330|B5|Baseline|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
939969|NCT00980330|B4|Baseline|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
939970|NCT00980330|B3|Baseline|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939971|NCT00980330|B2|Baseline|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
939972|NCT00980330|B1|Baseline|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
939973|NCT00980330|P7|Participant Flow|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939974|NCT00980330|P6|Participant Flow|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939975|NCT00980330|P5|Participant Flow|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
939976|NCT00980330|P4|Participant Flow|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
939977|NCT00980330|P3|Participant Flow|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939978|NCT00980330|P2|Participant Flow|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
939979|NCT00980330|P1|Participant Flow|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
939980|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939981|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
939982|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
939983|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939984|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940139|NCT00980148|O1|Outcome|Azithromycin Arm|Azithromycin 1 gm oral single dose
939985|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
939986|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939987|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
939988|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
939989|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939990|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
939991|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
939992|NCT00980330|O7|Outcome|All TMC435|Participants in all 6 TMC435 treatment groups combined.
939993|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939994|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
939995|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
939996|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
939997|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
939998|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
939999|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940000|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940161|NCT00980044|E3|Reported Event|Tramadol 600 mg|Medication: Extended release tramadol 600 mg daily for one week followed by placebo for one week
940001|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940002|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940003|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940004|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940005|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940006|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940007|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940008|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940009|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940010|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940011|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940012|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940013|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940014|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940015|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940016|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940017|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940140|NCT00980148|E2|Reported Event|Doxycycline Arm|Doxycycline 100 mg oral twice a day for 7 days
940018|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940019|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940020|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940021|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940022|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940023|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940024|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940025|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940026|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940027|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940028|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940029|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940030|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940031|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940032|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940033|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940034|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940035|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940036|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940037|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940038|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940039|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940040|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940041|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940042|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940043|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940044|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940045|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940046|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940047|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940048|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940049|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940050|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940051|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940052|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940053|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940054|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940055|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940056|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940057|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940058|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940059|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940060|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940061|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940062|NCT00980330|O7|Outcome|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940063|NCT00980330|O6|Outcome|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940064|NCT00980330|O5|Outcome|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940065|NCT00980330|O4|Outcome|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940066|NCT00980330|O3|Outcome|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940067|NCT00980330|O2|Outcome|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940162|NCT00980044|E2|Reported Event|Placebo|Medication: Placebo for 2 weeks
941160|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
940068|NCT00980330|O1|Outcome|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940069|NCT00980330|E7|Reported Event|Placebo 48Wks + PR48|Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940070|NCT00980330|E6|Reported Event|TMC435 150mg 48 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940071|NCT00980330|E5|Reported Event|TMC435 150mg 24 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
940072|NCT00980330|E4|Reported Event|TMC435 150mg 12 Wks + PR48|Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
940073|NCT00980330|E3|Reported Event|TMC435 100mg 48 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
940074|NCT00980330|E2|Reported Event|TMC435 100mg 24 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
940075|NCT00980330|E1|Reported Event|TMC435 100mg 12 Wks + PR48|Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
940076|NCT00980278|B3|Baseline|Total|Total of all reporting groups
940077|NCT00980278|B2|Baseline|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940078|NCT00980278|B1|Baseline|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940101|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940079|NCT00980278|P2|Participant Flow|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940080|NCT00980278|P1|Participant Flow|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940081|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940082|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940083|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940084|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940163|NCT00980044|E1|Reported Event|Tramadol 200 mg|Medication: Extended release tramadol 200 mg daily for one week followed by placebo for one week
940164|NCT00980005|B3|Baseline|Total|Total of all reporting groups
940215|NCT00979953|P1|Participant Flow|ADL5859|One 50-milligrams (mg) ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally twice daily (BID) for 14 days
940085|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940086|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940087|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940088|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940089|NCT00980278|O2|Outcome|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940090|NCT00980278|O1|Outcome|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940091|NCT00980278|E2|Reported Event|Sinus Lift Plus BRCs and Dental Implant|"transalveolar sinus augmentation will be performed. A unit dose of BRC (10 ml) will be mixed with a commercially available β-TCP (Cerasorb), which will be used as a carrier to deliver the cells.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: Aastrom BRCs, sinus augmentation, BRC application, dental implant~Aastrom BRCs: sinus augmentation, BRC application, dental implant"
940092|NCT00980278|E1|Reported Event|Sinus Lift Plus Dental Implant|"Transalveolar sinus augmentation will be performed. After 4 months dental implants will be delivered only if primary stability can be achieved.~Intervention (Procedure/Surgery): Sinus lift augmentation and dental implant transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved.~Biological/Vaccine: N/A; only sinus augmentation and dental implant~Sinus lift augmentation and dental implant: transalveolar sinus augmentation will be performed. After 4 months, dental implants will be delivered only if primary stability can be achieved."
940093|NCT00980200|B1|Baseline|PB, GW642444 6.25 µg QD, 6.25 µg BID, 12.5 µg QD, and 25 µg QD|All participants received one of the following five treatments in one of the five Treatment Periods from two DPI dispensed on Day 1of each of the five 7-day treatment periods: Placebo (PB), GW642444 6.25 µg once daily (QD) in the evening, GW642444 6.25 µg twice daily (BID), GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening. Participants received their first evening medication dose in the clinic on Day 1 of each of the five treatment periods. The treatments were administered in the morning (AM) and in the evening (PM), approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a 7-day washout period.
940094|NCT00980200|P5|Participant Flow|Sequence 5: 25 µg QD, 12.5 µg QD, 6.25 µg BID, 6.25 µg QD, Pbo|Participants received GW642444 25 µg QD in the evening, GW642444 12.5 µg QD in the evening, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, and placebo in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
940095|NCT00980200|P4|Participant Flow|Sequence 4: 12.5 µg QD, 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID|Participants received GW642444 12.5 µg QD in the evening, GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, and GW642444 6.25 µg BID and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
940210|NCT00979953|B2|Baseline|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
941161|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
940096|NCT00980200|P3|Participant Flow|Sequence 3: 6.25 µg QD, 25 µg QD, Pbo, 6.25 µg BID, 12.5 µg QD|Participants received GW642444 6.25 µg QD in the evening, GW642444 25 µg QD in the evening, placebo, GW642444 6.25 µg BID, and GW642444 12.5 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
940097|NCT00980200|P2|Participant Flow|Sequence 2: Pbo, 6.25 µg BID, 6.25 µg QD, 12.5 µg QD, 25 µg QD|Participants received placebo, GW642444 6.25 µg BID, GW642444 6.25 µg QD in the evening, GW642444 12.5 µg QD in the evening, and GW642444 25 µg QD in the evening and in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a DPI for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
940098|NCT00980200|P1|Participant Flow|Sequence 1: 6.25 µg BID, Pbo, 12.5 µg QD, 25 µg QD, 6.25 µg QD|Participants received GW642444 6.25 micrograms (µg) twice a day (BID), placebo (pbo), GW642444 12.5 µg once a day (QD) in the evening, GW642444 25 µg QD in the evening, and GW642444 6.25 µg QD in the evening in Treatment Periods 1, 2, 3, 4, and 5 respectively. Participants received all treatments from a Dry Powder Inhaler (DPI) for 7 days. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. The five treatment periods were separated by a washout period of at least 7 days.
940099|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940100|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940129|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
940102|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940103|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
940104|NCT00980200|O5|Outcome|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940105|NCT00980200|O4|Outcome|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940106|NCT00980200|O3|Outcome|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940107|NCT00980200|O2|Outcome|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940108|NCT00980200|O1|Outcome|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
940211|NCT00979953|B1|Baseline|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
940212|NCT00979953|P4|Participant Flow|Placebo|Four placebo capsules administered orally BID for 14 days
940109|NCT00980200|E5|Reported Event|GW642444 25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940110|NCT00980200|E4|Reported Event|GW642444 12.5 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 12.5 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940111|NCT00980200|E3|Reported Event|GW642444 6.25 µg BID|Participants received 2 actuations per day for during one of the five 7-day Treatment Periods from two separate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg in the morning and a second actuation in the evening. The treatments were administered approximately 12 hours apart. All participants took blinded treatment every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940112|NCT00980200|E2|Reported Event|GW642444 6.25 µg QD|Participants received 2 actuations per day (AM and PM) during one of the five 7-day Treatment Periods from two seperate DPIs starting with their first dose on the evening of Day 1. Participants received one actuation of GW642444 6.25 µg and another actuation of placebo. The treatments were administered approximately 12 hours apart. All participants took blinded treatment (active or placebo) every 12 hours, and therefore followed a 12-hour dosing interval. Each treatment period was followed by a 7-day washout period.
940113|NCT00980200|E1|Reported Event|Placebo|Participants received 2 placebo actuations per day during one of the five 7-day Treatment Periods. Participants received treatment in the morning (AM) and evening (PM), approximately 12 hours apart, from two seperate DPIs starting with their first dose on the evening of Day 1. Each treatment period was followed by a 7-day washout period.
940114|NCT00980174|B3|Baseline|Total|Total of all reporting groups
940115|NCT00980174|B2|Baseline|Denosumab 60 mg Q6M|
940116|NCT00980174|B1|Baseline|Placebo|
940117|NCT00980174|P2|Participant Flow|Denosumab 60 mg Q6M|
940118|NCT00980174|P1|Participant Flow|Placebo|
940119|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
940120|NCT00980174|O1|Outcome|Placebo|
940121|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
940122|NCT00980174|O1|Outcome|Placebo|
940123|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
940124|NCT00980174|O1|Outcome|Placebo|
940125|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
940126|NCT00980174|O1|Outcome|Placebo|
940127|NCT00980174|O2|Outcome|Denosumab 60 mg Q6M|
940128|NCT00980174|O1|Outcome|Placebo|
940141|NCT00980148|E1|Reported Event|Azithromycin Arm|Azithromycin 1 gm oral single dose
940142|NCT00980044|B4|Baseline|Total|Total of all reporting groups
940143|NCT00980044|B3|Baseline|Tramadol 600 mg|Medication: Extended release tramadol 600 mg given for 1 week and then placebo given for 1 week
940144|NCT00980044|B2|Baseline|Placebo|Medication: Placebo given for two weeks
940145|NCT00980044|B1|Baseline|Tramadol 200 mg|Medication: Extended release tramadol for 1 week and then placebo given for 1 week
940146|NCT00980044|P3|Participant Flow|Tramadol 600 mg Daily|Medication: Extended release tramadol 600 mg daily given for 1 week followed by 1 week of placebo dosing.
940147|NCT00980044|P2|Participant Flow|Placebo|Placebo given for two weeks
940148|NCT00980044|P1|Participant Flow|Tramadol 200 mg Daily|Medication: Extended release tramadol 200 mg daily given for 1 week then placebo given for 1 week
940149|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
940150|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
940151|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
940152|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
940153|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
940154|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
940155|NCT00980044|O3|Outcome|Tramadol 600 mg Then Placebo|"Tramadol 600 mg daily given for 1 week given then placebo given for 1 week~Tramadol: Oral Medication"
940156|NCT00980044|O2|Outcome|Placebo for Two Weeks|"Medication~Placebo: Oral Medication"
940157|NCT00980044|O1|Outcome|Tramadol 200 mg Then Placebo|"Tramadol 200 mg daily for 1 week then placebo given for 1 week~Tramadol: Oral Medication"
940158|NCT00980044|O3|Outcome|Tramadol 600 mg Daily|Medication: Extended release tramadol
940159|NCT00980044|O2|Outcome|Placebo|Medication
940160|NCT00980044|O1|Outcome|Tramadol 200 mg Daily|Medication: Extended release tramadol
940165|NCT00980005|B2|Baseline|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940166|NCT00980005|B1|Baseline|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940167|NCT00980005|P2|Participant Flow|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940168|NCT00980005|P1|Participant Flow|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940169|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940170|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940171|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940172|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940173|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940174|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940175|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940176|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940177|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940240|NCT00979901|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940178|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940179|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940180|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940181|NCT00980005|O4|Outcome|Fluzone 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
940182|NCT00980005|O3|Outcome|Flulaval 5 Years of Age and Older Group|Subjects aged 5 years and above and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
940183|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940184|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940185|NCT00980005|O4|Outcome|Fluzone Les Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age
940186|NCT00980005|O3|Outcome|Flulaval Less Than 5 Years Old Group|Subjects below 5 years of age and who received 1 or 2 injections of Flulaval™ vaccine according to their priming status.
940213|NCT00979953|P3|Participant Flow|Oxycodone CR|One 10-mg Oxycodone controlled release (CR) capsule and 3 placebo capsules administered orally BID Days 1 through 4 One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14
940187|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940188|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940189|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940190|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940191|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940192|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940193|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940194|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940195|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940196|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940197|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940198|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940199|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940200|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940201|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940202|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940203|NCT00980005|O2|Outcome|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940204|NCT00980005|O1|Outcome|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940205|NCT00980005|E2|Reported Event|Fluzone Group|"subjects received Fluzone® Sanofi Pasteur’s vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Fluzone vaccine was administered intramuscularly into the non-dominant deltoid."
940206|NCT00980005|E1|Reported Event|Flulaval Group|"subjects received Flulaval™ vaccine according to their priming status and age:~3-8 years: primed subjects 1 dose at Day 0; unprimed subjects 1 dose at Day 0 and a second dose at Day 28~9-17 years: 1 dose at Day 0 Flulaval vaccine was administered intramuscularly into the non-dominant deltoid."
940207|NCT00979953|B5|Baseline|Total|Total of all reporting groups
940208|NCT00979953|B4|Baseline|Placebo|Four placebo capsules administered orally BID for 14 days
940209|NCT00979953|B3|Baseline|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
940216|NCT00979953|O4|Outcome|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
940217|NCT00979953|O3|Outcome|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
940218|NCT00979953|O2|Outcome|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID for Days 5 through 14"
940219|NCT00979953|O1|Outcome|Placebo|Four placebo capsules administered orally BID for 14 days
940220|NCT00979953|E4|Reported Event|Placebo|Four placebo capsules administered orally BID for 14 days
940221|NCT00979953|E3|Reported Event|Oxycodone CR|"One 10-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 1 through 4~One 20-mg Oxycodone CR capsule and 3 placebo capsules administered orally BID Days 5 through 14"
940222|NCT00979953|E2|Reported Event|ADL5747|One 150-mg ADL5747 capsule and 3 placebo capsules administered orally BID for 14 days
940223|NCT00979953|E1|Reported Event|ADL5859|One 50-mg ADL5859 capsule, one 100-mg ADL5859 capsule, and 2 placebo capsules administered orally BID for 14 days
940224|NCT00979940|B3|Baseline|Total|Total of all reporting groups
940225|NCT00979940|B2|Baseline|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
940226|NCT00979940|B1|Baseline|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
940227|NCT00979940|P2|Participant Flow|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
940228|NCT00979940|P1|Participant Flow|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
940229|NCT00979940|O2|Outcome|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
940230|NCT00979940|O1|Outcome|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
940231|NCT00979940|E2|Reported Event|Atorvastatin|"Atorvastatin 80mg po given prior to PCI in cath lab~Atorvastatin: Atorvastatin 80mg po given one time before PCI in cath lab."
940232|NCT00979940|E1|Reported Event|No Atorvastatin|Patients do not receive Atorvastatin prior to PCI in cath lab
940233|NCT00979901|B5|Baseline|Total|Total of all reporting groups
940234|NCT00979901|B4|Baseline|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
940235|NCT00979901|B3|Baseline|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940236|NCT00979901|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940237|NCT00979901|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940238|NCT00979901|P4|Participant Flow|Montelukast/Loratadine|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
940239|NCT00979901|P3|Participant Flow|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940241|NCT00979901|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940242|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940243|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940244|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940245|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940246|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940247|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940248|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940249|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940250|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940251|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940252|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940253|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940254|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940255|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940256|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940257|NCT00979901|O3|Outcome|Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940258|NCT00979901|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940259|NCT00979901|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940260|NCT00979901|E4|Reported Event|Montelukast 10 mg + Loratadine 10 mg|Montelukast matching-image placebo tablet, loratadine matching-image placebo tablet, and montelukast 10 mg/loratadine 10 mg combination tablet taken orally once daily at bedtime for 2 weeks. During the study, patients in the montelukast/loratadine combination treatment group were discontinued from further participation due to a business decision by the sponsor.
940261|NCT00979901|E3|Reported Event|Loratadine 10mg|Montelukast matching-image placebo tablet, loratadine 10 mg tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940262|NCT00979901|E2|Reported Event|Montelukast 10mg|Montelukast 10 mg tablet, loratadine matching-image placebo tablet, and montelukast/loratadine matching-image placebo tablet taken orally once daily at bedtime for 2 weeks.
940263|NCT00979901|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination taken orally once daily at bedtime for 2 weeks.
940264|NCT00979875|B1|Baseline|Overall Study|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C). Each intervention was separated by a 3- to 14-day washout.~Intervention A: Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20) and a single, SC injection of 95 U/mL Lispro alone 3 to 14 days apart.~Intervention B: Participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Glulis alone 3 to 14 days apart.~Intervention C: Participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20 and a single, SC injection of 95 U/mL Aspart alone 3 to 14 days apart."
940265|NCT00979875|P6|Participant Flow|Aspart, Aspart+PH20, Lispro, Lispro+PH20, Glulis+PH20, Glulis|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone."
940288|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
940289|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940290|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
940266|NCT00979875|P5|Participant Flow|Aspart+PH20, Aspart, Glulis+PH20, Glulis, Lispro, Lispro+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) + 5 µg/mL PH20. Then, 3 to 14 days later, participants received and a single, SC injection of 95 U/mL Glulisine alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20."
940267|NCT00979875|P4|Participant Flow|Glulis, Glulis+PH20, Aspart+PH20, Aspart, Lispro+PH20, Lispro|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone.~After a 3- to 14-day washout, participants received a single, subcutaneous (SC) injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone."
940268|NCT00979875|P3|Participant Flow|Lispro, Lispro+PH20, Aspart, Aspart+PH20, Glulis, Glulis+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20).~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20."
940269|NCT00979875|P2|Participant Flow|Glulis+PH20, Glulis, Lispro+PH20, Lispro, Aspart+PH20, Aspart|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Glulisine (Glulis) + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Lispro + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart alone."
941162|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
940270|NCT00979875|P1|Participant Flow|Lispro+PH20, Lispro, Glulis, Glulis+PH20, Aspart, Aspart+PH20|"Participants received a single, subcutaneous (SC) injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (PH20). Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Lispro alone.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Glulisine (Glulis) alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Glulis + 5 µg/mL PH20.~After a 3- to 14-day washout, participants received a single, SC injection of 95 U/mL Aspart alone. Then, 3 to 14 days later, participants received a single, SC injection of 95 U/mL Aspart + 5 µg/mL PH20."
940271|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940272|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
940273|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940274|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
940275|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940276|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
940277|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940278|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
940279|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940280|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
940281|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940282|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
940283|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940284|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
940285|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940286|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
940287|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
951437|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
940291|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940292|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
940293|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940294|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
940295|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940296|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
940297|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940298|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
940299|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940300|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
940301|NCT00979875|O6|Outcome|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940302|NCT00979875|O5|Outcome|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
940303|NCT00979875|O4|Outcome|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940304|NCT00979875|O3|Outcome|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
940305|NCT00979875|O2|Outcome|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940306|NCT00979875|O1|Outcome|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
940307|NCT00979875|E6|Reported Event|Aspart + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940308|NCT00979875|E5|Reported Event|Aspart Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Aspart alone.
940309|NCT00979875|E4|Reported Event|Lispro + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940310|NCT00979875|E3|Reported Event|Lispro Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Lispro alone.
940311|NCT00979875|E2|Reported Event|Glulisine + rHuPH20|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine + 5 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20 (rHuPH20).
940312|NCT00979875|E1|Reported Event|Glulisine Alone|Participants received a single, subcutaneous injection of 95 units per milliliter (U/mL) Glulisine alone.
940313|NCT00979654|B1|Baseline|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940314|NCT00979654|P1|Participant Flow|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940315|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940316|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940317|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940318|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940319|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940320|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940408|NCT00979420|B1|Baseline|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940321|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940322|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940323|NCT00979654|O1|Outcome|Sifalimumab (MEDI-545) 500 or 600 Milligram (mg)|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940324|NCT00979654|E1|Reported Event|MEDI-545|All participants received intravenous (IV) sifalimumab as fixed dose of 500 mg every 2 weeks (Q2W) on Day 1, Week 2, and Week 4, then every 4 weeks (Q4W) thereafter for a total of 156 weeks. The initial fixed dose of 500 mg was increased to 600 mg with subsequent protocol amendment.
940325|NCT00979628|B4|Baseline|Total|Total of all reporting groups
940326|NCT00979628|B3|Baseline|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) given subcut four-times daily before meals and at bedtime"
940327|NCT00979628|B2|Baseline|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily subcut at an initial dose of 0.15-0.25 units/kg/day plus corrective doses of glulisine subcut before meals and bedtime as needed"
940328|NCT00979628|B1|Baseline|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals subcut at an initial dose of 0.3-0.5 unitws/kg/day (plus corrective doses of glulisine as needed)"
940329|NCT00979628|P3|Participant Flow|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI) : four-time daily in patients with T2DM admitted to general medicine and surgery wards."
941163|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
940330|NCT00979628|P2|Participant Flow|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus : glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
940331|NCT00979628|P1|Participant Flow|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus : glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
940332|NCT00979628|O3|Outcome|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
940333|NCT00979628|O2|Outcome|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
940334|NCT00979628|O1|Outcome|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
940335|NCT00979628|E3|Reported Event|Sliding Scale Regular Insulin (SSRI)|"four-time daily in patients with T2DM admitted to general medicine and surgery wards.~sliding scale regular insulin (SSRI): four-time daily in patients with T2DM admitted to general medicine and surgery wards."
940336|NCT00979628|E2|Reported Event|Basal Bolus|"glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)~Basal Bolus: glargine once daily plus glulisine before meals (plus corrective doses of glulisine as needed)"
940337|NCT00979628|E1|Reported Event|Basal Plus Regimen|"glargine once daily plus corrective doses of glulisine before meals and bedtime as needed~Basal Plus: glargine once daily plus corrective doses of glulisine before meals and bedtime as needed"
940338|NCT00979615|B3|Baseline|Total|Total of all reporting groups
940339|NCT00979615|B2|Baseline|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940340|NCT00979615|B1|Baseline|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940341|NCT00979615|P2|Participant Flow|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940342|NCT00979615|P1|Participant Flow|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940343|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940344|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940345|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940346|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940347|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940348|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940349|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940350|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940351|NCT00979615|O2|Outcome|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940352|NCT00979615|O1|Outcome|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940353|NCT00979615|E2|Reported Event|Azelastine HCl|Azelastine HCl Nasal Spray, 137 mcg
940354|NCT00979615|E1|Reported Event|Olopatadine HCL|Olopatadine HCL Nasal Spray, 0.6%
940355|NCT00979576|B4|Baseline|Total|Total of all reporting groups
940356|NCT00979576|B3|Baseline|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940405|NCT00979420|B4|Baseline|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940357|NCT00979576|B2|Baseline|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940358|NCT00979576|B1|Baseline|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940359|NCT00979576|P3|Participant Flow|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940360|NCT00979576|P2|Participant Flow|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940361|NCT00979576|P1|Participant Flow|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940362|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
940363|NCT00979576|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2 administered by intravenous infusion taken in combination with oral administration of BIBF 1120 100mg, 150mg or 200mg b.i.d..
940364|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940365|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940366|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940367|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940368|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940369|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940370|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940371|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940372|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940373|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940374|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940375|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940376|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940377|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940378|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940379|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940380|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940381|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940382|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940406|NCT00979420|B3|Baseline|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940407|NCT00979420|B2|Baseline|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
951438|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
940383|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940384|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940385|NCT00979576|O3|Outcome|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940386|NCT00979576|O2|Outcome|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940387|NCT00979576|O1|Outcome|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940423|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940424|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
941164|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
940388|NCT00979576|E3|Reported Event|BIBF 1120 200 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 200 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940389|NCT00979576|E2|Reported Event|BIBF 1120 150 mg + Pemetrexed 500 mg/m^2|"Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 150 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles.~In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses."
940390|NCT00979576|E1|Reported Event|BIBF 1120 100 mg + Pemetrexed 500 mg/m^2|Treatments were administered in 21 day courses. Patients received pemetrexed 500 mg/m^2 administered by intravenous infusion on day 1 and BIBF 1120 (nintedanib) 100 mg administered orally once on day 2 and twice daily (b.i.d.) from day 3 to day 21 in cycle 1 and b.i.d. from day 2 to day 21 in further cycles. In case that a patient had to discontinue pemetrexed, the patient was allowed to continue nintedanib monotherapy if the patient had been treated with the nintedanib combination therapy with pemetrexed for at least 4 courses.
940391|NCT00979459|B1|Baseline|All Participants|Includes participants who were randomized to receive either a single dose of four 20 mg MK-1006 DFC followed by a single dose of two 40 mg MK-1006 FCT or a single dose of four 20 mg MK-1006 FCT followed by a single dose of two 40 mg MK-1006 DFC
940392|NCT00979459|P2|Participant Flow|MK-1006 FCT, Then MK-1006 DFC|Participants received a single dose of two 40 mg film coated tablets (FCT) of MK-1006 followed by a single dose of four 20 mg MK-1006 dry filled capsules (DFC) after a 7 day washout period.
940393|NCT00979459|P1|Participant Flow|MK-1006 DFC, Then MK-1006 FCT|Participants received a single dose of four 20 mg MK-1006 dry filled capsules (DFC) followed by a single dose of two 40 mg MK-1006 film coated tablets (FCT) after a 7 day washout period.
940394|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
940395|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
940396|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
940397|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
940398|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
940399|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
940400|NCT00979459|O2|Outcome|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg DFC
940401|NCT00979459|O1|Outcome|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg FCT
940402|NCT00979459|E2|Reported Event|MK-1006 80 mg DFC|Participants received a single dose of four MK-1006 20 mg dry filled capsules
940403|NCT00979459|E1|Reported Event|MK-1006 80 mg FCT|Participants received a single dose of two MK-1006 40 mg film coated tablets
940404|NCT00979420|B5|Baseline|Total|Total of all reporting groups
940409|NCT00979420|P4|Participant Flow|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940410|NCT00979420|P3|Participant Flow|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940411|NCT00979420|P2|Participant Flow|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|HIV RNA denotes Human immunodeficiency virus (HIV) Ribonucleic acid (RNA). Baseline reflects the last available documentation before start of treatment with Viramune
940412|NCT00979420|P1|Participant Flow|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940413|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940414|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940415|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940416|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940417|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940418|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940419|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940420|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940421|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940422|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940425|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940426|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA <50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940427|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940428|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940429|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940430|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940431|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940432|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940433|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940434|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940435|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940436|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940437|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940438|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940439|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940440|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940441|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940442|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940443|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940444|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940445|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940446|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940447|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940448|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940449|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940450|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940451|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940452|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940453|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940454|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940455|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940456|NCT00979420|O4|Outcome|Pre-treated Patients With Baseline HIV RNA Not Documented|Baseline reflects the last available documentation before start of treatment with Viramune
940457|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940458|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940459|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940460|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940461|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940462|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940463|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940464|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940465|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940466|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940467|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940468|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940469|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940470|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940471|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940472|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940473|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940474|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940475|NCT00979420|O3|Outcome|Pre-treated Patients With Baseline HIV RNA>=50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940476|NCT00979420|O2|Outcome|Pre-treated Patients With Baseline HIV RNA<50 Copies/ml|Baseline reflects the last available documentation before start of treatment with Viramune
940477|NCT00979420|O1|Outcome|Treatment-naive Patients|Patient was not treated with any antiretroviral drugs (ARV) before start of therapy with Viramune
940478|NCT00979420|E1|Reported Event|Viramune|
940479|NCT00979212|B3|Baseline|Total|Total of all reporting groups
940480|NCT00979212|B2|Baseline|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940481|NCT00979212|B1|Baseline|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940482|NCT00979212|P2|Participant Flow|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940483|NCT00979212|P1|Participant Flow|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940484|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940485|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940486|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940487|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940488|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940489|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940490|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940491|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940492|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940493|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940494|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940495|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940496|NCT00979212|O2|Outcome|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940497|NCT00979212|O1|Outcome|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940498|NCT00979212|E2|Reported Event|Induction CT+RT+Panitumumab|Panitumumab plus chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940499|NCT00979212|E1|Reported Event|Induction CT+RT|Chemotherapy (paclitaxel and carboplatin) plus radiation therapy followed by surgery (if operable) followed by consolidation chemotherapy (paclitaxel and carboplatin)
940500|NCT00979199|B1|Baseline|CTCA and PET or SPECT and ECHO or MRI|
940501|NCT00979199|P1|Participant Flow|CTCA and PET or SPECT and ECHO or MRI|
940548|NCT00978757|E1|Reported Event|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
940502|NCT00979199|O1|Outcome|Non Invasive Cardiac Imaging|All patients are submitted to non invasive cardiac imaging. 'Anatomical' information provided by CTA is obtained in every patient together with the 'functional' information provided by stress radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by stress MRI or ECHO imaging to assess myocardial contraction. All patients with at least one positive functional test undergo invasive coronary angiography to obtain the final diagnosis of IHD (Outcome measurement).
940503|NCT00979199|E1|Reported Event|Non Invasive Cardiac Imaging|
940504|NCT00979121|B3|Baseline|Total|Total of all reporting groups
940505|NCT00979121|B2|Baseline|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
940506|NCT00979121|B1|Baseline|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
940507|NCT00979121|P2|Participant Flow|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
940508|NCT00979121|P1|Participant Flow|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
940509|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
940510|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin:Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
940511|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
940512|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
940513|NCT00979121|O2|Outcome|Placebo|"Half of the patients will be randomized to the placebo.~Placebo: Patients will receive one placebo by mouth or feeding tube daily for 28 days or until discharged form study hospital."
940514|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects will receive the active drug, Rosuvastatin.~Rosuvastatin: Patients will receive 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharged from the study hospital."
940515|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
940516|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Patients received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
940517|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharged from study hospital."
940518|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
940519|NCT00979121|O2|Outcome|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
940520|NCT00979121|O1|Outcome|Rosuvastatin|"Half of the subjects were randomized to active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
940840|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
951439|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
940521|NCT00979121|E2|Reported Event|Placebo|"Half of the subjects were randomized to placebo.~Placebo: Subjects received placebo by mouth or feeding tube daily for 28 days or until discharge from study hospital."
940522|NCT00979121|E1|Reported Event|Rosuvastatin|"Half of the subjects were randomized to the active drug (Rosuvastatin).~Rosuvastatin: Subjects received 20 mg of study drug daily by mouth or feeding tube for 28 days or until discharge from the study hospital."
940523|NCT00979069|B3|Baseline|Total|Total of all reporting groups
940524|NCT00979069|B2|Baseline|Control Group|No contact control
940525|NCT00979069|B1|Baseline|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
940526|NCT00979069|P2|Participant Flow|Control Group|No contact control
940527|NCT00979069|P1|Participant Flow|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
940528|NCT00979069|O2|Outcome|Control Group|No contact control
940529|NCT00979069|O1|Outcome|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
940530|NCT00979069|E2|Reported Event|Control Group|No contact control
940531|NCT00979069|E1|Reported Event|Aerobic Group|"12 weeks of aerobic exercise 3 times a week~Aerobic group: 12 weeks of aerobic exercise 3 times a week"
940532|NCT00979017|B1|Baseline|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940549|NCT00978731|B5|Baseline|Total|Total of all reporting groups
940704|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940533|NCT00979017|P1|Participant Flow|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940534|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940535|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940536|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940585|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940537|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940538|NCT00979017|O1|Outcome|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940539|NCT00979017|E1|Reported Event|Avastin in Combination With Temozolomide and Irinotecan|"Avastin 10 mg/kg every 14 days. Temozolomide 200 mg/m2 daily x 5 days in a 28-day cycle. Irinotecan dose depends on whether the patient is on an enzyme-inducing antiepileptic drug (EIAED). EIAED 340 mg/m2 every other week and no EIAED 125 mg/m2 every other week. Irinotecan dose also depends on if the patient has the UGT 1A1 polymorphism (7/7). If so, they do not metabolize the irinotecan normally, so these patients will start out at a two dose level reduction. EIAED starting dose will be 275 mg/m2 and no EIAED starting dose will be 75 mg/ m2.~Avastin in combination with temozolomide and irinotecan : Avastin, by intravenous infusion, 10 mg/kg every 14 days in combination with oral temozolomide at 200 mg/m2 daily for 5 days and irinotecan, by intravenous infusion, every other week (dose dependent upon if taking enzyme-inducing anti-epileptic drugs or if a blood test indicates the patient has the UGT 1A1 polymorphism)"
940540|NCT00978757|B3|Baseline|Total|Total of all reporting groups
940541|NCT00978757|B2|Baseline|Placebo|Placebo: saline solution
940542|NCT00978757|B1|Baseline|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
940543|NCT00978757|P2|Participant Flow|Placebo|Placebo: saline solution
940544|NCT00978757|P1|Participant Flow|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
940545|NCT00978757|O2|Outcome|Placebo|Placebo: saline solution
940546|NCT00978757|O1|Outcome|Ketamine|Ketamine: 0.25 mg/kg, intravenously, one dose.
940547|NCT00978757|E2|Reported Event|Placebo|Placebo: saline solution
940550|NCT00978731|B4|Baseline|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940551|NCT00978731|B3|Baseline|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940552|NCT00978731|B2|Baseline|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940553|NCT00978731|B1|Baseline|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940554|NCT00978731|P4|Participant Flow|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940555|NCT00978731|P3|Participant Flow|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940556|NCT00978731|P2|Participant Flow|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940557|NCT00978731|P1|Participant Flow|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940558|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
940559|NCT00978731|O1|Outcome|All Participants|All participants treated in each arm of the study were included.
940560|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940611|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940798|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940561|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940562|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940563|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940564|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940565|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940841|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
940566|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940567|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940568|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940569|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940570|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
951309|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
940571|NCT00978731|O2|Outcome|Participants With CML: BID Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940572|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940573|NCT00978731|O1|Outcome|Participants With Chronic Myelogenous Leukemia (CML)|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). QD dosing: TDD of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken QD. BID dosing: Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940574|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940599|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940600|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
951440|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
940575|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940576|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940577|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940578|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940579|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940580|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
941165|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
940581|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940582|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940583|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940584|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940586|NCT00978731|O4|Outcome|Myeloid Blast Phase CML: BID Dosing at Study Entry|Participants with myeloid blast phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940587|NCT00978731|O3|Outcome|Accelerated Phase CML: BID Dosing at Study Entry|Participants with accelerated phase CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940588|NCT00978731|O2|Outcome|CML: BID Dosing at Study Entry|Participants with CML were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg dasatinib. Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940589|NCT00978731|O1|Outcome|Chronic Myelogenous Leukemia (CML): QD Dosing at Study Entry|Participants with Chronic Myelogenous Leukemia (CML)were continued on the last dose and schedule of dasatinib that was received within the previous protocol CA180002 (NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules (5 days on, 2 days off; 6 days on, 1 day off or continuous daily dosing) and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940590|NCT00978731|E4|Reported Event|Participants With Myeloid Blast Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940591|NCT00978731|E3|Reported Event|Participants With CML; BID Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). Treatment was received BID, with a TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg. Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940592|NCT00978731|E2|Reported Event|Participants With Chronic Myelogenous Leukemia(CML);QD Dosing|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A total daily dose (TDD) of 50 mg, 75 mg, 105 mg, 140 mg or 180 mg dasatinib was taken once daily (QD). Participants were dosed on 1 of 3 schedules: 5 days, on 2 days off; 6 days on, 1 day off; or continuous daily dosing. Participants were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to twice daily (BID) dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940593|NCT00978731|E1|Reported Event|Participants With Accelerated Phase CML|Participants continued on the last dose and schedule of dasatinib that was received within the previous protocol (CA180002; NCT00064233). A TDD of 50 mg, 75 mg, 105 mg, 120 mg, 140 mg or 180 mg dasatinib was taken QD or split into 2 doses and taken BID (TDD of 50 mg, 70 mg, 100 mg, 140 mg, 180 mg or 240 mg ). Participants were dosed on 1 of 3 schedules: 5 days on, 2 days off; 6 days on, 1 day off; or continuous daily dosing and were permitted to escalate or reduce by 1 dose level at a time, switch from QD dosing to BID dosing and vice versa provided they did not exceed a change of 1 dose level from the TDD. The weekly schedule was also permitted to be increased or decreased 1 level at a time.
940594|NCT00978627|B3|Baseline|Total|Total of all reporting groups
940595|NCT00978627|B2|Baseline|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940596|NCT00978627|B1|Baseline|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940597|NCT00978627|P2|Participant Flow|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940598|NCT00978627|P1|Participant Flow|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940782|NCT00977938|B3|Baseline|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940601|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940602|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940603|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940604|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940605|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940606|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940607|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940608|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940609|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940610|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
941166|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
940612|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940613|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940614|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940615|NCT00978627|O2|Outcome|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940616|NCT00978627|O1|Outcome|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940617|NCT00978627|E2|Reported Event|IDet|Insulin detemir (Idet) was given subcutaneously (s.c) once daily (OD) in the evening or twice daily (BID) in combination with mealtime insulin aspart (Iasp). The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940618|NCT00978627|E1|Reported Event|IDegAsp OD|Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) with a main meal in combination with mealtime insulin aspart (IAsp) for the remaining meals. The regimen was given for 26 weeks in the main period and for an additional 26 weeks in the extension period.
940619|NCT00978562|B1|Baseline|Diagnostic (DSC-MRI With Ferumoxytol, DCE-MRI With Gadolinium)|"Patients receive ferumoxytol and gadolinium IV and then undergo DSC-MRI and DCE-MRI. An optional MRI without injection of a contrast agent may be obtained after 20-24 hours at the discretion of the clinician. Patients may receive up to 3 more scans at least 3 weeks apart over up to 2 years.~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Undergo DCE-MRI~Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging: Undergo DSC-MRI~Ferumoxytol Non-Stoichiometric Magnetite: Given IV~Gadolinium: Given IV"
940620|NCT00978562|P1|Participant Flow|Ferumoxytol Dynamic Susceptibility (DSC) Weighted MRI and Gado|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
940621|NCT00978562|O1|Outcome|Gadolinium DCE|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
940622|NCT00978562|O1|Outcome|Ferumoxytol DSC MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
940623|NCT00978562|E1|Reported Event|Ferumoxytol DSC and Gad DCE MRI|Subjects undergo MRI with ferumoxytol (study drug) and gadolinium (standard contrast agent) in the same imaging session. Ferumoxytol is given first and DSC images obtained, followed by gadolinium, and DCE images are obtained.
940624|NCT00978445|B1|Baseline|All Participants|all participants recieved all interventions during study
940625|NCT00978445|P2|Participant Flow|Standard/Home|all participants recieved home and standard protocol, in this ARM the standard protocol was a in clinic INR and interaction with a care giver, then the Home protocol was as described.
940626|NCT00978445|P1|Participant Flow|Home/Standard|all participants recieved home and standard protocol, in this ARM the home protocol was a virtual INR and communication using a remote communication device called vMetrics.
940627|NCT00978445|O2|Outcome|All Participants - Standard Protocol|all participants recieved all interventions during study
940628|NCT00978445|O1|Outcome|All Participants-home Protocol|all participants recieved all interventions during study
940629|NCT00978445|O2|Outcome|All Particpants - Standard Protocol|First and second group with vMetrics
940630|NCT00978445|O1|Outcome|All Participants-Home Protocol|all participants recieved all interventions during study
940631|NCT00978445|E1|Reported Event|All Participants|all participants recieved all interventions during study
940632|NCT00978432|B4|Baseline|Total|Total of all reporting groups
940633|NCT00978432|B3|Baseline|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940634|NCT00978432|B2|Baseline|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940645|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940635|NCT00978432|B1|Baseline|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940636|NCT00978432|P3|Participant Flow|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940637|NCT00978432|P2|Participant Flow|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940638|NCT00978432|P1|Participant Flow|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940639|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940693|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940830|NCT00977769|P3|Participant Flow|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
940640|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940641|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940642|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940643|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940644|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940682|NCT00978120|B5|Baseline|Total|Total of all reporting groups
941167|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
940646|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940647|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940648|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940649|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940650|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940651|NCT00978432|O3|Outcome|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940652|NCT00978432|O2|Outcome|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940653|NCT00978432|O1|Outcome|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940654|NCT00978432|E3|Reported Event|Doublet (Combination RAD001 and LBH589)|"Subjects will receive the doublet of RAD001 and LBH589 given in two to thirteen, 28-day cycles. Subjects will be evaluated for the disease status after completion of cycle two and then after every 4 cycles. Subjects with progressive disease will stop after 2 cycles. Subjects with stable disease or better may receive up to 13 cycles. LBH589 will start at 15mg po three days a week at least 2 days apart such as on days M/W/F or T/Th/Sat and RAD001 will start at 7.5mg po daily.~Doublet (RAD001 and LBH589): RAD001 7.5 mg by mouth daily and LBH589 15 mg by mouth on Monday/Wednesday/Friday during Part 2."
940655|NCT00978432|E2|Reported Event|Arm 1b (LBH589 Followed by RAD001)|"Part 1b: Sequential single agent therapy with LBH589 and RAD001 . Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940799|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940656|NCT00978432|E1|Reported Event|Arm 1a (RAD001 Followed by LBH589)|"Part 1a: Sequential single agent therapy with RAD001 and LBH589. Each agent will be given for four-six 28-day cycles.~Subjects with less than a CR after 4 cycles of study drug should proceed to the next study drug(s) after the prescribed washout period.~Subjects with a CR may receive up to 6 cycles of study drug and will not receive the next study drug(s) until there is evidence of progressive disease.~There will be a 1-6 week ‘washout’ period between stopping and starting each agent in Part 1, unless rapid progression suggests holding therapy would not be in the patient’s best interest.~RAD001: 10 mg/day for Part 1 of the trial~LBH589: 40 mg on Monday, Wednesday and Friday weekly for Part 1 of the trial"
940657|NCT00978380|B1|Baseline|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
940658|NCT00978380|P1|Participant Flow|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
940659|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
940660|NCT00978380|O1|Outcome|Recombinant Factor XIII (rFXIII)|Subjects received 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) injection every 4 weeks (28 days±2 days) for a minimum period of 52 weeks until the end of trial visit. The dose was identical to the dose administered in the F13CD- 1725 trial. A total of 60 unique subjects were enrolled and exposed in the trial, but 3 of these subjects were later withdrawn and subsequently re-enrolled with new subject IDs, giving rise to a total of N=63 subjects. The unique subjects (N=60) were presented as full analysis set (FAS) while summarising adverse events to avoid double-counting.
940694|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940831|NCT00977769|P2|Participant Flow|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
940661|NCT00978380|E2|Reported Event|rFXIII Avecia|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Avecia drug.
940662|NCT00978380|E1|Reported Event|rFXIII Novo Nordisk|Subjects in this arm received identical dose of 35 IU/kg bodyweight of rFXIII slow intravenous (i.v.) administered every 4 weeks (28 days±2 days) until the end of trial for a minimum period of 52 weeks. In the early stage of the trial, a contract manufacturing facility (Avecia) produced the rFXIII drug substance (rFXIII Avecia) and subsequently, Novo Nordisk took over production of the rFXIII drug substance (rFXIII Novo Nordisk). Characterisation testing between the two products confirmed that rFXIII Novo Nordisk and rFXIII Avecia had identical structures, and similar physico-chemical properties. The AE data are presented seperately for rFXIII Novo Nordisk and rFXIII Avecia. However, subjects in this arm received rFXIII Novo Nordisk drug.
940663|NCT00978341|B1|Baseline|All Subjects|Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning; and Placebo: Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940664|NCT00978341|P2|Participant Flow|Placebo First Then Pregabalin|First Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning. Second Intervention Pregabalin: Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940665|NCT00978341|P1|Participant Flow|Pregabalin First Then Placebo|First Intervention Pregabalin Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning. Second Intervention Placebo Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940666|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940667|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940668|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940669|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940670|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940671|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940672|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940673|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940674|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940675|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940676|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940677|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940678|NCT00978341|O2|Outcome|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning
940679|NCT00978341|O1|Outcome|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940680|NCT00978341|E2|Reported Event|Placebo|Days 1-7: twice a day (BID); Day 8: 1 dose in the morning.
940681|NCT00978341|E1|Reported Event|Pregabalin|Days 1-7: 150 mg twice a day (BID); Day 8: 150 mg in the morning.
940683|NCT00978120|B4|Baseline|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940684|NCT00978120|B3|Baseline|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940685|NCT00978120|B2|Baseline|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
940686|NCT00978120|B1|Baseline|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940687|NCT00978120|P4|Participant Flow|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940688|NCT00978120|P3|Participant Flow|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940689|NCT00978120|P2|Participant Flow|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
940690|NCT00978120|P1|Participant Flow|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940691|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940692|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940695|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940696|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940697|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940698|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940699|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940700|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940701|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940702|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940703|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940705|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940706|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940707|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940708|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940709|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940710|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940711|NCT00978120|O2|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940712|NCT00978120|O1|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940713|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|"Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940714|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted[1], inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940738|NCT00978120|E1|Reported Event|Mild/Moderate Asthma, Low Dose Vaccine (15 Mcg)|Participants with mild/moderate asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940739|NCT00978042|B3|Baseline|Total|Total of all reporting groups
940715|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940716|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940717|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
940718|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940719|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940720|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940721|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
940722|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940723|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940724|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940725|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
940800|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940726|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940727|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940728|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940729|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
940730|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940731|NCT00978120|O4|Outcome|Severe Asthma, High Dose Vaccine (30mcg)|"Participants with severe asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.~[1] Unadjuvanted: No agents added to, or used in conjunction with, vaccine antigens to augment or potentiate (and possibly target) the specific immune response to the antigen. (U.S. Food And Drug Administration)"
940732|NCT00978120|O3|Outcome|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940733|NCT00978120|O2|Outcome|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild-to-moderate asthma received two 15 mcg doses of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injections on Day 1 and Day 21.
940734|NCT00978120|O1|Outcome|Mild/Moderate Asthma, Low Dose Vaccine (15mcg)|Participants with mild-to-moderate asthma received one 15 micrograms (mcg) dose of unadjuvanted,[1] inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940735|NCT00978120|E4|Reported Event|Severe Asthma, High Dose Vaccine (30mcg)|Participants with severe asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940736|NCT00978120|E3|Reported Event|Severe Asthma, Low Dose Vaccine (15mcg)|Participants with severe asthma received one 15 mcg dose of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940737|NCT00978120|E2|Reported Event|Mild/Moderate Asthma, High Dose Vaccine (30mcg)|Participants with mild/moderate asthma received two 15 mcg doses of unadjuvanted, inactivated Novartis H1N1 pandemic influenza vaccine by intramuscular injection on Day 1 and Day 21.
940832|NCT00977769|P1|Participant Flow|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
940740|NCT00978042|B2|Baseline|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
940741|NCT00978042|B1|Baseline|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
940742|NCT00978042|P2|Participant Flow|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
940743|NCT00978042|P1|Participant Flow|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
940744|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
940745|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
940746|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
940747|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
940748|NCT00978042|O2|Outcome|Control Arm_No Treatment Then VOLUMA® XC|No treatment for 6 months, then participants were treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). Participants were eligible for re-treatment if applicable.
940749|NCT00978042|O1|Outcome|VOLUMA® XC Treatment Arm|Participants treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) at study start. Participants were eligible for re-treatment if applicable.
940750|NCT00978042|E2|Reported Event|All Treated Participants_ AEs After Repeat Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs) and who received re-treatment. AEs reported are AEs with onset after retreatment.
940801|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
941168|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
940751|NCT00978042|E1|Reported Event|All Treated Participants_ AEs Initial Treatment|All participants in the original VOLUMA® XC Treatment Arm and all participants in the No Treatment then VOLUMA® XC Arm (who received delayed treatment) treated with JUVÉDERM® VOLUMA® XC Injectable Gel, volume determined by the investigator (up to 12 mLs). AEs reported are AEs with onset prior to retreatment.
940752|NCT00978029|B4|Baseline|Total|Total of all reporting groups
940753|NCT00978029|B3|Baseline|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940754|NCT00978029|B2|Baseline|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940755|NCT00978029|B1|Baseline|Placebo|Matching placebo tablet sublingual, once daily
940756|NCT00978029|P3|Participant Flow|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940757|NCT00978029|P2|Participant Flow|SCH 39641 6 Amb a 1-U|6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily
940758|NCT00978029|P1|Participant Flow|Placebo|Matching placebo tablet sublingual, once daily
940759|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940760|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940761|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
940762|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940763|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940764|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
940765|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940766|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940767|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
940768|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940769|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940770|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
940771|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940772|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940773|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
940774|NCT00978029|O3|Outcome|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940775|NCT00978029|O2|Outcome|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940776|NCT00978029|O1|Outcome|Placebo|Matching placebo tablet sublingual, once daily
940777|NCT00978029|E3|Reported Event|SCH 39641 12 Amb a 1-U|12 Amb a 1-U in an AIT, sublingual, once daily
940778|NCT00978029|E2|Reported Event|SCH 39641 6 Amb a 1-U|6 Amb a 1-U in an AIT, sublingual, once daily
940779|NCT00978029|E1|Reported Event|Placebo|Matching placebo tablet sublingual, once daily
940780|NCT00977938|B5|Baseline|Total|Total of all reporting groups
940781|NCT00977938|B4|Baseline|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940783|NCT00977938|B2|Baseline|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940784|NCT00977938|B1|Baseline|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940785|NCT00977938|P4|Participant Flow|BMS 12-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
940786|NCT00977938|P3|Participant Flow|BMS 30-month DAPT|Of the 2,816 BMS enrolled pts, a total of 1,687 pts underwent randomization at 12 months (845 to 12-month DAPT and 842 to 30-month DAPT).
940787|NCT00977938|P2|Participant Flow|DES 12-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
940788|NCT00977938|P1|Participant Flow|DES 30-month DAPT|Of the 22,866 DES enrolled pts, a total of 9,961 pts underwent randomization at 12 months (4,941 to 12m DAPT and 5,020 to 30m DAPT).
940789|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940790|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940791|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940792|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940793|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940794|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940795|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940796|NCT00977938|O1|Outcome|BMS 30-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940797|NCT00977938|O2|Outcome|BMS 12-month DAPT|Patients who were treated with BMS at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940867|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940802|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940803|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940804|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940805|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940806|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940807|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
940808|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
940809|NCT00977938|O2|Outcome|Propensity-matched BMS|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 2,056 BMS-treated patients were eligible for propensity matching, of whom 1,718 were matched to at least one DES-treated patient (a BMS patient could be matched to up to 8 DES patients; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
940833|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
940834|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
940835|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
940836|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
940837|NCT00977769|O2|Outcome|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
940838|NCT00977769|O1|Outcome|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
940839|NCT00977769|O3|Outcome|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
940810|NCT00977938|O1|Outcome|Propensity-matched DES|Because patients were not randomized to DES or BMS, DES comparisons vs. BMS on stent thrombosis and MACCE were carried out on sample matched on baseline characteristics via propensity score matching. The analyses were restricted to patients enrolled into the 3 contributing studies that planned to follow all enrolled patients (whether or not a patient was randomized) for 33 months. Patients prematurely withdrawing before 29 months follow-up (earliest allowable follow-up time for the 30-month visit) or before experiencing the endpoint were excluded. A total of 13,257 DES-treated patients were eligible for propensity matching, of whom 8,308 patients were matched to BMS-treated patients (up to 8 DES patients could be matched to a BMS patient; i.e., the BMS:DES matching ratio ranged from 1:1 to 1:8).
940811|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940812|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940813|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940814|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940815|NCT00977938|O2|Outcome|DES 12-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 12 months of DAPT
940816|NCT00977938|O1|Outcome|DES 30-month DAPT|Patients who were treated with DES at the index procedure and were randomized at 12 months post procedure to receive a total of 30 months of DAPT
940817|NCT00977938|E4|Reported Event|HCRI DAPT - BMS 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
940818|NCT00977938|E3|Reported Event|HCRI DAPT - BMS 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with BMS at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
940819|NCT00977938|E2|Reported Event|HCRI DAPT - DES 12-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 12 months of DAPT
940820|NCT00977938|E1|Reported Event|HCRI DAPT - DES 30-month DAPT|Patients who were enrolled by HCRI into the HCRI DAPT Study, treated with DES at the index procedure and randomized at 12 months post procedure to receive a total of 30 months of DAPT
940868|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940869|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940870|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940871|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940872|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940873|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940874|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940875|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940821|NCT00977808|B1|Baseline|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
940822|NCT00977808|P1|Participant Flow|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects’ usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
940823|NCT00977808|O2|Outcome|Control: Open-Loop|Insulin dosing was performed by the patient (using their normal routine and personal insulin pump) under a physician's supervision.
940824|NCT00977808|O1|Outcome|Experimental: Closed-Loop Model Predictive Control (MPC)|Insulin dosing was performed by a model-predictive control (MPC) algorithm.
940825|NCT00977808|E1|Reported Event|Adults With Type 1 Diabetes|"During admission 1, open-loop control was used, with the subjects' usual insulin routine and their personal insulin pump.~At the beginning of admission 2 (closed-loop control), one of the two CGM devices was designated as primary, and the closed-loop control algorithm used the data of that system, unless a problem was detected. At 17:00, the model-predictive control (MPC) was initiated in a data-collection mode, automatically receiving CGM data every minute. Administration of the predinner insulin bolus was overseen by the attending physician. MPC, closed-loop control began at 21:30 and continued until 12:00 the next day for a total of 14.5 h. Per FDA restrictions, the algorithm did not automatically control the insulin pump. Instead, the algorithm suggested insulin boluses every 15 min, which, if accepted, were programmed into the insulin pump by the attending physician."
940826|NCT00977769|B4|Baseline|Total|Total of all reporting groups
940827|NCT00977769|B3|Baseline|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
940828|NCT00977769|B2|Baseline|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
940829|NCT00977769|B1|Baseline|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
940842|NCT00977769|E3|Reported Event|Placebo (NaCl)|placebo (NaCl) : Hemodynamic effect of
940843|NCT00977769|E2|Reported Event|Oxytocin 5 u|oxytocin 5 u : Hemodynamic effect of
940844|NCT00977769|E1|Reported Event|Carbetocin 100 µg|carbetocin 100 µg : Hemodynamic effect of
940845|NCT00977704|B1|Baseline|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
940846|NCT00977704|P1|Participant Flow|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
940847|NCT00977704|O1|Outcome|Restylane and Perlane|Single arm safety study of subjects receiving Restylane and Perlane.
940848|NCT00977704|E1|Reported Event|Perlane and Restylane|Perlane and Restylane used open label to correct peri-oral wrinkles
940849|NCT00977665|B3|Baseline|Total|Total of all reporting groups
940850|NCT00977665|B2|Baseline|Placebo|placebo tablet for up to 48 weeks.
940851|NCT00977665|B1|Baseline|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940852|NCT00977665|P2|Participant Flow|Placebo|placebo tablet for up to 48 weeks.
940853|NCT00977665|P1|Participant Flow|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940854|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940855|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940856|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940857|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940858|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940859|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940860|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940861|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940862|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940863|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940864|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940865|NCT00977665|O1|Outcome|Rasagiline Mesylate|rasagiline tablet, 1 mg/day for up to 48 weeks.
940866|NCT00977665|O2|Outcome|Placebo|placebo tablet for up to 48 weeks.
940884|NCT00977613|B1|Baseline|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
940885|NCT00977613|P1|Participant Flow|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
940886|NCT00977613|O1|Outcome|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
940887|NCT00977613|E1|Reported Event|Single Arm, Life Style Counseling|Patients with stage II or III colon or rectal cancer were accrued by physician screening at a visit three to four months following surgical resection. At the time of initial subject study enrollment, and at each follow-up visit, the physician or nurse administering the questionnaire was to review the benefit of adjuvant exercise and encourage patients to continue or increase their weekly activity in order to maintain at least 18 MET/week.
940888|NCT00977561|B3|Baseline|Total|Total of all reporting groups
940889|NCT00977561|B2|Baseline|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940890|NCT00977561|B1|Baseline|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Day 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940891|NCT00977561|P2|Participant Flow|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940892|NCT00977561|P1|Participant Flow|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 milligram/kilogram (mg/kg) administered intravenously (IV) over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 milligram/square meter (mg/m^2) IV over 1 hour or carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 5 milligram/milliliter*minute (mg/mL*min) IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940893|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940926|NCT00977470|B2|Baseline|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940894|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940895|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940896|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940897|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940898|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940899|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940900|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940901|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940902|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940903|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Participants who received figitumumab, whether figitumumab (20 mg/kg, IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles) was given in combination with cisplatin (75 mg/m^2 IV over 1 hour on Day 1 of each cycle) or carboplatin (AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 of each cycle) followed by etoposide (100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle) from the beginning or figitumumab was given as a single agent after documented disease progression with cisplatin (or carboplatin) and etoposide. When given as a single agent, figitumumab was administered as IV infusion on Days 1 and 2 of the initial cycle and on Day 1 of subsequent cycles, up to 17 cycles in the absence of further disease progression or intolerable toxicity. Each cycle was 21 days cycle.
940904|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940905|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940906|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940927|NCT00977470|B1|Baseline|Erlotinib|Erlotinib: 150 mg taken orally once daily
940928|NCT00977470|P2|Participant Flow|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940929|NCT00977470|P1|Participant Flow|Erlotinib|Erlotinib: 150 mg taken orally once daily
951441|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
940907|NCT00977561|O1|Outcome|Figitumumab+ Cisplatin (or Carboplatin) + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940908|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940909|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940910|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940911|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940912|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
941010|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
940913|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940914|NCT00977561|O2|Outcome|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940915|NCT00977561|O1|Outcome|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940916|NCT00977561|E2|Reported Event|Cisplatin or Carboplatin + Etoposide|Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940917|NCT00977561|E1|Reported Event|Figitumumab + Cisplatin or Carboplatin + Etoposide|Figitumumab 20 mg/kg administered IV over 1 hour on Day 2 of Cycle 1 and on Day 1 of subsequent cycles (up to 17 cycles in the absence of further disease progression or intolerable toxicity). Cisplatin 75 mg/m^2 IV over 1 hour or carboplatin at a dose to attain the target AUC of 5 mg/mL*min IV over 15-60 minutes on Day 1 (up to 6 cycles) followed by etoposide 100 mg/m^2 IV over 1 hour on Days 1, 2 and 3 of each cycle (up to 6 cycles or until progression or intolerable toxicity). Each cycle was 21 days cycle.
940918|NCT00977548|B1|Baseline|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
940919|NCT00977548|P1|Participant Flow|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
940920|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
940921|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
940922|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
940923|NCT00977548|O1|Outcome|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
940924|NCT00977548|E1|Reported Event|Erlotinib Treatment|Erlotinib was given as an oral 150 mg daily dose for 16 weeks. The dose was adjusted for diarrhea, rash and pulmonary toxicity.
940925|NCT00977470|B3|Baseline|Total|Total of all reporting groups
941028|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
940930|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940931|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
940932|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940933|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
940934|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940935|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
940936|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940937|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
940938|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940939|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
940940|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940941|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
940942|NCT00977470|O2|Outcome|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940943|NCT00977470|O1|Outcome|Erlotinib|Erlotinib: 150 mg taken orally once daily
940944|NCT00977470|E2|Reported Event|Erlotinib and Hydroxychloroquine|"Erlotinib: 150 mg taken orally once daily~Hydroxychloroquine: 1000 mg taken orally once daily after erlotinib"
940945|NCT00977470|E1|Reported Event|Erlotinib|Erlotinib: 150 mg taken orally once daily
940946|NCT00977379|B3|Baseline|Total|Total of all reporting groups
940988|NCT00977314|O1|Outcome|Global Benefit|The Global Benefit APHAB at 30 days is the change in APHAB scores between the unaided score at the start of the study and the APHAB score after 30 days of therapy. The APHAB questionnaire produces an overall Global score (GBL). The benefit provided by the SoundBite System can be determined by comparing changes in the mean APHAB score. The larger the APHAB benefit score the great the benefit. A negative APHAB score represents therapy resulting in a worse outcome than no therapy.
940947|NCT00977379|B2|Baseline|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940948|NCT00977379|B1|Baseline|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940949|NCT00977379|P2|Participant Flow|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 milligrams per square meter (mg/m^2) orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940950|NCT00977379|P1|Participant Flow|WBRT Followed by Standard of Care|Participants received 3000 centi-Gray (cGy) whole brain radiation therapy (WBRT) in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (central nervous system [CNS] or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940951|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940952|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940953|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940954|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940955|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940956|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940957|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940958|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940959|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
951310|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
940960|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940961|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940962|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940963|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940964|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940965|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940966|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940967|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
941029|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
940968|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940969|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940970|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940971|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940972|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
941011|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941169|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
940973|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940974|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940975|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940976|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940977|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940978|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940979|NCT00977379|O2|Outcome|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940980|NCT00977379|O1|Outcome|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940981|NCT00977379|E2|Reported Event|WBRT+Capecitabine Followed by Capecitabine Maintenance|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) concurrent with capecitabine 825 mg/m^2 orally twice daily, Days 1-14 of a 21 day cycle for 1 cycle followed by capecitabine 1000 mg/m^2 orally twice daily Days 1-14 every 21 days starting with Cycle 2, one week after completion of WBRT and continuing until the halting of capecitabine for any reason (CNS or extra-cranial progression, unacceptable toxicity, withdrawal of participant consent or death).
940982|NCT00977379|E1|Reported Event|WBRT Followed by Standard of Care|Participants received 3000 cGy WBRT in 10 single daily fractions over 12 to 14 days (300 cGy / fraction) followed by standard of care therapy at the discretion of the treating oncologist starting no earlier than 2 weeks after completion of WBRT. The participants were followed during the treatment until the halting of standard of care for any reason (CNS or extra-cranial tumor progression, unacceptable toxicity, change of therapeutic strategy, withdrawal of participant consent, or death).
940983|NCT00977314|B3|Baseline|Total|Total of all reporting groups
940984|NCT00977314|B2|Baseline|Pilot Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
940985|NCT00977314|B1|Baseline|Analyzed Group|A total of thirty-five (35) subjects were enrolled in this study. Per the protocol, the first five (5) subjects enrolled were the pilot phase of the study to work out the process flow and training of the centers and participants. The data obtained from the first five subjects were excluded from all analyses. With an approximated 20% subject dropout rate anticipated, 30 subjects were enrolled in the study with only 24 subjects expected to complete it.
940986|NCT00977314|P2|Participant Flow|Pilot Group|"Per the protocol, the first five (5) subjects were enrolled in the pilot group of the study to work out the process flow and training of the centers and participants."
940987|NCT00977314|P1|Participant Flow|Analyzed Group|30 subjects were enrolled in the analyzed group with only 24 subjects expected to complete it. With an approximated 20% subject dropout rate anticipated. The total number of subjects that completed the study was 28 of 30 enrolled in the analyzed group.
941054|NCT00977171|O1|Outcome|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
941170|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
940989|NCT00977314|O1|Outcome|HINT (dB) Advantage|"Effectiveness was defined as “Change from Baseline” analysis of the Hearing in Noise Test (HINT), Noise on Better Side Scores between without the BCD at day one and with the BCD at day thirty.Effectiveness was determined as an improvement in the HINT score for which the device was designed, that is, the condition where noise originates on the normal hearing side and speech is presented from the front. .~An improvement in HINT score is indicated as a negative (-) dB value change. A change in the HINT score of -1 dB represents an improvement of 10% in speech intelligibility in that particular test condition. A 10% improvement in speech intelligibility in this very adverse listening condition is a noticeable benefit to the SSD subject. This amount of improvement is even more of a benefit in more realistic, less adverse listening conditions."
940990|NCT00977314|O1|Outcome|Medical, Dental, Audiological Safety 30 Days|"The safety parameters for the trial were monitored throughout the Evaluation Phase (30 days). The safety checks included:~Comprehensive Medical evaluation at Enrollment and at Termination~Comprehensive Dental evaluation at Enrollment and at Termination, with interim dental checks at each visit in between, if needed~Comprehensive Audiological evaluation at Enrollment and Termination.~No Medical, Dental or Audiological adverse events."
940991|NCT00977314|E1|Reported Event|Incidence of Device- and Procedure-related Adverse Events|Incidence of device- and procedure-related adverse events at 30 days
940992|NCT00977197|B3|Baseline|Total|Total of all reporting groups
940993|NCT00977197|B2|Baseline|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
940994|NCT00977197|B1|Baseline|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
940995|NCT00977197|P2|Participant Flow|Placebo|"Subjects randomized to this arm will receive placebo matching the study drug.~Placebo: A matching placebo will be administered twice a day"
940996|NCT00977197|P1|Participant Flow|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study.~Pregabalin: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
940997|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
940998|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
940999|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941030|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
941031|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
941032|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
941000|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941001|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941002|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941003|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941004|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941005|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941006|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941007|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941008|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941009|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941055|NCT00977171|E1|Reported Event|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
941056|NCT00977106|B3|Baseline|Total|Total of all reporting groups
941012|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941013|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941014|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941015|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941016|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941017|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941018|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941019|NCT00977197|O2|Outcome|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941020|NCT00977197|O1|Outcome|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941021|NCT00977197|E2|Reported Event|Placebo|Subjects randomized to this arm will receive placebo matching the study drug.
941022|NCT00977197|E1|Reported Event|Pregabalin|"Subjects randomized to this arm will receive the following dosage:~75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study."
941023|NCT00977184|B3|Baseline|Total|Total of all reporting groups
941024|NCT00977184|B2|Baseline|Sham rTMS|Subjects receiving sham rTMS.
941025|NCT00977184|B1|Baseline|Real rTMS|Subjects receiving real rTMS
941026|NCT00977184|P2|Participant Flow|Sham rTMS|Subjects receiving sham rTMS.
941027|NCT00977184|P1|Participant Flow|Real rTMS|Subjects receiving real rTMS
941033|NCT00977184|O3|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
941034|NCT00977184|O2|Outcome|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
941035|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
941036|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
941037|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
941038|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
941039|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
941040|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
941041|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
941042|NCT00977184|O2|Outcome|On Medictation Sham rTMS|Subjects ON medication while receiving SHAM rTMS
941043|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
941044|NCT00977184|O4|Outcome|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
941045|NCT00977184|O3|Outcome|Off Medication Real rTMS|Subjects OFF medication while receiving REAL rTMS
941046|NCT00977184|O2|Outcome|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
941047|NCT00977184|O1|Outcome|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
941048|NCT00977184|E4|Reported Event|Off Medication Sham rTMS|Subjects OFF medication while receiving SHAM rTMS
941049|NCT00977184|E3|Reported Event|On Medication Sham rTMS|Subjects ON medication while receiving SHAM rTMS
941050|NCT00977184|E2|Reported Event|Off Medictation Real rTMS|Subjects OFF medication while receiving REAL rTMS
941051|NCT00977184|E1|Reported Event|On Medication Real rTMS|Subjects ON medication while receiving REAL rTMS
941052|NCT00977171|B1|Baseline|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
941053|NCT00977171|P1|Participant Flow|Droxidopa|Droxidopa: Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes up to a 2 week titration period followed by a 12 week treatment period
941057|NCT00977106|B2|Baseline|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941058|NCT00977106|B1|Baseline|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941059|NCT00977106|P2|Participant Flow|Tocilizumab|Participants received tocilizumab IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941060|NCT00977106|P1|Participant Flow|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) intravenously (IV) during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 milligrams per kilogram (mg/kg; 800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941061|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941062|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941063|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941064|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941065|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941066|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941067|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941068|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941069|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941070|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941137|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941243|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941071|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941072|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941073|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941074|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941075|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941076|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941077|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941078|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941079|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941152|NCT00977080|P4|Participant Flow|Cinacalcet in the Oral Stratum|Oral stratum
941080|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941081|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941082|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941083|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941084|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941085|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941086|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941087|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941088|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941089|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941090|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941091|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941092|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941093|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941094|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941095|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941096|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941097|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941098|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941099|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941100|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941101|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941153|NCT00977080|P3|Participant Flow|Oral Paricalcitol in the Oral Stratum|Oral stratum
941154|NCT00977080|P2|Participant Flow|Cinacalcet in the IV Stratum|IV stratum
941102|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941103|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941104|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941105|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941106|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941107|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941108|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941109|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941110|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941111|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941112|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941113|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941194|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941114|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941115|NCT00977106|O1|Outcome|Placebo, Tocilzumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941116|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941117|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941118|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941119|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941120|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941121|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941122|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941123|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941155|NCT00977080|P1|Participant Flow|IV Paricalcitol in the IV Stratum|IV stratum
941124|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941125|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941126|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received either tocilizumab 8 mg/kg (800 mg maximum) IV or placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4 (Open Treatment Period), all participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941127|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941128|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941129|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941130|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941131|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941132|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941133|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941134|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941135|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941136|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941138|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941139|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941140|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941141|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941142|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941143|NCT00977106|O2|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941144|NCT00977106|O1|Outcome|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941145|NCT00977106|E2|Reported Event|Placebo, Tocilizumab|Participants received placebo solution (containing polysorbate 80, sucrose, and water for injection) IV during the Double-Blind Treatment Period on Day 0. Starting at Week 4, participants received tocilizumab 8 mg/kg (800 mg maximum) IV, once every 4 weeks up to 11 months (up to Week 44), for a maximum of 11 infusions.
941146|NCT00977106|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg (800 mg maximum) IV once every 4 weeks up to 12 months (up to Week 44), for a maximum of 12 infusions.
941147|NCT00977080|B5|Baseline|Total|Total of all reporting groups
941148|NCT00977080|B4|Baseline|Cinacalcet in the Oral Stratum|Oral stratum
941149|NCT00977080|B3|Baseline|Oral Paricalcitol in the Oral Stratum|Oral stratum
941150|NCT00977080|B2|Baseline|Cinacalcet in the IV Stratum|IV stratum
941151|NCT00977080|B1|Baseline|IV Paricalcitol in the IV Stratum|IV stratum
941173|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
941174|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
941175|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
941176|NCT00977080|O4|Outcome|Cinacalcet in the Oral Stratum|Oral stratum
941177|NCT00977080|O3|Outcome|Oral Paricalcitol in the Oral Stratum|Oral stratum
941178|NCT00977080|O2|Outcome|Cinacalcet in the IV Stratum|IV stratum
941179|NCT00977080|O1|Outcome|IV Paricalcitol in the IV Stratum|IV stratum
941180|NCT00977080|E4|Reported Event|Cinacalcet in the Oral Stratum|Oral stratum
941181|NCT00977080|E3|Reported Event|Oral Paricalcitol in the Oral Stratum|Oral stratum
941182|NCT00977080|E2|Reported Event|Cinacalcet in the IV Stratum|IV stratum
941183|NCT00977080|E1|Reported Event|IV Paricalcitol in the IV Stratum|IV stratum
941184|NCT00976989|B4|Baseline|Total|Total of all reporting groups
941185|NCT00976989|B3|Baseline|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941186|NCT00976989|B2|Baseline|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941187|NCT00976989|B1|Baseline|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941188|NCT00976989|P3|Participant Flow|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941189|NCT00976989|P2|Participant Flow|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941190|NCT00976989|P1|Participant Flow|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941191|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941192|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941193|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
942615|NCT00973765|E1|Reported Event|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
941195|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941196|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941197|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941198|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941199|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941200|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941201|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941202|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941264|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941783|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
941203|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941204|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941205|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941206|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941207|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941208|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941209|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941210|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941211|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941212|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941213|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941214|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941215|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941242|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941216|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941217|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941218|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941219|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941220|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941221|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941222|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941223|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941224|NCT00976989|O3|Outcome|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
942022|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
941225|NCT00976989|O2|Outcome|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941226|NCT00976989|O1|Outcome|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941227|NCT00976989|E3|Reported Event|T+P Concomitant Non-Anthracycline Chemotherapy|Trastuzumab, carboplatin, docetaxel (TCH) and pertuzumab every three weeks, for six cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941228|NCT00976989|E2|Reported Event|T+P Sequential Anthracycline-based Chemotherapy|FEC every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 21 as adjuvant therapy post-surgery.
941229|NCT00976989|E1|Reported Event|T+P Concomitant Anthracycline-based Chemotherapy|5-Fluorouracil, epirubicin with cyclophosphamide (FEC), trastuzumab and pertuzumab every three weeks for three cycles, followed by docetaxel, trastuzumab and pertuzumab every three weeks, for three cycles as neoadjuvant therapy. Trastuzumab every three weeks from Cycle 7 up to Cycle 17 as adjuvant therapy post-surgery.
941230|NCT00976950|B1|Baseline|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
941231|NCT00976950|P1|Participant Flow|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
941232|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
941233|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
941234|NCT00976950|O1|Outcome|Aptivus and Ritonavir|TPV/r means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
941235|NCT00976950|E1|Reported Event|Aptivus and Ritonavir|ARV means Treated with Tipranavir (Aptivus) 500mg twice daily and low-dose ritonavir
941236|NCT00976937|B3|Baseline|Total|Total of all reporting groups
941237|NCT00976937|B2|Baseline|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
941238|NCT00976937|B1|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 mg capsule orally QD up to Week 24.
941239|NCT00976937|P2|Participant Flow|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo: sitagliptin 100 mg capsule orally QD up to Week 24 along with volume matching lixisenatide placebo 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
941240|NCT00976937|P1|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo: lixisenatide 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24 along with placebo matching to sitagliptin 100 milligram (mg) capsule orally QD up to Week 24.
941241|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941244|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941245|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941246|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941247|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941248|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941249|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941250|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941251|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941252|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941253|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941254|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941255|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941256|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941257|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941258|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941259|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941260|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941261|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941262|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941263|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941265|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941266|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941267|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941268|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941269|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941270|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941271|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941272|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941273|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941274|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941275|NCT00976937|O2|Outcome|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941276|NCT00976937|O1|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941277|NCT00976937|E2|Reported Event|Sitagliptin|Sitagliptin along with 2-step initiation regimen of volume matching lixisenatide placebo.
941278|NCT00976937|E1|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide along with sitagliptin placebo.
941279|NCT00976911|B3|Baseline|Total|Total of all reporting groups
941280|NCT00976911|B2|Baseline|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941281|NCT00976911|B1|Baseline|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941282|NCT00976911|P2|Participant Flow|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion. Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 milligrams per kilogram (mg/kg) IV every 2 weeks (q2w; or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
951442|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
941283|NCT00976911|P1|Participant Flow|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 milligrams per square meter (mg/m^2) as a 1-hour intravenous (IV) infusion on Days 1, 8, 15, and 22 every 4 weeks (q4w) OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 every 3 weeks [q3w]) OR pegylated liposomal doxorubicin (PLD) 40 mg/m^2 as a 1 milligram per minute (mg/min) infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941284|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941285|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941318|NCT00976703|B1|Baseline|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
941375|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941376|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941286|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941287|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941288|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941289|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941290|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941291|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
942646|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
941292|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941293|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941294|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941295|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941296|NCT00976911|O2|Outcome|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941297|NCT00976911|O1|Outcome|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941298|NCT00976911|E2|Reported Event|Chemotherapy + Bevacizumab|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices. The chosen chemotherapy was combined with bevacizumab 10 mg/kg IV q2w (or bevacizumab 15 mg/kg q3w if used in combination with topotecan 1.25 mg/m^2 on Days 1-5 on a q3w schedule). The initial bevacizumab infusion was over 90 minutes, with subsequent infusions over 60 minutes and then 30 minutes, as tolerated.
941299|NCT00976911|E1|Reported Event|Chemotherapy|Participants received one of the following chemotherapies at the discretion of the investigator: paclitaxel, 80 mg/m^2 as a 1-hour IV infusion on Days 1, 8, 15, and 22 q4w OR topotecan 4 mg/m^2 as a 30-minute IV infusion on Days 1, 8, and 15 q4w (alternatively, a 1.25 mg/m^2 dose could have been administered over 30 minutes on Days 1-5 q3w) OR PLD 40 mg/m^2 as a 1 mg/min infusion on Day 1 q4w (after Cycle 1 the drug could have been administered as a 1 hour infusion). Depending on chosen chemotherapy, pre-medication was implemented according to local practices.
941300|NCT00976716|B1|Baseline|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941301|NCT00976716|P1|Participant Flow|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID (twice daily) for up to 7 days from Day 2.
941302|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941303|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941304|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
941305|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
942647|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
941306|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941307|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941308|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941309|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
941310|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941311|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2
941312|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941313|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941314|NCT00976716|O1|Outcome|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941315|NCT00976716|E1|Reported Event|Celecoxib|Received the first dose of celecoxib 400 mg and the second dose of celecoxib 200 mg at least 6 hours apart on Day 1, followed by celecoxib 200 mg BID for up to 7 days from Day 2.
941316|NCT00976703|B3|Baseline|Total|Total of all reporting groups
941317|NCT00976703|B2|Baseline|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
941373|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941374|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941319|NCT00976703|P2|Participant Flow|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
941320|NCT00976703|P1|Participant Flow|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
941321|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
941322|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
941323|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
941324|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
941325|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
941326|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
941327|NCT00976703|O2|Outcome|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
941328|NCT00976703|O1|Outcome|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
941329|NCT00976703|E2|Reported Event|Leg Taping (Taping)|For the leg taping, the cervical foley catheter will be pulled to gentle traction and attached to the patient's inner thigh using a reclosable foley catheter fastener. The foley catheter and the traction will be assessed every 30min by the nursing staff. The tension will be renewed and the Foley re-adjusted if necessary at each check.
951443|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
941330|NCT00976703|E1|Reported Event|Weighted Bag (Traction)|For the weighted bag, a 500cc saline bag will be taped to an empty Foley bag which will be attached to the cervical Foley catheter. This bag will then be placed to gravity over the end of the bed. The bed will be raised so that the bag does not touch the floor. The foley and the bag will be re-assessed every 30min by the nursing staff.
941331|NCT00976677|B3|Baseline|Total|Total of all reporting groups
941332|NCT00976677|B2|Baseline|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941333|NCT00976677|B1|Baseline|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941334|NCT00976677|P2|Participant Flow|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941335|NCT00976677|P1|Participant Flow|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941336|NCT00976677|O2|Outcome|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941337|NCT00976677|O1|Outcome|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941338|NCT00976677|E2|Reported Event|Arm B|Patients receive paclitaxel and carboplatin (with or without bevacizumab) as in arm A. Patients also receive oral erlotinib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive erlotinib hydrochloride (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941339|NCT00976677|E1|Reported Event|Arm A|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes (with or without bevacizumab IV over 30-90 minutes) on day 1. Patients also receive an oral placebo once daily on days 1-21. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses, patients with stable or responding disease may continue to receive placebo (with or without bevacizumab) as above in the absence of disease progression or unacceptable toxicity.
941340|NCT00976664|B3|Baseline|Total|Total of all reporting groups
941341|NCT00976664|B2|Baseline|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
941342|NCT00976664|B1|Baseline|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
941343|NCT00976664|P2|Participant Flow|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
941344|NCT00976664|P1|Participant Flow|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
941345|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
941346|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
941347|NCT00976664|O2|Outcome|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
941348|NCT00976664|O1|Outcome|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
941349|NCT00976664|E2|Reported Event|Wait Group|This group received NO orthotics at the randomization group, as they were randomized to the wait-control group. Orthotics were given to these subjects at week 6. Various outcome measures were collected during the 12 weeks.
941350|NCT00976664|E1|Reported Event|Orthotic Group|This group received orthotics at randomization visit. Various outcome measures were collected over 12 weeks.
941351|NCT00976599|B3|Baseline|Total|Total of all reporting groups
941352|NCT00976599|B2|Baseline|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
942648|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
941353|NCT00976599|B1|Baseline|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941354|NCT00976599|P2|Participant Flow|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941355|NCT00976599|P1|Participant Flow|CP-690,550|CP-690,550 10 milligram (mg) tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941356|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941357|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941358|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941359|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941360|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941361|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941362|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941363|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941364|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941365|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941366|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941367|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941368|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941369|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941370|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941371|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941372|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
942023|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
941377|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941378|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941379|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941380|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941381|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941382|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941383|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941384|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941385|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941386|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941387|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941388|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941389|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941390|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941391|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941392|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941393|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941394|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941395|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941396|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941397|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941398|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941399|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941400|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941401|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941402|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
951444|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
941403|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941404|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941405|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941406|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941407|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941408|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941409|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941410|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941411|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941412|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941413|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941414|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941415|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941416|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941417|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941418|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941419|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941420|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941421|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941422|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941423|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941424|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941425|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941426|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941427|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941428|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941429|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941430|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941431|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941432|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941433|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941434|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941435|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941436|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941437|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941438|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941439|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941440|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941441|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941442|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941443|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941444|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941445|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941446|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941447|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941448|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941449|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941450|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941451|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941452|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941453|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941454|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941455|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941456|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941457|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941458|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941459|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941460|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941461|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941462|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941463|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941464|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941465|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941466|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941467|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941468|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941469|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941470|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941471|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941472|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941473|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941474|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941475|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941476|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941477|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941478|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941479|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941480|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941481|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941482|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941483|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941484|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941485|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941486|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941487|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941488|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941489|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941490|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941491|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941492|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941493|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941494|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941495|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941496|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941497|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941498|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941499|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941500|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941501|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941502|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941503|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941504|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941505|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941506|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941507|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941508|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941509|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941510|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941511|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941512|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941513|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941514|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941515|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941516|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941517|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941518|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941519|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941520|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941521|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941522|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941523|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941524|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941525|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941526|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941527|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941528|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941529|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941530|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941531|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941532|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941533|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941534|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941535|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941536|NCT00976599|O2|Outcome|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941537|NCT00976599|O1|Outcome|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941538|NCT00976599|E2|Reported Event|Placebo|Placebo matched to CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941539|NCT00976599|E1|Reported Event|CP-690,550|CP-690,550 10 mg tablet orally twice daily up to Day 27 followed by single oral dose on Day 28.
941540|NCT00976573|B3|Baseline|Total|Total of all reporting groups
941541|NCT00976573|B2|Baseline|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941758|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941542|NCT00976573|B1|Baseline|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941543|NCT00976573|P2|Participant Flow|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941544|NCT00976573|P1|Participant Flow|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941545|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941546|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941547|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941548|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941549|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941550|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941572|NCT00976521|E2|Reported Event|Local Infusion, No Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.
941784|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
941551|NCT00976573|O2|Outcome|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941552|NCT00976573|O1|Outcome|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941553|NCT00976573|E2|Reported Event|Arm B (Bevacizumab, Paclitaxel, Carboplatin, and Everolimus)|Patients receive bevacizumab, paclitaxel, and carboplatin as in Arm I. Patients also receive 5 mg everolimus PO QD three times weekly (e.g. Monday, Wednesday, Friday). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941554|NCT00976573|E1|Reported Event|Arm A (Bevacizumab, Paclitaxel, and Carboplatin)|Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1 and 15, 80 mg/m^2 paclitaxel IV over 60 minutes on days 1, 8, and 15, and AUC 5 carboplatin IV over 30 minutes on day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
941555|NCT00976521|B5|Baseline|Total|Total of all reporting groups
941556|NCT00976521|B4|Baseline|No Local Infusion, no Aspiration|No local infusion of abciximab and no thrombus aspiration
941557|NCT00976521|B3|Baseline|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
941558|NCT00976521|B2|Baseline|Local Infusion, no Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration
941559|NCT00976521|B1|Baseline|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.
941560|NCT00976521|P4|Participant Flow|No Local Infusion, no Aspiration|"No local infusion of abciximab and no thrombus aspiration.~The lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care."
941561|NCT00976521|P3|Participant Flow|No Local Infusion, Thrombus Aspiration|"No local infusion of abciximab, thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed."
941562|NCT00976521|P2|Participant Flow|Local Infusion, no Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter and no thrombus aspiration.~The initial device used to cross the lesion is a 1.0 mm or 1.5 mm diameter ClearWay™ RX Infusion Catheter (1.0 mm for complete occlusion).~If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
941581|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941563|NCT00976521|P1|Participant Flow|Local Infusion, Thrombus Aspiration|"Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration.~A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until the operator appreciates that no further thrombus is being removed.~After withdrawing the aspiration catheter, the lesion is crossed with a 1.0 mm, 1.5 mm, or 2.0 mm diameter ClearWay™ RX Infusion Catheter (depending on the lumen diameter created by thrombus aspiration and the reference vessel diameter). If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter."
941564|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
941565|NCT00976521|O2|Outcome|No Aspiration|No aspiration includes subjects randomized to either the following two arms: abciximab infusion arm without aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion without aspiration, the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, infused at a rate of 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter. If randomized to no abciximab without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
941566|NCT00976521|O1|Outcome|Thrombus Aspiration|Thrombus aspiration includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or no abciximab infusion with aspiration. A 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter. Multiple passes should be made with contrast injection after each pass until the operator appreciates that no further thrombus is being removed.
941567|NCT00976521|O3|Outcome|Combined|Combined includes subjects randomized to all four arms.
941568|NCT00976521|O2|Outcome|No Infusion|No Infusion includes subjects randomized to either the following two arms: no abciximab infusion with aspiration or no abciximab infusion without aspiration. If randomized to abciximab infusion with aspiration, a 6 French Export® Aspiration Catheter is passed across the target coronary segment during continuous aspiration. Several passes should be made across the lesion to attempt to remove residual thrombus, always with continuous aspiration when advancing or withdrawing the catheter until no further thrombus is being removed. If randomized to no abciximab infusion without aspiration, the lesion is pre-dilated with at least a 2.0 mm angioplasty balloon and then stent implantation is performed as per standard of care.
941569|NCT00976521|O1|Outcome|Abciximab Infusion|Abciximab Infusion includes subjects randomized to either the following two arms: abciximab active infusion arm with aspiration or abciximab infusion arm without aspiration. If the lesion is successfully crossed or penetrated by at least 1 mm, an intracoronary bolus of abciximab (0.25 mg/kg body weight, given as 10 cc over approximately 60 seconds) is infused through the ClearWay™ RX Infusion Catheter.
941570|NCT00976521|E4|Reported Event|No Local Infusion, No Aspiration|No local infusion of abciximab and no thrombus aspiration.
941571|NCT00976521|E3|Reported Event|No Local Infusion, Thrombus Aspiration|No local infusion of abciximab, thrombus aspiration.
941785|NCT00975780|O2|Outcome|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
941573|NCT00976521|E1|Reported Event|Local Infusion, Thrombus Aspiration|Local infusion of abciximab using the ClearWay™ RX Infusion Catheter following thrombus aspiration
941574|NCT00976508|B3|Baseline|Total|Total of all reporting groups
941575|NCT00976508|B2|Baseline|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941576|NCT00976508|B1|Baseline|Figitumumab 20 mg/kg +Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941577|NCT00976508|P2|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941578|NCT00976508|P1|Participant Flow|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941579|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941580|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941632|NCT00976482|E1|Reported Event|Pacemaker|implanted Patients
941633|NCT00976456|B3|Baseline|Total|Total of all reporting groups
941865|NCT00975585|E1|Reported Event|Senofilcon A|contact lens
941582|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941583|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941584|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941585|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941586|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941587|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941588|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941589|NCT00976508|O2|Outcome|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
941650|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
941590|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941591|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941592|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941593|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941594|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941595|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941596|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941755|NCT00975806|P3|Participant Flow|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941866|NCT00975507|B3|Baseline|Total|Total of all reporting groups
941597|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941598|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941599|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941600|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941601|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941602|NCT00976508|O1|Outcome|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941603|NCT00976508|O2|Outcome|Figitumumab 20mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941604|NCT00976508|O1|Outcome|Figitumumab 20mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily, up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941605|NCT00976508|E2|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 20 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles (up to total duration of 27 cycles). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 20 mg subcutaneously once daily up to total duration of 27 cycles. Each cycle was of 21 days.
941606|NCT00976508|E1|Reported Event|Figitumumab 20 mg/kg + Pegvisomant 10 mg|Figitumumab 20 milligram/kilogram (mg/kg) intravenously over 1 to 2.5 hours on Day 1 and 2 of Cycle 1 and on Day 1 of subsequent cycles, up to a maximum of 17 cycles (corresponding to 1 year). Pegvisomant 40 mg subcutaneously on Day 15 of Cycle 1 or Day 1 of Cycle 2 and thereafter pegvisomant 10 mg subcutaneously once daily up to a maximum of 17 cycles (corresponding to 1 year). Each cycle was of 21 days.
941607|NCT00976495|B4|Baseline|Total|Total of all reporting groups
941608|NCT00976495|B3|Baseline|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
941609|NCT00976495|B2|Baseline|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
941610|NCT00976495|B1|Baseline|Placebo|Tablet, oral, once daily for 12 weeks
941611|NCT00976495|P3|Participant Flow|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
941612|NCT00976495|P2|Participant Flow|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
941613|NCT00976495|P1|Participant Flow|Placebo|Tablet, oral, once daily for 12 weeks
941614|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
941615|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
941616|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
941617|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
941618|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
941619|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
941620|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
941621|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
941622|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
941623|NCT00976495|O3|Outcome|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
941624|NCT00976495|O2|Outcome|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
941625|NCT00976495|O1|Outcome|Placebo|Tablet, oral, once daily for 12 weeks
941626|NCT00976495|E3|Reported Event|Hydrochlorothiazide 25 mg|Tablet, oral, once daily for 12 weeks
941627|NCT00976495|E2|Reported Event|Dapagliflozin 10 mg|Tablet, oral, once daily for 12 weeks
941628|NCT00976495|E1|Reported Event|Placebo|Tablet, oral, once daily for 12 weeks
941629|NCT00976482|B1|Baseline|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
941630|NCT00976482|P1|Participant Flow|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
941631|NCT00976482|O1|Outcome|Pacemaker|Patients currently implanted with permanent Pacemaker according to guidelines
941634|NCT00976456|B2|Baseline|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
941635|NCT00976456|B1|Baseline|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
941636|NCT00976456|P2|Participant Flow|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
941637|NCT00976456|P1|Participant Flow|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
941638|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
941639|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
941640|NCT00976456|O2|Outcome|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
941641|NCT00976456|O1|Outcome|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
941642|NCT00976456|E2|Reported Event|Bevacizumab + Pemetrexed + Carboplatin|"Bevacizumab + Pemetrexed + Carboplatin~Bevacizumab + Pemetrexed + Carboplatin: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes and carboplatin AUC 5 on D1 every 3 weeks"
941643|NCT00976456|E1|Reported Event|Bevacizumab + Pemetrexed|"Bevacizumab + Pemetrexed~Bevacizumab + Pemetrexed: Bevacizumab 7,5 mg/kg i.v. over 60 min every 3 weeks plus pemetrexed 500 mg/m2 i.v. on D1 over 10 minutes every 3 weeks"
941644|NCT00976404|B3|Baseline|Total|Total of all reporting groups
941645|NCT00976404|B2|Baseline|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941646|NCT00976404|B1|Baseline|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
941647|NCT00976404|P2|Participant Flow|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941648|NCT00976404|P1|Participant Flow|ART Intensification: Maraviroc + Raltegravir|ART Intensification (addition of raltegravir and maraviroc) to suppressive ART for 56 weeks
941649|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941651|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941652|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
941653|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941654|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
941655|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941656|NCT00976404|O1|Outcome|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
941657|NCT00976404|O2|Outcome|Maraviroc + Raltegravir Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941658|NCT00976404|O1|Outcome|ART Intensification: Maraviroc +Raltegravir|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
941659|NCT00976404|E2|Reported Event|Maraviroc + Raltegravir Intens. Plus DNA + HIV-rAd5 Vaccine|ART Intensification (addition of raltegravir and maraviroc for 56 weeks) PLUS immunomodulation therapy with DNA prime vaccine (Weeks 8,12,16) + HIV-recombinant Ad5-based vaccine (Week 32)
941660|NCT00976404|E1|Reported Event|Maraviroc + Raltegravir Intensification|ART Intensification (addition of raltegravir and maraviroc to suppressive ART for 56 weeks)
941661|NCT00976391|B3|Baseline|Total|Total of all reporting groups
941662|NCT00976391|B2|Baseline|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941663|NCT00976391|B1|Baseline|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941756|NCT00975806|P2|Participant Flow|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
942649|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
941664|NCT00976391|P2|Participant Flow|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941665|NCT00976391|P1|Participant Flow|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941666|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941667|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941668|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941669|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941670|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941671|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941672|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941673|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941674|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941738|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
941675|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941676|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941677|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941678|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941679|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941680|NCT00976391|O2|Outcome|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
941681|NCT00976391|O1|Outcome|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941682|NCT00976391|E2|Reported Event|Preprandial Lispro Insulin With Insulin Glargine|Participants received a combination of insulin glargine (with uptitration if needed) and preprandial lispro insulin (with uptitration as appropriate) as prescribed by their physician.Participants did not receive investigational product during the Follow-up Period.
942408|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
941683|NCT00976391|E1|Reported Event|Albiglutide 30 mg With Insulin Glargine|Participants received albiglutide 30 mg as a subcutaneous injection weekly (with uptitration to 50 mg weekly if needed) via a fully disposable pen injector system combined with insulin glargine (with uptitration if needed) as prescribed by their physician. Participants did not receive investigational product during the Follow-up Period.
941684|NCT00976339|B1|Baseline|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year
941685|NCT00976339|P1|Participant Flow|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU weekly, for 1 year
941686|NCT00976339|O1|Outcome|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU or 30,000 IU weekly for 1 year
941687|NCT00976339|E1|Reported Event|Combined Data: Cholecalciferol 20,000 IU and 30,000 IU Groups|Subjects received Cholecalciferol 20,000 IU weekly or 30,000 IU for 1 year
941688|NCT00976274|B3|Baseline|Total|Total of all reporting groups
941689|NCT00976274|B2|Baseline|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
941690|NCT00976274|B1|Baseline|Starch Capsule|5 capsules three times everyday for 12 weeks
941691|NCT00976274|P2|Participant Flow|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
941692|NCT00976274|P1|Participant Flow|Starch Capsule|5 capsules three times everyday for 12 weeks
941693|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
941694|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
941695|NCT00976274|O2|Outcome|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
941696|NCT00976274|O1|Outcome|Starch Capsule|5 capsules three times everyday for 12 weeks
941697|NCT00976274|E2|Reported Event|Korea Red Ginseng|5 capsules (300mg/capsule) three times everyday for 12 weeks
941698|NCT00976274|E1|Reported Event|Starch Capsule|5 capsules three times everyday for 12 weeks
941699|NCT00976248|B1|Baseline|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
941700|NCT00976248|P1|Participant Flow|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
941701|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001: Taken orally once a day"
941702|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001: Taken orally once a day"
941703|NCT00976248|O1|Outcome|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
941704|NCT00976248|E1|Reported Event|RAD001|"RAD001, oral, 10 mg, daily~RAD001 : Taken orally once a day"
941705|NCT00976209|B3|Baseline|Total|Total of all reporting groups
941706|NCT00976209|B2|Baseline|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
941707|NCT00976209|B1|Baseline|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
941782|NCT00975780|P1|Participant Flow|Usual Care|"The usual oral care provided at the nursing home~Usual oral care : Usual oral care and feeding positioning"
941708|NCT00976209|P2|Participant Flow|Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days.
941709|NCT00976209|P1|Participant Flow|Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR|Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days.
941710|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
941711|NCT00976209|O1|Outcome|All Participants|Participants received Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days and Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days in a cross-over fashion. A 3 day (+/- 1 day) washout period separated the two treatment periods.
941712|NCT00976209|E2|Reported Event|Phenylephrine HCl IR, 10 mg|Phenylephrine Hydrochloride (HCl) Immediate Release tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days.
941713|NCT00976209|E1|Reported Event|Phenylephrine HCl ER, 30 mg|Phenylephrine Hydrochloride (HCl) Extended Release (ER) tablets 30 mg taken every 12 hours, twice daily, for 3 days.
941714|NCT00976183|B1|Baseline|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
941757|NCT00975806|P1|Participant Flow|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
941867|NCT00975507|B2|Baseline|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
941715|NCT00976183|P1|Participant Flow|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
941716|NCT00976183|O1|Outcome|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
941717|NCT00976183|O1|Outcome|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
941718|NCT00976183|E1|Reported Event|Vorinostat|"All study patients will receive the indicated dose of Vorinostat in conjunction with paclitaxel and carboplatin.~Vorinostat: Vorinostat will start at 200 mg QD on weeks 1 and 3, and escalating to 300 mg QD after safety has been evaluated following 2 cycles of treatment. If safety is acceptable, then the following patients could be treated at 400 mg QD on weeks 1 and 3.~Vorinostat: Vorinostat will be given as a lead-in dose escalation starting at 200 mg QD."
941719|NCT00976027|B3|Baseline|Total|Total of all reporting groups
941720|NCT00976027|B2|Baseline|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
941721|NCT00976027|B1|Baseline|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
941722|NCT00976027|P2|Participant Flow|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
941723|NCT00976027|P1|Participant Flow|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
941724|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
941725|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
941726|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
941727|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
941728|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
941729|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
941730|NCT00976027|O2|Outcome|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
941731|NCT00976027|O1|Outcome|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
941732|NCT00976027|E2|Reported Event|Fluzone®|All subjects received a single dose of Fluzone vaccine on Day 0.
941733|NCT00976027|E1|Reported Event|Fluzone® High Dose|All participants received a single dose of Fluzone High Dose vaccine on Day 0.
941734|NCT00975975|B1|Baseline|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
941735|NCT00975975|P1|Participant Flow|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
941736|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
941737|NCT00975975|O1|Outcome|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
941739|NCT00975975|E1|Reported Event|Overall|Patients administered 40 mg of basiliximab as a single intravenous dose on day +7, +8, or +9 following infusion of allogeneic peripheral blood hematopoietic cells
941740|NCT00975923|B3|Baseline|Total|Total of all reporting groups
941741|NCT00975923|B2|Baseline|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
941742|NCT00975923|B1|Baseline|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
941743|NCT00975923|P2|Participant Flow|Tool Kit Group|One group of hospitals is allocated randomly to the Tool Kit Group
941744|NCT00975923|P1|Participant Flow|Collaborative Group|One group of hospitals is randomly allocated to the Collaborative Group
941745|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to only a Tool Kit of clinical guidelines and aides for quality improvement
941746|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
941747|NCT00975923|O2|Outcome|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for conducting quality improvement
941748|NCT00975923|O1|Outcome|Collaborative Group|Hospitals randomly allocated to the Virtual Collaborative involving teleconferences and Tool Kit
941749|NCT00975923|E2|Reported Event|Tool Kit Group|Hospitals allocated randomly to the Tool Kit containing evidence-based guidelines and aides for quality improvement
941750|NCT00975923|E1|Reported Event|Collaborative Group|Hospitals allocated randomly to the Collaborative Quality Improvement intervention with teleconferences and Tool Kit
941751|NCT00975806|B4|Baseline|Total|Total of all reporting groups
941752|NCT00975806|B3|Baseline|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941753|NCT00975806|B2|Baseline|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941754|NCT00975806|B1|Baseline|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg PO QD on Days 1 to 21 of each 21-day cycle
942650|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
941759|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941760|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
941761|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941762|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941763|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
941764|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941765|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941766|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
941767|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941768|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941769|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
941770|NCT00975806|O3|Outcome|Cohort G: Lenalidomide 15mg and Sunitinib 37.5mg|Lenalidomide 15 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941771|NCT00975806|O2|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941772|NCT00975806|O1|Outcome|Cohort A: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
941773|NCT00975806|O1|Outcome|Phase 2: Lenalidomide 10mg and Sunitinib 37.5 mg|Lenalidomide 10 mg and sunitinib 37.5 mg by mouth (PO) every day (QD) on Days 1 to 21 of each 21-day cycle
941774|NCT00975806|O1|Outcome|Cohort F: Lenalidomide 10mg and Sunitinib 37.5mg|Lenalidomide 10 mg PO QD on Days 1 to 21 and sunitinib 37.5 mg PO QD on Days 1 to 14 of each 21-day cycle
941775|NCT00975806|E3|Reported Event|Cohort G|Lenalidomide 15 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
941776|NCT00975806|E2|Reported Event|Cohort F|Lenalidomide 10 mg QD on Days 1-21 of each 21-day cycle and sunitinib 37.5 mg QD on Days 1-14 of each 21-day cycle
941777|NCT00975806|E1|Reported Event|Cohort A|Lenalidomide 10 mg QD and sunitinib 37.5 mg QD on Days 1-21 of each 21-day cycle
941778|NCT00975780|B3|Baseline|Total|Total of all reporting groups
941779|NCT00975780|B2|Baseline|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
941780|NCT00975780|B1|Baseline|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
941781|NCT00975780|P2|Participant Flow|Enhanced Oral Care|Enhanced Oral Care : oral brushing plus oral chlorhexidine plus upright feeding positioning
941786|NCT00975780|O1|Outcome|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
941787|NCT00975780|E2|Reported Event|Usual Oral Care|Study participants receiving 'Usual Oral Care' in the study.
941788|NCT00975780|E1|Reported Event|Enhanced Oral Care|Study participants receiving 'Enhanced Oral Care' in the study
941789|NCT00975715|B3|Baseline|Total|Total of all reporting groups
941790|NCT00975715|B2|Baseline|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941791|NCT00975715|B1|Baseline|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
941792|NCT00975715|P2|Participant Flow|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941793|NCT00975715|P1|Participant Flow|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
941794|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941795|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
941796|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941797|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
941798|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941799|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
941800|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941801|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
941802|NCT00975715|O2|Outcome|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941803|NCT00975715|O1|Outcome|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
942651|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
941804|NCT00975715|E2|Reported Event|Placebo|Participants received placebo to TRI476 without any adjustment to the dosing regimen, in addition to their traditional antiepileptics dosage.
941805|NCT00975715|E1|Reported Event|TRI476|Participants received TRI476 based on body weight with titration up to the maintenance dose, in addition to their traditional antiepileptics dosage.
941806|NCT00975689|B3|Baseline|Total|Total of all reporting groups
941807|NCT00975689|B2|Baseline|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
941808|NCT00975689|B1|Baseline|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
941809|NCT00975689|P2|Participant Flow|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
941810|NCT00975689|P1|Participant Flow|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
941811|NCT00975689|O2|Outcome|Placebo Phase|
941812|NCT00975689|O1|Outcome|NAC Phase|
941813|NCT00975689|E2|Reported Event|NAC Phase A/Placebo Phase B|These patients were randomized to receive study drug (NAC) in Phase A and placebo in Phase B
941814|NCT00975689|E1|Reported Event|Placebo Phase A/NAC Phase B|These patients were randomized to receive the placebo in Phase A and study drug (NAC) in Phase B of the trial
941815|NCT00975637|B6|Baseline|Total|Total of all reporting groups
941816|NCT00975637|B5|Baseline|Broda 70 mg|AMG 827: 70 mg SC
941817|NCT00975637|B4|Baseline|Placebo|Placebo: Placebo SC
941818|NCT00975637|B3|Baseline|Broda 280 mg|AMG 827: 280 mg SC
941819|NCT00975637|B2|Baseline|Broda 140 mg|AMG 827: 140 mg SC
941820|NCT00975637|B1|Baseline|Broda 210 mg|AMG 827: 210 mg SC
941821|NCT00975637|P5|Participant Flow|70 mg|AMG 827: 70 mg SC
941822|NCT00975637|P4|Participant Flow|Placebo|Placebo: Placebo SC
941823|NCT00975637|P3|Participant Flow|280 mg|AMG 827: 280 mg SC
941824|NCT00975637|P2|Participant Flow|140 mg|AMG 827: 140 mg SC
941825|NCT00975637|P1|Participant Flow|210 mg|AMG 827: 210 mg SC
941826|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
941827|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
941828|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
941829|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
941830|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
941831|NCT00975637|O5|Outcome|Broda 70 mg|AMG 827: 70 mg SC
941832|NCT00975637|O4|Outcome|Placebo|Placebo: Placebo SC
941833|NCT00975637|O3|Outcome|Broda 280 mg|AMG 827: 280 mg SC
941834|NCT00975637|O2|Outcome|Broda 140 mg|AMG 827: 140 mg SC
941835|NCT00975637|O1|Outcome|Broda 210 mg|AMG 827: 210 mg SC
941836|NCT00975637|E5|Reported Event|Broda 70 mg|AMG 827: 70 mg SC
941837|NCT00975637|E4|Reported Event|Placebo|Placebo: Placebo SC
941838|NCT00975637|E3|Reported Event|Broda 280 mg|AMG 827: 280 mg SC
941839|NCT00975637|E2|Reported Event|Broda 140 mg|AMG 827: 140 mg SC
941840|NCT00975637|E1|Reported Event|Broda 210 mg|AMG 827: 210 mg SC
941902|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
942024|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
941841|NCT00975611|B1|Baseline|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
941842|NCT00975611|P1|Participant Flow|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria, and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized (N=6), or completed (N=5), to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all consented/screened subjects (N=22) were published and are reported here.
941843|NCT00975611|O1|Outcome|All Consented Subjects|
941844|NCT00975611|E1|Reported Event|All Consented Subjects|Of the 22 consented subjects, 15 screen-failed because prolactin levels did not meet eligibility criteria and 1 screen-failed due to a positive drug screen. Because of this unanticipated high screen-failure rate, the study was terminated. Not enough subjects were randomized or completed to merit statistical analysis between study arms. Therefore, only the baseline characteristics of all 22 consented/screened subjects were published and are reported here.
941845|NCT00975585|B3|Baseline|Total|Total of all reporting groups
941846|NCT00975585|B2|Baseline|Lotrafilcon B|contact lens
941847|NCT00975585|B1|Baseline|Senofilcon A|contact lens
941848|NCT00975585|P2|Participant Flow|Lotrafilcon B|contact lens
941849|NCT00975585|P1|Participant Flow|Senofilcon A|contact lens
941850|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
941851|NCT00975585|O1|Outcome|Senofilcon A|contact lens
941852|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
941853|NCT00975585|O1|Outcome|Senofilcon A|contact lens
941854|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
941855|NCT00975585|O1|Outcome|Senofilcon A|contact lens
941856|NCT00975585|O2|Outcome|Lotrafilcon B at 4 Weeks|lotrafilcon B contact lens after four weeks of wear
941857|NCT00975585|O1|Outcome|Lotrafilcon B at 2 Weeks|lotrafilcon B contact lens after two weeks of wear
941858|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
941859|NCT00975585|O1|Outcome|Senofilcon A|contact lens
941860|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
941861|NCT00975585|O1|Outcome|Senofilcon A|contact lens
941862|NCT00975585|O2|Outcome|Lotrafilcon B|contact lens
941863|NCT00975585|O1|Outcome|Senofilcon A|contact lens
941864|NCT00975585|E2|Reported Event|Lotrafilcon B|contact lens
941868|NCT00975507|B1|Baseline|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
941869|NCT00975507|P2|Participant Flow|M-M-R™ II + VARIVAX™|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
941870|NCT00975507|P1|Participant Flow|ProQuad™ + Placebo Followed by ProQuad™|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
941871|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
941872|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
941873|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
941874|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
941875|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
941876|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
941877|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
941878|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
941879|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
941880|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
941881|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
941882|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
941883|NCT00975507|O3|Outcome|M-M-R™ II + VARIVAX™ (1 Injection)|
941884|NCT00975507|O2|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (2 Injection ProQuad™)|
941885|NCT00975507|O1|Outcome|ProQuad™+Placebo Followed by ProQuad™ - (1 Injection ProQuad™)|
941886|NCT00975507|E3|Reported Event|M-M-R™ II + VARIVAX™ (1 Injection)|VARIVAX™ + M-M-R™ II administered concomitantly at separate injection sites on Day 0.
941887|NCT00975507|E2|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (2 Injections)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0. Second dose of ProQuad™ containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) administered approximately 90 days (Day 90) after the first dose.
941903|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941888|NCT00975507|E1|Reported Event|ProQuad™ + Placebo Then ProQuad™ - ProQuad™ (1 Injection)|ProQuad™ (measles, mumps, rubella, and varicella vaccine) containing a high varicella component (~40,000 PFU/0.5 mL-dose) with a standard measles component (~3.7 log10 TCID50/0.5 mL dose) + placebo administered concomitantly at separate injection sites on Day 0.
941889|NCT00975481|B1|Baseline|Entire Study Population|Includes participants randomized to receive placebo first, alprazolam 1 mg first, alprazolam 3 mg first, dimebon 20 mg first, dimebon 40 mg first and dimebon 60 mg first.
941890|NCT00975481|P6|Participant Flow|DIM 60 mg, PBO, DIM 40 mg, ALP 1mg, DIM 20 mg, ALP 3 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention group; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
941891|NCT00975481|P5|Participant Flow|DIM 40 mg, DIM 60 mg, DIM 20 mg, PBO, ALP 3 mg, ALP 1 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fourth intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
941892|NCT00975481|P4|Participant Flow|DIM 20 mg, DIM 40 mg, ALP 3 mg, DIM 60 mg, ALP 1 mg, PBO|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the first intervention period; followed by dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then alprazolam 1mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
941959|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941893|NCT00975481|P3|Participant Flow|ALP 3 mg, DIM 20 mg, ALP 1 mg, DIM 40 mg, PBO, DIM 60 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the second intervention period; then alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fourth interventional period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the fifth intervention period; and dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of 7 days was maintained between each dose.
941894|NCT00975481|P2|Participant Flow|ALP 1 mg, ALP 3 mg, PBO, DIM 20 mg, DIM 60 mg, DIM 40 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the first intervention period; followed by alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the third intervention period; then dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 in the fourth intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 40 mg tablets, placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
941895|NCT00975481|P1|Participant Flow|PBO, ALP 1mg, DIM 60 mg, ALP 3 mg, DIM 40 mg, DIM 20 mg|Placebo (PBO) matched to 3 alprazolam (ALP) capsules and placebo matched to 3 dimebon (DIM) tablets on Day 1 in the first intervention period; followed by alprazolam 1 milligram (mg) capsule, placebo matched to 2 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 in the second intervention period; then dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 in the third intervention period; then alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 in fourth intervention period; then dimebon 40 mg tablets and placebo matched to dimebon tablet and placebo matched to 3 alprazolam capsules on Day 1 in the fifth intervention period; and dimebon 20 mg tablet, placebo matched to 2 dimebon tablets and placebo matched to 3 alprazolam capsules on Day 1 in the sixth intervention period. A washout period of at least 7 days was maintained between each dose.
941896|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941897|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941898|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941899|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941900|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941901|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941904|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941905|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941906|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941907|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941908|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941909|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941910|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941911|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941912|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941913|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941914|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941915|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941916|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941917|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941918|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941919|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941920|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
942157|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
941921|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941922|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941923|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941924|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941925|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941926|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941927|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941928|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941929|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941930|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941931|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941932|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941933|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941934|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941935|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941936|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941937|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941938|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941939|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941940|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941941|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941942|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941943|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941944|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941945|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941946|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941947|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941948|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941949|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941950|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941951|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941952|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941953|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941954|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941955|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941956|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941957|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941958|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941960|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941961|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941962|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941963|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941964|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941965|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941966|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsule, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941967|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941968|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941969|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941970|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941971|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941972|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam tablets, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941973|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941974|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941975|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to 1 dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941976|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941977|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941978|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941979|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941980|NCT00975481|O6|Outcome|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941981|NCT00975481|O5|Outcome|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941982|NCT00975481|O4|Outcome|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941983|NCT00975481|O3|Outcome|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941984|NCT00975481|O2|Outcome|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941985|NCT00975481|O1|Outcome|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941986|NCT00975481|E6|Reported Event|Dimebon 60 mg|Dimebon 60 mg tablets and placebo matched to 3 alprazolam capsules on Day 1 of any of the six interventional periods.
941987|NCT00975481|E5|Reported Event|Dimebon 40 mg|Dimebon 40 mg tablets, placebo matched to dimebon tablet, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941988|NCT00975481|E4|Reported Event|Dimebon 20 mg|Dimebon 20 mg tablet, placebo matched to 2 dimebon tablets, and placebo matched to 3 alprazolam capsules on Day 1 of any of the six intervention periods.
941989|NCT00975481|E3|Reported Event|Alprazolam 3 mg|Alprazolam 3 mg capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941990|NCT00975481|E2|Reported Event|Alprazolam 1 mg|Alprazolam 1 mg capsule, placebo matched to 2 alprazolam capsules, and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941991|NCT00975481|E1|Reported Event|Placebo|Placebo matched to 3 alprazolam capsules and placebo matched to 3 dimebon tablets on Day 1 of any of the six intervention periods.
941992|NCT00975416|B3|Baseline|Total|Total of all reporting groups
941993|NCT00975416|B2|Baseline|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal Placebo given in the context of cognitive behavioral therapy"
941994|NCT00975416|B1|Baseline|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
941995|NCT00975416|P2|Participant Flow|Inpatient Cocaine Placebo|Placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients Placebo given in the context of cognitive behavioral therapy
941996|NCT00975416|P1|Participant Flow|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
941997|NCT00975416|O2|Outcome|Inpatient Cocaine Placebo|"Intranasal placebo administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Intranasal placebo given in the context of cognitive behavioral therapy"
941998|NCT00975416|O1|Outcome|Inpatient Cocaine Oxytocin|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
941999|NCT00975416|E3|Reported Event|Inpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent inpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
942000|NCT00975416|E2|Reported Event|Outpatient Cocaine|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to cocaine dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
942001|NCT00975416|E1|Reported Event|Methadone|"Intranasal oxytocin administered in the context of cognitive behavioral therapy to methadone dependent outpatients~Oxytocin Nasal Spray: Intranasal oxytocin given in the context of cognitive behavioral therapy"
942002|NCT00975286|B3|Baseline|Total|Total of all reporting groups
942003|NCT00975286|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
942004|NCT00975286|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
942005|NCT00975286|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
942006|NCT00975286|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
942007|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942008|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942009|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942010|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942011|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942012|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942013|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942014|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942015|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942016|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942017|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942018|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942019|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942020|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942021|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942025|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942026|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942027|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942028|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942029|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942030|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942031|NCT00975286|O2|Outcome|Lixisenatide|2-step initiation regimen of lixisenatide.
942032|NCT00975286|O1|Outcome|Placebo|2-step initiation regimen of volume matching placebo.
942033|NCT00975286|E2|Reported Event|Lixisenatide|2-step initiation regimen of lixisenatide.
942034|NCT00975286|E1|Reported Event|Placebo|2-step initiation regimen of volume matching placebo.
942035|NCT00975221|B3|Baseline|Total|Total of all reporting groups
942036|NCT00975221|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942037|NCT00975221|B1|Baseline|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942038|NCT00975221|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942039|NCT00975221|P1|Participant Flow|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942040|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942041|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942042|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942043|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942044|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942045|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942078|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
951311|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
942046|NCT00975221|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the efficacy assessment phase and then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942047|NCT00975221|O1|Outcome|Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase. Participants then continued into the open-label extension phase and received cinacalcet at a starting dose of 30 mg BID for 24 weeks. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942048|NCT00975221|E4|Reported Event|Open-label Phase: Previous Cinacalcet|Participants who received cinacalcet during the double-blind phase continued to receive cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942049|NCT00975221|E3|Reported Event|Open-label Phase: Previous Placebo|Participants who received placebo during the double-blind phase (Weeks 1-28) then received cinacalcet at a starting dose of 30 mg BID for 24 weeks in the open-label extension phase. The dose of cinacalcet could have been increased or decreased as needed to maintain a corrected total serum calcium concentration within the normal range through Week 52.
942050|NCT00975221|E2|Reported Event|Double-blind Phase: Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally BID and were eligible for a dose titration once every 3 weeks during the 12-week double-blind dose-titration phase based on corrected total serum calcium concentration and safety assessments. Participants continued to receive cinacalcet for another 16 weeks during the double-blind efficacy assessment phase.
942051|NCT00975221|E1|Reported Event|Double-blind Phase: Placebo|Participants received placebo orally twice a day (BID) for 12 weeks during the dose titration phase and for another 16 weeks during the efficacy assessment phase.
942052|NCT00975195|B3|Baseline|Total|Total of all reporting groups
942053|NCT00975195|B2|Baseline|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942158|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942054|NCT00975195|B1|Baseline|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942055|NCT00975195|P2|Participant Flow|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942056|NCT00975195|P1|Participant Flow|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942057|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942058|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942059|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942060|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942061|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942062|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942063|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942064|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942065|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942066|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942067|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942068|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942100|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
951445|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
942069|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942070|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942071|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942072|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942073|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942074|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942075|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942076|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942077|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942138|NCT00975143|E1|Reported Event|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942079|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942080|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942081|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942082|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942083|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942084|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942085|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942086|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942087|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942088|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942089|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942090|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942091|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942092|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942093|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942139|NCT00975130|B1|Baseline|GLM50-SC|Participants received 50 mg of golimumab subcutaneously once monthly for a period of 6 months. 3280 enrolled participants were included in the Efficacy-Evaluable population; baseline characteristics are presented for this population.
942094|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942095|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942096|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942097|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942098|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942099|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942101|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942102|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942103|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942104|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942105|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942106|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942107|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942108|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942140|NCT00975130|P3|Participant Flow|SC-GLM50|Participants achieving good or moderate response but not in remission at the end of Study Part 1, received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
942185|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
951312|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
942109|NCT00975195|O2|Outcome|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942110|NCT00975195|O1|Outcome|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942111|NCT00975195|E2|Reported Event|Fluticasone Withdrawal|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d.and 50 μg salmeterol b.i.d. for 52 weeks, in combination with a stepwise withdrawal of fluticasone, consisting of 250μg fluticasone b.i.d for 6 weeks, followed by 100μg fluticasone b.i.d for 6 weeks, followed by placebo for 40 weeks (randomised treatment period).
942112|NCT00975195|E1|Reported Event|Fluticasone Maintenance|18μg tiotropium administered by oral inhalation once daily (q.d.), 50μg salmeterol and 500μg fluticasone, each administered by oral inhalation twice daily (b.i.d) for 6 weeks (open-label run in period), followed by 18 μg tiotropium q.d., 50 μg salmeterol b.i.d.,and 500 μg fluticasone b.i.d. for 52 weeks (randomised treatment period).
942113|NCT00975156|B3|Baseline|Total|Total of all reporting groups
942114|NCT00975156|B2|Baseline|Standard of Care|Conventional physical therapy
942115|NCT00975156|B1|Baseline|Lokomat Intervention|
942116|NCT00975156|P2|Participant Flow|Standard of Care|Conventional physical therapy
942117|NCT00975156|P1|Participant Flow|Lokomat Intervention|
942118|NCT00975156|O3|Outcome|All Participants 6MWD Outcome|Baseline, Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
942119|NCT00975156|O2|Outcome|Standard of Care 6MWD Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
942120|NCT00975156|O1|Outcome|Lokomat Intervention 6 Minute Walking Distance (6MWD) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessments were completed by a blinded assessor.
942652|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
942121|NCT00975156|O3|Outcome|All Participants 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
942122|NCT00975156|O2|Outcome|Standard of Care 10mWT Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
942123|NCT00975156|O1|Outcome|Lokomat Intervention 10-meter Walking Test (10mWT) Outcome|Baseline, 1-Week Post-Intervention (study mean of 5.05 days since last therapy session), 3-Month Post-Intervention assessment values measured by a blinded assessor.
942124|NCT00975156|E2|Reported Event|Standard of Care|Conventional physical therapy
942125|NCT00975156|E1|Reported Event|Lokomat Intervention|Robotic-assisted gait therapy
942126|NCT00975143|B3|Baseline|Total|Total of all reporting groups
942127|NCT00975143|B2|Baseline|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942128|NCT00975143|B1|Baseline|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942129|NCT00975143|P2|Participant Flow|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942130|NCT00975143|P1|Participant Flow|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942131|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942132|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942133|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942134|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942135|NCT00975143|O2|Outcome|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942136|NCT00975143|O1|Outcome|CIP-Isotretinoin|CIP-Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942137|NCT00975143|E2|Reported Event|Isotretinoin|(Generic) Isotretinoin 10 mg and 20 mg capsules taken with meals, at an initial titration dose of approximately 0.5 mg/kg/day, divided into 2 doses for the first 4 weeks, followed by approximately 1 mg/kg/day divided into 2 doses for 16 weeks
942325|NCT00975000|B1|Baseline|Placebo|Participants received placebo orally once daily for 52 weeks.
942141|NCT00975130|P2|Participant Flow|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|Participants achieving good or moderate response but not in remission at the conclusion of Study Part 1 received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab at a dose of 50 mg once monthly.
942142|NCT00975130|P1|Participant Flow|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months in Study Part 1.
942143|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
942144|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|Participants received IV GLM at a dose of 2 mg/kg until remission is achieved at which time they were switched to SC GLM at a dose of 50 mg once monthly.
942145|NCT00975130|O2|Outcome|SC-GLM50|Participants received SC GLM at a dose of 50 mg once monthly.
942146|NCT00975130|O1|Outcome|IV-GLM 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched to subcutaneous golimumab~at a dose of 50 mg once monthly."
942147|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
942148|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942149|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942150|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942151|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942152|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942153|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942154|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942155|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942156|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942159|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942160|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942161|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942162|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942163|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
942164|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942165|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942166|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942167|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942168|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942169|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942170|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942171|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942172|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942173|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942174|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942175|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942176|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942177|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942178|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942179|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
942180|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
942181|NCT00975130|O1|Outcome|GLM50-SC|In Part 1 of the trial, participants received subcutaneous golimumab 50 mg once monthly.
942182|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942183|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942184|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
951313|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
942186|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942187|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942188|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942189|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942190|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942191|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942192|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942193|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942194|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942195|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942196|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942197|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942198|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942199|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942200|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942201|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942202|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942203|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942204|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942205|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942206|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942207|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942208|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942209|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942210|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942211|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942212|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942213|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942214|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942215|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942216|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942217|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942218|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942219|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942220|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942221|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942222|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942223|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942224|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942225|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942226|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942227|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942228|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942229|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942230|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942231|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942232|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942233|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942234|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942235|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942236|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942237|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942238|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942239|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942240|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942241|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942242|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942243|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942244|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942245|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942246|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942247|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942248|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942249|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942250|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942251|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942252|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942253|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942254|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942255|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942256|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942257|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942258|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942259|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942260|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942261|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942262|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942263|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942264|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942265|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942266|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942267|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942268|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942269|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942270|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942271|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942272|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942273|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942274|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942275|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942276|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942277|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942278|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942279|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942280|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942281|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942282|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942283|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942284|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942285|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942286|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942287|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942288|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942289|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942290|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942291|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942292|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942293|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942294|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942295|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942296|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942297|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942298|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942299|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942300|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942301|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942302|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942303|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942304|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942305|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942306|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942307|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942308|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942309|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942310|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942311|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942312|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942313|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942314|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942315|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942316|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly for 6 months (study Month 1 to Month 6).
942317|NCT00975130|O2|Outcome|SC-GLM50|Subcutaneous golimumab 50 mg administered once monthly for for 6 months (study Months 6-12).
942318|NCT00975130|O1|Outcome|IV-GLM2/SC-GLM50|Intravenous golimumab 2 mg/kg followed by subcutaneous golimumab 50 mg once monthly.
942319|NCT00975130|O1|Outcome|GLM50-SC|Participants received subcutaneous golimumab 50 mg once monthly.
942320|NCT00975130|E3|Reported Event|SC-GLM50|Participants received subcutaneous golimumab at a dose of 50 mg once monthly for a period of 6 months in Part 2 of the study.
942321|NCT00975130|E2|Reported Event|Intravenous GLM (IV-GLM) 2 mg/kg + SC GLM 50 mg|"Participants received IV-GLM at a dose of 2 mg/kg at the start of Month 7, start of Month 8, and start of Month 10 if remission was not achieved at any of these IV administration visits. If remission was achieved, participants were switched subcutaneous golimumab~at a dose of 50 mg once monthly."
942322|NCT00975130|E1|Reported Event|Golimumab 50 mg Subcutaneous (GLM50-SC)|Participants received GLM50-SC once monthly for a period of 6 months.
942323|NCT00975000|B3|Baseline|Total|Total of all reporting groups
942324|NCT00975000|B2|Baseline|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942326|NCT00975000|P2|Participant Flow|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on intact parathyroid hormone (iPTH) values, corrected total serum calcium values, and safety assessments.
942327|NCT00975000|P1|Participant Flow|Placebo|Participants received placebo orally once daily for 52 weeks.
942328|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942329|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942330|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942331|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942332|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942333|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942334|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942335|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942336|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942337|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942338|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942339|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942340|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942341|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942342|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942343|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942344|NCT00975000|O2|Outcome|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942345|NCT00975000|O1|Outcome|Placebo|Participants received placebo orally once daily for 52 weeks.
942346|NCT00975000|E2|Reported Event|Cinacalcet|Participants received cinacalcet at a starting dose of 30 mg orally once daily for 52 weeks. Cinacalcet dose was titrated every 4 weeks during the dose-titration phase and during study visits in the maintenance phase based on the iPTH values, corrected total serum calcium values, and safety assessments.
942347|NCT00975000|E1|Reported Event|Placebo|Participants received placebo orally once daily for 52 weeks.
942348|NCT00974974|B3|Baseline|Total|Total of all reporting groups
942349|NCT00974974|B2|Baseline|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
942350|NCT00974974|B1|Baseline|IPX066|Investigational product IPX066
942351|NCT00974974|P2|Participant Flow|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
942352|NCT00974974|P1|Participant Flow|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
942353|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
942354|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
942355|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
942356|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
942357|NCT00974974|O2|Outcome|IR CD-LD (Active Comparator)|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IR CD-LD (active comparator).
942358|NCT00974974|O1|Outcome|IPX066|Following IR CD-LD dose adjustment and conversion to IPX066, subjects were assigned to Investigational product IPX066.
942359|NCT00974974|E2|Reported Event|Carbidopa-Levodopa|Immediate-release carbidopa and levodopa
942360|NCT00974974|E1|Reported Event|IPX066|Investigational product IPX066
942361|NCT00974818|B3|Baseline|Total|Total of all reporting groups
942387|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942362|NCT00974818|B2|Baseline|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
942363|NCT00974818|B1|Baseline|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
942364|NCT00974818|P2|Participant Flow|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
942365|NCT00974818|P1|Participant Flow|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
942366|NCT00974818|O2|Outcome|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
942407|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942653|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
942367|NCT00974818|O1|Outcome|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
942368|NCT00974818|E2|Reported Event|Bacillus Calmette-Guerin (BCG)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of either BCG, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Bacillus Calmette-Guerin (BCG): Patients randomized to this group will receive six weekly cycles of 81 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline). Patients will receive three weekly cycles of 27 mg of intravesical BCG (dissolved in a total volume of 53 mL of diluent and saline) 3, 6, 12, 18, and 24 months after the induction course."
942369|NCT00974818|E1|Reported Event|Mitomycin C (MMC)|"Patients will receive a induction course of 6 cycles of weekly intravesical therapy of MMC, followed by a maintenance schedule consisting of 3 weekly cycles of the same drug at 3, 6, 12, 18, and 24 months.~Mitomycin C (MMC): Patients randomized to this group will receive six weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water). Patients will receive three weekly cycles of 40 mg of intravesical MMC (dissolved in a total volume of 20 mL sterile water) 3, 6, 12, 18, and 24 months after the induction course."
942370|NCT00974675|B5|Baseline|Total|Total of all reporting groups
942371|NCT00974675|B4|Baseline|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
942372|NCT00974675|B3|Baseline|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942373|NCT00974675|B2|Baseline|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942374|NCT00974675|B1|Baseline|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942375|NCT00974675|P4|Participant Flow|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
942376|NCT00974675|P3|Participant Flow|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942377|NCT00974675|P2|Participant Flow|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942378|NCT00974675|P1|Participant Flow|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942379|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942380|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942381|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942382|NCT00974675|O4|Outcome|Placebp|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
942383|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942384|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942385|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942386|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942388|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942389|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942390|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942391|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942392|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942393|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942394|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942395|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942396|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942397|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942398|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942399|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942400|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942401|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942402|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942403|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942404|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942405|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942406|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
951446|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
942409|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942410|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942411|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942412|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942413|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942414|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942415|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942416|NCT00974675|O3|Outcome|CAT-354 10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942417|NCT00974675|O2|Outcome|CAT-354 5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942418|NCT00974675|O1|Outcome|CAT-354 1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942419|NCT00974675|E4|Reported Event|Placebo|Placebo matched to CAT-354 intravenous infusion over 30 minutes on Day 0, 28 and 56.
942420|NCT00974675|E3|Reported Event|10 mg/kg|CAT-354 10 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942421|NCT00974675|E2|Reported Event|5 mg/kg|CAT-354 5 mg/kg of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942422|NCT00974675|E1|Reported Event|1 mg/kg|CAT-354 1 milligram/kilogram (mg/kg) of body weight intravenous infusion over 30 minutes on Day 0, 28 and 56.
942423|NCT00974571|B4|Baseline|Total|Total of all reporting groups
942424|NCT00974571|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942425|NCT00974571|B2|Baseline|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942426|NCT00974571|B1|Baseline|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942427|NCT00974571|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942428|NCT00974571|P2|Participant Flow|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942429|NCT00974571|P1|Participant Flow|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942430|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942431|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942432|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942433|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942434|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942435|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942436|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942437|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942438|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942439|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942440|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942441|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942442|NCT00974571|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942443|NCT00974571|O2|Outcome|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942444|NCT00974571|O1|Outcome|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942445|NCT00974571|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942446|NCT00974571|E2|Reported Event|Cetirizine 10 mg|Montelukast matching-image placebo tablet and cetirizine 10-mg tablet orally once daily at bedtime for 6 weeks.
942447|NCT00974571|E1|Reported Event|Montelukast 10 mg|Montelukast 10-mg film-coated tablet and cetirizine matching-image placebo tablet orally once daily at bedtime for 6 weeks.
942448|NCT00974480|B4|Baseline|Total|Total of all reporting groups
942449|NCT00974480|B3|Baseline|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942654|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942655|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942450|NCT00974480|B2|Baseline|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942451|NCT00974480|B1|Baseline|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942452|NCT00974480|P3|Participant Flow|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942453|NCT00974480|P2|Participant Flow|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942454|NCT00974480|P1|Participant Flow|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942455|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942456|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942457|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942458|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942459|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942460|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942461|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942462|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942463|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942464|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942465|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942466|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942467|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942468|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942469|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942518|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942470|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942471|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942472|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942473|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942474|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942475|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942476|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942477|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942478|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942479|NCT00974480|O6|Outcome|Combination of Redermic and Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942480|NCT00974480|O5|Outcome|Rejuva-A - Assessor 2|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942481|NCT00974480|O4|Outcome|Redermic - Assessor 2|Cream applied twice a day every day, morning and evening for 24 weeks.
942509|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942482|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942483|NCT00974480|O2|Outcome|Rejuva-A - Assessor 1|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942484|NCT00974480|O1|Outcome|Redermic - Assessor 1|Cream applied twice a day every day, morning and evening for 24 weeks.
942485|NCT00974480|O3|Outcome|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942486|NCT00974480|O2|Outcome|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942487|NCT00974480|O1|Outcome|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942488|NCT00974480|E3|Reported Event|Combination of Redermic and Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remain there until the end of study. Redermic was applied every evening when Rejuva-A™ was not applied, as well as every morning.
942489|NCT00974480|E2|Reported Event|Rejuva-A|Week 1, Rejuva-A cream was applied to face in the evening twice a week. Weeks 2 & 3, Rejuva-A cream was applied to the face in the evening three times a week. Weeks 4-24, Rejuva-A cream was applied to the face in the evening every other day. In cases of intolerance, subjects returned to the previous dosage and remained there until the end of study. Neutral cream was applied to the face in the morning every day for 24 weeks.
942490|NCT00974480|E1|Reported Event|Redermic|Cream applied twice a day every day, morning and evening for 24 weeks.
942491|NCT00974376|B3|Baseline|Total|Total of all reporting groups
942492|NCT00974376|B2|Baseline|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
942493|NCT00974376|B1|Baseline|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
942494|NCT00974376|P2|Participant Flow|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
942495|NCT00974376|P1|Participant Flow|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
942496|NCT00974376|O2|Outcome|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
942497|NCT00974376|O1|Outcome|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
942498|NCT00974376|E2|Reported Event|Placebo|Matched placebo given in conjunction with standardized manual-guided behavioral counseling.
942499|NCT00974376|E1|Reported Event|Gabapentin 1200mg/Day|1200mg/day of gabapentin given in conjunction with standardized manual-guided behavioral counseling.
942500|NCT00974363|B3|Baseline|Total|Total of all reporting groups
942501|NCT00974363|B2|Baseline|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942502|NCT00974363|B1|Baseline|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942503|NCT00974363|P2|Participant Flow|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942504|NCT00974363|P1|Participant Flow|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942505|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942506|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942507|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942508|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
951314|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
942510|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942511|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942512|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942513|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942514|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942515|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942516|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942517|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942519|NCT00974363|O2|Outcome|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942520|NCT00974363|O1|Outcome|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942521|NCT00974363|E2|Reported Event|Mencevax™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Mencevax™ (MenACWY) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942522|NCT00974363|E1|Reported Event|Nimenrix™ Group|Healthy adolescents and young adults between and including 11 to 17 years of age, who were previously vaccinated in the primary study MenACWY-TT-036 (109069) with a single dose of Nimenrix™ (MenACWY-TT) vaccine, intramuscularly into the deltoid region of the non-dominant arm.
942523|NCT00974311|B3|Baseline|Total|Total of all reporting groups
942524|NCT00974311|B2|Baseline|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942525|NCT00974311|B1|Baseline|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942526|NCT00974311|P2|Participant Flow|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942527|NCT00974311|P1|Participant Flow|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942528|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942529|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942530|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942531|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942532|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942533|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942686|NCT00973622|P2|Participant Flow|Non-smokers|Healthy adult non-smokers who were between the ages of aged 19-55 years.
942534|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942535|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942536|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942537|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942538|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942539|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942540|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942541|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942542|NCT00974311|O2|Outcome|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942543|NCT00974311|O1|Outcome|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942611|NCT00973765|P1|Participant Flow|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
942544|NCT00974311|E2|Reported Event|Placebo|Participants received placebo tablets orally once a day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942545|NCT00974311|E1|Reported Event|Enzalutamide|Participants received 160 mg Enzalutamide orally per day. Treatment continued until unacceptable toxicity, confirmed disease progression and the patient was scheduled to initiate a new systemic antineoplastic therapy, death, or withdrawal.
942546|NCT00974246|B1|Baseline|Baseline Characteristics|Nursing Home residents with either a confirmed diagnosis of COPD or an FEV1/FVC ratio <0.7 or in treatment with anticholinergic drugs.
942547|NCT00974246|P1|Participant Flow|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
942548|NCT00974246|O1|Outcome|Study Population:|The study sample (n=27) were nursing home residents with either (1) a confirmed diagnosis of COPD, (2) an FEV1/FVC ratio <0.7 or (3) in treatment with anticholinergic drugs.
942549|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
942550|NCT00974246|O1|Outcome|Nursing Home Residents With COPD|The effect of Advair Diskus treatment on depression in nursing home residents with Chronic Obstructive Pulmonary Disease.
942551|NCT00974246|E1|Reported Event|Adverse Events|All enrolled subjects.
942552|NCT00974220|B3|Baseline|Total|Total of all reporting groups
942553|NCT00974220|B2|Baseline|Fentanyl - Placebo (Order)|nebulized fentanyl citrate in period 1, nebulized saline placebo in period 2.
942554|NCT00974220|B1|Baseline|Placebo - Fentanyl (Order)|nebulized saline placebo in period 1, nebulized fentanyl citrate in period 2.
942555|NCT00974220|P2|Participant Flow|Fentanyl - Placebo (Order)|nebulized fentanyl citrate (50 mcg) in period 1, nebulized 0.9% saline placebo in period 2
942556|NCT00974220|P1|Participant Flow|Placebo - Fentanyl (Order)|nebulized 0.9% saline placebo in period 1, nebulized fentanyl citrate 50mcg in period 2
942557|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
942558|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
942559|NCT00974220|O2|Outcome|Fentanyl|nebulized fentanyl citrate (50 mcg)
942560|NCT00974220|O1|Outcome|Placebo|nebulized 0.9% saline placebo
942561|NCT00974220|E2|Reported Event|Fentanyl|nebulized fentanyl citrate (50 mcg)
942562|NCT00974220|E1|Reported Event|Placebo|nebulized 0.9% saline placebo
942563|NCT00974090|B3|Baseline|Total|Total of all reporting groups
942564|NCT00974090|B2|Baseline|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942565|NCT00974090|B1|Baseline|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942566|NCT00974090|P2|Participant Flow|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942567|NCT00974090|P1|Participant Flow|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942568|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942569|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942688|NCT00973622|O2|Outcome|Non-smokers|Healthy adult non-smokers aged 19-55
942570|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942571|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942572|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942573|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942574|NCT00974090|O2|Outcome|Teneli / Teneli + SU|Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942575|NCT00974090|O1|Outcome|Placebo / Teneli + SU|Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride
942576|NCT00974090|E4|Reported Event|Teneli/Teneli + SU (Data Through Week 52)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
942577|NCT00974090|E3|Reported Event|Placebo/Teneli + SU (Data From Week 12 to Week 52)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 12 to Week 52 were shown.~MedDRA 13.1"
942578|NCT00974090|E2|Reported Event|Teneli/Teneli + SU (Data Through Week 12)|"Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
942579|NCT00974090|E1|Reported Event|Placebo/Teneli + SU (Data Through Week 12)|"Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with glimepiride. The adverse events which occured from Week 0 to Week 12 were shown.~MedDRA 13.0"
942612|NCT00973765|O2|Outcome|Placebo|Matched placebo 2 pills po BID x 7 days
942613|NCT00973765|O1|Outcome|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
942614|NCT00973765|E2|Reported Event|Placebo|Matched placebo 2 pills po BID x 7 days
942580|NCT00974051|B1|Baseline|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
942581|NCT00974051|P3|Participant Flow|20% Basal Reduction First, Then Control, Then Terbutaline|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
942582|NCT00974051|P2|Participant Flow|Terbutaline First, Then 20% Basal Reduction, Then Control|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
942583|NCT00974051|P1|Participant Flow|Control First, Then Terbutaline, Then 20% Basal Reduction|Subjects complete the same exercise routine. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
942584|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
942585|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
942586|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
942587|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
942588|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
942589|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
942590|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
942591|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
942592|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
942593|NCT00974051|O3|Outcome|20% Basal Reduction Arm|Subjects complete the same exercise routine. A 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night. Glucose levels from 9 pm to 6 am are analyzed.
942594|NCT00974051|O2|Outcome|Terbutaline Arm|2.5 mg oral terbutaline is given at 9pm during the Terbutaline night. Glucose levels from 9 pm to 6 am are analyzed.
942595|NCT00974051|O1|Outcome|Control Arm|No treatment is given during the Control night. Glucose levels from 9 pm to 6 am are analyzed.
942596|NCT00974051|E4|Reported Event|20% Basal Reduction Arm|During 20% basal reduction night
942597|NCT00974051|E3|Reported Event|Terbutaline Arm|During turbutaline intervention night
942598|NCT00974051|E2|Reported Event|Control Arm|during control intervention night
942599|NCT00974051|E1|Reported Event|All Study Subjects|Subjects complete the same exercise routine. Subjects serve as there own control and participate in all interventions. No treatment is given during the Control night, Terbutaline is given at 9pm during the Terbutaline night, a 20% basal reduction is done starting at 9pm for six hours on the 20% basal reduction night.
942600|NCT00973921|B1|Baseline|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
942689|NCT00973622|O1|Outcome|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
942601|NCT00973921|P1|Participant Flow|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
942602|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
942603|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
942604|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
942605|NCT00973921|O1|Outcome|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
942606|NCT00973921|E1|Reported Event|Coronary Stenting Evaluation With IVUS|The study group consisted of patients who were scheduled for coronary artery stent placement procedures in which stent deployment evaluations with Intravascular Ultrasound (IVUS), Quantitative Coronary Angiography (QCA) and StentOptimizer (SO) software were clinically indicated.
942607|NCT00973765|B3|Baseline|Total|Total of all reporting groups
942608|NCT00973765|B2|Baseline|Placebo|Matched placebo 2 pills po BID x 7 days
942609|NCT00973765|B1|Baseline|Active Comparator|Bactrim DS (800/160) 2 pills po BID x 7 days
942610|NCT00973765|P2|Participant Flow|Placebo|Matched placebo 2 pills po BID x 7 days
951447|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
942616|NCT00973752|B1|Baseline|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
942617|NCT00973752|P1|Participant Flow|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS (central nervous system), Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
942618|NCT00973752|O1|Outcome|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
942619|NCT00973752|E1|Reported Event|Experimental|"All patients treated on same arm~Prednisone: Orally during Induction, Consolidation 1, CNS, Consolidation 2, and Continuation therapy.~Vincristine: Intravenously during Induction, CNS, Consolidation 2 and Continuation Therapy~Doxorubicin: Intravenously during Induction, CNS, and Consolidation 2 therapy~PEG-asparaginase: Intravenously during Induction, Consolidation 1, CNS, and Consolidation 2 therapy~Cytarabine: Intrathecally during Induction and CNS therapy~Methotrexate: Intrathecally during Induction, CNS, and Continuation Therapy~Imatinib: Orally during Induction, Consolidation 1, CNS, Consolidation 2 and Continuation Therapy~Clofarabine: Intravenously during Consolidation 1 Therapy~6 Mercaptopurine: Orally during CNS, Consolidation 2 and Continuation Therapy"
942620|NCT00973739|B1|Baseline|Lapatinib|Lapatinib will be administered
942621|NCT00973739|P1|Participant Flow|Lapatinib|Lapatinib will be administered
942622|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
942623|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
942687|NCT00973622|P1|Participant Flow|Smokers|Smokers were healthy adults between the ages of 19 and 55 years who had no intention of quitting smoking before the end of the study.
942624|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
942625|NCT00973739|O1|Outcome|Lapatinib|"Lapatinib PO dosed according to age:~Children/adolescents (less than 18 years of age): 1,800 mg/m2/day PO divided into twice daily doses, to a maximum of 750 mg PO twice daily~Adults (18 years of age or older): 1,500 mg PO once daily~Lapatinib is available in 250 mg tablets only. For pediatric dosing, the total daily dose will be rounded up or down to the nearest 250 mg increment."
942626|NCT00973739|E1|Reported Event|Lapatinib|Lapatinib will be administered
942627|NCT00973700|B6|Baseline|Total|Total of all reporting groups
942628|NCT00973700|B5|Baseline|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942629|NCT00973700|B4|Baseline|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942630|NCT00973700|B3|Baseline|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942631|NCT00973700|B2|Baseline|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
942632|NCT00973700|B1|Baseline|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
942633|NCT00973700|P5|Participant Flow|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942634|NCT00973700|P4|Participant Flow|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942635|NCT00973700|P3|Participant Flow|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942636|NCT00973700|P2|Participant Flow|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
942637|NCT00973700|P1|Participant Flow|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
942638|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942639|NCT00973700|O4|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942640|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942641|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
942642|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
942643|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942644|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942645|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942656|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942657|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
942658|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
942659|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942660|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942661|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942662|NCT00973700|O3|Outcome|2x15_1_22|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942663|NCT00973700|O2|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942664|NCT00973700|O1|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942665|NCT00973700|O5|Outcome|2x15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
942666|NCT00973700|O4|Outcome|15_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
942667|NCT00973700|O3|Outcome|7.5adj_1_22|A/H1N1 7.5 mcg with MF59; two doses on day 1
942668|NCT00973700|O2|Outcome|7.5adj_1_8|A/H1N1 7.5 mcg with MF59; two doses on day 1
942669|NCT00973700|O1|Outcome|2x7.5adj|A/H1N1 7.5 mcg with MF59; two doses on day 1
942670|NCT00973700|O1|Outcome|15_1_22|A/H1N1 on study days 1 and 22
942671|NCT00973700|O1|Outcome|15_1_22|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942672|NCT00973700|E11|Reported Event|2x15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942673|NCT00973700|E10|Reported Event|15_1_22 (3 to <9 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942674|NCT00973700|E9|Reported Event|7.5adj_1_22 (3 to <9 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942675|NCT00973700|E8|Reported Event|2x15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942676|NCT00973700|E7|Reported Event|15_1_22 (9 to 17 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942677|NCT00973700|E6|Reported Event|7.5adj_1_22 (9 to 17 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942678|NCT00973700|E5|Reported Event|2x15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; two doses on days 1 and 22
942679|NCT00973700|E4|Reported Event|15_1_22 (18 to 64 Yrs)|A/H1N1 15 mcg no MF59; one dose on days 1 and 22
942680|NCT00973700|E3|Reported Event|7.5adj_1_22 (18-64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 22
942681|NCT00973700|E2|Reported Event|7.5adj_1_8 (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; one dose on days 1 and 8
942682|NCT00973700|E1|Reported Event|2x7.5adj (18 to 64 Yrs)|A/H1N1 7.5 mcg with MF59; two doses on day 1
942683|NCT00973622|B3|Baseline|Total|Total of all reporting groups
942684|NCT00973622|B2|Baseline|Nonsmokers|
942685|NCT00973622|B1|Baseline|Smokers|
942690|NCT00973622|E2|Reported Event|Non-smokers|Healthy adult non-smokers aged 19-55
942691|NCT00973622|E1|Reported Event|Smokers|Healthy adult smokers aged 19-55 who are not currently interested in quitting smoking.
942692|NCT00973479|B3|Baseline|Total|Total of all reporting groups
942693|NCT00973479|B2|Baseline|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
942694|NCT00973479|B1|Baseline|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
942695|NCT00973479|P2|Participant Flow|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
942696|NCT00973479|P1|Participant Flow|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
942697|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
942698|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
942699|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
942737|NCT00973349|B3|Baseline|7.5_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
942738|NCT00973349|B2|Baseline|7.5 w/o MF59 (18 to 64)|1 dose of 7.5 µg A/H1N1 in subjects 18 to 64 years of age
942700|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
942701|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
942702|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
942703|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
942704|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
942705|NCT00973479|O2|Outcome|Group II: Golimumab 2 mg/kg + Methotrexate (MTX)|Participants randomized to receive 2 mg/kg of Golimumab intravenously at Weeks 0, 4, and q8 weeks up to Week 100. Participants will be maintained on their stable dose of commercial MTX (between 15 and 25 mg/week) throughout the study. Participants will receive a placebo infusion at Week 16 and Week 24 to maintain the blind.
942761|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942762|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942763|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942764|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942706|NCT00973479|O1|Outcome|Group I: Placebo + Methotrexate (MTX)|Participants randomized to receive their stable dose of commercial MTX (between 15-25 mg/week) and placebo IV infusions at Weeks 0, 4, 12, 16, and 20. Participants will be crossed over to Golimumab 2 mg/kg at Week 24, and receive administrations at Weeks 24, 28 and q8 weeks thereafter up to Week 100. Subjects randomized to Group I (Placebo + MTX) will have the opportunity to enter early escape at Week 16 and initiate Golimumab 2 mg/kg infusions (Weeks 16, 20, and q8 weeks up to Week 100) if they demonstrate a < 10% improvement in both tender and swollen joint count.
942707|NCT00973479|E4|Reported Event|Combined Golimumab|Participants in the reporting groups: Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16, Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24, and Golimumab 2 mg/kg + MTX.
942708|NCT00973479|E3|Reported Event|Golimumab 2 mg/kg + MTX|Participants were assigned to Golimumab 2 mg/kg + MTX and received at least one 2 mg/kg Golimumab. The follow-up period for this treatment group begins with the first dose of Golimumab 2 mg/kg. Participants may have missed one or more Golimumab doses.
942709|NCT00973479|E2|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 24|Participants received placebo only through Week 24 or subjects who received first placebo and later inadvertently received Golimumab after Week 16 through Week 24. The follow-up period for this treatment group begins once a participants switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
942710|NCT00973479|E1|Reported Event|Placebo + MTX -> Golimumab 2 mg/kg + MTX at Week 16|Participants received placebo only through Week 16 and met early escape criteria or subjects who received first placebo and later inadvertently received Golimumab prior or at Week 16. The follow-up period for this treatment group begins once a participant switches to Golimumab 2 mg/kg. Participants may have missed one or more study agent doses.
942711|NCT00973362|B3|Baseline|Total|Total of all reporting groups
942712|NCT00973362|B2|Baseline|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
942713|NCT00973362|B1|Baseline|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
951448|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
942714|NCT00973362|P2|Participant Flow|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44).~There is no follow-up period for the ASC-US Arm of the study, only for the Adjunct ARM has a three (3) year follow-up period."
942715|NCT00973362|P1|Participant Flow|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
942716|NCT00973362|O1|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
942717|NCT00973362|O2|Outcome|FDA-Approved HPV DNA Test|FDA-Approved HPV DNA Test as Comparator
942718|NCT00973362|O1|Outcome|APTIMA HPV Assay|APTIMA HPV Assay Performed on the Tigris System
942719|NCT00973362|O1|Outcome|FDA-Approved DNA Test|A FDA-Approved HPV DNA Test is the comparator assay,
942720|NCT00973362|O1|Outcome|APTIMA HPV Assay|"The Adjunct study will evaluate APTIMA HPV Assay clinical performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
942765|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942766|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942767|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
951315|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
942721|NCT00973362|E2|Reported Event|ASC-US|"The ASC-US study will determine the sensitivity and specificity of the APTIMA HPV Assay for detecting high-risk HPV types in subjects with ASC-US Pap test results from routine Pap testing and known cervical disease status (based on colposcopic biopsy results).~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
942722|NCT00973362|E1|Reported Event|Adjunct (i.e. Normal Pap)|"The Adjunct study will evaluate APTIMA HPV Assay performance for detecting high-risk HPV types in female subjects 30+ years of age with negative (NILM) cytology results from routine Pap testing. This will be accomplished by evaluating the assay performance compared to known cervical disease status at baseline and after a 3-year follow-up period.~APTIMA HPV Assay: The APTIMA HPV Assay is an in vitro nucleic acid amplification test (NAAT) that qualitatively detects human papillomavirus (HPV) E6/E7 messenger RNA (mRNA) from 14 HPV types (types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) that are associated with cervical cancer (high-risk types). The assay cannot determine the specific high-risk HPV type(s) present and does not cross-react with 5 HPV types that are considered non-oncogenic (not associated with cervical cancer; types 6, 11, 42, 43, and 44)."
942723|NCT00973349|B17|Baseline|Total|Total of all reporting groups
942724|NCT00973349|B16|Baseline|30 w/o MF59 (≥ 65)|1 dose of 30 µg A/H1N1 in subjects ≥ 65 years of age
942725|NCT00973349|B15|Baseline|15_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
942726|NCT00973349|B14|Baseline|15_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects ≥ 65 years of age
942727|NCT00973349|B13|Baseline|15 w/o MF59 (≥ 65)|1 dose of 15 µg A/H1N1 in subjects ≥ 65 years of age
942728|NCT00973349|B12|Baseline|7.5_(100)MF59 (≥ 65)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
942729|NCT00973349|B11|Baseline|7.5_(50)MF59 (≥ 65)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects ≥ 65 years of age
942730|NCT00973349|B10|Baseline|7.5 w/o MF59 (≥ 65)|1 dose of 7.5 µg A/H1N1 in subjects ≥ 65 years of age
942731|NCT00973349|B9|Baseline|3.75_(50)MF59 (≥ 65 )|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects ≥ 65 years of age
942732|NCT00973349|B8|Baseline|30 w/o MF59 (18 to 64)|1 dose of 30 µg A/H1N1 in subjects 18 to 64 years of age
942733|NCT00973349|B7|Baseline|15_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen
942734|NCT00973349|B6|Baseline|15_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen in subjects 18 to 64 years of age
942735|NCT00973349|B5|Baseline|15 w/o MF59 (18 to 64)|1 dose of 15 µg A/H1N1 in subjects 18 to 64 years of age
942736|NCT00973349|B4|Baseline|7.5_(100)MF59 (18 to 64)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen in subjects 18 to 64 years of age
942796|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942739|NCT00973349|B1|Baseline|3.75_(50)MF59 (18 to 64)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen in subjects 18 to 64 years of age
942740|NCT00973349|P16|Participant Flow|30 w/o MF59(≥ 65 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942741|NCT00973349|P15|Participant Flow|15_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942742|NCT00973349|P14|Participant Flow|15_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942743|NCT00973349|P13|Participant Flow|15 w/o MF59 (≥ 65 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942744|NCT00973349|P12|Participant Flow|7.5_(100)MF59 (≥ 65 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942745|NCT00973349|P11|Participant Flow|7.5_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942746|NCT00973349|P10|Participant Flow|7.5 w/o MF59 (≥ 65 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942747|NCT00973349|P9|Participant Flow|3.75_(50)MF59 (≥ 65 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942748|NCT00973349|P8|Participant Flow|30 w/o MF59(18-64 Years)|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942749|NCT00973349|P7|Participant Flow|15_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942750|NCT00973349|P6|Participant Flow|15_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942751|NCT00973349|P5|Participant Flow|15 w/o MF59 (18-64 Years)|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942752|NCT00973349|P4|Participant Flow|7.5_(100)MF59 (18-64 Years)|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942753|NCT00973349|P3|Participant Flow|7.5_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942754|NCT00973349|P2|Participant Flow|7.5 w/o MF59 (18-64 Years)|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942755|NCT00973349|P1|Participant Flow|3.75_(50)MF59 (18-64 Years)|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942756|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942757|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942758|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942759|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942760|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942922|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942768|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942769|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942770|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942771|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942772|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942773|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942774|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942775|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942776|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942777|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942778|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942779|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942780|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942781|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942782|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942783|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942784|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942785|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942786|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942787|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942788|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942789|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942790|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942791|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942792|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942793|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942794|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942795|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942797|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942798|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942799|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942800|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942801|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942802|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942803|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942804|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942805|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942806|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942807|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942808|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942809|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942810|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942811|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942812|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942813|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942814|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942815|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942816|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942817|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942818|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942819|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942820|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
951316|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
942821|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942822|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942823|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942824|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942825|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942826|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942827|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942828|NCT00973349|O8|Outcome|30 w/o MF59|1 dose of 30 µg A/H1N1 administered on study day 1 and day 22
942829|NCT00973349|O7|Outcome|15_(100)MF59|100% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942830|NCT00973349|O6|Outcome|15_(50)MF59|50% of MF59 (an adjuvant) with 15 µg A/H1N1 antigen administered on study day 1 and day 22
942831|NCT00973349|O5|Outcome|15 w/o MF59|1 dose of 15 µg A/H1N1 administered on study day 1 and day 22
942832|NCT00973349|O4|Outcome|7.5_(100)MF59|100% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942833|NCT00973349|O3|Outcome|7.5_(50)MF59|50% of MF59 (an adjuvant) with 7.5 µg A/H1N1 antigen administered on study day 1 and day 22
942834|NCT00973349|O2|Outcome|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1 administered on study day 1 and day 22
942835|NCT00973349|O1|Outcome|3.75_(50)MF59|50% of MF59 (an adjuvant) with 3.75 µg A/H1N1 antigen administered on day 1 and day 22
942836|NCT00973349|E16|Reported Event|30 w/o MF59 (≥65 Yrs)|1 dose of 30 µg A/H1N1
942837|NCT00973349|E15|Reported Event|15_(100)MF59 (≥65 Yrs)|100% of MF59 with 15 µg A/H1N1 antigen
942838|NCT00973349|E14|Reported Event|15_(50)MF59 (≥65 Yrs)|50% of MF59 with 15 µg A/H1N1 antigen
942839|NCT00973349|E13|Reported Event|15 w/o MF59 (≥ 65 Yrs)|1 dose of 15 µg A/H1N1
942840|NCT00973349|E12|Reported Event|7.5_(100)MF59 (≥65 Yrs)|100% of MF59 with 7.5 µg A/H1N1 antigen
942841|NCT00973349|E11|Reported Event|7.5_(50)MF59 (≥65 Yrs)|50% of MF59 with 7.5 µg A/H1N1 antigen
942842|NCT00973349|E10|Reported Event|7.5 w/o MF59 (≥65 Yrs)|1 dose of 7.5 µg A/H1N1
942843|NCT00973349|E9|Reported Event|3.75_(50)MF59 (Above 65 Yrs)|50% of MF59 with the lowest amount of A/H1N1 antigen
942844|NCT00973349|E8|Reported Event|30 w/o MF59|1 dose of 30 µg A/H1N1
942845|NCT00973349|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942846|NCT00973349|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942847|NCT00973349|E5|Reported Event|15 w/o MF59|1 dose of 15 µg A/H1N1
942848|NCT00973349|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942849|NCT00973349|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942850|NCT00973349|E2|Reported Event|7.5 w/o MF59|1 dose of 7.5 µg A/H1N1
942851|NCT00973349|E1|Reported Event|3.75_(50)MF59|50% of MF59 with the lowest amount of A/H1N1 antigen
942880|NCT00972816|P4|Participant Flow|7.5_(100)MF59|7.5 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
942852|NCT00972959|B1|Baseline|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942853|NCT00972959|P1|Participant Flow|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942854|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942855|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942923|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942924|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942925|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942926|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942856|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942857|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942858|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942859|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942881|NCT00972816|P3|Participant Flow|7.5_(50)MF59|7.5 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
942882|NCT00972816|P2|Participant Flow|7.5_(0) MF59|7.5 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
942883|NCT00972816|P1|Participant Flow|3.75_(50) MF59|3.75 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
942884|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942885|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942860|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942861|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942862|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942863|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942864|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942927|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942928|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942929|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942865|NCT00972959|O1|Outcome|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942866|NCT00972959|E1|Reported Event|Bortezomib/Dexamethasone/Zoledronic Acid|"For this study, Velcade will be administered at the standard dose of 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle.~Dexamethasone will be administered at a dose of 12 mg/m2 p.o., on days 1-2, 4-5, 8-9 and 11-12 of the same cycle.~Zoledronic acid will be administered at a dose of 4 mg, iv (15-minute infusion), every 28 days for up to 8 cycles, and then every 28 days for the next 18 months~Bortezomib: 1.3 mg/m2, iv, bolus, on days 1, 4, 8 and 11 of a 21-day cycle for up to 8 chemotherapy cycles~Zoledronic Acid: 4 mg, iv, at a 15 min infusion, Day 1 of every cycle for up to 8 cycles, and then every 28 days for the next 18 months~Dexamethasone: 12 mg/m2 p.o. on days 1-2, 4-5, 8-9 and 11-12 of a 21-day cycle for up to 8 chemotherapy cycles"
942867|NCT00972816|B9|Baseline|Total|Total of all reporting groups
942868|NCT00972816|B8|Baseline|30 Without MF59|1 dose of 30 µg A/H1N1
942869|NCT00972816|B7|Baseline|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942870|NCT00972816|B6|Baseline|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942871|NCT00972816|B5|Baseline|15 Without MF59|1 dose of 15 µg A/H1N1
942872|NCT00972816|B4|Baseline|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942873|NCT00972816|B3|Baseline|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942874|NCT00972816|B2|Baseline|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942875|NCT00972816|B1|Baseline|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942876|NCT00972816|P8|Participant Flow|30_(0) MF59|30 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
942877|NCT00972816|P7|Participant Flow|15_(100) MF59|15 μg A/H1N1 antigen with 100% MF59 adjuvant administered on study day 1 and day 22
942878|NCT00972816|P6|Participant Flow|15_(50) MF59|15 μg A/H1N1 antigen with 50% MF59 adjuvant administered on study day 1 and day 22
942879|NCT00972816|P5|Participant Flow|15_(0) MF59|15 μg A/H1N1 antigen without MF59 adjuvant administered on study day 1 and day 22
942886|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942888|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942889|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942890|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942891|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942892|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942893|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942894|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942895|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942896|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942897|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942898|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942899|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942900|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942901|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942902|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942903|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942904|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942905|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942906|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942907|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942908|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942909|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942910|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942911|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942912|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942913|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942914|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942915|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942916|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942917|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942918|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942919|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942920|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942921|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942931|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942932|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942933|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942934|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942935|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942936|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942937|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942938|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942939|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942940|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942941|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942942|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942943|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942944|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942945|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942946|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942947|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942948|NCT00972816|O8|Outcome|30 Without MF59|1 dose of 30 µg A/H1N1
942949|NCT00972816|O7|Outcome|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942950|NCT00972816|O6|Outcome|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942951|NCT00972816|O5|Outcome|15 Without MF59|1 dose of 15 µg A/H1N1
942952|NCT00972816|O4|Outcome|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942953|NCT00972816|O3|Outcome|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942954|NCT00972816|O2|Outcome|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942955|NCT00972816|O1|Outcome|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942956|NCT00972816|E8|Reported Event|30 Without MF59|1 dose of 30 µg A/H1N1
942957|NCT00972816|E7|Reported Event|15_(100)MF59|100% of MF59 with 15 µg A/H1N1 antigen
942958|NCT00972816|E6|Reported Event|15_(50)MF59|50% of MF59 with 15 µg A/H1N1 antigen
942959|NCT00972816|E5|Reported Event|15 Without MF59|1 dose of 15 µg A/H1N1
942960|NCT00972816|E4|Reported Event|7.5_(100)MF59|100% of MF59 with 7.5 µg A/H1N1 antigen
942961|NCT00972816|E3|Reported Event|7.5_(50)MF59|50% of MF59 with 7.5 µg A/H1N1 antigen
942962|NCT00972816|E2|Reported Event|7.5 Without MF59|1 dose of 7.5 µg A/H1N1
942963|NCT00972816|E1|Reported Event|3.75_(50)MF59|50% of MF59 with 3.75 µg A/H1N1 antigen
942964|NCT00972777|B3|Baseline|Total|Total of all reporting groups
942965|NCT00972777|B2|Baseline|Vehicle|Vehicle of besifloxacin ophthalmic suspension
942966|NCT00972777|B1|Baseline|Besifloxacin|0.6% ophthalmic suspension
942967|NCT00972777|P2|Participant Flow|Vehicle|Vehicle of besifloxacin ophthalmic suspension
942968|NCT00972777|P1|Participant Flow|Besifloxacin|0.6% ophthalmic suspension
942969|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
942970|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
942971|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
942973|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
942974|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
942975|NCT00972777|O2|Outcome|Vehicle|Vehicle of besifloxacin ophthalmic suspension
942976|NCT00972777|O1|Outcome|Besifloxacin|0.6% ophthalmic suspension
942977|NCT00972777|E2|Reported Event|Vehicle|Vehicle of besifloxacin ophthalmic suspension
942978|NCT00972777|E1|Reported Event|Besifloxacin|0.6% ophthalmic suspension
942979|NCT00972738|B4|Baseline|Total|Total of all reporting groups
942980|NCT00972738|B3|Baseline|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942981|NCT00972738|B2|Baseline|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942982|NCT00972738|B1|Baseline|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942983|NCT00972738|P3|Participant Flow|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942984|NCT00972738|P2|Participant Flow|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942985|NCT00972738|P1|Participant Flow|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942986|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942987|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942988|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942989|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942990|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942991|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942992|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942993|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942994|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942995|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942996|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942997|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942998|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
942999|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943000|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943001|NCT00972738|O3|Outcome|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943002|NCT00972738|O2|Outcome|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943003|NCT00972738|O1|Outcome|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943004|NCT00972738|E3|Reported Event|Placebo|Montelukast matching-image placebo tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943005|NCT00972738|E2|Reported Event|Loratadine 10 mg|Loratadine 10 mg compressed tablet and montelukast matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943006|NCT00972738|E1|Reported Event|Montelukast 10 mg|Montelukast 10 mg film-coated tablet and loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
943007|NCT00972725|B3|Baseline|Total|Total of all reporting groups
943008|NCT00972725|B2|Baseline|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943009|NCT00972725|B1|Baseline|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943010|NCT00972725|P2|Participant Flow|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943011|NCT00972725|P1|Participant Flow|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943012|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943013|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943014|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943015|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943016|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943017|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943018|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943019|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943020|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943021|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943022|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943023|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943024|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943025|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943026|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943027|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943028|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943029|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943030|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943031|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943032|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943033|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943034|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943035|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943036|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943037|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943038|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943039|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943040|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943041|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943042|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943043|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943044|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943045|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943046|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943047|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943048|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943049|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943050|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943051|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943052|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943053|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943054|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943055|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943056|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943057|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943058|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943059|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943060|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943061|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943062|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943063|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943064|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943065|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943066|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943067|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943068|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943069|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943070|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943071|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943072|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943073|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943074|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943075|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943076|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943077|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943078|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943079|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943080|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943081|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943082|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943083|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943084|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943085|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943086|NCT00972725|O2|Outcome|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943087|NCT00972725|O1|Outcome|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943088|NCT00972725|E2|Reported Event|GSK732461 Group|Subjects received a booster dose of the GSK732461 vaccine intramuscularly, in the deltoid region of the non-dominant arm.
943089|NCT00972725|E1|Reported Event|GSK732461+Nivaquine Group|Subjects received a single dose of Nivaquine® tablets orally, 2 days prior to receiving a booster dose of the GSK732461 vaccine.
943090|NCT00972621|B3|Baseline|Total|Total of all reporting groups
943091|NCT00972621|B2|Baseline|Viscoat|Currently marketed viscoelastic
943092|NCT00972621|B1|Baseline|Vitrax II|Investigational dispersive viscoelastic
943093|NCT00972621|P2|Participant Flow|Viscoat|Currently marketed viscoelastic
943094|NCT00972621|P1|Participant Flow|Vitrax II|Investigational dispersive viscoelastic
943095|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
943096|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
943097|NCT00972621|O2|Outcome|Viscoat|Viscoat: Control Treatment
943098|NCT00972621|O1|Outcome|Vitrax II|Vitrax II: Investigational Treatment
943099|NCT00972621|E2|Reported Event|Viscoat|Currently marketed viscoelastic
943100|NCT00972621|E1|Reported Event|Vitrax II|Investigational dispersive viscoelastic
943101|NCT00972595|B1|Baseline|All Participants|All Randomized Participants
943102|NCT00972595|P2|Participant Flow|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
943103|NCT00972595|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
943104|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
943105|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
943106|NCT00972595|O2|Outcome|U.K. Tablet|Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
943107|NCT00972595|O1|Outcome|OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
943108|NCT00972595|E2|Reported Event|U.K. Tablet Then OE U.K. Tablet|U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally
943109|NCT00972595|E1|Reported Event|OE U.K. Tablet Then U.K. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
943110|NCT00972543|B3|Baseline|Total|Total of all reporting groups
943111|NCT00972543|B2|Baseline|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943112|NCT00972543|B1|Baseline|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943113|NCT00972543|P2|Participant Flow|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943114|NCT00972543|P1|Participant Flow|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943115|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943116|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943117|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943118|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943119|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943120|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943121|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943122|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943123|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943124|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943125|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943126|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943127|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943128|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943129|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943130|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943131|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943298|NCT00972244|E4|Reported Event|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
943132|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943133|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943134|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943135|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943136|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943137|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943138|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943139|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943140|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943141|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943142|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943143|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943144|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943145|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943430|NCT00971620|E2|Reported Event|Placebo/Saline|Saline intralesional injection
943431|NCT00971620|E1|Reported Event|BTX-A|BTX-A intralesional injection
943146|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943147|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943148|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943149|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943150|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943151|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943152|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943153|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943154|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943155|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943156|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943157|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943158|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943159|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943160|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943161|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943162|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943163|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943164|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943165|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943166|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943167|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943168|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943169|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943170|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943171|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943172|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943173|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943174|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943175|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943176|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943177|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943345|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943178|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943179|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943180|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943181|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943182|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943183|NCT00972543|O2|Outcome|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943184|NCT00972543|O1|Outcome|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943185|NCT00972543|E2|Reported Event|Placebo|Double-blind phase, Placebo for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943186|NCT00972543|E1|Reported Event|Raptiva|Double-blind phase, Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for 12 weeks.There then follows an open label extension of Raptiva 0.7mg/kg followed by Raptiva 1mg/kg/wk for a further 12 weeks
943187|NCT00972530|B3|Baseline|Total|Total of all reporting groups
943188|NCT00972530|B2|Baseline|Immobilisation|48 hours postinjection rest
943189|NCT00972530|B1|Baseline|Activity|Normal activity without restrictions
943190|NCT00972530|P2|Participant Flow|Immobilisation|48 hours postinjection rest
943191|NCT00972530|P1|Participant Flow|Activity|Normal activity without restrictions
943192|NCT00972530|O2|Outcome|Immobilisation|48 hours postinjection rest
943193|NCT00972530|O1|Outcome|Activity|Normal activity without restrictions
943194|NCT00972530|E2|Reported Event|Immobilisation|48 hours postinjection rest
943195|NCT00972530|E1|Reported Event|Activity|Normal activity without restrictions
943196|NCT00972478|B3|Baseline|Total|Total of all reporting groups
943197|NCT00972478|B2|Baseline|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943198|NCT00972478|B1|Baseline|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943299|NCT00972244|E3|Reported Event|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
943199|NCT00972478|P2|Participant Flow|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943200|NCT00972478|P1|Participant Flow|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943201|NCT00972478|O2|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943202|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943203|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943204|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943205|NCT00972478|O1|Outcome|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943206|NCT00972478|O1|Outcome|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943207|NCT00972478|E2|Reported Event|Ph II: R-CHOP+Vorinostat|Patients receive vorinostat 400 mg PO once daily on days 1-5 or 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943208|NCT00972478|E1|Reported Event|Ph I: R-CHOP+Vorinostat (400mg D1-9)|Patients receive vorinostat 400 mg PO once daily on days 1-9 (according to dose level), rituximab IV, cyclophosphamide IV over 30-60 minutes, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 3. Patients also receive prednisone PO once daily on days 3-7. Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity.
943209|NCT00972374|B4|Baseline|Total|Total of all reporting groups
943210|NCT00972374|B3|Baseline|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
943211|NCT00972374|B2|Baseline|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943212|NCT00972374|B1|Baseline|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943213|NCT00972374|P3|Participant Flow|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
943214|NCT00972374|P2|Participant Flow|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943215|NCT00972374|P1|Participant Flow|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943216|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
943217|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943218|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943219|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
943220|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943221|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943222|NCT00972374|O3|Outcome|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
943223|NCT00972374|O2|Outcome|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943224|NCT00972374|O1|Outcome|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943225|NCT00972374|E3|Reported Event|Sham (no Implant)|Sham Posterior Segment Drug Delivery system on Day 1 in the study eye.
943226|NCT00972374|E2|Reported Event|200 ug Brimonidine Implant|200 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943227|NCT00972374|E1|Reported Event|400 ug Brimonidine Implant|400 ug Brimonidine Tartrate Posterior Segment Drug Delivery system on Day 1 in the study eye.
943300|NCT00972244|E2|Reported Event|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
943228|NCT00972335|B1|Baseline|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
943229|NCT00972335|P1|Participant Flow|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
943230|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
943231|NCT00972335|O1|Outcome|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
943232|NCT00972335|E1|Reported Event|Combination Therapy|"Everolimus; this drug will be dosed at 10 mg orally DAILY for the duration of the study.~Bevacizumab; this drug will be given IV at 10 mg/kg on Days 1 and 15 of each 28-day treatment cycle for the duration of the study"
943233|NCT00972322|B3|Baseline|Total|Total of all reporting groups
943234|NCT00972322|B2|Baseline|Placebo|Placebo to MK-8245, twice daily for 28 days
943235|NCT00972322|B1|Baseline|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
943236|NCT00972322|P2|Participant Flow|Placebo|Placebo to MK-8245, twice daily for 28 days
943237|NCT00972322|P1|Participant Flow|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
943238|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
943239|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
943240|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
943241|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
943242|NCT00972322|O2|Outcome|Placebo|Placebo to MK-8245, twice daily for 28 days
943243|NCT00972322|O1|Outcome|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
943244|NCT00972322|E2|Reported Event|Placebo|Placebo to MK-8245, twice daily for 28 days
943245|NCT00972322|E1|Reported Event|MK-8245 100 mg|MK-8245, 50 mg, twice daily for 28 days
943246|NCT00972283|B3|Baseline|Total|Total of all reporting groups
943247|NCT00972283|B2|Baseline|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943248|NCT00972283|B1|Baseline|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943249|NCT00972283|P2|Participant Flow|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943250|NCT00972283|P1|Participant Flow|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943251|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943252|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943253|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943254|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943255|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943256|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943257|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943258|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943259|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943260|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943261|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943262|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943263|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943264|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943265|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943266|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943267|NCT00972283|O2|Outcome|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943432|NCT00971425|B3|Baseline|Total|Total of all reporting groups
943268|NCT00972283|O1|Outcome|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943269|NCT00972283|E2|Reported Event|IGlar OD|Insulin glargine (IGlar) was given subcutaneously once daily (OD), according to labelling instructions with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. IGlar was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943270|NCT00972283|E1|Reported Event|IDeg OD|Insulin degludec (IDeg) was given subcutaneously once daily (OD) with main evening meal with insulin aspart (IAsp) as mealtime insulin with or without subject's pre-trial metformin with or without pioglitazone. The regimen was given for a treatment duration of 52 weeks in the main period and for an additional 26 weeks in the extension period.
943271|NCT00972244|B6|Baseline|Total|Total of all reporting groups
943272|NCT00972244|B5|Baseline|Placebo|Placebo Comparator
943273|NCT00972244|B4|Baseline|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
943274|NCT00972244|B3|Baseline|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
943275|NCT00972244|B2|Baseline|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
943276|NCT00972244|B1|Baseline|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
943277|NCT00972244|P5|Participant Flow|Placebo|Placebo Comparator
943278|NCT00972244|P4|Participant Flow|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
943279|NCT00972244|P3|Participant Flow|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
943280|NCT00972244|P2|Participant Flow|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
943281|NCT00972244|P1|Participant Flow|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
943282|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
943283|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
943284|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
943285|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
943286|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
943287|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
943288|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
943289|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
943290|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
943291|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
943292|NCT00972244|O5|Outcome|Placebo|Placebo Comparator
943293|NCT00972244|O4|Outcome|10mg Dapagliflozin|Dapagliflozin tablet 10 mg once daily
943294|NCT00972244|O3|Outcome|5mg Dapagliflozin|Dapagliflozin tablet 5 mg once daily
943295|NCT00972244|O2|Outcome|2.5mg Dapagliflozin|Dapagliflozin tablet 2.5 mg once daily
943296|NCT00972244|O1|Outcome|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
943297|NCT00972244|E5|Reported Event|Placebo|Placebo Comparator
943301|NCT00972244|E1|Reported Event|1mg Dapagliflozin|Dapagliflozin tablet 1 mg once daily
943302|NCT00972205|B1|Baseline|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
943303|NCT00972205|P1|Participant Flow|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
943304|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
943305|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
943306|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
943307|NCT00972205|O1|Outcome|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
943346|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943347|NCT00971997|O3|Outcome|Lispro 50/50 Three Times Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943308|NCT00972205|E1|Reported Event|Paclitaxel and CBT-1 to Treat Solid Tumors|"Patients will be treated with oral CBT-1 at a dose of 500 mg/m^2 daily for 7 days in divided doses and repeated every 21 days for 7 days beginning with cycle 1 of each cycle provided cycles are not delayed.~Paclitaxel will be 135 mg/m^2 intravenously on day 6 over 180 minutes. Cycles are repeated every 21 days provided there is no delay, and will be administered on day 6 of each cycle."
943309|NCT00972153|B4|Baseline|Total|Total of all reporting groups
943310|NCT00972153|B3|Baseline|Device Deployed and Activated|
943311|NCT00972153|B2|Baseline|Device Attached, Not Activated|
943312|NCT00972153|B1|Baseline|No Device Used|
943313|NCT00972153|P3|Participant Flow|Device Deployed and Activated|
943314|NCT00972153|P2|Participant Flow|Device Attached, Not Activated|
943315|NCT00972153|P1|Participant Flow|No Device Used|
943316|NCT00972153|O3|Outcome|Device Deployed and Activated|
943317|NCT00972153|O2|Outcome|Device Attached, Not Activated|
943318|NCT00972153|O1|Outcome|No Device Used|
943319|NCT00972153|O3|Outcome|Device Deployed and Activated|
943320|NCT00972153|O2|Outcome|Device Attached, Not Activated|
943321|NCT00972153|O1|Outcome|No Device Used|
943322|NCT00972153|E3|Reported Event|Device Deployed and Activated|
943323|NCT00972153|E2|Reported Event|Device Attached, Not Activated|
943324|NCT00972153|E1|Reported Event|No Device Used|
943325|NCT00972088|B1|Baseline|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
943326|NCT00972088|P1|Participant Flow|a Single Arm Group, Patients With Ano Rectal Disease|patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease
943327|NCT00972088|O1|Outcome|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
943328|NCT00972088|E1|Reported Event|Anorectal Disease, Negative Work up for Crohns Disease|Patients presently suffering from anorectal abscess or anorectal fistula
943329|NCT00972023|B1|Baseline|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
943330|NCT00972023|P1|Participant Flow|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
943331|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
943391|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
943392|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
943332|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"DHEA, surgical resection:~Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: Administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
943333|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA: DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection: Surgical procedure of the invasive breast cancer"
943334|NCT00972023|O1|Outcome|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
943335|NCT00972023|E1|Reported Event|DHEA, Surgical Resection|"Day-14 (approx. 2 wks prior to surgery): begin a 2 week course of DHEA; Day-7 (approx. 1 wk after starting treatment): answer question about pill diary; Day 0 (approx. 2 wks after starting treatment, within 48 hours prior to surgery;~DHEA : DHEA administration will begin approxiately 14 days prior to surgery.~Surgical resection : Surgical procedure of the invasive breast cancer"
943336|NCT00971997|B1|Baseline|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943337|NCT00971997|P1|Participant Flow|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943338|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943339|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943340|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943341|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943342|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943343|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943344|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
951317|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
943348|NCT00971997|O2|Outcome|Lispro 50/50 Twice Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943349|NCT00971997|O1|Outcome|Lispro 50/50 Once Daily|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943350|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943351|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943352|NCT00971997|O1|Outcome|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943353|NCT00971997|E1|Reported Event|Lispro 50/50|Administered subcutaneously once daily for 16 weeks, twice daily for 16 weeks, and three times daily for 16 weeks dependent on glycemic control
943354|NCT00971932|B1|Baseline|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943355|NCT00971932|P1|Participant Flow|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943356|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943357|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943358|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943359|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943360|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943426|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943427|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943428|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943361|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943362|NCT00971932|O1|Outcome|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943363|NCT00971932|E1|Reported Event|Cetuximab + Cisplatin/Carboplatin + 5-Fluorouracil (5-FU)|Participants were administered an initial dose of cetuximab 400 milligram per square meter (mg/m^2) intravenous (IV) infusion over 120 minutes followed by subsequent weekly doses of 250 mg/m^2 IV infusion over 60 minutes along with background chemotherapy consisting of cisplatin 100 mg/m^2 IV infusion over 60 to 120 minutes on day 1 of each 3-week treatment cycle and 5-fluorouracil (5-FU) 1000 mg/m^2 per day as a continuous IV infusion over 24 hours from day 1 to day 4 of each 3-week treatment cycle, for up to 6 cycles in the absence of progressive disease (PD) or unacceptable toxicity. If participant developed non-hematological toxicities to cisplatin, carboplatin (area under curve 5 [AUC5]) was administered as IV infusion over 60 to 120 minutes on Day 1 of each 3-week treatment cycle.
943364|NCT00971841|B1|Baseline|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original Study CA139-540 (NCT 00344552)and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest. One treatment course consisted of 49 days total.
943365|NCT00971841|P1|Participant Flow|Paclitaxel|Paclitaxel dosed at the same dose level as last dose received in original study (100 mg/m^2, 80 mg/m^2, or 60 mg/m^2) and administered on Days 1, 8, 15, 22, 29, 36, followed by 1 week of rest (6 weeks on, 1 week off). One treatment course consisted of 49 days total.
943366|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
943367|NCT00971841|O1|Outcome|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
943368|NCT00971841|E1|Reported Event|Paclitaxel|Paclitaxel dosed weekly (6 weeks on, 1 week off).
943393|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
943597|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
943369|NCT00971789|B1|Baseline|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
943370|NCT00971789|P1|Participant Flow|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
943371|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
943372|NCT00971789|O1|Outcome|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
943373|NCT00971789|E1|Reported Event|Sirolimus Patients|sirolimus 6 mg by mouth loading dose and 2 mg by mouth daily in a 28 day treatment cycle. Patients who do not have cancer take the drug for a total of two cycles (56 days) unless they develop unacceptable side effects. Those who have cancer may continue sirolimus beyond cycle 2 until their disease worsens or they develop unacceptable side effects.
943374|NCT00971750|B1|Baseline|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
943375|NCT00971750|P1|Participant Flow|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
943376|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
943377|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
943378|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively during gastric bypass
943379|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
943380|NCT00971750|O2|Outcome|Laparoscopic Ultrasound|Laparoscopic ultrasound is performed intraoperatively at the time of gastric bypass.
943381|NCT00971750|O1|Outcome|Transabdominal Ultrasound|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
943382|NCT00971750|E1|Reported Event|Ultrasound Study Group|Patients with no history of gallbladder surgery who are undergoing elective laparoscopic roux-en-Y gastric bypass that have consented to undergo a preoperative transabdominal ultrasound in addition to routine preoperative assessment for surgery.
943383|NCT00971633|B1|Baseline|All Participants|All randomized participants
943384|NCT00971633|P6|Participant Flow|U.S. Tablet Then U.K. Tablet Then OE U.K. Tablet|U.S. tablet then U.K. tablet then OE U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally
943385|NCT00971633|P5|Participant Flow|U.K. Tablet Then OE U.K. Tablet Then U.S. Tablet|U.K. tablet then OE U.K. tablet then U.S. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
943386|NCT00971633|P4|Participant Flow|OE U.K. Tablet Then U.S. Tablet Then U.K. Tablet|OE U.K. tablet then U.S. tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally/Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
943387|NCT00971633|P3|Participant Flow|U.S. Tablet Then OE U.K. Tablet Then U.K. Tablet|U.S. tablet then OE U.K. tablet then U.K. tablet: Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K ZOFRAN (ondansetron) taken orally/Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally
943388|NCT00971633|P2|Participant Flow|U.K. Tablet Then U.S. Tablet Then OE U.K. Tablet|U.K. tablet then U.S. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.K. taken orally /Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of U.K. ZOFRAN (ondansetron) taken orally.
943389|NCT00971633|P1|Participant Flow|OE U.K. Tablet Then U.K. Tablet Then U.S. Tablet|Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet then United States (U.S.) tablet: Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally./Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally./Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the U.S. taken orally
943390|NCT00971633|O3|Outcome|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
943394|NCT00971633|O2|Outcome|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
943395|NCT00971633|O1|Outcome|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
943396|NCT00971633|E3|Reported Event|Treatment U.S. Tablet|Treatment U.S. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United States (U.S.) taken orally
943397|NCT00971633|E2|Reported Event|Treatment U.K. Tablet|Treatment U.K. tablet: a single 8-mg tablet of ZOFRAN (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally
943398|NCT00971633|E1|Reported Event|Treatment OE U.K. Tablet|Treatment OE U.K. tablet: an over-encapsulated single 8-mg tablet of United Kingdom (U.K.) ZOFRAN (ondansetron) taken orally
943399|NCT00971620|B3|Baseline|Total|Total of all reporting groups
943400|NCT00971620|B2|Baseline|Placebo/Saline|Saline intralesional injection
943401|NCT00971620|B1|Baseline|BTX-A|BTX-A intralesional injection
943402|NCT00971620|P2|Participant Flow|Placebo/Saline|Saline intralesional injection
943403|NCT00971620|P1|Participant Flow|BTX-A|BTX-A intralesional injection
943404|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943405|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943406|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943407|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943408|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943409|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943410|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943411|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943412|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943413|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943414|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943415|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943416|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943417|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943418|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943419|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943420|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943421|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943422|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943423|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943424|NCT00971620|O2|Outcome|Placebo/Saline|Saline intralesional injection
943425|NCT00971620|O1|Outcome|BTX-A|BTX-A intralesional injection
943433|NCT00971425|B2|Baseline|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943434|NCT00971425|B1|Baseline|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943435|NCT00971425|P2|Participant Flow|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943436|NCT00971425|P1|Participant Flow|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943437|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943438|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943439|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943440|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943441|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943442|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943443|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
951449|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
943444|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943445|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943446|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943447|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943448|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943449|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943450|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943451|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943452|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943453|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943454|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943455|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943456|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943457|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943458|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943459|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943460|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943461|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943462|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943463|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943464|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943465|NCT00971425|O2|Outcome|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943466|NCT00971425|O1|Outcome|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943467|NCT00971425|E2|Reported Event|Fluarix-Pandemrix-Placebo Group|Subjects received 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid of the non-dominant arm at Day 0 and 21, and 1 dose of placebo intramuscularly in the deltoid of the non-dominant arm at Day 42.
943468|NCT00971425|E1|Reported Event|Placebo-Pandemrix-Fluarix Group|Subjects received one dose of placebo intramuscularly in the deltoid region of the dominant arm at Day -21, 2 doses of Pandemrix intramuscularly in the deltoid region of the non-dominant arm at Day 0 and Day 21, and 1 dose of Fluarix intramuscularly in the deltoid region of the dominant arm at Day 42.
943469|NCT00971295|B1|Baseline|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
943470|NCT00971295|P2|Participant Flow|Treatment Sequence B|"Treatment Sequence B:~Metformin period followed by washout period followed by Metformin + Eslicarbazepine acetate~850 mg metformin hydrochloride, 1200 mg ESL"
943471|NCT00971295|P1|Participant Flow|Treatment Sequence A|"Treatment Sequence A:~Eslicarbazepine acetate + Metformin period followed by washout period followed by Metformin period~850 mg metformin hydrochloride, 1200 mg ESL"
943472|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
943473|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
943474|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
943475|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
943476|NCT00971295|O2|Outcome|Metformin|Metformin HCl 850 mg
943477|NCT00971295|O1|Outcome|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
943478|NCT00971295|E2|Reported Event|Metformin|Metformin HCl 850 mg
943479|NCT00971295|E1|Reported Event|Metformin + ESL|"Metformin HCl 850 mg, ESL 1200 mg~Metformin + eslicarbazepine: 850 mg metformin hydrochloride, once as oral single-dose and once after pre-treatment with once-daily dose of ESL 1200 mg for 6 days"
943480|NCT00971282|B1|Baseline|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
943481|NCT00971282|P1|Participant Flow|Intra-individual Comparison|Differin applied once daily (evening) on the whole face Cetaphil applied once daily (morning) on 1 side of the face
943482|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
943483|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
943484|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
943485|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
943486|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
943487|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
943488|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
943489|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
943490|NCT00971282|O2|Outcome|Differin Alone|Differin applied once daily (evening)
943491|NCT00971282|O1|Outcome|Cetaphil + Differin|Differin applied once daily (evening) Cetaphil applied once daily (morning)
943492|NCT00971282|E2|Reported Event|Differin Alone|intra-individual comparison
943493|NCT00971282|E1|Reported Event|Cetaphil + Differin|intra-individual comparison
943494|NCT00971243|B6|Baseline|Total|Total of all reporting groups
943495|NCT00971243|B5|Baseline|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943496|NCT00971243|B4|Baseline|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943497|NCT00971243|B3|Baseline|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943498|NCT00971243|B2|Baseline|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943499|NCT00971243|B1|Baseline|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943500|NCT00971243|P5|Participant Flow|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943501|NCT00971243|P4|Participant Flow|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943502|NCT00971243|P3|Participant Flow|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943503|NCT00971243|P2|Participant Flow|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943598|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
943504|NCT00971243|P1|Participant Flow|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943505|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943506|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943507|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943508|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943509|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943510|NCT00971243|O5|Outcome|Placebo+Met|Placebo for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943511|NCT00971243|O4|Outcome|Teneli 40mg+Met|Teneligliptin 40mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943512|NCT00971243|O3|Outcome|Teneli 20mg+Met|Teneligliptin 20mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943513|NCT00971243|O2|Outcome|Teneli 10mg+Met|Teneligliptin 10mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943514|NCT00971243|O1|Outcome|Teneli 5mg+Met|Teneligliptin 5mg for 24 weeks (double-blind period) followed by teneligliptin20 mg for additional 28 weeks (open-label period) in combination with Metformin
943515|NCT00971243|E5|Reported Event|Placebo+Met|Placebo plus Metformin
943516|NCT00971243|E4|Reported Event|Teneli 40 mg+Met|Teneligliptin 40mg plus Metformin
943517|NCT00971243|E3|Reported Event|Teneli 20 mg+Met|Teneligliptin 20mg plus Metformin
943518|NCT00971243|E2|Reported Event|Teneli 10 mg+Met|Teneligliptin 10mg plus Metformin
943519|NCT00971243|E1|Reported Event|Teneli 5mg+Met|Teneligliptin 5mg plus Metformin
943520|NCT00971204|B1|Baseline|Treatment With HeartLight|Treatment of PAF with HeartLight System PVI ablation
943521|NCT00971204|P1|Participant Flow|Treatment With EAS-AC|"Treatment of PAF with EAS-AC~CardioFocus Endoscopic Ablation System - Adaptive Contact (EAS-AC): PVI ablation"
943522|NCT00971204|O1|Outcome|Treatment With HeartLight|"Treatment of PAF with HeartLight System~CardioFocus HeartLight Endoscopic Ablation System: PVI ablation"
943523|NCT00971204|E1|Reported Event|Treatment With HeartLight|Treatment of PAF with HeartLight
943524|NCT00971048|B5|Baseline|Total|Total of all reporting groups
951318|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
943525|NCT00971048|B4|Baseline|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
943526|NCT00971048|B3|Baseline|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
943527|NCT00971048|B2|Baseline|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
943528|NCT00971048|B1|Baseline|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
943529|NCT00971048|P4|Participant Flow|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
943530|NCT00971048|P3|Participant Flow|HP828-101 Treating PU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had pressure ulcers (PU)
943531|NCT00971048|P2|Participant Flow|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU (3M Tegaderm Hydrogel)"
943532|NCT00971048|P1|Participant Flow|HP828-101 Treating DFU|HP828-101 : Topical test article approximately the size of a nickel, applied once daily Treatment group had diabetic foot ulcers (DFU)
943533|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
943534|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
943535|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
943536|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
943537|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
943538|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had pressure ulcers (PU)
943539|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
943540|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied approximately the size of a nickel, once daily Treatment group had diabetic foot ulcers (DFU)
943541|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
943542|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
943543|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
943544|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
943545|NCT00971048|O4|Outcome|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
943546|NCT00971048|O3|Outcome|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
943547|NCT00971048|O2|Outcome|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
943548|NCT00971048|O1|Outcome|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
943549|NCT00971048|E4|Reported Event|Standard of Care Treating PU|"For Pressure Ulcers (PU) Standard of Care (SoC) was a hydrocolloid gel~Hydrocolloid for PU: Topical test articles applied once daily (ConvaTec DuoDERM Hydroactive Gel for PU)"
943550|NCT00971048|E3|Reported Event|HP828-101 Treating PU|HP828-101 : Topical test article applied once daily Treatment group had pressure ulcers (PU)
943551|NCT00971048|E2|Reported Event|Standard of Care Treating DFU|"For diabetic foot ulcers (DFU) Standard of Care (SoC) is a hydrogel~Hydrogel for DFU(3M Tegaderm Hydrogel)"
943552|NCT00971048|E1|Reported Event|HP828-101 Treating DFU|HP828-101 : Topical test article applied once daily Treatment group had diabetic foot ulcers (DFU)
943553|NCT00970944|B3|Baseline|Total|Total of all reporting groups
943554|NCT00970944|B2|Baseline|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
943555|NCT00970944|B1|Baseline|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
943556|NCT00970944|P2|Participant Flow|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
943557|NCT00970944|P1|Participant Flow|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
943558|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
943559|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
943560|NCT00970944|O2|Outcome|Placebo|Visually identical compound administered in the same manner (ie enterally) as the study drug.
943561|NCT00970944|O1|Outcome|Amantadine|Amantadine (200-400 mg/day)
943562|NCT00970944|E2|Reported Event|Placebo|Visually identical compound administered in the same manner (ie enterally) as the actual study drug.
943624|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
951319|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
943563|NCT00970944|E1|Reported Event|Amantadine HCL|100mg BID administered for 2 weeks, then increased to 150mg BID in week 3 if change on primary outcome measure (ie Disability Rating Scale, DRS) was less than 2 points after week 2. If change in DRS score remained less than 2 points after week 3, dose was increased to 200mg BID in week 4.
943564|NCT00970853|B3|Baseline|Total|Total of all reporting groups
943565|NCT00970853|B2|Baseline|MOM Program Home Visiting|Mixed professional support home visiting program.
943566|NCT00970853|B1|Baseline|Control|Control group
943567|NCT00970853|P2|Participant Flow|MOM Program Home Visiting|Mixed professional support home visiting program.
943568|NCT00970853|P1|Participant Flow|Control|Control group
943569|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943570|NCT00970853|O1|Outcome|Control|Control group
943571|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943572|NCT00970853|O1|Outcome|Control|Control group
943573|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943574|NCT00970853|O1|Outcome|Control|Control group
943575|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943576|NCT00970853|O1|Outcome|Control|Control group
943577|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943578|NCT00970853|O1|Outcome|Control|Control group
943579|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943580|NCT00970853|O1|Outcome|Control|Control group
943581|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943582|NCT00970853|O1|Outcome|Control|Control group
943583|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943584|NCT00970853|O1|Outcome|Control|Control group
943585|NCT00970853|O2|Outcome|MOM Program Home Visiting|Mixed professional support home visiting program.
943586|NCT00970853|O1|Outcome|Control|Control group
943587|NCT00970853|E2|Reported Event|MOM Program Home Visiting|Mixed professional support home visiting program.
943588|NCT00970853|E1|Reported Event|Control|Control group
943589|NCT00970814|B3|Baseline|Total|Total of all reporting groups
943590|NCT00970814|B2|Baseline|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
943591|NCT00970814|B1|Baseline|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
943592|NCT00970814|P2|Participant Flow|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
943593|NCT00970814|P1|Participant Flow|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
943594|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
943595|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
943596|NCT00970814|O2|Outcome|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
943599|NCT00970814|O1|Outcome|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
943600|NCT00970814|E2|Reported Event|Levetiracetam and BBCET|Levetiracetam and Brief Behavioral Therapy
943601|NCT00970814|E1|Reported Event|Sugar Pill and BBCET|Placebo and Brief Behavioral Compliance Enhancement Therapy
943602|NCT00970736|B1|Baseline|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
943603|NCT00970736|P1|Participant Flow|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
943604|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
943605|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
943606|NCT00970736|O1|Outcome|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
943607|NCT00970736|E1|Reported Event|Healthy Participants|20 healthy participants between 60 and 80 years of age. Ten men and 10 women.
943608|NCT00970684|B1|Baseline|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
943609|NCT00970684|P1|Participant Flow|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
943610|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
943611|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
943612|NCT00970684|O1|Outcome|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
943613|NCT00970684|E1|Reported Event|Bevacizumab, Docetaxel, and Gemcitabine|Treatment repeats every 21 days for up to 6 courses.
943614|NCT00970632|B4|Baseline|Total|Total of all reporting groups
943615|NCT00970632|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943616|NCT00970632|B2|Baseline|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943617|NCT00970632|B1|Baseline|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943618|NCT00970632|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943619|NCT00970632|P2|Participant Flow|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943620|NCT00970632|P1|Participant Flow|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943621|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943622|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943623|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943625|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943626|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943627|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943628|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943629|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943630|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943631|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943632|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943633|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943634|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943635|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943636|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943637|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943638|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943639|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943640|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943641|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943642|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943643|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943644|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943645|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943646|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943647|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943648|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943649|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943650|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943651|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943652|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943653|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943654|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943655|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943656|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943657|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943658|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943659|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943660|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943661|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943662|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943663|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943664|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943665|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943666|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943667|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943668|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943669|NCT00970632|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943670|NCT00970632|O2|Outcome|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943671|NCT00970632|O1|Outcome|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943672|NCT00970632|E3|Reported Event|Placebo|Placebo tablet orally (po) once daily (QD) and placebo capsule po QD for 12 weeks
943673|NCT00970632|E2|Reported Event|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg capsule po QD and placebo tablet po QD for 12 weeks
943674|NCT00970632|E1|Reported Event|Tadalafil 5 mg|Tadalafil 5 milligram (mg) tablet po QD and placebo capsule po QD for 12 weeks
943675|NCT00970606|B3|Baseline|Total|Total of all reporting groups
943676|NCT00970606|B2|Baseline|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
943677|NCT00970606|B1|Baseline|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
944902|NCT00966264|E1|Reported Event|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
943678|NCT00970606|P2|Participant Flow|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
943679|NCT00970606|P1|Participant Flow|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
943680|NCT00970606|O2|Outcome|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
943681|NCT00970606|O1|Outcome|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
943682|NCT00970606|E2|Reported Event|Rosuvastatin (Crestor)|"Experimental arm~Rosuvastatin (crestor) : 20 mg tablets once daily x max 28 days or for an additional 3 days following ICU discharge"
943683|NCT00970606|E1|Reported Event|Placebo Tablet|"Placebo~Placebo : Placebo tablet identical to active therapy. 1 tablet per day"
943684|NCT00970502|B1|Baseline|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
943685|NCT00970502|P1|Participant Flow|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
943686|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|Recommended dose of celecoxib was 400mg
943687|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
943688|NCT00970502|O1|Outcome|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
943689|NCT00970502|O3|Outcome|Celecoxib 600mg|Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily
943690|NCT00970502|O2|Outcome|Celecoxib 400mg|Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily
943691|NCT00970502|O1|Outcome|Celecoxib 200mg|Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily
943732|NCT00970320|E3|Reported Event|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943866|NCT00969228|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943692|NCT00970502|E1|Reported Event|Erlotinib + Celecoxib|erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression
943693|NCT00970489|B3|Baseline|Total|Total of all reporting groups
943694|NCT00970489|B2|Baseline|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
943695|NCT00970489|B1|Baseline|Olive Oil Capsule|Placebo : Olive Oil capsules
943696|NCT00970489|P2|Participant Flow|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
943697|NCT00970489|P1|Participant Flow|Olive Oil Capsule|"Placebo : Olive Oil capsules All patients were randomized to receive n-3 Polyunsaturated fatty acids (PUFA) or matched placebo in equal numbers using computer-generated numbers, stratified by medical center.~Treatment: Either oral n-3 PUFA (1 g capsules, each containing ~850 mg of EPA+DHA) or matching placebo (olive oil, 1 g capsules).~Total loading dose = 8 g over 2 to 4 days pre-op, followed by 2 g/d post-op until hospital discharge or until post-op day 10, whichever sooner."
943698|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
943699|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
943700|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
943701|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
943702|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
943703|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
943704|NCT00970489|O2|Outcome|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
943705|NCT00970489|O1|Outcome|Olive Oil Capsule|Placebo : Olive Oil capsules
943706|NCT00970489|E2|Reported Event|Omega-3 Fatty Acid Capsules|Omega -3 fatty acids : 10g dose of oral omega-3 fatty acid capsules over 3-5 days before surgery (or 8 g over 2 days before surgery), including the morning of surgery, followed by 2g/d after surgery for 10 days, or until discharge, whichever occurs first.
943707|NCT00970489|E1|Reported Event|Olive Oil Capsule|Placebo : Olive Oil capsules
943708|NCT00970359|B1|Baseline|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
943709|NCT00970359|P1|Participant Flow|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
943710|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
943733|NCT00970320|E2|Reported Event|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943734|NCT00970320|E1|Reported Event|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943735|NCT00970307|B4|Baseline|Total|Total of all reporting groups
951450|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
943711|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
943712|NCT00970359|O1|Outcome|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
943713|NCT00970359|E1|Reported Event|AZD6244|"AZD6244: Within 1 week of starting the study: Low iodine diet~The patient will receive three bottles of capsules containing the drug AZD6244. Each capsule contains 25 milligrams of AZD6244. They will take 3 capsules orally, by mouth twice a day for 4 weeks. AZD6244 should be taken on an empty stomach (either one hour before or 2 hours after meals). AZD6244 capsules should be taken with water only. Lesional dosimetry with iodine-124 PET will be done twice, at the beginning and at the end of the study. This is done the same way that a radioactive iodine scan is done and is spread out over 5 days. It requires injection with human recombinant TSH (Thyrogen) on day 1 and 2, as well as blood tests on day 1 and day 5. On day 3, you will receive the iodine-124 in form of an oral drink, and the PET scan will be obtained on day 5. You will need to follow a low iodine diet starting 5 days before and throughout the process."
943714|NCT00970320|B6|Baseline|Total|Total of all reporting groups
943715|NCT00970320|B5|Baseline|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
943716|NCT00970320|B4|Baseline|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943717|NCT00970320|B3|Baseline|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943718|NCT00970320|B2|Baseline|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943719|NCT00970320|B1|Baseline|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943720|NCT00970320|P5|Participant Flow|Prevalence Study|1571 primiparas delivering at Ostfold Hospital Trust or St. Olav's Hospital during the period May 2009 to December 2010.
943721|NCT00970320|P4|Participant Flow|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943722|NCT00970320|P3|Participant Flow|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943723|NCT00970320|P2|Participant Flow|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943724|NCT00970320|P1|Participant Flow|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943725|NCT00970320|O5|Outcome|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
943726|NCT00970320|O4|Outcome|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943727|NCT00970320|O3|Outcome|Control Group, RCT3|Women with obsteric anal sphincter injury receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943728|NCT00970320|O2|Outcome|Intervention Group, RCT 2|"Participants reporting anal incontinence 6 months postpartum receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943729|NCT00970320|O1|Outcome|Control Group, RCT2|Participants reporting anal incontinence 6 months postpartum receiving written information only for 6 months. After 6 months they are offered the same intervention as the intervention group, i.e. PFMT for 6 months.
943730|NCT00970320|E5|Reported Event|Prevalence Study|1571 primiparae delivering at Ostfold Hospital Trust or St. Olavs Hospital during the period May 2009 to December 2010.
943731|NCT00970320|E4|Reported Event|Intervention Group, RCT 3|"Women with obsteric anal sphincter injury receiving pelvic floor muscle training (PFMT) for 6 months (+6 months).~Pelvic floor muscle training: 6 months of daily pelvic floor exercise treatment with regular follow up by specialist physiotherapist."
943736|NCT00970307|B3|Baseline|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943737|NCT00970307|B2|Baseline|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943738|NCT00970307|B1|Baseline|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943739|NCT00970307|P3|Participant Flow|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943740|NCT00970307|P2|Participant Flow|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943741|NCT00970307|P1|Participant Flow|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943742|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943826|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943924|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943743|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943744|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943745|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943746|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943747|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943748|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943749|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943847|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
943750|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943751|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943752|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943753|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943754|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943755|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943756|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943757|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943827|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943758|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943759|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943760|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943761|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943762|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943763|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943764|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943765|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943766|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943767|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943768|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943769|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943770|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943771|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943772|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943828|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943773|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943774|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943775|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943776|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943777|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943778|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943779|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943780|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943781|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943782|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943783|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943784|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943785|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943786|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943787|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943829|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943788|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943789|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943790|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943791|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943792|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943793|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943794|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943795|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943796|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943797|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943798|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943799|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943800|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943801|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943802|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943830|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943803|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943804|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943805|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943806|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943807|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943808|NCT00970307|O3|Outcome|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943809|NCT00970307|O2|Outcome|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943810|NCT00970307|O1|Outcome|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943811|NCT00970307|E3|Reported Event|Infanrix Hexa + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943812|NCT00970307|E2|Reported Event|Infanrix Hexa + Menjugate Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of Infanrix hexa™ vaccine at 2, 3 and 4 months of age, 2 doses of Menjugate® vaccine at 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. Infanrix hexa™ and Menjugate® vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943813|NCT00970307|E1|Reported Event|GSK2202083A + Synflorix Group|Healthy male and female infants between and including 8 to 12 weeks at the time of the first vaccination, who received 3 doses of GSK2202083A vaccine and Synflorix™ vaccine at 2, 3 and 4 months of age and 2 doses of Rotarix™ vaccine at 2 and 3 months of age. GSK2202083A and Synflorix™ vaccines were administered intramuscularly into the right and left thigh, while Rotarix™ vaccine was administered orally.
943814|NCT00970294|B1|Baseline|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
943815|NCT00970294|P1|Participant Flow|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
943816|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
943817|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
943818|NCT00970294|O1|Outcome|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
943819|NCT00970294|E1|Reported Event|Health Promotion Program|Supervised exercise, educational sessions, dietary counseling
943820|NCT00970281|B3|Baseline|Total|Total of all reporting groups
943821|NCT00970281|B2|Baseline|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943822|NCT00970281|B1|Baseline|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943823|NCT00970281|P2|Participant Flow|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943824|NCT00970281|P1|Participant Flow|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943825|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
944903|NCT00966238|B7|Baseline|Total|Total of all reporting groups
943831|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943832|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943833|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943834|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943835|NCT00970281|O2|Outcome|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943836|NCT00970281|O1|Outcome|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943837|NCT00970281|E2|Reported Event|Placebo|Administered by means of IM injection with the possibility of second injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943838|NCT00970281|E1|Reported Event|10 mg Olanzapine|Administered by means of intramuscular injection (IM) with the possibility of second 10 milligram (mg) injection 2 to 4 hours after first injection, for a maximum of 2 injections.
943839|NCT00970268|B3|Baseline|Total|Total of all reporting groups
943840|NCT00970268|B2|Baseline|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
943841|NCT00970268|B1|Baseline|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
943842|NCT00970268|P2|Participant Flow|Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
943843|NCT00970268|P1|Participant Flow|Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment.
943844|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
943845|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
943846|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
943865|NCT00969228|B3|Baseline|Total|Total of all reporting groups
943848|NCT00970268|O4|Outcome|Aclidinium Bromide 400 μg - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 400 microgram of Aclidinium bromide for 12 weeks in the lead-in study.
943849|NCT00970268|O3|Outcome|Placebo - Aclidinium Bromide 400 μg|Aclidinium bromide, 400 microgram dose, oral inhalation, twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
943850|NCT00970268|O2|Outcome|Aclidinium Bromide 200 μg - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment in patients who also received 200 micrograms of Aclidinium bromide for 12 weeks in the lead-in study.
943851|NCT00970268|O1|Outcome|Placebo - Aclidinium Bromide 200 μg|Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment for patients who received 12 weeks of placebo in the lead-in study.
943852|NCT00970268|E4|Reported Event|Aclidinium Bromide 400μg to Aclidinium Bromide 400μg|Patients were given 12 weeks of Aclidinium bromide, 400 microgram dose, then continued with the 400 microgram dose twice per day, oral inhalation, for an additional 52 weeks of treatment.
943853|NCT00970268|E3|Reported Event|Placebo to Aclidinium Bromide 400μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 400 microgram dose, oral inhalation twice per day for 52 weeks of treatment
943854|NCT00970268|E2|Reported Event|Aclidinium Bromide 200 μg to Aclidinium Bromide 200 μg|Patients were given 12 weeks of Aclidinium bromide, 200 microgram dose, then continued with the 200 microgram dose, oral inhalation twice per day for an additional 52 weeks of treatment.
943855|NCT00970268|E1|Reported Event|Placebo to Aclidinium Bromide 200 μg|Patients were given 12 weeks of placebo, then switched to Aclidinium bromide, 200 microgram dose, oral inhalation twice per day for 52 weeks of treatment
943856|NCT00969280|B3|Baseline|Total|Total of all reporting groups
943857|NCT00969280|B2|Baseline|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
943858|NCT00969280|B1|Baseline|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
943917|NCT00969709|E3|Reported Event|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
943918|NCT00969709|E2|Reported Event|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER, low dose, oral administration, once daily for 8 weeks.
943919|NCT00969709|E1|Reported Event|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks.
943859|NCT00969280|P2|Participant Flow|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
943860|NCT00969280|P1|Participant Flow|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
943861|NCT00969280|O2|Outcome|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
943862|NCT00969280|O1|Outcome|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
943863|NCT00969280|E2|Reported Event|Non-acupoint Shallow Penetration Group|17 sham points were selected and acupunctures were also retained for 20 minutes after shallow penetration of the skin without any other manipulation for total 9 sessions. The sham points were as follows: both points 2 cm lateral to ST4, 2 cm below ST7, at the parietal eminence of the head, 2 cm internal to ST9, 10 cm internal to BL57, 1.5 cm internal to ST36, single points at the left middle point of the biceps brachii muscle belly, points at 2 cm, 4 cm and 6 cm from the Lt. wrist fold, and one point located between the Lt. 3rd and 4th metatarsophalangeal joints.
943864|NCT00969280|E1|Reported Event|Standardized Acupuncture Group|Acupuncture treatement was conducted by licensed oriental medicine doctore. total nine acupuncture treatment sessions (three times per week for three weeks)were offered in treatment group. According to Korean traditional theory, 17 acupuncture points were selected for acupuncture (GV23; bilateral BL2, GB14, TE23, Ex1, ST1 and GB20; and unilateral SP3, LU9, LU10 and HT8, on the left for men and right for women), and acupunctures were retained for 20 minutes after “de qi” manipulation for the verum acupuncture group.
943867|NCT00969228|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943868|NCT00969228|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943869|NCT00969228|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943870|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943871|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943872|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943873|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943874|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943875|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943876|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943877|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943878|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943879|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943880|NCT00969228|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943881|NCT00969228|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943882|NCT00969228|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 or 2-month schedule.
943883|NCT00969228|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 or 2-month schedule.
943884|NCT00970216|B1|Baseline|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
943885|NCT00970216|P1|Participant Flow|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
943886|NCT00970216|O1|Outcome|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
943887|NCT00970216|E1|Reported Event|Chronic Hepatitis B|Patients with chronic hepatitis B, who received Telbivudine treatment
943888|NCT00969878|B3|Baseline|Total|Total of all reporting groups
943920|NCT00969618|B1|Baseline|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943921|NCT00969618|P1|Participant Flow|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943922|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943923|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943889|NCT00969878|B2|Baseline|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
943890|NCT00969878|B1|Baseline|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
943891|NCT00969878|P2|Participant Flow|TA-CD Vaccination|"TA-CD 400 μg will be administered intramuscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~TA-CD Vaccination: On Day 1, subjects will be randomized to receive vaccination. Day 1 to Week 16 (3 visits per week) Subsequent vaccinations will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between vaccinations. Three times per week visits will be scheduled during this period through Week 16. The assessments for the active phase will be scheduled. Therapy sessions will be provided by a qualified professional such as a master's level counselor."
943892|NCT00969878|P1|Participant Flow|Placebo Injection|"TA-CD placebo will be administered intra muscular. A total of 5 injections will be given over 12 weeks (i.e., at Day 1 and at the beginning of Weeks 3, 5, 9 and 13).~Placebo Injection: On Day 1, subjects will be randomized to receive placebo injection. Day 1 to Week 16 (3 visits per week) Subsequent placebo injections will be administered at the beginning of Weeks 3, 5, 9 and 13. There should be at least 10 days between injections. Three times per week visits will be scheduled during this period through Week 16. The assessments for the efficacy and safety monitor will be scheduled.Therapy sessions will be provided by a qualified professional such as a master's level counselor."
943893|NCT00969878|O2|Outcome|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
943894|NCT00969878|O1|Outcome|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
943895|NCT00969878|O2|Outcome|TA-CD Vaccination|The group randomized to receive the active medication, received the actual TA-CD vaccination at preset intervals as specified in the approved protocol.
943896|NCT00969878|O1|Outcome|Placebo Injection|A saline injection to mimic the active medication is administered to the Placebo group.
943897|NCT00969878|E2|Reported Event|TA-CD Vaccination|Subjects randomized to the active medication group were injected with the active TA-CD at preset intervals per protocol specifications.
951451|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
943898|NCT00969878|E1|Reported Event|Placebo Injection|Subjects randomized to the placebo group were injected with a saline solution on the same schedule as those in the active medication group.
943899|NCT00969709|B5|Baseline|Total|Total of all reporting groups
943900|NCT00969709|B4|Baseline|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
943901|NCT00969709|B3|Baseline|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
943902|NCT00969709|B2|Baseline|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
943903|NCT00969709|B1|Baseline|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
943904|NCT00969709|P4|Participant Flow|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
943905|NCT00969709|P3|Participant Flow|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
943906|NCT00969709|P2|Participant Flow|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
943907|NCT00969709|P1|Participant Flow|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
943908|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
943909|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|80 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
943910|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|40 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
943911|NCT00969709|O1|Outcome|Placebo|Dose matching placebo capsules, oral administration, once daily dosing for 8 weeks
943912|NCT00969709|O4|Outcome|Levomilnacipran ER 120 mg|"120 mg/day Levomilnacipran ER capsules, high dose, oral administration, once daily dosing~Levomilnacipran ER, high dose, oral administration, in capsule form, once daily for 8 weeks."
943913|NCT00969709|O3|Outcome|Levomilnacipran ER 80 mg|"80 mg/day Levomilnacipran ER capsules, medium dose, oral administration, once daily dosing~Levomilnacipran ER, medium dose, oral administration, in capsule form, once daily for 8 weeks."
943914|NCT00969709|O2|Outcome|Levomilnacipran ER 40 mg|"40 mg/day Levomilnacipran ER capsules, low dose, oral administration, once daily dosing.~Levomilnacipran ER, low dose, oral administration, in capsule form, once daily for 8 weeks."
943915|NCT00969709|O1|Outcome|Placebo|"Dose matching placebo capsules, oral administration, once daily dosing.~Placebo : Matching placebo capsules, oral administration, once daily for 8 weeks."
943916|NCT00969709|E4|Reported Event|Levomilnacipran ER 120 mg|120 mg per day Levomilnacipran ER capsules, oral administration, once daily for 8 weeks.
944904|NCT00966238|B6|Baseline|8.0 µg i.m.|
943925|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943926|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943927|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943928|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943929|NCT00969618|O1|Outcome|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943930|NCT00969618|E1|Reported Event|Atomoxetine|40-120 milligrams/day (mg/day) taken by mouth, once a day for 48 weeks
943931|NCT00969540|B3|Baseline|Total|Total of all reporting groups
943932|NCT00969540|B2|Baseline|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the active mattress cover group for 14 days. After a 7 day washout, they will be entered into the placebo mattress cover group for 14 days.
943933|NCT00969540|B1|Baseline|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects in this crossover double blind designed trial will be randomized into the placebo mattress cover group for 14 days. After a 7 day washout, they will be entered into the active mattress cover group for 14 days.
943934|NCT00969540|P2|Participant Flow|Active Mattress Cover First, Then Placebo Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the active mattress cover or placebo mattress cover for 14 days.
943935|NCT00969540|P1|Participant Flow|Placebo Mattress Cover First, Then Active Mattress Cover|Subjects were randomly assigned in this crossover double blind designed trial to the placebo mattress cover or active mattress cover for 14 days.
943936|NCT00969540|O2|Outcome|Sleep Latency With Active Mattress Cover|Sleep latency with active mattress cover (minutes).
943937|NCT00969540|O1|Outcome|Sleep Latency With Placebo Mattress Cover|Sleep latency with placebo mattress cover (minutes).
943938|NCT00969540|O2|Outcome|Sleep Efficiency With Active Mattress Cover|Sleep efficiency with active mattress cover.
943939|NCT00969540|O1|Outcome|Sleep Efficiency With Placebo Mattress Cover|Sleep efficiency with placebo mattress cover.
943940|NCT00969540|O2|Outcome|Nocturnal Awakenings With Active Mattress Cover|Number of nocturnal awakenings with active mattress cover.
943941|NCT00969540|O1|Outcome|Nocturnal Awakenings With Placebo Mattress Cover|Number of nocturnal awakenings with placebo mattress cover.
943942|NCT00969540|O2|Outcome|Total Sleep With Active Mattress Cover|Total sleep with active mattress cover (minutes).
943943|NCT00969540|O1|Outcome|Total Sleep With Placebo Mattress Cover|Total sleep with placebo mattress cover (minutes).
943944|NCT00969540|O2|Outcome|Nighttime Wake Time With Active Mattress Cover|Nighttime wake time after sleep onset with active mattress cover.
943945|NCT00969540|O1|Outcome|Nighttime Wake Time With Placebo Mattress Cover|Nighttime wake time after sleep onset with placebo mattress cover.
943946|NCT00969540|O4|Outcome|Mean CGI Sleep Scores With Active Mattress Cover.|Mean Clinical Global Impression sleep scores with active mattress cover.
943947|NCT00969540|O3|Outcome|Mean CGI Sleep Scores With Placebo Mattress Cover.|Mean Clinical Global Impression sleep scores with placebo mattress cover.
943948|NCT00969540|O2|Outcome|Mean CGI Pain Scores With Active Mattress Cover.|Mean Clinical Global Impression pain scores with active mattress cover.
943949|NCT00969540|O1|Outcome|Mean CGI Pain Scores With Placebo Mattress Cover.|Mean Clinical Global Impression pain scores with placebo mattress cover.
943950|NCT00969540|E2|Reported Event|Active Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the active mattress cover for 14 days, followed by the placebo mattress cover for 14 days after a 7 day wash out period.
943951|NCT00969540|E1|Reported Event|Placebo Mattress Cover|Subjects will be randomly assigned in this crossover double blind designed trial to the placebo mattress cover for 14 days, followed by the active mattress cover for 14 days after a 7 day wash out period.
943952|NCT00969501|B1|Baseline|EUFLEXXA|ACTIVE CONTROL
943953|NCT00969501|P1|Participant Flow|EUFLEXXA|All subjects received three injections (one each, in weeks 0 [baseline], 1, and 2 of high molecular weight hyaluronate (2.5 mL each) using standard injection techniques in the anterior or posterior approach. Sub- jects were evaluated at screening and baseline, and at weeks 1, 2, 6, 14, 26, and 27 (last evaluation by telephone).
943954|NCT00969501|O1|Outcome|EUFLEXXA|ACTIVE CONTROL
943955|NCT00969501|E1|Reported Event|EUFLEXXA|ACTIVE CONTROL
943956|NCT00969150|B3|Baseline|Total|Total of all reporting groups
943957|NCT00969150|B2|Baseline|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
943958|NCT00969150|B1|Baseline|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
943959|NCT00969150|P2|Participant Flow|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
943960|NCT00969150|P1|Participant Flow|Placebo|Dose Matched placebo capsules, oral administration, once daily dosing for 8 weeks.
943961|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
943962|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
943963|NCT00969150|O2|Outcome|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
943964|NCT00969150|O1|Outcome|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
943965|NCT00969150|E2|Reported Event|Levomilnacipran ER|Levomilnacipran ER capsules, flexible dose, oral administration, once daily dosing for 8 weeks.
943966|NCT00969150|E1|Reported Event|Placebo|Matching placebo capsules, oral administration, once daily dosing for 8 weeks.
943967|NCT00968981|B4|Baseline|Total|Total of all reporting groups
943968|NCT00968981|B3|Baseline|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943969|NCT00968981|B2|Baseline|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943970|NCT00968981|B1|Baseline|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943971|NCT00968981|P3|Participant Flow|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once weekly (QW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943972|NCT00968981|P2|Participant Flow|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule three times weekly (TIW) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943973|NCT00968981|P1|Participant Flow|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule once daily (QD) orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943974|NCT00968981|O1|Outcome|GDC-0449 150 mg: All Participants|All participants received single dose of GDC-0449 150 mg capsule orally on Day 1.
943975|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943976|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943977|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943978|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943979|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943980|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943981|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943982|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943983|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
944101|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
943984|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943985|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943986|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943987|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943988|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943989|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC­0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943990|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943991|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943992|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943993|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943994|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
943995|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943996|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
943997|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
944050|NCT00968812|B2|Baseline|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
943998|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
943999|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
944000|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
944001|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
944002|NCT00968981|O3|Outcome|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
944003|NCT00968981|O2|Outcome|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
944004|NCT00968981|O1|Outcome|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
944005|NCT00968981|E3|Reported Event|GDC-0449 150 mg QW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QW orally from Day 15 to Day 57 (maintenance dose).
944006|NCT00968981|E2|Reported Event|GDC-0449 150 mg TIW|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule TIW orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule TIW orally from Day 15 to Day 57 (maintenance dose).
944007|NCT00968981|E1|Reported Event|GDC-0449 150 mg QD|Single dose of GDC-0449 150 mg capsule orally on Day 1 and then one capsule QD orally from Day 4 to Day 14 (loading dose) followed by 150 mg capsule QD orally from Day 15 to Day 57 (maintenance dose).
944008|NCT00968890|B3|Baseline|Total|Total of all reporting groups
944009|NCT00968890|B2|Baseline|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944010|NCT00968890|B1|Baseline|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944067|NCT00968812|E6|Reported Event|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
944011|NCT00968890|P2|Participant Flow|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944012|NCT00968890|P1|Participant Flow|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944013|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944014|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944015|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944016|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944017|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944018|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944019|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944020|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944021|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944022|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944051|NCT00968812|B1|Baseline|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944905|NCT00966238|B5|Baseline|5.0 µg i.m.|
944023|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944024|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944025|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944026|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944027|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944028|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944029|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944030|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944031|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944032|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944100|NCT00968669|P1|Participant Flow|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944033|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944034|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944035|NCT00968890|O2|Outcome|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944036|NCT00968890|O1|Outcome|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944037|NCT00968890|E2|Reported Event|Pandemrix+Placebo and Pandemrix+Fluarix|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with a placebo on Day 0 and with Fluarix™ on Day 21 intramuscularly in the deltoid region of the dominant arm.
944038|NCT00968890|E1|Reported Event|Pandemrix+Fluarix and Pandemrix+Placebo|Subjects received two doses of Pandemrix (GSK2340272A) intramuscularly in the deltoid region of the non-dominant arm co-administered with Fluarix™ on Day 0 and with a placebo on Day 21 intramuscularly in the deltoid region of the dominant arm.
944039|NCT00968838|B3|Baseline|Total|Total of all reporting groups
944040|NCT00968838|B2|Baseline|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944041|NCT00968838|B1|Baseline|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944042|NCT00968838|P2|Participant Flow|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944043|NCT00968838|P1|Participant Flow|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944044|NCT00968838|O2|Outcome|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944045|NCT00968838|O1|Outcome|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944046|NCT00968838|E2|Reported Event|White Blood Cell Transfusion|Four (4) standard white blood cell transfusions (with radiation). Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944047|NCT00968838|E1|Reported Event|Non-radiated White Blood Cell Transfusion|Four (4) non-radiated white blood cell transfusions. Each transfusion given daily and taking from 1 hour to several hours depending on toleration of the treatment.
944048|NCT00968812|B4|Baseline|Total|Total of all reporting groups
944049|NCT00968812|B3|Baseline|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
944052|NCT00968812|P3|Participant Flow|Glimepiride: Baseline to Week 104|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
944053|NCT00968812|P2|Participant Flow|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944054|NCT00968812|P1|Participant Flow|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944055|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
944056|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944057|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944058|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
944059|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944060|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944061|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
944062|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944063|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944064|NCT00968812|O3|Outcome|Glimepiride|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks.
944065|NCT00968812|O2|Outcome|Canagliflozin 300 mg|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944066|NCT00968812|O1|Outcome|Canagliflozin 100 mg|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks.
944251|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944068|NCT00968812|E5|Reported Event|Canagliflozin 300 mg: Baseline to Week 104|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
944069|NCT00968812|E4|Reported Event|Canagliflozin 100 mg: Baseline to Week 104|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 104.
944070|NCT00968812|E3|Reported Event|Glimepiride: Baseline to Week 52|Each patient received glimepiride, at protocol-specified doses, once daily in combination with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
944071|NCT00968812|E2|Reported Event|Canagliflozin 300 mg: Baseline to Week 52|Each patient received 300 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
944072|NCT00968812|E1|Reported Event|Canagliflozin 100 mg: Baseline to Week 52|Each patient received 100 mg of canagliflozin (JNJ-28431754) once daily with protocol-specified doses of metformin for 104 weeks. Data are presented for Baseline to Week 52.
944073|NCT00968799|B1|Baseline|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
944074|NCT00968799|P1|Participant Flow|HIPEC|"Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)~Tumor nodules are removed surgically. If necessary infested organs like colon are resected (=cytoreduction).~To destroy remaining tumor cells or invisible nodules the peritoneum is prefused with 42°C warm 25 mg/l cisplatin solution. Perfusion volume depends on body size (3 - 6 l).~If cisplatin amount exceeds the equivalent of 62.5 mg/m² body surface, cisplatin is dosed by body surface (62.5 mg/m²)(safety margin).~Perfusion is performed with the open or Coliseum technique for 90 min."
944075|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
944076|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
944077|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
944078|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
944079|NCT00968799|O1|Outcome|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
944080|NCT00968799|E1|Reported Event|HIPEC|Hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC)
944081|NCT00968708|B3|Baseline|Total|Total of all reporting groups
944082|NCT00968708|B2|Baseline|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
944083|NCT00968708|B1|Baseline|Placebo|Alogliptin placebo matching tablets, orally, once daily.
944084|NCT00968708|P2|Participant Flow|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min). Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
944906|NCT00966238|B4|Baseline|3.0 µg i.m.|
944085|NCT00968708|P1|Participant Flow|Placebo|Alogliptin placebo matching tablets, orally, once daily. Participants continued to receive standard of care for cardiovascular disease and diabetes according to regional guidelines.
944086|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
944087|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
944088|NCT00968708|O2|Outcome|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
944089|NCT00968708|O1|Outcome|Placebo|Alogliptin placebo matching tablets, orally, once daily.
944090|NCT00968708|E2|Reported Event|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for participants with normal or mildly impaired renal function as defined by estimated glomerular filtration rate (eGFR) ≥ 60 mL/min). Alogliptin 12.5 mg, tablets, orally, once daily for participants with moderately impaired renal function (eGFR ≥30 and <60 mL/min). Alogliptin 6.25 mg, tablets, orally, once daily for participants with severely impaired renal function or end stage renal disease (eGFR <30 mL/min).
944091|NCT00968708|E1|Reported Event|Placebo|Alogliptin placebo matching tablets, orally, once daily.
944092|NCT00968669|B5|Baseline|Total|Total of all reporting groups
944093|NCT00968669|B4|Baseline|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944094|NCT00968669|B3|Baseline|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944095|NCT00968669|B2|Baseline|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944096|NCT00968669|B1|Baseline|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944097|NCT00968669|P4|Participant Flow|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944098|NCT00968669|P3|Participant Flow|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944099|NCT00968669|P2|Participant Flow|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944102|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944103|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944104|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944105|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944106|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944107|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944108|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944109|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944110|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944111|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944112|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944113|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944114|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944115|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944116|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944117|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944118|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944119|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944120|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944121|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944122|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944123|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944124|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944125|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944126|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944127|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944128|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944129|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944130|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944131|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944132|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944133|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944134|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944135|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944136|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944137|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944138|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944139|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944140|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944141|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944142|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944143|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944144|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944145|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944146|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944147|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944148|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944149|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944150|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
951452|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
944151|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944152|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944153|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944154|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944155|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944156|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944157|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944158|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944159|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944160|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944161|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944162|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944163|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944164|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944165|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944166|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944167|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944168|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944169|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944170|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944171|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944172|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944173|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944174|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944175|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944176|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944907|NCT00966238|B3|Baseline|2.0 µg i.m.|
944908|NCT00966238|B2|Baseline|1.0 µg i.m.|
944177|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944178|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944179|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944180|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944181|NCT00968669|O4|Outcome|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944182|NCT00968669|O3|Outcome|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944183|NCT00968669|O2|Outcome|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944184|NCT00968669|O1|Outcome|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944185|NCT00968669|E4|Reported Event|MEDI528 300 mg|MEDI-528 at a dose of 300 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944186|NCT00968669|E3|Reported Event|MEDI528 100 mg|MEDI-528 at a dose of 100 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944187|NCT00968669|E2|Reported Event|MEDI528 30 mg|MEDI-528 at a dose of 30 mg administered as a subcutaneous injection every 2 weeks for 24 weeks
944188|NCT00968669|E1|Reported Event|Placebo|Placebo administered as a subcutaneous injection every 2 weeks for 24 weeks
944189|NCT00968617|B1|Baseline|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944190|NCT00968617|P1|Participant Flow|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944191|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944192|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944193|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944194|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944195|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944196|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944197|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944198|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944199|NCT00968617|O1|Outcome|MK2578|MK2578 1.0 mcg/kg given subcutaneously (SC) every month.
944200|NCT00968617|E1|Reported Event|MK-2578|
944201|NCT00968227|B1|Baseline|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
944252|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944202|NCT00968227|P1|Participant Flow|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
944203|NCT00968227|O1|Outcome|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
944204|NCT00968227|O1|Outcome|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
944205|NCT00968227|E1|Reported Event|Transfusion|Red blood cell transfusion: Transfusion of 1 unit of packed red blood cells over 1 hour.
944206|NCT00968201|B3|Baseline|Total|Total of all reporting groups
944207|NCT00968201|B2|Baseline|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944208|NCT00968201|B1|Baseline|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944209|NCT00968201|P3|Participant Flow|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
944210|NCT00968201|P2|Participant Flow|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944211|NCT00968201|P1|Participant Flow|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944212|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944213|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944214|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944492|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944215|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944216|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944217|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944218|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944219|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944220|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944253|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
945124|NCT00965497|B1|Baseline|Open-label, Single Arm|All patients will receive the intervention
944221|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944222|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944223|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944224|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944225|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944226|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944227|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944273|NCT00968149|P1|Participant Flow|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944909|NCT00966238|B1|Baseline|0.5 µg i.m.|
944228|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944229|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944230|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944231|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944232|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944254|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944255|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944233|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944234|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944235|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944236|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944237|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944238|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944239|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944240|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944372|NCT00967447|P1|Participant Flow|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
944241|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944242|NCT00968201|O2|Outcome|Montelukast|Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together.
944243|NCT00968201|O1|Outcome|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some patients receiving montelukast in Period II were switched to usual care in the Extension Study. Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944244|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944245|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944246|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944247|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944248|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944249|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944250|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944256|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944257|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944258|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944259|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944260|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944261|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944262|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944263|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944264|NCT00968201|O2|Outcome|Montelukast|Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.
944265|NCT00968201|O1|Outcome|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944266|NCT00968201|E3|Reported Event|Montelukast|"Base Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for 12 weeks.~Extension Study - Montelukast 4 mg chewable tablet orally once daily at bedtime for up to 2.8 years. Some patients receiving placebo in Period II were switched to montelukast in the Extension Study, and some patients receiving montelukast in Period II continued on montelukast in the Extension Study. One hundred sixty-seven patients were switched to the 5 mg chewable tablet at~their first visit after turning 6 years old. The 4 mg and 5 mg chewable tablet data are pooled together."
944267|NCT00968201|E2|Reported Event|Usual Care|"“Usual care,” defined as inhaled/nebulized cromolyn or inhaled/nebulized corticosteroids according to the usual clinical practice of the investigator, for up to 2.8 years. Some patients receiving placebo in Period II were switched to usual care in the Extension Study, and some~patients receiving montelukast in Period II were switched to usual care in the Extension Study.~Patients already using corticosteroids during Period I and II continued on the same medication and dose throughout Period II. Their dose was not increased if they were allocated to the usual care treatment group in Period III."
944268|NCT00968201|E1|Reported Event|Placebo|Montelukast matching-image placebo chewable tablet orally once daily at bedtime for 12 weeks.
944269|NCT00968149|B3|Baseline|Total|Total of all reporting groups
944270|NCT00968149|B2|Baseline|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944271|NCT00968149|B1|Baseline|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944272|NCT00968149|P2|Participant Flow|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944373|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
944274|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944275|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944276|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944277|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944278|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944279|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944280|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944281|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944282|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944283|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944284|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944285|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944345|NCT00967551|B3|Baseline|Total|Total of all reporting groups
944286|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944287|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944288|NCT00968149|O2|Outcome|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944289|NCT00968149|O1|Outcome|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944290|NCT00968149|E2|Reported Event|Placebo|Patients aged 2 to 5 years: montelukast 4 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg matching-image placebo chewable tablet orally once daily at bedtime for 2 weeks.
944291|NCT00968149|E1|Reported Event|Montelukast 4 mg and 5 mg|Patients aged 2 to 5 years: montelukast 4 mg chewable tablet orally once daily at bedtime for 2 weeks. Patients aged 6 to 14 years: montelukast 5 mg chewable tablet orally once daily at bedtime for 2 weeks.
944292|NCT00968071|B1|Baseline|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
944293|NCT00968071|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 intravenously (IV) over an hour and half daily for 5 days plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
944294|NCT00968071|O1|Outcome|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
944295|NCT00968071|E1|Reported Event|Decitabine Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 IV over an hour and half daily for 5 days Plus Gemtuzumab Ozogamicin 3 mg/m^2 IV on day 5.
944296|NCT00968032|B1|Baseline|Nit-Occlud® PFO|
944297|NCT00968032|P1|Participant Flow|Nit-Occlud® PFO Implantation Group|Patients suffering from PFO and suitable for closure of the defect with the Nit-Occlud® PFO Closure Device
944298|NCT00968032|O1|Outcome|Nit-Occlud® PFO|
944299|NCT00968032|E1|Reported Event|Nit-Occlud® PFO|
944300|NCT00968019|B1|Baseline|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944301|NCT00968019|P1|Participant Flow|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944302|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944303|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944304|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944305|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944910|NCT00966238|P6|Participant Flow|8.0 µg i.m.|
944306|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944307|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944308|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944309|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944310|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944311|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944312|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944313|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944314|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944315|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944316|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944317|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944318|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944319|NCT00968019|O1|Outcome|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944320|NCT00968019|E1|Reported Event|Treated With Presillion Stent|Patients treated with the Presillion stent in up to two de novo coronary artery lesions
944321|NCT00967993|B1|Baseline|KRX-0502|All subjects in this group will receive treatment with KRX-0502, 1g ferric citrate containing approximately 210 mg of ferric iron
944322|NCT00967993|P1|Participant Flow|KRX-0502|"All patients initiated on study drug were started on a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients were titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels went below normal, there was a decrease in pills; if serum phosphorus levels went above normal, there was an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day was 12, or 12 g/day of ferric citrate."
944323|NCT00967993|O1|Outcome|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
944324|NCT00967993|E1|Reported Event|KRX-0502 (Ferric Citrate)|Single arm clinical trial of KRX-0502 (ferric citrate)
944325|NCT00967694|B1|Baseline|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
944326|NCT00967694|P1|Participant Flow|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
944327|NCT00967694|O1|Outcome|Nitrous Oxide Administration|All 20 healthy volunteers had their intraocular pressure (IOP) measured at baseline (prior to nitrous oxide administration) and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore one study arm, with each individual serving as their control for baseline (before nitrous oxide administration) and then intervention values of IOP measurement (during nitrous oxide administration), and then washout values of IOP (after breathing room air).
944328|NCT00967694|E1|Reported Event|Nitrous Oxide Administration|20 healthy volunteers had their intraocular pressure (IOP) measured at baseline and then after 3, 6, 9, and 12 minutes of nitrous oxide administration, and then after 5, 10, and 15 minutes of breathing room air. There was therefore only one study arm, with each individual serving as their control for baseline and then intervention values of IOP measurement.
944329|NCT00967668|B4|Baseline|Total|Total of all reporting groups
944330|NCT00967668|B3|Baseline|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
944331|NCT00967668|B2|Baseline|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944374|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
944375|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
944376|NCT00967447|O1|Outcome|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
944377|NCT00967447|E1|Reported Event|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
944378|NCT00967330|B3|Baseline|Total|Total of all reporting groups
944332|NCT00967668|B1|Baseline|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates elements from cognitive behavioral therapy, problem-solving therapy, and behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944333|NCT00967668|P3|Participant Flow|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
944334|NCT00967668|P2|Participant Flow|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944335|NCT00967668|P1|Participant Flow|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944336|NCT00967668|O3|Outcome|Arm 3|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
944337|NCT00967668|O2|Outcome|Arm 2|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944338|NCT00967668|O1|Outcome|Arm 1|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944339|NCT00967668|O3|Outcome|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
944340|NCT00967668|O2|Outcome|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944493|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944341|NCT00967668|O1|Outcome|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944342|NCT00967668|E3|Reported Event|MOVE! Usual Care|"Usual care MOVE!, which consists of weekly on-site group visits that follow MOVE! protocols with unstructured follow-up phone support~MOVE! Usual Care: The MOVE! program offers a stepped-care framework of increasingly intensive treatment. A combination of Level 1 (self-management support) and Level 2 (group sessions and/or individual specialty consultation) will be offered to participants as part of usual care."
944343|NCT00967668|E2|Reported Event|ASPIRE-Group Lifestyle Coaching|"On-site weekly group visits for 3 months, followed by 21 months of follow-up groups. (on-site ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944344|NCT00967668|E1|Reported Event|ASPIRE-Phone Lifestyle Coaching|"Phone-based initial treatment of 3 months, followed by 21 months of follow-up phone support (phone-only ASPIRE-VA)~Small change approach to improving physical activity and diet: The Aspire to Lifelong Health (ASPIRE) program is an innovative approach to weight management drawing on the strengths of both traditional lifestyle change and non-dieting weight loss approaches. ASPIRE incorporates CBT elements, problem-solving therapy, and the small change approach from behavioral choice therapy. For the first week participants use a food diary to track food intake and a pedometer to log their physical activity (step counts). Using this baseline information as a starting point, in each subsequent week participants work with a Lifestyle Coach to set small, but potentially permanent, changes in food choices and physical activity that will promote a caloric deficit. These small changes are cumulative and the participant makes their own goals within the context of their own lifestyle."
944346|NCT00967551|B2|Baseline|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
944347|NCT00967551|B1|Baseline|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
944348|NCT00967551|P2|Participant Flow|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
944349|NCT00967551|P1|Participant Flow|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
944350|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
944351|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
944352|NCT00967551|O2|Outcome|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
944353|NCT00967551|O1|Outcome|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
944354|NCT00967551|E2|Reported Event|Micronutrient Sprinkles With Zinc|"Micronutrient sprinkles with zinc gluconate~Micronutrient Sprinkles with zinc : Daily dose of 1 packet of sprinkles"
944355|NCT00967551|E1|Reported Event|Micronutrient Sprinkles Without Zinc|"Micronutrient sprinkles without zinc~Micronutrient sprinkles without zinc : I packet of micronutrient sprinkles without zinc"
944356|NCT00967486|B3|Baseline|Total|Total of all reporting groups
944357|NCT00967486|B2|Baseline|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
944358|NCT00967486|B1|Baseline|Routine Shunt|routine methods of CEA
944359|NCT00967486|P2|Participant Flow|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
944360|NCT00967486|P1|Participant Flow|Routine Shunt|Routine method of CEA
944361|NCT00967486|O2|Outcome|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
944362|NCT00967486|O1|Outcome|Routine Shunt|routine methods of CEA
944363|NCT00967486|E2|Reported Event|Selective Shunt|Selective method if CEA with based Systolic pressure 40 mmHg
944364|NCT00967486|E1|Reported Event|Routine Shunt|routine methods of CEA
944365|NCT00967473|B1|Baseline|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
944366|NCT00967473|P1|Participant Flow|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
944367|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
944368|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
944369|NCT00967473|O1|Outcome|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
944370|NCT00967473|E1|Reported Event|Toric Intraocular Lens|ACRYSOF® Single-Piece Toric NATURAL IOL Model SN60T9
944371|NCT00967447|B1|Baseline|Dabigatran Exilate 220 Once Daily (OD)|10 days for Knee Replacement or 28-35 Hip Replacement
944911|NCT00966238|P5|Participant Flow|5.0 µg i.m.|
944379|NCT00967330|B2|Baseline|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944380|NCT00967330|B1|Baseline|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944381|NCT00967330|P2|Participant Flow|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944382|NCT00967330|P1|Participant Flow|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944413|NCT00967226|P1|Participant Flow|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.67 mg/kg p.o. TID 4-6 months"
944414|NCT00967226|O2|Outcome|Constitutional AEs Prednisolone|Number of Participants experiencing Constitutional AEs
944383|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944384|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944385|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944386|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944387|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944440|NCT00967226|E2|Reported Event|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 6 months or less"
944441|NCT00967226|E1|Reported Event|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~propranolol: propranolol 0.5 mg/kg p.o. QID 6 months or less"
944388|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944389|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944390|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944391|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944392|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944393|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944394|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944395|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944396|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944442|NCT00967044|B1|Baseline|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by participants), three times per week.~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
944494|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944397|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944398|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944399|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944400|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944401|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944402|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944403|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944404|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944405|NCT00967330|O2|Outcome|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator, if eligible.
944443|NCT00967044|P1|Participant Flow|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
944495|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944406|NCT00967330|O1|Outcome|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944407|NCT00967330|E2|Reported Event|Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gy given 5 fractions per week for 6 to 7 week and temozolomide (TMZ) capsule 75 mg/m^2 BSA daily from the first day to the last day of radiotherapy . There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of TMZ 150 to 200 mg/m^2 BSA daily in the first 5 days of each cycle until PD or for a maximum treatment period of 2 years after inclusion of the last participant. Only participants with progressive disease during or after TMZ therapy could receive bevacizumab (BEV)/irinotecan (IRI) or BEV monotherapy as optional second-line study therapy at the discretion of the investigator or and, if eligible.
944408|NCT00967330|E1|Reported Event|Bevacizumab + Irinotecan|In the Concurrent Phase participants received radiotherapy in daily fractions of 1.8 to 2 Gray (Gy) given 5 fractions per week for 6 to 7 weeks and intravenous infusion (IV) of bevacizumab (BEV) 10 milligrams per kilogram (mg/kg) body weight every 14 ± 2 days starting during the first week to the last week of radiotherapy. Participants then entered the Maintenance Phase where they received BEV 10 mg/kg body weight and IV irinotecan (IRI) 125 milligrams per square meter (mg/m^2) body surface area (BSA) or 340 mg/m^2 BSA in participants not receiving enzyme-inducing antiepileptic drugs (EIAEDs) or receiving EIAEDs, respectively for every 14± 2 days until progressive disease (PD) or for a maximum treatment period of 2 years after inclusion of the last participant.
944409|NCT00967226|B3|Baseline|Total|Total of all reporting groups
944410|NCT00967226|B2|Baseline|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
944411|NCT00967226|B1|Baseline|Propranolol|"Assessing efficacy and tolerability of propranolol in management of symptomatic hemangiomas~Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)"
944412|NCT00967226|P2|Participant Flow|Prednisolone|"Assessing efficacy and tolerability of prednisolone in management of symptomatic hemangiomas and comparing to propranolol.~Prednisolone: 1.0 mg/kg p.o. BID 4-6 months"
944415|NCT00967226|O1|Outcome|Constitutional AEs Propranolol|Number of Participants experiencing Constitutional AEs
944416|NCT00967226|O2|Outcome|Vascular AEs Prednisolone|Number of participants experiencing Vascular AEs
944417|NCT00967226|O1|Outcome|Vascular AEs Propranolol|Number of participants experiencing Vascular AEs
944418|NCT00967226|O2|Outcome|Metabolic/Laboratory AEs Prednisolone|Number of participants experiencing Metabolic or Laboratory AEs in each study arm.
944419|NCT00967226|O1|Outcome|Metabolic/Laboratory AEs Propranolol|Number of participants experiencing Metabolic or Laboratory AEs.
944420|NCT00967226|O2|Outcome|Infectious AEs Prednisolone|Number of participants experiencing Infectious AEs
944421|NCT00967226|O1|Outcome|Infectious AEs Propranolol|Number of participants experiencing Infectious AEs
944422|NCT00967226|O2|Outcome|Gastrointestinal AEs Prednisolone|Number of Participants experiencing Gastrointestinal AEs
944423|NCT00967226|O1|Outcome|Gastrointestinal AEs Propranolol|Number of Participants experiencing Gastrointestinal AEs
944424|NCT00967226|O2|Outcome|Endocrinologic AEs Prednisolone|Number of participants experiencing Endocrinologic AEs.
944425|NCT00967226|O1|Outcome|Endocrine AEs Propranolol|Number of participants experiencing Endocrinologic AEs.
944426|NCT00967226|O2|Outcome|Dermatologic AEs Prednisolone|Number of participants experiencing Dermatologic AEs
944427|NCT00967226|O1|Outcome|Dermatologic AEs Propranolol|Number of participants experiencing Dermatologic AEs
944428|NCT00967226|O2|Outcome|Allergy/Immunology Events Prednisolone|Adverse events in allergy/immunology in prednisolone treated participants
944429|NCT00967226|O1|Outcome|Allergy/Immunology Events Propranolol|Adverse events in allergy/immunology in propranolol treated participants
944430|NCT00967226|O2|Outcome|Pulmonary/Respiratory AEs Prednisolone|Number of participants experiencing pulmonary/respiratory AEs
944431|NCT00967226|O1|Outcome|Pulmonary/Respiratory AEs Propranolol|Number of participants experiencing pulmonary/respiratory AEs
944432|NCT00967226|O2|Outcome|Growth/Development AEs Prednisolone|Number of participants experiencing Growth/Development AEs
944433|NCT00967226|O1|Outcome|Growth/Developoment AEs Propranolol|Number of participants experiencing Growth/Development AEs
944434|NCT00967226|O2|Outcome|Number of Serious Adverse Events in Prednisolone|Serious adverse events in prednisolone treated participants
944435|NCT00967226|O1|Outcome|Number of Serious Adverse Events in Propranolol|Serious adverse events in propranolol treated participants.
944436|NCT00967226|O2|Outcome|Overall Number of Adverse Events in Prednisolone|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
944437|NCT00967226|O1|Outcome|Overall Number of Adverse Events in Propranolol|"All (total) study adverse events displayed as Adverse events including mild, moderate, and severe; as well as Serious Adverse Events"
944438|NCT00967226|O2|Outcome|Prednisolone|"A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months~Prednisolone: 1.0 mg/kg p.o. BID x 4-6 months (2.0 mg/kg/day)"
944439|NCT00967226|O1|Outcome|Propranolol|A priori analysis, TSA (length x width) at baseline versus at 4 months with surrogate data at 5 months Propranolol 0.67 mg/kg p.o. TID x 4 - 6 months (2.0 mg/kg/day)
944491|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944444|NCT00967044|O1|Outcome|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
944445|NCT00967044|E1|Reported Event|Panobinostat + Everolimus|"Panobinostat (LBH589) Plus Everolimus (RAD001)~Panobinostat: Starting dose of 10 mg by mouth per day, self-administered (by patients), three times per week~Everolimus: Starting dose of 5 mg every day by mouth with 1 cup (8 ounces) of water, in morning after eating a low-fat meal."
944446|NCT00967018|B1|Baseline|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
944447|NCT00967018|P1|Participant Flow|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
944448|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
944449|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
945125|NCT00965497|P1|Participant Flow|Open-label, Single Arm|All patients will receive the intervention
944450|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
944451|NCT00967018|O1|Outcome|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
944452|NCT00967018|E1|Reported Event|Degarelix|The degarelix doses were administered into the abdominal wall every 28 days. For patients treated with goserelin in the previous trials (CS28, CS30 and CS31),a starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to the end of the trial. For patients treated with degarelix in the previous trials, maintenance doses of 80 mg (20 mg/mL) degarelix were continued and were administered as single 4 mL s.c. injections at 28 day intervals to the end of the trial.
944453|NCT00966992|B3|Baseline|Total|Total of all reporting groups
944454|NCT00966992|B2|Baseline|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
944455|NCT00966992|B1|Baseline|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944456|NCT00966992|P2|Participant Flow|Arm 2 (Zometa)|"Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.~Zoledronic acid"
944457|NCT00966992|P1|Participant Flow|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944458|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
944459|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944460|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
944461|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944462|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
944463|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944464|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
944465|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944466|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
944467|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944512|NCT00966875|B4|Baseline|30 mg LY2439821 [bDMARD-naive Population|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944468|NCT00966992|O2|Outcome|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
944469|NCT00966992|O1|Outcome|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944470|NCT00966992|E2|Reported Event|Arm 2 (Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. Women randomized to zoledronic acid will receive 4 mg intravenously (IV) with their first dose chemotherapy and 3, 6 and 9 months after completion of radiation (total of 4 doses) along with scheduled follow-up dual-energy X-ray absorptiometry (DEXA) and biomarker studies.
944471|NCT00966992|E1|Reported Event|Arm 1 (No Zometa)|Women will complete their standard chemoradiation treatment protocol and end of treatment PET scan at about 3 months from completion of radiation. All interventions on this arm are standard of care.
944472|NCT00966953|B5|Baseline|Total|Total of all reporting groups
944473|NCT00966953|B4|Baseline|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
944474|NCT00966953|B3|Baseline|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
944475|NCT00966953|B2|Baseline|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
944476|NCT00966953|B1|Baseline|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
944477|NCT00966953|P4|Participant Flow|Magnolol, Total/Whitening, Honokiol, Fluoride Control|1st-fluoride/Magnolol, 2nd-Fluoride/triclosan control, 3rd-fluoride/Honokiol,4th-fluoride only control
944478|NCT00966953|P3|Participant Flow|Honokiol, Fluoride Control, Magnolol, Total/Whitening|1st-fluoride/honokiol, 2nd-fluoride only control, 3rd-fluoride/magnolol,4th-triclosan/fluoride control
944479|NCT00966953|P2|Participant Flow|Total/Whitening, Honokiol, Fluoride Control, Magnolol|1st-triclosan/fluoride control, 2nd-fluoride/honokiol, 3rd-fluoride only control,4th-fluoride/magnolol
944480|NCT00966953|P1|Participant Flow|Fluoride Control, Magnolol,Total/Whitening,Honokiol|1st-fluoride only control,2nd-fluoride/magnolol,3rd-triclosan/fluoride control, 4th-fluoride/honokiol
944481|NCT00966953|O4|Outcome|Herbal Extract Toothpaste|Fluoride/Magnolol extract toothpaste
944482|NCT00966953|O3|Outcome|Herbal Extract Toothpaste|Fluoride/Honokiol extract toothpaste
944483|NCT00966953|O2|Outcome|Total/Whitening|Control toothpaste
944484|NCT00966953|O1|Outcome|Fluoride Only|Control toothopaste
944485|NCT00966940|B3|Baseline|Total|Total of all reporting groups
944486|NCT00966940|B2|Baseline|Tafluprost-to-travoprost|Tafluprost, then travoprost
944487|NCT00966940|B1|Baseline|Travoprost-to-tafluprost|Travoprost, then tafluprost
944488|NCT00966940|P2|Participant Flow|Tafluprost-to-travoprost|Tafluprost, then travoprost
944489|NCT00966940|P1|Participant Flow|Travoprost-to-tafluprost|Travoprost, then tafluprost
944490|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944912|NCT00966238|P4|Participant Flow|3.0 µg i.m.|
944496|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944497|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944498|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944499|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944500|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944501|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944502|NCT00966940|O2|Outcome|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944503|NCT00966940|O1|Outcome|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944504|NCT00966940|E2|Reported Event|Tafluprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944505|NCT00966940|E1|Reported Event|Travoprost|One drop in the qualifying eye(s) each evening at 6:00 PM for six weeks, administered topically
944506|NCT00966875|B10|Baseline|Total|Total of all reporting groups
944507|NCT00966875|B9|Baseline|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944508|NCT00966875|B8|Baseline|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944509|NCT00966875|B7|Baseline|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944510|NCT00966875|B6|Baseline|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944511|NCT00966875|B5|Baseline|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
945126|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
944513|NCT00966875|B3|Baseline|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944514|NCT00966875|B2|Baseline|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944515|NCT00966875|B1|Baseline|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944516|NCT00966875|P9|Participant Flow|180 mg LY2439821 [TNFα-IR Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944517|NCT00966875|P8|Participant Flow|80 mg LY2439821 [TNFα-IR Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944518|NCT00966875|P7|Participant Flow|Placebo [TNFα-IR Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Tumor Necrosis Factor Alpha-Inadequate Responder (TNFα-IR)]
944519|NCT00966875|P6|Participant Flow|180 mg LY2439821[bDMARD-naive Population]|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944520|NCT00966875|P5|Participant Flow|80 mg LY2439821 [bDMARD-naive Population]|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944521|NCT00966875|P4|Participant Flow|30 mg LY2439821 [bDMARD-naive Population]|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944522|NCT00966875|P3|Participant Flow|10 mg LY2439821 [bDMARD-naive Population]|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944523|NCT00966875|P2|Participant Flow|3 mg LY2439821 [bDMARD-naive Population]|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944524|NCT00966875|P1|Participant Flow|Placebo [bDMARD-naive Population]|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 milligrams (mg) LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60. [Biologic Disease Modifying Anti-Rheumatic Drug (bDMARD)]
944525|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944526|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944913|NCT00966238|P3|Participant Flow|2.0 µg i.m.|
944527|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944528|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944529|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944530|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944531|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944532|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944533|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944534|NCT00966875|O8|Outcome|Part B: 160 mg LY2439821 (bDMARD-naive and TNFα-IR Population)|160 mg LY2439821 administered subcutaneously at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60, in Part B.
944535|NCT00966875|O7|Outcome|Part A: 180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944536|NCT00966875|O6|Outcome|Part A: 80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944537|NCT00966875|O5|Outcome|Part A: 180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944538|NCT00966875|O4|Outcome|Part A: 80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944539|NCT00966875|O3|Outcome|Part A: 30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944540|NCT00966875|O2|Outcome|Part A: 10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944541|NCT00966875|O1|Outcome|Part A: 3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944542|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944543|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944544|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944545|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944546|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944547|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944548|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944549|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944550|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944551|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944552|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944553|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944554|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944555|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944914|NCT00966238|P2|Participant Flow|1.0 µg i.m.|
944556|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944557|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944558|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944559|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944560|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944561|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944562|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944563|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944564|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944565|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944566|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944627|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944567|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944568|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944569|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944570|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944571|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944572|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944573|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944574|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944575|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944576|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944577|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944578|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944579|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944580|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944581|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944678|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944582|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944583|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944584|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944585|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944586|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944587|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944588|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944589|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944590|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944591|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944592|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944593|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944594|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944595|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
945127|NCT00965497|O1|Outcome|Escitalopram|One-arm study of escitalopram 20 mg daily
944596|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944597|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944598|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944599|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944600|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944601|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944602|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944603|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944604|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944605|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944606|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944607|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944608|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944609|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944610|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944611|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944612|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944613|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944614|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944915|NCT00966238|P1|Participant Flow|0.5 µg i.m.|
944615|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944616|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944617|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944618|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944619|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944620|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944621|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944622|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944623|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944624|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944625|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944626|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944628|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944629|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944630|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944631|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944632|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944633|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944634|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944635|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944636|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944637|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944638|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944639|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944640|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944641|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944642|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944643|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944644|NCT00966875|O6|Outcome|180 mg LY2439821(bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944645|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944646|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944916|NCT00966238|O6|Outcome|8.0 µg i.m.|
944647|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944648|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944649|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944650|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944651|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944652|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944653|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944654|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944655|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944656|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944657|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944756|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944658|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944659|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944660|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944661|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944662|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population])|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944663|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944664|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944665|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944666|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944667|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944668|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944669|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944670|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944671|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944672|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944673|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944674|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944675|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944676|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944677|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944679|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944680|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944681|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944682|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944683|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944684|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944685|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944686|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944687|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944688|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944689|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944690|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944691|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944692|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944693|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944694|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944695|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944696|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944697|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944698|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944699|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944700|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944701|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944702|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944703|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944704|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944705|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944706|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944707|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944708|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944709|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944710|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944809|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944711|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944712|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944713|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944714|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944715|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944716|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944717|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944718|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944719|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944720|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944721|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944722|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944723|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944757|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
951453|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
944724|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821 (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944725|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944726|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944727|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944728|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944729|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944730|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944731|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944732|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944733|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944734|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944735|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944736|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944737|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944738|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944739|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944740|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944741|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944742|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944743|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944896|NCT00966264|B1|Baseline|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
944744|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944745|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944746|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944747|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944748|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944749|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944750|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944751|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944752|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944753|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944754|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944755|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944758|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944759|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944760|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944761|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944762|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944763|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944764|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944765|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944766|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944767|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944768|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944769|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944770|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944771|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944772|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944773|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944774|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 milligram (mg) LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944775|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944776|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944897|NCT00966264|P2|Participant Flow|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
944777|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944778|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944779|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944780|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944781|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944782|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944783|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944784|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821(bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944785|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944786|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944787|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
945128|NCT00965497|E1|Reported Event|Open-label, Single Arm|All patients will receive the intervention
944788|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944789|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944790|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944791|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944792|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944793|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944794|NCT00966875|O9|Outcome|180 mg/160 mg LY2439821(TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944795|NCT00966875|O8|Outcome|80 mg/160 mg LY2439821(TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944796|NCT00966875|O7|Outcome|Placebo/160 mg LY2439821(TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944797|NCT00966875|O6|Outcome|180 mg/160 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944798|NCT00966875|O5|Outcome|80 mg/160 mg LY2439821(bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944799|NCT00966875|O4|Outcome|30 mg/160 mg LY2439821(bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944800|NCT00966875|O3|Outcome|10 mg/160 mg LY2439821(bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944801|NCT00966875|O2|Outcome|3 mg/160 mg LY2439821(bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944802|NCT00966875|O1|Outcome|Placebo/160 mg LY2439821 (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944803|NCT00966875|O9|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944804|NCT00966875|O8|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944805|NCT00966875|O7|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944806|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944807|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944808|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944810|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944811|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944812|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944813|NCT00966875|O1|Outcome|3 mg to 180 mg (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944814|NCT00966875|O1|Outcome|3 mg to 180 mg LY2439821 (bDMARD-naive Population)|3 mg to 180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944815|NCT00966875|O3|Outcome|180 mg LY2439821 (TNFα-IR Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944816|NCT00966875|O2|Outcome|80 mg LY2439821 (TNFα-IR Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944817|NCT00966875|O1|Outcome|Placebo (TNFα-IR Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944818|NCT00966875|O6|Outcome|180 mg LY2439821 (bDMARD-naive Population)|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944819|NCT00966875|O5|Outcome|80 mg LY2439821 (bDMARD-naive Population)|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944820|NCT00966875|O4|Outcome|30 mg LY2439821 (bDMARD-naive Population)|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944821|NCT00966875|O3|Outcome|10 mg LY2439821 (bDMARD-naive Population)|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944822|NCT00966875|O2|Outcome|3 mg LY2439821 (bDMARD-naive Population)|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944823|NCT00966875|O1|Outcome|Placebo (bDMARD-naive Population)|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A.
944824|NCT00966875|E18|Reported Event|Placebo/160 mg LY2439821 (TNFa-IR Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
945768|NCT00963638|E1|Reported Event|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
944825|NCT00966875|E17|Reported Event|180 mg/160 mg LY2439821 (TNFa-IR Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944826|NCT00966875|E16|Reported Event|80 mg/160 mg LY2439821 (TNFa-IR Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944827|NCT00966875|E15|Reported Event|Placebo/160 mg LY2439821 (bDMARD-naive Population) Part B|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944828|NCT00966875|E14|Reported Event|180 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944829|NCT00966875|E13|Reported Event|80 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944830|NCT00966875|E12|Reported Event|30 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944831|NCT00966875|E11|Reported Event|10 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944832|NCT00966875|E10|Reported Event|3 mg/160 mg LY2439821 (bDMARD-naive Population) Part B|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944833|NCT00966875|E9|Reported Event|Placebo (TNFa-IR Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944834|NCT00966875|E8|Reported Event|180 mg LY2439821 (TNFa-IR Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944835|NCT00966875|E7|Reported Event|80 mg LY2439821 (TNFa-IR Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944836|NCT00966875|E6|Reported Event|Placebo (bDMARD-naive Population) Part A|Placebo administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944837|NCT00966875|E5|Reported Event|180 mg LY2439821(bDMARD-naive Population) Part A|180 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944838|NCT00966875|E4|Reported Event|80 mg LY2439821 (bDMARD-naive Population) Part A|80 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944839|NCT00966875|E3|Reported Event|30 mg LY2439821 (bDMARD-naive Population) Part A|30 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944840|NCT00966875|E2|Reported Event|10 mg LY2439821 (bDMARD-naive Population) Part A|10 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944841|NCT00966875|E1|Reported Event|3 mg LY2439821 (bDMARD-naive Population) Part A|3 mg LY2439821 administered subcutaneously at Weeks 0, 1, 2, 4, 6, 8 and 10 in Part A, followed by 160 mg LY2439821 in Part B (optional) at Weeks 16, 18, 20 and every 4 weeks thereafter through Week 60.
944842|NCT00966823|B1|Baseline|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944843|NCT00966823|P1|Participant Flow|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944844|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944845|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944846|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944847|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944848|NCT00966823|O1|Outcome|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944849|NCT00966823|E1|Reported Event|Detachable Balloon|"Fetuses treated with endoscopic tracheal occlusion~Fetal tracheal obstruction with detachable balloon (device): - Endoscopic placement of a detachable balloon in the fetal trachea at 28-30 weeks gestation.~- Ultrasound-guided puncture of balloon or, if not feasible, repeat endoscopic tracheoscopy with puncture and retrieval of the balloon at 34 weeks gestation."
944850|NCT00966641|B1|Baseline|All Study Participants|All study participants who were enrolled in the study.
944851|NCT00966641|P2|Participant Flow|Naproxen First, Then PL3100|"First Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen~(after 7-14 day washout period)~Second Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)"
944852|NCT00966641|P1|Participant Flow|PL3100 First, Then Naproxen|"First Intervention Period:~PL3100 Capsules: Single orally administered dose of PL 3100 (500 mg naproxen)~(after 7-14 day washout period)~Second Intervention Period:~Naproxen: Single orally administered dose of 500 mg naproxen"
944853|NCT00966641|O2|Outcome|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
944854|NCT00966641|O1|Outcome|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
944855|NCT00966641|E2|Reported Event|Naproxen|"Active comparator~Naproxen: Single orally administered dose of 500 mg naproxen"
944856|NCT00966641|E1|Reported Event|PL 3100|"Active experimental drug~PL 3100: Single orally administered dose of PL 3100 (500 mg naproxen)"
944857|NCT00966550|B3|Baseline|Total|Total of all reporting groups
944858|NCT00966550|B2|Baseline|Non-tomato First Then Tomato|"Non-tomato high fat test meal~Non-tomato test meal: non-tomato with High fat test meal"
944859|NCT00966550|B1|Baseline|Tomato First Then Non-tomato|"tomato High fat test meal~Tomato products: tomato with High fat test meal"
944860|NCT00966550|P2|Participant Flow|Non-tomato First Then Tomato|Non-tomato :High fat meal with non-tomato
944861|NCT00966550|P1|Participant Flow|Tomato First Then Non-tomato|Tomato :High fat meal with tomato
944862|NCT00966550|O2|Outcome|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
944863|NCT00966550|O1|Outcome|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
944864|NCT00966550|E2|Reported Event|Non-tomato|"Non-tomato high fat test meal~Non-tomato test meal: High fat non-tomato test meal"
944865|NCT00966550|E1|Reported Event|Tomato|"High fat tomato test meal~Tomato products: High fat tomato test meal"
944866|NCT00966446|B4|Baseline|Total|Total of all reporting groups
944867|NCT00966446|B3|Baseline|No Intervention|Households do not undergo active MRSA decolonization protocol. The received education only. The content of the education focused on personal hygiene (hand hygiene and bathing), interrupting transmission (avoidance of shared towels, razors, etc.), and household hygiene (regular washing of linens and towels, disposal of potentially infective materials such as bandages).
944868|NCT00966446|B2|Baseline|Supervised Decolonization|This group was also randomized to the decolonization protocol. In addition those randomized to supervised decolonization received daily phone calls or text messages during the decolonization protocol period in order to remind enrolled subjects to perform the indicated procedure in addition to the instruction and education received during the initial interview.
944898|NCT00966264|P1|Participant Flow|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
944899|NCT00966264|O2|Outcome|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
944900|NCT00966264|O1|Outcome|LNG-IUS|Levonorgestrel releasing intrauterine system (LNG-IUS)
944901|NCT00966264|E2|Reported Event|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
944869|NCT00966446|B1|Baseline|Unsupervised Decolonization|"This group was randomized to the following decolonization protocol: 1) 2% mupirocin ointment applied inside both nares twice daily for seven days 2) a 4% chlorhexidine gluconate (Hibiclens, Mo¨lnlycke Health Care, Norcross, Georgia) body wash, including entire skin surface, excluding face and hair, with particular attention to axillae, inguinal region, and perirectal areas, performed on both the first and the last day of mupirocin use. Subjects were asked to record performance of each step of the decolonization protocol in a journal, which was returned at the end of the period of medication use, along with any unused portion of the mupirocin and chlorhexidine gluconate body wash containers. The subjects randomized to unsupervised decolonization were instructed on the decolonization protocol during the initial interview, along with the educational instruction as described in the no intervention group."
944870|NCT00966446|P3|Participant Flow|No Intervention|Households do not undergo active MRSA decolonization protocol
944871|NCT00966446|P2|Participant Flow|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
944948|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
944949|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
945160|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
944872|NCT00966446|P1|Participant Flow|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
944873|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
944874|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
944875|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
944876|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
944877|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
944878|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
944879|NCT00966446|O3|Outcome|No Intervention|No decolonization agents
944880|NCT00966446|O2|Outcome|Supervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7 with daily call/text message reminders
944881|NCT00966446|O1|Outcome|Unsupervised Decolonization|Mupirocin topical to nares twice daily x7 days; Chlorhexidine bath on Days 1 and 7
944882|NCT00966446|E3|Reported Event|No Intervention|Households do not undergo active MRSA decolonization protocol
944883|NCT00966446|E2|Reported Event|Supervised Decolonization|"Households undergo decolonization for MRSA. Intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. To ensure compliance, study staff is in contact with household members.~Supervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. Intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment AND using Hibliclens body wash twice total (day 1 and day 7 of study enrollment) according to the instructions provided. Households are asked to fill out logs tracking compliance for each household member. Study staff contacts households daily (phone/text) to ensure complicane, to provide reminders to household members to perform the decolonization protocol, and to answer study question/concerns."
944884|NCT00966446|E1|Reported Event|Unsupervised Decolonization|"Households undergo decolonization for MRSA. The intervention includes applying Mupirocin ointment twice daily for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided.~Unsupervised Decolonization: Households will undergo decolonization for MRSA with Mupirocin nasal ointment and Hibiclens body wash. This means that the intervention includes applying Mupirocin ointment twice daily in each nostril for the first 7 days of study enrollment as well as using Hibliclens body wash twice total (on day 1 and day 7 of study enrollment) according to the instructions provided. Households are given detailed, written instructions and are asked to fill out logs tracking compliance for each household member."
944885|NCT00966277|B3|Baseline|Total|Total of all reporting groups
944886|NCT00966277|B2|Baseline|Group 2: Control|No Dalteparin study drug.
944887|NCT00966277|B1|Baseline|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
944888|NCT00966277|P2|Participant Flow|Group 2: Control|No Dalteparin study drug (primary prophylaxis).
944889|NCT00966277|P1|Participant Flow|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
944890|NCT00966277|O2|Outcome|Group 2: Control|No Dalteparin study drug.
944891|NCT00966277|O1|Outcome|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
944892|NCT00966277|E2|Reported Event|Group 2: Control|No Dalteparin study drug.
944893|NCT00966277|E1|Reported Event|Group 1: Dalteparin|Dalteparin 5000 units subcutaneous, by injection under the skin, daily for 16 weeks.
944894|NCT00966264|B3|Baseline|Total|Total of all reporting groups
944895|NCT00966264|B2|Baseline|Hysterectomy|Hysterectomy (abdominal,laparoscopical or vaginal)
944936|NCT00966186|B1|Baseline|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
944937|NCT00966186|P2|Participant Flow|Rotational Technique|
944938|NCT00966186|P1|Participant Flow|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
944939|NCT00966186|O2|Outcome|Rotational Technique|
944940|NCT00966186|O1|Outcome|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
944941|NCT00966186|E2|Reported Event|Rotational Technique|
944942|NCT00966186|E1|Reported Event|Standard Technique|Proseal laryngeal mask airway was inserted according to the manufacture's instruction manual
944943|NCT00965848|B1|Baseline|Entire Study Population|
944944|NCT00965848|P3|Participant Flow|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
944945|NCT00965848|P2|Participant Flow|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
944946|NCT00965848|P1|Participant Flow|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
944947|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
944950|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
944951|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
944952|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
944953|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
944954|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
944955|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
944956|NCT00965848|O3|Outcome|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
944957|NCT00965848|O2|Outcome|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
944958|NCT00965848|O1|Outcome|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
944959|NCT00965848|E3|Reported Event|Complicated Urinary Tract Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated urinary tract infections up to maximum of 10 days.
944960|NCT00965848|E2|Reported Event|Complicated Intra-Abdominal Infections|Doripenem was administered as 1 or 4 hours intravenous infusion at a dose of 500 mg every 8 hours in participants with complicated intra-abdominal infections up to maximum of 14 days.
944961|NCT00965848|E1|Reported Event|Nosocomial Pneumonia|Doripenem was administered as 1 or 4 hours intravenous infusion (directly into the vein) at a dose of 500 milligram (mg) every 8 hours in participants with nosocomial pneumonia up to maximum of 14 days.
944962|NCT00965757|B3|Baseline|Total|Total of all reporting groups
944963|NCT00965757|B2|Baseline|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944964|NCT00965757|B1|Baseline|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
944965|NCT00965757|P4|Participant Flow|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944966|NCT00965757|P3|Participant Flow|T-614 (Extension, 29-52 Weeks)|T-614 was administered in combination with methotrexate. Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
944967|NCT00965757|P2|Participant Flow|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
945013|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
944968|NCT00965757|P1|Participant Flow|T-614 (Double-blind, 1-28 Weeks)|T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.
944969|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944970|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944971|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944972|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944973|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944974|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
945769|NCT00963599|B5|Baseline|Total|Total of all reporting groups
944975|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944976|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944977|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944978|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944979|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944980|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944981|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944982|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944983|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944984|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944985|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944986|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944987|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944988|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
945014|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
944989|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944990|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944991|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944992|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944993|NCT00965757|O3|Outcome|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944994|NCT00965757|O2|Outcome|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
945122|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
945123|NCT00965523|E1|Reported Event|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
944995|NCT00965757|O1|Outcome|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944996|NCT00965757|E3|Reported Event|Placebo/T-614 (Extension, 29-52 Weeks)|Participants entered from double-blind placebo phase to 24-week open-label extension phase to receive T-614. T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day for subsequent 20 weeks (25 mg twice daily).
944997|NCT00965757|E2|Reported Event|Placebo (Double-blind, 1-28 Weeks)|Placebo was administered in combination with methotrexate. Placebo was administered orally at dosages of a tablet once daily for first 4 weeks and a tablet twice daily for subsequent 24 weeks in double-blind period.
944998|NCT00965757|E1|Reported Event|T-614 (Double-blind, 1-28 Weeks) and (Extension, 29-52 Weeks)|"T-614 was administered in combination with methotrexate. Double blind phase-T-614 was orally administered at dosages of 25 mg/day for the first 4 weeks (25 mg once daily) and 50 mg/day (25 mg twice daily) for subsequent 24 weeks.~Extension phase- T-614 was orally administered at a dosage of 50 mg/day (25 mg twice daily) for subsequent 24 weeks."
944999|NCT00965731|B3|Baseline|Total|Total of all reporting groups
945000|NCT00965731|B2|Baseline|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945001|NCT00965731|B1|Baseline|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945002|NCT00965731|P2|Participant Flow|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945003|NCT00965731|P1|Participant Flow|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945004|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945005|NCT00965731|O1|Outcome|All Treated Participants (Phase 1)|All participants who received PF-02341066 (200 mg or 150 mg) administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945006|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945007|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341033 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles
945008|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945009|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945010|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945011|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945012|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945104|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
945015|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945016|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945017|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945018|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945019|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945020|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945021|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945022|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945023|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945024|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945025|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945026|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles.
945027|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945028|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945029|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945030|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945031|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945032|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945033|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945034|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945035|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945036|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945037|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945038|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945039|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945040|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945105|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945041|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945042|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945043|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945044|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945045|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
951454|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
945046|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945047|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945048|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945049|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945050|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945051|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945052|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945053|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945054|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945055|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945056|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945057|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945058|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945106|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
951320|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
945059|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945060|NCT00965731|O2|Outcome|Erlotinib|Erlotinib 150 mg was to be administered orally QD in continuous 21-day cycles
945061|NCT00965731|O1|Outcome|PF-02341066 and Erlotinib|PF-02341066 (BID) and erlotinib (QD) administered at the recommended Phase 2 dose (RP2D) in continuous 21-day cycles.
945062|NCT00965731|O2|Outcome|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID and erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945063|NCT00965731|O1|Outcome|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) and erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945064|NCT00965731|E2|Reported Event|PF-02341066 (150 mg) and Erlotinib (100 mg)|PF-02341066 150 mg administered orally BID in combination with erlotinib 100 mg administered orally QD in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
951455|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
945065|NCT00965731|E1|Reported Event|PF-02341066 (200 mg) and Erlotinib (100 mg)|PF-02341066 200 milligrams (mg) administered orally twice daily (BID) in combination with erlotinib 100 mg administered orally once daily (QD) in a continuous schedule for 28 days (Cycle 1) and then in continuous 21-day cycles. Prior to combination treatment, participants completed a 7 to 14 day lead-in period where they received erlotinib 100 mg administered orally QD.
945066|NCT00965718|B1|Baseline|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945067|NCT00965718|P1|Participant Flow|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945068|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945069|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945070|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945071|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945072|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945073|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945074|NCT00965718|O1|Outcome|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945075|NCT00965718|E1|Reported Event|Immuncell-LC Group|Activated T lymphocyte, intravenous dripping of 200ml (10^9~2*10^10 lymphocytes / 60kg adult) for 1 hour.
945076|NCT00965562|B4|Baseline|Total|Total of all reporting groups
945077|NCT00965562|B3|Baseline|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945078|NCT00965562|B2|Baseline|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945079|NCT00965562|B1|Baseline|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945080|NCT00965562|P3|Participant Flow|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945081|NCT00965562|P2|Participant Flow|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945082|NCT00965562|P1|Participant Flow|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945083|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945084|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945085|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945086|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945087|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945088|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945089|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945090|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945091|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945092|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945093|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945094|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945095|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945096|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945097|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945098|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945099|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945100|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945101|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945102|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945103|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945107|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945108|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945109|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945110|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 5 cycles, women will receive placebo.
945111|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945112|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945113|NCT00965562|O3|Outcome|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945114|NCT00965562|O2|Outcome|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945115|NCT00965562|O1|Outcome|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945116|NCT00965562|E3|Reported Event|III: Placebo|Placebo : For 4 cycles, women will receive placebo.
945117|NCT00965562|E2|Reported Event|II: Calcium|Calcium : 1200 mg of calcium to be taken for 4 menstrual cycles.
945118|NCT00965562|E1|Reported Event|I: Fluoxetine|Fluoxetine : Fluoxetine 20 mg per day for 4 menstrual cycles.
945119|NCT00965523|B1|Baseline|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
945120|NCT00965523|P1|Participant Flow|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
945121|NCT00965523|O1|Outcome|Eribulin Mesylate|Eribulin mesylate 1.4 mg/m^2 intravenous infusion given over 2 to 5 minutes on Day 1 and 8 every 21 days.
951456|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
945129|NCT00965484|B1|Baseline|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
945130|NCT00965484|P1|Participant Flow|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
945131|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
945132|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
945133|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
945134|NCT00965484|O1|Outcome|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
945135|NCT00965484|E1|Reported Event|Genotropin / Genotropin Mark VII Pen|Genotropin (somatropin) injection administered using the Genotropin Mark VII Pen subcutaneously (sc) at a dose prescribed by the physician.
945136|NCT00965458|B3|Baseline|Total|Total of all reporting groups
945137|NCT00965458|B2|Baseline|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
945138|NCT00965458|B1|Baseline|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
945139|NCT00965458|P2|Participant Flow|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945140|NCT00965458|P1|Participant Flow|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945141|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945142|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945143|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945144|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945145|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945146|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945147|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
951321|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
945148|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945149|NCT00965458|O2|Outcome|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945150|NCT00965458|O1|Outcome|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.
945151|NCT00965458|O2|Outcome|Placebo|"Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Placebo: Weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
945152|NCT00965458|O1|Outcome|Alefacept|"Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment.~Alefacept: Weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment."
945153|NCT00965458|E2|Reported Event|Placebo|Subjects in this group received weekly intramuscular injections of a placebo saline solution of equal volume to the alefacept group for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
945154|NCT00965458|E1|Reported Event|Alefacept|Subjects in this group received weekly intramuscular injections of alefacept (15 mg) for 2 cycles of 12 weeks each, separated by a 12 week pause in treatment
945155|NCT00965341|B3|Baseline|Total|Total of all reporting groups
945156|NCT00965341|B2|Baseline|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
945157|NCT00965341|B1|Baseline|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
945158|NCT00965341|P2|Participant Flow|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
945159|NCT00965341|P1|Participant Flow|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
945161|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
945162|NCT00965341|O2|Outcome|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
945163|NCT00965341|O1|Outcome|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
945164|NCT00965341|E2|Reported Event|Placebo|Starting dose of 150 mg or 200 mg sesame seed oil by injection into buttock muscle, about every 15 days through Day 72.
945165|NCT00965341|E1|Reported Event|Testosterone|Testosterone Starting dose of 150 or 200 mg testosterone enanthate/cypionate by injection into buttock muscle, every 15 days through Day 72.
945166|NCT00965250|B3|Baseline|Total|Total of all reporting groups
945167|NCT00965250|B2|Baseline|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945168|NCT00965250|B1|Baseline|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945169|NCT00965250|P2|Participant Flow|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945170|NCT00965250|P1|Participant Flow|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945171|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945172|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945173|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945174|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945175|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945176|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945177|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945178|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945179|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945180|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945181|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945182|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945183|NCT00965250|O1|Outcome|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
945184|NCT00965250|O2|Outcome|Thymic Carcinoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945185|NCT00965250|O1|Outcome|Thymoma|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks. The most common tumors of the thymus are thymomas (well differentiated neoplasms and moderately differentiated neoplasms) and thymic (poorly differentiated neoplasms) carcinomas.
945186|NCT00965250|E1|Reported Event|IMC-A12 Monotherapy in Patients|Patients will receive IMC-A12 at a dose of 20 mg/kg intravenously once every three weeks.
945187|NCT00965237|B1|Baseline|Overall Study|This reporting group includes all enrolled and dispensed subjects.
945282|NCT00964860|B2|Baseline|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
951457|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
945188|NCT00965237|P2|Participant Flow|Single Vision CL + Reading Glasses / Multifocal CL|Lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn first, with lotrafilcon B multifocal contact lenses (CL) worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
945189|NCT00965237|P1|Participant Flow|Multifocal CL / Single Vision CL+ Reading Glasses|Lotrafilcon B multifocal contact lenses (CL) worn first, with lotrafilcon B single vision contact lenses (CL) and over-reader spectacles worn second. Both contact lens products worn bilaterally on a daily wear basis; over-reader spectacles worn on an as-needed basis.
945190|NCT00965237|O2|Outcome|Lotrafilcon B Single Vision Contact Lens + Reading Glasses|Commercially marketed, lotrafilcon B, silicone hydrogel, single vision contact lenses for daily wear use, with over-reader spectacles worn as needed
945191|NCT00965237|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Commercially marketed, lotrafilcon B, silicone hydrogel, multifocal contact lens for daily wear use
945192|NCT00965237|E2|Reported Event|Single Vision Contact Lens|Commercially marketed lotrafilcon B single vision contact lenses
945193|NCT00965237|E1|Reported Event|Multifocal Contact Lens|Commercially marketed lotrafilcon B multifocal contact lenses
945194|NCT00965185|B3|Baseline|Total|Total of all reporting groups
945195|NCT00965185|B2|Baseline|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945196|NCT00965185|B1|Baseline|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945197|NCT00965185|P2|Participant Flow|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945198|NCT00965185|P1|Participant Flow|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945199|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945200|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945201|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945202|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945203|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945204|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945205|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945206|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945207|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945208|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945209|NCT00965185|O2|Outcome|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945210|NCT00965185|O1|Outcome|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945211|NCT00965185|E2|Reported Event|Placebo|Participants received 20 mg placebo given orally daily for the first three months followed by 40 mg placebo daily for the next 9 months.
945212|NCT00965185|E1|Reported Event|Atorvastatin|Participants received 20 mg atorvastatin given orally daily for the first 3 months, followed by 40 mg atorvastatin daily for the final 9 months.
945213|NCT00965146|B1|Baseline|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
945214|NCT00965146|P1|Participant Flow|Scorpio® CR Device|All subjects were implanted with the Scorpio® CR Total Knee System Study Device
945215|NCT00965146|O1|Outcome|Scorpio® CR Device|All subjects received the Scorpio® CR Device
945216|NCT00965146|E1|Reported Event|Scorpio® CR Total Knee System Study Device|All subjects were implanted with the Scorpio® CR Knee Arthroplasty Study Device
945217|NCT00965094|B3|Baseline|Total|Total of all reporting groups
945218|NCT00965094|B2|Baseline|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945219|NCT00965094|B1|Baseline|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945249|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945220|NCT00965094|P2|Participant Flow|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945221|NCT00965094|P1|Participant Flow|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945222|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945223|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945224|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945225|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945226|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945242|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
946422|NCT00962585|E3|Reported Event|S-equol 150 mg BID|300 mg total daily dose of S-equol
945227|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945228|NCT00965094|O2|Outcome|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945229|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945280|NCT00964886|E1|Reported Event|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
945230|NCT00965094|O2|Outcome|Reference Therapy|Control Arm: At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945231|NCT00965094|O1|Outcome|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945232|NCT00965094|E2|Reported Event|Reference Therapy|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients continued on the prior immunosuppressive regimen consisting of MPA + tacrolimus with corticosteroids.
945233|NCT00965094|E1|Reported Event|Everolimus|At BL1, all study patients received induction therapy with basiliximab (Simulect®; 2x20mg on day 0 - 2 hours prior to transplantation, and on day 4 after transplantation) and commenced an immunosuppressive regimen consisting of MPA (Myfortic®; target dose: 1440 mg/day, which was also the maximum daily dose) + tacrolimus (Prograf®; based on C0-h levels; Table 9-2) and with corticosteroids. AT BL2 [Month 3 (+1 week) after transplantation], eligible patients were randomized, using living and cadaveric donation as stratum. Patients were switched to the CNI-free regimen. Everolimus was added to the patients immunosuppressive regimen and tacrolimus was removed successively.
945234|NCT00965081|B3|Baseline|Total|Total of all reporting groups
945235|NCT00965081|B2|Baseline|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945236|NCT00965081|B1|Baseline|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945237|NCT00965081|P2|Participant Flow|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945238|NCT00965081|P1|Participant Flow|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945239|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945240|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945241|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945268|NCT00964886|P1|Participant Flow|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
945243|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945244|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945245|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945246|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945247|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945248|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945250|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945251|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945252|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945253|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945254|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945255|NCT00965081|O2|Outcome|Placebo|"Placebo (inactive capsules identical in appearance to duloxetine capsules) QD po at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of MDD will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945256|NCT00965081|O1|Outcome|Duloxetine|"Duloxetine 30 milligrams (mg) dose daily (QD) by mouth (po) at the same time each day for 12 weeks~Participants who enter the study with a diagnosis of major depressive disorder (MDD) will be rescued to duloxetine 60 mg QD if they meet the predefined blinded criteria for worsening of depression."
945257|NCT00965081|E3|Reported Event|Duloxetine 60 mg|Participants who enter the study with a diagnosis of major depressive disorder (MDD) and who also meet the predefined blinded criteria for worsening of depression during the acute therapy phase will be rescued to daily duloxetine 60 mg for the remainder of the acute therapy phase.
945258|NCT00965081|E2|Reported Event|Duloxetine 30 mg|Duloxetine 30 mg dose daily by mouth at the same time each day for 12 weeks
945259|NCT00965081|E1|Reported Event|Placebo|Placebo (inactive capsules identical in appearance to duloxetine capsules) daily by mouth at the same time each day for 12 weeks.
945260|NCT00964886|B5|Baseline|Total|Total of all reporting groups
945261|NCT00964886|B4|Baseline|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
945262|NCT00964886|B3|Baseline|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
945263|NCT00964886|B2|Baseline|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
945264|NCT00964886|B1|Baseline|Arm 1|"desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
945265|NCT00964886|P4|Participant Flow|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
945266|NCT00964886|P3|Participant Flow|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
945267|NCT00964886|P2|Participant Flow|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
945269|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor all participants assigned at baseline not to receive cognitive behavioral therapy
945270|NCT00964886|O1|Outcome|Arm 2 + Arm 3|Factor all participants assigned at baseline to receive cognitive behavioral therapy
945271|NCT00964886|O2|Outcome|Arm 1 + Arm 4|Factor no cognitive behavioral therapy
945272|NCT00964886|O1|Outcome|Arm 2 + Arm 3|"Factor cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
945273|NCT00964886|O2|Outcome|Arm 2 + Arm 4|Factor all participants assigned at baseline to receive benztropine mesylate (active placebo)
945274|NCT00964886|O1|Outcome|Arm 1 + Arm 3|Factor all participants assigned at baseline to receive desipramine hydrochloride
945275|NCT00964886|O2|Outcome|Arm 2 + Arm 4|"Factor anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
945276|NCT00964886|O1|Outcome|Arm 1 + Arm 3|"Factor desipramine hydrochloride~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml"
945277|NCT00964886|E4|Reported Event|Arm 4|"anticholinergic medication; active placebo~benztropine mesylate 0.125 mg daily: benztropine mesylate is a placebo, some of whose side effects mimic those of experimental intervention, desipramine hydrochloride"
945278|NCT00964886|E3|Reported Event|Arm 3|"desipramine hydrochloride and cognitive behavioral therapy~desipramine hydrochloride: desipramine hydrochloride, with dose targeted to achieve a serum concentration of 5-60ng/ml~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
945279|NCT00964886|E2|Reported Event|Arm 2|"cognitive behavioral therapy~cognitive behavioral therapy: cognitive behavioral therapy, a type of psychotherapy oriented towards restoring function and reducing impact of pain on everyday life"
945283|NCT00964860|B1|Baseline|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
945284|NCT00964860|P2|Participant Flow|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
945285|NCT00964860|P1|Participant Flow|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
945286|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
945287|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
945288|NCT00964860|O2|Outcome|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
945289|NCT00964860|O1|Outcome|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
945290|NCT00964860|E2|Reported Event|Brushing + Flossing|Brushing with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice, plus flossing with Glide floss
945291|NCT00964860|E1|Reported Event|Brushing Only|Brushing Only with an Oral B manual toothbrush and Crest Cavity Protection, sodium fluoride dentifrice
945292|NCT00964795|B1|Baseline|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
945293|NCT00964795|P1|Participant Flow|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
945294|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
945295|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
945512|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945296|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
945297|NCT00964795|O1|Outcome|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting with amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
945298|NCT00964795|E1|Reported Event|Open-label Intravitreal Aflibercept Injection|Open-label Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321) 2 mg (40 mg/mL) was administered no more frequently than every 4 weeks, but no less frequently than every 12 weeks until amendment 4. Starting from amendment 4, Intravitreal Aflibercept Injection was administered no less frequently than every 8 weeks. Within these limits, the investigator would determine the interval of Intravitreal Aflibercept Injection administration on an as-needed basis according to the protocol-suggested re-treatment criteria, however the injections must have occurred at least every 12 weeks prior to amendment 4, and at least every 8 weeks starting from amendment 4 as noted above.
945299|NCT00964743|B1|Baseline|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945522|NCT00963924|B3|Baseline|Total|Total of all reporting groups
951458|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
945300|NCT00964743|P1|Participant Flow|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945301|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945302|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945303|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945304|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945305|NCT00964743|O1|Outcome|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945306|NCT00964743|E1|Reported Event|Intrathecal DepoCyt and Oral Sorafenib|This is a single arm pilot study. Investigators planned to enroll approximately 10 patients to receive concurrent intrathecal DepoCyt and oral Sorafenib. DepoCyt: through a reservoir every 2 weeks for 5 doses, then every 4 weeks for an additional 5 doses (a total of 10 DepoCyt treatments). Oral Sorafenib: at 400 mg twice a day throughout the treatment course until disease progression or death.
945307|NCT00964678|B1|Baseline|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
945308|NCT00964678|P1|Participant Flow|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
945309|NCT00964678|O1|Outcome|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
945310|NCT00964678|O1|Outcome|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
945311|NCT00964678|O1|Outcome|Carvedilol|Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI
945995|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945312|NCT00964678|O1|Outcome|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
945313|NCT00964678|E1|Reported Event|Carvedilol|"Carvedilol is titrated from a dose of 3.125mg twice daily to a maximal dose of 25mg twice daily over 24 weeks. Patients are evaluated to their response with 6 minute walk testing, echocardiography, and cardiac MRI~Carvedilol: twice daily oral treatment in escalating dose"
945314|NCT00964548|B3|Baseline|Total|Total of all reporting groups
945315|NCT00964548|B2|Baseline|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
945316|NCT00964548|B1|Baseline|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
945317|NCT00964548|P2|Participant Flow|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
945318|NCT00964548|P1|Participant Flow|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
945319|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
945320|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
945321|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
945322|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
945323|NCT00964548|O2|Outcome|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
945324|NCT00964548|O1|Outcome|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
945325|NCT00964548|E2|Reported Event|Dantrolene (High Dose)|Single dose of Dantrolene 2.5 mg/kg infused over 60 min.
945326|NCT00964548|E1|Reported Event|Dantrolene (Low Dose)|Single dose of Dantrolene 1.25 mg/kg infused over 60 min.
945327|NCT00964496|B3|Baseline|Total|Total of all reporting groups
945328|NCT00964496|B2|Baseline|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945329|NCT00964496|B1|Baseline|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945330|NCT00964496|P2|Participant Flow|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945331|NCT00964496|P1|Participant Flow|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945332|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945333|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945334|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945335|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945336|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945337|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945338|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945339|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945340|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945341|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945342|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945343|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945344|NCT00964496|O2|Outcome|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945345|NCT00964496|O1|Outcome|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945346|NCT00964496|E2|Reported Event|Iron-controlled Group|interventions administered (dosage, 400mg; dosage form, 100mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945347|NCT00964496|E1|Reported Event|Thalidomide Group|interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 4 times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m)
945348|NCT00964444|B1|Baseline|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
945349|NCT00964444|P1|Participant Flow|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
945350|NCT00964444|O1|Outcome|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
945351|NCT00964444|E1|Reported Event|Delivery Force Study Patients|This observational study consisted of a single group of patients in active labor. The device was used to measure the force of delivering the baby. All calculations were done after the delivery was completed. Since this was an observational study, the clinical care providers did not receive the results while the patient was in the delivery suite.
945352|NCT00964431|B5|Baseline|Total|Total of all reporting groups
945353|NCT00964431|B4|Baseline|Placebo|
945354|NCT00964431|B3|Baseline|Celecoxib 400 mg|
945355|NCT00964431|B2|Baseline|Indomethacin Test (Upper Dose)|Single dose
945356|NCT00964431|B1|Baseline|Indomethacin Test (Lower Dose)|
945357|NCT00964431|P4|Participant Flow|Placebo|
945358|NCT00964431|P3|Participant Flow|Celecoxib 400 mg|
945359|NCT00964431|P2|Participant Flow|Indomethacin Test (Upper Dose)|Single dose
945360|NCT00964431|P1|Participant Flow|Indomethacin Test (Lower Dose)|
945361|NCT00964431|O4|Outcome|Placebo|
945362|NCT00964431|O3|Outcome|Celecoxib 400 mg|
945363|NCT00964431|O2|Outcome|Indomethacin Test (Upper Dose)|40-mg
945364|NCT00964431|O1|Outcome|Indomethacin Test (Lower Dose)|20-mg
945365|NCT00964431|E4|Reported Event|Placebo|
945366|NCT00964431|E3|Reported Event|Celecoxib 400 mg|
945367|NCT00964431|E2|Reported Event|Indomethacin Test (Upper Dose)|Single dose
945368|NCT00964431|E1|Reported Event|Indomethacin Test (Lower Dose)|
945369|NCT00964392|B3|Baseline|Total|Total of all reporting groups
945370|NCT00964392|B2|Baseline|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
945371|NCT00964392|B1|Baseline|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
945372|NCT00964392|P2|Participant Flow|Less-Experienced Physicians (LEP)|LEP are defined as those who have performed less than or equal to 50 AF ablations per year.
945373|NCT00964392|P1|Participant Flow|More-Experienced Physicians (MEP)|MEP are defined as those who have performed greater than 50 AF ablation cases per year.
945374|NCT00964392|O2|Outcome|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
945375|NCT00964392|O1|Outcome|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
945376|NCT00964392|O2|Outcome|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
945377|NCT00964392|O1|Outcome|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
945378|NCT00964392|E2|Reported Event|Less-experienced Physicians|Subjects were enrolled into sites where the primary investigators were less-experienced physicians (LEP). Those physicians were prospectively classified into the LEP group if he or she had performed less than or equal to 50 atrial fibrillation (AF) ablation procedures per year.
945379|NCT00964392|E1|Reported Event|More-experienced Physicians|Subjects were enrolled into sites where the primary investigators were more-experienced physicians (MEP). Those physicians were prospectively classified into the MEP group if he or she had performed greater than 50 atrial fibrillation (AF) ablation procedures per year.
945380|NCT00964366|B3|Baseline|Total|Total of all reporting groups
945381|NCT00964366|B2|Baseline|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945382|NCT00964366|B1|Baseline|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945383|NCT00964366|P2|Participant Flow|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945384|NCT00964366|P1|Participant Flow|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945385|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945386|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945387|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945388|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945389|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945390|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945391|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945523|NCT00963924|B2|Baseline|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
945392|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945393|NCT00964366|O2|Outcome|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945394|NCT00964366|O1|Outcome|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945395|NCT00964366|E2|Reported Event|Dapsone Gel|Twice-daily applications of dapsone gel to one-half of the face. Dapsone facial gel was applied twice daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945396|NCT00964366|E1|Reported Event|Clindamycin and BPO Gel|Daily applications of Clindamycin and benzoyl peroxide gel to one-half of the face. Clindamycin and benzoyl peroxide facial gel was applied daily to one side of the face of all subjects in this group in a split-face model. On weekdays during the two-week trial, the investigator scored Erythema on a scale of 0 (none) to 8 (severe) and Dryness on a scale of 0 (none) to 8 (severe).
945397|NCT00964223|B1|Baseline|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945398|NCT00964223|P1|Participant Flow|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945399|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945400|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945401|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945402|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945403|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945404|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945405|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945406|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945407|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945408|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945409|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945410|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945411|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945412|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945413|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945414|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945415|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945416|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945417|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945418|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945419|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945420|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945421|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
951322|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
945422|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945423|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945424|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945425|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945426|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945427|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945428|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945429|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945430|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945431|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945432|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945433|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945434|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945435|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945436|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945437|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945438|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945439|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
951323|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
945440|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945441|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945442|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945443|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945444|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945445|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945446|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945447|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945448|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945449|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945450|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945451|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945452|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945453|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945454|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945455|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945456|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945457|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
946423|NCT00962585|E2|Reported Event|S-equol 50 mg BID|100 mg total daily dose of S-equol
945458|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945459|NCT00964223|O2|Outcome|Epiduo Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945460|NCT00964223|O1|Outcome|Duac Gel|Starting at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945461|NCT00964223|E1|Reported Event|All Study Participants|Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl peroxide and benzoyl peroxide/adapalene gel in a bilateral split-face fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the entire face for an additional 6 weeks.
945462|NCT00964119|B1|Baseline|Single Cohort Observational|
945463|NCT00964119|P1|Participant Flow|Single Cohort Obervational|
945464|NCT00964119|O1|Outcome|Single Cohort Observational|
945465|NCT00964119|E1|Reported Event|Single Cohort Observational|
945466|NCT00964028|B3|Baseline|Total|Total of all reporting groups
945467|NCT00964028|B2|Baseline|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
945468|NCT00964028|B1|Baseline|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
945469|NCT00964028|P2|Participant Flow|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
945470|NCT00964028|P1|Participant Flow|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
945471|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
945472|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
945473|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
945474|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
945475|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
945476|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
945477|NCT00964028|O2|Outcome|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
945478|NCT00964028|O1|Outcome|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
945479|NCT00964028|E2|Reported Event|Infanrix-IPV/Hib M3-M4-M5 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age (M3-M4-M5), administered intramuscularly into the upper right side of the thigh.
945480|NCT00964028|E1|Reported Event|Infanrix-IPV/Hib M2-M3-M4 Group|Healthy male or female subjects between and including 60 and 90 days of age at the time of the first vaccination, received 3 doses of Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age (M2-M3-M4), administered intramuscularly into the upper right side of the thigh.
945481|NCT00963937|B4|Baseline|Total|Total of all reporting groups
945482|NCT00963937|B3|Baseline|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945483|NCT00963937|B2|Baseline|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
951324|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
945484|NCT00963937|B1|Baseline|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945485|NCT00963937|P3|Participant Flow|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945486|NCT00963937|P2|Participant Flow|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945487|NCT00963937|P1|Participant Flow|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945488|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945489|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945490|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945491|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945492|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945493|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945494|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945495|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945496|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945497|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945498|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945499|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945500|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945501|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945502|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945503|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945504|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945505|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945506|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945507|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945508|NCT00963937|O4|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945509|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945510|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945511|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945513|NCT00963937|O3|Outcome|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945514|NCT00963937|O2|Outcome|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945515|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945516|NCT00963937|O2|Outcome|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945517|NCT00963937|O1|Outcome|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945518|NCT00963937|E4|Reported Event|Sumatriptan Pooled|All participants receiving either sumatriptan 25 mg or 50 mg
945519|NCT00963937|E3|Reported Event|Sumatriptan 50 mg|Participants took 2 tablets of sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945520|NCT00963937|E2|Reported Event|Sumatriptan 25 mg|Participants took 1 tablet of sumatriptan 25 mg and 1 tablet of placebo matched to sumatriptan 25 mg within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on the 5-grade scale.
945521|NCT00963937|E1|Reported Event|Placebo|Participants took 2 tablets of placebo matched to sumatriptan 25 milligrams (mg) within 30 minutes after the development of a migraine associated with a score of 3 or more for pain on a 5-grade, self-rating scale to assess the pain intensity of a migraine: 1 = none, 2 = mild, 3 = mild to moderate, 4 = moderate to severe, and 5 = severe.
945524|NCT00963924|B1|Baseline|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
945525|NCT00963924|P2|Participant Flow|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
945526|NCT00963924|P1|Participant Flow|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
945527|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945528|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945529|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945530|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945531|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945532|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945533|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945534|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945535|NCT00963924|O2|Outcome|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945536|NCT00963924|O1|Outcome|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945537|NCT00963924|O2|Outcome|Placebo|Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
951325|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
945538|NCT00963924|O1|Outcome|D-cycloserine|Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.
945539|NCT00963924|E2|Reported Event|Placebo|"Participants will receive placebo weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~Placebo: Placebo by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945540|NCT00963924|E1|Reported Event|D-cycloserine|"Participants will receive D-cycloserine weekly, one hour before the first cognitive remediation session of the week, for eight weeks.~D-cycloserine: 50 mg by mouth one hour before first cognitive remediation session each week for eight weeks.~Cognitive Remediation: 40 one-hour daily sessions of cognitive remediation (Brain Fitness Program) over eight weeks."
945541|NCT00963872|B3|Baseline|Total|Total of all reporting groups
945542|NCT00963872|B2|Baseline|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945543|NCT00963872|B1|Baseline|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945544|NCT00963872|P2|Participant Flow|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945545|NCT00963872|P1|Participant Flow|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945546|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945547|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945548|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945888|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945549|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945550|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945551|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945552|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945553|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945554|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945555|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945556|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945557|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945558|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945559|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945560|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945561|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945562|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945563|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945564|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945565|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945566|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945567|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945568|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945569|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945570|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945571|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
946424|NCT00962585|E1|Reported Event|S-equol 10 mg BID|20 mg total daily dose of S-equol
945572|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945573|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945574|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945575|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945576|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945577|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945578|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945579|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945580|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945581|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945582|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945583|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945584|NCT00963872|O2|Outcome|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945585|NCT00963872|O1|Outcome|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945586|NCT00963872|E2|Reported Event|Complement Fragment A - Larger Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the larger cell dose.
945587|NCT00963872|E1|Reported Event|Complement Fragment 3A - Small Cell Dose|Patients who received complement fragment 3a (C3a) priming of the UCB unit with the smaller cell dose following preparation regimen and radiation.
945588|NCT00963859|B1|Baseline|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
945589|NCT00963859|P1|Participant Flow|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
945590|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
945591|NCT00963859|O1|Outcome|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
945592|NCT00963859|E1|Reported Event|Robotic-assisted Laparoscopic Surgery|Robotic-assisted laparoscopic extended pelvic lymph node dissection
945593|NCT00963820|B1|Baseline|Overall Study|Safety Population
945594|NCT00963820|P12|Participant Flow|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945595|NCT00963820|P11|Participant Flow|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945596|NCT00963820|P10|Participant Flow|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945597|NCT00963820|P9|Participant Flow|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established Maximum Tolerated Dose (MTD), capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945598|NCT00963820|P8|Participant Flow|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945599|NCT00963820|P7|Participant Flow|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945600|NCT00963820|P6|Participant Flow|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945601|NCT00963820|P5|Participant Flow|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945602|NCT00963820|P4|Participant Flow|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
946425|NCT00962390|B5|Baseline|Total|Total of all reporting groups
945603|NCT00963820|P3|Participant Flow|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945604|NCT00963820|P2|Participant Flow|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945605|NCT00963820|P1|Participant Flow|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945606|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945607|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945608|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945609|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
946364|NCT00962585|B1|Baseline|S-equol 10 mg BID|20 mg total daily dose of S-equol
945610|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945611|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945612|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945613|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945614|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945615|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945616|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945617|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945618|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945619|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945620|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945621|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945622|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945623|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945624|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945793|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945625|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945626|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945627|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945628|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945629|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945630|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945631|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945701|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945632|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945633|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945634|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945635|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945636|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945637|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945638|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945639|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945640|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945641|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945642|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945643|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945644|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945645|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945646|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945647|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945648|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945649|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945650|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945651|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945652|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945653|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945654|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945655|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945656|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945657|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945658|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945659|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945660|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945661|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945662|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945663|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945664|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945665|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945666|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945667|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945668|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945669|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945670|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945671|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945672|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945673|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945674|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945675|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945676|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945677|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
946365|NCT00962585|P4|Participant Flow|Placebo|Placebo treatment arm
945678|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945679|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945680|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945681|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945682|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945683|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945684|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945685|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945686|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945687|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945688|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945689|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945690|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945691|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945692|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945693|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945694|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945695|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945696|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945697|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945698|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945699|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945700|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945702|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945703|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945704|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945705|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945706|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945707|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945708|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945709|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945710|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945711|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945712|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945713|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945714|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945715|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945716|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
946549|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
945717|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945718|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945719|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945720|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945721|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945722|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945723|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945762|NCT00963638|B1|Baseline|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
945724|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945725|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945726|NCT00963820|O12|Outcome|Carfilzomib|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the expansion cohort of participants who received their last dose of carfilzomib between 21 and 60 days prior to the first dose of ixazomib citrate. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945727|NCT00963820|O11|Outcome|PI naïve|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in expansion cohort of participants who were proteasome inhibitor-naïve (PI naïve). All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945728|NCT00963820|O10|Outcome|VELCADE-relapsed (VR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the VELCADE-relapsed (VR) expansion cohort that includes 1 participant from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945729|NCT00963820|O9|Outcome|Relapsed and Refractory (RR)|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Relapsed and Refractory (RR) expansion cohort that includes 2 participants from the dose escalation cohort 2.97 mg/m^2. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945730|NCT00963820|O8|Outcome|3.95 mg/m^2|Ixazomib citrate, 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945731|NCT00963820|O7|Outcome|2.97 mg/m^2|Ixazomib citrate, 2.97 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945732|NCT00963820|O6|Outcome|2.23 mg/m^2|Ixazomib citrate, 2.23 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945733|NCT00963820|O5|Outcome|1.68 mg/m^2|Ixazomib citrate, 1.68 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945734|NCT00963820|O4|Outcome|1.20 mg/m^2|Ixazomib citrate, 1.20 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945735|NCT00963820|O3|Outcome|0.80 mg/m^2|Ixazomib citrate, 0.80 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945736|NCT00963820|O2|Outcome|0.48 mg/m^2|Ixazomib citrate, 0.48 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945737|NCT00963820|O1|Outcome|0.24 mg/m^2|Ixazomib citrate, 0.24 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the dose escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945738|NCT00963820|E2|Reported Event|Expansion Cohorts|Ixazomib citrate, 2.97 mg/m^2 established MTD, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Expansion Period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945739|NCT00963820|E1|Reported Event|Dose Escalation Cohorts|Ixazomib citrate, 0.24 to 3.95 mg/m^2, capsules, orally, once weekly on Days 1, 8, and 15 of a 28-day cycle in the Dose Escalation period. All dose amounts are expressed as the dose of ixazomib, the biologically active moiety of ixazomib citrate.
945794|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945740|NCT00963807|B1|Baseline|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
945741|NCT00963807|P1|Participant Flow|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
945763|NCT00963638|P2|Participant Flow|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
945764|NCT00963638|P1|Participant Flow|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
945765|NCT00963638|O2|Outcome|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
945766|NCT00963638|O1|Outcome|Magnesium Tablet SR (MagTabSR)|MagTabSR is 168mg taken 2 times per day for 30 days
945767|NCT00963638|E2|Reported Event|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
945742|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
945743|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
945744|NCT00963807|O2|Outcome|Non-Responders|RECIST non-responders based on CT measurements performed after 2 cycles of neoadjuvant therapy
945745|NCT00963807|O1|Outcome|Responders|RECIST responders based on CT measurements performed after 2 cycles of neoadjuvant therapy.
945746|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
945747|NCT00963807|O1|Outcome|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
945748|NCT00963807|E1|Reported Event|Treatment (Docetaxel, Cisplatin, Dexamethasone, and Surgery)|"Patients receive docetaxel IV and cisplatin IV on day 1 and dexamethasone PO BID. Treatment repeats every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT, FLT PET/CT, and thoracic CT at baseline and the end of courses 1 and 2 and then undergo surgery.~Cisplatin: Given IV~Computed Tomography: Undergo FDG PET/CT, FLT PET/CT and thoracic CT~Dexamethasone: Given PO~Docetaxel: Given IV~Fludeoxyglucose F-18: Undergo FDG PET/CT~Fluorothymidine F-18: Undergo FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies~Positron Emission Tomography: Undergo FDG PET/CT and FLT PET/CT~Therapeutic Conventional Surgery: Undergo surgery"
945749|NCT00963677|B3|Baseline|Total|Total of all reporting groups
945750|NCT00963677|B2|Baseline|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
945751|NCT00963677|B1|Baseline|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
945752|NCT00963677|P2|Participant Flow|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
945753|NCT00963677|P1|Participant Flow|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
945754|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
945755|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
945756|NCT00963677|O2|Outcome|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
945757|NCT00963677|O1|Outcome|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
945758|NCT00963677|E2|Reported Event|Difficult Intubation|The patients will be anticipated for difficult intubation without difficult ventilation. Anesthesia was induced by inhaled sevoflurane with oxygen followed by 0.3mg/kg etomidate and 1-2mg/kg succinylcholine. After induction, nasotracheal inbutation were performed with seeing optical shikani.
945759|NCT00963677|E1|Reported Event|Intubation Without Difficulty|Patients without anticipated difficult intubation. Anesthesia induction: Midalozlam, Fentanyl, Vecuronium; Etomidate. After that, nasotracheal intubation with Shikani optical stylet
945760|NCT00963638|B3|Baseline|Total|Total of all reporting groups
945761|NCT00963638|B2|Baseline|Sugar Pill|Sugar pill is taken 2 times per day for 30 days
946366|NCT00962585|P3|Participant Flow|S-equol 150 mg BID|300 mg total daily dose of S-equol
945770|NCT00963599|B4|Baseline|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945771|NCT00963599|B3|Baseline|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945772|NCT00963599|B2|Baseline|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945773|NCT00963599|B1|Baseline|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945774|NCT00963599|P4|Participant Flow|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945775|NCT00963599|P3|Participant Flow|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945776|NCT00963599|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945777|NCT00963599|P1|Participant Flow|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945778|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945779|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945780|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945781|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945782|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945783|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945784|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945785|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945786|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945787|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945788|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945789|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945790|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945791|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945792|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
946550|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
945795|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945796|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945797|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945798|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945799|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945800|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945801|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945802|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945803|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945804|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945889|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945805|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945806|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945807|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945808|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945809|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945810|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945811|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945812|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945813|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945814|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945815|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945816|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945817|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945818|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945819|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945820|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945821|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945822|NCT00963599|O4|Outcome|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945823|NCT00963599|O3|Outcome|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945824|NCT00963599|O2|Outcome|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945825|NCT00963599|O1|Outcome|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945826|NCT00963599|E4|Reported Event|Montelukast/Loratadine|Montelukast 10 mg/loratadine 10 mg combination tablet and matching-image placebo tablet to each of montelukast and loratadine orally once daily at bedtime for 2 weeks
945827|NCT00963599|E3|Reported Event|Loratadine|Loratadine 10 mg tablet and matching-image placebo tablet to each of montelukast and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945828|NCT00963599|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and matching-image placebo tablet to each of loratadine and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
951326|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
945829|NCT00963599|E1|Reported Event|Placebo|Matching-image placebo tablet to each of montelukast, loratadine, and montelukast/loratadine combination orally once daily at bedtime for 2 weeks
945830|NCT00963560|B4|Baseline|Total|Total of all reporting groups
945831|NCT00963560|B3|Baseline|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
945832|NCT00963560|B2|Baseline|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
945833|NCT00963560|B1|Baseline|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
945834|NCT00963560|P3|Participant Flow|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
945835|NCT00963560|P2|Participant Flow|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
945836|NCT00963560|P1|Participant Flow|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
945837|NCT00963560|O3|Outcome|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
945838|NCT00963560|O2|Outcome|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
945839|NCT00963560|O1|Outcome|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
945840|NCT00963560|E3|Reported Event|Crystalens AO|Bilateral implantation of Crystalens AO Intraocular Lens (IOL)
945841|NCT00963560|E2|Reported Event|Crystalens HD|Bilateral implantation of Crystalens HD Intraocular Lens (IOL)
945842|NCT00963560|E1|Reported Event|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lens (IOL)
945843|NCT00963508|B3|Baseline|Total|Total of all reporting groups
945844|NCT00963508|B2|Baseline|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
945845|NCT00963508|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
945846|NCT00963508|P2|Participant Flow|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
945847|NCT00963508|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
945848|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
945849|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
945850|NCT00963508|O2|Outcome|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
945851|NCT00963508|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
945852|NCT00963508|E2|Reported Event|Nix Crème Rinse|"Nix Crème Rinse applied to scalp for 10 minutes~Permethrin 1% rinse (Nix Crème): Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head head lice are still present."
945853|NCT00963508|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
945854|NCT00963482|B3|Baseline|Total|Total of all reporting groups
945855|NCT00963482|B2|Baseline|Control Group|Autogenic training
945856|NCT00963482|B1|Baseline|Intervention Group|Cognitive-behavioural smoking cessation program
945857|NCT00963482|P2|Participant Flow|Control Group|Autogenic training
945858|NCT00963482|P1|Participant Flow|Intervention Group|Cognitive-behavioural smoking cessation program
945859|NCT00963482|O2|Outcome|Control Group|Autogenic training
945860|NCT00963482|O1|Outcome|Intervention Group|Cognitive-behavioural smoking cessation program
945861|NCT00963482|E2|Reported Event|Control Group|Autogenic training
945862|NCT00963482|E1|Reported Event|Intervention Group|Cognitive-behavioural smoking cessation program
945863|NCT00963469|B4|Baseline|Total|Total of all reporting groups
945864|NCT00963469|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945865|NCT00963469|B2|Baseline|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945866|NCT00963469|B1|Baseline|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945867|NCT00963469|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945868|NCT00963469|P2|Participant Flow|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945869|NCT00963469|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945870|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945871|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945872|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945873|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945874|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945875|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945876|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945877|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945878|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945879|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945880|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945881|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945882|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945883|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945884|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945885|NCT00963469|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945886|NCT00963469|O2|Outcome|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945887|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945890|NCT00963469|O1|Outcome|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945891|NCT00963469|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10-mg tablet orally once daily in the morning for 4 weeks
945892|NCT00963469|E2|Reported Event|Montelukast|Montelukast 10-mg tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945893|NCT00963469|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet and Loratadine matching-image placebo tablet orally once daily in the morning for 4 weeks
945894|NCT00963430|B3|Baseline|Total|Total of all reporting groups
945895|NCT00963430|B2|Baseline|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945896|NCT00963430|B1|Baseline|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945897|NCT00963430|P2|Participant Flow|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945898|NCT00963430|P1|Participant Flow|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945899|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945900|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945901|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945902|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945903|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945904|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945905|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945906|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945907|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945908|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945909|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945910|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945911|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945912|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945913|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945914|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945915|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945916|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945917|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945918|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945919|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945920|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945921|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945922|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945923|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945924|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945925|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945926|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945927|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945928|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945929|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945930|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945931|NCT00963430|O2|Outcome|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945932|NCT00963430|O1|Outcome|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945933|NCT00963430|E2|Reported Event|30 Mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945934|NCT00963430|E1|Reported Event|15 Mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
945935|NCT00963235|B1|Baseline|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945936|NCT00963235|P1|Participant Flow|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945937|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945938|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945939|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945940|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945941|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945942|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945943|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945944|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945945|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945946|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945947|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945948|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945949|NCT00963235|O1|Outcome|13vPnC|Participants previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly, 6 months apart.
945950|NCT00963235|E4|Reported Event|13vPnC (After Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received at least 1 of the 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from the blood draw 28 to 42 days post-13vPnC Dose 3 up to 6-month follow-up.
945993|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945994|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945951|NCT00963235|E3|Reported Event|13vPnC (After Dose 3 and Before Dose 3 Blood Draw)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 3 to prior to the blood draw 28 to 42 days post-13vPnC Dose 3.
945952|NCT00963235|E2|Reported Event|13vPnC (After Dose 2 and Before Dose 3)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 2 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 6 months apart and were assessed from 13vPnC Dose 2 prior to administration of 13vPnC Dose 3.
945953|NCT00963235|E1|Reported Event|13vPnC (After Dose 1 and Before Dose 2)|Participants who were previously immunized with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS), received 1 dose of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly and were assessed from 13vPnC Dose 1 to prior to administration of 13vPnC Dose 2.
945954|NCT00963157|B6|Baseline|Total|Total of all reporting groups
945955|NCT00963157|B5|Baseline|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945956|NCT00963157|B4|Baseline|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945957|NCT00963157|B3|Baseline|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945958|NCT00963157|B2|Baseline|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945959|NCT00963157|B1|Baseline|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945960|NCT00963157|P5|Participant Flow|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945961|NCT00963157|P4|Participant Flow|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945962|NCT00963157|P3|Participant Flow|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945963|NCT00963157|P2|Participant Flow|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945964|NCT00963157|P1|Participant Flow|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945965|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945966|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945967|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945968|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945969|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945970|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945971|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945972|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945973|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945974|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945975|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945976|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945977|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945978|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945979|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945980|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945981|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945982|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945983|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945984|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945985|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945986|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945987|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945988|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945989|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945990|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945991|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945992|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945996|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945997|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
945998|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
945999|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946000|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946001|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946002|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946003|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946004|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946005|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946006|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946007|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946008|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946009|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946010|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946011|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946012|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946013|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946014|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946015|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946016|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946017|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946018|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946019|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946020|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946021|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946022|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946023|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946024|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946025|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946026|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946027|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946028|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946029|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946030|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946031|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946032|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946033|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946034|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946035|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946036|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946037|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946038|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946039|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946040|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946041|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
951327|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
946042|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946043|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946044|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946045|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946046|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946047|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946048|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946049|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946050|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946051|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946052|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946053|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946054|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946055|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946056|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946057|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946058|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946059|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946060|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946061|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946062|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946063|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946064|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946065|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946066|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946067|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946068|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946069|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946070|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946071|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946072|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946073|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946074|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946075|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946076|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946077|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946078|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946079|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946080|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946081|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946082|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946083|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946084|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946085|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946086|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946087|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
951328|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
946088|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946089|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946090|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946091|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946092|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946093|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946094|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946095|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946096|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946097|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946098|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946099|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946100|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946101|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946102|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946103|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946104|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946105|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946106|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946107|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946108|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946109|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946110|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946111|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946112|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946113|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946114|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946115|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946116|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946117|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946118|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946119|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946120|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946121|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946122|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946123|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946124|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946125|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946126|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946127|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946128|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946129|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946130|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946131|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946132|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946133|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
951329|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
946134|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946135|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946136|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946137|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946138|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946139|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946140|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946141|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946142|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946143|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946144|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946145|NCT00963157|O5|Outcome|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946146|NCT00963157|O4|Outcome|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946147|NCT00963157|O3|Outcome|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946148|NCT00963157|O2|Outcome|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946149|NCT00963157|O1|Outcome|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946150|NCT00963157|E5|Reported Event|15 mcg H1N1 Vaccine Unadjuvanted|Participants received 15 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946151|NCT00963157|E4|Reported Event|15 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 15 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946152|NCT00963157|E3|Reported Event|7.5 mcg H1N1 Vaccine Unadjuvanted|Participants received 7.5 mcg H1N1 vaccine unadjuvanted on Day 0 and Day 21.
946153|NCT00963157|E2|Reported Event|7.5 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 7.5 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946154|NCT00963157|E1|Reported Event|3.75 mcg H1N1 Vaccine + AS03 Adjuvant|Participants received 3.75 mcg H1N1 vaccine plus AS03 adjuvant on Day 0 and Day 21.
946155|NCT00962871|B5|Baseline|Total|Total of all reporting groups
946156|NCT00962871|B4|Baseline|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
946157|NCT00962871|B3|Baseline|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946158|NCT00962871|B2|Baseline|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946159|NCT00962871|B1|Baseline|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946160|NCT00962871|P4|Participant Flow|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
946161|NCT00962871|P3|Participant Flow|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946162|NCT00962871|P2|Participant Flow|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946163|NCT00962871|P1|Participant Flow|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946164|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
946165|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946166|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946167|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946168|NCT00962871|O4|Outcome|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
946169|NCT00962871|O3|Outcome|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946193|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946170|NCT00962871|O2|Outcome|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946171|NCT00962871|O1|Outcome|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946172|NCT00962871|E4|Reported Event|Delayed Treatment|Each participant received PEG-IFN alfa-2a, 360 μg/week after an initial 2-week delay.
946173|NCT00962871|E3|Reported Event|PEG-IFN Alfa-2a 360 μg|Each participant received Peginterferon alfa-2a, 360 µg subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946174|NCT00962871|E2|Reported Event|Tenofovir 300 mg + PEG-IFN Alfa-2a 360 μg|Each participant received Tenofovir 300 mg once a day and Peginterferon alfa-2a (PEG-IFN alfa-2a), 360 micrograms (µg) subcutaneously once a week for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946175|NCT00962871|E1|Reported Event|Tenofovir 300 mg|Each participant received Tenofovir 300 mg once a day for 2 weeks and thereafter received an optional treatment of Peginterferon alfa-2a (PEG-IFN alfa-2a) 180 µg after 2 weeks of initial treatment.
946176|NCT00962780|B3|Baseline|Total|Total of all reporting groups
946177|NCT00962780|B2|Baseline|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946200|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
951459|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
946178|NCT00962780|B1|Baseline|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946179|NCT00962780|P2|Participant Flow|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946180|NCT00962780|P1|Participant Flow|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946181|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946182|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946183|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946184|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946185|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946186|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946187|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946188|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946189|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946190|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946191|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946192|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946282|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946194|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946195|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946196|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946197|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946198|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946199|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946367|NCT00962585|P2|Participant Flow|S-equol 50 mg BID|100 mg total daily dose of S-equol
946201|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946202|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946203|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946204|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946205|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946206|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946207|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946208|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946209|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946210|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946211|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946212|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946213|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946214|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946215|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946283|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946216|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946217|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946218|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946219|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946220|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946221|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946249|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in the fluid balance chart data (masked)
946250|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|physician has insight in (full access to) the fluid balance chart data
946222|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946223|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946224|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946225|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946226|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946227|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946228|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946229|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946230|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946231|NCT00962780|O3|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946232|NCT00962780|O2|Outcome|13vPnC, 23vPS (Adult Participants)|Participants >=18 years of age (adult participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946233|NCT00962780|O1|Outcome|13vPnC, 23vPS (Pediatric Participants)|Participants older than or equal to [>=] 6 to less than [<] 18 years of age (pediatric participants) received 3 doses of 0.5 milliliter (mL) of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23-valent pneumococcal polysaccharide vaccine (23vPS) intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946234|NCT00962780|O1|Outcome|13vPnC, 23vPS (All Participants)|Participants >=6 years of age (all participants) received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose).
946235|NCT00962780|E6|Reported Event|Follow-up|Participants >=6 years of age (all participants) who received 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed from 23vPS blood draw to the 6-month follow-up telephone contact after 13vPnC Dose 3.
946236|NCT00962780|E5|Reported Event|23vPS Dose|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between 23vPS Dose and before 23vPS Dose blood draw 1 month after 23vPS Dose.
946237|NCT00962780|E4|Reported Event|13vPnC Dose 3|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 2 (13vPnC Dose 3), assessed between 13vPnC Dose 3 and before 23vPS Dose.
946414|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946238|NCT00962780|E3|Reported Event|13vPnC Dose 2|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly 1 month after 13vPnC Dose 1 (13vPnC Dose 2), assessed between 13vPnC Dose 2 and before 13vPnC Dose 3.
946239|NCT00962780|E2|Reported Event|13vPnC Dose 1|Participants >=6 years of age (all participants) who received a single dose of 0.5 mL of 13vPnC intramuscularly on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose 2.
946240|NCT00962780|E1|Reported Event|Prior 13vPnC Dose 1|Participants >=6 years of age (all participants) who received at least 1 of 3 doses of 0.5 mL of 13vPnC intramuscularly 1 month apart, followed by 1 dose of 0.5 mL of 23vPS intramuscularly 1 month after 13vPnC Dose 3 (23vPS Dose), assessed between signing of informed consent form and before 13vPnC Dose 1.
946241|NCT00962754|B3|Baseline|Total|Total of all reporting groups
946242|NCT00962754|B2|Baseline|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance data (fluid balance chart is blinded)
946243|NCT00962754|B1|Baseline|Physician Insight Fluid Balance|physician has insight in the fluid balance data
946244|NCT00962754|P2|Participant Flow|Physician no Insight Fluid Balance Chart|physician does not have insight in the fluid balance chart
946245|NCT00962754|P1|Participant Flow|Physician Insight Fluid Balance|Physician has insight in the fluid balance chart
946246|NCT00962754|O2|Outcome|Physician no Insight Fluid Balance Chart|physician has no insight in the fluid balance data (masked)
946247|NCT00962754|O1|Outcome|Physician Insight Fluid Balance|Physician has insight (full access to) in the fluid balance chart data
946248|NCT00962754|O2|Outcome|Control Group (Insight in Fluid Balance)|Physician has insight in (full access to) the fluid balance chart data
946251|NCT00962754|O1|Outcome|Intervention Group (no Insight in Fluid Balance)|physician has no insight in fluid balance chart, ie the fluid balance chart is masked
946252|NCT00962754|E2|Reported Event|Physician no Insight Fluid Balance Chart|Physician has no insight in the fluid balance chart data (masked)
946253|NCT00962754|E1|Reported Event|Physician Insight Fluid Balance|physician has insight in (full access to) the fluid balance chart data
946254|NCT00962741|B1|Baseline|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946255|NCT00962741|P1|Participant Flow|Etanercept|Etanercept was administered 0.8 milligram/kilogram (mg/kg) up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946256|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946257|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946258|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946259|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946260|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946261|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946262|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946263|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946264|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946265|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946266|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946267|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946268|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946269|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946270|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946271|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946272|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946273|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946274|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946275|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946276|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946277|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946278|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946279|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946280|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946281|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946284|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946285|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946286|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946287|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946288|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946289|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946290|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946291|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946292|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946293|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946294|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946295|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946296|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946297|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946298|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946299|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946300|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946301|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946302|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946303|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946304|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946305|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946306|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946307|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946308|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946309|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946310|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946311|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946312|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946313|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946314|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946315|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946316|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946317|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946318|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946319|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946320|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946321|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946322|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946323|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946324|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946325|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946326|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946327|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946328|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946329|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946330|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946331|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946332|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946333|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946334|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946335|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946336|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946337|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946338|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946339|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946340|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946341|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946342|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946343|NCT00962741|O1|Outcome|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946344|NCT00962741|E1|Reported Event|Etanercept|Etanercept was administered 0.8 mg/kg up to a maximum dose of 50 mg once weekly subcutaneously for 96 weeks.
946345|NCT00962650|B1|Baseline|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
946346|NCT00962650|P1|Participant Flow|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
946347|NCT00962650|O1|Outcome|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
946348|NCT00962650|E1|Reported Event|Natural Orifice Transgastric Diagnostic Peritineoscopy|Natural orifice transgastric diagnostic peritineoscopy refers to performing diagnostic peritineoscopy with laparoscopic assistance with access through the stomach instead of using a trocar placed through the skin.
946349|NCT00962598|B3|Baseline|Total|Total of all reporting groups
946350|NCT00962598|B2|Baseline|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
946351|NCT00962598|B1|Baseline|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
946352|NCT00962598|P2|Participant Flow|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
946353|NCT00962598|P1|Participant Flow|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
946354|NCT00962598|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
946355|NCT00962598|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
946415|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946416|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946417|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946418|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946419|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946420|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946356|NCT00962598|O2|Outcome|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
946357|NCT00962598|O1|Outcome|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
946358|NCT00962598|E2|Reported Event|Omega-3 Fatty Acids|"The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d.~Omega 3 Fatty Acids: The study medication will consist of combined EPA/DHA with a ratio of 2:1. Dosage will be titrated based on clinical response and side effects. The initial dose will be 1.2g/d. This will be increased gradually by 0.6 per 2 weeks to a possible maximum daily dose of 3.6 g/d. Patients will have to remain on a dose for 2 weeks to provide the opportunity to assess clinical response at any one dose. The total duration of the intervention will be 10 weeks."
946359|NCT00962598|E1|Reported Event|Corn Oil|"The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment.~Corn oil: The dosage will correspond to the titration schedule of the Omega-3 Fatty Acid experimental treatment. Placebo (corn oil) and omega-3FA capsules will be identical in color and smell."
946360|NCT00962585|B5|Baseline|Total|Total of all reporting groups
946361|NCT00962585|B4|Baseline|Placebo|Placebo treatment arm
946362|NCT00962585|B3|Baseline|S-equol 150 mg BID|300 mg total daily dose of S-equol
946363|NCT00962585|B2|Baseline|S-equol 50 mg BID|100 mg total daily dose of S-equol
946368|NCT00962585|P1|Participant Flow|S-equol 10 mg BID|20 mg total daily dose of S-equol
946369|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
946370|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
946371|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946372|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946373|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946374|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946375|NCT00962585|O2|Outcome|Placebo|Placebo treatment arm
946376|NCT00962585|O1|Outcome|S-equol Groups Combined|The S-equol groups (S-equol 20 mg total daily dose, 100 mg total daily dose, and 300 mg total daily dose) were combined and regarded as a single treatment group.
946377|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946378|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946379|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946380|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946381|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946382|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946383|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946384|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946385|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946386|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946387|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946388|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946389|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946390|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946391|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946392|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946393|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946394|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946395|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946396|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946397|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946398|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946399|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946400|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946401|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946402|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946403|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946404|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946405|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946406|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946407|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946408|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946409|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946410|NCT00962585|O3|Outcome|S-equol 150 mg BID|300 mg total daily dose of S-equol
946411|NCT00962585|O2|Outcome|S-equol 50 mg BID|100 mg total daily dose of S-equol
946412|NCT00962585|O1|Outcome|S-equol 10 mg BID|20 mg total daily dose of S-equol
946413|NCT00962585|O4|Outcome|Placebo|Placebo treatment arm
946426|NCT00962390|B4|Baseline|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946427|NCT00962390|B3|Baseline|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946428|NCT00962390|B2|Baseline|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946429|NCT00962390|B1|Baseline|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946430|NCT00962390|P4|Participant Flow|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946431|NCT00962390|P3|Participant Flow|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946432|NCT00962390|P2|Participant Flow|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946433|NCT00962390|P1|Participant Flow|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946434|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946435|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946436|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946437|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946438|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946439|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946755|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
946440|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946441|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946442|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946443|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946444|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946445|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946446|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946447|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946448|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946449|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946450|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946451|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946452|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946453|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946454|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946455|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946456|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946457|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946458|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946459|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946460|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946461|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946462|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946463|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946464|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946465|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
951330|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
946466|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946467|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946468|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946469|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946470|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946471|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946472|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946473|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946474|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946475|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946476|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946477|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946478|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946479|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946480|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946481|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946482|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946483|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946484|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946485|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946486|NCT00962390|O4|Outcome|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks."
946487|NCT00962390|O3|Outcome|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks."
946488|NCT00962390|O2|Outcome|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks."
946489|NCT00962390|O1|Outcome|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks."
946490|NCT00962390|E4|Reported Event|Placebo BID|"Placebo Comparator: Placebo~Participants received S-equol placebo capsule matching S-equol orally twice daily for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
946491|NCT00962390|E3|Reported Event|S-equol 150 mg BID|"Experimental: S-equol~Participants received S-equol 150 mg capsule orally twice daily (300 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
946492|NCT00962390|E2|Reported Event|S-equol 50 mg BID|"Experimental: S-equol~Participants received S-equol 50 mg capsule orally twice daily (100 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
946493|NCT00962390|E1|Reported Event|S-equol 10 mg BID|"Experimental: S-equol~Participants received S-equol 10 mg capsule orally twice daily (20 mg total daily dose) for 4 weeks.~At-risk Participants were subjects who received at least one dose of S-at any time during the study."
946494|NCT00962208|B3|Baseline|Total|Total of all reporting groups
946495|NCT00962208|B2|Baseline|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
946496|NCT00962208|B1|Baseline|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
946497|NCT00962208|P2|Participant Flow|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
946498|NCT00962208|P1|Participant Flow|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
946499|NCT00962208|O2|Outcome|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
946500|NCT00962208|O1|Outcome|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
946551|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
946552|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
946501|NCT00962208|E2|Reported Event|Single-vision Spectacle Lenses|Control group: children were asked to wear single-vision spectacles (CR-39 material with refractive index 1.56) in the daytime to correct the refractive error during the study period.
946502|NCT00962208|E1|Reported Event|Orthokeratology Lenses|Study group: children were asked to wear orthokeratology lenses every night (Menicon Z Night Lens: Menicon Z material, DK 163 ISO; central lens thickness: 0.24 mm) to correct the refractive error during the study period.
946503|NCT00962104|B3|Baseline|Total|Total of all reporting groups
946504|NCT00962104|B2|Baseline|Placebo|Taken by mouth, once daily for 10 weeks.
946505|NCT00962104|B1|Baseline|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946506|NCT00962104|P2|Participant Flow|Placebo|Taken by mouth, once daily for 10 weeks.
946507|NCT00962104|P1|Participant Flow|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946508|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946509|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946510|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946511|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946512|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946513|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946514|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
951460|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
946515|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946516|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946517|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946518|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946519|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946520|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946521|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946522|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946523|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946524|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946525|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946526|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946527|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946528|NCT00962104|O2|Outcome|Placebo|Taken by mouth, once daily for 10 weeks.
946529|NCT00962104|O1|Outcome|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946530|NCT00962104|E2|Reported Event|Placebo|Taken by mouth, once daily for 10 weeks.
946531|NCT00962104|E1|Reported Event|Atomoxetine|Treatment was started at 40 milligrams (mg) taken by mouth, once daily. The treatment period was 10 weeks, during which the dosage was up-titrated to a maximum of 120 mg by mouth, once daily.
946532|NCT00962065|B4|Baseline|Total|Total of all reporting groups
946533|NCT00962065|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake for 28 days
946534|NCT00962065|B2|Baseline|High Dose|A high dose of LX4211; daily oral intake for 28 days
946535|NCT00962065|B1|Baseline|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946536|NCT00962065|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 28 days
946537|NCT00962065|P2|Participant Flow|High Dose|A high dose of LX4211; daily oral intake for 28 days
946538|NCT00962065|P1|Participant Flow|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946539|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
946540|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
946541|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946542|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
946543|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
946544|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946545|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
946546|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
946547|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946548|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
951331|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
946553|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946554|NCT00962065|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake for 28 days
946555|NCT00962065|O2|Outcome|High Dose|A high dose of LX4211; daily oral intake for 28 days
946556|NCT00962065|O1|Outcome|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946557|NCT00962065|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 28 days
946558|NCT00962065|E2|Reported Event|High Dose|A high dose of LX4211; daily oral intake for 28 days
946559|NCT00962065|E1|Reported Event|Low Dose|A low dose of LX4211; daily oral intake for 28 days
946560|NCT00962013|B1|Baseline|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946561|NCT00962013|P1|Participant Flow|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946562|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946563|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946564|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946565|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946566|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946567|NCT00962013|O1|Outcome|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946568|NCT00962013|E1|Reported Event|Restoration® Modular|All subjects were enrolled into a single arm and received the Restoration® Modular Revision Hip System to replace the femoral portion of a failed previous implant.
946569|NCT00962000|B1|Baseline|All Study Participants|All subjects who participated in the study.
946570|NCT00962000|P2|Participant Flow|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
946571|NCT00962000|P1|Participant Flow|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
946572|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
946573|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
946574|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
946575|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
946576|NCT00962000|O2|Outcome|800 mL/Min|Dialysate flow rate of 800 mL/min
946577|NCT00962000|O1|Outcome|600 mL/Min|Dialysate flow rate of 600 mL/min
946578|NCT00962000|E2|Reported Event|800 mL/Min First|Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min.
946579|NCT00962000|E1|Reported Event|600 mL/Min First|Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.
946580|NCT00961896|B4|Baseline|Total|Total of all reporting groups
946581|NCT00961896|B3|Baseline|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
946582|NCT00961896|B2|Baseline|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
946583|NCT00961896|B1|Baseline|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
946584|NCT00961896|P3|Participant Flow|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
946585|NCT00961896|P2|Participant Flow|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
946586|NCT00961896|P1|Participant Flow|All Part I Participants|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
946587|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
946588|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
946589|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
946590|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
946591|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
946592|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
946593|NCT00961896|O2|Outcome|LDE225 0.75% [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
946594|NCT00961896|O1|Outcome|LDE225 0.25% [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
946595|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
946596|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
946597|NCT00961896|O4|Outcome|LDE225 0.75% [Part II]|"Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.~LDE225 0.75%"
946598|NCT00961896|O3|Outcome|LDE225 0.25% [Part II]|"Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.~LDE225 0.25%"
946599|NCT00961896|O2|Outcome|Vehicle Cream (Applied in Parallel With LDE225 [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~Vehicle: Placebo cream"
946600|NCT00961896|O1|Outcome|LDE225 (Applied in Parallel With Vehicle) [Part I]|"Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.~LDE225 0.75%"
946601|NCT00961896|E3|Reported Event|0.75% LDE225 [Part II]|Participants were exposed to topically applied 0.75% LDE225 cream twice daily where some basal cell carcinomas (BCCs) were treated for 6 weeks and some BCCs were treated for 9 weeks.
946602|NCT00961896|E2|Reported Event|0.25% LDE225 [Part II]|Participants were exposed to topically applied 0.25% LDE225 cream twice daily for 6 weeks.
946603|NCT00961896|E1|Reported Event|All Part I Participants|Participants were exposed to both topically applied 0.75% LDE225 cream and LDE225 vehicle cream twice daily for 28 days where each treatment was randomized to two different test areas on each participant.
946604|NCT00961805|B3|Baseline|Total|Total of all reporting groups
946605|NCT00961805|B2|Baseline|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home
946606|NCT00961805|B1|Baseline|Group Control|The waiting list
946607|NCT00961805|P2|Participant Flow|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946608|NCT00961805|P1|Participant Flow|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946609|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946610|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946611|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946612|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946664|NCT00961649|E2|Reported Event|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946665|NCT00961649|E1|Reported Event|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946613|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946614|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946615|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946616|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946676|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
946677|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
946678|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
946617|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946618|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946619|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946620|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946621|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946622|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946623|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946624|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946625|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946626|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946627|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946628|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946666|NCT00961636|B4|Baseline|Total|Total of all reporting groups
946629|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946630|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946631|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946632|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946633|NCT00961805|O2|Outcome|Dance Group|The participants in the dance group took one-hour belly dance classes twice a week for 16 weeks. Each class had a maximum of eight students. The classes were administered by a physiotherapist with eight years of experience in belly dance. Classes began with a warm-up exercise, followed by the predetermined movements for the day, choreography and a cool-down exercise. The participants received a compact disc with music and an exercise book with the history and movements proposed for the program. Beginning in the fourth week, a set sequence of movements in the form of choreography was established for memorization and training at home.
946634|NCT00961805|O1|Outcome|Control Group|The control group did not receive any intervention. They attended all assessments and remained on the waiting lis (after the end of the study was offered to this group the same treatment in the intervention group).
946635|NCT00961662|B4|Baseline|Total|Total of all reporting groups
946636|NCT00961662|B3|Baseline|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946637|NCT00961662|B2|Baseline|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
946638|NCT00961662|B1|Baseline|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946639|NCT00961662|P3|Participant Flow|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946640|NCT00961662|P2|Participant Flow|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
946641|NCT00961662|P1|Participant Flow|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946642|NCT00961662|O3|Outcome|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946643|NCT00961662|O2|Outcome|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
946644|NCT00961662|O1|Outcome|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946645|NCT00961662|E3|Reported Event|7.5 High Dose|high dose. 7.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946646|NCT00961662|E2|Reported Event|5.0 Mid Dose|5.0 dose, 5.0 g TID premixed with drinking water into a solution of 4 oz per dose.
946647|NCT00961662|E1|Reported Event|2.5 Active|Low dose, 2.5 g TID premixed with drinking water into a solution of 4 oz per dose.
946648|NCT00961649|B5|Baseline|Total|Total of all reporting groups
946649|NCT00961649|B4|Baseline|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946650|NCT00961649|B3|Baseline|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946651|NCT00961649|B2|Baseline|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946652|NCT00961649|B1|Baseline|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946653|NCT00961649|P4|Participant Flow|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946654|NCT00961649|P3|Participant Flow|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946655|NCT00961649|P2|Participant Flow|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946656|NCT00961649|P1|Participant Flow|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946657|NCT00961649|O2|Outcome|Brinz+Brim|Brinzolamide ophthalmic suspension, 1% and brimonidine tartrate ophthalmic solution, 0.2%: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946658|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946659|NCT00961649|O3|Outcome|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946660|NCT00961649|O2|Outcome|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946661|NCT00961649|O1|Outcome|Brinz/Brim|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946662|NCT00961649|E4|Reported Event|Brim|Brimonidine tartrate ophthalmic solution, 0.2% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946663|NCT00961649|E3|Reported Event|Brinz|Brinzolamide ophthalmic suspension, 1% and Vehicle: 1 drop each instilled in both eyes 3 times a day for 6 weeks
946667|NCT00961636|B3|Baseline|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
946668|NCT00961636|B2|Baseline|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
946669|NCT00961636|B1|Baseline|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
946670|NCT00961636|P3|Participant Flow|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
946671|NCT00961636|P2|Participant Flow|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
946672|NCT00961636|P1|Participant Flow|ERN/LRPT|One 1g/20 mg tablet Extended -release niacin (+) laropiprant (ERN/LRPT) once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
946673|NCT00961636|O3|Outcome|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
946674|NCT00961636|O2|Outcome|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
946675|NCT00961636|O1|Outcome|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
946679|NCT00961636|E3|Reported Event|Placebo|One tablet placebo to ERN/LRPT once daily for 4 weeks, then two tablets placebo to ERN/LRPT daily for 28 weeks.
946680|NCT00961636|E2|Reported Event|ERN/LRPT Then ERN|One 1g/20mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 16 weeks then Two 1g tablets ERN (2g total) once daily for 12 weeks.
946681|NCT00961636|E1|Reported Event|ERN/LRPT|One 1g/20 mg tablet ERN/LRPT once daily for 4 weeks, then two 1g/20 mg tablets daily (2g/40 mg total) for 28 weeks
946682|NCT00961571|B1|Baseline|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
946683|NCT00961571|P1|Participant Flow|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
946684|NCT00961571|O1|Outcome|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
946685|NCT00961571|E1|Reported Event|Sunitinib and Cepecitabine|"Administration of sunitinib and capecitabine~sunitinib and capecitabine: Sunitinib 37.5 mg po once daily Capecitabine 1000 mg po twice daily"
946686|NCT00961532|B1|Baseline|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
946687|NCT00961532|P1|Participant Flow|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
946688|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
946689|NCT00961532|O1|Outcome|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
946690|NCT00961532|E1|Reported Event|DDAVP|"DDAVP 0.4 mcg/kg intravenously in 250 mL NS over 30 minutes~DDAVP injection (desmopressin acetate): 0.4 mcg/kg in 250 mL NS intravenously once over 30 minutes"
946691|NCT00961441|B3|Baseline|Total|Total of all reporting groups
946692|NCT00961441|B2|Baseline|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946693|NCT00961441|B1|Baseline|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946694|NCT00961441|P2|Participant Flow|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946695|NCT00961441|P1|Participant Flow|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946696|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946697|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946698|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946699|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946700|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946701|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946702|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946703|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946704|NCT00961441|O2|Outcome|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946705|NCT00961441|O1|Outcome|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946706|NCT00961441|E2|Reported Event|Keppra XR in Adults (18-55 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946707|NCT00961441|E1|Reported Event|Keppra XR in Children (12-16 Years Old)|"Drug: Keppra XR~Keppra XR 500 mg tablets and Keppra XR 750 mg tablets~Dosage: Keppra XR 1000-3000 mg/day taken once daily~Duration: 4-7 days"
946708|NCT00961415|B3|Baseline|Total|Total of all reporting groups
946709|NCT00961415|B2|Baseline|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946710|NCT00961415|B1|Baseline|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946753|NCT00961350|P2|Participant Flow|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947274|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
946711|NCT00961415|P3|Participant Flow|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946712|NCT00961415|P2|Participant Flow|Bevacizumab Maintenance Treatment (Trt) Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946713|NCT00961415|P1|Participant Flow|Induction Treatment Phase|Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m^2 + pemetrexed 500 mg/m^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy.
946714|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 mcg daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946715|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy
946716|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm...
946717|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
946718|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
946719|NCT00961415|O3|Outcome|No Maintenance Trt|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
946720|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis.
946721|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis.
946722|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
947262|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
946723|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946724|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946725|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946726|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946754|NCT00961350|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
946727|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946728|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946729|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946730|NCT00961415|O2|Outcome|Bevacizumab +Pemetrexed Maintenance Trt Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram [mcg] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days −1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946731|NCT00961415|O1|Outcome|Bevacizumab Maintenance Trt Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
946732|NCT00961415|E3|Reported Event|Maintenance Treatment Arm B|Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
946733|NCT00961415|E2|Reported Event|Maintenance Treatment Arm A|Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis
946734|NCT00961415|E1|Reported Event|No Maintenance Treatment|A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm..
946735|NCT00961402|B3|Baseline|Total|Total of all reporting groups
946736|NCT00961402|B2|Baseline|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
946737|NCT00961402|B1|Baseline|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
946738|NCT00961402|P2|Participant Flow|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
946739|NCT00961402|P1|Participant Flow|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
946740|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
946741|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
946742|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
946743|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
946844|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
946744|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
946745|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
946746|NCT00961402|O2|Outcome|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
946747|NCT00961402|O1|Outcome|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
946748|NCT00961402|E2|Reported Event|Exercise|"Intervention will include motivational telephone-based intervention to increase exercise to 5 days per week for 30 minutes or more each session.~Exercise: 6-month exercise intervention vs. wellness control"
946749|NCT00961402|E1|Reported Event|Wellness Control|"Participants will receive health and wellness information and no exercise information.~Exercise: 6-month exercise intervention vs. wellness control"
946750|NCT00961350|B3|Baseline|Total|Total of all reporting groups
946751|NCT00961350|B2|Baseline|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
946752|NCT00961350|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
951461|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
946756|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
946757|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
946758|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
946759|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
946760|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
946761|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
946762|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
946763|NCT00961350|O2|Outcome|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
946764|NCT00961350|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
946765|NCT00961350|E2|Reported Event|EC Aspirin|EC Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
946766|NCT00961350|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
946767|NCT00961311|B1|Baseline|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
946768|NCT00961311|P1|Participant Flow|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
946769|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
946770|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
946771|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
946772|NCT00961311|O1|Outcome|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
946773|NCT00961311|E1|Reported Event|Balloon Angioplasty|All patients with systematic ischemic heart disease with stenotic lesions that are amenable to percutaneous coronary treatment. Study participants were treated with the Sprinter Legend 1.25mm angioplasty balloon.
946774|NCT00961298|B1|Baseline|Treatment Arm|every subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
946775|NCT00961298|P1|Participant Flow|Treatment Arm|Every study eligible subject entered a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
946776|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
946777|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
946778|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
946779|NCT00961298|O1|Outcome|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
946780|NCT00961298|E1|Reported Event|Treatment Arm|every study eligible subject had a two week placebo run in followed by 12 weeks treatment intervention with Duloxetine.
946845|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
947263|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
946781|NCT00961259|B1|Baseline|Fenofibric Acid - Treatments A, B and C|All subjects received each of the three study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8 and 15 each subject received either one 35 mg fenofibric acid tablet (treatment A), three 35 mg fenofibric acid tablets (105 mg total dose, treatment B) or one 105 mg fenofibric acid tablet (treatment C).
946782|NCT00961259|P3|Participant Flow|Treatment Sequence CAB|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B).
946783|NCT00961259|P2|Participant Flow|Treatment Sequence BCA|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (105 mg total dose, treatment B). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A).
946784|NCT00961259|P1|Participant Flow|Treatment Sequence ABC|On the morning of Day 1 after an overnight fast of at least 10 hours, each subject received one 35 mg fenofibric acid tablet (treatment A). After a 7 day washout period, on the morning of Day 8 after an overnight fast of at least 10 hours, each subject received three 35 mg fenofibric acid tablets (treatment B). After a 7 day washout period, on the morning of Day 15 after an overnight fast of at least 10 hours, each subject received one 105 mg fenofibric acid tablet (treatment C).
946785|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
946786|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946787|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946788|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946789|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
946790|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946791|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946792|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946793|NCT00961259|O4|Outcome|Fenofibric Acid 105 mg (1 x 105 mg Tablet) - Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
946794|NCT00961259|O3|Outcome|Fenofibric Acid 105 mg (3 x 35 mg Tablet) - Treatment B|Each subject received three tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946795|NCT00961259|O2|Outcome|Fenofibric Acid 35 mg (35 mg Dose-adjusted to 105 mg)|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946796|NCT00961259|O1|Outcome|Fenofibric Acid 35 mg (1 x 35 mg Tablet) - Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946797|NCT00961259|E3|Reported Event|Fenofibric Acid 105 mg (1 x 105 mg Tablet), Treatment C|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
946798|NCT00961259|E2|Reported Event|Fenofibric Acid 105 mg (3 x 35 mg Tablet), Treatment B|Each subject received three (3) tablets of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946799|NCT00961259|E1|Reported Event|Fenofibric Acid 35 mg (1 x 35 mg Tablet), Treatment A|Each subject received one tablet of 35 mg fenofibric acid after an overnight fast of at least 10 hours.
946800|NCT00961233|B3|Baseline|Total|Total of all reporting groups
946801|NCT00961233|B2|Baseline|Viscous/Swallowed Budesonide|
946802|NCT00961233|B1|Baseline|Inhaled/Swallowed Budesonide|
946803|NCT00961233|P2|Participant Flow|Viscous/Swallowed Budesonide|viscous/swallowed budesonide - budesonide slurry (created with 5g sucralose) 1 mg twice daily that is swallowed
946804|NCT00961233|P1|Participant Flow|Inhaled/Swallowed Budesonide|inhaled/swallowed budesonide - nebulized budesonide 1mg twice daily that is swallowed.
946805|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|viscous slurry of budesonide and sucralose 1 mg twice daily
946806|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|nebulized then swallowed budesonide 1mg twice daily
946807|NCT00961233|O2|Outcome|Viscous/Swallowed Budesonide|
946808|NCT00961233|O1|Outcome|Inhaled/Swallowed Budesonide|
946809|NCT00961233|E2|Reported Event|Viscous/Swallowed Budesonide|
946810|NCT00961233|E1|Reported Event|Inhaled/Swallowed Budesonide|
946811|NCT00961220|B1|Baseline|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946842|NCT00961116|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, after an overnight fast.
951332|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
946812|NCT00961220|P1|Participant Flow|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946813|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946814|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946815|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946816|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946817|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946818|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946819|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946820|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946821|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946843|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
947402|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
946822|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946823|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946824|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~carmustine: Applied topically. BCNU will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946825|NCT00961220|O1|Outcome|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV~carmustine: Applied topically~laboratory biomarker analysis: Correlative studies"
946826|NCT00961220|E1|Reported Event|Treatment (O6-benzylguanine, Carmustine)|"Patients receive O6-benzylguanine IV over 1 hour and apply topical carmustine to the total skin surface (excluding the lips, eyelids, and ulcerated lesions) 1 hour after completing O6-benzylguanine infusion on days 1-2. Treatment repeats every 2 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.~O6-benzylguanine: Given IV. 120 mg/m2 over 1 hour~Carmustine (BCNU) will begin at a starting dose of 20 mg on Day 1. Beyond this first dose level, for each of the subsequent four patients enrolled, the BCNU dose will be escalated up to a limit of 40 mg total (given on day 1 only).~laboratory biomarker analysis: Correlative studies"
946827|NCT00961181|B1|Baseline|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946828|NCT00961181|P1|Participant Flow|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclusion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946829|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946830|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946831|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946832|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946833|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946834|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946835|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946836|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946837|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946838|NCT00961181|O1|Outcome|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946839|NCT00961181|E1|Reported Event|Paclitaxel Releasing Balloon|Patients meeting all inclusion and none of the exclsuion criteria were enrolled and treated with the study device, the Pantera Lux paclitaxel releasing balloon, as per protocol.
946840|NCT00961116|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg following an overnight fast.
946841|NCT00961116|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference, fenofibrate 145 mg after an overnight fast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, after an overnight fast.
947403|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
946846|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
946847|NCT00961116|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg after an overnight fast of at least 10 hours.
946848|NCT00961116|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg after an overnight fast of at least 10 hours.
946849|NCT00961116|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg after an overnight fast of at least 10 hours.
946850|NCT00961116|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg after an overnight fast of at least 10 hours.
946851|NCT00961051|B3|Baseline|Total|Total of all reporting groups
946852|NCT00961051|B2|Baseline|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
946853|NCT00961051|B1|Baseline|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
946854|NCT00961051|P2|Participant Flow|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
946855|NCT00961051|P1|Participant Flow|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
946856|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
946857|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
946858|NCT00961051|O2|Outcome|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
946859|NCT00961051|O1|Outcome|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
946860|NCT00961051|E2|Reported Event|Predicate MPS|Opti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
946861|NCT00961051|E1|Reported Event|Investigational MPS|Investigational multipurpose disinfecting solution (study MPS)
946862|NCT00960999|B3|Baseline|Total|Total of all reporting groups
946863|NCT00960999|B2|Baseline|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
946864|NCT00960999|B1|Baseline|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
946865|NCT00960999|P2|Participant Flow|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
946866|NCT00960999|P1|Participant Flow|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
946867|NCT00960999|O2|Outcome|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
946868|NCT00960999|O1|Outcome|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
946869|NCT00960999|E2|Reported Event|Multiple-fraction SBRT (48 Gy)|Multiple-fraction stereotactic body radiation therapy (SBRT) given in four daily 12 Gy fractions for a total dose of 48 Gy
946870|NCT00960999|E1|Reported Event|Single-fraction SBRT (34 Gy)|Single-fraction stereotactic body radiation therapy (SBRT) of 34 Gy
946871|NCT00960986|B5|Baseline|Total|Total of all reporting groups
946872|NCT00960986|B4|Baseline|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946873|NCT00960986|B3|Baseline|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946874|NCT00960986|B2|Baseline|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946875|NCT00960986|B1|Baseline|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946876|NCT00960986|P4|Participant Flow|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946877|NCT00960986|P3|Participant Flow|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946878|NCT00960986|P2|Participant Flow|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946879|NCT00960986|P1|Participant Flow|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946880|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946881|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946882|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946883|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946884|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946885|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946886|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946887|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946888|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946889|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946890|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946891|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946892|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946893|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946894|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946895|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946896|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946897|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946898|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946899|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946900|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946901|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946902|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946903|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946904|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946905|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946906|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946907|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946908|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946909|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946910|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946911|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946912|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946913|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946914|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946915|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946916|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946917|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946918|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946919|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946920|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946921|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946922|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946923|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946924|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946925|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946926|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946927|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946928|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946929|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946930|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946931|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946932|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946933|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946934|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946935|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946936|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946937|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946938|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946939|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946940|NCT00960986|O4|Outcome|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946941|NCT00960986|O3|Outcome|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946942|NCT00960986|O2|Outcome|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
951333|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
946943|NCT00960986|O1|Outcome|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946944|NCT00960986|E4|Reported Event|Duloxetine 60 mg Without Food|Duloxetine 60 mg capsule po QD without food for 8 weeks
946945|NCT00960986|E3|Reported Event|Duloxetine 30 mg Without Food|Duloxetine 30 mg capsule po QD without food for 1 week, then 60 mg without food for 7 weeks
946946|NCT00960986|E2|Reported Event|Duloxetine 60 mg With Food|Duloxetine 60 milligram (mg) capsule oral (po), once daily (QD) with food for 8 weeks
946947|NCT00960986|E1|Reported Event|Duloxetine 30 mg With Food|Duloxetine 30 mg capsule po QD with food for 1 week, then 60 mg with food for 7 weeks
946948|NCT00960934|B7|Baseline|Total|Total of all reporting groups
946949|NCT00960934|B6|Baseline|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946950|NCT00960934|B5|Baseline|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946951|NCT00960934|B4|Baseline|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946952|NCT00960934|B3|Baseline|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946953|NCT00960934|B2|Baseline|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946954|NCT00960934|B1|Baseline|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
946955|NCT00960934|P6|Participant Flow|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946956|NCT00960934|P5|Participant Flow|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946957|NCT00960934|P4|Participant Flow|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946958|NCT00960934|P3|Participant Flow|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946959|NCT00960934|P2|Participant Flow|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946960|NCT00960934|P1|Participant Flow|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
946961|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946962|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946963|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946964|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946965|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946966|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
946967|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946968|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946969|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946970|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946971|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946972|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
946973|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946974|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946975|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946976|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946977|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946978|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
946979|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946980|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946981|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946982|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946983|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946984|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
946985|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946986|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946987|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946988|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946989|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946990|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947367|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
946991|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946992|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946993|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
946994|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
946995|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
946996|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
946997|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
946998|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
946999|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947000|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947001|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947002|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947003|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947004|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947005|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947006|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947007|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947008|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947009|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947010|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947011|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947012|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947013|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947014|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947015|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947016|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947127|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
947017|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947018|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947019|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947020|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947021|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947022|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947023|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947024|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947025|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947026|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947027|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947028|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947029|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947030|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947031|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947032|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947033|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947034|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947035|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947036|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947037|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947038|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947039|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947040|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947041|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947042|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947043|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947044|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947045|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947046|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947047|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947048|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947049|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947050|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947051|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947052|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947544|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
947053|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947054|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947055|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947056|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947057|NCT00960934|O6|Outcome|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947058|NCT00960934|O5|Outcome|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947059|NCT00960934|O4|Outcome|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947060|NCT00960934|O3|Outcome|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947061|NCT00960934|O2|Outcome|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947062|NCT00960934|O1|Outcome|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947063|NCT00960934|E6|Reported Event|Placebo|Following a 2-week open-label placebo run-in, participants received a daily oral dose of placebo dose-matched to MK-5442 for a duration of at least 6 months.
947064|NCT00960934|E5|Reported Event|MK-5442 15 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 15 mg of MK-5442 for a duration of at least 6 months.
947065|NCT00960934|E4|Reported Event|MK-5442 10 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 10 mg of MK-5442 for a duration of at least 6 months.
947066|NCT00960934|E3|Reported Event|MK-5442 7.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 7.5 mg of MK-5442 for a duration of at least 6 months.
947067|NCT00960934|E2|Reported Event|MK-5442 5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 5 mg of MK-5442 for a duration of at least 6 months.
947068|NCT00960934|E1|Reported Event|MK-5442 2.5 mg|Following a 2-week open-label placebo run-in, participants received a daily oral dose of 2.5 mg of MK-5442 for a duration of at least 6 months.
947069|NCT00960869|B3|Baseline|Total|Total of all reporting groups
947070|NCT00960869|B2|Baseline|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947071|NCT00960869|B1|Baseline|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947072|NCT00960869|P2|Participant Flow|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947073|NCT00960869|P1|Participant Flow|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947074|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947075|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947076|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947077|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947078|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947079|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947080|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947081|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947082|NCT00960869|O2|Outcome|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947083|NCT00960869|O1|Outcome|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947084|NCT00960869|E2|Reported Event|EC-Aspirin 325 mg|EC-Aspirin 325 mg enteric coated tablet (PA32540 minus omeprazole) dosed once daily (QD)
947085|NCT00960869|E1|Reported Event|PA32540|PA32540 tablets contain 325 mg enteric coated (EC) aspirin and 40 mg immediate-release omeprazole dosed once daily (QD)
947086|NCT00960856|B1|Baseline|Low-Fat Meal, Standard Meal, High Fat/High Calorie Meal,Fasted|All subjects received each of the four study regimens in a randomly assigned sequence of dosing periods. On the mornings of Days 1, 8, 15 and 22 each subject received one tablet of fenofibric acid 105 mg administered after one of the following meal conditions: 1) low-fat meal, 2) standard meal, 3) high-fat/high-calorie meal 4) overnight fast of at least 10 hours.
947087|NCT00960856|P4|Participant Flow|Sequence DABC|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
947088|NCT00960856|P3|Participant Flow|Sequence CDAB|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
947089|NCT00960856|P2|Participant Flow|Sequence BCDA|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state
947128|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
947090|NCT00960856|P1|Participant Flow|Sequence ABCD|Participants received one 105 mg fenofibric acid tablet following each of the following four meal conditions, in this order: A= Low-fat meal, B= standard meal, C= high-fat/high-calorie meal, D= fasted state.
947091|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
947092|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
947093|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
947094|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
947095|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
947096|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
947097|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
947098|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
947099|NCT00960856|O4|Outcome|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid after an overnight fast of at least 10 hours.
947368|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947100|NCT00960856|O3|Outcome|High-Fat, High-Calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
947101|NCT00960856|O2|Outcome|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
947102|NCT00960856|O1|Outcome|Low-fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
947103|NCT00960856|E4|Reported Event|Fasted - Treatment D|Each subject received one tablet of 105 mg fenofibric acid following an overnight fast of at least 10 hours.
947104|NCT00960856|E3|Reported Event|High-fat, High-calorie Meal - Treatment C|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a high-fat, high-calorie breakfast.
947105|NCT00960856|E2|Reported Event|Standard Meal - Treatment B|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a standard breakfast.
947106|NCT00960856|E1|Reported Event|Low-Fat Meal - Treatment A|Each subject received one tablet of 105 mg fenofibric acid 30 minutes after the initiation of a low-fat breakfast.
947107|NCT00960843|B3|Baseline|Total|Total of all reporting groups
947108|NCT00960843|B2|Baseline|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
947109|NCT00960843|B1|Baseline|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
947110|NCT00960843|P2|Participant Flow|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
947111|NCT00960843|P1|Participant Flow|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
947112|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
947113|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
947114|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
947115|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
947116|NCT00960843|O2|Outcome|Intraband Pressure Arm|Pressure adjustments based on protocol instructions regarding intraband pressure measurements
947117|NCT00960843|O1|Outcome|Conventional Arm|Pressure adjustments based on recommendations in the approved label for the Swedish Adjustable Gastric band
947118|NCT00960843|E2|Reported Event|Intraband Pressure Arm|Subjects whose band adjustments will be guided by intraband pressure readings.
947119|NCT00960843|E1|Reported Event|Conventional Adjustment Group|Subject whose band adjustments will be made via conventional standard of care (e.g., volume, hunger).
947120|NCT00960687|B1|Baseline|Fenofibric Acid 105 mg Tablets and Fenofibrate 145 mg Tablets|All subjects received each of the two study regimens in a randomly assigned sequence of dosing periods. On the mornings of Day 1 and Day 8, each subject received one tablet of either fenofibric acid 105 mg or fenofibrate 145 mg, 30 minutes after the initiation of a standard meal.
947121|NCT00960687|P2|Participant Flow|Fenofibrate 145 mg Tablets Then Fenofibric Acid 105 mg Tablets|On the morning of Day 1 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast.
947122|NCT00960687|P1|Participant Flow|Fenofibric Acid 105 mg Tablets Then Fenofibrate 145 mg Tablets|On the morning of Day 1 subjects received one tablet of the test formulation, fenofibric acid 105 mg, 30 minutes after the initiation of a standard breakfast, followed by a 7 day washout period. On the morning of Day 8 subjects received one tablet of the reference formulation, fenofibrate 145 mg, 30 minutes after the initiation of a standard breakfast.
947123|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
947124|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
947125|NCT00960687|O2|Outcome|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145mg 30 minutes after the initiation of a standard breakfast.
947126|NCT00960687|O1|Outcome|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105mg 30 minutes after the initiation of a standard breakfast.
951334|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
947129|NCT00960687|E2|Reported Event|Fenofibrate 145 mg Tablets|Each subject received one tablet of fenofibrate 145 mg 30 minutes after the initiation of a standard breakfast.
947130|NCT00960687|E1|Reported Event|Fenofibric Acid 105 mg Tablets|Each subject received one tablet of fenofibric acid 105 mg 30 minutes after the initiation of a standard breakfast.
947131|NCT00960661|B3|Baseline|Total|Total of all reporting groups
947132|NCT00960661|B2|Baseline|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947133|NCT00960661|B1|Baseline|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947134|NCT00960661|P3|Participant Flow|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947135|NCT00960661|P2|Participant Flow|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947136|NCT00960661|P1|Participant Flow|Enrolled|Patients who enrolled in the basal insulin optimization (BIO) phase
947137|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947138|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947139|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947140|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947141|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947142|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947143|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947144|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947145|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947146|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947147|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947148|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947149|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947150|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947151|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947152|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947153|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947154|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947155|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947156|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947157|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947158|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947159|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947160|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947161|NCT00960661|O2|Outcome|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947162|NCT00960661|O1|Outcome|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947163|NCT00960661|E2|Reported Event|Insulin Lispro (BBT)|Basal Insulin/Glargine, Bolus Insulin Lispro and Metformin Therapy (BBT)
947164|NCT00960661|E1|Reported Event|Exenatide (BET)|Basal Insulin/Glargine, Exenatide and Metformin Therapy (BET)
947165|NCT00960622|B3|Baseline|Total|Total of all reporting groups
947166|NCT00960622|B2|Baseline|Combivir, Trizivir.|continue on Combivir, trizivir.
947167|NCT00960622|B1|Baseline|Truvada|switch from Combivir to Truvada
947168|NCT00960622|P2|Participant Flow|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|The study subjects will be randomly assigned to continue on Combivir or trizivir.This will serve as comparator group.
947169|NCT00960622|P1|Participant Flow|Truvada 200/300 mg, Daily, by Mouth.|The study subjects will be randomly assigned to switch from Combivir or from trizivir to open-label Truvada.
947170|NCT00960622|O2|Outcome|Combivir 150/300 mg, or Trizivir 300/150/300 mg Daily.|continue on Combivir 150/300 mg, or trizivir 300/150/300 mg daily.
947171|NCT00960622|O1|Outcome|Truvada 200/300 mg, Daily, by Mouth.|switch from Combivir or trizivir to Truvada 200/300 mg, daily, by mouth.
947172|NCT00960622|E2|Reported Event|Combivir, Trizivir.|continue on Combivir, trizivir.
947173|NCT00960622|E1|Reported Event|Truvada|switch from Combivir to Truvada
947174|NCT00960570|B1|Baseline|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
947175|NCT00960570|P1|Participant Flow|Efavirenz Alone,Fenofibric Acid (FFA) Alone, Efavirenz and FFA|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period. On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals. On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg following an overnight fast of at least 10 hours.
947176|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
947177|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
947178|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
947179|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
947180|NCT00960570|O2|Outcome|Efavirenz With Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
947181|NCT00960570|O1|Outcome|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
947182|NCT00960570|E3|Reported Event|Efavirenz and Fenofibric Acid|On the morning of Day 31, subjects received a co-administered single oral dose of efavirenz 600 mg and fenofibric acid 105 mg after an overnight fast.
947183|NCT00960570|E2|Reported Event|Fenofibric Acid Alone|On the mornings of Days 22-30, subjects received a dose of fenofibric acid 105 mg without regard to meals.
947184|NCT00960570|E1|Reported Event|Efavirenz Alone|On the morning of Day 1, subjects received a single dose of efavirenz 600 mg after an overnight fast of at least 10 hours, followed by a 21 day washout period.
947185|NCT00960531|B11|Baseline|Total|Total of all reporting groups
947456|NCT00960206|P2|Participant Flow|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
947186|NCT00960531|B10|Baseline|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947187|NCT00960531|B9|Baseline|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947188|NCT00960531|B8|Baseline|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947189|NCT00960531|B7|Baseline|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947190|NCT00960531|B6|Baseline|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947191|NCT00960531|B5|Baseline|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947192|NCT00960531|B4|Baseline|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947193|NCT00960531|B3|Baseline|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947194|NCT00960531|B2|Baseline|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947195|NCT00960531|B1|Baseline|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947196|NCT00960531|P10|Participant Flow|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947197|NCT00960531|P9|Participant Flow|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947198|NCT00960531|P8|Participant Flow|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947199|NCT00960531|P7|Participant Flow|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947200|NCT00960531|P6|Participant Flow|PBS / ACC 10 µg+QS-21|Participants received Phosphate buffered Saline (PBS) in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947201|NCT00960531|P5|Participant Flow|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947202|NCT00960531|P4|Participant Flow|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947203|NCT00960531|P3|Participant Flow|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947204|NCT00960531|P2|Participant Flow|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947545|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
947205|NCT00960531|P1|Participant Flow|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947206|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947207|NCT00960531|O9|Outcome|QS-21 / ACC 30 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947208|NCT00960531|O8|Outcome|ACC 30 µg / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947209|NCT00960531|O7|Outcome|ACC 30 µg+QS-21 / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947210|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
948869|NCT00957047|P2|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
947211|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947212|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947213|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947214|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947215|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947216|NCT00960531|O6|Outcome|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947217|NCT00960531|O5|Outcome|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947218|NCT00960531|O4|Outcome|Control / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947219|NCT00960531|O3|Outcome|Active / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947220|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947221|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947222|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947223|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947224|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947225|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947226|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947227|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947228|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947229|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947261|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947230|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947231|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947232|NCT00960531|O10|Outcome|PBS / ACC 30 μg+QS-21|Participants received PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947233|NCT00960531|O9|Outcome|QS-21 / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947234|NCT00960531|O8|Outcome|ACC 30 μg / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947235|NCT00960531|O7|Outcome|ACC 30 μg+QS-21 / ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947236|NCT00960531|O6|Outcome|PBS / ACC 10 μg+QS-21|Participants received PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947237|NCT00960531|O5|Outcome|QS-21 / ACC 10 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947238|NCT00960531|O4|Outcome|ACC 10 µg / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947239|NCT00960531|O3|Outcome|ACC 10 µg+QS-21 / ACC 10 µg+QS-21|Participants 10 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947240|NCT00960531|O2|Outcome|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947241|NCT00960531|O1|Outcome|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947242|NCT00960531|E6|Reported Event|Control / ACC 30 μg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947243|NCT00960531|E5|Reported Event|Active / ACC 30 µg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21 or 30 μg of ACC-001 alone in the lead-in study and 30 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947244|NCT00960531|E4|Reported Event|Control / ACC 10µg+QS-21|Participants received 50 μg of QS-21 or PBS in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947245|NCT00960531|E3|Reported Event|Active / ACC 10 µg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21 or 10 μg of ACC-001 alone in the lead-in study and 10 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947246|NCT00960531|E2|Reported Event|QS-21 / ACC 3 µg+QS-21|Participants received 50 μg of QS-21 in the lead-in study and 3 μg of ACC-001 and 50 μg of QS-21 in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947247|NCT00960531|E1|Reported Event|ACC 3 µg+QS-21 / ACC 3 µg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21 in the lead-in study and in the extension study. Test article was given by intramuscular injection into the deltoid muscle at 0, 6, 12, and 18 months.
947248|NCT00960440|B5|Baseline|Total|Total of all reporting groups
947249|NCT00960440|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947250|NCT00960440|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947251|NCT00960440|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947252|NCT00960440|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947253|NCT00960440|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947254|NCT00960440|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947255|NCT00960440|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947256|NCT00960440|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
947257|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947258|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947259|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947260|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947264|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947265|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947266|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947267|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947268|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947269|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947270|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947271|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947272|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947273|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947275|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947276|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947277|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947278|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947279|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947280|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947281|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947282|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947283|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947284|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947285|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947286|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947287|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947288|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947289|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947290|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947291|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947292|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947293|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947294|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947295|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947296|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947297|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947298|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947299|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947300|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947301|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947302|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947303|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947304|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947305|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947306|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947307|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947308|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947309|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
951335|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
947310|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947311|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947312|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947313|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947314|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947315|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947316|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947317|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947318|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947319|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947320|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947321|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947322|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947323|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947324|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947325|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947326|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947327|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947328|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947329|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947330|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947331|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947332|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947333|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947334|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947335|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947336|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947337|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947338|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947339|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947340|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947341|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947342|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947343|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947344|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947345|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947346|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947347|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947348|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947349|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947350|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947351|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947352|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947353|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947354|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947355|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
951336|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
947356|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947357|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947358|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947359|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947360|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947361|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947362|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947363|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947364|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947365|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947366|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947369|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947370|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947371|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947372|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947373|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947374|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947375|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947376|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947377|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947378|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947379|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947380|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947381|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947382|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947383|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947384|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947385|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947386|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947387|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947388|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947389|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947390|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947391|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947392|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947393|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947394|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947395|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947396|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947397|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947398|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947399|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947400|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947401|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
951337|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
947404|NCT00960440|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily orally up to Month 6.
947405|NCT00960440|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet orally twice daily up to Month 6.
947406|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947407|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947408|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947409|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947410|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947411|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947412|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947413|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947414|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947415|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947416|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947417|NCT00960440|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Month 3 followed by CP-690,550 5mg or 10 mg tablet orally twice daily up to Month 6.
947418|NCT00960440|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
947419|NCT00960440|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Month 6.
947420|NCT00960440|E5|Reported Event|CP-690,550 10 mg From Month 3 to 6|CP-690,550 10 mg tablets orally twice daily from Month 3 to Month 6.
947421|NCT00960440|E4|Reported Event|CP-690,550 5 mg From Month 3 to 6|CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
947422|NCT00960440|E3|Reported Event|Placebo Up to Month 3|Placebo matching to CP-690,550 5 mg tablet orally twice daily up to Month 3.
947423|NCT00960440|E2|Reported Event|CP-690,550 10 mg Up to Month 3|CP-690,550 10 mg tablets orally twice daily up to Month 3.
947424|NCT00960440|E1|Reported Event|CP-690,550 5 mg Up to Month 3|CP-690,550 5 mg tablet orally twice daily up to Month 3.
947425|NCT00960375|B3|Baseline|Total|Total of all reporting groups
947426|NCT00960375|B2|Baseline|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
947427|NCT00960375|B1|Baseline|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
947428|NCT00960375|P2|Participant Flow|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
947429|NCT00960375|P1|Participant Flow|BTSCS|BTSCS includes two 60-minute groups/week (24 total). It is delivered in groups of 4-8 participants run by a trained interventionist. It includes: (1) individual motivational enhancement session to help participants think about personal reasons for change; (2) Breath CO monitoring and goal-setting; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about negative health effects of smoking; (5) Relapse prevention; (6) Education about and assistance with nicotine replacement therapy.
947430|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
947431|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
947432|NCT00960375|O2|Outcome|StSST|The StSST program was adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants will do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups will provide education about smoking and support for quitting. Smoking education sessions will involve weekly (24 sessions total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
947457|NCT00960206|P1|Participant Flow|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
948870|NCT00957047|P1|Participant Flow|Placebo|placebo : once daily placebo comparator
947433|NCT00960375|O1|Outcome|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
947434|NCT00960375|E2|Reported Event|StSST|The StSST program is adapted from a 9-session weekly smoking cessation group program developed at the Outpatient Research Program of the Maryland Psychiatric Research Center and designed for people with schizophrenia. In this study, the StSST program meets twice per week for 3 months (24 sessions total). Participants will complete a breath CO test at the start of each education session with no associated feedback of results or financial contingency. To avoid possible discussion of the CO test and results, participants do the CO test individually just outside the group room. There is no payment or contingency for CO testing in this condition. StSST groups provide education about smoking and support for quitting. Smoking education groups involve weekly (24 groups total) smoking cessation educational groups modeled after Addington et al. (1998) and modified using the educational materials of the American Cancer Society (ACS) Fresh Start Program.
947435|NCT00960375|E1|Reported Event|BTSCS|BTSCS lasts 3 months, includes two 60-minute group sessions per week (24 sessions total), and is delivered in small groups of 4-8 participants run by a trained therapist. BTSCS includes the following: (1) An individual motivational enhancement session during the first week of treatment to help participants think about individual reasons for smoking cessation; (2) Contingency management and goal-setting at the beginning of each session; (3) Skills for reducing smoking; (4) Social Skills Training; (5) Education about the biology of SPMI and smoking and the physiological harm caused by smoking; (5) Relapse prevention training; (6) Education about and assistance with nicotine replacement therapy for participants who are interested in learning about and trying it.
947436|NCT00960323|B1|Baseline|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
947437|NCT00960323|P1|Participant Flow|Colchicine, Atorvastatin, Colchicine and Atorvastatin|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast. On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg following an overnight fast.
947438|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
947439|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
947440|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
947441|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
947442|NCT00960323|O2|Outcome|Colchicine With Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
947443|NCT00960323|O1|Outcome|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast followed by a 14 day washout period.
947444|NCT00960323|E3|Reported Event|Colchicine and Atorvastatin|On the morning of Day 28, subjects received a co-administered single oral dose of colchicine 0.6 mg and atorvastatin 40 mg after an overnight fast.
947445|NCT00960323|E2|Reported Event|Atorvastatin Alone|On the mornings of Days 15-27, subjects received a daily dose of atorvastatin 40 mg after an overnight fast.
947446|NCT00960323|E1|Reported Event|Colchicine Alone|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period.
947447|NCT00960297|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
947448|NCT00960297|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
947449|NCT00960297|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
947450|NCT00960297|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab|"Preoperative chemotherapy and bevacizumab~Bevacizumab : Bevacizumab: 15 mg/kg, given IV on Days 1, 22, and 43 (Note: bevacizumab will not be dosed on Day 64 prior to surgery)~Paclitaxel : Paclitaxel: 200 mg/m2, given IV on Days 1, 22, 43, and 64~Carboplatin : Carboplatin: AUC=6, given IV on Days 1, 22, 43, and 64"
947451|NCT00960206|B4|Baseline|Total|Total of all reporting groups
947452|NCT00960206|B3|Baseline|Control|Howmedica Osteonics Omnifit Series II Cup Inserts/Omnifit PSL Microstructured Shell
947453|NCT00960206|B2|Baseline|ABC System|Howmedica Osteonics Alumina Insert/either PSL Microstructured or Secur Fit HA PSL Shell
947454|NCT00960206|B1|Baseline|Trident System|Trident Ceramic Insert/Trident AD with PureFix HA Shell
947455|NCT00960206|P3|Participant Flow|Control|Hip received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
947458|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
947459|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
947460|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
947461|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
947462|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
947463|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
947464|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
947465|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
947466|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
947467|NCT00960206|O3|Outcome|Control|Hip recevied the Omnifit Acetabular system with polyethylene insert and metal femoral head.
947468|NCT00960206|O2|Outcome|ABC System|Hip received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
947469|NCT00960206|O1|Outcome|Trident® System|Hip received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
947470|NCT00960206|E4|Reported Event|All Participants|All participants combined.
947471|NCT00960206|E3|Reported Event|Control|Hips that received the Omnifit Acetabular system with polyethylene insert and metal femoral head.
947472|NCT00960206|E2|Reported Event|ABC System|Hips that received the ABC Acetabular System with a ceramic insert and ceramic femoral head.
947473|NCT00960206|E1|Reported Event|Trident® System|Hips that received the Trident® Acetabular System with a ceramic insert and ceramic femoral head.
947474|NCT00960193|B1|Baseline|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
947475|NCT00960193|P1|Participant Flow|Colchicine Alone, Colchicine With Seville Orange Juice|On the morning of Day 1, subjects received a single dose of colchicine 0.6 mg after an overnight fast, followed by a 14 day washout period. On Days 15-17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. On Day 18, subjects received one dose of colchicine 0.6 mg in the morning along with a 240 ml serving of Seville orange juice. Subjects received a final 240 ml serving of Seville orange juice in the evening on Day 18.
947476|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
947477|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
947478|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
947479|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
947480|NCT00960193|O2|Outcome|Colchicine With Seville Orange Juice|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening. Then, on Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice in the morning after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
947481|NCT00960193|O1|Outcome|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 after an overnight fast, followed by a washout period of 14 days.
947547|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
947482|NCT00960193|E3|Reported Event|Colchicine With Seville Orange Juice|On Day 18, each subject received one 0.6 mg colchicine tablet and one 240 ml serving of Seville orange juice after an overnight fast. A final 240 ml serving of Seville orange juice was administered in the evening on Day 18.
947483|NCT00960193|E2|Reported Event|Seville Orange Juice Alone|On Days 15 to 17, each subject received one 240 ml serving of Seville orange juice in the morning and evening.
947484|NCT00960193|E1|Reported Event|Colchicine Alone|Each subject received one 0.6 mg colchicine tablet on Day 1 at after an overnight fast, followed by a washout period of 14 days.
947485|NCT00960154|B3|Baseline|Total|Total of all reporting groups
947486|NCT00960154|B2|Baseline|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
947487|NCT00960154|B1|Baseline|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
947488|NCT00960154|P2|Participant Flow|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
947489|NCT00960154|P1|Participant Flow|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
947490|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
947491|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
947492|NCT00960154|O2|Outcome|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
947493|NCT00960154|O1|Outcome|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
947494|NCT00960154|E2|Reported Event|Standard of Care (SOC)|The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
947495|NCT00960154|E1|Reported Event|PlasmaBlade|The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
947496|NCT00960141|B4|Baseline|Total|Total of all reporting groups
947497|NCT00960141|B3|Baseline|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947498|NCT00960141|B2|Baseline|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947499|NCT00960141|B1|Baseline|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947500|NCT00960141|P3|Participant Flow|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947501|NCT00960141|P2|Participant Flow|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947502|NCT00960141|P1|Participant Flow|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947503|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947504|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947505|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947506|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947507|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947508|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947509|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947510|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947511|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947512|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947513|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947514|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947515|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947516|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947517|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947518|NCT00960141|O3|Outcome|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947519|NCT00960141|O2|Outcome|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947520|NCT00960141|O1|Outcome|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947521|NCT00960141|E3|Reported Event|Loratadine|Montelukast matching-image placebo tablet and Loratadine 10 mg tablet orally once daily at bedtime for 2 weeks.
947522|NCT00960141|E2|Reported Event|Montelukast|Montelukast 10 mg tablet and Loratadine matching-image placebo tablet orally once daily at bedtime for 2 weeks.
947523|NCT00960141|E1|Reported Event|Placebo|Montelukast matching-image and Loratadine matching-image placebo tablets orally once daily at bedtime for 2 weeks
947524|NCT00960115|B3|Baseline|Total|Total of all reporting groups
947546|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
947525|NCT00960115|B2|Baseline|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
947526|NCT00960115|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
947527|NCT00960115|P2|Participant Flow|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
947528|NCT00960115|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram [mcg]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until progressive disease (PD) was documented.
948215|NCT00958243|B5|Baseline|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
947529|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
947530|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
947531|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
947532|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
947533|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
947534|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
947535|NCT00960115|O2|Outcome|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
947536|NCT00960115|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
947537|NCT00960115|E2|Reported Event|Placebo + Saline|Single dose of saline (sodium chloride, 9 grams per liter [g/L]) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with placebo doses matched to tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo were administered every 6 weeks until PD was documented.
947538|NCT00960115|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) were administered every 6 weeks until PD was documented.
947539|NCT00960076|B3|Baseline|Total|Total of all reporting groups
947540|NCT00960076|B2|Baseline|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
947541|NCT00960076|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
947542|NCT00960076|P2|Participant Flow|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
947543|NCT00960076|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
947548|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
947549|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
947550|NCT00960076|O2|Outcome|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
947551|NCT00960076|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
947552|NCT00960076|E2|Reported Event|Metformin (DB) + Metformin (OL)|Metformin XR 500 mg (DB) + Metformin XR 1500 mg (OL)
947553|NCT00960076|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg (DB) + Metformin XR 1500 mg (OL)
947554|NCT00960063|B4|Baseline|Total|Total of all reporting groups
947555|NCT00960063|B3|Baseline|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947556|NCT00960063|B2|Baseline|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947557|NCT00960063|B1|Baseline|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947558|NCT00960063|P3|Participant Flow|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947559|NCT00960063|P2|Participant Flow|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947560|NCT00960063|P1|Participant Flow|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day intravenously (IV) on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947561|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947562|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947563|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947564|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947565|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947566|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947567|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947568|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947569|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947570|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947571|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947572|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947573|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947574|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947575|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947576|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947577|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947578|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947579|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947580|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947581|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947582|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947583|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947584|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947585|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947586|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947587|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947588|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947589|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947590|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947591|NCT00960063|O3|Outcome|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947592|NCT00960063|O2|Outcome|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947593|NCT00960063|O1|Outcome|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947594|NCT00960063|E3|Reported Event|Ifosfamide+Etoposide+Robatumumab|Participants receive ifosfamide 1800 mg/m^2 per day IV PLUS etoposide 100 mg/m^2 per day IV on Days 1-5 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947595|NCT00960063|E2|Reported Event|Vincristine+Doxorubicin+Cyclophosphamide+Robatumumab|Participants receive vincristine 2 mg/m^2 (maximum 2 mg) IV on Day 1 PLUS cyclophosphamide 1200 mg/m^2 IV on Day 1 PLUS doxorubicin hydrochloride 75 mg/m^2 IV continuously over 48 hours PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947596|NCT00960063|E1|Reported Event|Temozolomide+Irinotecan+Robatumumab|Participants receive temozolomide 100 mg/m^2/day IV on Days 1-5 PLUS irinotecan 10 mg/m^2/day IV on Days 1-5 and Days 8-12 PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 3-week cycle.
947597|NCT00959985|B5|Baseline|Total|Total of all reporting groups
947598|NCT00959985|B4|Baseline|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947599|NCT00959985|B3|Baseline|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947600|NCT00959985|B2|Baseline|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947601|NCT00959985|B1|Baseline|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947602|NCT00959985|P4|Participant Flow|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947603|NCT00959985|P3|Participant Flow|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947604|NCT00959985|P2|Participant Flow|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947605|NCT00959985|P1|Participant Flow|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947606|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947721|NCT00959907|B1|Baseline|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
947607|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947608|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947609|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947610|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947611|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947612|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947613|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947614|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947615|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947616|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947617|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947618|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947619|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947620|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947621|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947622|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947623|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947624|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947625|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947626|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947627|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947628|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947629|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947630|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947631|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947632|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947633|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947634|NCT00959985|O4|Outcome|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947635|NCT00959985|O3|Outcome|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947636|NCT00959985|O2|Outcome|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947637|NCT00959985|O1|Outcome|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947638|NCT00959985|E4|Reported Event|Group 2B|"Moderate Lymphedema: Fitted with compression sleeve and instructed to wear a short-stretch compression bandage~Compression Sleeve: Worn for a minimum of 12 hours per day~Short-Stretch Compression Bandage: Worn overnight at least 5 nights of the week"
947639|NCT00959985|E3|Reported Event|Group 2A|"Moderate lymphedema: Fitted with a compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947640|NCT00959985|E2|Reported Event|Group 1B|"Mild Lymphedema: Fitted for compression sleeve~Compression Sleeve: Worn for a minimum of 12 hours per day"
947641|NCT00959985|E1|Reported Event|Group 1A|Mild Lymphedema: Only required to meet with the lymphedema physical therapist
947642|NCT00959946|B9|Baseline|Total|Total of all reporting groups
947643|NCT00959946|B8|Baseline|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947644|NCT00959946|B7|Baseline|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947783|NCT00959751|P1|Participant Flow|Placebo|3 x capsules, PRN
947645|NCT00959946|B6|Baseline|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947646|NCT00959946|B5|Baseline|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947647|NCT00959946|B4|Baseline|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947648|NCT00959946|B3|Baseline|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947649|NCT00959946|B2|Baseline|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
948216|NCT00958243|B4|Baseline|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
947650|NCT00959946|B1|Baseline|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
947651|NCT00959946|P8|Participant Flow|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947652|NCT00959946|P7|Participant Flow|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947653|NCT00959946|P6|Participant Flow|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947654|NCT00959946|P5|Participant Flow|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947655|NCT00959946|P4|Participant Flow|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947656|NCT00959946|P3|Participant Flow|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947657|NCT00959946|P2|Participant Flow|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947658|NCT00959946|P1|Participant Flow|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
947659|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947660|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947661|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947662|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947663|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947664|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947665|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947849|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
947666|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947667|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947668|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947669|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947670|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947671|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947672|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947673|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947674|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947675|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947693|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947784|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
947676|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947677|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947678|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947679|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947680|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947681|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947682|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947683|NCT00959946|O4|Outcome|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947684|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947685|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947686|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
947687|NCT00959946|O2|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER-|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor negative (ER-) and/or progesterone receptor negative (PgR-) and human epidermal growth factor receptor 2 negative (erbB2-).
947688|NCT00959946|O1|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 2): ER+|Bosutinib 300 mg orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle, until disease progression, intolerable toxicity, or withdrawal of consent in participants with locally advanced or metastatic breast cancer having estrogen receptor positive (ER+) and/or progesterone receptor positive (PgR+) and human epidermal growth factor receptor 2 negative (erbB2-).
947689|NCT00959946|O8|Outcome|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947690|NCT00959946|O7|Outcome|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947691|NCT00959946|O6|Outcome|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947692|NCT00959946|O5|Outcome|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947718|NCT00959920|E1|Reported Event|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
947719|NCT00959907|B3|Baseline|Total|Total of all reporting groups
947694|NCT00959946|O3|Outcome|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947695|NCT00959946|O2|Outcome|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947696|NCT00959946|O1|Outcome|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
947697|NCT00959946|O3|Outcome|Bosutinib + Capecitabine 1000 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 1000 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
948217|NCT00958243|B3|Baseline|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
947698|NCT00959946|O2|Outcome|Bosutinib + Capecitabine 750 mg/m^2|Bosutinib 200 mg, 300 mg, or 400 mg tablet administered orally once daily in a 21-day cycle. Capecitabine 750 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947699|NCT00959946|O1|Outcome|Bosutinib + Capecitabine 625 mg/m^2|Bosutinib 200 mg, or 300 mg, tablet administered orally once daily in a 21-day cycle. Capecitabine 625 mg/m^2 tablet administered orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947700|NCT00959946|E8|Reported Event|Bosutinib 400 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947701|NCT00959946|E7|Reported Event|Bosutinib 400 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 400 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947702|NCT00959946|E6|Reported Event|Bosutinib 300 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947703|NCT00959946|E5|Reported Event|Bosutinib 300 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947704|NCT00959946|E4|Reported Event|Bosutinib 300 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 300 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947705|NCT00959946|E3|Reported Event|Bosutinib 200 mg + Capecitabine 1000 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947706|NCT00959946|E2|Reported Event|Bosutinib 200 mg + Capecitabine 750 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 750 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, intolerable toxicity, or withdrawal of consent.
947707|NCT00959946|E1|Reported Event|Bosutinib 200 mg + Capecitabine 625 mg/m^2 (Part 1)|Bosutinib 200 mg tablet orally once daily in a 21-day cycle along with capecitabine 625 mg/m^2 tablet orally twice daily from Day 1 to 14, followed by 7 days off treatment in a 21-day cycle. Treatment was continued until disease progression, unacceptable toxicity, or withdrawal of consent.
947708|NCT00959920|B3|Baseline|Total|Total of all reporting groups
947709|NCT00959920|B2|Baseline|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
947710|NCT00959920|B1|Baseline|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
947711|NCT00959920|P2|Participant Flow|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
947712|NCT00959920|P1|Participant Flow|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
947713|NCT00959920|O2|Outcome|Intermittent Straight Catheterization|"Intermittent straight catheterization will be performed as needed during labor.~Intermittent straight catheterization: intermittent straight catheterization will be performed on an as needed basis until time of delivery."
947714|NCT00959920|O1|Outcome|Indwelling Foley Catheter|"Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.~Indwelling catheter: Indwelling bladder catheter will remain in place until time of delivery."
947715|NCT00959920|O2|Outcome|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
947716|NCT00959920|O1|Outcome|Indwelling Foley Catheter|Insertion of an indwelling foley catheter when bladder emptying is necessary. The indwelling catheter will remain in place until the time of delivery.
947717|NCT00959920|E2|Reported Event|Intermittent Straight Catheterization|Intermittent straight catheterization will be performed as needed during labor.
947720|NCT00959907|B2|Baseline|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
947722|NCT00959907|P2|Participant Flow|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
947723|NCT00959907|P1|Participant Flow|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
947724|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
947725|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
947726|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
947727|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
947728|NCT00959907|O2|Outcome|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
947729|NCT00959907|O1|Outcome|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
947730|NCT00959907|E2|Reported Event|BoNT-A2(2U)|Group 2: Botulinum toxin A (Botox®) will be administered 2 units of Botox®
947731|NCT00959907|E1|Reported Event|BoNT A1(4U)|Group 1: Botulinum toxin A (Dysport®) will be administered 4 units of Dysport®
948871|NCT00957047|O7|Outcome|TEAE Leading to Death|
947732|NCT00959894|B1|Baseline|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947733|NCT00959894|P1|Participant Flow|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947734|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day~Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947735|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day~Truvada: Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947736|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947737|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947738|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947739|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947740|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947741|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947742|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947743|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947744|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947745|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947746|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947785|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
947786|NCT00959751|O2|Outcome|Placebo|3 x 0 mg capsules, PRN
947787|NCT00959751|O1|Outcome|NXN-188 600 mg|3 x 200 mg capsules, PRN
947747|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947748|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947749|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947805|NCT00959699|P2|Participant Flow|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947750|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947751|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947752|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947753|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947754|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947755|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947756|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947757|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947758|NCT00959894|O1|Outcome|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947759|NCT00959894|E1|Reported Event|Etravirine 400 mg Once Daily|"Etravirine 400 mg once daily with fixed dose tenofovir/emtricitabine (Truvada) one tablet once daily~Etravirine (Intelence): Etravirine 400 mg (four 100 mg or two 200 mg tablets) taken orally once a day with one pill of Truvada (200 mg of emtricitabine and 300 mg of tenofovir) taken orally once a day"
947760|NCT00959764|B4|Baseline|Total|Total of all reporting groups
947761|NCT00959764|B3|Baseline|Placebo|Patients who did not receive any active treatment
947762|NCT00959764|B2|Baseline|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
947763|NCT00959764|B1|Baseline|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
947764|NCT00959764|P3|Participant Flow|Placebo|Patients who did not receive any active treatment
947765|NCT00959764|P2|Participant Flow|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
947766|NCT00959764|P1|Participant Flow|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
947767|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
947768|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
947769|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
947770|NCT00959764|O3|Outcome|Placebo|Patients who did not receive any active treatment
947771|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
947772|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
947773|NCT00959764|O3|Outcome|Placebo|Patients who were provided nasal and oral placebo medication in a blinded fashion
947774|NCT00959764|O2|Outcome|Nasal Calcitonin|Patients who were provided active nasal calcitonin and placebo oral medication in a blinded fashion.
947775|NCT00959764|O1|Outcome|Oral Calcitonin|Patients who were provided active oral calcitonin and placebo nasal medication in a blinded fashion.
947776|NCT00959764|E3|Reported Event|Placebo|Patients who did not receive any active treatment
947777|NCT00959764|E2|Reported Event|Nasal Calcitonin|Patients who only received nasal calcitonin as active treatment
947778|NCT00959764|E1|Reported Event|Oral Calcitonin|Patients who only received oral calcitonin as an active treatment
947779|NCT00959751|B3|Baseline|Total|Total of all reporting groups
947780|NCT00959751|B2|Baseline|Placebo|3 x 0 mg capsules
947781|NCT00959751|B1|Baseline|NXN-188|3 x 200 mg capsules
947782|NCT00959751|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules, PRN
947801|NCT00959751|E1|Reported Event|NXN-188 600 mg|3 x 200 mg capsules, PRN
947802|NCT00959699|B3|Baseline|Total|Total of all reporting groups
947803|NCT00959699|B2|Baseline|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947804|NCT00959699|B1|Baseline|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
948218|NCT00958243|B2|Baseline|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
947806|NCT00959699|P1|Participant Flow|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947807|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947808|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947809|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947810|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947811|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947812|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947813|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947814|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947815|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947816|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947817|NCT00959699|O2|Outcome|PegIFN-2b + RBV + Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947818|NCT00959699|O1|Outcome|PegIFN-2b + RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947819|NCT00959699|E3|Reported Event|Boceprevir Crossover|(After Treatment Week 24) PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) plus boceprevir (800 mg, orally, 3 times per day) for up to 44 weeks with 24 weeks post-treatment follow-up.
947820|NCT00959699|E2|Reported Event|PegIFN-2b+RBV+Boceprevir|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600- 1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by boceprevir (800 mg, orally, 3 times per day) plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up.
947821|NCT00959699|E1|Reported Event|PegIFN-2b+RBV|PegIFN-2b (1.5 µg/kg/week subcutaneously) plus RBV (600-1400 mg/day, orally, divided into two daily doses) for 4 weeks followed by placebo to boceprevir plus PegIFN-2b/RBV for 44 weeks with 24 weeks post-treatment follow-up (Control Arm). Participants who do not achieve HCV-RNA <9.3 IU/mL by Treatment Week 24 (TW24) are eligible to cross-over and receive boceprevir along with the PegIFN-2b and RBV for up to 44 weeks.
947822|NCT00959647|B1|Baseline|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
947823|NCT00959647|P1|Participant Flow|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
947848|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
948219|NCT00958243|B1|Baseline|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
947824|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
947825|NCT00959647|O1|Outcome|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
947826|NCT00959647|E1|Reported Event|Vismodegib 150 mg|Participants received 150 mg vismodegib orally once a day until disease progression, intolerable toxicity, or withdrawal from the study. If a participant had been receiving combination chemotherapy and/or biotherapy (FOLFOX, FOLFIRI, bevacizumab) in a parent study, the same combination chemotherapy and/or biotherapy as specified in the parent study could be continued in this study at the discretion of the investigator.
947827|NCT00959374|B1|Baseline|V-loc and Monocryl|All randomized subjects
947828|NCT00959374|P1|Participant Flow|V-loc and Monocryl|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
947829|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
947830|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
947831|NCT00959374|O2|Outcome|3-0 Monocryl Sutures|Each Subject served as their own control and was randomized to which side of the body received the control sutures. The control side included mandatory closure of the deep dermal layer with interrupted 3-0 Monocryl(TM)sutures, spaced no further than 2cm apart, followed by closure of the intradermal layer with running 3-0 Monocryl(TM) sutures.
947832|NCT00959374|O1|Outcome|V-Loc 180 / 90 Wound Closure Device|Each subject served as their own control and was randomized as to which side of the body received the test procedure. On the test closure side, the investigator could elect not to close the deep dermal layer, but if the deep dermal layer was closed, interrupted 3-0 Monocryl(TM) sutures were required to be placed no more than 5cm apart. Following optional closure of deep dermal layer, the intradermal layer was closed with running V-Loc(TM)90 or 180 device. The study was initiated with V-Loc(TM)180 as the only test device and V-Loc(TM)90 was added via protocol amendment 13Apr2010.
947833|NCT00959374|E4|Reported Event|Non-protocol Incision or Systemic Events|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at either a non-protocol incision or were systemic in nature.
947834|NCT00959374|E3|Reported Event|Midline|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side. Events in this group occurred at midline incision and therefore not assigned to a treatment arm.
947835|NCT00959374|E2|Reported Event|Control - Monocryl 3-0|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
947836|NCT00959374|E1|Reported Event|V-Loc 180 / 90|Within-patient study. Each patient received either V-Loc 180 or 90 on one side and the control suture (3-0 Monocryl)on the other side.
947837|NCT00959192|B5|Baseline|Total|Total of all reporting groups
947838|NCT00959192|B4|Baseline|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947839|NCT00959192|B3|Baseline|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947840|NCT00959192|B2|Baseline|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947841|NCT00959192|B1|Baseline|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947842|NCT00959192|P4|Participant Flow|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947843|NCT00959192|P3|Participant Flow|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947844|NCT00959192|P2|Participant Flow|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947845|NCT00959192|P1|Participant Flow|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947846|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947847|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947850|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947851|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947852|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947853|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
947854|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947855|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947856|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947857|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
947858|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947859|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947860|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947861|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947862|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947863|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947864|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947865|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
947866|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947867|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947868|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947869|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947870|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947871|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947872|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947873|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
947874|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947875|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947876|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947877|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 3, 6, 9 and 12
947878|NCT00959192|O4|Outcome|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947879|NCT00959192|O3|Outcome|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947880|NCT00959192|O2|Outcome|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947881|NCT00959192|O1|Outcome|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947882|NCT00959192|E4|Reported Event|QS-21|A cohort of participants who received IM injection of adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947883|NCT00959192|E3|Reported Event|ACC-001 30 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (30 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
948280|NCT00958217|B3|Baseline|Total|Total of all reporting groups
947884|NCT00959192|E2|Reported Event|ACC-001 10 Micrograms + QS-21|A cohort of participants who received IM injection of active vaccine ACC-001 (10 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947885|NCT00959192|E1|Reported Event|ACC-001 3 Micrograms + QS-21|A cohort of participants who received intramuscular (IM) injection of active vaccine ACC-001 (3 micrograms) + adjuvant QS-21 (50 micrograms) at Day 1, month 1, 3, 6 and 12
947886|NCT00959049|B7|Baseline|Total|Total of all reporting groups
947887|NCT00959049|B6|Baseline|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947888|NCT00959049|B5|Baseline|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947889|NCT00959049|B4|Baseline|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947890|NCT00959049|B3|Baseline|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947891|NCT00959049|B2|Baseline|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947892|NCT00959049|B1|Baseline|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
947893|NCT00959049|P6|Participant Flow|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947894|NCT00959049|P5|Participant Flow|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947895|NCT00959049|P4|Participant Flow|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947896|NCT00959049|P3|Participant Flow|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947897|NCT00959049|P2|Participant Flow|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947898|NCT00959049|P1|Participant Flow|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
947899|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
947900|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
947901|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
947902|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
947903|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
947904|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
947905|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 3 to < 9 years
947906|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years
947907|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
947908|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years
947909|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years
947910|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
947911|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947912|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947913|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947914|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947915|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947916|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
947917|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947918|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947919|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947920|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947921|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947922|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
947923|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947924|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947925|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947926|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947927|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947928|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
947929|NCT00959049|O6|Outcome|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947930|NCT00959049|O5|Outcome|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947931|NCT00959049|O4|Outcome|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947932|NCT00959049|O3|Outcome|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947933|NCT00959049|O2|Outcome|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947934|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
947935|NCT00959049|O2|Outcome|Fluzone Cohort C|Age 9 to < 18 years
947936|NCT00959049|O1|Outcome|Afluria Cohort C|Age 9 to < 18 years
947937|NCT00959049|O2|Outcome|Fluzone Cohort B|Age 3 to < 9 years
947938|NCT00959049|O1|Outcome|Afluria Cohort B|Age 3 to < 9 years
947939|NCT00959049|O2|Outcome|Fluzone Cohort A|Age 6 months to < 3 years
947940|NCT00959049|O1|Outcome|Afluria Cohort A|Age 6 months to < 3 years
947941|NCT00959049|E6|Reported Event|Fluzone Cohort C|Age 9 to < 18 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947942|NCT00959049|E5|Reported Event|Fluzone Cohort B|Age 3 to < 9 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947943|NCT00959049|E4|Reported Event|Fluzone Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Fluzone.
947944|NCT00959049|E3|Reported Event|Afluria Cohort C|Age 9 to < 18 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947945|NCT00959049|E2|Reported Event|Afluria Cohort B|Age 3 to < 9 years. Participants received one or two doses of the 2009/2010 influenza season formulation of Afluria.
947946|NCT00959049|E1|Reported Event|Afluria Cohort A|Age 6 months to < 3 years. Participants received one of two doses of the 2009/2010 influenza season formulation of Afluria.
947947|NCT00958919|B1|Baseline|Entire Study Population|Includes groups randomized to receive saline first and Naxolone first.
947948|NCT00958919|P2|Participant Flow|Naloxone First, Then Normal Saline|Intravenous Naloxone (10mg/25 ml)in first intervention period and intravenous saline (25 ml) in second intervention period.
947949|NCT00958919|P1|Participant Flow|Normal Saline First, Then Naloxone|Intravenous saline (25 ml) in first intervention period and intravenous Naloxone (10mg/25 ml) in second intervention period.
947950|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Normal Saline (25 ml)
947951|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Normal Saline (25 ml)
947952|NCT00958919|O2|Outcome|End of Resistance Load Breathing|End of Resistance Load Breathing post-infusion of Naloxone (10 mg/25 ml)
947953|NCT00958919|O1|Outcome|Baseline|Pre-infusion of Naloxone (10 mg/25 ml)
947954|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)given prior to start of Resistive Load Breathing
947955|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml) given prior to start of Resistive Load Breathing
947956|NCT00958919|O2|Outcome|Naloxone|Intravension Naloxone (10mg/25ml)
947957|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
947958|NCT00958919|O2|Outcome|Naloxone|Intravenous Naloxone (10mg/25ml)
947959|NCT00958919|O1|Outcome|Normal Saline|Intravenous saline (25 ml)
947960|NCT00958919|E2|Reported Event|Naloxone|10mg/25ml Intravenous
947961|NCT00958919|E1|Reported Event|Normal Saline|25 ml Intravenous
947962|NCT00958893|B1|Baseline|25 mg Proellex|25 mg Proellex daily
947963|NCT00958893|P1|Participant Flow|25 mg Proellex|25 mg Proellex: one 25 mg capsules
947964|NCT00958893|O1|Outcome|25 mg Proellex|25 mg Proellex: one 25 mg capsules
947965|NCT00958893|E1|Reported Event|25 mg Proellex|25 mg Proellex: one 25 mg capsules
947966|NCT00958880|B3|Baseline|Total|Total of all reporting groups
947967|NCT00958880|B2|Baseline|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
947968|NCT00958880|B1|Baseline|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
947969|NCT00958880|P2|Participant Flow|Yohimbine Hydrochloride|Participants received Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy. Participants received Yohimbine HCL augmented Group Cognitive Behavioral Therapy. The 10.8 mg pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
947970|NCT00958880|P1|Participant Flow|Sugar Pill|Participants received placebo (sugar pill) augmented Group Cognitive Behavioral Therapy. The pills were administered 1 hour prior to sessions 2-5 of a 5-session group exposure-based CBT protocol.
947971|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
947972|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
947973|NCT00958880|O2|Outcome|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
948177|NCT00958334|P2|Participant Flow|Proellex 12.5 mg|Proellex® 12.5 mg capsules orally QD
947974|NCT00958880|O1|Outcome|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
947975|NCT00958880|E2|Reported Event|Yohimbine Hydrochloride|Participants will receive Yohimbine Hydrochloride augmented Group Cognitive Behavioral Therapy
947976|NCT00958880|E1|Reported Event|Sugar Pill|Participants will receive placebo (sugar pill) augmented Group Cognitive Behavioral Therapy
947977|NCT00958841|B1|Baseline|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
948065|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
947978|NCT00958841|P1|Participant Flow|Pasireotide LAR 60mg|All patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase. Patients included patients with pancreatic neuroendocrine tumors (PNETs), pituitary NETs (PiNETs), Ectopic ACTH-secreting tumor (EAS) & Nelson's syndrome.
947979|NCT00958841|O1|Outcome|Nelson's Syndrome|Nelson’s syndrome is associated with local tumor extension or invasion following a therapeutic bilateral adrenalectomy
947980|NCT00958841|O1|Outcome|All PiNETS (Prolactinoma)|One of the 10 types of PiNETs analyzed
947981|NCT00958841|O1|Outcome|All PNETS (Gastrinoma)|One of the 10 types of PNETs analyzed
947982|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
947983|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
947984|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
947985|NCT00958841|O3|Outcome|Nelson’s Syndrome|based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
947986|NCT00958841|O2|Outcome|Prolactinoma|One of the 10 types of PNETs analyzed.
947987|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
947988|NCT00958841|O3|Outcome|Glucagonoma|One of the 10 types of PNETs analyzed.
947989|NCT00958841|O2|Outcome|VIpoma|One of the 10 types of PNETs analyzed.
947990|NCT00958841|O1|Outcome|Gastrinoma|One of the 10 types of PNETs analyzed
947991|NCT00958841|E4|Reported Event|Nelsons Syndrome|Nelson's syndrome is based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48.
947992|NCT00958841|E3|Reported Event|Ectopic ACTH-secrting Tumors (EAS)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
947993|NCT00958841|E2|Reported Event|Pituitary NETs (PiNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
947994|NCT00958841|E1|Reported Event|Pancreatic NETs (PNETs)|Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
947995|NCT00958828|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
947996|NCT00958828|P2|Participant Flow|Narafilcon A / Nelfilcon A|Narafilcon A contact lenses, then Nelfilcon A contact lenses
947997|NCT00958828|P1|Participant Flow|Nelfilcon A / Narafilcon A|Nelfilcon A contact lenses, then Narafilcon A contact lenses
947998|NCT00958828|O2|Outcome|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
947999|NCT00958828|O1|Outcome|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
948000|NCT00958828|E2|Reported Event|Narafilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
948001|NCT00958828|E1|Reported Event|Nelfilcon A Contact Lens|Spherical, soft contact lens for daily disposable wear
948002|NCT00958789|B1|Baseline|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
948003|NCT00958789|P1|Participant Flow|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
948004|NCT00958789|O1|Outcome|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
948005|NCT00958789|E1|Reported Event|Triathlon TS Knee|Triathlon TS Knee System: Total knee replacement for revision cases
948006|NCT00958776|B3|Baseline|Total|Total of all reporting groups
948007|NCT00958776|B2|Baseline|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948008|NCT00958776|B1|Baseline|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948009|NCT00958776|P2|Participant Flow|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948010|NCT00958776|P1|Participant Flow|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948061|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
951338|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
948011|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948012|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948066|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948013|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948014|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948015|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948016|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948017|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948018|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948019|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948020|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948021|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948022|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948023|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948024|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948025|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948026|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948027|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948028|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948029|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948030|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948031|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948032|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948062|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948178|NCT00958334|P1|Participant Flow|Proellex 25 mg|Proellex® 12.5 mg orally capsules BID
948033|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948034|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948035|NCT00958776|O2|Outcome|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948036|NCT00958776|O1|Outcome|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948037|NCT00958776|E2|Reported Event|Peramivir+SOC|"Adults (≥ 18 years): Peramivir (BCX-1812) 600 mg, administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.~Adolescents (12-17 years): Peramivir (BCX-1812) 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care."
948038|NCT00958776|E1|Reported Event|Placebo+SOC|Placebo Peramivir (BCX1812) administered intravenously, once daily (every 24 hrs) for 5 days (5 doses) in addition to institution's standard of care.
948039|NCT00958568|B1|Baseline|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
948040|NCT00958568|P4|Participant Flow|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948041|NCT00958568|P3|Participant Flow|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
948042|NCT00958568|P2|Participant Flow|OFC (SPIII)|6 mg Olanzapine and 25 mg Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
948043|NCT00958568|P1|Participant Flow|OFC (SPII )|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
948044|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948045|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
948046|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948047|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948048|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948049|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948050|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948051|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948052|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948053|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948054|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948055|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948056|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948057|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948058|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948059|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948060|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948063|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948064|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948098|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948067|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948068|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948069|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948070|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948071|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948072|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948073|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948074|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948075|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948076|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948077|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948078|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948079|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948080|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948081|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948082|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948083|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948084|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948085|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948086|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948087|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948088|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948089|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948090|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948091|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948092|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948093|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948094|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948095|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948096|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948097|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948099|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948100|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
948101|NCT00958568|O1|Outcome|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
948102|NCT00958568|O1|Outcome|OFC (SPII-Wk 0-8, Acute Open-label)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
948103|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948104|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948105|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948106|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948107|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948108|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948109|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948110|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948111|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948112|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948113|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948114|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948115|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948116|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948117|NCT00958568|O2|Outcome|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948118|NCT00958568|O1|Outcome|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948119|NCT00958568|E4|Reported Event|Flu (SPIV)|Fluoxetine (Flu): 25 or 50 mg oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV).
948120|NCT00958568|E3|Reported Event|OFC (SPIV)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50, oral, daily, for 27 weeks during double-blind randomized relapse prevention treatment phase (SPIV). Fixed dosing.
948121|NCT00958568|E2|Reported Event|OFC (SPIII)|Olanzapine and Fluoxetine Combination (OFC): 6 mg Olanzapine and 25 mg Fluoxetine Combination (6/25), 12/25, 6/50, 12/50 or 18/50 oral, daily, for 12 weeks during open-label stabilization treatment phase (SPIII). Flexible dosing.
948122|NCT00958568|E1|Reported Event|OFC (SPII)|Olanzapine and Fluoxetine Combination (OFC): 3 milligram (mg) Olanzapine and 25 mg Fluoxetine Combination (3/25), 6/25, 12/25, 6/50, 12/50 or 18/50, oral, daily, for 6-8 weeks during open-label acute treatment phase (SPII). Flexible dosing with initial forced titration.
948123|NCT00958438|B4|Baseline|Total|Total of all reporting groups
948174|NCT00958334|B2|Baseline|Proellex 12.5 mg|Proellex® 12.5 mg once daily
948124|NCT00958438|B3|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948125|NCT00958438|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948126|NCT00958438|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948127|NCT00958438|P3|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948128|NCT00958438|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948129|NCT00958438|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948130|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948131|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948132|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948133|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948134|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948135|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948136|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948137|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948138|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948139|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948140|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948141|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948142|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948143|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948144|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948145|NCT00958438|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948146|NCT00958438|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948147|NCT00958438|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
948148|NCT00958438|E3|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
948149|NCT00958438|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
948150|NCT00958438|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
948151|NCT00958360|B3|Baseline|Total|Total of all reporting groups
948152|NCT00958360|B2|Baseline|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948153|NCT00958360|B1|Baseline|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948175|NCT00958334|B1|Baseline|Proellex 25 mg|Proellex® 12.5 mg twice daily
948176|NCT00958334|P3|Participant Flow|Placebo Comparator|Placebo capsules orally QD
948154|NCT00958360|P2|Participant Flow|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948155|NCT00958360|P1|Participant Flow|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948214|NCT00958243|B6|Baseline|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948872|NCT00957047|O6|Outcome|Serious TEAE|
948156|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948157|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948158|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948159|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948160|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948161|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948162|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948163|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948164|NCT00958360|O2|Outcome|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948165|NCT00958360|O1|Outcome|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948166|NCT00958360|E2|Reported Event|Basic Low Vision Care Group|"Basic Low Vision Care: Low vision examination, prescription and dispensing of low vision devices without low vision therapy or assigned homework.~Basic Low Vision Service: Service is provided by the optometrist alone and includes demonstration of low vision device use and maintenance of prescribed low vision devices, without low vision therapy or homework and with less contact time."
948167|NCT00958360|E1|Reported Event|Interdisciplinary Low Vision Rehabilitation Group|"Interdisciplinary Low Vision Rehabilitation: Low vision examination, prescription and dispensing of low vision devices, low vision therapy and homework.~Interdisciplinary Low Vision Service: Services are provided by optometrist(s) and low vision therapist(s), and include low vision therapy to improve use of remaining vision and low vision devices, and structured homework to practice use of low vision devices that are prescribed and dispensed."
948168|NCT00958347|B1|Baseline|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
948169|NCT00958347|P1|Participant Flow|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem.
948170|NCT00958347|O1|Outcome|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
948171|NCT00958347|E1|Reported Event|Omnifit HA Hip Stem|Omnifit HA Hip Stem: Total Hip Replacement with Omnifit HA Hip Stem
948172|NCT00958334|B4|Baseline|Total|Total of all reporting groups
948173|NCT00958334|B3|Baseline|Placebo Comparator|Placebo capsule once daily
948179|NCT00958334|O3|Outcome|Placebo Comparator|Placebo capsule once daily
948180|NCT00958334|O2|Outcome|Proellex 12.5 mg|Proellex® 12.5 mg once daily
948181|NCT00958334|O1|Outcome|Proellex 25 mg|Proellex® 12.5 mg twice daily
948182|NCT00958334|E3|Reported Event|Placebo Comparator|Placebo capsule once daily
948183|NCT00958334|E2|Reported Event|Proellex 12.5 mg|Proellex® 12.5 mg once daily
948184|NCT00958334|E1|Reported Event|Proellex 25 mg|Proellex® 12.5 mg twice daily
948185|NCT00958308|B4|Baseline|Total|Total of all reporting groups
948186|NCT00958308|B3|Baseline|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948187|NCT00958308|B2|Baseline|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948188|NCT00958308|B1|Baseline|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948189|NCT00958308|P3|Participant Flow|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948190|NCT00958308|P2|Participant Flow|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948191|NCT00958308|P1|Participant Flow|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948192|NCT00958308|O3|Outcome|BIO-K+ CL-1285|Two capsules of probiotic (each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948193|NCT00958308|O2|Outcome|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948194|NCT00958308|O1|Outcome|Placebo|Two capsules of placebo (devoid of microorganisms)per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948195|NCT00958308|E3|Reported Event|BIO-K+ CL-1285|Two capsules of probiotic(BIO-K+ CL-1285® - each capsule contains 50 billion CFU) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948196|NCT00958308|E2|Reported Event|BIO-K+ CL-1285® & Placebo|One capsule of probiotic (BIO-K+ CL-1285® with 50 billion colony forming units (CFU)) and one capsule of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948197|NCT00958308|E1|Reported Event|Placebo|Two capsules of placebo (devoid of microorganisms) per day. Patients took their daily dose 2h after breakfast and antibiotic administration each day. Patients were then followed for an additionnal 21 days after completion of the assigned intervention.
948198|NCT00958282|B3|Baseline|Total|Total of all reporting groups
948199|NCT00958282|B2|Baseline|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
948200|NCT00958282|B1|Baseline|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
948201|NCT00958282|P2|Participant Flow|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
948202|NCT00958282|P1|Participant Flow|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
948203|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
948204|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
948205|NCT00958282|O2|Outcome|Placebo|"Placebo Comparator once per day~placebo~cognitive behavioral therapy"
948206|NCT00958282|O1|Outcome|Lisdexamfetamine|"lisdexamfetamine 70mg/day~lisdexamfetamine~cognitive behavioral therapy"
948207|NCT00958282|E2|Reported Event|Placebo|"Placebo Comparator once per day~placebo"
948208|NCT00958282|E1|Reported Event|Lisdexamfetamine/Behavior Therapy|"lisdexamfetamine 70mg/day plus Behavior Therapy~lisdexamfetamine/Behavior Therapy"
948209|NCT00958256|B1|Baseline|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
948210|NCT00958256|P1|Participant Flow|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, Granulocyte-colony stimulating factor (G-CSF) 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
948265|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948266|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948211|NCT00958256|O1|Outcome|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
948212|NCT00958256|E1|Reported Event|Bortezomib With Cyclophosphamide and Rituximab|Bortezomib 1.3 mg/m^2 intravenously (IV) on Days 1, 4, 8, and 11 of the cycle; Cyclophosphamide 300 mg/m^2 IV every 12 hours on Days 2, 3, and 4, and Rituximab 375 mg/m^2 IV on Day 1. Mesna 600 mg/m^2 for 3 days, G-CSF 5 micrograms/kg subcutaneously daily for 7 days after last dose of Bortezomib. Cycles repeated every 21 days for up to six cycles.
948213|NCT00958243|B7|Baseline|Total|Total of all reporting groups
948873|NCT00957047|O5|Outcome|TEAE Leading to Discontinuation|
948220|NCT00958243|P6|Participant Flow|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948221|NCT00958243|P5|Participant Flow|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948222|NCT00958243|P4|Participant Flow|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948223|NCT00958243|P3|Participant Flow|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948224|NCT00958243|P2|Participant Flow|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948225|NCT00958243|P1|Participant Flow|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948226|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948227|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948228|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948229|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948230|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948231|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948232|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948233|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948234|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948235|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948236|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948237|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948238|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
948239|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
948240|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
948241|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948242|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948243|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948244|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948245|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948246|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948247|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948248|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948249|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948250|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948251|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948252|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948253|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose
948254|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose
948255|NCT00958243|O1|Outcome|Placebo Cohort B|Placebo
948256|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
948257|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
948258|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
948259|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose
948260|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose
948261|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo
948262|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948263|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948264|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948267|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948268|NCT00958243|O6|Outcome|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948269|NCT00958243|O5|Outcome|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948270|NCT00958243|O4|Outcome|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948271|NCT00958243|O3|Outcome|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948272|NCT00958243|O2|Outcome|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948273|NCT00958243|O1|Outcome|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948274|NCT00958243|E6|Reported Event|CSL425 (15 mcg) Cohort B|15 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948275|NCT00958243|E5|Reported Event|CSL425 (7.5 mcg) Cohort B|7.5 mcg of hemagglutinin antigen per dose, Aged 3 years to less than 9 years
948276|NCT00958243|E4|Reported Event|Placebo Cohort B|Placebo, Aged 3 years to less than 9 years
948277|NCT00958243|E3|Reported Event|CSL425 (15 mcg) Cohort A|15 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948278|NCT00958243|E2|Reported Event|CSL425 (7.5 mcg) Cohort A|7.5 mcg of hemagglutinin antigen per dose, Aged 6 months to less than 3 years
948279|NCT00958243|E1|Reported Event|Placebo Cohort A|Placebo, Aged 6 months to less than 3 years
948281|NCT00958217|B2|Baseline|Arm 2: ICBT|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) were recruited.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
948282|NCT00958217|B1|Baseline|Arm 1: CPT-M|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) were recruited.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
948283|NCT00958217|P2|Participant Flow|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
948284|NCT00958217|P1|Participant Flow|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
948285|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
948286|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
948287|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
948288|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
948289|NCT00958217|O2|Outcome|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
948290|NCT00958217|O1|Outcome|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
948291|NCT00958217|E3|Reported Event|ICBT Prior to Randomization|"All participants attended 12 weeks of group Integrated Cognitive Behavioral Therapy prior to randomization to provide for a period of stabilization and to develop relapse prevention and mood management skills.~This portion will report on only those participants who were not randomized to individual CPT-M or ICBT."
948292|NCT00958217|E2|Reported Event|Arm 2: Integrated Cognitive Behavioral Therapy|"Individuals with depression and substance disorders and trauma history (with and without a PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~ICBT: Integrated Cognitive Behavioral Therapy: Psychotherapy that focuses on thoughts and behaviors that are associated with depression and substance relapse with the goal of developing skills to reduce depression and substance relapse"
948293|NCT00958217|E1|Reported Event|Arm 1: Cognitive Processing Therapy- Modified|"Individuals with depression and substance disorders and trauma history (with and without PTSD diagnosis) are randomized to receive one of two psychotherapy interventions.~CPT-M: Cognitive Processing Therapy-Modified: Psychotherapy that focuses on thoughts associated with traumatic experiences with the goal of developing skills to reduce trauma-related symptoms. We have modified this therapy to include substance relapse prevention skills."
948294|NCT00958191|B1|Baseline|Trident® X3 Polyethylene Insert|All subjects who recieved the Trident X3 insert.
948295|NCT00958191|P1|Participant Flow|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 polyetheylene insert can have one or both hips replaced. If both hips were replaced, but one hip completed the primary endpoint, the participant is counted as completed.
948296|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948297|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948298|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948299|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948300|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948301|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948302|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948303|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948304|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received the Trident® X3 Polyethylene Insert.
948305|NCT00958191|O1|Outcome|Trident® X3 Polyethylene Insert|Participants who received theTrident® X3 Polyethylene Insert
948306|NCT00958191|E1|Reported Event|Trident® X3 Polyethylene Insert|Participants who received the Trident X3 Polyethylene Insert
948307|NCT00958165|B1|Baseline|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
948308|NCT00958165|P1|Participant Flow|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
948309|NCT00958165|O1|Outcome|EAS-AC|Pulmonary vein isolation treatment with EAS-AC for PAF
948310|NCT00958165|E1|Reported Event|EAS-AC|"PVI with EAS-AC~CardioFocus EAS-AC: PVI for PAF"
948311|NCT00958126|B9|Baseline|Total|Total of all reporting groups
948312|NCT00958126|B8|Baseline|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948313|NCT00958126|B7|Baseline|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948314|NCT00958126|B6|Baseline|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948315|NCT00958126|B5|Baseline|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948316|NCT00958126|B4|Baseline|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948317|NCT00958126|B3|Baseline|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948318|NCT00958126|B2|Baseline|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948319|NCT00958126|B1|Baseline|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948320|NCT00958126|P8|Participant Flow|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948321|NCT00958126|P7|Participant Flow|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948322|NCT00958126|P6|Participant Flow|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948323|NCT00958126|P5|Participant Flow|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948324|NCT00958126|P4|Participant Flow|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948325|NCT00958126|P3|Participant Flow|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948326|NCT00958126|P2|Participant Flow|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948327|NCT00958126|P1|Participant Flow|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948328|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Age Cohorts Combined|30 mcg of hemagglutinin antigen per dose
948329|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Age Cohorts Combined|15 mcg of hemagglutinin antigen per dose
948330|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Age Cohorts Combined|7.5 mcg of hemagglutinin antigen per dose
948331|NCT00958126|O1|Outcome|Placebo, Age Cohorts Combined|Vaccine diluent
948332|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948333|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948334|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948335|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948336|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948337|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948338|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948339|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948340|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948341|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948342|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948343|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948344|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948345|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948346|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948347|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948348|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948349|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948350|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948351|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948352|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948353|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948354|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948355|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948356|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948357|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948358|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948359|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948360|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948361|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948362|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948363|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948364|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948365|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948366|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948367|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948368|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948369|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948370|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948371|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948372|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948373|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948374|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948375|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948376|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948377|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948378|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948379|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948380|NCT00958126|O8|Outcome|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948381|NCT00958126|O7|Outcome|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948382|NCT00958126|O6|Outcome|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948383|NCT00958126|O5|Outcome|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948384|NCT00958126|O4|Outcome|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948385|NCT00958126|O3|Outcome|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948386|NCT00958126|O2|Outcome|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948387|NCT00958126|O1|Outcome|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948388|NCT00958126|E8|Reported Event|CSL425 (30 Mcg), Older Adults|30 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948389|NCT00958126|E7|Reported Event|CSL425 (15 Mcg), Older Adults|15 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948390|NCT00958126|E6|Reported Event|CSL425 (7.5 Mcg), Older Adults|7.5 mcg of hemagglutinin antigen per dose; Older adults aged 65 years or older
948391|NCT00958126|E5|Reported Event|Placebo, Older Adults|Vaccine diluent; Older adults aged 65 years or older
948392|NCT00958126|E4|Reported Event|CSL425 (30 Mcg), Adults|30 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948393|NCT00958126|E3|Reported Event|CSL425 (15 Mcg), Adults|15 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948394|NCT00958126|E2|Reported Event|CSL425 (7.5 mcg), Adults|7.5 mcg of hemagglutinin antigen per dose; Adults aged 18 to 64 years
948395|NCT00958126|E1|Reported Event|Placebo, Adults|Vaccine diluent; Adults aged 18 to 64 years
948396|NCT00958074|B3|Baseline|Total|Total of all reporting groups
948445|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948446|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948397|NCT00958074|B2|Baseline|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948398|NCT00958074|B1|Baseline|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948399|NCT00958074|P2|Participant Flow|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948400|NCT00958074|P1|Participant Flow|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948484|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948874|NCT00957047|O4|Outcome|Treatment-related TEAE|
948401|NCT00958074|O2|Outcome|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948402|NCT00958074|O1|Outcome|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948403|NCT00958074|E2|Reported Event|Cohort II (<65 Years Old)|"400 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948404|NCT00958074|E1|Reported Event|Cohort I (>=65 Years Old)|"200 mg vorinostat PO QD on days 1-28. Treatment repeats every 28 days for 6 courses. Dose escalation by 100mg per day increments to maximum dose of 500mg per day in the absence of dose limiting toxicity.~vorinostat: Given PO~flow cytometry: correlative study~laboratory biomarker analysis: correlative study"
948405|NCT00958035|B3|Baseline|Total|Total of all reporting groups
948406|NCT00958035|B2|Baseline|Placebo|vehicle sterile solution
948407|NCT00958035|B1|Baseline|LATISSE®|bimatoprost ophthalmic 0.03% solution
948408|NCT00958035|P2|Participant Flow|Placebo|vehicle sterile solution
948409|NCT00958035|P1|Participant Flow|LATISSE®|bimatoprost ophthalmic 0.03% solution
948410|NCT00958035|O2|Outcome|Placebo|vehicle sterile solution
948411|NCT00958035|O1|Outcome|LATISSE®|bimatoprost ophthalmic 0.03% solution
948412|NCT00958035|E2|Reported Event|Placebo|vehicle sterile solution
948413|NCT00958035|E1|Reported Event|LATISSE®|bimatoprost ophthalmic 0.03% solution
948414|NCT00958009|B1|Baseline|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
948415|NCT00958009|P1|Participant Flow|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
948416|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
948417|NCT00958009|O1|Outcome|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
948418|NCT00958009|E1|Reported Event|RMS Subject Disposition|Intent to Treat Analysis (ITT) includes all subjects who provide written informed consent and received at least one dose of trial medication
948419|NCT00957996|B3|Baseline|Total|Total of all reporting groups
948420|NCT00957996|B2|Baseline|Peramivir 600mg|"600 mg once daily~Peramivir: 600 mg once daily"
948421|NCT00957996|B1|Baseline|Peramivir 300mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
948422|NCT00957996|P2|Participant Flow|Peramivir 600 mg|Peramivir 600 mg once daily
948423|NCT00957996|P1|Participant Flow|Peramivir 300 mg|Peramivir 300 mg twice daily
948424|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948425|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948426|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
948427|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
948428|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948429|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948430|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948431|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948432|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948433|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948434|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948435|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948436|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948437|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948438|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948439|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948440|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948441|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948442|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
948443|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
948444|NCT00957996|O2|Outcome|Peramivir 600 mg|Peramivir 600 mg once daily
948447|NCT00957996|O1|Outcome|Peramivir 300 mg|Peramivir 300 mg twice daily
948448|NCT00957996|O2|Outcome|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
948449|NCT00957996|O1|Outcome|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
948450|NCT00957996|E2|Reported Event|Peramivir 600 mg|"600 mg once daily~Peramivir: 600 mg once daily"
948451|NCT00957996|E1|Reported Event|Peramivir 300 mg|"300 mg twice daily~Peramivir: 300 mg twice daily"
948452|NCT00957944|B3|Baseline|Total|Total of all reporting groups
948453|NCT00957944|B2|Baseline|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
948454|NCT00957944|B1|Baseline|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
948875|NCT00957047|O3|Outcome|TEAE With Onset After 1st 4 Weeks|
948455|NCT00957944|P2|Participant Flow|Sequence B-A (Reference: PR 2.1.1 AND - Test: PR 2.1.1 WCL)|Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in first intervention period and Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in second intervention period (after washout period of at least 5 days)
948456|NCT00957944|P1|Participant Flow|Sequence A-B (Test: PR 2.1.1 WCL - Reference: PR 2.1.1 AND)|Treatment A (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS West Caldwell, USA) in first intervention period and Treatment B (Rotigotine transdermal patch 4.5 mg/10 cm^2 manufactured at LTS Andernach, Germany) in second intervention period (after washout period of at least 5 days)
948457|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948458|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948459|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948460|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948461|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948462|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948463|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948464|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948465|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948466|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948467|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948468|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948469|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948470|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948471|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948472|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948473|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948474|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948475|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948476|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948477|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948513|NCT00957684|B1|Baseline|ESL 1200 mg|400-mg + 800-mg; once daily administration by oral route
948478|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948479|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948480|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948481|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948482|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948483|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948485|NCT00957944|O2|Outcome|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948486|NCT00957944|O1|Outcome|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948487|NCT00957944|E2|Reported Event|Treatment B (Reference: PR 2.1.1 AND)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS Andernach, Germany (Reference; drug product PR2.1.1 AND); single application of 1 patch for 24 hours
948488|NCT00957944|E1|Reported Event|Treatment A (Test: PR 2.1.1 WCL)|Rotigotine transdermal patch (4.5 mg/10 cm^2) manufactured at LTS West Caldwell, USA (Test; drug product PR2.1.1 WCL); single application of 1 patch for 24 hours
948489|NCT00957905|B3|Baseline|Total|Total of all reporting groups
948490|NCT00957905|B2|Baseline|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
948491|NCT00957905|B1|Baseline|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
948492|NCT00957905|P2|Participant Flow|Part B|"6 wks: Flavopiridol:70 mg/m2/day IV 1 hr Days 1, 15 & 29. Oxaliplatin:85 mg/m2/day IV 2 hrs Days 1, 15 & 29. Leucovorin:400 mg/m2/day IV 2 hrs Days 1, 15 & 29.~5-FU: 400 mg/m2 IV 15 min, and 1800 mg/m2 IV 48 hrs Days 1-2, 15-16 & 29-30."
948493|NCT00957905|P1|Participant Flow|Part A|6 weeks: Flavopiridol: 70 mg/m2/day IV over 1 hr on days 1, 15 and 29. Oxaliplatin: 85 mg/m2/day IV over 2 hrs on days 1, 15 and 29.
948494|NCT00957905|O2|Outcome|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
948495|NCT00957905|O1|Outcome|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
948496|NCT00957905|E2|Reported Event|Part B (Alvocidib and FOLFOX)|Patients receive alvocidib IV over 1 hour, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 48 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
948497|NCT00957905|E1|Reported Event|Part A (Alvocidib and Oxaliplatin)|Patients receive alvocidib IV over 1 hour and oxaliplatin IV over 2 hours on days 1, 15, and 29. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
948498|NCT00957723|B1|Baseline|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
948499|NCT00957723|P1|Participant Flow|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System can have one or both knees replaced. If both knees were replaced, but only one knee completed the study, the participant is counted as having completed.
948500|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948501|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948502|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948503|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948504|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948505|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948506|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948507|NCT00957723|O1|Outcome|Triathlon® CR Total Knee System|Non-censored participants/knees who received the Triathlon® CR Total Knee System
948508|NCT00957723|E1|Reported Event|Triathlon® CR Total Knee System|Participants who received the Triathlon® CR Total Knee System and were not censored from analysis.
948509|NCT00957684|B5|Baseline|Total|Total of all reporting groups
948510|NCT00957684|B4|Baseline|Placebo|Placebo tablets; once daily administration by oral route
948511|NCT00957684|B3|Baseline|ESL 400 mg|400-mg; once daily administration by oral route
948512|NCT00957684|B2|Baseline|ESL 800 mg|800-mg; once daily administration by oral route
948514|NCT00957684|P5|Participant Flow|ESL - Part II|During Part II of the study all patients received ESL, including those who had been treated with placebo during Part I. The duration of treatment during Part II was one year for all patients completing the study.
948515|NCT00957684|P4|Participant Flow|Placebo|placebo : once daily placebo comparator
948516|NCT00957684|P3|Participant Flow|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
948517|NCT00957684|P2|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
948518|NCT00957684|P1|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
948519|NCT00957684|O4|Outcome|ESL 1200 mg|ESL was supplied in 400-mg and 800-mg tablets; once daily administration by oral route.
948520|NCT00957684|O3|Outcome|ESL 800 mg|ESL was supplied in 800-mg tablets; once daily administration by oral route.
948521|NCT00957684|O2|Outcome|ESL 400 mg|ESL was supplied in 400-mg tablets; once daily administration by oral route.
948522|NCT00957684|O1|Outcome|Placebo|Placebo tablets matching the 400-mg and 800-mg active substance tablets were supplied; once daily administration by oral route.
948523|NCT00957684|E4|Reported Event|Placebo|placebo : once daily placebo comparator
948524|NCT00957684|E3|Reported Event|ESL 800 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
948525|NCT00957684|E2|Reported Event|ESL 400 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
948526|NCT00957684|E1|Reported Event|ESL 1200 mg Once Daily|eslicarbazepine acetate : once-daily oral tablet
948527|NCT00957658|B1|Baseline|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
948528|NCT00957658|P1|Participant Flow|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device. Participants have one or both hips replaced. If both hips were replaced, but only one hip completed the primary endpoint, the participant is counted as completed.
948529|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948530|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948531|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948532|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948533|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948534|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem.
948535|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948536|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948537|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Subjects who received the Accolade® TMZF® Hip Stem
948538|NCT00957658|O1|Outcome|Accolade® TMZF® Hip Stem|Accolade® TMZF® Hip Stem Study Device
948539|NCT00957658|E1|Reported Event|Accolade TMZF Hip Stem|Participants who received the Accolade TMZF Hip Stem
948540|NCT00957593|B3|Baseline|Total|Total of all reporting groups
948541|NCT00957593|B2|Baseline|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
948542|NCT00957593|B1|Baseline|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
948543|NCT00957593|P2|Participant Flow|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
948544|NCT00957593|P1|Participant Flow|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
948545|NCT00957593|O2|Outcome|Oxytocin Discontinuation|Oxytocin will be stopped once the patient reaches active labor
948546|NCT00957593|O1|Outcome|Oxytocin|Continuation of oxytocin per protocol once the patient reaches active labor
948547|NCT00957593|E2|Reported Event|Oxytocin Discontinuation|Oxytocin discontinuation in the active phase of labor
948548|NCT00957593|E1|Reported Event|Oxytocin Arm|no adverse effects noted amongst the 252 patients enrolled in the study 127 in ROUTINE 125 in DISCONTINUATION ARM
948549|NCT00957580|B4|Baseline|Total|Total of all reporting groups
948550|NCT00957580|B3|Baseline|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948551|NCT00957580|B2|Baseline|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948552|NCT00957580|B1|Baseline|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948553|NCT00957580|P3|Participant Flow|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948554|NCT00957580|P2|Participant Flow|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948555|NCT00957580|P1|Participant Flow|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948739|NCT00957372|P2|Participant Flow|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
951339|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
948556|NCT00957580|O2|Outcome|Regimen 2 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948557|NCT00957580|O1|Outcome|Regimen 1 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948558|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948559|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948746|NCT00957372|O2|Outcome|TEAE With Onset Within the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
948876|NCT00957047|O2|Outcome|TEAE With Onset Within the 1st 4 Weeks|
948560|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948561|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948562|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948563|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948564|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948565|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948566|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948567|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948568|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948569|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948570|NCT00957580|O1|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948571|NCT00957580|O8|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948572|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948573|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948574|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948575|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948576|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948577|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948578|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948747|NCT00957372|O1|Outcome|TEAE|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
948877|NCT00957047|O1|Outcome|TEAE|
948579|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948580|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948581|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948582|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948583|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948584|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948585|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948586|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948587|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948588|NCT00957580|O1|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948589|NCT00957580|O8|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948590|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948591|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948592|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948593|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948594|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948740|NCT00957372|P1|Participant Flow|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
948795|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948595|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948596|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948597|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948748|NCT00957372|O3|Outcome|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
948598|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948599|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948600|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948601|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948602|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948603|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948604|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948605|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948606|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948607|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948608|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948609|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948610|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948611|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948612|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948613|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948741|NCT00957372|O7|Outcome|TEAE Leading to Death|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
948855|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948614|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948615|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948654|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
951462|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
948616|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948617|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948618|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948619|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948620|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948621|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948622|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948623|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948624|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948625|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948626|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948627|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948628|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948629|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948630|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948631|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948632|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948633|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948634|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948744|NCT00957372|O4|Outcome|Treatment-related Treatment-emergent Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
948635|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948636|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948637|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948638|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948639|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948640|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948641|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948642|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948643|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948644|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948645|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948646|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948647|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948648|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948649|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948650|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948651|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948652|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948742|NCT00957372|O6|Outcome|Treatment Emergent Serious Adverse Event|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
948653|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948655|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948656|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948657|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948658|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948659|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948660|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948661|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948662|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948663|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948664|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948665|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948666|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948667|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948668|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948669|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948670|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948671|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948672|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948673|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948745|NCT00957372|O3|Outcome|TEAE With Onset After the First 4 Weeks of Part II|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
951463|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
948674|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948675|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948676|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948677|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948678|NCT00957580|O9|Outcome|Pimasertib 90 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 90 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948679|NCT00957580|O8|Outcome|Pimasertib 75 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 75 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948680|NCT00957580|O7|Outcome|Pimasertib 60 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 60 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; on Days 1 to 21 of a 28-day cycle in Regimen 2; and on Days 1-28 of a 28-day cycle in Regimen 3. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948681|NCT00957580|O6|Outcome|Pimasertib 45 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 45 mg twice daily (BID) on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948682|NCT00957580|O5|Outcome|Pimasertib 42 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 42 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948683|NCT00957580|O4|Outcome|Pimasertib 30 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 30 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948684|NCT00957580|O3|Outcome|Pimasertib 23 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 23 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948685|NCT00957580|O2|Outcome|Pimasertib 15 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 15 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948686|NCT00957580|O1|Outcome|Pimasertib 8 mg (All Regimens [Part 1])|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle in Regimen 1; and on Days 1 to 21 of a 28-day cycle in Regimen 2. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948687|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948688|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948689|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948690|NCT00957580|O2|Outcome|Regimen 2 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 21 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948691|NCT00957580|O1|Outcome|Regimen 1 (Part 2)|Pimasertib was to be administered orally twice daily on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. Dose was to be determined by Part 1 of the trial (could be the MTD or lower dose level). The treatment was to be continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948692|NCT00957580|O3|Outcome|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948693|NCT00957580|O2|Outcome|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948694|NCT00957580|O1|Outcome|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948695|NCT00957580|E3|Reported Event|Regimen 3 (Part 1)|Pimasertib was administered orally at a dose of 60 mg BID on Days 1-28 of a 28-day cycle. The dose was escalated to 75 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948696|NCT00957580|E2|Reported Event|Regimen 2 (Part 1)|Pimasertib was administered orally at a dose of 8 mg BID on Days 1 to 21 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 45 mg BID, 60 mg BID, 75 mg BID, and 90 mg BID until MTD was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948697|NCT00957580|E1|Reported Event|Regimen 1 (Part 1)|Pimasertib was administered orally at a dose of 8 mg twice daily (BID) on Days 1 to 5, 8 to 12, 15 to 19, and 22 to 26 of a 28-day cycle. The dose was escalated to 15 mg BID, 23 mg BID, 30 mg BID, 42 mg BID, 60 mg BID, and 75 mg BID) until Maximum Tolerated Dose (MTD) was obtained. The treatment was continued until disease progression, intolerable toxicity, or Investigator/subject decision.
948698|NCT00957528|B4|Baseline|Total|Total of all reporting groups
948699|NCT00957528|B3|Baseline|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948700|NCT00957528|B2|Baseline|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948701|NCT00957528|B1|Baseline|Placebo|Weekly placebo treatment for a duration of 5 months.
948702|NCT00957528|P3|Participant Flow|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948703|NCT00957528|P2|Participant Flow|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948704|NCT00957528|P1|Participant Flow|Placebo|Weekly placebo treatment for a duration of 5 months.
948705|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948706|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948707|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
948708|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948709|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948710|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
948711|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948712|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948713|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
948714|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948715|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948716|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
948717|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948718|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948719|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
948720|NCT00957528|O3|Outcome|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948721|NCT00957528|O2|Outcome|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948722|NCT00957528|O1|Outcome|Placebo|Weekly placebo treatment for a duration of 5 months.
948723|NCT00957528|E3|Reported Event|Continuous Testosterone|Weekly testosterone treatment for a duration of 5 months
948724|NCT00957528|E2|Reported Event|Monthly Cycled Testosterone|A month of weekly testosterone treatment alternated by a month of weekly placebo treatment for a duration of 5 months.
948725|NCT00957528|E1|Reported Event|Placebo|Weekly placebo treatment for a duration of 5 months.
948726|NCT00957424|B1|Baseline|Overall|Single-armed study
948727|NCT00957424|P1|Participant Flow|Noncombusted Nicotine Product With Informational Intervention|Single-armed study
948728|NCT00957424|O1|Outcome|Overall|Single-armed study
948729|NCT00957424|O1|Outcome|Overall|Single-armed study
948730|NCT00957424|O1|Outcome|Overall|Single-armed study
948731|NCT00957424|O1|Outcome|Overall|Single-armed study
948732|NCT00957424|E1|Reported Event|Overall|Single-armed study
948733|NCT00957372|B4|Baseline|Total|Total of all reporting groups
948734|NCT00957372|B3|Baseline|Placebo|"placebo~placebo : once daily placebo comparator"
948735|NCT00957372|B2|Baseline|ESL 800mg Daily|"ESL 800mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
948736|NCT00957372|B1|Baseline|ESL 1200mg Daily|"ESL 1200mg daily~eslicarbazepine acetate : oral tablet, 800 mg or 1200 mg once daily"
948737|NCT00957372|P4|Participant Flow|Open-label Extension (Part II)|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
948738|NCT00957372|P3|Participant Flow|Placebo|"placebo~placebo : once daily placebo comparator"
948856|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948743|NCT00957372|O5|Outcome|TEAE Leading to Discontinuation From the Study|Starting at 800 mg/day, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg/day or up to a maximum of 1200 mg/day.
948749|NCT00957372|O2|Outcome|ESL 800 mg|400 mg active substance tablets were supplied
951464|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
948750|NCT00957372|O1|Outcome|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied.
948751|NCT00957372|E4|Reported Event|Open-label Extension (Part II)|ESL dose taken; Starting at 800 mg once daily, the dosage could be titrated at 400 mg intervals down to a minimum of 400 mg once daily or up to a maximum of 1200 mg once daily.
948752|NCT00957372|E3|Reported Event|ESL 1200 mg|400 and 600 mg active substance tablets were supplied
948753|NCT00957372|E2|Reported Event|ESL 800 mg|400 mg active substance tablets were supplied
948754|NCT00957372|E1|Reported Event|Placebo|Placebo tablets matching the 400 and 600 mg active substance tablets were supplied
948755|NCT00957333|B1|Baseline|Case|"ketamine + Cystitis~ketamine"
948756|NCT00957333|P1|Participant Flow|Case|"ketamine + Cystitis~ketamine"
948757|NCT00957333|O1|Outcome|Case|"ketamine + Cystitis~ketamine"
948758|NCT00957333|E1|Reported Event|Case|"ketamine + Cystitis~ketamine"
948759|NCT00957268|B6|Baseline|Total|Total of all reporting groups
948760|NCT00957268|B5|Baseline|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948761|NCT00957268|B4|Baseline|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948762|NCT00957268|B3|Baseline|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948763|NCT00957268|B2|Baseline|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948764|NCT00957268|B1|Baseline|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948765|NCT00957268|P5|Participant Flow|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948766|NCT00957268|P4|Participant Flow|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948767|NCT00957268|P3|Participant Flow|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948768|NCT00957268|P2|Participant Flow|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948769|NCT00957268|P1|Participant Flow|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948770|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948771|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948772|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948773|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948774|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948775|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948776|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948777|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948778|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948779|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948780|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948781|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948782|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948783|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948784|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948785|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948786|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948787|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948788|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948789|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948790|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948791|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948792|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948793|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948794|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948796|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948797|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948798|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948799|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948800|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948801|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948802|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948803|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948804|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948805|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948806|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948807|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948808|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948809|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948810|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948811|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948812|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948813|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948814|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948815|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948816|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948817|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948818|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948819|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948820|NCT00957268|O5|Outcome|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948821|NCT00957268|O4|Outcome|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948822|NCT00957268|O3|Outcome|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948823|NCT00957268|O2|Outcome|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948824|NCT00957268|O1|Outcome|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948825|NCT00957268|E5|Reported Event|Alogliptin 25 mg (Age 18 to 65 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948826|NCT00957268|E4|Reported Event|Alogliptin 25 mg (Age 14 to < 18 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948827|NCT00957268|E3|Reported Event|Alogliptin 12.5 mg (Age 14 to < 18 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948828|NCT00957268|E2|Reported Event|Alogliptin 25 mg (Age 10 to < 14 Years)|Alogliptin 25 mg QD, tablets, orally, 1 dose only.
948829|NCT00957268|E1|Reported Event|Alogliptin 12.5 mg (Age 10 to < 14 Years)|Alogliptin 12.5 mg QD, tablets, orally, 1 dose only.
948830|NCT00957242|B3|Baseline|Total|Total of all reporting groups
948831|NCT00957242|B2|Baseline|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
948832|NCT00957242|B1|Baseline|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
948833|NCT00957242|P2|Participant Flow|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
948834|NCT00957242|P1|Participant Flow|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
948835|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948836|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948837|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948838|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948839|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948840|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948841|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948842|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948843|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948844|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948845|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948846|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948847|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948848|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948849|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948850|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948851|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948852|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
948853|NCT00957242|O2|Outcome|Warfarin|Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3.
948854|NCT00957242|O1|Outcome|Placebo|Oral placebo (1mg or 2.5mg)
951340|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
948857|NCT00957242|O2|Outcome|Warfarin|warfarin sodium titrated to an INR of 2.0-3.0
948858|NCT00957242|O1|Outcome|Placebo|matched placebo
948859|NCT00957242|E2|Reported Event|Warfarin|"Oral warfarin titrated to an INR of 2-3~warfarin : Oral warfarin (1mg or 2.5mg) titrated to an INR of 2-3."
948860|NCT00957242|E1|Reported Event|Placebo|"Oral placebo (1mg or 2.5mg)~placebo : Oral placebo (1mg or 2.5mg)"
948861|NCT00957047|B5|Baseline|Total|Total of all reporting groups
948862|NCT00957047|B4|Baseline|Placebo|placebo : once daily placebo comparator
948863|NCT00957047|B3|Baseline|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
948864|NCT00957047|B2|Baseline|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
948865|NCT00957047|B1|Baseline|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
948866|NCT00957047|P5|Participant Flow|ESL - Part II|All patients in Part II received ESL on an open-label basis, starting at 800 mg once daily.
948867|NCT00957047|P4|Participant Flow|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
948868|NCT00957047|P3|Participant Flow|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
948878|NCT00957047|O4|Outcome|Placebo|placebo : once daily placebo comparator
948879|NCT00957047|O3|Outcome|ESL 800 mg Once Daily|eslicarbazepine acetate : oral tablets
948880|NCT00957047|O2|Outcome|ESL 400 mg Once Daily|eslicarbazepine acetate : oral tablets
948881|NCT00957047|O1|Outcome|ESL 1200 mg Once Daily|eslicarbazepine acetate : oral tablets
948882|NCT00957047|E5|Reported Event|ESL PART II|All patients in Part II received ESL
948883|NCT00957047|E4|Reported Event|ESL 1200 mg|Tablets; oral route
948884|NCT00957047|E3|Reported Event|ESL 800 mg|Tablets; oral route
948885|NCT00957047|E2|Reported Event|ESL 400 mg|Tablets; oral route
948886|NCT00957047|E1|Reported Event|Placebo|Tablets; oral route
948887|NCT00957034|B4|Baseline|Total|Total of all reporting groups
948888|NCT00957034|B3|Baseline|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948889|NCT00957034|B2|Baseline|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948890|NCT00957034|B1|Baseline|Placebo|placebo patch
948891|NCT00957034|P3|Participant Flow|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948892|NCT00957034|P2|Participant Flow|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948893|NCT00957034|P1|Participant Flow|Placebo|placebo patch
948894|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948895|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948896|NCT00957034|O1|Outcome|Placebo|placebo patch
948897|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948898|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948899|NCT00957034|O1|Outcome|Placebo|placebo patch
948900|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948901|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948902|NCT00957034|O1|Outcome|Placebo|placebo patch
948903|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948904|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948905|NCT00957034|O1|Outcome|Placebo|placebo patch
948906|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948907|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948908|NCT00957034|O1|Outcome|Placebo|placebo patch
948909|NCT00957034|O3|Outcome|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948910|NCT00957034|O2|Outcome|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948911|NCT00957034|O1|Outcome|Placebo|placebo patch
948912|NCT00957034|E3|Reported Event|450 µg/Day Testosterone|450 micrograms/day transdermal testosterone patch
948913|NCT00957034|E2|Reported Event|300 µg/Day Testosterone|300 micrograms/day transdermal testosterone patch
948914|NCT00957034|E1|Reported Event|Placebo|placebo patch
948915|NCT00957021|B1|Baseline|Triathlon® PS Total Knee System|Participants who were not censored from analysis.
948916|NCT00957021|P1|Participant Flow|Triathlon® PS Total Knee System|If both knees were replaced, but only one knee completed the study, the participant is counted as completed.
948917|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
948918|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
948919|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
948920|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
948921|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes non-censored participants/knees who received the Triathlon PS Total Knee System. Secondary Objectives are reported by knee.
948922|NCT00957021|O1|Outcome|Triathlon® PS Total Knee System|Includes participants who received the Triathlon® PS Total Knee System. Participants may have bilateral Triathlon® PS Total Knee replacement (TKR), with surgery occurring on different dates. Participants can therefore have a different status for each knee. If one knee has completed the study (i.e. has 2 year ROM data), the participant is counted in the study complete category.
948923|NCT00957021|E1|Reported Event|Triathlon® PS Total Knee System|All non-censored participants who received the Triathlon® PS Total Knee System.
948924|NCT00957008|B5|Baseline|Total|Total of all reporting groups
948925|NCT00957008|B4|Baseline|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
948926|NCT00957008|B3|Baseline|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
948927|NCT00957008|B2|Baseline|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
950867|NCT00950937|P2|Participant Flow|Control Group|Non HIV-infected persons
948928|NCT00957008|B1|Baseline|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
948929|NCT00957008|P4|Participant Flow|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
948930|NCT00957008|P3|Participant Flow|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
948931|NCT00957008|P2|Participant Flow|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
948932|NCT00957008|P1|Participant Flow|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
948933|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
948934|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
948935|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
948936|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
948937|NCT00957008|O4|Outcome|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
948974|NCT00956813|B1|Baseline|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948975|NCT00956813|P2|Participant Flow|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
949330|NCT00955110|O3|Outcome|Oxymorphone ER 30 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 30 mg.
948938|NCT00957008|O3|Outcome|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
948939|NCT00957008|O2|Outcome|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
948940|NCT00957008|O1|Outcome|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
948941|NCT00957008|E4|Reported Event|Standard Care (Control Group)|Standard care participants received a self-directed weight loss manual based on two evidence-based programs, Active Living Every Day (ALED) and Healthy Eating Every Day (HEED). The manual’s focus was to help individuals adopt a healthful eating pattern and increase their physical activity levels through the use of cognitive and behavioral strategies consistent with the Transtheoretical Model and Social Cognitive Theory.
949302|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
948942|NCT00957008|E3|Reported Event|Armband Alone Group (SWA-alone)|The SWA-alone group received the SenseWearTM platform consisting of the armband, a real-time wrist watch display, and access to a personalized Weight Management Solutions web account. While wearing the armband, participants received real-time feedback from the wrist watch on several outcomes (i.e. energy expenditure, minutes spent in moderate and vigorous physical activity, and steps per day). Feedback regarding energy balance was received as participants regularly uploaded their armband to the website and recorded daily energy intake and body weight to the Weight Management Solutions web account. Participants were asked to wear the armband 16 hours a day, 7 days a week.
948943|NCT00957008|E2|Reported Event|Combined GWL and SWA Group (GWL+SWA)|These participants received all components of the GWL including the 6 one-on-one telephone counseling sessions and also received the SenseWearTM platform.
948944|NCT00957008|E1|Reported Event|Group-based Behavioral Weight Loss Education Group (GWL)|During the first 4 months of the intervention, these participants received 14 GWL sessions based on ALED and HEED. Each session followed the ALED and HEED curriculum format with the addition of a weekly weigh-in and greater emphasis on weight loss than in the original programs. During the final 5 months participants received 6 one-on-one telephone counseling sessions to provide continued support and enhance weight loss maintenance.
948945|NCT00956943|B3|Baseline|Total|Total of all reporting groups
948946|NCT00956943|B2|Baseline|42mg Transdermal Nicotine|
948947|NCT00956943|B1|Baseline|21mg Transdermal Nicotine + Placebo Patch|
948948|NCT00956943|P2|Participant Flow|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
948949|NCT00956943|P1|Participant Flow|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
948950|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
948951|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
948952|NCT00956943|O2|Outcome|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
948953|NCT00956943|O1|Outcome|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
948954|NCT00956943|E2|Reported Event|42mg Transdermal Nicotine|"42mg transdermal nicotine~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks"
948955|NCT00956943|E1|Reported Event|21mg Transdermal Nicotine + Placebo Patch|"21mg transdermal nicotine + placebo patch~Nicoderm CQ transdermal nicotine : Transdermal nicotine patch (21mg vs. 42mg), 8 weeks~placebo : placebo patch"
948956|NCT00956839|B4|Baseline|Total|Total of all reporting groups
948957|NCT00956839|B3|Baseline|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
948958|NCT00956839|B2|Baseline|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
948959|NCT00956839|B1|Baseline|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
948960|NCT00956839|P3|Participant Flow|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
948961|NCT00956839|P2|Participant Flow|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
948962|NCT00956839|P1|Participant Flow|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
948963|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
948964|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
948965|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
948966|NCT00956839|O3|Outcome|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
948967|NCT00956839|O2|Outcome|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
948968|NCT00956839|O1|Outcome|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
948969|NCT00956839|E3|Reported Event|Oral Vitamin D3|Oral vitamin D3 500 Units/ day
948970|NCT00956839|E2|Reported Event|IM Vitamin D3 6,00,000 Units|IM vitamin D3 6,00,000 Units single dose
948971|NCT00956839|E1|Reported Event|IM Vitamin D3 3,00,000 Units|IM Vitamin D3 3,00,000 Units single dose
948972|NCT00956813|B3|Baseline|Total|Total of all reporting groups
948973|NCT00956813|B2|Baseline|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
948976|NCT00956813|P1|Participant Flow|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948977|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
948978|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948979|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
948980|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948981|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
948982|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948983|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
948984|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948985|NCT00956813|O2|Outcome|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
948986|NCT00956813|O1|Outcome|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
949348|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
948987|NCT00956813|E3|Reported Event|Optional Continuation Period|After completing the Placebo/Flaxseed double-blind period, patients were allowed to continue with 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948988|NCT00956813|E2|Reported Event|Placebo|Patients Identical looking bar with same calorie and total fat content but without flaxseed or lignans once daily.
948989|NCT00956813|E1|Reported Event|Flaxseed|Patients receive 1 Nutrigrad™ flaxseed bar containing 7.5 grams flaxseed, 410 mg lignans,once daily.
948990|NCT00956761|B1|Baseline|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
948991|NCT00956761|P1|Participant Flow|FLUAD|Participants received a single intramuscular (IM) 0.5 milliliter (mL) dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
948992|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 3.
948993|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
948994|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
948995|NCT00956761|O1|Outcome|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
948996|NCT00956761|E1|Reported Event|FLUAD|Participants received a single IM 0.5 mL dose of FLUAD, a trivalent subunit inactivated adjuvanted with MF59C.1 influenza vaccine recommended for the NH 2009/2010 influenza season, into the deltoid region of the non-dominant arm on Day 0 and were assessed until Day 21.
948997|NCT00956709|B3|Baseline|Total|Total of all reporting groups
948998|NCT00956709|B2|Baseline|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
948999|NCT00956709|B1|Baseline|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
949000|NCT00956709|P2|Participant Flow|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
949001|NCT00956709|P1|Participant Flow|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
949002|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
949003|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
949004|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
949005|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
949006|NCT00956709|O2|Outcome|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
949007|NCT00956709|O1|Outcome|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
949008|NCT00956709|E2|Reported Event|Ropivacaïne 0,5%|ropivacaïne 0,5 %: 20mL de ropivacaïne 0,5 %
949009|NCT00956709|E1|Reported Event|Levobupivacaïne 0,5 %|levobupivacaïne 0,5 %: 20mL de levobupivacaïne 0,5 % 20mL de ropivacaïne 0,5 %
949010|NCT00956657|B3|Baseline|Total|Total of all reporting groups
949011|NCT00956657|B2|Baseline|Treatment As Usual|Control group. Treatment received as usual.
949012|NCT00956657|B1|Baseline|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
949013|NCT00956657|P2|Participant Flow|Treatment As Usual|Control group. Treatment received as usual.
949014|NCT00956657|P1|Participant Flow|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
949015|NCT00956657|O2|Outcome|Treatment As Usual|Control group. Treatment received as usual.
949181|NCT00955513|O2|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
949182|NCT00955513|O1|Outcome|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
949016|NCT00956657|O1|Outcome|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
949017|NCT00956657|E2|Reported Event|Treatment As Usual|Control group. Treatment received as usual.
949018|NCT00956657|E1|Reported Event|Treatment Group|Single treatment session provided by study PI. Session aimed to change participant illness beliefs using motivational interviewing techniques in order to improve adherence to cardiac rehabilitation classes.
949019|NCT00956631|B1|Baseline|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
949020|NCT00956631|P1|Participant Flow|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
949021|NCT00956631|O1|Outcome|Mild Procedure|Symptomatic lumbar spinal stenosis (LSS) patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated using the mild® device kit in a percutaneous lumbar decompression procedure.
949022|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous lumbar decompression with the mild device kit.
949023|NCT00956631|O1|Outcome|Mild Procedure|Percutaneous decompression with the mild device kit.
949024|NCT00956631|E1|Reported Event|Mild Procedure|Symptomatic LSS patients having neurogenic claudication complaints and predominant causal factor of hypertrophic ligamentum flavum were treated with the mild® device kit in a percutaneous decompression procedure.
949025|NCT00956592|B3|Baseline|Total|Total of all reporting groups
949026|NCT00956592|B2|Baseline|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
949027|NCT00956592|B1|Baseline|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
949028|NCT00956592|P2|Participant Flow|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
949029|NCT00956592|P1|Participant Flow|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
949030|NCT00956592|O2|Outcome|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
949031|NCT00956592|O1|Outcome|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
949032|NCT00956592|E2|Reported Event|Macintosh Blade|Patients will have their first intubation attempted utilizing the conventional Macintosh design laryngoscope blade. Success is measured as confirmed tube placement with a single blade insertion
949033|NCT00956592|E1|Reported Event|CMAC Video Laryngoscope|Subjects will have their intubation attempted first with the CMAC video laryngoscope. Success is measured as confirmed tube placement with single blade insertion
949034|NCT00956540|B5|Baseline|Total|Total of all reporting groups
949035|NCT00956540|B4|Baseline|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
949036|NCT00956540|B3|Baseline|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
949037|NCT00956540|B2|Baseline|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
949038|NCT00956540|B1|Baseline|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
949039|NCT00956540|P4|Participant Flow|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
949040|NCT00956540|P3|Participant Flow|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
949041|NCT00956540|P2|Participant Flow|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
949042|NCT00956540|P1|Participant Flow|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
949043|NCT00956540|O4|Outcome|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
949044|NCT00956540|O3|Outcome|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
949045|NCT00956540|O2|Outcome|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
949046|NCT00956540|O1|Outcome|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
949047|NCT00956540|E4|Reported Event|Not Deflating 2|The tracheal cuff remains inflated during the weaning period until the patient is definitively liberated from mechanical ventilation in patients tracheostomized for low level of consciousness or inability to adequate manage the airway.
949048|NCT00956540|E3|Reported Event|Deflating 2|The tracheal cuff is deflated during disconnections from mechanical ventilation periods in patients tracheostomized for low level of consciousness or inability to adequate mange the airway. The cuff is reinflated when the patients is connected to mechanical ventilation.
949049|NCT00956540|E2|Reported Event|Not Deflating|The tracheal cuff remains inflated during disconnections from mechanical ventilation periods until the patients is definitively liberated from mechanical ventilation in patients tracheostomized for prolonged weaning or ventilatory support
949050|NCT00956540|E1|Reported Event|Deflating|The tracheal cuff is deflating during disconnection from mechanical ventilation periods in patients tracheostomized for prolonged weaning or ventilatory support. While patients are connected to mechanical ventilation, the cuff is reinflated.
949051|NCT00956293|B3|Baseline|Total|Total of all reporting groups
949349|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received Sham tx.
949052|NCT00956293|B2|Baseline|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949053|NCT00956293|B1|Baseline|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949054|NCT00956293|P3|Participant Flow|Pre-randomized Group|Participants, who met BL1 eligibility, were enrolled into the study.
949055|NCT00956293|P2|Participant Flow|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949056|NCT00956293|P1|Participant Flow|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949057|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949058|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949059|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949060|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949061|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949062|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949063|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949064|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949065|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949066|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949067|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949068|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949183|NCT00955513|E3|Reported Event|Placebo. Applied 3 Times a Day.|placebo
949069|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949070|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949071|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949072|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949350|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
950868|NCT00950937|P1|Participant Flow|HIV Group|HIV infected persons
949073|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949074|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949075|NCT00956293|O2|Outcome|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949076|NCT00956293|O1|Outcome|Control Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949077|NCT00956293|E2|Reported Event|Everolimus Group|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group made a stepwise switch to a CNI-free regimen of everolimus and MPA.
949078|NCT00956293|E1|Reported Event|Control Goup|During the pre-randomized treatment phase, all participants received a CNI-based regimen consisting of basiliximab, mycophenolic acid (MPA), cyclosporin A (CsA) and corticosteroids (optional). Upon randomization, participants in this group continued with a CNI-based regimen of MPA and CsA.
949079|NCT00956254|B1|Baseline|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949080|NCT00956254|P1|Participant Flow|Fentanyl Sublingual Spray 100 µg|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949081|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949082|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949083|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949084|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949085|NCT00956254|O2|Outcome|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949086|NCT00956254|O1|Outcome|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949087|NCT00956254|E2|Reported Event|Fentanyl Sublingual Spray 100 µg - Non-mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949088|NCT00956254|E1|Reported Event|Fentanyl Sublingual Spray 100 µg - Mucositis|Participants received a single administration of fentanyl sublingual spray 100 µg sublingually.
949093|NCT00956020|B1|Baseline|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949184|NCT00955513|E2|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
949185|NCT00955513|E1|Reported Event|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
949094|NCT00956020|P1|Participant Flow|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949095|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949096|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949097|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949098|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949099|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949100|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 30 minutes after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949101|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949102|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 10 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949103|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 6 weeks after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
949104|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 2 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949351|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
949105|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies 1 week after treatment.~Platelet rich fibrin matrix: Single treatment with platelet rich fibrin matrix"
949106|NCT00956020|O1|Outcome|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a period from 30 minutes to 12 weeks after treatment.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949107|NCT00956020|E1|Reported Event|Treatment|"Skin injection with platelet rich fibrin matrix on the inner aspect of the upper arm, with biopsies over a 12 week period.~Platelet rich fibrin matrix : Single treatment with platelet rich fibrin matrix"
949108|NCT00955955|B4|Baseline|Total|Total of all reporting groups
949109|NCT00955955|B3|Baseline|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
949110|NCT00955955|B2|Baseline|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
949111|NCT00955955|B1|Baseline|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
949112|NCT00955955|P3|Participant Flow|Placebo/Placebo|Both tablets of study medication will be placebo during both phases of the study.
949113|NCT00955955|P2|Participant Flow|Placebo/Deplin|Participants will receive placebo for the first 4 weeks, and then 15 mg/day of Deplin (6(S)-5-MTHF) for the next 4 weeks.
949114|NCT00955955|P1|Participant Flow|Deplin/Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 8 weeks.
949115|NCT00955955|O4|Outcome|Adjunct Placebo Phase II|Patients received placebo for the second 4 weeks of the study. Patients who received placebo in phase 2 also received it in phase 1.
949116|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase II|Patients received Deplin for 4 weeks.
949117|NCT00955955|O2|Outcome|Adjunct Placebo Phase I|Patients who received placebo for 4 weeks.
949118|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase I|Patients who received Deplin (L-methylfolate) for 4 weeks
949119|NCT00955955|O6|Outcome|Pooled Placebo|Patients in this group received placebo at some point during the study. Results are pooled from phase I and II.
949120|NCT00955955|O5|Outcome|Pooled Deplin|Patients in this group received Deplin at some point during the study. Results are pooled from phase I and II.
949121|NCT00955955|O4|Outcome|Adjunct Placebo Phase 2|Patients in this group received placebo in both phases of the study for a total of 8 weeks,
949122|NCT00955955|O3|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 2|Participants will receive 15 mg of Deplin (6(S)-5-MTHF) for 4 weeks.
949123|NCT00955955|O2|Outcome|Adjunct Placebo Phase 1|Participants will receive placebo for the first 4 weeks
949124|NCT00955955|O1|Outcome|Adjunct 6(S)-5-MTHF(Deplin) Phase 1|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF) for 4 weeks.
949125|NCT00955955|E2|Reported Event|Placebo|Adverse events for participants who received placebo during the study.
949126|NCT00955955|E1|Reported Event|Deplin|Participants will receive 15 mg/day of Deplin (6(S)-5-MTHF).
949127|NCT00955916|B1|Baseline|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
949186|NCT00955487|B3|Baseline|Total|Total of all reporting groups
949287|NCT00955279|B1|Baseline|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
951341|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
949128|NCT00955916|P1|Participant Flow|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
949129|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
949130|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
949131|NCT00955916|O1|Outcome|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
949132|NCT00955916|E1|Reported Event|CLAG Regimen With Gleevec®|"Combined chemotherapy treatment (CLAG regimen) with Gleevec® (imatinib mesylate).~Gleevec®: Imatinib mesylate 400 mg orally twice daily was administered on day 2 to day 15. Re-induction was allowed if participant had partial response (PR).~CLAG Regimen: The CLAG regimen consisted of: Cladribine, 5 mg/m^2 administered via 2 hour IV daily for 5 consecutive days starting on day 2; Cytarabine, 2 mg/m^2 administered through a 4 hour IV starting 2 hours after the ignition of Cladribine for 5 days starting on day 2; granulocyte colony-stimulating factor (G-CSF): 300 mcg subcutaneous (SC) for 6 days starting 12-24 hours (Day 1) before the first dose of Cladribine."
949133|NCT00955825|B3|Baseline|Total|Total of all reporting groups
949134|NCT00955825|B2|Baseline|Placebo|Placebo tablet
949135|NCT00955825|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
949136|NCT00955825|P2|Participant Flow|Placebo|Placebo tablet
949137|NCT00955825|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
949138|NCT00955825|O2|Outcome|Placebo|Placebo tablet
949139|NCT00955825|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
949140|NCT00955825|E2|Reported Event|Placebo|Placebo tablet
949141|NCT00955825|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
949142|NCT00955747|B3|Baseline|Total|Total of all reporting groups
949143|NCT00955747|B2|Baseline|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
949144|NCT00955747|B1|Baseline|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
949145|NCT00955747|P2|Participant Flow|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
949146|NCT00955747|P1|Participant Flow|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
949147|NCT00955747|O2|Outcome|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
949148|NCT00955747|O1|Outcome|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
949149|NCT00955747|E2|Reported Event|Tagatose|15 g Tagatose dissolved in 125 ml of water three times a day. The Tagatose dosage will be decreased to 10 g dissolved in 125 ml of water tid or decreased additionally to 5 g Tagatose dissolved in 125 ml of water tid, if needed due to gastrointestinal effects, until patients adapt to the treatment
949150|NCT00955747|E1|Reported Event|Sugar Substitute Splenda|1.5 g Sugar Substitute Splenda, dissolved in 125 ml of water three times per day. If intestinal problems occur, the dose should be reduced to 1 g dissolved in water tid or additionally reduced to 0.5 g dissolved in 125 ml of water tid if problems still persisted, until patients adapted to treatment.
949151|NCT00955721|B3|Baseline|Total|Total of all reporting groups
949331|NCT00955110|O2|Outcome|Oxymorphone ER 15 mg|Subjects received a single oral dose (1 capsule) of Oxymorphone ER 15 mg.
949152|NCT00955721|B2|Baseline|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949153|NCT00955721|B1|Baseline|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949154|NCT00955721|P2|Participant Flow|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949155|NCT00955721|P1|Participant Flow|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949156|NCT00955721|O2|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949352|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
949157|NCT00955721|O1|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949158|NCT00955721|O2|Outcome|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949159|NCT00955721|O1|Outcome|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949160|NCT00955721|E2|Reported Event|Phase 2: RPTD GEMOX + Sorafenib|"Recommended Phase Two Dose (RPTD) of Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: Recommended Phase II Dose determined from Phase I, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: Recommended Phase II Dose determined from Phase I, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: Recommended Phase II Dose determined from Phase I, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949161|NCT00955721|E1|Reported Event|Phase 1: GEMOX + Sorafenib|"Gemcitabine and Oxaliplatin (GEMOX) and Sorafenib:~Gemcitabine: 1000 or 750 mg/m2, IV, Day 1 of each 14 day cycle, until progression or unacceptable toxicity develops.~Oxaliplatin: 100 or 75 mg/m2, IV, Day 2 of each 14 day cycle, until progression or unacceptable toxicity develops.~Sorafenib: 200 mg, Orally, twice daily for each 14-day cycle, until progression or unacceptable toxicity develops."
949162|NCT00955617|B1|Baseline|All Patients|All Patients received both product Dotarem and Gadovist during 2 enhanced-MRA. Demographic analysis was performed on the global population.
949163|NCT00955617|P2|Participant Flow|Gadovist Then Dotarem|Cross over administration: patient received first Gadovist enhanced-MRA (MRA1) and then Dotarem enhanced-MRA (MRA2)
949164|NCT00955617|P1|Participant Flow|Dotarem Then Gadovist|Cross over administration, patient received first Dotarem enhanced-MRA (MRA1) and then Gadovist enhanced-MRA (MRA2)
949165|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
949166|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
949167|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
949168|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
949169|NCT00955617|O2|Outcome|Gadovist|Evaluation performed on Gadovist enhanced MRA images
949170|NCT00955617|O1|Outcome|Dotarem|Evaluation performed on Dotarem enhanced MRA images
949171|NCT00955617|E2|Reported Event|Gadovist MRA|Patients who received a Gadovist enhanced-MRA
949172|NCT00955617|E1|Reported Event|Dotarem MRA|Patients who received a Dotarem enhanced-MRA
949173|NCT00955513|B4|Baseline|Total|Total of all reporting groups
949174|NCT00955513|B3|Baseline|Placebo. Applied 3 Times a Day.|placebo
949175|NCT00955513|B2|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
949176|NCT00955513|B1|Baseline|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
949177|NCT00955513|P3|Participant Flow|Placebo. Applied 3 Times a Day.|placebo
949178|NCT00955513|P2|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 3 Times a Day|drug
949179|NCT00955513|P1|Participant Flow|Diclofenac Diethylamine Gel 2.32% Gel. Applied 2 Times a Day|drug
949180|NCT00955513|O3|Outcome|Placebo. Applied 3 Times a Day.|placebo
949187|NCT00955487|B2|Baseline|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949188|NCT00955487|B1|Baseline|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949189|NCT00955487|P6|Participant Flow|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949190|NCT00955487|P5|Participant Flow|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949191|NCT00955487|P4|Participant Flow|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949192|NCT00955487|P3|Participant Flow|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949193|NCT00955487|P2|Participant Flow|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949297|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949194|NCT00955487|P1|Participant Flow|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949195|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949196|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949197|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949198|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949199|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949200|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949201|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949202|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949203|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949204|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949205|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949206|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949207|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949332|NCT00955110|O1|Outcome|Placebo|Subjects received a single oral dose (1 capsule) of placebo.
951342|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
949208|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949209|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949210|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949211|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949212|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949213|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949298|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
949353|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed prior to receiving Sham treatment.
949214|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949215|NCT00955487|O6|Outcome|1000-1250g Placebo (Nitrogen)|"Participants weighing between 1000 and 1250 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949216|NCT00955487|O5|Outcome|1000-1250g Inhaled Nitric Oxide (iNO)|"Participants weighing between 1000 and 1250 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949217|NCT00955487|O4|Outcome|750-999g Placebo (Nitrogen)|"Participants weighing between 750 and 999 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949218|NCT00955487|O3|Outcome|750-999g Inhaled Nitric Oxide (iNO)|"Participants weighing between 750-999 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949219|NCT00955487|O2|Outcome|500-749g Placebo (Nitrogen)|"Participants weighing between 500 and 749 grams received Placebo (Nitrogen) until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949220|NCT00955487|O1|Outcome|500-749g Inhaled Nitric Oxide (iNO)|"Participants weighing between 500 and 749 grams received a low concentration of iNO until they were 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~iNO was initiated at 10ppm to yield a minimum of 5ppm to the posterior pharynx."
949221|NCT00955487|O2|Outcome|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949222|NCT00955487|O1|Outcome|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949223|NCT00955487|E2|Reported Event|Placebo (Nitrogen)|"Participants will receive Placebo until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Placebo will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949224|NCT00955487|E1|Reported Event|Inhaled Nitric Oxide (iNO)|"Participants will receive a low concentration of iNO until they are 30 weeks corrected gestational age or for 14 days if they were born at 29 weeks or more.~Inhaled Nitric Oxide (iNO) will be delivered using the iNOVent device to provide 10 ppm proximally (yielding approximately 5 ppm to the posterior pharynx)."
949225|NCT00955474|B3|Baseline|Total|Total of all reporting groups
949226|NCT00955474|B2|Baseline|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949227|NCT00955474|B1|Baseline|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949228|NCT00955474|P2|Participant Flow|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949229|NCT00955474|P1|Participant Flow|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949299|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
949300|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949354|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group received were assessed prior to receiving rTMS treatment.
949230|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949231|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949232|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949233|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949234|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949235|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949236|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949288|NCT00955279|P3|Participant Flow|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949289|NCT00955279|P2|Participant Flow|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
949237|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949238|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949239|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949240|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949241|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949242|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949243|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949244|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949245|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949255|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949290|NCT00955279|P1|Participant Flow|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
949246|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949247|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949248|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949249|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949250|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949251|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949252|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949253|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949254|NCT00955474|O2|Outcome|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949283|NCT00955305|E1|Reported Event|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
949284|NCT00955279|B4|Baseline|Total|Total of all reporting groups
949256|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949257|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949258|NCT00955474|O2|Outcome|Quetiapine With SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949259|NCT00955474|O1|Outcome|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949260|NCT00955474|E2|Reported Event|Quetiapine and SSRI|"Patients assigned to receive Quetiapine and SSRI~Quetiapine XR 100 mg/h.s. starting dose; increased by 100 mg q h.s. q day; target dose 300 mg/h.s. by day 3; continued on 300 mg/h.s. through week 3. Weeks 4-8: flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s.~Sertraline 50 mg/a.m. starting dose; increased to 100 mg/a.m. at week 2; continued on 100 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 200 mg/a.m. or reductions in doses to no lower than 50 mg/a.m.~Citalopram 20 mg/a.m. starting dose; increased to a target dose of 40 mg/a.m. at week 2; continued on 40 mg/a.m. through Week 8: reductions in doses to no lower than 20 mg/a.m.~Escitalopram 5 mg/a.m. starting dose; increase to 10 mg/a.m. at week 2 and continued at 10 mg/a.m. through week 3. Weeks 4-8: flexible dosing up to 20 mg/a.m. or reductions in doses to no lower than 5 mg/a.m."
949261|NCT00955474|E1|Reported Event|Quetiapine|"Patients assigned to receive Quetiapine~•Quetiapine XR 100 mg/h.s. will be the starting dose and increased by 100 mg q h.s. q day to a target dose of 300 mg/h.s. by day three and continued on 300 mg/h.s. through week three. Between weeks four and eight, there will be flexible dosing up to 800 mg/h.s. or reductions in doses to no lower than 200 mg/h.s. Incremental increases or decreases in dose will be no more than 100 mg/h.s. over a minimum of one week, unless a patient is unable to tolerate the current dose. Patients unable to tolerate at least 200 mg/h.s. will be discontinued from the study."
949262|NCT00955357|B3|Baseline|Total|Total of all reporting groups
949263|NCT00955357|B2|Baseline|Later-Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949264|NCT00955357|B1|Baseline|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949265|NCT00955357|P2|Participant Flow|Later Add-on|"Lacosamide added to 1 to 3 Anti-Epileptic Drugs (AEDs) (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949266|NCT00955357|P1|Participant Flow|First Add-on|"Lacosamide added to first adequate monotherapy (no history of Anti-Epileptic Drug [AED] polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949285|NCT00955279|B3|Baseline|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949267|NCT00955357|O2|Outcome|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949268|NCT00955357|O1|Outcome|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks): Week 1 - 50 mg tablet twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks): 200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks): 50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949301|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
950869|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
949269|NCT00955357|E2|Reported Event|Later Add-on|"Lacosamide added to 1 to 3 AEDs (with tentatives of at least 2 prior AED treatment regimens) and epilepsy diagnosis > or = 5 years at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949270|NCT00955357|E1|Reported Event|First Add-on|"Lacosamide added to first adequate monotherapy (no history of AED polytherapy) and epilepsy diagnosis < or = 24 months at Screening.~Lacosamide: oral tablet~Subjects Titration Phase (6 Weeks):~Week 1 - 50 mg tablet Twice daily (bid); Week 2 - 100 mg tablet bid; Week 3 - 150 mg tablet bid; Week 4 - 200 mg tablet bid; Week 5 - 200 mg tablet bid; Week 6 - 150 mg tablet bid OR Week 6 - 200 mg tablet bid~Maintenance Phase (24 Weeks):~200 mg tablet bid OR 150 mg tablet bid~Taper Phase (1 - 3 Weeks):~50 mg tablet bid for 1 week OR 100 mg tablet bid for 1 week OR 150 mg tablet bid for 1 week"
949271|NCT00955305|B3|Baseline|Total|Total of all reporting groups
949272|NCT00955305|B2|Baseline|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
949273|NCT00955305|B1|Baseline|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
949274|NCT00955305|P2|Participant Flow|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
949275|NCT00955305|P1|Participant Flow|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
949276|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
949277|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
949278|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
949279|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
949280|NCT00955305|O2|Outcome|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
949281|NCT00955305|O1|Outcome|Arm A (CPB)|Patients receive carboplatin intravenously (IV) over 30 minutes, paclitaxel IV over 3 hours, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab may continue in the absence of disease progression or unacceptable toxicity.
949282|NCT00955305|E2|Reported Event|Arm B (CPB+Cixutumumab)|Patients receive carboplatin, paclitaxel, and bevacizumab as in Arm A. Patients also receive cixutumumab (IMC-A12) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Treatment with bevacizumab and cixutumumab may continue in the absence of disease progression or unacceptable toxicity.
949286|NCT00955279|B2|Baseline|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
949329|NCT00955110|O4|Outcome|Oxycodone CR 30 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 30 mg.
949291|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949292|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
949293|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
949294|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949295|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
949296|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
949303|NCT00955279|O3|Outcome|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949304|NCT00955279|O2|Outcome|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
949305|NCT00955279|O1|Outcome|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
949306|NCT00955279|E3|Reported Event|Ustekinumab|Ustekinumab was administered subcutaneously at a dose of 180 mg at Week 0 and thereafter at a dose of 90 mg at Week 8, 16 and 24 and matching Placebo was administered subcutaneously at Week 4, 12 and 20.
949307|NCT00955279|E2|Reported Event|Golimumab|Golimumab was administered subcutaneously at a dose of 200 milligram (mg) at Week 0 and thereafter at a dose of 100 mg every 4 weeks up to Week 24.
949308|NCT00955279|E1|Reported Event|Placebo|Matching Placebo was administered subcutaneously (injected under the skin by way of a needle) every 4 weeks up to Week 24.
949309|NCT00955266|B3|Baseline|Total|Total of all reporting groups
949310|NCT00955266|B2|Baseline|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949311|NCT00955266|B1|Baseline|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949312|NCT00955266|P2|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949313|NCT00955266|P1|Participant Flow|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949314|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949315|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949316|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949317|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949318|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949319|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949320|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949321|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949322|NCT00955266|O2|Outcome|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949323|NCT00955266|O1|Outcome|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949324|NCT00955266|E2|Reported Event|Placebo|"Normal saline~Placebo: Normal saline, 50cc delivered over 5 minutes"
949325|NCT00955266|E1|Reported Event|Calcium Choloride|"Calcium chloride, 10mg/kg~Calcium Chloride: Calcium chloride 10mg/kg in 50cc NS delivered over 5 minutes"
949326|NCT00955110|B1|Baseline|All Subjects Randomized to Treatment Phase|Forty one (41) qualified subjects were randomized into the treatment phase (Randomized population). Subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.
949327|NCT00955110|P1|Participant Flow|All Subjects|"Subjects enrolled were healthy non-dependent recreational opioid users. During the Treatment Phase, subjects were randomized to 1 of 10 treatment sequences, according to two 5 × 5 Williams squares. Subjects received single oral doses of each of the following 5 treatments, in a randomized, double-blind, crossover manner (1 capsule per treatment period): Placebo, Oxymorphone ER 15 mg, Oxymorphone ER 30 mg, Oxycodone CR 30 mg, and Oxycodone CR 60 mg.~All participants did not necessarily receive the 5 drug interventions in the order reported as Milestones."
949328|NCT00955110|O5|Outcome|Oxycodone CR 60 mg|Subjects received a single oral dose (1 capsule) of Oxycodone CR 60 mg.
949333|NCT00955110|E5|Reported Event|Treatment Phase Oxycodone CR 60 mg|Single oral dose (1 capsule) of Oxycodone HCl CR 60 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
949334|NCT00955110|E4|Reported Event|Treatment Phase Oxycodone CR 30mg|Single oral dose (1 capsule) of Oxycodone HCl CR 30 mg (OxyContin®), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
949335|NCT00955110|E3|Reported Event|Treatment Phase Oxymorphone ER 30mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 30 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
949336|NCT00955110|E2|Reported Event|Treatment Phase Oxymorphone ER 15 mg|Single oral dose (1 capsule) of Oxymorphone HCl ER 15 mg (OPANA® ER), overencapsulated with size AA Swedish orange capsules with microcrystalline cellulose overfill.
949337|NCT00955110|E1|Reported Event|Treatment Phase Placebo|Identical placebo capsules using size AA Swedish orange capsules and microcrystalline cellulose.
949338|NCT00955032|B3|Baseline|Total|Total of all reporting groups
949339|NCT00955032|B2|Baseline|Sham Treatment|Participants in this group did not receive rTMS treatment.
949340|NCT00955032|B1|Baseline|rTMS Treatment|Participants in this group received rTMS treatment.
949341|NCT00955032|P2|Participant Flow|Sham Treatment|Participants in this group did not receive rTMS treatment.
949342|NCT00955032|P1|Participant Flow|rTMS Treatment|Participants in this group received rTMS treatment.
949343|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
949344|NCT00955032|O3|Outcome|rTMS Post tx|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
949345|NCT00955032|O2|Outcome|Sham Pre tx|Participants in this group were assessed before they received sham treatment.
949346|NCT00955032|O1|Outcome|rTMS Pre tx|Participants in this group were assessed before they received rTMS treatment.
949347|NCT00955032|O4|Outcome|Sham Post tx|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
949355|NCT00955032|O4|Outcome|Sham Post Tx (Immediate)|Participants in this group did not receive rTMS treatment and were assessed approximately 10 days after tx began.
949356|NCT00955032|O3|Outcome|rTMS Post TX (Immediate)|Participants in this group received rTMS treatment and were assessed approximately 10 days after tx began.
949357|NCT00955032|O2|Outcome|Sham Pre TX|Participants in this group were assessed before sham treatment.
949358|NCT00955032|O1|Outcome|rTMS Pre TX|Participants in this group were assessed prior to rTMS treatment.
949359|NCT00955032|E2|Reported Event|Sham Treatment|Participants in this group did not receive rTMS treatment.
949360|NCT00955032|E1|Reported Event|rTMS Treatment|Participants in this group received rTMS treatment.
949361|NCT00954993|B1|Baseline|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
949362|NCT00954993|P1|Participant Flow|Vaniprevir 600 mg - 300 mg Arm|For each participant in period 1, 600 mg of Vaniprevir was taken twice daily on Days 1-3 and a single dose of Vaniprevir 600 mg was taken on Day 4. Period 1 was followed by a minimum 30-day, up to approximately 140 day, washout interval. In period 2, 300 mg of Vaniprevir was taken by each participant twice daily on Days 1-3 and a single dose of Vaniprevir 300 mg was taken on Day 4.
949363|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
949364|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
949365|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
949366|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
949367|NCT00954993|O2|Outcome|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
949368|NCT00954993|O1|Outcome|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
949369|NCT00954993|E2|Reported Event|300 mg Dose of Vaniprevir|300 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 2 and a single dose of Vaniprevir 300 mg was taken on Day 4 of Period 2.
949370|NCT00954993|E1|Reported Event|600 mg Dose of Vaniprevir|600 mg of Vaniprevir was taken twice daily on Days 1-3 of Period 1 and a single dose of Vaniprevir 600 mg was taken on Day 4 of Period 1.
949371|NCT00954941|B3|Baseline|Total|Total of all reporting groups
949414|NCT00954538|P5|Participant Flow|AD Participants (Part III Only)|AD participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
949563|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949372|NCT00954941|B2|Baseline|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
949373|NCT00954941|B1|Baseline|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
949374|NCT00954941|P2|Participant Flow|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
949375|NCT00954941|P1|Participant Flow|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
949376|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
949377|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
949378|NCT00954941|O2|Outcome|Group 2: Ondansetron + Aprepitant|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Aprepitant : 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose."
950870|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
949379|NCT00954941|O1|Outcome|Group 1: Ondansetron|"Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.~Ondansetron : 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy."
949380|NCT00954941|E2|Reported Event|Group 2: Ondansetron + Aprepitant|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy. Aprepitant 125 mg capsule by mouth every morning while receiving chemotherapy followed by 80 mg capsule by mouth daily while receiving chemotherapy continued till 1 day after last chemotherapy dose.
949381|NCT00954941|E1|Reported Event|Group 1: Ondansetron|Ondansetron 8 mg bolus by vein from 30 minutes before receiving chemotherapy followed by 24 mg by vein continuous infusion daily while receiving chemotherapy until 12 hours after chemotherapy.
949382|NCT00954915|B1|Baseline|Teplizumab|Anti CD-3 monoclonal antibody
949383|NCT00954915|P1|Participant Flow|Teplizumab|Anti CD-3 monoclonal antibody
949384|NCT00954915|O1|Outcome|Teplizumab|anti-CD3 monoclonal antibody
949385|NCT00954915|E1|Reported Event|Teplizumab|Anti CD-3 monoclonal antibody
949386|NCT00954824|B1|Baseline|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
949387|NCT00954824|P1|Participant Flow|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
949388|NCT00954824|O1|Outcome|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
949389|NCT00954824|E1|Reported Event|Endotoxin (LPS)|"Single administration low-dose (3 ng/kg) endotoxin (LPS).~Endotoxin (LPS): Single administration low-dose (3 ng/kg) endotoxin (LPS)."
949390|NCT00954733|B1|Baseline|All Participants|All participants in the study
949391|NCT00954733|P1|Participant Flow|All Participants|All participants undergoing surgery
949392|NCT00954733|O1|Outcome|All Participants|All participants undergoing surgery
949393|NCT00954733|E1|Reported Event|All Participants|All participants undergoing surgery
949394|NCT00954707|B1|Baseline|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949395|NCT00954707|P1|Participant Flow|All Enrolled Subjects|Subjects signed the consent forms and met all protocol defined inclusion criteria and none of the exclusion criteria.
949396|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
951343|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
949397|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949398|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949399|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949400|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949401|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949402|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949403|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
950871|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
949404|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949405|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949406|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949407|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949408|NCT00954707|O1|Outcome|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949409|NCT00954707|E1|Reported Event|CYPHER® Stent|"The CYPHER® Sirolimus-eluting Coronary Stent is a BX Velocity stent design and is laser cut from 316L stainless steel seamless tubing and electropolished. The stent design is intended to balance radial strength and closed cell architecture with longitudinal flexibility in both unexpanded and expanded forms. The design can be broken into two distinct components: the radial expansion ring segments and the flexible connectors in an alternating fashion."
949410|NCT00954538|B3|Baseline|Total|Total of all reporting groups
949411|NCT00954538|B2|Baseline|AD Participants (Part II/III)|This group includes AD participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of brain
949412|NCT00954538|B1|Baseline|Healthy Participants (Part I) + HE Participants (Part II/III)|This group includes Healthy participants (Part I) and HE participants (Part II/III). Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
949413|NCT00954538|P6|Participant Flow|HE Participants (Part II + III)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II) / HE Participants who completed Part II could receive a second IV dose of ~150 MBq [18F]MK-3328 in Part III; this dose was followed by PET imaging of the brain
951344|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
949415|NCT00954538|P4|Participant Flow|HE Participants (Part III Only)|HE participants received up to two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
949416|NCT00954538|P3|Participant Flow|Alzheimer's Disease (AD) Participants (Part II Only)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
949417|NCT00954538|P2|Participant Flow|Healthy Elderly (HE) Participants (Part II Only)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
949418|NCT00954538|P1|Participant Flow|Healthy Participants (Part I Only)|Healthy participants received a single intravenous (IV) dose of ~150 megabecquerel (MBq) [18F]MK-3328, followed by Positron Emission Tomography (PET) imaging of the whole body (Part I)
949419|NCT00954538|O2|Outcome|HE Participants (Part III)|HE participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
949420|NCT00954538|O1|Outcome|AD Participants (Part III)|AD participants received two separate IV doses of ~150 MBq [18F]MK-3328; each dose was followed by PET imaging of the brain (Part III)
949421|NCT00954538|O2|Outcome|HE Participants (Part II)|HE participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
949422|NCT00954538|O1|Outcome|AD Participants (Part II)|AD participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the brain (Part II)
949423|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
949424|NCT00954538|O1|Outcome|Healthy Participants (Part I)|Healthy participants received a single IV dose of ~150 MBq [18F]MK-3328, followed by PET imaging of the whole body (Part I)
949425|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
949426|NCT00954538|O1|Outcome|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
949427|NCT00954538|E1|Reported Event|All Study Participants|Participants were administered one or two IV doses of ~150 MBq [18F]MK-3328; all doses were followed by PET imaging of whole body or brain
949428|NCT00954512|B7|Baseline|Total|Total of all reporting groups
949429|NCT00954512|B6|Baseline|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
949430|NCT00954512|B5|Baseline|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949431|NCT00954512|B4|Baseline|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949432|NCT00954512|B3|Baseline|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949433|NCT00954512|B2|Baseline|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949434|NCT00954512|B1|Baseline|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
949435|NCT00954512|P6|Participant Flow|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
949436|NCT00954512|P5|Participant Flow|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949437|NCT00954512|P4|Participant Flow|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949438|NCT00954512|P3|Participant Flow|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949439|NCT00954512|P2|Participant Flow|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949440|NCT00954512|P1|Participant Flow|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
949441|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
949442|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949763|NCT00953407|B3|Baseline|Etafilcon A|Etafilcon A spherical contact lens worn on a daily wear, daily disposable basis
949443|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949444|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949445|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949446|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
949447|NCT00954512|O6|Outcome|Regimen F: Gemcitabine (± Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 IV on Days 1, 8, 15, 22, 29, 36, and 43 in Cycle 1 and on Days 1, 8 and 15 in subsequent cycles (± erlotinib 100 mg per day orally) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle. (Cycle 1 is 8 weeks.)
949448|NCT00954512|O5|Outcome|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949449|NCT00954512|O4|Outcome|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949450|NCT00954512|O3|Outcome|Regimen C: Epirubicin + Cisplatin + 5-FU + Robatumumab|Participants with gastric adenocarcinoma receive epirubicin 50 mg/m^2 IV PLUS cisplatin 60 mg/m^2 IV PLUS 5-FU 200 mg/m^2/day administered via a 21-week continuous IV infusion PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949451|NCT00954512|O2|Outcome|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949452|NCT00954512|O1|Outcome|Regimen A: FOLFIRI (± Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 IV followed by once-weekly doses of 250 mg/m^2 IV) PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 2-week cycle.
949453|NCT00954512|E5|Reported Event|Regimen F: Gemcitabine (+/- Erlotinib) + Robatumumab|Participants with pancreatic adenocarcinoma receive gemcitabine 1000 mg/m^2 on Days 1, 8, 15, 22, 29, 36, and 43 (± erlotinib 100 mg per day) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 8 weeks.
949454|NCT00954512|E4|Reported Event|Regimen E: mTor Inhibitor (Everolimus) + Robatumumab|Participants with renal cell cancer receive mTor inhibitor (everolimus) 10 mg orally once per day PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949455|NCT00954512|E3|Reported Event|Regimen D: Trastuzumab + Robatumumab|Participants with Her2+ breast cancer receive trastuzumab 4 mg/kg IV once every week PLUS robatumumab 10 mg/kg or 20 mg/kg IV on Day 1 of each 4-week cycle.
949456|NCT00954512|E2|Reported Event|Regimen B: Carboplatin + Paclitaxel + Robatumumab|Participants with non-small cell lung cancer receive carboplatin administered at an AUC of 6 mg/mL/min IV PLUS paclitaxel 225 mg/m^2 IV PLUS robatumumab 15 mg/kg IV on Day 1 of each 3-week cycle.
949457|NCT00954512|E1|Reported Event|Regimen A: FOLFIRI (+/- Cetuximab) + Robatumumab|Participants with colorectal adenocarcinoma receive FOLFIRI (Irinotecan 180 mg/m^2+ folinic acid 400 mg/m^2+ 5-FU 400 mg/m^2 bolus followed by 2400 mg/m^2 IV infusion over 46 hours) (± cetuximab initial dose of 400 mg/m^2 followed by once-weekly doses of 250 mg/m^2) PLUS robatumumab 10 mg/kg or 20 mg/kg IV. Each cycle is 2 weeks.
949458|NCT00954447|B3|Baseline|Total|Total of all reporting groups
949459|NCT00954447|B2|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949460|NCT00954447|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949461|NCT00954447|P2|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949462|NCT00954447|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949463|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949464|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949859|NCT00953147|E2|Reported Event|Ciclesonide HFA 160 Mcg Once Daily|
949465|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949466|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949467|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949468|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949469|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949470|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949471|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949472|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949473|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949474|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949475|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949476|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949477|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949478|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949479|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949480|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949481|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949860|NCT00953147|E1|Reported Event|Ciclesonide HFA 80 Mcg Once Daily|
949482|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949483|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949484|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949485|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949486|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949487|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949488|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949489|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949490|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949491|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949492|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949493|NCT00954447|O2|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949494|NCT00954447|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949495|NCT00954447|E2|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5mg, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949496|NCT00954447|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo, orally taken, once daily. During the first 24 weeks of the randomised treatment period, the background dose of basal insulin and/or oral antidiabetic agents was to remain stable. From 24 weeks after randomisation until the end of the trial, adjustments to the dose of basal insulin (but not oral antidiabetic agents) were permitted.
949497|NCT00954421|B1|Baseline|All Subjects|All eligible subjects were enrolled and the intent was to treat for six months on dual lead deep brain stimulation in the VIM and VO regions.
949498|NCT00954421|P1|Participant Flow|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
949561|NCT00953927|P2|Participant Flow|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949861|NCT00953121|B4|Baseline|Total|Total of all reporting groups
949499|NCT00954421|O2|Outcome|TRS Scale Vo Only on vs. Vim Only on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Vo only on -VM only on at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
949500|NCT00954421|O1|Outcome|TRS Scale Both Off vs Both on at 6 Months|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation Periods 4 vs. 5(Both OFF- Both On) at 6 months.~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
949501|NCT00954421|O1|Outcome|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
949502|NCT00954421|E1|Reported Event|Multiple Sclerosis Tremor On VIM and VO|"Multiple Sclerosis Tremor On VIM and VO Deep Brain Stimulation~Deep Brain Stimulation: Use of two ipsilateral thalamic Deep Brain Stimulation electrodes (one at the ventralis intermedius nucleus/ventralis oralis posterior nucleus border or VIM and one at the ventralis oralis anterior nucleus/ventralis oralis posterior nucleus border or VO) for treatment of disabling and medication refractory tremor secondary to head trauma or multiple sclerosis."
949503|NCT00954356|B3|Baseline|Total|Total of all reporting groups
949504|NCT00954356|B2|Baseline|Placebo|5 x matching placebo capsules (administered as a single dose)
949505|NCT00954356|B1|Baseline|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
949506|NCT00954356|P2|Participant Flow|Placebo|5 x matching placebo capsules (administered as a single dose)
949507|NCT00954356|P1|Participant Flow|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
949508|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949509|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949594|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
949510|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949511|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949512|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949513|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949514|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949515|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949516|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949517|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949518|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949519|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949520|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949521|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949522|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949523|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949562|NCT00953927|P1|Participant Flow|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949524|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949525|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949526|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949527|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949528|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949529|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949530|NCT00954356|O2|Outcome|XPF-001|Subjects received a single dose of XPF-001 500 mg after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949531|NCT00954356|O1|Outcome|Placebo|Subjects received a single dose of placebo after reaching moderate pain on a numerical rating scale following surgical extraction of 2 or more impacted third molars, of which at least 1 was a partial or full bony mandibular impaction.
949532|NCT00954356|E2|Reported Event|Placebo|5 x matching placebo capsules (administered as a single dose)
949533|NCT00954356|E1|Reported Event|XPF-001|500 mg XEN402 (5x 100 mg capsules) administered as a single dose
949534|NCT00954187|B3|Baseline|Total|Total of all reporting groups
949535|NCT00954187|B2|Baseline|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
949536|NCT00954187|B1|Baseline|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
949537|NCT00954187|P2|Participant Flow|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
949538|NCT00954187|P1|Participant Flow|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
949539|NCT00954187|O2|Outcome|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
949540|NCT00954187|O1|Outcome|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
949541|NCT00954187|E2|Reported Event|Pregabalin|"Lyrica~pregabalin: 50 mg PO TID"
949542|NCT00954187|E1|Reported Event|Gabapentin|"Neurontin~Gabapentin: Gabapentin - 300 mg three times a day starting two hours prior to surgery and will continue for a total of four days"
949543|NCT00954122|B1|Baseline|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
949544|NCT00954122|P1|Participant Flow|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
949545|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
949546|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
949547|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
949548|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
949549|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
949550|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
949551|NCT00954122|O1|Outcome|Quetiapine Fumarate XR|Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
949552|NCT00954122|E1|Reported Event|Quetiapine Fumarate XR|This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
949553|NCT00954109|B1|Baseline|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
949554|NCT00954109|P1|Participant Flow|Exercise|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
949555|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
949556|NCT00954109|O1|Outcome|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
949557|NCT00954109|E1|Reported Event|Arm 1|"exercise - supervised exercise (treadmill walking or cycle ergometer use)~Exercise: daily exercise: supervised treadmill walking or cycle ergometry use"
949558|NCT00953927|B3|Baseline|Total|Total of all reporting groups
949559|NCT00953927|B2|Baseline|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949560|NCT00953927|B1|Baseline|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949564|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949565|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949566|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949567|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949568|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949569|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949570|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949571|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949572|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949573|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949574|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949575|NCT00953927|O2|Outcome|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949576|NCT00953927|O1|Outcome|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949577|NCT00953927|E2|Reported Event|Control Group|Candida Skin Test Antigen control; subset into cohorts to explore different safety and immunogenicity tests.
949578|NCT00953927|E1|Reported Event|Investigational Vaccine|MVA85A/AERAS-485; subset into cohorts to explore different safety and immunogenicity tests.
949595|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
949596|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
949597|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
949579|NCT00953862|B1|Baseline|Treatment|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
949580|NCT00953862|P1|Participant Flow|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
949581|NCT00953862|O1|Outcome|Atomoxetine Arm|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
949582|NCT00953862|O1|Outcome|Atomoxetine Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
949583|NCT00953862|O1|Outcome|Atomoxetine Arm|Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline. Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial.
951345|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
949584|NCT00953862|E1|Reported Event|Treatment Phase|"Patients who were identified as having adult ADHD on the ACDS were offered an open label treatment trial with atomoxetine, up to 100 mg/day over 10 weeks. Atomoxetine was titrated over a period of four weeks based upon clinical response and observed side effects. All patients receiving atomoxetine gave written informed consent prior to participation and were assessed for ADHD symptoms via the Adult Investigator Adult ADHD Symptom Rating Scale (AISRS) every 1-2 weeks. All patients received a physical exam, review of systems and routine blood work prior to treatment. Data were analyzed for patients completing at least 2 weeks of atomoxetine therapy. Treatment response was pre-hoc defined as having a >=30% reduction in total AISRS scores from baseline.~Atomoxetine : In Phase II, atomoxetine was dispensed beginning at 25 mg/day. Dose was adjusted based on clinical response and tolerability over a 4-week period up to 120mg/day and held constant for the final 6 weeks of the trial."
949585|NCT00953849|B5|Baseline|Total|Total of all reporting groups
949586|NCT00953849|B4|Baseline|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
949587|NCT00953849|B3|Baseline|Arm 3: Celecoxib Plus Calcitriol|Celecoxib + Calcitriol 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg 1,25-dihydroxyvitamin D3) for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)
949588|NCT00953849|B2|Baseline|Arm 2: Calcitriol|Calcitriol Calcitriol (1,25-dihydroxyvitamin D3): 3 week pre-surgical enteral treatment of Calcitriol (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment)
949589|NCT00953849|B1|Baseline|Arm 1: Celecoxib|"Celecoxib:~Celecoxib (400 mg twice daily) oral cancer patients receiving new immunotherapy prior to surgery"
949590|NCT00953849|P4|Participant Flow|Arm 4: No Treatment|no treatment prior to surgery
949591|NCT00953849|P3|Participant Flow|Arm 3: Celecoxib Plus Calcitriol|Treatment with Celecoxib + Calcitriol
949592|NCT00953849|P2|Participant Flow|Arm 2: Calcitriol|Treatment with Calcitriol
949593|NCT00953849|P1|Participant Flow|Arm 1: Celecoxib|Treatment with Celecoxib
950872|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
949598|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
949599|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
949600|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
949601|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
949602|NCT00953849|O4|Outcome|Arm 4: No Treatment|oral cancer patients receiving no immunotherapy prior to surgery
949603|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3 + celecoxib: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment) plus celecoxib (400 mg twice daily)"
949604|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"oral cancer patients receiving new immunotherapy prior to surgery~celecoxib: celecoxib (400 mg twice daily)"
949605|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"oral cancer patients receiving new immunotherapy prior to surgery~1,25-dihydroxyvitamin D3: 3 week pre-surgical enteral treatment of 1,25(OH)2D3 (3 cycles of 4 microg 1,25(OH)2D3 for each of 3 sequential days followed by 4 days of no treatment)"
949606|NCT00953849|O4|Outcome|Arm 4: No Treatment|no treatment prior to surgery
949607|NCT00953849|O3|Outcome|Arm 3: Celecoxib Plus Calcitriol|"Treatment with Celecoxib plus Calcitriol prior to surgery.~Celecoxib plus Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol for each of 3 sequential days followed by 4 days of no treatment) plus Celecoxib (400 mg twice daily)"
949608|NCT00953849|O2|Outcome|Arm 2: Calcitriol|"Treatment with Calcitriol prior to surgery~Calcitriol: 3 week pre-surgical enteral treatment of Calcitriol (1,25-dihydroxyvitamin D3) (3 cycles of 4 microg Calcitriol 3 for each of 3 sequential days followed by 4 days of no treatment)"
949609|NCT00953849|O1|Outcome|Arm 1: Celecoxib|"Celecoxib treatment prior to surgery~Celecoxib: Celecoxib (400 mg twice daily)"
949610|NCT00953849|E4|Reported Event|Arm 4: No Treatment|oral cancer patients receiving no treatment prior to surgery
949611|NCT00953849|E3|Reported Event|Arm 3: Celecoxib Plus Calcitriol|oral cancer patients receiving Celecoxib + Calcitriol prior to surgery
949612|NCT00953849|E2|Reported Event|Arm 2: Calcitriol|oral cancer patients receiving Calcitriol prior to surgery
949613|NCT00953849|E1|Reported Event|Arm 1: Celecoxib|oral cancer patients receiving Celecoxib prior to surgery
949614|NCT00953719|B3|Baseline|Total|Total of all reporting groups
949615|NCT00953719|B2|Baseline|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949616|NCT00953719|B1|Baseline|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949649|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949617|NCT00953719|P2|Participant Flow|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949618|NCT00953719|P1|Participant Flow|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949619|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949620|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949621|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949622|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949623|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949624|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949625|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949626|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949627|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949628|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949629|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949794|NCT00953225|B1|Baseline|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
949630|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949631|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949632|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949633|NCT00953719|O2|Outcome|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949634|NCT00953719|O1|Outcome|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949635|NCT00953719|E2|Reported Event|28 mm Ceramic-on-polyethylene|"28 mm ceramic-on-polyethylene historical control~28 mm ceramic head on a polyethylene acetabular liner : Total hip replacement with a 28 mm ceramic head on a polyethylene liner."
949636|NCT00953719|E1|Reported Event|36 mm Ceramic-on-ceramic|"36 mm ceramic head on ceramic acetabular liner~36 mm ceramic head on a ceramic acetabular liner : Total hip replacement with a 36 mm ceramic head on a ceramic liner"
949637|NCT00953706|B3|Baseline|Total|Total of all reporting groups
949638|NCT00953706|B2|Baseline|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949639|NCT00953706|B1|Baseline|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
949640|NCT00953706|P4|Participant Flow|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949641|NCT00953706|P3|Participant Flow|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949642|NCT00953706|P2|Participant Flow|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949643|NCT00953706|P1|Participant Flow|Placebo – Part A|Placebo matched to ivacaftor tablet orally every 12 hours (q12h) for 16 weeks during Part A (double-blind treatment period).
949644|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949645|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949646|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949647|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949648|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949762|NCT00953407|B4|Baseline|Omafilcon A|Omafilcon A spherical contact lens worn on a daily wear, daily disposable basis
949650|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949651|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949652|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949653|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949654|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949655|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949656|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949657|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949658|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949659|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949660|NCT00953706|O2|Outcome|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949661|NCT00953706|O1|Outcome|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949662|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949663|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949664|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949665|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949666|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949667|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949668|NCT00953706|O2|Outcome|Ivacaftor – Part A|Ivacaftor 150 mg tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949669|NCT00953706|O1|Outcome|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949670|NCT00953706|E4|Reported Event|Ivacaftor/Ivacaftor – Part B|Participants who received ivacaftor during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949671|NCT00953706|E3|Reported Event|Placebo/Ivacaftor – Part B|Participants who received placebo during Part A, received ivacaftor 150 mg tablet orally q12h for 96 weeks during Part B (open-label extension period).
949672|NCT00953706|E2|Reported Event|Ivacaftor – Part A|Ivacaftor 150 milligram (mg) tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949673|NCT00953706|E1|Reported Event|Placebo – Part A|Placebo matched to ivacaftor tablet orally q12h for 16 weeks during Part A (double-blind treatment period).
949674|NCT00953680|B1|Baseline|All Participants|All randomized patients
949675|NCT00953680|P2|Participant Flow|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
949676|NCT00953680|P1|Participant Flow|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
949677|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
949678|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
949679|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
949680|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
949681|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
949682|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
949683|NCT00953680|O2|Outcome|Losartan Tablet + HCTZ Capsule|Single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
949684|NCT00953680|O1|Outcome|Losartan-HCTZ Combination Tablet|single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
949685|NCT00953680|E2|Reported Event|Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet|losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet
949686|NCT00953680|E1|Reported Event|Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule|Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule
949687|NCT00953667|B1|Baseline|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
949688|NCT00953667|P1|Participant Flow|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
949689|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
949690|NCT00953667|O1|Outcome|Niacin/Endotoxin|Niacin/Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
949691|NCT00953667|E1|Reported Event|Niacin and Endotoxin|Immediate Release Niacin, Extended Release Niacin, Endotoxin: Subjects receive a one-time 1000mg dose of immediate release Niacin (Niacor pills), a one-time 1000mg dose of extended release Niacin (Niaspan pill) and one-time 1ng/kg injection of endotoxin (LPS).
949692|NCT00953654|B4|Baseline|Total|Total of all reporting groups
949693|NCT00953654|B3|Baseline|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
949694|NCT00953654|B2|Baseline|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
949695|NCT00953654|B1|Baseline|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
949696|NCT00953654|P3|Participant Flow|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
949697|NCT00953654|P2|Participant Flow|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
949698|NCT00953654|P1|Participant Flow|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
949699|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
949700|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
949701|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
949702|NCT00953654|O3|Outcome|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
949703|NCT00953654|O2|Outcome|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
949704|NCT00953654|O1|Outcome|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
949705|NCT00953654|E3|Reported Event|Waiting List Control|Waiting list control condition in which participants will maintain their current lifestyle and will not enter a six-week exercise training intervention, but will complete outcome measures along the same time progression as the intervention arms.
949706|NCT00953654|E2|Reported Event|Aerobic Exercise Training|Six-week dynamic leg cycling exercise condition completed twice weekly and matched to the strength training arm on total positive work completed, total time actively engaged in exercise and weekly load progression.
949707|NCT00953654|E1|Reported Event|Resistance Exercise Training|Lower-body strength training exercise twice weekly for 6 weeks at an intensity progressing from 50% to 75% predicted one-repetition maximum
949708|NCT00953615|B1|Baseline|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
949709|NCT00953615|P1|Participant Flow|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
949710|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
949711|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
949712|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
949713|NCT00953615|O1|Outcome|Thalidomide|Only one subject was enrolled, so study was terminated early.
949714|NCT00953615|E1|Reported Event|Thalidomide|Patients with primary sclerosing cholangitis (PSC) who met with enrollment criteria were treated with 400 mg in the evening for a duration of 6 months
949715|NCT00953524|B5|Baseline|Total|Total of all reporting groups
949716|NCT00953524|B4|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949717|NCT00953524|B3|Baseline|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949718|NCT00953524|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949719|NCT00953524|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949720|NCT00953524|P4|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949721|NCT00953524|P3|Participant Flow|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949722|NCT00953524|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949723|NCT00953524|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949724|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949725|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949726|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949727|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949728|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949729|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949730|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949731|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949732|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949733|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949734|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949735|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949736|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949737|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
950873|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
949738|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949739|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949740|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949741|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949742|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949743|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949744|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949745|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949746|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949747|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949748|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949749|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949750|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949751|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949752|NCT00953524|O4|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949753|NCT00953524|O3|Outcome|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949754|NCT00953524|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949755|NCT00953524|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949756|NCT00953524|E4|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
949757|NCT00953524|E3|Reported Event|A/H1N1 Vaccine Group 3|Participants who received a dose of A/H1N1 Vaccine (30 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949758|NCT00953524|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of A/H1N1 Vaccine (15 µg hemagglutinin) intramuscularly, on Day 1 and Day 21, respectively.
949759|NCT00953524|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of A/H1N1 vaccine (7.5 µg hemagglutinin) intramuscularly on Day 1 and Day 21, respectively.
949760|NCT00953407|B6|Baseline|Total|Total of all reporting groups
949761|NCT00953407|B5|Baseline|Hilafilcon B|Hilafilcon B spherical contact lens worn on a daily wear, daily disposable basis
951346|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
949764|NCT00953407|B2|Baseline|Narafilcon A|Narafilcon A spherical contact lens worn on a daily wear, daily disposable basis
949765|NCT00953407|B1|Baseline|Nelfilcon A|Nelfilcon A spherical contact lens worn on a daily wear, daily disposable basis
949766|NCT00953407|P5|Participant Flow|Hilafilcon B|Hilafilcon B contact lens
949767|NCT00953407|P4|Participant Flow|Omafilcon A|Omafilcon A contact lens
949768|NCT00953407|P3|Participant Flow|Etafilcon A|Etafilcon A contact lens
949769|NCT00953407|P2|Participant Flow|Narafilcon A|Narafilcon A contact lens
949770|NCT00953407|P1|Participant Flow|Nelfilcon A|Nelfilcon A contact lens
949771|NCT00953407|O5|Outcome|Hilafilcon B|Hilafilcon B contact lens
949772|NCT00953407|O4|Outcome|Omafilcon A|Omafilcon A contact lens
949773|NCT00953407|O3|Outcome|Etafilcon A|Etafilcon A contact lens
949774|NCT00953407|O2|Outcome|Narafilcon A|Narafilcon A contact lens
949775|NCT00953407|O1|Outcome|Nelfilcon A|Nelfilcon A contact lens
949776|NCT00953407|E5|Reported Event|Hilafilcon B|Hilafilcon B contact lens
949777|NCT00953407|E4|Reported Event|Omafilcon A|Omafilcon A contact lens
949778|NCT00953407|E3|Reported Event|Etafilcon A|Etafilcon A contact lens
949779|NCT00953407|E2|Reported Event|Narafilcon A|Narafilcon A contact lens
949780|NCT00953407|E1|Reported Event|Nelfilcon A|Nelfilcon A contact lens
949781|NCT00953329|B1|Baseline|Group 1|
949782|NCT00953329|P1|Participant Flow|Alefacept Treated|
949783|NCT00953329|O1|Outcome|Alefacept|50 mg
949784|NCT00953329|E1|Reported Event|Group 1|
949785|NCT00953290|B1|Baseline|Treated And Untreated Thigh|Treated and untreated arms (left and right thighs) on the same subject.
949786|NCT00953290|P1|Participant Flow|Treated and Untreated Thigh|Circumference measurement of RF treated thigh compared to untreated thigh (average of 2.8 treatments and average dosage of 27 kJ) on the same subject
949787|NCT00953290|O1|Outcome|Treated and Untreated Mid Thigh|Treated and untreated arms (left and right thigh) on the same subject
949788|NCT00953290|O1|Outcome|Treated Thigh|
949789|NCT00953290|O1|Outcome|Treated and Untreated Thigh|
949790|NCT00953290|O1|Outcome|Treated and Untreated Upper Thigh|Treated and untreated arms (left and right thigh) on the same participant
949791|NCT00953290|E1|Reported Event|Treated Thigh|
949792|NCT00953225|B3|Baseline|Total|Total of all reporting groups
949793|NCT00953225|B2|Baseline|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
949795|NCT00953225|P2|Participant Flow|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
949796|NCT00953225|P1|Participant Flow|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
949797|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
949798|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
949799|NCT00953225|O2|Outcome|Placebo|"Placebo daily for one year~Placebo daily for one year: Placebo"
949800|NCT00953225|O1|Outcome|Vitamin D3|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
949801|NCT00953225|E2|Reported Event|Arm 2|"Placebo daily for one year~Placebo daily for one year: Placebo"
949802|NCT00953225|E1|Reported Event|Arm 1|"4,000 IU vitamin D3 daily for one year~vitamin D3: 4,000 IU daily for one year"
949803|NCT00953160|B1|Baseline|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
949804|NCT00953160|P1|Participant Flow|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
949805|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
949806|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
949807|NCT00953160|O1|Outcome|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
949808|NCT00953160|E1|Reported Event|Radiofrequency (RF) Treatment|Abdomen, flank or thigh treated with RF device (average of 2 treatments and average dosage of 30kJ)
949809|NCT00953147|B4|Baseline|Total|Total of all reporting groups
949810|NCT00953147|B3|Baseline|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949811|NCT00953147|B2|Baseline|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949812|NCT00953147|B1|Baseline|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949813|NCT00953147|P3|Participant Flow|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949814|NCT00953147|P2|Participant Flow|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949815|NCT00953147|P1|Participant Flow|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949816|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949817|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949818|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949819|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949896|NCT00953056|P3|Participant Flow|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
949820|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949821|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949822|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949823|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949824|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949825|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949826|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949827|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949828|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949829|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949830|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949831|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949832|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949833|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949834|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949835|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949920|NCT00953043|B2|Baseline|Placebo|Subjects randomized to this arm received placebo medication for three days.
949836|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949837|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949838|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949839|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949840|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949841|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949842|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949843|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949844|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949845|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949846|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949847|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949848|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949849|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949850|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949851|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949852|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949853|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949854|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949855|NCT00953147|O3|Outcome|Placebo Once Daily|The placebo HFA nasal aerosol is identical to active drug, but does not contain ciclesonide.
949856|NCT00953147|O2|Outcome|Ciclesonide HFA 160 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 80 mcg canister, to be administered as 1 puff in each nostril (160 mcg per day).
949857|NCT00953147|O1|Outcome|Ciclesonide HFA 80 Mcg Once Daily|Ciclesonide HFA nasal aerosol will be supplied in a 40 mcg canister, to be administered as 1 puff in each nostril (80 mcg per day).
949858|NCT00953147|E3|Reported Event|Placebo Once Daily|
949862|NCT00953121|B3|Baseline|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949863|NCT00953121|B2|Baseline|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949864|NCT00953121|B1|Baseline|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949865|NCT00953121|P3|Participant Flow|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949866|NCT00953121|P2|Participant Flow|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949917|NCT00953056|E2|Reported Event|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
949918|NCT00953056|E1|Reported Event|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
949919|NCT00953043|B3|Baseline|Total|Total of all reporting groups
949867|NCT00953121|P1|Participant Flow|Grade IV, No Bevacizumab Failure|"Recurrent Glioblastoma Multiforme (GBM) patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an area under the curve (AUC) of 4."
949868|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949869|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949870|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949871|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949872|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949873|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949874|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949897|NCT00953056|P2|Participant Flow|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
951347|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
949875|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949876|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949877|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949878|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949879|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949880|NCT00953121|O3|Outcome|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949881|NCT00953121|O2|Outcome|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949882|NCT00953121|O1|Outcome|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949883|NCT00953121|E3|Reported Event|Grade IV, Bevacizumab Failure|"Recurrent Grade IV GBM patients who have failed prior bevacizumab therapy, but not prior CPT-11 or carboplatin therapies~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949884|NCT00953121|E2|Reported Event|Grade III, No Bevacizumab Failure|"Recurrent Grade 3 malignant glioma patients who have not previously failed either bevacizumab, irinotecan or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949885|NCT00953121|E1|Reported Event|Grade IV, No Bevacizumab Failure|"Recurrent GBM patients who have not previously failed bevacizumab, irinotecan, or carboplatin~bevacizumab and CPT-11 and Carboplatin : Bevacizumab will be administered at 10mg/kg with irinotecan every other week. The dose of irinotecan will be 125 mg/m2 for patients not on CYP3A-inducing anti=epileptics (EIAEDs) and 340 mg/m2 for patients on EIAEDs. All patients will also receive carboplatin on day 1 of each 28-day treatment cycle. Carboplatin will be dosed to achieve an AUC of 4."
949886|NCT00953056|B7|Baseline|Total|Total of all reporting groups
949887|NCT00953056|B6|Baseline|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
949888|NCT00953056|B5|Baseline|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
949889|NCT00953056|B4|Baseline|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
949890|NCT00953056|B3|Baseline|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
949891|NCT00953056|B2|Baseline|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
949892|NCT00953056|B1|Baseline|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
949893|NCT00953056|P6|Participant Flow|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
949894|NCT00953056|P5|Participant Flow|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
949895|NCT00953056|P4|Participant Flow|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
949898|NCT00953056|P1|Participant Flow|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
949899|NCT00953056|O2|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
949900|NCT00953056|O1|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
949901|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
949902|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
949903|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
949904|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
949905|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
949906|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
949907|NCT00953056|O6|Outcome|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
949908|NCT00953056|O5|Outcome|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
949909|NCT00953056|O4|Outcome|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
949910|NCT00953056|O3|Outcome|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
949911|NCT00953056|O2|Outcome|Cohort I - Placebo, Adults|Adults randomized to receive a single dose of matching placebo to RotaTeq™.
949912|NCT00953056|O1|Outcome|Cohort I - RotaTeq™, Adults|Adults randomized to receive a single dose of RotaTeq™.
949913|NCT00953056|E6|Reported Event|Cohort III - Placebo, Infants|Infants randomized to receive 3 doses of matching placebo to RotaTeq™.
949914|NCT00953056|E5|Reported Event|Cohort III - RotaTeq™, Infants|Infants randomized to receive 3 doses of RotaTeq™.
949915|NCT00953056|E4|Reported Event|Cohort II - Placebo, Children|Children randomized to receive a single dose of matching placebo to RotaTeq™.
949916|NCT00953056|E3|Reported Event|Cohort II - RotaTeq™, Children|Children randomized to receive a single dose of RotaTeq™.
949921|NCT00953043|B1|Baseline|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949922|NCT00953043|P2|Participant Flow|Placebo|Subjects randomized to this arm received placebo medication for three days.
949923|NCT00953043|P1|Participant Flow|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949924|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949925|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949926|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949927|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949928|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949929|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949930|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949931|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949932|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949933|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949934|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949935|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949936|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949937|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949938|NCT00953043|O2|Outcome|Placebo|Subjects randomized to this arm received placebo medication for three days.
949939|NCT00953043|O1|Outcome|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949940|NCT00953043|E2|Reported Event|Placebo|Subjects randomized to this arm received placebo medication for three days.
949941|NCT00953043|E1|Reported Event|Lubiprostone|Subjects randomized to this arm received 24 micrograms of lubiprostone per day for three days.
949942|NCT00953017|B5|Baseline|Total|Total of all reporting groups
949943|NCT00953017|B4|Baseline|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
949944|NCT00953017|B3|Baseline|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949945|NCT00953017|B2|Baseline|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949946|NCT00953017|B1|Baseline|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949947|NCT00953017|P4|Participant Flow|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
949948|NCT00953017|P3|Participant Flow|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949949|NCT00953017|P2|Participant Flow|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949950|NCT00953017|P1|Participant Flow|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949951|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
949952|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949953|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
950874|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
949954|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949955|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
949956|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949957|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949958|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949959|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
949960|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949961|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949962|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949963|NCT00953017|O4|Outcome|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
949996|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
951348|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
949964|NCT00953017|O3|Outcome|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949965|NCT00953017|O2|Outcome|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949966|NCT00953017|O1|Outcome|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949967|NCT00953017|E4|Reported Event|Golytely (Polyethylene Glycol)|106 patients will take 1 gallon of golytley (Polyethylene glycol) and drink 1/2 of the solution at 4 p.m. The remaining 1/2 of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy
949968|NCT00953017|E3|Reported Event|Miralax|106 patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949969|NCT00953017|E2|Reported Event|Miralax Plus Dulcolax|107 patients randomized to Miralax plus Dulcolax will take two 5mg tablets of Dulcolax at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949970|NCT00953017|E1|Reported Event|Miralax Plus Amitiza|106 patients randomized to Miralax plus Amitiza will take one 24mcg gelcap of Amitiza at noon the day prior to their colonoscopy. On the day prior to the colonoscopy, the patients will mix 255gm of Miralax with 64 oz. of Gatorade and drink 32 oz. of the solution at 4 p.m. The remaining 32 oz. of the solution will be completed the morning of the procedure, approximately 4-6 hours prior to the scheduled start time of the colonoscopy.
949971|NCT00952848|B1|Baseline|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
949972|NCT00952848|P1|Participant Flow|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
950875|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
949973|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
949974|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
949975|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
949976|NCT00952848|O1|Outcome|MC5-A Pain Treatment Device|Patients treated with the MC5-A device for chronic chemotherapy-induced peripheral neuropathy
949977|NCT00952848|E1|Reported Event|MC5-A Scrambler Instrument|Treatment of chronic neuropathic pain with the MC5-A device
949978|NCT00952822|B1|Baseline|Treated Participants|Participants who received at least 1 infusion
949979|NCT00952822|P4|Participant Flow|Pediatrics - 5 mL Then 2 mL|Pediatrics - 5 mL then 2 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
949980|NCT00952822|P3|Participant Flow|Pediatrics - 2 mL Then 5 mL|Pediatrics - 2 mL then 5 mL: Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
949981|NCT00952822|P2|Participant Flow|Adolescents/Adults - 5 mL Then 2 mL|Adolescents/Adults - 5 mL then 2 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 2 mL SWFI for the 2nd PK Evaluation.
949982|NCT00952822|P1|Participant Flow|Adolescents/Adults - 2 mL Then 5 mL|Adolescents/Adults - 2 mL then 5 mL: Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI for the 1st Pharmacokinetic (PK) Evaluation, then rAHF-PFM reconstituted in 5 mL SWFI for the 2nd PK Evaluation.
949983|NCT00952822|O4|Outcome|Pediatrics at Least 5 Years of Age - 5 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=7)
949984|NCT00952822|O3|Outcome|Pediatrics at Least 5 Years of Age - 2 mL|Participants aged ≥5 years to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI (note: 6 hours after infusion n=7)
949985|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI (note: 24 hours after infusion n=26)
949986|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
949987|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
949988|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
949989|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
949990|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
949991|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
949992|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
949993|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
949994|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
949995|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
949997|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
949998|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
949999|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
950000|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
950001|NCT00952822|O4|Outcome|Pediatrics - 5 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 5 mL SWFI
950002|NCT00952822|O3|Outcome|Pediatrics - 2 mL|Participants aged ≥2 to <12 years who received rAHF-PFM reconstituted in 2 mL SWFI
950003|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
950004|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
950005|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
950006|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
950007|NCT00952822|O2|Outcome|Adolescents/Adults - 5 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 5 mL SWFI
950008|NCT00952822|O1|Outcome|Adolescents/Adults - 2 mL|Participants aged ≥12 to ≤65 years who received rAHF-PFM reconstituted in 2 mL SWFI
950009|NCT00952822|E2|Reported Event|Pediatrics|Participants aged ≥12 to ≤65 years who received at least one infusion
950010|NCT00952822|E1|Reported Event|Adolescents/Adults|Participants aged ≥12 to ≤65 years who received at least one infusion
950011|NCT00952731|B3|Baseline|Total|Total of all reporting groups
950012|NCT00952731|B2|Baseline|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950013|NCT00952731|B1|Baseline|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950114|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950168|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
950014|NCT00952731|P2|Participant Flow|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950015|NCT00952731|P1|Participant Flow|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950016|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950017|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950018|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950019|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950020|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950021|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950022|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950023|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950024|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950025|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950026|NCT00952731|O2|Outcome|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950027|NCT00952731|O1|Outcome|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950028|NCT00952731|E2|Reported Event|Placebo Gel + Oral Treatment|"Placebo gel applied to the breasts daily. 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules).~tamoxifen citrate: 20mg oral tamoxifen taken daily (taken as two (2) 10mg capsules) for 4-10 weeks.~placebo gel: Placebo gel applied to breasts daily for 4-10 weeks."
950029|NCT00952731|E1|Reported Event|Treatment Gel + Oral Placebo|"4-hydroxytamoxifen gel 2mg/breast applied daily. Oral placebo taken daily.~oral placebo: Oral placebo taken daily for 4-10 weeks.~afimoxifene: 2mg/breast applied daily in the form of a gel for 4-10 weeks."
950030|NCT00952705|B4|Baseline|Total|Total of all reporting groups
950031|NCT00952705|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950032|NCT00952705|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950033|NCT00952705|B1|Baseline|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950034|NCT00952705|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950035|NCT00952705|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950169|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
950036|NCT00952705|P1|Participant Flow|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950037|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
950038|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950039|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
950040|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950041|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
950042|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950043|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
950044|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950045|NCT00952705|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
950046|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950047|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950048|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950049|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950050|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950051|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950052|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950053|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950054|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950115|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950055|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950056|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950057|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950058|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950059|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950060|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950061|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950062|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950063|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950064|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950065|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950149|NCT00952523|P1|Participant Flow|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
951349|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
950066|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950067|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950068|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950069|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950070|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950116|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950071|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950072|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950073|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950074|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950075|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950076|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950077|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950078|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950079|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950080|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950081|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950082|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950083|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950084|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950085|NCT00952705|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950086|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950087|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950166|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
950167|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
950088|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950089|NCT00952705|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950090|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950091|NCT00952705|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm are combined.
950092|NCT00952705|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria was administered intranasally using a BD Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Victoria (B/Malaysia/2506/2004).
950093|NCT00952705|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata was administered intranasally using a Becton Dickinson (BD) Accuspray™ device. A total volume of 0.2 mL was administered intranasally (approximately 0.1 mL into each nostril). Each dose contained 10^7.0 ± 0.5 FFU of each of 3 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), and B/Yamagata (B/Florida/4/2006).
950094|NCT00952705|O1|Outcome|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950095|NCT00952705|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
950096|NCT00952705|E1|Reported Event|Q/LAIV-BFS (MEDI8662)|Q/LAIV-BFS (quadrivalent influenza vaccine) (MEDI8662) was supplied in the blow-fill-seal delivery system that delivers a nominal dose of 0.2 mL into a single nostril. Each dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 cold-adapted, temperature-sensitive, attenuated, 6:2 reassortant influenza virus strains: A/H1N1 (A/South Dakota/6/2007), A/H3N2 (A/Uruguay/716/2007), B/Victoria (B/Malaysia/2506/2004), and B/Yamagata (B/Florida/4/2006).
950097|NCT00952653|B1|Baseline|DVS SR 50 mg, Midazolam 4 mg|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1. DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950098|NCT00952653|P1|Participant Flow|DVS SR 50 mg, Midazolam 4 mg|Midazolam (MDZ) 4 milligram (mg) syrup (2 mg per milliliter [mg/mL]) as a single oral dose Period 1 / Day 1. Desvenlafaxine sustained-release formulation (DVS SR) 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950099|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950100|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950101|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950102|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950103|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950104|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950105|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950106|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950107|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950108|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950109|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950110|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950111|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950112|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950113|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950117|NCT00952653|O2|Outcome|DVS SR 50 mg, Midazolam 4 mg (Period 2)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state); DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950118|NCT00952653|O1|Outcome|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950119|NCT00952653|E3|Reported Event|DVS SR 50 mg + Midazolam 4 mg (Period 2 / Day 6)|DVS SR 50 mg tablet as a single oral dose and midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 2 / Day 6.
950120|NCT00952653|E2|Reported Event|DVS SR 50 mg (Period 2 / Day 1 to Day 5)|DVS SR 50 mg tablet as a single oral dose Period 2 / Day 1 to Day 5 (steady state).
950121|NCT00952653|E1|Reported Event|Midazolam 4 mg (Period 1)|Midazolam 4 mg syrup (2 mg/mL) as a single oral dose Period 1 / Day 1.
950122|NCT00952614|B1|Baseline|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
950123|NCT00952614|P1|Participant Flow|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
950124|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
950125|NCT00952614|O1|Outcome|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide~Measure visual acuity improvement from baseline to time periods of 1,2, and 3 years."
950126|NCT00952614|E1|Reported Event|Retisert for Retinal Vein Occlusion|"0.59 mg Fluocinolone Acetonide (Retisert implant) for Retinal Vein Occlusion~fluocinolone acetonide (Retisert Implant, Bausch and Lomb) : sustained release device consisting of 0.59 mg of fluocinolone acetonide"
950127|NCT00952588|B3|Baseline|Total|Total of all reporting groups
950128|NCT00952588|B2|Baseline|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950129|NCT00952588|B1|Baseline|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950130|NCT00952588|P2|Participant Flow|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950131|NCT00952588|P1|Participant Flow|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950132|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950133|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950134|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950135|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950136|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950137|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950138|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950139|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950140|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950141|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950142|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950143|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950144|NCT00952588|O2|Outcome|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950145|NCT00952588|O1|Outcome|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950146|NCT00952588|E2|Reported Event|LDAC 20mg|LDAC 20 mg, sc, bd, 10 days (400mg per cycle)
950147|NCT00952588|E1|Reported Event|AZD1152 1200mg|AZD1152 1200 mg, iv, 7 day infusion monotherapy
950148|NCT00952523|B1|Baseline|Tretinoin & Adapalene-Benzoyl Peroxide|Tretinoin and Adapalene-Benzoyl Peroxide facial gels applied once daily in a split face model
950150|NCT00952523|O2|Outcome|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene 0.1% and Benzoyl peroxide 2.5%
950151|NCT00952523|O1|Outcome|Tretinoin Facial Gel|Tretinoin facial gel in a 0.04% Pump
950152|NCT00952523|E2|Reported Event|Adapalene-Benzoyl Peroxide Facial Gel|Adapalene-Benzoyl Peroxide facial gel applied once daily in a split face model
950153|NCT00952523|E1|Reported Event|Tretinoin Facial Gel|Tretinoin facial gel applied once daily in a split face model
950154|NCT00952484|B4|Baseline|Total|Total of all reporting groups
950155|NCT00952484|B3|Baseline|Historical Control|De-identified historical controls selected from a natural history database of patients with HPP.
950156|NCT00952484|B2|Baseline|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
950157|NCT00952484|B1|Baseline|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
950158|NCT00952484|P3|Participant Flow|Historical Control|"De-identified historical control patients (i.e., untreated with asfotase alfa) were selected from a longitudinal natural history database of patients with HPP maintained at Shriner’s Hospitals for Children, St. Louis, Missouri.~Historical controls must have had at least two sets of wrist and knee radiographs taken between the ages of 5 years, 0 months and 12 years, 0 months with evidence of open growth plates."
950159|NCT00952484|P2|Participant Flow|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
950160|NCT00952484|P1|Participant Flow|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
950161|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
950162|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
950163|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
950164|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
950165|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
950876|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
950170|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
950171|NCT00952484|O2|Outcome|3 mg/kg Asfotase Alfa|3 mg/kg subcutaneous (SC) injection three times per week.
950172|NCT00952484|O1|Outcome|2 mg/kg Asfotase Alfa|2 mg/kg subcutaneous (SC) injection three times per week.
950173|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
950174|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
950175|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
950176|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
950177|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
950178|NCT00952484|O1|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
950179|NCT00952484|O2|Outcome|Asfotase Alfa Combined|ITT Population: Asfotase alfa 2 mg/kg subcutaneous (SC) injection three times per week or 3 mg/kg subcutaneous (SC) injection three times per week.
950180|NCT00952484|O1|Outcome|Historical Controls|De-identified historical controls selected from a natural history database of patients with HPP.
950181|NCT00952484|E2|Reported Event|Asfotase Alfa 3 mg/kg|3 mg/kg administered thrice weekly as a subcutaneous (SC) injection
950182|NCT00952484|E1|Reported Event|Asfotase Alfa 2 mg/kg|2 mg/kg thrice weekly administered as a subcutaneous (SC) injection
950183|NCT00952419|B4|Baseline|Total|Total of all reporting groups
950184|NCT00952419|B3|Baseline|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950185|NCT00952419|B2|Baseline|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950186|NCT00952419|B1|Baseline|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950187|NCT00952419|P3|Participant Flow|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950188|NCT00952419|P2|Participant Flow|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950189|NCT00952419|P1|Participant Flow|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950190|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950191|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950192|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950193|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950194|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950195|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950196|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950197|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950198|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950199|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950200|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950201|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950202|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950203|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950204|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950205|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950206|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950207|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950208|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950209|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950210|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950211|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950212|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950877|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
950213|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950214|NCT00952419|O3|Outcome|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950215|NCT00952419|O2|Outcome|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950216|NCT00952419|O1|Outcome|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950217|NCT00952419|E3|Reported Event|Placebo Group|Participants who received a dose of placebo (saline) intramuscularly on Day 1 and Day 21, respectively.
950218|NCT00952419|E2|Reported Event|A/H1N1 Vaccine Group 2|Participants who received a dose of 15 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950219|NCT00952419|E1|Reported Event|A/H1N1 Vaccine Group 1|Participants who received a dose of 7.5 μg hemagglutinin intramuscularly on Day 1 and Day 21, respectively.
950220|NCT00952393|B1|Baseline|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
950221|NCT00952393|P1|Participant Flow|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
950222|NCT00952393|O1|Outcome|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
950223|NCT00952393|E1|Reported Event|Pharmacokinetic|"This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.~Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined"
950224|NCT00952367|B1|Baseline|Per-protocol Population|In all, 3641 participants were enrolled; however, 38 were excluded because of violation of inclusion/exclusion criteria and 3 participants were excluded for unavailability of nasopharyngeal swab sample. The record presents demographic and result data for 3600 participants in the per-protocol population. These participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950225|NCT00952367|P1|Participant Flow|All Enrolled Participants|Enrolled participants signed the informed consent form, satisfied all screening criteria, and were eligible to enter the study.
950226|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950227|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950228|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950229|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950230|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950231|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950393|NCT00951912|B1|Baseline|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
950232|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950233|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950234|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950235|NCT00952367|O1|Outcome|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950236|NCT00952367|E1|Reported Event|Per-protocol Population|Enrolled participants completed collection of the nasopharyngeal swab sample, the Epidemiology questionnaire, and 24 hours safety observation.
950237|NCT00952341|B3|Baseline|Total|Total of all reporting groups
950238|NCT00952341|B2|Baseline|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950239|NCT00952341|B1|Baseline|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950240|NCT00952341|P2|Participant Flow|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950241|NCT00952341|P1|Participant Flow|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950242|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950243|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950244|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950245|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950246|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950247|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950248|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950249|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950250|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950251|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950252|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950253|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950254|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950255|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950256|NCT00952341|O2|Outcome|Placebo|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950257|NCT00952341|O1|Outcome|Aprepitant (MK-0869)|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950258|NCT00952341|E2|Reported Event|Placebo, Cycle 1 & Cycle 2|"Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg~Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin"
950259|NCT00952341|E1|Reported Event|Aprepitant (MK-0869), Cycle 1 & Cycle 2|"Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg~Day 1: IV granisetron 3 mg prior to administration of cisplatin~Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg"
950260|NCT00952289|B3|Baseline|Total|Total of all reporting groups
950261|NCT00952289|B2|Baseline|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950262|NCT00952289|B1|Baseline|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950263|NCT00952289|P2|Participant Flow|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950288|NCT00952276|B5|Baseline|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950289|NCT00952276|B4|Baseline|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950414|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950264|NCT00952289|P1|Participant Flow|Ruxolitinib|Participants received ruxolitinib orally twice a day. The starting dose was based on Baseline platelet count. Patients with Baseline platelet count > 200,000/μL began a dose regimen of 20 mg twice daily. Patients with Baseline platelet count of 100,000/μL to 200,000/μL (inclusive) began a dose regimen of 15 mg twice daily. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily. Patients receiving benefit could continue treatment until the later of marketing approval or when the last randomized patient remaining in the study had completed Week 144 (36 months).
950265|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950266|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950267|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950268|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950269|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950270|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950271|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950272|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950273|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950274|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950275|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950276|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950277|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950278|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950279|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950280|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950281|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950282|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950283|NCT00952289|O2|Outcome|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950284|NCT00952289|O1|Outcome|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950285|NCT00952289|E2|Reported Event|Placebo|Placebo tablets matching ruxolitinib were administered orally twice a day at a starting dose based on Baseline platelet count. Doses were titrated using the same guidelines as for active drug. Patients meeting pre-specified requirements were given the opportunity to cross over to ruxolitinib treatment.
950286|NCT00952289|E1|Reported Event|Ruxolitinib|Participants began treatment with ruxolitinib 15 or 20 mg taken orally twice a day based on Baseline platelet count. The dose was adjusted by the Investigator based on efficacy and safety to a maximum of 25 mg twice daily.
950287|NCT00952276|B6|Baseline|Total|Total of all reporting groups
950290|NCT00952276|B3|Baseline|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950291|NCT00952276|B2|Baseline|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950292|NCT00952276|B1|Baseline|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950293|NCT00952276|P5|Participant Flow|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950294|NCT00952276|P4|Participant Flow|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950295|NCT00952276|P3|Participant Flow|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950296|NCT00952276|P2|Participant Flow|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950297|NCT00952276|P1|Participant Flow|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950298|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950299|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950300|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950301|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950302|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950303|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950304|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950305|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950306|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950307|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950308|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950309|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950310|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950311|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950312|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950313|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950314|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
951350|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
950315|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950316|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950317|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950318|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950319|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950320|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950321|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950322|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950323|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950324|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950325|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950326|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950327|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950328|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950329|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950330|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950331|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950332|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950333|NCT00952276|O5|Outcome|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950334|NCT00952276|O4|Outcome|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950335|NCT00952276|O3|Outcome|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950336|NCT00952276|O2|Outcome|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950337|NCT00952276|O1|Outcome|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950338|NCT00952276|E5|Reported Event|Group 5: Placebo|Participants who received a dose of placebo (normal saline) on Day 0
950339|NCT00952276|E4|Reported Event|Group 4: A/H1N1 Vaccine Formulation 4|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) on Day 0
950340|NCT00952276|E3|Reported Event|Group 3: A/H1N1 Vaccine Formulation 3|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) on Day 0
950341|NCT00952276|E2|Reported Event|Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 7.5 µg hemagglutinin (HA) with adjuvant on Day 0
950342|NCT00952276|E1|Reported Event|Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant|Participants who received a dose of A/H1N1 vaccine containing 3.8 µg hemagglutinin (HA) with adjuvant on Day 0
950343|NCT00952211|B3|Baseline|Total|Total of all reporting groups
950344|NCT00952211|B2|Baseline|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
950345|NCT00952211|B1|Baseline|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
950346|NCT00952211|P2|Participant Flow|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
950347|NCT00952211|P1|Participant Flow|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
950348|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
950349|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
950350|NCT00952211|O2|Outcome|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
950351|NCT00952211|O1|Outcome|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
950352|NCT00952211|E2|Reported Event|Sub-therapeutic CPAP|"CPAP administered at sub-therapeutic pressure~CPAP at sub-therapeutic pressure: CPAP delivered at sub-therapeutic pressure at nighttime"
950353|NCT00952211|E1|Reported Event|CPAP|"CPAP at therapeutic pressure~CPAP: CPAP at therapeutic pressure during nighttime"
950354|NCT00952133|B3|Baseline|Total|Total of all reporting groups
950355|NCT00952133|B2|Baseline|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
950356|NCT00952133|B1|Baseline|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
950357|NCT00952133|P2|Participant Flow|Palonosetron With Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
950358|NCT00952133|P1|Participant Flow|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
950359|NCT00952133|O2|Outcome|Placebo|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
950360|NCT00952133|O1|Outcome|Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
950361|NCT00952133|O2|Outcome|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
950362|NCT00952133|O1|Outcome|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
950363|NCT00952133|E2|Reported Event|Palonosetron Only|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Intravenous Palonosetron and Saline solution
950364|NCT00952133|E1|Reported Event|Palonosetron With Dexamethasone|Women/Men 18-55 scheduled for surgery 1-3 hours in duration will be given .075 mg IV Palonosetron (Aloxi) with 8mg IV Dexamethasone (Decadron) before surgery.
950365|NCT00952120|B4|Baseline|Total|Total of all reporting groups
950366|NCT00952120|B3|Baseline|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
950367|NCT00952120|B2|Baseline|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
950368|NCT00952120|B1|Baseline|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
950369|NCT00952120|P3|Participant Flow|GSUC and Vacuum-assisted Closure|These patients had multiple wounds and some of their wounds received GSUC therapy and some of their wounds received VAC.
950370|NCT00952120|P2|Participant Flow|Vacuum-assisted Closure|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by the VAC suction unit at 30 to 125 mmHg through a open cell VAC foam dressing sealed with an occlusive cover.
950371|NCT00952120|P1|Participant Flow|GSUC|Continuous negative pressure therapy from the conclusion of the surgery until dressings were taken down on postoperative day 4 or 5. The negative pressure was delivered by low continuous wall suction at 50 to 125 mmHg via a red rubber catheter placed within standardized gauze dressing moistening with sterile saline and sealed with Ioban occlusive dressing.
950372|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
950373|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
950374|NCT00952120|O2|Outcome|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
950375|NCT00952120|O1|Outcome|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
950376|NCT00952120|E2|Reported Event|Vacuum-assisted Closure|"VAC negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days~VAC: Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)"
950377|NCT00952120|E1|Reported Event|GSUC|"Gauze-based wall suction negative pressure wound therapy for 4-5 days~GSUC: Gauze-based wall suction negative pressure wound therapy"
950378|NCT00952081|B1|Baseline|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
950379|NCT00952081|P1|Participant Flow|Clevidipine,Brain Tumor,Hypertension|Clevidipine(0.5 mg/mL in 20% lipid solution), initiated at 10 mg/h and titrated to effect, was administered as the primary antihypertensive agent for perioperative hypertension, with target BPs of less than 130mm Hg.
950380|NCT00952081|O1|Outcome|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
950381|NCT00952081|E1|Reported Event|Clevidipine,Brain Tumor,Hypertension|21 or older, Clevidipine in brain tumor resection, epilepsy focus resection during acute hypertension under general anesthesia
950382|NCT00952068|B1|Baseline|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950383|NCT00952068|P1|Participant Flow|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950384|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950385|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950386|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950387|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950388|NCT00952068|O1|Outcome|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950389|NCT00952068|E1|Reported Event|Tramadol Contramid® Once-A-Day (OAD)|Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
950390|NCT00951912|B4|Baseline|Total|Total of all reporting groups
950391|NCT00951912|B3|Baseline|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
950392|NCT00951912|B2|Baseline|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
951351|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
950394|NCT00951912|P3|Participant Flow|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
950395|NCT00951912|P2|Participant Flow|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
950396|NCT00951912|P1|Participant Flow|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
950397|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950398|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950399|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950400|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950401|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950402|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950403|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950404|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950405|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950406|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950407|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950408|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950409|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950410|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950411|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950412|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950413|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950415|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950416|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950417|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950418|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950419|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950420|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950421|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950422|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950423|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950424|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950425|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950426|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950427|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950428|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950429|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950430|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950431|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950432|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950433|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950434|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950435|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950436|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950437|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950438|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950439|NCT00951912|O3|Outcome|Geinstein Group|All participants were received 10g soy protein isolated plus 50mg purify genistein daily
950440|NCT00951912|O2|Outcome|Daidzein Group|All participants were received 10g soy protein isolated plus 50mg purify daidzein daily
950441|NCT00951912|O1|Outcome|Placebo Group|All participants were received 10g soy protein isolated without isoflavones daily
950442|NCT00951912|E3|Reported Event|Genistein|Genistein group were given 10g soy protein isolated and 50mg purify genistein
950443|NCT00951912|E2|Reported Event|Daidzein|Daidzein group were given 10g soy protein isolated and 50mg purify daidzein
951352|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
950444|NCT00951912|E1|Reported Event|Placebo|the placebo group were given 10g soy protein isolated without isoflavones
950445|NCT00951899|B3|Baseline|Total|Total of all reporting groups
950446|NCT00951899|B2|Baseline|Placebo|Placebo plus diet and metformin
950447|NCT00951899|B1|Baseline|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950448|NCT00951899|P2|Participant Flow|Placebo|Placebo plus diet and metformin
950449|NCT00951899|P1|Participant Flow|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950450|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950451|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950452|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950453|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950454|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950455|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950456|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950457|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950458|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950459|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950460|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950461|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950462|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950463|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950464|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950465|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950466|NCT00951899|O2|Outcome|Placebo|Placebo plus diet and metformin
950467|NCT00951899|O1|Outcome|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950468|NCT00951899|E2|Reported Event|Placebo|Placebo plus diet and metformin
950469|NCT00951899|E1|Reported Event|Colesevelam|Treatment with colesevelam in addition to metformin and diet
950470|NCT00951821|B3|Baseline|Total|Total of all reporting groups
950497|NCT00951665|P5|Participant Flow|Phase IIa Group A|Participants received maximum tolerated dose (MTD) from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
950471|NCT00951821|B2|Baseline|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
950472|NCT00951821|B1|Baseline|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
950473|NCT00951821|P2|Participant Flow|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
950474|NCT00951821|P1|Participant Flow|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
950475|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
950476|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
950477|NCT00951821|O2|Outcome|Adolescent Treatment Only|"Only adolescent participants will receive cognitive behavioral therapy.~Adolescent only cognitive behavioral therapy (CBT): Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
950478|NCT00951821|O1|Outcome|Concurrent Treatment|"Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent cognitive behavioral therapy (CBT): Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
950479|NCT00951821|E2|Reported Event|Adolescent Treatment Only|"Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.~Adolescent treatment only: Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase"
950526|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
950527|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950480|NCT00951821|E1|Reported Event|Concurrent Treatment|"Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.~Concurrent treatment: Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment."
950481|NCT00951808|B1|Baseline|All Participants|237 subjects enrolled in the feasibility study.
950482|NCT00951808|P3|Participant Flow|Standard Care Observational Cohort|Subjects who are ineligible for or who decline the blood transfusion part of the study participated in the observational portion of the study and received standard care (regular care for acute chest syndrome (ACS)).
950483|NCT00951808|P2|Participant Flow|Standard Care Trial Cohort|Subjects received standard care (regular care for acute chest syndrome (ACS)) without a clinically indicated transfusion.
950484|NCT00951808|P1|Participant Flow|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
950485|NCT00951808|O3|Outcome|Overall|Both adults and children
950486|NCT00951808|O2|Outcome|Children|Age < 18
950487|NCT00951808|O1|Outcome|Adults|Age >= 18
950488|NCT00951808|E1|Reported Event|Blood Transfusion Trial Cohort|Subjects received a transfusion within 6 hours of randomization.
950489|NCT00951665|B7|Baseline|Total|Total of all reporting groups
950490|NCT00951665|B6|Baseline|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
950491|NCT00951665|B5|Baseline|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW intravenously.
950492|NCT00951665|B4|Baseline|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950493|NCT00951665|B3|Baseline|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950494|NCT00951665|B2|Baseline|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950495|NCT00951665|B1|Baseline|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950496|NCT00951665|P6|Participant Flow|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W + paclitaxel 80mg/m^2 QW + pertuzumab Q3W intravenously.
950498|NCT00951665|P4|Participant Flow|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950499|NCT00951665|P3|Participant Flow|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950500|NCT00951665|P2|Participant Flow|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950501|NCT00951665|P1|Participant Flow|Phase Ib Regimen 1|Participants received trastuzumab emtansine (T-DM1) every three weeks (Q3W) + paclitaxel weekly (QW) intravenously.
950502|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
950503|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950504|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950505|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950506|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950507|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950508|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
950509|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950510|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950511|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950512|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950513|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950514|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
950515|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950516|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950517|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950518|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950519|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950520|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
950521|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950522|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950523|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950524|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950525|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950528|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950529|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950530|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950531|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950532|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
950533|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
950534|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
950535|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
950536|NCT00951665|O1|Outcome|Phase Ib|For paclitaxel, plasma concentration-time data were available from 47 patients receiving administration of paclitaxel at QW doses of 65 and 80 mg/m^2.
950537|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
950538|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950539|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950540|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950541|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950542|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
950543|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950544|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950545|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950546|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950547|NCT00951665|O5|Outcome|Phase Ib Cohort 4|Participants received 2.4 mg/kg T-DM1 QW and 80 mg/m^2 paclitaxel QW intravenously.
950548|NCT00951665|O4|Outcome|Phase Ib Cohort F|Participants received 2.4 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950549|NCT00951665|O3|Outcome|Phase Ib Cohort 8|Participants received 2.0 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950550|NCT00951665|O2|Outcome|Phase Ib Cohort 7|Participants received 1.6 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950551|NCT00951665|O1|Outcome|Phase Ib Cohort 6|Participants received 1.2 mg/kg T-DM1 QW and 65 mg/m^2 paclitaxel QW intravenously.
950552|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950553|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950554|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950555|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
950556|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950557|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
950558|NCT00951665|O5|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950559|NCT00951665|O4|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950560|NCT00951665|O3|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950561|NCT00951665|O2|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
950562|NCT00951665|O1|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950563|NCT00951665|O6|Outcome|Phase Ib Cohort 3B|Participants received 3.6 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950564|NCT00951665|O5|Outcome|Phase Ib Cohort D|Participants received 3.0 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950565|NCT00951665|O4|Outcome|Phase Ib Cohort J|Participants received 2.4 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950566|NCT00951665|O3|Outcome|Phase Ib Cohort 1|Participants received 2.4 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
950567|NCT00951665|O2|Outcome|Phase Ib Cohort B|Participants received 2 mg/kg T-DM1 Q3W and 80 mg/m^2 paclitaxel QW intravenously.
950568|NCT00951665|O1|Outcome|Phase Ib Cohort A|Participants received 2 mg/kg T-DM1 Q3W and 65 mg/m^2 paclitaxel QW intravenously.
950569|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received of T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab Q3W intravenously.
950570|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950571|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950572|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950573|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950574|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950575|NCT00951665|O2|Outcome|Phase IIa Group B|Participants received T-DM1 3.6mg/kg Q3W, paclitaxel 80mg/m^2 QW, and pertuzumab 420 mg Q3W intravenously.
950576|NCT00951665|O1|Outcome|Phase IIa Group A|Participants received MTD from Phase Ib i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
951353|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
950577|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950578|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950579|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950580|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950581|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950582|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950583|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950584|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950585|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950586|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950587|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950588|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950589|NCT00951665|O6|Outcome|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
950590|NCT00951665|O5|Outcome|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950591|NCT00951665|O4|Outcome|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950592|NCT00951665|O3|Outcome|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950593|NCT00951665|O2|Outcome|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950594|NCT00951665|O1|Outcome|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950595|NCT00951665|E6|Reported Event|Phase IIa Group B|Participants received MTD from Phase 1b , i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW, plus pertuzumab Q3W intravenously.
950596|NCT00951665|E5|Reported Event|Phase IIa Group A|Participants received MTD from Phase 1b i.e. T-DM1 3.6mg/kg Q3W and paclitaxel 80mg/m^2 QW intravenously.
950597|NCT00951665|E4|Reported Event|Phase Ib Regimen 4|Participants received T-DM1 QW + paclitaxel QW + pertuzumab Q3W intravenously.
950598|NCT00951665|E3|Reported Event|Phase Ib Regimen 3|Participants received T-DM1 QW + paclitaxel QW intravenously.
950599|NCT00951665|E2|Reported Event|Phase Ib Regimen 2|Participants received T-DM1 Q3W + paclitaxel QW + pertuzumab Q3W intravenously.
950600|NCT00951665|E1|Reported Event|Phase Ib Regimen 1|Participants received T-DM1 Q3W + paclitaxel QW intravenously.
950601|NCT00951561|B1|Baseline|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
950602|NCT00951561|P4|Participant Flow|Ibuprofen/Vipon/Vipon/Ibuprofen|
950603|NCT00951561|P3|Participant Flow|Vipon/Ibuprofen/Ibuprofen/Vipon|
950604|NCT00951561|P2|Participant Flow|Ibuprofen/Vipon/Ibuprofen/Vipon|
950605|NCT00951561|P1|Participant Flow|Vipon/Ibuprofen/Vipon/Ibuprofen|Subjects participated for a total of 4 menstrual cycles. Subjects used either VIPON as a medical device or up to 2 ibuprofen tablets (each tablet containing 200 mg ibuprofen) during the first menstrual cycle. Subjects used crossover treatment during second menstrual cycle, randomized for cycle 3, and crossed over for cycle 4. All subjects used tampons for absorption of menstrual fluid during treatment and at least 2 hours post treatment. Subjects taking ibuprofen also used a tampon during treatment.
950606|NCT00951561|O2|Outcome|Ibuprofen|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
950607|NCT00951561|O1|Outcome|VIPON|Subjects completed 4 treatment intervals; each subject was randomized to use the VIPON as their treatment during two intervals and Ibuprofen as their treatment during two intervals.
950608|NCT00951561|E1|Reported Event|Study Participants|Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.
950609|NCT00951509|B1|Baseline|All Subjects|"Power Mobility Road Test (PMRT): All subjects were asked to complete the real world power mobility evaluation via the PMRT.~Computer-Based Test: All subjects were asked to complete the computer-based evaluation designed to simulate real world driving in a 2D environment.~Virtual Reality Test: All subjects were asked to complete the virtual-based evaluation designed to simulate real world driving in a 3D environment."
950610|NCT00951509|P1|Participant Flow|Participants Who Qualified for the Study|All participants who qualified for the study, performed electric power wheelchair (EPW) driving under five driving conditions, while clinicians observed and assessed the EPW users' driving performance. The first four conditions were conducted in virtual environments (with different interfaces in each condition, as listed below) and condition 5 was conducted in the real world - Condition 1 - Desktop screens with no roller systems Condition 2- Desktop screens with roller systems Condition 3 - Immersive virtual reality screens with no roller systems Condition 4 - Immersive virtual reality screens with roller systems Condition 5 - Real world EPW driving
950611|NCT00951509|O5|Outcome|Condition 5|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
950612|NCT00951509|O4|Outcome|Condition 4|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
950613|NCT00951509|O3|Outcome|Condition 3|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
950614|NCT00951509|O2|Outcome|Condition 2|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
950615|NCT00951509|O1|Outcome|Condition 1|Power Mobility Road Test (PMRT): All subjects were evaluated using the PMRT in the five different conditions, and reliability was assessed using Intra-class Correlation (ICC) coefficients.There was no difference in the mean scores between the five different driving conditions.
950616|NCT00951509|E1|Reported Event|Power Mobility Road Test|With 12 structured tasks and 4 dynamic tasks, adding to a total of 16 tasks with a minimum score of 1 and maximum of 4 in each task, it is possible to score in the range of 16 - 64 during a driving trial. To assess the driving performance, the total score for each trial was calculated and expressed as a percentage, termed “Composite score”. A Composite score of 95 % or greater would suggest that the user is a safe driver.
950617|NCT00951483|B3|Baseline|Total|Total of all reporting groups
950618|NCT00951483|B2|Baseline|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
950619|NCT00951483|B1|Baseline|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950620|NCT00951483|P2|Participant Flow|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
950621|NCT00951483|P1|Participant Flow|Intervention Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950622|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950623|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950624|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950625|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950626|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950627|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950628|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950629|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950630|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950631|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950632|NCT00951483|O2|Outcome|Intervention Cohort End of Treatment|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
951354|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
950633|NCT00951483|O1|Outcome|Intervention Cohort Baseline|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950634|NCT00951483|O2|Outcome|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
950635|NCT00951483|O1|Outcome|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950636|NCT00951483|E2|Reported Event|Healthy Control|Participants without major depressive disorder or anxiety are enrolled as a comparison group without intervention. They will undergo baseline psychological and laboratory tests and will be followed for 12 weeks.
950637|NCT00951483|E1|Reported Event|Experimental Cohort|"Patients will undergo baseline psychological and laboratory tests then receive Quetiapine-XR(Seroquel-XR) with flexible dosing at the discretion of the treating physician based on clinical response and tolerability. The dose range will be from 50-300mg. The total duration of the treatment will be 12 weeks.~Quetiapine-XR: Quetiapine-XR (Seroquel-XR) 50-300mg daily for 12 weeks."
950638|NCT00951379|B3|Baseline|Total|Total of all reporting groups
950639|NCT00951379|B2|Baseline|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950640|NCT00951379|B1|Baseline|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950641|NCT00951379|P2|Participant Flow|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950642|NCT00951379|P1|Participant Flow|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950643|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950644|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950645|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950646|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950647|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
950648|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
950649|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
950650|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
950651|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
950652|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
950653|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
950654|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
950655|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
950656|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
950657|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
950658|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
950659|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
950660|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
950661|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
950662|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
950663|NCT00951379|O4|Outcome|Placebo: End of Study|Measure at end of Placebo treatment, approximately 24 weeks
950664|NCT00951379|O3|Outcome|Placebo: Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
950665|NCT00951379|O2|Outcome|Pioglitazone: End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
950666|NCT00951379|O1|Outcome|Pioglitazone: Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
950667|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950668|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950669|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950670|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950671|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950672|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950673|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950674|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950675|NCT00951379|O4|Outcome|Placebo: CRP>5 End of Study|Measure at end of Placebo treatment, approximately 24 weeks
950676|NCT00951379|O3|Outcome|Placebo: CRP> 5 Baseline|Measure at baseline, followed by Placebo treatment three capsules orally/day for 24 weeks
950677|NCT00951379|O2|Outcome|Pioglitazone: CRP>5 End of Study|Measure at end of Pioglitazone treatment, approximately 24 weeks
950678|NCT00951379|O1|Outcome|Pioglitazone: CRP>5 at Baseline|Measure at baseline, followed by Pioglitazone treatment three 15 mg capsules orally/day for 24 weeks
950679|NCT00951379|O2|Outcome|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950680|NCT00951379|O1|Outcome|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950681|NCT00951379|E2|Reported Event|Arm II (Placebo)|Three (3) placebo capsules by mouth once daily for 24 weeks
950682|NCT00951379|E1|Reported Event|Arm I (Pioglitazone Hydrochloride)|Three (3) Pioglitazone 15 mg capsules by mouth once daily for 24 weeks
950683|NCT00951275|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950684|NCT00951275|P1|Participant Flow|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) (maximum dose 800 mg) intravenously (IV) once every 4 weeks for a total of 6 infusions.
950685|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950686|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950687|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950688|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950689|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950690|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950691|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950692|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950693|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950694|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950744|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
950695|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950696|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950697|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950698|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950699|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950700|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950701|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950702|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950703|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950704|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950705|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950706|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950707|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950708|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950709|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950710|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950711|NCT00951275|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950712|NCT00951275|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg (maximum dose 800 mg) IV once every 4 weeks for a total of 6 infusions.
950713|NCT00951171|B3|Baseline|Total|Total of all reporting groups
950714|NCT00951171|B2|Baseline|Standard IUI|Insemination with TOmcat catheter
950715|NCT00951171|B1|Baseline|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
950716|NCT00951171|P2|Participant Flow|Standard IUI|Insemination with TOmcat catheter
950717|NCT00951171|P1|Participant Flow|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
950718|NCT00951171|O2|Outcome|Standard IUI|Insemination with TOmcat catheter
950719|NCT00951171|O1|Outcome|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
950720|NCT00951171|E2|Reported Event|Standard IUI|Insemination with TOmcat catheter
950721|NCT00951171|E1|Reported Event|Cervical Occulsion|Insemination Eliptosphere catheter filled with 1cc of air for 15 minutes. H/S Eliptosphere by Copper surgical (U.S. Patent No. 5,624,399)
950722|NCT00951093|B1|Baseline|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery.
950723|NCT00951093|P1|Participant Flow|Patients Assessed for GERD|Patients assessed for GERD before and after Gastric Bypass Surgery
950724|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
950725|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
950726|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
950727|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
950728|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
950729|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
950730|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
950731|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
950732|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
950733|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
950734|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
950735|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
950736|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
950737|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
950738|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
950739|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
950740|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
950741|NCT00951093|O1|Outcome|Before GBP|Patients assessed for GERD before Gastric Bypass Surgery
950742|NCT00951093|O3|Outcome|39 Months After GBP|Patients assessed for GERD 39 months after Gastric Bypass Surgery
950743|NCT00951093|O2|Outcome|6 Months After GBP|Patients assessed for GERD 6 months after Gastric Bypass Surgery
950878|NCT00950937|O1|Outcome|HIV Group|HIV infected persons
950745|NCT00951093|E1|Reported Event|Patients Assessed for GERD|Patients who had an open gastric bypass were assessed for GERD before and after surgery
950746|NCT00951015|B5|Baseline|Total|Total of all reporting groups
950747|NCT00951015|B4|Baseline|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950748|NCT00951015|B3|Baseline|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950749|NCT00951015|B2|Baseline|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950750|NCT00951015|B1|Baseline|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950751|NCT00951015|P4|Participant Flow|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950752|NCT00951015|P3|Participant Flow|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950753|NCT00951015|P2|Participant Flow|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950754|NCT00951015|P1|Participant Flow|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950755|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950756|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950757|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950758|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950759|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD).
950760|NCT00951015|O1|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
950761|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
950762|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950763|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950764|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950831|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950765|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950766|NCT00951015|O5|Outcome|Overall DTG|All participants who received DTG in any DTG treatment group (DTG 10 mg OD, DTG 25 mg OD, and DTG 50 mg OD)
950767|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950768|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950769|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950770|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950771|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950772|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950773|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950774|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950775|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950776|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950777|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950879|NCT00950937|O2|Outcome|Control Group|Non HIV-infected persons
950778|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950779|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950780|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950781|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950782|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950783|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950784|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950785|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950786|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950787|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950788|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950789|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950790|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950791|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950792|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950793|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950794|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950795|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950796|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950797|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950899|NCT00950859|B3|Baseline|Total|Total of all reporting groups
950798|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950799|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950800|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950801|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950802|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950803|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950804|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950805|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950806|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950807|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950808|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950809|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950843|NCT00951015|E4|Reported Event|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950810|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950811|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950812|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950813|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950814|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950815|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950816|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950817|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950818|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950819|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950820|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950821|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950822|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950823|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950824|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950825|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950826|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950827|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950828|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950829|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950830|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950832|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950833|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950834|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950835|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950836|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950837|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950838|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950839|NCT00951015|O4|Outcome|EFV 600 mg OD|Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
950840|NCT00951015|O3|Outcome|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950841|NCT00951015|O2|Outcome|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950842|NCT00951015|O1|Outcome|DTG 10 mg OD|Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950866|NCT00950937|B1|Baseline|HIV Group|HIV infected persons
950844|NCT00951015|E3|Reported Event|DTG 50 mg OD|Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950845|NCT00951015|E2|Reported Event|DTG 25 mg OD|Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950846|NCT00951015|E1|Reported Event|DTG 10 mg OD|Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
950847|NCT00950963|B3|Baseline|Total|Total of all reporting groups
950848|NCT00950963|B2|Baseline|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
950849|NCT00950963|B1|Baseline|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
950850|NCT00950963|P2|Participant Flow|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
950851|NCT00950963|P1|Participant Flow|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
950852|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
950853|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
950854|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
950855|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
950856|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
950857|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
950900|NCT00950859|B2|Baseline|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950901|NCT00950859|B1|Baseline|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950902|NCT00950859|P2|Participant Flow|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950858|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
950859|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
950860|NCT00950963|O2|Outcome|Standard Care|Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.
950861|NCT00950963|O1|Outcome|Phone Counseling|The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.
950862|NCT00950963|E2|Reported Event|Standard Care|"Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses.~Standard Clinical Care: Patients in the usual care or control group were contacted at the beginning of the study only if they had not had an LDL level in the previous 12 months. A letter requesting their presentation for an LDL test was sent to their last known address along with a lab slip and a reminder to schedule an appointment with their PCP for follow-up of results. No additional contact was made with them by the study nurses."
950863|NCT00950963|E1|Reported Event|Phone Counseling|"The telephone outreach intervention was considered an adjunct to usual care. The study nurse focused on optimizing lipids utilizing published guidelines through phone contact.~Phone Counseling: Patient were contacted on a periodic basis via telephone to address there diabetes care."
950864|NCT00950937|B3|Baseline|Total|Total of all reporting groups
950865|NCT00950937|B2|Baseline|Control Group|Non HIV-infected persons
950884|NCT00950911|B2|Baseline|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950885|NCT00950911|B1|Baseline|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950886|NCT00950911|P2|Participant Flow|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950887|NCT00950911|P1|Participant Flow|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950888|NCT00950911|O2|Outcome|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950889|NCT00950911|O1|Outcome|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950890|NCT00950911|E2|Reported Event|Denosumab 120 mg Q4W / Denosumab 120 mg Q4W|This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950891|NCT00950911|E1|Reported Event|Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W|This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study.
950892|NCT00950872|B1|Baseline|Duet TRS|"Subjects receive Duet TRS~Duet TRS: Patients will have their gastric pouch created with ENDO GIA staplers with Single Use Loading Units with Duet TRS."
950893|NCT00950872|P1|Participant Flow|Duet TRS|Duet TRS is a staple line buttress
950894|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
950895|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
950896|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
950897|NCT00950872|O1|Outcome|Duet TRS|Duet TRS is a staple line buttress
950898|NCT00950872|E1|Reported Event|Duet TRS|Duet TRS is a staple line buttress
950903|NCT00950859|P1|Participant Flow|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950904|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950905|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950906|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950907|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950908|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950909|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950910|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950911|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950912|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950913|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950914|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950915|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950916|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950917|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950918|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950919|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950920|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950921|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950922|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950923|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950924|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950925|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950926|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950927|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950928|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950929|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950930|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950931|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950932|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950933|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950934|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
951465|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
950935|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950936|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950937|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950938|NCT00950859|O2|Outcome|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950939|NCT00950859|O1|Outcome|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950940|NCT00950859|E2|Reported Event|Cohort II (DTG 50 mg BID)|Participants received DTG 50 mg twice a day (BID).
950941|NCT00950859|E1|Reported Event|Cohort I (DTG 50 mg OD)|Participants received dolutegravir (DTG) 50 milligrams (mg) once a day (OD).
950942|NCT00950807|B1|Baseline|All Study Treatments|"The treatment phase was comprised of three 14-day treatment periods, each separated by a 10-14 day washout period. Participants were randomly assigned to receive a sequence of placebo and 2 of the 9 active treatments :~UMEC 62.5, 125, 250, 500, and 1000 µg QD, UMEC 62.5, 125, and 250 µg BID, tiotropium 18 µg QD."
950943|NCT00950807|P10|Participant Flow|Tiotropium 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
950944|NCT00950807|P9|Participant Flow|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950945|NCT00950807|P8|Participant Flow|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950946|NCT00950807|P7|Participant Flow|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950947|NCT00950807|P6|Participant Flow|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950948|NCT00950807|P5|Participant Flow|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950949|NCT00950807|P4|Participant Flow|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950950|NCT00950807|P3|Participant Flow|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950951|NCT00950807|P2|Participant Flow|UMEC 62.5 µg QD|Participants received umeclidinium bromide (UMEC) 62.5 micrograms (µg) in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950952|NCT00950807|P1|Participant Flow|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
950953|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
950954|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950955|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950956|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950957|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950958|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950959|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950960|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950961|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950962|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
950963|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
950964|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950965|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950966|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950967|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950968|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950969|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950970|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950971|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950972|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
950973|NCT00950807|O10|Outcome|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
950974|NCT00950807|O9|Outcome|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950975|NCT00950807|O8|Outcome|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950976|NCT00950807|O7|Outcome|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
951466|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951467|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
950977|NCT00950807|O6|Outcome|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950978|NCT00950807|O5|Outcome|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950979|NCT00950807|O4|Outcome|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950980|NCT00950807|O3|Outcome|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950981|NCT00950807|O2|Outcome|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950982|NCT00950807|O1|Outcome|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
950983|NCT00950807|E10|Reported Event|Tio 18 µg QD|Participants received tiotropium bromide 18 µg in the morning via the HandiHaler and placebo in the evening via DPI B for 14 days.
950984|NCT00950807|E9|Reported Event|UMEC 250 µg BID|Participants received UMEC 250 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950985|NCT00950807|E8|Reported Event|UMEC 125 µg BID|Participants received UMEC 125 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950986|NCT00950807|E7|Reported Event|UMEC 62.5 µg BID|Participants received UMEC 62.5 µg in the morning via DPI A and in the evening via DPI B for 14 days.
950987|NCT00950807|E6|Reported Event|UMEC 1000 µg QD|Participants received UMEC 1000 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950988|NCT00950807|E5|Reported Event|UMEC 500 µg QD|Participants received UMEC 500 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950989|NCT00950807|E4|Reported Event|UMEC 250 µg QD|Participants received UMEC 250 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950990|NCT00950807|E3|Reported Event|UMEC 125 µg QD|Participants received UMEC 125 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950991|NCT00950807|E2|Reported Event|UMEC 62.5 µg QD|Participants received UMEC 62.5 µg in the morning via DPI A and placebo in the evening via DPI B for 14 days.
950992|NCT00950807|E1|Reported Event|Placebo|Participants received matching placebo in the morning via dry powder inhaler (DPI) A and in the evening via DPI B for 14 days.
951027|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951355|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951356|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
950993|NCT00950755|B1|Baseline|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
950994|NCT00950755|P1|Participant Flow|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
950995|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
950996|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
950997|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951054|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951055|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
950998|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
950999|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951000|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951001|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951028|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951072|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951002|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951003|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951004|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951005|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951006|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951007|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951008|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951009|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951010|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951029|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951030|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951011|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951012|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951013|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951014|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951015|NCT00950755|O1|Outcome|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951016|NCT00950755|E1|Reported Event|TST and Iodine I 131 TST|Participants received a dosimetric dose (DD) consisting of 450 milligrams (mg) of tositumomab (TST) intravenously (IV) followed by 5.0 millicurie (mCi) of Iodine I 131 and 35 mg of TST IV. The therapeutic dose (TD) consisting of 450 mg of TST IV, followed by a participant-specific dose of I 131 (75 centigray [cGy] or 65 cGy) and 35 mg of TST IV, was administered 7-14 days after the DD. Participants who had disease progression or had completed at least 2 years of follow-up after administration of TST/I 131 TST during the TD phase and had signed the informed consent to participate in the Long-Term Follow-Up (LTFU) study (BEX104528) were followed for up to 10 years. Participants did not receive any study medication during the LTFU study.
951017|NCT00950742|B3|Baseline|Total|Total of all reporting groups
951018|NCT00950742|B2|Baseline|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951019|NCT00950742|B1|Baseline|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951020|NCT00950742|P2|Participant Flow|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951021|NCT00950742|P1|Participant Flow|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951022|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
951023|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
951024|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
951025|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951026|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression or lack of clinical benefit.
951211|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951031|NCT00950742|O1|Outcome|Afatinib|All patients received both Afatinib and Herceptin. Dose level 1 was continuous daily dosing with Afatinib 20mg tablets and once weekly an intravenous infusion of Herceptin. Dose level 2 was continuous daily dosing with Afatinib 30mg tablets and once weekly an intravenous infusion of Herceptin. Cycle length was 28 days.
951032|NCT00950742|O2|Outcome|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit.
951033|NCT00950742|O1|Outcome|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin until disease progression or lack of clinical benefit. This group includes patients from the dose-escalation cohort and from the expansion cohort.
951034|NCT00950742|E2|Reported Event|Afatinib 30mg + Herceptin|Patients received continuous daily dosing with Afatinib 30mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
951035|NCT00950742|E1|Reported Event|Afatinib 20mg + Herceptin|Patients received continuous daily dosing with Afatinib 20mg film-coated tablets and once weekly an intravenous infusion of Herceptin (4 mg/kg single loading dose to be followed by 2 mg/kg/week i.v.) until disease progression.
951036|NCT00950729|B1|Baseline|Healthy Subjects|
951037|NCT00950729|P1|Participant Flow|Healthy Subjects|
951038|NCT00950729|O1|Outcome|Healthy Subjects|
951039|NCT00950729|O1|Outcome|Healthy Subjects|
951040|NCT00950729|E1|Reported Event|Healthy Subjects|
951041|NCT00950690|B1|Baseline|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
951042|NCT00950690|P1|Participant Flow|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
951043|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
951044|NCT00950690|O1|Outcome|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
951045|NCT00950690|E1|Reported Event|Xalatan|0.005% ophthalmic solution dosed once daily for 3 months
951046|NCT00950664|B3|Baseline|Total|Total of all reporting groups
951047|NCT00950664|B2|Baseline|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
951048|NCT00950664|B1|Baseline|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
951049|NCT00950664|P2|Participant Flow|Botox® First, Then Dysport®|Botox® injection in first intervention period and Dysport® in second intervention period (after washout period)
951050|NCT00950664|P1|Participant Flow|Dysport® First, Then Botox®|Dysport® injection in first intervention period and Botox® in second intervention period (after washout period)
951051|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
951052|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951053|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
951056|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951057|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
951058|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951059|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
951060|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951061|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
951062|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951063|NCT00950664|O2|Outcome|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
951064|NCT00950664|O1|Outcome|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951065|NCT00950664|E2|Reported Event|Botox® (onabotulinumtoxinA)|Botox® administered in either first intervention period or second intervention period
951066|NCT00950664|E1|Reported Event|Dysport® (abobotulinumtoxinA)|Dysport® administered in either first intervention period or second intervention period
951067|NCT00950651|B3|Baseline|Total|Total of all reporting groups
951068|NCT00950651|B2|Baseline|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951069|NCT00950651|B1|Baseline|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951070|NCT00950651|P2|Participant Flow|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951071|NCT00950651|P1|Participant Flow|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951212|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951213|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951073|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951074|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951075|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951076|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951077|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951078|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951079|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951080|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951081|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951082|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951083|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951084|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951085|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951404|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951405|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951086|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951087|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951088|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951089|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951090|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951091|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951092|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951093|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951094|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951095|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951096|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951214|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951097|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951098|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951099|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951100|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951101|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951102|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951103|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951104|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951105|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951106|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951107|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951108|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951109|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951110|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951111|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951112|NCT00950651|O2|Outcome|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951113|NCT00950651|O1|Outcome|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951114|NCT00950651|E2|Reported Event|Tramadol HCl Twice a Day (SR)|The available doses for Tramadol HCl Twice a day (SR) were 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951115|NCT00950651|E1|Reported Event|Tramadol HCl Contramid® Once A Day|The available doses for Tramadol HCl Contramid Once A Day (OAD) were 100 mg, 200 mg, 300 mg or 400 mg daily. Each patient was titrated to his/her optimum dose (based on efficacy and tolerability) and maintained that dose until the end of the study.
951116|NCT00950612|B3|Baseline|Total|Total of all reporting groups
951117|NCT00950612|B2|Baseline|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951118|NCT00950612|B1|Baseline|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951119|NCT00950612|P2|Participant Flow|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951120|NCT00950612|P1|Participant Flow|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951121|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951122|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951123|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951124|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951125|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951126|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951127|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951128|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951129|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951130|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951131|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951132|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951133|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951134|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951135|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951136|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951137|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951138|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951406|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951139|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951140|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951141|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951142|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951143|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951144|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951145|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951146|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951147|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951148|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951149|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951150|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951151|NCT00950612|O2|Outcome|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951152|NCT00950612|O1|Outcome|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951215|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951153|NCT00950612|E2|Reported Event|Placebo Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of physiological saline at Day 0 and Day 30, in the arm’s deltoid region.
951154|NCT00950612|E1|Reported Event|GSK692342 Group|Healthy subjects between and including 13 to 17 years of age at the time of first vaccination, who received 2 doses of the study vaccine at Day 0 and Day 30, in the arm’s deltoid region.
951155|NCT00950599|B9|Baseline|Total|Total of all reporting groups
951156|NCT00950599|B8|Baseline|Placebo (0 & 100 mg Cohort)|
951157|NCT00950599|B7|Baseline|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951158|NCT00950599|B6|Baseline|Placebo (0-40 mg Cohort)|
951159|NCT00950599|B5|Baseline|Saxagliptin 40 mg (0-40 mg Cohort)|
951160|NCT00950599|B4|Baseline|Saxagliptin 20 mg (0-40 mg Cohort)|
951161|NCT00950599|B3|Baseline|Saxagliptin 10 mg (0-40 mg Cohort)|
951162|NCT00950599|B2|Baseline|Saxagliptin 5 mg (0-40 mg Cohort)|
951163|NCT00950599|B1|Baseline|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951164|NCT00950599|P10|Participant Flow|Saxa 0 & 100 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 6 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
951165|NCT00950599|P9|Participant Flow|Saxa 0-40 mg Cohort (Follow-up Period)|The follow-up period is 4 weeks and includes: subjects completing 12 weeks of double-blind dosing (received single blind placebo); subjects who met the hyperglycemic rescue criteria (received open-label metformin in addition to placebo); subjects meeting hyperglycemic discontinuation criteria (received open-label metformin); and subjects who discontinued the double-blind period for reasons other than hyperglycemia (received metformin only if clinically indicated). Open-label metformin was (initiated at 500 mg per day and titrated in 500 mg increments after 2 weeks or as clinically indicated). Additional or alternative antihyperglycemic agents were permitted during the follow-up period as clinically indicated.
951166|NCT00950599|P8|Participant Flow|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
951167|NCT00950599|P7|Participant Flow|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
951168|NCT00950599|P6|Participant Flow|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
951169|NCT00950599|P5|Participant Flow|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
951170|NCT00950599|P4|Participant Flow|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
951171|NCT00950599|P3|Participant Flow|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
951172|NCT00950599|P2|Participant Flow|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
951173|NCT00950599|P1|Participant Flow|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
951174|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
951175|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951176|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951177|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951178|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951179|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951180|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951181|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951182|NCT00950599|O2|Outcome|Placebo (0 & 100 Cohort)|
951183|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951184|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951185|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951186|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951187|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951188|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951189|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951190|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951191|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951192|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951193|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951194|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951195|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951196|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951197|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951198|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
951199|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951200|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
951201|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951202|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
951203|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951204|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
951205|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951206|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
951207|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951208|NCT00950599|O2|Outcome|Placebo (0 & 100 mg Cohort)|
951209|NCT00950599|O1|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951210|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951357|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951358|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951359|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951360|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951361|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951362|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951363|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951364|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951365|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951366|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951367|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951368|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951369|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951370|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951371|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951372|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951373|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951374|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951375|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951376|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951377|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951378|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951379|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951380|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951381|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951382|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951383|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951384|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951385|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951386|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951387|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951388|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951389|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951390|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951391|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951392|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951393|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951394|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951395|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951396|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951397|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951398|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951399|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951400|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951401|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951402|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951403|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951468|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951469|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951470|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951471|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951472|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951473|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951474|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951475|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951476|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951477|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951478|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951479|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951480|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951481|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951482|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951483|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951484|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951485|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951486|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951487|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951488|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951489|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951490|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951491|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951492|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951493|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951494|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951495|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951496|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951497|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951498|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951499|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951500|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951501|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951502|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951503|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951504|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951505|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951506|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951507|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951508|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951509|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951510|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951511|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951512|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951513|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951514|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951515|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951516|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951517|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951518|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951519|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951520|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951521|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951522|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951523|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951524|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951525|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951526|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951527|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951528|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951529|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951530|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951531|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951532|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951533|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951534|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951535|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951536|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951537|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951538|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951539|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951540|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951541|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951542|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951543|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951544|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951545|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951546|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951547|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951548|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951549|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951550|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951551|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951552|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951553|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951554|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951555|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951556|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951557|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951558|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951559|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951560|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951561|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951562|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951563|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951564|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951565|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951566|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951567|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951568|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951569|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951570|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951571|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951572|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951573|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951574|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951575|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951576|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951577|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951578|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951579|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951580|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951581|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951582|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951583|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951584|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951585|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951586|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951587|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951588|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951589|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951590|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951591|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951592|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951593|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951594|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951595|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951596|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951597|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951598|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951599|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951600|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951601|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951602|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951603|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951604|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951605|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951606|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951607|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951608|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951609|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951610|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951611|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951612|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951613|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951614|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951615|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951616|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951617|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951618|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951619|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951620|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951621|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951622|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951623|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951624|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951625|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951626|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951627|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951628|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951629|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951630|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951631|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951632|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951633|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951634|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951635|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951636|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951637|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951638|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951639|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951640|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951641|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951642|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951643|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951644|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951645|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951646|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951647|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951648|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951649|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951650|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951651|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951652|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951653|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951654|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951655|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951656|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951657|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951658|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951659|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951660|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951661|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951662|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951663|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951664|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951665|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951666|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951667|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951668|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951669|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951670|NCT00950599|O8|Outcome|Placebo (0, 100 mg Cohort)|
951671|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0, 100 mg Cohort)|
951672|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951673|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951674|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951675|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951676|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951677|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951678|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951679|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951680|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951681|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951682|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951683|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951684|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951685|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951686|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951687|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951688|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951689|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951690|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951691|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951692|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951693|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951694|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951695|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951696|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951697|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951698|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951699|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951700|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951701|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951702|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951703|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951704|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951705|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951706|NCT00950599|O8|Outcome|Placebo (0 & 100 mg Cohort)|
951707|NCT00950599|O7|Outcome|Saxagliptin 100 mg (0 & 100 mg Cohort)|
951708|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951709|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951710|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951711|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951712|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951713|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951714|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951715|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951716|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951717|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951718|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951719|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951720|NCT00950599|O6|Outcome|Placebo (0-40 mg Cohort)|
951721|NCT00950599|O5|Outcome|Saxagliptin 40 mg (0-40 mg Cohort)|
951722|NCT00950599|O4|Outcome|Saxagliptin 20 mg (0-40 mg Cohort)|
951723|NCT00950599|O3|Outcome|Saxagliptin 10 mg (0-40 mg Cohort)|
951724|NCT00950599|O2|Outcome|Saxagliptin 5 mg (0-40 mg Cohort)|
951725|NCT00950599|O1|Outcome|Saxagliptin 2.5 mg (0-40 mg Cohort)|
951726|NCT00950599|E8|Reported Event|Placebo (0-40 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 12 weeks.
951727|NCT00950599|E7|Reported Event|Placebo (0 & 100 mg Cohort)|The placebo group includes data from subjects randomized to receive blinded placebo for 6 weeks.
951728|NCT00950599|E6|Reported Event|Saxagliptin 5 mg (0-40 mg Cohort)|The Saxagliptin 5 mg group includes data from subjects randomized to receive blinded Saxagliptin 5 mg for 12 weeks.
951729|NCT00950599|E5|Reported Event|Saxagliptin 40 mg (0-40 mg Cohort)|The Saxagliptin 40 mg group includes data from subjects randomized to receive blinded Saxagliptin 40 mg for 12 weeks.
951730|NCT00950599|E4|Reported Event|Saxagliptin 20 mg (0-40 mg Cohort)|The Saxagliptin 20 mg group includes data from subjects randomized to receive blinded Saxagliptin 20 mg for 12 weeks.
951731|NCT00950599|E3|Reported Event|Saxagliptin 2.5 mg (0-40 mg Cohort)|The Saxagliptin 2.5 mg group includes data from subjects randomized to receive blinded Saxagliptin 2.5 mg for 12 weeks
951732|NCT00950599|E2|Reported Event|Saxagliptin 100 mg (0 & 100 mg Cohort)|The Saxagliptin 100 mg group includes data from subjects randomized to receive blinded Saxagliptin 100 mg for 6 weeks.
951733|NCT00950599|E1|Reported Event|Saxagliptin 10 mg (0-40 mg Cohort)|The Saxagliptin 10 mg group includes data from subjects randomized to receive blinded Saxagliptin 10 mg for 12 weeks.
951734|NCT00950352|B3|Baseline|Total|Total of all reporting groups
951735|NCT00950352|B2|Baseline|Placebo|"32 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Placebo: Subjects were given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
951736|NCT00950352|B1|Baseline|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
951737|NCT00950352|P2|Participant Flow|Placebo|"32 subjects with methamphetamine dependence were treated with placebo for 8-9 weeks.~Placebo: Subjects were given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group."
951738|NCT00950352|P1|Participant Flow|Citicoline|"74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks.~Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks."
951739|NCT00950352|O2|Outcome|Placebo|Subjects will be given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
951740|NCT00950352|O1|Outcome|Citicoline|Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
951741|NCT00950352|E2|Reported Event|Placebo|
951742|NCT00950352|E1|Reported Event|Citicoline|
951743|NCT00950300|B3|Baseline|Total|Total of all reporting groups
951744|NCT00950300|B2|Baseline|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951745|NCT00950300|B1|Baseline|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951746|NCT00950300|P2|Participant Flow|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-milligram (mg) fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951765|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951747|NCT00950300|P1|Participant Flow|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 milligrams per meter-squared (mg/m^2) every 21 days for four cycles followed by 5-fluorouracil 500 mg/m^2, epirubicin 75 mg/m^2, and cyclophosphamide 500 mg/m^2 (FEC) every 21 days for four cycles. Herceptin was administered as 8 milligrams per kilogram (mg/kg) on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the Treatment-Free Follow-Up (TFFU) Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the Survival Follow-Up (SFU) Period.
951748|NCT00950300|O1|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951749|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951750|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951751|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951752|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951753|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951754|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951755|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951756|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951757|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951835|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951836|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951758|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951759|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951760|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951761|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951762|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951763|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951764|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951819|NCT00950183|E1|Reported Event|Foot and Ankle Surgery|
951820|NCT00949975|B5|Baseline|Total|Total of all reporting groups
951766|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951767|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951768|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951769|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951770|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951771|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951772|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951773|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951774|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951821|NCT00949975|B4|Baseline|Placebo|Matched Placebo Tablets
951822|NCT00949975|B3|Baseline|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951775|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951776|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951777|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951778|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951779|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951780|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951781|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951782|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951783|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951812|NCT00950183|B1|Baseline|Foot and Ankle Surgery|Our target enrollment was 82 participants. We only enrolled 36 participants. The study was terminated due to low enrollment. As a result, patients were never randomized.
951784|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951785|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951786|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951787|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951788|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951789|NCT00950300|O2|Outcome|Herceptin SC + Chemotherapy|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951790|NCT00950300|O1|Outcome|Herceptin IV + Chemotherapy|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery comprised the Neoadjuvant Treatment Period, and the ten cycles of Herceptin IV after surgery comprised the Adjuvant Treatment Period. Thereafter, participants entered the TFFU Period. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period.
951791|NCT00950300|E8|Reported Event|Herceptin SC (SFU)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period. All adverse events were followed for up to 28 days after last dose as applicable.
951792|NCT00950300|E7|Reported Event|Herceptin IV (SFU)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. Participants who were withdrawn from the Neoadjuvant Treatment Period for any reason, or who experienced disease recurrence during either the Adjuvant Treatment Period or TFFU Period, could be entered into the SFU Period. All adverse events were followed for up to 28 days after last dose as applicable.
951813|NCT00950183|P1|Participant Flow|Foot and Ankle Surgery|
951814|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
951815|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
951816|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
951817|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
951793|NCT00950300|E6|Reported Event|Herceptin SC (TFFU)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. After completion, participants entered the TFFU Period. All adverse events were followed for up to 28 days after last dose, and treatment-related and cardiac adverse events were followed until withdrawal from study. (All serious adverse events were followed for 6 months after last dose regardless of treatment relationship.)
951794|NCT00950300|E5|Reported Event|Herceptin IV (TFFU)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. After completion, participants entered the TFFU Period. All adverse events were followed for up to 28 days after last dose, and treatment-related and cardiac adverse events were followed until withdrawal from study. (All serious adverse events were followed for 6 months after last dose regardless of treatment relationship.)
951837|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951838|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951795|NCT00950300|E4|Reported Event|Herceptin SC (Adjuvant)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The ten cycles of Herceptin SC after surgery were collectively considered the Adjuvant Treatment Period, defined as the time from surgery until 35 days after last dose of study drug. Adverse events were followed from surgery until up to 28 days after last dose of Herceptin.
951796|NCT00950300|E3|Reported Event|Herceptin IV (Adjuvant)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The ten cycles of Herceptin IV after surgery were collectively considered the Adjuvant Treatment Period, defined as the time from surgery until 35 days after last dose of study drug. Adverse events were followed from surgery until up to 28 days after last dose of Herceptin.
951797|NCT00950300|E2|Reported Event|Herceptin SC (Neoadjuvant)|Participants received eight cycles of Herceptin SC plus chemotherapy prior to surgery and ten cycles of Herceptin SC after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as a 600-mg fixed dose given every 21 days. The first eight cycles prior to surgery were collectively considered the Neoadjuvant Treatment Period, defined as the time from first dose until the date of surgery. Adverse events were followed from Baseline until up to 28 days after last dose of Herceptin.
951798|NCT00950300|E1|Reported Event|Herceptin IV (Neoadjuvant)|Participants received eight cycles of Herceptin IV plus chemotherapy prior to surgery and ten cycles of Herceptin IV after surgery. Chemotherapy consisted of docetaxel 75 mg/m^2 every 21 days for four cycles followed by FEC every 21 days for four cycles. Herceptin was administered as 8 mg/kg on Day 1 and then as 6 mg/kg on Day 22 and every 21 days thereafter. The first eight cycles prior to surgery were collectively considered the Neoadjuvant Treatment Period, defined as the time from first dose until the date of surgery. Adverse events were followed from Baseline until up to 28 days after last dose of Herceptin.
951799|NCT00950235|B3|Baseline|Total|Total of all reporting groups
951800|NCT00950235|B2|Baseline|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
951801|NCT00950235|B1|Baseline|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
951802|NCT00950235|P2|Participant Flow|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
951803|NCT00950235|P1|Participant Flow|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
951804|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
951805|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
951806|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
951807|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
951808|NCT00950235|O2|Outcome|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
951809|NCT00950235|O1|Outcome|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
951810|NCT00950235|E2|Reported Event|Weight Management Counseling|"In-person and group session counseling~Weight Management: Two individual counseling session on nutrition and once weekly group sessions including use of food diaries for the remaining weeks of their pregnancy"
951811|NCT00950235|E1|Reported Event|Usual Care|"This arm will receive one additional nutrition counseling session that typically received in the health system. This arm will be compared to our intervention group~Usual Care: Standard nutrition counseling from Health Plan"
951818|NCT00950183|O1|Outcome|Foot and Ankle Surgery|
951823|NCT00949975|B2|Baseline|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951824|NCT00949975|B1|Baseline|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951825|NCT00949975|P4|Participant Flow|Placebo|Matched Placebo Tablets
951826|NCT00949975|P3|Participant Flow|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951827|NCT00949975|P2|Participant Flow|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951828|NCT00949975|P1|Participant Flow|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951829|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951830|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951831|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951832|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951833|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951834|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951839|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951840|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951841|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951842|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951843|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951844|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951845|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951846|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951847|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951848|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951849|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951850|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951851|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951852|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951853|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951854|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951855|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951856|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951857|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951858|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951859|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951860|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951861|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951862|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951863|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951864|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951865|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951866|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951867|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951868|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951869|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951870|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951871|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951872|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951873|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951874|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951875|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951876|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951877|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951878|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951879|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951880|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951881|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951882|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951883|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951884|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951885|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951886|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951887|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951888|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951889|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951890|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951891|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951892|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951893|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951894|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951895|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951896|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951897|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951898|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951899|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951900|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951901|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951902|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951903|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951904|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951905|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951906|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951907|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951908|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951909|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951910|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951911|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951912|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951913|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951914|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951915|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951916|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951917|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951918|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951919|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951920|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951921|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951922|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951923|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951924|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951925|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951926|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951927|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951928|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951929|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951930|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951931|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951932|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951933|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951934|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951935|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951936|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951937|NCT00949975|O4|Outcome|Placebo|Matched Placebo Tablets
951938|NCT00949975|O3|Outcome|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951939|NCT00949975|O2|Outcome|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951940|NCT00949975|O1|Outcome|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951941|NCT00949975|E4|Reported Event|Placebo|Matched Placebo Tablets
951942|NCT00949975|E3|Reported Event|60 mg AZD9668|AZD9668 2x30 mg oral tablets twice daily (bid) for 12 weeks
951943|NCT00949975|E2|Reported Event|20 mg AZD9668|AZD9668 2x10 mg oral tablets twice daily (bid) for 12 weeks
951944|NCT00949975|E1|Reported Event|5 mg AZD9668|AZD9668 2x2.5 mg oral tablets twice daily (bid) for 12 weeks
951945|NCT00949910|B1|Baseline|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951946|NCT00949910|P1|Participant Flow|Erlotinib|Erlotinib was given as a single agent in this expanded access program (EAP) to participants with inoperable, locally advanced, recurrent, or metastatic non-small cell lung cancer (NSCLC). Participants were treated with 150 milligrams (mg) oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951947|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951948|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951949|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951982|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951983|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951950|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951951|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951952|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951953|NCT00949910|O1|Outcome|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951954|NCT00949910|E1|Reported Event|Erlotinib|Erlotinib was given as a single agent in this EAP to participants with inoperable, locally advanced, recurrent, or metastatic NSCLC. Participants were treated with 150 mg oral erlotinib once daily until unacceptable toxicity, disease progression, or withdrawal for any other reason. The dose could be reduced in the event of toxicity, and some participants therefore received 50 or 100 mg once daily. The study completed after every participant had either died or been followed for 6 months after stopping erlotinib.
951955|NCT00949884|B4|Baseline|Total|Total of all reporting groups
951956|NCT00949884|B3|Baseline|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951957|NCT00949884|B2|Baseline|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
951958|NCT00949884|B1|Baseline|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951959|NCT00949884|P3|Participant Flow|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951960|NCT00949884|P2|Participant Flow|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
951961|NCT00949884|P1|Participant Flow|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951962|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951963|NCT00949884|O2|Outcome|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
951964|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951965|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951966|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951967|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951968|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951969|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951970|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951971|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951972|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
952202|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
951973|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951974|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951975|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951976|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951977|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951978|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951979|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951980|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951981|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
953363|NCT00945100|O1|Outcome|Control|2 hours daily patching
951984|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951985|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951986|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951987|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951988|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951989|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951990|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951991|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951992|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951993|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951994|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951995|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951996|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
951997|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
951998|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
951999|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
952000|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
952001|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
952002|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
952003|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
952004|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
952005|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
952006|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
952007|NCT00949884|O3|Outcome|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
952008|NCT00949884|O2|Outcome|Combined Olmesartan|Participants who were randomized to Olmesartan or to Placebo Followed by Olmesartan treatment arms, and received at least 1 high dose of olmesartan (40mg)
952009|NCT00949884|O1|Outcome|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
952010|NCT00949884|E3|Reported Event|Losartan|Losartan 50 mg once daily for four weeks, followed by losartan 100 mg once daily for four weeks
952011|NCT00949884|E2|Reported Event|Placebo Followed by Olmesartan|Placebo capsule of olmesartan once daily for 2 weeks, followed by olmesartan 20 mg once daily for two weeks, followed by olmesartan 40 mg for 4 weeks
952012|NCT00949884|E1|Reported Event|Olmesartan|Olmesartan 20 mg once daily for four weeks followed by 40mg one daily for four weeks.
952013|NCT00949715|B3|Baseline|Total|Total of all reporting groups
952014|NCT00949715|B2|Baseline|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952203|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952015|NCT00949715|B1|Baseline|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952016|NCT00949715|P2|Participant Flow|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952017|NCT00949715|P1|Participant Flow|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952040|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952463|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
952018|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952019|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952020|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952021|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952022|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952023|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952024|NCT00949715|O2|Outcome|RV Mid-Septal Pacing|"Pacing lead located in the right ventricle at the middle of the muscle separating the right and left sides of the heart~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952025|NCT00949715|O1|Outcome|RV Apical Pacing|"Pacing lead located at the bottom of the right ventricle of the heart, in the right ventricular apex~Medtronic or Vitatron Dual-Chamber Pacemaker : A Medtronic or Vitatron market-approved dual-chamber implantable pulse generator (IPG) with atrial tachycardia/atrial fibrillation (AT/AF) trending ability~Medtronic SelectSecure 3830 Lead : Medtronic market-approved SelectSecure Model 3830 bipolar pacing lead"
952026|NCT00949715|E1|Reported Event|No Subjects|No subjects had adverse events or death collected as part of this study.
952027|NCT00949702|B1|Baseline|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952028|NCT00949702|P1|Participant Flow|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952029|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952030|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952031|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952032|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952033|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952034|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952035|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952036|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952037|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952038|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952039|NCT00949702|O1|Outcome|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952041|NCT00949702|E1|Reported Event|Vemurafenib 960 mg|Patients received vemurafenib 960 mg (four 240 mg tablets) bid (bis in die, twice daily) orally until disease progression, unacceptable toxicity, withdrawal of consent, or another reason as determined by the investigator.
952042|NCT00949650|B3|Baseline|Total|Total of all reporting groups
952043|NCT00949650|B2|Baseline|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952044|NCT00949650|B1|Baseline|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952045|NCT00949650|P2|Participant Flow|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952046|NCT00949650|P1|Participant Flow|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952047|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
952048|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952049|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
952050|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
952051|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
952052|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952053|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
952054|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
952055|NCT00949650|O4|Outcome|Afatinib 50mg q.d.|Patients receiving Afatinib monotherapy 50mg once daily (q.d.)after a dose escalation.
952056|NCT00949650|O3|Outcome|Afatinib 40mg q.d.|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952057|NCT00949650|O2|Outcome|Afatinib 30mg q.d.|Patients receiving Afatinib monotherapy 30mg once daily (q.d.)after a dose reduction.
952058|NCT00949650|O1|Outcome|Afatinib 20mg q.d.|Patients receiving Afatinib monotherapy 20mg once daily (q.d.)after a dose reduction.
952059|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952060|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952061|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952062|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952063|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952064|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952065|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952066|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952067|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952068|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952069|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952070|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952071|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952072|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952073|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952074|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952075|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952076|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952545|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952077|NCT00949650|O2|Outcome|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952078|NCT00949650|O1|Outcome|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952079|NCT00949650|E2|Reported Event|Pemetrexed / Cisplatin Chemotherapy|Patients receiving Pemetrexed 500 mg/m^2 after Cisplatin 75 mg/m^2 on Day 1 of each 21-day treatment course up to 6 cycles.
952080|NCT00949650|E1|Reported Event|Afatinib 40mg|Patients receiving Afatinib monotherapy 40mg once daily (q.d.)
952081|NCT00949533|B3|Baseline|Total|Total of all reporting groups
952082|NCT00949533|B2|Baseline|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
952083|NCT00949533|B1|Baseline|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
952151|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952563|NCT00947531|O1|Outcome|Cerebrolysin|
952084|NCT00949533|P2|Participant Flow|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
952085|NCT00949533|P1|Participant Flow|Standard Dose|Oseltamivir (Tamiflu) capsule was administered orally at a dose of 75 milligrams (mg) twice a day (BID) in adult participants and children received oseltamivir powder for oral suspension dose (at 12 milligrams/ milliliter [mg/mL]) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
952086|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
952087|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
952088|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
952089|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
952090|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
952091|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
952092|NCT00949533|O2|Outcome|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
952093|NCT00949533|O1|Outcome|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/mL) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
952094|NCT00949533|E2|Reported Event|Double Dose|Oseltamivir capsule was administered orally at a dose of 150 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 60 mg BID to a maximum dose of 150 mg BID; for 5 days.
952095|NCT00949533|E1|Reported Event|Standard Dose|Oseltamivir capsule was administered orally at a dose of 75 mg BID in adult participants and children received oseltamivir powder for oral suspension dose (at 12 mg/ml) based on their body weight with a starting dose of 30 mg BID to a maximum dose of 75 mg BID; for 5 days.
952096|NCT00949117|B3|Baseline|Total|Total of all reporting groups
952097|NCT00949117|B2|Baseline|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952098|NCT00949117|B1|Baseline|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952099|NCT00949117|P2|Participant Flow|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952100|NCT00949117|P1|Participant Flow|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952101|NCT00949117|O2|Outcome|Cyproheptadine HCl & PediaSure or Ensure|"Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~Ensure: Given orally~PediaSure: Given orally~cyproheptadine hydrochloride: Given orally"
952102|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|"Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.~cyproheptadine hydrochloride: Given orally"
952103|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952104|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952105|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952106|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952107|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952108|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952564|NCT00947531|E2|Reported Event|0.9% Saline Solution|
952565|NCT00947531|E1|Reported Event|Cerebrolysin|
952109|NCT00949117|O2|Outcome|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952110|NCT00949117|O1|Outcome|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952111|NCT00949117|E2|Reported Event|Arm II Cyproheptadine HCl and PediaSure or Ensure|Patients receive oral cyproheptadine hydrochloride twice daily and oral PediaSure (2 to 10 years of age) or Ensure (> 10 years of age) twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952112|NCT00949117|E1|Reported Event|Arm I- Cyproheptadine Hydrochloride|Patients receive oral cyproheptadine hydrochloride twice daily for up to 24 weeks in the absence of weight loss or unacceptable toxicity.
952113|NCT00948896|B9|Baseline|Total|Total of all reporting groups
952114|NCT00948896|B8|Baseline|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952115|NCT00948896|B7|Baseline|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952116|NCT00948896|B6|Baseline|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952117|NCT00948896|B5|Baseline|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
952118|NCT00948896|B4|Baseline|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952119|NCT00948896|B3|Baseline|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952120|NCT00948896|B2|Baseline|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952121|NCT00948896|B1|Baseline|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
952122|NCT00948896|P8|Participant Flow|HIV-exposed & DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952123|NCT00948896|P7|Participant Flow|HIV-exposed & TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952124|NCT00948896|P6|Participant Flow|HIV-exposed & SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952125|NCT00948896|P5|Participant Flow|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
952126|NCT00948896|P4|Participant Flow|HIV-unexposed & DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952127|NCT00948896|P3|Participant Flow|HIV-unexposed & TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952128|NCT00948896|P2|Participant Flow|HIV-unexposed & SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952129|NCT00948896|P1|Participant Flow|HIV-unexposed & No Chemoprevention|HIV-unexposed No chemoprevention was given
952130|NCT00948896|O4|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952131|NCT00948896|O3|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952132|NCT00948896|O2|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952133|NCT00948896|O1|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
952134|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952135|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952136|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952137|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
952138|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952139|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952140|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952141|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
952142|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952143|NCT00948896|O3|Outcome|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952144|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952145|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
952146|NCT00948896|O8|Outcome|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952147|NCT00948896|O7|Outcome|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952148|NCT00948896|O6|Outcome|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952149|NCT00948896|O5|Outcome|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
952150|NCT00948896|O4|Outcome|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952566|NCT00947518|B4|Baseline|Total|Total of all reporting groups
952152|NCT00948896|O2|Outcome|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952153|NCT00948896|O1|Outcome|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
952154|NCT00948896|E8|Reported Event|HIV-exposed & Monthly DP|HIV-exposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952155|NCT00948896|E7|Reported Event|HIV-exposed & Daily TS|HIV-exposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952156|NCT00948896|E6|Reported Event|HIV-exposed & Monthly SP|HIV-exposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952157|NCT00948896|E5|Reported Event|HIV-exposed & no Chemoprevention|HIV-exposed No chemoprevention was given
952158|NCT00948896|E4|Reported Event|HIV-unexposed & Monthly DP|HIV-unexposed dihydroartemisinin-piperaquine (DP): monthly dosing given once a day for 3 consecutive days, 40mg/320mg tabs
952159|NCT00948896|E3|Reported Event|HIV-unexposed & Daily TS|HIV-unexposed trimethoprim-sulfamethoxazole (TS; TMP/SMX): daily dosing, 20mgTMP/100mgSMX tabs, 80mgTMP/400mgSMX tabs
952160|NCT00948896|E2|Reported Event|HIV-unexposed & Monthly SP|HIV-unexposed sulfadoxine-pyrimethamine (SP): monthly dosing given as a single dose, 500mg/25mg tabs
952161|NCT00948896|E1|Reported Event|HIV-unexposed & no Chemoprevention|HIV-unexposed No chemoprevention was given
952162|NCT00948857|B3|Baseline|Total|Total of all reporting groups
952163|NCT00948857|B2|Baseline|Blinded Placebo|Blinded placebo
952164|NCT00948857|B1|Baseline|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
952165|NCT00948857|P2|Participant Flow|Blinded Placebo|Blinded placebo
952166|NCT00948857|P1|Participant Flow|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
952167|NCT00948857|O2|Outcome|Placebo|Blinded placebo
952168|NCT00948857|O1|Outcome|DHEA|Dehydroepiandrosterone 25 mg tid po
952169|NCT00948857|E2|Reported Event|Blinded Placebo|Blinded placebo
952170|NCT00948857|E1|Reported Event|Dehydroepiandrosterone 25 mg Tid po|Dehydroepiandrosterone 25 mg tid po
952171|NCT00948818|B3|Baseline|Total|Total of all reporting groups
952172|NCT00948818|B2|Baseline|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952173|NCT00948818|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
952174|NCT00948818|P2|Participant Flow|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952175|NCT00948818|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
952176|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952177|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952178|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952179|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952180|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952181|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952182|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952183|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952184|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952185|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952186|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952187|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952188|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952189|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952190|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952191|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952192|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952193|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952194|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952195|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952196|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952197|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952198|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952199|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952200|NCT00948818|O2|Outcome|Linaclotide|Linaclotide 290µg, oral administration, once per day.
952201|NCT00948818|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
952204|NCT00948818|E5|Reported Event|Linaclotide to Linaclotide - Randomized Withdrawal Period|Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period
952205|NCT00948818|E4|Reported Event|Linaclotide to Placebo - Randomized Withdrawal Period|"Dose-matched placebo, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received linaclotide 290µg, oral administration, once per day during the 12-week treatment period."
952206|NCT00948818|E3|Reported Event|Placebo to Linaclotide - Randomized Withdrawal Period|"Linaclotide 290µg, oral administration, once per day during a 4-week randomized withdrawal period.~This group had previously received dose-matched placebo during the 12-week randomized treatment period."
952207|NCT00948818|E2|Reported Event|Linaclotide - Treatment Period|Linaclotide 290µg, oral administration, once per day.
952208|NCT00948818|E1|Reported Event|Placebo - Treatment Period|Dose-matched placebo, oral administration, once per day.
952209|NCT00948792|B1|Baseline|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long).
952210|NCT00948792|P1|Participant Flow|Short and Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long).
952211|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
952212|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
952213|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
952214|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
952215|NCT00948792|O2|Outcome|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
952216|NCT00948792|O1|Outcome|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
952217|NCT00948792|E2|Reported Event|Short Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
952218|NCT00948792|E1|Reported Event|Long Transfusion Group|This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.
952219|NCT00948766|B3|Baseline|Total|Total of all reporting groups
952220|NCT00948766|B2|Baseline|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
952221|NCT00948766|B1|Baseline|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952222|NCT00948766|P2|Participant Flow|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
952223|NCT00948766|P1|Participant Flow|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952224|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952225|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952226|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952227|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
952228|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952229|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
952230|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952231|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
952232|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952233|NCT00948766|O2|Outcome|Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
952234|NCT00948766|O1|Outcome|Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952235|NCT00948766|E3|Reported Event|Extension Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952236|NCT00948766|E2|Reported Event|Core Study: Rivastigmine 4.6 mg/24 h Transdermal Patch|Patients received rivastigmine 4.6 mg/24 h (5 cm^2).
952237|NCT00948766|E1|Reported Event|Core Study: Rivastigmine 13.3 mg/24 h Transdermal Patch|Patients received rivastigmine 13.3 mg/24 h (15 cm^2).
952238|NCT00948688|B1|Baseline|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
952239|NCT00948688|P2|Participant Flow|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
952283|NCT00948441|P2|Participant Flow|Heparin Lock/Washout/25% Ethanol|First Heparin lock, then washout period, then 25% ethanol lock
952546|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952240|NCT00948688|P1|Participant Flow|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
952241|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
952258|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952242|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
952243|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
952244|NCT00948688|O2|Outcome|Vorinostat 100 mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
952245|NCT00948688|O1|Outcome|Vorinostat 200 mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
952246|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
952247|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
952248|NCT00948688|O1|Outcome|Vorinostat, 5-FU, Radiation Therapy|"Vorinostat at varying doses; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)~Radiation therapy: Once per day, 5 days a week for 6 weeks~5-FU: Intravenously over 24 hours, 7 days per week during each week of radiation therapy~Vorinostat: Taken orally. Dose will depend upon time of enrollment and how well previous participants tolerated the drug"
952249|NCT00948688|E2|Reported Event|Vorinostat 100mg|Vorinostat 100 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)
952250|NCT00948688|E1|Reported Event|Vorinostat 200mg|Vorinostat 200 mg; orally, days 1-7, weeks 1-6 5-FU 225 mg/m2/day; intravenous over 24 hours; days 1-5, weeks 1-6 until completion of radiation therapy; Radiation therapy; 180cGy daily Monday-Friday; 28 days of treatment (6 weeks)during each week of radiation therapy
952251|NCT00948675|B3|Baseline|Total|Total of all reporting groups
952252|NCT00948675|B2|Baseline|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952253|NCT00948675|B1|Baseline|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952254|NCT00948675|P2|Participant Flow|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952255|NCT00948675|P1|Participant Flow|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952256|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952284|NCT00948441|P1|Participant Flow|25% Ethanol/Washout/Heparin|First 25% ethanol, then Washout, then heparin
952322|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952547|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952257|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952326|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
952327|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952259|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952260|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952261|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952262|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952263|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952264|NCT00948675|O2|Outcome|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952265|NCT00948675|O1|Outcome|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952266|NCT00948675|E2|Reported Event|Paclitaxel + Carboplatin + Bevacizumab|"Induction therapy: paclitaxel 200 mg/m² intravenously infused over 3 hours plus carboplatin AUC 6 (maximum possible dose of 900 mg) intravenously infused over 30 minutes plus bevacizumab 15 milligrams/kilogram (mg/kg) given intravenously for four 21-day cycles.~Maintenance therapy: bevacizumab 15 mg/kg given intravenously every 21 days until disease progression or treatment discontinuation."
952267|NCT00948675|E1|Reported Event|Pemetrexed + Carboplatin|"Induction therapy: pemetrexed 500 milligrams/square meter (mg/m²) given intravenously plus carboplatin area under the curve (AUC) 6 [maximum possible dose of 900 milligrams (mg)] intravenously infused over 30 minutes for four 21-day cycles.~Maintenance therapy: pemetrexed 500 mg/m² given intravenously every 21 days until disease progression or treatment discontinuation."
952268|NCT00948506|B3|Baseline|Total|Total of all reporting groups
952269|NCT00948506|B2|Baseline|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
952270|NCT00948506|B1|Baseline|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
952271|NCT00948506|P2|Participant Flow|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
952272|NCT00948506|P1|Participant Flow|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
952273|NCT00948506|O2|Outcome|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
952274|NCT00948506|O1|Outcome|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
952275|NCT00948506|O3|Outcome|Placebo|Subjects received placebo to one side of the face in a split-face design (1% or 3% cidofovir was applied to the other side of the face).
952276|NCT00948506|O2|Outcome|3% Cidofovir|Subjects received 3% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
952277|NCT00948506|O1|Outcome|1% Cidofovir|Subjects received 1% topical cidofovir to one side of the face in a split-face design (placebo was applied to the other side of the face).
952278|NCT00948506|E2|Reported Event|3% Cidofovir and Placebo|Subjects received 3% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
952279|NCT00948506|E1|Reported Event|1% Cidofovir and Placebo|Subjects received 1% topical cidofovir to one side of the face and placebo to the other side of the face in a split-face design.
952280|NCT00948441|B3|Baseline|Total|Total of all reporting groups
952281|NCT00948441|B2|Baseline|Group 2|Heparin x12 weeks; washout x4 weeks; 25% ethanol x 12 weeks
952282|NCT00948441|B1|Baseline|Group 1|25% ethanol x12 weeks; washout x4 weeks; heparin x12 weeks
952285|NCT00948441|O2|Outcome|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
952286|NCT00948441|O1|Outcome|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
952328|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952287|NCT00948441|O2|Outcome|Infections While Using Heparin Lock|"Heparin lock x 12 weeks~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution was instilled and allowed to dwell for 4 to 12 hours."
952288|NCT00948441|O1|Outcome|Infections While Using Ethanol Lock|"25% ethanol x 12 weeks~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
952289|NCT00948441|E2|Reported Event|Heparin Lock|"Heparin~heparin lock: Placebo Lock - Heparin - These will be prepared in a sterile fashion in the Pharmacy of Children's Hospital of Pittsburgh in 10 day supplies as 1ml lock syringes utilizing 100 units/ml if the central venous catheter is accessed once daily and 10 units/ml if accessed more than once daily. The lock solution will be instilled and allowed to dwell for 4 to 12 hours."
952290|NCT00948441|E1|Reported Event|Ethanol Lock|"25% ethanol~25% ethanol: Study Lock -25% Ethanol– The ethanol lock therapy consists of placing up to 2.3 ml of 25% ethanol into the central venous catheter and allowing it to dwell for 4 to 12 hours per day."
952291|NCT00948389|B6|Baseline|Total|Total of all reporting groups
952292|NCT00948389|B5|Baseline|Dose Level 3B|Dasatinib: 100 mg/day (QD) + CCNU: 90 mg/m²
952293|NCT00948389|B4|Baseline|Dose Level 3A|Dasatinib: 150 mg/day (100 mg AM and 50 mg PM) + CCNU: 90 mg/m²
952294|NCT00948389|B3|Baseline|Dose Level 2|Dasatinib: 100 mg BID + CCNU: 90 mg/m²
952295|NCT00948389|B2|Baseline|Dose Level 1B|Dasatinib: 100 mg QD / 100mg BID + CCNU: 90 mg/m²
952296|NCT00948389|B1|Baseline|Dose Level 1A|Dasatinib: 100 mg once daily (QD) cycle 1 / 100 mg twice daily (BID) cycle 2 + lomustine (CCNU): 110 mg/m²
952297|NCT00948389|P5|Participant Flow|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952298|NCT00948389|P4|Participant Flow|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952299|NCT00948389|P3|Participant Flow|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952300|NCT00948389|P2|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2.
952301|NCT00948389|P1|Participant Flow|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
952302|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952303|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952304|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952305|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
952306|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2
952307|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952308|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952309|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952310|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
952311|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
952312|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952313|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952314|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952315|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
952316|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
952317|NCT00948389|O5|Outcome|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952318|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952319|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952320|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
952321|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
952548|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952323|NCT00948389|O4|Outcome|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952324|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952325|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
952329|NCT00948389|O3|Outcome|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952330|NCT00948389|O2|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
952331|NCT00948389|O1|Outcome|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
952332|NCT00948389|E5|Reported Event|Dasatinib, 100 mg/d QD + Lomustine, 90 mg/m^2|Dose Level 3B: Dasatinib, 100 mg/d QD plus lomustine, 90 mg/m^2
952333|NCT00948389|E4|Reported Event|Dasatinib, 150 mg/d + Lomustine, 90 mg/m^2|Dose level 3A: Dasatinib, 150 mg/d (100 mg AM and 50 mg PM), plus lomustine, 90 mg/m^2
952334|NCT00948389|E3|Reported Event|Dasatinib, 100 mg BID + Lomustine, 90 mg/m^2|Dose level 2. Dasatinib, 100 mg BID plus lomustine, 90 mg/m^2
952335|NCT00948389|E2|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 90 mg/m^2|Dose level 1B. Cycle 1: Dasatinib,100 mg QD. Cycle 2: 100 mg BID, plus lomustine, 90 mg/m^2
952336|NCT00948389|E1|Reported Event|Dasatinib, 100 mg QD/100 mg BID + Lomustine, 110 mg/m^2|Dose level 1A. Cycle 1: Dasatinib, 100 mg once daily (QD). Cycle 2: Dasatinib, 100 mg twice daily (BID), plus lomustine, 110 mg/m^2.
952337|NCT00948246|B1|Baseline|Easyband|
952338|NCT00948246|P1|Participant Flow|Easyband|
952339|NCT00948246|O1|Outcome|Easyband|
952340|NCT00948246|O1|Outcome|Easyband|
952341|NCT00948246|O1|Outcome|Easyband|
952342|NCT00948246|O1|Outcome|Easyband|
952343|NCT00948246|E1|Reported Event|Easyband|
952344|NCT00948155|B3|Baseline|Total|Total of all reporting groups
952345|NCT00948155|B2|Baseline|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952346|NCT00948155|B1|Baseline|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952347|NCT00948155|P2|Participant Flow|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952348|NCT00948155|P1|Participant Flow|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952349|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
952350|NCT00948155|O1|Outcome|Placebo|21 days using placebo
952351|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
952352|NCT00948155|O1|Outcome|Placebo|21 days using placebo
952353|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
952354|NCT00948155|O1|Outcome|Placebo|21 days using placebo
952355|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
952356|NCT00948155|O1|Outcome|Placebo|21 days using placebo
952357|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
952358|NCT00948155|O1|Outcome|Placebo|21 days using placebo
952359|NCT00948155|O2|Outcome|Varenicline|21 days using Varenicline
952360|NCT00948155|O1|Outcome|Placebo|21 days using placebo
952361|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952362|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952363|NCT00948155|O2|Outcome|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952364|NCT00948155|O1|Outcome|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952455|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
952365|NCT00948155|E2|Reported Event|Varenicline Before Placebo|"Participants will receive standard dosing regimen of Varenicline for 21 days total, followed by 14-day washout and 21 days of placebo. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952366|NCT00948155|E1|Reported Event|Placebo Then Varenicline|"Participants will receive 21 days of placebo, followed by 14-day washout and standard dosing regimen of Varenicline for 21 days total. Standard dosing: 0.5 mg days 1-3; 0.5 mg bid days 4-7; 1.0 mg bid days 8-21.~Varenicline (Chantix) : Standard dosing in pill format: 0.5 mg days 1-3; 0.5 mg bid daily days 4-7; 1.0 mg bid daily days 8-21."
952367|NCT00948090|B3|Baseline|Total|Total of all reporting groups
952415|NCT00947882|P1|Participant Flow|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
952416|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952368|NCT00948090|B2|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952369|NCT00948090|B1|Baseline|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkin's or Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952370|NCT00948090|P4|Participant Flow|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952371|NCT00948090|P3|Participant Flow|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952372|NCT00948090|P2|Participant Flow|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952373|NCT00948090|P1|Participant Flow|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952374|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952375|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952376|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952377|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952378|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952379|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952380|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952381|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952382|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952383|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952543|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952384|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952385|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952567|NCT00947518|B3|Baseline|No Skin Cleansing|No skin application
952386|NCT00948090|O4|Outcome|Non-Hodgkin's Lymphoma (> 65 Years)|Participants with Non-Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952387|NCT00948090|O3|Outcome|Non-Hodgkin's Lymphoma (≤ 65 Years)|Participants with Non-Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952388|NCT00948090|O2|Outcome|Hodgkin's Lymphoma (> 65 Years)|Participants with Hodgkins lymphoma whose age was > 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952389|NCT00948090|O1|Outcome|Hodgkin's Lymphoma (≤ 65 Years)|Participants with Hodgkins lymphoma whose age was ≤ 65 years; who received a test dose of 0.8 mg/kg of IV busulfan between Days −14 and −11; and recieved conditioning regimen of IV busulfan once daily on Days −8 to −5, etoposide on Day −4, and cyclophosphamide on Days −3 and −2, followed by stem cell infusion on Day 0.
952390|NCT00948090|E1|Reported Event|Hodgkin's/Non-Hodgkin's Lymphoma (≤ 65 Years or > 65 Years)|The safety data set consisted of all screened participants who had received at least 1 dose of IV busulfan (including PK test dose).
952391|NCT00948064|B4|Baseline|Total|Total of all reporting groups
952392|NCT00948064|B3|Baseline|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952393|NCT00948064|B2|Baseline|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952394|NCT00948064|B1|Baseline|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
952395|NCT00948064|P3|Participant Flow|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952396|NCT00948064|P2|Participant Flow|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952397|NCT00948064|P1|Participant Flow|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
952398|NCT00948064|O2|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952399|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952400|NCT00948064|O3|Outcome|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952401|NCT00948064|O2|Outcome|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952402|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
952403|NCT00948064|O1|Outcome|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
952404|NCT00948064|E3|Reported Event|Azacitidine, Phase II|Randomized, ARM B: Azacitidine 75 mg/m^2 /day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952405|NCT00948064|E2|Reported Event|Vorinostat With Azacitidine, Phase II|Randomized, ARM A: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three time a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 8 weeks.
952406|NCT00948064|E1|Reported Event|Vorinostat With Azacitidine, Phase I|Open-Label: Azacitidine 75 mg/m^2/day by vein over 15 - 30 minutes daily for 5 days (Days 1 - 5). Vorinostat 200 mg by mouth three times a day with food for 5 days (Days 1 - 5). Courses repeated every 3 to 6 weeks.
952407|NCT00947882|B5|Baseline|Total|Total of all reporting groups
952408|NCT00947882|B4|Baseline|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952409|NCT00947882|B3|Baseline|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952410|NCT00947882|B2|Baseline|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952544|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952411|NCT00947882|B1|Baseline|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952412|NCT00947882|P4|Participant Flow|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952413|NCT00947882|P3|Participant Flow|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952414|NCT00947882|P2|Participant Flow|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952931|NCT00946530|O3|Outcome|Bright Light - Caregiver|Caregiver received Bright Light
952417|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952418|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952419|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
952420|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952421|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952422|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952423|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
952424|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952425|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952426|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952427|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
952428|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952429|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952430|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952431|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
952432|NCT00947882|O4|Outcome|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952433|NCT00947882|O3|Outcome|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952434|NCT00947882|O2|Outcome|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
952435|NCT00947882|O1|Outcome|Placebo|Mannitol 50 mg/mL solution. The dose was administered as a subcutaneous (s.c.) injection in the abdominal region.
952436|NCT00947882|E4|Reported Event|Degarelix 30 mg|Degarelix 30 mg: 30 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952437|NCT00947882|E3|Reported Event|Degarelix 20 mg|Degarelix 20 mg: 20 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952438|NCT00947882|E2|Reported Event|Degarelix 10 mg|Degarelix 10 mg: 10 mg degarelix, 40 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952439|NCT00947882|E1|Reported Event|Placebo|Placebo: Mannitol 50 mg/mL solution. The dose was administered as a s.c. injection in the abdominal region.
952440|NCT00947856|B3|Baseline|Total|Total of all reporting groups
952441|NCT00947856|B2|Baseline|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
952442|NCT00947856|B1|Baseline|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
952443|NCT00947856|P2|Participant Flow|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
952444|NCT00947856|P1|Participant Flow|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
952445|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
952446|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
952447|NCT00947856|O5|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
952448|NCT00947856|O4|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
952449|NCT00947856|O3|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
952450|NCT00947856|O2|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
952451|NCT00947856|O1|Outcome|BV Extension Total|All patients enrolled and treated on the extension arm
952452|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
952453|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
952454|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
952456|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
952457|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
952458|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
952459|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
952460|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
952461|NCT00947856|O1|Outcome|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
952462|NCT00947856|O2|Outcome|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse)
953367|NCT00945100|O1|Outcome|Control|2 hours daily patching
952464|NCT00947856|O4|Outcome|BV Retreatment Total|All patients enrolled and treated on the retreatment arm, including 3 patients retreated more than once
952465|NCT00947856|O3|Outcome|BV Retreatment - Other|Patients with other disease diagnoses enrolled and treated on the retreatment arm
952466|NCT00947856|O2|Outcome|BV Retreatment - ALCL|Patients with anaplastic large cell lymphoma (ALCL) enrolled and treated on the retreatment arm
952467|NCT00947856|O1|Outcome|BV Retreatment - HL|Patients with Hodgkin lymphoma (HL) enrolled and treated on the retreatment arm
952468|NCT00947856|E2|Reported Event|BV Retreatment|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
952469|NCT00947856|E1|Reported Event|BV Extension|Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion
952470|NCT00947791|B3|Baseline|Total|Total of all reporting groups
952471|NCT00947791|B2|Baseline|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952472|NCT00947791|B1|Baseline|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952473|NCT00947791|P2|Participant Flow|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952474|NCT00947791|P1|Participant Flow|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952475|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952476|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952477|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952478|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952479|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952480|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952481|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952482|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952483|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952484|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952485|NCT00947791|O2|Outcome|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952486|NCT00947791|O1|Outcome|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952487|NCT00947791|E2|Reported Event|Midazolam/Ketamine|Participants in this group/condition receive a single IV infusion of midazolam, 0.45 mg/kg and then 2 weeks later received single IV infusion of Ketamine 0.50 mg/kg
952488|NCT00947791|E1|Reported Event|Ketamine/Midazolam|Participants in this group/condition receive a single IV infusion of ketamine, IV 0.5 mg/kg then 2 weeks later receive Midazolam IV 0.45 mg/kg
952489|NCT00947765|B3|Baseline|Total|Total of all reporting groups
952490|NCT00947765|B2|Baseline|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952491|NCT00947765|B1|Baseline|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952492|NCT00947765|P2|Participant Flow|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952493|NCT00947765|P1|Participant Flow|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952494|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952495|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952496|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952497|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952498|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952499|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952500|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952501|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
953428|NCT00944710|B3|Baseline|Total|Total of all reporting groups
952502|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952503|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952504|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952505|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952506|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952507|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952508|NCT00947765|O2|Outcome|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952509|NCT00947765|O1|Outcome|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952510|NCT00947765|E2|Reported Event|Local Corticosteroid Injection Group|This is the control group in whom the commonly used treatment modality-local corticosteroid injection was given at lateral epicondyle site.
952511|NCT00947765|E1|Reported Event|Autologous Blood Injection Group|This is the study group in whom autologous blood injection was injected at lateral epicondylitis site.
952512|NCT00947752|B3|Baseline|Total|Total of all reporting groups
952513|NCT00947752|B2|Baseline|F2 Glatiramer Acetate 20mg/0.5ml|
952514|NCT00947752|B1|Baseline|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
952515|NCT00947752|P2|Participant Flow|F2 Glatiramer Acetate 20mg/0.5ml|
952516|NCT00947752|P1|Participant Flow|F1 Glatiramer Acetate 20mg/1.0ml|
952517|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
952518|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
952519|NCT00947752|O2|Outcome|F2 Glatiramer Acetate 20mg/0.5ml|
952520|NCT00947752|O1|Outcome|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
952521|NCT00947752|E2|Reported Event|F2 Glatiramer Acetate 20mg/0.5ml|
952522|NCT00947752|E1|Reported Event|F1 Glatiramer Acetate (GA) 20mg/1.0ml|
952523|NCT00947661|B3|Baseline|Total|Total of all reporting groups
952524|NCT00947661|B2|Baseline|Reference0912|Reference0912 administered once daily for 12 weeks
952525|NCT00947661|B1|Baseline|SPARC0912|SPARC0912 administered once daily for 12 weeks
952526|NCT00947661|P2|Participant Flow|Reference0912|Reference0912 administered once daily for 12 weeks
952527|NCT00947661|P1|Participant Flow|SPARC0912|SPARC0912 administered once daily for 12 weeks
952528|NCT00947661|O2|Outcome|Reference0912|
952529|NCT00947661|O1|Outcome|SPARC0912|The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit).
952530|NCT00947661|E2|Reported Event|Reference0912|Reference formulation administered once daily for 12 weeks
952531|NCT00947661|E1|Reported Event|SPARC0912|SPARC's formulation administered once daily for 12 weeks
952532|NCT00947544|B1|Baseline|Participants in SO and SE|Patients who completed switch over study and enrolled safety extension study
952533|NCT00947544|P2|Participant Flow|Safety Extension Only|Participants entered the safety extension part of the study only, and received open-label HPN-100 for up to 12 months.
952534|NCT00947544|P1|Participant Flow|Swich Over and Safety Extension|NaPBA was dosed three times daily (TID) with during the first week and the same PBA mole-equivalent dose of HPN-100 during the second week. If there were safety concerns regarding a single-step transition from NaPBA to HPN-100, at the investigator's discretion, the transition could occur in 2 steps such that in the second week, subjects might receive 50% of the PBA equivalent dose as NaPBA and 50% as HPN-100 before receiving 100% of Serial blood samples were collected for PK and blood ammonia assessments after each drug reached steady state, which was achieved approximately 4 days after initiation of 100% NaPBA or HPN100 treatment. After the switch over, participants entered the safety extension part of the study and continued receiving open-label HPN-100 for up to 12 months.
952535|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100 who completed SF-15 at baseline and Month 12
952536|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952537|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952538|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952539|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952540|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952541|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952542|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952549|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952550|NCT00947544|O2|Outcome|NaPBA|Patients treated with NaPBA
952551|NCT00947544|O1|Outcome|HPN-100|Patients treated with HPN-100
952552|NCT00947544|O2|Outcome|Safety Extension (HPN-100)|
952553|NCT00947544|O1|Outcome|Pre-Enrollment (NaPBA)|
952554|NCT00947544|O2|Outcome|NaPBA|NaPBA: Patients treated with NaPBA
952555|NCT00947544|O1|Outcome|HPN-100|HPN-100: Patients treated with HPN-100
952556|NCT00947544|E1|Reported Event|HPN-100|HPN-100: Patient treated with HPN-100
952557|NCT00947531|B3|Baseline|Total|Total of all reporting groups
952558|NCT00947531|B2|Baseline|0.9% Saline Solution|
952559|NCT00947531|B1|Baseline|Cerebrolysin|
952560|NCT00947531|P2|Participant Flow|0.9% Saline Solution|
952561|NCT00947531|P1|Participant Flow|Cerebrolysin|
952562|NCT00947531|O2|Outcome|0.9% Saline Solution|
952568|NCT00947518|B2|Baseline|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
952569|NCT00947518|B1|Baseline|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
952570|NCT00947518|P3|Participant Flow|No Skin Cleansing|No skin application
952571|NCT00947518|P2|Participant Flow|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
952572|NCT00947518|P1|Participant Flow|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
952573|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
952574|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
952575|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
952576|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
952577|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
952578|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
952579|NCT00947518|O3|Outcome|No Skin Cleansing|No skin application
952580|NCT00947518|O2|Outcome|Saline Skin Cleansing|Wiping the skin (except the face) using baby wipes containing normal saline
952581|NCT00947518|O1|Outcome|Chlorhexidine Skin Cleansing|Wiping the skin (except the face) using baby wipes containing 0.25% free chlorhexidine (equivalent to 0.44% chlorhexidine digluconate)
952582|NCT00947505|B3|Baseline|Total|Total of all reporting groups
952583|NCT00947505|B2|Baseline|Control Device|
952584|NCT00947505|B1|Baseline|LLT Device 2009 7 Beam|
952585|NCT00947505|P2|Participant Flow|Control Device|
952586|NCT00947505|P1|Participant Flow|LLT Device 2009 7 Beam|
952587|NCT00947505|O2|Outcome|Control Device|This is the control device emitting white light
952588|NCT00947505|O1|Outcome|LLT Device 2009 7 Beam|This is the active LLLT device
952589|NCT00947505|E2|Reported Event|Control Device|
952590|NCT00947505|E1|Reported Event|LLT Device 2009 7 Beam|
952591|NCT00947427|B3|Baseline|Total|Total of all reporting groups
952592|NCT00947427|B2|Baseline|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
952593|NCT00947427|B1|Baseline|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
952594|NCT00947427|P2|Participant Flow|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
952595|NCT00947427|P1|Participant Flow|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
952596|NCT00947427|O2|Outcome|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
952597|NCT00947427|O1|Outcome|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
952598|NCT00947427|E2|Reported Event|Canakinumab (Anti IL-1beta)|canakinumab (anti IL-1beta): canakinumab subcutaneous injections given at 2.0mg/kg dose on monthly basis for 12 months
952599|NCT00947427|E1|Reported Event|Placebo Injection|Placebo solution (2.0/kg dose) given subcutaneously on monthly basis for 12 months
952600|NCT00947349|B5|Baseline|Total|Total of all reporting groups
952601|NCT00947349|B4|Baseline|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952602|NCT00947349|B3|Baseline|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.). with PegIFN/RBV in TN patients
952603|NCT00947349|B2|Baseline|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952604|NCT00947349|B1|Baseline|Placebo in TN Patients|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952605|NCT00947349|P4|Participant Flow|BI 201335 NA High for Treatment Experienced (TE)|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in treatment experienced (TE) patients.
952606|NCT00947349|P3|Participant Flow|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952607|NCT00947349|P2|Participant Flow|BI 201335 NA Low for Treatment Naive (TN)|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d. (once daily)) with PegIFN/RBV in treatment naive (TN) patients
953350|NCT00945100|P2|Participant Flow|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
952608|NCT00947349|P1|Participant Flow|Placebo in Treatment Naive (TN) Patients|Matching placebo to BI 201335 (Faldaprevir) NA (sodium) with PegIFN/RBV in TN patients
952609|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952610|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952611|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952612|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952613|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952614|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952615|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
952616|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952617|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952618|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952619|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952620|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952621|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952622|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
952623|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952624|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952625|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952626|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952627|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952628|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952629|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952630|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952631|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952632|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
952633|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952634|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952635|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952636|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952637|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952638|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952639|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
952640|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952641|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952642|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952643|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952644|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952645|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952646|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
952647|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952648|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952649|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952650|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
952651|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
953351|NCT00945100|P1|Participant Flow|Control|2 hours daily patching
952652|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952653|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952654|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa- 2a in TN patients
952655|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952656|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952657|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
952658|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
952659|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952660|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952661|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952662|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with RBV and PegIFN alfa-2a in TN patients
952663|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952664|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952665|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952666|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952667|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952668|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952669|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952670|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952671|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952672|NCT00947349|O3|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952673|NCT00947349|O2|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952674|NCT00947349|O1|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952675|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952676|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952677|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
952678|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
952679|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952680|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952681|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
952682|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
952683|NCT00947349|O4|Outcome|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952684|NCT00947349|O3|Outcome|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952685|NCT00947349|O2|Outcome|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
952686|NCT00947349|O1|Outcome|SOC TN Placebo|Standard of care (SOC) for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
952687|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952688|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952689|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952690|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952691|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
953352|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
952692|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952693|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952694|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952695|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952696|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952697|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952698|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952699|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952700|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952701|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952702|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952703|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952704|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952705|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952706|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952707|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952708|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952709|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952710|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952711|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952712|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952713|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952714|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952715|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952716|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952717|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952718|NCT00947349|O1|Outcome|Placebo TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952719|NCT00947349|O4|Outcome|BI 201335 NA High TE|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TE patients
952720|NCT00947349|O3|Outcome|BI 201335 NA High TN|Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV in TN patients
952721|NCT00947349|O2|Outcome|BI 201335 NA Low TN|Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV in TN patients
952722|NCT00947349|O1|Outcome|Placebo in TN|Matching placebo to BI 201335 NA with PegIFN/RBV in TN patients
952723|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952724|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952725|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
952726|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
952727|NCT00947349|O4|Outcome|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952728|NCT00947349|O3|Outcome|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with PegIFN/RBV.
952729|NCT00947349|O2|Outcome|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with PegIFN/RBV.
952730|NCT00947349|O1|Outcome|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with PegIFN/RBV).
952731|NCT00947349|E8|Reported Event|SOC TE 240 mg|Standard of care for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
952732|NCT00947349|E7|Reported Event|SOC TN 240 mg|Standard of care for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
952733|NCT00947349|E6|Reported Event|SOC TN 120 mg|Standard of care for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
952734|NCT00947349|E5|Reported Event|SOC TN Placebo|Standard of care for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
952735|NCT00947349|E4|Reported Event|Triple TE 240 mg|Triple combination therapy for treatment experienced patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
952736|NCT00947349|E3|Reported Event|Triple TN 240 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing high dose of BI 201335 NA (240 mg q.d.) with IFN/RBV.
952737|NCT00947349|E2|Reported Event|Triple TN 120 mg|Triple combination therapy for treatment naive patients- Patients receive a capsule containing low dose of BI 201335 NA (120 mg q.d.) with IFN/RBV.
952738|NCT00947349|E1|Reported Event|Triple TN Placebo|Triple combination therapy for treatment naive patients- Patients receive a capsule containing matching placebo to BI 201335 NA (Placebo with IFN/RBV)
952739|NCT00947310|B4|Baseline|Total|Total of all reporting groups
952740|NCT00947310|B3|Baseline|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
952741|NCT00947310|B2|Baseline|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
952742|NCT00947310|B1|Baseline|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
952743|NCT00947310|P3|Participant Flow|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
952744|NCT00947310|P2|Participant Flow|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
952745|NCT00947310|P1|Participant Flow|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
952746|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
952747|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
952748|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
952749|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
952750|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
952751|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
952752|NCT00947310|O3|Outcome|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
952753|NCT00947310|O2|Outcome|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
952754|NCT00947310|O1|Outcome|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
952755|NCT00947310|E3|Reported Event|C - Long ICD Duration Delay|"Long ICD duration delay~Long delay : Programming of a prolonged delay"
952756|NCT00947310|E2|Reported Event|B - High Rate Cutoff|"High rate cutoff~High rate cutoff : Programming of a high rate cutoff"
952757|NCT00947310|E1|Reported Event|A - Standard ICD Programming|"Standard ICD Programming~Standard ICD programming : Standard ICD programming"
952758|NCT00947297|B1|Baseline|HPN-100|Patients who were treated with HPN-100
952759|NCT00947297|P1|Participant Flow|HPN-100|Patients who were treated with HPN-100
952760|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100~HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
952761|NCT00947297|O1|Outcome|HPN-100|"Patients who were treated with HPN-100~HPN-100: HPN-100 is a triglyceride that has a similar mechanism of action as NaPBA. It is a liquid with minimal taste and odor. Three teaspoons of HPN-100 (~17.4 mL) delivers equivalent of PBA that 40 tablets of NaPBA do."
952762|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
952763|NCT00947297|O1|Outcome|HPN-100|Patients who were treated with HPN-100
952764|NCT00947297|E1|Reported Event|HPN-100|Patients who were treated with HPN-100
952765|NCT00947284|B1|Baseline|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
952766|NCT00947284|P2|Participant Flow|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
952767|NCT00947284|P1|Participant Flow|Women-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
952768|NCT00947284|O1|Outcome|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
952789|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952769|NCT00947284|E1|Reported Event|Men-all Three Combinations|the investigators will use a thermal stimulating device to produce temporary, non-injurious skin sensitivity that subjects will feel as painful. Changes in pain will be measured following the intravenous (i.v.) administration of study drugs. Three drug combinations will be administered, a different one each visit: 1) nalbuphine 5 mg and naloxone 0.4 mg , 2) naloxone 0.4 mg and saline (an inactive solution), nalbuphine 5 mg and saline. These drug combinations will be administered in random order; all subjects will receive all three combinations.
952770|NCT00947271|B5|Baseline|Total|Total of all reporting groups
952771|NCT00947271|B4|Baseline|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952772|NCT00947271|B3|Baseline|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952773|NCT00947271|B2|Baseline|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952774|NCT00947271|B1|Baseline|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952775|NCT00947271|P4|Participant Flow|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952776|NCT00947271|P3|Participant Flow|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952777|NCT00947271|P2|Participant Flow|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952778|NCT00947271|P1|Participant Flow|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952779|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952780|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952781|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952782|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952783|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952784|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952785|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952786|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952787|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952788|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952843|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952790|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952791|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952792|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952847|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952793|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952794|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952795|NCT00947271|O4|Outcome|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952796|NCT00947271|O3|Outcome|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952797|NCT00947271|O2|Outcome|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952798|NCT00947271|O1|Outcome|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952799|NCT00947271|E4|Reported Event|DVD 2 Plus Assessment 2|"Participants will view educational DVD 2 and complete the second version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952800|NCT00947271|E3|Reported Event|DVD 2 Plus Assessment 1|"Participants will view educational DVD 2 and complete the first version of the study assessment.~DVD 2: The second version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident STDs) and improve health"
952801|NCT00947271|E2|Reported Event|DVD 1 Plus Assessment 2|"Participants will view educational DVD 1 and complete the second version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952802|NCT00947271|E1|Reported Event|DVD 1 Plus Assessment 1|"Participants will view educational DVD 1 and complete the first version of the study assessment.~DVD 1: The first version of a 20-minute educational DVD aimed to help adult patients reduce sexual risk behaviors (i.e., number of partners, unprotected sex, incident sexually transmitted diseases [STDs]) and improve health"
952803|NCT00947219|B4|Baseline|Total|Total of all reporting groups
952804|NCT00947219|B3|Baseline|Control Device|Control device emitting LED light
952805|NCT00947219|B2|Baseline|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
952806|NCT00947219|B1|Baseline|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
952807|NCT00947219|P3|Participant Flow|Control Device|Control device emitting LED light
952808|NCT00947219|P2|Participant Flow|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
952809|NCT00947219|P1|Participant Flow|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
952810|NCT00947219|O3|Outcome|Control Device|Control device emitting white light
952811|NCT00947219|O2|Outcome|HairMax LaserComb 2009 9 Beam|the active LLLT Device 2009 9 laser modules
952812|NCT00947219|O1|Outcome|HairMax LaserComb 2009, 12 Beam|The active LLLT Device 2009 with 12 laser modules
952813|NCT00947219|E3|Reported Event|Control Device|Control device emitting LED light
952814|NCT00947219|E2|Reported Event|HairMax LaserComb 2009 9 Beam|LLLT Device 2009 9 Beam, Control Device
952815|NCT00947219|E1|Reported Event|HairMax LaserComb 2009, 12 Beam|LLLT Device 2009 12 Beam, Control Device
952816|NCT00947167|B1|Baseline|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
952817|NCT00947167|P1|Participant Flow|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
952818|NCT00947167|O1|Outcome|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
952819|NCT00947167|O1|Outcome|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
952820|NCT00947167|E1|Reported Event|Pertuzumab and Erlotinib|"pertuzumab: 840 mg, 420 mg, iv~erlotinib: 150 mg, PO"
952821|NCT00947154|B1|Baseline|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
952822|NCT00947154|P1|Participant Flow|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
952823|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
955817|NCT00939120|B3|Baseline|Total|Total of all reporting groups
952824|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
952825|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
952826|NCT00947154|O1|Outcome|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d, which could be reduced to 2 mg/d if the initial dose was not tolerated. Dose was increased by up to 5 mg at intervals of 2 weeks until a maximum target dosage of 15 mg/d was reached at the beginning of week 5. Dose was not increased if the subject showed clinical improvement at a lower dose, defined as a 50% reduction in Massachusetts General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of a further dosing increase. Dose was not increased after week 5; at any point, it could be decreased secondary to side effects.
952827|NCT00947154|E1|Reported Event|Open-label Aripiprazol|Aripiprazole dose of 5 mg/d could be reduced to 2 mg/d if initial dose not tolerated. Dose increased by up to 5 mg q 2 weeks to max dose of 15 mg/d at start of week 5. Dose not increased if subject showed clinical improvement at a lower dose, defined as 50% decrease in Mass General Hospital Hair Pulling Scale (MGHHPS), or was intolerant of dosing increase. Dose not increased after week 5; at any point, it could be decreased for side effects.
952828|NCT00947115|B4|Baseline|Total|Total of all reporting groups
952829|NCT00947115|B3|Baseline|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952830|NCT00947115|B2|Baseline|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952831|NCT00947115|B1|Baseline|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952832|NCT00947115|P3|Participant Flow|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952833|NCT00947115|P2|Participant Flow|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952834|NCT00947115|P1|Participant Flow|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952835|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952836|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952837|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952838|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952839|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952840|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952841|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952842|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952844|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952845|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952846|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952928|NCT00946530|O2|Outcome|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
952848|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952849|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952850|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952851|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952852|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952853|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952854|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952855|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952856|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952857|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952858|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952859|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952860|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952861|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952862|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952863|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952864|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952865|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952866|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952867|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952868|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952920|NCT00946530|B2|Baseline|Dim Light (Control) - AD Patients|AD patients received dim light
952921|NCT00946530|B1|Baseline|Bright Light-AD Patients|AD patients received bright light
952869|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952870|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952871|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952872|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952873|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952874|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952875|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952876|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952877|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952878|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952879|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952880|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952881|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952882|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952883|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952884|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952885|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952886|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952887|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952888|NCT00947115|O1|Outcome|Cervarix 15-45 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952889|NCT00947115|O3|Outcome|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952890|NCT00947115|O2|Outcome|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952891|NCT00947115|O1|Outcome|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952892|NCT00947115|E3|Reported Event|Cervarix 46-55 Years Group|Women, aged 46 to 55 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952893|NCT00947115|E2|Reported Event|Cervarix 26-45 Years Group|Women, aged 26 to 45 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952922|NCT00946530|P4|Participant Flow|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
952894|NCT00947115|E1|Reported Event|Cervarix 15-25 Years Group|Women, aged 15 to 25 at the time of primary vaccination, who were vaccinated with Cervarix intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule in the primary study (NCT00196937)
952895|NCT00946985|B1|Baseline|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
952896|NCT00946985|P1|Participant Flow|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
952897|NCT00946985|O1|Outcome|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
952898|NCT00946985|E1|Reported Event|Paliperidone Palmitate|50, 75, 100, or 150 mg equivalent (eq.) monthly injection
952899|NCT00946920|B3|Baseline|Total|Total of all reporting groups
952929|NCT00946530|O1|Outcome|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
952930|NCT00946530|O4|Outcome|Dim Light (Control) - Caregiver|Caregiver received regular (dim) Light
952900|NCT00946920|B2|Baseline|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952901|NCT00946920|B1|Baseline|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952902|NCT00946920|P2|Participant Flow|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952903|NCT00946920|P1|Participant Flow|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952904|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952905|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952906|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952907|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952908|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952909|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952910|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952911|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952912|NCT00946920|O2|Outcome|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952913|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952914|NCT00946920|O1|Outcome|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952915|NCT00946920|E2|Reported Event|Goserelin Acetate|Goserelin acetate: The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. An initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants).
952916|NCT00946920|E1|Reported Event|Degarelix 240 mg/480 mg|Degarelix: The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. A starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations).
952917|NCT00946530|B5|Baseline|Total|Total of all reporting groups
952918|NCT00946530|B4|Baseline|Dim Light (Control) - Caregivers|Caregivers received dim light
952919|NCT00946530|B3|Baseline|Bright Light - Caregivers|Caregivers received bright light
952923|NCT00946530|P3|Participant Flow|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
952924|NCT00946530|P2|Participant Flow|Dim Light (Control) - AD Patients|AD Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
952925|NCT00946530|P1|Participant Flow|Bright Light - AD Patient|AD Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
952926|NCT00946530|O4|Outcome|Dim Light (Control) - Caregiver|Caregiver Participants received dim light for 30 minutes every day within 30 minutes of arising for 2 weeks
952927|NCT00946530|O3|Outcome|Bright Light - Caregiver|Caregiver Participants received bright light for 30 minutes every day within 30 minutes of arising for 2 weeks
952932|NCT00946530|O2|Outcome|Dim Light (Control) - AD Patients|AD patient received regular (dim) light
952933|NCT00946530|O1|Outcome|Bright Light - AD Patient|AD patient received bright light
952934|NCT00946530|E4|Reported Event|Dim Light (Control) - Caregivers|Caregivers received dim light
952935|NCT00946530|E3|Reported Event|Bright Light - Caregivers|Caregivers received bright light
952936|NCT00946530|E2|Reported Event|Dim Light (Control) - AD Patients|AD patients received dim light
952937|NCT00946530|E1|Reported Event|Bright Light-AD Patients|AD patients received bright light
952938|NCT00946478|B3|Baseline|Total|Total of all reporting groups
952939|NCT00946478|B2|Baseline|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952940|NCT00946478|B1|Baseline|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952941|NCT00946478|P2|Participant Flow|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952942|NCT00946478|P1|Participant Flow|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952943|NCT00946478|O2|Outcome|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952944|NCT00946478|O1|Outcome|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952945|NCT00946478|E2|Reported Event|Vehicle Cream|"Vehicle cream: 20 AD patients will be treated with vehicle cream twice daily for up to 3 weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease9. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952988|NCT00946296|B1|Baseline|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
952989|NCT00946296|P2|Participant Flow|No Treatment|The experimental group receives no treatment.
953267|NCT00945334|P2|Participant Flow|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
952946|NCT00946478|E1|Reported Event|Pimecrolimus|"Pimecrolimus: 20 AD patients will be given pimecrolimus 1% to apply twice daily for up to three weeks on each lesional site predetermined at baseline. AD severity will be evaluated by the Investigator Global Assessment of Disease Activity (IGA). The IGA scale is 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe disease. The patient's AD will be evaluated on Visit 1 (Day -14 to 1), Visit 2 (Day 1), and Visit 3 (Week 21). Lesional target site and non-lesional site will be determined at Visit 1.~Two 2 mm biopsies will be obtained from a target AD lesion and non-lesional sites at Visit 2, and Visit 3 (four biopsies each visit)."
952947|NCT00946348|B3|Baseline|Total|Total of all reporting groups
952948|NCT00946348|B2|Baseline|Cannabis|Cannabis cigarette (3.6% THC)
952949|NCT00946348|B1|Baseline|Dronabinol|Dronabinol 15 mg
952950|NCT00946348|P2|Participant Flow|Cannabis|Cannabis cigarette (3.6% THC)
952951|NCT00946348|P1|Participant Flow|Dronabinol|Dronabinol 15 mg
952952|NCT00946348|O2|Outcome|Cannabis|Cannabis cigarette (3.6% THC)
952953|NCT00946348|O1|Outcome|Dronabinol|Dronabinol 15 mg
952954|NCT00946348|E2|Reported Event|Cannabis|Cannabis cigarette (3.6% THC)
952955|NCT00946348|E1|Reported Event|Dronabinol|Dronabinol 15 mg
952956|NCT00946322|B1|Baseline|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952957|NCT00946322|P1|Participant Flow|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952958|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952959|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952960|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952961|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952962|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952963|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952964|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952965|NCT00946322|O1|Outcome|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952966|NCT00946322|E1|Reported Event|Arm 1: CTAP|Couple-Based Treatment for Alcohol Use Disorders and PTSD: This intervention includes cognitive-behavioral strategies for helping couples to reduce alcohol use and PTSD, while improving relationship functioning.
952967|NCT00946309|B3|Baseline|Total|Total of all reporting groups
952968|NCT00946309|B2|Baseline|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
952969|NCT00946309|B1|Baseline|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952970|NCT00946309|P2|Participant Flow|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
952971|NCT00946309|P1|Participant Flow|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952972|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
952973|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952974|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
952975|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952976|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
952977|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952978|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
952979|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952980|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 6 weeks
952981|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952982|NCT00946309|O2|Outcome|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
952983|NCT00946309|O1|Outcome|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952984|NCT00946309|E2|Reported Event|Placebo|Microcrystalline Cellulose NF (placebo): 250 mg every other day for 5 weeks
952985|NCT00946309|E1|Reported Event|Sulforaphane|High Sulforaphane Extract (Broccoli Sprout Extract): 100 umol sulforaphane, every other day for 5 weeks
952986|NCT00946296|B3|Baseline|Total|Total of all reporting groups
952987|NCT00946296|B2|Baseline|No Treatment|The experimental group receives no treatment.
953019|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
952990|NCT00946296|P1|Participant Flow|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
952991|NCT00946296|O2|Outcome|No Treatment|The experimental group receives no treatment.
952992|NCT00946296|O1|Outcome|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
952993|NCT00946296|E2|Reported Event|No Treatment|The experimental group receives no treatment.
952994|NCT00946296|E1|Reported Event|Potassium Iodide|"8 drops of Potassium Iodide in a glass of water, by mouth, daily for 7 days prior to operation.~Potassium Iodide: 8 drops of Potassium Iodide in a glass of water taken daily for 7 days prior to thyroidectomy. This is the current standard of care."
952995|NCT00946114|B3|Baseline|Total|Total of all reporting groups
952996|NCT00946114|B2|Baseline|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
957188|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
952997|NCT00946114|B1|Baseline|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
952998|NCT00946114|P2|Participant Flow|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
952999|NCT00946114|P1|Participant Flow|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
953000|NCT00946114|O2|Outcome|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
953001|NCT00946114|O1|Outcome|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
953002|NCT00946114|E2|Reported Event|Sildenafil 240 mg|Sildenafil 80 mg TID (3 times daily); subjects who completed study A1481142
953003|NCT00946114|E1|Reported Event|Sildenafil 60 mg|Sildenafil 20 mg TID (3 times daily); eligible adult subjects with PAH (pulmonary arterial hypertension)
953004|NCT00946101|B3|Baseline|Total|Total of all reporting groups
953005|NCT00946101|B2|Baseline|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953006|NCT00946101|B1|Baseline|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953007|NCT00946101|P2|Participant Flow|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953008|NCT00946101|P1|Participant Flow|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953009|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953010|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953011|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953012|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953013|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953014|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953015|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953016|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953017|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953018|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953020|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953021|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953022|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953023|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953024|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953025|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953026|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953027|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953028|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953029|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953030|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953031|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953032|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953033|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953034|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953035|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953036|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953037|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953038|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953039|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953040|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953041|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953042|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953043|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953044|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953045|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953046|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953047|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953048|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953049|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953050|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953051|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953052|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953053|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953054|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953055|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953056|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953057|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953058|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953059|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953060|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953061|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953131|NCT00945906|P1|Participant Flow|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953062|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953063|NCT00946101|O2|Outcome|Placebo|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers. Subjects were to receive a total of 2 doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953064|NCT00946101|O1|Outcome|H1N1 Monovalent Influenza Vaccine|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009. Subjects were to receive two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953065|NCT00946101|E6|Reported Event|Placebo Days 58-209|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
953835|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
953066|NCT00946101|E5|Reported Event|H1N1 Monovalent Vaccine Days 58-209|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
953067|NCT00946101|E4|Reported Event|Placebo Days 29-57|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers.
953068|NCT00946101|E3|Reported Event|H1N1 Monvalent Vaccine Days 29-57|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
953069|NCT00946101|E2|Reported Event|Placebo Days 1-28|Placebo - 0.5 mL of sucrose-phosphate buffer contained in intranasal sprayers
953070|NCT00946101|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-28|MEDI3414- Monovalent vaccine supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type A/California/07/2009.
953071|NCT00946088|B3|Baseline|Total|Total of all reporting groups
953072|NCT00946088|B2|Baseline|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
953073|NCT00946088|B1|Baseline|Progesterone|Progesterone 400 mg per vagina qhs.
953074|NCT00946088|P2|Participant Flow|Polyethylene Glycol 400 Distearate & Hydrogenated Vegetable oi|Polyethylene glycol 400 distearate & hydrogenated vegetable oil
953075|NCT00946088|P1|Participant Flow|Progesterone|Progesterone 400 mg per vagina qhs.
953076|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953077|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953078|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953079|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953080|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953081|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953082|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953083|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953084|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953085|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953086|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953087|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953088|NCT00946088|O2|Outcome|Polyethylene & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953089|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953090|NCT00946088|O2|Outcome|Polyethylene Glycol & Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953091|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953092|NCT00946088|O2|Outcome|Polyethylene Glycol&Hydrogenated Vegetable Oil|Polyethylene glycol 400 distearate & hydrogenated vegetable oil per vagina
953093|NCT00946088|O1|Outcome|Progesterone|Progesterone 400 mg per vagina qhs.
953094|NCT00946088|E2|Reported Event|Placebo Comparator: Polyethylene Glycol&Hydrogenated Vegetab|Placebo Comparator:Polyethylene glycol&hydrogenated vegetable oil per vagina.
953095|NCT00946088|E1|Reported Event|Active Comparator: Progesterone|Progesterone 400mg per vagina qhs.
953096|NCT00945958|B1|Baseline|SPARC0913|Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler.
953097|NCT00945958|P1|Participant Flow|SPARC0913|
953098|NCT00945958|O1|Outcome|SPARC0913|SPARC0913: One drop of SPARC0913 in affected eye once daily for 24 weeks
953099|NCT00945958|O1|Outcome|SPARC|The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms.
953100|NCT00945958|E1|Reported Event|SPARC0913|From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated
953101|NCT00945945|B3|Baseline|Total|Total of all reporting groups
953102|NCT00945945|B2|Baseline|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953353|NCT00945100|O1|Outcome|Control|2 hours daily patching
953103|NCT00945945|B1|Baseline|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953138|NCT00945906|E1|Reported Event|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953139|NCT00945893|B3|Baseline|Total|Total of all reporting groups
953364|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953104|NCT00945945|P2|Participant Flow|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953105|NCT00945945|P1|Participant Flow|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953106|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953107|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953108|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953109|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953110|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953111|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953132|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953268|NCT00945334|P1|Participant Flow|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
953112|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953365|NCT00945100|O1|Outcome|Control|2 hours daily patching
953113|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953114|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953115|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953116|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953117|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953118|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953119|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953120|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953133|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953134|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953121|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953122|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953123|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953124|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953125|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953126|NCT00945945|O2|Outcome|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953127|NCT00945945|O1|Outcome|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953128|NCT00945945|E2|Reported Event|PLA-DLX60|Per the protocol, patients randomized to the placebo group were to receive placebo for the entire 13-week acute treatment period. Patients were to start on placebo for the first week, then continue on placebo for the following 12 weeks. However, due to a study drug labeling error, patients in this group received placebo for the initial 1-week, but received 60 mg QD of duloxetine instead of receiving placebo for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as PLA-DLX60 throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive placebo that week, and that did occur per protocol.
953129|NCT00945945|E1|Reported Event|DLX30-PLA|Per the protocol, patients randomized to the duloxetine group were to receive duloxetine for the entire 13-week acute treatment period. Patients were to start at a 30 mg daily (QD) dose of duloxetine for 1 week, then increase to 60 mg QD of duloxetine for the following 12 weeks. However, due to a study drug labeling error, patients randomized to this group received 30 mg of duloxetine for the initial 1-week, but received placebo instead of receiving 60 mg QD of duloxetine for the next 12 weeks. The resulting unintended, mixed treatment group was labeled as DLX30-PLA throughout this document. Per protocol, the last week of the study (week 14) was intended to be a 1-week taper period. Patients in this treatment group were to receive 30 mg QD of duloxetine during that week, and that did occur per protocol.
953130|NCT00945906|B1|Baseline|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953263|NCT00945477|E1|Reported Event|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
953264|NCT00945334|B3|Baseline|Total|Total of all reporting groups
953135|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953136|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953137|NCT00945906|O1|Outcome|FXIII|Subjects were administered FXIII Concentrate (Human) by intravenous (IV) infusion approximately every 28 days to maintain a trough FXIII level of approximately 5 to 20%.
953366|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953140|NCT00945893|B2|Baseline|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953141|NCT00945893|B1|Baseline|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953142|NCT00945893|P2|Participant Flow|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953143|NCT00945893|P1|Participant Flow|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray administered approximately 28 days apart on Days 1 and 29.
953144|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953145|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953146|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953147|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953148|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953149|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953150|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953151|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953152|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953153|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953154|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953155|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953156|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953157|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953347|NCT00945100|B3|Baseline|Total|Total of all reporting groups
953158|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953159|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953200|NCT00945893|E6|Reported Event|Placebo Days 58-209|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953160|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953161|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953162|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953163|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953164|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953165|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953166|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953167|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953168|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953169|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953170|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953171|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953172|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953173|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953174|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953175|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953176|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953177|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953265|NCT00945334|B2|Baseline|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
953348|NCT00945100|B2|Baseline|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953178|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953179|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953180|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953181|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953182|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953183|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953184|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953185|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953186|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953187|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953188|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953189|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953190|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953191|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953192|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953193|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953194|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953195|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953196|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953197|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953266|NCT00945334|B1|Baseline|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
953349|NCT00945100|B1|Baseline|Control|2 hours daily patching
953552|NCT00944125|O1|Outcome|Dual Site LV Pacing|
953198|NCT00945893|O2|Outcome|MEDI3414 [Influenza A (H1N1) Vaccine]|MEDI3414 - Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of live, attenuated influenza virus reassortant A/California/7/2009 strain that was propagated in chicken eggs. H1N1 monovalent influenza vaccine (MEDI3414) contained no preservatives and no adjuvants.
953199|NCT00945893|O1|Outcome|Placebo|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953201|NCT00945893|E5|Reported Event|H1N1 Monovalent Days 58-209|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953202|NCT00945893|E4|Reported Event|Placebo Days 29-57|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953203|NCT00945893|E3|Reported Event|H1N1 Monovalent Vaccine Days 29-57|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953204|NCT00945893|E2|Reported Event|Placebo Days 1-15|Placebo (intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer). Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953205|NCT00945893|E1|Reported Event|H1N1 Monovalent Vaccine Days 1-15|A/California/7/2009 strain of the live, attenuated influenza virus reassortant 10^7 FFU that was propagated in chicken eggs. MEDI3414 contained no preservatives and no adjuvants. Subjects received two doses by intranasal spray; each dose was administered approximately 28 days apart on Days 1 and 29.
953206|NCT00945854|B3|Baseline|Total|Total of all reporting groups
953207|NCT00945854|B2|Baseline|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953208|NCT00945854|B1|Baseline|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953209|NCT00945854|P2|Participant Flow|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953210|NCT00945854|P1|Participant Flow|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953211|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953212|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
954841|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
953213|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953272|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
953214|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953215|NCT00945854|O2|Outcome|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953216|NCT00945854|O1|Outcome|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953217|NCT00945854|E2|Reported Event|Refined Cereal Diet|"Treatment with a diet based on refined cereals and foods with high glycemic index~Refined cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on refined cereals and foods with high glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953218|NCT00945854|E1|Reported Event|Wholegrain Cereal Diet|"Treatment with a diet based on wholegrain cereals and foods with low glycemic index~Wholegrain cereal diet: Thirty subjects with metabolic syndrome, after an initial run-in period of 4 weeks, during which they stabilise their own diet and other lifestyle habits, are assigned to a diet based on wholegrain cereals and foods with low glycemic index for a period of 12 weeks. Before and after the dietary treatment, a frequently samples intravenous glucose tolerance is carried out to measure the effects of the intervention on glucose and insulin metabolism. At beginning and at the end of intervention, the subjects consume also a standard test meal to evaluate the postprandial response of glucose, insulin, lipids, oxidative parameters and inflammatory molecules."
953219|NCT00945815|B1|Baseline|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
953220|NCT00945815|P1|Participant Flow|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
953221|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
953222|NCT00945815|O1|Outcome|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
953223|NCT00945815|E1|Reported Event|Ara-C + Clofarabine + Epratuzumab|Ara-C 1 g/m2/d IV Days 1-5, clofarabine 40 mg/m2/d IV Days 2-6, epratuzumab 360 mg/m2/d IV Days 7, 14, 21, 28, acetaminophen 650 mg/d PO Days 7, 14, 21, 28, dephenhydramine 50 mg/d IV Days 7, 14, 21, 28, IT methotrexate 12 mg IT at least 1 wk apart during induction. 1 cycle=28 days. Maximum of one cycle.
953224|NCT00945750|B7|Baseline|Total|Total of all reporting groups
953225|NCT00945750|B6|Baseline|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
953226|NCT00945750|B5|Baseline|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
954842|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
953227|NCT00945750|B4|Baseline|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
953228|NCT00945750|B3|Baseline|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
953229|NCT00945750|B2|Baseline|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
953230|NCT00945750|B1|Baseline|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
953231|NCT00945750|P6|Participant Flow|CT With Water / CT Without Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water.
953232|NCT00945750|P5|Participant Flow|CT Without Water / FCT With Water / CT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
953233|NCT00945750|P4|Participant Flow|FCT With Water / CT With Water / CT Without Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
953234|NCT00945750|P3|Participant Flow|CT With Water / FCT With Water / CT Without Water|Participants received famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water.
953235|NCT00945750|P2|Participant Flow|CT Without Water / CT With Water / FCT With Water|Participants received famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg FCT as a single dosewith 120 mL of water.
953236|NCT00945750|P1|Participant Flow|FCT With Water / CT Without Water / CT With Water|Participants received famotidine 20 mg FCT as a single dose with 120 mL of water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose without water, followed by a 5- to 7-day washout, followed by famotidine 20 mg CT as a single dose with 120 mL of water.
953237|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
953238|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
953239|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
953240|NCT00945750|O1|Outcome|Famotidine 20 mg CT With Water|Famotidine 20 mg CT with 120 mL of water
953241|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
953242|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
953243|NCT00945750|O2|Outcome|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT with 120 mL of water
953244|NCT00945750|O1|Outcome|Famotidine 20 mg CT Without Water|Famotidine 20 mg CT without water
953245|NCT00945750|E3|Reported Event|Famotidine 20 mg CT With Water|Famotidine 20 mg chewable tablet with 120 mL of water
953246|NCT00945750|E2|Reported Event|Famotidine 20 mg CT Without Water|Famotidine 20 mg Chewable Tablet without water
953247|NCT00945750|E1|Reported Event|Famotidine 20 mg FCT With Water|Famotidine 20 mg FCT (film-coated tablet) with 120 mL of water
953248|NCT00945555|B1|Baseline|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953249|NCT00945555|P1|Participant Flow|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953250|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953251|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953252|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953253|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953254|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953255|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953256|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953257|NCT00945555|O1|Outcome|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953258|NCT00945555|E1|Reported Event|All Participants|Participants with febrile neutropenia who received treatment as determined by the physician
953259|NCT00945477|B1|Baseline|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
953260|NCT00945477|P1|Participant Flow|Advanced Prostate Cancer, Treatment, Pazopanib|"Pazopanib~Pazopanib (GW786034) : Pazopanib 800 mg daily x 12 weeks"
953261|NCT00945477|O1|Outcome|Participants With Adverse Events 800mg Pazopanib|Adverse events for all participants, all grades
953262|NCT00945477|O1|Outcome|Pazopanib 800mg Daily by Mouth|Response rate at 12 weeks
954843|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
953269|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
953270|NCT00945334|O1|Outcome|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
953271|NCT00945334|O2|Outcome|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
953362|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953273|NCT00945334|E2|Reported Event|Group 2|"Group 2 will receive neomycin (500 mg po bid) and rifaximin (550mg po tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Rifaximin: 550 mg po tid"
953274|NCT00945334|E1|Reported Event|Group 1|"Group 1 will receive neomycin (500 mg po bid) and placebo (tid) for 14 days~Neomycin: 500 mg po bid for 14 days~Placebo: placebo for 14 days tid"
953275|NCT00945321|B1|Baseline|All Participants|All randomized patients.
953276|NCT00945321|P6|Participant Flow|C/B/A/E|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
953277|NCT00945321|P5|Participant Flow|B/A/C/E|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
953278|NCT00945321|P4|Participant Flow|A/C/B/E|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment E: 185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
953279|NCT00945321|P3|Participant Flow|C/A/B/D|"Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
953280|NCT00945321|P2|Participant Flow|B/C/A/D|"Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
953281|NCT00945321|P1|Participant Flow|A/B/C/D|"Treatment A: 165 mg aprepitant Final Market Composition capsule in the fasted state/ Treatment B: 185 mg aprepitant Final Market Composition capsule in the fasted state/Treatment C: 150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state/ Treatment D: 165 mg aprepitant Final Market Composition capsule in the fed state.~(The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
953282|NCT00945321|O6|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
953283|NCT00945321|O5|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
953284|NCT00945321|O4|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
953285|NCT00945321|O3|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
953286|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
953287|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
953288|NCT00945321|O7|Outcome|185 mg Aprepitant (High-Fat)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
953289|NCT00945321|O6|Outcome|185 mg Aprepitant (Light)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
953290|NCT00945321|O5|Outcome|165 mg Aprepitant (High-Fat)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The (12) subjects in this treatment group received a standard high-fat breakfast.)"
953291|NCT00945321|O4|Outcome|165 mg Aprepitant (Light)|"165 mg aprepitant Final Market Composition capsule in the fed state.~(The subjects (9) in this treatment group received a standard light breakfast.)"
953292|NCT00945321|O3|Outcome|150 mg Fosaprepitant Dimeglumine (Fasted State)|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
953293|NCT00945321|O2|Outcome|185 mg Aprepitant (Fasted State)|185 mg aprepitant Final Market Composition capsule in the fasted state
953294|NCT00945321|O1|Outcome|165 mg Aprepitant (Fasted State)|165 mg aprepitant Final Market Composition capsule in the fasted state
953295|NCT00945321|E5|Reported Event|185 mg Aprepitant (Fed State)|"185 mg aprepitant Final Market Composition capsule in the fed state.~(The first 11 subjects in this treatment group received a standard high-fat breakfast. The rest of the subjects (9) in this treatment group received a standard light breakfast)"
953296|NCT00945321|E4|Reported Event|165 mg Aprepitant (Fed State)|"165 mg aprepitant Final Market Composition capsule in the fed~state. (The first 12 subjects in this treatment group received a standard high-fat breakfast. The rest of the~subjects (9) in this treatment group received a standard light breakfast)"
953297|NCT00945321|E3|Reported Event|150 mg Fosaprepitant Dimeglumine|150 mg fosaprepitant dimeglumine intravenous infusion in the fasted state
953298|NCT00945321|E2|Reported Event|185 mg Aprepitant|185 mg aprepitant Final Market Composition capsule in the fasted state
953299|NCT00945321|E1|Reported Event|165 mg Aprepitant|165 mg aprepitant Final Market Composition capsule in the fasted state
953300|NCT00945295|B3|Baseline|Total|Total of all reporting groups
953301|NCT00945295|B2|Baseline|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953302|NCT00945295|B1|Baseline|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953303|NCT00945295|P2|Participant Flow|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953304|NCT00945295|P1|Participant Flow|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953305|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953306|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953307|NCT00945295|O2|Outcome|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953308|NCT00945295|O1|Outcome|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953309|NCT00945295|E2|Reported Event|Cohort #2|"Cohort 2 will receive BoNT-A alone~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953310|NCT00945295|E1|Reported Event|Cohort #1|"Cohort 1 will receive BoNT-A plus rehabilitation therapy for the duration of the study (for up to 2 injections of BoNT-A).~Rehabilitation Therapy : Rehabilitation therapy~Botulinum toxin type A, BoNT-A : Participants will receive IM injections of BoNT-A between 200 and 400 Units with the total dose not to exceed 6 U / kg. The primary targets for BoNT-A injection are the wrist and finger flexor muscles (flexor carpi radialis, flexor carpi ulnaris, flexor digitorum profundus, flexor digitorum superficialis)."
953311|NCT00945256|B6|Baseline|Total|Total of all reporting groups
953312|NCT00945256|B5|Baseline|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
953313|NCT00945256|B4|Baseline|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953314|NCT00945256|B3|Baseline|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953315|NCT00945256|B2|Baseline|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
953316|NCT00945256|B1|Baseline|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
953317|NCT00945256|P5|Participant Flow|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 gram amino acid drink taken orally.
953318|NCT00945256|P4|Participant Flow|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953319|NCT00945256|P3|Participant Flow|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953320|NCT00945256|P2|Participant Flow|Elderly Aerobic Exercise|45 minutes of treadmill walking at 40% VO2 peak.
953321|NCT00945256|P1|Participant Flow|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak
953322|NCT00945256|O5|Outcome|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and a 7.5g amino acid drink taken orally.
953323|NCT00945256|O4|Outcome|Elderly Sodium Nitroprusside (SNP)|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953324|NCT00945256|O3|Outcome|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given in a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953325|NCT00945256|O2|Outcome|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
953326|NCT00945256|O1|Outcome|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
953327|NCT00945256|E5|Reported Event|Elderly Sodium Nitroprusside and Amino Acid Drink|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min and 7.5 grams of amino acids taken orally.
953328|NCT00945256|E4|Reported Event|Elderly Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953329|NCT00945256|E3|Reported Event|Young Sodium Nitroprusside|Sodium Nitroprusside (Nitropress) given as a constant infusion for 180 minutes at a rate of 0.114 ug/kg/min.
953330|NCT00945256|E2|Reported Event|Elderly Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
953331|NCT00945256|E1|Reported Event|Young Aerobic Exercise|45 minutes of treadmill walking completed at 40% VO2 peak.
953332|NCT00945243|B1|Baseline|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
953333|NCT00945243|P1|Participant Flow|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
953334|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
953335|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
953336|NCT00945243|O1|Outcome|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
953337|NCT00945243|E1|Reported Event|Treatment|"Treatment of cervical DDD with the Zero-P device~ACDF: The Zero-P PEEK is a stand-alone device intended for use in cervical interbody fusion. The device consists of a plate and a spacer with four rigid screws to provide similar stability to a traditional cervical plate and interbody spacer. It is intended for use in skeletally mature patients with symptomatic cervical disc disease (SCDD) with accompanying radicular symptoms, at one level from C3 to C7."
953338|NCT00945139|B1|Baseline|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
953339|NCT00945139|P1|Participant Flow|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
953340|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
953341|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Open label study of Doxil given as 30 mg/m2 every three weeks by itself in cycle 1, and then followed by Avastin 15 mg/kg on cycle 2 and every cycle thereafter until disease progression (Progression-Free Survival determination) or withdrawal for other causes (unacceptable toxicity, patient preference). Patients undergoing PK determinations will have the dose of Avastin on cycle 2 given 24 hours after Doxil.
953342|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
953343|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
953344|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
953345|NCT00945139|O1|Outcome|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
953346|NCT00945139|E1|Reported Event|Doxil (PLD) + Avastin (Bevacizumab)|Treatment was administered every 3 weeks (bevacizumab 15 mg/kg beginning on cycle 2 and PLD 30 mg/m2).
953354|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953355|NCT00945100|O1|Outcome|Control|2 hours daily patching
953356|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953357|NCT00945100|O1|Outcome|Control|2 hours daily patching
953358|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953359|NCT00945100|O1|Outcome|Control|2 hours daily patching
953360|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953361|NCT00945100|O1|Outcome|Control|2 hours daily patching
953368|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953369|NCT00945100|O1|Outcome|Control|2 hours daily patching
953370|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953371|NCT00945100|O1|Outcome|Control|2 hours daily patching
953372|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953373|NCT00945100|O1|Outcome|Control|2 hours daily patching
953374|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953375|NCT00945100|O1|Outcome|Control|2 hours daily patching
953376|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953377|NCT00945100|O1|Outcome|Control|2 hours daily patching
953378|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953379|NCT00945100|O1|Outcome|Control|2 hours daily patching
953380|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953381|NCT00945100|O1|Outcome|Control|2 hours daily patching
953382|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953383|NCT00945100|O1|Outcome|Control|2 hours daily patching
953384|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953385|NCT00945100|O1|Outcome|Control|2 hours daily patching
953386|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953387|NCT00945100|O1|Outcome|Control|2 hours daily patching
953388|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953389|NCT00945100|O1|Outcome|Control|2 hours daily patching
953390|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953391|NCT00945100|O1|Outcome|Control|2 hours daily patching
953392|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953393|NCT00945100|O1|Outcome|Control|2 hours daily patching
953394|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953395|NCT00945100|O1|Outcome|Control|2 hours daily patching
953396|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953397|NCT00945100|O1|Outcome|Control|2 hours daily patching
953398|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953399|NCT00945100|O1|Outcome|Control|2 hours daily patching
953400|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953401|NCT00945100|O1|Outcome|Control|2 hours daily patching
953402|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953403|NCT00945100|O1|Outcome|Control|2 hours daily patching
953404|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953405|NCT00945100|O1|Outcome|Control|2 hours daily patching
953406|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953407|NCT00945100|O1|Outcome|Control|2 hours daily patching
953408|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953409|NCT00945100|O1|Outcome|Control|2 hours daily patching
953410|NCT00945100|O2|Outcome|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953411|NCT00945100|O1|Outcome|Control|2 hours daily patching
953412|NCT00945100|E2|Reported Event|Intensified Treatment|42 hours per week of patching (averaging 6 hours daily)
953413|NCT00945100|E1|Reported Event|Control|2 hours daily patching
953414|NCT00945035|B1|Baseline|All Participants in Study|
953415|NCT00945035|P2|Participant Flow|Etoricoxib URC Then Etoricoxib FMI|URC Formulation (30%), Unmilled Roller Compaction/ FMI Formulation (20%), Final Market Image
953416|NCT00945035|P1|Participant Flow|Etoricoxib FMI Then Etoricoxib URC|FMI Formulation (20%), Final Market Image/ URC Formulation (30%), Unmilled Roller Compaction
953417|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
953418|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
953419|NCT00945035|O2|Outcome|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
953420|NCT00945035|O1|Outcome|Etoricoxib FMI|FMI Formulation (20%), Final Market Image.
953421|NCT00945035|E2|Reported Event|Etoricoxib URC|URC Formulation (30%), Unmilled Roller Compaction
954844|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
953422|NCT00945035|E1|Reported Event|Etoricoxib FMI|FMI Formulation (20%), Final Market Image
953423|NCT00944749|B1|Baseline|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
953424|NCT00944749|P1|Participant Flow|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
953425|NCT00944749|O1|Outcome|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
953426|NCT00944749|O1|Outcome|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
953427|NCT00944749|E1|Reported Event|Single Arm|Subjects were given a second course of immunosuppression with h-ATG/CsA in subjects’ refractory to or with a suboptimal response to a course of r-ATG/CsA or cyclophosphamide at least 3 months post-treatment
953429|NCT00944710|B2|Baseline|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953430|NCT00944710|B1|Baseline|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953431|NCT00944710|P2|Participant Flow|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953432|NCT00944710|P1|Participant Flow|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953433|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953434|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953435|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953436|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953437|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953438|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953439|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953440|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953441|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953442|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953443|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953444|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953445|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953446|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953447|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953448|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953449|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953450|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953451|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953452|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953453|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953454|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953455|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953456|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953457|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953458|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953459|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953460|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953461|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953462|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953463|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953464|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953465|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953466|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953467|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953468|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953469|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953470|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953471|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953472|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953473|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953474|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953475|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953476|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953477|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953478|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953836|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
953479|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953480|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953481|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953482|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953483|NCT00944710|O2|Outcome|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953484|NCT00944710|O1|Outcome|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953485|NCT00944710|E2|Reported Event|Intensified Treatment|"Weekend atropine 1% with plano lens over the sound eye~Atropine: Weekend atropine 1%~Plano lens: plano lens over the sound eye"
953486|NCT00944710|E1|Reported Event|Control|"Weekend atropine 1%~Atropine: Weekend atropine 1%"
953487|NCT00944697|B3|Baseline|Total|Total of all reporting groups
953488|NCT00944697|B2|Baseline|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
953489|NCT00944697|B1|Baseline|Placebo Tablets|A placebo tablet to match the active reference treatment
953490|NCT00944697|P2|Participant Flow|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
953491|NCT00944697|P1|Participant Flow|Placebo Tablets|A placebo tablet to match the active reference treatment
953492|NCT00944697|O2|Outcome|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
953493|NCT00944697|O1|Outcome|Placebo Tablets|A placebo tablet to match the active reference treatment
953494|NCT00944697|E2|Reported Event|OXN PR Tablet|Oxycodone Naloxone Prolonged Release (OXN PR) tablets
953495|NCT00944697|E1|Reported Event|Placebo Tablets|A placebo tablet to match the active reference treatment
953496|NCT00944671|B7|Baseline|Total|Total of all reporting groups
953497|NCT00944671|B6|Baseline|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
953498|NCT00944671|B5|Baseline|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
953499|NCT00944671|B4|Baseline|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
953500|NCT00944671|B3|Baseline|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
953501|NCT00944671|B2|Baseline|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
953502|NCT00944671|B1|Baseline|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
953503|NCT00944671|P6|Participant Flow|EZ Chew With Water/EZ Chew Without Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water
953504|NCT00944671|P5|Participant Flow|EZ Chew Without Water/Famotidine With Water/EZ Chew With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water
953505|NCT00944671|P4|Participant Flow|Famotidinewith Water/EZ Chew With Water/EZ Chew Without Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
953506|NCT00944671|P3|Participant Flow|EZ Chew With Water/Famotidine With Water/EZ Chew Without Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water
953507|NCT00944671|P2|Participant Flow|EZ Chew Without Water/EZ Chew With Water/Famotidine With Water|Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew tablet with 120 mL of water, Famotidine/antacid combination tablet with 120 mL of water
953508|NCT00944671|P1|Participant Flow|Famotidine With Water/EZ Chew Without Water/EZ Chew With Water|Famotidine/antacid combination tablet with 120 mL of water, Famotidine/antacid combination EZ Chew tablet without water, Famotidine/antacid combination EZ Chew with 120 mL of water
953509|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
954845|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
953510|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
953511|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
953512|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet With Water|
953513|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
953514|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
953515|NCT00944671|O2|Outcome|Famotidine/Antacid Combination Tablet With Water|
953516|NCT00944671|O1|Outcome|Famotidine/Antacid Combination EZ Chew Tablet Without Water|
953517|NCT00944671|E3|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet With Water|Famotidine/antacid combination EZ Chew tablet with 120 mL of water
953518|NCT00944671|E2|Reported Event|Famotidine/Antacid Combination EZ Chew Tablet Without Water|Famotidine/antacid combination EZ Chew tablet without water
953519|NCT00944671|E1|Reported Event|Famotidine/Antacid Combination Tablet With Water|Famotidine/antacid combination tablet with 120 mL of water
953520|NCT00944645|B1|Baseline|All Participants|Includes all participants from Both treatment groups; MK0524A Phase III tablet and MK0524A New Site tablet
954037|NCT00943761|B3|Baseline|Total|Total of all reporting groups
953521|NCT00944645|P2|Participant Flow|MK0524A New Site Tablet Then MK0524A Phase III Tablet|MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)/ MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)
953522|NCT00944645|P1|Participant Flow|MK0524A Phase III Tablet Then MK0524A New Site Tablet|MK0524A Phase III tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) Phase III tablet (Source 1)/MK0524A New Site tablet: MK0524A (1000 mg ER Niacin/20 mg MK0524) tablet from new manufacturing site (Source 2)
953523|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
953524|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
953525|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
953526|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
953527|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
953528|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
953529|NCT00944645|O2|Outcome|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
953530|NCT00944645|O1|Outcome|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
953531|NCT00944645|E2|Reported Event|MK0524A New Site Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) tablet from new manufacturing site (Source 2)
953532|NCT00944645|E1|Reported Event|MK0524A Phase III Tablet|MK0524A (1000 mg ER Niacin/20 mg laropiprant) Phase III tablet (Source 1)
953533|NCT00944450|B1|Baseline|All Participants|
953534|NCT00944450|P2|Participant Flow|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
953535|NCT00944450|P1|Participant Flow|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
953536|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
953537|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
953538|NCT00944450|O2|Outcome|100 mg MK0431 Monohydrate|100 mg MK0431 monohydrate (Phase III/FMI) formulation administered as a single dose.
953539|NCT00944450|O1|Outcome|100 mg MK0431 Anhydrous|100 mg MK0431 anhydrous (Phase IIB) formulation administered as a single dose.
953540|NCT00944450|E2|Reported Event|100 mg MK0431 Monohydrate Then 100 mg MK0431 Anhydrous|100 mg MK0431 monohydrate (Phase III/FMI formulation) then 100 mg MK0431 anhydrous (Phase IIB formulation)
953541|NCT00944450|E1|Reported Event|100 mg MK0431 Anhydrous Then 100 mg MK0431 Monohydrate|Single dose sitagliptin 100 mg tablets [monohydrate Final Market Image (FMI) form] in one of two treatment periods.
953542|NCT00944229|B1|Baseline|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
953543|NCT00944229|P1|Participant Flow|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
953544|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
953545|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
953546|NCT00944229|O1|Outcome|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
953547|NCT00944229|E1|Reported Event|LOVAZA or Placebo|Data per arm is not available. Columbia will never have access to this data.
953548|NCT00944125|B1|Baseline|All Study Participants|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Arm A: Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months. Randomized to Arm B: Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
953549|NCT00944125|P2|Participant Flow|BiV Pacing First, Then Dual Site LV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
953550|NCT00944125|P1|Participant Flow|Dual Site LV Pacing First, Then BiV Pacing, Then Physician Dis|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
953551|NCT00944125|O2|Outcome|BiV Pacing|
953553|NCT00944125|E2|Reported Event|BiV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to standard BiV pacing for three months then crossed over to Dual LV pacing for three months, then programmed per physician discretion for the remainder of the study."
953554|NCT00944125|E1|Reported Event|Dual Site LV Pacing|"Prospective randomized blinded crossover study of patients meeting current CRT-D indication implanted with Dual LV pacing leads compared to BiV pacing.~Randomized to Dual Site LV Pacing for three months then crossed over to standard BIV pacing for three months then programmed per physician discretion for the remainder three months."
953555|NCT00944073|B3|Baseline|Total|Total of all reporting groups
953556|NCT00944073|B2|Baseline|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953557|NCT00944073|B1|Baseline|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953558|NCT00944073|P2|Participant Flow|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953559|NCT00944073|P1|Participant Flow|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953560|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953561|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953562|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953563|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953564|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953565|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953566|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953567|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953568|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953569|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953570|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953571|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953572|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953573|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953574|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953575|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953576|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953577|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953578|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953579|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953580|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953581|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953582|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953583|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953584|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953585|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953586|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953587|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953588|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953589|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953590|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953591|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953592|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953593|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953594|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953822|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
953595|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953596|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953597|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953598|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953599|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953600|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953601|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953602|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953603|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953604|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953605|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953606|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953607|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953608|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953609|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953610|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953611|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953612|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953613|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953614|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953615|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953616|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953617|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953618|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953619|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953620|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953621|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953622|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953623|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953624|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953625|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953626|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953627|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953628|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953629|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953630|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953631|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953632|NCT00944073|O2|Outcome|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953633|NCT00944073|O1|Outcome|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953634|NCT00944073|E2|Reported Event|30 mcg H1N1 Vaccine|Participants received 30 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953635|NCT00944073|E1|Reported Event|15 mcg H1N1 Vaccine|Participants received 15 mcg of Inactivated H1N1 Vaccine by intramuscular injection on Day 0 and Day 21.
953636|NCT00944034|B13|Baseline|Total|Total of all reporting groups
953637|NCT00944034|B12|Baseline|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
953638|NCT00944034|B11|Baseline|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
953639|NCT00944034|B10|Baseline|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
953818|NCT00943917|P3|Participant Flow|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
953640|NCT00944034|B9|Baseline|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953641|NCT00944034|B8|Baseline|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953642|NCT00944034|B7|Baseline|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
953643|NCT00944034|B6|Baseline|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953644|NCT00944034|B5|Baseline|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953681|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
953645|NCT00944034|B4|Baseline|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953646|NCT00944034|B3|Baseline|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953647|NCT00944034|B2|Baseline|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953648|NCT00944034|B1|Baseline|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953649|NCT00944034|P12|Participant Flow|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
953650|NCT00944034|P11|Participant Flow|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
953651|NCT00944034|P10|Participant Flow|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
953652|NCT00944034|P9|Participant Flow|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953653|NCT00944034|P8|Participant Flow|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953654|NCT00944034|P7|Participant Flow|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
953655|NCT00944034|P6|Participant Flow|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953656|NCT00944034|P5|Participant Flow|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953657|NCT00944034|P4|Participant Flow|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953658|NCT00944034|P3|Participant Flow|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953659|NCT00944034|P2|Participant Flow|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953660|NCT00944034|P1|Participant Flow|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.age
953661|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
953662|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
953663|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
953664|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953665|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953666|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953667|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
953668|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
953669|NCT00944034|O1|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
953670|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953671|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953672|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
953673|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953674|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953819|NCT00943917|P2|Participant Flow|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
953675|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953676|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953677|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953678|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953679|NCT00944034|O3|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
953680|NCT00944034|O2|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
953682|NCT00944034|O8|Outcome|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
953683|NCT00944034|O7|Outcome|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
953684|NCT00944034|O6|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953685|NCT00944034|O5|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953686|NCT00944034|O4|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953687|NCT00944034|O3|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953688|NCT00944034|O2|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953689|NCT00944034|O1|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953690|NCT00944034|O4|Outcome|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
953691|NCT00944034|O3|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
953692|NCT00944034|O2|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953693|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953694|NCT00944034|O9|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953695|NCT00944034|O8|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953696|NCT00944034|O7|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
953697|NCT00944034|O6|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953698|NCT00944034|O5|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953699|NCT00944034|O4|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953700|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953701|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953702|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953703|NCT00944034|O3|Outcome|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953704|NCT00944034|O2|Outcome|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953705|NCT00944034|O1|Outcome|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
953706|NCT00944034|O3|Outcome|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953707|NCT00944034|O2|Outcome|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953708|NCT00944034|O1|Outcome|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953709|NCT00944034|O3|Outcome|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953710|NCT00944034|O2|Outcome|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953711|NCT00944034|O1|Outcome|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953712|NCT00944034|E12|Reported Event|B24 26|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 24 and 26 months of age.
953713|NCT00944034|E11|Reported Event|B18 20|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 18 and 20 months of age.
953714|NCT00944034|E10|Reported Event|B12 14|Previously received two catch-up doses of rMenB+OMV NZ vaccine at 12 and14 months of age.
953715|NCT00944034|E9|Reported Event|B+R234_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953716|NCT00944034|E8|Reported Event|B+R234_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
957189|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
953717|NCT00944034|E7|Reported Event|B+R234_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 3 and 4 months of age followed by a booster dose of rMenB+OMV NZ at 12 months of age.
953718|NCT00944034|E6|Reported Event|B246_24|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 24 months of age.
953719|NCT00944034|E5|Reported Event|B246_18|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3,5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ at 18 months of age.
953720|NCT00944034|E4|Reported Event|B246_12|Previously received 3 doses of rMenB+OMV NZ vaccine at 2, 4 and 6 months of age and routine vaccines at 3, 5 and 7 months of age, followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953721|NCT00944034|E3|Reported Event|B+R246_24|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 24 months of age.
953722|NCT00944034|E2|Reported Event|B+R246_18|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 18 months of age.
953723|NCT00944034|E1|Reported Event|B+R246_12|Previously received rMenB+OMV NZ vaccine + routine vaccines at 2, 4 and 6 months of age followed by a booster dose of rMenB+OMV NZ vaccine at 12 months of age.
953724|NCT00944021|B6|Baseline|Total|Total of all reporting groups
953725|NCT00944021|B5|Baseline|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953726|NCT00944021|B4|Baseline|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953727|NCT00944021|B3|Baseline|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953728|NCT00944021|B2|Baseline|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953729|NCT00944021|B1|Baseline|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953730|NCT00944021|P5|Participant Flow|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953731|NCT00944021|P4|Participant Flow|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953732|NCT00944021|P3|Participant Flow|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953733|NCT00944021|P2|Participant Flow|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953734|NCT00944021|P1|Participant Flow|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953735|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953736|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953737|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953738|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953739|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953740|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953741|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953742|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953743|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953744|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953745|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953746|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953747|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953748|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953749|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953750|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953751|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953752|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953753|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953754|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953755|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953756|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953757|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953758|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953759|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953760|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953761|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953762|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953763|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953764|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953820|NCT00943917|P1|Participant Flow|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
953765|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953766|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953767|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953768|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953769|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953770|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953771|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953772|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953773|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953774|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953834|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
953775|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953776|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953777|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953778|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953779|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953780|NCT00944021|O5|Outcome|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953781|NCT00944021|O4|Outcome|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953782|NCT00944021|O3|Outcome|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953783|NCT00944021|O2|Outcome|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953784|NCT00944021|O1|Outcome|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953785|NCT00944021|E5|Reported Event|Rifafour e-275mg|Rifafour e-275 mg : A once daily dose dependent on the patients weight 30 to 37 kg - 2 tablets, 38 to 54 kg - 3 tablets, 55 to 70 kg - 4 tablets or 71 kg and over - 5 tablets).
953786|NCT00944021|E4|Reported Event|PA-824 200mg/qd|PA-824 : 200 mg oral tablet
953787|NCT00944021|E3|Reported Event|PA-824 150mg/qd|PA-824 : 150 mg oral tablet
953788|NCT00944021|E2|Reported Event|PA-824 100mg/qd|PA-824 : 100mg oral tablet
953789|NCT00944021|E1|Reported Event|PA-824 50 mg/qd|PA-824 : 50mg oral tablet
953790|NCT00943917|B16|Baseline|Total|Total of all reporting groups
953791|NCT00943917|B15|Baseline|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
953792|NCT00943917|B14|Baseline|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
953793|NCT00943917|B13|Baseline|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
953794|NCT00943917|B12|Baseline|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
953795|NCT00943917|B11|Baseline|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
953796|NCT00943917|B10|Baseline|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
953797|NCT00943917|B9|Baseline|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
953798|NCT00943917|B8|Baseline|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
953799|NCT00943917|B7|Baseline|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
953800|NCT00943917|B6|Baseline|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
953801|NCT00943917|B5|Baseline|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
953802|NCT00943917|B4|Baseline|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
953803|NCT00943917|B3|Baseline|Exenatide Injection- STAGE I|exenatide injection twice a day: 5 mcg/dose first 4 weeks then 10 mcg/dose for next 8 weeks
953804|NCT00943917|B2|Baseline|ITCA 650 40 mcg/Day- STAGE I|ITCA 650 40 mcg/day continuous exenatide
953805|NCT00943917|B1|Baseline|ITCA 650 20 mcg/Day- STAGE I|ITCA 650 20 mcg/day continuous exenatide
953806|NCT00943917|P15|Participant Flow|Ex Inj/ITCA 650 60 Continuation|Exenatide injection twice daily first 12 weeks then ITCA 650 60 mcg/day through Week 48
953807|NCT00943917|P14|Participant Flow|Ex Inj/ITCA 650 40 Continuation|Exenatide injection twice/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
953808|NCT00943917|P13|Participant Flow|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 48
953809|NCT00943917|P12|Participant Flow|ITCA 650 40/40 Contination|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
953810|NCT00943917|P11|Participant Flow|ITCA 650 20/40 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 48
953811|NCT00943917|P10|Participant Flow|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 through Week 48
953812|NCT00943917|P9|Participant Flow|Ex Inj/ITCA 650 60 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 60 mcg/day through Week 24
953813|NCT00943917|P8|Participant Flow|Ex Inj/ITCA 650 40 mcg/Day- STAGE II|Exenatide injection twice/day for 12 weeks then ITCA 650 40 mcg/day through Week 24
953814|NCT00943917|P7|Participant Flow|ITCA 650 40/80 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day through Week 24
953815|NCT00943917|P6|Participant Flow|ITCA 650 40/40 - STAGE II|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day through Week 24
953816|NCT00943917|P5|Participant Flow|ITCA 650 20/60- STAGE II|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day through Week 24
953817|NCT00943917|P4|Participant Flow|ITCA 650 20/20- STAGE II|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 24
953821|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
953823|NCT00943917|O4|Outcome|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
953824|NCT00943917|O3|Outcome|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
953825|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
953826|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
953827|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
953828|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
953829|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
953830|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
953831|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
953832|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II Continuation
953833|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
953837|NCT00943917|O2|Outcome|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
953838|NCT00943917|O1|Outcome|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
953839|NCT00943917|O6|Outcome|Ex Inj/ITCA 650 60|Stage II & Stage II Continuation
953840|NCT00943917|O5|Outcome|Ex Inj/ITCA 650 40|Stage II & Stage II Continuation
953841|NCT00943917|O4|Outcome|ITCA 650 40/80|Stage II & Stage II Continuation
953842|NCT00943917|O3|Outcome|ITCA 650 40/40|Stage II & Stage II Continuation
953843|NCT00943917|O2|Outcome|ITCA 650 20/60|Stage II & Stage II Continuation
953844|NCT00943917|O1|Outcome|ITCA 650 20/20|Stage II & Stage II Continuation
953845|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
953846|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
953847|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
953848|NCT00943917|O3|Outcome|Exenatide Injection - STAGE I|Exenatide injection twice daily: 5 mcg/dose first 4 weeks then 10 mcg/dose through Week 12
953849|NCT00943917|O2|Outcome|ITCA 650 40 mcg/Day - STAGE I|ITCA 650 40 mcg/day through Week 12
953850|NCT00943917|O1|Outcome|ITCA 650 20 mcg/Day - STAGE I|ITCA 650 20 mcg/day through Week 12
953851|NCT00943917|E15|Reported Event|Ex Inj/ITCA 650 60 Continutation|Exenatide injection first 12 weeks, then ITCA 650 60 mcg/day through Week 48
953852|NCT00943917|E14|Reported Event|Ex Inj/ITCA 40 Continuation|Exenatide twice/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
953853|NCT00943917|E13|Reported Event|ITCA 650 40/80 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 80 mcg/day through Week 48
953854|NCT00943917|E12|Reported Event|ITCA 650 40/40 Continuation|ITCA 650 40 mcg/day first 12 weeks, then ITCA 650 40 mcg/day through Week 48
953855|NCT00943917|E11|Reported Event|ITCA 650 20/60 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 60 mcg/day through Week 48
953856|NCT00943917|E10|Reported Event|ITCA 650 20/20 Continuation|ITCA 650 20 mcg/day first 12 weeks, then ITCA 650 20 mcg/day through Week 48
953857|NCT00943917|E9|Reported Event|Ex Inj/ITCA 650 60|Exenatide injection first 12 weeks then ITCA 650 60 mcg/day
953858|NCT00943917|E8|Reported Event|Ex Inj/ITCA 650 40|Exenatide injection first 12 weeks then ITCA 650 40 mcg/day
953859|NCT00943917|E7|Reported Event|ITCA 650 40/80|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 80 mcg/day
953860|NCT00943917|E6|Reported Event|ITCA 650 40/40|ITCA 650 40 mcg/day first 12 weeks then ITCA 650 40 mcg/day
953861|NCT00943917|E5|Reported Event|ITCA 650 20/60|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 60 mcg/day
953862|NCT00943917|E4|Reported Event|ITCA 650 20/20|ITCA 650 20 mcg/day first 12 weeks then ITCA 650 20 mcg/day
953863|NCT00943917|E3|Reported Event|Exenatide Injection|exenatide injection twice daily dosing: 5 mcg/dose first 4 weeks then 10 mcg/day next 8 weeks
953864|NCT00943917|E2|Reported Event|ITCA 650 40 mcg/Day|ITCA 650 40 mcg/day continuous exenatide
953865|NCT00943917|E1|Reported Event|ITCA 650 20 mcg/Day|ITCA 650 20 mcg/day continuous exenatide
953866|NCT00943878|B5|Baseline|Total|Total of all reporting groups
953867|NCT00943878|B4|Baseline|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953868|NCT00943878|B3|Baseline|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953869|NCT00943878|B2|Baseline|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953870|NCT00943878|B1|Baseline|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953871|NCT00943878|P4|Participant Flow|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953872|NCT00943878|P3|Participant Flow|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953873|NCT00943878|P2|Participant Flow|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953874|NCT00943878|P1|Participant Flow|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954846|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
953875|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953876|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953877|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953878|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953879|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953880|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
957190|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
953881|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953882|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953883|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953884|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953885|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953886|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953887|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953888|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953889|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953890|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953891|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953892|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953893|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953894|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953895|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953896|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953897|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953898|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953899|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953900|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953901|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953902|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953903|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953904|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
954847|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
953905|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953906|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953907|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953908|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953909|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953910|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953911|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953912|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953913|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953914|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953915|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953916|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953917|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953918|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953919|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953920|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953921|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953922|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953923|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953924|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953925|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953926|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953927|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953928|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953929|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953930|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953931|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953932|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953933|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953934|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954848|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
953935|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953936|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953937|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953938|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953939|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953940|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953941|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953942|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953943|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953944|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953945|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953946|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953947|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953948|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953949|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953950|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953951|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953952|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953953|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953954|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953955|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953956|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953957|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953958|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953959|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953960|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953961|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953962|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953963|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953964|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
954849|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
953965|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953966|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953967|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953968|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953969|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953970|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953971|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953972|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953973|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953974|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953975|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953976|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953977|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953978|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953979|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953980|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953981|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953982|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953983|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953984|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953985|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953986|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953987|NCT00943878|O4|Outcome|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953988|NCT00943878|O3|Outcome|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953989|NCT00943878|O2|Outcome|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953990|NCT00943878|O1|Outcome|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953991|NCT00943878|E4|Reported Event|Group 4: TIV+Placebo; H1N1+Placebo; H1N1|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953992|NCT00943878|E3|Reported Event|Group 3: H1N1+Placebo; H1N1+TIV; Placebo|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21, and saline placebo on Day 42
953993|NCT00943878|E2|Reported Event|Group 2: H1N1+TIV; H1N1+Placebo; Placebo|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and saline placebo on Day 42
953994|NCT00943878|E1|Reported Event|Group 1: H1N1+Placebo; H1N1+Placebo; TIV|Participants received 15 mcg H1N1 Vaccine + saline placebo on Day 0; 15 mcg H1N1 Vaccine + saline placebo on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
953995|NCT00943852|B1|Baseline|All Participants in Study|
953996|NCT00943852|P10|Participant Flow|Losartan + ISMN / Losartan / Placebo / Losartan + ISMN / ISMN|Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / Placebo / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
953997|NCT00943852|P9|Participant Flow|Losartan + ISMN / Placebo / Losartan + ISMN / ISMN / Losartan|Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
953998|NCT00943852|P8|Participant Flow|ISMN / Losartan + ISMN / Losartan + ISMN / Losartan / Placebo|ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg / Placebo – single dose with ≥ 4 days washout between doses
953999|NCT00943852|P7|Participant Flow|Losartan / Losartan + ISMN / ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / Losartan 100 mg + ISMN 15 mg / ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
954000|NCT00943852|P6|Participant Flow|Placebo / ISMN / Losartan / Losartan + ISMN / Losartan + ISMN|Placebo / ISMN 60 mg / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
955007|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
954001|NCT00943852|P5|Participant Flow|Losartan + ISMN / Placebo / ISMN / Losartan + ISMN / Losartan|Losartan 100 mg + ISMN 60 mg / Placebo / ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Losartan 100 mg – single dose with ≥ 4 days washout between doses
954002|NCT00943852|P4|Participant Flow|Losartan + ISMN / Losartan + ISMN / Losartan / ISMN / Placebo|Losartan 100 mg + ISMN 15 mg / Losartan 100 mg + ISMN 60 mg / Losartan 100 mg / ISMN 60 mg / Placebo – single dose with ≥ 4 days washout between doses
954003|NCT00943852|P3|Participant Flow|ISMN / Losartan + ISMN / Placebo / Losartan / Losartan + ISMN|ISMN 60 mg / Losartan 100 mg + ISMN 15 mg / Placebo / Losartan 100 mg / Losartan 100 mg + ISMN 60 mg – single dose with ≥ 4 days washout between doses
954004|NCT00943852|P2|Participant Flow|Losartan / ISMN / Losartan + ISMN / Placebo / Losartan + ISMN|Losartan 100 mg / ISMN 60 mg / Losartan 100 mg + ISMN 60 mg / Placebo / Losartan 100 mg + ISMN 15 mg – single dose with ≥ 4 days washout between doses
954005|NCT00943852|P1|Participant Flow|Placebo / Losartan / Losartan + ISMN / Losartan + ISMN / ISMN|Placebo / Losartan 100 mg / Losartan 100 mg + Isosorbide Mononitrate (ISMN) 15 mg / Losartan 100 mg + ISMN 60 mg / ISMN 60 mg – single dose with ≥ 4 days washout between doses
954006|NCT00943852|O2|Outcome|Placebo|
954007|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
954008|NCT00943852|O2|Outcome|Losartan 100 mg|
954009|NCT00943852|O1|Outcome|Losartan 100 mg + ISMN 60 mg|
954010|NCT00943852|E5|Reported Event|ISMN 60 mg|
954011|NCT00943852|E4|Reported Event|Losartan 100 mg + ISMN 60 mg|
954012|NCT00943852|E3|Reported Event|Losartan 100 mg + ISMN 15 mg|
954013|NCT00943852|E2|Reported Event|Losartan 100 mg|
954014|NCT00943852|E1|Reported Event|Placebo|
954015|NCT00943826|B3|Baseline|Total|Total of all reporting groups
954016|NCT00943826|B2|Baseline|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
954017|NCT00943826|B1|Baseline|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
954018|NCT00943826|P2|Participant Flow|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression//unacceptable toxicity.
954019|NCT00943826|P1|Participant Flow|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy (RT) in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
954020|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
954021|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
954022|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
954023|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
955008|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
954024|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
954025|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
954026|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
954027|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
954028|NCT00943826|O2|Outcome|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
954029|NCT00943826|O1|Outcome|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
954030|NCT00943826|E2|Reported Event|Placebo + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and placebo IV every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of placebo IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received placebo IV every 3 weeks until disease progression/unacceptable toxicity.
954031|NCT00943826|E1|Reported Event|Bevacizumab + RT+Temozolomide|In the Concurrent Phase participants received radiotherapy in daily fractions of 2 Gy given 5 days per week for 6 week and temozolomide 75 mg/m^2 daily for a maximum of 49 days and bevacizumab 10 mg/kg intravenous (IV) every 2 weeks for 6 weeks. There was a 4 week treatment break. Participants then entered the Maintenance Phase where they received six 28-day cycle of bevacizumab 10 mg/kg IV every 2 weeks and temozolomide 150 to 200 mg/m^2 daily in the first 5 days of each cycle. The participants then entered the Monotherapy Phase where they received bevacizumab 15 mg/kg IV every 3 weeks until disease progression/unacceptable toxicity.
954032|NCT00943787|B1|Baseline|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
954033|NCT00943787|P1|Participant Flow|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
954034|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
954035|NCT00943787|O1|Outcome|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
954036|NCT00943787|E1|Reported Event|Adults With T1DM From Subjects|Subjects with type 1 diabetes performed self-monitoring of blood glucose (SMBG) for a month, followed by an inpatient hyperinsulinemic euglycemic and hypoglycemic clamp. SMBG field data were used to calculate measures of glucose variability and risk of hypoglycemia, while the clamp procedure was used to evaluate insulin sensitivity and epinephrine response during induced hypoglycemia.
954038|NCT00943761|B2|Baseline|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
954039|NCT00943761|B1|Baseline|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
954040|NCT00943761|P2|Participant Flow|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
954041|NCT00943761|P1|Participant Flow|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination pegylated interferon (peg-IFN) 180 mcg weekly and ribavirin (RBV) 1000 or 1200 mg administered as a divided dose twice daily.
954042|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
954043|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
954044|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
954045|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
954046|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
954047|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
954048|NCT00943761|O2|Outcome|Vaniprevir 600 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and ribavirin 1000 or 1200 mg administered as a divided dose twice daily.
954049|NCT00943761|O1|Outcome|Vaniprevir 300 mg b.i.d. + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
954050|NCT00943761|E2|Reported Event|Vaniprevir 600 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 600 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
954051|NCT00943761|E1|Reported Event|Vaniprevir 300 mg Bid + Peg-IFN + RBV|Participants received vaniprevir 300 mg twice daily in combination peg-IFN 180 mcg weekly and RBV 1000 or 1200 mg administered as a divided dose twice daily.
954052|NCT00943735|B1|Baseline|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954053|NCT00943735|P1|Participant Flow|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954054|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954055|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954056|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954057|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954058|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954059|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954060|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954061|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954062|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954063|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954064|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954065|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954066|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954067|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954068|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954069|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954070|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954071|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954072|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954073|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954850|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954074|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954075|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954076|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954077|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954078|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954079|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954080|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954081|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954082|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954083|NCT00943735|O1|Outcome|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954084|NCT00943735|E1|Reported Event|Fesoterodine 4 mg or 8 mg|Fesoterodine 4 mg or 8 mg tablet PO, QD
954085|NCT00943722|B6|Baseline|Total|Total of all reporting groups
957191|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
954086|NCT00943722|B5|Baseline|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954087|NCT00943722|B4|Baseline|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954088|NCT00943722|B3|Baseline|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
954089|NCT00943722|B2|Baseline|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
954090|NCT00943722|B1|Baseline|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954091|NCT00943722|P5|Participant Flow|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954092|NCT00943722|P4|Participant Flow|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954093|NCT00943722|P3|Participant Flow|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
954094|NCT00943722|P2|Participant Flow|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
954095|NCT00943722|P1|Participant Flow|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954096|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
954097|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
954098|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954099|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954100|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954101|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954102|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954103|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954104|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954105|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2, or 3)|Multivalent HPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3.
954106|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954107|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954108|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
954109|NCT00943722|O3|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954110|NCT00943722|O2|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954141|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954111|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
954112|NCT00943722|O3|Outcome|9- to 15-Year-Old Females (Lot 3)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 3.
954113|NCT00943722|O2|Outcome|9- to 15-Year-Old Females (Lot 2)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 2.
954114|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954115|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954869|NCT00942448|E4|Reported Event|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
954116|NCT00943722|O1|Outcome|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954117|NCT00943722|O2|Outcome|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954118|NCT00943722|O1|Outcome|9- to 15-Year-Old Females (Lot 1)|9-valent human papillomavirus (9vHPV) L1 virus-like particle (VLP) vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954119|NCT00943722|E3|Reported Event|16- to 26-Year-Old Females (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954120|NCT00943722|E2|Reported Event|9- to 15-Year-Old Males (Lot 1)|9vHPV L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lot 1.
954121|NCT00943722|E1|Reported Event|9- to 15-Year-Old Females (Lots 1, 2 or 3)|9-valent human papillomavirus (9vHPV) L1 VLP vaccine, 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6. Vaccine dose administered is obtained from manufacturing Lots 1, 2, or 3
954122|NCT00943683|B3|Baseline|Total|Total of all reporting groups
954123|NCT00943683|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
954124|NCT00943683|B1|Baseline|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
954125|NCT00943683|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
954126|NCT00943683|P1|Participant Flow|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
954127|NCT00943683|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
954128|NCT00943683|O1|Outcome|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
954129|NCT00943683|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks
954130|NCT00943683|E1|Reported Event|Placebo|Montelukast matching placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks
954131|NCT00943670|B1|Baseline|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
954132|NCT00943670|P1|Participant Flow|T-DM1 / T-DM1 + Pertuzumab|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~From Cycle 4, participants with early Progressive disease (demonstrated prior to the end of Cycle 6) could receive combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, starting at the cycle after tumor progression was determined, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
954133|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954134|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954135|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954136|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954137|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954138|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954139|NCT00943670|O1|Outcome|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954140|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
954174|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954142|NCT00943670|O2|Outcome|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
954143|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954144|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
954145|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
954146|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
954147|NCT00943670|O1|Outcome|T-DM1|"Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.~Participants who met criteria for ongoing clinical benefit were allowed to continue study treatment in the absence of disease progression or unacceptable toxicity for up to 1 year."
954148|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954149|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954150|NCT00943670|O3|Outcome|Baseline-adjusted QTc Interval > 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954151|NCT00943670|O2|Outcome|Baseline-adjusted QTc Interval > 30 to ≤ 60 ms|Participants with an average Baseline-adjusted QTc interval greater than 30 and less than or equal to 60 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954152|NCT00943670|O1|Outcome|Baseline-adjusted QTc Interval ≤ 30 ms|Participants with an average Baseline-adjusted QTc interval less than or equal to 30 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954153|NCT00943670|O4|Outcome|Average QTc Interval > 500 ms|Participants with an average QTc interval greater than 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954154|NCT00943670|O3|Outcome|Average QTc Interval > 480 to ≤ 500 ms|Participants with an average QTc interval greater than 480 and less than or equal to 500 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954155|NCT00943670|O2|Outcome|Average QTc Interval > 450 to ≤ 480 ms|Participants with an average QTc interval greater than 450 and less than or equal to 480 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954156|NCT00943670|O1|Outcome|Average QTc Interval ≤ 450 ms|Participants with an average QTc interval less than or equal to 450 ms who received trastuzumab emtansine (T-DM1) by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954157|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954158|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954159|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954160|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954161|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954162|NCT00943670|O1|Outcome|T-DM1|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954163|NCT00943670|E2|Reported Event|T-DM1 + Pertuzumab|Participants who received combined pertuzumab and trastuzumab emtansine. Pertuzumab was administered after trastuzumab emtansine by IV infusion at a loading dose of 840 mg on Day 1, followed by 420 mg IV infusion every 3 weeks in subsequent cycles.
954164|NCT00943670|E1|Reported Event|Single-Agent T-DM1 Treatment|Trastuzumab emtansine (T-DM1) was administered to participants by intravenous (IV) infusion on Day 1 of every 3 week cycle at a dose of 3.6 mg/kg.
954165|NCT00943631|B3|Baseline|Total|Total of all reporting groups
954166|NCT00943631|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954167|NCT00943631|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954168|NCT00943631|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954169|NCT00943631|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954170|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954171|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954172|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954173|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954175|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954176|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954177|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954178|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954179|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954180|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954181|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
955059|NCT00941733|B2|Baseline|Standard PTA|Standard PTA balloon: Balloon Angioplasty
954182|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954183|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954184|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954185|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954186|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954187|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954188|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954189|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954190|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954191|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954192|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954193|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954194|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954195|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954196|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954197|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954198|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954199|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954200|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954201|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954202|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954203|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954204|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954205|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954206|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954207|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954208|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954209|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954210|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954211|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954212|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954213|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954214|NCT00943631|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954215|NCT00943631|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954216|NCT00943631|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954217|NCT00943631|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954218|NCT00943605|B3|Baseline|Total|Total of all reporting groups
954219|NCT00943605|B2|Baseline|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
954220|NCT00943605|B1|Baseline|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
954221|NCT00943605|P2|Participant Flow|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
954851|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954222|NCT00943605|P1|Participant Flow|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
954223|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
954224|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
954225|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
954226|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
954227|NCT00943605|O2|Outcome|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
957192|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
954228|NCT00943605|O1|Outcome|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
954229|NCT00943605|E2|Reported Event|PEAK PlasmaBlade|The entirety of the mastectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
954230|NCT00943605|E1|Reported Event|Standard of Care (SOC)|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
954231|NCT00943592|B1|Baseline|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954232|NCT00943592|P1|Participant Flow|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954233|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954234|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954235|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954236|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954237|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954238|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954239|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954240|NCT00943592|O1|Outcome|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954241|NCT00943592|E1|Reported Event|Clofarabine, Melphalan, and Alemtuzumab|Clofarabine was initially administered IV infusion over 1 hour on days -7 through -3 (4 dose levels from 10 to 40 mg/m2); subsequently, the protocol was amended to infuse clofarabine over 3 hours. Melphalan (doses ranging from 100 to 140 mg/m2) was infused over 30 minutes on day -2. Alemtuzumab was administered at 20 mg IV infusion on day -7 through day -3 over 1 hour.
954242|NCT00943579|B3|Baseline|Total|Total of all reporting groups
954243|NCT00943579|B2|Baseline|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
954244|NCT00943579|B1|Baseline|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
954245|NCT00943579|P2|Participant Flow|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
954288|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954246|NCT00943579|P1|Participant Flow|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
954247|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
954248|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
954294|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
957193|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
954249|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
954250|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
954251|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|
954252|NCT00943579|O1|Outcome|Kuvan Following Placebo|
954253|NCT00943579|O2|Outcome|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
954254|NCT00943579|O1|Outcome|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
954255|NCT00943579|E2|Reported Event|Kuvan Following Active Treatment|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on active medication.
954256|NCT00943579|E1|Reported Event|Kuvan Following Placebo|Kuvan® (sapropterin) will be administered to all subjects at 20 mg/kg/day for 16 weeks. Participants in this arm received Kuvan following the randomized control trial in which they were on placebo.
954257|NCT00943488|B3|Baseline|Total|Total of all reporting groups
954258|NCT00943488|B2|Baseline|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954259|NCT00943488|B1|Baseline|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954260|NCT00943488|P2|Participant Flow|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954261|NCT00943488|P1|Participant Flow|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954262|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954263|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954264|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954265|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954266|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954267|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954268|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954269|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954270|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954271|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954272|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954273|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954274|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954275|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954276|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954277|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954278|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954279|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954280|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954281|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954282|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954283|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954284|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954285|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954286|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954287|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954289|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954290|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954291|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954292|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954293|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954295|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954296|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954297|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954298|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954299|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954300|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954301|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954302|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954303|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954304|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954305|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954306|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954307|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954308|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954309|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954310|NCT00943488|O2|Outcome|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954311|NCT00943488|O1|Outcome|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954312|NCT00943488|E2|Reported Event|H1N1 Vaccine 30 Mcg|Participants received 30 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954313|NCT00943488|E1|Reported Event|H1N1 Vaccine 15 Mcg|Participants received 15 mcg of H1N1 vaccine by intramuscular injection on Days 0 and 21.
954314|NCT00943436|B3|Baseline|Total|Total of all reporting groups
954315|NCT00943436|B2|Baseline|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954316|NCT00943436|B1|Baseline|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954317|NCT00943436|P2|Participant Flow|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954318|NCT00943436|P1|Participant Flow|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954319|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954320|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954321|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954322|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954323|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954324|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954325|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954326|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954327|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954328|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954329|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954330|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954331|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954332|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954333|NCT00943436|O2|Outcome|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954334|NCT00943436|O1|Outcome|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954335|NCT00943436|E2|Reported Event|Inactive Lifestyle Males|males that exercise less than or equal to 1 day/week at 1 hour/day
954336|NCT00943436|E1|Reported Event|Active Lifestyle Males|Males that exercise greater than or equal to 5 days/wk at 30 min/day
954337|NCT00943397|B3|Baseline|Total|Total of all reporting groups
954338|NCT00943397|B2|Baseline|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
954615|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954339|NCT00943397|B1|Baseline|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
954340|NCT00943397|P2|Participant Flow|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
954341|NCT00943397|P1|Participant Flow|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
954342|NCT00943397|O2|Outcome|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
954619|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954343|NCT00943397|O1|Outcome|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
954344|NCT00943397|E2|Reported Event|Montelukast|Montelukast 4-mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks.
954345|NCT00943397|E1|Reported Event|Usual Care|Usual care: defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator’s usual clinical practice for 52 weeks
954346|NCT00943384|B1|Baseline|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954347|NCT00943384|P1|Participant Flow|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954348|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954349|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954350|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954351|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954352|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954353|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954354|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954355|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954356|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954357|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954358|NCT00943384|O1|Outcome|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954359|NCT00943384|E1|Reported Event|chronOS Strip|Patients with DDD (with or without stenosis) were treated at one or two contiguous levels between L1 and S1 (inclusive) with interbody fusion and a posterolateral pedicle screw system. The study device (chronOS Strip) was applied to the posterolateral gutters combined with bone marrow aspirate and local bone.
954360|NCT00943202|B5|Baseline|Total|Total of all reporting groups
954361|NCT00943202|B4|Baseline|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954362|NCT00943202|B3|Baseline|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954363|NCT00943202|B2|Baseline|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954364|NCT00943202|B1|Baseline|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954852|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954365|NCT00943202|P4|Participant Flow|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954366|NCT00943202|P3|Participant Flow|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954367|NCT00943202|P2|Participant Flow|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954662|NCT00943098|B2|Baseline|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954368|NCT00943202|P1|Participant Flow|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954369|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954370|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954371|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954372|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954373|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954374|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954375|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954376|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954377|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954378|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954379|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954380|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954381|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954382|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954383|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954384|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954385|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954386|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954387|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954388|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954389|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954390|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954391|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954392|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954393|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954394|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954395|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954396|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954397|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954398|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954399|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954853|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954400|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954401|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954402|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954403|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954404|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954405|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954406|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954407|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954408|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954409|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954410|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954411|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954412|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954413|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954414|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954415|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954416|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954417|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954418|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954419|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954420|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954421|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954422|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954423|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954424|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954425|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954426|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954427|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954428|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954429|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954430|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954431|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954432|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954433|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954434|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954854|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954435|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954436|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954437|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954438|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954439|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954440|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954441|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954442|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954443|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954444|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954445|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954446|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954447|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954448|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954449|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954450|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954451|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954452|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954453|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954454|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954455|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954456|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954457|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954458|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954459|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954460|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954461|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954462|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954463|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954464|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954465|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954466|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954467|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954468|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954469|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954855|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954470|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954471|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954472|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
957194|NCT00935064|E2|Reported Event|Placebo|Once daily, for 6 weeks
954473|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954474|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954475|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954476|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954477|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954478|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954479|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954480|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954481|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954482|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954483|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954484|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954485|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954486|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954487|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954488|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954489|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954490|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954491|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954492|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954493|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954494|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954495|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954496|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954497|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954498|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954499|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954500|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954501|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954502|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954503|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954504|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954856|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954505|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954506|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954507|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954508|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954509|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954510|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954511|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954512|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954513|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954514|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954515|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954516|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954517|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954518|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954519|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954520|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954521|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954522|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954523|NCT00943202|O2|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954524|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954525|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954526|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954527|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954528|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954529|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954530|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954531|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954532|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954533|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954534|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954535|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954536|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954537|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954538|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954539|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954857|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954540|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954541|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954542|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954543|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954544|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954545|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954546|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954547|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954548|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954549|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954550|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954551|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954552|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954553|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954554|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954555|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954556|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954557|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954558|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954559|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954560|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954561|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954562|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954563|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954564|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954565|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954566|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954567|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954568|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954569|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954570|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954571|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954572|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954573|NCT00943202|O4|Outcome|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954574|NCT00943202|O3|Outcome|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954858|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954575|NCT00943202|O2|Outcome|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954576|NCT00943202|O1|Outcome|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954577|NCT00943202|E4|Reported Event|Group 4: Day 0-TIV; Day 21-H1N1; Day 42-H1N1|Participants received Trivalent Influenza Vaccine (TIV) on Day 0; 15 mcg H1N1 Vaccine on Day 21, and 15 mcg H1N1 Vaccine on Day 42.
954578|NCT00943202|E3|Reported Event|Group 3: Day 0-H1N1; Day 21-H1N1+TIV|Participants received 15 mcg H1N1 Vaccine on Day 0 and 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 21
954579|NCT00943202|E2|Reported Event|Group 2: Day 0-H1N1+TIV; Day 21-H1N1|Participants received 15 mcg H1N1 Vaccine + Trivalent Influenza Vaccine (TIV) on Day 0 and 15 mcg H1N1 Vaccine on Day 21
954580|NCT00943202|E1|Reported Event|Group 1: Day 0-H1N1; Day 21-H1N1; Day 42-TIV|Participants received 15 mcg H1N1 Vaccine on Day 0; 15 mcg H1N1 Vaccine on Day 21, and Trivalent Influenza Vaccine (TIV) on Day 42
954581|NCT00943150|B3|Baseline|Total|Total of all reporting groups
954582|NCT00943150|B2|Baseline|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954583|NCT00943150|B1|Baseline|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954584|NCT00943150|P2|Participant Flow|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954585|NCT00943150|P1|Participant Flow|PEAK PlasmaBlade|The PEAK PlasmaBlade for the abdominoplasty procedure.
954586|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954587|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954588|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954589|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954590|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954591|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954592|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954593|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954594|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954595|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954596|NCT00943150|O2|Outcome|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954597|NCT00943150|O1|Outcome|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954598|NCT00943150|O3|Outcome|Scalpel|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
954599|NCT00943150|O2|Outcome|Electrosurgery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
954600|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
954601|NCT00943150|O2|Outcome|Electrocautery|The standard of care for abdominoplasty consists of scalpel (for the skin incision) and traditional electrosurgery (for the subcutaneous dissection). Traditional electrosurgical instruments are used for the cutting and coagulation of soft tissues.
954602|NCT00943150|O1|Outcome|PEAK PlasmaBlade|A surgical instrument that uses pulsed radiofrequency (RF) energy for the cutting and coagulation of soft tissue (skin and subcutaneous tissues) with the precision of a scalpel and hemostatic capability of traditional electrosurgery.
954603|NCT00943150|E2|Reported Event|Standard of Care (SOC)|The scalpel and electrocautery will be used for the abdominoplasty procedure.
954604|NCT00943150|E1|Reported Event|PEAK PlasmaBlade|The PEAK PlasmaBlade will be used for the abdominoplasty procedure.
954605|NCT00943124|B1|Baseline|Overall Study Population|All randomized patients
954606|NCT00943124|P2|Participant Flow|Simvastatin + MK0524A Then MK0524B|"Period 1: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets.~Period 2: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet)."
954607|NCT00943124|P1|Participant Flow|MK0524B Then Simvastatin + MK0524A|"Period 1: 1 tablet of MK0524B (ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet).~Period 2: 1 tablet of simvastatin and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets."
954608|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954609|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954610|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954611|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954612|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954613|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954614|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954859|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954616|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954617|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954618|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
955060|NCT00941733|B1|Baseline|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
954620|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954621|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954622|NCT00943124|O2|Outcome|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954623|NCT00943124|O1|Outcome|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954624|NCT00943124|E2|Reported Event|Simvastatin + MK0524A|Simvastatin + MK0524A : 1 tablet of simvastatin 20 mg (ZOCOR) and 1 tablet of MK0524A (ER Niacin 1000 mg/laropiprant 20 mg) as separate tablets
954625|NCT00943124|E1|Reported Event|MK0524B|MK0524B: 1 tablet of ER Niacin 900 mg/laropiprant 20 mg/simvastatin 20 mg fixed dose combination tablet.
954626|NCT00943111|B3|Baseline|Total|Total of all reporting groups
954627|NCT00943111|B2|Baseline|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954628|NCT00943111|B1|Baseline|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954629|NCT00943111|P3|Participant Flow|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was <5 ng/mL next higher dose was administered whereas if the Genz-99067 trough plasma concentration was >=5 ng/mL the same dose was continued. PK assessment at Week 54 and Week 58 were used for dose adjustment after Week 56 and Week 60, respectively."
954630|NCT00943111|P2|Participant Flow|Imiglucerase: PAP|Imiglucerase (Cerezyme®) intravenous infusion every other week (q2w) up to Week 52 in doses equivalent to participant’s past enzyme replacement therapy (ERT) dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954631|NCT00943111|P1|Participant Flow|Eliglustat: PAP|Eliglustat tartrate (Genz-112638) capsule 50 milligram (mg) twice daily (BID) orally from Day 1 to Week 4 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 8, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 52. The dose adjustments after Week 4 and Week 8 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. If Genz-99067 trough plasma concentration was less than [<] 5 nanogram per milliliter [ng/mL] the next higher dose was administered whereas if the Genz-99067 trough plasma concentration was greater than or equal to [>=] 5 ng/mL the same dose was continued. The pharmacokinetic (PK) assessment at Week 2 and Week 6 were used for dose adjustment after Week 4 and Week 8, respectively.
954632|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
954633|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
954634|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
954635|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
954860|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954861|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954636|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
954637|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
954638|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954639|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954640|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954641|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954642|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954643|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954644|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954645|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954646|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954647|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954648|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954649|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954650|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954651|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954652|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954653|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954654|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954655|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954656|NCT00943111|O1|Outcome|Eliglustat: LTTP|"Participants from both the arms of PAP who completed PAP were included in this arm of LTTP.~Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.~Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz-99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations."
954657|NCT00943111|O2|Outcome|Imiglucerase: PAP|Imiglucerase intravenous infusion q2w up to Week 52 in doses equivalent to participant’s past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change.
954658|NCT00943111|O1|Outcome|Eliglustat: PAP|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52.
954659|NCT00943111|E2|Reported Event|Imiglucerase|PAP: Imiglucerase (Cerezyme®) intravenous infusion q2w up to Week 52 in doses equivalent to participant's past ERT dose prior to any unanticipated treatment interruption, dose reduction, or regimen change. LTTP: Participants originally randomized to imiglucerase received eliglustat tartrate capsule 50 mg BID orally from Week 52+1 Day to Week 56 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 60, and then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to 5 years. The dose adjustments after Week 56 and Week 60 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations.
954862|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954660|NCT00943111|E1|Reported Event|Eliglustat|PAP: Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50, 100 or 150 mg capsule BID orally up to Week 52. Dose adjustments after Week 4 and Week 8 were based on Genz­99067 (active moiety of eliglustat tartrate in plasma) trough plasma concentrations. LTTP: Participants originally randomized to eliglustat in PAP continued to receive eliglustat dose, based on their Genz 99067 plasma trough concentration at Week 6.
954661|NCT00943098|B3|Baseline|Total|Total of all reporting groups
955061|NCT00941733|P2|Participant Flow|Standard PTA|Standard PTA balloon: Balloon Angioplasty
954663|NCT00943098|B1|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954664|NCT00943098|P2|Participant Flow|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954665|NCT00943098|P1|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954666|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954667|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954668|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954669|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954670|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954671|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954672|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954673|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954674|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954675|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954676|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954677|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954678|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954679|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954680|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954681|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954682|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954683|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954684|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954685|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954686|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954687|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954688|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954689|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954690|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954691|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954692|NCT00943098|O2|Outcome|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954693|NCT00943098|O1|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954694|NCT00943098|E2|Reported Event|Voltarol 75mg/3ml i.m.|Voltarol 75mg/3ml i.m. : 1 single injection at day of dental surgical extraction
954695|NCT00943098|E1|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD s.c. 75mg/ml : 1 single injection at day of dental surgical extraction
954696|NCT00943072|B3|Baseline|Total|Total of all reporting groups
954697|NCT00943072|B2|Baseline|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
954698|NCT00943072|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
954699|NCT00943072|P2|Participant Flow|Sham Treatment|"Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
954724|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954863|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954864|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954725|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954726|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954700|NCT00943072|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.~Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg IAI PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
954701|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
954702|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
954703|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
954704|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
954705|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
954706|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
954707|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
954708|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
954709|NCT00943072|O2|Outcome|Sham Treatment|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 24.
954710|NCT00943072|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye)|Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 24.
954711|NCT00943072|E4|Reported Event|Sham Treatment to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were eligible for active treatment and were evaluated monthly to receive either 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given."
954712|NCT00943072|E3|Reported Event|IAI to IAI (Week 24 to Week 100)|"Starting at week 24 through week 52, participants were evaluated monthly to receive either the 2 mg Intravitreal Aflibercept Injection (IAI) PRN or sham injection according to the protocol re-treatment criteria as assessed by the masked physician. If none of the re-treatment criteria were met, participants received a sham injection.~From Week 52 to 100, participants were evaluated every three months, but could receive injections of IAI up to monthly if re-treatment criteria were met; sham injections were not given. Participants were observed from Week 24 to Week 100. Participants in the safety population that completed Week 24 were at risk."
954713|NCT00943072|E2|Reported Event|Sham Treatment (Baseline to Week 24)|Participants received sham treatment every 4 weeks from Baseline (Day 1) to Week 20. Participants were observed until Week 24. Participants in the safety population were at risk.
954714|NCT00943072|E1|Reported Event|Intravitreal Aflibercept Injection (IAI) (Baseline to Week 24)|"Participants received a 2 mg Intravitreal Aflibercept Injection (IAI) every 4 weeks (2Q4) from Baseline (Day 1) to Week 20. Participants were observed until Week 24.~Participants in the safety population were at risk."
954715|NCT00942994|B3|Baseline|Total|Total of all reporting groups
954716|NCT00942994|B2|Baseline|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954717|NCT00942994|B1|Baseline|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954718|NCT00942994|P2|Participant Flow|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954719|NCT00942994|P1|Participant Flow|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954720|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954721|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954722|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954723|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954837|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954727|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954728|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954729|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954730|NCT00942994|O2|Outcome|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954731|NCT00942994|O1|Outcome|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954732|NCT00942994|E2|Reported Event|Aliskiren / Amlodipine|At week 0 patients were randomized to amlodipine 5 mg. At week 1, patients were force titrated to aliskiren/amlodipine 150/5 mg. At week 2, patients were force titrated to aliskiren/amlodipine 300/5 mg. At week 4, patients were force titrated to aliskiren/amlodipine 300/10 mg.
954733|NCT00942994|E1|Reported Event|Aliskiren / Amlodipine / HCTZ|At week 0 patients were randomized to aliskiren/amlodipine 150/5 mg. At week 1, patients were force titrated to aliskiren/amlodipine/HCTZ 150/5/12.5 mg. At week 2, patients were force titrated to aliskiren/amlodipine/HCTZ 300/5/25 mg. At week 4, patients were force titrated to aliskiren/amlodipine/HCTZ 300/10/25 mg.
954734|NCT00942968|B1|Baseline|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954735|NCT00942968|P1|Participant Flow|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954736|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954737|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954738|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954739|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954740|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954741|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954742|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954743|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954744|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954745|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954746|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954747|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954748|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954838|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954749|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954750|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954868|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954751|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954752|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954753|NCT00942968|O1|Outcome|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954754|NCT00942968|E1|Reported Event|Dalteparin Sodium|Participants received subcutaneous (SC) injection of dalteparin sodium 200 international units per kilogram (IU/kg) once daily (QD) from Week 1-4 followed by SC injection of dalteparin sodium 150 IU/kg QD from Week 5-52.
954755|NCT00942903|B1|Baseline|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
954756|NCT00942903|P1|Participant Flow|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
954757|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
954758|NCT00942903|O1|Outcome|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
954759|NCT00942903|E1|Reported Event|Provox XtraHME|A group oflaryngectomized patients who normally use a Provox HME, converted to Provox XtraHME for a period of 3 weeks
954760|NCT00942851|B3|Baseline|Total|Total of all reporting groups
954761|NCT00942851|B2|Baseline|Placebo|topical intervention WITHOUT AH-8
954762|NCT00942851|B1|Baseline|Active|AH-8 containing topical intervention
954763|NCT00942851|P2|Participant Flow|Placebo|"Topical intervention agent WITHOUT AH-8. Identically appearing cream without the active ingredient.~Twice daily application to the eyelids in standardized fashion."
954764|NCT00942851|P1|Participant Flow|Active|Topical intervention agent containing AH8 0.005% Twice daily application to the eyelids in standardized fashion.
954765|NCT00942851|O2|Outcome|Placebo|topical intervention WITHOUT AH-8
954766|NCT00942851|O1|Outcome|Active|AH-8 containing topical intervention
954767|NCT00942851|O2|Outcome|Placebo|
954768|NCT00942851|O1|Outcome|Active Ingredient- AH8|
954769|NCT00942851|O2|Outcome|Placebo|subjects receiving placebo intervention, ie identically-appearing topical cream without AH-8 content
954770|NCT00942851|O1|Outcome|Active Ingredient- AH8|subjects receiving active intervention, ie topical cream containing 0.005% AH-8
954771|NCT00942851|E2|Reported Event|Placebo|topical intervention WITHOUT AH-8
954772|NCT00942851|E1|Reported Event|Active|AH-8 containing topical intervention
954773|NCT00942825|B3|Baseline|Total|Total of all reporting groups
954774|NCT00942825|B2|Baseline|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
954775|NCT00942825|B1|Baseline|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
954776|NCT00942825|P2|Participant Flow|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
954777|NCT00942825|P1|Participant Flow|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
954778|NCT00942825|O2|Outcome|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
954779|NCT00942825|O1|Outcome|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
954839|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954840|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954780|NCT00942825|E2|Reported Event|B Cisplatin + Pemetrexed|"Cisplatin + Pemetrexed~Cisplatin + Pemetrexed: Pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
955062|NCT00941733|P1|Participant Flow|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
954781|NCT00942825|E1|Reported Event|A CBP501 +Cisplatin + Pemetrexed|"CBP501 25 mg/m2 + Cisplatin 75 mg/m2 + Pemetrexed 500mg/m2~CBP501 + Cisplatin + Pemetrexed: CBP501, pemetrexed and cisplatin will be administered on the same day (Day 1), every 3 weeks for a maximum of six cycles. A cycle is considered to be 3 weeks (21 days).~CBP501 25 mg/m² will be administered as an i.v. infusion of 1 hour.~Pemetrexed 500 mg/m² will be administered as an i.v. infusion over 10 minutes, immediately after the CBP501 infusion.~Cisplatin 75 mg/m² will be administered as a 1-hour i.v. infusion immediately after the pemetrexed infusion."
954782|NCT00942786|B1|Baseline|One Arm|consecutive patients presenting for emergent non-cardiac surgery
954783|NCT00942786|P1|Participant Flow|No Treatment|Consecutive patients undergoing emergency surgery
954784|NCT00942786|O2|Outcome|Patients Not Sustaining Adverse Events|Subjects who did not reach the primary endpoint
954785|NCT00942786|O1|Outcome|Patients Sustaining Adverse Events|Subjects who reached the primary endpoint
954786|NCT00942786|O1|Outcome|All Patients|Consecutive patients undergoing emergent non-cardiac surgery
954787|NCT00942786|O1|Outcome|No Treatment|Consecutive patients undergoing emergency surgery
954788|NCT00942786|E1|Reported Event|One Arm|"consecutive patients presenting for emergent non-cardiac surgery~Patients were followed for occurence of major adverse cardiac events"
954789|NCT00942734|B1|Baseline|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
954790|NCT00942734|P1|Participant Flow|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
954791|NCT00942734|O1|Outcome|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
954792|NCT00942734|E1|Reported Event|RAD001 + Erlotinib|RAD001 5 mg orally and Erlotinib 150 mg orally every day of each 28 day study cycle.
954793|NCT00942604|B3|Baseline|Total|Total of all reporting groups
954794|NCT00942604|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
954795|NCT00942604|B1|Baseline|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
954796|NCT00942604|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
954797|NCT00942604|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
954798|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
954799|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
954800|NCT00942604|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
954801|NCT00942604|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
954802|NCT00942604|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 2 consecutive days
954803|NCT00942604|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
954804|NCT00942448|B5|Baseline|Total|Total of all reporting groups
954805|NCT00942448|B4|Baseline|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
954806|NCT00942448|B3|Baseline|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954807|NCT00942448|B2|Baseline|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954808|NCT00942448|B1|Baseline|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954809|NCT00942448|P4|Participant Flow|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
954810|NCT00942448|P3|Participant Flow|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954811|NCT00942448|P2|Participant Flow|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954812|NCT00942448|P1|Participant Flow|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954813|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
954814|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954815|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954816|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954817|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954818|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954819|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954820|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954821|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954822|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954823|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954824|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954825|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954826|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954827|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954828|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954829|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954830|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954831|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954832|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954833|NCT00942448|O4|Outcome|Placebo s.c. 1ml|
954834|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|
954835|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|
954836|NCT00942448|O1|Outcome|Diclofenac HPBCD s.c. 25mg/ml|
954865|NCT00942448|O4|Outcome|Placebo s.c. (1ml)|Placebo s.c. : 1 single injection at day of dental surgical extraction
954866|NCT00942448|O3|Outcome|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954867|NCT00942448|O2|Outcome|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954870|NCT00942448|E3|Reported Event|Diclofenac HPBCD s.c. 75mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954871|NCT00942448|E2|Reported Event|Diclofenac HPBCD s.c. 50mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954872|NCT00942448|E1|Reported Event|Diclofenac HPBCD s.c. 25mg/ml|Diclofenac HPBCD : 1 single injection at day of dental surgical extraction
954873|NCT00942422|B1|Baseline|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal). Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
954874|NCT00942422|P1|Participant Flow|Defined Green Tea Catechin Extract / Correlative Analysis|Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
954875|NCT00942422|O1|Outcome|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~defined green tea catechin extract: Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
954876|NCT00942422|E1|Reported Event|Defined Green Tea Catechin Extract / Correlative Analysis|"Polyphenon E, an oral capsule form of EGCG extracted from green tea, 800 mg administered daily on an empty stomach (at least 1 hour before or 2 hrs after a meal)Patients receive oral green tea catechin extract (Polyphenon E) daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~gene expression analysis: Blood and bone marrow samples will be obtained prior to the start of treatment and at the conclusion of the study for correlative studies. An additional peripheral blood sample will be obtained on day 8 of the"
954877|NCT00942409|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
954878|NCT00942409|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
954879|NCT00942409|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
954880|NCT00942409|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
954881|NCT00942266|B3|Baseline|Total|Total of all reporting groups
954882|NCT00942266|B2|Baseline|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954883|NCT00942266|B1|Baseline|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954884|NCT00942266|P2|Participant Flow|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954885|NCT00942266|P1|Participant Flow|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954906|NCT00942175|B1|Baseline|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
954886|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954908|NCT00942175|P3|Participant Flow|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
955063|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
954887|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954888|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954889|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954890|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954891|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954892|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954893|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954894|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954895|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954896|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954897|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954898|NCT00942266|O2|Outcome|Arm II: High-dose Vorinostat|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954899|NCT00942266|O1|Outcome|Arm I: Low-dose Vorinostat|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954900|NCT00942266|E2|Reported Event|Arm II|"Patients receive high-dose oral vorinostat once daily on days 1-3 and leucovorin calcium and fluorouracil as in arm I. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954901|NCT00942266|E1|Reported Event|Arm I|"Patients receive low-dose oral vorinostat once daily on days 1-3, leucovorin calcium IV over 2 hours on day 2, and fluorouracil IV over 46 hours on days 2 and 3. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~fluorouracil: Given IV~leucovorin calcium: Given IV~vorinostat: Given orally~pharmacological study: Correlative study"
954902|NCT00942175|B5|Baseline|Total|Total of all reporting groups
954903|NCT00942175|B4|Baseline|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
954904|NCT00942175|B3|Baseline|PPI Group 3|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen D: Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days."
954905|NCT00942175|B2|Baseline|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
955049|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
954907|NCT00942175|P4|Participant Flow|PPI Group 4|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen E: Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days."
954954|NCT00942175|E5|Reported Event|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954909|NCT00942175|P2|Participant Flow|PPI Group 2|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen C: Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days."
954910|NCT00942175|P1|Participant Flow|PPI Group 1|"Regimen A: Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.~Regimen B: Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days."
954911|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
954912|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954913|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
954914|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954915|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
954916|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954917|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
954918|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954919|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
954920|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954921|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
954922|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954923|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
954924|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954925|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
954926|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954927|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
954928|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954929|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
954930|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954931|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
954932|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954933|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
954934|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954935|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
954936|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954937|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
954938|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954939|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
954940|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954941|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
954942|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954943|NCT00942175|O8|Outcome|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
954944|NCT00942175|O7|Outcome|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954945|NCT00942175|O6|Outcome|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
954946|NCT00942175|O5|Outcome|PPI Group 3: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954947|NCT00942175|O4|Outcome|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
954948|NCT00942175|O3|Outcome|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954949|NCT00942175|O2|Outcome|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
954950|NCT00942175|O1|Outcome|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
955866|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
954951|NCT00942175|E8|Reported Event|PPI Group 4: Regimen E|Clopidogrel 75 mg, tablets, orally, once daily and Esomeprazole 40 mg, capsules, orally, once daily for up to 9 days.
954952|NCT00942175|E7|Reported Event|PPI Group 4: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954953|NCT00942175|E6|Reported Event|PPI Group 3: Regimen D|Clopidogrel 75 mg, tablets, orally, once daily and Omeprazole 80 mg, capsules, orally, once daily for up to 9 days.
954955|NCT00942175|E4|Reported Event|PPI Group 2: Regimen C|Clopidogrel 75 mg, tablets, orally, once daily and Dexlansoprazole 60 mg, capsules, orally, once daily for up to 9 days.
954956|NCT00942175|E3|Reported Event|PPI Group 2: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954957|NCT00942175|E2|Reported Event|PPI Group 1: Regimen B|Clopidogrel 75 mg, tablets, orally, once daily and Lansoprazole 30 mg, capsules, orally, once daily for up to 9 days.
954958|NCT00942175|E1|Reported Event|PPI Group 1: Regimen A|Clopidogrel 75 mg, tablets, orally, once daily for up to 9 days.
954959|NCT00942149|B1|Baseline|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
954960|NCT00942149|P1|Participant Flow|Daptomycin Cohort|There were 20 participants enrolled; each received a single 6 mg/kg dose of daptomycin IV.
954961|NCT00942149|O1|Outcome|Area Under the Curve - 24 Hours|pharmacokinetics of daptomycin
954962|NCT00942149|E1|Reported Event|Daptomycin Cohort|
954963|NCT00942084|B1|Baseline|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954964|NCT00942084|P1|Participant Flow|Acyclovir Study Enrollment|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954965|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954966|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954967|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954968|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954969|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954970|NCT00942084|O1|Outcome|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954971|NCT00942084|E1|Reported Event|Acyclovir Study Design|Two open-label PK studies contributed the data for this report. Version 1 was single-center and Version >=2 was multi-center. Acyclovir was administered intravenously as a 1-hour infusion for up to 3 days. Dosing in Study 1 was 500 mg/m2 every 8 hours. Dosing in Study 2 was determined by GA and PNA: 10 mg/kg every 12 hours (23-29 weeks GA and <14 days PNA); 20 mg/kg every 12 hours (23-29 weeks GA and 14-44 days PNA); and 20 mg/kg every 8 hours (30-34 weeks GA and <45 days PNA).
954972|NCT00941993|B1|Baseline|Iontophoretic Delivery of Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
954973|NCT00941993|P1|Participant Flow|Iontophoretic Delivery of Local Anesthesia|"Tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
954974|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
954975|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
954976|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
957418|NCT00934544|B3|Baseline|Total|Total of all reporting groups
954977|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent): Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
954978|NCT00941993|O1|Outcome|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
954979|NCT00941993|E1|Reported Event|Anesthesia|"tympanic membrane anesthesia delivery system~Iontophoresis System (Acclarent) : Iontophoresis system will deliver iontophoresis simultaneously to both ears. Active elements of this drug delivery system are lidocaine and epinephrine."
954980|NCT00941928|B1|Baseline|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
954981|NCT00941928|P1|Participant Flow|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
954982|NCT00941928|O1|Outcome|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
954983|NCT00941928|E1|Reported Event|Haploidentical NK Cells + Epratuzumab|Haploidentical donor-derived NK cell infusion, Epratuzumab 360 mg/m^2 once a day by vein (IV) on Day -4, Day -1 and Days 3, 6, 10, 13 and 17, and low-dose interleukin-2 (IL-2) Subcutaneous injections three times a week for 9 doses on Days 0 to 21; Fludarabine 25 mg/m^2 once a day IV on Day -6 through Day -2 over 30 minutes; Cyclophosphamide 60 mg/kg once a day IV on Days -5 and -4 over 2 hours.
954984|NCT00941889|B3|Baseline|Total|Total of all reporting groups
954985|NCT00941889|B2|Baseline|Gardasil|Patients in this group received Gardasil injection at initial date, 2 months and 6 months after enrollment.
954986|NCT00941889|B1|Baseline|Placebo|Patients in this group received placebo of saline at initial date, 2 months and 6 months after enrollment.
954987|NCT00941889|P2|Participant Flow|Gardasil Group|The treatment group will receive a 0.5 mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
954988|NCT00941889|P1|Participant Flow|Placebo|Patients who are in the control group will receive a placebo of saline at initial date, 2 months and 6 months.
954989|NCT00941889|O2|Outcome|Gardasil Group|Patients who received Gardasil injection at initial visit, 2 months, and 6 months after enrollment.
954990|NCT00941889|O1|Outcome|Placebo Group|Patients who received placebo of saline at initial visit, 2 months and 6 months after enrollment.
954991|NCT00941889|E2|Reported Event|Treatment Group|The treatment group received a 0.5mL intramuscular injection of Gardasil (quadrivalent HPV vaccine) in their upper extremity and again at two months and six months after enrollment.
954992|NCT00941889|E1|Reported Event|Placebo|Patients who are in the control group received a placebo of saline at initial date, 2 months and 6 months.
954993|NCT00941863|B6|Baseline|Total|Total of all reporting groups
954994|NCT00941863|B5|Baseline|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
954995|NCT00941863|B4|Baseline|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
954996|NCT00941863|B3|Baseline|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
954997|NCT00941863|B2|Baseline|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
954998|NCT00941863|B1|Baseline|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
954999|NCT00941863|P5|Participant Flow|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
955000|NCT00941863|P4|Participant Flow|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
955001|NCT00941863|P3|Participant Flow|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
955002|NCT00941863|P2|Participant Flow|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
955003|NCT00941863|P1|Participant Flow|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
955004|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
955050|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955051|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955052|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955005|NCT00941863|O1|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
955006|NCT00941863|O1|Outcome|Sorafenib 400 mg (Excluding Expansion)|Dose-escalation cohorts 3 and 4
955009|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
955010|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
955011|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
955012|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
955013|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
955014|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
955015|NCT00941863|O6|Outcome|Sorafenib 400 mg (Expansion, Treatment Continued After PCD)|25 of 119 participants from the Expansion Phase, were still on the treatment as of 31 May 2005. Of these, 6 subjects were continuing to receive sorafenib in combination with carboplatin and/or paclitaxel and 19 subjects were receiving single-agent sorafenib. The responses reported in these participants were from start of treatment until 18 Sep 2008.
955016|NCT00941863|O5|Outcome|Sorafenib 400 mg (Expansion, Treatment Until PCD)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
955017|NCT00941863|O4|Outcome|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
955018|NCT00941863|O3|Outcome|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
955019|NCT00941863|O2|Outcome|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
955020|NCT00941863|O1|Outcome|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
955021|NCT00941863|O1|Outcome|Sorafenib, Dose Escalation 100 mg Bid, 200 mg Bid, 400 mg Bid|All participants of escalation cohorts 1, 2, 3 and 4. (Sorafenib, dose escalation 100 mg bid [twice daily], 200 mg bid, 400 mg bid including 50 tablet and 200 tablet)
955022|NCT00941863|E5|Reported Event|Sorafenib 400 mg (Expansion)|Dose-expansion cohort: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet) expansion
955023|NCT00941863|E4|Reported Event|Sorafenib 400 mg (200-mg Tablet)|Dose-escalation cohort 4: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (200-mg tablet)
955024|NCT00941863|E3|Reported Event|Sorafenib 400 mg (50-mg Tablet)|Dose-escalation cohort 3: Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (50-mg tablet)
955025|NCT00941863|E2|Reported Event|Sorafenib 200 mg (50-mg Tablet)|Dose-escalation cohort 2: Sorafenib (Nexavar, BAY43-9006) 200 mg twice daily (50-mg tablet)
955026|NCT00941863|E1|Reported Event|Sorafenib 100 mg (50-mg Tablet)|Dose-escalation cohort 1: Sorafenib (Nexavar, BAY43-9006) 100 mg twice daily (50-mg tablet)
955027|NCT00941798|B3|Baseline|Total|Total of all reporting groups
955028|NCT00941798|B2|Baseline|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955029|NCT00941798|B1|Baseline|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955030|NCT00941798|P2|Participant Flow|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955031|NCT00941798|P1|Participant Flow|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955032|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955033|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955034|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955035|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955036|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955037|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955038|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955039|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955040|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955041|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955042|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955043|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955044|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955045|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955046|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955047|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955048|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955053|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955054|NCT00941798|O2|Outcome|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955055|NCT00941798|O1|Outcome|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955056|NCT00941798|E2|Reported Event|Mometasone Twisthaler®|Mometasone Twisthaler®, 400 µg QD
955057|NCT00941798|E1|Reported Event|QMF149 Twisthaler® 500/400|QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
955058|NCT00941733|B3|Baseline|Total|Total of all reporting groups
955064|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955065|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955066|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955067|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955068|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955069|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955070|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955071|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955072|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955073|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955074|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955075|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955076|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955077|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955078|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955079|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955080|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955081|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955082|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955083|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955084|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955085|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955086|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955087|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955088|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955089|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955090|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955091|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955092|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955093|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955094|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955095|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955096|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955097|NCT00941733|O2|Outcome|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955098|NCT00941733|O1|Outcome|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955099|NCT00941733|E2|Reported Event|Standard PTA|Standard PTA balloon: Balloon Angioplasty
955100|NCT00941733|E1|Reported Event|Drug Eluting Balloon|IN.PACT Amphirion: Balloon Angioplasty
955101|NCT00941720|B1|Baseline|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
955102|NCT00941720|P1|Participant Flow|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
955103|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
955104|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
955105|NCT00941720|O1|Outcome|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
955106|NCT00941720|E1|Reported Event|Busulfan Treatment|"busulfan: IV busulfan 0.8 mg/kg every 6 hours x 16 doses~cyclophosphamide: IV cyclophosphamide 60 mg/kg over 4 hours x 2 days~autologous hematopoietic stem cell transplantation: infusion of autologous hematopoietic stem cells of at least 2.0 x 106 CD34+ cells/kg on day 0"
955107|NCT00941681|B4|Baseline|Total|Total of all reporting groups
955867|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955108|NCT00941681|B3|Baseline|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955109|NCT00941681|B2|Baseline|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955110|NCT00941681|B1|Baseline|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955111|NCT00941681|P3|Participant Flow|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955112|NCT00941681|P2|Participant Flow|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955113|NCT00941681|P1|Participant Flow|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955114|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955115|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955116|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955117|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955118|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955119|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955120|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955121|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955122|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955123|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955124|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955125|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955126|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955127|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955128|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955129|NCT00941681|O3|Outcome|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955130|NCT00941681|O2|Outcome|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955131|NCT00941681|O1|Outcome|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955132|NCT00941681|E3|Reported Event|Cohort 3: MR 100 mg BID|Modified-release (MR) 100 mg dose of CK-1827452 twice a day (BID) for 10 days
955133|NCT00941681|E2|Reported Event|Cohort 2: IR 37.5 mg TID|Immediate-release (IR) 37.5 mg dose of CK-1827452 three times a day (TID) for 10 days.
955134|NCT00941681|E1|Reported Event|Cohort 1: MR 50 mg BID|Modified-release (MR) 50 mg dose of CK-1827452 twice a day (BID) for 10 days.
955135|NCT00941668|B3|Baseline|Total|Total of all reporting groups
955136|NCT00941668|B2|Baseline|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
955137|NCT00941668|B1|Baseline|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
955138|NCT00941668|P2|Participant Flow|Colgate Great Regular Flavor (Placebo)|sodium monofluorophosphate toothpaste
955139|NCT00941668|P1|Participant Flow|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
955140|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
955141|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
955142|NCT00941668|O2|Outcome|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
955143|NCT00941668|O1|Outcome|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
955144|NCT00941668|E2|Reported Event|Colgate Cavity Protection (Placebo)|sodium monofluorophosphate toothpaste
955145|NCT00941668|E1|Reported Event|Total Toothpaste (Active)|triclosan/copolymer/fluoride toothpaste
955146|NCT00941655|B3|Baseline|Total|Total of all reporting groups
955147|NCT00941655|B2|Baseline|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
955148|NCT00941655|B1|Baseline|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
955149|NCT00941655|P2|Participant Flow|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
955150|NCT00941655|P1|Participant Flow|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
955151|NCT00941655|O1|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
955856|NCT00939107|E1|Reported Event|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
955152|NCT00941655|O2|Outcome|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
955153|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
955154|NCT00941655|O1|Outcome|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
955155|NCT00941655|E2|Reported Event|Systemic Chemotherapy Alone|Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours.
955156|NCT00941655|E1|Reported Event|Surgery + HIPEC + Systemic Chemotherapy|"Surgery -gastric resection, metastasectomy, and heated intraperitoneal chemotherapy with Fluouracil (5-FU) 400 mg/m^2 intravenous (IV) over 5 minutes. Leucovorin 20 mg/m^2 IV and Oxaliplatin 460 mg/m^2 diluted in 2.0 L/m^2 of dextrose 5% in water (D5W) given as a heated intraperitoneal perfusion.~Systemic chemotherapy - Irinotecan 165 mg/m^2 IV over 90 minutes, Oxaliplatin 85 mg/m^2 over 120 minutes, Leucovorin 200 mg/m^2 IV 120 minutes, 5FU 3200 mg/m^2 continuous IV infusion over 48 hours."
955157|NCT00941603|B7|Baseline|Total|Total of all reporting groups
955158|NCT00941603|B6|Baseline|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
955159|NCT00941603|B5|Baseline|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955160|NCT00941603|B4|Baseline|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955161|NCT00941603|B3|Baseline|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955162|NCT00941603|B2|Baseline|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955163|NCT00941603|B1|Baseline|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955164|NCT00941603|P6|Participant Flow|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
955165|NCT00941603|P5|Participant Flow|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955166|NCT00941603|P4|Participant Flow|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955167|NCT00941603|P3|Participant Flow|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955168|NCT00941603|P2|Participant Flow|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955169|NCT00941603|P1|Participant Flow|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955170|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
955171|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955172|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955173|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955174|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955175|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955176|NCT00941603|O6|Outcome|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
955177|NCT00941603|O5|Outcome|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955178|NCT00941603|O4|Outcome|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955179|NCT00941603|O3|Outcome|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955180|NCT00941603|O2|Outcome|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955181|NCT00941603|O1|Outcome|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955182|NCT00941603|E6|Reported Event|Placebo|Participants receive two placebo tablets once daily in the morning with water in a fasted state for 8 weeks
955183|NCT00941603|E5|Reported Event|SCH 900271 1 mg|Participants receive SCH 900271 1 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955184|NCT00941603|E4|Reported Event|SCH 900271 2.5 mg|Participants receive SCH 900271 2.5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955857|NCT00939094|B3|Baseline|Total|Total of all reporting groups
955185|NCT00941603|E3|Reported Event|SCH 900271 5 mg|Participants receive SCH 900271 5 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955186|NCT00941603|E2|Reported Event|SCH 900271 10 mg|Participants receive SCH 900271 10 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955187|NCT00941603|E1|Reported Event|SCH 900271 15 mg|Participants receive SCH 900271 15 mg tablet and placebo tablet once daily in the morning with water in a fasted state for 8 weeks
955188|NCT00941330|B3|Baseline|Total|Total of all reporting groups
955189|NCT00941330|B2|Baseline|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
955190|NCT00941330|B1|Baseline|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
955234|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955191|NCT00941330|P2|Participant Flow|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
955192|NCT00941330|P1|Participant Flow|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
955193|NCT00941330|O2|Outcome|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
955194|NCT00941330|O1|Outcome|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
955195|NCT00941330|O2|Outcome|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
955196|NCT00941330|O1|Outcome|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
955197|NCT00941330|E2|Reported Event|B: Docetaxel and Cytoxan|"ARM B: Patients will be treated with docetaxel and cytoxan.~Docetaxel: Docetaxel (75 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks).~Cytoxan: Cytoxan (600 mg/m²) into a vein once every 3 weeks for 6 cycles (6 times in about 24 weeks)."
955198|NCT00941330|E1|Reported Event|A: Exemestane|"ARM A: Patients will be treated with exemestane.~Exemestane: 25 mg daily by mouth for 6 to 12 months."
955199|NCT00941304|B6|Baseline|Total|Total of all reporting groups
955200|NCT00941304|B5|Baseline|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955201|NCT00941304|B4|Baseline|Placebo|Placebo oral capsule and 2 placebo buccal films
955202|NCT00941304|B3|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955203|NCT00941304|B2|Baseline|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955204|NCT00941304|B1|Baseline|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955205|NCT00941304|P5|Participant Flow|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955206|NCT00941304|P4|Participant Flow|Placebo|Placebo oral capsule and 2 placebo buccal films
955207|NCT00941304|P3|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955208|NCT00941304|P2|Participant Flow|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955209|NCT00941304|P1|Participant Flow|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine hydrochloride (HCl) buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955210|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955211|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955212|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955213|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955214|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955215|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955216|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955217|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955218|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955219|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955220|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955221|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955222|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955223|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955224|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955225|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955226|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955227|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955228|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955229|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955230|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955231|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955232|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955233|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955235|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955236|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955237|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955238|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955239|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955240|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955241|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955242|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955243|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955244|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955245|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955246|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955247|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955248|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955249|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955250|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955251|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955252|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955253|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955254|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955255|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955256|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955257|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955258|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955259|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955260|NCT00941304|O5|Outcome|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955261|NCT00941304|O4|Outcome|Placebo|Placebo oral capsule and 2 placebo buccal films
955262|NCT00941304|O3|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955263|NCT00941304|O2|Outcome|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955264|NCT00941304|O1|Outcome|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955265|NCT00941304|E5|Reported Event|Oxycodone 5 mg|Oxycodone 5-mg oral capsule and 2 placebo buccal films
955266|NCT00941304|E4|Reported Event|Placebo|Placebo oral capsule and 2 placebo buccal films
955267|NCT00941304|E3|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M1|Buprenorphine HCl buccal film 0.5-mg modified formulation 1, placebo buccal film, and placebo oral capsule
955268|NCT00941304|E2|Reported Event|0.5-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.5-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955269|NCT00941304|E1|Reported Event|0.25-mg Buprenorphine HCl Buccal Film, M2|Buprenorphine HCl buccal film 0.25-mg modified formulation 2, placebo buccal film, and placebo oral capsule
955302|NCT00941031|O1|Outcome|Maintenance Fixed Interval|Fixed-time interval regimen – “FI”: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
955303|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
955858|NCT00939094|B2|Baseline|2 - Placebo|Placebo, capsule
955270|NCT00941070|B1|Baseline|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955310|NCT00941031|E7|Reported Event|MAINTENANCE: Open Label|MAINTENANCE: Open label Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.
955311|NCT00941031|E6|Reported Event|MAINTENANCE: Start of Relapse|MAINTENANCE: Treatment at start of relapse regimen - 'SR'
955312|NCT00941031|E5|Reported Event|MAINTENANCE: Fixed Interval|MAINTENANCE: Fixed-time interval regimen - 'FI'
955271|NCT00941070|P1|Participant Flow|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955272|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955273|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955274|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955275|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955276|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955277|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955278|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955304|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
955305|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
955859|NCT00939094|B1|Baseline|A - AZD2066|AZD2066, 12 mg capsule
955279|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955280|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955281|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955282|NCT00941070|O1|Outcome|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955283|NCT00941070|E1|Reported Event|Treatment (Cisplatin, Triapine, Radiation Therapy)|"Patients receive cisplatin IV over 90 minutes on days 2, 9, 16, 23, and 30 and triapine IV on days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, 29, 31, and 33. Patients also undergo pelvic external beam radiotherapy 5 days a week during weeks 1-5. Patients may undergo parametrial boost radiation and intracavitary low-dose or high-dose rate brachytherapy as clinically indicated.~Patients undergo whole-body F-18 fluorodeoxyglucose-PET/CT imaging at baseline, at 3 months after completion of study treatment, and at disease progression. Patients complete Sexual Function-Vaginal Changes Questionnaire and a smoking behavior questionnaire at baseline, at 3 months after completion of study treatment, and at disease progression."
955284|NCT00941031|B5|Baseline|Total|Total of all reporting groups
955285|NCT00941031|B4|Baseline|Placebo|
955286|NCT00941031|B3|Baseline|Induction Early Loading Dose|
955287|NCT00941031|B2|Baseline|Induction Monthly Dose|
955288|NCT00941031|B1|Baseline|Induction Single Dose|Baseline through Week 12
955289|NCT00941031|P7|Participant Flow|Open Label|"Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase - OL: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29"
955290|NCT00941031|P6|Participant Flow|Start of Relapse|"Treatment at start of relapse regimen - SR: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
955291|NCT00941031|P5|Participant Flow|Fixed Interval|"Fixed-time interval regimen - FI: secukinumab (AIN457) 150 mg s.c. administered at Week 13 and at Week 25 and placebo at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29"
955292|NCT00941031|P4|Participant Flow|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
955293|NCT00941031|P3|Participant Flow|Induction Early Loading|"Early loading induction - Early: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12"
955294|NCT00941031|P2|Participant Flow|Induction Monthly Dose|"Induction with monthly injections - Monthly: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12"
955295|NCT00941031|P1|Participant Flow|Induction Single Dose|"Induction with single injection - Single: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12"
955296|NCT00941031|O4|Outcome|Placebo Dose|Placebo administered at weeks 1, 2, 3, 5, 9, Baseline through Week 12
955297|NCT00941031|O3|Outcome|Induction Early Loading Dose|Early loading induction – “Early”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 2, 3, 5, Baseline through Week 12
955298|NCT00941031|O2|Outcome|Induction Monthly Dose|Induction with monthly injections – “Monthly”: secukinumab (AIN457) 150 mg s.c. administered at weeks 1, 5, 9, Baseline through Week 12
955299|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
955300|NCT00941031|O3|Outcome|Maintenance Open Label|Non responders and partial responders at Week 13 and patients who experienced 2 consecutive relapses at scheduled visits from Week 13 onwards were eligible to enter the Open Label phase – “OL”: secukinumab (AIN457) 150 mg s.c. administered every 4 weeks.21 to Week 29
955301|NCT00941031|O2|Outcome|Maintenance Start of Relapse|Treatment at start of relapse regimen – “SR”: Placebo administered at Week 13 and possibly at Week 25 if no start of relapse observed, and secukinumab (AIN457) 150 mg s.c. administered at regular scheduled visit at which a start of relapse was observed, Week 21 to Week 29
955860|NCT00939094|P2|Participant Flow|2 - Placebo|Placebo, capsule
955306|NCT00941031|O1|Outcome|Induction Single Dose|Induction with single injection – “Single”: secukinumab (AIN457) 150 mg s.c. administered at Week 1, Baseline through Week 12
955307|NCT00941031|E10|Reported Event|FOLLOW-UP: Open Label|FOLLOW-UP: Open label
955308|NCT00941031|E9|Reported Event|FOLLOW-UP: Start of Relapse|FOLLOW-UP: Treatment at start of relapse regimen - 'SR'
955309|NCT00941031|E8|Reported Event|FOLLOW-UP: Fixed Interval|FOLLOW-UP: Fixed-time interval regimen - 'FI'
955313|NCT00941031|E4|Reported Event|INDUCTION: Placebo|INDUCTION: Placebo - 'Placebo'
955314|NCT00941031|E3|Reported Event|INDUCTION: Early|INDUCTION: with single injection - 'Single'
955315|NCT00941031|E2|Reported Event|INDUCTION: Monthly|INDUCTION: with monthly injections - 'Monthly'
955316|NCT00941031|E1|Reported Event|INDUCTION: Single|INDUCTION: Early loading induction - 'Early'
955317|NCT00940992|B4|Baseline|Total|Total of all reporting groups
955318|NCT00940992|B3|Baseline|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955319|NCT00940992|B2|Baseline|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
955320|NCT00940992|B1|Baseline|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955321|NCT00940992|P3|Participant Flow|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955322|NCT00940992|P2|Participant Flow|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
955323|NCT00940992|P1|Participant Flow|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955324|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955325|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
955326|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955327|NCT00940992|O3|Outcome|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955328|NCT00940992|O2|Outcome|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
955329|NCT00940992|O1|Outcome|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955330|NCT00940992|E3|Reported Event|DER 45 EV Gel, 5%|"DER 45 EV Gel, 5% applied topically once a day for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955331|NCT00940992|E2|Reported Event|Vehicle|"Placebo Gel applied topically once a day for 12 weeks~Vehicle: Topical application to face for 12 weeks"
955332|NCT00940992|E1|Reported Event|DER 45 EV Gel, 1%|"DER 45 EV Gel, 1% topically applied once daily to face for 12 weeks~DER 45 EV: Topical application to face for 12 weeks"
955333|NCT00940927|B1|Baseline|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
955334|NCT00940927|P1|Participant Flow|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
955335|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
955336|NCT00940927|O1|Outcome|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
955337|NCT00940927|E1|Reported Event|Albuterol|Increasing doses of albuterol by MDI and nebulizer solution
955338|NCT00940901|B3|Baseline|Total|Total of all reporting groups
955339|NCT00940901|B2|Baseline|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then sildenafil 50 mg for weeks 9-16.
955340|NCT00940901|B1|Baseline|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks
955341|NCT00940901|P2|Participant Flow|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
955342|NCT00940901|P1|Participant Flow|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
955343|NCT00940901|O2|Outcome|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
955344|NCT00940901|O1|Outcome|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
955345|NCT00940901|O2|Outcome|Placebo Then Sildenafil|Participants assigned to this arm were given a placebo pill for the first 8 weeks, and then Sildenafil 50 mg for weeks 9-16.
955346|NCT00940901|O1|Outcome|Sildenafil|Participants assigned to this arm were given sildenafil 50 mg tablet daily for 16 weeks.
955347|NCT00940901|E4|Reported Event|Placebo Then Sildenafil Phase 2|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
955348|NCT00940901|E3|Reported Event|Sildenafil Phase 2|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
955349|NCT00940901|E2|Reported Event|Placebo Then Sildenafil Phase 1|Participants taking placebo daily for weeks 1-8 during phase 1 then taking Sildenafil 50mg tablet daily for weeks 9-16 during phase 2
955350|NCT00940901|E1|Reported Event|Sildenafil Phase 1|Participants taking sildenafil 50 mg tablet daily for weeks 1-8 during Phase 1 and during weeks 9-16 during Phase 2
955351|NCT00940875|B3|Baseline|Total|Total of all reporting groups
955373|NCT00940576|P2|Participant Flow|Oral Intake of Placebo First, Then Mare´s Milk|Oral intake of 250 ml per day placebo first, then 250 ml per day mare´s milk
955352|NCT00940875|B2|Baseline|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955353|NCT00940875|B1|Baseline|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955354|NCT00940875|P2|Participant Flow|Gemcitabine (G) Plus (+) Erlotinib (E)|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, orally (PO), once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955384|NCT00940537|P1|Participant Flow|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
960122|NCT00927849|B4|Baseline|Total|Total of all reporting groups
955355|NCT00940875|P1|Participant Flow|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955356|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955357|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955358|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955359|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955360|NCT00940875|O2|Outcome|Gemcitabine+ Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955361|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955362|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955363|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955364|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955365|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955366|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955367|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955368|NCT00940875|O2|Outcome|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955369|NCT00940875|O1|Outcome|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955370|NCT00940875|E2|Reported Event|Gemcitabine + Erlotinib|Participants received gemcitabine, 1250 mg/m^2, IV, on Days 1 and 8 of Cycles 1-6 (28-day cycles). Participants also received erlotinib, 150 mg tablets, PO, once per day on Days 15-28 of Cycles 1-6 (28-day cycles); and 150 mg tablets, PO, once per day thereafter until disease progression, unacceptable toxicity, withdrawal, or study termination (12 months after randomization of the last participant).
955371|NCT00940875|E1|Reported Event|Gemcitabine Monotherapy|Participants received gemcitabine, 1000 mg/m^2, IV, on Days 1, 8, and 15 of Cycles 1-6 (28-day cycles). Participants consented to post-treatment survival follow-up received no further treatment.
955372|NCT00940576|B1|Baseline|All Study Participants|Oral intake of placebo first, then mare´s milk and oral intake of mare´s milk first, then placebo respectively.
955861|NCT00939094|P1|Participant Flow|A - AZD2066|AZD2066, 12 mg capsule
955374|NCT00940576|P1|Participant Flow|Oral Intake of Mare´s Milk First, Then Placebo|Oral Intake of 250 ml per day Mare´s Milk First, Then 250 ml per day Placebo
955375|NCT00940576|O2|Outcome|Patients Ulcerative Colitis|
955376|NCT00940576|O1|Outcome|Patients Crohn´s Disease|
955377|NCT00940576|O1|Outcome|Entire Study Population|oral intake of 250 ml mare´s milk or placebo drink daily
955378|NCT00940576|E2|Reported Event|Group 2|oral intake of 250 ml placebo daily
955379|NCT00940576|E1|Reported Event|Group 1|oral intake of 250 ml mare's milk daily
955380|NCT00940537|B3|Baseline|Total|Total of all reporting groups
955381|NCT00940537|B2|Baseline|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
955382|NCT00940537|B1|Baseline|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
955383|NCT00940537|P2|Participant Flow|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
955385|NCT00940537|O1|Outcome|All Subjects|all subjects studied. This includes both lean and obese subjects with a range of intrahepatic triglyceride.
955386|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
955387|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
955388|NCT00940537|O2|Outcome|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
955389|NCT00940537|O1|Outcome|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
955390|NCT00940537|E2|Reported Event|Non-NAFLD|Non-diabetic, obese with no previous diagnosis of NAFLD
955391|NCT00940537|E1|Reported Event|NAFLD|Non-diabetic, obese with diagnosed NAFLD (hepatic triglyceride content (HTGC) greater or equal to 5.5%)
955392|NCT00940485|B3|Baseline|Total|Total of all reporting groups
955393|NCT00940485|B2|Baseline|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955394|NCT00940485|B1|Baseline|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955395|NCT00940485|P2|Participant Flow|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955396|NCT00940485|P1|Participant Flow|Peginterferon Alfa-2a + Entecavir|Participants received PEGASYS® (peginterferon alfa-2a)180 micrograms (mcg) subcutaneously once weekly for 48 weeks, plus entecavir 0.5 milligram (mg) orally once daily for 8 weeks.
955397|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955398|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955399|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955400|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955401|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955402|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955403|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955404|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955405|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955406|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955407|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955408|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955409|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955410|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955411|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955412|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955413|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955414|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955415|NCT00940485|O2|Outcome|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955416|NCT00940485|O1|Outcome|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955417|NCT00940485|E2|Reported Event|Entecavir|Participants received entecavir 0.5 mg orally once daily for 48 weeks.
955418|NCT00940485|E1|Reported Event|Peginterferon Alfa-2a + Entecavir|Participants received peginterferon alfa-2a180 mcg subcutaneously once weekly for 48 weeks, plus entecavir 0.5 mg orally once daily for 8 weeks.
955419|NCT00940290|B5|Baseline|Total|Total of all reporting groups
955420|NCT00940290|B4|Baseline|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
955421|NCT00940290|B3|Baseline|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
955422|NCT00940290|B2|Baseline|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
955423|NCT00940290|B1|Baseline|GRADE System|A clinical recommendation built and graded with the GRADE working group system
955424|NCT00940290|P4|Participant Flow|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
955425|NCT00940290|P3|Participant Flow|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
955426|NCT00940290|P2|Participant Flow|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
955427|NCT00940290|P1|Participant Flow|GRADE System|A clinical recommendation built and graded with the GRADE working group system
955428|NCT00940290|O4|Outcome|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
955429|NCT00940290|O3|Outcome|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
955430|NCT00940290|O2|Outcome|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
955431|NCT00940290|O1|Outcome|GRADE System|A clinical recommendation built and graded with the GRADE working group system
955432|NCT00940290|E4|Reported Event|CEBM-Oxford|A clinical recommendation built and graded with the Centre for Evidence-Based Medicine grading system
955433|NCT00940290|E3|Reported Event|NICE Grading System|A clinical recommendation built and graded with National Institute of Clinical Excellence grading system
955434|NCT00940290|E2|Reported Event|SIGN Grading System|A clinical recommendation built and graded with the Scottish Intercollegiate Guidelines Network system
955435|NCT00940290|E1|Reported Event|GRADE System|A clinical recommendation built and graded with the GRADE working group system
955436|NCT00940108|B5|Baseline|Total|Total of all reporting groups
955437|NCT00940108|B4|Baseline|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955438|NCT00940108|B3|Baseline|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955439|NCT00940108|B2|Baseline|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955440|NCT00940108|B1|Baseline|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955441|NCT00940108|P4|Participant Flow|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955442|NCT00940108|P3|Participant Flow|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955443|NCT00940108|P2|Participant Flow|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955444|NCT00940108|P1|Participant Flow|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955445|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955446|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955447|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955448|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955449|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955450|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955451|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955452|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955453|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955454|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955696|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery (ESS) performed in physician's office (IO, or In Office) using balloon sinus dilation device.
955455|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955456|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955457|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955458|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955701|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955459|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955460|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955461|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955462|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955463|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955464|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955465|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955466|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955467|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955468|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955469|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955470|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955471|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955472|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955473|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955474|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955475|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955476|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955477|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955478|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955479|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955480|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955481|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955482|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955483|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955484|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955485|NCT00940108|O4|Outcome|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955486|NCT00940108|O3|Outcome|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955487|NCT00940108|O2|Outcome|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955488|NCT00940108|O1|Outcome|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955489|NCT00940108|E4|Reported Event|CSL425 (30 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955490|NCT00940108|E3|Reported Event|CSL425 (15 mcg) Cohort B|Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955491|NCT00940108|E2|Reported Event|CSL425 (30 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955492|NCT00940108|E1|Reported Event|CSL425 (15 mcg) Cohort A|Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
955493|NCT00940017|B1|Baseline|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955494|NCT00940017|P1|Participant Flow|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955495|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955496|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955497|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955498|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955499|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955500|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955517|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955862|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
955501|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955502|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955702|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955503|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955504|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955505|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955506|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955507|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955508|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955509|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955510|NCT00940017|O1|Outcome|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955511|NCT00940017|E1|Reported Event|Anidulafungin and Voriconazole|Anidulafungin (Eraxis™) intravenously (IV) in a loading dose of 200 milligrams (mg) on Day 1, followed by maintenance doses of 100 mg every 24 hours on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects received voriconazole (Vfend®) in a loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1, followed by a maintenance dose of 4 mg/kg every 12 hours on Day 2, and a 4 mg/kg morning dose on Day 3.
955512|NCT00939991|B3|Baseline|Total|Total of all reporting groups
955513|NCT00939991|B2|Baseline|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955514|NCT00939991|B1|Baseline|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
955515|NCT00939991|P2|Participant Flow|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955516|NCT00939991|P1|Participant Flow|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
955518|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955519|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955520|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955521|NCT00939991|O1|Outcome|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955522|NCT00939991|O1|Outcome|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
955523|NCT00939991|E2|Reported Event|Phase II|Bevacizumab is to be administered intravenously at 10 mg/kg every other week. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat is to be administered daily on days 1-7 and 15-21 of each 28 day cycle using the MTD from Phase I.
955524|NCT00939991|E1|Reported Event|Phase I Dose Escalation|Bevacizumab is to be administered intravenously at 10 mg/kg every other week starting on day 1. Temozolomide is to be administered on a continuous daily dosing schedule at 50 mg/m2/day. Vorinostat (200mg/dose or 400mg/dose) is to be administered daily on days 1-7 and 15-21 of each 28 day cycle. The dose of Vorinostat is escalated in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT) with at least two patients experiencing DLT at the next higher dose level.
955525|NCT00939952|B1|Baseline|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955526|NCT00939952|P1|Participant Flow|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955527|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955528|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955529|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955530|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955531|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955532|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955533|NCT00939952|O1|Outcome|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955534|NCT00939952|E1|Reported Event|Ertapenem 500 mg IV x1|All patients will receive ertapenem 500 mg IV once.
955535|NCT00939900|B3|Baseline|Total|Total of all reporting groups
955536|NCT00939900|B2|Baseline|Control|control group
955537|NCT00939900|B1|Baseline|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
955538|NCT00939900|P2|Participant Flow|Control|control group
955539|NCT00939900|P1|Participant Flow|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
955540|NCT00939900|O2|Outcome|Control|control group
955541|NCT00939900|O1|Outcome|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
955542|NCT00939900|E2|Reported Event|Control|control group
955543|NCT00939900|E1|Reported Event|Aclasta|"aclasta group~zoledronic acid (aclasta): Once-yearly administration of 5mg zoledronic acid intravenously (dosage of treatment of osteoporosis) (+ calcium:1,200mg/day, VitD:800IU/day) during study period"
955544|NCT00939874|B1|Baseline|Raltegravir|Raltegravir: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 48 weeks.
955545|NCT00939874|P1|Participant Flow|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
955546|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
955547|NCT00939874|O1|Outcome|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
955548|NCT00939874|E1|Reported Event|Raltegravir|Thirty seven adults receiving tenofovir (TDF) and a ritonavir-boosted protease inhibitor (r/PI) were switched from TDF to raltegravir (RAL) in this open-label, non-randomised trial. Raltegravir tablet 400mg was taken orally, twice daily for 48 weeks
955549|NCT00939809|B1|Baseline|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955550|NCT00939809|P1|Participant Flow|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955852|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
955551|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955552|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955553|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955554|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955881|NCT00939055|B2|Baseline|Sham Procedure|"No intervention~Sham procedure: False procedure"
955555|NCT00939809|O1|Outcome|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955556|NCT00939809|E1|Reported Event|A6 (Subcutaneous)|300 mg A6 Subcutaneously daily (2 injections of 150 mg) (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
955557|NCT00939796|B1|Baseline|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
955558|NCT00939796|P1|Participant Flow|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
955559|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
955560|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
955561|NCT00939796|O1|Outcome|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
955562|NCT00939796|E1|Reported Event|Tympanostomy Tube Delivery System (TTDS)|Tympanostomy tube placement with Acclarent tube delivery system
955563|NCT00939783|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
955564|NCT00939783|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
955565|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
955566|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
955567|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
955568|NCT00939783|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
955569|NCT00939783|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by 20 mg tablet orally three times a day. Treatment was administered until participant withdrawal or study termination.
955570|NCT00939731|B1|Baseline|Entire Study Population|Includes participants randomized to receive PF-02341066 250 mg IRT first and PF-02341066 250 mg PIC first.
955571|NCT00939731|P2|Participant Flow|PF-02341066 250 mg PIC First, Then PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg PIC in first intervention period; and single oral dose of PF-02341066 250 mg IRT in second intervention period. A washout period of at least 14 days was maintained between each period.
955572|NCT00939731|P1|Participant Flow|PF-02341066 250 mg IRT First, Then PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg immediate release tablet (IRT) in first intervention period; and single oral dose of PF-02341066 250 mg powder in capsule (PIC) in second intervention period. A washout period of at least 14 days was maintained between each period.
955573|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955574|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955575|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955576|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955577|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955578|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955579|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955580|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955581|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955582|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955583|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955584|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955585|NCT00939731|O2|Outcome|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955586|NCT00939731|O1|Outcome|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955587|NCT00939731|E2|Reported Event|PF-02341066 250 mg IRT|Single oral dose of PF-02341066 250 mg IRT (Treatment B [Test]) in either first intervention period or second intervention period.
955588|NCT00939731|E1|Reported Event|PF-02341066 250 mg PIC|Single oral dose of PF-02341066 250 mg PIC (Treatment A [Reference]) in either first intervention period or second intervention period.
955589|NCT00939705|B3|Baseline|Total|Total of all reporting groups
955590|NCT00939705|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
955591|NCT00939705|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
955592|NCT00939705|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
955593|NCT00939705|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
955594|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
955595|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
955596|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
955597|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
955598|NCT00939705|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
955599|NCT00939705|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
955600|NCT00939705|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.), to be administered at Hour 0 on Day 1 of each test period.
955601|NCT00939705|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited.Administered at Hour 0 on Day 1 of each test period.
955602|NCT00939692|B3|Baseline|Total|Total of all reporting groups
955603|NCT00939692|B2|Baseline|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
955604|NCT00939692|B1|Baseline|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
955605|NCT00939692|P2|Participant Flow|Topamax First, Then Torrent's Topiramate|"For period one - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg."
955606|NCT00939692|P1|Participant Flow|Torrent's Topiramate First, Then Topamax|"For period one - on the morning of Day 1 subjects received two tablets of the test formulation, Torrent's Topiramate 25 mg.~Followed by a 21 day washout period.~For period two - on the morning of Day 1 subjects received two tablets of the reference formulation, Topamax 25 mg."
955607|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
955608|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
955609|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
955610|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
955611|NCT00939692|O2|Outcome|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
955612|NCT00939692|O1|Outcome|Torrent's Topiramate|tablet containing 25 mg of topiramate
955613|NCT00939692|E2|Reported Event|Topamax|tablet containing 25 mg of topiramate (Topamax®, Ortho-McNeil Neurologics, Inc.)
955614|NCT00939692|E1|Reported Event|Torrent's Topiramate|tablet containing 25 mg of topiramate (Torrent Pharmaceuticals Limited)
955615|NCT00939627|B3|Baseline|Total|Total of all reporting groups
955616|NCT00939627|B2|Baseline|Arm B - Cetuximab and Sorafenib Tosylate|Patients receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
955617|NCT00939627|B1|Baseline|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
955618|NCT00939627|P3|Participant Flow|Participants Who Did Not Receive Treatment.|Placebo Arm: The protocol was amended and this arm was removed.
955619|NCT00939627|P2|Participant Flow|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
955620|NCT00939627|P1|Participant Flow|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility..
955621|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
955695|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery (ESS) performed in the operating room (OR) with or without balloon sinus dilation devices.
955863|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955622|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
955623|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
955624|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
955625|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
955626|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
955627|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
955628|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
955629|NCT00939627|O2|Outcome|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate 400 mg by mouth twice daily on days 1-21.
955630|NCT00939627|O1|Outcome|Arm A - Cetuximab|Patients were to receive cetuximab 400 mg/m^2 IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
955631|NCT00939627|E2|Reported Event|Arm B - Cetuximab and Sorafenib Tosylate|Patients received cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral sorafenib tosylate twice daily on days 1-21.
955632|NCT00939627|E1|Reported Event|Arm A - Cetuximab|Patients were to receive cetuximab IV over 60-120 minutes on days 1, 8, and 15 and oral placebo twice daily on days 1-21. After 19 patients were enrolled, the trial was amended to remove the placebo (and blinding) due to issues with placebo tablet solubility.
955633|NCT00939562|B1|Baseline|Entire Study Population|Includes subjects who received a single dose of one 100 mg doxycycline monohydrate tablet (Test) and a single dose of one 100 mg doxycycline carragenate tablet (Reference).
955634|NCT00939562|P2|Participant Flow|Doxycycline Carragenate, Then Doxycycline Monohydrate|Single dose of one 100 mg doxycycline carragenate tablet (Reference) during first period and single dose of one 100 mg doxycycline monohydrate tablet (Test) during the second period.
955635|NCT00939562|P1|Participant Flow|Doxycycline Monohydrate, Then Doxycycline Carragenate|Single dose of one 100 mg doxycycline monohydrate tablet (Test) during first period and single dose of one 100 mg doxycycline carragenate tablet (Reference) during the second period.
955636|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
955637|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
955638|NCT00939562|O2|Outcome|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
955639|NCT00939562|O1|Outcome|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
955640|NCT00939562|E2|Reported Event|Doxycycline Carragenate|Single dose of one 100 mg doxycycline carragenate tablet (Reference).
955641|NCT00939562|E1|Reported Event|Doxycycline Monohydrate|Single dose of one 100 mg doxycycline monohydrate tablet (Test).
955642|NCT00939536|B3|Baseline|Total|Total of all reporting groups
955643|NCT00939536|B2|Baseline|Active Comparator|Ambien® 10mg tablets
955644|NCT00939536|B1|Baseline|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955645|NCT00939536|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
955646|NCT00939536|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
955647|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
955648|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955649|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
955650|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955651|NCT00939536|O2|Outcome|Active Comparator|Ambien® 10mg tablets
955652|NCT00939536|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955653|NCT00939536|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
955654|NCT00939536|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955655|NCT00939510|B1|Baseline|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
955656|NCT00939510|P1|Participant Flow|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
955657|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
955658|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
955659|NCT00939510|O1|Outcome|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
955703|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955660|NCT00939510|E1|Reported Event|Lenalidomide (Revlimid) and Sargramostim (GM-CSF)|Sargramostim (GM-CSF) was administered at a dose of 250ug/m2 administered subcutaneously three times weekly every week. No dose escalations or de-escalations of GM-CSF were made. Lenalidomide was administered orally at 25 mg/day on days 1-21 of a 28-day cycle.
955661|NCT00939484|B4|Baseline|Total|Total of all reporting groups
955662|NCT00939484|B3|Baseline|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
955663|NCT00939484|B2|Baseline|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
955664|NCT00939484|B1|Baseline|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
955665|NCT00939484|P3|Participant Flow|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
955666|NCT00939484|P2|Participant Flow|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
955667|NCT00939484|P1|Participant Flow|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
955668|NCT00939484|O1|Outcome|PBTC025B|Adult patients with a histologically confirmed diagnosis of medulloblastoma (including posterior fossa PNET) that is recurrent, progressive, or refractory.
955669|NCT00939484|O1|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
955670|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
955671|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
955672|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
955673|NCT00939484|O3|Outcome|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
955674|NCT00939484|O2|Outcome|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
955675|NCT00939484|O1|Outcome|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
955676|NCT00939484|E3|Reported Event|Stratum C (Unknown PTCH/SHH Pathway Activation)|Adult patients with recurrent or refractory medulloblastoma registered on protocol whose tumor assay is inconclusive as to whether or not the PTCH/SHH pathway is activated or whose tissue sample is inadequate to assess the PTCH/SHH pathway status
955677|NCT00939484|E2|Reported Event|Stratum B (PTCH/SHH Pathway Activated)|Adult patients with recurrent or refractory medulloblastoma who have tumors with evidence of activation of the PTCH/SHH pathway
955678|NCT00939484|E1|Reported Event|Stratum A (PTCH/SHH Pathway Inactivated)|Adult patients with recurrent or refractory medulloblastoma who have tumors without evidence of PTCH/SHH pathway activation
955679|NCT00939471|B1|Baseline|Balloon Device|Balloon catheter dilation of sinus ostia
955680|NCT00939471|P1|Participant Flow|Balloon Device|Balloon catheter dilation of sinus ostia
955681|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955682|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955683|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955684|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955685|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955686|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955687|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955688|NCT00939471|O1|Outcome|Balloon Sinuplasty Treatment|Balloon catheter dilation of sinus ostia
955689|NCT00939471|E1|Reported Event|Balloon Device|Balloon catheter dilation of sinus ostia
955690|NCT00939393|B3|Baseline|Total|Total of all reporting groups
955691|NCT00939393|B2|Baseline|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955692|NCT00939393|B1|Baseline|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955693|NCT00939393|P2|Participant Flow|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955694|NCT00939393|P1|Participant Flow|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955864|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
955865|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955697|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955698|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955699|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955700|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955704|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955705|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955706|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955707|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955708|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955709|NCT00939393|O2|Outcome|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955710|NCT00939393|O1|Outcome|In Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955711|NCT00939393|E2|Reported Event|Operating Room|Endoscopic sinus surgery performed in the operating room (OR) with or without balloon sinus dilation devices.
955712|NCT00939393|E1|Reported Event|Office|Endoscopic sinus surgery performed in physician's office using balloon sinus dilation device.
955713|NCT00939367|B1|Baseline|All Study Participants|Torrent's Zolpidem Tartrate Tablets 10 mg and Ambien® 10mg tablets
955714|NCT00939367|P2|Participant Flow|Ambien First, Then Torrent's Zolpidem|"For period one - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the test formulation, Torrent's Zolpidem 10 mg."
955715|NCT00939367|P1|Participant Flow|Torrent's Zolpidem First, Then Ambien|"For period one - on the morning of Day 1 subjects received Torrent's Zolpidem 10 mg.~Followed by a 7 day washout period.~For period two - on the morning of Day 1 subjects received the reference formulation, Ambien 10 mg."
955716|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
955717|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955718|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
955719|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955720|NCT00939367|O2|Outcome|Active Comparator|Ambien® 10mg tablets
955721|NCT00939367|O1|Outcome|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955722|NCT00939367|E2|Reported Event|Active Comparator|Ambien® 10mg tablets
955723|NCT00939367|E1|Reported Event|Experimental|Torrent's Zolpidem Tartrate Tablets 10 mg
955724|NCT00939341|B1|Baseline|Symbicort Turbuhaler|160/4.5 µg delivered dose
955725|NCT00939341|P1|Participant Flow|Symbicort Turbuhaler|160/4.5 µg delivered dose
955726|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955727|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955728|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955729|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955730|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955731|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955732|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955733|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955734|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955735|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955736|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955737|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955738|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955739|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955740|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955741|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955742|NCT00939341|O1|Outcome|Symbicort Turbuhaler|160/4.5 µg delivered dose
955743|NCT00939341|E1|Reported Event|Symbicort Turbuhaler|160/4.5 µg delivered dose
955744|NCT00939211|B1|Baseline|Overall Number of Baseline Participants|
955745|NCT00939211|P1|Participant Flow|Entire Study Population|
955746|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955747|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955748|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955749|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955750|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955853|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
955751|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955752|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955753|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955754|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955755|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955756|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955757|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955758|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955759|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955760|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955761|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955762|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955763|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955764|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955765|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955766|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955767|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955768|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955769|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955770|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955771|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955772|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955773|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955774|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955775|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955776|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955777|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955778|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955779|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955780|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955781|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955782|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955783|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955784|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955785|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955786|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955787|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955788|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955789|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955790|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955791|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955792|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955793|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955794|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955795|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955796|NCT00939211|O5|Outcome|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955797|NCT00939211|O4|Outcome|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955798|NCT00939211|O3|Outcome|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955799|NCT00939211|O2|Outcome|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955800|NCT00939211|O1|Outcome|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955801|NCT00939211|E5|Reported Event|Placebo for Spiriva First, Then Placebo for AZD9164|1 x placebo Spiriva dry powder for inhalation + 1 x placebo for AZD9164 (sodium chloride)
955802|NCT00939211|E4|Reported Event|Spiriva 18 Mcg First, Then Placebo for AZD9164|1 x Spiriva dry powder for inhalation 18 mcg + 1 x placebo for AZD9164 (sodium chloride)
955803|NCT00939211|E3|Reported Event|AZD9164 1200 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 1200 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955804|NCT00939211|E2|Reported Event|AZD9164 400 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 400 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955805|NCT00939211|E1|Reported Event|AZD9164 100 Mcg First, Then Placebo for Spiriva|1 x AZD9164 solution for inhalation through nebulisation 100 mcg (lung deposited dose) + 1 x placebo for Spiriva dry powder for inhalation
955806|NCT00939185|B1|Baseline|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
955807|NCT00939185|P1|Participant Flow|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
955808|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
955809|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
955810|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
955811|NCT00939185|O1|Outcome|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
955854|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
955855|NCT00939107|E2|Reported Event|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
955812|NCT00939185|E1|Reported Event|Azithromycin|The total dose of 30 mg/kg could have been given as a single daily dose of 10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on Day 1, then 5 mg/kg on Days 2-5. For pediatric streptococcal pharyngitis, azithromycin could have been given as a single dose of 10 mg/kg or 20 mg/kg for 3 days; with a maximum daily dose of 500 mg. For children with acute otitis media, a single dose of 30 mg/kg could have been given.
955813|NCT00939159|B1|Baseline|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
955814|NCT00939159|P1|Participant Flow|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
955815|NCT00939159|O1|Outcome|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
955816|NCT00939159|E1|Reported Event|LBH589|LBH589 20 mg capsules by mouth 3 times a week for 3 weeks in a 28-day cycle.
955818|NCT00939120|B2|Baseline|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955819|NCT00939120|B1|Baseline|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955820|NCT00939120|P2|Participant Flow|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955821|NCT00939120|P1|Participant Flow|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955822|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955823|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955824|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955825|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955826|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955827|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955828|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955829|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955830|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955831|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955832|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955833|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955834|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955835|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955836|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955837|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955838|NCT00939120|O2|Outcome|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955839|NCT00939120|O1|Outcome|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955840|NCT00939120|E2|Reported Event|Placebo + Dutasteride 0.5mg|Patients randomized to control group received Dutasteride 0.5mg orally once daily plus placebo orally once daily.
955841|NCT00939120|E1|Reported Event|Tolterodine ER 4mg + Dutasteride 0.5mg|Patients randomized to experimental group received Dutasteride 0.5mg orally once daily plus Tolterodine ER 4mg orally once daily.
955842|NCT00939107|B3|Baseline|Total|Total of all reporting groups
955843|NCT00939107|B2|Baseline|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
955844|NCT00939107|B1|Baseline|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
955845|NCT00939107|P2|Participant Flow|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
955846|NCT00939107|P1|Participant Flow|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
955847|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
955848|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
955849|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
955850|NCT00939107|O1|Outcome|McKenzie Exercises|McKenzie exercises according to the principles of Mechanical Diagnosis and Therapy
955851|NCT00939107|O2|Outcome|Spinal Manipulation|Spinal manipulation in combination with information of clinical findings and advice about back care
955868|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
955869|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955870|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
955871|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955872|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
955873|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955874|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
955875|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955876|NCT00939094|O2|Outcome|2 - Placebo|Placebo, capsule
955877|NCT00939094|O1|Outcome|A - AZD2066|AZD2066, 12 mg capsule
955878|NCT00939094|E2|Reported Event|2 - Placebo|Placebo, capsule
955879|NCT00939094|E1|Reported Event|A - AZD2066|AZD2066, 12 mg capsule
955880|NCT00939055|B3|Baseline|Total|Total of all reporting groups
955882|NCT00939055|B1|Baseline|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
955883|NCT00939055|P2|Participant Flow|Sham Procedure|"No intervention~Sham procedure: False procedure"
955884|NCT00939055|P1|Participant Flow|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
955885|NCT00939055|O2|Outcome|Sham Procedure|"No intervention~Sham procedure: False procedure"
955886|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
955887|NCT00939055|O2|Outcome|Sham|No intervention
955888|NCT00939055|O1|Outcome|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
955889|NCT00939055|E2|Reported Event|Sham|No intervention
955890|NCT00939055|E1|Reported Event|StomaphyX|"Post-Roux-en-Y revisional surgery using the StomaphyX device.~StomaphyX: Revisional incisionless natural orifice surgery of gastric pouch and stoma.~GI tissue approximation and creation of full-thickness (serosa-to-serosa) plications"
955891|NCT00939029|B3|Baseline|Total|Total of all reporting groups
955892|NCT00939029|B2|Baseline|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
955893|NCT00939029|B1|Baseline|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
955894|NCT00939029|P2|Participant Flow|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
955895|NCT00939029|P1|Participant Flow|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
955896|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
955897|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
955898|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
955899|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
955900|NCT00939029|O2|Outcome|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
955901|NCT00939029|O1|Outcome|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
955902|NCT00939029|E2|Reported Event|Placebo|"2 patches (containing non active ingredients) per day for 8 weeks~placebo NRT: 2 placebo patches (containing no active ingredient)per day for 8 weeks"
955903|NCT00939029|E1|Reported Event|Active|"2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks~nicotine replacement therapy (nicotine patches): 2- 21 mg patches per day for 8 weeks"
955904|NCT00939003|B3|Baseline|Total|Total of all reporting groups
955905|NCT00939003|B2|Baseline|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955906|NCT00939003|B1|Baseline|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955907|NCT00939003|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955908|NCT00939003|P1|Participant Flow|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955909|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955910|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
956037|NCT00938704|E2|Reported Event|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
958699|NCT00930761|P2|Participant Flow|Music Therapy|
955911|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955912|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955913|NCT00939003|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
955914|NCT00939003|O1|Outcome|Placebo|Participants received placebo every other week for 12 weeks during the double-blind period and then received adalimumab 40 mg subcutaneously every other week for up to 144 weeks during the open-label period.
956356|NCT00937833|E2|Reported Event|Control|No sling placed at the time of prostatectomy
955915|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955916|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955917|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955918|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955919|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955920|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955921|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955922|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955923|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955924|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955925|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955926|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955927|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955928|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955929|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955930|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955931|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955932|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955933|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955934|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955935|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955936|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955937|NCT00939003|O2|Outcome|Double-blind Adalimumab|Double-blind adalimumab 40 mg subcutaneously every other week for 12 weeks
955938|NCT00939003|O1|Outcome|Double-blind Placebo|Double-blind placebo every other week for 12 weeks
955939|NCT00939003|E3|Reported Event|Any Adalimumab|Participants who received any dose of adalimumab during the 12-week double-blind period or during the 144-week open-label period.
955940|NCT00939003|E2|Reported Event|Double-blind Adalimumab|Participants received adalimumab 40 mg subcutaneously every other week for 12 weeks during the double-blind period.
955941|NCT00939003|E1|Reported Event|Double-blind Placebo|Participants received placebo every other week for 12 weeks during the double-blind period.
955942|NCT00938886|B3|Baseline|Total|Total of all reporting groups
955943|NCT00938886|B2|Baseline|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
955944|NCT00938886|B1|Baseline|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
955945|NCT00938886|P2|Participant Flow|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
955946|NCT00938886|P1|Participant Flow|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
955947|NCT00938886|O2|Outcome|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
955948|NCT00938886|O1|Outcome|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
955949|NCT00938886|O2|Outcome|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
955950|NCT00938886|O1|Outcome|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
955951|NCT00938886|E2|Reported Event|Placebo|"Daily matched placebo pill~Placebo: Matched naltrexone placebo"
955952|NCT00938886|E1|Reported Event|Naltrexone|"50 mg daily naltrexone for 10 weeks~Naltrexone: Daily 50 mg naltrexone"
955953|NCT00938860|B3|Baseline|Total|Total of all reporting groups
955954|NCT00938860|B2|Baseline|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955955|NCT00938860|B1|Baseline|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955956|NCT00938860|P2|Participant Flow|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
956038|NCT00938704|E1|Reported Event|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956039|NCT00938639|B3|Baseline|Total|Total of all reporting groups
958700|NCT00930761|P1|Participant Flow|Control|
955957|NCT00938860|P1|Participant Flow|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955958|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955959|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
961707|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
955960|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955961|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955962|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955963|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955964|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955965|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955966|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955967|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955968|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955969|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955970|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955971|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955972|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955973|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955974|NCT00938860|O2|Outcome|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955975|NCT00938860|O1|Outcome|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955976|NCT00938860|E2|Reported Event|Neoral|Neoral® (cyclosporine for microemulsion), available as 10 mg, 25 mg, 50 mg and 100 mg soft gelatin capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals, Doses were to be adjusted as necessary to achieve and maintain recommended C0 (monitoring of trough levels) or C2 concentration 2 hours post dosing) target ranges
955977|NCT00938860|E1|Reported Event|Tacrolimus|Prograf® (tacrolimus) provided as 0.5 mg, 1 mg and 5 mg capsules taken on a twice daily (b.i.d) schedule at 12-hour intervals. Doses were adjusted as necessary to achieve and maintain recommended C0 target ranges
955978|NCT00938782|B3|Baseline|Total|Total of all reporting groups
955979|NCT00938782|B2|Baseline|2 - CONTROL Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was not based on SEDLine™ data (CONTROL group)"
956161|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
955980|NCT00938782|B1|Baseline|1 - SEDLine™ Group|"Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.~Surgical patients older than 65 years of age receiving beta-adrenergic blockers for a minimum of 24 hours preoperatively were randomized to two groups: a group whose titration of sevoflurane was based on SEDLine™ data (SEDLine™ group)."
955981|NCT00938782|P2|Participant Flow|2- Control Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on physiologic vitals without input from Sedline monitor.
956044|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
955982|NCT00938782|P1|Participant Flow|1 - SEDLine™ Group|Surgical patient group randomized to active monitoring with Sedline monitor plus other routine monitors. Anesthesia protocol developed with respect to titrate based on vital plus Sedline monitor.
955983|NCT00938782|O2|Outcome|2 - Control Group|Patient groups randomized to active monitoring versus blinded monitoring. This group had teh clinician blinded to output of the Sedline monitor.
955984|NCT00938782|O1|Outcome|1 - Sedline Group|Patient group randomized to active monitoring with Sedline monitor.
955985|NCT00938782|E2|Reported Event|Group 2 - Control Group|Patient groups randomized to monitoring with blinded data not used to titrate anesthesia.
955986|NCT00938782|E1|Reported Event|1 - SEDLine Group|Patient groups randomized to active monitoring. This group had Sedline monitor used to titrate anesthesia.
955987|NCT00938717|B3|Baseline|Total|Total of all reporting groups
955988|NCT00938717|B2|Baseline|Linaclotide|Linaclotide 290μg, oral administration, once per day.
955989|NCT00938717|B1|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
955990|NCT00938717|P2|Participant Flow|Linaclotide|Linaclotide 290μg, oral administration, once per day.
955991|NCT00938717|P1|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
955992|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
955993|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
955994|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
955995|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
955996|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
955997|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
955998|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
955999|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956000|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956001|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956002|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956003|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956004|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956005|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956006|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956007|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956008|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956009|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956010|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956011|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956012|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956013|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956014|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956015|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956016|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956017|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956018|NCT00938717|O2|Outcome|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956019|NCT00938717|O1|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
956020|NCT00938717|E2|Reported Event|Linaclotide|Linaclotide 290μg, oral administration, once per day.
956021|NCT00938717|E1|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
956022|NCT00938704|B3|Baseline|Total|Total of all reporting groups
956023|NCT00938704|B2|Baseline|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
956024|NCT00938704|B1|Baseline|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956025|NCT00938704|P2|Participant Flow|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
956026|NCT00938704|P1|Participant Flow|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956027|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
956028|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956029|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
956030|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956031|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
956032|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956033|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
956034|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956035|NCT00938704|O2|Outcome|Sodium Hyaluronate 0.18%|sodium hyaluronate 0.18%
956036|NCT00938704|O1|Outcome|Carboxymethylcellulose 0.5%, Glycerin 0.9%|carboxymethylcellulose 0.5%, glycerin 0.9%
956040|NCT00938639|B2|Baseline|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956041|NCT00938639|B1|Baseline|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956042|NCT00938639|P2|Participant Flow|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956043|NCT00938639|P1|Participant Flow|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956045|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956046|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956047|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956048|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956049|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956050|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956051|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956052|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956053|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956054|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956055|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956056|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956057|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956058|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956059|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956060|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956061|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956062|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956063|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956064|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956065|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956066|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956067|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956068|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956069|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956070|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956071|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956072|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956073|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956074|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956075|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956076|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956077|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956119|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
956078|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956079|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956080|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956081|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956082|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956083|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956084|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956085|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956086|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956087|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956088|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956089|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956090|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956091|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956092|NCT00938639|O4|Outcome|CSL425 (30 mcg), Older Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956093|NCT00938639|O3|Outcome|CSL425 (30 mcg), Adult|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956094|NCT00938639|O2|Outcome|CSL425 (15 mcg), Older Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956095|NCT00938639|O1|Outcome|CSL425 (15 mcg), Adult|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956096|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956097|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956098|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956099|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956100|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956101|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956102|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956103|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956104|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956105|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956106|NCT00938639|O2|Outcome|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956107|NCT00938639|O1|Outcome|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956108|NCT00938639|E2|Reported Event|CSL425 (30 mcg)|30 mcg of haemagglutinin antigen per dose. 0.5 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956109|NCT00938639|E1|Reported Event|CSL425 (15 mcg)|15 mcg of haemagglutinin antigen per dose. 0.25 mL intramuscular injection into the deltoid region of the arm on Day 0 and Day 21
956110|NCT00938548|B3|Baseline|Total|Total of all reporting groups
956111|NCT00938548|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
956112|NCT00938548|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
956113|NCT00938548|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
956114|NCT00938548|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
956115|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
956116|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
956117|NCT00938548|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
956118|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
956120|NCT00938548|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
956121|NCT00938548|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
956122|NCT00938548|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
956123|NCT00938470|B3|Baseline|Total|Total of all reporting groups
956124|NCT00938470|B2|Baseline|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956168|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
961708|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
956125|NCT00938470|B1|Baseline|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956126|NCT00938470|P2|Participant Flow|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956127|NCT00938470|P1|Participant Flow|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956128|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956129|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956130|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956131|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956132|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956133|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956134|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956135|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956136|NCT00938470|O2|Outcome|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956158|NCT00938431|P2|Participant Flow|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956159|NCT00938431|P1|Participant Flow|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
958701|NCT00930761|O2|Outcome|Music Therapy|
956137|NCT00938470|O1|Outcome|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956138|NCT00938470|E2|Reported Event|Arm II (5FU/O/RT, Surgery)|Patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 of oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) and then surgery.
956139|NCT00938470|E1|Reported Event|Arm I (DOC, 5FU/O/RT, Surgery)|Patients receive 60mg/m^2 docetaxel (D) IV over 1 hour and 85mg/m^2 oxaliplatin (O) IV over 2 hours on day 1. Patients also receive 625 mg/m^2/dose twice a day of capecitabine (C) PO BID on days 1-14. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. After completion of the second course, patients receive 180 mg/m^2 per day of fluorouracil (5FU) IV continuously on days 1-5 and 85 mg/m^2 oxaliplatin (O) IV over 2 hours on days 1, 15, and 29. Patients also undergo radiation therapy (RT) 5 days a week for 5.5 weeks in the absence of disease progression or unacceptable toxicity. Approximately 4-12 weeks after completion of radiation therapy, patients undergo surgery.
956140|NCT00938457|B1|Baseline|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956141|NCT00938457|P1|Participant Flow|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956142|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956143|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956144|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956145|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956146|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956147|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956148|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956149|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956150|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956151|NCT00938457|O1|Outcome|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956152|NCT00938457|E1|Reported Event|Arm I|Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
956153|NCT00938431|B4|Baseline|Total Title|
956154|NCT00938431|B3|Baseline|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956155|NCT00938431|B2|Baseline|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956156|NCT00938431|B1|Baseline|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956157|NCT00938431|P3|Participant Flow|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956160|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
956162|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
956163|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
956164|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
956165|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
956166|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
956167|NCT00938431|O1|Outcome|All Subjects (Safety Set)|All subjects from >=1 month to <=17 years
957086|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
956169|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956170|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956171|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956172|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956173|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956174|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956175|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956176|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Full Analysis Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956177|NCT00938431|O3|Outcome|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956178|NCT00938431|O2|Outcome|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956179|NCT00938431|O1|Outcome|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956180|NCT00938431|E3|Reported Event|>=12 Years to <=17 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956181|NCT00938431|E2|Reported Event|>=4 Years to <12 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956182|NCT00938431|E1|Reported Event|>=1 Month to <4 Years (Safety Set)|Subjects were classified as belonging to the age group based on their age at time of enrollment
956183|NCT00938392|B3|Baseline|Total|Total of all reporting groups
956184|NCT00938392|B2|Baseline|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956185|NCT00938392|B1|Baseline|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956186|NCT00938392|P2|Participant Flow|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956187|NCT00938392|P1|Participant Flow|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956188|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956189|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956190|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956191|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956192|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956193|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956194|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956195|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956196|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956197|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956198|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956199|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956200|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956201|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956202|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956203|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956204|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956205|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956206|NCT00938392|O2|Outcome|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956207|NCT00938392|O1|Outcome|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956208|NCT00938392|E2|Reported Event|FluNG Fresh Group|Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
956209|NCT00938392|E1|Reported Event|FluNG Aged Group|Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
956210|NCT00938366|B3|Baseline|Total|Total of all reporting groups
956211|NCT00938366|B2|Baseline|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
956212|NCT00938366|B1|Baseline|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
956213|NCT00938366|P2|Participant Flow|Cladribine + Pantoprazole Followed by Cladribine|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day. After a wash out period of 10-25 days, subjects received a single 10 mg cladribine dose orally.
956214|NCT00938366|P1|Participant Flow|Cladribine Followed by Cladribine + Pantoprazole|Subjects received a single 10 milligram (mg) cladribine dose orally on Day 1 followed by a wash out period of 10-25 days. Subjects then received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post pantoprazole dose on second day. After administration of cladribine, subjects were required to fast for an additional 2 hours.
956215|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956216|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956217|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956218|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956219|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956220|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956221|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956222|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956223|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956224|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956225|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956226|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956227|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956228|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956229|NCT00938366|O2|Outcome|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956230|NCT00938366|O1|Outcome|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956231|NCT00938366|E2|Reported Event|Cladribine + Pantoprazole|Subjects received pantoprazole 40 mg orally for 2 consecutive days. A single 10 mg cladribine dose was administered orally after 3 hours of fasting post the pantoprazole dose on second day in either first or second intervention period.
956232|NCT00938366|E1|Reported Event|Cladribine|Subjects received two single doses of cladribine 10 mg orally in either first or second intervention period followed by a washout period of 10-25 days.
956233|NCT00938327|B1|Baseline|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
956234|NCT00938327|P1|Participant Flow|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
956235|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
956236|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
956237|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
956275|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956238|NCT00938327|O1|Outcome|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
956239|NCT00938327|E1|Reported Event|Rotarix Group|Subjects who have received 2 oral doses (or a second dose for subjects who had already received the first dose prior to joining the study) of Rotarix™ at an interval of not less than 4 weeks between the doses.
956240|NCT00938314|B5|Baseline|Total|Total of all reporting groups
956241|NCT00938314|B4|Baseline|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
961709|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
956242|NCT00938314|B3|Baseline|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956243|NCT00938314|B2|Baseline|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956244|NCT00938314|B1|Baseline|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956245|NCT00938314|P4|Participant Flow|Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956246|NCT00938314|P3|Participant Flow|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956247|NCT00938314|P2|Participant Flow|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956248|NCT00938314|P1|Participant Flow|NTx®-265 Low Dose|human chorionic gonadotropin (hCG) 385 µg (10,000 international unit [IU]), subcutaneously (SC), on Day 1, 3 and 5 of study participation, then epoetin alfa (EPO) 4,000 IU, intravenously (IV), on Day 7, 8, and 9 of study participation
956249|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956250|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956251|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956252|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956253|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956254|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956255|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956256|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956257|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956258|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956259|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956260|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956261|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956262|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956263|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956264|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956265|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956266|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956267|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956268|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956269|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956270|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956271|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956272|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956273|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956274|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956697|NCT00936715|B1|Baseline|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
956276|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956277|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956278|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956279|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956280|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956281|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956282|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956283|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956284|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956285|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956286|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956287|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956288|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956289|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956290|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956291|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956292|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956293|NCT00938314|O4|Outcome|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956294|NCT00938314|O3|Outcome|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956295|NCT00938314|O2|Outcome|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956296|NCT00938314|O1|Outcome|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956297|NCT00938314|E4|Reported Event|Saline Placebo|saline SC, on Day 1, 3 and 5 of study participation, then saline IV, on Day 7, 8, and 9 of study participation
956298|NCT00938314|E3|Reported Event|NTx®-265 High Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 20,000 IU, IV, on Day 7, 8, and 9 of study participation
956299|NCT00938314|E2|Reported Event|NTx®-265 Medium Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 12,000 IU, IV, on Day 7, 8, and 9 of study participation
956300|NCT00938314|E1|Reported Event|NTx®-265 Low Dose|hCG 385 µg (10,000 IU), SC, on Day 1, 3 and 5 of study participation, then EPO 4,000 IU, IV, on Day 7, 8, and 9 of study participation
956301|NCT00938041|B1|Baseline|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956302|NCT00938041|P1|Participant Flow|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956315|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956316|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956317|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956318|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956319|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956320|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956321|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956322|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956303|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956304|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956305|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956306|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956307|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956308|NCT00938041|O1|Outcome|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956309|NCT00938041|E1|Reported Event|Tositumomab and Antibody Radiolabeled Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets orally starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour, followed by 35 mg of antibody containing 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour, followed by 35 mg of antibody radiolabeled with enough Iodine I-131 TST to deliver 75 centigrey (cGy) infused over 20 min, followed by a 10-min normal saline flush.
956310|NCT00938015|B1|Baseline|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956311|NCT00938015|P1|Participant Flow|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956312|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956313|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956314|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
958702|NCT00930761|O1|Outcome|Control|
956323|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956324|NCT00938015|O1|Outcome|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956325|NCT00938015|E1|Reported Event|Etanercept|Participants with psoriatic arthritis (PsA) who received etanercept (Enbrel) as per standard practice were observed for 6.5 years.
956326|NCT00937950|B1|Baseline|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956327|NCT00937950|P1|Participant Flow|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956328|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956329|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956330|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956331|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956332|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956333|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956334|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956335|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956336|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956337|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956338|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956339|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956340|NCT00937950|O1|Outcome|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956341|NCT00937950|E1|Reported Event|Cervarix Group|Subjects vaccinated with 3 doses of Cervarix in the NCT00122681 study, who displayed normal cervical cytology but tested positive for oncogenic HPV infection or were pregnant, so that no cervical sample could be collected at their last visit.
956342|NCT00937937|B1|Baseline|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
956343|NCT00937937|P1|Participant Flow|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
956344|NCT00937937|O1|Outcome|Dinaciclib|
956345|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
956346|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
956347|NCT00937937|O1|Outcome|Dinaciclib|Patients receive dinaciclib IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
956348|NCT00937937|E1|Reported Event|SCH 727965|
956349|NCT00937833|B3|Baseline|Total|Total of all reporting groups
956350|NCT00937833|B2|Baseline|Control|No sling placed at the time of prostatectomy
956351|NCT00937833|B1|Baseline|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
956352|NCT00937833|P2|Participant Flow|Control|No sling placed at the time of prostatectomy
956353|NCT00937833|P1|Participant Flow|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
956354|NCT00937833|O2|Outcome|Control|No sling placed at the time of prostatectomy
956355|NCT00937833|O1|Outcome|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
956357|NCT00937833|E1|Reported Event|Urethrovesical Sling|Surgisis Male Sling: The SurgiSIS Biodesign, a urethrovescial sling, is placed at the time of prostatectomy.
956358|NCT00937794|B1|Baseline|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
956359|NCT00937794|P1|Participant Flow|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
956360|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
956361|NCT00937794|O1|Outcome|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
956362|NCT00937794|E1|Reported Event|All Patients|All patients who met the inclusion criteria and consented to participate in the study.
956363|NCT00937768|B3|Baseline|Total|Total of all reporting groups
956364|NCT00937768|B2|Baseline|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
956365|NCT00937768|B1|Baseline|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
956366|NCT00937768|P2|Participant Flow|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
956367|NCT00937768|P1|Participant Flow|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
956368|NCT00937768|O2|Outcome|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
956369|NCT00937768|O1|Outcome|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
956370|NCT00937768|E2|Reported Event|No Androgen Deprivation Therapy|Patients undergo observation every 3 months for 9 months.
956371|NCT00937768|E1|Reported Event|Androgen Deprivation Therapy|Patients receive leuprolide acetate intramuscularly (IM) on day 1 OR goserelin acetate subcutaneously (SC) on day 1.
956372|NCT00937560|B1|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
956373|NCT00937560|P1|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
956374|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
956375|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
956376|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone. Only participants with measureable disease were included in the analysis according to RECIST only. Only participants with an ovarian cancer mucin CA-125 level ≥ 2 times the upper limit of normal were included in the analysis according to CA-125 level only.
956377|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
956378|NCT00937560|O1|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.
956379|NCT00937560|E1|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|"Participants received 6-8 (at the investigator’s discretion) 3-week cycles of bevacizumab 7.5 mg/kg intravenously (iv) on Day 1 of each cycle, paclitaxel 80 mg/m^2 iv on Days 1, 8, and 15 of each cycle, and carboplatin iv to an area under the curve of 6 on Day 1 of each cycle. The initial dose of carboplatin was calculated according to the Calvert formula (mg = [glomerular filtration rate + 25] x 6). Following the combination treatments, participants received up to 17 3-week cycles of bevacizumab 7.5 mg/g iv alone.~Bevacizumab: Bevacizumab was supplied as a sterile solution for infusion.~Paclitaxel: Paclitaxel was supplied locally in commercial batches.~Carboplatin: Carboplatin was supplied locally in commercial batches."
956380|NCT00937547|B4|Baseline|Total|Total of all reporting groups
956381|NCT00937547|B3|Baseline|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
956382|NCT00937547|B2|Baseline|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
956383|NCT00937547|B1|Baseline|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
956384|NCT00937547|P3|Participant Flow|Cervical Intraepithelial Neoplasia 3|patients with histological diagnosis of cervical intraepithelial neoplasia grade 3
956385|NCT00937547|P2|Participant Flow|Cervical Intraepithelial Neoplasia 2|patients with histological diagnosis of cervical intraepithelial neoplasia grade 2
956386|NCT00937547|P1|Participant Flow|Invasive Cervical Cancer|patients with histologic diagnosis invasive cervical cancer.
956387|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956388|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956389|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956390|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956391|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956392|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956393|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956394|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956395|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956396|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956397|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956398|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956399|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956400|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956401|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956402|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956403|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956404|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956405|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956406|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956407|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956408|NCT00937547|O3|Outcome|Cervical Intraepithelial Neoplasia 2|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 2
956409|NCT00937547|O2|Outcome|Cervical Intraepithelial Neoplasia 3|Paraffin-embedded sample with histological diagnosis of cervical intraepithelial neoplasia grade 3
956410|NCT00937547|O1|Outcome|Invasive Cervical Cancer|Paraffin-embedded sample with histological diagnosis of invasive cervical cancer
956411|NCT00937547|E3|Reported Event|Intraepithelial Cervical Neoplasia 2|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 2
956412|NCT00937547|E2|Reported Event|Intraepithelial Cervical Neoplasia 3|Paraffin-embedded samples with histological diagnosis of cervical intraepithelial neoplasia grade 3
956413|NCT00937547|E1|Reported Event|Invasive Cervical Cancer|Paraffin-embedded samples with histological diagnosis of invasive cervical cancer
956414|NCT00937521|B9|Baseline|Total|Total of all reporting groups
956415|NCT00937521|B8|Baseline|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956416|NCT00937521|B7|Baseline|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956417|NCT00937521|B6|Baseline|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956418|NCT00937521|B5|Baseline|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956419|NCT00937521|B4|Baseline|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956420|NCT00937521|B3|Baseline|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
957183|NCT00935064|P1|Participant Flow|Aliskiren|300 mg, once daily, for 6 weeks
956421|NCT00937521|B2|Baseline|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956422|NCT00937521|B1|Baseline|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956423|NCT00937521|P8|Participant Flow|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956424|NCT00937521|P7|Participant Flow|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956425|NCT00937521|P6|Participant Flow|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956426|NCT00937521|P5|Participant Flow|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956427|NCT00937521|P4|Participant Flow|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956428|NCT00937521|P3|Participant Flow|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956429|NCT00937521|P2|Participant Flow|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956430|NCT00937521|P1|Participant Flow|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956431|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956432|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956433|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956434|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956435|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956436|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956437|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956438|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956439|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956440|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956441|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956442|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956443|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956444|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956445|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956446|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956447|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956448|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956449|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956450|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956451|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956452|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956453|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956454|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956455|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956456|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956457|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956458|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956459|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956460|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956461|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956462|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956463|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956464|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956465|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956466|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956467|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956468|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956469|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956470|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956471|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956472|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956473|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956474|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
956649|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956475|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal multi-component recombinant, adsorbed vaccine (formulation V)and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956476|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956477|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956478|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956479|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
956480|NCT00937521|O1|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956481|NCT00937521|O2|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956482|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956483|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956484|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956485|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956486|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956487|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956488|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956489|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956490|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956491|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956492|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956493|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956494|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956495|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
956496|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956497|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956498|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age..
956499|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956500|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956501|NCT00937521|O2|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956700|NCT00936715|E1|Reported Event|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered orally once daily for up to 240 weeks
956502|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956503|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956504|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956505|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956506|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956507|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956508|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956509|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956510|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956511|NCT00937521|O8|Outcome|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenCCRM197 at 13 months of age.
956512|NCT00937521|O7|Outcome|MenC (Group VII)|Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age, one dose of meningococcal B recombinant (rMenB+OMV NZ) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age, one dose of rMenB+OMV NZ and one dose of MenC at 13 months of age.
956513|NCT00937521|O6|Outcome|PH2 B+OMV (Group VI)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956514|NCT00937521|O5|Outcome|½ (B+OMV) (Group V)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956515|NCT00937521|O4|Outcome|B (Group IV)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956516|NCT00937521|O3|Outcome|B+1/4 OMV (Group III)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956517|NCT00937521|O2|Outcome|B+½ OMV (Group II)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956518|NCT00937521|O1|Outcome|B+OMV (Group I)|Subjects in this group received one dose of meningococcal B recombinant adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956519|NCT00937521|E16|Reported Event|Par+B+OMV (Group VIII) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to include Booster Phase.
956520|NCT00937521|E15|Reported Event|MenC (Group VII) Booster Phase|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to include Booster Phase."
956521|NCT00937521|E14|Reported Event|PH2 B+OMV (Group VI) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
956522|NCT00937521|E13|Reported Event|½ (B+OMV) (Group V) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
956523|NCT00937521|E12|Reported Event|B (Group IV) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
956524|NCT00937521|E11|Reported Event|B+1/4 OMV (Group III) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
956525|NCT00937521|E10|Reported Event|B+½ OMV (Group II) Booster Phase|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine(formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to include Booster Phase."
956694|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
956526|NCT00937521|E9|Reported Event|B+OMV (Group I) Booster Phase|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.
956551|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956527|NCT00937521|E8|Reported Event|Par+B+OMV (Group VIII)|Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) with paracetamol and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age. Group defined to be applicable Prior to Booster Phase for AEs reporting.
956528|NCT00937521|E7|Reported Event|MenC (Group VII)|"Subjects received one dose of meningococcal C conjugate vaccine (Menjugate®; Men C) and routine vaccine at 2,3,4 months of age and one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VII) and routine vaccine at 12 months of age. One dose of MenC at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
956529|NCT00937521|E6|Reported Event|PH2 B+OMV (Group VI)|"SubjSubjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation VI) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
956530|NCT00937521|E5|Reported Event|½ (B+OMV) (Group V)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation V) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
956531|NCT00937521|E4|Reported Event|B (Group IV)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation IV) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting.."
956532|NCT00937521|E3|Reported Event|B+1/4 OMV (Group III)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation III) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
956533|NCT00937521|E2|Reported Event|B+½ OMV (Group II)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation II) and routine vaccine at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
956534|NCT00937521|E1|Reported Event|B+OMV (Group I)|"Subjects in this group received one dose of meningococcal B recombinant (rMenB) adsorbed vaccine (formulation I) and routine vaccines at 2,3,4,12 months of age and MenC-CRM197 at 13 months of age.~Group defined to be applicable Prior to Booster Phase for AEs reporting."
956535|NCT00937495|B1|Baseline|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
956536|NCT00937495|P1|Participant Flow|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
956537|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
956538|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
956539|NCT00937495|O1|Outcome|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
956540|NCT00937495|E1|Reported Event|Treatment (Vorinostat, Bortezomib)|Patients receive 400 mg vorinostat orally once daily on days 1-14. Patients also receive 1.3 mg/m^2 bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
956541|NCT00937391|B3|Baseline|Total|Total of all reporting groups
956542|NCT00937391|B2|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) – Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956543|NCT00937391|B1|Baseline|Gadopentetate Dimeglumine (Magnevist, BAY86-6661) - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956544|NCT00937391|P1|Participant Flow|Gadopentetate Dimeglumine (Magnevist, BAY86-6661)|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Another group of participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956545|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956546|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956547|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956548|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956549|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956550|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956552|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956553|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956554|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956555|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956556|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956557|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956558|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956559|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956560|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956561|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956562|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956563|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956564|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956565|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956566|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956567|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956568|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956569|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956570|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956571|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956572|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956573|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956574|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956575|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956576|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 2 (Comb. Image)|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956577|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 2 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956578|NCT00937391|O3|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956579|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956580|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Unenh. Image)|Unenhanced image was taken before given any injection to Participants.
956695|NCT00936741|O1|Outcome|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
956599|NCT00937118|P1|Participant Flow|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
956765|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956581|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956582|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956583|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956584|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956585|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956586|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 and 2|For Stage 1: Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW). For Stage 2: Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956587|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956588|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956589|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956590|NCT00937391|O2|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.1 mmol/kg)|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine. Participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956591|NCT00937391|O1|Outcome|Gadopentetate Dimeglumine - Stage 1 (Comb. Image 0.05 mmol/kg)|Participants (n=3) received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Gadopentetate dimeglumine.
956592|NCT00937391|E2|Reported Event|Gadopentetate Dimeglumine - Stage 2|Participants received the optimal efficacious dose established in Stage 1 as a single IV injection of Magnevist Injection (0.1 mmol/kg BW (0.2 mL/kg BW)).
956593|NCT00937391|E1|Reported Event|Gadopentetate Dimeglumine - Stage 1|Participants received an IV injection of 0.05 mmol/kg Body Weight (BW) (0.1 mL/kg BW) Magnevist. Upon completion of the MR imaging, the participants received another injection of 0.05 mmol/kg for a total cumulative dose of 0.1 mmol/kg BW (0.2 mL/kg BW).
956594|NCT00937157|B1|Baseline|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
956595|NCT00937157|P1|Participant Flow|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
956596|NCT00937157|O1|Outcome|Patients Diagnosed With Multiple Sclerosis Who Have the Presen|Copaxone: 12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
956597|NCT00937157|E1|Reported Event|RRMS Patients With >=1 GdE Lesion or Acute Relapse|"Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.~Copaxone: 12 MS patients were enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment was given on day 0. 1.5T and 3T scans were obtained according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids were also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days."
956598|NCT00937118|B1|Baseline|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
956600|NCT00937118|O4|Outcome|Fascial Closure|Patients with full thickness duodenal laceration undergoing laparotomy who did not have damage control and instead had primary fascial closure
956601|NCT00937118|O3|Outcome|Damage Control|Patients with full thickness duodenal laceration undergoing laparotomy who had a damage control technique
956602|NCT00937118|O2|Outcome|Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did have diversion, decompression, or exclusion techniques
956603|NCT00937118|O1|Outcome|No Diversion Decompression or Exclusion|Patients with full thickness duodenal laceration undergoing laparotomy who did not have diversion, decompression, or exclusion techniques
956604|NCT00937118|E1|Reported Event|Injury Management|Patients with full thickness duodenal laceration undergoing laparotomy and surviving more then 72 hours at our level 1 trauma center in the years 1989-2009. Patients requiring pancreaticoduodenectomy were excluded.
956605|NCT00937105|B3|Baseline|Total|Total of all reporting groups
956606|NCT00937105|B2|Baseline|Lotrafilcon A and Clear Care|
956607|NCT00937105|B1|Baseline|Lotrafilcon A and Renu|
956608|NCT00937105|P2|Participant Flow|Lotrafilcon A Lenses and Renu Multiplus|
956609|NCT00937105|P1|Participant Flow|Lotrafilcon A Lenses and Clear Care|
956610|NCT00937105|O2|Outcome|Participants With no CNS Bioburden on Lid Margins|
956611|NCT00937105|O1|Outcome|Participants With CNS Bioburden on Lid Margins|
956612|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lid Margins|
956613|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lid Margins|
956614|NCT00937105|O2|Outcome|Participants With no Microbial Bioburden on Lens Cases|
956615|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lens Cases|
956616|NCT00937105|O2|Outcome|Participants Without Corneal Staining|
956617|NCT00937105|O1|Outcome|Participants With Corneal Staining|
956618|NCT00937105|O2|Outcome|Participants Without Microbial Bioburden on Lenses|
956619|NCT00937105|O1|Outcome|Participants With Microbial Bioburden on Lenses|
956620|NCT00937105|O2|Outcome|Lotrafilcon A Lenses and Clear Care|
956621|NCT00937105|O1|Outcome|Lotrafilcon A Lenses and Renu|
956622|NCT00937105|E1|Reported Event|Entire Cohort of Lotrafilcon A Users|
956623|NCT00937040|B3|Baseline|Total|Total of all reporting groups
956624|NCT00937040|B2|Baseline|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956625|NCT00937040|B1|Baseline|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956626|NCT00937040|P2|Participant Flow|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956627|NCT00937040|P1|Participant Flow|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956628|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956629|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956630|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956631|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956632|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956633|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956634|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956635|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956636|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956637|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956638|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956639|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956640|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956641|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956642|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956643|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956644|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956645|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956646|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956647|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956696|NCT00936741|E1|Reported Event|Mifepristone 300 to 1200 mg Daily|mifepristone at doses from 300 mg/day to 1200 mg/day
956648|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
957184|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
956650|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956651|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956652|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956653|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956654|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956655|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956656|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956657|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956658|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956659|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956660|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956661|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956662|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956663|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956664|NCT00937040|O2|Outcome|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956665|NCT00937040|O1|Outcome|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956666|NCT00937040|E2|Reported Event|OROS MPH|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of Osmotic Release Oral System (OROS) Extended Release Methylphenidate HCl (MPH) - CONCERTA
956667|NCT00937040|E1|Reported Event|PLACEBO|Once daily (morning) tablet(s) taken orally of 18, 36 , 54, or 72 mg of placebo
956668|NCT00936975|B1|Baseline|Overall|Participants receiving 100mg PO QD Dasatinib with F18 Sodium Fluoride PET scans at baseline
956669|NCT00936975|P1|Participant Flow|Overall|Participants on the parent study (“Genomic Guided Therapy with Dasatinib or Nilutamide in Metastatic Castration-Resistant Prostate Cancer”) receiving 100mg PO QD Dasatinib
956670|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
956671|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
956672|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
956673|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
956674|NCT00936975|O1|Outcome|Overall|Participants receiving 100mg PO QD Dasatinib
956675|NCT00936975|O1|Outcome|18F-Fluoride PET|"Patients undergo fluorine F 18 sodium fluoride PET scan at baseline and then at 12 weeks after initiation of treatment with dasatinib. Scans are done of normal bone and tumor bone at each time point~fluorine F 18 sodium fluoride: Undergo fluorine F 18 sodium fluoride PET scan"
956676|NCT00936975|E1|Reported Event|Overall|Participants receiving 100mg PO QD Dasatinib
956677|NCT00936897|B3|Baseline|Total|Total of all reporting groups
956678|NCT00936897|B2|Baseline|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
956679|NCT00936897|B1|Baseline|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
956680|NCT00936897|P2|Participant Flow|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
956681|NCT00936897|P1|Participant Flow|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
956682|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
956683|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
956684|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
956685|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
956686|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
956687|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
956688|NCT00936897|O2|Outcome|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
956689|NCT00936897|O1|Outcome|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
956690|NCT00936897|E2|Reported Event|Denosumab 60 mg SC Q6M|Denosumab 60 mg subcutaneous once every 6 months
956691|NCT00936897|E1|Reported Event|Ibandronate 150 mg PO QM|Ibandronate 150 mg oral monthly
956692|NCT00936741|B1|Baseline|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
956693|NCT00936741|P1|Participant Flow|Open-label|mifepristone at doses from 300 mg/day up to 1200 mg/day daily
956698|NCT00936715|P1|Participant Flow|FTC/TDF|Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, Truvada®) (200/300 mg) fixed dose combination (FDC) tablet administered once daily for up to 240 weeks.
956699|NCT00936715|O1|Outcome|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered once daily for up to 240 weeks
956701|NCT00936702|B1|Baseline|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956702|NCT00936702|P1|Participant Flow|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956703|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956704|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956705|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956706|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956707|NCT00936702|O1|Outcome|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956708|NCT00936702|E1|Reported Event|Treatment (Carboplatin, Paclitaxel, and Everolimus)|Patients receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Patients also receive everolimus PO QD on days 1, 8, and 15.
956709|NCT00936598|B3|Baseline|Total|Total of all reporting groups
956710|NCT00936598|B2|Baseline|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956711|NCT00936598|B1|Baseline|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956712|NCT00936598|P2|Participant Flow|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956713|NCT00936598|P1|Participant Flow|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956714|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956715|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956716|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956717|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956718|NCT00936598|O2|Outcome|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956719|NCT00936598|O1|Outcome|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956720|NCT00936598|E2|Reported Event|Sugar Pill|Participants in the Control group will receive placebo. For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956762|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956721|NCT00936598|E1|Reported Event|Zolpidem|Participants randomized to the Intervention group will receive the FDA approved dose of zolpidem, (10 mg for women <65; 5 mg for women > or = 65 years). For the purposes of this double-blind trial, zolpidem (e.g., Roxane Laboratories) and placebo (sugar) pills will be placed without filler inside two-piece gelatin capsules (DBcaps, Capsugel) and packaged by the Investigational Drug Service (IDS) of the University of Pittsburgh Cancer Institute.
956722|NCT00936585|B1|Baseline|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
956723|NCT00936585|P1|Participant Flow|Immunologic Monitoring|All patients who were enrolled in the main study participated in the NIH sub study and underwent a colonoscopy and blood draw for research specimens for immunologic monitoring before and after study drug administration
956724|NCT00936585|O1|Outcome|Immunologic Monitoring|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
956725|NCT00936585|E1|Reported Event|Colonoscopy|Patients who received both placebo and drug infusions underwent a colonoscopy and blood draw for research specimens for immunological monitoring.
956726|NCT00936481|B3|Baseline|Total|Total of all reporting groups
956727|NCT00936481|B2|Baseline|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
956728|NCT00936481|B1|Baseline|Healthy Controls|18 years or older with body mass index between 25-45
956729|NCT00936481|P2|Participant Flow|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
956730|NCT00936481|P1|Participant Flow|Healthy Controls|18 years or older with body mass index between 25-45
956731|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
956732|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
956733|NCT00936481|O2|Outcome|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
956734|NCT00936481|O1|Outcome|Healthy Controls|18 years or older with body mass index between 25-45
956735|NCT00936481|E2|Reported Event|Obstructive Sleep Apnea Group|Age 18 years or older with body mass index between 25 and 45
956736|NCT00936481|E1|Reported Event|Healthy Controls|18 years or older with body mass index between 25-45
956737|NCT00936455|B3|Baseline|Total|Total of all reporting groups
956738|NCT00936455|B2|Baseline|Telephone|Telephone evaluated patients
956739|NCT00936455|B1|Baseline|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
956740|NCT00936455|P2|Participant Flow|Telephone|Telephone evaluated patients
956741|NCT00936455|P1|Participant Flow|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
956742|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 12 months after index event in telephone group
956743|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 12 months after index event in telemedicine group
956744|NCT00936455|O2|Outcome|Telephone|Assessing number of recurrent strokes by 12 months
956745|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 12 months (patients that retrospectively reporting having had a stroke from 6-12 months after their index event)
956746|NCT00936455|O2|Outcome|Telephone|Recurrent stroke at 6 months in each group
956747|NCT00936455|O1|Outcome|Telemedicine|Assessing amount of patients that had recurrent stroke by 6 months (patients that retrospectively reporting having had a stroke from 0-6 months after their index event)
956748|NCT00936455|O2|Outcome|Telephone|Functional Outcome (mRS(0-1)) at 6 months after index event in the telephone group
956749|NCT00936455|O1|Outcome|Telemedicine|Functional Outcome (mRS(0-1)) at 6 months after index event in the telemedicine group
956750|NCT00936455|E2|Reported Event|Telephone|Telephone evaluated patients
956751|NCT00936455|E1|Reported Event|Telemedicine|Telemedicine evaluated patients- The definition of telemedicine for this trial was the use of 2 way video and 2 way audio videoconferencing and also the use of digital access to radiology image review. Telephone use is not considered telemedicine for the purposes of this trial.
956752|NCT00936377|B4|Baseline|Total|Total of all reporting groups
956753|NCT00936377|B3|Baseline|Placebo|"Normal saline~Placebo: Normal saline for five days."
956754|NCT00936377|B2|Baseline|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956755|NCT00936377|B1|Baseline|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956756|NCT00936377|P3|Participant Flow|Placebo|"Normal saline~Placebo: Normal saline for five days."
956757|NCT00936377|P2|Participant Flow|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956758|NCT00936377|P1|Participant Flow|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956759|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956760|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956761|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956763|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956764|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956766|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956767|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956768|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956769|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956770|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956771|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956772|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956773|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956774|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956775|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956776|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956777|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956778|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956779|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956780|NCT00936377|O3|Outcome|Placebo|"Normal saline~Placebo: Normal saline for five days."
956781|NCT00936377|O2|Outcome|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956782|NCT00936377|O1|Outcome|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956783|NCT00936377|E3|Reported Event|Placebo|"Normal saline~Placebo: Normal saline for five days."
956784|NCT00936377|E2|Reported Event|Dexmedetomidine, High Dose|"Dexmedetomidine 1.2 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956785|NCT00936377|E1|Reported Event|Dexmedetomidine, Low Dose|"Dexmedetomidine 0.4 µg/kg per hour administered for a maximum duration of five days~Dexmedetomidine: Dexmedetomidine at 0.4 or 1.2 µg/kg per hour is administered for a maximum duration of five days"
956786|NCT00936351|B3|Baseline|Total|Total of all reporting groups
956787|NCT00936351|B2|Baseline|Arm 2|"Support Group~Support Group (control): A support group during which participants can discuss with each other any issues, problems, or successes at work will be conducted as the control portion."
956788|NCT00936351|B1|Baseline|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention has been adapted from mindfulness based stress reduction treatment."
956789|NCT00936351|P2|Participant Flow|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
956790|NCT00936351|P1|Participant Flow|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
956791|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
956792|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
956793|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
956844|NCT00936065|P3|Participant Flow|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956845|NCT00936065|P2|Participant Flow|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
957185|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
956794|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
956795|NCT00936351|O2|Outcome|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
956796|NCT00936351|O1|Outcome|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
956797|NCT00936351|E2|Reported Event|Arm 2|"Support Group~The support group leader offered empathic statements, support and led discussion of work related issues and concerns, facilitating members to support and help one another with problem-solving."
956798|NCT00936351|E1|Reported Event|Arm 1|"Mindfulness Meditation~Mindfulness involves teaching individuals skills that improve their ability to attend to their experience in the present moment while suspending judgment and to purposefully shift their attention. Thus mindfulness enhances the ability to monitor and manage emotions and thought processes so that individuals can reflect on, choose, and implement more effective responses. This intervention was adapted from Mindfulness-Based Stress Reduction, an 8-week program developed by Jon Kabat-Zinn."
956799|NCT00936221|B3|Baseline|Total|Total of all reporting groups
956800|NCT00936221|B2|Baseline|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
956801|NCT00936221|B1|Baseline|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
956802|NCT00936221|P2|Participant Flow|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
956803|NCT00936221|P1|Participant Flow|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
956804|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
956805|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
956806|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
956807|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
956808|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
956809|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
956810|NCT00936221|O2|Outcome|Placebo + Dacarbazine|Matched Placebo + dacarbazine
956811|NCT00936221|O1|Outcome|Selumetinib 75mg BD + Dacarbazine|selumetinib 75mg twice daily + dacarbazine
956812|NCT00936221|E2|Reported Event|Placebo BD + Dacarbazine|Placebo twice daily + Dacarbazine
956813|NCT00936221|E1|Reported Event|Selumetinib 75mg BD +Dacarbazine|selumetinib 75mg twice daily + Dacarbazine
956814|NCT00936208|B3|Baseline|Total|Total of all reporting groups
956815|NCT00936208|B2|Baseline|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956816|NCT00936208|B1|Baseline|Micardis 80mg|One tablet of Micardis 80mg per day
956817|NCT00936208|P2|Participant Flow|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956818|NCT00936208|P1|Participant Flow|Micardis 80mg|One tablet of Micardis 80mg per day
956819|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956820|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
956821|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956822|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
956823|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956824|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
956825|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956826|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
956827|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956828|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
956829|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956830|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
956831|NCT00936208|O2|Outcome|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956832|NCT00936208|O1|Outcome|Micardis 80mg|One tablet of Micardis 80mg per day
956833|NCT00936208|E2|Reported Event|Micardis Plus 80mg / 12.5mg|One tablet of Micardis Plus 80 / 12.5mg per day
956834|NCT00936208|E1|Reported Event|Micardis 80mg|One tablet of Micardis 80mg per day
956835|NCT00936117|B1|Baseline|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
956836|NCT00936117|P1|Participant Flow|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
956837|NCT00936117|O2|Outcome|Posaconazole (Males)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
956838|NCT00936117|O1|Outcome|Posaconazole (Females)|Posaconazole 200 mg (liquid) by mouth 3 times per day.
956839|NCT00936117|E1|Reported Event|Posaconazole|Posaconazole 200 mg (liquid) by mouth 3 times per day.
956840|NCT00936065|B4|Baseline|Total|Total of all reporting groups
956841|NCT00936065|B3|Baseline|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956842|NCT00936065|B2|Baseline|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
957074|NCT00935532|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
956843|NCT00936065|B1|Baseline|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
957186|NCT00935064|O2|Outcome|Placebo|Once daily, for 6 weeks
956846|NCT00936065|P1|Participant Flow|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956847|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956848|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956849|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956850|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956851|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956852|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956853|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956854|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956855|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956856|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956857|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956858|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956859|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956860|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956861|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956862|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956863|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956864|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956865|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956866|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956867|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956868|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956869|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956870|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956871|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956872|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956873|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956874|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956875|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956876|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956877|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956878|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956879|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956880|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956881|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956882|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956883|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956884|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956885|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956886|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956887|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956888|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956889|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956890|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956891|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956892|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956893|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956894|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956895|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956896|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956897|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956898|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956899|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956900|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956901|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956902|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956903|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956904|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956905|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956906|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956907|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956908|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956909|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956910|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956911|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956912|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956913|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956914|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956915|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956916|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956917|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956918|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956919|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956920|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956921|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956922|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956923|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956924|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956925|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956926|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956927|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956928|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956929|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956930|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956931|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956932|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956933|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956934|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956935|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956936|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956937|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956938|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956939|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956940|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956941|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956942|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956943|NCT00936065|O3|Outcome|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956944|NCT00936065|O2|Outcome|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956945|NCT00936065|O1|Outcome|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956946|NCT00936065|E3|Reported Event|Acitretin|Acitretin 10 mg subcutaneous injection BID for 24 weeks
956947|NCT00936065|E2|Reported Event|Etanercept and Acitretin|Etanercept 25 mg subcutaneous injection BIW and acitretin 10 mg twice per day (BID) for 24 weeks.
956948|NCT00936065|E1|Reported Event|Etanercept|Etanercept 50 milligram (mg) subcutaneous injection twice weekly (BIW) for 12 weeks followed by Etanercept 25 mg BIW for 12 weeks
956949|NCT00934921|B3|Baseline|Total|Total of all reporting groups
956950|NCT00934921|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
956951|NCT00934921|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
956952|NCT00934921|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in second period
956953|NCT00934921|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
956954|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
956955|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
956956|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
956957|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
956958|NCT00934921|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
956959|NCT00934921|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg Orally Disintegrating Tablet (test) dosed in either period
956960|NCT00935883|B3|Baseline|Total|Total of all reporting groups
956961|NCT00935883|B2|Baseline|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956962|NCT00935883|B1|Baseline|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956963|NCT00935883|P2|Participant Flow|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956964|NCT00935883|P1|Participant Flow|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956965|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956966|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
957075|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957076|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
956990|NCT00935818|B1|Baseline|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
956967|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956968|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956969|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956970|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956971|NCT00935883|O2|Outcome|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956972|NCT00935883|O1|Outcome|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956973|NCT00935883|E2|Reported Event|Eculizumab|"Randomized patients in the drusen or the GA cohort will receive active treatment with eculizumab~Eculizumab: Induction Period: patient will receive eculizumab 600 mg or 900 mg via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by 900 mg or 1200 mg eculizumab for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive eculizumab 900 mg or 1200 mg via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956974|NCT00935883|E1|Reported Event|Saline|"Randomized patients in the drusen or the GA cohort will receive placebo saline infusions as a comparator~Saline: Induction Period: patient will receive saline via IV infusion over approximately 30 minutes once a week (7 ± 2 days) for 4 weeks followed by saline for the fifth dose 7 days later (7 ± 2 days).~Maintenance Period: patient will receive saline via IV infusion over approximately 30 minutes every 2 weeks (14 ± 2 days) until week 24.~Observation period: patient will then be observed for 6 months off treatment with follow-up visits scheduled for 9 months and 12 months."
956975|NCT00935857|B3|Baseline|Total|Total of all reporting groups
956976|NCT00935857|B2|Baseline|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
956977|NCT00935857|B1|Baseline|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
956978|NCT00935857|P2|Participant Flow|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
956979|NCT00935857|P1|Participant Flow|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
956980|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
956981|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
956982|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
956983|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
956984|NCT00935857|O2|Outcome|Standard Colonoscopy|Colonoscopy using a standard adult colonoscope
956985|NCT00935857|O1|Outcome|Balloon Colonoscopy|Colonoscopy using the single balloon enteroscope system.
956986|NCT00935857|E2|Reported Event|Single Balloon Colonoscopy|Patients who are randomized to received single balloon colonoscopy as initial treatment.
956987|NCT00935857|E1|Reported Event|Standard Colonoscopy|Patients who are randomized to received standard colonoscopy as initial treatment.
956988|NCT00935818|B3|Baseline|Total|Total of all reporting groups
956989|NCT00935818|B2|Baseline|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
957077|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957078|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
956991|NCT00935818|P2|Participant Flow|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
956992|NCT00935818|P1|Participant Flow|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
956993|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
956994|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
956995|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
956996|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
956997|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
956998|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
956999|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
957000|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
957001|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
957002|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
957003|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
957004|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
957005|NCT00935818|O2|Outcome|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
957079|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957080|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957006|NCT00935818|O1|Outcome|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
957007|NCT00935818|E2|Reported Event|Varenicline and Placebo|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and placebo (0 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and placebo: varenicline (1 mg bid) for 12 weeks placebo for 12 weeks"
957008|NCT00935818|E1|Reported Event|Varenicline and Buproprion SR|"Everyone randomized to this arm will receive varenicline (up to 1mg bid) and bupropion SR (150 mg bid)for 12 weeks. They will be followed up by study for an additional 9 months post end of medication - for a total of 1 year study participation. Everyone will receive behavioral counseling for the full year.~varenicline and bupropion: varenicline - 1 mg bid for 12 weeks bupropion sr - 150 mg bid for 12 weeks"
957009|NCT00935792|B4|Baseline|Total|Total of all reporting groups
957010|NCT00935792|B3|Baseline|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957011|NCT00935792|B2|Baseline|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957012|NCT00935792|B1|Baseline|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957013|NCT00935792|P3|Participant Flow|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957014|NCT00935792|P2|Participant Flow|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957015|NCT00935792|P1|Participant Flow|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957016|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957017|NCT00935792|O1|Outcome|All Evaluable Patients|Patients are only evaluable for duration of response when they have already been noted as a complete response or partial response.
957018|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957019|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957020|NCT00935792|O1|Outcome|All Evaluable Patients|Patients receive oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957021|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957022|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957023|NCT00935792|O3|Outcome|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957024|NCT00935792|O2|Outcome|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957025|NCT00935792|O1|Outcome|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957026|NCT00935792|E3|Reported Event|Phase 2, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957027|NCT00935792|E2|Reported Event|Phase 1, Dose Level 2|Patients receive 5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957028|NCT00935792|E1|Reported Event|Phase 1, Dose Level 1|Patients receive 2.5mg of oral everolimus thrice weekly for 9 weeks and alemtuzumab subcutaneously thrice weekly for 8 weeks.
957029|NCT00935766|B3|Baseline|Total|Total of all reporting groups
957030|NCT00935766|B2|Baseline|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
957031|NCT00935766|B1|Baseline|Placebo|Placebo (Four 1-gram capsules daily)
957032|NCT00935766|P2|Participant Flow|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
957033|NCT00935766|P1|Participant Flow|Placebo|Placebo (Four 1-gram capsules daily)
957034|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
957035|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
957036|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
957037|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
957038|NCT00935766|O2|Outcome|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
957039|NCT00935766|O1|Outcome|Placebo|Placebo (Four 1-gram capsules daily)
957040|NCT00935766|E2|Reported Event|Omega 3|omega-3-acid ethyl esters (Four 1-gram capsules daily)
957041|NCT00935766|E1|Reported Event|Placebo|Placebo (Four 1-gram capsules daily)
957042|NCT00935701|B1|Baseline|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
957081|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957082|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957083|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957084|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957085|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957043|NCT00935701|P1|Participant Flow|Acupuncture and Acupressure|In Phase 1, 10 children with ASD will receive acupressure for four weeks. At week 5, they will be introduced to acupuncture which will be continued throughout the rest of the study as tolerated. In Phase 2, 40 children with ASD will receive acupressure twice weekly for 12 weeks. Parents will be trained in the acupressure techniques and will be asked to do this daily, at bedtime, and/or as requested by the child or deemed needed by the parent. Children will begin to be assessed for their ability to participate in acupuncture treatment between weeks 5 and 7 at the discretion of the acupuncturist. By week 7, all children will have been introduced to acupuncture/needling. If needling is still refused at this time, acupressure will continue for the remainder of the study.
957044|NCT00935701|O1|Outcome|Primary Group|
957045|NCT00935701|O1|Outcome|Primary Group|
957046|NCT00935701|O1|Outcome|Primary Group|
957047|NCT00935701|O1|Outcome|Primary Group|Phase 1
957048|NCT00935701|E1|Reported Event|Primary Group|
957049|NCT00935649|B1|Baseline|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
957050|NCT00935649|P1|Participant Flow|Randomized Great Toe|Subjects with both great toes infected. Right/left randomized to treatment / no treatment
957051|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
957052|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
957053|NCT00935649|O2|Outcome|Untreated Great Toe|untreated control great toe
957054|NCT00935649|O1|Outcome|Treated Great Toe|Laser treatment of great toe
957055|NCT00935649|E2|Reported Event|Untreated Great Toe|untreated control great toe
957056|NCT00935649|E1|Reported Event|Treated Great Toe|Laser treatment of great toe
957057|NCT00935584|B3|Baseline|Total|Total of all reporting groups
957058|NCT00935584|B2|Baseline|PACE Study Providers|23 providers participated in the study. However, final analysis was based on 126 clinic visits.
957059|NCT00935584|B1|Baseline|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957060|NCT00935584|P2|Participant Flow|PACE Study Providers|23 primary care providers started and 19 completed the study. 22 primary care providers participated in the educational workshop.
957061|NCT00935584|P1|Participant Flow|PACE Study Patients|"The proposed study will use a quasi-experimental (pre-post intervention design). Pre-intervention phase consisted of baseline data collection on EMR usage and patient-physician communication.~126 patients started the study and 77 completed the study."
957062|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957063|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957064|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957065|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957066|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957067|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957068|NCT00935584|O1|Outcome|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957069|NCT00935584|E1|Reported Event|PACE Study|"The proposed study will use a quasi-experimental (pre-post intervention design) carried out in three phases.~Physician training in patient-centered emr use: physician training in patient-centered EMR use (PACE) will be developed. The conceptual model of patient-centered communication will provide the underlying framework for the training aimed at improving physicians interviewing and communication skills."
957070|NCT00935532|B3|Baseline|Total|Total of all reporting groups
957071|NCT00935532|B2|Baseline|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957072|NCT00935532|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957073|NCT00935532|P2|Participant Flow|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957176|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957087|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957088|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957089|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957090|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957091|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957092|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957093|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957094|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957095|NCT00935532|O2|Outcome|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957096|NCT00935532|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957097|NCT00935532|E2|Reported Event|Insulin Glargine|Subcutaneous injection, titrated to achieve fasting serum glucose target, once a day
957098|NCT00935532|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection, 2.0mg, once a week.
957099|NCT00935493|B4|Baseline|Total|Total of all reporting groups
957100|NCT00935493|B3|Baseline|Placebo po Qhs|Placebo: Placebo po qhs
957101|NCT00935493|B2|Baseline|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
957102|NCT00935493|B1|Baseline|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
957103|NCT00935493|P3|Participant Flow|Placebo po Qhs|Placebo: Placebo po qhs
957104|NCT00935493|P2|Participant Flow|Guanfacine 0.5 mg po Qhs|Guanfacine: Guanfacine 0.5 mg po qhs
957105|NCT00935493|P1|Participant Flow|Guanfacine 0.1 mg po Qhs|Guanfacine: Guanfacine 0.1 mg po qhs
957106|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
957107|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
957108|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
957109|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
957110|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
957111|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
957112|NCT00935493|O3|Outcome|Placebo|Placebo: Placebo
957113|NCT00935493|O2|Outcome|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
957114|NCT00935493|O1|Outcome|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
957115|NCT00935493|E3|Reported Event|Placebo|Placebo: Placebo
957116|NCT00935493|E2|Reported Event|Guanfacine 0.5 mg|Guanfacine: Guanfacine 0.5 mg
957117|NCT00935493|E1|Reported Event|Guanfacine 0.1 mg|Guanfacine: Guanfacine 0.1 mg
957118|NCT00935311|B4|Baseline|Total|Total of all reporting groups
957119|NCT00935311|B3|Baseline|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957120|NCT00935311|B2|Baseline|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
957121|NCT00935311|B1|Baseline|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957122|NCT00935311|P3|Participant Flow|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957123|NCT00935311|P2|Participant Flow|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
957124|NCT00935311|P1|Participant Flow|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957125|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957126|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
957127|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957128|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957129|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
957130|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957131|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957132|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
957133|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957134|NCT00935311|O3|Outcome|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957177|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957135|NCT00935311|O2|Outcome|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
957136|NCT00935311|O1|Outcome|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957187|NCT00935064|O1|Outcome|Aliskiren|300 mg, once daily, for 6 weeks
957137|NCT00935311|E3|Reported Event|Placebo|2 doses of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957138|NCT00935311|E2|Reported Event|Hydrocodone/Acetaminophen|2 doses of 1 hydrocodone/acetaminophen immediate-release tablet plus 1 placebo tablet, administered once every 6 hours for 12 hours (for a total of 2 doses).
957139|NCT00935311|E1|Reported Event|ABT-712|1 dose of 1 ABT-712 extended-release tablet plus 1 placebo tablet, followed by 1 dose of 2 placebo tablets, administered once every 6 hours for 12 hours (for a total of 2 doses).
957140|NCT00935272|B3|Baseline|Total|Total of all reporting groups
957141|NCT00935272|B2|Baseline|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
957142|NCT00935272|B1|Baseline|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
957143|NCT00935272|P2|Participant Flow|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
957144|NCT00935272|P1|Participant Flow|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
957145|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
957146|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
957147|NCT00935272|O2|Outcome|No Treatment|Subjects who received no treatment, for comparison purposes, for the primary efficacy and safety analysis
957148|NCT00935272|O1|Outcome|Treatment With Restylane|Restylane is composed of a clear, colorless and transparent gel in sterile 1.0 mL syringes. It is supplied with a sterilized 30G x ½ inch needle. The number of syringes used depends on the amount needed to achieve optimal lip augmentation. Optimal lip augmentation is defined as the best possible aesthetic result that can be obtained. Treatment will occur on day 1, with an optional 2 week touch-up at the investigator's and patient's discretion.
957149|NCT00935272|E3|Reported Event|Second Treatment|At Week 24, subjects who were initially randomized to treatment were offered an optional second treatment with Restylane. In addition those randomized to non-treatment were offered their first treatment of Restylane at week 24. The safety from this set was followed to one month after the treatment.
957150|NCT00935272|E2|Reported Event|No Treatment|Safety included post treatment assessment, and assessments at each visit throughout the study.
957151|NCT00935272|E1|Reported Event|Treatment With Restylane|Safety included post treatment assessment, and assessments at each visit throughout the study.
957152|NCT00935259|B1|Baseline|All Participants|All enrolled participants
957153|NCT00935259|P2|Participant Flow|Placebo First, Then Simvastatin 40 mg|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
957154|NCT00935259|P1|Participant Flow|Simvastatin 40 mg, Then Placebo|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
957155|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
957156|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
957157|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
957158|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
957159|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
957160|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
957161|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by Simvastatin 40 mg once daily for 2 weeks
957162|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo for 2 weeks
957163|NCT00935259|O2|Outcome|Placebo|Placebo once daily for 2 weeks followed by simvastatin 40 mg daily for 2 weeks
957164|NCT00935259|O1|Outcome|Simvastatin 40 mg|Simvastatin 40 mg once daily for 2 weeks followed by placebo once daily for 2 weeks
957165|NCT00935259|E2|Reported Event|Placebo|Placebo to simvastatin tablets once daily for 2 weeks in either Period 1 or Period 2
957166|NCT00935259|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablets once daily for 2 weeks in either Period 1 or Period 2
957167|NCT00935220|B1|Baseline|Linagliptin 5mg|Linagliptin 5mg once daily
957168|NCT00935220|P1|Participant Flow|Linagliptin 5mg|Linagliptin 5mg once daily
957169|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957170|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957171|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957172|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957173|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957174|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957175|NCT00935220|O1|Outcome|Linagliptin 5mg|Linagliptin 5mg once daily
957178|NCT00935220|E1|Reported Event|Linagliptin 5mg|Linagliptin 5mg once daily
957179|NCT00935064|B3|Baseline|Total|Total of all reporting groups
957180|NCT00935064|B2|Baseline|Placebo|Once daily, for 6 weeks
957181|NCT00935064|B1|Baseline|Aliskiren|300 mg, once daily, for 6 weeks
957182|NCT00935064|P2|Participant Flow|Placebo|Once daily, for 6 weeks
957195|NCT00935064|E1|Reported Event|Aliskiren|300 mg, once daily, for 6 weeks
957196|NCT00934947|B3|Baseline|Total|Total of all reporting groups
957197|NCT00934947|B2|Baseline|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
957198|NCT00934947|B1|Baseline|Sugar Pill|Identical to active drug in sight, taste, and smell.
957199|NCT00934947|P2|Participant Flow|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
957200|NCT00934947|P1|Participant Flow|Sugar Pill|Identical to active drug in sight, taste, and smell.
957201|NCT00934947|O2|Outcome|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
957202|NCT00934947|O1|Outcome|Sugar Pill|Identical to active drug in sight, taste, and smell.
957203|NCT00934947|E2|Reported Event|Propranolol, Propanolol ER|Identical to sugar pill in sight, taste, and smell.
957204|NCT00934947|E1|Reported Event|Sugar Pill|Identical to active drug in sight, taste, and smell.
957205|NCT00934856|B7|Baseline|Total|Total of all reporting groups
957206|NCT00934856|B6|Baseline|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957207|NCT00934856|B5|Baseline|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957208|NCT00934856|B4|Baseline|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957209|NCT00934856|B3|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957210|NCT00934856|B2|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957211|NCT00934856|B1|Baseline|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957212|NCT00934856|P6|Participant Flow|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957213|NCT00934856|P5|Participant Flow|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957214|NCT00934856|P4|Participant Flow|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957215|NCT00934856|P3|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957264|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957216|NCT00934856|P2|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957217|NCT00934856|P1|Participant Flow|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with human epidermal growth factor receptor 2 (HER2)-positive MBC received docetaxel (Doc) 75 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 and trastuzumab emtansine (T-DM1) 2.4 milligrams per kilogram (mg/kg) IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957218|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
957219|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
957220|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
957221|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
957222|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
957223|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
957224|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
957225|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
957226|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
957227|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
957228|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
957229|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
957230|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
957231|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
957232|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
957233|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
957234|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
957235|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
957236|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
957237|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
957238|NCT00934856|O5|Outcome|LABC: Docetaxel 100 mg/m^2|All LABC participants who received docetaxel 100 mg/m^2 IV infusion.
957239|NCT00934856|O4|Outcome|LABC: Docetaxel 75 mg/m^2|All LABC participants who received docetaxel 75 mg/m^2 IV infusion.
957240|NCT00934856|O3|Outcome|LABC: Docetaxel 60 mg/m^2|All LABC participants who received docetaxel 60 mg/m^2 IV infusion.
957241|NCT00934856|O2|Outcome|MBC: Docetaxel 60 mg/m^2|All MBC participants who received docetaxel 60 mg/m^2 IV infusion.
957242|NCT00934856|O1|Outcome|MBC: Docetaxel 75 mg/m^2|All MBC participants who received docetaxel 75 mg/m^2 IV infusion.
957243|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957244|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957245|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957246|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957247|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957248|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957249|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957250|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957251|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957252|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957253|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957254|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957255|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957256|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957257|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957258|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957259|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957260|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957261|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957262|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957263|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957265|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957266|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957267|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957268|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957269|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957270|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957271|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957272|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957273|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957274|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957275|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
961710|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
957276|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957277|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957278|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957279|NCT00934856|O3|Outcome|LABC: T-DM1 3.6 mg/kg|All LABC participants who received T-DM1 3.6 mg/kg IV infusion.
957280|NCT00934856|O2|Outcome|MBC: T-DM1 3.6 mg/kg|All MBC participants who received T-DM1 3.6 mg/kg IV infusion.
957281|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg|All MBC participants who received T-DM1 2.4 mg/kg IV infusion.
957282|NCT00934856|O1|Outcome|Overall MBC and LABC Participants|All enrolled participants who received at least one dose of study medication
957283|NCT00934856|O2|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957284|NCT00934856|O1|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957285|NCT00934856|O2|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957286|NCT00934856|O1|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957287|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
957288|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
957289|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
957290|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
957291|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
957292|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
957293|NCT00934856|O1|Outcome|Overall MBC Participants|Participants with MBC who were enrolled in the study and who received at least one dose of study medication
957294|NCT00934856|O6|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957295|NCT00934856|O5|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957296|NCT00934856|O4|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957297|NCT00934856|O3|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957298|NCT00934856|O2|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957299|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957300|NCT00934856|O6|Outcome|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957301|NCT00934856|O5|Outcome|LABC: T-DM1 + Doc (Doublet Regimen)|Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957621|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
961711|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
957302|NCT00934856|O4|Outcome|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957303|NCT00934856|O3|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957304|NCT00934856|O2|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957305|NCT00934856|O1|Outcome|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957306|NCT00934856|E6|Reported Event|LABC: T-DM1 + Doc + Pertuzumab (Triplet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg Iv infusion, docetaxel 60/75 mg/m^2 IV infusion, and pertuzumab 840 mg (for Cycle 1) or 420 mg (for remaining cycles) IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957307|NCT00934856|E5|Reported Event|LABC: T-DM1 + Doc (Doublet Regimen)|Feasibility and extension part: Participants with HER2-positive LABC received T-DM1 3.6 mg/kg IV infusion and docetaxel 60/75/100 mg/m^2 IV infusion on Day 1 of each 3-week cycle, for 6 cycles. Study treatment was administered for up to 6 cycles or until unacceptable toxicity, and prior to surgery.
957308|NCT00934856|E4|Reported Event|MBC: T-DM1 3.6 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility and extension part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 3.6 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 3.6 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957309|NCT00934856|E3|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Same Day)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion and T-DM1 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957310|NCT00934856|E2|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 60 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 60 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 60 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 60 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957311|NCT00934856|E1|Reported Event|MBC: T-DM1 2.4 mg/kg + Doc 75 mg/m^2 (Over 2 Days)|Feasibility part: Participants with HER2-positive MBC received docetaxel 75 mg/m^2 IV infusion on Day 1 and T-DM1 2.4 mg/kg IV infusion on Day 2 of Cycle 1 followed by T-DM1 75 mg/m^2 and docetaxel 2.4 mg/kg IV infusion on Day 1 of each 3-week cycle for a minimum of 6 cycles. After 6 cycles, docetaxel 75 mg/m^2 was stopped and T-DM1 2.4 mg/kg was continued until confirmed evidence of disease progression, unacceptable toxicity, or withdrawal of participant consent.
957312|NCT00934843|B3|Baseline|Total|Total of all reporting groups
957313|NCT00934843|B2|Baseline|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
957314|NCT00934843|B1|Baseline|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
957315|NCT00934843|P2|Participant Flow|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
957316|NCT00934843|P1|Participant Flow|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
957609|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957317|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
957318|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
957319|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
957320|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
957321|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
957322|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
961712|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
957323|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
957324|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
957325|NCT00934843|O2|Outcome|MP Two Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Two Dose (8 hours preoperatively and operatively) methylprednisolone (30 mg/kg/dose).
957326|NCT00934843|O1|Outcome|MP Single Dose|Neonates scheduled for cardiac surgery that were randomly assigned to receive Single Dose (operatively) methylprednisolone (30 mg/kg/dose)
957327|NCT00934843|E2|Reported Event|MP Two Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive TWO (8 hours preoperatively and operatively) doses intravenous methylprednisolone (IVMP, 30 mg/kg/dose) prior to heart surgery.
957328|NCT00934843|E1|Reported Event|MP Single Dose|Neonates with congenital heart disease requiring surgery utilizing a cardiopulmonary bypass (CPB) machine in the first month of life that receive ONE dose (operatively)intravenous methylprednisolone (IVMP, 30 mg/kg) prior to heart surgery.
957329|NCT00934791|B3|Baseline|Total|Total of all reporting groups
957330|NCT00934791|B2|Baseline|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
957331|NCT00934791|B1|Baseline|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
957332|NCT00934791|P2|Participant Flow|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
957333|NCT00934791|P1|Participant Flow|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
957334|NCT00934791|O2|Outcome|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
957335|NCT00934791|O1|Outcome|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
957336|NCT00934791|E2|Reported Event|Sirolimus Group|Sirolimus, mycophenolate mofetil, and prednisone
957337|NCT00934791|E1|Reported Event|Control Group|Tacrolimus, mycophenolate mofetil, and prednisone
957338|NCT00934648|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
957339|NCT00934648|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg administered intravenously (IV) and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background methotrexate (MTX) 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
957340|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
957341|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
957342|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
957343|NCT00934648|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
957344|NCT00934648|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg administered IV and methylprednisolone 100 mg, IV, on Days 1 and 15; all participants were receiving background MTX 10-25 mg weekly by mouth or parenterally per local prescribing guidelines.
957345|NCT00934635|B10|Baseline|Total|Total of all reporting groups
957346|NCT00934635|B9|Baseline|Control|PET Scan Control
957347|NCT00934635|B8|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957348|NCT00934635|B7|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957349|NCT00934635|B6|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
957350|NCT00934635|B5|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
957351|NCT00934635|B4|Baseline|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
957352|NCT00934635|B3|Baseline|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957353|NCT00934635|B2|Baseline|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957354|NCT00934635|B1|Baseline|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957355|NCT00934635|P9|Participant Flow|Control|PET Scan Control
957356|NCT00934635|P8|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957357|NCT00934635|P7|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957358|NCT00934635|P6|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
957359|NCT00934635|P5|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
957622|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957360|NCT00934635|P4|Participant Flow|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
957361|NCT00934635|P3|Participant Flow|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957362|NCT00934635|P2|Participant Flow|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957363|NCT00934635|P1|Participant Flow|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957364|NCT00934635|O9|Outcome|Control|PET Scan Control
957365|NCT00934635|O8|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957366|NCT00934635|O7|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957367|NCT00934635|O6|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
957368|NCT00934635|O5|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
957369|NCT00934635|O4|Outcome|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
957370|NCT00934635|O3|Outcome|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957371|NCT00934635|O2|Outcome|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957372|NCT00934635|O1|Outcome|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957373|NCT00934635|E9|Reported Event|Control|PET Scan Control
957374|NCT00934635|E8|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 6 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957375|NCT00934635|E7|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 24 Hours|Oral risperidone 4 mg tablet once a day (1 day intake; 1 day off) followed by PET scan in approximately 24 hours
957376|NCT00934635|E6|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 9 mg tablet once a day (1 day intake, 1 day off) followed by PET scan in approximately 24 hours
957377|NCT00934635|E5|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 24 Hours|Paliperidone ER 6 mg tablet once a day (1 day intake, one day off) followed by PET scan in 24 hours
957378|NCT00934635|E4|Reported Event|Oral Risperidone 6 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 6 mg tablet once a day (for 2 days)followed by PET scan in approximately 2 hours
957379|NCT00934635|E3|Reported Event|Oral Risperidone 4 mg Tablet Followed by PET Scan in 2 Hours|Oral risperidone 4 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957380|NCT00934635|E2|Reported Event|Paliperidone ER 9 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 9 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957381|NCT00934635|E1|Reported Event|Paliperidone ER 6 mg Tablet Followed by PET Scan in 2 Hours|Paliperidone ER 6 mg tablet once a day (for 2 days) followed by PET scan in approximately 2 hours
957382|NCT00934622|B1|Baseline|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
957383|NCT00934622|P1|Participant Flow|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
957384|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
957385|NCT00934622|O1|Outcome|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
957386|NCT00934622|E1|Reported Event|AcrySof® ReSTOR® Aspheric IOL|AcrySof® ReSTOR® Aspheric Intraocular Lens (IOL)
957387|NCT00934596|B3|Baseline|Total|Total of all reporting groups
957388|NCT00934596|B2|Baseline|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before cannulation, CO2 was insufflated in the mediastinum at a flow rate of 10 litres/minute and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively re-filled with blood and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under transesophageal echocardiographic (TEE) monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to eject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957610|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957611|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957389|NCT00934596|B1|Baseline|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. Hereafter the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart defibrillated. After a good cardiac contraction and normal central hemodynamics were established, the LV preload was gradually and successively increased. When no air emboli were observed in the left side of the heart by transesophageal echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957623|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957390|NCT00934596|P2|Participant Flow|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the carbon-dioxide(CO2) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completed surgery, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957391|NCT00934596|P1|Participant Flow|Lund De-airing Technique|Before cardiopulmonary bypass (CPB) was established, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart by Trans-esophageal Echocardiography (TEE), the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957392|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957393|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957394|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957395|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957434|NCT00934544|E1|Reported Event|INC424/INCB018424|"The starting dose of ruxolitinib tablets was determined based on baseline platelet count as follows: Subjects with baseline platelet count > 200, 000/µL began dosing at 20 mg bid (four 5 mg tablets bid) or Subjects with baseline platelet count of 100,000/µL to 200,000/µL (inclusive) began dosing at 15 mg bid (three 5 mg tablets bid).~A standardized dosing paradigm was used to determine dose adjustments for safety and efficacy so that each subject was titrated to their most appropriate dose."
957612|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957396|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
961713|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
957397|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957398|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
957399|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957400|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957401|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957402|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957435|NCT00934440|B1|Baseline|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
957525|NCT00934050|B3|Baseline|1000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957403|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957404|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957405|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957406|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957407|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957408|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
957409|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957436|NCT00934440|P1|Participant Flow|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
957526|NCT00934050|B2|Baseline|250mg BID/2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
958703|NCT00930761|O2|Outcome|Music Therapy|
957417|NCT00934596|E1|Reported Event|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957410|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957411|NCT00934596|O1|Outcome|Lund De-airing|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957412|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957413|NCT00934596|O1|Outcome|Lund De-airing Technique|Before CPB was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The deairing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957414|NCT00934596|O2|Outcome|Carbon-dioxide Insufflation Technique|The pleural cavities were left intact in the CO2 (carbon-dioxide) group. During cardiopulmonary bypass (CPB), the patient was administered dead space ventilation. Before CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from C
957415|NCT00934596|O1|Outcome|Lund De-airing Technique|Before cardiopulmonary bypass(CPB) was started, both pleural cavities were exposed to atmospheric air through small openings in the mediastinal pleurae. After CPB was established the patient was disconnected from the ventilator, allowing both lungs to collapse. After completion of the surgical procedure the aortic crossclamp was released and the heart was then defibrillated. After a good cardiac contraction and normal central hemodynamics, the LV preload was gradually and successively. When no air emboli were observed in the left side of the heart, the patient was reconnected to the ventilator and the lungs were ventilated with half of the estimated minute volume using 100% oxygen and 5 cm H2O positive end-expiratory pressure. The de-airing was continued, and when no air emboli were observed in the left side of the heart, the lungs were ventilated to full capacity and the heart was allowed to eject by reducing the LV vent.
957416|NCT00934596|E2|Reported Event|Carbon-dioxide Insufflation|The pleural cavities were left intact in the CO2 group. During CPB, the patient was administerd dead space ventilation. Before the cannulation for CPB, the CO2 was insufflated in the mediastinum at a flow rate of 10 L/min and continued until 10 minutes post-CPB. After completion of the surgical procedure, the heart and lungs were passively filled with blood from the CPB circuit and the left side was de-aired continuously through the LV apical vent. Full ventilation was then resumed. The heart was defibrillated and the LV preload was gradually and successively increased by reducing the venous return to the CPB circuit. The de-airing continued through the vent in the LV apex under TEE monitoring. When no gas emboli were observed in the left side of the heart, the LV vent was reduced and the heart was allowed to ject. De-airing was continued, and when no further gas emboli were observed in the left side of the heart, the patient was weaned from CPB.
957476|NCT00934141|P4|Participant Flow|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
957477|NCT00934141|P3|Participant Flow|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
957601|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957419|NCT00934544|B2|Baseline|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
957420|NCT00934544|B1|Baseline|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
957421|NCT00934544|P2|Participant Flow|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
957422|NCT00934544|P1|Participant Flow|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
957423|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, or no therapy, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) was used.
957424|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg twice daily (BID) or 20 mg BID were selected with starting dose based on baseline platelet count. Starting dose was either 15 mg BID or 20 mg BID based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
957425|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
957426|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
957427|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
957428|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
957429|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
957430|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
957431|NCT00934544|O2|Outcome|Best Available Therapy (BAT)|Best-available Investigator-selected therapy included a combination of available agents to treat the disease and/or its symptoms, and was selected by the investigator for each subject. Therapy changed at different times during the treatment phase. No experimental agents (e.g. those not approved for the treatment of any indication) were allowed. BAT also included the option of no treatment.
957432|NCT00934544|O1|Outcome|INC424/INCB018424|Starting dose of 15 mg BID or 20 mg BID were selected with starting dose based on baseline platelet count. Dose titration ranging from 5 mg BID to a maximum dose of 25 mg BID was permitted during the study based on safety and efficacy. Tablets were to be taken 12 hours apart. Administration instructions were provided at study visits.
957433|NCT00934544|E2|Reported Event|Best Available Therapy (BAT)|Best Available Therapy (BAT) was prescribed at doses and schedules selected by the Investigator on a subject-by-subject basis. BAT could include a single agent, combination of agents for the treatment of the disease and its symptoms or no therapy. Therapy could be changed at any time during the study EXCEPT during the screening period. No experimental drugs were permitted during the study.
957602|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957437|NCT00934440|O1|Outcome|Dose Escalation: 5-azacitidine|"A traditional 3+3 dose escalation trial was implemented. Successive cohorts of patients (3 participants/cohort) received bevacizumab at the standard dose of 10mg/kg in combination with escalating doses of 5-azacitidine. If no dose limiting toxicity (DLT) is seen, subsequent patients will be treated at the next dose level. If one DLT is seen, an additional three patients will be accrued at that dose level. If two or more DLTs are seen at one dose level, then the previous dose level will be chosen for phase IIA. If two DLT’s are seen at dose level 1, the trial will end. The standard 5-azacitidine dose is 75mg/m2/day for 7 days. If no DLT is seen at dose level 3, then we will proceed with the phase IIA portion of the study.~Bevacizumab:~First treatment: 10 milligram per kilograms (MG/KG) intravenously (IV) on Day 1~Second treatment: 10 MG/KG IV on Day 1~Third and subsequent treatments: 10 MG/KG IV on Day 1"
957438|NCT00934440|O1|Outcome|5-Azacitidine Maximum Tolerated Dose (MTD)|
957439|NCT00934440|E1|Reported Event|Phase I 5-Azacitidine Maximum Tolerated Dose (MTD)|All patients in phase I and II will receive bevacizumab at the standard dose of 10mg/kg IV every two weeks. The first dose should be infused over 90 minutes. If no adverse reactions occur, the second dose of bevacizumab should be given over a minimum of 60 minutes. If no adverse event occurs, third and subsequent doses should be administered over a minimum of 30 minutes.
957440|NCT00934375|B3|Baseline|Total|Total of all reporting groups
957441|NCT00934375|B2|Baseline|Placebo|
957442|NCT00934375|B1|Baseline|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
957443|NCT00934375|P2|Participant Flow|Placebo|
957444|NCT00934375|P1|Participant Flow|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
957445|NCT00934375|O2|Outcome|Placebo|
957446|NCT00934375|O1|Outcome|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
957447|NCT00934375|E2|Reported Event|Placebo|
957448|NCT00934375|E1|Reported Event|Donepezil|5 mg or 10 mg of donepezil hydrochloride (Aricept) taken orally once a day.
957449|NCT00934362|B3|Baseline|Total|Total of all reporting groups
957450|NCT00934362|B2|Baseline|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
957451|NCT00934362|B1|Baseline|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
957452|NCT00934362|P2|Participant Flow|Placebo First, Then Lucinactant|0.9% NaCl x 6 ml (5 doses) then 20 mg/ml x 6 ml lucinactant (5 doses)
957453|NCT00934362|P1|Participant Flow|Lucinactant First, Then Placebo|20 mg/ml x 6 ml (5 doses) lucinactant then 0.9% NaCl x 6 ml (5 doses)
957454|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
957455|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
957456|NCT00934362|O2|Outcome|Placebo|0.9% NaCl x 6 ml (5 doses)
957457|NCT00934362|O1|Outcome|Lucinactant|20 mg/ml x 6 ml lucinactant (5 doses)
957458|NCT00934362|E2|Reported Event|Placebo|0.9% NaCl x 6 ml (5 doses)
957459|NCT00934362|E1|Reported Event|Lucinactant|20 mg/ml x 6 ml (5 doses)
957460|NCT00934180|B3|Baseline|Total|Total of all reporting groups
957461|NCT00934180|B2|Baseline|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
957462|NCT00934180|B1|Baseline|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
957463|NCT00934180|P2|Participant Flow|Zofran® (Reference) First|Zofran® 8 mg ODT (reference) dosed in first period followed by Ondansetron HCl 8 mg OD Tablet (test) dosed in second period
957464|NCT00934180|P1|Participant Flow|Ondansetron (Test) First|Ondansetron HCl 8 mg OD Tablet (test) dosed in first period followed by Zofran® 8 mg ODT (reference) dosed in second period
957465|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
957466|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
957467|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
957468|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
957469|NCT00934180|O2|Outcome|Zofran®|Zofran® 8 mg ODT (reference) dosed in either period
957470|NCT00934180|O1|Outcome|Ondansetron|Ondansetron HCl 8 mg OD Tablet (test) dosed in either period
957471|NCT00934141|B5|Baseline|Total|Total of all reporting groups
957472|NCT00934141|B4|Baseline|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
957473|NCT00934141|B3|Baseline|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
957474|NCT00934141|B2|Baseline|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
957475|NCT00934141|B1|Baseline|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
957524|NCT00934050|B4|Baseline|2000mg BID/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND05 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957478|NCT00934141|P2|Participant Flow|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
957528|NCT00934050|P6|Participant Flow|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957624|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957479|NCT00934141|P1|Participant Flow|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
957480|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
957481|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
957482|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
957483|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
957484|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
957485|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
957486|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
957487|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
957488|NCT00934141|O4|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
957489|NCT00934141|O3|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
957490|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
957491|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
957492|NCT00934141|O4|Outcome|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
957493|NCT00934141|O3|Outcome|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
957603|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
958704|NCT00930761|O1|Outcome|Control|
957494|NCT00934141|O2|Outcome|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
957495|NCT00934141|O1|Outcome|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
957496|NCT00934141|E4|Reported Event|Learning Session + Website|Learning Sessions occur bi-annually as change teams convene to learn and gather support from each other and outside experts who offer advice on how best to adopt the innovations and learn about new directions for the collaborative (e.g., the need to create business cases for improvements). Learning Sessions and Interest Circles (see below) have similar objectives—to help agencies learn and gather support from each other and from outside experts.
957497|NCT00934141|E3|Reported Event|Full: LS, Coaching, ICC, Website|Learning Session, Coaching, Interest Circle Calls, Website, see descriptions above
957498|NCT00934141|E2|Reported Event|Coaching + Website|Coaching assigns an expert in process improvement to work with an agency to make, sustain, and spread process improvement efforts. Consultations focus on executive directors, change leaders and improvement teams. Coaches help agencies address key issues, but also broker relationships with other agencies, offer process improvement training, and promote the innovations to make and how to make them. Coaching takes place during site visits, monthly phone conferences, and via email.
957499|NCT00934141|E1|Reported Event|Interest Circle Call + Website|Interest Circles are monthly teleconferences where agency change leaders discuss change-related issues and progress. Circles address how to improve timeliness, continuation, admissions, dropouts and transitions. They also address specialty topics (e.g., programs for women, adolescents). Participants discuss successes, failures, and challenges, and get advice and assignments for their improvement plans. Meeting summaries appear on the Web site. Interest Circles are inexpensive, but are they are sufficient? Should Interest Circles prove effective, they would provide a low-cost, convenient diffusion approach.
957500|NCT00934128|B3|Baseline|Total|Total of all reporting groups
957501|NCT00934128|B2|Baseline|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
957502|NCT00934128|B1|Baseline|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
957503|NCT00934128|P2|Participant Flow|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
957504|NCT00934128|P1|Participant Flow|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then high flow oxygen (HFO) delivery using Vapotherm device.
957505|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
957506|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
957507|NCT00934128|O2|Outcome|Group 2: Vapotherm Then BiPAP|Vapotherm air delivery then BiPAP.
957508|NCT00934128|O1|Outcome|Group 1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) then Vapotherm air delivery.
957509|NCT00934128|E2|Reported Event|Group 2: Vapotherm Then BiPAP|Vapotherm device air delivery then Bilevel positive airway pressure device (BiPAP) air delivery.
957510|NCT00934128|E1|Reported Event|Group1: BiPAP Then Vapotherm|Bilevel positive airway pressure device (BiPAP) air delivery then Vapotherm device air delivery.
957511|NCT00934102|B1|Baseline|Overall|This reporting group includes all subjects who were screened for the study, whether or not they subsequently were dispensed.
957512|NCT00934102|P3|Participant Flow|Lotrafilcon A / Galyfilcon A|Lotrafilcon A commercial contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
957513|NCT00934102|P2|Participant Flow|Narafilcon A / Galyfilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Galyfilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
957514|NCT00934102|P1|Participant Flow|Narafilcon A / Lotrafilcon A|Narafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
957515|NCT00934102|O3|Outcome|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
957516|NCT00934102|O2|Outcome|Narafilcon A|Investigational, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
957517|NCT00934102|O1|Outcome|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
957518|NCT00934102|E3|Reported Event|Galyfilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
957519|NCT00934102|E2|Reported Event|Narafilcon A|Experimental, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
957520|NCT00934102|E1|Reported Event|Lotrafilcon A|Commercially marketed, silicone hydrogel, spherical soft contact lens, worn on an extended wear basis.
957521|NCT00934050|B7|Baseline|Total|Total of all reporting groups
957522|NCT00934050|B6|Baseline|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957523|NCT00934050|B5|Baseline|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957604|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957605|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957527|NCT00934050|B1|Baseline|Placebo/2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957616|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957617|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957529|NCT00934050|P5|Participant Flow|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957530|NCT00934050|P4|Participant Flow|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957531|NCT00934050|P3|Participant Flow|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957532|NCT00934050|P2|Participant Flow|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957533|NCT00934050|P1|Participant Flow|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957534|NCT00934050|O2|Outcome|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957535|NCT00934050|O1|Outcome|Placebo/ELND005 250mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957536|NCT00934050|E6|Reported Event|250 mg/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957537|NCT00934050|E5|Reported Event|Placebo/ELND005 250 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up after 15 Dec 2009 were assigned to receive ELND005 250 mg PO BID for 48 weeks.
957538|NCT00934050|E4|Reported Event|2000 mg ELND005/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 2000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957539|NCT00934050|E3|Reported Event|1000 mg/ELND005 2000 mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 1000 mg PO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957540|NCT00934050|E2|Reported Event|250mg/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive ELND005 250 mgPO BID for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957541|NCT00934050|E1|Reported Event|Placebo/ELND005 2000mg BID|In the original randomized and blinded clinical trial (ELND005-AD201 NCT00568776) participants were randomized to receive Placebo for 78 weeks. Participants enrolled in ELND005-AD251 long term follow-up prior to 15 Dec 2009 were assigned to receive ELND005 2000 mg PO BID for 48 weeks.
957542|NCT00933933|B6|Baseline|Total|Total of all reporting groups
957543|NCT00933933|B5|Baseline|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from individuals at increased risk for HIV infection under a separate specimen collection protocol (pregant females 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
957544|NCT00933933|B4|Baseline|Architect HIV Ag/Ab Combo HIV-2 Antibody Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
957545|NCT00933933|B3|Baseline|Architect Ag/Ab Combo HIV-1 Antibody Sensitivity|Specimens collected from HIV-1 infected individuals under a separate specimen collection protocol (pediatric subjects 7B5-02-05Z01-02) or obtained from specimen vendors and were tested with investigational HIV test.
957546|NCT00933933|B2|Baseline|Architect HIV Ag/Ab Combo HIV-1 Antigen Sensitivity|Specimens obtained from specimen vendors were tested with investigational HIV test.
957547|NCT00933933|B1|Baseline|Architect HIV Ag/Ab Combo Specificity|Specimens collected from apparently healthy individuals under a separate specimen collection protocol (7B5-02-05Z01-01) or obtained from specimen vendors and were tested with investigational HIV test.
957548|NCT00933933|P3|Participant Flow|Architect HIV Ag/Ab Combo Reactivity|"Reactivty populations included:~1206 specimens collected from individuals at increased risk for HIV infection (16-89 years of age) from US and Cote D'Ivoire.~203 specimen from pregnant females at risk for HIV infection.~Of these 1409 specimens, 61 were collected from individual that were from 16 up to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
957606|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957607|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957549|NCT00933933|P2|Participant Flow|Architect HIV Ag/Ab Combo Sensitivity|"Sensitivity populations included:~1287 specimens or commercial panel members HIV-1 p24 Antigen positive, specimens confirmed HIV-1 antibody positive and specimens confirmed HIV-2 antibody positive.~67 specimens from pregnant females from all three trimesters confirmed HIV posiitve by supplemental testing.~64 specimens from pediatric subjects confirmed HIV positive by supplemental testing (2 to 21 years of age).~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigational HIV test."
957618|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957550|NCT00933933|P1|Participant Flow|Architect HIV Ag/Ab Combo Specificity|"Specificity populations included:~6164 specimens collected from apparently healthy individuals at low risk for HIV infection (16-89 years of age) which includes 250 specimens from pregnant females in first trimester of pregnancy.~448 specimen from presumed HIV negative pregnant females from 16 to 44 years of age.~588 specimen from pediatric presumed negative for HIV from 2 to 21 years of age.~Specimens were collected under separate collection protocols or by specimens vendors and tested with investigation HIV test."
957551|NCT00933933|O3|Outcome|Reactivity in Pregnant Female Population|Specimens collected from 203 pregnant females: 153 specimens collected from pregnant females with documented risk factors for HIV and 50 were surplus serum specimens collected pregnant females from a health clinic offering HIV testing. Spcimens from 55 of the pregnant females with risk for HIV infection were collected under a specimen collection protocol and tested with the investigational and FDA-licensed comparator assay during the study. The remaining specimens were obtained from specimen vendors and tested with the investigational HIV test.
957552|NCT00933933|O2|Outcome|Increased Risk for HIV From HIV-2 Endemic Area|Specimens from 513 individuals documented as being at risk for acquiring HIV that reside in an HIV-2 endemic area (Cote De'Ivoire) having one or more of the following risk factors: unprotected sex with someone who is infected with HIV, multiple sex partners, men who have sex with men, users of injecting drugs. Specimens were obtained from specimen vendors and tested with investigational HIV test.
957553|NCT00933933|O1|Outcome|Increased Risk for HIV in US Population|Specimens collected from 693 individuals in the US population documented as having one or more of the following risk factors: users of injecting drugs, unprotected sex with someone who is infected with HIV, diagnosed or treated for a sexually transmitted disease (STD), hepatitis or tuberculosis, multiple sex partners, men who have sex with men, men who have sex with men and are users of injecting drugs, unprotected sex with someone who has been diagnosed or treated for an STD, risk factor not identified but requested an HIV test. Specimens obtained from specimen vendors and were tested with investigational HIV test.
957554|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pediatric Population|Specimens confirmed HIV positive by HIV-1 Western blot were tested with investigational HIV test. Specimens from individuals between 2 and 21 years of age.
957555|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pediatric Population|Specimens presumed HIV negative tested with investigational HIV test, FDA-licensed comparator assay and supplemental tests. Specimens from individuals between 2 and 21 years of age.
957556|NCT00933933|O2|Outcome|Architect HIV Ag/Ab Combo Sensitivity in Pregnant Females|HIV confirmed positive specimens from pregnant females tested with investigation HIV test, comparator assay and supplement tests.
957557|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Combo Specificity in Pregnant Females|HIV presumed negative specimens from pregnant females tested with investigation HIV test, comparator assay and supplemental tests.
957558|NCT00933933|O3|Outcome|HIV-2 Antibody Sensitivity|Specimens collected from HIV infected individuals in Ivory Coast confirmed by HIV-2 Western blot.
957559|NCT00933933|O2|Outcome|HIV-1 Antibody Sensitivity|Specimens collected from HIV infected individuals in US population confirmed by HIV-1 Western blot.
957560|NCT00933933|O1|Outcome|HIV p24 Antgen Sensitivity|HIV-1 Antigen positive specimens/commercial panel members (HIV Westerm blot negative and confirmed positive by HIV-1 p24 Antigen and/or HIV RNA) and HIV-1 viral isolates.
957561|NCT00933933|O1|Outcome|Architect HIV Ag/Ab Specificity - Low Risk for HIV Infection|Specimens collected from a population of apparently healthy individuals at low risk for HIV infection.
957562|NCT00933933|E3|Reported Event|Architect HIV Ag/Ab Combo Reactivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
957563|NCT00933933|E2|Reported Event|Architect HIV Ag/Ab Combo Sensitivity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
957564|NCT00933933|E1|Reported Event|Architect HIV Ag/Ab Combo Specificity|Specimens collected from specimen vendors or from specimen collection studies were tested with investigation HIV test.
957565|NCT00933686|B3|Baseline|Total|Total of all reporting groups
957566|NCT00933686|B2|Baseline|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957567|NCT00933686|B1|Baseline|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957568|NCT00933686|P2|Participant Flow|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957569|NCT00933686|P1|Participant Flow|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957570|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957608|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957571|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957619|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957620|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957572|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957573|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957574|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957575|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957576|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957577|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957578|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957579|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957580|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957581|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957582|NCT00933686|O2|Outcome|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957583|NCT00933686|O1|Outcome|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957584|NCT00933686|E2|Reported Event|Placebo + Saizen®|Placebo matched to Saizen® was administered for the first 6 months followed by treatment with Saizen® (Somatropin) 0.006 mg/kg subcutaneously daily for next 6 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in IGF-1 was less than 50 percent of the baseline value. Dose titrations were made at Month 7 and 9.
957585|NCT00933686|E1|Reported Event|Saizen®|Saizen® (Somatropin) 0.006 milligram per kilogram (mg/kg) was administered subcutaneously daily for 12 months. Saizen® dose was titrated (an increase of 0.2 milligram per day) if the increase in insulin-like growth factor 1 (IGF-1) was less than 50 percent of the baseline value. Dose titrations were made at Month 1, 3, 7 and 9.
957586|NCT00933608|B3|Baseline|Total|Total of all reporting groups
957587|NCT00933608|B2|Baseline|Placebo|
957588|NCT00933608|B1|Baseline|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
957589|NCT00933608|P2|Participant Flow|Placebo|participants were taking 1 tablet twice a day to match memantine arm
957590|NCT00933608|P1|Participant Flow|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
957591|NCT00933608|O2|Outcome|Placebo|participant will be taking 1 tablet twice a day to match active arm
957592|NCT00933608|O1|Outcome|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
957593|NCT00933608|E2|Reported Event|Placebo|
957594|NCT00933608|E1|Reported Event|Memantine|memantine : participants will be asked to take memantine (20mg/day) for 16 weeks
957595|NCT00933543|B3|Baseline|Total|Total of all reporting groups
957596|NCT00933543|B2|Baseline|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957597|NCT00933543|B1|Baseline|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957598|NCT00933543|P2|Participant Flow|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957599|NCT00933543|P1|Participant Flow|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957600|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957613|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957614|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957615|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957625|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957626|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957627|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957628|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957629|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957630|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957631|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957632|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957633|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957634|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957635|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957636|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957637|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957638|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957639|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957640|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957641|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957642|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957643|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957644|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957645|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957646|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957647|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957648|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957649|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957650|NCT00933543|O2|Outcome|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957651|NCT00933543|O1|Outcome|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957652|NCT00933543|E2|Reported Event|Vehicle Cream With PDT|Placebo treatment, Light dose 37 J/cm2.
957653|NCT00933543|E1|Reported Event|Visonac Cream With PDT|Active treatment, Light dose 37 J/cm2.
957654|NCT00933491|B3|Baseline|Total|Total of all reporting groups
957655|NCT00933491|B2|Baseline|Control|Non-diabetics
957656|NCT00933491|B1|Baseline|Diabetic|Type II Diabetes
957657|NCT00933491|P2|Participant Flow|Control|Non-diabetics
957658|NCT00933491|P1|Participant Flow|Diabetic|Type II Diabetes
957659|NCT00933491|O2|Outcome|Control|Non-diabetics
957660|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
957661|NCT00933491|O2|Outcome|Control|Non-diabetics
957662|NCT00933491|O1|Outcome|Diabetic|Type II Diabetes
957663|NCT00933491|E2|Reported Event|Control|Non-diabetics
957664|NCT00933491|E1|Reported Event|Diabetic|Type II Diabetes
957665|NCT00933335|B3|Baseline|Total|Total of all reporting groups
957666|NCT00933335|B2|Baseline|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957667|NCT00933335|B1|Baseline|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
957749|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957750|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957668|NCT00933335|P2|Participant Flow|Fludarabine (3 Cycles); TST and Iodine I 131 TST|Participants (par.) received 3 cycles of IV fludarabine (FL) monophosphate (25 mg/m^2/day) for 5 days every 5-6 weeks. After receiving FL, par. meeting criteria received the dosimetric dose (DD), administered 6-8 weeks after the 3rd cycle of FL. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Par. received >=3 doses (4 drops by mouth [DBM], 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 DBM, TID) of Lugol’s solution, or KI tablets (130 mg BM, once a day) >=24 hrs prior to administration of the DD and continued daily for 14 days after the therapeutic dose (TD), administered 7-14 days after the DD. The TD was an IV infusion of 450 mg TST over 1 hr, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957669|NCT00933335|P1|Participant Flow|Received Less Than 3 Cycles of Fludarabine|Participants received less than 3 cycles of intravenous (IV) fludarabine monophosphate (25 milligrams/meter^2/day [mg/m^2/day]) for 5 days every 5 to 6 weeks.
958206|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
957670|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957671|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957672|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957673|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957674|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957675|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957751|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957752|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957932|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957676|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957695|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957949|NCT00932646|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957677|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957678|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957679|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957680|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957681|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957682|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957683|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957933|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957684|NCT00933335|O2|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957685|NCT00933335|O1|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957686|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957687|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957688|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957689|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957690|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957691|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957692|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957693|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957753|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957934|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957935|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957694|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957696|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957697|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957698|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957699|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957700|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957701|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957702|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957703|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957722|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957704|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957705|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957706|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957707|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957708|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957709|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957710|NCT00933335|O1|Outcome|Fludarabine/TST and Iodine I 131 TST|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957936|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958705|NCT00930761|O2|Outcome|Music Therapy|
957711|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957712|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957713|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957714|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957715|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957716|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957717|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957718|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957719|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957720|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957754|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957937|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957938|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957721|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957723|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957724|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957725|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957726|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957727|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957728|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957729|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957730|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957731|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957755|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
958706|NCT00930761|O1|Outcome|Control|
957732|NCT00933335|O3|Outcome|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957950|NCT00932646|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957733|NCT00933335|O2|Outcome|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol’s solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957734|NCT00933335|O1|Outcome|Fludarabine|Participants received 3 cycles of intravenous (IV) fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks.
957735|NCT00933335|E3|Reported Event|Fludarabine/TST and Iodine I 131 TST (Combined Regimen)|Participants received 3 cycles of IV fludarabine monophosphate (25 mg/m^2/day) for 5 days every 5 to 6 weeks. The DD was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled TST (450 mg) was infused over 1 hr prior to a 30 minute infusion of 35 mg TST trace labeled with 5 mCi iodine I 131. Participants received at least 3 doses (4 drops by mouth, TID) of a saturated solution KI, 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the TD. The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radio labeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 cGy over 20 minutes.
957736|NCT00933335|E2|Reported Event|TST and Iodine I 131 TST|The dosimetric dose (DD) was administered 6 to 8 weeks after the third cycle of fludarabine. IV administration of unlabeled tositumomab (TST) (450 mg) was infused over 1 hour (hr) prior to a 30 minute infusion of 35 mg TST trace labeled with 5 millicurie (mCi) iodine I 131. Participants received at least 3 doses (4 drops by mouth, 3 times a day [TID]) of a saturated solution of potassium iodide (KI), 3 doses (20 drops by mouth, TID) of Lugol's solution, or KI tablets (130 mg by mouth, once a day) 24 hrs or more prior to administration of the DD and continued daily for 14 days following the therapeutic dose (TD). The TD was administered 7 to 14 days after the dosimetric dose. The TD was an IV infusion of 450 mg TST over 1 hour, followed by infusion of 35 mg of TST radiolabeled with iodine I 131 to deliver the appropriate total body dose of 75, 65, or 45 centigray (cGy) over 20 minutes.
957737|NCT00933335|E1|Reported Event|Fludarabine|Participants who received any number of cycles of IV fludarabine monophosphate (25 mg/m^2/day). Each cycle was administered for 5 days every 5 to 6 weeks.
957738|NCT00933270|B1|Baseline|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957739|NCT00933270|P1|Participant Flow|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957740|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957741|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957742|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957743|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957744|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957745|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957746|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957747|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957748|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957939|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957756|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957757|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957758|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957951|NCT00932620|B3|Baseline|Total|Total of all reporting groups
957759|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957760|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957761|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957762|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957763|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957764|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957765|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957766|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957767|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957768|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957769|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957770|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957771|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957772|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957773|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957774|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957775|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957776|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957777|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957778|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957779|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957780|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957940|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958707|NCT00930761|O2|Outcome|Music Therapy|
957781|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957782|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957783|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957784|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957785|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957786|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957787|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957788|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957789|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957790|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957791|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957792|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957793|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957794|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957795|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957796|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957797|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957798|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957799|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957800|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957801|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957802|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957803|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957804|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957805|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957941|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958708|NCT00930761|O1|Outcome|Control|
957806|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957807|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957808|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957809|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957810|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957811|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957812|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957813|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957814|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957815|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957816|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957817|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957818|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957819|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957820|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957821|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957822|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957823|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957824|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957825|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957826|NCT00933270|O1|Outcome|Supera® Peripheral Stent System|"Implantation of Supera stent using the Supera® Peripheral Stent System~Supera® Peripheral Stent System: Percutaneous Angioplasty of the Superficial Femoral or Proximal Popliteal Artery with placement of a Supera® Stent"
957827|NCT00933270|E2|Reported Event|Supera® Peripheral Stent System Roll-in|"Implantation of Supera stent using the Supera® Peripheral Stent System.~There were a total of 61 roll-in subjects."
957828|NCT00933270|E1|Reported Event|Supera® Peripheral Stent System ITT|"Implantation of Supera stent using the Supera® Peripheral Stent System.~ITT population consisted of 264 subjects."
957829|NCT00933244|B4|Baseline|Total|Total of all reporting groups
957830|NCT00933244|B3|Baseline|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957865|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957942|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957831|NCT00933244|B2|Baseline|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
957869|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957832|NCT00933244|B1|Baseline|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957833|NCT00933244|P3|Participant Flow|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957834|NCT00933244|P2|Participant Flow|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
957835|NCT00933244|P1|Participant Flow|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957836|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957837|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
957838|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957839|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957840|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
957841|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957842|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957843|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
957866|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
958709|NCT00930761|E2|Reported Event|Music Therapy|
957844|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957845|NCT00933244|O3|Outcome|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957846|NCT00933244|O2|Outcome|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
957847|NCT00933244|O1|Outcome|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957848|NCT00933244|E3|Reported Event|Placebo|"Loading Dose: Placebo gel-caps (yellow) to take daily for 15 days plus placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: Placebo gel-caps (yellow) to take two times a month for 350 days plus placebo gel-caps (white) to take daily for 350 days.~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957849|NCT00933244|E2|Reported Event|Low Dose Vitamin D|"Loading Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 15 days plus placebo gel-caps (yellow) to take daily for 15 days.~Maintenance Dose: 800 International Units vitamin D3 gel-caps (white) to take daily for 350 days plus placebo gel-caps (yellow) to take two times a month for 350 days.~Low Dose Vitamin D3: White gel-cap vitamin D3 at 800 International Units to take orally, daily for 355 days~Placebo: Yellow gel-cap placebo pills to take orally, daily for 15 days then two times a month for 350 days."
957850|NCT00933244|E1|Reported Event|High Dose Vitamin D|"Loading Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take daily for 15 days and placebo gel-caps (white) to take daily for 15 days.~Maintenance Dose: 50,000 International Units vitamin D3 gel-caps (yellow) to take two times a month for 350 days and placebo gel-caps (white) to take daily for 350 days.~High Dose Vitamin D3: Yellow gel-cap vitamin D3 at 50,000 International Units to take orally, daily for 15 days then two times a month for 350 days.~Placebo: White gel-cap placebo pills to take orally, daily for 355 days."
957851|NCT00933166|B1|Baseline|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
957852|NCT00933166|P1|Participant Flow|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
957853|NCT00933166|O1|Outcome|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
957854|NCT00933166|E1|Reported Event|Lotrafilcon A|Investigational contact lens worn in both eyes for three months
957855|NCT00932893|B3|Baseline|Total|Total of all reporting groups
957856|NCT00932893|B2|Baseline|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957857|NCT00932893|B1|Baseline|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957858|NCT00932893|P2|Participant Flow|Chemotherapy|Pemetrexed 500 mg per square meter (mg/m^2) intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957859|NCT00932893|P1|Participant Flow|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957860|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957861|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957862|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957863|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957864|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957928|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957867|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957868|NCT00932893|O1|Outcome|Overall Values|Overall assessment for complete response, partial response, stable disease, progressive disease and early death
957946|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
957870|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957871|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957872|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957873|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957874|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957875|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957876|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957877|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957878|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957879|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957880|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957881|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957882|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957883|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957884|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957885|NCT00932893|O2|Outcome|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957886|NCT00932893|O1|Outcome|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957887|NCT00932893|E2|Reported Event|Chemotherapy|Pemetrexed 500 mg/m^2 intravenous infusion over 10 minutes or docetaxel 75 mg/m^2 intravenous infusion over 1 hour on Day 1 of 21-day cycle, as per investigator discretion. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957888|NCT00932893|E1|Reported Event|Crizotinib|Crizotinib (PF-02341066) 250 mg (administered as two 100-mg tablets and one 50-mg tablet) orally twice daily continuously in 21-day cycles. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent occurred.
957889|NCT00932659|B1|Baseline|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
957929|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957930|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957931|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957890|NCT00932659|P1|Participant Flow|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
957947|NCT00932646|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957948|NCT00932646|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
961714|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
957891|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
957892|NCT00932659|O1|Outcome|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
957893|NCT00932659|E1|Reported Event|Single Arm: Hemodialysis Patients Implanted With REVEAL Device|"adult hemodialysis patients without a prior history of cardiac arrhythmias~continuous cardiac monitoring device (REVEAL, Medtronic) : hemodialysis patients without a prior history of cardiac arrhythmias will undergo implantation of a continuous cardiac monitoring device, and will undergo 6 months of follow-up"
957894|NCT00932646|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
957895|NCT00932646|P4|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
957896|NCT00932646|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
957897|NCT00932646|P2|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5mcg qd in the first period, Foradil 12 mcg bid in the second period, placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
957898|NCT00932646|P1|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
957899|NCT00932646|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957900|NCT00932646|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957901|NCT00932646|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957902|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957903|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957904|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957905|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957906|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
957907|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957908|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957909|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957910|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957911|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957912|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957913|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957914|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957915|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957916|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957917|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957918|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957919|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957920|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957921|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957922|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957923|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957924|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957925|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957926|NCT00932646|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
957927|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957943|NCT00932646|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
957944|NCT00932646|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
957945|NCT00932646|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
957952|NCT00932620|B2|Baseline|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
957953|NCT00932620|B1|Baseline|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
957954|NCT00932620|P2|Participant Flow|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
957955|NCT00932620|P1|Participant Flow|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
957956|NCT00932620|O2|Outcome|Simvastatin/Ezetimibe 10/10|
957957|NCT00932620|O1|Outcome|Simvastatin 40|
957958|NCT00932620|O2|Outcome|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
957959|NCT00932620|O1|Outcome|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
957960|NCT00932620|E2|Reported Event|Simvastatin 10 mg Plus Ezetimibe 10 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin/ezetimibe 10/10 mg (n=50) daily
957961|NCT00932620|E1|Reported Event|Simvastatin 40 mg|All subjects will receive dietary instructions according to NCEP-ATP III by a clinical nutritionist. If LDL-C is still above recommended levels after 3 months of appropriate lifestyle changes, patients will be randomly allocated to open-label simvastatin 40 mg daily
957962|NCT00932477|B1|Baseline|All Study Participants|All Study Participants
957963|NCT00932477|P6|Participant Flow|Sequence CBA|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1
957964|NCT00932477|P5|Participant Flow|Sequence CAB|Started with Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2
957965|NCT00932477|P4|Participant Flow|Sequence BCA|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment A: Artificial Tear Formulation 1
957966|NCT00932477|P3|Participant Flow|Sequence BAC|Started with Treatment B: Artificial Tear Formulation 2 followed by Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
957967|NCT00932477|P2|Participant Flow|Sequence ACB|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear followed by Treatment B: Artificial Tear Formulation 2
957968|NCT00932477|P1|Participant Flow|Sequence ABC|Started with Treatment A: Artificial Tear Formulation 1 followed by Treatment B: Artificial Tear Formulation 2 followed by Treatment C: Glycerin and Polysorbate 80 based artificial tear
957969|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
957970|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957971|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957972|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
957973|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957974|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957975|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
957976|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957977|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957978|NCT00932477|O3|Outcome|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
957979|NCT00932477|O2|Outcome|Artificial Tear Formulation 2|Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957980|NCT00932477|O1|Outcome|Artificial Tear Formulation 1|Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear
957981|NCT00932477|E3|Reported Event|Glycerin and Polysorbate 80 Based Artificial Tear|Glycerin and Polysorbate 80 based artificial tear
957982|NCT00932477|E2|Reported Event|Artificial Tear Formulation 2|Formulation 2 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
957983|NCT00932477|E1|Reported Event|Artificial Tear Formulation 1|Formulation 1 Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80 based artificial tear
957984|NCT00932451|B1|Baseline|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958014|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
958207|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
957985|NCT00932451|P1|Participant Flow|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957986|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957987|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957988|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957989|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957990|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957991|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957992|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957993|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957994|NCT00932451|O2|Outcome|Crizotinib 250 mg BID-ALT Controls|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957995|NCT00932451|O1|Outcome|Crizotinib 250 mg BID-ALT Cases|Participants were administered crizotinib at a starting dose of 250 milligram [mg] orally, twice daily (BID) on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957996|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957997|NCT00932451|O2|Outcome|PF-06260182|PF-06260182 was a PF-02341066 metabolite measured in this study.
957998|NCT00932451|O1|Outcome|Crizotinib (PF-02341066)|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
957999|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958000|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958001|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958002|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958003|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958004|NCT00932451|O1|Outcome|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958005|NCT00932451|E1|Reported Event|Crizotinib 250 mg BID|Participants were administered crizotinib at a starting dose of 250 mg orally, BID on a continuous dosing period as two 100-mg tablets and one 50-mg tablet at approximately 12 hours apart the same time each day.
958006|NCT00932425|B3|Baseline|Total|Total of all reporting groups
958007|NCT00932425|B2|Baseline|Control|Patients discharged home with standard clinical follow-up
958008|NCT00932425|B1|Baseline|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958009|NCT00932425|P2|Participant Flow|Control|Patients discharged home with standard clinical follow-up
958054|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958710|NCT00930761|E1|Reported Event|Control|
958010|NCT00932425|P1|Participant Flow|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958011|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958012|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
958013|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958015|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958016|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
958017|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958018|NCT00932425|O2|Outcome|Control|Patients discharged home with standard clinical follow-up
958019|NCT00932425|O1|Outcome|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958020|NCT00932425|E2|Reported Event|Control|Patients discharged home with standard clinical follow-up
958021|NCT00932425|E1|Reported Event|Outpatient Cardiac Monitoring|"Patients assigned to wear a portable outpatient cardiac telemetry device for 21 days~Cardionet Mobile Cardiac Outpatient Telemetry (MCOT): Patients will be assigned to wear the telemetry device for 21 days"
958022|NCT00932399|B3|Baseline|Total|Total of all reporting groups
958023|NCT00932399|B2|Baseline|Group 2|No history of lower limb amputation
958024|NCT00932399|B1|Baseline|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
958025|NCT00932399|P2|Participant Flow|Group 2|No history of lower limb amputation
958026|NCT00932399|P1|Participant Flow|Group 1|Underwent a procedure at a VA medical facility in Veterans Integrated Service Network #20 for a lower limb amputation between 1997 and 2008
958027|NCT00932399|O2|Outcome|Group 2|No history of lower limb amputation
958028|NCT00932399|O1|Outcome|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
958029|NCT00932399|E2|Reported Event|Group 2|No history of lower limb amputation
958030|NCT00932399|E1|Reported Event|Group 1|Underwent a procedure at a VA medical facility in VISN 20 for a lower limb amputation between 1997 and 2008
958031|NCT00932373|B12|Baseline|Total|Total of all reporting groups
958032|NCT00932373|B11|Baseline|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958033|NCT00932373|B10|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958034|NCT00932373|B9|Baseline|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958035|NCT00932373|B8|Baseline|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958036|NCT00932373|B7|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958037|NCT00932373|B6|Baseline|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958038|NCT00932373|B5|Baseline|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958039|NCT00932373|B4|Baseline|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958040|NCT00932373|B3|Baseline|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958041|NCT00932373|B2|Baseline|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958042|NCT00932373|B1|Baseline|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958043|NCT00932373|P11|Participant Flow|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958044|NCT00932373|P10|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958045|NCT00932373|P9|Participant Flow|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958046|NCT00932373|P8|Participant Flow|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958047|NCT00932373|P7|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958048|NCT00932373|P6|Participant Flow|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958049|NCT00932373|P5|Participant Flow|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958050|NCT00932373|P4|Participant Flow|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958051|NCT00932373|P3|Participant Flow|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958052|NCT00932373|P2|Participant Flow|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958053|NCT00932373|P1|Participant Flow|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958055|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958056|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958057|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958058|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958059|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958060|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
961715|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
958061|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958062|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958063|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958064|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958065|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958066|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958067|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958068|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958069|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958070|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958071|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958072|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958073|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958074|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958075|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958076|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958077|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958078|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958079|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958080|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958081|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958082|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958083|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958084|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958085|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958086|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958087|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
958088|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958089|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958090|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958091|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958092|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958093|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958094|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958095|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958096|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958097|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958098|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958099|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958100|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 Every Weeks|Trastuzumab-MCC-DM1 1.2 to 2.9 mg/kg administered intravenously (IV) once every week
958101|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 to 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958102|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958103|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958104|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958105|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958106|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958107|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958108|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958109|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958110|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958111|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958112|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958113|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958114|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958115|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958116|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958117|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958118|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958119|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958120|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958121|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958122|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958123|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958124|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958125|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958126|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958127|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958128|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958129|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958130|NCT00932373|O11|Outcome|Trastuzumab-MCC-DM1 2.9 mg/kg Weekly|Trastuzumab-MCC-DM1 2.9 mg/kg administered intravenously (IV) once a week
958131|NCT00932373|O10|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Weekly|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once a week
958132|NCT00932373|O9|Outcome|Trastuzumab-MCC-DM1 2.0 mg/kg Weekly|Trastuzumab-MCC-DM1 2.0 mg/kg administered intravenously (IV) once a week
958133|NCT00932373|O8|Outcome|Trastuzumab-MCC-DM1 1.6 mg/kg Weekly|Trastuzumab-MCC-DM1 1.6 mg/kg administered intravenously (IV) once a week
958134|NCT00932373|O7|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Weekly|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once a week
958135|NCT00932373|O6|Outcome|Trastuzumab-MCC-DM1 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958136|NCT00932373|O5|Outcome|Trastuzumab-MCC-DM1 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958137|NCT00932373|O4|Outcome|Trastuzumab-MCC-DM1 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958138|NCT00932373|O3|Outcome|Trastuzumab-MCC-DM1 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958139|NCT00932373|O2|Outcome|Trastuzumab-MCC-DM1 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958140|NCT00932373|O1|Outcome|Trastuzumab-MCC-DM1 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM1 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958141|NCT00932373|E11|Reported Event|Trastuzumab-MCC-DM 2.9 mg/kg Weekly|2.9 mg/kg administered intravenously (IV) once a week
958142|NCT00932373|E10|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Weekly|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once a week
958143|NCT00932373|E9|Reported Event|Trastuzumab-MCC-DM 2.0 mg/kg Weekly|Trastuzumab-MCC-DM 2.0 mg/kg administered intravenously (IV) once a week
958144|NCT00932373|E8|Reported Event|Trastuzumab-MCC-DM 1.6 mg/kg Weekly|Trastuzumab-MCC-DM 1.6 mg/kg administered intravenously (IV) once a week
958145|NCT00932373|E7|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Weekly|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once a week
958146|NCT00932373|E6|Reported Event|Trastuzumab-MCC-DM 4.8 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 4.8 mg/kg administered intravenously (IV) once every 3 weeks
958147|NCT00932373|E5|Reported Event|Trastuzumab-MCC-DM 3.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 3.6 mg/kg administered intravenously (IV) once every 3 weeks
958148|NCT00932373|E4|Reported Event|Trastuzumab-MCC-DM 2.4 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 2.4 mg/kg administered intravenously (IV) once every 3 weeks
958149|NCT00932373|E3|Reported Event|Trastuzumab-MCC-DM 1.2 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 1.2 mg/kg administered intravenously (IV) once every 3 weeks
958150|NCT00932373|E2|Reported Event|Trastuzumab-MCC-DM 0.6 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.6 mg/kg administered intravenously (IV) once every 3 weeks
958151|NCT00932373|E1|Reported Event|Trastuzumab-MCC-DM 0.3 mg/kg Every 3 Weeks|Trastuzumab-MCC-DM 0.3 mg/kg administered intravenously (IV) once every 3 weeks
958152|NCT00932321|B3|Baseline|Total|Total of all reporting groups
958153|NCT00932321|B2|Baseline|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
958154|NCT00932321|B1|Baseline|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
958155|NCT00932321|P2|Participant Flow|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
958156|NCT00932321|P1|Participant Flow|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
958157|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
958158|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
958159|NCT00932321|O2|Outcome|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
958160|NCT00932321|O1|Outcome|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
958161|NCT00932321|E2|Reported Event|21 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 21 days followed by 7 placebo tablets
958162|NCT00932321|E1|Reported Event|24 Day NA/EE|Norethindrone acetate/ethinyl estradiol 1 tablet daily for 24 days followed by 4 placebo tablets
958163|NCT00932165|B1|Baseline|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958164|NCT00932165|P1|Participant Flow|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958165|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958166|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958167|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958168|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958169|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
958170|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958171|NCT00932165|O1|Outcome|Exemestane|All the patients whom an investigator prescribes the first Exemestane(Aromasin) should be registered.
958172|NCT00932165|O1|Outcome|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958173|NCT00932165|E1|Reported Event|Exemestane|Exemestane(Aromasin) as prescribed by subject's physician
958174|NCT00932152|B3|Baseline|Total|Total of all reporting groups
958175|NCT00932152|B2|Baseline|Fulvestrant, Anastrozole and Bevacizumab|
958176|NCT00932152|B1|Baseline|Fulvestrant and Anastrozole Only|
958177|NCT00932152|P2|Participant Flow|Fulvestrant, Anastrozole and Bevacizumab|
958178|NCT00932152|P1|Participant Flow|Fulvestrant and Anastrozole Only|
958179|NCT00932152|O1|Outcome|All Participants (Overall Study)|
958180|NCT00932152|E1|Reported Event|All Participants (Overall Study)|
958181|NCT00932126|B1|Baseline|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID and 60 mg BID
958182|NCT00932126|P8|Participant Flow|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice dailly
958183|NCT00932126|P7|Participant Flow|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
958184|NCT00932126|P6|Participant Flow|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
958185|NCT00932126|P5|Participant Flow|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
958186|NCT00932126|P4|Participant Flow|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
958187|NCT00932126|P3|Participant Flow|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
958188|NCT00932126|P2|Participant Flow|PF-03758309, 1 mg Twice Daily (BID)|PF-03758309 1 mg administered orally twice daily
958189|NCT00932126|P1|Participant Flow|PF-03758309, 1 Milligram (mg) Once Daily (QD)|PF-03758309 1 mg administered orally once daily
958190|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958191|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958192|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958193|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958194|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958195|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958196|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958197|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958198|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958352|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958199|NCT00932126|O1|Outcome|PF-03758309|Participants who received: 1 mg QD, 1 mg BID, 2 mg BID, 10 mg BID, 20 mg BID, 40 mg BID, 50 mg BID, and 60 mg BID
958200|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
958201|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
958202|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
958203|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
958204|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309, 10 mg BID PF-03758309 10 mg administered orally twice daily
958205|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
958208|NCT00932126|O8|Outcome|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
958209|NCT00932126|O7|Outcome|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
958210|NCT00932126|O6|Outcome|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
958211|NCT00932126|O5|Outcome|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
958212|NCT00932126|O4|Outcome|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
958213|NCT00932126|O3|Outcome|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
958214|NCT00932126|O2|Outcome|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
958215|NCT00932126|O1|Outcome|PF-03758309, 1 mg QD|PF-03758309 1 mg administered orally once daily
958216|NCT00932126|E8|Reported Event|PF-03758309, 60 mg BID|PF-03758309 60 mg administered orally twice daily
958217|NCT00932126|E7|Reported Event|PF-03758309, 50 mg BID|PF-03758309 50 mg administered orally twice daily
958218|NCT00932126|E6|Reported Event|PF-03758309, 40 mg BID|PF-03758309 40 mg administered orally twice daily
958219|NCT00932126|E5|Reported Event|PF-03758309, 20 mg BID|PF-03758309 20 mg administered orally twice daily
958220|NCT00932126|E4|Reported Event|PF-03758309, 10 mg BID|PF-03758309 10 mg administered orally twice daily
958221|NCT00932126|E3|Reported Event|PF-03758309, 2 mg BID|PF-03758309 2 mg administered orally twice daily
958222|NCT00932126|E2|Reported Event|PF-03758309, 1 mg BID|PF-03758309 1 mg administered orally twice daily
958223|NCT00932126|E1|Reported Event|PF-03758309, 1 mg QD|PF-03758309, 1 mg administered orally once daily
958224|NCT00932035|B3|Baseline|Total|Total of all reporting groups
958225|NCT00932035|B2|Baseline|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
958226|NCT00932035|B1|Baseline|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
958227|NCT00932035|P2|Participant Flow|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
958228|NCT00932035|P1|Participant Flow|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
958229|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
958230|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
958231|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
958232|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
958233|NCT00932035|O2|Outcome|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
958234|NCT00932035|O1|Outcome|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies"
958235|NCT00932035|E2|Reported Event|Arm II (Control)|"Patients undergo standard axillary lymph node dissection and then receive isosulfan blue dye SC.~isosulfan blue based lymphatic mapping~axillary lymph node dissection: Undergo standard axillary lymph node dissection~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
958353|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958236|NCT00932035|E1|Reported Event|Arm I (Reverse Mapping Guided Axillary Lymph Node Dissection)|"Patients receive isosulfan blue dye SC and then undergo reverse mapping-guided axillary lymph node dissection.~axillary lymph node dissection: Undergo reverse mapping-guided axillary lymph node dissection~isosulfan blue based lymphatic mapping~quality-of-life assessment: Ancillary studies~Questionnaire administration: Ancillary studies"
958237|NCT00932022|B3|Baseline|Total|Total of all reporting groups
958238|NCT00932022|B2|Baseline|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958239|NCT00932022|B1|Baseline|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958240|NCT00932022|P2|Participant Flow|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958241|NCT00932022|P1|Participant Flow|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958242|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958243|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958244|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958245|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958246|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958247|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958248|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958249|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958250|NCT00932022|O2|Outcome|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958251|NCT00932022|O1|Outcome|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958252|NCT00932022|E2|Reported Event|Placebo|Placebo capsule taken orally once daily for 14 weeks.
958253|NCT00932022|E1|Reported Event|Trospium Chloride XR 60 mg|Placebo capsule taken orally once daily for 2 weeks followed by trospium chloride extended release (XR) 60 mg capsule taken orally once daily for 12 weeks.
958254|NCT00931996|B1|Baseline|Antipsychotic|Antipsychotic treatment
958255|NCT00931996|P1|Participant Flow|Antipsychotic|Antipsychotic treatment
958256|NCT00931996|O1|Outcome|Antipsychotic|Antipsychotic treatment
958257|NCT00931996|E1|Reported Event|Antipsychotic|Antipsychotic treatment
958258|NCT00931918|B3|Baseline|Total|Total of all reporting groups
958259|NCT00931918|B2|Baseline|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958260|NCT00931918|B1|Baseline|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958261|NCT00931918|P2|Participant Flow|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958262|NCT00931918|P1|Participant Flow|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958263|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958264|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958265|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958354|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958355|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958365|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958266|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958267|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958371|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958372|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958268|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958269|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958270|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958271|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958272|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958273|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958274|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958275|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958276|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958277|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958278|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958279|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958280|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958356|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958357|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958358|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958281|NCT00931918|O2|Outcome|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958282|NCT00931918|O1|Outcome|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958283|NCT00931918|E2|Reported Event|Vc-RCHOP|Vc-RCHOP [bortezomib (VELCADE®), rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: bortezomib (VELCADE ®) 1.3 mg/m^2 administered intravenous (IV) push on Days 1 and 4 of each cycle with RCHOP administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958284|NCT00931918|E1|Reported Event|RCHOP|RCHOP [rituximab, cyclophosphamide, doxorubicin, prednisone] administered as follows: rituximab 375 mg/m^2 intravenous (IV) infusion, cyclophosphamide 750 mg/m^2 IV infusion, doxorubicin 50 mg/m^2 IV injection and vincristine 1.4 mg/m^2 (maximum total dose 2 mg) IV injection on Day 1 with prednisone orally on Days 1 through 5 of a 21-day (3-week) cycle for 6 cycles.
958285|NCT00931879|B3|Baseline|Total|Total of all reporting groups
958286|NCT00931879|B2|Baseline|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958287|NCT00931879|B1|Baseline|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958288|NCT00931879|P2|Participant Flow|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958289|NCT00931879|P1|Participant Flow|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958290|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958291|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958292|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958293|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958294|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958359|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958360|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958295|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958373|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958374|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958375|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958296|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958297|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958298|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958299|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958300|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958301|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958302|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958303|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958304|NCT00931879|O2|Outcome|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958305|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958306|NCT00931879|O2|Outcome|Omega-3-ethyl Esters 4g|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958361|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958362|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958363|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958364|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958307|NCT00931879|O1|Outcome|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958308|NCT00931879|E2|Reported Event|Lovaza|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.~omega-3-acie ethyl esters: Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients."
958309|NCT00931879|E1|Reported Event|Placebo|"Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.~Placebo: Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months."
958310|NCT00931801|B4|Baseline|Total|Total of all reporting groups
958311|NCT00931801|B3|Baseline|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
958312|NCT00931801|B2|Baseline|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
958313|NCT00931801|B1|Baseline|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
958314|NCT00931801|P3|Participant Flow|Intervention Arm No.2|atazanavir/raltegravir: switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
958315|NCT00931801|P2|Participant Flow|Intervention Arm No.1|atazanavir/raltegravir: switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
958316|NCT00931801|P1|Participant Flow|Control Arm|atazanavir/tenofovir/emtricitabine : Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
958317|NCT00931801|O4|Outcome|Total|All study arms combined
958318|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
958319|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
958320|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
958321|NCT00931801|O4|Outcome|Total|All study arms combined
958322|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
958323|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
958324|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
958325|NCT00931801|O4|Outcome|Total|All study arms combined
958326|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
958327|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
958328|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
958329|NCT00931801|O3|Outcome|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
958330|NCT00931801|O2|Outcome|Intervention Arm No.1|switch to atazanavir/ritonavir 300/100mg once daily plus raltegravir 400mg twice daily
958331|NCT00931801|O1|Outcome|Control Arm|Continue baseline regimen of atazanavir/ritonavir 300/100mg once daily plus tenofovir and emtricitabine
958332|NCT00931801|E4|Reported Event|Total|All study arms combined
958333|NCT00931801|E3|Reported Event|Intervention Arm No.2|switch to atazanavir 300mg twice daily plus raltegravir 400mg twice daily
958334|NCT00931801|E2|Reported Event|Intervention Arm No.1|switch to atazanavir/r 300/100mg once daily plus raltegravir 400mg twice daily
958335|NCT00931801|E1|Reported Event|Control Arm|Continue baseline regimen of atazanavir/r 300/100mg once daily plus tenofovir and emtricitabine
958336|NCT00931723|B3|Baseline|Total|Total of all reporting groups
958337|NCT00931723|B2|Baseline|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958338|NCT00931723|B1|Baseline|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958339|NCT00931723|P2|Participant Flow|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958340|NCT00931723|P1|Participant Flow|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958341|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958342|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958343|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958344|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958345|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958346|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958347|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958348|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958349|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958350|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958351|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958366|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958367|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958368|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958369|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958370|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958376|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958377|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958378|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958379|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958380|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958381|NCT00931723|O2|Outcome|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958382|NCT00931723|O1|Outcome|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958383|NCT00931723|E2|Reported Event|Placebo+Quetiapine XR|Placebo+quetiapine XR 400 to 800 mg/day
958384|NCT00931723|E1|Reported Event|Lithium+Quetiapine XR|Lithium 600 to 1800 mg/day+quetiapine XR 400 to 800 mg/day
958385|NCT00931710|B3|Baseline|Total|Total of all reporting groups
958386|NCT00931710|B2|Baseline|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958387|NCT00931710|B1|Baseline|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958388|NCT00931710|P2|Participant Flow|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958389|NCT00931710|P1|Participant Flow|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958390|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958391|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958392|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958393|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958394|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958395|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958396|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958497|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958882|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
958397|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958398|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958437|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
958508|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958399|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958400|NCT00931710|O2|Outcome|Losartan/HCTZ|Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force-titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
958401|NCT00931710|O1|Outcome|Valsartan/Amlodipine/HCTZ|Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
958402|NCT00931710|E2|Reported Event|Losartan / HCTZ|Losartan / HCTZ
958403|NCT00931710|E1|Reported Event|Valsartan / Amlodipine / HCTZ|Valsartan / amlodipine / HCTZ
958404|NCT00931632|B3|Baseline|Total|Total of all reporting groups
958405|NCT00931632|B2|Baseline|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
958406|NCT00931632|B1|Baseline|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
958407|NCT00931632|P2|Participant Flow|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
958408|NCT00931632|P1|Participant Flow|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
958409|NCT00931632|O2|Outcome|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
958410|NCT00931632|O1|Outcome|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
958411|NCT00931632|E2|Reported Event|Placebo|"Nitrogen Placebo~Placebo: Nitrogen gas will be administered in the same manner as the experimental drug."
958412|NCT00931632|E1|Reported Event|Inhaled Nitric Oxide|"Inhaled Nitric Oxide~Inhaled Nitric Oxide: Inhaled Nitric Oxide will be administered continuously starting at 20ppm into the inspiratory limb of the ventilator circuit in mechanically ventilated subject using an INOvent delivery system of by nasal cannula as needed for 24 days of therapy."
958413|NCT00931528|B3|Baseline|Total|Total of all reporting groups
958414|NCT00931528|B2|Baseline|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
958415|NCT00931528|B1|Baseline|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
958416|NCT00931528|P2|Participant Flow|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
958417|NCT00931528|P1|Participant Flow|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
958418|NCT00931528|O2|Outcome|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
958419|NCT00931528|O1|Outcome|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil once daily for 24 weeks.
958420|NCT00931528|E2|Reported Event|Placebo|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral placebo once daily for 24 weeks.
958421|NCT00931528|E1|Reported Event|Tadalafil|Beginning ≤ 7 days after the start of radiotherapy, patients receive oral tadalafil 5mg once daily for 24 weeks.
958422|NCT00931515|B3|Baseline|Total|Total of all reporting groups
958423|NCT00931515|B2|Baseline|ProDisc|The ProDisc® total disc replacement system.
958424|NCT00931515|B1|Baseline|NuBac|The NUBAC® disc arthroplasty system.
958425|NCT00931515|P2|Participant Flow|ProDisc|The ProDisc® total disc replacement system.
958426|NCT00931515|P1|Participant Flow|NuBac|The NUBAC® disc arthroplasty system.
958427|NCT00931515|O2|Outcome|ProDisc|The ProDisc® device total disc replacement system.
958428|NCT00931515|O1|Outcome|NuBac|The NUBAC® disc arthroplasty system.
958429|NCT00931515|E2|Reported Event|ProDisc|The ProDisc® device total disc replacement system.
958430|NCT00931515|E1|Reported Event|NuBac|The NUBAC® disc arthroplasty system.
958431|NCT00931463|B3|Baseline|Total|Total of all reporting groups
958432|NCT00931463|B2|Baseline|Ritonavir-boosted Lopinavir and Raltegravir|Lopinavir /ritonavir + raltegravir: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + raltegravir 400mg 1 tablet twice daily
958433|NCT00931463|B1|Baseline|Ritonavir-boosted Lopinavir and 2N(t)RTI|Lopinavir / ritonavir + 2-3N(t)RTI: LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily + 2-3 N(t)RTI
958498|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958434|NCT00931463|P2|Participant Flow|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
958435|NCT00931463|P1|Participant Flow|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
958436|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
958505|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958438|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
958439|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
958440|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
958441|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
958442|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
958443|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
958444|NCT00931463|O2|Outcome|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
958445|NCT00931463|O1|Outcome|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
958446|NCT00931463|E2|Reported Event|Ritonavir-boosted Lopinavir and Raltegravir|This is an experimental arm which is likely to be fully active in the presence of N(t)RTI mutations and which preliminary evidence suggests should be potent and durable.
958447|NCT00931463|E1|Reported Event|Ritonavir-boosted Lopinavir and 2N(t)RTI|This is the current standard of care for second line therapy following failure of standard first-line NNRTI+2N(t)RTIs according to WHO guidelines.
958448|NCT00931411|B3|Baseline|Total|Total of all reporting groups
958449|NCT00931411|B2|Baseline|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
958450|NCT00931411|B1|Baseline|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
958451|NCT00931411|P2|Participant Flow|Formulation 609209 Then 609580 20|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. THis is followed by the same application of formulation 609580 20 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
958452|NCT00931411|P1|Participant Flow|Formulation 609580 20 Then 609209|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. This is followed by the same application of formulation 609209 for 2 weeks. Dosage is at the discretion of the parent applying the cream to the child.
958453|NCT00931411|O1|Outcome|All Study Patients|
958454|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
958455|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
958456|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958457|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958458|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for the 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
958459|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 14 days after the crossover. Dosage is at the discretion of the parent applying the cream to the child.
958460|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958461|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958462|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958463|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958464|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958465|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958506|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958507|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958466|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958467|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958468|NCT00931411|O2|Outcome|Formulation 609209|Formulation 609209 cream is applied topically to entire body, twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958469|NCT00931411|O1|Outcome|Formulation 609580 20|Formulation 609580 20 cream is applied topically to the entire body twice a day, morning and evening, after bathing for 42 days. Dosage is at the discretion of the parent applying the cream to the child.
958470|NCT00931411|E2|Reported Event|Formulation 609209|"Adverse events that were recorded before Day 42 for the group Formulation 609209 then 609580 20 and recorded in the subsequent 2 weeks for the group Formulation 609580 20 then 609209. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
958471|NCT00931411|E1|Reported Event|Formulation 609580 20|"Adverse events that were recorded before Day 42 for the group Formulation 609580 20 then 609209 and recorded in the subsequent 2 weeks for the group Formulation 609209 then 609580 20. Since this treatment was applied to both groups during this crossover study then the number of patients at risk for each treatment was the total of both groups."
958472|NCT00931385|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, double dummy, placebo- and active-controlled, 4 way crossover trial. 99 patients were assigned randomly to one of 4 treatment sequences in which they received each of 4 treatments, two doses (5 microgram (mcg) or 10 mcg) of Olodaterol (Olo) once daily (qd) delivered via the Respimat inhaler or Foradil (Form) 12 mcg twice daily (bid) delivered via the Aerolizer inhaler or equivalent placebo delivered by Respimat Inhaler or Aerolizer Inhaler. The duration of each treatment period was 6 weeks with a 14 day washout period between treatments.
958473|NCT00931385|P4|Participant Flow|Placebo / Olo 5mcg / Olo 10mcg / Foradil 12mcg|Patients were administered matching Placebo in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Foradil 12 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
958474|NCT00931385|P3|Participant Flow|Olo 10mcg / Placebo / Foradil 12mcg / Olo 5mcg|Patients were administered Olodaterol 10 mcg qd in the first period, matching Placebo in the second period, Foradil 12 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
958475|NCT00931385|P2|Participant Flow|Foradil 12mcg / Olo 10mcg / Olo 5mcg / Placebo|Patients were administered Foradil 12 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and matching Placebo in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
958476|NCT00931385|P1|Participant Flow|Olo 5mcg / Foradil 12mcg / Placebo / Olo 10mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Foradil 12 mcg bid in the second period, matching Placebo in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler, Foradil was administered via the Aerolizer inhaler.
958477|NCT00931385|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958478|NCT00931385|O3|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958479|NCT00931385|O2|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958480|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958481|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958482|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958483|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958484|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958485|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958486|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958487|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958488|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958489|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958490|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958491|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958492|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958493|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958494|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958495|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958496|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
960680|NCT00926536|E2|Reported Event|DSA Only|DSA only used for navigation
958499|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958500|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958501|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958502|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958503|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958504|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958509|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958510|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958511|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958512|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958513|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958514|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958515|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958516|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958517|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958518|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958519|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958520|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958521|NCT00931385|O4|Outcome|Form 12 mcg Bid|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958522|NCT00931385|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958523|NCT00931385|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958524|NCT00931385|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler or Aerolizer Inhaler.
958525|NCT00931385|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
958526|NCT00931385|E3|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
958527|NCT00931385|E2|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
958528|NCT00931385|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
958529|NCT00931359|B3|Baseline|Total|Total of all reporting groups
958530|NCT00931359|B2|Baseline|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
958531|NCT00931359|B1|Baseline|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
958532|NCT00931359|P2|Participant Flow|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
958533|NCT00931359|P1|Participant Flow|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
958534|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
958535|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
958536|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
958537|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
958538|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
958539|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
958540|NCT00931359|O2|Outcome|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
958541|NCT00931359|O1|Outcome|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
958542|NCT00931359|E2|Reported Event|Treatment With DTS-G2 System|Subjects received treatment in one to three treatment sessions with fixed device settings. Settings were at a generator output energy of 220J.
958543|NCT00931359|E1|Reported Event|Sham Treatment|Subjects received a sham treatment in two treatment sessions.
958544|NCT00931307|B1|Baseline|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
958545|NCT00931307|P1|Participant Flow|Lotrafilcon A|Silicone hydrogel, spherical, experimental soft contact lenses worn on the same basis as habitual contact lenses as prescribed by eye care practitioner
958546|NCT00931307|O1|Outcome|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
958547|NCT00931307|E1|Reported Event|Lotrafilcon A|Silicone hydrogel, spherical, soft contact lens
958548|NCT00931268|B1|Baseline|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958549|NCT00931268|P1|Participant Flow|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958584|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958550|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958551|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958552|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958553|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958554|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958555|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
959464|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
958556|NCT00931268|O1|Outcome|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958557|NCT00931268|E1|Reported Event|Macrolane VRF 30|Open label, baseline-controlled, one treatment session with injection of Macrolane VRF30 to each buttock, not exceeding 400 ml per subject.
958558|NCT00931242|B3|Baseline|Total|Total of all reporting groups
958559|NCT00931242|B2|Baseline|Screen Failures|Subjects that were screened but failed to meet inclusion criteria for the study.
958560|NCT00931242|B1|Baseline|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO (by mouth) twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type atopic dermatitis or allergic contact dermatitis.
958561|NCT00931242|P2|Participant Flow|Screen Failures|Patients who were screened but failed to meet inclusion criteria for the study
958562|NCT00931242|P1|Participant Flow|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
958563|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
958564|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
958565|NCT00931242|O1|Outcome|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
958566|NCT00931242|E1|Reported Event|Apremilast|Apremilast is being evaluated at daily doses of 20 mg PO twice daily (BID) for 12 weeks of treatment (treatment phase) in subjects with recalcitrant plaque-type AD or ACD.
958567|NCT00931164|B1|Baseline|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
958568|NCT00931164|P1|Participant Flow|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
958569|NCT00931164|O1|Outcome|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
958570|NCT00931164|E1|Reported Event|Sodium Oxybate|"The study is an open-label, Phase I/II trial designed to obtain additional safety and pharmacokinetic parameters for use of sodium oxybate in children and adolescents afflicted with AHC.~Given the limited number of children carrying the diagnosis of AHC, typical controls will not be available for our study. In lieu of this, the subjective recording of ictal episodes in the 6 week period prior to drug initiation will serve as reference in determining drug efficacy.~Sodium Oxybate : dosage is by weight"
958571|NCT00930982|B3|Baseline|Total|Total of all reporting groups
958572|NCT00930982|B2|Baseline|Placebo|Inhalation of matching placebo twice a day
958573|NCT00930982|B1|Baseline|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958574|NCT00930982|P2|Participant Flow|Placebo|Inhalation of matching placebo twice a day
958575|NCT00930982|P1|Participant Flow|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958576|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958577|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958578|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958579|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958580|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958581|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958582|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958583|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
961324|NCT00924638|B3|Baseline|Total|Total of all reporting groups
958585|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958586|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958587|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958588|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958589|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958590|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958591|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958592|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958593|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958594|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958595|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958596|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958597|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958598|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958599|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958600|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958601|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958602|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958603|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958604|NCT00930982|O2|Outcome|Placebo|Inhalation of matching placebo twice a day
958605|NCT00930982|O1|Outcome|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958606|NCT00930982|E2|Reported Event|Placebo|Inhalation of matching placebo twice a day
958607|NCT00930982|E1|Reported Event|Ciprofloxacin Inhale (BAYQ3939)|32.5 mg ciprofloxacin hydrated corresponding to 50 mg Ciprofloxacin PulmoSphere Inhalation Powder twice daily
958608|NCT00930969|B1|Baseline|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958609|NCT00930969|P1|Participant Flow|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958610|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958611|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958612|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958613|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958614|NCT00930969|O1|Outcome|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958615|NCT00930969|E1|Reported Event|ICD Indicated|Subjects indicated for ICD therapy and at risk for recurrent myocardial infarction.
958616|NCT00930930|B3|Baseline|Total|Total of all reporting groups
958617|NCT00930930|B2|Baseline|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958618|NCT00930930|B1|Baseline|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958619|NCT00930930|P2|Participant Flow|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958620|NCT00930930|P1|Participant Flow|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958621|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958652|NCT00930774|B4|Baseline|Standard-of-Care|Standard-of-care informational counseling
958653|NCT00930774|B3|Baseline|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958622|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958623|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958659|NCT00930774|P1|Participant Flow|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958624|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958625|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958626|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958627|NCT00930930|O2|Outcome|Cisplatin and Paclitaxel + Placebo|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958628|NCT00930930|O1|Outcome|Cisplatin and Paclitaxel + RAD001|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958629|NCT00930930|E2|Reported Event|Arm II|"Cisplatin 25 mg/m2 IV weekly + placebo PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + placebo PO daily for 11 weeks~cisplatin: Given IV~paclitaxel: Given IV~placebo: Given orally~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958630|NCT00930930|E1|Reported Event|Arm I|"Cisplatin 25 mg/m2 IV weekly + RAD001 5 mg PO daily for 1 week followed by Cisplatin 25 mg/m2 IV + Paclitaxel 80 mg/m2 IV weekly + RAD001 5 mg PO daily for 11 weeks~cisplatin: Given IV~everolimus: Given orally~paclitaxel: Given IV~Venous blood draw: Venous blood (2-3 tablespoons) will be taken for germline DNA analysis to complement the correlative studies in the tumor tissue. Blood can be drawn at any time prior, during, or after completion of study treatment"
958631|NCT00930813|B3|Baseline|Total|Total of all reporting groups
958632|NCT00930813|B2|Baseline|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
958633|NCT00930813|B1|Baseline|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
958634|NCT00930813|P2|Participant Flow|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
958635|NCT00930813|P1|Participant Flow|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
958636|NCT00930813|O2|Outcome|Uncoated PTA Balloon Catheter|Standard, uncoated, off-the-shelf PTA Balloon Angioplasty Catheter
958637|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix DCB: Paclitaxel Coated Balloon Catheter
958638|NCT00930813|O2|Outcome|Standard Uncoated PTA Catheter|Standard off-the-shelf uncoated PTA Catheter
958639|NCT00930813|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel Coated Balloon Catheter
958640|NCT00930813|E2|Reported Event|Standard Uncoated Balloon Angioplasty Catheter|"uncoated angioplasty balloon~Standard uncoated Balloon Angioplasty Catheter: plain, uncoated angioplasty balloon catheter"
958641|NCT00930813|E1|Reported Event|Lutonix Catheter|"Paclitaxel coated Balloon Catheter~Lutonix Catheter: Paclitaxel Coated Balloon Catheter"
958642|NCT00930787|B3|Baseline|Total|Total of all reporting groups
958643|NCT00930787|B2|Baseline|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
958644|NCT00930787|B1|Baseline|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
958645|NCT00930787|P2|Participant Flow|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
958646|NCT00930787|P1|Participant Flow|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
958647|NCT00930787|O2|Outcome|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
958648|NCT00930787|O1|Outcome|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
958649|NCT00930787|E2|Reported Event|Proceed Surgical Mesh|Use of Proceed Surgical Mesh to support hernia repair
958650|NCT00930787|E1|Reported Event|Strattice Reconstructive Tissue Matrix|Use of Strattice Reconstructive Tissue Matrix to support hernia repair
958651|NCT00930774|B5|Baseline|Total|Total of all reporting groups
958654|NCT00930774|B2|Baseline|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958655|NCT00930774|B1|Baseline|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958656|NCT00930774|P4|Participant Flow|Standard-of-Care|Standard-of-care informational counseling
958657|NCT00930774|P3|Participant Flow|FM System and Auditory Training|"Provision of frequency modulation (FM) assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958658|NCT00930774|P2|Participant Flow|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958660|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958661|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958662|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958663|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958664|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958665|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958666|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958667|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958668|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958669|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958670|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958671|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958672|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958673|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958674|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958675|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958676|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958677|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958678|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958679|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958680|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958681|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958682|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958683|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958684|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958685|NCT00930774|O3|Outcome|FM Sytem + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958686|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958687|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958688|NCT00930774|O4|Outcome|Standard-of-care|Standard-of-care informational counseling
958689|NCT00930774|O3|Outcome|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958690|NCT00930774|O2|Outcome|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958691|NCT00930774|O1|Outcome|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958692|NCT00930774|E4|Reported Event|Standard-of-care|Standard-of-care informational counseling
958693|NCT00930774|E3|Reported Event|FM System + Auditory Training|"Provision of FM assistive device and auditory training~FM system: Frequency modulation assistive device~Auditory training: Participation in computerized auditory training program for eight weeks"
958694|NCT00930774|E2|Reported Event|Auditory Training|"Provision of auditory training~Auditory training: Participation in computerized auditory training program for eight weeks"
958695|NCT00930774|E1|Reported Event|FM System|"Provision of FM assistive device~FM system: Frequency modulation assistive device"
958696|NCT00930761|B3|Baseline|Total|Total of all reporting groups
958697|NCT00930761|B2|Baseline|Music Therapy|
958711|NCT00930722|B1|Baseline|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958712|NCT00930722|P1|Participant Flow|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958713|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958714|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958715|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958716|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958717|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958718|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958719|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958720|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958721|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958722|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958723|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958724|NCT00930722|O1|Outcome|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958725|NCT00930722|E1|Reported Event|Quinapril|Quinapril, starting at a dose of 10 milligram (mg) up to 80 mg once per day orally in accordance with the locally approved prescribing information, in participants who had already been receiving Quinapril for a minimum duration of 4 weeks.
958726|NCT00930644|B1|Baseline|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
958727|NCT00930644|P1|Participant Flow|Teduglutide 0.05 mg/kg/Day|teduglutide: 0.05 mg/kg/day subcutaneously taken once per day for 24 months
958728|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958729|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958730|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958731|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958732|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958733|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958734|NCT00930644|O3|Outcome|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958735|NCT00930644|O2|Outcome|PBO/TED|Placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958736|NCT00930644|O1|Outcome|NT/TED|No treatment in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958737|NCT00930644|E2|Reported Event|TED/TED|0.05 mg/kg/day subcutaneously taken once per day for 6 months CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958738|NCT00930644|E1|Reported Event|NT,PBO/TED|No treatment or placebo in CL0600-020 trial and teduglutide 0.05 mg/kg/day subcutaneously taken once per day for 24 months in CL0600-021 trial
958767|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958768|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958883|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
958739|NCT00930553|B1|Baseline|Alemtuzumab|Participants enrolled from any of the previous studies received long-term follow-up in this study. Participants randomized to receive IFNB-1a in any of the previous studies received alemtuzumab 12 mg/day infusion IV, QD for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on MRI), unless they met safety-related retreatment disqualifying criteria.
958772|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958890|NCT00929708|B2|Baseline|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958740|NCT00930553|P1|Participant Flow|Alemtuzumab|Participants enrolled from any of the prior studies received long-term follow-up in this study. Participants randomized to receive interferon beta-1a (IFNB-1a) in prior studies received alemtuzumab 12 mg/day infusion intravenously (IV) once daily (QD) for 5 consecutive days in treatment Course 1, and for 3 consecutive days in treatment Course 2, 12 months later in this study. Participants who received 2 treatment courses with alemtuzumab could be treated with additional alemtuzumab courses of 12 mg/day infusion IV QD, for 3 consecutive days at least 48 weeks after the prior course if they had documented evidence of resumed disease activity (defined as >=1 protocol-defined relapse and/or >=2 new or enlarging brain or spinal lesions on magnetic resonance imaging [MRI]), unless they met safety-related retreatment disqualifying criteria.
958741|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958742|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958743|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958744|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958745|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958746|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958747|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958748|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958749|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958750|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958751|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958752|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958753|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958754|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958755|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958756|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958757|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958758|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958759|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958760|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958761|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958762|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958763|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958764|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958765|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958766|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958769|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958770|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958771|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958891|NCT00929708|B1|Baseline|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958773|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
958774|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958775|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958776|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958777|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958778|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958779|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958780|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 or CAMMS324 who received an additional course of alemtuzumab in CAMMS03409.
958781|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958782|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958783|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958784|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958785|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in extension study CAMMS03409.
958786|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in extension study CAMMS03409.
958787|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958788|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958789|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
958790|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
958791|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958792|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958793|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958794|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323 who were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958795|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study.
958796|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study.
958797|NCT00930553|O1|Outcome|Alemtuzumab Retreatment|Participants who received alemtuzumab in CAMMS323 (NCT00530348) or CAMMS324 (NCT00548405), received an additional course of alemtuzumab in this study.
958798|NCT00930553|O4|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958799|NCT00930553|O3|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS324/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS324, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958800|NCT00930553|O2|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Post Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. Alemtuzumab treatment period
958801|NCT00930553|O1|Outcome|IFNB-1a/Alemtuzumab Switch CAMMS323/03409 (Pre Alemtuzumab)|Participants who received IFNB-1a in CAMMS323, were treated with alemtuzumab in CAMMS03409. IFNB-1a treatment period
958802|NCT00930553|O2|Outcome|Alemtuzumab Treatment CAMMS324 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS324 (NCT00548405) and enrolled in this extension study (CAMMS03409).
958803|NCT00930553|O1|Outcome|Alemtuzumab Treatment CAMMS323 Extension|Participants who were randomized to alemtuzumab 12 mg/day treatment in CAMMS323 (NCT00530348) and enrolled in this extension study (CAMMS03409).
958804|NCT00930553|E1|Reported Event|Alemtuzumab|Participants enrolled in any of the previous studies who had received alemtuzumab. Participants enrolled in any of the previous studies who had received IFNB-1a, who received alemtuzumab 12 mg/day infusion in this study.
958805|NCT00930293|B3|Baseline|Total|Total of all reporting groups
958828|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
959465|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
958806|NCT00930293|B2|Baseline|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958807|NCT00930293|B1|Baseline|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958808|NCT00930293|P2|Participant Flow|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958809|NCT00930293|P1|Participant Flow|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958810|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958811|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958812|NCT00930293|O2|Outcome|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958813|NCT00930293|O1|Outcome|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958814|NCT00930293|E2|Reported Event|Standard Depression Care|"Participants will receive brief supportive psychotherapy (BSP) and standard antidepressant medication treatment.~Brief Supportive Psychotherapy (BSP): 16 weekly BPS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958815|NCT00930293|E1|Reported Event|Personalized Depression Care|"Participants will receive interpersonal psychotherapy for depression with panic and anxiety symptoms (IPT-PS) and standard antidepressant medication treatment.~Interpersonal Psychotherapy for Depression with Panic and Anxiety Symptoms (IPT-PS): 16 weekly IPT-PS sessions, each lasting approximately 45 minutes~Citalopram hydrobromide: A 20-week regimen of citalopram hydrobromide monotherapy on a flexible dosing schedule ranging from 10 to 60 mg/day"
958816|NCT00930176|B1|Baseline|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
958817|NCT00930176|P1|Participant Flow|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
958818|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
958819|NCT00930176|O1|Outcome|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
958820|NCT00930176|E1|Reported Event|Human Coagulation FACTOR X|Human Coagulation FACTOR X: Standard dose 25IU/kg to be administered at the Baseline Visit (1st PK assessment) and at the repeat PK assessment. Also administered to treat a bleed or to prevent a bleed.
958821|NCT00929981|B1|Baseline|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958822|NCT00929981|P1|Participant Flow|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958823|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958824|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958881|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
958825|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958826|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958827|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958829|NCT00929981|O1|Outcome|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958830|NCT00929981|E1|Reported Event|Medrol|Medrol tablets 4 milligram (mg) and 16 mg were given orally as per locally approved prescribing information. The duration of therapy was flexible.
958831|NCT00929864|B3|Baseline|Total|Total of all reporting groups
958832|NCT00929864|B2|Baseline|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958833|NCT00929864|B1|Baseline|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958834|NCT00929864|P2|Participant Flow|40 mg Adalimumab SC Biweekly|Adalimumab 40 mg, biweekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958835|NCT00929864|P1|Participant Flow|125 mg Abatacept SC Weekly|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958836|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958837|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958838|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958839|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958840|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958841|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958842|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958843|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
961689|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
958844|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958888|NCT00929708|B4|Baseline|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958889|NCT00929708|B3|Baseline|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958845|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958846|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958847|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958848|NCT00929864|O2|Outcome|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958849|NCT00929864|O1|Outcome|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958850|NCT00929864|E2|Reported Event|Adalimumab|Adalimumab 40 mg, bi-weekly (every 14 days) subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958851|NCT00929864|E1|Reported Event|Abatacept|Abatacept 125 mg weekly subcutaneous (SC) self administered injections for 24 months (729 days). Methotrexate (MTX) was co-administered; a stable dose of maximum tolerated methotrexate (minimum of 15 mg and maximum of 25 mg) per week. Participants were allowed to enroll with MTX doses <15 mg/week but >= 7.5 mg/week if intolerance to higher doses was documented. Participants could also enroll while receiving hydrochloroquine or sulfasalazine in addition to MTX.
958852|NCT00929773|B3|Baseline|Total|Total of all reporting groups
958853|NCT00929773|B2|Baseline|Placebo Laser|inactive light
958854|NCT00929773|B1|Baseline|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
958855|NCT00929773|P2|Participant Flow|Placebo Laser|inactive light
958856|NCT00929773|P1|Participant Flow|Erchonia PL2000 Laser|Low level laser energy comprised of 1 milliWatt (mW) of near-infrared light (635 nm) to the neck and shoulder area .
958857|NCT00929773|O2|Outcome|Placebo Laser|inactive light
958858|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
958859|NCT00929773|O2|Outcome|Placebo Laser|inactive light
958860|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
958861|NCT00929773|O2|Outcome|Placebo Laser|inactive light
958862|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
958863|NCT00929773|O2|Outcome|Placebo Laser|inactive light
958864|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
958865|NCT00929773|O2|Outcome|Placebo Laser|inactive light
958866|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area.
958867|NCT00929773|O2|Outcome|Placebo Laser|inactive light
958868|NCT00929773|O1|Outcome|Erchonia PL2000 Laser|Low level laser energy comprised of 1 mW of near-infrared light (635 nm) to the neck and shoulder area .
958869|NCT00929773|E2|Reported Event|Placebo Laser|inactive light
958870|NCT00929773|E1|Reported Event|Erchonia Low Level Laser Therapy|Low level laser energy comprised of 1 mw of near-infrared light (635 nm) to the neck and shoulder area .
958871|NCT00929734|B3|Baseline|Total|Total of all reporting groups
958872|NCT00929734|B2|Baseline|Placebo|Placebo tablet
958873|NCT00929734|B1|Baseline|Rosuvastatin|Rosuvastatin 10mg tablet
958874|NCT00929734|P2|Participant Flow|Placebo|Placebo: 1 tablet, once daily in three months
958875|NCT00929734|P1|Participant Flow|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
958876|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
958877|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
958878|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
958879|NCT00929734|O1|Outcome|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
958880|NCT00929734|O2|Outcome|Placebo|Placebo: 1 tablet, once daily in three months
958884|NCT00929734|E2|Reported Event|Placebo|Placebo: 1 tablet, once daily in three months
958885|NCT00929734|E1|Reported Event|Rosuvastatin|Rosuvastatin: 10mg tablets, once daily in three months
958886|NCT00929708|B6|Baseline|Total|Total of all reporting groups
958887|NCT00929708|B5|Baseline|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
961716|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
958892|NCT00929708|P5|Participant Flow|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958893|NCT00929708|P4|Participant Flow|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958894|NCT00929708|P3|Participant Flow|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958895|NCT00929708|P2|Participant Flow|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958896|NCT00929708|P1|Participant Flow|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958897|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958898|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958899|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958900|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958901|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958902|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958903|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958904|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958905|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958906|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958907|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958908|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958909|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958910|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958911|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958912|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958913|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958914|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958915|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958916|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958917|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958918|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958919|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958920|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958921|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958922|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958923|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958924|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958925|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958926|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958927|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958928|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958929|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958930|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958931|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958932|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958933|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958934|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958935|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958936|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958937|NCT00929708|O5|Outcome|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958938|NCT00929708|O4|Outcome|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958939|NCT00929708|O3|Outcome|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
958940|NCT00929708|O2|Outcome|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958941|NCT00929708|O1|Outcome|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958942|NCT00929708|E5|Reported Event|Placebo|2 x placebo Turbuhaler (morning) + 2 x placebo Turbuhaler (evening)
958943|NCT00929708|E4|Reported Event|Formoterol 9 Mcg Bid|2 x Oxis Turbuhaler 4.5 mcg (morning) + 2 x Oxis Turbuhaler 4.5 mcg (evening)
958944|NCT00929708|E3|Reported Event|AZD3199 800 Mcg od|2 x AZD3199 Turbuhaler 400 mcg (morning) + 2 x placebo Turbuhaler (evening)
961717|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
958945|NCT00929708|E2|Reported Event|AZD3199 400 Mcg od|2 x AZD3199 Turbuhaler 200 mcg (morning) + 2 x placebo Turbuhaler (evening)
958946|NCT00929708|E1|Reported Event|AZD3199 200 Mcg od|2 x AZD3199 Turbuhaler 100 mcg (morning) + 2 x placebo Turbuhaler (evening)
958947|NCT00929695|B3|Baseline|Total|Total of all reporting groups
958948|NCT00929695|B2|Baseline|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958949|NCT00929695|B1|Baseline|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958950|NCT00929695|P2|Participant Flow|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958951|NCT00929695|P1|Participant Flow|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958952|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958953|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958954|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958955|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958956|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958957|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958958|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958959|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958960|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958961|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958962|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958963|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958964|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958965|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958966|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958967|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958968|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958969|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958970|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone
958993|NCT00929578|O1|Outcome|Baseline|Number of participants with fluphenazine serum levels > 0.200ng/ml at baseline
958971|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958972|NCT00929695|O2|Outcome|Group B (Standard-dose)|Patients received prednisone-equivalent standard doses of prednisone depending on presenting grade of acute GVHD (1.0 mg/kg/day for mild GVHD or 2.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958973|NCT00929695|O1|Outcome|Group A (Low-dose)|Patients received prednisone-equivalent low doses of prednisone depending on presenting grade of acute GVHD (0.5 mg/kg/day for mild GVHD or 1.0 mg/kg/day for moderate/severe GVHD). Patients could receive prednisone or methylprednisolone.
958974|NCT00929695|O4|Outcome|Grade IIb-IV GVHD; 2.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 2.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
958975|NCT00929695|O3|Outcome|Grade IIb-IV GVHD; 1.0 mg/kg/d Prednisone|Patients with moderate/severe acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
958976|NCT00929695|O2|Outcome|Grade IIa GVHD; 1.0 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 1.0 mg/kg/day (standard dose). Patients could be treated with prednisone or methylprednisolone.
958977|NCT00929695|O1|Outcome|Grade IIa GVHD; 0.5 mg/kg/d Prednisone|Patients with mild acute GVHD were treated with a prednisone-equilavent dose of 0.5 mg/kg/day (low dose). Patients could be treated with prednisone or methylprednisolone.
958978|NCT00929695|E2|Reported Event|Arm II (Standard-dose)|"Patients receive standard-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
958979|NCT00929695|E1|Reported Event|Arm I (Low-dose)|"Patients receive low-dose prednisone or methylprednisolone once or twice daily in the absence of disease progression or unacceptable toxicity.~prednisone: immunosuppressive drug~methylprednisolone: immunosuppressive drug~questionnaire administration: Ancillary studies"
958980|NCT00929643|B1|Baseline|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958981|NCT00929643|P1|Participant Flow|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958982|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958983|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958984|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958985|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958986|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958987|NCT00929643|O1|Outcome|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958988|NCT00929643|E1|Reported Event|All Enrolled Participants|Hospitalized participants over 18 years of age, diagnosed with complicated intra-abdominal infections (cIAIs) who had received a procedure involving laparotomy/laparoscopy or percutaneous drainage of an intra-abdominal abscess; treatment followed standard clinical practice.
958989|NCT00929578|B1|Baseline|All Study Participants - Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
959029|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959030|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959456|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
958990|NCT00929578|P1|Participant Flow|All Study Participants|The sterile placebo: Bacteriostatic Sodium Chloride for Injection. Same subject will also receive dose in other arm of fluphenazine. This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
958991|NCT00929578|O3|Outcome|1 Week Post Dose|Participants with fluphenazine serum levels > 0.200ng/ml
958992|NCT00929578|O2|Outcome|2 Hours Post Dose|Number of participants with fluphenazine serum levels > 0.200ng/ml, 2 hours after administration
958994|NCT00929578|O1|Outcome|All Study Participants|Participants who experienced at least one adverse event.
958995|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
958996|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
958997|NCT00929578|O2|Outcome|Fluphenazine|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion.
958998|NCT00929578|O1|Outcome|Placebo|The sterile placebo: Bacteriostatic Sodium Chloride for Injection.
958999|NCT00929578|E1|Reported Event|All Study Participants|This will be an ascending dose study with the first cohort of 5 subjects dosed at 100 µg/mL, followed by cohorts at 500 and 2500 µg/mL. Dosing will be on Days 0, 7 and 14 and will consist of 5, or 10, 100 µL injections into the psoriatic lesion. The number of injections will depend on the lesion size. As this is a vehicle controlled study, subjects will receive intralesional injections of both drug and placebo, each into a separate target plaque, in a randomized fashion. All participants received medication, as the study was a split study, and subjects received placebo on one side and injection of fluphenazine on other side
959000|NCT00929526|B3|Baseline|Total|Total of all reporting groups
959001|NCT00929526|B2|Baseline|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959002|NCT00929526|B1|Baseline|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959003|NCT00929526|P2|Participant Flow|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959004|NCT00929526|P1|Participant Flow|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959005|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959006|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959007|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959008|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959009|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959010|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959011|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959012|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959013|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959014|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959015|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959016|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959017|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959018|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959019|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959020|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959021|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959022|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959023|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959024|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959025|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959026|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959027|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959028|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959031|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959032|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959033|NCT00929526|O2|Outcome|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959034|NCT00929526|O1|Outcome|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959035|NCT00929526|E2|Reported Event|Aimmugen Group|subjects received 3 doses of Aimmugen ™ vaccine in primary vaccination study NCT00316693.
959036|NCT00929526|E1|Reported Event|Cervarix Group|subjects received 3 doses of Cervarix™ vaccine in primary vaccination study NCT00316693.
959037|NCT00929474|B3|Baseline|Total|Total of all reporting groups
961718|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
959038|NCT00929474|B2|Baseline|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
959039|NCT00929474|B1|Baseline|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
959040|NCT00929474|P2|Participant Flow|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
959041|NCT00929474|P1|Participant Flow|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
959042|NCT00929474|O2|Outcome|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
959043|NCT00929474|O1|Outcome|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
959044|NCT00929474|E2|Reported Event|Control|Control - SJM CRT (Group 2) : The patient's device is programmed to either simultaneous or sequential Bi-V pacing mode as per physician's discretion. The paced/sensed AV and V-V delays could be programmed empirically or optimized using any non-intracardiac electrogram (IEGM) based method as per sites standard of care. However, the Group 2 patients can be optimized only once within the first 4 weeks post CRT replacement. Any paced/sensed AV and V-V delay optimizations performed after 4 weeks post CRT replacement in Group 2 patients will be considered a protocol deviation.
959045|NCT00929474|E1|Reported Event|QuickOpt|QuickOpt - St. Jude Medical (SJM) cardiac resynchronization therapy (CRT) (Group 1) : The patient's device is programmed to sequential Bi-V pacing mode with paced/sensed atrio-ventricular (AV) and V-V delays optimized using QuickOpt. For Group 1 patients, optimization using QuickOpt is performed at enrollment, 3, 6, 9 and 12 month visits.
959046|NCT00929383|B1|Baseline|Patients Treated With a Wingspan Stent|Prospective, single arm, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959047|NCT00929383|P1|Participant Flow|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959048|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959049|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959050|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959051|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959052|NCT00929383|O1|Outcome|Patients Treated With a Wingspan Stent|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959107|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959053|NCT00929383|E1|Reported Event|Wingspan|Prospective, open label study of patients with symptomatic Intracranial Atherosclerotic disease scheduled for treatment with the Wingspan Stent and Gateway balloon system. The patients were treated endovascularly as per standard of care at each study site
959054|NCT00929357|B3|Baseline|Total|Total of all reporting groups
959055|NCT00929357|B2|Baseline|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959056|NCT00929357|B1|Baseline|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
961719|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
959057|NCT00929357|P2|Participant Flow|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959058|NCT00929357|P1|Participant Flow|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959059|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959060|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959061|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959062|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959063|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959064|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959065|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959066|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959067|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959068|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959069|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959070|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959071|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959072|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959073|NCT00929357|O2|Outcome|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959074|NCT00929357|O1|Outcome|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959075|NCT00929357|E2|Reported Event|Biologics|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a tumor necrosis factor (TNF)-alpha-blocker such as etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®) – may be administered in combination with a conventional DMARD.
959076|NCT00929357|E1|Reported Event|DMARDS|Participants had received disease-modifying basic Rheumatoid Arthritis (RA) therapy with a conventional anti-rheumatic drug (DMARDS) such as methotrexate, leflunomide, or a combination of these.
959077|NCT00929344|B4|Baseline|Total|Total of all reporting groups
959078|NCT00929344|B3|Baseline|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959079|NCT00929344|B2|Baseline|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959457|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959080|NCT00929344|B1|Baseline|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959081|NCT00929344|P3|Participant Flow|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959082|NCT00929344|P2|Participant Flow|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959083|NCT00929344|P1|Participant Flow|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959084|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959085|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959086|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959087|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959088|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959089|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959090|NCT00929344|O3|Outcome|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959091|NCT00929344|O2|Outcome|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959092|NCT00929344|O1|Outcome|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959093|NCT00929344|E3|Reported Event|Placebo|"Placebo: Matched placebo capsule administered 1 capsule am and 1 capsule pm for 12 week duration.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959094|NCT00929344|E2|Reported Event|Pregabalin|"Pregabalin: Two 150 mg capsules, 150 mg/am and 150 mg/pm (Total dose, 300mg/d), 12 week duration. Dose may be increased up to 600 mg/d or reduced to 150 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959095|NCT00929344|E1|Reported Event|Duloxetine|"Duloxetine: 40 mg capsule, Once daily/am, 12 week duration, placebo capsule administered pm. Dose may be increased up to 60 mg/d or reduced to 20 mg/d based on subject response and tolerability.~Standardized behavioral therapy: Standardized behavioral therapy 1 time per week for 12 week duration."
959096|NCT00929331|B3|Baseline|Total|Total of all reporting groups
959097|NCT00929331|B2|Baseline|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959098|NCT00929331|B1|Baseline|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959099|NCT00929331|P2|Participant Flow|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959100|NCT00929331|P1|Participant Flow|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959101|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959102|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959103|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959104|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959105|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959106|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959387|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
959108|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959109|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959110|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959111|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
961720|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
959112|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959113|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959114|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959115|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959116|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959117|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959118|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959119|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959120|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959121|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959122|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959123|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959124|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959125|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959126|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959127|NCT00929331|O2|Outcome|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959128|NCT00929331|O1|Outcome|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959129|NCT00929331|E2|Reported Event|Fluviral Elderly Group|Subjects over 60 years of age who received one dose of Fluviral ® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959130|NCT00929331|E1|Reported Event|Fluviral Adult Group|Subjects aged between 18 and 60 years who received one dose of Fluviral® (2009-2010 season) intramuscularly in the deltoid region of the non-dominant arm
959131|NCT00929305|B3|Baseline|Total|Total of all reporting groups
959132|NCT00929305|B2|Baseline|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
959133|NCT00929305|B1|Baseline|Placebo Laser|inactive laser light
959134|NCT00929305|P2|Participant Flow|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
959135|NCT00929305|P1|Participant Flow|Placebo Laser|inactive laser light
959136|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mW of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
959137|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
959138|NCT00929305|O2|Outcome|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
959139|NCT00929305|O1|Outcome|Placebo Laser|inactive laser light
959140|NCT00929305|E2|Reported Event|Erchonia PL2000|The Erchonia EVRL Laser emits 1 mw of red (635nm wavelength) light via an electric diode energy source (CDRH Class II). It is a hand-held device that uses rechargeable batteries or a separate AC power adapter.
959141|NCT00929305|E1|Reported Event|Placebo Laser|inactive laser light
959188|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959189|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959190|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959452|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959142|NCT00929240|B1|Baseline|Intial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
961721|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
959143|NCT00929240|P3|Participant Flow|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959144|NCT00929240|P2|Participant Flow|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (partial response [PR] or complete response [CR]) or disease stabilization (SD) received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959145|NCT00929240|P1|Participant Flow|Initial Treatment Phase: Bevacizumab Plus (+) Docetaxel|During the Initial Phase all participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 milligrams per square meter (mg/m^2) IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
959146|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
959147|NCT00929240|O1|Outcome|Initial Treatment Phase: Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first, along with docetaxel a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion.At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
959148|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959149|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959191|NCT00929162|E2|Reported Event|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959192|NCT00929162|E1|Reported Event|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959193|NCT00929110|B4|Baseline|Total|Total of all reporting groups
959271|NCT00928954|P2|Participant Flow|Memantine First, Then Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
959194|NCT00929110|B3|Baseline|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959274|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)~gabapentin: increasing to 1200 mg/day"
959275|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).~memantine: increasing to 40 mg/day"
959150|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959151|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959152|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959153|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959154|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959155|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959156|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959157|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959269|NCT00929071|E1|Reported Event|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
959385|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
959158|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959159|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959160|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959161|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959162|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959163|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959164|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959165|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959270|NCT00928954|B1|Baseline|All Study Participants|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
959453|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959166|NCT00929240|O2|Outcome|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959167|NCT00929240|O1|Outcome|Maintenance Phase: Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959168|NCT00929240|E3|Reported Event|Maintenance Phase: Bevacizumab + Capecitabine|During the Initial Phase participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or withdrawal, whichever occurred first, along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response were randomized to receive bevacizumab 15 mg/kg IV on Day 1 of each 3-week cycle plus capecitabine 1000 mg/m^2 twice daily on Days 1 to 14 of each 3 week cycle until disease progression, unacceptable toxicity, request for withdrawal or end of study, whichever occurred first. If one of the drugs was discontinued before disease progression, treatment was continued with the second drug until disease progression, unacceptable toxicity, withdrawal or end of study, whichever occurred first.
959169|NCT00929240|E2|Reported Event|Maintenance Phase:Bevacizumab|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first along with docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Phase, participants with an objective response (PR or CR) or SD received 15 mg/kg bevacizumab IV on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, participant request for withdrawal or end of study, whichever occurred first.
959170|NCT00929240|E1|Reported Event|Initial Treatment Phase:Bevacizumab + Docetaxel|During the Initial Phase all participants received bevacizumab 15 mg/kg IV on Day 1 of each 3 week cycle for a minimum of 3 cycles and a maximum of 6 cycles or until disease progression, unacceptable toxicity or participant request for withdrawal, whichever occurred first. Participants also received docetaxel, a recommended dose of 100 mg/m^2 IV administered on Day 1 of each cycle. Doses of 75 to 100 mg/m^2 of docetaxel could be administered at investigator's discretion. At the end of the Initial Treatment Phase, participants with an objective response (PR or CR) or SD following 3-6 cycles of bevacizumab + docetaxel were randomized to receive maintenance therapy with either bevacizumab alone or bevacizumab + capecitabine.
959171|NCT00929201|B1|Baseline|All Participants|All randomized participants
959172|NCT00929201|P2|Participant Flow|Sita/Met FDC Then Sita + Met|Sitagliptin/Metformin 50 mg/500 mg FDC tablet administered as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 2.
959173|NCT00929201|P1|Participant Flow|Sita + Met Then Sita/Met FDC|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose during Period 1 followed by a 7-day washout followed by sitagliptin/metformin (Sita/Met) 50/500 mg fixed-dose combination (FDC) tablet administered as a single dose during Period 2.
959174|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
959175|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
959176|NCT00929201|O2|Outcome|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg final marketed image (FMI) FDC tablet administered as a single dose
959177|NCT00929201|O1|Outcome|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
959178|NCT00929201|E2|Reported Event|Sita/Met FDC|Sitagliptin/Metformin 50 mg/500 mg FMI FDC tablet administered as a single dose
959179|NCT00929201|E1|Reported Event|Sita + Met|Sitagliptin 50 mg and metformin 500 mg individual tablets administered concomitantly as a single dose
959180|NCT00929162|B3|Baseline|Total|Total of all reporting groups
959181|NCT00929162|B2|Baseline|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959182|NCT00929162|B1|Baseline|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959183|NCT00929162|P2|Participant Flow|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959184|NCT00929162|P1|Participant Flow|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959185|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959186|NCT00929162|O1|Outcome|ZD4054+Paclitaxel+Carboplatin|ZD4054 10mg oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959187|NCT00929162|O2|Outcome|Placebo+Paclitaxel+Carboplatin|Placebo oral tablet once daily + paclitaxel +carboplatin intravenous infusions every 3 weeks
959386|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959195|NCT00929110|B2|Baseline|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959196|NCT00929110|B1|Baseline|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959197|NCT00929110|P3|Participant Flow|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959198|NCT00929110|P2|Participant Flow|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959199|NCT00929110|P1|Participant Flow|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959200|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959201|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959202|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959203|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959204|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959205|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959206|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959207|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959208|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959209|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959210|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959211|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959458|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959212|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959213|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959214|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959215|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959216|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959217|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959218|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959219|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959220|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959221|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959222|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959223|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959224|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959225|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959226|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959227|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959228|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959229|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
961690|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
959230|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959231|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959232|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959233|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959234|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959235|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959236|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959237|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959238|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959239|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959240|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959241|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959242|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959243|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959244|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959245|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959246|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959247|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
961691|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
959248|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959249|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959250|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959251|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959252|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959253|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959254|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959255|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959256|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959257|NCT00929110|O3|Outcome|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959258|NCT00929110|O2|Outcome|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959259|NCT00929110|O1|Outcome|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959260|NCT00929110|E3|Reported Event|Tiotropium 18 μg|Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959261|NCT00929110|E2|Reported Event|Placebo to Glycopyrronium Bromide|Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959262|NCT00929110|E1|Reported Event|Glycopyrronium Bromide 50 μg|Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
959263|NCT00929071|B1|Baseline|Pain Assessment|Assess injection pain of Evolence/topical anesthetic vs Evolence/Lidocaine mixture upon injection
959264|NCT00929071|P1|Participant Flow|All Study Participants|Assess a difference in immediate post-injection pain of Evolence/topical anesthetic at the left nasolabial fold vs Evolence/Lidocaine at the right nasolabial fold.
959265|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine~collagen: Injectable collagen~Lidocaine: admix anesthetic"
959266|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic~collagen: Injectable collagen~topical anesthetic"
959267|NCT00929071|O2|Outcome|Pain Assessment for Evolence/Lidocaine|"Assess injection pain of Evolence/Lidocaine right nasolabial fold~collagen: Injectable collagen~Lidocaine: admix anesthetic"
959268|NCT00929071|O1|Outcome|Pain Assessment for Evolence/Topical Anesthetic|"Assess injection pain of Evolence/topical anesthetic left nasolabial fold~collagen: Injectable collagen~topical anesthetic"
959454|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959272|NCT00928954|P1|Participant Flow|Gabapentin First and Then Memantine|"Increasing dose to 300 mg four times per day (total of 1200 mg/day) for the gabapentin.~Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day) for memantine."
959273|NCT00928954|O2|Outcome|Memantine|"Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).~memantine: increasing to 40 mg/day"
959276|NCT00928954|O1|Outcome|Gabapentin|"Increasing dose to 300 mg four times per day (total of 1200 mg/day)~gabapentin: increasing to 1200 mg/day"
959277|NCT00928954|E2|Reported Event|Memantine|Increasing dose over two weeks to 20 mg twice/day (total of 40 mg/day).
959278|NCT00928954|E1|Reported Event|Gabapentin|Increasing dose to 300 mg four times per day (total of 1200 mg/day)
959279|NCT00928889|B3|Baseline|Total|Total of all reporting groups
959280|NCT00928889|B2|Baseline|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959281|NCT00928889|B1|Baseline|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959282|NCT00928889|P2|Participant Flow|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959283|NCT00928889|P1|Participant Flow|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959284|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959285|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959286|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959287|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959288|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959289|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959290|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959291|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959292|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959293|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959294|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959295|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959296|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959297|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959298|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959299|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959300|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959301|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959302|NCT00928889|O2|Outcome|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959303|NCT00928889|O1|Outcome|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959304|NCT00928889|E2|Reported Event|Acarbose 50 mg|Acarbose 50 mg was taken orally 3 times daily, with the first bite of food at meals for 4 weeks.
959305|NCT00928889|E1|Reported Event|Nateglinide 120 mg|Nateglinide was taken orally 3 times daily, 10 minutes before meals for 4 weeks.
959306|NCT00928772|B4|Baseline|Total|Total of all reporting groups
959307|NCT00928772|B3|Baseline|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
959308|NCT00928772|B2|Baseline|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
959309|NCT00928772|B1|Baseline|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
959310|NCT00928772|P3|Participant Flow|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
959311|NCT00928772|P2|Participant Flow|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
959312|NCT00928772|P1|Participant Flow|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
959313|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
959314|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
959315|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
959316|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
959466|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959317|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
959318|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
959319|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
959320|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
959321|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
959322|NCT00928772|O3|Outcome|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
959323|NCT00928772|O2|Outcome|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
959324|NCT00928772|O1|Outcome|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
959325|NCT00928772|E3|Reported Event|Placebo|"No Alpha-Stim and only topical anesthetics~NO SEDATION WITH SHAM CRANIAL ELECTROSTIMULATION AND PLACEBO VERSED: NO ACTIVE SEDATION, ONLY SHAM ELECTRODES AND NORMAL SALINE SIMULATING MIDAZOLAM."
959326|NCT00928772|E2|Reported Event|Sham Alpha-Stim With Midazolam|"Sham Alpha-Stim intervention with real midazolam administration~MIDAZOLAM + SHAM ELECTRODES SIMULATING CRANIAL ELECTROTHERAPY: CONVENTIONAL METHOD OF PERIOPERATIVE SEDATION"
959327|NCT00928772|E1|Reported Event|Alpha-Stim Intervention|"One hour Alpha-Stim intervention with sham midazolam~CRANIAL ELECTROTHERAPY (Alpha Stim) + SHAM MIDAZOLAM: APPLYING OF ELECTRODES ON THE EAR LOBES AND TEMPLES WHICH ARE SENDING AN ACTIVE MICROCURRENT THROUGH THE MIDBRAIN PRODUCING SEDATION WITHOUT PHARMACOLOGICAL AGENTS AND GIVING NORMAL SALINE AS A SHAM DRUG SEDATION"
959328|NCT00928746|B1|Baseline|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
959329|NCT00928746|P1|Participant Flow|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
959330|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959331|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959332|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959333|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959334|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959335|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959336|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959337|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959338|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959339|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959340|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959341|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959342|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959343|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959344|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations Group
959345|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg - Oral inhalation) - 180 Actuations group
959346|NCT00928746|O1|Outcome|ATROVENT 42mcg|ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
959347|NCT00928746|E1|Reported Event|ATROVENT 42mcg|ATROVENT HFA (42 mcg)- Oral inhalation
959348|NCT00928720|B4|Baseline|Total|Total of all reporting groups
959349|NCT00928720|B3|Baseline|Usual Care Alone|No intervention; participants will received usual medical care for fibromyalgia
959350|NCT00928720|B2|Baseline|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
959351|NCT00928720|B1|Baseline|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
959352|NCT00928720|P3|Participant Flow|Usual Care Alone|No intervention; usual medical care for fibromyalgia
959455|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959353|NCT00928720|P2|Participant Flow|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
959391|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959467|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959354|NCT00928720|P1|Participant Flow|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
959355|NCT00928720|O3|Outcome|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
959356|NCT00928720|O2|Outcome|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
959357|NCT00928720|O1|Outcome|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
959358|NCT00928720|E3|Reported Event|Usual Care Alone|No intervention; participants will receive usual medical care for fibromyalgia
959359|NCT00928720|E2|Reported Event|Sham Device|"Participants will use the device for 60 continuous minutes each day for 8 weeks. The sham device will look the same as the active CES device; however, no electrical stimulation will be present in the sham device.~sham device: The sham device will look the same as the active CES (Alpha-Stim); however, no electrical stimulation will be present in the sham device."
959360|NCT00928720|E1|Reported Event|CES Device|cranial electrical stimulation (CES) device (Alpha-Stim): Participants will use the device for 60 continuous minutes each day for 8 weeks. The CES device will be preset at the factory to provide a maximum of 60 minutes of modified square-wave biphasic stimulation at 0.5 Hz and 100µA, the lowest setting that has been used in previous studies with patients with FM.
959361|NCT00928694|B1|Baseline|All Participants|
959362|NCT00928694|P2|Participant Flow|SUPRALIP™ First, Then TRICOR™|UK formulation (SUPRALIP™) 160 mg tablet / U.S. formulation (TRICOR™) 160 mg tablet
959363|NCT00928694|P1|Participant Flow|TRICOR™ First, Then SUPRALIP™|U.S. formulation (TRICOR™) 160 mg tablet/ UK formulation (SUPRALIP™) 160 mg tablet
959364|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
959365|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
959366|NCT00928694|O2|Outcome|UK Formulation (SUPRALIP™)|UK Formulation: single oral 160 mg dose of the UK formulation of fenofibrate with food.
959367|NCT00928694|O1|Outcome|U.S. Formulation (TRICOR™)|U.S. Formulation: single oral 160 mg dose of the U.S. formulation of fenofibrate with food.
959368|NCT00928694|E2|Reported Event|Supralip™|UK formulation (SUPRALIP™) 160 mg tablet
959369|NCT00928694|E1|Reported Event|Tricor™|U.S. formulation (TRICOR™) 160 mg tablet
959370|NCT00928668|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, placebo-controlled, 5-way crossover trial. 31 patients were assigned randomly to one of 5 treatment sequences in which they received each of 5 treatments. The duration of each treatment period was 1 day with a 14 day washout period between treatments.
959371|NCT00928668|P5|Participant Flow|Placebo / Olo 10mcg / Olo 5mcg / Olo 20mcg / Olo 2mcg|Patients were administered matching Placebo in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period, Olodaterol 20 mcg qd in the fourth period and Olodaterol 2 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
959372|NCT00928668|P4|Participant Flow|Olo 20mcg / Olo 5mcg / Placebo / Olo 2mcg / Olo 10mcg|Patients were administered Olodaterol 20 mcg qd in the first period, Olodaterol 5 mcg qd in the second period, matching Placebo in the third period, Olodaterol 2 mcg qd in the fourth period and Olodaterol 10 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
959373|NCT00928668|P3|Participant Flow|Olo 2mcg / Placebo / Olo 20mcg / Olo 10mcg / Olo 5mcg|Patients were administered Olodaterol 2 mcg qd in the first period, matching Placebo in the second period, Olodaterol 20 mcg qd in the third period, Olodaterol 10 mcg qd in the fourth period and Olodaterol 5 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
959374|NCT00928668|P2|Participant Flow|Olo 10mcg / Olo 20mcg / Olo 2mcg / Olo 5mcg / Placebo|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 20 mcg qd in the second period, Olodaterol 2 mcg qd in the third period, Olodaterol 5 mcg qd in the fourth period and matching Placebo in the fifth period. Olodaterol was administered via the Respimat inhaler.
959375|NCT00928668|P1|Participant Flow|Olo 5mcg / Olo 2mcg / Olo 10mcg / Placebo / Olo 20mcg|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg qd in the second period, Olodaterol 10 mcg qd in the third period, matching Placebo in the fourth period and Olodaterol 20 mcg qd in the fifth period. Olodaterol was administered via the Respimat inhaler.
959376|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959377|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
959378|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
959379|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
959380|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
959381|NCT00928668|O5|Outcome|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959382|NCT00928668|O4|Outcome|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
959383|NCT00928668|O3|Outcome|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
959384|NCT00928668|O2|Outcome|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
959388|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
959389|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
959390|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
959468|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959392|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
959393|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
959394|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
959395|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
959396|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959397|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
959398|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
959399|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
959400|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
959401|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959402|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
959403|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
959404|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
959405|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
959406|NCT00928668|O5|Outcome|Olodaterol (Olo) 20 mcg qd|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959407|NCT00928668|O4|Outcome|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
959408|NCT00928668|O3|Outcome|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
959409|NCT00928668|O2|Outcome|Olodaterol (Olo) 2 mcg qd|Olodaterol 2 mcg qd delivered by the Respimat Inhaler.
959410|NCT00928668|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
959411|NCT00928668|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd delivered by the Respimat Inhaler.
959412|NCT00928668|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
959413|NCT00928668|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
959414|NCT00928668|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
959415|NCT00928668|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat resp. Aerolizer Inhaler.
959416|NCT00928642|B1|Baseline|Treatment|Open label, non-randomized, single treatment group.
959417|NCT00928642|P1|Participant Flow|Oral Imatinib Plus Gemcitabine|Open label, non-randomized, single treatment group.
959418|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
959419|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
959420|NCT00928642|O1|Outcome|Treatment|Open label, non-randomized, single treatment group.
959421|NCT00928642|O1|Outcome|Oral Imatinib Plus IV Gemcitabine|Open label, non-randomized, single treatment group. all subjects had epithelial ovarian cancer or primary peritoneal carcinomatosis that progressed after prior treatment.
959422|NCT00928642|O1|Outcome|Oral Imatinib Puls IV Gemcitabine|Open label, non-randomized, single treatment group.
959423|NCT00928642|O1|Outcome|Oral Imatinib Plus Gemcitabine|"Open label, non-randomized, single treatment group.~All subjects has measurable or evaluabel epithelial ovarian cancer or preitoneal carcinomatosis. all subjects were treated with oral imatinib and IV gemcitabine."
959424|NCT00928642|E1|Reported Event|Treatment|Open label, non-randomized, single treatment group.
959425|NCT00928512|B6|Baseline|Total|Total of all reporting groups
959426|NCT00928512|B5|Baseline|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959427|NCT00928512|B4|Baseline|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959428|NCT00928512|B3|Baseline|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959429|NCT00928512|B2|Baseline|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959430|NCT00928512|B1|Baseline|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959431|NCT00928512|P5|Participant Flow|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959432|NCT00928512|P4|Participant Flow|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959433|NCT00928512|P3|Participant Flow|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959434|NCT00928512|P2|Participant Flow|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959435|NCT00928512|P1|Participant Flow|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959436|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959437|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959438|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959439|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959440|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959441|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959442|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959443|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959444|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959445|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959446|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959447|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959448|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959449|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959450|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959451|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959459|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959460|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959461|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959462|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959463|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959469|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959470|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959471|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959472|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959473|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959474|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959475|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959476|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959477|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959478|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959479|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959480|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959481|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959482|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959483|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959484|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959485|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959486|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959487|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959488|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959489|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959490|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959491|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959492|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959493|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959494|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959495|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959496|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959497|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959498|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959499|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959500|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959501|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959502|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959503|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959504|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959505|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959506|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959507|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959508|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959509|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959510|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959511|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959512|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959513|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959514|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959515|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959516|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959517|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959518|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959519|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959520|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959521|NCT00928512|O5|Outcome|Secukinumab Placebo|Secukinumab Placebo s.c. q4wk
959522|NCT00928512|O4|Outcome|Secukinumab 25mg|Secukinumab 25mg s.c. q4wk
959523|NCT00928512|O3|Outcome|Secukinumab 75mg|Secukinumab 75mg s.c. q4wk
959524|NCT00928512|O2|Outcome|Secukinumab 150mg|Secukinumab 150mg s.c. q4wk
959525|NCT00928512|O1|Outcome|Secukinumab 300mg|Secukinumab 300mg s.c. q4wk
959526|NCT00928512|E9|Reported Event|AIN457 300mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 300mg
959527|NCT00928512|E8|Reported Event|AIN457 150mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 150mg
959528|NCT00928512|E7|Reported Event|AIN457 75mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 75mg
959529|NCT00928512|E6|Reported Event|AIN457 25mg (Wk 20 to End of Study)|From week 20 through end of study - AIN457 25mg
959530|NCT00928512|E5|Reported Event|Placebo|Up to Week 20 - Placebo
959531|NCT00928512|E4|Reported Event|AIN457 300mg|Up to Week 20 - AIN457 300mg
959532|NCT00928512|E3|Reported Event|AIN457 150mg|Up to Week 20 - AIN457 150mg
959533|NCT00928512|E2|Reported Event|AIN457 75mg|Up to Week 20 - AIN457 75mg
959534|NCT00928512|E1|Reported Event|AIN457 25mg|Up to Week 20 - AIN457 25mg
959535|NCT00928486|B1|Baseline|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
959675|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
961722|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
959536|NCT00928486|P1|Participant Flow|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
959537|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
959538|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
959539|NCT00928486|O1|Outcome|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
959540|NCT00928486|E1|Reported Event|Lenalidomide and Dexamethasone|Lenalidomide 25mg by mouth (PO) once daily (QD) on Days 1-21 of each 28 day cycle; When creatinine (CrCl) clearance <60 mL/min, the initial dose was 10mg and the dose could be increased to 15mg after 2 cycles if the investigator judged therapeutic effect was insufficient and tolerability was acceptable. Dexamethasone 40 mg by PO once QD on days 1-4, 9-12 and 17-20 of each 28 day cycle for the first 4 cycles and Days 1-4 for the remaining cycles beginning at Cycle 5.
959541|NCT00928434|B4|Baseline|Total|Total of all reporting groups
959542|NCT00928434|B3|Baseline|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0, administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. as per manufacturer’s labeling directions at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)"
959543|NCT00928434|B2|Baseline|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959544|NCT00928434|B1|Baseline|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959545|NCT00928434|P3|Participant Flow|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959546|NCT00928434|P2|Participant Flow|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959547|NCT00928434|P1|Participant Flow|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959676|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959971|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959548|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959549|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959550|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959551|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959552|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959553|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959554|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959555|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959556|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959557|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959753|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959558|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959559|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959560|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959561|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959562|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 were administered.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959563|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959564|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959565|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959566|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959567|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959568|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959569|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959671|NCT00928187|B1|Baseline|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959754|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
959570|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959571|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959572|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959573|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959574|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959575|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959576|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959577|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959578|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959579|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959580|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959581|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959672|NCT00928187|P3|Participant Flow|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959906|NCT00928057|O2|Outcome|5 mm PN|Use of 5 mm PN for insulin injections for 3 weeks.
959582|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959583|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959584|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959585|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959586|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959587|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959588|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959589|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959590|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959591|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959592|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959593|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959673|NCT00928187|P2|Participant Flow|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
961692|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
959594|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959595|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959596|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
959597|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959598|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959599|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959600|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
959601|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959602|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959603|NCT00928434|O4|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959604|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3- month depot each)."
959605|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each. Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959674|NCT00928187|P1|Participant Flow|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959755|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
961693|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
959606|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959607|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959608|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959609|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959610|NCT00928434|O3|Outcome|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959611|NCT00928434|O2|Outcome|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959612|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959613|NCT00928434|O2|Outcome|Total Continuous|This is the combination of degarelix continuous and leuprolide continuous treatment arms.
959614|NCT00928434|O1|Outcome|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959615|NCT00928434|E3|Reported Event|LC (Leuprolide Continuous)|"Patients in this arm received leuprolide 7.5 mg one-month depot injection on Day 0 (Visit 1), administered intramuscular (i.m.) into a large muscle, as per manufacturer’s labeling directions.~One injection of 22.5 mg leuprolide 3-month depot was administered i.m. into a large muscle, according to the directions for use in the manufacturer’s labeling at Day 28 and every 3 months afterwards for 4 additional doses (i.e at Days 112, 196, 280, and 364, respectively).~On Investigator’s discretion, patients in the arm could take bicalutamide (Casodex®) for a maximum of 28 days to alleviate increased signs and symptoms due to initial upsurge in testosterone levels.~Leuprolide: Leuprolide treatment for complete study period (one starting dose and 5 maintenance doses of 3-month depot each)."
959616|NCT00928434|E2|Reported Event|DC (Degarelix Continuous)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL administered on Day 0 (Visit 1) s.c. into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Thirteen maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 364, administered s.c. into the anterior abdominal wall.~Degarelix: Degarelix treatment provided for complete study period (one starting dose and 13 maintenance doses)."
959617|NCT00928434|E1|Reported Event|DI (Degarelix Intermittent)|"Patients in this arm received degarelix with a starting dose of 240 mg at a concentration of 40 mg/mL on Day 0 (Visit 1) administered subcutaneously (s.c.) into the anterior abdominal wall via two equivalent injections of 120 mg (3 mL) each.~Six maintenance doses of degarelix 80 mg per month at a concentration of 20 mg/mL (4 mL) at Days 28 to 168 (Visit 2 through 7), administered s.c. into the anterior abdominal wall.~During Phase B of the trial, If a patient had Prostate Specific Antigen (PSA) ≥2 ng/mL at any visit, additional doses of degarelix 240 mg followed by 80 mg maintenance dose(s) were administered.~Degarelix: Degarelix treatment provided for first seven months (one starting dose and six maintenance doses) followed by no treatment for next seven months period."
959618|NCT00928421|B1|Baseline|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
959619|NCT00928421|P1|Participant Flow|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
959620|NCT00928421|O1|Outcome|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
959621|NCT00928421|E1|Reported Event|Polidocanol Injectable Foam 0.125%|polidocanol injectable foam 0.125%, single dose
959622|NCT00928408|B1|Baseline|Cinacalcet|
959623|NCT00928408|P1|Participant Flow|Cinacalcet|
959624|NCT00928408|O1|Outcome|Cinacalcet|
959625|NCT00928408|O1|Outcome|Cinacalcet|
959626|NCT00928408|O1|Outcome|Cinacalcet|
959627|NCT00928408|O1|Outcome|Cinacalcet|
959628|NCT00928408|O1|Outcome|Cinacalcet|
959629|NCT00928408|O1|Outcome|Cinacalcet|
959630|NCT00928408|O1|Outcome|Cinacalcet|
959631|NCT00928408|O1|Outcome|Cinacalcet|
959632|NCT00928408|O1|Outcome|Cinacalcet|
959633|NCT00928408|O1|Outcome|Cinacalcet|
959634|NCT00928408|O1|Outcome|Cinacalcet|
959635|NCT00928408|O1|Outcome|Cinacalcet|
959636|NCT00928408|O1|Outcome|Cinacalcet|
959637|NCT00928408|O1|Outcome|Cinacalcet|
959638|NCT00928408|O1|Outcome|Cinacalcet|
959639|NCT00928408|O1|Outcome|Cinacalcet|
959640|NCT00928408|O1|Outcome|Cinacalcet|
959641|NCT00928408|O1|Outcome|Cinacalcet|
959642|NCT00928408|O1|Outcome|Cinacalcet|
959643|NCT00928408|O1|Outcome|Cinacalcet|
959644|NCT00928408|O1|Outcome|Cinacalcet|
959645|NCT00928408|O1|Outcome|Cinacalcet|
959646|NCT00928408|O1|Outcome|Cinacalcet|
959647|NCT00928408|O1|Outcome|Cinacalcet|
959648|NCT00928408|O1|Outcome|Cinacalcet|
959649|NCT00928408|O1|Outcome|Cinacalcet|
959650|NCT00928408|E1|Reported Event|Cinacalcet|
959651|NCT00928395|B1|Baseline|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
959652|NCT00928395|P1|Participant Flow|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
959653|NCT00928395|O1|Outcome|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
959654|NCT00928395|E1|Reported Event|Urgent PC|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
959655|NCT00928304|B1|Baseline|Subjects Enrolled in Study|All Down Syndrome and healthy volunteer subjects
959656|NCT00928304|P2|Participant Flow|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
959657|NCT00928304|P1|Participant Flow|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172) : 300 megabecquerels (MBq) single IV injection of 2 to 10 mL
959658|NCT00928304|O3|Outcome|Healthy Volunteer Group|All healthy volunteers enrolled in the study
959659|NCT00928304|O2|Outcome|Down Syndrome PET-negative (Majority Read)|Down Syndrome subjects negative for cerebral beta-amyloid as determined by majority read
959660|NCT00928304|O1|Outcome|Down Syndrome PET-positive (Majority Read)|Down Syndrome subjects positive for cerebral beta-amyloid as determined by majority read
959661|NCT00928304|O2|Outcome|Healthy Volunteer Group|Healthy volunteers enrolled in the study
959662|NCT00928304|O1|Outcome|Down Syndrome Group|Subjects with Down Syndrome enrolled in the study
959663|NCT00928304|O2|Outcome|Majority Read (DS-Old)|Majority Read results for Down Syndrome subjects with age >46 yrs
959664|NCT00928304|O1|Outcome|Majority Read (DS-Young)|Majority Read results for Down Syndrome subjects with age <= 46 yrs
959665|NCT00928304|O1|Outcome|Majority Read|Majority read of the visual assessment made by 3 independent readers of PET images from all subjects.
959666|NCT00928304|E2|Reported Event|Healthy Volunteer Group|70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
959667|NCT00928304|E1|Reported Event|Down Syndrome Group|39 Down Syndrome subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL
959668|NCT00928187|B4|Baseline|Total|Total of all reporting groups
959669|NCT00928187|B3|Baseline|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959670|NCT00928187|B2|Baseline|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
961694|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
959677|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959678|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959679|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959680|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959681|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959682|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959683|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959684|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959685|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959686|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959687|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959688|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959689|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959690|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959691|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959692|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959693|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959751|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959905|NCT00928057|O3|Outcome|8 mm PN|Use of 8 mm PN for insulin injections for 3 weeks.
959694|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959695|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959696|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959697|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959698|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959699|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959700|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959701|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959702|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959703|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959704|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959705|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959706|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959707|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959708|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959709|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959710|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959711|NCT00928187|O3|Outcome|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959712|NCT00928187|O2|Outcome|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959752|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959713|NCT00928187|O1|Outcome|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959714|NCT00928187|E3|Reported Event|Arm C|"emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation)~emtricitabine/tenofovir + darunavir + ritonavir (Second line strategy under evaluation): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + darunavir 400 mg 2 tablets + ritonavir 100 mg 1 capsule, in a single dose with food"
959911|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN
959715|NCT00928187|E2|Reported Event|Arm B|"abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line)~abacavir + didanosine + lopinavir/ritonavir (WHO recommended second line): Didanosine 1 entero-coated capsule/day in fasting conditions (dosage 250 mg if weight < 60 kg, 400 mg if weight > 60 kg) + abacavir 300 mg 1 tablet in the morning and in the evening + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets morning and evening"
959716|NCT00928187|E1|Reported Event|Arm A|"emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line)~emtricitabine/tenofovir + lopinavir/ritonavir (WHO recommended second line): Emtricitabine 200 mg/tenofovir 300 mg 1 tablet/day with food + Lopinavir 200 mg/Ritonavir 50 mg 2 tablets in the morning and 2 tablets in the evening"
959717|NCT00928174|B1|Baseline|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
959718|NCT00928174|P1|Participant Flow|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
959719|NCT00928174|O1|Outcome|Single Arm|"fluourine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 fluoromethylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
959720|NCT00928174|E1|Reported Event|Single Arm|"Fluorine-18 fluorocholine IV in conjunction with PET/CT imaging, up to 3 doses.~IV administration of fluorine-18 methylcholine followed by PET/CT imaging: Imaging intervention performed prior to and 30-75 days post a change in anti-androgen therapy."
959721|NCT00928083|B4|Baseline|Total|Total of all reporting groups
959722|NCT00928083|B3|Baseline|Part C - OZ439 Multiple Rising Dose|Subjects were assigned to individual dose cohorts (200, 400 and 800 mg OZ439) and placebo.
959723|NCT00928083|B2|Baseline|Part B - OZ439 Food Effect|"Subjects were randomized to sequence groups, fasted/fed or fed/fasted while receiving a single dose of 800 mg OZ439."
959724|NCT00928083|B1|Baseline|Part A - OZ439 Single Rising Dose|Included 3 Cohorts, where subjects in cohorts 1 and 2 were randomized to a treatment sequence, receiving doses of OZ439 on four occasions and placebo on one occasion, and subjects in Cohort 3 were administered increasing doses of the oral dispersion.
959725|NCT00928083|P9|Participant Flow|Part C - Placebo|Part C - Placebo
959726|NCT00928083|P8|Participant Flow|Part C - 800mg OZ439 Multiple Dose|OZ439 800mg for 3 consecutive days
959727|NCT00928083|P7|Participant Flow|Part C - 400mg OZ439 Multiple Dose|OZ439 400mg for 3 consecutive days
959728|NCT00928083|P6|Participant Flow|Part C - 200mg OZ439 Multiple Dose|200mg OZ439 for 3 consecutive days
959729|NCT00928083|P5|Participant Flow|Part B - Food Effect - Cohort 2|Food Effect - Cohort 2 800mg OZ439 Fed then Fasted
959730|NCT00928083|P4|Participant Flow|Part B - Food Effect - Cohort 1|Food Effect - Cohort 1 800mg OZ439 Fasted then Fed
959731|NCT00928083|P3|Participant Flow|Part A - OZ439 Single Dose - Cohort 3|Oral Dispersion OZ439 50-1600 mg
959732|NCT00928083|P2|Participant Flow|Part A - OZ439 Single Dose - Cohort 2|OZ439 50 mg, then 100 mg, then 400 mg, then 1200 mg, then Placebo
959733|NCT00928083|P1|Participant Flow|Part A - OZ439 Single Dose - Cohort 1|OZ439 50 mg then 200 mg, then 800 mg, then 1600 mg, then Placebo
959734|NCT00928083|O3|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959735|NCT00928083|O2|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959736|NCT00928083|O1|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959737|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959738|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959739|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959740|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
959741|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
959742|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
959743|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
959744|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
959745|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
959746|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
959747|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959748|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
959749|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
959750|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
959756|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
959757|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
959758|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
959759|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
959760|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
959761|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959762|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
959763|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
959764|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
959765|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959766|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959767|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959768|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
959769|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
959770|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
959771|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
959772|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
959773|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
959774|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
959775|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959776|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
959777|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
959778|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
959779|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959780|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959781|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959782|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
959783|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
959784|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
959785|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
959786|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
959787|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
959788|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
959789|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959790|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
959791|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
959792|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
959793|NCT00928083|O14|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959794|NCT00928083|O13|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959795|NCT00928083|O12|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959796|NCT00928083|O11|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
959797|NCT00928083|O10|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
959798|NCT00928083|O9|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
959799|NCT00928083|O8|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
959800|NCT00928083|O7|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
959801|NCT00928083|O6|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
959802|NCT00928083|O5|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
959803|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959804|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
959805|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
959806|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
959807|NCT00928083|O17|Outcome|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
959808|NCT00928083|O16|Outcome|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959809|NCT00928083|O15|Outcome|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959810|NCT00928083|O14|Outcome|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959811|NCT00928083|O13|Outcome|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
959812|NCT00928083|O12|Outcome|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
959813|NCT00928083|O11|Outcome|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
959814|NCT00928083|O10|Outcome|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
959815|NCT00928083|O9|Outcome|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
959816|NCT00928083|O8|Outcome|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
959817|NCT00928083|O7|Outcome|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
959818|NCT00928083|O6|Outcome|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
959819|NCT00928083|O5|Outcome|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959820|NCT00928083|O4|Outcome|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959821|NCT00928083|O3|Outcome|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
959822|NCT00928083|O2|Outcome|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
959823|NCT00928083|O1|Outcome|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
959824|NCT00928083|E17|Reported Event|Part C - Placebo|"Placebo control for Multiple rising Part C~Placebo"
959825|NCT00928083|E16|Reported Event|Part C - 800mg AD Multiple Dose|"800mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 800mg aqueous dispersion"
959826|NCT00928083|E15|Reported Event|Part C - 400mg AD Multiple Dose|"400mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 400mg aqueous dispersion"
959827|NCT00928083|E14|Reported Event|Part C - 200mg AD Multiple Dose|"200mg aqueous solution OZ439 or placebo once daily for 3 days fasted~OZ439 200mg aqueous dispersion"
959828|NCT00928083|E13|Reported Event|Part B - 800mg AD Single Dose Fast|"Single dose of OZ439 800mg aqueous dispersion administered under fast conditions~OZ439 800mg aqueous dispersion"
959829|NCT00928083|E12|Reported Event|Part B - 800mg AD Single Dose Fed|"Single dose of OZ439 800mg aqueous dispersion administered under fed conditions~OZ439 800mg aqueous dispersion"
959830|NCT00928083|E11|Reported Event|Part A - Placebo|"Placebo control for Single rising Part A~Placebo"
959831|NCT00928083|E10|Reported Event|Part A - 1600mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 1600mg aqueous dispersion"
959832|NCT00928083|E9|Reported Event|Part A - 1200mg Single Dose|"OZ439 Single doses of 1200mg (capsules)~OZ439 1200mg API capsules: OZ439 1200mg (6x200mg API capsules)"
959833|NCT00928083|E8|Reported Event|Part A - 800mg AD Single Dose|"OZ439 Single doses of 800mg (aqueous dispersion)~OZ439 800mg aqueous dispersion"
959834|NCT00928083|E7|Reported Event|Part A - 800mg Single Dose|"OZ439 Single doses of 800mg (capsules)~OZ439 800mg API capsules: OZ439 800mg (4x200 API capsules)"
959835|NCT00928083|E6|Reported Event|Part A - 400mg AD Single Dose|"OZ439 Single doses of 400mg (aqueous dispersion)~OZ439 400mg aqueous dispersion"
959836|NCT00928083|E5|Reported Event|Part A - 400mg Single Dose + Food|"OZ439 Single doses of 400mg (capsules) administered with food.~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959837|NCT00928083|E4|Reported Event|Part A - 400mg Single Dose|"OZ439 Single doses of 400mg (capsules)~OZ439 400mg API capsules: OZ439 400mg (2x200mg API capsules)"
959838|NCT00928083|E3|Reported Event|Part A - 200mg Single Dose|"OZ439 Single doses of 200mg (capsules)~OZ439 200mg API capsules"
959839|NCT00928083|E2|Reported Event|Part A - 100mg Single Dose|"OZ439 Single doses of 100mg (capsules)~OZ439 100mg API capsules: OZ439 100mg (2x50mg API capsules)"
959840|NCT00928083|E1|Reported Event|Part A - 50 mg Single Dose|"OZ439 Single doses of 50mg (capsules)~OZ439 50mg API capsules"
959841|NCT00928070|B3|Baseline|Total|Total of all reporting groups
959842|NCT00928070|B2|Baseline|Fesoterodine|Participants who received fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959843|NCT00928070|B1|Baseline|Placebo|Participants who received placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959844|NCT00928070|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
961695|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
959845|NCT00928070|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959846|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959912|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN
959847|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959848|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959849|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959850|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959851|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959852|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959853|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959854|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959855|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959856|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959857|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959858|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959859|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959860|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959861|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959862|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959863|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959864|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959865|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959866|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959867|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959868|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959869|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959870|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959871|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959872|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959873|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959874|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959875|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959876|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959877|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959878|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959879|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959880|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959881|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959882|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959883|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959884|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959885|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959886|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959887|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959888|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959889|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959890|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959891|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959892|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959893|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959894|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959895|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959896|NCT00928070|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959897|NCT00928070|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959898|NCT00928070|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by an optional dose-escalation to 8 mg once daily at investigator’s discretion for remaining 8 weeks.
959899|NCT00928070|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily as part of optional dose escalation at investigator's discretion for remaining 8 weeks.
959900|NCT00928057|B3|Baseline|Total|Total of all reporting groups
959901|NCT00928057|B2|Baseline|4 mm / 5 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 5 mm pen needles, regardless of whether they completed the study.
959902|NCT00928057|B1|Baseline|4 mm / 8 mm PN|This group represents all subjects that were randomized to the study arm comparing the 4 mm and 8 mm pen needles, regardless of whether they completed the study.
959903|NCT00928057|P2|Participant Flow|4 mm / 5 mm PN|This group represents all subjects that were randomized to compare the 4mm and 5mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
959904|NCT00928057|P1|Participant Flow|4 mm / 8 mm PN|This group represents all subjects that were randomized to compare the 4mm and 8mm pen needle (PN) during the study. Each PN was used for 3 consecutive weeks; which PN was used first was based on the subject's randomization assignment.
959907|NCT00928057|O1|Outcome|4 mm PN|Use of 4 mm PN for insulin injections for 3 weeks.
959908|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
959909|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
959910|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN
959913|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
959914|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
959915|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
959916|NCT00928057|O3|Outcome|8 mm PN|All randomized subjects that used the 8mm PN, either during the first or second 3 weeks of the study.
959917|NCT00928057|O2|Outcome|5 mm PN|All randomized subjects that used the 5mm PN, either during the first or second 3 weeks of the study.
959918|NCT00928057|O1|Outcome|4 mm PN|All randomized subjects that used the 4mm PN, either during the first or second 3 weeks of the study.
959919|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
959920|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
959921|NCT00928057|O2|Outcome|4 mm / 5 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
959922|NCT00928057|O1|Outcome|4 mm / 8 mm PN|use of one PN for insulin injections for 3 weeks, followed by 3 weeks with the alternate PN
959923|NCT00928057|E3|Reported Event|4mm PN|All randomized subjects that used the 4mm pen needle.
959924|NCT00928057|E2|Reported Event|5mm PN|All randomized subjects that used the 5 mm pen needle.
959925|NCT00928057|E1|Reported Event|8mm PN|All randomized subjects that used the 8 mm pen needle.
959926|NCT00928018|B3|Baseline|Total|Total of all reporting groups
959927|NCT00928018|B2|Baseline|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959928|NCT00928018|B1|Baseline|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959929|NCT00928018|P2|Participant Flow|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959930|NCT00928018|P1|Participant Flow|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959931|NCT00928018|O4|Outcome|Aggressive Group: Sirolimus-Free Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
959961|NCT00927953|P1|Participant Flow|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959962|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
959963|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959964|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
959965|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959966|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
959967|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959968|NCT00927953|O2|Outcome|Placebo - Normal Saline|single intravenous infusion of saline placebo
959969|NCT00927953|O1|Outcome|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959970|NCT00927953|O2|Outcome|Placebo-Normal Saline|single intravenous infusion of saline placebo
959932|NCT00928018|O3|Outcome|Aggressive Group: Sirolimus-Containing Regimen|"Aggressive group: aggressive B-cell NHL, MCL, and T-cell NHL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
959933|NCT00928018|O2|Outcome|Indolent Group: Sirolimus-Free Regimen|"Indolent group: indolent B-cell NHL, CLL and HL histologies~There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3. Taken orally or given intravenously for at least 6 months~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3. Taken orally for about 2 months."
959934|NCT00928018|O1|Outcome|Indolent Group: Sirolimus-Containing Regimen|"Indolent group:indolent B-cell NHL, CLL and HL histologies~The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.Taken orally or given intravenously for at least 6 months~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.Taken orally for at least 12 months~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.Given intravenously on the first, third and sixth day after transplant"
959935|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959936|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959937|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959938|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959939|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959940|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959941|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959942|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959943|NCT00928018|O2|Outcome|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959944|NCT00928018|O1|Outcome|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959945|NCT00928018|E2|Reported Event|Sirolimus-Free Regimen|"There are two choices for the Sirolimus free arm:~Control Arm 1: tacrolimus + methotrexate~Tacrolimus:Administered orally at dose of 0.05 mg/kg based on ABW bid starting on day -3.~Methotrexate:Administered by intravenous bolus infusion at dose of 5 mg/m2 on days +1, +3 and +6. For patients receiving stem cells from unrelated donors, an additional dose will be given on day +11.~Control Arm 2: cyclosporine + MMF~Cyclosporine: administered orally at dose of 6 mg/kg based on ABW bid starting on day -3.~MMF:administered at dose of 3gm daily orally (or intravenously if the patient cannot tolerate oral administration) divided in 2 or 3 doses (bid or tid) depending on physician preference starting day 3.~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months~Cyclosporine: Taken orally or given intravenously for at least 6 months~MMF: Taken orally for about 2 months"
959946|NCT00928018|E1|Reported Event|Sirolimus-Containing Regimen|"The Sirolimus containing arm will consist of the following drugs:~Experimental Arm: tacrolimus + sirolimus + low-dose methotrexate~Tacrolimus: Administered orally at a dose of 0.05 mg/kg based on ABW bid starting on day -3.~Sirolimus:Given as a loading oral dose of 12 mg on day -3, then as a daily maintenance dose of 4 mg starting on day -2.~Methotrexate: Administered by intravenous bolus infusion, per institutional standard, at a dose of 5 mg/m2 on days +1, +3 and +6.~Sirolimus: Taken orally for at least 12 months~Methotrexate: Given intravenously on the first, third and sixth day after transplant~Tacrolimus: Taken orally or given intravenously for at least 6 months"
959947|NCT00927992|B1|Baseline|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959948|NCT00927992|P1|Participant Flow|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959949|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959950|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959951|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959952|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959953|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959954|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959955|NCT00927992|O1|Outcome|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959956|NCT00927992|E1|Reported Event|Hemophiliac Participants With Liver Transplant|Participants with hemophilia (type A or B) who had undergone a liver transplant were observed for 3 months.
959957|NCT00927953|B3|Baseline|Total|Total of all reporting groups
959958|NCT00927953|B2|Baseline|Placebo - Normal Saline|single intravenous infusion of saline placebo
959959|NCT00927953|B1|Baseline|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959960|NCT00927953|P2|Participant Flow|Placebo - Normal Saline|single intravenous infusion of saline placebo
959972|NCT00927953|E2|Reported Event|Placebo - Normal Saline|single intravenous infusion of saline placebo
959973|NCT00927953|E1|Reported Event|MGAWN1|30 mg/kg single intravenous infusion of MGAWN1
959974|NCT00927940|B1|Baseline|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
959975|NCT00927940|P1|Participant Flow|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
959976|NCT00927940|O1|Outcome|Zotarolims Eluting Stent|
959977|NCT00927940|O1|Outcome|Zotarolimus Eluting Stent|100 lesion of 100 ITT patients were subjected for this analysis.
959978|NCT00927940|E1|Reported Event|Zotalolimus Eluting Sttent|All patients may have one or two lesions, if the two lesions are located in separate coronary arteries. A patient with one or two lesions treated with stents of diameter 2.5mm - 3.5mm will be designated in this study.
959979|NCT00927927|B16|Baseline|Total|Total of all reporting groups
959980|NCT00927927|B15|Baseline|MD Placebo|Subjects were injected biweekly four times with placebo
959981|NCT00927927|B14|Baseline|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
959982|NCT00927927|B13|Baseline|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
959983|NCT00927927|B12|Baseline|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
959984|NCT00927927|B11|Baseline|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
959985|NCT00927927|B10|Baseline|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
959986|NCT00927927|B9|Baseline|SD Placebo|Subjects were dosed once with placebo
959987|NCT00927927|B8|Baseline|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
959988|NCT00927927|B7|Baseline|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
959989|NCT00927927|B6|Baseline|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
959990|NCT00927927|B5|Baseline|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
959991|NCT00927927|B4|Baseline|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
959992|NCT00927927|B3|Baseline|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
959993|NCT00927927|B2|Baseline|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
959994|NCT00927927|B1|Baseline|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
959995|NCT00927927|P15|Participant Flow|MD Placebo|Subjects were injected biweekly four times with placebo
959996|NCT00927927|P14|Participant Flow|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
959997|NCT00927927|P13|Participant Flow|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
959998|NCT00927927|P12|Participant Flow|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
959999|NCT00927927|P11|Participant Flow|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
960000|NCT00927927|P10|Participant Flow|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
960001|NCT00927927|P9|Participant Flow|SD Placebo|Subjects were dosed once with placebo
960002|NCT00927927|P8|Participant Flow|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
960003|NCT00927927|P7|Participant Flow|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
960004|NCT00927927|P6|Participant Flow|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
960005|NCT00927927|P5|Participant Flow|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
960006|NCT00927927|P4|Participant Flow|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
960007|NCT00927927|P3|Participant Flow|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
960008|NCT00927927|P2|Participant Flow|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
960009|NCT00927927|P1|Participant Flow|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
960010|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
960011|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
960012|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
960013|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
960014|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
960015|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
960016|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
960017|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
960018|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
960019|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
960020|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
960021|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
960022|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
960023|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
960024|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
961723|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
960025|NCT00927927|O15|Outcome|MD Placebo|Subjects were injected biweekly four times with placebo
960026|NCT00927927|O14|Outcome|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
960027|NCT00927927|O13|Outcome|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
960028|NCT00927927|O12|Outcome|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
960029|NCT00927927|O11|Outcome|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
960030|NCT00927927|O10|Outcome|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
960031|NCT00927927|O9|Outcome|SD Placebo|Subjects were dosed once with placebo
960032|NCT00927927|O8|Outcome|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
960033|NCT00927927|O7|Outcome|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
960034|NCT00927927|O6|Outcome|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
960035|NCT00927927|O5|Outcome|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
960036|NCT00927927|O4|Outcome|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
960037|NCT00927927|O3|Outcome|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
960038|NCT00927927|O2|Outcome|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
960039|NCT00927927|O1|Outcome|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
960040|NCT00927927|E15|Reported Event|MD Placebo|Subjects were injected biweekly four times with placebo
960041|NCT00927927|E14|Reported Event|MD 4.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 4.0 mg/kg
960042|NCT00927927|E13|Reported Event|MD 1.6 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.6 mg/kg
960043|NCT00927927|E12|Reported Event|MD 1.0 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 1.0 mg/kg
960044|NCT00927927|E11|Reported Event|MD 0.3 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.3 mg/kg
960045|NCT00927927|E10|Reported Event|SD Placebo|Subjects were dosed once with placebo
960046|NCT00927927|E9|Reported Event|SD 7.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 7.5 mg/kg
960047|NCT00927927|E8|Reported Event|SD 2.5 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 2.5 mg/kg
960048|NCT00927927|E7|Reported Event|SD 0.7 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.7 mg/kg
960049|NCT00927927|E6|Reported Event|SD 0.175 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.175 mg/kg
960050|NCT00927927|E5|Reported Event|SD 0.035 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.035 mg/kg
960051|NCT00927927|E4|Reported Event|SD 0.007 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.007 mg/kg
960052|NCT00927927|E3|Reported Event|SD 0.0012 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0012 mg/kg
960053|NCT00927927|E2|Reported Event|MD 0.02 mg/kg|Subjects were injected biweekly four times with NNC0142-0002 at a dose of 0.02 mg/kg
960054|NCT00927927|E1|Reported Event|SD 0.0002 mg/kg|Subjects were dosed once with NNC0142-0002 at a dose of 0.0002 mg/kg
960055|NCT00927901|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received the 3 salt forms of indacaterol 400 µg (maleate, acetate, and xinafoate) and placebo to indacaterol in 4 different sequences. The dose refers to 400 μg of free base indacaterol. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960056|NCT00927901|P4|Participant Flow|Placebo-indacaterol (Ind) Acetate-ind Maleate-ind Xinafoate|In treatment period 1, patients received placebo to indacaterol; in treatment period 2, patients received indacaterol acetate 400 μg; in treatment period 3, patients received indacaterol maleate 400 μg; and in treatment period 4, patients received indacaterol xinafoate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960057|NCT00927901|P3|Participant Flow|Indacaterol (Ind) Acetate-ind Xinafoate-placebo-ind Maleate|In treatment period 1, patients received indacaterol acetate 400 μg; in treatment period 2, patients received indacaterol xinafoate 400 μg; in treatment period 3, patients received placebo to indacaterol; and in treatment period 4, patients received indacaterol maleate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960074|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960117|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
960058|NCT00927901|P2|Participant Flow|Indacaterol (Ind) Xinafoate-ind Maleate-ind Acetate-placebo|In treatment period 1, patients received indacaterol xinafoate 400 μg; in treatment period 2, patients received indacaterol maleate 400 μg; in treatment period 3, patients received indacaterol acetate 400 μg; and in treatment period 4, patients received placebo to indacaterol 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
961724|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
960059|NCT00927901|P1|Participant Flow|Indacaterol (Ind) Maleate-placebo-ind Xinafoate-ind Acetate|In treatment period 1, patients received indacaterol maleate 400 μg; in treatment period 2, patients received placebo to indacaterol; in treatment period 3, patients received indacaterol xinafoate 400 μg; and in treatment period 4, patients received indacaterol acetate 400 μg. Patients received each treatment for 7 days via the Concept1 single-dose dry-powder inhaler. There was a washout period of at least 7 days between each treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960060|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960061|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960062|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960063|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960064|NCT00927901|O2|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960065|NCT00927901|O1|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960066|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960067|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960068|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|3Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960069|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960070|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960071|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960072|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960073|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960118|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
960075|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960119|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
961100|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
960076|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960077|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960078|NCT00927901|O4|Outcome|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960079|NCT00927901|O3|Outcome|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960080|NCT00927901|O2|Outcome|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960081|NCT00927901|O1|Outcome|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960082|NCT00927901|E4|Reported Event|Placebo to Indacaterol|Patients received placebo to indacaterol once daily for 7 days via the Concept1 single-dose dry-powder inhaler. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960083|NCT00927901|E3|Reported Event|Indacaterol Xinafoate 400 μg|Patients received indacaterol xinafoate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960084|NCT00927901|E2|Reported Event|Indacaterol Maleate 400 μg|Patients received indacaterol maleate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960085|NCT00927901|E1|Reported Event|Indacaterol Acetate 400 μg|Patients received indacaterol acetate 400 μg once daily for 7 days via the Concept1 single-dose dry-powder inhaler. The dose refers to 400 μg of free base indacaterol. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
960086|NCT00927888|B3|Baseline|Total|Total of all reporting groups
960087|NCT00927888|B2|Baseline|Group 2 - Saline Placebo Group|Saline substituted in block, placebo treatment group with application of saline block before FESS.
960088|NCT00927888|B1|Baseline|Group 1 Bupivacaine|Active treatment group with application of bupivacaine block before FESS.
960089|NCT00927888|P2|Participant Flow|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
960090|NCT00927888|P1|Participant Flow|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
960091|NCT00927888|O2|Outcome|Group 2 - Placebo Saline Block|This group proceeded as per teh active treatment group but with blinded use of saline in the block syringe before start of FESS.
960092|NCT00927888|O1|Outcome|Group 1 - Bupivacaine Block|Active treatment group with application of bupivacaine block before FESS.
960093|NCT00927888|O2|Outcome|2 - Placebo|Normal saline with Epi 1:100,000 (B block)
960094|NCT00927888|O1|Outcome|1 - Bupivacaine Block|"3 ml of 0.25% Bupivacaine with Epi 1:100,000 (A block)~Bupivacaine Block: Bupivacaine local anesthesia block prior to start of FESS procedure."
960095|NCT00927888|E2|Reported Event|Group 2 - Saline Placebo Block|Placebo treatment group with application of saline block before FESS.
960096|NCT00927888|E1|Reported Event|Group 1 - Bupicaine Block|Active treatment group with application of bupivacaine block before FESS.
960097|NCT00927862|B3|Baseline|Total|Total of all reporting groups
960098|NCT00927862|B2|Baseline|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
960099|NCT00927862|B1|Baseline|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
960113|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
960114|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
960115|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
961696|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
960120|NCT00927862|E2|Reported Event|Historical Controls|A parallel, clinical effectiveness comparison group that used an algorithm with standard dosing
960121|NCT00927862|E1|Reported Event|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the pharmacogenetic (PG)-dosing algorithms (standard or modified IWPC warfarin algorithms)
960100|NCT00927862|P2|Participant Flow|Parellel/Historical Controls|A parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized pharmacogenetic-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified.
960101|NCT00927862|P1|Participant Flow|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms were randomized to receive either standard or modified International Warfarin Pharmacogenetics Consortium [IWPC] warfarin dosing. The IWPC derived and published a common algorithm to predict stable maintenance dose based on ~5000 patients across broad geographic and ethnic/racial groups (N Engl J Med 2009;360:753-764). Hence, we based our standard algorithm on the IWPC algorithm with minor modifications to accommodate different INR targets and smoking status, based on supplemental data from Gage et al (Clini Pharmacol Ther 2008;84:326 -331). The modified IWPC algorithm included 2 further modifications: (1) It ignored the CYP2C9 variant status for the first 2 days; and (2) It used a special dose-revision algorithm based on a day 4 (or day 5) INR after 3 (or 4) warfarin doses.
960102|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
960103|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
960104|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
960105|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
960106|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
960107|NCT00927862|O1|Outcome|Standard IWPC Warfarin Dosing Algorithm|Standard International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with minor modification
960108|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
960109|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
960110|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
960111|NCT00927862|O1|Outcome|PG Dosing Patients|Patients who were enrolled in CoumaGen-II and thus, received their warfarin dosing by the PG-dosing algorithms (standard or modified IWPC warfarin algorithms)
960112|NCT00927862|O2|Outcome|Parallel Controls|The parallel, standard-dosing patient control cohort was identified by a query of the electronic medical records databases of the 3 participating hospitals for the time interval spanning enrollment of the randomized PG-guided cohorts (July 2008 through December 2010). Patients >=18 years of age initiating warfarin therapy with a baseline and at least 1 follow-up INR level between days 3 and 14 were selected. Initial dose selection and therapy modification was at individual Intermountain-credentialed physician/healthcare provider discretion. Standard management is non-PG-based. A standard (fixed) initial maintenance dose of 5 mg/d is generally assumed, with loading doses and clinical-factor modifications not specified. However,the same standard INR-based dose-modification algorithm developed and promoted by Intermountain is generally recommended.
960116|NCT00927862|O2|Outcome|Modified IWPC Warfarin Dosing Algorithm|Modified International Warfarin Pharmacogenetics Consortium (IWPC) warfarin dosing algorithm with 3 modifications
960123|NCT00927849|B3|Baseline|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
960124|NCT00927849|B2|Baseline|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
960125|NCT00927849|B1|Baseline|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
960126|NCT00927849|P3|Participant Flow|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
960127|NCT00927849|P2|Participant Flow|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
960128|NCT00927849|P1|Participant Flow|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
960129|NCT00927849|O3|Outcome|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
960130|NCT00927849|O2|Outcome|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
960131|NCT00927849|O1|Outcome|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
960132|NCT00927849|E3|Reported Event|Botilinium Toxin Injection|All were injected with BTX- A in the left lateral position; anesthesia was not required. A volume of 0.5 ml of dissolved toxin, i.e., 100 u Dysport, is injected in each patient. The injection is given with an insulin syringe fitted with a needle size of 21 gauze and 3.75 lengths. Injection into the IAS, with the patients awake in the left -lateral position in the outpatient clinic in the 3 and 9 o'clock position.
960133|NCT00927849|E2|Reported Event|Glycein Trinitrate Group|(21) all were instructed to apply the GTN ointment 0.2 % twice a day to the edge and just inside the anal canal for 8 week course.
960134|NCT00927849|E1|Reported Event|Surgical Group Lateral Sphincterotomy|underwent closed lateral internal sphincterotomy under local anesthesia at 3 o'clock in lithotomy position reaching up to the dentate line.
960135|NCT00927823|B1|Baseline|Entire Study Population|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960136|NCT00927823|P4|Participant Flow|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960137|NCT00927823|P3|Participant Flow|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960138|NCT00927823|P2|Participant Flow|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960139|NCT00927823|P1|Participant Flow|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960140|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960141|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960142|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960255|NCT00927472|P1|Participant Flow|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
961697|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
960143|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960165|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960144|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960145|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960146|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960147|NCT00927823|O2|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960148|NCT00927823|O1|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960149|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960150|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960151|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960152|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960153|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960154|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960155|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960156|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960157|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960158|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960159|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960160|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960161|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960162|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960163|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960256|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960164|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960166|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960167|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960168|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960169|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960170|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960171|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960172|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960173|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 11 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
960174|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 8 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
960175|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 4 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
960176|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 milligram (mg) tablet in lead-in period (4 to 10 days prior to Day 1) followed by PF-04691502 2 mg tablet orally, once daily, continuously in 21-day cycles up to 1 year.
960177|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960178|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960179|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960180|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960181|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960182|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960183|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960184|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960185|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960257|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960186|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960187|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960188|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960189|NCT00927823|O1|Outcome|PF-04691502|All participants received either PF-04691502 2 mg, 4 mg, 8 mg or 11 mg tablet as a single oral dose in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by same PF-04691502 dose orally once daily continuously in 21 day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960190|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960191|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960192|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960193|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960194|NCT00927823|O4|Outcome|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960195|NCT00927823|O3|Outcome|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960196|NCT00927823|O2|Outcome|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960197|NCT00927823|O1|Outcome|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960198|NCT00927823|E4|Reported Event|PF-04691502 11 mg|Single oral dose of PF-04691502 11 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 11 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960199|NCT00927823|E3|Reported Event|PF-04691502 8 mg|Single oral dose of PF-04691502 8 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 8 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960200|NCT00927823|E2|Reported Event|PF-04691502 4 mg|Single oral dose of PF-04691502 4 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 4 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960201|NCT00927823|E1|Reported Event|PF-04691502 2 mg|Single oral dose of PF-04691502 2 mg tablet in lead-in period (4 to 10 days prior to Cycle 1 Day 1), followed by PF-04691502 2 mg tablet orally once daily continuously in 21-day cycles up to 1 year unless participants experienced disease progression or unacceptable toxicity or withdrew consent.
960202|NCT00927758|B1|Baseline|All Randomized Patients|Baseline measured for all randomized (safety set) patients.
960203|NCT00927758|P6|Participant Flow|Sequence 6: Flu/Sal- 100mcg/50mcg ->500mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
960204|NCT00927758|P5|Participant Flow|Sequence 5: Flu/Sal- 500mcg/50mcg ->100mcg/50mcg->250mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
960205|NCT00927758|P4|Participant Flow|Sequence 4: Flu/Sal- 250mcg/50mcg ->500mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
960548|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960206|NCT00927758|P3|Participant Flow|Sequence 3: Flu/Sal- 100mcg/50mcg ->250mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
960786|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960207|NCT00927758|P2|Participant Flow|Sequence 2: Flu/Sal- 500mcg/50mcg ->250mcg/50mcg->100mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
960208|NCT00927758|P1|Participant Flow|Sequence 1: Flu/Sal- 250mcg/50mcg ->100mcg/50mcg->500mcg/50mcg|"Treatment cycle 1: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for~7 days.~Treatement Cycle 2 : Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for~7 days.~Treatment Cycle 3: Patient randomized to Fluticasone~Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for~7 days.~There were 14 days washout period between cycles."
960209|NCT00927758|O3|Outcome|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
960210|NCT00927758|O2|Outcome|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
960211|NCT00927758|O1|Outcome|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
960212|NCT00927758|E3|Reported Event|Flu/Sal- 500mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 500mcg/50mcg once daily for 7 days.
960213|NCT00927758|E2|Reported Event|Flu/Sal- 250mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 250mcg/50mcg once daily for 7 days.
960214|NCT00927758|E1|Reported Event|Flu/Sal- 100mcg/50mcg|All randomized patients Fluticasone Propionate/Salmeterol (Flu/Sal) received 100mcg/50mcg once daily for 7 days.
960215|NCT00927589|B1|Baseline|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960216|NCT00927589|P1|Participant Flow|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 milligrams per kilogram (mg/kg) of body weight given by intravenous (IV) infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 milligrams per square meter (mg/m^2) of body surface area (BSA) on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target area under the concentration-versus-time curve (AUC) of 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960217|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960218|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960219|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960220|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960258|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960260|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960261|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960894|NCT00926029|E1|Reported Event|Placebo Control|fluoride toothpaste (Winterfresh Gel)
960221|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960222|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960223|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960224|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960225|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960226|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960227|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960228|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960229|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960230|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960259|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960231|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960232|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960233|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960234|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960235|NCT00927589|O1|Outcome|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960236|NCT00927589|E1|Reported Event|Trastuzumab + Docetaxel + Carboplatin|Trastuzumab was administered at an initial dose of 6 mg/kg of body weight given by IV infusion over 90 (±10) minutes on Cycle 1 Day 2 and Cycle 1 Day 8, followed by a maintenance dose of 6 mg/kg given by IV infusion on Day 1 of each subsequent treatment cycle (every 21 [±3] days). Docetaxel was administered as an IV dose of 75 mg/m^2 of BSA on Day 1 of each study treatment cycle. Carboplatin was administered as an IV dose at a target AUC of 6 mg/mL/min on Day 1 of each study treatment cycle. Study treatment continued until the Investigator decided to discontinue study therapy or for up to 12 months after the last participant was enrolled in the study, whichever came first.
960237|NCT00927576|B3|Baseline|Total|Total of all reporting groups
960238|NCT00927576|B2|Baseline|TBI Patients|TBI patients N = 30. Mixed mild and severe TBI group, with most showing PTSD comorbidity.
960239|NCT00927576|B1|Baseline|Control Subjects|Control subjects = 230. Normal control subjects of various ages.
960240|NCT00927576|P2|Participant Flow|TBI Patients|TBI patients N = 28. These patients underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
960241|NCT00927576|P1|Participant Flow|Control Subjects|Control subjects = 237. These subjects underwent extensive testing with computerized neuropsychological tests including digit span testing, spatial span testing, simple reaction time testing, choice reaction time testing, finger tapping, verbal fluency, design fluency, verbal list learning, questionnaire completion, and the trail making test.
960242|NCT00927576|O1|Outcome|Simple Reaction Time Test|time to respond in ms to visual stimuli presented randomly to the left or right hemifield at varying stimulus onset asynchronies.
960243|NCT00927576|E2|Reported Event|TBI Patients|TBI patients N = 28. No adverse events were observed
960244|NCT00927576|E1|Reported Event|Control Subjects|Control subjects = 237. No adverse events were observed.
960245|NCT00927563|B1|Baseline|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
960246|NCT00927563|P1|Participant Flow|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
960247|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
960248|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
960249|NCT00927563|O1|Outcome|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
960250|NCT00927563|E1|Reported Event|Tolcapone|"Tolcapone 100-300mg/day~Tolcapone : pill, 100-300mg/day for 8 weeks"
960251|NCT00927472|B3|Baseline|Total|Total of all reporting groups
960252|NCT00927472|B2|Baseline|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960253|NCT00927472|B1|Baseline|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960254|NCT00927472|P2|Participant Flow|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960262|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960263|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960264|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960265|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960266|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960267|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960268|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960269|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960270|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960271|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960272|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960273|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960274|NCT00927472|O2|Outcome|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960275|NCT00927472|O1|Outcome|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960276|NCT00927472|E2|Reported Event|Nix Creme Rinse|"Nix applied to scalp for 10 minutes~Permethrin 1% rinse: Permethrin 1% shampooed into scalp for 10 minutes. May be repeated in 1 week if head lice are still present."
960277|NCT00927472|E1|Reported Event|Malathion Gel|"Malathion gel 0.5% 30 minute application~Malathion gel 0.5%: Malathion gel 0.5% applied to scalp for 30 minutes. May be repeated in 1 week if head lice are still present."
960278|NCT00927394|B3|Baseline|Total|Total of all reporting groups
960279|NCT00927394|B2|Baseline|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960280|NCT00927394|B1|Baseline|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960281|NCT00927394|P2|Participant Flow|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960282|NCT00927394|P1|Participant Flow|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960283|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960284|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960285|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960286|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960287|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960288|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960289|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960290|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960291|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960292|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960293|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960294|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960295|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960296|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960297|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960298|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960299|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960300|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960301|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
961698|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
960302|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960303|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960304|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960305|NCT00927394|O2|Outcome|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960306|NCT00927394|O1|Outcome|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks
960307|NCT00927394|E2|Reported Event|Monotherapy: Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day) for 8 weeks. 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 2 weeks. Forced titrated to: 2 capsules of Valsartan 160 mg + 2 tablets of placebo Aliskiren 150 mg daily for 6 weeks.
960308|NCT00927394|E1|Reported Event|Combination Therapy: Aliskiren + Valsartan|To adequately blind the study, patients were required to take a total of 4 tablets/capsules a day (2 tablets and 2 capsules of study drug per day)for 8 weeks. 1 tablet of Aliskiren 150 mg + 1 tablet of placebo Aliskiren 150 mg + 1 capsule of Valsartan 160 mg + 1 capsule of placebo Valsartan 160 mg daily for 2 weeks. Forced titrated to: 2 tablets of Aliskiren 150 mg + 2 capsules of Valsartan 160 mg daily for 6 weeks.
960309|NCT00927368|B4|Baseline|Total|Total of all reporting groups
960310|NCT00927368|B3|Baseline|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
960311|NCT00927368|B2|Baseline|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
960312|NCT00927368|B1|Baseline|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
960313|NCT00927368|P3|Participant Flow|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
960314|NCT00927368|P2|Participant Flow|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
960886|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/zinc toothpaste
960349|NCT00927355|O1|Outcome|Pioglitazone-Osteoblast CFU (Colony Forming Units)|Percent change in Osteoblast CFU numbers as stained with Alizarin red S at baseline and 6 months after treatment with study drug.
960350|NCT00927355|E2|Reported Event|Placebo|The other half will be randomized to placebo.
960351|NCT00927355|E1|Reported Event|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
960315|NCT00927368|P1|Participant Flow|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
960316|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
960317|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
960318|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
960319|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
960320|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
960321|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
960322|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
960323|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
960324|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
960887|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
960325|NCT00927368|O3|Outcome|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
960326|NCT00927368|O2|Outcome|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
960327|NCT00927368|O1|Outcome|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
960328|NCT00927368|E3|Reported Event|Ultrasound Guidance+Catheter Stimulation|For the ultrasound guidance and catheter stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA. At that point, the peripheral nerve stimulator was then disconnected from the stimulating needle and connected to the proximal end of the catheter. The catheter was then advanced 5 cm past the needle tip. If the motor response disappeared during catheter advancement, the catheter was withdrawn slightly until the response returned. Needle orientation and catheter advancement were adjusted as necessary to elicit quadriceps contractions via the catheter with a stimulating current ≤0.5 mA.
960329|NCT00927368|E2|Reported Event|Ultrasound Guidance Needle Stimulation|"For the ultrasound guidance and needle stimulation arm, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation~ultrasound guidance and needle stimulation: For the ultrasound guidance and needle stimulation group, the Tuohy needle was positioned with the tip beneath the fascia iliaca under ultrasound guidance. The needle tip was then adjusted as necessary to obtain a quadriceps muscle response with a stimulating current ≤0.5 mA (2 Hz, pulse width 0.1 msec). Subsequently, the catheter was threaded 5 cm beyond the needle tip without additional electrical stimulation."
960330|NCT00927368|E1|Reported Event|Ultrasound Guidance Alone|"The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used.~ultrasound guidance alone: The Tuohy needle was inserted in out-plane approach. Needle placement was considered adequate when the tip was visualized beneath the fascia iliaca; the catheter was then introduced 5 cm beyond the needle tip. Electrical stimulation was not used."
960331|NCT00927355|B3|Baseline|Total|Total of all reporting groups
960332|NCT00927355|B2|Baseline|Placebo|The other half will be randomized to placebo.
960333|NCT00927355|B1|Baseline|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
960334|NCT00927355|P2|Participant Flow|Placebo|The other half will be randomized to placebo, starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
960335|NCT00927355|P1|Participant Flow|Pioglitazone|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months starting out with 15mg qday for 4 weeks and if no adverse effects noted increased to 30mg qday for 5 more months.
960336|NCT00927355|O4|Outcome|Placebo - Lumbar Spine BMD|The other half will be randomized to placebo.
960337|NCT00927355|O3|Outcome|Pioglitazone -Lumbar Spine BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
960338|NCT00927355|O2|Outcome|Placebo-Femoral Neck BMD|The other half will be randomized to placebo.
960339|NCT00927355|O1|Outcome|Pioglitazone-Femoral Neck BMD|half of the diabetic patients will be randomized to pioglitazone treatment for 6 months.
960340|NCT00927355|O6|Outcome|Placebo - Osc|serum Osteocalcin percent change 6 mo after placebo Rx compared to baseline.
960341|NCT00927355|O5|Outcome|Pioglitazone-OSc|serum Osteocalcin percent change 6 mo after pioglitazone Rx compared to baseline.
960342|NCT00927355|O4|Outcome|Placebo-CTX|serum CTX percent change 6 mo after placebo Rx compared to baseline.
960343|NCT00927355|O3|Outcome|Pioglitazone-CTX|serum CTX percent change 6 mo after pioglitazone Rx compared to baseline.
960344|NCT00927355|O2|Outcome|Placebo-Adiponectin|serum adiponectin percent change 6 mo after placebo Rx compared to baseline.
960345|NCT00927355|O1|Outcome|Pioglitazone-Adiponectin|serum adiponectin percent change 6 mo after study drug Rx compared to baseline.
960346|NCT00927355|O4|Outcome|Placebo-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O, at baseline and 6 months after treatment with study drug.
960347|NCT00927355|O3|Outcome|Pioglitazone-Adipocyte CFU|Percent change in adipocyte CFU numbers as stained with Oil red O at baseline and 6 months after treatment with study drug.
960348|NCT00927355|O2|Outcome|Placebo-OSteoblast CFU|Percent change in Osteoblast CFU numbers as stained with Alizarin at baseline and 6 months after treatment with study drug.
960888|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste
960352|NCT00927251|B1|Baseline|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
960353|NCT00927251|P1|Participant Flow|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
960354|NCT00927251|O1|Outcome|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
960355|NCT00927251|E1|Reported Event|Model 4296 LV Lead Study|This study is a prospective, multi-center, non-randomized, one-arm clinical trial using Objective Performance Criteria (OPC) to evaluate the safety and efficacy of the Model 4296 LV lead. The OPC based trial design is consistent with the designs used to evaluate all current market released Medtronic left ventricular leads. The Model 4296 LV lead is designed to provide physicians with acceptable unipolar pacing from two selectable electrodes.All subjects are planned to undergo a CRT system implant and will be followed through at least pre-hospital discharge and one month visit.
960356|NCT00927186|B3|Baseline|Total|Total of all reporting groups
960357|NCT00927186|B2|Baseline|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960358|NCT00927186|B1|Baseline|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960359|NCT00927186|P2|Participant Flow|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960360|NCT00927186|P1|Participant Flow|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960361|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960362|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960363|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960364|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960365|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960366|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960367|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960368|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960369|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960370|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960371|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960550|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960372|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960373|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960374|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960375|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960376|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960377|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960378|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960379|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960380|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960381|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960382|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960383|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960384|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960385|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960386|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960387|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960388|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960389|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960390|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960391|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960392|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960393|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960394|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960395|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960396|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960397|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960398|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960399|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960400|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960401|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960402|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960403|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960404|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960405|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960406|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960407|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960408|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960409|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960410|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960411|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960412|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960413|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960414|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960415|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960416|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960417|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960418|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960419|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960420|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960421|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960422|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960423|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960424|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960425|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960426|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960427|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension"
960428|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960429|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960430|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960431|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960432|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960433|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960434|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960435|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960436|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960437|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960438|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960439|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960440|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960441|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960442|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960443|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960444|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960445|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960446|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960447|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960448|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960449|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960450|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960451|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960452|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960453|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960454|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960455|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960456|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960457|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960458|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960459|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960460|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960461|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960462|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960463|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960464|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960465|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960466|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960467|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960468|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960469|NCT00927186|O2|Outcome|Zoledronic Acid|"5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960470|NCT00927186|O1|Outcome|Teriparatide|"20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind.~After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension."
960471|NCT00927186|O2|Outcome|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960472|NCT00927186|O1|Outcome|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960473|NCT00927186|E2|Reported Event|Zoledronic Acid|5 milligram (mg) intravenous (IV) infusion administered once during 1 year study. Placebo subcutaneous (SC) injections were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960474|NCT00927186|E1|Reported Event|Teriparatide|20 microgram (mcg) subcutaneous (SC) injection per day for 12 months. Placebo intravenous (IV) infusions were given to maintain blind. After completing 12 months of treatment, all participants are eligible to participate in an additional 12-month extension.
960475|NCT00927160|B3|Baseline|Total|Total of all reporting groups
960476|NCT00927160|B2|Baseline|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
960477|NCT00927160|B1|Baseline|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
960478|NCT00927160|P2|Participant Flow|Usual Care Group|Elderly patients admitted to the general medicine service in the hospital
960479|NCT00927160|P1|Participant Flow|MACE Group|Elderly patients admitted to the Mobile Acute Care of the Elderly Unit.
960480|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
960481|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
960482|NCT00927160|O2|Outcome|Usual Care|Matching group of patients admitted to general medical service
960483|NCT00927160|O1|Outcome|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
960484|NCT00927160|E2|Reported Event|Usual Care|Matching group of patients admitted to general medical service
960485|NCT00927160|E1|Reported Event|Mobile ACE|Patients admitted to the Mobile Acute Care of the Elderly Service
960486|NCT00927095|B4|Baseline|Total|Total of all reporting groups
960487|NCT00927095|B3|Baseline|Continuous Placebo|"continuous placebo~placebo: daily"
960488|NCT00927095|B2|Baseline|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
960489|NCT00927095|B1|Baseline|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
960490|NCT00927095|P3|Participant Flow|Continuous Placebo|"continuous placebo~placebo: daily"
960491|NCT00927095|P2|Participant Flow|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
960492|NCT00927095|P1|Participant Flow|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
960493|NCT00927095|O3|Outcome|Continuous Placebo|"continuous placebo~placebo: daily"
960494|NCT00927095|O2|Outcome|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
960495|NCT00927095|O1|Outcome|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
960496|NCT00927095|E3|Reported Event|Continuous Placebo|"continuous placebo~placebo: daily"
960497|NCT00927095|E2|Reported Event|Interrupted Low Dose Oral Contraceptive (21/7 Platform)|"interrupted low dose oral contraceptive (21/7 platform)~20 ug ethinyl estradiol + 3 mg drospirenone: daily for 21 days each month"
960498|NCT00927095|E1|Reported Event|Continuous Low Dose Oral Contraceptive|"continuous low dose oral contraceptive~low dose oral contraceptive (20 ug ethinyl estradiol + 3 mg drospirenone): daily for three months"
960499|NCT00927082|B5|Baseline|Total|Total of all reporting groups
960500|NCT00927082|B4|Baseline|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960501|NCT00927082|B3|Baseline|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960502|NCT00927082|B2|Baseline|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960503|NCT00927082|B1|Baseline|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960504|NCT00927082|P4|Participant Flow|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960505|NCT00927082|P3|Participant Flow|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
961699|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
960506|NCT00927082|P2|Participant Flow|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960681|NCT00926536|E1|Reported Event|C-arm CT + DSA as Needed|C-arm CT used for the purposes of navigation, supplemented by DSA if needed
960507|NCT00927082|P1|Participant Flow|PEG-IFN 90mcg 24 Wks|Participants received Pegasys (Pegylated interferon alfa-2a [PEG-IFN]) 90 micrograms (mcg) subcutaneously (SC) once a week for 24 weeks in Study WV19432 and entered follow-up (FU) Study MV22430.
960508|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960509|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960510|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960511|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960512|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960513|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960514|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960515|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960516|NCT00927082|O4|Outcome|Group D|Participants received 180 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960517|NCT00927082|O3|Outcome|Group C|Participants received 90 mcg PEG-IFN SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960518|NCT00927082|O2|Outcome|Group B|Participants received 180 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960519|NCT00927082|O1|Outcome|Group A|Participants received 90 mcg PEG-IFN SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960520|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960521|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960522|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960523|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960524|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960525|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960526|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960527|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960528|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960529|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960530|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960531|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960532|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960533|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960534|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960535|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960536|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960537|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960538|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960539|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960540|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960541|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960542|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960543|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960544|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960545|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960546|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960547|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960549|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960551|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960552|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960553|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960554|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960555|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960556|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960557|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960558|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960559|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960560|NCT00927082|O4|Outcome|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960561|NCT00927082|O3|Outcome|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960562|NCT00927082|O2|Outcome|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960563|NCT00927082|O1|Outcome|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960564|NCT00927082|E4|Reported Event|PEG-IFN 180mcg 48 Wks|Participants received PEG-IFN 180 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960565|NCT00927082|E3|Reported Event|PEG-IFN 90mcg 48 Wks|Participants received PEG-IFN 90 mcg SC once a week for 48 weeks in Study WV19432 and entered FU Study MV22430.
960566|NCT00927082|E2|Reported Event|PEG-IFN 180mcg 24 Wks|Participants received PEG-IFN 180 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960567|NCT00927082|E1|Reported Event|PEG-IFN 90mcg 24 Wks|Participants received PEG-IFN 90 mcg SC once a week for 24 weeks in Study WV19432 and entered FU Study MV22430.
960568|NCT00927069|B3|Baseline|Total|Total of all reporting groups
960569|NCT00927069|B2|Baseline|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
960570|NCT00927069|B1|Baseline|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
960571|NCT00927069|P4|Participant Flow|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
960572|NCT00927069|P3|Participant Flow|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
960573|NCT00927069|P2|Participant Flow|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
960574|NCT00927069|P1|Participant Flow|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
960575|NCT00927069|O2|Outcome|Group B|Patients at screening had shown a satisfactory response to etanercept 50mg twice a week followed by a loss of response after dose reduction to 50mg etanercept once a week.
960576|NCT00927069|O1|Outcome|Group A|Patients at screening had shown an unsastifactory response after 3 months of etanercept 50mg twice a week.
960577|NCT00927069|O1|Outcome|Groupe A Dose Increase at Week 12|Patients in group A who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
960578|NCT00927069|O1|Outcome|Groupe B Dose Increase at Week 12|Patients in group B who - after 12 weeks of adalimimab 40 mg every other week in this study - failed to acheive a PGA of clear or almost clear and had a dose increase to 40 mg adalimimab every week for another 12 weeks.
960579|NCT00927069|O1|Outcome|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept wihout dose reduction prior to screening.
960580|NCT00927069|O1|Outcome|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
960581|NCT00927069|E2|Reported Event|Group B|Patients who showed a satisfactory response to 3 months or more of etanercept 50 mg twice a week followed by a loss of response after dose reduction to 50 mg etanercept once a week prior to screening.
960582|NCT00927069|E1|Reported Event|Group A|Patients who have shown an unsatisfactory response to 3 months of etanercept 50 mg twice a week without dose reduction prior to screening.
960583|NCT00926952|B1|Baseline|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960584|NCT00926952|P1|Participant Flow|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960585|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960586|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960682|NCT00926497|B3|Baseline|Total|Total of all reporting groups
960587|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960588|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960589|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960590|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960591|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960592|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960593|NCT00926952|O1|Outcome|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960594|NCT00926952|E1|Reported Event|MAL-PDT 90 Min Incubation, no Occlusion|Patients have 2-4 g of Methylaminolevulinate (MAL) spread on the entire face without occlusion and wait 90 minutes prior to photodynamic therapy (PDT) using red light.
960595|NCT00926887|B3|Baseline|Total|Total of all reporting groups
960596|NCT00926887|B2|Baseline|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
960597|NCT00926887|B1|Baseline|Placebo Laser|inactive light
960598|NCT00926887|P2|Participant Flow|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
960599|NCT00926887|P1|Participant Flow|Placebo Laser|inactive light
960600|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
960601|NCT00926887|O1|Outcome|Placebo Laser|inactive light
960602|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
960603|NCT00926887|O1|Outcome|Placebo Laser|inactive light
960604|NCT00926887|O2|Outcome|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
960605|NCT00926887|O1|Outcome|Placebo Laser|inactive light
960606|NCT00926887|E2|Reported Event|Erchonia(R) EML Laser|The Erchonia(R) EML Laser uses two 7mw red 635nm wavelength light emitting CSRH Class IIIb laser diodes. The energy delivered is 1.5 J/cm2.
960607|NCT00926887|E1|Reported Event|Placebo Laser|inactive light
960608|NCT00926796|B3|Baseline|Total|Total of all reporting groups
960609|NCT00926796|B2|Baseline|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960610|NCT00926796|B1|Baseline|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960611|NCT00926796|P2|Participant Flow|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960612|NCT00926796|P1|Participant Flow|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960613|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960614|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960615|NCT00926796|O1|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960616|NCT00926796|O1|Outcome|Baseline|All per protocol participants at baseline with evaluable isolates
960617|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960618|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960619|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960620|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960621|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960622|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960623|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960624|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960625|NCT00926796|O2|Outcome|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960895|NCT00925990|B3|Baseline|Total|Total of all reporting groups
960626|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960627|NCT00926796|O1|Outcome|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960628|NCT00926796|E2|Reported Event|Regimen B: Gemifloxacin Plus Azithromycin|Gemifloxacin 320 mg by mouth one time plus azithromycin 2 gm by mouth one time.
960629|NCT00926796|E1|Reported Event|Regimen A: Gentamicin Plus Azithromycin|Gentamicin 240 mg intramuscular (IM) one time for patients greater than 45 kg or 5 mg/kg IM one time for patients less than or equal to 45 kg plus azithromycin 2 gm by mouth one time.
960630|NCT00926783|B3|Baseline|Total|Total of all reporting groups
960631|NCT00926783|B2|Baseline|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960632|NCT00926783|B1|Baseline|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960633|NCT00926783|P2|Participant Flow|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960634|NCT00926783|P1|Participant Flow|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960635|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960636|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960637|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960638|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960639|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960640|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960641|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960642|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960677|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
960678|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
960679|NCT00926536|O1|Outcome|C-arm CT +DSA as Needed|C-arm CT images used for navigational purposes supplemented by DSA if needed
960683|NCT00926497|B2|Baseline|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
960643|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960644|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960645|NCT00926783|O2|Outcome|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960646|NCT00926783|O1|Outcome|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960647|NCT00926783|E2|Reported Event|Generalized CFAE Ablation|Generalized complex fractionated atrial electrograms (CFAE) ablation focused on all repetitive CAFE, which was defined as interval confidence level (ICL) > 5. In the Generalized arm, the cardiac mapping system collects the abnormal electrical heart signals and displays in a specific color when the number of electrical signals are more than the specified number over a pre-specified length of time.
960648|NCT00926783|E1|Reported Event|Targeted CFAE Ablation|Targeted complex fractionated atrial electrograms (CFAE) ablation focuses on highly selective regions of continuous electrical activity (CEA) that are critical to Atrial Fibrillation (AF) perpetuation. In the Targeted arm, the cardiac mapping system collects the abnormal electrical heart signals that are displayed in another specific color when the abnormal electrical signal is above the normal for more than the specified percentage of time over a pre-specified length of time.
960649|NCT00926588|B3|Baseline|Total|Total of all reporting groups
960650|NCT00926588|B2|Baseline|Usual Care|Patients receive usual care for pain from their primary care physician
960651|NCT00926588|B1|Baseline|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
960652|NCT00926588|P2|Participant Flow|Usual Care|Patients receive usual care for pain from their primary care physician
960653|NCT00926588|P1|Participant Flow|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
960654|NCT00926588|O2|Outcome|Usual Care|Patients receive usual care for pain from their primary care physician
960655|NCT00926588|O1|Outcome|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
960656|NCT00926588|E2|Reported Event|Usual Care|Patients receive usual care for pain from their primary care physician
960657|NCT00926588|E1|Reported Event|Stepped Care|"Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used.~Stepped care: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study."
960658|NCT00926575|B3|Baseline|Total|Total of all reporting groups
960659|NCT00926575|B2|Baseline|Placebo|
960660|NCT00926575|B1|Baseline|Active|oral beclomethasone 17,21-dipropionate (BDP)
960661|NCT00926575|P2|Participant Flow|Placebo|
960662|NCT00926575|P1|Participant Flow|Active|oral beclomethasone 17,21-dipropionate (BDP)
960663|NCT00926575|O2|Outcome|Placebo|
960664|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
960665|NCT00926575|O2|Outcome|Placebo|
960666|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
960667|NCT00926575|O2|Outcome|Placebo|
960668|NCT00926575|O1|Outcome|Active|oral beclomethasone 17,21-dipropionate (BDP)
960669|NCT00926575|E2|Reported Event|Placebo|
960670|NCT00926575|E1|Reported Event|Active|oral beclomethasone 17,21-dipropionate (BDP)
960671|NCT00926536|B3|Baseline|Total|Total of all reporting groups
960672|NCT00926536|B2|Baseline|DSA Only|DSA images only used for vessel navigation and tracking
960673|NCT00926536|B1|Baseline|C-arm CT + DSA as Needed|C-arm CT in imaging guidance of TACE supplemented by DSA as needed for vessel navigation and tracking
960674|NCT00926536|P2|Participant Flow|DSA Only|Only Digital subtraction images used for vessel tracking and tumor navigation
960675|NCT00926536|P1|Participant Flow|C-arm CT +DSA as Needed|C-arm CT in imaging guidance of TACE supplemented with DSA as needed for vessel tracking and navigation
960676|NCT00926536|O2|Outcome|DSA Only|Only DSA imaging used for navigational purposes
960684|NCT00926497|B1|Baseline|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
960685|NCT00926497|P2|Participant Flow|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
960686|NCT00926497|P1|Participant Flow|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
960687|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
960688|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
960689|NCT00926497|O2|Outcome|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
960690|NCT00926497|O1|Outcome|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
960691|NCT00926497|E2|Reported Event|Standard Group|Standard treatment for suspected neonatal early-onset sepsis based on conventional laboratory parameters
960692|NCT00926497|E1|Reported Event|Procalcitonin-group|Antibiotic therapy is discontinued when two consecutive PCT values are below predefined age-adjusted cut-off values.Antibiotic therapy could be prolonged despite fulfilled PCT criteria at the discretion of the attending physician.
960693|NCT00926393|B3|Baseline|Total|Total of all reporting groups
960694|NCT00926393|B2|Baseline|Quetiapine XR|Quetiapine fumarate Extended Release
960695|NCT00926393|B1|Baseline|Quetiapine IR|Quetiapine fumarate Immediate Release
960696|NCT00926393|P2|Participant Flow|Quetiapine XR|Quetiapine fumarate Extended Release
960697|NCT00926393|P1|Participant Flow|Quetiapine IR|Quetiapine fumarate Immediate Release
960698|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960699|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960700|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960701|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960702|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960703|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960704|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960705|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960706|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960707|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960708|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960709|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960710|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960711|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960712|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960713|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960714|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960715|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960716|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960717|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960718|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960719|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960720|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960721|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960722|NCT00926393|O2|Outcome|Quetiapine XR|Quetiapine fumarate Extended Release
960723|NCT00926393|O1|Outcome|Quetiapine IR|Quetiapine fumarate Immediate Release
960724|NCT00926393|E2|Reported Event|Quetiapine XR|Quetiapine fumarate Extended Release
960725|NCT00926393|E1|Reported Event|Quetiapine IR|Quetiapine fumarate Immediate Release
960726|NCT00926367|B3|Baseline|Total|Total of all reporting groups
960727|NCT00926367|B2|Baseline|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960728|NCT00926367|B1|Baseline|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960729|NCT00926367|P2|Participant Flow|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960730|NCT00926367|P1|Participant Flow|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960731|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960732|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960733|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960734|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960735|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960736|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960737|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
961725|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
960738|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960739|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960740|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960741|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960742|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960743|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960744|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960745|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960746|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960747|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960748|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960749|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960750|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960751|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960752|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960753|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960754|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960755|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960756|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960757|NCT00926367|O2|Outcome|Epiduo|Patients Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960758|NCT00926367|O1|Outcome|Duac|Patients Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960759|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960760|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960761|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960762|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960763|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960764|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960765|NCT00926367|O2|Outcome|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960766|NCT00926367|O1|Outcome|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960767|NCT00926367|E2|Reported Event|Epiduo|Once-daily applications, to the randomized side of the face either left or right, of benzoyl peroxide and adapalene
960768|NCT00926367|E1|Reported Event|Duac|Once-daily applications, to the randomized side of the face either left or right, of a topical antibiotic and benzoyl peroxide
960769|NCT00926328|B3|Baseline|Total|Total of all reporting groups
960770|NCT00926328|B2|Baseline|Placebo Control|sodium fluoride toothpaste
960771|NCT00926328|B1|Baseline|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
960772|NCT00926328|P2|Participant Flow|Placebo Control|sodium fluoride toothpaste
960773|NCT00926328|P1|Participant Flow|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
960774|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
960775|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
960776|NCT00926328|O2|Outcome|Placebo Control|sodium fluoride toothpaste
960777|NCT00926328|O1|Outcome|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
960778|NCT00926328|E2|Reported Event|Placebo Control|sodium fluoride toothpaste
960779|NCT00926328|E1|Reported Event|Experimental Treatment|triclosan/copolymer/fluoride toothpaste
960780|NCT00926289|B3|Baseline|Total|Total of all reporting groups
960781|NCT00926289|B2|Baseline|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960782|NCT00926289|B1|Baseline|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960783|NCT00926289|P2|Participant Flow|Telmisartan 40/80 mg + HCTZ (Hydrochlorothiazide) 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960784|NCT00926289|P1|Participant Flow|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960785|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960787|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960788|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960789|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960790|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960791|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960792|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960793|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960794|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960795|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960796|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960797|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960798|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960799|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960800|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960801|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960802|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960803|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960804|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960805|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960806|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960807|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960808|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960809|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960810|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960811|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960812|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960813|NCT00926289|O2|Outcome|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960814|NCT00926289|O1|Outcome|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960815|NCT00926289|E2|Reported Event|Telmisartan 40/80 mg + HCTZ 12.5/25 mg|fixed combination of Telmisartan 40mg and HCTZ 12.5 mg once daily for 1 week with forced titration to T80+HCTZ25 for 6 weeks
960816|NCT00926289|E1|Reported Event|Telmisartan 40/80 mg|Telmisartan 40mg once daily for 1 week with forced titration to 80 mg for 6 weeks
960817|NCT00926263|B3|Baseline|Total|Total of all reporting groups
960818|NCT00926263|B2|Baseline|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960819|NCT00926263|B1|Baseline|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960820|NCT00926263|P2|Participant Flow|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960821|NCT00926263|P1|Participant Flow|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960822|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960823|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960824|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960825|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960826|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
961700|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
960827|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960828|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960829|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960830|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960831|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960832|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960833|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960834|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960835|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960836|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960837|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960838|NCT00926263|O1|Outcome|CP-751,871 20/20 mg/kg|Participants not enrolled due to early termination of the study.
960839|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960840|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960841|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960842|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960843|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960844|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960845|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960846|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960847|NCT00926263|O2|Outcome|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960848|NCT00926263|O1|Outcome|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960849|NCT00926263|E2|Reported Event|CP-751,871 20 mg/kg|A single dose of CP-751,871 at 20 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960850|NCT00926263|E1|Reported Event|CP-751,871 10 mg/kg|A single dose of CP-751,871 at 10 mg/kg following an 8 hour fast, administered via 1-hour IV infusion.
960851|NCT00926211|B1|Baseline|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
960852|NCT00926211|P1|Participant Flow|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
960853|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
960854|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
960855|NCT00926211|O2|Outcome|Computer-Assisted Harvest|Region of scalp with implanted follicles that were harvested using a computer-assisted system.
960856|NCT00926211|O1|Outcome|Manual Harvest|Region of scalp with implanted follicles that were manually harvested.
960857|NCT00926211|E1|Reported Event|Computer-Assisted and Manual Harvest|Each subject has a region of their scalp randomly assigned to be harvested by each method, the computer-assisted system or manual.
960858|NCT00926185|B5|Baseline|Total|Total of all reporting groups
960859|NCT00926185|B4|Baseline|Placebo|
960860|NCT00926185|B3|Baseline|Lifitegrast 5.0%|
960861|NCT00926185|B2|Baseline|Lifitegrast 1.0%|
960862|NCT00926185|B1|Baseline|Lifitegrast 0.1%|
960863|NCT00926185|P4|Participant Flow|Placebo|
960864|NCT00926185|P3|Participant Flow|Lifitegrast 5.0%|
960865|NCT00926185|P2|Participant Flow|Lifitegrast 1.0%|
960866|NCT00926185|P1|Participant Flow|Lifitegrast 0.1%|
960867|NCT00926185|O4|Outcome|Placebo|
960868|NCT00926185|O3|Outcome|Lifitegrast 5.0%|
960869|NCT00926185|O2|Outcome|Lifitegrast 1.0%|
960870|NCT00926185|O1|Outcome|Lifitegrast 0.1%|
960871|NCT00926185|O4|Outcome|Placebo|
960872|NCT00926185|O3|Outcome|Lifitegrast 5.0%|
960873|NCT00926185|O2|Outcome|Lifitegrast 1.0%|
960874|NCT00926185|O1|Outcome|Lifitegrast 0.1%|
960875|NCT00926185|E4|Reported Event|Placebo|
960876|NCT00926185|E3|Reported Event|Lifitegrast 5.0%|
960877|NCT00926185|E2|Reported Event|Lifitegrast 1.0%|
960878|NCT00926185|E1|Reported Event|Lifitegrast 0.1%|
960879|NCT00926029|B4|Baseline|Total|Total of all reporting groups
960880|NCT00926029|B3|Baseline|Experimental|triclosan/fluoride/zinc toothpaste
960881|NCT00926029|B2|Baseline|Positive Control|triclosan/fluoride toothpaste
960882|NCT00926029|B1|Baseline|Placebo Control|fluoride toothpaste
960883|NCT00926029|P3|Participant Flow|Experimental|triclosan/fluoride/metal salt toothpaste
960884|NCT00926029|P2|Participant Flow|Positive Control|triclosan/fluoride toothpaste
960885|NCT00926029|P1|Participant Flow|Placebo Control|fluoride toothpaste (Winterfresh Gel)
960889|NCT00926029|O3|Outcome|Experimental|triclosan/fluoride/metal salt toothpaste
960890|NCT00926029|O2|Outcome|Positive Control|triclosan/fluoride toothpaste
960891|NCT00926029|O1|Outcome|Placebo Control|fluoride toothpaste (Winterfresh Gel)
960892|NCT00926029|E3|Reported Event|Experimental|triclosan/fluoride/metal salt toothpaste
960893|NCT00926029|E2|Reported Event|Positive Control|triclosan/fluoride toothpaste
960896|NCT00925990|B2|Baseline|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
960897|NCT00925990|B1|Baseline|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
960898|NCT00925990|P2|Participant Flow|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
960899|NCT00925990|P1|Participant Flow|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
960900|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
960901|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
960902|NCT00925990|O2|Outcome|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
960903|NCT00925990|O1|Outcome|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg (5 capsules) daily for patients weighing 75kg or less, and 1200 mg (6 capsules) daily for patients weighing more than 75 kg"
960904|NCT00925990|E2|Reported Event|CTS-1027 + Placebo|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Placebo, incactive capsules identical in appearance to ribavirin capusules. Five (for patients weighing 75 kg or less) or six (for patients weighing more than 75 kg) capsules taken in two divided daily doses."
960905|NCT00925990|E1|Reported Event|CTS-1027 + Ribavirin|"CTS-1027, 5mg and 10 mg tablets (one each) taken twice daily for a total daily dose of 30 mg.~Ribavirin, 200 mg capsules, taken in two divided daily doses totaling 1000 mg daily for patients weighing 75kg or less, and 1200 mg daily for patients weighing more than 75 kg"
960906|NCT00925938|B4|Baseline|Total|Total of all reporting groups
960907|NCT00925938|B3|Baseline|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960908|NCT00925938|B2|Baseline|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
960909|NCT00925938|B1|Baseline|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960910|NCT00925938|P3|Participant Flow|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960911|NCT00925938|P2|Participant Flow|MVPI 800 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 and Part 2 participants were included in this arm of the study.~Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB)."
960912|NCT00925938|P1|Participant Flow|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit.~Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960913|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960914|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
960915|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960916|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960917|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
961101|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
960918|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960919|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960920|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
960921|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960922|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960923|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
960924|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960925|NCT00925938|O3|Outcome|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960926|NCT00925938|O2|Outcome|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
960927|NCT00925938|O1|Outcome|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960928|NCT00925938|E3|Reported Event|MVPI Placebo|"One vaginal insert of placebo administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 and Part 2 participants were included in this arm of the study.~placebo : placebo"
960929|NCT00925938|E2|Reported Event|MVPI 800 Mcg|One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Following the initial dose, 400 mcg, the dose was increased to 800 mcg after the 400 mcg group cohort based on safety and efficacy criteria as assessed by the Data and Safety Monitoring Board (DSMB). Part 1 and Part 2 participants were included in this arm of the study.
960930|NCT00925938|E1|Reported Event|MVPI 400 Mcg|"One vaginal insert administered 18 - 24 hours prior to the scheduled hysteroscopy clinic visit. Part 1 participants were included in this arm of the study.~misoprostol : One vaginal insert containing 400 mcg misoprostol administered intravaginally one time and remain in place for 18 - 24 hours prior to the hysteroscopy procedure."
960931|NCT00925899|B3|Baseline|Total|Total of all reporting groups
960932|NCT00925899|B2|Baseline|Placebo. Then Melatonin|Placebo then melatonin: Placebo tablet orally every evening about one hour before bedtime for one week. Then one week melatonin 20 mg orally.
960933|NCT00925899|B1|Baseline|Melatonin, Then Placebo|Melatonin then placebo: 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then 1 week placebo.
960934|NCT00925899|P2|Participant Flow|Part 1: Placebo, Then Melatonin|"First one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week.~Then one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week."
960935|NCT00925899|P1|Participant Flow|Part 1: Melatonin, Then Placebo|"First one week Melatonin: 20 mg melatonin orally every evening about 1 hour before bedtime for one week.~Then one week Placebo: Placebo tablet orally every evening about one hour before bedtime for one week."
960936|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
960937|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
960938|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
960939|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
961095|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961096|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
960940|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
960941|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
961102|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
960942|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
960943|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between
960944|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
960945|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
960946|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
960947|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
960948|NCT00925899|O2|Outcome|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Three days wash out in between.
960949|NCT00925899|O1|Outcome|Melatonin Then Placebo|20 mg Melatonin orally every evening about 1 hour before bedtime for one week. Then Placebo tablet orally every evening about one hour before bedtime for one week. Three days wash out in between.
960950|NCT00925899|E2|Reported Event|Placebo Then Melatonin|Placebo tablet orally every evening about one hour before bedtime for one week. Then melatonin 20 mg. for one week.
960951|NCT00925899|E1|Reported Event|Melatonin Then Placebo|Melatonin 20 mg melatonin orally every evening about 1 hour before bedtime for one week. Then placebo for one week.
960952|NCT00925782|B1|Baseline|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
960953|NCT00925782|P2|Participant Flow|Alkeran - Melphalan|"Randomized group of Alkeran-Melphalan~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
960954|NCT00925782|P1|Participant Flow|Melphalan - Alkeran|"Randomized group of Melphalan - Alkeran sequence Melphalan HCl for Injection (Propylene Glycol-Free) (single-use glass vial containing melphalan HCl 56 mg powder [equivalent to 50 mg of melphalan free base] and 2700 mg sulfobutylether-beta-cyclodextrin Captisol) reconstituted with normal saline solution, 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter.~Alkeran for Injection (single-use glass vial containing melphalan HCl powder [equivalent to 50 mg melphalan] and 20 mg povidone) reconstituted with sterile diluent (containing sodium citrate, propylene glycol, ethanol, and Water for Injection), 100 mg/m2 melphalan HCl diluted with normal saline to concentration no greater than 0.45 mg/mL, infused over 30 minutes via a central venous catheter."
960955|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
960956|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
960957|NCT00925782|O1|Outcome|Open-label, Randomized, Crossover Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation.
960958|NCT00925782|O1|Outcome|Open-label, Randomized, Cross-over Study|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients
960959|NCT00925782|O2|Outcome|Alkeran|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Alkeran dose administration regardless of cross over sequence
960960|NCT00925782|O1|Outcome|Melphalan|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients. This group includes all patients with Melphalan dose administration regardless of cross over sequence
960961|NCT00925782|E1|Reported Event|All Study Participants|Open-label, randomized, cross-over design study where Propylene Glycol Free Melphalan and Alkeran were assessed in the same multiple myeloma patients undergoing transplantation. The time between randomized sequence of treatment is not sufficiently long to evaluate adverse events by intervention of or by sequence.
960976|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960977|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960962|NCT00925769|B1|Baseline|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (Dose levels [DL]-1, 2, 3, 4, 5 and 6) were administered either oral 100 mg or 150 mg of erlotinib tablet daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960963|NCT00925769|P6|Participant Flow|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960964|NCT00925769|P5|Participant Flow|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960965|NCT00925769|P4|Participant Flow|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960966|NCT00925769|P3|Participant Flow|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960967|NCT00925769|P2|Participant Flow|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960968|NCT00925769|P1|Participant Flow|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 milligrams (mg) of erlotinib (ERL) tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 milligrams per kilogram (mg/kg) of bevacizumab (BEV) intravenous (IV) infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 milligrams per square meter (mg/m^2) of capecitabine (CAP) tablet twice daily (BID) within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960969|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960970|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960971|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960972|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960973|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960974|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960975|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961086|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961087|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
960978|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960979|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960980|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960981|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960982|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960983|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960984|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960985|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960986|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960987|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960988|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960989|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960990|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960991|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960992|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961088|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
960993|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960994|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960995|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960996|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960997|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960998|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
960999|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961000|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961001|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961002|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961003|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961004|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961005|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961006|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961007|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961008|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961089|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961009|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961010|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961011|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961012|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961013|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961014|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961015|NCT00925769|O6|Outcome|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961016|NCT00925769|O5|Outcome|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961017|NCT00925769|O4|Outcome|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961018|NCT00925769|O3|Outcome|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961019|NCT00925769|O2|Outcome|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961020|NCT00925769|O1|Outcome|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID orally within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961021|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DL-1, 2, 3, 4, 5 and 6) were administered with either 100 mg or 150 mg of erlotinib daily orally, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961022|NCT00925769|O1|Outcome|Triple Combination (Bevacizumab/Erlotinib/Capecitabine)|Dose-escalation was performed using a substance-related toxicity-based dose escalation scheme and was started with capecitabine followed by erlotinib and completed by bevacizumab. Participants in different dose levels (DLs - 1, 2, 3, 4, 5 and 6) were administered either 100 mg or 150 mg of erlotinib tablet orally daily, 5 mg/kg or 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and any of the different doses of capecitabine BID (500/650/800/900 mg/m^2) orally. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961090|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961091|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961023|NCT00925769|E6|Reported Event|ERL+BEV+CAP Dose Level-6|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 10 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961024|NCT00925769|E5|Reported Event|ERL+BEV+CAP Dose Level-5|Participants were administered oral 150 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961025|NCT00925769|E4|Reported Event|ERL+BEV+CAP Dose Level-4|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 900 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961026|NCT00925769|E3|Reported Event|ERL+BEV+CAP Dose Level-3|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 800 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961027|NCT00925769|E2|Reported Event|ERL+BEV+CAP Dose Level-2|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 650 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961028|NCT00925769|E1|Reported Event|ERL+BEV+CAP Dose Level-1|Participants were administered oral 100 mg of erlotinib tablet daily at least 1 hour before or 2 hours after the ingestion of food, 5 mg/kg of bevacizumab IV infusion on Day 1 of each cycle (1 Cycle = 2 Weeks), and oral 500 mg/m^2 of capecitabine tablet BID within 30 minutes after the ingestion of food. All the medications were continued until confirmed evidence of disease progression or unacceptable toxicity.
961029|NCT00925704|B7|Baseline|Total|Total of all reporting groups
961030|NCT00925704|B6|Baseline|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
961031|NCT00925704|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
961032|NCT00925704|B4|Baseline|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
961033|NCT00925704|B3|Baseline|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
961034|NCT00925704|B2|Baseline|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
961035|NCT00925704|B1|Baseline|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
961036|NCT00925704|P6|Participant Flow|Sequence 6|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
961037|NCT00925704|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
961038|NCT00925704|P4|Participant Flow|Sequence 4|Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch)for one day in third intervention
961039|NCT00925704|P3|Participant Flow|Sequence 3|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in third intervention
961092|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961093|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961094|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961040|NCT00925704|P2|Participant Flow|Sequence 2|Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in first intervention, washout, Calcitriol (1.0 microgram) single dose at lunch for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
961041|NCT00925704|P1|Participant Flow|Sequence 1|Calcitriol (1.0 microgram) single dose at lunch for one day in first intervention, washout, Lanthanum carbonate (1000 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in second intervention, washout, Sevelamer carbonate (2400 mg three times daily with meals) + Calcitriol (1 microgram single dose at lunch) for one day in third intervention
961042|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the median of Tmax Sevelamer carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
961043|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the median of Tmax Lanthanum carbonate + Calcitriol minus the median of Tmax Calcitriol alone.
961044|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of Cmax Sevelamer carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
961045|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of Cmax Lanthanum carbonate + Calcitriol minus least squares mean of Cmax Calcitriol alone.
961046|NCT00925704|O2|Outcome|Calcitriol (Sevelamer Carbonate)|This group is the least squares mean of AUC 0-48 Sevelamer carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
961047|NCT00925704|O1|Outcome|Calcitriol (Lanthanum Carbonate)|This group is the least squares mean of AUC 0-48 Lanthanum carbonate + Calcitriol minus least squares mean of AUC 0-48 Calcitriol alone.
961048|NCT00925704|E3|Reported Event|Calcitriol Alone|Calcitriol (1.0 microgram) single dose at lunch
961049|NCT00925704|E2|Reported Event|Sevelamer Carbonate + Calcitriol|Sevelamer carbonate (2400 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
961050|NCT00925704|E1|Reported Event|Lanthanum Carbonate + Calcitriol|Lanthanum carbonate (1000 mg three times daily with meals for one day) + Calcitriol (1 microgram single dose at lunch)
961051|NCT00925600|B3|Baseline|Total|Total of all reporting groups
961052|NCT00925600|B2|Baseline|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961053|NCT00925600|B1|Baseline|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
961054|NCT00925600|P2|Participant Flow|Denosumab|Participants randomized to receive denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961055|NCT00925600|P1|Participant Flow|Placebo|Participants randomized to receive placebo administered by subcutaneous injection on Day 1 and at Month 6.
961056|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961057|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
961058|NCT00925600|O4|Outcome|Denosumab - Right Eye|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961059|NCT00925600|O3|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961060|NCT00925600|O2|Outcome|Placebo - Right Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
961061|NCT00925600|O1|Outcome|Placebo - Left Eye|Participants received placebo subcutaneous injection on Day 1 and at Month 6.
961062|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961063|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
961064|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961065|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
961066|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961067|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
961068|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961069|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
961070|NCT00925600|O2|Outcome|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961071|NCT00925600|O1|Outcome|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
961072|NCT00925600|E2|Reported Event|Denosumab|Participants received denosumab 60 mg administered by subcutaneous injection on Day 1 and at Month 6.
961073|NCT00925600|E1|Reported Event|Placebo|Participants received placebo administered by subcutaneous injection on Day 1 and at Month 6.
961074|NCT00925587|B3|Baseline|Total|Total of all reporting groups
961075|NCT00925587|B2|Baseline|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961076|NCT00925587|B1|Baseline|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961077|NCT00925587|P2|Participant Flow|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961078|NCT00925587|P1|Participant Flow|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961079|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961080|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961081|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961082|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961083|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961084|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961085|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961097|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961098|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961099|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961726|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961103|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961104|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961105|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961106|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961107|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961108|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961109|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961110|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961111|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961112|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961113|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961114|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961115|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961116|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961117|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961118|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961119|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961120|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961121|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961122|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961123|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961124|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961125|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961126|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961127|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961128|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961129|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961130|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961131|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961132|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961133|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961134|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961135|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961136|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961137|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961138|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961139|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961140|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961141|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961142|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961143|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961144|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961145|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961146|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961147|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961148|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961149|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961150|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961151|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961152|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961153|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961154|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961155|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961156|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961157|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961158|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961159|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961160|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961161|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961237|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
961162|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961163|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961164|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961165|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961166|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961167|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961168|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961169|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961170|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961171|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961172|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961173|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961174|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961175|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961176|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961177|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961178|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961179|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961180|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961181|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961182|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961183|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961184|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961185|NCT00925587|O2|Outcome|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961186|NCT00925587|O1|Outcome|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961187|NCT00925587|E2|Reported Event|Darbepoetin Alfa QM|Darbepoetin alfa Intravenous Once Monthly
961188|NCT00925587|E1|Reported Event|Darbepoetin Alfa Q2W|Darbepoetin alfa Intravenous Once Every 2 Weeks
961189|NCT00925548|B3|Baseline|Total|Total of all reporting groups
961190|NCT00925548|B2|Baseline|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961191|NCT00925548|B1|Baseline|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961192|NCT00925548|P2|Participant Flow|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 grams per liter (g/L) infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961193|NCT00925548|P1|Participant Flow|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961194|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961238|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
961239|NCT00925288|E2|Reported Event|Modified Schedule|Duration: 0,3,6 months
961240|NCT00925288|E1|Reported Event|Regular Schedule|Duration: 0,2,6 months
961241|NCT00924950|B1|Baseline|Ointment + Patch vs. Ointment Alone|
961290|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961325|NCT00924638|B2|Baseline|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961242|NCT00924950|P1|Participant Flow|Ointment + Patch vs. Ointment Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used topically to treat one psoriatic plaque with Hydrogel patch used over for occlusion for 6-8 hours daily. Within the same patient another patch of similar severity was chosen and was treated with Taclonex ointment alone without hydrogel patch occlusion
961243|NCT00924950|O2|Outcome|Taclonex Alone|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily without hydrogel patch.
961327|NCT00924638|P2|Participant Flow|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961195|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961196|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961197|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961198|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961199|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961200|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961201|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961202|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961203|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961204|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961288|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK3578 IV was administered QW. Participants were randomized to receive 1 mcg of MK-2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961205|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961206|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961207|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961208|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961209|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961210|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961211|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961212|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961213|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961214|NCT00925548|O2|Outcome|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961289|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961215|NCT00925548|O1|Outcome|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961216|NCT00925548|E2|Reported Event|Placebo + Hormonal Therapy + NaCl 9 g/L|Single dose of sodium chloride (NaCl) 9 g/L infusion as substitute for cyclophosphamide was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous placebo doses matched to tecemotide (L-BLP25) along with hormonal therapy were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous placebo doses along with hormonal therapy were administered every 6 weeks until progressive disease (PD) was documented.
961217|NCT00925548|E1|Reported Event|Tecemotide (L-BLP25) + Hormonal Therapy + Cyclophosphamide|Single dose of cyclophosphamide (300 milligrams per square meter [mg/m^2] to a maximum of 600 mg) was administered intravenously, 3 days prior to the start of vaccination, followed by primary treatment phase in which weekly subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered for 8 weeks, followed by maintenance treatment phase starting at Week 14 (6 weeks after the last dosing of the primary treatment phase), in which subcutaneous vaccinations with tecemotide (L-BLP25) 1000 micrograms (actual delivered dose was 930 micrograms) along with hormonal treatment were administered every 6 weeks until progressive disease (PD) was documented.
961218|NCT00925522|B1|Baseline|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids."
961219|NCT00925522|P1|Participant Flow|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of following three system components:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the cat"
961220|NCT00925522|O1|Outcome|Therapy Cool Path Duo Catheter|All patients received RF (radio frequency) therapy from ablation catheter.
961221|NCT00925522|E1|Reported Event|Therapy Cool Path Duo Cardiac Ablation System|"Therapy Cool Path Duo Cardiac Ablation System: Consists of:~A flexible, insulated 7F all braided catheter that contains an internal lumen connected to 12 open conduits at the 4mm tip electrode for infusion of heparinized saline during radiofrequency ablation; records intracardiac electrograms and can be utilized for cardiac simulation during diagnostic electrophysiologic studies/evaluation.~The 1500T9-VT generator is a microprocessor-controlled device that produces a continuous unmodulated radiofrequency (RF) output of 485 kHz. The Generator will be used in Temperature Control mode only. The catheter delivers the RF power from the generator in a monopolar mode between its distal electrode (tip electrode) and a large indifferent electrode.~The Cool Point ™ Irrigation Pump and Cool Point™ Tubing Set is an external volumetric pump that is intended for use in administration of general I.V. fluids to patient’s vascular system through the catheter in the hospital environment."
961222|NCT00925353|B1|Baseline|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
961223|NCT00925353|P1|Participant Flow|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
961224|NCT00925353|O1|Outcome|Lidocaine Gel Group|Plasma concentration of lidocaine and MEGX after one-time application of 1 oz. of 4% lidocaine gel (TOPICAINE) on the skin of the breasts and chest wall as recommended for use as as pre-medication to reduce discomfort during screening mammography.
961225|NCT00925353|E1|Reported Event|Lidocaine Gel|1 ounce of lidocaine gel applied the skin of the breasts and chest wall covered by plastic wrap for one hour
961226|NCT00925288|B3|Baseline|Total|Total of all reporting groups
961227|NCT00925288|B2|Baseline|Modified Schedule|Duration: 0,3,6 months
961228|NCT00925288|B1|Baseline|Regular Schedule|Duration: 0,2,6 months
961229|NCT00925288|P2|Participant Flow|Modified Schedule|Duration: 0,3,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
961230|NCT00925288|P1|Participant Flow|Regular Schedule|Duration: 0,2,6 months each dose Dose form: standard injectable HPV4 vaccine Groups: FSWs 18-26 years of age
961231|NCT00925288|O2|Outcome|Modified Schedule|Participants in 0,3,6 month study arm
961232|NCT00925288|O1|Outcome|Regular Schedule|Participants in 0,2,6 month study arm
961233|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
961234|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
961235|NCT00925288|O2|Outcome|Modified Schedule|Duration: 0,3,6 months
961236|NCT00925288|O1|Outcome|Regular Schedule|Duration: 0,2,6 months
961244|NCT00924950|O1|Outcome|Taclonex Ointment Occluded With Hydrogel Patch|Taclonex (calcipotriene 0.005% and betamethasone dipropionate 0.064%) ointment used daily topically to treat one psoriatic plaque, occluded with hydrogel patch for 6-8 hours each day.
961245|NCT00924950|E1|Reported Event|Ointment + Patch vs. Ointment Alone|
961246|NCT00924898|B1|Baseline|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
961247|NCT00924898|P1|Participant Flow|Acute HIV Infection Treatment Group|This study was a dual-center, single-arm open-label study of the safety and efficacy of once daily, FTC/TDF/EFZ administered to participants with acute HIV infection
961248|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants who remained on treatment at designated time points.
961249|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Baseline resistance testing was performed on all participants at enrollment.
961250|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Acute HIV infection treatment group
961251|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants who remained on study with viral suppression at week 96
961252|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <50 copies/mL prior at week 48
961253|NCT00924898|O1|Outcome|Acute HIV Infection Treatment Group|Participants suppressed to <200 copies/mL prior to or at week 24
961254|NCT00924898|E1|Reported Event|Acute HIV Infection Treatment Group|Single-arml study of once daily emtricitabine/tenofovir/efavirenz administered to participants with acute HIV infection
961255|NCT00924833|B4|Baseline|Total|Total of all reporting groups
961256|NCT00924833|B3|Baseline|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
961257|NCT00924833|B2|Baseline|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
961258|NCT00924833|B1|Baseline|Placebo|Placebo tablets. One tablet twice daily.
961259|NCT00924833|P3|Participant Flow|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
961260|NCT00924833|P2|Participant Flow|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
961261|NCT00924833|P1|Participant Flow|Placebo|Placebo tablets. One tablet twice daily.
961262|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
961263|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
961264|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
961265|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
961266|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
961267|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
961268|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
961269|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
961270|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
961271|NCT00924833|O3|Outcome|Nebivolol|Nebivolol 5 mg tablets. One nebivolo tablet daily. One placebo tablet daily.
961272|NCT00924833|O2|Outcome|Carvedilol|Carvedilol 25 mg tablets. One tablet twice daily.
961273|NCT00924833|O1|Outcome|Placebo|Placebo tablets. One tablet twice daily.
961274|NCT00924807|B1|Baseline|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
961275|NCT00924807|P1|Participant Flow|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
961276|NCT00924807|O1|Outcome|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
961277|NCT00924807|E1|Reported Event|Androgen Depr, Radiotherapy, Sorafenib|"Everyone will receive Leuprolide acetate, Bicalutamide,Sorafenib and radiotherapy.~Leuprolide acetate, Bicalutamide, Sorafenib: Leuprolide acetate - depot, Bicalutamide 50 mg, Sorafenib 400mg"
961278|NCT00924781|B5|Baseline|Total|Total of all reporting groups
961279|NCT00924781|B4|Baseline|MK2578 1mcg/350U QM|MK2578 IV administered QM.
961280|NCT00924781|B3|Baseline|MK2578 1mcg/350U QW|MK2578 IV administered QW.
961281|NCT00924781|B2|Baseline|MK2578 1mcg/600U QM|MK2578 IV administered QM.
961282|NCT00924781|B1|Baseline|MK2578 1mcg/600U QW|MK2578 IV administered QW.
961283|NCT00924781|P2|Participant Flow|MK2578 1mcg/600 U or 1 mg/350 U QM|MK2578 was administered IV QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) or 350 units of Epogen (epoetin alpha) received per week at Baseline.
961284|NCT00924781|P1|Participant Flow|MK2578 1mcg/600 U or 1 mcg/350 U QW|MK2578 was administered intravenously (IV) QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
961285|NCT00924781|O4|Outcome|MK-2578 1mcg/350U QM|MK2578 IV was administered QM. Participatns were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alpha) received per 4 weeks at Baseline.
961286|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
961287|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
961291|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961292|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961727|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961293|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961294|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every U of Epogen (epoetin alpha) received per week at Baseline.
961295|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961296|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961297|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM.Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961298|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961299|NCT00924781|O2|Outcome|MK2578 1mcg/600 QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961300|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961301|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961302|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961303|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961304|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961305|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961306|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961307|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961308|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961309|NCT00924781|O4|Outcome|MK2578 1mcg/350U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961310|NCT00924781|O3|Outcome|MK2578 1mcg/350U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 350 U of Epogen (epoetin alpha) received per week at Baseline.
961311|NCT00924781|O2|Outcome|MK2578 1mcg/600U QM|MK2578 IV was administered QM. Participants were randomized to receive 1 mcg of MK2578 for every 600 U of Epogen (epoetin alpha) received per week at Baseline.
961312|NCT00924781|O1|Outcome|MK2578 1mcg/600U QW|MK2578 IV was administered QW. Participants were randomized to receive 1 mcg of MK2578 for every 600 Units (U) of Epogen (epoetin alfa) received per week at Baseline.
961313|NCT00924781|E2|Reported Event|MK2578 QM|MK2578 IV administered once every 4 weeks.
961314|NCT00924781|E1|Reported Event|MK2578 QW|MK2578 IV administered once weekly.
961315|NCT00924729|B3|Baseline|Total|Total of all reporting groups
961316|NCT00924729|B2|Baseline|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961317|NCT00924729|B1|Baseline|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961318|NCT00924729|P2|Participant Flow|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961319|NCT00924729|P1|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961320|NCT00924729|O2|Outcome|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961321|NCT00924729|O1|Outcome|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961322|NCT00924729|E2|Reported Event|Besifloxacin 0.6% Ophthalmic Suspension|The patients in this group received one drop of besifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961323|NCT00924729|E1|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution|The patients in this group received one drop of moxifloxacin every 10 minutes for a total of 4 doses, with the last dose given 30+-2 minutes prior to the time of initiating the cataract incision.
961326|NCT00924638|B1|Baseline|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961728|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961328|NCT00924638|P1|Participant Flow|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961329|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961330|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961331|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961332|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961333|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961334|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961335|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961336|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961337|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961338|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961339|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961340|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961341|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961342|NCT00924638|O2|Outcome|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961343|NCT00924638|O1|Outcome|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961344|NCT00924638|E2|Reported Event|Control Arm|Follow-up at the same frequency, but with no Insertable Cardiac Monitor
961345|NCT00924638|E1|Reported Event|Continuous Monitoring|"Continuous cardiac monitoring by the Reveal® XT Insertable Cardiac Monitor~Reveal® XT Insertable Cardiac Monitor: The Insertable Cardiac Monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. ECG data are stored when the device detects a cardiac arrhythmia."
961346|NCT00924560|B4|Baseline|Total|Total of all reporting groups
961347|NCT00924560|B3|Baseline|Untreated Control|Participants received no oral contraceptives during the study.
961348|NCT00924560|B2|Baseline|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961349|NCT00924560|B1|Baseline|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961350|NCT00924560|P3|Participant Flow|Untreated Control|Participants received no oral contraceptives during the study.
961351|NCT00924560|P2|Participant Flow|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961352|NCT00924560|P1|Participant Flow|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961353|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961701|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961354|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961355|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961356|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961357|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961358|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961359|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961360|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961361|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961362|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961363|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961364|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961365|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961366|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961367|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961368|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961369|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961370|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961371|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961372|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961373|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961374|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961375|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961376|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961377|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961378|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961379|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961380|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961381|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961382|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961383|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961384|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961702|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961385|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961386|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961729|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961730|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961387|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961388|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg LNG/30 μg EE, followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961389|NCT00924560|O3|Outcome|Untreated Control|Participants received no oral contraceptives during the study.
961390|NCT00924560|O2|Outcome|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets containing 100 μg LNG/20 μg EE followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961391|NCT00924560|O1|Outcome|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961392|NCT00924560|E3|Reported Event|Untreated Control|Participants received no oral contraceptives during the study.
961393|NCT00924560|E2|Reported Event|28-day Levonorgestrel OC|Participants received a 28-day regimen consisting of 21 consecutive days of active combination tablets (containing 100 μg LNG/20 μg EE) followed by 7 days of placebo tablets for a total of 52 weeks (13 consecutive 28-day cycles).
961394|NCT00924560|E1|Reported Event|91-day Levonorgestrel OC|Participants received a 91-day regimen consisting of 84 consecutive days of active combination tablets containing 150 μg levonorgestrel (LNG)/30 μg ethinyl estradiol (EE), followed by 7 days of 10 μg EE tablets for a total of 52 weeks (4 consecutive 91-day cycles).
961395|NCT00924508|B1|Baseline|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
961396|NCT00924508|P1|Participant Flow|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
961397|NCT00924508|O1|Outcome|Hydrogel Patch Alone, TAC 0.1%, TAC + Patch|"This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, the second treated with 0.1 % triamcinolone ointment without patch, and the third treated with occlusion of eczema patch without ointment.~occlusion of eczema patch with hydrogel and 0.1 % triamcinolone ointment, occlusion alone, and ointment alone"
961398|NCT00924508|O3|Outcome|Patch + TAC|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily and triamcinolone (TAC) 0.1% cream twice daily to one lesion. After 4 weeks of occlusion + TAC treatment, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
961399|NCT00924508|O2|Outcome|TAC 0.1%|Patients were instructed to apply TAC 0.1% twice daily to one lesion. After 4 weeks, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
961400|NCT00924508|O1|Outcome|Hydrogel Patch|Patients were instructed to apply the hydrogel patch over one lesion for 6-8 hours daily. After 4 weeks of occlusion therapy, treatment was discontinued and final evaluation was conducted after a 2-week observation period involving no active therapy.
961401|NCT00924508|E1|Reported Event|TAC With Hydrogel Patch, Hydrogel Patch Alone, TAC Alone|This is a single arm study. Each subject had 3 target lesions; one treated with occlusion of lesion by hydrogel patch and 0.1% TAC, the second treated with 0.1% TAC without occlusion, and the third treated with occlusion of eczema lesion by hydrogel patch without TAC.
961402|NCT00924482|B1|Baseline|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
961403|NCT00924482|P1|Participant Flow|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
961419|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961703|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961704|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961420|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961404|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
961405|NCT00924482|O1|Outcome|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
961406|NCT00924482|E1|Reported Event|Adult Cardiac Surgery Patients|"Cardiac output measurements were made in adult patients undergoing cardiac surgery. Cases included coronary artery revascularization, both on, off pump, and robotic, aortic valvular replacement, mitral valvular repair or replacement, and aortic root replacement.~Measurement of cardiac output made with the Conmed ECOM 6-3D endotracheal tube was compared to those made with a pulmonary artery catheter. Correlation studies of cardiac output were done against those performed using the standard thermodilution technique in patients, who in the normal course of their clinical care, were having cardiac outputs measured by the thermodilution technique. Cardiac output measured was compared by impedance cardiography to transit time measurements.~Correlation study completed in the O.R. and intensive care units on patients who were scheduled for cardiac surgery who routinely have cardiac output measurements using the standard thermodilution method."
961407|NCT00924469|B3|Baseline|Total|Total of all reporting groups
961408|NCT00924469|B2|Baseline|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961409|NCT00924469|B1|Baseline|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961410|NCT00924469|P2|Participant Flow|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961411|NCT00924469|P1|Participant Flow|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961412|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961413|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961414|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961415|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961416|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961417|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961418|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961421|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961422|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961423|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961424|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961425|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961426|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961427|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961428|NCT00924469|O2|Outcome|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961429|NCT00924469|O1|Outcome|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961430|NCT00924469|E2|Reported Event|Leuprolide Then Abiraterone Plus Leuprolide Plus Prednisone|Leuprolide acetate was administered at a dose of 22.5 mg as intramuscular injection once every 12 weeks up to Week 24. From Week 13 to 24, abiraterone acetate tablets were administered orally at a total dose of 1000 mg per day with prednisone administered orally as 5 mg tablets once daily.
961431|NCT00924469|E1|Reported Event|Abiraterone Plus Leuprolide Plus Prednisone|Abiraterone acetate tablets were administered orally at a total dose of 1000 milligram (mg) per day up to Week 24. Leuprolide acetate was administered at a dose of 22.5 mg (dose adjusted as per Investigator's discretion) as intramuscular injection (injection of a substance into a muscle) once every 12 weeks up to Week 24. Prednisone was administered orally as 5 mg tablets once daily for 24 weeks.
961432|NCT00924443|B1|Baseline|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
961433|NCT00924443|P1|Participant Flow|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days
961434|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
961435|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
961436|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
961437|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
961438|NCT00924443|O1|Outcome|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
961439|NCT00924443|E1|Reported Event|Clofarabine|Clofarabine 30 mg/m^2/day intravenously over 1 hour for 5 days every 28 to 42 days(one cycle) and 20 mg/m^2/day intravenously over 1 hour for 5 days every 29 to 43 days for second and subsequent cycles,up to a maximum of 3 cycles.
961525|NCT00924053|E3|Reported Event|EGT0001474 75 mg|Received three 25mg capsules once daily.
961526|NCT00924053|E2|Reported Event|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961529|NCT00924040|P1|Participant Flow|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961731|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961440|NCT00924352|B1|Baseline|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961441|NCT00924352|P2|Participant Flow|Phase II|The Phase II sample includes patients who were enrolled into the Phase II portion of this study. Dasatinib and ixabepilone were administered at the maximum tolerated dose determined during the Phase I portion: dasatinib 100 mg daily and ixabepilone 20 mg/m2. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
961442|NCT00924352|P1|Participant Flow|Phase I|The Phase I sample includes patients who were enrolled into the Phase I portion of this study. Patients received treatment according to the assigned dose level. Ixabepilone was administered over 1 hour on Days 1, 8, and 15 of a 28-day cycle. Dasatinib was administered continuously starting on Day 1, Cycle 1 once daily. Patients were treated with both agents for up to 8 cycles, after which stable or responding patients were eligible for dasatinib monotherapy at the investigator's discretion in the absence of disease progression or unacceptable toxicity.
961443|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961444|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961445|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961446|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961447|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961448|NCT00924352|O3|Outcome|Ixabepilone + Dasatinib (Dose Level 2)|Dasatinib 140 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
961449|NCT00924352|O2|Outcome|Ixabepilone + Dasatinib (Dose Level 1)|Dasatinib 100 mg daily and Ixabepilone 20 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
961450|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib (Dose Level 0)|Dasatinib 100 mg daily and Ixabepilone 16 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
961527|NCT00924053|E1|Reported Event|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961451|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961452|NCT00924352|O1|Outcome|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961453|NCT00924352|E1|Reported Event|Ixabepilone + Dasatinib|"Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL. Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2.~Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Dasatinib: Dasatinib tablets will be administered continuously starting on Day 1, Cycle 1 once daily (QD).Dose Level 2;140 mg QD,Dose Level 1;100 mg QD,Dose Level 0 (Starting Dose);100 mg QD,Dose Level − 1;100 mg QD,Dose Level − 2;70 mg QD.~Ixabepilone: Ixabepilone, for injection 15 mg supplied with diluent for ixabepilone, 8 mL.~Dose Level 2;20 mg/m2,Dose Level 1;20 mg/m2,Dose Level 0 (Starting Dose);16 mg/m2,Dose Level − 1;12 mg/m2,Dose Level − 2;12 mg/m2."
961454|NCT00924313|B1|Baseline|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
961455|NCT00924313|P1|Participant Flow|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
961456|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
961457|NCT00924313|O1|Outcome|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
961458|NCT00924313|E1|Reported Event|11C-acetate for Prostate Cancer Patients|11C-acetate positron emission tomography (PET)/computed tomography (CT)for 30 minutes, intravenous bolus injection
961459|NCT00924287|B1|Baseline|Metastatic Cancer|Cancer that has invaded other parts of the body
961460|NCT00924287|P1|Participant Flow|Metastatic Cancer|Cancer that has invaded other parts of the body
961461|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
961462|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
961463|NCT00924287|O1|Outcome|Metastatic Cancer|Cancer that has invaded other parts of the body
961464|NCT00924287|E1|Reported Event|Metastatic Cancer|Cancer that has invaded other parts of the body
961465|NCT00924209|B1|Baseline|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
961466|NCT00924209|P1|Participant Flow|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
961467|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
961468|NCT00924209|O1|Outcome|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
961469|NCT00924209|E1|Reported Event|Stage IIIA Lung Cancer Patients|Non-squamous cell non small cell lung cancer treated with 1250 mg/m^2 gemcitabine dose for two doses on day 1 and day 8 every 21 days,80 mg/m^2 cisplatin day 1 every 21 days for 3 cycles, 7.5 mg/kg bevacizumab on day 1 every 21 days for first 2 cycles only, and 100 mg/m^2 intravenous, and 100 mg/m^2 etoposide intravenous per day for consecutive 3 days on days 1 to 3 every 3 weeks for 4 cycles
961470|NCT00924066|B1|Baseline|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
961528|NCT00924040|B1|Baseline|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961471|NCT00924066|P1|Participant Flow|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
961472|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
961473|NCT00924066|O1|Outcome|Squamous and Nonsquamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes. All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
961474|NCT00924066|E1|Reported Event|Adverse Events for Squamous and Non-squamous Participants|"Squamous cell carcinoma is a histologic subtype of cervical cancer. Squamous cell carcinoma of the cervix (80%) is much more common than adenocarcinoma of the cervix.~Non squamous carcinoma is a histologic subtype of cervical cancer. It is the second most common form of cervical cancer; consists of adenocarcinoma, adenosquamous and non squamous (not otherwise specified) subtypes.~All participants in both arms received ixabepilone 6 mg/m^2 x 5 days, each cycle."
961475|NCT00924053|B5|Baseline|Total|Total of all reporting groups
961476|NCT00924053|B4|Baseline|EGT0001474 150mg|Received six 25 mg capsules once daily.
961477|NCT00924053|B3|Baseline|EGT0001474 75 mg|Received three 25mg capsules once daily.
961478|NCT00924053|B2|Baseline|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961479|NCT00924053|B1|Baseline|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961480|NCT00924053|P4|Participant Flow|EGT0001474 150mg|Received six 25 mg capsules once daily.
961481|NCT00924053|P3|Participant Flow|EGT0001474 75 mg|Received three 25mg capsules once daily.
961482|NCT00924053|P2|Participant Flow|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961483|NCT00924053|P1|Participant Flow|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961484|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961485|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961486|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961487|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961488|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961489|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961490|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961491|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961492|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961493|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961494|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961495|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961496|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961497|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961498|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961499|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961500|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961501|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961502|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961503|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961504|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961505|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961506|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961507|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961508|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961509|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961510|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961511|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961512|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961513|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961514|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961515|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961516|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961517|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961518|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961519|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961520|NCT00924053|O4|Outcome|EGT0001474 150mg|Received six 25 mg capsules once daily.
961521|NCT00924053|O3|Outcome|EGT0001474 75 mg|Received three 25mg capsules once daily.
961522|NCT00924053|O2|Outcome|EGT0001474 25 mg|Received one 25 mg capsule once daily.
961523|NCT00924053|O1|Outcome|Placebo|Received 1, 3, or 6 placebo capsules once daily.
961524|NCT00924053|E4|Reported Event|EGT0001474 150mg|Received six 25 mg capsules once daily.
961530|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961531|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961532|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961533|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961534|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961535|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961536|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961537|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961538|NCT00924040|O1|Outcome|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961539|NCT00924040|E1|Reported Event|BL22 Immunotherapy|30 micrograms/kg intravenous over 30 minutes every other day (QOD) on days 1, 3, 5, of a 4 week cycle (at least 26 days) for a maximum of 16 cycles or until they become ineligible.
961540|NCT00924001|B1|Baseline|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
961541|NCT00924001|P1|Participant Flow|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
961542|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
961543|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
961544|NCT00924001|O1|Outcome|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
961545|NCT00924001|E1|Reported Event|Metastatic Melanoma|Melanoma that has invaded deep into the skin, lymph nodes, or other parts of the body.
961546|NCT00923975|B1|Baseline|Intended Users of the Software|Baseline measures were analyzed using only data for the young adults (18-24 years of age) and parents/guardians (18 to 47 years of age) of children with diabetes, not healthcare professionals. Data was not used from one subject withdrawn from the study because the subject did not meet inclusion criteria.
961547|NCT00923975|P1|Participant Flow|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
961548|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
961549|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
961550|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
961551|NCT00923975|O1|Outcome|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
961552|NCT00923975|E1|Reported Event|Intended Users of the Software|35 young adults (age 18 to 24) with diabetes, 12 Parents/legal guardians of children with diabetes, and 3 healthcare professionals who work with this population used a diabetes data management program.
961553|NCT00923949|B1|Baseline|Pioglitazone|45 mg tablet daily by mouth for six weeks
961554|NCT00923949|P1|Participant Flow|Pioglitazone|45 mg tablet daily by mouth for six weeks
961555|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
961556|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
961557|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
961558|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
961559|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
961560|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
961561|NCT00923949|O1|Outcome|Pioglitazone|45 mg tablet daily by mouth for six weeks
961562|NCT00923949|E1|Reported Event|Pioglitazone|45 mg tablet daily by mouth for six weeks
961563|NCT00923936|B3|Baseline|Total|Total of all reporting groups
961564|NCT00923936|B2|Baseline|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961676|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961677|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961705|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961706|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961565|NCT00923936|B1|Baseline|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961566|NCT00923936|P2|Participant Flow|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961567|NCT00923936|P1|Participant Flow|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961568|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961569|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961570|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961571|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961572|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961573|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m2^ and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961574|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961575|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961678|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961679|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961680|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961681|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961576|NCT00923936|O2|Outcome|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961577|NCT00923936|O1|Outcome|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961578|NCT00923936|E2|Reported Event|All Other Advanced HIV-associated Kaposi's Sarcoma (KS)|"All other patients with advanced AIDS-associated KS~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961579|NCT00923936|E1|Reported Event|KS; Classic or HIV+ Not Improved on Antivirals|"Kaposi's sarcoma (KS) in patients who are Human immunodeficiency virus (HIV) Negative, HIV infected with stable disease for one year despite antiretroviral therapy or progressive disease despite 4 months of antiretroviral therapy.~Liposomal Doxorubicin: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles.~Bevacizumab: Induction phase dose: Intravenous (IV) bevacizumab 15 mg/kg once, followed 7 days later by liposomal doxorubicin mg/m^2 and bevacizumab every 3 weeks for six cycles. Maintenance phase dose: IV bevacizumab every 3 weeks for 11 cycles."
961580|NCT00923910|B3|Baseline|Total|Total of all reporting groups
961581|NCT00923910|B2|Baseline|Recipients|Vaccine and donor lymphocyte prep
961582|NCT00923910|B1|Baseline|Donors|Donor lymphocyte collection via apheresis.
961583|NCT00923910|P2|Participant Flow|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
961584|NCT00923910|P1|Participant Flow|Donors|Period 1 -Donor lymphocyte collection via apheresis. Period 2 -Donor cell processing for vaccine and infusion.
961585|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
961586|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
961587|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
961588|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
961589|NCT00923910|O1|Outcome|Recipients|Period 1 - Vaccine and donor lymphocyte prep Period 2 - Vaccine and donor lymphocyte administration.
961590|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
961591|NCT00923910|O1|Outcome|Recipients|Vaccine and donor lymphocyte prep
961592|NCT00923910|E1|Reported Event|Recipients|Vaccine and donor lymphocyte prep
961593|NCT00923845|B3|Baseline|Total|Total of all reporting groups
961594|NCT00923845|B2|Baseline|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
961595|NCT00923845|B1|Baseline|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
961596|NCT00923845|P2|Participant Flow|Recipients|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
961597|NCT00923845|P1|Participant Flow|Donors|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
961598|NCT00923845|O2|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
961599|NCT00923845|O1|Outcome|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
961600|NCT00923845|O1|Outcome|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
961601|NCT00923845|E2|Reported Event|Recipient|Recipients undergo induction therapy, allogeneic stem cell therapy and GVHD prophylaxis.
961602|NCT00923845|E1|Reported Event|Donor|A sibling who is 6/6 HLA --matched with the recipient. Donors undergo donor lymphocyte harvest and stem cell mobilization and harvest.
961603|NCT00923481|B1|Baseline|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
961604|NCT00923481|P1|Participant Flow|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
961605|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
961606|NCT00923481|O1|Outcome|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
961607|NCT00923481|E1|Reported Event|Multi-kinase Inhibitor Fosamatinib Disodium|200 mg BID was the administered dose for the initial part of the study and then a phase I dose escalation was added with 100 mg as the starting dose.
961608|NCT00923351|B3|Baseline|Total|Total of all reporting groups
961682|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961683|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961684|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961685|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961609|NCT00923351|B2|Baseline|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
961610|NCT00923351|B1|Baseline|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
961611|NCT00923351|P3|Participant Flow|Enrolled But Not Assigned to Treatment|Twelve participants were not treated in Arm A or Arm B because they did not get far enough in the study to be designated for an Arm. Were unable to obtain apheresis, and adequate tumor samples.
961612|NCT00923351|P2|Participant Flow|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose subcutaneous (SQ) (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
961613|NCT00923351|P1|Participant Flow|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participant will receive Tumor lysate/keyhole limpet hemocyanin (KLH) pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
961614|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
961615|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
961616|NCT00923351|O2|Outcome|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
961617|NCT00923351|O1|Outcome|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
961618|NCT00923351|E2|Reported Event|Arm B - Participants Who Received rhIL-7|"Eight patients with rhabdomyosarcoma, fifteen patients with Ewings sarcoma family or tumors (ESFT), two patients with desmoplastic small round cell tumor, and one patient with synovial cell sarcoma participants will receive CYT107 20 mcg/kg/dose SQ (approx. 48h prior to vaccine[Day 0]), Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infuse 8H9/CD25 depleted autologous lymphocyte infusion on Day 2, followed by CYT107 20 mcg/kg/dose SQ on days 14, 28 and 42 (± 7 days), and Tumor lysate/KLH pulsed dendritic cell vaccine on Days 16, 30, 44, 56, and 70 (± 7 days).~Apheresis/flow cytometry/delayed type of hypersensitivity (DTH) responses for immune endpoint monitoring (skin tests) will be performed on Week 8, 14, 20 (Arm A) and on Days 42, 84 and 126 (+/- 7 days) (Arm B); and radiographic studies for clinical restaging will be performed on Week 8 and 20 (Arm A) and Days 42 and 126 (+/- 7 days) (Arm B)."
961686|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961687|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961688|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961619|NCT00923351|E1|Reported Event|Arm A - Participants Who Did Not Receive rhIL-7|Six patients with Ewings sarcoma family or tumors (ESFT) participants will receive cytotoxic/lympholytic therapy with cyclophosphamide and fludarabine (if cluster of differentiation 4 (CD4) count > 200 cells/mcl). Participants will receive Tumor lysate/KLH pulsed dendritic cell vaccine followed by Infusion of 8H9/CD25 depleted autologous lymphocyte infusion on Day 1, followed by Tumor lysate/KLH pulsed dendritic cell vaccine on week 4, 6, 8, 10, and 12.
961620|NCT00923273|B6|Baseline|Total|Total of all reporting groups
961621|NCT00923273|B5|Baseline|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
961622|NCT00923273|B4|Baseline|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
961623|NCT00923273|B3|Baseline|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
961624|NCT00923273|B2|Baseline|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
961625|NCT00923273|B1|Baseline|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
961626|NCT00923273|P5|Participant Flow|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
961627|NCT00923273|P4|Participant Flow|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
961628|NCT00923273|P3|Participant Flow|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
961629|NCT00923273|P2|Participant Flow|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
961630|NCT00923273|P1|Participant Flow|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
961631|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
961632|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
961633|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
961634|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
961635|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
961636|NCT00923273|O1|Outcome|Treatment Level 4: 10mg Load|"Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2~Includes 8 subjects with prior peme; 12 subjects who were peme naive;and 7 subjects rolled over from ph I"
961637|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
961638|NCT00923273|O4|Outcome|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
961639|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
961640|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
961641|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
961642|NCT00923273|O5|Outcome|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
961643|NCT00923273|O4|Outcome|Treatment Level 4: 10mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
961644|NCT00923273|O3|Outcome|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2 All subjects completed the intervention and phase I outcome measure.
961645|NCT00923273|O2|Outcome|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
961646|NCT00923273|O1|Outcome|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2 All subjects completed the intervention and phase I outcome measure.
961647|NCT00923273|E5|Reported Event|Treatment Level 5: 15mg Load|Sirolimus 15mg load/5mg/day; Pemetrexed 500mg/m^2
961648|NCT00923273|E4|Reported Event|Treatment Level 4: 10 mg Load|Sirolimus 10mg load/3mg/day; Pemetrexed 500mg/m^2
961649|NCT00923273|E3|Reported Event|Treatment Level 3: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 500mg/m^2
961650|NCT00923273|E2|Reported Event|Treatment Level 2: 6mg Load|Sirolimus 6mg load/2mg/day; Pemetrexed 375mg/m^2
961651|NCT00923273|E1|Reported Event|Treatment Level 1: 3mg Load|Sirolimus 3mg load/1mg/day; Pemetrexed 375mg/m^2
961652|NCT00923260|B3|Baseline|Total|Total of all reporting groups
961653|NCT00923260|B2|Baseline|Roux-en-Y Gastric Bypass Alone|
961654|NCT00923260|B1|Baseline|Roux-en-Y Gastric Bypass/Omentectomy|
961655|NCT00923260|P2|Participant Flow|Roux-en-Y Gastric Bypass Alone|
961656|NCT00923260|P1|Participant Flow|Roux-en-Y Gastric Bypass/Omentectomy|
961657|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961658|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961659|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961660|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961661|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961662|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961663|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961664|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961665|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961666|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961667|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961668|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961669|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961670|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961671|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961672|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961673|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961674|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961675|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961732|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961733|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961734|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961735|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961736|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961737|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961738|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961739|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961740|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961741|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961742|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961743|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961744|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961745|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961746|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961747|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961748|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961749|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961750|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961751|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961752|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961753|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961754|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961755|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961756|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961757|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961758|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961759|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961760|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961761|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961762|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961763|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961764|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961765|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961766|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961767|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961768|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961769|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961770|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961771|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961772|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961773|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961774|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961775|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961776|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961777|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961778|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961779|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961780|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961781|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961782|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961783|NCT00923260|O2|Outcome|Roux-en-Y Gastric Bypass Alone|
961784|NCT00923260|O1|Outcome|Roux-en-Y Gastric Bypass/Omentectomy|
961785|NCT00923260|E2|Reported Event|Roux-en-Y Gastric Bypass Alone|
961786|NCT00923260|E1|Reported Event|Roux-en-Y Gastric Bypass/Omentectomy|
961787|NCT00923247|B3|Baseline|Total|Total of all reporting groups
962331|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
961788|NCT00923247|B2|Baseline|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961789|NCT00923247|B1|Baseline|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961790|NCT00923247|P2|Participant Flow|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961791|NCT00923247|P1|Participant Flow|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961807|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961792|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961793|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961794|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961795|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961796|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961797|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961798|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961799|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961800|NCT00923247|O2|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961801|NCT00923247|O1|Outcome|Phase 1 - Vandetanib and Bortezomib|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961802|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961841|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
961803|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961804|NCT00923247|O2|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961805|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961806|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961808|NCT00923247|O2|Outcome|Phase 2A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961809|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961810|NCT00923247|O1|Outcome|Phase 2 A - Vandetanib and Bortezomib at the MTD|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose (MTD) of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961811|NCT00923247|O1|Outcome|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961812|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961813|NCT00923247|O1|Outcome|Phase 1|"Patients will be treated with vandetanib to find the maximally tolerated dose.~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib on days 1, 4, 8 & 11 every 28 days in adults"
961814|NCT00923247|E2|Reported Event|Phase 2 A|"Patients will be treated with vandetanib and bortezomib at the maximally tolerated dose of the Phase I study~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961815|NCT00923247|E1|Reported Event|Phase 1|"Patients will be treated with vandetanib and bortezomib to find the maximally tolerated dos~Bortezomib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults~Vandetanib: This study is designed to assess the safety, tolerance and activity of daily oral vandetanib and bortezomib on days 1, 4, 8 & 11 every 28 days in adults"
961816|NCT00923195|B3|Baseline|Total|Total of all reporting groups
961817|NCT00923195|B2|Baseline|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961842|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961861|NCT00923117|P2|Participant Flow|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
961818|NCT00923195|B1|Baseline|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961819|NCT00923195|P2|Participant Flow|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961847|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
962291|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
961820|NCT00923195|P1|Participant Flow|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961821|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961822|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961823|NCT00923195|O2|Outcome|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961824|NCT00923195|O1|Outcome|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961825|NCT00923195|E2|Reported Event|TBI 600cGy+PBL+HD IL-2+MART-1:26-35(27L)|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961826|NCT00923195|E1|Reported Event|TBI 600cGy + PBL + HD IL-2+gp100:154-162|"Day 0:Autologous transduced CD8+PBL (anti-gp100:154 TCR PBL and anti-MART-1 F5 TCR PBL) infusion will be administered intravenously over 20 to 30 minutes (minimum 5 x 10e8 and up to a maximum of 2 x 10e11 of each transduced lymphocyte population).~One mg of either the gp100:154-162 or the MART-1:26-35(27) emulsified in IFA by deep subcutaneous injection into each thigh to be administered prior to cell infusion and on days 7 and 14 Within 24 hours of cell infusion administration of aldesleukin will be initiated as 720,000 IU/kg/dose IV over 15 minutes every 8 hours for up to 5 days (maximum 15 doses).~Radiation: 2Gy of TBI twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute~Day -6 to -2: Fludarabine 25 mg/m2/day IVPB daily over 15-30 minutes for 5 days Day -6 to -5: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with mesna15 mg/kg/day over 1 hr X 2 days."
961827|NCT00923156|B4|Baseline|Total|Total of all reporting groups
961828|NCT00923156|B3|Baseline|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961829|NCT00923156|B2|Baseline|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
961830|NCT00923156|B1|Baseline|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961831|NCT00923156|P3|Participant Flow|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961832|NCT00923156|P2|Participant Flow|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
961833|NCT00923156|P1|Participant Flow|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961834|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961835|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961836|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961837|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961838|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961839|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961840|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961843|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961844|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
961845|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961846|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961848|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961849|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961850|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
961851|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961852|NCT00923156|O3|Outcome|Aliskiren Plus Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961853|NCT00923156|O2|Outcome|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
961854|NCT00923156|O1|Outcome|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961855|NCT00923156|E3|Reported Event|Ramipril + Aliskiren|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (period 2), patients received ramipril (10 mg once daily capsule) and aliskiren (150 mg once daily tablet) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site."
961856|NCT00923156|E2|Reported Event|Aliskiren|In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1. In double blind phase (Period 2), patients received aliskiren (150 mg once daily) up titrated to 300 mg once daily after 1 week of treatment following a clinical safety patient assessment at the study site and matching placebo of ramipril capsules.
961857|NCT00923156|E1|Reported Event|Ramipril|"In open label run-in phase (period 1), patients started with ramipril 2.5 mg or 5.0 mg capsule once daily (o.d) depending on previous treatment with RAAS blockers and up-titrated to ramipril 10 mg capsule o.d by end of period 1.~In double blind phase (Period 2), patients received ramipril 10 mg capsule o.d and matching placebo of aliskiren tablet."
961858|NCT00923117|B3|Baseline|Total|Total of all reporting groups
961859|NCT00923117|B2|Baseline|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
961860|NCT00923117|B1|Baseline|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
961862|NCT00923117|P1|Participant Flow|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab. Oral dose Sutent (sunitinib) 37.5 mg daily on a continuous 4 week cycle.
961863|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
961864|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
961865|NCT00923117|O2|Outcome|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
961866|NCT00923117|O1|Outcome|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
961867|NCT00923117|E2|Reported Event|Bevacizumab Naive Patients|Patients with progressive tumor who have not been treated with bevacizumab.
961868|NCT00923117|E1|Reported Event|Bevacizumab Resistant Patients|Patients who had tumor progression while treated with bevacizumab.
961869|NCT00923091|B9|Baseline|Total|Total of all reporting groups
961870|NCT00923091|B8|Baseline|Olmesartan/Amlodipine 40mg/10mg|
961871|NCT00923091|B7|Baseline|Olmesartan/Amlodipine 40mg/5mg|
961872|NCT00923091|B6|Baseline|Olmesartan/Amlodipine 20mg/5mg|
961873|NCT00923091|B5|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
961874|NCT00923091|B4|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
961875|NCT00923091|B3|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
961876|NCT00923091|B2|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
961877|NCT00923091|B1|Baseline|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
961921|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
962292|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
961878|NCT00923091|P13|Participant Flow|20/5/12.5mg Responder Continued on 20/5/12.5 mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg continued on 20mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
961879|NCT00923091|P12|Participant Flow|OM/AML/HCT 20/5/12.5mg NonResponder Up Titrated to 40/5/12.5mg|In Period V non-responders to olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5 mg were up titrated to 40mg/5mg/12.5mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
961880|NCT00923091|P11|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/25mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
961881|NCT00923091|P10|Participant Flow|OM/AML/HCT 40/5/12.5mg Non Responder Randomized to 40/5/12.5mg|In Period V OLM/AML/HCTZ 40/5/12.5 non-responders were randomized to olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5 mg or to 40mg/5mg/25 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
961882|NCT00923091|P9|Participant Flow|OM/AML/HCT 40/5/12.5mg Responder Continued on 40/5/12.5 mg|In Period V responders continued on olmesartan/amlodipine/ hydrochlorothiazide 40mg/5mg/12.5 mg. A participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease.
961883|NCT00923091|P8|Participant Flow|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
961884|NCT00923091|P7|Participant Flow|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
961885|NCT00923091|P6|Participant Flow|Olmesartan(OM)20mg/Amlodipine (AML)5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
961886|NCT00923091|P5|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide(HCT) 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
961887|NCT00923091|P4|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
961888|NCT00923091|P3|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion.
961889|NCT00923091|P2|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period IV participants who did not meet the blood pressure goals (<140/90 mm Hg; or <130/80 for participants with diabetes or chronic renal or cardiovascular disease)in Period III were randomized in a 1:2 fashion to OLM/AML/HCTZ 20/5/12.5 or this group.
961890|NCT00923091|P1|Participant Flow|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet. In Periods I/II participants were randomized to this and the other 7 arms arms in a 1:1:1:1:1:1:1:1 fashion. In Period III, all participants were included in this group. Responders (a participant was considered a responder if their blood pressure was <140/90 mm Hg; <130/80 mm Hg if the participant had diabetes or chronic renal or cardiovascular disease) in Period III went directly to Period VI. In Period IV participants who did not meet the blood pressure goals in Period III were randomized in a 1:2 fashion to this group or the OLM/AML/HCTZ 40/5/12.5 group.
961891|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/25 Titrated to 40/10/25|The participants in this arm had their study medication titrated from olmesartan\amlodipine\hydrochlorothiazide 40/5/25 to 40/10/25
961892|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
961893|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
961894|NCT00923091|O2|Outcome|OLM/AML/HCTZ40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
961895|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
961896|NCT00923091|O2|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/25|This arm contain participants who did not respond to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to 40/5/25 in Period V
961897|NCT00923091|O1|Outcome|OLM/AML/HCTZ 40/5/12.5mg Nonresponders Randomized to 40/5/12.5|This arm contain participants who did not responded to olmesartan\amlodipine\hydrochlorothiazide 40/5/12.5 and who were randomized to that combination in Period V
962138|NCT00922623|P1|Participant Flow|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
961898|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
961899|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
961900|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
961901|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
961902|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet.~Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
961903|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|"Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg.~hydrochlorothiazide placebo tablet. Participants from Period III who did not meet blood pressure goals (<140/90; 130/80 for participants with diabetes, chronic renal disease, or chronic cardiovascular disease)were randomized to Period IV in a 1:2 ratio to continue olm/aml/hctz 20/5/12.5 or be up-titrated to olm/aml/hctz 40/5/12.5."
961904|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961905|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961906|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961907|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
961908|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961909|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
961910|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961911|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961912|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961913|NCT00923091|O7|Outcome|Olmesartan/Amlodipine 40mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961914|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961915|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
961916|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961917|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
961918|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961919|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961920|NCT00923091|O8|Outcome|Olmesartan/Amlodipine 40mg/10mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961922|NCT00923091|O6|Outcome|Olmesartan/Amlodipine 20mg/5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + two 12.5 mg hydrochlorothiazide placebo tablets
961923|NCT00923091|O5|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 2 tablets of hydroclororthiazide 12.5 mg
961924|NCT00923091|O4|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 10 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961925|NCT00923091|O3|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 2 tablets of hydroclororthiazide 12.5 mg
961926|NCT00923091|O2|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|Once a day the following tablets were taken: 1 tablet of olmesartan 40 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961927|NCT00923091|O1|Outcome|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|Once a day the following tablets were taken: 1 tablet of olmesartan 20 mg/amlodipine 5 mg + 1 tablet of hydroclororthiazide 12.5 mg + one 12.5 mg hydrochlorothiazide placebo tablet
961928|NCT00923091|E8|Reported Event|Olmesartan/Amlodipine 40mg/10mg|
961929|NCT00923091|E7|Reported Event|Olmesartan/Amlodipine 40mg/5mg|
961930|NCT00923091|E6|Reported Event|Olmesartan/Amlodipine 20mg/5mg|
961931|NCT00923091|E5|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/25mg|
961932|NCT00923091|E4|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/10mg/12.5mg|
961933|NCT00923091|E3|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/25mg|
961934|NCT00923091|E2|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 40mg/5mg/12.5mg|
961935|NCT00923091|E1|Reported Event|Olmesartan/Amlodipine/Hydrochlorothiazide 20mg/5mg/12.5 mg|
961936|NCT00922987|B1|Baseline|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961937|NCT00922987|P1|Participant Flow|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961938|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961939|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961940|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961941|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961942|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961943|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961944|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961945|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961946|NCT00922987|O1|Outcome|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961947|NCT00922987|E1|Reported Event|Pregabalin|Pregabalin (Lyrica) at a dose ranging from 150 milligrams (mg) to 600 mg administered as two single doses, daily until Week 16.
961948|NCT00922935|B4|Baseline|Total|Total of all reporting groups
961949|NCT00922935|B3|Baseline|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
961950|NCT00922935|B2|Baseline|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
961951|NCT00922935|B1|Baseline|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
961952|NCT00922935|P3|Participant Flow|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
961953|NCT00922935|P2|Participant Flow|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
961954|NCT00922935|P1|Participant Flow|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
961955|NCT00922935|O3|Outcome|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
961956|NCT00922935|O2|Outcome|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
961957|NCT00922935|O1|Outcome|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
961958|NCT00922935|E3|Reported Event|Straumann System Late Loading|Straumann components loading at 6-8 weeks post surgery
961959|NCT00922935|E2|Reported Event|Cresco Late Loading|Healing caps will be placed until loading. The minimum waiting time is 4 weeks, but not before “try ins” to ensure a perfect fit. The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) within 42-56 days (6 to 8 weeks) of surgery.
961960|NCT00922935|E1|Reported Event|Cresco Early Loading|The implants must be restored (loaded) with a permanent screw retained fixed partial denture (FPD) at 10 days of post surgery
962293|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
961961|NCT00922779|B1|Baseline|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
961962|NCT00922779|P1|Participant Flow|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kilograms (kg) received dose of 400 milligrams (mg) (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with Peginterferon (PEG-INF) Alfa-2a 180 micrograms per milliliter (µg/mL) subcutaneous (SC) injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
961963|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
961964|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
961965|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
961966|NCT00922779|O1|Outcome|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
961967|NCT00922779|E1|Reported Event|Ribavirin + Peginterferon Alfa-2a|Participants with genotype 1 received ribavirin oral tablets daily depending on the body weight. Participants with body weight of less than 75 kg received dose of 400 mg (2 tablets of 200 mg) in morning and 600 mg (3 tablets of 200 mg) in evening, and participants with body weight of 75 kg or more, received dose of 600 mg (3 tablets of 200 mg) in the morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 48 weeks. Participants with other genotypes received ribavirin dose of 400 mg (2 tablets of 200 mg) in morning and evening along with PEG-INF Alfa-2a 180 µg/mL SC injection once weekly for 12 to 24 weeks.
961968|NCT00922766|B1|Baseline|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961969|NCT00922766|P1|Participant Flow|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961970|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961971|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961972|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961973|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961974|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961975|NCT00922766|O1|Outcome|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961976|NCT00922766|E1|Reported Event|Dalteparin|Dalteparin Sodium 120 international units/kilogram (IU/kg) total body weight up to a maximum dose of 10,000 IU subcutaneously (s.c.) every 12 hours, for 1-2 weeks.
961977|NCT00922701|B1|Baseline|Peritoneal Dialysis Solution|The enrolled patients were using for the long dwell (nocturnal) exchange a glucose-based (2.5% w/v) peritoneal dialysis solution.
961978|NCT00922701|P1|Participant Flow|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
962294|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
961979|NCT00922701|O1|Outcome|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
961980|NCT00922701|E1|Reported Event|Peritoneal Dialysis Solution|Patients were treated with a glucose-based (1.5% weight/volume) peritoneal dialysis solution containing L-carnitine (0.25% weight/volume) for the long dwell. Peritoneal dialysis solution was instilled for 5 days.
961981|NCT00922636|B6|Baseline|Total|Total of all reporting groups
961982|NCT00922636|B5|Baseline|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961983|NCT00922636|B4|Baseline|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961984|NCT00922636|B3|Baseline|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961985|NCT00922636|B2|Baseline|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
961986|NCT00922636|B1|Baseline|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
961987|NCT00922636|P5|Participant Flow|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961988|NCT00922636|P4|Participant Flow|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961989|NCT00922636|P3|Participant Flow|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961990|NCT00922636|P2|Participant Flow|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
961991|NCT00922636|P1|Participant Flow|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
961992|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
961993|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961994|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961995|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961996|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
961997|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
961998|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
961999|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962000|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962001|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962139|NCT00922623|O2|Outcome|Belotero, Right Nasolabial Fold|Belotero injected into the Right Nasolabial Fold of the Face
962002|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962003|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962004|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962005|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962006|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962007|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962008|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962009|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962010|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962011|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962012|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962013|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962014|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962015|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962016|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962017|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962018|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
965054|NCT00912795|B3|Baseline|Total|Total of all reporting groups
962019|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962020|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962021|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962022|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962023|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962024|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962025|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962026|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962027|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962028|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962029|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962030|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962031|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962032|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962033|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962034|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962035|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962036|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962037|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962038|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962039|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962040|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962205|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962041|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962042|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962043|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962044|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962045|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962046|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962047|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962048|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962049|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962050|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962051|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962052|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962053|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962054|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962055|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962056|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962057|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962058|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962059|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962060|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962061|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962062|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
963040|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
962063|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962064|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962065|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962066|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962067|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962068|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962069|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962070|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962071|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962072|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962073|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962074|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962075|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962076|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962077|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962078|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962079|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962080|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962081|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962082|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962083|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962084|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962085|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962086|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962087|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962088|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962089|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962286|NCT00921947|B2|Baseline|VAX102 SC|Given as 2 µg subcutaneous
962090|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962091|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962092|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962093|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962094|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962095|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962096|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962097|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962098|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962099|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962100|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962101|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962102|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962103|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962104|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962105|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962106|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962332|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962107|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962108|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962109|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962110|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962111|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962112|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962113|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962114|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962115|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962116|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962117|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962118|NCT00922636|O1|Outcome|Methylphenidate|Participants were given 18 milligrams per day (mg/day) to 54 mg/day of extended-release methylphenidate capsules, based on weight, once daily (QD) and orally (po) for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo tablets to maintain LY2216684 blinding during the double-blind treatment phase.
962119|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962120|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962121|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962122|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962123|NCT00922636|O4|Outcome|LY2216684 (0.3 mg/kg/Day)|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962124|NCT00922636|O3|Outcome|LY2216684 (0.2 mg/kg/Day)|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of tapering in optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962125|NCT00922636|O2|Outcome|LY2216684 (0.1 mg/kg/Day)|Participants were given 0.1 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962126|NCT00922636|O1|Outcome|Placebo|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase, followed by 2 weeks of placebo in the optional taper phase.
962127|NCT00922636|E10|Reported Event|Methylphenidate - Taper Phase|Participants were given the placebo in capsule form QD po for the 2-week taper phase.
962128|NCT00922636|E9|Reported Event|LY2216684 (0.3 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
962129|NCT00922636|E8|Reported Event|LY2216684 (0.2 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in taper phase.
962130|NCT00922636|E7|Reported Event|LY2216684 (0.1 mg/kg/Day) - Taper Phase|Participants were given the reduced dose of LY2216684 in tablet form QD po for 2 weeks of tapering in the taper phase.
962131|NCT00922636|E6|Reported Event|Placebo - Taper Phase|Methylphenidate blind: Participants were given the placebo in capsule form QD po for the 2-week taper phase.
962132|NCT00922636|E5|Reported Event|Methylphenidate - Treatment Phase|Participants were given 18 mg/day to 54 mg/day of extended-release methylphenidate capsules, based on weight QD po for the 8-week double-blind treatment phase. Participants were also given placebo tablets to maintain LY2216684 blinding.
962133|NCT00922636|E4|Reported Event|LY2216684 (0.3 mg/kg/Day) - Treatment Phase|Participants were given 0.3 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962134|NCT00922636|E3|Reported Event|LY2216684 (0.2 mg/kg/Day) - Treatment Phase|Participants were given 0.2 mg/kg/day of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962135|NCT00922636|E2|Reported Event|LY2216684 (0.1 mg/kg/Day) - Treatment Phase|Participants were given 0.1 milligrams per kilogram per day (mg/kg/day) of LY2216684 in tablet form QD po for the 8-week double-blind treatment phase. Participants were also given placebo capsules to maintain methylphenidate blinding.
962136|NCT00922636|E1|Reported Event|Placebo - Treatment Phase|Participants were given the placebo in both tablet (LY2216684 placebo) and capsule (methylphenidate placebo) forms QD po for the 8-week double-blind treatment phase.
962137|NCT00922623|B1|Baseline|Belotero®|Belotero® injection into both nasolabial folds of Fitzpatrick IV, V, VI subjects.
962287|NCT00921947|B1|Baseline|VAX102 IM|Given as 1 µg intramuscular
962140|NCT00922623|O1|Outcome|Belotero, Left Nasolabial Fold|Belotero injected into the Left Nasolabial Fold of the Face
962141|NCT00922623|E2|Reported Event|Belotero, Right Nasolabial Fold|
962142|NCT00922623|E1|Reported Event|Belotero, Left Nasolabial Fold|
962143|NCT00922428|B1|Baseline|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
962144|NCT00922428|P1|Participant Flow|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
962145|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
962146|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
962147|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
962148|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
962149|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
962150|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
962151|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
962152|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
962153|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
962154|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
962155|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
962156|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
962157|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
962158|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
962159|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
962160|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
962161|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
962162|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
962163|NCT00922428|O3|Outcome|Observational Group (V2/V3)|Improvement in % between Visit 2 and Visit 3
962164|NCT00922428|O2|Outcome|Observational Group (V1/V3)|Improvement in % between Visit 1 and Visit 3
962165|NCT00922428|O1|Outcome|Observational Group (V1/V2)|Improvement in % between Visit 1 and Visit 2
962166|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
962167|NCT00922428|O1|Outcome|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
962168|NCT00922428|O3|Outcome|Observational Group (Visit 3)|VAS of the observational group at visit 3
962169|NCT00922428|O2|Outcome|Observational Group (Visit 2)|VAS of the observational group at visit 2
962170|NCT00922428|O1|Outcome|Observational (Visit 1)|VAS of the observational group at beginning
962171|NCT00922428|E1|Reported Event|Observational Group|Patients suffering from rheumatic disorders of different types and origins, especially those with arthralgia, myalgia, lumbago, or other diagnoses.
962172|NCT00922272|B1|Baseline|Overall|Constitutes all subjects contained in the Safety Analysis Set defined as all subjects who took at least 1 dose of open-label investigational product and for whom at least 1 follow-up safety assessment was made.
962173|NCT00922272|P2|Participant Flow|Placebo|Subjects received placebo once-daily for 4 weeks during the Double-blind Phase to a stable dose of atypical antipsychotic medication.
962174|NCT00922272|P1|Participant Flow|SPD489|The study consisted of a 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication. They were then randomized into the Double-Blind Phase receiving either their optimal dose of adjunctive SPD489 or placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962175|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962333|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962176|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962177|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962178|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962179|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962180|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962181|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962182|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962288|NCT00921947|P2|Participant Flow|VAX102 SC|Given as 2 µg subcutaneous
962183|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962184|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962185|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962186|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962187|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962188|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962189|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962190|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962191|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962192|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962193|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962194|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962195|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962196|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962197|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962198|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962199|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962200|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962201|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962202|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962203|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962204|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962206|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962207|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962208|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962209|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962210|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962211|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962212|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962213|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962214|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962215|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962216|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962217|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962218|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962219|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962220|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962221|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962222|NCT00922272|O2|Outcome|Placebo (Double-blind Phase)|Subjects receive placebo once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962223|NCT00922272|O1|Outcome|SPD489 (Double-blind Phase)|Subjects receive optimal dose (20, 30, 40, 50, 60 or 70 mg) of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily for 4 weeks to a stable dose of atypical antipsychotic medication.
962224|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962225|NCT00922272|O1|Outcome|SPD489 (Open-label Phase)|A 10-week Open-label Phase (7-week Dose Optimization Period and a 3-week Dose maintenance Period) in which subjects received 20, 30, 40, 50, 60 or 70 mg of adjunctive SPD489 (Lisdexamfetamine dimesylate) once-daily to a stable dose of atypical antipsychotic medication.
962226|NCT00922272|E3|Reported Event|Placebo (Double-blind Phase)|Subjects receive placebo once-daily
962227|NCT00922272|E2|Reported Event|SPD489 (Double-blind Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
962228|NCT00922272|E1|Reported Event|SPD489 (Open-label Phase)|Subjects receive either 20, 30, 40, 50, 60 or 70 mg of SPD489 (Lisdexamfetamine dimesylate) once-daily
962229|NCT00922233|B1|Baseline|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills (levonorgestrel) : oral contraceptive pills
962230|NCT00922233|P1|Participant Flow|Levonorgestrel|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
962231|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
962232|NCT00922233|O1|Outcome|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
962233|NCT00922233|O1|Outcome|Levonorgestrel|0.75 mg levonorgestrel oral contraceptive pills
962234|NCT00922233|E1|Reported Event|Levonorgestrel Arm|Only one study arm. All women were assigned to take 0.75 mg oral contraceptive pills (levonorgestrel) within 24 hours of engaging in sex.
962235|NCT00922207|B4|Baseline|Total|Total of all reporting groups
962236|NCT00922207|B3|Baseline|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962334|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962237|NCT00922207|B2|Baseline|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962238|NCT00922207|B1|Baseline|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962239|NCT00922207|P3|Participant Flow|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962240|NCT00922207|P2|Participant Flow|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir (Baraclude) 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962289|NCT00921947|P1|Participant Flow|VAX102 IM|Given as 1 µg intramuscular
962290|NCT00921947|O2|Outcome|VAX102 2.0 µg s.c.|
962241|NCT00922207|P1|Participant Flow|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir (Hepsera) 10 milligrams (mg) tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peginterferon alfa-2a (peg-IFN-alfa-2a; Pegasys) 180 micrograms (µg) subcutaneous (SC) injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962242|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962243|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962244|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962245|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962246|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962247|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962248|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962249|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962250|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962251|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962252|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962253|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962279|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962254|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962255|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962256|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962257|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962258|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962259|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962260|NCT00922207|O3|Outcome|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962261|NCT00922207|O2|Outcome|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962262|NCT00922207|O1|Outcome|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962263|NCT00922207|E3|Reported Event|Peg-IFN-Alfa-2a + Placebo|Participants received placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by placebo matched to adefovir tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962264|NCT00922207|E2|Reported Event|Peg-IFN-Alfa-2a + Entecavir|Participants received entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily for 4 weeks, followed by entecavir 0.5 mg tablet and placebo matched to adefovir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962265|NCT00922207|E1|Reported Event|Peg-IFN-Alfa-2a + Adefovir|Participants received adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily for 4 weeks, followed by adefovir 10 mg tablet and placebo matched to entecavir tablet, orally once daily and peg-IFN-alfa-2a 180 µg SC injection once per week, for 2 weeks and then peg-IFN-alfa-2a 180 µg SC injection once per week for 46 weeks.
962266|NCT00922194|B1|Baseline|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962267|NCT00922194|P1|Participant Flow|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962268|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962269|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962270|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962271|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962272|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962273|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962274|NCT00922194|O1|Outcome|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962275|NCT00922194|E1|Reported Event|Overweight Type 2 Diabetes Mellitus|One arm study in Overweight Type 2 Diabetes Mellitus
962276|NCT00922116|B1|Baseline|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962277|NCT00922116|P1|Participant Flow|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 micrograms [mcg] (based on previous erythropoiesis stimulating agent therapy) administered via subcutaneous (SC) injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962278|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962330|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962280|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962281|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962282|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962283|NCT00922116|O1|Outcome|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962284|NCT00922116|E1|Reported Event|Mircera|Participants received Mircera (methoxy polyethylene glycol epoetin beta) at a starting dose of 120, 200 or 360 mcg (based on previous erythropoiesis stimulating agent therapy) administered via SC injection once monthly for 24 weeks. Doses were titrated based on hemoglobin levels.
962285|NCT00921947|B3|Baseline|Total|Total of all reporting groups
962295|NCT00921947|O1|Outcome|VAX102 1.0 µg i.m.|
962296|NCT00921947|E2|Reported Event|VAX102 SC|Given as 2 µg subcutaneous
962297|NCT00921947|E1|Reported Event|VAX102 IM|Given as 1 µg intramuscular
962298|NCT00921934|B1|Baseline|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
962299|NCT00921934|P1|Participant Flow|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
962300|NCT00921934|O1|Outcome|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
962301|NCT00921934|E1|Reported Event|Vitamin C|Adult patients suffering from acute viral infection, especially herpes zoster, presenting themselves in Primary Care Centers or hospitals all over Germany, and who are treated with standard therapy and add-on vitamin C.
962302|NCT00921895|B1|Baseline|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
962303|NCT00921895|P1|Participant Flow|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
962304|NCT00921895|O2|Outcome|RPS Adeno Detector IV (Specificity)|Looking for the number of true negatives as compared to cell culture.
962305|NCT00921895|O1|Outcome|RPS Adeno Detector IV (Sensitivity)|Looking for the number of true positives as compared to cell culture.
962306|NCT00921895|E1|Reported Event|Device Testing|Patients with conjunctivitis will be tested with the RPS Adeno Detector IV
962307|NCT00921687|B3|Baseline|Total|Total of all reporting groups
962308|NCT00921687|B2|Baseline|Intervention Clinic|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
962309|NCT00921687|B1|Baseline|Control Clinic|Providers in the control group received education only (chronic kidney disease (CKD) lecture and a CKD reference card).
962310|NCT00921687|P2|Participant Flow|Intervention|The multifactorial intervention consisted of a CKD lecture, the CKD reference card, academic detailing, and access to the CKD registry.
962311|NCT00921687|P1|Participant Flow|Control|Providers in the control group received education only (CKD lecture and a CKD reference card).
962312|NCT00921687|O2|Outcome|Intervention Clinic|
962313|NCT00921687|O1|Outcome|Control Clinic|
962314|NCT00921687|O2|Outcome|Intervention Clinic|
962315|NCT00921687|O1|Outcome|Control Clinic|
962316|NCT00921687|E2|Reported Event|Intervention Clinic|
962317|NCT00921687|E1|Reported Event|Control Clinic|
962318|NCT00921557|B4|Baseline|Total|Total of all reporting groups
962319|NCT00921557|B3|Baseline|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962320|NCT00921557|B2|Baseline|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962321|NCT00921557|B1|Baseline|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962322|NCT00921557|P3|Participant Flow|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962323|NCT00921557|P2|Participant Flow|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962324|NCT00921557|P1|Participant Flow|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962325|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962326|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962327|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962328|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962329|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962335|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962336|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962337|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962338|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962339|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962340|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962341|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962342|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962343|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962344|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962345|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962346|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962347|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962348|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962349|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962350|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962351|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
964571|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
962352|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962353|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962354|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962355|NCT00921557|O3|Outcome|1B: Alendronate/Placebo (96 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
962356|NCT00921557|O2|Outcome|2: Placebo/Alendronate (48 Week Change)|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962357|NCT00921557|O1|Outcome|1B: Alendronate/Placebo (48 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
962358|NCT00921557|O3|Outcome|1B: Alendronate/Placebo (96 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
962359|NCT00921557|O2|Outcome|2: Placebo/Alendronate (48 Week Change)|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962360|NCT00921557|O1|Outcome|1B: Alendronate/Placebo (48 Week Change)|Participants received alendronate for 48 weeks followed by placebo for 48 weeks.
962361|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
962362|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
962363|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
962364|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
962365|NCT00921557|O3|Outcome|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962366|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962367|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962368|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962369|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962370|NCT00921557|O2|Outcome|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962371|NCT00921557|O1|Outcome|1A: Alendronate/Alendronate|Participants received alendronate for 96 weeks
962372|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
962373|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
962374|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
962375|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
962376|NCT00921557|O2|Outcome|2: Placebo|Participants received placebo for 48 weeks
962377|NCT00921557|O1|Outcome|1: Alendronate|Participants received alendronate for 48 weeks
962378|NCT00921557|E3|Reported Event|2: Placebo/Alendronate|Participants received placebo for 48 weeks followed by alendronate for 48 weeks
962379|NCT00921557|E2|Reported Event|1B: Alendronate/Placebo|Participants received alendronate for 48 weeks followed by placebo for 48 weeks
962380|NCT00921557|E1|Reported Event|1A: Alendronate/Alendronate|Participants received alendronate for 48 weeks
962381|NCT00921518|B3|Baseline|Total|Total of all reporting groups
962382|NCT00921518|B2|Baseline|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962402|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962584|NCT00920647|B2|Baseline|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962585|NCT00920647|B1|Baseline|Control|Untreated Patients
962383|NCT00921518|B1|Baseline|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962384|NCT00921518|P2|Participant Flow|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962385|NCT00921518|P1|Participant Flow|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962410|NCT00921310|O3|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962411|NCT00921310|O2|Outcome|Phase 1 Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
964572|NCT00914186|O1|Outcome|Vehicle|once daily
962386|NCT00921518|O2|Outcome|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962387|NCT00921518|O1|Outcome|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962388|NCT00921518|E2|Reported Event|Sodium Bicarbonate|"This arm two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~Sodium Bicarbonate: Group two will receive sodium bicarbonate 150mEq in 850ml of a 5% dextrose solution at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962389|NCT00921518|E1|Reported Event|Normal Saline|"This group will receive isotonic saline at 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass.~0.9% Sodium Chloride (Placebo): 3 ml/kg/hr for one hour pre-operatively until the patient is started on cardiopulmonary bypass. Then the infusion will be reduced to 1 ml/kg/hr throughout cardiopulmonary bypass and for six hours following cardiopulmonary bypass."
962390|NCT00921310|B3|Baseline|Total|Total of all reporting groups
962391|NCT00921310|B2|Baseline|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962392|NCT00921310|B1|Baseline|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962393|NCT00921310|P3|Participant Flow|Phase 2 (Pemetrexed & Temsirolimus)|"Phase 2 dose will be the maximum tolerated dose found in the Phase I portion of the study.~Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962394|NCT00921310|P2|Participant Flow|Phase I Dose Level -1 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962395|NCT00921310|P1|Participant Flow|Phase I Dose Level 1 (Pemetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962396|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962397|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962398|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962399|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962400|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962401|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962403|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962404|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962405|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962406|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962407|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962408|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962409|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962412|NCT00921310|O1|Outcome|Phase I Dose Level 1 (Premetrexed & Temsirolimus)|"Pemetrexed 500mg/m^2 intravenous (IV) on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962413|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962414|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962415|NCT00921310|O2|Outcome|Phase 2 (Pemetrexed & Temsirolimus)|"-Participants enrolled in the Phase 2 portion received:~Pemetrexed (375 mg/m2^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962416|NCT00921310|O1|Outcome|Phase I (Premetrexed & Temsirolimus)|"Participants enrolled in the Phase I portion Dose Level 1 received:~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Participants enrolled in the Phase I portion Dose Level -1 received:~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962417|NCT00921310|E2|Reported Event|Phase 2 (Pemetrexed & Temsirolimus)|"Pemetrexed (375 mg/m^2) IV on Day 1 of each 21 day cycle~Temsirolimus (15 mg) IV on Days 1,8 and 15 of each 21 day cycle"
962418|NCT00921310|E1|Reported Event|Phase I (Premetrexed & Temsirolimus)|"Dose Level 1~Pemetrexed 500mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle~Dose Level -1~Pemetrexed 375mg/m^2 IV on Day 1 of each 21 day cycle~Temsirolimus 15 mg IV on Days 1,8 and 15 of each 21 day cycle"
962419|NCT00921115|B1|Baseline|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
962420|NCT00921115|P1|Participant Flow|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
962421|NCT00921115|O1|Outcome|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
963041|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
962422|NCT00921115|E1|Reported Event|Arimidex + Faslodex|"Patients will have an Oncotype Dx performed and if the RS is <25, they will receive Anastrazole and Fulvestrant for 16 weeks.~On day 28, subjects will be evaluated for side effects and a needle core biopsy (optional) will be obtained. Response evaluation will occur every 28 days. All treatment will continue for 4 months followed by breast surgery. After surgery, patients will be off study and will receive additional breast cancer therapy per their treating physician. Patients who develop progressive disease on protocol will be removed from the study and treated by their treating physician. The protocol will be closed after the last accrued patient has had surgery.~Fulvestrant: Fulvestrant IM on day 14 and on day 28 followed by day 28 of all subsequent cycles thereafter. Treatment will be continued for a total of 4 cycles.~Anastrazole: Anastrazole, 1mg by mouth every day of all 28 day cycles and continued for a total of 4 cycles"
962423|NCT00921024|B3|Baseline|Total|Total of all reporting groups
962424|NCT00921024|B2|Baseline|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
962425|NCT00921024|B1|Baseline|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
962426|NCT00921024|P2|Participant Flow|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
962427|NCT00921024|P1|Participant Flow|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
962428|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
962429|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
962430|NCT00921024|O2|Outcome|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
962431|NCT00921024|O1|Outcome|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
962432|NCT00921024|E2|Reported Event|Ceftazidime|Ceftazidime: intravenous 1000 mg every 8 hours
962433|NCT00921024|E1|Reported Event|CXA-101|CXA-101: intravenous 1000 mg every 8 hours
962434|NCT00920907|B3|Baseline|Total|Total of all reporting groups
962599|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD.
964573|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
962435|NCT00920907|B2|Baseline|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962436|NCT00920907|B1|Baseline|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962437|NCT00920907|P2|Participant Flow|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962438|NCT00920907|P1|Participant Flow|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
962439|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962440|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962441|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962442|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962443|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962444|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962445|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962446|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962447|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962579|NCT00920686|E2|Reported Event|NXN-188|600 mg NXN-188. Three capsules each containing 200 mg of NXN-188 were provided. All capsules were taken at the same time.
962448|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962449|NCT00920907|O2|Outcome|Ipilimumab (Process C)|Intravenous (IV) solution of 10 milligrams (mg)ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962450|NCT00920907|O1|Outcome|Ipilimumab (Process B)|Intravenous (IV) solution of 10 milligrams (mg) ipilimumab per kilogram (kg) of body weight was given once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by the Lonza company using material from transfectoma cell line.
962451|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962452|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962600|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
964574|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
962453|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962454|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962455|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962456|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962457|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962458|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962459|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962460|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962461|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962462|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962463|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962464|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962465|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962466|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962580|NCT00920686|E1|Reported Event|Placebo|Three placebo capsules were provided. All capsules were taken at the same time.
962467|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962468|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962469|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962470|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962471|NCT00920907|O2|Outcome|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962784|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
962472|NCT00920907|O1|Outcome|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962473|NCT00920907|E2|Reported Event|Ipilimumab (Process C)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process C, ipilimumab was manufactured by the Sponsor using material from a sub-clone of the original transfectoma cell line, modified cell culture and purification steps.
962474|NCT00920907|E1|Reported Event|Ipilimumab (Process B)|10 mg/kg ipilimumab was given IV once every 3 weeks (up to 4 doses) in the induction phase (Weeks 1, 4, 7, and 10); it was given once every 12 weeks in the maintenance phase for 48 weeks. In Process B, ipilimumab was manufactured by Lonza using material from transfectoma cell line.
962475|NCT00920855|B4|Baseline|Total|Total of all reporting groups
962476|NCT00920855|B3|Baseline|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962477|NCT00920855|B2|Baseline|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962478|NCT00920855|B1|Baseline|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962479|NCT00920855|P3|Participant Flow|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962480|NCT00920855|P2|Participant Flow|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962481|NCT00920855|P1|Participant Flow|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962482|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962483|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962484|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962485|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
962486|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
962487|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
962488|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
962489|NCT00920855|O1|Outcome|Bendamustine and Bortezomib - Overall|Bendamustine in escalating doses of 50, 70 or 90 mg/m^2 as combination therapy with bortezomib at 1.0 mg/m^2/dose administered for up to eight 28 day cycles. Participants whose disease has not progressed at the end of the eight cycles will be followed until disease progression or death.
962490|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962491|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962492|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962493|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962494|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962495|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962496|NCT00920855|O3|Outcome|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962497|NCT00920855|O2|Outcome|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962498|NCT00920855|O1|Outcome|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962499|NCT00920855|E3|Reported Event|Bendamustine 90 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 90 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
964575|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
962500|NCT00920855|E2|Reported Event|Bendamustine 70 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 70 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962501|NCT00920855|E1|Reported Event|Bendamustine 50 mg/m^2 Cohort|Bortezomib 1.0 mg/m^2/dose (days 1, 4, 8 and 11) by intravenous push and Bendamustine 50 mg/m^2/dose (days 1 and 4) intravenously for up to eight 28 day cycles.
962502|NCT00920816|B5|Baseline|Total|Total of all reporting groups
962503|NCT00920816|B4|Baseline|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962504|NCT00920816|B3|Baseline|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962505|NCT00920816|B2|Baseline|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962506|NCT00920816|B1|Baseline|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962507|NCT00920816|P4|Participant Flow|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962508|NCT00920816|P3|Participant Flow|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962509|NCT00920816|P2|Participant Flow|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962510|NCT00920816|P1|Participant Flow|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 milligram (mg) orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962511|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962512|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962513|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962514|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962515|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962581|NCT00920647|B5|Baseline|Total|Total of all reporting groups
962582|NCT00920647|B4|Baseline|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962516|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962517|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962518|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962519|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962520|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
964576|NCT00914186|O1|Outcome|Vehicle|once daily
962521|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962522|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962523|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962524|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962525|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962526|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962527|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962528|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962529|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962530|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962531|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962532|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962533|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962534|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962535|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962583|NCT00920647|B3|Baseline|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962536|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962537|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962538|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962539|NCT00920816|O2|Outcome|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962540|NCT00920816|O1|Outcome|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
964577|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
962541|NCT00920816|O2|Outcome|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962542|NCT00920816|O1|Outcome|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962543|NCT00920816|E4|Reported Event|Sorafenib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962544|NCT00920816|E3|Reported Event|Axitinib (Second-line Participants)|Asian participants with prior systemic first-line therapy containing sunitinib or cytokine received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962545|NCT00920816|E2|Reported Event|Sorafenib (First-line Participants)|Participants with no prior systemic first-line therapy received sorafenib tablet at a starting dose of 400 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962546|NCT00920816|E1|Reported Event|Axitinib (First-line Participants)|Participants with no prior systemic first-line therapy received axitinib (AG-013736) tablet at a starting dose of 5 mg orally twice daily, dose adjustment was done based on the tolerability, as per investigator’s discretion. Study medication was administered in cycles of 4 weeks.
962547|NCT00920790|B1|Baseline|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962548|NCT00920790|P1|Participant Flow|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962549|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962550|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962551|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962552|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962553|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962554|NCT00920790|O1|Outcome|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962555|NCT00920790|E1|Reported Event|KW-0761|IV infusions of KW-0761 once/week for 8 weeks at a dose of 1.0mg/kg
962556|NCT00920686|B4|Baseline|Total|Total of all reporting groups
962557|NCT00920686|B3|Baseline|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
962558|NCT00920686|B2|Baseline|NXN-188 600 mg|3 x 200 mg capsules
962559|NCT00920686|B1|Baseline|Placebo|3 x 0 mg capsules
962560|NCT00920686|P3|Participant Flow|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
962561|NCT00920686|P2|Participant Flow|NXN-188 600 mg|3 x 200 mg capsules
962562|NCT00920686|P1|Participant Flow|Placebo|3 x 0 mg capsules
962563|NCT00920686|O3|Outcome|Sumatriptan Succinate|1 x 100 mg, 2 x 0 mg capsules
962564|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
962565|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
962566|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
962567|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
962568|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
962569|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
962570|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
962571|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
962572|NCT00920686|O3|Outcome|Sumatriptan Succinate 100 mg|1 x 100 mg, 2 x 0 mg capsules
962573|NCT00920686|O2|Outcome|NXN-188 600 mg|3 x 200 mg capsules
962574|NCT00920686|O1|Outcome|Placebo|3 x 0 mg capsules
962575|NCT00920686|O3|Outcome|Sumatriptan Succinate|100 mg of sumatriptan succinate provided as 1 capsule containing 100 mg of sumatriptan and 2 capsules containing placebo
962576|NCT00920686|O2|Outcome|NXN-188|600 mg of NXN-188 provided as 3 x 200 mg capsules.
962577|NCT00920686|O1|Outcome|Placebo|Three capsules containing placebo
962578|NCT00920686|E3|Reported Event|Sumatriptan Succinate|100 mg sumatriptan. Three capsules, one containing 100 mg sumatriptan succinate and two placebo-containing capsules were provided. All capsules were taken at the same time.
962586|NCT00920647|P4|Participant Flow|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962587|NCT00920647|P3|Participant Flow|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962588|NCT00920647|P2|Participant Flow|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962589|NCT00920647|P1|Participant Flow|Control|Untreated Patients
962590|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962591|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962592|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962593|NCT00920647|O1|Outcome|Control|Untreated Patients, Observed Value
962594|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 36 hours post drug administration"
962595|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 24 hours post drug administration"
962596|NCT00920647|O1|Outcome|Idursulfase IT (1 mg)|"monthly using an intrathecal drug delivery device (IDDD)~Value represents concentration at 36 hours post drug administration."
962597|NCT00920647|O3|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962598|NCT00920647|O2|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
964578|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
962601|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962602|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962603|NCT00920647|O1|Outcome|Control|Untreated Patients
962604|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962605|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962606|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962607|NCT00920647|O1|Outcome|Control|Untreated Patients
962608|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962609|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962610|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962611|NCT00920647|O1|Outcome|Control|Untreated Patients
962612|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962613|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962614|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962615|NCT00920647|O1|Outcome|Control|Untreated Patients
962616|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962617|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962618|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962619|NCT00920647|O1|Outcome|Control|
962620|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962621|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962622|NCT00920647|O2|Outcome|Idursulfase IT (1mg)|monthly using an intrathecal drug delivery device (IDDD)
962623|NCT00920647|O1|Outcome|Control|Untreated Patients
962624|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962625|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962626|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962627|NCT00920647|O1|Outcome|Control|Untreated Patients for 6 months, Observed Value
962628|NCT00920647|O4|Outcome|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962629|NCT00920647|O3|Outcome|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962630|NCT00920647|O2|Outcome|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962631|NCT00920647|O1|Outcome|Control|Untreated Patients
962632|NCT00920647|E4|Reported Event|Idursulfase IT (30 mg)|monthly using an intrathecal drug delivery device (IDDD)
962633|NCT00920647|E3|Reported Event|Idursulfase IT (10 mg)|monthly using an intrathecal drug delivery device (IDDD)
962634|NCT00920647|E2|Reported Event|Idursulfase IT (1 mg)|monthly using an intrathecal drug delivery device (IDDD)
962635|NCT00920647|E1|Reported Event|Control|Untreated Patients
962636|NCT00920374|B3|Baseline|Total|Total of all reporting groups
962637|NCT00920374|B2|Baseline|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962638|NCT00920374|B1|Baseline|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962639|NCT00920374|P2|Participant Flow|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962640|NCT00920374|P1|Participant Flow|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962641|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962642|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962643|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962644|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962645|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962646|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962647|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962648|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962649|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962650|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962651|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962652|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962653|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962654|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962655|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962656|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962657|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962658|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962659|NCT00920374|O2|Outcome|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962660|NCT00920374|O1|Outcome|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962661|NCT00920374|E2|Reported Event|Fluarix Elderly Group|Subjects who are > 60 years of age received one dose of Fluarix™
962662|NCT00920374|E1|Reported Event|Fluarix Adult Group|Subjects who are 18-60 years of age received one dose of Fluarix™
962663|NCT00920309|B3|Baseline|Total|Total of all reporting groups
962664|NCT00920309|B2|Baseline|Standard of Care-Placebo|
962665|NCT00920309|B1|Baseline|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
962666|NCT00920309|P2|Participant Flow|Standard of Care-Placebo|
962667|NCT00920309|P1|Participant Flow|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
962668|NCT00920309|O2|Outcome|Standard of Care-Placebo|
962669|NCT00920309|O1|Outcome|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
962670|NCT00920309|O2|Outcome|Standard of Care-Placebo|
962671|NCT00920309|O1|Outcome|Rapamycin|The study was terminated before any enrolled patients were treated for 2 years.
962672|NCT00920309|E2|Reported Event|Standard of Care-Placebo|
962673|NCT00920309|E1|Reported Event|Rapamycin|"Drug: Rapamycin~Other Names:~sirolimus The starting dose of rapamycin will be 1 mg daily. The dose will be increased as needed to achieve a 24 hour trough level of 4-6 ng/ml."
962674|NCT00920231|B3|Baseline|Total|Total of all reporting groups
962675|NCT00920231|B2|Baseline|Modified System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
962676|NCT00920231|B1|Baseline|Initial System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
962677|NCT00920231|P2|Participant Flow|Modified Computer Vision System|"a second group of 8 blind subjects were tested with a modified computer vision system.~same task as the initial group with improved computer vision algorithm."
962678|NCT00920231|P1|Participant Flow|Initial Computer Vision System|"a group of 8 blind subjects were tested with a prototype computer vision system build for outdoor navigation that relied on combination of GPS and location recognition for navigation information.~the task was a wayfinding task starting from one point in the hospital and go to a point at another point in the hospital while navigating negotiating a number of turns over multiple corridors."
962679|NCT00920231|O2|Outcome|Modified System|this computer vision system incorporates the needed changes identified by the first group of subjects using the initial prototype system.
962680|NCT00920231|O1|Outcome|Initial Prototype|The initial prototype is a system that has been successfully tested in outdoor navigation and successfully tested for simple object recognition.
962681|NCT00920231|O2|Outcome|Modified System|a second group of 8 subjects were tested with a system that incorporated modifications identified by the first group using the initial prototype system.
962682|NCT00920231|O1|Outcome|Initial System|The subjects were asked to travel over a novel path in the hospital after given instructions how to reach the final destination. the computer vision system was used to provide additional information as when to turn and in what direction. the subjects were allowed to also use their white cane
962683|NCT00920231|E2|Reported Event|Arm 2|"The subject without the assist device can only locate the object by groping and random searching with hands.~No adverse events"
962684|NCT00920231|E1|Reported Event|Arm 1|"the blind subject is asked to locate a randomly placed object with the assistance of the webcam/laptop computer.~computer vision: a webcam-laptop based system to assist the blind in locating objects and in way finding.~No adverse events"
962685|NCT00920140|B6|Baseline|Total|Total of all reporting groups
962686|NCT00920140|B5|Baseline|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
962687|NCT00920140|B4|Baseline|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
962688|NCT00920140|B3|Baseline|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
962689|NCT00920140|B2|Baseline|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962690|NCT00920140|B1|Baseline|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962691|NCT00920140|P5|Participant Flow|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
962692|NCT00920140|P4|Participant Flow|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or chronic myelomonocytic leukemia (CMML) with RAS wild type (wt) or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
962693|NCT00920140|P3|Participant Flow|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory acute myeloid leukemia (AML) or myelodysplasia (MDS) with rat sarcoma (RAS) mutation received GSK1120212 2 mg OD as a continuous dose.
962694|NCT00920140|P2|Participant Flow|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962695|NCT00920140|P1|Participant Flow|GSK1120212 < 2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 milligrams (mg) loading dose (LD) followed by 1 mg once daily (OD) (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962696|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
962697|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
964579|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
962698|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
962699|NCT00920140|O1|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962700|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962701|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
962702|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
962703|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962704|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
962705|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
962706|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962707|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
962708|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
962709|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962710|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
962711|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
962712|NCT00920140|O3|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962713|NCT00920140|O2|Outcome|GSK1120212 1 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 1 mg OD as a continuous dose.
962714|NCT00920140|O1|Outcome|GSK1120212 0.5 mg OD/ 3/1 mg LD/OD|Participants with relapsed or refractory leukemias received either GSK1120212 0.5 mg OD or 3/1 mg LD/OD as a continuous dose.
962715|NCT00920140|O3|Outcome|Cohort 3: CMML With RAS Mutation|Participants with relapsed or refractory CMML with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
962716|NCT00920140|O2|Outcome|Cohort 2: AML/MDS/CMML With RAS wt/Unknown|Participants with relapsed or refractory AML or MDS or CMML with RAS wt or unknown mutation received GSK1120212 2 mg OD as a continuous dose.
962717|NCT00920140|O1|Outcome|Cohort 1: AML/MDS With RAS Mutation|Participants with relapsed or refractory AML or MDS with RAS mutation received GSK1120212 2 mg OD as a continuous dose.
962718|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962719|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962720|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962721|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962722|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962723|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962724|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962725|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962726|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
963042|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
962727|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962728|NCT00920140|O2|Outcome|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962729|NCT00920140|O1|Outcome|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962730|NCT00920140|E2|Reported Event|GSK1120212 2 mg OD|Participants with relapsed or refractory leukemias received GSK1120212 2 mg OD as a continuous dose.
962731|NCT00920140|E1|Reported Event|GSK1120212 <2 mg OD|Participants with relapsed or refractory leukemias received either GSK1120212 3 mg LD followed by 1 mg OD (3/1 mg LD/OD), or 1 mg OD as a continuous dose.
962732|NCT00920075|B1|Baseline|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
962733|NCT00920075|P1|Participant Flow|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
962785|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962734|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
962735|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
962736|NCT00920075|O1|Outcome|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
962737|NCT00920075|E1|Reported Event|1 Alendronate for 12 Months, Post Study|Participants earlier were treated with alendronate for 12 months either in an open label study (without control) or double blind study with placebo control. These studies were completed. In this post study evaluation, available participants will be scheduled for one clinic visit to assess their current status of the bone density and no treatment is involved.
962738|NCT00919932|B3|Baseline|Total|Total of all reporting groups
962739|NCT00919932|B2|Baseline|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
962740|NCT00919932|B1|Baseline|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
962741|NCT00919932|P2|Participant Flow|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
962742|NCT00919932|P1|Participant Flow|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
962743|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
962744|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
962769|NCT00919867|P2|Participant Flow|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
963043|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
962745|NCT00919932|O2|Outcome|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
962746|NCT00919932|O1|Outcome|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
962747|NCT00919932|E2|Reported Event|Text-message Homework|"Experimental treatment: therapy homework is completed by text messaging.~Text message system homework.: Homework will be standardized through the use of Judith Beck’s dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The novel text-messaging system allows homework to be submitted directly through an adolescent’s cellular phone, includes text-messaged homework reminder prompts, and collates all homework for therapists to review with patients during therapy sessions. This is assigned and reviewed weekly for 4 weeks."
962748|NCT00919932|E1|Reported Event|Paper and Pen Homework|"Treatment as usual: therapy homework is completed by paper and pen.~Paper and pen homework: Homework will be standardized through the use of Judith Beck's dysfunctional thought record (DTR), which is a primary tool for patients to evaluate and respond in writing to their automatic thoughts (Beck 126). The homework will be done on a preprinted form which is assigned weekly and reviewed with their therapists at weekly sessions for 4 weeks."
962749|NCT00919893|B3|Baseline|Total|Total of all reporting groups
962750|NCT00919893|B2|Baseline|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
962751|NCT00919893|B1|Baseline|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
962752|NCT00919893|P2|Participant Flow|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
962753|NCT00919893|P1|Participant Flow|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
962754|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
962755|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
962756|NCT00919893|O2|Outcome|Placebo|Oral placebo, 2 capsules every 8 hours, identical capsulation and weight only containing the inactive substances in proportional doses as compared with Cernilton for 12 weeks.
962757|NCT00919893|O1|Outcome|Cernilton|Oral Cernilton, 2 capsules every 8 hours with the active substance consisting of 60 mg Cernitin T60 (water-soluble fraction) and 3 mg Cernitin GBX (fat-soluble fraction)per capsule for 12 weeks.
962758|NCT00919867|B7|Baseline|Total|Total of all reporting groups
962759|NCT00919867|B6|Baseline|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
962760|NCT00919867|B5|Baseline|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
962761|NCT00919867|B4|Baseline|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
962762|NCT00919867|B3|Baseline|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
962763|NCT00919867|B2|Baseline|SPD503 First, Then SPD503 + Vyvanse, Then Vyvanse|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, Vyvanse single 50 mg dose in third intervention
962764|NCT00919867|B1|Baseline|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
962765|NCT00919867|P6|Participant Flow|SPD503 + Vyvanse, Then Vyvanse, Then SPD503|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
962766|NCT00919867|P5|Participant Flow|SPD503 + Vyvanse First, Then SPD503, Then Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Vyvanse single 50 mg dose in third intervention
962767|NCT00919867|P4|Participant Flow|Vyvanse First, Then SPD503 + Vyvanse, Then SPD503|Vyvanse single 50 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
962768|NCT00919867|P3|Participant Flow|Vyvanse First, Then SPD503, Then SPD503 + Vyvanse|Vyvanse single 50 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
962837|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
962770|NCT00919867|P1|Participant Flow|SPD503 First, Then Vyvanse, Then SPD503 + Vyvanse|SPD503 single 4 mg dose in first intervention, washout, Vyvanse single 50 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered in third intervention
962771|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962772|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
962773|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962774|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
962775|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962776|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
962777|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962778|NCT00919867|O1|Outcome|Vyvanse Alone|Single 50 mg dose
962779|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962780|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
962781|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962782|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
962783|NCT00919867|O2|Outcome|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962786|NCT00919867|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
962787|NCT00919867|E3|Reported Event|SPD503 + Vyvanse|SPD503 (single 4 mg dose) + Vyvanse (single 50 mg dose) coadministered
962788|NCT00919867|E2|Reported Event|Vyvanse Alone|Single 50 mg dose
962789|NCT00919867|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
962790|NCT00919854|B1|Baseline|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962791|NCT00919854|P1|Participant Flow|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962792|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962793|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962794|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962795|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962796|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962797|NCT00919854|O1|Outcome|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962798|NCT00919854|E1|Reported Event|DRV/Rtv|Before dose adjustment, oral darunavir suspension (100 mg/mL): 20 mg per kg body weight twice daily for children weighing between 10 and <20 kg. After dose adjustment, 25 mg per kg body weight twice daily if weight less than 15 kg, and fixed dose of 375 mg twice daily if weight more than or equal to 15 kg. Before dose adjustment, oral ritonavir solution (80 mg/mL): 3 mg per kg body weight twice daily and after dose adjustment fixed dose of 50 mg twice daily if weight more than or equal to 15 kg
962838|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
962839|NCT00919711|E2|Reported Event|Denosumab 60 mg Q6M|
962799|NCT00919802|B1|Baseline|All Study Participants|Patients will be randomized to receive a single dose of oxytocin 40 IU (20 IU to each nostril) or saline. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described.
962800|NCT00919802|P2|Participant Flow|Intranasal Saline Followed With Intranasal Oxytocin|"Saline, 4ml intranasally, once~Patients will be randomized to receive saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects.~Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time they will receive the alternative intranasal agent, Oxytocin a single dose of oxytocin 40 IU (20 IU to each nostril). Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
962801|NCT00919802|P1|Participant Flow|Intranasal Oxytocin, Followed by Intranasal Saline|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. Patients will be monitored for one hour by a physician investigator for toxicities and efficacy, and then contacted for follow-up information at 2, 4, 6 and 24 hours. The patient will be asked to return within a one-week period at which time the patient will receive the alternative intranasal agent. Following the second dose, the patient will be monitored for one hour and contact made at 2, 4, 6, and 24 hours as previously described."
963479|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
962802|NCT00919802|O2|Outcome|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
962803|NCT00919802|O1|Outcome|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
962804|NCT00919802|O2|Outcome|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
962805|NCT00919802|O1|Outcome|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
962806|NCT00919802|E2|Reported Event|Saline as a Nasal Spray|"Saline, 4ml intranasally, once~Saline as a nasal spray: A single dose of saline will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of oxytocin 40 IU as an alternate agent on the second day if needed."
962807|NCT00919802|E1|Reported Event|Oxytocin|"Oxytocin, 40 IU intranasally, once~Oxytocin: A single dose of oxytocin 40 IU (20 IU to each nostril) will be dispensed in a random fashion to subjects. A log will be kept so that the subject will receive a single does of saline as an alternate agent on the second day if needed."
962808|NCT00919763|B3|Baseline|Total|Total of all reporting groups
962809|NCT00919763|B2|Baseline|CD 2027 Vehicle, Twice Daily|Topical Ointment
962810|NCT00919763|B1|Baseline|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
962811|NCT00919763|P2|Participant Flow|CD 2027 Vehicle, Twice Daily|Topical Ointment
962812|NCT00919763|P1|Participant Flow|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
962813|NCT00919763|O2|Outcome|CD 2027 Vehicle, Twice Daily|Topical Ointment
962814|NCT00919763|O1|Outcome|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
962815|NCT00919763|E2|Reported Event|CD 2027 Vehicle, Twice Daily|Topical Ointment
962816|NCT00919763|E1|Reported Event|CD2027 Ointment 3 Mcg/g, Twice Daily|Topical Ointment
962817|NCT00919724|B3|Baseline|Total|Total of all reporting groups
962818|NCT00919724|B2|Baseline|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
962819|NCT00919724|B1|Baseline|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
962820|NCT00919724|P2|Participant Flow|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
962821|NCT00919724|P1|Participant Flow|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
962822|NCT00919724|O2|Outcome|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
962823|NCT00919724|O1|Outcome|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
962824|NCT00919724|E2|Reported Event|HIV-Uninfected|HIV-uninfected participants matched in age, sex, smoking status, and height to the HIV-infected participants
962825|NCT00919724|E1|Reported Event|HIV-Infected|HIV-infected participants who are not currently receiving antiretroviral medications
962826|NCT00919711|B3|Baseline|Total|Total of all reporting groups
962827|NCT00919711|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
962828|NCT00919711|B1|Baseline|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
962829|NCT00919711|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
962830|NCT00919711|P1|Participant Flow|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
962831|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
962832|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
962833|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
962834|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
962835|NCT00919711|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg subcutaneous once every 6 months
962836|NCT00919711|O1|Outcome|Risedronate 150 mg QM|Risedronate 150 mg oral once monthly
962840|NCT00919711|E1|Reported Event|Risedronate 150 mg QM|
962841|NCT00916643|B1|Baseline|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
962842|NCT00916643|P1|Participant Flow|H.E.L.P. Secura|"All patients received the same Treatment Arm for this study. Treatments were conducted up to 3 times per week; treatment sessions typ. 2 hours in length.~H.E.L.P. is a device composed of multiple modules and associated disposables to selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient.~Flush system with normal saline;~Filter whole blood through 0.2 micron plasma filter for continuous plasma removal;~Mix plasma with equal volume of acetate buffer containing heparin;~Precipitate LDL as a complex with heparin;~Remove LDL-heparin precipitate by continuous circulation through a filter;~Remove heparin with use of a heparin adsorber;~Bicarbonate dialysis and ultrafiltration to produce LDL-free plasma without excess heparin;~Re-mix LDL-free plasma with blood from plasma filter; return reconstituted blood to patient."
962843|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
962844|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
962845|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
962846|NCT00916643|O1|Outcome|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
962847|NCT00916643|E1|Reported Event|H.E.L.P. Secura|"The H.E.L.P. System is a device composed of multiple modules and their associated disposables which can selectively and continuously remove LDL-cholesterol from plasma by precipitating the LDL-cholesterol with high concentrations of heparin in an acidic buffer and returning the plasma to the patient. Procedure steps:~Flushing the system with normal saline.~Filtering whole blood through a 0.2 micron plasma filter for continuous plasma removal.~Mixing the plasma with an equal volume of acetate buffer containing heparin.~Precipitation of LDL as a complex with heparin.~Removing the LDL-heparin precipitate by continuous circulation through a filter.~Removing heparin with use of a heparin adsorber.~Bicarbonate dialysis and ultrafiltration to produce an LDL-free plasma without excess heparin.~Re-mixing the LDL-free plasma with blood coming from the plasma filter and returning the reconstituted blood to the patient."
962848|NCT00916617|B5|Baseline|Total|Total of all reporting groups
962849|NCT00916617|B4|Baseline|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962850|NCT00916617|B3|Baseline|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
962851|NCT00916617|B2|Baseline|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962852|NCT00916617|B1|Baseline|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
962853|NCT00916617|P4|Participant Flow|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962854|NCT00916617|P3|Participant Flow|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
962855|NCT00916617|P2|Participant Flow|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962856|NCT00916617|P1|Participant Flow|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
962857|NCT00916617|O4|Outcome|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962858|NCT00916617|O3|Outcome|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
962859|NCT00916617|O2|Outcome|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962860|NCT00916617|O1|Outcome|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
962861|NCT00916617|O4|Outcome|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
963055|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
962862|NCT00916617|O3|Outcome|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
962863|NCT00916617|O2|Outcome|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962864|NCT00916617|O1|Outcome|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
962865|NCT00916617|E4|Reported Event|Placebo + Bapineuzumab 10 mg|Participants who received placebo in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962866|NCT00916617|E3|Reported Event|Placebo + Bapineuzumab 5mg|Participants who received placebo in the parent study, Study NCT00663026, received 5 mg bapineuzumab in the current study.
962867|NCT00916617|E2|Reported Event|Bapineuzumab (10 mg + 10 mg)|Participants who received 10 mg in the parent study, Study NCT00663026, received 10 mg bapineuzumab in the current study.
962868|NCT00916617|E1|Reported Event|Bapineuzumab (5 mg + 5 mg)|Participants who received 5 milligram (mg) in the parent study, in Study NCT00663026, continued to receive 5 mg bapineuzumab in the current study.
962869|NCT00916539|B3|Baseline|Total|Total of all reporting groups
962870|NCT00916539|B2|Baseline|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962871|NCT00916539|B1|Baseline|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962872|NCT00916539|P2|Participant Flow|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962873|NCT00916539|P1|Participant Flow|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962874|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962875|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962876|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962877|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962878|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962879|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962880|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962881|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962882|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962883|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962884|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962885|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962886|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962887|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962888|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962889|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962890|NCT00916539|O2|Outcome|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962891|NCT00916539|O1|Outcome|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962892|NCT00916539|E2|Reported Event|Cast That Does Not Immobilize the Thumb|Cast that does not immobilize the thumb
962893|NCT00916539|E1|Reported Event|Cast That Immobilizes the Thumb|Cast that immobilizes the thumb
962894|NCT00919633|B5|Baseline|Total|Total of all reporting groups
962895|NCT00919633|B4|Baseline|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962896|NCT00919633|B3|Baseline|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962897|NCT00919633|B2|Baseline|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962898|NCT00919633|B1|Baseline|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962899|NCT00919633|P4|Participant Flow|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962900|NCT00919633|P3|Participant Flow|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962901|NCT00919633|P2|Participant Flow|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962902|NCT00919633|P1|Participant Flow|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
963056|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
962903|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962904|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962905|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962906|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962907|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962908|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962909|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962910|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962911|NCT00919633|O4|Outcome|Group 3: Interferon Alfa-2b (Dose 3)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962912|NCT00919633|O3|Outcome|Group 2: Interferon Alfa-2b (Dose 2)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962913|NCT00919633|O2|Outcome|Group 1: Interferon Alfa-2b (Dose 1)|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962914|NCT00919633|O1|Outcome|Group 4: Peginterferon Alfa-2b (1.5 μg/kg)|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962915|NCT00919633|E4|Reported Event|INTRON A 160,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962916|NCT00919633|E3|Reported Event|INTRON A 120,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962917|NCT00919633|E2|Reported Event|INTRON A 80,000|"continuous subcutaneous infusion for 48 weeks~external drug infusion pump : pump delivery system for continuous subcutaneous infusion of interferon alfa-2b~interferon alfa-2b : subcutaneous continuous infusion at one of three doses for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962918|NCT00919633|E1|Reported Event|PEGINTRON 1.5|"subcutaneous weekly for 48 weeks~peginterferon alfa-2b : 1.5 μg/kg subcutaneous weekly for 48 weeks~ribavirin, USP : All patients will receive oral ribavirin"
962919|NCT00919191|B1|Baseline|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
962920|NCT00919191|P1|Participant Flow|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
962921|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
962922|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split-face model
962923|NCT00919191|O2|Outcome|Adapalene Benzoyl Peroxide Facial Gel|Adapalene Benzoyl Peroxide Facial Gel used once daily on the alternate side of the face in a split-face model
962924|NCT00919191|O1|Outcome|Tretinoin Facial Gel|Tretinoin Facial Gel used once daily on one side of the face in a split face model
963008|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963057|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
964580|NCT00914186|O1|Outcome|Vehicle|once daily
962925|NCT00919191|E1|Reported Event|Tretinoin and Adapalene Benzoyl Peroxide Facial Gels|One group will use Retin-A MICRO Gel, (tretinoin) 0.04% Pump on the left side of the face and Epiduo Gel (adapalene .1% and benzoyl peroxide 2.5%), on the right side of the face daily for 3 consecutive weeks after washing with study-supplied facial wash. The other group will use the same products, but on opposite sides of the face for three consecutive weeks after washing with the same study-supplied facial wash.
962926|NCT00919126|B4|Baseline|Total|Total of all reporting groups
962927|NCT00919126|B3|Baseline|Group C|Medical Air in Oxygen (45%-55%)
962928|NCT00919126|B2|Baseline|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962929|NCT00919126|B1|Baseline|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962930|NCT00919126|P3|Participant Flow|Group C|Medical Air in Oxygen (45%-55%)
962931|NCT00919126|P2|Participant Flow|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962932|NCT00919126|P1|Participant Flow|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962933|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962934|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962935|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962936|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962937|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962938|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962939|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962940|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962941|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962942|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962943|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962944|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962945|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962946|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962947|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962948|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962949|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962950|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962951|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962952|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962953|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962954|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962955|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962956|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962957|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962958|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962959|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962960|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962961|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962962|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962963|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962964|NCT00919126|O2|Outcome|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962965|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962966|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962967|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
962968|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962969|NCT00919126|O3|Outcome|Group C|Medical Air in Oxygen (45%-55%)
962970|NCT00919126|O2|Outcome|Group B|Xenon 70%(65%-75%) in Oxygen (25%-35%)
962971|NCT00919126|O1|Outcome|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962972|NCT00919126|E3|Reported Event|Group C|Medical Air in Oxygen (45%-55%)
962973|NCT00919126|E2|Reported Event|Group B|Xenon 70% (65%-75%) in Oxygen (25%-35%)
962974|NCT00919126|E1|Reported Event|Group A|Xenon 50% (45%-55%) in Oxygen (45%-55%)
962975|NCT00919113|B3|Baseline|Total|Total of all reporting groups
962976|NCT00919113|B2|Baseline|Placebo|identical buffer
962977|NCT00919113|B1|Baseline|Uracyst|2% sodium chondroitin sulfate
962978|NCT00919113|P2|Participant Flow|Placebo|identical buffer
962979|NCT00919113|P1|Participant Flow|Uracyst|2% sodium chondroitin sulfate
962980|NCT00919113|O2|Outcome|Placebo|identical buffer
962981|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
962982|NCT00919113|O2|Outcome|Placebo|identical buffer
962983|NCT00919113|O1|Outcome|Uracyst|2% sodium chondroitin sulfate
962984|NCT00919113|E2|Reported Event|Placebo|"identical buffer~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
962985|NCT00919113|E1|Reported Event|Uracyst|"2% sodium chondroitin sulfate~One subject was misrandomized. Actual treatment was used for Demographic and Safety analysis."
962986|NCT00919061|B1|Baseline|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
963009|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963473|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
962987|NCT00919061|P1|Participant Flow|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
962988|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
962989|NCT00919061|O1|Outcome|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
962990|NCT00919061|E1|Reported Event|Gemcitabine and Cisplatin Plus Sorafenib|"This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.~Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:~Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.~Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle."
962991|NCT00919035|B1|Baseline|Torisel|"Single Agent Temsorilmus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
962992|NCT00919035|P1|Participant Flow|Torisel|"Single Agent Temsirolimus (Torisel®)~torisel: Patients will receive Torisel 25 mg weekly. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
962993|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
962994|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
962995|NCT00919035|O1|Outcome|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
962996|NCT00919035|E1|Reported Event|Torisel|"Single Agent Temsirolimus (Torisel®)~Patients will receive Torisel 25 mg weekly given as an intravenous infusion on days 1, 8, 15 and 33 every 28 days. Treatment continues until disease progression, patient's withdrawal, unacceptable toxicity or the investigator's discretion"
962997|NCT00918957|B3|Baseline|Total|Total of all reporting groups
962998|NCT00918957|B2|Baseline|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
962999|NCT00918957|B1|Baseline|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963000|NCT00918957|P2|Participant Flow|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963001|NCT00918957|P1|Participant Flow|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963002|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963003|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963004|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963005|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963006|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963007|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963054|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
963010|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963011|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963012|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963013|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963014|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963015|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963016|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963017|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963018|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963019|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963020|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963021|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963022|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963023|NCT00918957|O2|Outcome|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963024|NCT00918957|O1|Outcome|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963025|NCT00918957|E2|Reported Event|Placebo|Placebo 20 mg powder capsules. The dose regimen for the reference product was inhaling the contents of four capsules twice a day (bis in diem = b.i.d.) in the morning and in the evening for 28 days (on treatment), followed by 28 days of no study treatment (off treatment).
963026|NCT00918957|E1|Reported Event|TIP﻿ (Tobramycin Inhalation Powder)|Tobramycin 28 mg powder. The TIP dose of 112 mg twice a day (bis in diem = b.i.d.), given in a cycle of 28 days on treatment followed by 28 days off treatment.
963027|NCT00918931|B1|Baseline|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
963028|NCT00918931|P1|Participant Flow|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
963029|NCT00918931|O1|Outcome|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
963030|NCT00918931|E1|Reported Event|Obatoclax Mesylate|30 mg by vein over 3 hours Days 1-3, 14-day cycle
963031|NCT00918879|B3|Baseline|Total|Total of all reporting groups
963032|NCT00918879|B2|Baseline|Placebo|Placebo tablet, once daily( OD) for 24 weeks
963033|NCT00918879|B1|Baseline|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
963034|NCT00918879|P2|Participant Flow|Placebo|Placebo tablet, once daily( OD) for 24 weeks
963035|NCT00918879|P1|Participant Flow|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
963036|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
963037|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
963038|NCT00918879|O2|Outcome|Placebo|Placebo tablet, once daily( OD) for 24 weeks
963039|NCT00918879|O1|Outcome|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
963044|NCT00918879|E2|Reported Event|Placebo|Placebo tablet, once daily( OD) for 24 weeks
963045|NCT00918879|E1|Reported Event|Saxagliptin 5 mg|Saxagliptin 5 mg tablet, once daily( OD) for 24 weeks
963046|NCT00918866|B3|Baseline|Total|Total of all reporting groups
963047|NCT00918866|B2|Baseline|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
963048|NCT00918866|B1|Baseline|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
963049|NCT00918866|P2|Participant Flow|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
963050|NCT00918866|P1|Participant Flow|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
963051|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
963052|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
963053|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
963058|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
963059|NCT00918866|O2|Outcome|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
963060|NCT00918866|O1|Outcome|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
963061|NCT00918866|E2|Reported Event|Elevated Pulmonary Arterial Pressure|Subjects with a PAP of > or = to 35 mmHg.
963062|NCT00918866|E1|Reported Event|Low Pulmonary Arterial Pressure|Subjects with pulmonary arterial pressure (PAP) of < or = to 35 mmHg.
963063|NCT00918749|B4|Baseline|Total|Total of all reporting groups
963064|NCT00918749|B3|Baseline|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963065|NCT00918749|B2|Baseline|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963066|NCT00918749|B1|Baseline|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963067|NCT00918749|P3|Participant Flow|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963068|NCT00918749|P2|Participant Flow|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963069|NCT00918749|P1|Participant Flow|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963070|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963071|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963072|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963073|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963074|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963075|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963076|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963077|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963078|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963079|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963080|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963081|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963082|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963083|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963084|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963085|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963086|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963087|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963088|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963089|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963090|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963091|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963092|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963093|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963094|NCT00918749|O3|Outcome|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963095|NCT00918749|O2|Outcome|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963096|NCT00918749|O1|Outcome|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963097|NCT00918749|E3|Reported Event|100 mg|100 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963098|NCT00918749|E2|Reported Event|75 mg|75 mg risedronate tablet DRFB (delayed release following breakfast) administered orally immediately after ingesting breakfast
963099|NCT00918749|E1|Reported Event|150 mg|150 mg risedronate tablet IRBB (immediate release before breakfast) administered orally at least 30 minutes before breakfast.
963100|NCT00918736|B1|Baseline|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
963545|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963101|NCT00918736|P1|Participant Flow|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
963102|NCT00918736|O1|Outcome|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
963103|NCT00918736|E1|Reported Event|Hyaluronate Injection|All patients with unilateral ankle OA received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan) into the ankle joints.
963104|NCT00918684|B1|Baseline|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
963105|NCT00918684|P1|Participant Flow|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
963106|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
963107|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
963108|NCT00918684|O1|Outcome|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
963109|NCT00918684|E1|Reported Event|Escitalopram|"12-week open label with 2 week placebo period (14 weeks total)~Escitalopram: 10mg tab daily"
963110|NCT00918671|B1|Baseline|Medication-overuse Headache|Chronic daily headache combined with medication overuse
963111|NCT00918671|P1|Participant Flow|Medication-overuse Headache|Chronic daily headache combined with medication overuse
963112|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
963113|NCT00918671|O1|Outcome|Medication-overuse Headache|Chronic daily headache combined with medication overuse
963114|NCT00918671|E1|Reported Event|Medication-overuse Headache|Chronic daily headache combined with medication overuse
963115|NCT00918580|B1|Baseline|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963116|NCT00918580|P1|Participant Flow|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963117|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963118|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963119|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963120|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963121|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963122|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963123|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963124|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963125|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963126|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963163|NCT00918281|O3|Outcome|Relative Difference|The Relative difference between imaging sessions 1 and 2.
963127|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963128|NCT00918580|O1|Outcome|13vPnC|Participants previously immunized with 23-valent pneumococcal polysaccharide vaccine (23vPS) received 2 single 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection, 6 months apart.
963129|NCT00918580|E4|Reported Event|1-Year Follow-up|Participants previously immunized with 23vPS who received 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from the 6-month follow-up telephone contact after 13vPnC Dose 2 to the 1-year follow-up after 13vPnC Dose 2.
963130|NCT00918580|E3|Reported Event|6-Month Follow-up|Participants previously immunized with 23vPS who received at least 1 of the 2 single 0.5 mL doses of 13vPnC intramuscular injection, 6 months apart, assessed from last 13vPnC Dose (Dose 1 or Dose 2) blood draw to the 6-month follow-up telephone contact.
963131|NCT00918580|E2|Reported Event|13vPnC Dose 2|Participants previously immunized with 23vPS who received Dose 2 of 0.5 mL 13vPnC intramuscular injection, assessed between 13vPnC Dose 2 and before 13vPnC Dose 2 blood draw.
963132|NCT00918580|E1|Reported Event|13vPnC Dose 1|Participants previously immunized with 23vPS who received a single 0.5 mL dose of 13vPnC intramuscular injection on Day 1 (13vPnC Dose 1), assessed between 13vPnC Dose 1 and before 13vPnC Dose2.
963133|NCT00918385|B3|Baseline|Total|Total of all reporting groups
963134|NCT00918385|B2|Baseline|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
963135|NCT00918385|B1|Baseline|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
963136|NCT00918385|P2|Participant Flow|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
963137|NCT00918385|P1|Participant Flow|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
963138|NCT00918385|O1|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
963139|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
963140|NCT00918385|O2|Outcome|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
963141|NCT00918385|O1|Outcome|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
963142|NCT00918385|E3|Reported Event|Combination Nilutamide and Dasatinib|
963143|NCT00918385|E2|Reported Event|Arm 2= Low AR Dasatinib|"Low Androgen Receptor (AR) activity of < 0.50~Dasatinib: Dasatinib 100mg orally daily x 28 days per cycle. After first progression, Dasatinib 100mg orally each day in combination with Nilutamide 150mg orally each day for 28 days per cycle."
963144|NCT00918385|E1|Reported Event|Arm 1=High AR Nilutamide|"High Androgen Receptor (AR) activity of >= 0.50~Nilutamide: Nilutamide 150mg orally each day for 28 days per cycle. After first progression, Nilutamide 150mg orally each day in combination with Dasatinib 100mg orally each day for 28 days per cycle."
963145|NCT00918346|B1|Baseline|Entire Study Population|Includes all 43 randomized patients (86 eyes)
963146|NCT00918346|P2|Participant Flow|Unpreserved Formulation First, Then Preserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks, then preserved formulation (after washout)
963147|NCT00918346|P1|Participant Flow|Preserved Formulation First, Then Unpreserved Formulation|Tafluprost 0.0015% preserved formulation once daily for first 4 weeks, then unpreserved formulation (after washout)
963148|NCT00918346|O1|Outcome|RM ANCOVA: PP Efficacy Dataset|randomized patients who completed the study per protocol (PP)
963149|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized who received at least one dose of study medication and had at least one IOP measurement
963150|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
963151|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
963152|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
963153|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
963154|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
963155|NCT00918346|O1|Outcome|RM ANCOVA: ITT Efficacy Dataset|randomized and received study medication
963156|NCT00918346|O2|Outcome|Unpreserved Formulation|tafluprost 0.0015% unpreserved formulation
963157|NCT00918346|O1|Outcome|Preserved Formulation|tafluprost 0.0015% preserved formulation
963158|NCT00918346|E2|Reported Event|Unpreserved Formulation|Tafluprost 0.0015% unpreserved formulation once daily for first 4 weeks
963159|NCT00918346|E1|Reported Event|Preserved Formulation|Tafluprost 0.0015% preserved formulation once daily for 4 weeks
963160|NCT00918281|B1|Baseline|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
963161|NCT00918281|P1|Participant Flow|1 Fluciclatide Injection|AH111585 (18F) Injection : AH111585 (18F) Injection
963162|NCT00918281|O1|Outcome|Number of Adverse Events|The number of adverse events in relationship to the categories descrbed using Fluciclatide Injection (AH111585 (18F) Injection).
963164|NCT00918281|O2|Outcome|Imaging Session 2|Fluciclatide Injection (AH111585 (18F) Injection)
963165|NCT00918281|O1|Outcome|Imaging Session 1|Fluciclatide Injection (AH111585 (18F) Injection) at 10mCi [370 megabecquerels (MBq)]
963166|NCT00918281|E1|Reported Event|1 Fluciclatide Injection|Fluciclatide Injection (AH111585 (18F) Injection)
963167|NCT00918255|B4|Baseline|Total|Total of all reporting groups
963168|NCT00918255|B3|Baseline|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963169|NCT00918255|B2|Baseline|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963170|NCT00918255|B1|Baseline|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963171|NCT00918255|P3|Participant Flow|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963172|NCT00918255|P2|Participant Flow|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963173|NCT00918255|P1|Participant Flow|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963174|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963175|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963176|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963177|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963178|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963179|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963180|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963181|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963182|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963183|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963184|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963185|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963186|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963187|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963188|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963189|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963190|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963191|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963192|NCT00918255|O3|Outcome|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963193|NCT00918255|O2|Outcome|Adalimumab 40 mg Eow DB|Initial dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963194|NCT00918255|O1|Outcome|Adalimumab 40 mg Qwk DB|Initial dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963195|NCT00918255|E3|Reported Event|Placebo DB|Matching placebo for adalimumab, administered weekly starting at Week 0 through Week 15.
963196|NCT00918255|E2|Reported Event|Adalimumab 40 mg Eow DB|Loading dose of adalimumab 80 mg at Week 0, followed by adalimumab 40 mg eow (every other week) starting at Week 1 through Week 15.
963197|NCT00918255|E1|Reported Event|Adalimumab 40 mg Qwk DB|Loading dose of adalimumab 160 mg at Week 0, adalimumab 80 mg at Week 2, followed by 40 mg weekly (qwk) starting at Week 4 through Week 15.
963198|NCT00918203|B3|Baseline|Total|Total of all reporting groups
963199|NCT00918203|B2|Baseline|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963200|NCT00918203|B1|Baseline|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963201|NCT00918203|P3|Participant Flow|Crossover to Olaratumab Monotherapy|Olaratumab was administered IV at 15 mg/kg on Day 1 and Day 8 every 3 weeks.
963202|NCT00918203|P2|Participant Flow|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963203|NCT00918203|P1|Participant Flow|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel 200 milligram/square meter (mg/m2) over 3 hrs (Day 1) Carboplatin Area Under Concentration (AUC)=6 (Day 1) of each 21-day cycle~Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants who experience progressive disease may cross over to olaratumab monotherapy.~Paclitaxel: 200 mg/m2 is then administered intravenously (IV) over 3 hours~carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963204|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
964581|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
963205|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963206|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25 mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963207|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963208|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963209|NCT00918203|O2|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
963210|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963211|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963212|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963213|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963214|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
963215|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963216|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963217|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963248|NCT00918125|B3|Baseline|Total|Total of all reporting groups
963249|NCT00918125|B2|Baseline|White Patients|Patients who self-identified as White
963250|NCT00918125|B1|Baseline|Black Patients|Patients who self-identified as African American
963376|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963218|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963219|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
963220|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963221|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963222|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
963223|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963224|NCT00918203|O1|Outcome|Olaratumab + Pacilitaxel + Carboplatin|"Olaratumab: 15 mg/kg of olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963225|NCT00918203|O3|Outcome|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
963226|NCT00918203|O2|Outcome|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963227|NCT00918203|O1|Outcome|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab: 15 mg/kg of Olaratumab on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963228|NCT00918203|E3|Reported Event|Crossover to Olaratumab|Olaratumab monotherapy administered on Days 1 and 8 of each 21-day cycle.
963229|NCT00918203|E2|Reported Event|Paclitaxel + Carboplatin|"Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963230|NCT00918203|E1|Reported Event|Olaratumab + Paclitaxel + Carboplatin|"Olaratumab 15 mg/kg over 30 mins (Days 1 and 8) plus Paclitaxel 200 mg/m2 over 3 hrs (Day 1) Carboplatin AUC=6 (Day 1) of each 21-day cycle~Participants can remain on study after completing chemotherapy and receive olaratumab monotherapy on Days 1 and 8, provided there is ongoing evidence of clinical benefit.~Olaratumab: 15 mg/kg of IMC-3G3 on Days 1 and 8 of each 21-day cycle, administered IV at 25mg/min, with a minimum infusion time of 30 minutes.~Paclitaxel: 200 mg/m2 is then administered IV over 3 hours~Carboplatin: AUC=6 administered IV over 30 minutes on Day 1 of each 3-week cycle for a maximum of six cycles. Once the maximum of 6 cycles of carboplatin are reached the participant may continue on olaratumab maintenance for up to 12 months."
963231|NCT00918138|B3|Baseline|Total|Total of all reporting groups
963232|NCT00918138|B2|Baseline|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
963233|NCT00918138|B1|Baseline|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
963234|NCT00918138|P2|Participant Flow|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
963235|NCT00918138|P1|Participant Flow|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
963236|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
963237|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
963238|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
963239|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
963240|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
963241|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
963242|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
963243|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
963244|NCT00918138|O2|Outcome|Metformin 2000 mg|metformin XR 500 mg plus metformin XR 1500 mg plus matching saxagliptin 5 mg placebo
963245|NCT00918138|O1|Outcome|Saxagliptin 5 mg + Metformin XR 1500 mg|saxagliptin 5 mg plus metformin XR 1500 plus matching metformin XR 500 mg placebo
963246|NCT00918138|E2|Reported Event|Saxagliptin 5 mg + Metformin XR 1500 mg|Saxagliptin 5 mg plus Metformin XR 1500 plus matching Metformin XR 500 mg placebo
963247|NCT00918138|E1|Reported Event|Metformin 2000 mg|Metformin XR 500 mg plus Metformin XR 1500 mg plus matching Saxagliptin 5 mg placebo
963251|NCT00918125|P2|Participant Flow|Video Intervention|Patients in this arm viewed an educational video on sudden cardiac arrest and ICDs.
963252|NCT00918125|P1|Participant Flow|Standard of Care|Patients in this arm received standard of care (counseling from a physician).
963253|NCT00918125|O2|Outcome|Whites|All Whites in study
963254|NCT00918125|O1|Outcome|African Americans|All African Americans in study
963255|NCT00918125|O2|Outcome|Whites|Whites in study from all study arms
963256|NCT00918125|O1|Outcome|African Americans|African Americans in study from all study arms
963257|NCT00918125|O2|Outcome|Standard of Care|Usual care
963258|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
963259|NCT00918125|O2|Outcome|Standard of Care|Usual care
963260|NCT00918125|O1|Outcome|Video|All patients who saw an educational video
963261|NCT00918125|E1|Reported Event|All Patients|Patients in this arm received standard of care (counseling from a physician).
963262|NCT00917865|B1|Baseline|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
963263|NCT00917865|P1|Participant Flow|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
963264|NCT00917865|O4|Outcome|Mean SUV Maxat 40minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 40 minutes
963265|NCT00917865|O3|Outcome|Mean SUV Max at 28 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 28 minutes
963266|NCT00917865|O2|Outcome|Mean SUV Maxat 16 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 16 minutes
963267|NCT00917865|O1|Outcome|Mean SUV Max at 4 Minutes|The 79 malignant sextants were grouped according to their Gleason score. Low Gleason: 3+3 and 3+4 High Gleason: 4+3, 4+4, 5+5 The SUV max was then determined for each group at 4 minutes
963268|NCT00917865|O4|Outcome|Diagnostic Performance Per Sextant 40minutes Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~63 sextants were seen as true positive, 15 true negative, 25 false positive and 17 false negative"
963269|NCT00917865|O3|Outcome|Diagnostic Performance Per Sextant 28mins Post Injection|"At this time point, the 120 sextants analysed were categorized as followed:~65 sextants were seen as true positive, 20 true negative, 20 false positive and 15 false negative"
963270|NCT00917865|O2|Outcome|Diagnostic Performance Per sextant16mins Post Injetion|"At this time point, the 120 sextants analysed were categorized as followed:~68 sextants were seen as true positive, 14 true negative, 25 false positive and 13 false negative"
963271|NCT00917865|O1|Outcome|Diagnostic Performance Per Sextant at 4mins Post Injection|Each of the 120 sextants was visually analyzed for the presence or absence of tumor. 71 true positive, 7 True negative, 32 false positive and 8 false negative. Because of a technical error, 2 of the 120 sextants were not analysed at this time point.
963272|NCT00917865|E1|Reported Event|Radiotracer|[18F] FACBC 10mci injected intravenously prior to PET scan
963273|NCT00917852|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|
963274|NCT00917852|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|
963275|NCT00917852|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|
963276|NCT00917852|E1|Reported Event|CTAG Device Trauma Subjects|
963277|NCT00917735|B3|Baseline|Total|Total of all reporting groups
963278|NCT00917735|B2|Baseline|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year
963279|NCT00917735|B1|Baseline|Green Tea Extract|Green tea extract supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year
963280|NCT00917735|P2|Participant Flow|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
963281|NCT00917735|P1|Participant Flow|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of epigallocatechin gallate (EGCG).
963282|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
963283|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
963284|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
963285|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
963286|NCT00917735|O2|Outcome|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
963287|NCT00917735|O1|Outcome|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
963288|NCT00917735|E2|Reported Event|Sugar Pill|Placebo: Two placebo capsules twice daily after breakfast and dinner for one year. Placebo capsules contained maltodextrin, cellulose, and magnesium stearate.
963289|NCT00917735|E1|Reported Event|Green Tea Extract|Green tea extract (GTE) supplement: Two green tea extract capsules twice daily after breakfast and dinner for one year. GTE was a decaffeinated green tea extract, and each capsule contained a total of 328.8 ± 28.9 mg catechins including 210.7 ± 11.0 mg of EGCG.
963290|NCT00917644|B1|Baseline|Total Study Population|New 80 milligram (mg) atorvastatin tablets (test); marketed 80 mg atorvastatin commercial tablet (Lipitor®) (reference)
963291|NCT00917644|P2|Participant Flow|Reference Drug First|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period and new (test) 80 mg atorvastatin tablets as a single dose in the second intervention period (after washout period).
963292|NCT00917644|P1|Participant Flow|Test Drug First|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period and marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the second intervention period (after washout period).
963293|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
963294|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
963295|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
963296|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
963297|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
963611|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963298|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
963299|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
963300|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
963301|NCT00917644|O2|Outcome|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
963302|NCT00917644|O1|Outcome|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
963303|NCT00917644|E2|Reported Event|Reference Drug|Marketed (reference) 80 mg atorvastatin commercial tablet (Lipitor®) as a single dose in the first intervention period or second intervention period.
963304|NCT00917644|E1|Reported Event|Test Drug|New (test) 80 milligram (mg) atorvastatin tablets as a single dose in the first intervention period or second intervention period.
963305|NCT00917579|B1|Baseline|Total Number of Participants|All participants received atorvastatin 10 mg tablets (new and marketed).
963306|NCT00917579|P2|Participant Flow|Reference Drug First, Then Test Drug|Marketed (reference) 10 mg atorvastatin commercial tablet (Lipitor®) as a single oral dose in the first intervention period, and new (test) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
963307|NCT00917579|P1|Participant Flow|Test Drug First, Then Reference Drug|New (test) 10 milligram (mg) atorvastatin tablet as a single oral dose in the first intervention period, and marketed (reference) 10 mg atorvastatin tablet as a single oral dose in the second intervention period (after washout period).
963308|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
963309|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
963310|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
963311|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
963312|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
963313|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
963314|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
963315|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
963316|NCT00917579|O2|Outcome|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single oral dose in either first intervention period or second intervention period.
963317|NCT00917579|O1|Outcome|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose in either first intervention period or second intervention period.
963318|NCT00917579|E2|Reported Event|Reference Drug|Marketed (reference) 10 mg atorvastatin tablet (Lipitor®) as a single dose.
963319|NCT00917579|E1|Reported Event|Test Drug|New (test) 10 mg atorvastatin tablet as a single oral dose.
963320|NCT00917501|B3|Baseline|Total|Total of all reporting groups
963321|NCT00917501|B2|Baseline|Omega-3|Fish oil - 3 capsules/day
963322|NCT00917501|B1|Baseline|Placebo|Olive oil - 3 capsules/day
963323|NCT00917501|P2|Participant Flow|Omega-3|Fish oil - 3 capsules/day
963324|NCT00917501|P1|Participant Flow|Placebo|Olive oil - 3 capsules/day
963325|NCT00917501|O2|Outcome|Omega-3|Fish oil - 3 capsules/day
963326|NCT00917501|O1|Outcome|Placebo|Olive oil - 3 capsules/day
963327|NCT00917501|E2|Reported Event|Omega-3|Fish oil - 3 capsules/day
963328|NCT00917501|E1|Reported Event|Placebo|Olive oil - 3 capsules/day
963329|NCT00917384|B3|Baseline|Total|Total of all reporting groups
963330|NCT00917384|B2|Baseline|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963331|NCT00917384|B1|Baseline|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963332|NCT00917384|P2|Participant Flow|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus BSC as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963333|NCT00917384|P1|Participant Flow|IMC-1121B (Ramucirumab )|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined appropriate by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963474|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963475|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963334|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963335|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963336|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963337|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963338|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963339|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963340|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963341|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963342|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963343|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963344|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963345|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963375|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963346|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963347|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963348|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963349|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963350|NCT00917384|O2|Outcome|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963351|NCT00917384|O1|Outcome|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963352|NCT00917384|E2|Reported Event|Placebo|Participants received placebo by intravenous infusion every 2 weeks plus best supportive care as determined appropriate by the investigator(s). Because investigators and ancillary medical personnel were blinded as to assignment to active therapy versus placebo, the volume of placebo administered was calculated as if it were active product with a dose of 8 mg/kg. Treatment continued until there was evidence of PD, the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963353|NCT00917384|E1|Reported Event|IMC-1121B (Ramucirumab)|Participants received IMC-1121B (ramucirumab), administered via intravenous infusion every 2 weeks at a dose of 8 milligrams/kilogram (mg/kg), plus best supportive care (BSC) as determined by the investigator(s). Treatment continued until there was evidence of progressive disease (PD), the development of unacceptable toxicity, protocol noncompliance, or withdrawal of consent.
963354|NCT00917267|B3|Baseline|Total|Total of all reporting groups
963355|NCT00917267|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963356|NCT00917267|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963357|NCT00917267|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963358|NCT00917267|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963359|NCT00917267|O4|Outcome|Exenatide Twice Daily Without SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and without SU use at Screening
963360|NCT00917267|O3|Outcome|Exenatide Once Weekly Without SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and without SU use at Screening
963361|NCT00917267|O2|Outcome|Exenatide Twice Daily With SU Use at Screening|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks) and with SU use at Screening
963362|NCT00917267|O1|Outcome|Exenatide Once Weekly With SU Use at Screening|Subcutaneous injection of 2 mg exenatide, once a week and with SU use at Screening
963363|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963364|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963365|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963366|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963367|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963368|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963369|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963370|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963371|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963372|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963373|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963374|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963377|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963378|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963379|NCT00917267|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963380|NCT00917267|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963381|NCT00917267|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 22 weeks)
963382|NCT00917267|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
963383|NCT00917124|B3|Baseline|Total|Total of all reporting groups
963476|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963477|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963478|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963384|NCT00917124|B2|Baseline|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
963385|NCT00917124|B1|Baseline|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
963386|NCT00917124|P2|Participant Flow|INVOS|INVOS (In Vivo optical Spectroscopy): Monitoring cerebral oxygenation (rSO2) with INVOS device. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
963387|NCT00917124|P1|Participant Flow|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
963388|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
963389|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
963390|NCT00917124|O2|Outcome|INVOS|INVOS (In Vivo Optical Spectroscopy): Cerebral oxygenation (rSO2) monitoring with INVOS device. If rSO2 decreased for more than 20% from patient's baseline value, simple interventions were performed to prevent brain injury. These interventions included: repositioning of head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
963391|NCT00917124|O1|Outcome|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
963392|NCT00917124|E2|Reported Event|CONTROL|The CONTROL arm did not have INVOS or any other cerebral oxygenation monitoring, so interventions to control cerebral oxygenation were not performed.
963393|NCT00917124|E1|Reported Event|INVOS|INVOS : Monitoring cerebral oxygenation (rSO2) with INVOS. When rSO2 decline occur (decrease of rSO2 for more than 20% from patient's baseline value) it can be responded with simple interventions to prevent a brain injury. These interventions include: repositioning of the head or perfusion cannulae, increasing arterial carbon dioxide tension, increasing oxygen inspiration concentration, increasing arterial blood pressure, adjusting pump flow rate, temperature decreasing, increasing of anesthetic depth and blood transfusion.
963394|NCT00916929|B3|Baseline|Total|Total of all reporting groups
963395|NCT00916929|B2|Baseline|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
963396|NCT00916929|B1|Baseline|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
963397|NCT00916929|P2|Participant Flow|Cardiac Resynchronization Therapy (CRT-D) Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy device algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil.
963398|NCT00916929|P1|Participant Flow|Implantable Cardioverter Defibrillator (ICD) Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
963399|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
963400|NCT00916929|O1|Outcome|Cardiac Resynchronizaiton Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
963401|NCT00916929|O2|Outcome|Implantable Cardioverter Defibrillator (ICD) Device|Algorithm in cardiac device that measures intra-thoracic impedance from implanted leads
963402|NCT00916929|O1|Outcome|Cardiac Resynchronization Therapy (CRT-D) Device|Algorithm in cardiac device that measures intra-thoracic impedance from the implanted leads
963403|NCT00916929|E2|Reported Event|ICD Device|Impedance Monitoring Feature: Implantable Cardioverter Defibrillator (ICD) algorithm measures impedance from 2 vectors: right ventricle to can and right ventricle to coil
963404|NCT00916929|E1|Reported Event|CRT-D Device|Impedance Monitoring Feature: Cardiac Resynchronization Therapy (CRT-D) algorithm measures impedance from 2 vectors: left ventricle to can and right ventricle to coil
963405|NCT00916721|B3|Baseline|Total|Total of all reporting groups
963406|NCT00916721|B2|Baseline|Placebo|
963407|NCT00916721|B1|Baseline|Propranolol|
963463|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963408|NCT00916721|P2|Participant Flow|Placebo|A single oral dose of identical placebo capsule in a double-blind fashion
963409|NCT00916721|P1|Participant Flow|Propranolol|A single oral dose of propranolol or identical placebo capsule in a double-blind fashion. Propranolol dose was 0.67 mg/kg of the short-acting formulation, rounded to the nearest 10 mg, with a minimum dose of 40 mg and a maximum dose of 80 mg
963410|NCT00916721|O2|Outcome|Placebo|
963411|NCT00916721|O1|Outcome|Propranolol|
963412|NCT00916721|O2|Outcome|Placebo|
963413|NCT00916721|O1|Outcome|Propranolol|
963414|NCT00916721|O2|Outcome|Placebo|
963415|NCT00916721|O1|Outcome|Propranolol|
963416|NCT00916721|O2|Outcome|Placebo|
963417|NCT00916721|O1|Outcome|Propranolol|
963418|NCT00916721|E2|Reported Event|Placebo|
963419|NCT00916721|E1|Reported Event|Propranolol|
963420|NCT00916383|B1|Baseline|All Participants|All patients received the same study treatment, consisting of 1 placebo patch and 1 Donepezil Transdermal Patch, and all patches were applied to the same body locations according to 1 of 6 treatment sequences. The active patch was applied to either the right or the left side of the body according to the randomization schedule. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 body locations (upper arm, upper back, side of torso) for a total treatment period of 21 days.
963421|NCT00916383|P1|Participant Flow|All Participants|"Patients were randomized to receive the active patch on the left or right side of the body, and the matching placebo patch on the same location on the opposite side of the body, and assigned to one of two sets (left and right of the body for placement of the active patch) of the following 6 treatment sequences. The treatment sequence was repeated for the opposite side of the body for a total of 12 treatment sequences. The 7-day patches were applied to one of 3 consecutive body locations, for a total exposure period of 21 days.~Upper Back, Upper Arm, Side of Torso~Upper Arm, Side of Torso, Upper Back~Side of Torso, Upper Back, Upper Arm~Upper Back, Side of Torso, Upper Arm~Upper Arm, Upper Back, Side of Torso~Side of Torso, Upper Arm, Upper Back~Skin irritation scoring was obtained immediately upon removal of the patch and at 1, 24, and 48 hours after removal."
963422|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
963423|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
963424|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
963425|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
963426|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
963427|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
963428|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
963429|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
963430|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
963431|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
963432|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
963433|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
963434|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
963435|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
963436|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
963437|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
963438|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
963439|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
963440|NCT00916383|O3|Outcome|Side of Torso|DTP-system and placebo patch applied to opposite sides of torso.
963441|NCT00916383|O2|Outcome|Upper Arm|DTP-system and placebo patch applied to the upper part of opposite arms.
963442|NCT00916383|O1|Outcome|Upper Back|DTP-system and placebo patch applied to opposite sides of the upper back.
963443|NCT00916383|E3|Reported Event|Placebo Patch|Localized events
963444|NCT00916383|E2|Reported Event|DTP-system|Localized events
963445|NCT00916383|E1|Reported Event|Systemic Events|All enrolled patients
963446|NCT00916370|B3|Baseline|Total|Total of all reporting groups
963447|NCT00916370|B2|Baseline|Long Lesion Registry|Use of long lesion stents.
963448|NCT00916370|B1|Baseline|Core Size Registry|Core size indicates the range of diameters of the stents used.
963449|NCT00916370|P2|Participant Flow|Long Lesion Registry|Use of long lesion stents.
963450|NCT00916370|P1|Participant Flow|Core Size Registry|Core size indicates the range of diameters of the stents used.
963451|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963452|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963453|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963454|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963455|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963456|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963457|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963458|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963459|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963460|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963461|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963462|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963464|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963465|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963466|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963467|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963468|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963469|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963470|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963471|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963472|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963480|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963481|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963482|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963483|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963484|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963485|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963486|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963487|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963488|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963489|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963490|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963491|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963492|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963493|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963494|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963495|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963496|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963497|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963498|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963499|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963500|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963501|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963502|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963503|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963504|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963505|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963506|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963507|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963508|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963509|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963510|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963511|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963512|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963513|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963514|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963515|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963516|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963517|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963518|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963519|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963520|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963521|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963522|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963523|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963524|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963525|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963526|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963527|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963528|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963529|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963530|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963531|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963532|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963533|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963534|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963535|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963536|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963537|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963538|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963539|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963540|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963541|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963542|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963543|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963544|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963546|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963547|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963548|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963549|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963550|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963551|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963552|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963553|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963554|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963555|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963556|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963557|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963558|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963559|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963560|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963561|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963562|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963563|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963564|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963565|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963566|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963567|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963568|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963569|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963570|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963571|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963572|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963573|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963574|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963575|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963576|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963577|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963578|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963579|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963580|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963581|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963582|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963583|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963584|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963585|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963586|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963587|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963588|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963589|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963590|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963591|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963592|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963593|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963594|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963595|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963596|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963597|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963598|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963599|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963600|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963601|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963602|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963603|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963604|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963605|NCT00916370|O2|Outcome|Long Lesion Registry|use of long lesion stents.
963606|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963607|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963608|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963609|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963610|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963612|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963613|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963614|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963615|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963616|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963617|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963618|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963619|NCT00916370|O2|Outcome|Long Lesion Registry|Use of long lesion stents.
963620|NCT00916370|O1|Outcome|Core Size Registry|Core size indicates the range of diameters of the stents used.
963621|NCT00916370|E2|Reported Event|Long Lesion Registry|Use of long lesion stents.
963622|NCT00916370|E1|Reported Event|Core Size Registry|Core size indicates the range of diameters of the stents used.
963623|NCT00916357|B1|Baseline|Overall Study|Participants who received at least 1 dose of Humalog, Humalog + recombinant human hyaluronidase PH20 (rHuPH20), or Humulin-R + rHuPH20 during dose-finding (DV) visits or experimental (data gathering) visits.
963624|NCT00916357|P6|Participant Flow|Humulin-R + rHuPH20, Then Humalog + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog alone following a 3- to 14-day washout period.
963625|NCT00916357|P5|Participant Flow|Humulin-R + rHuPH20, Then Humalog, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3-to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
963626|NCT00916357|P4|Participant Flow|Humalog + rHuPH20, Then Humulin-R + rHuPH20, Then Humalog|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + rHuPH20. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog following a 3- to 14-day washout period.
963627|NCT00916357|P3|Participant Flow|Humalog + rHuPH20, Then Humalog, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humalog alone. The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period
963628|NCT00916357|P2|Participant Flow|Humalog, Then Humulin-R + rHuPH20, Then Humalog + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humalog + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
963660|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963805|NCT00915772|P2|Participant Flow|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963629|NCT00916357|P1|Participant Flow|Humalog, Then Humalog + rHuPH20, Then Humulin-R + rHuPH20|A subcutaneous (SC) injection of up to 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog. After a 3- to 14-day washout period, the DF process and injection of appropriate dose was repeated with up to 0.3- to 0.5-U/kg Humalog + 3.75 nanograms/kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20). The DF process and injection of appropriate dose was then repeated with 0.3- to 0.5-U/kg Humulin-R + 3.75 ng/kg rHuPH20 following a 3- to 14-day washout period.
963630|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963631|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963632|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963633|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963634|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963635|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963636|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963637|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963638|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963639|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963640|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963641|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963642|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963643|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963644|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963645|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963646|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963647|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963648|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963649|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963650|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963651|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963652|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963653|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963654|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963655|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963656|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963657|NCT00916357|O3|Outcome|Humulin-R + rHuPH20|Humulin-R + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humulin-R + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963658|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963659|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963802|NCT00915772|B2|Baseline|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963661|NCT00916357|O2|Outcome|Humalog + rHuPH20|Humalog + rHuPH20: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20)
963662|NCT00916357|O1|Outcome|Humalog Alone|Humalog alone: A single, subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) Humalog
963663|NCT00916357|E3|Reported Event|Humulin-R + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humulin-R + 3.75 nanograms per kilogram (ng/kg) of recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humulin-R + rHuPH20 during Periods 1, 2, or 3 of the Study
963664|NCT00916357|E2|Reported Event|Humalog + rHuPH20|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog + 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase PH20 (rHuPH20) for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout), followed by a single SC injection of the appropriate dose of Humalog + rHuPH20 during Periods 1, 2, or 3 of the study.
963665|NCT00916357|E1|Reported Event|Humalog Alone|Participants who received a subcutaneous (SC) injection of 0.3- to 0.5-units per kilogram (U/kg) of Humalog alone for up to 3 dose-finding (DF) visits (each visit separated by a 3- to 14-day washout period), followed by a SC injection of the appropriate dose of Humalog during Periods 1, 2, or 3 of the study.
963666|NCT00916344|B1|Baseline|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
963667|NCT00916344|P1|Participant Flow|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
963668|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
963669|NCT00916344|O1|Outcome|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
963670|NCT00916344|E1|Reported Event|Pacemaker Therapy|Evia DR-T/ DR / SR-T / SR Single (SR) and dual (DR) chamber pacemaker with telemetry function (T)
963671|NCT00916305|B3|Baseline|Total|Total of all reporting groups
963672|NCT00916305|B2|Baseline|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
963673|NCT00916305|B1|Baseline|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
963674|NCT00916305|P2|Participant Flow|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
963675|NCT00916305|P1|Participant Flow|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
963676|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
963677|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
963678|NCT00916305|O2|Outcome|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
963679|NCT00916305|O1|Outcome|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
963680|NCT00916305|E2|Reported Event|Unmodified Audio Video|"Participants will listen to the same music as the other arm, but only the track with unaltered music.~Unmodified audio video: An audio video with unaltered music"
963681|NCT00916305|E1|Reported Event|Modified Audio Video|"Participants will listen to an audio video modified to mimic noise induced hearing loss after one night at a loud club~Modified Audio video: An audio video modified to mimic noise induced hearing loss after one night at a loud club"
963682|NCT00916279|B1|Baseline|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
963683|NCT00916279|P1|Participant Flow|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
963684|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
963685|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
963686|NCT00916279|O1|Outcome|Lutonix PTCA Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
963687|NCT00916279|O1|Outcome|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
963688|NCT00916279|O1|Outcome|Lutonix DCB Catheter|Lutonix paclitaxel-coated PTCA balloon catheter
963689|NCT00916279|E1|Reported Event|Lutonix Catheter|Lutonix Paclitaxel-Coated Balloon: PTCA
963690|NCT00916136|B3|Baseline|Total|Total of all reporting groups
963691|NCT00916136|B2|Baseline|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
963692|NCT00916136|B1|Baseline|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
963693|NCT00916136|P2|Participant Flow|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
963694|NCT00916136|P1|Participant Flow|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
963695|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
963696|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
963697|NCT00916136|O2|Outcome|Skeletal Traction|A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.
963698|NCT00916136|O1|Outcome|Cutaneous Traction|Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.
963699|NCT00916136|E2|Reported Event|Skeletal Traction|"A small incision is made on the inside of the knee and a pin is surgically inserted through the bone. Weights are then attached that will pull traction on the broken femur. This traction pin will stay in until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
963728|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963700|NCT00916136|E1|Reported Event|Cutaneous Traction|"Applied by using a strap on boot that attaches to the leg. A rope is attached to the boot. Weight is attached to the rope to use gravity to pull traction. The traction is left in place until patient is taken to surgery for reduction of the femur fracture.~Femoral Traction: Temporary intervention to realign the broken bone and help relieve pressure and muscle spasms until operative fixation."
963701|NCT00916032|B1|Baseline|All Study Participants|Participants were randomized to receive via intravenous infusion 3000 International Units (IU) Advate using either one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) or the alternate sequence.
963702|NCT00916032|P2|Participant Flow|One 3000 IU Vial Then Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent followed by two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963703|NCT00916032|P1|Participant Flow|Two 1500 IU Vials Then One 3000 IU Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total) followed by one 3000 IU potency vial dissolved in 5 mL diluent.
963704|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963705|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963706|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963707|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963708|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963709|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963710|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963711|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963712|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963713|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963714|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963715|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963716|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963717|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963718|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963719|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963720|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963803|NCT00915772|B1|Baseline|M1000|Metformin 1000mg monotherapy twice daily
963721|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963722|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963723|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963724|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963725|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963726|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963727|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
964582|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
963729|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963730|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963731|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963732|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963733|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963734|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963735|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963736|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963737|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963738|NCT00916032|O2|Outcome|Two 1500 IU Vials|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using two 1500 IU potency vials dissolved in 5 mL diluent each (administered in 10 mL diluent in total)
963739|NCT00916032|O1|Outcome|One 3000 International Unit (IU) Vial|Participants received via intravenous (IV) infusion 3000 International Units (IU) Advate using one 3000 IU potency vial dissolved in 5 mL diluent
963740|NCT00916032|E2|Reported Event|Two 1500 IU Vials|
963741|NCT00916032|E1|Reported Event|One 3000 International Unit (IU) Vial|
963742|NCT00916006|B3|Baseline|Total|Total of all reporting groups
963743|NCT00916006|B2|Baseline|Vehicle|Vehicle gel once daily for 3 consecutive days
963744|NCT00916006|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963745|NCT00916006|P2|Participant Flow|Vehicle|Vehicle gel once daily for 3 consecutive days
963746|NCT00916006|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963747|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
963748|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963749|NCT00916006|O2|Outcome|Vehicle Gel|Vehicle Gel once daily for 3 consecutive days
963750|NCT00916006|O1|Outcome|PEP005 (Ingenol Mebutate) Gel|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963751|NCT00916006|E2|Reported Event|Vehicle|Vehicle gel once daily for 3 consecutive days
963752|NCT00916006|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963753|NCT00915902|B3|Baseline|Total|Total of all reporting groups
963754|NCT00915902|B2|Baseline|Placebo Followed by Treatment (Lovaza)|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by treatment (Lovaza) for 8 weeks
963755|NCT00915902|B1|Baseline|Treatment (Lovaza) Followed by Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks
963756|NCT00915902|P2|Participant Flow|Placebo Then Lovaza|Placebo for 8 weeks, then 4 week washout, then Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks
963757|NCT00915902|P1|Participant Flow|Lovaza Then Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks, then 4 week washout, then Placebo for 8 weeks
963758|NCT00915902|O2|Outcome|Placebo|Placebo: Placebo, two 1-gram capsules taken twice daily for 8 weeks
963759|NCT00915902|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Omega-3-acid ethyl esters: Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily
963804|NCT00915772|P3|Participant Flow|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963760|NCT00915902|E4|Reported Event|Placebo Followed by Treatment (Lovaza), During Treatment|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout.
963761|NCT00915902|E3|Reported Event|Placebo Followed by Treatment (Lovaza), During Placebo|Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout.
963762|NCT00915902|E2|Reported Event|Treatment (Lovaza) Followed by Placebo, During Placebo|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout.
963763|NCT00915902|E1|Reported Event|Treatment (Lovaza) Followed by Placebo, During Treatment|Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo.
963764|NCT00915876|B3|Baseline|Total|Total of all reporting groups
963765|NCT00915876|B2|Baseline|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
963766|NCT00915876|B1|Baseline|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
963767|NCT00915876|P2|Participant Flow|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
963768|NCT00915876|P1|Participant Flow|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
963769|NCT00915876|O2|Outcome|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
964583|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
963770|NCT00915876|O1|Outcome|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
963771|NCT00915876|E2|Reported Event|Paricalcitol|Paricalcitol: paricalcitol 1 mcg QD x 8 weeks
963772|NCT00915876|E1|Reported Event|Placebo|Placebo: Placebo for Paricalcitol 1 mcg QD x 8 weeks
963773|NCT00915798|B5|Baseline|Total|Total of all reporting groups
963774|NCT00915798|B4|Baseline|Control Nonsmokers|Control nonsmokers participated in the abstinence condition.
963775|NCT00915798|B3|Baseline|Control Smokers|Control smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
963776|NCT00915798|B2|Baseline|ADHD Nonsmokers|ADHD nonsmokers participated in the abstinence condition.
963777|NCT00915798|B1|Baseline|ADHD Smokers|ADHD smokers participated in two conditions: (1) after smoking a cigarette and (2) after overnight abstinence.
963778|NCT00915798|P4|Participant Flow|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
963779|NCT00915798|P3|Participant Flow|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
963780|NCT00915798|P2|Participant Flow|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
963781|NCT00915798|P1|Participant Flow|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
963782|NCT00915798|O4|Outcome|Control Nonsmokers|
963783|NCT00915798|O3|Outcome|Control Smokers|
963784|NCT00915798|O2|Outcome|ADHD Nonsmokers|
963785|NCT00915798|O1|Outcome|ADHD Smokers|
963786|NCT00915798|O4|Outcome|Control Nonsmokers|Control nonsmokers provided a blood sample.
963787|NCT00915798|O3|Outcome|Control Smokers|Control smokers provided a blood sample.
963788|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers with ADHD provided a blood sample.
963789|NCT00915798|O1|Outcome|Smokers With ADHD|Smokers with ADHD provided a blood sample.
963790|NCT00915798|O6|Outcome|Control Smokers After Smoking|Control smokers after smoking the first cigarette of the day
963791|NCT00915798|O5|Outcome|Smokers With ADHD After Smoking|Smokers with ADHD after smoking the first cigarette of the day
963792|NCT00915798|O4|Outcome|Control Nonsmokers|Nonsmokers participate in one condition.
963793|NCT00915798|O3|Outcome|Control Smokers After Abstinence|Control smokers after overnight abstinence (withdrawal).
963794|NCT00915798|O2|Outcome|Nonsmokers With ADHD|Nonsmokers participate in one condition.
963795|NCT00915798|O1|Outcome|Smokers With ADHD After Abstinence|Smokers with ADHD after overnight abstinence (withdrawal).
963796|NCT00915798|E4|Reported Event|Control Nonsmokers|Control nonsmokers participated in one fMRI scan during an experimental task consisting of mathematical problems.
963797|NCT00915798|E3|Reported Event|Control Smokers|"Control smokers participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each participant will undergo an fMRI scan during an experimental task consisting of mathematical problems and unpleasant and neutral pictures. Smokers will undergo two fMRI scans during similar experimental tasks under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
963798|NCT00915798|E2|Reported Event|Nonsmokers With ADHD|Nonsmokers with ADHD participated in one fMRI scan during an experimental task consisting of mathematical problems.
963799|NCT00915798|E1|Reported Event|Smokers With ADHD|"Smokers with ADHD participated in one overnight abstinence condition (withdrawal) and one smoking condition (smoking the first cigarette of the morning).~Cigarette smoking versus withdrawal in smokers: Each fMRI scan included an experimental task consisting of mathematical problems. Smokers participated in two fMRI scans during the experimental task under the following two conditions: (1) after smoking a cigarette and (2) after overnight abstinence (withdrawal)."
963800|NCT00915772|B4|Baseline|Total|Total of all reporting groups
963801|NCT00915772|B3|Baseline|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963806|NCT00915772|P1|Participant Flow|M1000|Metformin 1000mg monotherapy twice daily
963807|NCT00915772|O4|Outcome|Post-treat|7 days follow-up period
963808|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963809|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963810|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963811|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963812|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963813|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963814|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963815|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963816|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963817|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963818|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963819|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963820|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963821|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963822|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963823|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963824|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963825|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963826|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963827|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963828|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963829|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963830|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963831|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963832|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963833|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963834|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963835|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963836|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963837|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963838|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963839|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963840|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963841|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963842|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963843|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963844|NCT00915772|O3|Outcome|L2.5+M1000|Linagliptin 2.5mg and metformin 1000mg twice daily
963845|NCT00915772|O2|Outcome|L2.5+M500|Linagliptin 2.5mg and metformin 500mg twice daily
963846|NCT00915772|O1|Outcome|M1000|Metformin 1000mg monotherapy twice daily
963847|NCT00915772|E3|Reported Event|L2.5+M1000|Linagliptin 2.5 mg + Metformin 1000 mg twice daily
963848|NCT00915772|E2|Reported Event|L2.5+M500|Linagliptin 2.5 mg + Metformin 500 mg twice daily
963849|NCT00915772|E1|Reported Event|M1000|Metformin 1000 mg twice daily
963850|NCT00915759|B1|Baseline|ProKera and Bandage Contact Lens|Each participant received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
963851|NCT00915759|P1|Participant Flow|ProKera/Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
963852|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 3: bandage contact lens in place until postoperative day 1
963853|NCT00915759|O1|Outcome|ProKera|Group 3: ProKera in place until postoperative day 1
963854|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 2: bandage contact lens in place until postoperative day 3
963855|NCT00915759|O1|Outcome|ProKera|Group 2: ProKera in place until postoperative day 3
963856|NCT00915759|O2|Outcome|Bandage Contact Lens|Group 1: bandage contact lens in place until complete corneal re-repithelialization (healing)
963857|NCT00915759|O1|Outcome|ProKera|Group 1: ProKera in place until complete corneal re-repithelialization (healing)
963858|NCT00915759|E2|Reported Event|Bandage Contact Lens|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
963859|NCT00915759|E1|Reported Event|ProKera|Each patient received ProKera on dominant eye and bandage contact lens on fellow non-dominant eye after PRK
963860|NCT00915655|B1|Baseline|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
963861|NCT00915655|P1|Participant Flow|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
963862|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
963863|NCT00915655|O1|Outcome|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
963864|NCT00915655|E1|Reported Event|DRV/Rtv|Darunavir tablets 2 x 400 mg tablet once daily for 48 weeks. Ritonavir capsule 100 mg capsule once daily for 48 weeks.
963865|NCT00915603|B3|Baseline|Total|Total of all reporting groups
963866|NCT00915603|B2|Baseline|Paclitaxel/Carboplatin/Everolimus|
963867|NCT00915603|B1|Baseline|Paclitaxel/Carboplatin/Placebo|
963868|NCT00915603|P2|Participant Flow|Paclitaxel/Carboplatin/Everolimus|
963869|NCT00915603|P1|Participant Flow|Paclitaxel/Carboplatin/Placebo|
963870|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
963871|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
963872|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
963873|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
963874|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
963875|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
963876|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
963877|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
963878|NCT00915603|O2|Outcome|Paclitaxel/Bevacizumab/Placebo|Systemic Therapy
963879|NCT00915603|O1|Outcome|Paclitaxel/Bevacizumab/Everolimus|Systemic Therapy
963880|NCT00915603|E2|Reported Event|Paclitaxel/Bevacizumab/Placebo|
963881|NCT00915603|E1|Reported Event|Paclitaxel/Bevacizumab/Everolimus|
963882|NCT00915590|B3|Baseline|Total|Total of all reporting groups
963883|NCT00915590|B2|Baseline|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963914|NCT00915525|B2|Baseline|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963884|NCT00915590|B1|Baseline|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963885|NCT00915590|P2|Participant Flow|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963886|NCT00915590|P1|Participant Flow|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963887|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963888|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963889|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963890|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963891|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963892|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963893|NCT00915590|O2|Outcome|IL-1Ra First, Then Placebo|"10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963894|NCT00915590|O1|Outcome|Placebo First, Then IL-1Ra|"10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963895|NCT00915590|O2|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks~IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
963896|NCT00915590|O1|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~Placebo: Custom eye drop eye three times a day in both eyes for a period of 6 weeks~IL-1Ra: 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks"
963897|NCT00915590|O2|Outcome|IL-1RA First, Then Placebo|"It is our intent that 10 patients will complete a course of treatment with 5% custom made topical IL-1Ra, followed by a course of treatment with placebo~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963898|NCT00915590|O1|Outcome|Placebo First, Then IL-1RA|"It is our intent that 10 patients will complete a course of treatment with placebo, followed by a course of treatment with 5% custom made topical IL-1Ra.~IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks~Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks"
963899|NCT00915590|E3|Reported Event|Off Treatment|Off treatment
963900|NCT00915590|E2|Reported Event|IL-1Ra|IL-1Ra : 5% custom made topical IL-1Ra 3 times a day in both eyes for a period of 6 weeks
963901|NCT00915590|E1|Reported Event|Placebo|Placebo : Custom eye drop eye three times a day in both eyes for a period of 6 weeks
963902|NCT00915551|B3|Baseline|Total|Total of all reporting groups
963903|NCT00915551|B2|Baseline|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
963904|NCT00915551|B1|Baseline|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963905|NCT00915551|P2|Participant Flow|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
963906|NCT00915551|P1|Participant Flow|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963907|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
963908|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
963909|NCT00915551|O2|Outcome|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
963910|NCT00915551|O1|Outcome|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (Ingenol Mebutate) gel, 0.015% once daily for 3 consecutive days
963911|NCT00915551|E2|Reported Event|Vehicle Gel|Vehicle gel once daily for 3 consecutive days
963912|NCT00915551|E1|Reported Event|PEP005 (Ingenol Mebutate) Gel, 0.015%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 3 consecutive days
963913|NCT00915525|B3|Baseline|Total|Total of all reporting groups
963915|NCT00915525|B1|Baseline|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963916|NCT00915525|P2|Participant Flow|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963917|NCT00915525|P1|Participant Flow|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963918|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963919|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963920|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963921|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963922|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963923|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963924|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963925|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963926|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963927|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963928|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963929|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963930|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963931|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963932|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963933|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963934|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963935|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963936|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963937|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963938|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963939|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964132|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
963940|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963941|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963942|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963943|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963944|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963945|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963946|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963947|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964555|NCT00914186|B4|Baseline|TS-022 0.020%|lotion/once daily
963948|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963949|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963950|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963951|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963952|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963953|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963954|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963955|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963956|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963957|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963958|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963959|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963960|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963961|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963962|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963963|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963964|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963965|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963966|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963967|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963968|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963969|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963970|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963971|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963972|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963973|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964494|NCT00914810|E2|Reported Event|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
963974|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963975|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963976|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963977|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963978|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963979|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963980|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963981|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963982|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963983|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963984|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963985|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963986|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963987|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963988|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963989|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963990|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963991|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963992|NCT00915525|O2|Outcome|Botulinum Toxin Type A 150U|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963993|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963994|NCT00915525|O1|Outcome|Botulinum Toxin Type A 100U|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963995|NCT00915525|E22|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 13|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963996|NCT00915525|E21|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 12|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963997|NCT00915525|E20|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 11|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963998|NCT00915525|E19|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 10|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
963999|NCT00915525|E18|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 10|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964000|NCT00915525|E17|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 9|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964001|NCT00915525|E16|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 9|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964002|NCT00915525|E15|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 8|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964003|NCT00915525|E14|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 8|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964004|NCT00915525|E13|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 7|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964005|NCT00915525|E12|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 7|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964006|NCT00915525|E11|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 6|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964007|NCT00915525|E10|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 6|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964008|NCT00915525|E9|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 5|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964009|NCT00915525|E8|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 5|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964010|NCT00915525|E7|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 4|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964011|NCT00915525|E6|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 4|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964012|NCT00915525|E5|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 3|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964013|NCT00915525|E4|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 3|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964556|NCT00914186|B3|Baseline|TS-022 0.010%|lotion/once daily
964014|NCT00915525|E3|Reported Event|Botulinum Toxin Type A 150U Treatment Cycle 2|Botulinum toxin Type A 150U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964015|NCT00915525|E2|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 2|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964016|NCT00915525|E1|Reported Event|Botulinum Toxin Type A 100U Treatment Cycle 1|Botulinum toxin Type A 100U injected into the detrusor, after protocol specified criteria are met, and no more frequently than every 12 weeks.
964017|NCT00915499|B3|Baseline|Total|Total of all reporting groups
964018|NCT00915499|B2|Baseline|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
964019|NCT00915499|B1|Baseline|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
964020|NCT00915499|P2|Participant Flow|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
964021|NCT00915499|P1|Participant Flow|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
964022|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
964023|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
964024|NCT00915499|O2|Outcome|CPAP Mode|Positive airway pressure in the continuous positive airway pressure (CPAP) mode
964025|NCT00915499|O1|Outcome|ASV Mode|Positive airway pressure in the adaptive servo-ventilation (ASV) mode
964026|NCT00915499|E2|Reported Event|CPAP Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
964027|NCT00915499|E1|Reported Event|ASV Mode|VPAP Adapt SV : Comparison of ASV and CPAP modes for the treatment of complex sleep apnea
964028|NCT00915473|B3|Baseline|Total|Total of all reporting groups
964029|NCT00915473|B2|Baseline|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964030|NCT00915473|B1|Baseline|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964031|NCT00915473|P2|Participant Flow|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964032|NCT00915473|P1|Participant Flow|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964033|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964034|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964035|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964036|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964037|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964038|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964039|NCT00915473|O2|Outcome|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964040|NCT00915473|O1|Outcome|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the ipsilateral (unilateral headache) or bilateral (bilateral headache) occipital nerve.
964041|NCT00915473|E2|Reported Event|Placebo Injection|Subjects randomized to this arm will receive 2.75 mL normal saline plus 0.25 mL 1% lidocaine injected over the greater occipital nerve.
964133|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964042|NCT00915473|E1|Reported Event|Active Injection|Subjects randomized to this arm will receive 2.5 mL 0.5% bupivicaine plus 0.5 mL 20 mg methylprednisolone injected over the greater occipital nerve.
964043|NCT00915356|B6|Baseline|Total|Total of all reporting groups
964044|NCT00915356|B5|Baseline|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964045|NCT00915356|B4|Baseline|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964046|NCT00915356|B3|Baseline|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964047|NCT00915356|B2|Baseline|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964048|NCT00915356|B1|Baseline|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964557|NCT00914186|B2|Baseline|TS-022 0.005%|lotion/once daily
964049|NCT00915356|P5|Participant Flow|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964050|NCT00915356|P4|Participant Flow|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964051|NCT00915356|P3|Participant Flow|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964052|NCT00915356|P2|Participant Flow|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964053|NCT00915356|P1|Participant Flow|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964054|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964055|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964056|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964057|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964058|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964059|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964060|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964061|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964062|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964063|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964064|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964065|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964066|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964067|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964068|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964069|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964070|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964071|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964072|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964073|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964074|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964075|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964076|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964077|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964558|NCT00914186|B1|Baseline|Vehicle|once daily
964078|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964079|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964080|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964081|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964082|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964083|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964084|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964085|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964086|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964087|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964088|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964089|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964090|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964091|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964092|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964093|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964094|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964095|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964096|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964097|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964098|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964099|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964100|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964134|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964101|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964102|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964103|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964104|NCT00915356|O5|Outcome|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964105|NCT00915356|O4|Outcome|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964106|NCT00915356|O3|Outcome|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964107|NCT00915356|O2|Outcome|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964108|NCT00915356|O1|Outcome|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964109|NCT00915356|E5|Reported Event|Placebo|Sodium chloride, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h.
964110|NCT00915356|E4|Reported Event|AZD1305 Dose Group 4|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 180 mg/h.
964111|NCT00915356|E3|Reported Event|AZD1305 Dose Group 3|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 130 mg/h.
964112|NCT00915356|E2|Reported Event|AZD1305 Dose Group 2|AZD1305, iv single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 101 mg/h.
964113|NCT00915356|E1|Reported Event|AZD1305 Dose Group 1|AZD1305, intravenous (IV) single infusion given intravenously until successful conversion of Atrial Fibrillation to Sinus Rhythm occur or for a maximum of 30 minutes. Infusion rate 120 ml/h, dose rate 50 mg/h.
964114|NCT00915343|B1|Baseline|Entire Study|Included all participants randomized to receive hydrocortisone MR tablets orally OD first or hydrocortisone tablets orally TID first; in any of the intervention periods during the 12-week cross-over period of Part A or hydrocortisone MR tablets orally OD during the 6-month open-label period of Part B.
964115|NCT00915343|P3|Participant Flow|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD for 6 months.
964116|NCT00915343|P2|Participant Flow|Hydrocortisone TID Then Hydrocortisone MR OD - Part A|Participants received hydrocortisone tablets TID in the first intervention period then novel OD hydrocortisone MR tablets in the second intervention period, at the same total daily dose of 20 to 40 mg for 12 weeks.
964117|NCT00915343|P1|Participant Flow|Hydrocortisone MR OD Then Hydrocortisone TID - Part A|Participants received novel once daily (OD) hydrocortisone modified release (MR) tablets in the first intervention period then hydrocortisone tablets thrice daily (TID) in the second intervention period, at the same total daily dose of 20 to 40 milligram (mg) for 12 weeks.
964118|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964119|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964120|NCT00915343|O1|Outcome|Hydrocortisone OD Versus TID|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study. Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964121|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
964122|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964123|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964124|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
964125|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|During the 4-week run-in period prior to the first intervention period during Part A, participants on a twice-a-day (BID) regimen were transferred to a thrice-a-day (TID) regimen while maintaining the same total daily hydrocortisone dose. In the first and second intervention periods during Part A, participants were randomised to novel once daily (OD) treatment with hydrocortisone modified release (MR) tablets 20 to 40 milligram (mg) orally and the treatment continued for 12 weeks and returned every 4 weeks for study drug dispensation.
964126|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
964127|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964128|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964129|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
964130|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964131|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964183|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964135|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally OD during the entire 6-month period of Part B.
964136|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964137|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964138|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964139|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964140|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964141|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964142|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964143|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964559|NCT00914186|P4|Participant Flow|TS-022 0.020%|lotion/once daily
964144|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964145|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964146|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964147|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964148|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964149|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964150|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964151|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964152|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964153|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964154|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964155|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964156|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964157|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964158|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964159|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964160|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964161|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964162|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964163|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964164|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964165|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964166|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964167|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964168|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964169|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964170|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964171|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964172|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964173|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964174|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964175|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964176|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964177|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964178|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964179|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964180|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964181|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964182|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964184|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964185|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964186|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964187|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964188|NCT00915343|O2|Outcome|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally TID during Part A of the study.
964189|NCT00915343|O1|Outcome|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone MR tablets 20 to 40 mg orally OD during Part A of the study.
964190|NCT00915343|E5|Reported Event|Hydrocortisone MR Tablet OD - Part B (All 6 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the entire 6-month period of Part B.
964191|NCT00915343|E4|Reported Event|Hydrocortisone MR Tablet OD - Part B (Second 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the second 3 months of Part B (6 months).
964560|NCT00914186|P3|Participant Flow|TS-022 0.010%|lotion/once daily
964192|NCT00915343|E3|Reported Event|Hydrocortisone MR Tablet OD - Part B (First 3 Months)|Hydrocortisone MR tablets 20 to 40 mg orally, once daily (OD) during the first 3 months of Part B (6 months).
964193|NCT00915343|E2|Reported Event|Hydrocortisone Tablet TID - Part A|Hydrocortisone tablets 20 to 40 mg orally, thrice daily (TID) during the 12-week period of Part A.
964194|NCT00915343|E1|Reported Event|Hydrocortisone MR Tablet OD - Part A|Hydrocortisone modified release (MR) tablets 20 to 40 mg orally, once daily (OD) during the 12-week period of Part A.
964195|NCT00915278|B7|Baseline|Total|Total of all reporting groups
964196|NCT00915278|B6|Baseline|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964197|NCT00915278|B5|Baseline|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964198|NCT00915278|B4|Baseline|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964199|NCT00915278|B3|Baseline|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964200|NCT00915278|B2|Baseline|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964201|NCT00915278|B1|Baseline|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964202|NCT00915278|P6|Participant Flow|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964203|NCT00915278|P5|Participant Flow|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964204|NCT00915278|P4|Participant Flow|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964205|NCT00915278|P3|Participant Flow|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964206|NCT00915278|P2|Participant Flow|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964207|NCT00915278|P1|Participant Flow|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964208|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964209|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964210|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964211|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964212|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964213|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964214|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964215|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964216|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964561|NCT00914186|P2|Participant Flow|TS-022 0.005%|lotion/once daily
964217|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964218|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964219|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964220|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964221|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964222|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964223|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964224|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964225|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964226|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964227|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964228|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964229|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964230|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964231|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964232|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964233|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964234|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964235|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964236|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964237|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964238|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964239|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964562|NCT00914186|P1|Participant Flow|Vehicle|once daily
964240|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964241|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964242|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964243|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964244|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964245|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964246|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964247|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964248|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964249|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964250|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964251|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964252|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964253|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964254|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964255|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964256|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964257|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964258|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964259|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964260|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964261|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964262|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964563|NCT00914186|O2|Outcome|TS-022|lotion/once daily
964263|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964264|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964265|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964266|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964267|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964268|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964269|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964270|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964271|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964272|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964273|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964274|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964275|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964276|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964277|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964278|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964279|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964280|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964281|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964282|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964283|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964284|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964285|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964564|NCT00914186|O1|Outcome|Vehicle|once daily
964286|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964287|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964288|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964289|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964290|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964291|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964292|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964293|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964294|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964295|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964296|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964297|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964298|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964299|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964300|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964301|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964302|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964303|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964304|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964305|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964306|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964307|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964308|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964565|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
964309|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964310|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964311|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964312|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964313|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964314|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964315|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964316|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964317|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964318|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964319|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964320|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964321|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964322|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964323|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964324|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964325|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964326|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964327|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964328|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964329|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964330|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964331|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964566|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
964332|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964333|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964334|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964335|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964336|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964337|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964338|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964339|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964340|NCT00915278|O6|Outcome|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964341|NCT00915278|O5|Outcome|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964342|NCT00915278|O4|Outcome|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964343|NCT00915278|O3|Outcome|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964344|NCT00915278|O2|Outcome|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964345|NCT00915278|O1|Outcome|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964346|NCT00915278|E6|Reported Event|PF-04605412 136 mg|PF-04605412 136 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964347|NCT00915278|E5|Reported Event|PF-04605412 68 mg|PF-04605412 68 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964348|NCT00915278|E4|Reported Event|PF-04605412 34 mg|PF-04605412 34 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964349|NCT00915278|E3|Reported Event|PF-04605412 16.9 mg|PF-04605412 16.9 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964350|NCT00915278|E2|Reported Event|PF-04605412 11.25 mg|PF-04605412 11.25 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964351|NCT00915278|E1|Reported Event|PF-04605412 7.5 mg|PF-04605412 7.5 mg was administered intravenously as 2 hour infusion on Day 1 of each cycle. The first cycle lasted 4 weeks and the following cycles lasted 2 weeks each. Treatment was continued until intolerable toxicity, disease progression or participant withdrawal.
964352|NCT00915148|B1|Baseline|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
964353|NCT00915148|P1|Participant Flow|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
964354|NCT00915148|O1|Outcome|Women Delivered Within 6 Hours|"Nulliparous women, single pregnancy, > 37 weeks of pregnancy, fetus alive and cephalic presentation.~Ultrasound examinations: 2D transperineal scan"
964355|NCT00915148|O1|Outcome|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
964356|NCT00915148|E1|Reported Event|Women With Prolonged Labour|"Primi gravidae, single pregnancy, >37 weeks, fetus alive, cephalic presentation.~Ultrasound examination: Trans-abdominal and trans-perineal 3D ultrasound examination"
964357|NCT00914966|B1|Baseline|CINRYZE|"There were 3 potential dose escalation steps:~Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)~Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks~Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
964358|NCT00914966|P1|Participant Flow|CINRYZE|"There were 3 potential dose escalation steps:~Step 1: 1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks (starting dosing regimen for all subjects in the study)~Step 2: 2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks~Step 3: 2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks"
964359|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
964360|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
964361|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
964362|NCT00914966|O3|Outcome|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
964363|NCT00914966|O2|Outcome|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
964364|NCT00914966|O1|Outcome|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks.
964365|NCT00914966|E4|Reported Event|All Subjects|
964366|NCT00914966|E3|Reported Event|Step 3: 2500 Units|2500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
964367|NCT00914966|E2|Reported Event|Step 2: 2000 Units|2000 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
964368|NCT00914966|E1|Reported Event|Step 1: 1500 Units|1500 Units of CINRYZE (C1 inhibitor [human]) administered by IV infusion twice per week for 12 weeks
964369|NCT00914862|B6|Baseline|Total|Total of all reporting groups
964370|NCT00914862|B5|Baseline|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964371|NCT00914862|B4|Baseline|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964372|NCT00914862|B3|Baseline|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964373|NCT00914862|B2|Baseline|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964374|NCT00914862|B1|Baseline|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964375|NCT00914862|P5|Participant Flow|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964376|NCT00914862|P4|Participant Flow|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964377|NCT00914862|P3|Participant Flow|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964378|NCT00914862|P2|Participant Flow|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964379|NCT00914862|P1|Participant Flow|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with Attention Deficit Hyperactivity Disorder (ADHD) received a single 4 mg oral dose of ramelteon.
964380|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964381|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964382|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964383|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964384|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964385|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964386|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964387|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964388|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964389|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964390|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964391|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964392|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964393|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964394|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964395|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964396|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964397|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964398|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964399|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964400|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964401|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964402|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964403|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964404|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964405|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964406|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964407|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964408|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964409|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964410|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964411|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964412|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964413|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964414|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964415|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964416|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964417|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964418|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964419|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964420|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964421|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964422|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964423|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964424|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964425|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964426|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964427|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964428|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964429|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964430|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964431|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964432|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964433|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964434|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964435|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964436|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964437|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964438|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964439|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964440|NCT00914862|O5|Outcome|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964441|NCT00914862|O4|Outcome|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964442|NCT00914862|O3|Outcome|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964443|NCT00914862|O2|Outcome|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964444|NCT00914862|O1|Outcome|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964445|NCT00914862|E5|Reported Event|Healthy Adult Ramelteon 8 mg|Healthy adults (18 to 50 years old) received a single oral dose of 8 mg ramelteon.
964446|NCT00914862|E4|Reported Event|Adolescents Ramelteon 8 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 8 mg ramelteon.
964447|NCT00914862|E3|Reported Event|Adolescents Ramelteon 4 mg|Adolescents 12 to 17 years of age with insomnia received a single oral dose of 4 mg ramelteon.
964448|NCT00914862|E2|Reported Event|Children Ramelteon 8 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single oral 8 mg dose of ramelteon.
964449|NCT00914862|E1|Reported Event|Children Ramelteon 4 mg|Children 6 to 11 years of age who had insomnia associated with ADHD received a single 4 mg oral dose of ramelteon.
964450|NCT00914849|B3|Baseline|Total|Total of all reporting groups
964451|NCT00914849|B2|Baseline|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964452|NCT00914849|B1|Baseline|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964453|NCT00914849|P2|Participant Flow|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964454|NCT00914849|P1|Participant Flow|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg intravenous (IV)~Leukopheresis~Day 2 (if peripheral blood stem cell (PBSC) collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964455|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964456|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964457|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964458|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964459|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964460|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964461|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964462|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964463|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964493|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
964464|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964465|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964466|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964467|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964567|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
964468|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964469|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964470|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964471|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964472|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964473|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964474|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964475|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964476|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964477|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964478|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964479|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964480|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964481|NCT00914849|O2|Outcome|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964482|NCT00914849|O1|Outcome|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964483|NCT00914849|E2|Reported Event|Arm 2 - Recipient|"Standard of care and physician choice myeloablative or non-myeloablative chemotherapy with or without total body irradiation (permitted = cyclophosphamide and single dose total body irradiation (TBI) / fludarabine and busulfan / fractionated TBI and cyclophosphamide / fractionated TBI, etoposide, and cyclophosphamide / busulfan and cyclophosphamide / fludarabine, busulfan, and ATGAM~Day 0 = Stem Cell Transplant"
964484|NCT00914849|E1|Reported Event|Arm 1 - Donor|"Day 1~AMD3100 320 ug/kg IV~Leukopheresis~Day 2 (if PBSC collected is not sufficient)~AMD3100 320 ug/kg IV~Leukopheresis"
964485|NCT00914810|B3|Baseline|Total|Total of all reporting groups
964486|NCT00914810|B2|Baseline|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
964487|NCT00914810|B1|Baseline|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
964488|NCT00914810|P2|Participant Flow|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
964489|NCT00914810|P1|Participant Flow|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
964490|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
964491|NCT00914810|O1|Outcome|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
964492|NCT00914810|O2|Outcome|Vitamin D|Vitamin D (cholecalciferol) : 2000 I.U. daily for 6 weeks
964495|NCT00914810|E1|Reported Event|Placebo|Placebo : Placebo (sugar pill) daily for 6 weeks
964496|NCT00914589|B4|Baseline|Total|Total of all reporting groups
964497|NCT00914589|B3|Baseline|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964498|NCT00914589|B2|Baseline|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964499|NCT00914589|B1|Baseline|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964500|NCT00914589|P3|Participant Flow|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964501|NCT00914589|P2|Participant Flow|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964502|NCT00914589|P1|Participant Flow|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964503|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964504|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964505|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964506|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964507|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964508|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964509|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964510|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964511|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964512|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964513|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964514|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964515|NCT00914589|O3|Outcome|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964516|NCT00914589|O2|Outcome|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964517|NCT00914589|O1|Outcome|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964518|NCT00914589|E3|Reported Event|FXIII35IU/Kg|Recombinant factor XIII at a single dose of 35 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964519|NCT00914589|E2|Reported Event|FXIII17.5IU/Kg|Recombinant factor XIII at a single dose of 17.5 IU/kg lean body mass (LBM) was administered via slow i.v. push at a rate not exceeding two mL per minute.
964520|NCT00914589|E1|Reported Event|Placebo|Recombinant factor XIII placebo was administered as a single dose via slow i.v. push at a rate not exceeding two mL per minute.
964521|NCT00914485|B1|Baseline|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
964522|NCT00914485|P1|Participant Flow|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
964523|NCT00914485|O1|Outcome|Arm 1|"Provider clinical communication training intervention~Provider Communication Skills Training: Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
964524|NCT00914485|E1|Reported Event|Provider Communication Skills Training|"Consists of 4 separate 1-hour sessions, 1 per best act, in which physicians view 3 video-recorded performances of each act performed by trained actors of varied race/ethnicity."
964525|NCT00914459|B3|Baseline|Total|Total of all reporting groups
964526|NCT00914459|B2|Baseline|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964527|NCT00914459|B1|Baseline|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964528|NCT00914459|P2|Participant Flow|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964893|NCT00912964|B2|Baseline|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964529|NCT00914459|P1|Participant Flow|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 international units per kilogram [IU/kg] up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the Summary of Product Characteristics (SmPC).
964530|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964531|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964568|NCT00914186|O1|Outcome|Vehicle|once daily
964569|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
964570|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
964532|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964533|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964534|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964535|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964536|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964537|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964538|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964539|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964540|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964541|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964542|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964543|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964544|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964545|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964546|NCT00914459|O1|Outcome|ReFacto AF: All Participants|All participants (aged less than or equal to [<=] 12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964547|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964548|NCT00914459|O1|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964549|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964550|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964683|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
964551|NCT00914459|O2|Outcome|ReFacto AF: 6 to Less Than 12 Years|Participants of 6 to 12 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964552|NCT00914459|O1|Outcome|ReFacto AF: Less Than 6 Years|Participants below 6 years of age were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964553|NCT00914459|E1|Reported Event|ReFacto AF: All Participants|All participants (aged <=12 years of age) were treated with IV injections of ReFacto AF at a dose and frequency prescribed by the investigator (minimum dose of 17 IU/kg up to maximum dose of 51 IU/kg) as per local standard of care in accordance with the SmPC.
964554|NCT00914186|B5|Baseline|Total|Total of all reporting groups
964584|NCT00914186|O1|Outcome|Vehicle|once daily
964585|NCT00914186|O4|Outcome|TS-022 0.020%|lotion/once daily
964586|NCT00914186|O3|Outcome|TS-022 0.010%|lotion/once daily
964587|NCT00914186|O2|Outcome|TS-022 0.005%|lotion/once daily
964588|NCT00914186|O1|Outcome|Vehicle|once daily
964589|NCT00914186|E4|Reported Event|TS-022 0.020%|lotion/once daily
964590|NCT00914186|E3|Reported Event|TS-022 0.010%|lotion/once daily
964591|NCT00914186|E2|Reported Event|TS-022 0.005%|lotion/once daily
964592|NCT00914186|E1|Reported Event|Vehicle|once daily
964593|NCT00914069|B3|Baseline|Total|Total of all reporting groups
964594|NCT00914069|B2|Baseline|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964595|NCT00914069|B1|Baseline|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964596|NCT00914069|P2|Participant Flow|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964597|NCT00914069|P1|Participant Flow|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964598|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964599|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964600|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964601|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964602|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964603|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964604|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964605|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964606|NCT00914069|O2|Outcome|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964607|NCT00914069|O1|Outcome|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964608|NCT00914069|E2|Reported Event|Conventional Vascular Access|"Conventional vascular access~Conventional vascular access: Vascular access using conventional venous access device"
964609|NCT00914069|E1|Reported Event|RIVS Vascular Access|"RIVS vascular access~RIVS vascular access: Access to peripheral vasculature"
964625|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964894|NCT00912964|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964610|NCT00913913|B1|Baseline|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
964611|NCT00913913|P1|Participant Flow|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
964612|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
964613|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
964614|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
964633|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964615|NCT00913913|O1|Outcome|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
964616|NCT00913913|E1|Reported Event|Bevacizumab,IL-2, IFN, DC Vaccine|"Patients will be dosed with bevacizumab (10mg/kg) intravenously every two weeks beginning four weeks prior to the first vaccine. Each treatment week includes ultrasound guided intranodal DC-vaccine injection (1 X 107 cells/1mL), followed by 5 days of continuous intravenous infusion of IL-2 (18 MiU/m2), and three subcutaneous injections of IFNa-2b (6 MiU) (every other day)~DC vaccine: DC Vaccine therapy 10E7 intranodally every cycle~Bevacizumab: Bevacizumab 10mg/kg iv every 2 weeks~IL-2: IL-2 18 MiU/m2 CI 5 days~IFN: IFN 6 MiU subc TIW"
964617|NCT00913835|B3|Baseline|Total|Total of all reporting groups
964618|NCT00913835|B2|Baseline|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964619|NCT00913835|B1|Baseline|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964620|NCT00913835|P2|Participant Flow|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there is evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964621|NCT00913835|P1|Participant Flow|Olaratumab + Liposomal Doxorubicin|"20 milligrams per kilogram (mg/kg) of Olaratumab was administered as an intravenous (IV) infusion every 2 weeks (14 days) until there was evidence of progressive disease (PD) or development of unacceptable toxicity.~40 milligrams per square meter (mg/m²) of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964622|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964623|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964624|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Treatment|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964684|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
964626|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964627|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964628|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964629|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964630|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964631|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964632|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964634|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964635|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964636|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964637|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964638|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964639|NCT00913835|O1|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964640|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964641|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964642|NCT00913835|O3|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964895|NCT00912964|P3|Participant Flow|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964643|NCT00913835|O2|Outcome|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy.."
964644|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964645|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964646|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964647|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964648|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964649|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964650|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964702|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964651|NCT00913835|O2|Outcome|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964652|NCT00913835|O1|Outcome|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964653|NCT00913835|E3|Reported Event|Liposomal Doxorubicin: Optional Olaratumab Monotherapy|40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity followed by 20 mg/kg of Olaratumab administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.
964654|NCT00913835|E2|Reported Event|Liposomal Doxorubicin|"40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days). Treatment continued until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~Upon disease progression the participant had the option to receive Olaratumab monotherapy."
964655|NCT00913835|E1|Reported Event|Olaratumab and Liposomal Doxorubicin|"20 mg/kg of Olaratumab was administered as an IV infusion every 2 weeks (14 days) until there was evidence of PD or development of unacceptable toxicity up to 130 weeks.~40 mg/m² of liposomal doxorubicin was administered according to the manufacturer’s instructions every 4 weeks (28 days) until there was evidence of PD or development of unacceptable toxicity."
964656|NCT00913770|B4|Baseline|Total|Total of all reporting groups
964657|NCT00913770|B3|Baseline|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
964658|NCT00913770|B2|Baseline|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
964659|NCT00913770|B1|Baseline|Standard Care|Standard Care including receiving a referral.
964682|NCT00913692|P1|Participant Flow|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
964660|NCT00913770|P3|Participant Flow|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
964661|NCT00913770|P2|Participant Flow|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
964662|NCT00913770|P1|Participant Flow|Standard Care|Standard Care including receiving a referral.
964663|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
964664|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
964665|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
964703|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
964666|NCT00913770|O3|Outcome|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
964667|NCT00913770|O2|Outcome|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
964668|NCT00913770|O1|Outcome|Standard Care|Standard Care including receiving a referral.
964669|NCT00913770|E3|Reported Event|SBI+Bup|"Screening, Brief Intervention and Buprenorphine initiation~Brief Intervention with Buprenorphine initiation: Brief Negotiated Intervention is a manual-guided therapy designed for ED setting. Purpose- to assist patients recognize/change drug use and HIV risks. It combines techniques based on motivational interviewing and a stage-model of change. Goal- to decrease subject's ambivalence about accepting ED initiated buprenorphine treatment. Patients inducted onto buprenorphine in ED or home, based on level of withdrawal. ED induction goal- 8 mg first day. Home induction goal- 8 mg first day. Subjects receive supportive counseling and education by trained nurses in the PCC (seen within 24-72 hours of their ED visit). Following an initial 45-minute evaluation, the physician will administer Primary Care Management (PCM) weekly for 2 weeks, then every 2 weeks for 4 weeks and then monthly."
964670|NCT00913770|E2|Reported Event|SBIRT|"Screening, Brief Intervention and Facilitated Referral to Treatment~Brief Intervention: Brief Negotiated Intervention (BNI) is a manual-guided therapy that is designed to be feasible in the ED setting. The purpose of the BNI is to assist patients in recognizing and changing their drug use and HIV risk behaviors. It combines techniques based on motivational interviewing and a stage-model of change. The main goal of the interview is to decrease the subject's ambivalence about signing up for a formal drug treatment program."
964671|NCT00913770|E1|Reported Event|Standard Care|Standard Care including receiving a referral.
964672|NCT00913744|B3|Baseline|Total|Total of all reporting groups
964673|NCT00913744|B2|Baseline|Sham|Sham injection
964674|NCT00913744|B1|Baseline|Ocriplasmin|Intravitreal injection (125 µg)
964675|NCT00913744|P2|Participant Flow|Sham|Sham injection
964676|NCT00913744|P1|Participant Flow|Ocriplasmin|Intravitreal injection (125 µg)
964677|NCT00913744|O2|Outcome|Sham|Sham injection
964678|NCT00913744|O1|Outcome|Ocriplasmin|Intravitreal injection (125 µg)
964679|NCT00913744|E2|Reported Event|Sham|Sham injection
964680|NCT00913744|E1|Reported Event|Ocriplasmin|Intravitreal injection (125 µg)
964681|NCT00913692|B1|Baseline|Glutamine (Study Agent) or Glycine (Placebo)|Participants were enrolled and monitored to document presence of 2 clinically confirmed episodes of herpes labialis, 1 of which must be virologically confirmed, during the screening period. Participants took 15 gm of study agent or placebo by mouth twice daily for 5 months followed by a 2 week wash-out. Then participants took the other agent for another 5 months.
964685|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
964686|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the secondary outcomes could not be measured and analyzed.
964687|NCT00913692|O1|Outcome|Glutamine (Study Agent) or Glycine (Placebo)|One participant completed the study and one participant started the 1st treatment phase, but was withdrawn during the first treatment phase, hence the primary outcome could not be measured and analyzed.
964688|NCT00913692|E3|Reported Event|Treatment Phase 2|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
964689|NCT00913692|E2|Reported Event|Washout|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
964690|NCT00913692|E1|Reported Event|Treatment Phase 1|2 participants were eligible for the treatment phase of the study after the screening period. 1 participant completed treatment phase 1 & 2. 1 participant was withdrawn from treatment phase 1 after the investigator decided to place the study on hold.
964691|NCT00913523|B4|Baseline|Total|Total of all reporting groups
964692|NCT00913523|B3|Baseline|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964693|NCT00913523|B2|Baseline|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964694|NCT00913523|B1|Baseline|Tampon With GML|Regular and Super Tampon with GML added to the cover
964695|NCT00913523|P3|Participant Flow|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964696|NCT00913523|P2|Participant Flow|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964697|NCT00913523|P1|Participant Flow|Tampon With GML|Regular and Super Tampon with GML added to the cover
964698|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964699|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964700|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
964701|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964704|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964705|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964706|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
964707|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964708|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964709|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
964710|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964711|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964712|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
964713|NCT00913523|O3|Outcome|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964714|NCT00913523|O2|Outcome|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964715|NCT00913523|O1|Outcome|Tampon With GML|Regular and Super Tampon with GML added to the cover
964716|NCT00913523|E3|Reported Event|Tampon Normally Used|Type and Size of Tampon Normally Used by Subjects
964717|NCT00913523|E2|Reported Event|Tampon Without GML|Regular and Super Tampon without GML added to the cover
964718|NCT00913523|E1|Reported Event|Tampon With GML|Regular and Super Tampon with GML added to the cover
964719|NCT00913510|B3|Baseline|Total|Total of all reporting groups
964720|NCT00913510|B2|Baseline|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
964721|NCT00913510|B1|Baseline|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
964722|NCT00913510|P2|Participant Flow|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start.
964723|NCT00913510|P1|Participant Flow|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement, either started at screening visit or continued from before study start and start of CIC using LoFric Primo catheters.
964724|NCT00913510|O2|Outcome|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
964725|NCT00913510|O1|Outcome|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
964726|NCT00913510|E2|Reported Event|Anticholinergic Medication|Anticholinergic medication according to clinical practice and investigator´s judgement, i.e. Drug.
964727|NCT00913510|E1|Reported Event|CIC Using LoFric Primo|Anticholinergic medication according to clinical practice and investigator´s judgement and start of CIC using LoFric Primo catheters (3-6 times/24h), i.e. Drug + Device
964896|NCT00912964|P2|Participant Flow|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964897|NCT00912964|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964898|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964728|NCT00913458|B1|Baseline|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964729|NCT00913458|P7|Participant Flow|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
964730|NCT00913458|P6|Participant Flow|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
964731|NCT00913458|P5|Participant Flow|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
964732|NCT00913458|P4|Participant Flow|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964733|NCT00913458|P3|Participant Flow|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964734|NCT00913458|P2|Participant Flow|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964735|NCT00913458|P1|Participant Flow|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964736|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964737|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964738|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964899|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964739|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964740|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964741|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964750|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964742|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964743|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964744|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964745|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964746|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964900|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964901|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964747|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964748|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964749|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964751|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964752|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964753|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964754|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964806|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964755|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964756|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964757|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964774|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964758|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964759|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964760|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964761|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964762|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964902|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964903|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964904|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964763|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964764|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964765|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964766|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964767|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964768|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964769|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964770|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964905|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964906|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964771|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964772|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964773|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964775|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964776|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964777|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964778|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe.All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964807|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964779|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 = DAS28 = 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964780|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964781|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964798|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964782|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964783|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964784|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964785|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964786|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964808|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964787|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964788|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964789|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964790|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964791|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964792|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964793|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964794|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964861|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once. Patients in Part II (9 patients)have been injected twice with Liproca Depot. The second injection was after progression in Part I.
964795|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964796|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964797|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study
964825|NCT00913380|B3|Baseline|Total|Total of all reporting groups
964799|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964800|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964801|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964802|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964803|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964804|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964805|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964862|NCT00913263|E1|Reported Event|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
964863|NCT00913133|B1|Baseline|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
964809|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964810|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964811|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964812|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964813|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964814|NCT00913458|O1|Outcome|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964826|NCT00913380|B2|Baseline|Standard-dose CT|Aimed to 8 mSv in an average patient
964827|NCT00913380|B1|Baseline|Low-dose CT|Aimed to 2 mSv in an average patient
964828|NCT00913380|P2|Participant Flow|Standard-dose CT|Aimed to 8 mSv in an average patient
964815|NCT00913458|O3|Outcome|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964816|NCT00913458|O2|Outcome|MTX + PBO (Phase 2)|In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964817|NCT00913458|O1|Outcome|E25 + MTX (Phase 2)|In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study.
964818|NCT00913458|E7|Reported Event|Placebo (PBO) (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
964819|NCT00913458|E6|Reported Event|MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
964820|NCT00913458|E5|Reported Event|E25+MTX (Phase 3)|Phase 3 was a 26-week observational period in which Phase 2 responders progressively stopped treatment. It included a 2 to 4 week period of double blind MTX tapering (depending on the optimized MTX dose), followed by an observational period until Week 117.
964864|NCT00913133|P1|Participant Flow|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
964865|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
964866|NCT00913133|O1|Outcome|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
964867|NCT00913133|E1|Reported Event|Desirudin|desirudin 15 mg twice daily for a minimum of 5 days
964907|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964908|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964821|NCT00913458|E4|Reported Event|Placebo (PBO) (Phase 2)|"In Phase 2 Placebo (PBO) arm, the weekly dose of etanercept was tapered from the 50 mg dosage to a placebo injection. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept-matching placebo injection using a pre-filled syringe.~Methotrexate-matching placebo was administered once weekly as oral capsules. The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study. Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964822|NCT00913458|E3|Reported Event|MTX + PBO (Phase 2)|"In Phase 2 MTX + PBO arm, the weekly dose of etanercept was tapered from the 50 mg dosage. At Week 52, subjects assigned to this arm received a double blinded 25 mg dose of etanercept as a subcutaneous injection using a pre filled syringe. All weekly doses thereafter (ie, Weeks 53 to 90) were administered as an etanercept matching placebo injection using a pre-filled syringe.~Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study."
964823|NCT00913458|E2|Reported Event|E25 + MTX (Phase 2)|"In Phase 2 E25 + MTX arm, Etanercept 25 milligram (mg) was administered once weekly as a subcutaneous injection using the 25 mg pre filled syringe. Methotrexate was administered once weekly as oral capsules. All subjects received a dose of methotrexate during this Phase 2 study that was equal to their optimal methotrexate dose in earlier Phase 1 study.~The subjects received the study treatment for 39 weeks, unless the subject was evaluated as non-responder at Week 64 or Week 76 and discontinued the study.~Participants in sustained remission (Disease Activity Score based on 28-joints count [DAS28] <2.6) or with low disease activity (2.6 ≤ DAS28 ≤ 3.2) at Week 91 were classified as Phase 2 responder, and will continue to Phase 3 study"
964824|NCT00913458|E1|Reported Event|ETN 50 QW + MTX (Phase 1)|Phase 1 was a 52-week open-label, single-arm period in which all subjects were treated with etanercept (ETN) 50 mg once weekly plus methotrexate (MTX). MTX starting dose was 10 mg per week and could increase by 5 mg per week increments up to Week 8, and up to a maximum of 25 mg per week. Participants with Disease Activity Score based on 28-joints count [DAS28] ≤3.2 at Week 39 and DAS28 <2.6 at Week 52 classified as a phase 1 responder, and will continue to Phase 2 study.
964829|NCT00913380|P1|Participant Flow|Low-dose CT|Aimed to 2 mSv in an average patient
964830|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964831|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964832|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964833|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964834|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964835|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964836|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964837|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964838|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964839|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964840|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964841|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964842|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964843|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964844|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964845|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964846|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964847|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964848|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964849|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964850|NCT00913380|O2|Outcome|Standard-dose CT|Aimed to 8 mSv in an average patient
964851|NCT00913380|O1|Outcome|Low-dose CT|Aimed to 2 mSv in an average patient
964852|NCT00913380|E2|Reported Event|Standard-dose CT|Aimed to 8 mSv in an average patient
964853|NCT00913380|E1|Reported Event|Low-dose CT|Aimed to 2 mSv in an average patient
964854|NCT00913263|B1|Baseline|Group 1|Men with histologically confirmed localized prostate cancer (T1–T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
964855|NCT00913263|P1|Participant Flow|Hydroxyflutamide (2-HOF)|Men with histologically confirmed localized prostate cancer (T1-T2) predominantly in one side of the periferal zone, verified by biopsy. Age ≥ 45 years.
964856|NCT00913263|O1|Outcome|Part 1|Patients (24 patients) have been injected with Liproca depot once
964857|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
964858|NCT00913263|O1|Outcome|Part I|Patients () 24 patients) in Part I have been injected with Liproca Depot once.
964859|NCT00913263|O1|Outcome|Part I|Patients (24 patients) in Part I have been injected with Liproca Depot once.
964860|NCT00913263|O1|Outcome|Group 1|24 patients (Part I of the study) have been injected with Liproca Depot once.
964892|NCT00912964|B3|Baseline|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
965052|NCT00912808|E2|Reported Event|Sugar Pill|
964868|NCT00913081|B1|Baseline|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 1000 mg, Quercetin 2000 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
964869|NCT00913081|P1|Participant Flow|All Study Participants|Participants received one dose of Quercetin 500 mg, Quercetin 100 mg, Quercetin 200 mg, or placebo one hour before immediate-release niacin 500 mg and underwent flushing and pharmacodymic assessments for 8 hours after Quercetin dosing. Each participant then crossed over to one of the remaining dose group/placebo in a randomized, double blind fashion after a washout period of at least 7 days. Each participant received all three doses of Quercetin and placebo.
964870|NCT00913081|O4|Outcome|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964871|NCT00913081|O3|Outcome|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964872|NCT00913081|O2|Outcome|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964873|NCT00913081|O1|Outcome|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964874|NCT00913081|E4|Reported Event|Placebo|Participants received placebo one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964875|NCT00913081|E3|Reported Event|Quercetin 2000 mg|Participants received one dose of Quercetin 2000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964876|NCT00913081|E2|Reported Event|Quercetin 1000 mg|Participants received one dose of Quercetin 1000 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964877|NCT00913081|E1|Reported Event|Quercetin 500 mg|Participants received one dose of Quercetin 500 mg one hour before immediate-release niacin 500 mg and underwent flushing and laboratory assessment including plasma free fatty acid, beta-hydroxybutyrate and urinary eicosanoid metabolites for 8 hours after Quercetin dosing. Each participant then crossed over to the next dose group/placebo after a washout period of at least 7 days.
964878|NCT00913003|B3|Baseline|Total|Total of all reporting groups
964879|NCT00913003|B2|Baseline|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
964880|NCT00913003|B1|Baseline|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
964881|NCT00913003|P2|Participant Flow|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
964882|NCT00913003|P1|Participant Flow|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
964883|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
964884|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
964885|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
964886|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
964887|NCT00913003|O2|Outcome|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
964888|NCT00913003|O1|Outcome|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
964889|NCT00913003|E2|Reported Event|Lidocaine|"Group A lidocaine infusion and bolus.~Lidocaine: Lidocaine bolus infusion 1.5 mg/kg IV using participants IBW(Ideal Body Weight) Lidocaine infusion after bolus and continuing until 1 hour after skin closure 33.3 mcg/kg/mn IV (IBW)"
964890|NCT00913003|E1|Reported Event|Placebo|"Group B using saline as a placebo.~Placebo: Placebo (normal saline) bolus similar to the lidocaine infusion minus active drug"
964891|NCT00912964|B4|Baseline|Total|Total of all reporting groups
965053|NCT00912808|E1|Reported Event|Donepezil|
964909|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964910|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964911|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964912|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964913|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964914|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964915|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964916|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964917|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964918|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964919|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964920|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964921|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964922|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964923|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964924|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964925|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964926|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964927|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964928|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964929|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964930|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964931|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964932|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964933|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964934|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964935|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964936|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964937|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964938|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964939|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964940|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964941|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964942|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964943|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964944|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964945|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964946|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964947|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964948|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964949|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964950|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964951|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964952|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964953|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964954|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964955|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964956|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964957|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964958|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964959|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964960|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964961|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964962|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964963|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964964|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964965|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964966|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964967|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964968|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964969|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964970|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964971|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964972|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964973|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964974|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964975|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964976|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964977|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964978|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964979|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964980|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964981|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964982|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964983|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964984|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964985|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964986|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964987|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964988|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964989|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964990|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964991|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964992|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964993|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964994|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964995|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964996|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
964997|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
964998|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
964999|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
965000|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
965001|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
965002|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
965003|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
965004|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
965005|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
965006|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
965007|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
965008|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
965009|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
965010|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
965011|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
965012|NCT00912964|O3|Outcome|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
965013|NCT00912964|O2|Outcome|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
965014|NCT00912964|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
965015|NCT00912964|E3|Reported Event|Mirabegron 50 mg|Participants received mirabegron 50 mg tablets orally once a day for 12 weeks.
965016|NCT00912964|E2|Reported Event|Mirabegron 25 mg|Participants received mirabegron 25 mg tablets orally once a day for 12 weeks.
965017|NCT00912964|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once a day for 12 weeks.
965018|NCT00912925|B3|Baseline|Total|Total of all reporting groups
965019|NCT00912925|B2|Baseline|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965020|NCT00912925|B1|Baseline|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965021|NCT00912925|P2|Participant Flow|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965022|NCT00912925|P1|Participant Flow|Placebo|Patients in the placebo-control group were administered a solution of 100 millimolar (mM) sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965023|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965024|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965025|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965026|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965027|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965086|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
965087|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
965028|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965029|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965030|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965031|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965032|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965033|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965034|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965035|NCT00912925|O2|Outcome|Aldurazyme Treatment|Patients in the active treatment group received Aldurazyme intravenously at a dose of 100 Units/kg (approximately 0.58 mg/kg = labeled dose) administered intravenously over approximately 4 hours once weekly for 26 weeks.
965036|NCT00912925|O1|Outcome|Placebo|Patients in the placebo-control group were administered a solution of 100 mM sodium phosphate, 150 mM sodium chloride, and 0.001% polysorbate-80, adjusted to a pH of 5.8 administered intravenously over approximately 4 hours once weekly for 26 weeks.
965037|NCT00912925|E2|Reported Event|Aldurazyme***Check Title***|Aldurazyme***Check Description***
965038|NCT00912925|E1|Reported Event|Placebo***Check Title***|Placebo***Check Description***
965039|NCT00912912|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
965040|NCT00912912|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
965041|NCT00912912|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
965042|NCT00912912|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg capsules once a day (by mouth) for 4 weeks in a row in a 6 week cycle.
965043|NCT00912808|B3|Baseline|Total|Total of all reporting groups
965044|NCT00912808|B2|Baseline|Sugar Pill|
965045|NCT00912808|B1|Baseline|Donepezil|
965046|NCT00912808|P2|Participant Flow|Sugar Pill|
965047|NCT00912808|P1|Participant Flow|Donepezil|
965048|NCT00912808|O2|Outcome|Sugar Pill|
965049|NCT00912808|O1|Outcome|Donepezil|
965050|NCT00912808|O2|Outcome|Sugar Pill|
965051|NCT00912808|O1|Outcome|Donepezil|
965055|NCT00912795|B2|Baseline|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
965056|NCT00912795|B1|Baseline|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
965057|NCT00912795|P2|Participant Flow|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
965058|NCT00912795|P1|Participant Flow|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
965059|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
965088|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
965089|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
965090|NCT00912743|O1|Outcome|MSI-H|MSI-H group receiving olaparib 400mg BID
965091|NCT00912743|E2|Reported Event|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
965092|NCT00912743|E1|Reported Event|MSI-H|MSI-H group receiving olaparib 400mg BID
965060|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
965061|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
965062|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
965063|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
965064|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
965065|NCT00912795|O2|Outcome|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
965066|NCT00912795|O1|Outcome|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
965067|NCT00912795|E2|Reported Event|Brochure Control|"A 7-page brochure that provided general information and tips on how to quit smoking. Participants did not receive any text messages.~The brochure encouraged smokers to follow 5 steps to quitting : (1) set a quit day and sign a contract, (2) find out about their smoking patterns-why they smoke, (3) practice quitting and change their patterns, (4) involve their family and friends, and (5) learn to be a self-supporter."
965068|NCT00912795|E1|Reported Event|SMS Turkey|"6-week smoking cessation program delivered via daily text messages~SMS Turkey: 6-week smoking cessation program delivered via text messaging. SMS Turkey content is guided by the Cognitive Behavioral Therapy (CBT) theory.~Content was tailored based on participant's stage in quitting (i.e., pre-quit, quit day, early-quit, late-quit, relapse). Based on the typical relapse trajectory, content paths were created for participants based on whether or not they were smoking 2 days after quit day; and again at 7 days after quit day.~Depending on the participant’s content path, the total number of messages received ranged from 91 (for those assigned to the encouragement arm) to 146 (for those who relapsed and then were assigned to the late quit messages)."
965069|NCT00912782|B3|Baseline|Total|Total of all reporting groups
965070|NCT00912782|B2|Baseline|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
965071|NCT00912782|B1|Baseline|Placebo|Placebo one time per week for 3 weeks
965072|NCT00912782|P2|Participant Flow|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
965073|NCT00912782|P1|Participant Flow|Placebo|Placebo one time per week for 3 weeks
965074|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
965075|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
965076|NCT00912782|O2|Outcome|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
965077|NCT00912782|O1|Outcome|Placebo|Placebo one time per week for 3 weeks
965078|NCT00912782|E2|Reported Event|Cholecalciferol|Vitamin D 200,000 IU per week for 3 weeks
965079|NCT00912782|E1|Reported Event|Placebo|Placebo one time per week for 3 weeks
965080|NCT00912743|B3|Baseline|Total|Total of all reporting groups
965081|NCT00912743|B2|Baseline|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
965082|NCT00912743|B1|Baseline|MSI-H|MSI-H group receiving olaparib 400mg BID
965083|NCT00912743|P2|Participant Flow|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
965084|NCT00912743|P1|Participant Flow|MSI-H|MSI-H group receiving olaparib 400mg BID
965085|NCT00912743|O2|Outcome|Non-MSI-H|Non-MSI-H group receiving olaparib 400mg BID
965093|NCT00912509|B3|Baseline|Total|Total of all reporting groups
965094|NCT00912509|B2|Baseline|45 Minute Light Duration|"45 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965095|NCT00912509|B1|Baseline|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965096|NCT00912509|P2|Participant Flow|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965097|NCT00912509|P1|Participant Flow|30 Minute Light Duration|"30 minute treatment with UVX light~riboflavin: riboflavin 0.1% is applied every 2 minutes for 30 minutes~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965098|NCT00912509|O2|Outcome|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965099|NCT00912509|O1|Outcome|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965100|NCT00912509|E2|Reported Event|45 Minute Light Duration|"45 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965101|NCT00912509|E1|Reported Event|30 Minute Light Duration|"30 minute treatment with UVX light~UVX Light: UVX 365 nm wavelength light source is applied with continued application of riboflavin 0.1%"
965102|NCT00912405|B1|Baseline|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
965103|NCT00912405|P1|Participant Flow|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
965104|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
965105|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
965106|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
965107|NCT00912405|O1|Outcome|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
965108|NCT00912405|E1|Reported Event|Sinexus Intranasal Splint|"Patient receives a drug-coated intranasal splint~Steroid-Eluting Sinexus Intranasal Splint: Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)"
965109|NCT00912301|B4|Baseline|Total|Total of all reporting groups
965110|NCT00912301|B3|Baseline|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965111|NCT00912301|B2|Baseline|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965112|NCT00912301|B1|Baseline|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965113|NCT00912301|P3|Participant Flow|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965114|NCT00912301|P2|Participant Flow|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965115|NCT00912301|P1|Participant Flow|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965116|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965117|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965118|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965119|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965120|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965121|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965122|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965123|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965124|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965125|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965126|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965127|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965128|NCT00912301|O3|Outcome|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965129|NCT00912301|O2|Outcome|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965130|NCT00912301|O1|Outcome|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965131|NCT00912301|E3|Reported Event|Placebo|Participants randomized to this arm received a placebo capsule each day for 4 days.
965132|NCT00912301|E2|Reported Event|NaCDC 1000 mg|Participants randomized to this arm received 1000 mg NaCDC per day for 4 days.
965133|NCT00912301|E1|Reported Event|NaCDC 500 mg|Participants randomized to this arm received 500 mg NaCDC per day for 4 days.
965134|NCT00912288|B3|Baseline|Total|Total of all reporting groups
965135|NCT00912288|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965423|NCT00911612|P1|Participant Flow|Colesevelam|Participants received colesevelam 1.875 g twice daily
965136|NCT00912288|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965137|NCT00912288|P2|Participant Flow|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965138|NCT00912288|P1|Participant Flow|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965139|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965140|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965141|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965142|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965143|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965144|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965145|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965146|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965147|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965148|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965149|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965234|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
965150|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965151|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965152|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965153|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965154|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965155|NCT00912288|O2|Outcome|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965156|NCT00912288|O1|Outcome|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965157|NCT00912288|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
965158|NCT00912288|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
965159|NCT00912223|B1|Baseline|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965160|NCT00912223|P1|Participant Flow|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965161|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965162|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965163|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965164|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965165|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965166|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965167|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965168|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965169|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965170|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965171|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965172|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965173|NCT00912223|O1|Outcome|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965174|NCT00912223|E1|Reported Event|Hematopoietic Stem Cell Transplant|Participants will undergo a non-myeloablative allogeneic hematopoietic stem cell transplant.
965175|NCT00912158|B4|Baseline|Total|Total of all reporting groups
965176|NCT00912158|B3|Baseline|Standard Treatment|Standard medical therapy alone
965177|NCT00912158|B2|Baseline|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
965178|NCT00912158|B1|Baseline|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
965179|NCT00912158|P3|Participant Flow|Standard Treatment|Standard medical therapy alone
965180|NCT00912158|P2|Participant Flow|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
965181|NCT00912158|P1|Participant Flow|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
965182|NCT00912158|O3|Outcome|Standard Treatment|Standard medical therapy alone
965183|NCT00912158|O2|Outcome|BiPAP + ST|Bilevel positive airway pressure + standard medical therapy
965184|NCT00912158|O1|Outcome|CPAP+ST|Continuous positive airway pressure plus standard medical therapy
965185|NCT00912093|B6|Baseline|Total|Total of all reporting groups
965186|NCT00912093|B5|Baseline|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant 30 mg in the controlled phase
965187|NCT00912093|B4|Baseline|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965188|NCT00912093|B3|Baseline|Randomized-Icatibant (Blinded Treatment)--Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
965189|NCT00912093|B2|Baseline|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965235|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
1072659|NCT00632931|O2|Outcome|Placebo|
965190|NCT00912093|B1|Baseline|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
965191|NCT00912093|P5|Participant Flow|Open-Label Icatibant-Severe Laryngeal|Subjects with severe (post-amendment) or mild to severe (pre-amendment) laryngeal attacks of HAE treated with subcutaneous injection of icatibant, 30 mg in the controlled phase
965192|NCT00912093|P4|Participant Flow|Randomized-Placebo (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965193|NCT00912093|P3|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Laryngeal|Subjects with mild to moderate laryngeal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
965194|NCT00912093|P2|Participant Flow|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965195|NCT00912093|P1|Participant Flow|Randomized-Icatibant (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant, 30 mg in the controlled phase
965196|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965197|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
965198|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965199|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
965200|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965201|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
965202|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965203|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
965204|NCT00912093|O2|Outcome|Randomized-Placebo (Blinded Treatment)-Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of matching placebo in the controlled phase
965205|NCT00912093|O1|Outcome|Randomized-Icatibant (Blinded Treatment)--Non-laryngeal|Subjects with moderate to severe cutaneous or abdominal attacks of HAE randomized to receive a single subcutaneous injection of icatibant 30 mg in the controlled phase
965206|NCT00912093|E4|Reported Event|Open Label Extension – Icatibant (Open Label)|Subjects who treated with icatibant 30 mg in the open label extension phase
965207|NCT00912093|E3|Reported Event|Controlled Phase - Icatibant (Open Label)|Subjects who were not randomized and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
965208|NCT00912093|E2|Reported Event|Controlled Phase -Placebo (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of matching placebo in the controlled phase
965209|NCT00912093|E1|Reported Event|Controlled Phase - Icatibant (Randomized)|Subjects who were randomized to treatment and received a single subcutaneous injection of icatibant 30 mg in the controlled phase
965210|NCT00912028|B4|Baseline|Total|Total of all reporting groups
965211|NCT00912028|B3|Baseline|Methafilcon A|"contact lens~methafilcon A: contact lens"
965212|NCT00912028|B2|Baseline|Balafilcon A|"contact lens~balafilcon A: contact lens"
965213|NCT00912028|B1|Baseline|Senofilcon A|"contact lens~senofilcon A: contact lens"
965214|NCT00912028|P5|Participant Flow|Vifilcon A|"contact lens~vifilcon A: contact lens"
965215|NCT00912028|P4|Participant Flow|Methafilcon A|"contact lens~methafilcon A: contact lens"
965216|NCT00912028|P3|Participant Flow|Balafilcon A|"contact lens~balafilcon A: contact lens"
965217|NCT00912028|P2|Participant Flow|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
965218|NCT00912028|P1|Participant Flow|Senofilcon A|"contact lens~senofilcon A: contact lens"
965219|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
965220|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
965221|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
965222|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
965223|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
965224|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
965225|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
965226|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
965227|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
965228|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
965229|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
965230|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
965231|NCT00912028|O3|Outcome|Methafilcon A|"contact lens~methafilcon A: contact lens"
965232|NCT00912028|O2|Outcome|Balafilcon A|"contact lens~balafilcon A: contact lens"
965233|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
965236|NCT00912028|O1|Outcome|Senofilcon A|"contact lens~senofilcon A: contact lens"
965237|NCT00912028|E5|Reported Event|Vifilcon A|"contact lens~vifilcon A: contact lens"
965238|NCT00912028|E4|Reported Event|Methafilcon A|"contact lens~methafilcon A: contact lens"
965239|NCT00912028|E3|Reported Event|Balafilcon A|"contact lens~balafilcon A: contact lens"
965240|NCT00912028|E2|Reported Event|Lotrafilcon B|"contact lens~lotrafilcon B: contact lens"
965241|NCT00912028|E1|Reported Event|Senofilcon A|"contact lens~senofilcon A: contact lens"
965242|NCT00912015|B5|Baseline|Total|Total of all reporting groups
965243|NCT00912015|B4|Baseline|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965244|NCT00912015|B3|Baseline|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965245|NCT00912015|B2|Baseline|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965246|NCT00912015|B1|Baseline|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965247|NCT00912015|P4|Participant Flow|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965248|NCT00912015|P3|Participant Flow|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965249|NCT00912015|P2|Participant Flow|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965250|NCT00912015|P1|Participant Flow|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965251|NCT00912015|O4|Outcome|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965252|NCT00912015|O3|Outcome|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965253|NCT00912015|O2|Outcome|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965254|NCT00912015|O1|Outcome|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965255|NCT00912015|E4|Reported Event|Tramadol OAD 100mg|"All Patients who Received 1x100 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965256|NCT00912015|E3|Reported Event|Tramadol OAD 400mg|"All Patients who Received 1x400 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965257|NCT00912015|E2|Reported Event|Tramadol OAD 300mg|"All Patients who Received 1x300 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965258|NCT00912015|E1|Reported Event|Tramadol OAD 200mg|"All Patients who Received 1x200 mg Tramadol OAD Tablet daily for at Least 350 days.~OAD = Once-A-Day."
965259|NCT00912002|B1|Baseline|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
965260|NCT00912002|P1|Participant Flow|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
965261|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
965262|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
965263|NCT00912002|O1|Outcome|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes as eight 5-mg capsules.
965264|NCT00912002|E1|Reported Event|MK-0941|Oral administration of a single 40-mg dose of [^14C]MK-0941 (160 µCi) to adult male subjects with type 2 diabetes.
965265|NCT00911989|B1|Baseline|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
965266|NCT00911989|P1|Participant Flow|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
965267|NCT00911989|O1|Outcome|Transvaginal Sleeve Gastrectomy|All subjects on whom the surgery was attempted.
965268|NCT00911989|E1|Reported Event|Transvaginal Sleeve Gastrectomy|Transvaginal Sleeve Gastrectomy using Steerable Flex Trocar (SFT) for transvaginal endoscope placement (endoscopic visualization)
965269|NCT00911937|B3|Baseline|Total|Total of all reporting groups
965270|NCT00911937|B2|Baseline|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965271|NCT00911937|B1|Baseline|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965272|NCT00911937|P2|Participant Flow|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965273|NCT00911937|P1|Participant Flow|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965274|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965275|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965276|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965277|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965408|NCT00911625|B3|Baseline|Total|Total of all reporting groups
968422|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
965278|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965279|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965280|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965281|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965282|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965283|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965284|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965285|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965286|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965287|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965288|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965289|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965290|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965291|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965292|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965293|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965294|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965295|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965296|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965297|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965298|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965299|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965300|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965301|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965302|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965303|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965304|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965305|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965306|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965307|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
968423|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
965308|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965309|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965310|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965311|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965312|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965313|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965314|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965315|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965316|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965317|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965318|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965319|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965320|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965321|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965322|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965323|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965324|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965325|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965326|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965327|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965328|NCT00911937|O2|Outcome|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965329|NCT00911937|O1|Outcome|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965330|NCT00911937|E2|Reported Event|Fesoterodine|Fesoterodine 4 mg oral tablet once daily for 4 weeks followed by dose-escalation to 8 mg once daily depending on investigator's discretion for remaining 8 weeks.
965331|NCT00911937|E1|Reported Event|Placebo|Placebo matched to fesoterodine 4 milligram (mg) oral tablet once daily for 4 weeks followed by placebo matched to fesoterodine 8 mg once daily depending on dose escalation as per investigator's discretion for remaining 8 weeks.
965332|NCT00911898|B1|Baseline|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
965333|NCT00911898|P1|Participant Flow|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
965334|NCT00911898|O1|Outcome|MM-111|All participants
965335|NCT00911898|E1|Reported Event|MM-111|MM-111: For Phase 1: Dose-escalation cohorts, drug is administered weekly via IV
965336|NCT00911859|B4|Baseline|Total|Total of all reporting groups
965337|NCT00911859|B3|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965338|NCT00911859|B2|Baseline|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965339|NCT00911859|B1|Baseline|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965340|NCT00911859|P3|Participant Flow|Part 2: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965341|NCT00911859|P2|Participant Flow|Part 2: VMP|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965342|NCT00911859|P1|Participant Flow|Part 1: VMP + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965343|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965344|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965345|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965346|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965347|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965348|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965349|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965350|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965351|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965352|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965353|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965354|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965355|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965356|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965357|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965358|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965359|NCT00911859|O2|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965360|NCT00911859|O1|Outcome|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965361|NCT00911859|E4|Reported Event|Part 2, Maintenance Period: Siltuximab|Siltuximab 8.3 mg/kg or 11 mg/kg as a 1-hour intravenous infusion every 3 weeks, during the maintenance period
965362|NCT00911859|E3|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965363|NCT00911859|E2|Reported Event|Part 2: VMP (Velcade+Melphalan+Prednisone)|Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965775|NCT00910728|P8|Participant Flow|15 mg BID|AZD1480 may be administered orally in capsules
968424|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
965364|NCT00911859|E1|Reported Event|Part 1: VMP (Velcade+Melphalan+Prednisone) + Siltuximab|Siltuximab 11 mg/kg as a 1-hour intravenous infusion every 3 weeks along with VMP. VMP: Velcade 1.3 mg/m2 was administered as an intravenous bolus injection according to the current approved package inserts. Melphalan 9 mg/m2 and prednisone 60 mg/m2 were taken orally.
965365|NCT00911807|B4|Baseline|Total|Total of all reporting groups
965366|NCT00911807|B3|Baseline|Donepezil|
965367|NCT00911807|B2|Baseline|Cerebrolysin|
965368|NCT00911807|B1|Baseline|Cerebrolysin + Donepezil|
965369|NCT00911807|P3|Participant Flow|Donepezil|
965370|NCT00911807|P2|Participant Flow|Cerebrolysin|
965371|NCT00911807|P1|Participant Flow|Cerebrolysin + Donepezil|
965372|NCT00911807|O3|Outcome|Donepezil|
965373|NCT00911807|O2|Outcome|Cerebrolysin|
965374|NCT00911807|O1|Outcome|Cerebrolysin + Donepezil|
965375|NCT00911807|E3|Reported Event|Donepezil|
965376|NCT00911807|E2|Reported Event|Cerebrolysin|
965377|NCT00911807|E1|Reported Event|Cerebrolysin + Donepezil|
965378|NCT00911768|B3|Baseline|Total|Total of all reporting groups
965379|NCT00911768|B2|Baseline|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
965380|NCT00911768|B1|Baseline|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
965381|NCT00911768|P2|Participant Flow|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
965382|NCT00911768|P1|Participant Flow|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
965383|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
965384|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
965385|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
965386|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
965387|NCT00911768|O2|Outcome|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
965388|NCT00911768|O1|Outcome|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
965389|NCT00911768|E2|Reported Event|Placebo|Capsules of corn-starch powder with Korean Red Ginseng flavor 3g administrated twice daily for 8 weeks.
965390|NCT00911768|E1|Reported Event|Korean Red Ginseng|Capsules of Korean Red Ginseng Powder 3g administrated twice daily for 8 weeks.
965391|NCT00911742|B3|Baseline|Total|Total of all reporting groups
965392|NCT00911742|B2|Baseline|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965393|NCT00911742|B1|Baseline|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965394|NCT00911742|P2|Participant Flow|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965395|NCT00911742|P1|Participant Flow|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965396|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965397|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965398|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965399|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965400|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965401|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965402|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965403|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965404|NCT00911742|O2|Outcome|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965405|NCT00911742|O1|Outcome|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965406|NCT00911742|E2|Reported Event|Zytram (R)|"Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965407|NCT00911742|E1|Reported Event|Tramadol Contramid Once A Day|"Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.~OAD: Once-A-Day"
965409|NCT00911625|B2|Baseline|0.25 Units/kg|"Participants randomized to this arm will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.~0.25 units/kg daily insulin: Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
965410|NCT00911625|B1|Baseline|0.5 Units/kg|"Participants randomized to this arm will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.~0.5 units/kg daily insulin: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine."
965411|NCT00911625|P2|Participant Flow|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965412|NCT00911625|P1|Participant Flow|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965413|NCT00911625|O2|Outcome|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965414|NCT00911625|O1|Outcome|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965415|NCT00911625|O2|Outcome|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965416|NCT00911625|O1|Outcome|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965417|NCT00911625|E2|Reported Event|0.25 Units/kg|Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965418|NCT00911625|E1|Reported Event|0.5 Units/kg|Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
965419|NCT00911612|B3|Baseline|Total|Total of all reporting groups
965420|NCT00911612|B2|Baseline|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965421|NCT00911612|B1|Baseline|Colesevelam|Participants received colesevelam 1.875 g twice daily
965422|NCT00911612|P2|Participant Flow|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965424|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965425|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
965426|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965427|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
965428|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965429|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
965430|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965431|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
965432|NCT00911612|O2|Outcome|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965433|NCT00911612|O1|Outcome|Colesevelam|Participants received colesevelam 1.875 g twice daily
965434|NCT00911612|E2|Reported Event|Placebo|Participants received an inert capsule matching the study drug twice daily, as prepared by the Mayo Clinic research pharmacy
965435|NCT00911612|E1|Reported Event|Colesevelam|Participants received colesevelam 1.875 g twice daily
965436|NCT00911547|B5|Baseline|Total|Total of all reporting groups
965437|NCT00911547|B4|Baseline|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965438|NCT00911547|B3|Baseline|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965439|NCT00911547|B2|Baseline|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965440|NCT00911547|B1|Baseline|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965441|NCT00911547|P4|Participant Flow|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965442|NCT00911547|P3|Participant Flow|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965500|NCT00911443|P3|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965443|NCT00911547|P2|Participant Flow|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965444|NCT00911547|P1|Participant Flow|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965445|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965446|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965447|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965448|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965449|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965450|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965451|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965452|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965453|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965454|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965455|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965456|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965457|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965458|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965459|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965460|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965461|NCT00911547|O4|Outcome|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965462|NCT00911547|O3|Outcome|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965463|NCT00911547|O2|Outcome|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965558|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
965464|NCT00911547|O1|Outcome|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965465|NCT00911547|E4|Reported Event|Montelukast+ Beclomethasone|MK 10 mg tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965466|NCT00911547|E3|Reported Event|Beclomethasone|MK placebo tablet orally once daily at bedtime and beclomethasone inhaler 4 puffs (50 μg/puff) upon arising and 4 puffs (50 μg/puff) at bedtime for 16 Weeks. Albuterol inhaler as needed.
965467|NCT00911547|E2|Reported Event|Montelukast|MK 10 mg tablet orally once daily at bedtime. Beclomethasone was removed in a blinded, two-step procedure over 4 weeks: beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965468|NCT00911547|E1|Reported Event|Placebo|Montelukast (MK) placebo tablet orally once daily at bedtime. Beclomethasone (beclo) inhaler was removed in a blinded, two-step procedure over 4 weeks (wks): beclomethasone inhaler 4 puffs (50 μg/puff) upon arising (Weeks 1 to 2)) and 4 puffs (50 μg/puff) at bedtime (Weeks 1 to 4); beclomethasone placebo inhaler 4 puffs upon arising (Weeks 3 to 16) and 4 puffs at bedtime (Weeks 5 to 16). Albuterol inhaler as needed.
965469|NCT00911534|B3|Baseline|Total|Total of all reporting groups
965470|NCT00911534|B2|Baseline|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
965471|NCT00911534|B1|Baseline|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
965472|NCT00911534|P2|Participant Flow|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
965473|NCT00911534|P1|Participant Flow|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
965474|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
965475|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
965476|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
965477|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
1028788|NCT00747344|O1|Outcome|Placebo|
965478|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
965479|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
965480|NCT00911534|O2|Outcome|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
965481|NCT00911534|O1|Outcome|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
965482|NCT00911534|E2|Reported Event|RAB ER 50mg|One RAB ER 50mg capsule, orally, each day for 4 weeks
965483|NCT00911534|E1|Reported Event|Placebo|One placebo capsule, orally, each day for 4 weeks, identical in appearance to the RAB (Rabeprazole) ER (Extended Release) 50mg capsule
965484|NCT00911495|B1|Baseline|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965485|NCT00911495|P1|Participant Flow|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965486|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965487|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965488|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965489|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965490|NCT00911495|O1|Outcome|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965491|NCT00911495|E1|Reported Event|GMI-1070|GMI-1070 administered IV at 20 mg/kg loading dose, followed by a single dose of 10 mg/kg in the evening
965492|NCT00911443|B6|Baseline|Total|Total of all reporting groups
965493|NCT00911443|B5|Baseline|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965494|NCT00911443|B4|Baseline|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965495|NCT00911443|B3|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965496|NCT00911443|B2|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965497|NCT00911443|B1|Baseline|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965498|NCT00911443|P5|Participant Flow|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965499|NCT00911443|P4|Participant Flow|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965501|NCT00911443|P2|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965502|NCT00911443|P1|Participant Flow|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965503|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965504|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965505|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965506|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965507|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965508|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965509|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965510|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965633|NCT00910988|B4|Baseline|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
965511|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965512|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965513|NCT00911443|O5|Outcome|Dacarbazin + Interferon Alpha|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965514|NCT00911443|O4|Outcome|Dacarbazin + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965515|NCT00911443|O3|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 6.4 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 6.4 mg SC from day 8 to 11 and from day 15 to 18 of each 28 cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965516|NCT00911443|O2|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 3.2 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 3.2 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965517|NCT00911443|O1|Outcome|Dacarbazin + Interferon Alpha + Thymosin-alpha-1 1.6 mg|Dacarbazin 800 mg/m2 IV on day 1; Interferon alpha 3MIU SC on day 11 and 18; Thymosin-alpha-1 1.6 mg SC from day 8 to 11 and from day 15 to 18 of each 28 day cycle up to 6 cycles or until progression or unacceptable toxicity develops.
965518|NCT00911326|B1|Baseline|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
965519|NCT00911326|P1|Participant Flow|Lymphoseek|Intraoral and cutaneous (head and neck) squamous cell carcinoma (T1-T4, N0, M0) patients to receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 or 2.0 mCi Tc 99m for sentinel lymph node biopsy and elective neck dissection of cervical lymph nodes.
965520|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
965521|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
965522|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
965523|NCT00911326|O1|Outcome|Intent-to-treat (ITT)|All enrolled patients who were injected with Lymphoseek, who underwent surgery, and had at least one lymph node removed (sentinel or non-sentinel) for which the pathology status (presence/absence of tumor cells) was confirmed.
965524|NCT00911326|E1|Reported Event|Lymphoseek|Enrolled patients who were administered any injection of Lymphoseek.
965525|NCT00911300|B3|Baseline|Total|Total of all reporting groups
965559|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
965560|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
965561|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
965562|NCT00911274|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period.
965526|NCT00911300|B2|Baseline|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965527|NCT00911300|B1|Baseline|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965528|NCT00911300|P2|Participant Flow|Unfractioned Heparin (UFH)/Vitamin K Antagonist (VKA)|Both CN and CP participants received an initial intravenous (i.v.) bolus injection of 70 international units (IU)/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/hour (h) (at least 1250 IU per hour). The infusion dose was adjusted to maintain an activated partial thromboplastin time (aPTT) at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target international normalized ratio (INR) of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965570|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965802|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965529|NCT00911300|P1|Participant Flow|Fondaparinux|For clot-negative (CN) participants (par.), 7.5 milligrams (mg) fondaparinux was injected once daily (OD) subcutaneously (for par. with body weight [BW] 50-100 kilograms [kg]); for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For clot-positive (CP) par. with creatinine clearance (CrCl) >= 50 milliliters (mL)/minute (min), 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965530|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965531|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965532|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965533|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965534|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965535|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965536|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965537|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965538|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965539|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965540|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965541|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965542|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965543|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965563|NCT00911170|B3|Baseline|Total|Total of all reporting groups
965776|NCT00910728|P7|Participant Flow|10 mg BID|AZD1480 may be administered orally in capsules
965544|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965545|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965546|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965632|NCT00910988|B5|Baseline|Total|Total of all reporting groups
965547|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965548|NCT00911300|O2|Outcome|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR &amp;gt;2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965549|NCT00911300|O1|Outcome|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965550|NCT00911300|E2|Reported Event|UFH/VKA|Both CN and CP participants received an initial i.v. bolus injection of 70 IU/kg (at least 5000 IU) UFH, followed by continuous infusion at an initial rate of 15 IU/kg/h (at least 1250 IU per h). The infusion dose was adjusted to maintain an activated partial thromboplastin aPTT at 1.5 to 2 times the reference control value. Infusion continued for at least 72 h. In parallel to UFH, treatment with VKA was started as soon as possible (preferably on Day 1). The dose of VKA was adjusted to reach a target INR of 2.0-3.0. UFH was continued until INR >2.0. Total treatment duration: 28+/-4 days. For CP participants for whom the second TEE showed thrombus disappearance, VKA was continued during cardioversion and up to a total treatment duration of 56+/-4 days.
965551|NCT00911300|E1|Reported Event|Fondaparinux|For CN par., 7.5 mg fondaparinux was injected OD subcutaneously (for par. with BW 50-100 kg; for par. with BW >100 kg, 10 mg fondaparinux was administered using a disposable prefilled syringe for the first 7-10 days after randomization, followed by 3 weeks of 2.5 mg fondaparinux OD (until Day 28+/-4). For CP par. with CrCl >= 50 mL/min, 7.5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 10 mg fondaparinux was administered OD. For CP par. with CrCl 30 to <50 mL/min, 5 mg fondaparinux was injected OD (for par. with BW 50-100 kg); for par. with BW >100 kg, 7.5 mg fondaparinux was injected for 28+/-4 days. If the second TEE showed thrombus disappearance, treatment continued until 7-10 days after the second TEE followed by 3 weeks of 2.5 mg fondaparinux OD (total treatment duration: 56+/-4 days).
965552|NCT00911274|B3|Baseline|Total|Total of all reporting groups
965553|NCT00911274|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
965554|NCT00911274|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
965555|NCT00911274|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
965556|NCT00911274|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by CellCept® 250 mg Capsule dosed in second period.
965557|NCT00911274|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
965564|NCT00911170|B2|Baseline|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965565|NCT00911170|B1|Baseline|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965566|NCT00911170|P2|Participant Flow|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
965567|NCT00911170|P1|Participant Flow|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4). During the long-term follow-up period, further chemotherapy and/or biologic agents (for example, bevacizumab) were to continue at the discretion of the treating physician.
965568|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965569|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965571|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965572|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965573|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965574|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965575|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965576|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965577|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965578|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965579|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965580|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965581|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965582|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965583|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965584|NCT00911170|O2|Outcome|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
1072660|NCT00632931|O1|Outcome|Vorinostat|
965585|NCT00911170|O1|Outcome|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965586|NCT00911170|E2|Reported Event|Pegfilgrastim|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2 and bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus pegfilgrastim 6 mg administered as a single subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965587|NCT00911170|E1|Reported Event|Placebo|Participants received standard chemotherapy (FOLFOX or FOLFIRI) on Days 1-2, plus bevacizumab 5 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle plus placebo subcutaneous injection once per cycle, for a maximum of 4 cycles, 24 hours after chemotherapy (Day 4).
965588|NCT00911157|B3|Baseline|Total|Total of all reporting groups
965589|NCT00911157|B2|Baseline|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
965590|NCT00911157|B1|Baseline|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965591|NCT00911157|P2|Participant Flow|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
965803|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965592|NCT00911157|P1|Participant Flow|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965593|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
965594|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965595|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
965596|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965597|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
965598|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965599|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
965600|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965601|NCT00911157|O2|Outcome|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
972423|NCT00888329|O1|Outcome|Aprepitant|40 mg aprepitant
965602|NCT00911157|O1|Outcome|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965603|NCT00911157|E2|Reported Event|Unfractionated Heparin (UFH)|The dose of UFH was adjusted to maintain activated partial thromboplastin time (APTT) at 1.5-2.5 times control and was administered by intravenous (IV) drip bolus injection followed by IV infusion for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of UFH) was continued up to Day 90 (±7) at a dose adjusted to maintain the PT-INR between 1.5 and 3.0.
965604|NCT00911157|E1|Reported Event|Fondaparinux Sodium (FPX)|The dose of FPX was determined based on a participant's body weight (<50 kg, 5 mg; 50 to 100 kg, 7.5 mg; >100 kg, 10 mg) and was administered once daily by subcutaneous (SC) injection for 5-10 days as a general rule. Concomitant warfarin therapy (administered no later than 72 hours after the first dose of FPX) was continued up to Day 90 (±7) at a dose adjusted to maintain the prothrombin time international normalized ratio (PT-INR) between 1.5 and 3.0.
965605|NCT00911144|B3|Baseline|Total|Total of all reporting groups
965606|NCT00911144|B2|Baseline|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965607|NCT00911144|B1|Baseline|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965608|NCT00911144|P2|Participant Flow|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965609|NCT00911144|P1|Participant Flow|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965610|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965611|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965612|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965613|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965614|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965615|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965616|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965617|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965618|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965619|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965620|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965621|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965622|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965623|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965656|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
965624|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965625|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965626|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965627|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965628|NCT00911144|O2|Outcome|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965629|NCT00911144|O1|Outcome|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965630|NCT00911144|E2|Reported Event|Prevenar Group|Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965631|NCT00911144|E1|Reported Event|Synflorix Group|Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
965634|NCT00910988|B3|Baseline|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
965635|NCT00910988|B2|Baseline|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
965636|NCT00910988|B1|Baseline|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
965637|NCT00910988|P4|Participant Flow|Ziprasidone (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by a ziprasidone injection at the second clamp.
965638|NCT00910988|P3|Participant Flow|Olanzapine (Placebo First)|Subjects from this group received a saline injection at the first clamp followed by an olanzapine injection at the second clamp.
965639|NCT00910988|P2|Participant Flow|Ziprasidone (Drug First)|Subjects from this group received a ziprasidone injection at the first clamp followed by a saline injection at the second clamp.
965640|NCT00910988|P1|Participant Flow|Olanzapine (Drug First)|Subjects from this group received an olanzapine injection at the first clamp followed by a saline injection at the second clamp.
965641|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
965642|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
965643|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
965644|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
965645|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
965646|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
965647|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
965648|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
965649|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
965650|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
965651|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
965652|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
965653|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
965654|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
965655|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
965777|NCT00910728|P6|Participant Flow|70 mg QD|AZD1480 may be administered orally in capsules
965657|NCT00910988|O8|Outcome|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
965658|NCT00910988|O7|Outcome|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
965659|NCT00910988|O6|Outcome|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
965660|NCT00910988|O5|Outcome|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
965661|NCT00910988|O4|Outcome|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
965662|NCT00910988|O3|Outcome|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
965663|NCT00910988|O2|Outcome|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
965664|NCT00910988|O1|Outcome|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
965665|NCT00910988|O8|Outcome|Ziprasidone (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
965666|NCT00910988|O7|Outcome|Ziprasidone (Drug/Placebo)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
965667|NCT00910988|O6|Outcome|Ziprasidone (Placebo/Drug)-Drug|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
965668|NCT00910988|O5|Outcome|Ziprasidone (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
965669|NCT00910988|O4|Outcome|Olanzapine (Placebo/Drug)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
965804|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965670|NCT00910988|O3|Outcome|Olanzapine (Placebo/Drug)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
965671|NCT00910988|O2|Outcome|Olanzapine (Drug/Placebo)-Placebo|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
965672|NCT00910988|O1|Outcome|Olanzapine (Drug/Placebo)-Drug|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
965673|NCT00910988|E8|Reported Event|Normal Saline, Following Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received ziprasidone at the previous visit.
965674|NCT00910988|E7|Reported Event|Ziprasidone, to be Followed by Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) and will receive normal saline at the next visit.
965675|NCT00910988|E6|Reported Event|Ziprasidone, Following Normal Saline|Subjects from this group received ziprasidone (20 mg per IM injection) while having received normal saline at previous visit.
965676|NCT00910988|E5|Reported Event|Normal Saline, to be Followed by Ziprasidone|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive ziprasidone at the next visit.
965677|NCT00910988|E4|Reported Event|Olanzapine, Following Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) while having received normal saline at previous visit.
965678|NCT00910988|E3|Reported Event|Normal Saline, to be Followed by Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) and will receive olanzapine at the next visit.
965679|NCT00910988|E2|Reported Event|Normal Saline, Following Olanzapine|Subjects from this group received 0.9% normal saline (1 ml per IM injection) while having received olanzapine at the previous visit.
965680|NCT00910988|E1|Reported Event|Olanzapine, to be Followed by Normal Saline|Subjects from this group received olanzapine (10 mg per IM injection) and will receive normal saline at the next visit.
965681|NCT00910910|B3|Baseline|Total|Total of all reporting groups
965682|NCT00910910|B2|Baseline|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965683|NCT00910910|B1|Baseline|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965684|NCT00910910|P2|Participant Flow|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965685|NCT00910910|P1|Participant Flow|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965686|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965778|NCT00910728|P5|Participant Flow|50 mg QD|AZD1480 may be administered orally in capsules
972424|NCT00888329|E2|Reported Event|Placebo|Placebo
965687|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965688|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965689|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965690|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965718|NCT00910871|B1|Baseline|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
965805|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965806|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965807|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965691|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965692|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965693|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965694|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965695|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965696|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965697|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965698|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965699|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965700|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965762|NCT00910845|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965779|NCT00910728|P4|Participant Flow|30 mg QD|AZD1480 may be administered orally in capsules
965780|NCT00910728|P3|Participant Flow|10 mg QD|AZD1480 may be administered orally in capsules
965701|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965702|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965703|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965704|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965705|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965706|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965707|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965708|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965709|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965710|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965711|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965712|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965713|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965714|NCT00910910|O2|Outcome|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965763|NCT00910845|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965764|NCT00910728|B10|Baseline|Total|Total of all reporting groups
965765|NCT00910728|B9|Baseline|20 mg QD|AZD1480 may be administered orally in capsules
965715|NCT00910910|O1|Outcome|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965716|NCT00910910|E2|Reported Event|Lenalidomide|For participants with normal renal function [defined as Creatinine Clearance (CrCL ) ≥ 60 mL/min], 5 mg lenalidomide by mouth (PO) once daily (QD) on Days 1 through 28 of the first 28-day cycle, 10 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 15 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until progressive disease (PD) or unacceptable toxicity, whichever occurred first. For participants with moderate renal impairment (defined as CrCL ≥ 30 to < 60 mL/min), 2.5 mg lenalidomide PO QD on Days 1 through 28 of the first 28-day cycle, 5 mg lenalidomide PO QD on Days 1 through 28 starting at cycle 2, 7.5 mg lenalidomide PO QD starting at cycle 3 and for the remainder of the study until PD or unacceptable toxicity, whichever occurred first.
965717|NCT00910910|E1|Reported Event|Chlorambucil|Chlorambucil oral tablets at 0.8 mg/kg on Days 1 and 15 of each 28-day cycle for a total duration of 12 months (approximately 13 cycles).
965795|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965796|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965719|NCT00910871|P1|Participant Flow|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
965720|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
965721|NCT00910871|O1|Outcome|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
965722|NCT00910871|E1|Reported Event|TMC207|Participants will receive 400 milligram (mg) TMC207 tablets orally 2 times a day along with background regimen from Day 1 to Week 2 followed by 200 mg TMC207 tablets orally 3 times a day from Week 3 to Week 24 along with background regimen, then background therapy from Week 25 to end of study (Week 120).
965723|NCT00910858|B4|Baseline|Total|Total of all reporting groups
965724|NCT00910858|B3|Baseline|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965725|NCT00910858|B2|Baseline|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965726|NCT00910858|B1|Baseline|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965727|NCT00910858|P3|Participant Flow|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965766|NCT00910728|B8|Baseline|10 mg BID|AZD1480 may be administered orally in capsules
965767|NCT00910728|B7|Baseline|50 mg QD|AZD1480 may be administered orally in capsules
965768|NCT00910728|B6|Baseline|30 mg QD|AZD1480 may be administered orally in capsules
965769|NCT00910728|B5|Baseline|15 mg BID|AZD1480 may be administered orally in capsules
965728|NCT00910858|P2|Participant Flow|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965729|NCT00910858|P1|Participant Flow|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965797|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965798|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965799|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965800|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965730|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965731|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965732|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
965733|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965734|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965735|NCT00910858|O3|Outcome|Overall|All participants in the Safety population.
965736|NCT00910858|O2|Outcome|Non-responders|Participants who were not erythroid responders.
965737|NCT00910858|O1|Outcome|Responders|Participants with a erythroid response.
965738|NCT00910858|O3|Outcome|10 mg Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965739|NCT00910858|O2|Outcome|15 mg Non-del 5q|"Participants with low- or intermediate-1-risk MDS not associated with a deletion 5q (del 5q) cytogenetic abnormality were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965770|NCT00910728|B4|Baseline|70 mg QD|AZD1480 may be administered orally in capsules
965771|NCT00910728|B3|Baseline|10 mg QD|AZD1480 may be administered orally in capsules
965772|NCT00910728|B2|Baseline|5.0 mg QD|AZD1480 may be administered orally in capsules
965773|NCT00910728|B1|Baseline|2.5 mg QD|AZD1480 may be administered orally in capsules
965774|NCT00910728|P9|Participant Flow|20 mg QD|AZD1480 may be administered orally in capsules
972425|NCT00888329|E1|Reported Event|Aprepitant|40 mg aprepitant
965740|NCT00910858|O1|Outcome|10 mg Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965741|NCT00910858|O2|Outcome|Del 5q|"Participants with a deletion 5q (del 5q) cytogenetic abnormality received 10 mg oral lenalidomide once daily in the Monotherapy Phase. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg of lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965801|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965742|NCT00910858|O1|Outcome|Non-del 5q|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) not associated with a deletion 5q (del 5q) cytogenetic abnormality received 10 or 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~During the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965743|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
965744|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
965745|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
965746|NCT00910858|O1|Outcome|10 mg Lenalidomide|During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily.
965747|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
965748|NCT00910858|O1|Outcome|10 mg Lenalidomide|Participants received a single oral dose of 10 mg lenalidomide on Day -7.
965749|NCT00910858|E2|Reported Event|15 mg Lenalidomide|"Participants with low- or intermediate-1-risk MDS were enrolled directly into the Monotherapy Phase and received 15 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 15 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965750|NCT00910858|E1|Reported Event|10 mg Lenalidomide|"Participants with low- or intermediate-1-risk myelodysplastic syndromes (MDS) received a single 10 mg oral dose of lenalidomide on Day -7 in the Pharmacokinetic Phase.~During the Monotherapy Phase participants received 10 mg oral lenalidomide once daily. Erythroid responders could continue lenalidomide monotherapy in the absence of limiting toxicity, disease progression, or erythroid failure.~After the completion of 16 weeks of lenalidomide monotherapy, in the Combined Treatment Phase participants who were erythroid nonresponders and erythroid responders who had developed an erythroid relapse continued treatment with 10 mg lenalidomide daily in conjunction with recombinant human erythropoietin (rhu EPO) 40,000 units administered weekly by subcutaneous injection for 8 weeks. Responding patients could continue combined treatment."
965751|NCT00910845|B3|Baseline|Total|Total of all reporting groups
965752|NCT00910845|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965753|NCT00910845|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965754|NCT00910845|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965755|NCT00910845|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965756|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965757|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965758|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965759|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965760|NCT00910845|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965761|NCT00910845|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
972426|NCT00888238|B1|Baseline|All Patients|All Randomized patients
965781|NCT00910728|P2|Participant Flow|5.0 mg QD|AZD1480 may be administered orally in capsules
965782|NCT00910728|P1|Participant Flow|2.5 mg QD|AZD1480 may be administered orally in capsules
965783|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965784|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965785|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965786|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965787|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965788|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965789|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965790|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965791|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965792|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965793|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965794|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965808|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965809|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965810|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965811|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965812|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965813|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965814|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965815|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965816|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965817|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965818|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965819|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965820|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965821|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965822|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965823|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965824|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965825|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965826|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965827|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965828|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965829|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965830|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965831|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965832|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965833|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965834|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965835|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965836|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965837|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965838|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965839|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965840|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965841|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965842|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965843|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965844|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965845|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965846|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965847|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965848|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965849|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965850|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965851|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965852|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965853|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965854|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965855|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965856|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965857|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965858|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965859|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965860|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965861|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965862|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965863|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965864|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965865|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965866|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965867|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965868|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965869|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965870|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965871|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965872|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965873|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965874|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965875|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965876|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965877|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965878|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965879|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965880|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965881|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965882|NCT00910728|O9|Outcome|20 mg QD|AZD1480 may be administered orally in capsules
965883|NCT00910728|O8|Outcome|50 mg QD|AZD1480 may be administered orally in capsules
965884|NCT00910728|O7|Outcome|15 mg BID|AZD1480 may be administered orally in capsules
965885|NCT00910728|O6|Outcome|10 mg BID|AZD1480 may be administered orally in capsules
965886|NCT00910728|O5|Outcome|70 mg QD|AZD1480 may be administered orally in capsules
965887|NCT00910728|O4|Outcome|30 mg QD|AZD1480 may be administered orally in capsules
965888|NCT00910728|O3|Outcome|10 mg QD|AZD1480 may be administered orally in capsules
965889|NCT00910728|O2|Outcome|5.0 mg QD|AZD1480 may be administered orally in capsules
965890|NCT00910728|O1|Outcome|2.5 mg QD|AZD1480 may be administered orally in capsules
965891|NCT00910728|E9|Reported Event|10 mg BID|AZD1480 may be administered orally in capsules
965892|NCT00910728|E8|Reported Event|50 mg QD|AZD1480 may be administered orally in capsules
965893|NCT00910728|E7|Reported Event|30 mg QD|AZD1480 may be administered orally in capsules
965894|NCT00910728|E6|Reported Event|20 mg QD|AZD1480 may be administered orally in capsules
965895|NCT00910728|E5|Reported Event|15 mg BID|AZD1480 may be administered orally in capsules
965896|NCT00910728|E4|Reported Event|70 mg QD|AZD1480 may be administered orally in capsules
965897|NCT00910728|E3|Reported Event|10 mg QD|AZD1480 may be administered orally in capsules
965898|NCT00910728|E2|Reported Event|5.0 mg QD|AZD1480 may be administered orally in capsules
965899|NCT00910728|E1|Reported Event|2.5 mg QD|AZD1480 may be administered orally in capsules
965900|NCT00910715|B4|Baseline|Total|Total of all reporting groups
965901|NCT00910715|B3|Baseline|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
965902|NCT00910715|B2|Baseline|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
965903|NCT00910715|B1|Baseline|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
965904|NCT00910715|P3|Participant Flow|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
965905|NCT00910715|P2|Participant Flow|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
965906|NCT00910715|P1|Participant Flow|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
965907|NCT00910715|O2|Outcome|Controls|control subjects without a history of Lyme borreliosis
965908|NCT00910715|O1|Outcome|EM Patients|EM patients treated with doxycycline 100 mg b.i.d. for 10 or 15 days
965909|NCT00910715|O3|Outcome|Controls|subjects without a history of Lyme borreliosis included in the study as controls only at the 6 month follow-up time point, results are given only in the secondary outcome section
965910|NCT00910715|O2|Outcome|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
965911|NCT00910715|O1|Outcome|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
965912|NCT00910715|E3|Reported Event|Controls|subjects without a history of Lyme borreliosis included in the study at the 6 month follow-up time point
965913|NCT00910715|E2|Reported Event|EM-doxycycline 15 Days|doxycycline 100 b.i.d. for 15 days
965914|NCT00910715|E1|Reported Event|EM-10 Days Doxycycline|doxycycline 100 mg b.i.d. for 10 days
965915|NCT00910689|B5|Baseline|Total|Total of all reporting groups
965916|NCT00910689|B4|Baseline|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
965917|NCT00910689|B3|Baseline|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965918|NCT00910689|B2|Baseline|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965919|NCT00910689|B1|Baseline|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965920|NCT00910689|P4|Participant Flow|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
965921|NCT00910689|P3|Participant Flow|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965922|NCT00910689|P2|Participant Flow|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965923|NCT00910689|P1|Participant Flow|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965924|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
965925|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965926|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965927|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965928|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
965929|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965930|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965931|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965932|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
965933|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965934|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965935|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965936|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
966376|NCT00909649|B3|Baseline|Total|Total of all reporting groups
965937|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965938|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965939|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965940|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
965941|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965942|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965943|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965944|NCT00910689|O4|Outcome|OAT + BMM + Beta-B|Optimal Acute Therapy plus Behavioral Migraine Management plus Beta Blocker (propranolol or nadolol)
965945|NCT00910689|O3|Outcome|OAT + BMM + PL|Optimal Acute Therapy plus Behavioral Migraine Management plus placebo
965946|NCT00910689|O2|Outcome|OAT + Beta Blocker (Beta-B)|Optimal Acute Therapy plus Beta Blocker (propranolol or nadolol)
965947|NCT00910689|O1|Outcome|OAT + Placebo (PL)|Optimal Acute Therapy plus Beta Blocker Placebo
965948|NCT00910689|E4|Reported Event|OAT + BMM + Beta-Blocker at Month 5|"Optimal Acute Therapy (OAT)+ Behavioral Migraine Management (BMM)+ Beta-Blocker(Propranolol/Nadolol).~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side effect) assessed after dose adjustment(Month 5)."
965949|NCT00910689|E3|Reported Event|OAT + BMM + PL at Month 5|"Optimal Acute Therapy + Behavioral Migraine Management(BMM) + Beta-Blocker(Propranolol/Nadolol) Placebo.~Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect)as assessed after dose adjustment(Month 5)."
965950|NCT00910689|E2|Reported Event|OAT + Beta-Blocker at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/Nadolol. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or other side-effect assessed after dose adjustment(Month 5).
965951|NCT00910689|E1|Reported Event|OAT + Placebo (PL) at Month 5|Optimal Acute Therapy (OAT) + Beta-Blocker (Propranolol/ Nadolol)Placebo. Side-effects (Fatigue, Gastrointestinal Distress, Insomnia, Lightheaded or Dizzy, Difficulty Concentrating, Depression, Weight Gain, Exercise Intolerance, Nightmares, Drowsiness or Other side effect at Month 5 following dose adjustment.
965952|NCT00910663|B3|Baseline|Total|Total of all reporting groups
965953|NCT00910663|B2|Baseline|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
965954|NCT00910663|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
965955|NCT00910663|P2|Participant Flow|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
965956|NCT00910663|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
965957|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
965958|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
965959|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
965960|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
965961|NCT00910663|O2|Outcome|CellCept® (Reference)|CellCept® 250 mg Capsule dosed in either period.
966000|NCT00910299|P2|Participant Flow|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
965962|NCT00910663|O1|Outcome|Mycophenolate Mofetil (Test)|Mycophenolate Mofetil 250 mg Capsule dosed in either period
965963|NCT00910663|E2|Reported Event|CellCept® (Reference) First|CellCept® 250 mg Capsule dosed in first period followed by Mycophenolate Mofetil 250 mg Capsule dosed in second period.
965964|NCT00910663|E1|Reported Event|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil 250 mg Capsule dosed in first period followed by Cellcept® 250 mg Capsule dosed in second period.
965965|NCT00910624|B5|Baseline|Total|Total of all reporting groups
965966|NCT00910624|B4|Baseline|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965967|NCT00910624|B3|Baseline|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965968|NCT00910624|B2|Baseline|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
966017|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966018|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
965969|NCT00910624|B1|Baseline|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965970|NCT00910624|P4|Participant Flow|BOC + PEG/RBV: Other|Participants who were characterized as “Other” (not in the categories of prior treatment failure as defined by this protocol), after completing treatment on the PEG/RBV control arm on a previous SPRI study, received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965971|NCT00910624|P3|Participant Flow|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965972|NCT00910624|P2|Participant Flow|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965973|NCT00910624|P1|Participant Flow|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at Treatment Week (TW) 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965974|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965975|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965976|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
966001|NCT00910299|P1|Participant Flow|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
1072661|NCT00632931|O2|Outcome|Placebo|
965977|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965978|NCT00910624|O1|Outcome|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965979|NCT00910624|O4|Outcome|BOC + PEG/RBV: All|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965980|NCT00910624|O3|Outcome|BOC + PEG/RBV: Prior Relapsers|Participants who achieved “prior relapse” (defined as undetectable HCV-RNA at end of treatment, and detectable HCV-RNA during follow-up period) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
966019|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966070|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
965981|NCT00910624|O2|Outcome|BOC + PEG/RBV: Prior Partial Responders|Participants who achieved “partial” response (defined as ≥2-log10 decrease in HCV-RNA by TW 12 and detectable HCV-RNA at end of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965982|NCT00910624|O1|Outcome|BOC + PEG/RBV: Prior Null Responders|Participants who achieved “null” response (defined as <2-log10 decrease and detectable HCV RNA at TW 12 of PEG/RBV) after completing treatment on the PEG/RBV control arm on a previous SPRI study received BOC + PEG/RBV on the current study for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who were not able to enroll on the current study within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965983|NCT00910624|E1|Reported Event|All Treated Participants|Participants who enrolled within 2 weeks after the last dose of PEG/RBV in previous SPRI study received boceprevir (BOC) + peginterferon/ribavirin (PEG/RBV) for up to 44 weeks followed by 24 weeks post-treatment follow-up. Participants who did not enroll within 2 weeks after the last dose of PEG/RBV in previous protocol received PEG/RBV for 4 weeks followed by BOC + PEG/RBV for up to 44 weeks, with 24 weeks post-treatment follow-up.
965984|NCT00910520|B3|Baseline|Total|Total of all reporting groups
965985|NCT00910520|B2|Baseline|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965986|NCT00910520|B1|Baseline|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965987|NCT00910520|P2|Participant Flow|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965988|NCT00910520|P1|Participant Flow|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965989|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965990|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965991|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965992|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965993|NCT00910520|O2|Outcome|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965994|NCT00910520|O1|Outcome|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965995|NCT00910520|E2|Reported Event|Placebo/onabotulinumtoxinA|Placebo (normal saline) injected into the detrusor at Day 1, followed by an injection of onabotulinumtoxinA (botulinum toxin Type A) 100 U after a minimum of 12 weeks (if applicable).
965996|NCT00910520|E1|Reported Event|onabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 100 U injected into the detrusor at Day 1, followed by a repeat injection of onabotulinumtoxinA 100 U after a minimum of 12 weeks (if applicable).
965997|NCT00910299|B3|Baseline|Total|Total of all reporting groups
965998|NCT00910299|B2|Baseline|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
965999|NCT00910299|B1|Baseline|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
974146|NCT00884039|E2|Reported Event|15 mg Anecortave Acetate|
966002|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
966003|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
966004|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
966005|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
966006|NCT00910299|O2|Outcome|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
966007|NCT00910299|O1|Outcome|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
966008|NCT00910299|E2|Reported Event|Clopidogrel|75 mg oral daily maintenance dose up to 6 months.
966009|NCT00910299|E1|Reported Event|Prasugrel|One time 60 milligram (mg) oral loading dose and 10 mg once daily oral maintenance dose up to 6 months
966010|NCT00910273|B3|Baseline|Total|Total of all reporting groups
966011|NCT00910273|B2|Baseline|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966012|NCT00910273|B1|Baseline|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966013|NCT00910273|P2|Participant Flow|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966014|NCT00910273|P1|Participant Flow|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966015|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966016|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966377|NCT00909649|B2|Baseline|Non Fibrin Group|
966020|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966021|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966022|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966023|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966024|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966025|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966026|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966027|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966028|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966029|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966030|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966031|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966032|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966033|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966034|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966035|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966036|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966037|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966038|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966039|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966040|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966041|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966042|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966043|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966044|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966045|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966046|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966047|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966048|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966049|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966050|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966051|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966355|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966052|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966053|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966054|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966055|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966056|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966057|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966058|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966059|NCT00910273|O2|Outcome|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966060|NCT00910273|O1|Outcome|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966061|NCT00910273|E2|Reported Event|Placebo|Participants received matched placebo sc injection once per week for 52 weeks.
966062|NCT00910273|E1|Reported Event|Etanercept|Participants received etanercept (50 milligrams [mg]) subcutaneous (sc) injection once per week for 52 weeks.
966063|NCT00910091|B3|Baseline|Total|Total of all reporting groups
966064|NCT00910091|B2|Baseline|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966065|NCT00910091|B1|Baseline|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966066|NCT00910091|P2|Participant Flow|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
966067|NCT00910091|P1|Participant Flow|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966068|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966069|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966071|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966072|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966073|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966074|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966075|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966076|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966077|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966078|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966079|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966080|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966081|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966082|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966083|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966084|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966085|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966086|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966087|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966088|NCT00910091|O2|Outcome|Arm B: MA 160 mg|Megestrol Acetate (MA) 160 mg tablet by mouth once daily
966089|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966090|NCT00910091|O2|Outcome|Arm B: MA 160 mg|MA 160 mg tablet by mouth once daily
966091|NCT00910091|O1|Outcome|Arm A: BN83495 40 mg|BN83495 (Irosustat) 40 mg tablet by mouth once daily
966092|NCT00910091|E2|Reported Event|B- MA - 160mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~Megestrol Acetate (MA): MA will be administered orally as 160mg daily"
966093|NCT00910091|E1|Reported Event|A- BN 83495- 40mg|"After eligibility is confirmed, subjects will be randomised at baseline. The randomisation number and associated treatment for the total study will be allocated by an Interactive Voice Response System (IVRS) service~BN83495: BN83495 will be administered as a 40 mg tablet once a day orally"
966094|NCT00910039|B1|Baseline|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966095|NCT00910039|P1|Participant Flow|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966096|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966097|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966098|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg) once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966099|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966100|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966101|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966102|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966137|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
966139|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
966103|NCT00910039|O1|Outcome|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966104|NCT00910039|E1|Reported Event|Sunitinib Malate|"Oral sunitinib malate (37.5mg)once daily on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~Patients undergo neuropsychological battery testing at baseline and periodically during study to assess cognitive function (memory, verbal fluency, visual-motor speed, executive function, and motor dexterity), activities of daily living, and quality of life."
966105|NCT00910000|B7|Baseline|Total|Total of all reporting groups
966106|NCT00910000|B6|Baseline|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966107|NCT00910000|B5|Baseline|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966108|NCT00910000|B4|Baseline|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966109|NCT00910000|B3|Baseline|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966110|NCT00910000|B2|Baseline|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966111|NCT00910000|B1|Baseline|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966112|NCT00910000|P6|Participant Flow|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966113|NCT00910000|P5|Participant Flow|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966114|NCT00910000|P4|Participant Flow|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966115|NCT00910000|P3|Participant Flow|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966116|NCT00910000|P2|Participant Flow|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966117|NCT00910000|P1|Participant Flow|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966118|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966138|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
966378|NCT00909649|B1|Baseline|Fibrin Group|
966119|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966120|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966121|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966122|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966123|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966124|NCT00910000|O6|Outcome|Dose Level 2D|"Vorinostat: 400mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966125|NCT00910000|O5|Outcome|Dose Level 1D|"Vorinostat: 300mg, taken orally once a day for days 1 and 2 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966126|NCT00910000|O4|Outcome|Dose Level 1C|"Vorinostat: 200mg, taken orally twice a day for days 1, 2, 8 and 9 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 2 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 2 and day 9 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966127|NCT00910000|O3|Outcome|Dose Level 1B|"Vorinostat: 200mg, taken orally twice a day for days 1-3 and days 8-10 of every three week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966128|NCT00910000|O2|Outcome|Dose Level 2A|"Vorinostat: 300mg, taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 1000 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966129|NCT00910000|O1|Outcome|Dose Level 1A|"Vorinostat: 200 mg taken orally once a day for the first two weeks of each three-week cycle~Carboplatin: AUC 4, given intravenously on day 1 of every three week cycle~Gemcitabine: 100 mg/m2, given intravenously on day 1 and day 8 of every three week cycle~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966162|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966356|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
966130|NCT00910000|O1|Outcome|All Phase Ib Participants|"All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9).~Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision."
966131|NCT00910000|E1|Reported Event|All Phase Ib Participants|All Phase Ib participants received Vorinostat according to the established dose escalation schedule during a 3-week cycle in combination with IV carboplatin AUC 4 (day 2) and IV gemcitabine 1000 mg/m2 (days 2 and 9). Participants received up to 8 cycles of therapy without the occurrence of disease progression, unacceptable adverse events, patient withdrawal, or discontinuation per MD decision.
966132|NCT00909870|B3|Baseline|Total|Total of all reporting groups
966133|NCT00909870|B2|Baseline|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
966134|NCT00909870|B1|Baseline|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
966135|NCT00909870|P2|Participant Flow|Active Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
966136|NCT00909870|P1|Participant Flow|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
966379|NCT00909649|P2|Participant Flow|Non Fibrin Group|
966140|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of=- Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
966141|NCT00909870|O2|Outcome|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
966142|NCT00909870|O1|Outcome|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
966143|NCT00909870|E2|Reported Event|Control (Standard-of-Care)|Weekly application of compression dressings only, in combination with systematic surgical wound debridement.
966144|NCT00909870|E1|Reported Event|Investigational Treatment (Dermagraft Plus Standard-of-Care)|Weekly applications of Dermagraft and compression dressings, in combination with systematic surgical wound debridement.
966145|NCT00909857|B3|Baseline|Total|Total of all reporting groups
966146|NCT00909857|B2|Baseline|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966147|NCT00909857|B1|Baseline|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966148|NCT00909857|P2|Participant Flow|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966149|NCT00909857|P1|Participant Flow|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966150|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966151|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966152|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966153|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966154|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966155|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966156|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966157|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966158|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966159|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966160|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966161|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
1072662|NCT00632931|O1|Outcome|Vorinostat|
966163|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966164|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966165|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966166|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966167|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966168|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966169|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966170|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966171|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966372|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966380|NCT00909649|P1|Participant Flow|Fibrin Group|
966172|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966173|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966174|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966175|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966176|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966177|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966178|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966179|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966180|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966181|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966182|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966183|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966184|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966185|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966186|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966187|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966188|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966189|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966190|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966191|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966192|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966345|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966346|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
966193|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966194|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966195|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966196|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966197|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966198|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966199|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966200|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966201|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966202|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966203|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966204|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966205|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966206|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966207|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966208|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966209|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966210|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966211|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966212|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966213|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966214|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966215|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966216|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966217|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966218|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966219|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966220|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966221|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966222|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966347|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966348|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
966223|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966224|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966225|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966226|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966227|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966228|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966229|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966230|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966231|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966232|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966233|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966234|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966235|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966236|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966237|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966238|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966239|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966240|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966241|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966242|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966243|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966244|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966245|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966246|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966247|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966248|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966249|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966250|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966251|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966252|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966349|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966350|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
966253|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966254|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966255|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966256|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966257|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966258|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966259|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966260|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966261|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966262|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966263|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966264|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966265|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966266|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966267|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966268|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966269|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966270|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966271|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966272|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966273|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966274|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966275|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966276|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966277|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966278|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966279|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966280|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966281|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966282|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966351|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966352|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
966283|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966284|NCT00909857|O2|Outcome|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966285|NCT00909857|O1|Outcome|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966286|NCT00909857|E2|Reported Event|Ethinyl Estradiol, Levonorgestrel (Miranova)|Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles
966287|NCT00909857|E1|Reported Event|Estradiol Valerate, Dienogest (Natazia, Qlaira, BAY86-5027)|Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles
966288|NCT00909844|B1|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
966289|NCT00909844|P1|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
966290|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966373|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966381|NCT00909649|O2|Outcome|Non Fibrin Group|
966291|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966292|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966293|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966294|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966295|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966296|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966297|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966298|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966299|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966300|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966301|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966302|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966303|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via i.m. injection once every 3 months from Baseline until end of the study treatment.
966304|NCT00909844|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
966305|NCT00909844|E1|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate (prolonged release formulation) was administered via intramuscular (i.m.) injection once every 3 months from Baseline until end of the study treatment.
966306|NCT00909792|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
966307|NCT00909792|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lenses worn first, with Lotrafilcon B multifocal contact lenses worn second. Both products worn in a daily wear basis.
966308|NCT00909792|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lenses worn first, with Senofilcon A multifocal contact lenses worn second. Both products worn in a daily wear basis.
966309|NCT00909792|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
966310|NCT00909792|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
966311|NCT00909792|E2|Reported Event|Senofilcon A|Silicone hydrogel, soft, multifocal contact lens
966312|NCT00909792|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens
966313|NCT00909779|B3|Baseline|Total|Total of all reporting groups
966314|NCT00909779|B2|Baseline|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966315|NCT00909779|B1|Baseline|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966353|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966354|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
966316|NCT00909779|P2|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966317|NCT00909779|P1|Participant Flow|Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966318|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966319|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966320|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966321|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966374|NCT00909727|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966375|NCT00909727|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966322|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966323|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966324|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966325|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966326|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966327|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966328|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966329|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966330|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966331|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966332|NCT00909779|O2|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966333|NCT00909779|O1|Outcome|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatent of COPD symptoms.
966334|NCT00909779|O2|Outcome|Placebo|Placebo twice daily
966335|NCT00909779|O1|Outcome|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966336|NCT00909779|E2|Reported Event|Experimental: Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966337|NCT00909779|E1|Reported Event|Placebo Comparator: Placebo Twice Daily|Placebo twice daily by nebulization. All subjects will be dispensed albuterol HFA metered-dose inhaler (MDI) to be used as needed as rescue medication for bronchospasm and acute treatment of COPD symptoms.
966338|NCT00909753|B3|Baseline|Total|Total of all reporting groups
966339|NCT00909753|B2|Baseline|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
966340|NCT00909753|B1|Baseline|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
966341|NCT00909753|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
966342|NCT00909753|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by UrsoForte™ Tablets, 500 mg (reference) dosed in second period.
966343|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966344|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
974147|NCT00884039|E1|Reported Event|30 mg Anecortave Acetate|
966357|NCT00909753|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg dosed in either period
966358|NCT00909753|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg dosed in either period
966359|NCT00909727|B3|Baseline|Total|Total of all reporting groups
966360|NCT00909727|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966361|NCT00909727|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966362|NCT00909727|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966363|NCT00909727|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966364|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966365|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966366|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966367|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966368|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966369|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966370|NCT00909727|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks
966371|NCT00909727|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks
966382|NCT00909649|O1|Outcome|Fibrin Group|
966383|NCT00909610|B3|Baseline|Total|Total of all reporting groups
966384|NCT00909610|B2|Baseline|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
966385|NCT00909610|B1|Baseline|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
966386|NCT00909610|P2|Participant Flow|Urso Forte™ (Reference) First|Urso Forte™ Tablets, 500 mg (reference) dosed in first period followed by Ursodiol Tablets, 500 mg (test) dosed in second period.
966387|NCT00909610|P1|Participant Flow|Ursodiol (Test) First|Ursodiol Tablets, 500 mg (test) dosed in first period followed by Urso Forte™ Tablets, 500 mg (reference) dosed in second period.
966388|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966389|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
966390|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966391|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
966392|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966393|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
966394|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966395|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
966396|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966397|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
966398|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966399|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
966400|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966401|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period.
966402|NCT00909610|O2|Outcome|Urso Forte™|Urso Forte™ Tablets, 500 mg (reference) dosed in either period.
966403|NCT00909610|O1|Outcome|Ursodiol|Ursodiol Tablets, 500 mg (test) dosed in either period
966404|NCT00909545|B5|Baseline|Total|Total of all reporting groups
966405|NCT00909545|B4|Baseline|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966406|NCT00909545|B3|Baseline|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966407|NCT00909545|B2|Baseline|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966408|NCT00909545|B1|Baseline|Placebo|4 Placebo to Match (PTM) tablets once daily
966409|NCT00909545|P4|Participant Flow|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
966410|NCT00909545|P3|Participant Flow|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966411|NCT00909545|P2|Participant Flow|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966412|NCT00909545|P1|Participant Flow|Placebo|4 Placebo to Match (PTM) tablets once daily
966413|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966414|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966415|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966416|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966417|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966418|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966419|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
1084980|NCT00603525|O1|Outcome|Placebo|
966420|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966421|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966422|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966423|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966424|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966425|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966426|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966427|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966428|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966429|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966430|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966431|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966432|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966433|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966434|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966435|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966436|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966437|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966438|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966439|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966440|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966441|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966442|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966443|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966444|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966445|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966446|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966447|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966448|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966449|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966450|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966451|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966452|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966453|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966454|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966455|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966456|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966457|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966458|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966459|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966460|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966461|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966462|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966463|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966464|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966465|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966466|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966467|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966468|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966469|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966470|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966471|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966472|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966473|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966474|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966475|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966476|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966477|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966478|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966479|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966480|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966481|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966482|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966483|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966484|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966485|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966486|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966487|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966488|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966489|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966490|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966491|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966492|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966493|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966494|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966495|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966496|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966497|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966498|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966499|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966500|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966501|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966502|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966503|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966504|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966505|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966506|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966507|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966751|NCT00908648|B3|Baseline|Total|Total of all reporting groups
966508|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966509|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966510|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966511|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966512|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966513|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966514|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966515|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966516|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966517|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966518|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966519|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966520|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966521|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966522|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966523|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966524|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966525|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966526|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966527|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966528|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966529|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966530|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966531|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966532|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966533|NCT00909545|O4|Outcome|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966534|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966535|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966536|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966537|NCT00909545|O4|Outcome|Isradipine CR 15-20mg/Day|3-4 Dynacirc CR 5mg tablets once daily
966538|NCT00909545|O3|Outcome|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966539|NCT00909545|O2|Outcome|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966540|NCT00909545|O1|Outcome|Placebo|4 Placebo to Match (PTM) tablets once daily
966541|NCT00909545|E4|Reported Event|Isradipine CR 20mg/Day|4 Dynacirc CR 5mg tablets once daily
966542|NCT00909545|E3|Reported Event|Isradipine CR 10mg/Day|2 Dynacirc CR 5mg tablets, 2 tablets placebo once daily
966543|NCT00909545|E2|Reported Event|Isradipine CR 5mg/Day|1 Dynacirc CR 5mg tablet, 3 tablets placebo once daily
966544|NCT00909545|E1|Reported Event|Placebo|4 Placebo to Match (PTM) tablets once daily
966545|NCT00909532|B3|Baseline|Total|Total of all reporting groups
966546|NCT00909532|B2|Baseline|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966547|NCT00909532|B1|Baseline|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966548|NCT00909532|P2|Participant Flow|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966549|NCT00909532|P1|Participant Flow|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966550|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966551|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966552|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966553|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966554|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966555|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966556|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966557|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966558|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablets of 150 mg of ivacaftor q12h for up to 48 weeks.
966559|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966560|NCT00909532|O2|Outcome|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966561|NCT00909532|O1|Outcome|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966562|NCT00909532|E2|Reported Event|150 mg Ivacaftor q12h|Oral tablet of 150 mg of ivacaftor q12h for up to 48 weeks.
966563|NCT00909532|E1|Reported Event|Placebo|Oral tablet every 12 hours (q12h) for up to 48 weeks.
966564|NCT00909480|B3|Baseline|Total|Total of all reporting groups
966565|NCT00909480|B2|Baseline|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966566|NCT00909480|B1|Baseline|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966567|NCT00909480|P2|Participant Flow|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966568|NCT00909480|P1|Participant Flow|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966569|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966570|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966571|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966572|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966573|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966574|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966575|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966576|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966577|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966578|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966579|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966580|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966581|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966582|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966583|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966584|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966585|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966586|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966587|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966588|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966589|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966590|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966591|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966592|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966593|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966594|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966595|NCT00909480|O2|Outcome|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966596|NCT00909480|O1|Outcome|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966597|NCT00909480|E2|Reported Event|IGlar|Individually adjusted insulin glargine once daily + metformin at least 1500 mg/day
966598|NCT00909480|E1|Reported Event|IDet|Individually adjusted insulin detemir once daily + metformin at least 1500 mg/day
966599|NCT00909428|B4|Baseline|Total|Total of all reporting groups
966600|NCT00909428|B3|Baseline|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
966601|NCT00909428|B2|Baseline|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
966602|NCT00909428|B1|Baseline|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
966603|NCT00909428|P3|Participant Flow|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
966604|NCT00909428|P2|Participant Flow|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
967279|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
966605|NCT00909428|P1|Participant Flow|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI).
966606|NCT00909428|O2|Outcome|One Month Maximal Cystometric Capacity|All patients with DOI or USI had their maximal cystometric capacity recorded following 30 days of treatment with daily 10mg solifenacin succinate.
966607|NCT00909428|O1|Outcome|Baseline Maximal Cystometric Capacity|All patients with DOI or USI had their baseline maximal cystometric capacity recorded
966608|NCT00909428|E3|Reported Event|Mixed Incontinence (DOI-USI)|Patients in this cohort were diagnosed with both detrusor overactivity incontinence (DOI) and urodynamic stress incontinence (USI)
966609|NCT00909428|E2|Reported Event|Urodynamic Stress Incontinence (USI)|Patients in this cohort were diagnosed with urodynamic stress incontinence (USI)
966610|NCT00909428|E1|Reported Event|Detrusor Overactivity Incontinence (DOI)|Patients in this cohort were diagnosed with detrusor overactivity incontinence (DOI)
966611|NCT00909389|B1|Baseline|Filipino Patients With Hypercholesterolemia|
966612|NCT00909389|P1|Participant Flow|Filipino Patients With Hypercholesterolemia|
966613|NCT00909389|O1|Outcome|Filipino Patients With Hypercholesterolemia|
966614|NCT00909389|E1|Reported Event|Filipino Patients With Hypercholesterolemia|
966615|NCT00909324|B3|Baseline|Total|Total of all reporting groups
966616|NCT00909324|B2|Baseline|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
966617|NCT00909324|B1|Baseline|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
966618|NCT00909324|P2|Participant Flow|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
966696|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
966619|NCT00909324|P1|Participant Flow|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
966620|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
966621|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
966622|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
966623|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
966624|NCT00909324|O2|Outcome|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
966625|NCT00909324|O1|Outcome|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
966626|NCT00909324|E2|Reported Event|Post-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.
966627|NCT00909324|E1|Reported Event|Pre-LASIK 0.3% Hypromellose|Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery.
966628|NCT00909181|B4|Baseline|Total|Total of all reporting groups
966629|NCT00909181|B3|Baseline|Placebo Gel|
966630|NCT00909181|B2|Baseline|Oxybutynin Gel 84 mg/Day|
966631|NCT00909181|B1|Baseline|Oxybutynin Gel 56 mg/Day|
966632|NCT00909181|P3|Participant Flow|Placebo Gel|
966633|NCT00909181|P2|Participant Flow|Oxybutynin Gel 84 mg/Day|
966634|NCT00909181|P1|Participant Flow|Oxybutynin Gel 56 mg/Day|
966635|NCT00909181|O3|Outcome|Placebo Gel|
966636|NCT00909181|O2|Outcome|Oxybutynin Gel 84 mg/Day|
966637|NCT00909181|O1|Outcome|Oxybutynin Gel 56 mg/Day|
966638|NCT00909181|E3|Reported Event|Placebo Gel|
966639|NCT00909181|E2|Reported Event|Oxybutynin Gel 84 mg/Day|
966640|NCT00909181|E1|Reported Event|Oxybutynin Gel 56 mg/Day|
966641|NCT00909155|B4|Baseline|Total|Total of all reporting groups
966642|NCT00909155|B3|Baseline|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
966643|NCT00909155|B2|Baseline|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
966644|NCT00909155|B1|Baseline|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
966645|NCT00909155|P3|Participant Flow|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
966646|NCT00909155|P2|Participant Flow|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
967701|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
966647|NCT00909155|P1|Participant Flow|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine extended release tablets (Venlafaxine ERT).~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
966648|NCT00909155|O3|Outcome|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
966649|NCT00909155|O2|Outcome|Currently Depressed Subjects: Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
966650|NCT00909155|O1|Outcome|Currently Depressed Subjects: Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
966651|NCT00909155|E3|Reported Event|Control (Non-psychiatric Subjects)|Non-psychiatric subjects with no past or current history of depression. Subjects will receive no medication
966652|NCT00909155|E2|Reported Event|Currently Depressed Subjects; Fluoxetine|"Currently depressed subjects; Randomized medication treatment with Fluoxetine~Fluoxetine: Titrated to a minimum dose of 20mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 20mg; Days 7-14: 20mg; Days 15-180: 20-80mg based on clinician assessment. Titration rate is a maximum of 20mg/7d"
966653|NCT00909155|E1|Reported Event|Currently Depressed Subjects; Venlafaxine|"Currently depressed subjects; Randomized medication treatment with Venlafaxine ERT.~Venlafaxine ERT: Titrated to a minimum dose of 75mg. Further titration based on clinician assessment at followup visits. Intervention to continue through completion of study (180 days). Initial titration: Days 1-7: 37.5 mg; Days 7-14: 75 mg; Days 15-180: 75-300mg based on clinician assessment. Titration rate is a maximum of 75mg/7d."
966654|NCT00909064|B1|Baseline|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
966655|NCT00909064|P1|Participant Flow|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
966656|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
966657|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
966658|NCT00909064|O1|Outcome|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
966659|NCT00909064|E1|Reported Event|Arixtra|"Effect of Arixtra on would drainage and length of stay for the patients with hip and knee replacement~Fondaparinux Sodium (Arixtra): 2.5 mg once per day to begin 6-8 hours after surgery and continued for 10 days."
966660|NCT00909038|B1|Baseline|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966661|NCT00909038|P1|Participant Flow|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966662|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966663|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966664|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966665|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966666|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966667|NCT00909038|O1|Outcome|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966668|NCT00909038|E1|Reported Event|Telmisartan (T) 80mg/Hydrochlorothiazide (HCTZ) 25 mg|Patients treated at least 8 weeks with Fixed Dose Combination (FDC)
966669|NCT00908960|B4|Baseline|Total|Total of all reporting groups
966670|NCT00908960|B3|Baseline|Arm C (Low TFMP)|Observation
966671|NCT00908960|B2|Baseline|Arm B (High TFMP)|Observation
966672|NCT00908960|B1|Baseline|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
966673|NCT00908960|P3|Participant Flow|Arm C (Low TFMP)|Observation
966674|NCT00908960|P2|Participant Flow|Arm B (High TFMP)|Observation
966675|NCT00908960|P1|Participant Flow|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
966676|NCT00908960|O3|Outcome|Arm C (Low TFMP)|Observation
966677|NCT00908960|O2|Outcome|Arm B (High TFMP)|Observation
966678|NCT00908960|O1|Outcome|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
966679|NCT00908960|E3|Reported Event|Arm C (Low TFMP)|Observation
966680|NCT00908960|E2|Reported Event|Arm B (High TFMP)|Observation
966681|NCT00908960|E1|Reported Event|Arm A (High TFMP)|Enoxaparin given subcutaneously daily for 2 months
966682|NCT00908908|B1|Baseline|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
967702|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
966683|NCT00908908|P1|Participant Flow|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
966684|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
966685|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
966686|NCT00908908|O1|Outcome|14C-eribulin/Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
966687|NCT00908908|E1|Reported Event|Eribulin|Cycle 1 Day 1: radio-labeled dose of 2 mg radioactive eribulin, followed by 1.4 mg/m^2 of non-radio-labeled eribulin thereafter on Days 1 and 8 every 21 days.
966688|NCT00908895|B3|Baseline|Total|Total of all reporting groups
966689|NCT00908895|B2|Baseline|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
966690|NCT00908895|B1|Baseline|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
966691|NCT00908895|P2|Participant Flow|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
966692|NCT00908895|P1|Participant Flow|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
966693|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
966694|NCT00908895|O1|Outcome|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
966695|NCT00908895|O2|Outcome|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
966697|NCT00908895|E2|Reported Event|Percutaneous Pinning|Two K-wires inserted on a percutaneous way (dorsally and from the styloid), with a cast for 6 weeks
966698|NCT00908895|E1|Reported Event|Radio-radial Fixator|Patients are operated on using a radio-radial fixator (Distal radius fixator, Synthes)
966699|NCT00908882|B3|Baseline|Total|Total of all reporting groups
966700|NCT00908882|B2|Baseline|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966701|NCT00908882|B1|Baseline|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966702|NCT00908882|P2|Participant Flow|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966703|NCT00908882|P1|Participant Flow|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966704|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966705|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966706|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966707|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966708|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966709|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966710|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966711|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966712|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966871|NCT00908141|E1|Reported Event|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
966713|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966714|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966715|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966716|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966717|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966718|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966749|NCT00908687|E2|Reported Event|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966750|NCT00908687|E1|Reported Event|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
966719|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966720|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966721|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966722|NCT00908882|O2|Outcome|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke and receive standard of care for smoking cessation and use the standard PTSD Health Buddy
966723|NCT00908882|O1|Outcome|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke and are exposed to a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966724|NCT00908882|E2|Reported Event|Usual PTSD Health Buddy Care|Veteran with PTSD who smoke received standard of care for smoking cessation and use the standard PTSD Health Buddy
966725|NCT00908882|E1|Reported Event|Enhanced PTSD Health Buddy and Motivational Interviewing|"Veterans with PTSD who smoke are exposed to an intervention which included a 90-day smoking cessation curriculum that is integrated into the PTSD Health Buddy Program and weekly motivational interviewing counseling by a nurse plus usual smoking cessation care~Motivation Interviewing Counseling: Stage-based smoking cessation information written in the spirit of motivational interviewing in addition to weekly telephonic motivational interviewing counseling sessions"
966726|NCT00908687|B7|Baseline|Total|Total of all reporting groups
966727|NCT00908687|B6|Baseline|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966728|NCT00908687|B5|Baseline|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966729|NCT00908687|B4|Baseline|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
966730|NCT00908687|B3|Baseline|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966731|NCT00908687|B2|Baseline|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966732|NCT00908687|B1|Baseline|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
966733|NCT00908687|P6|Participant Flow|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966734|NCT00908687|P5|Participant Flow|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966735|NCT00908687|P4|Participant Flow|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
966736|NCT00908687|P3|Participant Flow|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966737|NCT00908687|P2|Participant Flow|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966738|NCT00908687|P1|Participant Flow|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
966872|NCT00908128|B3|Baseline|Total|Total of all reporting groups
966739|NCT00908687|O6|Outcome|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966740|NCT00908687|O5|Outcome|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966741|NCT00908687|O4|Outcome|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
966742|NCT00908687|O3|Outcome|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966743|NCT00908687|O2|Outcome|Group 2: 30 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966744|NCT00908687|O1|Outcome|Group 1: 30 µg HA, no LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. on Day 0~A/H5N1: A/H5N1 Low Dose"
966745|NCT00908687|E6|Reported Event|Group 6: 45 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966746|NCT00908687|E5|Reported Event|Group 5: 45 µg HA + 50 µg LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. + LT adjuvant patch containing 50 µg of LT on Day 0~A/H5N1: A/H5N1 High Dose~LT Adjuvant Patch: LT Adjuvant Patch Low Dose"
966747|NCT00908687|E4|Reported Event|Group 4: 45 µg HA, no LT Patch|"A/H5N1 Vaccine 45 µg HA i.m. on Day 0~A/H5N1: A/H5N1 High Dose"
966748|NCT00908687|E3|Reported Event|Group 3: 30 µg HA + 100 µg LT Patch|"A/H5N1 Vaccine 30 µg HA i.m. + LT adjuvant patch containing 100 µg of LT on Day 0~A/H5N1: A/H5N1 Low Dose~LT Adjuvant Patch: LT Adjuvant Patch High Dose"
966752|NCT00908648|B2|Baseline|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
966753|NCT00908648|B1|Baseline|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
966754|NCT00908648|P2|Participant Flow|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
966755|NCT00908648|P1|Participant Flow|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
966756|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
966757|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
966758|NCT00908648|O2|Outcome|Narrow Band Imaging|use of narrow band imaging during the withdrawal phase of colonoscopy
966759|NCT00908648|O1|Outcome|Standard White Light|use of standard white light during the withdrawal phase of colonoscopy
966760|NCT00908596|B5|Baseline|Total|Total of all reporting groups
966761|NCT00908596|B4|Baseline|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966762|NCT00908596|B3|Baseline|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966763|NCT00908596|B2|Baseline|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966764|NCT00908596|B1|Baseline|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966765|NCT00908596|P4|Participant Flow|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966766|NCT00908596|P3|Participant Flow|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966767|NCT00908596|P2|Participant Flow|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966768|NCT00908596|P1|Participant Flow|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966769|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966770|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966771|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966772|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966773|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
974148|NCT00883779|B3|Baseline|Total|Total of all reporting groups
966774|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966775|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966776|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966777|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966778|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966779|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966780|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966781|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966782|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966783|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966784|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966785|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966786|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966787|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966788|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966789|NCT00908596|O4|Outcome|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966790|NCT00908596|O3|Outcome|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966791|NCT00908596|O2|Outcome|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966792|NCT00908596|O1|Outcome|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966793|NCT00908596|E4|Reported Event|Gadoxetic Acid Disodium - Severe Renal Impairment|Participants on dialysis or if not on dialysis with eGFR prior to Primovist/Eovist injection < 30 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966794|NCT00908596|E3|Reported Event|Gadoxetic Acid Disodium - Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between ≥ 30 and ≤ 59 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966795|NCT00908596|E2|Reported Event|Gadoxetic Acid Disodium - Extended Moderate Renal Impairment|Participants with eGFR prior to Primovist/Eovist injection between > 59 and ≤ 65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966796|NCT00908596|E1|Reported Event|Gadoxetic Acid Disodium - Mild Renal Impairment|Participants with eGFR (estimated glomerular filtration rate) prior to Primovist/Eovist injection >65 mL/min/1.73 m^2. Participants received Primovist/Eovist as part of their routine medical care.
966797|NCT00908583|B1|Baseline|All Study Participants|Combined study participants, all phases.
966798|NCT00908583|P1|Participant Flow|All Study Participants|Combined study participants all phases.
966799|NCT00908583|O1|Outcome|All Transplanted Participants|Combined phases, transplanted patients.
966800|NCT00908583|O1|Outcome|All Study Participants|All study participants combined.4 participants were enrolled in multiple groups or phases. They are only counted once.
966801|NCT00908583|O1|Outcome|All Study Participants|All study participants combined. Counting participants only once even though 7 participants were enrolled in multiple phases.
966802|NCT00908583|O8|Outcome|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
977368|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
966803|NCT00908583|O7|Outcome|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966804|NCT00908583|O6|Outcome|Phase 3, Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966805|NCT00908583|O5|Outcome|Phase 3, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966806|NCT00908583|O4|Outcome|Phase 2 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966807|NCT00908583|O3|Outcome|Phase 2, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966808|NCT00908583|O2|Outcome|Phase 1 Cycle 2|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966809|NCT00908583|O1|Outcome|Phase 1, Cycle 1|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966810|NCT00908583|E5|Reported Event|Phase 5, Single Stage|"Deletional, one stage approach with eight doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966811|NCT00908583|E4|Reported Event|Phase 4, Single Stage|"Deletional, one stage approach with six doses of plasmapheresis prior to each bortezomib dose~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966812|NCT00908583|E3|Reported Event|Phase 3|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
967123|NCT00907803|E1|Reported Event|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
966813|NCT00908583|E2|Reported Event|Phase 2, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966814|NCT00908583|E1|Reported Event|Phase 1, Two Stages|"Deletional, two stage approach with terminal plasmapheresis~Deletional therapy/plasmapheresis: B lymphocyte/plasma cell deletional therapy will be administered"
966815|NCT00908388|B1|Baseline|GORE Conformable TAG® Device Surgical Implant|Subjects prospectively treated with the GORE Conformable TAG® Thoracic Endoprosthesis for acute complicated type B aortic dissection
966816|NCT00908388|P1|Participant Flow|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
966817|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
966818|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
966819|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
966820|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
966821|NCT00908388|O1|Outcome|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
966822|NCT00908388|E1|Reported Event|GORE Conformable TAG® Device Surgical Implant|Subjects with acute complicated type B aortic dissection prospectively treated with endovascular surgery to implant the GORE ConformableTAG® Thoracic Endoprosthesis via femoral access. (permanent implant)
966823|NCT00908375|B3|Baseline|Total|Total of all reporting groups
966824|NCT00908375|B2|Baseline|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
966825|NCT00908375|B1|Baseline|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
966826|NCT00908375|P2|Participant Flow|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
966827|NCT00908375|P1|Participant Flow|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
966873|NCT00908128|B2|Baseline|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
977369|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
966828|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
966829|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
966830|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
966831|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
966884|NCT00908115|P1|Participant Flow|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
966832|NCT00908375|O2|Outcome|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
966833|NCT00908375|O1|Outcome|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
966834|NCT00908375|E2|Reported Event|Sugar Pill|"One Sugar pill capsule will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 Sugar pill capsules twice a day. The total duration of the treatment will be 3 weeks.~Sugar Pill: One sugar pill will be prescribed twice daily for the first week of the study. For the subsequent 2 weeks, 2 placebo(sugar pills) capsules twice a day. The total duration of the treatment will be 3 weeks."
966835|NCT00908375|E1|Reported Event|Pregabalin|"A 75mg pregabalin capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks.~Pregabalin: One pregabalin 75mg capsule will be prescribed twice daily for the first week of the study (150mg/day). For the subsequent 2 weeks, the dose will be increased to 2 pregabalin capsules twice a day (300mg/day). The total duration of the treatment will be 3 weeks."
966836|NCT00908349|B1|Baseline|Oxcarbazepine XR|"Open Label Study~Oxcarbazepine XR: Open Label Study"
966837|NCT00908349|P1|Participant Flow|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
966838|NCT00908349|O1|Outcome|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
966839|NCT00908349|E1|Reported Event|Oxcarbazepine XR|Oxcarbazepine XR: Open Label Study 600mg to 2400mg of SPN-804O once daily.
966840|NCT00908310|B1|Baseline|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
966841|NCT00908310|P1|Participant Flow|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
966842|NCT00908310|O1|Outcome|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
966843|NCT00908310|E1|Reported Event|Omniscan|OMNISCAN 287mg/mL will be administered intravenously at the medical discretion of the prescribing physician.
966844|NCT00908232|B1|Baseline|All Study Participants|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
966845|NCT00908232|P4|Participant Flow|SD: Bortezomib+Dexamethasone+Lenalidomide (VDR)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
966846|NCT00908232|P3|Participant Flow|SD: Bortezomib+Dexamethasone+Cyclophosphamide (VDC)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 and cyclophosphamide 500 mg, orally daily, days 1, 8 and 15 for cycle 5 to 8
966847|NCT00908232|P2|Participant Flow|Stable Disease: Bortezomib + Dexamethasone (VD)|Stable disease after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966848|NCT00908232|P1|Participant Flow|Cycle 1 to 4: Bortezomib + Dexamethasone (VD)|bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for 4 cycles
966849|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
977370|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
966850|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966851|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
966852|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966853|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
967124|NCT00907777|B3|Baseline|Total|Total of all reporting groups
966854|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966855|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
966856|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966857|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
966858|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966859|NCT00908232|O2|Outcome|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
966860|NCT00908232|O1|Outcome|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966861|NCT00908232|E2|Reported Event|Stable Disease After 4 Cycles: VD, VDC, VDL|Patients were treated with bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 1 to 4. Patients with stable disease after these 4 cycles, were randomized at the start of cycle 5 and received either bortezomib 1.3 mg/m2 IV bolus on day 1, 4, 8 and 11 in combination with dexamethasone 20 mg orally, on days 1, 2, 4, 5, 8, 9, 11, 12 alone or in combination with cyclophosphamide 500 mg orally on days 1, 8 and 15 or lenalidomide 10 mg orally daily from day 1 to day 14 for cycle 5 to 8
966862|NCT00908232|E1|Reported Event|Complete to Partial Response: Bortezomib + Dexamethasone|Complete, very good partial or partial response after 4 cycles bortezomib + dexamethasone: bortezomib 1.3 mg/m2 IV bolus on Day 1, 4, 8, 11 in combination with dexamethasone 20 mg orally daily, on Days 1, 2, 4, 5, 8, 9, 11, 12 for cycle 5 to 8
966863|NCT00908141|B3|Baseline|Total|Total of all reporting groups
966864|NCT00908141|B2|Baseline|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
966865|NCT00908141|B1|Baseline|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
966866|NCT00908141|P2|Participant Flow|Group B:Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
966867|NCT00908141|P1|Participant Flow|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
966868|NCT00908141|O2|Outcome|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
966869|NCT00908141|O1|Outcome|Group A: Sargramostim (Days 1-14)|"GROUP A:~Sargramostim 250ug/m2/day subcutaneously (s.c.) on days 1-14 of a 28-day cycle"
966870|NCT00908141|E2|Reported Event|Group B: Sargramostim (3 x Week)|"GROUP B:~Sargramostim 250ug subcutaneously (s.c.) three times a week continuously"
967703|NCT00905125|E2|Reported Event|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
966874|NCT00908128|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
966875|NCT00908128|P2|Participant Flow|CellCept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
966876|NCT00908128|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
966877|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
966878|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
966879|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
966880|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
966881|NCT00908128|O2|Outcome|CellCept®|CellCept® Tablets, 500 mg dosed in any period.
966882|NCT00908128|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period.
966883|NCT00908115|B1|Baseline|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
967296|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
970501|NCT00894790|B3|Baseline|Total|Total of all reporting groups
966885|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
966886|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
966887|NCT00908115|O1|Outcome|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
966888|NCT00908115|E1|Reported Event|Infanrix Group|Subjects received one dose of Infanrix™ at 2, 4 and 6 months of age (primary vaccination), one dose at 15-18 months of age (booster vaccination) and one dose at 4-6 years of age (booster vaccination).
966889|NCT00908076|B3|Baseline|Total|Total of all reporting groups
966890|NCT00908076|B2|Baseline|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966891|NCT00908076|B1|Baseline|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966892|NCT00908076|P2|Participant Flow|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966893|NCT00908076|P1|Participant Flow|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966894|NCT00908076|O2|Outcome|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966895|NCT00908076|O1|Outcome|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=39) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966896|NCT00908076|E2|Reported Event|Placebo|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966897|NCT00908076|E1|Reported Event|Amitiza|LUBIPROSTONE: Subjects will be randomized into placebo and study groups. Half of the study group (N=27) will be given lubiprostone (24 mcg) twice daily; the other half will receive matching placebo twice daily.
966898|NCT00908037|B8|Baseline|Total|Total of all reporting groups
966899|NCT00908037|B7|Baseline|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
966900|NCT00908037|B6|Baseline|Part 2 (Randomized Period) Cohort 3-Placebo|Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966911|NCT00908037|P7|Participant Flow|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
977371|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
966901|NCT00908037|B5|Baseline|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of &lt;27 kg received 25 mg QD and par with a weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD and par with a weight of &gt;=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
966902|NCT00908037|B4|Baseline|Part 2 (Randomized Period) Cohort 2-Placebo|Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of &lt;=27 kg received 25 mg QD and par with a body weight of &gt;=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
967297|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
970619|NCT00894465|B3|Baseline|Total|Total of all reporting groups
966903|NCT00908037|B3|Baseline|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
966904|NCT00908037|B2|Baseline|Part 2 (Randomized Period) Cohort 1-Placebo|Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
966905|NCT00908037|B1|Baseline|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
966906|NCT00908037|P12|Participant Flow|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966907|NCT00908037|P11|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966908|NCT00908037|P10|Participant Flow|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966909|NCT00908037|P9|Participant Flow|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966910|NCT00908037|P8|Participant Flow|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
966912|NCT00908037|P6|Participant Flow|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967280|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
966913|NCT00908037|P5|Participant Flow|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966914|NCT00908037|P4|Participant Flow|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966915|NCT00908037|P3|Participant Flow|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966916|NCT00908037|P2|Participant Flow|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966917|NCT00908037|P1|Participant Flow|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966918|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966919|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966920|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966921|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966922|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966923|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966924|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967107|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967108|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967109|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
977372|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
966925|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966926|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966927|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, as approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966928|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
966929|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966930|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966931|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose eltrombopag was 37.5 mg QD. The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966932|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966933|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966934|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966935|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966936|NCT00908037|O1|Outcome|Part 2/ 3 Eltrombopag Open-Label Period|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
966937|NCT00908037|O2|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
966938|NCT00908037|O1|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo QD for 7 weeks.
967110|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967704|NCT00905125|E1|Reported Event|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
966939|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of East Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
966940|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966941|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966942|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966943|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966944|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
966945|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966946|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966947|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966948|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966949|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966950|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966951|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967111|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967112|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967113|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
966952|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966966|NCT00908037|O2|Outcome|Part 2 Randomized Period - Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
967005|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
967192|NCT00907517|P4|Participant Flow|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
966953|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966954|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966955|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966956|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
966957|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966958|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966959|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966960|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966961|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966962|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966963|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966964|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
966978|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966965|NCT00908037|O3|Outcome|Part 2 Randomized Period - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
966967|NCT00908037|O1|Outcome|Part 1 Eltrombopag Dose-Finding Period|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
966968|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open- Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966969|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966970|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966971|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966972|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
966973|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966974|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966975|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966976|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966977|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966979|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966980|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
967286|NCT00907335|B1|Baseline|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
967287|NCT00907335|P2|Participant Flow|Vehicle Control|Color matched facial gel vehicle control used once daily
966981|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 7 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
966982|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
966983|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight <27 kg: 25 mg QD, Weight >=27 kg: 50 mg QD; east Asian ancestry subjects Weight <27 kg: 12.5 mg QD, Weight >=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
966984|NCT00908037|O4|Outcome|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
966985|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
966986|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
966987|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
966988|NCT00908037|O4|Outcome|Part 2/3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
966989|NCT00908037|O3|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
966990|NCT00908037|O2|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
967003|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967004|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967288|NCT00907335|P1|Participant Flow|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
966991|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period)|Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a body weight of <27 kg received 12.5 mg QD, par with a body weight of >=27 kg received 25 mg QD; par of east Asian ancestry with a body weight <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
966992|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the studyat 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966993|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966994|NCT00908037|O1|Outcome|Part 2/ 3 (Eltrombopag Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966995|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966996|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
966997|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
966998|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
966999|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967000|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967001|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967002|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967114|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967115|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967006|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967007|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967008|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967009|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967010|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967011|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967012|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967013|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967014|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967015|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967016|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967029|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967281|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
967047|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967289|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
972273|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
967017|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967018|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967019|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967020|NCT00908037|O2|Outcome|Part 1 (Dose-Finding Period) Cohort 2|Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of <27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of >=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967021|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967022|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967023|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of <=27 kg received 25 mg QD and participants with a body weight of >=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967024|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967025|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967026|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
967027|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967028|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967030|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967031|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967032|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967033|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967034|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967035|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967036|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967037|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967046|NCT00908037|O3|Outcome|Part 1 (Dose-Finding Period) Cohort 3|Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967116|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967117|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967118|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967038|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967039|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967040|NCT00908037|O3|Outcome|Eltrombopag Cohort 3 - 1-5 Years|Par aged between 1 and 5 years received eltrombopag administered as a dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par starting dose was 0.7mg/kg QD, par of East Asian ancestry began at 0.5mg/kg/day. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par starting dose was 1.5mg/kg QD, par of East Asian ancestry weighing began at 0.8 mg/kg/day. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967041|NCT00908037|O2|Outcome|Eltrombopag Cohort 2 - 6-11 Years|Par aged between 6 and 11 years received eltrombopag administered as a tablet or dry powder for oral suspension for a total of 24 weeks. Par in Part 1 received an OL trt based on body weight for 24 weeks. Par weighing <27 kilograms (kg) started at 12.5mg QD and par weighing >=27kg started at 25mg QD. Par randomized to eltrombopag in Part 2 received trt based on body weight for 7 weeks. Par weighing <27kg started at 25mg QD and par weighing >=27kg started at 50mg QD. Par of East Asian ancestry weighing <27kg began at 12.5mg QD and those >=27kg began at 25mg QD. Par who received 7 weeks of eltrombopag in Part 2 continued the same dose in Part 2/3 for an additional 17 weeks of trt to complete a total of 24 weeks. Par who received placebo in Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 using the same dosing guidelines as Part 2 up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967042|NCT00908037|O1|Outcome|Eltrombopag Cohort 1- 12-17 Years|Participants (par) aged between 12 and 17 years received eltrombopag administered as a tablet for a total of 24 weeks. Par in Part 1 received an Open-Label (OL) treatment (trt) starting at 25 milligrams (mg) once daily (QD) for 24 weeks. Par of East Asian ancestry began at 12.5mg QD. Par randomized to eltrombopag in Part 2 received eltrombopag for 7 weeks starting at 37.5mg QD. All par completing Part 2 received an OL trt of eltrombopag in Part 2/3. Par who received 7 weeks of eltrombopag in Part 2 received an additional 17 weeks of trt to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. Par who received placebo Part 2, received 24 weeks of trt of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75mg daily. All par underwent individual dose titration based upon platelet response.
967043|NCT00908037|O3|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 3|All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967044|NCT00908037|O2|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 2|All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of &lt;=27 kg received 25 mg QD and participants with a body weight of &gt;=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967045|NCT00908037|O1|Outcome|Part 2/3 (Eltrombopag Open-Label Period) Cohort 1|All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967102|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967103|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967048|NCT00908037|O1|Outcome|Part 1 (Dose-Finding Period) Cohort 1|Participants aged between 12 and 17 years received a 24-week Open-label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967049|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
967050|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
967051|NCT00908037|O2|Outcome|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of <27 kg received 25 mg QD, and par with a body weight of >=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD, and with a body weight of >=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
967052|NCT00908037|O1|Outcome|Part 2 (Randomized Period) -Placebo|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
967053|NCT00908037|O6|Outcome|Part 2 (Randomized Period) Cohort 3- Eltrombopag|Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967054|NCT00908037|O5|Outcome|Part 2 (Randomized Period) Cohort 3-Placebo|Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
967055|NCT00908037|O4|Outcome|Part 2 (Randomized Period) Cohort 2-Eltrombopag|Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of <27 kg received 25 mg QD and participants with a weight of >=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of <27 kg received 12.5 mg QD and participants with a weight of >=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967056|NCT00908037|O3|Outcome|Part 2 (Randomized Period) Cohort 2-Placebo|Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967057|NCT00908037|O2|Outcome|Part 2 (Randomized Period) Cohort 1- Eltrombopag|Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
967058|NCT00908037|O1|Outcome|Part 2 (Randomized Period) Cohort 1-Placebo|Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
967059|NCT00908037|E4|Reported Event|Part 2/ 3 (Eltrombopag Open-Label Period)|Par aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose unless adjustments were warranted according to the dosing guidelines. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
967060|NCT00908037|E3|Reported Event|Part 2 (Randomized Period) - Eltrombopag|Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of &lt;27 kg received 25 mg QD, and par with a body weight of &gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of &lt;27 kg received 12.5 mg QD, and with a body weight of &gt;=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
967061|NCT00908037|E2|Reported Event|Part 2 (Randomized Period) -Placebo|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3- 1 to 5 years) received eltrombopag matching placebo for 7 weeks.
967104|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967105|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967106|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967119|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967120|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967121|NCT00907803|E3|Reported Event|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967122|NCT00907803|E2|Reported Event|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967062|NCT00908037|E1|Reported Event|Part 1 (Dose-Finding Period)|Participants aged between 1 and 17 years (Cohort 1 age group- 12 to 17 years, Cohort 2- 6 to 11 years and Cohort 3-1 to 5 years) received eltrombopag for 24 weeks. The starting dose for cohort 1 was eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight &lt;27 kg: 25 mg QD, Weight &gt;=27 kg: 50 mg QD; east Asian ancestry subjects Weight &lt;27 kg: 12.5 mg QD, Weight &gt;=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
967063|NCT00908011|B3|Baseline|Total|Total of all reporting groups
967064|NCT00908011|B2|Baseline|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
967065|NCT00908011|B1|Baseline|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
967066|NCT00908011|P2|Participant Flow|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
967067|NCT00908011|P1|Participant Flow|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
967068|NCT00908011|O2|Outcome|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
967069|NCT00908011|O1|Outcome|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
967070|NCT00908011|E2|Reported Event|Standard Care|"Increased dose of rosuvastatin to 20mg/day~Rosuvastatin (standard care): Increased dose of rosuvastatin to 20mg/day"
967071|NCT00908011|E1|Reported Event|Ezetimibe|"10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)~Ezetimibe: 10mg/day ezetimibe in addition to ongoing rosuvastatin treatment (10mg/day)- tablet, orally, 10mg/day for 12 weeks"
967072|NCT00907907|B3|Baseline|Total|Total of all reporting groups
967073|NCT00907907|B2|Baseline|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
967074|NCT00907907|B1|Baseline|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
967075|NCT00907907|P2|Participant Flow|Cellcept® (Reference) First|CellCept® Tablets, 500 mg dosed in first period followed by Mycophenolate Mofetil Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
967076|NCT00907907|P1|Participant Flow|Mycophenolate Mofetil (Test) First|Mycophenolate Mofetil Tablets, 500 mg dosed in first period followed by CellCept® Tablets, 500 mg dosed in second period; sequence repeated in third and fourth periods.
967077|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
967078|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
967079|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
967080|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
967081|NCT00907907|O2|Outcome|Cellcept®|CellCept® Tablets, 500 mg dosed in any period
967082|NCT00907907|O1|Outcome|Mycophenolate Mofetil|Mycophenolate Mofetil Tablets, 500 mg dosed in any period
967083|NCT00907881|B1|Baseline|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
967084|NCT00907881|P1|Participant Flow|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
967085|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
967086|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
967087|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
967088|NCT00907881|O1|Outcome|All Participants|"Participants with type 2 diabetes mellitus (T2DM) who had sulfonylurea treatment added to an on-going regime of oral~hypoglycemic agent(s)."
967089|NCT00907881|E1|Reported Event|All Participants|
967090|NCT00907803|B4|Baseline|Total|Total of all reporting groups
967091|NCT00907803|B3|Baseline|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967092|NCT00907803|B2|Baseline|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967093|NCT00907803|B1|Baseline|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967094|NCT00907803|P3|Participant Flow|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967095|NCT00907803|P2|Participant Flow|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967096|NCT00907803|P1|Participant Flow|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967097|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967098|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967099|NCT00907803|O1|Outcome|ST-246 400 mg|400 mg ST-246 (2 x 200 mg capsules) given as a single daily oral dose to 45 subjects for 14 days.
967100|NCT00907803|O3|Outcome|Placebo|Matching Placebo capsules given as a single daily oral dose to 16 subjects for 14 days.
967101|NCT00907803|O2|Outcome|ST-246 600 mg|600 mg ST-246 (3 x 200 mg capsules) given as a single daily oral dose to 46 subjects for 14 days.
967125|NCT00907777|B2|Baseline|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967126|NCT00907777|B1|Baseline|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967127|NCT00907777|P2|Participant Flow|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967128|NCT00907777|P1|Participant Flow|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967129|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967130|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967131|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967132|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967133|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967134|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967135|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967136|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967137|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967138|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967139|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967173|NCT00907738|E1|Reported Event|Base Protocol 001 (Vorinostat 400 mg Once Daily [QD])|
967174|NCT00907621|B3|Baseline|Total|Total of all reporting groups
967786|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967140|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967141|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967142|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967143|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967144|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967145|NCT00907777|O2|Outcome|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967146|NCT00907777|O1|Outcome|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967147|NCT00907777|E2|Reported Event|GSK 1024850A Group|Subjects who were previously vaccinated with three primary doses of GSK 1024850A vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of GSK 1024850A vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967148|NCT00907777|E1|Reported Event|Prevnar Group|Subjects who were previously vaccinated with three primary doses of Prevnar™ vaccine in study 2005-003299-40 [10PN-PD-DIT-003 (105554)] and a booster dose of Pneumovax 23™ vaccine in study 2006-000560-93 [10PN-PD-DIT-008 BST: 003 (106623)], received one additional dose of Prevnar™ vaccine, administered intramuscularly in the deltoid, at approximately 4 years of age.
967149|NCT00907738|B6|Baseline|Total|Total of all reporting groups
967150|NCT00907738|B5|Baseline|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
967151|NCT00907738|B4|Baseline|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
967152|NCT00907738|B3|Baseline|Base Protocol 008|vorinostat 400 mg QD
967153|NCT00907738|B2|Baseline|Base Protocol 006|vorinostat 200 mg twice daily (BID)
967154|NCT00907738|B1|Baseline|Base Protocol 001|Vorinostat 400 mg daily (QD)
967155|NCT00907738|P5|Participant Flow|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
967156|NCT00907738|P4|Participant Flow|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
967157|NCT00907738|P3|Participant Flow|Base Protocol 008|vorinostat 400 mg QD
967158|NCT00907738|P2|Participant Flow|Base Protocol 006|vorinostat 200 mg twice daily (BID)
967159|NCT00907738|P1|Participant Flow|Base Protocol 001|Vorinostat 400 mg daily (QD)
967160|NCT00907738|O5|Outcome|Base Protocol 013|vorinostat 200 mg BID 14/21 OR 300 mg BID 3/7 (3 days dosing followed by 4 days rest every week)
967161|NCT00907738|O4|Outcome|Base Protocol 012|400 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel & cisplatin OR 300 mg BID 3/7 (3 days of dosing followed by 7 days rest every first week followed by 2 weeks off) OR 300 mg QD 14/21 (14 days of dosing followed by 7 days rest every 21 day cycle) OR 300 mg QD 7/21 (7 days of dosing followed by 14 days rest every 21 day cycle) + pemetrexel
967162|NCT00907738|O3|Outcome|Base Protocol 008|vorinostat 400 mg QD
967163|NCT00907738|O2|Outcome|Base Protocol 006|vorinostat 200 mg twice daily (BID)
967164|NCT00907738|O1|Outcome|Base Protocol 001|Vorinostat 400 mg daily (QD)
967165|NCT00907738|E9|Reported Event|Base Protocol 013 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
967166|NCT00907738|E8|Reported Event|Base Protocol 013 (Vorinostat 200 mg Twice Daily [BID] 14/21)|
967167|NCT00907738|E7|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 7/21)|
967168|NCT00907738|E6|Reported Event|Base Protocol 012 (Vorinostat 300 mg Once Daily [QD] 14/21)|
967169|NCT00907738|E5|Reported Event|Base Protocol 012 (Vorinostat 300 mg Twice Daily [BID] 3/7)|
967170|NCT00907738|E4|Reported Event|Base Protocol 012 (Vorinostat 400 mg Once Daily [QD] 7/21)|
967171|NCT00907738|E3|Reported Event|Base Protocol 008 (Vorinostat 400 mg Once Daily [QD])|
967172|NCT00907738|E2|Reported Event|Base Protocol 006 (Vorinostat 200 mg Twice Daily [BID])|
967175|NCT00907621|B2|Baseline|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
967290|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
967291|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
967176|NCT00907621|B1|Baseline|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36.~The baseline characteristics of age and gender are based on the 84 collected interviews, while the crying time baseline units are based on the 79 collected crying time diaries. This is why numbers differ from the Participant Flow module. Only 79 participants were analyzed for crying time."
967177|NCT00907621|P2|Participant Flow|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
967178|NCT00907621|P1|Participant Flow|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
967179|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
967180|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
967181|NCT00907621|O2|Outcome|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
967182|NCT00907621|O1|Outcome|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
967183|NCT00907621|E2|Reported Event|Control|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~The Control group will have no intervention."
967184|NCT00907621|E1|Reported Event|Acupuncture|"Infants born after 36th week of gestation and weighing over 2500 grams at birth, and who qualify according to Wessels definition:~Paroxystical, uncontrolled crying in an otherwise healthy child under 3 months of age, and with more than 3 hours of crying 3 days per week for 3 weeks.~Acupuncture with Seirin 020x15 mm sterile acupuncture needle : Bilateral insertion of a Seirin 020x15mm sterile acupuncture needle to a depth of 12mm for 30 seconds during 3 consecutive working days at the WHO designated acupuncture point St36."
967185|NCT00907517|B6|Baseline|Total|Total of all reporting groups
967186|NCT00907517|B5|Baseline|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967187|NCT00907517|B4|Baseline|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967188|NCT00907517|B3|Baseline|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967189|NCT00907517|B2|Baseline|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967190|NCT00907517|B1|Baseline|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967248|NCT00907478|E1|Reported Event|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967249|NCT00907426|B4|Baseline|Total|Total of all reporting groups
977373|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
967191|NCT00907517|P5|Participant Flow|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967292|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
967293|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
967193|NCT00907517|P3|Participant Flow|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967194|NCT00907517|P2|Participant Flow|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967195|NCT00907517|P1|Participant Flow|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 intravenously (IV) on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour continuous intravenous infusion (CIV) on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967196|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967197|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967198|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967199|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967200|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967201|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967202|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967203|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967204|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967205|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967206|NCT00907517|O5|Outcome|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967207|NCT00907517|O4|Outcome|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967208|NCT00907517|O3|Outcome|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967209|NCT00907517|O2|Outcome|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967278|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
967210|NCT00907517|O1|Outcome|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967211|NCT00907517|E5|Reported Event|MK-8776 140 mg + Cytarabine 2 g/m^2|Participants received MK-8776 140 mg flat dose IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
973294|NCT00886639|B1|Baseline|6MWT With Different Gas Mixtures|
967212|NCT00907517|E4|Reported Event|MK-8776 56 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 56 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967213|NCT00907517|E3|Reported Event|MK-8776 40 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 40 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967214|NCT00907517|E2|Reported Event|MK-8776 20 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 20 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967215|NCT00907517|E1|Reported Event|MK-8776 10 mg/m^2 + Cytarabine 2 g/m^2|Participants received MK-8776 10 mg/m^2 IV on Days 2 and 3 and again on Days 11 and 12 PLUS cytarabine 2 g/m^2 IV via 72-hour CIV on Days 1 through 3 and repeated on Days 10 through 12 of a treatment cycle. The duration of one treatment cycle was to be approximately 4 to 6 weeks (until hospital discharge).
967216|NCT00907478|B4|Baseline|Total|Total of all reporting groups
967217|NCT00907478|B3|Baseline|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967218|NCT00907478|B2|Baseline|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967219|NCT00907478|B1|Baseline|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967220|NCT00907478|P3|Participant Flow|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967221|NCT00907478|P2|Participant Flow|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967222|NCT00907478|P1|Participant Flow|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967223|NCT00907478|O1|Outcome|Romiplostim|Participants received once weekly romiplostim for 3 years.
967224|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967225|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967226|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967227|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967228|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967229|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967230|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967231|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967232|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967233|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967234|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967235|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967236|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967237|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967238|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967239|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967240|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967241|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967242|NCT00907478|O3|Outcome|Cohort 3|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967243|NCT00907478|O2|Outcome|Cohort 2|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967244|NCT00907478|O1|Outcome|Cohort 1|Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 1.
967245|NCT00907478|E4|Reported Event|Overall|Participants received once weekly romiplostim for 3 years.
967246|NCT00907478|E3|Reported Event|Cohort 3|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 3.
967247|NCT00907478|E2|Reported Event|Cohort 2|Year 1 Participants received once weekly romiplostim for 3 years and had a bone marrow biopsy at Baseline and Year 2.
967250|NCT00907426|B3|Baseline|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967294|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
967295|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
973295|NCT00886639|P1|Participant Flow|6MWT With Different Gas Mixtures|
967251|NCT00907426|B2|Baseline|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967252|NCT00907426|B1|Baseline|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967253|NCT00907426|P3|Participant Flow|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967254|NCT00907426|P2|Participant Flow|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967255|NCT00907426|P1|Participant Flow|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967256|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967257|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967258|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967259|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967260|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967261|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967262|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967263|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967264|NCT00907426|O2|Outcome|Vehicle|Once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967265|NCT00907426|O1|Outcome|Bimatoprost 0.03%|Once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin).
967266|NCT00907426|E3|Reported Event|Vehicle Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967267|NCT00907426|E2|Reported Event|Bimatoprost 0.03% Followed by Vehicle|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of vehicle solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967268|NCT00907426|E1|Reported Event|Bimatoprost 0.03% Followed by Bimatoprost 0.03%|Treatment period one (0-6 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin (where the eyelashes meet the skin). For treatment period two (6-12 months), once daily, one drop of Bimatoprost 0.03% solution using a single-use per eye applicator will be applied to the upper eyelid margin.
967269|NCT00907374|B3|Baseline|Total|Total of all reporting groups
967270|NCT00907374|B2|Baseline|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
967271|NCT00907374|B1|Baseline|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
967272|NCT00907374|P2|Participant Flow|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
967273|NCT00907374|P1|Participant Flow|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
967274|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
967275|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
967276|NCT00907374|O2|Outcome|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
967277|NCT00907374|O1|Outcome|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
967282|NCT00907374|E2|Reported Event|Agressive Inhibition of the RAS|40-80 mg benazepril plus 25-100 mg losartan both p.o. 1-2X per day
967283|NCT00907374|E1|Reported Event|Low Dose Inhibition of RAS|10 mg benazepril plus other anti-hypertensive agents to treat elevated BP
967284|NCT00907335|B3|Baseline|Total|Total of all reporting groups
967285|NCT00907335|B2|Baseline|Vehicle Control|Color matched facial gel vehicle control used once daily
967298|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
967299|NCT00907335|O2|Outcome|Vehicle Control|Color matched facial gel vehicle control used once daily
967300|NCT00907335|O1|Outcome|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
967301|NCT00907335|E2|Reported Event|Vehicle Control|Color matched facial gel vehicle control used once daily
967302|NCT00907335|E1|Reported Event|Retin-A Micro|Retin-A Micro 0.04% facial acne treatment used once daily
967303|NCT00907257|B3|Baseline|Total|Total of all reporting groups
967304|NCT00907257|B2|Baseline|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
967305|NCT00907257|B1|Baseline|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
967306|NCT00907257|P2|Participant Flow|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
967307|NCT00907257|P1|Participant Flow|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
967308|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
967309|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
967310|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
967311|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
967312|NCT00907257|O2|Outcome|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
967313|NCT00907257|O1|Outcome|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
967314|NCT00907257|E2|Reported Event|Different Times of Day|5% benzoyl peroxide wash used in the morning and 0.04% tretinoin gel used in the evening
967315|NCT00907257|E1|Reported Event|Same Time of Day|5% benzoyl peroxide wash and 0.04% tretinoin gel used at same time of day
967316|NCT00907218|B1|Baseline|No Data Was Analyzed|
967317|NCT00907218|P1|Participant Flow|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
967318|NCT00907218|O1|Outcome|Adults Who Meet DSM-IV-TR Criteria for ADHD and Smoke Cigarett|
967319|NCT00907218|E1|Reported Event|Adults Who Meet DSM-IV-TR Criteria for Attention Deficit Hyper|Varenicline (Chantix) : Upon completion of screening procedures and meeting eligibility criteria, subjects will begin taking varenicline daily until Week 6 of the study. At Week 6 they will discontinue varenicline and return one week later for their final study visit to assess return of ADHD symptomatology. Subjects will start on 0.5 mg of varenicline per day for the first week of treatment. The dose will be increased to 0.5 mg twice a day at the end of week 1 visit, and then increased to 1 mg twice a day at the end of week 2 visit, to remain at this dose until the week 6 visit. At week 6, all subjects will be openly discontinued from varenicline, to return to the office the following week for re-assessment one week off the medication. If significant adverse effects (AE) occur, the daily dose may be reduced by 0.5 to 1 mg. At subsequent visits, a higher dose may be resumed if
967320|NCT00907101|B1|Baseline|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967321|NCT00907101|P1|Participant Flow|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967322|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967323|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967324|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967325|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967326|NCT00907101|O1|Outcome|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967327|NCT00907101|E1|Reported Event|Epiduo® Gel|Adapalene 0.1%/Benzoyl Peroxide 2.5% Gel (Epiduo® Gel Applied Once Daily
967328|NCT00907088|B3|Baseline|Total|Total of all reporting groups
967329|NCT00907088|B2|Baseline|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling provided in the control group, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
967330|NCT00907088|B1|Baseline|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel based on the Canadian Paediatric Society Guidelines. Nutrition counselling occurs at the 9-month visit and is repeated at the 15-month visit if the child has not transitioned into the use of a cup. Recommendations include iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
967331|NCT00907088|P2|Participant Flow|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
967332|NCT00907088|P1|Participant Flow|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
968127|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
967333|NCT00907088|O2|Outcome|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
967334|NCT00907088|O1|Outcome|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
967335|NCT00907088|E2|Reported Event|Intervention Group|Healthy milk intake: In addition to the standard nutrition counselling, the intervention group will receive specific information regarding healthy milk intake (2 cups per day, maximum 16 ounces) and the potential negative health effects of prolonged bottle use and excessive milk intake including anemia, iron depletion, and dental carries.
967336|NCT00907088|E1|Reported Event|Control Group|Standard nutrition counselling: Parents of children will receive nutrition counselling via trained study personnel, including recommendations for iron containing food choices and timing of cow's milk introduction. This group will also receive a colourful nutrition book.
967337|NCT00906971|B3|Baseline|Total|Total of all reporting groups
967338|NCT00906971|B2|Baseline|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
967339|NCT00906971|B1|Baseline|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
967340|NCT00906971|P2|Participant Flow|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
967341|NCT00906971|P1|Participant Flow|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
967342|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
967343|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
967344|NCT00906971|O2|Outcome|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
967345|NCT00906971|O1|Outcome|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
967346|NCT00906971|E2|Reported Event|Physiotherapy + Medication|Physiotherapy exercises were conducted by one single generalist physiotherapist, specially trained to perform the exercises during the three months prior to the study. Twelve individual sessions were held twice a week, each lasting forty minutes, and adherence was confirmed only if patients attended all twelve sessions. A one-minute rest period was observed between each series of exercises.
967347|NCT00906971|E1|Reported Event|Medication|Magnesium hydroxide for which the dosage varied according to individual needs (a minimum of 2 ml/kg), and received guidance regarding fiber-rich foods, water and toilet training. Patients attended weekly consultations with a pediatric gastroenterologist.
967348|NCT00906945|B6|Baseline|Total|Total of all reporting groups
967528|NCT00906399|P5|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
967349|NCT00906945|B5|Baseline|Dose Level 5 (Includes MTD-Phase II)|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967350|NCT00906945|B4|Baseline|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967351|NCT00906945|B3|Baseline|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967352|NCT00906945|B2|Baseline|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967353|NCT00906945|B1|Baseline|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967536|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967933|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
967354|NCT00906945|P6|Participant Flow|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8~Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967355|NCT00906945|P5|Participant Flow|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967356|NCT00906945|P4|Participant Flow|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967357|NCT00906945|P3|Participant Flow|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967358|NCT00906945|P2|Participant Flow|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967359|NCT00906945|P1|Participant Flow|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967360|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967361|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967362|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967363|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967364|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967365|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967366|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967367|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967368|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967369|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967370|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967371|NCT00906945|O1|Outcome|Phase I and Phase II Participants|
967372|NCT00906945|O5|Outcome|Grade 5|
967373|NCT00906945|O4|Outcome|Grade 4|
967374|NCT00906945|O3|Outcome|Grade 3|
967375|NCT00906945|O2|Outcome|Grade 2|
967376|NCT00906945|O1|Outcome|Grade 1|
967377|NCT00906945|O1|Outcome|Phase II (MTD)|
967378|NCT00906945|O1|Outcome|Phase I (Includes Levels 1-5)|
967379|NCT00906945|E6|Reported Event|MTD - Phase II|"G-CSF MTD determined in Phase 1 SQ on Days 1-8~Plerixafor MTD determined in Phase 1 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967380|NCT00906945|E5|Reported Event|Dose Level 5|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 750 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967381|NCT00906945|E4|Reported Event|Dose Level 4|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 560 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967382|NCT00906945|E3|Reported Event|Dose Level 3|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 420 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967383|NCT00906945|E2|Reported Event|Dose Level 2|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 320 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967384|NCT00906945|E1|Reported Event|Dose Level 1|"G-CSF 10 mcg/kg SQ on Days 1-8~Plerixafor 240 mcg/kg/d IV qd~Mitoxantrone 8 mg/m2/day IV once over 30 minutes daily on days 4-8~Etoposide 100 mg/m2/day IV once over 60 minutes daily on days 4-8~Cytarabine 1000 mg/m2/day IV once over 60 minutes daily on days 4-8"
967385|NCT00906789|B1|Baseline|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard CAD Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, both SoftView (TM) OnGuard (TM) CADe Software with be tested"
967696|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967386|NCT00906789|P1|Participant Flow|Radiologists|"Radiologists who have certification by the American Board of Radiology~Riverain OnGuard and SoftView Software : This is an observer performance study. Radiologists will interpret chest radiographs without and then with the Riverain software, Two types of software are tested: SoftView (TM). SoftView decreases the visibility of the ribs and clavicles on chest radiographs. OnGuard marks locations on chest radiographs meeting some of the software signs of lung nodules, a method often called Computer Aided Detection (CADe)."
967387|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
967388|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
967423|NCT00906698|P2|Participant Flow|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967934|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
967389|NCT00906789|O1|Outcome|Radiologists Using OnGuard Software: Difference of 1.0 and 5.1|Radiologists using OnGuard software. Two different versions were tested. OnGuard 1.0 and OnGuard 5.1. This software uses a computer algorithm to identify non-calcified lung nodules consistent with lung cancer. The value presented is the average difference in the areas under the LROC curve as demonstrated for the participating radiologists. The value for OnGuard 5.1 was subtracted from that of OnGuard 1.0, so a negative value indicates that OnGuard 5.1 had a higher value than OnGuard 1.0. The 95% confidence interval indicates that the OnGuard 5.1 was significantly improved.
967390|NCT00906789|O2|Outcome|Radiologists Using Softview Software|This software suppresses the visibility of the ribs and clavicles potentially revealing non-calcified nodules make less conspicuous by the bones projected on top of the nodules
967391|NCT00906789|O1|Outcome|Radiologists Control for SoftView|Control image interpretation unaided by software of either type. This is the control for the SoftView experiment. It uses the same radiologists (to avoid a bias that might result from using different radiologists) as the OnGuard Computer-aided detection software, but different cases.
967392|NCT00906789|E1|Reported Event|Participants|The 15 radiologists who participated
967393|NCT00906776|B3|Baseline|Total|Total of all reporting groups
967394|NCT00906776|B2|Baseline|Autogenous Bone|Autogenous bone from the patient
967395|NCT00906776|B1|Baseline|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967396|NCT00906776|P2|Participant Flow|Autogenous Bone|Autogenous bone from the patient
967397|NCT00906776|P1|Participant Flow|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967398|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
967399|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967400|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
967401|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967402|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
967403|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967404|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
967405|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967406|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
967407|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967408|NCT00906776|O2|Outcome|Autogenous Bone|Autogenous bone from the patient
967409|NCT00906776|O1|Outcome|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967410|NCT00906776|E2|Reported Event|Autogenous Bone|Autogenous bone from the patient
967411|NCT00906776|E1|Reported Event|Emdogain PLUS|Straumann Emdogain in combination with Straumann BoneCeramic
967412|NCT00906698|B7|Baseline|Total|Total of all reporting groups
967413|NCT00906698|B6|Baseline|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967414|NCT00906698|B5|Baseline|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967415|NCT00906698|B4|Baseline|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967416|NCT00906698|B3|Baseline|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967417|NCT00906698|B2|Baseline|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967418|NCT00906698|B1|Baseline|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967419|NCT00906698|P6|Participant Flow|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967527|NCT00906399|P6|Participant Flow|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967420|NCT00906698|P5|Participant Flow|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967421|NCT00906698|P4|Participant Flow|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
967422|NCT00906698|P3|Participant Flow|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
968128|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
967424|NCT00906698|P1|Participant Flow|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity
967425|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
967426|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
967427|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os
967428|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os
967429|NCT00906698|O2|Outcome|in Absence of Afatinib|60mg/m^2 vinorelbine per os in absence of afatinib
967430|NCT00906698|O1|Outcome|in Presence of Afatinib|60mg/m^2 vinorelbine per os in presence of afatinib
967431|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine per os
967432|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine per os
967433|NCT00906698|O2|Outcome|in Absence of Afatinib|60 mg/m^2 vinorelbine per os in absence of Afatinib
967434|NCT00906698|O1|Outcome|in Presence of Afatinib|60 mg/m^2 vinorelbine per os in presence of Afatinib
967435|NCT00906698|O2|Outcome|in Absence of Vinorelbine Per os|Afatinib 40 mg in absence of 60mg/m^2 vinorelbine per os.
967436|NCT00906698|O1|Outcome|in Presence of Vinorelbine Per os|Afatinib 40 mg in presence of 60mg/m^2 vinorelbine per os.
967437|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
967438|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
967439|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
967440|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
967441|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 and 50mg Afatinib
967442|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50mg Afatinib
967443|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
967444|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
967445|NCT00906698|O2|Outcome|in Absence of Afatinib|25mg/m^2 vinorelbine i.v. in absence of Afatinib 20, 40 or 50 mg
967446|NCT00906698|O1|Outcome|in Presence of Afatinib|25mg/m^2 vinorelbine i.v. in presence of Afatinib 20, 40 and 50 mg
967447|NCT00906698|O2|Outcome|in Absence of Vinorelbine i.v.|Afatinib 40 mg in absence of 25mg/m^2 vinorelbine i.v.
967448|NCT00906698|O1|Outcome|in Presence of Vinorelbine i.v.|Afatinib 40 mg in presence of 25mg/m^2 vinorelbine i.v.
967449|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967450|NCT00906698|O1|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967451|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967452|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967453|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967454|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967455|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
977374|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
967456|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967457|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967458|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967459|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967460|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967461|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967462|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967463|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967464|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967465|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967466|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967467|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967468|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967469|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967470|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967471|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967472|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967473|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967474|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967475|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967476|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967697|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967477|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967478|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967479|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967480|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
982853|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
967481|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967482|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967483|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967484|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967485|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967486|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967487|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967488|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967489|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967490|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967491|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967492|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967493|NCT00906698|O6|Outcome|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967494|NCT00906698|O5|Outcome|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967495|NCT00906698|O4|Outcome|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967496|NCT00906698|O3|Outcome|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967497|NCT00906698|O2|Outcome|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967698|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967498|NCT00906698|O1|Outcome|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity.
967499|NCT00906698|E6|Reported Event|Afatinib 50mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 50mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
967500|NCT00906698|E5|Reported Event|Afatinib 40mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 40mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
967501|NCT00906698|E4|Reported Event|Afatinib 20mg With Vinorelbine Per os|Continuous daily dosing of Afatinib 20mg orally and oral vinorelbine 60 mg/m2/week for days 1,8,15 of first cycle, and 80mg/m2 from day 22 first cycle onwards, weekly. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
967502|NCT00906698|E3|Reported Event|Afatinib 50mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 50mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
967503|NCT00906698|E2|Reported Event|Afatinib 40mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 40mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
967504|NCT00906698|E1|Reported Event|Afatinib 20mg With Vinorelbine i.v.|Continuous daily dosing of Afatinib 20mg orally and weekly Vinorelbine 25 mg/m2 intravenously (days 1, 8, 15 and 22) in a 4-weekly course. Patients will be eligible for repeated treatment courses in the absence of clinical disease progression or undue toxicity .
967505|NCT00906503|B1|Baseline|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
967506|NCT00906503|P1|Participant Flow|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
967507|NCT00906503|O1|Outcome|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
967508|NCT00906503|E1|Reported Event|PET/Computed Tomography (CT)|"Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan; Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~dexamethasone: Four 4 mg dexamethasone tablets by mouth after food 40, 28, 16 and 4 hrs before the scan~PET/Computed Tomography (CT): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs~fludeoxyglucose (18F): Radioactive tracer (18F-FDG), approx. 1 ml (1/5 of a tsp.); Scanned for about 15 minutes for imaging the lungs"
967509|NCT00906425|B3|Baseline|Total|Total of all reporting groups
967510|NCT00906425|B2|Baseline|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
967511|NCT00906425|B1|Baseline|Submerged Healing|The dental implants will be placed using a submerged healing treatment
967512|NCT00906425|P2|Participant Flow|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
967513|NCT00906425|P1|Participant Flow|Submerged Healing|The dental implants will be placed using a submerged healing treatment
967514|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
967515|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
967516|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
967517|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
967518|NCT00906425|O2|Outcome|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
967519|NCT00906425|O1|Outcome|Submerged Healing|The dental implants will be placed using a submerged healing treatment
967520|NCT00906425|E2|Reported Event|Trans-mucosal Healing|The dental implants will be placed using a trans-mucosal healing treatment
967521|NCT00906425|E1|Reported Event|Submerged Healing|The dental implants will be placed using a submerged healing treatment
967522|NCT00906399|B4|Baseline|Total|Total of all reporting groups
967523|NCT00906399|B3|Baseline|Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks
967524|NCT00906399|B2|Baseline|Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967525|NCT00906399|B1|Baseline|Placebo|Placebo every 2 weeks for 48 weeks
967526|NCT00906399|P7|Participant Flow|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967529|NCT00906399|P4|Participant Flow|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967530|NCT00906399|P3|Participant Flow|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967531|NCT00906399|P2|Participant Flow|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967532|NCT00906399|P1|Participant Flow|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
967533|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967534|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967535|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
967537|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967538|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
967539|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967540|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967541|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
967542|NCT00906399|O3|Outcome|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967543|NCT00906399|O2|Outcome|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967544|NCT00906399|O1|Outcome|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
967545|NCT00906399|E7|Reported Event|Year 2: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967546|NCT00906399|E6|Reported Event|Year 2: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967547|NCT00906399|E5|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q2W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 2 weeks for 48 weeks.
967548|NCT00906399|E4|Reported Event|Year 2: Placebo Followed by Peginterferon Beta-1a Q4W|Placebo every 2 weeks for 48 weeks followed by 125 µg peginterferon beta-1a subcutaneously every 4 weeks for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967549|NCT00906399|E3|Reported Event|Year 1: Peginterferon Beta-1a Q2W|125 µg peginterferon beta-1a subcutaneously every 2 weeks (Q2W) for 48 weeks.
967550|NCT00906399|E2|Reported Event|Year 1: Peginterferon Beta-1a Q4W|125 µg peginterferon beta-1a subcutaneously every 4 weeks (Q4W) for 48 weeks. Participants received a placebo injection 2 weeks after each active injection (in order to maintain the blind with Q2W arm).
967551|NCT00906399|E1|Reported Event|Year 1: Placebo|Placebo every 2 weeks for 48 weeks
967552|NCT00906347|B3|Baseline|Total|Total of all reporting groups
967553|NCT00906347|B2|Baseline|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967554|NCT00906347|B1|Baseline|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967555|NCT00906347|P2|Participant Flow|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967556|NCT00906347|P1|Participant Flow|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967557|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967558|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967559|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967560|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967561|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967562|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967563|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967564|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967565|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967566|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967567|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967935|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
967568|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967569|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967570|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967571|NCT00906347|O2|Outcome|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967572|NCT00906347|O1|Outcome|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967573|NCT00906347|E2|Reported Event|Oxytocin Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive intravenous oxytocin.~Oxytocin : Intravenous oxytocin will be administered per the established Labor and Delivery protocol at Parkland Memorial Hospital"
967574|NCT00906347|E1|Reported Event|Misoprostol Augmentation|"Women with hypotonic labor and a clinical decision to proceed with labor augmentation will receive oral misoprostol.~Misoprostol : 75 micrograms orally every 4 hours for up to 2 doses."
967575|NCT00906282|B1|Baseline|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment given on Day 1 of each 21-day cycle:~Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes~Carboplatin: AUC 6.0, IV infused over 30-60 minutes~At weeks 15-18, surgical candidates will have resection."
967576|NCT00906282|P1|Participant Flow|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
967577|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks (4 cycles) of preoperative treatment on Day 1 of each 21-day cycle:~Pemetrexed: 500 mg/m2 intravenously (IV) over 10 minutes~Carboplatin: AUC 6.0, IV infused over 30-60 minutes~At weeks 15-18, surgical candidates will have resection."
967578|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
967579|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
967580|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
967581|NCT00906282|O1|Outcome|Pemetrexed/Carboplatin/Surgery|"Up to 12 weeks of preoperative chemotherapy:~Pemetrexed: 500 mg/m2 intravenously (IV) for 10 minutes on Day 1 each cycle;~Carboplatin: AUC 6.0 by IV over 30-60 minutes on Day 1 each cycle~Weeks 15-18: Patients deemed surgical candidates will have resection."
967582|NCT00906282|E1|Reported Event|Pemetrexed/Carboplatin|All patients who received at least 1 dose of study treatment were included in the safety analysis.
967583|NCT00906243|B1|Baseline|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
967584|NCT00906243|P1|Participant Flow|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
967585|NCT00906243|O1|Outcome|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
967586|NCT00906243|E1|Reported Event|CV9103|CV9103 will be applied intradermally on three (3) or five (5) time points. Treatment with CV9103 is administered over a period of either seven (7) or twenty-three (23) weeks.
967587|NCT00906204|B3|Baseline|Total|Total of all reporting groups
967588|NCT00906204|B2|Baseline|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967589|NCT00906204|B1|Baseline|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967590|NCT00906204|P2|Participant Flow|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967591|NCT00906204|P1|Participant Flow|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967592|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967593|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
968129|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
967594|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967595|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967596|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967597|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967598|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967599|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967600|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967601|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967602|NCT00906204|O2|Outcome|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967603|NCT00906204|O1|Outcome|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967604|NCT00906204|E2|Reported Event|Divided-dose Thymoglobulin|"Biological/Vaccine Divided-dose rabbit Anti-thymocyte Globulin induction, 1.5 mg/kg IV infusion QD x 4~Divided-dose rabbit Anti-thymocyte Globulin induction: 6 mg/kg total rabbit Anti-thymocyte Globulin dose administered as 1.5 mg/kg doses on 4 sequential days, beginning on the day of kidney transplantation."
967605|NCT00906204|E1|Reported Event|Single-dose Thymoglobulin|"Biological/Vaccine Single-dose rabbit Anti-thymocyte Globulin induction, 6 mg/kg IV infusion~Single-dose rabbit Anti-thymocyte Globulin induction: 6 mg of rATG administered in a single dose on the day of kidney transplantation"
967606|NCT00906178|B3|Baseline|Total|Total of all reporting groups
967607|NCT00906178|B2|Baseline|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
967608|NCT00906178|B1|Baseline|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
967609|NCT00906178|P2|Participant Flow|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
967610|NCT00906178|P1|Participant Flow|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
967611|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
967612|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
967613|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
967614|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
967615|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
967616|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
967699|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967617|NCT00906178|O2|Outcome|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
967618|NCT00906178|O1|Outcome|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
967619|NCT00906178|E2|Reported Event|Control|"treatment as usual - the sexual health education adolescents currently receive in secondary school~CybereSenga: Internet-based HIV prevention program"
967620|NCT00906178|E1|Reported Event|HIV Prevention|"6-module HIV prevention program tailored for adolescents in Uganda~CybereSenga: Internet-based HIV prevention program"
967621|NCT00906087|B1|Baseline|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
967622|NCT00906087|P1|Participant Flow|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
967793|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967623|NCT00906087|O1|Outcome|Cosopt|"Intraocular pressure and blood pressure measurements will be compared under the following conditions: 1) after washout of clinical treatment, 2) after treatment with Cosopt, and 3) after another washout of Cosopt.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
967624|NCT00906087|O1|Outcome|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
967625|NCT00906087|O1|Outcome|Cosopt|"Intraocular pressure comparison after washout of Cosopt and while on treatment with Cosopt~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
967626|NCT00906087|E2|Reported Event|Washout (no Glaucoma Medication)|After appropriate washout, no glaucoma medication was administered for 6 weeks.
967627|NCT00906087|E1|Reported Event|Cosopt|"Cosopt 1 drop two times daily was administered for 6 weeks.~Cosopt (combination eyedrop of dorzolamide and timolol): One drop in each eye every twelve hours for six weeks"
967628|NCT00906074|B3|Baseline|Total|Total of all reporting groups
967629|NCT00906074|B2|Baseline|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967630|NCT00906074|B1|Baseline|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967631|NCT00906074|P2|Participant Flow|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967632|NCT00906074|P1|Participant Flow|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967633|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967634|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967635|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967636|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967637|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967638|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967639|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967640|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967641|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967642|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967643|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967644|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967645|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967700|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967646|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967647|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967648|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967649|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967794|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967650|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967651|NCT00906074|O2|Outcome|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967652|NCT00906074|O1|Outcome|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967653|NCT00906074|E2|Reported Event|Control|Participants who were free of surgical site infection (SSI) within 30 days following surgeon matched elective or emergency abdominal surgery.
967654|NCT00906074|E1|Reported Event|Case|Cases were defined as participants with severe surgical site infection (SSI) (deep incisional or organ space type; see Center for Disease Control [CDC] criteria for definition in the Appendix) in participants who underwent elective or emergency abdominal surgery in the previous 30 days.
967655|NCT00905164|B3|Baseline|Total|Total of all reporting groups
967656|NCT00905164|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules,2 x 25 mg (test) dosed in second period
967657|NCT00905164|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
967658|NCT00905164|P2|Participant Flow|Topomax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
967659|NCT00905164|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topomax® Capsules, 2 x 25 mg (reference) dosed in second period
967660|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
967661|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
967662|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
967663|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
967664|NCT00905164|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
967665|NCT00905164|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
967666|NCT00905151|B1|Baseline|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
967667|NCT00905151|P1|Participant Flow|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
967668|NCT00905151|O1|Outcome|HIV Positive|Across-sectional analysis of 200 HIV+ patients with varying levels of kidney function
967669|NCT00905151|E1|Reported Event|HIV Positive|A cross-sectional analysis of 200 HIV+ patients with varying levels of kidney function
967670|NCT00905125|B3|Baseline|Total|Total of all reporting groups
967671|NCT00905125|B2|Baseline|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967672|NCT00905125|B1|Baseline|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967673|NCT00905125|P2|Participant Flow|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967674|NCT00905125|P1|Participant Flow|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967675|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967676|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967677|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967678|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967679|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967680|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967681|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967682|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967683|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967684|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967685|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967686|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967687|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967688|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967689|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967690|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967691|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967692|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967693|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967694|NCT00905125|O1|Outcome|Fluzone®|Single 0.5 mL intramuscular injection of Fluzone®
967695|NCT00905125|O2|Outcome|Fluarix®|Single 0.5 mL intramuscular injection of Fluarix®
967705|NCT00905034|B1|Baseline|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
967706|NCT00905034|P1|Participant Flow|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
968130|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
967707|NCT00905034|O1|Outcome|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
967708|NCT00905034|E1|Reported Event|MOAD|Chemotherapy regimen of methotrexate, rituximab, vincristine, pegylated L-asparaginase and dexamethasone (MOAD). Methotrexate 200 mg/m^2 intravenous (IV) days 1 and 15, Vincristine 1.4 mg/m^2 IV days 1, 8 and 15; PEG-l-asparaginase 2500 International units/m^2 IV days 2 and 16; Dexamethasone 40 mg/day IV or oral days 1-4 & 15-18; Rituximab 375 mg/m^2 IV days 1 & 15 (first 4 cycles) for participants CD20 positive or positive by immunostain.
967709|NCT00905021|B1|Baseline|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
967710|NCT00905021|P1|Participant Flow|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
967711|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|This is a single arm study. All patients received Exemestane 25mg per day and Sunitinib 37.5 mg per day.
967712|NCT00905021|O1|Outcome|Exemestane Plus Sunitinib|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
967713|NCT00905021|E1|Reported Event|Exemestane Plus Sutent|"All patients enrolled on the study will receive treatment as follows:~Exemestane 25 mg by mouth every day.~Sunitinib 37.5 mg by mouth every day."
967714|NCT00904995|B3|Baseline|Total|Total of all reporting groups
967715|NCT00904995|B2|Baseline|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
967716|NCT00904995|B1|Baseline|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
967717|NCT00904995|P2|Participant Flow|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
967718|NCT00904995|P1|Participant Flow|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
967719|NCT00904995|O2|Outcome|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
967720|NCT00904995|O1|Outcome|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
967721|NCT00904995|E2|Reported Event|Group 2 - IV + Oral|Voriconazole 6 mg/kg by vein (IV) first dose then 200 mg pills two times a day thereafter.
967722|NCT00904995|E1|Reported Event|Group 1 - Oral|Voriconazole starting oral dose of 400 mg pills twice a day for first day, followed by 200 mg by mouth twice a day thereafter.
967723|NCT00904982|B5|Baseline|Total|Total of all reporting groups
967724|NCT00904982|B4|Baseline|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
967725|NCT00904982|B3|Baseline|3 Incentive Group/Lottery|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken
967726|NCT00904982|B2|Baseline|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
967787|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967921|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
967727|NCT00904982|B1|Baseline|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
967728|NCT00904982|P4|Participant Flow|4 Combined Group/Lottery and Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an"
967729|NCT00904982|P3|Participant Flow|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
967730|NCT00904982|P2|Participant Flow|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
967731|NCT00904982|P1|Participant Flow|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
967732|NCT00904982|O4|Outcome|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
967733|NCT00904982|O3|Outcome|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
967734|NCT00904982|O2|Outcome|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
967918|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
967735|NCT00904982|O1|Outcome|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
967736|NCT00904982|E4|Reported Event|4 Combined Group/Lottery and Reminder|Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled. Participants in this group will also be entered into a daily lottery. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin medication as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on an
967737|NCT00904982|E3|Reported Event|3 Incentive Group/Lottery|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant. This group will also be entered into a daily lottery in which he/she can win money. On any given study day, participants have a 1 in 10 chance of winning $10 and 1 in 100 chance of winning $100 when taking their warfarin as prescribed. Participants must take their dose correctly in order to be eligible for the daily lottery.~Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken"
967738|NCT00904982|E2|Reported Event|2Med-eMonitor/Reminder|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication and will be set on active mode for this group. The MM will display messages of encouragement to participants and education on the importance of taking their warfarin medication. The Med-eMonitor also features an alarm that will sound to remind participants to take their medication as scheduled.~2Med-eMonitor: Med-eMonitor is a device that subjects will be given that will monitor an individual's warfarin adherence."
967739|NCT00904982|E1|Reported Event|1 Usual Care Group/Control|"Participants in this study arm will be given an electronic medication monitoring system called a Med-eMonitor(MM) to use at home. This machine will measure the participant's adherence to taking their medication. The MM can display messages to the participant and can confirm when medication is taken correctly.Financial Incentive and Med-eMonitor: Financial Incentives: Study participants are entered into a daily lottery. It includes a chance to win either $10 or $100 on any given day throughout the participant's duration in the study (6 months). Participants are assigned a number and each day a computer randomly draws a winning number. Participants whose number is drawn can only collect money if they have taken the medication correctly.~Med-eMonitor: The Med-eMonitor is a device used to measure medication compliance. The device has 5 drawers in which the participants' medication is placed. When a drawer opens, a message displays on the monitor, and asks the participant if he/she"
967740|NCT00905840|B1|Baseline|Two Bone Level Implants in Interforaminal Region|"All patients received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon alloy. All implants were 3.3 mm in Ø, had a similar macro- and micro-structure, and had the chemically modified SLActive (Sand blasted Large grid Acid-etched) surface.~The implants were placed in the interforaminal region of the mandible, one implant in each side.~Implant placement was double-blinded as the implants are visually identical, and the study was unblinded after 12 month for the first analysis."
967741|NCT00905840|P1|Participant Flow|Titan Grade IV Implant and Titan Zircon Implant|Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Titan Zircon in the interforaminal region.
967742|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
967743|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
967744|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
967745|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth design~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
967919|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
967746|NCT00905840|O2|Outcome|Titan Zirkon Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
967747|NCT00905840|O1|Outcome|Titan Grade IV Implant|"split-mouth~Patients with edentulous mandibles received two Straumann bone-level implants, one of Ti Grade IV and one of Ti-Tr, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month."
967932|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
967748|NCT00905840|E1|Reported Event|Two Bone Level Implants in Interforaminal Region|Patients with edentulous mandibles received two Straumann bone-level implants, one of Titan Grade IV and one of Titan Zircon, in the interforaminal region. Implants were loaded after 6-8 weeks and removable Locator-retained overdentures were placed within 2 weeks of loading. Modified plaque and sulcus bleeding indices, radiographic bone level, and implant survival and success were evaluated up to 36 month.
967749|NCT00905827|B4|Baseline|Total|Total of all reporting groups
967750|NCT00905827|B3|Baseline|Control|Control: no training
967751|NCT00905827|B2|Baseline|Intervention: E-training CAMS|Intervention: e-training CAMS training for providers
967752|NCT00905827|B1|Baseline|Intervention 1: In-person CAMS|Intervention: in-person CAMS training for providers
967753|NCT00905827|P3|Participant Flow|Control|Control: no training
967754|NCT00905827|P2|Participant Flow|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
967755|NCT00905827|P1|Participant Flow|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
967756|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
967757|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
967758|NCT00905827|O3|Outcome|Control|Control: no training
967759|NCT00905827|O2|Outcome|Intervention 2: E-learning CAMS|Intervention: e-learning CAMS training
967760|NCT00905827|O1|Outcome|Intervention 1: In-person CAMS|Intervention: in-person CAMS training
967761|NCT00905827|E3|Reported Event|Arm 3|Control Group: no training
967762|NCT00905827|E2|Reported Event|Arm 2|"Intervention: e-learning CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
967763|NCT00905827|E1|Reported Event|Arm 1|"Intervention: in person CAMS training for providers~CAMS: Collaborative assessment management in suicidality"
967764|NCT00905632|B8|Baseline|Total|Total of all reporting groups
967765|NCT00905632|B7|Baseline|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967766|NCT00905632|B6|Baseline|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967767|NCT00905632|B5|Baseline|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967768|NCT00905632|B4|Baseline|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967769|NCT00905632|B3|Baseline|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967770|NCT00905632|B2|Baseline|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967771|NCT00905632|B1|Baseline|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967772|NCT00905632|P7|Participant Flow|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
967773|NCT00905632|P6|Participant Flow|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
967774|NCT00905632|P5|Participant Flow|Treatment Experienced (TE): BI 207127 400 mg|Treatment Experienced (TE) patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
967775|NCT00905632|P4|Participant Flow|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
967776|NCT00905632|P3|Participant Flow|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
967777|NCT00905632|P2|Participant Flow|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA (given as a tablet, orally three times daily (tid)) + Peg-IFN (injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
967778|NCT00905632|P1|Participant Flow|Treatment Naive (TN): Placebo|Treatment Naive (TN) patients to receive Placebo (given as a tablet, orally three times daily (tid)) + Peg-IFN (Peginterferon alfa (Peg-IFN) injection, sub-cutaneously once a week) + Ribavirin (tablet, orally twice daily (bid)) for 28 days
967779|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967780|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967781|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967782|NCT00905632|O1|Outcome|Placebo|Patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967783|NCT00905632|O4|Outcome|BI 207127 800 mg|Patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967784|NCT00905632|O3|Outcome|BI 207127 600 mg|Patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967785|NCT00905632|O2|Outcome|BI 207127 400 mg|Patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967788|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967789|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967790|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967791|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967792|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967795|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967796|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967797|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967798|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967799|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967800|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967801|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967802|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967803|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967804|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967805|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967806|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967807|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967808|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967809|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967810|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967811|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967812|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967813|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967814|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967815|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967816|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967817|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967818|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967819|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967820|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967821|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967822|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967823|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967824|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967825|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967826|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967827|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967828|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967829|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967830|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967831|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967832|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967833|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967834|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967835|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967836|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967837|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967838|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967839|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967840|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967841|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967842|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967843|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967844|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967845|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967846|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967847|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967848|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967849|NCT00905632|O4|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967850|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967851|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967852|NCT00905632|O1|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967853|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967854|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967855|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967856|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967857|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967858|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967859|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967860|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967861|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967862|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967863|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967864|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967865|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967866|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967867|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967868|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967869|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967870|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967871|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967872|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967873|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967920|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
967874|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967875|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967876|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967877|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967878|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967879|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967880|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
982854|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
967881|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967882|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967883|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967884|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967885|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967886|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967887|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967888|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967889|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967890|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967891|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967892|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967893|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967894|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967895|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967896|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967897|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967898|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967899|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967900|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967901|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967902|NCT00905632|O7|Outcome|Treatment Experienced (TE): BI 207127 800 mg|TE patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967903|NCT00905632|O6|Outcome|Treatment Experienced (TE): BI 207127 600 mg|TE patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967904|NCT00905632|O5|Outcome|Treatment Experienced (TE): BI 207127 400 mg|TE patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967905|NCT00905632|O4|Outcome|Treatment Naive (TN): BI 207127 800 mg|TN patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967906|NCT00905632|O3|Outcome|Treatment Naive (TN): BI 207127 600 mg|TN patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967907|NCT00905632|O2|Outcome|Treatment Naive (TN): BI 207127 400 mg|TN patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967908|NCT00905632|O1|Outcome|Treatment Naive (TN): Placebo|TN patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967909|NCT00905632|E4|Reported Event|BI 207127 800 mg|patients to receive 800mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967910|NCT00905632|E3|Reported Event|BI 207127 600 mg|patients to receive 600mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967911|NCT00905632|E2|Reported Event|BI 207127 400 mg|patients to receive 400mg BI 207127 NA tablet + Peg-IFN + Ribavirin tid for 28 days
967912|NCT00905632|E1|Reported Event|Placebo|patients to receive Placebo + Peg-IFN + Ribavirin tid for 28 days
967913|NCT00905606|B3|Baseline|Total|Total of all reporting groups
967914|NCT00905606|B2|Baseline|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product, dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product, dosed in second period
967915|NCT00905606|B1|Baseline|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product, dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product, dosed in second period
967916|NCT00905606|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablets, 2 x 25 mg reference product dosed in first period followed by Topiramate Tablets, 2 x 25 mg test product dosed in second period
967917|NCT00905606|P1|Participant Flow|Topiramate (Test) First|Topiramate Tablets, 2 x 25 mg test product dosed in first period followed by Topomax® Tablets, 2 x 25 mg reference product dosed in second period.
967922|NCT00905606|O2|Outcome|Topomax® (Reference)|Topamax® Tablets, 2 x 25 mg
967923|NCT00905606|O1|Outcome|Topiramate (Test)|Topiramate Tablets, 2 x 25 mg
967924|NCT00905580|B3|Baseline|Total|Total of all reporting groups
967925|NCT00905580|B2|Baseline|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
967926|NCT00905580|B1|Baseline|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
967927|NCT00905580|P2|Participant Flow|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
967928|NCT00905580|P1|Participant Flow|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
967929|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
967930|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
967931|NCT00905580|O2|Outcome|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
967936|NCT00905580|O1|Outcome|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
967937|NCT00905580|E2|Reported Event|Pregabalin|Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later
967938|NCT00905580|E1|Reported Event|Placebo|Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later
967939|NCT00905567|B3|Baseline|Total|Total of all reporting groups
967940|NCT00905567|B2|Baseline|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
967941|NCT00905567|B1|Baseline|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
967942|NCT00905567|P2|Participant Flow|Topamax® (Reference) First|Topamax® Tablet 2 x 25 mg (reference) dosed in first period followed by Topiramate 2 x 25 mg Tablet (test) dosed in second period
967943|NCT00905567|P1|Participant Flow|Topiramate (Test) First|Topiramate 2 x 25 mg Tablet (test)dosed in first period followed by Topamax® 2 x 25 mg Tablet (reference) dosed in second period
967944|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
967945|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
967946|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
967947|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
967948|NCT00905567|O2|Outcome|Topamax®|Topamax® Tablet 2 x 25 mg
967949|NCT00905567|O1|Outcome|Topiramate|Topiramate 2 x 25 mg Tablet
967950|NCT00905554|B3|Baseline|Total|Total of all reporting groups
967951|NCT00905554|B2|Baseline|Air Insufflation|air insufflation during the insertion phase of colonoscopy
967952|NCT00905554|B1|Baseline|Warm Water|warm water irrigation during the insertion phase of colonoscopy
967953|NCT00905554|P2|Participant Flow|Air Insufflation|air insufflation during the insertion phase of colonoscopy
967954|NCT00905554|P1|Participant Flow|Warm Water|warm water irrigation during the insertion phase of colonoscopy
967955|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
967956|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
967957|NCT00905554|O2|Outcome|Air Insufflation|air insufflation during the insertion phase of colonoscopy
967958|NCT00905554|O1|Outcome|Warm Water|warm water irrigation during the insertion phase of colonoscopy
967959|NCT00905554|E2|Reported Event|Air Insufflation|air insufflation during the insertion phase of colonoscopy
967960|NCT00905554|E1|Reported Event|Warm Water|warm water irrigation during the insertion phase of colonoscopy
967961|NCT00905515|B4|Baseline|Total|Total of all reporting groups
967962|NCT00905515|B3|Baseline|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
967963|NCT00905515|B2|Baseline|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
967964|NCT00905515|B1|Baseline|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
967965|NCT00905515|P3|Participant Flow|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
967966|NCT00905515|P2|Participant Flow|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced Tacrolimus (TAC) with target trough levels 3.0-5.9 ng/mL."
967967|NCT00905515|P1|Participant Flow|Remaining on CsA|Stable transplant recipients randomly assigned to continue on Cyclosporine (CsA( with a target trough level of 50-250 ng/mL.
967968|NCT00905515|O3|Outcome|Standard TAC|"Stable transplant recipients randomly assigned to convert to standard TAC with target trough levels of 6.0-8.9 ng/mL."
967969|NCT00905515|O2|Outcome|Reduced TAC|"Stable transplant recipients randomly assigned to convert to reduced TAC with target trough levels 3.0-5.9 ng/mL."
967970|NCT00905515|O1|Outcome|Remaining on CsA|Stable transplant recipients randomly assigned to continue on CSA with a target trough level of 50-250 ng/mL.
967971|NCT00905515|E3|Reported Event|Standard TAC|Patients were converted from CsA to TAC with trough concentrations of 6.0-8.9 ng/mL
967972|NCT00905515|E2|Reported Event|Reduced TAC|Patients converted from CsA to TAC with trough concentrations 3.0-5.9 ng/mL
967973|NCT00905515|E1|Reported Event|Remaining on CsA|Patients remained on CSA and were not converted to TAC.
967974|NCT00905489|B1|Baseline|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
968030|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
967975|NCT00905489|P1|Participant Flow|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
967976|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
967977|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
967978|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
967979|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
967980|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
967981|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
967982|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
967983|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
967984|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
967985|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
967986|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
967987|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
967988|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
967989|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
967990|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
967991|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
967992|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
967993|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
967994|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
967995|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
967996|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
967997|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
967998|NCT00905489|O4|Outcome|Total.|All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
967999|NCT00905489|O3|Outcome|12-<18 yr|Patients 12 to < 18 years old.
968000|NCT00905489|O2|Outcome|6-<12 yr|Patients 6 to < 12 years old.
968001|NCT00905489|O1|Outcome|3-<6 yr|Patients 3 to < 6 years old.
968002|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968003|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968004|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968005|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968006|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968007|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968008|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968009|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968010|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968011|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968012|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968013|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968014|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968015|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968016|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968017|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968018|NCT00905489|O2|Outcome|NVP IR|Nevirapine IR (immediate release)
968019|NCT00905489|O1|Outcome|NVP XR|Nevirapine XR (extended release)
968020|NCT00905489|E1|Reported Event|Total.|"All patients enrolled in study.~All patients initially receive nevirapine immediate release (IR) and then all patients are switched to nevirapine extended release (XR) 100mg or 400mg tablets for a once daily dosing of 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP)."
968021|NCT00905437|B3|Baseline|Total|Total of all reporting groups
968022|NCT00905437|B2|Baseline|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968023|NCT00905437|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968024|NCT00905437|P2|Participant Flow|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968025|NCT00905437|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968026|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968027|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968028|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968029|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968031|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968032|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968033|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968034|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968035|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968036|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968037|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968038|NCT00905437|O2|Outcome|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968039|NCT00905437|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968040|NCT00905437|E2|Reported Event|Placebo|Placebo matched to pregabalin 75 mg capsule orally twice daily for 14 days.
968041|NCT00905437|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily for 14 days.
968042|NCT00905424|B3|Baseline|Total|Total of all reporting groups
968123|NCT00905346|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
968043|NCT00905424|B2|Baseline|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
968044|NCT00905424|B1|Baseline|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
968045|NCT00905424|P2|Participant Flow|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
968046|NCT00905424|P1|Participant Flow|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
968047|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968048|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968049|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968050|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968051|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968052|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968053|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968116|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968117|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968425|NCT00904371|E1|Reported Event|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968054|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968055|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968124|NCT00905346|B1|Baseline|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
968125|NCT00905346|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
968056|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968057|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968058|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968059|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968060|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968061|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968062|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968063|NCT00905424|O2|Outcome|Antidepressant + Placebo (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968064|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by non-remitters and remitters. Remitters were defined as subjects who had an MADRS total score of less than or equal to 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968065|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968066|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968067|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968624|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968068|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968069|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968070|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968071|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968072|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968073|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968074|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968075|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968076|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968077|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968078|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968079|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968080|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968081|NCT00905424|O2|Outcome|Antidepressant + Placebo (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (placebo). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + placebo for 6 weeks.
968625|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968082|NCT00905424|O1|Outcome|Antidepressant + SPD489 (Non-remitters)|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (SPD489). At augmentation baseline, randomization was stratified by Non-remitters and remitters. Non-remitters were defined as subjects who had an MADRS total score of greater than 10 at augmentation baseline. Subjects received antidepressant (escitalopram @ 20 mg/day) + an optimal dose of SPD489 (either 20, 30, or 50 mg/day) for 6 weeks.
968083|NCT00905424|E2|Reported Event|Antidepressant + Placebo .|Subjects with residual depressive symptoms after the 8-week lead-in period with antidepressant were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + placebo) for 6 weeks. This includes both non-remitters and remitters.
968126|NCT00905346|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules 2 x 25 mg (reference) dosed in second period
968084|NCT00905424|E1|Reported Event|Antidepressant + SPD489|Subjects with residual depressive symptoms (symptoms of depression that remain after initial antidepressant treatment) after the 8-week lead-in period with antidepressant (escitalopram @ 20 mg/day) were randomly assigned to receive augmentation therapy (antidepressant @ 20 mg/day + SPD489 @ either 20, 30, or 50 mg/day) for 6 weeks. This includes both non-remitters (Montgomery-Ǻsberg Depression Rating Scale [MADRS] total score greater than 10 at augmentation baseline) and remitters (MADRS total score of less than or equal to 10 at augmentation baseline).
968085|NCT00905359|B3|Baseline|Total|Total of all reporting groups
968086|NCT00905359|B2|Baseline|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968087|NCT00905359|B1|Baseline|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968088|NCT00905359|P2|Participant Flow|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968089|NCT00905359|P1|Participant Flow|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968090|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968091|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968092|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968093|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968094|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968095|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968096|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968097|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968098|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968099|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968100|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968101|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968102|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968103|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968104|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968105|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968106|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968107|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968108|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968109|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968110|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968111|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968112|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968113|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968114|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968115|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968270|NCT00904917|B2|Baseline|Adapted PIP (Children)|Children of the mother-child dyad in the adapted PIP intervention.
968118|NCT00905359|O2|Outcome|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968119|NCT00905359|O1|Outcome|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968120|NCT00905359|E2|Reported Event|Standalone Decompressive Surgery|Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion.
968121|NCT00905359|E1|Reported Event|Aperius™ PercLID™ System|Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System.
968122|NCT00905346|B3|Baseline|Total|Total of all reporting groups
968131|NCT00905346|O2|Outcome|Topamax® Reference|Topamax® 2 x 25 mg Capsule dosed in either period
968132|NCT00905346|O1|Outcome|Topiramate (Test)|Topiramate Capsules 2 x 25 mg dosed in either period
968133|NCT00905307|B7|Baseline|Total|Total of all reporting groups
968134|NCT00905307|B6|Baseline|Placebo|Placebo QD for 6 weeks
968135|NCT00905307|B5|Baseline|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968136|NCT00905307|B4|Baseline|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968137|NCT00905307|B3|Baseline|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968138|NCT00905307|B2|Baseline|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968139|NCT00905307|B1|Baseline|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968140|NCT00905307|P6|Participant Flow|Placebo|Placebo QD for 6 weeks
968141|NCT00905307|P5|Participant Flow|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968142|NCT00905307|P4|Participant Flow|OPC-34712 High Dose|5.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968143|NCT00905307|P3|Participant Flow|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968144|NCT00905307|P2|Participant Flow|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968145|NCT00905307|P1|Participant Flow|OPC-34712 0.25 mg|0.25 mg once daily (QD) for 6 weeks
968146|NCT00905307|O6|Outcome|Placebo|Placebo QD
968147|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968148|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
968149|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968150|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physicna could request a dose increase, if needed for efficacy, based on clinical judgment.
968151|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968152|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
968153|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968154|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968155|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968156|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968157|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968158|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
968159|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968160|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968161|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968162|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968163|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968164|NCT00905307|O6|Outcome|Placebo|Placebo QD
968165|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968166|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968167|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968168|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968169|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
968170|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
982855|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
968171|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968172|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968173|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968174|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968175|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968176|NCT00905307|O6|Outcome|Placebo|Placebo QD
968177|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968178|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968179|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968180|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg After a minimum of 2 weeks of treatment (eg, beginning at the Week 2 visit and at any subsequent visit where study medication was dispensed), the investigator could request a dose increase, if needed for efficacy, based on clinical judgment.
968181|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD
968182|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
968183|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg.After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968184|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968185|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968186|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968187|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968188|NCT00905307|O6|Outcome|Placebo|Placebo QD for 6 weeks
968189|NCT00905307|O5|Outcome|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
968190|NCT00905307|O4|Outcome|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
968191|NCT00905307|O3|Outcome|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment , the physician could request a dose increase, if needed for efficacy, based on clinical judgment
968192|NCT00905307|O2|Outcome|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
968193|NCT00905307|O1|Outcome|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968194|NCT00905307|E6|Reported Event|Placebo|Placebo QD
968195|NCT00905307|E5|Reported Event|Aripiprazole|15 mg QD starting dose ± 5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment
968196|NCT00905307|E4|Reported Event|OPC-34712 High-dose|5.0 mg QD starting dose ± 1.0 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968626|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968197|NCT00905307|E3|Reported Event|OPC-34712 Mid-dose|2.5 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968198|NCT00905307|E2|Reported Event|OPC-34712 Low-dose|1.0 mg QD starting dose ± 0.5 mg. After a minimum of 2 weeks of treatment, the physician could request a dose increase, if needed for efficacy, based on clinical judgment.
968199|NCT00905307|E1|Reported Event|OPC-34712 0.25 mg|0.25 mg QD for 6 weeks
968200|NCT00905268|B5|Baseline|Total|Total of all reporting groups
968201|NCT00905268|B4|Baseline|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968202|NCT00905268|B3|Baseline|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968203|NCT00905268|B2|Baseline|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968204|NCT00905268|B1|Baseline|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968205|NCT00905268|P4|Participant Flow|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968358|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
968206|NCT00905268|P3|Participant Flow|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968207|NCT00905268|P2|Participant Flow|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968208|NCT00905268|P1|Participant Flow|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968209|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968210|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968211|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968212|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968213|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968214|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968215|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968216|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968217|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968218|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968219|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968220|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968221|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968222|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968223|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968224|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968225|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968226|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968227|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968271|NCT00904917|B1|Baseline|Adapted PIP (Mothers)|Mothers of the mother-child dyad in the adapted PIP intervention.
968228|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968229|NCT00905268|O4|Outcome|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968230|NCT00905268|O3|Outcome|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968231|NCT00905268|O2|Outcome|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968232|NCT00905268|O1|Outcome|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968233|NCT00905268|E4|Reported Event|D: Placebo|"placebo~Placebo: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968234|NCT00905268|E3|Reported Event|C: Idebenone|"Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968359|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
968235|NCT00905268|E2|Reported Event|Group B: Idebenone|"Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968236|NCT00905268|E1|Reported Event|Group A: Idebenone|"Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day~idebenone: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals."
968237|NCT00905255|B3|Baseline|Total|Total of all reporting groups
968238|NCT00905255|B2|Baseline|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
968239|NCT00905255|B1|Baseline|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
968240|NCT00905255|P2|Participant Flow|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 2 weeks, then 20 mcg QD up to end of treatment.
968241|NCT00905255|P1|Participant Flow|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to end of treatment.
968242|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968243|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968244|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968245|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
968246|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
968247|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968248|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968249|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968250|NCT00905255|O2|Outcome|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
968251|NCT00905255|O1|Outcome|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
968252|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968253|NCT00905255|O1|Outcome|Lixisenatide (Combined)|Included all patients who received 2-step initiation regimen of lixisenatide or 1-step initiation regimen of lixisenatide.
968254|NCT00905255|E2|Reported Event|Lixisenatide (One-step Titration)|1-step initiation regimen of lixisenatide.
968255|NCT00905255|E1|Reported Event|Lixisenatide (Two-step Titration)|2-step initiation regimen of lixisenatide.
968256|NCT00904943|B3|Baseline|Total|Total of all reporting groups
968257|NCT00904943|B2|Baseline|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
968258|NCT00904943|B1|Baseline|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
968259|NCT00904943|P2|Participant Flow|Topamax® (Reference) First|Topamax® Capsules, 2 x 25 mg (reference) dosed in first period followed by Topiramate Capsules, 2 x 25 mg (test) dosed in second period
968260|NCT00904943|P1|Participant Flow|Topiramate (Test) First|Topiramate Capsules, 2 x 25 mg (test) dosed in first period followed by Topamax® Capsules, 2 x 25 mg (reference) dosed in second period
968261|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
968262|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
968263|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
968264|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
968265|NCT00904943|O2|Outcome|Topamax® (Reference)|Topamax® Capsules, 2 x 25 mg dosed in either period
968266|NCT00904943|O1|Outcome|Topiramate (Test)|Topiramate Capsules, 2 x 25 mg dosed in either period
968267|NCT00904917|B5|Baseline|Total|Total of all reporting groups
968268|NCT00904917|B4|Baseline|Lecture (Children)|Children of the mother-child dyad in the lecture control group.
968269|NCT00904917|B3|Baseline|Lecture (Mothers)|Mothers of the mother-child dyad in the lecture control group.
968272|NCT00904917|P4|Participant Flow|Lecture (Children)|"Children of mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
968273|NCT00904917|P3|Participant Flow|Lecture (Mothers)|"Mothers who received education about depression.~Psychoeducation : Two 1-hour sessions focusing on psychoeducation about depression and its impact on children and the family."
968274|NCT00904917|P2|Participant Flow|Adapted PIP (Children)|"Children of the mother-child dyad in the adapted PIP intervention for families of children with a depressed African American Mother.~Intervention Project: Eight 1 hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies"
968275|NCT00904917|P1|Participant Flow|Adapted PIP (Mothers)|"Mothers participated in an adapted PIP for the families of children with a depressed African American mother.~Prevention Intervention Project : Eight 1-hour sessions, tailored as required to meet the clinical and cultural needs of each family. Intervention focuses on education, coping with stress, and cognitive-behavioral strategies."
968276|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
968277|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
968641|NCT00903383|E2|Reported Event|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968278|NCT00904917|O2|Outcome|Adapted PIP (Child)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
968279|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
968280|NCT00904917|O4|Outcome|Lecture (Child)|Mothers received psychoeducation about depression. The intervention was psychoeducation.
968281|NCT00904917|O3|Outcome|Lecture (Mother)|Mothers received psychoeducation about depression.
968282|NCT00904917|O2|Outcome|Adapted PIP (Child)|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
968283|NCT00904917|O1|Outcome|Adapted PIP (Mother)|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
968284|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
968285|NCT00904917|O1|Outcome|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Prevention Intervention Project.
968286|NCT00904917|O2|Outcome|Lecture|Mothers received psychoeducation about depression. The intervention was psychoeducation.
968287|NCT00904917|O1|Outcome|Adapted PIP|"Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother.~The intervention was the Prevention Intervention Project."
968288|NCT00904917|E2|Reported Event|Lecture|Mothers received psychoeducation about depression.
968289|NCT00904917|E1|Reported Event|Adapted PIP|Participants (both mother and children) participated in an adapted cognitive family prevention program for the families of children with a depressed African American mother. The intervention was the Preventive Intervention Project.
968290|NCT00904839|B3|Baseline|Total|Total of all reporting groups
968291|NCT00904839|B2|Baseline|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968292|NCT00904839|B1|Baseline|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968293|NCT00904839|P3|Participant Flow|Bevacizumab 5 mg + mFolfox6 (Phase II)|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968294|NCT00904839|P2|Participant Flow|Nintedanib 200 mg + mFolfox6|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968295|NCT00904839|P1|Participant Flow|Nintedanib 150 mg + mFolfox6|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968296|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968297|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968298|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968299|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
968348|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
968300|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968301|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968302|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968303|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968304|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
982856|NCT00857649|E2|Reported Event|Placebo|Oral Tablets Once Daily
968305|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968306|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968307|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
968308|NCT00904839|O2|Outcome|Nintedanib 200 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968309|NCT00904839|O1|Outcome|Nintedanib 150 mg + mFolfox6 (Phase I)|Patients receiving nintedanib 150 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
968310|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968311|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968312|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968313|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968314|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968315|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968316|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968317|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968318|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968319|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968320|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968321|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968322|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968349|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
968323|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968324|NCT00904839|O2|Outcome|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week in a form of a bottles (injection concentrate solution) plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968325|NCT00904839|O1|Outcome|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily in a form of a soft gelatine capsule plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
968326|NCT00904839|E2|Reported Event|Bevacizumab + mFolfox6|Patients receiving bevacizumab 5 mg/kg every other week plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion)
968327|NCT00904839|E1|Reported Event|Nintedanib + mFolfox6|Patients receiving nintedanib 150 mg or 200 mg twice daily plus mFolfox6: oxaliplatin 85 mg/m², l-leucovorin 200 mg/m² or d, l-leucovorin 400 mg/m², 5-fluorouracil 400 mg/m² (bolus) and 2400 mg/m² (infusion).
968328|NCT00904826|B1|Baseline|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968329|NCT00904826|P1|Participant Flow|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968330|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968331|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968332|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968333|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968334|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968335|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968336|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968337|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968338|NCT00904826|O1|Outcome|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968339|NCT00904826|E1|Reported Event|Eculizumab|The patient will receive eculizumab at a dose of 600mg intravenously (an infusion given into the vein) each week for 4 weeks, then 900mg intravenously at the fifth week, then 900mg every 2 weeks for 48 weeks. Subjects will receive therapy for a total of 12 months.
968340|NCT00904748|B1|Baseline|Entire Study Population|Includes all participants who were randomized to any treatment sequence
968341|NCT00904748|P6|Participant Flow|Sequence 6|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
968342|NCT00904748|P5|Participant Flow|Sequence 5|Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
968343|NCT00904748|P4|Participant Flow|Sequence 4|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water
968344|NCT00904748|P3|Participant Flow|Sequence 3|Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
968345|NCT00904748|P2|Participant Flow|Sequence 2|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water), Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water)
968346|NCT00904748|P1|Participant Flow|Sequence 1|Reference (Sildenafil 100 milligram (mg) coated tablet administered with water, Test 1 (Sildenafil 100 milligram (mg) chewable tablet administered without water), Test 2 (Sildenafil 100 milligram (mg) chewable tablet administered with water)
968347|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
968421|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968350|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
968351|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
968352|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
968353|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
968354|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
968355|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
968356|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
968357|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
968642|NCT00903383|E1|Reported Event|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968360|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
968361|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
968362|NCT00904748|O3|Outcome|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
968363|NCT00904748|O2|Outcome|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
968364|NCT00904748|O1|Outcome|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
968365|NCT00904748|E4|Reported Event|Formulation Unspecified|Sildenafil 100 mg tablet: formulation unspecified
968366|NCT00904748|E3|Reported Event|Reference: 100 mg Coated, With Water|Reference Formulation: Viagra (sildenafil citrate) 100 mg coated tablet administered with water
968367|NCT00904748|E2|Reported Event|Test 2: 100 mg Chewable, With Water|Test 2 Formulation: Sildenafil citrate 100 mg chewable tablet administered with water
968368|NCT00904748|E1|Reported Event|Test 1: 100 mg Chewable, Without Water|Test 1 Formulation: Sildenafil citrate 100 milligram (mg) chewable tablet administered without water
968369|NCT00904722|B1|Baseline|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
968370|NCT00904722|P1|Participant Flow|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
968371|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
968372|NCT00904722|O1|Outcome|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
968373|NCT00904722|E1|Reported Event|Pidilizumab (CT-011)|Combination of the immunotherapy drugs, CT-011 and Rituximab. CT-011: Administered intravenously at a dose of 3.0 mg/kg on days 1, 29 (+/- 7 days), 57 (+/- 7 days), and 85 (+/- 7 days). Rituximab: Administered intravenously at the standard dose of 375 mg/m^2 weekly for 4 weeks on days 17 (+/- 1 day), 24 (+/- 1 day), 31 (+/- 1 day), and 38 (+/- 1 day).
968374|NCT00904670|B1|Baseline|Entire Study Population|Includes all randomized participants who received at least 1 dose of study medication.
968375|NCT00904670|P2|Participant Flow|OL Phase (NWP06); DB Phase (NWP06 First, Then Placebo)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the first intervention period followed by placebo-matched to NWP06 oral suspension once daily for 1 week in the second intervention period.
968376|NCT00904670|P1|Participant Flow|OL Phase (NWP06); DB Phase (Placebo First, Then NWP06)|Placebo-matched to NWP06 oral suspension once daily for 1 week in the first intervention period followed by NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in the second intervention period.
968377|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
968378|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968379|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
968380|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968381|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention period.
968382|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968383|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
968384|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968385|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
968386|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968387|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
968388|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968389|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
968390|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968391|NCT00904670|O2|Outcome|Placebo|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods.
968392|NCT00904670|O1|Outcome|NWP06|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day) for 1 week in either of the 2 intervention periods.
968393|NCT00904670|E3|Reported Event|DB Phase (NWP06)|NWP06 oral suspension at a once daily optimized dose (optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60mg/day) for 1 week in either of the 2 intervention periods of the DB phase.
968394|NCT00904670|E2|Reported Event|DB Phase (Placebo)|Placebo-matched to NWP06 oral suspension once daily for 1 week in either of the 2 intervention periods of the DB phase.
968395|NCT00904670|E1|Reported Event|OL Phase (NWP06)|NWP06 oral suspension once daily optimized during the 4 to 6 weeks open label phase at a starting dose of 20 milligram [mg] and titrated at a 10 or 20 mg increments, based on clinical response and tolerability to a maximum daily dose of 60 mg/day.
968396|NCT00904618|B1|Baseline|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
968397|NCT00904618|P1|Participant Flow|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
968398|NCT00904618|O2|Outcome|U-Method|The ‘U-Method’ is similar to the retropubic tape dissection.
968399|NCT00904618|O1|Outcome|'Hammock' Technique|The ‘Hammock’ technique is similar to the transobturator tape dissection.
968400|NCT00904618|O2|Outcome|U-Method|The U-Method is similar to the retropubic tape dissection
968401|NCT00904618|O1|Outcome|'Hammock' Technique|The 'Hammock' technique is similar to the transobturator tape dissection.
968402|NCT00904618|O1|Outcome|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
968403|NCT00904618|E1|Reported Event|TVT-SECUR|This study arm consisted of 48 women operated from January 2007 to October 2008. All patients underwent the implantation of the TVT-SECUR for the treatment of stress urinary incontinence or stress predominant mixed urinary incontinence. The surgery was done under local anesthesia by one high-volume surgeon.
968404|NCT00904423|B1|Baseline|Vitamin D|
968405|NCT00904423|P1|Participant Flow|Vitamin D|
968406|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
968407|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
968408|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
968409|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
968410|NCT00904423|O1|Outcome|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
968411|NCT00904423|E1|Reported Event|Vitamin D|Vitamin D: up to 2400 mg; oral tablet
968412|NCT00904371|B1|Baseline|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
968413|NCT00904371|P1|Participant Flow|Micardis® 80mg; MicardisPlus® 80/12.5 mg|
968414|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968415|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968416|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968417|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968418|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968419|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968420|NCT00904371|O1|Outcome|Micardis® 80mg MicardisPlus® 80/12.5 mg|
968426|NCT00904215|B1|Baseline|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
968427|NCT00904215|P1|Participant Flow|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
968428|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
968429|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
968430|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
968431|NCT00904215|O1|Outcome|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
968432|NCT00904215|E1|Reported Event|Micardis/Micardis Plus|Patients aged 18~80 with hypertension who took Micardis/Micardis Plus
968433|NCT00904189|B1|Baseline|1Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
968434|NCT00904189|P1|Participant Flow|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
968643|NCT00903370|B3|Baseline|Total|Total of all reporting groups
990230|NCT00840294|B3|Baseline|Total|Total of all reporting groups
968435|NCT00904189|O1|Outcome|1 Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
968436|NCT00904189|O1|Outcome|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
968437|NCT00904189|E1|Reported Event|Subjects Receiving Incidental Radiation Dose to Fingernails.|"Subjects receiving incidental radiation dose to fingernails.~Standard of care given for treatment of cancer: Subjects receiving a known dose of radiation during Total Body Irradiation."
968438|NCT00904150|B3|Baseline|Total|Total of all reporting groups
968439|NCT00904150|B2|Baseline|2 No Migraine|Caucasian women with no personal history of migraine
968440|NCT00904150|B1|Baseline|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968441|NCT00904150|P2|Participant Flow|2 No Migraine|Caucasian women with no personal history of migraine
968442|NCT00904150|P1|Participant Flow|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968443|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
968444|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968445|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
968446|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968447|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
968448|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968449|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
968450|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968451|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
968452|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968453|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
968454|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968455|NCT00904150|O2|Outcome|2 No Migraine|Caucasian women with no personal history of migraine
968456|NCT00904150|O1|Outcome|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968457|NCT00904150|E2|Reported Event|2 No Migraine|Caucasian women with no personal history of migraine
968458|NCT00904150|E1|Reported Event|1 Menstrual Migraine|Caucasian women with a current or past history of menstrual migraine (MM = pure menstrual migraine or menstrually-related migraine) attending the City of London Migraine Clinic
968459|NCT00904007|B3|Baseline|Total|Total of all reporting groups
968460|NCT00904007|B2|Baseline|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
968461|NCT00904007|B1|Baseline|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
968462|NCT00904007|P2|Participant Flow|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
968463|NCT00904007|P1|Participant Flow|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
968464|NCT00904007|O2|Outcome|Control Cohort|Control clinicians received identical educational content in an online posting with email reminders.
968627|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968465|NCT00904007|O1|Outcome|SE Game Cohort|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
968466|NCT00904007|E2|Reported Event|Arm 2|Control clinicians received identical educational content in an online posting with email reminders.
968467|NCT00904007|E1|Reported Event|Arm 1|SE game clinicians were e-mailed one question every 3 days. Adaptive game mechanics re-sent questions in 12 or 24 days if answered incorrectly or correctly, respectively. Clinicians retired questions by answering each correctly twice consecutively. Posting of relative performance among peers fostered competition.
968468|NCT00903929|B1|Baseline|Eltrombopag|Eltrombopag: dose escalation
968469|NCT00903929|P4|Participant Flow|Eltrombopag 300 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
990515|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
968470|NCT00903929|P3|Participant Flow|Eltrombopag 225 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
968471|NCT00903929|P2|Participant Flow|Eltrombopag 150 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
968472|NCT00903929|P1|Participant Flow|Eltrombopag 75 mg|Dose escalation was based on a standard 3+3 design. A group of 3 patients were enrolled at a given dose level; if none of these patients experienced dose-limiting toxicity (DLT), then the dose could be escalated. If 1 of the 3 patients experienced DLT, then 3 more patients would be enrolled at the same dose level. If no additional patients experienced a DLT, then dose escalation could occur, but if 2 or more of the 6 patients experienced a DLT, then that dose would be the MTD.
968473|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
968474|NCT00903929|O1|Outcome|Eltrombopag|Eltrombopag: dose escalation
968475|NCT00903929|O1|Outcome|All Participants|
968476|NCT00903929|E1|Reported Event|Eltrombopag|Eltrombopag: dose escalation
968477|NCT00902850|B3|Baseline|Total|Total of all reporting groups
968478|NCT00902850|B2|Baseline|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
968479|NCT00902850|B1|Baseline|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
968480|NCT00902850|P2|Participant Flow|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
968481|NCT00902850|P1|Participant Flow|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
968482|NCT00902850|O2|Outcome|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
968483|NCT00902850|O1|Outcome|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
968484|NCT00902850|E2|Reported Event|Marketed 1 Day Contact Lens|"Marketed 1 Day Contact Lens~Marketed 1 Day Contact Lens: Lenses to be worn for 8-16 hours"
968485|NCT00902850|E1|Reported Event|SofLens Daily Disposable|"SofLens Daily Disposable Lenses~SofLens Daily Disposable: Lenses to be worn for 8-16 hours"
968486|NCT00903695|B3|Baseline|Total|Total of all reporting groups
968487|NCT00903695|B2|Baseline|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
968488|NCT00903695|B1|Baseline|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
968489|NCT00903695|P2|Participant Flow|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
968490|NCT00903695|P1|Participant Flow|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
977375|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
968491|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968492|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968493|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968571|NCT00903409|E2|Reported Event|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
968494|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968495|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968496|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968497|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968498|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968499|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968500|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968501|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968502|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968503|NCT00903695|O2|Outcome|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
968504|NCT00903695|O1|Outcome|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
968505|NCT00903695|O2|Outcome|Placebo Arm|Subjects who were assigned by VA research pharmacist to receive placebo pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968506|NCT00903695|O1|Outcome|Nutriceutical Arm|Subjects who were assigned by VA research pharmacist to receive nutriceutical pills for full 12 months of study. They were told to take one pill each in AM and PM, and spouse kept a log of the time of day when subject injected the pill. Logs were brought to PI each three months when patient returned to lab for re-testing and to receive next batch of study pills.
968541|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968628|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968629|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968507|NCT00903695|E2|Reported Event|Placebo Effects on Cognition/Behavior|Mild Cognitive Impairment subjects will take the placebo that has been formulated to look and taste the same as the nutriceutical being studied (Memory XL). Subjects will be cognitively & behaviorally assessed each 3 months of the study, with last testing done at the end of their 12 months of pill ingestion. Tests used in each arm of study are the same ones used in prior publications by the nutriceutical inventor, Dr. Shea, when he assessed mild, moderate, and severely demented Alzheimer's patients. The current study is double blind, whereas Dr. Shea's studies were open label.
968543|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968638|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
990516|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
968508|NCT00903695|E1|Reported Event|Nutriceutical (MemoryXL) Effects on Cognition & Behavior|Subjects diagnosed with Mild Cognitive Impairment (MCI) will take 2 Memory XL pills daily for 12 months (a vitamin nutriceutical developed by Thomas Shea, Ph.D., and patented by the Univ. of Mass.). They will be assessed cognitively each 3 months to determine if Memory XL prevents them from progressing to early dementia; 10-25% of MCI patients have been shown to convert to dementia each year. Therefore, at least 10% of patients in study would be expected to progress from MCI to early Alzheimer's dementia during the year of the study.
968509|NCT00903682|B3|Baseline|Total|Total of all reporting groups
968510|NCT00903682|B2|Baseline|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968511|NCT00903682|B1|Baseline|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
968512|NCT00903682|P2|Participant Flow|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968513|NCT00903682|P1|Participant Flow|Etravirine|Etravirine (ETR TMC125) 400mg once daily (4x100mg tablet) + 2 NRTI + 1 EFV placebo tablet for 48 weeks
968514|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968515|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
968516|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968517|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
968518|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968519|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
968520|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968521|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
968522|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968523|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
968524|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968525|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
968526|NCT00903682|O2|Outcome|Efavirenz|Efavirenz (EFV) 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968527|NCT00903682|O1|Outcome|Etravirine|Etravirine (ETR, TMC125) 400mg once daily (4x100mg tablet) + 2 non-nucleoside reverse transcriptase inhibitors (NRTIs) + 1 Efavirenz (EFV) placebo tablet for 48 weeks
968528|NCT00903682|E2|Reported Event|Efavirenz|EFV 600mg once daily (1x600mg tablet) + 2 NRTIs + 4 ETR placebo tablets for 48 weeks
968529|NCT00903682|E1|Reported Event|Etravirine|ETR 400mg once daily (4x100mg tablet) + 2 NRTIs + 1 EFV placebo tablet for 48 weeks
968530|NCT00903630|B4|Baseline|Total|Total of all reporting groups
968531|NCT00903630|B3|Baseline|Phase 2|
968532|NCT00903630|B2|Baseline|Phase 1 - Dose Level 2|
968533|NCT00903630|B1|Baseline|Phase 1 - Dose Level 1|
968534|NCT00903630|P3|Participant Flow|Phase 2 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days
968535|NCT00903630|P2|Participant Flow|Phase 1 - Dose Level 2|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days
968536|NCT00903630|P1|Participant Flow|Phase 1 - Dose Level 1|liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days
968537|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin fpr recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968538|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968539|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968540|NCT00903630|O2|Outcome|Phase I - Dose Level 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 15 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968542|NCT00903630|O3|Outcome|Phase 2|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: maximum tolerated dose from Phase I portion of the study (10mg) daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968639|NCT00903383|E4|Reported Event|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
993267|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
968544|NCT00903630|O1|Outcome|Phase 1 - Dose Level 1|"liposomal doxorubicin: 40mg/m2 IV Day 1 every 28 days plus lenalidomide: 10 mg daily on Days 1-28 every 28 days~Lenalidomide: administered by mouth at the assigned dose daily for each 28 day cycle~liposomal doxorubicin: administered at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968545|NCT00903630|O1|Outcome|Lenalidomide With Liposomal Doxorubicin|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose; beginning at 10 mg and schedule of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968546|NCT00903630|E3|Reported Event|Phase 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968547|NCT00903630|E2|Reported Event|Phase 1 - Dose Level 2|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 15 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968548|NCT00903630|E1|Reported Event|Phase 1 - Dose Level 1|"Patients treated with a combination of lenalidomide and liposomal doxorubicin for recurrent epithelia ovarian, fallopian tube or primary peritoneal cancer.~Lenalidomide: Administered by mouth at the assigned dose of 10 mg daily of each 28 day cycle~pegylated liposomal doxorubicin hydrochloride: Liposomal doxorubicin at a fixed dose of 40 mg/m^2 intravenously (IV) on day 1 of each 28 day cycle"
968549|NCT00903448|B1|Baseline|Entire Study Population|
968550|NCT00903448|P2|Participant Flow|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
968551|NCT00903448|P1|Participant Flow|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
968552|NCT00903448|O2|Outcome|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
968553|NCT00903448|O1|Outcome|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
968554|NCT00903448|E2|Reported Event|Prevacid Then Prilosec OTC Then Prilosec OTC|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
968555|NCT00903448|E1|Reported Event|Prilosec OTC Then Prevacid Then Prevacid|This study was a 3-period crossover (ABB, BAA). Prilosec OTC (20.6 mg omeprazole magnesium tablet) and Prevacid (15 mg lansoprazole capsule) were administered daily before breakfast.
968556|NCT00903409|B3|Baseline|Total|Total of all reporting groups
968557|NCT00903409|B2|Baseline|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
968558|NCT00903409|B1|Baseline|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
968559|NCT00903409|P2|Participant Flow|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
968560|NCT00903409|P1|Participant Flow|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
968561|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
968562|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
968563|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
968564|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
968565|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
968566|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
968567|NCT00903409|O3|Outcome|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
968622|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968623|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968568|NCT00903409|O2|Outcome|Switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. Switched from Placebo/Simvastatin 40 mg/day administered in an earlier double-blind study (111858: NCT00903409).
968569|NCT00903409|O1|Outcome|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
968570|NCT00903409|E3|Reported Event|Total Non-switcher and Switcher|Non-switcher and Switcher groups combined
968640|NCT00903383|E3|Reported Event|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968572|NCT00903409|E1|Reported Event|Non-switcher|Open-label Lovaza® (omega-3-acid ethyl esters) [formerly known as Omacor®] 4 g/day and Simvastatin 40 mg/day. These are the same drugs as administered in an earlier double-blind study (111858: NCT00903409).
968573|NCT00903396|B5|Baseline|Total|Total of all reporting groups
968574|NCT00903396|B4|Baseline|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968575|NCT00903396|B3|Baseline|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968576|NCT00903396|B2|Baseline|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968577|NCT00903396|B1|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968578|NCT00903396|P4|Participant Flow|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968579|NCT00903396|P3|Participant Flow|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968580|NCT00903396|P2|Participant Flow|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968581|NCT00903396|P1|Participant Flow|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968582|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968583|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968584|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968585|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968586|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968587|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968588|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968589|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968590|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968591|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968592|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968593|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968594|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968595|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968596|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968597|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968598|NCT00903396|O4|Outcome|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968599|NCT00903396|O3|Outcome|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968600|NCT00903396|O2|Outcome|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968601|NCT00903396|O1|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968602|NCT00903396|E4|Reported Event|Arm IV|"Patients receive placebo IV on days 1 and 4.~placebo: Given IV"
968603|NCT00903396|E3|Reported Event|Arm III|"Patients receive placebo IV on day 1.~placebo: Given IV"
968604|NCT00903396|E2|Reported Event|Arm II|"Patients receive palonosetron hydrochloride IV on days 1 and 4.~palonosetron hydrochloride: Given IV"
968605|NCT00903396|E1|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV on day 1.~palonosetron hydrochloride: Given IV"
968606|NCT00903383|B5|Baseline|Total|Total of all reporting groups
968607|NCT00903383|B4|Baseline|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968608|NCT00903383|B3|Baseline|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968609|NCT00903383|B2|Baseline|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968610|NCT00903383|B1|Baseline|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968611|NCT00903383|P4|Participant Flow|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968612|NCT00903383|P3|Participant Flow|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968613|NCT00903383|P2|Participant Flow|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968614|NCT00903383|P1|Participant Flow|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968615|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968616|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968617|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968618|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968619|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968620|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968621|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
977376|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
968630|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968631|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968632|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968633|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968634|NCT00903383|O1|Outcome|Low Dose|A low dose of LX3305; daily oral intake for 12 weeks
968635|NCT00903383|O4|Outcome|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
968636|NCT00903383|O3|Outcome|High Dose|A high dose of LX3305; daily oral intake for 12 weeks
968637|NCT00903383|O2|Outcome|Mid Dose|A mid dose of LX3305; daily oral intake for 12 weeks
968644|NCT00903370|B2|Baseline|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
968645|NCT00903370|B1|Baseline|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
968646|NCT00903370|P2|Participant Flow|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
968647|NCT00903370|P1|Participant Flow|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
968648|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
968649|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
968650|NCT00903370|O2|Outcome|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
968651|NCT00903370|O1|Outcome|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
968675|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
977377|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
968652|NCT00903370|E2|Reported Event|MVS + Ablation|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage plus surgical ablation with pulmonary vein isolation or biatrial lesion set.~MVS + ablation: For participants treated by pulmonary vein isolation, two separate encircling lesions will be made around the left and right pulmonary veins.~For participants treated with biatrial maze lesion set, the left atrial lesions will include the two encircling lesions, as well as connecting lesions between to the pulmonary veins, from the pulmonary veins to the mitral valve annulus, and from the pulmonary veins to the left atrial appendage. The right pulmonary veins will be isolated first. Isolation will be confirmed by pacing the pulmonary veins at the previously identified threshold for capture. If no atrial capture noted, it will be inferred that the right pulmonary veins were isolated. If atrial capture noted, additional ablations on the atrial cuff will be performed until isolation is confirmed."
968653|NCT00903370|E1|Reported Event|MVS Alone|"Participants will undergo mitral valve surgery with ligation/excision of left atrial appendage.~MVS alone: All participants will have their left atrial appendage excised or excluded. For mitral regurgitation, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, and for most cases of mitral stenosis, a valve replacement will be performed."
968654|NCT00903357|B1|Baseline|Entire Study Population|Includes groups randomized to receive Montelukast first and placebo first.
968655|NCT00903357|P2|Participant Flow|Placebo First, Then Montelukast|Placebo(chewable ascorbic acid) once daily in first intervention period and Montelukast(4mg or 5mg) once daily in second intervention period (after washout period).
968656|NCT00903357|P1|Participant Flow|Montelukast First, Then Placebo|Montelukast(4mg or 5mg) once daily in first intervention period and placebo(chewable ascorbic acid) once daily in second intervention period (after washout period).
968657|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine EDN after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
968658|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine EDN after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary EDN before and after taking Montelukast sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
968659|NCT00903357|O2|Outcome|Placebo Drug|Changes of Urine LTE4 after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
968660|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of Urine LTE4 after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of urinary LTE4 before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
968661|NCT00903357|O2|Outcome|Placebo Drug|Changes of SCORAD index after taking Placebo drug. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking placebo drug in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
968662|NCT00903357|O1|Outcome|Montelukast Sodium|Changes of SCORAD index after taking Montelukast Sodium. Patients were randomized to receive either montelukast(4 mg for under the age of 6 years, 5mg for 6 years and over) once daily or a chewable ascorbic acid placebo, which was comparable in size and color to the study drug for 8 weeks and cross-over for 8 weeks after 2 weeks wash-out period. We have collected data of SCORAD index before and after taking Montelukst Sodium in both group(Montelukast first, then placebo, and Placebo first, then Montelukast)
968663|NCT00903357|E2|Reported Event|Placebo Drug|Placebo drug administered once daily in either first intervention period or second intervention period.
968664|NCT00903357|E1|Reported Event|Montelukast Sodium|Montelukast sodium(4mg or 5mg) administered once daily in either first intervention period or second intervention period.
968665|NCT00903344|B3|Baseline|Total|Total of all reporting groups
968666|NCT00903344|B2|Baseline|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968667|NCT00903344|B1|Baseline|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968668|NCT00903344|P2|Participant Flow|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968669|NCT00903344|P1|Participant Flow|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968670|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968671|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968672|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968673|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968674|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
977378|NCT00875420|E5|Reported Event|Placebo|Oral once a day for 28 days
968676|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968677|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968678|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968679|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968680|NCT00903344|O2|Outcome|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968681|NCT00903344|O1|Outcome|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968682|NCT00903344|E2|Reported Event|Multivitamin - Active Comparator|"Multivitamin with 400IU vitamin D tablet~Multivitamin: Multivitamin containing 400IU vitamin D in tablet taken daily"
968683|NCT00903344|E1|Reported Event|Vitamin D - Experimental|"4000IU Vitamin D3 in tablet taken daily with multivitamin~Vitamin D3: 4000IU vitamin D3 tablet taken daily"
968684|NCT00903331|B3|Baseline|Total|Total of all reporting groups
968685|NCT00903331|B2|Baseline|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
968686|NCT00903331|B1|Baseline|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
968687|NCT00903331|P2|Participant Flow|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
968688|NCT00903331|P1|Participant Flow|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
968689|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
968690|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
968691|NCT00903331|O2|Outcome|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
968692|NCT00903331|O1|Outcome|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
968693|NCT00903331|E2|Reported Event|ACT-064922|"ACT-064922 tablet, 10 mg, once daily~ACT-064992 (macitentan) : tablet, 10 mg, once daily"
968694|NCT00903331|E1|Reported Event|Placebo|"Matching placebo, once daily~Placebo : matching placebo, once daily"
968695|NCT00903175|B3|Baseline|Total|Total of all reporting groups
968696|NCT00903175|B2|Baseline|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968697|NCT00903175|B1|Baseline|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968698|NCT00903175|P2|Participant Flow|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968699|NCT00903175|P1|Participant Flow|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968700|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968701|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968702|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968703|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968704|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968705|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968706|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968707|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968708|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968709|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968710|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968711|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968712|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
970477|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
968713|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968714|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968715|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968716|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968717|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968718|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968719|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968720|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968721|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968722|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968723|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968724|NCT00903175|O2|Outcome|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968725|NCT00903175|O1|Outcome|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968726|NCT00903175|E2|Reported Event|Sunitinib 1L/Everolimus 2L|sunitinib First Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2) everolimus Second Line: 10 mg orally, once daily (two 5 mg tablets), continuous treatment
968727|NCT00903175|E1|Reported Event|Everolimus 1L/Sunitinib 2L|everolimus First Line: 10 mg orally, once daily, (two 5 mg tablets), continuous treatment. sunitinib Second Line: 50 mg orally, once daily, 4 weeks on treatment followed by 2 weeks off (4/2)
968728|NCT00903162|B1|Baseline|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
968729|NCT00903162|P1|Participant Flow|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
968730|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
968731|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
968732|NCT00903162|O1|Outcome|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
968733|NCT00903162|E1|Reported Event|Letrozole-Leuprolide|"Patients will receive 2.5mg oral letrozole daily and either 7.5mg monthly of Leuprolide IM or 22.5mg every three months of Leuprolide IM. Zoledronic acid 4mg IV every 6 months x 4 will also be offered optionally.~leuprolide: Given intramuscularly beginning on day 1 and then either 7.5 mg every month or 22.5 mg every 3 months for two years~letrozole: Taken orally once a day 6-8 weeks after initial leuprolide administration~zoledronic acid: If desired, given intravenously every 6 months for a total of 4 injections (optional)"
968734|NCT00903032|B3|Baseline|Total|Total of all reporting groups
969137|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
968735|NCT00903032|B2|Baseline|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
968736|NCT00903032|B1|Baseline|Patient Centered Intervention|The multi-faceted patient centered intervention adapts elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, PCPs, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs. Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.
968737|NCT00903032|P2|Participant Flow|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
968835|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968836|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968738|NCT00903032|P1|Participant Flow|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of re"
968739|NCT00903032|O2|Outcome|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
968740|NCT00903032|O1|Outcome|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens, and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
968741|NCT00903032|E2|Reported Event|Usual Care|"Patients will receive usual care following ACS hospital discharge~Usual care: Usual care following ACS hospital discharge."
968742|NCT00903032|E1|Reported Event|Patient Centered Intervention|"The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care (between pharmacists, primary care providers, and cardiologists), patient education (tailored to patient needs and provided on a regular ongoing basis), tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs.~Intervention: The multi-faceted patient centered intervention will adapt elements of prior successfully adherence interventions and include the following core components: collaborative care, patient education, tailoring of medication regimens (i.e., simplification of dosing, use of pill boxes, synchronization of refill dates), and tele-monitoring via IVR technology as well as patient-specific aides based on identified needs."
968743|NCT00903006|B5|Baseline|Total|Total of all reporting groups
968744|NCT00903006|B4|Baseline|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968745|NCT00903006|B3|Baseline|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
968746|NCT00903006|B2|Baseline|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968747|NCT00903006|B1|Baseline|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
968748|NCT00903006|P4|Participant Flow|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968749|NCT00903006|P3|Participant Flow|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
970478|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
968750|NCT00903006|P2|Participant Flow|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968751|NCT00903006|P1|Participant Flow|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
968752|NCT00903006|O4|Outcome|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968753|NCT00903006|O3|Outcome|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
968754|NCT00903006|O2|Outcome|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968755|NCT00903006|O1|Outcome|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
968756|NCT00903006|E4|Reported Event|Group 4: Fulvestrant, MK-0646 + Dasatinib|"Group 4 will receive Fulvestrant, MK-0646, and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968757|NCT00903006|E3|Reported Event|Group 3: Fulvestrant + MK-0646|"Group 3 will receive Fulvestrant and MK-0646.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~MK-0646: Group 3 or Group 4, receive starting dose of 5 mg/kg by vein on Days 1, 18, 15, and 22 of every cycle."
968758|NCT00903006|E2|Reported Event|Group 2: Fulvestrant + Dasatinib|"Group 2 will receive Fulvestrant and Dasatinib.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection.~Dasatinib: Group 2 or Group 4, starting dose of 70 mg (capsules) by mouth daily."
968759|NCT00903006|E1|Reported Event|Group 1: Fulvestrant|"Group 1 will receive Fulvestrant only.~Fulvestrant: Starting dose of 500 mg through a needle into muscle on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 and beyond. On Day 1 of Cycle 1, injections into 2 different muscles, all other times one injection."
968760|NCT00902746|B1|Baseline|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg, or Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
968761|NCT00902746|P1|Participant Flow|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
968762|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
968763|NCT00902746|O1|Outcome|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
968764|NCT00902746|E1|Reported Event|NPC-01|"Norethisterone, Ethinyl Estradiol~NPC-01: This study consist of the following steps.~Step 1(Norethisterone 0.6mg, Ethinyl Estradiol 0.035mg):From first study medication to 3th menstrual cycles.~Step 2(Norethisterone 1mg, Ethinyl Estradiol 0.035mg):~After interim analysis of the results of step 1, in the case of the efficacy results meet prespecified criterion, same dose level will be continued to 13th menstrual cycles including step 1. If the results do not meet prespecified criterion, the dose will be increased to Norethisterone 1mg, Ethinyl Estradiol 0.035mg and be continued newly until 13th menstrual cycle from this point."
968765|NCT00902668|B1|Baseline|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
968766|NCT00902668|P1|Participant Flow|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
968802|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968837|NCT00902330|O2|Outcome|Arm II|Sham CES
968767|NCT00902668|O1|Outcome|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
968768|NCT00902668|E1|Reported Event|Supportive Care (Lovastatin)|Patients undergo 25-28 fractions of standard whole-breast irradiation followed by a boost to the tumor bed or 10 fractions of accelerated partial-breast irradiation with balloon brachytherapy BID over 5-10 days. Patients also receive lovastatin PO QD for 12 months beginning on day 1 of radiation therapy. Treatment continues in the absence of disease progression or unacceptable toxicity.
968769|NCT00902564|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968770|NCT00902564|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968771|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968772|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968773|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968774|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968775|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968776|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968777|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968778|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968779|NCT00902564|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968780|NCT00902564|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968781|NCT00902538|B4|Baseline|Total|Total of all reporting groups
968782|NCT00902538|B3|Baseline|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968783|NCT00902538|B2|Baseline|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3
968784|NCT00902538|B1|Baseline|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
968785|NCT00902538|P6|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 oral tablets, given once daily, in double-blind, randomized, Period 4
968786|NCT00902538|P5|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals (non-responders) could receive OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets, given once daily, in double-blind, randomized, Period 4.
968787|NCT00902538|P4|Participant Flow|OLM 40-AML 10-HCTZ 12.5 (Responders)|Participants who meet their blood pressure goals (responded) in Period 3 and continued into 8-week, double-blind Period 4 continued to receive OLM 40-AML 10-HCTZ 12.5 oral tablets given once daily.
968788|NCT00902538|P3|Participant Flow|OLM 40-AML 10-HCTZ 25|Participants could start receiving OLM 40-AML 10-HCTZ 25 oral tablets, given once daily, in randomized, double-blind, 8- week Period 2.
968789|NCT00902538|P2|Participant Flow|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 oral tablets given once daily in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968790|NCT00902538|P1|Participant Flow|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received Olmesartan(OLM) 40 mg-Amlodipine(AML) 10 mg oral tablets, once a day, for the 8-week, single-blind, run-in Period 1. Then in Period 2, participants would be randomized to this same combination or have hydrochlorothiazide oral tablets (12.5 or 25 mg) added for an additional 8 weeks. All medication is given once a day.
968791|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968792|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968793|NCT00902538|O2|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968794|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968795|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
968796|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
968797|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
968798|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
968799|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 25 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
968800|NCT00902538|O1|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5 (Non-responders)|Participants finishing Period 3, but, who did not meet their blood pressure goals could receive this combination in the double-blind, randomized, Period 4
968801|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968803|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
968804|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968805|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968806|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
968807|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968808|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968809|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
968810|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968811|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968812|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
968813|NCT00902538|O3|Outcome|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968814|NCT00902538|O2|Outcome|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968815|NCT00902538|O1|Outcome|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
968816|NCT00902538|E3|Reported Event|OLM 40-AML 10-HCTZ 25|Participants could start receiving this combination in randomized, double-blind, 8- week Period 2.
968817|NCT00902538|E2|Reported Event|OLM 40-AML 10-Hydrochlorothiazide (HCTZ) 12.5|Participants could start receiving this combination in randomized, double-blind, 8-week Period 2. This combination was continued into single-blind, 8-week Period 3 for all participants entering Period 3.
968818|NCT00902538|E1|Reported Event|Olmesartan(OLM) 40 Mg-Amlodipine(AML) 10 mg|The participants in this arm received these 2 drugs for the 8-week, single-blind, run-in Period 1. Participants could then randomized to this same combination for an additional 8 weeks in the double-blind, Period 2.
968819|NCT00902330|B3|Baseline|Total|Total of all reporting groups
968820|NCT00902330|B2|Baseline|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
968821|NCT00902330|B1|Baseline|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
968822|NCT00902330|P2|Participant Flow|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
968823|NCT00902330|P1|Participant Flow|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
968824|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968825|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
969138|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
968826|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
968827|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968828|NCT00902330|O2|Outcome|Arm II|Sham CES
968829|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968830|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968831|NCT00902330|O2|Outcome|Arm II|Sham CES
968832|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968833|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968834|NCT00902330|O2|Outcome|Arm II|Sham CES
968838|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968839|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968840|NCT00902330|O2|Outcome|Arm II|Sham CES
968841|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968842|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968843|NCT00902330|O2|Outcome|Arm II|Sham CES
968844|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968845|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968846|NCT00902330|O2|Outcome|Arm II|Sham CES
968847|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968848|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968849|NCT00902330|O2|Outcome|Arm II|Sham CES
968850|NCT00902330|O1|Outcome|Arm I|Cranial Microcurrent Electrical Stimulation (CES)
968851|NCT00902330|O1|Outcome|All Patients Analyzed|All patients
968852|NCT00902330|O2|Outcome|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
968853|NCT00902330|O1|Outcome|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
968854|NCT00902330|E2|Reported Event|Arm II (Sham CES)|"Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.~sham intervention: Given once a day for 18 weeks"
968855|NCT00902330|E1|Reported Event|Arm I (Cranial Microcurrent Electrical Stimulation [CES])|"Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.~energy-based therapy: Given once a day for 18 weeks"
968856|NCT00902304|B4|Baseline|Total|Total of all reporting groups
968857|NCT00902304|B3|Baseline|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968858|NCT00902304|B2|Baseline|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968859|NCT00902304|B1|Baseline|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968860|NCT00902304|P3|Participant Flow|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968861|NCT00902304|P2|Participant Flow|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968862|NCT00902304|P1|Participant Flow|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
969139|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
968863|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968864|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968865|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
993973|NCT00830791|B7|Baseline|Total|Total of all reporting groups
968866|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968867|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968868|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968869|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968870|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968871|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968872|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968873|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968874|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968875|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968876|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968877|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968914|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
969140|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
968878|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968879|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968880|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968881|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968882|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968883|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968884|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968885|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968886|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968887|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968888|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968889|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968890|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968891|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968892|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968915|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
970479|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
968893|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968894|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968895|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968896|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968897|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968898|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968899|NCT00902304|O3|Outcome|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968900|NCT00902304|O2|Outcome|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968901|NCT00902304|O1|Outcome|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968902|NCT00902304|E4|Reported Event|Combination (Initial Combination Therapy Arm)|Physicians initially utilized single tablet combination products of either valsartan plus hydrochlorothiazide (HCTZ) or valsartan plus amlodipine for an initial 6 weeks of therapy (based on the treating physician's preference), with dose titrations (if required) every 4 weeks thereafter until week 10. The maximum dose for the HCTZ combination was valsartan 160mg plus HCTZ 25mg per day. The maximum dose for the amlodipine combination was valsartan 160mg plus amlodipine 10mg per day. For patients who were not at blood pressure target at week 14, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968903|NCT00902304|E3|Reported Event|Monotherapy (Initial Monotherapy Arm)|Physicians utilized valsartan 160mg per day for 6 weeks, followed by (if required) dose titrations every 4 weeks thereafter until week 14 (valsartan 320mg per day, then valsartan 320mg plus hydrochlorothiazide (HCTZ) 12.5mg per day, then valsartan 320mg plus HCTZ 25mg per day (maximal dose)). For patients not at blood pressure target at week 18, physicians were requested to consider triple or alternative therapy at their own discretion for the remainder of the study.
968904|NCT00902304|E2|Reported Event|Usual Care|Physicians applied their usual pattern of patient visits and treatment strategies to achieve individualized blood pressure target
968905|NCT00902304|E1|Reported Event|Pre-randomization|Pre-randomization
968906|NCT00902265|B1|Baseline|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968907|NCT00902265|P1|Participant Flow|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968908|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968909|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968910|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968911|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968912|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968913|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968916|NCT00902265|O1|Outcome|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968917|NCT00902265|E1|Reported Event|Desmopressin 0.1 mg|"Participants with benign prostate syndrome suffering from nocturia associated with nocturnal polyuria.~Drug given by prescription."
968918|NCT00902226|B1|Baseline|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968919|NCT00902226|P1|Participant Flow|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968920|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968921|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968922|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968923|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968924|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968925|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968926|NCT00902226|O1|Outcome|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968927|NCT00902226|E1|Reported Event|Escitalopram (5 to 20 mg Oral Tablets Daily)|
968928|NCT00902174|B3|Baseline|Total|Total of all reporting groups
968929|NCT00902174|B2|Baseline|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
968930|NCT00902174|B1|Baseline|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
968931|NCT00902174|P2|Participant Flow|Placebo|Placebo to imatinib mesylate taken once daily. Participants receiving placebo were allowed to receive already approved PAH treatments.
968932|NCT00902174|P1|Participant Flow|Imatinib Mesylate|Imatinib mesylate (QTI571) 200 mg once daily for two weeks, increased to 400 mg once daily if well tolerated. If 400 mg dose was not well tolerated, a down titration to 200 mg once daily was permitted.
968933|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
968934|NCT00902174|O1|Outcome|Imatinib 400 mg|imatinib mesylate 400 mg once daily
968935|NCT00902174|O2|Outcome|GCP74588|imatinib metabolite
968936|NCT00902174|O1|Outcome|Imatinib 200 mg|imatinib mesylate 200 mg once daily
968937|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968938|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968939|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968940|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968941|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968942|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968943|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968944|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968945|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968946|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968947|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968948|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968949|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968950|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968951|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968952|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968953|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968954|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968955|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968956|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968957|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968958|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968959|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968960|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968961|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968962|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968963|NCT00902174|O2|Outcome|Placebo|Placebo to imatinib
968964|NCT00902174|O1|Outcome|Imatinib|imatinib mesylate
968965|NCT00902174|E2|Reported Event|Placebo|Placebo to imatinib
968966|NCT00902174|E1|Reported Event|Imatinib|imatinib mesylate
968967|NCT00902161|B3|Baseline|Total|Total of all reporting groups
968968|NCT00902161|B2|Baseline|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968969|NCT00902161|B1|Baseline|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968970|NCT00902161|P3|Participant Flow|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week run-on before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranol titration through Visit 8 clamp procedures).
968971|NCT00902161|P2|Participant Flow|Propanolol + Placebo / Propanolol + MK0893|After a 4 week wash-out period with a 4-week propanolol run-on, MK0893-matched placebo was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893 on Day 21 (Visit 8) while continuing on propanolol.
968972|NCT00902161|P1|Participant Flow|Propanolol + MK0893 / Propanolol + Placebo|After a 4 week wash-out period with a 4-week propanolol run-on, single dose MK0893 was added on Day -1 of Period 1 (Study Visit 6) and propanolol was continued. After Period 1, participants underwent a 3-week wash-out while continuing to receive propanolol alone. Following the washout, participants were treated with a single dose of MK0893-matched placebo on Day 21 (Visit 8) while continuing on propanolol.
968973|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
969141|NCT00901576|E3|Reported Event|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
968974|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968975|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968976|NCT00902161|O3|Outcome|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
968977|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968978|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968979|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
994119|NCT00830219|B3|Baseline|Total|Total of all reporting groups
968980|NCT00902161|O1|Outcome|MK0893|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968981|NCT00902161|O2|Outcome|Placebo + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968982|NCT00902161|O1|Outcome|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968983|NCT00902161|E3|Reported Event|Propanolol Alone|Participants received treatment with propanolol alone during a 4 week washout before the 1st clamp procedure at Visit 6, and during a 3 week washout between clamp procedures at Visits 6 (Period 1) and 8 (Period 2). Overall, participants were treated with propranolol for approximately 7 weeks (from propranolol titration through Visit 8 clamp procedures).
968984|NCT00902161|E2|Reported Event|Placebo + Propanolol|Participants received a single dose of MK0893-matched placebo added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968985|NCT00902161|E1|Reported Event|MK0893 + Propanolol|Participants received a single dose of MK0893 added to a background of propanolol at either Visit 6 (Day -1) or Visit 8 (Day 21).
968986|NCT00901901|B3|Baseline|Total|Total of all reporting groups
968987|NCT00901901|B2|Baseline|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
968988|NCT00901901|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
968989|NCT00901901|P2|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
968990|NCT00901901|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
968991|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
968992|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
968993|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
968994|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
968995|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
968996|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
968997|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
968998|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
968999|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
969000|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
969001|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
969002|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
969003|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
969004|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY 43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
969005|NCT00901901|O2|Outcome|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
969006|NCT00901901|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
969007|NCT00901901|E2|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Placebo|Participants received sorafenib 400 mg twice daily (bid) and matching erlotinib placebo 150 mg tablet once daily (qd)
969008|NCT00901901|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Erlotinib (Tarceva)|Participants received sorafenib 400 mg twice daily (bid) and erlotinib 150 mg tablet once daily (qd)
969061|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969009|NCT00899574|B1|Baseline|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
969010|NCT00899574|P1|Participant Flow|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
969011|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
969012|NCT00899574|O1|Outcome|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
969013|NCT00899574|E1|Reported Event|Imiquimod|"Each treatment cycle consists of 8 weeks.~Weeks 1-8: day 1-5 of each week: 1 packet imiquimod 5% cream applied overnight, day 6-7 of each week: rest period.~Patients with responding or stable local disease (non-progressors) may continue to receive treatment following the same schedule (as outlined above for the first cycle) until complete tumor regression, unacceptable toxicity or progression of disease."
969014|NCT00899470|B1|Baseline|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
969015|NCT00899470|P4|Participant Flow|S/M (Fed)> S+M (Fed)> S+M (Fasted)> S/M (Fasted)|Participants were randomized to receive S/M (fed) followed by S+M (fed) followed by S+M (fasted) followed by S/M (fasted)
969016|NCT00899470|P3|Participant Flow|S+M (Fed)> S/M (Fasted) >S/M (Fed)> S+M (Fasted)|Participants were randomized to receive S + M (fed) followed by S/M (fasted) followed by S/M (fed) followed by S+M (fasted)
969017|NCT00899470|P2|Participant Flow|S/M (Fasted)> S+M (Fasted)> S+M (Fed)> S/M (Fed)|Participants were randomized to receive S/M (fasted) followed by S + M (fasted) followed by S + M (fed) followed by S/M (fed)
969018|NCT00899470|P1|Participant Flow|S+M (Fasted)> S/M (Fed)> S/M (Fasted)>S+M (Fed)|Participants were randomized to receive oral co-administration of a 2.5 mg tablet of saxagliptin plus a 500 mg tablet of metformin immediate release (IR) under fasted conditions (S + M [fasted]) followed by a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions (S/M [fed]) followed by S/M under fasting conditions (S/M [fasted]) followed by S + M under fed conditions (S + M [fed])
969019|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969020|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969021|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969022|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969023|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969024|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969025|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969026|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969027|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969028|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969029|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969030|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969059|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969060|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969136|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
969031|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
969032|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969033|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
969147|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
969034|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969035|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969036|NCT00899470|O5|Outcome|All Treated Participants|Participants were randomized to received 1 of 4 treatments 1)oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions, 2) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions, 3) oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions, or 4) a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions. Participants received all 4 treatments in 1 of 4 sequences: 1-4-2-3, 2-1-3-4, 3-2-4-1, or 4-3-1-2, with a washout period between treatments of at least 1 week.
969037|NCT00899470|O4|Outcome|Saxagliptin/Metformin (Fed)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969038|NCT00899470|O3|Outcome|Co-administration of Saxagliptin and Metformin IR (Fed)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fed conditions
969039|NCT00899470|O2|Outcome|Saxagliptin/Metformin (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969040|NCT00899470|O1|Outcome|Co-administration of Saxagliptin and Metformin IR (Fasted)|Participants received oral co-administration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969041|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969042|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969043|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969044|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969045|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969046|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969047|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969048|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969049|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969050|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969051|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969052|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969053|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969054|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969055|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969056|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969057|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969058|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969062|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969063|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969064|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969065|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969066|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
996350|NCT00824382|O1|Outcome|Placebo|Placebo
969067|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969068|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969069|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969070|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969071|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969072|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969073|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969074|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969075|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969076|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969077|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969078|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969079|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969080|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969081|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969082|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969083|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969084|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969085|NCT00899470|O4|Outcome|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969086|NCT00899470|O3|Outcome|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969087|NCT00899470|O2|Outcome|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed-dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969088|NCT00899470|O1|Outcome|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969089|NCT00899470|E4|Reported Event|Saxagliptin/Metformin FDC (Fed)|Participants received a single oral dose of an FDC tablet of 2.5 mg saxagliptin/500 mg metformin IR under fed conditions
969090|NCT00899470|E3|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fed)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin IR under fed conditions
969091|NCT00899470|E2|Reported Event|Saxagliptin/Metformin FDC (Fasted)|Participants received a single oral dose of a fixed dose combination (FDC) tablet of 2.5 mg saxagliptin/500 mg metformin IR under fasting conditions
969092|NCT00899470|E1|Reported Event|Coadministration of Saxagliptin and Metformin IR (Fasted)|Participants received oral coadministration of a 2.5 mg tablet of saxagliptin and a 500 mg tablet of metformin immediate release (IR) under fasted conditions
969093|NCT00901628|B3|Baseline|Total|Total of all reporting groups
969094|NCT00901628|B2|Baseline|No Injection Group|usual postoperative care without periarticular injection
969095|NCT00901628|B1|Baseline|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969096|NCT00901628|P2|Participant Flow|No Injection Group|usual postoperative care using the continuous femoral nerve block, IV-PCA and preemptive oral medications without periarticular injection
969097|NCT00901628|P1|Participant Flow|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969098|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
969099|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969100|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
969101|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969102|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
1025146|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
969103|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969104|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
969105|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969106|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
969107|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969108|NCT00901628|O2|Outcome|No Injection Group|usual postoperative care without periarticular injection
969109|NCT00901628|O1|Outcome|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969110|NCT00901628|E2|Reported Event|No Injection Group|usual postoperative care without periarticular injection
969111|NCT00901628|E1|Reported Event|Periarticular Injection Group|Periarticular injection with ropivacaine, morphine, ketorolac, epinephrine, cefuroxime
969112|NCT00901576|B7|Baseline|Total|Total of all reporting groups
969113|NCT00901576|B6|Baseline|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
969114|NCT00901576|B5|Baseline|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
969115|NCT00901576|B4|Baseline|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
969116|NCT00901576|B3|Baseline|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
969117|NCT00901576|B2|Baseline|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
969118|NCT00901576|B1|Baseline|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
969119|NCT00901576|P6|Participant Flow|SPD503 + Concerta First, Then Concerta, Then SPD503|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 single 4 mg dose in third intervention
969120|NCT00901576|P5|Participant Flow|SPD503 + Concerta First, Then SPD503, Then Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, Concerta single 36 mg dose in third intervention
969121|NCT00901576|P4|Participant Flow|Concerta First, Then SPD503 + Concerta, Then SPD503|Concerta single 36 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, SPD503 single 4 mg dose in third intervention
969122|NCT00901576|P3|Participant Flow|Concerta First, Then SPD503, Then SPD503 + Concerta|Concerta single 36 mg dose in first intervention, washout, SPD503 single 4 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
969123|NCT00901576|P2|Participant Flow|SPD503 First, Then SPD503 + Concerta, Then Concerta|SPD503 single 4 mg dose in first intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in second intervention, washout, Concerta single 36 mg dose in third intervention
969124|NCT00901576|P1|Participant Flow|SPD503 First, Then Concerta, Then SPD503 + Concerta|SPD503 single 4 mg dose in first intervention, washout, Concerta single 36 mg dose in second intervention, washout, SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered in third intervention
969125|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
969126|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
969127|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
969128|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
969129|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
969130|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
969131|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
969132|NCT00901576|O1|Outcome|Concerta Alone|Single 36 mg dose of extended-release Methylphenidate HCl
969133|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
969134|NCT00901576|O1|Outcome|SPD503 Alone|Single 4 mg dose of extended-release Guanfacine HCl
969135|NCT00901576|O2|Outcome|SPD503 + Concerta|SPD503 (single 4 mg dose) + Concerta (single 36 mg dose) coadministered
969142|NCT00901576|E2|Reported Event|Concerta Alone|Single 36 mg dose of extended-release methylphenidate HCl
969143|NCT00901576|E1|Reported Event|SPD503 Alone|Single 4 mg dose of extended-release guanfacine HCl
969144|NCT00901459|B1|Baseline|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
969145|NCT00901459|P1|Participant Flow|All Study Participants|"Active:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus~Location Control:~rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex~Frequency Control:~rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus"
969146|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
969148|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
969149|NCT00901459|O3|Outcome|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTMS Location: Superior Frontal Gyrus
969150|NCT00901459|O2|Outcome|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Motor Cortex
969151|NCT00901459|O1|Outcome|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTMS Location: Superior Frontal Gyrus
969152|NCT00901459|E3|Reported Event|Frequency Control|rTMS Dosing: 90% MT (Motor Threshold) 10 Hz rTNS Location: Superior Frontal Gyrus
969153|NCT00901459|E2|Reported Event|Location Control|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Motor Cortex
969154|NCT00901459|E1|Reported Event|Active|rTMS Dosing: 90% MT (Motor Threshold) 1 Hz rTNS Location: Superior Frontal Gyrus
969155|NCT00901342|B1|Baseline|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
969156|NCT00901342|P1|Participant Flow|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
969157|NCT00901342|O1|Outcome|Sipuleucel-T|All subjects who received ≥ one sipuleucel-T infusion
969158|NCT00901342|E1|Reported Event|Sipuleucel-T|Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions
969159|NCT00901316|B3|Baseline|Total|Total of all reporting groups
969160|NCT00901316|B2|Baseline|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
969161|NCT00901316|B1|Baseline|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
969162|NCT00901316|P2|Participant Flow|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
969163|NCT00901316|P1|Participant Flow|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
969164|NCT00901316|O2|Outcome|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
969165|NCT00901316|O1|Outcome|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
969166|NCT00901316|E2|Reported Event|Bleach Baths|Bleach Bath Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. Patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections. Patients will be given further oral and written instructions regarding clorox baths.
969198|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
969199|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
969167|NCT00901316|E1|Reported Event|Routine Measures|Routine Measures Group: Cultures will be obtained from the anterior nares of the nose, the throat and the groin using separate culturette swabs. S. aureus isolates will be identified and antibiotic susceptibility determined. Isolates will subsequently undergo testing for susceptibility to methicillin to determine if the isolate is an MSSA or MRSA strain. All patients and parents will be instructed orally and provided written instructions about routine measures employed for the prevention of S. aureus skin infections.
969168|NCT00901225|B1|Baseline|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969169|NCT00901225|P1|Participant Flow|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969170|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969171|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969172|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969173|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969174|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969175|NCT00901225|O1|Outcome|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969176|NCT00901225|E1|Reported Event|G-CSF Plus Plerixafor|Patients who were unable to mobilize a minimum number of cells (CD34+ cell count <20 cells/ul)following 5 days of G-CSF mobilization.
969177|NCT00901186|B3|Baseline|Total|Total of all reporting groups
969178|NCT00901186|B2|Baseline|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969179|NCT00901186|B1|Baseline|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969180|NCT00901186|P2|Participant Flow|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969181|NCT00901186|P1|Participant Flow|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969182|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969183|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969184|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969185|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969186|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969187|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969188|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969189|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969190|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969191|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969192|NCT00901186|O2|Outcome|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969193|NCT00901186|O1|Outcome|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969194|NCT00901186|E2|Reported Event|Laser Photocoagulation|At least one treatment of laser photocoagulation was applied on day 1. The maximum number of laser photocoagulation treatments was 4.
969195|NCT00901186|E1|Reported Event|RFB002|RFB002 0.5 mg was administered to the study eye with a single monthly intravitreal injection on day 1, day 30 and day 60. After day 90, if stable vision was not achieved, a monthly injection of RFB002 0.5 mg was administered until stable vision was achieved.
969196|NCT00901017|B1|Baseline|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
969197|NCT00901017|P1|Participant Flow|Straumann BoneCeramic and Geistlich Bio-Oss|Each patient received both treatments in a split-mouth design.
970480|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
969200|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
969201|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
969202|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
969203|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
969204|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland)
1025147|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
969205|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
969206|NCT00901017|O2|Outcome|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
969207|NCT00901017|O1|Outcome|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
969208|NCT00901017|E2|Reported Event|Geistlich Bio-Oss|The control site will be treated with a granular bone substitute derived from bovine bone (Bio-Oss - Geistlich Biomaterials, Wollhusen, Switzerland).
969209|NCT00901017|E1|Reported Event|Straumann BoneCeramic|In the test site the bone grafting procedure will be done with a synthetic biphasic calcium phosphate in particulate form (Straumann Bone Ceramic, Institute Straumann AG, Switzerland).
969210|NCT00900822|B1|Baseline|Straumann Bone Ceramic|Synthetic bone graft material
969211|NCT00900822|P1|Participant Flow|Straumann BoneCeramic|Synthetic bone graft material
969212|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
969213|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
969214|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
969215|NCT00900822|O1|Outcome|Straumann BoneCeramic|Synthetic bone graft material
969216|NCT00900822|O2|Outcome|BioOss|Xenograft bone graft material
969217|NCT00900822|O1|Outcome|Straumann Bone Ceramic|Synthetic bone graft material
969218|NCT00900822|E2|Reported Event|BioOss|Xenograft bone graft material
969219|NCT00900822|E1|Reported Event|Straumann Bone Ceramic|Synthetic bone graft material
969220|NCT00900796|B1|Baseline|Anti-tumor Necrosis Factor Agents (Evaluable Population)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-TNF agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, in Phase 1 of the study and who were eligible for the analysis.
969221|NCT00900796|P1|Participant Flow|Anti-tumor Necrosis Factor Agents|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
969222|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
969223|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
969224|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
969225|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
969226|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
969227|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 2)|Participants with active AS who did not respond to anti-TNF treatment in Phase 1 of the study, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week, and switched to another anti-TNF treatment in Phase 2 as per investigator’s discretion.
969228|NCT00900796|O1|Outcome|Anti-tumor Necrosis Factor Agents (Phase 1)|Participants with active ankylosing spondylitis (AS) who were prescribed with an anti-tumor necrosis factor (anti-TNF) agent, either etanercept 50 milligram (mg) once weekly or 25 mg twice weekly subcutaneously (s.c.) or infliximab infusion 5 mg per kilogram (mg/kg) body weight intravenously (IV) at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study.
969229|NCT00900796|E1|Reported Event|Anti-tumor Necrosis Factor Agents|Participants with active AS who were prescribed with an anti-TNF agent, either etanercept 50 mg once weekly or 25 mg twice weekly s.c. or infliximab infusion 5 mg/kg body weight IV at Week 0, 2, 6, 14 and 22 or adalimumab 40 mg s.c. every other week in Phase 1 of the study and if no response was observed, treatment was changed as per investigator’s discretion in Phase 2 of the study.
969230|NCT00900757|B1|Baseline|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969470|NCT00900029|B5|Baseline|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
969231|NCT00900757|P1|Participant Flow|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969232|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969233|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969234|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969235|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969236|NCT00900757|O1|Outcome|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969237|NCT00900757|E1|Reported Event|Palonosetron|"Single Arm trial of Palonosetron for the prevention of RINV in primary malignant glioma patients receiving radiation therapy (RT) and concomitant temozolomide (TMZ)~Palonosetron (PALO): Eligible patients should receive a planned total dose of 54-60 GY of radiation and 75 mg/m2 of daily temozolomide for a total of six weeks of treatment. For each week of radiation patients will receive a single 0.25 mg intravenous dose of palonosetron 30 minutes before each week of radiation fraction. This schedule will be repeated for each week of radiation for a total of 6 weeks."
969238|NCT00900731|B3|Baseline|Total|Total of all reporting groups
969239|NCT00900731|B2|Baseline|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969240|NCT00900731|B1|Baseline|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969241|NCT00900731|P2|Participant Flow|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969242|NCT00900731|P1|Participant Flow|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969243|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969244|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969245|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969246|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969247|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969248|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969249|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969250|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969251|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969252|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969253|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969254|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969255|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969256|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969257|NCT00900731|O2|Outcome|Tiotropium 18 µg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969258|NCT00900731|O1|Outcome|Indacaterol 150 µg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969259|NCT00900731|E2|Reported Event|Tiotropium 18 μg|Participants received tiotropium 18 μg delivered via the manufacturer's proprietary inhalation device (HandiHaler®) plus placebo to indacaterol delivered via a single-dose dry-powder inhaler (SDDPI) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969260|NCT00900731|E1|Reported Event|Indacaterol 150 μg|Participants received indacaterol 150 μg delivered via a single-dose dry-powder inhaler (SDDPI) plus placebo to tiotropium delivered via the manufacturer's proprietary inhalation device (HandiHaler®) once daily in the morning. Participants were permitted to take salbutamol/albuterol as a rescue medication.
969261|NCT00899392|B3|Baseline|Total|Total of all reporting groups
969262|NCT00899392|B2|Baseline|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
969263|NCT00899392|B1|Baseline|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
969264|NCT00899392|P2|Participant Flow|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
969265|NCT00899392|P1|Participant Flow|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
969266|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
969267|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
969268|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
969269|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
969270|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
969271|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
969272|NCT00899392|O2|Outcome|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
969273|NCT00899392|O1|Outcome|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
969274|NCT00899392|E2|Reported Event|Control Consent (FBC)|Form-based informed consent as performed by pediatric gastroenterologists
969275|NCT00899392|E1|Reported Event|Electronic Assisted Consent (EAC)|Standard form-based procedural consent performed by pediatric gastroenterologist plus assistance from computerized Emmi module.
969276|NCT00899379|B6|Baseline|Total|Total of all reporting groups
969471|NCT00900029|B4|Baseline|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
969277|NCT00899379|B5|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969278|NCT00899379|B4|Baseline|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969279|NCT00899379|B3|Baseline|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969280|NCT00899379|B2|Baseline|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969281|NCT00899379|B1|Baseline|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969282|NCT00899379|P5|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969283|NCT00899379|P4|Participant Flow|Rizatriptan/Rizatriptan/Rizatriptan/Placebo|Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg /Placebo = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969284|NCT00899379|P3|Participant Flow|Rizatriptan/Rizatriptan/Placebo/Rizatriptan|Rizatriptan 10 mg/Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969285|NCT00899379|P2|Participant Flow|Rizatriptan/Placebo/Rizatriptan/Rizatriptan|Rizatriptan 10 mg/Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969286|NCT00899379|P1|Participant Flow|Placebo/Rizatriptan/Rizatriptan/Rizatriptan|Placebo/Rizatriptan 10 mg/Rizatriptan 10 mg/Rizatriptan 10 mg = sequence for single dose of study drug taken orally for each recurrence or new migraine (up to 4 headaches)
969287|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
969288|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
969289|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
969290|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
969291|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
969292|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
969293|NCT00899379|O2|Outcome|Placebo|All Placebo patients from all Treatment Sequences
969294|NCT00899379|O1|Outcome|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
969295|NCT00899379|E2|Reported Event|Placebo|All Placebo patients from all Treatment Sequences
969296|NCT00899379|E1|Reported Event|Rizatriptan 10 mg|All Rizatriptan 10 mg patients from all Treatment Sequences
969297|NCT00900666|B3|Baseline|Total|Total of all reporting groups
969298|NCT00900666|B2|Baseline|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
969299|NCT00900666|B1|Baseline|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
969300|NCT00900666|P2|Participant Flow|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
969301|NCT00900666|P1|Participant Flow|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
969302|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
969303|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
969304|NCT00900666|O2|Outcome|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
969344|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
969305|NCT00900666|O1|Outcome|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
969306|NCT00900666|E2|Reported Event|Saline Injection to Rectus Femoris|placebo : A total of 2 cc sterile normal saline: will be injected in 0.5 cc aliquots into 4 different injectate sites within the rectus femoris (with EMG guidance) of the involved limb.
969347|NCT00900237|E1|Reported Event|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
969307|NCT00900666|E1|Reported Event|Botulinum Toxin Injection to Rectus Femoris|botulinum toxin A (BTX-A) : 200 Units BTX-A reconstituted with 2 cc sterile normal saline in 100:1 ratio. Teflon-coated EMG guidance for confirmation of injection into the Rectus femoris muscle in addition to utilizing standardized injection landmarks, the solution will be injected in 0.5 cc aliquots into 4 different injectate sites within the muscle.
969308|NCT00900627|B7|Baseline|Total|Total of all reporting groups
969309|NCT00900627|B6|Baseline|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969310|NCT00900627|B5|Baseline|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969311|NCT00900627|B4|Baseline|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969312|NCT00900627|B3|Baseline|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969313|NCT00900627|B2|Baseline|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969314|NCT00900627|B1|Baseline|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969315|NCT00900627|P6|Participant Flow|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969316|NCT00900627|P5|Participant Flow|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969317|NCT00900627|P4|Participant Flow|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969318|NCT00900627|P3|Participant Flow|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969319|NCT00900627|P2|Participant Flow|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969320|NCT00900627|P1|Participant Flow|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969321|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969322|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969323|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969324|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969325|NCT00900627|O2|Outcome|Placebo + Paclitaxel|Part B: Placebo (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969326|NCT00900627|O1|Outcome|AZD8931 40MG bd + Paclitaxel|Part B: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969327|NCT00900627|O4|Outcome|AZD8931 40 mg bd|Part A: AZD8931 40mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969328|NCT00900627|O3|Outcome|AZD8931 80 mg bd|Part A: AZD8931 80mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969329|NCT00900627|O2|Outcome|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969330|NCT00900627|O1|Outcome|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969331|NCT00900627|E6|Reported Event|Placebo + Paclitaxel|
969332|NCT00900627|E5|Reported Event|AZD8931 40MG bd + Paclitaxel|
969333|NCT00900627|E4|Reported Event|AZD8931 160 mg bd|Part A: AZD8931 160mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969334|NCT00900627|E3|Reported Event|AZD8931 120 mg bd|Part A: AZD8931 120mg (bd) plus weekly paclitaxel of 90mg/m2 on days 1, 8 and 15 of each 28 day cycle
969335|NCT00900627|E2|Reported Event|AZD8931 80 mg bd|
969336|NCT00900627|E1|Reported Event|AZD8931 40 mg bd|
969337|NCT00900237|B3|Baseline|Total|Total of all reporting groups
969338|NCT00900237|B2|Baseline|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
969339|NCT00900237|B1|Baseline|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
969340|NCT00900237|P2|Participant Flow|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
969341|NCT00900237|P1|Participant Flow|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
969342|NCT00900237|O2|Outcome|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
969343|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
970481|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
969345|NCT00900237|O1|Outcome|Eslicarbazepine Acetate|"Eslicarbazepine acetate (ESL) 600 mg QD morning from Day 1-3 and 1200 mg ESL QD morning from Day 4-9~Eslicarbazepine acetate: Oral administration 600 mg QD morning from Day 1-3 and 1200 mg from Day 4-9"
969346|NCT00900237|E2|Reported Event|Oxcarbazepine|"Oxcarbazepine 300 mg BID from Day 1-3 and oxcarbazepine 600mg BID from Day 4-9~Oxcarbazepine: Oxcarbazepine 300 mg BID from Day 1-3 (morning and evening) and oxcarbazepine 600mg BID from Day 4-9 (morning and evening, only morning dose on Day 9)"
969348|NCT00900146|B6|Baseline|Total|Total of all reporting groups
969349|NCT00900146|B5|Baseline|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969350|NCT00900146|B4|Baseline|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969351|NCT00900146|B3|Baseline|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969352|NCT00900146|B2|Baseline|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969353|NCT00900146|B1|Baseline|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969354|NCT00900146|P5|Participant Flow|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969355|NCT00900146|P4|Participant Flow|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969356|NCT00900146|P3|Participant Flow|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969357|NCT00900146|P2|Participant Flow|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969558|NCT00899353|O11|Outcome|Fold Change in ALC-Patient 11|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969358|NCT00900146|P1|Participant Flow|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969469|NCT00900029|B6|Baseline|Total|Total of all reporting groups
969359|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969360|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969361|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969362|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969363|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969364|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969365|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969366|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969367|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969559|NCT00899353|O10|Outcome|Fold Change in ALC-Patient 10|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969560|NCT00899353|O9|Outcome|Fold Change in ALC-Patient 9|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969368|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969369|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969370|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969371|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969372|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969373|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969374|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969375|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969376|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969377|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969561|NCT00899353|O8|Outcome|Fold Change in ALC-Patient 8|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969562|NCT00899353|O7|Outcome|Fold Change in ALC-Patient 7|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969378|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969379|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969380|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969381|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969382|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969383|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969384|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969385|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969386|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969387|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969563|NCT00899353|O6|Outcome|Fold Change in ALC-Patient 6|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969564|NCT00899353|O5|Outcome|Fold Change in ALC-Patient 5|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969388|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969389|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969390|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969391|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969392|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969393|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969394|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969395|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969396|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969397|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969565|NCT00899353|O4|Outcome|Fold Change in ALC-Patient 4|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969566|NCT00899353|O3|Outcome|Fold Change in ALC-Patient 3|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969398|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969399|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969400|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969401|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969402|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969403|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969404|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969405|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969406|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969407|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969567|NCT00899353|O2|Outcome|Fold Change in ALC-Patient 2|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969568|NCT00899353|O1|Outcome|Fold Change in ALC-Patient 1|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969408|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969409|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969410|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969411|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969412|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969413|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969414|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969415|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969416|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969417|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969569|NCT00899353|O5|Outcome|Nuclear Factor Kappa B Activation Post Supplement|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following discontinued consumption of omega 3.
969418|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969419|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969420|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969421|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969422|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969423|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969424|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969425|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969426|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969427|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969611|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
969612|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
969428|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969429|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969430|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969431|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969432|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969433|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969434|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969435|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969436|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969437|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969613|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969614|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969438|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969439|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969440|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969441|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969442|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969443|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969444|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969445|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969446|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969447|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969615|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
969616|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
969448|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969449|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969450|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969451|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969452|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969453|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969454|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969455|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969456|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969457|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969617|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969618|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969458|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969459|NCT00900146|O5|Outcome|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969460|NCT00900146|O4|Outcome|Canakinumab 150 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969461|NCT00900146|O3|Outcome|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969462|NCT00900146|O2|Outcome|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969463|NCT00900146|O1|Outcome|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969464|NCT00900146|E5|Reported Event|Placebo + Metformin|In 4 month dose finding period as well as during intermediate period, patients received one injection of canakinumab matching placebo monthly and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations).
969465|NCT00900146|E4|Reported Event|Canakinumab 150 mg + Metformin|"Experimental: Canakinumab 150 mg + Metformin In 4-Month Dose-finding period, patients visited the clinic monthly and had 150 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969466|NCT00900146|E3|Reported Event|Canakinumab 50 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 50 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969467|NCT00900146|E2|Reported Event|Canakinumab 15 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 15 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969619|NCT00898677|E4|Reported Event|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
970482|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
969468|NCT00900146|E1|Reported Event|Canakinumab 5 mg + Metformin|"In 4-Month Dose-finding period, patients visited the clinic monthly and had 5 mg Canakinumab injected in the clinic at each visit and continued on a stable dose of metformin ≥ 1000 mg daily (or lower dose if required by local regulations). During this period, patients with consecutive morning fasting glucose >200 mg/dL were treated with a daily injection of insulin glargine as add-on therapy.~The intermediate period began after patients completed their 4-month visit and lasted until the primary analysis was completed and the optimal dose was selected. Patients continued on their randomized treatment and made brief visits to the clinic every month. From this point onward, patients with consecutive HbA1c >7.5% were treated with a daily injection of insulin glargine as add-on therapy."
969472|NCT00900029|B3|Baseline|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
969473|NCT00900029|B2|Baseline|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
969474|NCT00900029|B1|Baseline|HP802-247 Vehicle|
969475|NCT00900029|P5|Participant Flow|HP802-247 Vehicle|
969476|NCT00900029|P4|Participant Flow|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
969477|NCT00900029|P3|Participant Flow|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
969478|NCT00900029|P2|Participant Flow|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
969479|NCT00900029|P1|Participant Flow|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
969480|NCT00900029|O5|Outcome|HP802-247 Vehicle|
969481|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
969482|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
969483|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
969484|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
969485|NCT00900029|O5|Outcome|HP802-247 Vehicle|
969486|NCT00900029|O4|Outcome|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
969487|NCT00900029|O3|Outcome|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
969488|NCT00900029|O2|Outcome|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
969489|NCT00900029|O1|Outcome|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
969490|NCT00900029|E5|Reported Event|HP802-247 Vehicle|
969491|NCT00900029|E4|Reported Event|HD-Q7D|HD-Q7D: 5.0 x 106 cell/mL applied to wound surface every week
969492|NCT00900029|E3|Reported Event|HD-Q14D|HD-Q14D: 5.0 x 106 cell/mL applied to wound surface every 2 weeks
969493|NCT00900029|E2|Reported Event|LD-Q7D|LD-Q7D: 0.5 x 106 cell/mL applied to wound surface every week
969494|NCT00900029|E1|Reported Event|LD-Q14D|LD-Q14D: 0.5 x 106 cell/mL applied to wound surface every 2 weeks
969495|NCT00899717|B3|Baseline|Total|Total of all reporting groups
969496|NCT00899717|B2|Baseline|Sham Occlusal Adjustment|
969497|NCT00899717|B1|Baseline|Real Occlusal Adjustment|
969498|NCT00899717|P2|Participant Flow|Sham Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
969499|NCT00899717|P1|Participant Flow|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
969500|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Placebo occlusal adjustment : Simulated modification of occlusal surfaces
969501|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Occlusal adjustment : modification of occlusal surfaces
969502|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
969503|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
969504|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|Number of patients who changed their habitual chewing side
969505|NCT00899717|O1|Outcome|Real Occlusal Adjustment|Number of patients who changed their habitual chewing side
969506|NCT00899717|O2|Outcome|Placebo|
969507|NCT00899717|O1|Outcome|Real|
969508|NCT00899717|O2|Outcome|Placebo Occlusal Adjustment|
969509|NCT00899717|O1|Outcome|Real Occlusal Adjustment|
969510|NCT00899717|E2|Reported Event|Sham Occlusal Adjustment|
969511|NCT00899717|E1|Reported Event|Real Occlusal Adjustment|
969512|NCT00899678|B4|Baseline|Total|Total of all reporting groups
969513|NCT00899678|B3|Baseline|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969514|NCT00899678|B2|Baseline|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969515|NCT00899678|B1|Baseline|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
969516|NCT00899678|P3|Participant Flow|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969620|NCT00898677|E3|Reported Event|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
969517|NCT00899678|P2|Participant Flow|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969518|NCT00899678|P1|Participant Flow|Induction Only|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
969661|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
969519|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969520|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969521|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969522|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969523|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969524|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969525|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969526|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969527|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969528|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969529|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969530|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969531|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969532|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969621|NCT00898677|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969622|NCT00898677|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969533|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969534|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
1025148|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
969535|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969536|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969537|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969538|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969539|NCT00899678|O2|Outcome|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969540|NCT00899678|O1|Outcome|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969541|NCT00899678|E4|Reported Event|Overall Study|Overall Study comprises Induction Period and Maintenance Period (Week -6 to Week 62).
969542|NCT00899678|E3|Reported Event|Maintenance High-Dose|"Maintenance High-Dose group*: 400 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 200 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969543|NCT00899678|E2|Reported Event|Maintenance Low-Dose|"Maintenance Low-Dose group*: 200 mg Certolizumab Pegol once every 4 weeks for subjects ≥ 40 kg or 100 mg Certolizumab Pegol once every 4 weeks for subjects 20 to < 40 kg~*prior to this dosing regimen, subjects underwent an induction of Certolizumab Pegol administered subcutaneously every 2 weeks (total 3 injections) at of either 400 mg for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg"
969544|NCT00899678|E1|Reported Event|Induction Period|"Induction Only is the period between the Week 0 dose and prior to first maintenance dose (Week 8). Induction Only includes all subjects who received a dose during the Induction Period but did not receive any treatment during the Maintenance Period. During the Induction Period (Weeks 0 to 6), subjects were administered Certolizumab Pegol (CZP) subcutaneously every 2 weeks (Q2W) (for a total of 3 administrations of drug) at a dose of either:~400 mg for subjects ≥ 40 kg~200 mg for subjects 20 to < 40 kg"
969545|NCT00899600|B3|Baseline|Total|Total of all reporting groups
969546|NCT00899600|B2|Baseline|Ketamine|
969547|NCT00899600|B1|Baseline|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
969548|NCT00899600|P2|Participant Flow|Ketamine|
969549|NCT00899600|P1|Participant Flow|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
969550|NCT00899600|O2|Outcome|Ketamine|Ketamine 0.5 mg/kg on induction and an infusion at 10mcg/kg/min until wound closure.
969551|NCT00899600|O1|Outcome|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
969552|NCT00899600|E2|Reported Event|Ketamine|
969553|NCT00899600|E1|Reported Event|Normal Saline|Normal saline : Normal saline at same rate as the previously described ketamine infusion (10mcg/kg/min), same amount of ketamine/placebo syringe on induction (0.5mg/kg).
969554|NCT00899353|B1|Baseline|Omega 3 Supplementation|
969555|NCT00899353|P1|Participant Flow|Omega 3 Supplementation|Baseline blood specimens were obtained. All participants were then assigned to consume three, 1250mg omega 3 supplement capsules per day (providing 2.4g of omega 3 total) for one month, the first period. Blood was obtained and participants were assigned to consume six, 1250mg capsules of omega 3 per day (providing 4.8g of omega 3)for one month, the second period. Blood was again obtained and participants were assigned to consume 9 capsules of omega 3 per day, providing 7.2g of omega 3,the third period.
969556|NCT00899353|O13|Outcome|Fold Change in ALC-Patient 14|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969557|NCT00899353|O12|Outcome|Fold Change in ALC-Patient 13|Fold change in ALC after omega-3 consumption as compared to baseline ALC.
969570|NCT00899353|O4|Outcome|Nuclear Factor Kappa B Activation Following 9 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 9 capsules per day (7.2 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
969571|NCT00899353|O3|Outcome|Nuclear Factor Kappa B Activation Following 6 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 6 capsules per day (4.8 g of omega 3 per day).Each 1250mg capsule provided 800mg of omega 3.
969662|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
1025149|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
969572|NCT00899353|O2|Outcome|Nuclear Factor Kappa B Activation Following 3 Capsules Per Day|Nuclear factor Kappa B (NFkB)activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia following consumption of 3 capsules per day (2.4 g of omega 3 per day). Each 1250mg capsule provided 800mg of omega 3.
969573|NCT00899353|O1|Outcome|Baseline Nuclear Factor Kappa B Activation|Baseline nuclear factor Kappa B (NFkB) activation in isolated lymphocytes from patients with early stage chronic lymphocytic leukemia.
969574|NCT00899353|E1|Reported Event|Adverse Effects|Serious adverse effects associated with omega 3 fatty acid consumption.
969575|NCT00898807|B3|Baseline|Total|Total of all reporting groups
969576|NCT00898807|B2|Baseline|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
969577|NCT00898807|B1|Baseline|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
969578|NCT00898807|P2|Participant Flow|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
969579|NCT00898807|P1|Participant Flow|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
969580|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
969581|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
969582|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
969583|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
969584|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
969585|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
969586|NCT00898807|O2|Outcome|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
969587|NCT00898807|O1|Outcome|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
969588|NCT00898807|E2|Reported Event|Placebo and Psychosocial Intervention|"Matching placebo, oral, and psychosocial intervention~placebo : daily for 9 weeks"
969589|NCT00898807|E1|Reported Event|Citalopram and Psychosocial Intervention|"Target dose of 30 mg per day of citalopram, oral, and psychosocial intervention~citalopram : target dose 30mg daily for 9 weeks"
969590|NCT00898677|B5|Baseline|Total|Total of all reporting groups
969591|NCT00898677|B4|Baseline|Placebo|"Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
969592|NCT00898677|B3|Baseline|Sumatriptan 100 mg|"Sumatriptan 100 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
969593|NCT00898677|B2|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg orally once for treatment of single migraine attack~Baseline measure Participants reported are those participants that recieved study treatment."
969594|NCT00898677|B1|Baseline|Rizatriptan 5 mg|"Rizatriptan 5 mg orally once for treatment of single migraine attack.~Baseline measure Participants reported are those participants that recieved study treatment."
969595|NCT00898677|P4|Participant Flow|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
969596|NCT00898677|P3|Participant Flow|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
969597|NCT00898677|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969598|NCT00898677|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969599|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
969600|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
969601|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969602|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969603|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
969604|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
969605|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969606|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969607|NCT00898677|O4|Outcome|Placebo|Placebo matching Rizatriptan and Sumatriptan orally once for treatment of single migraine attack
969608|NCT00898677|O3|Outcome|Sumatriptan 100 mg|Sumatriptan 100 mg orally once for treatment of single migraine attack
969609|NCT00898677|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969610|NCT00898677|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
977436|NCT00874939|B1|Baseline|All Participants|All enrolled participants
969623|NCT00898560|B1|Baseline|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
969663|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969624|NCT00898560|P1|Participant Flow|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
969625|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
969626|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
969627|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
969628|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
969629|NCT00898560|O2|Outcome|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
969630|NCT00898560|O1|Outcome|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
969631|NCT00898560|E2|Reported Event|Microginon®|"A single oral dose of a combined oral contraceptive containing 30ug ethinyloestradiol and 150ug levonorgestrel (Microginon ®).~Microginon®: Single oral dose of Microginon® (30ug ethinyloestradiol and 150ug levonorgestrel)"
969632|NCT00898560|E1|Reported Event|ESL and Microginon®|"15-day treatment with ESL 800 mg once daily, with co administration of a single oral dose of Microginin® on Day 14 of the relevant dosing period, to assess impact of ESL on pharmacokinetics of the combined oral contraceptive.~eslicarbazepine acetate and Microginon®: eslicarbazepine acetate: once-daily oral dose of 800 mg on days 1- 15 of treatment period.~Microginon®: single oral dose on day 14 of treatment period"
969633|NCT00898443|B3|Baseline|Total|Total of all reporting groups
969634|NCT00898443|B2|Baseline|Epidural Anesthetic Group|This is the experimental group for this study.
969635|NCT00898443|B1|Baseline|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
969636|NCT00898443|P2|Participant Flow|Epidural Anesthetic Group|This is the experimental group for this study.
969637|NCT00898443|P1|Participant Flow|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
969638|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
969639|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
969640|NCT00898443|O2|Outcome|Epidural Anesthetic Group|This is the experimental group for this study.
969641|NCT00898443|O1|Outcome|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
969642|NCT00898443|E2|Reported Event|Epidural Anesthetic Group|This is the experimental group for this study.
969643|NCT00898443|E1|Reported Event|Spinal Anesthetic Group|This group will receive spinal anesthetic for the surgical procedure and will serve as the control group for this study.
969644|NCT00898222|B1|Baseline|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
969645|NCT00898222|P1|Participant Flow|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
969646|NCT00898222|O1|Outcome|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
969647|NCT00898222|E1|Reported Event|Aspirin|"Low dose daily aspirin in healthy volunteers for two weeks~aspirin : 81 mg orally daily for two weeks"
969648|NCT00897949|B4|Baseline|Total|Total of all reporting groups
969649|NCT00897949|B3|Baseline|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
969650|NCT00897949|B2|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969651|NCT00897949|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969652|NCT00897949|P3|Participant Flow|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
969653|NCT00897949|P2|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969654|NCT00897949|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969655|NCT00897949|O6|Outcome|Placebo / Rizatriptan 10 mg|Placebo initially, prerandomized to rizatriptan 10 mg
969656|NCT00897949|O5|Outcome|Placebo / Rizatriptan 5 mg|Placebo initially, prerandomized to rizatriptan 5 mg
969657|NCT00897949|O4|Outcome|Rizatriptan 10 mg / Placebo|Rizatriptan 10 mg initially, prerandomized to placebo
969658|NCT00897949|O3|Outcome|Rizatriptan 10 mg / Rizatriptan 10 mg|Rizatriptan 10 mg initially, prerandomized to rizatriptan 10 mg
969659|NCT00897949|O2|Outcome|Rizatriptan 5 mg / Placebo|Rizatriptan 5 mg initially, prerandomized to placebo
969660|NCT00897949|O1|Outcome|Rizatriptan 5 mg / Rizatriptan 5 mg|Rizatriptan 5 mg initially, prerandomized to rizatriptan 5 mg
969664|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
969665|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969666|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969667|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
969668|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969669|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969670|NCT00897949|O3|Outcome|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
969671|NCT00897949|O2|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969672|NCT00897949|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969673|NCT00897949|E3|Reported Event|Placebo|Placebo matching Rizatiptan 5 mg and Rizatriptan 10 mg orally once for treatment
969674|NCT00897949|E2|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of single migraine attack
969675|NCT00897949|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969676|NCT00897910|B1|Baseline|Collection of Circulating Blood and Bone Marrow.|
969677|NCT00897910|P1|Participant Flow|Collection of Circulating Blood and Bone Marrow.|
969678|NCT00897910|O1|Outcome|Collection of Blood and Bone Marrow.|
969679|NCT00897910|E1|Reported Event|Collection of Circulating Blood and Bone Marrow.|
969680|NCT00897897|B1|Baseline|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
969681|NCT00897897|P1|Participant Flow|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
969682|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
969683|NCT00897897|O1|Outcome|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
969684|NCT00897897|E1|Reported Event|Treated Leiomyomas|"Pre- or peri-menopausal women with symptomatic uterine fibroids who desire a uterine sparing procedure. Patients must have completed child bearing prior to enrolling in this study.~Patients underwent a single Magnetic Resonanc Imaging-guided High Intensity Focused Ultrasound (MR-HIFU) therapy session as an outpatient procedure, and were followed up for 30 days following treatment."
969685|NCT00897715|B3|Baseline|Total|Total of all reporting groups
969686|NCT00897715|B2|Baseline|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
969687|NCT00897715|B1|Baseline|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
969688|NCT00897715|P2|Participant Flow|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
969689|NCT00897715|P1|Participant Flow|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
969690|NCT00897715|O2|Outcome|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
969691|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
969692|NCT00897715|O2|Outcome|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
969693|NCT00897715|O1|Outcome|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
969694|NCT00897715|E2|Reported Event|Placebo|"matching placebo~Placebo: 160 mg of placebo administered subcutaneously once a week for 12 weeks"
969695|NCT00897715|E1|Reported Event|Interleukin-1 Receptor Antagonist|"active drug~Rilonacept: 160 mg of rilonacept administered subcutaneously once a week for 12 weeks"
969696|NCT00897390|B1|Baseline|All Enrolled and Treated Participants|
969697|NCT00897390|P1|Participant Flow|All Treated Participants|Participants were assigned to 1 of 4 treatment sequences (A-D-B-C, B-A-C-D, C-B-D-A, D-C-A-B). Treatment A=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fasted; Treatment B=fixed-dose combination (FDC) tablet of 2.5-mg saxagliptin/1000-mg metformin immediate release (IR), fasted; Treatment C=2.5-mg saxagliptin tablet co-administered with 1000-mg metformin IR tablet, fed; Treatment D=FDC tablet of 2.5-mg saxagliptin/1000-mg metformin IR, fed. The washout between each dose was at least 7 days.
969698|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969699|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969700|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969806|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969701|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969702|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969703|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969704|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969705|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969706|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969707|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969708|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969709|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969710|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969711|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969712|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969713|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969714|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969715|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969716|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969717|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969718|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969719|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969720|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969721|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969722|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969723|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969724|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969725|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969726|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969727|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969728|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969729|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969890|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969730|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969731|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969732|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969733|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969734|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969735|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969736|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969737|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969738|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969739|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969740|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969741|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969742|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969743|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969744|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969745|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969746|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969747|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969748|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969749|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969750|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969751|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969752|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969753|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969754|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969755|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969756|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969757|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969758|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969759|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969760|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969761|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969891|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969762|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969763|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969764|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969765|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969766|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969767|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969768|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969769|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969770|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969771|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969772|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969773|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969774|NCT00897390|O4|Outcome|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal
969775|NCT00897390|O3|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal
969776|NCT00897390|O2|Outcome|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a fixed dose combination (FDC) tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969777|NCT00897390|O1|Outcome|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions
969778|NCT00897390|E5|Reported Event|Not Dosed|58 participants were enrolled in the study; 34 participants were not dosed (23 no longer met study criteria, 4 withdrew consent, and 7 for other reasons).
969779|NCT00897390|E4|Reported Event|FDC Tablet of 2.5-mg Saxa/1000-mg Met Tablet, Fed|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fed conditions with a standard meal.
969780|NCT00897390|E3|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fed|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fed conditions with a standard meal.
969781|NCT00897390|E2|Reported Event|FDC Tablet 2.5-mg Saxa/1000-mg Met Tablet, Fasted|Single oral dose of a FDC tablet consisting of 2.5 mg saxagliptin/ 1000 mg metformin IR under fasted conditions
969782|NCT00897390|E1|Reported Event|2.5-mg Saxa Tablet/1000-mg Met Tablet, Fasted|Co-administration of single oral doses of a 2.5 mg tablet of saxagliptin and a 1000 mg tablet of metformin IR under fasted conditions.
969783|NCT00897104|B4|Baseline|Total|Total of all reporting groups
969784|NCT00897104|B3|Baseline|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969785|NCT00897104|B2|Baseline|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969786|NCT00897104|B1|Baseline|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969787|NCT00897104|P3|Participant Flow|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969788|NCT00897104|P2|Participant Flow|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969789|NCT00897104|P1|Participant Flow|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969790|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969791|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969792|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969793|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969794|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969795|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969796|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969797|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969798|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969799|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969800|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969801|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969802|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969803|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969804|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969805|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
1025150|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
969807|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969808|NCT00897104|O3|Outcome|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969809|NCT00897104|O2|Outcome|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969810|NCT00897104|O1|Outcome|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969811|NCT00897104|E3|Reported Event|Placebo|Placebo matching Rizatriptan 5 mg or Sumatriptan 5 mg orally once for treatment of single migraine attack
969812|NCT00897104|E2|Reported Event|Sumatriptan 5 mg|Sumatriptan 5 mg orally once for treatment of single migraine attack
969813|NCT00897104|E1|Reported Event|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of single migraine attack
969814|NCT00896779|B3|Baseline|Total|Total of all reporting groups
969815|NCT00896779|B2|Baseline|Ranibizumab Group 2|Group 2: 6 monthly injecions of 0.5mg then prn
969816|NCT00896779|B1|Baseline|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
969817|NCT00896779|P2|Participant Flow|Ranibizumab Group 2|Group 1: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
969818|NCT00896779|P1|Participant Flow|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
969819|NCT00896779|O2|Outcome|Ranibizumab Group 2|Group 2: 6 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
969820|NCT00896779|O1|Outcome|Ranibizumab Group 1|Group 1: 3 monthly injections of raibizumab 0.5mg then injections as needed for 12 months
969821|NCT00896779|E2|Reported Event|Ranibizumab Group 2|Group 2: 6 monthly injections of 0.5 mg then prn
969822|NCT00896779|E1|Reported Event|Ranibizumab Group 1|Group 1: 3 monthly injections of 0.5mg then prn
969823|NCT00896649|B1|Baseline|Positron Emission Mammography (PEM), Mammography, Questionaire|"questionnaire administration digital mammography positron emission mammography~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~digital mammography: standard screening mammogram~positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
969824|NCT00896649|P1|Participant Flow|Single Arm Positron Emission Mamm, Mammogram and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
969825|NCT00896649|O1|Outcome|Single Arm Positron Emission Mammo, Mammogram & Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
969826|NCT00896649|O1|Outcome|Single Arm Positron Emission Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with positron emission mammography experience.~positron emission mammography: one-time positron emission mammography to compare recall rates with that of standard mammogram"
969827|NCT00896649|E1|Reported Event|Single Arm PEM, Mammography and Questionnaire|"questionnaire administration positron emission mammography~digital mammography: standard screening mammogram~questionnaire administration: Questionnaire regarding patient satisfaction with mammogram experience and with PEM experience.~positron emission mammography: one-time PEM to compare recall rates with that of standard mammogram"
969828|NCT00896454|B1|Baseline|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969829|NCT00896454|P1|Participant Flow|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969830|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969831|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969832|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969833|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969834|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969835|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969836|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969837|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969838|NCT00896454|O1|Outcome|Denosumab|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
980280|NCT00865306|E2|Reported Event|No Intervention (Wait-list Controls)|
969839|NCT00896454|E1|Reported Event|Denosumab 120 mg Q4W|Participants received denosumab at a dose of 120 mg subcutaneously (SC) every 4 weeks (Q4W) with a loading dose of 120 mg SC on study Days 8 and 15.
969840|NCT00896337|B1|Baseline|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
969841|NCT00896337|P1|Participant Flow|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
969842|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969843|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969844|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969845|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969846|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969847|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969848|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969849|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969850|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969851|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969852|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969853|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969854|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969855|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969856|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969857|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969858|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969859|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969860|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969861|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969862|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969863|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969864|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969865|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969866|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969867|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969868|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969869|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969870|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969871|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969872|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969873|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969874|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969875|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
969876|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent
969877|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
969878|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
969879|NCT00896337|O1|Outcome|Epic Stent|Participants who received the Epic Stent during the index procedure.
969880|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969881|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969882|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969883|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969884|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969885|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969886|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969887|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969888|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
969889|NCT00896337|O1|Outcome|Epis Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System
980281|NCT00865306|E1|Reported Event|Active CBT|
969892|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969893|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969894|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969895|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
1025151|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
969896|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969897|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969898|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969899|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969900|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969901|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969902|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969903|NCT00896337|O1|Outcome|Epic Stent|Subjects treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969904|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969905|NCT00896337|O1|Outcome|Epic Stent|Participants treated with iliac artery stenting using the Epic™ Nitinol Stent System.
969906|NCT00896337|E1|Reported Event|ORION|All subjects who meet the inclusion criteria and are enrolled in this trial will be treated with iliac artery stenting with the Epic™ Nitinol Stent System.
969907|NCT00896233|B1|Baseline|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
969908|NCT00896233|P1|Participant Flow|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
969909|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
969910|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
969911|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
969912|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
969913|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
969914|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
969915|NCT00896233|O2|Outcome|Reader 2|Participant scans evaluated by Reader 2.
969916|NCT00896233|O1|Outcome|Reader 1|Participant scans evaluated by Reader 1.
969917|NCT00896233|E1|Reported Event|Magnetic Resonance Elastography (MRE)|In Part 1 of the study, participants had a screening visit, followed ~1 month later by two imaging visits over ~14 days. Each imaging visit consisted of two liver MRE scans.
969918|NCT00896168|B3|Baseline|Total|Total of all reporting groups
969919|NCT00896168|B2|Baseline|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969920|NCT00896168|B1|Baseline|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969921|NCT00896168|P2|Participant Flow|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969922|NCT00896168|P1|Participant Flow|Infliximab + Methotrexate (Moderate Rheumatoid Arthritis [RA])|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the disease activitiy score [DAS] 28) received infliximab 3 milligram per kilogram (mg/kg) intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969923|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969924|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969925|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969926|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969927|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969928|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
970024|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
969929|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969930|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969931|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969932|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969933|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969934|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969935|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969936|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969937|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969938|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969939|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969940|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969941|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969942|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969943|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969944|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969945|NCT00896168|O2|Outcome|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
969946|NCT00896168|O1|Outcome|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969947|NCT00896168|E2|Reported Event|Infliximab + Methotrexate (Severe RA)|Participants with severe RA (score greater than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week equal to the dose used before participation in the study) for 22 weeks.
970497|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
969948|NCT00896168|E1|Reported Event|Infliximab + Methotrexate (Moderate RA)|Participants with moderate RA (score greater than 3.2, but less than 5.1 on the DAS 28) received infliximab 3 mg/kg intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) at Week 0, 2, 6, 14 and 22 along with oral MTX in a stable dose of 7.5 to 20 mg per week (equal to the dose used before participation in the study) for 22 weeks.
969949|NCT00896051|B3|Baseline|Total|Total of all reporting groups
969950|NCT00896051|B2|Baseline|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
969951|NCT00896051|B1|Baseline|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
969952|NCT00896051|P2|Participant Flow|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
969953|NCT00896051|P1|Participant Flow|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
969954|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969955|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
969956|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969957|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
969958|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969959|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
969960|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969961|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
969962|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969963|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
969964|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969965|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
970019|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
969966|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969967|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced HIV-1 infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
969968|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment B).
969969|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 2 weeks (Pre-treatment Period) followed by ATV/rtv 300/100 mg once daily + etravine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks (Treatment A).
969970|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
969971|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
969972|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
969973|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI).
969974|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
969975|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
969976|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for rtv provided in the table below are at Week 2.
969977|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
969978|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
969979|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
969980|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
969981|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
969982|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
969983|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
970020|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970021|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
969984|NCT00896051|O2|Outcome|ATV/Rtv 400/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/ritonavir (rtv) 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
969985|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
969986|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
969987|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
969988|NCT00896051|O2|Outcome|ATV/Rtv 300/100 mg (Test)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 nucleoside reverse transcriptase inhibitor (NRTI) for 48 weeks during the treatment period (Day 1 to Week 48). Pharmacokinetic results for ATV provided in the table below are at Week 2.
969989|NCT00896051|O1|Outcome|ATV/Rtv 300/100 mg (Reference)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for 14 days during the pre-treatment period. Pharmacokinetic results for ATV provided in the table below are at Day -1.
969990|NCT00896051|E2|Reported Event|ATV/Rtv 400/100 mg (Treatment B)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) pretreatment for 2 weeks followed by ATV/rtv 400/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
969991|NCT00896051|E1|Reported Event|ATV/Rtv 300/100 mg (Treatment A)|Treatment-experienced human immunodeficiency virus – type 1 (HIV-1) infected participants took by mouth atazanavir (ATV)/low-dose ritonavir (rtv) 300/100 mg once daily + 2 nucleoside reverse transcriptase inhibitors (NRTIs) for pre-treatment for 2 weeks followed by ATV/rtv 300/100 mg once daily + etravirine (ETR) 200 mg twice daily + 1 NRTI for 48 weeks.
969992|NCT00896038|B3|Baseline|Total|Total of all reporting groups
969993|NCT00896038|B2|Baseline|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
969994|NCT00896038|B1|Baseline|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
969995|NCT00896038|P2|Participant Flow|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
969996|NCT00896038|P1|Participant Flow|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
969997|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
969998|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
969999|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970000|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970001|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970002|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970003|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970004|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970005|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970006|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970007|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970008|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970009|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970010|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970011|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970012|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970013|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970014|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970015|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970016|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970017|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970018|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
980282|NCT00865202|B3|Baseline|Total|Total of all reporting groups
970022|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970023|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970498|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970025|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970026|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970027|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970028|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970029|NCT00896038|O2|Outcome|Placebo|Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
970030|NCT00896038|O1|Outcome|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970031|NCT00896038|E2|Reported Event|Placebo|Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
970032|NCT00896038|E1|Reported Event|Aprepitant|Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
970033|NCT00896025|B1|Baseline|N-acetycylcysteine|Each eligible Acute Liver Failure patient will be given N-acetylcysteine (NAC), beginning at a dose of 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour, followed by 50 mg/kg in 500 ml 5% dextrose over four hours, and 125 mg/kg in 1000 ml 5% dextrose over 19 hours, then 150 mg/kg in 1000 ml 5% dextrose per 24 hours for an additional 48 hours. The patient will be on continuous NAC infusion for a total of 72 hours.
970034|NCT00896025|P1|Participant Flow|N-acetycylcysteine|Acute liver failure population
970035|NCT00896025|O1|Outcome|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
970036|NCT00896025|E1|Reported Event|N-acetycylcysteine|"Acute liver failure population~N-acetylcysteine: Patients will be included in the trial from the onset of any hepatic coma grade and will receive NAC for the following 72 hrs.~NAC Solutions: The N-acetylcysteine will be added to 5% dextrose in defined concentrations according to the sequence of four specific doses required for the study.~i.Solution A: 150 mg/kg bodyweight in 250 ml 5% dextrose over one hour~ii.Solution B: 50 mg/kg in 500 ml 5% dextrose over four hours~iii.Solution C: 125 mg/kg in 1000 ml 5% dextrose over 19 hours~iv.Solution D: 150 mg/kg in 1000 ml 5% dextrose per 24 hours~v.Solution E: 150 mg/kg in 1000 ml 5% dextrose per 24 hours"
970037|NCT00895947|B3|Baseline|Total|Total of all reporting groups
970038|NCT00895947|B2|Baseline|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970039|NCT00895947|B1|Baseline|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970040|NCT00895947|P2|Participant Flow|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970041|NCT00895947|P1|Participant Flow|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970042|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970043|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970044|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970045|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970046|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970047|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970048|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970049|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970050|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970051|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970052|NCT00895947|O2|Outcome|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970053|NCT00895947|O1|Outcome|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970054|NCT00895947|E2|Reported Event|Placebo|200 mg anhydrous crystalline maltose given once daily for 16 weeks in an orally disolving lozenge
970055|NCT00895947|E1|Reported Event|Interferon-alpha|150 international units of interferon-alpha given once daily for 16 weeks in an orally disolving lozenge consisting of 200 mg of anhydrous crystalline maltose
970056|NCT00895934|B3|Baseline|Total|Total of all reporting groups
970057|NCT00895934|B2|Baseline|Phase 2/Selected Dose|Azacitidine 75 mg/m2 SC or IV on days 1-7, vorinostat 400 mg qd po on days 1-9, gemtuzumab ozogamicin 3 mg/m2 IV on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
970058|NCT00895934|B1|Baseline|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
970059|NCT00895934|P2|Participant Flow|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
970060|NCT00895934|P1|Participant Flow|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat orally on days 1-9, azacitidine subcutaneously (SC) or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
970061|NCT00895934|O2|Outcome|Phase 2/Selected Dose|Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.
970062|NCT00895934|O1|Outcome|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~gemtuzumab ozogamicin: Given IV~azacitidine: Given IV or SC~laboratory biomarker analysis: Correlative studies"
970063|NCT00895934|E2|Reported Event|Phase 2/Selected Dose|"Azacitidine 75 mg/m2 on days 1-7, vorinostat 400 mg qd on days 1-9, gemtuzumab ozogamicin 3 mg/m2 on days 4 and 8. Includes cohort 4 from the Phase 1 portion of the study.~Laboratory biomarker analysis: correlative studies"
970064|NCT00895934|E1|Reported Event|Phase 1 Dose-Finding Cohorts 1-3|"Patients receive vorinostat PO on days 1-9, azacitidine SC or IV over 10-40 minutes on days 1-7, and gemtuzumab ozogamicin IV over 2 hours on day 8. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: correlative studies"
970065|NCT00895895|B6|Baseline|Total|Total of all reporting groups
970066|NCT00895895|B5|Baseline|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970067|NCT00895895|B4|Baseline|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970068|NCT00895895|B3|Baseline|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970069|NCT00895895|B2|Baseline|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970070|NCT00895895|B1|Baseline|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970071|NCT00895895|P5|Participant Flow|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970072|NCT00895895|P4|Participant Flow|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970073|NCT00895895|P3|Participant Flow|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970074|NCT00895895|P2|Participant Flow|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970075|NCT00895895|P1|Participant Flow|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970076|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970483|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970077|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
1025152|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
970078|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970079|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970080|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970081|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970082|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970083|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970084|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970085|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970086|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970087|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970088|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970089|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970090|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970091|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970092|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970093|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970235|NCT00895752|E1|Reported Event|Riluzole|"Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.~Riluzole: Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day."
970484|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970094|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970095|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970096|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970097|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970098|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970099|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970100|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970101|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970102|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970103|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970104|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970105|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970106|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970107|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970108|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970109|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970110|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
980283|NCT00865202|B2|Baseline|Placebo|similar appearing placebo
970111|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970112|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970113|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970114|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970115|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970116|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970117|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970118|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970119|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970120|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970121|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970122|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970123|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970124|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970125|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970126|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970127|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970236|NCT00895661|B1|Baseline|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
970128|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970129|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970130|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970131|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970132|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970133|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970134|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970135|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970136|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970137|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970138|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970139|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970140|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970141|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970142|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970143|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970144|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970237|NCT00895661|P1|Participant Flow|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
970162|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970145|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970146|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970147|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970148|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970149|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970150|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970151|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970152|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970153|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970154|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970155|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970156|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970157|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970158|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970159|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970160|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970161|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970485|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970163|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970164|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970165|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970166|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970167|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970168|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970169|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970170|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970171|NCT00895895|O5|Outcome|Donepezil|Matching SAM-531 placebo capsule administered orally (QD, morning) for up to 52 weeks. Encapsulated Donepezil 5 mg tablet administered orally (QD, evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970172|NCT00895895|O4|Outcome|SAM-531 (5.0 mg)|SAM-531 5.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970173|NCT00895895|O3|Outcome|SAM-531 (3.0 mg)|SAM-531 3.0 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered orally QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970174|NCT00895895|O2|Outcome|SAM-531 (1.5 mg)|SAM-531 1.5 mg capsule administered orally QD (morning) for up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970175|NCT00895895|O1|Outcome|Placebo, Then SAM-531|Matching SAM-531 placebo capsule administered orally once daily (QD, morning) and matching encapsulated Donepezil placebo tablet QD (evening) for up to 24 weeks (Period 1). Then from Week 25 up to Week 52 (Period 2) participants received SAM-531 5.0 milligram (mg) capsule administered once daily (QD, morning) and matching encapsulated Donepezil placebo tablet administered QD (evening). From Week 7 until Week 52 (end of study), the evening dose in both period 1 and 2 could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970176|NCT00895895|E10|Reported Event|Donepezil Period 2|Matching SAM-531 placebo capsule administered QD (morning dose) for up to 52 weeks. One encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) from Week 25 up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
970177|NCT00895895|E9|Reported Event|SAM-531 5.0 mg Period 2|SAM-531 5.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970178|NCT00895895|E8|Reported Event|SAM-531 3.0 mg Period 2|SAM-531 3.0 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970375|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
970486|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970179|NCT00895895|E7|Reported Event|SAM-531 1.5 mg Period 2|SAM-531 1.5 mg capsule administered QD (morning dose) Week 25 up to 52 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 52 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970180|NCT00895895|E6|Reported Event|SAM-531 5.0 mg Crossover Period 2|Participants who received Placebo in Period 1, beginning in Week 25 and up to Week 52 (Period 2) received SAM-531 5.0 mg capsule administered QD (morning dose) and matching encapsulated Donepezil placebo tablet administered QD (evening dose). The evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970181|NCT00895895|E5|Reported Event|Donepezil Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and 1 encapsulated Donepezil 5 mg tablet administered orally QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion and according to tolerance.
970182|NCT00895895|E4|Reported Event|SAM-531 5.0 mg Period 1|SAM-531 5.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970183|NCT00895895|E3|Reported Event|SAM-531 3.0 mg Period 1|SAM-531 3.0 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970184|NCT00895895|E2|Reported Event|SAM-531 1.5 mg Period 1|SAM-531 1.5 mg capsule administered QD (morning dose) through 24 weeks. Matching encapsulated Donepezil placebo tablet administered QD (evening dose) through 24 weeks. From Week 7 until Week 52 (end of study), the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970185|NCT00895895|E1|Reported Event|Placebo/5.0 mg Period 1|Matching SAM-531 placebo capsule administered QD (morning dose) and one encapsulated Donepezil placebo tablet administered QD (evening dose) for up to 24 weeks (Period 1). From Week 7 the evening dose could have been increased to 2 tablets and adjusted back to 1 tablet at the investigator’s discretion.
970186|NCT00895843|B3|Baseline|Total|Total of all reporting groups
970187|NCT00895843|B2|Baseline|Brufen Retard|
970188|NCT00895843|B1|Baseline|Conventional Ibuprofen|
970189|NCT00895843|P2|Participant Flow|Brufen Retard|
970190|NCT00895843|P1|Participant Flow|Conventional Ibuprofen|
970191|NCT00895843|O2|Outcome|Brufen Retard|
970192|NCT00895843|O1|Outcome|Conventional Ibuprofen|
970193|NCT00895843|E2|Reported Event|Brufen Retard|
970194|NCT00895843|E1|Reported Event|Conventional Ibuprofen|
970195|NCT00895830|B6|Baseline|Total|Total of all reporting groups
970196|NCT00895830|B5|Baseline|APD405 3mg Dose|
970197|NCT00895830|B4|Baseline|APD405 2mg Dose|
970198|NCT00895830|B3|Baseline|APD405 1mg Dose|
970199|NCT00895830|B2|Baseline|APD405 0.3mg Dose|
970200|NCT00895830|B1|Baseline|Placebo|
970201|NCT00895830|P5|Participant Flow|APD405 3mg Dose|
970202|NCT00895830|P4|Participant Flow|APD405 2mg Dose|
970203|NCT00895830|P3|Participant Flow|APD405 1mg Dose|
970204|NCT00895830|P2|Participant Flow|APD405 0.3mg Dose|
970205|NCT00895830|P1|Participant Flow|Placebo|
970206|NCT00895830|O5|Outcome|APD405 3mg Dose|
970207|NCT00895830|O4|Outcome|APD405 2mg Dose|
970208|NCT00895830|O3|Outcome|APD405 1mg Dose|
970209|NCT00895830|O2|Outcome|APD405 0.3mg Dose|
970210|NCT00895830|O1|Outcome|Placebo|
970211|NCT00895830|E5|Reported Event|APD405 3mg Dose|
970212|NCT00895830|E4|Reported Event|APD405 2mg Dose|
970213|NCT00895830|E3|Reported Event|APD405 1mg Dose|
970214|NCT00895830|E2|Reported Event|APD405 0.3mg Dose|
970215|NCT00895830|E1|Reported Event|Placebo|
970216|NCT00895817|B3|Baseline|Total|Total of all reporting groups
970217|NCT00895817|B2|Baseline|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
970218|NCT00895817|B1|Baseline|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
970219|NCT00895817|P2|Participant Flow|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
970220|NCT00895817|P1|Participant Flow|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
970221|NCT00895817|O2|Outcome|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
970222|NCT00895817|O1|Outcome|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
970223|NCT00895817|E2|Reported Event|Swallowed Fluticasone|Swallowed fluticasone : 440 µg twice daily for 8 weeks
970224|NCT00895817|E1|Reported Event|Esomeprazole|Esomeprazole : 40 mg once daily for 8 weeks
970225|NCT00895752|B1|Baseline|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
970226|NCT00895752|P1|Participant Flow|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
970227|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
970228|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
970229|NCT00895752|O1|Outcome|Riluzole|Six week open-label treatment with riluzole, maximum dose of 50 mg twice a day.
970230|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
970231|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
970232|NCT00895752|O1|Outcome|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
970233|NCT00895752|O1|Outcome|Riluzole|6 subjects received open label riluzole, maximum dose of 50mg bid.
970234|NCT00895752|O1|Outcome|Riluzole|Six subjects received 6-weeks of open-label riluzole with maximum dose of 50mg bid.
980844|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
970238|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
970499|NCT00894803|E2|Reported Event|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970239|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
970240|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
970241|NCT00895661|O1|Outcome|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
970242|NCT00895661|E1|Reported Event|Rituximab|"single-arm, open-label, interventional~rituximab: Increased dose (750 mg/m2) intravenously for 4 weekly doses followed by maintenance dosing once every three months for up to 2 years. Maintenance dose is standard (375 mg/m2)."
970243|NCT00895583|B3|Baseline|Total|Total of all reporting groups
970244|NCT00895583|B2|Baseline|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970245|NCT00895583|B1|Baseline|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970246|NCT00895583|P2|Participant Flow|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970247|NCT00895583|P1|Participant Flow|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970248|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970249|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970250|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970376|NCT00895232|E3|Reported Event|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
970377|NCT00895232|E2|Reported Event|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
970378|NCT00895232|E1|Reported Event|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
970388|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970500|NCT00894803|E1|Reported Event|Rt-PA Only|rt-PA (0.9 mg/kg)
970251|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970252|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970253|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970254|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970255|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970256|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970257|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970258|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970259|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970379|NCT00895193|B5|Baseline|Total|Total of all reporting groups
970260|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970261|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970262|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970263|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970264|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970265|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970266|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970267|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970268|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970380|NCT00895193|B4|Baseline|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970381|NCT00895193|B3|Baseline|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970487|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970269|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970270|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970271|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970272|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970273|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970274|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970275|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970276|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970277|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970488|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970278|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970279|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970280|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970281|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970282|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970283|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970284|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970285|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970286|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970382|NCT00895193|B2|Baseline|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970383|NCT00895193|B1|Baseline|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970489|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970287|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970288|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970289|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970290|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970291|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970292|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970293|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970294|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970295|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970490|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970296|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970297|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970298|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970299|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970300|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970301|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970302|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970303|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970304|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970384|NCT00895193|P4|Participant Flow|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970385|NCT00895193|P3|Participant Flow|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970491|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970305|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970306|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970307|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970308|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970309|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970310|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970311|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970312|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970313|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970492|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970314|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970315|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970316|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970317|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970318|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970319|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970320|NCT00895583|O2|Outcome|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970321|NCT00895583|O1|Outcome|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970322|NCT00895583|E2|Reported Event|Tacrolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized and tacrolimus continued. Participants remained on an IMPDH inhibitor (MMF or MPS; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 mg/day of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970386|NCT00895193|P2|Participant Flow|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970387|NCT00895193|P1|Participant Flow|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970493|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970323|NCT00895583|E1|Reported Event|Sirolimus|Participants received tacrolimus (extended-release formulation not permitted) within 30 days of transplant, dosed according to center’s standard of care. At 3-5 months post-transplant, participants were randomized, tacrolimus was discontinued (withdrawal was to be completed within 2 weeks [maximum of 4 weeks] of sirolimus initiation) and participants received sirolimus tablets, orally, at a dose to achieve trough levels of 7-15 nanograms per milliliter (ng/mL) during the first year post-transplant, then 5-15 ng/mL. Participants remained on an inosine monophosphate dehydrogenase (IMPDH) inhibitor (mycophenolate mofetil [MMF] or mycophenolate sodium [MPS]; switching between the two was permitted). Corticosteroids were maintained at a minimum of 2.5 milligrams per day (mg/day) of prednisone (or equivalent); withdrawal was prohibited after randomization. Participants received study drug during the post-randomization period for up to a maximum of 18 months post-transplant.
970324|NCT00895453|B4|Baseline|Total|Total of all reporting groups
970325|NCT00895453|B3|Baseline|Classic Homeopathy|
970326|NCT00895453|B2|Baseline|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
970327|NCT00895453|B1|Baseline|Itraconazole|itraconazole alone
970328|NCT00895453|P3|Participant Flow|Classic Homeopathy|
970329|NCT00895453|P2|Participant Flow|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
970330|NCT00895453|P1|Participant Flow|Itraconazole|itraconazole alone
970331|NCT00895453|O3|Outcome|Classic Homeopathy|
970332|NCT00895453|O2|Outcome|Itraconazole + Lactobacillus Gasseri|itraconazole + local lactobacillus gasseri
970333|NCT00895453|O1|Outcome|Itraconazole|itraconazole alone
970334|NCT00895453|E3|Reported Event|Classic Homeopathy (CH)|"CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.~classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed): CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000."
970335|NCT00895453|E2|Reported Event|Itraconazole + Lactobacilli Agent|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)~lactobacillus gasseri: Lactobacillus vaginal tablets monthly given through 6 days"
970336|NCT00895453|E1|Reported Event|Itraconazole|"6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).~itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)"
970337|NCT00895310|B1|Baseline|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
970338|NCT00895310|P1|Participant Flow|Ketoconazole|"Ketoconazole 200mg PO (by mouth) TID (three times a day) + Hydrocortisone 20mg PO Qam (every morning), 10mg PO Qpm (every evening)~Ketoconazole: Ketoconazole is taken three times a day by mouth."
970339|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
970340|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
970341|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
970342|NCT00895310|O1|Outcome|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
970343|NCT00895310|E1|Reported Event|Ketoconazole|"Ketoconazole 200mg PO TID + Hydrocortisone 20mg PO Qam, 10mg PO Qpm~Ketoconazole: Ketoconazole is taken three times a day by mouth."
970344|NCT00895284|B3|Baseline|Total|Total of all reporting groups
970345|NCT00895284|B2|Baseline|Standard|Standard hysterectomy
970346|NCT00895284|B1|Baseline|Robot|Robotic hysterectomy
970347|NCT00895284|P2|Participant Flow|Standard|Standard hysterectomy
970348|NCT00895284|P1|Participant Flow|Robot|Robotic hysterectomy
970349|NCT00895284|O2|Outcome|Standard|Standard hysterectomy
970350|NCT00895284|O1|Outcome|Robot|Robotic hysterectomy
970351|NCT00895284|E2|Reported Event|Standard|Standard hysterectomy
970352|NCT00895284|E1|Reported Event|Robot|Robotic hysterectomy
970353|NCT00895245|B1|Baseline|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo radiotherapy"
970354|NCT00895245|P1|Participant Flow|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo radiotherapy"
970355|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
970356|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
970357|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
970358|NCT00895245|O1|Outcome|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
970359|NCT00895245|E1|Reported Event|Arm I|"Patients receive cisplatin IV on day 1. Treatment repeats every 21 days for up to 3 courses. Patients undergo radiotherapy once daily 5 days a week for up to 7 weeks.~Patients receive fosaprepitant dimeglumine IV, palonosetron hydrochloride IV, and dexamethasone IV on day 1.Patients receive oral dexamethasone on days 2-4. Patients with no emesis or need for rescue anti-emetics in the first 120 hours after cisplatin infusion continue to receive the anti-emetic regimen as above with the second and third courses of cisplatin.~Patients complete an emesis diary daily for 5 days after each cisplatin infusion. Patients also complete a Functional Living Index-Emesis Questionnaire on day 8 after each cisplatin infusion.~fosaprepitant dimeglumine: Given IV~cisplatin: Given IV~palonosetron hydrochloride: Given IV~dexamethasone: Given IV and orally~Functional Living Index-Emesis Questionnaire: Ancillary studies~Emesis Diary: Ancillary studies~Radiotherapy: Undergo r"
970360|NCT00895232|B4|Baseline|Total|Total of all reporting groups
970361|NCT00895232|B3|Baseline|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
970362|NCT00895232|B2|Baseline|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
970363|NCT00895232|B1|Baseline|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
970364|NCT00895232|P3|Participant Flow|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
970365|NCT00895232|P2|Participant Flow|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
970366|NCT00895232|P1|Participant Flow|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
970367|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
970368|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
970369|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
970370|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
970371|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
970372|NCT00895232|O1|Outcome|Cohort I (Venofer 500mg x 1 Dose)|Single 500 mg infusion of Venofer over 4 hours.
970373|NCT00895232|O3|Outcome|Cohort III (Venofer 500mg x 2 Doses)|A 500 mg infusion of Venofer over 6 hours on Day 0, followed within 24 hours by a second 500 mg infusion of Venofer over 6 hours.
970374|NCT00895232|O2|Outcome|Cohort II (Venofer 500mg X 2 Doses)|A 500 mg infusion of Venofer over 4 to 6 hours on Day 0; with a second 500 mg infusion administered between Day 2 and Day 7.
970389|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970390|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970391|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970392|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970393|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970394|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970395|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970396|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970397|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970398|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970399|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970400|NCT00895193|O4|Outcome|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970401|NCT00895193|O3|Outcome|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970402|NCT00895193|O2|Outcome|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970403|NCT00895193|O1|Outcome|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970404|NCT00895193|E4|Reported Event|Placebo Comparator|Participant receives placebo 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970405|NCT00895193|E3|Reported Event|Apple Pectin + Aspirin|Participant receives apple pectin 2000mg and aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970406|NCT00895193|E2|Reported Event|Regular Non-enteric Coated Aspirin 325mg|Participant receives aspirin 325 mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970407|NCT00895193|E1|Reported Event|Apple-pectin 2000mg|Participant receives Apple pectin 2000mg 30 minutes prior to a one-time 1000mg dose of extended-release niacin.
970408|NCT00895180|B3|Baseline|Total|Total of all reporting groups
970409|NCT00895180|B2|Baseline|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970410|NCT00895180|B1|Baseline|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970411|NCT00895180|P2|Participant Flow|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970412|NCT00895180|P1|Participant Flow|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970413|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970414|NCT00895180|O1|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970415|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970416|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970417|NCT00895180|O1|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970418|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970419|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970420|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970421|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970422|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970423|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970424|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970425|NCT00895180|O2|Outcome|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970495|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970496|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970426|NCT00895180|O1|Outcome|Group 1 Ramucirumab|Participants receive ramucirumab intravenously (IV) over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970427|NCT00895180|E2|Reported Event|Group 2 Olaratumab|Participants receive olaratumab IV over 60-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970428|NCT00895180|E1|Reported Event|Group 1 Ramucirumab|Participants receive ramucirumab IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
970429|NCT00895011|B4|Baseline|Total|Total of all reporting groups
970430|NCT00895011|B3|Baseline|Avanafil 200 mg|
970431|NCT00895011|B2|Baseline|Avanafil 100 mg|
970432|NCT00895011|B1|Baseline|Placebo|
970433|NCT00895011|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
970434|NCT00895011|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
970435|NCT00895011|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
970436|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
970437|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
970438|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
970439|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
970440|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
970441|NCT00895011|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
970442|NCT00895011|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
970443|NCT00895011|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
970444|NCT00895011|O1|Outcome|Placebo|placeb 30 minutes orally prior to initiation of sexual activity
970445|NCT00895011|E3|Reported Event|Avanafil 200 mg|
970446|NCT00895011|E2|Reported Event|Avanafil 100 mg|
970447|NCT00895011|E1|Reported Event|Placebo|
970448|NCT00894933|B1|Baseline|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970449|NCT00894933|P1|Participant Flow|Continuum|"Verify the consistency of performance of the AMS CONTINUUM device in facilitating a sustainable anastomosis following a radical prostatectomy using updated Device design elements and Physician training materials on Device implant technique.~CONTINUUM™: Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy."
970450|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970451|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970452|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970453|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970454|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970455|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970456|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970457|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970458|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970459|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970460|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970461|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970462|NCT00894933|O1|Outcome|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970463|NCT00894933|E1|Reported Event|Continuum Device|Performance evaluation of the AMS Continuum device in facilitating vesico-urethral anastomosis following a radical prostatectomy
970464|NCT00894803|B3|Baseline|Total|Total of all reporting groups
970465|NCT00894803|B2|Baseline|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970466|NCT00894803|B1|Baseline|Rt-PA Only|rt-PA (0.9 mg/kg)
970467|NCT00894803|P2|Participant Flow|Rt-PA Only|recombinant tissue Plasminogen Activator (rt-PA; 0.9 mg/kg)
970468|NCT00894803|P1|Participant Flow|Rt-PA and Eptifibatide|recombinant tissue Plasminogen Activator (rt-PA; 0.6 mg/kg) and Epifibatide (225 mcg/kg)
970469|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970470|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970471|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970472|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970473|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970474|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970475|NCT00894803|O2|Outcome|Rt-PA and Eptifibatide|rt-PA (0.6 mg/kg) and Epifibatide (225 mcg/kg)
970476|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970494|NCT00894803|O1|Outcome|Rt-PA Only|rt-PA (0.9 mg/kg)
970502|NCT00894790|B2|Baseline|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970503|NCT00894790|B1|Baseline|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970504|NCT00894790|P2|Participant Flow|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970505|NCT00894790|P1|Participant Flow|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970506|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970507|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970508|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970509|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970510|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970511|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970512|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970513|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970514|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970515|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970516|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970517|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970518|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970519|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970520|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970521|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970522|NCT00894790|O2|Outcome|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970523|NCT00894790|O1|Outcome|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970524|NCT00894790|E2|Reported Event|Diclofenac|Diclofenac 75 mg tablets twice daily up to 14 days, according to local standard of care
970525|NCT00894790|E1|Reported Event|Celecoxib|Celecoxib 400 mg capsules initial loading dose followed by 200 mg twice daily for up to 14 days
970526|NCT00894699|B3|Baseline|Total|Total of all reporting groups
970527|NCT00894699|B2|Baseline|Placebo|Single dose of Placebo
970528|NCT00894699|B1|Baseline|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil/Triazolam 15/200 mcg NanoTab™
970529|NCT00894699|P2|Participant Flow|Single Dose of Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
970530|NCT00894699|P1|Participant Flow|Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
970531|NCT00894699|O2|Outcome|Placebo NanoTab™|Single dose of sublingual Placebo NanoTab™
970532|NCT00894699|O1|Outcome|Sublingual Sufentanil 15 mcg/Triazolam NanoTab™ 200 mcg|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
970533|NCT00894699|E2|Reported Event|Placebo|Single dose of Placebo
970534|NCT00894699|E1|Reported Event|Sufentanil/Triazolam NanoTab™|Single dose of sublingual Sufentanil 15 mcg/Triazolam 200 mcg NanoTab™
970535|NCT00894647|B3|Baseline|Total|Total of all reporting groups
970536|NCT00894647|B2|Baseline|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
970537|NCT00894647|B1|Baseline|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
970538|NCT00894647|P2|Participant Flow|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
970539|NCT00894647|P1|Participant Flow|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
970540|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
970541|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
970542|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
970543|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
970544|NCT00894647|O2|Outcome|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
970545|NCT00894647|O1|Outcome|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
970546|NCT00894647|E2|Reported Event|Imiquimod Cream|Imiquimod 3.75% cream, 250 mg single-use packets, up to 2 packets applied daily
970547|NCT00894647|E1|Reported Event|Placebo Cream|placebo cream in 250 mg/packet, up to 2 packets applied daily
970548|NCT00894556|B4|Baseline|Total|Total of all reporting groups
970549|NCT00894556|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT
970609|NCT00894504|O6|Outcome|PTEN Loss|
970550|NCT00894556|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT.
970551|NCT00894556|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo.
970616|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Systemic therapy
970909|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970552|NCT00894556|P4|Participant Flow|Sumatriptan 100 mg|Pre-Randomization Phase conducted 2 months prior to Study Randomization. Eligible participants were to treat a moderate/severe migraine attack with sumatriptan 100 mg. Those who failed to respond to sumatriptan (i.e. continued to experience moderate or severe pain at 2 hours post dose) were classified as non-responders and were entered into the double-blind treatment phase of the study.
970553|NCT00894556|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Placebo; the second migraine with Rizatriptan 10mg ODT; and the third migraine with Rizatriptan 10 mg ODT"
970554|NCT00894556|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg ODT; the second migraine with placebo; and the third migraine with Rizatriptan 10 mg ODT."
970555|NCT00894556|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|"Each patient was randomized to receive one of 3 treatment sequences. Three qualifying migraines were~then treated based on the prescribed sequence. Two migraine attacks were treated with rizatriptan and one~with placebo.~The first migraine was treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); the second migraine with Rizatriptan 10 mg ODT; the third migraine with placebo."
970556|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
970557|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.~Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
970558|NCT00894556|O2|Outcome|Placebo|Migraines were treated with placebo
970559|NCT00894556|O1|Outcome|Rizatriptan|"Migraines were treated with Rizatriptan 10 mg ODT.~Although a patient may have appeared twice in the rizatriptan group, the patient was counted only once for the rizatriptan group. It is possible for one patient to be counted in both the rizatriptan and placebo groups."
970560|NCT00894556|E3|Reported Event|Sumatriptan 100 mg|"Adverse Events that occurred in the Baseline Phase (prior to taking study medication) are identified in the tables as Baseline Phase"
970561|NCT00894556|E2|Reported Event|Placebo|
970562|NCT00894556|E1|Reported Event|Rizatriptan 10 mg|"Patients took at least one dose of study medication. It is possible for one patient to be counted twice (once in each treatment group).~Although a patient may have had two or more adverse events of the same type, the patient is counted only once for that type of adverse event.~Adverse events occurring within 14 days of administration of Rizatriptan 10 mg are attributed to Rizatriptan 10 mg group even if placebo was administered more recently."
970563|NCT00894543|B3|Baseline|Total|Total of all reporting groups
970564|NCT00894543|B2|Baseline|Placebo|Inactive pill
970565|NCT00894543|B1|Baseline|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970566|NCT00894543|P2|Participant Flow|Placebo|Inactive pill
970567|NCT00894543|P1|Participant Flow|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970568|NCT00894543|O2|Outcome|Placebo|Inactive pill
970569|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970570|NCT00894543|O2|Outcome|Placebo|Inactive pill
970571|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970572|NCT00894543|O2|Outcome|Placebo|Inactive pill
970573|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970574|NCT00894543|O2|Outcome|Placebo|Inactive pill
970610|NCT00894504|O5|Outcome|PTEN Normal|
970611|NCT00894504|O4|Outcome|p53 Loss|
970612|NCT00894504|O3|Outcome|p53 Normal|
970613|NCT00894504|O2|Outcome|EGFR Amplified|
970614|NCT00894504|O1|Outcome|EGFR Normal|
970615|NCT00894504|O1|Outcome|Arm/Group 1|
970617|NCT00894504|O1|Outcome|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
970618|NCT00894504|E1|Reported Event|Panitumumab/Gemcitabine/Carboplatin|
970575|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970576|NCT00894543|O2|Outcome|Placebo|Inactive pill
970577|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970578|NCT00894543|O2|Outcome|Placebo|Inactive pill
970579|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970580|NCT00894543|O2|Outcome|Placebo|Inactive pill
970581|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970582|NCT00894543|O2|Outcome|Placebo|Inactive pill
970583|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970584|NCT00894543|O2|Outcome|Placebo|Inactive pill
970585|NCT00894543|O1|Outcome|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970586|NCT00894543|E2|Reported Event|Placebo|Inactive pill
970587|NCT00894543|E1|Reported Event|Escitalopram|Escitalopram is a selective serotonin reuptake inhibitor (SSRI). For the first four weeks, participants took 1 pill daily (escitalopram 10 mg or placebo). At 4 weeks, if hot flash frequency was not reduced by at least 50% or there was no decrease in severity, the dose was increased to 2 pills daily(escitalopram 20 mg or placebo) unless precluded by unacceptable adverse events. At 8 weeks, participants taking 1 pill per day stopped treatment; participants taking 2 pills per day tapered the dose over a week.
970588|NCT00894517|B3|Baseline|Total|Total of all reporting groups
970589|NCT00894517|B2|Baseline|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970590|NCT00894517|B1|Baseline|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970591|NCT00894517|P2|Participant Flow|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970592|NCT00894517|P1|Participant Flow|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970593|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970594|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970595|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970596|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970597|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970598|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970599|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970600|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970601|NCT00894517|O2|Outcome|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970602|NCT00894517|O1|Outcome|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970603|NCT00894517|E2|Reported Event|Placebo (Normal Saline)|Placebo (Normal saline) injected into the prostate on Day 1.
970604|NCT00894517|E1|Reported Event|Botulinum Toxin Type A|OnabotulinumtoxinA (botulinum toxin Type A) 200U injected into the prostate on Day 1.
970605|NCT00894504|B1|Baseline|Panitumumab/Gemcitabine/Carboplatin|Panitumumab - 6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Carboplatin - AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks) Gemcitabine - 1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)
970606|NCT00894504|P1|Participant Flow|Panitumumab/Gemcitabine/Carboplatin|"Treatment cycles are repeated every 14 days (2 weeks)~Panitumumab: 6mg/kg intravenous (IV), Day 1 of each 2-week treatment cycle.~Gemcitabine: 1500mg/m2 IV, Day 1 of each 2-week treatment cycle~Carboplatin: Area Under the Curve (AUC) = 2.5 IV, Day 1 of each 2-week treatment cycle"
970607|NCT00894504|O8|Outcome|PIK3CA Mutation(s)|
970608|NCT00894504|O7|Outcome|PIK3CA No Mutation|
970620|NCT00894465|B2|Baseline|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
970621|NCT00894465|B1|Baseline|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
970622|NCT00894465|P2|Participant Flow|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
970623|NCT00894465|P1|Participant Flow|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
970624|NCT00894465|O2|Outcome|Placebo|Parents of patients who were given oral placebo prior to undergoing the VCUG.
970625|NCT00894465|O1|Outcome|Versed|Parents of patients who were given oral midazolam prior to undergoing the VCUG.
970626|NCT00894465|O2|Outcome|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
970627|NCT00894465|O1|Outcome|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
970628|NCT00894465|E2|Reported Event|Placebo|"Both patients who are VCUG naive and patients who have had a previous VCUG are given an oral placebo prior to undergoing the VCUG.~placebo: Children are randomized to receive a placebo prior to undergoing VCUG"
970629|NCT00894465|E1|Reported Event|Versed|"Both patients who are VCUG naive and patients who have had a previous VCUG are given oral midazolam prior to undergoing the VCUG.~midazolam: Children are randomized to receive oral midazolam .5 mg/kg prior to undergoing VCUG"
970630|NCT00894387|B3|Baseline|Total|Total of all reporting groups
970631|NCT00894387|B2|Baseline|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970632|NCT00894387|B1|Baseline|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970633|NCT00894387|P2|Participant Flow|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970634|NCT00894387|P1|Participant Flow|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970635|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970636|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970637|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970638|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970639|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970640|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970641|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970642|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970643|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970644|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970645|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970646|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970647|NCT00894387|O2|Outcome|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970774|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970648|NCT00894387|O1|Outcome|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970649|NCT00894387|E2|Reported Event|Placebo|Randomized patients in this arm received matching placebo of Aliskiren. At week 2, Patients who could tolerate study medication were up-titrated to matching placebo of 300 mg aliskiren.
970778|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970650|NCT00894387|E1|Reported Event|Aliskiren|Randomized patients in this arm received, Aliskiren 150 mg once daily for 2 weeks. From week 2 upto 6 months , patients who could tolerate study medication were up-titrated to aliskiren 300 mg once daliy.
970651|NCT00894361|B3|Baseline|Total|Total of all reporting groups
970652|NCT00894361|B2|Baseline|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
970653|NCT00894361|B1|Baseline|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
970654|NCT00894361|P2|Participant Flow|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
970655|NCT00894361|P1|Participant Flow|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
970656|NCT00894361|O2|Outcome|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
970657|NCT00894361|O1|Outcome|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing TKA design
970658|NCT00894361|E2|Reported Event|All-polyethylene Tibia Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the all-polyethylene tibial component design
970659|NCT00894361|E1|Reported Event|Rotating-platform Design Total Knee Arthroplasty (TKA)|patients who were randomized to receive the rotating platform mobile-bearing total knee arthroplasty (TKA) design
970660|NCT00894322|B4|Baseline|Total|Total of all reporting groups
970661|NCT00894322|B3|Baseline|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970662|NCT00894322|B2|Baseline|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
970663|NCT00894322|B1|Baseline|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970664|NCT00894322|P3|Participant Flow|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970665|NCT00894322|P2|Participant Flow|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of 2 mg exenatide suspension for 12 weeks. Study medication was administered weekly.
970666|NCT00894322|P1|Participant Flow|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970667|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970668|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970669|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970670|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970671|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970672|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
980845|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
970673|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970674|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970675|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970676|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970677|NCT00894322|O2|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970678|NCT00894322|O1|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970679|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970680|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970681|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970682|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970683|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970684|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970685|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970686|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970687|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970688|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970689|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970690|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970775|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970691|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970779|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970692|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970693|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970694|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970695|NCT00894322|O3|Outcome|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970696|NCT00894322|O2|Outcome|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970697|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970698|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970699|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970700|NCT00894322|O1|Outcome|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970701|NCT00894322|E3|Reported Event|Cohort 2 Placebo|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of medium-chain triglycerides (MCT)-diluent placebo for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970702|NCT00894322|E2|Reported Event|Cohort 2 Exenatide 2 mg|On Day 1, participants with type 2 diabetes mellitus treated with diet and exercise alone or with a stable regimen of metformin, a thiazolidinedione (TZD), or a combination of metformin or a TZD were randomized to receive weekly injections of exenatide suspension for 12 weeks. Study medication was administered weekly from Visit 2 (Day 1) to Visit 15 (Week 11).
970703|NCT00894322|E1|Reported Event|Cohort 1 Exenatide 10 mg|A single 10-mg dose of exenatide once weekly suspension was given to healthy participants via 3 subcutaneous (SC) injections at Day 1. At the discretion of the investigator, participants could receive up to 2 anti-emetic medications approximately 30 minutes prior to the exenatide once weekly suspension dose.
970704|NCT00894244|B1|Baseline|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
970705|NCT00894244|P1|Participant Flow|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
970706|NCT00894244|O1|Outcome|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
970707|NCT00894244|E1|Reported Event|Thermage|Thermage ThermaCool®NXT system is a non-invasive skin tightening device designed to deliver energy to the deep dermal layer.Here it will be used to observe skin shrinkage in the arms
970708|NCT00894166|B9|Baseline|Total|Total of all reporting groups
970709|NCT00894166|B8|Baseline|Withdrew Prior to Randomization|These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.
970710|NCT00894166|B7|Baseline|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
970711|NCT00894166|B6|Baseline|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
970712|NCT00894166|B5|Baseline|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
970713|NCT00894166|B4|Baseline|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
970714|NCT00894166|B3|Baseline|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
970780|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970715|NCT00894166|B2|Baseline|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
970716|NCT00894166|B1|Baseline|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
970717|NCT00894166|P8|Participant Flow|Withdrew Prior to Randomization|"These subjects dropped from study participation after the first study session; therefore, they were never randomized into one of the study groups.~21mg (1 patch) or 42mg (2 patches) nicotine patches were dispensed for the first week of study participation during the one session they completed."
970718|NCT00894166|P7|Participant Flow|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970719|NCT00894166|P6|Participant Flow|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
970720|NCT00894166|P5|Participant Flow|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
970721|NCT00894166|P4|Participant Flow|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970722|NCT00894166|P3|Participant Flow|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
970723|NCT00894166|P2|Participant Flow|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
970724|NCT00894166|P1|Participant Flow|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970725|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970726|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
970738|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970739|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
980846|NCT00862940|E2|Reported Event|Placebo Tablets Twice Daily|
970740|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
970727|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
970728|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970729|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
970730|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
970731|NCT00894166|O1|Outcome|NRT Responder|"Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970732|NCT00894166|O7|Outcome|Post-Quit Randomized to NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first seven weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970733|NCT00894166|O6|Outcome|Post-Quit Randomized to Varenicline|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
970734|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|"Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first three weeks (# of daily patches based on baseline carbon monoxide level); starting with week 4: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches) nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
970735|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.~21mg (1 patch) or 42mg (2 patches)nicotine patches for first five weeks (# of daily patches based on baseline carbon monoxide level); 21mg nicotine patch for 4 weeks; 14mg nicotine patch for 2 weeks and 7mg nicotine patch for 2 weeks."
970736|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 0.5mg of varenicline once daily for first 3 days; 0.5mg of varenicline twice daily for the next 4 days; and 1mg of varenicline twice daily for the remainder of the study (11 weeks)."
970737|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|"Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.~21mg (1 patch) or 42mg (2 patches) nicotine patches for first week (# of daily patches based on baseline carbon monoxide level); starting with week 2: 150mg of bupropion once daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for first 3 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg (1 patch) or 42mg (2 patches)nicotine patches for 3 weeks and 4 days (# of daily patches based on baseline carbon monoxide level); 150mg of bupropion twice daily and 21mg nicotine patch for 4 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks."
970773|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970741|NCT00894166|O5|Outcome|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
970742|NCT00894166|O4|Outcome|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
970743|NCT00894166|O3|Outcome|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
970744|NCT00894166|O2|Outcome|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
970745|NCT00894166|O1|Outcome|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
970746|NCT00894166|E7|Reported Event|Post-Quit Randomized to NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use nicotine patches.
970747|NCT00894166|E6|Reported Event|Post-Quit Randomized to Varenicline|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use varenicline.
970748|NCT00894166|E5|Reported Event|Post-Quit Randomization to Bupropion + NRT|Participants who did show >50% decrease in expired air CO on pre-cessation NRT but who lapsed during the first week post quit date, who are randomly assigned to use of bupropion in combination with nicotine patches.
970749|NCT00894166|E4|Reported Event|Pre-Quit Randomization to NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment,who are randomly assigned at week 2 to use continued use of nicotine patches.
970750|NCT00894166|E3|Reported Event|Pre-Quit Randomization to Varenicline|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use varenicline.
970751|NCT00894166|E2|Reported Event|Pre-Quit Randomization to Bupropion + NRT|Participants not showing a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment, who are randomly assigned at week 2 to use Zyban (bupropion) in combination with nicotine patches.
970752|NCT00894166|E1|Reported Event|NRT Responder|Participants in this group showed both a >50% decrease in expired air CO during the 1st week of pre-cessation nicotine patch treatment and did not lapse during their 1st week after quitting.
970753|NCT00894127|B1|Baseline|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
970754|NCT00894127|P1|Participant Flow|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.
970755|NCT00894127|O1|Outcome|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
970756|NCT00894127|E1|Reported Event|Single Arm Labeling of Deep-Lung Sputum Samples With TCPP|"Deep-lung sputum was obtained from two cohorts, including (1) high-risk control group comprised of individuals not diagnosed but at high risk for lung cancer (n=102) and, (2) cancer group comprised of individuals with confirmed lung cancer diagnosis (n=26), was labeled in exact manner with TCPP and evaluated to detect red fluorescent [ie, cancer] cells (RFCs) from deep-lung sputum samples.~CyPath: CyPath diagnostic assay for the early detection of lung cancer using sputum"
970757|NCT00893997|B1|Baseline|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
970758|NCT00893997|P1|Participant Flow|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
970759|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
970760|NCT00893997|O1|Outcome|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
970761|NCT00893997|E1|Reported Event|PR-1 Vaccine|4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
970762|NCT00893971|B1|Baseline|All Subjects|Any treatment arm
970763|NCT00893971|P1|Participant Flow|Overall Study|All patients randomized
970764|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970765|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970766|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970767|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970768|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970769|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970770|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970771|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970772|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970776|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970777|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970781|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970782|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970783|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970784|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970785|NCT00893971|O1|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970786|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970787|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970788|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970789|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970790|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970791|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970792|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970793|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970794|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970795|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970796|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970797|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970798|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970799|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970800|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970801|NCT00893971|O3|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970802|NCT00893971|O2|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970803|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970804|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970805|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970806|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970807|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970808|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970809|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970810|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970811|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970812|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970813|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970814|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970815|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970816|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970817|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970818|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970819|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970820|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970821|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970822|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970823|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970824|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970825|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970826|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970827|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970828|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970829|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970830|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970831|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970832|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970833|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970834|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970835|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970836|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970837|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970838|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970839|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970840|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970841|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970842|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970843|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970844|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970845|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970846|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970847|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970848|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970849|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970850|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970851|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970852|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970853|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970854|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970855|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970856|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970857|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970858|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970859|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970860|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970861|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970862|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970863|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970864|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970865|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970866|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970867|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970868|NCT00893971|O4|Outcome|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970869|NCT00893971|O3|Outcome|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970870|NCT00893971|O2|Outcome|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970871|NCT00893971|O1|Outcome|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970872|NCT00893971|E4|Reported Event|Placebo + PT003|Placebo + Glycopyrrolate 72 µg/ Formoterol Fumarate µg
970873|NCT00893971|E3|Reported Event|PT001 + PT005|Glycopyrrolate 72 mcg + Formoterol Fumarate 9.6 µg (taken in any order)
970874|NCT00893971|E2|Reported Event|Placebo + PT005|Placebo + Formoterol Fumarate 9.6 µg
970875|NCT00893971|E1|Reported Event|Placebo + PT001|Placebo + Glycopyrrolate MDI 72 µg
970876|NCT00893789|B5|Baseline|Total|Total of all reporting groups
970877|NCT00893789|B4|Baseline|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970878|NCT00893789|B3|Baseline|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970879|NCT00893789|B2|Baseline|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970880|NCT00893789|B1|Baseline|Placebo|Oral placebo tablets, once daily (QD)
970881|NCT00893789|P4|Participant Flow|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970882|NCT00893789|P3|Participant Flow|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970883|NCT00893789|P2|Participant Flow|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970884|NCT00893789|P1|Participant Flow|Placebo|Oral placebo tablets, once daily (QD)
970885|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970886|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970887|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970888|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970889|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970890|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970891|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970892|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970893|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970894|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970895|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970896|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970897|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970898|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970899|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970900|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970901|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970902|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970903|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970904|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970905|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970906|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970907|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970908|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970910|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970911|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970912|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970913|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970914|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970915|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970916|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970917|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970918|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970919|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970920|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970921|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970922|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970923|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970924|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970925|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970926|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970927|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970928|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970929|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970930|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970931|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970932|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970933|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970934|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970935|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970936|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970937|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970938|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970939|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970940|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970941|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970942|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970943|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970944|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970945|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970946|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970947|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970948|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970949|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970950|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970951|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970952|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970953|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970954|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970955|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970956|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970957|NCT00893789|O4|Outcome|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970958|NCT00893789|O3|Outcome|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970959|NCT00893789|O2|Outcome|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970960|NCT00893789|O1|Outcome|Placebo|Oral placebo tablets, once daily (QD)
970961|NCT00893789|E4|Reported Event|Armodafinil 250 mg/Day|Oral armodafinil 250 mg tablets, once daily (QD)
970962|NCT00893789|E3|Reported Event|Armodafinil 150 mg/Day|Oral armodafinil 150 mg tablets, once daily (QD)
970963|NCT00893789|E2|Reported Event|Armodafinil 50 mg/Day|Oral armodafinil 50 mg tablets, once daily (QD)
970964|NCT00893789|E1|Reported Event|Placebo|Oral placebo tablets, once daily (QD)
970965|NCT00893763|B3|Baseline|Total|Total of all reporting groups
970966|NCT00893763|B2|Baseline|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
971148|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
970967|NCT00893763|B1|Baseline|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
970968|NCT00893763|P2|Participant Flow|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
970969|NCT00893763|P1|Participant Flow|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
1025153|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
970970|NCT00893763|O2|Outcome|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
970971|NCT00893763|O1|Outcome|1: Preintubation Oral Chlorhexidine|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
970972|NCT00893763|O2|Outcome|2: COntrol|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
970973|NCT00893763|O1|Outcome|1: Preintubation Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
970974|NCT00893763|E2|Reported Event|2: Control|Control: No pre-intubation intervention, 5 ml CHX gluconate 0.12% solution twice a day following intubation
970975|NCT00893763|E1|Reported Event|1: Intervention|Intervention: Oral application of 5 ml CHX gluconate 0.12% solution pre-intubation, and 5 ml CHX gluconate 0.12% solution twice a day following intubation.
970976|NCT00893737|B1|Baseline|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
970977|NCT00893737|P1|Participant Flow|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
970978|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
970979|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
970980|NCT00893737|O1|Outcome|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
970981|NCT00893737|E1|Reported Event|Treximet|Treximet (a combination of sumatriptan 85 mg and naproxen sodium 500 mg) 1 tablet to be administered as soon as patient has headache indicative of migraine. Patient may treat up to 16 migraine attacks in 2 month study period.
970982|NCT00893464|B9|Baseline|Total|Total of all reporting groups
970983|NCT00893464|B8|Baseline|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970984|NCT00893464|B7|Baseline|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970985|NCT00893464|B6|Baseline|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970986|NCT00893464|B5|Baseline|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970987|NCT00893464|B4|Baseline|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970988|NCT00893464|B3|Baseline|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970989|NCT00893464|B2|Baseline|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970990|NCT00893464|B1|Baseline|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970991|NCT00893464|P8|Participant Flow|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970992|NCT00893464|P7|Participant Flow|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970993|NCT00893464|P6|Participant Flow|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970994|NCT00893464|P5|Participant Flow|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708) 1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970995|NCT00893464|P4|Participant Flow|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970996|NCT00893464|P3|Participant Flow|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970997|NCT00893464|P2|Participant Flow|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
970998|NCT00893464|P1|Participant Flow|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until progressive disease (PD) or unacceptable toxicity.
970999|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971431|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971000|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971001|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971002|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971003|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971004|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971005|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971006|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971007|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971008|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971009|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971010|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971011|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971012|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971013|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971014|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971015|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971016|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971017|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971018|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971019|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971020|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971021|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971022|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971023|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971024|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971025|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971026|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971027|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971028|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971029|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971030|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971031|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971032|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971033|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
980847|NCT00862940|E1|Reported Event|Memantine 10 mg Tablets Twice Daily|
971034|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971035|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971036|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971037|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971038|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971039|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971040|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971041|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971042|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971043|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971044|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971045|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971046|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity..
971047|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971048|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971049|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971050|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971051|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971052|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971053|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971054|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971055|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971056|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971057|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971058|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971059|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971060|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971061|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971062|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971063|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971064|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971065|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971066|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971067|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
981025|NCT00862563|B5|Baseline|Total|Total of all reporting groups
971068|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971069|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971070|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971071|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971072|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971073|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971074|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971075|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971076|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971077|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971078|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971079|NCT00893464|O1|Outcome|All Participants|All participants who received MLN9708 at dose 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 and 3.11 mg/m^2 in Phase 1.
971080|NCT00893464|O1|Outcome|All Participants|All participants who received ixazomib (MLN9708) 0.125 mg/m^2, 0.25 mg/m^2, 0.5 mg/m^2, 1.0 mg/m^2, 1.4 mg/m^2, 1.76 mg/m^2, 2.34 mg/m^2 or 3.11 mg/m^2 in dose-escalation cohorts .
971081|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971082|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971083|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971084|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971085|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971086|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971087|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971088|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971089|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971090|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971091|NCT00893464|O6|Outcome|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971092|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971093|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971094|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971095|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971096|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971097|NCT00893464|O8|Outcome|Ixazomib 3.11 mg/m²|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971098|NCT00893464|O7|Outcome|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971099|NCT00893464|O6|Outcome|Ixazomib1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971100|NCT00893464|O5|Outcome|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971101|NCT00893464|O4|Outcome|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971102|NCT00893464|O3|Outcome|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971103|NCT00893464|O2|Outcome|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971104|NCT00893464|O1|Outcome|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971105|NCT00893464|E8|Reported Event|Ixazomib 3.11 mg/m^2|Ixazomib (MLN9708) 3.11 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971106|NCT00893464|E7|Reported Event|Ixazomib 2.34 mg/m^2|Ixazomib (MLN9708) 2.34 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971107|NCT00893464|E6|Reported Event|Ixazomib 1.76 mg/m^2|Ixazomib (MLN9708) 1.76 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971108|NCT00893464|E5|Reported Event|Ixazomib 1.4 mg/m^2|Ixazomib (MLN9708)1.4 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971109|NCT00893464|E4|Reported Event|Ixazomib 1.0 mg/m^2|Ixazomib (MLN9708) 1.0 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971110|NCT00893464|E3|Reported Event|Ixazomib 0.5 mg/m^2|Ixazomib (MLN9708) 0.5 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971111|NCT00893464|E2|Reported Event|Ixazomib 0.25 mg/m^2|Ixazomib (MLN9708) 0.25 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971112|NCT00893464|E1|Reported Event|Ixazomib 0.125 mg/m^2|Ixazomib (MLN9708) 0.125 mg/m^2, injection, intravenously, once weekly on Days 1, 8, and 15 in 28-day treatment cycles until PD or unacceptable toxicity.
971113|NCT00893152|B3|Baseline|Total|Total of all reporting groups
971114|NCT00893152|B2|Baseline|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
971115|NCT00893152|B1|Baseline|Veterans|Participants in focus groups or individual qualitative interviews
971116|NCT00893152|P2|Participant Flow|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
971117|NCT00893152|P1|Participant Flow|Veterans|Participants in focus groups or individual qualitative interviews
971118|NCT00893152|O2|Outcome|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
971119|NCT00893152|O1|Outcome|Veterans|Participants in focus groups or individual qualitative interviews
971120|NCT00893152|E2|Reported Event|Family Members|Family members of participating veterans who also took part in a focus group or individual qualitative interview
971121|NCT00893152|E1|Reported Event|Veterans|Participants in focus groups or individual qualitative interviews
971122|NCT00893113|B3|Baseline|Total|Total of all reporting groups
971123|NCT00893113|B2|Baseline|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
971124|NCT00893113|B1|Baseline|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
971125|NCT00893113|P2|Participant Flow|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
971126|NCT00893113|P1|Participant Flow|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
971127|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
971128|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
971129|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
971130|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
971131|NCT00893113|O2|Outcome|Alfuzosin|Participants who received Alfuzosin 10 mg table in either the first or last 12 weeks of the study.
971132|NCT00893113|O1|Outcome|Placebo|Participants who received Placebo tablet (matching Alfuzosin 10 mg) in either the first or last 12 weeks of the study.
971133|NCT00893113|E2|Reported Event|Alfuzosin, Then Placebo|Alfuzosin: 10 mg once daily first, then one Placebo tablet daily
971134|NCT00893113|E1|Reported Event|Placebo, Then Alfuzosin|Placebo: one tablet daily first, then 10 mg Alfuzosin daily
971135|NCT00892957|B3|Baseline|Total|Total of all reporting groups
971136|NCT00892957|B2|Baseline|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
971137|NCT00892957|B1|Baseline|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
971138|NCT00892957|P2|Participant Flow|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
971139|NCT00892957|P1|Participant Flow|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
971140|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971141|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971142|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971143|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971144|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971145|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971146|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971147|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971149|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971150|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971151|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971152|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971153|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
1025154|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
971154|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971155|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971156|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971157|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971158|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971159|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971160|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971161|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971162|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971163|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971164|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971165|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971166|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971167|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971168|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971169|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971170|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971171|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971172|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971173|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971174|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971175|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971176|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971177|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971178|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971179|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971180|NCT00892957|O4|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
971181|NCT00892957|O3|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
971182|NCT00892957|O2|Outcome|FS VH S/D 500 S-apr: Postoperative Day 14|FS VH S/D 500 s-apr, 120 seconds polymerization
971183|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Baseline|FS VH S/D 500 s-apr, 120 seconds polymerization
971184|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971185|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
971186|NCT00892957|O2|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971187|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
971188|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971189|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971190|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971191|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
971192|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971193|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
971194|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971195|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
971196|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971197|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971198|NCT00892957|O6|Outcome|Control: Preop Baseline - Postoperative Day 14|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971199|NCT00892957|O5|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 14|FS VH S/D 500 s-apr was applied to the study suture line
971200|NCT00892957|O4|Outcome|Control: Preop Baseline - Postoperative Day 1|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971201|NCT00892957|O3|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Postoperative Day 1|FS VH S/D 500 s-apr was applied to the study suture line
971202|NCT00892957|O2|Outcome|Control: Preop Baseline - Intraoperative Day 0|Manual compression with surgical gauze - Dry gauze pads were positioned to cover the complete study suture line
971203|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr: Preop Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr was applied to the study suture line
971438|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971204|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971205|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971206|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971207|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971208|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971209|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971210|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971211|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971212|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971213|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971214|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971215|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971216|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971217|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971218|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971219|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971220|NCT00892957|O2|Outcome|Control - Manual Compression With Surgical Gauze|Dry gauze pads were positioned to cover the complete study suture line
971221|NCT00892957|O1|Outcome|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr was applied to the study suture line
971222|NCT00892957|E2|Reported Event|Control - Manual Compression With Surgical Gauze Pads|Dry gauze pads will be positioned to cover the complete study suture line.
971223|NCT00892957|E1|Reported Event|FS VH S/D 500 S-apr|FS VH S/D 500 s-apr will be applied to the study suture line.
971224|NCT00892723|B4|Baseline|Total|Total of all reporting groups
971225|NCT00892723|B3|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971226|NCT00892723|B2|Baseline|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971227|NCT00892723|B1|Baseline|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971228|NCT00892723|P3|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971229|NCT00892723|P2|Participant Flow|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971230|NCT00892723|P1|Participant Flow|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971231|NCT00892723|O9|Outcome|Scar Total Volume - 1 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971232|NCT00892723|O8|Outcome|Scar Total Volume - 0.3 mg AZX100|This group included Month 12 scar total volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971233|NCT00892723|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971234|NCT00892723|O6|Outcome|Scar Negative Volume - 1 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971235|NCT00892723|O5|Outcome|Scar Negative Volume - 0.3 mg AZX100|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971236|NCT00892723|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971237|NCT00892723|O3|Outcome|Scar Positive Volume - 1 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971238|NCT00892723|O2|Outcome|Scar Positive Volume - 0.3 mg AZX100|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received 0.3 mg AZx100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971239|NCT00892723|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume measurements (mm^3) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971432|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971240|NCT00892723|O15|Outcome|Scar Mean Elevation - 1 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971268|NCT00892723|E2|Reported Event|High Dose|AZX100 Drug Product 1 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971241|NCT00892723|O14|Outcome|Scar Mean Elevation - 0.3 mg AZX100|This group included Month 12 scar mean elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971242|NCT00892723|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971243|NCT00892723|O12|Outcome|Scar Maximum Elevation - 1 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971244|NCT00892723|O11|Outcome|Scar Maximum Elevation - 0.3 mg AZX100|This group included Month 12 scar maximum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971245|NCT00892723|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation measurements f(mm) or those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971246|NCT00892723|O9|Outcome|Scar Minimum Elevation - 1 mg AZX100|This group included Month 12 scar minimum elevation measurements f(mm) or those patients who received 1 mg/ AZX100linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971247|NCT00892723|O8|Outcome|Scar Minimum Elevation - 0.3 mg AZX100|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971248|NCT00892723|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971249|NCT00892723|O6|Outcome|Scar Width - 1 mg AZX100|This group included Month 12 scar width measurements (mm)for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971250|NCT00892723|O5|Outcome|Scar Width - 0.3 mg AZX100|This group included Month 12 scar width measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971251|NCT00892723|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width measurements (mm) for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971252|NCT00892723|O3|Outcome|Scar Length - 1 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971253|NCT00892723|O2|Outcome|Scar Length - 0.3 mg AZX100|This group included Month 12 scar length measurements (mm) for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971254|NCT00892723|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length measurements (mm)for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971255|NCT00892723|O6|Outcome|Rater 2 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971256|NCT00892723|O5|Outcome|Rater 2 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971257|NCT00892723|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971258|NCT00892723|O3|Outcome|Rater 1 VAS Scores for 1 mg AZX100|This group included Month 12 VAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971259|NCT00892723|O2|Outcome|Rater 1 VAS Scores for 0.3 mg AZX100|This group included Month 12 VAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971260|NCT00892723|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971261|NCT00892723|O6|Outcome|OSAS Results for 1 mg AZX100|This group included Month 12 OSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971262|NCT00892723|O5|Outcome|OSAS Results for 0.3 mg AZX100|This group included Month 12 OSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971263|NCT00892723|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971264|NCT00892723|O3|Outcome|PSAS Results for 1 mg AZX100|This group included Month 12 PSAS scores for those patients who received 1 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971265|NCT00892723|O2|Outcome|PSAS Results for 0.3 mg AZX100|This group included Month 12 PSAS scores for those patients who received 0.3 mg AZX100/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971266|NCT00892723|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for those patients who received placebo (saline)/linear centimeter intradermally along the excision line at 21 days and 42 days after surgery.
971305|NCT00892606|B1|Baseline|Methadone|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg of methadone IV immediately after intubation
971267|NCT00892723|E3|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971269|NCT00892723|E1|Reported Event|Low Dose|AZX100 Drug Product 0.3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
971270|NCT00892710|B4|Baseline|Total|Total of all reporting groups
971271|NCT00892710|B3|Baseline|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971272|NCT00892710|B2|Baseline|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971273|NCT00892710|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971274|NCT00892710|P3|Participant Flow|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971275|NCT00892710|P2|Participant Flow|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971276|NCT00892710|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971277|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971278|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971279|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971280|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971281|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971282|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971283|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971284|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971285|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971286|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971287|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971288|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971289|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971290|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971291|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971292|NCT00892710|O3|Outcome|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971293|NCT00892710|O2|Outcome|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971294|NCT00892710|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971295|NCT00892710|E3|Reported Event|Pemetrexed/Bevacizumab/Carboplatin|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days~Carboplatin: AUC=5 IV every 21 days"
971296|NCT00892710|E2|Reported Event|Pemetrexed/Bevacizumab|"Pemetrexed: 500 mg/m2 IV given over 10 minutes every 21 days~Bevacizumab: 15 mg/kg IV every 21 days"
971297|NCT00892710|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 IV given over 10 minutes every 21 days
971298|NCT00892697|B1|Baseline|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
971299|NCT00892697|P1|Participant Flow|Telaprevir/Peg-IFN/RBV|"15 subjects received Telaprevir in combination with pegylated interferon and ribavirin.~Telaprevir: Fifteen subjects received the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg)."
971300|NCT00892697|O1|Outcome|Telaprevir/PEG-IFN/RBV|15 subjects will receive Telaprevir in combination with pegylated interferon alfa-2a and ribavirin
971301|NCT00892697|O1|Outcome|Telaprevir/Peg-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
971302|NCT00892697|E1|Reported Event|Telaprevir/PEG-IFN/RBV|"15 subjects will receive Telaprevir in combination with pegylated interferon and ribavirin and 5 additional subjects on standard of care.~Telaprevir: Fifteen subjects will receive the same treatment: 12 weeks of telaprevir (750 mg q8h) with Peg-IFN- alfa-2a (Pegasys(R)) (180 mcg SQ qwk) and RBV (1200 mg per day if >75 kg or 1000mg per day if < 75 kg). Additional 5 subjects be on standard of therapy."
971303|NCT00892606|B3|Baseline|Total|Total of all reporting groups
971304|NCT00892606|B2|Baseline|Control|Patients received 2 µg/kg fentanyl, 0.2 mg/kg ketamine, and 0.2 mg/kg morphine
971433|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971306|NCT00892606|P2|Participant Flow|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
971307|NCT00892606|P1|Participant Flow|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
971308|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
971309|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
971310|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
971311|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
971312|NCT00892606|O2|Outcome|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
971313|NCT00892606|O1|Outcome|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
971314|NCT00892606|E2|Reported Event|Control|"Patient will receive current standard-of-care: 0.2 mg/kg of morphine IV immediately after intubation~Morphine: Patients will receive 0.2 mg/kg of morphine IV immediately after intubation"
971315|NCT00892606|E1|Reported Event|Methadone|"Patients will receive 0.2 mg/kg of methadone IV immediately after intubation~Methadone: Patients will receive 0.2 mg/kg of methadone IV immediately after intubation"
971316|NCT00892437|B3|Baseline|Total|Total of all reporting groups
971317|NCT00892437|B2|Baseline|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971318|NCT00892437|B1|Baseline|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971319|NCT00892437|P2|Participant Flow|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971320|NCT00892437|P1|Participant Flow|ATV+COBI+FTC/TDF|"Randomized Phase: Cobicistat (COBI) 150 mg + ritonavir (RTV) placebo + atazanavir (ATV) 300 mg + emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971321|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971322|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971323|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971324|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971325|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971326|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971327|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971328|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971329|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971330|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971331|NCT00892437|O2|Outcome|ATV+RTV+FTC/TDF|"Randomized Phase: RTV 100 mg + COBI placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971332|NCT00892437|O1|Outcome|ATV+COBI+FTC/TDF|"Randomized Phase: COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily~Open-Label Extension Phase: COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) once daily"
971333|NCT00892437|E3|Reported Event|All ATV+COBI+FTC/TDF|The All ATV+COBI+FTC/TDF Safety Analysis Set included all participants who received at least 1 dose of COBI 150 mg + ATV 300 mg + FTC/TDF (200/300 mg) in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind ATV+COBI+FTC/TDF group while they received double-blind ATV+COBI+FTC/TDF during the randomized phase and open-label ATV+COBI+FTC/TDF during the extension phase; adverse events collected from the open-label ATV+COBI+FTC/TDF extension phase only from the participants who were initially randomized to the ATV+RTV+FTC/TDF group during the randomized phase. Adverse event data collected up to Week 286 are presented in this entry.
971334|NCT00892437|E2|Reported Event|ATV+RTV+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive RTV 100 mg+COBI placebo+ATV 300 mg+FTC 200 mg/TDF 300 mg once daily in the randomized period, and were analyzed from Baseline to Week 60.
971335|NCT00892437|E1|Reported Event|ATV+COBI+FTC/TDF|For the reporting of Adverse Events, this group includes participants who were randomized to receive COBI 150 mg + RTV placebo + ATV 300 mg + FTC/TDF (200/300 mg) once daily in the randomized phase, and were analyzed from Baseline to Week 60.
971336|NCT00892281|B3|Baseline|Total|Total of all reporting groups
971436|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971337|NCT00892281|B2|Baseline|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
971338|NCT00892281|B1|Baseline|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
971339|NCT00892281|P2|Participant Flow|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
971340|NCT00892281|P1|Participant Flow|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
971341|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
971342|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
971343|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
971344|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
971345|NCT00892281|O2|Outcome|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
971346|NCT00892281|O1|Outcome|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
971347|NCT00892281|E2|Reported Event|Oracea® as add-on Therapy|Oracea® 40 mg/day as add-on Therapy (Oracea + Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Doses and timing information were not specified in the protocol. Add-on therapies were permitted in three classes of drug as described above (Metronidazoles and/or Azelaic Acids and/or Sodium Sulfacetamides). Add-on therapies were taken according to the appropriate package insert.
971348|NCT00892281|E1|Reported Event|Oracea® as Monotherapy|Oracea® 40 mg per day as monotherapy.
971349|NCT00892151|B1|Baseline|Intended Users of the Software|Baseline measures apply to lay persons (n=40) not healthcare professionals in the study.
971350|NCT00892151|P1|Participant Flow|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
971351|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
971352|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
971353|NCT00892151|O1|Outcome|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
971354|NCT00892151|E1|Reported Event|Intended Users of the Software|10 Healthcare Professionals and 40 persons with diabetes (of which 6 were parents/legal guardians of children with diabetes) used a diabetes data management program.
971355|NCT00892099|B4|Baseline|Total|Total of all reporting groups
971356|NCT00892099|B3|Baseline|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
971357|NCT00892099|B2|Baseline|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
971358|NCT00892099|B1|Baseline|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
971359|NCT00892099|P3|Participant Flow|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
971360|NCT00892099|P2|Participant Flow|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
971361|NCT00892099|P1|Participant Flow|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
971362|NCT00892099|O3|Outcome|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
971363|NCT00892099|O2|Outcome|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
971364|NCT00892099|O1|Outcome|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
971365|NCT00892099|E3|Reported Event|Placebo|"Receives no ergocalciferol~Placebo: Placebo equivalent of ergocalciferol, given weekly as one tablet"
971366|NCT00892099|E2|Reported Event|Low Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol per month~Ergocalciferol: 50,000 IU tablet given monthly"
971367|NCT00892099|E1|Reported Event|High Dose Ergocalciferol|"Receives 50,000 IU of ergocalciferol weekly~Ergocalciferol: 50,000 IU tablet given weekly"
971368|NCT00892047|B3|Baseline|Total|Total of all reporting groups
971395|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971369|NCT00892047|B2|Baseline|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
1025155|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
971370|NCT00892047|B1|Baseline|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study. Will be randomized to aripiprazole or placebo for up to 24 weeks."
971371|NCT00892047|P2|Participant Flow|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
971372|NCT00892047|P1|Participant Flow|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
971373|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
971374|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
971375|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
971376|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
971377|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
971378|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
971379|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
971380|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
971381|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
971382|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
971383|NCT00892047|O2|Outcome|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
971384|NCT00892047|O1|Outcome|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage of venlafaxine ranged from 150mg to 300mg. Dose of aripirpazole ranged from 2mg to 15mg. Subject remained on venlafaxine throughout the 36 week study. Subject remained on aripiprazole or placebo for up to 24 weeks."
971385|NCT00892047|E2|Reported Event|2: Placebo Comparator|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine plus placebo: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives placebo for up to 24 weeks."
971386|NCT00892047|E1|Reported Event|1: Venlafaxine Plus Aripiprazole|"antidepressant (venlafaxine) plus aripiprazol or venlafaxine plus placebo~venlafaxine XR plus aripiprazole: Dosage varies. Subject remains on antidepressant throughout the 36 week study and also receives aripiprazole 2mg to 15mg daily for up to 24 weeks."
971387|NCT00892008|B1|Baseline|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971388|NCT00892008|P1|Participant Flow|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971389|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971390|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971391|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971392|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971393|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971394|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971396|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971437|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971397|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971398|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971399|NCT00892008|O1|Outcome|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971400|NCT00892008|E1|Reported Event|Pregabalin|75-150 milligrams (mg) twice a day (BID) for at least 2 weeks; followed by optional upward dose titration to 600 mg/day at the discretion of the physician/investigator.
971401|NCT00891995|B3|Baseline|Total|Total of all reporting groups
971402|NCT00891995|B2|Baseline|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971403|NCT00891995|B1|Baseline|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971404|NCT00891995|P2|Participant Flow|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971405|NCT00891995|P1|Participant Flow|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and continuous glucose monitoring (CGM) in addition to standard monitoring with a home glucose meter for 2 years.
971406|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971407|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971408|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971409|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971410|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971411|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971412|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971413|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971414|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971415|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971416|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971417|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971418|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971419|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971420|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971421|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971422|NCT00891995|O2|Outcome|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971423|NCT00891995|O1|Outcome|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971424|NCT00891995|E2|Reported Event|Standard Treatment|The Standard Care group will receive standard diabetes management using a home glucose meter for blood sugar monitoring for 2 years.
971425|NCT00891995|E1|Reported Event|Intensive Treatment|The Intensive Treatment group will participate in 4-6 days of inpatient closed loop therapy followed by use of an insulin pump and CGM in addition to standard monitoring with a home glucose meter for 2 years.
971426|NCT00891982|B3|Baseline|Total|Total of all reporting groups
971427|NCT00891982|B2|Baseline|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971428|NCT00891982|B1|Baseline|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971429|NCT00891982|P2|Participant Flow|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971430|NCT00891982|P1|Participant Flow|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
981346|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
971434|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971435|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971439|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971440|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971441|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971442|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971443|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971444|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971445|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971446|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971447|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971448|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971449|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971450|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971451|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971452|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971453|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971454|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971455|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971456|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971457|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971458|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971459|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971460|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971461|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971462|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971463|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971464|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971465|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971466|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971467|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971468|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971469|NCT00891982|O2|Outcome|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971470|NCT00891982|O1|Outcome|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971471|NCT00891982|E2|Reported Event|CTGel|Soap Free Cleanser in the morning and CTGel in the evening
971472|NCT00891982|E1|Reported Event|CTGel Plus BPO Wash|BPO Wash in the morning and CTGel in the evening
971473|NCT00891930|B1|Baseline|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971474|NCT00891930|P1|Participant Flow|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971475|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971476|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971477|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971478|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971479|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971480|NCT00891930|O1|Outcome|Panitumumab|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W) during Part 1. Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971481|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971482|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
972062|NCT00890084|E1|Reported Event|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
971483|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971484|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971596|NCT00891462|P1|Participant Flow|Placebo|Inhaled placebo for 12 weeks
971485|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971486|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971487|NCT00891930|O2|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971488|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971489|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971490|NCT00891930|O1|Outcome|Part 2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971491|NCT00891930|O1|Outcome|Part 1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971492|NCT00891930|E2|Reported Event|Part-2: Panitumumab + Ganitumab|Upon radiographically confirmed disease progression, participants proceeded to Part 2 of the study and received treatment with panitumumab (6 mg/kg starting dose) and ganitumab (12 mg/kg starting dose) Q2W.
971493|NCT00891930|E1|Reported Event|Part-1: Panitumumab + Irinotecan|Participants received panitumumab (6 mg/kg starting dose) with irinotecan (starting dose of 180 mg/m²) every 2 weeks (Q2W).
971494|NCT00891904|B1|Baseline|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
971495|NCT00891904|P1|Participant Flow|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
971496|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
971497|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
971498|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
971499|NCT00891904|O1|Outcome|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
971500|NCT00891904|E1|Reported Event|Biological/Vaccine: Cetuximab|"All patients enrolled will receive cetuximab 400 mg/m 2 IV x 1 dose 1 week prior to delivery of SBRT. Patients will then receive 15 Gy x 1 using SBRT and cetuximab i.v.~250 mg/m2 weekly for 4 weeks (total of 5 doses at 250 mg/m2)."
971501|NCT00891839|B1|Baseline|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971502|NCT00891839|P1|Participant Flow|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971503|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971504|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971505|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971506|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971507|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971535|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
981347|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
971508|NCT00891839|O1|Outcome|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971966|NCT00890721|B2|Baseline|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
971509|NCT00891839|E1|Reported Event|Bendamustine+Rituximab|Participants receive bendamustine at 90 mg/m^2 intravenously (iv) on days 1 and 2, and 375 mg/m^2 of rituximab by iv on day 1 of each 28-day cycle. Six 28-day cycles were planned and up to 8 cycles permitted for patients who do not have progressive disease and who have not achieved a complete response (CR).
971510|NCT00891813|B1|Baseline|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
971511|NCT00891813|P1|Participant Flow|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
971512|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
971513|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
971514|NCT00891813|O1|Outcome|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
971515|NCT00891813|E1|Reported Event|Paricalcitol Injection|Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels.
971516|NCT00891774|B1|Baseline|Device|Treatment with EVOLENCE®
971517|NCT00891774|P1|Participant Flow|Device|Treatment with EVOLENCE®
971518|NCT00891774|O1|Outcome|Device|Treatment with EVOLENCE®
971519|NCT00891774|E1|Reported Event|Device|Treatment with EVOLENCE®
971520|NCT00891735|B5|Baseline|Total|Total of all reporting groups
971521|NCT00891735|B4|Baseline|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971522|NCT00891735|B3|Baseline|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971523|NCT00891735|B2|Baseline|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971524|NCT00891735|B1|Baseline|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971525|NCT00891735|P4|Participant Flow|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971526|NCT00891735|P3|Participant Flow|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971527|NCT00891735|P2|Participant Flow|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971528|NCT00891735|P1|Participant Flow|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971529|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971530|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971531|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971532|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971533|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971534|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971536|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971594|NCT00891462|P3|Participant Flow|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
1025156|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
971537|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971538|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971539|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971540|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971541|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971542|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971543|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971544|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971545|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971546|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971547|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971548|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971549|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971550|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971551|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971552|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971553|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971554|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971555|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971556|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971557|NCT00891735|O4|Outcome|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971558|NCT00891735|O3|Outcome|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971559|NCT00891735|O2|Outcome|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971560|NCT00891735|O1|Outcome|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971561|NCT00891735|E4|Reported Event|Ranibizumab 2.0 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 2.0 mg administered intravitreally.
971593|NCT00891462|B1|Baseline|Placebo|Inhaled placebo for 12 weeks
972063|NCT00889928|B1|Baseline|Cholecystectomy|transvaginal cholecystectomy
971595|NCT00891462|P2|Participant Flow|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
971562|NCT00891735|E3|Reported Event|Ranibizumab 0.5 mg As-needed (Pro re Nata [PRN])|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 3 months. Thereafter, patients' visual acuity and eye disease activity were assessed monthly for an additional 9 months. If study defined criteria were met at a monthly assessment, patients received ranibizumab 0.5 mg administered intravitreally.
971563|NCT00891735|E2|Reported Event|Ranibizumab 2.0 mg Monthly|Patients received ranibizumab 2.0 mg monthly administered intravitreally for 12 months.
971564|NCT00891735|E1|Reported Event|Ranibizumab 0.5 mg Monthly|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 12 months.
971565|NCT00891657|B3|Baseline|Total|Total of all reporting groups
971566|NCT00891657|B2|Baseline|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
971567|NCT00891657|B1|Baseline|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
971568|NCT00891657|P2|Participant Flow|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
971569|NCT00891657|P1|Participant Flow|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
971570|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
971571|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
971572|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
971573|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
971574|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
971575|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
971576|NCT00891657|O2|Outcome|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
971577|NCT00891657|O1|Outcome|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
971578|NCT00891657|E2|Reported Event|Control|The subjects randomized to the Control group received standard good surgical care, excluding any use of anti-adhesion products.
971579|NCT00891657|E1|Reported Event|SprayShield™|The SprayShield™ is a synthetic, sprayable polyethylene glycol (PEG) based absorbable gel adhesion barrier, that consists of two liquids that when mixed together rapidly cross-link to form a biocompatible absorbable flexible hydrogel that conforms and adheres to the tissues to which it is applied.
971580|NCT00891618|B1|Baseline|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
971581|NCT00891618|P1|Participant Flow|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
971582|NCT00891618|O1|Outcome|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
971583|NCT00891618|E1|Reported Event|Acupuncture|Three (3) acupuncture sessions per week for 4 weeks (Weeks 1-4), 1 week off (Week 5), then 2 per week for 4 more weeks (Weeks 6-10), total of 20 sessions. Each session lasts 20-30 minutes.
971584|NCT00891527|B1|Baseline|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
971585|NCT00891527|P1|Participant Flow|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
971586|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease, significant lung disease, and those who progressed were also treated with Avastin (bevacizumab).
971587|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
971588|NCT00891527|O1|Outcome|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease, significant lung disease, and those who progressed were also treated with Avastin (bevacizumab).
971589|NCT00891527|E1|Reported Event|Avastin and/or Gleevec|Patients were all treated with Gleevec (imatinib mesylate) and those without congenital heart disease and those who progressed were also treated with Avastin (bevacizumab).
971590|NCT00891462|B4|Baseline|Total|Total of all reporting groups
971591|NCT00891462|B3|Baseline|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
971592|NCT00891462|B2|Baseline|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
971597|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
971598|NCT00891462|O2|Outcome|Aclidinium Bromide, 200 µg|Aclidinium bromide, 200 µg dose, Oral inhalation, twice per day, for 12 weeks of treatment
971599|NCT00891462|O1|Outcome|Placebo|Dose matched placebo twice per day, inhaled for 12 weeks of treatment
971600|NCT00891462|O3|Outcome|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
971601|NCT00891462|O2|Outcome|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
971602|NCT00891462|O1|Outcome|Placebo|Dose-matched placebo twice per day, inhaled for 12 weeks of treatment
971603|NCT00891462|E3|Reported Event|Aclidinium Bromide, 400µg|Aclidinium bromide 400 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment.
971604|NCT00891462|E2|Reported Event|Aclidinium Bromide, 200µg|Aclidinium bromide, 200 microgram dose. Oral inhalation, twice per day, for 12 weeks of treatment
971605|NCT00891462|E1|Reported Event|Placebo|Inhaled placebo for 12 weeks
971606|NCT00891436|B3|Baseline|Total|Total of all reporting groups
971607|NCT00891436|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
971608|NCT00891436|B1|Baseline|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
971609|NCT00891436|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
971610|NCT00891436|P1|Participant Flow|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
971611|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
971612|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
971613|NCT00891436|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
971614|NCT00891436|O1|Outcome|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
971615|NCT00891436|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray : 2 sprays each nostril every morning for 2 weeks
971616|NCT00891436|E1|Reported Event|Fluticasone Furoate Nasal Spray|Fluticasone furoate nasal spray : 2 sprays each nostril every morning for 2 weeks
971617|NCT00891371|B1|Baseline|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
971618|NCT00891371|P1|Participant Flow|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28.
971619|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
971620|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
971621|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
971622|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
971623|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
971624|NCT00891371|O1|Outcome|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
971625|NCT00891371|E1|Reported Event|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg one subcutaneous injection on Day 1 and Day 28
971626|NCT00891293|B1|Baseline|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971627|NCT00891293|P1|Participant Flow|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971628|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971629|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971630|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971631|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971632|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971633|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971634|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971635|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971636|NCT00891293|O1|Outcome|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971637|NCT00891293|E1|Reported Event|Lovaza (Formerly Known as Omacor) and Fenofibrate|Open-label Lovaza (omega-3-acid ethyl esters)[formerly known as Omacor] 4 g/day and open-label fenofibrate 130 mg/day
971638|NCT00891202|B3|Baseline|Total|Total of all reporting groups
971639|NCT00891202|B2|Baseline|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
971640|NCT00891202|B1|Baseline|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
971935|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971641|NCT00891202|P4|Participant Flow|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971642|NCT00891202|P3|Participant Flow|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971643|NCT00891202|P2|Participant Flow|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
971644|NCT00891202|P1|Participant Flow|PAP: Eliglustat|Eliglustat tartrate capsule as a single 50 milligram (mg) dose on Day 1 followed by eliglustat tartrate 50 mg capsule twice daily (BID) from Day 2 to Week 4, and then either eliglustat tartrate 50 mg capsule BID (in participants who had a Genz-99067 [active moiety of eliglustat tartrate in plasma] trough plasma concentration greater than or equal to [>=] 5 nanogram per milliliter [ng/mL]) or eliglustat tartrate 100 mg capsule BID (in participants who had a Genz-99067 trough plasma concentration less than [<] 5 ng/mL), up to Week 39. The pharmacokinetic (PK) assessment at Week 2 was used for dose adjustment after Week 4.
971645|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971646|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971647|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971648|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971649|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971650|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971651|NCT00891202|O2|Outcome|LTTP: Eliglustat (Originally on Placebo)|Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline of LTTP for this arm. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971934|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971936|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971652|NCT00891202|O1|Outcome|LTTP: Eliglustat (Originally on Eliglustat)|Participants of the eliglustat arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate capsule 50 mg BID orally from Day 1 (post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971653|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
971654|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
971655|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
971656|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
971657|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
971658|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
971659|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
971660|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
971661|NCT00891202|O2|Outcome|PAP: Placebo|Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39.
971662|NCT00891202|O1|Outcome|PAP: Eliglustat|Eliglustat tartrate 50 mg capsule BID orally from Day 1 to Week 4, followed by eliglustat tartrate 50 mg or 100 mg capsule BID orally up to Week 39.
971663|NCT00891202|E2|Reported Event|Placebo|PAP: Matching placebo capsule once daily on Day 1 followed by matching placebo capsule BID from Day 2 through Week 39. LTTP: Participants of the placebo arm in PAP who completed PAP were included in LTTP and received eliglustat tartrate from Day 1 (post Week 39) up to Week 312. Day 1 (post Week 39) was considered as baseline for LTTP. On Day 1, participants received eliglustat tartrate capsule 50 mg BID orally until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 and Week 47 were based on Genz-99067 trough plasma concentrations (if trough plasma concentration <5 ng/mL: next higher dose administered; if >=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971664|NCT00891202|E1|Reported Event|Eliglustat|PAP: Eliglustat tartrate capsule 50 mg orally on Day 1 followed by eliglustat tartrate 50 mg capsule BID from Day 2 to Week 4, then either eliglustat tartrate 50 mg capsule BID(participants with Genz-99067 trough plasma concentration>=5 ng/mL) or eliglustat tartrate 100 mg capsule BID(participants with Genz-99067 trough plasma concentration<5 ng/mL), up to Week 39. PK assessment at Week 2 used for dose adjustment after Week 4. LTTP: Participants of the eliglustat arm in PAP who completed PAP were included in LTTP & received eliglustat tartrate capsule 50 mg BID orally from Day 1(post Week 39) until Week 43 followed by eliglustat tartrate 50 mg or 100 mg capsule BID up to Week 47, then eliglustat tartrate 50 mg or 100 mg or 150 mg capsule BID up to Week 312. Dose adjustments at Week 43 & Week 47 were based on Genz-99067 trough plasma concentrations(if trough plasma concentration<5 ng/mL: next higher dose administered;if>=5 ng/mL: same dose continued) at Week 41 & Week 45, respectively.
971665|NCT00891176|B5|Baseline|Total|Total of all reporting groups
971666|NCT00891176|B4|Baseline|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971667|NCT00891176|B3|Baseline|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971668|NCT00891176|B2|Baseline|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971669|NCT00891176|B1|Baseline|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971806|NCT00891046|P3|Participant Flow|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971670|NCT00891176|P4|Participant Flow|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971671|NCT00891176|P3|Participant Flow|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971672|NCT00891176|P2|Participant Flow|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971673|NCT00891176|P1|Participant Flow|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age. 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971674|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971675|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971676|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971677|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971678|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971679|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971680|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
981348|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
971681|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971682|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971683|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971684|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971685|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971686|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971687|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971688|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971689|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971690|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971691|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
972064|NCT00889928|P1|Participant Flow|Cholecystectomy|transvaginal cholecystectomy
971692|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971693|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971694|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971695|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971696|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971697|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971698|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971699|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971700|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971701|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971702|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971703|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971704|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971705|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971706|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971707|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971708|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971709|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971710|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971711|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971712|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971713|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971714|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971715|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971716|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971717|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971718|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971719|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971720|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971721|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971722|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971723|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971724|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
972065|NCT00889928|O1|Outcome|Transvaginal Cholecystectomy|
971725|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971726|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971727|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971728|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971729|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971730|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971731|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971732|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971733|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971734|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971735|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
972066|NCT00889928|E1|Reported Event|Cholecystectomy|transvaginal cholecystectomy
971736|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971737|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971738|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971739|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971740|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971741|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971742|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971743|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971744|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971745|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971746|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971747|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971748|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971749|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971750|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971751|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971752|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971753|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971754|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971755|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971756|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971757|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971758|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971759|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971760|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971761|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971762|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971763|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971764|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971765|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971766|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971767|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971768|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
972067|NCT00889915|B5|Baseline|Total|Total of all reporting groups
971769|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971770|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971771|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971772|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971773|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971774|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971775|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971776|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971777|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971778|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971779|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
972473|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
971780|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971781|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971782|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971783|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971784|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971785|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971786|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971787|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971788|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971789|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971790|NCT00891176|O4|Outcome|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971791|NCT00891176|O3|Outcome|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971792|NCT00891176|O2|Outcome|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971793|NCT00891176|O1|Outcome|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971794|NCT00891176|E4|Reported Event|Prevenar-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Prevenar intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971795|NCT00891176|E3|Reported Event|Synflorix-Menitorix Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 3 primary doses of Menitorix intramuscularly into the lower left thigh at 2, 4 and 6 months of age and 3 primary doses of Infanrix penta intramuscularly into the upper left thigh at 2, 4 and 6 months of age. During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV was given instead of Infanrix penta.
971796|NCT00891176|E2|Reported Event|Synflorix-NeisVac-C Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Neis-Vac-C intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Neis-Vac-C at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971797|NCT00891176|E1|Reported Event|Synflorix-Meningitec Group|Subjects who received concomitantly in the primary study (NCT00334334): 3 primary doses of Synflorix intramuscularly into the right thigh at 2, 4 and 6 months of age, 2 primary doses of Meningitec intramuscularly into the lower left thigh at 2 and 4 months of age and 3 primary doses of Infanrix hexa intramuscularly into the upper left thigh at 2, 4 and 6 months of age. (In Poland subjects were offered a third dose of Meningitec at 7 months of age to comply with national recommendations). During the booster study (NCT00463437) subjects received the same vaccines as during the primary study at 11-18 months of age, with the exception of Spain, where Infanrix IPV/Hib was given instead of Infanrix hexa.
971798|NCT00891046|B6|Baseline|Total|Total of all reporting groups
971799|NCT00891046|B5|Baseline|ACZ885 Treatment Naive|Participants who were canakinumab treatment­ naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971800|NCT00891046|B4|Baseline|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971801|NCT00891046|B3|Baseline|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971802|NCT00891046|B2|Baseline|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971803|NCT00891046|B1|Baseline|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971804|NCT00891046|P5|Participant Flow|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971805|NCT00891046|P4|Participant Flow|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
972266|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
971807|NCT00891046|P2|Participant Flow|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed Study CACZ885G2301 (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971808|NCT00891046|P1|Participant Flow|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from Study CACZ885G2301 Part 2 (NCT00889863) due to SJIA flare, received a subcutaneous (s.c.).
971809|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971810|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971811|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971812|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971813|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971814|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971815|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971816|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971817|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971818|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971819|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971820|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971821|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971822|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971823|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971824|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971825|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971826|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971827|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971828|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971829|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
972188|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
971830|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971831|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971832|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971833|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971834|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971835|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971836|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971837|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971838|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971839|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971840|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971841|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971842|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971843|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971844|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971845|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971846|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971847|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971848|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971849|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971850|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971851|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies NCT00889863 and NCT00886769, but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971931|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971852|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in NCT00889863; received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971853|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study NCT00889863, received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971854|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from NCT00889863, received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971855|NCT00891046|O5|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971856|NCT00891046|O4|Outcome|ACZ885 Treated: Group 4 (Other Criteria)|Participants who previously received canakinumab treatment in Studies CACZ885G2301 (NCT00889863) and CACZ885G2305 (NCT00886769), but did not fulfill the criteria for Group 1, 2 or 3, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971857|NCT00891046|O3|Outcome|ACZ885 Treated: Group 3 (Steroid Taper Failures in Core Study)|Participants who failed to taper their steroid dose in CACZ885G2301 Study ­Part I (NCT00889863); received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971858|NCT00891046|O2|Outcome|ACZ885 Treated: Group 2 (Completed Core Study)|Participants who completed study CACZ885G2301 ­ Part II (NCT00889863), received an s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971859|NCT00891046|O1|Outcome|ACZ885 Treated: Group 1 (Discontinued From Core Study)|Participants who discontinued from CACZ885G2301 study Part II (NCT00889863), received a subcutaneous (s.c.) injection of canakinumab 4 mg/kg every 4 weeks unless discontinuation occurs. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971860|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to other biologics, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971861|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued other biologics for other reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971862|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued other biologics for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971863|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment­ naive and who discontinued other biologics due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971864|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to tocilizumab, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971865|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971866|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued tocilizumab for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971867|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued tocilizumab due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971868|NCT00891046|O4|Outcome|ACZ885 Treatment Naive: Group 4|Participants who were canakinumab treatment naive and who never exposed to anakinra, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971869|NCT00891046|O3|Outcome|ACZ885 Treatment Naive: Group 3|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971870|NCT00891046|O2|Outcome|ACZ885 Treatment Naive: Group 2|Participants who were canakinumab treatment naive and who discontinued anakinra for safety/tolerability reasons, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971871|NCT00891046|O1|Outcome|ACZ885 Treatment Naive: Group 1|Participants who were canakinumab treatment naive and who discontinued anakinra due to lack of efficacy, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971872|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971873|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971874|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971875|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971876|NCT00891046|O2|Outcome|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971877|NCT00891046|O1|Outcome|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971878|NCT00891046|E2|Reported Event|ACZ885 Treatment Naive|Participants who were canakinumab treatment naive and did not participate in previous canakinumab studies, received a s.c. injection of canakinumab 4 mg/kg every 4 weeks. Canakinumab 2 mg/kg was administered for participants who were able to taper their steroid dose.
971879|NCT00891046|E1|Reported Event|ACZ885 Treated|Participants who were responsive to canakinumab in previous studies: NCT00889863 and NCT00886769 and entered into this extension study in Group 1, 2, 3 and 4.
971880|NCT00891020|B4|Baseline|Total|Total of all reporting groups
971881|NCT00891020|B3|Baseline|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971882|NCT00891020|B2|Baseline|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971883|NCT00891020|B1|Baseline|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971884|NCT00891020|P3|Participant Flow|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971885|NCT00891020|P2|Participant Flow|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971886|NCT00891020|P1|Participant Flow|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971887|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971888|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971889|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971890|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971891|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971892|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
972267|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
971893|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971894|NCT00891020|O1|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971895|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971896|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971897|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971898|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971899|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971900|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971901|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971902|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971903|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971904|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971905|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971906|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971932|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971933|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971907|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971908|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971909|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971910|NCT00891020|O3|Outcome|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971911|NCT00891020|O2|Outcome|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971912|NCT00891020|O1|Outcome|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab (TCZ) 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971913|NCT00891020|E3|Reported Event|Tocilizumab 8 mg/kg + DMARD|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. The dosage could be decreased to 4 mg/kg for safety reasons at the investigator's discretion. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971914|NCT00891020|E2|Reported Event|Tocilizumab 4 mg/kg + DMARD|Participants received Tocilizumab (TCZ) 4 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusion plus non-biologic disease-modifying antirheumatic drug (DMARD) of the investigator's choice for 24 weeks. Participants not achieving a 20% improvement from baseline in tender and swollen joint counts at Week 8 were to have their dosage increased to 8 mg/kg, per protocol. Beginning at Week 12 dosage increase to 8 mg/kg was at the discretion of the investigator. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971915|NCT00891020|E1|Reported Event|Tocilizumab 8 mg/kg Monotherapy|Participants received Tocilizumab 8 mg/kg as a 60 minute intravenous infusion every 4 weeks for a total of 6 infusions for 24 weeks. Participants who completed the 24 week treatment period were offered the option of entering a long-term extension phase.
971916|NCT00890981|B3|Baseline|Total|Total of all reporting groups
971917|NCT00890981|B2|Baseline|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971918|NCT00890981|B1|Baseline|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971919|NCT00890981|P2|Participant Flow|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971920|NCT00890981|P1|Participant Flow|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179 (NCT00293813). No study drug was administered during this study.
971921|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971922|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971923|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971924|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971925|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971926|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971927|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971928|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971929|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971930|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
972356|NCT00888355|B5|Baseline|Total|Total of all reporting groups
971937|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971938|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971939|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971940|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971941|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971942|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971943|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971944|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971945|NCT00890981|O2|Outcome|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971946|NCT00890981|O1|Outcome|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971947|NCT00890981|E2|Reported Event|Previous Denosumab Treatment Group|Participants who had previously received denosumab and completed Study 20050179. No study drug was administered during this study.
971948|NCT00890981|E1|Reported Event|Previous Placebo Treatment Group|Participants who had previously received placebo and completed Study 20050179. No study drug was administered during this study.
971949|NCT00890929|B1|Baseline|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971950|NCT00890929|P1|Participant Flow|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971951|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971952|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971953|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971954|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971955|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971956|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971957|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971958|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971959|NCT00890929|O1|Outcome|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971960|NCT00890929|E1|Reported Event|Azacitidine Followed by Lenalidomide|"Dose escalation then dose expansion~Lenalidomide: 5 mg, 10 mg, 25 mg, and/or 50 mg of lenalidomide administered PO from day 8 to Day 28 of each cycle~Azacitidine: 75 mg/m2 Azacitidine administered intravenously (IV) or subcutaneously (SC) for days 1 to 7 of each cycle"
971961|NCT00890916|B1|Baseline|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels. Also known as the IST-12 System."
971962|NCT00890916|P1|Participant Flow|Neuroprosthesis System|Subjects who have undergone implantation of the neuroprosthesis system known as the FIRSTHAND/IST-12 System.
971963|NCT00890916|O1|Outcome|Neuroprosthesis System|Subjects with the implanted FIRSTHAND/IST-12 System.
971964|NCT00890916|E1|Reported Event|Neuroprosthesis System|"Receives implanted device for hand function.~FIRSTHAND System: Implanted neuroprosthesis with myoelectric control and electrical stimulation of multiple channels."
971965|NCT00890721|B3|Baseline|Total|Total of all reporting groups
1025157|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
971967|NCT00890721|B1|Baseline|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
971968|NCT00890721|P2|Participant Flow|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
971969|NCT00890721|P1|Participant Flow|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
971970|NCT00890721|O2|Outcome|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
971971|NCT00890721|O1|Outcome|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
971972|NCT00890721|E2|Reported Event|Placebo|During the hemorrhoidectomy, 30cc Placebo injected into the wound.
971973|NCT00890721|E1|Reported Event|SKY0402|During the hemorrhoidectomy, 30cc of SKY0402 is injected into the wound.
971974|NCT00890695|B3|Baseline|Total|Total of all reporting groups
971975|NCT00890695|B2|Baseline|2 Normal Diet|normal diet arm
971976|NCT00890695|B1|Baseline|1 RUSF|RUSF prescribed for the child for 4 weeks
971977|NCT00890695|P2|Participant Flow|2 Normal Diet|For equity, parents or guardians of children in the usual diet arm are given 2 bags of maize meal (4Kg) for family consumption instead of RUSF. All parents and carers in both arms will also receive standard nutritional advice as specified in the current WHO IMCI handbook.
971978|NCT00890695|P1|Participant Flow|1 Ready to Use Supplementary Food (RUSF)|"Products, Kenya. The RUSF composition is in accordance with recommended supplementary feed composition specified by the latest WHO expert consultation in 2008 reported by Golden et al. It is formulated to provide 507 kcal per 100g, 6% protein/energy ratio and 55% fat/energy ratio. Essential fatty acids contained are N-6 (linoleic acid) 6 kcal % and N-3 (o-linoleic) 0.3 kcal %. Vitamin and mineral premix (3%) will provide the currently recommended nutrient intake for moderately malnourished children of minerals (K, Na, Ca, P, Mg, Fe, Zn, Cu, Se, I, Mn, Cr, Mo, F), Vitamins (thiamine, riboflavin, pyridoxine, niacin, Vit B12, folic acid, Vit C, Biotin, Pantothenic acid, Vit A, Vit D,Vit E and Vit K).~initial visit. The amount supplied is based on the child's weight; the recommended energy supplement being 100kcal per kg per day which is equivalent to 25g RUSF per kg per day."
971979|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
971980|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
971981|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
971982|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
971983|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
971984|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
971985|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
971986|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
971987|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
971988|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
971989|NCT00890695|O2|Outcome|2 Normal Diet|normal diet arm
971990|NCT00890695|O1|Outcome|1 RUSF|RUSF prescribed for the child for 4 weeks
971991|NCT00890695|E2|Reported Event|2 Normal Diet|normal diet arm
971992|NCT00890695|E1|Reported Event|1 RUSF|RUSF prescribed for the child for 4 weeks
971993|NCT00890682|B3|Baseline|Total|Total of all reporting groups
971994|NCT00890682|B2|Baseline|Placebo|Study Drug Injection
971995|NCT00890682|B1|Baseline|Sky0402|Injection of Study Drug
971996|NCT00890682|P2|Participant Flow|Placebo|Injection of 8cc Placebo (single dose)
971997|NCT00890682|P1|Participant Flow|SKY0402|Injection of 8cc SKY0402 (single dose)
971998|NCT00890682|O2|Outcome|Placebo|Single injection of study drug
971999|NCT00890682|O1|Outcome|SKY0402|Single injection of study drug
972000|NCT00890682|E2|Reported Event|Placebo|Study Drug Injection
972001|NCT00890682|E1|Reported Event|Sky0402|Injection of Study Drug
972002|NCT00890656|B1|Baseline|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
972003|NCT00890656|P1|Participant Flow|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
972004|NCT00890656|O1|Outcome|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
972005|NCT00890656|E1|Reported Event|Augmented Hyper-CVAD|Hyper-CVAD (courses 1, 3, 5, and 7) alternated with high-dose methotrexate/ara-C (courses 2, 4, 6, and 8) administered on day 21; Hyper-CVAD = Cyclophosphamide, Vincristine, Doxorubicin, Decadron + Pegaspargase.
972006|NCT00890591|B1|Baseline|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
972024|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
972025|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
972189|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972026|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
972027|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
972007|NCT00890591|P1|Participant Flow|Olmesartan + Hydrochlorothiazide + Amlodipine|"olmesartan monotherapy was the starting dosage regimen. Blood pressure (BP) measurments were obtained at 4, 8 and 9 weeks. If BP goals were not met at a measurment point the participant's medication was elevated to the next step and BP measurments taken at the next 4, 8, and 9 weeks.~olmesartan 20 mg/ hydrochlorothiazide 12.5 mg tablets was the first titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets was the second titration regimen if blood pressure goals were not achieved~olmesartan 40 mg + hydrochlorothiazide 25 mg tablets + amlodipine 5 mg tablets was the third titration regimen if blood pressure goals were not achieved"
972008|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide + Amlodipine|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets + amlodipine tablets 5 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
972009|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 40 mg/+ hydrochlorothiazide 25 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
972010|NCT00890591|O1|Outcome|Olmesartan + Hydrochlorothiazide|olmesartan 20 mg/hydrochlorothiazide 12.5 mg tablets for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
972011|NCT00890591|O1|Outcome|Olmesartan Monotherapy|olmesartan monotherapy 20 mg for 4-9 weeks based on blood pressure (BP) measurements at 4, 8 or 9 weeks. Participant went to next treatment if BP > or = to 140/90 mm Hg
972012|NCT00890552|B1|Baseline|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
972013|NCT00890552|P1|Participant Flow|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
972014|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
972015|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
972016|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
972017|NCT00890552|O1|Outcome|Lenalidomide, Melphalan and Dexamethasone (MDR)|"The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.~Lenalidomide: Orally-administered lenalidomide 10 mg will be taken daily on days 1 to 21 of 28-day cycle. Lenalidomide is a a derivative of thalidomide.~Melphalan: Orally-administered melphalan 0.18 mg/kg will be taken on days 1 to 4 of a 28-day cycle. Melphalan is a phenylalanine derivative of mechlorethamine.~Dexamethasone: Orally-administered dexamethasone 40 mg will be taken on days 1; 8; 15; and 22 of a 28-day cycle. Dexamethasone is an anti-inflammatory and immunosuppressant steroid medication."
972018|NCT00890552|E1|Reported Event|Lenalidomide, Melphalan and Dexamethasone (MDR)|The 3-drug combination of orally-administered lenalidomide; melphalan; and dexamethasone (MDR) will be administered as nine 28-day cycles, with the option of continuing treatment with lenalidomide as single-agent.
972019|NCT00890409|B3|Baseline|Total|Total of all reporting groups
972020|NCT00890409|B2|Baseline|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
972021|NCT00890409|B1|Baseline|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
972022|NCT00890409|P2|Participant Flow|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
972023|NCT00890409|P1|Participant Flow|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
972060|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972061|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972028|NCT00890409|O2|Outcome|Hypothermia|The group was fitted with a cooling cap around the head for 72 hours. The temperature of the cap could be adjusted between 5 to 20 degree C and was automatically regulated by a servo-controlled temperature probe placed in the nasopharynx to maintain the nasopharyngeal temperature at (34±0.2)degree C.
972029|NCT00890409|O1|Outcome|Normothermia|Rectal temperature in the group was maintained at 36 to 37.5 degree C.
972030|NCT00890201|B3|Baseline|Total|Total of all reporting groups
972031|NCT00890201|B2|Baseline|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
972032|NCT00890201|B1|Baseline|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
972033|NCT00890201|P2|Participant Flow|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
972034|NCT00890201|P1|Participant Flow|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
972035|NCT00890201|O2|Outcome|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
972036|NCT00890201|O1|Outcome|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
972037|NCT00890201|E2|Reported Event|Gallbladder With Gallstones|"Patients submitted to elective cholecystectomy for diseased gallbladders (gallbladder with gallstones evidenced by preoperative ultrasound).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography and the preoperative amylase and lipase levels must also be normal."
972038|NCT00890201|E1|Reported Event|Normal Gallbladder|"Patients with normal gallbladder (without gallstones) evidenced by preoperative ultrasonography (and postoperative biopsy) submitted to elective gastroesophageal surgery (gastrectomy for gastric cancer, bariatric surgery or esophageal surgery such as Nissen plicature or miotomy for achalasia).~The pancreaticobiliary junction must be normal as evidenced by intraoperative cholangiography. Preoperative values of amylase and lipase must be normal."
972039|NCT00890097|B4|Baseline|Total|Total of all reporting groups
972040|NCT00890097|B3|Baseline|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972041|NCT00890097|B2|Baseline|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972042|NCT00890097|B1|Baseline|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
972043|NCT00890097|P3|Participant Flow|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972044|NCT00890097|P2|Participant Flow|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972045|NCT00890097|P1|Participant Flow|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
972046|NCT00890097|O3|Outcome|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972047|NCT00890097|O2|Outcome|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972048|NCT00890097|O1|Outcome|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
972049|NCT00890097|E3|Reported Event|Vehicle|AL-8309B Vehicle, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972050|NCT00890097|E2|Reported Event|AL-8309B 1.75%|AL-8309B 1.75% Ophthalmic Solution, 1 drop in each eye twice daily, for 30 months up to a maximum of 36 months
972051|NCT00890097|E1|Reported Event|AL-8309B 1.0%|AL-8309B 1.0% Ophthalmic Solution, 1 drop in each eye twice daily for 30 months, up to a maximum of 36 months
972052|NCT00890084|B1|Baseline|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972053|NCT00890084|P1|Participant Flow|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972054|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972055|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972056|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972057|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972058|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972059|NCT00890084|O1|Outcome|Telmisartan or Telmisartan + Hydrochlorothiazide (HCTZ)|
972421|NCT00888329|P1|Participant Flow|Aprepitant|40 mg aprepitant
972089|NCT00889915|E3|Reported Event|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
972192|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972068|NCT00889915|B4|Baseline|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~The dose form for is 5, 10, 15, 20, 25, 30 mg capsules. The typical starting dose for children greater than or equal to 6 years of age is 10 mg every day.~The FDA maximum dose per day is 30 mg if weight is greater than 50 kilograms. The off label maximum dose per day is 60 mg. The capsule may be opened and sprinkled on soft foods."
972069|NCT00889915|B3|Baseline|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 18, 27, 36, 54 mg capsules. The typical starting dose is 18 mg every morning. The FDA maximum dose per day is 54 mg in children or 72 mg in adolescents. The off label maximum dose is 108 mg. Longer acting stimulants offer greater convenience, confidentiality, and compliance with single daily dosing, but may have greater problematic effects on evening appetite and sleep. Its nonabsorbable tablet shell may appear in the stool.~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
972070|NCT00889915|B2|Baseline|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form is 20, 30, 40, 50, 60, 70 mg ivory body/ivory cap. The typical starting dose is 30 mg every day in the morning; dosage may be adjusted in increments of 10 mg or 20 mg at approximately weekly intervals.~The FDA maximum dose per day is 70 mg. Afternoon doses should be avoided because of the potential for insomnia. Vyvanse may be taken with or without food. Vyvanse capsules may be taken whole, or the capsule may be opened and the entire contents dissolved in a glass of water. The solution should be consumed immediately and should not be stored. The dose of a single capsule should not be divided."
972071|NCT00889915|B1|Baseline|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system. Although not specified by protocol, rather determined by local standard of care, the typical doses and strategies are as follows:~Dose form as 10, 15, 20, 30 mg patches. Typical starting dose is 10 mg patch every day then titrate up by patch strength.~The FDA maximum dose per day is 30 mg and the off label maximum dose per day is 40 mg.~The patch should be applied to the hip area, avoiding the waistline and the patch application should be alternated between hips."
972072|NCT00889915|P4|Participant Flow|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
972073|NCT00889915|P3|Participant Flow|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
972074|NCT00889915|P2|Participant Flow|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
972075|NCT00889915|P1|Participant Flow|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
972076|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
972077|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
972078|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
972079|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
972080|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
972081|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
972082|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
972083|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
972084|NCT00889915|O4|Outcome|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
972085|NCT00889915|O3|Outcome|Concerta (Osmotic-release Oral System Methylphenidate)|"Participants will receive osmotic-release oral system methylphenidate (OROS MPH).~Osmotic-release oral system methylphenidate (OROS MPH) : Not specified in protocol; determined by local standard of care."
972086|NCT00889915|O2|Outcome|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
972087|NCT00889915|O1|Outcome|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
972088|NCT00889915|E4|Reported Event|Adderall (Mixed Amphetamine Salts Extended Release)|"Participants will receive mixed amphetamine salts extended release.~Mixed amphetamine salts extended release : Not specified in protocol; determined by local standard of care."
972190|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972090|NCT00889915|E2|Reported Event|Vyvanse (Lisdexamfetamine Dimesylate)|"Participants will receive lisdexamfetamine dimesylate.~Lisdexamfetamine dimesylate : Not specified in protocol; determined by local standard of care."
972091|NCT00889915|E1|Reported Event|Daytrana (Methylphenidate Transdermal System|"Participants will receive methylphenidate transdermal system.~Methylphenidate transdermal system : Not specified in protocol; determined by local standard of care."
972092|NCT00889863|B1|Baseline|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972093|NCT00889863|P2|Participant Flow|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972094|NCT00889863|P1|Participant Flow|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972095|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972096|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972097|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972098|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972099|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972100|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972101|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972112|NCT00889863|E3|Reported Event|Placebo: Part II|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972153|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972271|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972102|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972103|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972104|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972105|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972106|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972107|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972108|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972109|NCT00889863|O2|Outcome|Placebo|Participants in Part II received placebo matching canakinumab subcutaneous injection every 4 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972110|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972111|NCT00889863|O1|Outcome|Canakinumab|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period. Participants were then randomized to receive either 4 mg/kg canakinumab subcutaneous injection or Placebo comparator in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972113|NCT00889863|E2|Reported Event|Canakinumab: Part II|Participants received 4 mg/kg canakinumab subcutaneous injection in Part II and remained on the stable oral steroid dose for 24 weeks. At 24 weeks in Part II participants with a >0.2 mg/kg and ≤ 0.5 mg/kg and no flare could restart steroid tapering. If the steroid dose was ≤ 0.2 mg/kg participants continued to maintain their current dose for the remainder of Part II.
972114|NCT00889863|E1|Reported Event|Canakinumab: Part I|In Part I participants received open label 4 mg/kg canakinumab subcutaneous injection every 4 weeks for up to 32 weeks. For the first 8 weeks Part Ia (4 weeks) and Ib (4 weeks) patients maintained a stable oral steroid dose (prednisone or equivalent) followed by Ic an up to 20 week steroid tapering period and then Id a 4 week stable steroid dose period.
972115|NCT00889824|B1|Baseline|Balcap Group|Each participant received Balcap Tactile prosthesis
972116|NCT00889824|P1|Participant Flow|Balcap Group|"Balcap group~Balcap group; balance prosthesis : vibrotactile stimulation~Patients wore a Balcap device that provided a vibrotactile stimulation that felt like a buzz either in front, back, or either side of their head when they swayed a certain distance from their center.~They wore the device daily and performed specific personalized exercises as prescribed by a physical therapist. They were tested with and without the balcap during tests of balance and postural stability when they first received the balcap and again six weeks later.~Each patient wore the balcap device a total of six weeks and then returned the device."
972117|NCT00889824|O1|Outcome|Balcap Group|Vibrotactile stimulation exercises with the device over a span of 6 weeks
972118|NCT00889824|E1|Reported Event|Balcap Group|Each participant received Balcap Tactile prosthesis
972119|NCT00888940|B3|Baseline|Total|Total of all reporting groups
972120|NCT00888940|B2|Baseline|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
972121|NCT00888940|B1|Baseline|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
972122|NCT00888940|P2|Participant Flow|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
972123|NCT00888940|P1|Participant Flow|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
972124|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
972125|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
972126|NCT00888940|O2|Outcome|Cyklokapron(R)|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
972127|NCT00888940|O1|Outcome|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
972128|NCT00888940|E2|Reported Event|Cyklokapron|1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime
972129|NCT00888940|E1|Reported Event|Ecallantide|2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion
972130|NCT00888849|B3|Baseline|Total|Total of all reporting groups
972131|NCT00888849|B2|Baseline|Suturing|4 layered hand-sutured anastomosis
972132|NCT00888849|B1|Baseline|Stapling|
972133|NCT00888849|P2|Participant Flow|Suturing|4 layered hand-sutured anastomosis
972134|NCT00888849|P1|Participant Flow|Stapling|
972135|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
972136|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
972137|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
972138|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
972139|NCT00888849|O2|Outcome|Stapling|Stapled Anastomosis
972140|NCT00888849|O1|Outcome|Suturing|Hand-sutured anastomosis
972141|NCT00888849|E2|Reported Event|Suturing|4 layered hand-sutured anastomosis
972142|NCT00888849|E1|Reported Event|Stapling|
972143|NCT00889720|B1|Baseline|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972144|NCT00889720|P1|Participant Flow|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972145|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972146|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972147|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972148|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972149|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972150|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972151|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972152|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972265|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972154|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972155|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972156|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972157|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972158|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972159|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972160|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972161|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972162|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972163|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972164|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972165|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972166|NCT00889720|O1|Outcome|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972167|NCT00889720|E1|Reported Event|Varenicline|Week 1: Day 1 through Day 3: varenicline 0.5 mg once a day, Day 4 through Day 7: varenicline 0.5 mg twice daily (BID); Week 2 through Week 12: varenicline 1 mg BID with option to reduce to 0.5 mg BID depending on toleration.
972168|NCT00889707|B3|Baseline|Total|Total of all reporting groups
972169|NCT00889707|B2|Baseline|Placebo|2% HSA without PRX302
972170|NCT00889707|B1|Baseline|PRX302|0.6 microgram/gram prostate in 2% HSA
972171|NCT00889707|P2|Participant Flow|Placebo|2% (weight/volume) human serum albumin (HSA) without PRX302
972172|NCT00889707|P1|Participant Flow|PRX302|0.6 microgram/gram prostate weight in 2% (weight/volume) human serum albumin (HSA)
972173|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
972174|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
972175|NCT00889707|O2|Outcome|Placebo|2% HSA without PRX302
972176|NCT00889707|O1|Outcome|PRX302|0.6 microgram/gram prostate in 2% HSA
972177|NCT00889707|E2|Reported Event|Placebo|2% HSA without PRX302
972178|NCT00889707|E1|Reported Event|PRX302|0.6 microgram/gram prostate in 2% HSA
972179|NCT00889681|B1|Baseline|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study to receive cryoablation treatment for paroxysmal atrial fibrillation.
972180|NCT00889681|P1|Participant Flow|Enrolled for Cryoablation Treatment|All patients that signed the informed consent were considered enrolled. Patients enrolled in the study received cryoablation treatment for paroxysmal atrial fibrillation.
972181|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
972182|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
972183|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
972184|NCT00889681|O1|Outcome|Treated With Cryoablation|Enrolled patients that underwent a cryoablation procedure for the treatment of paroxysmal atrial fibrillation.
972185|NCT00889681|E1|Reported Event|Treated With Cryoablation|"This study is a single arm, non-randomized controlled study of patients with PAF referred for ablation after failing one or more antiarrhythmic drugs used in the treatment of AF (Atrial Fibrillation Drugs  or AFDs). All study subjects will be receiving cryoablation with the experimental devices and, optionally, an Atrial Fibrillation Drug.~Arctic Front Cardiac Cryoablation System : The CryoCath Arctic Front® Cardiac CryoAblation Catheter System, including the Freezor MAX Cardiac Cryoablation Catheter, is indicated for the treatment of patients with paroxysmal atrial fibrillation to reduce the likelihood of subsequent detectable atrial fibrillation."
972186|NCT00889603|B1|Baseline|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972187|NCT00889603|P1|Participant Flow|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972191|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972272|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972193|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972194|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972195|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972196|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972197|NCT00889603|O1|Outcome|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972198|NCT00889603|E1|Reported Event|Donepezil|5 milligrams per day (mg/day), once-a-day dosing and after 4 weeks titrated to 10 mg/day, once-a-day dosing
972199|NCT00889512|B3|Baseline|Total|Total of all reporting groups
972200|NCT00889512|B2|Baseline|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
972201|NCT00889512|B1|Baseline|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
972202|NCT00889512|P2|Participant Flow|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
972203|NCT00889512|P1|Participant Flow|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
972204|NCT00889512|O2|Outcome|Luveris Increasing Dose|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
972205|NCT00889512|O1|Outcome|Luveris Fixed Dose|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
972206|NCT00889512|E2|Reported Event|Group B|"Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.~Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG"
972207|NCT00889512|E1|Reported Event|Group A|"Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.~Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation"
972208|NCT00889421|B1|Baseline|Treatment|Patient receiving apremilast.
972209|NCT00889421|P1|Participant Flow|Treatment|Patient receiving apremilast.
972210|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
972211|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
972212|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
972213|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
972214|NCT00889421|O1|Outcome|Treatment|Patient receiving apremilast.
972215|NCT00889421|E1|Reported Event|Treatment|Patient receiving apremilast.
972216|NCT00889330|B3|Baseline|Total|Total of all reporting groups
972217|NCT00889330|B2|Baseline|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972218|NCT00889330|B1|Baseline|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972219|NCT00889330|P2|Participant Flow|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972220|NCT00889330|P1|Participant Flow|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972221|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972222|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972223|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972224|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972225|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972226|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972227|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972228|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972229|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972230|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972231|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972232|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972233|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972234|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972235|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972236|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972237|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972238|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972239|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972240|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972241|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972242|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972243|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972244|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972245|NCT00889330|O2|Outcome|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972246|NCT00889330|O1|Outcome|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972247|NCT00889330|E2|Reported Event|Inactive Vehicle Ophthalmic Solution|inactive treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972248|NCT00889330|E1|Reported Event|Alcaftadine Ophthalmic Solution|active treatment: administered as a single dose of one drop per eye at each of two visits, Day 0 and Day 14.
972249|NCT00889265|B1|Baseline|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
972250|NCT00889265|P1|Participant Flow|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
972251|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
972252|NCT00889265|O1|Outcome|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
972253|NCT00889265|E1|Reported Event|CopiOs Pericardium|"Subject's study site must exhibit a partially edentulous ridge of the maxilla or mandible with at least one tooth-span in length and less than 5.5mm in its smallest buccolingual dimension as measured by ridge-mapping calipers.~CopiOs Pericardium Membrane: CopiOs Pericardium Membrane (CopiOs Pericardium), a bovine xenograft 20mm x 30mm; Puros Cancellous Particulate Allograft (Puros Cancellous) 2 cubic centimeters (cc) of small particle (250-1000um)."
972254|NCT00889252|B3|Baseline|Total|Total of all reporting groups
972255|NCT00889252|B2|Baseline|Placebo Lens|contact lens without drug
972256|NCT00889252|B1|Baseline|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972257|NCT00889252|P2|Participant Flow|Placebo Lens|contact lens without drug
972258|NCT00889252|P1|Participant Flow|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972259|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972260|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972261|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972262|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972263|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972264|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972268|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972269|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972270|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972274|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972275|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972276|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972277|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972278|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972279|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972280|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972281|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972282|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972283|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972284|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972285|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972286|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972287|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972288|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972289|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972290|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972291|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972292|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972293|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972294|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972295|NCT00889252|O2|Outcome|Placebo Lens|contact lens without drug
972296|NCT00889252|O1|Outcome|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972297|NCT00889252|E2|Reported Event|Placebo Lens|contact lens without drug
972298|NCT00889252|E1|Reported Event|K-Lens|Ketotifen combination drug-device product: contact lens (device) and anti-allergy drug
972299|NCT00889200|B1|Baseline|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
972300|NCT00889200|P1|Participant Flow|Open-label Eszopiclone|"Standard daily dosing of 3 mg drug nightly for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
972301|NCT00889200|O1|Outcome|Open-label Eszopiclone|After Standard dosing of drug for 6 weeks for insomnia, Dex/CRH test was repeated to measure cortisol reactivity with the same neuroendocrine test
972302|NCT00889200|E1|Reported Event|Open-label Eszopiclone|"Standard dosing of drug for 6 weeks for insomnia~eszopiclone : 6 weeks standard oral therapy"
972303|NCT00888979|B1|Baseline|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
972304|NCT00888979|P1|Participant Flow|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
972305|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
972306|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
972307|NCT00888979|O1|Outcome|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
972308|NCT00888979|E1|Reported Event|Nicotrol Inhaler With Behavioral Counseling|Nicotrol Inhaler: 10 mg of nicotine per one inhaler cartridge. Inhaler use will substitute the usual smoking pattern
972309|NCT00888654|B1|Baseline|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
972310|NCT00888654|P1|Participant Flow|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
972311|NCT00888654|O1|Outcome|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
972312|NCT00888654|E1|Reported Event|B-Dim, Radical Prosatectomy|"B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prostatectomy~B-Dim: B-DIM 225 mg orally twice daily x 14-72 days (based on scheduling of surgery)~Radical Prosatectomy"
972313|NCT00888628|B1|Baseline|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
972422|NCT00888329|O2|Outcome|Placebo|Placebo
972314|NCT00888628|P1|Participant Flow|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
972315|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
972316|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
972317|NCT00888628|O1|Outcome|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
972318|NCT00888628|E1|Reported Event|Islet Transplant|"Patients will receive (an) infusion(s) of in vitro cultured islets with the goal of achieving insulin independence.~For the first islet transplant, patients will receive induction therapy with rabbit anti-thymocyte globulin (ATG, 5 doses) and will remain on their maintenance immunosuppression regimen already in place for their renal allograft.~Induction therapy for subsequent transplants will be 2 doses of basiliximab.~All patients will receive Etanercept to promote engraftment.~Purified Pancreatic Islets: Islet after kidney transplant in patients with type I diabetes.~Etanercept: Given as induction for islet cell transplant"
972319|NCT00888459|B3|Baseline|Total|Total of all reporting groups
972320|NCT00888459|B2|Baseline|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
972321|NCT00888459|B1|Baseline|Active|4 mg nicotine lozenges
972322|NCT00888459|P2|Participant Flow|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
972323|NCT00888459|P1|Participant Flow|Active|4 mg nicotine lozenges
972324|NCT00888459|O2|Outcome|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
972325|NCT00888459|O1|Outcome|Active|4 mg nicotine lozenges
972326|NCT00888459|E2|Reported Event|Placebo|placebo nicotine lozenges (similar in appearance to the 4 mg lozenge)
972327|NCT00888459|E1|Reported Event|Active|4 mg nicotine lozenges
972328|NCT00888433|B3|Baseline|Total|Total of all reporting groups
972329|NCT00888433|B2|Baseline|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
972330|NCT00888433|B1|Baseline|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
972331|NCT00888433|P2|Participant Flow|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
972332|NCT00888433|P1|Participant Flow|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
972333|NCT00888433|O2|Outcome|Control|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
972334|NCT00888433|O1|Outcome|Renal Denervation|Renal Denervation and maintenance of anti-hypertensive medications
972335|NCT00888433|E2|Reported Event|2. CONTROL|Maintenance of anti-hypertensive medications with option for cross-over treatment after 6-months
972336|NCT00888433|E1|Reported Event|1. DENERVATION|Renal Denervation and maintenance of anti-hypertensive medications
972337|NCT00888381|B3|Baseline|Total|Total of all reporting groups
972338|NCT00888381|B2|Baseline|Older Adults|Healthy volunteers aged 60 years or older
972339|NCT00888381|B1|Baseline|Adults|Healthy volunteers aged 18 to 59 years
972340|NCT00888381|P2|Participant Flow|Older Adults|Healthy volunteers aged 60 years or older
972341|NCT00888381|P1|Participant Flow|Adults|Healthy volunteers aged 18 to 59 years
972342|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
972343|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
972344|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
972345|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
972346|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
972347|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
972348|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
972349|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
972350|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
972351|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
972352|NCT00888381|O2|Outcome|Older Adults|Healthy volunteers aged 60 years or older
972353|NCT00888381|O1|Outcome|Adults|Healthy volunteers aged 18 to 59 years
972354|NCT00888381|E2|Reported Event|Older Adults|Healthy volunteers aged 60 years or older
972355|NCT00888381|E1|Reported Event|Adults|Healthy volunteers aged 18 to 59 years
972357|NCT00888355|B4|Baseline|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972358|NCT00888355|B3|Baseline|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972359|NCT00888355|B2|Baseline|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972360|NCT00888355|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
972361|NCT00888355|P4|Participant Flow|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972478|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972362|NCT00888355|P3|Participant Flow|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972363|NCT00888355|P2|Participant Flow|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972364|NCT00888355|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
972365|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972366|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972367|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972368|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972369|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972370|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972371|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972372|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972373|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972374|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972375|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972376|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972377|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972378|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972379|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972380|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972381|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972382|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972383|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972384|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972385|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972386|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972387|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972388|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972389|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972390|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972391|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972392|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972393|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972394|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972395|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972396|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972397|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972398|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972399|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972400|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972401|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972402|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972403|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972404|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972405|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972406|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972407|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972408|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972409|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972410|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972411|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972412|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972413|NCT00888355|O4|Outcome|Losartan 25 mg (b.i.d.)|Losartan 25 mg orally twice daily (b.i.d.) for 12 weeks
972414|NCT00888355|O3|Outcome|Losartan 50 mg q.d.|Losartan 50 mg orally once daily (q.d.) for 12 weeks
972415|NCT00888355|O2|Outcome|Losartan 25 mg q.d.|Losartan 25 mg orally once daily (q.d.) for 12 weeks
972416|NCT00888355|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972417|NCT00888329|B3|Baseline|Total|Total of all reporting groups
972418|NCT00888329|B2|Baseline|Placebo|Placebo
972419|NCT00888329|B1|Baseline|Aprepitant|40 mg aprepitant
972420|NCT00888329|P2|Participant Flow|Placebo|Placebo
972427|NCT00888238|P3|Participant Flow|Placebo / Sitagliptin / Sitagliptin|Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
972428|NCT00888238|P2|Participant Flow|Sitagliptin / Placebo / Sitagliptin|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet)
972479|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972429|NCT00888238|P1|Participant Flow|Sitagliptin / Sitagliptin / Placebo|Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Single oral dose Sitagliptin 100 mg (administered as 2 X 50 mg tablet) / Matching Placebo
972430|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
972431|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
972432|NCT00888238|O2|Outcome|Placebo|12 subjects received a single-dose of placebo in 1 period.
972433|NCT00888238|O1|Outcome|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
972434|NCT00888238|E2|Reported Event|Placebo|12 subjects received a single-dose of placebo in 1 period.
972435|NCT00888238|E1|Reported Event|Sitagliptin 100 mg|11 subjects received a single-dose of sitagliptin 100 mg in 2 periods; 1 subject received a single dose of sitagliptin 100 mg in 1 period only.
972436|NCT00888134|B1|Baseline|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
972437|NCT00888134|P1|Participant Flow|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
972438|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
972439|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Selumetinib: Given PO"
972440|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
972441|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
972442|NCT00888134|O1|Outcome|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
972443|NCT00888134|E1|Reported Event|Treatment (Selumetinib)|"Patients receive selumetinib PO BID for 3 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Given PO"
972444|NCT00887978|B3|Baseline|Total|Total of all reporting groups
972445|NCT00887978|B2|Baseline|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
972446|NCT00887978|B1|Baseline|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
972447|NCT00887978|P2|Participant Flow|Placebo|Identical placebo tablets to UT-15C, doses were titrated in the same manner
972448|NCT00887978|P1|Participant Flow|UT-15C SR|Doses were initiated at 0.25 mg BID and increased by 0.25 mg BID every three days (as clinically indicated based on tolerability and symptoms of PAH), to a max dose of 16 mg BID.
972449|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972450|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972451|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972452|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972453|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972454|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972455|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972456|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972457|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972458|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972459|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972460|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972461|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972462|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972463|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972464|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972465|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972466|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972467|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972468|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972469|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972470|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972471|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972472|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972474|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972475|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972476|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972477|NCT00887978|O2|Outcome|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1mg (3.6).
972480|NCT00887978|O1|Outcome|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1mg (1.9).
972481|NCT00887978|E2|Reported Event|Placebo|At Week 16, the mean(SD) dose of placebo was 6.1 (3.6).
972482|NCT00887978|E1|Reported Event|UT-15C SR|At Week 16, the mean(SD) dose of UT-15C was 3.1 (1.9).
972483|NCT00887965|B1|Baseline|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972484|NCT00887965|P1|Participant Flow|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972485|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972486|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972487|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972488|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972489|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972490|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972491|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972492|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972493|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972494|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972495|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972496|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972497|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972498|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972499|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972500|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972501|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972502|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972503|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972504|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972505|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972506|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972507|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972508|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972509|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972510|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972511|NCT00887965|O1|Outcome|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972512|NCT00887965|E1|Reported Event|Previous Denosumab|Participants who had previously received Denosumab 60 mg every 6 months and had transiliac bone biopsy.
972513|NCT00887913|B1|Baseline|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
972514|NCT00887913|P1|Participant Flow|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
972515|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
972516|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
972517|NCT00887913|O1|Outcome|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
972518|NCT00887913|E1|Reported Event|Treatment|Treatment group- undergo 3 treatments every 4-6 weeks
972519|NCT00887822|B3|Baseline|Total|Total of all reporting groups
972520|NCT00887822|B2|Baseline|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972689|NCT00887510|B3|Baseline|Total|Total of all reporting groups
972772|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
972521|NCT00887822|B1|Baseline|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972691|NCT00887510|B1|Baseline|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
972522|NCT00887822|P2|Participant Flow|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972523|NCT00887822|P1|Participant Flow|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenous (IV) infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972524|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972525|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972526|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972527|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972528|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972529|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972530|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972531|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972532|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972533|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972534|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972535|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972536|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972537|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972773|NCT00887471|E2|Reported Event|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
972538|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972539|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972540|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972541|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972542|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972543|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972544|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972545|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972546|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972547|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972548|NCT00887822|O2|Outcome|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972549|NCT00887822|O1|Outcome|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972550|NCT00887822|E2|Reported Event|Placebo, Capecitabine and Cisplatin|Participants received placebo matched to bevacizumab on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972551|NCT00887822|E1|Reported Event|Bevacizumab, Capecitabine and Cisplatin|Participants received bevacizumab 7.5 mg/kg IV infusion on Day 1 of every 3-week cycle in combination with capecitabine 1000 mg/m^2 orally twice daily (total daily dose 2000 mg/m^2) on Days 1-14 of every 3-week cycle and cisplatin 80 mg/m^2 IV infusion on Day 1 of every 3-week cycle for a maximum of 6 cycles; until disease progression or unmanageable toxicity.
972552|NCT00887809|B3|Baseline|Total|Total of all reporting groups
972553|NCT00887809|B2|Baseline|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
972554|NCT00887809|B1|Baseline|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
972555|NCT00887809|P2|Participant Flow|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
972556|NCT00887809|P1|Participant Flow|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
972557|NCT00887809|O2|Outcome|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
972558|NCT00887809|O1|Outcome|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
972559|NCT00887809|E2|Reported Event|Gemcitabine, Docetaxel, Placebo|Gemcitabine, Docetaxel, Placebo
972560|NCT00887809|E1|Reported Event|Gemcitabine, Docetaxel, Bevacizumab|Gemcitabine, Docetaxel, Bevacizumab
972561|NCT00887744|B1|Baseline|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
972562|NCT00887744|P1|Participant Flow|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication.
972871|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972563|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
972564|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
972565|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
972566|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
972567|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
972568|NCT00887744|O1|Outcome|Aperius® Treatment Arm|The targetted patient population -intended to be treated with the Aperius® Percutaneous Interspinous Spacer- is subjects with degenerative lumbar spinal stenosis with symptomatic neurogenic intermittent claudication. The Aperius is a device will be inserted at day 0 (surgery date). Normally no additional manipulations are needed once the device(s) are inserted into the body.
972569|NCT00887744|E1|Reported Event|ITT Analysis|Single group - Aperius
972570|NCT00887679|B1|Baseline|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972571|NCT00887679|P1|Participant Flow|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972572|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972573|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972574|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972575|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972576|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972577|NCT00887679|O1|Outcome|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Subjects received escitalopram 10-20mg. Escitalopram was started at 10 mg per day and augmented weekly in 10 mg per day increments, the maximum dose being 20 mg per day.
972578|NCT00887679|E1|Reported Event|Escitalopram|Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.
972579|NCT00887653|B1|Baseline|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
972580|NCT00887653|P1|Participant Flow|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
972581|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
972582|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
972583|NCT00887653|O1|Outcome|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
972584|NCT00887653|E1|Reported Event|Raltegravir Arm|"This is a single arm study where HIV-infected individuals virologically suppressed on current regimen will be switched to raltegravir +optimized back ground regimen for 6 months~raltegravir: This will be a single arm study where subjects will be given the option to switch from their current regimen to raltegravir at 400mg twice daily."
972585|NCT00887640|B1|Baseline|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972690|NCT00887510|B2|Baseline|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
972692|NCT00887510|P2|Participant Flow|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
972586|NCT00887640|P1|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972587|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972588|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972589|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972590|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972591|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972592|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972593|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972594|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972595|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972596|NCT00887640|O1|Outcome|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972597|NCT00887640|E1|Reported Event|Temsirolimus 25 mg|Temsirolimus 25mg was administered by IV infusion each week (days 1, 8, 15, and 22 of each 28 day cycle). The infusion was to be administered over a period not less than 30 minutes and was to be completed within 60 minutes. Subjects were premedicated with 25 to 50 mg IV or PO diphenhydramine (or an alternative antihistamine in case of allergies) 30 minutes prior to the infusion.
972598|NCT00887588|B3|Baseline|Total|Total of all reporting groups
972599|NCT00887588|B2|Baseline|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972600|NCT00887588|B1|Baseline|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972601|NCT00887588|P2|Participant Flow|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972602|NCT00887588|P1|Participant Flow|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972603|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972604|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972726|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972980|NCT00886834|B3|Baseline|Total|Total of all reporting groups
972605|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972606|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972607|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972608|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972609|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972610|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972611|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972612|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972613|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972614|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972615|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972616|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972617|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972618|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972619|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972620|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972621|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972622|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972623|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972624|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972625|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972626|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972627|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972628|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972629|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972630|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972631|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972632|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972633|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972634|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972635|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972636|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972637|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972638|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972639|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972640|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972641|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972642|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972643|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972644|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972645|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972646|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972647|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972648|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972649|NCT00887588|O2|Outcome|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972650|NCT00887588|O1|Outcome|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972651|NCT00887588|E2|Reported Event|Valsartan|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 40 mg Valsartan twice daily (bid) for 1 - 2 weeks, then were uptitrated to 80 mg bid for 1 -2 weeks, and thereafter, uptitrated to 160 mg bid.
972652|NCT00887588|E1|Reported Event|LCZ696|During a single blind, run-in period, participants received placebo. Then at randomization (double blind treatment period), participants started with 50 mg LCZ696 for 1- 2 weeks, then uptitrated to 100 mg bid for 1 -2 weeks, and thereafter, uptitrated to 200 mg bid.
972653|NCT00887575|B1|Baseline|All Patients|Includes all patients treated at all dose levels
972654|NCT00887575|P3|Participant Flow|Dose Level III|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 6) day 1 of every cycle and Sunitinib PO (25mg) daily.
972655|NCT00887575|P2|Participant Flow|Dose Level II|Paclitaxel IV (80 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.
972656|NCT00887575|P1|Participant Flow|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
972657|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
972658|NCT00887575|O1|Outcome|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
972659|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
972660|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
972661|NCT00887575|O1|Outcome|Phase II- Sunitinib/Paclitaxel/Carboplatin|Systemic Therapy based on maximum tolerated dose (MTD) of the Phase I portion
972662|NCT00887575|E1|Reported Event|Dose Level I|"Neoadjuvant - Paclitaxel IV (70 mg/m^2) days 1, 8 and 15 of each cycle, Carboplatin IV (AUC = 5) day 1 of every cycle and Sunitinib PO (25mg) daily.~Maintenance - Sunitinib PO (25mg) daily"
972663|NCT00887562|B4|Baseline|Total|Total of all reporting groups
972664|NCT00887562|B3|Baseline|Placebo|"Placebo~Placebo: Placebo - No idebenone"
972665|NCT00887562|B2|Baseline|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
972666|NCT00887562|B1|Baseline|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
972667|NCT00887562|P3|Participant Flow|Placebo|"Placebo~Placebo: Placebo - No idebenone"
972668|NCT00887562|P2|Participant Flow|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
972669|NCT00887562|P1|Participant Flow|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
972670|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
972671|NCT00887562|O2|Outcome|2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
972672|NCT00887562|O1|Outcome|900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
972673|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
972674|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
972675|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
972676|NCT00887562|O3|Outcome|Placebo|"Placebo~Placebo: Placebo - No idebenone"
972677|NCT00887562|O2|Outcome|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
972678|NCT00887562|O1|Outcome|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
972679|NCT00887562|E3|Reported Event|Placebo|"Placebo~Placebo: Placebo - No idebenone"
972680|NCT00887562|E2|Reported Event|Idebenone 2250 mg/Day|"Idebenone 2250 mg/day~Idebenone: 2250 mg/day for one month"
972681|NCT00887562|E1|Reported Event|Idebenone 900 mg/Day|"Idebenone 900 mg/day~Idebenone: 900 mg/day for 1 month"
972682|NCT00887549|B1|Baseline|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
972683|NCT00887549|P1|Participant Flow|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
972684|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
972685|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
972686|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
972687|NCT00887549|O1|Outcome|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
972688|NCT00887549|E1|Reported Event|Pemetrexed|Induction Therapy: pemetrexed 500 milligrams per square meter (mg/m^2) and cisplatin 75 mg/m^2, intravenous, day 1 of each 21 day cycle for the first 4 cycles; Maintenance Therapy: pemetrexed 500 milligrams per square meter (mg/m^2), intravenous, day 1 of each 21 day cycle until progression or unacceptable toxicity occurs
972693|NCT00887510|P1|Participant Flow|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
972694|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
972695|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
972696|NCT00887510|O2|Outcome|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
972697|NCT00887510|O1|Outcome|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
972698|NCT00887510|E2|Reported Event|Trandolapril First|Participants will receive 4 mg of trandolapril each day for 6 weeks, followed by 4 mg of trandolapril for 6 weeks plus 25 mg of HCTZ each day for 6 weeks, followed by 25 mg of HCTZ each day for 6 weeks.
972699|NCT00887510|E1|Reported Event|Thiazide First|Participants will receive 25 mg of hydrochlorothiazide (HCTZ) each day for 6 weeks, followed by 25 mg of HCTZ every day plus 4 mg of trandolapril each day for 6 weeks, followed by 4 mg trandolapril each day for 6 weeks.
972700|NCT00887484|B1|Baseline|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
972701|NCT00887484|P1|Participant Flow|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
972702|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
972703|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972704|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972705|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
972706|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972707|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972708|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
972709|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972710|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972711|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
972712|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972713|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972714|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
972715|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972716|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972717|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to the entire face once-daily in the evening.
972718|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972719|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972720|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972721|NCT00887484|O1|Outcome|All Subjects|Subjects applied both study products in a split-face fashion through week 2. Study products were applied once-daily in the evening.
972722|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972723|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972724|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972725|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
973284|NCT00886704|B2|Baseline|Convenience Drink Without EPA and DHA|
972727|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972728|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972729|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972730|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972731|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972732|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972733|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972734|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972735|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972736|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972737|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972738|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972739|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972740|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972741|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972742|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972743|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972744|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972745|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972746|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972747|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972748|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972749|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972750|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972751|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972752|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972753|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972754|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972755|NCT00887484|O2|Outcome|Epiduo|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972756|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972757|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972758|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972759|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972760|NCT00887484|O1|Outcome|Clindoxyl Gel|Subjects applied Clindoxyl gel to their entire face once-daily in the evening.
972761|NCT00887484|O2|Outcome|Epiduo Gel|Epiduo gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972762|NCT00887484|O1|Outcome|Clindoxyl Gel|Clindoxyl gel was applied to one side of the face in a randomized fashion. This study product was applied once-daily in the evening.
972763|NCT00887484|E1|Reported Event|Clindoxyl and Epiduo Gels|Commencing at baseline, participants will apply clindoxyl and epiduo gels once daily in a bilateral split-face fashion (Split Face Treatment Period; allocation to left and right side randomly assigned) for an initial 2 weeks. At Week 5, during the Full Face Treatment Period, participants will apply clindoxyl gel to the entire face for an additional 4 weeks.
972764|NCT00887471|B3|Baseline|Total|Total of all reporting groups
972765|NCT00887471|B2|Baseline|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
972766|NCT00887471|B1|Baseline|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
972767|NCT00887471|P2|Participant Flow|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
972768|NCT00887471|P1|Participant Flow|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
972769|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
972770|NCT00887471|O1|Outcome|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
972771|NCT00887471|O2|Outcome|Children Who Underwent T&A|Children who underwent total tonsillectomy and adenoidectomy.
972774|NCT00887471|E1|Reported Event|Children Who Underwent PITA|Children who underwent partial intracapsular tonsillectomy and adenoidectomy.
972775|NCT00887458|B3|Baseline|Total|Total of all reporting groups
972776|NCT00887458|B2|Baseline|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
1025158|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
972777|NCT00887458|B1|Baseline|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
972778|NCT00887458|P2|Participant Flow|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
972779|NCT00887458|P1|Participant Flow|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
972780|NCT00887458|O2|Outcome|High Dose Itraconazole|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
972781|NCT00887458|O1|Outcome|Low Dose Itraconazole|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
972782|NCT00887458|E2|Reported Event|High Dose|"Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)~Itraconazole 300mg: Itraconazole, 300 mg, by mouth, twice daily (600 mg total daily dose)"
972783|NCT00887458|E1|Reported Event|Low Dose|"Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)~Itraconazole 200 mg: Itraconazole, 200 mg, by mouth, once daily (200 mg total daily dose)"
972784|NCT00887354|B3|Baseline|Total|Total of all reporting groups
972785|NCT00887354|B2|Baseline|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972786|NCT00887354|B1|Baseline|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972787|NCT00887354|P2|Participant Flow|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972788|NCT00887354|P1|Participant Flow|Teriparatide|"20 microgram (mcg) a day by subcutaneous (SC) injection throughout study.~Calcium: Approximately 500 to 1000 milligram per day (mg/day) administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972789|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972790|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972791|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972792|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972793|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972794|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972795|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972796|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972797|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972798|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972799|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972800|NCT00887354|O1|Outcome|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972801|NCT00887354|O2|Outcome|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972802|NCT00887354|O1|Outcome|Teriparatide|"20 mg per day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
973285|NCT00886704|B1|Baseline|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
972803|NCT00887354|E2|Reported Event|Risedronate|"35 mg risedronate sodium orally once weekly throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972981|NCT00886834|B2|Baseline|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
972804|NCT00887354|E1|Reported Event|Teriparatide|"20 mcg a day by SC injection throughout study.~Calcium: Approximately 500 to 1000 mg/day administered orally throughout study.~Vitamin D: Approximately 800 International Units per day (IU/day) administered orally throughout study."
972805|NCT00887341|B3|Baseline|Total|Total of all reporting groups
972806|NCT00887341|B2|Baseline|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972807|NCT00887341|B1|Baseline|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972808|NCT00887341|P2|Participant Flow|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972809|NCT00887341|P1|Participant Flow|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972810|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972811|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972812|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972813|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972814|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972815|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972816|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972817|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972818|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972819|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972820|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972821|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972822|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972823|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972824|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972825|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972826|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972827|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972869|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972870|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972828|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972829|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972830|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972831|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972832|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972833|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972834|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972835|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972836|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972837|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972838|NCT00887341|O2|Outcome|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972839|NCT00887341|O1|Outcome|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972840|NCT00887341|E2|Reported Event|Tocilizumab, 31 Minute Infusions|Participants received tocilizumab 8 mg/kg via IV infusion, once every 4 weeks for 6 infusions (up to 24 weeks). The first infusion was 1 hour; the remaining 5 infusions were administered over a period of 31 minutes as long as no infusion reactions occurred. If an infusion reaction occurred, 1 hour infusions were used for all subsequent remaining infusions.
972841|NCT00887341|E1|Reported Event|Tocilizumab, 1 Hour Infusions|Participants received tocilizumab 8 mg/kg via IV infusion (over 1 hour), once every 4 weeks for 6 infusions (up to 24 weeks).
972842|NCT00887315|B3|Baseline|Total|Total of all reporting groups
972843|NCT00887315|B2|Baseline|Chemo and Radiation|Chemotherapy and radiotherapy
972844|NCT00887315|B1|Baseline|Chemo Only|Chemotherapy only
972845|NCT00887315|P2|Participant Flow|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
972846|NCT00887315|P1|Participant Flow|Chemo Only|Chemotherapy only
972847|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
972848|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
972849|NCT00887315|O2|Outcome|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
972850|NCT00887315|O1|Outcome|Chemo Only|Chemotherapy only
972851|NCT00887315|E2|Reported Event|Chemo and Radiation|Chemotherapy and hypofractionated image guided radiotherapy
972852|NCT00887315|E1|Reported Event|Chemo Only|Chemotherapy only
972853|NCT00887289|B1|Baseline|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972854|NCT00887289|P1|Participant Flow|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972855|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972856|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972857|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972858|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972859|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972860|NCT00887289|O1|Outcome|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972861|NCT00887289|E1|Reported Event|Pramipexole|0.088 mg every day (qd), titration up to 0.54 mg qd possible
972862|NCT00887250|B4|Baseline|Total|Total of all reporting groups
972863|NCT00887250|B3|Baseline|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972864|NCT00887250|B2|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972865|NCT00887250|B1|Baseline|Placebo|Losartan placebo orally once daily for 12 weeks
972866|NCT00887250|P3|Participant Flow|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972867|NCT00887250|P2|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972868|NCT00887250|P1|Participant Flow|Placebo|Losartan placebo orally once daily for 12 weeks
972872|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972873|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972874|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972875|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972876|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972877|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972878|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972879|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972880|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972881|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972882|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972883|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972884|NCT00887250|O3|Outcome|Losartan 50/100 mg|Losartan orally once daily for 12 weeks, initiated as 50 mg and titrated to 100 mg for nonresponders (SiDBP ≥90 mm Hg) after 6 weeks
972885|NCT00887250|O2|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 12 weeks
972886|NCT00887250|O1|Outcome|Placebo|Losartan placebo orally once daily for 12 weeks
972887|NCT00887224|B4|Baseline|Total|Total of all reporting groups
972888|NCT00887224|B3|Baseline|DVS SR 50 mg (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population)."
972889|NCT00887224|B2|Baseline|Placebo (Double-blind Phase)|"Eligible participants from OL Phase were randomized in a 1:1 ratio to either Placebo or DVS SR in the DB Phase.~Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population)."
972890|NCT00887224|B1|Baseline|DVS SR 50 mg (Open-label Phase)|DVS SR 50 mg PO QD for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
972891|NCT00887224|P3|Participant Flow|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD (All Randomized Population).
972892|NCT00887224|P2|Participant Flow|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD (All Randomized Population).
972893|NCT00887224|P1|Participant Flow|DVS SR 50 mg (Open-label Phase)|Desvenlafaxine succinate sustained release (DVS SR) 50 milligrams (mg) by mouth (PO) once daily (QD) for 20 weeks (Days 1 to 140). This included an 8-week response phase and for responders at Week 8, a 12-week stability phase. Participants who concluded open-label study or discontinued treatment received DVS SR 25 mg PO QD for 7-day taper period (All Enrolled Population).
972894|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972895|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972896|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972897|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972898|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972899|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972900|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972901|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972902|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972903|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972904|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972905|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972906|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD..
972982|NCT00886834|B1|Baseline|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
972907|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972908|NCT00887224|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972909|NCT00887224|O1|Outcome|Placebo|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972910|NCT00887224|E7|Reported Event|DVS SR 50 mg (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued DVS SR 50 mg during the DB phase could have entered the taper phase and received DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
972911|NCT00887224|E6|Reported Event|Placebo (DB Taper / DB Post Study Follow Up)|Participants who concluded or discontinued placebo during the DB phase could have entered the taper phase and received placebo matching DVS SR 25 mg for a 7-day period of taper treatment. N=number of participants with DB Taper or DB Post Study Follow Up emergent events who concluded or discontinued with or without taper treatment.
972912|NCT00887224|E5|Reported Event|DVS SR 50 mg (Double-blind Phase)|DVS SR 50 mg and placebo matching DVS SR 25 mg PO QD Days 141 to 147; DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with DVS SR 25 mg PO QD.
972913|NCT00887224|E4|Reported Event|Placebo (Double-blind Phase)|Placebo matching DVS SR 50 mg and DVS SR 25 mg PO QD Days 141 to 147, then placebo matching DVS SR 50 mg PO QD Days 148 to 322 followed by 7-day taper period with placebo matching DVS SR 25 mg PO QD.
972914|NCT00887224|E3|Reported Event|DVS SR 50 mg (Open Label Taper / OL Post Study Follow Up)|Participants who concluded DVS SR 50 mg open-label study or discontinued treatment at any time in OLR or OLS could have entered the taper phase and received DVS SR 25 mg PO QD for a 7-day period of taper treatment. N=number of participants with OL Taper or OL Post Study Follow Up emergent events who did not enter the DB Phase and concluded or discontinued with or without taper treatment.
972915|NCT00887224|E2|Reported Event|DVS SR 50 mg (Open Label Stability Phase)|DVS SR 50 mg PO QD; Responders at week 8 entered a 12-week stability phase.
972916|NCT00887224|E1|Reported Event|DVS SR 50 mg (Open-label Response Phase)|DVS SR 50 mg PO QD for 8 weeks.
972917|NCT00887198|B3|Baseline|Total|Total of all reporting groups
972918|NCT00887198|B2|Baseline|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972919|NCT00887198|B1|Baseline|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972920|NCT00887198|P2|Participant Flow|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972921|NCT00887198|P1|Participant Flow|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972922|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972923|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972924|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972925|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972926|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972927|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972928|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972929|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972930|NCT00887198|O3|Outcome|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
972983|NCT00886834|P2|Participant Flow|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
973601|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
972931|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972932|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972933|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972934|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972935|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972936|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972937|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972938|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972939|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972940|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972941|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972942|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972943|NCT00887198|O2|Outcome|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972944|NCT00887198|O1|Outcome|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972945|NCT00887198|E3|Reported Event|Placebo to Abiraterone Acetate|Participants received initially placebo along with prednisone 5 mg tablet, orally, later on switched to 1,000 milligram (mg) abiraterone acetate tablet (as 4*250 mg tablets) along with prednisone 5 mg tablet due to disease progression.
972946|NCT00887198|E2|Reported Event|Placebo|Participants received placebo matched to abiraterone acetate tablets orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972947|NCT00887198|E1|Reported Event|Abiraterone Acetate|Participants received 1000 milligram (mg) abiraterone acetate tablets (as 4*250 mg tablets) orally once daily along with prednisone 5 mg tablet orally twice daily, from Day 1, Cycle1 (each cycle consist of 28 days) up to radiographic progression of disease and/or unequivocal clinical progression.
972948|NCT00887159|B4|Baseline|Total|Total of all reporting groups
972949|NCT00887159|B3|Baseline|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
972950|NCT00887159|B2|Baseline|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
972951|NCT00887159|B1|Baseline|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
972952|NCT00887159|P3|Participant Flow|Arm C (CE+IMC-A12)|"Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~cisplatin: Given IV~etoposide: Given IV"
972953|NCT00887159|P2|Participant Flow|Arm B (CE+GDC-0449)|"Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.~vismodegib: Given PO~cisplatin: Given IV~etoposide: Given IV"
972954|NCT00887159|P1|Participant Flow|Arm A (CE)|"Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.~cisplatin: Given IV~etoposide: Given IV"
972955|NCT00887159|O2|Outcome|Low CTC Count|Low CTC count is defined as <= 100 CTCs per 7.5 ml at baseline.
972956|NCT00887159|O1|Outcome|High CTC Count|High CTC count is defined as greater than 100 CTCs per 7.5 ml at baseline.
972957|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
972958|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
972959|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
972960|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
972961|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
972962|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
972963|NCT00887159|O3|Outcome|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
972964|NCT00887159|O2|Outcome|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
972965|NCT00887159|O1|Outcome|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
972966|NCT00887159|E3|Reported Event|Arm C (CE+IMC-A12)|Patients receive cisplatin and etoposide as in Arm A and cixutumumab (IMC-A12; 6 mg/kg) IV over 1 hour on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive cixutumumab alone once weekly in the absence of disease progression or unacceptable toxicity.
972967|NCT00887159|E2|Reported Event|Arm B (CE+GDC-0449)|Patients receive cisplatin and etoposide as in Arm A and vismodegib (GDC-0449; 150 mg tablet) orally (PO) once daily (QD) on days 1-21. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive vismodegib alone QD in the absence of disease progression or unacceptable toxicity.
972968|NCT00887159|E1|Reported Event|Arm A (CE)|Patients receive cisplatin (75 mg/m2) intravenously (IV) over 1-2 hours on day 1 and etoposide (100 mg/m2) IV over 1-2 hours on days 1-3. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
972969|NCT00886938|B1|Baseline|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
972970|NCT00886938|P1|Participant Flow|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
972971|NCT00886938|O1|Outcome|rTMS|rTMS to the left dorsolateral prefrontal cortex for patients with tinnitus
972972|NCT00886938|E1|Reported Event|rTMS|rTMS to the dorsolateral prefrontal cortex for patients with tinnitus. Treated at 110% of Motor Threshold
972973|NCT00886899|B1|Baseline|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
972974|NCT00886899|P1|Participant Flow|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
972975|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
972976|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
972977|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
972978|NCT00886899|O1|Outcome|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
972979|NCT00886899|E1|Reported Event|BridgePoint Medical System|Attempt to cross CTO with the BridgePoint Medical System after an attempt to cross the CTO with a currently marketed guidewire
972984|NCT00886834|P1|Participant Flow|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
972985|NCT00886834|O2|Outcome|Placebo|
972986|NCT00886834|O1|Outcome|Misoprostol|
972987|NCT00886834|O2|Outcome|Placebo|
972988|NCT00886834|O1|Outcome|Misoprostol|
972989|NCT00886834|E2|Reported Event|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
972990|NCT00886834|E1|Reported Event|Misoprostol|Misoprostol 400 micrograms inserted vaginally or buccally, per the participants desire.
972991|NCT00886821|B15|Baseline|Total|Total of all reporting groups
972992|NCT00886821|B14|Baseline|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
972993|NCT00886821|B13|Baseline|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
972994|NCT00886821|B12|Baseline|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
972995|NCT00886821|B11|Baseline|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
972996|NCT00886821|B10|Baseline|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or two dose on Day 1 and 8 respectively.
972997|NCT00886821|B9|Baseline|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
972998|NCT00886821|B8|Baseline|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
972999|NCT00886821|B7|Baseline|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973000|NCT00886821|B6|Baseline|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973001|NCT00886821|B5|Baseline|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973002|NCT00886821|B4|Baseline|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973003|NCT00886821|B3|Baseline|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973004|NCT00886821|B2|Baseline|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973005|NCT00886821|B1|Baseline|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973006|NCT00886821|P14|Participant Flow|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973007|NCT00886821|P13|Participant Flow|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973008|NCT00886821|P12|Participant Flow|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973009|NCT00886821|P11|Participant Flow|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973010|NCT00886821|P10|Participant Flow|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973011|NCT00886821|P9|Participant Flow|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973012|NCT00886821|P8|Participant Flow|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973013|NCT00886821|P7|Participant Flow|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973014|NCT00886821|P6|Participant Flow|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973015|NCT00886821|P5|Participant Flow|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973016|NCT00886821|P4|Participant Flow|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973017|NCT00886821|P3|Participant Flow|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973018|NCT00886821|P2|Participant Flow|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973019|NCT00886821|P1|Participant Flow|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973020|NCT00886821|O4|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973021|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973022|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973023|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973024|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973025|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973026|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973027|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973028|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973029|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973030|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973290|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|Palatability
973031|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973032|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973033|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973034|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973035|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973036|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973037|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973038|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973039|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973040|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973041|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973042|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973043|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973044|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973045|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973046|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973047|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973048|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973049|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973050|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973051|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973052|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973053|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973054|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973055|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973056|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973057|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973058|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973059|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973060|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973061|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973062|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973063|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973064|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973065|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973066|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973067|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973068|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973069|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973070|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973071|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973072|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973073|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973074|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973075|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973076|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973077|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973078|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973079|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973080|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973081|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973082|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973083|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973084|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973085|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973086|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973087|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973088|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973089|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973090|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973091|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973092|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973093|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973094|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973095|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973096|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973097|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973098|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973099|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973100|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973101|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973102|NCT00886821|O15|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973103|NCT00886821|O14|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973104|NCT00886821|O13|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973105|NCT00886821|O12|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973106|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973107|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973108|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973109|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973110|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973111|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973112|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973113|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973114|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973115|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973116|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973117|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973286|NCT00886704|P2|Participant Flow|Convenience Drink Without EPA and DHA|
973118|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973119|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973120|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973121|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973122|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973123|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973124|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973125|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973126|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973127|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973128|NCT00886821|O11|Outcome|Cohort 9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973129|NCT00886821|O10|Outcome|Cohort 1-8: Combined Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 3, 7.
973130|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973131|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973132|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973133|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973134|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973135|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973136|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973137|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973138|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973139|NCT00886821|O14|Outcome|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973140|NCT00886821|O13|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973141|NCT00886821|O12|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973142|NCT00886821|O11|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973143|NCT00886821|O10|Outcome|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973144|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973145|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973146|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973147|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973148|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973149|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973150|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973151|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973152|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973153|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973154|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973155|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973156|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973157|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973158|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973159|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973160|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973161|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973162|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973287|NCT00886704|P1|Participant Flow|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
973163|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973164|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973165|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973166|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973167|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973168|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973169|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973170|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973171|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973172|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973173|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973174|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973175|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973176|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973177|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973178|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973179|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973180|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973181|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973182|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973183|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973184|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973185|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973186|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973187|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973188|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973189|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973190|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973191|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973192|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973193|NCT00886821|O12|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973194|NCT00886821|O11|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973195|NCT00886821|O10|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973196|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973197|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973198|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973199|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973200|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973201|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973202|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973203|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973204|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973205|NCT00886821|O3|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973206|NCT00886821|O2|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973207|NCT00886821|O1|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973208|NCT00886821|O1|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973209|NCT00886821|O12|Outcome|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973210|NCT00886821|O11|Outcome|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973211|NCT00886821|O10|Outcome|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973212|NCT00886821|O9|Outcome|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973213|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973214|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973215|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973216|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973217|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973218|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973219|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973220|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973221|NCT00886821|O8|Outcome|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973222|NCT00886821|O7|Outcome|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973223|NCT00886821|O6|Outcome|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973224|NCT00886821|O5|Outcome|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973225|NCT00886821|O4|Outcome|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973226|NCT00886821|O3|Outcome|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973227|NCT00886821|O2|Outcome|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973228|NCT00886821|O1|Outcome|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973229|NCT00886821|E14|Reported Event|Cohort 10-12: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection on Day 1, 8, 15 and 22.
973230|NCT00886821|E13|Reported Event|Cohort 12: PF-04856883 25.0 mg|Participants received subcutaneous injection of PF-04856883 25.0 mg on Day 1, 8, 15 and 22.
973231|NCT00886821|E12|Reported Event|Cohort 11: PF-04856883 20.0 mg|Participants received subcutaneous injection of PF-04856883 20.0 mg on Day 1, 8, 15 and 22.
973232|NCT00886821|E11|Reported Event|Cohort 10: PF-04856883 15.0 mg|Participants received subcutaneous injection of PF-04856883 15.0 mg on Day 1, 8, 15 and 22.
973233|NCT00886821|E10|Reported Event|Cohort 1-9: Placebo|Participants received placebo matched to PF-04856883 subcutaneous injection either single dose on Day 1 or multiple dose on Day 1 and 8 respectively.
973234|NCT00886821|E9|Reported Event|Cohort 9: PF-04856883 18.0 mg|Participants received subcutaneous injection of PF-04856883 18.0 mg on Day 1 and 8.
973235|NCT00886821|E8|Reported Event|Cohort 8: PF-04856883 36.0 mg|Participants received single subcutaneous injection of PF-04856883 36.0 mg on Day 1.
973236|NCT00886821|E7|Reported Event|Cohort 7: PF-04856883 24.0 mg|Participants received single subcutaneous injection of PF-04856883 24.0 mg on Day 1.
973237|NCT00886821|E6|Reported Event|Cohort 6: PF-04856883 12.0 mg|Participants received single subcutaneous injection of PF-04856883 12.0 mg on Day 1.
973238|NCT00886821|E5|Reported Event|Cohort 5: PF-04856883 6.0 mg|Participants received single subcutaneous injection of PF-04856883 6.0 mg on Day 1.
973239|NCT00886821|E4|Reported Event|Cohort 4: PF-04856883 3.0 mg|Participants received single subcutaneous injection of PF-04856883 3.0 mg on Day 1.
973240|NCT00886821|E3|Reported Event|Cohort 3: PF-04856883 1.0 mg|Participants received single subcutaneous injection of PF-04856883 1.0 mg on Day 1.
973241|NCT00886821|E2|Reported Event|Cohort 2: PF-04856883 0.3 mg|Participants received single subcutaneous injection of PF-04856883 0.3 mg on Day 1.
973242|NCT00886821|E1|Reported Event|Cohort 1: PF-04856883 0.1 Milligram (mg)|Participants received single subcutaneous injection of PF-04856883 (CVX-096) 0.1 mg on Day 1.
973243|NCT00886795|B1|Baseline|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
973244|NCT00886795|P1|Participant Flow|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 infusions of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks. The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
973245|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks."
973246|NCT00886795|O1|Outcome|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
973288|NCT00886704|O2|Outcome|Convenience Drink Without EPA and DHA|
973289|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
973291|NCT00886704|O1|Outcome|Convenience Drink With EPA and DHA|Palatability
973292|NCT00886704|E2|Reported Event|Convenience Drink Without EPA and DHA|
973293|NCT00886704|E1|Reported Event|Convenience Drink With EPA and DHA (Omega-3 Fatty Acids)|
973247|NCT00886795|E1|Reported Event|Abatacept|"4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 weeks, and 8 weeks.~abatacept (Orencia ®): 4 doses of abatacept administered intravenously at baseline, 2 weeks, 4 week, and 8 weeks.The dose of abatacept received by each participant was based on weight. Participants received either 500mg, 750mg , or 1000mg of abatacept based on weights of >60 kg, 60-100kg, or 100 kg respectively."
973248|NCT00886769|B3|Baseline|Total|Total of all reporting groups
973249|NCT00886769|B2|Baseline|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973250|NCT00886769|B1|Baseline|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973251|NCT00886769|P2|Participant Flow|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973252|NCT00886769|P1|Participant Flow|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973253|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973254|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973255|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973256|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973257|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973258|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973259|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973260|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973261|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973262|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973263|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973264|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973265|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973266|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973267|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973268|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973269|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973270|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973271|NCT00886769|O2|Outcome|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973272|NCT00886769|O1|Outcome|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973273|NCT00886769|E2|Reported Event|Placebo|Patients received a single dose matching placebo of canakinumab on day 1.
973274|NCT00886769|E1|Reported Event|Canakinumab|Patients received a single dose of subcutaneous(sc) injection of canakinumab (4 mg/kg) on Day 1. Maximal total single dose of canakinumab allowed was 300 mg. Any patient who required a dose greater than 150 mg (patients>37.5 kg) received two sc injections.
973275|NCT00886743|B1|Baseline|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973276|NCT00886743|P1|Participant Flow|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973277|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973278|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973279|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973280|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973281|NCT00886743|O1|Outcome|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973282|NCT00886743|E1|Reported Event|Oprelvekin, 50 μg/kg|Participants received 50 μg/kg of oprelvekin once daily by subcutaneous injection.
973283|NCT00886704|B3|Baseline|Total|Total of all reporting groups
973296|NCT00886639|O1|Outcome|Oxygen Response|difference between 6-minute-walking test on oxygen and on medical air
973297|NCT00886639|E1|Reported Event|6MWT With Different Gas Mixtures|
973298|NCT00886626|B1|Baseline|All Participants|All enrolled participants
973299|NCT00886626|P2|Participant Flow|Control Then Exenatide|No medication control for 3-months then exenatide 5 mcg for 1-month uptitrated to 10 mcg for following 2-months
973300|NCT00886626|P1|Participant Flow|Exenatide Then Control|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months followed by control for 3-months
973301|NCT00886626|O2|Outcome|Control|No medication control for 3-months. Participants came from period 1 and period 2.
973302|NCT00886626|O1|Outcome|Exenatide|Exenatide 5 mcg for 1-month then up-titration to 10-mcg for remaining 2-months. Participants came from period 1 and period 2.
973303|NCT00886626|E2|Reported Event|Control|No medication control for 3-months.
973304|NCT00886626|E1|Reported Event|Exenatide|Exenatide 5 mcg for 1-month then uptitration to 10-mcg for remaining 2-months.
973305|NCT00886613|B4|Baseline|Total|Total of all reporting groups
973306|NCT00886613|B3|Baseline|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
973307|NCT00886613|B2|Baseline|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
973308|NCT00886613|B1|Baseline|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
973309|NCT00886613|P3|Participant Flow|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
973310|NCT00886613|P2|Participant Flow|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
973311|NCT00886613|P1|Participant Flow|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
973312|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
973313|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
973314|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
973315|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
973316|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
973317|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
973318|NCT00886613|O3|Outcome|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
973319|NCT00886613|O2|Outcome|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
973320|NCT00886613|O1|Outcome|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
973321|NCT00886613|O2|Outcome|Part A Participants - VZV Skin Reaction (72 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 72 hours.
973322|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (48 Hrs)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction after 48 hours.
973323|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
973324|NCT00886613|O1|Outcome|Part A Participants - VZV Skin Reaction (Baseline)|All 42 participants enrolled for part A were administered the VZV skin test and assessed for a skin reaction at baseline.
973325|NCT00886613|E3|Reported Event|Placebo|Participants randomized to receive two subcutaneous injections of 0.65 mL of placebo administered at Day 1 and Day 31.
973326|NCT00886613|E2|Reported Event|Zostavax™|Participants randomized to receive two subcutaneous injections of 0.65 mL Zostavax™ administered at Day 1 and Day 31.
973327|NCT00886613|E1|Reported Event|V212|"Participants randomized to receive two subcutaneous injections of 0.65 mL V212 (heat treated VZV Vaccine)~administered at Day 1 and Day 31."
973328|NCT00886600|B5|Baseline|Total|Total of all reporting groups
973329|NCT00886600|B4|Baseline|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973330|NCT00886600|B3|Baseline|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
973331|NCT00886600|B2|Baseline|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973332|NCT00886600|B1|Baseline|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973333|NCT00886600|P4|Participant Flow|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally twice daily (b.i.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
973334|NCT00886600|P3|Participant Flow|Losartan 100 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 100 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period:Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy).orally once daily for 2 weeks"
973397|NCT00886340|O1|Outcome|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
1025159|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
973335|NCT00886600|P2|Participant Flow|Losartan 50 mg q.d. / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan 50 mg orally once daily (q.d.) for 4 weeks~Combination Therapy Period: Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
973336|NCT00886600|P1|Participant Flow|Placebo / HCTZ 12.5 mg|"Double-blind Monotherapy: Losartan placebo orally once daily for 4 weeks~Combination Therapy Period: Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg after 4 weeks of losartan monotherapy) orally once daily for 2 weeks"
973337|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973338|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
973339|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973340|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973341|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973342|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
973343|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973344|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973345|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973346|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
973347|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973348|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973349|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973350|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
973351|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973352|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973353|NCT00886600|O4|Outcome|Losartan 50 mg b.i.d. / HCTZ 12.5 mg|Losartan 50 mg orally twice daily for 4 weeks followed by Losartan 50 mg twice daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973354|NCT00886600|O3|Outcome|Losartan 100 mg q.d. / HCTZ 12.5 mg|Losartan 100 mg orally once daily for 4 weeks followed by Losartan 100 mg once daily + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg).orally once daily for 2 weeks
973355|NCT00886600|O2|Outcome|Losartan 50 mg q.d. / HCTZ 12.5 mg|Losartan 50 mg orally once daily for 4 weeks followed by Losartan 50 mg + open-label HCTZ 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973356|NCT00886600|O1|Outcome|Placebo / HCTZ 12.5 mg|Losartan placebo orally once daily for 4 weeks followed by Losartan placebo + open-label hydrochlorothiazide (HCTZ) 12.5 mg (for patients with SiDBP ≥85 mm Hg) orally once daily for 2 weeks
973357|NCT00886587|B3|Baseline|Total|Total of all reporting groups
973358|NCT00886587|B2|Baseline|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973359|NCT00886587|B1|Baseline|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973360|NCT00886587|P2|Participant Flow|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973361|NCT00886587|P1|Participant Flow|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973362|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973363|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
1025160|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
973364|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973365|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973366|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973367|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973368|NCT00886587|O2|Outcome|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973369|NCT00886587|O1|Outcome|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973370|NCT00886587|E2|Reported Event|Atopiclair® Skin and Wound Emulsion|Atopiclair® Skin and Wound Emulsion - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973371|NCT00886587|E1|Reported Event|Investigational Device|Investigational Device - Apply 3 times daily (or as needed) on all body areas, including the affected areas of the body and face throughout duration of the study. Massage gently into skin.
973372|NCT00886483|B3|Baseline|Total|Total of all reporting groups
973373|NCT00886483|B2|Baseline|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
973374|NCT00886483|B1|Baseline|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
973375|NCT00886483|P2|Participant Flow|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
973376|NCT00886483|P1|Participant Flow|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
973377|NCT00886483|O2|Outcome|Sham Neurofeedback|Participants in the Sham group completing 40 treatments
973378|NCT00886483|O1|Outcome|Active Neurofeedback|All participants in the Active group completing 40 treatments
973379|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
973380|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
973381|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 24th treatment (n=10).
973382|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 24th treatment (n=24).
973383|NCT00886483|O2|Outcome|Sham Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Sham Neurofeedback group.
973384|NCT00886483|O1|Outcome|Active Neurofeedback|Correct guess vs. incorrect guess/don't know/decline to guess for Neurofeedback group.
973385|NCT00886483|O2|Outcome|Sham Neurofeedback|Number of participants in the Sham Neurofeedback group (n=13) that completed treatment through the 40th treatment (n=10).
973386|NCT00886483|O1|Outcome|Active Neurofeedback|Number of participants in the Neurofeedback group (n=26) that completed treatment through the 40th treatment (n=24).
973387|NCT00886483|O2|Outcome|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant's brainwave power spectrum.
973388|NCT00886483|O1|Outcome|Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
973389|NCT00886483|E2|Reported Event|Sham Neurofeedback|The sham condition will appear identical to the neurofeedback in all aspects: equipment, duration, frequency, and videogame choices. The only difference is that the interface module will be pre-programmed to give random feedback rather than contingent on the participant’s brainwave power spectrum.
973390|NCT00886483|E1|Reported Event|Active Neurofeedback|In the active neurofeedback condition, subjects will receive accurate neurofeedback either twice weekly vs. three times a week, with the same amount of total treatment over 40 sessions, varying only in frequency.
973391|NCT00886340|B3|Baseline|Total|Total of all reporting groups
973392|NCT00886340|B2|Baseline|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
973393|NCT00886340|B1|Baseline|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
973394|NCT00886340|P2|Participant Flow|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
973395|NCT00886340|P1|Participant Flow|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
973597|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973396|NCT00886340|O2|Outcome|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
1025161|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
973398|NCT00886340|E2|Reported Event|Lifestyle Counseling|Lifestyle counseling (enhanced standard care and 6 appointments with nurse practitioner)
973399|NCT00886340|E1|Reported Event|Enhanced Standard Care|Enhanced standard care (one appointment with nurse practitioner and one appointment with nutritionist)
973400|NCT00886288|B3|Baseline|Total|Total of all reporting groups
973401|NCT00886288|B2|Baseline|Patients With Albuminuria Treated With Telmisartan|baseline population
973402|NCT00886288|B1|Baseline|Patients Without Albuminuria Treated With Telmisartan|baseline population
973403|NCT00886288|P2|Participant Flow|Patients With Albuminuria Treated With Telmisartan|
973404|NCT00886288|P1|Participant Flow|Patients Without Albuminuria Treated With Telmisartan|
973405|NCT00886288|O1|Outcome|Patients With Albuminuria Treated With Telmisartan|
973406|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
973407|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
973408|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
973409|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
973410|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
973411|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
973412|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
973413|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
973414|NCT00886288|O2|Outcome|Patients With Albuminuria Treated With Telmisartan|
973415|NCT00886288|O1|Outcome|Patients Without Albuminuria Treated With Telmisartan|
973416|NCT00886288|E3|Reported Event||patients without baseline albuminuria data
973417|NCT00886288|E2|Reported Event|Patients With Albuminuria Treated With Telmisartan|
973418|NCT00886288|E1|Reported Event|Patients Without Albuminuria Treated With Telmisartan|
973419|NCT00886145|B1|Baseline|Vibration- Right Leg and No Vibration-left Leg|"The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.~At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month."
973420|NCT00886145|P1|Participant Flow|Vibration: Right Leg and No Vibration: Left Leg|"The subjects will undergo vibration intervention in the seated position, 5 sessions a week, each session lasting 20 minutes for 6 months. All footwear will be removed, but they may wear socks or be barefoot. Only the right leg will be vibrated and the left leg will serve as a control. The frequency and force of the vibrations will be approximately 35 Hz and 0.3 g.~In additional load of 50lbs will be added to both legs by using an extra wide strap equipped with bungee cords."
973421|NCT00886145|O2|Outcome|No Vibration- Left Leg|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
973422|NCT00886145|O1|Outcome|Vibration- Right Leg|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
973423|NCT00886145|E2|Reported Event|No Vibration-left Leg:|No Vibration-left leg: At each vibration training session, the left leg will serve as a control with a load of 50lbs added to the left leg using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
973424|NCT00886145|E1|Reported Event|Vibration- Right Leg:|Vibration- right leg: The subjects will undergo a mechanical vibration intervention (Juvent Vibrating plate) in the seated position, with a load of 50lbs will be added to the right leg by using an extra wide strap equipped with bungee cords, 5 sessions a week, and each session lasting 20 minutes for a total of 6 month.
973425|NCT00886119|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects.
973426|NCT00886119|P2|Participant Flow|Omafilcon A / Lotrafilcon B|Omafilcon A multifocal contact lens worn first, with Lotrafilcon B multifocal contact lens worn second. Both products worn in a daily wear basis.
973427|NCT00886119|P1|Participant Flow|Lotrafilcon B / Omafilcon A|Lotrafilcon B multifocal contact lens worn first, with Omafilcon A multifocal contact lens worn second. Both products worn in a daily wear basis.
973428|NCT00886119|O2|Outcome|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
973429|NCT00886119|O1|Outcome|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear use
973430|NCT00886119|E2|Reported Event|Omafilcon A|Hydrogel, soft, multifocal contact lens for daily wear
973431|NCT00886119|E1|Reported Event|Lotrafilcon B|Silicone hydrogel, soft, multifocal contact lens for daily wear
973432|NCT00886015|B3|Baseline|Total|Total of all reporting groups
973433|NCT00886015|B2|Baseline|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
973434|NCT00886015|B1|Baseline|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
973435|NCT00886015|P2|Participant Flow|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
973436|NCT00886015|P1|Participant Flow|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
973437|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
973438|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
973598|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973439|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
973602|NCT00885365|E2|Reported Event|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973440|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
973441|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
973442|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
973443|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
973444|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
973445|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
973446|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
973447|NCT00886015|O2|Outcome|Standard BLTR Technique|"Standard BLTR technique will be used in trichiasis surgery.~Standard BLTR Technique: bilamellar tarsal rotation procedure in trichiasis surgery"
973448|NCT00886015|O1|Outcome|TT Clamp|"The TT clamp will be used in trichiasis surgery.~TT Clamp: trichiasis surgery performed with TT clamp"
973449|NCT00886015|E2|Reported Event|TT Clamp|Eyelids operated with the TT clamp instead of standard BLTR instrumentation. The TT clamp replaces the 2 hemostats and lid plate
973450|NCT00886015|E1|Reported Event|Standard Instrumentation|Eyelids operated with standard BLTR instrumentation
973451|NCT00885846|B4|Baseline|Total|Total of all reporting groups
973452|NCT00885846|B3|Baseline|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
973453|NCT00885846|B2|Baseline|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
973454|NCT00885846|B1|Baseline|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
973455|NCT00885846|P3|Participant Flow|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
973456|NCT00885846|P2|Participant Flow|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
973457|NCT00885846|P1|Participant Flow|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
973458|NCT00885846|O3|Outcome|Non-treated Control|Participants were asked to maintain their conventional diabetes care for the duration of the study (12 weeks).
973459|NCT00885846|O2|Outcome|Progressive Resistance Training (PRT)|Participants practiced PRT at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
973460|NCT00885846|O1|Outcome|Qigong Therapy|Participants practiced Qigong at least three times per week for 30 minute sessions, including once a week with a certified instructor, for 12 weeks.
973461|NCT00885846|E3|Reported Event|Control|Wait list group; no activity at this arm. On list to start Qigong
973462|NCT00885846|E2|Reported Event|Progressive Resistance Training|Progressive resistance training: For 12 weeks, subjects in the PRT group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
973463|NCT00885846|E1|Reported Event|Qigong Therapy|Qigong therapy: For 12 weeks, subjects in Qigong therapy group are to follow a disciplined regular practice, 3 times a week for about 30 minutes, including once a week with a certified instructor to lead and check the correctness of their practice.
973464|NCT00885768|B1|Baseline|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
973465|NCT00885768|P1|Participant Flow|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
973466|NCT00885768|O1|Outcome|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
973467|NCT00885768|E1|Reported Event|Renal Artery Stenosis|the patients with coronary artery stenosis who have also renal artery stenosis
973468|NCT00885755|B4|Baseline|Total|Total of all reporting groups
973469|NCT00885755|B3|Baseline|No Group|This group included participants who died before any on study disease assessments or post-baseline biopsies. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
973470|NCT00885755|B2|Baseline|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973538|NCT00885378|B1|Baseline|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
981349|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
973542|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973471|NCT00885755|B1|Baseline|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973472|NCT00885755|P3|Participant Flow|No Group|This group included participants who died before any study disease assessments or post-baseline biopsies. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression.
973473|NCT00885755|P2|Participant Flow|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973474|NCT00885755|P1|Participant Flow|Group A:Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 milligrams per square meter (mg/m^2) or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on Body Surface Area (BSA) on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973475|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973476|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973477|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973511|NCT00885677|B1|Baseline|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
973539|NCT00885378|P2|Participant Flow|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973478|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973479|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973480|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capcetabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973481|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973482|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973483|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973484|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973512|NCT00885677|P2|Participant Flow|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
973540|NCT00885378|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973541|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973599|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973485|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973486|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973487|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973488|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973489|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973490|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973491|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973535|NCT00885482|E1|Reported Event|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
973536|NCT00885378|B3|Baseline|Total|Total of all reporting groups
973537|NCT00885378|B2|Baseline|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973596|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973492|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973493|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973494|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part I of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. In Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973495|NCT00885755|O2|Outcome|Group B: Trastuzumab+Taxane/ Capecitabine <6 Weeks|This group included participants who progressed within less than six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973496|NCT00885755|O1|Outcome|Group A: Trastuzumab+Taxane /Capecitabine (6 Weeks)|This group included participants who progressed after at least six weeks of trastuzumab/taxane treatment. In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973497|NCT00885755|E1|Reported Event|All Participants|In Part 1 of the study, participants received standard first-line therapy with trastuzumab and, at the discretion of treating clinician, either paclitaxel or docetaxel. Trastuzumab was administered according to SMPC. Paclitaxel and docetaxel were administered according to one of following regimens: docetaxel 75 mg/m^2 or 100 mg/m^2 3-weekly (if docetaxel-naïve) or docetaxel 75 mg/m^2 3-weekly (if prior adjuvant docetaxel) or docetaxel 60 mg/m^2 3-weekly (if liver dysfunction due to metastatic involvement) or paclitaxel 80 mg/m^2 weekly or 175 mg/m^2 3-weekly until first disease progression. in Part II of the study, participants received capecitabine twice-daily 1000 mg/m^2 or higher, calculated based on BSA on days 1 to 14 while continuing trastuzumab treatment per standard practice until disease progression, unmanageable toxicity or participant request for discontinuation.
973498|NCT00885742|B1|Baseline|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973499|NCT00885742|P1|Participant Flow|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973500|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973501|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973502|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973503|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973504|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973505|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973506|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973507|NCT00885742|O1|Outcome|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973508|NCT00885742|E1|Reported Event|FXIII|All subjects who received a dose of Factor XIII (FXIII) Concentrate (Human).
973509|NCT00885677|B3|Baseline|Total|Total of all reporting groups
973510|NCT00885677|B2|Baseline|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
973513|NCT00885677|P1|Participant Flow|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
973514|NCT00885677|O2|Outcome|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
973515|NCT00885677|O1|Outcome|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
973516|NCT00885677|O2|Outcome|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
973517|NCT00885677|O1|Outcome|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
973518|NCT00885677|E2|Reported Event|Control Group|Patients are CRT-D patients managed according to current standard clinical practice, based on routinely performed in-office visits.
973519|NCT00885677|E1|Reported Event|Study Group|"Patients of the study arm are CRT-D patients followed-up by means of a remote disease management system (Medtronic Carelink® Network), for which an automatic alerting system is enabled for fluid accumulation, AT/AF episodes and system integrity.~Medtronic CareLink® Network: Continuous monitoring via a disease remote management system.~Patients of the Study group will receive a remote monitor and their device will be programmed to have wireless telemetry, Care Alerts, and the ability to transmit over the Medtronic CareLink® network. Clinical and device conditions will be then monitored continuously and alarms for the physician will be generated if a set of pre-defined potentially harming conditions should occur."
973520|NCT00885638|B1|Baseline|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
973521|NCT00885638|P2|Participant Flow|Sitagliptin First, Then Placebo|First intervention 1 day, washout 14 days, second intervention 1 day
973522|NCT00885638|P1|Participant Flow|Placebo First, Then Sitagliptin|First intervention 1 day, washout 14 days, second intervention 1 day
973523|NCT00885638|O2|Outcome|Sitagliptin|Sitagliptin is given before ingestion of meal
973524|NCT00885638|O1|Outcome|Placebo|A placebo tablet is given before ingestion of meal
973525|NCT00885638|O2|Outcome|Sitagliptin|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for sitagliptin
973526|NCT00885638|O1|Outcome|Placebo|Placebo first, then sitagliptin or sitagliptin first, then placebo; this is the result for placebo
973527|NCT00885638|E1|Reported Event|All Study Participants|Placebo first, then sitagliptin or sitagliptin first, then placebo
973528|NCT00885534|B1|Baseline|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
973529|NCT00885534|P1|Participant Flow|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
973530|NCT00885534|O1|Outcome|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
973531|NCT00885534|E1|Reported Event|Cisplatin, Vinblastine, Temozolomide|"Cisplatin, Vinblastine, Temozolomide: Patients will receive CVT chemotherapy which consists of the following:~Cisplatin 25 mg/m2 given intravenously on days 2-5 Vinblastine 1.5 mg/m2 given as an intravenous push on days 2-5 Temozolomide 150 mg/m2 given orally on days 1-5. In patients who cannot receive temozolomide, dacarbazine can be used instead. Dacarbazine will be given at 800 mg/m2 IV on day 1."
973532|NCT00885482|B1|Baseline|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
973533|NCT00885482|P1|Participant Flow|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
973534|NCT00885482|O1|Outcome|Single Arm|"Treatment simplification from a standard combined antiretroviral therapy including 2 NRTIs and Atazanavir with Ritonavir to Lamivudine plus Atazanavir with Ritonavir. Treatment simplification from three-drugs- to two-drugs-based antiretroviral therapy."
981350|NCT00862082|O1|Outcome|PR104|
973543|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973544|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973545|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973546|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973547|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973548|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973549|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973550|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973551|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973552|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973553|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973554|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973555|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973556|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973557|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973558|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973559|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973560|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973561|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973562|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973563|NCT00885378|O2|Outcome|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973564|NCT00885378|O1|Outcome|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973565|NCT00885378|E2|Reported Event|Saxagliptin 2.5 mg + Metformin Immediate Release (IR)|Saxagliptin 2.5 mg tablets orally (PO) plus a flexible metformin IR dose twice daily (BID).
973566|NCT00885378|E1|Reported Event|Placebo + Metformin IR|2.5 mg placebo tablets PO BID plus flexible metformin IR dose.
973567|NCT00885365|B3|Baseline|Total|Total of all reporting groups
973568|NCT00885365|B2|Baseline|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973569|NCT00885365|B1|Baseline|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973570|NCT00885365|P2|Participant Flow|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973571|NCT00885365|P1|Participant Flow|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973572|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973573|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973574|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973575|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973576|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973577|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973578|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973579|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973580|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973581|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973582|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973583|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973584|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973585|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973586|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973587|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973588|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973589|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973590|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973591|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973592|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973593|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973594|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
973595|NCT00885365|O1|Outcome|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973600|NCT00885365|O2|Outcome|TOBI|tobramycin / TOBI administered 300mg twice a day for 4 weeks
1025162|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
973603|NCT00885365|E1|Reported Event|Bramitob|tobramycin / Bramitob administered 300mg twice a day for 4 weeks
973604|NCT00885352|B3|Baseline|Total|Total of all reporting groups
973605|NCT00885352|B2|Baseline|Placebo|Placebo to sitagliptin once daily
973606|NCT00885352|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily
973607|NCT00885352|P2|Participant Flow|Placebo|Placebo to sitagliptin once daily
973608|NCT00885352|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily
973609|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
973610|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
973611|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
973612|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
973613|NCT00885352|O2|Outcome|Placebo|Placebo to sitagliptin once daily
973614|NCT00885352|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily
973615|NCT00885352|E2|Reported Event|Placebo|Placebo to sitagliptin once daily
973616|NCT00885352|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg once daily
973617|NCT00885170|B3|Baseline|Total|Total of all reporting groups
973618|NCT00885170|B2|Baseline|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973619|NCT00885170|B1|Baseline|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973620|NCT00885170|P2|Participant Flow|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973621|NCT00885170|P1|Participant Flow|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973622|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973623|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973624|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973625|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973626|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973627|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973628|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973629|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973630|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973631|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973632|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973633|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973634|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973635|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973636|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
1025163|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
973637|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973638|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973639|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973640|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973641|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973642|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973643|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973644|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973645|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973646|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973647|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973648|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973649|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973650|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973651|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973652|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973653|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973654|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973655|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973656|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973657|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973658|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973659|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973660|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973661|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973662|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973663|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973664|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973665|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973666|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973667|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973668|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973669|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973670|NCT00885170|O2|Outcome|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973671|NCT00885170|O1|Outcome|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973672|NCT00885170|E2|Reported Event|Placebo|Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973673|NCT00885170|E1|Reported Event|Odanacatib 50 mg|Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of approximately 1200 mg.
973674|NCT00885118|B6|Baseline|Total|Total of all reporting groups
973675|NCT00885118|B5|Baseline|Empa 25 mg|Treatment with Empa 25 mg once daily
973676|NCT00885118|B4|Baseline|Empa 10 mg|Treatment with Empa 10 mg once daily
973677|NCT00885118|B3|Baseline|Empa 5 mg|Treatment with Empa 5 mg once daily
973678|NCT00885118|B2|Baseline|Empa 1 mg|Treatment with Empa 1 mg once daily
973679|NCT00885118|B1|Baseline|Placebo|Treatment with placebo once daily
973680|NCT00885118|P5|Participant Flow|Empa 25 mg|Treatment with Empa 25 mg once daily
973681|NCT00885118|P4|Participant Flow|Empa 10 mg|Treatment with Empa 10 mg once daily
973682|NCT00885118|P3|Participant Flow|Empa 5 mg|Treatment with Empa 5 mg once daily
973683|NCT00885118|P2|Participant Flow|Empa 1 mg|Treatment with Empa 1 mg once daily
973684|NCT00885118|P1|Participant Flow|Placebo|Treatment with placebo once daily
973685|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973686|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973687|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973688|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973689|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973690|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973691|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973692|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973693|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973694|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973695|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973696|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973697|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973698|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973699|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973700|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973701|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973702|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973703|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973704|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973705|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973706|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973707|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973708|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973709|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973710|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973711|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973712|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973713|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973714|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973715|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973716|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973717|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973718|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973719|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973720|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973721|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973722|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973723|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973724|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973725|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973726|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973727|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973728|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973729|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973730|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973731|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973732|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973733|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973734|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973735|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973736|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973737|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973738|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973739|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973740|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973741|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973742|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973743|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973744|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973745|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973746|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973747|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973748|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973749|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973750|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973751|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973752|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973753|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973754|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973755|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973756|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973757|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973758|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973759|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973760|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973761|NCT00885118|O4|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973762|NCT00885118|O3|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973763|NCT00885118|O2|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973764|NCT00885118|O1|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973765|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973766|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973767|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973768|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973769|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973770|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973771|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973772|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973773|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973774|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973775|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973776|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973777|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973778|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973779|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973780|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973781|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973782|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973783|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973784|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973785|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973786|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973787|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973788|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973789|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973790|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973791|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973792|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973793|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973794|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973795|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973796|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973797|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973798|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973799|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973800|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973801|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973802|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973803|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973804|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973805|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973806|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973807|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973808|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973809|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973810|NCT00885118|O5|Outcome|Empa 25 mg|Treatment with Empa 25 mg once daily
973811|NCT00885118|O4|Outcome|Empa 10 mg|Treatment with Empa 10 mg once daily
973812|NCT00885118|O3|Outcome|Empa 5 mg|Treatment with Empa 5 mg once daily
973813|NCT00885118|O2|Outcome|Empa 1 mg|Treatment with Empa 1 mg once daily
973814|NCT00885118|O1|Outcome|Placebo|Treatment with placebo once daily
973815|NCT00885118|E5|Reported Event|Empa 25 mg|Treatment with Empa 25 mg once daily
973816|NCT00885118|E4|Reported Event|Empa 10 mg|Treatment with Empa 10 mg once daily
973817|NCT00885118|E3|Reported Event|Empa 5 mg|Treatment with Empa 5 mg once daily
973818|NCT00885118|E2|Reported Event|Empa 1 mg|Treatment with Empa 1 mg once daily
973819|NCT00885118|E1|Reported Event|Placebo|Treatment with placebo once daily
973820|NCT00885105|B3|Baseline|Total|Total of all reporting groups
973821|NCT00885105|B2|Baseline|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973822|NCT00885105|B1|Baseline|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973823|NCT00885105|P2|Participant Flow|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973824|NCT00885105|P1|Participant Flow|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973825|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973826|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973827|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973828|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973829|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973830|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973831|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973832|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973833|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973834|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973835|NCT00885105|O2|Outcome|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973836|NCT00885105|O1|Outcome|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973837|NCT00885105|E2|Reported Event|Influenza Vaccine-Naive Group|Participants had never previously received influenza vaccine, they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973838|NCT00885105|E1|Reported Event|Fluzone® Vaccine-Primed Group|Participants had received 2 doses of Fluzone® vaccine at age 2 to 3 months; they received 2 doses of Fluzone® 2005-2006 pediatric formulation at age 6 to 11 months.
973839|NCT00885092|B3|Baseline|Total|Total of all reporting groups
973840|NCT00885092|B2|Baseline|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
973841|NCT00885092|B1|Baseline|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. Contact lenses worn bilaterally on a daily wear basis, with a new pair dispensed at the beginning of each period.
973842|NCT00885092|P2|Participant Flow|RepleniSH / FID 114675A|RepleniSH in Period 1; FID 114675A in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
973843|NCT00885092|P1|Participant Flow|FID 114675A / RepleniSH|FID 114675A in Period 1; RepleniSH in Period 2. Each solution was used for 7 days, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of each period and worn bilaterally on a daily wear basis.
973844|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
973845|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
973846|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
973847|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
973848|NCT00885092|O2|Outcome|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
973849|NCT00885092|O1|Outcome|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions. A new pair of silicone hydrogel contact lenses was dispensed at the start of the 7 days and worn bilaterally on a daily wear basis.
973850|NCT00885092|E2|Reported Event|RepleniSH|Commercially marketed solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
973851|NCT00885092|E1|Reported Event|FID 114675A|FID 114675A solution used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel contact lenses, per protocol-specified instructions.
973852|NCT00885079|B3|Baseline|Total|Total of all reporting groups
973853|NCT00885079|B2|Baseline|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
973854|NCT00885079|B1|Baseline|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
973855|NCT00885079|P2|Participant Flow|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
973856|NCT00885079|P1|Participant Flow|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
973857|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
973858|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
973859|NCT00885079|O2|Outcome|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
973860|NCT00885079|O1|Outcome|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
973861|NCT00885079|E2|Reported Event|Hyaluronate|"Instillation,6 times/day for 4 weeks~Hyalein Mini Ophthalmic solution : Hyalein Mini Ophthalmic solution 0.1%"
973862|NCT00885079|E1|Reported Event|Rebamipide|"Instillation,4 times/day for 4 weeks~OPC-12759 Ophthalmic suspension : OPC-12759 Ophthalmic suspension 2%"
973863|NCT00884949|B1|Baseline|BMN 110|Dose-Escalation Period:
973864|NCT00884949|P1|Participant Flow|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
973865|NCT00884949|O5|Outcome|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
973866|NCT00884949|O4|Outcome|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
973867|NCT00884949|O3|Outcome|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
973868|NCT00884949|O2|Outcome|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
973869|NCT00884949|O1|Outcome|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
973870|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
973871|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
973872|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
973873|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
973874|NCT00884949|O1|Outcome|BMN 110|"Dose-Escalation Period:~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 in 3 consecutive 12-week dosing intervals, using the following regimen:~Weeks 1-12: 0.1 mg/kg/week~Weeks 13-24: 1.0 mg/kg/week~Weeks 25-36: 2.0 mg/kg/week~Continuation Period:~Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week."
973875|NCT00884949|E5|Reported Event|Entire Study|Entire Study period includes both Dose-Escalation Period and Continuation Period.
973876|NCT00884949|E4|Reported Event|Continuation Period|Subjects who complete the 36-week Dose-Escalation Period will have the option to continue drug treatment for an additional 36 to 48 weeks. Subjects continuing on treatment after the Dose-Escalation period will receive weekly 4- to 5-hour intravenous infusions of BMN 110 at a dose of 1.0 mg/kg/week.
973877|NCT00884949|E3|Reported Event|2.0 mg/kg/Week|"Dose-Escalation Period: Weeks 25-36: 2.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 2.0 mg/kg/week"
973878|NCT00884949|E2|Reported Event|1.0 mg/kg/Week|"Dose-Escalation Period: Weeks 13-24: 1.0 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 1.0 mg/kg/week"
973879|NCT00884949|E1|Reported Event|0.1 mg/kg/Week|"Dose-Escalation Period: Weeks 1-12: 0.1 mg/kg/week~Subjects will receive a weekly 4- to 5-hour intravenous infusion of BMN 110 0.1 mg/kg/week"
973880|NCT00884910|B1|Baseline|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
973881|NCT00884910|P1|Participant Flow|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
973882|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
973883|NCT00884910|O1|Outcome|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
973884|NCT00884910|E1|Reported Event|Provox Vega 22.5|The newly developed Provox Vega voice prosthesis, with an outer diameter of 22.5 French, was placed in the tracheoesophageal puncture of laryngectomized patients. Before the study, the patients were using another voice prosthesis (Provox2). The Provox2 is the predecessor of the Provox Vega. At the start of the study the patients' Provox2 voice prosthesis was removed and replaced with the Provox Vega 22.5.
973885|NCT00884897|B3|Baseline|Total|Total of all reporting groups
973886|NCT00884897|B2|Baseline|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
973919|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
1025164|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
973887|NCT00884897|B1|Baseline|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
973888|NCT00884897|P2|Participant Flow|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
973889|NCT00884897|P1|Participant Flow|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
973890|NCT00884897|O2|Outcome|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
973891|NCT00884897|O1|Outcome|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
973892|NCT00884897|O2|Outcome|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
973893|NCT00884897|O1|Outcome|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
973894|NCT00884897|E2|Reported Event|Placebo|"We will be purchasing oxytocin placebo nasal spray through LABOSWISS located in Davos, Switzerland and distributed through PharmaWorld. LABOSWISS will manufacture the matching the placebo under GDP guidelines. The placebo will be in every way identical to the oxytocin formulation but will not contain OT.~Placebo: Placebo given as 20 IU BID"
973895|NCT00884897|E1|Reported Event|Oxytocin|"We will purchase OT from PharmaWorld, an international pharmacy located in Switzerland; the preparation of intranasal OT is manufactured by Novartis and sold under the trade name: Syntocinon. We have obtained an IND (number 78,246) for Syntocinon (intranasal oxytocin) manufactured by Novartis.~Oxytocin: Oxytocin given as 20 IU BID"
973896|NCT00884832|B3|Baseline|Total|Total of all reporting groups
973897|NCT00884832|B2|Baseline|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973898|NCT00884832|B1|Baseline|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973899|NCT00884832|P2|Participant Flow|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973900|NCT00884832|P1|Participant Flow|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973901|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973902|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973903|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973904|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973905|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973906|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973907|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973908|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973909|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973910|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973911|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973912|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973913|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973914|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973915|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973916|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973917|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973918|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973920|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973921|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973922|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973923|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973924|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973925|NCT00884832|O2|Outcome|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973926|NCT00884832|O1|Outcome|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973927|NCT00884832|E2|Reported Event|Oral Placebo|Subjects randomized to the placebo group will also take 0.1 mg of matching placebo pills orally twice a day for a total of 4 weeks.
973928|NCT00884832|E1|Reported Event|Oral Clonidine|Subjects randomized to Clonidine will take 0.1 mg of the medication orally twice a day for a total of 4 weeks.
973929|NCT00884806|B1|Baseline|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
973930|NCT00884806|P1|Participant Flow|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
973931|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
973932|NCT00884806|O1|Outcome|FID 114675A|FID 114675A used 7 days for cleaning, rinsing, conditioning, disinfecting, and storing silicone hydrogel or hydrogel contact lenses, per protocol-specified instructions.
973933|NCT00884806|E1|Reported Event|FID 114675A|Investigational multi-purpose contact lens solution
973934|NCT00884793|B1|Baseline|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
973935|NCT00884793|P1|Participant Flow|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
973936|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
973937|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
973938|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
973939|NCT00884793|O1|Outcome|Intensification Arm|5 subjects were intensified with raltegravir alone, 2 received raltegravir plus efavirenz, and 1 received raltegravir plus ritonavir/darunavir
973940|NCT00884793|E1|Reported Event|Intensification Arm|In addition to continuing the baseline ART regimen (2 NRTIs and either a PI or NNRTI), all subjects will receive raltegravir 400mg PO (by mouth) BID (twice daily). Subjects who are suitable candidates will have the option of adding a second drug, consisting of either a study NNRTI or a study PI. Subjects who are not already on an NNRTI and who are suitable candidates will have the option of adding a study NNRTI (either efavirenz or etravirine), while subjects who are not on a PI and who are suitable candidates will have the option of adding a study PI. PIs used as study drugs will include atazanavir (+/- ritonavir), fosamprenavir (+/-ritonavir), lopinavir/ritonavir, and darunavir/ritonavir.
973941|NCT00884754|B3|Baseline|Total|Total of all reporting groups
973942|NCT00884754|B2|Baseline|90º Curvature, Malleable Stylet|
973943|NCT00884754|B1|Baseline|Rigid GlideScope Specific Stylet|
973944|NCT00884754|P2|Participant Flow|90º Curvature, Malleable Stylet|
973945|NCT00884754|P1|Participant Flow|Rigid GlideScope Specific Stylet|
973946|NCT00884754|O2|Outcome|90º Curvature, Malleable Stylet|
973947|NCT00884754|O1|Outcome|Rigid GlideScope Specific Stylet|
973948|NCT00884754|E2|Reported Event|90º Curvature, Malleable Stylet|
973949|NCT00884754|E1|Reported Event|Rigid GlideScope Specific Stylet|
973950|NCT00884741|B4|Baseline|Total|Total of all reporting groups
973951|NCT00884741|B3|Baseline|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
973952|NCT00884741|B2|Baseline|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
973953|NCT00884741|B1|Baseline|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
973954|NCT00884741|P4|Participant Flow|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
973955|NCT00884741|P3|Participant Flow|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
973956|NCT00884741|P2|Participant Flow|Step 2 Registration: Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization
973957|NCT00884741|P1|Participant Flow|Step 1 Registration|No treatment. Central Pathology Tissue Screening to confirm histology and adequacy of tissue for MGMT analysis and molecular profile. Tumor tissue must be received and central review confirmation completed before STEP 2 registration can occur.
973958|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
973959|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
973960|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
973961|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
973962|NCT00884741|O2|Outcome|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
973963|NCT00884741|O1|Outcome|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
973964|NCT00884741|E3|Reported Event|Randomized Arm 2: TMZ+RT + Bevacizumab|Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
973965|NCT00884741|E2|Reported Event|Randomized Arm 1: TMZ+RT + Placebo|Temozolomide post-randomization,Radiation therapy post-randomization, placebo
973966|NCT00884741|E1|Reported Event|Pre-Randomization TMZ+RT|Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
973967|NCT00884585|B3|Baseline|Total|Total of all reporting groups
973968|NCT00884585|B2|Baseline|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
973969|NCT00884585|B1|Baseline|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
973970|NCT00884585|P2|Participant Flow|Placebo Followed by COS|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months followed by cyclosporine ophthalmic solution 0.010% up to 9 additional months; at Month 9 the dose may be adjusted to 2 times a day.
973971|NCT00884585|P1|Participant Flow|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
973972|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
973973|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
973974|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
973975|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
973976|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
973977|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
973978|NCT00884585|O2|Outcome|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
973979|NCT00884585|O1|Outcome|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
973980|NCT00884585|E2|Reported Event|Placebo|Placebo (cyclosporine vehicle) administered 4 times a day to the qualified eye(s) for 3 months.
973981|NCT00884585|E1|Reported Event|Cyclosporine Ophthalmic Solution (COS) Followed by COS|Cyclosporine ophthalmic solution 0.010% administered 4 times a day to the qualified eye(s) for up to 12 months; at Month 9 the dose may be adjusted to 2 times a day.
973982|NCT00884390|B3|Baseline|Total|Total of all reporting groups
973983|NCT00884390|B2|Baseline|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
973984|NCT00884390|B1|Baseline|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
973985|NCT00884390|P2|Participant Flow|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
973986|NCT00884390|P1|Participant Flow|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
973987|NCT00884390|O1|Outcome|All Participants With at Least One Prophylaxis Infusion|All enrolled participants with at least one prophylaxis infusion
973988|NCT00884390|O1|Outcome|All Participants With at Least One Bleed|All enrolled participants with at least one bleed.
973989|NCT00884390|O2|Outcome|Participants Following a Prophylaxis Regimen at Baseline|All enrolled participants following a prophylaxis regimen at baseline
973990|NCT00884390|O1|Outcome|Participants Following a Non-prophylaxis Regimen at Baseline|All enrolled participants following an on-demand or preventive regimen at baseline
973991|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
973992|NCT00884390|O1|Outcome|All Participants|All enrolled participants following a non-prophylaxis regimen at baseline.
973993|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
973994|NCT00884390|O1|Outcome|Participants Who Received at Least One Prophylactic Infusion|Participants who had at least one prophylaxis dose, and at least one bleed.
974600|NCT00883168|B1|Baseline|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
974433|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
973995|NCT00884390|O1|Outcome|All Participants With Bleeds|Includes any infusion with an associated bleeding episode, regardless of the reason for treatment indicated on the case report form
973996|NCT00884390|O1|Outcome|First Infusion Per Bleed|Includes the first infusion for an associated bleeding episode
973997|NCT00884390|O1|Outcome|Annualized Bleed Rate|ABR by regimen at baseline is summarized for all participants for on-demand regimen, preventive regimen and prophylaxis regimen, respectively
973998|NCT00884390|O2|Outcome|Other Switch|Participants who switched from other FVIII products other than ReFacto to ReFacto AF
973999|NCT00884390|O1|Outcome|ReFacto Switch|Participants who switched from ReFacto to ReFacto AF
974000|NCT00884390|E1|Reported Event|All Participants|The primary safety analysis was performed on all subjects who received at least 1 dose of ReFacto AF.
974001|NCT00884325|B3|Baseline|Total|Total of all reporting groups
974002|NCT00884325|B2|Baseline|Subjects Receiving Placebo|
974003|NCT00884325|B1|Baseline|Subjects Receiving Xyzal|
974004|NCT00884325|P2|Participant Flow|Subjects Receiving Placebo|one tablet taken orally at night for 28 days
974005|NCT00884325|P1|Participant Flow|Subjects Receiving Xyzal|one tablet, 5 mg, taken orally at night for 28 days
974006|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
974007|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
974008|NCT00884325|O2|Outcome|Subjects Receiving Placebo|
974009|NCT00884325|O1|Outcome|Subjects Receiving Xyzal|
974010|NCT00884325|E2|Reported Event|Subjects Receiving Placebo|
974011|NCT00884325|E1|Reported Event|Subjects Receiving Xyzal|
974012|NCT00884273|B3|Baseline|Total|Total of all reporting groups
974013|NCT00884273|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974014|NCT00884273|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974015|NCT00884273|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974016|NCT00884273|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974017|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974018|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974019|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974020|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974021|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974022|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974023|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974024|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974136|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974025|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974026|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974027|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974028|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974029|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974030|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974031|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974032|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974033|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974034|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974035|NCT00884273|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974036|NCT00884273|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974037|NCT00884273|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"Goserelin implants (3.6 mg) were inserted s.c. into the abdominal wall every 28 days. The first dose was administered on Day 0. The second and third doses of goserelin were administered on Days 28 and 56, respectively.~On Day 0, participants began once-daily per-oral (p.o.) treatment with bicalutamide (50 mg) as anti-androgen flare protection; this treatment continued for 28 days after the first dose of goserelin."
974038|NCT00884273|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
974039|NCT00884221|B3|Baseline|Total|Total of all reporting groups
974040|NCT00884221|B2|Baseline|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974041|NCT00884221|B1|Baseline|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974137|NCT00884065|E2|Reported Event|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974601|NCT00883168|P4|Participant Flow|Placebo|placebo nasal spray
974042|NCT00884221|P2|Participant Flow|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
974043|NCT00884221|P1|Participant Flow|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. Hereafter, the subjects were seen on stimulation day 6 and subsequently at least every 2 days when a transvaginal ultrasound was made to monitor response to stimulation. From stimulation day 6 and onwards, dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days. Coasting was prohibited.
974044|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974045|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974046|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974047|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974048|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974049|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974050|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974051|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974052|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974053|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974054|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974138|NCT00884065|E1|Reported Event|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974055|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974056|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974057|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974058|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974059|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974060|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974061|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974062|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974063|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974064|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974065|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974066|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974067|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974139|NCT00884039|B3|Baseline|Total|Total of all reporting groups
974140|NCT00884039|B2|Baseline|15 mg Anecortave Acetate|
974141|NCT00884039|B1|Baseline|30 mg Anecortave Acetate|
974142|NCT00884039|P2|Participant Flow|15 mg Anecortave Acetate|
974143|NCT00884039|P1|Participant Flow|30 mg Anecortave Acetate|
974068|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974069|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974070|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974071|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974072|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974073|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual patient response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and subjects could be treated with gonadotrophin for a maximum of 20 days.
974074|NCT00884221|O2|Outcome|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974075|NCT00884221|O1|Outcome|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974076|NCT00884221|E2|Reported Event|Recombinant FSH|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974077|NCT00884221|E1|Reported Event|Highly Purified Menotrophin|The gonadotrophin starting dose was 150 IU daily for the first 5 days. From stimulation day 6 and onwards, the dosing could be adjusted according to individual participant response with the purpose of achieving 8-10 oocytes at the time of oocyte retrieval. The dose adjustment could be by 75 IU per adjustment and could not be done more frequently than every 4 days. The maximum allowed gonadotrophin dose was 375 IU daily and participants could be treated with gonadotrophin for a maximum of 20 days.
974078|NCT00884117|B1|Baseline|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974079|NCT00884117|P1|Participant Flow|All Participants Infected With Influenza|Participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, otherwise healthy/non-immunocompromised adults and children greater than or equal to (≥) 1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include healthy or immunocompromised children less than or equal to (≤) 12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974080|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974144|NCT00884039|O2|Outcome|15 mg Anecortave Acetate|
974145|NCT00884039|O1|Outcome|30 mg Anecortave Acetate|
974081|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974082|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974083|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974084|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974085|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974086|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974087|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974088|NCT00884117|O1|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974089|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974090|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974091|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974092|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974093|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974094|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974095|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974096|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974097|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974098|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974099|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974100|NCT00884117|O3|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974101|NCT00884117|O2|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974102|NCT00884117|O1|Outcome|Children ≤5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children ≤5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974103|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974104|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974105|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974106|NCT00884117|O1|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974107|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974108|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974109|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974110|NCT00884117|O1|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974111|NCT00884117|O6|Outcome|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974112|NCT00884117|O5|Outcome|Adults Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 5 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974113|NCT00884117|O4|Outcome|Children Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974114|NCT00884117|O3|Outcome|Children 6 to 12 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 6 to 12 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974115|NCT00884117|O2|Outcome|Children 1 to 5 Years of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children 1 to 5 years of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974116|NCT00884117|O1|Outcome|Children <1 Year of Age Treated With Oseltamivir|Otherwise healthy/non-immunocompromised children less than (<) 1 year of age with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 6 and 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974117|NCT00884117|O1|Outcome|Otherwise Healthy Participants Infected With Influenza|Otherwise healthy/non-immunocompromised participants with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled. During Years 1 to 5 of the overall study, adults and children ≥1 year of age were considered as eligible. Following a protocol amendment, inclusion criteria for Years 6 and 7 were changed to only include children ≤12 years of age being treated with an influenza antiviral medication. Participants were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974118|NCT00884117|E2|Reported Event|Participants Not Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants not receiving oseltamivir, including no treatment or other antiviral treatment, were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974119|NCT00884117|E1|Reported Event|Participants Treated With Oseltamivir|Otherwise healthy/non-immunocompromised adults and children with a positive diagnostic test of influenza and/or displaying symptoms suggestive of influenza-like illness were enrolled during Years 1 to 7 of the overall study. Participants receiving antiviral treatment with oseltamivir (according to local practice standards) were followed for up to 10 days after informed consent for virological surveillance and assessment of clinical outcomes.
974120|NCT00884065|B3|Baseline|Total|Total of all reporting groups
974121|NCT00884065|B2|Baseline|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974122|NCT00884065|B1|Baseline|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974123|NCT00884065|P2|Participant Flow|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974124|NCT00884065|P1|Participant Flow|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974125|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974126|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974127|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974128|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974129|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974130|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974131|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974132|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974133|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974134|NCT00884065|O1|Outcome|Intervention Group (Diacutaneous Fibrolysis)|The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.
974135|NCT00884065|O2|Outcome|Control Group (Placebo)|The control group was treated with a single placebo session of Diacutaneous Fibrolysis.
974149|NCT00883779|B2|Baseline|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974150|NCT00883779|B1|Baseline|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974151|NCT00883779|P2|Participant Flow|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 milligrams per day (mg/day) from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974152|NCT00883779|P1|Participant Flow|Placebo|Participants received 1250 milligrams per squared meter (mg/m^2) of gemcitabine intravenous (IV) infusion on Day 1 and 8, carboplatin 5 times (5x) area under concentration versus time curve (AUC) or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day Cycle) until disease progression (PD), unacceptable toxicity or death in primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974153|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974154|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974155|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974156|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974194|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974157|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974158|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974159|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974160|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974161|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974162|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974163|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974164|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974195|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974430|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974165|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974166|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974167|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974168|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974169|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974170|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974171|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974172|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974196|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974431|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974173|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974174|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974175|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974176|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974177|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974178|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974179|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974180|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974197|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974432|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974181|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974182|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974183|NCT00883779|O2|Outcome|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974184|NCT00883779|O1|Outcome|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974185|NCT00883779|E2|Reported Event|Erlotinib|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral erlotinib 150 mg/day from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from erlotinib could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants were treated at the discretion of the investigators' discretion (Off-study phase).
974186|NCT00883779|E1|Reported Event|Placebo|Participants received 1250 mg/m^2 of gemcitabine IV infusion on Day 1 and 8, carboplatin 5x AUC or cisplatin 75 mg/m^2 IV infusion on Day 1 and oral placebo daily from Day 15 to 28 every 4 weeks, continued for 6 cycles (28-day cycle) until PD, unacceptable toxicity or death in the primary study treatment phase. Participants who completed 6 cycles of treatment without PD or unacceptable toxicity, or if they withdrew early because of toxicity from the platinum-doublet chemotherapy, entered the post-study treatment phase and continued same treatment until PD, unacceptable toxicity or death. Participants who withdrew due to PD or toxicity from placebo could not enter the post-study treatment phase. Upon PD (during either the primary or post-study treatment phase), participants had the option to be crossed over to open-label erlotinib 150 mg/day outside the study (Off-study phase).
974187|NCT00883753|B1|Baseline|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974188|NCT00883753|P1|Participant Flow|Tocilizumab|Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974189|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974190|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974191|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974192|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974193|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974594|NCT00883181|E2|Reported Event|NSCLC|Non-small Cell Lung Cancer
974198|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974199|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974200|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974201|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974202|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974203|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974204|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974205|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974206|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974207|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974208|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974209|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974210|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974211|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974212|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974213|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974214|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974215|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974216|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974217|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974218|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974219|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974220|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974221|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974222|NCT00883753|O1|Outcome|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974223|NCT00883753|O3|Outcome|Tocilizumab + > 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking more than one DMARD at Core study Baseline.
974224|NCT00883753|O2|Outcome|Tocilizumab + 1 DMARD|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were taking one DMARD at Core study Baseline.
974225|NCT00883753|O1|Outcome|Tocilizumab Monotherapy|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first, in a subset of patients who were not taking DMARDS at Core Baseline.
974226|NCT00883753|E1|Reported Event|Tocilizumab|Participants received tocilizumab 8 mg/kg IV, maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
974227|NCT00883740|B1|Baseline|Entire Study Population|Includes groups randomized to receive matching placebo and Pregabalin, 75 up to 225 mg, twice per day in the first intervention and Pregabalin, 75 up to 225 mg, and matching placebo twice per day in the second intervention
974228|NCT00883740|P2|Participant Flow|Pregabalin, Then Placebo|Pregabalin 75 mg up to 225 mg twice per day in intervention (treatment period 1, weeks 1-4) and matching placebo twice daily in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
974229|NCT00883740|P1|Participant Flow|Placebo, Then Pregabalin|Matching placebo twice daily in first intervention (treatment period 1, weeks 1-4) and pregabalin 75 milligrams (mg) up to 225 mg twice per day in second intervention (treatment period 2, weeks 7-10) after taper and washout period (weeks 5-6).
974230|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974231|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974232|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974233|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974234|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974235|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974236|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974237|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974238|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974239|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974240|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974241|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974242|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974243|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974244|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974245|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974246|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974247|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974248|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974249|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974250|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974251|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974252|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974253|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974595|NCT00883181|E1|Reported Event|Ovarian|Ovarian Cancer
974254|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974255|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974256|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974257|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974258|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974259|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974260|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974261|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974262|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974263|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974264|NCT00883740|O2|Outcome|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974265|NCT00883740|O1|Outcome|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974266|NCT00883740|E2|Reported Event|Pregabalin|Pregabalin administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974267|NCT00883740|E1|Reported Event|Placebo|Matching Placebo administered twice daily in either first intervention treatment period 1, weeks 1-4 or second intervention treatment period 2, weeks 7-10.
974268|NCT00883675|B1|Baseline|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
974269|NCT00883675|P1|Participant Flow|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
974270|NCT00883675|O1|Outcome|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
974271|NCT00883675|E1|Reported Event|Treatment|Docetaxel: 75 mg/m2 over 1 hour every 3 weeks for 3 doses Carboplatin Area Under the Curve (AUC) 5.5 over 0.5 to 1 hour every 3 weeks for 3 doses
974272|NCT00883558|B1|Baseline|All Randomized Participants|"Following a 1-month titration period, participants were randomly assigned to 1 of 2 study treatments (Treatment A or B) for the first of two, 3-month treatment cycles. Each participant then received the second treatment for the second cycle.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of regular human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected SC, pre-meals, doses titrated to each participant individually.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected SC, pre-meals, doses titrated to each participant individually.~Throughout the study, participants requiring basal insulin used twice daily SC injections of 100 U/mL insulin glargine or maintained their usual regimen through an insulin pump."
974273|NCT00883558|P3|Participant Flow|Insulin Lispro First, Then INSULIN-PH20 NP|"Following a 1-month dose titration period, participants were randomly assigned to Treatment B for the first 3-month treatment cycle, followed by Treatment A for the second 3-month treatment cycle.~Insulin Lispro (Treatment B): 100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~INSULIN-PH20 NP (Treatment A): 100 U/mL non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
974274|NCT00883558|P2|Participant Flow|INSULIN-PH20 NP First, Then Insulin Lispro|"Following a 1-month dose titration period, participants were randomly assigned to Treatment A for the first 3-month treatment cycle, followed by Treatment B for the second 3-month treatment cycle.~INSULIN-PH20 NP (Treatment A): 100 units per milliliter (U/mL) non-preserved (NP) formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase PH20, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Insulin Lispro (Treatment B): 100 U/mL insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
974275|NCT00883558|P1|Participant Flow|All Enrolled Participants|"Prior to randomization, all enrolled participants underwent a 1-month dose titration period.~Insulin Lispro (Titration Period): 100 units per milliliter (U/mL), injected subcutaneously before meals, with doses titrated to each individual participant's glycemic control needs, for 1 month.~Participants requiring basal insulin used twice daily, subcutaneous injections of 100 U/mL insulin glargine or maintained their usual regimen through an infusion pump."
974276|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974302|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974596|NCT00883168|B5|Baseline|Total|Total of all reporting groups
974277|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974278|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974279|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974280|NCT00883558|O2|Outcome|Insulin Lispro|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974281|NCT00883558|O1|Outcome|INSULIN-PH20 NP|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974282|NCT00883558|E2|Reported Event|Insulin Lispro Treatment Period|100 units per milliliter (U/mL) insulin lispro, injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974283|NCT00883558|E1|Reported Event|INSULIN-PH20 NP Treatment Period|100 units per milliliter (U/mL) non-preserved formulation of recombinant human insulin with 5.0 micrograms per milliliter (µg/mL) recombinant human hyaluronidase (INSULIN-PH20 NP), injected subcutaneously before meals, with doses titrated to each individual participant’s glycemic control needs, for 3 months.
974284|NCT00883493|B3|Baseline|Total|Total of all reporting groups
974285|NCT00883493|B2|Baseline|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974286|NCT00883493|B1|Baseline|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974287|NCT00883493|P2|Participant Flow|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974288|NCT00883493|P1|Participant Flow|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974289|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974290|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974291|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974292|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974293|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974294|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974295|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974296|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974297|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974298|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974299|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974300|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974301|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974597|NCT00883168|B4|Baseline|Placebo|placebo nasal spray
974303|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974304|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974305|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974306|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974307|NCT00883493|O2|Outcome|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974308|NCT00883493|O1|Outcome|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974309|NCT00883493|E2|Reported Event|Quatiapine XR + Lithium|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
974310|NCT00883493|E1|Reported Event|Quetiapine XR|Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
974311|NCT00883389|B1|Baseline|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
974312|NCT00883389|P1|Participant Flow|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
974313|NCT00883389|O1|Outcome|Med-alert Pilot Group|Participants in pilot study assigned a med-alert device of bracelet or necklace
974314|NCT00883389|E1|Reported Event|Med-alert Bracelet Pilot Group|All participants assigned to the medical alert accessory group. There is no placebo
974315|NCT00883337|B4|Baseline|Total|Total of all reporting groups
974316|NCT00883337|B3|Baseline|IFNβ1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
974317|NCT00883337|B2|Baseline|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
974318|NCT00883337|B1|Baseline|Teriflunomide 7 mg / 14 mg|"Core treatment period: Teriflunomide 7 mg once daily~Extension treatment period: Teriflunomide 14 mg once daily"
974319|NCT00883337|P3|Participant Flow|IFN-β-1a / Teriflunomide 14 mg|"Core treatment period: Interferon β-1a 3 times a week.~Extension treatment period: Teriflunomide 14 mg once daily."
974320|NCT00883337|P2|Participant Flow|Teriflunomide 14 mg/14 mg|"Core treatment period: Teriflunomide 14 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
974321|NCT00883337|P1|Participant Flow|Teriflunomide 7 mg/14 mg|"Core treatment period: Teriflunomide 7 mg once daily.~Extension treatment period: Teriflunomide 14 mg once daily."
974322|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
974323|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
974324|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
974325|NCT00883337|O3|Outcome|IFN-β-1a / 14 mg|Core treatment period: Interferon β1a 3 times a week. Extension treatment period: Teriflunomide 14 mg once daily.
974326|NCT00883337|O2|Outcome|Teriflunomide 14 mg / 14 mg|Core treatment period: Teriflunomide 14 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
974327|NCT00883337|O1|Outcome|Teriflunomide 7 mg / 14 mg|Core treatment period: Teriflunomide 7 mg once daily. Extension treatment period: Teriflunomide 14 mg once daily.
974328|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
974329|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
974330|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
974331|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
974332|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
974333|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
974334|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
974335|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
974336|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
974337|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
974338|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
974339|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
974340|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
974341|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
974342|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
974343|NCT00883337|O3|Outcome|IFN-β-1a|Interferon β-1a 3 times a week
974344|NCT00883337|O2|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily
974345|NCT00883337|O1|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily
974346|NCT00883337|E6|Reported Event|Extended Treatment: Teriflunomide 14 mg (After IFN-β-1a)|Teriflunomide 14 mg once daily in extended treatment period after Interferon β-1a 3 times a week in core treatment period (mean exposure of 1000.03 days).
974429|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974347|NCT00883337|E5|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 14 mg)|Teriflunomide 14 mg once daily in extended treatment period after 14 mg in core treatment period (mean exposure of 1015.32 days).
974348|NCT00883337|E4|Reported Event|Extended Treatment: Teriflunomide 14 mg (After 7 mg)|Teriflunomide 14 mg once daily in extended treatment period after 7 mg in the core treatment period (mean exposure of 996.76 days).
974349|NCT00883337|E3|Reported Event|Core Treatment: IFN-β-1a|Interferon β-1a 3 times a week (mean exposure of 405.18 days).
974350|NCT00883337|E2|Reported Event|Core Treatment:Teriflunomide 14 mg|Teriflunomide 14 mg once daily (mean exposure of 434.43 days).
974351|NCT00883337|E1|Reported Event|Core Treatment Period: Teriflunomide 7 mg|Teriflunomide 7 mg once daily (mean exposure of 456.62 days).
974352|NCT00883246|B1|Baseline|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974353|NCT00883246|P1|Participant Flow|Atherectomy|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974354|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
974355|NCT00883246|O1|Outcome|CLI Subgroup|Wound healing was assessed in subjects who had Rutherford Clinical Category score of 5 or 6 at the time of enrollment.
974356|NCT00883246|O1|Outcome|Claudicant Subjects|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
974357|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
974358|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
974359|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974360|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974361|NCT00883246|O2|Outcome|Claudicant Subgroup (One Year)|"All claudicant subjects (RCC 1-3) enrolled in this single-arm study were treated with directional atherectomy and walking distance measured at the one year follow-up visit.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974362|NCT00883246|O1|Outcome|Claudicant Subgroup (Baseline)|"All claudicant subjects enrolled in this single-arm study were treated with directional atherectomy and had walking distance measured prior to treatment.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974363|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974364|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974365|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974366|NCT00883246|O1|Outcome|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974367|NCT00883246|O1|Outcome|CLI Subgroup|Subjects who had CLI (RCC 4 – 6) at time of enrollment
974368|NCT00883246|O1|Outcome|Claudicant Subgroup|Subjects who had claudication (RCC of 1 – 3) at time of enrollment.
974369|NCT00883246|E1|Reported Event|All Patients|"All patients enrolled in this single-arm study were treated with directional atherectomy.~SilverHawk Peripheral Plaque Excision System: Removal of atherosclerotic plaque from artery walls."
974370|NCT00883233|B5|Baseline|Total|Total of all reporting groups
974371|NCT00883233|B4|Baseline|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
974372|NCT00883233|B3|Baseline|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
974373|NCT00883233|B2|Baseline|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
974374|NCT00883233|B1|Baseline|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
974375|NCT00883233|P4|Participant Flow|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
974376|NCT00883233|P3|Participant Flow|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
974377|NCT00883233|P2|Participant Flow|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
974378|NCT00883233|P1|Participant Flow|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
974379|NCT00883233|O4|Outcome|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
974380|NCT00883233|O3|Outcome|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
974381|NCT00883233|O2|Outcome|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
974598|NCT00883168|B3|Baseline|Fluticasone Propionate|fluticasone propionate nasal spray
974382|NCT00883233|O1|Outcome|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
974383|NCT00883233|E4|Reported Event|Adapalene-BPO Gel StD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week
974384|NCT00883233|E3|Reported Event|Adapalene-BPO Gel Cetaphil|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks
974385|NCT00883233|E2|Reported Event|Adapalene-BPO Gel EoD|Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks
974386|NCT00883233|E1|Reported Event|Adapalene-BPO Gel 3h|Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks
974387|NCT00883181|B1|Baseline|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974388|NCT00883181|P1|Participant Flow|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974389|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974390|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974391|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974392|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974393|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974394|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974395|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974396|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974397|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974398|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974399|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974400|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974401|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974402|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974403|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974404|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974405|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974406|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974407|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974408|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974409|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974410|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974411|NCT00883181|O2|Outcome|No ESA Use|Participants who did not receive treatment with a erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
974412|NCT00883181|O1|Outcome|Any ESA Use|Participants who received treatment with any erythropoiesis-stimulating agent (ESA) during cycles 1 to 8.
974413|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974414|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974415|NCT00883181|O1|Outcome|Full Analysis Set|Participants diagnosed with breast, ovarian, or lung cancer and receiving myelotoxic chemotherapy.
974416|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974417|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974418|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974419|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974420|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974421|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974422|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974423|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974424|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974425|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974426|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974427|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974428|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974599|NCT00883168|B2|Baseline|Azelastine Hcl|azelastine HCl nasal spray
974434|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974435|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974436|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974437|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974438|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974439|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974440|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974441|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974442|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974443|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974444|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974445|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974446|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974447|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974448|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974449|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974450|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974451|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974452|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974453|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974454|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974455|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974456|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974457|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974458|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974459|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974460|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974461|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974462|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974463|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974464|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974465|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974466|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974467|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974468|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974469|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974470|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974471|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974472|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974473|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974474|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974475|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974476|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974477|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974478|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974479|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974480|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974481|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974482|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974483|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974484|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974485|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974846|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
974486|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974487|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974488|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974489|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974490|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974491|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974492|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974493|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974494|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974495|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974496|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974497|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974498|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974499|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974500|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974501|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974502|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974503|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974504|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974505|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974506|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974507|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974508|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974509|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974510|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974511|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974512|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974513|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974514|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974515|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974516|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974517|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974518|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974519|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974520|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974521|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974522|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974523|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974524|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974525|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974526|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974527|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974528|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974529|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974530|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974531|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974532|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974533|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974534|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974535|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974536|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974537|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974538|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974847|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
974539|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974540|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974541|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974542|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974543|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974544|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974545|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974546|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974547|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974548|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974549|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974550|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974551|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974552|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974553|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974554|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974555|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974556|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974557|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974558|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974559|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974560|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974561|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974562|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974563|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974564|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974565|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974566|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974567|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974568|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974569|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974570|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974571|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974572|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974573|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974574|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974575|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974576|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974577|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974578|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974579|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974580|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974581|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974582|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974583|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974584|NCT00883181|O6|Outcome|Breast Total|Participants diagnosed with breast cancer (any stage) and receiving chemotherapy.
974585|NCT00883181|O5|Outcome|Breast Metastatic|Participants diagnosed with metastatic breast cancer and receiving chemotherapy.
974586|NCT00883181|O4|Outcome|Breast Stage I-III|Participants diagnosed with Stage I-III breast cancer and receiving chemotherapy.
974587|NCT00883181|O3|Outcome|SCLC|Participants diagnosed with small cell lung cancer (SCLC) and receiving chemotherapy.
974588|NCT00883181|O2|Outcome|NSCLC|Participants diagnosed with non-small cell lung cancer (NSCLC) and receiving chemotherapy.
974589|NCT00883181|O1|Outcome|Ovarian|Participants diagnosed with ovarian cancer and receiving chemotherapy.
974590|NCT00883181|E6|Reported Event|Breast Total|All Breast Cancer
974591|NCT00883181|E5|Reported Event|Breast Metastatic|Breast Cancer, Metastatic
974592|NCT00883181|E4|Reported Event|Breast Stage I-III|Breast Cancer, Stages I-III
974593|NCT00883181|E3|Reported Event|SCLC|Small Cell Lung Cancer
974602|NCT00883168|P3|Participant Flow|Fluticasone Propionate|fluticasone propionate nasal spray
974603|NCT00883168|P2|Participant Flow|Azelastine Hcl|azelastine HCl nasal spray
974604|NCT00883168|P1|Participant Flow|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
974605|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
974606|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
974607|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
974608|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
974609|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
974610|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
974611|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
974612|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
974613|NCT00883168|O4|Outcome|Placebo|placebo nasal spray
974614|NCT00883168|O3|Outcome|Fluticasone Propionate|fluticasone propionate nasal spray
974615|NCT00883168|O2|Outcome|Azelastine Hcl|azelastine HCl nasal spray
974616|NCT00883168|O1|Outcome|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
974617|NCT00883168|E4|Reported Event|Placebo|placebo nasal spray
974618|NCT00883168|E3|Reported Event|Fluticasone Propionate|fluticasone propionate nasal spray
974619|NCT00883168|E2|Reported Event|Azelastine Hcl|azelastine HCl nasal spray
974620|NCT00883168|E1|Reported Event|MP29-02|azelastine HCl 548mcg / fluticasone propionate 200mcg
974621|NCT00883129|B3|Baseline|Total|Total of all reporting groups
974622|NCT00883129|B2|Baseline|Cyclophosphamide Arm|"Participants will receive oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974623|NCT00883129|B1|Baseline|Mycophenolate Arm|"Participants will receive oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974624|NCT00883129|P2|Participant Flow|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974625|NCT00883129|P1|Participant Flow|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974626|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974627|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974628|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974629|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974630|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974631|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974632|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974633|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974634|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974635|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974636|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974848|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
977029|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
974637|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974638|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974639|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974640|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974641|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974642|NCT00883129|O2|Outcome|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974643|NCT00883129|O1|Outcome|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974644|NCT00883129|E2|Reported Event|Cyclophosphamide Arm|"Participants treated with oral cyclophosphamide for 1 year, followed by placebo for 1 year.~Cyclophosphamide: 12 months of oral cyclophosphamide, up to a maximal dose of 2 mg/kg daily as tolerated~Placebo: 12 months of placebo will be delivered to participants in the Cyclophosphamide arm during the second year in order to maintain the blind with the Mycophenolate arm, which receives drug for the entire 2 years."
974645|NCT00883129|E1|Reported Event|Mycophenolate Arm|"Participants treated with oral mycophenolate mofetil for 2 years.~Mycophenolate mofetil: 24 months of oral mycophenolate mofetil, up to a maximal dose of 1.5 grams twice daily as tolerated"
974646|NCT00883116|B3|Baseline|Total|Total of all reporting groups
974647|NCT00883116|B2|Baseline|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
974648|NCT00883116|B1|Baseline|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
974649|NCT00883116|P2|Participant Flow|Control Chemotherapy|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
974650|NCT00883116|P1|Participant Flow|Ixabepilone, 40 mg/m^2, IV|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
974651|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
974652|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
974653|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
974654|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
974655|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received either paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2 given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
974656|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
974657|NCT00883116|O2|Outcome|Control With Chemotherapy (Paclitaxel or Doxorubicin)|Participants received paclitaxel, 175 mg/m^2, given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity or doxorubicin, 60 mg/m^2, given IV per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
974658|NCT00883116|O1|Outcome|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given IV over 3 hours every 21 days until unacceptable toxicity or disease progression
974849|NCT00882687|O4|Outcome|Placebo|
974850|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
974659|NCT00883116|E3|Reported Event|Control With Chemotherapy (Paclitaxel, 175 mg/m^2, IV)|Participants received paclitaxel, 175 mg/m^2 given IV over 3 hours, or per institutional guidelines but not exceeding 3 hours, every 21 days until disease progression or unacceptable toxicity.
974660|NCT00883116|E2|Reported Event|Control With Chemotherapy (Doxorubicin, 60 mg/m^2, IV)|Participants received doxorubicin, 60 mg/m^2 given intravenously (IV) per institutional guidelines every 21 days, depending on the prior therapy received, until disease progression, unacceptable toxicity, or cumulative dose of 500 mg/m^2.
974661|NCT00883116|E1|Reported Event|Ixabepilone, 40 mg/m^2, Intravenously (IV)|Participants received ixabepilone, 40 mg/m^2, given intravenously (IV) over 3 hours every 21 days until unacceptable toxicity or disease progression
974662|NCT00883103|B3|Baseline|Total|Total of all reporting groups
974663|NCT00883103|B2|Baseline|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
974664|NCT00883103|B1|Baseline|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
974665|NCT00883103|P2|Participant Flow|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
974666|NCT00883103|P1|Participant Flow|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
974667|NCT00883103|O2|Outcome|Aqueous Gel|Aqueous gel was applied to the Q-tip and the catheter before insertion.
974668|NCT00883103|O1|Outcome|Lidocaine|Lidocaine gel was applied to the Q-tip and the catheter before insertion.
974669|NCT00883103|E2|Reported Event|Placebo|Plain aqueous gel as placebo will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
974670|NCT00883103|E1|Reported Event|Lidocaine Gel|2% Lidocaine jelly will be applied onto the catheter and then the cotton swab during evaluation of postvoid residual and the Q-tip test.
974671|NCT00883090|B1|Baseline|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974672|NCT00883090|P1|Participant Flow|FXIII|All subjects treated with Factor XIII Concentrate (Human) (FXIII)
974673|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974674|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974675|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974676|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974677|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974678|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974679|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974680|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974681|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974682|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974683|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974684|NCT00883090|O1|Outcome|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974685|NCT00883090|E1|Reported Event|FXIII|All subjects treated with Factor FXIII Concentrate (Human) (FXIII)
974686|NCT00882921|B1|Baseline|Elaprase® (0.5 mg/kg)|
974687|NCT00882921|P1|Participant Flow|Elaprase® (0.5 mg/kg)|
974688|NCT00882921|O1|Outcome|Elaprase|"Idursulfase 0.5 mg/kg Weekly~Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS."
974689|NCT00882921|O1|Outcome|Idursulfase (Elaprase) 0.5 mg/kg Weekly|Idursulfase: Patients will receive idursulfase as prescribed by their physician following locally approved prescribing information. Patients will not be provided idursulfase by Shire or the HOS.
974690|NCT00882921|E1|Reported Event|Elaprase® (0.5 mg/kg)|
974691|NCT00882908|B6|Baseline|Total|Total of all reporting groups
974692|NCT00882908|B5|Baseline|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974693|NCT00882908|B4|Baseline|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974694|NCT00882908|B3|Baseline|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974695|NCT00882908|B2|Baseline|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974696|NCT00882908|B1|Baseline|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974697|NCT00882908|P5|Participant Flow|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974698|NCT00882908|P4|Participant Flow|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974851|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
974852|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
974853|NCT00882687|O4|Outcome|Placebo|
974699|NCT00882908|P3|Participant Flow|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974700|NCT00882908|P2|Participant Flow|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974701|NCT00882908|P1|Participant Flow|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974702|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974703|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974704|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974705|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974706|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974707|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974708|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974709|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974710|NCT00882908|O5|Outcome|All TMC435 Treatment Groups|Participants in all 4 TMC435 treatment groups combined.
974711|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974712|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974713|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974714|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974715|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974716|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974717|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974718|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974719|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974720|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974721|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974722|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974723|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974724|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974725|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974726|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974727|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974728|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974729|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974730|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974731|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974732|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974733|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974734|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974735|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974736|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974737|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974738|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974739|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974740|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974741|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974742|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974854|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
974855|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
974856|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
974743|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974744|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974745|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974746|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974747|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974748|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974749|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974750|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974751|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974752|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974753|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974754|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974755|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974756|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974757|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974758|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974759|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974760|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974761|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974762|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974763|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974764|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974765|NCT00882908|O5|Outcome|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974766|NCT00882908|O4|Outcome|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974767|NCT00882908|O3|Outcome|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974768|NCT00882908|O2|Outcome|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974769|NCT00882908|O1|Outcome|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974770|NCT00882908|E5|Reported Event|Placebo 24 Wks + PR48|Participants received Placebo once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks followed by PR until Week 48.
974771|NCT00882908|E4|Reported Event|TMC435 150 mg 24 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) and ribavirin (R) for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974772|NCT00882908|E3|Reported Event|TMC435 150 mg 12 Wks + PR 24/48|Participants received TMC435 150 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed Placebo and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974773|NCT00882908|E2|Reported Event|TMC435 75 mg 24 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974774|NCT00882908|E1|Reported Event|TMC435 75 mg 12 Wks + PR 24/48|Participants received TMC435 75 mg once daily with PegIFNα-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo once daily and PR for 12 weeks. Treatment with PR was stopped at Week 24 for participants who met response-guided treatment (RGT) criteria. All other participants continued PR until Week 48.
974775|NCT00882778|B1|Baseline|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974776|NCT00882778|P1|Participant Flow|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974777|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974778|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974779|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974780|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974781|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974782|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974783|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974857|NCT00882687|O4|Outcome|Placebo|
974858|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
974859|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
974784|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974785|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974786|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974787|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974788|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974789|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974790|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974791|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974792|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974793|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974794|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974795|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974796|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974797|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974798|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974799|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974860|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
974861|NCT00882687|E4|Reported Event|Placebo|
974800|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974801|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974802|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974803|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974804|NCT00882778|O1|Outcome|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974805|NCT00882778|E1|Reported Event|Activated Recombinant Human Factor VII|Male patients diagnosed with haemophilia A or B with inhibitors, who were prescribed activated recombinant human factor VII (rFVIIa) for at least 30 days. All direction for rFVIIa medication usage was at the sole discretion of the physician in accordance within their usual practice. Data was collected for approximately 6 months of pre-prophylaxis, while the prophylaxis period had no limits.
974806|NCT00882713|B1|Baseline|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974807|NCT00882713|P1|Participant Flow|C.E.R.A.|Eligible participants were administered continuous erythropoietin receptor activator (C.E.R.A.) intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974808|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974809|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974810|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974811|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974812|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974813|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974814|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974862|NCT00882687|E3|Reported Event|Lifitegrast 5.0%|
974863|NCT00882687|E2|Reported Event|Lifitegrast 1.0%|
974864|NCT00882687|E1|Reported Event|Lifitegrast 0.1%|
974865|NCT00882661|B4|Baseline|Total|Total of all reporting groups
974815|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974816|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974817|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974818|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974819|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974820|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974821|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974822|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974823|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974824|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974825|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 mcg) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 g/dL of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974826|NCT00882713|O1|Outcome|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974827|NCT00882713|E1|Reported Event|C.E.R.A.|Eligible participants were administered C.E.R.A. intravenously (IV) every 4 weeks for 44 weeks. The starting dose of C.E.R.A. (120, 200, or 360 micrograms [mcg]) was based on the dose of epoetin alfa or beta administered in the week preceding the switch to C.E.R.A. Subsequent doses were adjusted to maintain the individual participant's hemoglobin (Hb) value within a range of +/- 1.0 grams per deciliter (g/dL) of the reference Hb concentration and between 10.50 and 12.50 g/dL.
974828|NCT00882687|B5|Baseline|Total|Total of all reporting groups
974829|NCT00882687|B4|Baseline|Placebo|
974830|NCT00882687|B3|Baseline|Lifitegrast 5.0%|
974831|NCT00882687|B2|Baseline|Lifitegrast 1.0%|
974832|NCT00882687|B1|Baseline|Lifitegrast 0.1%|
974833|NCT00882687|P4|Participant Flow|Placebo|
974834|NCT00882687|P3|Participant Flow|Lifitegrast 5.0%|
974835|NCT00882687|P2|Participant Flow|Lifitegrast 1.0%|
974836|NCT00882687|P1|Participant Flow|Lifitegrast 0.1%|
974837|NCT00882687|O4|Outcome|Placebo|
974838|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
974839|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
974840|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
974841|NCT00882687|O4|Outcome|Placebo|
974842|NCT00882687|O3|Outcome|Lifitegrast 5.0%|
974843|NCT00882687|O2|Outcome|Lifitegrast 1.0%|
974844|NCT00882687|O1|Outcome|Lifitegrast 0.1%|
974845|NCT00882687|O4|Outcome|Placebo|
974866|NCT00882661|B3|Baseline|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
974867|NCT00882661|B2|Baseline|ASSURE Cervical Plate and Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974868|NCT00882661|B1|Baseline|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974869|NCT00882661|P2|Participant Flow|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974870|NCT00882661|P1|Participant Flow|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974871|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
974872|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974873|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974874|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
974875|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974876|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974877|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
974878|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974879|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974880|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
974881|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974882|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974883|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc.
974884|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974885|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974886|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
974887|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974888|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974889|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
974890|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974891|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974892|NCT00882661|O3|Outcome|Non-Randomized SECURE-C Cervical Artificial Disc|The first five subjects enrolled at each center were non-randomized subjects receiving the SECURE-C Cervical Artificial Disc
974893|NCT00882661|O2|Outcome|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974894|NCT00882661|O1|Outcome|Randomized SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974895|NCT00882661|E2|Reported Event|ASSURE Cervical Plate and an Allograft Interbody Spacer|Treatment of symptomatic cervical disc disease utilizing an instrumented anterior discectomy and interbody fusion
974896|NCT00882661|E1|Reported Event|SECURE-C Cervical Artificial Disc|Treatment of symptomatic cervical disc disease with the SECURE-C Cervical Artificial Disc
974897|NCT00882583|B3|Baseline|Total|Total of all reporting groups
974898|NCT00882583|B2|Baseline|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
974920|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
974921|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
981351|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
974899|NCT00882583|B1|Baseline|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
974900|NCT00882583|P2|Participant Flow|Cohort B T3N0-1,T1-4N2-3M0, T4N0-1M0 SCCHN|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma (SCC) of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
974901|NCT00882583|P1|Participant Flow|Cohort A T2N0, T1-2N1 SCCHN|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
974902|NCT00882583|O2|Outcome|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
974903|NCT00882583|O1|Outcome|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
974904|NCT00882583|E2|Reported Event|Cohort B|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib, in combination with q 3 week cisplatin, weekly cetuximab and RT.~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Cisplatin: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days~Radiation Therapy: Standard Radiation Therapy."
974905|NCT00882583|E1|Reported Event|Cohort A|"In both Cohort A and B, there will be an initial “run-in period” of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib from day 8-14.~Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib in combination with cetuximab and radiation therapy (RT).~Cetuximab: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8~Dasatinib: Oral Dasatinib Days 8 through 64.~Radiation Therapy: Standard Radiation Therapy."
974906|NCT00882557|B3|Baseline|Total|Total of all reporting groups
974907|NCT00882557|B2|Baseline|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
974908|NCT00882557|B1|Baseline|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
974909|NCT00882557|P2|Participant Flow|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
974910|NCT00882557|P1|Participant Flow|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
974911|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
974912|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
974913|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
974914|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
974915|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
974916|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
974917|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
974918|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
974919|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
974922|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
974923|NCT00882557|O2|Outcome|9 mg/kg During Hemodialysis (Regimen A)|Daptomycin (9 mg/kg IV) during the last 30 minutes of hemodialysis using high-flux membrane
974924|NCT00882557|O1|Outcome|6 mg/kg After Hemodialysis (Regimen B)|Daptomycin (6 mg/kg IV) after hemodialysis using high-flux membranes
974925|NCT00882557|E2|Reported Event|Sequence AB|All subjects received 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A) and 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B).
974926|NCT00882557|E1|Reported Event|Sequence BA|All subjects received 1 dose of daptomycin 6 mg/kg after hemodialysis (Regimen B) and 1 dose of daptomycin 9 mg/kg during the last 30 minutes of hemodialysis (Regimen A).
974927|NCT00882518|B3|Baseline|Total|Total of all reporting groups
974928|NCT00882518|B2|Baseline|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
974929|NCT00882518|B1|Baseline|Seroquel_XR|Quetiapine fumarate XR was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion. Full analysis set (FAS) population used for baseline characteristics
974930|NCT00882518|P2|Participant Flow|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
974931|NCT00882518|P1|Participant Flow|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
974932|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974933|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974934|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974935|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974936|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974937|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974938|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974939|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974940|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974941|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974942|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974943|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974944|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974945|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974946|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974947|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974948|NCT00882518|O2|Outcome|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator's discretion.
974949|NCT00882518|O1|Outcome|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator's discretion.
974950|NCT00882518|E2|Reported Event|Chlorpromazine|Chlorpromazine was administered orally, twice daily. The initial dose was 50 mg to 100 mg. This dose was adjusted on Day 2 from 100 to 200 mg, on Day 3 from 150 to 300 mg, and Day 4 from 200 to 400 mg. From Day 5, the dose of chlorpromazine could be adjusted at 300 mg/day, 400 mg/day, 500 mg/day, or 600 mg/day at the investigator’s discretion.
974951|NCT00882518|E1|Reported Event|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR)|Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) was administered orally, once daily in the evening. The initial dose was 300 mg. This dose was adjusted on Day 2 to 600 mg, from Day 3 to Day 42, the dose of Quetiapine fumarate XR could be adjusted at 400 mg/day, 600 mg/day, or 800 mg/day at the investigator’s discretion.
974952|NCT00882440|B8|Baseline|Total|Total of all reporting groups
974953|NCT00882440|B7|Baseline|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
974954|NCT00882440|B6|Baseline|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
974955|NCT00882440|B5|Baseline|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
974956|NCT00882440|B4|Baseline|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
974957|NCT00882440|B3|Baseline|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
974958|NCT00882440|B2|Baseline|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
974959|NCT00882440|B1|Baseline|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
974960|NCT00882440|P7|Participant Flow|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
974961|NCT00882440|P6|Participant Flow|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
974962|NCT00882440|P5|Participant Flow|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
974963|NCT00882440|P4|Participant Flow|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
974964|NCT00882440|P3|Participant Flow|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
974965|NCT00882440|P2|Participant Flow|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
974966|NCT00882440|P1|Participant Flow|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
974967|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
974968|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
974969|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
974970|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
974971|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
974972|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
974973|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
974974|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
974975|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
974976|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
974977|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
974978|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
974979|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
974980|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
974981|NCT00882440|O7|Outcome|Enalapril 20|Enalapril 20 mg orally once daily for 8 weeks
974982|NCT00882440|O6|Outcome|Losartan 150 mg|Losartan 150 mg orally once daily for 8 weeks
974983|NCT00882440|O5|Outcome|Losartan 100 mg|Losartan 100 mg orally once daily for 8 weeks
974984|NCT00882440|O4|Outcome|Losartan 50 mg|Losartan 50 mg orally once daily for 8 weeks
974985|NCT00882440|O3|Outcome|Losartan 25 mg|Losartan 25 mg orally once daily for 8 weeks
974986|NCT00882440|O2|Outcome|Losartan 10 mg|Losartan 10 mg orally once daily for 8 weeks
974987|NCT00882440|O1|Outcome|Placebo|Losartan and Enalapril placebo orally once daily for 8 weeks
974988|NCT00882362|B3|Baseline|Total|Total of all reporting groups
974989|NCT00882362|B2|Baseline|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
974990|NCT00882362|B1|Baseline|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
974991|NCT00882362|P2|Participant Flow|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
974992|NCT00882362|P1|Participant Flow|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
974993|NCT00882362|O2|Outcome|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
974994|NCT00882362|O1|Outcome|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
974995|NCT00882362|E2|Reported Event|Newly Entering Subjects|Newly entering elderly patients with major depressive disorder, aged 65 and above
974996|NCT00882362|E1|Reported Event|Continuing Subjects|Subjects receiving the study drug for at least 4 weeks during the placebo-controlled double-blind treatment period of the 031-08-001 study
974997|NCT00882310|B1|Baseline|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
974998|NCT00882310|P1|Participant Flow|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
974999|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
975000|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
975001|NCT00882310|O1|Outcome|Gemcitabine, Docetaxel, Capecitabine GTX|GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.
975002|NCT00882310|E1|Reported Event|Gemcitabine, Docetaxel, Capecitabine GTX|"GTX - A two week regimen of Gemcitabine at 600 mg/m2 on days 4 and 1, infused over 60 minutes, Docetaxel at 30 mg/m2 on days 4 and 11, infused over 60 minutes and Capecitabine at 1000 mg/m2 (capped at 1000 mg BID days 1-14) followed by one week off for a total of a 21 day cycle. This is repeated for a total of 6 months.~AE data was collected on 26 subjects (out of 37 subjects, 10 were screen failures and 1 was not treated)."
975003|NCT00882206|B1|Baseline|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
975004|NCT00882206|P1|Participant Flow|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
975005|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
975006|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
975034|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975035|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975007|NCT00882206|O1|Outcome|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12,"
975008|NCT00882206|O1|Outcome|Decitabine / Vorinostat|This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.
975009|NCT00882206|E1|Reported Event|Decitabine / Vorinostat|"This is a therapeutic trial investigating the combination of decitabine 15 mg/m2 and vorinostat 230 mg/m2 (maximum daily dose not to exceed 400 mg) in relapsed/refractory ALL/LL patients prior to induction chemotherapy.~cytarabine: At baseline when peripheral blood draw and bone marrow aspirate performed.~*Intrathecal Cytarabine administered dependent upon age - ranging from 30 mg to 70 mg.~decitabine: Days 1-4, 15 mg/m^2 intravenously (IV) over 1 hour~doxorubicin hydrochloride: Day 5, 60 mg/m^2 intravenously (IV) over 15 minutes~imatinib mesylate: 340 mg/m2 by mouth every day (rounded to the nearest 100 mg) for age <18 years and 400 mg orally every day for >18 years on Days 5-33.~methotrexate: **Intrathecal Methotrexate administered dependent upon age - ranging from 8 mg to 15 mg.~pegaspargase: 2,500 IU/m2 IM or IV q week (days 6, 12, 19, 26)~prednisone: 40mg/m2/day divided BID (days 5 – 33)~vincristine sulfate: 1.5mg/m2 (max 2 mg) iv push q week (days 5, 12)"
975010|NCT00882102|B1|Baseline|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
975011|NCT00882102|P1|Participant Flow|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
975012|NCT00882102|O1|Outcome|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m^2 by vein over 1-1/2 hours daily for 5 days. Gemtuzumab ozogamicin 3 mg/m^2 by vein on day 5.
975013|NCT00882102|E1|Reported Event|Decitabine + Gemtuzumab Ozogamicin|Decitabine 20 mg/m2 by vein over 1-1/2 hours daily x 5. Gemtuzumab ozogamicin 3 mg/m2 by vein on day 5.
975014|NCT00881959|B3|Baseline|Total|Total of all reporting groups
975015|NCT00881959|B2|Baseline|Group 2: Alloderm|"Control group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
975016|NCT00881959|B1|Baseline|Group 1: Puros Dermis|"Experimental treatment group of subjects who each have a single non-adjacent Miller's Class I or II gingival recession defect, greater than or equal to 2 mm, located on the buccal aspect of the maxillary incisor, canine, or premolar.~Puros® Dermis versus Alloderm®: Puros Dermis and Alloderm (both Allograft Tissue Matrix)"
975017|NCT00881959|P2|Participant Flow|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
975018|NCT00881959|P1|Participant Flow|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
975019|NCT00881959|O2|Outcome|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
975020|NCT00881959|O1|Outcome|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
975021|NCT00881959|E2|Reported Event|Arm 2: Alloderm|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Alloderm.
975022|NCT00881959|E1|Reported Event|Arm 1: Puros Dermis|Subjects with a single non-adjacent Miller Class I or II gingival recession treated with Puros Dermis.
975023|NCT00881894|B3|Baseline|Total|Total of all reporting groups
975024|NCT00881894|B2|Baseline|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
975025|NCT00881894|B1|Baseline|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
975026|NCT00881894|P2|Participant Flow|Sequence B-A (Reference: PR1.0 - Test: PR2.1.1)|Two single applications of rotigotine patches from two different manufacturing processes in the order B-A separated by a washout phase of at least 5 days
975027|NCT00881894|P1|Participant Flow|Sequence A-B (Test: PR2.1.1 - Reference: PR1.0)|Two single applications of rotigotine patches from two different manufacturing processes in the order A-B separated by a washout phase of at least 5 days
975028|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975029|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975030|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975031|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975032|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975033|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975237|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975036|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975037|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975038|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975039|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975040|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975041|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975042|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975043|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975044|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975045|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975046|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975047|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975048|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975049|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975050|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975051|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975052|NCT00881894|O2|Outcome|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975053|NCT00881894|O1|Outcome|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975054|NCT00881894|E2|Reported Event|Treatment B (Reference: PR1.0)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from originally approved manufacturing process (Reference; drug product PR1.0); single application of 1 patch for 24 hours
975055|NCT00881894|E1|Reported Event|Treatment A (Test: PR2.1.1)|Rotigotine transdermal patch (4.5 mg/ 10 cm^2) from modified manufacturing process (Test; drug product PR2.1.1); single application of 1 patch for 24 hours
975056|NCT00881868|B3|Baseline|Total|Total of all reporting groups
975057|NCT00881868|B2|Baseline|Vehicle Spray|
975058|NCT00881868|B1|Baseline|Clobex Spray|
975059|NCT00881868|P2|Participant Flow|Vehicle Spray|
975060|NCT00881868|P1|Participant Flow|Clobex Spray|
975061|NCT00881868|O2|Outcome|Vehicle Spray|
975062|NCT00881868|O1|Outcome|Clobex Spray|
975063|NCT00881868|O2|Outcome|Vehicle Spray|
975064|NCT00881868|O1|Outcome|Clobex Spray|
975065|NCT00881868|O2|Outcome|Vehicle Spray|
975066|NCT00881868|O1|Outcome|Clobex Spray|
975067|NCT00881868|O2|Outcome|Vehicle Spray|
975068|NCT00881868|O1|Outcome|Clobex Spray|
975069|NCT00881868|E2|Reported Event|Vehicle Spray|
975070|NCT00881868|E1|Reported Event|Clobex Spray|
975071|NCT00881712|B4|Baseline|Total|Total of all reporting groups
975072|NCT00881712|B3|Baseline|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975073|NCT00881712|B2|Baseline|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975074|NCT00881712|B1|Baseline|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975075|NCT00881712|P3|Participant Flow|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975238|NCT00881335|O2|Outcome|Control Group|without any intervention
975779|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975076|NCT00881712|P2|Participant Flow|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975077|NCT00881712|P1|Participant Flow|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975078|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975079|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975080|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975081|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975082|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975083|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975084|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975085|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975086|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975087|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975088|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975089|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975090|NCT00881712|O3|Outcome|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975091|NCT00881712|O2|Outcome|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975092|NCT00881712|O1|Outcome|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975093|NCT00881712|E3|Reported Event|Patients Considered Resectable|"Proton radiation plus surgery~Patients considered resectable: Proton radiation at 2 cobalt gray per fraction. Re-evaluation performed between days 18-22 of treatment. If considered resectable after re-evaluation, radiotherapy will discontinue after a total of 50 cobalt gray equivalent and surgery will be performed."
975094|NCT00881712|E2|Reported Event|PET Positive Nodal Disease Measuring Less Than 15 mm|"Proton radiation~PET positive nodal disease measuring less than 15 mm: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 60 cobalt gray equivalent with concomitant weekly chemotherapy."
975095|NCT00881712|E1|Reported Event|PET Positive Nodal Disease Measuring 15 mm or Greater|"Proton radiation with concomitant chemotherapy~PET positive nodal disease measuring 15 mm or greater: Proton radiation at 2 cobalt gray equivalent per fraction to a total of 74 cobalt gray equivalent with concomitant weekly chemotherapy."
975096|NCT00881647|B3|Baseline|Total|Total of all reporting groups
975097|NCT00881647|B2|Baseline|Waitlist|Participants placed on a waitlist for 8 weeks.
975098|NCT00881647|B1|Baseline|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
975099|NCT00881647|P2|Participant Flow|Waitlist|Participants placed on a waitlist for 8 weeks.
975239|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975240|NCT00881335|O2|Outcome|Control Group|without any intervention
975100|NCT00881647|P1|Participant Flow|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
975101|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
975102|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
975103|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
975104|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
975105|NCT00881647|O2|Outcome|Waitlist|Participants placed on a waitlist for 8 weeks.
975106|NCT00881647|O1|Outcome|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
975107|NCT00881647|E2|Reported Event|Waitlist|Participants placed on a waitlist for 8 weeks.
975108|NCT00881647|E1|Reported Event|CBT-I|8-week course of Cognitive Behavioral Treatment for Insomnia (CBT-I): CBT-I includes strategies and instructions targeted toward improving the quality of sleep and resolving problems falling and staying asleep
975109|NCT00881621|B1|Baseline|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
975110|NCT00881621|P1|Participant Flow|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
975111|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
975112|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
975113|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
975114|NCT00881621|O1|Outcome|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
975115|NCT00881621|E1|Reported Event|Lapatinib and Capecitabine|"Treatment~Lapatinib and Capecitabine: Lapatinib 1250-mg PO daily one hour before or after meals Capecitabine 1000 mg/m2 PO twice daily on days 1-14 of 21-day cycle for a total of 8 cycles"
975116|NCT00881608|B6|Baseline|Total|Total of all reporting groups
975117|NCT00881608|B5|Baseline|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975118|NCT00881608|B4|Baseline|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975119|NCT00881608|B3|Baseline|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975120|NCT00881608|B2|Baseline|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975121|NCT00881608|B1|Baseline|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
975122|NCT00881608|P1|Participant Flow|All Subjects Enrolled|All subjects initiated treatment with placebo. Further information is not availasble due to premature termination of the study.
975123|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975124|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975125|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975126|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975127|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
975128|NCT00881608|O5|Outcome|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975157|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975129|NCT00881608|O4|Outcome|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975130|NCT00881608|O3|Outcome|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975131|NCT00881608|O2|Outcome|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975132|NCT00881608|O1|Outcome|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
975133|NCT00881608|E5|Reported Event|25 mg Proellex|"Fourth Cycle (25 mg)-Subjects, who have not experienced menses, will be dispensed five (5) 25 mg capsules of Proellex to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975134|NCT00881608|E4|Reported Event|12 mg Proellex|"Third Cycle (12 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed twenty (20) 3 mg capsules of Proellex to self-administer 4, 3 mg capsules for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975135|NCT00881608|E3|Reported Event|6 mg Proellex|"Second Cycle (6 mg)-Subjects, who have not experienced menses, will have their dose of Proellex escalated, and be dispensed ten (10) 3 mg capsules of Proellex to self-administer 2, 3 mg capsules each day for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975136|NCT00881608|E2|Reported Event|3 mg Proellex|"First Cycle (3 mg)- Five (5) 3 mg capsules of Proellex will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Proellex: Proellex, one 3, 6, 12 or 25 mg capsule daily for five days"
975137|NCT00881608|E1|Reported Event|Placebo|"Initiation-Placebo Cycle-Five (5) placebo capsules will be dispensed to subjects to self-administer for five days starting on cycle day 18.~Placebo: Placebo, 1 capsule daily for five days"
975138|NCT00881530|B7|Baseline|Total|Total of all reporting groups
975139|NCT00881530|B6|Baseline|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975140|NCT00881530|B5|Baseline|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975141|NCT00881530|B4|Baseline|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975142|NCT00881530|B3|Baseline|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975143|NCT00881530|B2|Baseline|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975144|NCT00881530|B1|Baseline|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975145|NCT00881530|P6|Participant Flow|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975146|NCT00881530|P5|Participant Flow|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975147|NCT00881530|P4|Participant Flow|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975148|NCT00881530|P3|Participant Flow|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975149|NCT00881530|P2|Participant Flow|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975150|NCT00881530|P1|Participant Flow|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975151|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975152|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975153|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975154|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975155|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975156|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975231|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975158|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975159|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975160|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975161|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975162|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975163|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975164|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975165|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975166|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975167|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975168|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975169|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975170|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975171|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975172|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975173|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975174|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975175|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975176|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975177|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975178|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975179|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975180|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975181|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975182|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975183|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975184|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975185|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975186|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975187|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975232|NCT00881335|O2|Outcome|Control Group|without any intervention
981352|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
975188|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975189|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975190|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975191|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975192|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975193|NCT00881530|O6|Outcome|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975194|NCT00881530|O5|Outcome|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975195|NCT00881530|O4|Outcome|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975196|NCT00881530|O3|Outcome|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975197|NCT00881530|O2|Outcome|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975198|NCT00881530|O1|Outcome|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975199|NCT00881530|E6|Reported Event|Sitaglipin + Metformin|Patients receive 100 mg Sitagliptin once daily in tablets added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975200|NCT00881530|E5|Reported Event|Empagliflozin 25 mg + Metformin|Patients receive 25 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975201|NCT00881530|E4|Reported Event|Empagliflozin 10 mg + Metformin|Patients receive 10 mg Empagliflozin in tablets once daily added to metformin background. Patients on metformin background (from trial NCT00749190) continued with their standard metformin therapy throughout the entire study.
975202|NCT00881530|E3|Reported Event|Metformin|Patients receive between 1000 and 2000 mg Metformin daily as monotherapy. Patients on metformin as active comparator (from trial NCT00789035) were to take their medication according to the instruction of their investigator, continuing the maximum tolerated dose determined in the preceding trial.
975203|NCT00881530|E2|Reported Event|Empagliflozin 25 mg|Patients receive 25 mg Empagliflozin in tablets once daily.
975204|NCT00881530|E1|Reported Event|Empagliflozin 10 mg|Patients receive 10 mg Empagliflozin in tablets once daily.
975205|NCT00881504|B1|Baseline|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
975206|NCT00881504|P1|Participant Flow|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
975207|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
975208|NCT00881504|O1|Outcome|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
975209|NCT00881504|E1|Reported Event|FOLFOX6 and Bevacizumab|"Treatment with modified FOLFOX6 and Bevacizumab~Modified FOLFOX6 and Bevacizumab: Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks"
975210|NCT00881465|B3|Baseline|Total|Total of all reporting groups
975211|NCT00881465|B2|Baseline|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
975233|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975234|NCT00881335|O2|Outcome|Control Group|without any intervention
975235|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975236|NCT00881335|O2|Outcome|Control Group|without any intervention
975212|NCT00881465|B1|Baseline|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
975213|NCT00881465|P2|Participant Flow|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
975214|NCT00881465|P1|Participant Flow|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
975215|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
975216|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
975217|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
975218|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
975219|NCT00881465|O2|Outcome|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
975220|NCT00881465|O1|Outcome|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
975221|NCT00881465|E2|Reported Event|Waitlist|"Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment.~Wait-list control: Waitlist Control. The participant and his/her parents will be instructed to not obtain treatment outside of the protocol or make medication changes/additions. This will be assessed through interview at the Post-Waitlist assessment."
975222|NCT00881465|E1|Reported Event|Cognitive-behavioral Therapy|"Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks. The first session will be held face-to-face to foster rapport. Sessions 1-4 will be held twice weekly; thereafter sessions will be held weekly. Sessions 1-3 are devoted to psychoeducation, treatment discussion, and hierarchy development. Sessions 4-10 involve CBT exercises specific to each youth.~Cognitive-behavioral therapy: Cognitive-Behavioral Therapy. The psychotherapy protocol will include 14 90-minute sessions of videophone administered CBT over 12 weeks."
975223|NCT00881335|B3|Baseline|Total|Total of all reporting groups
975224|NCT00881335|B2|Baseline|Control Group|without any intervention
975225|NCT00881335|B1|Baseline|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975226|NCT00881335|P2|Participant Flow|Control Group|without any intervention
975227|NCT00881335|P1|Participant Flow|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975228|NCT00881335|O2|Outcome|Control Group|without any intervention
975229|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975230|NCT00881335|O2|Outcome|Control Group|without any intervention
976153|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
975241|NCT00881335|O1|Outcome|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975242|NCT00881335|E2|Reported Event|Control Group|without any intervention
975243|NCT00881335|E1|Reported Event|Intervention Group|all the subjects received portable mucus clearance devices to do pulmonary function rehabilitation.
975244|NCT00881205|B3|Baseline|Total|Total of all reporting groups
975245|NCT00881205|B2|Baseline|Placebo|Matching the size, shape and color of rivastigmine patches.
975246|NCT00881205|B1|Baseline|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
975247|NCT00881205|P2|Participant Flow|Placebo|Matching the size, shape and color of rivastigmine patches.
975248|NCT00881205|P1|Participant Flow|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
975249|NCT00881205|O2|Outcome|Placebo|Matching the size, shape and color of rivastigmine patches.
975250|NCT00881205|O1|Outcome|Rivastigmine|5 and 10 cm² patch sizes (4,6mg/24h or 9,5mg/24h) of rivastigmine,
975251|NCT00881205|E3|Reported Event|Placebo|Placebo patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
975252|NCT00881205|E2|Reported Event|Rivastigmine|Rivastigmine patch arm with the application of one 5 cm² patch, followed by an increase to the target dose of 10 cm² patch size
975253|NCT00881205|E1|Reported Event|Total Patients|Total Patients
975254|NCT00880919|B4|Baseline|Total|Total of all reporting groups
975255|NCT00880919|B3|Baseline|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975256|NCT00880919|B2|Baseline|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975257|NCT00880919|B1|Baseline|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975258|NCT00880919|P3|Participant Flow|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975259|NCT00880919|P2|Participant Flow|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975260|NCT00880919|P1|Participant Flow|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975261|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975262|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975263|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975264|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975265|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975266|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975267|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975268|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975269|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975270|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975271|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975272|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975273|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975274|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975275|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975276|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975277|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975278|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975279|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975280|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975281|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975282|NCT00880919|O3|Outcome|Placebo (n=29)|"Equivalent number of placebo oral tablets taken daily for 8 weeks.~Placebo: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
975283|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33)|"Seroquel XR 300mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
975284|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33)|"Seroquel XR 150mg oral tablets taken daily for 8 weeks.~quetiapine extended-release: Seroquel XR 150mg/day vs Seroquel XR 300mg/day vs Placebo"
975285|NCT00880919|O3|Outcome|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975286|NCT00880919|O2|Outcome|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975287|NCT00880919|O1|Outcome|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975288|NCT00880919|E3|Reported Event|Placebo (n=29).|Equivalent number of placebo oral tablets taken daily for 8 weeks.
975289|NCT00880919|E2|Reported Event|Quetiapine XR 300 mg/Day (n=33),|Seroquel XR 300mg oral tablets taken daily for 8 weeks.
975290|NCT00880919|E1|Reported Event|Quetiapine XR 150 mg/Day (n=33),|Seroquel XR 150mg oral tablets taken daily for 8 weeks.
975291|NCT00880906|B3|Baseline|Total|Total of all reporting groups
975292|NCT00880906|B2|Baseline|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
975293|NCT00880906|B1|Baseline|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
981353|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
975294|NCT00880906|P2|Participant Flow|Group B Drug Therapy Only|Receives steroids and PPI only- Does not have esophageal dilation.
975295|NCT00880906|P1|Participant Flow|Group A Drug Therapy Plus Dilation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
975296|NCT00880906|O2|Outcome|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
975297|NCT00880906|O1|Outcome|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
975298|NCT00880906|E2|Reported Event|Group B Receives SOC Only|Receives steroids and PPI only- Does not have esophageal dilation.
975299|NCT00880906|E1|Reported Event|Group A Receives Routine Care and Esophageal Dilatation|"Group A receives steroids and PPI, (SOC) and esophageal dilation.~Esophageal dilation: The esophagus is stretched during the upper endoscopy using Maloney dilators or balloon dilatation."
975300|NCT00880763|B5|Baseline|Total|Total of all reporting groups
975301|NCT00880763|B4|Baseline|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975302|NCT00880763|B3|Baseline|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975303|NCT00880763|B2|Baseline|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975304|NCT00880763|B1|Baseline|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975305|NCT00880763|P4|Participant Flow|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975306|NCT00880763|P3|Participant Flow|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975307|NCT00880763|P2|Participant Flow|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975308|NCT00880763|P1|Participant Flow|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975309|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975310|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975311|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975312|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975313|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975314|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975315|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975316|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975317|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975318|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975319|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975320|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975321|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975322|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975323|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975324|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975325|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975326|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975327|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975328|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975329|NCT00880763|O4|Outcome|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975330|NCT00880763|O3|Outcome|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975331|NCT00880763|O2|Outcome|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975332|NCT00880763|O1|Outcome|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975333|NCT00880763|E4|Reported Event|Placebo + Peg-IFN + Ribavirin|Participants received placebo twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975334|NCT00880763|E3|Reported Event|Vaniprevir 1200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 600 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975335|NCT00880763|E2|Reported Event|Vaniprevir 600 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 300 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975336|NCT00880763|E1|Reported Event|Vaniprevir 200 mg + Peg-IFN + Ribavirin|Participants received vaniprevir 100 mg twice daily in combination with peg-IFN and ribavirin for 28 days. Participants continued peg-IFN and ribavirin through Week 6 or, at the investigators discretion, up to Week 72.
975337|NCT00880750|B3|Baseline|Total|Total of all reporting groups
975338|NCT00880750|B2|Baseline|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
975339|NCT00880750|B1|Baseline|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
975340|NCT00880750|P2|Participant Flow|Lanthanum Carbonate Chewable Tablet First|Chewable tablet formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
975341|NCT00880750|P1|Participant Flow|Lanthanum Carbonate Granules First|Granule formulation first at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4, a washout period, then chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4.
975342|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975343|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975344|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975345|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975346|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975347|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975348|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975349|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975464|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
975350|NCT00880750|O2|Outcome|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975351|NCT00880750|O1|Outcome|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975352|NCT00880750|E2|Reported Event|Lanthanum Carbonate Chewable Tablet|Chewable tablet formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975353|NCT00880750|E1|Reported Event|Lanthanum Carbonate Granules|Granule formulation at 1000 mg three times a day for 3 days and a single 1000 mg dose after breakfast on Day 4
975354|NCT00880698|B5|Baseline|Total|Total of all reporting groups
975355|NCT00880698|B4|Baseline|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975356|NCT00880698|B3|Baseline|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975357|NCT00880698|B2|Baseline|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975358|NCT00880698|B1|Baseline|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975359|NCT00880698|P4|Participant Flow|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975360|NCT00880698|P3|Participant Flow|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975361|NCT00880698|P2|Participant Flow|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975362|NCT00880698|P1|Participant Flow|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975363|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975364|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975365|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975366|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975367|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975368|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975369|NCT00880698|O2|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975370|NCT00880698|O1|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975371|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975372|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975373|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975463|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975374|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975375|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975376|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975377|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975378|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975379|NCT00880698|O4|Outcome|HIV-1 Infected Placebo|"HIV-1 infected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975380|NCT00880698|O3|Outcome|HIV-infected RotaTeq|"HIV-1 infected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975381|NCT00880698|O2|Outcome|HIV-uninfected Placebo|"HIV-1 uninfected participants receiving 3 doses of placebo at intervals of 4-10 weeks with the third dose administered by 32 weeks of age~Placebo: 2 mL solution"
975382|NCT00880698|O1|Outcome|HIV-uninfected RotaTeq|"HIV-1 uninfected participants receiving 3 doses of RotaTeq vaccine at intervals of 4-10 weeks with the third dose administered by 32 weeks of age.~RotaTeq: 2 mL solution of live reassortant rotaviruses, containing G1, G2, G3, G4 and P1A which contains a minimum of 2.0 - 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IUs per aggregate dose"
975383|NCT00880698|E4|Reported Event|HIV-1 Infected Placebo|
975384|NCT00880698|E3|Reported Event|HIV-1 Infected RotaTeq|
975385|NCT00880698|E2|Reported Event|HIV-1 Uninfected Placebo|
975386|NCT00880698|E1|Reported Event|HIV-1 Uninfected RotaTeq|
975387|NCT00880685|B1|Baseline|Memantine 10mg-30mg|10mg-30mg
975388|NCT00880685|P1|Participant Flow|Memantine 10mg-30mg|10mg-30mg
975389|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
975390|NCT00880685|O1|Outcome|Memantine|"Memantine 10-30mg~Memantine: 10-30mg, daily for 8 weeks"
975391|NCT00880685|O1|Outcome|Memantine 10mg-30mg|10mg-30mg
975392|NCT00880685|E3|Reported Event|Memantine 30mg|30mg
975393|NCT00880685|E2|Reported Event|Memantine 20mg|20mg
975394|NCT00880685|E1|Reported Event|Memantine 10mg|10mg
975395|NCT00880620|B5|Baseline|Total|Total of all reporting groups
975396|NCT00880620|B4|Baseline|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
975397|NCT00880620|B3|Baseline|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
975398|NCT00880620|B2|Baseline|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
975399|NCT00880620|B1|Baseline|Placebo|Placebo capsules were used
975400|NCT00880620|P4|Participant Flow|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
975401|NCT00880620|P3|Participant Flow|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
975402|NCT00880620|P2|Participant Flow|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
975403|NCT00880620|P1|Participant Flow|Placebo|Placebo capsules were used
975404|NCT00880620|O4|Outcome|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
975405|NCT00880620|O3|Outcome|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
975406|NCT00880620|O2|Outcome|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
975407|NCT00880620|O1|Outcome|Placebo|Placebo capsules were used
975408|NCT00880620|E4|Reported Event|IPX066 Dose Level 3|IPX066 capsules containing 390 mg levodopa and 97.5 mg carbidopa
975409|NCT00880620|E3|Reported Event|IPX066 Dose Level 2|IPX066 capsules containing 245 mg levodopa and 61.25 mg carbidopa
975410|NCT00880620|E2|Reported Event|IPX066 Dose Level 1|IPX066 capsules containing 145 mg levodopa and 36.25 mg carbidopa
975411|NCT00880620|E1|Reported Event|Placebo|Placebo capsules were used
975412|NCT00880581|B1|Baseline|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 in combination with local radiation as a therapy for lowgrade b-cell lymphoma.
975413|NCT00880581|P1|Participant Flow|PF-3512676|To assess the feasibility of using intra-tumoral PF-3512676 (CpG 7909 or ProMune) at 18 mg per week over 10 weeks in combination with local radiation [2 gray (2Gy) on each of Days 1 and 2] as a therapy for low-grade B-cell lymphoma.
975414|NCT00880581|O1|Outcome|PF-3512676|"Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.~PF-3512676: 18 mg injection~Local radiotherapy: 2 x 2 Gy"
975415|NCT00880581|O1|Outcome|PF-3512676|"Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.~PF-3512676: 18 mg injection~Local radiotherapy: 2 x 2 Gy"
976156|NCT00878826|E1|Reported Event|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
975416|NCT00880581|E1|Reported Event|PF-3512676|Patients will be treated with 18 mg PF-3512676 by intratumoral injection on day 2 following local radiotherapy, then weekly for a total of 10 injections over 10 weeks.
975417|NCT00880568|B10|Baseline|Total|Total of all reporting groups
975418|NCT00880568|B9|Baseline|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975419|NCT00880568|B8|Baseline|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975420|NCT00880568|B7|Baseline|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975421|NCT00880568|B6|Baseline|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975422|NCT00880568|B5|Baseline|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975423|NCT00880568|B4|Baseline|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
975424|NCT00880568|B3|Baseline|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
975425|NCT00880568|B2|Baseline|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
975426|NCT00880568|B1|Baseline|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
975427|NCT00880568|P9|Participant Flow|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975428|NCT00880568|P8|Participant Flow|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975429|NCT00880568|P7|Participant Flow|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975430|NCT00880568|P6|Participant Flow|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975431|NCT00880568|P5|Participant Flow|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975432|NCT00880568|P4|Participant Flow|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
975433|NCT00880568|P3|Participant Flow|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
975434|NCT00880568|P2|Participant Flow|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
975435|NCT00880568|P1|Participant Flow|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
975436|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975437|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975438|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975439|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975440|NCT00880568|O5|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975441|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
975442|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
975443|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
975444|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
975445|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975446|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975447|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975448|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975449|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975450|NCT00880568|O5|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975451|NCT00880568|O4|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975452|NCT00880568|O3|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975453|NCT00880568|O2|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975454|NCT00880568|O1|Outcome|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975455|NCT00880568|O4|Outcome|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
975456|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
975457|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
975458|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
975459|NCT00880568|O9|Outcome|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975460|NCT00880568|O8|Outcome|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975461|NCT00880568|O7|Outcome|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975462|NCT00880568|O6|Outcome|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975465|NCT00880568|O3|Outcome|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
975466|NCT00880568|O2|Outcome|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
975467|NCT00880568|O1|Outcome|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
975468|NCT00880568|E9|Reported Event|MK-1496 120 mg (28-Day Cycle)|Participants receiving MK-1496 120 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975469|NCT00880568|E8|Reported Event|MK-1496 100 mg (28-Day Cycle)|Participants receiving MK-1496 100 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975470|NCT00880568|E7|Reported Event|MK-1496 80 mg (28-Day Cycle)|Participants receiving MK-1496 80 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975471|NCT00880568|E6|Reported Event|MK-1496 40 mg (28-Day Cycle)|Participants receiving MK-1496 40 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975472|NCT00880568|E5|Reported Event|MK-1496 20 mg (28-Day Cycle)|Participants receiving MK-1496 20 mg on Days 1, 3, 8, 10, 15, and 17 of each 28-day cycle
975473|NCT00880568|E4|Reported Event|MK-1496 120 mg (21-Day Cycle)|Participants receiving MK-1496 120 mg on Day 1 of each 21-day cycle
975474|NCT00880568|E3|Reported Event|MK-1496 80 mg (21-Day Cycle)|Participants receiving MK-1496 80 mg on Day 1 of each 21-day cycle
975475|NCT00880568|E2|Reported Event|MK-1496 40 mg (21-Day Cycle)|Participants receiving MK-1496 40 mg on Day 1 of each 21-day cycle
975476|NCT00880568|E1|Reported Event|MK-1496 20 mg (21-Day Cycle)|Participants receiving MK-1496 20 mg on Day 1 of each 21-day cycle
975477|NCT00880555|B4|Baseline|Total|Total of all reporting groups
975478|NCT00880555|B3|Baseline|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
975479|NCT00880555|B2|Baseline|Arm 2: Control|Elderly controls without memory impairment
975480|NCT00880555|B1|Baseline|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
975481|NCT00880555|P6|Participant Flow|Non-AD Dementia|Other causes of dementia
975482|NCT00880555|P5|Participant Flow|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
975483|NCT00880555|P4|Participant Flow|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
975484|NCT00880555|P3|Participant Flow|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
975485|NCT00880555|P2|Participant Flow|Arm 2: Control|Elderly controls without memory impairment
975486|NCT00880555|P1|Participant Flow|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
975487|NCT00880555|O3|Outcome|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
975488|NCT00880555|O2|Outcome|Arm 2: Control|Elderly controls without memory impairment
975489|NCT00880555|O1|Outcome|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
975490|NCT00880555|E6|Reported Event|Non-AD Dementia|Other causes of dementia
975491|NCT00880555|E5|Reported Event|Intoxicated|Individuals who appeared to be intoxicated at baseline evaluation
975492|NCT00880555|E4|Reported Event|CIND|Individuals with cognitive impairment who did not meet criteria for MCI or dementia
975493|NCT00880555|E3|Reported Event|Arm 3: Mild Alzheimer Disease|Patients with mild Alzheimer disease (but preserved routine activities of daily living)
975494|NCT00880555|E2|Reported Event|Arm 2: Control|Elderly controls without memory impairment
975495|NCT00880555|E1|Reported Event|Arm 1: Non-Dementia Memory Disorder|Elderly patients with non-dementia memory disorder (mild cognitive impairment)
975496|NCT00880542|B1|Baseline|Sorafenib + Ifosfamide|
975497|NCT00880542|P1|Participant Flow|Sorafenib + Ifosfamide|
975498|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
975499|NCT00880542|O1|Outcome|Sorafenib + Ifosfamide|
975500|NCT00880542|E1|Reported Event|Sorafenib + Ifosfamide|
975501|NCT00880425|B1|Baseline|Chronic Daily Headache|Patients who fulfilled criteria for Chronic Migraine, New Daily Persistent Headache , Chronic Post Traumatic Headache or Chronic Tension Type Headache
975502|NCT00880425|P2|Participant Flow|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975503|NCT00880425|P1|Participant Flow|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975504|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975505|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975506|NCT00880425|O2|Outcome|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975507|NCT00880425|O1|Outcome|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975508|NCT00880425|E2|Reported Event|Headache Every Day Continuous|Subjects with Headache every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975509|NCT00880425|E1|Reported Event|Headache Every Day (HED) Non-continuous|Subjects with Headche every day included those with a diagnosis of Chronic Migraine, New Daily Persistent Headache, Chronic Post Traumatic Headache and Chronic TensionType Headache
975510|NCT00880360|B1|Baseline|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
975722|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975511|NCT00880360|P1|Participant Flow|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
975512|NCT00880360|O1|Outcome|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
975513|NCT00880360|E1|Reported Event|Ontak|Ontak : Patients will be treated with Ontak at 12 µg/kg monthly as long as they meet response criteria.
975514|NCT00880334|B3|Baseline|Total|Total of all reporting groups
975515|NCT00880334|B2|Baseline|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
975516|NCT00880334|B1|Baseline|Vandetanib & Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
975517|NCT00880334|P2|Participant Flow|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
975518|NCT00880334|P1|Participant Flow|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
975519|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
975520|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
975521|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
975522|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
975523|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
975524|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Vandetanib: taken orally once a day, every day"
975525|NCT00880334|O2|Outcome|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
975526|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
975527|NCT00880334|O2|Outcome|Placebo and Docetaxel|"Placebo orally and docetaxel intravenously~Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Placebo: Taken orally once a day every day"
975528|NCT00880334|O1|Outcome|Vandetanib and Docetaxel|"Docetaxel: Given intravenously on Day 1 of each 21-day cycle~Vandetanib: taken orally once a day, every day"
975529|NCT00880334|E2|Reported Event|Placebo and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Placebo: Taken orally once a day every day
975530|NCT00880334|E1|Reported Event|Vandetanib and Docetaxel|Docetaxel: Given intravenously on Day 1 of each 21-day cycle Vandetanib: taken orally once a day, every day
975531|NCT00880269|B3|Baseline|Total|Total of all reporting groups
975532|NCT00880269|B2|Baseline|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975533|NCT00880269|B1|Baseline|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975534|NCT00880269|P2|Participant Flow|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975535|NCT00880269|P1|Participant Flow|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975536|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975537|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975538|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975539|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975540|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975541|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975542|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975543|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975544|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975545|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975546|NCT00880269|O2|Outcome|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975547|NCT00880269|O1|Outcome|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975548|NCT00880269|E2|Reported Event|Stratum B|patients with refractory AML initially diagnosed as AML secondary to myelodysplastic syndrome (MDS)/antecedent hematologic disorder (AHD) received 60 mg of panobinostat per day on three discontinuous days per week.
975549|NCT00880269|E1|Reported Event|Stratum A|patients with refractory acute myelogenous leukemia (AML) initially diagnosed as de novo AML received 60 mg of panobinostat per day on three discontinuous days per week.
975550|NCT00880256|B1|Baseline|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
975551|NCT00880256|P1|Participant Flow|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
975552|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
975553|NCT00880256|O1|Outcome|Mindfulness-Based Stress Reduction (MBSR)|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
975554|NCT00880256|E1|Reported Event|MBSR|Patients who undergo mindfulness-based stress reduction will fill out measures of IBS severity before and after the mindfulness course.
975555|NCT00880230|B1|Baseline|Scuba Iliac Stent System|"Device: Scuba™ Iliac stent~Scuba Iliac Stent System: The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975556|NCT00880230|P1|Participant Flow|Scuba Iliac Stent System|"Device: Scuba Iliac Stent~Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975557|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975558|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975559|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975560|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975561|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975562|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975563|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975564|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975565|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975566|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975567|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975568|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975569|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975570|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975571|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975572|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975573|NCT00880230|O1|Outcome|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975574|NCT00880230|E1|Reported Event|Scuba Iliac Stent System|"Device: Scuba™ iliac stent~Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system."
975575|NCT00880191|B3|Baseline|Total|Total of all reporting groups
975576|NCT00880191|B2|Baseline|Placebo|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > placebo: Given orally
975577|NCT00880191|B1|Baseline|Gabapentin|Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy. > dexamethasone: Given orally > gabapentin: Given orally
975578|NCT00880191|P2|Participant Flow|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975579|NCT00880191|P1|Participant Flow|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975580|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975581|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975582|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975583|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975584|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975585|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975586|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975587|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975588|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975589|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975590|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975591|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975592|NCT00880191|O2|Outcome|Placebo|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral placebo once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral placebo either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> placebo: Given orally"
975593|NCT00880191|O1|Outcome|Gabapentin|"Patients receive oral dexamethasone with 5HT3 receptor antagonist and oral gabapentin once daily on day 1 of chemotherapy. Patients then receive oral dexamethasone twice daily with or without 5HT3 receptor antagonist on days 2-4, and oral gabapentin either two or three times daily on days 2-5 of chemotherapy.~> dexamethasone: Given orally~> gabapentin: Given orally"
975594|NCT00880191|E2|Reported Event|Placebo|placebo: Given orally
975595|NCT00880191|E1|Reported Event|Gabapentin|gabapentin: Given orally
975596|NCT00880165|B3|Baseline|Total|Total of all reporting groups
975597|NCT00880165|B2|Baseline|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975598|NCT00880165|B1|Baseline|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975599|NCT00880165|P2|Participant Flow|Home Unattended Testing|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
975600|NCT00880165|P1|Participant Flow|In-laboratory Testing|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be prescribed continuous positive airway pressure treatment."
976157|NCT00878800|B6|Baseline|Total|Total of all reporting groups
975601|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975602|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975603|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975604|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975605|NCT00880165|O2|Outcome|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975606|NCT00880165|O1|Outcome|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975607|NCT00880165|E2|Reported Event|Arm 2|"Home unattended testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975608|NCT00880165|E1|Reported Event|Arm 1|"In-laboratory testing~Continuous positive airway pressure apparatus: Veterans randomized to both arms who are diagnosed with obstructive sleep apnea will be started on treatment with continuous positive airway pressure."
975609|NCT00880100|B1|Baseline|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975610|NCT00880100|P1|Participant Flow|Ultrase® MT12|Patients received usual pancreatic enzymes therapy for 9 to 14 days during baseline phase followed by Ultrase® MT12 capsules orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975611|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975612|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975613|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975614|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975615|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975616|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975617|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975618|NCT00880100|O1|Outcome|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975619|NCT00880100|E1|Reported Event|Ultrase® MT12|Ultrase® MT12 capsules were given orally daily based on investigator's discretion to a maximum dose of 2,500 lipase units per kilogram (kg) body weight per meal or snack for 19 to 24 days during the treatment phase. Total maximum dose was not to exceed 10,000 lipase units/kg/day.
975620|NCT00880022|B3|Baseline|Total|Total of all reporting groups
975621|NCT00880022|B2|Baseline|Arm, Trunck and Chest Compression|
975622|NCT00880022|B1|Baseline|Arm Compression Only|
975623|NCT00880022|P2|Participant Flow|Arm, Trunk and Chest Compression|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
975624|NCT00880022|P1|Participant Flow|Arm Compression Only|Participants received a total of 30 treatments lasting up to approximately one hour per day for 30 days. Treatment One was provided under study staff supervision. Treatments Two through Thirty were self-administered, at home.
975625|NCT00880022|O2|Outcome|Arm, Trunck and Chest Compression|
975626|NCT00880022|O1|Outcome|Arm Compression Only|
975627|NCT00880022|E2|Reported Event|Arm, Trunck and Chest Compression|
975628|NCT00880022|E1|Reported Event|Arm Compression Only|
975629|NCT00880009|B1|Baseline|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
981354|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
975630|NCT00880009|P1|Participant Flow|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975631|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975632|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975633|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975634|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975635|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975636|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975637|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975638|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975639|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975640|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975641|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975642|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975643|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975644|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975645|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975646|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975647|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975648|NCT00880009|O2|Outcome|Letrozole (Part 2)|Letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975649|NCT00880009|O1|Outcome|Bosutinib + Letrozole (Part 2)|Four bosutinib 100 mg tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975650|NCT00880009|E1|Reported Event|Bosutinib + Letrozole (Part 1)|Four bosutinib 100 milligram (mg) tablets, equivalent to 400 mg bosutinib along with letrozole 2.5 mg tablet orally once daily until disease progression, unacceptable toxicity or withdrawal of consent occurred.
975651|NCT00879996|B3|Baseline|Total|Total of all reporting groups
975652|NCT00879996|B2|Baseline|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
975653|NCT00879996|B1|Baseline|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
975654|NCT00879996|P2|Participant Flow|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
975655|NCT00879996|P1|Participant Flow|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
975656|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
975657|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
975658|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
975659|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
975660|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
975661|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
975662|NCT00879996|O2|Outcome|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day divided in 2-4 doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
975663|NCT00879996|O1|Outcome|Methadone|Methadone 10-60 mg per day divided in 2-4 doses for 6 months
975664|NCT00879996|E2|Reported Event|Buprenorphine/Naloxone|Buprenorphine 4-16 mg per day in 2-4 divided doses for 6 months (using tablets of buprenorphine/naloxone:4/1 mg)
975665|NCT00879996|E1|Reported Event|Methadone|Methadone 10-60 mg per day in 2-4 divided doses for 6 months
975666|NCT00879970|B4|Baseline|Total|Total of all reporting groups
975667|NCT00879970|B3|Baseline|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975668|NCT00879970|B2|Baseline|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975669|NCT00879970|B1|Baseline|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975670|NCT00879970|P5|Participant Flow|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
975671|NCT00879970|P4|Participant Flow|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
975672|NCT00879970|P3|Participant Flow|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975673|NCT00879970|P2|Participant Flow|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975674|NCT00879970|P1|Participant Flow|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975675|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975676|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975677|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975678|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975679|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975680|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975681|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975682|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975683|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975684|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975685|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975686|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975687|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975688|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975689|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975690|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975691|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975692|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975693|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975694|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975695|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975696|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975697|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975698|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975699|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975700|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975701|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975702|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975703|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975704|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975705|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975706|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975707|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975708|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975709|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975710|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975711|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975712|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975713|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975714|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975715|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975716|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975717|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975718|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975719|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975720|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975721|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975723|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975724|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975725|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975726|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975727|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975728|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975729|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975730|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975731|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975732|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975733|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975734|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975735|NCT00879970|O5|Outcome|VITAMIN D|1,000 IU/day administered for a mean duration of 162 days.
975736|NCT00879970|O4|Outcome|VITAMIN D PLACEBO|Vitamin D placebo administered for a mean duration of 162 days.
975737|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975738|NCT00879970|O2|Outcome|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975739|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975740|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
975741|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
975742|NCT00879970|O3|Outcome|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975743|NCT00879970|O2|Outcome|Pioglitzaone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975744|NCT00879970|O1|Outcome|Placebo|PLACEBO Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975745|NCT00879970|O5|Outcome|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
975746|NCT00879970|O4|Outcome|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days.
975747|NCT00879970|O3|Outcome|Rosiglitazone (RSG)|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975748|NCT00879970|O2|Outcome|Pioglitazone (PIO)|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975749|NCT00879970|O1|Outcome|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975750|NCT00879970|E5|Reported Event|Vitamin D|1,000 IU/day administered for a mean duration of 162 days.
975751|NCT00879970|E4|Reported Event|Vitamin D Placebo|Vitamin D placebo administered for a mean duration of 162 days
975752|NCT00879970|E3|Reported Event|Rosiglitazone|RSG tablet was administered in the dose of 4-8 mg OD for a mean duration of 162 days.
975753|NCT00879970|E2|Reported Event|Pioglitazone|PIO tablet was administered in the dose of 30-45 milligrams (mg) OD for a mean duration of 162 days.
975754|NCT00879970|E1|Reported Event|Placebo|Matching placebo tablet was administered once a day (OD) for a mean duration of 162 days.
975755|NCT00879879|B1|Baseline|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
975756|NCT00879879|P1|Participant Flow|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
975757|NCT00879879|O1|Outcome|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
975758|NCT00879879|E1|Reported Event|Losartan|"50 mg tablets of losartan taken daily by mouth for 1 year~losartan : 50 mg losartan taken daily by mouth in capsule form for 1 year"
975759|NCT00879814|B5|Baseline|Total|Total of all reporting groups
975760|NCT00879814|B4|Baseline|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975761|NCT00879814|B3|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975762|NCT00879814|B2|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975763|NCT00879814|B1|Baseline|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975764|NCT00879814|P4|Participant Flow|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975765|NCT00879814|P3|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975766|NCT00879814|P2|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975767|NCT00879814|P1|Participant Flow|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975768|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975769|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975770|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975771|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975772|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975773|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975774|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975775|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975776|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975777|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975778|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975780|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975781|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975782|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975783|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975784|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975785|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975786|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975787|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975788|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975789|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975790|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975791|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975792|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975793|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975794|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975795|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975796|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975797|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975798|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975799|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975800|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975801|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975802|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975803|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975804|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975805|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975806|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975807|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975808|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975809|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975810|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975811|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975812|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975813|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975814|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975815|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975816|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975817|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975818|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975819|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975820|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975821|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975822|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975823|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975824|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975825|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975826|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975827|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975828|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975829|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975830|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975831|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975832|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975833|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975834|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975835|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975836|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975837|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975838|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975839|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975840|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975841|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975842|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975843|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975844|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975845|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975846|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975847|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
976629|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
975848|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975849|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975850|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975851|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975852|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975853|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975854|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975855|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975856|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975857|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975858|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975859|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975860|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975861|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975862|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975863|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975864|NCT00879814|O4|Outcome|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975865|NCT00879814|O3|Outcome|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975866|NCT00879814|O2|Outcome|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975867|NCT00879814|O1|Outcome|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975868|NCT00879814|E4|Reported Event|Tdap/Normal Saline (Control)|Tdap was given at month 0 and Saline was given at Month 2 and 6
975869|NCT00879814|E3|Reported Event|rLP2086 200 mcg|Given on a 0, 2-, 6- month schedule
975870|NCT00879814|E2|Reported Event|rLP2086 120 mcg|Given on a 0, 2-, 6- month schedule
975871|NCT00879814|E1|Reported Event|rLP2086 60mcg|Given on a 0, 2-, 6- month schedule
975872|NCT00879775|B3|Baseline|Total|Total of all reporting groups
975873|NCT00879775|B2|Baseline|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975874|NCT00879775|B1|Baseline|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975875|NCT00879775|P2|Participant Flow|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975876|NCT00879775|P1|Participant Flow|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975877|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975878|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975879|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975880|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975881|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975882|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975883|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975884|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975885|NCT00879775|O2|Outcome|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975886|NCT00879775|O1|Outcome|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975887|NCT00879775|E2|Reported Event|Placebo|Intravenous injections of 100ml of normal saline over 1 hour
975888|NCT00879775|E1|Reported Event|Caffeine|Intravenous injections of 200mg of caffeine with 100ml of normal saline over 1 hour
975889|NCT00879710|B3|Baseline|Total|Total of all reporting groups
975890|NCT00879710|B2|Baseline|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975891|NCT00879710|B1|Baseline|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975892|NCT00879710|P4|Participant Flow|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
975893|NCT00879710|P3|Participant Flow|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with ezetimibe for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of simvastatin."
975939|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
981355|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
975894|NCT00879710|P2|Participant Flow|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Patients with T2DM were treated only with oral sulfonylurea drugs and/or biguanides and/or thiazolidinediones. Subjects with T2DM were excluded if they were on insulin or other injectable agents. All subjects were interviewed by S.K. to ensure classifications of T1DM and T2DM were accurate by history.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
975895|NCT00879710|P1|Participant Flow|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Subjects with T1DM were ascertained based on ketosis at the time of diagnosis and/or being treated with insulin since the diagnosis.~All subjects were interviewed by S.K. (a board certified endocrinologist) to ensure classifications of T1DM and T2DM were accurate by history and physical exam.~This group started with simvastatin for 6 weeks followed by 4 week washout. They were then placed on 6 weeks of ezetimibe."
975896|NCT00879710|O2|Outcome|Subjects With Type 2 Diabetes Mellitus|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975897|NCT00879710|O1|Outcome|Subjects With Type 1 Diabetes Mellitus,|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975898|NCT00879710|E4|Reported Event|Subjects With Type 2 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,~4 weeks washout period~Simvastatin 40 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975899|NCT00879710|E3|Reported Event|Subjects With Type 1 Diabetes mellitus_Ezet_Simva|"Ezetimibe 10 mg tablet by month daily for 6 weeks,~4 weeks washout period~Simvastatin 40 mg by month for 6 weeks~simvastatin: Subjects will be started on either simvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975900|NCT00879710|E2|Reported Event|Subjects With Type 2 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975901|NCT00879710|E1|Reported Event|Subjects With Type 1 Diabetes mellitus_Simva_Ezet|"Simvastatin 40 mg tablet by month daily for 6 weeks,~4 weeks washout period~Ezetimibe 10 mg by month for 6 weeks~simvastatin: Subjects will be started on eithersimvastatin or ezetimibe(we will alternate the subjects so that half the sample will initially be treated with simvastatin and half will be started on ezetimibe). The dose of Simvastatin (Merck) is 40 mg orally at nighttime for 6 weeks and the dose of ezetimibe (Schering-Plough) is 10 mg taken orally once a day. Subjects will be instructed on low-fat diet (therapeutic life style changes diet) recommended by American Heart Association by the bionutritionist."
975902|NCT00879697|B3|Baseline|Total|Total of all reporting groups
975903|NCT00879697|B2|Baseline|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
975904|NCT00879697|B1|Baseline|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
975905|NCT00879697|P2|Participant Flow|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 seconds (s) of each exercise bout.
975906|NCT00879697|P1|Participant Flow|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
975907|NCT00879697|O2|Outcome|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
975940|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975908|NCT00879697|O1|Outcome|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
975909|NCT00879697|E2|Reported Event|Walking Training|Patients who performed walking training. Walking training program was performed using a treadmill. In each session, patients performed fifteen 2-minutes bouts of exercise followed by a 2-minutes rest interval, as previously described. Walking speed was set in order to induce perceived exertion of 11 to 13 and claudication pain in the last 30 s of each exercise bout.
975910|NCT00879697|E1|Reported Event|Strength Training|Patients who performed strength training. Strength training program consisted of 8 exercises (leg press, crunches, unilateral knee extension, seated row, unilateral knee flexion, seated bench press, calf raises on leg press, and seated back extension). In each exercise, subjects performed 3 sets of 10 repetitions with a 2-minutes interval between sets and exercises.
975911|NCT00879684|B1|Baseline|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2, administered once-weekly in a 4-week cycle.
975912|NCT00879684|P7|Participant Flow|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
975913|NCT00879684|P6|Participant Flow|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975914|NCT00879684|P5|Participant Flow|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975915|NCT00879684|P4|Participant Flow|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975916|NCT00879684|P3|Participant Flow|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975917|NCT00879684|P2|Participant Flow|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975918|NCT00879684|P1|Participant Flow|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975919|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
975920|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975921|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975922|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975923|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975924|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975925|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975926|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
975927|NCT00879684|O1|Outcome|CVX-060 (Stage 1 and 2)|CVX-060 0.3, 1, 3, 6, 12, 15 mg/kg of body weight intravenous infusion in Stage 1 and CVX-060 15 mg/kg of body weight intravenous infusion in Stage 2 administered once-weekly in a 4-week cycle.
975928|NCT00879684|O1|Outcome|CVX-060 (Stage 1)|All participants who received 0.3, 1, 3, 6, 12, 15 mg/kg intravenous infusion once-weekly in Stage 1. Participants who discontinued treatment at any time were followed for 6 weeks to assess toxicity, pharmacokinetics (elimination half-life), and immunogenicity.
975929|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
975930|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975931|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975932|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975933|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975934|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975935|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
975936|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975937|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975938|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
981356|NCT00862082|O1|Outcome|PR104|
975941|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
975942|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975943|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975944|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975945|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975946|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975947|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
975948|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975949|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975950|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975951|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975952|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975953|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
975954|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975955|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975956|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975957|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975958|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975959|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1 and 2)|CVX-060 15 mg/kg of body weight intravenous infusion in both Stage 1 and Stage 2 administered once-weekly in a 4-week cycle.
975960|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975961|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975962|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975963|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975964|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975965|NCT00879684|O7|Outcome|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
975966|NCT00879684|O6|Outcome|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975967|NCT00879684|O5|Outcome|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975968|NCT00879684|O4|Outcome|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975969|NCT00879684|O3|Outcome|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975970|NCT00879684|O2|Outcome|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975971|NCT00879684|O1|Outcome|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975972|NCT00879684|E7|Reported Event|CVX-060 15 mg/kg (Stage 2)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in expanded cohort stage (Stage 2) after completion of dose escalation stage.
975973|NCT00879684|E6|Reported Event|CVX-060 15 mg/kg (Stage 1)|CVX-060 15 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975974|NCT00879684|E5|Reported Event|CVX-060 12 mg/kg (Stage 1)|CVX-060 12 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975975|NCT00879684|E4|Reported Event|CVX-060 6 mg/kg (Stage 1)|CVX-060 6 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
976154|NCT00878826|E3|Reported Event|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
975976|NCT00879684|E3|Reported Event|CVX-060 3 mg/kg (Stage 1)|CVX-060 3 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975977|NCT00879684|E2|Reported Event|CVX-060 1 mg/kg (Stage 1)|CVX-060 1 mg/kg of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975978|NCT00879684|E1|Reported Event|CVX-060 0.3 mg/kg (Stage 1)|CVX-060 0.3 milligram per kilogram (mg/kg) of body weight intravenous infusion administered once-weekly in a 4-week cycle in dose escalation stage (Stage 1).
975979|NCT00879645|B5|Baseline|Total|Total of all reporting groups
975980|NCT00879645|B4|Baseline|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
975981|NCT00879645|B3|Baseline|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
975982|NCT00879645|B2|Baseline|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
975983|NCT00879645|B1|Baseline|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
975984|NCT00879645|P4|Participant Flow|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
975985|NCT00879645|P3|Participant Flow|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
975986|NCT00879645|P2|Participant Flow|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
975987|NCT00879645|P1|Participant Flow|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
975988|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
975989|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
975990|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
975991|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
975992|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
975993|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
975994|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
975995|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
975996|NCT00879645|O4|Outcome|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
975997|NCT00879645|O3|Outcome|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
975998|NCT00879645|O2|Outcome|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
975999|NCT00879645|O1|Outcome|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
976000|NCT00879645|E4|Reported Event|Sodium Sulfide - Severe Cohort|Severe RI cohort received sodium sulfide intravenously at 1.0 mg/kg/hr for 3 hours
976001|NCT00879645|E3|Reported Event|Sodium Sulfide - Moderate Cohort|Moderate RI cohort received sodium sulfide intravenously at 1.5 mg/kg/hr for 3 hours
976002|NCT00879645|E2|Reported Event|Sodium Sulfide - Healthy Cohort|Healthy subjects received soduim sufide intravenously at 1.5 mg/kg/hr for 3 hours
976003|NCT00879645|E1|Reported Event|Sodium Sulfide - Mild Cohort|Mild renal impairment (RI) Cohort administered 1.5 mg/kg/hr infusion of Sodium sulfide intravenously for 3 hours.
976004|NCT00879619|B1|Baseline|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976005|NCT00879619|P1|Participant Flow|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO once daily (QD) on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976006|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976007|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976008|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
981357|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
976009|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976010|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976011|NCT00879619|O1|Outcome|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976012|NCT00879619|E1|Reported Event|Chemotherapy and Enzyme Inhibitor|"Patients receive docetaxel IV over 60 minutes on day 1, prednisone PO BID on days 1-21, and sunitinib malate PO QD on days 2-15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive sunitinib malate PO QD on days 1-28. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.~prednisone : Given PO~docetaxel : Given IV~sunitinib malate : Given PO"
976013|NCT00879411|B1|Baseline|Telmisartan, Hydrochlorothiazide|
976014|NCT00879411|P1|Participant Flow|Telmisartan, Hydrochlorothiazide|
976015|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
976016|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
976017|NCT00879411|O1|Outcome|Telmisartan, Hydrochlorothiazide|
976018|NCT00879411|E1|Reported Event|Telmisartan, Hydrochlorothiazide|
976019|NCT00879398|B1|Baseline|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976020|NCT00879398|P1|Participant Flow|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976021|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976022|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976023|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976024|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976025|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976026|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976027|NCT00879398|O1|Outcome|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976028|NCT00879398|E1|Reported Event|Toviaz|Participants were administered with Toviaz as part of routine care. The use and dosage recommendations for Toviaz were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
976029|NCT00879359|B1|Baseline|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
976030|NCT00879359|P1|Participant Flow|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m^2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
976031|NCT00879359|O1|Outcome|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
976032|NCT00879359|O1|Outcome|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
976033|NCT00879359|O1|Outcome|Maintenance With Bevacizumab|carboplatin, paclitaxel, and bevacizumab: All patients enrolled will receive carboplatin AUC 5 plus paclitaxel 175 mg/m2 (135 mg/m2 if prior radiation to greater than 25% of bone marrow) plus bevacizumab 15 mg/kg every 3 weeks.
976110|NCT00878969|B3|Baseline|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
976034|NCT00879359|E1|Reported Event|Maintenance Therapy With Bevacizumab|A phase II trial was conducted in patients with measurable disease. Paclitaxel (175 mg/m2/3 hours), carboplatin (AUC 5) and bevacizumab (15 mg/kg) were administered q21 days. Patients in a complete response after 6 or 8 cycles received maintenance therapy with bevacizumab 15 mg/kg q21 days for 16 cycles.
976035|NCT00879333|B3|Baseline|Total|Total of all reporting groups
976036|NCT00879333|B2|Baseline|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976037|NCT00879333|B1|Baseline|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976038|NCT00879333|P2|Participant Flow|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976039|NCT00879333|P1|Participant Flow|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976040|NCT00879333|O2|Outcome|Everolimus 5mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 5 mg tablet of everolimus once daily. One of the 11 patients on the 5 mg arm, only had a pre-dose evaluable sample.
976041|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976042|NCT00879333|O2|Outcome|Everolimus 5 mg/Day|Patients were randomized to receive everolimus + BSC. Patients orally took 1 5 mg tablet of everolimus once daily. Two of the 18 patients on the 5 mg arm, only had pre-dose evaluable samples.
976043|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976044|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976045|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976046|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976047|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976048|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976049|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976050|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976051|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976052|NCT00879333|O2|Outcome|Placebo|All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976111|NCT00878969|B2|Baseline|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 6 mg of ramipril taken orally on a daily basis for 18 months
976155|NCT00878826|E2|Reported Event|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
976053|NCT00879333|O1|Outcome|Everolimus 10mg/Daily|All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
976054|NCT00879333|E2|Reported Event|Placebo|Placebo
976055|NCT00879333|E1|Reported Event|Everolimus 10mg / Daily|Everolimus 10mg / daily
976056|NCT00879255|B3|Baseline|Total|Total of all reporting groups
976057|NCT00879255|B2|Baseline|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
976058|NCT00879255|B1|Baseline|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
976059|NCT00879255|P2|Participant Flow|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
976060|NCT00879255|P1|Participant Flow|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
976061|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
976062|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
976063|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
976064|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
976065|NCT00879255|O2|Outcome|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
976066|NCT00879255|O1|Outcome|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
976067|NCT00879255|E2|Reported Event|Face-to-Face CPT|"The control arm is the group condition that received the CPT treatment via face-to-face traditional modality as compared to the experimental condition which is via videoteleconferencing modality.~Cognitive Processing Therapy Group In-Person is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference.~Cognitive Processing Therapy Group In-Person: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, in-person, rather than through videoteleconference."
976112|NCT00878969|B1|Baseline|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
976068|NCT00879255|E1|Reported Event|Videoteleconferencing CPT|"The experimental arm is the group condition that received the CPT treatment via videoteleconferencing modality as compared to the experimental condition which is via face-to-face traditional modality.~Cognitive Processing Therapy Group Videoteleconference is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference.~Cognitive Processing Therapy Group Videoteleconference: Cognitive Processing Group Therapy is delivered to male combat veterans who have been diagnosed with PTSD, through videoteleconference."
976069|NCT00879229|B3|Baseline|Total|Total of all reporting groups
976070|NCT00879229|B2|Baseline|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976071|NCT00879229|B1|Baseline|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976072|NCT00879229|P2|Participant Flow|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976073|NCT00879229|P1|Participant Flow|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976074|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976075|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976076|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976077|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976078|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976079|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976080|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976081|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976082|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976083|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976084|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976085|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976086|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976087|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976088|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976089|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976090|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976091|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976092|NCT00879229|O2|Outcome|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976093|NCT00879229|O1|Outcome|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976094|NCT00879229|E2|Reported Event|Placebo|Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks.
976095|NCT00879229|E1|Reported Event|Ambrisentan|Participants were randomized to receive ambrisentan treatment for 56 weeks
976096|NCT00879190|B3|Baseline|Total|Total of all reporting groups
976097|NCT00879190|B2|Baseline|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
976098|NCT00879190|B1|Baseline|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
976099|NCT00879190|P2|Participant Flow|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
976100|NCT00879190|P1|Participant Flow|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
976101|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
976102|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
976103|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
976104|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
976105|NCT00879190|O2|Outcome|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
976106|NCT00879190|O1|Outcome|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
976107|NCT00879190|E2|Reported Event|Ampicillin/Gentamicin|Ampicillin/gentamicin: Gentamicin 1.5mg/kg intravenously every 8 hours plus ampicillin 2 grams intravenously every 6 hours until 24 hours post delivery.
976108|NCT00879190|E1|Reported Event|Unasyn (Ampicillin/Sulbactam)|Unasyn: Unasyn 3 grams intravenously every 6 hours, plus intravenous normal saline placebo dose every 8 hours until 24 hours post delivery.
976109|NCT00878969|B4|Baseline|Total|Total of all reporting groups
976152|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
976113|NCT00878969|P3|Participant Flow|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
976114|NCT00878969|P2|Participant Flow|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
976115|NCT00878969|P1|Participant Flow|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
976116|NCT00878969|O3|Outcome|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
976117|NCT00878969|O2|Outcome|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
976118|NCT00878969|O1|Outcome|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
976119|NCT00878969|E3|Reported Event|Placebo|matching placebo taken orally on a daily basis for 1 week followed by matching placebo taken orally on a daily basis for 18 months
976120|NCT00878969|E2|Reported Event|Ramipril|2.5 mg of ramipril (ACE inhibitor) taken orally on a daily basis for 1 week followed by 5 mg of ramipril taken orally on a daily basis for 18 months
976121|NCT00878969|E1|Reported Event|Valsartan|80 mg of valsartan (ARB) taken orally on a daily basis for 1 week followed by 160 mg of valsartan taken orally on a daily basis for 18 months
976122|NCT00878878|B3|Baseline|Total|Total of all reporting groups
976123|NCT00878878|B2|Baseline|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
976124|NCT00878878|B1|Baseline|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
976125|NCT00878878|P2|Participant Flow|Placebo Control First, Then Followed by Optison Product|Placebo Control (5% Dextrose) was used first, then the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
976126|NCT00878878|P1|Participant Flow|Optison First, Then Followed by Placebo Control|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first, than the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
976127|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
976128|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
976129|NCT00878878|O2|Outcome|Elevated Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with elevated pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
976130|NCT00878878|O1|Outcome|Normal Pulmonary Artery Systolic Pressure (PASP)|Observe subjects with normal pulmonary artery systolic pressure (PASP)as measured by any adverse events. The number of participants were stratified based on a screening pulmonary artery systolic pressure (PASP).
976131|NCT00878878|O2|Outcome|Placebo Control (5% Dextrose) Given First, Then Optison|Placebo Control (5% Dextrose) was given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP). There was a 15 minute interval between the injections.
976132|NCT00878878|O1|Outcome|Optison Given First, Then Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) was given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
976133|NCT00878878|E2|Reported Event|Placebo Control (5% Dextrose) First Followed by the Optison|Placebo Control (5% Dextrose) given first followed by the Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP. There was a 15 minute interval between the injections.
976134|NCT00878878|E1|Reported Event|Optison Product First Followed by Placebo Control (5%Dextrose)|Optison product (Perflutren Protein-Type A Microspheres Injectable Suspension, USP) given first followed by the Placebo Control (5% Dextrose). There was a 15 minute interval between the injections.
976135|NCT00878826|B4|Baseline|Total|Total of all reporting groups
976136|NCT00878826|B3|Baseline|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
976137|NCT00878826|B2|Baseline|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
976138|NCT00878826|B1|Baseline|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
976139|NCT00878826|P3|Participant Flow|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
976140|NCT00878826|P2|Participant Flow|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
976141|NCT00878826|P1|Participant Flow|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
976142|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
976143|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
976144|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
976145|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
976146|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
976147|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
976148|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
976149|NCT00878826|O2|Outcome|Enoxaparin 1 mg Per kg Daily|1 mg/kg Enoxaparin injection daily
976150|NCT00878826|O1|Outcome|Enoxaparin 40 mg Per Day|40 mg Enoxaparin injection daily
976151|NCT00878826|O3|Outcome|Enoxaparin 60 mg Per Day|60 mg Enoxaparin injection daily - Pre prescribed regimen
976158|NCT00878800|B5|Baseline|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976159|NCT00878800|B4|Baseline|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976160|NCT00878800|B3|Baseline|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
976161|NCT00878800|B2|Baseline|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
976162|NCT00878800|B1|Baseline|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
976163|NCT00878800|P5|Participant Flow|MTD Expansion: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976164|NCT00878800|P4|Participant Flow|Cohort 4: BelDox IV (1000/75)|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976165|NCT00878800|P3|Participant Flow|Cohort 3: BelDox IV (800/75)|PXD101 and doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
976166|NCT00878800|P2|Participant Flow|Cohort 2: BelDox IV (600/75)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
976167|NCT00878800|P1|Participant Flow|Cohort 1: BelDox IV (600/50)|PXD101 and doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
976168|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
976169|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
976170|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
976171|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
976172|NCT00878800|O2|Outcome|Day 5 - Belinostat 1000 mg/m² and Doxorubicin 75 mg/m²|Belinostat combined with doxorubicin
976173|NCT00878800|O1|Outcome|Day 4 - Belinostat 1000 mg/m²|Belinostat alone
976174|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976175|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976176|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976177|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976178|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976179|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976180|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976181|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976182|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976183|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976184|NCT00878800|O2|Outcome|MTD Expansion|PXD101 and doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976185|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976186|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976187|NCT00878800|O1|Outcome|Dose Escalation|PXD101 and doxorubicin: 5-day PXD101 600-800-1000 mg/m² combined with doxorubicin 50-75 mg/m²
976188|NCT00878800|E5|Reported Event|MTD Expansion: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976189|NCT00878800|E4|Reported Event|Cohort 4: BelDox IV (1000/75)|PXD101 + doxorubicin: 5-day PXD101 1000 mg/m² combined with doxorubicin 75 mg/m²
976190|NCT00878800|E3|Reported Event|Cohort 3: BelDox IV (800/75)|PXD101 + doxorubicin: 5-day PXD101 800 mg/m² combined with doxorubicin 75 mg/m²
976191|NCT00878800|E2|Reported Event|Cohort 2: BelDox IV (600/75)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 75 mg/m²
976192|NCT00878800|E1|Reported Event|Cohort 1: BelDox IV (600/50)|PXD101 + doxorubicin: 5-day PXD101 600 mg/m² combined with doxorubicin 50 mg/m²
976193|NCT00878722|B9|Baseline|Total|Total of all reporting groups
976194|NCT00878722|B8|Baseline|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976195|NCT00878722|B7|Baseline|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976196|NCT00878722|B6|Baseline|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976197|NCT00878722|B5|Baseline|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976198|NCT00878722|B4|Baseline|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976199|NCT00878722|B3|Baseline|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976200|NCT00878722|B2|Baseline|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976201|NCT00878722|B1|Baseline|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976202|NCT00878722|P8|Participant Flow|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976282|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976203|NCT00878722|P7|Participant Flow|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976204|NCT00878722|P6|Participant Flow|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976205|NCT00878722|P5|Participant Flow|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976206|NCT00878722|P4|Participant Flow|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976207|NCT00878722|P3|Participant Flow|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976208|NCT00878722|P2|Participant Flow|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976209|NCT00878722|P1|Participant Flow|Arm A, Step 1|PXD101 (belinostat) 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976210|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
976211|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
976212|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
976213|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
976214|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
976215|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
976216|NCT00878722|O3|Outcome|Arm B, Cycle 1 Day 1 and Day 2|
976217|NCT00878722|O2|Outcome|Arm A, Cycle 1 Day 5|
976218|NCT00878722|O1|Outcome|Arm A, Cycle 1 Day 4|
976219|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976220|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976221|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976222|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976223|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976224|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976225|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976226|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976227|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976228|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976229|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976230|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976231|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976232|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976233|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976234|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976235|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976236|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976237|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976238|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976239|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976240|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976241|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976242|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976243|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976244|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976245|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976246|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976247|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976248|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976249|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976250|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976251|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976252|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976253|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976254|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976255|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976256|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976257|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976258|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976259|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976260|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976261|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976262|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976263|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976264|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976265|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976266|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976267|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976268|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976269|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976270|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976271|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976272|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976273|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976274|NCT00878722|O1|Outcome|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976275|NCT00878722|O8|Outcome|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976276|NCT00878722|O7|Outcome|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976277|NCT00878722|O6|Outcome|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976278|NCT00878722|O5|Outcome|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976279|NCT00878722|O4|Outcome|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976280|NCT00878722|O3|Outcome|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976281|NCT00878722|O2|Outcome|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976889|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976283|NCT00878722|E8|Reported Event|Arm B, Step 9|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 7.5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976284|NCT00878722|E7|Reported Event|Arm B, Step 8|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 24 and 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976285|NCT00878722|E6|Reported Event|Arm B, Step 7|"PXD101 administered by continuous intravenous infusion over 48 hours, dose 1000 mg/m²/48 hours~Idarubicin added at 5 mg/m² after 48 hours. Further cycles will be administered q 14 d for up to 6 cycles"
976286|NCT00878722|E5|Reported Event|Arm B, Steps 1-6|PXD101 administered by continuous intravenous infusion over 24-48 hours, doses 25 mg/m²/24 hours to 800 mg/m²/24 hours for 48 hours
976287|NCT00878722|E4|Reported Event|Arm A, Step 4|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 10 mg/m²/d
976288|NCT00878722|E3|Reported Event|Arm A, Step 3|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On days 4 and 5, Idarubicin 7.5 mg/m²/d
976289|NCT00878722|E2|Reported Event|Arm A, Step 2|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 10 mg/m²
976290|NCT00878722|E1|Reported Event|Arm A, Step 1|PXD101 1000 mg/m²/d for 5 consecutive days every 3 weeks. On day 5, Idarubicin 5 mg/m²
976291|NCT00878605|B5|Baseline|Total|Total of all reporting groups
976292|NCT00878605|B4|Baseline|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976293|NCT00878605|B3|Baseline|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976294|NCT00878605|B2|Baseline|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976295|NCT00878605|B1|Baseline|Placebo|"Placebo control~Placebo: Placebo control"
976296|NCT00878605|P4|Participant Flow|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 15mg + 20 mg zinc orally per day for 12 weeks."
976297|NCT00878605|P3|Participant Flow|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 9mg + 20 mg zinc orally per day for 12 weeks."
976298|NCT00878605|P2|Participant Flow|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose~Participants received Cyclo-Z gel 3mg + 20 mg zinc orally per day for 12 weeks."
976299|NCT00878605|P1|Participant Flow|Arm 1|"Placebo control~Placebo: Placebo control~Participants received placebo tablet orally daily for 12 weeks."
976300|NCT00878605|O4|Outcome|Cyclo-Z Gel 15mg + 20 mg Zinc|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976301|NCT00878605|O3|Outcome|Cyclo-Z Gel 9mg + 20 mg Zinc|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976302|NCT00878605|O2|Outcome|Cyclo-Z Gel 3mg + 20 mg Zinc|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976303|NCT00878605|O1|Outcome|Placebo|"Placebo control~Placebo: Placebo control"
976304|NCT00878605|E4|Reported Event|Arm 4|"Active medication high dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976305|NCT00878605|E3|Reported Event|Arm 3|"Active medication efficacy dose~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976306|NCT00878605|E2|Reported Event|Arm 2|"Active medication~Cyclo-Z: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose"
976307|NCT00878605|E1|Reported Event|Arm 1|"Placebo control~Placebo: Placebo control"
976308|NCT00878553|B5|Baseline|Total|Total of all reporting groups
976309|NCT00878553|B4|Baseline|Sequence 4|15mg SKP-1041, 10mg SKP-1041, 20mg SKP-1041, Placebo
976310|NCT00878553|B3|Baseline|Sequence 3|20mg SKP-1041, Placebo, 15mg SKP-1041, 10mg SKP-1041
976311|NCT00878553|B2|Baseline|Sequence 2|Placebo, 10mg SKP-1041, 20mg SKP-1041, 15mg SKP-1041
976312|NCT00878553|B1|Baseline|Sequence 1|10mg SKP-1041, 15mg SKP-1041, Placebo, 20mg SKP-1041
976313|NCT00878553|P5|Participant Flow|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976314|NCT00878553|P4|Participant Flow|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976315|NCT00878553|P3|Participant Flow|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976316|NCT00878553|P2|Participant Flow|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment. Two placebo tablets were administered orally at bedtime for two consecutive nights during the Sleep Study, after which patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned for the next treatment in their randomized sequence.
976397|NCT00878228|P2|Participant Flow|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
976317|NCT00878553|P1|Participant Flow|Baseline: All Randomized Patients|"The second screening visit consisted of 2 consecutive sleep laboratory nights of placebo pretreatment and full PSG recordings. The 67 patients who met entry criteria were then randomized to four treatment sequences with their screening night mean PSG parameters defined as their baseline.~This trial was comprised of 2 study periods: Sleep and Pharmacokinetic (PK). Each of 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence for the Sleep Study. For each of these treatment arms, two double-dummy tablets were administered at bedtime for two consecutive nights. An additional (third) dosing night allowed for pharmacokinetic characterization of the investigational zaleplon formulation. In this PK Substudy, patient's plasma concentrations were measured after a single dose in parallel group design."
976318|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976319|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976320|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976321|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976322|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976323|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976324|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976325|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976326|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976327|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976328|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976329|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976330|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976331|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976332|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976333|NCT00878553|O3|Outcome|20 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered two 10 mg SKP-1041 tablets at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976334|NCT00878553|O2|Outcome|15 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 15 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976335|NCT00878553|O1|Outcome|10 mg SKP-1041|The fourth and final treatment period included a third night at the site during which all patients continued to receive the same study medication as on the first 2 nights of this treatment period. Patients randomized to this group were administered one placebo and one 10 mg SKP-1041 tablet at bedtime for the third time. Blood was drawn from all patients for PK analyses at specific time intervals.
976336|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976337|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976338|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10 mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976339|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976340|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976341|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976342|NCT00878553|O2|Outcome|10 mg SKP=1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976343|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976344|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976345|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976346|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976398|NCT00878228|P1|Participant Flow|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
976347|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976348|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976349|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976350|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976351|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976352|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976353|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976354|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976355|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976356|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976357|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976358|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976359|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976360|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976361|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976362|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976363|NCT00878553|O1|Outcome|Placebo|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two placebo tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976364|NCT00878553|O4|Outcome|20 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 20mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. Two 10 mg SKP-1041 tablets were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976365|NCT00878553|O3|Outcome|15 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 15mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 15 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976366|NCT00878553|O2|Outcome|10 mg SKP-1041|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive 10mg of the investigational zaleplon delayed and sustained release SKP-1041 tablets. One 10 mg SKP-1041 tablet and one placebo tablet were administered orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976367|NCT00878553|O1|Outcome|Placebo (Sugar Pill)|Each patient was assigned at some point in their randomized crossover sequence of four treatment arms to receive placebo treatment in place of the investigational zaleplon delayed and sustained release SKP-1041 tablets. These patients received two placebo tablets orally at bedtime for each of two consecutive nights during the Sleep Study. Afterward, patients were released from the sleep laboratory, washed out at home for 4-7 days, and returned to the sleep lab for the next treatment in their randomized sequence.
976368|NCT00878553|E4|Reported Event|20mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
976369|NCT00878553|E3|Reported Event|15mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
976370|NCT00878553|E2|Reported Event|10 mg|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
976371|NCT00878553|E1|Reported Event|Placebo|Each of the 67 patients was randomly assigned a sequence of the four treatment arms, washed out, and then crossed over to the next assigned treatment in their sequence.
976372|NCT00878501|B4|Baseline|Total|Total of all reporting groups
976373|NCT00878501|B3|Baseline|Placebo Control|Placebo bid for 4 weeks
976374|NCT00878501|B2|Baseline|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
976375|NCT00878501|B1|Baseline|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
976376|NCT00878501|P3|Participant Flow|Placebo Control|Placebo bid for 4 weeks
976377|NCT00878501|P2|Participant Flow|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
976378|NCT00878501|P1|Participant Flow|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
976379|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
976380|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
976381|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
976382|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
976383|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
976384|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
976385|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
976386|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
976387|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
976388|NCT00878501|O3|Outcome|Placebo Control|Placebo bid for 4 weeks
976389|NCT00878501|O2|Outcome|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
976390|NCT00878501|O1|Outcome|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
976391|NCT00878501|E3|Reported Event|Placebo Control|Placebo bid for 4 weeks
976392|NCT00878501|E2|Reported Event|Experimental 30 mg|AZD1386 30 mg twice a day (bid) for 4 weeks
976393|NCT00878501|E1|Reported Event|Experimental 90 mg|AZD1386 90 mg twice a day (bid) for 4 weeks
976394|NCT00878228|B3|Baseline|Total|Total of all reporting groups
976395|NCT00878228|B2|Baseline|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
976396|NCT00878228|B1|Baseline|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
976399|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
976400|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
976401|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
976402|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
976403|NCT00878228|O2|Outcome|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
976404|NCT00878228|O1|Outcome|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
976405|NCT00878228|E2|Reported Event|Control Group|The control group received IV ondansetron intraoperatively and then oral placebo tablets (for 2 days).
976406|NCT00878228|E1|Reported Event|Study Group|The study group received intraoperative IV ondansetron and also postoperative oral ondansetron tablets (8 mg each day for two days).
976407|NCT00877929|B3|Baseline|Total|Total of all reporting groups
976408|NCT00877929|B2|Baseline|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976409|NCT00877929|B1|Baseline|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976410|NCT00877929|P2|Participant Flow|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976411|NCT00877929|P1|Participant Flow|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976412|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976413|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976414|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976415|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976416|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976417|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976418|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976419|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976420|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976421|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976422|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976423|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976424|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976425|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976426|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976427|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976428|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976429|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976430|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976431|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976432|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976433|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976434|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976435|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976579|NCT00877799|E4|Reported Event|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
976436|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976437|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976438|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976439|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976440|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976441|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976442|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976443|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976444|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976445|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976446|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976447|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976448|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976449|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976450|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976451|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976452|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976453|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976454|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976455|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976456|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976457|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976458|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976459|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976460|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976461|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976462|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976463|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976464|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976465|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976466|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976467|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976468|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976469|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976470|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976471|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976472|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976473|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976474|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976475|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976476|NCT00877929|O2|Outcome|Amlodipine 5 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976477|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976478|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976479|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976480|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976481|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976482|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976483|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976484|NCT00877929|O2|Outcome|Amlodipine 5 mg|
976485|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
976486|NCT00877929|O2|Outcome|Amlodipine 5 mg|
976487|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 5 mg|
976488|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976489|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976490|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976491|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976492|NCT00877929|O2|Outcome|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976493|NCT00877929|O1|Outcome|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976494|NCT00877929|E2|Reported Event|Amlodipine 10 mg|Once daily Placebo / Amlodipine 5 mg (A5) tablet for first 2 weeks then Placebo / Amlodipine 10 mg (A10) tablet for 6 weeks.
976495|NCT00877929|E1|Reported Event|Telmisartan 80 mg + Amlodipine 10 mg|Once daily Telmisartan 80 mg (T80) / Amlodipine 5 mg (A5) tablet for first 2 weeks then Telmisartan 80 mg (T80) / Amlodipine 10 mg (A10) tablet for 6 weeks.
976496|NCT00877890|B3|Baseline|Total|Total of all reporting groups
976497|NCT00877890|B2|Baseline|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976498|NCT00877890|B1|Baseline|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976499|NCT00877890|P2|Participant Flow|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976500|NCT00877890|P1|Participant Flow|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976501|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
976502|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
976503|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
976504|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
976505|NCT00877890|O4|Outcome|Exenatide Twice Daily No SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) not using concomitant SU at screening
976506|NCT00877890|O3|Outcome|Exenatide Once Weekly No SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening
976507|NCT00877890|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks) using concomitant SU at screening
976508|NCT00877890|O1|Outcome|Exenatide Once Weekly With SU|Subjects with subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening
976509|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976510|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976580|NCT00877799|E3|Reported Event|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) administered 24 hours after surgery (Day 1)
976511|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976512|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976513|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976514|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976515|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976516|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976517|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976518|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976519|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976520|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976521|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976522|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976523|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976524|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976525|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976526|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976527|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976528|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976529|NCT00877890|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976530|NCT00877890|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976531|NCT00877890|E2|Reported Event|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 20 weeks)
976532|NCT00877890|E1|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week
976533|NCT00877877|B1|Baseline|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976534|NCT00877877|P1|Participant Flow|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976535|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976536|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976537|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976538|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976539|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976540|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976541|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976542|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976543|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976544|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976545|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976546|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976547|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976548|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976549|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976550|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976551|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976552|NCT00877877|O1|Outcome|Cervarix Group|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule.
976553|NCT00877877|E6|Reported Event|Cervarix Group From Month 108 to Month 120|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 108 until Month 120.
976554|NCT00877877|E5|Reported Event|Cervarix Group From Month 96 to Month 108|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 96 until Month 108.
976555|NCT00877877|E4|Reported Event|Cervarix Group From Month 84 to Month 96|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 84 until Month 96.
976556|NCT00877877|E3|Reported Event|Cervarix Group From Month 72 to Month 84|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 72 until Month 84.
976557|NCT00877877|E2|Reported Event|Cervarix Group From Month 60 Until Month 72|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 60 until Month 72.
976558|NCT00877877|E1|Reported Event|Cervarix Group From Month 48 Until Month 60|Subjects in the Cervarix Group of the primary study (NCT00196924), who had then received 3 doses of Cervarix™ vaccine intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 month vaccination schedule and for whom serious adverse events were collected from Month 48 until Month 60.
976559|NCT00877799|B6|Baseline|Total|Total of all reporting groups
976560|NCT00877799|B5|Baseline|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours post-surgery (Day 0)
976561|NCT00877799|B4|Baseline|Cohort 2: Placebo|Matched placebo administered within 3 hours post-surgery (Day 0)
976562|NCT00877799|B3|Baseline|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
976563|NCT00877799|B2|Baseline|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
976564|NCT00877799|B1|Baseline|Cohort 1: Placebo|Matched placebo administered 24 hours post-surgery (Day 1)
976565|NCT00877799|P5|Participant Flow|Cohort 2: CR845 0.040 mg/kg|CR845 (0.040 mg/kg) single i.v. dose administered within 3 hours after surgery (Day 0)
976566|NCT00877799|P4|Participant Flow|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery (Day 0)
976567|NCT00877799|P3|Participant Flow|Cohort 1: CR845 0.024 mg/kg|CR845 (0.024 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
976568|NCT00877799|P2|Participant Flow|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) single i.v. dose administered 24 hours post-surgery (Day 1)
976569|NCT00877799|P1|Participant Flow|Cohort 1: Placebo|Matched Placebo administered 24 hours post-surgery (Day 1)
976570|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
976571|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
976572|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
976573|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
976574|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|CR845 administered within 3 hours after surgery
976575|NCT00877799|O1|Outcome|Cohort 2: Placebo|Matched Placebo administered within 3 hours after surgery
976576|NCT00877799|O2|Outcome|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
976577|NCT00877799|O1|Outcome|Cohort 2: Placebo|Cohort 2: Matched Placebo administered after surgery on Day 0 when subjects were medically stable and awake with a moderate to severe pain intensity score (i.e., 5 to 8 inclusive on an 11-point NRS) recorded within 3 hr after awakening from anesthesia.
976578|NCT00877799|E5|Reported Event|Cohort 2: CR845 0.040 mg/kg|Cohort 2: CR845 (0.040 mg/kg) administered within 3 hours after surgery (Day 0)
976581|NCT00877799|E2|Reported Event|Cohort 1: CR845 0.008 mg/kg|CR845 (0.008 mg/kg) administered 24 hours after surgery (Day 1)
976582|NCT00877799|E1|Reported Event|Cohort 1: Placebo|Matched placebo administered 24 hours after surgery (Day 1)
976583|NCT00877773|B1|Baseline|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
976584|NCT00877773|P1|Participant Flow|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
976585|NCT00877773|O1|Outcome|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
976586|NCT00877773|E1|Reported Event|Temsirolimus|Temsirolimus 25 mg by vein over 60 minutes on Days 1, 8, 15, and 22 of each 4-week study cycle.
976587|NCT00877604|B3|Baseline|Total|Total of all reporting groups
976588|NCT00877604|B2|Baseline|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule"
976589|NCT00877604|B1|Baseline|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
976590|NCT00877604|P2|Participant Flow|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
976591|NCT00877604|P1|Participant Flow|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
976592|NCT00877604|O2|Outcome|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
976593|NCT00877604|O1|Outcome|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
976594|NCT00877604|E2|Reported Event|Placebo|"excipient lactose~Placebo: identical placebo by oral route at the same dosing schedule composed of excipient lactose"
976595|NCT00877604|E1|Reported Event|TUDCA|"tauroursodeoxycholic acid di-hydrate~tauroursodeoxycholic acid (TUDCA): Oral route at the dose of 1 g b.i.d. (2 g daily) for 1 year"
976596|NCT00877487|B1|Baseline|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
976597|NCT00877487|P2|Participant Flow|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
976598|NCT00877487|P1|Participant Flow|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
976599|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
976600|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
976601|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
976602|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
976603|NCT00877487|O2|Outcome|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
976604|NCT00877487|O1|Outcome|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
976605|NCT00877487|E2|Reported Event|Placebo|Subjects who previously were receiving SPD489 are now only getting placebo.
976606|NCT00877487|E1|Reported Event|SPD489|Subjects receive SPD489 at 30, 50, or 70 mg/day.
976607|NCT00877448|B8|Baseline|Total|Total of all reporting groups
976608|NCT00877448|B7|Baseline|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
976609|NCT00877448|B6|Baseline|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
976610|NCT00877448|B5|Baseline|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
976611|NCT00877448|B4|Baseline|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
976612|NCT00877448|B3|Baseline|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
976613|NCT00877448|B2|Baseline|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
976614|NCT00877448|B1|Baseline|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
976615|NCT00877448|P7|Participant Flow|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
976616|NCT00877448|P6|Participant Flow|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
976617|NCT00877448|P5|Participant Flow|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
976618|NCT00877448|P4|Participant Flow|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
976619|NCT00877448|P3|Participant Flow|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
976620|NCT00877448|P2|Participant Flow|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
976621|NCT00877448|P1|Participant Flow|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution (PBS) injected twice with the interval of 21 days between them.
976622|NCT00877448|O7|Outcome|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
976623|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
976624|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
976625|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
976626|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
976627|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
976628|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
976630|NCT00877448|O6|Outcome|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
976631|NCT00877448|O5|Outcome|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
976632|NCT00877448|O4|Outcome|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
976633|NCT00877448|O3|Outcome|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
976634|NCT00877448|O2|Outcome|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
976635|NCT00877448|O1|Outcome|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
976636|NCT00877448|E7|Reported Event|Multimeric-001 125 Mcg|Multimeric-001 125 mcg in PBS administered once only.
976637|NCT00877448|E6|Reported Event|Adjuvanted Multimeric-001 500 Mcg|Adjuvanted Multimeric-001 500 mcg injected twice with the interval of 21 days
976638|NCT00877448|E5|Reported Event|Multimeric-001 in PBS 500 Mcg|Multimeric-001 in PBS 500 mcg injected twice with the interval of 21 days
976639|NCT00877448|E4|Reported Event|Adjuvanted PBS|Adjuvanted PBS (Placebo) in the volume of 0.2 ml is injected twice to 10 participants with the interval of 21 days between them.
976640|NCT00877448|E3|Reported Event|PBS (Placebo)|0.2 ml of Phosphate Buffered Saline is injected twice with the interval of 21 days between them to 10 participants.
976641|NCT00877448|E2|Reported Event|Adjuvanted Multimeric -001 250 Mcg|Adjuvanted Multimeric -001 250 mcg injected twice with the interval of 21 days between the injections.10 participants in total.
976642|NCT00877448|E1|Reported Event|Multimeric-001 250 Mcg in PBS|Multimeric - 001 250 mcg in Phosphate Buffered Solution injected twice with the interval of 21 days between them.
976643|NCT00877383|B3|Baseline|Total|Total of all reporting groups
976644|NCT00877383|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976645|NCT00877383|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976646|NCT00877383|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976647|NCT00877383|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976648|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976649|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976650|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976651|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976702|NCT00877032|P5|Participant Flow|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976703|NCT00877032|P4|Participant Flow|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976704|NCT00877032|P3|Participant Flow|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976652|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976653|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976654|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976655|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976656|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976657|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976658|NCT00877383|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976659|NCT00877383|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976660|NCT00877383|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976661|NCT00877383|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single-dose dry-powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
976662|NCT00877370|B1|Baseline|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
976663|NCT00877370|P1|Participant Flow|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
976664|NCT00877370|O1|Outcome|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
976665|NCT00877370|E1|Reported Event|Ertapenem|"Subjects will receive ertapenem while receiving CVVHD~ertapenem : One gram ertapenem will be infused intravenously in subjects receiving continuous hemodialysis (CVVHD). Pharmacokinetic sampling in this study will occur with the first dose of ertapenem. While on CVVHD, enrolled subjects will receive ertapenem 1 g intravenously administered over 30 minutes. Two blood samples (5 mL each) will be collected from the arterial (pre-diafilter) port of the CVVHD tubing at time 0 (baseline), ½ hour (end of infusion), 1, 1½, 2, 3, 6, 12, and 24 hours. Effluent (5 mL) will also be collected at these predefined time points from the effluent port of the CVVHD tubing. If ertapenem is discontinued after the first dose then additional samples will be collected at 36 and 48 hours, otherwise ertapenem will be administered as soon as the 24 hour sample is obtained."
976666|NCT00877071|B1|Baseline|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
976667|NCT00877071|P1|Participant Flow|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
976668|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
976669|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
976670|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
976671|NCT00877071|O1|Outcome|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
976672|NCT00877071|E1|Reported Event|LC Drug Eluting Bead, Regional Chemoembolization|"Use of LC Drug-Eluting Beads for chemoembolization will provide a method for downstaging patients with hepatocellular carcinoma which is not amenable to surgical resection or local ablative therapy to liver transplant eligibility~LC Bead loaded with doxorubicin: LC Bead is a new product specifically designed for TACE. LC Bead microspheres will be loaded with between 50-100mg of doxorubicin for each of several TACE procedures. The bead will utilize embolic induced ischemia as well as local chemotherapy in an effort to downstage unresectable HCC to liver transplantation"
976673|NCT00877058|B4|Baseline|Total|Total of all reporting groups
976674|NCT00877058|B3|Baseline|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
976705|NCT00877032|P2|Participant Flow|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976706|NCT00877032|P1|Participant Flow|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976707|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976675|NCT00877058|B2|Baseline|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
976676|NCT00877058|B1|Baseline|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
976677|NCT00877058|P3|Participant Flow|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
976678|NCT00877058|P2|Participant Flow|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings. http://www.vardalinstitutet.net/livslots.pdf.
976679|NCT00877058|P1|Participant Flow|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
976680|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
976681|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
976682|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
976683|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
976708|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976709|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976710|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976711|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976712|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976684|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
976685|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
976686|NCT00877058|O3|Outcome|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
976687|NCT00877058|O2|Outcome|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
976688|NCT00877058|O1|Outcome|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
976689|NCT00877058|E3|Reported Event|3 Control Group|The control group had access to the ordinary range of services if requested from the urban districts for the aged. The aim of the municipal provision of care for the older persons is to ensure the ability to live as independently as possible. This includes remaining in their homes. When an older person in Sweden has difficulties managing independently, she or he can apply for assistance from the district. The extent of such support is subject to an assessment of needs and includes meals on wheels, help with cleaning and shopping, assistance with personal care, safety alarms and transportation service. The older person are also offered healthcare, provided either by municipal home help or home medical care services.
976690|NCT00877058|E2|Reported Event|2 Senior Meetings|The intervention senior meetings comprised four weekly meetings with about six participants in each group. The main purpose was to focus on two different topics: 1) information about the ageing process and its consequences and 2) provision of tools and strategies for solving problems that can arise in the home environment. A follow-up home visit took place two to three weeks after the group sessions were completed. The group meetings were led either by an occupational therapist, a registered nurse, a physiotherapist or a qualified social worker, all of whom spoke about their particular dimension of aging. They jointly planned and carried out the intervention and were responsible for their specific part of the meetings. T The participants' experiences formed the basis of the meetings. A booklet was especially produced for the meetings, which includes texts that cover different areas of health, discussed at each of the meetings (table 1). http://www.vardalinstitutet.net/livslots.pdf.
976691|NCT00877058|E1|Reported Event|1 Preventive Home Visits|This intervention included a single home visit made by either a nurse, a physiotherapist, a qualified social worker or an occupational therapist. Participants received verbal and written information/advice about what the districts could provide. The preventive home visit was guided by a protocol, which included an opportunity for individuals to further elaborate on certain elements. The visit lasted between one and a half to two hours.
976692|NCT00877032|B8|Baseline|Total|Total of all reporting groups
976693|NCT00877032|B7|Baseline|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976694|NCT00877032|B6|Baseline|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976695|NCT00877032|B5|Baseline|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976696|NCT00877032|B4|Baseline|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976697|NCT00877032|B3|Baseline|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976698|NCT00877032|B2|Baseline|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976699|NCT00877032|B1|Baseline|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976700|NCT00877032|P7|Participant Flow|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976701|NCT00877032|P6|Participant Flow|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
981358|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
976713|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976714|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976715|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976716|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976717|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976718|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976719|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976720|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976721|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976722|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976723|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976724|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976725|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976726|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976727|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976728|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976729|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976730|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976731|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976732|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976733|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976734|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976735|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976736|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976737|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976738|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976739|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976740|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976741|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976742|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976743|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976744|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976745|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976746|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976747|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976748|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976749|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976750|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976751|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976752|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976753|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976754|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976755|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976756|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976757|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976758|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
977025|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
976759|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976760|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976761|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976762|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976763|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976764|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976765|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976766|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976767|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976768|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976769|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976770|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976771|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976772|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976773|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976774|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976775|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976776|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976777|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976778|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976779|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976780|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976781|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976782|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976783|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976784|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976785|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976786|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976787|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976788|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976789|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976790|NCT00877032|O7|Outcome|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976791|NCT00877032|O6|Outcome|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976792|NCT00877032|O5|Outcome|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976793|NCT00877032|O4|Outcome|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976794|NCT00877032|O3|Outcome|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976795|NCT00877032|O2|Outcome|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976796|NCT00877032|O1|Outcome|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976797|NCT00877032|E7|Reported Event|Placebo|Single intravenous infusion dose of placebo matched to RN6G on Day 1.
976798|NCT00877032|E6|Reported Event|RN6G 40 mg/kg|Single intravenous infusion dose of RN6G 40 mg/kg of body weight over 120 to 160 minutes on Day 1.
976799|NCT00877032|E5|Reported Event|RN6G 20 mg/kg|Single intravenous infusion dose of RN6G 20 mg/kg of body weight over 120 to 160 minutes on Day 1.
976800|NCT00877032|E4|Reported Event|RN6G 10 mg/kg|Single intravenous infusion dose of RN6G 10 mg/kg of body weight over 120 to 160 minutes on Day 1.
976801|NCT00877032|E3|Reported Event|RN6G 3 mg/kg|Single intravenous infusion dose of RN6G 3 mg/kg of body weight over 120 to 160 minutes on Day 1.
976802|NCT00877032|E2|Reported Event|RN6G 1 mg/kg|Single intravenous infusion dose of RN6G 1 mg/kg of body weight over 120 to 160 minutes on Day 1.
976803|NCT00877032|E1|Reported Event|RN6G 0.3 mg/kg|Single intravenous infusion dose of RN6G 0.3 milligram per kilogram (mg/kg) of body weight over 120 to 160 minutes on Day 1.
976804|NCT00877006|B3|Baseline|Total|Total of all reporting groups
977026|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
977027|NCT00876460|O1|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
976805|NCT00877006|B2|Baseline|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976806|NCT00877006|B1|Baseline|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976807|NCT00877006|P2|Participant Flow|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976808|NCT00877006|P1|Participant Flow|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976809|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976810|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976811|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976812|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976813|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976814|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976815|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"R-CHOP, consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, doxorubicin at 50 mg/m2 by iv over 3-5 minutes on day 1, cyclophosphamide iv at 750 mg/m2 on day 1.~R-CVP consisting of rituximab at 375 mg/m2 iv on day 1, vincristine at 1.4 mg /m2 (up to a maximum dose of 2 mg iv) by iv on day 1, prednisone at 100 mg orally on days 1 to 5 of a 21-day cycle, only 1 of the following doses of cyclophosphamide throughout the study: cyclophosphamide at 750 mg/m2 iv on day 1 or cyclophosphamide at 1000 mg/m2 iv on day 1."
976816|NCT00877006|O1|Outcome|Bendamustine/Rituximab|bendamustine at 90 mg/m2 iv on days 1 and 2 and rituximab at 375 mg/m2 iv infusion on day 1
976817|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976818|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976819|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976820|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976821|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976822|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976823|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976824|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976825|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976826|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976827|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976828|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976829|NCT00877006|O2|Outcome|R-CHOP/R-CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976830|NCT00877006|O1|Outcome|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976831|NCT00877006|E2|Reported Event|R-CHOP/CVP|"Participants received the standard regimen (R-CHOP or R-CVP) for 6 to 8 21-days cycles.~R-CHOP: rituximab 375 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; doxorubicin 50 mg/m^2 IV Day 1; cyclophosphamide 750 mg/m^2 IV Day 1; prednisone 100 mg oral on Days 1 to 5~R-CVP: rituximab 375 mg/m^2 IV on Day 1; cyclophosphamide 750 mg/m^2 IV on Day 1 or cyclophosphamide 1000 mg/m^2 IV on Day 1; vincristine 1.4 mg/m^2 (up to 2 mg/m^2 maximum dose) IV on Day 1; prednisone 100 mg oral on Days 1 to 5"
976832|NCT00877006|E1|Reported Event|Bendamustine and Rituximab (BR)|Participants received the investigational bendamustine and rituximab regimen for 6 to 8 28-day cycles: bendamustine 90 mg/m^2 intravenous (IV) on Days 1 and 2; rituximab 375 mg/m^2 IV on Day 1.
976833|NCT00876928|B3|Baseline|Total|Total of all reporting groups
976834|NCT00876928|B2|Baseline|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
976835|NCT00876928|B1|Baseline|Placebo|Subjects with low vitamin D levels and pre-diabetes
976836|NCT00876928|P2|Participant Flow|Vitamin D|"Subjects with low vitamin D levels and pre-diabetes~Liquid vitamin D3 dissolved in medium chain triglyceride once per week"
976837|NCT00876928|P1|Participant Flow|Placebo|"Subjects with low vitamin D levels and pre-diabetes~Medium chain triglyceride given once per week"
976838|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
976839|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
976840|NCT00876928|O2|Outcome|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
976841|NCT00876928|O1|Outcome|Placebo|Subjects with low vitamin D levels and pre-diabetes
976842|NCT00876928|E2|Reported Event|Vitamin D|Subjects with low vitamin D levels and pre-diabetes
976843|NCT00876928|E1|Reported Event|Placebo|Subjects with low vitamin D levels and pre-diabetes
976844|NCT00876915|B4|Baseline|Total|Total of all reporting groups
976845|NCT00876915|B3|Baseline|Low Risk|Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
976846|NCT00876915|B2|Baseline|High Risk Randomized to No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
976847|NCT00876915|B1|Baseline|High Risk Randomized to Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
976848|NCT00876915|P3|Participant Flow|Low or Medium Risk Group|Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.
976849|NCT00876915|P2|Participant Flow|High Risk No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
976887|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976888|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
981359|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
976850|NCT00876915|P1|Participant Flow|High Risk Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
976851|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
976852|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
976853|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
976854|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
976855|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
976856|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
976857|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
976858|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
976859|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
976860|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
976861|NCT00876915|O2|Outcome|Low Risk|Low Risk ambulatory cancer patients with Khorona scores of 0-2
976862|NCT00876915|O1|Outcome|High Risk|High Risk participants ambulatory cancer patients with Khorona scores 3+
976863|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
976864|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
976865|NCT00876915|O2|Outcome|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
976866|NCT00876915|O1|Outcome|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
976867|NCT00876915|E2|Reported Event|No Therapy|No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
976868|NCT00876915|E1|Reported Event|Dalteparin Injection|"Patients will be assigned at random to receive prophylactic dalteparin injections~dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl)."
976869|NCT00876733|B5|Baseline|Total|Total of all reporting groups
976870|NCT00876733|B4|Baseline|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976871|NCT00876733|B3|Baseline|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976872|NCT00876733|B2|Baseline|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976873|NCT00876733|B1|Baseline|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976874|NCT00876733|P4|Participant Flow|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976875|NCT00876733|P3|Participant Flow|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976876|NCT00876733|P2|Participant Flow|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976877|NCT00876733|P1|Participant Flow|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976878|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976879|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976880|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976881|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976882|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976883|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976884|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976885|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976886|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976890|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976891|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976892|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976893|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976894|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976895|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976896|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976897|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976898|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976899|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976900|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976901|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976902|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976903|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976904|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976905|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976906|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976907|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976908|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976909|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976910|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976911|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976912|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976913|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976914|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976915|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976916|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976917|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976918|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976919|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976920|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976921|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976922|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976923|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976924|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976925|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976926|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976927|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976928|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976929|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976930|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976931|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976932|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976933|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976934|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976935|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976936|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976937|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976938|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976939|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976940|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976941|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976942|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976943|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976944|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976945|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976946|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976947|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976948|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976949|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976950|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976951|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976952|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976953|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976954|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976955|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976956|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976957|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976958|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976959|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976960|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976961|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976962|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976963|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976964|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976965|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976966|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976967|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976968|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976969|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976970|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976971|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976972|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976973|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976974|NCT00876733|O4|Outcome|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976975|NCT00876733|O3|Outcome|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976976|NCT00876733|O2|Outcome|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976977|NCT00876733|O1|Outcome|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976978|NCT00876733|E4|Reported Event|Patients With Baseline Viral Load Not Documented|Patients who could not be assigned to one of the three subgroups and had no documented viral load value.
976979|NCT00876733|E3|Reported Event|Pretreated Patients, Baseline Viral Load > 50 Copies/mL|Patients switching from a virologically ineffective treatment regimen, viral load >50 copies/mL.
976980|NCT00876733|E2|Reported Event|Pretreated Patients, Baseline Viral Load ≤ 50 Copies/mL|Patients switching from a virologically effective treatment regimen (i.e. due to intolerance), with a viral load ≤ 50 copies/mL.
976981|NCT00876733|E1|Reported Event|Treatment-naive Patients|Patients who were not pretreated with HIV therapy.
976982|NCT00876694|B3|Baseline|Total|Total of all reporting groups
976983|NCT00876694|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976984|NCT00876694|B1|Baseline|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976985|NCT00876694|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976986|NCT00876694|P1|Participant Flow|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976987|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976988|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976989|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976990|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976991|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976992|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976993|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976994|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976995|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976996|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976997|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976998|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
976999|NCT00876694|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
977000|NCT00876694|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
977028|NCT00876460|O2|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
977001|NCT00876694|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
977002|NCT00876694|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.
977003|NCT00876460|B9|Baseline|Total|Total of all reporting groups
977004|NCT00876460|B8|Baseline|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977005|NCT00876460|B7|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977006|NCT00876460|B6|Baseline|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977007|NCT00876460|B5|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977008|NCT00876460|B4|Baseline|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977009|NCT00876460|B3|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977010|NCT00876460|B2|Baseline|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977011|NCT00876460|B1|Baseline|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977012|NCT00876460|P8|Participant Flow|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977013|NCT00876460|P7|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977014|NCT00876460|P6|Participant Flow|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977015|NCT00876460|P5|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977016|NCT00876460|P4|Participant Flow|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977017|NCT00876460|P3|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977018|NCT00876460|P2|Participant Flow|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977019|NCT00876460|P1|Participant Flow|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977020|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
977021|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
977022|NCT00876460|O1|Outcome|Docetaxel 50 mg/m2|Patients with Docetaxel 50 mg/m2
977023|NCT00876460|O3|Outcome|Docetaxel 75 mg/m2|Patients with Docetaxel 75 mg/m2
977024|NCT00876460|O2|Outcome|Docetaxel 60 mg/m2|Patients with Docetaxel 60 mg/m2
977030|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
977031|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
977032|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
977033|NCT00876460|O3|Outcome|Nintedanib 200 mg|Patients with Nintedanib 200 mg b.i.d.
977034|NCT00876460|O2|Outcome|Nintedanib 150 mg|Patients with Nintedanib 150 mg b.i.d.
977035|NCT00876460|O1|Outcome|Nintedanib 100 mg|Patients with Nintedanib 100 mg b.i.d.
977036|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977037|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977038|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977039|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977040|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977041|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977042|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977043|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977044|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977045|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977046|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977047|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977048|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977049|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977050|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977051|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977052|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977053|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
982852|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
977054|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977055|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977056|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977057|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977058|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977059|NCT00876460|O5|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977060|NCT00876460|O4|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 200 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977061|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977062|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 150 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977063|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977064|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977065|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977066|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977067|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977068|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977069|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977070|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977071|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977072|NCT00876460|O8|Outcome|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977097|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977098|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977073|NCT00876460|O7|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977074|NCT00876460|O6|Outcome|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977075|NCT00876460|O5|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977076|NCT00876460|O4|Outcome|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977077|NCT00876460|O3|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977078|NCT00876460|O2|Outcome|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977079|NCT00876460|O1|Outcome|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977080|NCT00876460|E8|Reported Event|Nintedanib 200 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977081|NCT00876460|E7|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977082|NCT00876460|E6|Reported Event|Nintedanib 200 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 200 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977083|NCT00876460|E5|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977084|NCT00876460|E4|Reported Event|Nintedanib 150 mg + Docetaxel 75 mg/m2 (BSA <1.5 m^2)|Patients with body surface area <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 75 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977085|NCT00876460|E3|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA >=1.5 m^2)|Patients with body surface area ≥1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977086|NCT00876460|E2|Reported Event|Nintedanib 150 mg + Docetaxel 60 mg/m2 (BSA <1.5 m^2)|Patients with body surface area (BSA) <1.5 m^2 administered a soft gelatin capsule of nintedanib 150 mg, orally, b.i.d. from day 2 in combination with docetaxel 60 mg/m2, injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977087|NCT00876460|E1|Reported Event|Nintedanib 100 mg + Docetaxel 60 mg/m2|Patients administered a soft gelatin capsule of nintedanib 100 mg, orally, twice daily (b.i.d.) from day 2 in combination with docetaxel 60 mg/m2 injection once every three weeks administered via intravenous infusion over one hour. Nintedanib was not taken when docetaxel was administered.
977088|NCT00876447|B3|Baseline|Total|Total of all reporting groups
977089|NCT00876447|B2|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977090|NCT00876447|B1|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977091|NCT00876447|P2|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977092|NCT00876447|P1|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977093|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977094|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977095|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977096|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977212|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|enteral glutamine supplementation
977099|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977100|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977101|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977102|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977103|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977104|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977105|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977106|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977107|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977108|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977109|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977110|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977111|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977112|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977113|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977114|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977115|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977116|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977117|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977118|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977119|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977120|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977121|NCT00876447|O2|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977122|NCT00876447|O1|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks as needed for up to 3 years.
977123|NCT00876447|E26|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 13|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977124|NCT00876447|E25|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 13|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977125|NCT00876447|E24|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 12|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977126|NCT00876447|E23|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 12|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977127|NCT00876447|E22|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 11|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977128|NCT00876447|E21|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 11|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977129|NCT00876447|E20|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 10|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977130|NCT00876447|E19|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 10|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977131|NCT00876447|E18|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 9|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977132|NCT00876447|E17|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 9|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977133|NCT00876447|E16|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 8|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977134|NCT00876447|E15|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 8|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977135|NCT00876447|E14|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 7|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977136|NCT00876447|E13|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 7|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977137|NCT00876447|E12|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 6|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977138|NCT00876447|E11|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 6|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977139|NCT00876447|E10|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 5|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977140|NCT00876447|E9|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 5|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977213|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|parenteral glutamine supplementation
977141|NCT00876447|E8|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 4|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977142|NCT00876447|E7|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 4|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977143|NCT00876447|E6|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 3|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977144|NCT00876447|E5|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 3|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977145|NCT00876447|E4|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 2|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977146|NCT00876447|E3|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 2|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977147|NCT00876447|E2|Reported Event|Botulinum Toxin Type A 200U Treatment Cycle 1|Botulinum toxin Type A 200U injections into the detrusor > 12 weeks as needed for up to 3 years.
977148|NCT00876447|E1|Reported Event|Botulinum Toxin Type A 300U Treatment Cycle 1|Botulinum toxin Type A 300U injections into the detrusor > 12 weeks for up to 3 years.
977149|NCT00876343|B4|Baseline|Total|Total of all reporting groups
977150|NCT00876343|B3|Baseline|Placebo Group|Placebo were administered orally once daily
977151|NCT00876343|B2|Baseline|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
977152|NCT00876343|B1|Baseline|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
977153|NCT00876343|P3|Participant Flow|Placebo Group|Placebo were administered orally once daily
977154|NCT00876343|P2|Participant Flow|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
977155|NCT00876343|P1|Participant Flow|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
977156|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
977157|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
977158|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
977159|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
977160|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
977161|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
977162|NCT00876343|O3|Outcome|Placebo Group|Placebo were administered orally once daily
977163|NCT00876343|O2|Outcome|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
977164|NCT00876343|O1|Outcome|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
977165|NCT00876343|E3|Reported Event|Placebo Group|Placebo were administered orally once daily
977166|NCT00876343|E2|Reported Event|Fixed Dose Group of Aripiprazole|Aripiprazole 3 mg were administered orally once daily
977167|NCT00876343|E1|Reported Event|Variable Dose Group of Aripiprazole|Aripiprazole 3~15 mg were administered orally once daily. During the first week, 3 mg was administered once daily. Thereafter, each week, a dose increase of 3 mg per day was carried out
977168|NCT00876265|B1|Baseline|Overall Study|
977169|NCT00876265|P1|Participant Flow|Overall Study|
977170|NCT00876265|O2|Outcome|Zyplast|Zyplast was injected into the opposite nasolabial fold that Belotero was injected into.
977171|NCT00876265|O1|Outcome|Belotero|Belotero was injected into the left or right nasolabial fold using a randomization schedule.
977172|NCT00876265|E2|Reported Event|Zyplast|
977173|NCT00876265|E1|Reported Event|Belotero|
977174|NCT00875979|B3|Baseline|Total|Total of all reporting groups
977175|NCT00875979|B2|Baseline|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977176|NCT00875979|B1|Baseline|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977177|NCT00875979|P2|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977178|NCT00875979|P1|Participant Flow|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977214|NCT00875797|O2|Outcome|Group - Enteral Glutamine|Group E - group with enterally supplemented glutamine
977215|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
981360|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
977179|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977180|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977181|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977182|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977183|NCT00875979|O2|Outcome|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977184|NCT00875979|O1|Outcome|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977185|NCT00875979|E2|Reported Event|Trastuzumab Emtansine 3.6 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977186|NCT00875979|E1|Reported Event|Trastuzumab Emtansine 3.0 mg/kg + Pertuzumab 420 mg|Patients received trastuzumab emtansine 3.0 mg/kg intravenously (IV) on Day 1 of every 3 week cycle until progressive disease, intolerable toxicity, initiation of another anti-cancer therapy, or patient discontinuation. Patients also received a loading dose of 840 mg of pertuzumab IV on Day 1 of Cycle 1 followed by pertuzumab 420 mg IV on Day 1 of every subsequent 3 week cycle.
977187|NCT00875836|B3|Baseline|Total|Total of all reporting groups
977188|NCT00875836|B2|Baseline|Placebo|Placebo: 30 mg capsules twice daily
977189|NCT00875836|B1|Baseline|Buspirone|Buspirone: 30 mg capsules twice daily
977190|NCT00875836|P2|Participant Flow|Placebo|Placebo: Flexible dose up to 60mg/day
977191|NCT00875836|P1|Participant Flow|Buspirone|Buspirone: Flexible dose up to 60 mg/day
977192|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
977193|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
977194|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
977195|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
977196|NCT00875836|O2|Outcome|Placebo|Placebo: Flexible dose up to 60mg/day
977197|NCT00875836|O1|Outcome|Buspirone|Buspirone: Flexible dose up to 60 mg/day
977198|NCT00875836|E2|Reported Event|Placebo|Placebo: Flexible dose up to 60mg/day
977199|NCT00875836|E1|Reported Event|Buspirone|Buspirone: Flexible dose up to 60 mg/day
977200|NCT00875810|B1|Baseline|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
977201|NCT00875810|P1|Participant Flow|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
977202|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
977203|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
977204|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
977205|NCT00875810|O1|Outcome|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
977206|NCT00875810|E1|Reported Event|Cervical Arthroplasty + Prestige LP|All patients were subjected to a cervical spinal arthroplasty. A complete discectomy was performed and the PRESTIGE® LP Cervical Disc System was inserted to replace the damaged intervertebral disc.
977207|NCT00875797|B3|Baseline|Total|Total of all reporting groups
977208|NCT00875797|B2|Baseline|Enteral Glutamine|enteral glutamine supplementation
977209|NCT00875797|B1|Baseline|Parenteral Glutamine|parenteral glutamine supplementation
977210|NCT00875797|P2|Participant Flow|Group E|Group E - group with enterally supplemented glutamine
977211|NCT00875797|P1|Participant Flow|Group P|Group P - group with parenterally supplemented glutamine
977364|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
977216|NCT00875797|O2|Outcome|Group E - Enteral Glutamine|Group E - group with enterally supplemented glutamine
977217|NCT00875797|O1|Outcome|Group P - Parenteral Glutamine|Group P - group with parenterally supplemented glutamine
977218|NCT00875797|E2|Reported Event|Group E|Group E - group with enterally supplemented glutamine
977219|NCT00875797|E1|Reported Event|Group P|Group P - group with parenterally supplemented glutamine
977220|NCT00875706|B4|Baseline|Total|Total of all reporting groups
977221|NCT00875706|B3|Baseline|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
977222|NCT00875706|B2|Baseline|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
977223|NCT00875706|B1|Baseline|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
977224|NCT00875706|P3|Participant Flow|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
977225|NCT00875706|P2|Participant Flow|Data Collection - Survey|"Survey data collection tools were piloted to assess feasibility of survey administration and development for use in a long-term care setting. These tools were piloted in sites where the educational intervention was administered.~The survey was a modified version of the Care Coordination Survey which was originally validated in a hospital setting (citation below). The survey pertains to work context factors that shape practice, including staffing and resources, communication and IT, participation in decision-making, relationships with supervisors, professional empowerment, and relational coordination. Modifications were made for use of the survey in a VA Community Living Centers.~Weinberg, D., J. Perloff, D. Cooney-Miner, and E. Glaser, Supporting work and workers: Validation of a hospital work organization survey for professional and paraprofessional workers. 2008."
977226|NCT00875706|P1|Participant Flow|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm.~Educational Intervention: The intervention consists of two (2) different types of training, both to be delivered through a train-the-trainer approach. The first of these is coaching-supervision training for nurse managers and other supervisory personnel in the CLC units. The second component is a one-day training for DCWs on communication and managing problem behaviors associated with dementia. These two trainings build on validated training models that have been developed by PHINational, but will be adapted and customized to include VA-developed clinical content on the management of problem behaviors associated with dementia."
977227|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
977228|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
977229|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
977230|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
977231|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
977232|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
977233|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
977234|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
977235|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
977236|NCT00875706|O3|Outcome|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
977237|NCT00875706|O2|Outcome|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
977238|NCT00875706|O1|Outcome|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
977239|NCT00875706|E3|Reported Event|Data Collection - Interview|Interview data collection tools were piloted to assess feasibility of interview administration and development of the interview protocol for future studies. These tools were piloted in sites where the educational intervention was administered.
977240|NCT00875706|E2|Reported Event|Data Collection - Survey|Survey data collection tools were piloted to assess feasibility of survey administration and development of the survey for future studies. These tools were piloted in sites where the educational intervention was administered.
977365|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
977241|NCT00875706|E1|Reported Event|Training Feasibility|"4 sites (8 individuals) received the training intervention to determine the feasibility of the train-the trainer approach.~The educational intervention is included in this arm."
977242|NCT00875615|B1|Baseline|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
977243|NCT00875615|P1|Participant Flow|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
977244|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
977245|NCT00875615|O1|Outcome|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
977246|NCT00875615|E1|Reported Event|Cisplatin or Carboplatin + Sorafenib|"Cisplatin : Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles.~Sorafenib : Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.~Carboplatin : Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles."
977247|NCT00875589|B3|Baseline|Total|Total of all reporting groups
977248|NCT00875589|B2|Baseline|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
977249|NCT00875589|B1|Baseline|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
977250|NCT00875589|P2|Participant Flow|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
977251|NCT00875589|P1|Participant Flow|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
977252|NCT00875589|O2|Outcome|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
977253|NCT00875589|O1|Outcome|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
977254|NCT00875589|E2|Reported Event|MTBI|MTBI Group - subjects with diagnosed Mild Traumatic Brain Injury (MTBI)
977255|NCT00875589|E1|Reported Event|Controls|Control Group - subjects with no Mild Traumatic Brain Injury (MTBI)
977256|NCT00875563|B1|Baseline|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
977257|NCT00875563|P1|Participant Flow|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
977258|NCT00875563|O1|Outcome|Zenith® Fenestrated AAA Endovascular Graft|
977259|NCT00875563|E1|Reported Event|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
977260|NCT00875550|B3|Baseline|Total|Total of all reporting groups
977261|NCT00875550|B2|Baseline|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977262|NCT00875550|B1|Baseline|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977263|NCT00875550|P2|Participant Flow|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977264|NCT00875550|P1|Participant Flow|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977265|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977266|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977267|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977366|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
977268|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977269|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977270|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977271|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977272|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977273|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977274|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores"
977275|NCT00875550|O2|Outcome|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977276|NCT00875550|O1|Outcome|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977277|NCT00875550|E2|Reported Event|Dexmedetomidine High Dose|"Dexmedetomidine: Loading dose 0.5 mcg/kg or 0.6 mcg/kg, Maintenance dose titration range (0.1-0.7 mcg/kg/hr) or (0.2-1.4 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977278|NCT00875550|E1|Reported Event|Dexmedetomidine Low Dose|"Dexmedetomidine: Loading dose 0.2 mcg/kg or 0.3 mcg/kg, Maintenance dose titration range (0.025-0.5 mcg/kg/hr) or (0.05-0.5 mcg/kg/hr)~Midazolam: Rescue medication for sedation according to UMSS scores~Fentanyl: Rescue medication for pain based on UMSS scores~Morphine: Rescue medication for pain based on UMSS scores."
977279|NCT00875485|B3|Baseline|Total|Total of all reporting groups
977280|NCT00875485|B2|Baseline|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977281|NCT00875485|B1|Baseline|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977282|NCT00875485|P2|Participant Flow|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977283|NCT00875485|P1|Participant Flow|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977284|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977285|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977286|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977287|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977288|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977289|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977290|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977291|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977292|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977293|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977294|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977295|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977367|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
977296|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977297|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977298|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977299|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977300|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977301|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977302|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977303|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977304|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977305|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977306|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977307|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977308|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977309|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977310|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977311|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977312|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977313|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977314|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977315|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977316|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977317|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977318|NCT00875485|O2|Outcome|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977319|NCT00875485|O1|Outcome|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977320|NCT00875485|E2|Reported Event|Twinrix Junior Group|Subjects received 3 doses of Twinrix™ Junior (= half dose Twinrix™ Adult) intramuscularly according to a 0, 1, 6 month schedule in the primary study
977321|NCT00875485|E1|Reported Event|Twinrix Adult Group|Subjects received 2 doses of Twinrix™ Adult intramuscularly according to a 0, 6 month schedule in the primary study
977322|NCT00875433|B1|Baseline|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977323|NCT00875433|P1|Participant Flow|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977324|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977325|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977326|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977327|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977328|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977329|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977330|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977331|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977332|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977333|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977334|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977335|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977336|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977337|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977338|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977339|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977340|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977341|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977342|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977343|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977344|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977345|NCT00875433|O1|Outcome|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977346|NCT00875433|E1|Reported Event|All Patients|Patients with tumours known to historically (over)express epidermal growth factor receptor (EGFR)/human epidermal growth factor receptor (HER) 2 with and without brain metastases, and patients with recurrent glioblastoma receiving an oral dose of Afatinib 50 mg once daily (qd)
977347|NCT00875420|B6|Baseline|Total|Total of all reporting groups
977348|NCT00875420|B5|Baseline|Placebo|Oral once a day for 28 days
977349|NCT00875420|B4|Baseline|RAD1901 100 mg|Oral once a day for 28 days
977350|NCT00875420|B3|Baseline|RAD1901 50 mg|Oral once a day for 28 days
977351|NCT00875420|B2|Baseline|RAD1901 25 mg|Oral once a day for 28 days
977352|NCT00875420|B1|Baseline|RAD1901 10 mg|Oral once a day for 28 days
977353|NCT00875420|P5|Participant Flow|Placebo|Oral once a day for 28 days
977354|NCT00875420|P4|Participant Flow|RAD1901 100 mg|Oral once a day for 28 days
977355|NCT00875420|P3|Participant Flow|RAD1901 50 mg|Oral once a day for 28 days
977356|NCT00875420|P2|Participant Flow|RAD1901 25 mg|Oral once a day for 28 days
977357|NCT00875420|P1|Participant Flow|RAD1901 10 mg|Oral once a day for 28 days
977358|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
977359|NCT00875420|O4|Outcome|RAD1901 100 mg|Oral once a day for 28 days
977360|NCT00875420|O3|Outcome|RAD1901 50 mg|Oral once a day for 28 days
977361|NCT00875420|O2|Outcome|RAD1901 25 mg|Oral once a day for 28 days
977362|NCT00875420|O1|Outcome|RAD1901 10 mg|Oral once a day for 28 days
977363|NCT00875420|O5|Outcome|Placebo|Oral once a day for 28 days
977379|NCT00875420|E4|Reported Event|RAD1901 100 mg|Oral once a day for 28 days
977380|NCT00875420|E3|Reported Event|RAD1901 50 mg|Oral once a day for 28 days
977381|NCT00875420|E2|Reported Event|RAD1901 25 mg|Oral once a day for 28 days
977382|NCT00875420|E1|Reported Event|RAD1901 10 mg|Oral once a day for 28 days
977383|NCT00875394|B4|Baseline|Total|Total of all reporting groups
977384|NCT00875394|B3|Baseline|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977385|NCT00875394|B2|Baseline|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977386|NCT00875394|B1|Baseline|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
977387|NCT00875394|P3|Participant Flow|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977388|NCT00875394|P2|Participant Flow|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977389|NCT00875394|P1|Participant Flow|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
977390|NCT00875394|O3|Outcome|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977391|NCT00875394|O2|Outcome|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977392|NCT00875394|O1|Outcome|Sitagliptin + Metformin|Patients administered sitagliptin and metformin.
977393|NCT00875394|E3|Reported Event|Metformin Alone|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977394|NCT00875394|E2|Reported Event|Metformin + Any Non-DPP-4i Oral Antidiabetic Drug|"Patients in the 'standard care' group were to receive continued treatment with metformin and usual care per practice but not to be treated with sitagliptin or another Dipeptidyl peptidase 4 inhibitor (DPP-4i). As prespecified in the protocol, no efficacy was to be assessed for patients receiving standard care."
977395|NCT00875394|E1|Reported Event|Sitagliptin + Metformin|Patients administered sitagliptin and metformin
977396|NCT00875329|B1|Baseline|Group 1|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
977397|NCT00875329|P1|Participant Flow|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder were included. This included all ages, both sexes, and all races and ethnicities. All participants provided responses to demographic information, a TBI Re-screen, and a semi-structured TBI Identification Clinical Interview.
977398|NCT00875329|O1|Outcome|Convenience Sample|A convenience sample of 97VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
977399|NCT00875329|E1|Reported Event|Convenience Sample|A convenience sample of 97 VHA patients who served during the OEF or OIF era, who are targeted in CPRS as requiring the TBI Clinical reminder will be included. This includes all ages, both sexes, and all races and ethnicities.
977400|NCT00875212|B1|Baseline|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
977401|NCT00875212|P1|Participant Flow|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
977402|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a CaGP+Fluoride dentifrice
977403|NCT00875212|O3|Outcome|Fluoride|intrvention of using a 1,500 ppm fluoridated dentifrice
977404|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a CaGP dentifrice
977405|NCT00875212|O1|Outcome|Control|use of a placebo dentifrice (no fluoride and no CaGP). The volunteers were asked to use the placebo dentifrices for more one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
977406|NCT00875212|O4|Outcome|Calcium Glycerophosphate and Fluoride|intervention of using a dentifrice containing fluoride and calcium glycerophosphate
981361|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
977407|NCT00875212|O3|Outcome|Fluoride|intervention of using a dentifrice with 1,500 ppm of fluoride
977408|NCT00875212|O2|Outcome|Calcium Glycerophosphate|intervention of using a dentifrice containing only calcium glycerophosphate (CaGP)
977409|NCT00875212|O1|Outcome|Control|intervention of using a dentifrice of no active ingredient. The volunteers were asked to use the placebo dentifrices for one week. Throughout the study, the volunteers were instructed to brush their teeth normally up until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
977410|NCT00875212|E1|Reported Event|Toothbrushing|The study was based on the use of dentifrices for daily oral hygiene in a crossover design. The volunteers were asked to use the placebo and test dentifrices for one week. During the study, the volunteers were instructed to brush their teeth normally until 3 days before the measurements. During these 3 days, they were instructed to brush only the occlusal surfaces of their teeth until 12 hours before the pH measurements, when they should stop brushing altogether for dental plaque pH evaluation.
977411|NCT00875017|B7|Baseline|Total|Total of all reporting groups
977412|NCT00875017|B6|Baseline|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977413|NCT00875017|B5|Baseline|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
977414|NCT00875017|B4|Baseline|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977415|NCT00875017|B3|Baseline|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977416|NCT00875017|B2|Baseline|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977417|NCT00875017|B1|Baseline|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
977418|NCT00875017|P6|Participant Flow|Sequence 6|Meal only in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977419|NCT00875017|P5|Participant Flow|Sequence 5|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
977420|NCT00875017|P4|Participant Flow|Sequence 4|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977421|NCT00875017|P3|Participant Flow|Sequence 3|Meal only in first intervention period, washout, Lanthanum carbonate (1000 mg) + meal in second intervention period, washout, Sevelamer carbonate (2400 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977422|NCT00875017|P2|Participant Flow|Sequence 2|Sevelamer carbonate (2400 mg) + meal in first intervention period, washout, Meal only in second intervention period, washout, Lanthanum carbonate (1000 mg) + meal in third intervention period, washout, Fasting in fourth intervention period
977423|NCT00875017|P1|Participant Flow|Sequence 1|Lanthanum carbonate (1000 mg) + meal in first intervention period, washout, Sevelamer carbonate (2400 mg) + meal in second intervention period, washout, Meal only in third intervention period, washout, Fasting in fourth intervention period
977424|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of calcium is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of calcium is measured.
977425|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
977426|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of calcium is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of calcium is measured.
977427|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
977428|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
977429|NCT00875017|O3|Outcome|Meal Only|A meal containing a known amount of phosphorous is ingested. No phosphorous binder is administered. 10 hours post-meal, rectal effluent is collected and the amount of phosphorous is measured.
977430|NCT00875017|O2|Outcome|Sevelamer Carbonate|A meal containing a known amount of phosphorous is ingested along wuith oral administration of the phosphorous binder, sevelamer carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
977431|NCT00875017|O1|Outcome|Lanthanum Carbonate|A meal containing a known amount of phosphorous is ingested along with oral administration of the phosphorous binder, lanthanum carbonate. 10 hours post-dose, rectal effluent is collected and the amount of phosphorous is measured.
977432|NCT00875017|E4|Reported Event|Fasting|
977433|NCT00875017|E3|Reported Event|Meal Only|
977434|NCT00875017|E2|Reported Event|Sevelamer Carbonate|
977435|NCT00875017|E1|Reported Event|Lanthanum Carbonate|
981362|NCT00862082|O1|Outcome|PR104|
977437|NCT00874939|P1|Participant Flow|All Participants|All enrolled participants
977438|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977439|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977440|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
977441|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977442|NCT00874939|O2|Outcome|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977443|NCT00874939|O1|Outcome|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977444|NCT00874939|O2|Outcome|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
977445|NCT00874939|O1|Outcome|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977446|NCT00874939|E4|Reported Event|Placebo|Participants treated with Placebo for MK-0249 tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977447|NCT00874939|E3|Reported Event|MK-0249 25 mg|Participants treated with MK-0249 25 mg tablets and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977448|NCT00874939|E2|Reported Event|Donepezil 5 mg|Participants treated with Placebo for MK-0249 tablets, and Donepezil 5 mg capsule, by single oral dose during each crossover period.
977449|NCT00874939|E1|Reported Event|MK-0249 7.5 mg|Participants treated with MK-0249 7.5 mg tablets + a single MK-0249 placebo tablet and Placebo for Donepezil capsule, by single oral dose during each crossover period.
977450|NCT00874887|B3|Baseline|Total|Total of all reporting groups
977451|NCT00874887|B2|Baseline|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977452|NCT00874887|B1|Baseline|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977453|NCT00874887|P2|Participant Flow|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977454|NCT00874887|P1|Participant Flow|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977455|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977456|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977457|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977458|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977459|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977460|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977461|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977462|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977463|NCT00874887|O2|Outcome|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977464|NCT00874887|O1|Outcome|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977465|NCT00874887|E2|Reported Event|Zymar®|Gatifloxacin 0.3% ophthalmic solution
977466|NCT00874887|E1|Reported Event|Vigamox®|Moxifloxacin 0.5% HCL ophthalmic solution
977467|NCT00874848|B3|Baseline|Total|Total of all reporting groups
977468|NCT00874848|B2|Baseline|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977469|NCT00874848|B1|Baseline|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977470|NCT00874848|P2|Participant Flow|Control Arm|"Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
977471|NCT00874848|P1|Participant Flow|Imprime PGG Arm|"Imprime PGG® infusion:~4 mg/kg i.v. over 2 to 4 hrs on Days 1, 8 and 15 of each 3-week treatment cycle;~Cetuximab infusion:~initial loading dose of 400 mg/m2 over 120 min and subsequent doses at 250 mg/m2 over 60 min, on Days 1, 8 and 15 of each 3-week treatment cycle;~Paclitaxel infusion:~200 mg/m2 i.v. over 3 hr on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles~Carboplatin infusion:~dose equal to an AUC of 6 mg/mL · min based on the Calvert formula; i.v. over 30 min on Day 2 of each 3-week treatment cycle for the first 4 to 6 treatment cycles.~Following the completion of at least the initial 4 treatment cycles (but no more than 6), participants experiencing stable disease, or a complete or partial response, were eligible to discontinue the chemotherapy treatment and continue dosing of Imprime PGG and cetuximab for a maximum of 18 treatment cycles without a treatment extension being authorized by the Sponsor."
977472|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977473|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977474|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977475|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977476|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977477|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977478|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977479|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977480|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977481|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977482|NCT00874848|O2|Outcome|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977483|NCT00874848|O1|Outcome|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977484|NCT00874848|E2|Reported Event|Control Arm|Cetuximab + Paclitaxel/Carboplatin
977485|NCT00874848|E1|Reported Event|Imprime PGG Arm|Imprime PGG Injection + Cetuximab + Paclitaxel/Carboplatin
977486|NCT00874822|B1|Baseline|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
977487|NCT00874822|P1|Participant Flow|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
977488|NCT00874822|O1|Outcome|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
977489|NCT00874822|E1|Reported Event|Berlin|Patients diagnosed with obstructive sleep apnea by polysomnography after being screened with the Berlin questionnaire.
977490|NCT00874770|B5|Baseline|Total|Total of all reporting groups
977491|NCT00874770|B4|Baseline|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977492|NCT00874770|B3|Baseline|Daclatasvir 60-mg+pegIFNα-2a+Ribavirin|Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977493|NCT00874770|B2|Baseline|Daclatasvir 10-mg+pegIFNα-2a+Ribavirin|Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977494|NCT00874770|B1|Baseline|Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977495|NCT00874770|P4|Participant Flow|Placebo+pegIFNα-2a+Ribavirin|Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977496|NCT00874770|P3|Participant Flow|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977497|NCT00874770|P2|Participant Flow|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977498|NCT00874770|P1|Participant Flow|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977499|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets once daily for 48 weeks coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977500|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977501|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977502|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977503|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).48 weeks.
977504|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977505|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977506|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Riibavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977507|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977508|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977509|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977510|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977511|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weekswith pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977512|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977513|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10-mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977514|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977515|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977516|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977517|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977518|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977519|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977520|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977521|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977522|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Rribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977523|NCT00874770|O4|Outcome|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977641|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977524|NCT00874770|O3|Outcome|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977525|NCT00874770|O2|Outcome|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977526|NCT00874770|O1|Outcome|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977527|NCT00874770|E4|Reported Event|Placebo + pegIFNα-2a + Ribavirin|Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977528|NCT00874770|E3|Reported Event|Daclatasvir 60 mg + pegIFNα-2a + Ribavirin|Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977529|NCT00874770|E2|Reported Event|Daclatasvir 10 mg + pegIFNα-2a + Ribavirin|Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977530|NCT00874770|E1|Reported Event|Daclatasvir 3 mg + pegIFNα-2a + Ribavirin|Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants <75 kg or 600 mg tablets for participants >75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
977531|NCT00874549|B5|Baseline|Total|Total of all reporting groups
977532|NCT00874549|B4|Baseline|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977533|NCT00874549|B3|Baseline|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977534|NCT00874549|B2|Baseline|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977535|NCT00874549|B1|Baseline|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977536|NCT00874549|P4|Participant Flow|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977537|NCT00874549|P3|Participant Flow|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977538|NCT00874549|P2|Participant Flow|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977539|NCT00874549|P1|Participant Flow|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977540|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977541|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977542|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977543|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977544|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977545|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977546|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977547|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
978038|NCT00873015|O1|Outcome|64 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 64 nmol/min/kg
977548|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977549|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977550|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977551|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977552|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977553|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977554|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977555|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977556|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977557|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977558|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977559|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977560|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977561|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977562|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977563|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977564|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977565|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977566|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977567|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977568|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977569|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977570|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977571|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977572|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977573|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977574|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977575|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977576|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977577|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977578|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977579|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977580|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977581|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977582|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977583|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977584|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977585|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977586|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977587|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977588|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977589|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977590|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977591|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977592|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977593|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977594|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977595|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977596|NCT00874549|O4|Outcome|Group 4: Menactra® Day 0 and 28|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 28.
977597|NCT00874549|O3|Outcome|Group 3: Menactra® Day 0 and 14|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menactra® intramuscularly on Day 0 and again on Day 14.
977598|NCT00874549|O2|Outcome|Group 2: Menactra® Day 0 x 2|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received 2 single-dose injections of Menactra® intramuscularly on Day 0.
977599|NCT00874549|O1|Outcome|Group 1: Menomune® Day 0|Participants with no prior meningococcal vaccine exposure who had received no diphtheria-containing vaccine in the prior 2 years received a single dose of Menomune® subcutaneously on Day 0.
977600|NCT00874549|E4|Reported Event|Menactra® Day 0 and Day 28|
977601|NCT00874549|E3|Reported Event|Menactra® Day 0 and Day 14|
977602|NCT00874549|E2|Reported Event|Menactra® Day 0 x 2|
977603|NCT00874549|E1|Reported Event|Menomune® Day 0|
977604|NCT00874510|B3|Baseline|Total|Total of all reporting groups
977642|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
981363|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
977605|NCT00874510|B2|Baseline|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
977606|NCT00874510|B1|Baseline|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
977607|NCT00874510|P2|Participant Flow|Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
977608|NCT00874510|P1|Participant Flow|Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
977609|NCT00874510|O2|Outcome|Arm 2 - Mandatory Nap|"In Year 1 interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am and were asked to nap during this time~For Year 2, the mandatory sign out of cell phones and cross-coverage responsibilities was split between two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am and were asked to nap during this time"
977610|NCT00874510|O1|Outcome|Arm 1 - Standard Schedule for Years 1 and Year 2|interns work standard schedule, being on duty for 30 continuous hours
977611|NCT00874510|E2|Reported Event|Arm 2 - Mandatory Naps|"interns on overnight extended duty shifts have mandatory sign out of cell phones and cross-coverage responsibilities for 5 hours roughly between 12 and 5 am. For Year 2, this will be two 3 hour shifts, the first between 12am-3am and the 2nd between 3am-6am.~Mandatory Naps: As above, interns on extended duty overnight call shifts will be required to transfer cell phones and cross-coverage responsibilities to night float residents for a 5 hour period each night they are on call. For Year 2, interns will nap in shifts, instead of concurrently, with the first nap shift between 12am-3am and the second shift between 3am-6am"
977612|NCT00874510|E1|Reported Event|Arm 1 - Standard Schedule|interns work standard schedule, being on duty for 30 continuous hours
977613|NCT00874497|B3|Baseline|Total|Total of all reporting groups
977614|NCT00874497|B2|Baseline|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977615|NCT00874497|B1|Baseline|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977616|NCT00874497|P2|Participant Flow|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977617|NCT00874497|P1|Participant Flow|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977618|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977619|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977620|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977621|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977622|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977623|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977624|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977625|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977626|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977627|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977628|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977629|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977630|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977631|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977632|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977633|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977634|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977635|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977636|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977637|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977638|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977639|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977640|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977643|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977644|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977645|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977646|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977647|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977648|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977649|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977650|NCT00874497|O2|Outcome|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977651|NCT00874497|O1|Outcome|Tetomilast 50 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977652|NCT00874497|E2|Reported Event|Placebo|Participants were administered matching placebo for 104 weeks (2 years)
977653|NCT00874497|E1|Reported Event|Tetomilast 25 mg|Participants were administered oral tetomilast 25 milligram (mg) once daily for 2 weeks followed by 50 mg once daily for 102 weeks.
977654|NCT00874276|B3|Baseline|Total|Total of all reporting groups
977655|NCT00874276|B2|Baseline|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
977656|NCT00874276|B1|Baseline|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
977657|NCT00874276|P2|Participant Flow|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
977658|NCT00874276|P1|Participant Flow|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
977659|NCT00874276|O2|Outcome|At Least One EGT Allele|At least one EGT allele
977660|NCT00874276|O1|Outcome|No EGT Allele|No EGT allele
977661|NCT00874276|O2|Outcome|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
977662|NCT00874276|O1|Outcome|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|"Both dichloroacetate 2.5ug and 25mg per kg per day and is administered for five days. (Biologic randomization)~Dichloroacetate 2.5.ug/kg (Environmental) and 25mg/kg (clinical) are administered daily for 5 days in all subjects. Subjects are admitted to the clinical research center for 6 nights. The first day subjects are administer 2.5ug/kg/day. Frequent blood samples are collected over a 24 hour period. On days 2, 3, and 4 the subjects receive a dose of DCA each day. On day 5 they receive a dose of DCA and pharmacokinetics are done for 24 hours then subjects are discharged."
977663|NCT00874276|E2|Reported Event|1+ EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
977664|NCT00874276|E1|Reported Event|Lack Any EGT Allele on GSTz1/MAAI Region of Chromosome 14q24.3|This study is a biological randomization for dichloroacetate pharmacodynamics for those with at least one EGT vs. without any EGT haplotype of the GSTZ1/MAAI gene which is located on chromosome 14q24.3.
977665|NCT00874250|B1|Baseline|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
977666|NCT00874250|P1|Participant Flow|GORE CTAG Device|The primary endpoint of this study is freedom from a Major Device Event (MDE) through 1 month post-treatment in subjects treated with the GORE® Conformable TAG® Thoracic Endoprosthesis.
977667|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
977668|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
977669|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
977670|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
977671|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
977672|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
977673|NCT00874250|O1|Outcome|CTAG Device Aneurysym Subjects|
977674|NCT00874250|E1|Reported Event|CTAG Device Aneurysym Subjects|
977675|NCT00874120|B3|Baseline|Total|Total of all reporting groups
977676|NCT00874120|B2|Baseline|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
981364|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
977677|NCT00874120|B1|Baseline|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
977678|NCT00874120|P2|Participant Flow|Placebo Followed by Phenylephrine|Placebo twice daily for 7 days followed by a 6- to 8-day washout period followed by Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
977679|NCT00874120|P1|Participant Flow|Phenylephrine Followed by Placebo|Phenylephrine hydrochloride (HCl) Extended Release tablets 30 mg twice daily for 7 days followed by a 6- to 8-day washout period followed by placebo twice daily for 7 days
977680|NCT00874120|O2|Outcome|Placebo|Placebo twice daily for 7 days
977681|NCT00874120|O1|Outcome|Phenylephrine|Phenylephrine HCl Extended Release tablets 30 mg twice daily for 7 days
977682|NCT00874120|E2|Reported Event|Placebo|Placebo twice daily for 7 days
977683|NCT00874120|E1|Reported Event|Phenylephrine|Phenylephrine HCL Extended Release tablets 30 mg twice daily for 7 days
977684|NCT00874094|B1|Baseline|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
977685|NCT00874094|P1|Participant Flow|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
977686|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
977687|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
977688|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
977689|NCT00874094|O1|Outcome|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
977690|NCT00874094|E1|Reported Event|Treatment With Platelet Rich Fibrin Matrix|Both nasolabial folds treated with platelet rich fibrin matrix
977691|NCT00874029|B1|Baseline|Halt Medical Acessa Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids had the Acessa Procedure using the Halt Medical Proprietary Acessa System. The Acessa System delivers monopolar radiofrequency energy to tissue through a disposable electrosurgical radiofrequency (RF) Handpiece. The Generator provides sinusoidally-varying voltage at 460 kilohertz (kHz) to drive a current through the tissue to be ablated. The current delivered through the Handpiece causes controlled, local heating, resulting in targeted tissue destruction. The heat produced then disperses by conduction. During these controlled ablations, the Generator produces an alternating current which flows between the Handpiece and the dispersive electrode pads, through the body of the patient. These components, coupled with the visualization capabilities of laparoscopic ultrasound, enable the surgeon to accurately identify the patient’s uterine fibroids and treat all of her fibroids, and just the fibroids.
977692|NCT00874029|P1|Participant Flow|Halt Procedure|In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
977693|NCT00874029|O2|Outcome|How Effective Was This Treatment in Eliminating Symptoms|Patients were asked to respond in their opinion, how effective was this treatment in eliminating their symptoms.
977694|NCT00874029|O1|Outcome|Overall, Satisfaction With Uterine Fibroid Treatment|Patients were asked, overall, how satisfied with their uterine fibroid treatment.
977695|NCT00874029|O1|Outcome|Full Analysis Set - Month 12 Health Status Change|All subjects who completed the Health State Score Questionnaire (EQ-5D) at both baseline and at 12 months post treatment.
977696|NCT00874029|O2|Outcome|Full Analysis Set - Health Related Quality of Life (HRQL)|All treated subjects who met all inclusion and exclusion Criteria and who completed the HRQL questionnaire at both baseline and 12 months.
977697|NCT00874029|O1|Outcome|Full Analysis Set - Symptom Severity|All treated subjects who met all inclusion and exclusion criteria and who completed the Symptom Severity Questionnaire at Baseline and 12 months.
977698|NCT00874029|O2|Outcome|Change in Fibroid Volume|Fibroid volume assessment 12 months post treatment via contrast enhanced MRI
977699|NCT00874029|O1|Outcome|Change in Uterine Volume|Uterine volume assessment 12 months post treatment via contrast enhanced MRI
977700|NCT00874029|O1|Outcome|Surgical Reintervention 12 Months Post Treatment|The Per Protocol Set was the primary analysis set for surgical reintervention.
977701|NCT00874029|O2|Outcome|Procedural|Procedure-related events are those that the investigator considered to be definitely, probably, or possibly related to the procedure, including those related to abdominal entry and anesthesia.
977702|NCT00874029|O1|Outcome|Device Related Adverse Events|Device-related events are those that the investigator considered to be definitely, probably, or possibly related to the device.
977703|NCT00874029|O1|Outcome|Change of Menstrual Blood Flow(MBF) @ 12 Months Post Treatment|"Of the 137 subjects enrolled and treated under this protocol, 124 (90.5%) were considered evaluable in terms of their 1) ability to provide a menstrual blood loss assessment, 2) lack of concomitant disease that affects the menstrual cycle, 3) baseline menstrual blood loss was within protocol inclusion limits."
977704|NCT00874029|E1|Reported Event|Safety Set|The Safety Set consisted of all subjects treated in the study.
977705|NCT00873912|B3|Baseline|Total|Total of all reporting groups
977706|NCT00873912|B2|Baseline|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977707|NCT00873912|B1|Baseline|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977708|NCT00873912|P2|Participant Flow|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977709|NCT00873912|P1|Participant Flow|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977710|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977711|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977712|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977713|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977714|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977715|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977716|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977717|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977718|NCT00873912|O2|Outcome|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977719|NCT00873912|O1|Outcome|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977720|NCT00873912|E2|Reported Event|Placebo|Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 1.
977721|NCT00873912|E1|Reported Event|Monovalent Influenza Virus Vaccine|Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 fluorescent focus units (FFU) of influenza virus type B/Brisbane/60/2008 (Victoria lineage). A single dose of investigational product was administered on Day 1.
977722|NCT00873873|B5|Baseline|Total|Total of all reporting groups
977723|NCT00873873|B4|Baseline|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
977724|NCT00873873|B3|Baseline|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
977725|NCT00873873|B2|Baseline|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
977726|NCT00873873|B1|Baseline|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
977727|NCT00873873|P4|Participant Flow|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
977728|NCT00873873|P3|Participant Flow|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
977729|NCT00873873|P2|Participant Flow|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
977730|NCT00873873|P1|Participant Flow|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
977731|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
977732|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
977733|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
977734|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
977735|NCT00873873|O4|Outcome|Persistent Normal|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
977840|NCT00873730|P1|Participant Flow|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977736|NCT00873873|O3|Outcome|Late Normal|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
977737|NCT00873873|O2|Outcome|Late Obstruction|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
977738|NCT00873873|O1|Outcome|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
977739|NCT00873873|E4|Reported Event|Persistent Normal in Pulmonary Physiology|This groups has normal pulmonary function at the time of entry into the CAMP study and normal pulmonary function 9 years later.
977740|NCT00873873|E3|Reported Event|Late Normal in Pulmonary Physiology|This group represents those that has evidence of obstruction, as defined by FEV1/FVC criteria, from baseline at entry into the NHLBI CAMP study and then has normal pulmonary function at end of the CAMP.
977741|NCT00873873|E2|Reported Event|Late Obstruction in Pulmonary Physiology|This group represents those that had normal pulmonary function from baseline at entry into the NHLBI CAMP study and then has evidence of obstruction, as defined by FEV1/FVC criteria, at end of the CAMP Continuation study, 9 years later.
977742|NCT00873873|E1|Reported Event|Persistent Obstruction|This group represents those that have persistent obstruction from baseline at entry into the NHLBI CAMP study until end of the CAMP Continuation study, 9 years later.
977743|NCT00873860|B5|Baseline|Total|Total of all reporting groups
977744|NCT00873860|B4|Baseline|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977745|NCT00873860|B3|Baseline|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977746|NCT00873860|B2|Baseline|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977747|NCT00873860|B1|Baseline|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977748|NCT00873860|P4|Participant Flow|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977749|NCT00873860|P3|Participant Flow|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977750|NCT00873860|P2|Participant Flow|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977751|NCT00873860|P1|Participant Flow|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977752|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977753|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977754|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977755|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977756|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977757|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977758|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977759|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977760|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977761|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977762|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977763|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977764|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977765|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977766|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977767|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977768|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977769|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977770|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977771|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977772|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977773|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977774|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977775|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977776|NCT00873860|O3|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977777|NCT00873860|O2|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
978830|NCT00870363|B4|Baseline|HIV Negative Controls Not on ART|HIV-negative
977778|NCT00873860|O1|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977779|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977780|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977781|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977782|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977783|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977784|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977785|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977786|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977787|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977788|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977789|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977790|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977791|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977792|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977793|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977794|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977795|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977796|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977797|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977798|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977799|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977800|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977801|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977802|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977803|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977804|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977805|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977806|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977807|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977808|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977809|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977810|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977811|NCT00873860|O4|Outcome|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977812|NCT00873860|O3|Outcome|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977813|NCT00873860|O2|Outcome|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977814|NCT00873860|O1|Outcome|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977815|NCT00873860|E4|Reported Event|CAT-354 600 mg|CAT-354 600 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977816|NCT00873860|E3|Reported Event|CAT-354 300 mg|CAT-354 300 mg subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977817|NCT00873860|E2|Reported Event|CAT-354 150 mg|CAT-354 150 milligram (mg) subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977818|NCT00873860|E1|Reported Event|Placebo|Placebo matched to CAT-354 subcutaneous injection once every 2 weeks on Day 1, 15, 29, 43, 57, 71, and 85.
977819|NCT00873821|B3|Baseline|Total|Total of all reporting groups
977820|NCT00873821|B2|Baseline|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
977821|NCT00873821|B1|Baseline|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
977822|NCT00873821|P2|Participant Flow|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
977823|NCT00873821|P1|Participant Flow|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
977824|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
977825|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
977826|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
977827|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
977828|NCT00873821|O2|Outcome|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
977829|NCT00873821|O1|Outcome|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
977830|NCT00873821|E2|Reported Event|Placebo|Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.
977831|NCT00873821|E1|Reported Event|MK-0941|Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.
977832|NCT00873782|B1|Baseline|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
977833|NCT00873782|P1|Participant Flow|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
977834|NCT00873782|O1|Outcome|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
977835|NCT00873782|E1|Reported Event|High Pressure Transvenous Limb Perfusion|Participants will undergo retrograde high pressure transvenous limb perfusion of an arm or a leg with normal saline through an 18g or 20g peripheral catheter with a tourniquet on the upper part of the limb: The volume of saline as % of perfused limb volume was escalated beginning at 5%. Safety was determined by Doppler ultrasound to assess venous and arterial damage electrodiagnostic neurographic testing quantitative muscle testing strength assessments, the Action Research Arm Test (ARAT), basic metabolic panel (Na+, K+, Cl-, CO2, BUN, and creatinine), serum creatine kinase [CK], plasma and urine myoglobin. Some subjects underwent MRI to assess whether saline went subcutaneously or intramuscularly.
977836|NCT00873730|B3|Baseline|Total|Total of all reporting groups
977837|NCT00873730|B2|Baseline|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977838|NCT00873730|B1|Baseline|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977839|NCT00873730|P2|Participant Flow|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977841|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977842|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977843|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977844|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977845|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977846|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977847|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977848|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977849|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977850|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977851|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977852|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977853|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977854|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977855|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977856|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977857|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977858|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977859|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977860|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977861|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977862|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977863|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977864|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977865|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977866|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977867|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977868|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977869|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977870|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977871|NCT00873730|O2|Outcome|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977872|NCT00873730|O1|Outcome|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977873|NCT00873730|E2|Reported Event|Etanercept QW|etanercept 50 mg once a week (QW) and placebo once a week for 12 weeks
977874|NCT00873730|E1|Reported Event|Etanercept BIW|etanercept 50 mg twice a week (BIW) for 12 weeks
977875|NCT00873457|B1|Baseline|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
977876|NCT00873457|P1|Participant Flow|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
977877|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
977878|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
977879|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
977880|NCT00873457|O1|Outcome|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
977881|NCT00873457|E1|Reported Event|Perifosine|Perifosine 50 mg twice a day for a total of six 28-day cycles.
977882|NCT00873327|B1|Baseline|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
977883|NCT00873327|P1|Participant Flow|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days postnatal age (PNA) 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation (GA) at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
977884|NCT00873327|O1|Outcome|PK Analysis Cohort - Piperacillin Plasma Clearance|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
977885|NCT00873327|E1|Reported Event|GA of 32 Wks, PNA of 14 Days|"Open label -- 6 interval doses~piperacillin-tazobactam : 6 doses intravenously at the following doses:~Infants <32 weeks gestation at birth < 14 days PNA 100 mg/kg Q8 ≥ 14 weeks PNA 100 mg/kg Q6~Infants ≥32 weeks gestation at birth < 14 days PNA 100 mg/kg Q6~≥ 14 days PNA 100 mg/kg Q6"
977886|NCT00873119|B3|Baseline|Total|Total of all reporting groups
977887|NCT00873119|B2|Baseline|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977888|NCT00873119|B1|Baseline|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
978030|NCT00873015|B2|Baseline|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
977889|NCT00873119|P2|Participant Flow|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977890|NCT00873119|P1|Participant Flow|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977891|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977892|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977893|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977894|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977895|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977896|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977897|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977898|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977899|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977900|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977901|NCT00873119|O2|Outcome|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977902|NCT00873119|O1|Outcome|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977903|NCT00873119|E2|Reported Event|Arm B - CaP|Group B: paclitaxel (175 mg/m²) administered as an IV infusion directly followed by carboplatin (AUC 6) administered as a 30-60 minute IV infusion on cycle day 1 of a 3-weekly cycle.
977904|NCT00873119|E1|Reported Event|Arm A - BelCaP|Group A: belinostat (1000 mg/m²) administered as a 30 minute IV infusion once daily on days 1, 2 and 3, with at least 18 hours between infusions, followed by belinostat (2000 mg) administered orally once daily on days 4 and 5, every 3-weeks, in combination with paclitaxel (175 mg/m²) administered as an IV infusion following the infusion of belinostat on cycle day 3, and carboplatin (AUC 6) administered as a 30-60 minute IV infusion directly after the paclitaxel administration on cycle day 3.
977905|NCT00873093|B6|Baseline|Total|Total of all reporting groups
977906|NCT00873093|B5|Baseline|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977907|NCT00873093|B4|Baseline|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
978031|NCT00873015|B1|Baseline|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion 32 nmol/min/kg
978032|NCT00873015|P4|Participant Flow|Nitrite 64 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 64 nmol/min/kg
977908|NCT00873093|B3|Baseline|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977909|NCT00873093|B2|Baseline|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977910|NCT00873093|B1|Baseline|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977911|NCT00873093|P5|Participant Flow|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977912|NCT00873093|P4|Participant Flow|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977913|NCT00873093|P3|Participant Flow|Pre-B ALL Relapse<18 Mths From Diagnosis (Chemo) Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977914|NCT00873093|P2|Participant Flow|Pre-B ALL Relapse 18-36 Mths From Diagnosis (Chemo) Age<=21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977915|NCT00873093|P1|Participant Flow|Pre-B ALL Relapse<36 Mths From Diagnosis (Chemo) Age>21 yr|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977916|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977917|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977918|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977946|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977947|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977919|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977920|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977921|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977922|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977923|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977924|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977925|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977948|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
978033|NCT00873015|P3|Participant Flow|Nitrite 48 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 48 nmol/min/kg
978034|NCT00873015|P2|Participant Flow|Nitrite 32 Nmol/Min/kg|14 day continuous infusion of sodium nitrite 32 nmol/min/kg
977926|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977927|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977928|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977929|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977930|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977931|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977932|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~methotrexate: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977949|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
978035|NCT00873015|P1|Participant Flow|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
978036|NCT00873015|O3|Outcome|32 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 32 nmol/min/kg
977933|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977934|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 & 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 & 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977935|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|"Re-Induction Block 1 patients receive vincristine sulfate, Prednisone, pegaspargase, Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and MTX. Re-Induction Block 3 patients receive Cytarabine.~L-asparaginase: Given IM 6000 IU/m2/dose Days 2 and 9~doxorubicin hydrochloride: Given IV 60 mg/m2/dose on Day 1~therapeutic hydrocortisone: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 8,15, 22 & 29 Block 2: Days 1 & 22~vincristine sulfate: Given IV 1.5 mg/m2 (max 2 mg) on Days 1, 8, 15 and 22~cytarabine: Given IT or IV 3,000 mg/m2/dose on Days 1, 2, 8 & 9~prednisone: Given PO or IV 40 mg/m2/day on Days 1-28~bortezomib: Given IV 1.3 mg/m2/dose Block 1: Days 1, 4, 8 & 11 Block 2: Days 1, 4 & 8~pegaspargase: Given IM or IV (over 2 hours) 2500 IU/m2/dose on days 2, 8,15 & 22~MTX: Given IT (8mg - 15mg) Age-based dosing Block 1: Days 15 & 29 Block 2: Days 1 & 22~etopo"
977936|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977937|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977938|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977939|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977940|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977941|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977942|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977943|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977944|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977945|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977950|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977951|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
977952|NCT00873093|O1|Outcome|Overall|All enrolled eligible patients.
977953|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977954|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977955|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977956|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977957|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977958|NCT00873093|O5|Outcome|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977959|NCT00873093|O4|Outcome|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977960|NCT00873093|O3|Outcome|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977961|NCT00873093|O2|Outcome|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977962|NCT00873093|O1|Outcome|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977963|NCT00873093|E5|Reported Event|T-cell Lymphoblastic Lymphoma (LL) (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977964|NCT00873093|E4|Reported Event|T-cell ALL (Chemotherapy)|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977965|NCT00873093|E3|Reported Event|Pre-B ALL Relapse <18 Mths From Dx (Chemotherapy) Age <=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977966|NCT00873093|E2|Reported Event|Pre-B ALL Relapse 18-36 Mths From Dx (Chemotherapy)Age<=21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977985|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977967|NCT00873093|E1|Reported Event|Pre-B ALL Relapse < 36 Mths From Dx (Chemotherapy) Age >21 Yrs|Re-Induction Block 1 patients receive liposomal vincristine sulfate , Prednisone, pegaspargase and Doxorubicin hydrochloride. Re-Induction Block 2 patients receive Cyclophosphamide, Etoposide phosphate, and Methotrexate. Re-Induction Block 3 patients receive Cytarabine and L-Asparaginase. Patients receive Bortezomib on days 1, 4, 8 & 11 of Block 1 and days 1, 4, & 8 of Block 2.
977968|NCT00873041|B4|Baseline|Total|Total of all reporting groups
977969|NCT00873041|B3|Baseline|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977970|NCT00873041|B2|Baseline|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977971|NCT00873041|B1|Baseline|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977972|NCT00873041|P3|Participant Flow|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977973|NCT00873041|P2|Participant Flow|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977974|NCT00873041|P1|Participant Flow|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977975|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977976|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977977|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977978|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977979|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977980|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977981|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977982|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977983|NCT00873041|O1|Outcome|Deferasirox|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
977984|NCT00873041|O2|Outcome|Placebo/Deferasirox|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
981365|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
977986|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977987|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977988|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977989|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977990|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977991|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977992|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977993|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977994|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977995|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977996|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977997|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977998|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
977999|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978000|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978001|NCT00873041|O1|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978002|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978003|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978004|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978005|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978006|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978037|NCT00873015|O2|Outcome|48 Nmol/Min/kg|Sodium nitrite : 14 day continuous infusion of 48 nmol/min/kg
978007|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978008|NCT00873041|O1|Outcome|All Randomized Participants|Participants received a starting dose of 5 mg/kg/day or 10 mg/kg/day deferasirox tablets or matching placebo orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978009|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978010|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978011|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978012|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. Participants received a starting dose of 5 or 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978013|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978014|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978015|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978016|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978017|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978018|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978019|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978020|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978021|NCT00873041|O3|Outcome|Placebo|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978022|NCT00873041|O2|Outcome|10 mg/kg/Day Deferasirox|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978023|NCT00873041|O1|Outcome|5 mg/kg/Day Deferasirox|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation.
978024|NCT00873041|E3|Reported Event|Placebo/Deferasirox Any Dose|Placebo tablet matching 5 mg/kg/day or 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
978025|NCT00873041|E2|Reported Event|Deferasirox 10 mg/kg/Day|Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
978026|NCT00873041|E1|Reported Event|Deferasirox 5 mg/kg/Day|Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
978027|NCT00873015|B5|Baseline|Total|Total of all reporting groups
978028|NCT00873015|B4|Baseline|64 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 64 nmol/min/kg
978029|NCT00873015|B3|Baseline|48 Nmol/Min/kg|Sodium nitrite: 14 day continuous infusion 48 nmol/min/kg
978039|NCT00873015|E2|Reported Event|Vehicle Control|Nitrite : 14 day continuous infusion of a vehicle control infusion
978040|NCT00873015|E1|Reported Event|Nitrite|Sodium nitrite : 14 day continuous infusion of one of 3 escalating doses of sodium nitrite: 32 nmol/min/kg, 48 nmol/min/kg, or 64 nmol/min/kg
978041|NCT00872989|B3|Baseline|Total|Total of all reporting groups
978042|NCT00872989|B2|Baseline|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978043|NCT00872989|B1|Baseline|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978044|NCT00872989|P2|Participant Flow|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978045|NCT00872989|P1|Participant Flow|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978046|NCT00872989|O1|Outcome|Vandetanib|Patients elected to participant in the crossover registration in Vandetanib after progression in single agent docetaxel.
978047|NCT00872989|O1|Outcome|Vandetanib|Vandetanib treated patients
978048|NCT00872989|O3|Outcome|Vandetanib|
978049|NCT00872989|O2|Outcome|Docetaxel + Vandetanib|
978050|NCT00872989|O1|Outcome|Docetaxel|
978051|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978052|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978053|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978054|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978055|NCT00872989|O2|Outcome|Arm II: Docetaxel + Vandetanib|"Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978056|NCT00872989|O1|Outcome|Arm I: Docetaxel|"Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.~docetaxel: Given IV~vandetanib: Given orally"
978057|NCT00872989|E3|Reported Event|Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
978058|NCT00872989|E2|Reported Event|Docetaxel + Vandetanib|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
978059|NCT00872989|E1|Reported Event|Docetaxel|Adverse events are analyzed in the subset of patients who received at least one dose of drug.
978060|NCT00872898|B4|Baseline|Total|Total of all reporting groups
978061|NCT00872898|B3|Baseline|Part Two - Memantine|Once daily oral administration of memantine extended release for 12 weeks. Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups.
978062|NCT00872898|B2|Baseline|Part Two - Placebo|Once daily oral administration of placebo for 12 weeks.
978063|NCT00872898|B1|Baseline|Part One - Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
978064|NCT00872898|P2|Participant Flow|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978065|NCT00872898|P1|Participant Flow|Placebo|Once daily, oral administration of placebo for 12 weeks.
978066|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978067|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978068|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978069|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978070|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978071|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978072|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978073|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978117|NCT00872729|O13|Outcome|Cystagon® (6 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978074|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978075|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978076|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978077|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978078|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978079|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978080|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978081|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978082|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978083|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978084|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978085|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978086|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978087|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
978088|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978089|NCT00872898|O1|Outcome|Placebo|Once daily, oral administration of placebo for 12 weeks.
978090|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978091|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978092|NCT00872898|O2|Outcome|Memantine|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups, administered orally."
978093|NCT00872898|O1|Outcome|Placebo|Once daily oral administration of placebo for 12 weeks.
978094|NCT00872898|O1|Outcome|Memantine|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
978095|NCT00872898|E3|Reported Event|Memantine - Part One, Open Label Treatment|Patients received a single dose of 3-mg memantine extended release capsule, oral administration.
978096|NCT00872898|E2|Reported Event|Memantine - Part Two, Double-Blind Treatment|"Once daily oral administration of memantine extended release for 12 weeks.~Memantine - 3mg and 6mg capsules, dose ranging 3 - 18 mg/day in 4 weight groups."
978097|NCT00872898|E1|Reported Event|Placebo - Part Two, Double-Blind Treatment|Once daily oral administration of placebo for 12 weeks
978098|NCT00872833|B1|Baseline|Overall|Both cohorts combined
978099|NCT00872833|P2|Participant Flow|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
978100|NCT00872833|P1|Participant Flow|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
978101|NCT00872833|O4|Outcome|> 28 Days|Subjects with transfusion cycles greater than 28 days
978102|NCT00872833|O3|Outcome|22 - 28 Days|Subjects with transfusion cycles between 22 and 28 days
978103|NCT00872833|O2|Outcome|15 - 21 Days|Subjects with transfusion cycles between 15 and 21 days
978104|NCT00872833|O1|Outcome|<= 14 Days|Subjects with transfusion cycles of 14 days or less
978105|NCT00872833|O2|Outcome|Older Cohort|People age groups 30+ years with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
978106|NCT00872833|O1|Outcome|Younger Cohort|People age groups 18-29 with transfusion-dependent thalassemia who have reported at least mild degrees of pain during the main Assessment of Pain study.
978107|NCT00872833|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected as part of this observational study.
978108|NCT00872729|B1|Baseline|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg.
978109|NCT00872729|P1|Participant Flow|Cystagon® and RP103|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules,150 mg/50 mg; Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules,75 mg; Single-dose, open-label, nonrandomized, 2-period, crossover study of cysteamine bitartrate delayed-release capsules (RP103) and Cystagon®. Subjects were enrolled sequentially and received Cystagon® first followed by RP103.
978110|NCT00872729|O20|Outcome|RP103 (12 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978111|NCT00872729|O19|Outcome|Cystagon® (12 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978112|NCT00872729|O18|Outcome|RP103 (10 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978113|NCT00872729|O17|Outcome|Cystagon® (10 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978114|NCT00872729|O16|Outcome|RP103 (8 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978115|NCT00872729|O15|Outcome|Cystagon® (8 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978116|NCT00872729|O14|Outcome|RP103 (6 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
981366|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
978118|NCT00872729|O12|Outcome|RP103 (4 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978119|NCT00872729|O11|Outcome|Cystagon® (4 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978120|NCT00872729|O10|Outcome|RP103 (3 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978121|NCT00872729|O9|Outcome|Cystagon® (3 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978122|NCT00872729|O8|Outcome|RP103 (2.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978123|NCT00872729|O7|Outcome|Cystagon® (2.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978124|NCT00872729|O6|Outcome|RP103 (2 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978125|NCT00872729|O5|Outcome|Cystagon® (2 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978126|NCT00872729|O4|Outcome|RP103 (1 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978127|NCT00872729|O3|Outcome|Cystagon® (1 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978128|NCT00872729|O2|Outcome|RP103 (0.5 Hour)|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978129|NCT00872729|O1|Outcome|Cystagon® (0.5 Hour)|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978130|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978131|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978132|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978133|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978134|NCT00872729|O2|Outcome|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.
978135|NCT00872729|O1|Outcome|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.
978136|NCT00872729|E2|Reported Event|RP103|Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg
978137|NCT00872729|E1|Reported Event|Cystagon®|Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg;
978138|NCT00872599|B1|Baseline|Study Group|
978139|NCT00872599|P2|Participant Flow|Fenofibrate, Then Placebo|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received fenofibrate 160mg/d. During the second they received matching placebo.
978140|NCT00872599|P1|Participant Flow|Placebo, Then Fenofibrate|Subjects underwent two consecutive high salt (200mmol/d) periods. During the first they received matching placebo. During the second they received fenofibrate 160mg/d.
978141|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
978142|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
978143|NCT00872599|O2|Outcome|Salt-sensitive Hypertension|Subjects were classified as salt-sensitive if the average study day mean arterial pressure was at least 5 mmHg higher during high salt placebo compared to low salt intake
978144|NCT00872599|O1|Outcome|Salt-resistant Hypertension|Subjects whose average study day mean arterial pressure was less than 5 mmHg higher during high salt intake compared to low salt intake
978145|NCT00872599|E2|Reported Event|Fenofibrate|
978146|NCT00872599|E1|Reported Event|Placebo|
978147|NCT00872534|B3|Baseline|Total|Total of all reporting groups
978148|NCT00872534|B2|Baseline|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
978149|NCT00872534|B1|Baseline|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
978150|NCT00872534|P2|Participant Flow|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
978151|NCT00872534|P1|Participant Flow|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
978152|NCT00872534|O2|Outcome|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
978153|NCT00872534|O1|Outcome|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
978154|NCT00872534|E2|Reported Event|Aspirin|"Immediate release 325mg aspirin~acetylsalicylic acid: 325mg once a day for 7 days"
978155|NCT00872534|E1|Reported Event|PL-2200|"PL-2200 is an NSAID product containing 325mg of acetylsalicylic acid and phosphatidylcholine in a neutral lipid matrix.~acetylsalicylic acid: 325mg once a day for 7 days"
978156|NCT00872521|B4|Baseline|Total|Total of all reporting groups
978157|NCT00872521|B3|Baseline|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978158|NCT00872521|B2|Baseline|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978159|NCT00872521|B1|Baseline|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978160|NCT00872521|P3|Participant Flow|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978309|NCT00871780|O1|Outcome|Natalizumab: Baseline EDSS 0 to 2.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS of 0 to 2.5
981367|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
978161|NCT00872521|P2|Participant Flow|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978162|NCT00872521|P1|Participant Flow|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978163|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
978164|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
978165|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
978166|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
978167|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
978168|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
978169|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
978170|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
978171|NCT00872521|O2|Outcome|Positive|Participants with FGFR3 expression
978172|NCT00872521|O1|Outcome|Negative|Participants without FGFR3 expression
978173|NCT00872521|O2|Outcome|Positive|Participants with bcl-2 expression
978174|NCT00872521|O1|Outcome|Negative|Participants without bcl-2 expression
978175|NCT00872521|O2|Outcome|Positive|Participants with Cyclin D1 expression
978176|NCT00872521|O1|Outcome|Negative|Participants without Cyclin D1 expression
978177|NCT00872521|O2|Outcome|Positive|Participants with p53 expression
978178|NCT00872521|O1|Outcome|Negative|Participants without p53 expression
978179|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978180|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978181|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978182|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978183|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978184|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978185|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978186|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978187|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978188|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978189|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978190|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978191|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978192|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978193|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978194|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978195|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978196|NCT00872521|O3|Outcome|Failed/Missing|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978310|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978311|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978197|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978198|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978199|NCT00872521|O4|Outcome|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978200|NCT00872521|O3|Outcome|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978201|NCT00872521|O2|Outcome|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978202|NCT00872521|O1|Outcome|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978203|NCT00872521|E4|Reported Event|Total|Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978204|NCT00872521|E3|Reported Event|Failed/Missing Test|Participants who failed 1q21 test/had missing results for 1q21 test. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978205|NCT00872521|E2|Reported Event|1q21 Not Amplified|Participants without 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978206|NCT00872521|E1|Reported Event|1q21 Amplified|Participants with 1q21 amplification. Four 21-day cycles of bortezomib 1.3 mg/m2 intravenous (IV) on Days 1, 4, 8 and 11; plus doxorubicin 20 mg/m2 IV on Days 1 and 4; and dexamethasone 20 mg oral on Days 1, 2, 4, 5, 8, 9, 11 and 12.
978207|NCT00872430|B3|Baseline|Total|Total of all reporting groups
978208|NCT00872430|B2|Baseline|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
978209|NCT00872430|B1|Baseline|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
978210|NCT00872430|P2|Participant Flow|Laxative Tea First Crossover|Laxative tea in the first period and placebo in the second period (after washout period).
978211|NCT00872430|P1|Participant Flow|Placebo First Crossover|Placebo in the first period and laxative tea in the second period (after washout period)
978212|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
978213|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
978214|NCT00872430|O2|Outcome|Laxative Tea|Laxative tea administered three times a day in either first intervention period or second intervention period.
978215|NCT00872430|O1|Outcome|Placebo|Placebo administered three times a day in either first intervention period or second intervention period.
978216|NCT00872339|B4|Baseline|Total|Total of all reporting groups
978217|NCT00872339|B3|Baseline|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
978218|NCT00872339|B2|Baseline|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
978219|NCT00872339|B1|Baseline|Transfusion-dependant|People with transfusion-dependant thalassemia.
978220|NCT00872339|P3|Participant Flow|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
978221|NCT00872339|P2|Participant Flow|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
978222|NCT00872339|P1|Participant Flow|Transfusion-dependant|People with transfusion-dependant thalassemia.
978223|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
978224|NCT00872339|O1|Outcome|All Subjects Combined|Subjects were combined into one group.
978225|NCT00872339|O1|Outcome|All Subjects Combined|Subjects with pain in the last 7 days were combined into one group.
978226|NCT00872339|O3|Outcome|Non-transfusion-dependant|People with non-transfusion-dependant thalassemia.
978227|NCT00872339|O2|Outcome|Intermittently Transfused|Intermittently transfused patients- individuals who received fewer than eight transfusions in the last year
978228|NCT00872339|O1|Outcome|Transfusion-dependant|People with transfusion-dependant thalassemia.
978229|NCT00872339|E1|Reported Event|Adverse Events Were Not Collected|Adverse events were not collected for this study.
978230|NCT00872170|B3|Baseline|Total|Total of all reporting groups
978231|NCT00872170|B2|Baseline|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
978232|NCT00872170|B1|Baseline|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978233|NCT00872170|P2|Participant Flow|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
978312|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978313|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978314|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
981368|NCT00862082|O1|Outcome|PR104|
978234|NCT00872170|P1|Participant Flow|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978235|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978236|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978237|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978238|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978239|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978240|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978241|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978242|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978243|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978244|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978245|NCT00872170|O1|Outcome|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978246|NCT00872170|E2|Reported Event|Control|Participants with thalassemia who do not have pulmonary hypertension were part of a control group and were only undergoing screening/baseline assessments.
978247|NCT00872170|E1|Reported Event|Sildenafil|"Participants with thalassemia who have pulmonary hypertension received sildenafil for 12 weeks.~Sildenafil : Participants received sildenafil for 12 weeks with the following therapy:~50 mg of oral sildenafil three times a day (TID) increased to 100 mg TID as tolerated in adults and children greater than 50 kg; 1 mg/kg sildenafil TID without dose escalation in children less than 50 kg"
978248|NCT00872079|B1|Baseline|Genomics|"The specific aims of this research are:~Determine the structure and the type of neural network model for predictions from historically obtained data. (Computer Model)~Prospectively develop an individualized neural network and NONMEM model capable of predicting erythropoietin dosing for chronic in-center hemodialysis patients using adaptive techniques.~Develop computer programs based on neural computing that can be used in a clinical setting. (Computer Model)~Determine the utility of the computer programs prospectively in the clinical setting."
978249|NCT00872079|P1|Participant Flow|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
978315|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978316|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978317|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978318|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978319|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978320|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978250|NCT00872079|O1|Outcome|Genomics|"Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.~There are 4 Aims in this study.~To collect historical data on warfarin dosing in subjects.~To collect genotype information on up to 300 subjects receiving warfarin anticoagulation.~to develop a computer model incorporating the information from aim 1 and aim 2.~To conduct a randomized clinical trial."
978251|NCT00872079|E1|Reported Event|Genomics|Model Predictive Control: Model predictive control is a computer based algorithm that can be applied to drug dosing. This computer tool uses a model of how a patient will respond to a drug dose based on demographic and historical dosing information to predict a new drug response. A drug dose controller applies all possible doses to the response model and selects the one dose that best meets the stated goals of the drug therapy. In the case of warfarin, we will calculate an INR value within a specific target range.
978252|NCT00872027|B3|Baseline|Total|Total of all reporting groups
978253|NCT00872027|B2|Baseline|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
978254|NCT00872027|B1|Baseline|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
978255|NCT00872027|P2|Participant Flow|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
978256|NCT00872027|P1|Participant Flow|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
978257|NCT00872027|O2|Outcome|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
978258|NCT00872027|O1|Outcome|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
978259|NCT00872027|E2|Reported Event|Participants Will Receive 8 Weeks of Placebo Pills.|"Participants will receive 8 weeks of placebo pills.~Placebo: Placebo pills for 8 weeks"
978260|NCT00872027|E1|Reported Event|Participants Will Receive 8 Weeks of Escitalopram Treatment.|"Participants will receive 8 weeks of escitalopram treatment.~Escitalopram: 10 mg of escitalopram administered enterally with the option for dose escalation to 20 mg after 3 to 5 weeks if the medical condition is stable and no liver disease presents"
978261|NCT00872001|B3|Baseline|Total|Total of all reporting groups
978262|NCT00872001|B2|Baseline|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
978263|NCT00872001|B1|Baseline|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
978264|NCT00872001|P2|Participant Flow|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
978265|NCT00872001|P1|Participant Flow|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
978266|NCT00872001|O2|Outcome|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
978267|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
978268|NCT00872001|O2|Outcome|Placebo|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB.
978269|NCT00872001|O1|Outcome|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB).
978270|NCT00872001|E2|Reported Event|Placebo (Normal Saline)|Placebo (normal saline) IV infusion, plus cardioplegia solution with added normal saline, and priming solution with added normal saline in the heart lung machine during CPB
978271|NCT00872001|E1|Reported Event|Acadesine|Acadesine IV infusion, plus cardioplegia solution with acadesine, and priming solution with acadesine in the heart lung machine during cardiopulmonary bypass (CPB)
978272|NCT00871975|B1|Baseline|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
978321|NCT00871780|O1|Outcome|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978322|NCT00871780|E1|Reported Event|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978323|NCT00871741|B3|Baseline|Total|Total of all reporting groups
978324|NCT00871741|B2|Baseline|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978939|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
978273|NCT00871975|P1|Participant Flow|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
978274|NCT00871975|O1|Outcome|Urodynamics + Tetra NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
978275|NCT00871975|E1|Reported Event|Urodynamics + Tetra-NIRS|Single arm - all patients were recruited following a requirement for urodynamic testing. The patient is the invited to the clinic room to perform the urodynamics test concurrently with the Tetra-NIRS device. The clinic staff perform urodynamics per their standard protocol, with the Tetra-NIRS patch applied externally above the location of the bladder. The numerical pressure data resulting from the urodynamics machine plus the hemoglobin levels (oxygenated and deoxygenated) measured by the Tetra-NIRS device are displayed on a computer and saved. The test would take approx. 45 minutes to perform, after which time the patient is free to go home. Interpretation of the Tetra-NIRS had no bearing on the patients' diagnosis, however urodynamic interpretation was performed per their standard protocol.
978276|NCT00871871|B3|Baseline|Total|Total of all reporting groups
978277|NCT00871871|B2|Baseline|All Part II Participants|Part II Overall: Isosorbide mononitrate (ISMN)in Period 1, followed by placebo in Period 2 or placebo in Period 1, followed by ISMN in Period 2
978278|NCT00871871|B1|Baseline|All Part I Participants|Part I Overall: Hydrochlorothiazide (HCTZ) in Period 1 followed by Placebo in Period 2 or Placebo in Period 1, followed by HCTZ in Period 2
978279|NCT00871871|P4|Participant Flow|ISMN Placebo First, Then ISMN|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
978280|NCT00871871|P3|Participant Flow|ISMN First, Then ISMN Placebo|Part II Overall: Placebo in Period 1, followed by isosorbide mononitrate (ISMN) in Period 2 or ISMN in Period 1, followed by placebo in Period 2
978281|NCT00871871|P2|Participant Flow|HCTZ Placebo First, Then HCTZ|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
978282|NCT00871871|P1|Participant Flow|HCTZ First, Then HCTZ Placebo|Part I Overall: Placebo in Period 1 followed by hydrochlorothiazide (HCTZ) in Period 2 or HCTZ in Period 1, followed by placebo in Period 2
978283|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
978284|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
978285|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
978286|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
978287|NCT00871871|O2|Outcome|Isosorbide Mononitrate (ISMN) Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
978288|NCT00871871|O1|Outcome|Isosorbide Mononitrate (ISMN)|Part II: Participants on ISMN in either Period 1 or Period 2
978289|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
978290|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
978291|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
978292|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
978293|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
978294|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
978295|NCT00871871|O2|Outcome|Hydrochlorothiazide (HCTZ) Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
978296|NCT00871871|O1|Outcome|Hydrochlorothiazide (HCTZ)|Part I: Participants on HCTZ in either Period 1 or Period 2
978297|NCT00871871|E4|Reported Event|ISMN Placebo|Part II: Participants on ISMN Placebo in either Period 1 or Period 2
978298|NCT00871871|E3|Reported Event|ISMN|Part II: Participants on ISMN in either Period 1 or Period 2
978299|NCT00871871|E2|Reported Event|HCTZ Placebo|Part I: Participants on HCTZ Placebo in either Period 1 or Period 2
978300|NCT00871871|E1|Reported Event|HCTZ|Part I: Participants on HCTZ in either Period 1 or Period 2
978301|NCT00871819|B1|Baseline|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
978302|NCT00871819|P1|Participant Flow|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
978303|NCT00871819|O1|Outcome|All Subjects|All enrolled subjects
978304|NCT00871819|E1|Reported Event|Spinal Cord Stimulation Group|Spinal Cord Stimulation (SCS) Treatment Group
978305|NCT00871780|B1|Baseline|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978306|NCT00871780|P1|Participant Flow|Natalizumab|natalizumab 300 mg IV every 4 weeks for 48 weeks
978307|NCT00871780|O3|Outcome|Natalizumab: Baseline EDSS >= 4.5|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS >= 4.5
978308|NCT00871780|O2|Outcome|Natalizumab: Baseline EDSS 3.0 to 4.0|natalizumab 300 mg IV every 4 weeks for 48 weeks in participants with a Baseline EDSS 3.0 to 4.0
978325|NCT00871741|B1|Baseline|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978326|NCT00871741|P2|Participant Flow|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978327|NCT00871741|P1|Participant Flow|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978328|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978329|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978330|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978331|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978332|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978333|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978334|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978335|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978336|NCT00871741|O2|Outcome|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978337|NCT00871741|O1|Outcome|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978338|NCT00871741|E2|Reported Event|Infanrix + Menjugate Group|Subjects in this group were to receive three doses of Infanrix™ hexa vaccine at 3, 5 and 11 months of age, and two doses of Menjugate® vaccine at 3 and 5 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978339|NCT00871741|E1|Reported Event|GSK2202083A Group|Subjects in this group were to receive three doses of GSK2202083A vaccine at 3, 5 and 11 months of age, as an intramuscular injection in the anterolateral quadrant of the right thigh.
978340|NCT00871728|B1|Baseline|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978341|NCT00871728|P1|Participant Flow|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978342|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978343|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978344|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978345|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978346|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978347|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978348|NCT00871728|O1|Outcome|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978389|NCT00871624|O2|Outcome|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978349|NCT00871728|E1|Reported Event|Itraconazole|Itraconazole (ICZ) capsule was administered in 3 cycles (Week 1, Week 5 and Week 9) and each cycle consists of taking 2 capsules of 100 milligram (mg) each, orally twice daily, continuously for 1 week and then not taking medication for next 3 weeks. Total duration of treatment was 49 weeks.
978350|NCT00871715|B4|Baseline|Total|Total of all reporting groups
978351|NCT00871715|B3|Baseline|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
978352|NCT00871715|B2|Baseline|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
978353|NCT00871715|B1|Baseline|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
978354|NCT00871715|P3|Participant Flow|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
978355|NCT00871715|P2|Participant Flow|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
978356|NCT00871715|P1|Participant Flow|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
978357|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
978358|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
978359|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
978360|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
978390|NCT00871624|O1|Outcome|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978391|NCT00871624|E2|Reported Event|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978940|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
978361|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
978362|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
978363|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
978364|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
978365|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
978366|NCT00871715|O3|Outcome|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
978367|NCT00871715|O2|Outcome|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
978368|NCT00871715|O1|Outcome|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
978369|NCT00871715|E4|Reported Event|Screened But Not Randomized|Individuals who consented to an in-person screening assessment for eligibility but were never randomized.
978370|NCT00871715|E3|Reported Event|UCC Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was administered early post-acutely in the outpatient setting according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Usual and Customary Care (UCC): This was an observation only group; treatment dose was prescribed and provided in accordance with usual and customary practices."
978371|NCT00871715|E2|Reported Event|DEUCC Dose-Equivalent Usual & Customary Care|"Therapy content was not structured or standardized across therapists or sites. Usual and customary occupational therapy was adjusted for dose and administered early post-acutely in the outpatient setting. It consisted of usual and customary outpatient occupational therapy according to local practices, payer guidelines and participant preferences. It may have focused on more diverse needs than the affected upper extremity.~Dose-Equivalent Usual & Customary Care (DEUCC): This group was prescribed a 30-hour dose equivalency, administered over 1-hour visits at a frequency of 3x/week for a 10-week duration."
978392|NCT00871624|E1|Reported Event|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978393|NCT00871494|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
978394|NCT00871494|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
978372|NCT00871715|E1|Reported Event|ASAP Accelerated Skill Acquisition Program|"A structured, evidence-based, task-oriented rehabilitation program was administered during the early post-acute outpatient interval. It focused entirely on recovery of the affected upper extremity. The training intervention was based on the fundamental elements of skill acquisition through intense bouts of task-specific practice, impairment mitigation (strengthening exercises, shoulder stability/mobility, etc.) to increase capacity, and motivational enhancements to build self-confidence and autonomy.~Accelerated Skill Acquisition Program (ASAP): The prescribed dose was 30-hours administered over 1-hour visits at a frequency of 3x/week for a 10-week duration. A 2-hour orientation/evaluation session preceded the first visit."
978373|NCT00871689|B1|Baseline|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978374|NCT00871689|P1|Participant Flow|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978375|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978376|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978377|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978378|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978379|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978380|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978381|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978382|NCT00871689|O1|Outcome|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978383|NCT00871689|E1|Reported Event|Patients Receiving Double Umbilical Cord Blood Transplant|Patients that receive myeloablative preparative regimen (allopurinol 300 mg by mouth Day -8 through +14; fludarabine 25 mg/m^2 intravenously on days -7 through -5; cyclophosphamide 60 mg/kg intravenously on days -7 and -6; total body irradiation 165 cGy*2 on days -4 through -2), 2 units T cell depleted umbilical cord blood transplant on day 0, followed by IL-2 every other day beginning day +3 and day +60 for a total of 6 doses.
978384|NCT00871624|B3|Baseline|Total|Total of all reporting groups
978385|NCT00871624|B2|Baseline|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978386|NCT00871624|B1|Baseline|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978387|NCT00871624|P2|Participant Flow|Placebo|Placebo: Placebo infusion will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978388|NCT00871624|P1|Participant Flow|Dexmedetomidine|Dexmedetomidine: Dexmedetomidine will be started at a rate of 0.2mcg/kg/hr and titrated by 0.1 mcg/kg/hr every 30 minutes to a maximum of 0.7 mcg/kg/hr to maintain a Riker-SAS 3-4.
978395|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
978396|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
978397|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
978398|NCT00871494|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
978399|NCT00871494|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 1 to 2 days to 250 mg oral azithromycin once daily to complete a total of 7 days therapy)
978400|NCT00871429|B1|Baseline|Cancer Patients Using Lindi Skin Products|
978401|NCT00871429|P1|Participant Flow|Lindi Skin Participant Flow|
978402|NCT00871429|O3|Outcome|Lindi Skin Face Serum (Product B)|
978403|NCT00871429|O2|Outcome|Lindi Skin Face Wash (Product C)|
978404|NCT00871429|O1|Outcome|Lindi Skin Soothing Balm (Product A)|
978405|NCT00871429|E3|Reported Event|Lindi Skin Face Serum (Product B)|
978406|NCT00871429|E2|Reported Event|Lindi Skin Face Wash (Product C)|
978407|NCT00871429|E1|Reported Event|Lindi Skin Soothing Balm (Product A)|
978408|NCT00871403|B4|Baseline|Total|Total of all reporting groups
978409|NCT00871403|B3|Baseline|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
978410|NCT00871403|B2|Baseline|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
978411|NCT00871403|B1|Baseline|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
978412|NCT00871403|P3|Participant Flow|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
978413|NCT00871403|P2|Participant Flow|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
978414|NCT00871403|P1|Participant Flow|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
978415|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
978416|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
978417|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
978418|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
978419|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
978420|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
978458|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978941|NCT00869947|O3|Outcome|Non-amputees|
978421|NCT00871403|O2|Outcome|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
978422|NCT00871403|O1|Outcome|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
978423|NCT00871403|E3|Reported Event|Cisplatin 75 mg/m^2 Plus Pemetrexed 500 mg/m^2|IV cisplatin 75 mg/m^2 plus intravenous pemetrexed 500 mg/m^2 once daily every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. Until Protocol Amendment 2, upon disease progression participants had the opportunity to receive pazopanib 800 mg monotherapy if the investigator considered it an appropriate treatment option after considering alternative options for second-line treatment.
978424|NCT00871403|E2|Reported Event|Pazopanib 800 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 800 mg once daily plus intravenous (IV) pemetrexed 500 mg/ m^2 once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase. If participants experienced no disease progression, unacceptable toxicities, or death during the Combination Treatment Phase, they continued on pazopanib 800 mg monotherapy until disease progression, unacceptable toxicities, or death.
978425|NCT00871403|E1|Reported Event|Pazopanib 600 mg Plus Pemetrexed 500 mg/m^2|Oral pazopanib 600 milligrams (mg) once daily plus intravenous pemetrexed 500 mg/meters squared (m^2) once every 3 weeks for 4 or 6 cycles during the Combination Treatment Phase.
978426|NCT00871377|B1|Baseline|Baseline|The study began on Visit 1 when baseline data was collected and Intervention 1 was initiated.
978427|NCT00871377|P6|Participant Flow|H P L|High Dose, then Placebo, then Low Dose
978428|NCT00871377|P5|Participant Flow|H L P|High Dose, then Low Dose, then Placebo
978429|NCT00871377|P4|Participant Flow|L P H|Low Dose, then Placebo, then High Dose
978430|NCT00871377|P3|Participant Flow|L H P|Low Dose, then High Dose, then Placebo
978431|NCT00871377|P2|Participant Flow|P H L|Placebo, then High Dose, then Low Dose
978432|NCT00871377|P1|Participant Flow|P L H|Placebo, then Low Dose, then High Dose
978433|NCT00871377|O3|Outcome|Fish OIl High Dose|Fish Oil - 6 capsules per day EPA+DHA = 2160 mg/day
978434|NCT00871377|O2|Outcome|Fish Oil Low Dose|Fish Oil - 3 capsules per day Corn Oil - 3 capsules per day EPA+DHA = 1080 mg/day
978435|NCT00871377|O1|Outcome|Placebo|Corn Oil - 6 capsules per day
978436|NCT00871377|E3|Reported Event|Placebo|Corn Oil Placebo
978437|NCT00871377|E2|Reported Event|Low Dose|Low Dose Fish Oil Intervention
978438|NCT00871377|E1|Reported Event|High Dose|High Dose Fish Oil Intervention
978439|NCT00871351|B4|Baseline|Total|Total of all reporting groups
978440|NCT00871351|B3|Baseline|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978441|NCT00871351|B2|Baseline|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978442|NCT00871351|B1|Baseline|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978443|NCT00871351|P3|Participant Flow|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978444|NCT00871351|P2|Participant Flow|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978445|NCT00871351|P1|Participant Flow|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978446|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978447|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978448|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978449|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978450|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978451|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978452|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978453|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978454|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978455|NCT00871351|O3|Outcome|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978456|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978457|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978459|NCT00871351|O2|Outcome|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978460|NCT00871351|O1|Outcome|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978461|NCT00871351|E3|Reported Event|Rosuvastatin|Participants with hypercholesterolemia receiving rosuvastatin 2.5 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978462|NCT00871351|E2|Reported Event|Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 20 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978463|NCT00871351|E1|Reported Event|Ezetimibe + Atorvastatin|Participants with hypercholesterolemia receiving atorvastatin 10 mg and ezetimibe 10 mg for 12 weeks after a 4-week washout and 4 weeks of daily atorvastatin 10 mg
978464|NCT00871338|B3|Baseline|Total|Total of all reporting groups
978465|NCT00871338|B2|Baseline|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978466|NCT00871338|B1|Baseline|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978467|NCT00871338|P2|Participant Flow|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978468|NCT00871338|P1|Participant Flow|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978469|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978470|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978471|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978472|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978473|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978474|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978475|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978942|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
981369|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
978476|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978477|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978478|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978479|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978480|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978481|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978482|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978483|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978484|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978485|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978486|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978487|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978488|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978598|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978489|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978490|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978491|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978492|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978493|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978494|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978495|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978496|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978497|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978498|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978499|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978500|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978501|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978676|NCT00870740|B1|Baseline|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978502|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978503|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978504|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978505|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978506|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978507|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978508|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978509|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978510|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978511|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978512|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978513|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978514|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978599|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978515|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978516|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978517|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978518|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978519|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978520|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978521|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978522|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978523|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978524|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978525|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978526|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978527|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978677|NCT00870740|P6|Participant Flow|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978528|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978529|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978530|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978531|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978532|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978533|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978534|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978535|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978536|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978537|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978538|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978539|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978540|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978600|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978541|NCT00871338|O2|Outcome|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978542|NCT00871338|O1|Outcome|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978543|NCT00871338|E2|Reported Event|Pediacel Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of Pediacel™ vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2, 2 doses of Menjugate™ vaccine at Months 1 and 2 and a booster dose of Menitorix™ at Month 10. All vaccines were administered intramuscularly. Pediacel™ and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh and Menjugate™ vaccine in the left lower anterolateral thigh.
978544|NCT00871338|E1|Reported Event|GSK2197870A Group|Subjects aged between and including 6 and 12 weeks of age at the time of first vaccination received 3 doses of GSK2197870A vaccine at Months 0, 1 and 2, 2 doses of Prevenar™ vaccine at Months 0 and 2 and a booster dose of Menitorix™ vaccine at Month 10. All vaccines were administered intramuscularly. GSK2197870A and Menitorix™ vaccines were administered in the right upper anterolateral thigh and Prevenar™ vaccine in the left upper anterolateral thigh.
978545|NCT00871286|B3|Baseline|Total|Total of all reporting groups
978546|NCT00871286|B2|Baseline|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
978547|NCT00871286|B1|Baseline|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
978548|NCT00871286|P2|Participant Flow|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
978549|NCT00871286|P1|Participant Flow|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
978550|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
978551|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
978552|NCT00871286|O2|Outcome|CT Scan (Sinus) Post-tx|
978553|NCT00871286|O1|Outcome|CT Scan (Sinus) Pre-tx|
978554|NCT00871286|E2|Reported Event|CT Scan (Sinus) Post-tx|Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
978555|NCT00871286|E1|Reported Event|CT Scan (Sinus) Pre-tx|Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event.
978556|NCT00871234|B1|Baseline|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
978557|NCT00871234|P1|Participant Flow|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
978558|NCT00871234|O1|Outcome|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
978559|NCT00871234|E1|Reported Event|Etravirine|Healthy volunteers receiving etravirine 200mg orally twice daily
978560|NCT00871169|B1|Baseline|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
978561|NCT00871169|P1|Participant Flow|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
978562|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
978601|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978563|NCT00871169|O1|Outcome|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
978564|NCT00871169|E1|Reported Event|Irinotecan, Oxaliplatin, and Cetuximab|"The goal is to administer at least 4 cycles to each patient, but treatment may stop earlier if the treating physician deems stopping to be in the best interest of the patient. Repeated treatment may be given to patients who benefit (either complete or partial response or stabilization of disease)~Irinotecan, oxaliplatin, and cetuximab: Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes).~The treatment interval (one cycle) is every 14 days."
978565|NCT00871143|B3|Baseline|Total|Total of all reporting groups
978566|NCT00871143|B2|Baseline|Non Specific CBT|Anxiety Management treatment was provided once a week for 12 weeks, with each session lasting 1 hr. AM was planned to entail a therapeutic alliance, support and homework similar to the CBT group. The rationale provided was that when triggered, the person would experience a threat and negative thoughts about their appearance. This, in turn, would lead to physical symptoms of anxiety and magnify the perceived threat. The treatment consisted of (1) practising progressive muscle relaxation and breathing daily, (2) identifying triggers and physical symptoms associated with appearance-related anxiety and (3) utilising brief muscle relaxation and breathing techniques in trigger situations.
978567|NCT00871143|B1|Baseline|CBT Specific for BDD|This consisted of 12 wks of 1 hr sessions (1 per week).The consisted of engagement in a developmental understanding of the problem and setting up an alternative view of the problem. Imagery rescripting followed for past aversive memories that were associated with the onset (e.g. bullying). The behaviours were aimed at either (1) threat detection and monitoring or (2) preventing feared consequences by avoidance or (3) attempts to undo the appearance concerns. The therapist aimed to help individuals identify their beliefs about processes, conduct behavioural experiments that tested out their expectations and to gradually drop the safety-seeking behaviours and test out their fears.
978568|NCT00871143|P2|Participant Flow|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits of anxiety management were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978569|NCT00871143|P1|Participant Flow|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978570|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978571|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978572|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978573|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978574|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978575|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978576|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978577|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978578|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978579|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978580|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978581|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978582|NCT00871143|O2|Outcome|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978583|NCT00871143|O1|Outcome|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978584|NCT00871143|E2|Reported Event|Non Specific CBT|Non specific CBT: CBT which is not specific for BDD (stress management and cognitive restructuring) which has been shown to be a credible alternative psychological treatment to CBT in health anxiety. However in two pilot cases of BDD, the benefits were minimal with a reduction of between zero and 10% on the YBOCS for BDD. At the most this equates to a maximum of 3 points reduction.
978585|NCT00871143|E1|Reported Event|CBT Specific for BDD|CBT specific for BDD: Cognitive behaviour therapy (CBT) which is specific for BDD. A pilot study (Veale et al, 1996b) twelve years ago has demonstrated significant benefit of CBT over a waiting list. The mean reduction was about 50% on the primary outcome measure (YBOCS for BDD). This consisted of a reduction of 12 points and a standard deviation of 7 on the YBOCS for BDD and the treatment is now thought to be better than in 1996.
978586|NCT00871117|B3|Baseline|Total|Total of all reporting groups
978587|NCT00871117|B2|Baseline|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978588|NCT00871117|B1|Baseline|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978589|NCT00871117|P2|Participant Flow|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978590|NCT00871117|P1|Participant Flow|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978591|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978592|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978593|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978594|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978595|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978596|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978597|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978602|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978603|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978604|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978605|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978606|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978607|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978608|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978609|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978610|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978611|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978612|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978613|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978614|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978615|NCT00871117|O2|Outcome|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978616|NCT00871117|O1|Outcome|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix, intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II and Varivax each, subcutaneously in the deltoid of the right upper and lower arm, respectively.
978617|NCT00871117|E2|Reported Event|Kinrix + M-M-R II -> Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm. At Day 30 they received one dose of Varivax subcutaneously in the deltoid region of the right upper arm.
978618|NCT00871117|E1|Reported Event|Kinrix + M-M-R II + Varivax|Subjects received at Day 0 one dose of Kinrix,intramuscularly in the deltoid region of the left upper arm, co-administered with one dose of M-M-R II, subcutaneously in the deltoid of the right upper arm, and one dose of Varivax subcutaneously in the deltoid region of the right lower arm.
978619|NCT00871000|B3|Baseline|Total|Total of all reporting groups
978620|NCT00871000|B2|Baseline|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978621|NCT00871000|B1|Baseline|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978670|NCT00870740|B7|Baseline|Total|Total of all reporting groups
978671|NCT00870740|B6|Baseline|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978943|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
978622|NCT00871000|P2|Participant Flow|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978623|NCT00871000|P1|Participant Flow|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978624|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978625|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978626|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978627|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978628|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978629|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978630|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978631|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978632|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978633|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978672|NCT00870740|B5|Baseline|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978673|NCT00870740|B4|Baseline|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978634|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978635|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978636|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978637|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978638|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978639|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978640|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978641|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978642|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978643|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978644|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978645|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978646|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978647|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978648|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978649|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978650|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978651|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978652|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978653|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978654|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978655|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978656|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978657|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978658|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978674|NCT00870740|B3|Baseline|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978675|NCT00870740|B2|Baseline|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978659|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978660|NCT00871000|O2|Outcome|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978661|NCT00871000|O1|Outcome|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978662|NCT00871000|E2|Reported Event|Tetravac Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Tetravac™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Tetravac™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978663|NCT00871000|E1|Reported Event|Boostrix Polio Group|Healthy male or female children, between and including 5 to 6 years of age, who were primed with three doses of Infanrix™ vaccine according to the Italian 3-5-11 month vaccination schedule, additionally received a single booster dose of Boostrix Polio™ vaccine co-administered with a single dose of Priorix Tetra™ vaccine at Day 0. Boostrix Polio™ vaccine was administered intramuscularly in the deltoid region of the left upper arm, while the Priorix Tetra™ vaccine was administered subcutaneously in the deltoid region of the right upper arm.
978664|NCT00870896|B1|Baseline|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
978665|NCT00870896|P1|Participant Flow|Group 1|Capsaicin Inhalation challenge (CIH): Each solution of capsaicin administered to a subject will be quantified by HPLC. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until two or more coughs (C2) and five or more coughs (C5) are reached. The different concentrations are delivered at 2 minute intervals. CIH is administered at baseline one and 3 months following treatment with Spiriva
978666|NCT00870896|O1|Outcome|Change in FEV1/FVC|We measured the change in FEV1/FVC ratio before and after treatment with Spiriva. Change in ratio reflects the percentage value at 30 days minus the percentage value at baseline
978667|NCT00870896|O1|Outcome|Spirometry|We measured the change in FEV1 (in liters) at baseline and following 30 days of treatment with Spiriva.Spirometry will be performed with a KoKO Spirometer, which uses a pneumotachograph to provide Flow/Volume Loops and Volume/Time graphics and multiple incentive graphics for patient coaching. Spirometry will be performed at baseline and at 4 weeks. Normal values will be those of Hankinson, et al (Am J Respir Crit Care Med 159:179-187). Spirometry will also be performed after each dose of inhaled capsaicin. If there is a drop of 20% or more in FEV1 at any time after inhalation of capsaicin, the protocol will be ended at that point.
978668|NCT00870896|O1|Outcome|Group 1|Capsaicin Inhalation Challenge Testing (CICT) will follow the protocol of Dicpinigaitis et al (Chest 2003; 123:685-8). CICT will be performed at baseline before beginning treatment with tiotropium and at 4 weeks after initiation of treatment. Solutions of capsaicin are prepared to make a stock solution of 0.01 Mol and subsequently further diluted with physiologic saline solution to yield 11 serial doubling concentrations from 0.98 to 1,000 uMol/L. Final diluted capsaicin concentrations are: 0.98, 1.95, 3.9, 7.8, 15.6, 31.2, 62.5, 125, 250, 500, and 1000 uMol/L. Single breaths of capsaicin are delivered in ascending order, with normal saline solution randomly interspersed to increase challenge blindness, until five or more coughs (C5) are reached. We measured the change in the number of coughs at baseline and following 30 days of treatment with spiriva
978669|NCT00870896|E1|Reported Event|Tiotropium|Subjects 40-80 with > 10 pk/year or ex-smoker stopped within 1 year with 10 pk/year smoking history, Subjects with mild and moderate COPD defined by ATS/ERS clinically stable for 4 weeks, subjects off tiotropium or ipratropium 1 month prior to start, Chronic cough Defined by ATS/ERS Exclusion:Age < 40 or > 80, Refusal to volunteer, Lung disease other than COPD,O2 or ventilator dependent COPD, Received antibiotics or a change in inhaled steroid during last 4 weeks.History CHF, cardiomyopathy, valvular heart disease, angina, arrhythmia, MI or uncontrolled HTN within last 6 months, History chronic hepatitis/cirrhosis, End-stage renal disease, neurologic or psychiatric disorder, Physician diagnosis GERD/allergic/non-allergic rhinitis/sinusitis/lung cancer/radiation to the chest or mediastinum/Lung volume reduction surgery/lobectomy/pneumonectomy/thoracotomy, Symptomatic BPH/bladder outlet obstruction/glaucoma Severe COPD defined ERS/ATS, Allergic response or history of allergy to lactose
978678|NCT00870740|P5|Participant Flow|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978679|NCT00870740|P4|Participant Flow|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978680|NCT00870740|P3|Participant Flow|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978681|NCT00870740|P2|Participant Flow|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978682|NCT00870740|P1|Participant Flow|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978683|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978684|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978685|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978686|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978687|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978688|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978689|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
978690|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
978691|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
978692|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978693|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978694|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978695|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978696|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978697|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978698|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978699|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978700|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978701|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978702|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978703|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978704|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978705|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978706|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978707|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978708|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978709|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978710|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978711|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978712|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978713|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978714|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978715|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978716|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978717|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978718|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978719|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978720|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978721|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978722|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
978723|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
978724|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
978725|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 13 doses.
978726|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC every 4 weeks for a total of 8 doses.
978727|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
978728|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978729|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978730|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978731|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978732|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978733|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978734|NCT00870740|O3|Outcome|DAC HYP for 2 Years|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 13 doses.
978735|NCT00870740|O2|Outcome|DAC HYP + Washout|Participants who previously received DAC HYP 150 mg or 300 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg or 300 mg SC, respectively, every 4 weeks for a total of 8 doses.
978736|NCT00870740|O1|Outcome|Placebo + DAC HYP|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg or 300 mg SC injection every 4 weeks for a total of 13 doses.
978737|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978738|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978739|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978740|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978741|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978742|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978743|NCT00870740|O6|Outcome|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978744|NCT00870740|O5|Outcome|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978745|NCT00870740|O4|Outcome|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978746|NCT00870740|O3|Outcome|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978747|NCT00870740|O2|Outcome|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978748|NCT00870740|O1|Outcome|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978749|NCT00870740|E6|Reported Event|DAC HYP 300 mg for 2 Years|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC every 4 weeks for a total of 13 doses.
978750|NCT00870740|E5|Reported Event|DAC HYP 300 mg + Washout|Participants who previously received DAC HYP 300 mg SC in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 300 mg SC every 4 weeks for a total of 8 doses.
978751|NCT00870740|E4|Reported Event|DAC HYP 150 mg for 2 Years|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) received DAC HYP 150 mg SC every 4 weeks for a total of 13 doses.
978752|NCT00870740|E3|Reported Event|DAC HYP 150 mg + Washout|Participants who previously received DAC HYP 150 mg SC injection in study 205MS201 (NCT00390221) underwent a washout period (placebo SC every 4 weeks for a total of 5 doses) and then received DAC HYP 150 mg SC every 4 weeks for a total of 8 doses.
978753|NCT00870740|E2|Reported Event|Placebo + DAC HYP 300 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 300 mg SC injection every 4 weeks for a total of 13 doses.
978754|NCT00870740|E1|Reported Event|Placebo + DAC HYP 150 mg|Participants who previously received placebo in study 205MS201 (NCT00390221) received DAC HYP 150 mg subcutaneous (SC) injection every 4 weeks for a total of 13 doses.
978755|NCT00870688|B1|Baseline|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
978756|NCT00870688|P1|Participant Flow|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
978757|NCT00870688|O1|Outcome|Sodium Valproate|Epilepsy patients receive valproate sustained release minitablets, once daily.
978758|NCT00870584|B3|Baseline|Total|Total of all reporting groups
978759|NCT00870584|B2|Baseline|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
978760|NCT00870584|B1|Baseline|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
978761|NCT00870584|P2|Participant Flow|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
978762|NCT00870584|P1|Participant Flow|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
978763|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
978764|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
978765|NCT00870584|O2|Outcome|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
978766|NCT00870584|O1|Outcome|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
978767|NCT00870584|E2|Reported Event|Placebo|Placebo was administered subcutaneously every 2 weeks or every 4 weeks depending on the dosing schedule in the protocol.
978768|NCT00870584|E1|Reported Event|Omalizumab|The determined dose (at least 0.016 mg/kg/IgE (IU/mL) was administered subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
978803|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978769|NCT00870545|B1|Baseline|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
978770|NCT00870545|P1|Participant Flow|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
978771|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
978772|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
978773|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
978774|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
978775|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
978776|NCT00870545|O1|Outcome|Telephone Support|There was one intervention. Participants were enrolled in one of 14 telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support through 12 hour-long structured sessions. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND, including Bonds, Adding and subtracting family roles, Taking control, Talking it out, Loyalty and commitment, Emotional balance, Mental health and readiness, Independence and interdependence, Navigating the system, Denial of self and a concluding session entitled Moving forward.
978777|NCT00870545|E1|Reported Event|Telephone Support|"12 telephone support groups based on the letters of the word BATTLEMIND~Telephone support groups : 12 hour-long structured telephone groups (each with a trained Group Leader and 6 participants) will focus on education, training in and practice of coping skills and cognitive restructuring (identifying and re-shaping negative and destructive thoughts), and support. The content, modeled on Soldier BATTLEMIND, targets readjustment concepts based on the letters of BATTLEMIND."
978778|NCT00870467|B3|Baseline|Total|Total of all reporting groups
978779|NCT00870467|B2|Baseline|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978780|NCT00870467|B1|Baseline|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978781|NCT00870467|P6|Participant Flow|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978829|NCT00870363|B5|Baseline|Total|Total of all reporting groups
978782|NCT00870467|P5|Participant Flow|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978783|NCT00870467|P4|Participant Flow|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978784|NCT00870467|P3|Participant Flow|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978785|NCT00870467|P2|Participant Flow|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978786|NCT00870467|P1|Participant Flow|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978787|NCT00870467|O1|Outcome|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
978788|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978789|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978790|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978791|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978792|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978793|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978794|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978795|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978796|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978797|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978798|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978799|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978800|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978801|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978802|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978944|NCT00869947|O3|Outcome|Non-amputees|
978804|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978805|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978806|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978807|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978808|NCT00870467|O4|Outcome|DB Placebo/RE OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978809|NCT00870467|O3|Outcome|DB Adalimumab/RE OL Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and then open-label adalimumab 40 mg SC eow as rescue treatment (as eligible) to complete 26 weeks, followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978810|NCT00870467|O2|Outcome|DB Placebo/OL Adalimumab|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants received concomitant methotrexate 6 to 8 mg administered orally weekly.
978811|NCT00870467|O1|Outcome|DB Adalimumab/OL Adalimumab|Participants received double-blind adalimumab administered subcutaneously (SC) every other week (eow) for 26 weeks followed by open-label adalimumab 40 mg SC eow for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978812|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978813|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978814|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978815|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978816|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978817|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978818|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978819|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978820|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978821|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978822|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978823|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978824|NCT00870467|O2|Outcome|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978825|NCT00870467|O1|Outcome|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978826|NCT00870467|E3|Reported Event|Any Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) and/or open-label adalimumab 40 mg SC eow, including as rescue treatment.
978827|NCT00870467|E2|Reported Event|DB Placebo|Participants received double-blind placebo administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978828|NCT00870467|E1|Reported Event|DB Adalimumab|Participants received double-blind adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for up to 26 weeks. Participants also received concomitant methotrexate 6 to 8 mg administered orally weekly.
978831|NCT00870363|B3|Baseline|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978832|NCT00870363|B2|Baseline|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978833|NCT00870363|B1|Baseline|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978834|NCT00870363|P4|Participant Flow|HIV Negative Controls Not on ART|HIV-negative
978835|NCT00870363|P3|Participant Flow|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978836|NCT00870363|P2|Participant Flow|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978837|NCT00870363|P1|Participant Flow|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978838|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
978839|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978840|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978841|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978842|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
978843|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978844|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978845|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978846|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
978847|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978897|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978848|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978849|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978850|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
978851|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978852|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978853|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978854|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
978855|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978856|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978857|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978858|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
978859|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978860|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978861|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978862|NCT00870363|O4|Outcome|HIV Negative Controls Not on ART|HIV-negative
978863|NCT00870363|O3|Outcome|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978864|NCT00870363|O2|Outcome|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978898|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978865|NCT00870363|O1|Outcome|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978866|NCT00870363|E4|Reported Event|HIV Negative Controls Not on ART|HIV-negative
978867|NCT00870363|E3|Reported Event|Efavirenz or Other NNRTI With 2 NRTIs|"efavirenz or other NNRTI (non-nucleoside reverse transcriptase inhibitor) in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~efavirenz [or other NNRTI (non-nucleoside reverse transcriptase inhibitor)]: efavirenz 600mg 1 capsule is taken once a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978868|NCT00870363|E2|Reported Event|Maraviroc PLUS Raltegravir in Combination With 2 NRTIs|"maraviroc PLUS raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc plus raltegravir in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food PLUS raltegravir 400mg 1 tablet taken twice a day without regard to food in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978869|NCT00870363|E1|Reported Event|Maraviroc in Combination With 2 NRTIs|"maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician~maraviroc in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor): maraviroc 300mg 1 tablet taken twice a day without regard to food taken in combination with 2 NRTIs (dual nucleoside reverse transcriptase inhibitor) pre-determined with primary care physician"
978870|NCT00870194|B3|Baseline|Total|Total of all reporting groups
978871|NCT00870194|B2|Baseline|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978872|NCT00870194|B1|Baseline|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978873|NCT00870194|P2|Participant Flow|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978874|NCT00870194|P1|Participant Flow|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978875|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978876|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978877|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978878|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978879|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978880|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978881|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978882|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978883|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978884|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978885|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978886|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978887|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978888|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978889|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978890|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978891|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978892|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978893|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978894|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978895|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978896|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978937|NCT00869947|P1|Participant Flow|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
978899|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978900|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978901|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978902|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978903|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978904|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978905|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978906|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978907|NCT00870194|O2|Outcome|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978908|NCT00870194|O1|Outcome|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978909|NCT00870194|E2|Reported Event|Exenatide + Sitagliptin|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Sitagliptin-100mg tablet orally once a day.
978910|NCT00870194|E1|Reported Event|Exenatide + Placebo|Exenatide-subcutaneous injection, 5mcg (4 weeks) followed by 10mcg (16 weeks), twice a day; Placebo-tablet orally once a day.
978911|NCT00870103|B1|Baseline|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
978912|NCT00870103|P1|Participant Flow|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
978913|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
978914|NCT00870103|O1|Outcome|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
978915|NCT00870103|E1|Reported Event|Vigadexa Group|Vigadexa (moxifloxacin 0.5% and dexamethasone 0.1%) eye drops; 1 drop every 6 hours into the study eye
978916|NCT00869999|B1|Baseline|Treatment Arm|All patients received treatment with everolimus-rituximab on this single am study
978917|NCT00869999|P1|Participant Flow|Everolimus-Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
978918|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
978919|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
978920|NCT00869999|O1|Outcome|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
978921|NCT00869999|E1|Reported Event|Everolimus/Rituximab|All patients received treatment with everolimus-rituximab on this single am study. Everloimus was administered at a dose of 10mg by mouth once daily on days 1-28 of a 28-day cycle. Rituximab was administered at a dose of 375 mg/m3 intravenously weekly for four doses during cycle 1, and then on day 1 of cycles 2-6. After cycle 6, patients could receive an additional 6 months of everolimus monotherapy in the absence of disease progression or unacceptable toxicity.
978922|NCT00869960|B1|Baseline|Combination Antiretroviral Therapy|Single dose administration of tenofovir, emtricitabine, atazanavir and ritonavir to healthy women
978923|NCT00869960|P1|Participant Flow|Antiretroviral Therapy|Healthy volunteers
978924|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978925|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978926|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978927|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978928|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978929|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978930|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978931|NCT00869960|O1|Outcome|Antiretroviral Therapy|Healthy volunteers
978932|NCT00869960|E1|Reported Event|Antiretroviral Therapy|Healthy volunteers
978933|NCT00869947|B3|Baseline|Total|Total of all reporting groups
978934|NCT00869947|B2|Baseline|Non-amputee|Non-amputees
978935|NCT00869947|B1|Baseline|Prosthesis|Subjects with transtibial amputation using a passive ankle-foot prosthesis
978936|NCT00869947|P2|Participant Flow|Non-amputees|Non-amputees
978938|NCT00869947|O3|Outcome|Non-Amputees|
978945|NCT00869947|O2|Outcome|Participants With an Amputation Using a Powered Prosthesis|
978946|NCT00869947|O1|Outcome|Participants With an Amputation Using a Passive Prosthesis|
978947|NCT00869947|E2|Reported Event|Non-amputees|Non-amputees
978948|NCT00869947|E1|Reported Event|Prosthesis|Subjects with transtibial amputation using a powered and passive ankle-foot prosthesis
978949|NCT00869791|B1|Baseline|All Study Participants|Participants who were randomized to receive either IPX066 or IR CD-LD
978950|NCT00869791|P2|Participant Flow|IR CD-LD First ( 7 Days), Washout (7 Days) Then IPX066 (7days)|In this arm there were 2 treatment periods of one week each. During period 1, 13 subjects received 7 days of IR CD-LD first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 13 subjects received IPX066 for 7 days.
978951|NCT00869791|P1|Participant Flow|IPX066 First (7 Days), Washout (7 Days) Then IR CD-LD (7 Days)|In this arm there were 2 treatment periods of one week each. During period 1, 14 subjects received 7 days of IPX066 first. Then subjects returned to their pre-study regimen during the washout period of approximately 1 week. This was followed by Period 2. During period 2, the 14 subjects received IR CD-LD for 7 days.
978952|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
978953|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
978954|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
978955|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
978956|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
978957|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
978958|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
978959|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
978960|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
978961|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
978962|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
978963|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
978964|NCT00869791|O2|Outcome|IR CD-LD|All participants who received IR CD-LD in either study period
978965|NCT00869791|O1|Outcome|IPX066|All participants who received IPX066 in either study period
978966|NCT00869791|E2|Reported Event|CD-LD IR|All participants who received IR CD-LD in either study period
978967|NCT00869791|E1|Reported Event|IPX066|All participants who received IPX066 in either study period
978968|NCT00869778|B4|Baseline|Total|Total of all reporting groups
978969|NCT00869778|B3|Baseline|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
978970|NCT00869778|B2|Baseline|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
978971|NCT00869778|B1|Baseline|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
978972|NCT00869778|P3|Participant Flow|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978973|NCT00869778|P2|Participant Flow|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978974|NCT00869778|P1|Participant Flow|εPA-44 900μg|Subcutaneous injection of εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978975|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978976|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978977|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978978|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978979|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978980|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978981|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978982|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978983|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978984|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978985|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978986|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978987|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978988|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978989|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978990|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978991|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978992|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978993|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978994|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
981370|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
978995|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978996|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
978997|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
978998|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
978999|NCT00869778|O3|Outcome|Placebo 900μg|Participants subcutaneous injected Placebo 900μg at week 0, 4, 8, 12, 20, 28.
979000|NCT00869778|O2|Outcome|εPA-44 600μg|Participants subcutaneous injected εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.
979001|NCT00869778|O1|Outcome|εPA-44 900μg|Participants subcutaneous injected εPA-44 900μg at week 0, 4, 8, 12, 20, 28.
979002|NCT00869778|O3|Outcome|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
979003|NCT00869778|O2|Outcome|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28."
979004|NCT00869778|O1|Outcome|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 900μg/600μg at week 0, 4, 8, 12, 20, 28."
979005|NCT00869778|E3|Reported Event|Placebo 900μg|"Inject Placebo 900μg at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
979006|NCT00869778|E2|Reported Event|εPA-44 600μg+Placebo 300μg|"Inject εPA-44 600μg+Placebo 300μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28.~Placebo: Inject Placebo at week 0, 4, 8, 12, 20, 28."
979007|NCT00869778|E1|Reported Event|εPA-44 900μg|"Inject εPA-44 900μg at week 0, 4, 8, 12, 20, 28.~εPA-44: Inject εPA-44 at week 0, 4, 8, 12, 20, 28."
979008|NCT00869622|B3|Baseline|Total|Total of all reporting groups
979009|NCT00869622|B2|Baseline|Placebo Sugar Pill|Placebo participants received calcium and vitamin D supplementation in addition to a placebo tablet identical to risedronate tablet weekly
979010|NCT00869622|B1|Baseline|Risedronate|Active drug participants received calcium and vitamin D supplementation in addition to 35 mgs of risedronate tablet weekly
979011|NCT00869622|P2|Participant Flow|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
979012|NCT00869622|P1|Participant Flow|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
979013|NCT00869622|O2|Outcome|Placebo + Calcium and Vitamin D|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + Calcium and Vitamin D: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
979014|NCT00869622|O1|Outcome|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
979015|NCT00869622|O2|Outcome|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
979016|NCT00869622|O1|Outcome|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
979017|NCT00869622|E2|Reported Event|Placebo Sugar Pill|"All patients both on placebo and active bisphosphonate to receive calcium and vitamin D~Placebo + calcium and vitamin d: sugar pill + calcium 1200mgs/day and vitamin d at least 800IU"
979018|NCT00869622|E1|Reported Event|Risedronate|"Active drug~Risedronate: 35 mgs/week + calcium and vit d"
979019|NCT00869609|B3|Baseline|Total|Total of all reporting groups
979020|NCT00869609|B2|Baseline|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979021|NCT00869609|B1|Baseline|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979022|NCT00869609|P2|Participant Flow|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979023|NCT00869609|P1|Participant Flow|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979065|NCT00869557|E1|Reported Event|Stribild|Stribild and placebo to match Atripla were administered during the double-blind phase.
979024|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979025|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979026|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979027|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979028|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979029|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979030|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979031|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979032|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979066|NCT00869518|B3|Baseline|Total|Total of all reporting groups
979067|NCT00869518|B2|Baseline|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979033|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979034|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979035|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979036|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979037|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979038|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979039|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979040|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979041|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979068|NCT00869518|B1|Baseline|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979069|NCT00869518|P2|Participant Flow|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979117|NCT00869362|B1|Baseline|Diabetes Management Team|Evaluation and management by diabetes management team
979042|NCT00869609|O2|Outcome|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979043|NCT00869609|O1|Outcome|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979044|NCT00869609|E2|Reported Event|GLB-Carb-focused Maintenance (CF)|"After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information regarding healthy carbohydrate intake and hunger management.~GLB-Carb-focused Maintenance: After completion of the GLB 12 core sessions, participants will be randomly assigned to either Group Lifestyle Balance (GLB) program traditional maintenance or GLB Carb-focused maintenance. GLB-CF participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979045|NCT00869609|E1|Reported Event|GLB Traditional Maintenance (TM)|"Group Lifestyle Balance (GLB) program Traditional Maintenance. Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions.~GLB Traditional Maintenance: Group Lifestyle Balance (GLB)-Carb-focused Maintenance: Participants will attend monthly maintenance sessions to assist them in maintaining the healthy lifestyle they have adopted during the 12 Core sessions. In addition, they will receive information on healthy carbohydrate intake and hunger management."
979046|NCT00869557|B3|Baseline|Total|Total of all reporting groups
979047|NCT00869557|B2|Baseline|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979048|NCT00869557|B1|Baseline|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979049|NCT00869557|P2|Participant Flow|Atripla|Atripla (efavirenz [EFV] 150 mg/FTC 200 mg/TDF 300 mg) QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979050|NCT00869557|P1|Participant Flow|Stribild|Stribild (elvitegravir [EVG] 150 mg/GS-9350 [cobicistat; COBI] 150 mg/emtricitabine [FTC] 200 mg/tenofovir disoproxil fumarate [TDF] 300 mg) once daily (QD) and placebo to match Atripla once daily prior to bedtime (QHS) were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979051|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979052|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979053|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979054|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979055|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979056|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979057|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979058|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979059|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979060|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979061|NCT00869557|O2|Outcome|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase. Stribild QD was administered during the extension phase.
979062|NCT00869557|O1|Outcome|Stribild|Stribild QD and placebo to match Atripla QHS were administered during the double-blind phase. Stribild QD was administered during the extension phase.
979063|NCT00869557|E3|Reported Event|All Stribild|The All Stribild safety analysis set included all participants who received at least 1 dose of Stribild in the randomized phase or in the open-label extension phase. Adverse event data presented in this group include the following: Adverse events collected from participants who were initially randomized to the double-blind Stribild group while they received double-blind Stribild during the randomized phase and open-label Stribild during the extension phase; adverse events collected from the open-label Stribild extension phase only from the participants who were initially randomized to the Atripla group during the randomized phase.
979064|NCT00869557|E2|Reported Event|Atripla|Atripla QHS and placebo to match Stribild QD were administered during the double blind phase.
979070|NCT00869518|P1|Participant Flow|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979071|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979072|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979073|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979074|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979075|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979076|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979077|NCT00869518|O2|Outcome|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979078|NCT00869518|O1|Outcome|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979079|NCT00869518|E2|Reported Event|Placebo|"Subjects assigned to 7 days of treatment with placebo plus trimethoprim-sulfamethoxazole~placebo plus trimethoprim-sulfamethoxazole: placebo plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979080|NCT00869518|E1|Reported Event|Rifabutin|"Subjects assigned to 7 days of treatment with rifabutin plus trimethoprim-sulfamethoxazole~rifabutin plus trimethoprim sulfamethoxazole: rifabutin 300 mg PO daily or equivalent depending on concomitant medications plus trimethoprim-sulfamethoxazole 1 DS tab twice daily both for 7 days"
979081|NCT00869401|B4|Baseline|Total|Total of all reporting groups
979082|NCT00869401|B3|Baseline|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
979083|NCT00869401|B2|Baseline|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979084|NCT00869401|B1|Baseline|Phase I|All patients included in the Phase I portion of the study were published together for this results portion.
979085|NCT00869401|P5|Participant Flow|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
979086|NCT00869401|P4|Participant Flow|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979087|NCT00869401|P3|Participant Flow|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979088|NCT00869401|P2|Participant Flow|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
979089|NCT00869401|P1|Participant Flow|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
979090|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
979116|NCT00869362|B2|Baseline|Control|Patients receive usual care for diabetes
979091|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979092|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
979093|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979094|NCT00869401|O3|Outcome|Dose Level 1 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979095|NCT00869401|O2|Outcome|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
979096|NCT00869401|O1|Outcome|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 50 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
979097|NCT00869401|O2|Outcome|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
979098|NCT00869401|O1|Outcome|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979099|NCT00869401|E5|Reported Event|Group 1 (Phase II) Dasatinib + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Placebo 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Placebo. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Placebo 150 mg/day until progression.
979100|NCT00869401|E4|Reported Event|Group 2 (Phase II) Placebo + Radiation + Temozolomide|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979101|NCT00869401|E3|Reported Event|Dose Level 1 Phase1|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 150 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 150 mg/day until progression.
979102|NCT00869401|E2|Reported Event|Dose Level 0-A Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib100 mg/day until progression.
979103|NCT00869401|E1|Reported Event|Dose Level 0 Phase I|Cycle 1: Radiation therapy (RT) 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day and Dasatinib at 100 mg twice a day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Dasatinib. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Dasatinib 100 mg/day until progression.
979104|NCT00869375|B3|Baseline|Total|Total of all reporting groups
979105|NCT00869375|B2|Baseline|ANGIOJET GROUP|3 patients were randomized in this group
979106|NCT00869375|B1|Baseline|CLEARWAY GROUP|3 patients were randomized in this group.
979107|NCT00869375|P2|Participant Flow|ANGIOJET GROUP|3 patients were randomized in this group
979108|NCT00869375|P1|Participant Flow|CLEARWAY GROUP|3 patients were randomized in this group.
979109|NCT00869375|O2|Outcome|ANGIOJET GROUP|3 patients were randomized in this group
979110|NCT00869375|O1|Outcome|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
979111|NCT00869375|O2|Outcome|ANGIOJET GROUP|No patients had distal embolization
979112|NCT00869375|O1|Outcome|CLEARWAY GROUP|No patients had distal embolization
979113|NCT00869375|E2|Reported Event|ANGIOJET GROUP|3 patients were randomized in this group
979114|NCT00869375|E1|Reported Event|CLEARWAY GROUP|4 patients were randomized in this group. One patient was excluded since intervention was not required.
979115|NCT00869362|B3|Baseline|Total|Total of all reporting groups
979118|NCT00869362|P2|Participant Flow|Control|Patients receive usual care for diabetes
979119|NCT00869362|P1|Participant Flow|Diabetes Management Team|Evaluation and management by diabetes management team including physician and nurse practitioner CDE. Physician performed diabetes medication initiation and/or titration and nurse performed CDE focusing on Diabetes Survival Skills.
979120|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
979121|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team
979122|NCT00869362|O2|Outcome|Control|Patients receive usual care for diabetes
979123|NCT00869362|O1|Outcome|Diabetes Management Team|Evaluation and management by diabetes management team (physician, nurse practitioner CDE) with physician-initiation and titration of diabetes medication and nurse CDE education on Diabetes Survival Skills.
979124|NCT00869362|E2|Reported Event|Control|Patients receive usual care for diabetes
979125|NCT00869362|E1|Reported Event|Diabetes Management Team|Evaluation and management by diabetes management team
979126|NCT00869349|B3|Baseline|Total|Total of all reporting groups
979127|NCT00869349|B2|Baseline|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
979128|NCT00869349|B1|Baseline|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
979129|NCT00869349|P2|Participant Flow|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
979130|NCT00869349|P1|Participant Flow|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
979131|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
979132|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
979133|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
979134|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
979135|NCT00869349|O2|Outcome|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
979136|NCT00869349|O1|Outcome|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
979137|NCT00869349|E2|Reported Event|Education Group|Education: The intervention for the controls includes an initial meeting with a health professional. Once a month for 9 months, patients will received educational material and a follow-up phone call to ask if the patient received the information and to answer any questions about the material.
979138|NCT00869349|E1|Reported Event|IFS Intervention Group|"IFS: The program will begin with a half day orientation to meet the trained professional coaches and other patients enrolled in the program. Following the orientation there will be group meetings of 8-10 RA patients every other week for twelve weeks with one of the trained coaches. In the weeks patients do not meet with the group, patients will have individual coaching sessions. The group meetings will last approximately 90 minutes and the individual meetings will last 50 minutes. A maintenance program will follow with bimonthly coaching sessions and a group meeting once a month over the next six months.~Three, six and nine months after the beginning of the program, patients will return to the hospital to complete the same research questionnaire and physical examination they received at baseline."
979139|NCT00869323|B1|Baseline|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979140|NCT00869323|P1|Participant Flow|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979141|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979142|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979143|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979144|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979145|NCT00869323|O1|Outcome|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979174|NCT00869141|O1|Outcome|Hypertensive Phase Group|Eyes that developed hypertensive phase after Ahmed valve implantation
979175|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979146|NCT00869323|E1|Reported Event|Treated Study Participants|"Study participants receiving bortezomib and rituximab for post-transplant lymphoproliferative disorders (PTLD).~Induction Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 If complete response, start Maintenance Therapy. If partial response or stable disease, start Single Agent Bortezomib. If progressive disease, discontinue study treatment.~Single Agent Bortezomib bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 4, 8, 11 every 21 days for 4 cycles.~If complete response or partial response, start Maintenance Therapy. If stable disease or progressive disease, discontinue study treatment.~Maintenance Therapy:~rituximab: 375 mg/m^2 intravenously on Days 1,8, 15 and 22 bortezomib: 1.3 mg/m^2 intravenous bolus days 1, 8, 15 and 22 Repeat every 6 months for a total of 4 cycles."
979147|NCT00869258|B1|Baseline|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
979148|NCT00869258|P1|Participant Flow|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
979149|NCT00869258|O1|Outcome|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
979150|NCT00869258|E1|Reported Event|GTX and Radiation Therapy With Gemzar|Chemotherapy Treatment with Gemcitabine, Docetaxel, and Capecitabine (GTX) and weekly radiation therapy with low-dose Gemzar chemotherapy.
979151|NCT00869167|B3|Baseline|Total|Total of all reporting groups
979152|NCT00869167|B2|Baseline|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979153|NCT00869167|B1|Baseline|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979154|NCT00869167|P2|Participant Flow|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979155|NCT00869167|P1|Participant Flow|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979156|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
979157|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before bedtime
979158|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979159|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979160|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979161|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979162|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979163|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979164|NCT00869167|O2|Outcome|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979165|NCT00869167|O1|Outcome|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979166|NCT00869167|E2|Reported Event|Placebo|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979167|NCT00869167|E1|Reported Event|Ramelteon|Participants with insomnia and asthma are randomized to Ramelteon 8mg and sleep hygiene for 5 weeks or to placebo and sleep hygiene for 5 weeks. Ramelteon or placebo to be taken within 30 minutes before
979168|NCT00869141|B3|Baseline|Total|Total of all reporting groups
979169|NCT00869141|B2|Baseline|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979170|NCT00869141|B1|Baseline|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979171|NCT00869141|P2|Participant Flow|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979172|NCT00869141|P1|Participant Flow|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979173|NCT00869141|O2|Outcome|Non-hypertensive Phase Group|Eyes that did not develop hypertensive phase after Ahmed valve implantation
979176|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979177|NCT00869141|O2|Outcome|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979178|NCT00869141|O1|Outcome|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979179|NCT00869141|E2|Reported Event|Standard of Care Arm|"Receive glaucoma medication if eye pressure more than 17 mmHg after Ahmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979180|NCT00869141|E1|Reported Event|Research Arm|"Receive glaucoma medications if the eye pressure more than 10 mmHg after AHmed valve implantation~glaucoma medications (Timolol, Brimonidine, Dorzolamide, Brinzolamide): Subjects may receive glaucoma medications after Ahmed valve implantation"
979181|NCT00869128|B1|Baseline|Entire Study Population|Subjects were treated for 3 weeks with 1 tablet per night of Placebo or Circadin and then 3 weeks of Circadin or Placebo, respectively.
979182|NCT00869128|P2|Participant Flow|Circadin First|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg and then with Placebo.
979183|NCT00869128|P1|Participant Flow|Placebo First|Subjects were treated for 3 weeks with 1 tablet per night of Placebo and then with 2 mg melatonin (Circadin).
979184|NCT00869128|O2|Outcome|Circadin|Subjects were treated for 3 weeks with 1 tablet per night of Circadin 2mg
979185|NCT00869128|O1|Outcome|Placebo|Subjects were treated for 3 weeks with 1 tablet per night of Placebo
979186|NCT00869089|B1|Baseline|CC-10004|CC-10004 Treatment
979187|NCT00869089|P1|Participant Flow|CC-10004|"CC-10004 treatment:~30mg,oral medication, BID, for 24 weeks (60mg total DAILY)"
979188|NCT00869089|O1|Outcome|CC-10004|CC-10004 treatment
979189|NCT00869089|E1|Reported Event|CC-10004|CC-10004: 30mg,oral medication, BID, for 24 weeks (60mg total DAILY)
979190|NCT00869050|B1|Baseline|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
979191|NCT00869050|P1|Participant Flow|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
979192|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
979193|NCT00869050|O1|Outcome|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
979194|NCT00869050|E1|Reported Event|Capecitabine and Temozolomide|"Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).~Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.~Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).~Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles~After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle."
979195|NCT00868998|B1|Baseline|Treatment|Gemcitabine, Docetaxel, and Capecitabine
979196|NCT00868998|P1|Participant Flow|Treatment|Gemcitabine, Docetaxel, and Capecitabine
981371|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
979197|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
979198|NCT00868998|O1|Outcome|Treatment|Gemcitabine, Docetaxel, and Capecitabine
979199|NCT00868998|E1|Reported Event|Treatment|Gemcitabine, Docetaxel, and Capecitabine
979200|NCT00868959|B1|Baseline|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
979201|NCT00868959|P1|Participant Flow|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
979202|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
979203|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
979204|NCT00868959|O1|Outcome|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
979205|NCT00868959|E1|Reported Event|Lurasidone|lurasidone: Lurasidone 20-120 mg/d Flexibly Dosed - 24 weeks
979206|NCT00868790|B1|Baseline|All Randomized Participants|All randomized participants who took at least one dose of study treatment
979207|NCT00868790|P14|Participant Flow|METF→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 14)|Domiciled participants received oral treatment with metformin 1000 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to metformin for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4. Participants in this arm were administered active metformin during Period 1 and metformin placebo during Period 2.
979208|NCT00868790|P13|Participant Flow|PLA→METF→MK-3577 QD AM→MK-3577 QD PM (Arm 13)|Domiciled participants received oral treatment with dose-matched placebo to metformin (METF) for 4 weeks during Period 1, followed by metformin 1000 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Participants in this arm were administered metformin placebo during Period 1 and active metformin during Period 2.
979209|NCT00868790|P12|Participant Flow|MK-3577 BID→MK-3577 QD AM→PLA→MK-3577 QD PM (Arm 12)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
979210|NCT00868790|P11|Participant Flow|MK-3577 QD PM→PLA→MK-3577 QD AM→MK-3577 BID (Arm 11)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
979211|NCT00868790|P10|Participant Flow|MK-3577 QD AM→MK-3577 BID→MK-3577 QD PM→PLA (Arm 10)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
979212|NCT00868790|P9|Participant Flow|PLA→MK-3577 QD PM→MK-3577 BID→MK-3577 QD AM (Arm 9)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
979213|NCT00868790|P8|Participant Flow|MK-3577 BID→PLA→MK-3577 QD PM→MK-3577 QD AM (Arm 8)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
979214|NCT00868790|P7|Participant Flow|MK-3577 QD PM→MK-3577 QD AM→MK-3577 BID→PLA (Arm 7)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
979215|NCT00868790|P6|Participant Flow|MK-3577 QD AM→MK-3577 QD PM→PLA→MK-3577 BID (Arm 6)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4.
979216|NCT00868790|P5|Participant Flow|PLA→MK-3577 BID→MK-3577 QD AM→MK-3577 QD PM (Arm 5)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 25 mg BID for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4.
979217|NCT00868790|P4|Participant Flow|MK-3577 BID→MK-3577 QD PM→MK-3577 QD AM→PLA (Arm 4)|Participants received oral treatment with MK-3577 25 mg BID for 4 weeks during Period 1, followed by MK-3577 6 mg QD PM for 4 weeks during Period 2, followed by MK-3577 10 mg QD AM for 4 weeks during Period 3, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 4.
979218|NCT00868790|P3|Participant Flow|MK-3577 QD PM→MK-3577 BID→PLA→MK-3577 QD AM (Arm 3)|Participants received oral treatment with MK-3577 6 mg QD PM for 4 weeks during Period 1, followed MK- 3577 25 mg BID for 4 weeks during Period 2, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 3, followed by MK-3577 10 mg QD AM for 4 weeks during Period 4.
979219|NCT00868790|P2|Participant Flow|MK-3577 QD AM→PLA→MK-3577 BID→MK-3577 QD PM (Arm 2)|Participants received oral treatment with MK-3577 10 mg QD AM for 4 weeks during Period 1, followed by dose-matched placebo to MK-3577 for 4 weeks during Period 2, followed by MK-3577 25 mg BID for 4 weeks during Period 3, followed by MK-3577 6 mg QD PM for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
979220|NCT00868790|P1|Participant Flow|PLA→MK-3577 QD AM→MK-3577 QD PM→MK-3577 BID (Arm 1)|Participants received oral treatment with dose-matched placebo to MK-3577 for 4 weeks during Period 1, followed by MK-3577 10 mg QD AM for 4 weeks during Period 2, followed by MK-3577 6 mg QD PM for 4 weeks during Period 3, followed by MK-3577 25 mg BID for 4 weeks during Period 4. Domiciled participants also received placebo to metformin during Period 1 and Period 2.
979221|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
979222|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
979223|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
979224|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
979225|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
979226|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
979227|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
979228|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
979229|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
979230|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
979231|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
979232|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
979233|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
979234|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
979235|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
979236|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
979237|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
979238|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
979239|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
979240|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
979241|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
979242|NCT00868790|O4|Outcome|MK-3577 BID|Participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
979243|NCT00868790|O3|Outcome|MK-3577 PM|Participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
979244|NCT00868790|O2|Outcome|MK-3577 AM|Participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks.
979245|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
979246|NCT00868790|O5|Outcome|METF BID|Domiciled participants received metformin 1000 mg orally BID 4 weeks (received during Period 1 or 2 only).
979247|NCT00868790|O4|Outcome|MK-3577 BID|Domiciled participants received MK-3577 25 mg orally twice daily (BID) for 4 weeks.
979248|NCT00868790|O3|Outcome|MK-3577 PM|Domiciled participants received MK-3577 6 mg orally QD in the evening (PM) for 4 weeks.
979249|NCT00868790|O2|Outcome|MK-3577 AM|Domiciled participants received MK-3577 10 mg orally every day (QD) in the morning (AM) for 4 weeks
979250|NCT00868790|O1|Outcome|Placebo (PLA)|Participants received dose-matched placebo tablets to MK-3577 (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
979251|NCT00868790|E5|Reported Event|METF BID|Domiciled participants received metformin 1000 mg orally BID for 4 weeks (received during Period 1 or 2 only).
979252|NCT00868790|E4|Reported Event|MK-3577 BID|Participants received 25 mg MK-3577 orally BID for 4 weeks.
979253|NCT00868790|E3|Reported Event|MK-3577 PM|Participants received 6 mg MK-3577 orally QD in the PM for 4 weeks.
979254|NCT00868790|E2|Reported Event|MK-3577 AM|Participants received 10 mg MK-3577 orally QD in the AM for 4 weeks.
979255|NCT00868790|E1|Reported Event|Placebo|Participants received a placebo tablet matching the respective MK-3577 dose (10 mg, 6 mg, 25 mg) and metformin, depending upon randomization, for 4 weeks.
979256|NCT00868751|B1|Baseline|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979257|NCT00868751|P1|Participant Flow|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979258|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979297|NCT00868699|E2|Reported Event|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
979298|NCT00868699|E1|Reported Event|Placebo|Placebo : Placebo Comparator
979476|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
979259|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979260|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979261|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979262|NCT00868751|O1|Outcome|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979263|NCT00868751|E1|Reported Event|Tocilizumab|"Single arm study - treatment only~tocilizumab: Initial therapy: Tocilizumab dosed by body weight (8mg/kg based on body weight ≥ 30kg) given by intravenous infusion every two weeks for 12 weeks.~Extension of therapy: Continuation of treatment with tocilizumab at 8mg/kg by body weight given by intravenous infusion every 2 weeks based upon achievement of Primary Objective by week 12, OR continuation of treatment with escalation of tocilizumab dose to 12mg/kg by body weight, given by intravenous infusion every two weeks, for failure to achieve ACR JIA30 at 12 weeks or ACR JIA50 response at any time after week 16."
979264|NCT00868712|B4|Baseline|Total|Total of all reporting groups
979265|NCT00868712|B3|Baseline|3 - Warfarin Use Chronic|Warfarin use >24 months
979266|NCT00868712|B2|Baseline|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
979267|NCT00868712|B1|Baseline|Warfarin Use Short Duration|Warfarin use for less than 6 months
979268|NCT00868712|P3|Participant Flow|3 - Warfarin Use Chronic|Warfarin use >24 months
979269|NCT00868712|P2|Participant Flow|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
979270|NCT00868712|P1|Participant Flow|Warfarin Use Short Duration|Warfarin use for less than 6 months
979271|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
979272|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
979273|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
979274|NCT00868712|O3|Outcome|3 - Warfarin Use Chronic|Warfarin use >24 months
979275|NCT00868712|O2|Outcome|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
979276|NCT00868712|O1|Outcome|Warfarin Use Short Duration|Warfarin use for less than 6 months
979277|NCT00868712|E3|Reported Event|3 - Warfarin Use Chronic|Warfarin use >24 months
979278|NCT00868712|E2|Reported Event|2 - Warfarin Use Intermediate|Warfarin use for 6 to 24 months in duration
979279|NCT00868712|E1|Reported Event|Warfarin Use Short Duration|Warfarin use for less than 6 months
979280|NCT00868699|B4|Baseline|Total|Total of all reporting groups
979281|NCT00868699|B3|Baseline|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
979282|NCT00868699|B2|Baseline|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
979283|NCT00868699|B1|Baseline|Placebo|Placebo : Placebo Comparator
979284|NCT00868699|P3|Participant Flow|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
979285|NCT00868699|P2|Participant Flow|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
979286|NCT00868699|P1|Participant Flow|Placebo|Placebo : Placebo Comparator
979287|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
979288|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
979289|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
979290|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
979291|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
979292|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
979293|NCT00868699|O3|Outcome|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
979294|NCT00868699|O2|Outcome|Lurasidone High Arm|lurasidone : lurasidone 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6 and 80 mg/day on Day 7 and 80-120 mg/day
979295|NCT00868699|O1|Outcome|Placebo|Placebo : Placebo Comparator
979296|NCT00868699|E3|Reported Event|Lurasidone Low Arm|lurasidone : lurasidone 20 mg/day for Days 1-7, beginning day 8 flexibly dosed 20-60 mg/day
979299|NCT00868530|B1|Baseline|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979300|NCT00868530|P1|Participant Flow|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979301|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979302|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979303|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979304|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979305|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979306|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979307|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979308|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979309|NCT00868530|O1|Outcome|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979310|NCT00868530|E1|Reported Event|Xyntha|Participants received on-demand treatments with Xyntha (which occurred each time a participant experienced bleeding episode during the active phase of the study) according to investigator’s prescription over a 6-month (calendar day) period. A single 50 International Unit (IU)/kg (+/-5 IU/kg) intravenous (IV) bolus infusion of Xyntha was given for recovery assessments.
979311|NCT00868517|B4|Baseline|Total|Total of all reporting groups
979312|NCT00868517|B3|Baseline|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979313|NCT00868517|B2|Baseline|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
979314|NCT00868517|B1|Baseline|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979315|NCT00868517|P3|Participant Flow|Wait-List Control Group|Served as wait-list control group. Did not receive any type of group ear acupuncture intervention--served as strict control and received conventional care only. Eligible to receive true group auricular acupuncture once study period was completed.
979316|NCT00868517|P2|Participant Flow|Sham Group Auricular Acupuncture|Received sham group auricular acupuncture.
979317|NCT00868517|P1|Participant Flow|True Group Auricular Acupuncture|Received true group auricular acupuncture.
979318|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979319|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
979320|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979321|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979322|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
981372|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
979323|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979324|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979325|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
979326|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979327|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979328|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
979329|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979330|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979331|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
979332|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979333|NCT00868517|O3|Outcome|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979334|NCT00868517|O2|Outcome|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
979335|NCT00868517|O1|Outcome|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979336|NCT00868517|E3|Reported Event|Wait List Control Group|"Served as wait list control. Did not receive any acupuncture during the study period.~Wait-List Control Group: Received conventional care only. Eligible to receive true group auricular acupuncture once study period completed."
979337|NCT00868517|E2|Reported Event|Sham Group Auricular Acupuncture|"Received sham group auricular acupuncture~Sham group auricular acupuncture: Received sham auricular acupuncture."
979338|NCT00868517|E1|Reported Event|True Group Auricular Acupuncture|"Received true group auricular acupuncture.~True group auricular acupuncture: Received true group auricular acupuncture"
979339|NCT00868452|B3|Baseline|Total|Total of all reporting groups
979340|NCT00868452|B2|Baseline|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
979341|NCT00868452|B1|Baseline|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
979342|NCT00868452|P2|Participant Flow|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
979343|NCT00868452|P1|Participant Flow|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
979344|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
979345|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
979346|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
979347|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
979348|NCT00868452|O2|Outcome|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
979349|NCT00868452|O1|Outcome|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
979350|NCT00868452|E2|Reported Event|Placebo|Placebo + (lithium or divalproex) : 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7
979351|NCT00868452|E1|Reported Event|Lurasidone|lurasidone + (lithium or divalproex) : lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7.
979352|NCT00868439|B3|Baseline|Total|Total of all reporting groups
979353|NCT00868439|B2|Baseline|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979354|NCT00868439|B1|Baseline|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979396|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979477|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
979355|NCT00868439|P2|Participant Flow|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979356|NCT00868439|P1|Participant Flow|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979357|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979358|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979359|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979360|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979361|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979362|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979363|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979364|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979365|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979366|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979367|NCT00868439|O2|Outcome|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant’s serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979368|NCT00868439|O1|Outcome|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant’s serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979369|NCT00868439|E2|Reported Event|Placebo|"Spironolactone + Placebo~Participants received placebo (twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979370|NCT00868439|E1|Reported Event|Patiromer|"Spironolactone + Patiromer~Participants received patiromer (15 g twice daily [BID]).~Participants also started spironolactone at a dose of 25 mg/day, which was increased to 50 mg/day after 2 weeks if the participant's serum potassium (based on local laboratory determination) was > 3.5 mEq/L and ≤ 5.1 mEq/L. The spironolactone dose remained at 25 mg/day if the serum potassium was > 5.1 mEq/L and ≤ 5.5 mEq/L. If, at any time, a participant's serum potassium level was confirmed to be ≤ 3.5 mEq/L or > 5.5 mEq/L based on local laboratory data, the participant was to be discontinued from the study."
979371|NCT00868374|B3|Baseline|Total|Total of all reporting groups
979372|NCT00868374|B2|Baseline|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979373|NCT00868374|B1|Baseline|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979374|NCT00868374|P2|Participant Flow|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979375|NCT00868374|P1|Participant Flow|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979376|NCT00868374|O2|Outcome|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979377|NCT00868374|O1|Outcome|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979378|NCT00868374|E2|Reported Event|Placebo|Placebo : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979379|NCT00868374|E1|Reported Event|Quetiapine XR|Quetiapine XR : Days 1-14 - 50 mg/day; Days 14-21 - 100mg/day; Day 21-End of Study - 150mg/day
979380|NCT00868348|B3|Baseline|Total|Total of all reporting groups
979381|NCT00868348|B2|Baseline|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979382|NCT00868348|B1|Baseline|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979383|NCT00868348|P2|Participant Flow|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979384|NCT00868348|P1|Participant Flow|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979385|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979386|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979387|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979388|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979389|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979390|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979391|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979392|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979393|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979394|NCT00868348|O1|Outcome|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979395|NCT00868348|O2|Outcome|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979397|NCT00868348|E2|Reported Event|Ketorolac|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and ketorolac 30 mg) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with 15 mg ketorolac
979398|NCT00868348|E1|Reported Event|Control|Intraoperative local infiltration analgesia (ropivacaine 300 mg, epinephrine 0.5 mg and saline) After surgery,eight intra-articular bolus doses of ropivacaine 100 mg with saline
979399|NCT00868309|B3|Baseline|Total|Total of all reporting groups
979400|NCT00868309|B2|Baseline|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
979401|NCT00868309|B1|Baseline|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
979402|NCT00868309|P2|Participant Flow|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
979403|NCT00868309|P1|Participant Flow|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
979404|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
979405|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
979406|NCT00868309|O2|Outcome|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
979407|NCT00868309|O1|Outcome|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
979408|NCT00868309|E2|Reported Event|CroFab Crotalidae Polyvalent Immune Fab, Ovine Antivenom|CroFab, 5 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 2 vials every 6 hrs
979409|NCT00868309|E1|Reported Event|Anavip Crotalinae (Pit Viper) Equine Immune F(ab)2 Antivenom|Anavip, 10 vials IV every 2 hours until initial control has been achieved; then 3 maintenance doses of 4 vials every 6 hrs
979410|NCT00868296|B3|Baseline|Total|Total of all reporting groups
979411|NCT00868296|B2|Baseline|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
979412|NCT00868296|B1|Baseline|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
979413|NCT00868296|P2|Participant Flow|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
979414|NCT00868296|P1|Participant Flow|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
979415|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
979416|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
979472|NCT00868218|P4|Participant Flow|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979417|NCT00868296|O2|Outcome|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
979418|NCT00868296|O1|Outcome|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
979419|NCT00868296|E2|Reported Event|High Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms.) All patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) received 2.5 mg (or higher, if the dose was increased at the start of this open label extension study to manage clinical symptoms) and were classified as part of the high dose group for analysis purposes.
979420|NCT00868296|E1|Reported Event|Low Dose Pantoprazole|Patients who participated previously in study 3001B3-333 (NCT00259012) (infants) and weighed 2.5 to <7 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg; those weighing ≥ 7 kg to ≤ 15 kg generally received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. (A patient's dose may have been increased from the dose used in the previous study at the start of this open label extension study to manage clinical symptoms) No patients who participated previously in study 3001B3-331 (NCT00362609) (pre-term/neonates) were included in the low dose group.
979421|NCT00868231|B1|Baseline|Overall Study Population|All patients randomized into the crossover study
979422|NCT00868231|P6|Participant Flow|Placebo - Tiotropium 18 μg - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler at in the evening for 15 consecutive days."
979423|NCT00868231|P5|Participant Flow|Placebo - Aclidinium 400 μg BID - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
979424|NCT00868231|P4|Participant Flow|Tiotropium 18 μg - Placebo - Aclidinium 400 μg BID|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the evening and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
979425|NCT00868231|P3|Participant Flow|Tiotropium 18 μg - Aclidinium 400 μg BID - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
979473|NCT00868218|P3|Participant Flow|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979474|NCT00868218|P2|Participant Flow|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979475|NCT00868218|P1|Participant Flow|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
979426|NCT00868231|P2|Participant Flow|Aclidinium 400 μg BID - Tiotropium 18 μg - Placebo|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
979427|NCT00868231|P1|Participant Flow|Aclidinium 400 μg BID - Placebo - Tiotropium 18 μg|"The study consisted of 3 periods of 15 treatment days each separated by a washout period of 9 to 15 days.~In treatment period 1, patients received 1 puff of aclidinium bromide from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of aclidinium bromide from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 2, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of placebo from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days.~In treatment period 3, patients received 1 puff of placebo from the Eklira Genuair® inhaler and 1 puff of tiotropium from the Handihaler® inhaler in the morning and 1 puff of placebo from the Eklira Genuair® inhaler in the evening for 15 consecutive days."
979428|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979429|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979430|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979431|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979432|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979433|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979434|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979435|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979436|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979437|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979438|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979439|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979440|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979441|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979442|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979443|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979444|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979445|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979446|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979447|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979448|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979449|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979450|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979451|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979452|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979453|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979454|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979455|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979456|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979457|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979458|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979459|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979460|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979461|NCT00868231|O3|Outcome|Placebo|Placebo via inhalation
979462|NCT00868231|O2|Outcome|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979463|NCT00868231|O1|Outcome|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979464|NCT00868231|E3|Reported Event|Placebo|Placebo via inhalation
979465|NCT00868231|E2|Reported Event|Tiotropium 18 μg Once-daily|Tiotropium 18 μg once-daily by inhalation
979466|NCT00868231|E1|Reported Event|Aclidininum Bromide 400 μg Bid|Aclidinium bromide 400 μg twice-daily via inhalation
979467|NCT00868218|B5|Baseline|Total|Total of all reporting groups
979468|NCT00868218|B4|Baseline|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979469|NCT00868218|B3|Baseline|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979470|NCT00868218|B2|Baseline|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979471|NCT00868218|B1|Baseline|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979478|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
979479|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
979480|NCT00868218|O4|Outcome|30µg HA Adjuvanted|30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
979481|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
979482|NCT00868218|O2|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered
979483|NCT00868218|O1|Outcome|1.5µg HA Adjuvanted|1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered
979484|NCT00868218|O4|Outcome|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979485|NCT00868218|O3|Outcome|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979486|NCT00868218|O2|Outcome|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979487|NCT00868218|O1|Outcome|30µg HA Vaccine|30µg HA vaccine Intramuscularly administered Influenza vaccine: Influenza virus strain: avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14
979488|NCT00868218|E4|Reported Event|30µg HA Adjuvanted|"30µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979489|NCT00868218|E3|Reported Event|7.5µg HA Adjuvanted|"7.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979490|NCT00868218|E2|Reported Event|1.5µg HA Adjuvanted|"1.5µg HA adjuvanted with 50µg 3rd generation ISCOM™ Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979491|NCT00868218|E1|Reported Event|30µg HA Vaccine|"30µg HA vaccine Intramuscularly administered~Influenza vaccine: Influenza virus strain:~avian influenza Influenza A/Vietnam/1194/2004 NIBRG-14"
979492|NCT00868192|B1|Baseline|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979493|NCT00868192|P1|Participant Flow|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979494|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979495|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979496|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979497|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979498|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979499|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979500|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979501|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979502|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979503|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979504|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979505|NCT00868192|O1|Outcome|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979506|NCT00868192|E1|Reported Event|Pemetrexed and Bevacizumab|"Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle~Bevacizumab 15 mg/kg IV on Day 1 of each 21 day cycle"
979507|NCT00868140|B3|Baseline|Total|Total of all reporting groups
979508|NCT00868140|B2|Baseline|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
979509|NCT00868140|B1|Baseline|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
979510|NCT00868140|P2|Participant Flow|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
979511|NCT00868140|P1|Participant Flow|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
979512|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
979513|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
979514|NCT00868140|O2|Outcome|2/Placebo|"Placebo control to arm 1~Placebo: placebo daily"
979515|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone treated subjects~pioglitazone: pioglitazone 45 mg"
979516|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
979517|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
979518|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
979519|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
979520|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
979521|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
979522|NCT00868140|O2|Outcome|2/Placebo|"control to arm 1~Placebo: placebo daily"
979523|NCT00868140|O1|Outcome|1/Pioglitazaone Treated|"Pioglitazone~pioglitazone: pioglitazone 45 mg"
979524|NCT00868140|E2|Reported Event|2/Placebo|"Placebo control to arm 1 in pill form identical to treatment form also twice per day for 6 months~Placebo: placebo daily"
979525|NCT00868140|E1|Reported Event|1/Pioglitazone|"Pioglitazone in pill form at 45mg twice per day for 6 months~pioglitazone: pioglitazone 45 mg"
979526|NCT00868101|B3|Baseline|Total|Total of all reporting groups
979527|NCT00868101|B2|Baseline|Control|Children who did not receive the preconditioning stimulus
979528|NCT00868101|B1|Baseline|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
979529|NCT00868101|P2|Participant Flow|Control|Children who did not receive the preconditioning stimulus
979530|NCT00868101|P1|Participant Flow|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
979531|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
979532|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
979533|NCT00868101|O2|Outcome|Control|Children that don´t received the preconditioning stimmulus
979534|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus
979535|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
979536|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
979537|NCT00868101|O2|Outcome|Control|Children who did not receive the preconditioning stimulus
979538|NCT00868101|O1|Outcome|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
979539|NCT00868101|E2|Reported Event|Control|Children who did not receive the preconditioning stimulus
979540|NCT00868101|E1|Reported Event|Preconditioning|Children who received the preconditioning stimulus:submitted to four periods of five minutes of lower limb ischemia by using a blood pressure cuff intercalated with periods of five minutes of reperfusion, the day prior to cardiac surgery. We used the patient sistolic blood pressure plus 15 mmHg to promote de preconditioning stimulus.
979541|NCT00867659|B1|Baseline|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
979542|NCT00867659|P1|Participant Flow|Cetrotide Acetate|oocyte donors will receive 3 mg cetrotide acetate by a single injection on the day of oocyte retrieval. The incidence of OHSS will be assessed.
979543|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
979544|NCT00867659|O1|Outcome|Cetrotide Acetate|oocyte donors will receive a single injection of 3 mg cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
979545|NCT00867659|E1|Reported Event|Cetrotide Acetate|oocyte donors will receive cetrotide acetate on the day of oocyte retrieval. The incidence of OHSS will be assessed.
979546|NCT00867568|B1|Baseline|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979547|NCT00867568|P1|Participant Flow|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979548|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979549|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979550|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979551|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979625|NCT00867165|B1|Baseline|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979626|NCT00867165|P2|Participant Flow|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979627|NCT00867165|P1|Participant Flow|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979552|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979553|NCT00867568|O1|Outcome|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979554|NCT00867568|E1|Reported Event|TPI 287|TPI 287: Three patients will be enrolled to receive single agent TPI 287 IV administered on Days 1, 8 and 15 of the first and second 28-day cycle. The starting dose of 90 mg/m2 (Dose Level 1) is 75% of the established adult MTD for this schedule in adults, which is 125 mg/m2. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
979555|NCT00867529|B1|Baseline|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
979556|NCT00867529|P1|Participant Flow|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
979557|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
979558|NCT00867529|O1|Outcome|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
979559|NCT00867529|E1|Reported Event|Treatment (Rituximab Pre- and Post-transplant)|"Patients receive rituximab IV, pre- and post-transplant, on days -3, 10, 24, and 38. Patients undergo donor peripheral blood stem cell transplant on day 0. Treatment continues in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV~peripheral blood stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~nonmyeloablative allogeneic hematopoietic stem cell transplantation: Undergo nonmyeloablative allogeneic peripheral blood/hematopoietic stem cell transplantation~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
979560|NCT00867503|B1|Baseline|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
979561|NCT00867503|P1|Participant Flow|Bendamustine|Bendamustine Hydrochloride (HCL) 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
979562|NCT00867503|O1|Outcome|Median Overall Survival in Days|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
979563|NCT00867503|O1|Outcome|Bendamustine Grade 4 Toxicity|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
979564|NCT00867503|O1|Outcome|Bendamustine Median Progression Free Surivial in Months|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
979565|NCT00867503|E1|Reported Event|Bendamustine|bendamustine HCL 90 mg/m2 intravenously on days 1(± 1 day) and 2 (± 1 day) every 28 days. If no grade ≥3 hematologic adverse event appears the dose will be escalated to 120 mg/m2 on days 1(± 1 day) and 2 (± 1 day) every 28 days at cycle 2.
979566|NCT00867490|B1|Baseline|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
979628|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979629|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979567|NCT00867490|P1|Participant Flow|Candesartan+HCTZ, Aliskiren+HCTZ, Aliskiren+HCTZ+Amlodipine|4 weeks treatment with candesartan 32 mg plus hydrochlorothiazide (HCTZ) 25 mg (Phase 1) followed by 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg (Phase 2) in patients with uncontrolled diastolic blood pressure (BP) in Phase 1 followed by (optional) 4 weeks treatment with aliskiren 300 mg plus HCTZ 25 mg plus amlodipine 5 mg (Phase 3) in patients with uncontrolled systolic or diastolic BP in Phase 2.
979568|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
979569|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
979570|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
979571|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
979572|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
979573|NCT00867490|O1|Outcome|Phase III - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet.
979574|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
979575|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
979576|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
979577|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
979578|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
979579|NCT00867490|O1|Outcome|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
979580|NCT00867490|E3|Reported Event|Phase 3 - Aliskiren+HCTZ+Amlodipine|The first 60 patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mm Hg and/or msSBP ≥ 140 mm Hg) at the end of Phase 2 were offered a 4 week treatment extension with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet plus amlodipine 5 mg tablet taken orally with water in the morning between 7 and 10 am.
979581|NCT00867490|E2|Reported Event|Phase 2 - Aliskiren+HCTZ|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mm Hg) at the end of Phase 1 were treated for 4 weeks with aliskiren 300 mg plus hydrochlorothiazide (HCTZ) 25 mg in a single tablet taken orally with water in the morning between 7 and 10 am.
979582|NCT00867490|E1|Reported Event|Phase 1 - Candesartan+HCTZ|4 weeks treatment with candesartan 32 mg (two 16 mg tablets) plus hydrochlorothiazide (HCTZ) 25 mg (two 12.5 mg tablets) taken orally with water in the morning between 7 and 10 am.
979583|NCT00867451|B3|Baseline|Total|Total of all reporting groups
979584|NCT00867451|B2|Baseline|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
979585|NCT00867451|B1|Baseline|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
979630|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979631|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979632|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979633|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979586|NCT00867451|P2|Participant Flow|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
979587|NCT00867451|P1|Participant Flow|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
979588|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
979589|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
979590|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delays treatment participants).
979591|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delays treatment participants).
979592|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
979593|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
979594|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed treatment participants).
979595|NCT00867451|O1|Outcome|Baseline Assessment|Results based on all participants (i.e., immediate and delayed treatment participants).
979596|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
979597|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
979598|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
979599|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
979600|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
979601|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
979602|NCT00867451|O2|Outcome|Week 5|Results based on all participants (i.e., immediate and delayed-treatment participants).
979603|NCT00867451|O1|Outcome|Baseline|Results based on all participants (i.e., immediate and delayed-treatment participants).
979604|NCT00867451|E2|Reported Event|Delayed Treatment|Pre-intervention data was collected for four weeks, after which children received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants in the delayed treatment group progressed to the melatonin phase of the intervention.
979605|NCT00867451|E1|Reported Event|Immediate Treatment|Children immediately received behavioral sleep interventions (following a structured pre-bedtime routine protocol, incorporating a white noise machine during sleep) for two weeks. If sleep parameters did improve (80% from baseline), melatonin (3mg, administered orally 1 hour prior to bedtime) supplemented the behavioral sleep treatments, for two weeks. None of the participants improved their sleep by 80% from baseline using the behavioral treatments. Thus, all participants progressed to the melatonin phase of the intervention.
979606|NCT00867360|B3|Baseline|Total|Total of all reporting groups
979607|NCT00867360|B2|Baseline|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
979608|NCT00867360|B1|Baseline|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
979609|NCT00867360|P2|Participant Flow|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
979610|NCT00867360|P1|Participant Flow|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
979611|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
979612|NCT00867360|O1|Outcome|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
979613|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
979614|NCT00867360|O1|Outcome|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
979615|NCT00867360|O2|Outcome|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
979616|NCT00867360|O1|Outcome|Mifepristone|"Receive 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
979617|NCT00867360|E2|Reported Event|Placebo|"Receive placebo rather than mifepristone~Placebo: Placebo medication"
979618|NCT00867360|E1|Reported Event|Mifepristone|"Receive 600 or 1200 mg/ day of mifepristone for 8 days~Mifepristone (RU-486)"
979619|NCT00866177|B1|Baseline|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
979620|NCT00866177|P1|Participant Flow|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
979621|NCT00866177|O1|Outcome|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
979622|NCT00866177|E1|Reported Event|AZD6244|Patients receive oral MEK inhibitor AZD6244 twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
979623|NCT00867165|B3|Baseline|Total|Total of all reporting groups
979624|NCT00867165|B2|Baseline|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979634|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979635|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979636|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979637|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979638|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979639|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979640|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979641|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979642|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979643|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979644|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979645|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979646|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979647|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979648|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979649|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979650|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979651|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979652|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979653|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979654|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979655|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979656|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979657|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979658|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979659|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979660|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979661|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979662|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979663|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979664|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979665|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979666|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979667|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979668|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979669|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979670|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979671|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979672|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979673|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979674|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979675|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979676|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979677|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979678|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979679|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979680|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979681|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979682|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979683|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979684|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979685|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979686|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979687|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979688|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979689|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979690|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979691|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979692|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979693|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979694|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979695|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979696|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979697|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979698|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
981373|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
979699|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979700|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979701|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979702|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979703|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979704|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979705|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979706|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979707|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979708|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979709|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979710|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979711|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979712|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979713|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979714|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979715|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979716|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979717|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979718|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979719|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979720|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979721|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979722|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979723|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979724|NCT00867165|O2|Outcome|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979725|NCT00867165|O1|Outcome|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979726|NCT00867165|E2|Reported Event|Placebo|Placebo to match ezetimibe 10-mg tablet once daily for 12 weeks
979727|NCT00867165|E1|Reported Event|Ezetimibe|Ezetimibe 10-mg tablet once daily for 12 weeks
979728|NCT00867139|B4|Baseline|Total|Total of all reporting groups
979729|NCT00867139|B3|Baseline|Open-Labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received open-label TCAD.
979730|NCT00867139|B2|Baseline|Neuraminidase Inhibitor Monotheraphy|Neuraminidase inhibitors include zanamivir and oseltamivir phosphate in this study.
979731|NCT00867139|B1|Baseline|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
979732|NCT00867139|P3|Participant Flow|Open-labeled TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
979733|NCT00867139|P2|Participant Flow|Neuraminidase Inhibitor Monotherapy|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
979734|NCT00867139|P1|Participant Flow|TCAD|This substudy was a randomized study comparing a triple combination antiviral drug (TCAD) therapy and oseltamivir (OSL) monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
979735|NCT00867139|O3|Outcome|Open-lable TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979736|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979737|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979738|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979739|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979740|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receiveTCAD or neuraminidase inhibitor monotherapy.
979741|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979742|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979743|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979951|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979744|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979745|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979746|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979747|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979748|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979749|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979750|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979751|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979752|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979753|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979754|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979755|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979756|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979757|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979758|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979759|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979760|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979761|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979762|NCT00867139|O3|Outcome|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979763|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979764|NCT00867139|O1|Outcome|TCAD|This substudy was a randomized study comparing TCAD therapy and OSL monotherapy in immunocompromised patients with upper respiratory tract infection due to influenza A who were over 7 years of age and who were not asthmatic.
979765|NCT00867139|O3|Outcome|Open-label TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979766|NCT00867139|O2|Outcome|Neuraminidase Inhibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979767|NCT00867139|O1|Outcome|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979768|NCT00867139|O3|Outcome|Open-labeled TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
979769|NCT00867139|O2|Outcome|Neuraminidase Inihibitor Monotherapy|oseltamivir (50 mg); three times a day for 10 days
979770|NCT00867139|O1|Outcome|TCAD|amantadine (75 mg), oseltamivir (50 mg), and ribavirin (200 mg); three times a day for 10 days
979771|NCT00867139|E3|Reported Event|Open-labeled TCAD|Subjects with moderate respiratory symptoms and/or influenza-related lower respiratory tract disease, subjects who could not tolerate zanamivir, and children aged 1-6 years received.
979772|NCT00867139|E2|Reported Event|Neuraminidase Inihibitor Monotherapy|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979773|NCT00867139|E1|Reported Event|TCAD|Eligible immunocompromised subjects( age>6 years) positively diagnosed with influenza A who had mild respiratory symptoms were randomized to receive TCAD or neuraminidase inhibitor monotherapy.
979774|NCT00867035|B3|Baseline|Total|Total of all reporting groups
979775|NCT00867035|B2|Baseline|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979776|NCT00867035|B1|Baseline|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979777|NCT00867035|P2|Participant Flow|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979778|NCT00867035|P1|Participant Flow|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979779|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979780|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979781|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979782|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979783|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979784|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979785|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979786|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979787|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979788|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979789|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979790|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979791|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979792|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979793|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979794|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979795|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979796|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979797|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979798|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979799|NCT00867035|O2|Outcome|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979800|NCT00867035|O1|Outcome|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979801|NCT00867035|E2|Reported Event|Chlorhexidene Rinse and Tongue Scraper|20ml of 0.12% chlorhexidine gluconate mouthrinse is used after tongue scraping twice a day
979802|NCT00867035|E1|Reported Event|Chlorine Dioxide Rinse and Tongue Scraper|20ml of a stabilized 0.1% chlorine dioxide mouthrinse is used after use of tongue scraper twice a day
979803|NCT00867009|B1|Baseline|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
979804|NCT00867009|P1|Participant Flow|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
979805|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
979806|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
979847|NCT00866788|P1|Participant Flow|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
980197|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
979807|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
979808|NCT00867009|O1|Outcome|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
979809|NCT00867009|E1|Reported Event|Pem/Cis + Cet|"Induction Therapy: 500 mg/m² pemetrexed (Pem)on Day 1 of every 21-day cycle, 75 mg/m² cisplatin (Cis) on Day 1 of every 21-day cycle and 400 mg/m² cetuximab (Cet) given intravenously (IV) on Day 1 of Cycle 1 and 250 mg/m² once weekly thereafter. Induction period is 4 to 6 cycles.~Maintenance Therapy: 500 mg/m² pemetrexed (Pem) given intravenously (IV) on Day 1 of each 21 day cycle and 250 mg/m² cetuximab (Cet) given weekly until progressive disease (PD) or treatment discontinuation."
979810|NCT00866918|B3|Baseline|Total|Total of all reporting groups
979811|NCT00866918|B2|Baseline|High Risk|WBC>=10,000/MicroLiter
979812|NCT00866918|B1|Baseline|Standard Risk|WBC<10,000/MicroLiter
979813|NCT00866918|P2|Participant Flow|High Risk|WBC>=10,000/MicroLiter
979814|NCT00866918|P1|Participant Flow|Standard Risk|WBC<10,000/MicroLiter
979815|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
979816|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
979817|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
979818|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
979819|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
979820|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
979821|NCT00866918|O2|Outcome|High Risk|WBC>=10,000/MicroLiter
979822|NCT00866918|O1|Outcome|Standard Risk|WBC<10,000/MicroLiter
979823|NCT00866918|E2|Reported Event|High Risk|WBC>=10,000/MicroLiter
979824|NCT00866918|E1|Reported Event|Standard Risk|WBC<10,000/MicroLiter
979825|NCT00866905|B1|Baseline|Arm/Group 1|
979826|NCT00866905|P1|Participant Flow|Ixabepilone/Cyclophosphamide|"Ixabepilone: 40 mg/m2 via intraveous (IV) infusion over 3 hours~Cyclophosphamide: 600 mg/m2 via IV infusion per institutional guidelines"
979827|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
979828|NCT00866905|O1|Outcome|Ixabepilone/Cyclophosphamide|Systemic Therapy followed by surgery and possible radiation therapy
979829|NCT00866905|E1|Reported Event|Ixabepilone/Cyclophosphamide|
979830|NCT00866814|B1|Baseline|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979831|NCT00866814|P1|Participant Flow|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979832|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979833|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979834|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979835|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979836|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979837|NCT00866814|O1|Outcome|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979838|NCT00866814|E1|Reported Event|Ventrio Group|Patients diagnosed with a ventral hernia requiring an open surgery for repair.
979839|NCT00866788|B5|Baseline|Total|Total of all reporting groups
979840|NCT00866788|B4|Baseline|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979841|NCT00866788|B3|Baseline|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979842|NCT00866788|B2|Baseline|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979843|NCT00866788|B1|Baseline|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979844|NCT00866788|P4|Participant Flow|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979845|NCT00866788|P3|Participant Flow|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979846|NCT00866788|P2|Participant Flow|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979848|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979849|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979850|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979851|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979852|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979853|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979854|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979855|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979856|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979857|NCT00866788|O3|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979858|NCT00866788|O2|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979859|NCT00866788|O1|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979860|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979861|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979862|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979863|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979864|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979865|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979866|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979867|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
980198|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
979868|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979869|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979870|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979871|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979872|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979873|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979874|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979875|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979876|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979877|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979878|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979879|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979880|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979881|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979882|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979883|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979884|NCT00866788|O4|Outcome|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979885|NCT00866788|O3|Outcome|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979886|NCT00866788|O2|Outcome|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979887|NCT00866788|O1|Outcome|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979949|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979888|NCT00866788|E4|Reported Event|Omalizumab 600 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979889|NCT00866788|E3|Reported Event|Omalizumab 300 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU)H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979890|NCT00866788|E2|Reported Event|Omalizumab 75 mg|Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979891|NCT00866788|E1|Reported Event|Placebo|Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
979892|NCT00866775|B3|Baseline|Total|Total of all reporting groups
979893|NCT00866775|B2|Baseline|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979894|NCT00866775|B1|Baseline|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979895|NCT00866775|P2|Participant Flow|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979896|NCT00866775|P1|Participant Flow|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979897|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979898|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979899|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979900|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979901|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979902|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979903|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine acetate will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979904|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine acetate will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979905|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979906|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979907|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979908|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979909|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979910|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979911|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979912|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979913|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979950|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979914|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979915|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979916|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979917|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979918|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979919|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979920|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979921|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979922|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979923|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979924|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979925|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979926|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979927|NCT00866775|O2|Outcome|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979928|NCT00866775|O1|Outcome|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979929|NCT00866775|E2|Reported Event|Eslicarbazepine 1600 mg QD|Subjects randomized to 1600 mg QD of eslicarbazepine will titrate from 600 mg (Week 1) to 1200 mg (Week 2) to 1600 mg (Weeks 3-18) QD and taper down from 1600 mg to 800 mg QD 3 days after the end of Week 18.
979930|NCT00866775|E1|Reported Event|Eslicarbazepine 1200 mg QD|Subjects randomized to 1200 mg QD eslicarbazepine will titrate from 400 mg (Week 1) to 800 mg (Week 2) to 1200 mg (Weeks 3-18) QD and taper down from 1200 mg to 600 mg QD 3 days after the end of Week 18.
979931|NCT00866723|B1|Baseline|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
979932|NCT00866723|P1|Participant Flow|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
979933|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
979934|NCT00866723|O1|Outcome|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
979935|NCT00866723|E1|Reported Event|Bevacizumab|Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
979936|NCT00866697|B3|Baseline|Total|Total of all reporting groups
979937|NCT00866697|B2|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979938|NCT00866697|B1|Baseline|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979939|NCT00866697|P2|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979940|NCT00866697|P1|Participant Flow|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979941|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979942|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979943|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979944|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979945|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979946|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979947|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979948|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979952|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979953|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979954|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979955|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979956|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979957|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979958|NCT00866697|O1|Outcome|Placebo|Placebo
979959|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979960|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979961|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979962|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979963|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979964|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979965|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979966|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979967|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979968|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979969|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979970|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979971|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979972|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979973|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979974|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979975|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979976|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979977|NCT00866697|O2|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979978|NCT00866697|O1|Outcome|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979979|NCT00866697|E2|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily for a maximum of 24 months.
979980|NCT00866697|E1|Reported Event|Placebo|Participants received matching placebo once daily for a maximum of 24 months.
979981|NCT00866658|B3|Baseline|Total|Total of all reporting groups
979982|NCT00866658|B2|Baseline|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
979983|NCT00866658|B1|Baseline|Placebo|2-step initiation regimen of volume matching placebo: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
979984|NCT00866658|P2|Participant Flow|Lixisenatide|2-step initiation regimen of lixisenatide: 10 mcg QD subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
979985|NCT00866658|P1|Participant Flow|Placebo|2-step initiation regimen of volume matching placebo: 10 microgram (mcg) once daily (QD) subcutaneously for 1 week, followed by 15 mcg QD for 1 week, then 20 mcg QD up to Week 24.
979986|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
979987|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
979988|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
979989|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
979990|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
979991|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
979992|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
979993|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
979994|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
979995|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
979996|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
979997|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
979998|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
979999|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
980000|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
980001|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
980002|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
980274|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
980003|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
980004|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
980005|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
980006|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
980007|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
980008|NCT00866658|O2|Outcome|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
980009|NCT00866658|O1|Outcome|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
980010|NCT00866658|E2|Reported Event|Lixisenatide|2-step initiation regimen up to a maintenance dose of 20 mcg of lixisenatide.
980011|NCT00866658|E1|Reported Event|Placebo|2-step initiation regimen up to a maintenance dose of 20 mcg of volume matching placebo.
980012|NCT00866606|B1|Baseline|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980013|NCT00866606|P1|Participant Flow|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980014|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980015|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980016|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980017|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980018|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980019|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980020|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980021|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980022|NCT00866606|O1|Outcome|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980023|NCT00866606|E1|Reported Event|BeneFactor IX (BeneFIX)|Participants received on-demand treatments with BeneFIX according to investigator’s prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).
980024|NCT00866359|B3|Baseline|Total|Total of all reporting groups
980025|NCT00866359|B2|Baseline|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980026|NCT00866359|B1|Baseline|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
980027|NCT00866359|P4|Participant Flow|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast BID tablets in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
980028|NCT00866359|P3|Participant Flow|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
980029|NCT00866359|P2|Participant Flow|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980030|NCT00866359|P1|Participant Flow|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
980031|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980032|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980033|NCT00866359|O2|Outcome|Apremilast 30 mg/Apremilast 30mg BID|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980034|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980035|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980036|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980037|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980038|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980039|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980040|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980041|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|"Treatment Phase (Days 1 to 85): Participants administered 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.~Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980042|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|"Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.~Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.~Day 197 includes those who entered the follow-up phase from both the placebo controlled or extension phase."
980043|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Treatment and Extension Phases (Days 1 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
980044|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
980045|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID were titrated to 30 mg apremilast tablets BID up to Day 169 in the active treatment extension phase.
980275|NCT00865306|O1|Outcome|Active CBT|
980046|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
980047|NCT00866359|O2|Outcome|Apremilast 30 mg BID/Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
980048|NCT00866359|O1|Outcome|Placebo BID/Apremilast 30 BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase .
980049|NCT00866359|O2|Outcome|Apremilast 30mg/Apremilast 30mg|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets twice daily in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast tablets twice daily up to Day 169 in the active treatment extension phase.
980050|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
980051|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially administered to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
980052|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase.
980053|NCT00866359|O2|Outcome|Apremilast 30 mg /Apremilast 30mg BID (Oral)|Extension Phase (Days 86 to 169): Participants initially randomized to receive 30 mg apremilast tablets BID in the 12-week placebo-controlled treatment phase continued to receive 30 mg apremilast BID up to Day 169 in the active treatment extension phase.
980054|NCT00866359|O1|Outcome|Placebo/Apremilast 30 mg|Extension Phase (Days 86 to 169): Participants initially randomized to placebo BID started titration doses to reach 30 mg apremilast tablets BID and remained in that dose up to Day 169 in the active treatment extension phase
980055|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980056|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
980057|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980058|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
980059|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980060|NCT00866359|O1|Outcome|Placebo|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets BID in the 12-week placebo-controlled phase.
980061|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980062|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
980063|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980064|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
980065|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980066|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
980067|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980068|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
980069|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980070|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
980071|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980072|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets twice daily (BID) in the 12-week placebo-controlled phase.
980073|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980074|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
980075|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980076|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
980077|NCT00866359|O2|Outcome|Apremilast 30mg (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase.
980078|NCT00866359|O1|Outcome|Placebo (Oral) BID|Treatment Phase (Days 1 to 85): Participants administered identically matching placebo tablets (BID) in the 12-week placebo-controlled phase.
980079|NCT00866359|E3|Reported Event|Week 24: Apremilast 30 mg BID|Participants who received 30 mg apremilast, regardless of when the apremilast exposure started (at Week 0, or 12), up until Week 24. Includes data through Week 24 for participants who were treated with Apremilast started at Week 0 and data from Week 12 through Week 24 for participants who were treated with Apremilast started at Week 12.
980080|NCT00866359|E2|Reported Event|Week 12: Apremilast 30 mg BID|Participants randomized to 30 mg Apremilast tablets BID during the 12-week placebo-controlled treatment phase. Includes data through Week 12 for all participants randomized to 30mg Apremilast BID.
980081|NCT00866359|E1|Reported Event|Week 12: Placebo BID|Participants randomized to placebo tablets twice daily during the placebo-controlled phase. Includes data through Week 12 for all participants randomized to placebo.
980082|NCT00866320|B1|Baseline|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
980083|NCT00866320|P1|Participant Flow|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
980084|NCT00866320|O1|Outcome|Sorafenib|Patients receive Sorafenib twice a day until disease progression or toxicity
980085|NCT00866320|O1|Outcome|Sorafenib|Sorafenib twice a day until progression or toxicity
980086|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
980087|NCT00866320|O1|Outcome|Sorafenib|Patients receive sorafenib twice a day until disease progression or toxicity.
980088|NCT00866320|E1|Reported Event|Sorafenib|Patients receive Sorafenib 400 mg BID until disease progression or toxicity. Dose may be escalated to 600mg and 800 mg BID after the 8 week disease reassessment.
980089|NCT00866307|B1|Baseline|Induction|All Patients
980090|NCT00866307|P3|Participant Flow|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
980091|NCT00866307|P2|Participant Flow|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM)
980092|NCT00866307|P1|Participant Flow|Induction|All Patients
980093|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
980094|NCT00866307|O1|Outcome|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy
980095|NCT00866307|E3|Reported Event|Group B (High Risk-High)|Patients with day 29 MRD >=0.01% or at least one of: CNS3, Testicular disease, Steroid Pre-treatment, MLL+, or hypodiploidy. Received Intensified PEG-asparaginase therapy.
980096|NCT00866307|E2|Reported Event|Group A (High Risk-Average)|Patients with day 29 MRD <0.01% and no CNS3, testicular disease, steroid pretreatment, MLL+, or hypodiploidy. Treated with Standard PEG-asparaginase therapy (hABFM).
980097|NCT00866307|E1|Reported Event|Induction|All Patients
980098|NCT00866294|B4|Baseline|Total|Total of all reporting groups
980099|NCT00866294|B3|Baseline|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
980100|NCT00866294|B2|Baseline|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
980101|NCT00866294|B1|Baseline|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
980102|NCT00866294|P3|Participant Flow|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
980119|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
980144|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
980145|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
981374|NCT00862082|O1|Outcome|PR104|
980103|NCT00866294|P2|Participant Flow|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
980104|NCT00866294|P1|Participant Flow|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
980105|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980106|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980107|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
980108|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980109|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980110|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
980111|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980112|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980113|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
980114|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980115|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980116|NCT00866294|O1|Outcome|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily.
980117|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980118|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980276|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
980120|NCT00866294|O3|Outcome|Paroxetine IR|An initial dose of 10 or 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 10 mg/day were forced to receive the uptitrated dose of 20 mg/day, and participants who started the treatment from 20 mg/day were maintained at the same dose level. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980121|NCT00866294|O2|Outcome|Paroxetine CR|An initial dose of 12.5 or 25 milligrams (mg)/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. In the second week, participants who started the treatment from 12.5 mg/day were forced to receive the uptitrated dose of 25 mg/day, and participants who started the treatment from 25 mg/day were maintained at the same dose level. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed.
980122|NCT00866294|O1|Outcome|Placebo|Placebo matched to the controlled release formulation (CR) of paroxetine and placebo matched to the immediate release formulation (IR) of paroxetine were administered orally once daily.
980123|NCT00866294|E7|Reported Event|Paroxetine IR, Total|All participants receiving either paroxetine IR 10-40 mg/day or 20-40 mg/day
980124|NCT00866294|E6|Reported Event|Paroxetine IR 20-40 mg/Day|An initial dose of 20 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Thereafter, 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
980125|NCT00866294|E5|Reported Event|Paroxetine IR 10-40 mg/Day|An initial dose of 10 mg/day of paroxetine IR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 20 mg/day, and 20-40 mg/day was administered once daily for 7 weeks. The dose level was increased by 10 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 10 mg/day at weekly intervals to the final dose level of 10 mg/day to complete the treatment.
980126|NCT00866294|E4|Reported Event|Paroxetine CR, Total|All participants receiving either paroxetine CR 12.5-50 mg/day or 25-50 mg/day
980127|NCT00866294|E3|Reported Event|Paroxetine CR 25-50 mg/Day|An initial dose of 25 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Thereafter, 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
980128|NCT00866294|E2|Reported Event|Paroxetine CR 12.5-50 mg/Day|An initial dose of 12.5 mg/day of paroxetine CR was administered orally once daily in the first week of the treatment phase. Then the dose was uptitrated to 25 mg/day, and 25-50 mg/day was administered once daily for 7 weeks. The dose level was increased by 12.5 mg/day at intervals of at least 1 week until sufficient efficacy was confirmed. During the taper phase, the last dose level in the treatment phase was reduced by 12.5 mg/day at weekly intervals to the final dose level of 12.5 mg/day to complete the treatment.
980129|NCT00866294|E1|Reported Event|Placebo|Placebo matched to paroxetine CR and placebo matched to paroxetine IR were administered orally once daily from the start of the treatment phase (8 weeks) through the end of the taper phase (0-3 weeks).
980130|NCT00866281|B3|Baseline|Total|Total of all reporting groups
980131|NCT00866281|B2|Baseline|Cohort 2: Midostaurin (60 mg/m^2)|Participants received body-weight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
980132|NCT00866281|B1|Baseline|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received body-weight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
980133|NCT00866281|P2|Participant Flow|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
980134|NCT00866281|P1|Participant Flow|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 twice daily (bid) through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
980135|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
980136|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
980137|NCT00866281|O2|Outcome|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
980138|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and body surface area (BSA) stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
980139|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
980140|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
980141|NCT00866281|O2|Outcome|MLLr­ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
980142|NCT00866281|O1|Outcome|AML Subjects|Subjects with acute myeloid leukemia (AML) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
980143|NCT00866281|O2|Outcome|MLLr-ALL Subjects|Subjects with mixed lineage leukemia gene­ rearranged acute lymphoblastic leukemia (MLLr­ALL) and received body­weight stratified dosage midostaurin 30 or 60 mg/m^2.
980196|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980146|NCT00866281|O1|Outcome|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
980147|NCT00866281|E2|Reported Event|Cohort 2: Midostaurin (60 mg/m^2)|Participants received bodyweight and BSA stratified dose of midostaurin 60 mg/m^2 bid through oral route. The total daily dose in 60 mg/m^2 bid cohort was 120 mg/m^2.
980148|NCT00866281|E1|Reported Event|Cohort 1: Midostaurin (30 Milligrams/Meters^2)|Participants received bodyweight and BSA stratified dose of midostaurin 30 mg/m^2 bid through oral route. The total daily dose in 30 mg/m^2 bid cohort was 60 mg/m^2.
980149|NCT00866047|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980150|NCT00866047|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
980151|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980152|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980153|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980154|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980155|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980156|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980157|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980158|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980159|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980160|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980161|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980162|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980163|NCT00866047|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980164|NCT00866047|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
980165|NCT00866034|B3|Baseline|Total|Total of all reporting groups
980166|NCT00866034|B2|Baseline|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
980167|NCT00866034|B1|Baseline|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
980168|NCT00866034|P2|Participant Flow|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
980169|NCT00866034|P1|Participant Flow|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
980170|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
980171|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
980172|NCT00866034|O2|Outcome|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
980173|NCT00866034|O1|Outcome|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
980174|NCT00866034|E2|Reported Event|Late Start CD6|Late fixed start of a daily dose of 0.25mg Cetrotide on cycle day 6. As in the other arm of the study, exogenous gonadotropins will commence on cycle day 2.
980175|NCT00866034|E1|Reported Event|Early Start CD2|Early fixed start of a daily dose of 0.25mg Cetrotide on cycle day 2, together with the initiation of daily treatment with exogenous gonadotropins.
980176|NCT00865904|B6|Baseline|Total|Total of all reporting groups
980177|NCT00865904|B5|Baseline|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980178|NCT00865904|B4|Baseline|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980179|NCT00865904|B3|Baseline|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980180|NCT00865904|B2|Baseline|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980181|NCT00865904|B1|Baseline|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980182|NCT00865904|P5|Participant Flow|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980183|NCT00865904|P4|Participant Flow|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980184|NCT00865904|P3|Participant Flow|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980185|NCT00865904|P2|Participant Flow|VX-809, 25 mg|VX-809, 25 milligram (mg) capsule orally once daily for 28 days.
980186|NCT00865904|P1|Participant Flow|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980187|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980188|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980189|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980190|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980191|NCT00865904|O4|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980192|NCT00865904|O3|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980193|NCT00865904|O2|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980194|NCT00865904|O1|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980195|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980277|NCT00865306|O1|Outcome|Active CBT|
980199|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980200|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980201|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980202|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980203|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980204|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980205|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980206|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980207|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980208|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980209|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980210|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980211|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980212|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980213|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980214|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980215|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980216|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980217|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980218|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980219|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980220|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980221|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980222|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980223|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980224|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980225|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980226|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980227|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980228|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980229|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980230|NCT00865904|O5|Outcome|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980231|NCT00865904|O4|Outcome|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980232|NCT00865904|O3|Outcome|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980233|NCT00865904|O2|Outcome|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980234|NCT00865904|O1|Outcome|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980235|NCT00865904|E5|Reported Event|VX-809, 200 mg|VX-809, 200 mg capsule orally once daily for 28 days.
980236|NCT00865904|E4|Reported Event|VX-809, 100 mg|VX-809, 100 mg capsule orally once daily for 28 days.
980237|NCT00865904|E3|Reported Event|VX-809, 50 mg|VX-809, 50 mg capsule orally once daily for 28 days.
980238|NCT00865904|E2|Reported Event|VX-809, 25 mg|VX-809, 25 mg capsule orally once daily for 28 days.
980239|NCT00865904|E1|Reported Event|Placebo|Placebo matched to VX-809 capsule orally once daily for 28 days.
980240|NCT00865709|B3|Baseline|Total|Total of all reporting groups
980241|NCT00865709|B2|Baseline|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980242|NCT00865709|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980243|NCT00865709|P2|Participant Flow|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980244|NCT00865709|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980245|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980246|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980247|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980248|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980278|NCT00865306|O2|Outcome|No Intervention (Wait-list Controls)|
980249|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980250|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980251|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980252|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980253|NCT00865709|O2|Outcome|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980254|NCT00865709|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980255|NCT00865709|E4|Reported Event|Matching Placebo + mFOLFOX6 (OS Update)|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980256|NCT00865709|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6 (OS Update)|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980257|NCT00865709|E2|Reported Event|Matching Placebo + mFOLFOX6|Subjects will receive oral matching placebo 2 tablets BID continuously and IV mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease
980258|NCT00865709|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + mFOLFOX6|Subjects will receive oral Sorafenib 400 mg twice daily (BID) continuously and intravenous (IV) mFOLFOX6 (5-FU 400 mg/m^2 bolus and 2400 mg/m^2 for 46-48 hrs; levo-leucovorin 200 mg/m^2; 85 mg/m^2 oxaliplatin) every 14 days until progressive disease (PD)
980259|NCT00865514|B1|Baseline|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
980260|NCT00865514|P1|Participant Flow|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
980261|NCT00865514|O1|Outcome|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
980262|NCT00865514|O1|Outcome|The Interaction of DCA and/or Tyrosine Breakdown Products|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
980263|NCT00865514|E1|Reported Event|Haplotypes and DCA Metabolism|Healthy men and women with different haplotypes will receive an infusion of leucine and tyrosine. The following day they begin a 5 day course of dichloroacetate (DCA)at a dose of 2.5mcg/kg/day. On day 6 they return and receive another infusion of leucine and tyrosine. After a 30 day washout period the subject returns and again receives an infusion of leucine and tyrosine. Then on day 2 they begin a dose of DCA at 25mg/kg for 5 days and then return for the final infusion of leucine and tyrosine.
980264|NCT00865345|B1|Baseline|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
980265|NCT00865345|P1|Participant Flow|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
980266|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
980267|NCT00865345|O1|Outcome|All Completed Subjects|All subjects that completed the inpatient frequent sampling procedure.
980268|NCT00865345|E1|Reported Event|Subcutaneous Sensor Group|All subjects wore subcutaneous sensors
980269|NCT00865306|B3|Baseline|Total|Total of all reporting groups
980270|NCT00865306|B2|Baseline|No Intervention (Wait-list Controls)|
980271|NCT00865306|B1|Baseline|Active CBT|
980272|NCT00865306|P2|Participant Flow|No Intervention (Wait-list Controls)|This was a 6-month wait-list control condition in which children received no intervention. After participating in the control condition, families who wanted it were offered the opportunity to receive the CBT intervention.
980273|NCT00865306|P1|Participant Flow|Active CBT|This was parent-child CBT, administered to families individually over 6 months, and including six 1-hour parent-only sessions, followed by 8-13 1-hour child-parent sessions, and one final 1-hour parent-only session.
980279|NCT00865306|O1|Outcome|Active CBT|
980284|NCT00865202|B1|Baseline|L-tryptophan|L-tryptophan 1 gm enterally TID starting the evening of the operation
980285|NCT00865202|P2|Participant Flow|Placebo|Similar appearing placebo
980286|NCT00865202|P1|Participant Flow|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
980287|NCT00865202|O2|Outcome|Placebo|Similar appearing placebo
980288|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
980289|NCT00865202|O2|Outcome|Placebo|Similar appearing placebo
980290|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
980291|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
980292|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
980293|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
980294|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
980295|NCT00865202|O2|Outcome|Placebo|similar appearing placebo
980296|NCT00865202|O1|Outcome|Study Drug|L-tryptophan 1 gm PO TID starting the evening of surgery
980297|NCT00865202|E2|Reported Event|Placebo|Similar appearing placebo
980298|NCT00865202|E1|Reported Event|Study Drug|L-tryptophan 1 gm enterally TID starting the evening of the operation
980299|NCT00865124|B4|Baseline|Total|Total of all reporting groups
980300|NCT00865124|B3|Baseline|Placebo Capsule|Placebo: Placebo capsule daily
980301|NCT00865124|B2|Baseline|Hydrochlorothiazide + Potassium|Hydrochlorothiazide + potassium: hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
980302|NCT00865124|B1|Baseline|Spironolactone (MR Blockade)|Spironolactone: 25 mg capsule daily for 6 months
980303|NCT00865124|P3|Participant Flow|Placebo|Placebo capsule daily
980304|NCT00865124|P2|Participant Flow|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 milliequivalents (mEq) capsule daily
980305|NCT00865124|P1|Participant Flow|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
980306|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
980307|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
980308|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
980309|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
980310|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
980311|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
980312|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
980313|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
980314|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
980315|NCT00865124|O3|Outcome|Placebo|Placebo capsule daily
980316|NCT00865124|O2|Outcome|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
980317|NCT00865124|O1|Outcome|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
980318|NCT00865124|E3|Reported Event|Placebo|Placebo capsule daily
980319|NCT00865124|E2|Reported Event|Hydrochlorothiazide + Potassium|Hydrochlorothiazide (HCTZ) + potassium, 12.5 mg/10 mEq capsule daily
980320|NCT00865124|E1|Reported Event|Spironolactone (MR Blockade)|25 mg capsule daily for 6 months
980321|NCT00865098|B1|Baseline|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980322|NCT00865098|P1|Participant Flow|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980323|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980324|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980325|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980403|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980326|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980327|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980328|NCT00865098|O1|Outcome|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980329|NCT00865098|E1|Reported Event|Cetuximab With Radiotherapy|Subjects received cetuximab at an initial dose of 400 mg/m² infused 6 or 7 days before starting radiotherapy (RT). This was followed by subsequent weekly infusions of 250 mg/m² cetuximab administered in combination with radiotherapy (5 days/week) for 6 weeks. Subjects will receive cetuximab until radiographically documented progressive disease or unacceptable toxicity occurs or consent is withdrawn. If RT is delayed, administration of cetuximab every 7 days is continued. If RT is discontinued for any reason, treatment with cetuximab monotherapy every 7 days is continued.
980330|NCT00865046|B4|Baseline|Total|Total of all reporting groups
980331|NCT00865046|B3|Baseline|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980332|NCT00865046|B2|Baseline|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980333|NCT00865046|B1|Baseline|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
980334|NCT00865046|P3|Participant Flow|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980335|NCT00865046|P2|Participant Flow|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980336|NCT00865046|P1|Participant Flow|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
980337|NCT00865046|O3|Outcome|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980338|NCT00865046|O2|Outcome|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980339|NCT00865046|O1|Outcome|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
980340|NCT00865046|E3|Reported Event|Arm 3|"control-PST for 10 weeks~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980341|NCT00865046|E2|Reported Event|Arm 2|"PST once a week for 10 weeks, then control-PST tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute.~Control-Periosteal Stimulation: Acupuncture needles are placed as per the PST intervention, but only the soft tissue needles receive electrical stimulation for one minute."
980342|NCT00865046|E1|Reported Event|Arm 1|"PST once a week for 10 weeks, then tapering over 6 months~Periosteal stimulation: Four acupuncture needles are placed around the knee to the level of the periosteum and two needles are placed pretibially in the soft tissue. All needles are stimulated with 100 Hz current. The stimulation of the needles in the soft tissue is discontinued after one minute."
980343|NCT00865020|B3|Baseline|Total|Total of all reporting groups
980344|NCT00865020|B2|Baseline|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980345|NCT00865020|B1|Baseline|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980346|NCT00865020|P2|Participant Flow|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980347|NCT00865020|P1|Participant Flow|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980348|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980349|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980350|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980351|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980352|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980353|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980354|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980355|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980356|NCT00865020|O2|Outcome|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980357|NCT00865020|O1|Outcome|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980358|NCT00865020|E2|Reported Event|Telmisartan 80 mg|Telmisartan capsules starting at a dose of 40 mg taken orally daily for 2 weeks followed by a dose of 80 mg taken orally daily for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Telmisartan: 1 capsule for the first 2 weeks and 2 capsules during the one week withdrawal period.
980359|NCT00865020|E1|Reported Event|Aliskiren 300 mg|Aliskiren tablets starting at a dose of 150 mg taken orally daily for 2 weeks followed by a dose of 300 mg taken orally for 10 weeks and placebo (withdrawal) for one week. Participants took Placebo to Aliskiren: 1 tablet for the first 2 weeks and 2 tablets during the one week withdrawal period.
980360|NCT00864916|B3|Baseline|Total|Total of all reporting groups
980361|NCT00864916|B2|Baseline|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
980362|NCT00864916|B1|Baseline|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
980363|NCT00864916|P2|Participant Flow|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
980364|NCT00864916|P1|Participant Flow|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
980365|NCT00864916|O2|Outcome|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
980366|NCT00864916|O1|Outcome|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
980367|NCT00864916|E2|Reported Event|Placebo+cART|"Participants will receive placebo and cART.~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Placebo: Participants will receive placebo three times per day for 48 weeks."
980368|NCT00864916|E1|Reported Event|PTX+cART|"Participants will receive pentoxifylline and combination antiretroviral therapy (cART).~Combination antiretroviral therapy (cART): Participants will receive the appropriate cART medications, as prescribed by their primary HIV doctor for 48 weeks. (cART medications may be prescribed beyond the length of this study.)~Pentoxifylline: Participants will receive 400 mg of pentoxifylline three times per day for 48 weeks."
980369|NCT00864851|B4|Baseline|Total|Total of all reporting groups
980370|NCT00864851|B3|Baseline|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980371|NCT00864851|B2|Baseline|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980372|NCT00864851|B1|Baseline|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980373|NCT00864851|P3|Participant Flow|Replagal 0.4 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980374|NCT00864851|P2|Participant Flow|Replagal 0.2 mg/kg, IV, Weekly|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980375|NCT00864851|P1|Participant Flow|Replagal 0.2 mg/kg, IV, Every Other Week|Patients randomized to receive Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980376|NCT00864851|O4|Outcome|Overall|Total of all reporting groups.
980377|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980378|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980379|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980380|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980381|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980382|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980383|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980384|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980385|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980386|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980387|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980388|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980389|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980390|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980391|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980392|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980393|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980394|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980395|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980396|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980397|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980398|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980399|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980400|NCT00864851|O1|Outcome|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980401|NCT00864851|O3|Outcome|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980402|NCT00864851|O2|Outcome|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980404|NCT00864851|E4|Reported Event|Overall|Total of all reporting groups.
980405|NCT00864851|E3|Reported Event|Replagal 0.4 mg/kg, IV, Weekly|Patients who received Replagal 0.4 mg/kg via intravenous infusion every week for 52 weeks.
980406|NCT00864851|E2|Reported Event|Replagal 0.2 mg/kg, IV, Weekly|Patients who received Replagal 0.2 mg/kg via intravenous infusion every week for 52 weeks.
980407|NCT00864851|E1|Reported Event|Replagal 0.2 mg/kg, IV, Every Other Week|Patients who received Replagal 0.2 mg/kg via intravenous infusion every other week for 52 weeks.
980408|NCT00864708|B1|Baseline|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
980409|NCT00864708|P1|Participant Flow|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
980410|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
980411|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
980412|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
980413|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System
980414|NCT00864708|O1|Outcome|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
980415|NCT00864708|O1|Outcome|Arm 1|gait training with radio frequency-controlled (RF) Microstimulator (RFM) Gait System
980416|NCT00864708|E1|Reported Event|Arm 1|Gait training using radio frequency-controlled (RF) Microstimulator (RFM) Gait System )
980417|NCT00864682|B4|Baseline|Total|Total of all reporting groups
980418|NCT00864682|B3|Baseline|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
980419|NCT00864682|B2|Baseline|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
980420|NCT00864682|B1|Baseline|Control Arm|saline pretreatment, saline plus propofol admixture
980421|NCT00864682|P3|Participant Flow|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
980422|NCT00864682|P2|Participant Flow|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
980423|NCT00864682|P1|Participant Flow|Control Arm|saline pretreatment, saline plus propofol admixture
980424|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
980425|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
980426|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
980427|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
980428|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
980429|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
980430|NCT00864682|O3|Outcome|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
980431|NCT00864682|O2|Outcome|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
980432|NCT00864682|O1|Outcome|Control Arm|saline pretreatment, saline plus propofol admixture
980433|NCT00864682|E3|Reported Event|Lidocaine Pretreatment Arm|lidocaine pretreatment, saline plus propofol admixture
980434|NCT00864682|E2|Reported Event|Lidocaine / Propofol Admixture Arm|saline pretreatment, lidocaine plus propofol admixture
980435|NCT00864682|E1|Reported Event|Control Arm|saline pretreatment, saline plus propofol admixture
980436|NCT00864539|B7|Baseline|Total|Total of all reporting groups
980437|NCT00864539|B6|Baseline|Placebo|Subjects receiving daily placebo containing 1 g starch
980438|NCT00864539|B5|Baseline|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
980439|NCT00864539|B4|Baseline|Plain Juice|subjects receiving plain orange juice
980440|NCT00864539|B3|Baseline|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
980441|NCT00864539|B2|Baseline|Plain Milk|daily intake of 200 mL plain milk
980442|NCT00864539|B1|Baseline|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
980443|NCT00864539|P6|Participant Flow|Placebo|Subjects receiving daily placebo containing 1 g starch
980444|NCT00864539|P5|Participant Flow|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
980445|NCT00864539|P4|Participant Flow|Plain Juice|subjects receiving plain orange juice
980446|NCT00864539|P3|Participant Flow|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
980447|NCT00864539|P2|Participant Flow|Plain Milk|daily intake of 200 mL plain milk
980448|NCT00864539|P1|Participant Flow|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
980449|NCT00864539|O6|Outcome|Placebo|Subjects receiving daily placebo containing 1 g starch
980450|NCT00864539|O5|Outcome|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
980451|NCT00864539|O4|Outcome|Plain Juice|subjects receiving plain orange juice
980452|NCT00864539|O3|Outcome|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
980453|NCT00864539|O2|Outcome|Plain Milk|daily intake of 200 mL plain milk
980454|NCT00864539|O1|Outcome|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
980455|NCT00864539|E6|Reported Event|Placebo|Subjects receiving daily placebo containing 1 g starch
980456|NCT00864539|E5|Reported Event|Vitamin D-Calcium Supplement|Subjects receiving daily supplement containing 500 mg + 200 IU vitamin D
980457|NCT00864539|E4|Reported Event|Plain Juice|subjects receiving plain orange juice
980458|NCT00864539|E3|Reported Event|Fortified Orange Juice|daily intake of orange juice fortified with 100 IU vitamin D and 500 mg calcium
980459|NCT00864539|E2|Reported Event|Plain Milk|daily intake of 200 mL plain milk
980460|NCT00864539|E1|Reported Event|Fortified Milk|daily intake of milk fortified with 100 IU vitamin D and 500 mg calcium/200mL
980461|NCT00864513|B1|Baseline|Chemotherapy|pemetrexed
980462|NCT00864513|P1|Participant Flow|Chemotherapy|Subjects will be treated with pemetrexed 500 mg/m2 IV once every 21 days. They are also premdicated with dexamethasone 4 mg po BID on the day before, of and after chemotherapy. They will start folic acid 350-1000mcg by mouth daily, 5-7 days before starting study therapy. They will also receive a 1000 mcg IM injeciton of vitamin B12 1-2 weeks before study drug, and eveyr 9 weeks thereafter, until 3 weeks after the last dose of study treatment
980463|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
980464|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
980465|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
980466|NCT00864513|O1|Outcome|Chemotherapy|pemetrexed
980467|NCT00864513|E1|Reported Event|Chemotherapy|pemetrexed
980468|NCT00864383|B4|Baseline|Total|Total of all reporting groups
980469|NCT00864383|B3|Baseline|Regimen 3 - 2EMRZ/2MR (Ethambutol)|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980470|NCT00864383|B2|Baseline|Regimen 2 - 2MHRZ/2MHR (Isoniazid)|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980471|NCT00864383|B1|Baseline|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980472|NCT00864383|P3|Participant Flow|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980473|NCT00864383|P2|Participant Flow|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980474|NCT00864383|P1|Participant Flow|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980475|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980540|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980541|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980542|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980543|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
982847|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
980476|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980477|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980478|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980479|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980480|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980481|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980482|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980483|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980484|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980616|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980485|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980486|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980487|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980488|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980489|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980490|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980491|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980492|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980493|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980617|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980494|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980495|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980496|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980497|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980498|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980499|NCT00864383|O3|Outcome|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980500|NCT00864383|O2|Outcome|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980501|NCT00864383|O1|Outcome|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980502|NCT00864383|E3|Reported Event|Regimen 3 - 2EMRZ/2MR|"Eight weeks of chemotherapy with Ethambutol, Moxifloxacin, Rifampicin and Pyrazinamide plus the Isoniazid placebo, followed by~Nine weeks of Moxifloxacin and Rifampicin plus the Isoniazid placebo, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980618|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980503|NCT00864383|E2|Reported Event|Regimen 2 - 2MHRZ/2MHR|"Eight weeks of chemotherapy with Moxifloxacin, Isoniazid, Rifampicin and Pyrazinamide plus the Ethambutol placebo, followed by~Nine weeks of Moxifloxacin, Isoniazid and Rifampicin, followed by~Nine weeks of the Isoniazid placebo and the Rifampicin placebo.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980504|NCT00864383|E1|Reported Event|Regimen 1 - 2EHRZ/4HR (Control Regimen)|"Eight weeks of chemotherapy with Ethambutol, Isoniazid, Rifampicin and Pyrazinamide plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin plus the Moxifloxacin placebo, followed by~Nine weeks of Isoniazid and Rifampicin only.~Moxifloxacin, Ethambutol, Isoniazid, Pyrazinamide & Rifampicin: Moxifloxacin 400 mg Rifampicin < 45 kg 450 mg > 45 kg 600 mg Isoniazid 300 mg Pyrazinamide < 40 kg 25 mg/kg rounded to nearest 500 mg* 40-55 kg 1000 mg > 55 kg - 75 kg 1500 mg > 75 kg 2000 mg Ethambutol < 40 kg 15 mg/kg rounded to nearest 100 mg 40-55 kg 800 mg > 55 kg - 75 kg 1200 mg > 75 kg 1600 mg *For pyrazinamide dosing in patients < 40 kg, 1000 mg used instead of 500 mg~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
980505|NCT00864253|B3|Baseline|Total|Total of all reporting groups
980506|NCT00864253|B2|Baseline|Dacarbazine Arm B 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980507|NCT00864253|B1|Baseline|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980508|NCT00864253|P2|Participant Flow|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980509|NCT00864253|P1|Participant Flow|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980510|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980511|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980512|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980513|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980514|NCT00864253|O2|Outcome|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980515|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980516|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980517|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980518|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980519|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980520|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980521|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980522|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980523|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980524|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980525|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980526|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980527|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980528|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980529|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980530|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980531|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980532|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980533|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980534|NCT00864253|O2|Outcome|Dacarbazine 1000mg/m^2|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980535|NCT00864253|O1|Outcome|ABI-007 150mg/m^2|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 every 4 weeks
980536|NCT00864253|E2|Reported Event|Dacarbazine Arm B|Dacarbazine 1000mg/m^2 intravenously over approximately 30-60 minutes on Day 1 of each 21 day cycle.
980537|NCT00864253|E1|Reported Event|ABI-007 Arm A|ABI-007 150mg/m^2 intravenously over approximately 30 minutes on Days 1, 8 and 15 of each 28 day cycle
980538|NCT00864227|B1|Baseline|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980539|NCT00864227|P1|Participant Flow|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980619|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980544|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980545|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980546|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980547|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980548|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980549|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980550|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980551|NCT00864227|O1|Outcome|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980552|NCT00864227|E1|Reported Event|dUCB Transplant|Hematopoietic Umbilical Cord Blood Stem Cell Transplantation using a non-myeloablative preparative regimen.
980553|NCT00864123|B3|Baseline|Total|Total of all reporting groups
980554|NCT00864123|B2|Baseline|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980555|NCT00864123|B1|Baseline|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980556|NCT00864123|P2|Participant Flow|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980557|NCT00864123|P1|Participant Flow|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980558|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980559|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980560|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980561|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980562|NCT00864123|O2|Outcome|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980563|NCT00864123|O1|Outcome|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980564|NCT00864123|E2|Reported Event|Cognitive-behavioral Therapy + D-cycloserine|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of D-cycloserine. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980565|NCT00864123|E1|Reported Event|Cognitive-behavioral Therapy + Placebo|Involves receiving cognitive-behavioral treatment of OCD symptoms for 10 sessions. One hour prior to sessions 4-10, the child will take either 1 or 2 pills containing 25mg of placebo. The number of pills depends on the child's weight (e.g., about 46kgs takes 2 capsules).
980566|NCT00864084|B1|Baseline|Pulmonary Rehabilitation|People with respiratory disease
980567|NCT00864084|P1|Participant Flow|Pulmonary Rehabilitation|An 8-week out-patient pulmonary rehabilitation program.
980568|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
980569|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
980570|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
980571|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
980572|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
980620|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980573|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
980574|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
980575|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
980576|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
980577|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
980578|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
980579|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
980580|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
980581|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
980582|NCT00864084|O2|Outcome|Post-pulmonary Rehabilitation|Participant data after participation in an 8-week outpatient pulmonary rehabilitation program.
980583|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program.
980584|NCT00864084|O4|Outcome|Post-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
980585|NCT00864084|O3|Outcome|Post-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
980586|NCT00864084|O2|Outcome|Pre-pulmonary Rehabilitation - Eyes Closed|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes closed.
980587|NCT00864084|O1|Outcome|Pre-pulmonary Rehabilitation - Eyes Open|Participant data prior to participation in an 8-week outpatient pulmonary rehabilitation program. Standing balance testing by standing on the force plate with eyes open.
980588|NCT00864084|E1|Reported Event|Study Participation|Participant data collection at baseline (pre-pulmonary rehabilitation), participation in an 8-week outpatient pulmonary rehabilitation program and data collection at follow-up (post-pulmonary rehabilitation).
980589|NCT00864032|B1|Baseline|Phase I|
980590|NCT00864032|P3|Participant Flow|Sorafenib 400/400|"Dose level 3 sorafenib 400 mg PO BID with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
980591|NCT00864032|P2|Participant Flow|Sorafenib 200/400|"Dose level 2 sorafenib 200 mg PO Q AM and 400 mg PO Q PM with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent.~Traditional 3+3 dose escalation Phase I trial. Cohort 2 enrolled after completion of all 3 participants in dose level 1."
980592|NCT00864032|P1|Participant Flow|Sorafenib 200/200|"Dose level 1 sorafenib 200 bid with concurrent neoadjuvant radiation therapy.~sorafenib administered orally. agent administered during concurrent neoadjuvant radiation therapy. both modalities discontinued approximately 4 - 6 weeks prior to surgical resection with curative intent."
980593|NCT00864032|O2|Outcome|Sorafenib 200/400|
980594|NCT00864032|O1|Outcome|Sorafenib 200/200|
980595|NCT00864032|E2|Reported Event|Sorafenib 200/400|Dose level 2. Sorafenib 200 mg PO Q AM and 400 mg PO Q PM
980596|NCT00864032|E1|Reported Event|Sorafenib 200/200|Dose level 1. Sorafenib 200 mg PO BID
980597|NCT00863798|B4|Baseline|Total|Total of all reporting groups
980598|NCT00863798|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980599|NCT00863798|B2|Baseline|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980600|NCT00863798|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980601|NCT00863798|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980602|NCT00863798|P2|Participant Flow|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980603|NCT00863798|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980604|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980605|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980606|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980607|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980608|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980609|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980610|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980611|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980612|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980613|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980614|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980615|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980621|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980622|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980623|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980624|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980625|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980626|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980627|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980628|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980629|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980630|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980631|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980632|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980633|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980634|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980635|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980636|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980637|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980638|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980639|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980640|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980641|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980642|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980643|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980644|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980645|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980646|NCT00863798|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980647|NCT00863798|O2|Outcome|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980648|NCT00863798|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980649|NCT00863798|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
980650|NCT00863798|E2|Reported Event|DVS SR 10 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 10 mg daily until Day 56 (Week 8) or ET.
980651|NCT00863798|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET).
980652|NCT00863746|B3|Baseline|Total|Total of all reporting groups
980653|NCT00863746|B2|Baseline|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980654|NCT00863746|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980655|NCT00863746|P2|Participant Flow|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980656|NCT00863746|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980657|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980658|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980659|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980660|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980661|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980662|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980663|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980664|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980665|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980666|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980667|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980668|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980669|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980670|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980671|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980672|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980673|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980674|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980675|NCT00863746|O2|Outcome|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980747|NCT00863343|B1|Baseline|Participants w/ Disease|Positive for Flu A by reference test
980676|NCT00863746|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID)
980677|NCT00863746|E2|Reported Event|Placebo|Participants received 2 tablets of placebo orally twice daily (BID)
980678|NCT00863746|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 tablets of Sorafenib (2x200 mg) orally twice daily (BID)
980679|NCT00863707|B3|Baseline|Total|Total of all reporting groups
980680|NCT00863707|B2|Baseline|Regadenoson|0.4 mg/5 mL intravenous bolus injection
980681|NCT00863707|B1|Baseline|Placebo|Matching intravenous (IV) bolus injection
980682|NCT00863707|P2|Participant Flow|Regadenoson|0.4 mg/5 mL intravenous bolus injection
980683|NCT00863707|P1|Participant Flow|Placebo|Matching intravenous (IV) bolus injection
980684|NCT00863707|O2|Outcome|Regadenoson|0.4 mg/5 mL intravenous bolus injection
980685|NCT00863707|O1|Outcome|Placebo|Matching intravenous (IV) bolus injection
980686|NCT00863707|E2|Reported Event|Regadenoson|0.4 mg/5 mL intravenous bolus injection
980687|NCT00863707|E1|Reported Event|Placebo|Matching intravenous (IV) bolus injection
980688|NCT00863655|B3|Baseline|Total|Total of all reporting groups
980689|NCT00863655|B2|Baseline|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980690|NCT00863655|B1|Baseline|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980691|NCT00863655|P2|Participant Flow|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980692|NCT00863655|P1|Participant Flow|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980693|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980694|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980695|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980696|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980697|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980698|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980699|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980700|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980701|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980702|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980703|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980704|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980705|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980706|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980707|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980708|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980709|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980710|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980711|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980712|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980713|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980714|NCT00863655|O2|Outcome|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980715|NCT00863655|O1|Outcome|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980716|NCT00863655|E2|Reported Event|Placebo + Exemestane|Placebo of everolimus in combination with exemestane 25 mg daily
980717|NCT00863655|E1|Reported Event|Everolimus + Exemestane|Everolimus 10 mg daily in combination with exemestane 25 mg daily
980718|NCT00863551|B1|Baseline|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980719|NCT00863551|P1|Participant Flow|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980720|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980721|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980722|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980723|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980724|NCT00863551|O1|Outcome|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980725|NCT00863551|E1|Reported Event|Trospium Chloride Extended Release, 60 mg|Trospium Chloride Extended Release, 60 mg
980726|NCT00863512|B3|Baseline|Total|Total of all reporting groups
980727|NCT00863512|B2|Baseline|Arm II (Observation)|Patients receive standard care (observation).
980728|NCT00863512|B1|Baseline|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
980729|NCT00863512|P2|Participant Flow|Arm II (Observation)|Patients receive standard care (observation).
980748|NCT00863343|P2|Participant Flow|Participants w/o Disease|Participants without Flu A by reference method
980730|NCT00863512|P1|Participant Flow|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
980731|NCT00863512|O2|Outcome|Arm II (Observation)|Patients receive standard care (observation).
980732|NCT00863512|O1|Outcome|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
980733|NCT00863512|E2|Reported Event|Arm I (Chemotherapy)|Patients receive cisplatin 75 mg/m^2 by IV on day 1 and vinorelbine ditartrate 30 mg/m^2 by IV on days 1 and 8 OR docetaxel 75 mg/m^2 by IV and cisplatin 75 mg/m^2 by IV on day 1 OR gemcitabine hydrochloride 1200 mg/m^2 by IV on days 1 and 8 and cisplatin 75 mg/m^2 by IV on day 1 OR pemetrexed disodium 500 mg/m^2 by IV and 75 mg/m^2 by cisplatin IV on day 1. Treatment repeats every 21 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
980734|NCT00863512|E1|Reported Event|Arm II (Observation)|Patients receive standard care (observation).
980735|NCT00863434|B1|Baseline|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
980736|NCT00863434|P1|Participant Flow|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
980737|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
980738|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
980739|NCT00863434|O1|Outcome|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
980740|NCT00863434|E1|Reported Event|Treatment (Colony Stimulating Factor and Chemotherapy)|"Patients receive G-CSF SC QD on days 1-5 and clofarabine IV over 1 hour and cytarabine IV on days 2-5. Beginning approximately 1 month later, patients may receive one additional course of treatment in the absence of disease progression or unacceptable toxicity.~clofarabine: Given IV~cytarabine: Given IV~filgrastim: Given SC"
980741|NCT00863356|B1|Baseline|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
980742|NCT00863356|P1|Participant Flow|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
980743|NCT00863356|O1|Outcome|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
980744|NCT00863356|E1|Reported Event|Epistaxis Group|"Subjects presenting with epistaxis that have not been controlled by traditional nasal packing, or that recurred immediately upon removal of the nasal packing will be included in this study. Subject will be evaluated during the packing period to determine the effect of hemostasis. Chitosan coated packing will be removed after 48 hours. Subjects' nasal cavities will be examined endoscopically to evaluate bleeding control, morphological changes induced by the chitosan coated packing.~One week after the removal of the packing, the patients will be endoscopically examined to assess the healing of the packed area, to monitor control of bleeding, and observe any potential delayed reaction to the packing material."
980745|NCT00863343|B3|Baseline|Total|Total of all reporting groups
980746|NCT00863343|B2|Baseline|Participants w/o Disease|Participants without Flu A by reference method
982848|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
980749|NCT00863343|P1|Participant Flow|Participants w/ Disease|Positive for Flu A by reference test
980750|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
980751|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
980752|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
980753|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
980754|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu B by reference method
980755|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu B by reference test
980756|NCT00863343|O2|Outcome|Participants w/o Disease|Participants without Flu A by reference method
980757|NCT00863343|O1|Outcome|Participants w/ Disease|Positive for Flu A by reference test
980758|NCT00863343|E2|Reported Event|Participants w/o Disease|Participants without Flu by reference method
980759|NCT00863343|E1|Reported Event|Participants With Disease|Positive for Flu by reference test
980760|NCT00863330|B1|Baseline|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
980761|NCT00863330|P1|Participant Flow|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
980762|NCT00863330|O1|Outcome|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
980763|NCT00863330|E1|Reported Event|Determine Toxicity of Treatment Regimen.|Tumor Infiltrating Lymphocytes (TIL): Tumor harvest process tumor infiltrating lymphocytes. Non myeloblative chemotherapy consisting of cyclophosphamide and fludarabine. Infusion of TIL cells followed by high dose IL-2.
980764|NCT00863317|B3|Baseline|Total|Total of all reporting groups
980765|NCT00863317|B2|Baseline|Sucrose|sucrose: table sugar as placebo daily for 14 days
980766|NCT00863317|B1|Baseline|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
980767|NCT00863317|P2|Participant Flow|Placebo|sucrose: table sugar as placebo daily for 14 days
980768|NCT00863317|P1|Participant Flow|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
980769|NCT00863317|O2|Outcome|Placebo|sucrose: table sugar as placebo daily for 14 days
980770|NCT00863317|O1|Outcome|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
980771|NCT00863317|E2|Reported Event|Placebo|sucrose: table sugar as placebo daily for 14 days
980772|NCT00863317|E1|Reported Event|Montelukast|"4mg granules~montelukast sodium: 4mg granules daily for 14 days"
980773|NCT00863109|B1|Baseline|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
980774|NCT00863109|P1|Participant Flow|PEG + RBV (Standard Clinical Practice)|Participants receive peginterferon alfa-2b (PEG) and ribavirin (RBV) in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
980775|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
980776|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
980777|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
980778|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
980779|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
980780|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
980781|NCT00863109|O2|Outcome|PEG + RBV (Standard Clinical Practice): Early End of Treatment|Participants who did not complete 48 weeks of PEG and RBV in combination therapy according to standard clinical practice but instead had an early end of treatment. Treatment was followed by 24 weeks of observation.
980782|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice): Completed Treatment|Participants who completed 48 weeks of PEG and RBV in combination therapy according to standard clinical practice followed by 24 weeks of observation.
980783|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
980784|NCT00863109|O1|Outcome|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
980785|NCT00863109|E1|Reported Event|PEG + RBV (Standard Clinical Practice)|Participants receive PEG and RBV in combination therapy for 48 weeks according to standard clinical practice followed by 24 weeks of observation.
980786|NCT00863057|B5|Baseline|Total|Total of all reporting groups
980797|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980961|NCT00862654|B3|Baseline|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
980787|NCT00863057|B4|Baseline|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980788|NCT00863057|B3|Baseline|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980789|NCT00863057|B2|Baseline|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980790|NCT00863057|B1|Baseline|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980791|NCT00863057|P4|Participant Flow|D-P + MTD-P, Then D + MTD, Then D-P + MTD, Then D + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone placebo, (Period 2, Weeks 6 to 9) duloxetine and methadone, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone, (Period 4, Weeks 16 to 19) duloxetine and methadone placebo~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980792|NCT00863057|P3|Participant Flow|D + MTD, Then D + MTD-P, Then D-P + MTD-P, Then D-P + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine and methadone, (Period 2, Weeks 6 to 9) duloxetine and methadone placebo, (Period 3, Weeks 11 to 14) duloxetine placebo and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine placebo and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980793|NCT00863057|P2|Participant Flow|D-P + MTD, Then D-P + MTD-P, Then D + MTD-P, Then D + MTD|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine placebo and methadone, (Period 2,Weeks6 to9)duloxetine placebo and methadone placebo, (Period 3, Weeks 11 to 14)duloxetine and methadone placebo, (Period 4, Weeks 16 to 19) duloxetine and methadone~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980794|NCT00863057|P1|Participant Flow|D + MTD-P, Then D-P + MTD, Then D+MTD, Then D-P + MTD-P|"Participants will receive treatment in the following order: (Period 1, Weeks 1 to 4) duloxetine(D) and methadone placebo (MTD-P), (Period 2, Weeks 6 to 9) duloxetine placebo(D-P) and methadone(MTD), (Period 3, Weeks 11 to 14) duloxetine(D) and methadone(MTD), (Period 4, Weeks 16 to 19) duloxetine placebo(D-P) and methadone placebo(MTD-P)~Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments."
980795|NCT00863057|O2|Outcome|Duloxetine|Maximum tolerated daily dose of Duloxetine was reported.
980796|NCT00863057|O1|Outcome|Methadone|Maximum tolerated daily dose of Methadone was reported.
980798|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980799|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980800|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980801|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980802|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980803|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980804|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980805|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980806|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980807|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980808|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980809|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980810|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980811|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980812|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980813|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980814|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980815|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980816|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980841|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
980842|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
980843|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
980817|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980818|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980819|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980820|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980821|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980822|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980823|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980824|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980825|NCT00863057|O4|Outcome|Duloxetine Placebo and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980826|NCT00863057|O3|Outcome|Duloxetine Placebo and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980827|NCT00863057|O2|Outcome|Duloxetine and Methadone Placebo|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980828|NCT00863057|O1|Outcome|Duloxetine and Methadone|Methadone and matching placebo were initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6, and thereafter titrated to target dose of 10mg TID by Day 11. Duloxetine and matching placebo were initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6.
980829|NCT00863057|E4|Reported Event|Duloxetine Placebo and Methadone Placebo|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
980830|NCT00863057|E3|Reported Event|Duloxetine Placebo and Methadone|Duloxetine placebo was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
980831|NCT00863057|E2|Reported Event|Duloxetine and Methadone Placebo|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone placebo was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
980832|NCT00863057|E1|Reported Event|Duloxetine and Methadone|Duloxetine was initiated at 30mg daily for 5 days and thereafter titrated to a target dose of 60mg daily at Day 6. Methadone was initiated at 5mg twice daily (BID), titrated to 5mg three times daily (TID) on Day 6,and thereafter titrated to target dose of 10mg TID by Day 11. Each treatment period lasted four weeks and was followed by a 1-week combined taper and washout. Flexible dosing allowed participants to receive either the target ceiling dose or the maximum tolerated dose of study treatments.
980833|NCT00862940|B3|Baseline|Total|Total of all reporting groups
980834|NCT00862940|B2|Baseline|Placebo Tablets Twice Daily|
980835|NCT00862940|B1|Baseline|Memantine 10 mg Tablets Twice Daily|
980836|NCT00862940|P2|Participant Flow|Placebo Tablets Twice Daily|
980837|NCT00862940|P1|Participant Flow|Memantine 10 mg Tablets Twice Daily|
980838|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
980839|NCT00862940|O1|Outcome|Memantine 10 mg Tablets Twice Daily|
980840|NCT00862940|O2|Outcome|Placebo Tablets Twice Daily|
980848|NCT00862849|B1|Baseline|All Participants|"All participants were randomized to 1 of 6 treatment sequences (ABC, ACB, BAC, BCA, CAB, or CBA), each of which was comprised of the same 3 interventions (A, B, and C).~Intervention A: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Intervention B: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Intervention C: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions.~The treatment sequence (ABC, ACB, BAC, BCA, CAB, or CBA) was repeated once so that each participant received up to 6 injections."
980849|NCT00862849|P6|Participant Flow|Lispro Alone First, Then RHI+rHuPH20, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
980850|NCT00862849|P5|Participant Flow|Lispro Alone First, Then Lispro+rHuPH20, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro alone~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
980851|NCT00862849|P4|Participant Flow|RHI+rHuPH20 First, Then Lispro Alone, Then Lispro+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
980852|NCT00862849|P3|Participant Flow|RHI+rHuPH20 First, Then Lispro+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
980853|NCT00862849|P2|Participant Flow|Lispro+rHuPH20 First, Then Lispro Alone, Then RHI+rHuPH20|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg insulin lispro alone~Interventions 3 and 6: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
980854|NCT00862849|P1|Participant Flow|Lispro+rHuPH20 First, Then RHI+rHuPH20, Then Lispro Alone|"Interventions 1 and 4: a single, subcutaneous (SC) injection of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20)~Interventions 2 and 5: a single, SC injection of 0.15 U/kg regular human insulin (RHI) with 3.75 ng/kg rHuPH20~Interventions 3 and 6: a single, SC injection of 0.15 U/kg insulin lispro alone~There was a washout period of 3 to 14 days between interventions. The sequence of interventions was repeated so that each participant received up to 6 injections."
980855|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
980856|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980857|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980858|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
980859|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980860|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980861|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
980862|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980863|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980864|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
980865|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980866|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980867|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
980868|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980869|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980870|NCT00862849|O3|Outcome|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
980871|NCT00862849|O2|Outcome|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980872|NCT00862849|O1|Outcome|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980873|NCT00862849|E3|Reported Event|Insulin Lispro Alone|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro alone, 9 to 42 days apart
980874|NCT00862849|E2|Reported Event|Regular Human Insulin + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) regular human insulin (RHI) with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980875|NCT00862849|E1|Reported Event|Insulin Lispro + rHuPH20|Two, subcutaneous (SC) injections of 0.15 units per kilogram (U/kg) insulin lispro with 3.75 nanograms per kilogram (ng/kg) recombinant human hyaluronidase (rHuPH20), 9 to 42 days apart
980876|NCT00862836|B1|Baseline|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980877|NCT00862836|P1|Participant Flow|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980878|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980879|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980880|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980881|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980882|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980883|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980884|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980885|NCT00862836|O1|Outcome|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980886|NCT00862836|E1|Reported Event|Vandetanib 100 mg|Once daily oral Vandetanib 100 mg added to standard therapy (pegylated liposomal doxorubicin 50 mg/m2 iv every 4 weeks)
980887|NCT00862823|B1|Baseline|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
980888|NCT00862823|P2|Participant Flow|Liquid First, Then Tablet|Single dose of Atripla liquid in first intervention period and single dose of Atripla tablet in second intervnetion period
980889|NCT00862823|P1|Participant Flow|Tablet First, Then Liquid|Single dose of Atripla tablet in first intervention period and Single dose of Atripla liquid in second intervnetion period
980890|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
980891|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
980892|NCT00862823|O2|Outcome|Atripla Liquid|Includes groups randomized to receive tablet first and liquid first
980893|NCT00862823|O1|Outcome|Atripla Tablet|Includes groups randomized to receive tablet first and liquid first
980894|NCT00862823|E1|Reported Event|Entire Study Population|Includes groups randomized to receive tablet first and liquid first
980895|NCT00862810|B3|Baseline|Total|Total of all reporting groups
980896|NCT00862810|B2|Baseline|Received Concomitant Vaccines First|Received concomitant vaccines first
980897|NCT00862810|B1|Baseline|Received HPV Vaccine First|Received HPV vaccine first
980898|NCT00862810|P2|Participant Flow|Received Concomitant Vaccines First|Received Concomitant Vaccines First
980899|NCT00862810|P1|Participant Flow|Received HPV Vaccine First|Received HPV vaccine first
980900|NCT00862810|O2|Outcome|Received Concomitant Vaccines First|Received concomitant vaccines first
980901|NCT00862810|O1|Outcome|Received HPV Vaccine First|Received HPV vaccine first
980902|NCT00862810|E2|Reported Event|Received Concomitant Vaccines First|Received concomitant vaccines first
980903|NCT00862810|E1|Reported Event|Received HPV Vaccine First|Received HPV vaccine first
980904|NCT00862784|B1|Baseline|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980962|NCT00862654|B2|Baseline|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
980963|NCT00862654|B1|Baseline|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
980964|NCT00862654|P4|Participant Flow|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
980965|NCT00862654|P3|Participant Flow|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
980905|NCT00862784|P1|Participant Flow|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980906|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980907|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980908|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980909|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980910|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980911|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980912|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980913|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980966|NCT00862654|P2|Participant Flow|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
980967|NCT00862654|P1|Participant Flow|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
980968|NCT00862654|O4|Outcome|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
980969|NCT00862654|O3|Outcome|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
980914|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980915|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980916|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980917|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980918|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980919|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980920|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980921|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980922|NCT00862784|O1|Outcome|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980970|NCT00862654|O2|Outcome|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
980971|NCT00862654|O1|Outcome|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
980972|NCT00862654|E4|Reported Event|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
980973|NCT00862654|E3|Reported Event|C Propionate 2/Week|Clobetasol propionate shampoo 0.05% (2/week)
980923|NCT00862784|E1|Reported Event|IMC-1121B (Ramucirumab) + mFOLFOX-6|"Received IMC-1121B (ramucirumab) 8 milligrams/kilogram (mg/kg) on Day 1 administered intravenously over 60 minutes and followed by administration of the modified FOLFOX-6 [folinic acid (FA) + fluorouracil (5-FU) + oxaliplatin, mFOLFOX-6] regimen as follows:~Oxaliplatin 85 milligrams/square meter (mg/m²) intravenous infusion over 2 hours on Day 1; FA 400 mg/m² intravenous infusion over 2 hours on Day 1; 5-FU 400 mg/m² intravenous bolus injection over 2 to 4 minutes, immediately following the FA infusion; 5-FU 2400 mg/m² intravenous continuous infusion over 46 hours immediately following bolus 5-FU injection on Days 1 and 2.~This regimen was repeated every 2 weeks until disease progression, unacceptable toxicity, or withdrawal."
980924|NCT00862745|B3|Baseline|Total|Total of all reporting groups
980925|NCT00862745|B2|Baseline|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
980926|NCT00862745|B1|Baseline|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
980927|NCT00862745|P2|Participant Flow|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
980928|NCT00862745|P1|Participant Flow|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
980929|NCT00862745|O2|Outcome|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
980930|NCT00862745|O1|Outcome|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
980931|NCT00862745|E2|Reported Event|Placebo|placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.
980932|NCT00862745|E1|Reported Event|Fesoterodine|fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.
980933|NCT00862719|B5|Baseline|Total|Total of all reporting groups
980934|NCT00862719|B4|Baseline|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
980935|NCT00862719|B3|Baseline|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
980936|NCT00862719|B2|Baseline|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
980937|NCT00862719|B1|Baseline|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
980938|NCT00862719|P4|Participant Flow|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
980939|NCT00862719|P3|Participant Flow|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
980940|NCT00862719|P2|Participant Flow|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
980941|NCT00862719|P1|Participant Flow|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
980942|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
980943|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
980944|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
980945|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
980946|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
980947|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
980948|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
980949|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
980950|NCT00862719|O4|Outcome|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
980951|NCT00862719|O3|Outcome|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
980952|NCT00862719|O2|Outcome|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
980953|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
980954|NCT00862719|O1|Outcome|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
980955|NCT00862719|E4|Reported Event|600 mg Sitagliptin/8 Hrs|600 mg sitagliptin/tid PO starting on Day -1 for a total of 12 doses
980956|NCT00862719|E3|Reported Event|600 mg Sitagliptin/12 Hrs|600 mg sitagliptin/bid PO starting on Day -1 for a total of 8 doses
980957|NCT00862719|E2|Reported Event|Red Cell-Replete, Plasma-Depleted (PD) - 600 mg Sitagliptin/24|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-replete patients
980958|NCT00862719|E1|Reported Event|Red Cell-Depleted (RCD) - 600 mg Sitagliptin/24 Hrs|600 mg sitagliptin/day PO starting on Day -1 for a total of 4 doses in red cell-depleted patients
980959|NCT00862654|B5|Baseline|Total|Total of all reporting groups
980960|NCT00862654|B4|Baseline|Ketakonazol 2/Week|Ketoconazole shampoo 2% (2/week)
980974|NCT00862654|E2|Reported Event|C Propionate 2/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week)
980975|NCT00862654|E1|Reported Event|C Propionate 4/Week + Ketoconazole 2/Week|Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week)
980976|NCT00862641|B5|Baseline|Total|Total of all reporting groups
980977|NCT00862641|B4|Baseline|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980978|NCT00862641|B3|Baseline|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980979|NCT00862641|B2|Baseline|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
980980|NCT00862641|B1|Baseline|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
980981|NCT00862641|P4|Participant Flow|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980982|NCT00862641|P3|Participant Flow|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980983|NCT00862641|P2|Participant Flow|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
980984|NCT00862641|P1|Participant Flow|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
980985|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980986|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980987|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
980988|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
980989|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980990|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980991|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
980992|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
980993|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980994|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980995|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
980996|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
980997|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980998|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
980999|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
981000|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
981001|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981002|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981003|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
981004|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
981005|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981006|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981007|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
981008|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
981009|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981010|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981011|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
981012|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
981013|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981014|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981015|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
981016|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
981017|NCT00862641|O4|Outcome|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981018|NCT00862641|O3|Outcome|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981019|NCT00862641|O2|Outcome|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
981020|NCT00862641|O1|Outcome|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
981021|NCT00862641|E4|Reported Event|Regadenoson - COPD|0.4mg / 5mL intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981022|NCT00862641|E3|Reported Event|Placebo - COPD|Matching intravenous bolus injection, subjects with Chronic Obstructive Pulmonary Disease (COPD)
981023|NCT00862641|E2|Reported Event|Regadenoson - Asthma|0.4mg / 5mL intravenous bolus injection, subjects with Asthma
981024|NCT00862641|E1|Reported Event|Placebo - Asthma|Matching intravenous (IV) bolus injection, subjects with Asthma
981026|NCT00862563|B4|Baseline|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
981027|NCT00862563|B3|Baseline|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
981028|NCT00862563|B2|Baseline|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
981029|NCT00862563|B1|Baseline|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
981030|NCT00862563|P4|Participant Flow|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
981031|NCT00862563|P3|Participant Flow|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
981032|NCT00862563|P2|Participant Flow|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
981033|NCT00862563|P1|Participant Flow|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
981034|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
981035|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
981036|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
981037|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
981038|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
981039|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
981040|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
981041|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
981042|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
981043|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
981044|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
981045|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
981046|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
981047|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
981048|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
981049|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
981050|NCT00862563|O4|Outcome|Sugar Pill|"Encapsulated sugar pill with a target maintenance dose administered as 4 capsules per day.~Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14."
981051|NCT00862563|O3|Outcome|Topiramate|"Encapsulated topiramate with a target maintenance doses of 300 mg/day administered as 4 capsules per day .~topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate."
981052|NCT00862563|O2|Outcome|Levetiracetam|"Encapsulated levetiracetam with a target maintenance doses of 2000 mg/day administered as 4 capsules per day .~Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules."
981053|NCT00862563|O1|Outcome|Zonisamide|"Encapsulated zonisamide with a target maintenance doses of 400 mg/day administered as 4 capsules per day.~zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide."
981054|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
981055|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
981056|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
981057|NCT00862563|O1|Outcome|Zonisamide|Zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
981058|NCT00862563|O4|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
981059|NCT00862563|O3|Outcome|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
981060|NCT00862563|O2|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
981061|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
981062|NCT00862563|O4|Outcome|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
981063|NCT00862563|O3|Outcome|Topiramate|Topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
981064|NCT00862563|O2|Outcome|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
981065|NCT00862563|O1|Outcome|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
981066|NCT00862563|E4|Reported Event|Sugar Pill|Placebo: Matched placebo will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14.
981067|NCT00862563|E3|Reported Event|Topiramate|topiramate: Topiramate will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses 300 mg topiramate.
981068|NCT00862563|E2|Reported Event|Levetiracetam|Levetiracetam: Levetiracetam will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 mg levetiracetam capsules.
981069|NCT00862563|E1|Reported Event|Zonisamide|zonisamide: Zonisamide will be administered orally twice daily beginning on Day 1, Week 1 and continue through Day 7, Week 14. Subjects will be dose titrated as tolerated to a target doses of 2000 400 mg of zonisamide.
981070|NCT00862537|B1|Baseline|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
981071|NCT00862537|P1|Participant Flow|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
981072|NCT00862537|O1|Outcome|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
981073|NCT00862537|E1|Reported Event|Active Resontaor Device Therapy|active pico-tesla magnetic fields Resonator device therapy
981074|NCT00862459|B4|Baseline|Total|Total of all reporting groups
981075|NCT00862459|B3|Baseline|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981076|NCT00862459|B2|Baseline|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981077|NCT00862459|B1|Baseline|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 millimole per kilogram of body weight (mmol/kg BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
981078|NCT00862459|P3|Participant Flow|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981079|NCT00862459|P2|Participant Flow|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981080|NCT00862459|P1|Participant Flow|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg body weight (BW) of Gadobutrol and one dose of 0.1 mmol/kg BW of OptiMARK. The order in which the participants received Gadobutrol and OptiMARK was randomized. Gadobutrol was administered via a power injector at a rate of 5 milliliter per second (mL/s) followed by a 20 mL 0.9% saline flush at the same rate.
981081|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981082|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981083|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981084|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981085|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981086|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981087|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981088|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981089|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981090|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981091|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981092|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981093|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981094|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981095|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981096|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981097|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981098|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981099|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981100|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981101|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981102|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981103|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981104|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981105|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981106|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981107|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981108|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981109|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981110|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981111|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981112|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981113|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981114|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981115|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981116|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981117|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981118|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981119|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981120|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981121|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981122|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981123|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981124|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981125|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981126|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981127|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981128|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981129|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981130|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981131|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981132|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981133|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981134|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981135|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981136|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981137|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981138|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981139|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981140|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981141|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981142|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981143|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981144|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981145|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981146|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981147|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981148|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981149|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981150|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981151|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981152|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981153|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981154|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981155|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981156|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981157|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981158|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981159|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981160|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981161|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981162|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981163|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981164|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981165|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981166|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981167|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981168|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981169|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981170|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981171|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981172|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981173|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981174|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981175|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981176|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981177|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981178|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981179|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981180|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981181|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981182|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981183|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981184|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981185|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981186|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981187|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981188|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981189|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981190|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981191|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981192|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981193|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981194|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981195|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981196|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981197|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981198|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981199|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981200|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981201|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981202|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981203|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981204|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981205|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981206|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981207|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981208|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981209|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981210|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981211|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981212|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981213|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981214|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981215|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981216|NCT00862459|O3|Outcome|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981217|NCT00862459|O2|Outcome|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981218|NCT00862459|O1|Outcome|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981219|NCT00862459|E4|Reported Event|Optimark~0.1mmol/kg BW|Reporting group 4 (RG4): Participant received one dose of 0.1 mmol/kg BW of OptiMARK. OptiMARK was administered via a power injector at a rate of 2 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981220|NCT00862459|E3|Reported Event|Gadobutrol~0.3 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 3 (RG3): Participant received one dose of 0.3 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981221|NCT00862459|E2|Reported Event|Gadobutrol~0.1 mmol/kg BW (Gadavist, BAY86-4875)|Reporting group 2 (RG2): Participant received one dose of 0.1 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981222|NCT00862459|E1|Reported Event|Gadobutrol~0.03 mmol/kg BW (Gadavist, BAY86-4875)|Reporting Group 1 (RG1): Participant received one dose of 0.03 mmol/kg BW of Gadobutrol. Gadobutrol was administered via a power injector at a rate of 5 mL/s followed by a 20 mL 0.9% saline flush at the same rate.
981223|NCT00862277|B4|Baseline|Total|Total of all reporting groups
981224|NCT00862277|B3|Baseline|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
981225|NCT00862277|B2|Baseline|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
981226|NCT00862277|B1|Baseline|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
981227|NCT00862277|P3|Participant Flow|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
981228|NCT00862277|P2|Participant Flow|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
981229|NCT00862277|P1|Participant Flow|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
981230|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
981231|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
981232|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
981233|NCT00862277|O3|Outcome|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
981234|NCT00862277|O2|Outcome|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
981235|NCT00862277|O1|Outcome|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
981236|NCT00862277|E3|Reported Event|Group 3: Control|Meningococcal vaccine-naive, age-matched participants
981237|NCT00862277|E2|Reported Event|Group 2: Menomune® From Previous Study|Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
981238|NCT00862277|E1|Reported Event|Group 1: Menactra® From Previous Studies|Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
981239|NCT00862251|B4|Baseline|Total|Total of all reporting groups
981240|NCT00862251|B3|Baseline|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981241|NCT00862251|B2|Baseline|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981242|NCT00862251|B1|Baseline|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981243|NCT00862251|P3|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981244|NCT00862251|P2|Participant Flow|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981245|NCT00862251|P1|Participant Flow|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981246|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981247|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981248|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981249|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981250|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981251|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981252|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981253|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981254|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981255|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981256|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981257|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981258|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981259|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981260|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981261|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981262|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981263|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981264|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981265|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981266|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981267|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981268|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981269|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981270|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981271|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981272|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981273|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981274|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981275|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981276|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981277|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981278|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981279|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
981280|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981281|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
981282|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981283|NCT00862251|O3|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981284|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981285|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981286|NCT00862251|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981287|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981288|NCT00862251|O2|Outcome|Doubling Atorvastatin Dose|atorvastatin 20 mg tablets, taken once daily for six weeks.
981289|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981290|NCT00862251|O2|Outcome|Doubling Simvastatin Dose|simvastatin 40 mg tablets, taken once daily for six weeks.
981291|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981292|NCT00862251|O2|Outcome|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981293|NCT00862251|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981294|NCT00862251|E3|Reported Event|Rosuvastatin|Rosuvastatin 10 mg tablets, taken once daily for six weeks.
981295|NCT00862251|E2|Reported Event|Doubling Statin Dose|simvastatin 40 mg or atorvastatin 20 mg tablets, taken once daily for six weeks.
981296|NCT00862251|E1|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/simvastatin 10/20 mg tablets, taken once daily for six weeks
981297|NCT00862186|B1|Baseline|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
981375|NCT00862082|O2|Outcome|Cohort 2|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981376|NCT00862082|O1|Outcome|Cohort 1|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981377|NCT00862082|O1|Outcome|Cohorts 1 and 2|770 and 550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981378|NCT00862082|E2|Reported Event|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
982849|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
981298|NCT00862186|P1|Participant Flow|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
981299|NCT00862186|O2|Outcome|Resource Helpfulness|Fatigue Facts & Fixes was assessed for amount of resource helpfulness on a 1-5 Likert-type scale.
981300|NCT00862186|O1|Outcome|Resource Use|Fatigue Facts & Fixes was assessed for amount of resource use on a 1-5 Likert-type scale.
981301|NCT00862186|E1|Reported Event|Group 1|"'Fatigue Facts & Fixes' is an evidence based educational resource for adolescents with cancer. It is a bright colored laminated 8.5x11 double sided page. One side features information on cancer-related fatigue: Why am I so tired? (description of cancer-related fatigue); What causes fatigue? (contributing factors - environmental, personal/behavioral, cultural/family/other, and treatment-related); and What can help me to not be so tired? (alleviating factors - environmental, personal/behavioral, cultural/family/other, and treatment-related). The other side is a 'Do Not Disturb' sign with a pillow graphic which adolescents can use in the hospital or at home when they need some quiet time and which may also serve to attract their interest to the resource."
981302|NCT00862134|B3|Baseline|Total|Total of all reporting groups
981303|NCT00862134|B2|Baseline|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
981304|NCT00862134|B1|Baseline|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
981305|NCT00862134|P2|Participant Flow|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic Granulocyte Colony-stimulating Factor (G-CSF).
981306|NCT00862134|P1|Participant Flow|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
981307|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
981308|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
981309|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
981310|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
981311|NCT00862134|O2|Outcome|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
981312|NCT00862134|O1|Outcome|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
981313|NCT00862134|E2|Reported Event|PR104 + Docetaxel|Subjects randomized to the PR104/docetaxel arm will be administered 60 mg/m^2 docetaxel, IV, every 21 days plus 770 mg/m^2 PR104, IV, every 21 days and prophylactic G-CSF.
981314|NCT00862134|E1|Reported Event|Docetaxel|75 mg/m^2 docetaxel, IV, every 21 days
981315|NCT00862121|B3|Baseline|Total|Total of all reporting groups
981316|NCT00862121|B2|Baseline|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981317|NCT00862121|B1|Baseline|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981318|NCT00862121|P2|Participant Flow|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981319|NCT00862121|P1|Participant Flow|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981320|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981321|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981322|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981323|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981324|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981325|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981326|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981327|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981328|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981329|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981330|NCT00862121|O2|Outcome|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981331|NCT00862121|O1|Outcome|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981332|NCT00862121|E2|Reported Event|Placebo|Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981333|NCT00862121|E1|Reported Event|Mesalazine|Mesalazine (Mesalamine) 2 g sachet; 6 g daily
981334|NCT00862082|B3|Baseline|Total|Total of all reporting groups
981335|NCT00862082|B2|Baseline|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981336|NCT00862082|B1|Baseline|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981337|NCT00862082|P2|Participant Flow|PR104 770 mg/m^2 + Sorafenib|770 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981338|NCT00862082|P1|Participant Flow|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981339|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
981340|NCT00862082|O5|Outcome|PR104H|activated reduced metabolites
981341|NCT00862082|O4|Outcome|PR104S1|semi-mustard metabolite
981342|NCT00862082|O3|Outcome|PR104G|major plasma metabolite
981343|NCT00862082|O2|Outcome|PR104A|major plasma metabolite
981344|NCT00862082|O1|Outcome|PR104|
981345|NCT00862082|O6|Outcome|PR104M|activated reduced metabolites
981379|NCT00862082|E1|Reported Event|PR104 550 mg/m^2 + Sorafenib|550 mg/m^2 PR104 administered IV every 4 weeks + Standard dose sorafenib (400 mg PO twice daily)
981380|NCT00861913|B1|Baseline|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981381|NCT00861913|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981382|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981383|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981384|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981385|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981386|NCT00861913|O1|Outcome|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981387|NCT00861913|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
981388|NCT00861757|B5|Baseline|Total|Total of all reporting groups
981389|NCT00861757|B4|Baseline|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981390|NCT00861757|B3|Baseline|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981391|NCT00861757|B2|Baseline|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981392|NCT00861757|B1|Baseline|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981393|NCT00861757|P4|Participant Flow|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981394|NCT00861757|P3|Participant Flow|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981395|NCT00861757|P2|Participant Flow|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981396|NCT00861757|P1|Participant Flow|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981397|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981398|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981399|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981400|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981401|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981402|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981403|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981404|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981405|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981406|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981407|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981408|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981409|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981410|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981411|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981412|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981413|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981414|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981415|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981416|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981417|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981418|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981419|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981420|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981421|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981422|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981423|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981424|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981425|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981426|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981427|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981428|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981429|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981776|NCT00861146|B3|Baseline|Total|Total of all reporting groups
981430|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981431|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981432|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981433|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981434|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981435|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981436|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981437|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981438|NCT00861757|O3|Outcome|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981439|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981440|NCT00861757|O1|Outcome|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981441|NCT00861757|O4|Outcome|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30min after meal) for 12 weeks
981442|NCT00861757|O3|Outcome|5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
981443|NCT00861757|O2|Outcome|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30min after meal) for 12 weeks
981444|NCT00861757|O1|Outcome|Placebo|Drug: Placebo PO, QD (30min after meal) for 12 weeks
981445|NCT00861757|E4|Reported Event|0.2 mg Tamsulosin|Drug: Tamsulosin PO, QD (30 min after meal) for 12 weeks
981446|NCT00861757|E3|Reported Event|5.0 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981447|NCT00861757|E2|Reported Event|2.5 mg Tadalafil|Drug: Tadalafil PO, QD (30 min after meal) for 12 weeks
981448|NCT00861757|E1|Reported Event|Placebo|Drug: Placebo by mouth (PO), once daily (QD) (30 min after meal) for 12 weeks
981449|NCT00861744|B5|Baseline|Total|Total of all reporting groups
981450|NCT00861744|B4|Baseline|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981451|NCT00861744|B3|Baseline|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981452|NCT00861744|B2|Baseline|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981453|NCT00861744|B1|Baseline|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981454|NCT00861744|P4|Participant Flow|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981455|NCT00861744|P3|Participant Flow|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981456|NCT00861744|P2|Participant Flow|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981457|NCT00861744|P1|Participant Flow|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981458|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981459|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981460|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981461|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981462|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981463|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981464|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981465|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981466|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981467|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981468|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981469|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981470|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981471|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981472|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981473|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981474|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981475|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981476|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981477|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981478|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981479|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981480|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981481|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981482|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981483|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981484|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981485|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981486|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981487|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981488|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981489|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981490|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981491|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981492|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981493|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981494|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981495|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981496|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981497|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981498|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981499|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981500|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981501|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981502|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981503|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981504|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981505|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981506|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981507|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981508|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981509|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981510|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981511|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981512|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981513|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981514|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981515|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981516|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981517|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981518|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981519|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981520|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981521|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981522|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981523|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981524|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981525|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981526|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981527|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981528|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981529|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981530|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981531|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981532|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981533|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981534|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981535|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981536|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981537|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981538|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981539|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981540|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981541|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981542|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981543|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981544|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981545|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981546|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981547|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981548|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981549|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981550|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981551|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981552|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981553|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981554|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981555|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981556|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981557|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981558|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981559|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981560|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981561|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981562|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981563|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981564|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981565|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981566|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981567|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981568|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981569|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981570|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981571|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981572|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981573|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981574|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981575|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981576|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981577|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981578|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981579|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981580|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981581|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981582|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981583|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981584|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981585|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981586|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981587|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981588|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981589|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981590|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981591|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981592|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981593|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981594|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981595|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981596|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981597|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981598|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981599|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981600|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981601|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981602|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981603|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981604|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981605|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981606|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981607|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981608|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981609|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981610|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981611|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981612|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981613|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981614|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981615|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981616|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981617|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981618|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981619|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981620|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981621|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981622|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981623|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981624|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981625|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981626|NCT00861744|O4|Outcome|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981627|NCT00861744|O3|Outcome|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981628|NCT00861744|O2|Outcome|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981629|NCT00861744|O1|Outcome|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981630|NCT00861744|E4|Reported Event|MMR-II Group|Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981631|NCT00861744|E3|Reported Event|Priorix 3 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981632|NCT00861744|E2|Reported Event|Priorix 2 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981633|NCT00861744|E1|Reported Event|Priorix 1 Group|Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.
981634|NCT00861705|B5|Baseline|Total|Total of all reporting groups
981635|NCT00861705|B4|Baseline|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
981636|NCT00861705|B3|Baseline|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
981637|NCT00861705|B2|Baseline|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
981638|NCT00861705|B1|Baseline|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
981639|NCT00861705|P4|Participant Flow|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1, bev as in arm 2, and carboplatin as in arm 3.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV~carboplatin: Given IV"
981640|NCT00861705|P3|Participant Flow|Arm 3 (Pac + Carboplatin --> ddAC)|"Patients receive pac and ddAC as in arm 1. Patients also receive carboplatin IV over 30 minutes once in weeks 1, 4, 7, and 10.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~carboplatin: Given IV"
981641|NCT00861705|P2|Participant Flow|Arm 2 (Pac + Bev --> ddAC + Bev)|"Patients receive pac and ddAC as in arm 1. Patients also receive bevacizumab (bev) IV over 30-90 minutes in weeks 1, 3, 5, 7, 9, 11, 13, 15, and 17.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
981812|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
981642|NCT00861705|P1|Participant Flow|Arm 1 (Pac --> ddAC)|"Patients receive paclitaxel (pac) IV over 60 minutes once weekly in weeks 1-12. Patients then receive dose-dense doxorubicin hydrochloride IV over 5-10 minutes and cyclophosphamide IV over 5-30 minutes (ddAC) once in weeks 13, 15, 17, and 19.~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~cyclophosphamide: Given IV"
981643|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
981644|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
981645|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
981646|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
981647|NCT00861705|O2|Outcome|Factor B: No Bevacizumab|Factor B is the addition or not of bevacizumab: the control regimens did not include bevacizumab (Arms 1 & 3)
981648|NCT00861705|O1|Outcome|Factor B: Bevacizumab|Factor B is the addition or not of bevacizumab: the experimental regimens included bevacizumab (Arms 2 & 4).
981649|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
981650|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
981651|NCT00861705|O2|Outcome|Factor A: No Carboplatin|Factor A is the addition or not of carboplatin; the control regimens did not include carboplatin (Arms 1 & 2).
981652|NCT00861705|O1|Outcome|Factor A: Carboplatin|Factor A is the addition or not of carboplatin: the experimental regimens included carboplatin (Arms 3 & 4).
981653|NCT00861705|E4|Reported Event|Arm 4 (Pac + Carboplatin + Bev --> ddAC + Bev)|carboplatin: Given IV
981654|NCT00861705|E3|Reported Event|Arm 3 (Pac + Carboplatin --> ddAC)|carboplatin: Given IV
981655|NCT00861705|E2|Reported Event|Arm 2 (Pac + Bev --> ddAC + Bev)|bevacizumab: Given IV
981656|NCT00861705|E1|Reported Event|Arm 1 (Pac --> ddAC)|cyclophosphamide: Given IV
981657|NCT00861692|B1|Baseline|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981658|NCT00861692|P1|Participant Flow|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981659|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981660|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981661|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981662|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981663|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981664|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981665|NCT00861692|O1|Outcome|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981666|NCT00861692|E1|Reported Event|Argatroban|start with 1μg/kg/min infusion to be adjusted to aPTT 1.5-3.0 times the baseline values
981667|NCT00861614|B3|Baseline|Total|Total of all reporting groups
981668|NCT00861614|B2|Baseline|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed PD, drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981669|NCT00861614|B1|Baseline|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4,7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981670|NCT00861614|P2|Participant Flow|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981671|NCT00861614|P1|Participant Flow|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gray units (Gy) to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981672|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981813|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
981814|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
981815|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
981673|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981674|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981675|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981676|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981677|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981678|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981679|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981680|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981681|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981682|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981683|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981684|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981816|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
981685|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981686|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981687|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981688|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981689|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981690|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981691|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981692|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981693|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981694|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981695|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981696|NCT00861614|O2|Outcome|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981817|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
981697|NCT00861614|O1|Outcome|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981698|NCT00861614|E2|Reported Event|Placebo + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, placebo solution (0.9% sodium chloride or 5% dextrose) infused IV over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981699|NCT00861614|E1|Reported Event|Ipilimumab + Radiotherapy|Prior to receiving study drug, participants receive radiotherapy at 8 Gy to at least 1 and up to a maximum of 5, bone fields, all in one day. Within 2 days of radiotherapy, 10 milligrams (mg) of ipilimumab per kilogram (kg) of body weight was administered intravenously (IV) over 90 minutes. During the treatment phase, dosing was at weeks 1, 4, 7 and 10. In the maintenance phase, dosing was a 12-week intervals, beginning at week 24. Dosing continued until confirmed progressive disease (PD), drug intolerance, clinical deterioration, death, withdrawal of consent or subject lost to follow-up.
981700|NCT00861601|B4|Baseline|Total|Total of all reporting groups
981701|NCT00861601|B3|Baseline|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981702|NCT00861601|B2|Baseline|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981703|NCT00861601|B1|Baseline|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981704|NCT00861601|P3|Participant Flow|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981705|NCT00861601|P2|Participant Flow|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981706|NCT00861601|P1|Participant Flow|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981707|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981708|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981709|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981710|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981711|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981712|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981713|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981714|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981715|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981716|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981717|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981718|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981719|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981720|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981721|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981722|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981818|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
981723|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981724|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981725|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981726|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981727|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981728|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981729|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981730|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981731|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981732|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981733|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981734|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981735|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981736|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981737|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981738|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981739|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981740|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981741|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981742|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981743|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981744|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981745|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
981746|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981747|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count &lt;80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981748|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 mg of eltrombopag once daily for 14 days.
981749|NCT00861601|O3|Outcome|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981750|NCT00861601|O2|Outcome|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981751|NCT00861601|O1|Outcome|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981819|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
981752|NCT00861601|E3|Reported Event|Eltrombopag 37.5 mg|Participants received 37.5 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981753|NCT00861601|E2|Reported Event|Eltrombopag 25 mg|Participants received 25 mg of eltrombopag once daily for 14 days. Participants with a platelet count <80 x 10^9/Liter on Day 15 received eltrombopag for an additional week if the participant agreed to it and the investigator considered it appropriate.
981754|NCT00861601|E1|Reported Event|Eltrombopag 12.5 mg|Participants received 12.5 milligrams (mg) of eltrombopag once daily for 14 days.
981755|NCT00861471|B1|Baseline|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981756|NCT00861471|P1|Participant Flow|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981757|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981758|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981759|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981760|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981761|NCT00861471|O1|Outcome|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981762|NCT00861471|E1|Reported Event|Docetaxel +Gleevec|21 days per treatment cycle for up to 1 year: Day 1: Docetaxel (Taxotere) ( 70 mg/m^2 intravenously over 1 hour. Day 2: (24-36 hours later) start Gleevec (Imatinib Mesylate) 600 mg, orally, daily x 14 days
981763|NCT00861341|B1|Baseline|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
981764|NCT00861341|P1|Participant Flow|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
981765|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
981766|NCT00861341|O1|Outcome|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
981767|NCT00861341|E1|Reported Event|Pioglitazone With or Without 81mg Aspirin|Blood samples will be taken at time 0 to measure platelet aggregation. 30mg Pioglitazone will be ingested and another blood sample will be obtained 90-180 minutes later for platelet aggregation. After 6-9 days, subjects will ingest 81mg of aspirin. Another blood sample will be obtained 2-24 hours later for baseline determination of platelet aggregation and activation after taking aspirin. Subjects will then ingest 30mg pioglitazone and a final blood sample will be obtained 90-180 minutes later to measure platelet aggregation.
981768|NCT00861263|B1|Baseline|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
981769|NCT00861263|P1|Participant Flow|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
981770|NCT00861263|O1|Outcome|Spiral Enteroscopy Subjects|All subjects followed up after spiral enteroscopy
981771|NCT00861263|E1|Reported Event|Enteroscopy|Any subject who was referred for an enteroscopy to our facility and an overtube was used at the time of endoscopy was asked to participate in this study.
981772|NCT00861198|B1|Baseline|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
981773|NCT00861198|P1|Participant Flow|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
981774|NCT00861198|O1|Outcome|ERCP With Cholangioscopy and/or Pancretoscopy|Patients underwent ERCP and cholangiography or pancreatography with the Spyglass system.
981775|NCT00861198|E1|Reported Event|ERCP|"Patients who have a medical indication for ERCP with cholangioscopy and/or pancreatoscopy and are referred for the procedure as part of their standard medical care will be considered for the study.~ERCP as per medical indication: ERCP as per medical indication"
981777|NCT00861146|B2|Baseline|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981778|NCT00861146|B1|Baseline|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981779|NCT00861146|P2|Participant Flow|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981780|NCT00861146|P1|Participant Flow|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981781|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981782|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981783|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981784|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981785|NCT00861146|O2|Outcome|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981786|NCT00861146|O1|Outcome|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981787|NCT00861146|E2|Reported Event|2 Deferred Smoking Cessation|"smoking cessation delivered 12 weeks after intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981788|NCT00861146|E1|Reported Event|1 Concurrent Smoking Cessation|"smoking cessation delivered concurrent with intensive alcohol treatment~behavioral counseling plus contingency management: Individual counseling sessions with voucher rewards for smoking abstinence, transdermal nicotine patch and nicotine gum"
981789|NCT00860951|B1|Baseline|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
981790|NCT00860951|P1|Participant Flow|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
981791|NCT00860951|O3|Outcome|Assistive Technology Enironment|Average accuracy of selections for three sessions of text copying with the BCI acting as a keyboard replacement for a communication system.
981792|NCT00860951|O2|Outcome|Computer Environment|Average accuracy of selections for three sessions of text copying within the BCI acting as a keyboard replacement for a laptop computer.
981793|NCT00860951|O1|Outcome|BCI Environment|Average accuracy of selections for three sessions of text copying within the BCI as a stand-alone device.
981794|NCT00860951|E1|Reported Event|Brain Computer Interface Keyboard|"What effect does the environment (BCI, AT device, Computer) have on the accuracy of typing using a BCI keyboard?~Brain Computer Interface Keyboard: Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions."
981795|NCT00860847|B3|Baseline|Total|Total of all reporting groups
981796|NCT00860847|B2|Baseline|Placebo|Patients randomized to placebo
981797|NCT00860847|B1|Baseline|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
981798|NCT00860847|P2|Participant Flow|Placebo|Patients randomized to placebo
981799|NCT00860847|P1|Participant Flow|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
981800|NCT00860847|O2|Outcome|Placebo|Patients randomized to placebo
981801|NCT00860847|O1|Outcome|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
981802|NCT00860847|E2|Reported Event|Placebo|Patients randomized to placebo
981803|NCT00860847|E1|Reported Event|Aged Garlic Extract and Coenzyme Q10|Patients randomized to oral AGE (1200 mg) and CoQ10 (120 mg)
981804|NCT00860795|B3|Baseline|Total|Total of all reporting groups
981805|NCT00860795|B2|Baseline|Placebo|25 ml daily in 2 divided doses for 10 days
981806|NCT00860795|B1|Baseline|Echinacea|25 ml daily in 2 divided doses for 10 days
981807|NCT00860795|P2|Participant Flow|Placebo|25 ml daily in 2 divided doses for 10 days
981808|NCT00860795|P1|Participant Flow|Echinacea|25 ml daily in 2 divided doses for 10 days
981809|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
981810|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
981811|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
981820|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
981821|NCT00860795|O2|Outcome|Placebo|25 ml daily in 2 divided doses for 10 days
981822|NCT00860795|O1|Outcome|Echinacea|25 ml daily in 2 divided doses for 10 days
981823|NCT00860795|E2|Reported Event|Placebo|25 ml daily in 2 divided doses for 10 days
981824|NCT00860795|E1|Reported Event|Echinacea|25 ml daily in 2 divided doses for 10 days
981825|NCT00860743|B7|Baseline|Total|Total of all reporting groups
981826|NCT00860743|B6|Baseline|Aim 2 - Healthy - Hypoxia - Antioxidant/Placebo|We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.
981827|NCT00860743|B5|Baseline|Aim 2 - OSA - Hypoxia - Antioxidant/Placebo|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
981828|NCT00860743|B4|Baseline|Aim 1 - Healthy Females- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
981829|NCT00860743|B3|Baseline|Aim 1 - Healthy Males- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 healthy males. These males will be matched with 10 OSA males and 10 OSA females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
981830|NCT00860743|B2|Baseline|Aim 1 - OSA Female- Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA females. These females will be matched with 10 males with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
981831|NCT00860743|B1|Baseline|Aim 1 - OSA Male - Sleep/Wake - Hypoxia/Sham|"We plan to study 10 OSA males. These males will be matched with 10 females with moderate obstructive sleep apnea (OSA), 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
981832|NCT00860743|P2|Participant Flow|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
981833|NCT00860743|P1|Participant Flow|OSA/Healthy - Males/Females - Wake/Sleep|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
981834|NCT00860743|O1|Outcome|OSA/HEALTHY - HYPOXIA - ANTIOXIDANT/PLACEBO|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
981835|NCT00860743|O1|Outcome|OSA/HEALTHY - MALES/FEMALES - WAKE/SLEEP|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
981836|NCT00860743|E2|Reported Event|Arm 2|"We plan to study 10 male participants with moderate obstructive sleep apnea (OSA) and 10 male control participants matched for age, race and body mass index. The OSA and control participants will be exposed to intermittent hypoxia during wakefulness and sleep following administration of an antioxidant or a placebo cocktail that will be presented in a randomized fashion.~Antioxidant cocktail: 120 mg of Coenzyme Q10 (orally), 800 mg of Superoxide Dismutase (orally), 400 IU of Vitamin E (orally) before exposure to intermittent hypoxia. Two doses of 1 g of Vitamin C in 50 cc of saline IV (in the vein) before and after exposure to intermittent hypoxia."
981837|NCT00860743|E1|Reported Event|Arm 1|"We plan to study 10 males and 10 females with moderate obstructive sleep apnea (OSA), and 10 healthy males and 10 healthy females. The males and the females will be matched based on age, race, sex and body mass index. The OSA and control participants will be exposed to intermittent hypoxia and sham intermittent hypoxia during wakefulness and sleep."
981838|NCT00860535|B1|Baseline|Ph+ CML or Ph+ ALL|Growth Factor Signature (GFS) biomarker evaluation in participants with blast phase Ph+ CML or Ph+ ALL who were treated with imatinib, dasatinib or nilotinib as per standard of care.
981839|NCT00860535|P1|Participant Flow|Ph+ CML or Ph+ ALL|Participants with blast phase Philadelphia Chromosomes Positive (Ph+) Chronic Myelogenous Leukemia (CML) or Philadelphia Chromosome Positive (Ph+) Acute Lymphocytic Leukemia (ALL) who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
981840|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
981841|NCT00860535|O1|Outcome|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care. All participants who had evaluable gene expression data were included in the analysis.
981842|NCT00860535|E1|Reported Event|Ph+ CML or Ph+ ALL|Participants with blast phase Ph+ CML or Ph+ ALL who were beginning treatment with imatinib, dasatinib or nilotinib as per standard of care.
981843|NCT00860470|B3|Baseline|Total|Total of all reporting groups
981844|NCT00860470|B2|Baseline|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981845|NCT00860470|B1|Baseline|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981846|NCT00860470|P2|Participant Flow|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981847|NCT00860470|P1|Participant Flow|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981848|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981849|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981850|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981851|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981852|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981853|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981854|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981855|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981856|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981857|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981858|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981859|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981860|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981861|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981862|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981863|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981864|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981865|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981866|NCT00860470|O2|Outcome|Multiple Micronutrient|"Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981867|NCT00860470|O1|Outcome|Iron and Folate|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981868|NCT00860470|E2|Reported Event|Multiple Micronutrient|"Multiple micronutrient~Multiple micronutrient: Containing 15 micronutrients all at an RDA including: vitamin A (770 ug retinol equivalents, vitamin D (5 ug), vitamin E (15 mg), folic acid (600 ug), thiamin (1.4 mg), riboflavin (1.4 mg), niacin (18 mg), vitamin B-12 (2.6 mg), vitamin B-6 (1.9 mg), vitamin C (85 mg), iron (27 mg), zinc (12 mg), iodine (220 ug), copper (1000 ug), selenium (60 ug).~Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981869|NCT00860470|E1|Reported Event|Iron (27 mg) and Folic Acid (600 ug)|"Iron (27 mg) and folic acid (600 ug)~Iron (27 mg) - folic acid (600 ug): Supplement serves as the Control (providing the current standard of care during pregnancy). Mothers instructed to take 1 tablet per day, from the 1st trimester through 12 weeks post-partum."
981870|NCT00860457|B1|Baseline|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
981871|NCT00860457|P1|Participant Flow|Chemotherapy|Fludarabine/Rituximab followed by Lenalidomide
981872|NCT00860457|O1|Outcome|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
981873|NCT00860457|E1|Reported Event|Chemotherapy|"Fludarabine/Rituximab followed by Lenalidomide~Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles~Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles~Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles"
981874|NCT00860405|B3|Baseline|Total|Total of all reporting groups
981875|NCT00860405|B2|Baseline|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981876|NCT00860405|B1|Baseline|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981877|NCT00860405|P2|Participant Flow|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981878|NCT00860405|P1|Participant Flow|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981879|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981880|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981881|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981882|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981883|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981884|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981885|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981886|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981887|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981888|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981889|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981890|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981891|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981892|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981893|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981894|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981895|NCT00860405|O2|Outcome|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981896|NCT00860405|O1|Outcome|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981897|NCT00860405|E2|Reported Event|HSA 5% Arm (Comparison Group)|Human Serum Albumin (HSA) 50g/L, i.v.
981898|NCT00860405|E1|Reported Event|Voluven® Arm|6% Hydroxyethylstarch 130/0.4, i.v. Voluven® rates were not to exceed 50 mL/kg/day; if additional study drug was required, 5% HSA was provided as rescue colloid.
981899|NCT00860314|B3|Baseline|Total|Total of all reporting groups
981900|NCT00860314|B2|Baseline|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
981901|NCT00860314|B1|Baseline|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
981902|NCT00860314|P2|Participant Flow|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
981903|NCT00860314|P1|Participant Flow|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
981904|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
981905|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
981906|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
981907|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
981908|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
981909|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
981910|NCT00860314|O2|Outcome|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
981911|NCT00860314|O1|Outcome|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
981912|NCT00860314|E2|Reported Event|Antero-Lateral Group|Cardioversion with antero-lateral electrode position
981913|NCT00860314|E1|Reported Event|Antero-Posterior Group|Cardioversion with antero-posterior electrode position
981914|NCT00860262|B4|Baseline|Total|Total of all reporting groups
981915|NCT00860262|B3|Baseline|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981916|NCT00860262|B2|Baseline|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981917|NCT00860262|B1|Baseline|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981918|NCT00860262|P3|Participant Flow|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981919|NCT00860262|P2|Participant Flow|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981920|NCT00860262|P1|Participant Flow|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981921|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981922|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981923|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981924|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981925|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981926|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981927|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981928|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981929|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981930|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981931|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981932|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981933|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981934|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981935|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981936|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981937|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981938|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981939|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981940|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981941|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981942|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981943|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981944|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981945|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981946|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981947|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981948|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981949|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981950|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981951|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981952|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981953|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981954|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981955|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981956|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981957|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981958|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981959|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981960|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981961|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981962|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981963|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
981964|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981965|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
981966|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981967|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981968|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981969|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981970|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981971|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981972|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981973|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981974|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981975|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981976|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981977|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981978|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981979|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981980|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981981|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981982|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981983|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981984|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981985|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981986|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981987|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981988|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981989|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981990|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981991|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981992|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981993|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981994|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981995|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981996|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
981997|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
981998|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
981999|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
982000|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982001|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
982002|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
982003|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982004|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
982005|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
982006|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982007|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
982008|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
982009|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982010|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
982011|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
982012|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982013|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
982014|NCT00860262|O3|Outcome|Amlodipine 5 mg|Amlodipine 5 mg once daily (A5)
982015|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982016|NCT00860262|O1|Outcome|T80+A5|Telmisartan 80 mg plus Amlodipine 5 mg once daily (T80+A5)
982017|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
982018|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982019|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
982020|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
982021|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982022|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
982023|NCT00860262|O3|Outcome|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
982024|NCT00860262|O2|Outcome|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982025|NCT00860262|O1|Outcome|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
982026|NCT00860262|E3|Reported Event|Amlodipine 10 mg|Amlodipine 10 mg once daily (A10)
982027|NCT00860262|E2|Reported Event|Telmisartan 80 mg|Telmisartan 80 mg once daily (T80)
982028|NCT00860262|E1|Reported Event|T80+A10|Telmisartan 80 mg plus Amlodipine 10 mg once daily (T80+A10)
982029|NCT00860249|B4|Baseline|Total|Total of all reporting groups
982030|NCT00860249|B3|Baseline|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
982031|NCT00860249|B2|Baseline|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
982032|NCT00860249|B1|Baseline|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
982033|NCT00860249|P3|Participant Flow|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
982034|NCT00860249|P2|Participant Flow|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
982035|NCT00860249|P1|Participant Flow|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
982036|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
982037|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
982038|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
982039|NCT00860249|O3|Outcome|Behavioral: Letter and Educational DVD|Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
982040|NCT00860249|O2|Outcome|Behavioral: Letter Only|Participants in this arm will receive a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
982041|NCT00860249|O1|Outcome|Usual Care|Usual Care - participants receive usual care
982042|NCT00860249|E3|Reported Event|Behavioral: Letter and Educational DVD|Behavioral: Letter and Educational DVD Participants will get a letter from their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening. It will be accompanied by an educational DVD about the screening. The participants will receive this prior to a scheduled upcoming appointment with their physician.
982043|NCT00860249|E2|Reported Event|Behavioral: Letter Only|Behavioral: Letter Only Prior to a scheduled upcoming appointment, participants will get a letter signed by their physician that provides brief information about colorectal cancer (CRC) and notes the importance of CRC screening.
982044|NCT00860249|E1|Reported Event|Usual Care|Usual Care. Participants in this arm will receive usual care until outcome assessment is performed at 6 months following randomization. At that time, they will be sent a letter reminding them to obtain the ordered preventative service test.
982045|NCT00860158|B1|Baseline|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982046|NCT00860158|P1|Participant Flow|Experimental Arm|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982047|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982164|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
982165|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982048|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982049|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982050|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982051|NCT00860158|O1|Outcome|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982052|NCT00860158|E1|Reported Event|Single Arm Assignment|"Neoadjuvant dasatinib plus leuprolide acetate followed by radical prostatectomy~Dasatinib: Dasatinib 100 mg administered once daily per oral route for 28 consecutive days~Leuprolide Acetate (LHRH Analogue): Leuprolide acetate 7.5 mg administered subcutaneously on day 1 every 28 days (+ 7 days).~Radical Prostatectomy: Radical prostatectomy should be performed no sooner than 8 hours but preferably within 24 hours of the last administered dasatinib dose."
982053|NCT00860067|B4|Baseline|Total|Total of all reporting groups
982054|NCT00860067|B3|Baseline|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982055|NCT00860067|B2|Baseline|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982056|NCT00860067|B1|Baseline|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982057|NCT00860067|P3|Participant Flow|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982058|NCT00860067|P2|Participant Flow|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982059|NCT00860067|P1|Participant Flow|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982060|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982061|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982062|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982063|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982064|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982166|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982065|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982066|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982067|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982068|NCT00860067|O2|Outcome|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982069|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982070|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982071|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982072|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982073|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982074|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982075|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982076|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982077|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982078|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982079|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982080|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982167|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
982246|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
982081|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982082|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982083|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982084|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982085|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982086|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982087|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982088|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982089|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982090|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982091|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982092|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982093|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982094|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982095|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982096|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982097|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982098|NCT00860067|O2|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982099|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982100|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982101|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982102|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982103|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982104|NCT00860067|O2|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982105|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982106|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982107|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982108|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982109|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982110|NCT00860067|O4|Outcome|All FluMist|All FluMist group for A/H1N1 and A/H3N2 strains, where data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982111|NCT00860067|O3|Outcome|FluMist/B/Victoria|FluMist/B/Victoria(trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Victoria [B/Malaysia/2506/2004]).
982112|NCT00860067|O2|Outcome|FluMist/B/Yamagata|FluMist/B/Yamagata (trivalent influenza vaccine) was supplied in the BD Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 FFU of each of 3 temperate sensitive, cold-adapted, attentuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], and B/Yamagata [B/Florida/4/2006]).
982113|NCT00860067|O1|Outcome|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982114|NCT00860067|E2|Reported Event|All FluMist|Data from both the FluMist/B/Yamagata arm and the FluMist/B/Victoria arm were combined.
982168|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982115|NCT00860067|E1|Reported Event|Q/LAIV (MEDI3250)|Q/LAIV (quadrivalent influenza vaccine) (MEDI3250) was supplied in the Becton Dickinson (BD) Accuspray device that delivers a 0.2 mL total volume intranasal dose divided into each nostril (ie, administered as 0.1 mL per nostril). Each 0.2 mL dose contained 10^7.0 ± 0.5 fluorescent focus units (FFU) of each of 4 temperature sensitive, cold-adapted, attenuated, 6:2 reassortant influenza strains (A/H1N1 [A/South Dakota/6/2007], A/H3N2 [A/Uruguay/716/2007], B/Victoria [B/Malaysia/2506/2004], and B/Yamagata [B/Florida/4/2006]).
982116|NCT00860028|B3|Baseline|Total|Total of all reporting groups
982117|NCT00860028|B2|Baseline|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
982118|NCT00860028|B1|Baseline|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
982119|NCT00860028|P2|Participant Flow|Placebo Pretreatment/Varenicline Treatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
982120|NCT00860028|P1|Participant Flow|Varenicline Pretreatment/Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment.
982121|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date
982122|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
982123|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
982124|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date.
982125|NCT00860028|O2|Outcome|Short-term Varenicline Pretreatment|Arm 2 (Experimental) = 3 weeks placebo + 1 week varenicline (Chantix)pretreatment + 4 weeks varenicline 1 mg oral tablet twice per day treatment following the smoking quit date.
982126|NCT00860028|O1|Outcome|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 4 weeks varenicline (Chantix) titrated to 1 mg oral tablet twice per day pretreatment + 4 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment following the smoking quit date
982127|NCT00860028|E2|Reported Event|Short Varenicline Pretreatment (Placebo)|Arm 2 (Experimental) = 3 weeks placebo pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
982128|NCT00860028|E1|Reported Event|Extended Varenicline Pretreatment|Arm 1 (Experimental) = 3 weeks varenicline (Chantix) 1 mg oral tablet twice per day pretreatment + 5 weeks varenicline (Chantix) 1 mg oral tablet twice per day treatment
982129|NCT00859950|B3|Baseline|Total|Total of all reporting groups
982130|NCT00859950|B2|Baseline|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
982131|NCT00859950|B1|Baseline|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
982132|NCT00859950|P2|Participant Flow|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
982133|NCT00859950|P1|Participant Flow|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
982134|NCT00859950|O2|Outcome|Normal Control|Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.
982135|NCT00859950|O1|Outcome|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw."
982169|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982170|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
982171|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982247|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
982136|NCT00859950|E2|Reported Event|Sleep Apnea|"Subjects found to have Obstructive Sleep Apnea (OSA) with Intermittent Hypoxemia (IH). This arm will undergo a pre-treatment blood draw, one month of Continuous Positive Airway Pressure (CPAP) to treat OSA, and a post-treatment blood draw.~Continuous Positive Airway Pressure (CPAP): Continuous positive airway pressure (CPAP) is a method of respiratory ventilation which is accepted as the gold standard to treat Obstructive Sleep Apnea (OSA). Subjects found to have OSA after the Nocturnal Polysomnography (NPSG) will be trained in the use of CPAP and will be instructed to use CPAP every night for 30 nights. These subjects will then return for a post-treatment blood draw.~Serious and Other [Not Including Serious] Adverse Events were not observed."
982137|NCT00859950|E1|Reported Event|Normal Control|"Subject found to have no evidence of Obstructive Sleep Apnea (OSA) after Nocturnal Polysomnography (NPSG). These subjects will only undergo a blood draw and will not have the Continuous Positive Airway Pressure (CPAP) treatment.~Serious and Other [Not Including Serious] Adverse Events were not observed."
982138|NCT00859937|B3|Baseline|Total|Total of all reporting groups
982139|NCT00859937|B2|Baseline|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982140|NCT00859937|B1|Baseline|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982141|NCT00859937|P2|Participant Flow|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982142|NCT00859937|P1|Participant Flow|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982143|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982144|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982145|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982146|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982147|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982148|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982149|NCT00859937|O2|Outcome|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982150|NCT00859937|O1|Outcome|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982151|NCT00859937|E2|Reported Event|Non Adenoid Cystic Carcinoma|Patients with non Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982152|NCT00859937|E1|Reported Event|Adenoid Cystic Carcinoma|Patients with Adenoid cystic carcinoma of malignant salivary gland tumors receive oral dasatinib (70mg) twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
982153|NCT00859898|B4|Baseline|Total|Total of all reporting groups
982154|NCT00859898|B3|Baseline|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982155|NCT00859898|B2|Baseline|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
982156|NCT00859898|B1|Baseline|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982157|NCT00859898|P3|Participant Flow|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982158|NCT00859898|P2|Participant Flow|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks.~Placebo: Metformin hydrochloride (HCl) Modified Release matching placebo tablets, once daily, 24 weeks."
982159|NCT00859898|P1|Participant Flow|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982160|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982161|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
982162|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982163|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982248|NCT00859508|B3|Baseline|Total|Total of all reporting groups
982172|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982173|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
982174|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982175|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982176|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
982177|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982178|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982179|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
982180|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982181|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982182|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
982183|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982184|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982185|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
982186|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982187|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982188|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks"
982189|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982190|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982191|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
982192|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982193|NCT00859898|O3|Outcome|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982194|NCT00859898|O2|Outcome|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
982195|NCT00859898|O1|Outcome|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982196|NCT00859898|E3|Reported Event|Metformin XR|"Metformin XR: Tablets, Oral, 500 mg up to 2000 mg, once daily 24 weeks~Placebo: Dapagliflozin matching placebo tablets once daily, 24 weeks"
982197|NCT00859898|E2|Reported Event|Dapagliflozin + Metformin XR|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Metformin XR: Tablets, Oral, up to 2000 mg, once daily, 24 weeks"
982198|NCT00859898|E1|Reported Event|Dapagliflozin|"Dapagliflozin: Tablets, Oral, 10 mg, once daily, 24 weeks~Placebo: Metformin HCl Modified Release matching placebo tablets, once daily, 24 weeks."
982199|NCT00859833|B1|Baseline|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
982200|NCT00859833|P1|Participant Flow|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson was given (0.4 mg) given as in i.v. bolus.
982201|NCT00859833|O2|Outcome|Regadenoson|Regadenoson 0.5 mg i.v. bolus.
982202|NCT00859833|O1|Outcome|Adenosine|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes).
982203|NCT00859833|E1|Reported Event|Adenosine Followed by Regadenoson|Myocardial perfusion reserve measured during adenosine infusion (140 ug/kg/min x 6 minutes). 30 minutes later regadenoson 0.4 mg given intravenous bolus.
982204|NCT00859638|B3|Baseline|Total|Total of all reporting groups
982205|NCT00859638|B2|Baseline|Case Matched Controls|Usual care in primary health care.
982206|NCT00859638|B1|Baseline|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
982207|NCT00859638|P2|Participant Flow|Case Matched Controls|Usual care in primary health care.
982208|NCT00859638|P1|Participant Flow|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
982209|NCT00859638|O2|Outcome|Case Matched Controls|Usual care in primary health care.
982210|NCT00859638|O1|Outcome|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
982211|NCT00859638|E2|Reported Event|Case Matched Controls|Usual care in primary health care.
982212|NCT00859638|E1|Reported Event|Intervention Group|Rehabilitation self-management group, on-line self monitoring of physical function, and organizational capacity building.
982213|NCT00859586|B1|Baseline|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
982214|NCT00859586|P1|Participant Flow|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
982215|NCT00859586|O1|Outcome|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
982216|NCT00859586|E1|Reported Event|Miltenyi Magnetic Cell Sorter for CD3|"Miltenyi Magnetic cell sorter device will be used for CD3 selection of granulocyte colony stimulating factor mobilized allogeneic PBSCT. In stage 1, subjects will receive 1 x 10 to the eight power CD3 cells/kg. In stage II, the dose of CD3+ cells will be increased to 2 x 10 to the eight power cells/kg.~This phase II clinical trial is designed to evaluate a novel non-myeloablative but highly immunosuppressive disease specific conditioning regimen and infusion of unmanipulated lymphocytes from a haplo-identical familial donor in subjects with relapsed disease following matched sibling stem cell transplantation who are not candidates for alternative treatment options. The clinical trial will evaluate recipient survival at six months post-relapse of disease."
982217|NCT00859573|B3|Baseline|Total|Total of all reporting groups
982218|NCT00859573|B2|Baseline|Placebo|Two placebo tablets orally once daily
982219|NCT00859573|B1|Baseline|Modafinil|Modafinil 400mg orally once daily
982220|NCT00859573|P2|Participant Flow|Placebo|Two placebo tablets orally once daily
982221|NCT00859573|P1|Participant Flow|Modafinil|Modafinil 400mg orally once daily
982222|NCT00859573|O2|Outcome|Modafinil|Modafinil 400mg orally daily
982223|NCT00859573|O1|Outcome|Placebo|Participants received 2 capsules placebo orally daily
982224|NCT00859573|E2|Reported Event|Placebo|Two placebo tablets orally once daily
982225|NCT00859573|E1|Reported Event|Modafinil|Modafinil 400mg orally once daily
982226|NCT00859547|B1|Baseline|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982227|NCT00859547|P1|Participant Flow|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982228|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982229|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982230|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982231|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982232|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982233|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982234|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982235|NCT00859547|O1|Outcome|rThrombin, 1000 IU/mL|Recombinant thrombin (rThrombin), 1000 IU/mL, applied topically during a single surgery procedure on Day 1.
982236|NCT00859547|E1|Reported Event|TOTAL|
982237|NCT00859521|B3|Baseline|Total|Total of all reporting groups
982238|NCT00859521|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
982239|NCT00859521|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
982240|NCT00859521|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
982241|NCT00859521|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
982242|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
982243|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
982244|NCT00859521|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
982245|NCT00859521|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
982249|NCT00859508|B2|Baseline|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
982250|NCT00859508|B1|Baseline|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
982251|NCT00859508|P2|Participant Flow|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
982252|NCT00859508|P1|Participant Flow|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
982253|NCT00859508|O2|Outcome|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
982254|NCT00859508|O1|Outcome|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
982255|NCT00859508|E2|Reported Event|Other FDA Cleared Dura Replacements|The Control group consists of other dura replacements that have been cleared for marketing by the FDA, including: Duraform Dural Graft Implant, Duragen II Dural Regeneration Matrix, Duragen Dural Graft Matrix, and Durepair Dura regeneration Matrix.
982256|NCT00859508|E1|Reported Event|SyntheCel|The investigational group consists of patients who received the SyntheCel Dura Replacement device.
982257|NCT00859469|B1|Baseline|Oxaliplatin and Gemcitabine|
982258|NCT00859469|P1|Participant Flow|Oxaliplatin and Gemcitabine|
982259|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
982260|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
982261|NCT00859469|O1|Outcome|Oxaliplatin and Gemcitabine|
982262|NCT00859469|E1|Reported Event|Oxaliplatin and Gemcitabine|
982263|NCT00859430|B3|Baseline|Total|Total of all reporting groups
982264|NCT00859430|B2|Baseline|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
982265|NCT00859430|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
982266|NCT00859430|P2|Participant Flow|Keppra® (Reference) First|Keppra® 1000 mg Tablet (reference) dosed in first period followed by Levetiracetam 1000 mg Tablet (test) dosed in second period
982267|NCT00859430|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 1000 mg Tablet (test) dosed in first period followed by Keppra® 1000 mg Tablet (reference) dosed in second period
982268|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
982269|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
982270|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
982271|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
982272|NCT00859430|O2|Outcome|Keppra®|Keppra® 1000 mg Tablet (reference) dosed in either period
982273|NCT00859430|O1|Outcome|Levetiracetam|Levetiracetam 1000 mg Tablet (test) dosed in either period
982274|NCT00859339|B1|Baseline|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982275|NCT00859339|P1|Participant Flow|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982276|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982277|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982278|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982279|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982280|NCT00859339|O1|Outcome|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982281|NCT00859339|E1|Reported Event|CGS + Radical Cystectomy|"Neoadjuvant cisplatin, gemcitabine and sunitinib malate followed by radical cystectomy~Gemcitabine: Gemcitabine ( 1000 mg/m2) IV days 1 and 8~Cisplatin: Cisplatin (70 mg/m2) IV day 1~Sunitinib Malate: Sunitinib malate (37.5 mg) oral daily for days 1-14~Radical Cystectomy: Radical cystectomy performed no sooner than 2 weeks but within 6 weeks of the last dose of sunitinib malate."
982282|NCT00859313|B1|Baseline|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
982283|NCT00859313|P1|Participant Flow|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
982284|NCT00859313|O1|Outcome|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
982285|NCT00859313|E1|Reported Event|Sufentanil NanoTab PCA System/15 Mcg|15 mcg Sufentanil NanoTab taken sublingually q 20 minutes as needed for 12 hours
982286|NCT00859222|B4|Baseline|Total|Total of all reporting groups
982287|NCT00859222|B3|Baseline|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982288|NCT00859222|B2|Baseline|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982289|NCT00859222|B1|Baseline|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
982290|NCT00859222|P5|Participant Flow|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982291|NCT00859222|P4|Participant Flow|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982292|NCT00859222|P3|Participant Flow|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982293|NCT00859222|P2|Participant Flow|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982294|NCT00859222|P1|Participant Flow|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
982295|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
982296|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982297|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982298|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
982299|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
982300|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982301|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982302|NCT00859222|O5|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982325|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982581|NCT00858442|B1|Baseline|Without PRP|Patients with burns sequelae on their limbs treated with release of burns contractures and skin graft between 2008-2010.
982303|NCT00859222|O4|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982304|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982305|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982306|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
982307|NCT00859222|O2|Outcome|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982308|NCT00859222|O1|Outcome|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982309|NCT00859222|O3|Outcome|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982310|NCT00859222|O2|Outcome|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982311|NCT00859222|O1|Outcome|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
982312|NCT00859222|O1|Outcome|All Phase I Participants|All phase I participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 according to the established dose escalation schedule.
982313|NCT00859222|E5|Reported Event|Phase II AG: Bevacizumab + LBH589 30 mg Every Other Week|Phase II Anaplastic Glioma (AG) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982314|NCT00859222|E4|Reported Event|Phase II GBM: Bevacizumab + LBH589 30 mg Every Other Week|Phase II glioblastoma (GBM) participants received the regimen established in the Phase I study (Feb 2011). Phase II participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982315|NCT00859222|E3|Reported Event|Phase I Cohort 3: Bevacizumab + LBH589 30 mg Every Other Week|Phase I Cohort 3 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and LBH589 30 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982316|NCT00859222|E2|Reported Event|Phase I Cohort 2: Bevacizumab + LBH589 20 mg Every Other Week|Phase I Cohort 2 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the amended starting LBH589 dose of 20 mg/day orally, 3x per week, every other week (Days 1, 3, 5, 15, 17, 19). Participants were treated until disease progression or unacceptable toxicity.
982317|NCT00859222|E1|Reported Event|Phase I Cohort 1: Bevacizumab +LBH589 20 mg Every Week|Phase I Cohort 1 participants received bevacizumab 10 mg/kg intravenously (IV) on days 1 and 15 of each 28 day cycle and the original starting LBH589 dose of 20 mg/day orally, 3x per week, every week (days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26). Participants were treated until disease progression or unacceptable toxicity.
982318|NCT00859131|B3|Baseline|Total|Total of all reporting groups
982319|NCT00859131|B2|Baseline|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982320|NCT00859131|B1|Baseline|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982321|NCT00859131|P2|Participant Flow|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982322|NCT00859131|P1|Participant Flow|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982323|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982324|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982326|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982327|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982328|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982329|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982330|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982331|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982332|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982333|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982334|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982335|NCT00859131|O2|Outcome|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982336|NCT00859131|O1|Outcome|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982337|NCT00859131|E2|Reported Event|Zenapax|"subject who will receive daclizumab or basiliximab as induction agent in renal transplantation~Daclizumab: 1.0 mg/kg pre-op and 1.0 mg/kg on Day 7"
982338|NCT00859131|E1|Reported Event|Thymoglobulin|"Subjects receiving Thymoglobulin as induction agent in renal transplantation~Rabbit Antithymocyte globulin: 1.5 mg/kg IV pre-op, day 1, day 2, day 3, day 4"
982339|NCT00859053|B5|Baseline|Total|Total of all reporting groups
982340|NCT00859053|B4|Baseline|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982341|NCT00859053|B3|Baseline|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982342|NCT00859053|B2|Baseline|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982343|NCT00859053|B1|Baseline|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982344|NCT00859053|P4|Participant Flow|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982345|NCT00859053|P3|Participant Flow|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982346|NCT00859053|P2|Participant Flow|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982347|NCT00859053|P1|Participant Flow|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 milligrams (mg) (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982348|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982349|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982350|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982351|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982352|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982353|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982354|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982355|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982356|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982357|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982358|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982359|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982360|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982583|NCT00858442|P1|Participant Flow|Without PRP|This arm did not receive any intervention
982361|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982362|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982363|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982364|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982365|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982366|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982367|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982368|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982369|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982370|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982371|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982372|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982373|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982374|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982375|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982376|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982377|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982378|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982379|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982380|NCT00859053|O4|Outcome|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982381|NCT00859053|O3|Outcome|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982382|NCT00859053|O2|Outcome|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982383|NCT00859053|O1|Outcome|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982384|NCT00859053|E4|Reported Event|Healthy Participants|Healthy participants were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982385|NCT00859053|E3|Reported Event|Child Pugh Class-C|Participants with severe liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982386|NCT00859053|E2|Reported Event|Child Pugh Class-B|Participants with moderate liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982387|NCT00859053|E1|Reported Event|Child Pugh Class-A|Participants with mild liver damage were administered with single oral dose of 30 mg (3 x 10 mg capsules) of BMS-790052 after 10 hours overnight fasting.
982388|NCT00859040|B3|Baseline|Total|Total of all reporting groups
982389|NCT00859040|B2|Baseline|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982390|NCT00859040|B1|Baseline|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982391|NCT00859040|P2|Participant Flow|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982392|NCT00859040|P1|Participant Flow|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982393|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982582|NCT00858442|P2|Participant Flow|With PRP|4 cc of PRP is evenly distributed before the dermo-epidermic draft.
982394|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982395|NCT00859040|O1|Outcome|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
982396|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982397|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982398|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982399|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982400|NCT00859040|O2|Outcome|Participants With Benign Meningiomas|participants with benign meningiomas (WHO grade 1) or meningiomas with undetermined histology: patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982401|NCT00859040|O1|Outcome|Participants With Atypical/Malignant Meningiomas|participants with atypical meningiomas (WHO grade 2) or malignant meningiomas (WHO grade 3): patients receive SOM230C (pasireotide LAR) 60 mg intramuscular injections in the buttocks every 28 days
982402|NCT00859040|E1|Reported Event|SOM230C|"Monthly SOM230C (pasireotide LAR) - 60 mg intramuscularly (Single-Arm Trial)~SOM230C: Injection in the buttocks every 28 days"
982403|NCT00859027|B3|Baseline|Total|Total of all reporting groups
982404|NCT00859027|B2|Baseline|Calcium and Vitamin D|
982405|NCT00859027|B1|Baseline|Risedronate Plus Calcium and Vit D|
982406|NCT00859027|P2|Participant Flow|Calcium and Vitamin D Daily (Placebo Group)|
982407|NCT00859027|P1|Participant Flow|Risedronate 35 mg p.o.Every Week Plus Calcium and Vit D Daily|
982408|NCT00859027|O2|Outcome|Calcium and Vitamin D-Spine|
982409|NCT00859027|O1|Outcome|Risedronate - Spine|
982410|NCT00859027|E2|Reported Event|Risedronate|Particiapnts given 35 mg by mouth every week
982411|NCT00859027|E1|Reported Event|CAlcium and Vitamin D|
982412|NCT00859014|B1|Baseline|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
982413|NCT00859014|P1|Participant Flow|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
982414|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
982415|NCT00859014|O1|Outcome|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
982416|NCT00859014|E1|Reported Event|Autologous Bone Marrow Mononuclear Cells|Harvest of bone marrow from ischemic stroke patients, isolation and purification of mono-nuclear cell fraction from bone marrow, intravenous administration of autologous bone marrow mono-nuclear cells with a targeted dose of 10 million cells / kg.
982417|NCT00858962|B1|Baseline|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
982418|NCT00858962|P1|Participant Flow|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
982419|NCT00858962|O1|Outcome|Raltegravir (400mg Twice Per Day)|Subjects were maintained on Buprenorphine/Naloxone (BUP/NLX) for 3 weeks prior to Raltegravir administration to achieve steady state during baseline. Subsequently, subjects were co-administered raltegravir (400mg twice per day)and BUP/NLX. All subjects received 16/4 mg of BUP/NLX daily, except for 1 patient who received 32/8 mg daily.
982420|NCT00858962|E1|Reported Event|Bup/Ral|HIV negative subjects currently enrolled in Buprenorphine maintenance therapy on a stable dose of BUP for at least 3 weeks were admitted to the HRU for PK sampling at intervals over a 24 hour period. Subjects then received RAL and BUP co-administration for a minimum of 4 days after which a second series of blood draws at intervals over a 24 hour period were conducted.
982421|NCT00858858|B1|Baseline|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
982539|NCT00858637|P3|Participant Flow|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982422|NCT00858858|P1|Participant Flow|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
982423|NCT00858858|O1|Outcome|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
982424|NCT00858858|E1|Reported Event|Arm 1|Esophageal biopsy: After the esophageal perfusions described above, 12 biopsy specimens of the squamous epithelium will be taken at a level 2 cm proximal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses. In patients with Barrett's esophagus, 12 biopsy specimens of the specialized intestinal metaplasia also will be taken at a level 1 cm distal to the squamocolumnar junction at baseline (6 biopsies will be used to establish primary cell cultures and six will be used for molecular analyses); 6 more biopsy specimens will be taken at the same level immediately after bile acid perfusion for molecular analyses.
982425|NCT00858845|B1|Baseline|Clonidine Patch|Participants will wear a clonidine patch.
982426|NCT00858845|P1|Participant Flow|Clonidine Patch|Participants will wear a clonidine patch.
982427|NCT00858845|O1|Outcome|Clonidine Patch|Participants will wear a clonidine patch.
982428|NCT00858845|E1|Reported Event|Clonidine Patch|Participants will wear a clonidine patch.
982429|NCT00858832|B3|Baseline|Total|Total of all reporting groups
982430|NCT00858832|B2|Baseline|No Methergine|
982431|NCT00858832|B1|Baseline|Methergine|
982432|NCT00858832|P2|Participant Flow|No Treatment|Participants received no intervention (no treatment).
982433|NCT00858832|P1|Participant Flow|Methergine|Participants received Methergine 0.2mg orally every 6 hours for 2 days
982434|NCT00858832|O2|Outcome|No Methergine|
982435|NCT00858832|O1|Outcome|Methergine|
982436|NCT00858832|E2|Reported Event|No Methergine|
982437|NCT00858832|E1|Reported Event|Methergine|
982438|NCT00858780|B1|Baseline|Entire Study Population|Includes all participants who were enrolled in this study.
982439|NCT00858780|P5|Participant Flow|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
982440|NCT00858780|P4|Participant Flow|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982441|NCT00858780|P3|Participant Flow|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982442|NCT00858780|P2|Participant Flow|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982443|NCT00858780|P1|Participant Flow|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
982444|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982510|NCT00858780|E5|Reported Event|Etanercept 50 mg – Period 3|Participants, who showed treatment failure in Period 2, received etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to Week 48/early termination.
982540|NCT00858637|P2|Participant Flow|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982445|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982446|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982447|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982448|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982449|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982450|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982451|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982452|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982453|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982454|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982455|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982456|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982457|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982458|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982459|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982460|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982461|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982462|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982463|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982464|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982465|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982466|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982467|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982468|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982469|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982470|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982471|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982472|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982473|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982474|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982475|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982476|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982477|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982478|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982479|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982480|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982481|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982482|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982483|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982484|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982485|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982486|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982487|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982488|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982489|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982490|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982491|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982492|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982493|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982494|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982495|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982496|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982497|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982498|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982499|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982500|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982501|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982502|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982503|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982504|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982505|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982506|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982507|NCT00858780|O3|Outcome|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982508|NCT00858780|O2|Outcome|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982509|NCT00858780|O1|Outcome|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982511|NCT00858780|E4|Reported Event|Placebo – Period 2|Placebo matched to etanercept SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982512|NCT00858780|E3|Reported Event|Etanercept 25 mg – Period 2|Etanercept 25 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 >5.1 or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 >=1.2 or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits or disease progression as determined by investigator) were reassigned to Period 3.
982513|NCT00858780|E2|Reported Event|Etanercept 50 mg – Period 2|Etanercept 50 mg SC injection once weekly along with MTX 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or IM injection up to treatment failure or Week 48/early termination. Participants who showed treatment failure (DAS28 more than [>] 5.1, or DAS28 >3.2 but <=5.1 along with an increase from baseline in DAS28 more than or equal to [>=] 1.2, or DAS28 >3.2 along with an increase from baseline >=0.6 but <1.2 on 2 consecutive visits, or disease progression as determined by investigator) were reassigned to Period 3.
982514|NCT00858780|E1|Reported Event|Etanercept 50 mg – Period 1|Etanercept 50 milligram (mg) subcutaneous (SC) injection once weekly along with methotrexate (MTX) 7.5 mg/week to 25 mg/week as a single dose or divided doses, as oral tablet or as SC or intramuscular (IM) injection, depending on the dose a participant was receiving at time of screening, for 8 weeks. Participants who maintained disease activity score based on 28-joints count (DAS28) less than or equal to (<=) 3.2 in Period 1 were randomized in Period 2.
982515|NCT00858702|B3|Baseline|Total|Total of all reporting groups
982516|NCT00858702|B2|Baseline|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
982517|NCT00858702|B1|Baseline|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
982518|NCT00858702|P2|Participant Flow|Olmesartan Medoxomil Tablets and a Diuretic Tablet|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class)once daily for 8 weeks
982519|NCT00858702|P1|Participant Flow|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
982520|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet(of the the thiazide class) once daily for 8 weeks
982521|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
982522|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
982523|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker (of the dihydropyridine class) tablet, once daily for 8 weeks
982524|NCT00858702|O2|Outcome|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic tablet (of the thiazide class) once daily for 8 weeks
982525|NCT00858702|O1|Outcome|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet (of the dihydropyridine class), once daily for 8 weeks
982526|NCT00858702|E2|Reported Event|Olmesartan Medoxomil Tablets and a Diuretic|olmesartan medoxomil tablets and a diuretic once daily for 8 weeks
982527|NCT00858702|E1|Reported Event|Olmesartan Tablets and a Calcium Channel Blocker Tablet|olmesartan medoxomil tablets and a calcium channel blocker tablet, once daily for 8 weeks
982528|NCT00858689|B1|Baseline|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
982529|NCT00858689|P1|Participant Flow|Minocyline 50 mg or 100 mg PO BID|open label, single arm study of minocyline 50 mg or 100 mg PO BID
982530|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
982531|NCT00858689|O1|Outcome|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
982532|NCT00858689|E1|Reported Event|Minocyline 50 mg or 100 mg PO BID|open label minocyline 50 mg or 100 mg PO BID
982533|NCT00858637|B3|Baseline|Total|Total of all reporting groups
982534|NCT00858637|B2|Baseline|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
982535|NCT00858637|B1|Baseline|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
982536|NCT00858637|P6|Participant Flow|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982537|NCT00858637|P5|Participant Flow|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982538|NCT00858637|P4|Participant Flow|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|"Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated~There was a gap of 2 subject between STARTED and Overall Number of Baseline Participants.~One subject did not take any study medication and excluded from Baseline Participants.~In addition, one subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
982541|NCT00858637|P1|Participant Flow|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|"Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants.~One subject (A) was randomised to simvastatin (active) group but was dispensed MCI-196 in error at Week 12. This subject was counted as STARTED of Simvastatin (Active) group but counted as Baseline Participants of MCI-196 (active) group."
982542|NCT00858637|O2|Outcome|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mgof Simvastatin / day as titrated
982543|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
982544|NCT00858637|O4|Outcome|Simvastin (Placebo) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982545|NCT00858637|O3|Outcome|Simvastin (Active) + MCI-196 (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982546|NCT00858637|O2|Outcome|MCI-196 (Placebo) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982547|NCT00858637|O1|Outcome|MCI-196 (Active) + Simvastin (Placebo)/ Withdrawal Phase|Placebo-controlled Withdrawal Phase: dose level at the end of dose titration in the flexible dose period
982548|NCT00858637|E2|Reported Event|Simvastatin (Active) + MCI-196 (Placebo)/ Comparion Phase|Active Comparison Phase: 10 mg to 40 mg of Simvastatin / day as titrated
982549|NCT00858637|E1|Reported Event|MCI-196 (Active) + Simvastatin (Placebo)/ Comparison Phase|Active Comparison Phase: 3, 6, 9, 12g of MCI-196 / day as titrated
982550|NCT00858507|B3|Baseline|Total|Total of all reporting groups
982551|NCT00858507|B2|Baseline|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
982552|NCT00858507|B1|Baseline|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
982553|NCT00858507|P2|Participant Flow|Arm 2: Social Work Based Outreach (Usual Care)|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
982554|NCT00858507|P1|Participant Flow|Arm 1: RN-based Medical Outreach, Administration of a Personal|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
982555|NCT00858507|O2|Outcome|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
982556|NCT00858507|O1|Outcome|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
982557|NCT00858507|E2|Reported Event|Arm 2: Usual Care|"Social work based outreach (usual care)~Social work administered outreach: Social worker will encounter homeless veteran in the community and encourage to come to the VA for care"
982558|NCT00858507|E1|Reported Event|Arm 1: Outreach|"RN-based medical outreach, administration of a personal health assessment and brief intervention~Personal Health Assessment/brief intervention: RN administered personal health assessment along with a brief intervention for behavior change administered to homeless veterans in the community"
982559|NCT00858494|B1|Baseline|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
982560|NCT00858494|P1|Participant Flow|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
982561|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
982562|NCT00858494|O1|Outcome|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
982563|NCT00858494|E1|Reported Event|Homeopathic Cold Remedy|Hyland's Cold 'n Cough for Kids, 5 ml by mouth up to 6 times per day as needed for cold symptoms
982564|NCT00858468|B3|Baseline|Total|Total of all reporting groups
982565|NCT00858468|B2|Baseline|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
982566|NCT00858468|B1|Baseline|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
982567|NCT00858468|P2|Participant Flow|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
982568|NCT00858468|P1|Participant Flow|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
982569|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
982570|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
982571|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
982572|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
982573|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
982574|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
982575|NCT00858468|O2|Outcome|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
982576|NCT00858468|O1|Outcome|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
982577|NCT00858468|E2|Reported Event|Age 24 to 36 Weeks|Participants enrolled at 24 to 36 weeks of age
982578|NCT00858468|E1|Reported Event|Age 6 to 12 Weeks|Participants enrolled at 6 to 12 weeks of age
982579|NCT00858442|B3|Baseline|Total|Total of all reporting groups
982580|NCT00858442|B2|Baseline|With PRP|Patients with burns sequelae on their limbs treated with release of burn contractures and skin graft with PRP between 2008-2010.
982850|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
982584|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
982585|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
982586|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
982587|NCT00858442|O1|Outcome|Without PRP|Patients did not receive plasma enriched platelets
982588|NCT00858442|O2|Outcome|With PRP|Patients received plasma enriched platelets
982589|NCT00858442|O1|Outcome|Without PRP|Patients did not received plasma enrich platelets
982590|NCT00858442|E2|Reported Event|With PRP|Patients received plasma enriched platelets
982591|NCT00858442|E1|Reported Event|Without PRP|Patients did not receive plasma enriched platelets
982592|NCT00858403|B1|Baseline|Treatment With Dasatinib|
982593|NCT00858403|P1|Participant Flow|Treatment With Dasatinib|
982594|NCT00858403|O1|Outcome|Treatment With Dasatinib|
982595|NCT00858403|O1|Outcome|Treatment With Dasatinib|
982596|NCT00858403|O1|Outcome|Treatment With Dasatinib|
982597|NCT00858403|O1|Outcome|Treatment With Dasatinib|
982598|NCT00858403|O1|Outcome|Treatment With Dasatinib|
982599|NCT00858403|O1|Outcome|Treatment With Dasatinib|
982600|NCT00858403|O1|Outcome|Treatment With Dasatinib|
982601|NCT00858403|E1|Reported Event|Treatment With Dasatinib|
982602|NCT00858390|B3|Baseline|Total|Total of all reporting groups
982603|NCT00858390|B2|Baseline|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
982604|NCT00858390|B1|Baseline|1 Standard Care|18 organ donors receiving standard care
982605|NCT00858390|P2|Participant Flow|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
982606|NCT00858390|P1|Participant Flow|1 Standard Care|18 organ donors receiving standard care
982607|NCT00858390|O2|Outcome|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
982608|NCT00858390|O1|Outcome|1 Standard Care|18 organ donors receiving standard care
982609|NCT00858390|E2|Reported Event|2 Enteral Feeding|"18 enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®~enteral feeding with Oxepa® and Glutasolve®: enteral feeding with Oxepa® and RESOURCE® GLUTASOLVE®"
982610|NCT00858390|E1|Reported Event|1 Standard Care|18 organ donors receiving standard care
982611|NCT00858247|B3|Baseline|Total|Total of all reporting groups
982612|NCT00858247|B2|Baseline|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily
982613|NCT00858247|B1|Baseline|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily
982614|NCT00858247|P2|Participant Flow|Vitamin D3-high Dose|"Vitamin D3 2000 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
982615|NCT00858247|P1|Participant Flow|Vitamin D3-low Dose|"Vitamin D3 400 IU capsule, one capsule daily~Vitamin D3: One arm would receive vitamin D3 at a dose of 400 IU by mouth once daily for 12 weeks and the other arm would receive vitamin D3 as a single oral daily dose of 2000 IU for 12 weeks."
982616|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
982617|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
982618|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
982619|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
982620|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
982621|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
982622|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
982623|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
982624|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
982625|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
982626|NCT00858247|O2|Outcome|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
982627|NCT00858247|O1|Outcome|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
982628|NCT00858247|E2|Reported Event|Vitamin D3-high Dose|Vitamin D3 2000 IU capsule, one capsule daily for 12 weeks.
982629|NCT00858247|E1|Reported Event|Vitamin D3-low Dose|Vitamin D3 400 IU capsule, one capsule daily for 12 weeks.
982630|NCT00858208|B1|Baseline|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982631|NCT00858208|P1|Participant Flow|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982632|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982633|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982634|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982677|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982635|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982636|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982637|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982638|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982639|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982640|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982641|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982642|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982643|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982644|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982645|NCT00858208|O1|Outcome|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982646|NCT00858208|E1|Reported Event|Pegaptanib|The usage and dosage recommendations for Macugen (Pegaptanib) was in accordance with the local Summary of Product Characteristics. Participants received Pegaptanib in one eye (designated study eye) while the fellow eye did not receive Pegaptanib.
982647|NCT00858143|B1|Baseline|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982648|NCT00858143|P1|Participant Flow|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982649|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982650|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982651|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982652|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982653|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982654|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982655|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982656|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982657|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982658|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982659|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982660|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982661|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982662|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982663|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982664|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982665|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982666|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982667|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982668|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982669|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982670|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982671|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982672|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982673|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982674|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982675|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982676|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982678|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982679|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982680|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982681|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982682|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982683|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982684|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982685|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982686|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982687|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982688|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982689|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982690|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982691|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982692|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982693|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982694|NCT00858143|O1|Outcome|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982695|NCT00858143|E1|Reported Event|Somavert®|Somavert® 10/15/20 milligrams (mg)(active ingredient: Pegvisomant)
982696|NCT00858013|B3|Baseline|Total|Total of all reporting groups
982697|NCT00858013|B2|Baseline|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982698|NCT00858013|B1|Baseline|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982699|NCT00858013|P2|Participant Flow|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982700|NCT00858013|P1|Participant Flow|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982701|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982702|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982703|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982704|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982705|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982706|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982707|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982708|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982709|NCT00858013|O2|Outcome|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982710|NCT00858013|O1|Outcome|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982711|NCT00858013|E2|Reported Event|Glimepiride|"Glimepiride 1~2mg once a day~Glimepiride: Glimepiride 1~2mg once a day"
982712|NCT00858013|E1|Reported Event|Nateglinide|"Nateglinide 90~120mg three times a day~Nateglinide: Nateglinide 90~120mg three times a day"
982713|NCT00857961|B1|Baseline|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
982714|NCT00857961|P1|Participant Flow|Testosterone MD-Lotion|"Applied once daily for 7 days.~All study participants received each of the 4 study treatments:~3 mL (30 mg) of 1% Testosterone metered dose (MD)-Lotion applied to both axilla (1.5 mL to each axilla).~1.5 mL (30 mg) of 2% Testosterone MD-Lotion applied to one axilla.~3 mL (60 mg) of 2% Testosterone MD-Lotion applied to both axilla (1.5 mL to each axilla).~4.5 mL (90 mg) of 2% Testosterone MD-Lotion applied by 3 doses to the axilla (2 X 1.5 mL to one axilla and 1 X 1.5 mL to the other axilla)."
982715|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982716|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982717|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982718|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982719|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982720|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982721|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982722|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982723|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982724|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982851|NCT00857649|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
982725|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982726|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982727|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982728|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982729|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982730|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982731|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982732|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982733|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982734|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982735|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982736|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982737|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982738|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982739|NCT00857961|O4|Outcome|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982740|NCT00857961|O3|Outcome|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982741|NCT00857961|O2|Outcome|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982742|NCT00857961|O1|Outcome|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982743|NCT00857961|E4|Reported Event|4.5 mL (90 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days by three doses to axilla (2 x 1.5 mL to one axilla and 1 x 1.5 mL to the other axilla).
982744|NCT00857961|E3|Reported Event|3 mL (60 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982745|NCT00857961|E2|Reported Event|1.5 mL (30 mg) of 2% Testosterone MD-Lotion|Applied once daily for 7 days to one axilla.
982746|NCT00857961|E1|Reported Event|3 mL (30 mg) of 1% Testosterone MD-Lotion|Applied once daily for 7 days to both axilla (1.5 mL to each axilla).
982747|NCT00857948|B5|Baseline|Total|Total of all reporting groups
982748|NCT00857948|B4|Baseline|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
982749|NCT00857948|B3|Baseline|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
982750|NCT00857948|B2|Baseline|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
982751|NCT00857948|B1|Baseline|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
982752|NCT00857948|P4|Participant Flow|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
982753|NCT00857948|P3|Participant Flow|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
982754|NCT00857948|P2|Participant Flow|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
982755|NCT00857948|P1|Participant Flow|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
982756|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
982757|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
982758|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
982759|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
982760|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
982761|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
982762|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
982763|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
982764|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
982765|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
982766|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
982767|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
982768|NCT00857948|O4|Outcome|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
982769|NCT00857948|O3|Outcome|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
982770|NCT00857948|O2|Outcome|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
982771|NCT00857948|O1|Outcome|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
982772|NCT00857948|E4|Reported Event|Placebo|Participants received a single treatment with placebo (treatment conditioner vehicle) on Day 1.
982773|NCT00857948|E3|Reported Event|0.50% Ivermectin|Participants received a single treatment with 0.50% ivermectin treatment conditioner on Day 1.
982774|NCT00857948|E2|Reported Event|0.25% Ivermectin|Participants received a single treatment with 0.25% ivermectin treatment conditioner on Day 1.
982775|NCT00857948|E1|Reported Event|0.15% Ivermectin|Participants received a single treatment with 0.15% ivermectin treatment conditioner on Day 1.
982776|NCT00857896|B1|Baseline|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982777|NCT00857896|P1|Participant Flow|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982778|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982779|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982780|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982781|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982782|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982783|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982784|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982785|NCT00857896|O1|Outcome|Fesoterodine|Fesoterodine 4 milligram (mg) tablet once daily (QD) from Baseline to Week 4, escalated to 8 mg tablet QD for Weeks 5 to 8.
982786|NCT00857896|E2|Reported Event|Fesoterodine 8 mg|Fesoterodine 8 mg tablet QD anytime during the study
982787|NCT00857896|E1|Reported Event|Fesoterodine 4 mg|Fesoterodine 4 mg tablet QD anytime during the study
982788|NCT00857818|B3|Baseline|Total|Total of all reporting groups
982789|NCT00857818|B2|Baseline|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982790|NCT00857818|B1|Baseline|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982791|NCT00857818|P2|Participant Flow|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982792|NCT00857818|P1|Participant Flow|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982793|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982794|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982795|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982796|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982797|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982798|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982799|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982800|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982801|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982802|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982803|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982804|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982805|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982806|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982807|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982845|NCT00857649|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
982846|NCT00857649|O2|Outcome|Placebo|Oral Tablets Once Daily
982808|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982809|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982810|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982811|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982812|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982813|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982814|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982815|NCT00857818|O2|Outcome|Control Group (Olanzapine, Risperidone, or Quetiapine)|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982816|NCT00857818|O1|Outcome|Aripiprazole|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982817|NCT00857818|E2|Reported Event|CONTROL GROUP|Participants were to continue to receive the same dose of their current antipsychotic treatment (either olanzapine, risperidone, or quetiapine) for 16 weeks.
982818|NCT00857818|E1|Reported Event|ARIPIPRAZOLE|5 mg once daily (QD) in Week 1; 10 mg QD in Week 2. Flexible dosing allowed after Week 2, adjusted in 5-mg increments every 7 days in a range of 10 to 30 mg daily.
982819|NCT00857792|B1|Baseline|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
982820|NCT00857792|P1|Participant Flow|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
982821|NCT00857792|O1|Outcome|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
982822|NCT00857792|E1|Reported Event|Open Label|regadenoson: Subjects will be given a single dose of regadenoson (0.4 mg, i.e. 5 ml i.v. bolus).
982823|NCT00857766|B3|Baseline|Total|Total of all reporting groups
982824|NCT00857766|B2|Baseline|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982825|NCT00857766|B1|Baseline|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982826|NCT00857766|P2|Participant Flow|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982827|NCT00857766|P1|Participant Flow|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982828|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982829|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982830|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982831|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982832|NCT00857766|O2|Outcome|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982833|NCT00857766|O1|Outcome|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982834|NCT00857766|E2|Reported Event|Matching Placebo|Matching placebo DISKUS twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982835|NCT00857766|E1|Reported Event|FSC DISKUS 250/50 mcg|Fluticasone Propionate/Salmeterol (FSC) DISKUS 250/50 micrograms (mcg) twice daily. At Visit 5 (Week 12), participants received open-label Tiotropium inhalation capsules 18 mcg per dose via Handihaler inhalation device.
982836|NCT00857714|B1|Baseline|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
982837|NCT00857714|P1|Participant Flow|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
982838|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
982839|NCT00857714|O1|Outcome|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
982840|NCT00857714|E1|Reported Event|1500 mg Lapatinib for 14-21 Days|Patients took 1500 mg Lapatinib for 14-21 days until surgical excision.
982841|NCT00857649|B3|Baseline|Total|Total of all reporting groups
982842|NCT00857649|B2|Baseline|Placebo|Oral Tablets Once Daily
982843|NCT00857649|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
982844|NCT00857649|P2|Participant Flow|Placebo|Oral Tablets Once Daily
982857|NCT00857649|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
982858|NCT00857623|B3|Baseline|Total|Total of all reporting groups
982859|NCT00857623|B2|Baseline|Placebo|Capsule, once daily
982860|NCT00857623|B1|Baseline|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982861|NCT00857623|P2|Participant Flow|Placebo|Capsule, once daily
982862|NCT00857623|P1|Participant Flow|AZD2066|Capsule, once daily. 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28.
982863|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982864|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982865|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982866|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982867|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982868|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982869|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982870|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982871|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982872|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982873|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982874|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982875|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982876|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982877|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982878|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982879|NCT00857623|O2|Outcome|Placebo|Capsule, once daily
982880|NCT00857623|O1|Outcome|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982881|NCT00857623|E2|Reported Event|Placebo|Capsule, once daily
982882|NCT00857623|E1|Reported Event|AZD2066|Capsule, once daily 12 mg AZD2066 day 1-4 and 18 mg AZD2066 day 5-28
982883|NCT00857584|B3|Baseline|Total|Total of all reporting groups
982884|NCT00857584|B2|Baseline|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982885|NCT00857584|B1|Baseline|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982886|NCT00857584|P2|Participant Flow|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982887|NCT00857584|P1|Participant Flow|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982888|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982889|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982890|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982891|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982892|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982893|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982894|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982895|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982896|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982897|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982898|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982899|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982900|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982901|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982902|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982903|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982904|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
983065|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
982905|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982906|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982907|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982908|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982909|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982910|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982911|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982912|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982913|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982914|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982915|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982916|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982917|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982918|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982919|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982920|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982921|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982922|NCT00857584|O2|Outcome|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982923|NCT00857584|O1|Outcome|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982924|NCT00857584|E2|Reported Event|Setraline|Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length.
982925|NCT00857584|E1|Reported Event|Quetiapine Extended Release|Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length.
982926|NCT00857532|B1|Baseline|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
982927|NCT00857532|P1|Participant Flow|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
982928|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
982929|NCT00857532|O1|Outcome|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir followed by a 10 minute PET scan 50 minutes post-injections
982930|NCT00857532|O3|Outcome|Subjects With Moderate to Severe Cognitive Impairment|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score 5 and below.
982931|NCT00857532|O2|Outcome|Subjects With Mild Cognitive Deficits|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score between 6 and 8 inclusive.
982932|NCT00857532|O1|Outcome|Subjects With Normal Cognitive Performance|Subjects have an age-and education-adjusted standardized Mattis DRS-2 score greater than or equal to 9.
982933|NCT00857532|E1|Reported Event|Subjects With Parkinson's Disease|Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.
982934|NCT00857506|B4|Baseline|Total|Total of all reporting groups
982935|NCT00857506|B3|Baseline|Cognitively Normal|
982936|NCT00857506|B2|Baseline|Mild Cognitive Impairment|
982937|NCT00857506|B1|Baseline|Alzheimer's Disease|
982938|NCT00857506|P3|Participant Flow|Cognitively Normal|Cognitively Normal (CN) subjects were recruited from study 18F-AV-45-A05 (NCT00702143). 50 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
982939|NCT00857506|P2|Participant Flow|Mild Cognitive Impairment|Subject's with Mild Cognitive Impairment (MCI) were recruited from study 18F-AV-45-A05 (NCT00702143). 36 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
982940|NCT00857506|P1|Participant Flow|Alzheimer's Disease|Subject's with Alzheimer's Disease were recruited from study 18F-AV-45-A05 (NCT00702143). None of these subjects received additional interventions in study 18F-AV-45-A11.
982941|NCT00857506|O3|Outcome|Cognitively Normal|Subjects with a baseline clinical diagnosis of CN.
982942|NCT00857506|O2|Outcome|Mild Cognitive Impairment|Subjects with a baseline clinical diagnosis of MCI.
982943|NCT00857506|O1|Outcome|Alzheimer's Disease|Subjects with a baseline clinical diagnosis of AD.
982944|NCT00857506|O6|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
1025165|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
982945|NCT00857506|O5|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
982946|NCT00857506|O4|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
982947|NCT00857506|O3|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
982948|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. All assessments were obtained for 57 subjects except for CDR-SOB and ADCS ADL which were obtained for 55 and 56 subjects respectively.
982949|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
982950|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
982951|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
982952|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline. 57 subjects were analyzed for change in ADAS-Cog and 55 subjects were analyzed for change in CDR.
982953|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
982954|NCT00857506|O4|Outcome|Amyloid-Beta Negative AD Subjects|AD subjects with a negative florbetapir F 18 PET scan at baseline.
982955|NCT00857506|O3|Outcome|Amyloid-Beta Positive AD Subjects|AD subjects with a positive florbetapir F 18 PET scan at baseline.
982956|NCT00857506|O2|Outcome|Amyloid-Beta Negative CN Subjects|CN subjects with a negative florbetapir F 18 PET scan at baseline.
982957|NCT00857506|O1|Outcome|Amyloid-Beta Positive CN Subjects|CN subjects with a positive florbetapir F 18 PET scan at baseline.
982958|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
982959|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
982960|NCT00857506|O2|Outcome|Amyloid-Beta Negative MCI Subjects|MCI subjects with a negative florbetapir F 18 PET scan at baseline.
982961|NCT00857506|O1|Outcome|Amyloid-Beta Positive MCI Subjects|MCI subjects with a positive florbetapir F 18 PET scan at baseline.
982962|NCT00857506|E3|Reported Event|Cognitively Normal|
982963|NCT00857506|E2|Reported Event|Mild Cognitive Impairment|
982964|NCT00857506|E1|Reported Event|Alzheimer's Disease|
982965|NCT00857454|B1|Baseline|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982966|NCT00857454|P1|Participant Flow|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982967|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982968|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982969|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982970|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982971|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982972|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982973|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982974|NCT00857454|O1|Outcome|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982975|NCT00857454|E1|Reported Event|Testosterone MD-lotion|30 to 120 mg of 2% Testosterone MD-Lotion administered topically once daily for 60 days
982976|NCT00857415|B3|Baseline|Total|Total of all reporting groups
982977|NCT00857415|B2|Baseline|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
982978|NCT00857415|B1|Baseline|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
982979|NCT00857415|P2|Participant Flow|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
982980|NCT00857415|P1|Participant Flow|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
982981|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
982982|NCT00857415|O1|Outcome|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques
982983|NCT00857415|O1|Outcome|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy
982984|NCT00857415|E2|Reported Event|Specificity Cohort|Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
982985|NCT00857415|E1|Reported Event|Autopsy Cohort|End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
982986|NCT00857311|B5|Baseline|Total|Total of all reporting groups
983032|NCT00857259|E2|Reported Event|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
983262|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
982987|NCT00857311|B4|Baseline|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
982988|NCT00857311|B3|Baseline|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
982989|NCT00857311|B2|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
982990|NCT00857311|B1|Baseline|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
982991|NCT00857311|P4|Participant Flow|Open Label Tetanus and Diptheria Toxoids Adsorbed|"Participants were to be administered open label tetanus and diptheria toxoids adsorbed (Td) at Day 1 only.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in this group."
982992|NCT00857311|P3|Participant Flow|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
982993|NCT00857311|P2|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^10 vp/Dose|"Participants were to be administered MRKAd5 HIV-1 gag 1x10^10 vp/dose (V520) on Day 1, Week 4, and Week 26.~Per a letter dated 30-Aug-2005 all sites were notified that due to recruitment challenges enrollment would be halted as of 01-Oct-2005. Consequently, no participants were enrolled in the group MRKAd5 HIV-1 gag 1x10^10 vp/dose."
982994|NCT00857311|P1|Participant Flow|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
982995|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
982996|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
982997|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
982998|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
982999|NCT00857311|O2|Outcome|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
983000|NCT00857311|O1|Outcome|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
983001|NCT00857311|E2|Reported Event|Placebo|Participants administered placebo to MRKAd5 HIV-1 gag vaccine (V520) on Day 1, Week 4, and Week 26.
983002|NCT00857311|E1|Reported Event|MRKAd5 HIV-1 Gag Vaccine 1x10^9 vp/Dose|Participants administered MRKAd5 HIV-1 gag vaccine 1x10^9 viral particles (vp)/dose (V520), on Day 1, Week 4, and Week 26.
983003|NCT00857285|B3|Baseline|Total|Total of all reporting groups
983004|NCT00857285|B2|Baseline|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
983005|NCT00857285|B1|Baseline|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
983006|NCT00857285|P2|Participant Flow|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
983007|NCT00857285|P1|Participant Flow|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
983008|NCT00857285|O2|Outcome|Losartan Potassium|losartan potassium oral tablets, once daily for up to 12 weeks
983009|NCT00857285|O1|Outcome|Olmesartan Medoxomil|olmesartan medoxomil oral tablets, once daily for up to 12 weeks
983010|NCT00857272|B3|Baseline|Total|Total of all reporting groups
983011|NCT00857272|B2|Baseline|HalfLytely With 10mg Bisacodyl|Active Control
983012|NCT00857272|B1|Baseline|HalfLytely With 5mg Bisacodyl|Investigational dose
983013|NCT00857272|P2|Participant Flow|HalfLytely With 10mg Bisacodyl|Active Control
983014|NCT00857272|P1|Participant Flow|HalfLytely With 5mg Bisacodyl|Investigational dose
983015|NCT00857272|O2|Outcome|HalfLytely With 10mg Bisacodyl|Active Control
983016|NCT00857272|O1|Outcome|HalfLytely With 5mg Bisacodyl|Investigational dose
983017|NCT00857272|E2|Reported Event|HalfLytely With 10mg Bisacodyl|Active Control
983018|NCT00857272|E1|Reported Event|HalfLytely With 5mg Bisacodyl|Investigational dose
983019|NCT00857259|B4|Baseline|Total|Total of all reporting groups
983020|NCT00857259|B3|Baseline|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
983021|NCT00857259|B2|Baseline|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
983022|NCT00857259|B1|Baseline|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
983023|NCT00857259|P3|Participant Flow|Everolimus and Ranibizumab|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
983024|NCT00857259|P2|Participant Flow|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (baseline)
983025|NCT00857259|P1|Participant Flow|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
983026|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus oral 5 mg once daily plus ranibizumab Intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
983027|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on Day 1 (Baseline)
983028|NCT00857259|O1|Outcome|Everolimus 5 mg|5 mg orally once daily plus sham ocular injection on Day 1 (Baseline)
983029|NCT00857259|O3|Outcome|Everolimus 5 mg and Ranibizumab 0.5 mg|Everolimus orally 5 mg once daily plus Ranibizumab intra-vitreal therapy (IVT) 0.5 mg on day 1 (baseline)
983030|NCT00857259|O2|Outcome|Ranibizumab 0.5 mg|Ranibizumab intra-vitreal therapy 0.5 mg on Day 1 (baseline)
983031|NCT00857259|O1|Outcome|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
983033|NCT00857259|E1|Reported Event|Oral Everolimus 5 mg|5 mg once daily plus sham ocular injection on Day 1 (Baseline)
983067|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983068|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983034|NCT00857246|B1|Baseline|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983035|NCT00857246|P1|Participant Flow|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983036|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983037|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983038|NCT00857246|O1|Outcome|Induction Treatment|Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.
983039|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (3-4 weeks after induction treatment).~Chemoradiation treatment (4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983040|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983041|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment ( starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983042|NCT00857246|O1|Outcome|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983043|NCT00857246|E1|Reported Event|Induction/ Surgery/ chemoRT|"Induction treatment (3 weeks/cycle x 4 cycles): Cisplatin and Irinotecan on days 1 and 8; Cetuximab on days 1, 8, and 15.~Surgery (starts 3-4 weeks after induction treatment).~Chemoradiation treatment (starts 4-6 weeks after surgery):~weeks 1-19: Cetuximab on day 1 of every week; week 1: 5-FU and Leucovorin (LV) x 5 days; weeks 2-4: recovery; weeks 5-9: radiation, 150 cGy x 5 fractions/week x 5 weeks; week 5: 5-FU+ LV on days 1-4; week 9: 5-FU+ LV on days 1-3; weeks 14 and 19: 5-FU+LV x 5days"
983044|NCT00857233|B1|Baseline|Memantine|20 mg Oral Tablets Once Daily
983045|NCT00857233|P1|Participant Flow|Memantine|20 mg Oral Tablets Once Daily
983046|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
983047|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
983048|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
983049|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
983050|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
983051|NCT00857233|O1|Outcome|Memantine|20 mg Oral Tablets Once Daily
983052|NCT00857233|E1|Reported Event|Memantine|20 mg Oral Tablets Once Daily
983053|NCT00857220|B1|Baseline|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983054|NCT00857220|P1|Participant Flow|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983055|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983056|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983057|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983058|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983059|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983060|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983061|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983062|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983063|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983064|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983066|NCT00857220|O1|Outcome|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983069|NCT00857220|E1|Reported Event|2mg Eszopiclone (6-11yrs), 3mg Eszopiclone (12-17yrs)|Eszopiclone Overall
983070|NCT00856986|B6|Baseline|Total|Total of all reporting groups
983071|NCT00856986|B5|Baseline|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983072|NCT00856986|B4|Baseline|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983073|NCT00856986|B3|Baseline|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983074|NCT00856986|B2|Baseline|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983075|NCT00856986|B1|Baseline|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983076|NCT00856986|P5|Participant Flow|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983077|NCT00856986|P4|Participant Flow|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983078|NCT00856986|P3|Participant Flow|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983079|NCT00856986|P2|Participant Flow|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983080|NCT00856986|P1|Participant Flow|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983081|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983082|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983083|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983084|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983263|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
987906|NCT00847197|B3|Baseline|Total|Total of all reporting groups
983284|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983285|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983286|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983085|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983086|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983087|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983088|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983089|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983090|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983091|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983092|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983093|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983094|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983095|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983096|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983097|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983098|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983099|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983264|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983265|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
988613|NCT00844857|B3|Baseline|Total|Total of all reporting groups
983100|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983101|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983102|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983103|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983104|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983105|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983106|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983107|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983108|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983109|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983110|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983111|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983112|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983113|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983114|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983266|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983267|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983115|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983116|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983117|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983118|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983119|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983120|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983121|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983122|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983123|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983124|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983125|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983126|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983127|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983128|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983129|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983268|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983269|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
989511|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
983130|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983131|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983132|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983133|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983134|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983135|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983136|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983137|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983138|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983139|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983140|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983141|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983142|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983143|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983144|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983270|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983271|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
989512|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
983145|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983146|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983147|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983148|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983149|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983150|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983151|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983152|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983153|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983154|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983155|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983156|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983157|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983158|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983159|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983272|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983273|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983160|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983161|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983162|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983163|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983164|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983165|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983166|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983167|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983168|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983169|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983170|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983171|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983172|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983173|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983174|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983274|NCT00856973|O3|Outcome|Placebo|Placebo once daily
983275|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily
989513|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
983175|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983176|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983177|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983178|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983179|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983180|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983181|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983182|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983183|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983184|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983185|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983186|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983187|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983188|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983189|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983276|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily
983277|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983190|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983191|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983192|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983193|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983194|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983195|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983196|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983197|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983198|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983199|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983200|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983201|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983202|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983203|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983204|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983278|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983279|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983205|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983206|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983207|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983208|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983209|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983210|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983211|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983212|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983213|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983214|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983215|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983216|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983217|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983218|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983219|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983280|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983281|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
990640|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
983220|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983221|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983222|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983223|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983224|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983225|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983226|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983227|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983228|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983229|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983230|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983231|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983232|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983233|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983234|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983282|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983283|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
990641|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
983235|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983236|NCT00856986|O5|Outcome|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983237|NCT00856986|O4|Outcome|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983238|NCT00856986|O3|Outcome|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983239|NCT00856986|O2|Outcome|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983240|NCT00856986|O1|Outcome|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983241|NCT00856986|E5|Reported Event|Intensified Group|Intensification of treatment with insulin detemir was offered at Weeks 26 and 38 for subjects with an HbA1c ≥ 8.0% in the randomised Lira 1.8 group and non-randomised liraglutide treatment group.
983242|NCT00856986|E4|Reported Event|Early Withdrawals Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Due to withdrawals in the run-in period, subjects did not receive any further treatment in trial
983243|NCT00856986|E3|Reported Event|Non-Randomised Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects continued to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was below 7.0%
983244|NCT00856986|E2|Reported Event|Insulin Detemir + Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin in addition to individually adjusted insulin detemir for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983245|NCT00856986|E1|Reported Event|Lira 1.8|Subcutaneous administration of liraglutide 1.8 mg once daily in a forced 12 week run-in period + subject’s own pre-trial metformin treatment at an unchanged dose and frequency (at least 1500 mg daily). Initial dose of liraglutide 0.6 mg/day with weekly increments of 0.6 mg until final dose of 1.8 mg/day was reached. Subjects were randomised to continue to receive liraglutide 1.8 mg once daily + metformin for 26 weeks plus 26 weeks extension, when the HbA1c assessment after run-in period was at least 7.0%
983246|NCT00856973|B4|Baseline|Total|Total of all reporting groups
983247|NCT00856973|B3|Baseline|Placebo|Placebo Once Daily. This included only patients that were randomized (ITT population).
983248|NCT00856973|B2|Baseline|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg eszopiclone for 12-17 years once daily. This includes only patients that were randomized (ITT population).
983249|NCT00856973|B1|Baseline|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years once daily. This included only patients that were randomized (ITT population).
983250|NCT00856973|P3|Participant Flow|Placebo|Placebo 6-17 years
983251|NCT00856973|P2|Participant Flow|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983252|NCT00856973|P1|Participant Flow|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983253|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983254|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983255|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983256|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983257|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983258|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983259|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983260|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983261|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983287|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983288|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983289|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983290|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983291|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983292|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983293|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983294|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983295|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983296|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983297|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983298|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983299|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983300|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983301|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983302|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983303|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983304|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983305|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983306|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983307|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years once daily
983308|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983309|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983310|NCT00856973|O3|Outcome|Placebo|Placebo 6-17 years
983311|NCT00856973|O2|Outcome|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983312|NCT00856973|O1|Outcome|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983313|NCT00856973|E3|Reported Event|Placebo|Placebo 6-17 years once daily
983314|NCT00856973|E2|Reported Event|Pooled Low Dose Eszopiclone|1 mg eszopiclone for 6-11 years, 2 mg for 12-17 years
983315|NCT00856973|E1|Reported Event|Pooled High Dose Eszopiclone|2 mg eszopiclone for 6-11 years, 3 mg eszopiclone for 12-17 years
983316|NCT00856934|B4|Baseline|Total|Total of all reporting groups
983317|NCT00856934|B3|Baseline|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983318|NCT00856934|B2|Baseline|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983319|NCT00856934|B1|Baseline|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
983320|NCT00856934|P3|Participant Flow|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983321|NCT00856934|P2|Participant Flow|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983322|NCT00856934|P1|Participant Flow|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
983323|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983324|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983325|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
983326|NCT00856934|O3|Outcome|PRP+K|Keratinocytes suspended in Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983327|NCT00856934|O2|Outcome|PRP|Platelet Rich Plasma (PRP) sprayed onto the wound bed with Calcium Chloride. Wounds covered with same standard dressings used in control group.
983328|NCT00856934|O1|Outcome|Control|Wounds covered with standard dressings: three layers of paraffin gauze, standard bandages, elastic bandage.
983329|NCT00856908|B3|Baseline|Total|Total of all reporting groups
983330|NCT00856908|B2|Baseline|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983331|NCT00856908|B1|Baseline|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983332|NCT00856908|P2|Participant Flow|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983333|NCT00856908|P1|Participant Flow|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983457|NCT00856583|P1|Participant Flow|Sertindole|Normally in the range of 4 to 20 mg/day
983334|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983458|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983335|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983336|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983337|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983338|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983339|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983340|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983341|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983342|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983343|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983344|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983345|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983346|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983347|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983348|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983349|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983350|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983351|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983352|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983353|NCT00856908|O2|Outcome|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983354|NCT00856908|O1|Outcome|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983355|NCT00856908|E2|Reported Event|Placebo Comparator|placebo Dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983356|NCT00856908|E1|Reported Event|Experimental|AZD1656 dose titration of oral suspension during 4 days to a tolerable dose given twice daily. Subjects will thereafter be treated with this dose twice daily for another 24 days
983357|NCT00856843|B3|Baseline|Total|Total of all reporting groups
983358|NCT00856843|B2|Baseline|BLI800|Investigational prep - oral solution, 1 administration
983359|NCT00856843|B1|Baseline|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983360|NCT00856843|P2|Participant Flow|BLI800|Investigational prep - oral solution, 1 administration
983361|NCT00856843|P1|Participant Flow|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983362|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983363|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983364|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983365|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983366|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983367|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983368|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983369|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983370|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983371|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983372|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983373|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983374|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983375|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983376|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983377|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983378|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983379|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983380|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983381|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983382|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983383|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983384|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983385|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983386|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983387|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983388|NCT00856843|O2|Outcome|BLI800|Investigational prep - oral solution, 1 administration
983389|NCT00856843|O1|Outcome|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983390|NCT00856843|E2|Reported Event|BLI800|Investigational prep - oral solution, 1 administration
983391|NCT00856843|E1|Reported Event|Polyethylene Glycol 3350 Based Bowel Preparation|Active control - oral solution, 1 administration
983392|NCT00856791|B1|Baseline|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
983393|NCT00856791|P1|Participant Flow|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
983394|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
983395|NCT00856791|O1|Outcome|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
983396|NCT00856791|E1|Reported Event|ON 01910.Na|3200 mg ON 01910.Na administered intravenously over 2 hours on days 1, 4, 8, 11, 15, and 18 of 28-day cycle
983397|NCT00856778|B1|Baseline|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
983398|NCT00856778|P1|Participant Flow|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983399|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983400|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983401|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983402|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983403|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983404|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983405|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983406|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983407|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983408|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983459|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983460|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983461|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983409|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983410|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983411|NCT00856778|O1|Outcome|Subjects Implanted With Virtue® Male Sling|The Coloplast Virtue® Male Sling System is a permanent, synthetic suburethral sling, designed for the surgical treatment of male stress urinary incontinence (SUI). The Virtue® sling is made from knitted, monofilament polypropylene, and is for single-use only.
983412|NCT00856778|E1|Reported Event|Subjects Implanted With Virtue® Male Sling|The Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from intrinsic sphincter deficiency. The sling is manufactured from polypropylene and is sold for single use only.
983413|NCT00856739|B4|Baseline|Total|Total of all reporting groups
983414|NCT00856739|B3|Baseline|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
983415|NCT00856739|B2|Baseline|Overweight|Body mass index between 25 and 30 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
983416|NCT00856739|B1|Baseline|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
983417|NCT00856739|P3|Participant Flow|Obese|Body mass index over 30 kg/m^2
983418|NCT00856739|P2|Participant Flow|Overweight|Body mass index between 25 and 30 kg/m^2
983419|NCT00856739|P1|Participant Flow|Normal Weight|Body mass index between 18 and 25 kg/m^2
983420|NCT00856739|O4|Outcome|Overweight and Obese Middle Age|Body mass index between 27 and 50 kg/m^2, age between 35 and 60
983421|NCT00856739|O3|Outcome|Normal Weight Middle Age|Body mass index between 18 and 25 kg/m^2, age between 35 and 60
983422|NCT00856739|O2|Outcome|Overweight and Obese Young|Body mass index between 27 and 50 kg/m^2, age between 20 and 35
983423|NCT00856739|O1|Outcome|Normal Weight Young|Body mass index between 18 and 25 kg/m^2, age between 20 and 35
983424|NCT00856739|O2|Outcome|Obese|Body mass index between 30 and 50 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
983425|NCT00856739|O1|Outcome|Normal Weight|Body mass index between 18 and 25 kg/m^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
983426|NCT00856739|E3|Reported Event|Obese|Body mass index between 30 and 50 kg/m^2
983427|NCT00856739|E2|Reported Event|Overweight|Body mass index between 25 and 30 kg/m^2
983428|NCT00856739|E1|Reported Event|Normal Weight|Body mass index between 18 and 25 kg/m^2
983429|NCT00856661|B3|Baseline|Total|Total of all reporting groups
983430|NCT00856661|B2|Baseline|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983431|NCT00856661|B1|Baseline|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983432|NCT00856661|P2|Participant Flow|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983433|NCT00856661|P1|Participant Flow|Desmoteplase|90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983434|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983435|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983436|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983437|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983438|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983439|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983440|NCT00856661|O2|Outcome|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983441|NCT00856661|O1|Outcome|Desmoteplase|Desmoteplase: 90 μg/kg bodyweight, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983442|NCT00856661|E2|Reported Event|Desmoteplase|Desmoteplase: 90 ug/kg, IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983443|NCT00856661|E1|Reported Event|Placebo|Placebo: IV, single bolus over 1 to 2 minutes 3-9 hours after symptoms onset
983444|NCT00856635|B3|Baseline|Total|Total of all reporting groups
983445|NCT00856635|B2|Baseline|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
983446|NCT00856635|B1|Baseline|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
983447|NCT00856635|P2|Participant Flow|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
983448|NCT00856635|P1|Participant Flow|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
983449|NCT00856635|O2|Outcome|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
983450|NCT00856635|O1|Outcome|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
983451|NCT00856635|E2|Reported Event|Placebo|Participants received placebo subcutaneous injection once a day for up to 6 months.
983452|NCT00856635|E1|Reported Event|Glatiramer Acetate|Participants received glatiramer acetate 20 mg subcutaneous injection once a day for up to 6 months.
983453|NCT00856583|B3|Baseline|Total|Total of all reporting groups
983454|NCT00856583|B2|Baseline|Risperidone|Normally in the range of 2 to 8 mg/day
983455|NCT00856583|B1|Baseline|Sertindole|Normally in the range of 4 to 20 mg/day
983456|NCT00856583|P2|Participant Flow|Risperidone|Normally in the range of 2 to 8 mg/day
983462|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983463|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983464|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983465|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983466|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983467|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983468|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983469|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983470|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983471|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983472|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983473|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983474|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983475|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983476|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983477|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983478|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983479|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983480|NCT00856583|O2|Outcome|Risperidone|Normally in the range of 2 to 8 mg/day
983481|NCT00856583|O1|Outcome|Sertindole|Normally in the range of 4 to 20 mg/day
983482|NCT00856583|E2|Reported Event|Risperidone|Normally in the range of 2 to 8 mg/day
983483|NCT00856583|E1|Reported Event|Sertindole|Normally in the range of 4 to 20 mg/day
983484|NCT00856557|B3|Baseline|Total|Total of all reporting groups
983485|NCT00856557|B2|Baseline|No Intervention|No educational intervention
983486|NCT00856557|B1|Baseline|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
983487|NCT00856557|P2|Participant Flow|No Intervention|No educational intervention
983488|NCT00856557|P1|Participant Flow|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
983489|NCT00856557|O2|Outcome|No Intervention|No educational intervention
983490|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
983491|NCT00856557|O2|Outcome|No Intervention|No educational intervention
983492|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
983493|NCT00856557|O2|Outcome|No Intervention|No educational intervention
983494|NCT00856557|O1|Outcome|Seminar and Practicum|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
983495|NCT00856557|E2|Reported Event|No Intervention|No educational intervention
983496|NCT00856557|E1|Reported Event|Seminar and Practium|"Seminar and practicum that occurs over 4 week period for internal medicine residents, designed to provide a systematic approach to identifying and addressing contextual factors essential to planning patient care.~Seminar and Practicum on Contextualizing Care: A 4 hour seminar and practicum for internal medicine residents designed to provide a systematic approach to identifying contextual factors essential to planning patient care."
983497|NCT00856544|B5|Baseline|Total|Total of all reporting groups
983498|NCT00856544|B4|Baseline|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983499|NCT00856544|B3|Baseline|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983500|NCT00856544|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983501|NCT00856544|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
990642|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
983557|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983613|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
984060|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
983502|NCT00856544|P4|Participant Flow|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983503|NCT00856544|P3|Participant Flow|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983504|NCT00856544|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983505|NCT00856544|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983506|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983507|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983508|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983509|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983510|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983511|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983512|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983513|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983514|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983515|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983516|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983517|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983518|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983519|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983520|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983521|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983522|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983523|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983524|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983525|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983526|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983527|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983556|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
990643|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
983528|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983529|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983530|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983531|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983532|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983533|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983534|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983535|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983536|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983537|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983538|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983539|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983540|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983541|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983542|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983543|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983544|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983545|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983546|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983547|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983548|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983549|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983550|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983551|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983552|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983553|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983554|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983555|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983558|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983559|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983560|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983561|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983562|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983563|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983564|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983565|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983566|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983567|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983568|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983569|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983570|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983571|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983572|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983573|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983574|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983575|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983576|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983577|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983578|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983579|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983580|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983581|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983582|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983583|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983584|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983585|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983586|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983587|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983588|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983589|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983590|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983591|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983592|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983593|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983594|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983595|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983596|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983597|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983598|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983599|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983600|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983601|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983602|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983603|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983604|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983605|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983606|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983607|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983608|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983609|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983610|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983611|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
990644|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
983612|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983614|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983615|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983616|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983617|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983618|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983619|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983620|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983621|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983622|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983623|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983624|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983625|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983626|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983627|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983628|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983629|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983630|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983631|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983632|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983633|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983634|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983635|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983636|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983637|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983638|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983667|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983668|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
984058|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
983669|NCT00856544|E12|Reported Event|Placebo, Then CP-690,550 10 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 10 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 10 mg tablet twice daily from Month 6 to 12.
983639|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983640|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983641|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983642|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983643|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983644|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983645|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983646|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983647|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983648|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983649|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983650|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983651|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983652|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983653|NCT00856544|O4|Outcome|Placebo Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 12.
983654|NCT00856544|O3|Outcome|Placebo Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 12.
983655|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983656|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983657|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983658|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983659|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983660|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983661|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983662|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983663|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983664|NCT00856544|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 12.
983665|NCT00856544|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 12.
983666|NCT00856544|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 12.
983670|NCT00856544|E11|Reported Event|Placebo, Then CP-690,550 5 mg (Post Month 6)|Participants who received matching placebo twice daily up to Month 3 and matching placebo or CP-690,550 5 mg tablet orally twice daily from Month 3 to 6, received CP-690,550 5 mg tablet twice daily from Month 6 to 12.
983671|NCT00856544|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily from Month 6 to 12.
983672|NCT00856544|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
983673|NCT00856544|E8|Reported Event|Placebo, Then CP-690,550 10 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 10 mg tablet twice daily from Month 3 to 6.
983674|NCT00856544|E7|Reported Event|Placebo, Then CP-690,550 5 mg (Month 3 to 6)|Participants who received matching placebo twice daily up to Month 3, received CP-690,550 5 mg tablet twice daily from Month 3 to 6.
983675|NCT00856544|E6|Reported Event|Placebo (Month 3 to 6)|Matching placebo twice daily from Month 3 to 6.
983676|NCT00856544|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet twice daily from Month 3 to 6.
983677|NCT00856544|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg twice daily from Month 3 to 6.
983678|NCT00856544|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo Film-coated tablet orally twice daily up to Month 3.
983679|NCT00856544|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg Film-coated tablet administered orally twice daily up to Month 3.
983680|NCT00856544|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg Film-coated tablet administered orally twice daily up to Month 3.
983681|NCT00856518|B3|Baseline|Total|Total of all reporting groups
983682|NCT00856518|B2|Baseline|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
983683|NCT00856518|B1|Baseline|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
983684|NCT00856518|P2|Participant Flow|Arm 2: Sham Group|"sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
983685|NCT00856518|P1|Participant Flow|Arm 1: EMST|"Experimental Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
983686|NCT00856518|O2|Outcome|Arm 2: Sham Group|"The sham group undergoes the same 5-week EMST exercise as the experimental group using the same device but without a spring for minimal pressure load~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
983687|NCT00856518|O1|Outcome|Arm 1: EMST|"The experimental group receives five weeks of expiratory muscle strength training (EMST) using a positive pressure threshold device~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
983688|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
983689|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
983690|NCT00856518|O2|Outcome|Arm 2: Sham|"Sham group~sham device: Looks just like the EMST device but does not provide a load on the target muscle group"
983691|NCT00856518|O1|Outcome|Arm 1: EMST|"EMST Group~Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles."
983692|NCT00856518|E2|Reported Event|Arm 2: Sham Group|Sham Device: Looks just like the EMST device but does not provide a load on the target muscle group
983693|NCT00856518|E1|Reported Event|Arm 1: EMST|Expiratory Muscle Strength Trainer: Pressure threshold device targeted at increase muscle force generation of expiratory and submental muscles.
983694|NCT00856414|B1|Baseline|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983695|NCT00856414|P1|Participant Flow|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983696|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983697|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983698|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983699|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983700|NCT00856414|O1|Outcome|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983701|NCT00856414|E1|Reported Event|Botulinum Toxin Type A 20U|botulinum toxin Type A 20U
983702|NCT00856388|B1|Baseline|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983703|NCT00856388|P1|Participant Flow|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983704|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
983725|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
983705|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983706|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983707|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983708|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983709|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983710|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983711|NCT00856388|O1|Outcome|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan."
983712|NCT00856388|E1|Reported Event|Treatment (Reduced Intensity Allogeneic Stem Cell Transplant)|"Patients receive fludarabine phosphate IV over 30 minutes on days -5 to -2 and melphalan* IV over 30 minutes on day -2. Patients then undergo total-body irradiation on day -1 and allogeneic stem cell transplantation on day 0.~Note: *Patients with chromosomal breakage syndromes, such as Fanconi anemia or dyskeratosis congenita, receive anti-thymocyte globulin IV over 4 hours on day -4 to -2 instead of melphalan.~fludarabine phosphate: Given IV~melphalan: Given IV~total-body irradiation: Undergo total-body irradiation~allogeneic hematopoietic stem cell transplantation: Undergo allogeneic stem cell transplantation~anti-thymocyte globulin: Given IV"
983713|NCT00856349|B1|Baseline|Analysis Cohort|"Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.~Therapy Programming Report (TPR): Center-specific therapy programming reports (TPRs) illustrating physician usage of shock reduction programming are provided to each center approximately 9-12 months after their first enrollment and monthly thereafter throughout the study."
983714|NCT00856349|P1|Participant Flow|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward the primary and/or secondary study endpoints.
983715|NCT00856349|O1|Outcome|Subjects With Final Programming Data Available|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints, with final programming data available post-TPR distribution.
983716|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
983717|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
983718|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
983719|NCT00856349|O1|Outcome|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
983720|NCT00856349|O1|Outcome|Subjects With Paired Programming Data|Subjects with paired baseline and follow-up programming data to evaluate changes in shock-reduction programming parameters
983721|NCT00856349|E1|Reported Event|Analysis Cohort|Enrolled subjects who met study eligibility criteria and contributed data toward study endpoints.
983722|NCT00856323|B1|Baseline|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
983723|NCT00856323|P1|Participant Flow|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
983724|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
983815|NCT00856232|O2|Outcome|Medical Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
983816|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
983726|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
983727|NCT00856323|O1|Outcome|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
983728|NCT00856323|E1|Reported Event|PEP/CM|"Truvada : At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).~CM : Participants will submit a urine sample every Monday, Wednesday, and Friday for 8 weeks (a total of 24 urine samples). Samples will be tested for methamphetamine metabolites."
983729|NCT00856297|B6|Baseline|Total|Total of all reporting groups
983730|NCT00856297|B5|Baseline|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983731|NCT00856297|B4|Baseline|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
983732|NCT00856297|B3|Baseline|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
983733|NCT00856297|B2|Baseline|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
983734|NCT00856297|B1|Baseline|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983735|NCT00856297|P5|Participant Flow|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983736|NCT00856297|P4|Participant Flow|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983737|NCT00856297|P3|Participant Flow|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
983738|NCT00856297|P2|Participant Flow|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
983739|NCT00856297|P1|Participant Flow|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983740|NCT00856297|O3|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
983741|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
983742|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983743|NCT00856297|O4|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983744|NCT00856297|O3|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983745|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination..
983746|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983747|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983748|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983749|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983750|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983751|NCT00856297|O2|Outcome|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983752|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983817|NCT00856232|E3|Reported Event|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
983753|NCT00856297|O2|Outcome|Licensed Comparator/MenACWY-CRM|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study, and one booster dose of MenACWY- CRM conjugate vaccine in the present study at 3 years after primary vaccination.
983754|NCT00856297|O1|Outcome|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983755|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
983756|NCT00856297|O1|Outcome|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
983757|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
983758|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983759|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
983760|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983761|NCT00856297|O2|Outcome|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
983762|NCT00856297|O1|Outcome|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983763|NCT00856297|E5|Reported Event|Licensed Comparator /MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
983764|NCT00856297|E4|Reported Event|MenACWY-CRM/MenACWY-CRM|Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine in the present study at 3 years after primary vaccination.
983765|NCT00856297|E3|Reported Event|Naive|Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
983766|NCT00856297|E2|Reported Event|Licensed Comparator|Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
983767|NCT00856297|E1|Reported Event|MenACWY-CRM|Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
983768|NCT00856284|B4|Baseline|Total|Total of all reporting groups
983769|NCT00856284|B3|Baseline|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983770|NCT00856284|B2|Baseline|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983771|NCT00856284|B1|Baseline|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983772|NCT00856284|P3|Participant Flow|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983773|NCT00856284|P2|Participant Flow|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983774|NCT00856284|P1|Participant Flow|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983775|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983776|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983777|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983778|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983779|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983780|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983818|NCT00856232|E2|Reported Event|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
983819|NCT00856232|E1|Reported Event|Standard Therapy|Standard emergency department evaluation and treatment for headache
983821|NCT00856206|B2|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
984061|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
983781|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983782|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983783|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983784|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983785|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983786|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983787|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983788|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983789|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983790|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983791|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983792|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983793|NCT00856284|O3|Outcome|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983794|NCT00856284|O2|Outcome|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983795|NCT00856284|O1|Outcome|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983796|NCT00856284|E3|Reported Event|Metformin + Glipizide|Glipizide 5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks. After at least 2 weeks of treatment but prior to Week 20, participants with persistent hyperglycemia (fasting plasma glucose ≥250 mg/dL) underwent a dose titration of glipizide up to 20 mg in 5-mg increments in 4-week intervals.
983797|NCT00856284|E2|Reported Event|Metformin + Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983798|NCT00856284|E1|Reported Event|Metformin + Alogliptin 12.5 mg|Alogliptin 12.5 mg, tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
983799|NCT00856245|B1|Baseline|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
983800|NCT00856245|P1|Participant Flow|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
983801|NCT00856245|O1|Outcome|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
983802|NCT00856245|O1|Outcome|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
983803|NCT00856245|E1|Reported Event|Rituximab|Rituximab: 375 MG/M2 given IV weekly x 4-8 doses.
983804|NCT00856232|B4|Baseline|Total|Total of all reporting groups
983805|NCT00856232|B3|Baseline|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
983806|NCT00856232|B2|Baseline|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
983807|NCT00856232|B1|Baseline|Standard Therapy|Standard emergency department evaluation and treatment for headache
983808|NCT00856232|P3|Participant Flow|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
983809|NCT00856232|P2|Participant Flow|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
983810|NCT00856232|P1|Participant Flow|Standard Therapy|Standard emergency department evaluation and treatment for headache
983811|NCT00856232|O3|Outcome|Oxygen|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
983812|NCT00856232|O2|Outcome|Air at 15L/Min|Air inhalation at 15L / min x 15 minutes followed by standard emergency department evaluation and treatment for headache
983813|NCT00856232|O1|Outcome|Standard Therapy|Standard emergency department evaluation and treatment for headache
983814|NCT00856232|O3|Outcome|Oxygen at 15 L / Min|Oxygen inhalation at 15 L/min for 15 minutes followed by standard emergency department evaluation and treatment for headache
983820|NCT00856206|B3|Baseline|Total|Total of all reporting groups
983822|NCT00856206|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
983823|NCT00856206|P2|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
983824|NCT00856206|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
983825|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
983826|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
983827|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
983828|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
983829|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
983830|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
983831|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
983832|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
983833|NCT00856206|O2|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
983834|NCT00856206|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
983835|NCT00856206|E2|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
983836|NCT00856206|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
983837|NCT00856193|B1|Baseline|All Randomized Patients|NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Matching placebo 50 µg capsules for inhalation once daily with Concept 1 device.
983838|NCT00856193|P2|Participant Flow|Placebo Then NVA237 50μg|Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device.
983839|NCT00856193|P1|Participant Flow|NVA237 50μg Then Placebo|NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device.
983840|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983841|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983842|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983843|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983844|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983845|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983846|NCT00856193|O2|Outcome|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983847|NCT00856193|O1|Outcome|NVA237 50μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983848|NCT00856193|E2|Reported Event|NVA237 50 μg|NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983849|NCT00856193|E1|Reported Event|Placebo|Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device.
983850|NCT00856180|B1|Baseline|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
983851|NCT00856180|P1|Participant Flow|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
983852|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
983966|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983853|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
983854|NCT00856180|O2|Outcome|Platinum Resistant|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum resisistant is defined as having had a </=6 month interval since last receiving platinum therapy prior to disease recurrence.
983855|NCT00856180|O1|Outcome|Platinum Sensitive|At baseline, participants were classified as platinum sensitive or platinum resistant. Platinum sensitive is defined as having had a >6 month interval since last receiving platinum therapy prior to disease recurrence.
983856|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
983857|NCT00856180|O1|Outcome|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
983858|NCT00856180|E1|Reported Event|Bevacizumab Then Cyclophosphamide With Bevacizumab|Patients were given a regimen of sequential antiangiogenic blockade and disease assessed serologically and radiologically every 6 weeks. Patients started with bevacizumab 15 mg/kg IV every 3 weeks until they experienced progressive disease (PD) [RECIST 1.0 or Rustin criteria] or significant toxicity. If clinically stable as assessed by their treating physician, patients then received cyclophosphamide 50 mg orally (PO) daily continuously with bevacizumab treatment. If second PD occurred, patients discontinued the combination treatment.
983859|NCT00856050|B1|Baseline|Letrozole|letrozole 2.5mg by mouth per day
983860|NCT00856050|P1|Participant Flow|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
983861|NCT00856050|O1|Outcome|Letrozole|letrozole 2.5mg by mouth per day
983862|NCT00856050|E1|Reported Event|Letrozole|Experimental: letrozole single arm trial - all patients received letrozole 2.5mg by mouth per day
983863|NCT00856024|B1|Baseline|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983864|NCT00856024|P1|Participant Flow|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983865|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983866|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983867|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983868|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983869|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983870|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983871|NCT00856024|O3|Outcome|HIV/Hepatitis C Virus (HCV) Co-infected Participants|Participants, from Brazil, with confirmed chronic hepatitis C and infected with human immunodeficiency virus (HIV) who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983872|NCT00856024|O2|Outcome|Re-treatment|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had been considered nonresponders or relapsing to prior treatment for chronic hepatitis C. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983873|NCT00856024|O1|Outcome|Naïve Participants|Participants, from Brazil, with confirmed chronic hepatitis C and who completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin and who previous to this treatment had not been treated with peginterferon alfa-2b. Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983874|NCT00856024|E1|Reported Event|General Peginterferon + Ribavarin|Participants received peginterferon alfa-2b and ribavirin according to local labeling guidelines and according to the investigating physician's orientation.
983875|NCT00855959|B1|Baseline|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983876|NCT00855959|P1|Participant Flow|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983877|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983878|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983879|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983880|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983881|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983882|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983883|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983884|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983885|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983886|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983887|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983888|NCT00855959|O1|Outcome|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983889|NCT00855959|E1|Reported Event|Pulmicort Turbuhaler and Pulmicort Respules|4 weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
983890|NCT00855933|B3|Baseline|Total|Total of all reporting groups
983891|NCT00855933|B2|Baseline|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983892|NCT00855933|B1|Baseline|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983893|NCT00855933|P2|Participant Flow|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983894|NCT00855933|P1|Participant Flow|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983895|NCT00855933|O2|Outcome|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983896|NCT00855933|O1|Outcome|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983897|NCT00855933|E2|Reported Event|Brushing + Flossing|Experimental - Subjects will floss once daily with the experimental floss. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983898|NCT00855933|E1|Reported Event|Brushing Only|Control - Subjects will refrain from flossing. Subjects will brush teeth Crest® Cavity Protection toothpaste and Oral-B® Indicator soft, manual toothbrush once daily.
983899|NCT00855920|B4|Baseline|Total|Total of all reporting groups
983900|NCT00855920|B3|Baseline|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
983901|NCT00855920|B2|Baseline|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983902|NCT00855920|B1|Baseline|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983903|NCT00855920|P3|Participant Flow|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
983904|NCT00855920|P2|Participant Flow|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983905|NCT00855920|P1|Participant Flow|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983906|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
983907|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983908|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983909|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
983910|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983911|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983912|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
983913|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983914|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983915|NCT00855920|O3|Outcome|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
983916|NCT00855920|O2|Outcome|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983917|NCT00855920|O1|Outcome|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
983918|NCT00855920|E3|Reported Event|Rilonacept and Placebo (for Indomethacin)|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
983919|NCT00855920|E2|Reported Event|Rilonacept and Indomethacin|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in arm (Placebo [for Rilonacept] and Indomethacin).
983920|NCT00855920|E1|Reported Event|Placebo (for Rilonacept) and Indomethacin|Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). One participant randomized to treatment for Rilonacept and Indomethacin, received treatment for Placebo [for Rilonacept] and Indomethacin and analyzed in this arm.
983921|NCT00855894|B1|Baseline|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983922|NCT00855894|P1|Participant Flow|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983923|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983924|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983925|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983965|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983926|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983927|NCT00855894|O1|Outcome|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983928|NCT00855894|E1|Reported Event|Pertuzumab + Erlotinib|Patients received pertuzumab 840 mg intravenously (IV) 1 time (loading dose) followed by 420 mg IV (maintenance dose) every 3 weeks (q3w) plus erlotinib 150 mg orally once a day which was reduced to 100 mg orally once a day in a protocol amendment dated 19 May 2010.
983929|NCT00855868|B3|Baseline|Total|Total of all reporting groups
983930|NCT00855868|B2|Baseline|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
983931|NCT00855868|B1|Baseline|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
983932|NCT00855868|P2|Participant Flow|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
983933|NCT00855868|P1|Participant Flow|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
983934|NCT00855868|O2|Outcome|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
983935|NCT00855868|O1|Outcome|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
983936|NCT00855868|E2|Reported Event|Healthy Controls|Cognitively normal with MMSE of 27 or higher, CDR=0, no symptoms of depression and age 55-90 years.
983937|NCT00855868|E1|Reported Event|Alzheimer's Disease|Mini-mental state examination (MMSE) 18-26, clinical dementia rating (CDR) >=0.5, University of Pennsylvania Alzheimer's Disease Center consensus diagnosis of probable AD, absence of abnormalities on MRI and age 55-90
983938|NCT00855842|B1|Baseline|Osmotic Dilator|osmotic dilator
983939|NCT00855842|P1|Participant Flow|Osmotic Dilator|osmotic dilator
983940|NCT00855842|O1|Outcome|Osmotic Dilator|osmotic dilator
983941|NCT00855842|E1|Reported Event|Osmotic Dilator|osmotic dilator
983942|NCT00855816|B3|Baseline|Total|Total of all reporting groups
983943|NCT00855816|B2|Baseline|Treatment as Usual|No intervention: Treatment as usual
983944|NCT00855816|B1|Baseline|Breathing Training|relaxation training
983945|NCT00855816|P2|Participant Flow|Treatment as Usual|No intervention - treatment as usual
983946|NCT00855816|P1|Participant Flow|Breathing Training|relaxation training
983947|NCT00855816|O2|Outcome|Treatment as Usual|No intervention: treatment as usual
983948|NCT00855816|O1|Outcome|Breathing Training|relaxation training
983949|NCT00855816|E2|Reported Event|Treatment as Usual|No intervention: Treatment as usual
983950|NCT00855816|E1|Reported Event|Breathing Training|relaxation training
983951|NCT00855738|B1|Baseline|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983952|NCT00855738|P1|Participant Flow|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983953|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983954|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983955|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983956|NCT00855738|O1|Outcome|All Antiepileptic Drugs|
983957|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983958|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983959|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983960|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983961|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983962|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983963|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983964|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
984057|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
990645|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
983967|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983968|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983969|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983970|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983971|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983972|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983973|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983974|NCT00855738|O1|Outcome|All Antiepileptic Drugs|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin: treatment, dose and frequency of administration determined by daily clinical practice
983975|NCT00855738|E2|Reported Event|Pregabalin (Pregabalin Only)|
983976|NCT00855738|E1|Reported Event|All Antiepileptic Drugs (Including Pregabalin)|Pregabalin, Levetiracetam, Topiramate, Lamotrigine, Oxcarbazepine, Zonisamide, Gabapentin
983977|NCT00855595|B3|Baseline|Total|Total of all reporting groups
983978|NCT00855595|B2|Baseline|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983979|NCT00855595|B1|Baseline|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983980|NCT00855595|P2|Participant Flow|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983981|NCT00855595|P1|Participant Flow|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983982|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983983|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983984|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983985|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983986|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983987|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983988|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983989|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983990|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983991|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983992|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983993|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983994|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983995|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983996|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983997|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
983998|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
983999|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984000|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
984001|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984002|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
984003|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984004|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
984005|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984006|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
984007|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984008|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
984009|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984010|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
984011|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984012|NCT00855595|O2|Outcome|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and doxycycline 40 mg once daily for 12 weeks
984013|NCT00855595|O1|Outcome|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and doxycycline 40 mg once daily for 12 weeks
984014|NCT00855595|E2|Reported Event|Metronidazole (Metrogel) Plus Doxycycline (Oracea)|Participants received topical metronidazole 1% gel once daily and systemic doxycycline 40 mg once daily for 12 weeks
984015|NCT00855595|E1|Reported Event|Azelaic Acid (Finacea, BAY39-6251) Plus Doxycycline (Oracea)|Participants received topical azelaic acid gel 15% twice daily and systemic doxycycline 40 mg once daily for 12 weeks
984016|NCT00855582|B4|Baseline|Total|Total of all reporting groups
984017|NCT00855582|B3|Baseline|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984018|NCT00855582|B2|Baseline|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984019|NCT00855582|B1|Baseline|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984020|NCT00855582|P3|Participant Flow|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984021|NCT00855582|P2|Participant Flow|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984022|NCT00855582|P1|Participant Flow|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984023|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984024|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984025|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984026|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984027|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984028|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984029|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984030|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984031|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984032|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984033|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984034|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984035|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984036|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984037|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984038|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984039|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984040|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984041|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984042|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984043|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984044|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984045|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984046|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984047|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984048|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984049|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984050|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984051|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984052|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984053|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984054|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984055|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984056|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984059|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
1025166|NCT00757848|O1|Outcome|AZD9668|AZD9668, 2 x 30 mg twice daily (bid)
984062|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984063|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984064|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984065|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984066|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984067|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984068|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984069|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984070|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984071|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984072|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984073|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984074|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984075|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984076|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984077|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984078|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984079|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984080|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984081|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984082|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984083|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984084|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984085|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984086|NCT00855582|O3|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984087|NCT00855582|O2|Outcome|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984088|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984089|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984090|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
984091|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984092|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
984093|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984094|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
984095|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984096|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
984097|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984098|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
984099|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984100|NCT00855582|O1|Outcome|Tadalafil 2.5 mg|Tablet once daily by mouth for 12 weeks.
984101|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984102|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
984103|NCT00855582|O2|Outcome|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984104|NCT00855582|O1|Outcome|Tadalafil 5 mg|Tablet once daily by mouth for 12 weeks.
984105|NCT00855582|E3|Reported Event|Placebo|Matching placebo tablet once daily by mouth for 12 weeks.
984106|NCT00855582|E2|Reported Event|Tadalafil 5 mg|5 mg tablet once daily by mouth for 12 weeks.
984107|NCT00855582|E1|Reported Event|Tadalafil 2.5 mg|2.5 mg tablet once daily by mouth for 12 weeks.
984108|NCT00855465|B3|Baseline|Total|Total of all reporting groups
984109|NCT00855465|B2|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984110|NCT00855465|B1|Baseline|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984111|NCT00855465|P2|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984112|NCT00855465|P1|Participant Flow|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984113|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984114|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984115|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984116|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984265|NCT00855062|B1|Baseline|Minocycline|Minocycline 100 mg orally every 12 hours
984117|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984266|NCT00855062|P2|Participant Flow|Placebo|Placebo minocycline capsules every 12 hours
984267|NCT00855062|P1|Participant Flow|Minocycline|Minocycline 100 mg orally every 12 hours
984118|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984119|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984120|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984121|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984122|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984123|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984124|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984125|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984126|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984127|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984128|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984129|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984130|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984131|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984132|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984133|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984134|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984135|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984136|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984137|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984138|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984139|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984140|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984141|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984142|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984143|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984144|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984145|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984146|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984147|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984148|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984149|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984183|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984268|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984150|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984151|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984152|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984153|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984154|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984155|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984156|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984157|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984158|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984159|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984160|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984161|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984162|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984163|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984164|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984165|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984166|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984167|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984168|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984169|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984170|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984171|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984172|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984173|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984174|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984175|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984176|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984177|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984178|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984179|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984180|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984181|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984182|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984184|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984185|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984186|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984187|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984188|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984189|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984190|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984191|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984192|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984193|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984194|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984195|NCT00855465|O2|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984196|NCT00855465|O1|Outcome|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984197|NCT00855465|E2|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 16 weeks
984198|NCT00855465|E1|Reported Event|Riociguat (Adempas, BAY63-2521)_individual Dose Titration|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 16 weeks
984199|NCT00855439|B3|Baseline|Total|Total of all reporting groups
984200|NCT00855439|B2|Baseline|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
984201|NCT00855439|B1|Baseline|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
984202|NCT00855439|P2|Participant Flow|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
984203|NCT00855439|P1|Participant Flow|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
984204|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
984205|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
984206|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
984207|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
984208|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
984209|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
984210|NCT00855439|O2|Outcome|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
984211|NCT00855439|O1|Outcome|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
984212|NCT00855439|E2|Reported Event|Glargine|"Subjects will take 1 daily injection of insulin glargine for 18 months.~Glargine: Subjects will take 1 daily injection of insulin glargine in manner consistent with current prescribing guidelines. Glargine and other diabetes medications will be adjusted to achieve optimal levels of blood sugar control"
984213|NCT00855439|E1|Reported Event|Exenatide|"Subjects will take exenatide by subcutaneous injection twice daily for 18 months~Exenatide: Exenatide is given according to current FDA prescribing guidelines. Exenatide and other diabetes medications will be titrated in order to achieve optimal blood glucose levels"
984214|NCT00855309|B3|Baseline|Total|Total of all reporting groups
984215|NCT00855309|B2|Baseline|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
984216|NCT00855309|B1|Baseline|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
984217|NCT00855309|P2|Participant Flow|Low-dose IV Acyclovir|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
984218|NCT00855309|P1|Participant Flow|Weight-based IV Acyclovir|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
984219|NCT00855309|O2|Outcome|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
984220|NCT00855309|O1|Outcome|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
984221|NCT00855309|E2|Reported Event|Arm II|Patients receive low-dose IV acyclovir sodium every 8 or 12 hours.
984222|NCT00855309|E1|Reported Event|Arm I|Patients receive weight-based IV acyclovir sodium every 8 or 12 hours.
984223|NCT00855218|B3|Baseline|Total|Total of all reporting groups
984224|NCT00855218|B2|Baseline|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984225|NCT00855218|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984226|NCT00855218|P2|Participant Flow|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984227|NCT00855218|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with doxorubicin capable beads (DC Bead) (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984228|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984229|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984230|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984231|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984232|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984261|NCT00855166|E2|Reported Event|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
984262|NCT00855166|E1|Reported Event|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
984263|NCT00855062|B3|Baseline|Total|Total of all reporting groups
984264|NCT00855062|B2|Baseline|Placebo|Placebo minocycline capsules every 12 hours
984233|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984234|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984235|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984236|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984237|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984238|NCT00855218|O2|Outcome|Placebo + TACE|Placebo was to be orally administered as 2 tablets bid (twice daily). Participants were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984239|NCT00855218|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + TACE|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Participants were then also treated with Transarterial Chemoembolization (TACE) performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib, TACE was also performed on Days 1 (+ 4 days) of cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984240|NCT00855218|E2|Reported Event|Placebo|Placebo was to be orally administered as 2 tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of placebo on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984241|NCT00855218|E1|Reported Event|Sorafenib (Nexavar, BAY 43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Patients were then also treated with TACE performed with DC Bead (300 to 500 microns) and doxorubicin (150 mg) between 3 to 7 days after the first dose of sorafenib on cycle 1, 3, 7, 13 and then every 6 cycles thereafter (an optional TACE procedure could be performed between Day 1 of Cycle 7 and Cycle 13 and between Day 1 of Cycles 13 and 19, if deemed necessary by the Investigator.)
984242|NCT00855166|B3|Baseline|Total|Total of all reporting groups
984243|NCT00855166|B2|Baseline|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
984244|NCT00855166|B1|Baseline|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
984245|NCT00855166|P2|Participant Flow|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
984246|NCT00855166|P1|Participant Flow|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
984247|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
984248|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
984249|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
984250|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
984251|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 102 weeks
984252|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 102 weeks
984253|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
984254|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
984255|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
984256|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
984257|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
984258|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
984259|NCT00855166|O2|Outcome|Dapagliflozin Plus Metformin|Dapagliflozin 10 mg oral once daily plus metformin over 24 weeks
984260|NCT00855166|O1|Outcome|Placebo Plus Metformin|Placebo oral once daily plus metformin over 24 weeks
984269|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984270|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984271|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984272|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984273|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984274|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984275|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984276|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984277|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984278|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984279|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984280|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984281|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984282|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984283|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984284|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984285|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984286|NCT00855062|O2|Outcome|Placebo|Placebo minocycline capsules every 12 hours
984287|NCT00855062|O1|Outcome|Minocycline|Minocycline 100 mg orally every 12 hours
984288|NCT00855062|E2|Reported Event|Placebo|Placebo minocycline capsules every 12 hours
984289|NCT00855062|E1|Reported Event|Minocycline|Minocycline 100 mg orally every 12 hours
984290|NCT00854906|B1|Baseline|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). All study participants participated in both the KTBUT Study Arm and the FTBUT Study Arm.
984291|NCT00854906|P1|Participant Flow|All Study Participants|These are the total number of study participants whose tear break up times were measured with a keratometer (KTBUT) and fluorescein dye (FTBUT). Both KTBUT and FTBUT were measured in all study participants.
984292|NCT00854906|O1|Outcome|All Study Participants|
984293|NCT00854906|O2|Outcome|FTBUT|
984294|NCT00854906|O1|Outcome|KTBUT|
984295|NCT00854906|E2|Reported Event|FTBUT|
984296|NCT00854906|E1|Reported Event|KTBUT|
984297|NCT00854724|B3|Baseline|Total|Total of all reporting groups
984298|NCT00854724|B2|Baseline|Puerarin, Then Placebo|
984299|NCT00854724|B1|Baseline|Placebo, Then Puerarin|
984300|NCT00854724|P2|Participant Flow|Puerarin, Then Placebo|
984301|NCT00854724|P1|Participant Flow|Placebo, Then Puerarin|
984302|NCT00854724|O2|Outcome|Puerarin, Then Placebo|
984303|NCT00854724|O1|Outcome|Placebo, Then Puerarin|
984304|NCT00854724|E2|Reported Event|Puerarin, Then Placebo|
984305|NCT00854724|E1|Reported Event|Placebo, Then Puerarin|
984306|NCT00854620|B1|Baseline|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
984307|NCT00854620|P1|Participant Flow|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
984308|NCT00854620|O1|Outcome|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
984309|NCT00854620|E1|Reported Event|Sorafenib|"Cycle 1: 400 mg BID sorafenib~Cycle 2: 600 mg BID sorafenib~Cycle 3+: 800 mg BID sorafenib~Sorafenib: Sorafenib administered in escalating 28-days cycles (400, 600 and 800 mg BID)"
984310|NCT00854607|B1|Baseline|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
984311|NCT00854607|P1|Participant Flow|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven Invasive Aspergillosis (IA) infection, were started on standard of care antifungal therapy. Within 14 days of the start of therapy participants were re-evaluated, and those diagnosed with possible IA were discontinued from the study, while those with probable and proven IA were defined as the baseline population
984312|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
984313|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
984314|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984315|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984316|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
984317|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
984318|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984319|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984320|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
990646|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
984321|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
984322|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984323|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984324|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 12.
984325|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
984326|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984327|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984328|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
984329|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
984330|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
984331|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
984332|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 12.
984333|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 12.
984334|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984335|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984336|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984337|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984338|NCT00854607|O2|Outcome|Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984339|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care antifungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984340|NCT00854607|O2|Outcome|Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Responders at Week 6.
984341|NCT00854607|O1|Outcome|Non-Responders|Participants started on standard of care anti-fungal therapy on Day 0 who were diagnosed as Non-Responders at Week 6.
984342|NCT00854607|E1|Reported Event|Invasive Aspergillosis|Participants who enrolled with a presumptive diagnosis of possible, probable or proven IA infection, and were started on standard of care antifungal therapy.
984343|NCT00854594|B3|Baseline|Total|Total of all reporting groups
984344|NCT00854594|B2|Baseline|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
984345|NCT00854594|B1|Baseline|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
984346|NCT00854594|P2|Participant Flow|ReSPECT Intervention|"Providers within sites randomized to the intervention arm will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention Community-Based Outpatient Clinics (CBOCs) by modeling interprofessional team practices during SMAs for diabetes mellitus (DM) patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
984347|NCT00854594|P1|Participant Flow|Control|Providers within sites randomized to the control arm will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
984348|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
984349|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
984371|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
984372|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
984373|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
984350|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
984351|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
984352|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
984353|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
984354|NCT00854594|O2|Outcome|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
984355|NCT00854594|O1|Outcome|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
984356|NCT00854594|E2|Reported Event|ReSPECT Intervention|"Intervention sites will receive baseline measures pre and post, but also in-depth Shared Medical Appointments (SMA)(The Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT) intervention) and at 15 months SMA video conferences. At the end of the 18 months the randomly selected patients and providers will be asked to take part in a qualitative interview.~Role modeling in Shared medical appointments to Promote Establishing Collaborative Teams (ReSPECT): The intervention is designed to educate the clinicians at intervention CBOCs by modeling interprofessional team practices during SMAs for DM patients from each CBOC primary care provider's (PCP) patient panel. We hypothesize that this education at intervention CBOCs will improve interprofessional practices and overall quality care delivered to veterans."
984357|NCT00854594|E1|Reported Event|Control|Control sites will receive the baseline measures pre and post. These sites will receive traditional diabetes education, which includes teleconsultation.
984358|NCT00854581|B1|Baseline|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
984359|NCT00854581|P1|Participant Flow|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
984360|NCT00854581|O1|Outcome|Induction + Maintenance Therapy|All patients are enrolled to induction therapy phase, then move to the maintenance therapy phase if they achieve complete response (PR) or partial response (PR)
984361|NCT00854581|E2|Reported Event|Maintenance Therapy|"Zidovudine + Interferon alfa-2b + PEG Interferon alfa-2b~PEG-interferon alfa-2b: PEG-IFN-alfa2b 1.5 ug/kg SQ weekly.~Interferon alfa-2b: Days 3 - 14: Interferon Alpha-2b 5 10 million units IV twice daily.~Valproic Acid: Patients will be started on one capsule (250 mg) with water twice daily.~Zidovudine: Days 1-2: (0-48 hours) Zidovudine (AZT) 1.5 grams intravenously (IV) twice daily. Days 3-14: Zidovudine (AZT) 1.5 grams IV twice daily and Interferon Alpha-2b 5 10 million units IV twice daily. Subsequent doses dependent on patient response.~Molecular Evaluation/Analysis of Malignant Clones of ATLL: Blood Sample - Baseline/Pre-Treatment, months 3 and 6, End of Month 12, Disease Progession"
984362|NCT00854581|E1|Reported Event|Induction Therapy|"Zidovudine + Interferon alfa-2b~Interferon alfa-2b: Days 3 - 14: Interferon Alpha-2b 5 10 million units IV twice daily.~Zidovudine: Days 1-2: (0-48 hours) Zidovudine (AZT) 1.5 grams intravenously (IV) twice daily. Days 3-14: Zidovudine (AZT) 1.5 grams IV twice daily and Interferon Alpha-2b 5 10 million units IV twice daily. Subsequent doses dependent on patient response.~NF-kB Inhibition: Blood Sample - Baseline/Pre-Treatment, Induction,"
984363|NCT00854373|B3|Baseline|Total|Total of all reporting groups
984364|NCT00854373|B2|Baseline|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
984365|NCT00854373|B1|Baseline|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
984366|NCT00854373|P2|Participant Flow|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
984367|NCT00854373|P1|Participant Flow|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
984368|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
984369|NCT00854373|O1|Outcome|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
984370|NCT00854373|O2|Outcome|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
984374|NCT00854373|E2|Reported Event|Placebo|"Saline~Saline ( placebo) : 1 cc of Normal Saline (placebo) given at the same time as HCG ovulation trigger."
984375|NCT00854373|E1|Reported Event|Bravelle|"Bravelle~Bravelle(follicle stimulating hormone) : One dose of 6 amps of Bravelle given at the same time as HCG ovulation trigger."
984376|NCT00854360|B5|Baseline|Total|Total of all reporting groups
984377|NCT00854360|B4|Baseline|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984378|NCT00854360|B3|Baseline|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984379|NCT00854360|B2|Baseline|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984380|NCT00854360|B1|Baseline|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
984381|NCT00854360|P4|Participant Flow|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984382|NCT00854360|P3|Participant Flow|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984383|NCT00854360|P2|Participant Flow|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984384|NCT00854360|P1|Participant Flow|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 micrograms (µg) beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) and two actuations of placebo HFA once daily.
984385|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984386|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984387|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984388|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
984389|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984390|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984391|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984392|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
984393|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984394|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984395|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984396|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
984397|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984398|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984399|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984400|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
984401|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984402|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984403|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984404|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
984405|NCT00854360|O4|Outcome|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984406|NCT00854360|O3|Outcome|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984407|NCT00854360|O2|Outcome|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
990647|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
984408|NCT00854360|O1|Outcome|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
985493|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
984409|NCT00854360|E4|Reported Event|Placebo|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of placebo HFA once daily.
984410|NCT00854360|E3|Reported Event|BDP HFA 320 µg/Day|During the 2-week double-blind Treatment Period participants self-administered 4 actuations (two per nostril) of 80 µg BDP HFA once daily.
984411|NCT00854360|E2|Reported Event|BDP HFA 160 µg/Day|During the 2-week double-blind Treatment Period participants self-administered four actuations (two per nostril) of 40 µg BDP HFA once daily.
984412|NCT00854360|E1|Reported Event|BDP HFA 80 µg/Day|During the 2-week double-blind Treatment Period participants self-administered two actuations (one per nostril) of 40 (µg) BDP HFA and two actuations of placebo HFA once daily.
984413|NCT00854308|B3|Baseline|Total|Total of all reporting groups
984414|NCT00854308|B2|Baseline|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984415|NCT00854308|B1|Baseline|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984416|NCT00854308|P2|Participant Flow|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984417|NCT00854308|P1|Participant Flow|MetMAb + Erlotinib|MetMab (a monovalent antagonist antibody to the receptor MET) 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984418|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984419|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984420|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984421|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984422|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984423|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984424|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984425|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984426|NCT00854308|O2|Outcome|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984427|NCT00854308|O1|Outcome|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984428|NCT00854308|E2|Reported Event|Placebo + Erlotinib|Placebo IV infusion every 3 weeks + Erlotinib 150 mg orally daily until progression of disease or unacceptable toxicity.
984429|NCT00854308|E1|Reported Event|MetMAb + Erlotinib|MetMab 15 mg/kg intravenous (IV) infusion every 3 weeks + Erlotinib 150 mg orally once daily until progression of disease or unacceptable toxicity.
984430|NCT00854113|B12|Baseline|Total|Total of all reporting groups
984431|NCT00854113|B11|Baseline|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984432|NCT00854113|B10|Baseline|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984433|NCT00854113|B9|Baseline|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984434|NCT00854113|B8|Baseline|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984435|NCT00854113|B7|Baseline|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984436|NCT00854113|B6|Baseline|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984437|NCT00854113|B5|Baseline|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984438|NCT00854113|B4|Baseline|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984439|NCT00854113|B3|Baseline|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984440|NCT00854113|B2|Baseline|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984441|NCT00854113|B1|Baseline|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984442|NCT00854113|P11|Participant Flow|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984443|NCT00854113|P10|Participant Flow|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984444|NCT00854113|P9|Participant Flow|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984445|NCT00854113|P8|Participant Flow|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984446|NCT00854113|P7|Participant Flow|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984447|NCT00854113|P6|Participant Flow|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984448|NCT00854113|P5|Participant Flow|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984449|NCT00854113|P4|Participant Flow|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984450|NCT00854113|P3|Participant Flow|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984451|NCT00854113|P2|Participant Flow|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
1025676|NCT00756444|B3|Baseline|Total|Total of all reporting groups
984452|NCT00854113|P1|Participant Flow|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984453|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984454|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984455|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984456|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984457|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984458|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984459|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984460|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984461|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984462|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984463|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984464|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984465|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984466|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984467|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984468|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984469|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984470|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984471|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984472|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984473|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984474|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984475|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984476|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984477|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984478|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984479|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984480|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984481|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984482|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984483|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984484|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984485|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984486|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984487|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984488|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984489|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984490|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984491|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984492|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984493|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984494|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984495|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984496|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984497|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984498|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984499|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984500|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984501|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
990648|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
984502|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984503|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984504|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984505|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984506|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984507|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984508|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984509|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984510|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984511|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984512|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984513|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984514|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984515|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984516|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984517|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984518|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984519|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984520|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984521|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984522|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984523|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984524|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984525|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984526|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984527|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984528|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984529|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984530|NCT00854113|O11|Outcome|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984531|NCT00854113|O10|Outcome|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984532|NCT00854113|O9|Outcome|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984533|NCT00854113|O8|Outcome|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984534|NCT00854113|O7|Outcome|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984535|NCT00854113|O6|Outcome|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984536|NCT00854113|O5|Outcome|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984537|NCT00854113|O4|Outcome|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984538|NCT00854113|O3|Outcome|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984539|NCT00854113|O2|Outcome|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984540|NCT00854113|O1|Outcome|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984541|NCT00854113|E11|Reported Event|Part 2 - Multiple Dose Placebo|Placebo group- received placebo capsules for 14 days
984542|NCT00854113|E10|Reported Event|Part 2 - Multiple Dose EGT0001474 150mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 150mg
984543|NCT00854113|E9|Reported Event|Part 2 - Multiple Dose EGT0001474 50 mg|Treatment group-received 14 daily doses of EGT0001474 at the dose of 50mg
984544|NCT00854113|E8|Reported Event|Part 2 - Mutiple Dose EGT0001474 10 mg|Treatment group- received 14 daily doses of EGT0001474 at the dose of 10mg
984545|NCT00854113|E7|Reported Event|Part 1 - Single Dose Placebo|Placebo group- received single dose of placebo capsule
984546|NCT00854113|E6|Reported Event|Part 1 - Single Dose EGT0001474 150mg|Treatment group- received 150 mg single dose of EGT0001474
984547|NCT00854113|E5|Reported Event|Part 1 - Single Dose EGT0001474 75 mg|Treatment group- received 75 mg single dose of EGT0001474
984548|NCT00854113|E4|Reported Event|Part 1 - Single Dose EGT0001474 25 mg|Treatment group- received 25 mg single dose of EGT0001474
984549|NCT00854113|E3|Reported Event|Part 1 -Single Dose EGT0001474 10 mg|Treatment group- received 10 mg single dose of EGT0001474
984550|NCT00854113|E2|Reported Event|Part 1 - Single Dose EGT0001474 5 mg|Treatment group- received 5 mg single dose of EGT0001474
984551|NCT00854113|E1|Reported Event|Part 1 - Single Dose EGT0001474 2.5 mg|Treatment group - received 2.5 mg single dose of EGT0001474
984552|NCT00854087|B3|Baseline|Total|Total of all reporting groups
985486|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985120|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
984553|NCT00854087|B2|Baseline|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
984554|NCT00854087|B1|Baseline|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
984555|NCT00854087|P2|Participant Flow|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
984556|NCT00854087|P1|Participant Flow|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
984557|NCT00854087|O2|Outcome|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
984558|NCT00854087|O1|Outcome|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
984559|NCT00854087|E2|Reported Event|Placebo|"Pill without Fuzheng Huayu (sugar pill)~Placebo: The subjects will be taking 2 tablets three times a day for 48 weeks."
984560|NCT00854087|E1|Reported Event|Fuzheng Huayu|"Pill with Fuzheng Huayu~Fuzheng Huayu: The subjects will be taking 2 tablets three times a day for 48 weeks."
984561|NCT00853996|B1|Baseline|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
984562|NCT00853996|P1|Participant Flow|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
984563|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
984564|NCT00853996|O1|Outcome|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
984565|NCT00853996|E1|Reported Event|Prevention (Acolbifene Hydrochloride)|"Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.~acolbifene hydrochloride: Given orally"
984566|NCT00853970|B3|Baseline|Total|Total of all reporting groups
984567|NCT00853970|B2|Baseline|Placebo|one drop daily in study eye for 2 weeks
984568|NCT00853970|B1|Baseline|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
984569|NCT00853970|P2|Participant Flow|Placebo|dosed 1 drop daily into the study eye for 2 weeks
984570|NCT00853970|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.09%|dosed 1 drop daily into the study eye for 2 weeks
984571|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
984572|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
984573|NCT00853970|O2|Outcome|Placebo|one drop daily in study eye for 2 weeks
984574|NCT00853970|O1|Outcome|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
984575|NCT00853970|E2|Reported Event|Placebo|one drop daily in study eye for 2 weeks
984576|NCT00853970|E1|Reported Event|Bromfenac Ophthalmic Solution 0.09%|one drop daily in study eye for 2 weeks
984577|NCT00853957|B3|Baseline|Total|Total of all reporting groups
984578|NCT00853957|B2|Baseline|Amlodipine|Amlodipine 5mg titrated to 10 mg
984579|NCT00853957|B1|Baseline|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984580|NCT00853957|P2|Participant Flow|Amlodipine|Amlodipine 5mg titrated to 10 mg
984581|NCT00853957|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984582|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
984583|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984584|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
984585|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984586|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
984587|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984588|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
984589|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984590|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
984591|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984592|NCT00853957|O2|Outcome|Amlodipine|Amlodipine 5mg titrated to 10 mg
984593|NCT00853957|O1|Outcome|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984594|NCT00853957|E2|Reported Event|Amlodipine|Amlodipine 5mg titrated to 10 mg
984595|NCT00853957|E1|Reported Event|Aliskiren/Amlodipine|Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
984596|NCT00853905|B3|Baseline|Total|Total of all reporting groups
984597|NCT00853905|B2|Baseline|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
984598|NCT00853905|B1|Baseline|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
984599|NCT00853905|P2|Participant Flow|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
984600|NCT00853905|P1|Participant Flow|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
985487|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
984601|NCT00853905|O2|Outcome|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
984602|NCT00853905|O1|Outcome|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
984603|NCT00853905|E2|Reported Event|Treatment 2 (Balanced Salt Solution BSS)|"glaucoma surgery with balanced salt solution, the standard technique used.~balanced salt solution BSS: standard technique for glaucoma surgery . At the end of the case anterior chamber will be reformed with balanced salt solution to adequate intraocular pressure."
984604|NCT00853905|E1|Reported Event|Treatment 1(Triesence)|"0.2cc Triesence~Triesence: At the end of standard glaucoma surgery after the anterior chamber is reformed with balanced salt solution or viscoelastic to adequate intraocular pressure; 0.2cc of Triesence will be delivered into the anterior chamber through the previously created paracentesis wound"
984605|NCT00853840|B1|Baseline|All Subjects|In this 2-way crossover study, in Period 1, all 18 subjects were randomized to receive a single dose of either vardenafil 20 mg (Treatment A) or placebo (Treatment B), subsequent to treatment with 3 to 4 days of maraviroc 300 mg BID. All subjects were then crossed over to receive the second treatment in Period 2.
984606|NCT00853840|P2|Participant Flow|Non-matching Placebo + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
984607|NCT00853840|P1|Participant Flow|Vardenafil + Maraviroc|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
984608|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
984609|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
984610|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
984611|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
984612|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
984613|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
984614|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
984615|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
984616|NCT00853840|O2|Outcome|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of a non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
984617|NCT00853840|O1|Outcome|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
984618|NCT00853840|E3|Reported Event|Maraviroc + Placebo (Treatment B)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of non-matching placebo tablet was administered orally 1 hour post maraviroc dosing.
984619|NCT00853840|E2|Reported Event|Maraviroc + Vardenafil (Treatment A)|On Days 1 through 3 during Period 1, and Days 1 through 2 during Period 2, a maraviroc 300 mg tablet was to be taken orally BID to achieve steady state. On Day 4 of Period 1, and Day 3 of Period 2, a single dose of vardenafil 20 mg tablet was administered orally 1 hour post maraviroc dosing.
984620|NCT00853840|E1|Reported Event|Maraviroc Run-In|All subjects received 3 to 4 days of maraviroc 300 mg twice daily (BID) before receiving single oral doses of either vardenafil 20 mg (Treatment A) or placebo (Treatment B).
984621|NCT00853827|B3|Baseline|Total|Total of all reporting groups
984622|NCT00853827|B2|Baseline|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
984623|NCT00853827|B1|Baseline|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
984624|NCT00853827|P2|Participant Flow|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
984625|NCT00853827|P1|Participant Flow|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
984626|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
984627|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
984628|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
984629|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
984630|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
984631|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
984632|NCT00853827|O2|Outcome|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
984633|NCT00853827|O1|Outcome|Aliskiren|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
984634|NCT00853827|E2|Reported Event|Placebo|Period 1(Screening Period) visit 1(Day -42 to Day -1) eligibility for study participation was assessed. Period 2: visit 2 to 3, single blind for 1 week: patients received 1 tablet aliskiren 150 mg, 1 tablet placebo 150 mg. Period 3: visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets placebo 150 mg
984635|NCT00853827|E1|Reported Event|Aliskiren 300 mg|Visit 2 to 3, single blind for 1 week: patients received aliskiren 150 mg. visit 3 to 15, Double-blind Randomization/Forced Titration and Maintenance Period for 103 weeks: patients received 2 tablets aliskiren 150 mg (force titration)
984636|NCT00853762|B5|Baseline|Total|Total of all reporting groups
984637|NCT00853762|B4|Baseline|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984638|NCT00853762|B3|Baseline|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984639|NCT00853762|B2|Baseline|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984640|NCT00853762|B1|Baseline|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984641|NCT00853762|P4|Participant Flow|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984642|NCT00853762|P3|Participant Flow|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
985488|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
984643|NCT00853762|P2|Participant Flow|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984644|NCT00853762|P1|Participant Flow|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 milligram (mg) subcutaneously (SC) as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984645|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984646|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984647|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984648|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984649|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984650|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984651|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984652|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984653|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984654|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984655|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984656|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984657|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984658|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984659|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984660|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984661|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984662|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984663|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
990649|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
984664|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984665|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984666|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984667|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984668|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984669|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984670|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984671|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984672|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984673|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984674|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984675|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984676|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984677|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984678|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984679|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984680|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984681|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984682|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984683|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984684|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
985489|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
984685|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984686|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984687|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984688|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984689|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984690|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984691|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984692|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984693|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984694|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984695|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984696|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984697|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984698|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984699|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984700|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984701|NCT00853762|O4|Outcome|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984702|NCT00853762|O3|Outcome|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984703|NCT00853762|O2|Outcome|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984704|NCT00853762|O1|Outcome|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984705|NCT00853762|E4|Reported Event|Atacicept 150 mg (Without Loading)|Subjects who received placebo SC as loading dose twice weekly for first 4 weeks, followed by placebo SC for 32 weeks, in 28063 study were continued with atacicept 150 mg (without loading dose) SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
990650|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
984706|NCT00853762|E3|Reported Event|Atacicept 150 mg (With Loading)|Subjects who received atacicept 150 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 150 mg SC for 32 weeks, in 28063 study were continued with atacicept 150 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984707|NCT00853762|E2|Reported Event|Atacicept 75 mg (With Loading)|Subjects who received atacicept 75 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 75 mg SC for 32 weeks, in 28063 study were continued with atacicept 75 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984708|NCT00853762|E1|Reported Event|Atacicept 25 mg (With Loading)|Subjects who received atacicept 25 mg SC as loading dose twice weekly for first 4 weeks, followed by atacicept 25 mg SC for 32 weeks, in 28063 study were continued with atacicept 25 mg SC once weekly up to 5 years or up to early termination of treatment or early termination of the study.
984709|NCT00853749|B3|Baseline|Total|Total of all reporting groups
984710|NCT00853749|B2|Baseline|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984711|NCT00853749|B1|Baseline|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984712|NCT00853749|P2|Participant Flow|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984713|NCT00853749|P1|Participant Flow|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984714|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984715|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984716|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984717|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984718|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984719|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984720|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984721|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984722|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984723|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984724|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984725|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
984726|NCT00853749|O2|Outcome|PCV/PCV/13vPnC|For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).
984727|NCT00853749|O1|Outcome|PCV/23vPS/13vPnC|For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).
985116|NCT00853242|O1|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
984728|NCT00853749|E2|Reported Event|PCV/PCV/13vPnC|"For this study, participants received a single dose of 13vPnC. Participants must have also previously received 9V-MnCC followed by a toddler dose of 9V-MnCC (also referred to as PCV).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Local Reactions N=30; systematic (solicited) Systemic Events N=5."
984729|NCT00853749|E1|Reported Event|PCV/23vPS/13vPnC|"For this study, participants received a single dose of 13-valent pneumococcal conjugate vaccine (13vPnC). Participants previously must have also received an infant series of 9-valent pneumococcal-conjugate-meningococcal serogroup C conjugate combination vaccine (9V-MnCC) also known as pneumococcal conjugate vaccine (PCV) followed by a toddler dose of 23-valent pneumococcal polysaccharide vaccine (23vPS).~Other AEs (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=8; systematic (solicited) Local Reactions N=44; systematic (solicited) Systemic Events N=9."
984730|NCT00853723|B4|Baseline|Total|Total of all reporting groups
984731|NCT00853723|B3|Baseline|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984732|NCT00853723|B2|Baseline|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984733|NCT00853723|B1|Baseline|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984734|NCT00853723|P3|Participant Flow|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984735|NCT00853723|P2|Participant Flow|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984736|NCT00853723|P1|Participant Flow|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984737|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
984738|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
984739|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
984740|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
984741|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
984742|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
984743|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
984744|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
984745|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
984746|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
984747|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
984748|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
984749|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
984750|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
984751|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
984752|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
984753|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
984754|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
984755|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984756|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984757|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984758|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984759|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984760|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
985117|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
984761|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984762|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984763|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984764|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984765|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984766|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984767|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984768|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984769|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984770|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984771|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984772|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984773|NCT00853723|O3|Outcome|PTH 20 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone (PTH) 1-34, 20 micrograms / day for 3 months
984774|NCT00853723|O2|Outcome|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 600 micrograms / day for 3 months
984775|NCT00853723|O1|Outcome|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis or low bone density will subcutaneously administer Parathyroid hormone related protein (PTHrP) 1-36, 400 micrograms / day for 3 months
984776|NCT00853723|E3|Reported Event|PTH 20 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer the FDA approved dose of PTH 20 micrograms daily for three months.
984777|NCT00853723|E2|Reported Event|PTHrP 600 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 600 micrograms daily for three months.
984778|NCT00853723|E1|Reported Event|PTHrP 400 mcg/Day|Post-menopausal women with osteoporosis will subcutaneously administer PTHrP 400 micrograms daily for three months.
984779|NCT00853658|B4|Baseline|Total|Total of all reporting groups
984780|NCT00853658|B3|Baseline|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
984781|NCT00853658|B2|Baseline|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
984782|NCT00853658|B1|Baseline|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
984783|NCT00853658|P3|Participant Flow|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
984784|NCT00853658|P2|Participant Flow|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
984785|NCT00853658|P1|Participant Flow|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
984786|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
984787|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
984788|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
984789|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
984790|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
984791|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
984792|NCT00853658|O3|Outcome|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
984793|NCT00853658|O2|Outcome|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
984794|NCT00853658|O1|Outcome|Combination Aliskiren / Enalapril|Aliskiren / Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg film-coated tablets and administered orally.
984795|NCT00853658|E3|Reported Event|Enalapril|Enalapril monotherapy -10 mg film-coated tablet and administered orally.
984796|NCT00853658|E2|Reported Event|Aliskiren|Aliskiren monotherapy - 150 mg titrated to 300 mg film-coated tablets and administered orally.
984797|NCT00853658|E1|Reported Event|Combination of Aliskiren and Enalapril|Aliskiren/Enalapril combination therapy-150 mg/10 mg titrated to 300 mg/ 10 mg
984798|NCT00853606|B1|Baseline|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
985118|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
984799|NCT00853606|P1|Participant Flow|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
984800|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
984801|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
984802|NCT00853606|O1|Outcome|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
984803|NCT00853606|E1|Reported Event|Avanafil|All subjects will initially be assigned to treatment with avanafil 100 mg. Subjects who are unable to tolerate treatment with the 100 mg dose may request a dose reduction to 50 mg. Study medication should be taken orally with water 30 minutes prior to the initiation of sexual activity.
984804|NCT00853593|B1|Baseline|Model 4396 LV Lead|Subjects underwent Model 4396 left ventricular lead implant attempt
984805|NCT00853593|P1|Participant Flow|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
984806|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration R-wave amplitude at 6 month.
984807|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration pacing impedance at 6 month.
984808|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with bipolar configuration threshold captured at 0.5ms at 6 month.
984809|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at implant.
984810|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode pacing impedance at 6 month.
984811|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5 ms at 6 month.
984812|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode R-wave amplitude at 6 month.
984813|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode pacing impedance at 6 month.
984814|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode threshold captured at 0.5ms at 6 month.
984815|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead and completed 1 month visit.
984816|NCT00853593|O1|Outcome|Model 4396 LV Lead|Model 4396 lead implant attempts.
984817|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
984818|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
984819|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
984820|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
984821|NCT00853593|O1|Outcome|Any Medtronic LV Lead (Attain Family Lead)|Subjects who underwent an implant attempt.
984822|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt.
984823|NCT00853593|O1|Outcome|Any Transvenous LV Lead|Subjects who underwent an implant attempt with successful CS cannulation.
984824|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
984825|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month.
984826|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects with tip electrode capture at 0.5ms at 1-month.
984827|NCT00853593|O1|Outcome|Model 4396 LV Lead|Subjects who underwent a Model 4396 left ventricular lead implant attempt
984828|NCT00853593|E1|Reported Event|Model 4396 LV Lead|Subjects successfully implanted with a Model 4396 LV lead.
984829|NCT00853567|B4|Baseline|Total|Total of all reporting groups
984830|NCT00853567|B3|Baseline|Placebo|Placebo treatment
984831|NCT00853567|B2|Baseline|50 mg Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
984832|NCT00853567|B1|Baseline|25 g Proellex|Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo
984833|NCT00853567|P1|Participant Flow|All Arms|Proellex: 25 mg or 50 mg or placebo oral daily dose
984834|NCT00853567|O3|Outcome|Placebo|"Placebo treatment~placebo: Placebo"
984835|NCT00853567|O2|Outcome|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
984836|NCT00853567|O1|Outcome|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
984837|NCT00853567|E3|Reported Event|Placebo|"Placebo treatment~placebo: Placebo"
984838|NCT00853567|E2|Reported Event|50 mg Proellex|"50 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
984839|NCT00853567|E1|Reported Event|25 g Proellex|"25 mg oral daily dose of Proellex~Proellex: 25 mg oral daily dose vs. 50 mg oral daily dose vs. placebo"
984840|NCT00853385|B6|Baseline|Total|Total of all reporting groups
984841|NCT00853385|B5|Baseline|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984842|NCT00853385|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985119|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
984843|NCT00853385|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984844|NCT00853385|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984845|NCT00853385|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984846|NCT00853385|P5|Participant Flow|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984847|NCT00853385|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984848|NCT00853385|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984849|NCT00853385|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984850|NCT00853385|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984851|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984852|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984853|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984854|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984855|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984856|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984857|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984858|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984859|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984860|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985077|NCT00853242|B6|Baseline|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985078|NCT00853242|B5|Baseline|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985079|NCT00853242|B4|Baseline|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
984861|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984862|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984863|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984864|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984865|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984866|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984867|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984868|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984869|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984870|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984871|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984872|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984873|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984874|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984875|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984876|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984877|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984878|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985080|NCT00853242|B3|Baseline|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985081|NCT00853242|B2|Baseline|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985082|NCT00853242|B1|Baseline|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
985083|NCT00853242|P7|Participant Flow|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
984879|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984880|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984881|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984882|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984883|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984884|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984885|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984886|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984887|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984888|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984889|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984890|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984891|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984892|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984893|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984894|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984895|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984896|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985084|NCT00853242|P6|Participant Flow|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985085|NCT00853242|P5|Participant Flow|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985086|NCT00853242|P4|Participant Flow|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985087|NCT00853242|P3|Participant Flow|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
984897|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984898|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984899|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984900|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984901|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984902|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984903|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984904|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984905|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984906|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984907|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984908|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984909|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984910|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984911|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984912|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984913|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984914|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985088|NCT00853242|P2|Participant Flow|Genz-644470 2.4 Grams Per Day (g/Day)|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985089|NCT00853242|P1|Participant Flow|Placebo|Placebo matched to Genz-644470 tablet orally three times a day (TID) with meals for 3 weeks.
985090|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985091|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
984915|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984916|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984917|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984918|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984919|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984920|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984921|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984922|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984923|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984924|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984925|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984926|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984927|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984928|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984929|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984930|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984931|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984932|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985092|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985093|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985094|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985095|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
984933|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984934|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984935|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984936|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984937|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984938|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984939|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984940|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984941|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984942|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984943|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984944|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984945|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984946|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984947|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984948|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984949|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984950|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985096|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
985097|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985098|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985099|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
984951|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984952|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984953|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984954|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984955|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984956|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984957|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984958|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984959|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984960|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984961|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984962|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984963|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984964|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984965|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984966|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984967|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984968|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985100|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985101|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985102|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985103|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
985332|NCT00853073|B3|Baseline|Total|Total of all reporting groups
984969|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984970|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984971|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984972|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984973|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984974|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984975|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984976|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984977|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984978|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984979|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984980|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984981|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984982|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984983|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984984|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984985|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984986|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985104|NCT00853242|O7|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985105|NCT00853242|O6|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985106|NCT00853242|O5|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985107|NCT00853242|O4|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
984987|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984988|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984989|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984990|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984991|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984992|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984993|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984994|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
984995|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984996|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984997|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984998|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
984999|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985000|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985001|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985002|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985003|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985004|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985108|NCT00853242|O3|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985109|NCT00853242|O2|Outcome|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985110|NCT00853242|O1|Outcome|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
985111|NCT00853242|O6|Outcome|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
990651|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
985005|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985006|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985007|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985008|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985009|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985010|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985011|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985012|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985013|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985014|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985015|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985016|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985017|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985018|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985019|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985020|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985021|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985022|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985112|NCT00853242|O5|Outcome|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985113|NCT00853242|O4|Outcome|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985114|NCT00853242|O3|Outcome|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985115|NCT00853242|O2|Outcome|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985023|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985024|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985025|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985026|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985027|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985028|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985029|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985030|NCT00853385|O5|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985031|NCT00853385|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985032|NCT00853385|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week, for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts from baseline, received CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants advanced to CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985033|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985034|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985035|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985036|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985037|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985038|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985039|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985040|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985041|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985042|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985043|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985044|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985045|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985046|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985047|NCT00853385|O4|Outcome|Adalimumab|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 12.
985048|NCT00853385|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985049|NCT00853385|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985050|NCT00853385|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985051|NCT00853385|E11|Reported Event|Adalimumab (Post Month 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 6 to Month 12.
985052|NCT00853385|E10|Reported Event|CP-690,550 10 mg (Post Month 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
985053|NCT00853385|E9|Reported Event|CP-690,550 5 mg (Post Month 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 6 to Month 12.
985054|NCT00853385|E8|Reported Event|Adalimumab (Month 3 to 6)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily from Month 3 to Month 6.
985055|NCT00853385|E7|Reported Event|Placebo (Month 3 to 6)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985056|NCT00853385|E6|Reported Event|CP-690,550 10 mg (Month 3 to 6)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
985057|NCT00853385|E5|Reported Event|CP-690,550 5 mg (Month 3 to 6)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week from Month 3 to Month 6.
985058|NCT00853385|E4|Reported Event|Adalimumab (Up To Month 3)|Adalimumab 40 mg injection subcutaneously once every other week along with placebo matched to CP-690,550 5 mg tablet orally twice daily up to Month 3.
985059|NCT00853385|E3|Reported Event|Placebo (Up To Month 3)|Placebo matched to CP-690,550 tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week for 3 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 12.
985060|NCT00853385|E2|Reported Event|CP-690,550 10 mg (Up To Month 3)|CP-690,550 10 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
985061|NCT00853385|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|CP-690,550 5 mg tablet orally twice daily along with placebo matched to adalimumab 40 mg injection subcutaneously once every other week up to Month 3.
985062|NCT00853333|B4|Baseline|Total|Total of all reporting groups
985063|NCT00853333|B3|Baseline|Propofol|
985064|NCT00853333|B2|Baseline|Midazolam|
985065|NCT00853333|B1|Baseline|Dexmedetomidine|
985066|NCT00853333|P3|Participant Flow|Propofol|Sedation Arm 3, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
985067|NCT00853333|P2|Participant Flow|Midazolam|Sedation Arm 2, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
985068|NCT00853333|P1|Participant Flow|Dexmedetomidine|Sedation Arm 1, Dose adjusted to Sedation Self-rating of 50% on Sedation Scale.
985069|NCT00853333|O3|Outcome|Propofol|
985070|NCT00853333|O2|Outcome|Midazolam|
985071|NCT00853333|O1|Outcome|Dexmedetomidine|
985072|NCT00853333|E3|Reported Event|Propofol|
985073|NCT00853333|E2|Reported Event|Midazolam|
985074|NCT00853333|E1|Reported Event|Dexmedetomidine|
985075|NCT00853242|B8|Baseline|Total|Total of all reporting groups
985076|NCT00853242|B7|Baseline|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
990652|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
985121|NCT00853242|E7|Reported Event|Sevelamer Carbonate 7.2 g/Day|Sevelamer Carbonate 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985122|NCT00853242|E6|Reported Event|Sevelamer Carbonate 4.8 g/Day|Sevelamer Carbonate 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985123|NCT00853242|E5|Reported Event|Sevelamer Carbonate 2.4 g/Day|Sevelamer Carbonate 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985124|NCT00853242|E4|Reported Event|Genz-644470 7.2 g/Day|Genz-644470 7.2 g/day tablets dosed orally TID with meals for 3 weeks.
985125|NCT00853242|E3|Reported Event|Genz-644470 4.8 g/Day|Genz-644470 4.8 g/day tablets dosed orally TID with meals for 3 weeks.
985126|NCT00853242|E2|Reported Event|Genz-644470 2.4 g/Day|Genz-644470 2.4 g/day tablets dosed orally TID with meals for 3 weeks.
985127|NCT00853242|E1|Reported Event|Placebo|Placebo matched to Genz-644470 tablet orally TID with meals for 3 weeks.
985128|NCT00853229|B3|Baseline|Total|Total of all reporting groups
985129|NCT00853229|B2|Baseline|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985130|NCT00853229|B1|Baseline|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985131|NCT00853229|P2|Participant Flow|Placebo First 4 Weeks|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985132|NCT00853229|P1|Participant Flow|Pregabalin First 4 Weeks|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985133|NCT00853229|O2|Outcome|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985134|NCT00853229|O1|Outcome|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985135|NCT00853229|E2|Reported Event|Placebo/Pregabalin|"placebo and pregabalin given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985136|NCT00853229|E1|Reported Event|Pregabalin/Placebo|"pregabalin and placebo given using a cross-over design~pregabalin: pregabalin 150mg twice daily for 4 weeks"
985137|NCT00853151|B5|Baseline|Total|Total of all reporting groups
985138|NCT00853151|B4|Baseline|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985139|NCT00853151|B3|Baseline|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985140|NCT00853151|B2|Baseline|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985141|NCT00853151|B1|Baseline|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985142|NCT00853151|P4|Participant Flow|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985143|NCT00853151|P3|Participant Flow|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985144|NCT00853151|P2|Participant Flow|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985145|NCT00853151|P1|Participant Flow|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985146|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985147|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985148|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985149|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985150|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985151|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985152|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985153|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985154|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985155|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985156|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985157|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985158|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985159|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985160|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985161|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985162|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985163|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985164|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985165|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985166|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985167|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985168|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985169|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985170|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985171|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985172|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985173|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985174|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985175|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985176|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985177|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985178|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985179|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985180|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985181|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985182|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985183|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985184|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985185|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985186|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985187|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985188|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985189|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985190|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985191|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985192|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985193|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985194|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985195|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985196|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985197|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985198|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985199|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985200|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
985201|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985202|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
990653|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
985203|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985204|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985205|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985206|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985207|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985208|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985209|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985210|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985211|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985212|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks TT223
985213|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985214|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985215|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985216|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985217|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985218|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985219|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985220|NCT00853151|O2|Outcome|LY2428757 Plus TT223 3 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985221|NCT00853151|O1|Outcome|LY2428757 Plus TT223 2 mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985222|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985223|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985224|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985225|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985226|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985227|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985228|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985229|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985230|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985231|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985232|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985233|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985234|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985235|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985236|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985237|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985238|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985239|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985240|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985241|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985242|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985490|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985243|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985244|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985245|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985246|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985247|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985248|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985249|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985250|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985251|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985252|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985253|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985254|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985255|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985256|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985257|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985258|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985259|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985260|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985261|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985262|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985263|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985264|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985265|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985266|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985267|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985268|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985269|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985270|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985271|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985272|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985273|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985274|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985275|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985276|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985277|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985278|NCT00853151|O4|Outcome|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985279|NCT00853151|O3|Outcome|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985280|NCT00853151|O2|Outcome|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985281|NCT00853151|O1|Outcome|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985282|NCT00853151|E4|Reported Event|LY Placebo Plus TT223 Placebo|Weekly LY2428757 placebo subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985283|NCT00853151|E3|Reported Event|LY2428757 Plus TT223 Placebo|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 placebo subcutaneous injection daily for 4 weeks
985284|NCT00853151|E2|Reported Event|LY2428757 Plus TT223 2mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 2 mg subcutaneous injection daily for 4 weeks
985285|NCT00853151|E1|Reported Event|LY2428757 Plus TT223 3mg|Weekly LY2428757 14 mg subcutaneous injection for 5 weeks plus TT223 3 mg subcutaneous injection daily for 4 weeks
985286|NCT00853099|B4|Baseline|Total|Total of all reporting groups
985287|NCT00853099|B3|Baseline|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985288|NCT00853099|B2|Baseline|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985289|NCT00853099|B1|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985290|NCT00853099|P4|Participant Flow|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
985291|NCT00853099|P3|Participant Flow|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
985292|NCT00853099|P2|Participant Flow|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
985293|NCT00853099|P1|Participant Flow|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
985294|NCT00853099|O1|Outcome|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
985295|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985296|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985297|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985298|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985299|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985300|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985301|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
990654|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
985417|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
985302|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985303|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985304|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985305|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985306|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985307|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985308|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985309|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985310|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985311|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985312|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985313|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985314|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985315|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985356|NCT00852995|P3|Participant Flow|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985316|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985317|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985318|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985319|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985320|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985321|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985322|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985323|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985324|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985325|NCT00853099|O3|Outcome|Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985326|NCT00853099|O2|Outcome|Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985327|NCT00853099|O1|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week. Participants who completed the 52-week double-blind period received open-label adalimumab 40 mg every other week, with the possibility to escalate to 80 mg every other week, until drug approval.
985328|NCT00853099|E4|Reported Event|All Adalimumab|All participants who received at least one dose of adalimumab during the study (adalimumab treatment groups in the double-blind phase, and participants randomized to placebo who received adalimumab in the rescue phase or open-label phase).
985329|NCT00853099|E3|Reported Event|Double-blind Adalimumab 160 mg/80 mg|Participants received adalimumab 160 mg on Day 1, 80 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
985330|NCT00853099|E2|Reported Event|Double-blind Adalimumab 80 mg/40 mg|Participants received adalimumab 80 mg on Day 1, 40 mg at Week 2 and 40 mg every other week from Week 4 to Week 50, via subcutaneous injection. From Week 8, participants with an inadequate response could switch to rescue therapy, where they received adalimumab 40 mg every other week.
985331|NCT00853099|E1|Reported Event|Double-blind Placebo|Participants received placebo subcutaneous injections every 2 weeks for 52 weeks. From Week 8, participants with an inadequate response could switch to rescue therapy, where they initially received adalimumab 160 mg, 80 mg 2 weeks later, and then 40 mg every other week.
985333|NCT00853073|B2|Baseline|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
985334|NCT00853073|B1|Baseline|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
985335|NCT00853073|P2|Participant Flow|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
985336|NCT00853073|P1|Participant Flow|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
985337|NCT00853073|O2|Outcome|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
985338|NCT00853073|O1|Outcome|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
985339|NCT00853073|E2|Reported Event|Treatment B (Balanced Salt Solution)|"patients randomized to treatment B are given 0.04cc of balanced salt solution injected in identical fashion either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~balanced salt solution: 0.04 cc of balanced salt solution injected to the bleb following bleb needling procedure"
985340|NCT00853073|E1|Reported Event|Treatment A (Bevacizumab)|"subjects will receive 1.0mg (0.04cc of 25 mg/ml) subconjunctival bevacizumab either temporal or nasal to the bleb following bleb needling procedure in addition to 0.1 cc mitomycin C.~bevacizumab: 1.0mg (0.04 cc of 25 mg/ml subconjunctival bevacizumab following bleb needling procedure"
985341|NCT00853021|B1|Baseline|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
985342|NCT00853021|P1|Participant Flow|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
985343|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
985344|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
985345|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
985346|NCT00853021|O1|Outcome|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
985347|NCT00853021|E1|Reported Event|Bevacizumab and Aldesleukin|"aldesleukin: SQ Aldesleukin (Days 1-5) Monday through Friday for six weeks followed by a two-week break.~bevacizumab: Bevacizumab will be administered on day -14, then on day 1 and every 2 weeks thereafter (days 1, 15, 29, and 42) in a continuous manner."
985348|NCT00852995|B6|Baseline|Total|Total of all reporting groups
985349|NCT00852995|B5|Baseline|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985350|NCT00852995|B4|Baseline|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985351|NCT00852995|B3|Baseline|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985352|NCT00852995|B2|Baseline|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985353|NCT00852995|B1|Baseline|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985354|NCT00852995|P5|Participant Flow|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985355|NCT00852995|P4|Participant Flow|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985484|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
990655|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
985357|NCT00852995|P2|Participant Flow|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985358|NCT00852995|P1|Participant Flow|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985359|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985360|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985361|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985362|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985363|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985364|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985365|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985366|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985367|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985368|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985369|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985370|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985371|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985372|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985373|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985374|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985375|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985376|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985377|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985378|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985379|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985380|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985381|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985485|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985382|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985383|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985384|NCT00852995|O5|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985385|NCT00852995|O4|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985386|NCT00852995|O3|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985387|NCT00852995|O2|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985388|NCT00852995|O1|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985389|NCT00852995|O5|Outcome|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985390|NCT00852995|O4|Outcome|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985391|NCT00852995|O3|Outcome|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985392|NCT00852995|O2|Outcome|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985393|NCT00852995|O1|Outcome|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985394|NCT00852995|E5|Reported Event|C - High Q7D|"High dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985395|NCT00852995|E4|Reported Event|D - High Q14D|"High dose HP802-247, applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985396|NCT00852995|E3|Reported Event|A - Low Q7D|"Low dose HP802-247, applied at each visit~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985397|NCT00852995|E2|Reported Event|B - Low Q14D|"Low dose HP802-247 applied at Visits 1, 3, 5, 7, 9, 11 and Placebo at Visits 2, 4, 6, 8, 10, and 12~HP802-247: One dose of HP802-247 consists of 260 microliters (uL) containing keratinocytes and fibroblasts totaling 0.5 x 10-6 power or 5.0 x 10-6 power cells per mL, plus fibrin."
985398|NCT00852995|E1|Reported Event|E - HP802-247 Vehicle|"Placebo (Vehicle), applied at each visit~Placebo (Vehicle): Placebo (Vehicle) consisting of:~Component 1 – acellular fibrinogen solution; Component 2 – acellular thrombin solution"
985399|NCT00852969|B3|Baseline|Total|Total of all reporting groups
985400|NCT00852969|B2|Baseline|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
985401|NCT00852969|B1|Baseline|Niacin|Niacin : 1000 mg tablets once per day
985402|NCT00852969|P2|Participant Flow|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
985403|NCT00852969|P1|Participant Flow|Niacin|Niacin : 1000 mg tablets once per day
985404|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
985405|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
985406|NCT00852969|O2|Outcome|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
985407|NCT00852969|O1|Outcome|Niacin|Niacin : 1000 mg tablets once per day
985408|NCT00852969|E2|Reported Event|Placebo|Active Placebo : 100 mg Niacin tablets once per day. Placebo tablets had same appearance
985409|NCT00852969|E1|Reported Event|Niacin|Niacin : 1000 mg tablets once per day
985410|NCT00852930|B4|Baseline|Total|Total of all reporting groups
985411|NCT00852930|B3|Baseline|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
985412|NCT00852930|B2|Baseline|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
985413|NCT00852930|B1|Baseline|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
985414|NCT00852930|P3|Participant Flow|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
985415|NCT00852930|P2|Participant Flow|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
985416|NCT00852930|P1|Participant Flow|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
985418|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage (mld)~manual lymphatic drainage: therapist administered massage therapy"
985419|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
985420|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
985421|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
985422|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
985423|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
985424|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
985425|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
985426|NCT00852930|O3|Outcome|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment"
985427|NCT00852930|O2|Outcome|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy"
985428|NCT00852930|O1|Outcome|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser"
985429|NCT00852930|E3|Reported Event|Laser and Mld Combined|"therapist administered laser and mld~Low Level Laser Therapy with Manual Lymphatic Drainage: therapist will give both mld and laser treatment~No adverse events during the study."
985430|NCT00852930|E2|Reported Event|Mld Alone|"therapist administered manual lymphatic drainage~manual lymphatic drainage: therapist administered massage therapy~No adverse events during the study."
985431|NCT00852930|E1|Reported Event|Laser Therapy Alone|"therapist administered laser treatment~laser: therapist administered laser~No adverse events during the study."
985432|NCT00852917|B5|Baseline|Total|Total of all reporting groups
985433|NCT00852917|B4|Baseline|4: Placebo|
985434|NCT00852917|B3|Baseline|3: Tramadol Once A Day 300mg|
985435|NCT00852917|B2|Baseline|2: Tramadol Once A Day 200mg|
985436|NCT00852917|B1|Baseline|1: Tramadol Once A Day 100mg|
985437|NCT00852917|P4|Participant Flow|4: Placebo|
985438|NCT00852917|P3|Participant Flow|3: Tramadol Once A Day 300mg|
985439|NCT00852917|P2|Participant Flow|2: Tramadol Once A Day 200mg|
985440|NCT00852917|P1|Participant Flow|1: Tramadol Once A Day 100mg|
985441|NCT00852917|O4|Outcome|4: Placebo|
985442|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985443|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985444|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985445|NCT00852917|O4|Outcome|4: Placebo|
985446|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985447|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985448|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985449|NCT00852917|O4|Outcome|4: Placebo|
985450|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985451|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985452|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985453|NCT00852917|O4|Outcome|4: Placebo|
985454|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985455|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985456|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985457|NCT00852917|O4|Outcome|4: Placebo|
985458|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985459|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985460|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985461|NCT00852917|O4|Outcome|4: Placebo|
985462|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985463|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985464|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985465|NCT00852917|O4|Outcome|4: Placebo|
985466|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985467|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985468|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985469|NCT00852917|O4|Outcome|4: Placebo|
985470|NCT00852917|O3|Outcome|3: Tramadol Once A Day 300mg|
985471|NCT00852917|O2|Outcome|2: Tramadol Once A Day 200mg|
985472|NCT00852917|O1|Outcome|1: Tramadol Once A Day 100mg|
985473|NCT00852917|E4|Reported Event|4: Placebo|
985474|NCT00852917|E3|Reported Event|3: Tramadol Once A Day 300mg|
985475|NCT00852917|E2|Reported Event|2: Tramadol Once A Day 200mg|
985476|NCT00852917|E1|Reported Event|1: Tramadol Once A Day 100mg|
985477|NCT00852761|B3|Baseline|Total|Total of all reporting groups
985478|NCT00852761|B2|Baseline|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
985479|NCT00852761|B1|Baseline|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
985480|NCT00852761|P2|Participant Flow|Clobex Lotion|Clobex (Clobetasol propionate 0.05 percent) lotion. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
985481|NCT00852761|P1|Participant Flow|Olux-E Foam|Olux-E (Clobetasol propionate 0.05 percent) foam. Administered twice daily to the elbow and/or knees, morning and evening, after washing with a mild cleanser.
985482|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985483|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985491|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985492|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985494|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985495|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985496|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985497|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985498|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985499|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985500|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985501|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985502|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985503|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985504|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985505|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985506|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985507|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985508|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985509|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985510|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985511|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985512|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985513|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985514|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985515|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985516|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985517|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985518|NCT00852761|O2|Outcome|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985519|NCT00852761|O1|Outcome|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985520|NCT00852761|E2|Reported Event|Clobex Lotion|Clobex (clobetasol propionate 0.05%) lotion.
985521|NCT00852761|E1|Reported Event|Olux-E Foam|Olux-E (clobetasol propionate 0.05%) foam
985522|NCT00852631|B1|Baseline|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
985523|NCT00852631|P1|Participant Flow|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
985524|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
985525|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
985526|NCT00852631|O1|Outcome|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
985527|NCT00852631|E1|Reported Event|Seroquel XR|Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days.
985528|NCT00852592|B3|Baseline|Total|Total of all reporting groups
985529|NCT00852592|B2|Baseline|Inactive Comparator|"inactive light unit~Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily"
985530|NCT00852592|B1|Baseline|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
985531|NCT00852592|P2|Participant Flow|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
985532|NCT00852592|P1|Participant Flow|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
985533|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
985534|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
985535|NCT00852592|O2|Outcome|Inactive Light Unit|Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
985536|NCT00852592|O1|Outcome|Active Light Unit|active light therapy unit: dosage - 15-60minutes NOON-2PM daily
985537|NCT00852592|E2|Reported Event|Inactive Comparator|inactive light unit Inactive light therapy unit: dosage: 15-60minutes NOON-2PM daily
985538|NCT00852592|E1|Reported Event|Active Comparator|"active light unit~active light therapy unit: dosage - 15-60minutes NOON-2PM daily"
985539|NCT00852540|B3|Baseline|Total|Total of all reporting groups
985540|NCT00852540|B2|Baseline|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985541|NCT00852540|B1|Baseline|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985589|NCT00852397|P3|Participant Flow|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985593|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985638|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985542|NCT00852540|P2|Participant Flow|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985543|NCT00852540|P1|Participant Flow|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985544|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985545|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985546|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (&gt;=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were &lt;5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985547|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985548|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985549|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985550|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985551|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985552|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985553|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985554|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985555|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985556|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985557|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985558|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985559|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985560|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985561|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985562|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985590|NCT00852397|P2|Participant Flow|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985591|NCT00852397|P1|Participant Flow|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985592|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985563|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985564|NCT00852540|O2|Outcome|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985565|NCT00852540|O1|Outcome|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985566|NCT00852540|E2|Reported Event|Linezolid Plus Placebo Ointment|Linezolid was to be dosed, depending on participant age, either BID or TID for 10 days. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg tablets for 10 days. Pediatric participants who were 5-11 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg BID for 10 days. Pediatric participants who were <5 years of age were dosed with a 100 mg/5 ml oral suspension at a dose of 10 mg/kg TID for 10 days. Placebo ointment was administered topically BID for 5 days.
985567|NCT00852540|E1|Reported Event|Retapamulin Ointment, 1% (Weight/Weight) Plus Oral Placebo|Retapamulin ointment was administered topically twice daily (BID) for 5 days. The ointment formulation was to be applied to the infected lesion(s) at a dose of approximately 10 milligrams (mg) per centimeter squared (cm^2). Placebo was to be dosed, depending on participant age, either BID or three times a day (TID) for 10 days. Placebo oral suspension and oral tablet were formulated to appear identical to the linezolid formulations. Adolescent and adult participants (>=12 years of age) were dosed BID with 600 mg placebo tablets, pediatric participants 5 to 11 years of age were dosed with oral suspension at 0.5 milliliters (ml)/kilogram (kg) BID, and pediatric participants less than 5 years of age were dosed with oral suspension at 0.5 ml/kg TID.
985568|NCT00852527|B1|Baseline|OEF/OIF Veterans|Operation Enduring Freedom /Operation Iraqi Freedom (OEF/OIF) Veterans seeking care at one of three VA Polytrauma Network Sites (PNS) who screen positive or negative for mild traumatic brain injury.
985569|NCT00852527|P2|Participant Flow|Negative Mild TBI|Participants who screened negative on the TBI Clinical Reminder Screen
985570|NCT00852527|P1|Participant Flow|Positive Mild TBI|Participants who screened positive on the TBI Clinical Reminder Screen
985571|NCT00852527|O2|Outcome|Veterans Assessed With the Structured TBI Diagnostic Interview|
985572|NCT00852527|O1|Outcome|Veterans Assessed With the Comprehensive TBI Evaluation|
985573|NCT00852527|E1|Reported Event|OEF/OIF Veterans|No adverse events.
985574|NCT00852475|B3|Baseline|Total|Total of all reporting groups
985575|NCT00852475|B2|Baseline|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
985576|NCT00852475|B1|Baseline|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
985577|NCT00852475|P2|Participant Flow|PUFA|"Assignment to polyunsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
985578|NCT00852475|P1|Participant Flow|MUFA|"Assignment to monounsaturated enriched diet (in the form of enriched muffins or oils) with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE! diet and exercise program"
985579|NCT00852475|O2|Outcome|PUFA Arm|Assessment of FMD after 6 months of PUFA enrichment
985580|NCT00852475|O1|Outcome|MUFA Arm|Assessment of FMD after six months of MUFA enrichment
985581|NCT00852475|O2|Outcome|PUFA|"Assignment to polyunsaturated enriched diet with exercise. This represents the PUFA MOVE! program~PUFA MOVE! (Polyunsaturated fatty acid enriched diet): PUFA MOVE! diet and exercise program"
985582|NCT00852475|O1|Outcome|MUFA|"Assignment to monounsaturated enriched diet with exercise. This represents the MUFA MOVE! program~MUFA MOVE! (Monounsaturated fatty enriched diet): MUFA MOVE!diet and exercise program"
985583|NCT00852475|E2|Reported Event|PUFA|subjects received a diet enriched in PUFA
985584|NCT00852475|E1|Reported Event|MUFA|subjects received a diet enriched in MUFA
985585|NCT00852397|B4|Baseline|Total|Total of all reporting groups
985586|NCT00852397|B3|Baseline|Apixaban 5.0 mg BID|"Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
985587|NCT00852397|B2|Baseline|Apixaban 2.5 mg BID|"2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
985588|NCT00852397|B1|Baseline|Placebo|"Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.~Number of participants in baseline characteristics means randomized participants."
987308|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
985594|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985595|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985596|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985597|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985598|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985599|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985600|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985601|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985602|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985603|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985604|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985605|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985606|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985607|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985608|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985609|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985610|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985611|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985612|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985613|NCT00852397|O3|Outcome|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985614|NCT00852397|O2|Outcome|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985615|NCT00852397|O1|Outcome|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985616|NCT00852397|E3|Reported Event|Apixaban 5.0 mg BID|Apixaban 5.0 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985617|NCT00852397|E2|Reported Event|Apixaban 2.5 mg BID|Apixaban 2.5 mg was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985618|NCT00852397|E1|Reported Event|Placebo|Placebo was administered twice a day in addition to the standard therapy (aspirin with or without clopidogrel or ticlopidine) for 24 weeks.
985619|NCT00852137|B3|Baseline|Total|Total of all reporting groups
985620|NCT00852137|B2|Baseline|Vehicle|Vehicle gel once daily for 2 consecutive days
985621|NCT00852137|B1|Baseline|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985622|NCT00852137|P2|Participant Flow|Vehicle|Vehicle gel once daily for 2 consecutive days
985623|NCT00852137|P1|Participant Flow|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985624|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985625|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985626|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985627|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985628|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985629|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985630|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985631|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985632|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985633|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985634|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985635|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985636|NCT00852137|O2|Outcome|Vehicle|Vehicle gel once daily for 2 consecutive days
985637|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
1026976|NCT00753623|B3|Baseline|Total|Total of all reporting groups
985639|NCT00852137|O1|Outcome|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985640|NCT00852137|E2|Reported Event|Vehicle|Vehicle gel once daily for 2 consecutive days
985641|NCT00852137|E1|Reported Event|PEP005 Gel, 0.05%|PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days
985642|NCT00852124|B3|Baseline|Total|Total of all reporting groups
985643|NCT00852124|B2|Baseline|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
985644|NCT00852124|B1|Baseline|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
985645|NCT00852124|P2|Participant Flow|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
985646|NCT00852124|P1|Participant Flow|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
985647|NCT00852124|O1|Outcome|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
985648|NCT00852124|E2|Reported Event|VSL#3|"Packets of VSL#3 (powder containing 8 bacteria believed to be beneficial)taken 2 x daily in food or a cool beverage.~VSL#3 : VSL#3 2 times daily"
985649|NCT00852124|E1|Reported Event|Placebo|"Packets similar to VSL#3 taken 2 X daily but not containing active bacteria~VSL#3 or placebo : 1 packet 2 x daily of placebo"
985650|NCT00851903|B1|Baseline|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985651|NCT00851903|P1|Participant Flow|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 < Fasting Plasma Glucose (FPG) ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985652|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985653|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985654|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985655|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985656|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985673|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
990656|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
985843|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985657|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985658|NCT00851903|O1|Outcome|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985659|NCT00851903|E1|Reported Event|Combination Insulin Glargine and Sitagliptin|"Insulin glargine administered once a day, in the evening, at dinner or at bedtime. Starting dose: - last dose administered in the core study for patients previously treated with insulin glargine, - 0.2 U/Kg of body weight for patients previously treated with sitagliptin. Monitoring of blood glucose and titration: all patients, irrespective of their previous treatment group in the core study were empowered to adjust their insulin doses, under strict investigator's supervision. The goal was to achieve through a force titration 70 <FPG ≤ 100 mg/dL (3.9 <FPG ≤ 5.5 mmol/L).~Sitagliptin: stable dose of 100 mg once a day administered with or without food."
985660|NCT00851890|B5|Baseline|Total|Total of all reporting groups
985661|NCT00851890|B4|Baseline|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985662|NCT00851890|B3|Baseline|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985663|NCT00851890|B2|Baseline|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985664|NCT00851890|B1|Baseline|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985665|NCT00851890|P4|Participant Flow|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985666|NCT00851890|P3|Participant Flow|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985667|NCT00851890|P2|Participant Flow|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985668|NCT00851890|P1|Participant Flow|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985669|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985670|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985671|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985672|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985729|NCT00851799|P2|Participant Flow|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985674|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985675|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985676|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985677|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985678|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985679|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985680|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985681|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985682|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985683|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985684|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985685|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985686|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985687|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985688|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985689|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985690|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985691|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
987309|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
985692|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985693|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985694|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985695|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985696|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985697|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985698|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985699|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985700|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985701|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985702|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985703|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985704|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985705|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985706|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985707|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985708|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985709|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
987310|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
985710|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985711|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985712|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985713|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985714|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985715|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985716|NCT00851890|O4|Outcome|Placebo + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985717|NCT00851890|O3|Outcome|ABT-333 (1200 mg) Once Daily (QD) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 QD with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985718|NCT00851890|O2|Outcome|ABT-333 (600 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985719|NCT00851890|O1|Outcome|ABT-333 (300 mg) Twice Daily (BID) + pegIFN/RBV|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and RBV was dosed 1000 or 1200 mg daily divided twice a day.
985720|NCT00851890|E4|Reported Event|Placebo + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naïve participants received matching placebo once daily (QD) or twice daily (BID) for 2 days followed by placebo QD or BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
985721|NCT00851890|E3|Reported Event|ABT-333 (1200 mg) Once Daily (QD) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 1200 mg ABT-333 QD for 2 days followed by 1200 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
985722|NCT00851890|E2|Reported Event|ABT-333 (600 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 600 mg ABT-333 BID for 2 days followed by 600 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
985723|NCT00851890|E1|Reported Event|ABT-333 (300 mg) Twice Daily (BID) + (pegIFN/RBV)|Hepatitis C virus (HCV) positive, treatment-naive participants received 300 mg ABT-333 BID for 2 days followed by 300 mg ABT-333 BID with pegylated interferon/ribavirin (pegIFN/RBV) for 26 days. Pegylated interferon was administered at 180 μg subcutaneously once a week and the RBV was dosed 1000 or 1200 mg daily divided twice a day.
985724|NCT00851799|B4|Baseline|Total|Total of all reporting groups
985725|NCT00851799|B3|Baseline|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985726|NCT00851799|B2|Baseline|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985727|NCT00851799|B1|Baseline|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985728|NCT00851799|P3|Participant Flow|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985842|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985730|NCT00851799|P1|Participant Flow|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985731|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985732|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985733|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985734|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985735|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985736|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985737|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985738|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985739|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985740|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985741|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985742|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985743|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985744|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985745|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985746|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985747|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985748|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985749|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985750|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985878|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985751|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985752|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985753|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985754|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985755|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985756|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985757|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985758|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985759|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985760|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985761|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985762|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985763|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985764|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985765|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985766|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985767|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985768|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985769|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985770|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985771|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985912|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985772|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985773|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985774|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985775|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985776|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985777|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985778|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985779|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985780|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985781|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985782|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985783|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985784|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985785|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985786|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985787|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985788|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985789|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985790|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985791|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985792|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
986044|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986045|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
985793|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985794|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985795|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985796|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985797|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985798|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985799|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985800|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985801|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985802|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985803|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985804|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985805|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985806|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985807|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985808|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985809|NCT00851799|O3|Outcome|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985810|NCT00851799|O2|Outcome|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
985811|NCT00851799|O1|Outcome|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985812|NCT00851799|E3|Reported Event|Cohort C: DRV/RTV + FTC/TDF|"DRV/RTV + FTC/TDF~FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
985813|NCT00851799|E2|Reported Event|Cohort B: RAL + FTC/TDF|"RAL + FTC/TDF~FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
986046|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986047|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
985814|NCT00851799|E1|Reported Event|Cohort A: ATV/RTV + FTC/TDF|"ATV/RTV + FTC/TDF~Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
985815|NCT00851786|B3|Baseline|Total|Total of all reporting groups
985816|NCT00851786|B2|Baseline|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
985817|NCT00851786|B1|Baseline|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
985818|NCT00851786|P2|Participant Flow|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
985819|NCT00851786|P1|Participant Flow|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
985820|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
985821|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
985822|NCT00851786|O2|Outcome|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
985823|NCT00851786|O1|Outcome|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
985824|NCT00851786|E2|Reported Event|Placebo|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-<349 cells/uL vs. >=350 cells/uL), will be given one dose of placebo at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination afer which a safety assessment will be conducted
985825|NCT00851786|E1|Reported Event|ZOSTAVAX|Participants with CD4 cell counts of 200 cells/uL or greater in Stage 1 and 2, stratified by CD4 cell counts (200-349 cells/uL vs. >=350 cells/uL), will be given one dose of ZOSTAVAX (Zoster Vaccine Live) at Day 0 and Week 6 and will be followed for at least 42 days after each vaccination after which a safety assessment will be conducted.
985826|NCT00851721|B3|Baseline|Total|Total of all reporting groups
985827|NCT00851721|B2|Baseline|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985828|NCT00851721|B1|Baseline|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
985829|NCT00851721|P2|Participant Flow|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985830|NCT00851721|P1|Participant Flow|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
985831|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985832|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985833|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985834|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985835|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985836|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985837|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985838|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985839|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985840|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985841|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985844|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985845|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985846|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985847|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985848|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985849|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985850|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985851|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985852|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985853|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985854|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985855|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985856|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985857|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985858|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985859|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985860|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985861|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985862|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985863|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985864|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985865|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985866|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985867|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985868|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985869|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985870|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985871|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985872|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985873|NCT00851721|O2|Outcome|Prophylaxis|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985874|NCT00851721|O1|Outcome|On-demand|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985875|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985876|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985877|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985879|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985880|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985881|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985882|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985883|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985884|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985885|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985886|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985887|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985888|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985889|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985890|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985891|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985892|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985893|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985894|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985895|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985896|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985897|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985898|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985899|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985900|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985901|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985902|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985903|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985904|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985905|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985906|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician
985907|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician~Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
985908|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985909|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985910|NCT00851721|O1|Outcome|On-demand Arm Versus Prophylaxis Arm|"On-demand arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : FEIBA NF dose and dosing interval as prescribed by the treating physician~Prophylaxis arm: Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period"
985911|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985913|NCT00851721|O2|Outcome|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month prophylactic period
985914|NCT00851721|O1|Outcome|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated): FEIBA NF dose and dosing interval as prescribed by the treating physician
985915|NCT00851721|E2|Reported Event|Prophylaxis Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : 85 ± 15 U/kg of FEIBA NF every other day during the 12-month ± 14 days prophylactic period
985916|NCT00851721|E1|Reported Event|On-demand Arm|Factor VIII Inhibitor Bypassing Activity (nanofiltered, vapor heat-treated) : Standard FEIBA NF dose and dosing interval as prescribed by the treating physician
985917|NCT00851682|B3|Baseline|Total|Total of all reporting groups
985918|NCT00851682|B2|Baseline|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985919|NCT00851682|B1|Baseline|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985920|NCT00851682|P2|Participant Flow|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985921|NCT00851682|P1|Participant Flow|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985922|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985923|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985924|NCT00851682|O2|Outcome|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985925|NCT00851682|O1|Outcome|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985926|NCT00851682|E2|Reported Event|Brachytherapy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985927|NCT00851682|E1|Reported Event|Radical Prostatectomy Patients|"Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.~MRI scan: Each patient will undergo one, contrast-enhanced MRI scan prior to his planned, standard of care procedure, either radical prostatectomy or brachytherapy, depending on the study arm. Patients will be randomized to be imaged with either a phased array body coil or an endorectal coil."
985928|NCT00851643|B7|Baseline|Total|Total of all reporting groups
985929|NCT00851643|B6|Baseline|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985930|NCT00851643|B5|Baseline|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985931|NCT00851643|B4|Baseline|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985932|NCT00851643|B3|Baseline|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
986048|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986140|NCT00850603|E4|Reported Event|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
1028004|NCT00750191|B3|Baseline|Total|Total of all reporting groups
985933|NCT00851643|B2|Baseline|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate(AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985934|NCT00851643|B1|Baseline|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- Controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985935|NCT00851643|P6|Participant Flow|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 120 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985936|NCT00851643|P5|Participant Flow|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 60 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985937|NCT00851643|P4|Participant Flow|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase B. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985938|NCT00851643|P3|Participant Flow|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP Vaccine Adjuvanted With 281 mcg AAHS and 30 mcg IMX. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985939|NCT00851643|P2|Participant Flow|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™ (IMX). A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985940|NCT00851643|P1|Participant Flow|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)- controls from Phase A. A 0.5-mL intramuscular injection was administered at Day 1, Month 2 and Month 6.
985941|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
985942|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
985943|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
985944|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
985945|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
985946|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
985947|NCT00851643|O3|Outcome|Octavalent HPV With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 120 mcg ISCOMATRIX™ (IMX)
985948|NCT00851643|O2|Outcome|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 60 mcg ISCOMATRIX™(IMX)
985949|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase B Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase B
985950|NCT00851643|O3|Outcome|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 30 mcg ISCOMATRIX™ (IMX)
985951|NCT00851643|O2|Outcome|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 Virus-Like Particle (VLP) Vaccine Adjuvanted With 281 mcg Amorphous Aluminum Hydroxyphosphate Sulfate (AAHS) and 15 mcg ISCOMATRIX™(IMX)
985952|NCT00851643|O1|Outcome|qHPV (GARDASIL™) - Phase A Control|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) for Phase A
985953|NCT00851643|E5|Reported Event|Octavalent With 120 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 120 mcg IMX.
985954|NCT00851643|E4|Reported Event|Octavalent HPV With 60 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 60 mcg IMX.
985955|NCT00851643|E3|Reported Event|Octavalent HPV With 30 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 30 mcg IMX.
985956|NCT00851643|E2|Reported Event|Octavalent HPV With 15 mcg IMX / AAHS|Octavalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18, 31, 45, 52, and 58) L1 VLP vaccine adjuvanted with 281 mcg AAHS and 15 mcg IMX.
985957|NCT00851643|E1|Reported Event|qHPV (GARDASIL™) - Phase A and Phase B Controls|Quadrivalent Human Papillomavirus (qHPV) (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™) combined from Phase A and Phase B.
985958|NCT00851630|B3|Baseline|Total|Total of all reporting groups
985959|NCT00851630|B2|Baseline|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
985960|NCT00851630|B1|Baseline|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
986049|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
988092|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
985961|NCT00851630|P2|Participant Flow|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
985962|NCT00851630|P1|Participant Flow|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
985963|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
985964|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
985965|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
985966|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
985967|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
985968|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
985969|NCT00851630|O2|Outcome|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
985970|NCT00851630|O1|Outcome|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
985971|NCT00851630|E2|Reported Event|Delayed|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 8 weeks after commencing antituberculous therapy
985972|NCT00851630|E1|Reported Event|Early|Initiation of fixed dose combination zidovudine (300 mg)/lamivudine (150 mg)/abacavir (300 mg) administered orally twice daily, beginning 2 weeks after commencing antituberculous therapy
985973|NCT00851591|B3|Baseline|Total|Total of all reporting groups
985974|NCT00851591|B2|Baseline|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
985975|NCT00851591|B1|Baseline|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
985976|NCT00851591|P2|Participant Flow|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
985977|NCT00851591|P1|Participant Flow|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
985978|NCT00851591|O2|Outcome|1 Group Scheduled to Receive Fenugreek|fenugreek: 3 capsules 3 times per day with a full glass of water each dose for 7 days
985979|NCT00851591|O1|Outcome|2 Group Scheduled to Receive Placebo|Psyllium: 3 capsules 3 times a day with a full glass of water each dose for 7 days
985980|NCT00851591|E2|Reported Event|2 Group Scheduled to Receive Placebo|Psyllium Category: These patients were scheduled to take 3 capsules 3 times a day with a full glass of water and each dose was for 7 days.
985981|NCT00851591|E1|Reported Event|1 Group Scheduled to Receive Fenugreek|Fenugreek Category: These patients were scheduled to take 3 capsules 3 times per day with a full glass of water and each dose was for 7 days.
985982|NCT00851552|B1|Baseline|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
985983|NCT00851552|P1|Participant Flow|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
985984|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
985985|NCT00851552|O1|Outcome|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
985986|NCT00851552|E1|Reported Event|VDR: Velcade, Doxil, and Rituxan|VELCADE - 1.3mg/m2 IV, days 1, 4, 8, 11 every 21 days x 6 cycles DOXIL - 30 mg/m2 IV, day 11 every 21 days x 6 cycles RITUXAN - 375 mg/m2 IV, day 8 every 21 days x 6 cycles
985987|NCT00851409|B1|Baseline|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
985988|NCT00851409|P1|Participant Flow|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
985989|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
985990|NCT00851409|O1|Outcome|Recombinant Human C1 Inhibitor|"Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
985991|NCT00851409|E1|Reported Event|Recombinant Human C1 Inhibitor|"Weekly administration of 50 IU/kg recombinant human C1 inhibitor~Recombinant Human C1 Inhibitor : 50 IU/kg rhC1INH, IV injection over 4 to 5 minutes, once weekly over an 8-week treatment period."
985992|NCT00851318|B5|Baseline|Total|Total of all reporting groups
985993|NCT00851318|B4|Baseline|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
985994|NCT00851318|B3|Baseline|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
985995|NCT00851318|B2|Baseline|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
985996|NCT00851318|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
985997|NCT00851318|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
985998|NCT00851318|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
985999|NCT00851318|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986000|NCT00851318|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986001|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986002|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986003|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986004|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986005|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986006|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986007|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986008|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986009|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986010|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986011|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986012|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986013|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986014|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986050|NCT00851084|E2|Reported Event|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986015|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986016|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986017|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986018|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986019|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986020|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986021|NCT00851318|O4|Outcome|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986022|NCT00851318|O3|Outcome|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986023|NCT00851318|O2|Outcome|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986024|NCT00851318|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986025|NCT00851318|E4|Reported Event|Completed Responders 400 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986026|NCT00851318|E3|Reported Event|Completed Responders 200 mg|Participants who were responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986027|NCT00851318|E2|Reported Event|Completed Non-responders 200 mg|Participants who were non-responders and completed study 275-08-001 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986028|NCT00851318|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were non-responders and discontinued study 275-08-001 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks in combination with methotrexate for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986029|NCT00851279|B1|Baseline|Magnetic Irrigated Ablation Catheter|Patients underwent ablation therapy using remote magnetic navigation, RMN (Niobe, Stereotaxis Inc.,St Louis, USA), and an irrigated RF ablation catheter (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
986030|NCT00851279|P1|Participant Flow|Magnetic Irrigated Ablation Catheter|Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system
986031|NCT00851279|O1|Outcome|Magnetic Irrigated Ablation Catheter|Either the transseptal or transaortic approach was employed to gain access for endocardial mapping/ablation during VT (entrainment mapping, activation mapping) and/or substrate mapping in sinus rhythm (elimination of fractionated/late potentials, endocardial scar homogenization) with RMN (Niobe, Stereotaxis Inc.,St Louis, USA) and irrigated RF ablation (NaviStar RMT ThermoCool, Biosense Webster,California, USA).
986032|NCT00851279|E1|Reported Event|Magnetic Irrigated Ablation Catheter|"Magnetic irrigated catheter for VT: Magnetic irrigated catheter to be used with the magnetic navigation system~There were no adverse events associated with the procedure and within a 7 to 10 days post-doc window"
986033|NCT00851084|B3|Baseline|Total|Total of all reporting groups
986034|NCT00851084|B2|Baseline|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986035|NCT00851084|B1|Baseline|mFOLFOX6 Only|modified FOLFOX6
986036|NCT00851084|P2|Participant Flow|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986037|NCT00851084|P1|Participant Flow|mFOLFOX6 Only|modified FOLFOX6
986038|NCT00851084|O2|Outcome|Positive|Positive antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
986039|NCT00851084|O1|Outcome|Negative or Missing|Negative or missing antidrug antibody (ADA) assay status at Baseline for those participants treated with aflibercept.
986040|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986041|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
986042|NCT00851084|O2|Outcome|mFOLFOX6 + Aflibercept|modified FOLFOX6 in combination with aflibercept
986043|NCT00851084|O1|Outcome|mFOLFOX6 Only|modified FOLFOX6
986051|NCT00851084|E1|Reported Event|mFOLFOX6 Only|modified FOLFOX6
986052|NCT00851006|B1|Baseline|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks. Inclusion criteria were: females 13–18 years of age with a primary diagnosis of MDD. All participants were Caucasian females.
986053|NCT00851006|P2|Participant Flow|Healthy Control Group|Only 31P MRS brain scans were used from healthy individuals. HC group were not treated.
986054|NCT00851006|P1|Participant Flow|Open Label Creatine Treatment|Participants with MDD were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks.
986055|NCT00851006|O2|Outcome|Healthy Control Group|6 healthy controls returned 8 weeks later for a follow-up scan. HC group did not receive any treatment.
986056|NCT00851006|O1|Outcome|Open Label Creatine Treatment|"MDD participants' 31P MRS scans were performed prior to the first dose of creatine, and repeated following 8 weeks of treatment.~Participants were treated with fixed-dose Creapure® brand of creatine (AlzChem LLC, Trostberg, Germany) 4 g by mouth daily for 8 weeks."
986057|NCT00851006|O1|Outcome|Open Label Creatine Treatment|The seven subjects who completed the protocol received creatine in the 1-8 week interval. Creatine was initiated at week 0 and terminated at week 8.
986058|NCT00851006|E2|Reported Event|Healthy Control Group|Healthy Control Group did not go through treatment. HC 31P MRS scans were only used for the study.
986059|NCT00851006|E1|Reported Event|Open Label Creatine Treatment|There were no serious adverse events were experienced in this study.
986060|NCT00850993|B5|Baseline|Total|Total of all reporting groups
986061|NCT00850993|B4|Baseline|Stanate® 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986062|NCT00850993|B3|Baseline|Stanate® 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986063|NCT00850993|B2|Baseline|Stanate® 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986064|NCT00850993|B1|Baseline|Placebo|Saline : Normal saline (0.9%) solution
986065|NCT00850993|P4|Participant Flow|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986066|NCT00850993|P3|Participant Flow|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986067|NCT00850993|P2|Participant Flow|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986068|NCT00850993|P1|Participant Flow|Placebo|Saline : Normal saline (0.9%) solution
986069|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986070|NCT00850993|O3|Outcome|Stannsoporfin3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986071|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986072|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
986073|NCT00850993|O4|Outcome|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986074|NCT00850993|O3|Outcome|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986075|NCT00850993|O2|Outcome|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986076|NCT00850993|O1|Outcome|Placebo|Saline : Normal saline (0.9%) solution
986077|NCT00850993|E4|Reported Event|Stannsoporfin 4.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986078|NCT00850993|E3|Reported Event|Stannsoporfin 3.0 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986138|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
986139|NCT00850603|E5|Reported Event|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
986079|NCT00850993|E2|Reported Event|Stannsoporfin 1.5 mg/kg|3 sequential cohorts of approximately 24 subjects will be recruited. Subjects in the first cohort who are randomized to receive active drug treatment will receive a single dose of 1.5 mg/kg by IM injection. Subjects in the second and third cohorts will receive 3.0 and 4.5 mg/kg, respectively.
986080|NCT00850993|E1|Reported Event|Placebo|Saline : Normal saline (0.9%) solution
986081|NCT00850889|B1|Baseline|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
986082|NCT00850889|P1|Participant Flow|Total Participants|Each participant received Juvederm on one side of the face and Restylane on the other side.
986083|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
986084|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
986085|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
986086|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
986087|NCT00850889|O1|Outcome|Total Study Participants|
986088|NCT00850889|O2|Outcome|Restylane(R) Injectable Gel|
986089|NCT00850889|O1|Outcome|Juvederm(R) Ultra Injectable Gel With Lidocaine|
986090|NCT00850889|E2|Reported Event|Restylane|
986091|NCT00850889|E1|Reported Event|Juvederm Ultra Injectable Gel With Lidocaine|
986092|NCT00850759|B5|Baseline|Total|Total of all reporting groups
986093|NCT00850759|B4|Baseline|No-contact Control|no-contact control group.
986094|NCT00850759|B3|Baseline|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
986095|NCT00850759|B2|Baseline|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
986096|NCT00850759|B1|Baseline|Virtual Reality|street-crossing training in a virtual pedestrian environment
986097|NCT00850759|P4|Participant Flow|No-contact Control|no-contact control group.
986098|NCT00850759|P3|Participant Flow|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
986099|NCT00850759|P2|Participant Flow|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
986100|NCT00850759|P1|Participant Flow|Virtual Reality|street-crossing training in a virtual pedestrian environment
986101|NCT00850759|O4|Outcome|No-contact Control|no-contact control group.
986102|NCT00850759|O3|Outcome|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
986103|NCT00850759|O2|Outcome|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
986104|NCT00850759|O1|Outcome|Virtual Reality|street-crossing training in a virtual pedestrian environment
986105|NCT00850759|E4|Reported Event|No-contact Control|no-contact control group.
986106|NCT00850759|E3|Reported Event|Streetside Training|one-on-one training in street-crossing skills by an adult, at a streetside location
986107|NCT00850759|E2|Reported Event|Computer and Video|exposure to training in pedestrian safety via computer software, internet games, and television videos
986108|NCT00850759|E1|Reported Event|Virtual Reality|street-crossing training in a virtual pedestrian environment
986109|NCT00850720|B1|Baseline|Cardiac Surgery|Infants with congenital defects.
986110|NCT00850720|P1|Participant Flow|Cardiac Surgery|Infants with congenital defects.
986111|NCT00850720|O1|Outcome|Cardiac Surgery|Infants with congenital defects.
986112|NCT00850720|E1|Reported Event|Cardiac Surgery|Infants with congenital defects.
986113|NCT00850603|B6|Baseline|Total|Total of all reporting groups
986114|NCT00850603|B5|Baseline|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
986115|NCT00850603|B4|Baseline|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
986116|NCT00850603|B3|Baseline|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
986117|NCT00850603|B2|Baseline|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
986118|NCT00850603|B1|Baseline|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
986119|NCT00850603|P5|Participant Flow|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
986120|NCT00850603|P4|Participant Flow|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
986121|NCT00850603|P3|Participant Flow|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
986122|NCT00850603|P2|Participant Flow|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
986123|NCT00850603|P1|Participant Flow|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
986124|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
986125|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
986126|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
986127|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
986128|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
986129|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
986130|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
986131|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
986132|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
986133|NCT00850603|O1|Outcome|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
986134|NCT00850603|O5|Outcome|0.15 mL Intradermal Menomune®|Participants received 0.15 mL Intradermal Menomune®
986135|NCT00850603|O4|Outcome|0.1 mL Intradermal Menomune®|Participants received 0.1 mL Intradermal Menomune®
986136|NCT00850603|O3|Outcome|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
986137|NCT00850603|O2|Outcome|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
986141|NCT00850603|E3|Reported Event|0.05 mL Intradermal Menomune®|Participants received 0.05 mL Intradermal Menomune®
986142|NCT00850603|E2|Reported Event|0.1 mL Subcutaneous Menomune®|Participants received 0.1 mL Subcutaneous Menomune®
986143|NCT00850603|E1|Reported Event|0.5 mL Subcutaneous Menomune®|Participants received 0.5 mL Subcutaneous Menomune®
986144|NCT00850564|B1|Baseline|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
986145|NCT00850564|P1|Participant Flow|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
986146|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
986147|NCT00850564|O1|Outcome|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
986148|NCT00850564|E1|Reported Event|Growth Hormone Releasing Hormone (Tesamorelin)|Growth Hormone Releasing Hormone (Tesamorelin) 2mg by subcutaneous injection once daily
986149|NCT00850538|B1|Baseline|Enrolled|"Subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
986150|NCT00850538|P1|Participant Flow|Enrolled|"Inclusion Criteria:~- subjects having primary knee replacement surgery~Exclusion Criteria:~having a revision knee replacement instead of a primary knee replacement~contraindicated for MRI or CT scans~allergy to the contrast agent gadolinium~pregnant women"
986151|NCT00850538|O1|Outcome|Specimens|Viable specimens for genetic analysis
986152|NCT00850538|E1|Reported Event|Enrolled|subjects having primary knee replacement surgery
986153|NCT00850499|B3|Baseline|Total|Total of all reporting groups
986154|NCT00850499|B2|Baseline|Rituximab + Fludarabine|
986155|NCT00850499|B1|Baseline|Velcade + Fludarabine|
986156|NCT00850499|P2|Participant Flow|Rituximab + Fludarabine|
986157|NCT00850499|P1|Participant Flow|Velcade + Fludarabine|
986158|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
986159|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
986160|NCT00850499|O2|Outcome|Rituximab + Fludarabine|Rituximab + Fludarabine
986161|NCT00850499|O1|Outcome|Velcade + Fludarabine|Velcade + Fludarabine
986162|NCT00850499|E2|Reported Event|Rituximab + Fludarabine|
986163|NCT00850499|E1|Reported Event|Velcade + Fludarabine|
986164|NCT00850460|B3|Baseline|Total|Total of all reporting groups
986165|NCT00850460|B2|Baseline|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
986166|NCT00850460|B1|Baseline|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
986167|NCT00850460|P2|Participant Flow|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
986168|NCT00850460|P1|Participant Flow|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
986169|NCT00850460|O2|Outcome|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
986170|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
986171|NCT00850460|O2|Outcome|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
986172|NCT00850460|O1|Outcome|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
986173|NCT00850460|E2|Reported Event|Statins|"Statin medications~Statins: Subjects will be randomized to continue their statin dosage or placebo for 8 weeks. They will stay on the same dosage as prescribed by their physician. Usual dosage for atorvastatin 10-80 mg/tab once daily by mouth; simvastatin 20-80 mg/tab once daily by mouth; pravastatin 10-80 mg/tab once daily by mouth; rosuvastatin 5-20 mg/tab once daily by mouth."
986174|NCT00850460|E1|Reported Event|Placebo|"Lactose placebo pill~Placebo: Placebo pills will consist of lactose and will be given one capsule once daily"
986175|NCT00850421|B1|Baseline|Botulinum Toxin Type A|
986176|NCT00850421|P1|Participant Flow|Botulinum Toxin Type A|
986177|NCT00850421|O1|Outcome|Botulinum Toxin Type A|
986178|NCT00850421|E1|Reported Event|Botulinum Toxin Type A|
986179|NCT00850395|B1|Baseline|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986180|NCT00850395|P1|Participant Flow|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986181|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986347|NCT00849901|E6|Reported Event|Placebo/Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986527|NCT00849693|E7|Reported Event|Fluoxetine 20 mg - Extension|Fluoxetine 20-40 mg, orally, once daily for 6 months
986182|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986183|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986184|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986185|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986186|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986187|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986188|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986189|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986190|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986191|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986192|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986193|NCT00850395|O1|Outcome|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986194|NCT00850395|E1|Reported Event|Maraviroc|Participants who were prescribed maraviroc tablets orally in accordance with Summary of Product Characteristics (SmPC) were observed for a period of up to 12 months or early discontinuation.
986195|NCT00850343|B5|Baseline|Total|Total of all reporting groups
986196|NCT00850343|B4|Baseline|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986197|NCT00850343|B3|Baseline|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986198|NCT00850343|B2|Baseline|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986199|NCT00850343|B1|Baseline|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986200|NCT00850343|P4|Participant Flow|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986201|NCT00850343|P3|Participant Flow|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986202|NCT00850343|P2|Participant Flow|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986203|NCT00850343|P1|Participant Flow|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986204|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986205|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986206|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986207|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986416|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
988093|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
986208|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986209|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986210|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986211|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986212|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986213|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986214|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986215|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986216|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986217|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986218|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986219|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986220|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986221|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986222|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986223|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986224|NCT00850343|O4|Outcome|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986225|NCT00850343|O3|Outcome|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986226|NCT00850343|O2|Outcome|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986227|NCT00850343|O1|Outcome|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986228|NCT00850343|E4|Reported Event|Completed Responders 400 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 400 mg certolizumab pegol by subcutaneous injection once every 4 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986229|NCT00850343|E3|Reported Event|Completed Responders 200 mg|Participants who were ACR20 responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986230|NCT00850343|E2|Reported Event|Completed Non-responders 200 mg|Participants who were ACR20 non-responders and completed study 275-08-003 at Week 24 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986231|NCT00850343|E1|Reported Event|Discontinued Non-responders 200 mg|Participants who were ACR20 non-responders and discontinued study 275-08-003 at Week 16 received 200 mg certolizumab pegol by subcutaneous injection once every 2 weeks for up to 52 weeks or until approval of certolizumab pegol for rheumatoid arthritis in Japan.
986232|NCT00850200|B1|Baseline|Proton Therapy Plan Compared to IMRT and Conventional RT|Each patient has a proton, IMRT and conventional plan done prior to treatment for dosimetric comparison of the primary endpoint which is the percent of the body that receives 4 Gray (%V4). The plan that delivers the smallest %V4 will be the plan that is pursued for actual treatment. Therefore, each patient will have three treatment plans, but will only be treated with one of these three plans (the superior one).
986233|NCT00850200|P1|Participant Flow|Optimal Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
986234|NCT00850200|O3|Outcome|Intensity Modulated Radiation Plan|Intensity Modulated Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
986235|NCT00850200|O2|Outcome|Conventional Photon Radiation Plan|Conventional Photon Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
986236|NCT00850200|O1|Outcome|Proton Radiation Plan|Proton Radiation Plan: Between 21-39.6 Gy/CGE to the PTV
986237|NCT00850200|E1|Reported Event|Superior Treatment Plan|"Each patient has three radiation treatment plans conducted prior to initiation of treatment (proton, IMRT, conventional). Only the plan that's found to be the most optimal in regard to minimizing the heart v4 is the one that was actually used to treat the patient. In this case, the proton plan was found to be the optimal plan in each case; patients were therefore treated with proton therapy between 21-39.6 Gray (Gy)/Centigray Equivalents (CGE) to the planning target volume (PTV).~The primary endpoint of this study is the paired differences among the three plans. Thus there's just one treatment arm."
986238|NCT00850174|B3|Baseline|Total|Total of all reporting groups
986239|NCT00850174|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
986240|NCT00850174|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
986241|NCT00850174|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
986242|NCT00850174|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
986243|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986244|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986245|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986246|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986247|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986248|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986249|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986250|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986251|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986252|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986253|NCT00850174|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986254|NCT00850174|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986255|NCT00850135|B1|Baseline|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
986256|NCT00850135|P1|Participant Flow|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
986257|NCT00850135|O2|Outcome|Participants With AUC 130 >22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
986258|NCT00850135|O1|Outcome|Participants With AUC 130 <= 22,000|AUC-130 values were divided into“high” and “low” at a cutoff of 22,000, which was the 90th percentile of AUC-130 values.
986259|NCT00850135|O1|Outcome|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
986301|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986260|NCT00850135|E1|Reported Event|Continuous Glucose Monitor for Diabetes in Pregnancy Screening|The Seven Continuous Glucose Monitoring System: Between 24-28 weeks of gestation, the recommended period of glucola testing, a soft sensor for continuous glucose monitoring system (CGMS) will be inserted superficially under the skin. The patient will be instructed on how to wear and care for the device. She will wear the CGMS for 7 days, then return to the clinic for removal of the device, and downloading of the data. Finger stick blood glucoses will be checked by the patient 2 times daily during the 7 days of wearing the CGMS.
986261|NCT00850096|B3|Baseline|Total|Total of all reporting groups
986262|NCT00850096|B2|Baseline|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
986263|NCT00850096|B1|Baseline|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
986264|NCT00850096|P2|Participant Flow|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
986265|NCT00850096|P1|Participant Flow|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
986266|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
986267|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
986268|NCT00850096|O2|Outcome|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
986269|NCT00850096|O1|Outcome|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
986270|NCT00850096|E2|Reported Event|Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two (50 IU) or four (100 IU) sprays of Nasulin (intranasal insulin spray 1%) administered three times daily just prior to meals for 6 weeks.
986271|NCT00850096|E1|Reported Event|Placebo for Nasulin|Basal insulin (glargine) administered as a 1x daily injection in the morning and two placebo sprays administered three times daily just prior to meals for 6 weeks.
986272|NCT00850070|B3|Baseline|Total|Total of all reporting groups
986273|NCT00850070|B2|Baseline|Placebo|sugar pill
986274|NCT00850070|B1|Baseline|Sapropterin|tetrahydrobiopterin (BH4)
986275|NCT00850070|P2|Participant Flow|Placebo|sugar pill; matched identical tablet, dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
986276|NCT00850070|P1|Participant Flow|Sapropterin|tetrahydrobiopterin (BH4); dosage was 20mg/kg/day administered once per day orally in tablet form. Pills could be crushed and mixed with a variety of food substances (e.g., liquids or solids).
986277|NCT00850070|O2|Outcome|Placebo|sugar pill
986278|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
986279|NCT00850070|O2|Outcome|Placebo|sugar pill
986280|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
986281|NCT00850070|O2|Outcome|Placebo|sugar pill
986282|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
986283|NCT00850070|O2|Outcome|Placebo|sugar pill
986284|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
986285|NCT00850070|O2|Outcome|Placebo|sugar pill
986286|NCT00850070|O1|Outcome|Sapropterin|tetrahydrobiopterin (BH4)
986287|NCT00850070|O2|Outcome|Placebo|sugar pill
986288|NCT00850070|O1|Outcome|Sapropterin|sapropterin 20 mg/kg/day
986289|NCT00850070|E2|Reported Event|Placebo|sugar pill
986290|NCT00850070|E1|Reported Event|Sapropterin|sapropterin 20 mg/kg/day
986291|NCT00850031|B1|Baseline|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: Inlay implanted in cornea for improvement of near vision"
986292|NCT00850031|P1|Participant Flow|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
986293|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
986294|NCT00850031|O1|Outcome|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
986295|NCT00850031|E1|Reported Event|AcuFocus Corneal Inlay|"Implantation of the AcuFocus Corneal Inlay in emmetropic presbyopic patients.~AcuFocus Corneal Inlay ACI 7000PDT: corneal inlay"
986296|NCT00849940|B1|Baseline|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986297|NCT00849940|P1|Participant Flow|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986298|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986299|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986300|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986302|NCT00849940|O1|Outcome|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986303|NCT00849940|E1|Reported Event|CAS NIRS FORE-SIGHT Oximeter|"Pediatric patients presenting for cardiac catheterization.~CAS NIRS FORE-SIGHT oximeter: Comparison of non-invasive tissue oxygen saturation with blood sample-derived (calculated) tissue oxygen saturation."
986304|NCT00849901|B4|Baseline|Total|Total of all reporting groups
986305|NCT00849901|B3|Baseline|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986306|NCT00849901|B2|Baseline|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986307|NCT00849901|B1|Baseline|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986308|NCT00849901|P3|Participant Flow|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986309|NCT00849901|P2|Participant Flow|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986310|NCT00849901|P1|Participant Flow|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986311|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986312|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986313|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986314|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
986315|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
986316|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
986317|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986318|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986319|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986320|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
986321|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
986322|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
986323|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986324|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986325|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986326|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
986327|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
986328|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
986329|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986330|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986331|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986332|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
986333|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
986334|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
986335|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986336|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986337|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986338|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
986339|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
986340|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
986341|NCT00849901|O3|Outcome|Placebo/Duloxetine|Received placebo PO, QD during acute treatment phase, and duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986342|NCT00849901|O2|Outcome|Fluoxetine/Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during both acute treatment phase and extension phase
986343|NCT00849901|O1|Outcome|Duloxetine/Duloxetine|Received duloxetine 60, 90, and/or 120 milligram (mg) orally (PO), once daily (QD) during both acute treatment phase and extension phase
986344|NCT00849901|O3|Outcome|Placebo|Received placebo PO, QD during acute treatment phase
986345|NCT00849901|O2|Outcome|Fluoxetine|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
986346|NCT00849901|O1|Outcome|Duloxetine|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
990657|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
986348|NCT00849901|E5|Reported Event|Fluoxetine - Extension|Received fluoxetine 20 and/or 40 mg PO, QD during extension phase. One participant had discontinued the acute phase due to an adverse event but was accidentally dispensed drug at the last visit of the acute phase, thus based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs) (resulting in one more participant being analyzed for AEs than started the extension phase in the Participant Flow section).
986349|NCT00849901|E4|Reported Event|Duloxetine - Extension|Received duloxetine 60, 90, and/or 120 mg PO, QD during extension phase
986350|NCT00849901|E3|Reported Event|Placebo - Acute|Received placebo PO, QD during acute treatment phase
986351|NCT00849901|E2|Reported Event|Fluoxetine - Acute|Received fluoxetine 20 and/or 40 mg PO, QD during acute treatment phase
986352|NCT00849901|E1|Reported Event|Duloxetine - Acute|Received duloxetine 60, 90, and/or 120 mg orally (PO), once daily (QD) during acute treatment phase
986353|NCT00849875|B4|Baseline|Total|Total of all reporting groups
986354|NCT00849875|B3|Baseline|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986355|NCT00849875|B2|Baseline|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986356|NCT00849875|B1|Baseline|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986357|NCT00849875|P1|Participant Flow|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986358|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986359|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986360|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986361|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986362|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986363|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986364|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986365|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986366|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986367|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986368|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986369|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986370|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986371|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986372|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986373|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986374|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986375|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986376|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986377|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986378|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986379|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986380|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986381|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986382|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986383|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986384|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986385|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986386|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986387|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986388|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986389|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986390|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986391|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986392|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986393|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986394|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986395|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986396|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986397|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986398|NCT00849875|O3|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986399|NCT00849875|O2|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986400|NCT00849875|O1|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986401|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986402|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986403|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986404|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986405|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986406|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986407|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986408|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986409|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening
986410|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986411|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986412|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986413|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986414|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986415|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
990658|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
986417|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986418|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986419|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986420|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986421|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986422|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986423|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986424|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986425|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening
986426|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986427|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986428|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986429|NCT00849875|O4|Outcome|GSK2132231A GS Unknown Group|Subset of patients with unknown status as regards GS signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986430|NCT00849875|O3|Outcome|GSK2132231A GS- Group|Subset of patients without the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986431|NCT00849875|O2|Outcome|GSK2132231A GS+ Group|Subset of patients with the pre-specified gene signature, receiving the GSK2132231A product. Gene-signature sub-grouping was based on patients having a potentially predictive gene signature, as assessed at screening.
986432|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986433|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986434|NCT00849875|O1|Outcome|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986435|NCT00849875|E1|Reported Event|GSK2132231A GROUP|Patients planned to receive intramuscularly up to 24 doses of GSK2132231A, in 4 cycles.
986436|NCT00849862|B3|Baseline|Total|Total of all reporting groups
986437|NCT00849862|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
986438|NCT00849862|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
986439|NCT00849862|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
986440|NCT00849862|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra 750 mg Tablet (reference) dosed in second period
986441|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
986442|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
986443|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
986444|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
986445|NCT00849862|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
986446|NCT00849862|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
986447|NCT00849810|B1|Baseline|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
986448|NCT00849810|P1|Participant Flow|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
986486|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986526|NCT00849693|E8|Reported Event|Placebo/Duloxetine - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
986449|NCT00849810|O1|Outcome|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
986450|NCT00849810|E1|Reported Event|Metoprolol to Nebivolol|"Patients entered the study on metoprolol succinate, at stable dose of dose of 25-200mg daily for 4 weeks. Patients had ambulatory blood pressure assessment at their current dose and then were changed to a comparable dose of nebivolol. Ambulatory blood pressure assessment was repeated after approximately 4 to 5 weeks, at a stable dose.~Metoprolol : Metoprolol tablets 25-200 mg daily times four weeks. Nebivolol daily for 4-5 weeks, 5-20 mg."
986451|NCT00849797|B3|Baseline|Total|Total of all reporting groups
986452|NCT00849797|B2|Baseline|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
986453|NCT00849797|B1|Baseline|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
986454|NCT00849797|P2|Participant Flow|Trileptal® (Reference) First|Trileptal® 600 mg Tablet (reference) dosed in first period followed by Oxcarbazepine 600 mg Tablet (test) dosed in second period
986455|NCT00849797|P1|Participant Flow|Oxcarbazepine (Test) First|Oxcarbazepine 600 mg Tablet (test) dosed in first period followed by Trileptal® 600 mg Tablet (reference) dosed in second period
986456|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986457|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986458|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986459|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986460|NCT00849797|O2|Outcome|Trileptal|Trileptal® 600 mg Tablet (reference) dosed in either period
986461|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986462|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986463|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986464|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986465|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986466|NCT00849797|O2|Outcome|Trileptal®|Trileptal® 600 mg Tablet (reference) dosed in either period
986467|NCT00849797|O1|Outcome|Oxcarbazepine|Oxcarbazepine 600 mg Tablet (test) dosed in either period
986468|NCT00849693|B5|Baseline|Total|Total of all reporting groups
986469|NCT00849693|B4|Baseline|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986470|NCT00849693|B3|Baseline|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986471|NCT00849693|B2|Baseline|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986472|NCT00849693|B1|Baseline|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986473|NCT00849693|P4|Participant Flow|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986474|NCT00849693|P3|Participant Flow|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986475|NCT00849693|P2|Participant Flow|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986476|NCT00849693|P1|Participant Flow|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986477|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986478|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986479|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986480|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986481|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
986482|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
986483|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
986484|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
986485|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
990659|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
986487|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986488|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986489|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
986490|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
986491|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
986492|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
986493|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986494|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986495|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986496|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986497|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
986498|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
986499|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
986500|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
986501|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986502|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986503|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986504|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986505|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
986506|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
986507|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
986508|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
986509|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986510|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986511|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986512|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986513|NCT00849693|O4|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
986514|NCT00849693|O3|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
986515|NCT00849693|O2|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
986516|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
986517|NCT00849693|O3|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
986518|NCT00849693|O2|Outcome|Fluoxetine 20mg|Fluoxetine 20mg orally, once daily for 10 weeks
986519|NCT00849693|O1|Outcome|Duloxetine 30mg|Duloxetine 30mg orally, once daily for 10 weeks
986520|NCT00849693|O4|Outcome|Placebo/Duloxetine 60-120 mg|Participants were treated with placebo orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986521|NCT00849693|O3|Outcome|Fluoxetine 20 mg/Fluoxetine 20-40 mg|Participants were treated with Fluoxetine 20 mg orally, once daily for 10 weeks during acute treatment phase and Fluoxetine 20-40 mg orally, once daily for 6 months during extension phase
986522|NCT00849693|O2|Outcome|Duloxetine 30 mg/Duloxetine 60-120 mg|Participants were treated with Duloxetine 30 mg orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986523|NCT00849693|O1|Outcome|Duloxetine 60 mg / Duloxetine 60-120 mg|Participants were treated with Duloxetine 60 milligram (mg) orally, once daily for 10 weeks during acute treatment phase and Duloxetine 60-120 mg orally, once daily for 6 months during extension phase
986524|NCT00849693|O2|Outcome|Placebo|Placebo capsules identical in appearance, color, taste, and smell to study drug orally, once daily for 10 weeks
986525|NCT00849693|O1|Outcome|Duloxetine 60mg|Duloxetine 60mg orally, once daily for 10 weeks
986528|NCT00849693|E6|Reported Event|Duloxetine 30 mg - Extension|"Duloxetine 60-120 mg , orally, once daily for 6 months~One participant who had completed the acute treatment phase and didn't go into the extension phase, was accidentally dispensed the drug at the last visit of the acute treatment phase. Based on intent-to-treat principal, this participant was included in the extension phase analyses for adverse events (AEs; resulting in one more participant being analyzed for AEs than the number of participants who started the extension phase [see Participant Flow section])."
986529|NCT00849693|E5|Reported Event|Duloxetine 60 mg - Extension|Duloxetine 60-120 mg , orally, once daily for 6 months
986530|NCT00849693|E4|Reported Event|Placebo - Acute|Placebo capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks
986531|NCT00849693|E3|Reported Event|Fluoxetine 20 mg - Acute|Fluoxetine 20 mg, orally, once daily for 10 weeks
986532|NCT00849693|E2|Reported Event|Duloxetine 30 mg - Acute|Duloxetine 30 mg, orally, once daily for 10 weeks
986533|NCT00849693|E1|Reported Event|Duloxetine 60 mg - Acute|Duloxetine 60 mg, orally, once daily for 10 weeks
986534|NCT00849680|B9|Baseline|Total|Total of all reporting groups
986535|NCT00849680|B8|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
986536|NCT00849680|B7|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
986537|NCT00849680|B6|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
986538|NCT00849680|B5|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
986539|NCT00849680|B4|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
986540|NCT00849680|B3|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
986541|NCT00849680|B2|Baseline|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
986542|NCT00849680|B1|Baseline|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
986543|NCT00849680|P8|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
986544|NCT00849680|P7|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
986545|NCT00849680|P6|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
986546|NCT00849680|P5|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
986547|NCT00849680|P4|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
986548|NCT00849680|P3|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
986549|NCT00849680|P2|Participant Flow|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
986550|NCT00849680|P1|Participant Flow|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
986551|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
986552|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
986553|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
986554|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
986555|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
986556|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
986557|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
986558|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
986559|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
986560|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
986561|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
986562|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
990660|NCT00839241|E2|Reported Event|Allogenic Blood Transfusion|
988106|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
986563|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
986564|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
986565|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
986566|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
986567|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
986568|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
986569|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
986570|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
986571|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
986572|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
986573|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
986574|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
986575|NCT00849680|O8|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10^11 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (1x10^11 vp/dose) injected intramuscularly.
986576|NCT00849680|O7|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^10 vp/Dose)|2 or 3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^10 vp/dose) injected intramuscularly.
986577|NCT00849680|O6|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^9 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^9 vp/dose) injected intramuscularly.
986578|NCT00849680|O5|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^8 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^8 vp/dose) injected intramuscularly.
986579|NCT00849680|O4|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^7 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^7 vp/dose) injected intramuscularly.
986580|NCT00849680|O3|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10^6 vp/Dose)|3 doses of 1.0 ml of Trivalent MRKAd5 HIV-1 gag/pol/nef vaccine (3x10^6 vp/dose) injected intramuscularly.
986581|NCT00849680|O2|Outcome|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10^9 vp/Dose)|3 doses of 1.0 ml of the Monovalent MRKAd5 HIV-1 gag vaccine (1x10^9 vp/dose) injected intramuscularly.
986582|NCT00849680|O1|Outcome|Placebo|2 or 3 doses of 1.0 mg of placebo to the MRKAd5 HIV-1 gag/pol/nef vaccine or 3 doses of placebo to the MRKAd5 HIV-1 gag vaccine injected intramuscularly.
986583|NCT00849680|E8|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (1x10[11] vp/Dose)|
986584|NCT00849680|E7|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[10] vp/Dose)|
986585|NCT00849680|E6|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[9] vp/Dose)|
986586|NCT00849680|E5|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[8] vp/Dose)|
986587|NCT00849680|E4|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[7] vp/Dose)|
986588|NCT00849680|E3|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef Vaccine (3x10[6] vp/Dose)|
986589|NCT00849680|E2|Reported Event|Monovalent MRKAd5 HIV-1 Gag Vaccine (1x10[9] vp/Dose)|
986590|NCT00849680|E1|Reported Event|Placebo|
986591|NCT00849524|B1|Baseline|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
986592|NCT00849524|P1|Participant Flow|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
986593|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
986594|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
986595|NCT00849524|O1|Outcome|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
986638|NCT00849186|P1|Participant Flow|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
988094|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
986596|NCT00849524|E1|Reported Event|Ad-ISF35|"Ad-ISF35, intranodal injection, 3.3 x 10^10 ISF35 viral particles, every 2-4 weeks up to six total injections.~ISF35: Subjects participating in this study will be treated with multiple doses of Ad-ISF35 given via intranodal injection using a fixed dose of 3.3 x 10^10 ISF35 viral particles. Intranodal injections will be administered every 2-4 weeks up to six total injections."
986597|NCT00849485|B3|Baseline|Total|Total of all reporting groups
986598|NCT00849485|B2|Baseline|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
986599|NCT00849485|B1|Baseline|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
986600|NCT00849485|P2|Participant Flow|Keppra® (Reference) First|Keppra® 750 mg Tablet (reference) dosed in first period followed by Levetiracetam 750 mg Tablet (test) dosed in second period
986601|NCT00849485|P1|Participant Flow|Levetiracetam (Test) First|Levetiracetam 750 mg Tablet (test) dosed in first period followed by Keppra® 750 mg Tablet (reference) dosed in second period
986602|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
986603|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
986604|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
986605|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
986606|NCT00849485|O2|Outcome|Keppra®|Keppra® 750 mg Tablet (reference) dosed in either period
986607|NCT00849485|O1|Outcome|Levetiracetam|Levetiracetam 750 mg Tablet (test) dosed in either period
986608|NCT00849472|B1|Baseline|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986609|NCT00849472|P1|Participant Flow|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants (par.) were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986610|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986611|NCT00849472|O1|Outcome|Overall Study Arm|
986612|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986613|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986614|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986615|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986616|NCT00849472|O1|Outcome|Overall Study Arm|
986617|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986639|NCT00849186|O1|Outcome|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
986618|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986619|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986620|NCT00849472|O1|Outcome|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986621|NCT00849472|E1|Reported Event|AC, Followed by Weekly Paclitaxel and Concurrent Pazopanib|Participants were treated with intravenous (IV) doxorubicin (60 milligrams per meters squared [mg/m^2]) and cyclophosphamide (AC) (600 mg/m^2) every 21 days for 4 cycles. This was followed by weekly paclitaxel (WP) 80 mg/m^2 IV on Days 1, 8, and 15 every 28 days for 4 cycles given concurrently with oral pazopanib 800 mg (2 tablets taken at the same time each day, either 1 hour before or 2 hours after a meal) taken daily and continuing until 7 days before surgery. Pazopanib was resumed at the same oral dose 4-6 weeks after surgery and was continued daily for 6 months.
986622|NCT00849381|B1|Baseline|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
986623|NCT00849381|P1|Participant Flow|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
986624|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
986625|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
986626|NCT00849381|O1|Outcome|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
986627|NCT00849381|E1|Reported Event|Cervarix Group|Subjects who received the Hepatitis A control vaccine in the primary study (NCT00122681) and the Cervarix vaccine in the current study.
986628|NCT00849290|B1|Baseline|APC8015F|
986629|NCT00849290|P1|Participant Flow|APC8015F|APC8015F (cryopreserved autologous PBMCs, including APCs, that have been thawed and then activated in vitro with a recombinant fusion protein). Each dose contains a minimum of 3 X 10^6 CD54+ cells administered intravenously; treatment is 3 doses approximately 2 weeks apart.
986630|NCT00849290|O1|Outcome|APC8015F|
986631|NCT00849290|E1|Reported Event|APC8015F|
986632|NCT00849212|B1|Baseline|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
986633|NCT00849212|P1|Participant Flow|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
986634|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
986635|NCT00849212|O1|Outcome|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
986636|NCT00849212|E1|Reported Event|Perampanel|Orally administered E2007 (2, 4, 6, 8, 10, and 12 mg) once daily before bedtime (in fed administration insofar as possible). The dose started from 2 mg and up-titrated weekly in 2 mg increments up to the maximum 12 mg unless subjects met the following judgment on dose titration: 1.) If meeting titration limiting criteria, 2.) If subjects refused up-titration due to AEs, 3.) If the investigator judged it difficult to up-titrate due to AEs, or 4.) If treatment duration was less than 5 days. Total duration of treatment was 10 weeks from the initial dose.
986637|NCT00849186|B1|Baseline|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
986640|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
986641|NCT00849186|O1|Outcome|Sunitinib Malate (Sunitinib)|"sunitinib malate: 37.5 mg of daily oral sunitinib is given for 90 days prior to surgery~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
986642|NCT00849186|E1|Reported Event|Sunitinib|"sunitinib malate: oral~neoadjuvant therapy: IV~therapeutic conventional surgery: Surgery"
986643|NCT00849147|B1|Baseline|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986644|NCT00849147|P1|Participant Flow|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986645|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986646|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986647|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986648|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986649|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986650|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986651|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986652|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986653|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986654|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986655|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986656|NCT00849147|O1|Outcome|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986657|NCT00849147|E1|Reported Event|Haplo-marrow Transplantation|Haploidentical bone marrow transplantation using a non-myeloablative preparative regimen.
986658|NCT00849121|B3|Baseline|Total|Total of all reporting groups
986659|NCT00849121|B2|Baseline|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
986660|NCT00849121|B1|Baseline|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
986661|NCT00849121|P2|Participant Flow|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
986662|NCT00849121|P1|Participant Flow|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally (i.d.) biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered intradermally every 3 months until radiographic disease progression"
986663|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
986664|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
986665|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
986666|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
986667|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
986668|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
986669|NCT00849121|O2|Outcome|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
986670|NCT00849121|O1|Outcome|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
986671|NCT00849121|E2|Reported Event|2: pTVG-HP With rhGM-CSF Variable Dosing Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then given every 2-week, 4-week, or 3-month intervals as dictated by cellular immune response measurement.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for a minimum of 6 total doses, and continuing biweekly until evidence of T-cell immune response, and then following a booster schedule as defined by evidence of T-cell immune response."
986672|NCT00849121|E1|Reported Event|1: pTVG-HP With rhGM-CSF Every 3 Months Post Week 12|"Intradermal vaccinations of a DNA vaccine encoding PAP, with GM-CSF as an adjuvant given every 2 weeks for the first 12 weeks, then every 12 weeks until disease progression.~pTVG-HP with rhGM-CSF: pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. biweekly for 6 total doses, followed by pTVG-HP (100 µg) with rhGM-CSF (200 µg) administered i.d. every 3 months until radiographic disease progression"
986673|NCT00849108|B4|Baseline|Total|Total of all reporting groups
986674|NCT00849108|B3|Baseline|Cohort 2: Efficacy Exercise Stress|"Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at exercise stress over a 1-day period.~For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose."
986675|NCT00849108|B2|Baseline|Cohort 2: Pharm Stress|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at pharmacologic stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose.
986676|NCT00849108|B1|Baseline|Cohort 1 Dose Ranging and Dose Interval|Patients received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
986677|NCT00849108|P2|Participant Flow|Cohort 2 Preliminary Efficacy Pharmacologic Stress|Patients received 2 injections of BMS747158: 1 at rest and 1 at Pharmacologic stress, over a 1-day period.
986678|NCT00849108|P1|Participant Flow|Cohort 1 Dose Ranging and Dose Interval|Patients received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
986679|NCT00849108|O1|Outcome|Cohort 2: Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
986680|NCT00849108|O1|Outcome|Cohort 1 Dose Ranging and Dose Interval|Subjects received 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 at pharmacologic/exercise stress, over a 1-day or 2-day period
986681|NCT00849108|O1|Outcome|Cohort 2 Efficacy/Safety|Patient received BMS747158 as a single IV bolus injection at rest and a single bolus injection at stress over a 1-day period. For patients undergoing pharmacologic stress test the dose of BMS747158 were to be a factor of 2.0 to 2.4 greater than the rest dose. For patients undergoing exercise stress test the dose of BMS747158 were to be a factor of 3.0 to 3.6 greater than the rest dose.
986682|NCT00849108|O1|Outcome|Cohort 1: Dose Acquistion Time Product|Subjects received either 2 or 3 IV bolus injhections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period
986683|NCT00849108|E2|Reported Event|Cohort 2: Efficacy in Pharm Stress|"Patients receive 2 IV injections of BMS747158:at rest and stress~For the Pharmacologic (Adenosine) Stress:~Doses range at rest between 2.9 and 3.4 mCi.~Dose range at stress between 5.8 and 8.2 mCi (factor of 2.0 to 2.4 greater than the rest dose).~For the Exercise Stress:~Doses at rest were to range between 1.7 and 2.0 mCi.~Doses under stress were to be a factor of 3.0 to 3.6 greater than the rest dose, resulting in a range between 5.1 and 7.2 mCi."
986684|NCT00849108|E1|Reported Event|Cohort 1: Dose Range and Dose Interval|"Patients to receive either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during pharmacological or exercise stress, over a 1-day or 2-day period.~BMS747158: dosages at rest and at stress were not to exceed a total of 14 mCi.~Cohort 1: Patients received either 2 or 3 IV bolus injections of BMS747158: 1 at rest and 1 or 2 during stress, over a 1-day or 2-day period."
986685|NCT00849056|B3|Baseline|Total|Total of all reporting groups
986686|NCT00849056|B2|Baseline|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986687|NCT00849056|B1|Baseline|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986688|NCT00849056|P2|Participant Flow|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986689|NCT00849056|P1|Participant Flow|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986690|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986691|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986692|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986693|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986694|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986695|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986696|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986697|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986698|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986699|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986700|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986701|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
987198|NCT00848185|E2|Reported Event|GnRH Antagonist Triptorelin Trigger|GnRH antagonist protocol and triptorelin trigger
986702|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986703|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986704|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986705|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986706|NCT00849056|O2|Outcome|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986707|NCT00849056|O1|Outcome|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986708|NCT00849056|E2|Reported Event|Albiglutide 30 mg + Pioglitazone With or Without Metformin|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 mg/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986709|NCT00849056|E1|Reported Event|Placebo + Pioglitazone With or Without Metformin|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system and pioglitazone (>=30 milligrams [mg]/day, unless there was documented evidence that the participant could not tolerate that dose, in which case they were allowed 15 mg/day) with or without metformin as appropriate. Participants did not receive investigational product during the Follow-up Period.
986710|NCT00849017|B4|Baseline|Total|Total of all reporting groups
986711|NCT00849017|B3|Baseline|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986712|NCT00849017|B2|Baseline|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986713|NCT00849017|B1|Baseline|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986714|NCT00849017|P3|Participant Flow|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986715|NCT00849017|P2|Participant Flow|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986716|NCT00849017|P1|Participant Flow|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986717|NCT00849017|O2|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986718|NCT00849017|O1|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986719|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986720|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986721|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986748|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986722|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986723|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986724|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986725|NCT00849017|O3|Outcome|Albiglutide 50 mg Weekly|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986726|NCT00849017|O2|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986727|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986728|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986729|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986730|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986731|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986732|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986733|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986734|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986735|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986736|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986737|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986738|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986739|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986740|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986741|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986742|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986743|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986744|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986745|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986746|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986747|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986749|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986750|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986751|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986752|NCT00849017|O3|Outcome|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986753|NCT00849017|O2|Outcome|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986754|NCT00849017|O1|Outcome|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986755|NCT00849017|E3|Reported Event|Albiglutide 50 mg|Participants received albiglutide 30 mg from Baseline to Week 12 with a forced blinded uptitration to 50 mg at Week 12 as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986756|NCT00849017|E2|Reported Event|Albiglutide 30 mg|Participants received albiglutide 30 milligrams (mg) as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986757|NCT00849017|E1|Reported Event|Placebo|Participants received matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system. Participants did not receive investigational product during the Follow-up Period.
986758|NCT00848965|B1|Baseline|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
986759|NCT00848965|P1|Participant Flow|Placebo/FP 25, 50, 100, 200 µg|Participants received placebo/fluticasone propionate (FP) in a dose of 25, 50, 100, and 200 micrograms (µg) once daily as 1 nasal spray into each nostril from 2 separate devices for 8 days each, in a crossover design. Treatment was given in one of five sequences in Periods 1, 2, 3, and 4 (with a minimum of a 14-day washout period between treatments): ABCD, EABC, DEAB, CDEA, and BCDE (A, Placebo; B, FP 25 µg: C, FP 50 µg; D, FP 100 µg; E, FP 200 µg). On Day 8 of each treatment period (1 hour post-dose), participants entered the Vienna Challenge Chamber (VCC) for a 4-hour period, and the assessments were conducted 2-5 hours post-dose. All participants attended a follow-up visit within 2 to 4 weeks after their final dose, and the overall duration for participation in the study (screening to follow-up) did not exceed 158 days.
986760|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986761|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986762|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986763|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986764|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986765|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986766|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986767|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986768|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986769|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986770|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986771|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986772|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986773|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986774|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986775|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986776|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
987199|NCT00848185|E1|Reported Event|GnRH Antagonist - hCG Trigger|GnRH antagonist protocol and hCG trigger
986777|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986778|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986779|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986780|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986781|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986782|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986783|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986784|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986785|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986786|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986787|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986788|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986789|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986790|NCT00848965|O5|Outcome|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986791|NCT00848965|O4|Outcome|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986792|NCT00848965|O3|Outcome|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986793|NCT00848965|O2|Outcome|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986794|NCT00848965|O1|Outcome|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986795|NCT00848965|E5|Reported Event|200 µg FP|Participants received FP in a dose of 200 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986796|NCT00848965|E4|Reported Event|100 µg FP|Participants received FP in a dose of 100 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986797|NCT00848965|E3|Reported Event|50 µg FP|Participants received FP in a dose of 50 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986798|NCT00848965|E2|Reported Event|25 µg FP|Participants received FP in a dose of 25 µg once daily as 1 nasal spray into each nostril from separate devices for 8 days
986799|NCT00848965|E1|Reported Event|Placebo|Participants received identical placebo once daily as 1 nasal spray into each nostril from separate devices for 8 days
986800|NCT00848926|B1|Baseline|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986801|NCT00848926|P1|Participant Flow|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
986802|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986803|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986804|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986805|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986806|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986807|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986808|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986809|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986810|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986811|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986812|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986813|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986814|NCT00848926|O1|Outcome|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986815|NCT00848926|E1|Reported Event|Brentuximab Vedotin|Brentuximab vedotin 1.8 mg/kg every 3 weeks by IV infusion
986816|NCT00848783|B4|Baseline|Total|Total of all reporting groups
986817|NCT00848783|B3|Baseline|Induction Treatment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
986818|NCT00848783|B2|Baseline|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
986819|NCT00848783|B1|Baseline|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
987144|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
986820|NCT00848783|P3|Participant Flow|Induction Treartment Only|This is not a treatment cohort specified in the protocol. The patient in this group was not randomized to Arm A or Arm B due to disease progression before surgery and was taken off the study.
986821|NCT00848783|P2|Participant Flow|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
986822|NCT00848783|P1|Participant Flow|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
986823|NCT00848783|O2|Outcome|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
986824|NCT00848783|O1|Outcome|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
986825|NCT00848783|E2|Reported Event|B-Without IP Floxuridine|Same as Arm A except no postoperative IP treatment.
986826|NCT00848783|E1|Reported Event|A-with IP Floxuridine|"Induction treatment:~Cisplatin 25 mg/m^2 and Irinotecan 75 mg/m^2 once a week for 4 weeks, both intravenous; Two weeks without treatment; Repeat the course once.~Re-evaluation, surgery if complete response, partial response or stable disease, or off the protocol if progression of disease.~Randomization~Surgery.~Postoperative IP treatment:~Day 1,2,3: Floxuridine 3 gm/day, IP; Day 3: Cisplatin 60 mg/m^2, IP; 2 weeks without treatment; repeat the course once~Postoperative systemic treatment: courses 1-9: Capecitabine 2,000 mg/m^2/day x14 every 3 weeks/course, Oral"
986827|NCT00848744|B1|Baseline|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
986828|NCT00848744|P1|Participant Flow|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
986829|NCT00848744|O2|Outcome|Formulation B|Participants used salicylic acid Formulation A on either the right or left side of the face.
986830|NCT00848744|O1|Outcome|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
986831|NCT00848744|E1|Reported Event|Salicylic Acid|Participants used salicylic acid Formulation A and B randomized to opposite sides fo the face.on
986832|NCT00848549|B3|Baseline|Total|Total of all reporting groups
986833|NCT00848549|B2|Baseline|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986834|NCT00848549|B1|Baseline|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986835|NCT00848549|P2|Participant Flow|Carbamazepine|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986836|NCT00848549|P1|Participant Flow|Zonisamide|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986837|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986838|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986839|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986840|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986841|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986842|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986843|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986956|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
986844|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986845|NCT00848549|O2|Outcome|Carbamazepine|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986846|NCT00848549|O1|Outcome|Zonisamide|Subjects received the same study drug to which they had been randomized in the base study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986847|NCT00848549|E4|Reported Event|Carbamazepine (Base Study 310, NCT00477295)|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
986848|NCT00848549|E3|Reported Event|Zonisamide (Base Study 310, NCT00477295)|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
986849|NCT00848549|E2|Reported Event|Carbamazepine (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 400 mg and 1200 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986850|NCT00848549|E1|Reported Event|Zonisamide (Extension Study 314, NCT00848549)|Subjects received the same study drug to which they had been randomized in the core study phase and remained on their final dose for the start of the extension phase (between 200 mg and 500 mg per day). Flexible dosing was permitted as symptoms changed as long as it stayed within the dosing range.
986851|NCT00848536|B3|Baseline|Total|Total of all reporting groups
986852|NCT00848536|B2|Baseline|TRAVATAN|One drop once daily in the evening for 3 months
986853|NCT00848536|B1|Baseline|TRAVATAN APS|One drop once daily in the evening for 3 months
986854|NCT00848536|P2|Participant Flow|TRAVATAN|One drop once daily in the evening for 3 months
986855|NCT00848536|P1|Participant Flow|TRAVATAN APS|One drop once daily in the evening for 3 months
986856|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
986857|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
986858|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
986859|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
986860|NCT00848536|O2|Outcome|TRAVATAN|One drop once daily in the evening for 3 months
986861|NCT00848536|O1|Outcome|TRAVATAN APS|One drop once daily in the evening for 3 months
986862|NCT00848536|E2|Reported Event|TRAVATAN|One drop once daily in the evening for 3 months
986863|NCT00848536|E1|Reported Event|TRAVATAN APS|One drop once daily in the evening for 3 months
986864|NCT00848510|B5|Baseline|Total|Total of all reporting groups
986865|NCT00848510|B4|Baseline|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986866|NCT00848510|B3|Baseline|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986867|NCT00848510|B2|Baseline|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986868|NCT00848510|B1|Baseline|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986869|NCT00848510|P4|Participant Flow|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986957|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
987200|NCT00848172|B3|Baseline|Total|Total of all reporting groups
986870|NCT00848510|P3|Participant Flow|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986871|NCT00848510|P2|Participant Flow|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986872|NCT00848510|P1|Participant Flow|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 milligram (mg) at Weeks 1, 3 and 5. In case of clinical benefit (stable disease [SD], complete response [CR], or partial response [PR]) as assessed by the Response Evaluation Criteria in Solid Tumors version (RECIST) Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986873|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986874|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986875|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986876|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986877|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986878|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986879|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986880|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986881|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986882|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986883|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
987145|NCT00848211|E4|Reported Event|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987146|NCT00848211|E3|Reported Event|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
986884|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986885|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986886|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986887|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986888|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986889|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986890|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986891|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986892|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986893|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986894|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986895|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986896|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986897|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986958|NCT00848367|O2|Outcome|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
986898|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986899|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986900|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986901|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986902|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986903|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986904|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986905|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986906|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986907|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986908|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986909|NCT00848510|O4|Outcome|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986910|NCT00848510|O3|Outcome|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986911|NCT00848510|O2|Outcome|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986959|NCT00848367|O1|Outcome|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
986912|NCT00848510|O1|Outcome|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986913|NCT00848510|E4|Reported Event|Abituzumab 1500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986914|NCT00848510|E3|Reported Event|Abituzumab 1000 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 1000 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986915|NCT00848510|E2|Reported Event|Abituzumab 500 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 500 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986916|NCT00848510|E1|Reported Event|Abituzumab 250 mg|Abituzumab was administered as an intravenous infusion for an hour at a dose of 250 mg at Weeks 1, 3 and 5. In case of clinical benefit (SD, CR, or PR) as assessed by the RECIST Version 1.0 during initial 6 Weeks, subjects were allowed to continue treatment at the start of Week 7 at the given dose every second week until intolerance to treatment, withdrawal of consent, or the subject was no longer benefiting from treatment in the opinion of the Investigator.
986917|NCT00848497|B3|Baseline|Total|Total of all reporting groups
986918|NCT00848497|B2|Baseline|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
986919|NCT00848497|B1|Baseline|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
986920|NCT00848497|P2|Participant Flow|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
986921|NCT00848497|P1|Participant Flow|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
986922|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
986923|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
986924|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
986925|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
986926|NCT00848497|O2|Outcome|Placebo Testim + Viagra|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
986927|NCT00848497|O1|Outcome|Testim + Viagra|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
986928|NCT00848497|O2|Outcome|Placebo Testim + Viagra|"Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = 0 SHIM at 5 months = 0"
986929|NCT00848497|O1|Outcome|Testim + Viagra|"Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night~SHIM at Baseline = N/A SHIM at 5 months = N/A"
986930|NCT00848497|E2|Reported Event|Arm 2|Placebo Testim® gel (50 mg of testosterone) once daily + Viagra® 25 mg tablet every night
986931|NCT00848497|E1|Reported Event|Arm 1|Testim® gel (50 mg of testosterone)once daily + Viagra® 25 mg tablet every night
986932|NCT00848484|B3|Baseline|Total|Total of all reporting groups
986933|NCT00848484|B2|Baseline|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
986934|NCT00848484|B1|Baseline|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
986935|NCT00848484|P2|Participant Flow|Placebo / MK5757|"Patients were randomly assigned to two weeks of treatment with placebo during Treatment Period 1 followed by a 2-week washout followed by administration of MK5757 during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
987129|NCT00848211|P4|Participant Flow|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987197|NCT00848185|E3|Reported Event|Long Protocol - hCG Trigger|Long protocol and hCG trigger as control
986936|NCT00848484|P1|Participant Flow|MK5757 / Placebo|"Patients were randomly assigned to two weeks of treatment with MK5757 during Treatment Period 1 followed by a 2-week washout followed by administration of placebo during Treatment Period 2.~Patients received one orally-administered three times a Day[ter in die] (tid) dose on the first day of each treatment period. Patients titrated to two orally-administered tid doses on the second day of each Treatment Period and had the option to down-dose to one tid dose for the remainder of that treatment period.~Patients who down-dosed during Treatment Period 1 titrated to the target dose of 50 mg tid (or the placebo equivalent) during Treatment Period 2, but were permitted to down-dose if necessary. A 14-day Washout Period separated each 14-day treatment period"
986937|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986938|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986939|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986940|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986941|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986942|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986943|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986944|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986945|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986946|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986947|NCT00848484|O2|Outcome|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986948|NCT00848484|O1|Outcome|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986949|NCT00848484|E2|Reported Event|Placebo|Matching placebo 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986950|NCT00848484|E1|Reported Event|MK5757|MK5757 50 mg tid for Treatment Period 1 or Treatment Period 2 (depending on the sequence). Patients who were unable to tolerate 50 mg tid were allowed to titrate down to 25 mg tid and remained on 25 mg tid for the remainder of the treatment period.
986951|NCT00848367|B3|Baseline|Total|Total of all reporting groups
986952|NCT00848367|B2|Baseline|Low Attachment Anxiety Condition|These participants scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety.
986953|NCT00848367|B1|Baseline|High Attachment Anxiety Condition|These participants scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety.
986954|NCT00848367|P2|Participant Flow|High Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored greater than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with high attachment anxiety (i.e. others that scored above the cut off). The type of therapy provided was called Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
986955|NCT00848367|P1|Participant Flow|Low Attachment Anxiety Condition|In our study sample, the range of scores for the Need for Approval subscale of the Attachment Style Questionnaire was 1.86-5.71 (the possible range of this subscale is 1-7). Participants in this group scored lower than the cut off of 3.59 on the Need for Approval subscale of the Attachment Style questionnaire. They were assigned to therapy groups homogeneously composed of participants with low attachment anxiety (i.e. others that scored below the cut off). The type of therapy administered to this group was Group Psychodynamic Interpersonal Psychotherapy (GPIP; Tasca, G., Mikail, S. & Hewitt, P. Group Psychodynamic Interpersonal Psychotherapy: A Manual for Time Limited Treatment of Binge Eating Disorder. (2002).) Participants received 16 weekly 90 minute sessions of GPIP from a male or female therapist.
987201|NCT00848172|B2|Baseline|Sequence Placebo / OA|First day: placebo Second day: octanoic acid
986960|NCT00848367|E2|Reported Event|Low Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
986961|NCT00848367|E1|Reported Event|High Attachment Anxiety Condition|16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes.
986962|NCT00848354|B3|Baseline|Total|Total of all reporting groups
986963|NCT00848354|B2|Baseline|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986964|NCT00848354|B1|Baseline|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986965|NCT00848354|P2|Participant Flow|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986966|NCT00848354|P1|Participant Flow|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection subcutaneously (s.c.) once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986967|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986968|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986969|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986970|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986971|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986972|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986973|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986974|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986975|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986976|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986977|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986978|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986979|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986980|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986981|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987130|NCT00848211|P3|Participant Flow|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
990661|NCT00839241|E1|Reported Event|Autologous Blood Transfusion|
986982|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986983|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986984|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986985|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986986|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986987|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986988|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986989|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986990|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986991|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987131|NCT00848211|P2|Participant Flow|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
990662|NCT00839098|B4|Baseline|Total|Total of all reporting groups
986992|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986993|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986994|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986995|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986996|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986997|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986998|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
986999|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987000|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987001|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987132|NCT00848211|P1|Participant Flow|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993227|NCT00833027|E1|Reported Event|Sitagliptin 100mg|
987002|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987003|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987004|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987005|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987006|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987007|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987008|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987009|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987010|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987011|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987133|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987202|NCT00848172|B1|Baseline|Sequence OA / Placebo|First day: octanoic acid Second day: placebo
987012|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987013|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987014|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987015|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987016|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987017|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987018|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987019|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987020|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987021|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987134|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993367|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
987022|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987023|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987024|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987025|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987026|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987027|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987028|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987029|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987030|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987031|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987135|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993368|NCT00832416|O4|Outcome|4: Placebo|
987032|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987033|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987034|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987035|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987036|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987037|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987038|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987039|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987040|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987041|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987136|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993369|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
987042|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987043|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987044|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987045|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987046|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987047|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987048|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987049|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987050|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987051|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987137|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987305|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987052|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987053|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987054|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987055|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987056|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987057|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987058|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987059|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987060|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987061|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987138|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993370|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
987062|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987063|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987064|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987065|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987066|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987067|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987068|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987069|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987070|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987071|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987139|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993371|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
987072|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987073|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987074|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987075|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987076|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987077|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987078|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987079|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987080|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987081|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987140|NCT00848211|O1|Outcome|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993372|NCT00832416|O4|Outcome|4: Placebo|
987082|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987083|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987084|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987085|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987086|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987087|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987088|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987089|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987090|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987091|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987141|NCT00848211|O4|Outcome|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987306|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987092|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987093|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987094|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987095|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987096|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987097|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987098|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987099|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987100|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987101|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987142|NCT00848211|O3|Outcome|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
993373|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
987102|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987103|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987104|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987105|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987106|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987107|NCT00848354|O2|Outcome|DMARD + Methotrexate|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987108|NCT00848354|O1|Outcome|Etanercept + Methotrexate|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987109|NCT00848354|E6|Reported Event|DMARD + Methotrexate Phase 2 Year 2|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987110|NCT00848354|E5|Reported Event|Etanercept + Methotrexate Phase 2 Year 2|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987111|NCT00848354|E4|Reported Event|DMARD + Methotrexate Phase 2 Year 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987143|NCT00848211|O2|Outcome|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987112|NCT00848354|E3|Reported Event|Etanercept + Methotrexate Phase 2 Year 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987113|NCT00848354|E2|Reported Event|DMARD + Methotrexate Phase 1|Phase 1: Conventional DMARD combination therapy (SSZ or HCQ) tablets administered as per local prescribing practice, along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on DMARD (SSZ or HCQ) and methotrexate, or a DMARD the investigator preferred in accordance with the local label (HCQ, SSZ, and/or etanercept) could be added in exchange for or in addition to the Phase 1 DMARD (SSZ or HCQ). Methotrexate and the DMARD administered in Phase 1 could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987114|NCT00848354|E1|Reported Event|Etanercept + Methotrexate Phase 1|Phase 1: Etanercept 50 mg injection s.c. once weekly along with methotrexate tablet (7.5-25 mg) orally once weekly either in single dose or in 2 divided doses for 24 weeks. Phase 2: During the optional Phase 2-period (week 24-week 128), the participants could remain on etanercept and methotrexate, or a non-biologic DMARD the investigator preferred in accordance with the local label (SSZ or HCQ) could be added in exchange for or in addition to etanercept. Methotrexate could be continued, discontinued or titrated. Phase 1 reporting groups were used also for Phase 2 data, regardless of the participant`s Phase 2 treament regimen.
987115|NCT00848237|B1|Baseline|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987116|NCT00848237|P1|Participant Flow|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987117|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987118|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987119|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987120|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987121|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987122|NCT00848237|O1|Outcome|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987123|NCT00848237|E1|Reported Event|Treatment|"All Patients with Barrett's esophagus or Intestinal metaplasia which is visible endoscopically or histologically may be treated with the Radiofrequency ablation system.~Radiofrequency Ablation (HALO Ablation Systems): Subjects undergo ablation procedures (circumferential or focal) plus standard anti-secretory drug therapy (proton pump inhibitor, PPI). All Patients undergo endoscopy with biopsy in a Physician prescribed surveillance pattern after a negative biopsy."
987124|NCT00848211|B5|Baseline|Total|Total of all reporting groups
987125|NCT00848211|B4|Baseline|Placebo|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987126|NCT00848211|B3|Baseline|Group 3 (0.6mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987127|NCT00848211|B2|Baseline|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987128|NCT00848211|B1|Baseline|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987307|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987147|NCT00848211|E2|Reported Event|Group 2 (0.1mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987148|NCT00848211|E1|Reported Event|Group 1 (0.03mg TUTI-16)|Subcutaneous injection over the deltoid muscle in the upper arm on Day 0, Day 28, and Day 84
987149|NCT00848198|B1|Baseline|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
987150|NCT00848198|P1|Participant Flow|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
987151|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
987152|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
987153|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
987154|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
987155|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
987156|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
987157|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
987158|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
987159|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
987160|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
987161|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
987162|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
987163|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
987164|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
987165|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
987166|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
987167|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
987168|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
987169|NCT00848198|O3|Outcome|Participants Without Dry Eye Disease (Normal)|Subjects with composite severity score greater than 0.35
987170|NCT00848198|O2|Outcome|Participants With Mild/Moderate Dry Eye Disease|Subjects with composite severity score between 0.20 and 0.35
987171|NCT00848198|O1|Outcome|Participants With Severe Dry Eye Disease|Subjects with composite severity score less than 0.20
987172|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
987173|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
987174|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
987175|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
987176|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
987177|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
987178|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
987179|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
987180|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
987181|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
987182|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
987183|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
987184|NCT00848198|O2|Outcome|Participants Without Dry Eye Disease (Normal)|Absence of dry eye disease as defined by negative reference test
987185|NCT00848198|O1|Outcome|Participants With Dry Eye Disease|Presence of dry eye disease as defined by positive reference test
987186|NCT00848198|E1|Reported Event|Total Number of Participants|All participants who were tested using common signs and symptoms for dry eye disease
987187|NCT00848185|B4|Baseline|Total|Total of all reporting groups
987188|NCT00848185|B3|Baseline|Long Protocol-hCG|Long Protocol and hCG to trigger oocyte maturation
987189|NCT00848185|B2|Baseline|Antagonist-aGnRH to Trigger|Protocol with antagonist and 0.2 mg triptorelin to trigger oocyte maturation
987190|NCT00848185|B1|Baseline|Antagonist-hCG to Trigger|Protocol with antagonist and hCG to trigger oocyte maturation
987191|NCT00848185|P3|Participant Flow|Long Protocol hCG|Long Protocol with hCG to trigger oocyte maturation
987192|NCT00848185|P2|Participant Flow|Antagonist Trigger With hCG|Protocol with antagonist and hCG to trigger oocyte maturation
987193|NCT00848185|P1|Participant Flow|Antagonist Trigger With aGnRH|Protocol with antagonist and 0,2 mg triptorelin to trigger oocyte maturation
987194|NCT00848185|O3|Outcome|Long Protocol- hCG|Levels of VEGF in folicular fluid of patients with long protocol anf hCG for triggering
987195|NCT00848185|O2|Outcome|Antagonist-aGnRH Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol and aGnRH for triggering
987196|NCT00848185|O1|Outcome|Antagonist-hCG Levels of VEGF|Levels of VEGF in folicular fluid of patients with antagonist protocol anf hCG for triggering
987203|NCT00848172|P2|Participant Flow|Sequence Placebo / OA|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received Placebo on the second day of Visit 2, and a single oral dose of 4 mg/kg OA on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
987204|NCT00848172|P1|Participant Flow|Sequence OA / Placebo|During the 3-day inpatient Visit 2 (Drug Administration), after the admissions day (day 1 of Visit 2) patients randomized to Sequence OA / Placebo received a single oral dose of 4 mg/kg OA on the second day of Visit 2, and matching Placebo on the third day of Visit 2. Patients were discharged at the end of the third day of Visit 2, which ended this study visit.
987205|NCT00848172|O1|Outcome|Octanoic Acid AUC|
987206|NCT00848172|O1|Outcome|Octanoic Acid Tmax|
987207|NCT00848172|O2|Outcome|Placebo|
987208|NCT00848172|O1|Outcome|Octanoic Acid|
987209|NCT00848172|O2|Outcome|Placebo|
987210|NCT00848172|O1|Outcome|Octanoic Acid|
987211|NCT00848172|E3|Reported Event|Non-drug Related|AE was considered to be non-drug related, if no temporal connection was present between AE occurrence and drug administration (e.g. if AE occurred during the study, but prior to drug-administration), or an AE was clearly related to a study procedure (e.g. PICC line) rather than the study drug.
987212|NCT00848172|E2|Reported Event|Placebo|
987213|NCT00848172|E1|Reported Event|Octanoic Acid|
987214|NCT00848120|B1|Baseline|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987215|NCT00848120|P1|Participant Flow|Tocilizumab 8 Milligrams Per Kilogram (mg/kg)|Participants received tocilizumab 8 mg/kg intravenously (IV) once every 4 weeks for 24 weeks.
987216|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987217|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987218|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987219|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987220|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987221|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987222|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987223|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987224|NCT00848120|O1|Outcome|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987225|NCT00848120|E1|Reported Event|Tocilizumab 8 mg/kg|Participants received tocilizumab 8 mg/kg IV once every 4 weeks for 24 weeks.
987226|NCT00848107|B1|Baseline|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987227|NCT00848107|P1|Participant Flow|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987228|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987229|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987230|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987231|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987232|NCT00848107|O1|Outcome|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987233|NCT00848107|E1|Reported Event|Oral Treprostinil Diethanolamine|Oral Treprostinil Diethanolamine initiated at 0.25 mg and titrated up to a maximum dose of 16 mg BID or the individual's maximum tolerated dose (MTD).
987234|NCT00848081|B3|Baseline|Total|Total of all reporting groups
987235|NCT00848081|B2|Baseline|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987236|NCT00848081|B1|Baseline|Placebo|Placebo by mouth once daily for 12 weeks
987237|NCT00848081|P2|Participant Flow|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987238|NCT00848081|P1|Participant Flow|Placebo|Placebo by mouth once daily for 12 weeks
987239|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987240|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
987241|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987242|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
987243|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987244|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
987245|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987246|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
987247|NCT00848081|O2|Outcome|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987248|NCT00848081|O1|Outcome|Placebo|Placebo by mouth once daily for 12 weeks
987249|NCT00848081|E2|Reported Event|Tadalafil|Tadalafil 5 mg taken by mouth once daily for 12 weeks
987250|NCT00848081|E1|Reported Event|Placebo|Placebo by mouth once daily for 12 weeks
987251|NCT00848042|B4|Baseline|Total|Total of all reporting groups
987252|NCT00848042|B3|Baseline|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
993374|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
987253|NCT00848042|B2|Baseline|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
987254|NCT00848042|B1|Baseline|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
987255|NCT00848042|P3|Participant Flow|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
987256|NCT00848042|P2|Participant Flow|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
987257|NCT00848042|P1|Participant Flow|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
987258|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
987259|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
987260|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
987261|NCT00848042|O3|Outcome|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
987262|NCT00848042|O2|Outcome|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
987263|NCT00848042|O1|Outcome|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
987264|NCT00848042|E3|Reported Event|AuroShell-5.0|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 5 watts.
987265|NCT00848042|E2|Reported Event|AuroShell-4.5|Group treated with up to 7.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 4.5 watts.
987266|NCT00848042|E1|Reported Event|AuroShell-3.5|Group treated with the lowest treatment level with 4.5 ml/Kg of AuroShell particles concentrated to 100 Optical Density and 3.5 watts.
987267|NCT00848016|B1|Baseline|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
987268|NCT00848016|P1|Participant Flow|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
987269|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
987270|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
987271|NCT00848016|O1|Outcome|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
987272|NCT00848016|E1|Reported Event|Treatment (R-(-)-Gossypol Acetic Acid)|Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
987273|NCT00847912|B3|Baseline|Total|Total of all reporting groups
987274|NCT00847912|B2|Baseline|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
987275|NCT00847912|B1|Baseline|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
987276|NCT00847912|P2|Participant Flow|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
987277|NCT00847912|P1|Participant Flow|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
987278|NCT00847912|O2|Outcome|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
987279|NCT00847912|O1|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
987280|NCT00847912|O2|Outcome|Arm 2: Placebo, Vehicle Control|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
987281|NCT00847912|O1|Outcome|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-fluorouracil (5-FU) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
987282|NCT00847912|E2|Reported Event|Arm 2: Placebo|"Group assigned to blinded placebo, vehicle control cream applied to face and ears twice daily for maximum of 56 doses~Placebo, vehicle control: Apply thin layer of vehicle control cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily vehicle control cream, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping vehicle control cream, if and only if the participant has not received at least the minimum 2 week (28 dose) course, vehicle control cream treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but vehicle control cream will be stopped."
987283|NCT00847912|E1|Reported Event|Arm 1: 5-fluorouracil|"Group assigned to blinded 5-FU (5-fluorouracil) cream applied to face and ears twice daily for maximum of 56 doses~5-fluorouracil: Apply thin layer of topical 5-FU 5% cream twice daily to face and ears for 4 weeks. Treatment to be initiated immediately after randomization. If unable to tolerate the twice daily 5-FU, they will discontinue the treatment and initiate cool-down treatment with triamcinolone 0.1% cream twice daily until the symptoms resolve. At 3 weeks after stopping 5-FU, if and only if the participant has not received at least the minimum 2 week (28 dose) course, 5-FU treatment will be resumed on a once-daily basis to complete the 56 dose course. If this is not tolerated, the cool-down routine will be followed, but 5-FU will be stopped."
987284|NCT00847886|B3|Baseline|Total|Total of all reporting groups
987285|NCT00847886|B2|Baseline|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987286|NCT00847886|B1|Baseline|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987287|NCT00847886|P2|Participant Flow|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987288|NCT00847886|P1|Participant Flow|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987289|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987290|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987291|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987292|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987293|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987294|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987295|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987296|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987297|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987298|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987299|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987300|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987301|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987302|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987303|NCT00847886|O2|Outcome|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987304|NCT00847886|O1|Outcome|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987311|NCT00847886|E2|Reported Event|Methotrexate|Matching placebo dosing with daily oral intake for 14 days.
987312|NCT00847886|E1|Reported Event|LX3305 + Methotrexate|Daily oral intake of 100 mg LX3305 for 14 days.
987313|NCT00847808|B1|Baseline|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987314|NCT00847808|P1|Participant Flow|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987315|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987316|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987317|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987318|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987319|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987320|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987321|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987322|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987323|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987324|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987325|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987326|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987327|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987328|NCT00847808|O1|Outcome|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987329|NCT00847808|E1|Reported Event|Dexlansoprazole MR QD|Dexlansoprazole MR 30 mg, capsules and dexlansoprazole MR placebo-matching capsules, orally, each once daily for up to 6 weeks.
987330|NCT00847704|B1|Baseline|Test Group|"Device: Assisted movement and enhanced sensation~Assisted movement and enhanced sensation: Each subject will be tested before, after the 10 week treatment period and then 3 months later. Treatment sessions will occur 3 times per week and last approximately 30 minutes per treatment. The device will measure 3 of the functional tests prior to each treatment session.~Assisted movement and enhanced sensation: Thirty treatment sessions on the AMES device, each session 30 minutes of cyclic rotation of the ankle with tendon vibration. Testing before, during, and after treatments to evaluate response to treatments."
987331|NCT00847704|P1|Participant Flow|Test Group|Device: Assisted movement and enhanced sensation
987332|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
987333|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
987334|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
987335|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
987336|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
987337|NCT00847704|O1|Outcome|Test Group|Group receiving AMES therapy
987338|NCT00847704|E1|Reported Event|Test Treatment Group|Device: Subjects receiving AMES treatments.
987339|NCT00847665|B3|Baseline|Total|Total of all reporting groups
987340|NCT00847665|B2|Baseline|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987341|NCT00847665|B1|Baseline|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987342|NCT00847665|P2|Participant Flow|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987343|NCT00847665|P1|Participant Flow|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987344|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987345|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987346|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987347|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987348|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987349|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987350|NCT00847665|O2|Outcome|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987351|NCT00847665|O1|Outcome|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987352|NCT00847665|E2|Reported Event|Turning Every 2 Hours|Repositioning by the nursing staff every two hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987353|NCT00847665|E1|Reported Event|Turning Every 4 Hours|Repositioning by the nursing staff every four hours (left side, back with a 30º elevation of the head end and the foot end of the bed, right side, back), using the 30º tilt
987354|NCT00847626|B12|Baseline|Total|Total of all reporting groups
987355|NCT00847626|B11|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987356|NCT00847626|B10|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987357|NCT00847626|B9|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987358|NCT00847626|B8|Baseline|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987359|NCT00847626|B7|Baseline|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987360|NCT00847626|B6|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987361|NCT00847626|B5|Baseline|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987362|NCT00847626|B4|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987363|NCT00847626|B3|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987364|NCT00847626|B2|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987365|NCT00847626|B1|Baseline|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987366|NCT00847626|P11|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987367|NCT00847626|P10|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987368|NCT00847626|P9|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987369|NCT00847626|P8|Participant Flow|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987370|NCT00847626|P7|Participant Flow|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987371|NCT00847626|P6|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987372|NCT00847626|P5|Participant Flow|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987373|NCT00847626|P4|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987374|NCT00847626|P3|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987375|NCT00847626|P2|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987376|NCT00847626|P1|Participant Flow|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987377|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987378|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987379|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987380|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987381|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987382|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987383|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987384|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987385|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987386|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987574|NCT00847613|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987387|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987388|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987389|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987390|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987391|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987392|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987393|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987394|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987395|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987396|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987397|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987398|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987399|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987400|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987401|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987402|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987403|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987404|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987405|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987406|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987407|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987408|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987409|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987410|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987411|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987412|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987413|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987414|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987415|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987416|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987417|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987418|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987419|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987420|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987421|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987422|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987423|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987424|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987654|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987425|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987426|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987427|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987428|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987429|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987430|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987431|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987432|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987433|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987434|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987435|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987436|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987437|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987438|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987439|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987440|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987441|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987442|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987443|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987444|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987445|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987446|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987447|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987448|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987449|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987450|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987451|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987452|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987453|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987454|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987455|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987456|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987457|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987458|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987459|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987460|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987461|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987462|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
988095|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
987463|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987464|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987465|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987466|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987467|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987468|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987469|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987470|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987471|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987472|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987473|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987474|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987475|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987476|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987477|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987478|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987479|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987480|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987481|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987482|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987483|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987484|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987485|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987486|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987487|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987488|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987489|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987490|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987491|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987492|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987493|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987494|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987495|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987496|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987497|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987498|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987499|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987500|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
988096|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
987501|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987502|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987503|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987504|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987505|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987506|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987507|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987508|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987509|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987510|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987511|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987512|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987513|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987514|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987515|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987516|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987517|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987518|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987519|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987520|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987521|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987522|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987523|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987524|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987525|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987526|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987527|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987528|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987529|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987530|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987531|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987532|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987533|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987534|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987535|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987536|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987537|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987538|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987655|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987539|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987540|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987541|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987542|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987543|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987544|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.~OR~Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
987545|NCT00847626|O11|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987546|NCT00847626|O10|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987547|NCT00847626|O9|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987548|NCT00847626|O8|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987549|NCT00847626|O7|Outcome|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987550|NCT00847626|O6|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987551|NCT00847626|O5|Outcome|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987552|NCT00847626|O4|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987553|NCT00847626|O3|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987554|NCT00847626|O2|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987555|NCT00847626|O1|Outcome|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987556|NCT00847626|O3|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987557|NCT00847626|O2|Outcome|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987558|NCT00847626|O1|Outcome|Azilsartan Medoxomil 40 mg or 80 mg/Chlorthalidone 25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.~OR~Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks."
987559|NCT00847626|E11|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987560|NCT00847626|E10|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987561|NCT00847626|E9|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone placebo combination tablets, orally, once daily for up to 8 weeks.
987562|NCT00847626|E8|Reported Event|Chlorthalidone 25 mg QD|Azilsartan medoxomil placebo and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987563|NCT00847626|E7|Reported Event|Chlorthalidone 12.5 mg QD|Azilsartan medoxomil placebo and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987564|NCT00847626|E6|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987565|NCT00847626|E5|Reported Event|Azilsartan Medoxomil 80 mg/Chlorthalidone 12.5 mg QD|Azilsartan 80 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987566|NCT00847626|E4|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987567|NCT00847626|E3|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|Azilsartan 40 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987568|NCT00847626|E2|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 25 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 25 mg combination tablets, orally, once daily for up to 8 weeks.
987569|NCT00847626|E1|Reported Event|Azilsartan Medoxomil 20 mg/Chlorthalidone 12.5 mg QD|Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg combination tablets, orally, once daily for up to 8 weeks.
987570|NCT00847613|B5|Baseline|Total|Total of all reporting groups
987571|NCT00847613|B4|Baseline|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987572|NCT00847613|B3|Baseline|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987573|NCT00847613|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987575|NCT00847613|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987576|NCT00847613|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987577|NCT00847613|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987578|NCT00847613|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987579|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987580|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987581|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987582|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987583|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987584|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987585|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987586|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987587|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987588|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987589|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987590|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987591|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987592|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987593|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987594|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987595|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987596|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987597|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987598|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987599|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987600|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987796|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
993375|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
987601|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987602|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987603|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987604|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987605|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987606|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987607|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987608|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987609|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987610|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987611|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987612|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987613|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987614|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987615|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987616|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987617|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987618|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987619|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987620|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987621|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987622|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987623|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987624|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987625|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987626|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987627|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987628|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987629|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987630|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987631|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987632|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987633|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987634|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987635|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987636|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987637|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987638|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987639|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987640|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987641|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987642|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987643|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987644|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987645|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987646|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987647|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987648|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987649|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987650|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987651|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987652|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987653|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987656|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987657|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987658|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987659|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987660|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987661|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987662|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987663|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987664|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987665|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987666|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987667|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987668|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987669|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987670|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987671|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987672|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987673|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987674|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987675|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987676|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987677|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987678|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987679|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987680|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987681|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987682|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987683|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987684|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987685|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987686|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987687|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987688|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987689|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987690|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987691|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987692|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987693|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987694|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987695|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987696|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987697|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987698|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987699|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987700|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987701|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987702|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987703|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987704|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987705|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987706|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987707|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987708|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987709|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987710|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987711|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987712|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987713|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987714|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987715|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987716|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987717|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987718|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987719|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987720|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987721|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987722|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987723|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987724|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987725|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987726|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987727|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987728|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987729|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987730|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987731|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987732|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987733|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987734|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987735|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987736|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987737|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987738|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987739|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987740|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987741|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987742|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987743|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987744|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987745|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987746|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987747|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987748|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987749|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987750|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987751|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987752|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987753|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987754|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987755|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987756|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987757|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987758|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987759|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987760|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987761|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987762|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987763|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987764|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987765|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987766|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987767|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987768|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987769|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987770|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987771|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987772|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987773|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987774|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987775|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987776|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987777|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987778|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987779|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987780|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987781|NCT00847613|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts from baseline, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987782|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987783|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987784|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987785|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987786|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987787|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987788|NCT00847613|O4|Outcome|Placebo, Then CP-690,550 10 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 10 mg tablet orally twice daily up to Month 24.
987789|NCT00847613|O3|Outcome|Placebo, Then CP-690,550 5 mg|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20 percent (%) reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg tablet orally twice daily up to Month 24.
987790|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987791|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987792|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987793|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987794|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987795|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987797|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987798|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987799|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987800|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987801|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987802|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987803|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987804|NCT00847613|O3|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily for 3 to 6 months. Response was assessed at Month 3 and participants who failed to achieve at least 20% reduction from baseline in both swollen and tender joint counts, received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24. At Month 6, remaining participants received CP-690,550 5 mg or 10 mg tablet orally twice daily up to Month 24.
987805|NCT00847613|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 24.
987806|NCT00847613|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 24.
987807|NCT00847613|E8|Reported Event|CP-690,550 10 mg (Post Month 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 6, received CP-690,550 10 mg tablet orally twice daily from Month 6 to 24.
987808|NCT00847613|E7|Reported Event|CP-690,550 5 mg (Post Month 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 6, received CP-690,550 5 mg tablet orally twice daily from Month 6 to 24.
987809|NCT00847613|E6|Reported Event|Placebo (Month 3 to 6)|Participants received placebo matched to CP-690,550 tablet orally twice daily from Month 3 to 6.
987810|NCT00847613|E5|Reported Event|CP-690,550 10 mg (Month 3 to 6)|Participants who received either CP-690,550 10 mg or matching placebo up to Month 3, received CP-690,550 10 mg tablet orally twice daily from Month 3 to 6.
987811|NCT00847613|E4|Reported Event|CP-690,550 5 mg (Month 3 to 6)|Participants who received either CP-690,550 5 mg or matching placebo up to Month 3, received CP-690,550 5 mg tablet orally twice daily from Month 3 to 6.
987812|NCT00847613|E3|Reported Event|Placebo (Up to Month 3)|Participants received placebo matched to CP-690,550 tablet orally twice daily up to Month 3.
987813|NCT00847613|E2|Reported Event|CP-690,550 10 mg (Up to Month 3)|Participants received CP-690,550 10 mg tablet orally twice daily up to Month 3.
987814|NCT00847613|E1|Reported Event|CP-690,550 5 mg (Up To Month 3)|Participants received CP-690,550 5 mg tablet orally twice daily up to Month 3.
987815|NCT00847587|B3|Baseline|Total|Total of all reporting groups
987816|NCT00847587|B2|Baseline|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
987817|NCT00847587|B1|Baseline|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
987818|NCT00847587|P2|Participant Flow|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
987819|NCT00847587|P1|Participant Flow|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
987820|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
987821|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
987822|NCT00847587|O2|Outcome|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
987823|NCT00847587|O1|Outcome|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
987824|NCT00847587|E2|Reported Event|Standard Postpartum Insertion|Standard postpartum insertion of the etonogestrel contraceptive implant: insertion performed at 4-8 weeks postpartum.
987825|NCT00847587|E1|Reported Event|Early Postpartum Insertion|Early postpartum insertion of the etonogestrel contraceptive implant: insertion performed by the third postpartum day.
987826|NCT00847561|B3|Baseline|Total|Total of all reporting groups
987827|NCT00847561|B2|Baseline|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
987828|NCT00847561|B1|Baseline|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
987829|NCT00847561|P2|Participant Flow|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
987860|NCT00847301|B1|Baseline|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
987905|NCT00847210|E1|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987830|NCT00847561|P1|Participant Flow|Family-based CBT|"Family-based Cognitive Behavioral Therapy (CBT). Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
987831|NCT00847561|O2|Outcome|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
987832|NCT00847561|O1|Outcome|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
987833|NCT00847561|E2|Reported Event|Information Monitoring|"Information Monitoring. Participants will receive a packet of information about anxiety. Participants in this group will be called monthly to monitor symptoms of anxiety.~Information Monitoring: Packet providing information on strategies for coping with anxiety"
987834|NCT00847561|E1|Reported Event|Family-based CBT|"Family-based CBT. Participants will receive family-based cognitive behavioral therapy. Families in this group will learn about how to identify the signs and symptoms of anxiety, ways to cope with anxiety, relaxation techniques, and problem-solving skills. They will participate in 8, one-hour sessions, once/week with trained clinicians and 3 monthly booster sessions to reinforce what they learned.~Family-based CBT: Eight, 1-hour weekly sessions with a trained clinician."
987835|NCT00847535|B1|Baseline|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
987836|NCT00847535|P3|Participant Flow|Part II: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
987837|NCT00847535|P2|Participant Flow|Part I: Periurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
987838|NCT00847535|P1|Participant Flow|Part I: Transurethral Injection|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women. Following skeletal muscle biopsy of the thigh to obtain starting material for production of AMDC, patients underwent intrasphincteric injection of AMDC.
987839|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
987840|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
987841|NCT00847535|O1|Outcome|Patients Treated With AMDC|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
987842|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
987843|NCT00847535|O1|Outcome|Patients With Biopsy|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women.
987844|NCT00847535|E1|Reported Event|Patients|Autologous Muscle-Derived Cells (AMDC) are intended for use in the treatment of stress urinary incontinence (SUI) in women
987845|NCT00847509|B1|Baseline|[F-18]FLT Scan|
987846|NCT00847509|P1|Participant Flow|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
987847|NCT00847509|O1|Outcome|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
987848|NCT00847509|E1|Reported Event|[F-18]FLT PET Scan|Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
987849|NCT00847405|B3|Baseline|Total|Total of all reporting groups
987850|NCT00847405|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
987851|NCT00847405|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
987852|NCT00847405|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
987853|NCT00847405|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
987854|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
987855|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
987856|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
987857|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
987858|NCT00847405|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
987859|NCT00847405|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
987861|NCT00847301|P1|Participant Flow|Overall Study Design|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily
987862|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
987863|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
987864|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
987865|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
987866|NCT00847301|O1|Outcome|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
987867|NCT00847301|E1|Reported Event|All Patients|All Patients treated with dabigatran etexilate (Pradaxa), planned dose: 75 mg at the day of surgery, from the day after surgery to last treatment day 150 mg once daily.
987868|NCT00847288|B3|Baseline|Total|Total of all reporting groups
987869|NCT00847288|B2|Baseline|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
987870|NCT00847288|B1|Baseline|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
987871|NCT00847288|P2|Participant Flow|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
987872|NCT00847288|P1|Participant Flow|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
987873|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
987874|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
987875|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
987876|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
987877|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
987878|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
987879|NCT00847288|O2|Outcome|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
987880|NCT00847288|O1|Outcome|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
987881|NCT00847288|E2|Reported Event|Quarterly Review Arm|Patients enrolled at centers that are assigned to the quarterly review arm will have their device data reviewed every 3 months
987882|NCT00847288|E1|Reported Event|Monthly Review Arm|Patients enrolled at centers that are assigned to the monthly review arm will have their device data reviewed monthly
987883|NCT00847210|B3|Baseline|Total|Total of all reporting groups
987884|NCT00847210|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987885|NCT00847210|B1|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987886|NCT00847210|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987887|NCT00847210|P1|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987888|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987889|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987890|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987891|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987892|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987893|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987894|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987895|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987896|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987897|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987898|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987899|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987900|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987901|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987902|NCT00847210|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
987903|NCT00847210|O1|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.
987904|NCT00847210|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
993376|NCT00832416|O4|Outcome|4: Placebo|
987907|NCT00847197|B2|Baseline|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987908|NCT00847197|B1|Baseline|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987909|NCT00847197|P2|Participant Flow|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987910|NCT00847197|P1|Participant Flow|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987911|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987912|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987913|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987914|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987915|NCT00847197|O2|Outcome|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987916|NCT00847197|O1|Outcome|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987917|NCT00847197|E2|Reported Event|Placebo|Three 50 mg capsules placebo to MK1903 every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987918|NCT00847197|E1|Reported Event|MK1903|Three 50 mg capsules MK1903 by mouth every 8 hours for 4 weeks. All participants will receive placebo for a 2 week run-in period.
987919|NCT00847145|B9|Baseline|Total|Total of all reporting groups
987920|NCT00847145|B8|Baseline|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
987921|NCT00847145|B7|Baseline|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987922|NCT00847145|B6|Baseline|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
987923|NCT00847145|B5|Baseline|12B12M (3a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987924|NCT00847145|B4|Baseline|12M12B14B (2b)|Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
987925|NCT00847145|B3|Baseline|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
987926|NCT00847145|B2|Baseline|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
987927|NCT00847145|B1|Baseline|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987928|NCT00847145|P8|Participant Flow|12B13M_C (4b)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
987929|NCT00847145|P7|Participant Flow|12B12M_C (4a)|Previously in the parent study (NCT00657709) subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987930|NCT00847145|P6|Participant Flow|12B13M (3b)|Previously in the present study subjects had received three doses of rMenB+OMV NZ at 12 months of age respectively. These subjects one booster (fourth) dose of rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
987931|NCT00847145|P5|Participant Flow|12B12M (3a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ at 2, 4 and 6 months of age respectively. These subjects had received one booster (fourth) dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987932|NCT00847145|P4|Participant Flow|12M12B14B (2b)|Previously in the parent study (NCT00657709) subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
987933|NCT00847145|P3|Participant Flow|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
987934|NCT00847145|P2|Participant Flow|12B13M (1b)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
993377|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
987935|NCT00847145|P1|Participant Flow|12B12M (1a)|Previously in the parent study (NCT00657709) subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987936|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
987937|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
987938|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
987939|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
987940|NCT00847145|O4|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
987941|NCT00847145|O3|Outcome|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
987942|NCT00847145|O2|Outcome|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
987943|NCT00847145|O1|Outcome|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
987944|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
987945|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
987946|NCT00847145|O4|Outcome|12B13M|Combination of Groups 12B13M (1b) and 12B13M (3b).
987947|NCT00847145|O3|Outcome|12B12M|Combination of Groups 12B12M (1a) and 12B12M (3a).
987948|NCT00847145|O2|Outcome|12B13M_C (4b)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.
987949|NCT00847145|O1|Outcome|12B12M_C (4a)|Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987950|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
987951|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987952|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
987953|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
987954|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
987955|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987956|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
987957|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
987958|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.
987959|NCT00847145|O1|Outcome|12M13B15B (2a)|Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.
987960|NCT00847145|O2|Outcome|12M12B14B (2b)|Previously in the parent study subjects had received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine was given concomitantly at 12 months of age in the present study
987961|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
987962|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
987963|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
987964|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
987965|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
987966|NCT00847145|O4|Outcome|Routine246|Combined groups of 12M13B15B (2a) and 12M12B14B (2b) who previously received routine vaccine at 2, 4 an 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age [12M13B15B (2a)]; 12 and 14 months [12M12B14B (2b)] in the parent study and one dose of MMRV vaccine at 12 months of age in both the groups in the present study.
987967|NCT00847145|O3|Outcome|Men246|Combined groups of 1a and 1b who previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age and one dose of MMRV vaccine at 12 months (1a group) and at 13 months of age (1b) group in the present study.
987968|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
987969|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjets received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine
987970|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
987971|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987972|NCT00847145|O2|Outcome|12M13B15B (2a)|Previously in the parent study subjects had received only routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ at 13 and 15 months of age in the present study.
987973|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine.
987974|NCT00847145|O2|Outcome|12B13M (1b)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.
987975|NCT00847145|O1|Outcome|12B12M (1a)|Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.
987976|NCT00847145|E6|Reported Event|12B13M_C (4b)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age. These subjects received one single dose o rMenB+OMV NZ at 12 months of age and one dose of MMRV vaccine at 13 months of age in the present study.~4b - rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
987977|NCT00847145|E5|Reported Event|12B12M_C (4a)|"Previously in the parent study subjects had received three doses of Meningococcal C vaccine and routine vaccine at 2, 4 and 6 months of age respectively. These subjects had received one single dose of rMenB+OMV NZ at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~4a- rMenB+OMV NZ and routine vaccines: One dose of rMenB vaccine and one dose of routine vaccine at study month 12."
987978|NCT00847145|E4|Reported Event|12M12B14B (2b)|"Previously in the parent study subjects ahd received three doses of routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received two catch-up doses of rMenB+OMV NZ at 12 and 14 months of age and one dose of MMRV vaccine given concomitantly at 12 months of age in the present study.~2b - rMenB+OMV NZ and routine vaccines: Two doses of rMenB vaccine at study months 12 and 14 and one dose of routine vaccine at study month 12."
987979|NCT00847145|E3|Reported Event|12M13B15B (2a)|"Previously in the present study subjects had received routine vaccine at 2, 4 and 6 months of age respectively. These subjects received MMRV vaccine at 12 months of age and two catch-up doses of rMenB+OMV NZ vaccine at 13 and 15 months of age in the present study.~2a - Routine and rMenB+OMV NZ vaccines: One dose of routine vaccine at study month 12 and two doses of rMenB vaccine at study months 13 and 15."
987980|NCT00847145|E2|Reported Event|12B13M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age, respectively. These subjects received a booster (fourth) dose at 12 months and one dose of MMRV vaccine at 13 months of age in the present study.~This group is a combination of Groups 12B13M (1b) and 12B13M (3b) for safety data analysis purposes."
987981|NCT00847145|E1|Reported Event|12B12M|"Previously in the parent study subjects had received three doses of rMenB+OMV NZ and routine vaccine at 2, 4 and 6 months of age,respectively. These subjects received a booster (fourth) dose at 12 months of age concomitantly with one dose of MMRV vaccine in the present study.~This group is a combination of Groups 12B12M (1a) and 12B12M (3a) for safety data analysis purposes."
987982|NCT00847132|B3|Baseline|Total|Total of all reporting groups
987983|NCT00847132|B2|Baseline|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
987984|NCT00847132|B1|Baseline|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
987985|NCT00847132|P2|Participant Flow|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
987986|NCT00847132|P1|Participant Flow|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
987987|NCT00847132|O2|Outcome|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
987988|NCT00847132|O1|Outcome|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
987989|NCT00847132|O2|Outcome|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Usual Care Treatment: treatment as usual, providers are notified of diagnoses"
987990|NCT00847132|O1|Outcome|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative Care Treatment: depression education, treatment recommendations, coordination of care"
987991|NCT00847132|E2|Reported Event|Usual Care|"Primary medical providers are informed that the patient has depression and that treatment is recommended.~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
987992|NCT00847132|E1|Reported Event|Collaborative Care|"A study care manager provides depression education, consults with study psychiatrist to develop individualized treatment recommendations, and collaborates with patient and medical team to implement those recommendations~Collaborative care vs. usual care: depression education, treatment recommendations, coordination of care"
987993|NCT00847015|B1|Baseline|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
987994|NCT00847015|P1|Participant Flow|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
987995|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
987996|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
988097|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988098|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
987997|NCT00847015|O1|Outcome|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
987998|NCT00847015|E1|Reported Event|Gemcitabine, Cisplatin, and Sunitinib|"This is a phase II study of GCS (Gemcitabine, Cisplatin, and Sunitinib) as neoadjuvant chemotherapy in patients with muscle-invasive urothelial carcinoma of the bladder. Patients with muscle invasive urothelial carcinoma who are candidates for radical cystectomy will be enrolled.~Gemcitabine, Cisplatin, and Sunitinib: Patients will receive four cycles of GCS administered every 21 days followed by radical cystectomy. Sunitinib will be administered at a dose of 25mg orally once daily for 2 consecutive weeks followed by a 1 week rest period. Gemcitabine 1,000 mg/m2 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8."
987999|NCT00847002|B3|Baseline|Total|Total of all reporting groups
988000|NCT00847002|B2|Baseline|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
988001|NCT00847002|B1|Baseline|Standard of Care Wound Treatment|Standard Wound Care using compression
988002|NCT00847002|P2|Participant Flow|Flexitouch System|Flexitouch system with Standard Wound Care using compression
988003|NCT00847002|P1|Participant Flow|Standard of Care|Standard Wound Care using compression
988004|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
988005|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
988006|NCT00847002|O2|Outcome|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
988007|NCT00847002|O1|Outcome|Standard of Care Wound Treatment|Standard Wound Care using compression
988008|NCT00847002|E2|Reported Event|Flexitouch System With Standard of Care|Flexitouch system with Standard Wound Care using compression
988009|NCT00847002|E1|Reported Event|Standard of Care Wound Treatment|Standard Wound Care using compression
988010|NCT00846885|B3|Baseline|Total|Total of all reporting groups
988011|NCT00846885|B2|Baseline|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
988012|NCT00846885|B1|Baseline|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
988013|NCT00846885|P2|Participant Flow|Reference (Imitrex®) First|100 mg Imitrex® Tablets reference product dosed in first period followed by 100 mg Sumatriptan Tablets test product dosed in the second period.
988014|NCT00846885|P1|Participant Flow|Test (Sumatriptan) First|100 mg Sumatriptan Tablets test product dosed in first period followed by 100 mg Imitrex® Tablets reference product dosed in the second period.
988015|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
988016|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
988017|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
988018|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
988019|NCT00846885|O2|Outcome|Reference (Imitrex®)|100 mg Imitrex® Tablets reference product dosed in either period.
988020|NCT00846885|O1|Outcome|Test (Sumatriptan)|100 mg Sumatriptan Tablets test product dosed in either period.
988021|NCT00846846|B1|Baseline|Endeavor® Zotarolimus Eluting Coronary Stent System|Endeavor® Zotarolimus Eluting Coronary Stent Implantation in a patient population requiring stent implantation.
988022|NCT00846846|P1|Participant Flow|Endeavor® Zotarolimus Eluting Coronary Stent System|"Endeavor® Zotarolimus Eluting Coronary Stent System >~> Endeavor® Zotarolimus Eluting Coronary Stent System: Endeavor® Zotarolimus Eluting Coronary Stent System in a patient population requiring stent implantation"
988023|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
988024|NCT00846846|O1|Outcome|Endeavor® Zotarolimus Eluting Coronary Stent System|Intention to treat analyis has been used.
988025|NCT00846846|E1|Reported Event|Endeavor|Medtronic Endeavor
988026|NCT00846066|B3|Baseline|Total|Total of all reporting groups
988027|NCT00846066|B2|Baseline|WBT+HOT|Web Based Training plus Hands on Training
988028|NCT00846066|B1|Baseline|WBT Only|Control Group Web Based Training only
988029|NCT00846066|P2|Participant Flow|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
988030|NCT00846066|P1|Participant Flow|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
988031|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
988032|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
988033|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
988034|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
988035|NCT00846066|O2|Outcome|WBT + HOT|Web Based Training plus Hands on Training
988036|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
988037|NCT00846066|O2|Outcome|WBT+HOT|Web Based Training plus Hands on Training
988038|NCT00846066|O1|Outcome|WBT Only|Control Group Web Based Training only
988039|NCT00846066|E2|Reported Event|WBT Plus Hands on Training (HOT)|This group received WBT prior to randomization and additional Hands on Training by a Pediatric Dentist after randomization(intervention group)
988040|NCT00846066|E1|Reported Event|Web Based Training Only (WBT)|This group received only the web based training prior to randomization(control group)
988099|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988041|NCT00846027|B1|Baseline|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
988042|NCT00846027|P1|Participant Flow|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
988043|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
988044|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
988045|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
988046|NCT00846027|O1|Outcome|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
988047|NCT00846027|E1|Reported Event|Bevacizumab + Paclitaxel + Gemcitabine|Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
988048|NCT00845975|B3|Baseline|Total|Total of all reporting groups
988049|NCT00845975|B2|Baseline|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
988050|NCT00845975|B1|Baseline|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
988051|NCT00845975|P2|Participant Flow|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
988052|NCT00845975|P1|Participant Flow|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 milliwatts (mW) laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
988053|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
988054|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
988055|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
988056|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
988057|NCT00845975|O2|Outcome|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
988100|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988101|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988102|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988103|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988104|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988105|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988058|NCT00845975|O1|Outcome|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
988059|NCT00845975|E2|Reported Event|Placebo Lasers|"Inactive lasers that do not emit any therapeutic light.~Placebo Lasers : The same test site and at-home treatment administration protocols are followed, but the laser devices do not emit any therapeutic light."
988060|NCT00845975|E1|Reported Event|Erchonia Hearing Lasers #1 & #2|"Erchonia Hearing Laser #1 is a dual laser system composed of a pulsed red 7.5 mW laser of 635 nm +/- 5 nm and a pulsed green 7.5 mW laser of 532 nm, both lasers in simultaneous operation when the laser is activated.~Erchonia Hearing Laser #2 is a single diode laser that in pulsed mode emits 4.9 mW of red 635 nm +/- 5 nm light.~Erchonia Hearing Lasers #1 & #2 : Two treatments with Erchonia Hearing Laser #1 administered by the investigator at the test site, each treatment seven days apart.~Seven treatments with the Erchonia Hearing Laser #2 administered by the subject at home, one time each day for seven consecutive days, the first administration on the same day as the first administration with the Erchonia Hearing Laser #1 at the test site."
988061|NCT00846807|B1|Baseline|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988062|NCT00846807|P1|Participant Flow|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988063|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988064|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988065|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988066|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988067|NCT00846807|O1|Outcome|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988068|NCT00846807|E1|Reported Event|All Patients|treated with dabigatran etexilate (Pradaxa), planned dose: 110 mg at the day of surgery, from the day after surgery to last treatment day 220 mg once daily.
988069|NCT00846768|B1|Baseline|Study Total|Total number of patients treated in the study. This was a randomised, double-blind, active-controlled, 4 way crossover trial. 47 patients were assigned randomly to one of 4 treatment sequences in which they received each of the 4 treatments. The duration of each treatment period was 3 weeks with no washout period between treatments.
988070|NCT00846768|P4|Participant Flow|Olo 10mcg qd / Olo 5mcg Bid / Olo 2mcg Bid / Olo 5mcg qd|Patients were administered Olodaterol 10 mcg qd in the first period, Olodaterol 5 mcg bid in the second period, Olodaterol 2 mcg bid in the third period and Olodaterol 5 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
988071|NCT00846768|P3|Participant Flow|Olo 5mcg Bid / Olo 5mcg qd / Olo 10mcg qd / Olo 2mcg Bid|Patients were administered Olodaterol 5 mcg bid in the first period, Olodaterol 5 mcg qd in the second period, Olodaterol 10 mcg qd in the third period and Olodaterol 2 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
988072|NCT00846768|P2|Participant Flow|Olo 5mcg qd / Olo 2mcg Bid / Olo 5mcg Bid / Olo 10mcg qd|Patients were administered Olodaterol 5 mcg qd in the first period, Olodaterol 2 mcg bid in the second period, Olodaterol 5 mcg bid in the third period and Olodaterol 10 mcg qd in the fourth period. Olodaterol was administered via the Respimat inhaler.
988073|NCT00846768|P1|Participant Flow|Olo 2mcg Bid / Olo 10mcg qd / Olo 5mcg qd / Olo 5mcg Bid|Patients were administered Olodaterol 2 mcg bid in the first period, Olodaterol 10 mcg qd in the second period, Olodaterol 5 mcg qd in the third period and Olodaterol 5 mcg bid in the fourth period. Olodaterol was administered via the Respimat inhaler.
988074|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988075|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988076|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988077|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988078|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988079|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988080|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988081|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988082|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988083|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988084|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988085|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988086|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988087|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988088|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988089|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988090|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988091|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988107|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988108|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988109|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988110|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988111|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988112|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988113|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988114|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988115|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988116|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988117|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988118|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988119|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988120|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988121|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988122|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988123|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988124|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988125|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988126|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988127|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988128|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988129|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988130|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988131|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988132|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988133|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988134|NCT00846768|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988135|NCT00846768|O3|Outcome|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988136|NCT00846768|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988137|NCT00846768|O1|Outcome|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988138|NCT00846768|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd delivered by the Respimat Inhaler.
988139|NCT00846768|E3|Reported Event|Olo 5 mcg Bid|Olodaterol 5 mcg bid delivered by the Respimat Inhaler.
988140|NCT00846768|E2|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd delivered by the Respimat Inhaler.
988141|NCT00846768|E1|Reported Event|Olo 2 mcg Bid|Olodaterol 2 mcg bid delivered by the Respimat Inhaler.
988142|NCT00846651|B3|Baseline|Total|Total of all reporting groups
988143|NCT00846651|B2|Baseline|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988144|NCT00846651|B1|Baseline|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988145|NCT00846651|P2|Participant Flow|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988146|NCT00846651|P1|Participant Flow|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988147|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988148|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988149|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988150|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988151|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988521|NCT00845182|P2|Participant Flow|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
989017|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988152|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988153|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988154|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988155|NCT00846651|O2|Outcome|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988156|NCT00846651|O1|Outcome|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988157|NCT00846651|E2|Reported Event|Crystalloid, Then Phenylephrine Infusion|Crystalloid administration; 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988158|NCT00846651|E1|Reported Event|Colloid, Then Phenylephrine Infusion|colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min.A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
988159|NCT00846586|B3|Baseline|Total|Total of all reporting groups
988160|NCT00846586|B2|Baseline|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988161|NCT00846586|B1|Baseline|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988162|NCT00846586|P2|Participant Flow|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988163|NCT00846586|P1|Participant Flow|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988164|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988165|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988166|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988167|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988168|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988169|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988170|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988171|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988172|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988173|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988174|NCT00846586|O2|Outcome|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988175|NCT00846586|O1|Outcome|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988176|NCT00846586|E2|Reported Event|Tiotropium 18 μg|Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988177|NCT00846586|E1|Reported Event|Indacaterol 150 μg and Tiotropium 18 μg|Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer’s proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
988178|NCT00846573|B4|Baseline|Total|Total of all reporting groups
988179|NCT00846573|B3|Baseline|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988180|NCT00846573|B2|Baseline|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
988181|NCT00846573|B1|Baseline|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988182|NCT00846573|P4|Participant Flow|Healthy|"This population is made up of subjects who are considered clinically healthy. This means that there are no records of any chronic disorders or pulmonary history.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988221|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988183|NCT00846573|P3|Participant Flow|Cystic Fibrosis|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988184|NCT00846573|P2|Participant Flow|Asthma|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
988185|NCT00846573|P1|Participant Flow|COPD|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988186|NCT00846573|O3|Outcome|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988187|NCT00846573|O2|Outcome|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
988188|NCT00846573|O1|Outcome|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988189|NCT00846573|E3|Reported Event|Cystic Fibrosis Patients|"This population is made up entirely of confirmed cystic fibrosis patients. Diagnosis must be confirmed through their physician.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988190|NCT00846573|E2|Reported Event|Asthma Patients|This population is made up of only confirmed asthmatics. Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans.
988191|NCT00846573|E1|Reported Event|COPD Patients|"This population is made up of only confirmed COPD patients. Diagnosis must be confirmed through their doctor prior to enrollment.~Participants will inhale Hyperpolarized Helium-3: Participants will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. Three bags will be administered to acquire three different scans."
988192|NCT00846547|B1|Baseline|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
988193|NCT00846547|P1|Participant Flow|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
988194|NCT00846547|O1|Outcome|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
988195|NCT00846547|E1|Reported Event|Arbaclofen|Arbaclofen (STX209) : variable dose from 1mg bid to 10 mg tid, oral capsule, 8 week treatment period
988196|NCT00846521|B1|Baseline|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
988197|NCT00846521|P1|Participant Flow|Acarbose Administration|"Acarbose : Subjects assigned to treatment will receive an exact supply of Acarbose to cover the initial 5 weeks of intervention. The medication will be distributed by the investigational pharmacy. Subjects will be instructed on the dosing schedule as follows (due to potential gastrointestinal side effects, the dose will be increased incrementally to desired levels).~Tablets (dose) of acarbose: Week 1 - 25 mg once a day (with dinner); Week 2 - 50 mg once a day (with dinner); Week 3 - 25 mg with breakfast and 50 mg with dinner; Week 4 - 50 mg with breakfast, 25 mg with lunch and 50 mg with dinner; Week 5-7 - 50 mg with breakfast, 50 mg with lunch and 50 mg with dinner."
988198|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
988199|NCT00846521|O1|Outcome|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study
988200|NCT00846521|E1|Reported Event|Acarbose Administration|At baseline, subjects underwent an OGTT and 72 hr of out-patient continuous glucose monitoring. They were treated with acarbose (50 mg with meals three times daily) for 6 weeks and repeat 72 hr CGMS profiles were obtained at the end of the study.
988201|NCT00846495|B3|Baseline|Total|Total of all reporting groups
988444|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988202|NCT00846495|B2|Baseline|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988203|NCT00846495|B1|Baseline|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988204|NCT00846495|P2|Participant Flow|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988205|NCT00846495|P1|Participant Flow|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988206|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988207|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988208|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988209|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988210|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988211|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988212|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988213|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988214|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988215|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988216|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988217|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988218|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988219|NCT00846495|O1|Outcome|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988220|NCT00846495|O2|Outcome|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988518|NCT00845182|B2|Baseline|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
988222|NCT00846495|E2|Reported Event|Frovatriptan|Subjects randomized to Group B were provided with frovatriptan 5mg to be utilized during prodrome at the point they were confident a disabling migraine would occur but before the onset of headache. Subjects were provided with frovatriptan 2.5mg for rescue of persistent or recurring headache between 4 and 24 hours following treatment during prodrome.
988223|NCT00846495|E1|Reported Event|Topiramate|Subjects randomized to Group A were provided with topiramate 25mg to titrate to a maximum dosage of 100mg during Month 1. One dose adjustment was allowed with 50mg/day the required minimum dosage. Group A subjects treated with daily topiramate during Months 2 and 3 and rescued any migraine headache that occurred with frovatriptan 2.5mg.
988224|NCT00846391|B4|Baseline|Total|Total of all reporting groups
988225|NCT00846391|B3|Baseline|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
988226|NCT00846391|B2|Baseline|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
988227|NCT00846391|B1|Baseline|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
988228|NCT00846391|P3|Participant Flow|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
988229|NCT00846391|P2|Participant Flow|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
988230|NCT00846391|P1|Participant Flow|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
988231|NCT00846391|O3|Outcome|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
988232|NCT00846391|O2|Outcome|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
988233|NCT00846391|O1|Outcome|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
988234|NCT00846391|E3|Reported Event|Placebo|Patients randomized to the placebo treatment group took 2 capsules of placebo matching MK8245 capsules in the morning and 2 placebo capsules matching MK8245 capsules in the evening.
988235|NCT00846391|E2|Reported Event|MK8245 50 mg b.i.d.|Patients randomized to the 50 mg b.i.d. treatment group took 2 capsules of MK8245 25 mg in the morning and 2 capsules of MK8245 25 mg in the evening.
988236|NCT00846391|E1|Reported Event|MK8245 5 mg b.i.d.|Patients randomized to the 5 mg (twice a day) b.i.d. treatment group took 2 capsules of MK8245 2.5 mg in the morning and 2 capsules of MK8245 2.5 mg in the evening.
988237|NCT00846365|B4|Baseline|Total|Total of all reporting groups
988238|NCT00846365|B3|Baseline|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988239|NCT00846365|B2|Baseline|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988240|NCT00846365|B1|Baseline|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988241|NCT00846365|P3|Participant Flow|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988242|NCT00846365|P2|Participant Flow|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988243|NCT00846365|P1|Participant Flow|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988244|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988245|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
993378|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
988246|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988247|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988248|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988249|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988250|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988251|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988252|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988253|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988254|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988255|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988256|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988257|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988258|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988259|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988260|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988261|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988519|NCT00845182|B1|Baseline|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
988262|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988263|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988264|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988265|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988266|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988267|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988268|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988269|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988270|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988271|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988272|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988273|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988274|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988275|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988276|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988277|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988614|NCT00844857|B2|Baseline|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988278|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988279|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988280|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988281|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988282|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988283|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988284|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988285|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988286|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988287|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988288|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988289|NCT00846365|O3|Outcome|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988290|NCT00846365|O2|Outcome|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988291|NCT00846365|O1|Outcome|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988292|NCT00846365|E3|Reported Event|Olmesartan Medoxomil 20-40mg/Hydrochlorothiazide 12.5-25mg QD|"Olmesartan medoxomil 20 mg/hydrochlorothiazide 12.5 mg, tablets, orally, and Azilsartan medoxomil and chlorthalidone placebo-matching tablets, orally, once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to olmesartan medoxomil 40 mg/hydrochlorothiazide 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988293|NCT00846365|E2|Reported Event|Azilsartan Medoxomil 40-80mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5, mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 80 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988522|NCT00845182|P1|Participant Flow|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
988294|NCT00846365|E1|Reported Event|Azilsartan Medoxomil 20-40mg Plus Chlorthalidone 12.5-25 mg QD|"Azilsartan medoxomil 20 mg and chlorthalidone 12.5 mg, tablets, orally, and olmesartan medoxomil-hydrochlorothiazide placebo tablets once daily for 8 weeks.~If participant does not achieve target blood pressure at Week 4, then the dosage will be increased to azilsartan medoxomil 40 mg and chlorthalidone 25 mg, tablets, orally, once daily for the remaining 4 weeks."
988295|NCT00846287|B3|Baseline|Total|Total of all reporting groups
988296|NCT00846287|B2|Baseline|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988297|NCT00846287|B1|Baseline|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988298|NCT00846287|P2|Participant Flow|Active Comparator: Drug Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988299|NCT00846287|P1|Participant Flow|Active Comparator: Saline|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988300|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988301|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
988302|NCT00846287|O2|Outcome|Brovana Subjects|Subjects (n=10) will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988303|NCT00846287|O1|Outcome|Placebo Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag
988350|NCT00845832|B3|Baseline|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988351|NCT00845832|B2|Baseline|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988304|NCT00846287|E2|Reported Event|Drug Subjects|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988305|NCT00846287|E1|Reported Event|Saline|Subjects will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of hyperpolarized Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo will be administered and an hour will pass. The placebo consists of a nebulized saline solution (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
988306|NCT00845897|B4|Baseline|Total|Total of all reporting groups
988307|NCT00845897|B3|Baseline|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
988308|NCT00845897|B2|Baseline|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
988309|NCT00845897|B1|Baseline|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
988310|NCT00845897|P3|Participant Flow|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
988311|NCT00845897|P2|Participant Flow|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
988312|NCT00845897|P1|Participant Flow|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
988313|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
988314|NCT00845897|O2|Outcome|Placebo|Saline
988315|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
988316|NCT00845897|O3|Outcome|Botulinum Toxin 300 Units|300 units of Botox®
988317|NCT00845897|O2|Outcome|Placebo|Saline
988318|NCT00845897|O1|Outcome|Botulinum Toxin 200 Units|200 units of Botox®
988319|NCT00845897|E3|Reported Event|300 Units of Botox|300 units of botulinum toxin injected into 6 sites in the calf muscle
988320|NCT00845897|E2|Reported Event|200 Units of Botox|Total 200 units of Botulinum Toxin injected into 6 sites into the calf muscles.
988321|NCT00845897|E1|Reported Event|Placebo Group|Placebo (saline) injections into 6 sites in the calf muscle
988322|NCT00845858|B4|Baseline|Total|Total of all reporting groups
988323|NCT00845858|B3|Baseline|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
988324|NCT00845858|B2|Baseline|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988325|NCT00845858|B1|Baseline|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988326|NCT00845858|P3|Participant Flow|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
988327|NCT00845858|P2|Participant Flow|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988328|NCT00845858|P1|Participant Flow|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988329|NCT00845858|O3|Outcome|Female-Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
988330|NCT00845858|O2|Outcome|Female-Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988331|NCT00845858|O1|Outcome|Female-Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988332|NCT00845858|O3|Outcome|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
988333|NCT00845858|O2|Outcome|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988334|NCT00845858|O1|Outcome|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988335|NCT00845858|E3|Reported Event|Placebo Nasal Spray|Placebo: 30 minutes before meals and at bedtime
988336|NCT00845858|E2|Reported Event|Metoclopramide Nasal Spray 14 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988337|NCT00845858|E1|Reported Event|Metoclopramide Nasal Spray 10 mg|metoclopramide: 30 minutes before meals and at bedtime for 4 weeks
988338|NCT00845845|B3|Baseline|Total|Total of all reporting groups
988339|NCT00845845|B2|Baseline|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
988340|NCT00845845|B1|Baseline|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
988341|NCT00845845|P2|Participant Flow|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
988342|NCT00845845|P1|Participant Flow|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
988343|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
988344|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
988345|NCT00845845|O2|Outcome|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
988346|NCT00845845|O1|Outcome|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
988347|NCT00845845|E2|Reported Event|Placebo|Participants receive daily placebo and dietary counseling for 24 weeks
988348|NCT00845845|E1|Reported Event|Omega-3-acid Ethyl Esters (Lovaza)|Participants receive 4 milligrams (mg) daily of omega-3-acid ethyl esters (Lovaza) and dietary counseling for 24 weeks
988349|NCT00845832|B4|Baseline|Total|Total of all reporting groups
988412|NCT00845702|O1|Outcome|Dotarem MRA|Each subject will receive one injection of Dotarem 0.2 ml/kg.
988352|NCT00845832|B1|Baseline|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988353|NCT00845832|P3|Participant Flow|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988354|NCT00845832|P2|Participant Flow|Rituximab (0.5 Grams [g]) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988355|NCT00845832|P1|Participant Flow|Placebo + Tocilizumab (TCZ) 8 Milligrams Per Kilogram (mg/kg)|Participants received placebo intravenously (iv) on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988356|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988357|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988358|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988359|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988360|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988361|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988362|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988363|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988364|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988365|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988366|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988367|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988368|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988413|NCT00845702|E2|Reported Event|Time Of Flight MRA|Subjects undergo a TOF MRA
988414|NCT00845702|E1|Reported Event|Dotarem Magnetic Resonance Angiography|Each subject will receive one injection of Dotarem 0.2 ml/kg.
988608|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988369|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988370|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988371|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988372|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988373|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988374|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988375|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988376|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988377|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988378|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988379|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988380|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988381|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988382|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988383|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988384|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988385|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988386|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988387|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988388|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988389|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988390|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988391|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988392|NCT00845832|O3|Outcome|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988393|NCT00845832|O2|Outcome|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988394|NCT00845832|O1|Outcome|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988395|NCT00845832|E3|Reported Event|Rituximab (0.5 g) + TCZ (4 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 4 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988396|NCT00845832|E2|Reported Event|Rituximab (0.5 g) + TCZ (2 mg/kg)|Participants received rituximab 0.5 g iv on Days 1 and 15 followed by TCZ 2 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988397|NCT00845832|E1|Reported Event|Placebo + TCZ (8 mg/kg)|Participants received placebo iv on Days 1 and 15 followed by TCZ 8 mg/kg iv at Weeks 4, 8, 12 and 16. Participants also continued to receive a stable dose of methotrexate, between 7.5 and 25 mg/week orally or parenterally, as prescribed by the physician and in accordance with the local label. Participants also received a stable dose of folic acid.
988398|NCT00845728|B3|Baseline|Total|Total of all reporting groups
988399|NCT00845728|B2|Baseline|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
988400|NCT00845728|B1|Baseline|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
988401|NCT00845728|P2|Participant Flow|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
988402|NCT00845728|P1|Participant Flow|Indacaterol|"Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.~delivered via the manufacturer’s proprietary inhalation device (Handihaler®)"
988403|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
988404|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
988405|NCT00845728|O2|Outcome|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
988406|NCT00845728|O1|Outcome|Indacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
988407|NCT00845728|E2|Reported Event|Tiotropium|Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI
988408|NCT00845728|E1|Reported Event|IndIndacaterol|Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®)
988409|NCT00845702|B1|Baseline|TOF and Dotarem Enhanced MRA|Each subject will undergo a Time of Flight Magnetic Resonance Angiography followed by a Dotarem-enhanced Magnetic Resonance Angiography (with injection of Dotarem 0.2 ml/kg).
988410|NCT00845702|P1|Participant Flow|TOF Followed by Dotarem-enhanced MRA|Each patient will undergo a Time-Of-Flight Magnetic Resonance Angiography followed by an Dotarem-enhanced Magnetic Resonance Angiography(with an injection of Dotarem 0.2 ml/kg).
988411|NCT00845702|O2|Outcome|Time Of Flight MRA|Each subject will undergo a TOF MRA
988415|NCT00845676|B1|Baseline|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
988416|NCT00845676|P1|Participant Flow|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks.
988417|NCT00845676|O1|Outcome|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
988418|NCT00845676|E1|Reported Event|Experimental: Pegylated Interferon Alfa-2a + Ribavirin|Combination therapy with open-label pegylated interferon alfa-2a (PEG-IFN) + ribavirin (RBV): Pegylated interferon alfa-2a 180 mcg subcutaneous injection once weekly for 24 weeks. Ribavirin 1000-1200mg daily, dosed according to body weight and divided twice daily, for 12-24 weeks
988419|NCT00845663|B3|Baseline|Total|Total of all reporting groups
988420|NCT00845663|B2|Baseline|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988421|NCT00845663|B1|Baseline|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988422|NCT00845663|P2|Participant Flow|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988423|NCT00845663|P1|Participant Flow|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988424|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988425|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988426|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988427|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988428|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988429|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988430|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988431|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988432|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988433|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988434|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988435|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988436|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988437|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988438|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988439|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988440|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988441|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988442|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988443|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988520|NCT00845182|P3|Participant Flow|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
988445|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988446|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988447|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988448|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988449|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988450|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988451|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988452|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988453|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988454|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988455|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988456|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988457|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988458|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988459|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988460|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988461|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988462|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988463|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988464|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988465|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988466|NCT00845663|O2|Outcome|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988467|NCT00845663|O1|Outcome|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988468|NCT00845663|E2|Reported Event|Auto-Injection Device|Certolizumab pegol (CDP870) 400 mg Auto injection device (test); Auto-injection device contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988469|NCT00845663|E1|Reported Event|Pre-filled Syringe|Certolizumab pegol (CDP870) 400 mg pre-filled syringe (reference); syringe contains 1 mL of certolizumab pegol liquid formulation, 200 mg/mL ; 2 injections are given
988470|NCT00845481|B1|Baseline|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
988471|NCT00845481|P1|Participant Flow|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
988472|NCT00845481|O1|Outcome|Patients Treated With Diprosalic Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Diprosalic ointment
988473|NCT00845481|O1|Outcome|Patients Treated With Dermovat Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Dermovat ointment
988474|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment Vehicle|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® Ointment vehicle
988475|NCT00845481|O1|Outcome|Patients Treated With Elocon Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Elocon ointment
993379|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
988476|NCT00845481|O1|Outcome|Patients Treated With Betnovat® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Betnovat® ointment
988477|NCT00845481|O1|Outcome|Patients Treated With Daivobet® Ointment|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants. The treatment for this outcome measure is Daivobet® ointment
988478|NCT00845481|E1|Reported Event|Patients Treated|Treatments are given at the same time on different locations of the skin with psoriasis in the same group of participants.
988479|NCT00845429|B4|Baseline|Total|Total of all reporting groups
988480|NCT00845429|B3|Baseline|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
988481|NCT00845429|B2|Baseline|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
988482|NCT00845429|B1|Baseline|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
988483|NCT00845429|P3|Participant Flow|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
988484|NCT00845429|P2|Participant Flow|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
988485|NCT00845429|P1|Participant Flow|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
988486|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
988487|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
988488|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
988489|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
988490|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
988491|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
988492|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
988493|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
988494|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
988495|NCT00845429|O3|Outcome|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
988496|NCT00845429|O2|Outcome|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
988497|NCT00845429|O1|Outcome|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
988498|NCT00845429|E3|Reported Event|Group 3: Licensed Fluzone® Influenza Vaccine|Participants received a single dose of licensed Fluzone® influenza vaccine; 0.5 ml, intramuscularly.
988499|NCT00845429|E2|Reported Event|Group 2: High-dose Cell-Based Influenza Vaccine|Participants received a single dose of high-dose cell-based influenza vaccine; 1.0 ml, intramuscularly.
988500|NCT00845429|E1|Reported Event|Group 1: Standard Dose Cell-Based Influenza Vaccine|Participants received a single dose of standard-dose cell-based influenza vaccine; 0.5 ml, intramuscularly.
988501|NCT00845195|B3|Baseline|Total|Total of all reporting groups
988502|NCT00845195|B2|Baseline|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
988503|NCT00845195|B1|Baseline|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
988504|NCT00845195|P2|Participant Flow|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
988505|NCT00845195|P1|Participant Flow|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
988506|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
988507|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
988508|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
988509|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
988510|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
988511|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
988512|NCT00845195|O2|Outcome|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
988513|NCT00845195|O1|Outcome|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
988514|NCT00845195|E2|Reported Event|Azelastine HCl Nasal Spray, 0.1%|Azelastine HCL Nasal Spray, 137 mcg + Fluticasone Propionate Spray, 50 mcg
988515|NCT00845195|E1|Reported Event|Olopatadine HCl Nasal Spray, 0.6%|Olopatadine HCL Nasal Spray, 0.6% + Fluticasone Propionate Spray, 50 mcg
988516|NCT00845182|B4|Baseline|Total|Total of all reporting groups
988517|NCT00845182|B3|Baseline|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
993380|NCT00832416|O4|Outcome|4: Placebo|
988523|NCT00845182|O3|Outcome|Drug Pioglitazone and Drug Exentatide|"Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide~Pioglitazone and Exenatide: Pioglitazone 30mg daily for 1 month and then 45mg daily for 5 months and Exenatide 5mcg twice daily for one month then 10mcg twice daily for 5 months"
988524|NCT00845182|O2|Outcome|Exenatide|"Exenatide: 15 subjects will be randomized to receive Exenatide~Exenatide: Exenatide 5mcg twice daily for 1 month, then 10mcg twice daily for 5 months"
988525|NCT00845182|O1|Outcome|Pioglitazone|"Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm~Pioglitazone: Pioglitazone 15 mg/day for 1 month and then 45 mg/day for 5 months"
988526|NCT00845182|O3|Outcome|PIOGLITAZONE and EXNATIDE|Combinatiton of PIoglitazone and Exenatide led to weight gain of 2.7 kg
988527|NCT00845182|O2|Outcome|EXENATIDE|PIO therapy led to a weigh loss of 2.4 kg
988528|NCT00845182|O1|Outcome|PIOGLITAZONE|PIO therapy led to a weigh gain of 5.5 kg
988529|NCT00845182|E3|Reported Event|Pioglitazone and Exentatide|Pioglitazone and Exenatide: 15 subjects will be randomized to Pioglitazone and Exenatide
988530|NCT00845182|E2|Reported Event|Exenatide|Exenatide: 15 subjects will be randomized to receive Exenatide
988531|NCT00845182|E1|Reported Event|Pioglitazone|Pioglitazone: 15 Patients will be randomized to Pioglitazone only arm
988532|NCT00845130|B3|Baseline|Total|Total of all reporting groups
988533|NCT00845130|B2|Baseline|Health Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988534|NCT00845130|B1|Baseline|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988535|NCT00845130|P2|Participant Flow|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988536|NCT00845130|P1|Participant Flow|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988537|NCT00845130|O2|Outcome|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988538|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988539|NCT00845130|O2|Outcome|Healthy Subjects|Vitamin C levels in the living brain.
988540|NCT00845130|O1|Outcome|Diabetic Type II Subjects|Vitamin C level in the living brain
988541|NCT00845130|E2|Reported Event|Healthy Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988542|NCT00845130|E1|Reported Event|Diabetic Type II Subjects|Subjects received ascorbic acid (Vitamin C) infusion 1 g/kg (maximum 100gm).
988543|NCT00845065|B3|Baseline|Total|Total of all reporting groups
988544|NCT00845065|B2|Baseline|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988545|NCT00845065|B1|Baseline|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988546|NCT00845065|P2|Participant Flow|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988547|NCT00845065|P1|Participant Flow|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988548|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988549|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988550|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988551|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988552|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988553|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988554|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988609|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
993381|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
988555|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988556|NCT00845065|O2|Outcome|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988557|NCT00845065|O1|Outcome|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988558|NCT00845065|E2|Reported Event|Boceprevir/PEG2a/Ribavirin|PEG2a (180 μg/week SC) plus ribavirin (1000 to 1200 mg/day PO) for 4 weeks followed by boceprevir (800 mg TID PO, using SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided BID for 48 weeks with 24 weeks post-treatment follow-up.
988559|NCT00845065|E1|Reported Event|PEG2a/Ribavirin|Peginterferon alfa-2a (PEG2a) (180 μg/week subcutaneously [SC]) plus ribavirin (1000 to 1200 mg/day orally [PO]) for 4 weeks followed by placebo (800 mg three times a day [TID] PO, using placebo matching SCH 503034 200-mg capsules) + PEG2a 180 μg/week SC plus ribavirin 1000 to 1200 mg/day PO divided twice daily (BID) for 48 weeks with 24 weeks post-treatment follow-up.
988560|NCT00845000|B7|Baseline|Total|Total of all reporting groups
988561|NCT00845000|B6|Baseline|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988562|NCT00845000|B5|Baseline|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988563|NCT00845000|B4|Baseline|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988564|NCT00845000|B3|Baseline|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988565|NCT00845000|B2|Baseline|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988566|NCT00845000|B1|Baseline|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988567|NCT00845000|P6|Participant Flow|Placebo→ SCH 420814 100 mg→SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988568|NCT00845000|P5|Participant Flow|SCH 420814 100 mg→ SCH 420814 10 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988569|NCT00845000|P4|Participant Flow|SCH 420814 10 mg→ Placebo→ SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988610|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988611|NCT00844896|E2|Reported Event|DEF + COPE|28 subjects in this arm of the study.
988612|NCT00844896|E1|Reported Event|DEF-only|29 subjects in this arm of the study.
988570|NCT00845000|P3|Participant Flow|Placebo→SCH 420814 10 mg→SCH 420814 100 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988571|NCT00845000|P2|Participant Flow|SCH 420814 100 mg→Placebo→ SCH 420814 10 mg|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988572|NCT00845000|P1|Participant Flow|SCH 420814 10 mg→SCH 420814 100 mg→Placebo|Participants were to receive their assigned experimental treatment based on randomly assigned treatment sequence at Hour 0 following an overnight withdrawal of their antiparkinsonian medications of each treatment period. The levodopa infusion was to be started at Hour 1 and was to run for 2 hours. The participants were to also receive 25 mg of carbidopa at the following times: Hours 0, 2, and 4. Treatment periods were to be separated by at least 7 days but not more than 28 days washout between each dose.
988573|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
988574|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
988575|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
988576|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
988577|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
988578|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
988579|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
988580|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
988581|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
988582|NCT00845000|O3|Outcome|Placebo|Participants who received placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
988583|NCT00845000|O2|Outcome|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
988584|NCT00845000|O1|Outcome|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
988585|NCT00845000|E3|Reported Event|Placebo|Participants who received single oral dose of placebo in either period 1, 2, or 3 regardless of randomly assigned treatment
988586|NCT00845000|E2|Reported Event|SCH 420814 100 mg|Participants who received single oral dose of SCH 420814 100 mg (four 25 mg capsules) in either period 1, 2, or 3 regardless of randomly assigned treatment
988587|NCT00845000|E1|Reported Event|SCH 420814 10 mg|Participants who received single oral dose of SCH 420814 10 mg in either period 1, 2, or 3 regardless of randomly assigned treatment sequence
988588|NCT00844896|B3|Baseline|Total|Total of all reporting groups
988589|NCT00844896|B2|Baseline|DEF + COPE|28 subjects in this arm of the study.
988590|NCT00844896|B1|Baseline|DEF-only|29 subjects in this arm of the study.
988591|NCT00844896|P2|Participant Flow|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988592|NCT00844896|P1|Participant Flow|DEF-only|Distress Emotional Support and Family Assessment Treatment
988593|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988594|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988595|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988596|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988597|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988598|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988599|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment.
988600|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988601|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988602|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988603|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988604|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988605|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988606|NCT00844896|O1|Outcome|DEF-only|Distress Emotional Support and Family Assessment Treatment
988607|NCT00844896|O2|Outcome|DEF + COPE|Distress Emotional Support and Family Assessment Treatment and Creating Opportunities for Parent Empowerment Treatment
988615|NCT00844857|B1|Baseline|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988616|NCT00844857|P2|Participant Flow|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988617|NCT00844857|P1|Participant Flow|Olanzapine/Fluoxetine Combination|Olanzapine/fluoxetine Combination (OFC) 3 milligrams (mg) olanzapine and 25 mg fluoxetine (OFC 3/25) administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988618|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988619|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988620|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988621|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988622|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988623|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988624|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988625|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
988626|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988627|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988628|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988629|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988630|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988631|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
988632|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988633|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
988634|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988635|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988636|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988637|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988638|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988639|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988640|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988684|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
988641|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988642|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988643|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988644|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988645|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988646|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988647|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25, mg for a total of 8 weeks.
988648|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988649|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988650|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988651|NCT00844857|O1|Outcome|Olanzapine Plus Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988652|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988653|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988654|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988655|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988656|NCT00844857|O2|Outcome|Placebo|Matched placebo capsule administered orally, once daily for 8 weeks.
988657|NCT00844857|O1|Outcome|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988658|NCT00844857|E2|Reported Event|Placebo|Matched placebo capsule administered orally once daily for 8 weeks.
988659|NCT00844857|E1|Reported Event|Olanzapine/Fluoxetine Combination|OFC 3/25 mg administered orally as an initial dose beginning at randomization, 6/25 mg at Visit 3 (Day 3), 6/50 mg at Visit 4 (Week 1), and 12/50 mg at Visit 5 (Week 2). If no tolerability or safety issues occurred after Visit 5 the participant continued on the maximum tolerated dose, not to exceed 12/50 mg and not less than 6/25 mg, for a total of 8 weeks.
988660|NCT00844844|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988661|NCT00844844|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988662|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988663|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
989013|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988664|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988665|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988666|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988667|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988668|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988669|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988670|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988671|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988672|NCT00844844|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988673|NCT00844844|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988674|NCT00844805|B3|Baseline|Total|Total of all reporting groups
988675|NCT00844805|B2|Baseline|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988676|NCT00844805|B1|Baseline|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
988677|NCT00844805|P4|Participant Flow|No Treatment|For participants who achieved partial remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988678|NCT00844805|P3|Participant Flow|Naproxen|For participants who achieved partial remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988679|NCT00844805|P2|Participant Flow|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988680|NCT00844805|P1|Participant Flow|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
988681|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988682|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
988683|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
993382|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
988685|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988686|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988687|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988688|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988689|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988690|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988691|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988692|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988693|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988694|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988695|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988696|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
988697|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988698|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
988699|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988700|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
988701|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988702|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988703|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988704|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988705|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988706|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
988707|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988708|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
988709|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988710|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
988711|NCT00844805|O2|Outcome|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988712|NCT00844805|O1|Outcome|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988713|NCT00844805|O2|Outcome|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988714|NCT00844805|O1|Outcome|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase
988715|NCT00844805|E4|Reported Event|No Treatment|For participants who achieved remission during Treatment phase, no treatment was administered for an additional 24 weeks in the follow-up phase.
988716|NCT00844805|E3|Reported Event|Naproxen|For participants who achieved remission during 28-week treatment phase, naproxen was continued at a daily dose of 1000 mg administered orally for an additional 24 weeks in the follow-up phase.
988717|NCT00844805|E2|Reported Event|Placebo + Naproxen|Placebo administered intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks, during the 28-week treatment phase.
988718|NCT00844805|E1|Reported Event|Infliximab + Naproxen|Infliximab administered at a dose of 5 mg/kg intravenously on Day 1 of Weeks 0, 2, 6, 12, 18, and 24, combined with naproxen administered at a daily dose of 1000 mg for 28 weeks during the 28-week treatment phase.
988719|NCT00844753|B5|Baseline|Total|Total of all reporting groups
988720|NCT00844753|B4|Baseline|Placebo Without Parent Management Training|Sugar pill administered twice daily.
988721|NCT00844753|B3|Baseline|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988722|NCT00844753|B2|Baseline|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
988723|NCT00844753|B1|Baseline|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988724|NCT00844753|P4|Participant Flow|Placebo Without Parent Management Training|Sugar pill administered twice daily.
988725|NCT00844753|P3|Participant Flow|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988726|NCT00844753|P2|Participant Flow|Atomoxetine (ATX) Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
988727|NCT00844753|P1|Participant Flow|Atomoxetine (ATX) + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to adverse events. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training (PT)-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988728|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
988729|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988730|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
988753|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988754|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
989014|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988731|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988732|NCT00844753|O4|Outcome|Placebo Without Parent Management Training|Sugar pill administered twice daily.
988733|NCT00844753|O3|Outcome|Placebo + Parent Management Training|"Sugar pill administered twice daily~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988734|NCT00844753|O2|Outcome|Atomoxetine Without Parent Management Training|ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.
988735|NCT00844753|O1|Outcome|Atomoxetine + Parent Management Training|"ATX doses were split twice daily to prevent side effects. However, once-daily dosing was allowed if strongly preferred by a given family. ATX doses were individually adjusted according to a weight-based dosage schedule, with medical clinicians allowed to delay increases or to reduce doses due to AEs. The initial dose was 0.3 mg/kg/day (rounded to the nearest 5 mg) with weekly escalations by 0.3 mg/kg/day, unless there were limiting side effects or no further room for improvement, to a target dose of 1.2 mg/kg/day, and could be increased to a maximum of 1.8 mg/kg/day based on clinical status and response.~Parent Management Training-Families assigned to PT met weekly for individual sessions with a PT clinician. Sessions were adapted from the RUPP Parent Training Manual and covered topics such as preventing behavior problems, reinforcement, time out, and planned ignoring. Each session lasted 60 to 90 minutes and included didactic materials, videos, and role playing."
988736|NCT00844753|E2|Reported Event|Placebo|Data includes the placebo alone arm and the placebo+parent therapy arm
988737|NCT00844753|E1|Reported Event|Atomoxetine|Data includes both the ATX alone arm and the ATX+ parent therapy arm
988738|NCT00844714|B1|Baseline|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
988739|NCT00844714|P1|Participant Flow|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
988740|NCT00844714|O1|Outcome|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
988741|NCT00844714|E1|Reported Event|Rituxan|Rituxan: 1000mg rituxan by intravenous infusion on day 1 and day 15
988742|NCT00844649|B3|Baseline|Total|Total of all reporting groups
988743|NCT00844649|B2|Baseline|Gemcitabine|"Gemcitabine, 1000 mg/m^2 administered weekly for 7 weeks followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks followed by a week of rest (Cycle 2 onward).~Gemcitabine : Gemcitabine, 1000 mg/m2 administered weekly for 7 weeks, Day 1 through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks, Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)."
988744|NCT00844649|B1|Baseline|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|"ABI-007 125 mg/m^2 administered in combination with gemcitabine 1000 mg/m^2 weekly for 3 weeks followed by one week of rest.~Albumin-bound paclitaxel (ABI-007)/Gemcitabine : ABI-007 125 mg/m^2 administered in combination with Gemcitabine 1000 mg/m^2 weekly for 3 weeks, Days 1, 8, and 15 followed by one week of rest"
988745|NCT00844649|P2|Participant Flow|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988746|NCT00844649|P1|Participant Flow|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
988747|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988748|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
988749|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988750|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
988751|NCT00844649|O2|Outcome|Gemcitabine (Gem)|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988752|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine (Gem)|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
989015|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988755|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988756|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
988757|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988758|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
988759|NCT00844649|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988760|NCT00844649|O1|Outcome|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
988761|NCT00844649|E2|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 administered IV weekly for 7 weeks through Day 43 followed by a week of rest (Cycle 1), followed by cycles of weekly administration for 3 weeks on Days 1, 8, and 15 followed by a week of rest (Cycle 2 onward)
988762|NCT00844649|E1|Reported Event|Albumin-bound Paclitaxel (ABI-007)/Gemcitabine|Albumin-bound paclitaxel (ABI-007)/Gemcitabine: ABI-007 125 mg/m^2 administered intravenously (IV) in combination with Gemcitabine 1000 mg/m^2 IV weekly for 3 weeks on Days 1, 8, and 15 followed by one week of rest
988763|NCT00844597|B7|Baseline|Total|Total of all reporting groups
988764|NCT00844597|B6|Baseline|Cohort 6 - 20.0mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988765|NCT00844597|B5|Baseline|Cohort 5 - 10.0mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988766|NCT00844597|B4|Baseline|Cohort 4 - 4.0mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988767|NCT00844597|B3|Baseline|Cohort 3 - 2.0mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988768|NCT00844597|B2|Baseline|Cohort 2 - 1.0mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988769|NCT00844597|B1|Baseline|Cohort 1 - 0.5mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988770|NCT00844597|P6|Participant Flow|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group will receive a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988771|NCT00844597|P5|Participant Flow|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group will receive a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988772|NCT00844597|P4|Participant Flow|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group will receive a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988773|NCT00844597|P3|Participant Flow|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group will receive a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988774|NCT00844597|P2|Participant Flow|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group will receive a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988775|NCT00844597|P1|Participant Flow|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60-minute period
988776|NCT00844597|O6|Outcome|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988777|NCT00844597|O5|Outcome|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988778|NCT00844597|O4|Outcome|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988779|NCT00844597|O3|Outcome|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988780|NCT00844597|O2|Outcome|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988781|NCT00844597|O1|Outcome|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988782|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period~AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
988829|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988783|NCT00844597|O1|Outcome|Open Label Treatment Arm|"Subjects will be sequentially allocated to one of 6 dose level cohorts and will receive 12 weekly IV infusions of AVI-4658 in 50 mL of normal saline solution over a 60-minute period~AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
988784|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
988785|NCT00844597|O1|Outcome|Open Label Treatment Arm|"AVI-4658 for Injection: AVI-4658 for Injection, is packaged as 100 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:~Cohort 1: 0.5mg/kg once weekly for 12 weeks; Cohort 2: 1.0mg/kg once weekly for 12 weeks; Cohort 3: 2.0mg/kg once weekly for 12 weeks; Cohort 4: 4.0mg/kg once weekly for 12 weeks; Cohort 5: 10.0mg/kg once weekly for 12 weeks; Cohort 6: 20.0mg/kg once weekly for 12 weeks"
988786|NCT00844597|E6|Reported Event|Cohort 6 - 20.0 mg/kg/wk|Subjects in this group received a 20.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988787|NCT00844597|E5|Reported Event|Cohort 5 - 10.0 mg/kg/wk|Subjects in this group received a 10.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988788|NCT00844597|E4|Reported Event|Cohort 4 - 4.0 mg/kg/wk|Subjects in this group received a 4.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988789|NCT00844597|E3|Reported Event|Cohort 3 - 2.0 mg/kg/wk|Subjects in this group received a 2.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988790|NCT00844597|E2|Reported Event|Cohort 2 - 1.0 mg/kg/wk|Subjects in this group received a 1.0 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988791|NCT00844597|E1|Reported Event|Cohort 1 - 0.5 mg/kg/wk|Subjects in this group received a 0.5 mg/kg/wk dose of AVI-4658 over 12 weekly IV infusions in 50 mL of normal saline solution over a 60 minute period
988792|NCT00844558|B3|Baseline|Total|Total of all reporting groups
988793|NCT00844558|B2|Baseline|Control|The control participants received their usual care for symptomatic knee osteoarthritis (OA) through their usual healthcare providers and were not asked to make changes to their lifestyle.Usual care for these subjects may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery, and/or physical therapy.
988794|NCT00844558|B1|Baseline|Gait|The gait participants were randomized and attended 24 biweekly 45-minute sessions directed by a physical therapist, which were composed of guided strategies to optimize knee movements during treadmill walking, using computerized motion analysis with visual biofeedback.
988795|NCT00844558|P2|Participant Flow|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
988796|NCT00844558|P1|Participant Flow|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
988797|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
988798|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
988799|NCT00844558|O2|Outcome|Control|"Gait Training Control Group Participants~Control: There is no intervention associated with this arm of the study"
988800|NCT00844558|O1|Outcome|Gait Training|"Gait Training Intervention Group Participants~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
988801|NCT00844558|O2|Outcome|Control|No adverse events
988802|NCT00844558|O1|Outcome|Gait|No adverse events
988803|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
988804|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
988805|NCT00844558|O2|Outcome|Control|"Control Group~Control: There is no intervention associated with this arm of the study"
988806|NCT00844558|O1|Outcome|Gait|"Gait Training Arm~Gait Training: Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months"
988807|NCT00844558|O2|Outcome|Control Group|No adverse events
988808|NCT00844558|O1|Outcome|Gait|No adverse events
988809|NCT00844558|E2|Reported Event|Control|Usual care for symptomatic knee OA through their usual healthcare providers and were not asked to make changes in their lifestyle. Usual care may have included a yearly visit with their physician, use of pain medications for knee symptoms, knee surgery and/or physical therapy.
988810|NCT00844558|E1|Reported Event|Gait|Gait training with a physical therapist 2/week for the first 3 months followed by 1/week for the following 3 months
988811|NCT00844545|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988812|NCT00844545|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988813|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988814|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988815|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988816|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988817|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988818|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988819|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988820|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988821|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988822|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988823|NCT00844545|O1|Outcome|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange
988824|NCT00844545|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose – 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988825|NCT00844532|B1|Baseline|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988826|NCT00844532|P1|Participant Flow|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988827|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988828|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988921|NCT00844480|P2|Participant Flow|Placebo|placebo: iv
993383|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
988830|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988831|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988832|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988833|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988834|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988835|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988836|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988837|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988838|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988839|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988840|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988841|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988842|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988843|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988844|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988845|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988846|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988847|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988848|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988849|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988850|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988922|NCT00844480|P1|Participant Flow|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
988923|NCT00844480|O2|Outcome|Placebo|placebo: iv
988924|NCT00844480|O1|Outcome|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
988851|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988852|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988853|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988854|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988855|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988856|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988857|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988858|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988859|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988860|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988861|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988862|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988863|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988864|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988865|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988866|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988867|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988868|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988869|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988870|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988871|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988925|NCT00844480|O2|Outcome|Placebo|placebo: iv
988926|NCT00844480|O1|Outcome|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
988927|NCT00844480|E2|Reported Event|Placebo|placebo: iv
988872|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988873|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988874|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988875|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988876|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988877|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988878|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988879|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988880|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988881|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988882|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988883|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988884|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988885|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988886|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988887|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988888|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988889|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988890|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988891|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988892|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988928|NCT00844480|E1|Reported Event|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
989016|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988893|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988894|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988895|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988896|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988897|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988898|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988899|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988900|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988901|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988902|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988903|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988904|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988905|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988906|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988907|NCT00844532|O1|Outcome|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988908|NCT00844532|E1|Reported Event|Absolute Pro™ Peripheral Self-Expanding Stent System|The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.
988909|NCT00844519|B3|Baseline|Total|Total of all reporting groups
988910|NCT00844519|B2|Baseline|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
988911|NCT00844519|B1|Baseline|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
988912|NCT00844519|P2|Participant Flow|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
988913|NCT00844519|P1|Participant Flow|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc will be 150mg by mouth twice daily.
988914|NCT00844519|O2|Outcome|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
988915|NCT00844519|O1|Outcome|Maraviroc|maraviroc 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
988916|NCT00844519|E2|Reported Event|Placebo|matching placebo pill 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen.
988917|NCT00844519|E1|Reported Event|Maraviroc|maraviroc at 300mg by mouth twice daily for 24 weeks in addition to current anti-HIV medication regimen. For subjects on ritonavir, the dose of maraviroc was 150mg by mouth twice daily.
988918|NCT00844480|B3|Baseline|Total|Total of all reporting groups
988919|NCT00844480|B2|Baseline|Placebo|placebo: iv
988920|NCT00844480|B1|Baseline|Zoledronic Acid|zoledronic acid: zoledronic acid, 5mg, iv
988929|NCT00844428|B1|Baseline|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988930|NCT00844428|P1|Participant Flow|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988931|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988932|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988933|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988934|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988935|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988936|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988937|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988938|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988939|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988940|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988941|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988942|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
989009|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989010|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989011|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988943|NCT00844428|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988944|NCT00844428|E1|Reported Event|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
988945|NCT00844415|B1|Baseline|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
988946|NCT00844415|P1|Participant Flow|All Patients (Pat.)|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
988947|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
988948|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
988949|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
988950|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
988951|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
988952|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
989012|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988953|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
988954|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
988955|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. However, for the two patients who received a dose of 125 mg dabigatran followed by 150 mg BID, and the one patient who received only a single dose of dabigatran (75 mg), no summary statistics were calculated, due to sparse data.
988956|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient's weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient's weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
988957|NCT00844415|O1|Outcome|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
988958|NCT00844415|E1|Reported Event|All Patients|Dabigatran was administered twice daily for three consecutive days (total 6 doses). All patients received an initial oral dose of 1.71mg/kg of dabigatran (80 percent of the adult dose of 150 mg/70 kg adjusted for the patient’s weight). Based on thrombin time (TT) and clinical assessment, the dose was adjusted to the target dose of 2.14 mg/kg of dabigatran (100 percent of the adult dose adjusted for the patient’s weight). Three patients received 75 mg dabigatran (first dose) followed by 100 mg twice daily (BID). Three patients took dabigatran 100 mg (first dose) followed by 125 mg BID. Two patients received a dose of 125 mg dabigatran followed by 150 mg BID. One patient received only a single dose of dabigatran (75 mg).
988959|NCT00844376|B1|Baseline|All Participants|
988960|NCT00844376|P2|Participant Flow|Reference Drug First (Atorvastatin Tablet)|80-mg Commercial atorvastatin tablet (Lipitor®) as a single dose in the first intervention period and 80-mg EP suspension atorvastatin prototype formulation as a single dose in the second intervention period. Period 2 began immediately after period 1.
988961|NCT00844376|P1|Participant Flow|Test Drug First (Atorvastatin EP Suspension)|80-milligram (mg) Extemporaneous preparation (EP) suspension atorvastatin prototype formulation as a single dose in the first intervention period and commercial (reference) 80 mg atorvastatin tablet (Lipitor®) as a single dose in the second intervention period. Period 2 began immediately after period 1.
988962|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988963|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
988964|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988965|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
988966|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988967|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
988968|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988969|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
988970|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988971|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
988972|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988973|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
988974|NCT00844376|O2|Outcome|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988975|NCT00844376|O1|Outcome|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
988976|NCT00844376|E2|Reported Event|Reference|80-mg Commercial atorvastatin tablet (Lipitor®)
988977|NCT00844376|E1|Reported Event|Test|80-mg Extemporaneous preparation suspension Atorvastatin prototype formulation
989440|NCT00843180|B1|Baseline|Massage|massage and acupressure up to 3x/week for entire hospital stay
988978|NCT00844298|B1|Baseline|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
988979|NCT00844298|P1|Participant Flow|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
988980|NCT00844298|O1|Outcome|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
988981|NCT00844298|E1|Reported Event|Nilotinib+mVPD|"Patients who were Philadelphia-positive, newly-diagnosed adult ALL and treated with nilotinib + mVPD treatment plan~Nilotinib+mVPD: 1.Induction:~Daunorubicin 90 mg/m2/day by continuous iv infusion (d1-3)~Vincristine 2 mg iv push (d1, 8, 15, 22)~Prednisolone 60 mg/m2/day po (d1-28)~Nilotinib 400mg bid/d (d8-) 2.Consolidation A (cycle1)~Daunorubicin 45 mg/m2/day by continuous iv (d1, 2)~Vincristine 2 mg iv (d1, 8)~Prednisolone 60 mg/m2/day po (d1-14)~Nilotinib 400mg bid/d~3. Consolidation B (cycles 2&4)~Cytarabine 2,000 mg/m2/day iv over 2 hours (d1-4)~Etoposide 150 mg/m2/day iv over 3 hours (d1-4)~Nilotinib 400mg bid/d~4.Consolidation C (cycles 3&5)~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hours (d1-2, 15-16)~Leucovorin followed immediately by 50 mg/m2 iv every 6hrs for three doses,~Nilotinib 400mg bid/d~5.Maintenance~Nilotinib 400mg bid/d (during 2 years, for patients without alloHCT)~6.Consider alloHCT"
988982|NCT00844194|B3|Baseline|Total|Total of all reporting groups
988983|NCT00844194|B2|Baseline|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988984|NCT00844194|B1|Baseline|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988985|NCT00844194|P2|Participant Flow|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988986|NCT00844194|P1|Participant Flow|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988987|NCT00844194|O4|Outcome|MDD+ Non-Responder|MDD+, not treatment responder. 60mg, after week 5 120mg DLX
988988|NCT00844194|O3|Outcome|MDD- Non-Responder|MDD-, not treatment responder. 60mg, after week 5 120mg DLX
988989|NCT00844194|O2|Outcome|MDD+ Responder|MDD+, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
988990|NCT00844194|O1|Outcome|MDD- Responder|MDD-, treatment responder. 60mg Duloxetine (DLX) for 12 weeks
988991|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988992|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988993|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988994|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988995|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988996|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988997|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
988998|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
988999|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989000|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989001|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989002|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989003|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989004|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989005|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989006|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989007|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989008|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989506|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989018|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989019|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989020|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989021|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989022|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989023|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989024|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989025|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989026|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989027|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989028|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989029|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989030|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989031|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989032|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989033|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989034|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989035|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989036|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989037|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989038|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989039|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989040|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989041|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989042|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989043|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989044|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989045|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989046|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989047|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989048|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989049|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989050|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989051|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989052|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989053|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989054|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989055|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989056|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989057|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989058|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989059|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989060|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989061|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989062|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989063|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989064|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989065|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989066|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989067|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989068|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989069|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989507|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989070|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989071|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989072|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989073|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989074|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989075|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989076|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989077|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989078|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989079|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989080|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989081|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989082|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989083|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989084|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989085|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989086|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989087|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989088|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989089|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989090|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989091|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989092|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989093|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989094|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989095|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989096|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989097|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989098|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989099|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989100|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989101|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989102|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989103|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989104|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989105|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989106|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989107|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989108|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989109|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989110|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989111|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989112|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989113|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989114|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989115|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989116|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989117|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989118|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989119|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989120|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989121|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989122|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989508|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989123|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989124|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989125|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989126|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989127|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989128|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989129|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989130|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989131|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989132|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989133|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989134|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989135|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989136|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989137|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989138|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989139|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989140|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989141|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989142|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989143|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989144|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989145|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989146|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989147|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989148|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989149|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989150|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989151|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989152|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989153|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989154|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989155|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989156|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989157|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989158|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989159|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989160|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989161|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989162|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989163|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989164|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989165|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989166|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989167|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989168|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989169|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989170|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989171|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989172|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989173|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989174|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989175|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989509|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989176|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989177|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989178|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989179|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989180|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989181|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989182|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989183|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989184|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989185|NCT00844194|O2|Outcome|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989186|NCT00844194|O1|Outcome|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989187|NCT00844194|E2|Reported Event|With Major Depressive Disorder (MDD+)|Patients with diabetic polyneuropathy and depression
989188|NCT00844194|E1|Reported Event|Without Major Depressive Disorder (MDD-)|Patients with diabetic polyneuropathy and no depression
989189|NCT00844090|B3|Baseline|Total|Total of all reporting groups
989190|NCT00844090|B2|Baseline|Placebo|"placebo~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989191|NCT00844090|B1|Baseline|Methylphenidate|"methylphenidate~methylphenidate : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989192|NCT00844090|P2|Participant Flow|Placebo|"placebo~placebo only to treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989193|NCT00844090|P1|Participant Flow|Methylphenidate|"methylphenidate~methylphenidate 10mg twice daily P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989194|NCT00844090|O2|Outcome|Placebo|"placebo~Placebo tabs BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989195|NCT00844090|O1|Outcome|Methylphenidate|"methylphenidate~methylphenidate 10mg BID P.O. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989196|NCT00844090|E2|Reported Event|Placebo|"placebo~Placebo bid p.o. : treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989197|NCT00844090|E1|Reported Event|Methyphenidate|"methylphenidate~methylphenidate 10mg bid p.o.: treat apathy to improve diabetes self care behaviors thereby improving glycemic control"
989198|NCT00844051|B3|Baseline|Total|Total of all reporting groups
989199|NCT00844051|B2|Baseline|Intervention|"School-based Influenza Vaccination Program~School-based influenza vaccination program: School-based influenza vaccination program"
989200|NCT00844051|B1|Baseline|No Intervention|No school-based influenza vaccination program
989201|NCT00844051|P2|Participant Flow|Intervention|School-based Influenza Vaccination Program
989202|NCT00844051|P1|Participant Flow|No Intervention|No school-based influenza vaccination program
989203|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
989204|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
989205|NCT00844051|O2|Outcome|Intervention|School-based Influenza Vaccination Program
989206|NCT00844051|O1|Outcome|No Intervention|No school-based influenza vaccination program
989207|NCT00844051|E2|Reported Event|Intervention|School-based Influenza Vaccination Program
989208|NCT00844051|E1|Reported Event|No Intervention|No school-based influenza vaccination program
989209|NCT00843986|B3|Baseline|Total|Total of all reporting groups
989210|NCT00843986|B2|Baseline|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989211|NCT00843986|B1|Baseline|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989212|NCT00843986|P2|Participant Flow|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989213|NCT00843986|P1|Participant Flow|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989214|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989215|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989216|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989217|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989218|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989219|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989220|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989221|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989222|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989223|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989224|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989225|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989226|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989227|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989228|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989229|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989230|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989231|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989232|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989233|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989234|NCT00843986|O2|Outcome|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989235|NCT00843986|O1|Outcome|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989236|NCT00843986|E2|Reported Event|Conivaptan|20mg loading dose followed by a 20mg/ day continuous intravenous infusion for 48 hours
989237|NCT00843986|E1|Reported Event|Placebo|Matching loading dose and continuous intravenous infusion for 48 hours
989238|NCT00843843|B3|Baseline|Total|Total of all reporting groups
989239|NCT00843843|B2|Baseline|3 Hour Nap and 6 Hour Sleep, Then 9 Hour Nap|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
989240|NCT00843843|B1|Baseline|9 Hour Sleep, Then 3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
989241|NCT00843843|P2|Participant Flow|3 Hour Nap and 6 Hour Sleep (3days), Then 9 Hour Sleep (3days)|3 hour nap and 6 hour sleep (3days), then 9 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
989242|NCT00843843|P1|Participant Flow|9 Hour Sleep (3days), Then 3 Hour Nap and 6 Hour Sleep (3days)|9 hour sleep (3days), then 3 hour nap and 6 hour sleep (3days). Each 3 day intervention included a morning bright light treatment of about 5000 lux, administered while sitting at a desk.
989243|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
989244|NCT00843843|O1|Outcome|9 Hour Sleep|
989245|NCT00843843|O2|Outcome|3 Hour Nap and 6 Hour Sleep|
989246|NCT00843843|O1|Outcome|9 Hour Sleep|
989247|NCT00843843|E2|Reported Event|3 Hour Nap and 6 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
989248|NCT00843843|E1|Reported Event|9 Hour Sleep|Bright light box: Bright light of about 5000 lux, administered while sitting at a desk.
989249|NCT00843830|B1|Baseline|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
989250|NCT00843830|P1|Participant Flow|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
989251|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
989252|NCT00843830|O1|Outcome|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
989253|NCT00843830|E1|Reported Event|Treatment Arm|"tumoral irradiation: On day 1 of the study treatment, patients will begin tumoral irradiation, which will be given daily for 4 days in 6Gy fractions (days 1 through 4)~Dendritic cell vaccination: Three intra-tumoral injections of 1 ml cell suspensions of KLH- pulsed DC will be delivered percutaneously under ultrasound into a selected hepatic metastasis in the outpatient setting.~Additional cycles: Patients who meet criteria for response or stable disease (see section 9) will be eligible to receive additional cycles of treatment provided that they experienced no severe toxicity with the first series of administrations.Additional cycles will consist of a series of 3 injections of DCs into same target hepatic lesion beginning within 2 weeks of the CT scan."
989254|NCT00843778|B1|Baseline|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989325|NCT00843635|P3|Participant Flow|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
989510|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989514|NCT00843115|E1|Reported Event|Donepezil|As per physician prescription
989255|NCT00843778|P1|Participant Flow|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989256|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989257|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989258|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989259|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989260|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989261|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989262|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989263|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989264|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989265|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989266|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989319|NCT00843713|E2|Reported Event|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989267|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989268|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989269|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989270|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989271|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989272|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989273|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989274|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989275|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989276|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989277|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989278|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989320|NCT00843713|E1|Reported Event|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989279|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989280|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989281|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989282|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989283|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989284|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989285|NCT00843778|O1|Outcome|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], received respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject entered the C87080 study and was further treated with 200 mg Certolizumab Pegol every two weeks."
989286|NCT00843778|E1|Reported Event|Certolizumab Pegol|"Certolizumab Pegol: 200 mg every two weeks~Certolizumab Pegol 200 mg was administered every two weeks at the hospital by a nurse or at the patient's home done by patient (self-injection).~Subjects who flared at Week 48 or Week 52 of feeder study C87076 [NCT00674362], will receive respectively once 400 mg Certolizumab Pegol or three times 400 mg Certolizumab Pegol at two weeks interval as part of an induction phase in the C87080 study. Thereafter the subject enters the C87080 study and will be further treated with 200 mg Certolizumab Pegol every two weeks."
989287|NCT00842608|B5|Baseline|Total|Total of all reporting groups
989288|NCT00842608|B4|Baseline|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989289|NCT00842608|B3|Baseline|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
989290|NCT00842608|B2|Baseline|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989291|NCT00842608|B1|Baseline|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
989292|NCT00842608|P4|Participant Flow|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989321|NCT00843635|B4|Baseline|Total|Total of all reporting groups
989293|NCT00842608|P3|Participant Flow|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
989294|NCT00842608|P2|Participant Flow|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989295|NCT00842608|P1|Participant Flow|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
989296|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989297|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
989298|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989299|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
989300|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989301|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
989302|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989303|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
989304|NCT00842608|O4|Outcome|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989322|NCT00843635|B3|Baseline|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
989323|NCT00843635|B2|Baseline|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989305|NCT00842608|O3|Outcome|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
989306|NCT00842608|O2|Outcome|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989307|NCT00842608|O1|Outcome|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
989308|NCT00842608|E4|Reported Event|Haldol Ineligible Usual Care|"Usual Care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989309|NCT00842608|E3|Reported Event|Haldol-Ineligible Arm|"Haldol-Ineligible arm for patients with contraindications for Haldol, unresolvable prolonged QTc, history of torsades de pointes, or history of seizures.~Patients are randomized and will still receive:~reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation"
989310|NCT00842608|E2|Reported Event|Haloperidol Eligible Usual Care|"Usual care~Usual care: May include use of typical and atypical neuroleptics, benzodiazepines, and other sedatives to manage the symptoms of delirium"
989311|NCT00842608|E1|Reported Event|Haloperidol Eligible Intervention|"0.5-1mg Haloperidol Q8h for 7 days, reduced exposure to anticholinergics, reduced exposure to benzodiazepines~Reduced exposure to anticholinergics: Using the computerized support, physicians will be notified if they attempt to prescribe a patient a medication with anticholinergic properties and will be given a safe alternative to the drug.~Patients who are in the non-haldol arm will have their medical records manually reviewed by the study pharmacist as the computerized support is not set to differentiate between patients who can & cannot receive Haldol~Reduced exposure to benzodiazepines: Tapering exposure to benzodiazepines by 50% over the first 48 hours after mechanical ventilation, complete stop by discharge; no benzodiazepine orders for patients not requiring mechanical ventilation~Haloperidol: 0.5 to 1 mg haloperidol every 8 hours via oral or parenteral route for a total of seven days or until discharge from the hospital"
989312|NCT00843713|B3|Baseline|Total|Total of all reporting groups
989313|NCT00843713|B2|Baseline|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989314|NCT00843713|B1|Baseline|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989315|NCT00843713|P2|Participant Flow|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989316|NCT00843713|P1|Participant Flow|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989317|NCT00843713|O2|Outcome|Raltegravir|"For subjects assigned to the active comparator group, they will receive raltegravir at 400 mg by mouth twice daily for 24 weeks in addition to continuing to take their current HIV medication~raltegravir: For patients assigned to the raltegravir group, subjects will receive raltegravir 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989318|NCT00843713|O1|Outcome|Placebo|"For subjects assigned to the placebo group, patients will take a matching placebo pill of 400 mg by mouth twice daily for 24 weeks in addition to taking their current HIV medication~Placebo: For the patient assigned to the placebo group, subjects will take a matching placebo pill 400mg to be taken by mouth twice daily for 24 weeks in addition to taking their current HIV medication"
989324|NCT00843635|B1|Baseline|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989407|NCT00843349|P4|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate Placebo|no dietary intervention + Lanthanum Carbonate placebo
989326|NCT00843635|P2|Participant Flow|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989327|NCT00843635|P1|Participant Flow|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989328|NCT00843635|O3|Outcome|Arm C - Placebo|Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.
989329|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
989330|NCT00843635|O1|Outcome|Arm A - 10mg|Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.
989331|NCT00843635|O1|Outcome|Arm A (Tadalafil 10mg) + Arm B (Tadalafil 20mg)|All participants enrolled to the two dosing arms, Arm A (Tadalafil 10 mg) and Arm B (Tadalafil 20 mg).
989332|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
989333|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989334|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989335|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
989336|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989337|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989338|NCT00843635|O3|Outcome|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
989339|NCT00843635|O2|Outcome|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989340|NCT00843635|O1|Outcome|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989341|NCT00843635|E3|Reported Event|Arm C - Placebo|"Patients receive oral placebo once daily on days 1-20 in the absence of unacceptable toxicity.~Placebo: Given orally"
989342|NCT00843635|E2|Reported Event|Arm B - Tadalafil 20mg|"Patients will receive 20mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989343|NCT00843635|E1|Reported Event|Arm A - Tadalafil 10mg|"Patients will receive 10mg/day Tadalafil orally on days 1 - 20 in the absence of unacceptable toxicity.~Tadalafil: Given orally"
989344|NCT00843622|B3|Baseline|Total|Total of all reporting groups
989345|NCT00843622|B2|Baseline|Placebo Snus|Non-tobacco, non-nicotine placebo product
989346|NCT00843622|B1|Baseline|Active Snus|Tobacco-based, smokefree product
989347|NCT00843622|P2|Participant Flow|Placebo Snus|Non-tobacco, non-nicotine placebo product
989348|NCT00843622|P1|Participant Flow|Active Snus|Tobacco-based, smokefree product
989349|NCT00843622|O2|Outcome|Placebo Snus|Non-tobacco, non-nicotine placebo product
989350|NCT00843622|O1|Outcome|Active Snus|Tobacco-based, smokefree product
989351|NCT00843622|E2|Reported Event|Placebo Snus|Non-tobacco, non-nicotine placebo product
989352|NCT00843622|E1|Reported Event|Active Snus|Tobacco-based, smokefree product
989353|NCT00843492|B3|Baseline|Total|Total of all reporting groups
989354|NCT00843492|B2|Baseline|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989355|NCT00843492|B1|Baseline|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989356|NCT00843492|P2|Participant Flow|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989357|NCT00843492|P1|Participant Flow|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989358|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989359|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989360|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989361|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989362|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989363|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989439|NCT00843180|B2|Baseline|Control|usual care only as control arm hospital care during bone marrow transplant
989364|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989365|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989366|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989367|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989368|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989369|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989370|NCT00843492|O2|Outcome|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989371|NCT00843492|O1|Outcome|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989372|NCT00843492|E2|Reported Event|Fondaparinux|2.5 milligrams (mg) fondaparinux sodium (in 0.5 ml) or 1.5 mg fondaparinux (in 0.3 ml) (in participants with creatinine clearance between 30 and 50 ml per minute) was injected once daily subcutaneously from Day 1 until Day 45 (Visit 3)
989373|NCT00843492|E1|Reported Event|Nadroparin|2850 anti-Xa International Units (IU) nadroparin calcium (in 0.3 milliliters [ml] in disposable prefilled syringes) was injected once daily subcutaneously after randomization (Day 1) until the end of immobilization and treatment period Day 45 (Visit 3)
989374|NCT00843479|B3|Baseline|Total|Total of all reporting groups
989375|NCT00843479|B2|Baseline|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989376|NCT00843479|B1|Baseline|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989377|NCT00843479|P2|Participant Flow|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989378|NCT00843479|P1|Participant Flow|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989379|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989380|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989381|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989382|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989383|NCT00843479|O2|Outcome|Middle-age NGT|Middle-age normoglycemic subjects 35 to 50 years old
989384|NCT00843479|O1|Outcome|Elderly NGT|Normoglycemic subjects 65-80 years old
989385|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989386|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989387|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989388|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989389|NCT00843479|O2|Outcome|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989390|NCT00843479|O1|Outcome|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989391|NCT00843479|E2|Reported Event|Middle-age Normal Glucose Tolerance (NGT)|Middle-age normoglycemic subjects 35 to 50 years old.
989392|NCT00843479|E1|Reported Event|Elderly Normal Glucose Tolerance (NGT)|Normoglycemic subjects 65-80 years old
989393|NCT00843466|B3|Baseline|Total|Total of all reporting groups
989394|NCT00843466|B2|Baseline|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
989395|NCT00843466|B1|Baseline|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
989396|NCT00843466|P2|Participant Flow|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
989397|NCT00843466|P1|Participant Flow|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
989398|NCT00843466|O2|Outcome|No Treatment|The control group continued to use their current cleanser for hand washing.
989399|NCT00843466|O1|Outcome|Mild Moisturizing Hand Cleanser Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
989400|NCT00843466|E2|Reported Event|Control Group (Current Product)|The control group continued to use their current cleanser for hand washing.
989401|NCT00843466|E1|Reported Event|Test Product|The test group was provided with a test product for all hand cleansing needs during the duration of the study.
989402|NCT00843349|B5|Baseline|Total|Total of all reporting groups
989403|NCT00843349|B4|Baseline|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
989404|NCT00843349|B3|Baseline|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
989405|NCT00843349|B2|Baseline|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
989406|NCT00843349|B1|Baseline|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
989408|NCT00843349|P3|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + Lanthanum Carbonate placebo
989409|NCT00843349|P2|Participant Flow|Ad Libitum Diet-Lanthanum Carbonate|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
989410|NCT00843349|P1|Participant Flow|900 mg Phosphate Diet-Lanthanum Carbonate (LC)|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
989411|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
989412|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
989413|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
989414|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
989415|NCT00843349|O4|Outcome|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
989416|NCT00843349|O3|Outcome|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
989417|NCT00843349|O2|Outcome|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
989418|NCT00843349|O1|Outcome|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
989419|NCT00843349|E4|Reported Event|Ad Libitum Diet-LC Placebo|no dietary intervention + placebo
989420|NCT00843349|E3|Reported Event|900 mg Phosphate Diet-LC Placebo|dietary phosphorus restriction (900 mg/day of phosphorus) + placebo
989421|NCT00843349|E2|Reported Event|Ad Libitum Diet-LC|no dietary intervention + phosphorus binder (Lanthanum Carbonate)
989422|NCT00843349|E1|Reported Event|900 mg Phosphate Diet-LC|dietary phosphorus restriction (900 mg/day of phosphorus) + phosphorus binder (Lanthanum Carbonate)
989423|NCT00843310|B1|Baseline|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
989424|NCT00843310|P1|Participant Flow|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
989425|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
989426|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
989427|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
989428|NCT00843310|O1|Outcome|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
989429|NCT00843310|E1|Reported Event|ReMeDex|"Treatment phase (28 days/cycle x 6 cycles):~Lenalidomide: 10 mg/day orally on days 1-21, followed by 7 days of rest. Melphalan: 4 mg/m2 daily on days 1-4. Dexamethasone: 40 mg daily on days 1, 8, 15 and 22.~Maintenance Phase (for subjects who achieve partial response or better at the end of the treatment phase):~lenalidomide: 10 mg/day orally on days 1-21 followed by 7 days of rest (28 days/cycle) for a maximum of 24 cycles."
989430|NCT00843284|B1|Baseline|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989431|NCT00843284|P1|Participant Flow|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989432|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989433|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989434|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989435|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989436|NCT00843284|O1|Outcome|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989437|NCT00843284|E1|Reported Event|Pregabalin (150 mg to 600 mg Per Day in 2 to 3 Divided Doses)|275 subjects received pregabalin alone while 416 subjects received pregabalin in combination with another neuropathic pain medication.
989438|NCT00843180|B3|Baseline|Total|Total of all reporting groups
989441|NCT00843180|P2|Participant Flow|Control|usual care only as control arm hospital care during bone marrow transplant
989442|NCT00843180|P1|Participant Flow|Massage|massage and acupressure up to 3x/week for entire hospital stay
989443|NCT00843180|O2|Outcome|Control|
989444|NCT00843180|O1|Outcome|Massage|
989445|NCT00843180|O2|Outcome|Control|
989446|NCT00843180|O1|Outcome|Massage|
989447|NCT00843180|O2|Outcome|Control|
989448|NCT00843180|O1|Outcome|Massage|
989449|NCT00843180|O2|Outcome|Control|
989450|NCT00843180|O1|Outcome|Massage|
989451|NCT00843180|E2|Reported Event|Control|usual care only as control arm hospital care during bone marrow transplant
989452|NCT00843180|E1|Reported Event|Massage|massage and acupressure up to 3x/week for entire hospital stay
989453|NCT00843167|B3|Baseline|Total|Total of all reporting groups
989454|NCT00843167|B2|Baseline|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
989455|NCT00843167|B1|Baseline|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
989456|NCT00843167|P2|Participant Flow|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
989457|NCT00843167|P1|Participant Flow|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
989458|NCT00843167|O2|Outcome|Treatment|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
989459|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
989460|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
989461|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
989462|NCT00843167|O3|Outcome|Invasive Ductal Carcinoma Tissue; Ki-67|Sulforaphane Supplement= 7, Placebo= 6
989463|NCT00843167|O2|Outcome|DCIS Tissue; Ki-67|Sulforaphane Supplement= 6, Placebo = 13
989464|NCT00843167|O1|Outcome|Benign Tissue; Ki-67|Sulforaphane Supplement = 23, Placebo = 25
989465|NCT00843167|O2|Outcome|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
989466|NCT00843167|O1|Outcome|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
989467|NCT00843167|E2|Reported Event|Placebo|"Patients receive oral placebo supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~placebo: Given orally"
989468|NCT00843167|E1|Reported Event|Sulforaphane Supplement|"Patients receive oral broccoli sprout extract supplementation three times daily for 2-8 weeks in the absence of unacceptable toxicity.~broccoli sprout extract: Given orally"
989469|NCT00843115|B1|Baseline|Donepezil|As per physician prescription
989470|NCT00843115|P1|Participant Flow|Donepezil|As per physician prescription
989471|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989472|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989473|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989474|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989475|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989476|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989477|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989478|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989479|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989480|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989481|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989482|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989483|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989484|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989485|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989486|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989487|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989488|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989489|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989490|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989491|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989492|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989493|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989494|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989495|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989496|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989497|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989498|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989499|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989500|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989501|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989502|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989503|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989504|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989505|NCT00843115|O1|Outcome|Donepezil|As per physician prescription
989515|NCT00843050|B1|Baseline|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
989516|NCT00843050|P1|Participant Flow|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
989517|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
989518|NCT00843050|O1|Outcome|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
989519|NCT00843050|O1|Outcome|P276-00|P276-00: All patients received P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there was progression of disease or unacceptable toxicity
989520|NCT00843050|E1|Reported Event|P276-00|P276-00: All patients will receive P276-00 185 mg/m2/day as intravenous infusion over 30 minutes in 200 ml of 5% dextrose from day 1 to day 5 in each 21 days cycle for minimum 6 and maximum 12 cycles or until there is progression of disease or unacceptable toxicity
989521|NCT00843024|B5|Baseline|Total|Total of all reporting groups
989522|NCT00843024|B4|Baseline|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989523|NCT00843024|B3|Baseline|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989524|NCT00843024|B2|Baseline|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989525|NCT00843024|B1|Baseline|Placebo|A single matching placebo tablet taken within a 12-week period
989526|NCT00843024|P6|Participant Flow|Sumatriptan 85 mg/ Naproxen 500 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989527|NCT00843024|P5|Participant Flow|Sumatriptan 30 mg/ Naproxen 180 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989528|NCT00843024|P4|Participant Flow|Sumatriptan 10 mg/ Naproxen 60 mg|After completing the single-blind phase, participants received a single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989529|NCT00843024|P3|Participant Flow|Placebo|After completing the single-blind phase, participants received a single matching placebo tablet taken within a 12-week period
989530|NCT00843024|P2|Participant Flow|15 to 17 Years Age Group: Single-blind Phase|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
989531|NCT00843024|P1|Participant Flow|12 to 14 Years Age Group: Single-blind Phase|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of single-blind placebo within a 12-week period. After completion of the run-in phase, participants were randomized to one of four double-blind treatment groups.
989532|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989533|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989534|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989535|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989536|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989537|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989538|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989539|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989540|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989541|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989542|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989543|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989587|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
990056|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
989544|NCT00843024|O2|Outcome|15 to 17 Years Age Group|Participants 15 to 17 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989545|NCT00843024|O1|Outcome|12 to 14 Years Age Group|Participants 12 to 14 years old treated one moderate to severe migraine attack with one tablet of double-blind treatment (placebo or one of the three sumatriptan/naproxen combination groups) within a 12-week period
989546|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989547|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989548|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989549|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989550|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989551|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989552|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989553|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989554|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989555|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989556|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989557|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989558|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989559|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989560|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989561|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989562|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989563|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989564|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989565|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989566|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989567|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989568|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989569|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989570|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989571|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989572|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989573|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989574|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989575|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989576|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989577|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989578|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989579|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989580|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989581|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989582|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989583|NCT00843024|O3|Outcome|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989584|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989585|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989586|NCT00843024|O4|Outcome|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989588|NCT00843024|O2|Outcome|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989589|NCT00843024|O1|Outcome|Placebo|A single matching placebo tablet taken within a 12-week period
989590|NCT00843024|E5|Reported Event|Single-blind Run-In Phase Placebo|One tablet of single-blind placebo taken during the Run-In Phase
989591|NCT00843024|E4|Reported Event|Sumatriptan 85 mg/ Naproxen 500 mg|A single combination tablet of sumatriptan 85 mg and naproxen sodium 500 mg taken within a 12-week period
989592|NCT00843024|E3|Reported Event|Sumatriptan 30 mg/ Naproxen 180 mg|A single combination tablet of sumatriptan 30 mg and naproxen sodium 180 mg taken within a 12-week period
989593|NCT00843024|E2|Reported Event|Sumatriptan 10 mg/ Naproxen 60 mg|A single combination tablet of sumatriptan 10 milligrams (mg) and naproxen sodium 60 mg taken within a 12-week period
989594|NCT00843024|E1|Reported Event|Placebo|A single matching double-blind placebo tablet taken within a 12-week period
989595|NCT00842985|B1|Baseline|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
989596|NCT00842985|P1|Participant Flow|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
989597|NCT00842985|O4|Outcome|Placebo+Placebo|Session where placebo THC and Placebo Modafinil were given.
989598|NCT00842985|O3|Outcome|Pla+Modafinil|Session where Placebo THC and Modafinil were given
989599|NCT00842985|O2|Outcome|THC+Placebo|Session where TCH and Placebo Modafinil were given
989600|NCT00842985|O1|Outcome|THC+Modafinil|Session where THC+Modafinil was given.
989601|NCT00842985|E1|Reported Event|All Participants|"There were 4 sessions given in a counterbalanced order: Dronabinol+Modafinil, Dronabinol+Placebo, Placebo+Modafinil, Placebo+Placebo.~Not all participants received the interventions in the same order."
989602|NCT00842946|B3|Baseline|Total|Total of all reporting groups
989603|NCT00842946|B2|Baseline|Habituation|Behavioral exposure within the context of habituation.
989604|NCT00842946|B1|Baseline|Acceptance|Behavioral exposure within the context of psychological acceptance.
989605|NCT00842946|P2|Participant Flow|Habituation|Behavioral exposure within the context of habituation.
989606|NCT00842946|P1|Participant Flow|Acceptance|Behavioral exposure within the context of psychological acceptance.
989607|NCT00842946|O2|Outcome|Habituation|Behavioral exposure within the context of habituation.
989608|NCT00842946|O1|Outcome|Acceptance|Behavioral exposure within the context of psychological acceptance.
989609|NCT00842946|E2|Reported Event|Habituation|Behavioral exposure within the context of habituation.
989610|NCT00842946|E1|Reported Event|Acceptance|Behavioral exposure within the context of psychological acceptance.
989611|NCT00842829|B3|Baseline|Total|Total of all reporting groups
989612|NCT00842829|B2|Baseline|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989613|NCT00842829|B1|Baseline|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989614|NCT00842829|P3|Participant Flow|FBT - Treatment and Continuation Periods|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days). The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
989615|NCT00842829|P2|Participant Flow|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989616|NCT00842829|P1|Participant Flow|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989617|NCT00842829|O4|Outcome|FBT - Continuation Period|The length of the Continuation Period (when applicable) varied from country to country, up to until FBT was commercially available in that country.
989618|NCT00842829|O3|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989619|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989620|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989621|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989622|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989623|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989624|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989863|NCT00841971|B1|Baseline|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
989625|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989626|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989627|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989628|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989629|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989630|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989631|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989632|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989633|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989634|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989635|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989636|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989637|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989638|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989639|NCT00842829|O2|Outcome|60 Minutes|Participant assessments of medication performance 60 minutes after dosing during the Treatment Period.
989640|NCT00842829|O1|Outcome|30 Minutes|Participant assessments of medication performance 30 minutes after dosing during the Treatment Period.
989641|NCT00842829|O2|Outcome|During Treatment Period|The treatment period included participants who identified an effective dose during the earlier study period and used that dose for BTP episodes during the Treatment Period.
989642|NCT00842829|O1|Outcome|During Titration Period|The titration period consisted of up to 7 days of treatment in which participants used increasing dosage of study drug in order to identify the effective dose for their breakthrough pain episodes.
989643|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989644|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989645|NCT00842829|O1|Outcome|FBT - Treatment Period|Participants who reached an effective dose entered the Open-label Treatment Period, whose length depended on how long was needed to treat up to 8 episodes of breakthrough pain (BTP) with FBT (maximum of 8 days).
989646|NCT00842829|O2|Outcome|FBT 200 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 200 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989647|NCT00842829|O1|Outcome|FBT 100 Mcg - Dose Titration Period|During the Titration Period, participants took fentanyl buccal tables (FBT) with a starting dose of 100 mcg until they reached an effective dose, with a maximum dose of 800 mcg and a maximum timeframe of 7 days.
989648|NCT00842829|E1|Reported Event|FBT - All Doses and Study Periods|Participants took fentanyl buccal tables (FBT) with doses between 100-800 mcg
989649|NCT00842751|B1|Baseline|All Study Participants|
989650|NCT00842751|P1|Participant Flow|Acyline + Testosterone Undecanoate + Placebo Finasteride|Acyline 300 mcg/kg +Testosterone Undecanoate 200 mg, BID orally + placebo finasteride
989651|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
989652|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
989653|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, twice daily (BID) orally + placebo finasteride
989654|NCT00842751|O3|Outcome|Acyline + Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 1mg finasteride
989655|NCT00842751|O2|Outcome|Acyline + Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + 0.5mg finasteride
989656|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg subcutaneous (SC) +Testosterone Undecanoate 200 mg, BID orally + Placebo finasteride
989657|NCT00842751|O3|Outcome|Acyline +Testosterone Undecanoate + 1mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 1 mg, BID orally
989658|NCT00842751|O2|Outcome|Acyline +Testosterone Undecanoate + 0.5mg Finasteride|Acyline 300 mcg/kg SC + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5 mg, BID orally
989659|NCT00842751|O1|Outcome|Acyline +Testosterone Undecanoate + Placebo|Acyline 300 mcg/kg SC +Testosterone Undecanoate 200 mg, BID orally + Placebo Finasteride
989660|NCT00842751|E3|Reported Event|Third Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily orally + Finasteride 1mg, twice a day, orally
989661|NCT00842751|E2|Reported Event|Second Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, BID orally + Finasteride 0.5mg, twice a day, orally
989662|NCT00842751|E1|Reported Event|First Intervention|Acyline 300mcg/kg subcutaneous on days 1, 15 & 29 + Testosterone Undecanoate 200 mg, twice daily, orally + Finasteride placebo, twice daily, orally
989663|NCT00842712|B8|Baseline|Total|Total of all reporting groups
989664|NCT00842712|B7|Baseline|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989665|NCT00842712|B6|Baseline|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989666|NCT00842712|B5|Baseline|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989667|NCT00842712|B4|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989668|NCT00842712|B3|Baseline|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989669|NCT00842712|B2|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989670|NCT00842712|B1|Baseline|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989671|NCT00842712|P7|Participant Flow|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989672|NCT00842712|P6|Participant Flow|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989673|NCT00842712|P5|Participant Flow|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989674|NCT00842712|P4|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989675|NCT00842712|P3|Participant Flow|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989676|NCT00842712|P2|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989677|NCT00842712|P1|Participant Flow|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989678|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989679|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989680|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989681|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989682|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989683|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989684|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989696|NCT00842712|O1|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989727|NCT00842361|P1|Participant Flow|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989685|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989686|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989687|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989688|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989689|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989690|NCT00842712|O3|Outcome|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989691|NCT00842712|O2|Outcome|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989692|NCT00842712|O1|Outcome|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989693|NCT00842712|O4|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989694|NCT00842712|O3|Outcome|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989695|NCT00842712|O2|Outcome|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989756|NCT00842348|E1|Reported Event|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
989697|NCT00842712|E7|Reported Event|Randomized Part: Cetuximab + Chemotherapy|Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989698|NCT00842712|E6|Reported Event|Randomized Part: Cil (Twice Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1, 4, 8, 11, 15, and 18 of each 3-week cycle followed by once weekly administration after end of chemotherapy + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989699|NCT00842712|E5|Reported Event|Randomized Part: Cil (Once Weekly) + Cetuximab + Chemotherapy|Cil 2000 mg intravenous infusion once weekly over 1 hour on Days 1, 8 and 15 of each 3-week cycle + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 of Cycle 1 followed by cetuximab 250 mg/m^2 intravenous infusion over 1 hour once weekly on Days 8 and 15 of Cycle 1 and Days 1, 8, and 15 of all subsequent cycles until progressive disease, death, unacceptable toxicity, or consent withdrawal. Chemotherapy (Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 or Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 of each 3-week cycle) was administered along with Cil and cetuximab as per Investigator's discretion up to a maximum of 6 cycles.
989700|NCT00842712|E4|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Vin|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vin 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989701|NCT00842712|E3|Reported Event|Safety run-in Part: Cil (2000 mg) + Cetuximab + Cis + Gem|Cil 2000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 75 mg/m^2 intravenous infusion on Day 1 + Gem 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989702|NCT00842712|E2|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Vin|Cil 1000 mg intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 mg/m^2 intravenous infusion over 2 hours on Day 1 + Cis 80 mg/m^2 intravenous infusion on Day 1 + Vinorelbine (Vin) 25 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989703|NCT00842712|E1|Reported Event|Safety run-in Part: Cil (1000 mg) + Cetuximab + Cis + Gem|Cilengitide (Cil) 1000 milligram (mg) intravenous infusion twice weekly over 1 hour on Days 1 and 4 + Cetuximab 400 milligram per square meter (mg/m^2) intravenous infusion over 2 hours on Day 1 + Cisplatin (Cis) 75 mg/m^2 intravenous infusion on Day 1 + Gemcitabine (Gem) 1250 mg/m^2 intravenous infusion on Days 1 and 8 for 3 weeks.
989704|NCT00842543|B5|Baseline|Total|Total of all reporting groups
989705|NCT00842543|B4|Baseline|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
989706|NCT00842543|B3|Baseline|Overweight Placebo|Overweight Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
989707|NCT00842543|B2|Baseline|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
989708|NCT00842543|B1|Baseline|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
989709|NCT00842543|P4|Participant Flow|Lean Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months
989710|NCT00842543|P3|Participant Flow|Overweight Placebo|Lean Boys prior to receiving Placebo, 1 capsule, twice a day, for 6 months.
989711|NCT00842543|P2|Participant Flow|Lean FVJC|Lean Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
989712|NCT00842543|P1|Participant Flow|Overweight FVJC|Overweight Boys prior to receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
989713|NCT00842543|O4|Outcome|Lean Placebo|
989714|NCT00842543|O3|Outcome|Overweight Placebo|Reesults displayed for overweight boys who received 6 months of Placebo intervention
989715|NCT00842543|O2|Outcome|Lean FVJC|
989716|NCT00842543|O1|Outcome|Overweight FVJC|Results displayed for overweight boys who received 6 months of FVJC intervention
989717|NCT00842543|O2|Outcome|Lean|Lean boys prior to receiving intervention.
989718|NCT00842543|O1|Outcome|Overweight|Overweight boys prior to receiving intervention.
989719|NCT00842543|E4|Reported Event|Lean Placebo|Lean Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
989720|NCT00842543|E3|Reported Event|Overweight Placebo|Overweight Boys receiving Placebo, 1 capsule, twice a day, for 6 months.
989721|NCT00842543|E2|Reported Event|Lean FVJC|Lean Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
989722|NCT00842543|E1|Reported Event|Overweight FVJC|Overweight Boys receiving Fruit and Vegetable Juice Concentrate (FVJC), 1 capsule, twice a day, for 6 months.
989723|NCT00842361|B3|Baseline|Total|Total of all reporting groups
989724|NCT00842361|B2|Baseline|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989725|NCT00842361|B1|Baseline|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989726|NCT00842361|P2|Participant Flow|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989862|NCT00841971|B2|Baseline|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
989728|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989729|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989730|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989731|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989732|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989733|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989734|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989735|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989736|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989737|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989738|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989739|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989740|NCT00842361|O2|Outcome|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989741|NCT00842361|O1|Outcome|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989742|NCT00842361|E2|Reported Event|Mix30|Biphasic insulin aspart (IAsp) 30 (Mix30) (i.e., 30% IAsp and 70% protamine-crystallised IAsp) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted.
989743|NCT00842361|E1|Reported Event|SIAC|Soluble insulin basal analogue combination (SIAC, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart [IAsp], 600 nmol/ml) was given subcutaneously twice daily immediately before breakfast and dinner for 6 weeks. Insulin doses were individually adjusted
989744|NCT00842348|B3|Baseline|Total|Total of all reporting groups
989745|NCT00842348|B2|Baseline|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
989746|NCT00842348|B1|Baseline|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
989747|NCT00842348|P2|Participant Flow|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
989748|NCT00842348|P1|Participant Flow|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding double blind (DB) study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
989749|NCT00842348|O2|Outcome|Placebo - Randomised Treatment in Study 726|All patients randomised to placebo in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
989750|NCT00842348|O1|Outcome|Lanreotide Autogel - Randomised Treatment in Study 726|All patients randomised to lanreotide 120 mg (Autogel formulation) in the original protocol Study 726 (regardless of whether they continued into the extension Study 729).
989751|NCT00842348|O3|Outcome|Total|All patients treated with Lanreotide 120 mg (Autogel formulation) in the open label study.
989752|NCT00842348|O2|Outcome|Placebo|Patients who received placebo in the preceding double DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
989753|NCT00842348|O1|Outcome|Lanreotide Autogel|Patients who received lanreotide 120 mg (Autogel formulation) in the preceding DB study (Study 2-55-52030-726) and who continued to receive lanreotide 120 mg (Autogel formulation) in the open label study.
989754|NCT00842348|E3|Reported Event|Total|All patients treated with lanreotide 120 mg (Autogel formulation) in the open label study.
989755|NCT00842348|E2|Reported Event|Placebo|Patients who received placebo in the preceding DB study (Study 2-55-52030-726) and who received lanreotide 120 mg (Autogel formulation) in the open label study.
989864|NCT00841971|P2|Participant Flow|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
989757|NCT00842335|B1|Baseline|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
989758|NCT00842335|P1|Participant Flow|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
989759|NCT00842335|O1|Outcome|All Subjects|
989760|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
989761|NCT00842335|O1|Outcome|All Subjects|"The starting dose of JI-101 for patients in the first cohort was 100 mg QD. All patients took JI-101 without food on Day 0, with a high fat meal on Day 2, and with a regular diet on Day 3 onwards. Patients in the first three cohorts were dosed QD. Based on PK characteristics observed from the first eight patients (Cohort 1, Cohort 2, and Cohort 3), subsequent cohorts were dosed BID.~After the first eight patients, the combined PK profiles of the enrolled patients were studied. These assessments indicated that the PK profile for JI-101 supported BID dosing. Therefore, BID dosing was administered to patients who enrolled in the study following the effective date of Protocol"
989762|NCT00842335|O1|Outcome|JI-101|JI-101 : JI-101, 50 mg capsules, will be administered daily for up to 112 days (four 28-day cycles); treatment may be extended if, in the opinion of the investigator, a patient has tolerated the treatment and appears to be benefitting from receiving study medication
989763|NCT00842335|E1|Reported Event|JI-101|Maximum tolerated dose
989764|NCT00842257|B1|Baseline|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
989765|NCT00842257|P1|Participant Flow|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
989766|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
989767|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
989768|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
989769|NCT00842257|O1|Outcome|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
989770|NCT00842257|E1|Reported Event|Panitumumab|Panitumumab administered by a central line infusion over 1 hour 15 minutes on days 1 and 15 of each 4 week cycle. The starting panitumumab dose is 6 mg/kg, the total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose is calculated based on the subject's actual body weight at each visit. Panitumumab is diluted in a minimum of 100 mL of pyrogen-free 0.9% sodium chloride solution. The maximum concentration of the diluted solution to be infused should not exceed 10 mg/mL.
989771|NCT00842244|B1|Baseline|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989772|NCT00842244|P1|Participant Flow|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
990054|NCT00841321|P1|Participant Flow|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
989773|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989774|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989775|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989776|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in Pharmacokinetic (PK) expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989777|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989778|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989779|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989780|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989781|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989782|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989783|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989784|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989785|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989786|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (PK Expansion Cohort)|Participants enrolled in PK expansion cohort at MTD received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989787|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989788|NCT00842244|O1|Outcome|Axitinib + Capecitabine + Cisplatin (MTD Determination)|Axitinib (AG-013736) 5 mg tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989789|NCT00842244|E1|Reported Event|Axitinib + Capecitabine + Cisplatin|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily in cycles of 21 days, capecitabine 1000 mg per square meter (mg/m^2) tablet orally twice daily from Day 1 to 14 of each cycle and cisplatin 80 mg/m^2 infusion over 2 hours (hrs) on Day 1 of each cycle, in cycles of 21 days. Participants enrolled in pharmacokinetic (PK) expansion cohort at maximum tolerated dose (MTD) received axitinib (AG-013736) 5 mg orally twice daily starting from Day -3 to Day 18 in Cycle 1 (21 days cycle) and thereafter axitinib (AG-013736) 5 mg orally twice daily starting from Cycle 2 Day 2, capecitabine 1000 mg/m^2 tablet orally twice daily from Day 1 to 14 and cisplatin 80 mg/m^2 infusion over 2 hrs on Day 1 of each cycle, in cycles of 21 days.
989790|NCT00842231|B1|Baseline|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
989791|NCT00842231|P1|Participant Flow|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
989792|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
989793|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
989794|NCT00842231|O1|Outcome|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
989795|NCT00842231|E1|Reported Event|Visual Performance Measures|Collection of visual performance measures in subjects with low levels of astigmatism.
989796|NCT00842153|B3|Baseline|Total|Total of all reporting groups
989797|NCT00842153|B2|Baseline|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989798|NCT00842153|B1|Baseline|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989799|NCT00842153|P2|Participant Flow|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989800|NCT00842153|P1|Participant Flow|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989801|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989802|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989803|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989804|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989805|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989806|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989807|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989808|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989809|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989810|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989811|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989812|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989813|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989814|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989815|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989816|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989817|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989818|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989819|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989820|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989821|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989822|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989823|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989824|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989825|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989826|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989827|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989828|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989829|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989830|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989831|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989832|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989833|NCT00842153|O2|Outcome|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989834|NCT00842153|O1|Outcome|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989835|NCT00842153|E2|Reported Event|Vehicle Foam|Vehicle foam without the active ingredient clobestasol propionate, applied BD for four weeks to the affected area on the scalp and body
989836|NCT00842153|E1|Reported Event|Olux-E Foam|Olux-E foam containing 0.05% clobetasol propionate, applied twice daily (morning and evening [BD]) for four weeks to the affected area on the scalp and body
989837|NCT00842075|B3|Baseline|Total|Total of all reporting groups
989838|NCT00842075|B2|Baseline|2 Usual Regimen|Usual bolus insulin dose at each meal
989839|NCT00842075|B1|Baseline|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
989840|NCT00842075|P2|Participant Flow|2 Usual Regimen|Usual bolus insulin dose at each meal
989841|NCT00842075|P1|Participant Flow|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
989842|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
989843|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
989844|NCT00842075|O2|Outcome|2 Usual Regimen|Usual bolus insulin dose at each meal
989845|NCT00842075|O1|Outcome|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
989846|NCT00842075|E2|Reported Event|2 Usual Regimen|Usual bolus insulin dose at each meal
989847|NCT00842075|E1|Reported Event|1 Symlin|Subcutaneous injection of pramlintide prior to each meal with reduction of mealtime bolus insulin
989848|NCT00842023|B3|Baseline|Total|Total of all reporting groups
989849|NCT00842023|B2|Baseline|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
989850|NCT00842023|B1|Baseline|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
989851|NCT00842023|P2|Participant Flow|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
989852|NCT00842023|P1|Participant Flow|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
989853|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
989854|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
989855|NCT00842023|O2|Outcome|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
989856|NCT00842023|O1|Outcome|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
989857|NCT00842023|O2|Outcome|Nitroglycerin|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment
989858|NCT00842023|O1|Outcome|Nesiritide|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
989859|NCT00842023|E2|Reported Event|Nitroglycerin Infusion|10 mcg/min initial starting dose titrated every 5-10 minutes until symptom relief, SBP<or= 90 mm Hg, or up to a maximum rate of 200 mcg/min plus standard treatment.
989860|NCT00842023|E1|Reported Event|Nesiritide Infusion|2 mcg/kg bolus (optional) followed by 0.01 mcg/kg/min infusion for 48 hours.
989861|NCT00841971|B3|Baseline|Total|Total of all reporting groups
989865|NCT00841971|P1|Participant Flow|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
989866|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
989867|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
989868|NCT00841971|O2|Outcome|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
989869|NCT00841971|O1|Outcome|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
989870|NCT00841971|E2|Reported Event|Fluconazole|"anti-fungal agent~Fluconazole: 400 mg IV for 21 days"
989871|NCT00841971|E1|Reported Event|Anidulafungin|"anti-fungal agent~Anidulafungin: 200 mg IV loading dose followed by 100 mg qd for 21 days"
989872|NCT00841906|B3|Baseline|Total|Total of all reporting groups
989873|NCT00841906|B2|Baseline|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989874|NCT00841906|B1|Baseline|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989875|NCT00841906|P2|Participant Flow|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989876|NCT00841906|P1|Participant Flow|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989877|NCT00841906|O2|Outcome|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989878|NCT00841906|O1|Outcome|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989879|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
989880|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
989881|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
989882|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
989883|NCT00841906|O2|Outcome|Alice PDx|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
989884|NCT00841906|O1|Outcome|Alice 5 System|All participants in the lab night portion of the study will wear an Alice 5 System and an Alice PDx for comparison of the two devices.
989929|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989930|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989885|NCT00841906|E2|Reported Event|Alice PDx With Written and Verbal Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with written and verbal instructions: Participants will be provided instruction by a trained sleep professional on the set up of the Alice PDx device. They will then be asked to follow the instructions for the Alice PDx device, if necessary, and undergo a sleep study in their home. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989886|NCT00841906|E1|Reported Event|Alice PDx With Only Written Instructions|"Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device.~Alice PDx with only written instructions: Participants will be asked to follow the Alice PDx user instructions to apply basic leads and sensors and undergo a sleep study in their home. Participants will receive little or no instruction concerning the set up of the Alice PDx device. After the Alice PDx home study has proven successful, participants will return to the sleep center to undergo a second sleep study, the Lab Night, in which simultaneous monitoring with the Alice PDx and Alice 5 will be performed."
989887|NCT00841815|B3|Baseline|Total|Total of all reporting groups
989888|NCT00841815|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
989889|NCT00841815|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
989890|NCT00841815|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
989891|NCT00841815|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference) dosed in second period
989892|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
989893|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
989894|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
989895|NCT00841815|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
989896|NCT00841815|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
989897|NCT00841815|O1|Outcome|Amlodipine Besylate|Amlodipine Besylate 10 mg tablet (test) dosed in either period
989898|NCT00841776|B3|Baseline|Total|Total of all reporting groups
989899|NCT00841776|B2|Baseline|Ziana|Clindamycin and topical tretinoin gel
989900|NCT00841776|B1|Baseline|Duac|Clindamycin and benzoyl peroxide topical gel
989901|NCT00841776|P2|Participant Flow|Ziana|Clindamycin and topical tretinoin gel
989902|NCT00841776|P1|Participant Flow|Duac|Clindamycin and benzoyl peroxide topical gel
989903|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
989904|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
989905|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
989906|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
989907|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
989908|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
989909|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
989910|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
989911|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
989912|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
989913|NCT00841776|O2|Outcome|Ziana|Clindamycin and topical tretinoin gel
989914|NCT00841776|O1|Outcome|Duac|Clindamycin and benzoyl peroxide topical gel
989915|NCT00841776|E2|Reported Event|Ziana|Clindamycin and topical tretinoin gel
989916|NCT00841776|E1|Reported Event|Duac|Clindamycin and benzoyl peroxide topical gel
989917|NCT00841763|B3|Baseline|Total|Total of all reporting groups
989918|NCT00841763|B2|Baseline|PL+ aTIV|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
989919|NCT00841763|B1|Baseline|TIV + aH5N1|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1).
989920|NCT00841763|P4|Participant Flow|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
989921|NCT00841763|P3|Participant Flow|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989922|NCT00841763|P2|Participant Flow|PL+ aTIV (18 to 60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
989923|NCT00841763|P1|Participant Flow|TIV + aH5N1 (18 to 60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989924|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989925|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989926|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989927|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989928|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
990051|NCT00841321|B2|Baseline|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
989931|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989932|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989933|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989934|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989935|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers ≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989936|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989937|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989938|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989939|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60yrs) MN Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989940|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989941|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989942|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989943|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989944|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989945|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989946|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989947|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989948|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989949|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989950|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989951|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989952|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989953|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers|First dose of the non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of the adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989954|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Areas ≥25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989955|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Areas ≥ 25mm2|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989956|NCT00841763|O4|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) MN Titers ≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989957|NCT00841763|O3|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) MN Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989958|NCT00841763|O2|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) HI Titers≥ 40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989959|NCT00841763|O1|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) HI Titers≥40|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1).
989960|NCT00841763|O6|Outcome|eTIV_a + MF59-eH5N1 (>60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989961|NCT00841763|O5|Outcome|eTIV_a + MF59-eH5N1 (18-60 Yrs) SRH Assay|First dose of non-adjuvanted seasonal trivalent influenza vaccine(eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989962|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
990052|NCT00841321|B1|Baseline|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
989963|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989964|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989965|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989966|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989967|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989968|NCT00841763|O4|Outcome|TIV + aH5N1 (>60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989969|NCT00841763|O3|Outcome|TIV + aH5N1 (18-60 Yrs) MN Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989970|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989971|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs) HI Assay|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989972|NCT00841763|O4|Outcome|PL + aTIV (>60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
989973|NCT00841763|O3|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989974|NCT00841763|O2|Outcome|PL+ aTIV (18-60 Yrs)|First dose of placebo (PL) followed by two doses of influenza virus vaccine (aTIV)
989975|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989976|NCT00841763|O2|Outcome|TIV + aH5N1 (>60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989977|NCT00841763|O1|Outcome|TIV + aH5N1 (18-60 Yrs)|First dose of trivalent influenza vaccine (TIV) followed by two doses of adjuvanted monovalent influenza virus vaccine (aH5N1)
989978|NCT00841763|E4|Reported Event|PL+MF59-eTIV (>60yrs)|First dose of placebo (PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
989979|NCT00841763|E3|Reported Event|eTIV_a + MF59-eH5N1 (>60 Yrs)|First dose of non adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 influenza vaccine (MF59-eH5N1)
989980|NCT00841763|E2|Reported Event|PL+MF59-eTIV (18-60yrs)|First dose of placebo(PL) followed by two doses of adjuvanted seasonal trivalent influenza vaccine (MF59-eTIV)
989981|NCT00841763|E1|Reported Event|eTIV_a + MF59-eH5N1 (18-60 Yrs)|First dose of non-adjuvanted seasonal trivalent influenza vaccine (eTIV_a) followed by two doses of adjuvanted pandemic H5N1 vaccine (MF59-eH5N1)
989982|NCT00841698|B3|Baseline|Total|Total of all reporting groups
989983|NCT00841698|B2|Baseline|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
989984|NCT00841698|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
989985|NCT00841698|P2|Participant Flow|Paxil® (Reference First)|Paxil 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
989986|NCT00841698|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
989987|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
989988|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
989989|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
989990|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
989991|NCT00841698|O2|Outcome|Paxil®|Paxil 40 mg Tablet (reference) dosed in either period
989992|NCT00841698|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
989993|NCT00841672|B3|Baseline|Total|Total of all reporting groups
989994|NCT00841672|B2|Baseline|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
989995|NCT00841672|B1|Baseline|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
989996|NCT00841672|P2|Participant Flow|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
989997|NCT00841672|P1|Participant Flow|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
989998|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
989999|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
990000|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
990055|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
990001|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
990002|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
990003|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
990004|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
990005|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
990006|NCT00841672|O2|Outcome|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
990007|NCT00841672|O1|Outcome|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
990008|NCT00841672|E2|Reported Event|Amlodipine 10 mg Capsule|Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
990009|NCT00841672|E1|Reported Event|Aliskiren/Amlodipine 300/10 mg Tablet|Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
990010|NCT00841659|B3|Baseline|Total|Total of all reporting groups
990011|NCT00841659|B2|Baseline|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
990012|NCT00841659|B1|Baseline|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
990013|NCT00841659|P2|Participant Flow|Paxil® (Reference) First|Paxil® 40 mg Tablet (reference) dosed in first period followed by Paroxetine HCl 40 mg Tablet (test) dosed in second period
990014|NCT00841659|P1|Participant Flow|Paroxetine (Test) First|Paroxetine HCl 40 mg Tablet (test) dosed in first period followed by Paxil® 40 mg Tablet (reference) dosed in second period
990015|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
990016|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
990017|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
990018|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
990019|NCT00841659|O2|Outcome|Paxil®|Paxil® 40 mg Tablet (reference) dosed in either period
990020|NCT00841659|O1|Outcome|Paroxetine|Paroxetine HCl 40 mg Tablet (test) dosed in either period
990021|NCT00841555|B4|Baseline|Total|Total of all reporting groups
990022|NCT00841555|B3|Baseline|Dose Level 3|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990023|NCT00841555|B2|Baseline|Dose Level 2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990024|NCT00841555|B1|Baseline|Dose Level 1|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990025|NCT00841555|P3|Participant Flow|Dose Level 3: 75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990026|NCT00841555|P2|Participant Flow|Dose Level 2: 65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990053|NCT00841321|P2|Participant Flow|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
990027|NCT00841555|P1|Participant Flow|Dose Level 1: 50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990028|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990029|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990030|NCT00841555|O1|Outcome|Hypofractionation Radiotherapy+Temozolomide|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990031|NCT00841555|E3|Reported Event|75 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 3: 75 mg/m2 over the entire 5 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990032|NCT00841555|E2|Reported Event|65 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 2: 65 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990033|NCT00841555|E1|Reported Event|50 mg/m2|"Patients will receive temozolomide PO daily for 5 weeks. Beginning week 1 after initiation of temozolomide therapy, patients undergo HIMRT times a week for a total of 15 fractions.~temozolomide: Chemotherapy will be given for 5 weeks; it will start 1 week before Radiotherapy, will continue for the 3 weeks of Radiotherapy, and will continue for 1 week post-Radiotherapy.~Dose Level 1: 50 mg/m2 x first 4 weeks/75 mg/m2 x last 1 weeks of treatment~Hypofractionated radiation therapy: Patients will undergo HIMRT~Intensity-modulated radiation therapy: Patients undergo HIMRT"
990034|NCT00841542|B3|Baseline|Total|Total of all reporting groups
990035|NCT00841542|B2|Baseline|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
990036|NCT00841542|B1|Baseline|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
990037|NCT00841542|P2|Participant Flow|Norvasc® (Reference) First|Norvasc® 10 mg tablet (reference) dosed in first period followed by Amlodipine Besylate 10 mg tablet (test) dosed in second period
990038|NCT00841542|P1|Participant Flow|Amlodipine Besylate (Test) First|Amlodipine Besylate 10 mg tablet (test) dosed in first period followed by Norvasc® 10 mg tablet (reference)dosed in second period
990039|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
990040|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
990041|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
990042|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
990043|NCT00841542|O2|Outcome|Norvasc®|Norvasc® 10 mg tablet (reference) dosed in either period
990044|NCT00841542|O1|Outcome|Amlodipine|Amlodipine Besylate 10 mg tablet (test) dosed in either period
990045|NCT00841412|B1|Baseline|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
990046|NCT00841412|P2|Participant Flow|Delayed Intervention Group/Units|Delayed Intervention units (control group) was monitored by research staff under usual care conditions.
990047|NCT00841412|P1|Participant Flow|Immediate Intervention Group/Units|Immediate Intervention units received a staff training and management intervention to improve daily nutritional care processes.
990048|NCT00841412|O1|Outcome|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so outcome measures are reported overall for both groups combined.
990049|NCT00841412|E1|Reported Event|Overall (Both Groups Combined)|Participants were randomized by unit and each unit received intervention so characteristics of participants are reported overall for both groups combined.
990050|NCT00841321|B3|Baseline|Total|Total of all reporting groups
990057|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
990058|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
990059|NCT00841321|O4|Outcome|Placebo Exit|Placebo, one capsule orally twice a day for 12 weeks.
990060|NCT00841321|O3|Outcome|Placebo Baseline|Placebo, one capsule orally twice a day for 12 weeks.
990061|NCT00841321|O2|Outcome|Ginkgo Exit|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
990062|NCT00841321|O1|Outcome|Ginkgo Baseline|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
990063|NCT00841321|E2|Reported Event|Ginkgo|Ginkgo (EGb-761), 120-mg tablet of ginkgo twice a day for 12 weeks.
990064|NCT00841321|E1|Reported Event|Placebo|Placebo, one capsule orally twice a day for 12 weeks.
990065|NCT00841269|B1|Baseline|Open Label Uridine Treatment|All participants were Caucasian. There were 5 female participants and 2 male participants.
990066|NCT00841269|P1|Participant Flow|Open Label Uridine Treatment|Participants received fixed-dose uridine 500 mg twice daily for 6 weeks. At each treatment visit, the following rating scales were administered: The CDRS-R, YMRS, and the Columbia-Suicide Severity Rating Scale (C-SSRS)
990067|NCT00841269|O1|Outcome|Open Label Uridine Treatment|
990068|NCT00841269|E1|Reported Event|Uridine 500 mg by Mouth Twice Daily for 6 Weeks|Because this was an open-label study, all participants received the investigational drug uridine.
990069|NCT00841204|B3|Baseline|Total|Total of all reporting groups
990070|NCT00841204|B2|Baseline|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
990071|NCT00841204|B1|Baseline|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
990072|NCT00841204|P2|Participant Flow|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
990073|NCT00841204|P1|Participant Flow|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
990074|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
990075|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
990076|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
990077|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
990078|NCT00841204|O2|Outcome|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
990079|NCT00841204|O1|Outcome|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
990080|NCT00841204|E2|Reported Event|Placebo|Participants receive oral placebo twice daily for 8 weeks in the absence of unacceptable toxicity.
990081|NCT00841204|E1|Reported Event|Sulindac|Participants receive oral sulindac twice daily for 8 weeks in the absence of unacceptable toxicity.
990082|NCT00841087|B3|Baseline|Total|Total of all reporting groups
990083|NCT00841087|B2|Baseline|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990084|NCT00841087|B1|Baseline|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990085|NCT00841087|P2|Participant Flow|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990086|NCT00841087|P1|Participant Flow|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990087|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990088|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990089|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990090|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990091|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990092|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990093|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990094|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990128|NCT00840996|E1|Reported Event|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990229|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
990095|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990096|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990097|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990098|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990099|NCT00841087|O2|Outcome|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990100|NCT00841087|O1|Outcome|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990101|NCT00841087|E2|Reported Event|Insulin Detemir|Insulin detemir was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990102|NCT00841087|E1|Reported Event|SIBA|Soluble insulin basal analogue (SIBA, insulin degludec) was given subcutaneously once daily (OD) at bedtime and insulin aspart was given subcutaneously immediately before meals three times a day for 6 weeks. Insulin doses were individually adjusted.
990103|NCT00841035|B1|Baseline|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
990104|NCT00841035|P1|Participant Flow|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
990105|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles
990106|NCT00841035|O1|Outcome|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
990107|NCT00841035|E1|Reported Event|Eroltinib Added to Standard of Care|"150 mg of erlotinib for 7 days prior to surgery,then in the adjuvant stage the subject will receive 100mg of erlotinib and gemcitabine 1000mg/2 for 6 cycles~erlotinib : Preoperative dosing of 150 mg oral erlotinib for 7 days before surgery. followed by erlotinib-gemcitabine after surgery for 6 cycles."
990108|NCT00840996|B3|Baseline|Total|Total of all reporting groups
990109|NCT00840996|B2|Baseline|Placebo|Perioperative equal volume of saline placebo IV infusion
990110|NCT00840996|B1|Baseline|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990111|NCT00840996|P2|Participant Flow|Placebo|Perioperative equal volume of saline placebo IV infusion
990112|NCT00840996|P1|Participant Flow|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990113|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
990114|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990115|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
990116|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990117|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
990118|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990119|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
990120|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990121|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
990122|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990123|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
990124|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990125|NCT00840996|O2|Outcome|Placebo|Perioperative equal volume of saline placebo IV infusion
990126|NCT00840996|O1|Outcome|Lidocaine|Perioperative intravenous lidocaine (2 mg/kg/h) with maximum of 200 mg/h starting at induction of anesthesia and continuing until discharge from the PACU or a maximum of 8 hours
990127|NCT00840996|E2|Reported Event|Placebo|Perioperative equal volume of saline placebo IV infusion
990129|NCT00840879|B3|Baseline|Total|Total of all reporting groups
993384|NCT00832416|E4|Reported Event|4: Placebo|
990130|NCT00840879|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
990131|NCT00840879|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
990132|NCT00840879|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
990133|NCT00840879|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
990134|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
990135|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
990136|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
990137|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
990138|NCT00840879|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
990139|NCT00840879|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
990140|NCT00840866|B3|Baseline|Total|Total of all reporting groups
990141|NCT00840866|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
990142|NCT00840866|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
990143|NCT00840866|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
990144|NCT00840866|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
990145|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
990146|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
990147|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
990148|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
990149|NCT00840866|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
990150|NCT00840866|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
990151|NCT00840840|B3|Baseline|Total|Total of all reporting groups
990152|NCT00840840|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
990153|NCT00840840|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
990154|NCT00840840|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
990155|NCT00840840|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
990156|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990157|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990158|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990159|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990160|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990161|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990162|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990163|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990164|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990165|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990166|NCT00840840|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990167|NCT00840840|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990168|NCT00840658|B5|Baseline|Total|Total of all reporting groups
990169|NCT00840658|B4|Baseline|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of motivational interviewing (MI) and principles of Social Cognitive Theory and Theory of Reasoned Action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
990223|NCT00840411|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
990224|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
990170|NCT00840658|B3|Baseline|C:Interactive Sexual Risk & Didactic Safer Injection Education|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI)and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a lecture-format presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
990171|NCT00840658|B2|Baseline|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
990172|NCT00840658|B1|Baseline|A: Didactic Safer Injection & Sexual Activity Education|In each city, 75 women will participate in a 60 minute lecture-format presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
990173|NCT00840658|P4|Participant Flow|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
990174|NCT00840658|P3|Participant Flow|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
990175|NCT00840658|P2|Participant Flow|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
990176|NCT00840658|P1|Participant Flow|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
990177|NCT00840658|O4|Outcome|D: Interactive Injection & Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one-on-one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA) to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., Human Immuno-deficiency Virus (HIV)infection,Sexually Transmitted Infections (STIs, pregnancy)."
990178|NCT00840658|O3|Outcome|C:Interactive Sexual Risk & Didactic Safer Injection Eductatio|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session.~This one on one intervention incorporates elements of MI and principles of social cognitive theory and theory of reasoned action (SCT/TRA)to address the context of unsafe sex and condom use with clients.~In addition, participants will be provided a lecture-type presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
990179|NCT00840658|O2|Outcome|B: Interactive Injection Risk & Didactic Safer Sex Education|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session.~This one on one intervention incorporates elements of motivational interviewing (MI) and principles of social cognitive theory and theory of reasoned action(SCT/TRA) to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared.~In addition, participants will be provided a lecture-type presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
990180|NCT00840658|O1|Outcome|A: Didactic Safer Injection & Sexual Activity Education|"In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on Centers for Disease Control and Prevention (CDC) guidelines for Human Immuno-deficiency Virus (HIV) counseling, testing, and referral and materials from Mexico's National Center for AIDS (Acquired Immuno-Deficiency Syndrome)Studies (CENSIDA).~In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection."
990225|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
990226|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
990227|NCT00840411|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablet (test) dosed in either period
990181|NCT00840658|E4|Reported Event|D: Interactive Injection and Sexual Risk Intervention|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] and Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one-on-one intervention incorporates elements of MI and principles of SCT/TRA to address the context of both, a) unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared; and b) unsafe sex and condom use with clients, and associated risks (e.g., HIV, STIs, pregnancy)."
990182|NCT00840658|E3|Reported Event|C:Interactive Sexual Risk Intervention & Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No Al Sexo Inseguro [Say No to Unsafe Sex'] counseling session. This one on one intervention incorporates elements of MI and principles of SCT/TRA to address the context of unsafe sex and condom use with clients. In addition, participants will be provided a didactic presentation on safer injection sharing. However, in this component, there will be no theory-driven active skill building elements oriented towards safer injection behavior."
990183|NCT00840658|E2|Reported Event|B: Interactive Injection Risk Intervention and Didactic Safer|"In each city, 75 women will participate in the 60 minute Di No a las Jeringas Contaminadas ['Say No to Contaminated Syringes'] counseling session. This one on one intervention incorporates elements of motivational interviewing (MI) and principles of SCT/TRA to address the context of unsafe injection sharing and the extent to which syringes and other injection paraphernalia is shared. In addition, participants will be provided a didactic presentation on safer sex. However, in this component, there will be no theory-driven active skill building elements oriented towards safer sex."
990184|NCT00840658|E1|Reported Event|A: Didactic Safer Injection and Sexual Activity Education|In each city, 75 women will participate in a 60 minute didactic presentation and printed materials on safer sex and safer injection based on CDC guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). In this component, there will be no theory-driven active skill building elements oriented towards safer sex or safer injection.
990185|NCT00840632|B3|Baseline|Total|Total of all reporting groups
990186|NCT00840632|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
990187|NCT00840632|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
990188|NCT00840632|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
990189|NCT00840632|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
990190|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990191|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990192|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990193|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990194|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990195|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990196|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990197|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990198|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990199|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990200|NCT00840632|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990201|NCT00840632|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990202|NCT00840476|B3|Baseline|Total|Total of all reporting groups
990203|NCT00840476|B2|Baseline|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
990204|NCT00840476|B1|Baseline|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
990205|NCT00840476|P2|Participant Flow|Mobic® (Reference) First|Mobic® 15 mg Tablet (reference) dosed in first period followed by Meloxicam 15 mg Tablet (test) dosed in second period
990206|NCT00840476|P1|Participant Flow|Meloxicam (Test) First|Meloxicam 15 mg Tablet (test) dosed in first period followed by Mobic® 15 mg Tablet (reference) dosed in second period
990207|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
990208|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
990209|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
990210|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
990211|NCT00840476|O2|Outcome|Mobic®|Mobic® 15 mg Tablet (reference) dosed in either period
990212|NCT00840476|O1|Outcome|Meloxicam|Meloxicam 15 mg Tablet (test) dosed in either period
990213|NCT00840450|B1|Baseline|Paclitaxel and Imatinib Mesylate (Gleevec)|
990214|NCT00840450|P1|Participant Flow|Paclitaxel and Imatinib Mesylate (Gleevec)|
990215|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
990216|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
990217|NCT00840450|O1|Outcome|Paclitaxel and Imatinib Mesylate (Gleevec)|
990218|NCT00840450|E1|Reported Event|Paclitaxel and Imatinib Mesylate (Gleevec)|
990219|NCT00840411|B3|Baseline|Total|Total of all reporting groups
990220|NCT00840411|B2|Baseline|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
990221|NCT00840411|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablet (test) dosed in first period followed by Biaxin® XL 500 mg Filmtab® (reference) dosed in second period.
990222|NCT00840411|P2|Participant Flow|Biaxin® XL (Reference) First|Biaxin® XL 500 mg Filmtab® (reference) dosed in first period followed by Clarithromycin 500 mg ER Tablet (test) dosed in second period
990228|NCT00840411|O2|Outcome|Biaxin® XL|Biaxin® XL 500 mg Filmtab® (reference) dosed in either period
990231|NCT00840294|B2|Baseline|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
990232|NCT00840294|B1|Baseline|Observation|Observation only for 2 weeks
990233|NCT00840294|P2|Participant Flow|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
990234|NCT00840294|P1|Participant Flow|Observation|Observation only for 2 weeks
990235|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
990236|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
990237|NCT00840294|O2|Outcome|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
990238|NCT00840294|O1|Outcome|Observation|Observation only for 2 weeks
990239|NCT00840294|E2|Reported Event|Antibiotic|Ciprofloxacin 500 mg twice daily for 2 weeks
990240|NCT00840294|E1|Reported Event|Observation|Observation only for 2 weeks
990241|NCT00840281|B3|Baseline|Total|Total of all reporting groups
990242|NCT00840281|B2|Baseline|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
990243|NCT00840281|B1|Baseline|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
990244|NCT00840281|P2|Participant Flow|Cefzil® (Reference) First|500 mg Cefzil® Tablets reference product dosed in first period followed by 500 mg Cefprozil Tablets test product dosed in the second period.
990245|NCT00840281|P1|Participant Flow|Cefprozil (Test) First|500 mg Cefprozil Tablets test product dosed in first period followed by 500 mg Cefzil® Tablets reference product dosed in the second period.
990246|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
990247|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
990248|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
990249|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
990250|NCT00840281|O2|Outcome|Cefzil® (Reference)|500 mg Cefzil® Tablets reference product dosed in either period.
990251|NCT00840281|O1|Outcome|Cefprozil (Test)|500 mg Cefprozil Tablets test product dosed in either period.
990252|NCT00840216|B3|Baseline|Total|Total of all reporting groups
990253|NCT00840216|B2|Baseline|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
990254|NCT00840216|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
990255|NCT00840216|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® XL Filmtab® 500 mg (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
990256|NCT00840216|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg ER Tablets (test) dosed in first period followed by Biaxin® XL Filmtab® 500 mg (reference) dosed in second period
990257|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
990258|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
990259|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
990260|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
990261|NCT00840216|O2|Outcome|Biaxin®|Biaxin® XL Filmtab® 500 mg (reference) dosed in either period
990262|NCT00840216|O1|Outcome|Clarithromycin|Clarithromycin 500 mg ER Tablets (test) dosed in either period
990263|NCT00840203|B3|Baseline|Total|Total of all reporting groups
990264|NCT00840203|B2|Baseline|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
990265|NCT00840203|B1|Baseline|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
990266|NCT00840203|P2|Participant Flow|Rowasa® (Reference) First|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in first period followed by Mesalamine 4gm/60mL Rectal Enema (test) dosed in second period
990267|NCT00840203|P1|Participant Flow|Mesalamine (Test) First|Mesalamine 4gm/60mL Rectal Enema (test) dosed in first period followed by Rowasa® 4gm/60mL Rectal Enema (reference) dosed in second period
990268|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
990269|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
990270|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
990271|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
990272|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
990273|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
990274|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
990275|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
990276|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
990277|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
990278|NCT00840203|O2|Outcome|Rowasa®|Rowasa® 4gm/60mL Rectal Enema (reference) dosed in either period
990279|NCT00840203|O1|Outcome|Mesalamine|Mesalamine 4gm/60mL Rectal Enema (test) dosed in either period
990280|NCT00840099|B3|Baseline|Total|Total of all reporting groups
990281|NCT00840099|B2|Baseline|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
993385|NCT00832416|E3|Reported Event|3: Tramadol Once A Day 300mg|
990365|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990366|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990282|NCT00840099|B1|Baseline|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
990283|NCT00840099|P2|Participant Flow|Reference First|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in first period followed by Amoxicillin and Clavulante Potassium for Oral Suspension 600/42.9 mg/5mL test product dosed in second period
990284|NCT00840099|P1|Participant Flow|Test First|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in first period followed by AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in second period
990285|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990286|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990287|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990288|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990289|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990290|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990291|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990292|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990293|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990294|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990295|NCT00840099|O2|Outcome|AugmentinES-600™|AugmentinES-600™ for Oral Suspension 600/42.9 mg/5mL reference product dosed in either period
990296|NCT00840099|O1|Outcome|Amoxicillin Clavulanate|Amoxicillin and Clavulante Potassium for Oral Suspension, 600/42.9 mg/5mL test product dosed in either period
990297|NCT00840086|B1|Baseline|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
990298|NCT00840086|P1|Participant Flow|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
990299|NCT00840086|O3|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
990300|NCT00840086|O2|Outcome|Part C|Surgery sub-trial: This part of the trial included any of the patients from Part A and Part B that during the course of the trial needed to undergo a major or minor surgical procedure requiring at least 7 days of daily FVIII treatment, including the day of surgery. Patients received a preoperative loading dose of turoctocog alfa immediately prior to the surgical procedure. On the day of surgery and until Day 7 (included) turoctocog alfa was dose adjusted aiming for a trough level above 0.50 IU/mL. Day 8 to last day of the surgical recovery period (if relevant) turoctocog alfa was dosed according to local guidelines.
990301|NCT00840086|O1|Outcome|Total (Part A + Part B)|Preventive treatment and treatment of bleeds: The doses were individualised based on the trough FVIII activity level. The doses could be adjusted by the investigator. The dose level chosen was 20-40 IU/kg every second day or 20-50 IU/kg three times per week (Part A + Part B). Subjects previously treated with turoctocog alpha were included in Part A.
990302|NCT00840086|O1|Outcome|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
990303|NCT00840086|E1|Reported Event|All Subjects Treated With Turoctocog Alfa|All subjects participating in the study (Part A + Part B + Part C).
990304|NCT00840073|B3|Baseline|Total|Total of all reporting groups
990305|NCT00840073|B2|Baseline|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
990306|NCT00840073|B1|Baseline|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
990307|NCT00840073|P2|Participant Flow|Mavik® (Reference) First|Mavik® 4 mg Tablet (reference) dosed in first period followed by Trandolapril 4 mg Tablet (test) dosed in second period
990308|NCT00840073|P1|Participant Flow|Trandolapril (Test) First|Trandolapril 4 mg Tablet (test) dosed in first period followed by Mavik® 4 mg Tablet (reference) dosed in second period
990309|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990310|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990311|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990312|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990313|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990314|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990315|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990316|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990317|NCT00840073|O2|Outcome|Mavik®|Mavik® 4 mg Tablet (reference) dosed in either period
990318|NCT00840073|O1|Outcome|Trandolapril|Trandolapril 4 mg Tablet (test) dosed in either period
990319|NCT00840060|B3|Baseline|Total|Total of all reporting groups
990320|NCT00840060|B2|Baseline|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
990321|NCT00840060|B1|Baseline|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
990363|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990364|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990322|NCT00840060|P2|Participant Flow|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
990323|NCT00840060|P1|Participant Flow|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
990324|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
990325|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
990326|NCT00840060|O2|Outcome|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
990327|NCT00840060|O1|Outcome|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
990328|NCT00840060|E2|Reported Event|Discrete Trial Approach|Children assigned to this treatment group participated in a language treatment following an additive structure. Linguistic content and structure were explicitly targeted.
990329|NCT00840060|E1|Reported Event|Addressing Multiple Aspects of Language Simultaneously|Children assigned to this treatment group participated in language treatment that followed a scaffolded-language structure. Linguistic content and structures were not explicitly targeted.
990330|NCT00839956|B1|Baseline|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
990331|NCT00839956|P1|Participant Flow|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
990332|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
990333|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
990334|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
990335|NCT00839956|O1|Outcome|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
990336|NCT00839956|E1|Reported Event|Arm I (Bortezomib and Vorinostat)|"Patients receive bortezomib IV on days 2 and 5 and vorinostat PO QD on days 1-14. Treatment repeats every 28 days for 12 courses in the absence of disease progression or unacceptable toxicity.~Bortezomib: Given IV~Vorinostat: Given PO"
990337|NCT00839930|B3|Baseline|Total|Total of all reporting groups
990338|NCT00839930|B2|Baseline|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
990339|NCT00839930|B1|Baseline|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
990340|NCT00839930|P2|Participant Flow|Pletal® (Reference) First|Pletal® 50 mg Tablets (reference) dosed in first period followed by Cilostazol 50 mg Tablets (test) dosed in second period
990341|NCT00839930|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 50 mg Tablets (test)dosed in first period followed by Pletal® 50 mg Tablets (reference) dosed in second period
990342|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
990343|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
990344|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
990345|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
990346|NCT00839930|O2|Outcome|Pletal®|Pletal® 50 mg Tablets (reference) dosed in either period
990347|NCT00839930|O1|Outcome|Cilostazol|Cilostazol 50 mg Tablets (test)dosed in either period
990348|NCT00839917|B3|Baseline|Total|Total of all reporting groups
990349|NCT00839917|B2|Baseline|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990350|NCT00839917|B1|Baseline|ProQuad™|Single subcutaneous 0.5 mL vaccination
990351|NCT00839917|P2|Participant Flow|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990352|NCT00839917|P1|Participant Flow|ProQuad™|Single subcutaneous 0.5 mL vaccination
990353|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990354|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990355|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990356|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990357|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990358|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990359|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990360|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990361|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990362|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
993386|NCT00832416|E2|Reported Event|2: Tramadol Once A Day 200mg|
990367|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990368|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990369|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990370|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990371|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990372|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990373|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990374|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990375|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990376|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990377|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990378|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990379|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990380|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990381|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990382|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990383|NCT00839917|O2|Outcome|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990384|NCT00839917|O1|Outcome|ProQuad™|Single subcutaneous 0.5 mL vaccination
990385|NCT00839917|E2|Reported Event|M-M-R™ II and Varivax™|Single subcutaneous 0.5 mL vaccination
990386|NCT00839917|E1|Reported Event|ProQuad™|Single subcutaneous 0.5 mL vaccination
990387|NCT00839800|B3|Baseline|Total|Total of all reporting groups
990388|NCT00839800|B2|Baseline|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990389|NCT00839800|B1|Baseline|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990390|NCT00839800|P2|Participant Flow|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990391|NCT00839800|P1|Participant Flow|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990392|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990393|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990394|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990395|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990396|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990397|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990398|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990399|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990400|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990401|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990402|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990403|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990404|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990405|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990406|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990407|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990408|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990409|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990410|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990411|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990412|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990413|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990414|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990415|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990416|NCT00839800|O2|Outcome|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990417|NCT00839800|O1|Outcome|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990418|NCT00839800|E2|Reported Event|Symbicort+Terbutaline As Needed|Symbicort Turbuhaler 160/4.5 mcg one inhalation twice daily + terbutaline Turbuhaler 0.4 mg as needed
990419|NCT00839800|E1|Reported Event|Symbicort SMART|Symbicort Turbuhaler 160/4.5 microgram (mcg) one inhalation twice daily (bid) + Symbicort Turbuhaler 160/4.5 mcg as needed
990420|NCT00839540|B4|Baseline|Total|Total of all reporting groups
990421|NCT00839540|B3|Baseline|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
990422|NCT00839540|B2|Baseline|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
990423|NCT00839540|B1|Baseline|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
990424|NCT00839540|P3|Participant Flow|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
990425|NCT00839540|P2|Participant Flow|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
990426|NCT00839540|P1|Participant Flow|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
990427|NCT00839540|O3|Outcome|Log Inhibition of 200 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 200 mg/day dosing, measured as Ex-vivo effect.
990428|NCT00839540|O2|Outcome|Log Inhibition of 100 mg/Day Micafungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Micafungin based on 100 mg/day dosing, measured as Ex-vivo effect.
990429|NCT00839540|O1|Outcome|Log Inhibition of 50 mg/Day Caspofungin on Candida Spp.|Measurement of the decrease in organism(Candida spp.) colony counts following exposure of serum containing Caspofungin based on 50 mg/day dosing, measured as Ex-vivo effect.
990430|NCT00839540|E3|Reported Event|Caspofungin (C) 50|Patients receive caspofungin 70 mg loading dose (LD) followed by 50 mg once daily (qd)
990431|NCT00839540|E2|Reported Event|Micafungin (M) 200|Patients receive 200 mg Micafungin (M) once daily
990432|NCT00839540|E1|Reported Event|Micafungin (M) 100|Patients receive Micafungin (M) 100 mg once daily (qd)
990433|NCT00839527|B4|Baseline|Total|Total of all reporting groups
990434|NCT00839527|B3|Baseline|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990435|NCT00839527|B2|Baseline|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990436|NCT00839527|B1|Baseline|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990437|NCT00839527|P3|Participant Flow|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990438|NCT00839527|P2|Participant Flow|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990439|NCT00839527|P1|Participant Flow|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990440|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990441|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990442|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990443|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990510|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990511|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
990513|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990514|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990444|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990445|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990446|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990447|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990448|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990449|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990450|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990451|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990452|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990453|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990454|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990455|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990456|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (&gt;=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990457|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990458|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990459|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990460|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990512|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
993387|NCT00832416|E1|Reported Event|1: Tramadol Once A Day 100mg|
990461|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990462|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990463|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990464|NCT00839527|O3|Outcome|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990465|NCT00839527|O2|Outcome|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990466|NCT00839527|O1|Outcome|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990467|NCT00839527|E3|Reported Event|Albiglutide + Metformin + Glimepiride|Participants received pioglitazone-matching placebo daily orally and albiglutide (30 mg weekly; treatment-masked uptitration if needed to 50 mg weekly) as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990468|NCT00839527|E2|Reported Event|Pioglitazone + Metformin + Glimepiride|Participants received pioglitazone (30 mg daily orally; with treatment-masked uptitration if needed to 45 mg) and albiglutide-matching placebo weekly as a subcutaneous injection via a fully disposable pen injector system with open-label glimepiride (4 mg daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990469|NCT00839527|E1|Reported Event|Placebo + Metformin + Glimepiride|Participants received albiglutide matching placebo as a subcutaneous injection weekly via a fully disposable pen injector system with open-label glimepiride (4 milligrams [mg] daily orally) with metformin (>=1500 mg daily orally). Participants did not receive investigational product during the Follow-up Period.
990470|NCT00839436|B4|Baseline|Total|Total of all reporting groups
990471|NCT00839436|B3|Baseline|20 mcg/kg Cohort|
990472|NCT00839436|B2|Baseline|10 mcg/kg Cohort|
990473|NCT00839436|B1|Baseline|3 mcg/kg Cohort|
990474|NCT00839436|P3|Participant Flow|20 mcg/kg Cohort|
990475|NCT00839436|P2|Participant Flow|10 mcg/kg Cohort|
990476|NCT00839436|P1|Participant Flow|3 mcg/kg Cohort|
990477|NCT00839436|O3|Outcome|20 mcg/kg Cohort|
990478|NCT00839436|O2|Outcome|10 mcg/kg Cohort|
990479|NCT00839436|O1|Outcome|3 mcg/kg Cohort|
990480|NCT00839436|E3|Reported Event|20 mcg/kg Cohort|
990481|NCT00839436|E2|Reported Event|10 mcg/kg Cohort|
990482|NCT00839436|E1|Reported Event|3 mcg/kg Cohort|
990483|NCT00839423|B5|Baseline|Total|Total of all reporting groups
990484|NCT00839423|B4|Baseline|Venlafaxine 225 mg|capsules, daily, orally
990485|NCT00839423|B3|Baseline|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990486|NCT00839423|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990487|NCT00839423|B1|Baseline|Placebo|capsules, daily, orally
990488|NCT00839423|P4|Participant Flow|Venlafaxine 225 mg|capsules, daily, orally
990489|NCT00839423|P3|Participant Flow|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990490|NCT00839423|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990491|NCT00839423|P1|Participant Flow|Placebo|capsules, daily, orally
990492|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
990493|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990494|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990495|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
990496|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
990497|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990498|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990499|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
990500|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
990501|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990502|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990503|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
990504|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
990505|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990506|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990507|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
990508|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
990509|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990517|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990518|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990519|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
990520|NCT00839423|O4|Outcome|Venlafaxine 225 mg|capsules, daily, orally
990521|NCT00839423|O3|Outcome|Vortioxetine 10 mg|encapsulated tablets, daily, orally
990522|NCT00839423|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets, daily, orally
990523|NCT00839423|O1|Outcome|Placebo|capsules, daily, orally
990524|NCT00839423|E4|Reported Event|Venlafaxine 225 mg|
990525|NCT00839423|E3|Reported Event|Vortioxetine 10 mg|
990526|NCT00839423|E2|Reported Event|Vortioxetine 5 mg|
990527|NCT00839423|E1|Reported Event|Placebo|
990528|NCT00839319|B6|Baseline|Total|Total of all reporting groups
990529|NCT00839319|B5|Baseline|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
990530|NCT00839319|B4|Baseline|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
990531|NCT00839319|B3|Baseline|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
990532|NCT00839319|B2|Baseline|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
990533|NCT00839319|B1|Baseline|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
990534|NCT00839319|P5|Participant Flow|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
990535|NCT00839319|P4|Participant Flow|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
990536|NCT00839319|P3|Participant Flow|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
990537|NCT00839319|P2|Participant Flow|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
990538|NCT00839319|P1|Participant Flow|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
990539|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
990540|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
990541|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
990542|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
990543|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
990544|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
990545|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
990546|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
990547|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
990548|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
990549|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
990550|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
990551|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
990552|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
990553|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
990554|NCT00839319|O5|Outcome|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
990555|NCT00839319|O4|Outcome|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
990556|NCT00839319|O3|Outcome|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
990557|NCT00839319|O2|Outcome|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
990558|NCT00839319|O1|Outcome|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
990559|NCT00839319|E5|Reported Event|Acyline Plus Testosterone Gel|ACY 300 ug/kg SQ on Day 1 + Testosterone gel 75 mg/day daily for 10 days
990560|NCT00839319|E4|Reported Event|Acyline Plus 125 IU hCG|ACY 300 ug/kg SQ Day 1 + 125 IU hCG SQ q.o.d (5 doses) for 10 days
990561|NCT00839319|E3|Reported Event|Acyline Plus 60 IU hCG|ACY 300 ug/kg SQ Day 1 + 60 IU hCG SQ q.o.d (5 doses) for 10 days
990562|NCT00839319|E2|Reported Event|Acyline Plus 15 IU hCG|ACY 300 ug/kg SQ on Day 1 plus SQ 15 IU hCG q.o.d (5 doses) for 10 days
990563|NCT00839319|E1|Reported Event|Acyline Plus Placebo|Acyline (ACY) 300 ug/kg subcutaneous (SQ) injections on Day 1 plus SQ placebo hCG every other day(q.o.d) (5 doses) for 10 days
990564|NCT00839306|B3|Baseline|Total|Total of all reporting groups
990565|NCT00839306|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990566|NCT00839306|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990567|NCT00839306|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990923|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990568|NCT00839306|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990569|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990570|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990571|NCT00839306|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose inlcuded 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990572|NCT00839306|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990573|NCT00839306|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990574|NCT00839306|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990575|NCT00839241|B3|Baseline|Total|Total of all reporting groups
990576|NCT00839241|B2|Baseline|Allogenic Blood Transfusion|
990577|NCT00839241|B1|Baseline|Autologous Blood Transfusion|
990578|NCT00839241|P2|Participant Flow|Allogenic Blood Transfusion|
990579|NCT00839241|P1|Participant Flow|Autologous Blood Transfusion|
990580|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990581|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990582|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990583|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990584|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990585|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990586|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990587|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990588|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990589|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990590|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990591|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990592|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990593|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990594|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990595|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990596|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990597|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990598|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990599|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990600|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990601|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990602|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990603|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990604|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990605|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990606|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990607|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990608|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990609|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990610|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990611|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990612|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990613|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990614|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990615|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990616|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990617|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990618|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990619|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990620|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990621|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990622|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990623|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990624|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990625|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990626|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990627|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990628|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990629|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990630|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990631|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990632|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990633|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990634|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990635|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990636|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990637|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990638|NCT00839241|O2|Outcome|Allogenic Blood Transfusion|
990639|NCT00839241|O1|Outcome|Autologous Blood Transfusion|
990829|NCT00838578|P1|Participant Flow|KRN330 + Irinotecan|"Phase 1____ Biweekly KRN330 (0.5 mg/kg) (N=8) Weekly KRN330 (0.5 mg/kg) (N=7) Biweekly KRN330 (1.0 mg/kg) (N=4) Total (N=19)~Phase 2____ Weekly KRN330 (0.5 mg/kg)) (N=46)~Phase 1 and 2Combined (N=65)"
990663|NCT00839098|B3|Baseline|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
990664|NCT00839098|B2|Baseline|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
990665|NCT00839098|B1|Baseline|Control Group|Control Group
990666|NCT00839098|P3|Participant Flow|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
990667|NCT00839098|P2|Participant Flow|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
990668|NCT00839098|P1|Participant Flow|Control Group|Control Group
990669|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
990670|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
990671|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
990672|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
990673|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
990674|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
990675|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
990676|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
990677|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
990678|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
990679|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
990680|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
990681|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
990682|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
990683|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
990684|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
990685|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
990686|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
990687|NCT00839098|O3|Outcome|Arm 3: Instruction + VSC Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD), and timely alert to remind and guide powered seating function usage delivered by the VSC installed on the study wheelchair.
990688|NCT00839098|O2|Outcome|Arm 2: Instruction Group|Participants received: meeting with a clinician once every two weeks, and educational materials (reminder cards, pamphlet, and video CD).
990689|NCT00839098|O1|Outcome|Arm 1: Control Group|Arm 1 (control group) was removed from the study through IRB modification because of difficulties in recruiting participants.
990690|NCT00839098|E3|Reported Event|Instruction and Virtual Coach Group|"Instruction and Virtual Coach Group~Instruction and Virtual Coach Group: Power seat function usage instruction- verbal, written, and virtual coach: Subjects assigned to the Instruction & Virtual Coach Group will be assigned to an Intervention Group Clinician and will receive the same training and instructional materials as the Instruction Group. Subjects will also be instructed in use of the virtual coach system, which will be active during the in-home usage periods to provide personalized feedback. As the Virtual Coach is a dynamic intelligent system, it will adjust its coaching to the needs of the individual. For example, if the person is compliant, the Virtual Coach will give positive feedback and then gradually transition to operating quietly in the background. If a person is not fully compliant, it will alter feedback modes (e.g., verbal cues, auditory tones, visual cues) and timing to attempt to increase compliance."
990691|NCT00839098|E2|Reported Event|Instruction Group|"Instruction Group~Instruction Group: Power seat function usage instruction- verbal and written instruction: Subjects assigned to the Intervention Group will be assigned to an Intervention Group Clinician. The Intervention Group Clinicians will provide the same training as the Control Group Clinicians, with the addition of discussing the veteran's activity and seating function usage data, reviewing and providing a study pamphlet and compact disk as a reference guide on use of power seat functions."
990692|NCT00839098|E1|Reported Event|Control Group|Control Group
990693|NCT00839072|B1|Baseline|Entire Study Population|Includes groups randomized to receive Test first and Reference first.
990694|NCT00839072|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 * 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone Contramid® OAD (Once-A-Day) 300 mg Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
990695|NCT00839072|P1|Participant Flow|Test (Trazodone Contramid® OAD) First|"1 * 300 mg Trazodone Contramid® OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Trazodone IR (Desyrel®) 100 mg tablet 8-hourly reference product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
990696|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990697|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990698|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990699|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990700|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990701|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990702|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990703|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990826|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
990827|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
990704|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990705|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990706|NCT00839072|O2|Outcome|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990707|NCT00839072|O1|Outcome|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990708|NCT00839072|E2|Reported Event|Desyrel®|"Desyrel® 100mg tablets reference product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990709|NCT00839072|E1|Reported Event|Trazodone Contramid® OAD|"Trazodone Contramid® OAD 300 mg Tablets test product dosed in either period. In Period 1 subjects received either one tablet of the test formulation, Trazodone Contramid® OAD 300 mg, or three tablets 8 hours apart of the reference formulation, Desyrel® 100mg, after an overnight fast of at least 10 hours, followed by a 7 day washout period. In Period 2 subjects received the alternate regimen following an overnight fast of at least 10 hours.~OAD = Once A Day"
990710|NCT00838929|B4|Baseline|Total|Total of all reporting groups
990711|NCT00838929|B3|Baseline|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990712|NCT00838929|B2|Baseline|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990713|NCT00838929|B1|Baseline|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990714|NCT00838929|P3|Participant Flow|Vorinostat (400 mg) and Radiation|
990715|NCT00838929|P2|Participant Flow|Vorinostat (300 mg) and Radiation|
990716|NCT00838929|P1|Participant Flow|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990717|NCT00838929|O1|Outcome|Vorinostat and Radiation - All Participants|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level -2 - 50 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level -1 - 100 mg PO qd (to be used in de-escalation if toxicity occurs) Dose level I - 200 mg PO qd (initial starting dose) Dose level II - 300 mg PO qd Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990718|NCT00838929|E3|Reported Event|Vorinostat (400 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level III - 400 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990719|NCT00838929|E2|Reported Event|Vorinostat (300 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level II - 300 mg PO qd~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990720|NCT00838929|E1|Reported Event|Vorinostat (200 mg) and Radiation|"Patients will be treated on a dose escalation model for vorinostat and concurrently receive radiation therapy.~Vorinostat : All doses given for 3 weeks~Dose level I - 200 mg PO qd (initial starting dose)~Radiation Therapy : Patients will take Vorinostat daily during radiation therapy, they will be recommended to swallow the capsule 60-90 minutes prior to estimate time of radiation."
990721|NCT00838916|B3|Baseline|Total|Total of all reporting groups
990828|NCT00838578|B1|Baseline|KRN330 + Irinotecan|open label, single arm
990918|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990722|NCT00838916|B2|Baseline|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990723|NCT00838916|B1|Baseline|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990724|NCT00838916|P2|Participant Flow|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990725|NCT00838916|P1|Participant Flow|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990726|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990727|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990728|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990729|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990730|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990731|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990732|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990733|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990734|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990735|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990736|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990737|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990738|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990919|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990739|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990740|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990741|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990742|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990743|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990744|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990745|NCT00838916|O2|Outcome|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990746|NCT00838916|O1|Outcome|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990747|NCT00838916|E2|Reported Event|Insulin Glargine 10 Units + Metformin +/- Sulfonylurea|Participants received 10 units of insulin glargine daily (with dose adjusted weekly depending on the need for additional glycemic control) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990748|NCT00838916|E1|Reported Event|Albiglutide 30 mg + Metformin +/- Sulfonylurea|Participants received albiglutide 30 milligrams (mg) weekly (with up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus or minus sulfonylurea from Baseline to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990749|NCT00838903|B5|Baseline|Total|Total of all reporting groups
990750|NCT00838903|B4|Baseline|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990751|NCT00838903|B3|Baseline|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990752|NCT00838903|B2|Baseline|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990753|NCT00838903|B1|Baseline|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990754|NCT00838903|P4|Participant Flow|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990755|NCT00838903|P3|Participant Flow|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990756|NCT00838903|P2|Participant Flow|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990920|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990757|NCT00838903|P1|Participant Flow|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990758|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990759|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990760|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990761|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990762|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990763|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990764|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990765|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990766|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990767|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990768|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990769|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990770|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990771|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990772|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990773|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990774|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
993388|NCT00832390|B4|Baseline|Total|Total of all reporting groups
990775|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990776|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990777|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990778|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990779|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990780|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990781|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990782|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990783|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990784|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990785|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990786|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990787|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990788|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990789|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990790|NCT00838903|O4|Outcome|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990791|NCT00838903|O3|Outcome|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990792|NCT00838903|O2|Outcome|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
991008|NCT00837824|P1|Participant Flow|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
990793|NCT00838903|O1|Outcome|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990794|NCT00838903|E4|Reported Event|Albiglutide 30 mg Plus Metformin|Participants received albiglutide 30 mg weekly (with masked up-titration to 50 mg weekly if required) as a subcutaneous injection via a fully disposable pen injector system plus metformin >=1500 mg daily plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990795|NCT00838903|E3|Reported Event|Glimepiride 2 mg Plus Metformin|Participants received glimepiride 2 mg daily (with masked up-titration to 4 mg daily if required) plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990796|NCT00838903|E2|Reported Event|Sitagliptin 100 mg Plus Metformin|Participants received sitagliptin 100 mg daily plus metformin >=1500 mg daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990797|NCT00838903|E1|Reported Event|Placebo Plus Metformin|Participants received metformin >=1500 milligrams (mg) daily plus matching albiglutide placebo as a subcutaneous injection weekly via a fully disposable pen injector system plus matching sitagliptin placebo plus matching glimepiride placebo from Week 1 to Week 156. All participants returned for the 8-week post-treatment Follow-up Period.
990798|NCT00838682|B3|Baseline|Total|Total of all reporting groups
990799|NCT00838682|B2|Baseline|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990800|NCT00838682|B1|Baseline|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990801|NCT00838682|P2|Participant Flow|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990802|NCT00838682|P1|Participant Flow|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990803|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990804|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990805|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990806|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990807|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990808|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990809|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990810|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990811|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990812|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990813|NCT00838682|O2|Outcome|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990814|NCT00838682|O1|Outcome|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990815|NCT00838682|E2|Reported Event|Omeprazole|Intravenous Omeprazole 80 mg as a bolus injection followed by continuous infusion at 8 mg per hour for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990816|NCT00838682|E1|Reported Event|Rabeprazole Sodium|Oral Rabeprazole 20 mg twice daily for 3 days. From Day 4, oral Rabeprazole 10 mg once daily for 6 weeks as maintenance therapy.
990817|NCT00838630|B3|Baseline|Total|Total of all reporting groups
990818|NCT00838630|B2|Baseline|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
990819|NCT00838630|B1|Baseline|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
990820|NCT00838630|P2|Participant Flow|Pletal® (Reference) First|Pletal® 100 mg Tablets (reference) dosed in first period followed by Cilostazol 100 mg Tablets (test) dosed in second period
990821|NCT00838630|P1|Participant Flow|Cilostazol (Test) First|Cilostazol 100 mg Tablets (test) dosed in first period followed by Pletal® 100 mg Tablets (reference) dosed in second period.
990822|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
990823|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
990824|NCT00838630|O2|Outcome|Pletal®|Pletal® 100 mg Tablets (reference) dosed in either period
990825|NCT00838630|O1|Outcome|Cilostazol|Cilostazol 100 mg Tablets (test) dosed in either period
990830|NCT00838578|O3|Outcome|PH 2 Treatment: KRN330 Wkly + IRI Biwkly|The Phase 2 portion was a single arm study using the regimen and dose selected in Phase 1 (0.5 mg/kg KRN330 weekly and 180 mg/m2 irinotecan biweekly).
990831|NCT00838578|O2|Outcome|Regimen B: KRN330 Weekly + Irinotecan Biweekly|treatment regimen B, KRN330 was administered weekly (Weeks 1, 2, 3, 4 and 5) and irinotecan (180 mg/m2) biweekly (Weeks 1, 3, and 5).
990832|NCT00838578|O1|Outcome|Regimen A: KRN330 Biweekly + Irinotecan Biweekly|"In treatment regimen A, both KRN330 and irinotecan (180 mg/m2) were administered biweekly(Weeks 1, 3, and 5).~Cohort 1: 1 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly Cohort 2: 0.5 mg/kg KRN330 biweekly and 180 mg/m2 irinotecan biweekly"
990833|NCT00838578|E3|Reported Event|Phase 2: KRN330 Weekly + IRI Biweekly|The Phase 2 portion had a single arm in which patients received Regimen B as included in the Phase 1 portion
990834|NCT00838578|E2|Reported Event|Phase 1 Regimen B: KRN330 Weekly + IRI Biweekly|In Regimen B, patients received KRN330 0.5 mg/kg weekly (Weeks 1, 2, 3, 4, and 5) and irinotecan 180 mg/m2 biweekly (Weeks 1, 3, and 5)
990835|NCT00838578|E1|Reported Event|Phase 1 Regimen A: KRN330 Biweekly + IRI Biweekly|"In Regimen A, patients received both KRN330 and irinotecan biweekly (Weeks 1, 3, and 5):~Cohort 1: KRN330 1.0 mg/kg + irinotecan 180 mg/m2 Cohort 2: KRN330 0.5 mg/kg + irinotecan 180 mg/m2"
990836|NCT00838526|B3|Baseline|Total|Total of all reporting groups
990837|NCT00838526|B2|Baseline|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990838|NCT00838526|B1|Baseline|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990839|NCT00838526|P2|Participant Flow|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990840|NCT00838526|P1|Participant Flow|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990841|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990842|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990843|NCT00838526|O2|Outcome|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990844|NCT00838526|O1|Outcome|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990845|NCT00838526|E2|Reported Event|RAB ER 50mg QD|Morning dose included 1 x RAB ER 50mg capsule and 1 x Placebo to match RAN 150mg capsule. Evening dose included 1 x Placebo to match RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990846|NCT00838526|E1|Reported Event|RAN 150mg BID|Morning dose included 1 x Placebo to match RAB (Rabeprazole) ER (Extended Release) 50mg capsule and 1 x RAN (Ranitidine) 150mg capsule. Evening dose included 1 x RAN 150mg capsule. Received study drug orally daily for 26 weeks.
990847|NCT00838513|B1|Baseline|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990848|NCT00838513|P1|Participant Flow|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990849|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990850|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990851|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990868|NCT00838279|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
990921|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990869|NCT00838279|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
991011|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
990852|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990853|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990854|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990855|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990856|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990857|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990858|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990859|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990860|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990861|NCT00838513|O1|Outcome|Eculizumab|eculizumab: All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990862|NCT00838513|E1|Reported Event|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
990863|NCT00838331|B1|Baseline|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
990864|NCT00838331|P1|Participant Flow|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
990865|NCT00838331|O1|Outcome|Fresh Blood, Then Aged Blood|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
990866|NCT00838331|E1|Reported Event|All Subjects|Subjects donated one unit of blood, which was processed, stored for 3-5 days, then infused back to the subject (Fresh Blood). At least 8 weeks later, they returned, donated another unit of blood, which was stored for 40-42 days, then infused back to the subject (Aged Blood). Before and after each transfusion, the subjects was tested with a variety of methods to assess their blood vessel function.
990867|NCT00838279|B3|Baseline|Total|Total of all reporting groups
990870|NCT00838279|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
990871|NCT00838279|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
990872|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
990873|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
990874|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
990875|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
990876|NCT00838279|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
990877|NCT00838279|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
990878|NCT00838201|B3|Baseline|Total|Total of all reporting groups
990879|NCT00838201|B2|Baseline|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990880|NCT00838201|B1|Baseline|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990881|NCT00838201|P2|Participant Flow|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990882|NCT00838201|P1|Participant Flow|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990883|NCT00838201|O2|Outcome|Denosumab/Denosumab 60 mg SC Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990884|NCT00838201|O1|Outcome|Placebo/Denosumab 60 mg SC Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990885|NCT00838201|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Denosumab 60 mg SC Q6M in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990886|NCT00838201|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Placebo in the parent study (NCT00089674), and denosumab 60 mg SC Q6M in the current study
990887|NCT00838162|B5|Baseline|Total|Total of all reporting groups
990888|NCT00838162|B4|Baseline|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990889|NCT00838162|B3|Baseline|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990890|NCT00838162|B2|Baseline|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990891|NCT00838162|B1|Baseline|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990892|NCT00838162|P4|Participant Flow|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990893|NCT00838162|P3|Participant Flow|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990894|NCT00838162|P2|Participant Flow|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990895|NCT00838162|P1|Participant Flow|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990896|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990897|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990898|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990899|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990900|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990901|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990902|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990903|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990904|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990905|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990906|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990907|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990908|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990909|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990910|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990911|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990912|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990913|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990914|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990915|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990916|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990917|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
996993|NCT00823043|O1|Outcome|Timolol Hemihydrate|
990922|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
1028789|NCT00747344|O2|Outcome|Ustekinumab 45 mg|
990924|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990925|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990926|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990927|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990928|NCT00838162|O4|Outcome|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990929|NCT00838162|O3|Outcome|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990930|NCT00838162|O2|Outcome|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990931|NCT00838162|O1|Outcome|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990932|NCT00838162|E4|Reported Event|TMC310911/Rtv 300/100 mg Once a Day|TMC310911 300 mg + ritonavir 100 mg once a day on Days 1 to 14
990933|NCT00838162|E3|Reported Event|TMC310911/Rtv 300/100 mg Twice Daily|TMC310911 300 mg + ritonavir 100 mg twice daily on Days 1 to 14
990934|NCT00838162|E2|Reported Event|TMC310911/Rtv 150/100 mg Twice Daily|TMC310911 150 mg + ritonavir 100 mg twice daily on Days 1 to 14
990935|NCT00838162|E1|Reported Event|TMC310911/Rtv 75/100 mg Twice Daily|TMC310911 75 mg + ritonavir 100 mg twice daily on Days 1 to 14
990936|NCT00838136|B3|Baseline|Total|Total of all reporting groups
990937|NCT00838136|B2|Baseline|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
990938|NCT00838136|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
990939|NCT00838136|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in first period followed by Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in second period
990940|NCT00838136|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in first period followed by Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in second period
990941|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
990942|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
990943|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
990944|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
990945|NCT00838136|O2|Outcome|Lamictal®|Lamictal® 2 x 25 mg Chewable Tablet (reference) dosed in either period
990946|NCT00838136|O1|Outcome|Lamotrigine|Lamotrigine 2 x 25 mg Chewable Tablet (test) dosed in either period
990947|NCT00838110|B3|Baseline|Total|Total of all reporting groups
990948|NCT00838110|B2|Baseline|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
990949|NCT00838110|B1|Baseline|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
990950|NCT00838110|P4|Participant Flow|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
990951|NCT00838110|P3|Participant Flow|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
990952|NCT00838110|P2|Participant Flow|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
990953|NCT00838110|P1|Participant Flow|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
990954|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
990955|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
990956|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
990957|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
990958|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
990959|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
990960|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
990961|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
990962|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg Dimebon (latrepirdine) tablet orally three times a day up to Week 12.
990963|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
990964|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
990965|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
990966|NCT00838110|O2|Outcome|Placebo (Cohort 2)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 12.
990967|NCT00838110|O1|Outcome|Dimebon (Cohort 2)|Dimebon (latrepirdine) 10 mg tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 12.
990968|NCT00838110|O2|Outcome|Placebo (Cohort 1)|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26.
990969|NCT00838110|O1|Outcome|Dimebon (Cohort 1)|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26.
990970|NCT00838110|E2|Reported Event|Placebo|Placebo tablet matched to 10 mg of dimebon (latrepirdine) tablet orally three times a day for 1 week (titration period), followed by placebo tablet matched to 20 mg dimebon (latrepirdine) tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
990971|NCT00838110|E1|Reported Event|Dimebon|Dimebon (latrepirdine) 10 milligram (mg) tablet orally three times a day for 1 week (titration period), followed by dimebon (latrepirdine) 20 mg tablet orally three times a day up to Week 26 for cohort 1 and up to Week 12 for cohort 2.
990972|NCT00838097|B1|Baseline|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990973|NCT00838097|P1|Participant Flow|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990974|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990975|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990976|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990977|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990978|NCT00838097|O1|Outcome|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990979|NCT00838097|E1|Reported Event|Darbepoetin Alfa|Participants with chronic kidney disease who received darbepoetin alfa for the treatment of anaemia as part of routine clinical practice.
990980|NCT00837967|B1|Baseline|All Study Participants|
990981|NCT00837967|P2|Participant Flow|Terbutaline First, Then Symbicort|Terbutaline Turbuhaler 0.4 mg for 3 days First, then Symbicort Turbuhaler 160/4.5μg for 3 days,
990982|NCT00837967|P1|Participant Flow|Symbicort First, Then Terbutaline|Symbicort Turbuhaler 160/4.5μg for 3 days First , then Terbutaline Turbuhaler 0.4 mg for 3 days
990983|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
990984|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
990985|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
990986|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
990987|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
990988|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
990989|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
990990|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
990991|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
990992|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
990993|NCT00837967|O2|Outcome|Terbutaline|Terbutaline Turbuhaler 0.4 mg
990994|NCT00837967|O1|Outcome|Symbicort|Symbicort Turbuhaler 160/4.5μg
990995|NCT00837967|E2|Reported Event|Terbutaline|Terbutaline Turbuhaler 0.4 mg for 3 days
990996|NCT00837967|E1|Reported Event|Symbicort|Symbicort Turbuhaler 160/4.5μg for 3 days
990997|NCT00837876|B1|Baseline|Treatment|Sorafenib + Erlotinib
990998|NCT00837876|P1|Participant Flow|Treatment|Sorafenib + Erlotinib
990999|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
991000|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
991001|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
991002|NCT00837876|O1|Outcome|Treatment|Sorafenib + Erlotinib
991003|NCT00837876|E1|Reported Event|Treatment|Sorafenib + Erlotinib
991004|NCT00837824|B3|Baseline|Total|Total of all reporting groups
991005|NCT00837824|B2|Baseline|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
991006|NCT00837824|B1|Baseline|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
991007|NCT00837824|P2|Participant Flow|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
991009|NCT00837824|O2|Outcome|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
991010|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
1028790|NCT00747344|O1|Outcome|Placebo|
991012|NCT00837824|O1|Outcome|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
991013|NCT00837824|E3|Reported Event|Total|
991014|NCT00837824|E2|Reported Event|Fabrazyme 3mg/kg Every 2 Weeks|Fabrazyme 3.0 mg/kg every 2 weeks
991015|NCT00837824|E1|Reported Event|Fabrazyme 1mg/kg Every 2 Weeks|Fabrazyme 1.0 mg/kg every 2 weeks
991016|NCT00837759|B1|Baseline|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991017|NCT00837759|P1|Participant Flow|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991018|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991019|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991020|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991021|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991022|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991023|NCT00837759|O1|Outcome|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991024|NCT00837759|E1|Reported Event|T1D Group|Subjects between the ages of 16 and 30 years, with T1D diagnosed within the preceding 6 month period, and with measurable circulating C-peptide levels.
991025|NCT00837616|B3|Baseline|Total|Total of all reporting groups
991026|NCT00837616|B2|Baseline|Group B|Group B received the transdermal estradiol for 12 months
991027|NCT00837616|B1|Baseline|Group A|Group A received the oral estradiol for 12 months
991028|NCT00837616|P2|Participant Flow|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991029|NCT00837616|P1|Participant Flow|Oral Estradiol|Group A received the oral estradiol for 12 months
991030|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991031|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991032|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991033|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991034|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991035|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991036|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991037|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991038|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991039|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991040|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991041|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991042|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991043|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991044|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991045|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991046|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991047|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991048|NCT00837616|O2|Outcome|Transdermal Estradiol|Group B received the transdermal estradiol for 12 months
991049|NCT00837616|O1|Outcome|Oral Estradiol|Group A received the oral estradiol for 12 months
991050|NCT00837616|E2|Reported Event|Group B|Group B received the transdermal estradiol for 12 months
991051|NCT00837616|E1|Reported Event|Group A|Group A received the oral estradiol for 12 months
991052|NCT00837577|B3|Baseline|Total|Total of all reporting groups
991053|NCT00837577|B2|Baseline|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
991054|NCT00837577|B1|Baseline|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
991055|NCT00837577|P2|Participant Flow|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
991056|NCT00837577|P1|Participant Flow|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
991057|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
991058|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
991059|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
991060|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
996994|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
991061|NCT00837577|O2|Outcome|Placebo/Sitagliptin|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
991062|NCT00837577|O1|Outcome|Sitagliptin/Sitagliptin|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
991063|NCT00837577|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all participants who took sitagliptin in either treatment group: data from Week 0 to Week 52 for participants in the Sitagliptin/Sitagliptin group; data from Weeks 12 through Week 52 for participants in the Placebo/Sitagliptin group; and data from participants in either group who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
991064|NCT00837577|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|Placebo for 12 weeks (double-blind period) followed by sitagliptin for 40 weeks (open-label period).
991065|NCT00837577|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|Sitagliptin for 12 weeks (double-blind period) followed by sitagliptin for an additional 40 weeks (open-label period).
991066|NCT00837512|B1|Baseline|Entire Study Population|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
991067|NCT00837512|P2|Participant Flow|First: Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
991068|NCT00837512|P1|Participant Flow|First: Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
991069|NCT00837512|O2|Outcome|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
991070|NCT00837512|O1|Outcome|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
991071|NCT00837512|E2|Reported Event|Subcutaneous Insulin Catheter|Subcutaneous insulin catheter : Subcutaneous insulin catheter used to deliver insulin at a depth of 9 mm (9000 micrometers)
991072|NCT00837512|E1|Reported Event|Microneedle|Microneedle : Microneedle used to deliver insulin at a depth less than 900 micrometers
991073|NCT00837486|B3|Baseline|Total|Total of all reporting groups
991074|NCT00837486|B2|Baseline|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
991075|NCT00837486|B1|Baseline|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
991076|NCT00837486|P2|Participant Flow|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
991077|NCT00837486|P1|Participant Flow|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
991078|NCT00837486|O1|Outcome|All Enrolled Subjects|The 30 subjects were followed an average of 36 months after enrollment.
991079|NCT00837486|O1|Outcome|Long-term Open-label Treatment|All subjects received open-label active stimulation after the 16 week blinded-treatment phase.
991080|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
991081|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
991082|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
991083|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
991084|NCT00837486|O2|Outcome|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
991085|NCT00837486|O1|Outcome|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
991086|NCT00837486|E2|Reported Event|Control Group-Sham Stimulation|Receive sham stimulation during the first 16 weeks after device implant.
991087|NCT00837486|E1|Reported Event|Active Group-Active Stimulation|Receive active stimulation during the first 16 weeks after device implant.
991088|NCT00837447|B1|Baseline|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
991089|NCT00837447|P1|Participant Flow|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
991090|NCT00837447|O2|Outcome|High-Flexion Posterior Cruciate Scrificing TKA|
991091|NCT00837447|O1|Outcome|High-Flexion Posterior Cruciate Retaining TKA|
991092|NCT00837447|E1|Reported Event|NexGen CR and CR-flex Knee Prosthesis|The NexGen posterior cruciate-retaining total knee arthroplasty prosthesis (NexGen CR Prosthesis; Zimmer)) on one side and The NexGen posterior cruciate-retaining flex total knee arthroplasty prosthesis (NexGen CR-Flex; Zimmer) on the other side
991093|NCT00837434|B3|Baseline|Total|Total of all reporting groups
991094|NCT00837434|B2|Baseline|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991095|NCT00837434|B1|Baseline|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991096|NCT00837434|P2|Participant Flow|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991097|NCT00837434|P1|Participant Flow|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991098|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991099|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991100|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991204|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991101|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991102|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991103|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991104|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991105|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991106|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991107|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991108|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991109|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991110|NCT00837434|O2|Outcome|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991111|NCT00837434|O1|Outcome|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991112|NCT00837434|E2|Reported Event|Adalimumab|Participants were randomized to receive one subcutaneous injection of 40 mg adalimumab every other week for 24 weeks.
991113|NCT00837434|E1|Reported Event|Etanercept|Participants were randomized to receive 50 mg etanercept given by subcutaneous injection every week for 24 weeks.
991114|NCT00837330|B3|Baseline|Total|Total of all reporting groups
991115|NCT00837330|B2|Baseline|Ranibizumab 0.3 mg/ 0.05 cc|Intraocular injection of 0.3 mg /0.05 cc ranibizumab
991116|NCT00837330|B1|Baseline|Ranibizumab 0.5 mg/ 0.05 cc|Intraocular injection of 0.5 mg /0.05 cc ranibizumab
991117|NCT00837330|P2|Participant Flow|Intraocular Injection 0.3 mg Ranibizumab|10 patients will receive intraocular injection 0.3 mg ranibizumab
991118|NCT00837330|P1|Participant Flow|Intraocular Injection 0.5 mg Ranibizumab|10 patients will receive intraocular injection 0.5 mg ranibizumab
991119|NCT00837330|O2|Outcome|Ranibizumab 0.3 mg|Intraocular injection 0.3 mg ranibizumab
991120|NCT00837330|O1|Outcome|Ranibizumab 0.5 mg|Intraocular injection of 0.5 mg ranibizumab
991121|NCT00837330|E2|Reported Event|Ranibizumab 0.3 mg|Intravitreal Injection of Ranibizumab 0.5 mg
991122|NCT00837330|E1|Reported Event|Ranibizumab 0.5 mg|Intravitreal Injection of Ranibizumab 0.5 mg
991123|NCT00837252|B1|Baseline|Finasteride|
991124|NCT00837252|P1|Participant Flow|Finasteride|All five study participants (all of whom were diagnosed with chronic CSC) were administered a 5mg oral dose of finasteride daily for three months. After three months, the finasteride was withheld and the participants were observed for another three months.
991125|NCT00837252|O1|Outcome|Finasteride|
991126|NCT00837252|O1|Outcome|Finasteride|
991127|NCT00837252|O1|Outcome|Finasteride|
991128|NCT00837252|O1|Outcome|Finasteride|
991129|NCT00837252|O1|Outcome|Finasteride|
991130|NCT00837252|O1|Outcome|Finasteride|
991131|NCT00837252|O1|Outcome|Finasteride|
991132|NCT00837252|O1|Outcome|Finasteride|
991133|NCT00837252|O1|Outcome|Finasteride|
991134|NCT00837252|O1|Outcome|Finasteride|
991135|NCT00837252|O1|Outcome|Finasteride|
991136|NCT00837252|O1|Outcome|Finasteride|
991137|NCT00837252|E1|Reported Event|Finasteride|
991138|NCT00837213|B3|Baseline|Total|Total of all reporting groups
991139|NCT00837213|B2|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991140|NCT00837213|B1|Baseline|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991141|NCT00837213|P2|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991142|NCT00837213|P1|Participant Flow|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991143|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991144|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991145|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991146|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991147|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991148|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991149|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991150|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991151|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991152|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991153|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991154|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991155|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991156|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991157|NCT00837213|O2|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991158|NCT00837213|O1|Outcome|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991159|NCT00837213|E2|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam -Doxycycline Capsules|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily. Doxycycline 100 mg capsules were taken once a day.
991160|NCT00837213|E1|Reported Event|Benzoyl Peroxide Wash -Clindamycin Foam|Benzoyl peroxide wash applied in the shower or bath daily with Clindamycin foam applied after the shower or bath daily.
991161|NCT00837200|B1|Baseline|Treatment|Oncaspar 2500 IU/m2 D1,15; Doxil 20mg/m2 D1,15; Decadron 20 mg D1,8,15,22
991162|NCT00837200|P1|Participant Flow|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
991163|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
991164|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
991165|NCT00837200|O1|Outcome|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
991166|NCT00837200|E1|Reported Event|ODD Regimen|"Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects.~Oncaspar, Doxil, Decadron: Once enrolled, patients will receive a cycle (28 days) of Oncaspar (2500 IU/m2 IV on days 1, 15; Doxil 20 mg/m2 IV days 1,15; and Decadron 20 mg PO days 1, 8, 15, 22. Continue until disease progression or unacceptable side effects."
991167|NCT00837161|B1|Baseline|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
991168|NCT00837161|P1|Participant Flow|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
991169|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
991170|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
991171|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
991172|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
991205|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991206|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991207|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991208|NCT00836875|B3|Baseline|Total|Total of all reporting groups
991173|NCT00837161|O1|Outcome|HIFU Treated|Women indicated for total abdominal hysterectomy underwent a single Magnetic Resonance guided-High Intensity Focused Ultrasound (MR-HIFU) session for uterine fibroid ablation prior to surgery. Subjects were followed up until the date of hysterectomy, or for 30 days if hysterectomy was declined.
991174|NCT00837161|E1|Reported Event|HIFU Treatment|
991175|NCT00837148|B1|Baseline|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
991176|NCT00837148|P1|Participant Flow|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
991177|NCT00837148|O1|Outcome|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
991178|NCT00837148|E1|Reported Event|Soft Tissue Sarcoma Patients|Sorafenib and Dacarbazine in Soft Tissue Sarcoma
991179|NCT00837031|B1|Baseline|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
991180|NCT00837031|P1|Participant Flow|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
991181|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
991182|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
991183|NCT00837031|O1|Outcome|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
991184|NCT00837031|E1|Reported Event|Lenalidomide/Gemcitabine|The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
991185|NCT00836953|B1|Baseline|Study Group|Participants received study vaccine on Days 0 and 30.
991186|NCT00836953|P1|Participant Flow|Study Group|Participants received study vaccine on Days 0 and 30.
991187|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
991188|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
991189|NCT00836953|O1|Outcome|Study Group|Participants received study vaccine on Days 0 and 30.
991190|NCT00836953|E1|Reported Event|Study Group|Participants received study vaccine on Days 0 and 30.
991191|NCT00836901|B3|Baseline|Total|Total of all reporting groups
991192|NCT00836901|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
991193|NCT00836901|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
991194|NCT00836901|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
991195|NCT00836901|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
991196|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991197|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991198|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991199|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991200|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991201|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991202|NCT00836901|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991203|NCT00836901|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
996995|NCT00823043|O1|Outcome|Timolol Hemihydrate|
991209|NCT00836875|B2|Baseline|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991210|NCT00836875|B1|Baseline|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991211|NCT00836875|P2|Participant Flow|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991212|NCT00836875|P1|Participant Flow|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991213|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991214|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991215|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991216|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991217|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991218|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991219|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991220|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991221|NCT00836875|O2|Outcome|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991222|NCT00836875|O1|Outcome|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991251|NCT00836693|P2|Participant Flow|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991315|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991223|NCT00836875|E2|Reported Event|Voriconazole: 12 to <18 Years|Participants aged 12 to <18 years (excluding those aged 12-14 years weighing <50 kg) received a loading dose of 6 mg/kg IV q12h for the first 24 hours followed by maintenance dosing of 4 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral therapy and received 200-300 mg PO q12h.
991224|NCT00836875|E1|Reported Event|Voriconazole: 2 to <12 Years|Participants aged 2 to less than (<)12 years (and young adolescents aged 12 to 14 years weighing <50 kilograms [kg]) received a loading dose of voriconazole of 9 milligrams per kg (mg/kg), intravenously (IV), every 12 hours (q12h) for the first 24 hours, followed by maintenance dosing of 8 mg/kg IV q12h for a minimum of 7 days of IV therapy. Once significant clinical improvement was observed, participants could have been switched or oral (PO) therapy and received 9 mg/kg PO voriconazole q12h for a maximum dose of 350 mg.
991225|NCT00836745|B1|Baseline|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
991226|NCT00836745|P1|Participant Flow|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
991227|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
991228|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
991229|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
991230|NCT00836745|O1|Outcome|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
991231|NCT00836745|E1|Reported Event|Sunitinib|Participants who received sunitinib capsule once daily as per local product information, were followed up for 1 year or till the occurrence of disease progression, early discontinuation of sunitinib therapy (due to unacceptable toxicity, participant’s request or lost to follow up), or death, whichever occurred earlier. Sunitinib dose was adjusted solely according to medical and therapeutic needs.
991232|NCT00836719|B1|Baseline|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
991233|NCT00836719|P1|Participant Flow|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
991234|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
991235|NCT00836719|O1|Outcome|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
991236|NCT00836719|E1|Reported Event|Polyphenon E|"Standarized green tea extract containing 50% EGCG~Polyphenon E : Polyphenon E capsules containing 200 mg of Epigallocachin-galleate.~Two capsules twice a day."
991237|NCT00836706|B3|Baseline|Total|Total of all reporting groups
991238|NCT00836706|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
991239|NCT00836706|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
991240|NCT00836706|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet (test) dosed in second period.
991241|NCT00836706|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablets (test) dosed in first period followed by Biaxin® 500 mg Tablets (reference) dosed in second period.
991242|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
991243|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
991244|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
991245|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
991246|NCT00836706|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
991247|NCT00836706|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablets (test) dosed in either period
991248|NCT00836693|B3|Baseline|Total|Total of all reporting groups
991249|NCT00836693|B2|Baseline|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991250|NCT00836693|B1|Baseline|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
992389|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
991252|NCT00836693|P1|Participant Flow|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991253|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991254|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991255|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991256|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991257|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991258|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991259|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991260|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991261|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991262|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991263|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991264|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991265|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991266|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991267|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991268|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991269|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991270|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991271|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991272|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991273|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991274|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991275|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991276|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991277|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991278|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991279|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991280|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991281|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991391|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
991282|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991283|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991284|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991285|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991286|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991287|NCT00836693|O2|Outcome|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration for 12 weeks.
991288|NCT00836693|O1|Outcome|Tadalafil|Tadalafil 5 milligrams (mg) administered orally once a day for 12 weeks. Dosing started at 5 mg tadalafil daily and could be down-titrated to 2.5 mg tadalafil daily based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991289|NCT00836693|E2|Reported Event|Placebo|Placebo tablets, matching 5 mg and 2.5 mg tadalafil tablets, given once daily by oral administration.
991290|NCT00836693|E1|Reported Event|Tadalafil|Tadalafil 5 milligrams administered orally once a day over 12 weeks. Dosing started at 5 mg tadalafil daily (or matching placebo) and could be down-titrated to 2.5 mg tadalafil daily (or matching placebo) based on individual tolerability. (Doses could subsequently be increased back to 5 mg based on response.)
991291|NCT00836641|B3|Baseline|Total|Total of all reporting groups
991292|NCT00836641|B2|Baseline|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
991293|NCT00836641|B1|Baseline|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
991294|NCT00836641|P2|Participant Flow|Group B: Sequential Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
991295|NCT00836641|P1|Participant Flow|Group A: Sequential Pneumococcal Immunzation (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
991296|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
991297|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
991298|NCT00836641|O2|Outcome|Group B Pneumococcal Immunization (10 mo)|one dose of pneumococcal conjugate vaccine followed after 10 months by one dose of pneumococcal polysaccharide vaccine
991299|NCT00836641|O1|Outcome|Group A Pneumococcal Immunization (2 mo)|one dose of pneumococcal conjugate vaccine followed after 2 months by one dose of pneumococcal polysaccharide vaccine
991300|NCT00836641|E1|Reported Event|Overall Study Population|the whole study population was observed for adverse events.
991301|NCT00836498|B3|Baseline|Total|Total of all reporting groups
991302|NCT00836498|B2|Baseline|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991303|NCT00836498|B1|Baseline|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991304|NCT00836498|P2|Participant Flow|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991305|NCT00836498|P1|Participant Flow|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991306|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991307|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991308|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991309|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991310|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991311|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991312|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991313|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991314|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991316|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991317|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991318|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991319|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991320|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991321|NCT00836498|O1|Outcome|RotaTeq|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991322|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991323|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991324|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991325|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991326|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991327|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991328|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991329|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991330|NCT00836498|O2|Outcome|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991331|NCT00836498|O1|Outcome|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991332|NCT00836498|E2|Reported Event|Placebo|Three dose regimen of matching placebo. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991333|NCT00836498|E1|Reported Event|RotaTeq™|Three dose regimen of RotaTeq™. Vaccination 1 administered on Day 1, Vaccination 2 administered 28-42 days after Vaccination 1, and Vaccination 3 administered 28-42 days after Vaccination 2.
991334|NCT00836472|B3|Baseline|Total|Total of all reporting groups
991335|NCT00836472|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
991336|NCT00836472|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
991337|NCT00836472|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
991338|NCT00836472|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
991339|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991340|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
991341|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991342|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
991343|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991344|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
991345|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991346|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
991347|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991348|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
991349|NCT00836472|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991350|NCT00836472|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in either period
991351|NCT00836433|B3|Baseline|Total|Total of all reporting groups
991392|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
991393|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
991394|NCT00836355|E4|Reported Event|Control|
991352|NCT00836433|B2|Baseline|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991353|NCT00836433|B1|Baseline|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991354|NCT00836433|P2|Participant Flow|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991355|NCT00836433|P1|Participant Flow|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991356|NCT00836433|O2|Outcome|CONNECT and FALLS|"CONNECT intervention on relationship-building and communication. Includes 2 in-class session, group mapping, individual relationship mapping, coaching sessions.~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991357|NCT00836433|O1|Outcome|FALLS Only|"Traditional falls educational intervention, including self-study modules, audit and feedback, falls team training, academic detailing, and toolkit.~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991358|NCT00836433|O2|Outcome|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991359|NCT00836433|O1|Outcome|FALLS|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991360|NCT00836433|E2|Reported Event|CONNECT + FALLS|"CONNECT intervention on relationship-building and communication~CONNECT educational intervention: Training program for staff to improve communication with a more dense network of co-workers, in order to improve resident problem-solving~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991361|NCT00836433|E1|Reported Event|FALLS Only|"Traditional falls educational intervention~FALLS educational intervention: Traditional falls quality improvement education program including online modules, audit and feedback, and academic detailing sessions"
991362|NCT00836407|B3|Baseline|Total|Total of all reporting groups
991363|NCT00836407|B2|Baseline|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
991364|NCT00836407|B1|Baseline|Arm 1: Ipilimumab Alone|Ipilimumab alone
991365|NCT00836407|P2|Participant Flow|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
991366|NCT00836407|P1|Participant Flow|Arm 1: Ipilimumab Alone|Ipilimumab alone
991367|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
991368|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
991369|NCT00836407|O2|Outcome|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
991370|NCT00836407|O1|Outcome|Arm 1: Ipilimumab Alone|Ipilimumab alone
991371|NCT00836407|E2|Reported Event|Arm 2: Ipilimumab + Pancreatic Cancer Vaccine|Ipilimumab + Pancreatic Cancer Vaccine
991372|NCT00836407|E1|Reported Event|Arm 1: Ipilimumab Alone|Ipilimumab alone
991373|NCT00836355|B5|Baseline|Total|Total of all reporting groups
991374|NCT00836355|B4|Baseline|Control|
991375|NCT00836355|B3|Baseline|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
991376|NCT00836355|B2|Baseline|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
991377|NCT00836355|B1|Baseline|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
991378|NCT00836355|P4|Participant Flow|Control|
991379|NCT00836355|P3|Participant Flow|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
991380|NCT00836355|P2|Participant Flow|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
991381|NCT00836355|P1|Participant Flow|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
991382|NCT00836355|O4|Outcome|Control|
991383|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
991384|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
991385|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
991386|NCT00836355|O4|Outcome|Control|
991387|NCT00836355|O3|Outcome|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
991388|NCT00836355|O2|Outcome|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
991389|NCT00836355|O1|Outcome|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
991390|NCT00836355|O4|Outcome|Control|
991395|NCT00836355|E3|Reported Event|Enoxaparin and Minocycline|"Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later~Minocycline: 200 mg orally once daily for 5 days"
991396|NCT00836355|E2|Reported Event|Minocycline|"Minocycline 200 mg orally once daily for 5 days~Minocycline: 200 mg orally once daily for 5 days"
991397|NCT00836355|E1|Reported Event|Enoxaparin|Enoxaparin: 2 (or 3) intravenous doses, the first on study entry, the last 24 hours later
991398|NCT00836342|B4|Baseline|Total|Total of all reporting groups
991399|NCT00836342|B3|Baseline|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
991400|NCT00836342|B2|Baseline|Previous History of BCC|Participants had previous history of basal cell carcinoma
991401|NCT00836342|B1|Baseline|Previous History of SCC|Participants had previous history of squamous cell carcinoma
991402|NCT00836342|P3|Participant Flow|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
991403|NCT00836342|P2|Participant Flow|Previous History of BCC|Participants had previous history of basal cell carcinoma
991404|NCT00836342|P1|Participant Flow|Previous History of SCC|Participants had previous history of squamous cell carcinoma
991405|NCT00836342|O2|Outcome|Control Group|Participants had no history of previous squamous cell carcinoma or basal cell carcinoma
991406|NCT00836342|O1|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
991407|NCT00836342|O2|Outcome|Previous History of BCC|Participants had previous history of basal cell carcinoma
991408|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
991409|NCT00836342|O2|Outcome|Control Group|Participants had no previous history or squamous cell carcinoma or basal cell carcinoma
991410|NCT00836342|O1|Outcome|Previous History of SCC|Participants had previous history of squamous cell carcinoma
991411|NCT00836342|E3|Reported Event|Control Group|Participants had no history of squamous cell carcinoma or basal cell carcinoma
991412|NCT00836342|E2|Reported Event|Previous History of BCC|Participants had previous history of basal cell carcinoma
991413|NCT00836342|E1|Reported Event|Previous History of SCC|Participants had previous history of squamous cell carcinoma
991414|NCT00836277|B1|Baseline|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991415|NCT00836277|P1|Participant Flow|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991416|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991417|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991418|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991419|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991420|NCT00836277|O1|Outcome|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991421|NCT00836277|E1|Reported Event|Irinotecan + Panitumumab|Participants with a diagnosis of locally recurrent and/or metastatic esophageal adenocarcinoma treated with panitumumab 9 mg/kg on day 1 and irinotecan 100 mg/m^2 on days 1 and 8 of each 21 day cycle to a maximum of 6 cycles.
991422|NCT00836095|B3|Baseline|Total|Total of all reporting groups
991423|NCT00836095|B2|Baseline|Proseal LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
991424|NCT00836095|B1|Baseline|Supreme LMA|"The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant."
991425|NCT00836095|P2|Participant Flow|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
991426|NCT00836095|P1|Participant Flow|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
991427|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
991428|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
991467|NCT00835991|P1|Participant Flow|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
991429|NCT00836095|O2|Outcome|Proseal LMA|"Proseal laryngeal mask airway: The Proseal is a multiple use, variant of the laryngeal mask airway~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
991430|NCT00836095|O1|Outcome|Supreme LMA|"Supreme Laryngeal mask airway: The Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. The airway device will be blindly inserted by an experienced attending anesthesiologist."
991431|NCT00836095|E2|Reported Event|Proseal LMA|"Proseal is a multiple use, variant of the laryngeal mask airway.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Proseal laryngeal mask airway: Proseal is a multiple use, variant of the laryngeal mask airway"
991432|NCT00836095|E1|Reported Event|Supreme LMA|"Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant.~The choice of the airway device will be randomized by opening a sealed envelope immediately before induction. Both airway devices will be blindly inserted by an experienced attending anesthesiologist.~Supreme Laryngeal mask airway: Supreme Laryngeal mask airway is a new, single use laryngeal mask airway variant"
991433|NCT00836056|B3|Baseline|Total|Total of all reporting groups
991434|NCT00836056|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
991435|NCT00836056|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
991436|NCT00836056|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
991437|NCT00836056|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
991438|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
991439|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
991440|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
991441|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
991442|NCT00836056|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
991443|NCT00836056|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
991444|NCT00836017|B1|Baseline|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991445|NCT00836017|P1|Participant Flow|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991446|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991447|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991448|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991449|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991450|NCT00836017|O1|Outcome|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991451|NCT00836017|E1|Reported Event|BOTOX®|Patients received BOTOX® (onabotulinumtoxinA) treatment as standard of care in clinical practice as prescribed by the physician. No intervention was administered as part of the study.
991452|NCT00836004|B3|Baseline|Total|Total of all reporting groups
991453|NCT00836004|B2|Baseline|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
991454|NCT00836004|B1|Baseline|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
991455|NCT00836004|P2|Participant Flow|Cleocin® (Reference) First|Cleocin® 300 mg Capsule (reference) dosed in first period followed by Clindamycin 300 mg Capsule (test) dosed in second period
991456|NCT00836004|P1|Participant Flow|Clindamycin (Test) First|Clindamycin 300 mg Capsule (test) dosed in first period followed by Cleocin® 300 mg Capsule (reference) dosed in second period
991457|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
991458|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
991459|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
991460|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
991461|NCT00836004|O2|Outcome|Cleocin®|Cleocin® 300 mg Capsule (reference) dosed in either period
991462|NCT00836004|O1|Outcome|Clindamycin|Clindamycin 300 mg Capsule (test) dosed in either period
991463|NCT00835991|B3|Baseline|Total|Total of all reporting groups
991464|NCT00835991|B2|Baseline|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
991465|NCT00835991|B1|Baseline|Glyburide Metformin (Test) First|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in first period followed by Glucovance® 5/500 mg Tablet (reference) dosed in second period
991466|NCT00835991|P2|Participant Flow|Glucovance® (Reference) First|Glucovance® 5/500 mg Tablet (reference) dosed in first period followed by Glyburide Metformin 5/500 mg Film-Coated Tablet (test) dosed in second period
996996|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
991468|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991469|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
991470|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991471|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
991472|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991473|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
991474|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991475|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
991476|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991477|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
991478|NCT00835991|O2|Outcome|Glucovance®|Glucovance® 5/500 mg Tablet (reference) dosed in either period
991479|NCT00835991|O1|Outcome|Glyburide Metformin|Glyburide Metformin 5/500 Film-Coated Tablet (test) dosed in either period
991480|NCT00835978|B5|Baseline|Total|Total of all reporting groups
991481|NCT00835978|B4|Baseline|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
991482|NCT00835978|B3|Baseline|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991483|NCT00835978|B2|Baseline|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991484|NCT00835978|B1|Baseline|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991485|NCT00835978|P4|Participant Flow|Discontinued Prior to Randomization|Participants who discontinued before they were randomized to any of the treatment or non-randomized arms.
991486|NCT00835978|P3|Participant Flow|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991487|NCT00835978|P2|Participant Flow|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991488|NCT00835978|P1|Participant Flow|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991489|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991490|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991491|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991492|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991493|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991619|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991620|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991625|NCT00835705|B2|Baseline|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
991494|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991495|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991496|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
991497|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991498|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991499|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991500|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991501|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991502|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991503|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991504|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991505|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991506|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991507|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991508|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991509|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991510|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991621|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991511|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991512|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991513|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
991514|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991515|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991516|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991517|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo[blinded therapy] 5 mg BID).
991518|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991519|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991520|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991521|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991522|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991523|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991524|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991623|NCT00835731|E1|Reported Event|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991525|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991526|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991527|NCT00835978|O3|Outcome|Non-randomized Arm (SA Population)|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991528|NCT00835978|O2|Outcome|Placebo Titration Arm (FA Population)|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991529|NCT00835978|O1|Outcome|Active Titration Arm (FA Population)|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991530|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991531|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991532|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991533|NCT00835978|O4|Outcome|All Participants|All enrolled participants (randomized and non-randomized)
991534|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991535|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991536|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991537|NCT00835978|O4|Outcome|All Participants|All enrolled participants (randomized and non-randomized)
991538|NCT00835978|O3|Outcome|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991539|NCT00835978|O2|Outcome|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991540|NCT00835978|O1|Outcome|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991541|NCT00835978|E4|Reported Event|Discontinued Prior to Randomization|Participants who were discontinued prior to randomization to either treatment or non-randomization arms.
991542|NCT00835978|E3|Reported Event|Non-randomized Arm|Participants not eligible for randomization were assigned to receive axitinib 5 mg BID or a reduced dose per the dose modification guideline. Dose titration was not permitted in this treatment arm.
991543|NCT00835978|E2|Reported Event|Placebo Titration Arm|Participants initially received axitinib 5mg BID + placebo (blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + placebo (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + placebo [blinded therapy] 5 mg BID).
991544|NCT00835978|E1|Reported Event|Active Titration Arm|Participants initially received axitinib 5 mg twice a day (BID) + axitinib(blinded therapy) 2 mg BID. After at least 2 consecutive weeks, participants satisfying the dose titration criteria had their dose level increased by one additional dose level, to axitinib 5 mg BID + axitinib (blinded therapy) 5 mg BID, unless otherwise contraindicated per the investigator’s clinical judgment. The maximum total daily dose was 10 mg BID (axitinib 5mg BID + axitinib [blinded therapy] 5 mg BID).
991545|NCT00835926|B3|Baseline|Total|Total of all reporting groups
991546|NCT00835926|B2|Baseline|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
991547|NCT00835926|B1|Baseline|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
991548|NCT00835926|P2|Participant Flow|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
991549|NCT00835926|P1|Participant Flow|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
991550|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
991551|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
991552|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
991553|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
991554|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
991555|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
991556|NCT00835926|O2|Outcome|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
991557|NCT00835926|O1|Outcome|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
991558|NCT00835926|E2|Reported Event|Fluzone® Vaccine Group 2|Participants were 60 years or older at enrollment in the study
991559|NCT00835926|E1|Reported Event|Fluzone® Vaccine Group 1|Participants were 18 to 59 years old at enrollment in the study
991560|NCT00835900|B3|Baseline|Total|Total of all reporting groups
991561|NCT00835900|B2|Baseline|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
991562|NCT00835900|B1|Baseline|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
991563|NCT00835900|P2|Participant Flow|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
991564|NCT00835900|P1|Participant Flow|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
991565|NCT00835900|O2|Outcome|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
991566|NCT00835900|O1|Outcome|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
991567|NCT00835900|O2|Outcome|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
991568|NCT00835900|O1|Outcome|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
991569|NCT00835900|E2|Reported Event|Standard Run-In|"The Standard run-in group received 3 weeks of placebo, followed by standard dosing: 1-week pre-TQD varenicline and 11-week post-TQD varenicline, totaling 12 weeks.~Both groups received brief cognitive-behavioral counseling."
991570|NCT00835900|E1|Reported Event|Extended Run-In|The Extended run-in group received 4 weeks of varenicline pre-TQD, then continued with standard (11 weeks) post-quit treatment.
991571|NCT00835861|B3|Baseline|Total|Total of all reporting groups
991572|NCT00835861|B2|Baseline|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
991573|NCT00835861|B1|Baseline|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone.
991574|NCT00835861|P2|Participant Flow|Insulin|Patients received standard diet and glycemic monitoring education. They were started on weight-based Regular and neutral protamine Hagedorn (NPH) insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Self-reported glucose values were reviewed during each clinic visit and insulin dosage was titrated to achieve optimal glycemic control with fasting values <90 and one hour post prandial values <130.
991575|NCT00835861|P1|Participant Flow|Metformin|Patients received standard diet and glucose self-monitoring education. Medication naive patients were initiated on Metformin 500 BID or were continued on their current dosage of Metformin if taking prior to pregnancy. Self-reported glucose values were reviewed during each clinic visit and Metformin dosage was titrated up to a maximum of 2250 mg/day as needed for glycemic control. Insulin was added to those not achieving glycemic control with Metformin alone
991624|NCT00835705|B3|Baseline|Total|Total of all reporting groups
991576|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991577|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991578|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991579|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991580|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991581|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991582|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991583|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991584|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991585|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991586|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991587|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991588|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991589|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991622|NCT00835731|E2|Reported Event|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991590|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991591|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991592|NCT00835861|O2|Outcome|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991593|NCT00835861|O1|Outcome|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991594|NCT00835861|E2|Reported Event|Insulin|Standard diet and glycemic monitoring education. Initiated on weight-based Regular and NPH insulin at a total dosage of 0.7units/kg in the first trimester or 0.8units/kg in the second trimester divided as 2/3 of the total dosage (with 2/3 given as NPH and 1/3 given as Regular) administered before breakfast and 1/3 of the total dosage (with 1/2 given as NPH and 1/2 given as Regular) administered with dinner. Dosage titrated during visits to achieve optimal glycemic control with fasting values <90 mg/dL and 1-hr post prandial values < 130 mg/dL.
991595|NCT00835861|E1|Reported Event|Metformin|Standard diet and glucose self-monitoring education. Initiated on Metformin 500 BID if medication naïve, or continued on their current dosage of Metformin if taking it prior to pregnancy. Dosage titrated to a maximum of 2250 mg/day based on review of self-reported fasting and post prandial glucose values during visits. .NPH Insulin treatment added for those unable to achieve glycemic control with Metformin alone.
991596|NCT00835796|B3|Baseline|Total|Total of all reporting groups
991597|NCT00835796|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
991598|NCT00835796|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
991599|NCT00835796|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
991600|NCT00835796|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
991601|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
991602|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
991603|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
991604|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
991605|NCT00835796|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
991606|NCT00835796|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
991607|NCT00835731|B3|Baseline|Total|Total of all reporting groups
991608|NCT00835731|B2|Baseline|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991609|NCT00835731|B1|Baseline|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991610|NCT00835731|P2|Participant Flow|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991611|NCT00835731|P1|Participant Flow|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991612|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991613|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991614|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991615|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991616|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991617|NCT00835731|O1|Outcome|Misoprostol|"400mcg buccal misoprostol~misoprostol : 400mcg misoprostol, buccal administration, 1 time dosing 3-4 hours before abortion by D&E"
991618|NCT00835731|O2|Outcome|Synthetic Osmotic Dilator|"Dilapan-S, control: vitamin B-12 administered sublingually~Dilapan-S, vitamin B-12 : One Dilapan-S rod placed in the cervix 3-4 hours before abortion by D&E.~Control: 1000mcg vitamin B-12, buccal administration 3-4 hours before abortion by D&E"
991626|NCT00835705|B1|Baseline|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
991627|NCT00835705|P2|Participant Flow|Augmentin® (Reference) First|Augmentin® 400/57 mg chewable tablet (reference) dosed in first period followed by Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in second period
991628|NCT00835705|P1|Participant Flow|Amoxicillin Clavulanic Acid (Test) First|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in first period followed by Augmentin® 400/57 mg chewable tablet (reference) dosed in second period
991629|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991630|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991631|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991632|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991633|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991634|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991635|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991636|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991637|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991638|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991639|NCT00835705|O2|Outcome|Augmentin®|Augmentin® 400/57 mg chewable tablet (reference) dosed in either period
991640|NCT00835705|O1|Outcome|Amoxicillin Clavulanic Acid|Amoxicillin-Clavulanic Acid 400/57 mg chewable tablet (test) dosed in either period
991641|NCT00835692|B3|Baseline|Total|Total of all reporting groups
991642|NCT00835692|B2|Baseline|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
991643|NCT00835692|B1|Baseline|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
991644|NCT00835692|P2|Participant Flow|Biaxin® (Reference) First|Biaxin® 500 mg Tablet (reference) dosed in first period followed by Clarithromycin 500 mg Tablet dosed in second period
991645|NCT00835692|P1|Participant Flow|Clarithromycin (Test) First|Clarithromycin 500 mg Tablet (test) dosed in first period followed by Biaxin® 500 mg Tablet (reference) dosed in second period
991646|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
991647|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
991648|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
991649|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
991650|NCT00835692|O2|Outcome|Biaxin®|Biaxin® 500 mg Tablet (reference) dosed in either period
991651|NCT00835692|O1|Outcome|Clarithromycin|Clarithromycin 500 mg Tablet (test) dosed in either period
991652|NCT00835679|B5|Baseline|Total|Total of all reporting groups
991653|NCT00835679|B4|Baseline|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
991654|NCT00835679|B3|Baseline|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
991655|NCT00835679|B2|Baseline|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
991656|NCT00835679|B1|Baseline|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
991657|NCT00835679|P4|Participant Flow|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
991658|NCT00835679|P3|Participant Flow|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
991659|NCT00835679|P2|Participant Flow|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
991660|NCT00835679|P1|Participant Flow|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
991661|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
991662|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
991663|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
991664|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
991665|NCT00835679|O4|Outcome|Cetuximab + Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
991666|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15 1-14.
991667|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
991668|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
991669|NCT00835679|O4|Outcome|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
991670|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
991671|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
991672|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
991673|NCT00835679|O4|Outcome|Cetuximab +Dasatinib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
991674|NCT00835679|O3|Outcome|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
991675|NCT00835679|O2|Outcome|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
991676|NCT00835679|O1|Outcome|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
991677|NCT00835679|E4|Reported Event|Cetuximab + Dasatiib Cohort D|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8 AND dasatinib 100 mg orally once daily on days 1-14. Definitive surgical resection of liver metastases will take place on day 15
991678|NCT00835679|E3|Reported Event|Dasatinib Cohort C|Patients receive dasatinib 100 mg orally once daily on days 1-14.Definitive surgical resection of liver metastases will take place on day 15
991679|NCT00835679|E2|Reported Event|Cetuximab Cohort B|Patients receive 400 mg/m2 cetuximab intravenously (IV) over 120 minutes on day 1 and 250 mg/m2 cetuximab IV over 60-120 minutes on day 8. Definitive surgical resection of liver metastases will take place on day 15
991680|NCT00835679|E1|Reported Event|No Treatment Cohort A|Patients receive no systemic neoadjuvant therapy between enrollment and the time of definitive surgical resection of liver metastases. Liver biopsies were performed at surgery since this cohort received no systemic therapy.
991681|NCT00835666|B3|Baseline|Total|Total of all reporting groups
991682|NCT00835666|B2|Baseline|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
991683|NCT00835666|B1|Baseline|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
991684|NCT00835666|P2|Participant Flow|Proscar® (Reference) First|Proscar® 5 mg Tablet (reference) dosed in first period followed by Finasteride 5 mg Tablet (test) dosed in second period
991685|NCT00835666|P1|Participant Flow|Finasteride (Test) First|Finasteride 5 mg Tablet (test) dosed in first period followed by Proscar® 5 mg Tablet (reference) dosed in second period
991686|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
991687|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
991688|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
991689|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
991690|NCT00835666|O2|Outcome|Proscar®|Proscar® 5 mg Tablet (reference) dosed in either period
991691|NCT00835666|O1|Outcome|Finasteride|Finasteride 5 mg Tablet (test) dosed in either period
991692|NCT00835640|B3|Baseline|Total|Total of all reporting groups
991693|NCT00835640|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
991694|NCT00835640|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
991695|NCT00835640|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
991696|NCT00835640|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
991697|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
991844|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991698|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
991699|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
991700|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
991701|NCT00835640|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
991702|NCT00835640|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
991703|NCT00835614|B3|Baseline|Total|Total of all reporting groups
991704|NCT00835614|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
991705|NCT00835614|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
991706|NCT00835614|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
991707|NCT00835614|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
991708|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
991709|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
991710|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
991711|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
991712|NCT00835614|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
991713|NCT00835614|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
991714|NCT00835588|B3|Baseline|Total|Total of all reporting groups
991715|NCT00835588|B2|Baseline|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
991716|NCT00835588|B1|Baseline|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
991717|NCT00835588|P2|Participant Flow|Protonix® (Reference) First|Protonix 40 mg DR Tablet (reference) dosed in first period followed by Pantoprazole Sodium 40 mg DR Tablet (test) dosed in second period
991718|NCT00835588|P1|Participant Flow|Pantoprazole (Test) First|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in first period followed by Protonix® 40 mg DR Tablet (reference) dosed in second period
991719|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
991720|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
991721|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
991722|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
991723|NCT00835588|O2|Outcome|Protonix®|Protonix 40 mg DR Tablet (reference) dosed in either period
991724|NCT00835588|O1|Outcome|Pantoprazole|Pantoprazole Sodium 40 mg DR Tablet (test) dosed in either period
991725|NCT00835575|B3|Baseline|Total|Total of all reporting groups
991726|NCT00835575|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
991727|NCT00835575|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
991728|NCT00835575|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
991729|NCT00835575|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
991730|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
991731|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
991732|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
991733|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
991734|NCT00835575|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
991735|NCT00835575|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
991736|NCT00835549|B3|Baseline|Total|Total of all reporting groups
991737|NCT00835549|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
991738|NCT00835549|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
991739|NCT00835549|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspension test product dosed in the second period.
991740|NCT00835549|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
991741|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
991742|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
991743|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
991744|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
991745|NCT00835549|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
991746|NCT00835549|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
991747|NCT00835536|B3|Baseline|Total|Total of all reporting groups
991748|NCT00835536|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
991749|NCT00835536|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
991750|NCT00835536|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
991751|NCT00835536|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
991752|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
991753|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
991754|NCT00835536|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
991755|NCT00835536|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
991756|NCT00835510|B4|Baseline|Total|Total of all reporting groups
991757|NCT00835510|B3|Baseline|Vehicle|Butenafine vehicle applied for 7 days
991758|NCT00835510|B2|Baseline|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991759|NCT00835510|B1|Baseline|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991760|NCT00835510|P3|Participant Flow|Vehicle|Butenafine vehicle applied for 7 days
991761|NCT00835510|P2|Participant Flow|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991762|NCT00835510|P1|Participant Flow|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991763|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
991764|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991765|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991766|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
991767|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991768|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991769|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
991770|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991771|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991772|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
991773|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991774|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991775|NCT00835510|O3|Outcome|Vehicle|Butenafine vehicle applied for 7 days
991776|NCT00835510|O2|Outcome|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991777|NCT00835510|O1|Outcome|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991778|NCT00835510|E3|Reported Event|Vehicle|Butenafine vehicle applied for 7 days
991779|NCT00835510|E2|Reported Event|Lotrimin Ultra (Butenafine) 1%|Lotrimin Ultra (butenafine) applied for 7 days
991780|NCT00835510|E1|Reported Event|Butenafine Cream 1% (Taro)|Butenafine cream manufactured by Taro applied for 7 days
991781|NCT00835497|B3|Baseline|Total|Total of all reporting groups
991782|NCT00835497|B2|Baseline|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
991783|NCT00835497|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
991784|NCT00835497|P2|Participant Flow|Metaglip® (Reference) First|Metaglip® 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
991785|NCT00835497|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip® 5/500 mg Tablet (reference) dosed in second period
991786|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
991787|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
991788|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
991789|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
991790|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
991791|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
991792|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
991793|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
991794|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
991795|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
991796|NCT00835497|O2|Outcome|Metaglip®|Metaglip® 5/500 mg Tablet (reference) dosed in either period
991797|NCT00835497|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
991798|NCT00835484|B3|Baseline|Total|Total of all reporting groups
991799|NCT00835484|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
991800|NCT00835484|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
991801|NCT00835484|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
991802|NCT00835484|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
991803|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
991804|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
991805|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
991806|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
991807|NCT00835484|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
991808|NCT00835484|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
991809|NCT00835406|B3|Baseline|Total|Total of all reporting groups
991810|NCT00835406|B2|Baseline|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
991811|NCT00835406|B1|Baseline|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
991812|NCT00835406|P2|Participant Flow|Fosamax® First|70 mg Fosamax® Tablets reference product dosed in first period followed by 70 mg Alendronate Sodium Tablets test product dosed in second period.
991813|NCT00835406|P1|Participant Flow|Alendronate Sodium First|70 mg Alendronate Sodium Tablets test product dosed in first period followed by 70 mg Fosamax® Tablets reference product dosed in second period
991814|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
991815|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
991816|NCT00835406|O2|Outcome|Fosamax®|70 mg Fosamax® Tablets reference product dosed in either period
991817|NCT00835406|O1|Outcome|Alendronate Sodium|70 mg Alendronate Sodium Tablets test product dosed in either period
991818|NCT00835380|B1|Baseline|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
991819|NCT00835380|P1|Participant Flow|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
991820|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
991821|NCT00835380|O1|Outcome|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
991822|NCT00835380|E1|Reported Event|VAQTA™|Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
991823|NCT00835367|B3|Baseline|Total|Total of all reporting groups
991824|NCT00835367|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
991825|NCT00835367|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
991826|NCT00835367|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test)dosed in second period
991827|NCT00835367|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test)dosed in first period followed by Lotrel® 10/20 mg capsule (reference) dosed in second period
991828|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991829|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991830|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991831|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991832|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991833|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991834|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991835|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991836|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991837|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991838|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991839|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991840|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991841|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991842|NCT00835367|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
991843|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991845|NCT00835367|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test)dosed in either period
991846|NCT00835354|B3|Baseline|Total|Total of all reporting groups
991847|NCT00835354|B2|Baseline|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
991848|NCT00835354|B1|Baseline|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
991849|NCT00835354|P2|Participant Flow|Cefzil® (Reference) First|250mg/5mL Cefzil® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefprozil for Oral Suspension test product dosed in the second period.
991850|NCT00835354|P1|Participant Flow|Cefprozil (Test) First|250mg/5mL Cefprozil for Oral Suspension test product dosed in first period followed by 250mg/5mL Cefzil® for Oral Suspension reference product dosed in the second period.
991851|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
991852|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
991853|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
991854|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
991855|NCT00835354|O2|Outcome|Cefzil® (Reference)|250mg/5mL Cefzil® for Oral Suspension reference product dosed in either period.
991856|NCT00835354|O1|Outcome|Cefprozil (Test)|250mg/5mL Cefprozil for Oral Suspension test product dosed in either period.
991857|NCT00835341|B3|Baseline|Total|Total of all reporting groups
991858|NCT00835341|B2|Baseline|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
991859|NCT00835341|B1|Baseline|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
991860|NCT00835341|P2|Participant Flow|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
991861|NCT00835341|P1|Participant Flow|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
991862|NCT00835341|O2|Outcome|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
991863|NCT00835341|O1|Outcome|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
991864|NCT00835341|E2|Reported Event|p16-unmethylated|patients with mild or moderate oral epithelial dysplasia NOT containing methylated p16 CpG island.
991865|NCT00835341|E1|Reported Event|p16-methylated|patients with mild or moderate oral epithelial dysplasia containing methylated p16 CpG island.
991866|NCT00835276|B3|Baseline|Total|Total of all reporting groups
991867|NCT00835276|B2|Baseline|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
991868|NCT00835276|B1|Baseline|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
991869|NCT00835276|P2|Participant Flow|Allegra® First|180 mg Allegra® Tablets reference product dosed in first period followed by 180 mg Fexofenadine Hydrochloride Tablets test product dosed in the second period.
991870|NCT00835276|P1|Participant Flow|Fexofenadine Hydrochloride First|180 mg Fexofenadine Hydrochloride Tablets test product dosed in first period followed by 180 mg Allegra® Tablets reference product dosed in the second period.
991871|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
991872|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
991873|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
991874|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
991875|NCT00835276|O2|Outcome|Allegra®|180 mg Allegra® Tablets reference product dosed in either period.
991876|NCT00835276|O1|Outcome|Fexofenadine Hydrochloride|180 mg Fexofenadine Hydrochloride Tablets test product dosed in either period.
991877|NCT00835263|B3|Baseline|Total|Total of all reporting groups
991878|NCT00835263|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
991879|NCT00835263|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
991880|NCT00835263|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
991881|NCT00835263|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
991882|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
991883|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
991884|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
991885|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
991886|NCT00835263|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
991887|NCT00835263|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
991888|NCT00835237|B3|Baseline|Total|Total of all reporting groups
991889|NCT00835237|B2|Baseline|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991890|NCT00835237|B1|Baseline|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991891|NCT00835237|P2|Participant Flow|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991892|NCT00835237|P1|Participant Flow|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
1031586|NCT00737737|B3|Baseline|Total|Total of all reporting groups
991893|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991894|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991895|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991896|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991897|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991898|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991899|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991900|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991901|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991902|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991903|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991904|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991905|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991906|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991907|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991908|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991909|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991910|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991911|NCT00835237|O2|Outcome|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991912|NCT00835237|O1|Outcome|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991913|NCT00835237|E2|Reported Event|Decavac Group|Subjects received a single dose of Decavac™ (tetanus and diphtheria toxoids vaccine)
991914|NCT00835237|E1|Reported Event|Boostrix Group|Subjects received a single dose of Boostrix™ (tetanus toxoids, reduced diphtheria toxoids and acellular pertussis vaccine)
991915|NCT00835224|B1|Baseline|All Participants|All participants were studied on three laboratory visits and underwent seated blood pressure assessment before and after administration of Midodrine, L-NAME or placebo, which were given in random order.
991916|NCT00835224|P1|Participant Flow|All Participants|All Participants visited the laboratory on 3 occasions for a 4-5 hour observation of blood pressure following administration of a non-selective inhibitor of nitric oxide synthase (L-NAME) an alpha-agonist (midodrine) or placebo. The interventions were administered in random order on separate laboratory visits.
991917|NCT00835224|O6|Outcome|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
991918|NCT00835224|O5|Outcome|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
991919|NCT00835224|O4|Outcome|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
991920|NCT00835224|O3|Outcome|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
991921|NCT00835224|O2|Outcome|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
991922|NCT00835224|O1|Outcome|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
991923|NCT00835224|E6|Reported Event|Arm 3B|Non disabled participants seated systolic blood pressure for 3 hours after administration of no drug.
991924|NCT00835224|E5|Reported Event|Arm 3A|Spinal cord injured participants systolic blood pressure for 3 hours after administration of no drug
991925|NCT00835224|E4|Reported Event|Arm 2B|Non disabled participants seated systolic blood pressure for 3 hours after administration of midodrine.
991926|NCT00835224|E3|Reported Event|Arm 2A|Spinal cord injured participants seated systolic Blood Pressure for 3 hours after administration of midodrine or
991927|NCT00835224|E2|Reported Event|Arm 1B|Non disabled participants seated systolic blood pressure for 3 hours after administration of a nitric oxide synthase inhibitor (L-NAME)
991928|NCT00835224|E1|Reported Event|Arm 1A|Spinal Cord Injured participants - Seated blood pressure after administration of a nitric oxide synthase inhibitor (L-NAME)over the course of 3 hours
991929|NCT00835211|B3|Baseline|Total|Total of all reporting groups
991930|NCT00835211|B2|Baseline|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
991931|NCT00835211|B1|Baseline|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
991932|NCT00835211|P2|Participant Flow|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in first period followed by Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in second period
991933|NCT00835211|P1|Participant Flow|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in first period followed by DDAVP® 4 x 0.2 mg Tablet (reference) dosed in second period
991934|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
991935|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
991936|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
991937|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
991938|NCT00835211|O2|Outcome|DDAVP®|DDAVP® 4 x 0.2 mg Tablet (reference) dosed in either period
991939|NCT00835211|O1|Outcome|Desmopressin Acetate|Desmopressin Acetate 4 x 0.2 mg Tablet (test) dosed in either period
991940|NCT00835198|B3|Baseline|Total|Total of all reporting groups
991941|NCT00835198|B2|Baseline|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
991942|NCT00835198|B1|Baseline|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
991943|NCT00835198|P2|Participant Flow|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
991944|NCT00835198|P1|Participant Flow|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
991945|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
991946|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
991947|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
991948|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
991949|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
991950|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
991951|NCT00835198|O2|Outcome|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
991952|NCT00835198|O1|Outcome|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
991953|NCT00835198|E2|Reported Event|Dapsone Gel 5% and Tretinoin Gel 0.025%|Dapsone gel 5% and Tretinoin gel 0.025%
991954|NCT00835198|E1|Reported Event|Tretinoin Gel 0.025%|Tretinoin gel 0.025%
991955|NCT00835185|B1|Baseline|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991956|NCT00835185|P1|Participant Flow|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 milligrams (mg) IMC-11F8 intravenous (IV) infusion over 50 minutes~85 milligrams per meter square (mg/m²) oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent or until other criteria for treatment discontinuation were met."
991957|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991958|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991959|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991960|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991961|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991999|NCT00835146|P2|Participant Flow|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
992390|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992317|NCT00833703|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
991962|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991963|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991964|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
991965|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
991966|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
991967|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
991968|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of Cycle 1, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision or until other criteria for treatment discontinuation were met."
991969|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991970|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991971|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991995|NCT00835159|E1|Reported Event|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
991996|NCT00835146|B3|Baseline|Total|Total of all reporting groups
991972|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991973|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991974|NCT00835185|O1|Outcome|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes~85 mg/m² oxaliplatin IV infusion over 2 hours~400 mg/m² folinic acid~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m² All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991975|NCT00835185|E1|Reported Event|IMC-11F8 (Necitumumab) + mFOLFOX-6|"On Day 1 of each 2-week cycle, each participant received IMC-11F8 (necitumumab) in combination with the mFOLFOX-6 regimen (oxaliplatin/5-FU/FA) in the order shown:~800 mg IMC-11F8 IV infusion over 50 minutes;~85 mg/m² oxaliplatin IV infusion over 2 hours;~400 mg/m² folinic acid;~400 mg/m² 5-FU as an IV bolus injection; and immediately followed by~A 46-hour continuous IV infusion of 5-FU at 2400 mg/m². All treatments were administered every 2 weeks until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent, investigator decision, or until other criteria for treatment discontinuation were met."
991976|NCT00835172|B3|Baseline|Total|Total of all reporting groups
991977|NCT00835172|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
991978|NCT00835172|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
991979|NCT00835172|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
991980|NCT00835172|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
991981|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
991982|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
991983|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
991984|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
991985|NCT00835172|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
991986|NCT00835172|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
991987|NCT00835159|B3|Baseline|Total|Total of all reporting groups
991988|NCT00835159|B2|Baseline|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
991989|NCT00835159|B1|Baseline|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
991990|NCT00835159|P2|Participant Flow|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
991991|NCT00835159|P1|Participant Flow|Rivastigmine 5-cm2 Transdermal Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a rivastigmine 5-cm2 transdermal patch
991992|NCT00835159|O2|Outcome|Placebo Patch|Eligible patients received a placebo patch
991993|NCT00835159|O1|Outcome|Rivastigmine Patch|Eligible patients received a rivastigmine 5-cm2 transdermal patch
991994|NCT00835159|E2|Reported Event|Placebo Patch|Only patients at risk for developing POD were considered for recruitment. That risk was based on the presence of at least one of five predictive factors: (1) preoperative cognitive impairment (Mini mental state examination (MMSE)<24); (2) advanced age (>70 years); (3) preoperative use of psychoactive drugs; (4) history of prior delirium; and/or (5) severe illness or comorbidity. Eligible patients received a placebo patch.
991997|NCT00835146|B2|Baseline|Reference (Copegus®) First|200 mg Copegus® Tablets reference product dosed in first period followed by 200 mg Ribavirin Tablets test product dosed in the second period.
991998|NCT00835146|B1|Baseline|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
992000|NCT00835146|P1|Participant Flow|Test (Ribavirin) First|200 mg Ribavirin Tablets test product dosed in first period followed by 200 mg Copegus® Tablets reference product dosed in the second period.
992001|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
992002|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
992003|NCT00835146|O2|Outcome|Reference (Copegus®)|200 mg Copegus® Tablets reference product dosed in either period.
992004|NCT00835146|O1|Outcome|Test (Ribavirin)|200 mg Ribavirin Tablets test product dosed in either period.
992005|NCT00835120|B1|Baseline|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992006|NCT00835120|P1|Participant Flow|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992007|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992008|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992009|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992010|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992011|NCT00835120|O1|Outcome|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992012|NCT00835120|E1|Reported Event|Pioglitazone|"Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes~Pioglitazone: An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day."
992013|NCT00835081|B3|Baseline|Total|Total of all reporting groups
992014|NCT00835081|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
992015|NCT00835081|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
992016|NCT00835081|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
992017|NCT00835081|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
992018|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
992019|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
992020|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
992021|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
992022|NCT00835081|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
992023|NCT00835081|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
992024|NCT00835068|B3|Baseline|Total|Total of all reporting groups
992025|NCT00835068|B2|Baseline|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
992026|NCT00835068|B1|Baseline|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992027|NCT00835068|P2|Participant Flow|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
992028|NCT00835068|P1|Participant Flow|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992029|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992030|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992031|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992068|NCT00835003|B3|Baseline|Total|Total of all reporting groups
996997|NCT00823043|O1|Outcome|Timolol Hemihydrate|
992032|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992033|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
992034|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992035|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992036|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992037|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
992038|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992039|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
992040|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992041|NCT00835068|O2|Outcome|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
992042|NCT00835068|O1|Outcome|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992043|NCT00835068|E2|Reported Event|BeneFIX (Previously Untreated Participants)|Participants with hemophilia B who were previously untreated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection as per routine clinical practice and were observed for up to 5 years.
992044|NCT00835068|E1|Reported Event|BeneFIX (Previously Treated Participants)|Participants with hemophilia B who were previously treated with reformulated BeneFIX, received reformulated BeneFIX intravenous injection per routine clinical practice and were observed for up to 5 years.
992045|NCT00835042|B3|Baseline|Total|Total of all reporting groups
992046|NCT00835042|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
992047|NCT00835042|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
992048|NCT00835042|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide test product dosed in the second period.
992049|NCT00835042|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
992050|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992051|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992052|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992053|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992054|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992055|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992056|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992057|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992058|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992059|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992060|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992061|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992062|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992063|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992064|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992065|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992066|NCT00835042|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992067|NCT00835042|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992069|NCT00835003|B2|Baseline|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
992070|NCT00835003|B1|Baseline|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
992071|NCT00835003|P2|Participant Flow|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
992072|NCT00835003|P1|Participant Flow|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
992073|NCT00835003|O2|Outcome|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
992074|NCT00835003|O1|Outcome|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
992075|NCT00835003|E2|Reported Event|39 Weeks Group|"Elective caesarean section at 39 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 39 weeks and 3 days of gestation (+/- 2 days)"
992076|NCT00835003|E1|Reported Event|38 Weeks Group|"Elective caesarean section at 38 weeks and 3 days of gestation~Elective caesarean section: Procedure performed at 38 weeks and 3 days of gestation (+/- 2 days)"
992077|NCT00834990|B3|Baseline|Total|Total of all reporting groups
992078|NCT00834990|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
992079|NCT00834990|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
992080|NCT00834990|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
992081|NCT00834990|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
992082|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
992083|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
992084|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
992085|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
992086|NCT00834990|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
992087|NCT00834990|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
992088|NCT00834977|B3|Baseline|Total|Total of all reporting groups
992089|NCT00834977|B2|Baseline|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
992090|NCT00834977|B1|Baseline|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
992091|NCT00834977|P2|Participant Flow|Lotrel® (Reference) First|Lotrel® 10/20 mg capsule (reference) dosed in first period followed by Amlodipine Benazepril 10/20 mg capsule (test) dosed in second period
992092|NCT00834977|P1|Participant Flow|Amlodipine Benazepril (Test) First|Amlodipine Benazepril 10/20 mg capsule (test) dosed in first period followed by Lotrel® 10/20 mg capsule (reference) in second period
992093|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992094|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992095|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992096|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992097|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992098|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992099|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992100|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992101|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992102|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992103|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992104|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992105|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992106|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992107|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992108|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992109|NCT00834977|O2|Outcome|Lotrel®|Lotrel® 10/20 mg capsule (reference) dosed in either period
992110|NCT00834977|O1|Outcome|Amlodipine Benazepril|Amlodipine Benazepril 10/20 mg capsule (test) dosed in either period
992111|NCT00834964|B3|Baseline|Total|Total of all reporting groups
992112|NCT00834964|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
992113|NCT00834964|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
992114|NCT00834964|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
992115|NCT00834964|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
992116|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992117|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992118|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992119|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992120|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992121|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992122|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992123|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992124|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992125|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992126|NCT00834964|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992127|NCT00834964|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992128|NCT00834912|B7|Baseline|Total|Total of all reporting groups
992129|NCT00834912|B6|Baseline|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
992130|NCT00834912|B5|Baseline|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
992131|NCT00834912|B4|Baseline|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
992132|NCT00834912|B3|Baseline|Confab Fed / Confab Fasting / Trillium Fasting|Confab fed / Confab fasting / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
992133|NCT00834912|B2|Baseline|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
992134|NCT00834912|B1|Baseline|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
992135|NCT00834912|P6|Participant Flow|Trillium Fasting / Confab Fed / Confab Fasting|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
992136|NCT00834912|P5|Participant Flow|Trillium Fasting / Confab Fasting / Confab Fed|Trillium fasting / Confab fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
992137|NCT00834912|P4|Participant Flow|Confab Fed / Trillium Fasting / Confab Fasting|Confab fed / Trillium fasting / Confab fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 3.
992138|NCT00834912|P3|Participant Flow|Confab Fed / Confab Fasting / Trillium Fasting|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 1, 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 2, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
992170|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
992171|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
992139|NCT00834912|P2|Participant Flow|Confab Fasting / Trillium Fasting / Confab Fed|Confab fasting / Trillium fasting / Confab fed Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 2, and 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 3.
992140|NCT00834912|P1|Participant Flow|Confab Fasting / Confab Fed / Trillium Fasting|Confab fasting / Confab fed / Trillium fasting Group includes patients receiving once daily administration of the following Tramadol Hydrochloride (HCl) treatment: 1 x 300 mg tablet manufactured at Confab Laboratories, fasting condition in treatment period 1, 1x 300 mg tablet manufactured at Confab Laboratories, fed condition in treatment period 2, and 1 x 300 mg tablet manufactured at Trillium Healthcare Inc., fasting condition in treatment period 3.
992141|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
992142|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
992143|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
992144|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
992145|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
992146|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
992147|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
992148|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
992149|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
992150|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
992151|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
992152|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
992153|NCT00834912|O3|Outcome|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
992154|NCT00834912|O2|Outcome|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
992155|NCT00834912|O1|Outcome|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
992156|NCT00834912|E3|Reported Event|3: Tramadol HCl 300 mg (Trillium Healthcare) Fasting|Tramadol HCl 300 mg (Trillium Healthcare) fasting Group includes the treatment period 1 data from subjects in the Trillium fasting / Confab fasting / Confab fed and Trillium fasting / Confab fed / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Confab fed / Trillium fasting / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fed / Confab fasting / Trillium fasting sequences at period 3.
992157|NCT00834912|E2|Reported Event|2: Tramadol HCl 300 mg (Confab Laboratories) Fed|Tramadol HCl 300 mg (Confab Laboratories) fed Group includes the treatment period 1 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Confab fed / Trillium fasting / Confab fasting sequences at period 1, plus the treatment period 2 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fasting / Trillium fasting / Confab fed and Trillium fasting / Confab fasting / Confab fed sequences at period 3.
992158|NCT00834912|E1|Reported Event|1: Tramadol HCl 300 mg (Confab Laboratories) Fasting|Tramadol HCl 300 mg (Confab Laboratories) fasting Group includes the treatment period 1 data from subjects in the Confab fasting / Confab fed / Trillium fasting and Confab fasting / Trillium fasting / Confab fed sequences at period 1, plus the treatment period 2 data from subjects in the Confab fed / Confab fasting / Trillium fasting and Trillium fasting / Confab fasting / Confab fed sequences at period 2, and plus the treatment period 3 data from subjects in the Confab fed / Trillium fasting / Confab fasting and Trillium fasting / Confab fed / Confab fasting sequences at period 3.
992159|NCT00834899|B3|Baseline|Total|Total of all reporting groups
992160|NCT00834899|B2|Baseline|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
992161|NCT00834899|B1|Baseline|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
992162|NCT00834899|P2|Participant Flow|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
992163|NCT00834899|P1|Participant Flow|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
992164|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
992165|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
992166|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
992167|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
992168|NCT00834899|O2|Outcome|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
992169|NCT00834899|O1|Outcome|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
992172|NCT00834899|E2|Reported Event|Placebo|Patients randomized to the placebo arm received a saline solution delivered at a volume and rate identical to that of the active drug.
992173|NCT00834899|E1|Reported Event|Eptifibatide|Patients randomized to the eptifibatide arm received two 180 mcg/kg boluses of eptifibatide 10 minutes apart (i.e., a double bolus), followed by a continuous infusion at 2 mcg/kg/min for 6 hours.
992174|NCT00834886|B5|Baseline|Total|Total of all reporting groups
992175|NCT00834886|B4|Baseline|Placebo Melatonin and Placebo Light|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
992176|NCT00834886|B3|Baseline|Placebo Melatonin and Light Therapy|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992177|NCT00834886|B2|Baseline|Melatonin and Placebo Light|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
992178|NCT00834886|B1|Baseline|Melatonin and Light Therapy|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992179|NCT00834886|P4|Participant Flow|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
992180|NCT00834886|P3|Participant Flow|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992181|NCT00834886|P2|Participant Flow|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
992182|NCT00834886|P1|Participant Flow|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992183|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
992184|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992185|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
992186|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992187|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
992188|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992189|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
992190|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992191|NCT00834886|O4|Outcome|Placebo|"Placebo capsule + placebo light~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
992192|NCT00834886|O3|Outcome|Bright Light|"Bright light + placebo capsule~Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992193|NCT00834886|O2|Outcome|Melatonin|"Melatonin + placebo light~Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
992194|NCT00834886|O1|Outcome|Combination|"Bright light + melatonin~Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992195|NCT00834886|E4|Reported Event|Placebo|"Placebo melatonin + placebo light therapy~Placebo melatonin: Capsule 3 mg, rice flour~placebo light therapy: Placebo light"
992196|NCT00834886|E3|Reported Event|Bright Light|"Placebo melatonin: Capsule 3 mg, rice flour~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992197|NCT00834886|E2|Reported Event|Melatonin|"Melatonin: Capsules, 3 mg, once every night~placebo light therapy: Placebo light"
992198|NCT00834886|E1|Reported Event|Combination|"Melatonin: Capsules, 3 mg, once every night~Light therapy: Light therapy 10.000 lux by Miljølys AS"
992199|NCT00834873|B3|Baseline|Total|Total of all reporting groups
992200|NCT00834873|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
992201|NCT00834873|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
992202|NCT00834873|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
992203|NCT00834873|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period follwed by Coreg® 25 mg Tablet (reference) dosed in second period
992204|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
992205|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
992206|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
992207|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
992208|NCT00834873|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
992209|NCT00834873|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
992210|NCT00834808|B4|Baseline|Total|Total of all reporting groups
992211|NCT00834808|B3|Baseline|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992212|NCT00834808|B2|Baseline|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992213|NCT00834808|B1|Baseline|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992214|NCT00834808|P3|Participant Flow|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992215|NCT00834808|P2|Participant Flow|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992216|NCT00834808|P1|Participant Flow|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992217|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992218|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992219|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992220|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992221|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992222|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992223|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992224|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992225|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992226|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992227|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992228|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992229|NCT00834808|O3|Outcome|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992230|NCT00834808|O2|Outcome|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992231|NCT00834808|O1|Outcome|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992232|NCT00834808|E3|Reported Event|3: Tramadol HCl 300mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992233|NCT00834808|E2|Reported Event|2: Tramadol HCl 200mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992234|NCT00834808|E1|Reported Event|1: Tramadol HCl 100mg|"Single oral administration fasting conditions.~Randomization schedule based on a Latin Square design."
992235|NCT00834795|B3|Baseline|Total|Total of all reporting groups
992236|NCT00834795|B2|Baseline|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
992237|NCT00834795|B1|Baseline|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
992238|NCT00834795|P2|Participant Flow|Coreg® (Reference) First|Coreg® 25 mg Tablet (reference) dosed in first period followed by Carvedilol 25 mg Tablet (test) dosed in second period
992239|NCT00834795|P1|Participant Flow|Carvedilol (Test) First|Carvedilol 25 mg Tablet (test) dosed in first period followed by Coreg® 25 mg Tablet (reference) dosed in second period
992240|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
992241|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
992242|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
992243|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
992244|NCT00834795|O2|Outcome|Coreg®|Coreg® 25 mg Tablet (reference) dosed in either period
992245|NCT00834795|O1|Outcome|Carvedilol|Carvedilol 25 mg Tablet (test) dosed in either period
992246|NCT00833794|B3|Baseline|Total|Total of all reporting groups
992247|NCT00833794|B2|Baseline|2 Placebo|
992248|NCT00833794|B1|Baseline|1 Tramadol Once A Day|
992249|NCT00833794|P2|Participant Flow|2 Placebo|
992250|NCT00833794|P1|Participant Flow|1 Tramadol Once A Day|
992251|NCT00833794|O2|Outcome|2 Placebo|
992252|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992253|NCT00833794|O2|Outcome|2 Placebo|
992254|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992255|NCT00833794|O2|Outcome|2 Placebo|
992256|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992257|NCT00833794|O2|Outcome|2 Placebo|
992258|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992259|NCT00833794|O2|Outcome|2 Placebo|
992260|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992261|NCT00833794|O2|Outcome|2 Placebo|
992262|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992263|NCT00833794|O2|Outcome|2 Placebo|
992264|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992265|NCT00833794|O4|Outcome|Tramadol Once A Day 300 mg|
992266|NCT00833794|O3|Outcome|Tramadol Once A Day 200 mg|
992267|NCT00833794|O2|Outcome|2 Placebo|
992268|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992269|NCT00833794|O2|Outcome|2 Placebo|
992270|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992271|NCT00833794|O2|Outcome|2 Placebo|
992272|NCT00833794|O1|Outcome|1 Tramadol Once A Day|
992273|NCT00833794|E2|Reported Event|2 Placebo|
992274|NCT00833794|E1|Reported Event|1 Tramadol Once A Day|
992275|NCT00833781|B3|Baseline|Total|Total of all reporting groups
992276|NCT00833781|B2|Baseline|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
992277|NCT00833781|B1|Baseline|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
992278|NCT00833781|P2|Participant Flow|Autologous Dendritic Cells Without Transfected mRNA.|"Dendritic cell vaccine without transfected mRNA.~Autologous dendritic cells not transfected with mRNA.: Injections will be administered intradermally at weeks 0, 2, 6 and 10."
992279|NCT00833781|P1|Participant Flow|mRNA-transfected Autologous Dendritic Cell Vaccine.|mRNA-transfected autologous dendritic cells: Injections will be administered intradermally at weeks 0, 2, 6 and 10.
992280|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992281|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992282|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992283|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992284|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992285|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992286|NCT00833781|O2|Outcome|Dendritic Cell Vaccine Without Transfected mRNA.|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992287|NCT00833781|O1|Outcome|mRNA-transfected Autologous Dendritic Cells|Injections were administered intradermally at weeks 0, 2, 6 and 10.
992288|NCT00833781|E1|Reported Event|mRNA Transfected DCs|
992289|NCT00833755|B5|Baseline|Total|Total of all reporting groups
992290|NCT00833755|B4|Baseline|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
992291|NCT00833755|B3|Baseline|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
992292|NCT00833755|B2|Baseline|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
992293|NCT00833755|B1|Baseline|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
992294|NCT00833755|P4|Participant Flow|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
992295|NCT00833755|P3|Participant Flow|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
992296|NCT00833755|P2|Participant Flow|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
992297|NCT00833755|P1|Participant Flow|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
992298|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
992299|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
992300|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
992301|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
992302|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
992303|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
992304|NCT00833755|O2|Outcome|Opioid - Placebo|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
992305|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
992306|NCT00833755|O4|Outcome|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
992307|NCT00833755|O3|Outcome|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
992308|NCT00833755|O2|Outcome|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
992309|NCT00833755|O1|Outcome|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a ketamine treatment during the study.
992310|NCT00833755|E4|Reported Event|Non-opioid - Placebos|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a placebo treatment.
992311|NCT00833755|E3|Reported Event|Non-opioid - Ketamine|This group will include subjects who have chronic pain conditions but not on an opioid regimen over the last 3 months. Subjects in this group will be randomized to receive a ketamine treatment.
992312|NCT00833755|E2|Reported Event|Opioid - Placebos|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
992313|NCT00833755|E1|Reported Event|Opioid - Ketamine|Subjects who have chronic pain conditions treated with an opioid regimen will be randomized to receive a placebo treatment during the study.
992314|NCT00833703|B3|Baseline|Total|Total of all reporting groups
992315|NCT00833703|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
992316|NCT00833703|B1|Baseline|Placebo|0.2 mL/kg/day matching placebo solution once daily
992388|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992318|NCT00833703|P1|Participant Flow|Placebo|0.2 mL/kg/day matching placebo solution once daily
992319|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
992320|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
992321|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
992322|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
992323|NCT00833703|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
992324|NCT00833703|O1|Outcome|Placebo|0.2 mL/kg/day matching placebo solution once daily
992325|NCT00833703|E2|Reported Event|Clopidogrel 0.2 mg/kg/Day|0.2 mL/kg/day Clopidogrel reconstituted solution at 1mg/mL once daily
992326|NCT00833703|E1|Reported Event|Placebo|0.2 mL/kg/day matching placebo solution once daily
992327|NCT00833690|B4|Baseline|Total|Total of all reporting groups
992328|NCT00833690|B3|Baseline|[C.]Moderate|Inosine to produce a moderate urate elevation
992329|NCT00833690|B2|Baseline|[B:]Mild|Inosine to produce a mild urate elevation
992330|NCT00833690|B1|Baseline|[A:]Placebo|Placebo to produce no urate elevation
992331|NCT00833690|P3|Participant Flow|[C.]Moderate|Inosine to produce a moderate urate elevation
992332|NCT00833690|P2|Participant Flow|[B:]Mild|Inosine to produce a mild urate elevation
992333|NCT00833690|P1|Participant Flow|[A:]Placebo|Placebo to produce no urate elevation
992334|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992335|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992336|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992337|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992338|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992339|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992340|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992341|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992342|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992343|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992344|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992345|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992346|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992347|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992348|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992349|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992350|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992351|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992352|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992353|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992354|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992355|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992356|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992357|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992358|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992359|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992360|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992361|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992362|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992363|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992364|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992365|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992366|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992367|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992368|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992369|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992370|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992371|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992372|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992373|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992374|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992375|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992376|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992377|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992378|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992379|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992380|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992381|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992382|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992383|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992384|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992385|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992386|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992387|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992391|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992392|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992393|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992394|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992395|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992396|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992397|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992398|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992399|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992400|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992401|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992402|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992403|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992404|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992405|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992406|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992407|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992408|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992409|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992410|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992411|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992412|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992413|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992414|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992415|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992416|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992417|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992418|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992419|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992420|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992421|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992422|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992423|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992424|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992425|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992426|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992427|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992428|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992429|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992430|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992431|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992432|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992433|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992434|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992435|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992436|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992437|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992438|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992439|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992440|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992441|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992442|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992443|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992444|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992445|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992446|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992447|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992448|NCT00833690|O3|Outcome|[C.]Moderate|Inosine to produce a moderate urate elevation
992449|NCT00833690|O2|Outcome|[B:]Mild|Inosine to produce a mild urate elevation
992450|NCT00833690|O1|Outcome|[A:]Placebo|Placebo to produce no urate elevation
992451|NCT00833690|E3|Reported Event|[C.]Moderate|Inosine to produce a moderate urate elevation
992452|NCT00833690|E2|Reported Event|[B:]Mild|Inosine to produce a mild urate elevation
992453|NCT00833690|E1|Reported Event|[A:]Placebo|Placebo to produce no urate elevation
992454|NCT00834756|B3|Baseline|Total|Total of all reporting groups
992455|NCT00834756|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
992456|NCT00834756|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
992457|NCT00834756|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
992458|NCT00834756|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
992459|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
992460|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
992461|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
992462|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
992463|NCT00834756|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
992464|NCT00834756|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
992465|NCT00834743|B3|Baseline|Total|Total of all reporting groups
992466|NCT00834743|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
992467|NCT00834743|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
992468|NCT00834743|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
992469|NCT00834743|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
992470|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
992471|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
992472|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
992473|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
992474|NCT00834743|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
992475|NCT00834743|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
992476|NCT00834717|B3|Baseline|Total|Total of all reporting groups
992477|NCT00834717|B2|Baseline|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
992478|NCT00834717|B1|Baseline|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
992479|NCT00834717|P2|Participant Flow|Kytril® (Reference) First|Kytril 1 mg Tablet (reference) dosed in first period followed by Granisetron 1 mg Tablet (test) dosed in second period
992480|NCT00834717|P1|Participant Flow|Granisetron (Test) First|Granisetron 1 mg Tablet (test) dosed in first period followed by Kytril® 1 mg Tablet (reference) dosed in second period
992481|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
992482|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
992483|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
992484|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
992485|NCT00834717|O2|Outcome|Kytril®|Kytril 1 mg Tablet (reference) dosed in either period
992486|NCT00834717|O1|Outcome|Granisetron|Granisetron 1 mg Tablet (test) dosed in either period
992487|NCT00834678|B1|Baseline|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992488|NCT00834678|P1|Participant Flow|Bendamustine and Erlotinib|Patients in dose level I were administered Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and 100 mg PO of Erlotinib on days 5 – 21 of each 28 day cycle.
992489|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992490|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992491|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992492|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992493|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992494|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992495|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.~Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
992535|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
992536|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
992537|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
992496|NCT00834678|O1|Outcome|Bendamustine and Erlotinib|"Participants in dose level I were administered 100 mg/m^2 IV of Bendamustine on days 1 and 2 and 100 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle.~Participants in dose level II were administered 120 mg/m^2 IV of Bendamustine on days 1 and 2 and 150 mg PO of Erlotinib on days 5 - 21 of each 28 day cycle."
992497|NCT00834678|E1|Reported Event|Bendamustine and Erlotinib|"Bendamustine 100 or 120 mg/m2 IV on days 1 and 2 and erlotinib 100 or 150 mg po on days 5 – 21 of each 28 day cycle.~bendamustine: 100 or 120 mg/m2 IV on days 1 and 2~erlotinib: 100 or 150 mg po on days 5 – 21 of each 28 day cycle~Maintenance erlotinib: 150 mg po daily (days 1 - 28 of 28 day cycle)"
992498|NCT00834639|B3|Baseline|Total|Total of all reporting groups
992499|NCT00834639|B2|Baseline|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
992500|NCT00834639|B1|Baseline|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
992501|NCT00834639|P2|Participant Flow|Depakote® First|500 mg Depakote® Delayed Release Tablets reference product dosed in first period followed by 500 mg Divalproex Sodium Delayed Release Tablets test product dosed in the second period.
992502|NCT00834639|P1|Participant Flow|Divalproex Sodium First|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in first period followed by 500 mg Depakote® Delayed Release Tablets reference product dosed in the second period.
992503|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
992504|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
992505|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
992506|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
992507|NCT00834639|O2|Outcome|Depakote®|500 mg Depakote® Delayed Release Tablets reference product dosed in either period.
992508|NCT00834639|O1|Outcome|Divalproex Sodium|500 mg Divalproex Sodium Delayed Release Tablets test product dosed in either period.
992509|NCT00834626|B1|Baseline|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
992510|NCT00834626|P1|Participant Flow|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
992511|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
992512|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
992513|NCT00834626|O1|Outcome|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
992514|NCT00834626|O1|Outcome|Percentage of Participants Not Requiring Insulin|Percentage of participants not requiring Insulin assessed at 1 year post-surgery
992515|NCT00834626|E1|Reported Event|Surgery Group|Interventional study of the effects of a novel metabolic surgery with anatomical modifications, to give remission of Type-2 Diabetes
992516|NCT00834613|B3|Baseline|Total|Total of all reporting groups
992517|NCT00834613|B2|Baseline|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
992518|NCT00834613|B1|Baseline|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
992519|NCT00834613|P2|Participant Flow|Reference (Glucophage®) First|750 mg Glucophage® XR Tablets reference product dosed in first period followed by 750 mg Metformin Extended Release Tablets test product dosed in the second period.
992520|NCT00834613|P1|Participant Flow|Test (Metformin) First|750 mg Metformin Extended Release Tablets test product dosed in first period followed by 750 mg Glucophage® XR Tablets reference product dosed in the second period.
992521|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
992522|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
992523|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
992524|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
992525|NCT00834613|O2|Outcome|Reference (Glucophage®)|750 mg Glucophage® XR Tablets reference product dosed in either period.
992526|NCT00834613|O1|Outcome|Test (Metformin)|750 mg Metformin Extended Release Tablets test product dosed in either period.
992527|NCT00834587|B3|Baseline|Total|Total of all reporting groups
992528|NCT00834587|B2|Baseline|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
992529|NCT00834587|B1|Baseline|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
992530|NCT00834587|P2|Participant Flow|Metaglip™ (Reference) First|Metaglip™ 5/500 mg Tablet (reference) dosed in first period followed by Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in second period
992531|NCT00834587|P1|Participant Flow|Glipizide Metformin (Test) First|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in first period followed by Metaglip™ 5/500 mg Tablet (reference) dosed in second period
992532|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
992533|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
992534|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
992585|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
992538|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
992539|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
992540|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
992541|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
992542|NCT00834587|O2|Outcome|Metaglip™|Metaglip™ 5/500 mg Tablet (reference) dosed in either period
992543|NCT00834587|O1|Outcome|Glipizide Metformin|Glipizide Metformin Hydrochloride 5/500 mg Tablet (test) dosed in either period
992544|NCT00834574|B3|Baseline|Total|Total of all reporting groups
992545|NCT00834574|B2|Baseline|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
992546|NCT00834574|B1|Baseline|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
992547|NCT00834574|P2|Participant Flow|Omnicef® (Reference) First|250mg/5mL Omnicef® for Oral Suspension reference product dosed in first period followed by 250mg/5mL Cefdinir for Oral Suspendion test product dosed in the second period.
992548|NCT00834574|P1|Participant Flow|Cefdinir (Test) First|250mg/5mL Cefdinir for Oral Suspension test product dosed in first period followed by 250mg/5mL Omnicef® for Oral Suspension reference product dosed in the second period.
992549|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
992550|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
992551|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
992552|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
992553|NCT00834574|O2|Outcome|Omnicef® (Reference)|250mg/5mL Omnicef® for Oral Suspension reference product dosed in either period.
992554|NCT00834574|O1|Outcome|Cefdinir (Test)|250mg/5mL Cefdinir for Oral Suspension test product dosed in either period.
992555|NCT00834561|B3|Baseline|Total|Total of all reporting groups
992556|NCT00834561|B2|Baseline|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
992557|NCT00834561|B1|Baseline|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
992558|NCT00834561|P2|Participant Flow|Lamictal® (Reference) First|Lamictal® 200 mg Tablet (reference) dosed in first period followed by Lamotrigine 200 mg Tablet (test) dosed in second period
992559|NCT00834561|P1|Participant Flow|Lamotrigine (Test) First|Lamotrigine 200 mg Tablet (test) dosed in first period followed by Lamictal® 200 mg Tablet (reference) dosed in second period
992560|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
992561|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
992562|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
992563|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
992564|NCT00834561|O2|Outcome|Lamictal®|Lamictal® 200 mg Tablet (reference) dosed in either period
992565|NCT00834561|O1|Outcome|Lamotrigine|Lamotrigine 200 mg Tablet (test) dosed in either period
992566|NCT00834535|B3|Baseline|Total|Total of all reporting groups
992567|NCT00834535|B2|Baseline|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
992568|NCT00834535|B1|Baseline|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
992569|NCT00834535|P2|Participant Flow|Omnicef® (Reference) First|300 mg Omnicef® Capsules reference product dosed in first period followed by 300 mg Cefdinir Capsules test product dosed in the second period.
992570|NCT00834535|P1|Participant Flow|Cefdinir (Test) First|300 mg Cefdinir Capsules test product dosed in first period followed by 300 mg Omnicef® Capsules reference product dosed in the second period.
992571|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
992572|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
992573|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
992574|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
992575|NCT00834535|O2|Outcome|Omnicef® (Reference)|300 mg Omnicef® Capsules reference product dosed in either period.
992576|NCT00834535|O1|Outcome|Cefdinir (Test)|300 mg Cefdinir Capsules test product dosed in either period.
992577|NCT00834522|B3|Baseline|Total|Total of all reporting groups
992578|NCT00834522|B2|Baseline|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
992579|NCT00834522|B1|Baseline|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
992580|NCT00834522|P2|Participant Flow|Kytril® (Reference) First|Kytril® 2 x 1 mg Tablet (reference) dosed in first period followed by Granisetron 2 x 1 mg Tablet (test) dosed in second period
992581|NCT00834522|P1|Participant Flow|Granisetron (Test) First|Granisetron 2 x 1 mg Tablet (test) dosed in first period followed by Kytril® 2 x 1 mg Tablet (reference) dosed in second period
992582|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
992583|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
992584|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
992586|NCT00834522|O2|Outcome|Kytril®|Kytril® 2 x 1 mg Tablet (reference) dosed in either period
1033053|NCT00734630|B3|Baseline|Total|Total of all reporting groups
992587|NCT00834522|O1|Outcome|Granisetron|Granisetron 2 x 1 mg Tablet (test) dosed in either period
992588|NCT00834483|B3|Baseline|Total|Total of all reporting groups
992589|NCT00834483|B2|Baseline|Control Group|Layered traditional wound closure (monocryl)
992590|NCT00834483|B1|Baseline|Treatment Group|Knotless suture for wound closure
992591|NCT00834483|P2|Participant Flow|Control Group|Layered traditional wound closure (monocryl)
992592|NCT00834483|P1|Participant Flow|Treatment Group|Knotless suture for wound closure
992593|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
992594|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
992595|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
992596|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
992597|NCT00834483|O2|Outcome|Control Group|Layered traditional wound closure (monocryl)
992598|NCT00834483|O1|Outcome|Treatment Group|Knotless suture for wound closure
992599|NCT00834483|E2|Reported Event|Control Group|Layered traditional wound closure (monocryl)
992600|NCT00834483|E1|Reported Event|Treatment Group|Knotless suture for wound closure
992601|NCT00834444|B3|Baseline|Total|Total of all reporting groups
992602|NCT00834444|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
992603|NCT00834444|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
992604|NCT00834444|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
992605|NCT00834444|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
992606|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
992607|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
992608|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
992609|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
992610|NCT00834444|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
992611|NCT00834444|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
992612|NCT00834431|B3|Baseline|Total|Total of all reporting groups
992613|NCT00834431|B2|Baseline|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
992614|NCT00834431|B1|Baseline|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
992615|NCT00834431|P2|Participant Flow|Famvir® First|500 mg Famvir® Tablets reference product dosed in first period followed by 500 mg Famciclovir Tablets test product dosed in the second period.
992616|NCT00834431|P1|Participant Flow|Famciclovir First|500 mg Famciclovir Tablets test product dosed in first period followed by 500 mg Famvir® Tablets reference product dosed in the second period.
992617|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
992618|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
992619|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
992620|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
992621|NCT00834431|O2|Outcome|Famvir®|500 mg Famvir® Tablets reference product dosed in either period.
992622|NCT00834431|O1|Outcome|Famciclovir|500 mg Famciclovir Tablets test product dosed in either period.
992623|NCT00834418|B3|Baseline|Total|Total of all reporting groups
992624|NCT00834418|B2|Baseline|Arava™|Arava™ 20 mg Tablet
992625|NCT00834418|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
992626|NCT00834418|P2|Participant Flow|Arava™|Arava™ 20 mg Tablet
992627|NCT00834418|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
992628|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
992629|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
992630|NCT00834418|O2|Outcome|Arava™|Arava™ 20 mg Tablet
992631|NCT00834418|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
992632|NCT00834405|B3|Baseline|Total|Total of all reporting groups
992633|NCT00834405|B2|Baseline|Arava®|Arava® 20 mg Tablet
992634|NCT00834405|B1|Baseline|Leflunomide|Leflunomide 20 mg Tablet
992635|NCT00834405|P2|Participant Flow|Arava®|Arava® 20 mg Tablet
992636|NCT00834405|P1|Participant Flow|Leflunomide|Leflunomide 20 mg Tablet
992637|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
992638|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
992639|NCT00834405|O2|Outcome|Arava®|Arava® 20 mg Tablet
992640|NCT00834405|O1|Outcome|Leflunomide|Leflunomide 20 mg Tablet
992641|NCT00834366|B3|Baseline|Total|Total of all reporting groups
992642|NCT00834366|B2|Baseline|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992643|NCT00834366|B1|Baseline|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
992644|NCT00834366|P2|Participant Flow|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992645|NCT00834366|P1|Participant Flow|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
996998|NCT00823043|E1|Reported Event|Total Subjects Surveyed|
993266|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
992646|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992647|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
992648|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992649|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
992650|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992651|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
992652|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992653|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
992654|NCT00834366|O2|Outcome|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992655|NCT00834366|O1|Outcome|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
992656|NCT00834366|E2|Reported Event|Tramadol HCl 200 mg Uncoated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Uncoated Tablet based on randomization schedule.
992657|NCT00834366|E1|Reported Event|Tramadol HCl 200 mg Film-coated Tablets|Single oral administration in fasting conditions of 1x200mg Tramadol HCl 200 mg Film-coated Tablet based on randomization schedule.
992658|NCT00834340|B3|Baseline|Total|Total of all reporting groups
992659|NCT00834340|B2|Baseline|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
992660|NCT00834340|B1|Baseline|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
992661|NCT00834340|P2|Participant Flow|Amaryl® (Reference) First|Amaryl® 4 mg Tablet (reference) dosed in first period followed by Glimepiride 4 mg Tablet (test) dosed in second period
992662|NCT00834340|P1|Participant Flow|Glimepiride (Test) First|Glimepiride 4 mg Tablet (test) dosed in first period followed by Amaryl® 4 mg Tablet (reference) dosed in second period
992663|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
992664|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
992665|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
992666|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
992667|NCT00834340|O2|Outcome|Amaryl®|Amaryl® 4 mg Tablet (reference) dosed in either period
992668|NCT00834340|O1|Outcome|Glimepiride|Glimepiride 4 mg Tablet (test) dosed in either period
992669|NCT00834288|B3|Baseline|Total|Total of all reporting groups
992670|NCT00834288|B2|Baseline|Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First|1 x 50 mg Tramadol HCl IR (Ultram®) Tablet 6-Hourly reference product dosed in first period followed by Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II). IR = Immediate Release.
992671|NCT00834288|B1|Baseline|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
992672|NCT00834288|P2|Participant Flow|Reference (Trazodone IR (Desyrel®) 100 mg 8-hourly) First|"1 x 100 mg Trazodone HCl IR (Desyrel®) Tablet 8-Hourly reference product dosed in first period followed by Trazodone OAD (Once-A-Day) Tablet Daily test product dosed in the second period. The two periods were separated by a washout of at least 7 calendar days.~IR = Immediate Release."
992673|NCT00834288|P1|Participant Flow|Test (Tramadol HCl OAD 200 mg) First|1 x 200 mg Tramadol OAD (Once-A-Day) Tablet Daily test product dosed in first period followed by Tramadol IR (Ultram®) 50 mg 6-hourly) reference product dosed in the second period. The two treatment phases each started with a run-in period of 4 days (Days 1 to 4), a profile period and clinic stay of 3 days (Days 5 to 7) (clinic days and observation period) and a drug-free period of 16 days between treatment phases (Day 7 of Treatment phase I until Day 1 of the run-in period of Treatment phase II).
992674|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992675|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992676|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992756|NCT00834171|B2|Baseline|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
992677|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992678|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992679|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992680|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992681|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992682|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992683|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992684|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992685|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992686|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992687|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992688|NCT00834288|O2|Outcome|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992689|NCT00834288|O1|Outcome|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992690|NCT00834288|E2|Reported Event|Tramadol IR (Ultram®) 50 mg 6-hourly|"Tramadol IR (Ultram®) 50 mg 6-hourly Group includes the treatment period 1 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence and the treatment period 2 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence."
992691|NCT00834288|E1|Reported Event|Tramadol HCl OAD 200 mg|"Tramadol HCl OAD 200 mg Group includes the treatment period 1 data from subjects in the Test (Tramadol HCl OAD 200 mg) First treatment sequence and the treatment period 2 data from subjects in the Reference (Tramadol IR (Ultram®) 50 mg 6-hourly) First treatment sequence."
992692|NCT00834275|B3|Baseline|Total|Total of all reporting groups
992693|NCT00834275|B2|Baseline|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
992694|NCT00834275|B1|Baseline|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
992695|NCT00834275|P2|Participant Flow|Duricef® (Reference) First|500 mg Duricef® Capsules reference product dosed in first period followed by 500 mg Cefadroxil Capsules test product dosed in the second period.
992696|NCT00834275|P1|Participant Flow|Cefadroxil (Test) First|500 mg Cefadroxil Capsules test product dosed in first period followed by 500 mg Duricef® Capsules reference product dosed in the second period.
992697|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
992698|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
992699|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
992700|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
992701|NCT00834275|O2|Outcome|Duricef® (Reference)|500 mg Duricef® Capsules reference product dosed in either period.
992702|NCT00834275|O1|Outcome|Cefadroxil (Test)|500 mg Cefadroxil Capsules test product dosed in either period.
992703|NCT00834249|B3|Baseline|Total|Total of all reporting groups
992704|NCT00834249|B2|Baseline|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
992705|NCT00834249|B1|Baseline|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
992706|NCT00834249|P2|Participant Flow|Effexor® (Reference) First|Effexor® 25 mg Tablet (reference) dosed in first period followed by Venlafaxine 25 mg Tablet (test) dosed in second period
992707|NCT00834249|P1|Participant Flow|Venlafaxine (Test) First|Venlafaxine 25 mg Tablet (test) dosed in first period followed by Effexor® 25 mg Tablet (reference) dosed in second period
992708|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992709|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992710|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992711|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992712|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992713|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992714|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992715|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992716|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992717|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992718|NCT00834249|O2|Outcome|Effexor®|Effexor® 25 mg Tablet (reference) dosed in either period
992719|NCT00834249|O1|Outcome|Venlafaxine|Venlafaxine 25 mg Tablet (test) dosed in either period
992720|NCT00834236|B3|Baseline|Total|Total of all reporting groups
992721|NCT00834236|B2|Baseline|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992722|NCT00834236|B1|Baseline|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992723|NCT00834236|P2|Participant Flow|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992724|NCT00834236|P1|Participant Flow|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992725|NCT00834236|O2|Outcome|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992726|NCT00834236|O1|Outcome|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992727|NCT00834236|E2|Reported Event|Normal Subject|"healthy subject~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992728|NCT00834236|E1|Reported Event|Gastric Cancer|"gastric cancer patients~normal subject: biomarker in gastric juice, i.e., alpha 1-antitrypsin, CEA~gastric cancer: biomarker in gastric juice, e.g., alpha 1-antitrypsin"
992729|NCT00834210|B3|Baseline|Total|Total of all reporting groups
992730|NCT00834210|B2|Baseline|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
992731|NCT00834210|B1|Baseline|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
992732|NCT00834210|P2|Participant Flow|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
992733|NCT00834210|P1|Participant Flow|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
992734|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
992735|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
992736|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
992737|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
992738|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
992739|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
992740|NCT00834210|O2|Outcome|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
992741|NCT00834210|O1|Outcome|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
992742|NCT00834210|E2|Reported Event|Tazarotene Cream 0.1%|Tazarotene Cream 0.1%
992743|NCT00834210|E1|Reported Event|Dapsone Gel 5% and Tazarotene Cream 0.1%|Dapsone Gel 5% and Tazarotene Cream 0.1%
992744|NCT00834197|B3|Baseline|Total|Total of all reporting groups
992745|NCT00834197|B2|Baseline|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
992746|NCT00834197|B1|Baseline|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
992747|NCT00834197|P2|Participant Flow|Reference (Remeron®) First|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in first period followed by 15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in the second period.
992748|NCT00834197|P1|Participant Flow|Test (Mirtazapine) First|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in first period followed by 15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in the second period.
992749|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
992750|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
992751|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
992752|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
992753|NCT00834197|O2|Outcome|Reference (Remeron®)|15 mg Remeron® SolTab™ Orally Disintegrating Tablets reference product dosed in either period.
992754|NCT00834197|O1|Outcome|Test (Mirtazapine)|15 mg Mirtazapine Orally Disintegrating Tablets test product dosed in either period.
992755|NCT00834171|B3|Baseline|Total|Total of all reporting groups
992757|NCT00834171|B1|Baseline|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
992758|NCT00834171|P2|Participant Flow|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
992759|NCT00834171|P1|Participant Flow|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
992760|NCT00834171|O2|Outcome|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
992761|NCT00834171|O1|Outcome|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
992762|NCT00834171|E2|Reported Event|Loteprednol Etabonate (0.5%) and Tobramycin (0.3%)|Loteprednol etabonate (0.5%) and tobramycin (0.3%)
992763|NCT00834171|E1|Reported Event|Loteprednol Etabonate Ophthalmic Suspension 0.5%|Loteprednol etabonate ophthalmic suspension 0.5%
992764|NCT00834132|B3|Baseline|Total|Total of all reporting groups
992765|NCT00834132|B2|Baseline|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
992766|NCT00834132|B1|Baseline|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
992767|NCT00834132|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® 600 mg tablet (reference) dosed in first period followed by Azithromycin 600 mg tablet (test) dosed in second period
992768|NCT00834132|P1|Participant Flow|Azithromycin (Test) First|Azithromycin 600 mg tablet (test) dosed in first period followed by Zithromax® 600 mg tablet (reference) dosed in second period
992769|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
992770|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
992771|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
992772|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
992773|NCT00834132|O2|Outcome|Zithromax®|Zithromax® 600 mg tablet (reference) dosed in either period
992774|NCT00834132|O1|Outcome|Azithromycin|Azithromycin 600 mg tablet (test) dosed in either period
992775|NCT00834080|B1|Baseline|VIVITROL, 380mg|
992776|NCT00834080|P1|Participant Flow|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
992777|NCT00834080|O1|Outcome|VIVITROL|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
992778|NCT00834080|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Study drug was administered by intramuscular (IM) injection once monthly for 24 months.
992779|NCT00834067|B3|Baseline|Total|Total of all reporting groups
992780|NCT00834067|B2|Baseline|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
992781|NCT00834067|B1|Baseline|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
992782|NCT00834067|P2|Participant Flow|Reference (Uniretic®) First|15/25 mg Uniretic® Tablets reference product dosed in first period followed by 15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in the second period.
992783|NCT00834067|P1|Participant Flow|Test (Moexipril HCl/HCTZ) First|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in first period followed by 15/25 mg Uniretic® Tablets reference product dosed in the second period.
992784|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992785|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992786|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992787|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992788|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992789|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992790|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992791|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992792|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992793|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992794|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992795|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992796|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992797|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992798|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992799|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992800|NCT00834067|O2|Outcome|Reference (Uniretic®)|15/25 mg Uniretic® Tablets reference product dosed in either period.
992801|NCT00834067|O1|Outcome|Test (Moexipril HCl/HCTZ)|15/25 mg Moexipril HCl/Hydrochlorothiazide Tablets test product dosed in either period.
992802|NCT00834041|B3|Baseline|Total|Total of all reporting groups
992803|NCT00834041|B2|Baseline|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992804|NCT00834041|B1|Baseline|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
993017|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
992805|NCT00834041|P2|Participant Flow|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992806|NCT00834041|P1|Participant Flow|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
992807|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992808|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
992809|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992810|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
992811|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992812|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
992813|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992814|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
992815|NCT00834041|O2|Outcome|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992816|NCT00834041|O1|Outcome|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
992817|NCT00834041|E2|Reported Event|Aliskiren 6 mg/kg|Patients received aliskiren 6 mg/kg of their body weight orally once daily at approximately 8 AM.
992818|NCT00834041|E1|Reported Event|Aliskiren 2 mg/kg|Patients received aliskiren 2 mg/kg of their body weight orally once daily at approximately 8 AM.
992819|NCT00833976|B1|Baseline|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
992820|NCT00833976|P1|Participant Flow|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
992821|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
992822|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
992823|NCT00833976|O1|Outcome|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
992824|NCT00833976|E1|Reported Event|Open-label Lovaza (Omega-3 Fatty Acids)|"4g per day (4g once a day or 2g two times a day) for 16 weeks~Lovaza: 4 grams per day"
992825|NCT00833937|B3|Baseline|Total|Total of all reporting groups
992826|NCT00833937|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
992827|NCT00833937|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
992828|NCT00833937|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
992829|NCT00833937|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
992830|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
992831|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
992832|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
992833|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
992834|NCT00833937|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
992835|NCT00833937|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
992836|NCT00833924|B1|Baseline|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
992837|NCT00833924|P1|Participant Flow|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
992838|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
992839|NCT00833924|O1|Outcome|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
992840|NCT00833924|E1|Reported Event|Zenith® Low Profile AAA Endovascular Graft|The Zenith® Low Profile AAA Endovascular Graft and ancillary components are indicated for the endovascular treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair.
992841|NCT00833911|B1|Baseline|300 mg Tramadol HCl OAD|
992842|NCT00833911|P1|Participant Flow|300 mg Tramadol HCl OAD|
992843|NCT00833911|O3|Outcome|12-months Safety|
992844|NCT00833911|O2|Outcome|6-months Safety|
992845|NCT00833911|O1|Outcome|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
992846|NCT00833911|E3|Reported Event|12-months Safety|
992847|NCT00833911|E2|Reported Event|6-months Safety|
992848|NCT00833911|E1|Reported Event|All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum|All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
992849|NCT00833898|B3|Baseline|Total|Total of all reporting groups
992850|NCT00833898|B2|Baseline|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992851|NCT00833898|B1|Baseline|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992852|NCT00833898|P2|Participant Flow|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992853|NCT00833898|P1|Participant Flow|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992854|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992855|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992856|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992857|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992858|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992859|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992860|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992861|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992862|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992863|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992864|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992865|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992866|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992867|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992868|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992869|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992870|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992871|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992872|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992873|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992874|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992875|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992876|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992877|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992905|NCT00833833|B4|Baseline|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992878|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992879|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992880|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992881|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992882|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992883|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992884|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992885|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992886|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992887|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992888|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992889|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992890|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992891|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992892|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992893|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992894|NCT00833898|O2|Outcome|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992895|NCT00833898|O1|Outcome|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992896|NCT00833898|E2|Reported Event|Caregiver Intervention|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; Psychoeducation Paced Respiration and Relaxation (PEPRR), includes one-on-one psychoeducation, stress management intervention, with paced respiration.
992897|NCT00833898|E1|Reported Event|Caregiver Control|Orientation class; laboratory biomarker analysis; questionnaire administration; survey administration; treatment as usual psychosocial care.
992898|NCT00833859|B1|Baseline|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
992899|NCT00833859|P1|Participant Flow|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
992900|NCT00833859|O1|Outcome|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
992901|NCT00833859|E1|Reported Event|Chemotherapy Followed by Radiation Treatment|Gemcitabine, Taxotere, Xeloda (GTX)-Stereotactic Radiosurgery (SRS). GTX: 21 day cycle x 2 Gemcitabine 750mg/m2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m2 on days 1-14. Stereotactic body radiation therapy (SBRT) 25.
992902|NCT00833833|B7|Baseline|Total|Total of all reporting groups
992903|NCT00833833|B6|Baseline|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
992904|NCT00833833|B5|Baseline|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992967|NCT00833638|P2|Participant Flow|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992906|NCT00833833|B3|Baseline|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992907|NCT00833833|B2|Baseline|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992908|NCT00833833|B1|Baseline|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992909|NCT00833833|P6|Participant Flow|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
992910|NCT00833833|P5|Participant Flow|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992911|NCT00833833|P4|Participant Flow|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992912|NCT00833833|P3|Participant Flow|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992913|NCT00833833|P2|Participant Flow|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992914|NCT00833833|P1|Participant Flow|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992915|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
992916|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992917|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
992918|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992919|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
992920|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992921|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
992922|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992923|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide or to discontinue treatment.
992924|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992925|NCT00833833|O4|Outcome|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
992926|NCT00833833|O3|Outcome|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
992927|NCT00833833|O2|Outcome|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
992928|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992929|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992930|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
993016|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
992931|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992932|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992933|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992934|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992935|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992936|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992937|NCT00833833|O2|Outcome|Phase 2: Pomalidomide|4 mg pomalidomide was given once per day on Days 1-21 of each 28-day cycle until PD. Participants in the single agent pomalidomide treatment arm who developed confirmed PD at any time had the option to receive oral dexamethasone at the starting dose in addition to their current dose of pomalidomide, or to discontinue treatment.
992938|NCT00833833|O1|Outcome|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992939|NCT00833833|O4|Outcome|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992940|NCT00833833|O3|Outcome|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992941|NCT00833833|O2|Outcome|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992942|NCT00833833|O1|Outcome|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992943|NCT00833833|E8|Reported Event|Phase 2: Pomalidomide (Overall)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the entire study up to the data cut-off, thus including both the time participants were only on pomalidomide and the time after PD when participants were on pomalidomide and dexamethasone."
992944|NCT00833833|E7|Reported Event|Phase 2: Pomalidomide (Pom + Dex Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time after PD when participants were on both pomalidomide and dexamethasone."
992945|NCT00833833|E6|Reported Event|Phase 2: Pomalidomide (Pom Only)|"Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing therapy or adding dexamethasone.~Data are reported during the time when participants were on pomalidomide alone, before dexamethasone was added."
992946|NCT00833833|E5|Reported Event|Phase 2: Pomalidomide + Dexamethasone|Combination therapy of 4 mg pomalidomide given once per day on Days 1-21 of each 28-day cycle and the starting dose of dexamethasone (either 40mg or 20 mg) on days 1, 8, 15, and 22 of each 28-day cycle.
992947|NCT00833833|E4|Reported Event|Phase 1: 5 mg Pomalidomide|Pomalidomide 5 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992948|NCT00833833|E3|Reported Event|Phase 1: 4 mg Pomalidomide|Pomalidomide 4 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992949|NCT00833833|E2|Reported Event|Phase 1: 3 mg Pomalidomide|Pomalidomide 3 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992950|NCT00833833|E1|Reported Event|Phase 1: 2 mg Pomalidomide|Pomalidomide 2 mg daily on days 1-21 of each 28-day cycle. Upon PD, participants had the option of discontinuing treatment or adding dexamethasone.
992951|NCT00833664|B3|Baseline|Total|Total of all reporting groups
992952|NCT00833664|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
992953|NCT00833664|B1|Baseline|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
992954|NCT00833664|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
992955|NCT00833664|P1|Participant Flow|Terbinafine (Test) First|Terbinafine 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
992956|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
992957|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
992958|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
992959|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
992960|NCT00833664|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
992961|NCT00833664|O1|Outcome|Terbinafine|Terbinafine 250 mg Tablet (test) dosed in either period
992962|NCT00833638|B4|Baseline|Total|Total of all reporting groups
992963|NCT00833638|B3|Baseline|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992964|NCT00833638|B2|Baseline|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992965|NCT00833638|B1|Baseline|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992966|NCT00833638|P3|Participant Flow|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
996999|NCT00822900|B3|Baseline|Total|Total of all reporting groups
992968|NCT00833638|P1|Participant Flow|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992969|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992970|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992971|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992972|NCT00833638|O1|Outcome|Tadalafil 5 mg Double-blind|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992973|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992974|NCT00833638|O1|Outcome|Tadalafil 2.5 mg Double-blind|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992975|NCT00833638|O2|Outcome|Tadalafil 5 mg Open-label|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992976|NCT00833638|O1|Outcome|Placebo Double-blind|No drug during baseline period, placeob for 14 days, then will continue at 5 mg for 14 days.
992977|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992978|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992979|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992980|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992981|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992982|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992983|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992984|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992985|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992986|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992987|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992988|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992989|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992990|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992991|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992992|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992993|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992994|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992995|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992996|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
992997|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
992998|NCT00833638|O3|Outcome|Placebo|No drug during baseline period, placebo for 14 days, then will continue tadalafil at 5 mg for 14 days.
992999|NCT00833638|O2|Outcome|Tadalafil 5 mg|No drug during baseline period, 5 mg for 14 days, then will continue at 5 mg for 14 days.
993000|NCT00833638|O1|Outcome|Tadalafil 2.5 mg|No drug during baseline period, 2.5 mg for 14 days, then will continue at 5 mg for 14 days.
993001|NCT00833638|E6|Reported Event|Placebo to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving placebo in the double-blind period.
993002|NCT00833638|E5|Reported Event|Tadalafil 5 mg to Tadalafil 5 mg|Participants receiving open-label tadalafil 5 mg after receiving tadalafil 5 mg in the double-blind period.
993003|NCT00833638|E4|Reported Event|Tadalafil 2.5 mg to Tadalafil 5 mg|Participants receiving tadalafil 5 mg in the open-label period after receiving tadalafil 2.5 mg in the double-blind period.
993004|NCT00833638|E3|Reported Event|Placebo|No drug during baseline period followed by placebo for 14 days.
993005|NCT00833638|E2|Reported Event|Tadalafil 5 mg|No drug during baseline period followed by tadalafil 5 mg for 14 days.
993006|NCT00833638|E1|Reported Event|Tadalafil 2.5 mg|No drug during baseline period followed by tadalafil 2.5 mg for 14 days.
993007|NCT00833586|B3|Baseline|Total|Total of all reporting groups
993008|NCT00833586|B2|Baseline|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
993009|NCT00833586|B1|Baseline|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
993010|NCT00833586|P2|Participant Flow|Lamisil® (Reference) First|Lamisil® 250 mg Tablet (reference) dosed in first period followed by Terbinafine 250 mg Tablet (test) dosed in second period
993011|NCT00833586|P1|Participant Flow|Terbinafine (Test) First|Terbinafine HCl 250 mg Tablet (test) dosed in first period followed by Lamisil® 250 mg Tablet (reference) dosed in second period
993012|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
993013|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
993014|NCT00833586|O2|Outcome|Lamisil®|Lamisil® 250 mg Tablet (reference) dosed in either period
993015|NCT00833586|O1|Outcome|Terbinafine|Terbinafine HCl 250 mg Tablet (test) dosed in either period
993018|NCT00833560|B1|Baseline|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
993019|NCT00833560|P1|Participant Flow|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
993020|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
993021|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
993022|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
993023|NCT00833560|O1|Outcome|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
993024|NCT00833560|E1|Reported Event|Cyclophosphamide + Bortezomib + Dexamethasone|Cyclophosphamide + Bortezomib + Dexamethasone for three 21-day cycles
993025|NCT00833547|B3|Baseline|Total|Total of all reporting groups
993026|NCT00833547|B2|Baseline|Placebo|placebo capsule that looks identical to eszopiclone at bedtime on 2 consecutive nights
993027|NCT00833547|B1|Baseline|Eszopiclone|3mg of eszopiclone at bedtime on 2 consecutive nights
993028|NCT00833547|P2|Participant Flow|Eszopiclone|3mg of eszopiclone at bedtime for two consecutive nights
993029|NCT00833547|P1|Participant Flow|Placebo|placebo capsules that appear identical to eszopiclone capsules on 2 consecutive nights
993030|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
993031|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
993032|NCT00833547|O2|Outcome|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
993033|NCT00833547|O1|Outcome|Eszopiclone|3mg of eszopiclone on two consecutive nights
993034|NCT00833547|E2|Reported Event|Placebo|placebo capsule that looks identical to eszopiclone capsule on two consecutive nights
993035|NCT00833547|E1|Reported Event|Eszopiclone|3mg of eszopiclone on two consecutive nights
993036|NCT00833521|B3|Baseline|Total|Total of all reporting groups
993037|NCT00833521|B2|Baseline|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
993038|NCT00833521|B1|Baseline|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
993039|NCT00833521|P2|Participant Flow|Ambien® (Reference) First|Ambien® 10 mg Tablet (reference) dosed in first period followed by Zolpidem Tartrate 10 mg Tablet (test) dosed in second period
993040|NCT00833521|P1|Participant Flow|Zolpidem (Test) First|Zolpidem Tartrate 10 mg Tablet (test) dosed in first period followed by Ambien® 10 mg Tablet (reference) dosed in second period
993041|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
993042|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
993043|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
993044|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
993045|NCT00833521|O2|Outcome|Ambien®|Ambien® 10 mg Tablet (reference) dosed in either period
993046|NCT00833521|O1|Outcome|Zolpidem|Zolpidem Tartrate 10 mg Tablet (test) dosed in either period
993047|NCT00833482|B3|Baseline|Total|Total of all reporting groups
993048|NCT00833482|B2|Baseline|Poor Metabolizers (PM)|Participants without a functional CYP2C19 allele (poor metabolizers, or PM).
993049|NCT00833482|B1|Baseline|Extensive Metabolizers (EM)|Participants with functional CYP2C19 alleles (extensive metabolizers, or EM).
993050|NCT00833482|P6|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993051|NCT00833482|P5|Participant Flow|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
993052|NCT00833482|P4|Participant Flow|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993053|NCT00833482|P3|Participant Flow|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993054|NCT00833482|P2|Participant Flow|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993055|NCT00833482|P1|Participant Flow|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993056|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993057|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
993058|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993059|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
997000|NCT00822900|B2|Baseline|Placebo|
993060|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993061|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993062|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993063|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
993064|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993065|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993066|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993067|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993068|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993069|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
993070|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993071|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993072|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993073|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993074|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993075|NCT00833482|O5|Outcome|Atazanavir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
993076|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993077|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993078|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993079|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993080|NCT00833482|O6|Outcome|Atazanavir/Ritonavir, 300/100 QD (PM)|Treatment B in PM participants: PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993081|NCT00833482|O5|Outcome|Atanazivir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|Treatment E: PM participants received atazanavir/ritonavir, 300/100 mg QD plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
993082|NCT00833482|O4|Outcome|Voriconazole, 50 mg BID (PM)|Treatment D: Participants who were poor metabolizers of CYP2C19 (PM) received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993083|NCT00833482|O3|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993084|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B in EM participants: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993085|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993086|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993087|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993088|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993089|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993090|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mg QD + Voriconazole, 200 mg BID|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993091|NCT00833482|O1|Outcome|Voriconazole, 200 BID|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993092|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993093|NCT00833482|O1|Outcome|Voriconazole, 200 BID (EM)|Treatment A: Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993094|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993095|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993096|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993097|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993098|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993099|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EMs received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993100|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993101|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993102|NCT00833482|O2|Outcome|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|Treatment C: EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993103|NCT00833482|O1|Outcome|Atazanavir/Ritonavir, 300/100 QD (EM)|Treatment B: EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993104|NCT00833482|E6|Reported Event|Atazanazvir/Ritonavir, 300/100 QD + Voriconazole, 50 BID (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 100 mg BID, on Day 21, then 50 mg BID on Days 22-30.
993105|NCT00833482|E5|Reported Event|Voriconazole, 50 mg BID (PM)|Participants who were poor metabolizers of CYP2C19 (PM)received voriconazole, 100 mg BID, on Day 1 then 50 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993106|NCT00833482|E4|Reported Event|Atazanavir/Ritonavir, 300/100mgQD + Voriconazole, 200mgBID(EM)|EM participants received atazanavir/ritonavir, 300/100 mg QD, plus voriconazole, 400 mg BID on Day 21 then 200 mg BID on Days 22-30. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal, and 1 hour before voriconazole morning dose.
993107|NCT00833482|E3|Reported Event|Atazanavir/Ritonavir, 300/100 QD (PM)|PM participants received atazanavir/ritonavir, 300/100 mg QD, on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal.
993108|NCT00833482|E2|Reported Event|Atazanavir/Ritonavir, 300/100 QD (EM)|EM participants received atazanavir/ritonavir, 300/100 mg once daily (QD), on Days 11 through 20. Atazanavir/ritonavir dose was administered in the morning within 5 minutes of completing a light meal
993109|NCT00833482|E1|Reported Event|Voriconazole, 200 BID (EM)|Participants with functional CYP2C19 alleles (EM) received voriconazole, 400 mg, twice daily (BID) on Day 1, then 200 mg BID on Days 2 and 3. Voriconazole dose was given at least 1 hour after a meal.
993110|NCT00833469|B1|Baseline|Escitalopram|"Flexible dose escitalopram 10mg~Escitalopram: Once daily by mouth"
993111|NCT00833469|P1|Participant Flow|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
993112|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
993113|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
993114|NCT00833469|O1|Outcome|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
993115|NCT00833469|E1|Reported Event|Escitalopram|Flexible dose escitalopram 10mg once daily by mouth (maximum of 20mg, minimum of 5mg, per the investigator's discretion).
993116|NCT00833443|B3|Baseline|Total|Total of all reporting groups
993117|NCT00833443|B2|Baseline|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
993118|NCT00833443|B1|Baseline|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
993119|NCT00833443|P2|Participant Flow|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
993120|NCT00833443|P1|Participant Flow|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
993121|NCT00833443|O2|Outcome|NOT Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication NON-adherence
993122|NCT00833443|O1|Outcome|Medication Adherent|Participants in the bupropion group with a week 6 bupropion/hydroxybupropion plasma levels suggesting medication adherence
993123|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
993124|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
993125|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
993146|NCT00833417|E1|Reported Event|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993147|NCT00833365|B3|Baseline|Total|Total of all reporting groups
993199|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993200|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993126|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
993127|NCT00833443|O2|Outcome|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
993128|NCT00833443|O1|Outcome|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
993129|NCT00833443|E2|Reported Event|Sugar Pill|Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks.
993130|NCT00833443|E1|Reported Event|Bupropion|"Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days.~Bupropion: Bupropion dose will start at 150 mg per day (one 150 mg sustained release tablet per day) for days 1-3 of the first week. The dose will then be increased to 300 mg per day (one 150 mg sustained release tablet twice daily) on day 4 and will remain 300 mg per day until the last week of the medication phase, when the dose will be decreased to 150 mg per day (one 150 mg sustained release tablet per day) for the last three days. The medication treatment phase is for 12 weeks."
993131|NCT00833417|B3|Baseline|Total|Total of all reporting groups
993132|NCT00833417|B2|Baseline|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993133|NCT00833417|B1|Baseline|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993134|NCT00833417|P2|Participant Flow|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993135|NCT00833417|P1|Participant Flow|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993136|NCT00833417|O1|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993137|NCT00833417|O1|Outcome|Metastatic and Locally Advanced BCC Cohorts|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993138|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993139|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993140|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993141|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993142|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993143|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993144|NCT00833417|O2|Outcome|Locally Advanced BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993145|NCT00833417|O1|Outcome|Metastatic BCC Cohort|Patients received vismodegib 150 mg orally once daily until disease progression; intolerable toxicity, most probably attributable to vismodegib; or withdrawal from the study.
993197|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993148|NCT00833365|B2|Baseline|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
993149|NCT00833365|B1|Baseline|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
993150|NCT00833365|P2|Participant Flow|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
993151|NCT00833365|P1|Participant Flow|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
993152|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
993153|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
993154|NCT00833365|O2|Outcome|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
993155|NCT00833365|O1|Outcome|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
993156|NCT00833365|E2|Reported Event|Late Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen after infant has reached 96 hrs old but before the infant reaches 10 days old.~Ibuprofen: Initial dose of ibuprofen is 10 mg/kg and then repeated every 24 hours times two with doses of 5 mg/kg"
993157|NCT00833365|E1|Reported Event|Early Treatment|"Infants randomized to this group will receive their initial dose of ibuprofen prior to reaching 96 hrs old~Ibuprofen: Ibuprofen 10 mg/kg/dose for one dose, then repeated 24 hrs later at 5 mg/kg/dose and repeated 24 hrs later at 5 mg/kg/dose"
993158|NCT00833248|B3|Baseline|Total|Total of all reporting groups
993159|NCT00833248|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993160|NCT00833248|B1|Baseline|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993161|NCT00833248|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993162|NCT00833248|P1|Participant Flow|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993163|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993164|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993165|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993166|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993167|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993168|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993198|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993169|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993170|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993171|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993172|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993173|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993174|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993175|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993176|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993177|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993178|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993179|NCT00833248|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993180|NCT00833248|O1|Outcome|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993181|NCT00833248|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|"On Day 0, the participants began once-daily oral (p.o.) treatment with bicalutamide as anti-androgen flare protection. This treatment continued for 2 weeks after the first dose of goserelin (i.e. 17 days in total).~On Day 3, the first goserelin implant was inserted s.c. into the abdominal wall. The second and third doses of goserelin were administered on Days 31 and 59, respectively."
993182|NCT00833248|E1|Reported Event|Degarelix 240 mg/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The second and third doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections on Days 28 and 56, respectively.
993183|NCT00833092|B3|Baseline|Total|Total of all reporting groups
993184|NCT00833092|B2|Baseline|Magnesium|300 milligrams of magnesium daily
993185|NCT00833092|B1|Baseline|Sugar Pill|zero magnesium supplementation
993186|NCT00833092|P2|Participant Flow|Magnesium|300 milligrams of magnesium daily
993187|NCT00833092|P1|Participant Flow|Sugar Pill|zero magnesium supplementation
993188|NCT00833092|O2|Outcome|Magnesium|300 milligrams of magnesium daily
993189|NCT00833092|O1|Outcome|Sugar Pill|zero magnesium supplementation
993190|NCT00833092|E2|Reported Event|Magnesium|300 milligrams of magnesium daily
993191|NCT00833092|E1|Reported Event|Sugar Pill|zero magnesium supplementation
993192|NCT00833053|B3|Baseline|Total|Total of all reporting groups
993193|NCT00833053|B2|Baseline|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993194|NCT00833053|B1|Baseline|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993195|NCT00833053|P2|Participant Flow|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993196|NCT00833053|P1|Participant Flow|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993226|NCT00833027|O1|Outcome|Sitagliptin 100mg|
993201|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993202|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993203|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993204|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993205|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993206|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993207|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993208|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993209|NCT00833053|O2|Outcome|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993210|NCT00833053|O1|Outcome|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993211|NCT00833053|E2|Reported Event|IFX q 8 Weeks + MTX|Infliximab 5mg/kg administered every 8 weeks in combination with methotrexate 7.5 mg orally once weekly.
993212|NCT00833053|E1|Reported Event|IFX q 6 Weeks|Infliximab 5 mg/kg administered every 6 weeks.
993213|NCT00833040|B1|Baseline|Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to the effective dosage of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken as needed for breakthrough pain.~During the Double-Blind Phase, patients were then randomized to one of six treatment sequences, each of which included seven active (dosage determined in Titration Phase) and three placebo doses taken in random order per. One NanoTab™ was taken as needed for breakthrough pain."
993214|NCT00833040|P6|Participant Flow|Sequence 6|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 6 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 10th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
993215|NCT00833040|P5|Participant Flow|Sequence 5|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 5 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 6th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
993216|NCT00833040|P4|Participant Flow|Sequence 4|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 4 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 3rd, 5th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
993217|NCT00833040|P3|Participant Flow|Sequence 3|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 3 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 5th, and 9th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
993218|NCT00833040|P2|Participant Flow|Sequence 2|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 2 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 8th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
993219|NCT00833040|P1|Participant Flow|Sequence 1|"Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). Patients were then randomized to one of six sequences in the Double Blind Phase in which they took ten doses of study drug.~Double-Blind Phase/Sequence 1 - Patients took a dose of study drug, as needed for breakthrough pain, as follows: placebo treatments for the 2nd, 4th, and 7th episode of breakthrough pain and ARX-F02 (sufentanil) treatments for all other episodes of breakthrough pain (dosage of sufentanil determined in the Titration Phase)."
993220|NCT00833040|O2|Outcome|Double Blind Phase of 3 Pbo Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
993221|NCT00833040|O1|Outcome|Double Blind Phase of 7 Sufentanil Tablets|Open Label Titration Phase - Each patient determined the effective dosage of sufentanil for their pain (20, 30, 40, 60 or 80 mcg). In the Double-Blind Phase, each patient was randomized to one of six treatment sequences in which the patient took seven active sufentanil doses (dosage determined in the Titration Phase) and three placebo doses as needed for breakthrough pain.
993222|NCT00833040|E1|Reported Event|Titration of Sufentanil Followed by Sufentanil and PBO|"During the Titration Phase, patients titrated to their personal effective strength of sufentanil NanoTab™(20, 30, 40, 60 or 80 mcg). One sufentanil NanoTab™ was taken for each episode of breakthrough pain.~During the Double-Blind Phase, patients were randomized to one of six treatment sequences, each of which included seven active doses (the strength determined in Titration Phase) and three placebo doses. The ten doses were in random order. One NanoTab™ was taken for each episode of breakthrough pain."
993223|NCT00833027|B1|Baseline|Sitagliptin 100mg|
993224|NCT00833027|P1|Participant Flow|Sitagliptin 100mg|
993225|NCT00833027|O1|Outcome|Sitagliptin 100mg|
993228|NCT00832975|B1|Baseline|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
993229|NCT00832975|P1|Participant Flow|St Jude Medical ICD/CRT-D|St Jude Medical Implantable Cardioverter Defibrillator (ICD) / Cardiac Resynchronization Therapy-Defibrillator (CRT-D) Device implanted patients
993230|NCT00832975|O1|Outcome|Single Arm|St Jude Medical ICD/CRT-D Device implanted patients
993231|NCT00832975|O1|Outcome|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
993232|NCT00832975|E1|Reported Event|St Jude Medical ICD/CRT-D|St Jude Medical ICD/CRT-D Device implanted patients
993233|NCT00832871|B1|Baseline|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
993234|NCT00832871|P1|Participant Flow|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
993235|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
993236|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
993237|NCT00832871|O1|Outcome|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
993238|NCT00832871|E1|Reported Event|Mifepristone|"200 mg RU-486 (Mifepristone) daily~Mifepristone: Mifepristone 200 mg will be administered orally"
993239|NCT00832819|B4|Baseline|Total|Total of all reporting groups
993240|NCT00832819|B3|Baseline|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993241|NCT00832819|B2|Baseline|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993242|NCT00832819|B1|Baseline|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (Area under the curve (AUC) 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993243|NCT00832819|P3|Participant Flow|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993244|NCT00832819|P2|Participant Flow|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993245|NCT00832819|P1|Participant Flow|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993246|NCT00832819|O1|Outcome|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993247|NCT00832819|E3|Reported Event|E7080 4 mg BID (Expansion)|Dosage of E7080 for expansion cohort was determined based on the maximum tolerated dose (MTD). The MTD for E7080 with with the combination of carboplatin and paclitaxel was 4 mg BID (Arm 1). For the expansion cohort, run-in treatment (Cycle 0) was not performed and E7080 treatment (4 mg BID) began from Cycle 1 but up to 6 Cycles with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993248|NCT00832819|E2|Reported Event|E7080 6 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 6 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993249|NCT00832819|E1|Reported Event|E7080 4 mg BID (Dose Escalation)|E7080 mono-therapy (initial dose was 4 mg BID) was orally administered twice daily for 7 days in run-in period (Cycle 0); subsequently from Cycle 1 but up to 6 Cycles, E7080 treatment was continued with the combination of carboplatin (AUC 6.0 min/mg/mL) and paclitaxel (200 mg/m2) on Day 1 every 3 weeks.
993250|NCT00832650|B4|Baseline|Total|Total of all reporting groups
993251|NCT00832650|B3|Baseline|Solifenacin|Solifenacin 10 mg capsule once daily
993252|NCT00832650|B2|Baseline|Placebo|Matched placebo tablet or capsule
993253|NCT00832650|B1|Baseline|Fesoterodine|Fesoterodine 8 mg tablet once daily
993254|NCT00832650|P3|Participant Flow|Solifenacin|Solifenacin 10 mg capsule once daily
993255|NCT00832650|P2|Participant Flow|Placebo|Matched placebo tablet or capsule
993256|NCT00832650|P1|Participant Flow|Fesoterodine|Fesoterodine 8 mg tablet once daily
993257|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993258|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993259|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993260|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993261|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993262|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993263|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993264|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993265|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993268|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993269|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993270|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993271|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993272|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993273|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993274|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993275|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993276|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993277|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993278|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993279|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993280|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993281|NCT00832650|O3|Outcome|Solifenacin|Solifenacin 10 mg capsule once daily
993282|NCT00832650|O2|Outcome|Placebo|Matched placebo tablet or capsule
993283|NCT00832650|O1|Outcome|Fesoterodine|Fesoterodine 8 mg tablet once daily
993284|NCT00832650|E3|Reported Event|Solifenacin|Solifenacin 10 mg capsule once daily
993285|NCT00832650|E2|Reported Event|Placebo|Matched placebo tablet or capsule
993286|NCT00832650|E1|Reported Event|Fesoterodine|Fesoterodine 8 mg tablet once daily
993287|NCT00832637|B1|Baseline|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993288|NCT00832637|P1|Participant Flow|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993289|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993290|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993291|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993309|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
993793|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993424|NCT00832130|P2|Participant Flow|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993292|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993293|NCT00832637|O1|Outcome|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993294|NCT00832637|E1|Reported Event|Gemcitabine, Cisplatin, Erlotinib|"Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.~Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.~Erlotinib: 100 mg orally daily.~Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment."
993295|NCT00832624|B1|Baseline|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
993296|NCT00832624|P1|Participant Flow|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
993297|NCT00832624|O1|Outcome|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
993298|NCT00832624|E1|Reported Event|Sitagliptin 100 mg|Sitagliptin, 100 mg, 1 Tablet, once a day, for 18 weeks
993299|NCT00832585|B1|Baseline|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
993300|NCT00832585|P1|Participant Flow|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
993301|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
993302|NCT00832585|O1|Outcome|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
993303|NCT00832585|E1|Reported Event|Alefacept|Amevive® has been shown to be a safe and effective agent in the treatment of psoriasis but may prove useful in treating atopic dermatitis. Unlike other “biologics” for the treatment of skin diseases, the use of alefacept is not associated with increased infection, congestive heart failure, demyelinating disorders or lupus- like syndromes. The dose for Alefacept is 15mg, the dosage form is intramuscular injection (IM), and the frequency of administration is once a week for 12 weeks.
993304|NCT00832572|B3|Baseline|Total|Total of all reporting groups
993305|NCT00832572|B2|Baseline|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
993306|NCT00832572|B1|Baseline|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
993307|NCT00832572|P2|Participant Flow|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
993308|NCT00832572|P1|Participant Flow|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
993366|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
993310|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
993311|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
993312|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
993313|NCT00832572|O2|Outcome|Ranolazine/Placebo|Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2).
993314|NCT00832572|O1|Outcome|Placebo/Ranolazine|Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2).
993315|NCT00832572|E4|Reported Event|Ranolazine/Placebo, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving placebo).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
993316|NCT00832572|E3|Reported Event|Ranolazine/Placebo, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving ranolazine).~Participants were randomized to receive ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 1 to 6 (Period 1), then placebo to match ranolazine during Weeks 7 to 12 (Period 2)."
993317|NCT00832572|E2|Reported Event|Placebo/Ranolazine, Period 2|"Adverse events for this reporting group are those occurring during Period 2 (participants were receiving ranolazine).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
993318|NCT00832572|E1|Reported Event|Placebo/Ranolazine, Period 1|"Adverse events for this reporting group are those occurring during Period 1 (participants were receiving placebo).~Participants were randomized to receive placebo to match ranolazine during Weeks 1 to 6 (Period 1), then ranolazine (500 mg twice a day for 3 weeks, followed by either 500 mg or 1000 mg twice a day for 3 weeks) during Weeks 7 to 12 (Period 2)."
993319|NCT00832520|B1|Baseline|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
993320|NCT00832520|P1|Participant Flow|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
993321|NCT00832520|O1|Outcome|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
993322|NCT00832520|E1|Reported Event|Remeron (Mirtazapine)|Mirtazapine 15 mg orally at bed time for 8 weeks
993323|NCT00832455|B1|Baseline|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
993324|NCT00832455|P1|Participant Flow|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
993325|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|
993326|NCT00832455|O2|Outcome|Montelukast ITT at Week 8|
993327|NCT00832455|O1|Outcome|Montelukast ITT at Week 4|
993328|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
993329|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
993330|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
993331|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
993332|NCT00832455|O4|Outcome|Montelukast ITT at Week 12|
993333|NCT00832455|O3|Outcome|Montelukast ITT at Week 8|
993334|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|
993335|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|
993336|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
993337|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
993338|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
993339|NCT00832455|O3|Outcome|Montelukast ITT at Week 12|ITT population, receiving montelukast 4 or 5 mg/day
993340|NCT00832455|O2|Outcome|Montelukast ITT at Week 4|ITT population, receiving montelukast 4 or 5 mg/day
993341|NCT00832455|O1|Outcome|Montelukast ITT at Week 0|ITT population, receiving montelukast 4 or 5 mg/day
993342|NCT00832455|E1|Reported Event|Montelukast|Montelukast 4-5 mg for 12 weeks, oral tablet
993343|NCT00832416|B5|Baseline|Total|Total of all reporting groups
993344|NCT00832416|B4|Baseline|4: Placebo|
993345|NCT00832416|B3|Baseline|3: Tramadol Once A Day 300mg|
993346|NCT00832416|B2|Baseline|2: Tramadol Once A Day 200mg|
993347|NCT00832416|B1|Baseline|1: Tramadol Once A Day 100mg|
993348|NCT00832416|P4|Participant Flow|4: Placebo|
993349|NCT00832416|P3|Participant Flow|3: Tramadol Once A Day 300mg|
993350|NCT00832416|P2|Participant Flow|2: Tramadol Once A Day 200mg|
993351|NCT00832416|P1|Participant Flow|1: Tramadol Once A Day 100mg|
993352|NCT00832416|O4|Outcome|4: Placebo|
993353|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
993354|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
993355|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
993356|NCT00832416|O4|Outcome|4: Placebo|
993357|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
993358|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
993359|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
993360|NCT00832416|O4|Outcome|4: Placebo|
993361|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
993362|NCT00832416|O2|Outcome|2: Tramadol Once A Day 200mg|
993363|NCT00832416|O1|Outcome|1: Tramadol Once A Day 100mg|
993364|NCT00832416|O4|Outcome|4: Placebo|
993365|NCT00832416|O3|Outcome|3: Tramadol Once A Day 300mg|
993389|NCT00832390|B3|Baseline|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
993390|NCT00832390|B2|Baseline|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
993391|NCT00832390|B1|Baseline|Sitagliptin 100 mg q.d. (Once Daily)|
993392|NCT00832390|P3|Participant Flow|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
993393|NCT00832390|P2|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
993394|NCT00832390|P1|Participant Flow|Sitagliptin 100 mg q.d. (Once Daily)|
993395|NCT00832390|O3|Outcome|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
993396|NCT00832390|O2|Outcome|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
993397|NCT00832390|O1|Outcome|Sitagliptin 100 mg q.d. (Once Daily)|
993398|NCT00832390|E3|Reported Event|Standard Care Regimen|"Patients in the standard care group were to receive usual care per practice but not to be treated with sitagliptin or another DPP-4 inhibitor. As prespecified in the protocol, no efficacy was to be assessed in this group."
993399|NCT00832390|E2|Reported Event|Sitagliptin 100 mg q.d. (Once Daily) and Metformin|
993400|NCT00832390|E1|Reported Event|Sitagliptin 100 mg q.d. (Once Daily)|
993401|NCT00832377|B1|Baseline|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
993402|NCT00832377|P1|Participant Flow|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
993403|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
993404|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
993405|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
993406|NCT00832377|O1|Outcome|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
993407|NCT00832377|E1|Reported Event|Timolol/Dorzolamide|Timolol/Dorzolamide, 1 drop, twice daily, for 12 weeks
993408|NCT00832338|B1|Baseline|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
993409|NCT00832338|P1|Participant Flow|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg twice daily (BID) PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
993410|NCT00832338|O1|Outcome|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
993411|NCT00832338|E1|Reported Event|Docetaxel With Cytoxan|"Patients will be treated with docetaxel at 75 mg/m² concomitantly with cytoxan 600 mg/m² (TC) IV D1 every 3 weeks for 6 cycles. Due to known toxicity of docetaxel, all patients require dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel to minimize hypersensitivity reactions and fluid retention.~Docetaxel with Cytoxan: Docetaxel 75 mg/m² plus cytoxan 600 mg/m² every 3 weeks for 6 cycles.~Dexamethasone: Dexamethasone 4 mg BID PO for 3 consecutive days starting 12-24 hours prior to each dose of docetaxel."
993412|NCT00832299|B1|Baseline|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
993413|NCT00832299|P1|Participant Flow|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
993414|NCT00832299|O1|Outcome|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
993415|NCT00832299|E1|Reported Event|6 Cycles of FOLFOX Pre and Post TME|"total mesorectal excision (TME) : TME will be done 4-6 weeks after 6 cycles of neo-adjuvant FOLFOX.~FOLFOX : 6 cycles of neo-adjuvant mFOLFOX6"
993416|NCT00832260|B1|Baseline|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
993417|NCT00832260|P1|Participant Flow|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
993418|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
993419|NCT00832260|O1|Outcome|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
993420|NCT00832260|E1|Reported Event|Zephyr Pacemaker|Non-randomized study. Patients with indication of a Pacemaker model Zephyr of St. Jude Medical
993421|NCT00832130|B3|Baseline|Total|Total of all reporting groups
993422|NCT00832130|B2|Baseline|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993423|NCT00832130|B1|Baseline|Manual Mini System|Treatment with experimental Manual Mini System
993794|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993425|NCT00832130|P1|Participant Flow|Manual Mini System|Treatment with experimental Manual Mini System
993426|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993427|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993428|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993429|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993430|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993431|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993432|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993433|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993434|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993435|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993436|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993437|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993438|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993439|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993440|NCT00832130|O2|Outcome|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993441|NCT00832130|O1|Outcome|Manual Mini System|Treatment with experimental Manual Mini System
993442|NCT00832130|E2|Reported Event|Warm Compress Therapy|Control group receiving warm compress therapy in first study phase and crossover Manual Mini System treatment in second study phase
993443|NCT00832130|E1|Reported Event|Manual Mini System|Treatment with experimental Manual Mini System
993444|NCT00832117|B3|Baseline|Total|Total of all reporting groups
993445|NCT00832117|B2|Baseline|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993446|NCT00832117|B1|Baseline|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993447|NCT00832117|P1|Participant Flow|All Enrolled Participants|Participants received both ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 and ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle.
993448|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993449|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993450|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993451|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993452|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993453|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993454|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993455|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993456|NCT00832117|O1|Outcome|All Treated Participants|All participants who received at least 1 dose of either ixabepilone or carboplatin
993457|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993458|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993795|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993498|NCT00832000|O2|Outcome|Placebo|Average time to open the fist after forced hand grip for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
993459|NCT00832117|O2|Outcome|32mg/m^2+Cis 80mg/m^2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993460|NCT00832117|O1|Outcome|Ixa 32 mg/m^2+Cis 60 mg/m^2|6 participants with solid tumors (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) with NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993461|NCT00832117|E2|Reported Event|Ixa 32 mg/m2 +Cis 80 mg/m2|5 participants in the dose-escalation phase with solid tumors (refractory to prior therapy) received ixa 32mg/m^2+cis 80mg/m^2, administered intravenously on Day 1 of a 21 day cycle
993462|NCT00832117|E1|Reported Event|Ixa 32 mg/m2 + Cis 60 mg/m2|6 participants with solid tumor (refractory to prior therapy) in the dose-escalation phase and 18 participants (with no prior chemotherapeutic treatment) for NSCLC in the dose-expansion phase received ixabepilone (ixa) 32 mg/m^2+ cisplatin (cis) 60 mg/m^2 administered intravenously on Day 1 of a 21 day cycle
993463|NCT00832091|B3|Baseline|Total|Total of all reporting groups
993464|NCT00832091|B2|Baseline|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
993465|NCT00832091|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
993466|NCT00832091|P2|Participant Flow|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
993467|NCT00832091|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
993468|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
993469|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
993470|NCT00832091|O2|Outcome|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
993471|NCT00832091|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
993472|NCT00832091|E2|Reported Event|Thymosin Beta 4 (Tβ4) at 3 Doses|0.01% Tβ4 weight by weight (w/w), 0.03% Tβ4 w/w, 0.1% Tβ4 w/w
993473|NCT00832091|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
993474|NCT00832078|B1|Baseline|Entire Study Population|
993475|NCT00832078|P2|Participant Flow|Group B|Test day 1 first SC then SCCM; Test day 2 first SCCM then SC; this gives 4 catherizations per participant
993476|NCT00832078|P1|Participant Flow|Group A|Test day 1: first SCCM then SC; Test day 2: first SC then SCCM; this gives 4 catherizations per participant
993477|NCT00832078|O2|Outcome|Standard Catheter SC|The Stanard catheter SpeediCath (SC)
993478|NCT00832078|O1|Outcome|Test Catheter SCCM|The Test catheter SpeediCath Compact Male (SCCM)
993479|NCT00832078|E2|Reported Event|Standard Catheter|
993480|NCT00832078|E1|Reported Event|Test Catheter|
993481|NCT00832000|B1|Baseline|All Study Participants|All participants received all inerventions; therefore, we combined all participants into one Arm/Group.
993482|NCT00832000|P2|Participant Flow|Placebo Then Mexiletine|"30 Participants will receive placebo for 4 weeks, then no intervention for 1 week, and finally mexiletine for 4 weeks.~Included in analysis* 29 patients~*Modified intention to treat analysis. 1 subject in each not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period."
993483|NCT00832000|P1|Participant Flow|Mexiletine Then Placebo|"29 Participants will receive mexiletine for 4 weeks, then no intervention for 1 week, and finally placebo for 4 weeks.~Included in anaysis*: 28 patients~*Modified intention to treat analysis. 1 subject in each group not included in primary analysis due to failure to make any calls to the IVR system for stiffness in either period"
993484|NCT00832000|O4|Outcome|Placebo - Period 2|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993485|NCT00832000|O3|Outcome|Mexiletine - Period 2|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993486|NCT00832000|O2|Outcome|Placebo - Period 1|SF-36 mental composite for participants receiving placebo capsules orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993487|NCT00832000|O1|Outcome|Mexiletine - Period 1|SF-36 mental composite for participants receiving mexiletine capsules 200 mg orally three times daily in period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993488|NCT00832000|O2|Outcome|Placebo|SF-36 physical composite score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
993489|NCT00832000|O1|Outcome|Mexiletine|SF-36 physical composite score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
993490|NCT00832000|O2|Outcome|Placebo|INQoL summary score for participants receiving placebo capsules orally three times daily either in period 1 or period 2
993491|NCT00832000|O1|Outcome|Mexiletine|INQoL summary score for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
993492|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude ( as a percentage of baseline measurement) for participants receiving placebo capsules orally three times daily either in period 1 or period 2
993493|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percentage of baseline measreument) for participants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
993494|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
993495|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right TA for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
993496|NCT00832000|O2|Outcome|Placebo|Average time to open eyes after forced eye closure for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
993497|NCT00832000|O1|Outcome|Mexiletine|Average time to open eyes after forced eye closure for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
993499|NCT00832000|O1|Outcome|Mexiletine|Average time to open the fist after forced hand grip for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
993500|NCT00832000|O2|Outcome|Placebo|Graded myotonia in right ADM for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
993501|NCT00832000|O1|Outcome|Mexiletine|Graded myotonia in right ADM for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
993502|NCT00832000|O2|Outcome|Placebo|Post exercise CMAP amplitude (as a percento f baseline measurement) for particpants receiving mexiletine capsules orally three times daily either in period 1 or period 2
993503|NCT00832000|O1|Outcome|Mexiletine|Post exercise CMAP amplitude (as a percent of baseline measurement) for particpants receiving mexiletine capsules 200 mg orally three times daily either in period 1 or period 2
993504|NCT00832000|O2|Outcome|Placebo|Average 90% to 5% hand grip relaxation time for particpants receiving placebo capsules orally three times daily either in period 1 or period 2
993505|NCT00832000|O1|Outcome|Mexiletine|Average 90% to 5% hand grip relaxation time for particpants receiving mexiletine 200 mg capsules orally three times daily either in period 1 or period 2
993506|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced tiredness on placebo capsules orally three times daily in either period 1 or period 2.
993507|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced tiredness on mexiletine 200 mg capsules orally three times daily in either period 1 or period 2.
993508|NCT00832000|O2|Outcome|Placebo|Particiapnts who experienced weakness on placebo capsules orally three times daily in either period 1 or period 2.
993509|NCT00832000|O1|Outcome|Mexiletine|Particiapnts who experienced weakness on mexiletine capsules 200 mg orally three times daily in either period 1 or period 2.
993510|NCT00832000|O2|Outcome|Placebo|Participants experiencing pain on placebo capsules orally three times dailyin period 1 or period 2
993511|NCT00832000|O1|Outcome|Mexiletine|Participants experiencing pain on mexiletine capsules 200 mg orally three times daily in period 1 or period 2
993512|NCT00832000|O4|Outcome|Placebo - Period 2|Placebo capsules orally three times dailyperiod 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993513|NCT00832000|O3|Outcome|Mexiletine - Period 2|Mexiletine capsules 200 mg orally three times daily period 2. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993514|NCT00832000|O2|Outcome|Placebo - Period 1|Placebo capsules orally three times dailyperiod 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993515|NCT00832000|O1|Outcome|Mexiletine - Period 1|Mexiletine capsules 200 mg orally three times daily period 1. Due to an interaction between period and treatment the primary outcome was presented separately for periods 1 and 2.
993516|NCT00832000|E2|Reported Event|Placebo Treatment|Adverse events that occurred when patients were taking mexiletine.
993517|NCT00832000|E1|Reported Event|Mexiletine Treatment|Adverse events that occurred when patients were taking placebo.
993518|NCT00831987|B3|Baseline|Total|Total of all reporting groups
993519|NCT00831987|B2|Baseline|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993520|NCT00831987|B1|Baseline|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993521|NCT00831987|P2|Participant Flow|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993522|NCT00831987|P1|Participant Flow|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993523|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993524|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993525|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993526|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993527|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993528|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993529|NCT00831987|O2|Outcome|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993530|NCT00831987|O1|Outcome|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993531|NCT00831987|E2|Reported Event|Fluzone® Vaccine Group - Age ≥ 60 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993532|NCT00831987|E1|Reported Event|Fluzone® Vaccine Group - Age 18-59 Years|Participants received 1 dose of Fluzone® vaccine on Day 0.
993533|NCT00831844|B11|Baseline|Total|Total of all reporting groups
993534|NCT00831844|B10|Baseline|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993535|NCT00831844|B9|Baseline|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993536|NCT00831844|B8|Baseline|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993796|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993641|NCT00831493|B1|Baseline|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
993537|NCT00831844|B7|Baseline|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993538|NCT00831844|B6|Baseline|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993539|NCT00831844|B5|Baseline|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993540|NCT00831844|B4|Baseline|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993541|NCT00831844|B3|Baseline|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993542|NCT00831844|B2|Baseline|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993543|NCT00831844|B1|Baseline|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993544|NCT00831844|P10|Participant Flow|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993545|NCT00831844|P9|Participant Flow|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993546|NCT00831844|P8|Participant Flow|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993547|NCT00831844|P7|Participant Flow|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993548|NCT00831844|P6|Participant Flow|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -meta-iodobenzylguanidine (MIBG) Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993549|NCT00831844|P5|Participant Flow|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993550|NCT00831844|P4|Participant Flow|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993551|NCT00831844|P3|Participant Flow|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993552|NCT00831844|P2|Participant Flow|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993553|NCT00831844|P1|Participant Flow|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993554|NCT00831844|O10|Outcome|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993797|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993555|NCT00831844|O9|Outcome|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993556|NCT00831844|O8|Outcome|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993557|NCT00831844|O7|Outcome|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993558|NCT00831844|O6|Outcome|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993559|NCT00831844|O5|Outcome|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993560|NCT00831844|O4|Outcome|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993561|NCT00831844|O3|Outcome|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993562|NCT00831844|O2|Outcome|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993563|NCT00831844|O1|Outcome|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993564|NCT00831844|E10|Reported Event|Group 10 - Recurrent or Refractory Retinoblastoma|"Group 10 - Recurrent or Refractory Retinoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993565|NCT00831844|E9|Reported Event|Group 9 - Recurrent or Refractory Wilms Tumor|"Group 9 - Recurrent or Refractory Wilms Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993566|NCT00831844|E8|Reported Event|Group 8 - Recurrent Osteosarcoma|"Group 8 - Recurrent Osteosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993567|NCT00831844|E7|Reported Event|Grp 7-Neuroblastoma With Measurable Disease|"Group 7 - Recurrent or Refractory Neuroblastoma -With Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993568|NCT00831844|E6|Reported Event|Grp 6 - Neuroblastoma-MIBG Positive Without Measurable Disease|"Group 6 - Recurrent or Refractory Neuroblastoma -MIBG Positive Without Measurable Disease. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993569|NCT00831844|E5|Reported Event|Grp 5-Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor|"Group 5 - Recurrent or Refractory Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993570|NCT00831844|E4|Reported Event|Grp 4-Recurrent or Refractory Adrenocortical Carcinoma|"Group 4 - Recurrent or Refractory Adrenocortical Carcinoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993571|NCT00831844|E3|Reported Event|Group 3 - Recurrent or Refractory Rhabdomyosarcoma|"Group 3 - Recurrent or Refractory Rhabdomyosarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993572|NCT00831844|E2|Reported Event|Group 2 - Recurrent or Refractory Synovial Sarcoma|"Group 2 - Recurrent or Refractory Synovial Sarcoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993639|NCT00831675|E2|Reported Event|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993573|NCT00831844|E1|Reported Event|Group 1 - Recurrent or Refractory Hepatoblastoma|"Group 1 - Recurrent or Refractory Hepatoblastoma. Patients receive cixutumumab IV over 1 hour on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 24 courses in the absence of disease progression or unacceptable toxicity.~cixutumumab: Given IV~laboratory biomarker analysis: Correlative studies"
993574|NCT00831779|B3|Baseline|Total|Total of all reporting groups
993575|NCT00831779|B2|Baseline|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
993576|NCT00831779|B1|Baseline|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
993577|NCT00831779|P2|Participant Flow|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
993578|NCT00831779|P1|Participant Flow|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
993579|NCT00831779|O2|Outcome|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
993580|NCT00831779|O1|Outcome|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
993581|NCT00831779|O2|Outcome|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
993582|NCT00831779|O1|Outcome|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
993583|NCT00831779|E2|Reported Event|Dapagliflozin 5 mg + Background Anti-Diabetes Medication|Dapagliflozin tablets, oral, once daily, 12 weeks
993584|NCT00831779|E1|Reported Event|Placebo + Background Anti-Diabetes Medication|Placebo tablets, oral, once daily, 12 weeks
993585|NCT00831766|B3|Baseline|Total|Total of all reporting groups
993586|NCT00831766|B2|Baseline|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
993587|NCT00831766|B1|Baseline|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
993588|NCT00831766|P2|Participant Flow|Phase II: Treatment at MTD|"Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: Maximum Tolerated Dose (MTD).~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
993589|NCT00831766|P1|Participant Flow|Phase I: Dose Escalation|"Induction: A dose escalation plan for induction therapy using a standard 3x3 design with dose escalation of Lenalidomide only, to determine maximum tolerated dose (MTD). Idarubicin and cytarabine doses will be fixed.~Idarubicin: 12 mg/m^2.~Cytarabine: 200 mg/m^2.~Lenalidomide: According to dose escalation levels. Level 1: 5 mg/d; Level 2: 10 mg/d; Level 3: 15 mg/d; Level 4: 20 mg/d; Level 5: 25 mg/d.~Idarubicin: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Cytarabine: Intravenous infusion of Idarubicin as outlined in Phase I and Phase II Treatment Arms.~Lenalidomide (Revlimid®): Lenalidomide as outlined in Phase I and Phase II Treatment Arms."
993590|NCT00831766|O1|Outcome|All Participants Treated at MTD|All participants, regardless of Phase who were treated at the maximum tolerated dose (MTD).
993591|NCT00831766|O1|Outcome|Phase I Participants|Dose escalation group.
993592|NCT00831766|E2|Reported Event|Phase II: Treatment at MTD|Participants enrolled during Phase II.
993593|NCT00831766|E1|Reported Event|Phase I: Dose Escalation|Participants enrolled during Phase I.
993594|NCT00831753|B3|Baseline|Total|Total of all reporting groups
993595|NCT00831753|B2|Baseline|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
993596|NCT00831753|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
993597|NCT00831753|P2|Participant Flow|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
993598|NCT00831753|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
993599|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
993600|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
993601|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
993640|NCT00831675|E1|Reported Event|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993798|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993602|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
993603|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
993604|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
993605|NCT00831753|O2|Outcome|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
993606|NCT00831753|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
993607|NCT00831753|E2|Reported Event|Infanrix Hexa™ Group|All participants received a 3-dose primary series of Infanrix hexa™ vaccine, with 1 dose each at 2, 4, and 6 months of age, respectively.
993608|NCT00831753|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|All participants received a 3-dose primary series of diphtheria, tetanus, pertussis (2-component acellular), recombinant hepatitis B (Hep B) Hansenula polymorpha and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T) combined vaccine. A dose at 2, 4, and 6 months of age, respectively.
993609|NCT00831701|B3|Baseline|Total|Total of all reporting groups
993610|NCT00831701|B2|Baseline|Placebo Treatment|Patients received Placebo pill once daily
993611|NCT00831701|B1|Baseline|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993612|NCT00831701|P2|Participant Flow|Placebo Treatment|Patients received Placebo pill once daily
993613|NCT00831701|P1|Participant Flow|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993614|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
993615|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993616|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
993617|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993618|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
993619|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993620|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
993621|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993622|NCT00831701|O2|Outcome|Placebo Treatment|Patients received Placebo pill once daily
993623|NCT00831701|O1|Outcome|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993624|NCT00831701|E2|Reported Event|Placebo Treatment|Patients received Placebo pill once daily
993625|NCT00831701|E1|Reported Event|Tamsulosin Treatment|Patients received one pill of Tamsulosin 400 micrograms once daily
993626|NCT00831675|B3|Baseline|Total|Total of all reporting groups
993627|NCT00831675|B2|Baseline|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993628|NCT00831675|B1|Baseline|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993629|NCT00831675|P2|Participant Flow|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993630|NCT00831675|P1|Participant Flow|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993631|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993632|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993633|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993634|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993635|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993636|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993637|NCT00831675|O2|Outcome|Toddlers ≥12 Months|Participants aged ≥ 12 to < 36 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993638|NCT00831675|O1|Outcome|Infants <12 Months|Participants aged ≥ 6 to < 12 months at enrollment and received 0.25 mL intramuscular injection of Fluzone® vaccine on Day 0 and on Day 28, respectively.
993799|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993642|NCT00831493|P1|Participant Flow|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
993643|NCT00831493|O1|Outcome|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
993644|NCT00831493|E1|Reported Event|Vorinostat + Radiation Therapy|Vorinostat starting dose 200 mg orally once daily, Monday to Friday, Weeks 1 to 6; Radiation Therapy Dose of 50.4 Gray (Gy) in 1.8 Gy fractions in 28 fractions, Monday to Friday, Weeks 1 to 6.
993645|NCT00831480|B1|Baseline|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
993646|NCT00831480|P1|Participant Flow|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
993647|NCT00831480|O1|Outcome|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
993648|NCT00831480|E1|Reported Event|"Neoadjuvant Everolimus RAD001 for Advanced RCC Before Cytore"|"All subjects will take everolimus~everolimus: everolimus 10 mg PO once daily for 3-5 weeks followed by removal of the kidney. Everolimus will begin again between 2 to 4 weeks after surgery."
993649|NCT00831441|B3|Baseline|Total|Total of all reporting groups
993650|NCT00831441|B2|Baseline|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily.
993651|NCT00831441|B1|Baseline|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993652|NCT00831441|P2|Participant Flow|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
993653|NCT00831441|P1|Participant Flow|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
993654|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993655|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993656|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993657|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993658|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993659|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993660|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993661|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993662|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993663|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993664|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993665|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993666|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993667|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993668|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993669|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993670|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993671|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993672|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993673|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993674|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated at Year 2.
993675|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993676|NCT00831441|O2|Outcome|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. Study was terminated in Year 2.
993677|NCT00831441|O1|Outcome|Placebo|Placebo: Tablets, Oral, 0 mg, twice daily.
993678|NCT00831441|E2|Reported Event|Placebo BID|Placebo: Tablets, Oral, 0 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
993730|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993731|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993732|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993679|NCT00831441|E1|Reported Event|Apixaban 5 mg BID|Apixaban: Tablets, Oral, 5 mg, twice daily. The Treatment Period was planned to be completed after at least 938 participants had a primary efficacy endpoint confirmed by adjudication. After 7392 participants had been randomized into the study, an independent Data Monitoring Committee recommended that the study be terminated early due to a clinically important increase in bleeding among participants randomized to apixaban which was not offset by meaningful reductions in ischemic events. The Study terminated in Year 2.
993680|NCT00831428|B1|Baseline|Scottish Swimming Team|
993681|NCT00831428|P1|Participant Flow|Scottish Swimming Team|
993682|NCT00831428|O1|Outcome|Scottish Swimming Team|
993683|NCT00831428|E1|Reported Event|Scottish Swimming Team|
993684|NCT00831415|B1|Baseline|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
993685|NCT00831415|P1|Participant Flow|DVS SR|Desvenlafaxine succinate sustained release formulation (DVS SR) flexible dose 25 milligrams per day (mg/day) up to 100 mg/day.
993686|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
993687|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
993688|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
993689|NCT00831415|O1|Outcome|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
993690|NCT00831415|E1|Reported Event|DVS SR|DVS SR flexible dose 25 mg/day up to 100 mg/day.
993691|NCT00831389|B1|Baseline|All Study Participants|Four day inpatient study with exercise (on second or third day based on randomization) with closed loop insulin delivery system for glycemic control.
993692|NCT00831389|P1|Participant Flow|All Participants|All participants were treated and observed during in-patient visits twice during the study - two (2) in-patient study phases per subject. Each such in-patient phase was conducted for four (4) days. Insulin delivery during the first in-patient study phase was determined by either Standard of Care (OL), or autonomously by a glycemic control algorithm (CL), depending upon randomization. The exercise challenge was conducted on either the second or third day of this visit, depending upon randomization. Insulin delivery during the second in-patient study phase was the delivery mechanism not used during the 1st in-patient visit. The second in-patient study phase exercise challenge was conducted on the day not chosen for exercise during the first in-patient visit. Intervention was performed only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993693|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993694|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993695|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993696|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993697|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993698|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993699|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993700|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993701|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993702|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993703|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993704|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993705|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993706|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993707|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993708|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993709|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993710|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993711|NCT00831389|O2|Outcome|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993712|NCT00831389|O1|Outcome|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993713|NCT00831389|E2|Reported Event|Closed Loop (CL) Phase|Four day inpatient visit during which insulin administration was determined autonomously by a glycemic control algorithm, with the exception of pre-meal bolus determined by study protocol. Subject performs no adjustment to insulin dosage. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993714|NCT00831389|E1|Reported Event|Standard of Care (OL) Phase|Four day inpatient visit during which insulin administration was dictated by standard of care. Subject determines basal rate, meal bolusing, and any correction boluses using her/his normal regimen. Health Care Provider intervention only when dictated by protocol or determined necessary by the Health Care Professionals monitoring the study.
993715|NCT00831311|B3|Baseline|Total|Total of all reporting groups
993716|NCT00831311|B2|Baseline|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993717|NCT00831311|B1|Baseline|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993718|NCT00831311|P2|Participant Flow|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993719|NCT00831311|P1|Participant Flow|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993720|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993721|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993722|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993723|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993724|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993725|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993726|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993727|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993728|NCT00831311|O2|Outcome|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993729|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993800|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993733|NCT00831311|O1|Outcome|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993734|NCT00831311|E2|Reported Event|Group 2: PENTAXIM™ and ENGERIX B®|Participants received 3 doses of PENTAXIM™ (PTaP-IPV//PRP-T) and ENGERIX B® PEDIATRICO vaccines at 2, 4, and 6 months of age.
993735|NCT00831311|E1|Reported Event|Group 1: DTaP-IPV-Hep B-PRP~T|Participants received 3 doses of the DTaP-IPV-Hep B-PRP~T vaccine, 1 dose each at 2, 4, and 6 months of age.
993736|NCT00831272|B5|Baseline|Total|Total of all reporting groups
993737|NCT00831272|B4|Baseline|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
993738|NCT00831272|B3|Baseline|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
993739|NCT00831272|B2|Baseline|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
993740|NCT00831272|B1|Baseline|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
993741|NCT00831272|P4|Participant Flow|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
993742|NCT00831272|P3|Participant Flow|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
993743|NCT00831272|P2|Participant Flow|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
993744|NCT00831272|P1|Participant Flow|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
993745|NCT00831272|O4|Outcome|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
993746|NCT00831272|O3|Outcome|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
993747|NCT00831272|O2|Outcome|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
993748|NCT00831272|O1|Outcome|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
993749|NCT00831272|E4|Reported Event|Placebo Group ASN 40 Group|Placebo plus ASN 40 Carrier
993750|NCT00831272|E3|Reported Event|Naltrexone Group ASN 40 Group|Naltrexone 50mg/day and ASN 40 carrier
993751|NCT00831272|E2|Reported Event|Placebo Group ASP 40 Group|Placebo group and ASP 40 carrier
993752|NCT00831272|E1|Reported Event|Naltrexone Group ASP 40 Group|50mg/day of naltrexone and ASP 40 carrier
993753|NCT00831233|B3|Baseline|Total|Total of all reporting groups
993754|NCT00831233|B2|Baseline|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993755|NCT00831233|B1|Baseline|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993756|NCT00831233|P2|Participant Flow|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993757|NCT00831233|P1|Participant Flow|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993758|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993759|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993760|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993761|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993762|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993763|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993764|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993765|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993766|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993767|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993768|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993769|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993770|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993771|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993772|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993773|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993774|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993775|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993776|NCT00831233|O2|Outcome|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993777|NCT00831233|O1|Outcome|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993778|NCT00831233|E2|Reported Event|Goserelin (3.6 mg) + Bicalutamide (50 mg)|Goserelin (3.6 mg) + bicalutamide (50 mg)
993779|NCT00831233|E1|Reported Event|Degarelix 240 mg/80 mg|Degarelix 240 mg (40 mg/mL) + 80 mg (20 mg/mL)
993780|NCT00831129|B3|Baseline|Total|Total of all reporting groups
993781|NCT00831129|B2|Baseline|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993782|NCT00831129|B1|Baseline|Placebo|simvastatin 40 mg/day plus placebo
993783|NCT00831129|P2|Participant Flow|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993784|NCT00831129|P1|Participant Flow|Placebo|simvastatin 40 mg/day plus placebo
993785|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993786|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993787|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993788|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993789|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993790|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993791|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993792|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993801|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993802|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993803|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993804|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993805|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993806|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993807|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993808|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993809|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993810|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993811|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993812|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993813|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993814|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993815|NCT00831129|O2|Outcome|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993816|NCT00831129|O1|Outcome|Placebo|simvastatin 40 mg/day plus placebo
993817|NCT00831129|E2|Reported Event|Rosiglitazone|simvastatin 40 mg/day plus rosiglitazone 4 mg/day
993818|NCT00831129|E1|Reported Event|Placebo|simvastatin 40 mg/day plus placebo
993819|NCT00830960|B7|Baseline|Total|Total of all reporting groups
993820|NCT00830960|B6|Baseline|Clopidogrel 300/75 Low Weight/Elderly|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993821|NCT00830960|B5|Baseline|Prasugrel 30/5 Low Weight/Elderly|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993822|NCT00830960|B4|Baseline|Clopidogrel 300/75 Primary|Study treatment of clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993823|NCT00830960|B3|Baseline|Prasugrel 30/5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993824|NCT00830960|B2|Baseline|Prasugrel 30/7.5 Primary|Study treatment of prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993825|NCT00830960|B1|Baseline|Prasugrel 60/10 Primary|"Study treatment of prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)~Reporting groups for Baseline Characteristics do not include all randomized participants (n=720), but includes all randomized participants who received at least 1 dose of study drug."
993826|NCT00830960|P6|Participant Flow|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993827|NCT00830960|P5|Participant Flow|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993828|NCT00830960|P4|Participant Flow|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993829|NCT00830960|P3|Participant Flow|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993830|NCT00830960|P2|Participant Flow|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993831|NCT00830960|P1|Participant Flow|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993832|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993833|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993834|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993835|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993836|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993837|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993838|NCT00830960|O4|Outcome|Clopidogrel 300/75 PD|Population includes participants in genetics substudy who were randomly assigned to receive a clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
993839|NCT00830960|O3|Outcome|Prasugrel 30/5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
993840|NCT00830960|O2|Outcome|Prasugrel 30/7.5 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the Primary and Low Weight/Elderly Cohorts combined.
993841|NCT00830960|O1|Outcome|Prasugrel 60/10 PD|Population includes participants in genetics substudy who were randomly assigned to receive a prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Primary Cohort.
993842|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993843|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993844|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993845|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993846|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993847|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993848|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993849|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993850|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993851|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993852|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993853|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993854|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993855|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993856|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993857|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993858|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993859|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993860|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993861|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993862|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993863|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993864|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993865|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993866|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993867|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993868|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993968|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993869|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993870|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993871|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993872|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993873|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993874|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993875|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993876|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993877|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993878|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993879|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993880|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993881|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993882|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993883|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993884|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993885|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993886|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993887|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993888|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993889|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993890|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993891|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993892|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993893|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993894|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993895|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993896|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993969|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993897|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993898|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993899|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993900|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993901|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993902|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants in primary cohort randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort participant weight ≥60 kg and age <75 years)
993903|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993904|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993905|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993906|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993907|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993908|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993909|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993910|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993911|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993912|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993913|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the low weight/elderly cohort (participant weight <60 kg or age ≥75 years)
993914|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by clopidogrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993915|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993916|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993917|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg LD followed by prasugrel 10-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993918|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a clopidogrel 300-mg LD.
993919|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were treated with a prasugrel 30-mg LD.
993920|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were treated with a clopidogrel 300-mg LD.
993921|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 30-mg LD(including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
993922|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort who were treated with a prasugrel 60-mg LD.
993923|NCT00830960|O6|Outcome|Clopidogrel 300/75 Low Weight/Elderly|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993924|NCT00830960|O5|Outcome|Prasugrel 30/5 Low Weight/Elderly|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the Low Weight/Elderly cohort (participant weight <60 kg or age ≥75 years)
993925|NCT00830960|O4|Outcome|Clopidogrel 300/75 Primary|Population includes participants randomly assigned to receive clopidogrel 300-mg LD followed by prasugrel 75-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993970|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993926|NCT00830960|O3|Outcome|Prasugrel 30/5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993927|NCT00830960|O2|Outcome|Prasugrel 30/7.5 Primary|Population includes participants randomly assigned to receive prasugrel 30-mg LD followed by prasugrel 7.5-mg MD daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993928|NCT00830960|O1|Outcome|Prasugrel 60/10 Primary|Population includes participants randomly assigned to receive prasugrel 60-mg loading dose (LD) followed by prasugrel 10-mg maintenance dose (MD) daily in the primary cohort (participant weight ≥60 kg and age <75 years)
993929|NCT00830960|O5|Outcome|Clopidogrel 300-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who randomly assigned to receive a clopidogrel 300-mg LD.
993930|NCT00830960|O4|Outcome|Prasugrel 30-mg LD Low Weight/Elderly|Population includes participants in low weight/elderly cohort who were randomly assigned to receive a prasugrel 30-mg LD.
993931|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
993932|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
993933|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
993934|NCT00830960|O3|Outcome|Clopidogrel 300-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a clopidogrel 300-mg LD.
993935|NCT00830960|O2|Outcome|Prasugrel 30-mg LD Primary|Population includes participants in primary cohort who were randomly assigned to receive a prasugrel 30-mg LD (including participants in both Prasugrel 30/7.5 Primary and Prasugrel 30/5 Primary populations).
993936|NCT00830960|O1|Outcome|Prasugrel 60-mg LD Primary|Population includes participants in primary cohort randomly assigned to receive prasugrel 60-mg LD
993937|NCT00830960|E7|Reported Event|Clopidogrel 300/75 No Weight|Participant didn't have weight recorded. Loading dose 300 mg followed by maintenance dose 75 mg/day
993938|NCT00830960|E6|Reported Event|Clopidogrel 300/75 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
993939|NCT00830960|E5|Reported Event|Prasugrel 30/5 Low Weight/Elderly|Low Weight/Elderly = participant weight <60 kg or age ≥75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
993940|NCT00830960|E4|Reported Event|Clopidogrel 300/75 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 300 mg followed by maintenance dose 75 mg/day
993941|NCT00830960|E3|Reported Event|Prasugrel 30/5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30 mg followed by maintenance dose 5 mg/day.
993942|NCT00830960|E2|Reported Event|Prasugrel 30/7.5 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 30mg followed by maintenance dose 7.5 mg/day
993943|NCT00830960|E1|Reported Event|Prasugrel 60/10 Primary|Primary = participant weight ≥60 kg and age <75 years. Loading dose 60 mg followed by maintenance dose 10 mg/day.
993944|NCT00830947|B3|Baseline|Total|Total of all reporting groups
993945|NCT00830947|B2|Baseline|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
993946|NCT00830947|B1|Baseline|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
993947|NCT00830947|P2|Participant Flow|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
993948|NCT00830947|P1|Participant Flow|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
993949|NCT00830947|O2|Outcome|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
993950|NCT00830947|O1|Outcome|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
993951|NCT00830947|E2|Reported Event|Sham (Inactive Device)|Sham Device : Inactive sham device that is held in the mouth for 20 minutes.
993952|NCT00830947|E1|Reported Event|OrthoAccel Device|OrthoAccel Device : The OA device provides a light vibration at 0.2 Newtons and 30 Hz. frequency for 20 minutes daily.
993953|NCT00830804|B1|Baseline|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993954|NCT00830804|P1|Participant Flow|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993955|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993956|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993957|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993958|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993959|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993960|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993961|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993962|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993963|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993964|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993965|NCT00830804|O1|Outcome|RAL + DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993966|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993967|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
997001|NCT00822900|B1|Baseline|Progesterone|
993971|NCT00830804|O1|Outcome|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993972|NCT00830804|E1|Reported Event|RAL+DRV/RTV|Raltegravir (400 mg BID) plus Darunavir/Ritonavir (800 mg/100 mg QD) for 52 weeks
993974|NCT00830791|B6|Baseline|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
993975|NCT00830791|B5|Baseline|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
993976|NCT00830791|B4|Baseline|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
993977|NCT00830791|B3|Baseline|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
993978|NCT00830791|B2|Baseline|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
993979|NCT00830791|B1|Baseline|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
993980|NCT00830791|P6|Participant Flow|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without severe renal insufficiency who received MK-941 at a dose of 5 mg administered as a single oral dose.
993981|NCT00830791|P5|Participant Flow|MK-0941 5 mg Severe Renal Insufficiency|MK-0941 administered as a single oral dose of 5 mg to participants with severe renal insufficiency.
993982|NCT00830791|P4|Participant Flow|Control + 20 mg MK-0941|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) but without moderate renal insufficiency who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
993983|NCT00830791|P3|Participant Flow|MK-0941 20 mg Moderate Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with moderate renal insufficiency.
993984|NCT00830791|P2|Participant Flow|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus but without mild renal insufficiency (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
993985|NCT00830791|P1|Participant Flow|MK-0941 20 mg Mild Renal Insufficiency|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2) to participants with mild renal insufficiency.
993986|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg.
993987|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
993988|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
993989|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
993990|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg (10 mg x 2).
993991|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
993992|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
993993|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
993994|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
993995|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
993996|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose (10 mg x 2).
993997|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
993998|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose of 10 mg x 2.
993999|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
994000|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994001|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994002|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994003|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994004|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
994005|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
994045|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
997002|NCT00822900|P2|Participant Flow|Placebo|
994006|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994007|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994008|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994009|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994010|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
994011|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
994012|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994013|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994014|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994015|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994016|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
994017|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
994018|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994019|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994020|NCT00830791|O2|Outcome|Control + MK-0941 5 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 5 mg administered as a single oral dose.
994021|NCT00830791|O1|Outcome|MK-0941 5 mg|MK-0941 administered as a single oral dose of 5 mg.
994022|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994023|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994024|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994025|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994026|NCT00830791|O2|Outcome|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994027|NCT00830791|O1|Outcome|MK-0941 20 mg|MK-0941 administered as a single oral dose of 20 mg (10 mg x 2).
994028|NCT00830791|E3|Reported Event|MK-0941 20 mg and Moderate Renal Insufficiency|MK-0941 was administered as a single oral dose of 20 mg to participants with moderate renal insufficiency.
994029|NCT00830791|E2|Reported Event|MK-0941 20 mg and Mild Renal Insufficiency|MK-0941 was administered as a single oral dose to participants with mild renal insufficiency.
994030|NCT00830791|E1|Reported Event|Control + MK-0941 20 mg|Age, gender-, race-, body mass index (BMI) and hemoglobin A1C (HbA1C) matched controls with Type 2 Diabetes Mellitus (T2DM) who received MK-941 at a dose of 20 mg administered as a single oral dose of 10 mg x 2.
994031|NCT00830765|B3|Baseline|Total|Total of all reporting groups
994032|NCT00830765|B2|Baseline|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
994033|NCT00830765|B1|Baseline|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
994034|NCT00830765|P2|Participant Flow|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
994035|NCT00830765|P1|Participant Flow|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
994036|NCT00830765|O2|Outcome|Placebo Group|Progesterone injection was compared to placebo injection on a weekly basis.
994037|NCT00830765|O1|Outcome|Progesterone Group|Progesterone injection was compared to placebo injection on a weekly basis.
994038|NCT00830765|E2|Reported Event|2 Progesterone|The participant will receive weekly injections of 100mg of OHP17 from the time of enrollment until 34 weeks' gestation or delivery, whichever occurs first.
994039|NCT00830765|E1|Reported Event|1 Placebo|The participant will receive a weekly injection of placebo from the time of enrollment up until 34 weeks' gestation or delivery, whichever occurs first.
994040|NCT00830440|B3|Baseline|Total|Total of all reporting groups
994041|NCT00830440|B2|Baseline|Control: (Diet and Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
994042|NCT00830440|B1|Baseline|EndoBarrier and Diet/Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
994043|NCT00830440|P2|Participant Flow|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
994044|NCT00830440|P1|Participant Flow|EndoBarrier Device|"EndoBarrier + Diet + Lifestyle counseling 12 Week implant duration~EndoBarrier: Monthly visits"
994046|NCT00830440|O1|Outcome|EndoBarrier/Diet and Lifestyle Counseling/12 Weeks|12 week implantation period
994047|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
994048|NCT00830440|O1|Outcome|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
994049|NCT00830440|O2|Outcome|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
994050|NCT00830440|O1|Outcome|EndoBarrier/Diet and Lifestyle Counseling/12 Weeks|12 week implantation period
994051|NCT00830440|E2|Reported Event|Control (Diet & Lifestyle Counseling)|"Diet + Lifestyle counseling~Diet + Lifestyle Counseling: Monthly Visits"
994052|NCT00830440|E1|Reported Event|EndoBarrier and Diet and Lifestyle Counseling|"EndoBarrier + Diet + Lifestyle counseling~EndoBarrier: Monthly visits"
994053|NCT00830388|B1|Baseline|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
994054|NCT00830388|P1|Participant Flow|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
994055|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
994056|NCT00830388|O1|Outcome|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
994057|NCT00830388|E1|Reported Event|Ketoconazole 2% Foam|Open-label study using Ketoconazole 2% foam applied twice daily to all affected areas for 2 weeks.
994058|NCT00830375|B1|Baseline|Memantine|10-30mg tablets of memantine taken once daily by mouth
994059|NCT00830375|P1|Participant Flow|Memantine|10-30mg tablets of memantine taken once daily by mouth
994060|NCT00830375|O1|Outcome|Memantine|10-30mg tablets of memantine taken once daily by mouth
994061|NCT00830375|E1|Reported Event|Memantine|10-30mg tablets of memantine taken once daily by mouth
994062|NCT00830362|B3|Baseline|Total|Total of all reporting groups
994063|NCT00830362|B2|Baseline|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
994064|NCT00830362|B1|Baseline|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
994065|NCT00830362|P2|Participant Flow|Placebo|Placebo : administered once. The subjects whose data we analyzed upon study completion who received placebo were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
994066|NCT00830362|P1|Participant Flow|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects whose data we analyzed upon study completion who received propranolol were those that received the medication and completed BOTH the test and retrieval sessions (Session 1 and 2). Our N=50 that we report in the protocol section the total number of participants (from both the propranolol and placebo groups) that were analyzed.
994067|NCT00830362|O2|Outcome|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
994068|NCT00830362|O1|Outcome|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
994069|NCT00830362|E2|Reported Event|Placebo|Placebo : administered once. The subjects analyzed who received placebo were those that received the sugar pill and completed both the test and retrieval sessions (Test Day 1 and 2).
994070|NCT00830362|E1|Reported Event|Propranolol 40mg|Propranolol : 40 mg administered once. The subjects analyzed who received propranolol were those that received the medication and completed both the test and retrieval sessions (Test Day 1 and 2).
994071|NCT00830336|B3|Baseline|Total|Total of all reporting groups
994072|NCT00830336|B2|Baseline|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
994073|NCT00830336|B1|Baseline|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
994074|NCT00830336|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in second period
994075|NCT00830336|P1|Participant Flow|Azithromycin (Test) First|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
994076|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
994077|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
994078|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
994079|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
994080|NCT00830336|O2|Outcome|Zithromax®|Zithromax® for Oral Suspension 200 mg/5 mL (reference) dosed in either period
994081|NCT00830336|O1|Outcome|Azithromycin|Azithromycin for Oral Suspension 200 mg/5 mL (test) dosed in either period
994082|NCT00830310|B1|Baseline|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994117|NCT00830232|E2|Reported Event|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
994118|NCT00830232|E1|Reported Event|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
994083|NCT00830310|P1|Participant Flow|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994084|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994085|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994086|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994087|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994088|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994089|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994090|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994091|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994181|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994092|NCT00830310|O1|Outcome|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994093|NCT00830310|E1|Reported Event|Customized Adherence Enhancement (CAE)|"Participants will be assigned to receive one or more of the study interventions based upon the participant's responses on the AMSQ and reasons for non-adherence on the ROMI.~Individuals will participate in a series of 4 60-minute sessions over a 4-week period, with the study therapist who will implement the module-based intervention. The number of modules may differ depending on the baseline adherence profile of the participant.~An intervention manual developed by the investigators will provide explicit guidelines regarding how modules may be co-administered in single or multiple sessions to minimize redundancy as well as time and effort burden on study participants. The manual for each module will specifically address how any module could be combined with the other modules."
994094|NCT00830284|B1|Baseline|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
994095|NCT00830284|P1|Participant Flow|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
994096|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
994097|NCT00830284|O1|Outcome|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
994098|NCT00830284|E1|Reported Event|Recruitment|"Patients with hypoxic respiratory failure~Recruitment maneuver: Three types of maneuvers will be performed.~6cc/kg tidal volumes at an appropiate rate on current prescribed PEEP level.~6cc/Kg tidal volumes at an appropiate rate following a 40 cmH2O for 40 seconds maneuver returning to a pflex plus 2 cmH2O PEEP level.~PEEP titration starting a 15 cmH2O and increasing in 5 cmH2O increases until the PaO2+PaCO2 is 400 or higher."
994099|NCT00830258|B3|Baseline|Total|Total of all reporting groups
994100|NCT00830258|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
994101|NCT00830258|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
994102|NCT00830258|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
994103|NCT00830258|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
994104|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
994105|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
994106|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
994107|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
994108|NCT00830258|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
994109|NCT00830258|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
994110|NCT00830232|B3|Baseline|Total|Total of all reporting groups
994111|NCT00830232|B2|Baseline|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
994112|NCT00830232|B1|Baseline|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
994113|NCT00830232|P2|Participant Flow|Open-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using open stent cell stents. This type of stent is a tube shaped graft composed of flexible nitinol rings. The device used in this group was the Acculinx open-cell stent.~Stenting procedure eas performed on standard fashion.Filters were used as embolic protection device."
994114|NCT00830232|P1|Participant Flow|Closed-cell Stent|"Patients enrolled in this study arm underwent for carotid stenting using closed stent cell. The graft used in this group was the Xact closed-cell stent. This type of device is a rigid device with a dense composition between the nitinol rings.~Carotid stenting was used on standard fashion using filters as embolic protection device."
994115|NCT00830232|O2|Outcome|Open-cell Stent|Open-cell stent : Open-cell Stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
994116|NCT00830232|O1|Outcome|Closed-cell Stent|closed-cell stent : Closed-cell stent: Comparison of two types of carotid stent designs (open- vs. closed-cell) regarding the primary and secondary outcomes.
994209|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
997003|NCT00822900|P1|Participant Flow|Progesterone|
994120|NCT00830219|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
994121|NCT00830219|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
994122|NCT00830219|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
994123|NCT00830219|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
994124|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
994125|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
994126|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
994127|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
994128|NCT00830219|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
994129|NCT00830219|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
994130|NCT00830206|B3|Baseline|Total|Total of all reporting groups
994131|NCT00830206|B2|Baseline|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
994132|NCT00830206|B1|Baseline|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
994133|NCT00830206|P2|Participant Flow|Zithromax® (Reference) First|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in first period followed by Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in second period
994134|NCT00830206|P1|Participant Flow|Azithromycin (Test) First|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in first period followed by Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in second period
994135|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
994136|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
994137|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
994138|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
994139|NCT00830206|O2|Outcome|Zithromax®|Zithromax® Oral Suspension 200 mg/5 mL (reference) dosed in either period
994140|NCT00830206|O1|Outcome|Azithromycin|Azithromycin Oral Suspension 200 mg/5 mL (test) dosed in either period
994141|NCT00830167|B3|Baseline|Total|Total of all reporting groups
994142|NCT00830167|B2|Baseline|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994143|NCT00830167|B1|Baseline|Placebo|Placebo was administered twice a day for 15 weeks.
994144|NCT00830167|P2|Participant Flow|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994145|NCT00830167|P1|Participant Flow|Placebo|Placebo was administered twice a day for 15 weeks.
994146|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994147|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994148|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994149|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994150|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994151|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994152|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994153|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994233|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994154|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994155|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994156|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994157|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994158|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994159|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994160|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994161|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994162|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994163|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994164|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994165|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994166|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994167|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994168|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994169|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994170|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994171|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994172|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994173|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994174|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994175|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994176|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994177|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994178|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994179|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994180|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
997004|NCT00822900|O2|Outcome|Placebo|
994182|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994183|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994184|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994185|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994186|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994187|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994188|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994189|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994190|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994191|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994192|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994193|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994194|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994195|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994196|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994197|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994198|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994199|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994200|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994201|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994202|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994203|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994204|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994205|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994206|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994207|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994208|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
997005|NCT00822900|O1|Outcome|Progesterone|
994210|NCT00830167|O2|Outcome|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994211|NCT00830167|O1|Outcome|Placebo|Placebo was administered twice a day for 15 weeks.
994212|NCT00830167|E2|Reported Event|Pregabalin|Pregabalin was administered twice a day at the starting dose of 150 mg/day in the first week and escalated to 300 mg/day at the end of Week 1. Pregabalin dose was titrated to 450 mg/day at the end of Week 2 based on the participant’s individual response and tolerability to pregabalin. Treatment period was 15 weeks that consisted of 3-week dose optimization phase and 12-week fixed dose phase.
994213|NCT00830167|E1|Reported Event|Placebo|Placebo was administered twice a day for 15 weeks.
994214|NCT00830128|B1|Baseline|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994215|NCT00830128|P1|Participant Flow|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994216|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994217|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994218|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994219|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994220|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994221|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994222|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994223|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994224|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994225|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994226|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994227|NCT00830128|O1|Outcome|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994228|NCT00830128|E1|Reported Event|Pregabalin|Pregabalin treatment was started at 150 mg/day in Week 0 and escalated to 300 mg/day at Week 1. After that, participants could receive a maximum dose of 450 mg/day (225 mg, twice daily) for 52 weeks. During the term of the study, the dosage was to be adjusted (dose escalation/decrease), taking safety and efficacy with respect to pain into account.
994229|NCT00830115|B1|Baseline|Pantoprazole|All patients enrolled
994230|NCT00830115|P1|Participant Flow|Pantoprazole|All patients enrolled
994231|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994232|NCT00830115|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994234|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994235|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994236|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
994237|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
994238|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
994239|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
994240|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
994241|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994242|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
994243|NCT00830115|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
994244|NCT00830115|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994245|NCT00830076|B1|Baseline|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
994246|NCT00830076|P1|Participant Flow|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
994247|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
994248|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
994249|NCT00830076|O1|Outcome|All Participants|Participants received four 2-day treatment regimens (sitagliptin + placebo metformin for 2 days, metformin + placebo sitagliptin for 2 days, co-administration of sitagliptin + metformin for 2 days, and placebo sitagliptin + placebo metformin for 2 days) with a 7-day washout between each treatment period.
994250|NCT00830076|E4|Reported Event|Placebo Sitagliptin + Placebo Metformin|Participants received placebo sitagliptin + placebo metformin for 2 days.
994251|NCT00830076|E3|Reported Event|Sitagliptin + Metformin|Participants received co-administration of sitagliptin + metformin for 2 days.
994252|NCT00830076|E2|Reported Event|Metformin + Placebo Sitagliptin|Participants received metformin + placebo sitagliptin for 2 days.
994253|NCT00830076|E1|Reported Event|Sitagliptin + Placebo Metformin|Participants received sitagliptin + placebo metformin for 2 days.
994254|NCT00830037|B3|Baseline|Total|Total of all reporting groups
994255|NCT00830037|B2|Baseline|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
994256|NCT00830037|B1|Baseline|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
994257|NCT00830037|P2|Participant Flow|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
994258|NCT00830037|P1|Participant Flow|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
994259|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
994260|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
994261|NCT00830037|O2|Outcome|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
994262|NCT00830037|O1|Outcome|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
994263|NCT00830037|E2|Reported Event|Oral Iron|Ferrous Sulfate: Oral ferrous sulfate 325mg three times daily over 8 weeks. Further cycles of oral iron may be used based on periodic monitoring of iron stores.
994264|NCT00830037|E1|Reported Event|IV Iron|IV Iron: IV iron sucrose 200 mg over 2 hours baseline visit, week 2, week 4, week 6 and week 8 for a total of 1000mg total dose. Further cycles of iv iron may be used based on periodic monitoring of iron stores.
994265|NCT00830024|B3|Baseline|Total|Total of all reporting groups
994266|NCT00830024|B2|Baseline|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
994267|NCT00830024|B1|Baseline|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
994268|NCT00830024|P2|Participant Flow|Reference First|Xanax XR® Tablet 3 mg reference product dosed in first period followed by Alprazolam Extended Release Tablet 3 mg test product dosed in second period
994269|NCT00830024|P1|Participant Flow|Test First|Alprazolam Extended Release Tablet 3 mg test product dosed in first period followed by Xanax XR® Tablet 3 mg reference product dosed in second period
994270|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
994271|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
994272|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
994273|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
994274|NCT00830024|O2|Outcome|Xanax XR®|Xanax XR® Tablet 3 mg reference product dosed in either period
994275|NCT00830024|O1|Outcome|Alprazolam|Alprazolam Extended Release Tablet 3 mg test product dosed in either period
994276|NCT00829998|B3|Baseline|Total|Total of all reporting groups
1033875|NCT00733993|O2|Outcome|Caffeine 150 Mg|150 MG of Caffeine
994277|NCT00829998|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
994278|NCT00829998|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
994279|NCT00829998|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
994280|NCT00829998|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
994281|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
994282|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
994283|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
994284|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
994285|NCT00829998|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
994286|NCT00829998|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
994287|NCT00829985|B3|Baseline|Total|Total of all reporting groups
994288|NCT00829985|B2|Baseline|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994289|NCT00829985|B1|Baseline|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994290|NCT00829985|P2|Participant Flow|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994291|NCT00829985|P1|Participant Flow|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994292|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994293|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994294|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994295|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994296|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994297|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994335|NCT00829829|B1|Baseline|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
994298|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994299|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994300|NCT00829985|O2|Outcome|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994301|NCT00829985|O1|Outcome|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994302|NCT00829985|E2|Reported Event|Placebo|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered daily doses of placebo placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The placebo was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 weight per volume [w/v]) was achieved.
994303|NCT00829985|E1|Reported Event|Glycerinated German Cockroach Allergenic Extract|Participants with German cockroach allergy and mild to moderate asthma, rhinitis, or both self-administered concentrated (1:20 weight per volume [w/v]) daily doses of glycerinated German cockroach allergenic extract (50% glycerin) placed under the tongue (sublingually) to dissolve. The treatment course and study duration was 6 months. Note: The extract was also administered during the preliminary dosing visits, up to five escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
994304|NCT00829933|B5|Baseline|Total|Total of all reporting groups
994305|NCT00829933|B4|Baseline|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
994306|NCT00829933|B3|Baseline|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
994307|NCT00829933|B2|Baseline|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
994308|NCT00829933|B1|Baseline|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
994309|NCT00829933|P4|Participant Flow|Warfarin|"Warfarin potassium tablets:~Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose"
994310|NCT00829933|P3|Participant Flow|DU-176b High Dose 60mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
994311|NCT00829933|P2|Participant Flow|DU-176b Intermediate Dose 45mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
994312|NCT00829933|P1|Participant Flow|DU-176b Low Dose 30mg|"DU-176b tablets:~DU-176b tablets taken once daily for 12 weeks"
994313|NCT00829933|O4|Outcome|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
994314|NCT00829933|O3|Outcome|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
994315|NCT00829933|O2|Outcome|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
994316|NCT00829933|O1|Outcome|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
994317|NCT00829933|E4|Reported Event|Warfarin|Warfarin potassium tablets taken once daily for 12 weeks while adjusting dose
994318|NCT00829933|E3|Reported Event|DU-176b High Dose 60mg|DU-176b tablets taken once daily for 12 weeks
994319|NCT00829933|E2|Reported Event|DU-176b Intermediate Dose 45mg|DU-176b tablets taken once daily for 12 weeks
994320|NCT00829933|E1|Reported Event|DU-176b Low Dose 30mg|DU-176b tablets taken once daily for 12 weeks
994321|NCT00829868|B3|Baseline|Total|Total of all reporting groups
994322|NCT00829868|B2|Baseline|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
994323|NCT00829868|B1|Baseline|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
994324|NCT00829868|P2|Participant Flow|Sonata® (Reference) First|Sonata® 10 mg Capsule (reference) dosed in first period followed by Zaleplon 10 mg Capsule (test) dosed in second period
994325|NCT00829868|P1|Participant Flow|Zaleplon (Test) First|Zaleplon 10 mg Capsule (test) dosed in first period followed by Sonata® 10 mg Capsule (reference) dosed in second period
994326|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
994327|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
994328|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
994329|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
994330|NCT00829868|O2|Outcome|Sonata®|Sonata® 10 mg Capsule (reference) dosed in either period
994331|NCT00829868|O1|Outcome|Zaleplon|Zaleplon 10 mg Capsule (test) dosed in either period
994332|NCT00829829|B4|Baseline|Total|Total of all reporting groups
994333|NCT00829829|B3|Baseline|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994334|NCT00829829|B2|Baseline|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
997006|NCT00822900|O2|Outcome|Placebo|
994336|NCT00829829|P3|Participant Flow|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994530|NCT00829296|P2|Participant Flow|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
994337|NCT00829829|P2|Participant Flow|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994338|NCT00829829|P1|Participant Flow|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
994339|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994340|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994341|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
994342|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994343|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994344|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
994345|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994346|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994347|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
994348|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994349|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994350|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
994351|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994352|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994353|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
994354|NCT00829829|O3|Outcome|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994355|NCT00829829|O2|Outcome|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994356|NCT00829829|O1|Outcome|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
994357|NCT00829829|E3|Reported Event|Rilonacept 160 mg|Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
994358|NCT00829829|E2|Reported Event|Rilonacept 80 mg|Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
994359|NCT00829829|E1|Reported Event|Placebo|Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection qw from Week 1 to Week 15.
994360|NCT00829790|B3|Baseline|Total|Total of all reporting groups
994361|NCT00829790|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
994362|NCT00829790|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
994363|NCT00829790|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
994364|NCT00829790|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
994365|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
994366|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
994367|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
994368|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
994369|NCT00829790|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
994370|NCT00829790|O1|Outcome|Doxycycline Monohydrate|25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in either period.
994371|NCT00829764|B3|Baseline|Total|Total of all reporting groups
994372|NCT00829764|B2|Baseline|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
994373|NCT00829764|B1|Baseline|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
994374|NCT00829764|P2|Participant Flow|Vibramycin® Monohydrate First|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in first period followed by 25mg(5mL) Doxycycline Monohydrate Oral Suspension test product dosed in the second period.
994375|NCT00829764|P1|Participant Flow|Doxycycline Monohydrate First|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in first period followed by 25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in the second period.
994376|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
994377|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
994378|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
994379|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
994380|NCT00829764|O2|Outcome|Vibramycin® Monohydrate|25mg(5mL) Vibramycin® Monohydrate Oral Suspension reference product dosed in either period.
994381|NCT00829764|O1|Outcome|Doxycycline Monohydrate|25mg(5mL)Doxycycline Monohydrate Oral Suspension test product dosed in either period.
994382|NCT00829738|B1|Baseline|Pantoprazole|All patients enrolled
994383|NCT00829738|P1|Participant Flow|Pantoprazole|All patients enrolled
994384|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994385|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994386|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994387|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994388|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994389|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994390|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994391|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994392|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994393|NCT00829738|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994394|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994395|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994396|NCT00829738|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
994397|NCT00829738|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
994398|NCT00829712|B3|Baseline|Total|Total of all reporting groups
994399|NCT00829712|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
994400|NCT00829712|B1|Baseline|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
994401|NCT00829712|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride test product dosed in the second period.
994402|NCT00829712|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
994403|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
994404|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
994405|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
994406|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
994407|NCT00829712|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
994408|NCT00829712|O1|Outcome|Dexmethylphenidate HCl|10 mg Demethylphenidate Hydrochloride Tablets test product dosed in either period.
994409|NCT00829686|B3|Baseline|Total|Total of all reporting groups
994410|NCT00829686|B2|Baseline|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
994411|NCT00829686|B1|Baseline|No Intervention|No antibiotic
994412|NCT00829686|P2|Participant Flow|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
994413|NCT00829686|P1|Participant Flow|No Intervention|No antibiotic
994414|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
994415|NCT00829686|O1|Outcome|No Intervention|No antibiotic
994416|NCT00829686|O2|Outcome|Septra DS|Septra DS (800/160) two pills PO BID x 7 days
994417|NCT00829686|O1|Outcome|No Intervention|No antibiotic
994418|NCT00829673|B3|Baseline|Total|Total of all reporting groups
994419|NCT00829673|B2|Baseline|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
994420|NCT00829673|B1|Baseline|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
997007|NCT00822900|O1|Outcome|Progesterone|
994421|NCT00829673|P2|Participant Flow|Focalin® First|10 mg Focalin® Tablets reference product dosed in first period followed by 10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in the second period.
994422|NCT00829673|P1|Participant Flow|Dexmethylphenidate HCl First|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in first period followed by 10 mg Focalin® Tablets reference product dosed in the second period.
994423|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
994424|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
994425|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
994426|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
994427|NCT00829673|O2|Outcome|Focalin®|10 mg Focalin® Tablets reference product dosed in either period.
994428|NCT00829673|O1|Outcome|Dexmethylphenidate HCl|10 mg Dexmethylphenidate Hydrochloride Tablets test product dosed in either period.
994429|NCT00829621|B3|Baseline|Total|Total of all reporting groups
994430|NCT00829621|B2|Baseline|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
994431|NCT00829621|B1|Baseline|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
994432|NCT00829621|P2|Participant Flow|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
994433|NCT00829621|P1|Participant Flow|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
994434|NCT00829621|O2|Outcome|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
994435|NCT00829621|O1|Outcome|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
994436|NCT00829621|E2|Reported Event|125 mmHg|"IVAC suction 125 mmHg~125 mmHg: Incisional Vacuum Assisted Closure (IVAC) Device, set to 125 mmHg suction throughout the duration of the IVAC use."
994437|NCT00829621|E1|Reported Event|75 mmHg|"IVAC suction 75 mmHg~75 mmHg suction: Incisional Vacuum Assisted Closure (IVAC) Device, set to 75 mmHg suction throughout the duration of the IVAC use."
994438|NCT00829530|B3|Baseline|Total|Total of all reporting groups
994439|NCT00829530|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
994440|NCT00829530|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
994441|NCT00829530|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
994442|NCT00829530|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
994443|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994444|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994445|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994446|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994447|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994448|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994449|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994450|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994451|NCT00829530|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994452|NCT00829530|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994453|NCT00829504|B3|Baseline|Total|Total of all reporting groups
994454|NCT00829504|B2|Baseline|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
994455|NCT00829504|B1|Baseline|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
994456|NCT00829504|P2|Participant Flow|Reference (Requip®) First|0.25 mg Requip® Tablets reference product dosed in first period followed by 0.25 mg Ropinirole HCl Tablets test product dosed in the second period.
994457|NCT00829504|P1|Participant Flow|Test (Ropinirole HCl) First|0.25 mg Ropinirole HCl Tablets test product dosed in first period followed by 0.25 mg Requip® Tablets reference product dosed in the second period.
994458|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
994459|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
994460|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
994461|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
994462|NCT00829504|O2|Outcome|Reference (Requip®)|0.25 mg Requip® Tablets reference product dosed in either period.
994463|NCT00829504|O1|Outcome|Test (Ropinirole HCl)|0.25 mg Ropinirole HCl Tablets test product dosed in either period.
994464|NCT00829452|B3|Baseline|Total|Total of all reporting groups
994465|NCT00829452|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
994529|NCT00829296|B1|Baseline|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
994466|NCT00829452|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
994467|NCT00829452|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
994468|NCT00829452|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
994469|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994470|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994471|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994472|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994473|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994474|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994475|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994476|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994477|NCT00829452|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
994478|NCT00829452|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
994479|NCT00829439|B1|Baseline|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
994480|NCT00829439|P4|Participant Flow|Levodopa / Carbidopa 15 mg/kg/Day|Levodopa / Carbidopa 15 mg/kg/day in 3 divided doses
994481|NCT00829439|P3|Participant Flow|Levodopa / Carbidopa 10 mg/kg/Day|Levodopa 10 mg/kg/day in 3 divided doses
994482|NCT00829439|P2|Participant Flow|Levodopa / Carbidopa 5 mg/kg/Day|Levodopa 5 mg/kg/day in 3 divided doses
994483|NCT00829439|P1|Participant Flow|Levodopa/Carbidopa 2 mg/kg/Day|Levodopa at 2 mg/kg/day in 3 divided doses
994484|NCT00829439|O1|Outcome|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
994485|NCT00829439|E1|Reported Event|Levodopa/Carbidopa|"Other Names:~Sinemet L-dopa~Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day.~Levodopa/Carbidopa (4:1): Dosages are based on levodopa.~Each cohort of 3 subjects will be placed on an increasing dose of levodopa (2, 5, 10, and 15 mg/kg/day) for 1 week, provided subjects in the preceding cohort tolerated the lower dose.~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
994486|NCT00829426|B3|Baseline|Total|Total of all reporting groups
994487|NCT00829426|B2|Baseline|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
994488|NCT00829426|B1|Baseline|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
994489|NCT00829426|P2|Participant Flow|Xanax® (Reference) First|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
994490|NCT00829426|P1|Participant Flow|Alprazolam (Test) First|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
994491|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
994492|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
994493|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
994494|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
994495|NCT00829426|O2|Outcome|Xanax®|Xanax XR® 3 mg Tablet (reference) dosed in first period followed by Alprazolam 3 mg Tablet (test) dosed in second period
994496|NCT00829426|O1|Outcome|Alprazolam|Alprazolam 3 mg ER Tablet (test) dosed in first period followed by Xanax XR® 3 mg Tablet (reference) dosed in second period
994497|NCT00829387|B3|Baseline|Total|Total of all reporting groups
994498|NCT00829387|B2|Baseline|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994499|NCT00829387|B1|Baseline|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994929|NCT00828568|B2|Baseline|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
994531|NCT00829296|P1|Participant Flow|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
994500|NCT00829387|P2|Participant Flow|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994501|NCT00829387|P1|Participant Flow|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994502|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994503|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994504|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994505|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994506|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994507|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994508|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994509|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994510|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994511|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994512|NCT00829387|O2|Outcome|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994513|NCT00829387|O1|Outcome|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994514|NCT00829387|E2|Reported Event|Educational|"Diabetes Education - Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator~Diabetic Education plus standard pharmaceutical care (ED/SC): Ten individual sessions of diabetes educations delivered by a doctoral level psychologist under the supervision of a certified diabetes educator."
994515|NCT00829387|E1|Reported Event|Behavioral|"Cognitive behavioral therapy - Ten sessions of individual treatment delivered by a doctoral level psychologist.~CBT plus standard pharmaceutical care (CBT/SC): Ten sessions of individual treatment delivered by a doctoral level psychologist."
994516|NCT00829309|B3|Baseline|Total|Total of all reporting groups
994517|NCT00829309|B2|Baseline|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
994518|NCT00829309|B1|Baseline|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
994519|NCT00829309|P2|Participant Flow|Pravachol® (Reference) First|Pravachol® 80 mg Tablet (reference) dosed in first period followed by Pravastatin 80 mg Tablet (test) dosed in second period
994520|NCT00829309|P1|Participant Flow|Pravastatin (Test) First|Pravastatin 80 mg Tablet (test) dosed in first period followed by Pravachol® 80 mg Tablet (reference) dosed in second period
994521|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
994522|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
994523|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
994524|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
994525|NCT00829309|O2|Outcome|Pravachol®|Pravachol® 80 mg Tablet (reference) dosed in either period
994526|NCT00829309|O1|Outcome|Pravastatin|Pravastatin 80 mg Tablet (test) dosed in either period
994527|NCT00829296|B3|Baseline|Total|Total of all reporting groups
994528|NCT00829296|B2|Baseline|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
994532|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
994533|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
994534|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
994535|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
994536|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
994537|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
994538|NCT00829296|O2|Outcome|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
994539|NCT00829296|O1|Outcome|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
994540|NCT00829296|E2|Reported Event|Metoprolol|"Starting at 50 mg daily dose is titrated to max 200 mg until target BP of 130/80 is reached~Metoprolol"
994541|NCT00829296|E1|Reported Event|Nebivolol|"Starting at dose of 5 mg daily titrated up to max of 40 mg until target BP of 130/80 is reached~nebivolol"
994542|NCT00829283|B3|Baseline|Total|Total of all reporting groups
994543|NCT00829283|B2|Baseline|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
994544|NCT00829283|B1|Baseline|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
994545|NCT00829283|P2|Participant Flow|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
994546|NCT00829283|P1|Participant Flow|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
994547|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
994548|NCT00829283|O1|Outcome|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
994549|NCT00829283|O2|Outcome|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
994550|NCT00829283|O1|Outcome|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
994551|NCT00829283|E2|Reported Event|Stepped-care|"Stepped-care~Behavioral Weight Loss: weekly individual sessions for 6 months~Behavioral Weight Loss + Guided self-help Cognitive-behavioral Therapy: weekly BWL sessions for 4 weeks and 6-8 CBT sessions for 5 months~Placebo: One pill daily~Sibutramine/Orlistat: Sibutramine 15 mg daily or Orlistat 120mg TID"
994552|NCT00829283|E1|Reported Event|Standard Care|"Standard Care~Behavioral Weight Loss: weekly individual sessions for 6 months"
994553|NCT00829244|B3|Baseline|Total|Total of all reporting groups
994554|NCT00829244|B2|Baseline|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
994555|NCT00829244|B1|Baseline|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994556|NCT00829244|P2|Participant Flow|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
994557|NCT00829244|P1|Participant Flow|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994558|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994559|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994560|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994561|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994562|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994563|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994564|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994565|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994566|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994567|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994568|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994569|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994570|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994571|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994572|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994573|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994574|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994575|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994576|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994577|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994578|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994579|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994580|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994581|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994930|NCT00828568|B1|Baseline|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
997008|NCT00822900|O2|Outcome|Placebo|
994582|NCT00829244|O2|Outcome|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant's ovarian response and according to the center's standard practice.
994583|NCT00829244|O1|Outcome|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994584|NCT00829244|E2|Reported Event|GONAL-f ® Standard Treatment|GONAL-f® (follitropin alfa) administered sc at a standard dose of 150 IU per day up to Day 5 of stimulation (S5) after which the dose was adjusted based upon the participant’s ovarian response and according to the center’s standard practice.
994585|NCT00829244|E1|Reported Event|GONAL-f ® CONSORT Calculator|GONAL-f® (follitropin alfa) administered subcutaneously (sc), dose ranging from 112.5 to 450 International Unit (IU) per day based on participant baseline characteristics determined according to the consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment (CONSORT) calculator throughout stimulation cycle.
994586|NCT00829179|B1|Baseline|RhuMab-E25|
994587|NCT00829179|P1|Participant Flow|RhuMab-E25|"Subjects with mild asthma received three doses of study drug subcutaneous injections at one month intervals. Dosing range was 150mg-375mg which was based on baseline IGE and subject body weight.~Subjects with a baseline Ige above 30 and up to 100 with a body weight between 30 and 150kg would receive a study drug dose of 150 mg. Subjects with an IGE 100-200 and body weight 30 - 150 kg would receive a dose of 225 mg. And up to subjects with an IGE of 600-700 only body weight of 30 - 60 would be included with a dose of 375 mg."
994588|NCT00829179|O1|Outcome|RhuMab-E25|
994589|NCT00829179|E1|Reported Event|RhuMab-E25|
994590|NCT00829166|B3|Baseline|Total|Total of all reporting groups
994591|NCT00829166|B2|Baseline|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994592|NCT00829166|B1|Baseline|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994593|NCT00829166|P2|Participant Flow|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 milligrams per square meter (mg/m^2) orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994594|NCT00829166|P1|Participant Flow|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenous (IV) infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
994595|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994596|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994597|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994598|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994599|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994600|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994601|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994602|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994931|NCT00828568|P3|Participant Flow|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
994932|NCT00828568|P2|Participant Flow|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
994946|NCT00828542|B2|Baseline|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of DMPA (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
994603|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994604|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994605|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994606|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994607|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994608|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994609|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994610|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994611|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994612|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994613|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994614|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994615|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994616|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994617|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994618|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994619|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994620|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994933|NCT00828568|P1|Participant Flow|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
997009|NCT00822900|O1|Outcome|Progesterone|
994621|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994622|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994623|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994624|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994625|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994626|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994627|NCT00829166|O2|Outcome|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994628|NCT00829166|O1|Outcome|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994629|NCT00829166|E3|Reported Event|Lapatinib + Capecitabine/ Trastuzumab Emtansine|"Participants of Lapatinib + Capecitabine arm were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis."
994630|NCT00829166|E2|Reported Event|Lapatinib + Capecitabine|Participants received lapatinib 1250 mg (five 250 mg tablets) orally once daily during each 21-day cycle + capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination. Participants of this group were allowed to cross over to receive trastuzumab emtansine based on statistically significant OS benefit in favor of trastuzumab emtansine demonstrated in second interim analysis.
994631|NCT00829166|E1|Reported Event|Trastuzumab Emtansine|Participants received trastuzumab emtansine 3.6 mg/kg IV infusion over 30-90 minutes on Day 1 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
994632|NCT00829049|B3|Baseline|Total|Total of all reporting groups
994633|NCT00829049|B2|Baseline|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
994634|NCT00829049|B1|Baseline|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
994635|NCT00829049|P2|Participant Flow|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
994636|NCT00829049|P1|Participant Flow|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
994637|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
994638|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
994639|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
994640|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
994641|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
994642|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
994643|NCT00829049|O2|Outcome|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
994644|NCT00829049|O1|Outcome|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
994645|NCT00829049|E2|Reported Event|Adapalene Gel 0.3%|1 pea-size amount, QD x 16 weeks
994646|NCT00829049|E1|Reported Event|Tazarotene Cream 0.1%|1 pea-size amount, QD x 16 weeks
994647|NCT00829036|B1|Baseline|Baseline Wayfinding Performance|An Orientation and Mobility specialist teaches subjects (1) how to find each of 4 specific locations in an open space from a random starting location, and (2) how to navigate hallways from a known starting location to find each of 8 specific locations in the hallways of the Atlanta VA Medical Center. Subjects are then (1) brought to a random start point in the open space and asked to walk to the same 4 specific locations they were taught to find and (2) brought to a known starting point in the hallways of the VA Medical Center and asked to walk to the same 8 specific locations they were taught to find.
994648|NCT00829036|P1|Participant Flow|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
994649|NCT00829036|O1|Outcome|Prototype vs. Baseline|"Prototype:~Subjects are trained for 20 minutes in the use of the prototype (1) in open spaces and (2) in hallways. They are taught how to select a destination, and obtain turn-by-turn navigation directions to walk to the selected destination. Subjects are then asked to walk to 12 different unknown locations, one location in each of 12 timed trials. Half of these locations are in open spaces and half in hallways. Walking time is the performance measure.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subject how to find (walk to) each of the same 12 locations, though in a different order. Again, 6 of these are in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations, one location per trial. Again, walking time is the performance measure."
994650|NCT00829036|E1|Reported Event|Wayfinding: Prototype vs. Baseline|"Prototype:~Subjects are trained to use the prototype to walk to selected destinations (1) in open spaces and (2) through hallways. Then, over 12 trials, subjects are asked to use the prototype to walk to a different unknown location in each trial. Half the locations are in open spaces and half in hallways. Performance time is measured.~Baseline:~An Orientation and Mobility (O&M) specialist first teaches the subjects how to find (walk to) 12 specific locations, 6 in open spaces and 6 in hallways. Then, over 12 trials, subjects are asked to independently walk to each of the specified locations. Performance time is measured."
994651|NCT00829010|B6|Baseline|Total|Total of all reporting groups
994652|NCT00829010|B5|Baseline|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994653|NCT00829010|B4|Baseline|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994654|NCT00829010|B3|Baseline|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994655|NCT00829010|B2|Baseline|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994656|NCT00829010|B1|Baseline|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994834|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994835|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994836|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994657|NCT00829010|P5|Participant Flow|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994658|NCT00829010|P4|Participant Flow|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994659|NCT00829010|P3|Participant Flow|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994660|NCT00829010|P2|Participant Flow|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994661|NCT00829010|P1|Participant Flow|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as study vaccine. The Synflorix™ vaccine was administered intramuscularly (IM) in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994662|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994663|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994837|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994838|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994664|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994665|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994666|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994667|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994668|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994669|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994670|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994839|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994934|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
994935|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
994671|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994672|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994673|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994674|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994675|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994676|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994677|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994840|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994841|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994678|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994679|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994680|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994681|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994682|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994683|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994684|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994842|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994936|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
994937|NCT00828568|O3|Outcome|Vehicle|Patients receiving imiquimod vehicle for 16 weeks
997010|NCT00822900|O2|Outcome|Placebo|
994685|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994686|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994687|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994688|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994689|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994690|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994691|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994843|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994844|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994692|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994693|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994694|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994695|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994696|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994697|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994698|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994845|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994938|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
994939|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
994699|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994700|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994701|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994702|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994703|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994704|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994705|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994846|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994847|NCT00828984|E3|Reported Event|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994706|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994707|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994708|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994709|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994710|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994711|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994712|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994848|NCT00828984|E2|Reported Event|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994940|NCT00828568|O2|Outcome|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
994941|NCT00828568|O1|Outcome|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
994713|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994714|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994715|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994716|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994717|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994718|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994719|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994849|NCT00828984|E1|Reported Event|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994850|NCT00828945|B1|Baseline|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
997011|NCT00822900|O1|Outcome|Progesterone|
994720|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994721|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994722|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994723|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994724|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994725|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994726|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994851|NCT00828945|P1|Participant Flow|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994852|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994942|NCT00828568|E3|Reported Event|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
997012|NCT00822900|O2|Outcome|Placebo|
994727|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994728|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994729|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994730|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994731|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994732|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994733|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994853|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994854|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994855|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994734|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994735|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994736|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994737|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994738|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994739|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994740|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994856|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994857|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994943|NCT00828568|E2|Reported Event|Aldara - Imiquimod 5%|Aldara, Imiquimod 5% applied for 16 weeks
994741|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994742|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994743|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994744|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994745|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994746|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994747|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994858|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994859|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994944|NCT00828568|E1|Reported Event|Imiquimod 5% Taro|Imiquimod 5% manufactured by Taro applied for 16 weeks
994748|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994749|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994750|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994751|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994752|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994753|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994754|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994860|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994861|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994862|NCT00828945|O1|Outcome|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994755|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994756|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994757|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994758|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994759|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994760|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994761|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994863|NCT00828945|E1|Reported Event|Statins|Participants with hyperlipidemia; high risk of developing cardiovascular disease and taking lipid lowering treatment (statins) were observed for 12 months.
994864|NCT00828841|B4|Baseline|Total|Total of all reporting groups
994945|NCT00828542|B3|Baseline|Total|Total of all reporting groups
995073|NCT00828139|B2|Baseline|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
994762|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994763|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994764|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994765|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994766|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994767|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994768|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994882|NCT00828750|B1|Baseline|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995061|NCT00828178|P1|Participant Flow|Fish Oil|fish oil 3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters) daily
994769|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994770|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994771|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994772|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994773|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994774|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994775|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994883|NCT00828750|P1|Participant Flow|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count (PC) at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995062|NCT00828178|O2|Outcome|Placebo|Corn Starch
994776|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994777|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994778|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994779|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994780|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994781|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994782|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994884|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995063|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
994783|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994784|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994785|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994786|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994787|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994788|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994789|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994885|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995064|NCT00828178|O2|Outcome|Placebo|Placebo (cornstarch)
995472|NCT00827073|E1|Reported Event|Tetracaine 0.5% Drop|"betadine: betadine 5%~Topical Anesthetic"
994790|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994791|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994792|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994793|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994794|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994795|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994796|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994886|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995065|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
994797|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994798|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994799|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994800|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994801|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994802|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994803|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994887|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995066|NCT00828178|O2|Outcome|Placebo|Corn starch
995067|NCT00828178|O1|Outcome|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
994804|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994805|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994806|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994807|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994808|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994809|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994810|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994888|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995068|NCT00828178|E2|Reported Event|Placebo|Placebo (cornstarch)
994811|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994812|NCT00829010|O5|Outcome|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994813|NCT00829010|O4|Outcome|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994814|NCT00829010|O3|Outcome|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994815|NCT00829010|O2|Outcome|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994816|NCT00829010|O1|Outcome|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994817|NCT00829010|E5|Reported Event|HIV- (2+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 2 primary doses (at 6 & 14 weeks of age at study Months 0 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994889|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
995069|NCT00828178|E1|Reported Event|Omega-3|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
994818|NCT00829010|E4|Reported Event|HIV- (3+0) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected.Subjects received 3 primary doses of Synflorix™ vaccine (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994819|NCT00829010|E3|Reported Event|HIV- (3+1) Group|Infants born from a HIV negative mother and confirmed as HIV unexposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994820|NCT00829010|E2|Reported Event|HIV+/- Group|Infants born from a HIV positive mother and confirmed as HIV exposed uninfected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered IM in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994821|NCT00829010|E1|Reported Event|HIV+/+ Group|Infants born from a HIV positive mother and confirmed as HIV infected. Subjects received 3 primary doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster dose of Synflorix™ vaccine (at 9 months of age, at study Month 8). Subjects in the group also received 3 primary vaccine doses (at 6, 10 & 14 weeks of age, at study Months 0, 1 and 2) and 1 booster vaccine dose (at 15-18 months of age, at study Month 14) of Tritanrix™-HepB/Hib, 2 vaccine doses of Rotarix™ (at 10 & 14 weeks of age, at study Months 1 and 2), and 2 doses of measles vaccine (9-10 months of age & 15-18 months of age, at study Months 8 and 14). Measles vaccine was not considered as a study vaccine. The Synflorix™ vaccine was administered intramuscularly in the right thigh, the Tritanrix™-HepB/Hib vaccine was administered IM in the left anterolateral thigh during the primary vaccination and in the left anterolateral thigh or left deltoid region during booster vaccination. Rotarix™ was given orally.
994822|NCT00828984|B4|Baseline|Total|Total of all reporting groups
994823|NCT00828984|B3|Baseline|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994824|NCT00828984|B2|Baseline|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994825|NCT00828984|B1|Baseline|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994826|NCT00828984|P3|Participant Flow|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994827|NCT00828984|P2|Participant Flow|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994828|NCT00828984|P1|Participant Flow|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994829|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994830|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994831|NCT00828984|O1|Outcome|Arm A (High-dose PEG 3350)|"Patients receive high-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~17g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994832|NCT00828984|O3|Outcome|Arm C (Placebo)|"Patients receive placebo PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~Placebo: Given PO~Laboratory Biomarker Analysis: Correlative studies"
994833|NCT00828984|O2|Outcome|Arm B (Low-dose Polyethylene Glycol)|"Patients receive low-dose macrogol 3350-based oral osmotic laxative PO QD. Treatment continues for up to 6 months in the absence of unacceptable toxicity.~8g day/macrogol 3350-based oral osmotic laxative: Given PO~Laboratory Biomarker Analysis: Correlative studies"
995070|NCT00828139|B5|Baseline|Total|Total of all reporting groups
997013|NCT00822900|O1|Outcome|Progesterone|
994865|NCT00828841|B3|Baseline|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994866|NCT00828841|B2|Baseline|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994867|NCT00828841|B1|Baseline|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994868|NCT00828841|P3|Participant Flow|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994869|NCT00828841|P2|Participant Flow|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994870|NCT00828841|P1|Participant Flow|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994871|NCT00828841|O2|Outcome|Non-squamous Cell Histology|Subjects who were identified as having non-squamous cell histology, prior to randomization to a treatment arm.
994872|NCT00828841|O1|Outcome|Squamous Cell Histology|Subjects who were identified as having squamous cell histology, prior to randomization to a treatment arm.
994873|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994890|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
996071|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
994874|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994875|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994876|NCT00828841|O3|Outcome|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994877|NCT00828841|O2|Outcome|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994878|NCT00828841|O1|Outcome|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994879|NCT00828841|E3|Reported Event|Platinum, Pemetrexed, Cetuximab (Arm C)|"Patients with squamous histology will receive pemetrexed and either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion. Patients with non-squamous histology are not eligible for this arm.~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994880|NCT00828841|E2|Reported Event|Platinum, Gemcitabine, Cetuximab (Arm B)|"Patients with squamous or non-squamous histologies will receive gemcitabine with either carboplatin or cisplatin for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion. The choice of platinum-based chemotherapy is also at the investigator's discretion.~Gemcitabine : Gemcitabine 1,000 mg/m2 Days 1 and 8 every 21 days~Cisplatin : Cisplatin 75 mg/m2 Day I every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
994881|NCT00828841|E1|Reported Event|Paclitaxel, Carboplatin, Cetuximab (Arm A)|"Patients with squamous or non-squamous histologies will receive carboplatin and paclitaxel for a minimum of four and a maximum of six 21-day cycles, plus cetuximab, and then enter a maintenance phase with single-agent cetuximab. Cetuximab will be given on Day 1, and weekly during chemotherapy, followed by biweekly administration during the maintenance period. The choice of delivering four, five or six cycles of chemotherapy is at the investigator's discretion.~Paclitaxel : Paclitaxel 200 mg/m2 Day 1 every 21 days~Carboplatin : Carboplatin AUC 6 Day 1 every 21 days~Cetuximab : Cetuximab will be administered at a loading dose of 400 mg/m2 on Day 1, Cycle 1 and at a dose of 250 mg/m2 weekly during chemotherapy. During the maintenance period, cetuximab will be dosed at 500 mg/m2 every two weeks."
997014|NCT00822900|O2|Outcome|Placebo|
994891|NCT00828750|O1|Outcome|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 milligrams (mg), 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
994892|NCT00828750|E1|Reported Event|Eltrombopag|Participants took eltrombopag orally once daily in the fasted state at an individualized dose of 12.5 mg, 25 mg, 37.5 mg, or 50 mg; the starting dose was the last dose in the prior eltrombopag study, TRA108109 (NCT00540423). Depending on the participant's platelet count at each visit, a dose modification guideline allowed participants to increase/reduce the dose or interrupt the eltrombopag treatment.
994893|NCT00828711|B4|Baseline|Total|Total of all reporting groups
994894|NCT00828711|B3|Baseline|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994895|NCT00828711|B2|Baseline|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994896|NCT00828711|B1|Baseline|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994897|NCT00828711|P3|Participant Flow|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994898|NCT00828711|P2|Participant Flow|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994899|NCT00828711|P1|Participant Flow|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994900|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994901|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994902|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994903|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994904|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994905|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994906|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994907|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994908|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994927|NCT00828568|B4|Baseline|Total|Total of all reporting groups
994928|NCT00828568|B3|Baseline|Vehicle|Patients receiving imiquimod Vehicle for 16 weeks
994909|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994910|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994911|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994912|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994913|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994914|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994915|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994916|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994917|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994918|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994919|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994920|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994921|NCT00828711|O3|Outcome|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994922|NCT00828711|O2|Outcome|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994923|NCT00828711|O1|Outcome|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994924|NCT00828711|E3|Reported Event|MVI 200|"MVI 200 mcg vaginal insert~Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994925|NCT00828711|E2|Reported Event|MVI 150|"MVI 150 mcg vaginal insert~Dose reservoir of 150 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 150 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994926|NCT00828711|E1|Reported Event|MVI 100|"MVI 100 mcg vaginal insert~Dose reservoir of 100 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 100 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request."
994947|NCT00828542|B1|Baseline|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
994948|NCT00828542|P2|Participant Flow|Depot Medroxyprogesterone Acetate|Women randomized to depot medroxyprogesterone acetate group had at the 6th week postpartum, 150 mg of depot medroxyprogesterone acetate intramuscular (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil). A new injection was applied every 90 days if the patient wished to keep using the method.
994949|NCT00828542|P1|Participant Flow|Etonogestrel Implant|Immediately after giving birth, women randomized to etonogestrel implant group had an Etonogestrel releasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24-48 h after delivery. It is a long-acting reversible contraceptive method, compounded by 68mg of etonogestrel, 3years of duration.
994950|NCT00828542|O2|Outcome|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolandia, Brazil)
994951|NCT00828542|O1|Outcome|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
994952|NCT00828542|E2|Reported Event|Depot Medroxyprogesterone|20 women received no contraceptives during the first 6 weeks after delivery, and at the 6th week, this group received IM 150 mg of depot medroxyprogesterone (Contracept®, EMS Sigma Pharma, Hortolândia, Brazil)
994953|NCT00828542|E1|Reported Event|Etonogestrel Implant|Twenty women were allocated to receive the ETGreleasing contraceptive implant (Implanon®, NV Organon, Oss, The Netherlands) inserted 24–48 h after delivery
994954|NCT00828516|B1|Baseline|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment
994955|NCT00828516|P1|Participant Flow|Clinical Phase|Breast cancer and head and neck cancer patients with lymphoedema secondary to cancer treatment. Acupuncture and moxibustion, individualised according to participant priorities, delivered once weekly for 7 treatments (Series 1) followed by a further 6 treatments (Series 2) if participant wishes to continue treatment.
994956|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
994957|NCT00828516|O1|Outcome|Usual Care Plus Traditional Acupuncture|All participants were considered stable and were undergoing maintenance treatment for lymphoedema, and were receiving adjunctive acupuncture treatment to promote wellbeing and improve quality of life
994958|NCT00828516|E1|Reported Event|Usual Care Plus Traditional Acupuncture|
994959|NCT00828464|B1|Baseline|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994960|NCT00828464|P1|Participant Flow|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994961|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994962|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994963|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994964|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994965|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994966|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994967|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994968|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994969|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994970|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994971|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994972|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994973|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994974|NCT00828464|O1|Outcome|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994975|NCT00828464|E1|Reported Event|Clobetasol Propionate Foam|All subjects applied clobetasol propionate 0.05% foam twice a day (morning and evening) to the hands.
994976|NCT00828412|B3|Baseline|Total|Total of all reporting groups
994977|NCT00828412|B2|Baseline|Desonide Cream 0.05%|Desonide Cream 0.05%
994978|NCT00828412|B1|Baseline|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
994979|NCT00828412|P2|Participant Flow|Desonide Cream 0.05%|Desonide Cream 0.05% topically twice daily
994980|NCT00828412|P1|Participant Flow|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion topically twice daily
994981|NCT00828412|O2|Outcome|Desonide Cream 0.05%|Week 6 Desonide Cream 0.05%
994982|NCT00828412|O1|Outcome|EpiCeram Skin Barrier Emulsion|Week 6 EpiCeram Skin Barrier Emulsion
994983|NCT00828412|E2|Reported Event|Desonide Cream 0.05%|Desonide Cream 0.05%
994984|NCT00828412|E1|Reported Event|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
994985|NCT00828347|B3|Baseline|Total|Total of all reporting groups
994986|NCT00828347|B2|Baseline|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
1038975|NCT00721175|O2|Outcome|Plastic Stent|Plastic stent group
994987|NCT00828347|B1|Baseline|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
994988|NCT00828347|P2|Participant Flow|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
994989|NCT00828347|P1|Participant Flow|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
994990|NCT00828347|O2|Outcome|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
994991|NCT00828347|O1|Outcome|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
994992|NCT00828347|E2|Reported Event|Low Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
994993|NCT00828347|E1|Reported Event|High Dose Alfacalcidol|oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
994994|NCT00828321|B3|Baseline|Total|Total of all reporting groups
994995|NCT00828321|B2|Baseline|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
994996|NCT00828321|B1|Baseline|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
994997|NCT00828321|P2|Participant Flow|Reference (Altace®) First|10 mg Altace® Capsules reference product dosed in first period followed by 10 mg Ramipril Capsules test product dosed in the second period.
994998|NCT00828321|P1|Participant Flow|Test (Ramipril) First|10 mg Ramipril Capsules test product dosed in first period followed by 10 mg Altace® Capsules reference product dosed in the second period.
994999|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
995000|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
995001|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
995002|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
995003|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
995004|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
995005|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
995006|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
995007|NCT00828321|O2|Outcome|Reference (Altace®)|10 mg Altace® Capsules reference product dosed in either period.
995008|NCT00828321|O1|Outcome|Test (Ramipril)|10 mg Ramipril Capsules test product dosed in either period.
995009|NCT00828308|B1|Baseline|Ixabepilone|Ixabepilone, 16 mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy (this was standard of care and not a part of the study)
995010|NCT00828308|P1|Participant Flow|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy 2-8 weeks after completion of chemotherapy.
995011|NCT00828308|O1|Outcome|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
995012|NCT00828308|E1|Reported Event|Ixabepilone|Ixabepilone, 16 mg/m2 or 20mg/m2, weekly x 3, in 4 week cycles, x 4 cycles. Prostatectomy will occur 2-8 weeks after completion of chemotherapy.
995013|NCT00828295|B3|Baseline|Total|Total of all reporting groups
995014|NCT00828295|B2|Baseline|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
995015|NCT00828295|B1|Baseline|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
995016|NCT00828295|P2|Participant Flow|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
995017|NCT00828295|P1|Participant Flow|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
995018|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
995019|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
995020|NCT00828295|O2|Outcome|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
995021|NCT00828295|O1|Outcome|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
995022|NCT00828295|E2|Reported Event|3 mcg/kg Arm|"Single dose IV Palonosetron 3 mcg/kg (up to a maximum total dose of 0.25 mg)~palonosetron: palonosetron 3mcg/kg IV"
995023|NCT00828295|E1|Reported Event|1 mcg/kg Arm|"Single dose IV Palonosetron 1 mcg/kg (up to a maximum total dose of 0.075 mg)~palonosetron: palonosetron IV 1 mcg/kg"
995024|NCT00828204|B3|Baseline|Total|Total of all reporting groups
995025|NCT00828204|B2|Baseline|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995111|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
995026|NCT00828204|B1|Baseline|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995027|NCT00828204|P2|Participant Flow|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995028|NCT00828204|P1|Participant Flow|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995029|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995030|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995031|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995032|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995033|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995034|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995035|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995071|NCT00828139|B4|Baseline|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
995072|NCT00828139|B3|Baseline|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
996130|NCT00824460|P3|Participant Flow|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
995036|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995037|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995038|NCT00828204|O2|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995039|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995040|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995041|NCT00828204|O1|Outcome|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995042|NCT00828204|E2|Reported Event|Avonex Single-Use Autoinjector: Initial Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Initial Subset participants were enrolled in the Main Study prior to study suspension and could not enroll in the Extension Study."
995043|NCT00828204|E1|Reported Event|Avonex Single-Use Autoinjector: Main Subset|"Participants received open label weekly treatment with Avonex 30 mcg intramuscular (IM) injections, provided in Avonex prefilled syringes.~In the Main Study, injection #1: administration of Avonex prefilled syringe via manual IM injection on Day 1. Injections #2, #3, and #4: administration of Avonex prefilled syringe using the single-use autoinjector on Days 8, 15, and 22, respectively. In the Extension Study, participants were to continue treatment with the Avonex single-use autoinjector for up to an additional 12 weeks.~Main Subset participants were enrolled after study suspension and could enroll in the Extension Study."
995044|NCT00828191|B3|Baseline|Total|Total of all reporting groups
995045|NCT00828191|B2|Baseline|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
995046|NCT00828191|B1|Baseline|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
995047|NCT00828191|P2|Participant Flow|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
995048|NCT00828191|P1|Participant Flow|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
995049|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
995050|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
995051|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
995052|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
995053|NCT00828191|O2|Outcome|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
995054|NCT00828191|O1|Outcome|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
995055|NCT00828191|E2|Reported Event|Progesterone Tablets|Progesterone vaginal tables 100 mg given twice à day.
995056|NCT00828191|E1|Reported Event|Progesterone SC|Progesterone SC given at a daily dose of 25 mg.
995057|NCT00828178|B3|Baseline|Total|Total of all reporting groups
995058|NCT00828178|B2|Baseline|Placebo|corn starch
995059|NCT00828178|B1|Baseline|Fish Oil|3 g of Omega-3 (1.8 g eicosapentaenoic acid, 1.2 g docosahexaenoic acid ethyl esters)
995060|NCT00828178|P2|Participant Flow|Placebo|Placebo (corn starch) once daily
995074|NCT00828139|B1|Baseline|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
995075|NCT00828139|P4|Participant Flow|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
995076|NCT00828139|P3|Participant Flow|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
995077|NCT00828139|P2|Participant Flow|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
995078|NCT00828139|P1|Participant Flow|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
995079|NCT00828139|O2|Outcome|Topotecan|
995080|NCT00828139|O1|Outcome|Ziv-aflibercept + Topotecan|
995081|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
995082|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
995083|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
995084|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
995085|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
995086|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
995087|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
995088|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
995089|NCT00828139|O4|Outcome|Platinum Refractory Treated With Topotecan Aloine|Patients with platinum refractory treated topotecan alone.
995090|NCT00828139|O3|Outcome|Platinum Refractory Treated With Topotecan + Ziv-aflibercept|Patients with platinum refractory (no response and/or treatment-free interval ≤ 90 days for extensive stage and < 180 days for limited stage) treated topotecan and ziv-aflibercept.
995091|NCT00828139|O2|Outcome|Platinum Sensitivity Treated With Topotecan Alone|Patients with platinum sensitivity treated with topotecan alone
995092|NCT00828139|O1|Outcome|Platinum-Sensitive Treated With Topotecan and Ziv-aflibercept|Patients with platinum sensitive (complete response or partial response and > 90 day treatment-free interval for extensive stage or ≥ 180 days for limited stage) were treated with Topotecan and ziv-aflibercept.
995093|NCT00828139|E2|Reported Event|Topotecan|There are total 92 patients in this arm, but only 87 patients with measurable disease at baseline will be included in this analysis.
995094|NCT00828139|E1|Reported Event|Ziv-aflibercept + Topotecan|There are total 97 patients in this arm, but only 92 patients with measurable disease at baseline will be included in this analysis.
995095|NCT00828113|B3|Baseline|Total|Total of all reporting groups
995096|NCT00828113|B2|Baseline|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
995097|NCT00828113|B1|Baseline|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
995098|NCT00828113|P2|Participant Flow|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
995099|NCT00828113|P1|Participant Flow|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
995100|NCT00828113|O2|Outcome|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
995101|NCT00828113|O1|Outcome|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
995102|NCT00828113|E2|Reported Event|Standard Treatment|13 weeks of varenicline therapy + individual smoking cessation counseling
995103|NCT00828113|E1|Reported Event|Extended Treatment|52-week varenicline therapy + individual smoking cessation counseling
995104|NCT00828074|B3|Baseline|Total|Total of all reporting groups
995105|NCT00828074|B2|Baseline|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995106|NCT00828074|B1|Baseline|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995107|NCT00828074|P3|Participant Flow|Phase II - Vinorelbine 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995108|NCT00828074|P2|Participant Flow|Phase I - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995109|NCT00828074|P1|Participant Flow|Phase I - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995110|NCT00828074|O1|Outcome|Phase I & II|"Patients receive sorafenib tosylate PO twice daily on days 1-28 and vinorelbine ditartrate IV on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Dose level 1 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle. Dose level 2 = 200 mg by mouth two times a day on days 1-28 of a 28 day cycle.~vinorelbine ditartrate: Dose level 1 = 20 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle. Dose level 2 = 25 mg/m2 IV weekly on days 1, 8, and 15 of a 28 day cycle."
995112|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
995113|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
995114|NCT00828074|O1|Outcome|Dose Level II - Vinorelbine I.V. 20 mg/m^2|Vinorelbine I.V. at 20 mg/m^2 weekly on days 1, 8, 15 and sorafenib at 200 mg given orally twice daily.
995115|NCT00828074|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
995116|NCT00828074|O2|Outcome|Phase I: Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995117|NCT00828074|O1|Outcome|Phase I: Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995118|NCT00828074|E2|Reported Event|Dose Level 2 - Vinorelbine at 25mg/m^2|Vinorelbine at 25mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995119|NCT00828074|E1|Reported Event|Dose Level 1 - Vinorelbine at 20mg/m^2|Vinorelbine at 20mg/m^2 weekly intravenous (I.V.) on days 1, 8, 15 and sorafenib 200 mg given orally (p.o.) twice daily for 28 days
995120|NCT00828061|B1|Baseline|All Patients|All patients who completed at least one period are included in the analysis
995121|NCT00828061|P6|Participant Flow|Prednisone / Prednisone / Placebo|1 day 25 mg prednisone, 1 day 10 mg prednisone, 1 day placebo
995122|NCT00828061|P5|Participant Flow|Prednisone / Placebo / Prednisone|1 day 10 mg prednisone, 1 day placebo, 1 day 25 mg prednisone
995123|NCT00828061|P4|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 25 mg prednisone, 1 day 10 mg prednisone
995124|NCT00828061|P3|Participant Flow|Prednisone / Placebo / Prednisone|1 day 25 mg prednisone, 1 day placebo, 1 day 10 mg prednisone
995125|NCT00828061|P2|Participant Flow|Prednisone / Prednisone / Placebo|1 day 10 mg prednisone, 1 day 25 mg prednisone, 1 day placebo
995126|NCT00828061|P1|Participant Flow|Placebo / Prednisone / Prednisone|1 day placebo, 1 day 10 mg prednisone, 1 day 25 mg prednisone
995127|NCT00828061|O3|Outcome|25 mg Prednisone|
995128|NCT00828061|O2|Outcome|10 mg Prednisone|
995129|NCT00828061|O1|Outcome|Placebo|
995130|NCT00828061|O3|Outcome|25 mg Prednisone|
995131|NCT00828061|O2|Outcome|10 mg Prednisone|
995132|NCT00828061|O1|Outcome|Placebo|
995133|NCT00828061|E3|Reported Event|25 mg Prednisone|
995134|NCT00828061|E2|Reported Event|10 mg Prednisone|
995135|NCT00828061|E1|Reported Event|Placebo|
995136|NCT00827983|B3|Baseline|Total|Total of all reporting groups
995137|NCT00827983|B2|Baseline|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995138|NCT00827983|B1|Baseline|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995139|NCT00827983|P2|Participant Flow|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995140|NCT00827983|P1|Participant Flow|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995141|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995142|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995143|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995144|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995145|NCT00827983|O2|Outcome|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995146|NCT00827983|O1|Outcome|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995147|NCT00827983|E2|Reported Event|Progesterone Vaginal Gel|Progesterone Vaginal gel was administered at a daily dosage of 90 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995148|NCT00827983|E1|Reported Event|Progesterone SC|Progesterone SC was administered at a daily dosage of 25 mg during a minimum of two weeks (in case of no pregnancy) to a maximum of 10 weeks (in case of pregnancy)
995149|NCT00827944|B3|Baseline|Total|Total of all reporting groups
995150|NCT00827944|B2|Baseline|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995151|NCT00827944|B1|Baseline|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995152|NCT00827944|P2|Participant Flow|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995153|NCT00827944|P1|Participant Flow|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
997015|NCT00822900|O1|Outcome|Progesterone|
995183|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995154|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995155|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995156|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995157|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995158|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995159|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995160|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995161|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995162|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995163|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995164|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995165|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995166|NCT00827944|O2|Outcome|Lichtenstein Group|"Low weight polypropylene mesh~Low weight polypropylene mesh : Surgical technique:~Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995167|NCT00827944|O1|Outcome|Progrip Group|"Parietex ProGrip~Parietex Progrip : Surgical technique:~Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995168|NCT00827944|E2|Reported Event|Lichtenstein Group|"Low weight polypropylene mesh~Surgical technique: Lichtenstein repair with lightweight polypropylene mesh (inferior to 70gr/m2) secured to the posterior inguinal wall with sutures"
995169|NCT00827944|E1|Reported Event|Progrip Group|"Parietex ProGrip~Surgical technique: Self-gripping lightweight Polyester and Polylactic acid meshes providing a sutureless fixation."
995170|NCT00827931|B3|Baseline|Total|Total of all reporting groups
995171|NCT00827931|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995172|NCT00827931|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995173|NCT00827931|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995174|NCT00827931|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995175|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995176|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995177|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995178|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995179|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995180|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995181|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995182|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
997016|NCT00822900|O2|Outcome|Placebo|
995184|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995185|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995186|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995187|NCT00827931|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995188|NCT00827931|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995189|NCT00827931|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
995190|NCT00827931|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg)/kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
995191|NCT00827918|B4|Baseline|Total|Total of all reporting groups
995192|NCT00827918|B3|Baseline|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995193|NCT00827918|B2|Baseline|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995194|NCT00827918|B1|Baseline|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995195|NCT00827918|P3|Participant Flow|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995196|NCT00827918|P2|Participant Flow|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995197|NCT00827918|P1|Participant Flow|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995198|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995199|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995200|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995201|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995202|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995203|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995204|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995205|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995206|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995207|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995208|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995209|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995210|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995211|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995212|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995213|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995214|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995215|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995216|NCT00827918|O3|Outcome|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995217|NCT00827918|O2|Outcome|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995218|NCT00827918|O1|Outcome|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995219|NCT00827918|E3|Reported Event|Placebo Comparator|Placebo Comparator to MK-8998 or olanzapine
995220|NCT00827918|E2|Reported Event|Olanzapine|Olanzapine, 5 mg BID on Day 1 to 7, and 15 mg (5 mg in the morning and 10 mg in the evening) thereafter for a 4-week total treatment period
995221|NCT00827918|E1|Reported Event|MK-8998|MK-8998, 6 mg twice a day (BID) on Days 1 to 7, and 8 mg BID thereafter for a 4-week total treatment period
995222|NCT00827827|B3|Baseline|Total|Total of all reporting groups
995401|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995473|NCT00826943|B1|Baseline|All Study Participants|Cross Over (all participants received all interventions)
995223|NCT00827827|B2|Baseline|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995224|NCT00827827|B1|Baseline|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995225|NCT00827827|P2|Participant Flow|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995226|NCT00827827|P1|Participant Flow|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995227|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995228|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995229|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995230|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995231|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995232|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995233|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995234|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995235|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995236|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995468|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%~topical anesthetic"
995237|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995238|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995239|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995240|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995241|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995242|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995243|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995244|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995245|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995246|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995247|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995248|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995249|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995250|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995469|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
995251|NCT00827827|O2|Outcome|Stretching Controls|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995252|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995253|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995254|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995255|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995256|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995257|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995258|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995259|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995260|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995261|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995262|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995263|NCT00827827|O2|Outcome|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995264|NCT00827827|O1|Outcome|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995470|NCT00827073|O1|Outcome|Tetracaine 0.5% Drop|"betadine: betadine 5%~topical anesthetic"
995265|NCT00827827|E2|Reported Event|Stretching Control|"Participants in this group receive equal exposure to study staff compared with the experimental ST group (approximately 45 minutes to 1 hour 3 times per week). Exercise sessions for this group involve a full battery of active and passive...upper and lower body...stretching and range of motion exercises performed on raised padded tables.~Exercise- Stretching Control: 3x per week upper and lower body stretching mixed with active and passive range of motion exercises"
995266|NCT00827827|E1|Reported Event|Strength Training|"Participants in this group undergo lower-extremity strength training on three pneumatic resistance machines (Keiser Leg Press, Keiser Leg Extension, and Keiser Leg Curl). Training sessions happen 3 times per week (M,W,F) and last approximately 45 minutes to 1 hour. Participants in this group exercise each limb individually to account for the large discrepancies in strength between legs in stroke survivors.~Exercise- Strength Training: 3x per week lower-extremity ST lasting approximately 45 minutes to 1 hour."
995267|NCT00827632|B3|Baseline|Total|Total of all reporting groups
995268|NCT00827632|B2|Baseline|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
995269|NCT00827632|B1|Baseline|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
995270|NCT00827632|P2|Participant Flow|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
995271|NCT00827632|P1|Participant Flow|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
995272|NCT00827632|O2|Outcome|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
995273|NCT00827632|O1|Outcome|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
995274|NCT00827632|E2|Reported Event|Obese|Participants with a Body Mass Index (BMI) of 30-39.9.
995275|NCT00827632|E1|Reported Event|Normal Weight|Participants with a Body Mass Index (BMI) of 19-24.9.
995276|NCT00827606|B3|Baseline|Total|Total of all reporting groups
995277|NCT00827606|B2|Baseline|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995278|NCT00827606|B1|Baseline|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995279|NCT00827606|P2|Participant Flow|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged greater than or equal to (≥) 10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995280|NCT00827606|P1|Participant Flow|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to less than (<)10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 milligrams per day (mg/day), orally (PO), through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target low-density lipoprotein cholesterol (LDL-C) (<3.35 millimoles per liter [mmol/L]) was not attained.
995281|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995282|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995283|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995284|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995285|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995286|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995287|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995288|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995315|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
997017|NCT00822900|O1|Outcome|Progesterone|
995289|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995290|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995291|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995292|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995293|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995294|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995295|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995296|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995297|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995298|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995299|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995300|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995301|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995302|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995303|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995304|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg)|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained. Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995305|NCT00827606|O5|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 5|Participants aged ≥10 to 15 years, at Tanner_Stage 5 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995306|NCT00827606|O4|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 4|Participants aged ≥10 to 15 years, at Tanner_Stage 4 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995307|NCT00827606|O3|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 3|Participants aged ≥10 to 15 years, at Tanner_Stage 3 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, PO, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995308|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Baseline Tanner_Stage 2|Participants aged ≥10 to 15 years, at Tanner_Stage 2 received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995309|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Baseline Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, PO, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995310|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995311|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995312|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995313|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995314|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
997018|NCT00822900|O2|Outcome|Placebo|
995316|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995317|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995318|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995319|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995320|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995321|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995322|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995323|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995324|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995325|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995326|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995327|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995328|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995329|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995330|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995331|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995332|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995333|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995334|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995335|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995336|NCT00827606|O2|Outcome|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995337|NCT00827606|O1|Outcome|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995338|NCT00827606|E2|Reported Event|Atorvastatin (10-80 mg): Tanner_Stage 2+|Participants aged ≥10 to 15 years, at Tanner_Stage 2+ received an initial dose of atorvastatin tablets, 10 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 20 mg/day, with subsequent doubling to 40 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995339|NCT00827606|E1|Reported Event|Atorvastatin (5-80 mg): Tanner_Stage 1|Participants aged 6 to <10 years, at Tanner_Stage 1 received an initial dose of atorvastatin tablets, 5 mg/day, PO, through Week 4; after Week 4, dose may have been doubled to 10 mg/day, with subsequent doubling to 20 mg/day (as necessary; maximum dose was 80 mg/day), PO, if target LDL-C (<3.35 mmol/L) was not attained.
995340|NCT00827567|B1|Baseline|RAD 001|RAD001-10 mg by mouth once everyday
995341|NCT00827567|P1|Participant Flow|RAD 001|RAD001-10 mg by mouth once everyday
995342|NCT00827567|O1|Outcome|RAD 001|RAD001-10 mg by mouth once everyday
995343|NCT00827567|E1|Reported Event|RAD 001|RAD001-10 mg by mouth once everyday
995344|NCT00827541|B3|Baseline|Total|Total of all reporting groups
995345|NCT00827541|B2|Baseline|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995346|NCT00827541|B1|Baseline|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995347|NCT00827541|P2|Participant Flow|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995348|NCT00827541|P1|Participant Flow|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995349|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995350|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995351|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995352|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995353|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995354|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995355|NCT00827541|O2|Outcome|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995356|NCT00827541|O1|Outcome|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995357|NCT00827541|E2|Reported Event|Complicated Intra-Abdominal Infections|Participants with Complicated Intra-Abdominal Infections (cIAI) received tigecycline (Tygacil) at an initial dose of 100 mg followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995358|NCT00827541|E1|Reported Event|Complicated Skin and Soft-tissue Infections|Participants with Complicated Skin and Soft-tissue Infections (cSSTI) received tigecycline (Tygacil) at an initial dose of 100 milligram (mg) followed by 50 mg every 12 hours intravenously for 5 to 14 days based on local prescribing practices.
995359|NCT00827502|B1|Baseline|Azithromycin|
995399|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995400|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
997019|NCT00822900|O1|Outcome|Progesterone|
995360|NCT00827502|P1|Participant Flow|Azithromycin|The use and dosage recommendations for Azithromycin took place on the basis of the approved local product document (LPD) and were adjusted solely according to medical and therapeutic necessities. According to the approved LPD, in general a total dose of 30 mg/kg was given as a single daily dose(10 mg/kg daily for 3 days, or given over 5 days with a single daily dose of 10 mg/kg on day 1, and then reduced to 5 mg/kg on days 2 to 5). For children with acute otitis media a single dose of 30 mg/kg was recommended. Children with streptococcal pharyngitis were given a single dose of 10 mg/kg or 20 mg/kg for 3 days and did not exceed a daily dose of 500mg. The maximum recommended total dose of Azithromycin in children for any treatment was 1500 mg. Azithromycin tablets were administered only to children weighing more than 45 kg.
995361|NCT00827502|O1|Outcome|Azithromycin|
995362|NCT00827502|O1|Outcome|Azithromycin|
995363|NCT00827502|O1|Outcome|Azithromycin|
995364|NCT00827502|E1|Reported Event|Azithromycin|
995365|NCT00827372|B1|Baseline|Overall Study|All patients who were treated
995366|NCT00827372|P1|Participant Flow|Overall Study|All patients who were treated
995367|NCT00827372|O1|Outcome|Overall|All patients who were treated
995368|NCT00827372|O1|Outcome|Overall|All patients who were treated
995369|NCT00827372|O1|Outcome|Overall|All patients who were treated
995370|NCT00827372|O1|Outcome|Overall|All patients who were treated
995371|NCT00827372|O1|Outcome|Overall Study|All patients who were treated
995372|NCT00827372|E1|Reported Event|Overall|All patients who were treated
995373|NCT00827255|B1|Baseline|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
995374|NCT00827255|P1|Participant Flow|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
995375|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
995376|NCT00827255|O1|Outcome|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
995377|NCT00827255|E1|Reported Event|Patients Who Received Restasis®|Patients who received Restasis® (cyclosporine ophthalmic emulsion 0.05%)
995378|NCT00827242|B3|Baseline|Total|Total of all reporting groups
995379|NCT00827242|B2|Baseline|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995380|NCT00827242|B1|Baseline|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995381|NCT00827242|P2|Participant Flow|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995382|NCT00827242|P1|Participant Flow|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995383|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995384|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995385|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995386|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995387|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995388|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995389|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995390|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995391|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995392|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995393|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995394|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995395|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995396|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995397|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995398|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
997020|NCT00822900|O2|Outcome|Placebo|
995402|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995403|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995404|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995405|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995406|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995407|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995408|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995409|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995410|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995411|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995412|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995413|NCT00827242|O2|Outcome|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995414|NCT00827242|O1|Outcome|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995415|NCT00827242|E2|Reported Event|Placebo|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive placebo orally once daily over a 12-week period.
995416|NCT00827242|E1|Reported Event|Tadalafil|Following screening, a 4-week washout period (if needed) and a 4-week placebo lead-in period, subjects were randomized to receive tadalafil 5 mg orally once daily over a 12-week period.
995417|NCT00827112|B3|Baseline|Total|Total of all reporting groups
995418|NCT00827112|B2|Baseline|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995419|NCT00827112|B1|Baseline|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995420|NCT00827112|P2|Participant Flow|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995421|NCT00827112|P1|Participant Flow|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995422|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995423|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995424|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995425|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995426|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995427|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995428|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995429|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995430|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995431|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995432|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995471|NCT00827073|E2|Reported Event|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
997021|NCT00822900|O1|Outcome|Progesterone|
995433|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995434|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995435|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995436|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995437|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995438|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995439|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995440|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995441|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995442|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995443|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995444|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995445|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995446|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995447|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995448|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995449|NCT00827112|O2|Outcome|Atazanavir / Ritonavir + Emtricitabine / Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets once daily along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995450|NCT00827112|O1|Outcome|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir/ritonavir 300 mg/100 mg tablets once daily were orally administered for 96 weeks.
995451|NCT00827112|E2|Reported Event|Atazanavir / Ritonavir + Emtricitabine/ Tenofovir|Atazanavir/ritonavir 300 mg/100 mg tablets QD along with emtricitabine/tenofovir 200 mg/245 mg tablets once daily were orally administered for 96 weeks.
995452|NCT00827112|E1|Reported Event|Maraviroc+ Atazanavir / Ritonavir|Maraviroc 150 milligram (mg) tablets once daily along with atazanavir 300 mg or ritonavir 100 mg tablets once daily were orally administered for 96 weeks.
995453|NCT00827099|B1|Baseline|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
995454|NCT00827099|P1|Participant Flow|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
995455|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
995456|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
995457|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
995458|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
995459|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
995460|NCT00827099|O1|Outcome|Umbilical Cord Blood Transplant|High dose conditioning with Fludarabine & Melphalan
995461|NCT00827099|E1|Reported Event|Umbilical Cord Blood Transplantation|"Fludarabine 30 mg^m2 on days -7, -6, -5, -4 & -3~Melphalan 140 mg^m2 on day -2~Rabbit antithymocyte globulin (ATG) 6mg/kg divided over 3 days, Days -4,-3,-2. (Thymoglobulin 1.0mg/kg on day -4, and 2.5mg/kg/d on days -3, -2)~Tacrolimus starting on day -1 as a continuous infusion of 0.03 mg/kg/d.~Mycophenolate mofetil (MMF) IV 15mg/kg BID will start on Day 0"
995462|NCT00827073|B3|Baseline|Total|Total of all reporting groups
995463|NCT00827073|B2|Baseline|Lidocaine 2% Jelly|"betadine: betadine 5%~anesthetic"
995464|NCT00827073|B1|Baseline|Tetracaine 5% Drop|"betadine: betadine 5%~topical anesthetic"
995465|NCT00827073|P2|Participant Flow|Lidocaine 2% Jelly|betadine: betadine 5% Anesthetic: lidocaine 2% jelly
995466|NCT00827073|P1|Participant Flow|Tetracaine 5% Drop|betadine: betadine 5%, topical anesthetic drop
995467|NCT00827073|O2|Outcome|Lidocaine 2% Jelly|"betadine: betadine 5%~Anesthetic"
995474|NCT00826943|P6|Participant Flow|C Then P Then L|cetirizine 10 mg daily x 7 days then placebo daily x 7 days then levocetirizine 5 mg daily x 7 days (wash out periods before and after each)
995475|NCT00826943|P5|Participant Flow|C Then L Then P|cetirizine 10 mg daily x 7 days then levocetirizine 5 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
995476|NCT00826943|P4|Participant Flow|P Then C Then L|placebo daily x 7 days then cetirizine 10 mg daily x 7 days then levocetirizine daily x 7 days (wash out periods before and after each)
995477|NCT00826943|P3|Participant Flow|P Then L Then C|placebo daily x 7 days then levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days (wash out periods before and after each)
995478|NCT00826943|P2|Participant Flow|L Then P Then C|Levocetirizine 5 mg daily x 7 days then placebo daily x 7 days then cetiriznie 10 mg daily x 7 days (wash out periods before and after each)
995479|NCT00826943|P1|Participant Flow|L Then C Then P|Levocetirizine 5 mg daily x 7 days then cetirizine 10 mg daily x 7 days then placebo daily x 7 days (wash out periods before and after each)
995480|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
995481|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
995482|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
995483|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
995484|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
995485|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
995486|NCT00826943|O3|Outcome|Cetirizine|cross over = all participants received all interventions
995487|NCT00826943|O2|Outcome|Levocetirizine|cross over (all participants received all interventions)
995488|NCT00826943|O1|Outcome|Placebo|Cross Over (all participants received all interventions)
995489|NCT00826943|E3|Reported Event|Cetirizine|cross over = all participants received all interventions
995490|NCT00826943|E2|Reported Event|Levocetirizine|cross over (all participants received all interventions)
995491|NCT00826943|E1|Reported Event|Placebo|Cross Over (all participants received all interventions)
995492|NCT00826800|B1|Baseline|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
995493|NCT00826800|P1|Participant Flow|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
995494|NCT00826800|O1|Outcome|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
995495|NCT00826800|E1|Reported Event|Neoadjuvant FOLFOX Plus Bevacizumab|FOLFOX and bevacizumab: The patient will receive six treatments, two weeks apart. On each treatment day patient will get Oxaliplatin, 5-FU,Leucovorin. On the first four treatments, patient will also get Bevacizumab (Avastin).
995496|NCT00826618|B1|Baseline|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
995497|NCT00826618|P1|Participant Flow|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
995498|NCT00826618|O1|Outcome|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME. Mean change in BCVA (assessed by the ETDRS chart at 4 m) from baseline at 12 months was 12.2 ETDRS letters (P = 0.015).
995499|NCT00826618|E1|Reported Event|Ranibizumab|ranibizumab: This is an open-label, Phase I study of intravitreally administered 0.5mg ranibizumab in subjects with uveitic CME.
995500|NCT00826540|B1|Baseline|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >~> bevacizumab: Given IV"
995501|NCT00826540|P1|Participant Flow|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies > > sorafenib tosylate: Given orally >~> bevacizumab: Given IV"
995502|NCT00826540|O1|Outcome|Treatment (Sorafenib Tosylate and Bevacizumab)|"Patients receive sorafenib tosylate orally twice daily on days 1-5 and 8-12 and bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity. Blood samples are collected at baseline and then periodically during study treatment for laboratory biomarker and pharmacogenetic studies >~> sorafenib tosylate: Given orally~>~> bevacizumab: Given IV"
995503|NCT00826540|E1|Reported Event|Treatment (Sorafenib Tosylate and Bevacizumab)|bevacizumab: Given IV
995504|NCT00826449|B3|Baseline|Total|Total of all reporting groups
995505|NCT00826449|B2|Baseline|Dasatinib + Erlotinib: Phase 2|MTD from Phase I Dasatinib orally dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
995506|NCT00826449|B1|Baseline|Dasatinib + Erlotinib: Phase I|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
995507|NCT00826449|P1|Participant Flow|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
995508|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
995509|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
995510|NCT00826449|O1|Outcome|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
996132|NCT00824460|P1|Participant Flow|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
995511|NCT00826449|E1|Reported Event|Dasatinib + Erlotinib|Dasatinib orally starting dose 70 mg/day & Erlotinib 150 mg orally/day every 21 day cycle.
995512|NCT00826280|B4|Baseline|Total|Total of all reporting groups
995513|NCT00826280|B3|Baseline|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995514|NCT00826280|B2|Baseline|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995515|NCT00826280|B1|Baseline|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995516|NCT00826280|P3|Participant Flow|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995517|NCT00826280|P2|Participant Flow|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995518|NCT00826280|P1|Participant Flow|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995519|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995520|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995521|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995522|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995523|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995524|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995525|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995526|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995527|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995528|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995529|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995530|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995531|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995532|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995533|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995534|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995535|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995536|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995537|NCT00826280|O3|Outcome|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995538|NCT00826280|O2|Outcome|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995539|NCT00826280|O1|Outcome|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995540|NCT00826280|E3|Reported Event|Caffeine 400 mg Plus Regadenoson|Two 200 mg Caffeine capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995541|NCT00826280|E2|Reported Event|Caffeine 200 mg Plus Regadenoson|One 200 mg Caffeine capsule and one placebo capsule plus 0.4 mg regadenoson per 5mL intravenous bolus injection
995542|NCT00826280|E1|Reported Event|Placebo Plus Regadenoson|Two Placebo capsules plus 0.4 mg regadenoson per 5mL intravenous (IV) bolus injection
995543|NCT00826267|B4|Baseline|Total|Total of all reporting groups
995544|NCT00826267|B3|Baseline|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
995545|NCT00826267|B2|Baseline|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995546|NCT00826267|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995547|NCT00826267|P3|Participant Flow|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
995548|NCT00826267|P2|Participant Flow|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995549|NCT00826267|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995550|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
995551|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
996066|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
997022|NCT00822900|O2|Outcome|Placebo|
995552|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995553|NCT00826267|O1|Outcome|Afatinib 50mg|Patients received Afatinib 50 mg at day 7.
995554|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
995555|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995556|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995557|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
995558|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995559|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995560|NCT00826267|O3|Outcome|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
995561|NCT00826267|O2|Outcome|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995562|NCT00826267|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995563|NCT00826267|E3|Reported Event|Trastuzumab|Patients received weekly trastuzumab infusions of 2 mg/kg following a loading dose of 4 mg/kg per SPC. 6 infusions were to be given over 2 treatment courses.
995564|NCT00826267|E2|Reported Event|Lapatinib 1500 mg|Patients received continuous daily dosing with Lapatinib 1500 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995565|NCT00826267|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg orally from Day 1 to Day 21 of each treatment course. 2 treatment courses were to be given in the trial.
995566|NCT00826228|B1|Baseline|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
995567|NCT00826228|P1|Participant Flow|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing on a Lokomat
995568|NCT00826228|O1|Outcome|PTH/Weight-Bearing|
995569|NCT00826228|O1|Outcome|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
995570|NCT00826228|E1|Reported Event|PTH/Weight-Bearing|PTH 20ug/day plus assisted weight-bearing of one hour 3x/week
995571|NCT00826202|B3|Baseline|Total|Total of all reporting groups
995572|NCT00826202|B2|Baseline|Placebo|Placebo: Inert Placebo
995573|NCT00826202|B1|Baseline|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
995574|NCT00826202|P2|Participant Flow|Placebo|Placebo: Inert Placebo
995575|NCT00826202|P1|Participant Flow|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
995576|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
995577|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
995578|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
995579|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
995580|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
995581|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
995582|NCT00826202|O2|Outcome|Placebo|Placebo: Inert Placebo
995583|NCT00826202|O1|Outcome|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
995584|NCT00826202|E2|Reported Event|Placebo|Placebo: Inert Placebo
995585|NCT00826202|E1|Reported Event|D Serine|"60 mg/kg/day~D-serine: 60 mg/kg/day"
995586|NCT00826176|B3|Baseline|Total|Total of all reporting groups
995587|NCT00826176|B2|Baseline|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
995588|NCT00826176|B1|Baseline|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
995589|NCT00826176|P2|Participant Flow|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
995590|NCT00826176|P1|Participant Flow|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
995591|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
995592|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
995593|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
995594|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
995595|NCT00826176|O2|Outcome|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
995596|NCT00826176|O1|Outcome|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
996067|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
995597|NCT00826176|E2|Reported Event|Sugammadex in Caucasian Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Caucasian subjects living in Europe.
995598|NCT00826176|E1|Reported Event|Sugammadex in Chinese Subjects|At 1-2 post-tetanic counts (PTC) after the last dose of rocuronium, 4.0 mg.kg-1 sugammadex was to be administered. Chinese subjects living in China.
995599|NCT00826111|B3|Baseline|Total|Total of all reporting groups
995600|NCT00826111|B2|Baseline|Placebo|Escitalopram with placebo
995601|NCT00826111|B1|Baseline|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995602|NCT00826111|P2|Participant Flow|Placebo|Escitalopram with placebo
995603|NCT00826111|P1|Participant Flow|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995604|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995605|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995606|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995607|NCT00826111|O1|Outcome|Eszopiclone|Escitalopram for 10 weeks together with eszopiclone.
995608|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995609|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995610|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995611|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995612|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995613|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995614|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995615|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995616|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995617|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995618|NCT00826111|O2|Outcome|Placebo|Escitalopram with placebo
995619|NCT00826111|O1|Outcome|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995620|NCT00826111|O2|Outcome|Placebo|Open label escitalopram for 10 weeks together with placebo for 10 weeks.
995621|NCT00826111|O1|Outcome|Eszopiclone|Open label escitalopram for 10 weeks together with 3 mg eszopiclone for eight weeks followed by placebo for two weeks.
995622|NCT00826111|E2|Reported Event|Placebo|Escitalopram with placebo
995623|NCT00826111|E1|Reported Event|Eszopiclone|Lexapro for 10 weeks together with eszopiclone.
995624|NCT00826007|B3|Baseline|Total|Total of all reporting groups
995625|NCT00826007|B2|Baseline|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
995626|NCT00826007|B1|Baseline|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
995627|NCT00826007|P2|Participant Flow|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
995628|NCT00826007|P1|Participant Flow|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
995629|NCT00826007|O2|Outcome|Hyperglycemia-treated Group|Patients with diabetes who had preoperative blood glucose values >249 mg/dl and were subsequently treated with insulin
995630|NCT00826007|O1|Outcome|Low Normal Group|Patients with diabetes who arrived in preoperative area with blood glucose values of 70-89 mg/dl
995631|NCT00826007|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
995632|NCT00825994|B1|Baseline|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
995633|NCT00825994|P1|Participant Flow|Omega-3|omega-3 fatty acids, 2g qd [every day] (2 x 1 gram tablets), PO [by mouth]
995634|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
995635|NCT00825994|O1|Outcome|Omega-3 Fatty Acids|We conducted an open label study of omega-3 fatty acids for the treatment of major depressive disorder (MDD) in women who were perimenopausal or postmenopausal.
995636|NCT00825994|E1|Reported Event|Omega-3|omega-3 fatty acids, 2g qd (2 x 1 gram tablets), PO
995637|NCT00825916|B4|Baseline|Total|Total of all reporting groups
995638|NCT00825916|B3|Baseline|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995639|NCT00825916|B2|Baseline|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995640|NCT00825916|B1|Baseline|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995641|NCT00825916|P3|Participant Flow|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995642|NCT00825916|P2|Participant Flow|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995643|NCT00825916|P1|Participant Flow|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995644|NCT00825916|O9|Outcome|Scar Total Volume - 10 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995645|NCT00825916|O8|Outcome|Scar Total Volume - 3 mg AZX100|This group included Month 12 scar total volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995646|NCT00825916|O7|Outcome|Scar Total Volume - Placebo|This group included Month 12 scar total volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
996131|NCT00824460|P2|Participant Flow|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
995647|NCT00825916|O6|Outcome|Scar Negative Volume - 10 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995648|NCT00825916|O5|Outcome|Scar Negative Volume - 3 mg AZX100|This group included Month 12 scar negative volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995649|NCT00825916|O4|Outcome|Scar Negative Volume - Placebo|This group included Month 12 scar negative volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995650|NCT00825916|O3|Outcome|Scar Positive Volume - 10 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995651|NCT00825916|O2|Outcome|Scar Positive Volume - 3 mg AZX100|This group included Month 12 scar positive volume (mm^3) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995652|NCT00825916|O1|Outcome|Scar Positive Volume - Placebo|This group included Month 12 scar positive volume (mm^3) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995653|NCT00825916|O15|Outcome|Scar Mean Elevation - 10 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995654|NCT00825916|O14|Outcome|Scar Mean Elevation - 3 mg AZX100|This group included Month 12 scar mean elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995655|NCT00825916|O13|Outcome|Scar Mean Elevation - Placebo|This group included Month 12 scar mean elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995656|NCT00825916|O12|Outcome|Scar Maximum Elevation - 10 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995657|NCT00825916|O11|Outcome|Scar Maximum Elevation - 3 mg AZX100|This group included Month 12 scar maximum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995658|NCT00825916|O10|Outcome|Scar Maximum Elevation - Placebo|This group included Month 12 scar maximum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995659|NCT00825916|O9|Outcome|Scar Minimum Elevation - 10 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995660|NCT00825916|O8|Outcome|Scar Minimum Elevation - 3 mg AZX100|This group included Month 12 scar minimum elevation (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995661|NCT00825916|O7|Outcome|Scar Minimum Elevation - Placebo|This group included Month 12 scar minimum elevation (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995662|NCT00825916|O6|Outcome|Scar Width - 10 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995663|NCT00825916|O5|Outcome|Scar Width - 3 mg AZX100|This group included Month 12 scar width (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995664|NCT00825916|O4|Outcome|Scar Width - Placebo|This group included Month 12 scar width (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995665|NCT00825916|O3|Outcome|Scar Length - 10 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995666|NCT00825916|O2|Outcome|Scar Length - 3 mg AZX100|This group included Month 12 scar length (mm) measurements for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995667|NCT00825916|O1|Outcome|Scar Length - Placebo|This group included Month 12 scar length (mm) measurements for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995668|NCT00825916|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995669|NCT00825916|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995670|NCT00825916|O4|Outcome|Rater 2 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995671|NCT00825916|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100|This group included Month 12 VAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995672|NCT00825916|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100|This group included Month 12 VAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995673|NCT00825916|O1|Outcome|Rater 1 VAS Scores for Placebo|This group included Month 12 VAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995674|NCT00825916|O6|Outcome|OSAS Results for 10 mg AZX100|This group included Month 12 OSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995675|NCT00825916|O5|Outcome|OSAS Results for 3 mg AZX100|This group included Month 12 OSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995676|NCT00825916|O4|Outcome|OSAS Results for Placebo|This group included Month 12 OSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995677|NCT00825916|O3|Outcome|PSAS Results for 10 mg AZX100|This group included Month 12 PSAS scores for patients who received 10 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995678|NCT00825916|O2|Outcome|PSAS Results for 3 mg AZX100|This group included Month 12 PSAS scores for patients who received 3 mg AZX100/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995679|NCT00825916|O1|Outcome|PSAS Results for Placebo|This group included Month 12 PSAS scores for patients who received placebo (saline)/linear centimeter intradermally along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995680|NCT00825916|E3|Reported Event|Low Dose|AZX100 Drug Product 3 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995681|NCT00825916|E2|Reported Event|Placebo|Placebo (0.9% saline) was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995682|NCT00825916|E1|Reported Event|High Dose|AZX100 Drug Product 10 mg was administered intradermally per linear centimeter along the excision line following keloid scar excision at 21 days and 42 days after surgery.
995683|NCT00825825|B1|Baseline|Entire Study Population|Includes all randomized subjects regardless of order in which they received medications
995684|NCT00825825|P6|Participant Flow|Placebo First / Citalopram Second / Escitalopram Third|2 weeks of placebo followed by 2 weeks of citalopram followed by 2 weeks escitalopram
995685|NCT00825825|P5|Participant Flow|Placebo First / Escitalopram Second / Citalopram Third|2 weeks of placebo followed by 2 weeks of escitalopram followed by 2 weeks of citalopram
995686|NCT00825825|P4|Participant Flow|Citalopram First / Placebo Second / Escitalopram Third|2 weeks of citalopram followed by 2 weeks of placebo followed by 2 weeks of escitalopram
995687|NCT00825825|P3|Participant Flow|Citalopram First / Escitalopram Second / Placebo Third|2 weeks of citalopram followed by 2 weeks of escitalopram followed by 2 weeks of placebo
995688|NCT00825825|P2|Participant Flow|Escitalopram First / Placebo Second / Citalopram Third|2 weeks of escitalopram followed by 2 weeks of placebo followed by 2 weeks of citalopram
995689|NCT00825825|P1|Participant Flow|Escitalopram First / Citalopram Second / Placebo Third|2 weeks of escitalopram followed by 2 weeks of citalopram followed by 2 weeks of placebo
995690|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
995691|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
995692|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
995693|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
995694|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
995695|NCT00825825|O1|Outcome|All Participants With Complete Usuable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
995696|NCT00825825|O1|Outcome|All Participants With Complete Usable Data|Participants were healthy volunteers who completed three medication periods of two weeks each (escitalopram, citalopram, and placebo) and had a successful magnetic resonance scan at the end of each medication period. The study design was a randomized crossover trial so all individuals received all interventions.
995697|NCT00825825|E3|Reported Event|Placebo|Includes all subjects who received placebo in one of the three medication periods
995698|NCT00825825|E2|Reported Event|Citalopram|Includes all subjects who received citalopram in one of the three medication periods
995699|NCT00825825|E1|Reported Event|Escitalopram|Includes all subjects who received escitalopram in one of the three medication periods
995700|NCT00825812|B5|Baseline|Total|Total of all reporting groups
995701|NCT00825812|B4|Baseline|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995702|NCT00825812|B3|Baseline|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995703|NCT00825812|B2|Baseline|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995704|NCT00825812|B1|Baseline|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995705|NCT00825812|P4|Participant Flow|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995706|NCT00825812|P3|Participant Flow|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995707|NCT00825812|P2|Participant Flow|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995708|NCT00825812|P1|Participant Flow|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995709|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995710|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995711|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995712|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995713|NCT00825812|O4|Outcome|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995714|NCT00825812|O3|Outcome|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995715|NCT00825812|O2|Outcome|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995716|NCT00825812|O1|Outcome|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995717|NCT00825812|E4|Reported Event|Neostigmine in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995718|NCT00825812|E3|Reported Event|Sugammadex in Chinese Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995719|NCT00825812|E2|Reported Event|Neostigmine in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 50 μg.kg-1 neostigmine (combined with 10-20 μg.kg-1 atropine, in a ratio ranging from 2.5:1 to 5:1) was administered.
995720|NCT00825812|E1|Reported Event|Sugammadex in Caucasian Subjects|At reappearance of T2 after the last dose of rocuronium, 2.0 mg.kg-1 sugammadex was administered.
995721|NCT00825786|B3|Baseline|Total|Total of all reporting groups
995722|NCT00825786|B2|Baseline|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995723|NCT00825786|B1|Baseline|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995724|NCT00825786|P2|Participant Flow|Control|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995725|NCT00825786|P1|Participant Flow|Treatment|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995726|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995727|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995728|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995729|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995791|NCT00825500|P3|Participant Flow|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995730|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995731|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995732|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995733|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995734|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995735|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995736|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995737|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995738|NCT00825786|O2|Outcome|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995739|NCT00825786|O1|Outcome|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995740|NCT00825786|E2|Reported Event|Group 2|"sequential group: mepivacaine followed by ropivacaine: syringe 1 containing 15 mL of 1.5% mepivacaine, syringe 2 containing 15 mL of 0.5% ropivacaine (total, 30 mL); syringe 2 was injected with a 90-sec delay after injection of syringe 1.~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995741|NCT00825786|E1|Reported Event|Group 1|"combined group: ropivacaine and mepivacaine mixture: 1:1 volume mixture of 1.5% mepivacaine and 0.5% ropivacaine in 2 syringes (labeled 1 and 2) with 15 mL in each (total, 30 mL) injected in immediate sequence;~Ropivacaine: ropivacaine (15 ml).~Mepivacaine: One syringe will contain mepivacaine (15 ml)"
995742|NCT00825734|B1|Baseline|All Patients|"Patients treated at all dose levels in the Phase I and Phase II portions of the study~: Dose Level 1 (4 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)~Dose Level -1 (3 patients) Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)~Dose Level 1a (76 patients) Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)"
995743|NCT00825734|P3|Participant Flow|Dose Level 1a|Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
995744|NCT00825734|P2|Participant Flow|Dose Level -1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (32mg/m^2)
995745|NCT00825734|P1|Participant Flow|Dose Level 1|Sorafenib PO BID (200mg), Ixabepilone IV every 21 days (40mg/m^2)
995746|NCT00825734|O1|Outcome|Phase II - Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
995747|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
995748|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
995749|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
995750|NCT00825734|O1|Outcome|Sorafenib and Ixabepilone|Oral targeted therapy and Systemic Chemotherapy
995751|NCT00825734|E1|Reported Event|Dose Level 1a|Includes patients treated at the Phase II dose - Sorafenib PO BID (400mg), Ixabepilone IV every 21 days (32mg/m^2)
995752|NCT00825682|B3|Baseline|Total|Total of all reporting groups
995753|NCT00825682|B2|Baseline|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
995754|NCT00825682|B1|Baseline|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
995755|NCT00825682|P2|Participant Flow|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
995756|NCT00825682|P1|Participant Flow|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
995757|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
995758|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
995759|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
995760|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks. Five women did not begin the study and 8 women did not complete reflexology treatments due to personal reasons / inconvenience
995761|NCT00825682|O2|Outcome|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
995762|NCT00825682|O1|Outcome|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
995763|NCT00825682|E2|Reported Event|Control Group|The control group (no intervention,treatment as usual)included 25 breast cancer patients, scheduled for adjunctive radiation treatment, who completed the same questionnaires at the same time points as the as the intervention group.
995764|NCT00825682|E1|Reported Event|Reflexology Group|The experimental group included 47 women with breast cancer scheduled for adjunctive radiation treatment. The women received reflexology treatment initiated at the beginning of radiation therapy, once a week (45 min each), for 10 weeks.
995765|NCT00825630|B5|Baseline|Total|Total of all reporting groups
995766|NCT00825630|B4|Baseline|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
995767|NCT00825630|B3|Baseline|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
995768|NCT00825630|B2|Baseline|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
995769|NCT00825630|B1|Baseline|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
995770|NCT00825630|P4|Participant Flow|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
995771|NCT00825630|P3|Participant Flow|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
995772|NCT00825630|P2|Participant Flow|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
995773|NCT00825630|P1|Participant Flow|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
995774|NCT00825630|O4|Outcome|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
995775|NCT00825630|O3|Outcome|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
995776|NCT00825630|O2|Outcome|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
995777|NCT00825630|O1|Outcome|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
995778|NCT00825630|E4|Reported Event|Esomeprazole (Nexium)|Patients with H.pylori infection will take Esomeprazole orally in the morning (40mg) for 14 days
995779|NCT00825630|E3|Reported Event|Pantoprazole (Controloc)|Patients with H.pylori infection will take Pantoprazole orally in the morning (20mg) for 14 days
995780|NCT00825630|E2|Reported Event|Omeprazole( Losec)|Patients with H.pylori infection will take Omeprazole orally in the morning (30mg) for 14 days
995781|NCT00825630|E1|Reported Event|Lansoprazole (Lanton)|Patients with H.pylori infection will take Lanzoprazole orally in the morning (20 mg) for 14 days
995782|NCT00825565|B1|Baseline|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
995783|NCT00825565|P1|Participant Flow|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
995784|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the target lesion area for assessing the impact on target wound closure.
995785|NCT00825565|O1|Outcome|Allantoin 3% Cream|Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
995786|NCT00825565|E1|Reported Event|Allantoin 3% Cream|This is an open-label study in which all enrolled subjects were assigned to receive the study medication, allantoin 3% cream. Subjects were required to have a diagnosis of Epidermolysis Bullosa (EB). The diagnosis of EB was based on diagnostic immunomapping, electron microscopy, or the principal investigator's judgment based on clear clinical characteristics. Subjects were instructed to apply allantoin 3% cream once daily to the entire body.
995787|NCT00825500|B4|Baseline|Total|Total of all reporting groups
995788|NCT00825500|B3|Baseline|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995789|NCT00825500|B2|Baseline|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995790|NCT00825500|B1|Baseline|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
996068|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
995792|NCT00825500|P2|Participant Flow|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995793|NCT00825500|P1|Participant Flow|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
995794|NCT00825500|O3|Outcome|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995795|NCT00825500|O2|Outcome|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995796|NCT00825500|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
995797|NCT00825500|O3|Outcome|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995798|NCT00825500|O2|Outcome|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995799|NCT00825500|O1|Outcome|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
995800|NCT00825500|E3|Reported Event|Inhaled Loxapine 2.5 mg|"Inhaled Staccato Loxapine 2.5 mg, single dose~Inhaled Loxapine 2.5 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995801|NCT00825500|E2|Reported Event|Inhaled Loxapine 1.25 mg|"Inhaled Staccato Loxapine 1.25 mg, single dose~Inhaled Loxapine 1.25 mg: Inhaled Staccato Loxapine 1.25 mg, single dose"
995802|NCT00825500|E1|Reported Event|Inhaled Placebo|"Inhaled Staccato Placebo (0 mg)~Inhaled Placebo: Inhaled Staccato placebo (0 mg)"
995803|NCT00825344|B3|Baseline|Total|Total of all reporting groups
995804|NCT00825344|B2|Baseline|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
995805|NCT00825344|B1|Baseline|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
995806|NCT00825344|P2|Participant Flow|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
995807|NCT00825344|P1|Participant Flow|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
995808|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
995809|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
995810|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
995811|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
995812|NCT00825344|O2|Outcome|Saline|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
995813|NCT00825344|O1|Outcome|Etanercept|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
995814|NCT00825344|E2|Reported Event|Group 2|"Subcutaneous saline preoperatively~Saline : Given subcutaneously preoperatively"
995815|NCT00825344|E1|Reported Event|Group 1|"Etanercept 50 mg preoperatively~Etanercept : 50 mg subcutaenous preoperatively"
995816|NCT00825318|B1|Baseline|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
995817|NCT00825318|P1|Participant Flow|Daily Ultrafiltration|During the treatment phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
995818|NCT00825318|O3|Outcome|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
995819|NCT00825318|O2|Outcome|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
995820|NCT00825318|O1|Outcome|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
995821|NCT00825318|E3|Reported Event|Return Phase|During the Return phase, patients resumed their prior schedule of three weekly HD and UF sessions for 4 weeks. Systolic and diastolic BPs were measured before and after treatments.
995822|NCT00825318|E2|Reported Event|Daily Ultrafiltration Phase|During the Daily UF phase of the study, the subject will undergo ultrafiltration 6 times a week and hemodialysis 2 times a week.
995823|NCT00825318|E1|Reported Event|Prestudy Phase|During the prestudy phase, baseline 3-month retrospective data were collected for all 13 patients prior to initiation of the daily UF phase.
995824|NCT00825305|B3|Baseline|Total|Total of all reporting groups
995825|NCT00825305|B2|Baseline|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
995826|NCT00825305|B1|Baseline|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
995827|NCT00825305|P2|Participant Flow|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
995828|NCT00825305|P1|Participant Flow|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
995829|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
995830|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
995831|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
995832|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
995833|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
995834|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
995835|NCT00825305|O2|Outcome|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
995836|NCT00825305|O1|Outcome|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
995837|NCT00825305|E2|Reported Event|Conventional Essen(1-1-1-1-1)|Conventional Essen schedule with 1 vaccination on day 0, day 3, day 7, day 14 and day 28, respectively.
995838|NCT00825305|E1|Reported Event|Abbreviated Zagreb (2-1-1)|Abbreviated Zagreb vaccination schedule with 2 vaccinations at day 0, 1 vaccination at day 7 and 1 vaccination at day 21.
995839|NCT00825266|B3|Baseline|Total|Total of all reporting groups
995840|NCT00825266|B2|Baseline|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
995841|NCT00825266|B1|Baseline|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
995842|NCT00825266|P2|Participant Flow|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
995843|NCT00825266|P1|Participant Flow|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg twice daily for 4 weeks, then 125mg BID for duration of study."
995844|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
995845|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
995846|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
995847|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
995848|NCT00825266|O2|Outcome|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
995849|NCT00825266|O1|Outcome|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
995850|NCT00825266|E2|Reported Event|Pioglitazone|"Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration of the study.~Pioglitigone: Pioglitazone 15 mg a day for 4 weeks then Pioglitazone 30 mg a day for the duration fo the study."
995851|NCT00825266|E1|Reported Event|Bosentan|"Bosentan 62.5 twice daily for 4 weeks, then 125 mg twice daily.~bosentan: Bosentan 62.5 mg BID for 4 weeks, then 125mg BID for duration of study."
995852|NCT00825227|B3|Baseline|Total|Total of all reporting groups
995853|NCT00825227|B2|Baseline|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
995854|NCT00825227|B1|Baseline|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
995855|NCT00825227|P2|Participant Flow|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
995856|NCT00825227|P1|Participant Flow|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
995857|NCT00825227|O2|Outcome|Armodafinil 150 mg/Day|"150 mg/day armodafinil (3 tablets of 50 mg armodafinil)~taxane chemotherapy treatment alone or in combination with other agents"
995858|NCT00825227|O1|Outcome|Placebo|"Placebo (3 tablets matching armodafinil tablets)~taxane chemotherapy treatment alone or in combination with other agents"
995859|NCT00825227|E2|Reported Event|Matching Placebo|"placebo~taxane chemotherapy treatment alone or in combination with other agents"
995860|NCT00825227|E1|Reported Event|150 mg/Day Armodafinil|"150 mg/day armodafinil~taxane chemotherapy treatment alone or in combination with other agents"
995861|NCT00825175|B3|Baseline|Total|Total of all reporting groups
995862|NCT00825175|B2|Baseline|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
995863|NCT00825175|B1|Baseline|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
995864|NCT00825175|P2|Participant Flow|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
995865|NCT00825175|P1|Participant Flow|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
995866|NCT00825175|O2|Outcome|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
995867|NCT00825175|O1|Outcome|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
995868|NCT00825175|E2|Reported Event|Treadmill Training and Orthotic Use|This group received treadmill training from the time they could pull to stand until they could take 3 independent steps. They also work supramalleolar foot orthoses for 8 hours a day during that time frame.
995869|NCT00825175|E1|Reported Event|Treadmill Training Only|This group received treadmill training in home for 8 min per day/ 5 days per week. Training started when the children pulled to stand and ended when they could take 3 independent steps.
995870|NCT00825162|B4|Baseline|Total|Total of all reporting groups
995871|NCT00825162|B3|Baseline|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995872|NCT00825162|B2|Baseline|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995873|NCT00825162|B1|Baseline|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995874|NCT00825162|P3|Participant Flow|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995875|NCT00825162|P2|Participant Flow|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995876|NCT00825162|P1|Participant Flow|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995877|NCT00825162|O3|Outcome|Cohort C|
995878|NCT00825162|O2|Outcome|Cohort B|
995879|NCT00825162|O1|Outcome|Cohort A|
995880|NCT00825162|O3|Outcome|Cohort C|
995881|NCT00825162|O2|Outcome|Cohort B|
995882|NCT00825162|O1|Outcome|Cohort A|
995883|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
995884|NCT00825162|O1|Outcome|Cohort C|Participants aged 9 to less than 18 years
995885|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
995886|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
995887|NCT00825162|O2|Outcome|After Second Vaccination, Cohort B|Participants aged 3 Years to Less Than 9 Years
995888|NCT00825162|O1|Outcome|After First Vaccination, Cohort B|Participants aged 3 to less than 9 years
995889|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
995890|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
995891|NCT00825162|O3|Outcome|Cohort C|
995892|NCT00825162|O2|Outcome|Cohort B|
995893|NCT00825162|O1|Outcome|Cohort A|
995894|NCT00825162|O2|Outcome|After Second Vaccination, Cohort A|Participants aged 6 months to less than 3 years
995895|NCT00825162|O1|Outcome|After First Vaccination, Cohort A|Participants aged 6 months to less than 3 years
995896|NCT00825162|E3|Reported Event|Cohort C|Participants aged 9 to less than 18 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995897|NCT00825162|E2|Reported Event|Cohort B|Participants aged 3 to less than 9 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995898|NCT00825162|E1|Reported Event|Cohort A|Participants aged 6 months to less than 3 years, who received one or two doses of the 2009 Southern Hemisphere formulation of CSL Limited Influenza Virus Vaccine.
995899|NCT00824850|B3|Baseline|Total|Total of all reporting groups
995900|NCT00824850|B2|Baseline|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995901|NCT00824850|B1|Baseline|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995902|NCT00824850|P2|Participant Flow|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995903|NCT00824850|P1|Participant Flow|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995904|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995905|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995906|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995907|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995908|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995909|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995910|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995911|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995912|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995913|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995914|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995915|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995916|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995917|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995918|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995919|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995920|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995921|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995922|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995923|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995924|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995925|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995926|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995927|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995928|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995929|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995930|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 4|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995931|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995932|NCT00824850|O2|Outcome|MnCC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995933|NCT00824850|O1|Outcome|MnCC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995934|NCT00824850|O2|Outcome|7vPnC / 13vPnC Postvaccination Visit 5|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995935|NCT00824850|O1|Outcome|7vPnC / 13vPnC Prevaccination Visit 1|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995936|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995937|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995938|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995939|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995940|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995941|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995942|NCT00824850|O2|Outcome|MnCC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.
995943|NCT00824850|O1|Outcome|7vPnC / 13vPnC|13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.
995944|NCT00824850|E2|Reported Event|MnCC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received MnCC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=20; Local reactions N=36; Systemic events N=36."
995945|NCT00824850|E1|Reported Event|7vPnC / 13vPnC|"13vPnC administered as a single 0.5 mL dose IM. Participants had previously received 7vPnC in study D118-P8.~Adverse Events include Local reactions and Systemic events collected on the diary card and reported in the diary-related case report form (systematic assessment) and other Adverse Events collected on the case report form (non-systematic methods).~Other Adverse Events N=22; Local reactions N=38; Systemic events N=38."
995946|NCT00824824|B3|Baseline|Total|Total of all reporting groups
995947|NCT00824824|B2|Baseline|POAG With RVD|7 subjects with POAG were identified to have retinal vascular dysregulation (RVD). We determined whether RVD was present in the following way. The percentage change between the retinal blood flow measured while reclining for 30 min and the baseline retinal blood flow measured while seated was calculated. In a previous study, we found that among healthy subjects the change in the retinal blood flow while reclining compared to sitting was +6.5% ± 12%. For this study, we defined the normal range of blood flow autoregulation as ±2 standard deviations about the mean percentage change found in the control group in our previous study. Subjects with a change in retinal blood flow induced by posture change outside of -17.5% to +35.5% where considered to have RVD.
995948|NCT00824824|B1|Baseline|Primary Open Angle Glaucoma|Subjects of either gender with age range 40 to 80 years old with POAG were eligible for the study. Eligible subjects had a history of an untreated IOP > 21 mmHg in the left eye and a CPSD ≥ 1.0 in this eye. Patients being treated with more than two IOP lowering medications concurrently were excluded. All eligible subjects had open angles on gonioscopy with the filtering portion of the trabecular meshwork visible for 360° in both eyes. All subjects also had at least two reliable Humphrey 24-2 full threshold visual fields that showed reproducible loss in the left eye on tests with fixation loss ≤33%, false positives ≤ 20% and false negatives ≤ 20%. Patients with evidence of exfoliation or pigment dispersion syndrome in either eye were excluded. Subjects with diabetic retinopathy or a history of ocular laser or incisional surgery in either eye were also excluded.
995949|NCT00824824|P2|Participant Flow|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
995996|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
996069|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
997023|NCT00822900|O1|Outcome|Progesterone|
995950|NCT00824824|P1|Participant Flow|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
995951|NCT00824824|O2|Outcome|Brimonidine-Timolol|Post timolol-brimonidine outcome: 6 of the 7 patients were tested following timolol-brimonidine. One of the 7 patients could not be tested due to technical issues. Of the 6 that were tested, 4 patients had retinal vascular autoregulation that was in the normal range. Two patients continued to show RVD.
995952|NCT00824824|O1|Outcome|Dorzolamide-Timolol|Post timolol-dorzolamide outcome: All 7 patients who had RVD following timolol had retinal vascular autoregulation that was in the normal range.
995953|NCT00824824|E2|Reported Event|Brimonidine-Timolol Then Dorzolamide-Timolol|3 of the 7 POAG RVD subjects were ransomized into the brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution. The 3 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 3 subjects were treated with dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution for 6 weeks.After this second 6 week treatment period the same measurements where taken again.
995954|NCT00824824|E1|Reported Event|Dorzolamide-Timolol Then Brimonidine-Timolol|4 of the 7 POAG subjects with RVD were randomized into the dorzolamide hydrochloride 2% - timolol 0.5% ophthalmic solution. The 4 subjects received this treatment for 6 weeks. After the 6-week period the same measurements that were taken at baseline where taken once again. After these measurements were collected these 4 subjects were treated with brimonidine tartrate 0.2%-timolol maleate 0.5% ophthalmic solution for 6 weeks. After this second 6 week period the same measurements that were taken previously were taken again.
995955|NCT00824772|B1|Baseline|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
995956|NCT00824772|P1|Participant Flow|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
995957|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
995958|NCT00824772|O1|Outcome|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
995959|NCT00824772|E1|Reported Event|Gynecologic Patients Undergoing TAH, LAVH|"Inclusion criteria:~19 - 65 years, ASA I,II, total abdominal hysterectomy (TAH) or laparoscopic assisted vaginal hysterectomy (LAVH) under general anesthesia~Exclusion criteria history of cardiovascular, renal, hepatic,neurological,psychological, respiratory disease. sleep apnea, or chronic pain or those taking analgesics, obesity"
995960|NCT00824746|B1|Baseline|Single Arm|Gefitinib retreatment
995961|NCT00824746|P1|Participant Flow|Gefitinib Retreatment Group|Gefitinib retreatment group Patients who were previously treated with gefitinib followed by at least one line of cytotoxic chemotherapy can be enrolled to this retreatment group.
995962|NCT00824746|O1|Outcome|Single Arm|Gefitinib retreatment
995963|NCT00824746|O1|Outcome|Gefitinib Retreatment Group|Gefitinib retreatment
995964|NCT00824746|O1|Outcome|Gefitinib Retreatment Arm|Gefitinib retreatment arm
995965|NCT00824746|E1|Reported Event|Single Arm|Gefitinib retreatment
995966|NCT00824733|B1|Baseline|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
995967|NCT00824733|P1|Participant Flow|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
995997|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
996070|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
997024|NCT00822900|O2|Outcome|Placebo|
995968|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
995969|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
995970|NCT00824733|O1|Outcome|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
995971|NCT00824733|E1|Reported Event|Arm I: Treatment (PF03512676 in Combination With Trastuzumab)|"12 weekly treatments. Week 1-12 patients will receive Trastuzumab 2mg/kg IV(intervenous infusion). Patients who have not been treated wih Trastuzumab within 4 weeks will receive a loading dose of 4 mg/kg on week 1 and PF-03512676-0.16 mg/kg subcutaneous injection.Correlative studies will be drawn on week 1, 2, 6, 12 and 18.~Trastuzumab: IV at 2 mg/kg over 30 minutes on day 1 of each weekly cycle. Patients who have not received trastuzumab for 4 weeks or more will receive a loading dose of 4 mg/kg over 90 minutes day 1 of the first cycle. The dose of trastuzumab will be based on the patient's actual weight at the start of each 4 week treatment cycle.~PF03512676: Patients also receive PF03512676 subcutaneously on days 15 and 22 of course 1 and on days 1, 8, 15, and 22 of all subsequent courses.~Correlative Studies: Blood for performing the correlative studies will be drawn on week 1, 2, 6, 12 and 18."
995972|NCT00824720|B4|Baseline|Total|Total of all reporting groups
995973|NCT00824720|B3|Baseline|Placebo|punctal plug without bimatoprost
995974|NCT00824720|B2|Baseline|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
995975|NCT00824720|B1|Baseline|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
995976|NCT00824720|P3|Participant Flow|Placebo|punctal plug without bimatoprost
995977|NCT00824720|P2|Participant Flow|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
995978|NCT00824720|P1|Participant Flow|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
995979|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
995980|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
995981|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
995982|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
995983|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
995984|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
995985|NCT00824720|O3|Outcome|Placebo|punctal plug without bimatoprost
995986|NCT00824720|O2|Outcome|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
995987|NCT00824720|O1|Outcome|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
995988|NCT00824720|E3|Reported Event|Placebo|punctal plug without bimatoprost
995989|NCT00824720|E2|Reported Event|Low Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, low dose
995990|NCT00824720|E1|Reported Event|High Dose Bimatoprost Punctal Plug|punctal plug with bimatoprost, high dose
995991|NCT00824655|B3|Baseline|Total|Total of all reporting groups
995992|NCT00824655|B2|Baseline|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
995993|NCT00824655|B1|Baseline|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
995994|NCT00824655|P2|Participant Flow|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
995995|NCT00824655|P1|Participant Flow|13vPnC/13vPnC|Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.
996062|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
997025|NCT00822900|O1|Outcome|Progesterone|
995998|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
995999|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
996000|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
996001|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
996002|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
996003|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
996004|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
996005|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
996006|NCT00824655|O2|Outcome|13vPnC|Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
996007|NCT00824655|O1|Outcome|13vPnC/13vPnC|Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.
996008|NCT00824655|E4|Reported Event|13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).
996009|NCT00824655|E3|Reported Event|13vPnC/13vPnC at 12 Months|13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).
996010|NCT00824655|E2|Reported Event|13vPnC/13vPnC at 6 Months of Age|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).
996011|NCT00824655|E1|Reported Event|13vPnC/13vPnC at 5 Months|13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)
996012|NCT00824616|B3|Baseline|Total|Total of all reporting groups
996013|NCT00824616|B2|Baseline|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
996014|NCT00824616|B1|Baseline|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
996015|NCT00824616|P2|Participant Flow|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
996016|NCT00824616|P1|Participant Flow|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
996017|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
996018|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
996019|NCT00824616|O2|Outcome|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
996020|NCT00824616|O1|Outcome|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
996021|NCT00824616|E2|Reported Event|MK-0941|Participants receiving MK-0941 tablets 3 times daily plus insulin injection once daily
996022|NCT00824616|E1|Reported Event|Placebo|Participants receiving Placebo tablets 3 times daily plus insulin injection once daily
996023|NCT00824564|B3|Baseline|Total|Total of all reporting groups
996024|NCT00824564|B2|Baseline|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996025|NCT00824564|B1|Baseline|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996026|NCT00824564|P2|Participant Flow|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996027|NCT00824564|P1|Participant Flow|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996028|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996029|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996030|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996063|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996064|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996031|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996032|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996033|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996034|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996035|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996036|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996037|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996038|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996039|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996040|NCT00824564|O2|Outcome|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996041|NCT00824564|O1|Outcome|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996042|NCT00824564|E2|Reported Event|Standard of Care|Standard of care included the routine surgical and anesthetic techniques being utilized to control blood loss.
996043|NCT00824564|E1|Reported Event|Tranexamic Acid Plus Standard of Care|Tranexamic acid given slowly intravenously (IV) (15 milligram (mg) / kilogram (kg) body weight) 15 minutes before surgery followed by a second dose at 3 hour interval from first dose and third dose at 3 hour interval from the second + Standard of care (included the routine surgical and anesthetic techniques being utilized to control blood loss).
996044|NCT00824538|B1|Baseline|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
996045|NCT00824538|P1|Participant Flow|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
996046|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
996047|NCT00824538|O1|Outcome|Sunitinib|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
996048|NCT00824538|O1|Outcome|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
996049|NCT00824538|E1|Reported Event|Sunitinib (SU)|Eligible pts were treated with SU for 6 months (mo) at 37.5 mg/day. Concomitant hormonal therapy was allowed. Repeat BM aspirations were performed at 6 mo and one year. DTCs were detected by immunomagnetic enrichment + flow cytometry (IE/FC)
996050|NCT00824512|B3|Baseline|Total|Total of all reporting groups
996051|NCT00824512|B2|Baseline|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
996052|NCT00824512|B1|Baseline|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996053|NCT00824512|P2|Participant Flow|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996054|NCT00824512|P1|Participant Flow|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996055|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996056|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996057|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996058|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996059|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996060|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996061|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996065|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996072|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996073|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996074|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996075|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996076|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996077|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996078|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996079|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996080|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996081|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996082|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996083|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996084|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996085|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996086|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996087|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996088|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996089|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996090|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996091|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996092|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996093|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996094|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996095|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996096|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996097|NCT00824512|O2|Outcome|Placebo|Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.
996098|NCT00824512|O1|Outcome|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996099|NCT00824512|E2|Reported Event|Placebo|"Placebo : Placebo 1 tablet BID, orally for 12 to 14 weeks.~Baseline Characteristics data is based on the mITT population, which comprised of the 21 patients. One patient in the placebo group was excluded from the analyses because no assessment of the primary criteria was performed."
996100|NCT00824512|E1|Reported Event|EGb 761® 120 mg|EGb 761 120 mg : EGb 761® 120 mg BID, orally for 12 to 14 weeks
996101|NCT00824473|B3|Baseline|Total|Total of all reporting groups
996102|NCT00824473|B2|Baseline|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996103|NCT00824473|B1|Baseline|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996104|NCT00824473|P2|Participant Flow|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996105|NCT00824473|P1|Participant Flow|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996106|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996107|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996108|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996109|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996110|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996111|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996112|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996113|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996114|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996115|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996116|NCT00824473|O2|Outcome|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996117|NCT00824473|O1|Outcome|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996118|NCT00824473|E2|Reported Event|Astepro 0.15%|0.15% azelastine hydrochloride Nasal Spray/2 sprays per nostril once a day for 14 days
996119|NCT00824473|E1|Reported Event|Placebo|Placebo Nasal Spray/2 sprays per nostril once a day for 14 days
996120|NCT00824460|B7|Baseline|Total|Total of all reporting groups
996121|NCT00824460|B6|Baseline|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
996122|NCT00824460|B5|Baseline|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
996123|NCT00824460|B4|Baseline|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
996124|NCT00824460|B3|Baseline|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
996125|NCT00824460|B2|Baseline|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
996126|NCT00824460|B1|Baseline|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
996127|NCT00824460|P6|Participant Flow|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
996128|NCT00824460|P5|Participant Flow|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
996129|NCT00824460|P4|Participant Flow|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
996133|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g sevelamer hydrochloride (6 tablets)
996134|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
996135|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
996136|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
996137|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
996138|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
996139|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8g sevelamer hydrochloride (6 tablets)
996140|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5g PA21 (10 tablets)
996141|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0g PA21 (8 tablets)
996142|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5g PA21 (6 tablets)
996143|NCT00824460|O2|Outcome|5.0g PA21 (1,000 mg Iron)|Daily dose of 5.0g PA21 (4 tablets)
996144|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25g PA21 (1 tablet)
996145|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
996146|NCT00824460|O5|Outcome|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
996147|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
996148|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
996149|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
996150|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
996151|NCT00824460|O6|Outcome|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
996152|NCT00824460|O5|Outcome|12.5g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
996153|NCT00824460|O4|Outcome|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
996154|NCT00824460|O3|Outcome|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
996155|NCT00824460|O2|Outcome|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
996156|NCT00824460|O1|Outcome|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
996157|NCT00824460|E6|Reported Event|Sevelamer Hydrochloride - Active Control|Daily dose of 4.8 g Sevelamer hydrochloride (6 tablets)
996158|NCT00824460|E5|Reported Event|12.5 g PA21 (2,500 mg Iron)|Daily dose of 12.5 g PA21 (10 tablets)
996159|NCT00824460|E4|Reported Event|10.0 g PA21 (2,000 mg Iron)|Daily dose of 10.0 g PA21 (8 tablets)
996160|NCT00824460|E3|Reported Event|7.5 g PA21 (1,500 mg Iron)|Daily dose of 7.5 g PA21 (6 tablets)
996161|NCT00824460|E2|Reported Event|5.0 g PA21 (1,000 mg Iron)|Daily dose of 5.0 g PA21 (4 tablets)
996162|NCT00824460|E1|Reported Event|1.25 g PA21 (250 mg Iron)|Daily dose of 1.25 g PA21 (1 tablet)
996163|NCT00824434|B1|Baseline|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996164|NCT00824434|P1|Participant Flow|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996165|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996166|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996167|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996168|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996169|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996170|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996171|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996172|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996173|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996174|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996175|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996176|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996177|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996178|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996179|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996180|NCT00824434|O1|Outcome|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996181|NCT00824434|E1|Reported Event|PROMUS Element|Participants who were treated with the PROMUS Element everolimus-eluting stent (investigational device)
996182|NCT00824421|B4|Baseline|Total|Total of all reporting groups
996196|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
997026|NCT00822900|O2|Outcome|Placebo|
996349|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996183|NCT00824421|B3|Baseline|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996184|NCT00824421|B2|Baseline|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996185|NCT00824421|B1|Baseline|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996186|NCT00824421|P3|Participant Flow|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996187|NCT00824421|P2|Participant Flow|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996188|NCT00824421|P1|Participant Flow|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996189|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
996190|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
996191|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
996192|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
996193|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
996194|NCT00824421|O1|Outcome|Lersivirine 500 mg|Participants enrolled in PK substudy received 2 Lersivirine 250 mg tablets and a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
996195|NCT00824421|O2|Outcome|Lersivirine 750 mg|Participants enrolled in PK substudy received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet orally once daily were continued in the evening in PK substudy.
996197|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996198|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996199|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996200|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996201|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996202|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996203|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996204|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996205|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996206|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996207|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996208|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996209|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996210|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996211|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996212|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996213|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996214|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996215|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996216|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996217|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996218|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996219|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996220|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996221|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996222|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996223|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996224|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996225|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996243|NCT00824408|P1|Participant Flow|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996244|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996245|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
997027|NCT00822900|O1|Outcome|Progesterone|
996226|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996227|NCT00824421|O3|Outcome|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996228|NCT00824421|O2|Outcome|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996229|NCT00824421|O1|Outcome|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996230|NCT00824421|E3|Reported Event|Efavirenz 600 mg|Three placebo tablets matched to lersivirine, efavirenz 600 mg tablet orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 placebo tablets matched to lersivirine and efavirenz 600 mg tablet orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. Efavirenz 600 mg tablet, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996231|NCT00824421|E2|Reported Event|Lersivirine 750 mg|Three Lersivirine 250 mg tablets (equivalent to lersivirine 750 mg) and a placebo tablet matched to efavirenz orally once daily along with tenofovir DF 300 mg and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in PK substudy switched to morning dosing regimen, received 3 Lersivirine 250 mg tablets orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996232|NCT00824421|E1|Reported Event|Lersivirine 500 mg|Two lersivirine 250 milligram (mg) tablets (equivalent to lersivirine 500 mg), a placebo tablet matched to lersivirine and a placebo tablet matched to efavirenz orally once daily along with tenofovir disoproxil fumarate (DF) 300 mg tablet and emtricitabine 200 mg tablet orally once daily, in the evening up to 96 weeks. Participants enrolled in pharmacokinetic (PK) substudy switched to lersivirine morning dosing regimen, received 2 Lersivirine 250 mg tablets, a placebo tablet matched to lersivirine orally once daily in the morning for 7 days prior to Week 4, and in the morning and evening on 1 day following Week 4. A placebo tablet matched to efavirenz, tenofovir DF 300 mg tablet and emtricitabine 200 mg tablet were continued in the evening in PK substudy. Evening dosing was continued for the remainder of the study up to Week 96.
996233|NCT00824408|B6|Baseline|Total|Total of all reporting groups
996234|NCT00824408|B5|Baseline|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996235|NCT00824408|B4|Baseline|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996236|NCT00824408|B3|Baseline|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996237|NCT00824408|B2|Baseline|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996238|NCT00824408|B1|Baseline|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996239|NCT00824408|P5|Participant Flow|Randomized Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996240|NCT00824408|P4|Participant Flow|Randomized Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously on day 1 of each 21 day cycle
996241|NCT00824408|P3|Participant Flow|Randomized Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle
996242|NCT00824408|P2|Participant Flow|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996246|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996247|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996248|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996249|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996250|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
996251|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996252|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996253|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
996254|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996255|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996256|NCT00824408|O3|Outcome|Volasertib 300 mg|Patient received Volasertib 300 mg administered intravenously on day 1 of each 21 day cycle.
996257|NCT00824408|O2|Outcome|Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996258|NCT00824408|O1|Outcome|Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996259|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996260|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996261|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996262|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996263|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996264|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996265|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996266|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996267|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996268|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996269|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996270|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996271|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996272|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996273|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996274|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996275|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996276|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996277|NCT00824408|O5|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996278|NCT00824408|O4|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996279|NCT00824408|O3|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996280|NCT00824408|O2|Outcome|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996281|NCT00824408|O1|Outcome|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996282|NCT00824408|O3|Outcome|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996283|NCT00824408|O2|Outcome|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996284|NCT00824408|O1|Outcome|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996285|NCT00824408|E5|Reported Event|Randomization Phase: Pemetrexed 500 mg/m2|Patients received Pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996286|NCT00824408|E4|Reported Event|Randomization Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and Pemetrexed 500 mg/m2 intravenously (i.v.) on day 1 of each 21 day cycle
996287|NCT00824408|E3|Reported Event|Randomization Phase: Volasertib 300 mg|Patients received Volasertib 300 mg administered intravenously (i.v.) on day 1 of each 21 day cycle
996288|NCT00824408|E2|Reported Event|Run-in Phase: Volasertib 300 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 300 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle
996289|NCT00824408|E1|Reported Event|Run-in Phase: Volasertib 250 mg + Pemetrexed 500 mg/m2|Patients received Volasertib 250 mg and pemetrexed 500 mg/m2 administered intravenously (i.v.) on day 1 of each 21 day cycle.
996290|NCT00824382|B5|Baseline|Total|Total of all reporting groups
996291|NCT00824382|B4|Baseline|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996292|NCT00824382|B3|Baseline|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996293|NCT00824382|B2|Baseline|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996294|NCT00824382|B1|Baseline|Placebo|Placebo
996295|NCT00824382|P4|Participant Flow|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996296|NCT00824382|P3|Participant Flow|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996297|NCT00824382|P2|Participant Flow|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996298|NCT00824382|P1|Participant Flow|Placebo|Placebo
996299|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996300|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996301|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996302|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996303|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996304|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996305|NCT00824382|O2|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996306|NCT00824382|O1|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996307|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996308|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996309|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996310|NCT00824382|O1|Outcome|Placebo|Placebo
996311|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996312|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996313|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996314|NCT00824382|O1|Outcome|Placebo|Placebo
996315|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996316|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996317|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996318|NCT00824382|O1|Outcome|Placebo|Placebo
996319|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996320|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996321|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996322|NCT00824382|O1|Outcome|Placebo|Placebo
996323|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996324|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996325|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996326|NCT00824382|O1|Outcome|Placebo|Placebo
996327|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996328|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996329|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996330|NCT00824382|O1|Outcome|Placebo|Placebo
996331|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996332|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996333|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996334|NCT00824382|O1|Outcome|Placebo|Placebo
996335|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996336|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996337|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996338|NCT00824382|O1|Outcome|Placebo|Placebo
996339|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996340|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996341|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996342|NCT00824382|O1|Outcome|Placebo|Placebo
996343|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996344|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996345|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996346|NCT00824382|O1|Outcome|Placebo|Placebo
996347|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996348|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996351|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996352|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996353|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996354|NCT00824382|O1|Outcome|Placebo|Placebo
996355|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996356|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996357|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996358|NCT00824382|O1|Outcome|Placebo|Placebo
996359|NCT00824382|O4|Outcome|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996360|NCT00824382|O3|Outcome|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996361|NCT00824382|O2|Outcome|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996362|NCT00824382|O1|Outcome|Placebo|Placebo
996363|NCT00824382|E4|Reported Event|Olodaterol 10mcg|Olodaterol 10mcg inhalation solution via Respimat
996364|NCT00824382|E3|Reported Event|Olodaterol 5mcg|Olodaterol 5mcg inhalation solution via Respimat
996365|NCT00824382|E2|Reported Event|Olodaterol 2mcg|Olodaterol 2mcg inhalation solution via Respimat
996366|NCT00824382|E1|Reported Event|Placebo|Placebo
996367|NCT00824369|B7|Baseline|Total|Total of all reporting groups
996368|NCT00824369|B6|Baseline|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996369|NCT00824369|B5|Baseline|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996370|NCT00824369|B4|Baseline|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996371|NCT00824369|B3|Baseline|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996372|NCT00824369|B2|Baseline|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996373|NCT00824369|B1|Baseline|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996374|NCT00824369|P6|Participant Flow|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996375|NCT00824369|P5|Participant Flow|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996376|NCT00824369|P4|Participant Flow|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996377|NCT00824369|P3|Participant Flow|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996378|NCT00824369|P2|Participant Flow|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996379|NCT00824369|P1|Participant Flow|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996380|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996381|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996382|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996383|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996384|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996385|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996386|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996387|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996388|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996389|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996390|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996391|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996392|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996393|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996394|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996395|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996396|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996439|NCT00824265|B3|Baseline|Total|Total of all reporting groups
996397|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996398|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996399|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996400|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996401|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996402|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996403|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996404|NCT00824369|O6|Outcome|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996405|NCT00824369|O5|Outcome|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996406|NCT00824369|O4|Outcome|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996407|NCT00824369|O3|Outcome|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996408|NCT00824369|O2|Outcome|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996409|NCT00824369|O1|Outcome|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996410|NCT00824369|E6|Reported Event|Participants From A5271022 - Etravirine 200 mg Arm|Participants who had received etravirine 200 mg twice daily in A5271022 parent study
996411|NCT00824369|E5|Reported Event|Participants From A5271022 - Lersivirine 1000 mg Arm|Participants who had received lersivirine 1000 mg orally once daily in A5271022 parent study
996412|NCT00824369|E4|Reported Event|Participants From A5271022 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271022 parent study
996413|NCT00824369|E3|Reported Event|Participants From A5271015 - Efavirenz 600 mg Arm|Participants who had received efavirenz 600 mg orally once daily in A5271015 parent study
996414|NCT00824369|E2|Reported Event|Participants From A5271015 - Lersivirine 750 mg Arm|Participants who had received lersivirine 750 mg orally once daily in A5271015 parent study
996415|NCT00824369|E1|Reported Event|Participants From A5271015 - Lersivirine 500 mg Arm|Participants who had received lersivirine 500 mg orally once daily in A5271015 parent study
996416|NCT00824291|B3|Baseline|Total|Total of all reporting groups
996417|NCT00824291|B2|Baseline|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996418|NCT00824291|B1|Baseline|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996419|NCT00824291|P2|Participant Flow|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996420|NCT00824291|P1|Participant Flow|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996421|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996422|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996423|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996424|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996425|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996426|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996427|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996428|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996429|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996430|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996431|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996432|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996433|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996434|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996435|NCT00824291|O2|Outcome|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996436|NCT00824291|O1|Outcome|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996437|NCT00824291|E2|Reported Event|Placebo|Participants were administered an oral dose of placebo once daily with or without food.
996438|NCT00824291|E1|Reported Event|DVS SR 50 mg|Participants were administered an oral dose of Desvenlafaxine Succinate Sustained Release (DVS SR) 50 mg tablet once daily with or without food.
996547|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996440|NCT00824265|B2|Baseline|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996441|NCT00824265|B1|Baseline|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996442|NCT00824265|P2|Participant Flow|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996443|NCT00824265|P1|Participant Flow|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996444|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996445|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996446|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996447|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996448|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996449|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996450|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996451|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996452|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996453|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996454|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996455|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996456|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996457|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996458|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996459|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996460|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996461|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996462|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996463|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996464|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996465|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996466|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996467|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996541|NCT00823212|P2|Participant Flow|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996542|NCT00823212|P1|Participant Flow|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996468|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996469|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996470|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996471|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996472|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996473|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996474|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996475|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996476|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996477|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996478|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996479|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996480|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996481|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996543|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996544|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996482|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996483|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996484|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996485|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996486|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996487|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996488|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996489|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996490|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996491|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996492|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996493|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996494|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996495|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996545|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996546|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996496|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996497|NCT00824265|O2|Outcome|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996498|NCT00824265|O1|Outcome|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996499|NCT00824265|E2|Reported Event|Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of fludarabine administered at 25 mg/m^2 and cyclophosphamide administered at 250mg/m^2 on Days 1-3 of each cycle (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996500|NCT00824265|E1|Reported Event|Ofatumumab + Fludarabine + Cyclophosphamide|Participants with relapsed CLL received IV infusions of ofatumumab in combination with fludarabine and cyclophosphamide IV infusions for 6 cycles; each cycle comprised of 28 days. Participants received ofatumumab administered at 300 milligram (mg) on Day 1, 1000 mg on Day 8 of cycle 1 and 1000 mg on Day 1 of cycles 2, 3, 4, 5 and 6. Fludarabine was administered at 25 mg/meter squared [m^2] and cyclophosphamide was administered at 250mg/m^2 on Days 1-3 of each cycles (6 cycles). Participants were followed up one month post therapy and every 3 months for 5 years to evaluate survival and disease status.
996501|NCT00824161|B1|Baseline|TAS-109|TAS-109 2.0 mg/m^2/day
996502|NCT00824161|P1|Participant Flow|TAS-109|TAS-109 2.0 mg/m^2/day
996503|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
996504|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day
996505|NCT00824161|O1|Outcome|TAS-109|TAS-109 2.0 mg/m^2/day Independent Assessment
996506|NCT00824161|E1|Reported Event|TAS-109|TAS-109 2.0 mg/m^2/day
996507|NCT00824070|B4|Baseline|Total|Total of all reporting groups
996508|NCT00824070|B3|Baseline|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
996509|NCT00824070|B2|Baseline|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
996510|NCT00824070|B1|Baseline|Besifloxacin|Besifloxacin ophthalmic suspension
996511|NCT00824070|P3|Participant Flow|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
996512|NCT00824070|P2|Participant Flow|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
996513|NCT00824070|P1|Participant Flow|Besifloxacin|Besifloxacin ophthalmic suspension
996514|NCT00824070|O3|Outcome|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
996515|NCT00824070|O2|Outcome|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
996516|NCT00824070|O1|Outcome|Besifloxacin|Besifloxacin ophthalmic suspension
996517|NCT00824070|E3|Reported Event|Gatifloxacin|Zymar (gatifloxacin ophthalmic solution, 0.3%)
996518|NCT00824070|E2|Reported Event|Moxifloxacin|Vigamox (moxifloxacin ophthalmic solution, 0.5%)
996519|NCT00824070|E1|Reported Event|Besifloxacin|Besifloxacin ophthalmic suspension
996520|NCT00824044|B3|Baseline|Total|Total of all reporting groups
996521|NCT00824044|B2|Baseline|Escitalopram|
996522|NCT00824044|B1|Baseline|Cognitive Behavioral Therapy (CBT)|
996523|NCT00824044|P2|Participant Flow|Escitalopram|
996524|NCT00824044|P1|Participant Flow|Cognitive Behavioral Therapy (CBT)|
996525|NCT00824044|O2|Outcome|Escitalopram|Patients received 10-20 mg/day of flexible-dose open-label escitalopram for 12 weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
996526|NCT00824044|O1|Outcome|Cognitive Behavioral Therapy (CBT)|Patients receive twelve weekly 50-minute individual sessions of cognitive-behavioral therapy over the course of twelve weeks. Scores on the HAM-D-17 at Week 12 are the primary outcome measure.
996527|NCT00824044|E2|Reported Event|Escitalopram|
996528|NCT00824044|E1|Reported Event|Cognitive Behavioral Therapy (CBT)|
996529|NCT00823264|B3|Baseline|Total|Total of all reporting groups
996530|NCT00823264|B2|Baseline|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal by mouth every 4 hours until phenytoin levels are < 25 ug/cc.
996531|NCT00823264|B1|Baseline|Control|Will not receive activated charcoal. Serum levels will be followed.
996532|NCT00823264|P2|Participant Flow|Multiple Doses of Activated Charcoal|Will receive 50 grams of activated charcoal every 4 hours by mouth until phenytoin level is < 25 ug/cc.
996533|NCT00823264|P1|Participant Flow|Control|Will not receive activated charcoal. Serum levels will be followed.
996534|NCT00823264|O2|Outcome|Multiple Doses of Activated Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
996535|NCT00823264|O1|Outcome|Control|Will not receive activated charcoal. Serum levels will be followed.
996536|NCT00823264|E2|Reported Event|Control|Will not receive activated charcoal. Serum levels will be followed.
996537|NCT00823264|E1|Reported Event|Multiple Doses of Charcoal|Patients received 50 grams of activated charcoal by mouth every 6 hours until the phenytoin levels was below 25 ug/cc.
996538|NCT00823212|B3|Baseline|Total|Total of all reporting groups
996539|NCT00823212|B2|Baseline|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996540|NCT00823212|B1|Baseline|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996548|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996549|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996550|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996551|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996552|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996553|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996554|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996555|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996556|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996557|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996558|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996559|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996560|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996561|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996562|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996563|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996564|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996565|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996566|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996567|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996568|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996569|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996570|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996571|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996572|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996573|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996574|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996575|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996576|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996577|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996578|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996579|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996580|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996581|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996582|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996583|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996584|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996585|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996586|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996587|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996588|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996589|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996590|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996591|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996592|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996593|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996594|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
997028|NCT00822900|E2|Reported Event|Placebo|
996595|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996596|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996597|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996598|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996599|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996600|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996601|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996602|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996603|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996604|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996605|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996606|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996607|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996608|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996609|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996610|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996611|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996612|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996613|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996614|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996615|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996616|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996617|NCT00823212|O2|Outcome|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996618|NCT00823212|O1|Outcome|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996619|NCT00823212|O2|Outcome|PROMUS Element|PROMUS Element everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
996620|NCT00823212|O1|Outcome|PROMUS|PROMUS everolimus-eluting stent (EES) implanted using standard percutaneous coronary intervention (PCI) technique
996621|NCT00823212|E2|Reported Event|PROMUS Element|Participants randomized to treatment with PROMUS Element everolimus-eluting stent (investigational device)
996622|NCT00823212|E1|Reported Event|PROMUS|Participants randomized to treatment with PROMUS everolimus-eluting stent (control device)
996623|NCT00823199|B1|Baseline|Group 1|
996624|NCT00823199|P1|Participant Flow|Allopurinal Treatment|
996625|NCT00823199|O1|Outcome|Allopurinal Treatment|
996626|NCT00823199|O1|Outcome|Allopurinal Treatment|
996627|NCT00823199|O1|Outcome|Allopurinal Treatment|
996628|NCT00823199|E1|Reported Event|Group 1|
996629|NCT00824005|B3|Baseline|Total|Total of all reporting groups
996630|NCT00824005|B2|Baseline|Active Stem Cell Injections|Participants will receive active stem cell injections.
996631|NCT00824005|B1|Baseline|Placebo Injections|Participants will receive placebo injections.
996632|NCT00824005|P2|Participant Flow|Active Stem Cell Injections|Participants will receive active stem cell injections.
996633|NCT00824005|P1|Participant Flow|Placebo Injections|Participants will receive placebo injections.
996634|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996635|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996636|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996637|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996638|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996639|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996640|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996641|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996642|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996643|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996644|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996645|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996646|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996647|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996648|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996649|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996650|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996651|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996652|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996653|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996654|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996655|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996656|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996657|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996658|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996659|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996660|NCT00824005|O2|Outcome|Active Stem Cell Injections|Participants received active stem cell injections.
996661|NCT00824005|O1|Outcome|Placebo Injections|Participants received placebo injections.
996662|NCT00824005|E2|Reported Event|Active Stem Cell Injections|Participants received active stem cell injections.
996663|NCT00824005|E1|Reported Event|Placebo Injections|Participants received placebo injections.
996664|NCT00823979|B4|Baseline|Total|Total of all reporting groups
996665|NCT00823979|B3|Baseline|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996666|NCT00823979|B2|Baseline|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996667|NCT00823979|B1|Baseline|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996668|NCT00823979|P3|Participant Flow|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996669|NCT00823979|P2|Participant Flow|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996670|NCT00823979|P1|Participant Flow|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996671|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996672|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996673|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996674|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996675|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996676|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996677|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996678|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996679|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
997029|NCT00822900|E1|Reported Event|Progesterone|
997203|NCT00822185|P2|Participant Flow|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997204|NCT00822185|P1|Participant Flow|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
1040645|NCT00716443|O1|Outcome|Pliaglis® Cream|Pliaglis® Cream
996680|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996681|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996682|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996683|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996684|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996685|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996686|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996687|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996688|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996689|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996690|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996691|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996692|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996693|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996694|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996695|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996696|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996697|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996698|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996699|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
998569|NCT00818766|B3|Baseline|Total|Total of all reporting groups
996700|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996701|NCT00823979|O3|Outcome|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996702|NCT00823979|O2|Outcome|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996703|NCT00823979|O1|Outcome|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996704|NCT00823979|E3|Reported Event|Etravirine 200 mg|Etravirine 100 mg 2 tablets equivalent to etravirine 200 mg, orally twice daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996705|NCT00823979|E2|Reported Event|Lersivirine 1000 mg|Lersivirine (UK-453,061) 250 mg 4 tablets equivalent to lersivirine 1000 mg, orally once daily up to 96 weeks in combination with 1 optimized NRTI as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996706|NCT00823979|E1|Reported Event|Lersivirine 750 mg|Lersivirine (UK-453,061) 250 milligram (mg) 3 tablets equivalent to lersivirine 750 mg and 1 placebo tablet matched to lersivirine 250 mg tablet, orally once daily up to 96 weeks in combination with 1 optimized nucleoside reverse transcriptase inhibitors (NRTI) as per individual prescribing information, darunavir 600 mg tablet orally twice daily and ritonavir 100 mg tablet or capsule orally twice daily.
996707|NCT00823966|B1|Baseline|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
996708|NCT00823966|P1|Participant Flow|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
996709|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
996710|NCT00823966|O1|Outcome|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
996711|NCT00823966|E1|Reported Event|Delavirdine Mesilate|"RESCRIPTOR® TABLETS 200mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 400mg of Delavirdine Mesilate administered orally 3 times daily.This drug must always be administered in combination with other anti-human immunodeficiency virus (HIV) drugs."
996712|NCT00823901|B3|Baseline|Total|Total of all reporting groups
996713|NCT00823901|B2|Baseline|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
996714|NCT00823901|B1|Baseline|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
996715|NCT00823901|P2|Participant Flow|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
996716|NCT00823901|P1|Participant Flow|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
996717|NCT00823901|O2|Outcome|Placebo|Participants applied placebo gel without active ingredient on entire face (forehead, nose, cheek, chin)once daily at night for 12 weeks
996718|NCT00823901|O1|Outcome|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
996719|NCT00823901|E2|Reported Event|Placebo Gel|Participants applied Placebo vehicle gel (with out active ingredient) on entire face (forehead, nose, cheek, chin) once daily at night for 12 weeks
996720|NCT00823901|E1|Reported Event|Clindamycin/Tretinoin Gel|Participants applied Clindamycin Phosphate 1.2% And Tretinoin 0.025% Gel on entire face (forehead, nose, cheeks, chin) once daily at night for 12 weeks
996721|NCT00823836|B3|Baseline|Total|Total of all reporting groups
996722|NCT00823836|B2|Baseline|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
999108|NCT00817479|B3|Baseline|Total|Total of all reporting groups
996723|NCT00823836|B1|Baseline|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996724|NCT00823836|P2|Participant Flow|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996725|NCT00823836|P1|Participant Flow|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996726|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996727|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996728|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996729|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996730|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996854|NCT00823719|B2|Baseline|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996731|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996732|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996733|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996734|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996735|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996736|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996737|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996738|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996855|NCT00823719|B1|Baseline|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996739|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996740|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996741|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996742|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996743|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996744|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996745|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996746|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996856|NCT00823719|P2|Participant Flow|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
997291|NCT00821873|E1|Reported Event|Adverse Events|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
996747|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996748|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996749|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996750|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996751|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996752|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996753|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996754|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996755|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996756|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996757|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996758|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996759|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996760|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996761|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996762|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996763|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996764|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996765|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996766|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996767|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996768|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996769|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996770|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996771|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996772|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996773|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996774|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996775|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996776|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996777|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996778|NCT00823836|O1|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996779|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996780|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996781|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996782|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996783|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996784|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996785|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996786|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996787|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996788|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996789|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996790|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996791|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996792|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996793|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996794|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996795|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996796|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996797|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996798|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996799|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996800|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996801|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996802|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996803|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996804|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996805|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996806|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996807|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996808|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996809|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996810|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996811|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996812|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996813|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996814|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996815|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996816|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996817|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996818|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996819|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996820|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996821|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996822|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996823|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996824|NCT00823836|O2|Outcome|Ropinirole IR-Ropinirole PR|Participants received ropinirole immediate release (IR) tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996825|NCT00823836|O1|Outcome|Ropinirole PR-Ropinirole PR|Participants received ropinirole prolonged release/extended release (PR/XR) tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 milligram (mg) PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996826|NCT00823836|E2|Reported Event|Ropinirole IR-Ropinirole PR|Participants received ropinirole IR tablets three times daily at the initial dose of 0.75 mg/day with a weekly dose increase to 3 mg/day at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 15 mg/day. Ropinirole IR tablets were administered until the night of the Week 24 visit and were replaced by ropinirole PR/XR tablets on the following morning, the morning of the first day of the PR/XR Switching Phase, at the same dose level. Participants who entered the Long-term Phase continued to receive ropinirole PR/XR until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter into the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996857|NCT00823719|P1|Participant Flow|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996827|NCT00823836|E1|Reported Event|Ropinirole PR-Ropinirole PR|Participants received ropinirole PR/XR tablets orally once daily. Participants firstly received matching PR/XR placebo tablets for 2 weeks and then received 2 mg PR/XR tablets with a weekly dose increase to 4 mg at Week 4. Between Weeks 6 and 24, the dose was optionally increased at intervals of 2 weeks or longer up to 16 mg/day. In the PR/XR Switching Phase, administration of the PR/XR tablets was continued until Week 32 at the same dose level as that at the end of the Non-Inferiority Verification Phase. Participants who entered into the Long-term Phase continued to receive ropinirole PR/XR tablets until Week 54 at the same dose level as that at the end of the PR/XR Switching Phase. Participants who did not enter the Long-term Phase entered the Down-titration Phase after completion of the PR/XR Switching Phase.
996828|NCT00823823|B3|Baseline|Total|Total of all reporting groups
996829|NCT00823823|B2|Baseline|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
996830|NCT00823823|B1|Baseline|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
996831|NCT00823823|P2|Participant Flow|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
996832|NCT00823823|P1|Participant Flow|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
996833|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
996834|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
996835|NCT00823823|O2|Outcome|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
996836|NCT00823823|O1|Outcome|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
996837|NCT00823823|E2|Reported Event|Circumferential Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a circumferential cast
996838|NCT00823823|E1|Reported Event|Bivalved Cast|Patients with a displaced distal radius or mid-diaphyseal forearm fracture requiring closed reduction will be immobilized in a bivalved cast
996839|NCT00823797|B3|Baseline|Total|Total of all reporting groups
996840|NCT00823797|B2|Baseline|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996841|NCT00823797|B1|Baseline|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996842|NCT00823797|P2|Participant Flow|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996843|NCT00823797|P1|Participant Flow|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996844|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996845|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996846|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996847|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996848|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996849|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996850|NCT00823797|O2|Outcome|Treatment (Bendamustine Hydrochloride) for Anaplastic Glioma|"Anaplastic Glioma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996851|NCT00823797|O1|Outcome|Treatment (Bendamustine Hydrochloride) for Glioblastoma|"Glioblastoma Arm~Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity."
996852|NCT00823797|E1|Reported Event|Treatment (Bendamustine Hydrochloride)|"Patients receive bendamustine hydrochloride IV over 30-90 minutes on days 1-2. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~Bendamustine Hydrochloride: Given IV~Quality-of-Life Assessment: Ancillary studies"
996853|NCT00823719|B3|Baseline|Total|Total of all reporting groups
996987|NCT00823043|B1|Baseline|Total Subject Population|All subjects responding to survey
997292|NCT00821821|B4|Baseline|Total|Total of all reporting groups
996858|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996859|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996860|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996861|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996862|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996863|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996864|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996865|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996866|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996867|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996868|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996869|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996870|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996871|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996872|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996873|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996874|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996875|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996876|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996877|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996988|NCT00823043|P2|Participant Flow|Timolol Maleate in Sorbate|Timolol maleate in sorbate 0.5% ophthalmic solution
999109|NCT00817479|B2|Baseline|Dexamethasone|20 mg dexamethasone IV push
996878|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996879|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996880|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996881|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996882|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996883|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996884|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996885|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996886|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996887|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996989|NCT00823043|P1|Participant Flow|Timolol Hemihydrate|Timolol hemihydrate 0.5% ophthalmic solution.
996888|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996889|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996890|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996891|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996892|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996893|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996894|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996895|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996896|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996897|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996898|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996899|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996900|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996901|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996902|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996903|NCT00823719|O3|Outcome|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996904|NCT00823719|O2|Outcome|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996905|NCT00823719|O1|Outcome|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996906|NCT00823719|E3|Reported Event|Total Ofatumumab + Chemotherapy|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy (either DHAP or ICE). Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. DHAP contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/m^2/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 g/m^2 over 3 hr every 12 hr (2 doses) for each infusion on Day 2 of each cycle. ICE contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996907|NCT00823719|E2|Reported Event|Ofatumumab + ICE|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 mg) was IV infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The ICE (ifosfamide, carboplatin, etoposide) regimen (salvage chemotherapy) contained: etoposide (100 mg/m^2/day) administered IV on Days 1, 2, and 3 of each cycle; carboplatin (up to 800 mg) on Day 2 of each cycle; and ifosfamide plus mesna, both at 5 g/m^2/day as an IV continuous infusion on Day 2 of each cycle.
996990|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
996991|NCT00823043|O1|Outcome|Timolol Hemihydrate|
996992|NCT00823043|O2|Outcome|Timolol Maleate in Sorbate|
996908|NCT00823719|E1|Reported Event|Ofatumumab + DHAP|Participants received 3 cycles (21 days per each cycle) of ofatumumab combined with salvage chemotherapy. Ofatumumab (1000 milligrams [mg]) was intravenously (IV) infused on Day 1 (or up to 3 days prior to Day 1) and Day 8 (+/-2 days) of Cycle 1 of the salvage chemotherapy, and then on Day 1 only of Cycles 2 and 3. The DHAP (dexamethasone, cytarabine, cisplatin) regimen (salvage chemotherapy) contained: dexamethasone (40 mg/day) administered orally or IV on Days 1, 2, 3, or 4 of each cycle; cisplatin (100 mg/square meter [m^2]/day) as an IV continuous infusion on Day 1 of each cycle; and cytarabine 2 gram (g)/m^2 over 3 hours (hr) every 12 hr (2 doses) for each infusion on Day 2 of each cycle.
996909|NCT00823615|B1|Baseline|Overall|This reporting group includes all enrolled and dispensed subjects
996910|NCT00823615|P2|Participant Flow|Senofilcon A / Lotrafilcon B|Senofilcon A multifocal contact lens worn first, followed by Lotrafilcon B multifocal contact lens worn second. Both products were worn on a daily-wear basis.
996911|NCT00823615|P1|Participant Flow|Lotrafilcon B / Senofilcon A|Lotrafilcon B multifocal contact lens worn first, followed by Senofilcon A multifocal contact lens worn second. Both products were worn on a daily-wear basis.
996912|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
996913|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
996914|NCT00823615|O2|Outcome|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
996915|NCT00823615|O1|Outcome|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
996916|NCT00823615|E2|Reported Event|Senofilcon A Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
996917|NCT00823615|E1|Reported Event|Lotrafilcon B Multifocal Contact Lens|Silicone hydrogel, soft, multifocal contact lens
996918|NCT00823472|B3|Baseline|Total|Total of all reporting groups
996919|NCT00823472|B2|Baseline|Start rFSH on Cycle Day 5|
996920|NCT00823472|B1|Baseline|Start rFSH Cycle Day 2|
996921|NCT00823472|P2|Participant Flow|Start rFSH on Cycle Day 5|
996922|NCT00823472|P1|Participant Flow|Start rFSH Cycle Day 2|
996923|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
996924|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
996925|NCT00823472|O2|Outcome|Start rFSH on Cycle Day 5|
996926|NCT00823472|O1|Outcome|Start rFSH Cycle Day 2|
996927|NCT00823472|E2|Reported Event|Start rFSH on Cycle Day 5|
996928|NCT00823472|E1|Reported Event|Start rFSH Cycle Day 2|
996929|NCT00823303|B3|Baseline|Total|Total of all reporting groups
996930|NCT00823303|B2|Baseline|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
996931|NCT00823303|B1|Baseline|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
996932|NCT00823303|P2|Participant Flow|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
996933|NCT00823303|P1|Participant Flow|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
996934|NCT00823303|O2|Outcome|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
996935|NCT00823303|O1|Outcome|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
996936|NCT00823303|E2|Reported Event|Calcitriol|"titrated to achieve 40-60% PTH suppression~Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression"
996937|NCT00823303|E1|Reported Event|Paricalcitol|"titrated to achieve 40-60% PTH suppression~Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression"
996938|NCT00823095|B1|Baseline|Group 1|Treatment
996939|NCT00823095|P1|Participant Flow|Topically Applied Nitric Oxide|Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.
996940|NCT00823095|O1|Outcome|Treatment|reduction in bioburden as assessed by number of cfu's per cm2 on culture
996941|NCT00823095|O1|Outcome|Group 1|Treatment
996942|NCT00823095|E1|Reported Event|Group 1|Treatment
996943|NCT00823082|B3|Baseline|Total|Total of all reporting groups
996944|NCT00823082|B2|Baseline|Control Group|No preoperative ATIII supplementation administered
996945|NCT00823082|B1|Baseline|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996946|NCT00823082|P2|Participant Flow|Control Group|No preoperative ATIII supplementation administered
996947|NCT00823082|P1|Participant Flow|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996948|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996949|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996950|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996951|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996952|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996953|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996954|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996955|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996956|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996957|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996958|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996959|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996960|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996961|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996962|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996963|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996964|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996965|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996966|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996967|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996968|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996969|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996970|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996971|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996972|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996973|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996974|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996975|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996976|NCT00823082|O2|Outcome|Control Group|No preoperative ATIII supplementation administered
996977|NCT00823082|O1|Outcome|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996978|NCT00823082|E2|Reported Event|Control Group|No preoperative ATII supplementation administered
996979|NCT00823082|E1|Reported Event|Antithrombin III Treatment Group|"Preoperative ATIII supplementation administered immediately after anesthesia induction~Antithrombin III: Single dose of antithrombin III sufficient to achieve a preoperative level of 120%"
996980|NCT00823069|B1|Baseline|Perlane and Perlane-L|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
996981|NCT00823069|P1|Participant Flow|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
996982|NCT00823069|O2|Outcome|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
996983|NCT00823069|O1|Outcome|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
996984|NCT00823069|O1|Outcome|Perlane-L and Perlane|Split face design with each subject receiveing Perlane on one side of the face and Perlane-L on the other.
996985|NCT00823069|E2|Reported Event|Perlane|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
996986|NCT00823069|E1|Reported Event|Perlane-L|Split face design with each subject receiving Perlane on one side of the face and Perlane-L on the other. After treatments the patient scores pain experienced on a 2 VAS scales. One VAS represents pain on the left side of face, and the other VAS for the right side of the face. Least pain on VAS is at the 0 mm mark, and worst pain is at the 100 mm mark. Objective is to calculate the proportion of subjects that had a within-subject difference in the VAS (Perlane minus Perlan-L) of at least 10 mm at injection together with a 95% confidence interval. The objective was to show that the confidence interval lay above 50%.
997030|NCT00822770|B1|Baseline|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
997031|NCT00822770|P1|Participant Flow|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~Thymoglobulin (ATG) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
997032|NCT00822770|O1|Outcome|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
997033|NCT00822770|E1|Reported Event|Plerixafor + G-CSF|"ATG + Plerixafor (AMD3100) + G-CSF (Filgrastim) + Fludarabine + Busulfan + Allogeneic blood stem cell transplant~Allogeneic blood stem cell transplant : Stem Cell Infusion (Bone marrow or PBPC)~Filgrastim : Dose of 10 mcg/kg subcutaneous injection beginning on day -9 daily for 6 days.~Fludarabine : Dose of 40 mg/m^2 beginning on Day -6 for four consecutive days.~ATG (Thymoglobulin) : Dose(s) of 0.5 mg/kg on day -3; of 1.5 mg/kg on day -2; and of 2 mg/kg on day -1. Given only to patients with unrelated donors.~Busulfan : Dose of 130 mg/m^2 for four consecutive days, immediately after completion of Fludarabine.~Plerixafor : Phase I: Starting dose of 0 (escalating doses 80, 160, 240 mcg/kg) given daily subcutaneously in abdomen for 4 doses.~Phase II: Maximum Tolerated Dose (MTD) as determined in Phase I"
997034|NCT00822757|B3|Baseline|Total|Total of all reporting groups
997035|NCT00822757|B2|Baseline|Placebo|Saline placebo single dose at baseline.
997036|NCT00822757|B1|Baseline|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
997037|NCT00822757|P2|Participant Flow|Placebo|Saline placebo single dose at baseline.
997038|NCT00822757|P1|Participant Flow|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
997039|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
997040|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
997041|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
997042|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
997043|NCT00822757|O2|Outcome|Placebo|Saline placebo single dose at baseline.
997044|NCT00822757|O1|Outcome|V710 (60 mcg) Lyophilized|V710 (60 mcg) single dose at baseline.
997045|NCT00822757|E2|Reported Event|Placebo|Saline placebo single dose at baseline.
997046|NCT00822757|E1|Reported Event|V710 (60 mcg) Lyophilized|V710 (60 mcg)single dose at baseline.
997047|NCT00822692|B3|Baseline|Total|Total of all reporting groups
997048|NCT00822692|B2|Baseline|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
997049|NCT00822692|B1|Baseline|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
997050|NCT00822692|P2|Participant Flow|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
997051|NCT00822692|P1|Participant Flow|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
997052|NCT00822692|O2|Outcome|Matched Placebo 2 Pills PO BID x 7 Days|Placebo arm
997053|NCT00822692|O1|Outcome|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|Active Intervention Arm
997054|NCT00822692|E2|Reported Event|Matched Placebo 2 Pills PO BID x 7 Days|matched placebo 2 pills PO BID x 7 days
997055|NCT00822692|E1|Reported Event|Bactrim DS (800/160) Two Tablets PO BID x 7 Days|bactrim DS (800/160) two tablets PO BID x 7 days
997056|NCT00822679|B3|Baseline|Total|Total of all reporting groups
997057|NCT00822679|B2|Baseline|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
997058|NCT00822679|B1|Baseline|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
997059|NCT00822679|P2|Participant Flow|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
997060|NCT00822679|P1|Participant Flow|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
997061|NCT00822679|O2|Outcome|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
997202|NCT00822185|P3|Participant Flow|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
999110|NCT00817479|B1|Baseline|Placebo|Placebo [saline]
997062|NCT00822679|O1|Outcome|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
997063|NCT00822679|E2|Reported Event|2: Placebo|"Subjects given placebo for 3 consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Placebo: Subjects are given placebo for 3 consecutive nights"
997064|NCT00822679|E1|Reported Event|1: Eszopiclone|"Subjects receive Eszopiclone for three consecutive nights to observe changes in sleep measures, and inflammatory and coagulation factors~Eszopiclone: Subject receives Eszopiclone for 3 consecutive nights. 3 mg orally at bedtime for patients age 64 and under, and 2 mg QHS for patients age 65 and older."
997065|NCT00822588|B3|Baseline|Total|Total of all reporting groups
997066|NCT00822588|B2|Baseline|No Sangvia|No autologous blood transfusion.
997067|NCT00822588|B1|Baseline|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
997068|NCT00822588|P2|Participant Flow|No Sangvia|No autologous blood transfusion.
997069|NCT00822588|P1|Participant Flow|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
997070|NCT00822588|O2|Outcome|No Sangvia|No autologous blood transfusion.
997071|NCT00822588|O1|Outcome|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
997072|NCT00822588|E2|Reported Event|No Sangvia|No autologous blood transfusion.
997073|NCT00822588|E1|Reported Event|Sangvia|Autologous blood transfusion with Sangvia device (routinely)
997074|NCT00822523|B4|Baseline|Total|Total of all reporting groups
997075|NCT00822523|B3|Baseline|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997076|NCT00822523|B2|Baseline|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
997077|NCT00822523|B1|Baseline|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997078|NCT00822523|P3|Participant Flow|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997079|NCT00822523|P2|Participant Flow|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
997080|NCT00822523|P1|Participant Flow|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997081|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997082|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997083|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997084|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997085|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997086|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997087|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997088|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997089|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997090|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
999113|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
997091|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997092|NCT00822523|O1|Outcome|"CMAP (Inactive) With Botulinum Toxin Type A, 20 Units"|"Compound muscle action potential (CMAP) with reference electrode in an inactive location at the ipsilateral medial malleolus~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997093|NCT00822523|O2|Outcome|Surface EMG MRV-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997094|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997095|NCT00822523|O2|Outcome|Surface EMG MRV-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997096|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997097|NCT00822523|O2|Outcome|Surface EMG MRV-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the MRV (Mean Rectified Voltage) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997098|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997099|NCT00822523|O2|Outcome|Surface EMG RMS-200 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 200 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997100|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997101|NCT00822523|O2|Outcome|Surface EMG RMS-500 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 500 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997102|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997103|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997104|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
997105|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997106|NCT00822523|O2|Outcome|Surface EMG RMS-1000 With Botulinum Toxin Type A, 20 Units|"Surface Electromyography (Surface EMG) measured as the RMS (Root Mean Squared) with 1000 ms interval~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997107|NCT00822523|O1|Outcome|CMAP (Standard) With Botulinum Toxin Type A, 20 Units|"Compound muscle action potential (CMAP) with reference electrode in the standard location at the base of the ipsilateral 5th toe~Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997108|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997109|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
997110|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997111|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997112|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
999114|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
997113|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997114|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997115|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
997116|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997117|NCT00822523|O3|Outcome|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997118|NCT00822523|O2|Outcome|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
997119|NCT00822523|O1|Outcome|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997120|NCT00822523|E3|Reported Event|Placebo|"Saline, Single dose, Intramuscular injection into right EDB~Saline: Single Dose, Intramuscular into right EDB muscle"
997121|NCT00822523|E2|Reported Event|Botulinum Toxin, Type A, 2 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 2 units~Botulinum Toxin, Type A: 2 units, single dose, intramuscular to right EDB muscle"
997122|NCT00822523|E1|Reported Event|Botulinum Toxin Type A, 20 Units|"Single intramuscular (into extensor digitorum brevis muscle of the foot) dose of Botulinum toxin type A, 20 units~Botulinum Toxin, Type A: 20 units, single dose, intramuscular in right EDB muscle"
997123|NCT00822510|B3|Baseline|Total|Total of all reporting groups
997124|NCT00822510|B2|Baseline|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997125|NCT00822510|B1|Baseline|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997126|NCT00822510|P2|Participant Flow|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997127|NCT00822510|P1|Participant Flow|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997128|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997129|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997130|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997131|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997132|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997133|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997134|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997135|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997136|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997137|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997138|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only. Educational topics included prostate cancer health, side effects, physical activity, diet. Participants were called on the telephone each week for about 30 minutes.~Telephone delivered education only: Telephone delivered 8 week educational intervention on prostate cancer health, side effects, physical activity, diet, smoking cessation"
997139|NCT00822510|O1|Outcome|Telephone Interpersonal Counseling|"Telephone delivered interpersonal counseling support intervention. Intervention was for 8 weeks. Participants were called on the telephone each week for about 30 minutes.~Telephone Interpersonal Counseling: Telephone delivered 8 week education and counseling intervention based on interpersonal psychotherapy."
997140|NCT00822510|O2|Outcome|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997141|NCT00822510|O1|Outcome|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997142|NCT00822510|E2|Reported Event|Telephone Delivered Education Only|"Telephone delivered education only for 8 weeks~Telephone delivered education only: Telephone delivered education for 8 weeks"
997143|NCT00822510|E1|Reported Event|Telephone Delivered Interpersonal Counseling|"Telephone delivered education and support for 8 weeks~Telephone Interpersonal Counselling Intervention: Telephone delivered 8 week education and support intervention"
997144|NCT00822354|B3|Baseline|Total|Total of all reporting groups
997145|NCT00822354|B2|Baseline|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
997146|NCT00822354|B1|Baseline|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
997147|NCT00822354|P2|Participant Flow|Placebo Followed by Tadalafil|Subjects received placebo every other day for four weeks, followed by tadalafil 20 mg every other day for four weeks. A one week washout occurred between the placebo and treatment periods.
997148|NCT00822354|P1|Participant Flow|Tadalafil Followed by Placebo|Subjects received tadalafil 20 mg every other day for four weeks followed by placebo every other day for four weeks. A one week washout occurred between the treatment and placebo periods.
997149|NCT00822354|O4|Outcome|Week 4 of Placebo|
997150|NCT00822354|O3|Outcome|Pre-placebo|
997151|NCT00822354|O2|Outcome|Week 4 of Treatment|
997152|NCT00822354|O1|Outcome|Pre-treatment|
997153|NCT00822354|O4|Outcome|Week 4 of Placebo|
997154|NCT00822354|O3|Outcome|Pre-placebo|
997155|NCT00822354|O2|Outcome|Week 4 of Treatment|
997156|NCT00822354|O1|Outcome|Pre-treatment|
997157|NCT00822354|O4|Outcome|Week 4 of Placebo|
997158|NCT00822354|O3|Outcome|Pre-placebo|
997159|NCT00822354|O2|Outcome|Week 4 of Treatment|
997160|NCT00822354|O1|Outcome|Pre-treatment|
997161|NCT00822354|O4|Outcome|Week 4 of Placebo|
997162|NCT00822354|O3|Outcome|Pre-placebo|
997163|NCT00822354|O2|Outcome|Week 4 of Treatment|
997164|NCT00822354|O1|Outcome|Pre-treatment|
997165|NCT00822354|O4|Outcome|Week 4 of Placebo|
997166|NCT00822354|O3|Outcome|Pre-placebo|
997167|NCT00822354|O2|Outcome|Week 4 of Treatment|
997168|NCT00822354|O1|Outcome|Pre-treatment|
997169|NCT00822354|O4|Outcome|Week 4 of Placebo|
997170|NCT00822354|O3|Outcome|Pre-placebo|
997171|NCT00822354|O2|Outcome|Week 4 of Treatment|
997172|NCT00822354|O1|Outcome|Pre-treatment|
997173|NCT00822354|E2|Reported Event|Placebo|Subjects received placebo every other day for four weeks
997174|NCT00822354|E1|Reported Event|Tadalafil|Subjects received tadalafil 20 mg every other day for four weeks.
997175|NCT00822328|B3|Baseline|Total|Total of all reporting groups
997176|NCT00822328|B2|Baseline|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
997177|NCT00822328|B1|Baseline|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
997178|NCT00822328|P2|Participant Flow|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
997179|NCT00822328|P1|Participant Flow|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
997180|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
997181|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
997182|NCT00822328|O2|Outcome|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
997183|NCT00822328|O1|Outcome|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
997184|NCT00822328|E2|Reported Event|Unfermented Milk (Placebo Group)|Unfermented milk without Lactobacillus casei strain Shirota 100ml per day
997185|NCT00822328|E1|Reported Event|Fermented Milk (Study Group)|Fermented milk with Lactobacillus casei strain Shirota 100ml per day
997186|NCT00822237|B3|Baseline|Total|Total of all reporting groups
997187|NCT00822237|B2|Baseline|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
997188|NCT00822237|B1|Baseline|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
997189|NCT00822237|P2|Participant Flow|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
997190|NCT00822237|P1|Participant Flow|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
997191|NCT00822237|O1|Outcome|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by injection ~6 weeks apart"
997192|NCT00822237|E2|Reported Event|VARIVAX 1999 Process + M-M-R II|"VARIVAX (1999 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
997193|NCT00822237|E1|Reported Event|VARIVAX 2007 Process + M-M-R II|"VARIVAX (2007 process) in two 0.5 mL doses by injection ~6 weeks apart~M-M-R II (Measles, Mumps, and Rubella Virus Vaccine Live) in two 0.5 mL doses by~injection ~6 weeks apart"
997194|NCT00822185|B6|Baseline|Total|Total of all reporting groups
997195|NCT00822185|B5|Baseline|Placebo|A single dose of placebo was administered intravenously
997196|NCT00822185|B4|Baseline|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997197|NCT00822185|B3|Baseline|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997198|NCT00822185|B2|Baseline|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997199|NCT00822185|B1|Baseline|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997200|NCT00822185|P5|Participant Flow|Placebo|A single dose of placebo was administered intravenously
997201|NCT00822185|P4|Participant Flow|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997205|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997206|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997207|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997208|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997209|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997210|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997211|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997212|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997213|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997214|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997215|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997216|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997217|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997218|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997219|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997220|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997221|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997222|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997223|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997224|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997225|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997226|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997227|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997228|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997229|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997230|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997231|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997232|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997233|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997234|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997235|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997236|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997237|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997238|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997239|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997240|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997241|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997242|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997243|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997244|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997245|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997246|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997247|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997248|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997249|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997250|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997251|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997252|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997253|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
997254|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997255|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997256|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997257|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997258|NCT00822185|O5|Outcome|Placebo|A single dose of placebo was administered intravenously
997259|NCT00822185|O4|Outcome|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997260|NCT00822185|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997261|NCT00822185|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997262|NCT00822185|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997263|NCT00822185|E5|Reported Event|Placebo|A single dose of placebo was administered intravenously
997264|NCT00822185|E4|Reported Event|Vatreptacog Alfa 30 mcg/kg|A single dose of Vatreptacog alfa 30 mcg/kg bodyweight was administered intravenously
997265|NCT00822185|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|A single dose of Vatreptacog alfa 20 mcg/kg bodyweight was administered intravenously
997266|NCT00822185|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|A single dose of Vatreptacog alfa 10 mcg/kg bodyweight was administered intravenously
997267|NCT00822185|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|A single dose of Vatreptacog alfa 5 mcg/kg bodyweight was administered intravenously
997268|NCT00822172|B3|Baseline|Total|Total of all reporting groups
997269|NCT00822172|B2|Baseline|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997270|NCT00822172|B1|Baseline|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997271|NCT00822172|P2|Participant Flow|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997272|NCT00822172|P1|Participant Flow|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997273|NCT00822172|O2|Outcome|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997274|NCT00822172|O1|Outcome|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997275|NCT00822172|E2|Reported Event|Cilostazol + Placebo|"cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997276|NCT00822172|E1|Reported Event|Cilostazol + L-Carnitine|"Levocarnitine tartrate : Capsule form, 1,002 mg (3 capsules) taken by mouth two times per day (morning and evening). L-carnitine will be taken from Day 0 to Day 180.~cilostazol : Background therapy beginning at 50mg (1 pill) taken by mouth two times per day for two to three weeks. Then 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for one to two weeks.~Randomized therapy will consist of 100 mg (1 pill) to be taken by mouth two times per day (morning and evening) for approximately 180 days."
997277|NCT00821951|B1|Baseline|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
997278|NCT00821951|P1|Participant Flow|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
997293|NCT00821821|B3|Baseline|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
997294|NCT00821821|B2|Baseline|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
997279|NCT00821951|O1|Outcome|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
997280|NCT00821951|E1|Reported Event|Vorinostat and Radiotherapy|"Vorinostat : 200 mg, 300 mg, 400 mg, once per RT fraction~Radiotherapy : Standard fractionation of 3.0 Gy per day over 2 weeks, to a total dose of 30 Gy, will be utilized for all patients. All patients will be treated one time per day, 5 days per week unless interruption is clinically indicated."
997281|NCT00821886|B1|Baseline|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
997282|NCT00821886|P1|Participant Flow|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
997283|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
997284|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
997285|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
997286|NCT00821886|O1|Outcome|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
997287|NCT00821886|E1|Reported Event|Ixabepilone/Trastuzumab/Carboplatin|"Neoadjuvant treatment with Ixabepilone, Trastuzumab and Carboplatin, followed by surgery, peri-operative treatment and post-operative (adjuvant) treatment if patient deemed to be a surgical candidate~Ixabepilone: Ixabepilone 40mg/m2 IV infusion over 3 hours on day 1 of cycles 1-6 (all treatment cycles are 21 days in length)~Trastuzumab: Trastuzumab 8mg/kg IV over 90 minutes for the first infusion (Cycle 1, Day 1) with a 60 minute post-infusion observation period. Subsequent infusions (Day 1 of Cycles 2-6 with all cycles being 21 days in length) 6mg/kg over 30 minutes if the previous dose was well tolerated; peri-operative trastuzumab 6mg/kg IV every 3-4 weeks; post-operative trastuzumab 6mg/kg IV day 1 every 3 weeks until week 52~Carboplatin: Carboplatin AUC=6 IV per institutional guidelines on Day 1 of Cycles 1-6 (all treatment cycles are 21 days in length)"
997288|NCT00821873|B1|Baseline|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
997289|NCT00821873|P1|Participant Flow|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
997290|NCT00821873|O1|Outcome|CR Plug BackFill|Evaluation of the CR Plug for Repair of Defects Created at the Harvest Site
997295|NCT00821821|B1|Baseline|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
997296|NCT00821821|P3|Participant Flow|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
997297|NCT00821821|P2|Participant Flow|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
997298|NCT00821821|P1|Participant Flow|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
997299|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone:circa 2000mg / 72-hour infusion
997300|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone:circa 1000mg / 72-hour infusion
997301|NCT00821821|O3|Outcome|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
997302|NCT00821821|O2|Outcome|MCI-186 Cohort2|Edaravone: circa 2000 mg / 72-hour infusion
997303|NCT00821821|O1|Outcome|MCI-186 Cohort1|Edaravone: circa 1000 mg / 72-hour infusion
997304|NCT00821821|E3|Reported Event|Placebo Group|"Cohort1:circa 1000mg / 72-hour infusion matching placebo~Cohort2:circa 2000mg / 72-hour infusion matching placebo"
997305|NCT00821821|E2|Reported Event|MCI-186 Cohort2|Edaravone: circa 2000mg / 72-hour infusion
997306|NCT00821821|E1|Reported Event|MCI-186 Cohort1|Edaravone: circa 1000mg / 72-hour infusion
997307|NCT00821678|B3|Baseline|Total|Total of all reporting groups
997308|NCT00821678|B2|Baseline|Arm 2 Treatment as Usual|Treatment as usual
997309|NCT00821678|B1|Baseline|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997310|NCT00821678|P2|Participant Flow|Arm 2 Treatment as Usual|Treatment as usual
997311|NCT00821678|P1|Participant Flow|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997312|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
997313|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997314|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
997315|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997316|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
997317|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997318|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
997344|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
997345|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
997346|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
999115|NCT00817479|O2|Outcome|Dexamethasone|20 mg dexamethasone IV push
1025145|NCT00757848|O2|Outcome|Placebo|Placebo, 2 tablets twice daily (bid)
997319|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997320|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
997321|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997322|NCT00821678|O2|Outcome|Arm 2|Treatment as usual
997323|NCT00821678|O1|Outcome|Arm 1|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997324|NCT00821678|E2|Reported Event|Arm 2 Treatment as Usual|Treatment as usual
997325|NCT00821678|E1|Reported Event|Arm 1 Telemedicine Outreach for PTSD|"Telemedicine-Based Collaborative Care~Telemedicine Outreach for PTSD: The Telemedicine Outreach for PTSD (TOP) intervention will employ an off-site PTSD care team (tele-psychiatrist, tele-psychologist, tele-pharmacist, and tele-nurse care manager) and will use telemedicine technologies (telephone, interactive video and electronically shared medical records). A dedicated nurse telephone care manager will educate/activate patients, identify treatment preferences, overcome treatment barriers, monitor symptoms, side-effects and adherence, identify psychiatric comorbidities, and encourage patient self-management. Tele-pharmacists will provide medication management by phone. Tele-psychologists will provide Cognitive Processing Therapy (without exposure) via interactive video. Tele-psychiatrists will supervise the off-site care team as well as conduct consultations and provide medication management via interactive video."
997326|NCT00821587|B3|Baseline|Total|Total of all reporting groups
997327|NCT00821587|B2|Baseline|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
997328|NCT00821587|B1|Baseline|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
997329|NCT00821587|P2|Participant Flow|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
997330|NCT00821587|P1|Participant Flow|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
997331|NCT00821587|O2|Outcome|Cyclosporine (CsA)|Cyclosporine 2.0–4.0 mg/kg/day orally in two divided doses
997332|NCT00821587|O1|Outcome|Tacrolimus (TAC)|Tacrolimus 0.08–0.12 mg/kg/day orally in two divided doses
997333|NCT00821587|E2|Reported Event|Cyclosporine|Patients randomized to CsA will have TAC discontinued and will be treated with CsA at a dose of 2.0–4.0 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 150–200 ng/ml.
997334|NCT00821587|E1|Reported Event|Tacrolimus|Patients receiving TAC are treated with a dose of 0.08– 0.12 mg/kg/day orally in two divided doses with target trough whole blood concentrations of 10–15 ng/ml for the first month post-transplant followed by 5–10 ng/ml thereafter.
997335|NCT00821509|B4|Baseline|Total|Total of all reporting groups
997336|NCT00821509|B3|Baseline|Control|No change in hygiene behaviour
997337|NCT00821509|B2|Baseline|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
997338|NCT00821509|B1|Baseline|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
997339|NCT00821509|P3|Participant Flow|Control|No change in hygiene behaviour
997340|NCT00821509|P2|Participant Flow|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
997341|NCT00821509|P1|Participant Flow|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
997342|NCT00821509|O3|Outcome|Control|Participants were advised not to change their hand hygiene habits
997343|NCT00821509|O2|Outcome|Disinfectant Rubbing|Participants received behavioural instructions how to limit transmission of infections and were recommended to clean their hands frequently with an alcohol containing disinfectant solution
997347|NCT00821509|O1|Outcome|Hand Washing|Participants received behavioural instructions how to limit transmission of infections and were recommended to wash hand frequently
997348|NCT00821509|E3|Reported Event|Control|No change in hygiene behaviour
997349|NCT00821509|E2|Reported Event|Disinfectant Rubbing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent rubbing of hands with alcohol containing disinfectant in office and at home
997350|NCT00821509|E1|Reported Event|Hand Washing|Instructions for proper coughing and sneezing, and for reduced hand shaking; frequent hand washing in office and at home
997351|NCT00821431|B3|Baseline|Total|Total of all reporting groups
997352|NCT00821431|B2|Baseline|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
997353|NCT00821431|B1|Baseline|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
997354|NCT00821431|P2|Participant Flow|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
997355|NCT00821431|P1|Participant Flow|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
997356|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
997357|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
997358|NCT00821431|O2|Outcome|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
997359|NCT00821431|O1|Outcome|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
997360|NCT00821431|E2|Reported Event|Profore, 4-layer Bandage|"A high compression 4-layer bandage (Profore, Trademark of Smith and Nephew). This is a four-layer system that can be purchased either separately or as a package: a wound contact layer (Knitted viscose), a sub-compression wadding bandage, two layers of elastane bandage plus a top cohesive layer.~Profore: Subjects randomised to the 4-layer compression bandage regime, Profore, were to wear the bandage system for 24 hours a day and bandage applications/dressing changes were to be performed by a trained health care professional. Four different sizes of Profore were available and size selection was based on measurement of the ankle circumference of the subject on the index leg. Profore was to be used according to the instructions provided by the manufacturer described in their package insert."
997395|NCT00821119|B2|Baseline|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
999116|NCT00817479|O1|Outcome|Placebo|Placebo [saline]
997361|NCT00821431|E1|Reported Event|Compression Device|"The electrical compression device is operated from battery or a main adaptor. It is based upon the use of inflatable pneumatic cuffs that apply controlled compression to the foot, ankle and calf.~Compression Device: Subjects randomized to the compression device regime were instructed to wear the compression device for all wakings hours for 12 weeks. The device was applied at the following pressures:~Foot 40 mmHg, ankle 40 mmHg, mid-calf 30 mmHg, upper cuff 20 mmHg.~Subjects were instructed to wear the Intermittent Pneumatic Compression for 2 hours per day."
997362|NCT00821327|B1|Baseline|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
997363|NCT00821327|P1|Participant Flow|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
997364|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
997365|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
997366|NCT00821327|O1|Outcome|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
997367|NCT00821327|E1|Reported Event|Study Arm: Advanced/Metastatic UC|"Gemcitabine, Cisplatin, Sunitinib~Gemcitabine, Cisplatin, Sunitinib: Patients will receive gemcitabine 800 mg/m2 IV (Days 1 and 8), cisplatin 60 mg/m2 IV (Day 1), and sunitinib 37.5 mg PO daily (Days 1-14) of each 21-day cycle.~2. One cycle of treatment is defined as 21 days (3 weeks). Restaging studies will be performed after every 3 cycles of therapy.~3. Successive cycles will be initiated every 3 weeks, and will be continued through 6 cycles unless a patient shows evidence of disease progression or intolerable toxicity."
997368|NCT00821236|B4|Baseline|Total|Total of all reporting groups
997369|NCT00821236|B3|Baseline|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
997370|NCT00821236|B2|Baseline|AMO/VISX CustomVue|AMO/VISX CustomVue™
997371|NCT00821236|B1|Baseline|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
997372|NCT00821236|P1|Participant Flow|Lasik for Treatment of Nearsightedness|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment LADARVision 4000 excimer laser AMO/VISX CustomVue™ excimer laser treatment
997373|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
997374|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
997375|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
997376|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
997377|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
997378|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
997379|NCT00821236|O3|Outcome|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
997380|NCT00821236|O2|Outcome|AMO/VISX CustomVue|AMO/VISX CustomVue™
997381|NCT00821236|O1|Outcome|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
997382|NCT00821236|E3|Reported Event|LADARVision 4000 Excimer Laser|LADARVision 4000 excimer laser treatment
997383|NCT00821236|E2|Reported Event|AMO/VISX CustomVue|AMO/VISX CustomVue™
997384|NCT00821236|E1|Reported Event|Wavelight|WaveLight ALLEGRETTO WAVE™ wavefront guided or optimized excimer laser treatment
997385|NCT00821184|B3|Baseline|Total|Total of all reporting groups
997386|NCT00821184|B2|Baseline|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
997387|NCT00821184|B1|Baseline|Vesicare Alone|Vesicare alone in treatment of incontinence
997388|NCT00821184|P2|Participant Flow|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
997389|NCT00821184|P1|Participant Flow|Vesicare Alone|Vesicare alone in treatment of incontinence
997390|NCT00821184|O2|Outcome|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
997391|NCT00821184|O1|Outcome|Vesicare Alone|Vesicare alone in treatment of incontinence
997392|NCT00821184|E2|Reported Event|Vesicare Plus Behavioral Modification|Vesicare plus behavioral modification for treatment of incontinence
997393|NCT00821184|E1|Reported Event|Vesicare Alone|Vesicare alone in treatment of incontinence
997394|NCT00821119|B3|Baseline|Total|Total of all reporting groups
1000260|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
997396|NCT00821119|B1|Baseline|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
997397|NCT00821119|P2|Participant Flow|Nasal Intermittent Positive Pressure Ventilation (NIPPV)|Nasal intermittent positive pressure ventilation as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life.We used a time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 – 6 cm H2O, inspiratory time (Ti) of 0.4 – 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
997398|NCT00821119|P1|Participant Flow|Nasal Continuous Positive Airway Pressure (NCPAP)|Continuous nasal positive airway pressure as a mode of respiratory support in preterm infants with respiratory distress syndrome from birth up to 72 hours of life. Infants randomized to the NCPAP group were initiated on a pressure of 5 – 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 – 92%.
997399|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
997400|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
997401|NCT00821119|O2|Outcome|NIPPV|Preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support. These infants were treated with time-cycle, pressure-limited and continuous flow neonatal ventilator (Inter Neo, Intermed Inc., Sao Paulo, Brazil) for infants assigned to the NIPPV group, in the non-synchronized mode. The initial settings were: frequency of 20 to 30 breaths per minute, peak inspiratory pressure (PIP) of 15 to 20 cm H2O, peak end expiratory pressure (PEEP) of 4 - 6 cm H2O, inspiratory time (Ti) of 0.4 - 0.5 s and a flow of 8 - 10L/m.Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
997402|NCT00821119|O1|Outcome|NCPAP|Preterm infants with nasal continuous positive pressure as the mode of respiratory support.Infants randomized to the NCPAP group were initiated on a pressure of 5 - 6 cm H2O and a flow of 8 - 10L/m by an underwater seal (Bubble CPAP system, Intermed Inc., Sao Paulo, Brazil). Short binasal prongs were used and settings were adjusted to target a SpO2 between 88 - 92%.
997403|NCT00821119|O2|Outcome|NIPPV|preterm infants with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
997404|NCT00821119|O1|Outcome|NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
997405|NCT00821119|E2|Reported Event|2- NIPP|preterm with nasal intermittent positive pressure ventilation as a primary mode of respiratory support
997406|NCT00821119|E1|Reported Event|1 - NCPAP|preterm infants with nasal continuous positive pressure as the mode of respiratory support
997407|NCT00821093|B3|Baseline|Total|Total of all reporting groups
997408|NCT00821093|B2|Baseline|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997409|NCT00821093|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997410|NCT00821093|P2|Participant Flow|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997411|NCT00821093|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997412|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997413|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997414|NCT00821093|O2|Outcome|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997415|NCT00821093|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997416|NCT00821093|E2|Reported Event|Salmeterol 50 μg|Patients inhaled salmeterol 50 μg twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Patients also inhaled placebo to indacaterol once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997417|NCT00821093|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg once daily in the morning between 8:00 and 11:00 AM via a single-dose dry-powder inhaler (SDDPI) for 12 weeks. Patients also inhaled placebo to salmeterol twice daily, once in the morning between 8:00 and 11:00 AM and once in the evening between 8:00 and 11:00 PM via the manufacturer’s proprietary multi-dose dry-powder inhaler (MDDPI, [DISKUS]) for 12 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
997418|NCT00821041|B3|Baseline|Total|Total of all reporting groups
997419|NCT00821041|B2|Baseline|Cognitive Behavioral Therapy|
997420|NCT00821041|B1|Baseline|Waiting List Control|
997421|NCT00821041|P2|Participant Flow|Cognitive Behavioral Therapy|
997422|NCT00821041|P1|Participant Flow|Waiting List Control|
997423|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
997424|NCT00821041|O1|Outcome|Waiting List Control|
997425|NCT00821041|O2|Outcome|Cognitive Behavioral Therapy|
997426|NCT00821041|O1|Outcome|Waiting List Control|
997427|NCT00821041|E2|Reported Event|Cognitive Behavioral Therapy|
997428|NCT00821041|E1|Reported Event|Waiting List Control|
997429|NCT00820872|B1|Baseline|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
997430|NCT00820872|P1|Participant Flow|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
997431|NCT00820872|O1|Outcome|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
997432|NCT00820872|E1|Reported Event|Group 1|Patients receive docetaxel IV over 60 minutes and carboplatin IV over 30 minutes on day 1, trastuzumab (Herceptin®) IV over 30-90 minutes on days 1, 8, and 15, and oral lapatinib ditosylate on days 1-21 (TCHL). Treatment with TCHL repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Patients then receive trastuzumab IV over 30-90 minutes on day 1 and oral lapatinib ditosylate on days 1-21 (days 1-7 of course 12 only) (LT). Treatment with LT repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 6 months for 2 years and then annually for up to 8 years.
997446|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997734|NCT00819832|P5|Participant Flow|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
997433|NCT00820755|B1|Baseline|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
997434|NCT00820755|P3|Participant Flow|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997435|NCT00820755|P2|Participant Flow|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997436|NCT00820755|P1|Participant Flow|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
997437|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997438|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997439|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997440|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997441|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
997442|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997443|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997444|NCT00820755|O1|Outcome|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
997445|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997447|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997448|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997449|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997450|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997451|NCT00820755|O2|Outcome|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997452|NCT00820755|O1|Outcome|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 500 mg/m^2 as intravenous infusion every 2 weeks, until progressive disease (PD), unacceptable toxicity, or withdrawal of consent.
997453|NCT00820755|E3|Reported Event|Cetuximab 250 mg/m^2 Weekly|Participants who were free of disease progression at the end of combination therapy, entered in the maintenance therapy period. In the maintenance period, participants received cetuximab 250 mg/m^2 as intravenous infusion weekly, until PD, unacceptable toxicity, or withdrawal of consent.
997454|NCT00820755|E2|Reported Event|Cetuximab 500 mg/m^2 Every 2 Weeks|Participants who were free of disease progression after combination therapy, they administered with cetuximab 500 mg/m^2 intravenously for 2 weeks, for up to PD, development of unacceptable toxicities, or withdrawal of consent after the end of combination therapy.
997455|NCT00820755|E1|Reported Event|Cetuximab 250 mg/m^2 q1w + Platinum-based Doublet Chemotherapy|Combination Phase: Single first dose of cetuximab 400 milligram per square meter (mg/m^2) infusion administered intravenously over 120 minutes (min) followed by cetuximab 250 mg/m^2 intravenous infusion over 60 min weekly (q1w) with background platinum-based doublet chemotherapy up to maximum of 6 cycles, until progressive disease, unacceptable toxicity, or withdrawal of consent. Platinum based doublet chemotherapy infusion intravenously as per study center included: vinorelbine 25 mg/m^2 on Day 1 (D1) and Day 8 (D8)+cisplatin 80 mg/m^2 on D1; or gemcitabine 1250 mg/m^2 on D1 and D8+cisplatin 75 mg/m^2 on D1; or gemcitabine 1000 mg/m^2 on D1 and D8+carboplatin at dose to reach area under curve (AUC)5 mg*hour/milliliter (mg*h/mL) on D1; or Docetaxel 75 mg/m^2 on D1+cisplatin 75 mg/m^2 on D1; or paclitaxel 175 mg/m^2 on D1+cisplatin 80 mg/m^2 on D1; or paclitaxel 200 mg/m^2 on D1+carboplatin at dose to reach AUC6 mg*h/mL on D1, of each 3-week treatment cycle for a maximum of 6 cycles.
997456|NCT00820664|B4|Baseline|Total|Total of all reporting groups
997457|NCT00820664|B3|Baseline|Placebo|
997458|NCT00820664|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
997459|NCT00820664|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
997460|NCT00820664|P3|Participant Flow|Placebo|
997461|NCT00820664|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
997462|NCT00820664|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
997463|NCT00820664|O3|Outcome|Placebo|
997464|NCT00820664|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
997465|NCT00820664|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
997466|NCT00820664|E3|Reported Event|Placebo|
997467|NCT00820664|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablet
997468|NCT00820664|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2.0 mg tablet
997469|NCT00820612|B3|Baseline|Total|Total of all reporting groups
997470|NCT00820612|B2|Baseline|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997471|NCT00820612|B1|Baseline|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997472|NCT00820612|P2|Participant Flow|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997473|NCT00820612|P1|Participant Flow|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997474|NCT00820612|O2|Outcome|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997475|NCT00820612|O1|Outcome|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997476|NCT00820612|E2|Reported Event|Indomethacin|2 50-mg indomethacin suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997477|NCT00820612|E1|Reported Event|Placebo|2 placebo suppositories. The suppositories were administered immediately after ERCP while the patient was still in the procedure room.
997478|NCT00820573|B5|Baseline|Total|Total of all reporting groups
997479|NCT00820573|B4|Baseline|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
997480|NCT00820573|B3|Baseline|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
997481|NCT00820573|B2|Baseline|Metformin|all subjects after receiving 6 weeks of metformin therapy
997482|NCT00820573|B1|Baseline|Placebo|all subjects after 6 weeks of placebo therapy
1003679|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
997483|NCT00820573|P4|Participant Flow|Sitagliptin Plus Metformin, Sitagliptin, Placebo,Metformin|Sequence as described, starting with combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily placebo therapy for 6 weeks and finally metforminfor 6 weeks.
997484|NCT00820573|P3|Participant Flow|Metformin, Sitagliptin Plus Metformin, Sitagliptin,Placebo|Sequence as described, starting with metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks, then sitagliptin 100 mg daily followed by placebo therapy for the final 6 weeks
997485|NCT00820573|P2|Participant Flow|Sitagliptin, Metformin, Sitagliptin Plus Metformin, Placebo|Sequence as described, starting with sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks, combination sitagliptn plus metformin for 6 weeks and then placebo therapy for the final 6 weeks
997486|NCT00820573|P1|Participant Flow|Placebo,Sitagliptin,Metformin and Sitagliptin Plus Metformin|Sequence as described, starting placebo therapy for 6 weeks,followed by sitagliptin 100 mg once daily, then metformin 1000 mg twice daily for 6 weeks and the combination sitagliptn plus metformin for the final 6 weeks
997487|NCT00820573|O4|Outcome|Sitagliptin+Metformin|placebo for 6 weeks
997488|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin~Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
997489|NCT00820573|O2|Outcome|Metformin|"Metformin~Metformin : tablet, 1000 mg/ bid, 6 weeks"
997490|NCT00820573|O1|Outcome|Placebo|"Sitagliptin~Sitagliptin : tablet, 100 mg/day, 6 weeks"
997491|NCT00820573|O4|Outcome|Sitagliptin + Metformin|placebo for 6 weeks
997492|NCT00820573|O3|Outcome|Sitagliptin|"Sitagliptin + Metformin~Sitagliptin and Metformin : tablet, Sitagliptin (100mg/day) + tablet, Metformin (1000 mg/bid), 6 weeks"
997493|NCT00820573|O2|Outcome|Metformin|"Metformin~Metformin : tablet, 1000 mg/ bid, 6 weeks"
997494|NCT00820573|O1|Outcome|Placebo|"Sitagliptin~Sitagliptin : tablet, 100 mg/day, 6 weeks"
997495|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
997496|NCT00820573|O3|Outcome|Sitagliptin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
997497|NCT00820573|O2|Outcome|Metformin|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin
997498|NCT00820573|O1|Outcome|Placebo|All participants received 6 weeks continuous therapy in random order of the following: placebo, metformin, sitagliptin and the combination sitagliptin plus metformin.
997499|NCT00820573|O4|Outcome|Sitagliptin Plus Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
997500|NCT00820573|O3|Outcome|Sitagliptin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
997501|NCT00820573|O2|Outcome|Metformin|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
997502|NCT00820573|O1|Outcome|Placebo|All participants received placebo, metformin, sitagliptin and the combination therapy for 6 weeks in random order
997503|NCT00820573|E4|Reported Event|Metformin Plus Sitagliptin|all subjects after receiving 6 weeks of combined sitagliptin plus metformin therpay
997504|NCT00820573|E3|Reported Event|Sitagliptin|all subjects after receiving 6 weeks of sitagliptin therapy
997505|NCT00820573|E2|Reported Event|Metformin|all subjects after receiving 6 weeks of metformin therapy
997506|NCT00820573|E1|Reported Event|Placebo|all subjects after 6 weeks of placebo therapy
997507|NCT00820534|B3|Baseline|Total|Total of all reporting groups
997508|NCT00820534|B2|Baseline|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
997509|NCT00820534|B1|Baseline|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
997510|NCT00820534|P2|Participant Flow|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
997511|NCT00820534|P1|Participant Flow|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
997512|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
997513|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
997514|NCT00820534|O2|Outcome|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
997515|NCT00820534|O1|Outcome|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
997516|NCT00820534|E2|Reported Event|Placebo|Placebo cream every 2 hours during waking hours for 96 hours
997517|NCT00820534|E1|Reported Event|Penciclovir|Penciclovir 10mg/g (1%) cream every 2 hours during waking hours for 96 hours
997518|NCT00820443|B1|Baseline|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
997519|NCT00820443|P1|Participant Flow|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
997520|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
997521|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component"
997522|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
997523|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
997524|NCT00820443|O1|Outcome|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
1003680|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
997525|NCT00820443|E1|Reported Event|Ceramic on Metal Prosthesis|"Ceramic on metal prosthesis~Ceramic on metal prosthesis: Ceramic femoral head with a metal acetabular component Ceramic large head with monoblock or modular acetabular component"
997526|NCT00820222|B3|Baseline|Total|Total of all reporting groups
997527|NCT00820222|B2|Baseline|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997528|NCT00820222|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997529|NCT00820222|P2|Participant Flow|Trastuzumab Plus Capecitabine|Participants received an intravenous (IV) infusion of trastuzumab 8 mg/kilogram (kg) on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997530|NCT00820222|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997531|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997532|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997533|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997534|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997535|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997536|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997537|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997538|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997539|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997735|NCT00819832|P4|Participant Flow|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
997540|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997541|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997542|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997543|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997544|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997545|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997546|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997547|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997548|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997549|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997550|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997551|NCT00820222|O2|Outcome|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997552|NCT00820222|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997553|NCT00820222|E2|Reported Event|Trastuzumab Plus Capecitabine|Participants received an IV infusion of trastuzumab 8 mg/kg on Day 1, followed by a 6 mg/kg infusion every 3 weeks. Participants also received capecitabine 2500 mg/m^2 per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997554|NCT00820222|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 mg) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg/m^2) per day (divided and administered orally twice daily, 12 hours apart), for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after food. Participants received study medication until disease progression, unacceptable toxicity, or participant withdrawal.
997555|NCT00819182|B4|Baseline|Total|Total of all reporting groups
997556|NCT00819182|B3|Baseline|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997557|NCT00819182|B2|Baseline|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997558|NCT00819182|B1|Baseline|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997559|NCT00819182|P3|Participant Flow|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997560|NCT00819182|P2|Participant Flow|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997561|NCT00819182|P1|Participant Flow|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997562|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997563|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997564|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997565|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997566|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997567|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997568|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997569|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997570|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997571|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997572|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997573|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997574|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997575|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997576|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997577|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997578|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997579|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997580|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997581|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997582|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997583|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997584|NCT00819182|O3|Outcome|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997585|NCT00819182|O2|Outcome|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997615|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997616|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997736|NCT00819832|P3|Participant Flow|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
997586|NCT00819182|O1|Outcome|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997587|NCT00819182|E3|Reported Event|Usual Care|The usual care group received an investigator-signed letter explaining they were not selected to receive any study materials during the 16-week follow-up. These participants received paced respiration materials by mail after study completion.
997588|NCT00819182|E2|Reported Event|Fast, Shallow Breathing|The fast, shallow comparator group received a digital videodisc with paper booklet. The booklet reinforced voice-over and video demonstration to practice twice per day and apply the fast shallow breathing at the onset of each flash.
997589|NCT00819182|E1|Reported Event|Paced Respiration|The paced respiration intervention group received a compact disc with paper booklet. The booklet reinforced instructions on the first audio track for how to accomplish a target breath rate of 6-8 breaths per minute, practice twice per day for 15 minutes, and apply the breathing at the onset of each hot flash. Women were instructed to do slow, deep, abdominal breathing in through the nose and out through the mouth as per international recommendations. They were also instructed to practice twice per day for 15 minutes as per the small, laboratory-based studies. The second and third tracks contained specially composed, digitally recorded music to help entrain the breath rate and structure the length of practice.
997590|NCT00819156|B7|Baseline|Total|Total of all reporting groups
997591|NCT00819156|B6|Baseline|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997592|NCT00819156|B5|Baseline|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997593|NCT00819156|B4|Baseline|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997594|NCT00819156|B3|Baseline|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997595|NCT00819156|B2|Baseline|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997596|NCT00819156|B1|Baseline|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997597|NCT00819156|P6|Participant Flow|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997598|NCT00819156|P5|Participant Flow|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997599|NCT00819156|P4|Participant Flow|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997600|NCT00819156|P3|Participant Flow|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997601|NCT00819156|P2|Participant Flow|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997602|NCT00819156|P1|Participant Flow|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997603|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997604|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997605|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997606|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997607|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997608|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997609|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997610|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997611|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997612|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997613|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997614|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997737|NCT00819832|P2|Participant Flow|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
997617|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997618|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997619|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997620|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997621|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997622|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997623|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997624|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997625|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997626|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997627|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997628|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997629|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997630|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997631|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997632|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997633|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997634|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997635|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997636|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997637|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997638|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997639|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997640|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997641|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997642|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997643|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997644|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997645|NCT00819156|O5|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997646|NCT00819156|O4|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997647|NCT00819156|O3|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997648|NCT00819156|O2|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997649|NCT00819156|O1|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997650|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997733|NCT00819832|P6|Participant Flow|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
997651|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997652|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997653|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997654|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997655|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997656|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997657|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997658|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997659|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997660|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997661|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997662|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997663|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997664|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997665|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997666|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997667|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997668|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997669|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997670|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997671|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997672|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997673|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997674|NCT00819156|O3|Outcome|Maintenance Dose of 160 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 160 milligram per cycle in cycles 2-13 have been combined.
997675|NCT00819156|O2|Outcome|Maintenance Dose of 120 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 120 milligram per cycle in cycles 2-13 have been combined.
997676|NCT00819156|O1|Outcome|Maintenance Dose of 80 Milligram Per Cycle|The two treatment groups that have a maintenance dose of 80 milligram per cycle in cycles 2-13 have been combined.
997677|NCT00819156|O6|Outcome|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997678|NCT00819156|O5|Outcome|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997679|NCT00819156|O4|Outcome|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997680|NCT00819156|O3|Outcome|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997681|NCT00819156|O2|Outcome|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997682|NCT00819156|O1|Outcome|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997683|NCT00819156|E6|Reported Event|Degarelix 240/160|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997684|NCT00819156|E5|Reported Event|Degarelix 240/120|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997685|NCT00819156|E4|Reported Event|Degarelix 240/80|Cycle 1 was an initial 240 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997686|NCT00819156|E3|Reported Event|Degarelix 200/160|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 160 milligrams each of Degarelix. Each cycle was 28 days.
997687|NCT00819156|E2|Reported Event|Degarelix 200/120|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 120 milligrams each of Degarelix. Each cycle was 28 days.
997688|NCT00819156|E1|Reported Event|Degarelix 200/80|Cycle 1 was an initial 200 milligram dose of Degarelix. Cycles 2-13 were maintainance doses of 80 milligrams each of Degarelix. Each cycle was 28 days.
997689|NCT00817596|B1|Baseline|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
997690|NCT00817596|P1|Participant Flow|Prometra Intrathecal Pump System|This group was treated with an intrathecal pump implant. Pumps were filled with morphine sulfate. Dosage, concentration, and other programmable parameters were prescribed at the discretion of the physician.
997691|NCT00817596|O1|Outcome|Group 1|Prometra Intrathecal Pump System
997692|NCT00817596|E1|Reported Event|Group 1|Prometra Intrathecal Pump System
997693|NCT00819910|B5|Baseline|Total|Total of all reporting groups
997694|NCT00819910|B4|Baseline|Placebo Therapy Daily|Placebo (Rosiglitazone 8mg once daily) and placebo (Fenofibrate 145 mg once daily) for 12 weeks
997695|NCT00819910|B3|Baseline|Rosiglitazone + Placebo|Rosiglitazone 8mg once daily and Placebo ( Fenofibrate 145mg once daily)
997696|NCT00819910|B2|Baseline|Fenofibrate + Placebo|Fenofibrate 145mg once daily for 12 weeks and Placebo (Rosiglitazone 8mg once daily)
997697|NCT00819910|B1|Baseline|Rosiglitazone/Fenofibrate Therapy Daily|Rosiglitazone 8mg once daily and Fenofibrate 145mg once daily for 12 weeks
997698|NCT00819910|P4|Participant Flow|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997699|NCT00819910|P3|Participant Flow|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
997700|NCT00819910|P2|Participant Flow|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
997701|NCT00819910|P1|Participant Flow|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997702|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997703|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
997704|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
997705|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997706|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997707|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
997708|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
997709|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997710|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997711|NCT00819910|O3|Outcome|Rosiglitazone + Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
997712|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
997713|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997714|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997715|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
997716|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
997717|NCT00819910|O1|Outcome|Rosiglitazone and Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997718|NCT00819910|O4|Outcome|Placebo Therapy Daily|Placebo (Rosiglitazone) 8mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997719|NCT00819910|O3|Outcome|Rosiglitazone +Fenofibrate|Rosiglitazone 8mg daily + Fenofibrate 145mg daily for 12 weeks
997720|NCT00819910|O2|Outcome|Fenofibrate + Placebo|Fenofibrate 145mg daily + Placebo (Rosiglitazone) 8mg daily for 12weeks
997721|NCT00819910|O1|Outcome|Rosiglitazone + Placebo|Rosiglitazone 8 mg daily + Placebo (Fenofibrate) 145 mg daily for 12 weeks
997722|NCT00819910|E4|Reported Event|Placebo Therapy Daily|"Rosiglitazone (placebo) once daily and Fenofibrate (placebo)once daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
997723|NCT00819910|E3|Reported Event|Fenofibrate + Placebo|"Fenofibrate 145 mg po daily for 12 weeks= Placebo (Rosiglitazone 8mg po daily)~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
997724|NCT00819910|E2|Reported Event|Rosiglitazone + Placebo|"Rosiglitazone 8mg po daily + Placebo (Fenofibrate 145 mg po daily) for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
997725|NCT00819910|E1|Reported Event|Rosiglitazone/Fenofibrate Therapy Daily|"Rosiglitazone 8mg po daily + Fenofibrate 145 mg po daily for 12 weeks~These are the adverse events reported in population who continued the 12 weeks of therapy as well as the population that dropped out."
997726|NCT00819832|B7|Baseline|Total|Total of all reporting groups
997727|NCT00819832|B6|Baseline|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
997728|NCT00819832|B5|Baseline|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
997729|NCT00819832|B4|Baseline|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
997730|NCT00819832|B3|Baseline|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
997731|NCT00819832|B2|Baseline|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
997732|NCT00819832|B1|Baseline|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
997738|NCT00819832|P1|Participant Flow|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
997739|NCT00819832|O6|Outcome|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
997740|NCT00819832|O5|Outcome|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
997741|NCT00819832|O4|Outcome|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
997742|NCT00819832|O3|Outcome|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
997743|NCT00819832|O2|Outcome|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
997744|NCT00819832|O1|Outcome|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
997745|NCT00819832|E6|Reported Event|Phase 2 Group 4 Kyphoplasty + Cavity SpineWand|Kyphoplasty with Cavity SpineWand
997746|NCT00819832|E5|Reported Event|Phase 2 Group 3 Kyphoplasty|Kyphoplasty
997747|NCT00819832|E4|Reported Event|Phase 2 Group 2 Vertebroplasty +Cavity SpineWand|Vertebroplasty with Cavity SpineWand
997748|NCT00819832|E3|Reported Event|Phase 2 Group 1 Vertebroplasty|Vertebroplasty
997749|NCT00819832|E2|Reported Event|Phase 1 Group 2 Kyphoplasty|Kyphoplasty
997750|NCT00819832|E1|Reported Event|Phase 1 Group 1 Vertebroplasty|Vertebroplasty
997751|NCT00819780|B3|Baseline|Total|Total of all reporting groups
997752|NCT00819780|B2|Baseline|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997753|NCT00819780|B1|Baseline|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997754|NCT00819780|P2|Participant Flow|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2), followed by 5-FU (2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
997755|NCT00819780|P1|Participant Flow|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and modified FOLFOX6 (mFOLFOX6) chemotherapy regimen consisting of oxaliplatin (85 mg/m^2), leucovorin (400 mg/m^2) and 5-fluorouracil (5-FU; 2400 mg/m^2) administered on Day 1 of every 14-day cycle until disease progression, unacceptable toxicity, withdrawal of consent, or death.
997756|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997757|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997758|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997759|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997760|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997761|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997762|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997763|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997764|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997765|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997766|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997767|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997768|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997769|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997770|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997771|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997772|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997773|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997774|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997775|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997776|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997843|NCT00819637|O3|Outcome|Levalbuterol 3 Doses|
997844|NCT00819637|O2|Outcome|Arformoterol 3 Doses|
997777|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997778|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997779|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997780|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997781|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997782|NCT00819780|O2|Outcome|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997783|NCT00819780|O1|Outcome|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997784|NCT00819780|E2|Reported Event|Bevacizumab Plus mFOLFOX6|Participants received 5 mg/kg bevacizumab administered by IV infusion and the mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997785|NCT00819780|E1|Reported Event|Panitumumab Plus mFOLFOX6|Participants received 6 mg/kg panitumumab administered by intravenous (IV) infusion and mFOLFOX6 chemotherapy regimen on Day 1 of every 14-day cycle.
997786|NCT00819767|B3|Baseline|Total|Total of all reporting groups
997787|NCT00819767|B2|Baseline|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997788|NCT00819767|B1|Baseline|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997789|NCT00819767|P2|Participant Flow|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997790|NCT00819767|P1|Participant Flow|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997791|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997792|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997793|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997794|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997795|NCT00819767|O2|Outcome|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997845|NCT00819637|O1|Outcome|Arformoterol 1 Dose, Placebo 2 Doses|
997846|NCT00819637|E3|Reported Event|Levalbuterol 3 Doses|
997847|NCT00819637|E2|Reported Event|Arformoterol 3 Doses|
997796|NCT00819767|O1|Outcome|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997797|NCT00819767|E2|Reported Event|Valsartan|For the first week of the 8 week treatment period, patients received valsartan 160 mg, placebo to valsartan, and 2 tablets of placebo to aliskiren. For the remaining 7 weeks of the study, patients received valsartan 320 mg (two 160 mg capsules) and 2 tablets of placebo to aliskiren. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997798|NCT00819767|E1|Reported Event|Aliskiren|For the first week of the 8 week treatment period, patients received aliskiren 150 mg, placebo to aliskiren, and 2 capsules of placebo to valsartan. For the remaining 7 weeks of the study, patients received aliskiren 300 mg (two 150 mg tablets) and 2 capsules of placebo to valsartan. The tablets and capsules (2 of each) were taken orally once daily each morning. To evaluate a missed dose, the last dose of medication was administered at the clinic, and the patient was scheduled to return 2 days later for exercise testing (8 weeks + 2 days).
997799|NCT00819741|B3|Baseline|Total|Total of all reporting groups
997800|NCT00819741|B2|Baseline|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997801|NCT00819741|B1|Baseline|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997802|NCT00819741|P2|Participant Flow|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997803|NCT00819741|P1|Participant Flow|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997804|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997805|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997806|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997807|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997808|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997809|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997810|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997811|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997812|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997813|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997814|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997815|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997848|NCT00819637|E1|Reported Event|Arformoterol 1 Dose, Placebo 2 Doses|
997849|NCT00819585|B8|Baseline|Total|Total of all reporting groups
997816|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997817|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997818|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997819|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997820|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997821|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997822|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997823|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997824|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997825|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997826|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997827|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997828|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997829|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997830|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997831|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997832|NCT00819741|O2|Outcome|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997833|NCT00819741|O1|Outcome|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997834|NCT00819741|E2|Reported Event|Repaglinide|Initial dose of repaglinide 1 mg three times daily. During the dose titration period of 6 weeks, the dose of repaglinide could be titrated up to 4 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg three times daily.
997835|NCT00819741|E1|Reported Event|Repaglinide + Metformin|Initial dose of repaglinide 1mg plus metformin 500mg once daily. During the dose titration period of 6 weeks, the dose could be titrated up to repaglinide 4 mg and metformin 500 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 1 mg plus metformin 500 mg three times daily.
997836|NCT00819637|B4|Baseline|Total|Total of all reporting groups
997837|NCT00819637|B3|Baseline|Levalbuterol 3 Doses|
997838|NCT00819637|B2|Baseline|Arformoterol 3 Doses|
997839|NCT00819637|B1|Baseline|Arformoterol 1 Dose, Placebo 2 Doses|
997840|NCT00819637|P3|Participant Flow|Levalbuterol 3 Doses|
997841|NCT00819637|P2|Participant Flow|Arformoterol 3 Doses|
997842|NCT00819637|P1|Participant Flow|Arformoterol 1 Dose, Placebo 2 Doses|
997850|NCT00819585|B7|Baseline|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997851|NCT00819585|B6|Baseline|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997852|NCT00819585|B5|Baseline|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997853|NCT00819585|B4|Baseline|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997854|NCT00819585|B3|Baseline|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997855|NCT00819585|B2|Baseline|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997856|NCT00819585|B1|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997857|NCT00819585|P7|Participant Flow|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997858|NCT00819585|P6|Participant Flow|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997859|NCT00819585|P5|Participant Flow|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997860|NCT00819585|P4|Participant Flow|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997861|NCT00819585|P3|Participant Flow|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997862|NCT00819585|P2|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997863|NCT00819585|P1|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997864|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997865|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
998084|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
997866|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997867|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997868|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997869|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997870|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997871|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997872|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997873|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997874|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997875|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997876|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997877|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997878|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997879|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997880|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997881|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
998076|NCT00819247|P1|Participant Flow|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998294|NCT00819091|E1|Reported Event|Placebo|Matching placebo tablet taken orally once daily
997882|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997883|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997884|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997885|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997886|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997887|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997888|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997889|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997890|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997891|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997892|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997893|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997894|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997895|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997896|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997897|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
998077|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998295|NCT00819052|B3|Baseline|Total|Total of all reporting groups
997898|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997899|NCT00819585|O7|Outcome|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997900|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997901|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997902|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997903|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997904|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997905|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997906|NCT00819585|O6|Outcome|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997907|NCT00819585|O5|Outcome|Canakinumab 300 mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997908|NCT00819585|O4|Outcome|Canakinumab 200 mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997909|NCT00819585|O3|Outcome|Canakinumab 100 mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997910|NCT00819585|O2|Outcome|Canakinumab 50 mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997911|NCT00819585|O1|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997912|NCT00819585|E7|Reported Event|Colchicine 0.5 mg|Colchicine 0.5 mg capsule orally once daily throughout the whole treatment phase of 16 weeks plus placebo matching canakinumab s.c. at Days 1, 29, 57, and 85. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997913|NCT00819585|E6|Reported Event|Canakinumab q4wk|Canakinumab 50 mg s.c. at Days 1, and 29 followed by canakinumab 25 mg s.c. on Days 57, and 85 plus daily placebo capsules for 16 weeks, repeated every 4 week (q4wk). Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
998078|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
997914|NCT00819585|E5|Reported Event|Canakinumab 300mg|Canakinumab 300 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg-300 mg) for 24 weeks.
997915|NCT00819585|E4|Reported Event|Canakinumab 200mg|Canakinumab 200 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997916|NCT00819585|E3|Reported Event|Canakinumab 100mg|Canakinumab 100 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997917|NCT00819585|E2|Reported Event|Canakinumab 50mg|Canakinumab 50 mg s.c. once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997918|NCT00819585|E1|Reported Event|Canakinumab 25mg|Canakinumab 25 mg subcutaneously (s.c.) once at Day 1, placebo s.c. at Days 29, 57, and 85 plus daily placebo capsules for 16 weeks. Allopurinol treatment was initiated at the latest at baseline (Visit 2) according to the patient's renal function / estimated creatinine clearance at screening (Visit 1). Allopurinol was administered orally to all randomized patients once daily (100 mg- 300 mg) for 24 weeks.
997919|NCT00819403|B3|Baseline|Total|Total of all reporting groups
997920|NCT00819403|B2|Baseline|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
997921|NCT00819403|B1|Baseline|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
997922|NCT00819403|P2|Participant Flow|Simvastatin/Ezetimibe Then Simvastatin|Subjects will receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied.
997923|NCT00819403|P1|Participant Flow|Simvastatin Then Simvastatin/Ezetimibe|"Simvastatin 40 mg daily then simvastatin/ezetimibe 10/40 mg daily~Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied. Subjects will then receive 6 weeks of simvastatin/ezetimibe 10/40 mg, after which atherothrombotic biomarker assessment will be studied."
997924|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Ezetimibe/simvastatin 10/40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
997925|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
997926|NCT00819403|O2|Outcome|Simvastatin/Ezetimibe|Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
997927|NCT00819403|O1|Outcome|Simvastatin|Simvastatin 40 mg daily for 6 weeks, after which atherothrombotic biomarker assessment will be studied.
997928|NCT00819403|E2|Reported Event|Simvastatin/Ezetimibe|"Subjects will receive 6 weeks of ezetimibe/simvastatin 10/40 mg, after which atherothrombotic biomarker assessment will be studied.~ezetimibe/simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
997929|NCT00819403|E1|Reported Event|Simvastatin|"Simvastatin 40 mg daily~simvastatin : Subjects will receive 6 weeks of simvastatin 40 mg, after which atherothrombotic biomarker assessment will be studied."
997930|NCT00819390|B5|Baseline|Total|Total of all reporting groups
997931|NCT00819390|B4|Baseline|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997932|NCT00819390|B3|Baseline|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997933|NCT00819390|B2|Baseline|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997934|NCT00819390|B1|Baseline|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997935|NCT00819390|P4|Participant Flow|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997936|NCT00819390|P3|Participant Flow|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997937|NCT00819390|P2|Participant Flow|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997938|NCT00819390|P1|Participant Flow|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997939|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997940|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997941|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997942|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997943|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997944|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997945|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997946|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997947|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997948|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997949|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997950|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997951|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997952|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997953|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997954|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997955|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997956|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997957|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998079|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
997958|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997959|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997960|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997961|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997962|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997963|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997964|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997965|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997966|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997967|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997968|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997969|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997970|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997971|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997972|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997973|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997974|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997975|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997976|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997977|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998080|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
997978|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997979|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997980|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997981|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997982|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997983|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997984|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997985|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997986|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997987|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997988|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997989|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997990|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997991|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997992|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997993|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997994|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997995|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997996|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997997|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998081|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
997998|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
997999|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998000|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998001|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998002|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998003|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998004|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998005|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998006|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998007|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998008|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998009|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998010|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998011|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998012|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998013|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998014|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998015|NCT00819390|O2|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998016|NCT00819390|O1|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998017|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998082|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998018|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998019|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998020|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998021|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998022|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998023|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998024|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998025|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998026|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998027|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998028|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998029|NCT00819390|O2|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998030|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998031|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998032|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998033|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998034|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998035|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998036|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998037|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998083|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998038|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998039|NCT00819390|O4|Outcome|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998040|NCT00819390|O3|Outcome|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998041|NCT00819390|O2|Outcome|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998042|NCT00819390|O1|Outcome|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998043|NCT00819390|E4|Reported Event|D: Placebo Then Chloroquine for On-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998044|NCT00819390|E3|Reported Event|C: Chloroquine Then Placebo for On-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998045|NCT00819390|E2|Reported Event|B: Placebo Then Chloroquine for Off-ART Participants|"Participants received chloroquine placebo treatment from Day 0 through the Week 12 study visit and then began chloroquine treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998046|NCT00819390|E1|Reported Event|A: Chloroquine Then Placebo for Off-ART Participants|"Participants received chloroquine treatment from Day 0 through the Week 12 study visit and then began chloroquine placebo treatment until the Week 24 study visit.~Chloroquine: Taken orally, once daily, at a dose of 250 mg for 12 weeks.~Placebo: Taken orally, once daily for 12 weeks."
998047|NCT00819286|B3|Baseline|Total|Total of all reporting groups
998048|NCT00819286|B2|Baseline|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
998049|NCT00819286|B1|Baseline|Wire (Control)|patients will have their sternum closed using stainless steel wires.
998050|NCT00819286|P2|Participant Flow|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
998051|NCT00819286|P1|Participant Flow|Wire (Control)|patients will have their sternum closed using stainless steel wires.
998052|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
998053|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
998054|NCT00819286|O2|Outcome|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
998055|NCT00819286|O1|Outcome|Wire (Control)|patients will have their sternum closed using stainless steel wires.
998056|NCT00819286|E2|Reported Event|Plates|patients will have their sternum closed by rigid fixation using SternaLock plates.
998057|NCT00819286|E1|Reported Event|Wire (Control)|patients will have their sternum closed using stainless steel wires.
998058|NCT00819260|B1|Baseline|All Participants|Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery.
998059|NCT00819260|P1|Participant Flow|All Participants|All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery.
998060|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
998061|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
998062|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
998063|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
998064|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
998065|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
998066|NCT00819260|O2|Outcome|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
998067|NCT00819260|O1|Outcome|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
998068|NCT00819260|E2|Reported Event|Electrocautery Reduced Breast|Electrocautery (current practice = control) used to reduce breast on that side
998069|NCT00819260|E1|Reported Event|Harmonic Reduced Breast|harmonic scalpel used to reduce breast on that side
998070|NCT00819247|B4|Baseline|Total|Total of all reporting groups
998071|NCT00819247|B3|Baseline|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998072|NCT00819247|B2|Baseline|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998073|NCT00819247|B1|Baseline|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998074|NCT00819247|P3|Participant Flow|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998075|NCT00819247|P2|Participant Flow|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998085|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998086|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998087|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998088|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998089|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998090|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998091|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998092|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998093|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998094|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998095|NCT00819247|O3|Outcome|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998096|NCT00819247|O2|Outcome|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998097|NCT00819247|O1|Outcome|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998098|NCT00819247|E3|Reported Event|Degarelix 80 + 20|Loading dose of Degarelix 80 mg on Day 0. Maintenance doses of 20 mg given on days 28, 56, 84, 112 and 140.
998099|NCT00819247|E2|Reported Event|Degarelix 40/40 + 40|Loading doses of Degarelix 40 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998100|NCT00819247|E1|Reported Event|Degarelix 80/80 + 40|Loading doses of Degarelix 80 mg on Days 0 and 3. Maintenance doses of 40 mg given on days 28, 56, 84, 112 and 140.
998101|NCT00819234|B1|Baseline|All Participants|All participants who completed the original study and chose to enter the extension study.
998102|NCT00819234|P10|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998103|NCT00819234|P9|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998104|NCT00819234|P8|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998105|NCT00819234|P7|Participant Flow|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
998106|NCT00819234|P6|Participant Flow|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
998107|NCT00819234|P5|Participant Flow|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study for up to 52 Weeks, inclusive of DFA102.
998108|NCT00819234|P4|Participant Flow|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998109|NCT00819234|P3|Participant Flow|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998110|NCT00819234|P2|Participant Flow|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998111|NCT00819234|P1|Participant Flow|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998168|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
1003681|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
998112|NCT00819234|O6|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998113|NCT00819234|O5|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998114|NCT00819234|O4|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Prior Monotherapy|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998115|NCT00819234|O3|Outcome|360 mcg Pramlintide + Metreleptin 5 mg - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998116|NCT00819234|O2|Outcome|360 mcg Pramlintide + Metreleptin 2.5 mg - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998117|NCT00819234|O1|Outcome|360 mcg Pramlintide + Metreleptin 1.25 mg - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998118|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998119|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998120|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998121|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998122|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998123|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998124|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998125|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998126|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998127|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998128|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998129|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998169|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998130|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998131|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998132|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998133|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998134|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998135|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998136|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998137|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998138|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998139|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998140|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998141|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998142|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998143|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998144|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998145|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998146|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998147|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998148|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998149|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998150|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998151|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998152|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998153|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998154|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998155|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998156|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998157|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998158|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998159|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998160|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998161|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998162|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998163|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998164|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998165|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998166|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998167|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998170|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|"Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998171|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998172|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998173|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998174|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998175|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998176|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998177|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998178|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998179|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998180|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998181|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998182|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998183|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998184|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998185|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998186|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998187|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998188|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998189|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998190|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
998191|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998192|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998193|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998194|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998195|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998196|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998197|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998198|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998199|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998200|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
998201|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998202|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998203|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998204|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998205|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998296|NCT00819052|B2|Baseline|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
1003682|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
998206|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998207|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998208|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998209|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998210|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998211|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998212|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998213|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998214|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998215|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998216|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998217|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998218|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998219|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998220|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998221|NCT00819234|O10|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998222|NCT00819234|O9|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998223|NCT00819234|O8|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed, to minimize nausea and/or vomiting.
998255|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
998224|NCT00819234|O7|Outcome|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998225|NCT00819234|O6|Outcome|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998226|NCT00819234|O5|Outcome|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998227|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998228|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998229|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998230|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
998231|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998232|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998233|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998234|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
998235|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998236|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998237|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998238|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
998239|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998240|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998241|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998242|NCT00819234|O1|Outcome|Placebo - Stable|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
998243|NCT00819234|O4|Outcome|360 mcg Pramlintide + 5.0 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998244|NCT00819234|O3|Outcome|360 mcg Pramlintide + 2.5 Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998245|NCT00819234|O2|Outcome|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.
998246|NCT00819234|O1|Outcome|Placebo|Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.
998247|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
998248|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
998249|NCT00819234|O1|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for up to 52 Weeks, inclusive of DFA102.
998250|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
998251|NCT00819234|O3|Outcome|Pramlintide 360 Mcg + Metreleptin 2.5 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 2.5 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
998252|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
998253|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998254|NCT00819234|O4|Outcome|Pramlintide 360 Mcg + Metreleptin 5.0 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 5.0 mg BID self administered SC for 52 Weeks, inclusive of DFA102.
998256|NCT00819234|O2|Outcome|Pramlintide 360 Mcg + Metreleptin 1.25 mg - Stable|Pramlintide 360 mcg BID plus Metreleptin 1.25 mg BID self administered SC. All participants entered treatment for 52 Weeks, inclusive of DFA102.
998257|NCT00819234|O1|Outcome|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998258|NCT00819234|E10|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 5.0 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 5.0 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998259|NCT00819234|E9|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Lower Pram|Participants who received 180 mcg pramlintide plus 2.5 mg metreleptin self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg pramlintide plus 2.5 mg metreleptin in the extension study for up to 52 Weeks, inclusive of DFA102. A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who received 180 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998260|NCT00819234|E8|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Metre Mono|Participants who received 5.0 mg metreleptin plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.A blinded pramlintide dose escalation/titration in the first week of treatment was performed for participants who had not received 360 mcg pramlintide in DFA102, to minimize nausea and/or vomiting.
998261|NCT00819234|E7|Reported Event|360 mcg Pramlintide + 5.0 mg Metreleptin - Prior Mono+5.0|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 5.0 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998262|NCT00819234|E6|Reported Event|360 mcg Pramlintide + 2.5 mg Metreleptin - Prior Mono+2.5|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 2.5 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998263|NCT00819234|E5|Reported Event|360 mcg Pramlintide + 1.25 mg Metreleptin - Prior Mono+1.25|Participants who received 360 mcg pramlintide plus placebo (monotherapy) self administered SC in the original study DFA102, and who consented to enter the extension study DFA102E, were treated with 360 mcg Pramlintide plus 1.25 metreleptin in this group of the extension study, for up to 52 Weeks, inclusive of DFA102.
998264|NCT00819234|E4|Reported Event|360 mcg Pramlintide + 5.0 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 5.0 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998265|NCT00819234|E3|Reported Event|360 mcg Pramlintide + 2.5 Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 2.5 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998266|NCT00819234|E2|Reported Event|360 mcg Pramlintide + 1.25mg Metreleptin - Stable|"Participants who received 360 mcg pramlintide plus 1.25 mg metreleptin self administered SC for up to 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E"
998267|NCT00819234|E1|Reported Event|Placebo - Stable|"Placebo matched to pramlintide BID plus placebo matched to metreleptin BID self administered subcutaneously (SC) for 52 Weeks, inclusive of DFA102.~Stable: same treatment regimen in both DFA102 and DFA102E."
998268|NCT00819091|B3|Baseline|Total|Total of all reporting groups
998269|NCT00819091|B2|Baseline|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998270|NCT00819091|B1|Baseline|Placebo|Matching placebo tablet taken orally once daily
998271|NCT00819091|P2|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998272|NCT00819091|P1|Participant Flow|Placebo|Matching placebo tablet taken orally once daily
998273|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998274|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998275|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998276|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998277|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998278|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998279|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998280|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998281|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998282|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998283|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998284|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998285|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998286|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998287|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998288|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998289|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998290|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998291|NCT00819091|O2|Outcome|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998292|NCT00819091|O1|Outcome|Placebo|Matching placebo tablet taken orally once daily
998293|NCT00819091|E2|Reported Event|Linagliptin 5.0 mg|Linagliptin 5.0 mg tablet taken orally once daily
998297|NCT00819052|B1|Baseline|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998298|NCT00819052|P2|Participant Flow|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998299|NCT00819052|P1|Participant Flow|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998300|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998301|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998302|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998303|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998304|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998305|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998306|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998307|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998308|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998309|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998310|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998311|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998312|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998313|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998314|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998315|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998316|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998317|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998318|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998319|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998320|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998321|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998322|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998323|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998324|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998325|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998326|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998327|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998328|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998329|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998330|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998331|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998332|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998333|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998334|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998335|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998336|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998337|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998338|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998339|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998340|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998341|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998342|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998343|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998344|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998345|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998346|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998347|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998348|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998349|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998350|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998351|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998352|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998353|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998354|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998565|NCT00818779|O2|Outcome|Amlodipine|5-10 mg amlodipine once daily
998355|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998356|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998357|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998358|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998359|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998360|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998361|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998362|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998363|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998364|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998365|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998366|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998367|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998368|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998369|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998370|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998371|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998372|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998373|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998374|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998375|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998376|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998377|NCT00819052|O3|Outcome|Nevirapine XR After Week 48|Patient remained on NVP XR after week 48
998378|NCT00819052|O2|Outcome|Nevirapine IR After Week 48|Patient remained on NVP IR after week 48
998379|NCT00819052|O1|Outcome|Nevirapine (NVP) IR / NVP XR|Nevirapine IR during first 48 weeks then switched to NVP XR
998380|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998381|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998382|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998383|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998384|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998385|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998386|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998387|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998388|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998389|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998390|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998391|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998392|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998393|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998394|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998395|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998396|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998397|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998398|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998399|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998400|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998401|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998402|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998403|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998404|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998405|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998406|NCT00819052|O2|Outcome|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998407|NCT00819052|O1|Outcome|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998408|NCT00819052|E2|Reported Event|Nevirapine Extended Release (NVP XR)|Nevirapine extended release 400 mg tablets given once daily
998409|NCT00819052|E1|Reported Event|Nevirapine Immediate Release (NVP IR)|Nevirapine immediate release 200 mg tablets given twice daily
998410|NCT00819039|B4|Baseline|Total|Total of all reporting groups
998411|NCT00819039|B3|Baseline|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998412|NCT00819039|B2|Baseline|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998413|NCT00819039|B1|Baseline|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998414|NCT00819039|P3|Participant Flow|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998415|NCT00819039|P2|Participant Flow|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998416|NCT00819039|P1|Participant Flow|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998417|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998418|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
998419|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998420|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
998421|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998422|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
998423|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998424|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
998425|NCT00819039|O2|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998426|NCT00819039|O1|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1
998427|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998428|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998429|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998430|NCT00819039|O3|Outcome|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998431|NCT00819039|O2|Outcome|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998432|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998433|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998434|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998435|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998436|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998437|NCT00819039|O1|Outcome|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998438|NCT00819039|E3|Reported Event|Part 2: Intravenous Ondansetron|In Study Part 2, particpants aged 6 months to 17 years received a single intravenous dose of ondansetron for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998439|NCT00819039|E2|Reported Event|Part 2: Oral Aprepitant|In Study Part 2, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998440|NCT00819039|E1|Reported Event|Part 1: Oral Aprepitant|In Study Part 1, participants aged 6 months to 17 years received a single oral dose of aprepitant for the treatment of post-operative nausea and vomiting (PONV) on Day 1.
998441|NCT00819013|B5|Baseline|Total|Total of all reporting groups
998442|NCT00819013|B4|Baseline|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998443|NCT00819013|B3|Baseline|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998444|NCT00819013|B2|Baseline|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998445|NCT00819013|B1|Baseline|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998446|NCT00819013|P4|Participant Flow|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998447|NCT00819013|P3|Participant Flow|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998448|NCT00819013|P2|Participant Flow|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998449|NCT00819013|P1|Participant Flow|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998450|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998451|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998452|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998453|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998454|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998455|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998456|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998457|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998458|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998459|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998460|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998461|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998462|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998463|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998464|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998465|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998466|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998467|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998468|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998469|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998470|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998471|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998472|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998473|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998474|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998475|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998476|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998477|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998478|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998479|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998480|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998481|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998482|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998483|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998484|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998485|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998486|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998487|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998488|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998489|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998490|NCT00819013|O4|Outcome|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998491|NCT00819013|O3|Outcome|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998492|NCT00819013|O2|Outcome|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998493|NCT00819013|O1|Outcome|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998494|NCT00819013|E4|Reported Event|Saline Placebo|Participants who received a 0.5 mL dose of placebo (saline) vaccine, on Day 0 and Day 30.
998495|NCT00819013|E3|Reported Event|ACAM FLU A Without Adjuvant|Participants who received 0.5 mL dose of ACAM FLU A vaccine without adjuvant, on Day 0 and Day 30.
998496|NCT00819013|E2|Reported Event|ACAM-FLU-A Adjuvanted With Stimulon® QS-21|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Stimulon QS 21, on Day 0 and Day 30.
998497|NCT00819013|E1|Reported Event|ACAM-FLU-A Adjuvanted With Alhydrogel|Participants who received a 0.5 mL dose of ACAM FLU A vaccine adjuvanted with Alhydrogel, on Day 0 and Day 30.
998498|NCT00818961|B1|Baseline|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998499|NCT00818961|P1|Participant Flow|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998500|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998501|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998502|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998503|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998504|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998505|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998506|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998507|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998508|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998509|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998510|NCT00818961|O1|Outcome|Hematopoietic Stem Cell Transplantation|All patients receive a hematopoietic stem cell transplant using one of two chemotherapy regimens based on disease type
998511|NCT00818961|E1|Reported Event|Hematopoietic Stem Cell Transplantation|All patients received a hematopoietic Stem Cell Transplantation as part of this clinical trial.
998512|NCT00818883|B3|Baseline|Total|Total of all reporting groups
998513|NCT00818883|B2|Baseline|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998514|NCT00818883|B1|Baseline|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998515|NCT00818883|P2|Participant Flow|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998516|NCT00818883|P1|Participant Flow|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998517|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998518|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998519|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998520|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998521|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998522|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998523|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998524|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998525|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998526|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998527|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998528|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998529|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998530|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998531|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998532|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998533|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998534|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998535|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998566|NCT00818779|O1|Outcome|Aliskiren|Aliskiren 150-300 mg once daily
998567|NCT00818779|E2|Reported Event|Amlodipine|5-10 mg amlodipine once daily
998568|NCT00818779|E1|Reported Event|Aliskiren|Aliskiren 150-300 mg once daily
998536|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998537|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998538|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998539|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998540|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998541|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998542|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998543|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998544|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998545|NCT00818883|O2|Outcome|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998546|NCT00818883|O1|Outcome|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998547|NCT00818883|E2|Reported Event|Azilsartan Medoxomil 40 mg + Hydrochlorothiazide 12.5 mg QD|"Azilsartan medoxomil 40 mg, tablets, orally, once daily and hydrochlorothiazide 12.5 mg, tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of hydrochlorothiazide will be increased for the remaining 4 weeks of treatment."
998548|NCT00818883|E1|Reported Event|Azilsartan Medoxomil 40 mg/Chlorthalidone 12.5 mg QD|"Azilsartan medoxomil 40 mg and chlorthalidone 12.5 mg combination tablet, orally, once daily and hydrochlorothiazide placebo-matching tablets, orally, once daily for up to 10 weeks.~For participants who do not achieve target blood pressure by Week 6, the dose of chlorthalidone will be increased for the remaining 4 weeks of treatment."
998549|NCT00818805|B1|Baseline|Entire Study Population|
998550|NCT00818805|P2|Participant Flow|Tranilast 0.5% First, Then Olopatadine Second|Patients received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye first, then received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye last.
998551|NCT00818805|P1|Participant Flow|Olopatadine 0.1% First, Then Tranilast Second|Patients received Olopatadine 0.1% one eye/ Placebo (Olopatadine) in contralateral eye first, then received Tranilast 0.5% one eye/ Placebo (Tranilast) in contralateral eye next
998552|NCT00818805|O4|Outcome|Placebo (Tranilast)|Placebo (Tranilast) in one eye in either the first or second period
998553|NCT00818805|O3|Outcome|Placebo (Olopatadine)|Placebo (Olopatadine) in one eye in either the first or second period
998554|NCT00818805|O2|Outcome|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
998555|NCT00818805|O1|Outcome|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
998556|NCT00818805|E4|Reported Event|Placebo (Tranilast) One Eye|Placebo (Tranilast) in one eye in either the first or second period
998557|NCT00818805|E3|Reported Event|Placebo (Olopatadine) One Eye|Placebo (Olopatadine) in one eye in either the first or second period
998558|NCT00818805|E2|Reported Event|Tranilast 0.5% One Eye|Tranilast 0.5% in one eye in either the first or second period
998559|NCT00818805|E1|Reported Event|Olopatadine 0.1% One Eye|Olopatadine 0.1% in one eye in either the first or second period
998560|NCT00818779|B3|Baseline|Total|Total of all reporting groups
998561|NCT00818779|B2|Baseline|Amlodipine|5-10 mg amlodipine once daily
998562|NCT00818779|B1|Baseline|Aliskiren|Aliskiren 150-300 mg once daily
998563|NCT00818779|P2|Participant Flow|Amlodipine|5-10 mg amlodipine once daily
998564|NCT00818779|P1|Participant Flow|Aliskiren|Aliskiren 150-300 mg once daily
998570|NCT00818766|B2|Baseline|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998571|NCT00818766|B1|Baseline|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998572|NCT00818766|P2|Participant Flow|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998573|NCT00818766|P1|Participant Flow|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998574|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998575|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998576|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998577|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998578|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998579|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998580|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998581|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998582|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998583|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998584|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998585|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998586|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998587|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998588|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998589|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998590|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998591|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998592|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998593|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998594|NCT00818766|O2|Outcome|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998595|NCT00818766|O1|Outcome|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998596|NCT00818766|E2|Reported Event|Placebo|Placebo: Participants received IV placebo for 48 hours post-operatively or until all chest tubes were removed, whichever occurred first.
998597|NCT00818766|E1|Reported Event|Antibiotic|Cefazolin or vancomycin: Cefazolin IV every eight hours post-operatively for 48 hours or until all chest tubes were removed, whichever occurred first. Participants under 80 kg received 1 gram of cefazolin and participants who were 80 kg or more received 2 grams of cefazolin. Participants who were cephalosporin-allergic received 1 gram of vancomycin every 12 hours for 48 hours or until all chest tubes were removed, whichever occurred first.
998598|NCT00818753|B4|Baseline|Total|Total of all reporting groups
998599|NCT00818753|B3|Baseline|Heparin|Unfractionated heparin administered during intervention
998600|NCT00818753|B2|Baseline|Dabigatran 150mg Bis in Die (BID)|
998601|NCT00818753|B1|Baseline|Dabigatran 110mg Bis in Die (BID)|
998602|NCT00818753|P3|Participant Flow|Heparin|Unfractionated heparin administered during intervention
998603|NCT00818753|P2|Participant Flow|Dabigatran 150mg Bis in Die (BID)|
998604|NCT00818753|P1|Participant Flow|Dabigatran 110mg Bis in Die (BID)|
998605|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
998606|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
998607|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
998608|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
998609|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
998610|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
998611|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
998612|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
998613|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
998614|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
998615|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
998616|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
998617|NCT00818753|O3|Outcome|Heparin|Unfractionated heparin administered during intervention
998618|NCT00818753|O2|Outcome|Dabigatran 150mg Bis in Die (BID)|
998619|NCT00818753|O1|Outcome|Dabigatran 110mg Bis in Die (BID)|
998620|NCT00818753|E3|Reported Event|Heparin|Unfractionated heparin administered during intervention
998621|NCT00818753|E2|Reported Event|Dabigatran 150mg Bis in Die (BID)|
998622|NCT00818753|E1|Reported Event|Dabigatran 110mg Bis in Die (BID)|
998623|NCT00818662|B5|Baseline|Total|Total of all reporting groups
998624|NCT00818662|B4|Baseline|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks~Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
998625|NCT00818662|B3|Baseline|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks~Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
998626|NCT00818662|B2|Baseline|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998627|NCT00818662|B1|Baseline|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998628|NCT00818662|P4|Participant Flow|Placebo 2 mL/kg|"0.25% human albumin solution infused at 2 mL/kg/2weeks~Placebo solution: 2 mL/kg : 0.25% human albumin solution infused at 2 mL/kg/2weeks for 70 weeks"
998629|NCT00818662|P3|Participant Flow|Placebo 4 mL/kg|"0.25% human albumin solution infused at 4 mL/kg/2weeks~Placebo solution: 4 mL/kg : 0.25% human albumin solution infused at 4 mL/kg/2weeks for 70 weeks"
998630|NCT00818662|P2|Participant Flow|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998631|NCT00818662|P1|Participant Flow|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998632|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998633|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998634|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998635|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998636|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
1007082|NCT00798161|B8|Baseline|Total|Total of all reporting groups
998637|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998638|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998639|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998640|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998641|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998642|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998643|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998644|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998645|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998646|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998647|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998648|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998649|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998650|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998651|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998652|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998653|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998654|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998655|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998656|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998657|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998658|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998659|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998660|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998661|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998662|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998663|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998664|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
1008164|NCT00796120|B3|Baseline|Total|Total of all reporting groups
998665|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998666|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998667|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998668|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998669|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998670|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998671|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998672|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998673|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998674|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998675|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998676|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998677|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998678|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998679|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998680|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998681|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998682|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998683|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998684|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998685|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998686|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998687|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998688|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998689|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998690|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998691|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998692|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998693|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998694|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998695|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998696|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998697|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
1012495|NCT00786565|O2|Outcome|Akreos Adapt|Akreos Adapt Intraocular Lens
998698|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998699|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998700|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998701|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998702|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998703|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998704|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998705|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998706|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998707|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|All participants who received the 2 mL/kg or 4 mL/kg placebo solution Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks
998708|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks"
998709|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks"
998710|NCT00818662|O3|Outcome|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998711|NCT00818662|O2|Outcome|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998712|NCT00818662|O1|Outcome|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998713|NCT00818662|E3|Reported Event|Placebo 2 mL/kg or 4 mL/kg|"All participants who received the 2 mL/kg or 4 mL/kg placebo solution~Placebo solution: 2 mL/kg or 4 mL/kg : 0.25% human albumin solution infused every 2weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998714|NCT00818662|E2|Reported Event|IGIV, 10% 200mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 200 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998715|NCT00818662|E1|Reported Event|IGIV, 10% 400mg/kg|"Immune Globulin Intravenous (Human), 10% (IGIV, 10%)~Immune Globulin Intravenous (Human), 10% (IGIV, 10%) : 400 mg/kg bodyweight every 2 weeks for 70 weeks~Adverse Events That Occurred During or After Treatment"
998716|NCT00818649|B1|Baseline|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
998717|NCT00818649|P1|Participant Flow|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
998718|NCT00818649|O1|Outcome|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
998719|NCT00818649|O1|Outcome|Velcade + Vorinostat in MDS and AML|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
998720|NCT00818649|O1|Outcome|Evaluable Patients|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment continued for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
998721|NCT00818649|E1|Reported Event|Velcade + Vorinostat|"This is a phase II two stage single arm study combining Velcade on days 1, 4, 8, and 11 plus oral Vorinostat days 1-14 of a 21 days cycle. Treatment will continue for a total of 3 treatment cycles.~vorinostat : 400 mg orally (po) every day on days 1-14 of a 21 day cycle~bortezomib : 1.3mg/m^2 via peripheral subcutaneous administration on day 1, 4, 8, 11 of a 21 day cycle"
998722|NCT00818623|B9|Baseline|Total|Total of all reporting groups
998723|NCT00818623|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998724|NCT00818623|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
1015756|NCT00777179|O2|Outcome|Placebo|Matching Placebo
998725|NCT00818623|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998726|NCT00818623|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998727|NCT00818623|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998728|NCT00818623|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998729|NCT00818623|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998730|NCT00818623|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998731|NCT00818623|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998732|NCT00818623|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998733|NCT00818623|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998734|NCT00818623|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998735|NCT00818623|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998736|NCT00818623|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998737|NCT00818623|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998738|NCT00818623|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998739|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998740|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998741|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998742|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998743|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998744|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998745|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998746|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998747|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998748|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998749|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998750|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998751|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998752|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998753|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998754|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998755|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998756|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998757|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998758|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998759|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998760|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998761|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998762|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998763|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998764|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998765|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998766|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998767|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998768|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998769|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998770|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998771|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998772|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998773|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998774|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998775|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998776|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998777|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998778|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998779|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998780|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998781|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998782|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998783|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998784|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998785|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998786|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998787|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998788|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998789|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998790|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998791|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998792|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998793|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
1016003|NCT00776230|B4|Baseline|Total|Total of all reporting groups
998794|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998795|NCT00818623|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998796|NCT00818623|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998797|NCT00818623|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998798|NCT00818623|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998799|NCT00818623|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998800|NCT00818623|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998801|NCT00818623|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998802|NCT00818623|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998803|NCT00818623|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
998804|NCT00818623|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
998805|NCT00818623|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
998806|NCT00818623|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
998807|NCT00818623|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
998808|NCT00818623|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
998809|NCT00818623|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
998810|NCT00818623|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
998811|NCT00818519|B3|Baseline|Total|Total of all reporting groups
998812|NCT00818519|B2|Baseline|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998813|NCT00818519|B1|Baseline|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998814|NCT00818519|P2|Participant Flow|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998815|NCT00818519|P1|Participant Flow|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998816|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998817|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998818|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998819|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998820|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998821|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998822|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998823|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998824|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998825|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998826|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998827|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998828|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998829|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998830|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998831|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998832|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998833|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998834|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998835|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
1017776|NCT00772603|O1|Outcome|2400mg/Day SPN-804|2400mg SPN-804 once daily
998836|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998837|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998838|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998839|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998840|NCT00818519|O2|Outcome|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998841|NCT00818519|O1|Outcome|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998842|NCT00818519|E2|Reported Event|Placebo|The participants of the placebo group received inert but identical-appearing, color-matched tablets.
998843|NCT00818519|E1|Reported Event|EE20/Drospirenone (YAZ, BAY86-5300)|In the active treatment group, participants received 24 consecutive days of active tablets followed by 4 consecutive days of inactive tablets. The active tablet contained 3 mg DRSP (Drospirenone) and 20µg EE (Ethinyl estradiol).
998844|NCT00818454|B1|Baseline|Entire Study Population|Participants randomized to crossover part at randomization 1
998845|NCT00818454|P4|Participant Flow|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
998846|NCT00818454|P3|Participant Flow|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
998847|NCT00818454|P2|Participant Flow|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
998848|NCT00818454|P1|Participant Flow|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
998849|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
998850|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
998851|NCT00818454|O2|Outcome|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
998852|NCT00818454|O1|Outcome|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
998853|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998854|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998855|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998856|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998857|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998858|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998859|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998860|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998861|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998862|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998863|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998864|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998865|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998866|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998867|NCT00818454|O2|Outcome|Combivent CFC|Combivent Chlorofluorocarbon
998868|NCT00818454|O1|Outcome|Albuterol HFA|Albuterol Hydrofluoroalkene
998869|NCT00818454|E4|Reported Event|Combivent Respimat|Combivent Respimat (contains the effective dose of albuterol)
998870|NCT00818454|E3|Reported Event|Placebo Respimat|Placebo Respimat (matching Combivent Respimat)
998871|NCT00818454|E2|Reported Event|Combivent CFC First, Then Albuterol HFA|Combivent Chlorofluorocarbon, Albuterol Hydrofluoroalkene
998872|NCT00818454|E1|Reported Event|Albuterol HFA First, Then Combivent CFC|Albuterol Hydrofluoroalkene, Combivent Chlorofluorocarbon
998873|NCT00818441|B3|Baseline|Total|Total of all reporting groups
998874|NCT00818441|B2|Baseline|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998875|NCT00818441|B1|Baseline|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998939|NCT00818259|P5|Participant Flow|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
999111|NCT00817479|P2|Participant Flow|Dexamethasone|20 mg dexamethasone IV push
999112|NCT00817479|P1|Participant Flow|Placebo|Placebo [saline]
998876|NCT00818441|P2|Participant Flow|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998877|NCT00818441|P1|Participant Flow|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998878|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998879|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998880|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998881|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998882|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998883|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
999089|NCT00817778|O1|Outcome|Experimental|AZD1656
999090|NCT00817778|O1|Outcome|Experimental|AZD1656
998884|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998885|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998886|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998887|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998888|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998889|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998890|NCT00818441|O2|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998891|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
999091|NCT00817778|O1|Outcome|Experimental|AZD1656
999092|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
998892|NCT00818441|O1|Outcome|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998893|NCT00818441|O1|Outcome|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998894|NCT00818441|E2|Reported Event|Dacomitinib: Cohort B|Participants who had human epidermal growth factor receptor 2 (HER2) gene amplification or HER2 mutation, advanced non-small cell lung cancer (NSCLC) of any histology and had received prior chemotherapy or prior EGFR-targeted therapy, received dacomitinib 45 mg or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Participants who had not received prior therapy for advanced NSCLC, received 30 mg daily and participants who had received prior systemic therapy for advanced NSCLC, received 45 mg daily as starting dose. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per judgment of the investigator. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg.
998895|NCT00818441|E1|Reported Event|Dacomitinib: Cohort A|Participants who had adenocarcinoma of lung, had not received prior systemic therapy and were either nonsmokers, former light smokers or were known to have an epidermal growth factor receptor (EGFR)-activating mutation, received dacomitinib 45 milligram (mg) or 30 mg tablet orally daily in cycles of 28 days until progression of disease, unacceptable toxicity, or participant withdrawal. Dose escalated to 45 mg in participants after at least 8 weeks of therapy who had started treatment at 30 mg and were tolerating treatment for at least 4 consecutive weeks as per investigator's judgment. Dose modifications for treatment-related toxicity were allowed for up to 2 dose reductions (to 30 mg and then to 15 mg) if the participant started at 45 mg. Dose interruption for treatment-related toxicity was also allowed as per investigator's discretion.
998896|NCT00818389|B3|Baseline|Total|Total of all reporting groups
998897|NCT00818389|B2|Baseline|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
998898|NCT00818389|B1|Baseline|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
998899|NCT00818389|P2|Participant Flow|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
998900|NCT00818389|P1|Participant Flow|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
998901|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
998902|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
999093|NCT00817778|O1|Outcome|Experimental|AZD1656
999094|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
998903|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
998904|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
998905|NCT00818389|O2|Outcome|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
998906|NCT00818389|O1|Outcome|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
998907|NCT00818389|E2|Reported Event|Placebo + Riluzole|Participants randomized to placebo + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Matching placebo was supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule in the a.m. and 2 capsules in the p.m). Paired sham dosage modifications were made for placebo subjects, i.e. all subjects randomized to placebo were 'paired' with a lithium subject and underwent identical dosage changes to maintain blinding.
998908|NCT00818389|E1|Reported Event|Lithium + Riluzole|Subjects randomized to lithium + riluzole were required to be taking riluzole 50 milligrams (mg) twice per day at least 30 days prior to the screening visit and during the trial. Lithium carbonate and matching placebo were supplied in 150 mg capsules. Dosing started at 450 mg/day (1 capsule taken in the a.m. and 2 capsules taken in the p.m.), titrated to maintain plasma lithium levels of 0.4 - 0.8 milliequivalent per liter (mEq/L). The number of capsules taken per day was titrated individually for each patient based on blood testing to maintain plasma levels of lithium = 04. - 0.8 milliequivalent per liter (mEq/L).
998909|NCT00818337|B1|Baseline|Aspirin 81mg|Aspirin 81mg at baseline
998910|NCT00818337|P1|Participant Flow|Aspirin 81mg|Aspirin 81mg at baseline
998911|NCT00818337|O1|Outcome|Aspirin 325 mg|Participants who were aspirin resistant who were increased to aspirin 325 mg
998912|NCT00818337|O1|Outcome|Aspirin 81 mg|Aspirin 81 mg at baseline
998913|NCT00818337|E1|Reported Event|Aspirin 81mg|Aspirin 81mg at baseline
998914|NCT00818324|B1|Baseline|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
998915|NCT00818324|P1|Participant Flow|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
998916|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
998917|NCT00818324|O1|Outcome|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
998918|NCT00818324|E1|Reported Event|2% Rebamipide Group|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 52 weeks
998919|NCT00818272|B1|Baseline|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
998920|NCT00818272|P1|Participant Flow|Infliximab|Participants with confirmed diagnosis of severe active Crohn's disease (CD) and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as intravenous (IV) infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC): 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
998921|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
998922|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
999095|NCT00817778|O1|Outcome|Experimental|AZD1656
998923|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
998924|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
998925|NCT00818272|O1|Outcome|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
998926|NCT00818272|E1|Reported Event|Infliximab|Participants with confirmed diagnosis of severe active CD and participants suffering from fistulae who do not respond sufficiently to a complete and adequate therapy with a conventional treatment received infliximab administration as IV infusion over a period of two hours. Dosage and infusion intervals were employed in accordance to the SmPC: 5 mg/kg body weight at week 0 with additional infusions of 5 mg/kg at week 2 and week 6 after the initial dose, followed by infusions every 8 weeks (maintenance) or if signs and symptoms of the disease recur (readministration).
998927|NCT00818259|B8|Baseline|Total|Total of all reporting groups
998928|NCT00818259|B7|Baseline|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998929|NCT00818259|B6|Baseline|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998930|NCT00818259|B5|Baseline|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998931|NCT00818259|B4|Baseline|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998932|NCT00818259|B3|Baseline|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998933|NCT00818259|B2|Baseline|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998934|NCT00818259|B1|Baseline|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998935|NCT00818259|P9|Participant Flow|Part V-Additional Enrollers|Additional participants were enrolled in Part V. Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998936|NCT00818259|P8|Participant Flow|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998937|NCT00818259|P7|Participant Flow|Part IV-Additional Enrollers|Additional participants were enrolled in Part IV. Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998938|NCT00818259|P6|Participant Flow|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
999096|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
999097|NCT00817778|O1|Outcome|Experimental|AZD1656
999098|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
998940|NCT00818259|P4|Participant Flow|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998941|NCT00818259|P3|Participant Flow|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998942|NCT00818259|P2|Participant Flow|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998943|NCT00818259|P1|Participant Flow|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant intravenous (IV) at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg orally (PO), prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998944|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998945|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998946|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998947|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998948|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998949|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998950|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998951|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998952|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998953|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998954|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998955|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998956|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998957|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998958|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999099|NCT00817778|O1|Outcome|Experimental|AZD1656
999100|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
998959|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998960|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998961|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998962|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998963|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998964|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998965|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998966|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998967|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998968|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998969|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998970|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998971|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998972|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998973|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998974|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998975|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998976|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999101|NCT00817778|O1|Outcome|Experimental|AZD1656
999102|NCT00817778|E2|Reported Event|Placebo Comparator|Placebo
998977|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998978|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998979|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998980|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998981|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998982|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998983|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998984|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998985|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998986|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998987|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998988|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
998989|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998990|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998991|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998992|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998993|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998994|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
998995|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
999103|NCT00817778|E1|Reported Event|Experimental|AZD1656
998996|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998997|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998998|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
998999|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999000|NCT00818259|O7|Outcome|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999001|NCT00818259|O6|Outcome|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
999002|NCT00818259|O5|Outcome|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
999003|NCT00818259|O4|Outcome|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999004|NCT00818259|O3|Outcome|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999005|NCT00818259|O2|Outcome|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999006|NCT00818259|O1|Outcome|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999007|NCT00818259|E7|Reported Event|Part V-fosaprepitant Regimen|Day 1, fosaprepitant, IV at a dose of 3 mg/kg prior to chemotherapy for participants 6 months to <12 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999008|NCT00818259|E6|Reported Event|Part IV-aprepitant Regimen|Day 1, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; Birth to <1 month of age - 0.75 mg/kg; Days 2 and 3, aprepitant, PO, prior to chemotherapy at the dosing regimens listed for the following age ranges: 4 months to <12 years of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; Birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care. The use of dexamethasone IV is optional with the exception of the birth to one year old cohort.
999009|NCT00818259|E5|Reported Event|Part III-ondansetron|Ondansetron administered IV per local standard of care on Days 1, 2, and 3 prior to chemotherapy for participants from birth to <12 years of age. The use of IV dexamethasone is optional with the exception of the birth to one year old cohort.
999010|NCT00818259|E4|Reported Event|Part IIB-aprepitant 125 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 2 years to <12 years of age - 74 mg/m^2; 6 months to <2 years of age - 1.3 mg/kg; 4 months to <6 months of age - 3.0 mg/kg; 1 month to <4 months of age - 1.5 mg/kg; birth to <1 month of age - 0.75 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999011|NCT00818259|E3|Reported Event|Part IIA-aprepitant 80 mg Equiv.|Day 1, aprepitant PO prior to chemotherapy at the dosing regimens listed for the following age ranges: 6 months to <12 years of age - 47 mg/m^2; 4 months to <6 months of age - 2.0 mg/kg; 1 month to <4 months of age - 1.0 mg/kg; birth to <1 month of age - 0.5 mg/kg. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999012|NCT00818259|E2|Reported Event|Part IB-fosaprepitant 150 mg|Day 1, fosaprepitant, IV at a dose of 150 mg, prior to chemotherapy for participants 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999013|NCT00818259|E1|Reported Event|Part IA-fosaprepitant 115 mg/Aprepitant|Day 1, fosaprepitant IV at a dose of 115 mg and Days 2 and 3, aprepitant 80 mg PO, prior to chemotherapy for participants from 12 to 17 years of age. Participants also receive ondansetron IV as per local standard of care, with or without dexamethasone IV.
999014|NCT00818246|B1|Baseline|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
999104|NCT00817531|B1|Baseline|Dasatinib|Patients took Dasatinib 100mg daily
999015|NCT00818246|P1|Participant Flow|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
999016|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
999017|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
999018|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
999019|NCT00818246|O1|Outcome|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
999020|NCT00818246|E1|Reported Event|Sham-treated; LED-treated (Split-face Study)|one side of the face was treated with a Sham light and the other half with a light emitting diode (LED) at 660 nm three times weekly for four consecutive weeks (12 treatments)on the experimental periorbital area.
999021|NCT00818207|B3|Baseline|Total|Total of all reporting groups
999022|NCT00818207|B2|Baseline|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999023|NCT00818207|B1|Baseline|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999024|NCT00818207|P2|Participant Flow|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999025|NCT00818207|P1|Participant Flow|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999026|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999027|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999028|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999029|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999030|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999031|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999032|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999033|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999034|NCT00818207|O2|Outcome|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999035|NCT00818207|O1|Outcome|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999036|NCT00818207|E2|Reported Event|No Reimbursement for SCT|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group received no reimbursement for the SCT used during the 26-week period following randomization and had to pay for therapies out-of-pocket.
999105|NCT00817531|P1|Participant Flow|Dasatinib|Patients took Dasatinib 100mg daily
999106|NCT00817531|O1|Outcome|Dasatinib|Dasatinib 100 mg once daily
999107|NCT00817531|E1|Reported Event|Dasatinib|Patients took Dasatinib 100mg daily
999037|NCT00818207|E1|Reported Event|Reimbursement for Smoking Cessation Therapy (SCT)|Participants used SCT of their choice, either pharmacological or non-pharmacological, or they could have chosen to use no SCT during the study. Participants in this group were fully reimbursed for the SCT used during the 26-week period following randomization.
999038|NCT00818168|B1|Baseline|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999039|NCT00818168|P1|Participant Flow|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999040|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999041|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999042|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999043|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999044|NCT00818168|O1|Outcome|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999045|NCT00818168|E1|Reported Event|Infliximab|Subjects with ankylosing spondylitis who were treated with infliximab. The dosage and infusion intervals were employed in accordance to the Summary of Product Characteristics (SmPC)
999046|NCT00818116|B1|Baseline|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
999047|NCT00818116|P1|Participant Flow|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
999048|NCT00818116|O1|Outcome|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
999049|NCT00818116|E1|Reported Event|ReSTOR Aspheric|Implantation with the AcrySof ReSTOR Aspheric Intraocular Lens (IOL)
999050|NCT00817999|B3|Baseline|Total|Total of all reporting groups
999051|NCT00817999|B2|Baseline|Maintenance Dose|
999052|NCT00817999|B1|Baseline|Loading Dose|
999053|NCT00817999|P2|Participant Flow|Maintenance Dose|Healthy volunteers who received clopidogrel 75 mg/day for 7 days during each period with or without grapefruit juice.
999054|NCT00817999|P1|Participant Flow|Loading Dose|Healthy volunteers who received a 300 mg dose of clopidogrel with or without grapefruit juice.
999055|NCT00817999|O4|Outcome|Maintenance Dose Without Grapefruit Juice|
999056|NCT00817999|O3|Outcome|Loading Dose Without Grapefruit Juice|
999057|NCT00817999|O2|Outcome|Maintenance Dose With Grapefruit Juice|
999058|NCT00817999|O1|Outcome|Loading Dose With Grapefruit Juice|
999059|NCT00817999|E2|Reported Event|Maintenance Dose|
999060|NCT00817999|E1|Reported Event|Loading Dose|
999061|NCT00817843|B1|Baseline|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
999062|NCT00817843|P2|Participant Flow|Simvastatin/Ezetimibe 10/10mg First, Then Simvastatin 80mg|First 6 weeks of treatment with simvastatin/ezetimibe 10/10 mg combination with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin 80 mg and placebo
999063|NCT00817843|P1|Participant Flow|Simvastatin 80mg First, Then Simvastatin/Ezetimibe 10/10mg|First 6 weeks of treatment with simvastatin 80 mg with placebo, followed by 6 weeks of placebo controlled washout and 6 weeks of simvastatin/ezetimibe 10/10 mg combination and placebo
999064|NCT00817843|O2|Outcome|Simvastatin 10 mg / Ezetimibe 10 mg|6 weeks of treatment with simvastatin 10 mg / ezetimibe 10 mg
999065|NCT00817843|O1|Outcome|Simvastatin 80 mg|6 weeks of treatment with simvastatin 80 mg
999066|NCT00817843|E1|Reported Event|Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg|All patients were randomized to receive either Simvastatin 80mg or Simvastatin/Ezetimibe 10/10mg during this period
999067|NCT00817804|B3|Baseline|Total|Total of all reporting groups
999068|NCT00817804|B2|Baseline|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
999069|NCT00817804|B1|Baseline|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
999070|NCT00817804|P2|Participant Flow|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
999071|NCT00817804|P1|Participant Flow|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
999072|NCT00817804|O2|Outcome|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
999073|NCT00817804|O1|Outcome|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
999074|NCT00817804|E2|Reported Event|Conventional First|Experimental Study device (used as the experimental device) second in the cross-over study
999075|NCT00817804|E1|Reported Event|V60 First|Experimental Study device (used as the experimental device) first in the cross-over study
999076|NCT00817778|B3|Baseline|Total|Total of all reporting groups
999077|NCT00817778|B2|Baseline|Placebo Comparator|Placebo
999078|NCT00817778|B1|Baseline|Experimental|AZD1656
999079|NCT00817778|P2|Participant Flow|Placebo Comparator|Placebo
999080|NCT00817778|P1|Participant Flow|Experimental|AZD1656
999081|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
999082|NCT00817778|O1|Outcome|Experimental|AZD1656
999083|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
999084|NCT00817778|O1|Outcome|Experimental|AZD1656
999085|NCT00817778|O2|Outcome|Placebo Comparator|Placebo
999086|NCT00817778|O1|Outcome|Experimental|AZD1656
999087|NCT00817778|O1|Outcome|Experimental|AZD1656
999088|NCT00817778|O1|Outcome|Experimental|AZD1656
999117|NCT00817479|E2|Reported Event|Dexamethasone|20 mg dexamethasone IV push
999118|NCT00817479|E1|Reported Event|Placebo|Placebo [saline]
999119|NCT00817219|B1|Baseline|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999120|NCT00817219|P1|Participant Flow|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999121|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999122|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999123|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999124|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999125|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999126|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999127|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999128|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999129|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999130|NCT00817219|O1|Outcome|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999131|NCT00817219|E1|Reported Event|TACLONEX Ointment|TACLONEX (Calcipotriol and betamethasone dipropionate) ointment applied once daily to psoriasis on the trunk/limbs for 4 weeks
999132|NCT00817206|B3|Baseline|Total|Total of all reporting groups
999133|NCT00817206|B2|Baseline|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
999134|NCT00817206|B1|Baseline|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
999135|NCT00817206|P2|Participant Flow|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
999136|NCT00817206|P1|Participant Flow|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
999137|NCT00817206|O2|Outcome|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
999138|NCT00817206|O1|Outcome|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
999139|NCT00817206|E2|Reported Event|Prograf (Tacrolimus)|"Prograf® capsules, twice daily (Astellas Pharma US, Deerfield IL)~Prograf: Oral prograf doses will be given BID (in the morning and evening), to maintain trough levels of 5- 15 ng/mL. Prograf capsules (tacrolimus) capsules, twice daily oral, provided in 0.5 mg, 1 mg, and 5 mg capsules."
999140|NCT00817206|E1|Reported Event|LCP-Tacro|"LCP-Tacro tablets™, once daily (LifeCycle Pharma A/S, Hoersholm DK)~LCP-Tacro: LCP-Tacro tablets will be administered orally QD, at the same time in the morning to maintain trough levels at 5-15 ng/ML. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels. LCP-Tarco (tacrolimus) tablets provided in 0.5 mg, 1 mg, 2 mg, and 5 mg tablets."
999141|NCT00816907|B3|Baseline|Total|Total of all reporting groups
999142|NCT00816907|B2|Baseline|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
999143|NCT00816907|B1|Baseline|Placebo|Matching over-encapsulated placebo pills
999144|NCT00816907|P2|Participant Flow|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
999145|NCT00816907|P1|Participant Flow|Placebo|Matching over-encapsulated placebo pills
999146|NCT00816907|O2|Outcome|Metformin|
999147|NCT00816907|O1|Outcome|Placebo|
999148|NCT00816907|O2|Outcome|Metformin|
999149|NCT00816907|O1|Outcome|Placebo|
999150|NCT00816907|O2|Outcome|Metformin|
999151|NCT00816907|O1|Outcome|Placebo|
999152|NCT00816907|O2|Outcome|Metformin|
999153|NCT00816907|O1|Outcome|Placebo|
999154|NCT00816907|O2|Outcome|Metformin|
999155|NCT00816907|O1|Outcome|Placebo|
999156|NCT00816907|O2|Outcome|Metformin|
999157|NCT00816907|O1|Outcome|Placebo|
999158|NCT00816907|O2|Outcome|Metformin|
999159|NCT00816907|O1|Outcome|Placebo|
999160|NCT00816907|O2|Outcome|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
999161|NCT00816907|O1|Outcome|Placebo|Matching over-encapsulated placebo pills
1019363|NCT00771264|P1|Participant Flow|Urgent PC|
999162|NCT00816907|E2|Reported Event|Metformin|Metformin 500 mg pills over-encapsulated up to 4 pills daily as tolerated
999163|NCT00816907|E1|Reported Event|Placebo|Matching over-encapsulated placebo pills
999164|NCT00816829|B3|Baseline|Total|Total of all reporting groups
999165|NCT00816829|B2|Baseline|Fenofibrate|Fenofibrate 145 mg
999166|NCT00816829|B1|Baseline|Placebo|Placebo
999167|NCT00816829|P2|Participant Flow|Fenofibrate|Fenofibrate 145 mg
999168|NCT00816829|P1|Participant Flow|Placebo|Placebo
999169|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999170|NCT00816829|O1|Outcome|Placebo|Placebo
999171|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999172|NCT00816829|O1|Outcome|Placebo|Placebo
999173|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999174|NCT00816829|O1|Outcome|Placebo|Placebo
999175|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999176|NCT00816829|O1|Outcome|Placebo|Placebo
999177|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999178|NCT00816829|O1|Outcome|Placebo|Placebo
999179|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999180|NCT00816829|O1|Outcome|Placebo|Placebo
999181|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999182|NCT00816829|O1|Outcome|Placebo|Placebo
999183|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999184|NCT00816829|O1|Outcome|Placebo|Placebo
999185|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999186|NCT00816829|O1|Outcome|Placebo|Placebo
999187|NCT00816829|O2|Outcome|Fenofibrate|Fenofibrate 145 mg
999188|NCT00816829|O1|Outcome|Placebo|Placebo
999189|NCT00816829|E2|Reported Event|Fenofibrate|Fenofibrate 145 mg
999190|NCT00816829|E1|Reported Event|Placebo|Placebo
999191|NCT00816777|B3|Baseline|Total|Total of all reporting groups
999192|NCT00816777|B2|Baseline|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999193|NCT00816777|B1|Baseline|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999194|NCT00816777|P2|Participant Flow|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999195|NCT00816777|P1|Participant Flow|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999196|NCT00816777|O2|Outcome|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999197|NCT00816777|O1|Outcome|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999198|NCT00816777|E2|Reported Event|Chemotherapy|"Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999199|NCT00816777|E1|Reported Event|Chemoembolization|"Chemoembolization with Irinotecan Bead in combination with Intravenous Chemotherapy Group (test arm)~Chemoembolization with irinotecan Bead: Intra arterial chemoembolization using Irinotecan Bead 100mg irinotecan per procedure in combination with irinotecan monotherapy 250mg/m2 alternating on a 3 weekly schedule~Irinotecan: Irinotecan monotherapy: 250mg/m2 repeated every 3 weeks"
999200|NCT00816595|B3|Baseline|Total|Total of all reporting groups
999201|NCT00816595|B2|Baseline|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
999202|NCT00816595|B1|Baseline|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
999203|NCT00816595|P2|Participant Flow|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
999204|NCT00816595|P1|Participant Flow|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
999205|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
999206|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
999207|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
999208|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
999209|NCT00816595|O2|Outcome|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
999210|NCT00816595|O1|Outcome|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.
999211|NCT00816595|E2|Reported Event|Arm B: Pentostatin, Cyclophosphamide, and Rituximab|"Patients receive 100 mg rituximab IV over 2-4 hours on day 1 and 375 mg/m^2 on day 2 of course 1 and 375 mg/m^2 on day 1 of courses 2-6. They receive 2 mg/m^2 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 1. Patients also receive 6 mg pegfilgrastim SC on day 2. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
999212|NCT00816595|E1|Reported Event|Arm A: Pentostatin, Cyclophosphamide, Rituximab, and Avastin|"Patients receive 15 mg/kg bevacizumab IV over 30-90 minutes on day 1 of courses 1-5 and on days 1, 22, and 43 of course 6; 375 mg/m^2 rituximab IV over 2-4 hours on days 2 and 3 of course 1 and on day 1 of courses 2-6; and 2 mg/m^3 pentostatin IV over 30 minutes and 600 mg/m^2 cyclophosphamide IV over 30 minutes on day 2 of course 1 and on day 1 of courses 2-6. Patients also receive 6 mg pegfilgrastim subcutaneously (SC) on day 3 of course 1 and on day 2 of courses 2-6. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV pegfilgrastim: Given subcutaneously rituximab: Given IV cyclophosphamide: Given IV pentostatin: Given IV"
999213|NCT00816556|B4|Baseline|Total|Total of all reporting groups
999214|NCT00816556|B3|Baseline|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999215|NCT00816556|B2|Baseline|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999216|NCT00816556|B1|Baseline|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999217|NCT00816556|P3|Participant Flow|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999218|NCT00816556|P2|Participant Flow|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999219|NCT00816556|P1|Participant Flow|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999220|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999221|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999222|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999223|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999224|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999225|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999569|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999226|NCT00816556|O3|Outcome|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999227|NCT00816556|O2|Outcome|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999228|NCT00816556|O1|Outcome|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999229|NCT00816556|E3|Reported Event|Placebo|Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999230|NCT00816556|E2|Reported Event|Estradiol|Estradiol valerate 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999231|NCT00816556|E1|Reported Event|Estriol|Estriol 10 micrograms added to Vanicream Lite 0.5 grams applied to vaginal introitus daily for two weeks and then twice weekly for 10 weeks
999232|NCT00816400|B10|Baseline|Total|Total of all reporting groups
999233|NCT00816400|B9|Baseline|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999234|NCT00816400|B8|Baseline|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999235|NCT00816400|B7|Baseline|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999236|NCT00816400|B6|Baseline|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999237|NCT00816400|B5|Baseline|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999238|NCT00816400|B4|Baseline|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999239|NCT00816400|B3|Baseline|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999240|NCT00816400|B2|Baseline|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999241|NCT00816400|B1|Baseline|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999242|NCT00816400|P9|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999243|NCT00816400|P8|Participant Flow|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999244|NCT00816400|P7|Participant Flow|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999245|NCT00816400|P6|Participant Flow|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999246|NCT00816400|P5|Participant Flow|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999247|NCT00816400|P4|Participant Flow|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999248|NCT00816400|P3|Participant Flow|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999249|NCT00816400|P2|Participant Flow|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999271|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999570|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999250|NCT00816400|P1|Participant Flow|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999251|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999252|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999253|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999254|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999255|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999256|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999257|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999258|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999259|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999260|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999261|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999262|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999263|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999264|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999265|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999266|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999267|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999268|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999269|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999270|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999571|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999272|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999273|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999274|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999275|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999276|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999277|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999278|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999279|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999280|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999281|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999282|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999283|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999284|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999285|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999286|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999287|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999288|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999289|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999290|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999291|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999292|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999336|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
999293|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999294|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999295|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999296|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999297|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999298|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999299|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999300|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999301|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999302|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999303|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999304|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999305|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999306|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999307|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999308|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999309|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999310|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999311|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999312|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999313|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999572|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999314|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999315|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999316|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
999317|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999318|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999319|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999320|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999321|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999322|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999323|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999324|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999325|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999326|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
999327|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999328|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999329|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999330|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999331|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999332|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999333|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999334|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999335|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999511|NCT00815776|P3|Participant Flow|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
999337|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999338|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999339|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999340|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999341|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999342|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999343|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999344|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999345|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999346|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
999347|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999348|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999349|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999350|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999351|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999352|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999353|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999354|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999355|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999356|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
999357|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999358|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999512|NCT00815776|P2|Participant Flow|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
999359|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999360|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999361|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999362|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999363|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999364|NCT00816400|O10|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999365|NCT00816400|O9|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999366|NCT00816400|O8|Outcome|MEDI-575, 0.5 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg
999367|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999368|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999369|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999370|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999371|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999372|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999373|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999374|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999375|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999376|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999377|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999378|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999379|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999401|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999380|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999381|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999382|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999383|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999384|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999385|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999386|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999387|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999388|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999389|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999390|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999391|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999392|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999393|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999394|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999395|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999396|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999397|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999398|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999399|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999400|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999469|NCT00816036|P1|Participant Flow|Pre-intervention Period|Pre-intervention Period
999402|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999403|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999404|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999405|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999406|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999407|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999408|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999409|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999410|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999411|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999412|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999413|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999414|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999415|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999416|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999417|NCT00816400|O9|Outcome|MEDI-575, 25 mg/kg Q3Wk Expansion Phase|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999418|NCT00816400|O8|Outcome|MEDI-575, 9.0 mg/kg QWk Expansion Phase|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999419|NCT00816400|O7|Outcome|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999420|NCT00816400|O6|Outcome|MEDI-575, 25 mg/kg Q3Wk Escalation Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (once every 21 days [Q3Wk]) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999421|NCT00816400|O5|Outcome|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999422|NCT00816400|O4|Outcome|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999510|NCT00815776|B1|Baseline|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
1019364|NCT00771264|O2|Outcome|Sham / Placebo|
999423|NCT00816400|O3|Outcome|MEDI-575, 9.0 mg/kg QWk Escalation Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999424|NCT00816400|O2|Outcome|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999425|NCT00816400|O1|Outcome|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999426|NCT00816400|E7|Reported Event|MEDI-575, 35 mg/kg Q3Wk Escalation Phase (Cohort 7)|MEDI-575 administered at 35.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999427|NCT00816400|E6|Reported Event|MEDI-575, 25 mg/kg Q3Wk Escalation/Expansion Phase (Cohort 6)|MEDI-575 administered at 25.0 mg/kg as a 90-minute IV infusion on Study Day 1 of each 21-day treatment cycle (Q3Wk) until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999428|NCT00816400|E5|Reported Event|MEDI-575, 15 mg/kg QWk Escalation Phase (Cohort 5)|MEDI-575 administered at 15.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999429|NCT00816400|E4|Reported Event|MEDI-575, 12 mg/kg QWk Escalation Phase (Cohort 4)|MEDI-575 administered at 12.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999430|NCT00816400|E3|Reported Event|MEDI-575, 9.0 mg/kg QWk Escalation/Expansion Phase (Cohort 3)|MEDI-575 administered at 9.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21 day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999431|NCT00816400|E2|Reported Event|MEDI-575, 6.0 mg/kg QWk Escalation Phase (Cohort 2)|MEDI-575 administered at 6.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (QWk) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999432|NCT00816400|E1|Reported Event|MEDI-575, 3.0 mg/kg QWk Escalation Phase (Cohort 1)|Single lead-in dose of MEDI-575 at 0.5 mg/kg as a 60-minute intravenous (IV) infusion administered 7 days prior to first dose at 3.0 mg/kg; MEDI-575 administered at 3.0 mg/kg as a 60-minute IV infusion on Study Days 1, 8, and 15 (once every 7 days [QWk]) of each 21-day treatment cycle until unacceptable toxicity, documentation of disease progression, or other reasons for participant withdrawal occurred.
999433|NCT00816348|B1|Baseline|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
999434|NCT00816348|P1|Participant Flow|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
999435|NCT00816348|O1|Outcome|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
999436|NCT00816348|E1|Reported Event|Omegaven|"All subjects will receive Omegaven~Omegaven: Omegaven® will be initiated at a dose of 0.5 gram/kg/day and is infused over 24 hours for 1-2 days, and then advanced to 1 gram/kg/day. Omegaven® will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven® will continue until weaned from PN. Monotherapy with Omegaven® can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/kg/day, advancing to 1 gm/kg/day."
999437|NCT00816166|B3|Baseline|Total|Total of all reporting groups
999438|NCT00816166|B2|Baseline|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
999439|NCT00816166|B1|Baseline|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
999440|NCT00816166|P2|Participant Flow|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
999441|NCT00816166|P1|Participant Flow|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
999442|NCT00816166|O2|Outcome|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
999443|NCT00816166|O1|Outcome|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
999444|NCT00816166|E2|Reported Event|Medical Therapy Group|"Medical therapy alone (“Medical Therapy Group”)~Aspirin and Clopidogrel (Medical therapy): Treatment with aspirin (81-325 mg daily for the duration of the study) and Clopidogrel (75 mg daily for first 3 months)"
999445|NCT00816166|E1|Reported Event|Stent Group|"Medical therapy + PHAROS Vitesse neurovascular stent (Stent Group)~Pharos Vitesse Neurovascular Stent System (Stent implantation): Implantation of one or more balloon-expandable Pharos Vitesse stents to treat neurovascular ischemic lesions."
999446|NCT00816101|B4|Baseline|Total|Total of all reporting groups
999447|NCT00816101|B3|Baseline|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
999448|NCT00816101|B2|Baseline|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
999449|NCT00816101|B1|Baseline|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
999450|NCT00816101|P3|Participant Flow|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
999451|NCT00816101|P2|Participant Flow|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
999452|NCT00816101|P1|Participant Flow|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
999453|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
999454|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
999455|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
999456|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
999457|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
999458|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
999459|NCT00816101|O3|Outcome|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
999460|NCT00816101|O2|Outcome|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
999461|NCT00816101|O1|Outcome|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
999462|NCT00816101|E3|Reported Event|Band-Aid® Adhesive Bandage|Adhesive bandage containing absorbtive pad secured to self-adherent strip. Placed over wound caused by curettage & electrodesiccation. Dressing changes every 2-3 days, more frequently if needed.
999463|NCT00816101|E2|Reported Event|Mepilex® Border Lite|Self-adherent soft silicone foam dressing. Placed over wound following curettage and electrodesiccation. Dressing changes every 2-3 days, more frequently if needed
999464|NCT00816101|E1|Reported Event|Procellera Dressing|"Antimicrobial dressing for partial and full-thickness wounds. Produces small amount of current when in contact with conductive fluid. Used as primary contact layer for wound following curettage and electrodesiccation.~Dressing changes every 3 days, more frequently if needed"
999465|NCT00816036|B3|Baseline|Total|Total of all reporting groups
999466|NCT00816036|B2|Baseline|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
999467|NCT00816036|B1|Baseline|Arm 1|Pre-intervention Period
999468|NCT00816036|P2|Participant Flow|Intervention Period|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
999470|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
999471|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
999472|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
999473|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
999474|NCT00816036|O2|Outcome|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
999475|NCT00816036|O1|Outcome|Arm 1|Pre-intervention Period
999476|NCT00816036|E2|Reported Event|Arm 2|"Intervention Period~Smoking Cessation Guideline Implementation: 1. Tutorial on brief cessation counseling for nurses and physicians; 2. use of an algorithm that includes recommended tobacco counseling items; 3. fax referral of motivated smokers to Quitline Iowa for proactive telephone counseling plus free nicotine replacement therapy; 4. group and individual feedback for staff"
999477|NCT00816036|E1|Reported Event|Arm 1|Pre-intervention Period
999478|NCT00816023|B5|Baseline|Total|Total of all reporting groups
999479|NCT00816023|B4|Baseline|Placebo|
999480|NCT00816023|B3|Baseline|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
999481|NCT00816023|B2|Baseline|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
999482|NCT00816023|B1|Baseline|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
999483|NCT00816023|P4|Participant Flow|Placebo|
999484|NCT00816023|P3|Participant Flow|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
999485|NCT00816023|P2|Participant Flow|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
999486|NCT00816023|P1|Participant Flow|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
999487|NCT00816023|O4|Outcome|Placebo|
999488|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
999489|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
999490|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
999491|NCT00816023|O4|Outcome|Placebo|
999492|NCT00816023|O3|Outcome|Ecallantide High Dose|target steady state concentration of 2.25 mg/L
999493|NCT00816023|O2|Outcome|Ecallantide Medium Dose|target steady state concentration of 0.75 mg/L
999494|NCT00816023|O1|Outcome|Ecallantide Low Dose|target steady state concentration of 0.15 mg/L
999495|NCT00816023|E4|Reported Event|PLACEBO|
999496|NCT00816023|E3|Reported Event|ECALLANTIDE LOW DOSE|Target steady state concentration of 0.15 mg/L
999497|NCT00816023|E2|Reported Event|ECALLANTIDE MEDIUM DOSE|Target steady state concentration of 0.75 mg/L
999498|NCT00816023|E1|Reported Event|ECALLANTIDE HIGH DOSE|Target steady state concentration of 2.25 mg/L
999499|NCT00815919|B1|Baseline|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999500|NCT00815919|P1|Participant Flow|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999501|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999502|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999503|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999504|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999505|NCT00815919|O1|Outcome|Velcade (Bortezomib)|"Prednisone : Taken orally once a day at a dose of 0.5-1 mg/kg. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~Bortezomib : Given intravenously at a dose of 1.3 mg/m^2 once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999506|NCT00815919|E1|Reported Event|Velcade (Bortezomib)|"Prednisone : Taken orally once a day. Dose reduction may be initiated after 1 cycle of therapy. A suggested taper is 10-25% every 1-2 weeks.~bortezomib : Given intravenously once a week for the first four weeks of a five week cycle for a total of 3 cycles"
999507|NCT00815776|B4|Baseline|Total|Total of all reporting groups
999508|NCT00815776|B3|Baseline|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
999509|NCT00815776|B2|Baseline|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
1019365|NCT00771264|O1|Outcome|Urgent PC|
999513|NCT00815776|P1|Participant Flow|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
999514|NCT00815776|O3|Outcome|Jaw Exercise Group|This subject group received no device but was assigned to complete a study-specified jaw exercise program
999515|NCT00815776|O2|Outcome|Mouth Splint Group|This group was not part of the analysis
999516|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|This group of subjects received the Clayton Intra-aural Device
999517|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
999518|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
999519|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
999520|NCT00815776|O3|Outcome|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
999521|NCT00815776|O2|Outcome|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
999522|NCT00815776|O1|Outcome|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
999523|NCT00815776|E3|Reported Event|Jaw Exercise Group|Jaw exercise group, who receive no device but completed a study-specified jaw exercise program
999524|NCT00815776|E2|Reported Event|Mouth Splint Group|Group receiving an intra-oral flat-plane splint
999525|NCT00815776|E1|Reported Event|Clayton Intra-aural Device (CID) Group|Treatment group receiving the Clayton Intra-aural Device (CID)
999526|NCT00815698|B3|Baseline|Total|Total of all reporting groups
999527|NCT00815698|B2|Baseline|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
999528|NCT00815698|B1|Baseline|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
999529|NCT00815698|P2|Participant Flow|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
999530|NCT00815698|P1|Participant Flow|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
999531|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
999532|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
999533|NCT00815698|O2|Outcome|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
999534|NCT00815698|O1|Outcome|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
999535|NCT00815698|E2|Reported Event|Suture|"Suture for mesh fixation~suture: suture for mesh fixation"
999536|NCT00815698|E1|Reported Event|no Suture|"self-adhesive mesh, i.e. no suture for mesh fixation~no suture: no suture for mesh fixation, because we use a self-adhesive mesh"
999537|NCT00815685|B1|Baseline|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
999538|NCT00815685|P1|Participant Flow|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
999539|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
999540|NCT00815685|O1|Outcome|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
999541|NCT00815685|E1|Reported Event|Eicosapentaenoic Acid (Lovaza)|Participants to receive Lovaza at a dose of 4 g for 6 weeks.
999542|NCT00815659|B1|Baseline|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999543|NCT00815659|P1|Participant Flow|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999544|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999545|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999546|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999547|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999548|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999549|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999550|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999551|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999552|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999553|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999554|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999555|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999556|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999557|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999558|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999559|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999560|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999561|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999562|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999563|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999564|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999565|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999566|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999567|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999568|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999573|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999574|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999575|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999576|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999577|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999578|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999579|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999580|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999581|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999582|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999583|NCT00815659|O1|Outcome|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999584|NCT00815659|E1|Reported Event|Crestor|Rosuvastatin 10 mg/day for 6 weeks, then 20 mg/day for 6 more weeks
999585|NCT00815516|B3|Baseline|Total|Total of all reporting groups
999586|NCT00815516|B2|Baseline|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999587|NCT00815516|B1|Baseline|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999588|NCT00815516|P2|Participant Flow|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999589|NCT00815516|P1|Participant Flow|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999590|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999591|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999592|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999593|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999594|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999595|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999596|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999597|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999598|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999599|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999600|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999601|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999602|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999603|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999604|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999651|NCT00815347|E2|Reported Event|Placebo|Placebo orally, twice a day for four weeks.
999605|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999606|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999607|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999608|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999609|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999610|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999611|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999612|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999613|NCT00815516|O2|Outcome|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999614|NCT00815516|O1|Outcome|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999615|NCT00815516|E2|Reported Event|Amphotericin B|Infants received amphotericin B deoxycholate (CAB) at a dose of 1.0 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999616|NCT00815516|E1|Reported Event|Micafungin|Infants received micafungin at a dose of 10 mg/kg per day by intravenous infusion for a minimum of 21 days to a maximum of 28 days for infants without end-organ dissemination or for a maximum of 42 days for infants with end-organ dissemination.
999617|NCT00815490|B3|Baseline|Total|Total of all reporting groups
999618|NCT00815490|B2|Baseline|Validation|Group of subjects in whom the final algorithm is tested.
999619|NCT00815490|B1|Baseline|Calibration|Initial group of subjects on whom the test algorithm is developed.
999620|NCT00815490|P2|Participant Flow|Validation|Group of subjects in whom the final algorithm is tested.
999621|NCT00815490|P1|Participant Flow|Calibration|Initial group of subjects on whom the test algorithm is developed.
999622|NCT00815490|O2|Outcome|Validation|Group of subjects in whom the final algorithm is tested.
999623|NCT00815490|O1|Outcome|Calibration|Initial group of subjects on whom the test algorithm is developed.
999624|NCT00815490|E2|Reported Event|Validation|Group of subjects in whom the final algorithm is tested.
999625|NCT00815490|E1|Reported Event|Calibration|Initial group of subjects on whom the test algorithm is developed.
999626|NCT00815360|B3|Baseline|Total|Total of all reporting groups
999627|NCT00815360|B2|Baseline|Comparative Group 1|Intravitreal triamcinolone with macular laser
999628|NCT00815360|B1|Baseline|Treatment Group 1|ranibizumab and scatter laser
999629|NCT00815360|P2|Participant Flow|Comparative Group 1|Intravitreal triamcinolone with macular laser
999630|NCT00815360|P1|Participant Flow|Treatment Group 1|ranibizumab and scatter laser
999631|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
999632|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
999633|NCT00815360|O2|Outcome|Comparative Group 1|Intravitreal triamcinolone with macular laser
999634|NCT00815360|O1|Outcome|Treatment Group 1|ranibizumab and scatter laser
999635|NCT00815360|E2|Reported Event|Comparative Group 1|Intravitreal triamcinolone acetonide and macular laser
999636|NCT00815360|E1|Reported Event|Treatment Group 1|Intravitreal ranibizumab and peripheral laser
999637|NCT00815347|B1|Baseline|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
999638|NCT00815347|P1|Participant Flow|All Study Participants|Bosentan 62.5mg or placebo orally, twice a day for four weeks. After four weeks at this dose the subjects will have an increase to bosentan 125 mg or placebo orally twice daily for another four weeks. At week eight, subjects will crossover to bosentan or placebo depending upon their first randomization.
999639|NCT00815347|O2|Outcome|Bosentan|
999640|NCT00815347|O1|Outcome|Placebo|
999641|NCT00815347|O2|Outcome|Bosentan|
999642|NCT00815347|O1|Outcome|Placebo|
999643|NCT00815347|O2|Outcome|Bosentan|
999644|NCT00815347|O1|Outcome|Placebo|
999645|NCT00815347|O2|Outcome|Bosentan|
999646|NCT00815347|O1|Outcome|Placebo|
999647|NCT00815347|O2|Outcome|Bosentan|
999648|NCT00815347|O1|Outcome|Placebo|
999649|NCT00815347|O2|Outcome|Bosentan|
999650|NCT00815347|O1|Outcome|Placebo|
999652|NCT00815347|E1|Reported Event|Bosentan|Bosentan 62.5mg orally, twice a day for four weeks.
999653|NCT00815308|B1|Baseline|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
999654|NCT00815308|P1|Participant Flow|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
999655|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
999656|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
999657|NCT00815308|O1|Outcome|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
999658|NCT00815308|E1|Reported Event|Cetuximab, Concurrent Chemo-radiotherapy|Cetuximab, injection, loading dose400 mg/m^2,(Day1 in Week1) followed by 250 mg/m^2(Day1, every week for Weeks 2-8) Paclitaxel, injection,45 mg/m^2 (Day 1, every week for Weeks 2-8) Cisplatin, injection,20 mg/m^2 (Day 1, every week for Weeks 2-8) radiation therapy, 59.4 Gy, 1.8 Gy/33 fractions,1 fraction daily, Days 1-5 every week for Weeks 2-7, and Days 1-3 for Week 8
999659|NCT00815295|B4|Baseline|Total|Total of all reporting groups
999660|NCT00815295|B3|Baseline|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
999661|NCT00815295|B2|Baseline|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
999662|NCT00815295|B1|Baseline|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
999663|NCT00815295|P3|Participant Flow|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
999664|NCT00815295|P2|Participant Flow|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg was administered orally twice daily.
999665|NCT00815295|P1|Participant Flow|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg was administered orally twice daily.
999666|NCT00815295|O1|Outcome|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
999667|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
999668|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
999669|NCT00815295|O1|Outcome|Subjects Who Received Treatment at the MTD (Phase 1 and 2)|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at 400 mg, the MTD from Phase I.
999670|NCT00815295|O1|Outcome|Phase 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg or 400 mg was administered orally twice daily. The dose of sorafenib was escalated from 200 mg to 400 mg in successive 3+3 cohorts of patients to determine the maximum tolerated dose (MTD) of this regimen. The MTD is the maximum dose level at which 0/6 or 1/6 patients experience dose-limiting toxicity (DLT).
999671|NCT00815295|E3|Reported Event|Phase 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib was administered orally twice daily at the MTD from Phase I.
999672|NCT00815295|E2|Reported Event|Phase 1 - Dose Level 2|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 400 mg/m2 was administered orally twice daily.
999673|NCT00815295|E1|Reported Event|Phase 1 - Dose Level 1|Cetuximab was administered at the standard approved dose: 400 mg/m2 loading dose followed by 250 mg/m2 weekly. Sorafenib 200 mg/m2 was administered orally twice daily.
999674|NCT00815191|B3|Baseline|Total|Total of all reporting groups
999675|NCT00815191|B2|Baseline|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
999676|NCT00815191|B1|Baseline|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
999677|NCT00815191|P2|Participant Flow|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
999678|NCT00815191|P1|Participant Flow|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
999679|NCT00815191|O2|Outcome|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
999680|NCT00815191|O1|Outcome|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
999681|NCT00815191|E2|Reported Event|Forced Air|"Subjects assigned the forced-air warming cover will be positioned over the upper body and exposed arms before surgery begins. The forced-air warmer will be removed when surgery is completed.~a forced-air warming cover: A forced-air warming cover will be placed on the subject prior to surgery, remain on the subject during surgery and removed after surgery."
999682|NCT00815191|E1|Reported Event|Warm-water Sleeve|"The vital HEAT (vH2) Temperature Management System will be placed on the subject's arm prior to surgery,become activated after anesthesia administration and remain active until surgery ends.~vital HEAT (vH2) Temperature Management System: The vital HEAT (vH2) Temperature Management System will be placed on the subjects arm prior to surgery. remain on the arm during surgery and removed after surgery."
999683|NCT00815087|B3|Baseline|Total|Total of all reporting groups
999684|NCT00815087|B2|Baseline|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
999685|NCT00815087|B1|Baseline|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
999686|NCT00815087|P2|Participant Flow|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
999687|NCT00815087|P1|Participant Flow|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
999688|NCT00815087|O2|Outcome|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
999689|NCT00815087|O1|Outcome|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
999690|NCT00815087|E2|Reported Event|Home Rehabilitation Program (HRP)|"Exercise home program~Exercise home program : Daily exercise training"
999691|NCT00815087|E1|Reported Event|Functional Electrical Stimulation (FES)|"Functional electrical stimulation: Experimental~Functional electrical stimulation : 15 sessions of VitalStim® therapy, 60 minutes per session"
999692|NCT00815035|B3|Baseline|Total|Total of all reporting groups
999693|NCT00815035|B2|Baseline|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
999694|NCT00815035|B1|Baseline|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999695|NCT00815035|P3|Participant Flow|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999696|NCT00815035|P2|Participant Flow|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
999697|NCT00815035|P1|Participant Flow|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999698|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999699|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
999700|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999701|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999702|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
999703|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999704|NCT00815035|O3|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999705|NCT00815035|O2|Outcome|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
999976|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
999706|NCT00815035|O1|Outcome|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999707|NCT00815035|O1|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999708|NCT00815035|O1|Outcome|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999709|NCT00815035|E3|Reported Event|Open Label Phase-Peanut OIT|"Subjects receiving open-label peanut OIT treatment after unblinding through the end of study.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999710|NCT00815035|E2|Reported Event|Blinded Phase-Placebo|"Subjects randomized over the first 44+ weeks to receive placebo in the form of oat flour.~Placebo: Oat flour used as a placebo that is orally ingested a graded fashion"
999711|NCT00815035|E1|Reported Event|Blinded Phase-Peanut OIT|"Subjects randomized over the initial 44+ weeks to receive active treatment with peanut OIT.~Peanut OIT: Peanut flour that is orally ingested in a graded fashion."
999712|NCT00814983|B3|Baseline|Total|Total of all reporting groups
999713|NCT00814983|B2|Baseline|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
999714|NCT00814983|B1|Baseline|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
999715|NCT00814983|P2|Participant Flow|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
999716|NCT00814983|P1|Participant Flow|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
999717|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
999718|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
999719|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
999720|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
999721|NCT00814983|O2|Outcome|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
999722|NCT00814983|O1|Outcome|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
999723|NCT00814983|E2|Reported Event|Naive T-cell Depleted Stem Cell Transplant|Experimental: Cohort 2 will receive a T-cell depleted peripheral blood stem cell graft. All other aspects of this stem cell transplantation are in line with the standard of care.
999724|NCT00814983|E1|Reported Event|Stem Cell Transplant No Manipulation|Control: Cohort 1 Stem Cell Transplant No Manipulation will receive the currently accepted standard approach to myeloablative allogeneic stem cell transplantation
999725|NCT00814970|B1|Baseline|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999726|NCT00814970|P1|Participant Flow|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999727|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
999728|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
999729|NCT00814970|O1|Outcome|Complete Self-expanding (SE) Vascular Stent System|"Device: Complete Self-expanding (SE) Vascular Stent System >~> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999752|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999977|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
999730|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.~Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD)."
999731|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999732|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999733|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999734|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999735|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999736|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999737|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999738|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999739|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999740|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999741|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999742|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999743|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999744|NCT00814970|O1|Outcome|Complete SE Vascular Stent System|"Device: Complete SE Vascular Stent System >~> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system."
999745|NCT00814970|E1|Reported Event|1. Complete SE Vascular Stent System|Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
999746|NCT00814892|B1|Baseline|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999747|NCT00814892|P1|Participant Flow|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999748|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999749|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999750|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999751|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999973|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
999753|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999754|NCT00814892|O1|Outcome|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999755|NCT00814892|E1|Reported Event|DC-APCC|Patients undergo standard leukapheresis to harvest peripheral blood mononuclear cells for dendritic cell vaccine preparation. Patients receive the APCC vaccine and autologous dendritic cells derived from CD14-positive myeloid peripheral blood cells ID on days 0, 14, and 28 and then every 28 days for up to 14 courses in the absence of disease progression or unacceptable toxicity.
999756|NCT00814879|B3|Baseline|Total|Total of all reporting groups
999757|NCT00814879|B2|Baseline|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999758|NCT00814879|B1|Baseline|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999759|NCT00814879|P2|Participant Flow|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999760|NCT00814879|P1|Participant Flow|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999761|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999762|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999763|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999764|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999765|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999766|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999767|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999768|NCT00814879|O1|Outcome|N(t)NRTI + Plr|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999769|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999770|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999771|NCT00814879|O2|Outcome|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999772|NCT00814879|O1|Outcome|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999773|NCT00814879|E2|Reported Event|RAL + ATV|"Raltegravir (RAL) 400mg BID + atazanavir (ATV) 300 mg BID~Raltegravir: 400 mg BID~Atazanavir: 300 mg BID"
999774|NCT00814879|E1|Reported Event|N(t)RTI(s) + PI/r|"N(t)RTI(s) based backbone & PI/r~Standard treatment regimen: N(t)RTI(s) based backbone plus ritonavir boosted PI"
999775|NCT00814801|B4|Baseline|Total|Total of all reporting groups
999776|NCT00814801|B3|Baseline|Galantamine Group 2|Galantamine 24 mg/day
999777|NCT00814801|B2|Baseline|Galantamine Group 1|Galantamine 16 mg/day
999778|NCT00814801|B1|Baseline|Placebo Group|
999779|NCT00814801|P3|Participant Flow|Galantamine Group 2|Galantamine 24 mg/day
999780|NCT00814801|P2|Participant Flow|Galantamine Group 1|Galantamine 16 mg/day
999781|NCT00814801|P1|Participant Flow|Placebo Group|
999782|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
999783|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
999784|NCT00814801|O1|Outcome|Placebo Group|
999785|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
999786|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
999787|NCT00814801|O1|Outcome|Placebo Group|
999788|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
999789|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
999790|NCT00814801|O1|Outcome|Placebo Group|
999791|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
999792|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
999793|NCT00814801|O1|Outcome|Placebo Group|
999794|NCT00814801|O3|Outcome|Galantamine Group 2|Galantamine 24 mg/day
999795|NCT00814801|O2|Outcome|Galantamine Group 1|Galantamine 16 mg/day
999796|NCT00814801|O1|Outcome|Placebo Group|
999797|NCT00814801|E3|Reported Event|Galantamine Group 2|Galantamine 24 mg/day
999798|NCT00814801|E2|Reported Event|Galantamine Group 1|Galantamine 16 mg/day
999799|NCT00814801|E1|Reported Event|Placebo Group|
999800|NCT00814788|B1|Baseline|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bicalutamide: Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
999801|NCT00814788|P1|Participant Flow|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
999802|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide: 50 mg oral tablet daily~Everolimus: 10 mg oral capsule daily"
999803|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
999804|NCT00814788|O1|Outcome|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bicalutamide: Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
999805|NCT00814788|E1|Reported Event|Bicalutamide + Everolimus|"Patients receive oral bicalutamide and oral everolimus once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Bicalutamide 50 mg oral daily~Everolimus: RAD001 10 mg oral capsule daily - continuously."
999806|NCT00814775|B3|Baseline|Total|Total of all reporting groups
999807|NCT00814775|B2|Baseline|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
999808|NCT00814775|B1|Baseline|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
999809|NCT00814775|P2|Participant Flow|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
999810|NCT00814775|P1|Participant Flow|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
999811|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
999812|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
999813|NCT00814775|O2|Outcome|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
999814|NCT00814775|O1|Outcome|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
999815|NCT00814775|E2|Reported Event|CTrach|"Intubation of difficult airway using CTrach Laryngeal Mask~CTrach Laryngeal Mask: CTrach Laryngeal Mask intubation"
999816|NCT00814775|E1|Reported Event|Fastrach|"Fastrach Laryngeal Mask Airway intubation~Fastrach Laryngeal Mask: Intubation of difficult airway using Fastrach Laryngeal Mask"
999817|NCT00814710|B3|Baseline|Total|Total of all reporting groups
999818|NCT00814710|B2|Baseline|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999819|NCT00814710|B1|Baseline|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999820|NCT00814710|P2|Participant Flow|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999821|NCT00814710|P1|Participant Flow|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999822|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999823|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999824|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999825|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999826|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999827|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999828|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999829|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999830|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999831|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999832|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999833|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999974|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
999834|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999835|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999836|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999837|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999838|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999839|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999840|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999841|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999842|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999843|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999844|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999845|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999846|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999847|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999848|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999849|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999850|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999851|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999852|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999853|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999854|NCT00814710|O2|Outcome|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999855|NCT00814710|O1|Outcome|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999856|NCT00814710|E2|Reported Event|Hiberix Group and Tritanrix-HepB Group|Subjects received HiberixTM intramuscularly in the right thigh co-administered with TritanrixTM-HepB intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999857|NCT00814710|E1|Reported Event|Synflorix and Tritanrix-HepB/Hib Group|Subjects received SynflorixTM (GSK1024850A) intramuscularly in the right thigh co-administered with TritanrixTM-HepB/Hib intramuscularly in the left thigh at 6-10-14 weeks of age (=study month 0, 1, 2)
999858|NCT00814697|B1|Baseline|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
999859|NCT00814697|P1|Participant Flow|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
999860|NCT00814697|O1|Outcome|Cognitive Assessment|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
999861|NCT00814697|E1|Reported Event|rTMS|"rTMS treatment in Alzheimer's disease~Repetitive Transcranial Magnetic Coil Stimulation (rTMS) : Using rTMS to treat language deficits in Alzheimer's patients"
999862|NCT00814671|B4|Baseline|Total|Total of all reporting groups
999863|NCT00814671|B3|Baseline|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999864|NCT00814671|B2|Baseline|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999865|NCT00814671|B1|Baseline|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999866|NCT00814671|P3|Participant Flow|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999867|NCT00814671|P2|Participant Flow|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999868|NCT00814671|P1|Participant Flow|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999869|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999870|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999871|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999872|NCT00814671|O3|Outcome|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999873|NCT00814671|O2|Outcome|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999874|NCT00814671|O1|Outcome|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999875|NCT00814671|E3|Reported Event|RPT 600|"Rifapentine 600mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999876|NCT00814671|E2|Reported Event|RIF 600|"Rifampin 600mg daily~Rifampin: rifampin 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999877|NCT00814671|E1|Reported Event|RPT450|"Rifapentine 450mg daily~Rifapentine: rifapentine 450 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks~Rifapentine: rifapentine 600 mg + isoniazid + pyrazinamide + ethambutol once a day, seven days a week for 8 weeks"
999878|NCT00814658|B3|Baseline|Total|Total of all reporting groups
999879|NCT00814658|B2|Baseline|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999880|NCT00814658|B1|Baseline|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999881|NCT00814658|P2|Participant Flow|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999882|NCT00814658|P1|Participant Flow|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999883|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999884|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999885|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999886|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999887|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999888|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999889|NCT00814658|O8|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999890|NCT00814658|O7|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999891|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 16)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999892|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 16)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999893|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999894|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999895|NCT00814658|O2|Outcome|Galantamine + Placebo (Week 4)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999896|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Week 4)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999897|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999898|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999899|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999900|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999901|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999902|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999903|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999904|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999905|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999906|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999907|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999908|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999909|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999910|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999911|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999912|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999975|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
999913|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999914|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999915|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999916|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999917|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999918|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999919|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999920|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999921|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999922|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999923|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999924|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999925|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999926|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999927|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999928|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999929|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999930|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999931|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999932|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999933|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999934|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999935|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
1000158|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
999936|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999937|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999938|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999939|NCT00814658|O6|Outcome|Galantamine + Placebo (Week 24)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999940|NCT00814658|O5|Outcome|Galantamine + Nimodipine (Week 24)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999941|NCT00814658|O4|Outcome|Galantamine + Placebo (Week 8)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999942|NCT00814658|O3|Outcome|Galantamine + Nimodipine (Week 8)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999943|NCT00814658|O2|Outcome|Galantamine + Placebo (Baseline)|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999944|NCT00814658|O1|Outcome|Galantamine + Nimodipine (Baseline)|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999945|NCT00814658|E2|Reported Event|Galantamine + Placebo|Galantamine 8 mg/day and placebo three times a day (tid) for 4 weeks, followed by 4 weeks of galantamine 16 mg/day and placebo tid. If necessary and well tolerated, galantamine dosage may be increased to 24 mg/day, together with placebo tid.
999946|NCT00814658|E1|Reported Event|Galantamine + Nimodipine|Galantamine 8 mg/day for one month + nimodipine 30 mg 3 times a day (tid), followed by 4 weeks of galantamine 16 mg/day + nimodipine 30 mg tid. If necessary and well tolerated, dosage of galantamine will be increased to 24 mg/day + nimodipine 30 mg tid.
999947|NCT00814632|B1|Baseline|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
999948|NCT00814632|P1|Participant Flow|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
999949|NCT00814632|O1|Outcome|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
999950|NCT00814632|E1|Reported Event|Study Drug CC 10004|Study drug CC-10004 20mg taken orally twice a day for 12 weeks.
999951|NCT00814580|B3|Baseline|Total|Total of all reporting groups
999952|NCT00814580|B2|Baseline|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
999953|NCT00814580|B1|Baseline|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
999954|NCT00814580|P2|Participant Flow|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
999955|NCT00814580|P1|Participant Flow|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
999956|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
999957|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
999958|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
999959|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
999960|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
999961|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
999962|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
999963|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
999964|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
999965|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
999966|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
999967|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
999968|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
999969|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
999970|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
999971|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
999972|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
999978|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
999979|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
999980|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
999981|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
999982|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
999983|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
999984|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
999985|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
999986|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
999987|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
999988|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
999989|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
999990|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
999991|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
999992|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
999993|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
999994|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
999995|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
999996|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
999997|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
999998|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
999999|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
1000000|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
1000001|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
1000002|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
1000003|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
1000004|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
1000005|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
1000006|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
1000007|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
1000008|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
1000009|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
1000010|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
1000011|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
1000012|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
1000013|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
1000014|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
1000015|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
1000016|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
1000017|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
1000018|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
1000019|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
1000020|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
1000021|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
1000022|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
1000023|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
1000024|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
1000259|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000025|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
1000026|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
1000027|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
1000028|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Oxycodone IR Participants who missed the measurement at the end of study.
1000029|NCT00814580|O5|Outcome|Baseline - Total|Total Oxycodone IR participants at the baseline.
1000030|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
1000031|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
1000032|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
1000033|NCT00814580|O1|Outcome|End of Study: Not at All|Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
1000034|NCT00814580|O6|Outcome|End of Study: Missing the Measurement|Tapentadol IR Participants who missed the measurement at the end of study.
1000035|NCT00814580|O5|Outcome|Baseline - Total|Total Tapentadol IR participants at the baseline.
1000036|NCT00814580|O4|Outcome|End of Study: 6-7 Days|Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
1000037|NCT00814580|O3|Outcome|End of Study: 3-5 Days|Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
1000038|NCT00814580|O2|Outcome|End of Study: 1-2 Days|Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
1000039|NCT00814580|O1|Outcome|End of Study: Not at All|Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
1000040|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000041|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000042|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000043|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000044|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000045|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000046|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000047|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000048|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000049|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000050|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000051|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000052|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000053|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000054|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000055|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000056|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000057|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000058|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000059|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000060|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000061|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000062|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000063|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000064|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000065|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000066|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000067|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000068|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000069|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000070|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000071|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000072|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000073|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000074|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000075|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000076|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000077|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000078|NCT00814580|O2|Outcome|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000079|NCT00814580|O1|Outcome|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000080|NCT00814580|E2|Reported Event|Oxycodone IR|Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
1000081|NCT00814580|E1|Reported Event|Tapentadol IR|Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
1000082|NCT00814502|B3|Baseline|Total|Total of all reporting groups
1000083|NCT00814502|B2|Baseline|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000084|NCT00814502|B1|Baseline|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000085|NCT00814502|P2|Participant Flow|Placebo|"Subjects randomized to Placebo~After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Placebo received Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000086|NCT00814502|P1|Participant Flow|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects randomized to Zolpidem CR received Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000087|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000088|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000089|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000090|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000091|NCT00814502|O2|Outcome|Placebo|"Subjects randomized to Placebo~After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000092|NCT00814502|O1|Outcome|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects took Zolpidem CR 6.25mg by mouth (1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000093|NCT00814502|E2|Reported Event|Placebo|"Subjects randomized to Placebo~Zolpidem CR placebo: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000094|NCT00814502|E1|Reported Event|Zolpidem CR|"Subjects randomized to Zolpidem CR~Zolpidem CR: After a 48-hour period of baseline actigraphy and clinical measurements, study subjects will be randomized to take either Zolpidem CR 6.25mg by mouth (1 pink tablet) or Placebo by mouth (also 1 pink tablet) for up to 3 weeks or the end of the subjects' hospital stay."
1000095|NCT00814489|B4|Baseline|Total|Total of all reporting groups
1000096|NCT00814489|B3|Baseline|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000097|NCT00814489|B2|Baseline|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted GSK2254232A Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000098|NCT00814489|B1|Baseline|GSK2254233A Group|Subjects received 2 doses of GSK2254233A adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2.The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000099|NCT00814489|P3|Participant Flow|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000100|NCT00814489|P2|Participant Flow|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000101|NCT00814489|P1|Participant Flow|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000102|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000103|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000104|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000105|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000106|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000107|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000108|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000109|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000110|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000111|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000112|NCT00814489|O2|Outcome|GSK2254232A Non-adjuvanted Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000113|NCT00814489|O1|Outcome|GSK2254232A Adjuvanted Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000114|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000115|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000116|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000117|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000118|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000119|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000120|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000121|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000122|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000123|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000124|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000125|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000126|NCT00814489|O3|Outcome|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000127|NCT00814489|O2|Outcome|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000128|NCT00814489|O1|Outcome|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000129|NCT00814489|E3|Reported Event|Engerix Group|Subjects received 3 doses of Engerix vaccine at Months 0, 2 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000159|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000130|NCT00814489|E2|Reported Event|GSK2254232A Group|Subjects received 2 doses of non-adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254232A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000131|NCT00814489|E1|Reported Event|GSK2254233A Group|Subjects received 2 doses of adjuvanted Non-Typable Haemophilus influenza and pneumococcal vaccine GSK2254233A at Months 0 and 2. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
1000132|NCT00814463|B1|Baseline|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
1000133|NCT00814463|P1|Participant Flow|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
1000134|NCT00814463|O1|Outcome|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
1000135|NCT00814463|E1|Reported Event|Post-operative SRS|"All patients will undergo SRS with the planned target volume (PTV) defined as the resection cavity plus a 3-mm margin after surgical resection of a single brain metastasis. Dose will be prescribed to the maximum isodose line completely encompassing the PTV using the guidelines established in RTOG 9005. All patients will be evaluated for neurocognitive function via Mini-Mental State Examination (MMSE), Quality of Life (QOL) via FACT-Br, and for local recurrence via MRI every 3 months over the course of the study.~QOL via FACT-Br : Quality of Life via FACT-BR every 3 months for length of study.~Post-operative SRS : Single fraction SRS is currently a viable treatment option of intracranial metastatic lesions.~MMSE : Neurocognitive function via MMSE done every 3 months for length of study.~MRI : MRI done every 3 months for the length of the study."
1000136|NCT00814346|B3|Baseline|Total|Total of all reporting groups
1000137|NCT00814346|B2|Baseline|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
1000138|NCT00814346|B1|Baseline|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
1000139|NCT00814346|P2|Participant Flow|Placebo|Placebo 1 tablet twice a day for 4 weeks CNE, MC, and AD patients
1000140|NCT00814346|P1|Participant Flow|EGb761 120 mg|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients and 17 months (Open phase) for CNE and MC patients
1000141|NCT00814346|O2|Outcome|EGb761 120 mg (MC)|EGb761 120 mg 17 months (open phase) for MC patients
1000142|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000143|NCT00814346|O3|Outcome|EGb761 120 mg (Open Phase)|EGb761 120 mg twice a day for 17 months (open phase) for MC and CNE patients
1000144|NCT00814346|O2|Outcome|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
1000145|NCT00814346|O1|Outcome|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg twice a day for 4 weeks (double-blind phase) for CNE, MC and AD patients
1000146|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000147|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000148|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000149|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000150|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000151|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000152|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000153|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000154|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000155|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000156|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000157|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000258|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000160|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000161|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000162|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000163|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000164|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (Open phase) for MC patients
1000165|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000166|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000167|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000168|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000169|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000170|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000171|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000172|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000173|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000174|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000175|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000176|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000177|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000178|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000179|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000180|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000181|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000182|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000183|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000184|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000185|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000186|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000187|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000188|NCT00814346|O4|Outcome|Placebo (MC)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
1000189|NCT00814346|O3|Outcome|EGb761 120 mg (MC)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
1000190|NCT00814346|O2|Outcome|Placebo (CNE)|Placebo 1 tablet twice a day for 4 weeks for CNE, MC and AD patients
1000191|NCT00814346|O1|Outcome|EGb761 120 mg (CNE)|EGb761 120 mg tablet twice a day for 4 weeks (Double-blind phase) for CNE, MC, and AD patients
1000192|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000193|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000194|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patients
1000195|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000196|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC patient
1000197|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000198|NCT00814346|O2|Outcome|EGb 120 mg (Open Phase - MC)|EGb761 120 mg 17 months (open phase) for MC patients
1000199|NCT00814346|O1|Outcome|EGb 120 mg (Open Phase - CNE)|EGb761 120 mg tablet twice a day for 17 months (open phase) for CNE patients
1000200|NCT00814346|E3|Reported Event|EGb761 120 mg (Open Phase)|EGb761 120 mg tablet twice a day for 17 months (open phase) for MC and CNE patients
1000201|NCT00814346|E2|Reported Event|Placebo (Double-blind Phase)|Placebo 1 tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
1000202|NCT00814346|E1|Reported Event|EGb761 120 mg (Double-blind Phase)|EGb761 120 mg tablet twice a day for 4 weeks (double-blind phase) for CNE, MC, and AD patients
1000203|NCT00814333|B3|Baseline|Total|Total of all reporting groups
1000204|NCT00814333|B2|Baseline|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
1000205|NCT00814333|B1|Baseline|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
1000206|NCT00814333|P2|Participant Flow|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
1000207|NCT00814333|P1|Participant Flow|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
1000208|NCT00814333|O2|Outcome|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
1000209|NCT00814333|O1|Outcome|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
1000210|NCT00814333|E2|Reported Event|Thrombin-JMI|Thrombin-JMI: 5,000 IU, to nasal mucosa via syringe spray applicator
1000211|NCT00814333|E1|Reported Event|Merocel Pack|"Standard of care for persons being treated for epistaxis.~Merocel pack: 8 cm pack, inserted within the affected side between the septum and inferior turbinate via bayonet forceps"
1000212|NCT00814320|B3|Baseline|Total|Total of all reporting groups
1000213|NCT00814320|B2|Baseline|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of Subcutaneous (SC) infusions Recombinant human hyaluronidase (rHuPH20) + immune globulin intravenous (IGIV).~Participants who previously participated in Study 160601 entered this study at Epoch 2. PK data collected during IV treatment in Study 160601 were used for comparison with PK data from SC treatment during this study (160603).~EPOCH 2: (ramp-up and After ramp-up). Participants were treated SC with GAMMAGARD LIQUID/KIOVIG at 108% of IV dose from Epoch 1 or Study 160601. 108% was derived from PK data from Study 160602. Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.~Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment (ramp-up), to allow participants to adjust to increasing volume administered SC. Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
1000214|NCT00814320|B1|Baseline|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
1000215|NCT00814320|P2|Participant Flow|12 Years and Older|"EPOCH 1: Pharmacokinetics (PK) of intravenous (IV) administration of immune globulin intravenous (IGIV), 10%.~Participants who previously participated in Study 160601 entered this study directly to Epoch 2 ramp-up. PK data collected during IV treatment in Study 160601 was compared with PK data from subcutaneous (SC) treatment during this study.~EPOCH 2 RAMP-UP (ramp-up):Treatment intervals/ doses used for initial SC infusions of IGIV, 10% were slowly increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC. Prior to SC infusions, recombinant human hyaluronidase (rHuPH20) was administered at a minimum dose of 75 U/g IgG.~EPOCH 2 after RAMP-UP: Participants were treated SC with IGIV, 10% with rHuPH20 at 108% of IV dose from Epoch 1 (or from study 160601). Prior to SC infusions, rHuPH20 was administered at a minimum dose of 75 U/g IgG.~Aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
1000216|NCT00814320|P1|Participant Flow|2 to <12 Years|"The same as the other study arm/group (please see 12 Years and Older, due to character limitation) with the exception of the pharmacokinetic assessment that was done. For participants aged 2 to <12 years, immunoglobulin G (IgG) trough levels only were assessed in order to avoid multiple blood drawings in small children."
1000217|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
1000218|NCT00814320|O1|Outcome|Participants in Safety Data Analysis Set|Participants exposed to either or both study drugs
1000219|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000220|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000221|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000222|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000223|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000224|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000225|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 With Ramp-up|
1000226|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000227|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000228|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000229|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000230|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000231|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000232|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000233|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000234|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000235|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000236|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000237|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000238|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000239|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000240|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000241|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000242|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000243|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000244|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000245|NCT00814320|O2|Outcome|Study Epoch 2|Epoch 2 - SC administration of IGIV, 10% with rHuPH20 after ramp-up
1000246|NCT00814320|O1|Outcome|Study Epoch 1|Epoch 1 - IV administration of IGIV, 10%
1000247|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000248|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000249|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|
1000250|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000251|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000252|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000253|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000254|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000255|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000256|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000257|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000261|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000262|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000263|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000264|NCT00814320|O1|Outcome|SC Administration of IGIV, 10% With rHuPH20 at Ramp-up|At start of SC administration of IGIV, 10% with rHuPH20, the first SC dose was a 1-week dose given for a 1-week interval, then if the 1 week SC infusions were tolerated, each week the interval (and dose) was increased by 1 week, until the treatment interval was the same as the interval for intravenous treatment (3 weeks or 4 weeks)
1000265|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000266|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000267|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 Including Ramp-up|Includes 2 participants who withdrew during ramp-up SC and rHuPH20 administration of IGIV, 10%
1000268|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000269|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000270|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000271|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000272|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000273|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000274|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000275|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000276|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000277|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000278|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000279|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000280|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000281|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000282|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000283|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000284|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000285|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20 After Ramp-up|
1000286|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000287|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000288|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000289|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000290|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000291|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000292|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000293|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000294|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000295|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000296|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000297|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000298|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000299|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000300|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000301|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000302|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000303|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000304|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000305|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000306|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000307|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000308|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000309|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000310|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000311|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000312|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000313|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000314|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000315|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000316|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000317|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000318|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000319|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000320|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000321|NCT00814320|O2|Outcome|SC Administration of IGIV, 10% With rHuPH20|
1000322|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000323|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
1000324|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
1000325|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
1000326|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
1000327|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
1000328|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
1000329|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
1000330|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
1000331|NCT00814320|O2|Outcome|Participants ≥ 12 Years|
1000332|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
1000333|NCT00814320|O2|Outcome|Participants ≥12 Years|
1000334|NCT00814320|O1|Outcome|Participants Aged 2 to <12 Years|
1000335|NCT00814320|O2|Outcome|SC Administration of IGIV, 10%, With rHuPH20 After Ramp-up|
1000336|NCT00814320|O1|Outcome|IV Administration of IGIV, 10%|
1000337|NCT00814320|O1|Outcome|Ratio IgG AUC of SC With and Without rHuPH20|Percentage Ratio of IgG AUC (dose per kg) with and without rHuPH20 for SC administration of IGIV, 10%
1000338|NCT00814320|O1|Outcome|%Ratio IgG Trough Level of SC/IV|Percentage Ratio IgGTrough Level after SC administration with rHuPH20/IgG versus after IV administration of IGIV, 10% for participants aged 2 to < 12 years
1000339|NCT00814320|O1|Outcome|% Ratio IgG AUC/Week of SC/ IV|Percentage Ratio of IgG AUC (/Week) after SC administration with rHuPH20/ IgG AUC (/Week) after IV administration of IGIV, 10%
1000340|NCT00814320|O1|Outcome|Full Analysis Data Set (FADS)|All participants who had been exposed to either or both study drugs and who provided data for the primary endpoint for any period of time.
1000341|NCT00814320|E2|Reported Event|SC Administration of IGIV, 10%, With rHuPH20 (With Ramp-up)|"Consists of participants treated SC with IGIV, 10% at 108% of IV dose during administration of IGIV, 10%. This arm INCLUDES participants during ramp-up.~Ramp-up: Participants were treated with SC infusions of IGIV, 10% with recombinant human hyaluronidase (rHuPH20). Treatment intervals and doses used for initial infusions were gradually increased during first weeks of treatment to allow participants to adjust to increasing volume administered SC.~During SC administration of IGIV, 10% with rHuPh20, aim was to treat participants SC at same intervals (ie, every 3 or 4 weeks) as treated IV."
1000342|NCT00814320|E1|Reported Event|IV Administration of IGIV, 10%|Consists of Pharmacokinetics (PK) of Intravenous (IV) treatment and efficacy and tolerability of IV infusions of immune globulin intravenous (IGIV), 10%.
1000343|NCT00814307|B5|Baseline|Total|Total of all reporting groups
1000344|NCT00814307|B4|Baseline|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000345|NCT00814307|B3|Baseline|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000346|NCT00814307|B2|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000347|NCT00814307|B1|Baseline|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000348|NCT00814307|P4|Participant Flow|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000349|NCT00814307|P3|Participant Flow|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000350|NCT00814307|P2|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000351|NCT00814307|P1|Participant Flow|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000352|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000353|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000354|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000355|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000356|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000357|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000358|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000359|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000360|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000361|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000362|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000363|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000364|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000365|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000366|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000367|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000368|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000369|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000370|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000371|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000372|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000373|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000374|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000375|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000376|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000377|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000378|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000379|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000380|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000381|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000382|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000383|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000384|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000385|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000386|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000387|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000388|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000389|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000390|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000391|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000392|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000393|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000394|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000395|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000396|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000397|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000398|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000399|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000400|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000401|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000402|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000403|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000404|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000405|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000406|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000407|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000408|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000409|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000410|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000411|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000412|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000413|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000414|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000415|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000416|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000417|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000418|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000419|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000420|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000421|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000422|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000423|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000424|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000425|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000426|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000427|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000428|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000429|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000430|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000431|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000432|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000433|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000434|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000435|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000436|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000437|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000438|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000439|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000440|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000441|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000442|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000443|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000444|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000445|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000446|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000447|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000448|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000449|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000450|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000451|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000452|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000453|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000454|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000455|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000456|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000457|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000458|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000459|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000460|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000461|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000462|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000463|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000464|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000465|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000466|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000467|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000468|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000469|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000470|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000471|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000472|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000473|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000474|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000475|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000476|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000477|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000478|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000479|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000480|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000481|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000482|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000483|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000484|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000485|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000486|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000487|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000488|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000489|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000490|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000491|NCT00814307|O4|Outcome|Placebo, Then CP-690,550 10 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 10 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000492|NCT00814307|O3|Outcome|Placebo, Then CP-690,550 5 mg|Matching placebo tablet orally twice daily up to Month 3 followed by CP-690,550 5 mg tablet twice daily from Month 3 up to Month 6 or early termination.
1000493|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000494|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000495|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000496|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000497|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000498|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000499|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000500|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000501|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000502|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000503|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000504|NCT00814307|O3|Outcome|Placebo|Matching placebo tablet orally twice daily up to Month 3.
1000505|NCT00814307|O2|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Month 6.
1000506|NCT00814307|O1|Outcome|CP-690,550 5 mg|CP-690,550 5 milligram (mg) tablet orally twice daily up to Month 6.
1000507|NCT00814307|E5|Reported Event|CP-690550 10 mg (Post Month 3)|CP-690550 10 mg tablet orally twice daily from Month 3 to Month 6.
1000508|NCT00814307|E4|Reported Event|CP-690550 5 mg (Post Month 3)|CP-690550 5 mg tablet orally twice daily from Month 3 to Month 6.
1000509|NCT00814307|E3|Reported Event|Placebo (Up To Month 3)|Matching placebo tablet orally twice daily up to Month 3.
1000510|NCT00814307|E2|Reported Event|CP-690550 10 mg (Up To Month 3)|CP-690550 10 mg tablet orally twice daily up to Month 3.
1000511|NCT00814307|E1|Reported Event|CP-690550 5 mg (Up To Month 3)|CP-690550 5 mg tablet orally twice daily up to Month 3.
1000512|NCT00814255|B4|Baseline|Total|Total of all reporting groups
1000513|NCT00814255|B3|Baseline|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
1000514|NCT00814255|B2|Baseline|Conservative Medical Therapy|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
1000515|NCT00814255|B1|Baseline|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
1000516|NCT00814255|P3|Participant Flow|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
1000517|NCT00814255|P2|Participant Flow|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
1000518|NCT00814255|P1|Participant Flow|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
1000519|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
1000520|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
1000521|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
1000522|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
1001003|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
1000523|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
1000524|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
1000525|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
1000526|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
1000527|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
1000528|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID~NOTE: This study arm was originally to receive rosiglitazone. One participant was assigned to this study arm prior to the therapy being changed to galactose."
1000529|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
1000530|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
1000531|NCT00814255|O3|Outcome|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID 2 out of 7"
1000532|NCT00814255|O2|Outcome|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day 2 out of 7"
1000533|NCT00814255|O1|Outcome|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days 0 out of 7"
1000534|NCT00814255|E3|Reported Event|Conservative Medical Therapy Plus Galactose|"drug: galactose 0.2 g /kg/dose (maximum dose 15g) po BID~galactose: galactose 0.2 g/kg/dose (maximum dose 15 g)po BID"
1000535|NCT00814255|E2|Reported Event|Conservative Medical Therapy (Lisinopril, Losartan, Atorvastat|"Conservative medical therapy (lisinopril, losartan, atorvastatin)~Lisinopril, losartan, and atorvastatin: Lisinopril PO 10-20 mg per day Losartan PO 25-50 mg per day Atorvastatin PO 10-20 mg per day"
1000536|NCT00814255|E1|Reported Event|Conservative Medical Therapy Plus Adalimumab|"Conservative medical therapy plus adalimumab~Adalimumab: Adalimumab 24 mg/m2 (maximum dose 40 mg) sc q 14 days"
1000537|NCT00814177|B3|Baseline|Total|Total of all reporting groups
1000538|NCT00814177|B2|Baseline|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
1000539|NCT00814177|B1|Baseline|No Change|Intervention Drug warfarin no change in the dose is performed
1000540|NCT00814177|P2|Participant Flow|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
1000541|NCT00814177|P1|Participant Flow|No Change|Intervention Drug warfarin no change in the dose is performed
1000542|NCT00814177|O2|Outcome|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
1000543|NCT00814177|O1|Outcome|No Change|Intervention Drug warfarin no change in the dose is performed
1000544|NCT00814177|E2|Reported Event|Change|Intervention Drug Warfarin One dose increased if subtherapeutic level; one dose deleted or reduced if supratherapeutic level
1000545|NCT00814177|E1|Reported Event|No Change|Intervention Drug warfarin no change in the dose is performed
1000546|NCT00814164|B1|Baseline|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000547|NCT00814164|P1|Participant Flow|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000548|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000549|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000550|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000551|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1001004|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1000552|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000553|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000554|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000555|NCT00814164|O1|Outcome|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000556|NCT00814164|E1|Reported Event|Clorafarbine With Daunorubicin|"Patients receive clofarabine IV over 1 hour on days 1-5 and daunorubicin hydrochloride IV over 5 minutes on days 1, 3, and 5.~clofarabine: IV~daunorubicin hydrochloride: IV~cytogenetic analysis: Correlative study~protein expression analysis: Correlative Study~immunologic technique: Correlative Study~pharmacological study: Correlative Study"
1000557|NCT00814138|B3|Baseline|Total|Total of all reporting groups
1000558|NCT00814138|B2|Baseline|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000559|NCT00814138|B1|Baseline|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000560|NCT00814138|P2|Participant Flow|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000561|NCT00814138|P1|Participant Flow|1 - Methotrexate (2.5 mg)|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000562|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000563|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000564|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000565|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000566|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000567|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000568|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000569|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000570|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000571|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000572|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
1000573|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg/day for 2 weeks and then increase to 15mg/day for 2 weeks and then 20mg/day until the end of the study
1000574|NCT00814138|O2|Outcome|Placebo|Placebo: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000575|NCT00814138|O1|Outcome|Methotrexate|Methotrexate: 10 mg weekly for 2 weeks and then increase to 15mg for 2 weeks and then 20mg weekly until the end of the study
1000576|NCT00814138|E2|Reported Event|Placebo Group - Adverse Events|Reported the number of adverse events in the group randomized to placebo
1000577|NCT00814138|E1|Reported Event|Methotrexate Group - Adverse Events|Reported the number of adverse events in the group randomized to methotrexate.
1000578|NCT00813995|B3|Baseline|Total|Total of all reporting groups
1000579|NCT00813995|B2|Baseline|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
1000580|NCT00813995|B1|Baseline|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
1000581|NCT00813995|P2|Participant Flow|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
1000582|NCT00813995|P1|Participant Flow|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
1000583|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
1000584|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
1000585|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
1000586|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
1000587|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
1000588|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1700 mg/day) for 24 weeks.
1000589|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
1001005|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000590|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy (1000 mg/day) for 24 weeks.
1000591|NCT00813995|O2|Outcome|Placebo|Placebo tablets q.d. and a stable dose of metformin therapy for 24 weeks.
1000592|NCT00813995|O1|Outcome|Sitagliptin|Sitagliptin phosphate 100 mg tablets once daily (q.d.) and a stable dose of metformin therapy for 24 weeks.
1000593|NCT00813995|E2|Reported Event|Placebo|
1000594|NCT00813995|E1|Reported Event|Sitagliptin|
1000595|NCT00813982|B1|Baseline|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
1000596|NCT00813982|P1|Participant Flow|Experimental Contact Lens / Commercial Contact Lens|Lotrafilcon A experimental contact lens randomly assigned to one eye, with Lotrafilcon A commercial contact lens assigned to the fellow eye for contralateral wear.
1000597|NCT00813982|O2|Outcome|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
1000598|NCT00813982|O1|Outcome|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens worn for one week on the same basis as habitual lenses -- ie., either on a daily wear or extended wear modality.
1000599|NCT00813982|E2|Reported Event|Lotrafilcon A Experimental Contact Lens|Experimental spherical silicone hydrogel contact lens
1000600|NCT00813982|E1|Reported Event|Lotrafilcon A Commercial Contact Lens|Commercial spherical silicone hydrogel contact lens
1000601|NCT00813943|B4|Baseline|Total|Total of all reporting groups
1000602|NCT00813943|B3|Baseline|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000603|NCT00813943|B2|Baseline|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000604|NCT00813943|B1|Baseline|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000605|NCT00813943|P3|Participant Flow|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000606|NCT00813943|P2|Participant Flow|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000607|NCT00813943|P1|Participant Flow|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000608|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000609|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000660|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000610|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000611|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000612|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000613|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000614|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000615|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000616|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000617|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000618|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000619|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000620|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000621|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000622|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000623|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000624|NCT00813943|O1|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000625|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000626|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000627|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000628|NCT00813943|O3|Outcome|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000629|NCT00813943|O2|Outcome|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000630|NCT00813943|O1|Outcome|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000631|NCT00813943|E3|Reported Event|Temozolomide + Radiotherapy|TMZ 75 mg/m^2 administered intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason.
1000686|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1019366|NCT00771264|E2|Reported Event|Sham / Placebo|
1000632|NCT00813943|E2|Reported Event|Cilengitide (5-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 mg 5-times weekly over 1 hour intravenous infusion from Weeks -1 to 77, TMZ 75 mg/m^2 intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and RTX at a dose of 2 Gy per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000633|NCT00813943|E1|Reported Event|Cilengitide (2-times Weekly) + Temozolomide + Radiotherapy|Cilengitide 2000 milligram (mg) twice weekly over 1 hour intravenous infusion from Weeks -1 to 77, Temozolomide (TMZ) 75 milligram per square meter [mg/m^2] intravenously once daily from Weeks 1 to 6, from Week 11 onward, TMZ was given as maintenance treatment at a dose of 150-200 mg/m^2 for consecutive 5 days every 4 weeks until Week 34 and radiotherapy (RTX) at a dose of 2 Gray (Gy) per fraction once daily, 5 days per week from Weeks 1 to 6 or until occurrence of progressive disease, unacceptable toxicity, or withdrawal for any other reason. Continuation of cilengitide treatment after Week 77 was optional in participants without disease progression, If considered beneficial in the opinion of the Investigator.
1000634|NCT00813917|B3|Baseline|Total|Total of all reporting groups
1000635|NCT00813917|B2|Baseline|Placebo|nonactive lookalike pill per day for 12 weeks
1000636|NCT00813917|B1|Baseline|Varenicline|varenicline-1mg/day for 12 weeks
1000637|NCT00813917|P2|Participant Flow|Placebo|nonactive lookalike pill per day for 12 weeks
1000638|NCT00813917|P1|Participant Flow|Varenicline|varenicline-1mg/day for 12 weeks
1000639|NCT00813917|O2|Outcome|Placebo|nonactive lookalike pill per day for 12 weeks
1000640|NCT00813917|O1|Outcome|Varenicline|varenicline-1mg/day for 12 weeks
1000641|NCT00813917|E2|Reported Event|Placebo|nonactive lookalike pill per day for 12 weeks
1000642|NCT00813917|E1|Reported Event|Varenicline|varenicline-1mg/day for 12 weeks
1000643|NCT00813904|B1|Baseline|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
1000644|NCT00813904|P1|Participant Flow|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
1000645|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
1000646|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
1000647|NCT00813904|O1|Outcome|rThrombin, 1000 IU/mL|At least 1 application of reconstituted rThrombin, 1000 IU/mL, applied topically directly to the bleeding site.
1000648|NCT00813904|E1|Reported Event|TOTAL|
1000649|NCT00813813|B3|Baseline|Total|Total of all reporting groups
1000650|NCT00813813|B2|Baseline|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000651|NCT00813813|B1|Baseline|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000652|NCT00813813|P2|Participant Flow|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000653|NCT00813813|P1|Participant Flow|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000654|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000655|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000656|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000657|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000658|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000659|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000661|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000662|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000663|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000664|NCT00813813|O2|Outcome|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000665|NCT00813813|O1|Outcome|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000666|NCT00813813|E2|Reported Event|Intradiscal rhGDF-5 (1.0mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000667|NCT00813813|E1|Reported Event|Intradiscal rhGDF-5 (0.25mg)|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc.
1000668|NCT00813800|B1|Baseline|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
1000669|NCT00813800|P1|Participant Flow|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
1000670|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
1000671|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
1000672|NCT00813800|O1|Outcome|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
1000673|NCT00813800|E1|Reported Event|Varenicline|Open-label; subjects will receive a behavioral intervention in addition to Varenicline. Varenicline (Chantix®, Pfizer) is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4-7, and then to the maintenance dose of 1 mg twice daily for the 12 weeks of treatment.
1000674|NCT00813761|B3|Baseline|Total|Total of all reporting groups
1000675|NCT00813761|B2|Baseline|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000676|NCT00813761|B1|Baseline|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000677|NCT00813761|P4|Participant Flow|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
1000678|NCT00813761|P3|Participant Flow|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
1000679|NCT00813761|P2|Participant Flow|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
1000680|NCT00813761|P1|Participant Flow|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
1000681|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000682|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000683|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000684|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000685|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1019367|NCT00771264|E1|Reported Event|Urgent PC|
1000687|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000688|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000689|NCT00813761|O4|Outcome|ReNU MPS (Non-Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000690|NCT00813761|O3|Outcome|ReNU MPS (Stainers)|ReNU users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000691|NCT00813761|O2|Outcome|Clear Care LCS (Non-Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000692|NCT00813761|O1|Outcome|Clear Care LCS (Stainers)|Clear Care LCS users: Any subject that presented with diffuse punctate staining in three or more peripheral sectors in each eye was classified as a 'stainer' during slit-lamp examination, those who did not were termed 'non-stainers'.
1000693|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000694|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000695|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000696|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000697|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000698|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000699|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000700|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000701|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000702|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000703|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000704|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000705|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000706|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000707|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000708|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000709|NCT00813761|O2|Outcome|ReNU MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose Solution
1000710|NCT00813761|O1|Outcome|Clear Care LCS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
1000711|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000712|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000713|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000714|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000715|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000716|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000717|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000718|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000719|NCT00813761|O2|Outcome|ReNU MPS|Subjects assigned to ReNU multi purpose solution
1000720|NCT00813761|O1|Outcome|Clear Care LCS|Subjects assigned to Clear Care lens care solution
1000721|NCT00813761|O2|Outcome|ReNU Multi Purpose Solution (MPS)|All subjects assigned to ReNU MPS
1000722|NCT00813761|O1|Outcome|Clear Care Lens Cleaning Solution (LCS)|All subjects assigned to Clear Care LCS
1000723|NCT00813761|E4|Reported Event|Proclear CL and Clear Care LCS|Proclear contact lens and Clear Care lens care solution
1000724|NCT00813761|E3|Reported Event|02Optix CL and Clear Care LCS|O2Optix contact lens and Clear Care lens care solution
1000725|NCT00813761|E2|Reported Event|Proclear CL and ReNu MPS|Proclear contact lens and ReNu MultiPlus Multi-Purpose
1000726|NCT00813761|E1|Reported Event|02Optix CL and ReNu MPS|O2Optix contact lens and ReNu MultiPlus Multi-Purpose Solution
1000727|NCT00813748|B3|Baseline|Total|Total of all reporting groups
1000728|NCT00813748|B2|Baseline|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
1000729|NCT00813748|B1|Baseline|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000730|NCT00813748|P2|Participant Flow|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
1000731|NCT00813748|P1|Participant Flow|Omalizumab Cases|Participants who received omalizumab (Xolair) and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1001006|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
1001007|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1000732|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
1000733|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000734|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
1000735|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000736|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
1000737|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000738|NCT00813748|O2|Outcome|Omalizumab Controls|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions subsequent to omalizumab dosing and were from the same site or region for their matched anaphylaxis case participant.
1000739|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000740|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000741|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000742|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000743|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000744|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000745|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000746|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000747|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000748|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000749|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000750|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000751|NCT00813748|O1|Outcome|Omalizumab Cases|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000752|NCT00813748|E4|Reported Event|Skin Test Substudy: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
1000753|NCT00813748|E3|Reported Event|Skin Test Substudy: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000754|NCT00813748|E2|Reported Event|Observational Study: Omalizumab Controls – Without Anaphylaxis|Participants who received omalizumab within 18 months (either before or after) of the matched case participant’s anaphylaxis occurrence (index date) and had not experienced anaphylaxis and/or severe hypersensitivity reactions and were from the same site or region for their matched anaphylaxis case participant.
1000755|NCT00813748|E1|Reported Event|Observational Study: Omalizumab Cases – With Anaphylaxis|Participants who received omalizumab and had anaphylaxis and/or severe hypersensitivity reactions which were adjudicated by an independent clinical expert to determine that they qualified as anaphylaxis or anaphylactoid reactions on the basis of the Sampson Criteria.
1000756|NCT00813709|B4|Baseline|Total|Total of all reporting groups
1000757|NCT00813709|B3|Baseline|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (18 participants from DB converted to CDMS and switched to OL period over course of this study)
1000758|NCT00813709|B2|Baseline|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (26 participants from DB converted to CDMS and switched to OL period over course of this study)
1000759|NCT00813709|B1|Baseline|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (9 participants from DB converted to CDMS and switched to OL period over course of this study)
1000760|NCT00813709|P6|Participant Flow|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
1000761|NCT00813709|P5|Participant Flow|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
1000762|NCT00813709|P4|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
1000763|NCT00813709|P3|Participant Flow|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1000764|NCT00813709|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1000765|NCT00813709|P1|Participant Flow|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1000766|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1000767|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1001008|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000768|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1000769|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1000770|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1000771|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1000772|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000773|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000774|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000775|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000776|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000777|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000778|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000865|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000779|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000780|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000781|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000782|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000783|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000784|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000785|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000786|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000787|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000788|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000866|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1000789|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000790|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
1000791|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
1000792|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
1000793|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 99 participants were initially assigned to DB RNF 44 mcg thrice weekly and 28 participants were initially assigned to OL RNF 44 mcg thrice weekly (6 participants from DB converted to CDMS and switched to OL period over course of this study)
1000794|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 117 participants were initially assigned to DB RNF 44 mcg thrice weekly and 25 participants were initially assigned to OL RNF 44 mcg thrice weekly (10 participants from DB converted to CDMS and switched to OL period over course of this study)
1000795|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of RNF injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. 84 participants were initially assigned to DB RNF 44 mcg thrice weekly and 49 participants were initially assigned to OL RNF 44 mcg thrice weekly (4 participants from DB converted to CDMS and switched to OL period over course of this study)
1000796|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000867|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1001009|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
1000797|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000798|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000799|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000800|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000801|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months.
1000802|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
1000803|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
1000804|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1000805|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
1000806|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first.
1000807|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1000808|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000868|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1001010|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1001011|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000809|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000810|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000811|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000812|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000813|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000814|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000815|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000816|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000817|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000818|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1001012|NCT00813098|E3|Reported Event|Placebo|Matching placebo dosing with daily oral intake
1019368|NCT00771238|B3|Baseline|Total|Total of all reporting groups
1000819|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000820|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000821|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000822|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000823|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000824|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000825|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000826|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000827|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000848|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000828|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000829|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000830|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000831|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000832|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000833|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000834|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000835|NCT00813709|O3|Outcome|RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000836|NCT00813709|O2|Outcome|RNF 44 Mcg Once Weekly (Integrated ITT Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 36 months or until conversion to CDMS whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000849|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000837|NCT00813709|O1|Outcome|Placebo/RNF 44 Mcg Thrice Weekly (Integrated ITT Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first. After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months.
1000838|NCT00813709|E6|Reported Event|RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
1000839|NCT00813709|E5|Reported Event|RNF 44 Mcg Once Weekly /OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
1000840|NCT00813709|E4|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly/OL RNF 44 Mcg Thrice Weekly|Participants after having converted to CDMS during study 28981 (REFLEXION), received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months. The participants who were converted to CDMS in study 27025 (REFLEX) and were enrolled in this study continued receiving RNF 44 mcg three times weekly until 60 months.
1000841|NCT00813709|E3|Reported Event|RNF 44 Mcg Thrice Weekly (DB Population)|Single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1000842|NCT00813709|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and then 44 mcg until 60 months or until conversion to CDMS whichever occurs first.
1000843|NCT00813709|E1|Reported Event|Placebo/RNF 44 Mcg Thrice Weekly (DB Population)|Participants who were initially randomized in study 27025 (REFLEX) to the placebo treatment group were switched to single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of Interferon [IFN]-beta-1a (RNF) injection administered subcutaneously 3 times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 60 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
1000844|NCT00813592|B1|Baseline|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000845|NCT00813592|P1|Participant Flow|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000846|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000847|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1001013|NCT00813098|E2|Reported Event|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1001014|NCT00813098|E1|Reported Event|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000850|NCT00813592|O1|Outcome|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000851|NCT00813592|O1|Outcome|All Participants|SOM230B : SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000852|NCT00813592|E1|Reported Event|All Participants|SOM230B: SOM230 is an injectable somatostatin analogue. Like natural somatostatin and other somatostatin analogues (SRIFa), SOM230 exerts its pharmacological activity via binding to somatostatin receptors (sst). There are five known somatostatin receptors: sst 1, 2, 3, 4 and 5. Somatostatin receptors are expressed in different tissues under normal physiological conditions. Somatostatin analogues activate these receptors with different potencies (Schmid and Schoeffter 2004) and this activation results in a reduced cellular activity and inhibition of hormone secretion. Somatostatin receptors are strongly expressed in many solid tumors, especially in neuroendocrine tumors where hormones are excessively secreted e.g. acromegaly (Freda 2002), GEP/NET tumors (Oberg, et al 2004) and Cushing's disease.
1000853|NCT00813488|B1|Baseline|Total Number of Patients|
1000854|NCT00813488|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Subjects in this treatment group were assigned 15 mg oxycodone during the first titration period and then 200 mcg FBT during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
1000855|NCT00813488|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Subjects in this treatment group were assigned 200 mcg FBT during the first titration period and then 15 mg oxycodone during the second titration period. Standard rescue medication could be taken if pain relief was unsuccessful. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased (in 200 mcg increments for FBT and 15 mg increments for oxycodone). The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
1000856|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1000857|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000858|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1000859|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000860|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1000861|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000862|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1000863|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000864|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1001015|NCT00812981|B3|Baseline|Total|Total of all reporting groups
1001016|NCT00812981|B2|Baseline|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1000869|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000870|NCT00813488|O2|Outcome|Standard of Care (SOC)|Randomized open-label extension to either FBT or alternate short-acting oral opioid therapy.
1000871|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000872|NCT00813488|O1|Outcome|Total|"Includes all patients who participated in the double-blind treatment period and completed treatment.~Immediate-release oxycodone or matching placebo at doses of 15, 30, 45, and 60 mg was self-administered by patients.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000873|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000874|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000875|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000876|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000877|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000878|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000879|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000880|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000881|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1001076|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1000882|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000883|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000884|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000885|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000886|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000887|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000888|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000889|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000890|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000891|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000892|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000904|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000893|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000894|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000895|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000896|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000897|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000898|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000899|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000900|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000901|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000902|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000903|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1001017|NCT00812981|B1|Baseline|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001077|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1000905|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000906|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000907|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000908|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000909|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000910|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000911|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000912|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000913|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000914|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000915|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1001018|NCT00812981|P2|Participant Flow|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001078|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1000916|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000917|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000918|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000919|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000920|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000921|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000922|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000923|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000924|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000925|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000926|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000938|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000927|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000928|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000929|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000930|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000931|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000932|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000933|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000934|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000935|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000936|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000937|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000995|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1000996|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000997|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
1000998|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1000939|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000940|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000941|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000942|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000943|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000944|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000945|NCT00813488|O2|Outcome|Immediate-release Oxycodone (OXY)|"Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.~Patients were initially titrated to immediate-release oxycodone during the 1st titration period and to FBT during the 2nd titration period or to FBT during the 1st titration period and immediate-release oxycodone during the 2nd titration period."
1000946|NCT00813488|O1|Outcome|Fentanyl Buccal Tablet (FBT)|"FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.~PTs were initially titrated with FBT during the 1st titration period and immediate release oxycodone during the 2nd titration period or immediate-release oxycodone in the 1st titration period then FBT in the 2nd titration period.~During the 12-week open-label extension period, pts randomized to FBT treatment were initially dispensed single tablets at the dose found to be successful during the titration period."
1000947|NCT00813488|E3|Reported Event|Standard of Care|21 subjects received standard of care analgesics apart from oxycodone or FBT during the Open-Label Extension Period. Subjects who took oxycodone during SOC are listed under Oxycodone.
1000948|NCT00813488|E2|Reported Event|Oxycodone|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period (they were only exposed to one drug). 213 subjects began the first titration period and of those 27 discontinued before exposure to oxycodone. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 186 subjects had exposure to oxycodone
1000949|NCT00813488|E1|Reported Event|Fentanyl Buccal Tablet|This was a crossover study in which subjects were first randomized to receive Fentanyl Buccal Tablet (FBT) or oxycodone in two titration periods of the study (titrated once with one drug and again with the other) and then were randomized to double-blind treatment first with one drug then the other. As a result, all subjects were exposed to both FBT and oxycodone at different times except for subjects who discontinued before the second titration period. 213 subjects began the first titration period and of those 17 discontinued before exposure to FBT. Including Titration Periods, Double-blind Treatment Periods and Open-Label Extension Periods 196 subjects had exposure to FBT
1000950|NCT00813319|B3|Baseline|Total|Total of all reporting groups
1000951|NCT00813319|B2|Baseline|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
1000999|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
1001000|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
1001001|NCT00813098|O2|Outcome|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1020193|NCT00768599|P3|Participant Flow|Control|Vehicle Foam
1000952|NCT00813319|B1|Baseline|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
1000953|NCT00813319|P2|Participant Flow|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
1000954|NCT00813319|P1|Participant Flow|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
1000955|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
1000956|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
1000957|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
1000958|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
1000959|NCT00813319|O2|Outcome|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
1000960|NCT00813319|O1|Outcome|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
1000961|NCT00813319|E2|Reported Event|2 - General Health Promotion|Adolescents will watch an equally short (10 min) DVD on healthy lifestyles and behaviors. HPV awareness and vaccination will not be addressed.
1000962|NCT00813319|E1|Reported Event|1 - Girls OnGuard/HPV Awareness|"Adolescents will watch a short (10 min), interactive DVD designed to promote HPV awareness and initial GARDASIL vaccination and receive a keepsake to help them remember to return to the clinic for their second and third vaccine doses.~Girls OnGuard: Using the Information-Motivation-Behavioral Skills Model (IMB) as a framework, Girls OnGuard is an interactive,culturally-appropriate, computer-delivered program design to enhance initial uptake of GARDASIL by addressing three major components: (1) information about GARDASIL; (2) motivation to obtain GARDASIL vaccination; and (3) behavioral skills to enhance self-efficacy of obtaining GARDASIL vaccination."
1000963|NCT00813150|B3|Baseline|Total|Total of all reporting groups
1000964|NCT00813150|B2|Baseline|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
1000965|NCT00813150|B1|Baseline|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
1000966|NCT00813150|P2|Participant Flow|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
1000967|NCT00813150|P1|Participant Flow|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
1001002|NCT00813098|O1|Outcome|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000968|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
1000969|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
1000970|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
1000971|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
1000972|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
1000973|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
1000974|NCT00813150|O2|Outcome|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
1000975|NCT00813150|O1|Outcome|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
1000976|NCT00813150|E2|Reported Event|Vcd (Bortezomib + Low-dose Dexamethasone + Cyclophosphamide)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle and single oral doses of 50 mg cyclophosphamide on a once daily basis from Day 1, Cycle 1 continuously until Day 21, Cycle 8.
1000977|NCT00813150|E1|Reported Event|Vd (Bortezomib + Dexamethasone)|Participants received bortezomib at a dose of 1.3 mg/m² body surface area (BSA) for eight 3-week cycles. Within each cycle it was administered twice weekly (on Days 1, 4, 8, and 11) followed by a 10-day rest period (Days 12 through 21). They received single oral doses of 20 mg dexamethasone on Days 1 and 2, 4 and 5, 8 and 9, and 11 and 12 of each cycle.
1000978|NCT00813111|B3|Baseline|Total|Total of all reporting groups
1000979|NCT00813111|B2|Baseline|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
1000980|NCT00813111|B1|Baseline|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
1000981|NCT00813111|P2|Participant Flow|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
1000982|NCT00813111|P1|Participant Flow|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
1000983|NCT00813111|O2|Outcome|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
1000984|NCT00813111|O1|Outcome|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
1000985|NCT00813111|E2|Reported Event|Bupivacaine HCl|A single local administration of 100 mg in a 20-mL volume into each breast implant pocket for a total dose of 200 mg (i.e., a total of 40 mL)
1000986|NCT00813111|E1|Reported Event|SKY0402|A single local administration of 300 mg in a 20-mL volume into each breast implant pocket for a total dose of 600 mg (i.e., a total of 40 mL)
1000987|NCT00813098|B4|Baseline|Total|Total of all reporting groups
1000988|NCT00813098|B3|Baseline|Placebo|Matching placebo dosing with daily oral intake
1000989|NCT00813098|B2|Baseline|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1000990|NCT00813098|B1|Baseline|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000991|NCT00813098|P3|Participant Flow|Placebo|Matching placebo dosing with daily oral intake
1000992|NCT00813098|P2|Participant Flow|Low Dose|A low dose of LX1031; daily oral intake for 28 days
1000993|NCT00813098|P1|Participant Flow|High Dose|A high dose of LX1031; daily oral intake for 28 days
1000994|NCT00813098|O3|Outcome|Placebo|Matching placebo dosing with daily oral intake
1001019|NCT00812981|P1|Participant Flow|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001020|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001021|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001022|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001023|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001024|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001025|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001026|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001027|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001028|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001029|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001030|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001031|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001032|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001033|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001034|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001035|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001036|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001037|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001038|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001039|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001040|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001041|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001042|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001043|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001133|NCT00812877|E1|Reported Event|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
1001044|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001045|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001046|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001047|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001048|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001049|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001050|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001051|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001052|NCT00812981|O2|Outcome|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001053|NCT00812981|O1|Outcome|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001054|NCT00812981|E2|Reported Event|1562902A CP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the comparative-processed (CP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001055|NCT00812981|E1|Reported Event|1562902A NP Group|Healthy male or female adults, between and including 18 to 60 years of age, who received two doses of the new-processed (NP) 1562902A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm, at Days 0 and 21.
1001056|NCT00812968|B1|Baseline|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001057|NCT00812968|P1|Participant Flow|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle. Treatment continued until disease progression or relapse following an erythroid improvement was documented, any of the criteria for treatment discontinuation was violated, or lenalidomide became commercially available for the treatment of MDS associated with a del (5q) cytogenetic abnormality, for up to 156 weeks (3 years).
1001058|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001059|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001060|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001061|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001062|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001063|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001064|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001065|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001066|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001067|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001068|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1001069|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1001070|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1001071|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1001072|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1001073|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1001074|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1001075|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1001079|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1001080|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1001081|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1001082|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1001083|NCT00812968|O2|Outcome|Lenalidomide: Day 4|Analysis of PK parameters on Day 4, after participants had received 10 mg of lenalidomide administered orally once daily for 4 days.
1001084|NCT00812968|O1|Outcome|Lenalidomide: Day 1|Analysis of PK parameters on Day 1, after a single dose of 10 mg of lenalidomide administered orally.
1001085|NCT00812968|O1|Outcome|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001086|NCT00812968|E1|Reported Event|Lenalidomide|10 mg of lenalidomide was administered orally once daily on Days 1 to 21 of every 28-day cycle, for up to 156 weeks (3 years).
1001087|NCT00812955|B5|Baseline|Total|Total of all reporting groups
1001088|NCT00812955|B4|Baseline|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
1001089|NCT00812955|B3|Baseline|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
1001090|NCT00812955|B2|Baseline|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
1001091|NCT00812955|B1|Baseline|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
1001092|NCT00812955|P4|Participant Flow|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
1001093|NCT00812955|P3|Participant Flow|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
1001094|NCT00812955|P2|Participant Flow|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
1001095|NCT00812955|P1|Participant Flow|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
1001096|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
1001097|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
1001098|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
1001099|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
1001100|NCT00812955|O4|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
1001101|NCT00812955|O3|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
1001102|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
1001103|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
1001104|NCT00812955|O2|Outcome|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg
1001105|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
1001106|NCT00812955|O2|Outcome|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg
1001107|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
1001108|NCT00812955|O2|Outcome|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg
1001109|NCT00812955|O1|Outcome|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg
1001110|NCT00812955|E4|Reported Event|ABT-143 Capsules 20/135 mg|ABT-143 capsules 20/135 mg once daily for 8 weeks
1001111|NCT00812955|E3|Reported Event|ABT-143 Capsules 10/135 mg|ABT-143 capsules 10/135 mg once daily for 8 weeks
1001112|NCT00812955|E2|Reported Event|ABT-143 Capsules 5/135 mg|ABT-143 capsules 5/135 mg once daily for 8 weeks
1001113|NCT00812955|E1|Reported Event|Simvastatin Capsules 40 mg|Simvastatin capsules 40 mg once daily for 8 weeks
1001114|NCT00812916|B1|Baseline|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
1001115|NCT00812916|P1|Participant Flow|Number of Patients|Radiofrequency (RF) Ablation using specialized complex fractionated atrial electrogram (CFAE) software
1001116|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
1001117|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
1001118|NCT00812916|O1|Outcome|RF Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
1001119|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized CFAE software
1001120|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
1001121|NCT00812916|O1|Outcome|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
1001122|NCT00812916|E1|Reported Event|Radiofrequency (RF) Ablation|RF Ablation using specialized complex fractionated atrial electrogram (CFAE) software
1001123|NCT00812877|B3|Baseline|Total|Total of all reporting groups
1001124|NCT00812877|B2|Baseline|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
1001125|NCT00812877|B1|Baseline|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
1001126|NCT00812877|P2|Participant Flow|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
1001127|NCT00812877|P1|Participant Flow|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
1001128|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
1001129|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
1001130|NCT00812877|O2|Outcome|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
1001131|NCT00812877|O1|Outcome|Mineral Trioxide Aggregate|Pulp capping agent, Mineral Trioxide Aggregate used as a direct pulp cap
1001132|NCT00812877|E2|Reported Event|Calcium Hydroxide|Pulp capping agent, Calcium Hydroxide used as a direct pulp cap
1001134|NCT00812812|B3|Baseline|Total|Total of all reporting groups
1001135|NCT00812812|B2|Baseline|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001136|NCT00812812|B1|Baseline|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
1001137|NCT00812812|P2|Participant Flow|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase (total of 8 weeks). During the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase, (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001138|NCT00812812|P1|Participant Flow|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
1001139|NCT00812812|O1|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001140|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001141|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
1001142|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001143|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
1001144|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001145|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
1001146|NCT00812812|O2|Outcome|Paroxetine|Paroxetine at the initial dose of 10 milligrams (mg) was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001147|NCT00812812|O1|Outcome|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
1001148|NCT00812812|E2|Reported Event|Paroxetine|Paroxetine at the initial dose of 10 mg was orally administered once daily for the first 2 weeks of the treatment phase. In the next 6 weeks, paroxetine 10 to 20 mg for participants aged 7 to 11 years or 10 to 40 mg for participants aged 12 to 17 years was orally administered. The dose was up-titrated by one level at a time (an increment of 10 mg/day) at intervals of at least 2 weeks based on clinical judgment. During the taper phase (0 to 3 weeks), the last dose level in the treatment phase was reduced by 10 mg/day at intervals of 1 week to the final dose level of 10 mg/day.
1001149|NCT00812812|E1|Reported Event|Placebo|Participants took placebo once daily in the treatment phase (8 weeks) and the taper phase (0 to 3 weeks).
1001150|NCT00812604|B3|Baseline|Total|Total of all reporting groups
1001151|NCT00812604|B2|Baseline|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
1001152|NCT00812604|B1|Baseline|Ping On Ointment Group|Ping On Ointment was used
1001153|NCT00812604|P2|Participant Flow|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
1001154|NCT00812604|P1|Participant Flow|Ping On Ointment Group|Ping On Ointment was used
1001155|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
1001156|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
1001157|NCT00812604|O2|Outcome|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
1001158|NCT00812604|O1|Outcome|Ping On Ointment Group|Ping On Ointment was used
1001159|NCT00812604|E2|Reported Event|Placebo Group|Vaseline with minor trace of Ping On Ointment was used
1001160|NCT00812604|E1|Reported Event|Ping On Ointment Group|Ping On Ointment was used
1001161|NCT00812565|B9|Baseline|Total|Total of all reporting groups
1001162|NCT00812565|B8|Baseline|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001163|NCT00812565|B7|Baseline|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001164|NCT00812565|B6|Baseline|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001165|NCT00812565|B5|Baseline|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001166|NCT00812565|B4|Baseline|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001167|NCT00812565|B3|Baseline|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001168|NCT00812565|B2|Baseline|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001169|NCT00812565|B1|Baseline|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001170|NCT00812565|P8|Participant Flow|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001171|NCT00812565|P7|Participant Flow|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001172|NCT00812565|P6|Participant Flow|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001173|NCT00812565|P5|Participant Flow|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001174|NCT00812565|P4|Participant Flow|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001175|NCT00812565|P3|Participant Flow|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001176|NCT00812565|P2|Participant Flow|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001177|NCT00812565|P1|Participant Flow|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001178|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001179|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001180|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001181|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001182|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001183|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001184|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001185|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001186|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001187|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001188|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001189|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001190|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001191|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001192|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001193|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001194|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001195|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001196|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001197|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001198|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001199|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001200|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001201|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001202|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001203|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001204|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1020194|NCT00768599|P2|Participant Flow|Test Drug|Econazole Nitrate Foam 1%
1001205|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001206|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001207|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001208|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001209|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001210|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001211|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001212|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001213|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001214|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001215|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001216|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001217|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001218|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001219|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001220|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001221|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001222|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001223|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001224|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001225|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001226|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001227|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001228|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001229|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001230|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001231|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001232|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001233|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001234|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001235|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001236|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001237|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001238|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001239|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001240|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001241|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001242|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001243|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001244|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001245|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001246|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001247|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001248|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001249|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001250|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001251|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001252|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001253|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001254|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001255|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001256|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001257|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001258|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001259|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001260|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001261|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001262|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001263|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001264|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001265|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001266|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001267|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001268|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001269|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001270|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001271|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001272|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001273|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001274|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001275|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001276|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001277|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001278|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001279|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001280|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001281|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001282|NCT00812565|O8|Outcome|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001283|NCT00812565|O7|Outcome|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001284|NCT00812565|O6|Outcome|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001285|NCT00812565|O5|Outcome|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001286|NCT00812565|O4|Outcome|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001287|NCT00812565|O3|Outcome|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001288|NCT00812565|O2|Outcome|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001289|NCT00812565|O1|Outcome|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001290|NCT00812565|E8|Reported Event|0.8 g/kg Octagam 10% Every 4 Weeks|Participants received of 0.8 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001291|NCT00812565|E7|Reported Event|0.5 g/kg Octagam 10% Every 4 Weeks|Participants received 0.5 g/kg octagam 10% every 4 weeks for 20 weeks (total of 6 infusions).
1001292|NCT00812565|E6|Reported Event|0.2 g/kg Octagam 10% Every 4 Weeks|Participants received 0.2 g/kg octagam 10% intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001293|NCT00812565|E5|Reported Event|Placebo Every 4 Weeks|Participants received placebo intravenously every 4 weeks for 20 weeks (total of 6 infusions).
1001294|NCT00812565|E4|Reported Event|0.4 g/kg Octagam 10% Every 2 Weeks|Participants received of 0.4 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001295|NCT00812565|E3|Reported Event|0.25 g/kg Octagam 10% Every 2 Weeks|Participants received 0.25 g/kg octagam 10% every 2 weeks for 24 weeks (total of 12 infusions).
1001296|NCT00812565|E2|Reported Event|0.1 g/kg Octagam 10% Every 2 Weeks|Participants received 0.1 g/kg octagam 10% intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001297|NCT00812565|E1|Reported Event|Placebo Every 2 Weeks|Participants received placebo intravenously every 2 weeks for 24 weeks (total of 12 infusions).
1001298|NCT00812487|B3|Baseline|Total|Total of all reporting groups
1001299|NCT00812487|B2|Baseline|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001300|NCT00812487|B1|Baseline|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001301|NCT00812487|P2|Participant Flow|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001302|NCT00812487|P1|Participant Flow|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001303|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001304|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001305|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001306|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001307|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001308|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001309|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001310|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001311|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001312|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001313|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001314|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001315|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001316|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001317|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001318|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001319|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001320|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001321|NCT00812487|O2|Outcome|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001322|NCT00812487|O1|Outcome|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001323|NCT00812487|E2|Reported Event|Subcutaneous Insulin|Patients received basal and bolus insulin, approximately 5 injections of insulin/day
1001324|NCT00812487|E1|Reported Event|Intravenous Insulin|Patients received intravenous insulin according to the hospital nursing run algorithm with a target glucose of 100-150 mg/dl.
1001325|NCT00812461|B3|Baseline|Total|Total of all reporting groups
1001326|NCT00812461|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001327|NCT00812461|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
1001328|NCT00812461|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001329|NCT00812461|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
1001330|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001331|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001332|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001333|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001334|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001335|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001336|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001337|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001338|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001339|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001340|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001341|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001342|NCT00812461|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001343|NCT00812461|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001344|NCT00812461|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001345|NCT00812461|E1|Reported Event|Placebo|as-needed use, tablets, orally, 6 months
1001346|NCT00812331|B6|Baseline|Total|Total of all reporting groups
1001347|NCT00812331|B5|Baseline|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001348|NCT00812331|B4|Baseline|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001349|NCT00812331|B3|Baseline|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001350|NCT00812331|B2|Baseline|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001351|NCT00812331|B1|Baseline|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001352|NCT00812331|P5|Participant Flow|Genotype 6|Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001353|NCT00812331|P4|Participant Flow|Genotype 5|Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001354|NCT00812331|P3|Participant Flow|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001355|NCT00812331|P2|Participant Flow|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001356|NCT00812331|P1|Participant Flow|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001357|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001358|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001359|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001360|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001361|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001362|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001363|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001364|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001365|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001366|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001367|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001368|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001369|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001370|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001371|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001372|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001373|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001374|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001375|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001376|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001377|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001378|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001379|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001380|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001381|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1020826|NCT00766415|B3|Baseline|Total|Total of all reporting groups
1001382|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001383|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001384|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001385|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001386|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001387|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001388|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001389|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001390|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001391|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001392|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001393|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001394|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001395|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001396|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001397|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001398|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001399|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001400|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001401|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001402|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001403|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001404|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001405|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001406|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001407|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001408|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001409|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001410|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001411|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001412|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001413|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001414|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001415|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001416|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001417|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001418|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001419|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1020827|NCT00766415|B2|Baseline|Placebo|Placebo, twice daily
1001420|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001421|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001422|NCT00812331|O5|Outcome|Genotype 6|participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001423|NCT00812331|O4|Outcome|Genotype 5|participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001424|NCT00812331|O3|Outcome|Genotype 4|Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001425|NCT00812331|O2|Outcome|Genotype 3|Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001426|NCT00812331|O1|Outcome|Genotype 2|Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
1001427|NCT00812331|E1|Reported Event|Total|Participants with chronic genotype 2,3,4,5 or 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
1001428|NCT00812253|B3|Baseline|Total|Total of all reporting groups
1001429|NCT00812253|B2|Baseline|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
1001430|NCT00812253|B1|Baseline|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
1001431|NCT00812253|P2|Participant Flow|Subcutaneous Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
1001432|NCT00812253|P1|Participant Flow|Intravenous Insulin (IV)|Intravenous insulin: In patients assigned to intravenous (IV) insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
1001433|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
1001434|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
1001435|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
1001436|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
1001437|NCT00812253|O2|Outcome|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
1001585|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001438|NCT00812253|O1|Outcome|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
1001439|NCT00812253|E2|Reported Event|Subcutaneous (SQ) Insulin|Basal bolus insulin (4 injections per day) In subjects who were insulin naïve, the total daily dose of insulin was calculated as 0.4 or 0.5 unit/kg if the enrollment glucose was <11.1 mmol/l or >11.1 mmol/l respectively. In subjects who were not insulin naive, the total insulin dose was calculated as 100% or 120% of the total daily insulin dose at admission in subjects with an enrollment glucose of <11.1 mmol/l or >11.1 mmol/l respectively. Basal and prandial insulin were administered in approximately equal total daily doses with correction dosing and adjustments based upon a published algorithm. The target glucose range was 5.6-8.3 mmol/l.
1001440|NCT00812253|E1|Reported Event|Intravenous (IV) Insulin|Intravenous (IV) insulin: In patients assigned to IV insulin, SQ basal insulin was discontinued and IV insulin was started at 21:00 on the day of enrollment. Patients continued to receive subcutaneous prandial insulin. All patients receiving IV insulin were managed using our hospital’s universal nursing run guideline, which has a target glucose of 6.1-8.3 mmol/l. Patients were transitioned from the infusion after 48 hours using approximately 70% of the estimated basal insulin infusion requirement with 4 hours of overlap.
1001441|NCT00812110|B1|Baseline|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
1001442|NCT00812110|P1|Participant Flow|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
1001443|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
1001444|NCT00812110|O1|Outcome|Caregivers|Caregivers of children at risk for complications of influenza
1001445|NCT00812110|E1|Reported Event|Caregivers|Caregivers of children at high risk, per CDC definitions, of complications of influenza.
1001446|NCT00812097|B5|Baseline|Total|Total of all reporting groups
1001447|NCT00812097|B4|Baseline|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001448|NCT00812097|B3|Baseline|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001449|NCT00812097|B2|Baseline|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001450|NCT00812097|B1|Baseline|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001451|NCT00812097|P4|Participant Flow|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001452|NCT00812097|P3|Participant Flow|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001453|NCT00812097|P2|Participant Flow|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001501|NCT00811954|B1|Baseline|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001586|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001454|NCT00812097|P1|Participant Flow|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001455|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001456|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001457|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001458|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001459|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001460|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001461|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001462|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001463|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001464|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001465|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001580|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001466|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001467|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001468|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001469|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001470|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001471|NCT00812097|O4|Outcome|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001472|NCT00812097|O3|Outcome|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001473|NCT00812097|O2|Outcome|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001474|NCT00812097|O1|Outcome|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001475|NCT00812097|E4|Reported Event|Revision Reconstruction|"The Revision Reconstruction cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast reconstruction surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001476|NCT00812097|E3|Reported Event|Revision Augmentation|"The Revision Augmentation cohort will include patients receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants during a revision surgery to correct or improve the result of a primary breast augmentation surgery.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001477|NCT00812097|E2|Reported Event|Primary Reconstruction|"The Primary Reconstruction cohort will include patients with loss of breast due to mastectomy or with deformities secondary to disease, malignancy, trauma, and congenital deformity receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants .~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001581|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001478|NCT00812097|E1|Reported Event|Primary Augmentation|"The Primary Augmentation cohort will include patients who wish general breast enlargement receiving MENTOR® MemoryShape™ (formerly known as Contour Profile Gel [CPG]) Breast Implants.~Mentor Siltex® Contour Profile Gel Mammary Prosthesis: The MENTOR® MemoryShape™ Breast Implant mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface."
1001479|NCT00812006|B4|Baseline|Total|Total of all reporting groups
1001480|NCT00812006|B3|Baseline|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
1001481|NCT00812006|B2|Baseline|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
1001482|NCT00812006|B1|Baseline|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
1001483|NCT00812006|P3|Participant Flow|Placebo / Rizatriptan / Rizatriptan|First migraine treated with Placebo; second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
1001484|NCT00812006|P2|Participant Flow|Rizatriptan / Placebo / Rizatriptan|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Placebo; third migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT)
1001485|NCT00812006|P1|Participant Flow|Rizatriptan / Rizatriptan / Placebo|First migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); second migraine treated with Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); third migraine treated with Placebo
1001486|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
1001487|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
1001488|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
1001489|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
1001490|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
1001491|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
1001492|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
1001493|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
1001494|NCT00812006|O2|Outcome|Placebo|Placebo. Patients who treated one attack, that was intended to be treated with placebo, were included. One patient who treated an attack with placebo within 48 hours of the previous attack was excluded from the placebo group.
1001495|NCT00812006|O1|Outcome|Rizatriptan|Rizatriptan 10 mg. Patients who treated at least one attack, that was intended to be treated with rizatriptan 10 mg (excluding sponsor-provided rescue), were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group.
1001496|NCT00812006|E2|Reported Event|Placebo|"Placebo. Patients who treated an attack with placebo were included. Adverse events occurring within 14 days of administration of placebo, but not within 14 days of any administration of rizatriptan (including sponsor-provided rescue), were attributed to placebo group.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
1001497|NCT00812006|E1|Reported Event|Rizatriptan|"Rizatriptan 10 mg. Patients who treated at least one attack with rizatriptan 10 mg (including sponsor-provided rescue) were included. Although a patient may have treated twice with rizatriptan 10 mg, the patient was counted only once for the rizatriptan group. Adverse events occurring within 14 days of any administration of rizatriptan (including sponsor-provided rescue) were attributed to rizatriptan group, even if placebo was administered more recently.~It is possible for one patient to be counted twice (once in each treatment group).~The number of randomized patients is 108, out of which, 101 took at least one dose of rizatriptan (including sponsor-provided rescue), and 94 took placebo."
1001498|NCT00811954|B4|Baseline|Total|Total of all reporting groups
1001499|NCT00811954|B3|Baseline|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001500|NCT00811954|B2|Baseline|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001582|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001502|NCT00811954|P3|Participant Flow|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001503|NCT00811954|P2|Participant Flow|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001504|NCT00811954|P1|Participant Flow|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001505|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001506|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001507|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001508|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001509|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001510|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001511|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001512|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001513|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001514|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001515|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001516|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001517|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001518|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001519|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001520|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001521|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001522|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001523|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001524|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001525|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001526|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001527|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001528|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001529|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001530|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001531|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001532|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001533|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001534|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001535|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001536|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001537|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001538|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001539|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001540|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001541|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001542|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001543|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001544|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001545|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001546|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001583|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001584|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001547|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001548|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001549|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001550|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001551|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001552|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001553|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001554|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001555|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001556|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001557|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001558|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001559|NCT00811954|O3|Outcome|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001560|NCT00811954|O2|Outcome|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001561|NCT00811954|O1|Outcome|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001562|NCT00811954|E3|Reported Event|Arm C: DRV/RTV + FTC/TDF|"FTC/TDF, darunavir (DRV), and RTV, orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Darunavir: A protease inhibitor (PI) Ritonavir: A protease inhibitor (PI)"
1001563|NCT00811954|E2|Reported Event|Arm B: RAL + FTC/TDF|"FTC/TDF orally, once daily, and raltegravir (RAL) orally, twice daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Raltegravir: An integrase inhibitor (INI)"
1001564|NCT00811954|E1|Reported Event|Arm A: ATV/RTV + FTC/TDF|"Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF), ritonavir (RTV), and atazanavir (ATV) to be taken orally, once daily.~Emtricitabine/tenofovir disoproxil fumarate: A combination drug of two nucleoside reverse transcriptase inhibitors (NRTIs) Ritonavir: A protease inhibitor (PI) Atazanavir: A protease inhibitor (PI)"
1001565|NCT00811941|B3|Baseline|Total|Total of all reporting groups
1001566|NCT00811941|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001567|NCT00811941|B1|Baseline|Placebo|as-needed use, tablets, orally, 52 weeks
1001568|NCT00811941|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001569|NCT00811941|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 52 weeks
1001570|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001571|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001572|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001573|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001574|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001575|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001576|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001577|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001578|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001579|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001587|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001588|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001589|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001590|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001591|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001592|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001593|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001594|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001595|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001596|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001597|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001598|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001599|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001600|NCT00811941|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001601|NCT00811941|O1|Outcome|Placebo|as-needed use, tablets, orally, 52 weeks
1001602|NCT00811941|E2|Reported Event|Nalmefene 18.06 mg|as-needed use, tablets, orally, 52 weeks
1001603|NCT00811941|E1|Reported Event|Placebo|as-needed use, tablets, orally, 52 weeks
1001604|NCT00811928|B3|Baseline|Total|Total of all reporting groups
1001605|NCT00811928|B2|Baseline|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001606|NCT00811928|B1|Baseline|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001607|NCT00811928|P2|Participant Flow|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001608|NCT00811928|P1|Participant Flow|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001609|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001610|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001611|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001612|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001613|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001614|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001615|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001616|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001617|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001618|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001619|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001620|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001621|NCT00811928|O2|Outcome|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001622|NCT00811928|O1|Outcome|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001623|NCT00811928|E2|Reported Event|Fluconazole|Fluconazole 400 mg daily (QD), given as 2 capsules of 50 mg and 2 capsules of 150 mg (a total of 4 capsules) with or without food
1001624|NCT00811928|E1|Reported Event|Posaconazole|Posaconazole oral suspension (40 mg/ml), 200 mg (5mL) three times a day (TID) with meals
1001625|NCT00811850|B1|Baseline|All Patients|All patients in the study
1001626|NCT00811850|P1|Participant Flow|All Patients|This was a cross-over study with 3 treatment periods. In Treatment Period 1, patients received either Combigan® or Cosopt®. In Treatment Period 2, patients were washed out of their previous treatment. In Treatment Period 3, patients received either Combigan® or Cosopt® (treatment not received in Treatment Period 1).
1001627|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001628|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001629|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001630|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001631|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001632|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001728|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001633|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001634|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001635|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001636|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001637|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001638|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001639|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001640|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001641|NCT00811850|O2|Outcome|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001642|NCT00811850|O1|Outcome|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001643|NCT00811850|E2|Reported Event|Cosopt®|Cosopt® (fixed combination of dorzolamide hydrochloride - timolol maleate ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001644|NCT00811850|E1|Reported Event|Combigan®|Combigan® (fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution). One drop of study medication taken approximately 12 hours apart, dosed 2 times a day for a total of two weeks.
1001645|NCT00811798|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
1001646|NCT00811798|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
1001647|NCT00811798|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
1001648|NCT00811798|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine. Cervarix vaccine was administered intramuscularly in the deltoid of the non-dominant arm according to a 0, 1, 6-month schedule.
1001649|NCT00811733|B3|Baseline|Total|Total of all reporting groups
1001650|NCT00811733|B2|Baseline|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001651|NCT00811733|B1|Baseline|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001652|NCT00811733|P2|Participant Flow|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001653|NCT00811733|P1|Participant Flow|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001729|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001927|NCT00811252|P2|Participant Flow|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001654|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001655|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001656|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001657|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001658|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001659|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001660|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001661|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001662|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001663|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001664|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001665|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001666|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001667|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001668|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001669|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001670|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001671|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001672|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001673|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001674|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001675|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001676|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001677|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001678|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001679|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001680|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001681|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001682|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001683|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001684|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001685|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001686|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001687|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001688|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001689|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001690|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001691|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001692|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001693|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001694|NCT00811733|O2|Outcome|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001695|NCT00811733|O1|Outcome|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001696|NCT00811733|E2|Reported Event|300 mg Ofatumumab, Wk. 1; 2000 mg Ofatumumab, Wk. 2-5|Participants received ofatumumab IV at 300 mg at Week 1 and 2000 mg at Weeks 2 through 5 in Cycle 1 (defined as a treatment period of up to 5 weeks [Weeks 1 through 5]) and were followed up for 10 weeks (Weeks 6-16). After Week 16, during the RC, participants who had Minor Response or stable disease after Cycle 1 and had not received another WM therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response and subsequently progressed before 36 months entered Cycle 2 of treatment and received 300 mg at Week 1 and 2000 mg during Weeks 2 through 5.
1001697|NCT00811733|E1|Reported Event|300 mg Ofatumumab, Wk. 1; 1000/2000 mg Ofatumumab, Wk. 2-4/2-5|Participants received ofatumumab intravenously (IV) in Cycle 1 (defined as a treatment period of up to 4 weeks [Weeks (Wk.) 1 through 4]) (300 milligrams [mg] at Week 1 and 1000 mg at Weeks 2 through 4) and were followed up for 11 weeks (Weeks 5-16). After Week 16, during the Redosing Cycle (RC), participants who had Minor Response or stable disease after Cycle 1 and had not received another Waldenstrom's Macroglobulinemia (WM) therapy received 300 mg IV ofatumumab at Week 1 and 2000 mg IV ofatumumab at Weeks 2 through 5. Participants who achieved a response in either Cycle 1 or the RC and subsequently progressed before 36 months entered Cycle 2 of treatment and received IV ofatumumab 300 mg at Week 1 and IV ofatumumab 2000 mg during Weeks 2 through 5.
1001698|NCT00811720|B3|Baseline|Total|Total of all reporting groups
1001699|NCT00811720|B2|Baseline|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001700|NCT00811720|B1|Baseline|Placebo|as-needed use, tablets, orally, 6 months
1001701|NCT00811720|P2|Participant Flow|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001702|NCT00811720|P1|Participant Flow|Placebo|as-needed use, tablets, orally, 6 months
1001703|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001704|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001705|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001706|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001707|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001708|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001709|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001710|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001711|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001712|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001713|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001714|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001715|NCT00811720|O2|Outcome|Nalmefene 18.06 mg|as-needed use, tablets, orally, 6 months
1001716|NCT00811720|O1|Outcome|Placebo|as-needed use, tablets, orally, 6 months
1001717|NCT00811720|E2|Reported Event|Nalmefene 18.06 mg|
1001718|NCT00811720|E1|Reported Event|Placebo|
1001719|NCT00811655|B1|Baseline|Pre-OP SRS|"SRS pre-operatively with the planned target volume defined as the tumor plus a 3-mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
1001720|NCT00811655|P1|Participant Flow|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
1001721|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001722|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001723|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001724|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001725|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001726|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001727|NCT00811655|O1|Outcome|Pre-Operative SRS|Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.
1001730|NCT00811655|E1|Reported Event|Pre-Operative SRS|"Stereotactic radiosurgery (SRS) will be administered pre-operatively as a single fraction with the planned target volume defined as the gross tumor volume plus a 3mm margin.~therapeutic conventional surgery : Surgery of a single brain metastasis.~stereotactic radiosurgery : Pre-operative single fraction SRS"
1001731|NCT00811642|B1|Baseline|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001732|NCT00811642|P1|Participant Flow|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001733|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001734|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001735|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001736|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001737|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001738|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001739|NCT00811642|O1|Outcome|Posaconazole|"400 mg twice a day (BID) oral suspension for~12 weeks"
1001740|NCT00811642|E1|Reported Event|POSACONAZOLE|400mg oral suspension BID for 12 weeks
1001741|NCT00811590|B1|Baseline|All Patients|All patients enrolled/eligible.
1001742|NCT00811590|P1|Participant Flow|All Patients|All patients enrolled/eligible.
1001743|NCT00811590|O1|Outcome|All Patients|All enrolled/eligible patients.
1001744|NCT00811590|E1|Reported Event|All Patients|All enrolled/eligible patients.
1001745|NCT00811577|B3|Baseline|Total|Total of all reporting groups
1001746|NCT00811577|B2|Baseline|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
1001747|NCT00811577|B1|Baseline|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
1001748|NCT00811577|P2|Participant Flow|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
1001749|NCT00811577|P1|Participant Flow|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
1001750|NCT00811577|O3|Outcome|Alpha SMA Results for 10 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001751|NCT00811577|O2|Outcome|Alpha SMA Results for 3 mg AZX100 Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001752|NCT00811577|O1|Outcome|Alpha SMA Results for Placebo Trocar Scars|This group included assessment for α-SMA at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001753|NCT00811577|O9|Outcome|Collagen Fiber Orientation Results for 10 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001754|NCT00811577|O8|Outcome|Collagen Fiber Orientation Results for 3 mg AZX100 Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001755|NCT00811577|O7|Outcome|Collagen Fiber Orientation Results for Placebo Scars|This group included results for collagen fiber orientation at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001756|NCT00811577|O6|Outcome|Collagen Fiber Maturity Results for 10 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001757|NCT00811577|O5|Outcome|Collagen Fiber Maturity Results for 3 mg AZX100 Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001758|NCT00811577|O4|Outcome|Collagen Fiber Maturity Results for Placebo Scars|This group included results for collagen fiber maturity at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001759|NCT00811577|O3|Outcome|Collagen Fiber Density Results for 10 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001760|NCT00811577|O2|Outcome|Collagen Fiber Density Results for 3 mg AZX100 Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001761|NCT00811577|O1|Outcome|Collagen Fiber Density Results for Placebo Scars|This group included results for collagen fiber density at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001762|NCT00811577|O9|Outcome|Scar Total Volume for 10 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001763|NCT00811577|O8|Outcome|Scar Total Volume for 3 mg AZX100 Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001764|NCT00811577|O7|Outcome|Scar Total Volume for Placebo Trocar Scars|This group included scar total volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001765|NCT00811577|O6|Outcome|Scar Negative Volume for 10 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001851|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001928|NCT00811252|P1|Participant Flow|Placebo|capsules; daily; orally
1001766|NCT00811577|O5|Outcome|Scar Negative Volume for 3 mg AZX100 Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001767|NCT00811577|O4|Outcome|Scar Negative Volume for Placebo Trocar Scars|This group included scar negative volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001768|NCT00811577|O3|Outcome|Scar Positive Volume for 10 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001769|NCT00811577|O2|Outcome|Scar Positive Volume for 3 mg AZX100 Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001770|NCT00811577|O1|Outcome|Scar Positive Volume for Placebo Trocar Scars|This group included scar positive volume measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001771|NCT00811577|O12|Outcome|Scar Maximum Elevation for 10 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001772|NCT00811577|O11|Outcome|Scar Maximum Elevation for 3 mg AZX100 Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001773|NCT00811577|O10|Outcome|Scar Maximum Elevation for Placebo Trocar Scars|This group included scar maximum elevation measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001774|NCT00811577|O9|Outcome|Scar Minimum Elevation for 10 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001775|NCT00811577|O8|Outcome|Scar Minimum Elevation for 3 mg AZX100 Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001776|NCT00811577|O7|Outcome|Scar Minimum Elevation for Placebo Trocar Scars|This group included scar minimum elevation measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001777|NCT00811577|O6|Outcome|Scar Width for 10 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001778|NCT00811577|O5|Outcome|Scar Width for 3 mg AZX100 Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001779|NCT00811577|O4|Outcome|Scar Width for Placebo Trocar Scars|This group included scar width measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001780|NCT00811577|O3|Outcome|Scar Length for 10 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001781|NCT00811577|O2|Outcome|Scar Length for 3 mg AZX100 Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001782|NCT00811577|O1|Outcome|Scar Length for Placebo Trocar Scars|This group included scar length measurements at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001783|NCT00811577|O6|Outcome|Rater 2 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001784|NCT00811577|O5|Outcome|Rater 2 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001785|NCT00811577|O4|Outcome|Rater 2 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001786|NCT00811577|O3|Outcome|Rater 1 VAS Scores for 10 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001787|NCT00811577|O2|Outcome|Rater 1 VAS Scores for 3 mg AZX100 Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001788|NCT00811577|O1|Outcome|Rater 1 VAS Scores for Placebo Trocar Scars|This group included VAS scores at the 12 month time point for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001789|NCT00811577|O6|Outcome|OSAS Results for 10 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001790|NCT00811577|O5|Outcome|OSAS Results for 3 mg AZX100 Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001791|NCT00811577|O4|Outcome|OSAS Results for Placebo Trocar Scars|This group included OSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001792|NCT00811577|O3|Outcome|PSAS Results for 10 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 10 mg/cm at 9 days and 21 days following shoulder surgery.
1001852|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001793|NCT00811577|O2|Outcome|PSAS Results for 3 mg AZX100 Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive AZX100 3 mg/cm at 9 days and 21 days following shoulder surgery.
1001794|NCT00811577|O1|Outcome|PSAS Results for Placebo Trocar Scars|This group included PSAS results at 12 months for trocar scars that were randomized to receive saline placebo/cm at 9 days and 21 days following shoulder surgery.
1001795|NCT00811577|E2|Reported Event|Placebo-only Arm|Three trocar sites on each patient will receive one dose of placebo.
1001796|NCT00811577|E1|Reported Event|AZX100-Placebo Arm|Three trocar sites designated as anterior, lateral and posterior will be randomized on each patient to receive one low dose of AZX100, one high dose of AZX100, or placebo.
1001797|NCT00811564|B3|Baseline|Total|Total of all reporting groups
1001798|NCT00811564|B2|Baseline|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
1001799|NCT00811564|B1|Baseline|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
1001800|NCT00811564|P2|Participant Flow|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
1001801|NCT00811564|P1|Participant Flow|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
1001802|NCT00811564|O2|Outcome|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
1001803|NCT00811564|O1|Outcome|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
1001804|NCT00811564|E2|Reported Event|Latanoprost 0.005% Ophthalmic Solution|Latanoprost 0.005% ophthalmic solution
1001805|NCT00811564|E1|Reported Event|Fixed Combination of Brimonidine Tartrate 0.2%/Timolol Maleate|Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution
1001806|NCT00811473|B3|Baseline|Total|Total of all reporting groups
1001807|NCT00811473|B2|Baseline|Placebo|Matching placebo
1001808|NCT00811473|B1|Baseline|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001809|NCT00811473|P2|Participant Flow|Placebo|Matching placebo
1001810|NCT00811473|P1|Participant Flow|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001811|NCT00811473|O2|Outcome|Placebo|Matching placebo
1001812|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001813|NCT00811473|O2|Outcome|Placebo|Matching placebo
1001814|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001815|NCT00811473|O2|Outcome|Placebo|Matching placebo
1001816|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001817|NCT00811473|O2|Outcome|Placebo|Matching placebo
1001818|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001819|NCT00811473|O2|Outcome|Placebo|Matching placebo
1001820|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001821|NCT00811473|O2|Outcome|Placebo|Matching placebo
1001822|NCT00811473|O1|Outcome|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001823|NCT00811473|E2|Reported Event|Placebo|Matching placebo
1001824|NCT00811473|E1|Reported Event|Quetiapine XR|Quetiapine XR 150 to 300mg once a day
1001825|NCT00811434|B1|Baseline|All Participants|all aprticipants who were randomized to receive treatment
1001826|NCT00811434|P2|Participant Flow|Placebo First, Then Lactulose|Placebo therapy of 1.5ml/kg/day; washout; lactulose therapy based on weight
1001827|NCT00811434|P1|Participant Flow|Lactulose First, Then Placebo|Lactulose therapy based on weight; Washout; placebo therapy of 1.5ml/kg/day
1001828|NCT00811434|O2|Outcome|Placebo|1.5 ml/kg day po of sugar water placebo for three months
1001829|NCT00811434|O1|Outcome|Lactulose|3 months of Lactulose therapy based on pt. weight
1001830|NCT00811434|O1|Outcome|All Randomized Participants|
1001831|NCT00811434|O1|Outcome|All Randomized Participants|
1001832|NCT00811434|E2|Reported Event|Placebo|1.5 ml/kg day po of sugar water placebo for three months
1001833|NCT00811434|E1|Reported Event|Lactulose|3 months of Lactulose therapy based on pt. weight
1001834|NCT00811395|B7|Baseline|Total|Total of all reporting groups
1001835|NCT00811395|B6|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001836|NCT00811395|B5|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001837|NCT00811395|B4|Baseline|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001838|NCT00811395|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001839|NCT00811395|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001840|NCT00811395|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001841|NCT00811395|P6|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001842|NCT00811395|P5|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001843|NCT00811395|P4|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001844|NCT00811395|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001845|NCT00811395|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001846|NCT00811395|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001847|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001848|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001849|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001850|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001853|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001854|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001855|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001856|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001857|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001858|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001859|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001860|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001861|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001862|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001863|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001864|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001865|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001866|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001867|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001868|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001869|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001870|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001871|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001872|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001873|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001874|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001875|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001876|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001877|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001878|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001879|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001880|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001881|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001882|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001883|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001884|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001885|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001886|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001887|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001888|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001889|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
1001890|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
1001891|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
1001892|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001893|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001894|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001895|NCT00811395|O6|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA]
1001896|NCT00811395|O5|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA]
1001897|NCT00811395|O4|Outcome|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA]
1001898|NCT00811395|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001899|NCT00811395|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001900|NCT00811395|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001901|NCT00811395|E6|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA]
1001902|NCT00811395|E5|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA]
1001903|NCT00811395|E4|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA]
1020828|NCT00766415|B1|Baseline|AZD1981|AZD1981 1000 mg, twice daily
1001904|NCT00811395|E3|Reported Event|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β [IFN-β]
1001905|NCT00811395|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β [IFN-β]
1001906|NCT00811395|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β [IFN-β]
1001907|NCT00811382|B3|Baseline|Total|Total of all reporting groups
1001908|NCT00811382|B2|Baseline|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)."
1001909|NCT00811382|B1|Baseline|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC.~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring."
1001910|NCT00811382|P2|Participant Flow|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
1001911|NCT00811382|P1|Participant Flow|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
1001912|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
1001913|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
1001914|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
1001915|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
1001916|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
1001917|NCT00811382|O1|Outcome|1: Access to HMSC (Home Monitoring Service Center)|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
1001918|NCT00811382|O2|Outcome|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (CRT and AF therapy, without Home Monitoring): CRT and AF therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
1001919|NCT00811382|O1|Outcome|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of CRT and management of AF with a full access for the treating physician to the HMSC~Home Monitoring (CRT and AF therapy with Home Monitoring feature): CRT and AF therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
1001920|NCT00811382|E2|Reported Event|2: No Access to HMSC|"Limited access of the treating physician to the HMSC where only events regarding implant and lead status will be generated and sent to the physician.~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy, without Home Monitoring): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, without daily data transmission from the implant via Home Monitoring (except for the safety data on device integrity)"
1001921|NCT00811382|E1|Reported Event|1: Access to HMSC|"Full functionality of the Home Monitoring System for an early optimization of cardiac resynchronization therapy and management of atrial fibrillation with a full access for the treating physician to the Home Monitoring Service Center~Home Monitoring (Cardiac resynchronization therapy and atrial fibrillation therapy with Home Monitoring feature): Cardiac resynchronization therapy and atrial fibrillation therapy according to medical guidelines, where the physician receives relevant daily data from the implant via Home Monitoring"
1001922|NCT00811252|B4|Baseline|Total|Total of all reporting groups
1001923|NCT00811252|B3|Baseline|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001924|NCT00811252|B2|Baseline|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001925|NCT00811252|B1|Baseline|Placebo|capsules; daily; orally
1001926|NCT00811252|P3|Participant Flow|Duloxetine 60 mg|encapsulated tablets; daily; orally
1020829|NCT00766415|P2|Participant Flow|Placebo|Placebo, twice daily
1001929|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001930|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001931|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001932|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001933|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001934|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001935|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001936|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001937|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001938|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001939|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001940|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001941|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001942|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001943|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001944|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001945|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001946|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001947|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001948|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001949|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001950|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001951|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001952|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001953|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001954|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001955|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001956|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001957|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001958|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001959|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001960|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001961|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001962|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001963|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001964|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001965|NCT00811252|O3|Outcome|Duloxetine 60 mg|encapsulated tablets; daily; orally
1001966|NCT00811252|O2|Outcome|Vortioxetine 5 mg|encapsulated tablets; daily; orally
1001967|NCT00811252|O1|Outcome|Placebo|capsules; daily; orally
1001968|NCT00811252|E3|Reported Event|Duloxetine 60 mg|
1001969|NCT00811252|E2|Reported Event|Vortioxetine 5 mg|
1001970|NCT00811252|E1|Reported Event|Placebo|
1001971|NCT00811135|B1|Baseline|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001972|NCT00811135|P1|Participant Flow|Trastuzumab + Bevacizumab + Capecitabine|Participants received intravenous (IV) trastuzumab (8 milligrams per kilogram [mg/kg]) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 milligrams per meter square (mg/m^2) twice daily (BID) on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001973|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001974|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001975|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001976|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1002013|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001977|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001978|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001979|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001980|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001981|NCT00811135|O1|Outcome|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001982|NCT00811135|E1|Reported Event|Trastuzumab + Bevacizumab + Capecitabine|Participants received IV trastuzumab (8 mg/kg) for first cycle and then 6 mg/kg for subsequent cycles followed by bevacizumab (15 mg/kg) on Day 1 of each treatment cycles along with capecitabine administered orally to participants at a dose of 1000 mg/m^2 BID on Days 1 to 14 of each treatment cycle until disease progression, unmanageable toxicity or participant request for discontinuation. Treatment cycles were of 3 weeks.
1001983|NCT00811070|B7|Baseline|Total|Total of all reporting groups
1001984|NCT00811070|B6|Baseline|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001985|NCT00811070|B5|Baseline|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001986|NCT00811070|B4|Baseline|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001987|NCT00811070|B3|Baseline|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1001988|NCT00811070|B2|Baseline|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1001989|NCT00811070|B1|Baseline|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1001990|NCT00811070|P6|Participant Flow|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001991|NCT00811070|P5|Participant Flow|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001992|NCT00811070|P4|Participant Flow|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001993|NCT00811070|P3|Participant Flow|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002014|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001994|NCT00811070|P2|Participant Flow|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1001995|NCT00811070|P1|Participant Flow|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1001996|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001997|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001998|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1001999|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002000|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002001|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002002|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002003|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002004|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002005|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002006|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002007|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg - AP/BP (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase (AP/BP) third-line imatinib resistant/intolerant followed by dasatinib or nilotinib resistant/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002008|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002009|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002010|NCT00811070|O1|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002011|NCT00811070|O2|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002012|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1020833|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1002015|NCT00811070|O1|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002016|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002017|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002018|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002019|NCT00811070|O3|Outcome|Bosutinib Exploratory Third-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic or accelerated or blast phase third-line imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002020|NCT00811070|O2|Outcome|Bosutinib Advanced Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with accelerated or blast phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML). Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002021|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002022|NCT00811070|O1|Outcome|Bosutinib Primary Second-line 500 mg (Part 2 )|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML).Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy.
1002023|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002024|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002025|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002026|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002027|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002028|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002029|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002030|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002070|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002071|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002031|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002032|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002033|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002034|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002035|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002036|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002037|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002038|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002039|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002040|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002041|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002042|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002043|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002044|NCT00811070|O1|Outcome|All Treated Participants (Part 1 )|All participants who received single oral dose of bosutinib 400 mg, 500 mg or 600 mg on Day 1 and then bosutinib 400 mg, 500 mg or 600 mg orally once daily continuously from Day 3 up to Week 4.
1002045|NCT00811070|O3|Outcome|Bosutinib Second-line 600 mg (Part 1 )|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
1002046|NCT00811070|O2|Outcome|Bosutinib Second-line 500 mg (Part 1 )|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002047|NCT00811070|O1|Outcome|Bosutinib Second-line 400 mg (Part 1 )|Single oral dose of bosutinib 400 mg on Day 1 and then bosutinib 400 mg orally once daily was administered continuously from Day 3 in participants with chronic phase second-line imatinib resistant/refractory/intolerant chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred. Intra-subject dose escalation up to 600 mg was allowed for lack of efficacy after the safety confirmation of 600 mg cohort.
1002048|NCT00811070|E3|Reported Event|Total Population|Total participants who were second-line or third-line chronic myelogenous leukemia (CML).
1002049|NCT00811070|E2|Reported Event|Exploratory Third-line|All participants who received bosutinib 500 mg orally once daily in third-line chronic myelogenous leukemia (CML), participants were with imatinib resistant/refractory/intolerant followed by dasatinib or nilotinib resistant/refractory/intolerant.
1002050|NCT00811070|E1|Reported Event|Total Second-line|All participants who received bosutinib orally once daily in second-line chronic myelogenous leukemia (CML), who were imatinib resistant/refractory/intolerant.
1002051|NCT00811057|B4|Baseline|Total|Total of all reporting groups
1002052|NCT00811057|B3|Baseline|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
1002053|NCT00811057|B2|Baseline|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
1002054|NCT00811057|B1|Baseline|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
1002055|NCT00811057|P3|Participant Flow|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
1002056|NCT00811057|P2|Participant Flow|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
1002057|NCT00811057|P1|Participant Flow|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
1002058|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
1002059|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
1002060|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
1002061|NCT00811057|O3|Outcome|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
1002062|NCT00811057|O2|Outcome|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
1002063|NCT00811057|O1|Outcome|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
1002064|NCT00811057|E3|Reported Event|3 Indomethacin|"Participants randomized to this arm will receive the medication indomethacin per rectum and orally.~Indomethacin : Participants randomized to receive indomethacin will receive an initial 100mg per rectum X1, may repeat x1, and then 25 - 50mg orally every 6 hours over 48 hours as needed per physician discretion until uterine quiescence has been achieved."
1002065|NCT00811057|E2|Reported Event|2 Nifedipine|"Participants randomized to this group will receive the medication nifedipine orally.~Nifedipine : Participants randomized to receive nifedipine will receive an initial 30mg loading dose, then 10 - 20mg q 4 - 6 hours as needed, per physician discretion, until uterine quiescence is achieved."
1002066|NCT00811057|E1|Reported Event|1 Magnesium Sulfate|1 Magnesium Sulfate : Participants randomized to this arm will receive a loading dose of 6gms intravenously followed by a maintenance dose of 2-4gm/hr, per physician discretion, until uterine quiescence is achieved. The Magnesium Sulfate dosage is then titrated down until discontinued per physician discretion.
1002067|NCT00811018|B1|Baseline|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002068|NCT00811018|P1|Participant Flow|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002069|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002072|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002073|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002074|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002075|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002076|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002077|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002078|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002079|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002080|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002081|NCT00811018|O1|Outcome|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002082|NCT00811018|E1|Reported Event|Sitaxsentan|All participants received sitaxsentan 100 milligrams (mg) orally once daily beginning on Study Day 1 to termination from study.
1002083|NCT00810901|B3|Baseline|Total|Total of all reporting groups
1002084|NCT00810901|B2|Baseline|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
1002085|NCT00810901|B1|Baseline|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
1002086|NCT00810901|P2|Participant Flow|Alcohol Prevention|"Intervention used a digital video disk (DVD) and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
1002087|NCT00810901|P1|Participant Flow|Organ Donor|"Intervention used a digital video disk (DVD), text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
1002088|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
1002089|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
1002090|NCT00810901|O2|Outcome|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
1002091|NCT00810901|O1|Outcome|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
1002092|NCT00810901|E2|Reported Event|Organ Donor|"Intervention used a DVD, text messaging, emails, a website, US Mail, and telephone calls to educate teens about their choice to become a designated organ donor on their first driver's license application.~Organ Donor: Subjects receive information about becoming a designated organ donor -via DVD, email, text messaging, website, and US mail."
1002093|NCT00810901|E1|Reported Event|Alcohol Prevention|"Intervention used a DVD and text messages, to educate teens about the laws that prohibit underage minors purchasing and consuming alcohol~Alcohol Prevention: Use DVD, website, text messaging, email and US mail to educate teenagers about the consequences associated with purchasing and using alcohol."
1002094|NCT00810771|B4|Baseline|Total|Total of all reporting groups
1002095|NCT00810771|B3|Baseline|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
1002096|NCT00810771|B2|Baseline|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
1002097|NCT00810771|B1|Baseline|Preference-tailored (PT) Intervention|Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes.
1002188|NCT00810511|P1|Participant Flow|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
1002098|NCT00810771|P3|Participant Flow|Usual Care|Due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening.
1002099|NCT00810771|P2|Participant Flow|Standard Information (SI) Intervention|Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.
1002100|NCT00810771|P1|Participant Flow|Preference-tailored (PT) Intervention|"Standard Information: A computer based educational overview of CRC and CRC test options was presented to the subject. The subject was given a handout with a brief description of each of the screening options and which included the test that they have chosen as their preferred test. The subjects were asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider.~Preference-tailored Information: A preference elicitation exercise generated a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects were provided with a handout to take to their clinic appointment as were the Standard Information group, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
1002101|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
1002102|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
1002103|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
1002104|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
1002105|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
1002106|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
1002107|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
1002108|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
1002109|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information"
1002110|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information"
1002111|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
1002112|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
1002113|NCT00810771|O3|Outcome|Usual Care|"Usual Care - due to budget and time constraints this group is not powered as a true study arm but is being used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may have occurred during the study timeframe and impact rated of CRC screening."
1002114|NCT00810771|O2|Outcome|Standard Information (SI) Intervention|"Standard information (SI) intervention~Behavioral: Standard Information~Standard Information: A computer based educational overview of CRC and CRC test options will be presented to the subject. The subject will be given a handout with a brief description of each of the screening options and will include the test that they have chosen as their preferred test. The subjects will be asked to take this handout to their upcoming clinic appointment and to discuss the screening options with their care provider."
1002115|NCT00810771|O1|Outcome|Preference-tailored (PT) Intervention|"Preference-tailored (PT) intervention~Intervention:~Behavioral: Standard Information Behavioral: Preference-tailored Information~Preference-tailored Information: A preference elicitation exercise that will generate a list of the three top attributes for the subject and the CRC screening test most consistent with these attributes. Subjects will be provided with a handout to take to their clinic appointment as the Standard Information group does, but with the addition of a listing of their top attributes and the test most consistent with their top attributes."
1002133|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002116|NCT00810771|E3|Reported Event|Usual Care|"Usual Care - due to budget and time constraints this group was not powered as a true study arm but was used to assess the impact of our baseline physician information letter and to control for any other interventions of system-wide initiatives that may occur during the study timeframe and impact rated of CRC screening. Data was not collected on every participant in this arm."
1002117|NCT00810771|E2|Reported Event|Standard Information (SI) Intervention|Standard information (SI) intervention
1002118|NCT00810771|E1|Reported Event|Preference-tailored (PT) Intervention|Preference-tailored (PT) intervention
1002119|NCT00810719|B1|Baseline|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
1002120|NCT00810719|P1|Participant Flow|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
1002121|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
1002122|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
1002123|NCT00810719|O1|Outcome|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
1002124|NCT00810719|E1|Reported Event|Gemcitabine and Erlotinib|"The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.~Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.~gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle."
1002125|NCT00810693|B4|Baseline|Total|Total of all reporting groups
1002126|NCT00810693|B3|Baseline|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002127|NCT00810693|B2|Baseline|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002128|NCT00810693|B1|Baseline|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002129|NCT00810693|P3|Participant Flow|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002130|NCT00810693|P2|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002131|NCT00810693|P1|Participant Flow|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002132|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002171|NCT00810641|E1|Reported Event|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
1020834|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1002134|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002135|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002136|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002137|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002138|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002139|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002140|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002141|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002142|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002143|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002144|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002145|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002146|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002147|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002148|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002149|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002150|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002151|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002152|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002153|NCT00810693|O3|Outcome|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002154|NCT00810693|O2|Outcome|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002155|NCT00810693|O1|Outcome|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002156|NCT00810693|E3|Reported Event|Placebo|Participants received Placebo orally as a film-coated tablet three times daily (tid) for 12 weeks
1002157|NCT00810693|E2|Reported Event|Riociguat (Adempas, BAY63-2521) up to 1.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 1.5mg three times daily (tid) (titration between 1.0 mg and 1.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002158|NCT00810693|E1|Reported Event|Riociguat (Adempas, BAY63-2521) up to 2.5 mg_IDT|Participants received Riociguat orally as a film-coated tablet up to 2.5mg three times daily (tid) (titration between 1.0 mg and 2.5 mg tid based on an individual dose titration (IDT) scheme) for 12 weeks
1002159|NCT00810641|B4|Baseline|Total|Total of all reporting groups
1002160|NCT00810641|B3|Baseline|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
1002161|NCT00810641|B2|Baseline|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
1002162|NCT00810641|B1|Baseline|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
1002163|NCT00810641|P3|Participant Flow|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
1002164|NCT00810641|P2|Participant Flow|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
1002165|NCT00810641|P1|Participant Flow|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
1002166|NCT00810641|O3|Outcome|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
1002167|NCT00810641|O2|Outcome|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
1002168|NCT00810641|O1|Outcome|Gufoni Maneuver|Gufoni maneuver for apogeotropic HC-BPPV
1002169|NCT00810641|E3|Reported Event|Sham Maneuver|sham maneuver for apogeotropci HC BPPV
1002170|NCT00810641|E2|Reported Event|Headshaking Maneuver|headshaking maneuver for apogeotropic HC BPPV
1002172|NCT00810602|B1|Baseline|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
1002173|NCT00810602|P2|Participant Flow|Phase 2|100 mg was selected as the Phase 2 dose. Participants were administered Vorinostat, 100 mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
1002174|NCT00810602|P1|Participant Flow|Phase 1|In the Phase 1 portion of the study, participants were administered Vorinostat, either 100 mg or 200mg, twice daily, orally, starting ten days prior to the stem cell infusion and continuing through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.
1002175|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
1002176|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
1002177|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
1002178|NCT00810602|O1|Outcome|Vorinostat Prophylaxis|"Vorinostat,combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
1002179|NCT00810602|E1|Reported Event|Vorinostat Prophylaxis|"Vorinostat, combined with standard GVHD prevention medications(tacrolimus, mycophenolate) for adults who received a reduced intensity, related donor stem cell transplant.~Vorinostat was administered daily starting ten days prior to the stem cell infusion and continued through day 100 post-HSCT. If tolerated, vorinostat will be continued until day 100 post-transplant,whether or not acute GVHD develops.~The phase 1 portion of the study tested two doses of vorinostat, 100 mg BID and 200 mg BID.The first ten patients received vorinostat 100 mg BID, followed by nine patients who received the 200 mg BID dose.~Although no dose-limiting toxicities were reached at the 200 mg BID dose, there was an increased incidence of protocol-driven dose modifications, primarily due to non-symptomatic thrombocytopenia after engraftment. Consequently, the 100 mg BID dose was selected as the phase 2 dose for the remaining patients."
1002180|NCT00810576|B1|Baseline|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
1002181|NCT00810576|P1|Participant Flow|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
1002182|NCT00810576|O1|Outcome|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
1002183|NCT00810576|E1|Reported Event|Vorinostat + Bortezomib|Vorinostat 200 mg orally twice on Days 1-14 + Bortezomib 1.3 mg/m^2 intravenously on Days 1, 4, 8, 11.
1002184|NCT00810511|B3|Baseline|Total|Total of all reporting groups
1002185|NCT00810511|B2|Baseline|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
1002186|NCT00810511|B1|Baseline|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
1002187|NCT00810511|P2|Participant Flow|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
1002189|NCT00810511|O2|Outcome|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
1002190|NCT00810511|O1|Outcome|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
1002191|NCT00810511|E2|Reported Event|Comfilcon A|Commercially marketed, spherical, silicone hydrogel contact lenses
1002192|NCT00810511|E1|Reported Event|Lotrafilcon A|Investigational, spherical, silicone hydrogel contact lenses
1002193|NCT00810394|B1|Baseline|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
1002194|NCT00810394|P1|Participant Flow|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
1002195|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
1002196|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
1002197|NCT00810394|O1|Outcome|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
1002198|NCT00810394|E1|Reported Event|Sorafenib|"Dose Re-Escalation Following a Dose Reduction~Sorafenib: Patients will be registered and started on the standard recommended dose-schedule for sorafenib (400 mg tablet by mouth twice a day continuously). Dose reductions will be instituted in the event of grade 3 or higher hematologic or non-hematologic toxicity or for any toxicity that is considered by the patient or physician as intolerable."
1002199|NCT00810368|B3|Baseline|Total|Total of all reporting groups
1002200|NCT00810368|B2|Baseline|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002201|NCT00810368|B1|Baseline|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002202|NCT00810368|P2|Participant Flow|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002203|NCT00810368|P1|Participant Flow|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002204|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002205|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002206|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002207|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002208|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002209|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002210|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002211|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002212|NCT00810368|O2|Outcome|Placebo Control Group|"Placebo control group~Placebo: Microcrystalline cellulose placebo tablets x2 daily"
1002213|NCT00810368|O1|Outcome|Carnosine Treatment Group|"Carnosine treatment group~Carnosine: 500mg Carnosine x2 daily"
1002214|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002215|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002216|NCT00810368|O2|Outcome|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002217|NCT00810368|O1|Outcome|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002218|NCT00810368|E2|Reported Event|Placebo Control Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Placebo. Controls who are aged and gender match and do not meet GWi and other exclusionary criteria microcrystalline cellulose placebo tablets x2 daily for 12 weeks.
1002219|NCT00810368|E1|Reported Event|Carnosine Treatment Group|A double blinded placebo controlled study. The pharmacy at Georgetown University Medical Center, will blind the Carnosine. Veterans who meet GWI criteria will be given 500mg Carnosine x2 daily for 12 weeks.
1002220|NCT00810355|B4|Baseline|Total|Total of all reporting groups
1002221|NCT00810355|B3|Baseline|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
1002222|NCT00810355|B2|Baseline|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
1002223|NCT00810355|B1|Baseline|Support Group|"Support group~Support Group: General support and problem solving for work activity"
1002224|NCT00810355|P3|Participant Flow|Cognitive Behavior Therapy and Cognitive Remediation|"Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
1002225|NCT00810355|P2|Participant Flow|Cognitive Behavior Therapy|Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work
1002226|NCT00810355|P1|Participant Flow|Support Group|Support Group: General support and problem solving for work activity
1002227|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
1002228|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
1002229|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
1002230|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
1002231|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
1002232|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
1002233|NCT00810355|O3|Outcome|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
1002234|NCT00810355|O2|Outcome|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
1002235|NCT00810355|O1|Outcome|Support Group|"Support group~Support Group: General support and problem solving for work activity"
1002236|NCT00810355|E3|Reported Event|Cognitive Behavior Therapy and Cognitive Remediation|"Cognitive Behavior Therapy and Cognitive Remediation~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work~Cognitive Remediation: Computerized training to enhance cognitive functioning."
1002237|NCT00810355|E2|Reported Event|Cognitive Behavior Therapy|"Cognitive Behavior Therapy~Support Group: General support and problem solving for work activity~Cognitive Behavior Therapy: Individual and group therapy focused on identifying and correcting maladaptive beliefs about work"
1002238|NCT00810355|E1|Reported Event|Support Group|"Support group~Support Group: General support and problem solving for work activity"
1002239|NCT00810342|B3|Baseline|Total|Total of all reporting groups
1002240|NCT00810342|B2|Baseline|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
1002241|NCT00810342|B1|Baseline|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
1002242|NCT00810342|P2|Participant Flow|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
1002377|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
1002243|NCT00810342|P1|Participant Flow|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
1002244|NCT00810342|O2|Outcome|2 - Physical Activity Standard|"Standard Website resources / information on physical activity~physical activity standard: standard print and website information on how to become more active"
1002245|NCT00810342|O1|Outcome|1- Physical Activity Tailored|"Tailored telephone counseling about how to become more physically active and goal setting. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
1002246|NCT00810342|O2|Outcome|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
1002247|NCT00810342|O1|Outcome|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
1002248|NCT00810342|E2|Reported Event|2 - Standard|"Website resources on physical activity~physical activity: standard print and website information on how to become more active"
1002249|NCT00810342|E1|Reported Event|1- Tailored|"Tailored telephone counseling about how to become more physically active. Email feedback on physical activity progress. Website listing resources new mothers can use to become more active.~physical activity tailored: tailored telephone counseling, email feedback, and website resources over 12 months"
1002250|NCT00810303|B1|Baseline|Study Group|whole study group: 12 healthy subjects
1002251|NCT00810303|P1|Participant Flow|Study Group|whole study group: 12 healthy subjects
1002252|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002253|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002254|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002255|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002256|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002257|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002258|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002259|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002260|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002261|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002262|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002263|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002264|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002265|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002266|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002267|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002268|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002269|NCT00810303|O1|Outcome|Study Group|whole study group: 12 healthy subjects
1002270|NCT00810303|E5|Reported Event|Ezetimibe and Efavirenz Multiple Dose|
1002271|NCT00810303|E4|Reported Event|Ezetimibe Multiple Dose and Efavirenz Single Dose|
1002272|NCT00810303|E3|Reported Event|Ezetimibe Alone Multiple Dose|
1002273|NCT00810303|E2|Reported Event|Efavirenz Alone Single Dose|
1002274|NCT00810303|E1|Reported Event|Study Group|whole study group: 12 healthy subjects
1002275|NCT00810277|B1|Baseline|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002276|NCT00810277|P1|Participant Flow|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002277|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002278|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002279|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002280|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002281|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002282|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002283|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002284|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002285|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002286|NCT00810277|O1|Outcome|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002287|NCT00810277|E1|Reported Event|Tocilizumab|Participants received tocilizumab at a dose of 8 milligram per kilogram (mg/kg) via intravenous infusion every 4 weeks up to 24 weeks.
1002288|NCT00810199|B3|Baseline|Total|Total of all reporting groups
1002378|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
1002379|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
1002380|NCT00810095|O1|Outcome|Treatment Group|All participants treated with the Test System
1002289|NCT00810199|B2|Baseline|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002290|NCT00810199|B1|Baseline|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002291|NCT00810199|P2|Participant Flow|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002292|NCT00810199|P1|Participant Flow|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002293|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002294|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002295|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002296|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002381|NCT00810095|E1|Reported Event|Treatment Group|All participants treated with the Test System
1002382|NCT00810082|B3|Baseline|Total|Total of all reporting groups
1002388|NCT00810082|O1|Outcome|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
1002467|NCT00809965|P1|Participant Flow|Placebo|One placebo tablet twice daily
1002468|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002297|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002298|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002299|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002300|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002301|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added
1002302|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
1002303|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
1002304|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
1002305|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002306|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002307|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002308|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002309|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002310|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002311|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002312|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002313|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002314|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002315|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002383|NCT00810082|B2|Baseline|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
1002469|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002316|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002317|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002318|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002319|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002320|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002321|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002322|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002323|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002384|NCT00810082|B1|Baseline|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
1002419|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002324|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002325|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002326|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002327|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002328|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002329|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002330|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002331|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002385|NCT00810082|P2|Participant Flow|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
1002470|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
1002332|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002333|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002334|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002335|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002336|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002337|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002338|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002339|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002386|NCT00810082|P1|Participant Flow|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
1002420|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002471|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002472|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002340|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002341|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002342|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002343|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
1002344|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added.
1002345|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
1002346|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
1002347|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002348|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002349|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002350|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002351|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002352|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002353|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002354|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002355|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002356|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002357|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002358|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002387|NCT00810082|O2|Outcome|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
1002465|NCT00809965|P3|Participant Flow|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002359|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002360|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002361|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002362|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002363|NCT00810199|O2|Outcome|Tocilizumab + Placebo|Tocilizumab 8 mg/kg intravenous once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study methotrexate dose for 24 weeks.
1002364|NCT00810199|O1|Outcome|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks.
1002365|NCT00810199|E2|Reported Event|Tocilizumab + Placebo|Tocilizumab 8 mg/kg (up to 800 mg) IV once every 4 weeks + weekly oral placebo to methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and placebo to methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded placebo to methotrexate if a flare occurred.
1002366|NCT00810199|E1|Reported Event|Tocilizumab + Methotrexate|Tocilizumab 8 mg/kg (up to 800 mg) intravenous (IV) once every 4 weeks + weekly oral methotrexate continuing at the patient's pre-study dose for 24 weeks. Patients taking oral corticosteroids remained on their pre-study dose (up to 10 mg/day). Week 24 to Week 52 the dose of tocilizumab and methotrexate remained the same. Based on DAS28 assessments, corticosteroid dose was adjusted and disease-modifying antirheumatic drug (DMARDS) added. Week 52 to Week 104, based on the DAS28 assessment, treatment was adjusted to one of four protocol specified treatment regimens: Treatment tapering, Continued treatment, Treatment intensification or Maintenance treatment. After Week 100, patients who discontinued tocilizumab because of remission were retreated with the last effective dose of tocilizumab or blinded methotrexate if a flare occurred.
1002367|NCT00810108|B3|Baseline|Total|Total of all reporting groups
1002368|NCT00810108|B2|Baseline|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
1002369|NCT00810108|B1|Baseline|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
1002370|NCT00810108|P2|Participant Flow|Crushed Then Whole Tablets|These subjects will take crushed tablets at Study Visit 1, and whole tablets at Study Visit 2.
1002371|NCT00810108|P1|Participant Flow|Whole Then Crushed Tablets|These subjects will take whole lopinavir tablets at Study Visit 1, and crushed tablets at Study Visit 2.
1002372|NCT00810108|O2|Outcome|All Subjects Taking Crushed Tablets|Lopinavir AUC from all subjects taking the crushed tablet
1002373|NCT00810108|O1|Outcome|All Subjects Taking Whole Tablets|Lopinavir AUC from all subjects taking the whole tablet
1002374|NCT00810108|E1|Reported Event|All Subjects|Data from all subjects combined
1002375|NCT00810095|B1|Baseline|Treatment Group|All participants treated with the Test System
1002376|NCT00810095|P1|Participant Flow|MindFrame System Treatment Group|All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset.
1002389|NCT00810082|E2|Reported Event|Physical Therapy Incuding ActiveStep|Physical therapy for fall prevention according to the therapist's standard practice but with the addition of the ActiveStep treadmill. The ActiveStep is a treadmill incorporating a harness safety device. It is integrated with a computer controlled by the therapist that produces perturbations simulating trips and slips. The purpose is to train the patient how to respond to the perturbations without falling.
1002390|NCT00810082|E1|Reported Event|Standard Physical Therapy Only|Physical therapy for fall prevention according to the clinician's standard practice.
1002391|NCT00810069|B3|Baseline|Total|Total of all reporting groups
1002392|NCT00810069|B2|Baseline|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002393|NCT00810069|B1|Baseline|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002394|NCT00810069|P3|Participant Flow|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002395|NCT00810069|P2|Participant Flow|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002396|NCT00810069|P1|Participant Flow|Escitalopram (Acute Treatment)|Escitalopram 10 milligrams (mg) per day for 4 weeks
1002397|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002398|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002399|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002400|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002401|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002402|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002403|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002404|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002405|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002406|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002407|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002408|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002409|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002410|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002411|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002412|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002413|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002414|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002415|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002416|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002417|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002418|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002466|NCT00809965|P2|Participant Flow|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002473|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
1002421|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002422|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002423|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002424|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002425|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002426|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002427|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002428|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002429|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002430|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002431|NCT00810069|O2|Outcome|Delayed Intervention|Escitalopram flexible dose (10 to 20 milligrams [mg] daily) for 4 weeks. Then in participants with no-response, switch treatment to duloxetine flexible dose (60 or 120 mg daily) for 8 weeks. In participants with a response continue treatment with escitalopram (10 to 20 milligrams [mg] daily) for 8 weeks.
1002432|NCT00810069|O1|Outcome|Early Intervention|Duloxetine flexible dose (60 or 120 milligrams [mg] daily) for 12 weeks
1002433|NCT00810069|E5|Reported Event|Delayed Intervention Non-Responders|Duloxetine 60 or 120 mg per day for 8 weeks.
1002434|NCT00810069|E4|Reported Event|Delayed Intervention Responders|Escitalopram 10 to 20 mg per day for 8 weeks.
1002435|NCT00810069|E3|Reported Event|Early Intervention (Double Blind)|Duloxetine flexible dose (60 or 120 milligram [mg] daily) for 12 weeks.
1002436|NCT00810069|E2|Reported Event|Delayed Intervention (Double Blind)|Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule[s]). Then, non-responders switched to duloxetine 60 or 120 mg per day for 8 weeks, and responders continued on escitalopram 10 to 20 mg per day for 8 weeks.
1002437|NCT00810069|E1|Reported Event|Escitalopram (Acute Treatment)|Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule)
1002438|NCT00810043|B3|Baseline|Total|Total of all reporting groups
1002439|NCT00810043|B2|Baseline|IBT-First|Use of the inflatable bone tamps prior to using the curette
1002440|NCT00810043|B1|Baseline|Curette-First|Use of the curette prior to use of the inflatable bone tamps
1002441|NCT00810043|P3|Participant Flow|Non-treated Patients|Patients who met the enrollment criteria at screening who had terminated prior to surgery or those who no longer met the inclusion criteria due to new fractures prior to surgery. These patients were never randomized to treatment because randomization was performed in the operating room.
1002442|NCT00810043|P2|Participant Flow|IBT-First|Use of the inflatable bone tamps prior to using the curette
1002443|NCT00810043|P1|Participant Flow|Curette-First|Use of the curette prior to use of the inflatable bone tamps
1002444|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
1002445|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
1002446|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
1002447|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
1002448|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
1002449|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
1002450|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
1002451|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
1002452|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
1002453|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
1002454|NCT00810043|O1|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
1002455|NCT00810043|O2|Outcome|IBT-First|Use of the inflatable bone tamps prior to using the curette
1002456|NCT00810043|O1|Outcome|Curette-First|Use of the curette prior to use of the inflatable bone tamps
1002457|NCT00810043|O2|Outcome|IBT-First|Use of inflatable bone tamps prior to use of the curette, followed by inflatable bone tamps
1002458|NCT00810043|O1|Outcome|Curette-First|Use of curette prior to use of inflatable bone tamps
1002459|NCT00810043|E2|Reported Event|IBT-First|Use of the inflatable bone tamps prior to using the curette
1002460|NCT00810043|E1|Reported Event|Curette-First|Use of the curette prior to use of the inflatable bone tamps
1002461|NCT00809965|B4|Baseline|Total|Total of all reporting groups
1002462|NCT00809965|B3|Baseline|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002463|NCT00809965|B2|Baseline|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002464|NCT00809965|B1|Baseline|Placebo|One placebo tablet twice daily
1020835|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1002474|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002475|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002476|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
1002477|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002478|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002479|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
1002480|NCT00809965|O3|Outcome|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002481|NCT00809965|O2|Outcome|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002482|NCT00809965|O1|Outcome|Placebo|One placebo tablet twice daily
1002483|NCT00809965|E3|Reported Event|Rivaroxaban 5 mg Bid|One rivaroxaban 5 mg tablet twice daily
1002484|NCT00809965|E2|Reported Event|Rivaroxaban 2.5 mg Bid|One rivaroxaban 2.5 mg tablet twice daily
1002485|NCT00809965|E1|Reported Event|Placebo|One placebo tablet twice daily
1002486|NCT00809926|B3|Baseline|Total|Total of all reporting groups
1002487|NCT00809926|B2|Baseline|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002488|NCT00809926|B1|Baseline|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002489|NCT00809926|P2|Participant Flow|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002490|NCT00809926|P1|Participant Flow|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002491|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002492|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002493|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002494|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002495|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002496|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002497|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002498|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002499|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002500|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002501|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002502|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002503|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002504|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002505|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002506|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002507|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002508|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002509|NCT00809926|O2|Outcome|Valsartan|For the first 2 weeks patients received Valsartan 160 mg. For the remaining 6 weeks, all patients received Valsartan 320 mg (forced titration).
1002510|NCT00809926|O1|Outcome|Valsartan/Aliskiren|For the first 2 weeks patients received Valsartan/aliskiren (160/150mg). For the remaining 6 weeks, all patients received Valsartan/aliskiren 320/300mg (forced titration).
1002511|NCT00809926|E2|Reported Event|Valsartan|Valsartan (160mg) for 2weeks followed by forced titration toValsartan (320mg) for the remaining 6 weeks
1002512|NCT00809926|E1|Reported Event|Valsartan/ Aliskiren|Valsartan/aliskiren (160/150mg) for 2 weeks followed by forced titration to valsartan/aliskiren (320/300mg) for the remaining 6 weeks
1002513|NCT00809848|B6|Baseline|Total|Total of all reporting groups
1002514|NCT00809848|B5|Baseline|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
1002515|NCT00809848|B4|Baseline|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
1020836|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1002516|NCT00809848|B3|Baseline|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
1002517|NCT00809848|B2|Baseline|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
1002518|NCT00809848|B1|Baseline|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
1002519|NCT00809848|P5|Participant Flow|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
1002520|NCT00809848|P4|Participant Flow|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
1002521|NCT00809848|P3|Participant Flow|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
1002522|NCT00809848|P2|Participant Flow|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
1002523|NCT00809848|P1|Participant Flow|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
1002524|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
1002525|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
1002526|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
1002527|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
1002528|NCT00809848|O1|Outcome|AGN 210669 Non-preserved Ophthalmic Solution, 0.075%|AGN 210669 non-preserved ophthalmic solution, 0.075%. One drop in each eye each morning once-daily for 2 weeks.
1002529|NCT00809848|O5|Outcome|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
1002530|NCT00809848|O4|Outcome|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
1002531|NCT00809848|O3|Outcome|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
1002532|NCT00809848|O2|Outcome|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
1002533|NCT00809848|O1|Outcome|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
1002534|NCT00809848|E5|Reported Event|AGN-210669 Vehicle Ophthalmic Solution|AGN-210669 vehicle non-preserved ophthalmic solution. One drop in both eyes each morning once-daily for 2 weeks.
1002535|NCT00809848|E4|Reported Event|Bimatoprost Ophthalmic Solution 0.03%|Bimatoprost ophthalmic solution 0.03%. One drop in both eyes each morning once-daily for 2 weeks.
1002536|NCT00809848|E3|Reported Event|AGN-210669 Ophthalmic Solution, 0.025%|AGN-210669 non-preserved ophthalmic solution, 0.025%. One drop in both eyes each morning once-daily for 2 weeks.
1002537|NCT00809848|E2|Reported Event|AGN-210669 Ophthalmic Solution, 0.05%|AGN-210669 non-preserved ophthalmic solution, 0.05%. One drop in both eyes each morning once-daily for 2 weeks.
1002538|NCT00809848|E1|Reported Event|AGN-210669 Ophthalmic Solution, 0.075%|AGN-210669 non-preserved ophthalmic solution, 0.075%. One drop in both eyes each morning once-daily for 2 weeks.
1002539|NCT00809835|B5|Baseline|Total|Total of all reporting groups
1002540|NCT00809835|B4|Baseline|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
1002541|NCT00809835|B3|Baseline|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
1002542|NCT00809835|B2|Baseline|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
1002543|NCT00809835|B1|Baseline|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
1002544|NCT00809835|P4|Participant Flow|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
1002545|NCT00809835|P3|Participant Flow|Placebo and CBT|TAU plus computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
1002546|NCT00809835|P2|Participant Flow|Galantamine Only|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
1002569|NCT00809809|O2|Outcome|Placebo Treatment|Placebo medication - Swabs identical to medication group
1002570|NCT00809809|O1|Outcome|Active Treatment|Active medication - Zinc Swabs
1020837|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1002547|NCT00809835|P1|Participant Flow|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
1002548|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
1002549|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
1002550|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
1002551|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
1002552|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
1002553|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
1002554|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
1002555|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
1002556|NCT00809835|O4|Outcome|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
1002557|NCT00809835|O3|Outcome|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
1002558|NCT00809835|O2|Outcome|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
1002559|NCT00809835|O1|Outcome|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
1002560|NCT00809835|E4|Reported Event|Placebo Only|Standard Treatment plus placebo for cocaine abusing or dependent methadone-maintained individuals. This consists of daily methadone visits plus one individual and one group session per week, and patients may participate in additional treatments such as HIV education and treatment. The counseling program's theoretical orientation is described as client-centered.
1002561|NCT00809835|E3|Reported Event|Placebo and CBT|Computer assisted CBT plus placebo. All participants assigned to this condition will also be offered up to 60 minutes per week to work with the CBT for CBT program, onsite at the clinic, in a private space and using a computer provided by the research project. Patients will have the choice of how they choose to use the computer, that is, in two 30-minute sessions or one one-hour session.
1002562|NCT00809835|E2|Reported Event|Galantamine|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine"
1002563|NCT00809835|E1|Reported Event|Galantamine and CBT|"Drug: Galantamine Daily 8 mg galantamine capsule~Other Names:~Nivalin, Razadyne, Razadyne ER, Reminyl, Lycoremine~Behavioral: Computer Assisted Cognitive Behavioral Therapy (CBT) CBT a psychotherapeutic approach that addresses dysfunctional emotions, maladaptive behaviors and cognitive processes and contents through a number of goal-oriented, explicit systematic procedures. The name refers to behavior therapy, cognitive therapy, and to therapy based upon a combination of basic behavioral and cognitive principles and research."
1002564|NCT00809809|B3|Baseline|Total|Total of all reporting groups
1002565|NCT00809809|B2|Baseline|Placebo Treatment|Placebo medication - Swabs identical to medication group
1002566|NCT00809809|B1|Baseline|Active Treatment|Active medication - Zinc Swabs
1002567|NCT00809809|P2|Participant Flow|Placebo Treatment|Placebo medication - Swabs identical to medication group
1002568|NCT00809809|P1|Participant Flow|Active Treatment|Active medication - Zinc Swabs
1020838|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1002571|NCT00809809|E2|Reported Event|Placebo Treatment|Placebo medication - Swabs identical to medication group
1002572|NCT00809809|E1|Reported Event|Active Treatment|Active medication - Zinc Swabs
1002573|NCT00809757|B4|Baseline|Total|Total of all reporting groups
1002574|NCT00809757|B3|Baseline|Levalbuterol UDV|Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002575|NCT00809757|B2|Baseline|Levalbuterol MDI|Levalbuterol MDI TID
1002576|NCT00809757|B1|Baseline|Placebo|Placebo Placebo MDI TID
1002577|NCT00809757|P3|Participant Flow|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
1002578|NCT00809757|P2|Participant Flow|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
1002579|NCT00809757|P1|Participant Flow|Placebo|Placebo: Placebo (2 actuations)
1002580|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002581|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002582|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002583|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002584|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002585|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002586|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002587|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002588|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002589|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002590|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002591|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002592|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002593|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002594|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002595|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002596|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002597|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002598|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002599|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002600|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
1002601|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002602|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002603|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002604|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002605|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002606|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002607|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002608|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002609|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
1002610|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002611|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002612|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002613|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002614|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002615|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002616|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002617|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002618|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002619|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002620|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002621|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002622|NCT00809757|O3|Outcome|Levalbuterol UDV|0.31 ug Levalbuterol UDV TID LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002623|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002624|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002625|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002626|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002627|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002628|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002629|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002630|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1020839|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1002631|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002632|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002633|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002634|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002635|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002636|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002637|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002638|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002639|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002640|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
1002641|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002642|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
1002643|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002644|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002645|NCT00809757|O1|Outcome|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
1002646|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
1002647|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002648|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002649|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV 0.31 ug Levalbuterol UDV TID
1002650|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002651|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002652|NCT00809757|O3|Outcome|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002653|NCT00809757|O2|Outcome|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002654|NCT00809757|O1|Outcome|Placebo|"PBO MDI~Placebo: Placebo (2 actuations) MDI TID"
1002655|NCT00809757|O3|Outcome|Levalbuterol UDV|"0.31 ug Levalbuterol UDV TID~Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID"
1002656|NCT00809757|O2|Outcome|Levalbuterol MDI|"90 ug Levalbuterol (2 actuations)~Levalbuterol: 90 ug Levalbuterol (2 actuations)"
1002657|NCT00809757|O1|Outcome|Placebo|Placebo: Placebo (2 actuations)
1002658|NCT00809757|E3|Reported Event|Levalbuterol UDV|LEV UDV Levalbuterol UDV TID: 0.31 ug Levalbuterol UDV TID
1002659|NCT00809757|E2|Reported Event|Levalbuterol MDI|LEV MDI Levalbuterol: 90 ug Levalbuterol (2 actuations) MDI TID
1002660|NCT00809757|E1|Reported Event|Placebo|PBO MDI Placebo: Placebo (2 actuations) MDI TID
1002661|NCT00809614|B3|Baseline|Total|Total of all reporting groups
1002662|NCT00809614|B2|Baseline|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002663|NCT00809614|B1|Baseline|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002664|NCT00809614|P2|Participant Flow|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002665|NCT00809614|P1|Participant Flow|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002666|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002667|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002668|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002669|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002670|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002671|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002672|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002673|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002674|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002675|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002676|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002677|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002678|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002679|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002680|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002681|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002682|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002683|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002684|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002685|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002686|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002687|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1020840|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1002688|NCT00809614|O2|Outcome|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002689|NCT00809614|O1|Outcome|AIN457 (2x 10mg/kg)|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002690|NCT00809614|E2|Reported Event|Placebo|Each patient received 10 mg/kg of matching placebo intravenously, on Day 1 and Day 22.
1002691|NCT00809614|E1|Reported Event|AIN457 2x10mg/kg|Each patient received 10 mg/kg AIN457 intravenously, on Day 1 and Day 22.
1002692|NCT00809523|B3|Baseline|Total|Total of all reporting groups
1002693|NCT00809523|B2|Baseline|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
1002694|NCT00809523|B1|Baseline|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
1002695|NCT00809523|P2|Participant Flow|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
1002696|NCT00809523|P1|Participant Flow|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
1002697|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
1002698|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
1002699|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
1002700|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
1002701|NCT00809523|O2|Outcome|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
1002702|NCT00809523|O1|Outcome|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
1002703|NCT00809523|E2|Reported Event|LED Phototherapy Device|Light-emitting photodiode light treatment device, used for 30 min before 8 am
1002704|NCT00809523|E1|Reported Event|Inactivated Negative Ion Generator|Equivalent exposure to inactivated Negative Ion Generator
1002705|NCT00809471|B4|Baseline|Total|Total of all reporting groups
1002706|NCT00809471|B3|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1002707|NCT00809471|B2|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1002708|NCT00809471|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1002709|NCT00809471|P3|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1002710|NCT00809471|P2|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1002711|NCT00809471|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1002712|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1002713|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1002714|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1002715|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1002716|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1002717|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1002718|NCT00809471|O3|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1002719|NCT00809471|O2|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1002720|NCT00809471|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1002721|NCT00809471|E3|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1002722|NCT00809471|E2|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1002723|NCT00809471|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1002724|NCT00809458|B3|Baseline|Total|Total of all reporting groups
1002725|NCT00809458|B2|Baseline|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
1002726|NCT00809458|B1|Baseline|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
1002727|NCT00809458|P2|Participant Flow|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
1002728|NCT00809458|P1|Participant Flow|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
1002729|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
1002730|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
1002731|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
1002732|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
1002733|NCT00809458|O2|Outcome|Arm 2 (Placebo)|Placebo (same vehicle as used for vitamin E): one placebo tablet daily
1002734|NCT00809458|O1|Outcome|Arm 1 (Vitamin E)|Vitamin E administration: one 400 IU tablet of vitamin E daily
1002735|NCT00809458|E2|Reported Event|Arm 2|"Placebo (same vehicle as used for vitamin E)~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
1002736|NCT00809458|E1|Reported Event|Arm 1 (Vitamin E)|"Vitamin E~Vitamin E: Patients will take one 400 IU tablet of vitamin E or a placebo daily. Patients will continue on this treatment from the time of randomization to the day before surgery or the brachytherapy procedure. This is expected to be between 4 to 6 weeks. The patient will continue with his regular medications. The vitamin E will be supplied by the clinical trial through the UNM CRTC pharmacy."
1002737|NCT00809445|B4|Baseline|Total|Total of all reporting groups
1003134|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1002738|NCT00809445|B3|Baseline|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
1002739|NCT00809445|B2|Baseline|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
1002740|NCT00809445|B1|Baseline|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
1002741|NCT00809445|P3|Participant Flow|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
1002742|NCT00809445|P2|Participant Flow|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
1002743|NCT00809445|P1|Participant Flow|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
1002744|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
1002745|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
1002746|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
1002747|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
1002748|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
1002749|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
1002750|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
1002751|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
1002752|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
1002753|NCT00809445|O3|Outcome|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
1002754|NCT00809445|O2|Outcome|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
1002755|NCT00809445|O1|Outcome|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
1002756|NCT00809445|E3|Reported Event|HIV Rapid Test and Info|On- site HIV rapid test & information : Participants will be offered an on-site oral fluid HIV rapid test with basic info.
1002757|NCT00809445|E2|Reported Event|HIV Rapid Test & Counseling|On-site HIV rapid test and brief, prevention counseling : Participants will be offered an on-site oral fluid HIV rapid test with brief prevention counseling that addresses both risk reduction and motivation to be HIV tested based on an evidence-based counseling approach.
1002758|NCT00809445|E1|Reported Event|HIV Testing Referral|Referral for off-site HIV testing : Participants will be offered a referral list of HIV testing agencies in the community.
1002759|NCT00809328|B1|Baseline|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002760|NCT00809328|P1|Participant Flow|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002761|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002762|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002763|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002764|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002765|NCT00809328|O1|Outcome|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002766|NCT00809328|E1|Reported Event|Azithromycin|Azithromycin switch therapy (from 500 mg intravenous azithromycin once daily for 2 to 5 days to 500 mg oral azithromycin once daily to complete a total of 7 to 10 days therapy)
1002767|NCT00809276|B1|Baseline|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
1002768|NCT00809276|P1|Participant Flow|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
1003263|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
1002769|NCT00809276|O1|Outcome|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
1002770|NCT00809276|E1|Reported Event|BuFlu Transplant|Myeloablative bone marrow transplant with busulfan and fludarabine conditioning Post-transplantation cyclophosphamide as single-agent graft-versus-host-disease prophylaxis
1002771|NCT00809185|B1|Baseline|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
1002772|NCT00809185|P1|Participant Flow|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
1002773|NCT00809185|O1|Outcome|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
1002774|NCT00809185|E1|Reported Event|RAD001(Everolimus)|drug will be administered at 10mg by mouth for 21 days followed by a 7 day rest period
1002775|NCT00809159|B5|Baseline|Total|Total of all reporting groups
1002776|NCT00809159|B4|Baseline|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002777|NCT00809159|B3|Baseline|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002778|NCT00809159|B2|Baseline|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002779|NCT00809159|B1|Baseline|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002780|NCT00809159|P6|Participant Flow|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002781|NCT00809159|P5|Participant Flow|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002782|NCT00809159|P4|Participant Flow|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002783|NCT00809159|P3|Participant Flow|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002784|NCT00809159|P2|Participant Flow|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002785|NCT00809159|P1|Participant Flow|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002786|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002787|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002788|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002789|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002790|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002791|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002792|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002793|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002794|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002795|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002796|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002797|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002798|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002799|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002800|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/Kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002801|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002802|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002803|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002804|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002805|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002806|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002807|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002808|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002809|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1020841|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1002810|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002811|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002812|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002813|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002814|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002815|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002816|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002817|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002818|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002819|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002820|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002821|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002822|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002823|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002824|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002825|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002826|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002827|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002828|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002829|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002830|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002831|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002832|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002833|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002834|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002835|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002836|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002837|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002838|NCT00809159|O4|Outcome|Part 1 and 2 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002839|NCT00809159|O3|Outcome|Part 1 and 2 - AIN457 0.1 mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002840|NCT00809159|O2|Outcome|Part 1 and 2 - AIN457 1.0 mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002841|NCT00809159|O1|Outcome|Parts 1 and 2 - AIN457A 10 mg/kg|AIN457A 10 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22.
1002842|NCT00809159|O2|Outcome|Part 1 - Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002843|NCT00809159|O1|Outcome|Part 1 - AIN457A 10 mg/kg|AIN457A 10.0 mg/kg was administered intravenously as a single dose.
1002844|NCT00809159|E4|Reported Event|Placebo|Placebo to AIN457A was administered intravenously as a single dose
1002845|NCT00809159|E3|Reported Event|AIN457 2x0.1mg/kg|AIN457A 0.1 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002846|NCT00809159|E2|Reported Event|AIN457 2x1.0mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002847|NCT00809159|E1|Reported Event|AIN457 2x10mg/kg|AIN457A 1.0 mg/kg was administered intravenously as 2 doses 21 days apart, i.e. the first dose on day 1 and the second dose on day 22
1002848|NCT00809146|B3|Baseline|Total|Total of all reporting groups
1002849|NCT00809146|B2|Baseline|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
1020842|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1002850|NCT00809146|B1|Baseline|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
1002851|NCT00809146|P2|Participant Flow|Intravenous (IV) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intravenous route of administration. IV administration of lorazepam 2 mg for subjects under estimated weight of 40 kg or midazolam 4 mg for subjects with estimated weight of 40 kg or above, IM administration by autoinjector of matching volume of saline.
1002852|NCT00809146|P1|Participant Flow|Intramuscular (IM) Anticonvulsant|This group gets active treatment with an anticonvulsant by the intramuscular route of administration. IM administration by autoinjector of midazolam 5 mg for subjects under estimated weight of 40 kg or midazolam 10 mg for subjects with estimated weight of 40 kg or above, IV administration of matching volume of IV flush.
1002853|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002854|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002855|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002856|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002857|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002858|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002859|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002860|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002861|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002862|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002863|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002864|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002865|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002866|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002867|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002868|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002869|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002870|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002871|NCT00809146|O2|Outcome|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002872|NCT00809146|O1|Outcome|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002873|NCT00809146|E2|Reported Event|IV Lorazepam|Subjects in whom the study IV infusion contained active treatment with lorazepam
1002874|NCT00809146|E1|Reported Event|IM Midazolam|Subjects in whom the study IM autoinjector contained active treatment with midazolam
1002875|NCT00809133|B15|Baseline|Total|Total of all reporting groups
1002876|NCT00809133|B14|Baseline|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002877|NCT00809133|B13|Baseline|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002878|NCT00809133|B12|Baseline|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002879|NCT00809133|B11|Baseline|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002880|NCT00809133|B10|Baseline|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002881|NCT00809133|B9|Baseline|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002882|NCT00809133|B8|Baseline|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002883|NCT00809133|B7|Baseline|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002884|NCT00809133|B6|Baseline|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002885|NCT00809133|B5|Baseline|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002886|NCT00809133|B4|Baseline|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002887|NCT00809133|B3|Baseline|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002888|NCT00809133|B2|Baseline|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002889|NCT00809133|B1|Baseline|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002890|NCT00809133|P14|Participant Flow|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002891|NCT00809133|P13|Participant Flow|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002892|NCT00809133|P12|Participant Flow|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002893|NCT00809133|P11|Participant Flow|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002894|NCT00809133|P10|Participant Flow|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002895|NCT00809133|P9|Participant Flow|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002896|NCT00809133|P8|Participant Flow|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002897|NCT00809133|P7|Participant Flow|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002898|NCT00809133|P6|Participant Flow|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002899|NCT00809133|P5|Participant Flow|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002900|NCT00809133|P4|Participant Flow|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002901|NCT00809133|P3|Participant Flow|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002902|NCT00809133|P2|Participant Flow|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002903|NCT00809133|P1|Participant Flow|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002904|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002905|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002906|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002907|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002908|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002909|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002910|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002911|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002912|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002913|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002914|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002915|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002916|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002917|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002918|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002919|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002920|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002921|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002922|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002923|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002924|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002925|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002926|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002927|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002928|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002929|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003132|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1002930|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002931|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002932|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002933|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002934|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002935|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002936|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002937|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002938|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002939|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002940|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002941|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002942|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002943|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002944|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002945|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002946|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002947|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002948|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002949|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002950|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002951|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002952|NCT00809133|O4|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1020843|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1002953|NCT00809133|O3|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002954|NCT00809133|O2|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002955|NCT00809133|O1|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002956|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002957|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002958|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002959|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002960|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002961|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002962|NCT00809133|O2|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002963|NCT00809133|O1|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1002964|NCT00809133|O2|Outcome|Part B: End of 2nd Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
1002965|NCT00809133|O1|Outcome|Part B: End of 1st Infusion of Cycle 1|Dose escalation of Bevacizumab administered as intravenous infusion to 5 mg/kg. Bevacizumab administered on Days 1 and 15 of a 28-day cycle.
1002966|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002967|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002968|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002969|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002970|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002971|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002972|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002973|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002974|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003264|NCT00808483|O1|Outcome|Walking Skilll Training Group|12 sessions of participation in the supervised walking skilll training program
1002975|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002976|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002977|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002978|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002979|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002980|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002981|NCT00809133|O5|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002982|NCT00809133|O4|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002983|NCT00809133|O3|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002984|NCT00809133|O2|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002985|NCT00809133|O1|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1002986|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002987|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002988|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002989|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002990|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002991|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002992|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002993|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002994|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002995|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002996|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002997|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1002998|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1002999|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003000|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003001|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003002|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003003|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003004|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003005|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003006|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003007|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003008|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003009|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003010|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003011|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003012|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003013|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003014|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003015|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003016|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003017|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003018|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003019|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003020|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003133|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003021|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003022|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003023|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003024|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003025|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003026|NCT00809133|O14|Outcome|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003027|NCT00809133|O13|Outcome|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003028|NCT00809133|O12|Outcome|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003029|NCT00809133|O11|Outcome|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003030|NCT00809133|O10|Outcome|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003031|NCT00809133|O9|Outcome|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003032|NCT00809133|O8|Outcome|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003033|NCT00809133|O7|Outcome|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003034|NCT00809133|O6|Outcome|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003035|NCT00809133|O5|Outcome|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003036|NCT00809133|O4|Outcome|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003037|NCT00809133|O3|Outcome|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003038|NCT00809133|O2|Outcome|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003039|NCT00809133|O1|Outcome|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003040|NCT00809133|E14|Reported Event|Part D: A20P175C6 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC6 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003041|NCT00809133|E13|Reported Event|Part D: A40P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003042|NCT00809133|E12|Reported Event|Part D: A30P175C5 (Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003043|NCT00809133|E11|Reported Event|Part D: A20P175C5 ( Afatinib + Paclitaxel + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Carboplatin AUC5 (intravenous infusion) and Paclitaxel 175 mg/m2 (intravenous infusion) which were administered on Day 1 of a 21-day cycle.
1003044|NCT00809133|E10|Reported Event|Part C: A40C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 40 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003045|NCT00809133|E9|Reported Event|Part C: A20C6 (Afatinib + Carboplatin)|Afatinib (film-coated tablet) 20 mg qd (once daily) administered orally in combination with Carboplatin (intravenous infusion) at a dose targeting an AUC (Area Under the Concentration-time curve) of 6 mg/mL min (AUC6) administered on Day 1 of a 21-day cycle.
1003046|NCT00809133|E8|Reported Event|Part B: A20P80B10 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 10 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003047|NCT00809133|E7|Reported Event|Part B: A20P80B7.5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 7.5 mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003048|NCT00809133|E6|Reported Event|Part B: A40P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003049|NCT00809133|E5|Reported Event|Part B: A30P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 30 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003050|NCT00809133|E4|Reported Event|Part B: A20P80B5 (Afatinib + Paclitaxel + Bevacizumab)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8 and 15 and Bevacizumab 5mg/kg administered as intravenous infusion on Days 1 and 15 of a 28-day cycle.
1003051|NCT00809133|E3|Reported Event|Part A: A50P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 50 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003052|NCT00809133|E2|Reported Event|Part A: A40P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 40 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003053|NCT00809133|E1|Reported Event|Part A: A20P80 (Afatinib + Paclitaxel)|Afatinib (film-coated tablet) 20 mg qd (once daily) was administered orally in combination with Paclitaxel 80 mg/m2 administered as intravenous infusion on Days 1, 8, and 15 of a 28-day cycle.
1003054|NCT00809094|B3|Baseline|Total|Total of all reporting groups
1003055|NCT00809094|B2|Baseline|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003056|NCT00809094|B1|Baseline|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003057|NCT00809094|P2|Participant Flow|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003058|NCT00809094|P1|Participant Flow|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003059|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003060|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003061|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003062|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003063|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003064|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003065|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003066|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003067|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003068|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003069|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003070|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003071|NCT00809094|O2|Outcome|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003072|NCT00809094|O1|Outcome|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003073|NCT00809094|E2|Reported Event|Placebo|Identically packaged effervescent tablets that contained only the carrier were provided in blister packs by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada)
1003074|NCT00809094|E1|Reported Event|Study Drug|N-acetylcysteine (NAC) :PharmaNAC® 900 mg effervescent tablets in blister packs were supplied by BioAdvantex Pharma, Inc. (Mississauga, ON, Canada).
1003075|NCT00809055|B3|Baseline|Total|Total of all reporting groups
1003076|NCT00809055|B2|Baseline|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003077|NCT00809055|B1|Baseline|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003078|NCT00809055|P2|Participant Flow|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003079|NCT00809055|P1|Participant Flow|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003080|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003081|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003082|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003083|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003084|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003085|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003086|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003087|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003088|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003089|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003090|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003091|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003092|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003093|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003094|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003095|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003555|NCT00808028|B2|Baseline|rLP2086 60 mcg|Given on a 0, 2-, 6-month schedule in Stage 1.
1003096|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003097|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003098|NCT00809055|O2|Outcome|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003099|NCT00809055|O1|Outcome|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003100|NCT00809055|E2|Reported Event|Standard Dose Caffeine|"Loading dose 20mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo, followed 12 hours later with 10mg/kg IV caffeine citrate, followed 12 hours later with D5W placebo.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003101|NCT00809055|E1|Reported Event|High Dose Caffeine|"Loading dose 40mg/kg IV caffeine citrate, followed 12 hours later by 20mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate, followed 12 hours later by 10mg/kg IV caffeine citrate.~Caffeine citrate: Caffeine to be administered as outlined to compare efficacy of different dosages."
1003102|NCT00808899|B1|Baseline|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
1003103|NCT00808899|P1|Participant Flow|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
1003104|NCT00808899|O1|Outcome|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
1003105|NCT00808899|E1|Reported Event|Temsirolimus With Irinotecan|Participants enrolled in the Temsiolimus and Irinotecan group were high-risk neuroblastoma patients.
1003106|NCT00808834|B1|Baseline|Overall|This reporting group includes all enrolled and exposed subjects.
1003107|NCT00808834|P2|Participant Flow|Lotrafilcon A / Senofilcon A|Lotrafilcon A, followed by Senofilcon A
1003108|NCT00808834|P1|Participant Flow|Senofilcon A / Lotrafilcon A|Senofilcon A, followed by Lotrafilcon A
1003109|NCT00808834|O2|Outcome|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
1003110|NCT00808834|O1|Outcome|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
1003111|NCT00808834|E2|Reported Event|Lotrafilcon A|Investigational, silicone hydrogel, spherical, soft contact lens
1003112|NCT00808834|E1|Reported Event|Senofilcon A|Commercially marketed, silicone hydrogel, spherical, soft contact lens
1003113|NCT00808808|B4|Baseline|Total|Total of all reporting groups
1003114|NCT00808808|B3|Baseline|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1003115|NCT00808808|B2|Baseline|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003116|NCT00808808|B1|Baseline|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1003117|NCT00808808|P3|Participant Flow|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1003118|NCT00808808|P2|Participant Flow|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003119|NCT00808808|P1|Participant Flow|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1003120|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as male.
1003121|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as male.
1003122|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as college graduates.
1003123|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as college graduates.
1003124|NCT00808808|O2|Outcome|Vaccinated With TIV|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with TIV, and who self-identified as white.
1003125|NCT00808808|O1|Outcome|Vaccinated With FluMist|Characteristics of vaccinated employees 18-49 years of age who were eligible for FluMist and chose vaccination with FluMist, and who self-identified as white
1003126|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1003127|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003128|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1003129|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1003130|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003131|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1003672|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
1003135|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1003136|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003137|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1003138|NCT00808808|O3|Outcome|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1003139|NCT00808808|O2|Outcome|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003140|NCT00808808|O1|Outcome|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1003141|NCT00808808|E3|Reported Event|Arm C (Choice Plus)|An intervention arm offering choice of TIV or FluMist with enhanced advertisement and additional incentives for receiving an influenza vaccination
1003142|NCT00808808|E2|Reported Event|Arm B (Choice)|An intervention arm offering choice of TIV or FluMist with baseline advertisement, including advertisement to highlight the availability of FluMist
1003143|NCT00808808|E1|Reported Event|Arm A (Control)|A control arm of usual care offering TIV with baseline advertisement
1003144|NCT00808769|B1|Baseline|All Study Participants|
1003145|NCT00808769|P2|Participant Flow|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
1003146|NCT00808769|P1|Participant Flow|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
1003147|NCT00808769|O2|Outcome|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
1003148|NCT00808769|O1|Outcome|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
1003149|NCT00808769|E2|Reported Event|Prilosec OTC® Then Zegerid®|Prilosec OTC® (omeprazole magnesium 20.6 mg) then Zegerid® (20 mg omeprazole/sodium bicarbonate)
1003150|NCT00808769|E1|Reported Event|Zegerid® Then Prilosec OTC®|Zegerid® (20 mg omeprazole/sodium bicarbonate) then Prilosec OTC® (20.6 mg omeprazole magnesium)
1003151|NCT00808639|B1|Baseline|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
1003152|NCT00808639|P1|Participant Flow|Dose Dense MVAC|Dose-dense methotrexate, vinblastine, doxorubicin, and cisplatin (ddMVAC)
1003153|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
1003154|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
1003155|NCT00808639|O1|Outcome|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
1003156|NCT00808639|E1|Reported Event|Dose Dense MVAC|"Methotrexate: intravenously 30mg/m2 over 30 minutes~Doxorubicin: intravenously 30mg/ms over 15 minutes~vinblastine: intravenously 3mg/m2 over 30 minutes~cisplatin: intravenously 70mg/m2 in 1 liter NS with 12.5gm Mannitol over 2 hours after vinblastine completion~Pegfilgrastim: Given subcutaneously 24 hours after last chemotherapy dose"
1003157|NCT00808509|B3|Baseline|Total|Total of all reporting groups
1003158|NCT00808509|B2|Baseline|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003159|NCT00808509|B1|Baseline|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003160|NCT00808509|P2|Participant Flow|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003161|NCT00808509|P1|Participant Flow|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003162|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003163|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003265|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
1003673|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
1003164|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003165|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003166|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003167|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003168|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003169|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003170|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003171|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003172|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003173|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003174|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003175|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003176|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003177|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003178|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003179|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003180|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003181|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003182|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003674|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
1003183|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003184|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003185|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003186|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003187|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003188|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003189|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003190|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003191|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003192|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003193|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003194|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003195|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003196|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003197|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003198|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003199|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003200|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003201|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003266|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
1003202|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003203|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003204|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003205|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003206|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003207|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003208|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003209|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003210|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003211|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003212|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003213|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003214|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003215|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003216|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003217|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003218|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003219|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003220|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003675|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
1003221|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003222|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003223|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003224|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003225|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003226|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003227|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003228|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003229|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003230|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003231|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003232|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003233|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003234|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003235|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003236|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003237|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003238|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003239|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003267|NCT00808483|O2|Outcome|Control Group|No sessions of participation in the walking skill training program
1003240|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003241|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003242|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003243|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003244|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003245|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003246|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003247|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003248|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003249|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003250|NCT00808509|O2|Outcome|Methotrexate|Participants discontinued adalimumab and continued to receive methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003251|NCT00808509|O1|Outcome|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003252|NCT00808509|E4|Reported Event|Methotrexate-Including Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks. Participants with a significant increase in RA disease activity were re-instituted to adalimumab 40 mg every other week (rescue arm). After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003253|NCT00808509|E3|Reported Event|Methotrexate-Rescue Arm|Participants received methotrexate alone for 52 weeks, but due to an increase in disease activity were reinstituted with adalimumab 40 mg subcutaneously every other week during the 52-week randomized period. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003254|NCT00808509|E2|Reported Event|Methotrexate-Excluding Rescue|Participants received methotrexate (at least 10 mg/week orally or subcutaneously) alone for 52 weeks and were not reinstituted to adalimumab as rescue treatment. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003255|NCT00808509|E1|Reported Event|Adalimumab + MTX|Participants continued treatment with adalimumab 40 mg subcutaneously every other week plus methotrexate (at least 10 mg/week orally or subcutaneously) for 52 weeks. After Week 52 an observational extension period ensued where participants were treated at the discretion of the investigator.
1003256|NCT00808483|B3|Baseline|Total|Total of all reporting groups
1003257|NCT00808483|B2|Baseline|Control Group|No participation in the walking skill training group
1003258|NCT00808483|B1|Baseline|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and sit-to-stand with guidance and supervision from a physiotherapist."
1003259|NCT00808483|P2|Participant Flow|Control Group|No participation in the walking skill training group
1003260|NCT00808483|P1|Participant Flow|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
1003261|NCT00808483|O2|Outcome|Control Group|No session of participation in the walking skill training program
1003262|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
1003268|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training program
1003269|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
1003270|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in the supervised walking skill training group
1003271|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
1003272|NCT00808483|O1|Outcome|Walking Skill Training Group|12 sessions of participation in a supervised walking skill training program
1003273|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
1003274|NCT00808483|O1|Outcome|Walking Skill Training Group|12 session of participation in the supervised walking skill training program
1003275|NCT00808483|O2|Outcome|Control Group|No participation in the walking skill training program
1003276|NCT00808483|O1|Outcome|Walking Skill Training Group|"12 sessions of participation in the supervised walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
1003277|NCT00808483|E2|Reported Event|Control Group|No participation in the walking skill training group
1003278|NCT00808483|E1|Reported Event|Walking Skill Training Group|"12 sessions of participation in the walking skill training program.~Walking skill training program: 12 individualized training sessions containing functional exercises like walking, stair climbing, balance training and with guidance from a physiotherapist."
1003279|NCT00808470|B3|Baseline|Total|Total of all reporting groups
1003280|NCT00808470|B2|Baseline|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
1003281|NCT00808470|B1|Baseline|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
1003282|NCT00808470|P2|Participant Flow|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
1003283|NCT00808470|P1|Participant Flow|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
1003284|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
1003285|NCT00808470|O1|Outcome|Nutrients|"beta-carotene, vitamins C and E, magnesium~beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
1003286|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
1003287|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
1003288|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
1003289|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
1003290|NCT00808470|O2|Outcome|Placebo for Nutrients|"Subjects in University of Florida music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
1003395|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
1003396|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
1003397|NCT00808249|E4|Reported Event|D-Placebo|Placebo
1003291|NCT00808470|O1|Outcome|Nutrients|"Dietary Supplement. Subjects in University of Florida music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
1003292|NCT00808470|E2|Reported Event|Placebo for Nutrients|"Subjects in UF music player study who are assigned to control (placebo) condition. Placebo tablets are consumed for 4 days.~Placebo Control: 6 mint-flavored tablets per day, containing inactive substances including mannitol, peppermint flavor, sucralose, color prep, iron oxide yellow synthetic, stearic acid (vegetable grade), and silicon dioxide colloidal."
1003293|NCT00808470|E1|Reported Event|Nutrients|"Dietary Supplement. Subjects in UF music player study who are assigned to active agent treatment group. Nutrient tablet treatments are consumed for 4 days.~Dietary supplement consisting of beta-carotene, vitamins C and E, magnesium: 6 mint-flavored tablets per day, taken once daily~total daily dose label claim: micronutrient combination of 500 mg vitamin C (magnesium ascorbate), 315 mg magnesium (magnesium citrate, magnesium ascorbate, magnesium stearate), 267 mg vitamin E (d-α-tocopherol acetate), and 18 mg beta carotene."
1003294|NCT00808444|B3|Baseline|Total|Total of all reporting groups
1003295|NCT00808444|B2|Baseline|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003296|NCT00808444|B1|Baseline|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003297|NCT00808444|P2|Participant Flow|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003298|NCT00808444|P1|Participant Flow|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003299|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003300|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003301|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003302|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003303|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003304|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003305|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003398|NCT00808249|E3|Reported Event|C-AZD7325 10 mg|AZD7325 10 mg QD
1003399|NCT00808249|E2|Reported Event|B-AZD7325 5 mg|AZD7325 5 mg BID
1003306|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003307|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003308|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003309|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003310|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003311|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003312|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003313|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003314|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003315|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003316|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003317|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003318|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003319|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003400|NCT00808249|E1|Reported Event|A-AZD7325 2 mg|AZD7325 2 mg BID
1003401|NCT00808236|B3|Baseline|Total|Total of all reporting groups
1003676|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
1003320|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003321|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003322|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003323|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003324|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003325|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003326|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003327|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003328|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003329|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003330|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003331|NCT00808444|O2|Outcome|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003332|NCT00808444|O1|Outcome|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003333|NCT00808444|E2|Reported Event|Synflorix Commercial Lot & Infanrix Group|Subjects received 3 doses of the commercial lot of Synflorix TM (GSK1024850A) intramuscularly in the lright thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 or 5 months of age in Malaysia or 2 and 5 months in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003402|NCT00808236|B2|Baseline|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003677|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
1003334|NCT00808444|E1|Reported Event|Synflorix Clinical Lot & Infanrix Group|Subjects received 3 doses of the clinical lot of Synflorix TM (GSK1024850A) intramuscularly in the right thigh at 2-3-5 months of age (= study month 0, 1, 3) co-administered with a DTPa-combined vaccine (Infanrix hexa TM (at 2, 3 and 5 months of age in Malaysia or 2 and 5 months of age in Singapore) or Infanrix-IPV/Hib TM (at 3 months of age in Singapore)) intramuscularly in the left thigh and Rotarix TM orally at 2-3 months of age (= study month 0, 1).
1003335|NCT00808405|B3|Baseline|Total|Total of all reporting groups
1003336|NCT00808405|B2|Baseline|Placebo|Matching placebo tablet
1003337|NCT00808405|B1|Baseline|Acyclovir|Acyclovir 400 mg orally three times daily
1003338|NCT00808405|P2|Participant Flow|Placebo|Matching placebo tablet
1003339|NCT00808405|P1|Participant Flow|Acyclovir|Acyclovir 400 mg orally three times daily
1003340|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
1003341|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
1003342|NCT00808405|O2|Outcome|Placebo|Matching placebo tablet
1003343|NCT00808405|O1|Outcome|Acyclovir|Acyclovir 400 mg orally three times daily
1003344|NCT00808405|E2|Reported Event|Placebo|Matching placebo tablet
1003345|NCT00808405|E1|Reported Event|Acyclovir|Acyclovir 400 mg orally three times daily
1003346|NCT00808340|B1|Baseline|Overall|
1003347|NCT00808340|P6|Participant Flow|Balafilcon A/Senofilcon A Prod/Senofilcon A Test|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A producton worn second, senofilcon A test worn third.
1003348|NCT00808340|P5|Participant Flow|Balafilcon A/Senofilcon A Test/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: balafilcon A worn first, senofilcon A test worn second, and senofilcon A production worn third.
1003349|NCT00808340|P4|Participant Flow|Senofilcon A Prod/ Balifilcon A/ Senofilcon A Test|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, balafilcon A worn second, and senofilcon A test worn third.
1003350|NCT00808340|P3|Participant Flow|Senofilcon A Prod/Senofilcon A Test/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A prod worn first, senofilcon A test worn second, and balafilcon A worn third.
1003351|NCT00808340|P2|Participant Flow|Senofilcon A Test/Balafilcon A/Senofilcon A Prod|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, balafilcon A worn second, and senofilcon A production worn third.
1003352|NCT00808340|P1|Participant Flow|Senofilcon A Test/Senofilcon A Prod/Balafilcon A|Subjects wear 3 multifocal contact lenses: senofilcon A test worn first, senofilcon A production worn second, and balafilcon A worn third.
1003353|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
1003354|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
1003355|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
1003356|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
1003357|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
1003358|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
1003359|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
1003360|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
1003361|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
1003362|NCT00808340|O3|Outcome|Balafilcon A|balafilcon A represents subjects that wore this lens in either the first, second, or third period.
1003363|NCT00808340|O2|Outcome|Senofilcon A Prod|senofilcon A prod represents subjects that wore this lens in either the first, second, or third period.
1003364|NCT00808340|O1|Outcome|Senofilcon A Test|senofilcon A test represents subjects that wore this lens in either the first, second, or third period.
1003365|NCT00808340|E3|Reported Event|Balafilcon A|
1003366|NCT00808340|E2|Reported Event|Senofilcon A Prod|
1003367|NCT00808340|E1|Reported Event|Senofilcon A Test|
1003368|NCT00808249|B5|Baseline|Total|Total of all reporting groups
1003369|NCT00808249|B4|Baseline|D-Placebo|Placebo
1003370|NCT00808249|B3|Baseline|C-AZD7325 10 mg|AZD7325 10 mg QD
1003371|NCT00808249|B2|Baseline|B-AZD7325 5 mg|AZD7325 5 mg BID
1003372|NCT00808249|B1|Baseline|A-AZD7325 2 mg|AZD7325 2 mg BID
1003373|NCT00808249|P4|Participant Flow|D-Placebo|Placebo
1003374|NCT00808249|P3|Participant Flow|C-AZD7325 10 mg|AZD7325 10 mg QD
1003375|NCT00808249|P2|Participant Flow|B-AZD7325 5 mg|AZD7325 5 mg BID
1003376|NCT00808249|P1|Participant Flow|A-AZD7325 2 mg|AZD7325 2 mg BID
1003377|NCT00808249|O4|Outcome|D-Placebo|Placebo
1003378|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
1003379|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
1003380|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
1003381|NCT00808249|O4|Outcome|D-Placebo|Placebo
1003382|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
1003383|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
1003384|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
1003385|NCT00808249|O4|Outcome|D-Placebo|Placebo
1003386|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
1003387|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
1003388|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
1003389|NCT00808249|O4|Outcome|D-Placebo|Placebo
1003390|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
1003391|NCT00808249|O2|Outcome|B-AZD7325 5 mg|AZD7325 5 mg BID
1003392|NCT00808249|O1|Outcome|A-AZD7325 2 mg|AZD7325 2 mg BID
1003393|NCT00808249|O4|Outcome|D-Placebo|Placebo
1003394|NCT00808249|O3|Outcome|C-AZD7325 10 mg|AZD7325 10 mg QD
1003403|NCT00808236|B1|Baseline|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003404|NCT00808236|P2|Participant Flow|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003405|NCT00808236|P1|Participant Flow|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003406|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003407|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003408|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003409|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003410|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003411|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003412|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003413|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003414|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003415|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003416|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003417|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003418|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003419|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003420|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003421|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003422|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003423|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003424|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003425|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003426|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003427|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003428|NCT00808236|O2|Outcome|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003429|NCT00808236|O1|Outcome|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003430|NCT00808236|E2|Reported Event|Control|Advanced cardiac life support (ACLS), only. ACLS procedures were performed in accordance with the European Resuscitation Council 2006 Guidelines.
1003431|NCT00808236|E1|Reported Event|RhinoChill|Intra-arrest cooling with the RhinoChill during advanced cardiac life support
1003432|NCT00808132|B6|Baseline|Total|Total of all reporting groups
1003433|NCT00808132|B5|Baseline|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003434|NCT00808132|B4|Baseline|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003435|NCT00808132|B3|Baseline|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003436|NCT00808132|B2|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003437|NCT00808132|B1|Baseline|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003438|NCT00808132|P5|Participant Flow|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003439|NCT00808132|P4|Participant Flow|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003440|NCT00808132|P3|Participant Flow|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003441|NCT00808132|P2|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003442|NCT00808132|P1|Participant Flow|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003443|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003444|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003445|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003446|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003447|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003448|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003449|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003450|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003451|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003452|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003453|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003454|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003455|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003456|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003457|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003458|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003459|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003460|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003461|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003462|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003463|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003464|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003465|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003466|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003467|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003468|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003469|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003470|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003471|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003472|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1020844|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1003473|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003474|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003475|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003476|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003477|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003478|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003479|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003480|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003481|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003482|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003483|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003484|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003485|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003486|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003487|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003488|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003489|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003490|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003491|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003492|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003493|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003494|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003495|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003496|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003497|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003498|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003499|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003500|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003501|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003502|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1020845|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1003503|NCT00808132|O5|Outcome|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003504|NCT00808132|O4|Outcome|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003505|NCT00808132|O3|Outcome|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003506|NCT00808132|O2|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003507|NCT00808132|O1|Outcome|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003508|NCT00808132|E5|Reported Event|Placebo|Placebo capsule matched to bazedoxifene/conjugated estrogen or bazedoxifene alone or conjugated estrogen/medroxyprogesterone acetate tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003509|NCT00808132|E4|Reported Event|Conjugated Estrogens 0.45mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogens 0.45 mg, medroxyprogesterone acetate 1.5 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003510|NCT00808132|E3|Reported Event|Bazedoxifene 20 mg|Bazedoxifene 20 mg tablet-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003511|NCT00808132|E2|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.625 mg|Bazedoxifene 20 mg, conjugated estrogens 0.625 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003512|NCT00808132|E1|Reported Event|Bazedoxifene 20 mg / Conjugated Estrogens 0.45 mg|Bazedoxifene 20 milligram (mg), conjugated estrogens 0.45 mg tablets-in-capsule orally once daily at approximately the same time each day continuously for 1 year.
1003513|NCT00808080|B1|Baseline|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)"
1003514|NCT00808080|P1|Participant Flow|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
1003515|NCT00808080|O1|Outcome|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
1003516|NCT00808080|E1|Reported Event|Biologic|"AML_CTL cells~AMLCTL: Ex-vivo expanded cytotoxic autologous AML-reactive T cells (CTL)~6 patients were enrolled, however none of the 6 patients became eligible to receive the AML CTL Infusion"
1003517|NCT00808067|B3|Baseline|Total|Total of all reporting groups
1003518|NCT00808067|B2|Baseline|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003519|NCT00808067|B1|Baseline|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003520|NCT00808067|P2|Participant Flow|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003521|NCT00808067|P1|Participant Flow|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003522|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003523|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003524|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003525|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003526|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003527|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003528|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003529|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003530|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003531|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003532|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003533|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003534|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003535|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003536|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003537|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003538|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003539|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003540|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003541|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003542|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003543|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003544|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003545|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003546|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003547|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003548|NCT00808067|O2|Outcome|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003549|NCT00808067|O1|Outcome|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003550|NCT00808067|E2|Reported Event|Dabigatran 150 mg|Dabigatran etexilate 150 mg twice daily
1003551|NCT00808067|E1|Reported Event|Dabigatran 110 mg|Dabigatran etexilate 110 mg twice daily
1003552|NCT00808028|B5|Baseline|Total|Total of all reporting groups
1003553|NCT00808028|B4|Baseline|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003554|NCT00808028|B3|Baseline|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003556|NCT00808028|B1|Baseline|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003557|NCT00808028|P4|Participant Flow|rLP2086 200 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003558|NCT00808028|P3|Participant Flow|rLP2086 120 mcg|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003559|NCT00808028|P2|Participant Flow|rLP2086 60 Microgram (mcg)|Given on a 0, 2-, 6-month schedule in Stage 1
1003560|NCT00808028|P1|Participant Flow|Control|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003561|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003562|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003563|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003564|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003565|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003566|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003567|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003568|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003569|NCT00808028|O3|Outcome|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
1003570|NCT00808028|O2|Outcome|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
1003571|NCT00808028|O1|Outcome|Control- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 48 months in Stage 2.
1003572|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003573|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003574|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003575|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003576|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003577|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003578|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003579|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003580|NCT00808028|O4|Outcome|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003581|NCT00808028|O3|Outcome|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003582|NCT00808028|O2|Outcome|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003583|NCT00808028|O1|Outcome|Control-Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1 and follow-up to 48 months in Stage 2.
1003584|NCT00808028|E11|Reported Event|rLP2086 200 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
1003585|NCT00808028|E10|Reported Event|rLP2086 120 mcg- Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
1003586|NCT00808028|E9|Reported Event|Control-Stage 2|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1 and further up to 48 months in Stage 2
1003587|NCT00808028|E8|Reported Event|rLP2086 200 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
1003588|NCT00808028|E7|Reported Event|rLP2086 120 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
1003589|NCT00808028|E6|Reported Event|rLP2086 60 mcg- Stage 1 Follow up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
1003590|NCT00808028|E5|Reported Event|Control-Stage 1 Follow-up|Given on a 0, 2-, 6-month schedule in Stage 1, were then followed up to 6 months in Stage 1
1003591|NCT00808028|E4|Reported Event|rLP2086 200 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003592|NCT00808028|E3|Reported Event|rLP2086 120 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003593|NCT00808028|E2|Reported Event|rLP2086 60 mcg- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003594|NCT00808028|E1|Reported Event|Control- Stage 1|Given on a 0, 2-, 6-month schedule in Stage 1
1003595|NCT00808015|B1|Baseline|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003596|NCT00808015|P1|Participant Flow|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003597|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003598|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003599|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003600|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003601|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003678|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
1003602|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003603|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003604|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003605|NCT00808015|O1|Outcome|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003606|NCT00808015|E1|Reported Event|Varenicline|Varenicline 0.5 mg once daily orally from Day 1 and titrated up to 1 mg dose twice daily (BID) from Day 8 till Week 12 or Last Observed Study Visit.
1003607|NCT00807989|B3|Baseline|Total|Total of all reporting groups
1003608|NCT00807989|B2|Baseline|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
1003609|NCT00807989|B1|Baseline|Carbamazepine|"Carbamazepine~Carbamazepine"
1003610|NCT00807989|P2|Participant Flow|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine 25mg/day for the first two weeks. At next two weeks, LTG 50 mg once a day"
1003611|NCT00807989|P1|Participant Flow|Carbamazepine|Carbamazepine 100mg/day for the first two weeks. At next two weeks, dose of Carbamazepine was increased to 200mg/day in two divided doses
1003612|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
1003613|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
1003614|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
1003615|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
1003616|NCT00807989|O2|Outcome|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
1003617|NCT00807989|O1|Outcome|Carbamazepine|"Carbamazepine~Carbamazepine"
1003618|NCT00807989|E2|Reported Event|Lamotrigine/Valproate|"Lamotrigine and Valproate combination therapy~Lamotrigine/Valproate"
1003619|NCT00807989|E1|Reported Event|Carbamazepine|"Carbamazepine~Carbamazepine"
1003620|NCT00807937|B5|Baseline|Total|Total of all reporting groups
1003621|NCT00807937|B4|Baseline|Placebo|Placebo
1003622|NCT00807937|B3|Baseline|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003623|NCT00807937|B2|Baseline|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003624|NCT00807937|B1|Baseline|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003625|NCT00807937|P4|Participant Flow|Placebo|Placebo
1003626|NCT00807937|P3|Participant Flow|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003627|NCT00807937|P2|Participant Flow|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003628|NCT00807937|P1|Participant Flow|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003629|NCT00807937|O4|Outcome|Placebo|Placebo
1003630|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003631|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003632|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003633|NCT00807937|O4|Outcome|Placebo|Placebo
1003634|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003635|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003636|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003637|NCT00807937|O4|Outcome|Placebo|Placebo
1003638|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003639|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003640|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003641|NCT00807937|O4|Outcome|Placebo|Placebo
1003642|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003643|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003644|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003645|NCT00807937|O4|Outcome|Placebo|Placebo
1003646|NCT00807937|O3|Outcome|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003647|NCT00807937|O2|Outcome|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003648|NCT00807937|O1|Outcome|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003649|NCT00807937|E4|Reported Event|Placebo|Placebo
1003650|NCT00807937|E3|Reported Event|Lorazepam|Lorazepam 2 mg twice daily (BID)
1003651|NCT00807937|E2|Reported Event|AZD7325 15 mg|AZD7325 15 mg twice daily (BID)
1003652|NCT00807937|E1|Reported Event|AZD7325 5 mg|AZD7325 5 mg twice daily (BID)
1003653|NCT00807885|B10|Baseline|Total|Total of all reporting groups
1003654|NCT00807885|B9|Baseline|SC Button With 27 ga X 9 mm Needle|
1003655|NCT00807885|B8|Baseline|Tape-secured 20 ga Polyurethane Catheter|
1003656|NCT00807885|B7|Baseline|Tegaderm-secured 20 ga Polyurethane Catheter|
1003657|NCT00807885|B6|Baseline|Tape-secured 20 ga Teflon Catheter|
1003658|NCT00807885|B5|Baseline|Tegaderm-secured 20 ga Teflon Catheter|
1003659|NCT00807885|B4|Baseline|Tape-secured 24 ga Polyurethane Catheter|
1003660|NCT00807885|B3|Baseline|Tegaderm-secured 24 ga Polyurethane Catheter|
1003661|NCT00807885|B2|Baseline|Tape-secured 24 ga Teflon Catheter|
1003662|NCT00807885|B1|Baseline|Tegaderm-secured 24 ga Teflon Catheter|
1003663|NCT00807885|P9|Participant Flow|SC Button With 27 ga X 9 mm Needle|
1003664|NCT00807885|P8|Participant Flow|Tape-secured 20 ga Polyurethane Catheter|
1003665|NCT00807885|P7|Participant Flow|Tegaderm-secured 20 ga Polyurethane Catheter|
1003666|NCT00807885|P6|Participant Flow|Tape-secured 20 ga Teflon Catheter|
1003667|NCT00807885|P5|Participant Flow|Tegaderm-secured 20 ga Teflon Catheter|
1003668|NCT00807885|P4|Participant Flow|Tape-secured 24 ga Polyurethane Catheter|
1003669|NCT00807885|P3|Participant Flow|Tegaderm-secured 24 ga Polyurethane Catheter|
1003670|NCT00807885|P2|Participant Flow|Tape-secured 24 ga Teflon Catheter|
1003671|NCT00807885|P1|Participant Flow|Tegaderm-secured 24 ga Teflon Catheter|
1003683|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
1003684|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
1003685|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
1003686|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
1003687|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
1003688|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
1003689|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
1003690|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
1003691|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
1003692|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
1003693|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
1003694|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
1003695|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
1003696|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
1003697|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
1003698|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
1003699|NCT00807885|O9|Outcome|SC Button With 27 ga X 9 mm Needle|
1003700|NCT00807885|O8|Outcome|Tape-secured 20 ga Polyurethane Catheter|
1003701|NCT00807885|O7|Outcome|Tegaderm-secured 20 ga Polyurethane Catheter|
1003702|NCT00807885|O6|Outcome|Tape-secured 20 ga Teflon Catheter|
1003703|NCT00807885|O5|Outcome|Tegaderm-secured 20 ga Teflon Catheter|
1003704|NCT00807885|O4|Outcome|Tape-secured 24 ga Polyurethane Catheter|
1003705|NCT00807885|O3|Outcome|Tegaderm-secured 24 ga Polyurethane Catheter|
1003706|NCT00807885|O2|Outcome|Tape-secured 24 ga Teflon Catheter|
1003707|NCT00807885|O1|Outcome|Tegaderm-secured 24 ga Teflon Catheter|
1003708|NCT00807885|E9|Reported Event|SC Button With 27 ga X 9 mm Needle|
1003709|NCT00807885|E8|Reported Event|Tape-secured 20 ga Polyurethane Catheter|
1003710|NCT00807885|E7|Reported Event|Tegaderm-secured 20 ga Polyurethane Catheter|
1003711|NCT00807885|E6|Reported Event|Tape-secured 20 ga Teflon Catheter|
1003712|NCT00807885|E5|Reported Event|Tegaderm-secured 20 ga Teflon Catheter|
1003713|NCT00807885|E4|Reported Event|Tape-secured 24 ga Polyurethane Catheter|
1003714|NCT00807885|E3|Reported Event|Tegaderm-secured 24 ga Polyurethane Catheter|
1003715|NCT00807885|E2|Reported Event|Tape-secured 24 ga Teflon Catheter|
1003716|NCT00807885|E1|Reported Event|Tegaderm-secured 24 ga Teflon Catheter|
1003717|NCT00807846|B3|Baseline|Total|Total of all reporting groups
1003718|NCT00807846|B2|Baseline|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003719|NCT00807846|B1|Baseline|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003720|NCT00807846|P2|Participant Flow|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003721|NCT00807846|P1|Participant Flow|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003722|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003723|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003724|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003725|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003726|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003727|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003728|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003729|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003730|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003731|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003732|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003733|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003734|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003735|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003736|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003737|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003738|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003739|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003740|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003741|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003742|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003743|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003744|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003745|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003746|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003747|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003748|NCT00807846|O2|Outcome|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003749|NCT00807846|O1|Outcome|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003750|NCT00807846|E2|Reported Event|Naproxen|Participants received naproxen suspension 7.5 mg/kg BID (maximum dose of 500 mg BID) for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003751|NCT00807846|E1|Reported Event|Celecoxib|Participants received celecoxib capsules 50 mg twice daily (BID) or 100 mg BID for 6 weeks. The volume/dose of the study medications was determined by the subject’s weight at Baseline visit
1003752|NCT00807573|B1|Baseline|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced NSCLC. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1, 15 and 19.
1003753|NCT00807573|P1|Participant Flow|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
1003754|NCT00807573|O1|Outcome|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
1003755|NCT00807573|E1|Reported Event|Paclitaxel, Bevacizumab & Pemetrexed|Paclitaxel, Bevacizumab and Pemetrexed in Untreated, Advanced Non-Small Cell Lung Cancer. During each 28-day cycle, paclitaxel, pemetrexed and bevacizumab will be given intravenously on days 1 and 15. Paclitaxel will be administered at 90mg/m^2 over 60 minutes on days 1 and 15. Pemetrexed 500mg/m^2 will be administered over 10 minutes on days 1 and 15. Bevacizumab will be given at 10mg/kg over 20 minutes on days 1 and 15, and 19.
1003756|NCT00807560|B3|Baseline|Total|Total of all reporting groups
1003757|NCT00807560|B2|Baseline|NEC-control|Nutritional Educational Control Condition
1003758|NCT00807560|B1|Baseline|FBT-PO|Family Based Therapy for Pediatric Overweight
1003759|NCT00807560|P2|Participant Flow|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
1003760|NCT00807560|P1|Participant Flow|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
1003761|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003762|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003763|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003764|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003765|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003766|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003767|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003768|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003769|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003770|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003771|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003772|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003773|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003774|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003775|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003776|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003777|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003778|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003779|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003780|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003781|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003782|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003783|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003784|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003785|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003786|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003787|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003788|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003789|NCT00807560|O2|Outcome|NEC-control|Nutritional Educational Control Condition
1003790|NCT00807560|O1|Outcome|FBT-PO|Family Based Therapy for Pediatric Overweight
1003791|NCT00807560|E2|Reported Event|NEC- Control|"Nutritional Educational Control Condition (NEC).~NEC : Families assigned to NEC will receive a minimal nutrition and physical activity education curriculum across 16 sessions over 24 weeks."
1003792|NCT00807560|E1|Reported Event|FBT-PO|"Family Based Therapy for Pediatric Overweight.~FBT-PO : The goal of FBT-PO is to resolve the eating disorder and return the patient to healthy psychosocial and physiological developmental trajectories through active family involvement across three treatment phases."
1003793|NCT00807456|B1|Baseline|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
1003794|NCT00807456|P1|Participant Flow|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
1003795|NCT00807456|O1|Outcome|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
1003796|NCT00807456|E1|Reported Event|ASTRA TECH Implant System, OsseoSpeed™ Profile|ASTRA TECH Implant System, OsseoSpeed™: ASTRA TECH Implant System, OsseoSpeed™ Profile implants: Ø4.5, 5.0, 5.0S mm in lengths of 9, 11, 13, 15mm.
1003797|NCT00807365|B1|Baseline|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
1003798|NCT00807365|P1|Participant Flow|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 Post Meridian (PM), 1:00 Ante Meridian (AM), 3:00 AM, & 5:00 AM for 6 months."
1003799|NCT00807365|O1|Outcome|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
1003800|NCT00807365|E1|Reported Event|GHRH|"Growth Hormone-Releasing Hormone~GHRH: GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, & 5:00 AM for 6 months."
1003801|NCT00807248|B5|Baseline|Total|Total of all reporting groups
1003802|NCT00807248|B4|Baseline|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003803|NCT00807248|B3|Baseline|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003804|NCT00807248|B2|Baseline|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003805|NCT00807248|B1|Baseline|Placebo (Orally, Once Daily)|
1003806|NCT00807248|P4|Participant Flow|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003807|NCT00807248|P3|Participant Flow|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003808|NCT00807248|P2|Participant Flow|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003809|NCT00807248|P1|Participant Flow|Placebo (Orally, Once Daily)|
1003810|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003811|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003812|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003813|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003814|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003815|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003816|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003817|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003818|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003819|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003820|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003821|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003822|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003823|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003824|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003825|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003826|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003827|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003828|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003829|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003830|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003831|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003832|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003833|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003834|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003835|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003836|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003837|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003838|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003839|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003840|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003841|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003842|NCT00807248|O4|Outcome|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003843|NCT00807248|O3|Outcome|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003844|NCT00807248|O2|Outcome|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003845|NCT00807248|O1|Outcome|Placebo (Orally, Once Daily)|
1003846|NCT00807248|E4|Reported Event|Escitalopram 20 mg and Gaboxadol 10 mg (Orally, Once Daily)|
1003847|NCT00807248|E3|Reported Event|Escitalopram 20 mg and Gaboxadol 5 mg (Orally, Once Daily)|
1003848|NCT00807248|E2|Reported Event|Escitalopram 20 mg and Placebo (Orally, Once Daily)|
1003849|NCT00807248|E1|Reported Event|Placebo (Orally, Once Daily)|
1003850|NCT00807235|B3|Baseline|Total|Total of all reporting groups
1003851|NCT00807235|B2|Baseline|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003852|NCT00807235|B1|Baseline|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003853|NCT00807235|P2|Participant Flow|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003854|NCT00807235|P1|Participant Flow|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003855|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003856|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003857|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003858|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003859|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003860|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003861|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003862|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003863|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003864|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003865|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003866|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003867|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003868|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003869|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003870|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003871|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003872|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003873|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003874|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003875|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003876|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1005093|NCT00804687|B1|Baseline|Entire Study Population|Includes all participants randomized in the study.
1003877|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003878|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003879|NCT00807235|O2|Outcome|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003880|NCT00807235|O1|Outcome|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003881|NCT00807235|E2|Reported Event|Lucinactant - 1 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 1 hour
1003882|NCT00807235|E1|Reported Event|Lucinactant - 3 Hour Interval|Aerosolized Lucinactant via nasal continuous positive airway pressure (nCPAP) w/ Retreatment after 3 hours
1003883|NCT00807209|B4|Baseline|Total|Total of all reporting groups
1003884|NCT00807209|B3|Baseline|Low Dose SKY0402|
1003885|NCT00807209|B2|Baseline|Standard of Care|
1003886|NCT00807209|B1|Baseline|High Dose SKY0402|
1003887|NCT00807209|P3|Participant Flow|Low Dose SKY0402|
1003888|NCT00807209|P2|Participant Flow|Standard of Care|
1003889|NCT00807209|P1|Participant Flow|High Dose SKY0402|
1003890|NCT00807209|O3|Outcome|Low Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
1003891|NCT00807209|O2|Outcome|Standard of Care|Bupivacaine HCl solution (1.25 mg/mL) and epinephrine (5 mcg/mL) administered via an epidural catheter at a concentration of 0.125% (1.25 mg/mL) at a rate of 8 cc per hour
1003892|NCT00807209|O1|Outcome|High Dose SKY0402|Single dose of study drug divided equally into three 4 mL doses and delivered to each of three nerve segments following posterolateral thoracotomy
1003893|NCT00807209|E3|Reported Event|Low Dose SKY0402|
1003894|NCT00807209|E2|Reported Event|Standard of Care|
1003895|NCT00807209|E1|Reported Event|High Dose SKY0402|
1003896|NCT00807092|B3|Baseline|Total|Total of all reporting groups
1003897|NCT00807092|B2|Baseline|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003898|NCT00807092|B1|Baseline|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003899|NCT00807092|P2|Participant Flow|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003900|NCT00807092|P1|Participant Flow|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003901|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003902|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003903|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003904|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003905|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003951|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003952|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003906|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003907|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003908|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003909|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003910|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003911|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003912|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003913|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003914|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003915|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003916|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003917|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003918|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003919|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003920|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1005130|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1003921|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003922|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003923|NCT00807092|O2|Outcome|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003924|NCT00807092|O1|Outcome|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003925|NCT00807092|E2|Reported Event|BHI 30|BHI 30 (biphasic human insulin 30) administered subcutaneously (under the skin) twice daily (30 minutes before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BHI 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003926|NCT00807092|E1|Reported Event|BIAsp 30|BIAsp 30 (biphasic insulin aspart 30) administered subcutaneously (under the skin) twice daily (before breakfast and dinner) + metformin. Initial total daily dose of 0.3 U or IU/kg body weight followed by individual dose adjustment for BIAsp 30 was performed over the first 4 weeks (titration period) to achieve the pre-meal blood glucose target of 4.4-6.1 mmol/l. The achieved dose was maintained for the last 2 weeks of treatment unless hypoglycaemia occurred.
1003927|NCT00807014|B3|Baseline|Total|Total of all reporting groups
1003928|NCT00807014|B2|Baseline|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003929|NCT00807014|B1|Baseline|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003930|NCT00807014|P2|Participant Flow|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003931|NCT00807014|P1|Participant Flow|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003932|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003933|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003934|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003935|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003936|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003937|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003938|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003939|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003940|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003941|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003942|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003943|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003944|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003945|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003946|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003947|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003948|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003949|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003950|NCT00807014|O2|Outcome|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1005131|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1003953|NCT00807014|O1|Outcome|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003954|NCT00807014|E2|Reported Event|Differin Gel|Differin gel (containing 0.1% adapalene) applied topically to facial acne once nightly for 12 weeks
1003955|NCT00807014|E1|Reported Event|Duac Gel|Duac gel (combination of clindamycin phosphate [equivalent to 1% clindamycin] and 5% benzoyl peroxide) applied topically to facial acne once nightly for 12 weeks
1003956|NCT00807001|B6|Baseline|Total|Total of all reporting groups
1003957|NCT00807001|B5|Baseline|IDX184 100 mg|
1003958|NCT00807001|B4|Baseline|IDX184 75 mg|
1003959|NCT00807001|B3|Baseline|IDX184 50 mg|
1003960|NCT00807001|B2|Baseline|IDX184 25 mg|
1003961|NCT00807001|B1|Baseline|Placebo|
1003962|NCT00807001|P5|Participant Flow|IDX184 100 mg|
1003963|NCT00807001|P4|Participant Flow|IDX184 75 mg|
1003964|NCT00807001|P3|Participant Flow|IDX184 50 mg|
1003965|NCT00807001|P2|Participant Flow|IDX184 25 mg|
1003966|NCT00807001|P1|Participant Flow|Placebo|
1003967|NCT00807001|O5|Outcome|IDX184 100 mg|
1003968|NCT00807001|O4|Outcome|IDX184 75 mg|
1003969|NCT00807001|O3|Outcome|IDX184 50 mg|
1003970|NCT00807001|O2|Outcome|IDX184 25 mg|
1003971|NCT00807001|O1|Outcome|Placebo|
1003972|NCT00807001|O5|Outcome|IDX184 100 mg|
1003973|NCT00807001|O4|Outcome|IDX184 75 mg|
1003974|NCT00807001|O3|Outcome|IDX184 50 mg|
1003975|NCT00807001|O2|Outcome|IDX184 25 mg|
1003976|NCT00807001|O1|Outcome|Placebo|
1003977|NCT00807001|E5|Reported Event|IDX184 100 mg|
1003978|NCT00807001|E4|Reported Event|IDX184 75 mg|
1003979|NCT00807001|E3|Reported Event|IDX184 50 mg|
1003980|NCT00807001|E2|Reported Event|IDX184 25 mg|
1003981|NCT00807001|E1|Reported Event|Placebo|
1003982|NCT00806819|B3|Baseline|Total|Total of all reporting groups
1003983|NCT00806819|B2|Baseline|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003984|NCT00806819|B1|Baseline|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003985|NCT00806819|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003986|NCT00806819|P1|Participant Flow|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003987|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003988|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003989|NCT00806819|O2|Outcome|Nintedanib 150 mg Bid Plus Pemetrexed|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion.
1003990|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003991|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003992|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1005132|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1003993|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003994|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003995|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003996|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003997|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003998|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1003999|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004000|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004001|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004002|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004003|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004004|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004005|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004006|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004007|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004008|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004009|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004010|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004011|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004012|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004013|NCT00806819|O2|Outcome|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004014|NCT00806819|O1|Outcome|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004015|NCT00806819|E2|Reported Event|Placebo Plus Pemetrexed|Placebo soft gelatin capsule matching that of nintedanib 2 times daily on day 2 to 21 of each 21-day treatment course administered orally plus pemetrexed 500 mg/m2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004016|NCT00806819|E1|Reported Event|Nintedanib Plus Pemetrexed|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule on day2 to 21 of each 21-day treatment course plus pemetrexed 500 mg/m2 on Day1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nitedanib could be redused to 150 mg twice daily (b.i.d.) or 100 mg b.i.d. and two dose reductions for pemetrexed were allowed (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction.
1004017|NCT00806624|B4|Baseline|Total|Total of all reporting groups
1004018|NCT00806624|B3|Baseline|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
1004019|NCT00806624|B2|Baseline|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004020|NCT00806624|B1|Baseline|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004021|NCT00806624|P3|Participant Flow|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
1004022|NCT00806624|P2|Participant Flow|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004023|NCT00806624|P1|Participant Flow|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004024|NCT00806624|O3|Outcome|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
1004025|NCT00806624|O2|Outcome|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004026|NCT00806624|O1|Outcome|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004027|NCT00806624|E3|Reported Event|Warfarin Potassium|Warfarin was administered once daily at the dose to achieve an INR between 2.0 and 3.0 for 3 months.
1004028|NCT00806624|E2|Reported Event|DU-176b 60 mg|60 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004029|NCT00806624|E1|Reported Event|DU176b 30mg|30 mg of DU-176b was administered once daily in the morning in principle for 3 months.
1004030|NCT00806598|B1|Baseline|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
1004058|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004605|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004031|NCT00806598|P1|Participant Flow|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
1004032|NCT00806598|O1|Outcome|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + Granulocyte Colony stimulating factor (G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
1004033|NCT00806598|E1|Reported Event|Thymoglobulin + Cyclosporin|"Combination of Thymoglobulin + Methylprednisone + Cyclosporin + G-CSF~Cyclosporine : 5 mg/kg orally for 6 months; start after completing thymoglobulin.~G-CSF : G-CSF 5 microgram/kg subcutaneously daily up to 3 months, start after thymoglobulin.~Thymoglobulin : 3.5 or 2.5 mg/kg/day IV for 5 days~Aplastic anemia patients receive 3.5 mg/kg/day for 5 days~MDS patients <55 years receive 3.5 mg/kg/day for 5 days~MDS patients >55 years receive 2.5 mg/kg/day for 5 days~Methylprednisolone : 1 mg/kg/day IV for 5 days, given before each dose of thymoglobulin."
1004034|NCT00806585|B6|Baseline|Total|Total of all reporting groups
1004035|NCT00806585|B5|Baseline|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004036|NCT00806585|B4|Baseline|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004037|NCT00806585|B3|Baseline|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004038|NCT00806585|B2|Baseline|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004039|NCT00806585|B1|Baseline|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004040|NCT00806585|P5|Participant Flow|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004041|NCT00806585|P4|Participant Flow|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004042|NCT00806585|P3|Participant Flow|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004043|NCT00806585|P2|Participant Flow|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004044|NCT00806585|P1|Participant Flow|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004045|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004046|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004047|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004048|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004049|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004050|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004051|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004052|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004053|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004054|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004055|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004056|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004057|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1005133|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004059|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004060|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004061|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004062|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004063|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004064|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004065|NCT00806585|O5|Outcome|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004066|NCT00806585|O4|Outcome|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004067|NCT00806585|O3|Outcome|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004068|NCT00806585|O2|Outcome|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004069|NCT00806585|O1|Outcome|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004070|NCT00806585|E5|Reported Event|Placebo|One placebo tablet daily, orally, for 24 weeks (Phase A). Participant will continue to receive placebo, once daily for 52 weeks (Phase B)
1004071|NCT00806585|E4|Reported Event|HCTZ 12.5 mg → MK-0736 8.0 mg|one 12.5 mg hydrochlorothiazide (HCTZ) tablet daily, orally, for 12 weeks. Participant then switched to MK-0736 8.0 mg for 12 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004072|NCT00806585|E3|Reported Event|MK-0736 8.0 mg|One MK-0736 8.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will continue to receive MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004073|NCT00806585|E2|Reported Event|MK-0736 2.0 mg|One MK-0736 2.0 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for 52 weeks (Phase B).
1004074|NCT00806585|E1|Reported Event|MK-0736 0.5 mg|One MK-0736 0.5 mg tablet, orally, once daily for 24 weeks (Phase A). Participant will then be switched to MK-0736 8.0 mg, once daily for an additional 52 weeks (Phase B).
1004075|NCT00806546|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1004076|NCT00806546|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1004077|NCT00806546|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1004078|NCT00806546|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with mild to severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1004079|NCT00806494|B1|Baseline|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004080|NCT00806494|P1|Participant Flow|Fesoterodine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004081|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004082|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004083|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004084|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004085|NCT00806494|O1|Outcome|Fesoteridine|Fesoterodine 4mg tablet orally once daily (QD) for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004086|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004087|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004088|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004089|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004090|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004091|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004092|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004093|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004094|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004095|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004096|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004097|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004098|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004099|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004100|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004101|NCT00806494|O1|Outcome|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004102|NCT00806494|E1|Reported Event|Fesoterodine|Fesoterodine 4mg tablet orally QD for 4 weeks followed by either escalation to 8mg tablet QD or continuation of 4mg tablet QD for the remaining 8 weeks of the study treatment phase, as required.
1004103|NCT00806416|B3|Baseline|Total|Total of all reporting groups
1004104|NCT00806416|B2|Baseline|Part II|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
1004105|NCT00806416|B1|Baseline|Part I|70 mg alendronate/2800-IU vitamin D3 combination tablet; 70 mg alendronate tablet
1004106|NCT00806416|P4|Participant Flow|Vitamin D Then Alendronate/Vitamin D Combination|2800-IU vitamin D3 tablet; 70 mg alendronate/2800-IU vitamin D3 comination tablet
1004107|NCT00806416|P3|Participant Flow|Alendronate/Vitamin D Combination Then Vitamin D|70 mg alendronate/2800-IU vitamind D3 combination tablet; 2800-IU vitamin D3 tablet
1004108|NCT00806416|P2|Participant Flow|Alendronate Then Alendronate/Vitamin D Combination|70 mg alendronate tablet; 70 mg alendronate/2800-IU vitamind D3 comination tablet
1004109|NCT00806416|P1|Participant Flow|Alendronate/Vitamin D Combination Then Alendronate|70 mg alendronate/2800-IU (international unit) vitamin D3 (cholecalciferol) combination tablet; 70 mg alendronate tablet
1004110|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
1004111|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
1004112|NCT00806416|O2|Outcome|Vitamin D|2800-IU vitamin D3 tablet
1004113|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
1004114|NCT00806416|O2|Outcome|Alendronate|70 mg alendronate tablet
1004115|NCT00806416|O1|Outcome|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
1004116|NCT00806416|E3|Reported Event|Vitamin D|2800-IU vitamin D3 tablet
1004117|NCT00806416|E2|Reported Event|Alendronate|70 mg alendronate tablet
1004118|NCT00806416|E1|Reported Event|Alendronate/Vitamin D Combination|70 mg alendronate/2800-IU vitamin D3 combination tablet
1004119|NCT00806403|B3|Baseline|Total|Total of all reporting groups
1004120|NCT00806403|B2|Baseline|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
1004121|NCT00806403|B1|Baseline|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
1004122|NCT00806403|P2|Participant Flow|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
1004123|NCT00806403|P1|Participant Flow|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
1004124|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
1004125|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
1004126|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
1004127|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
1004128|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
1004129|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
1004130|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
1004131|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
1004132|NCT00806403|O2|Outcome|Invasive|500 mg aspirin p o and enoxaparin 0,75 mg/kg bodyweight plus a bolus of abciximab o,25 mg/kg bodyweight i v at first contact (prehospitally or in hospital). Therafter immediate transport to a catheterization lab for PCI. A loading dose of Clopidogrel 300 mg was given to stented patients immediately after PCI and continued for 3 months. Abciximab was given as an infusion of 10 mikrog/min for 12 h.
1004133|NCT00806403|O1|Outcome|Thrombolysis|Reteplase 10U+10U i v plus enoxaparin 30 mg i v at first contact (prehospitally or in hospital) followed by enxaparin 1 mg/kg bodyweight s c every 12 h during hospital stay.
1004134|NCT00806390|B3|Baseline|Total|Total of all reporting groups
1004135|NCT00806390|B2|Baseline|Control|Not receiving metoprolol
1004136|NCT00806390|B1|Baseline|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
1004137|NCT00806390|P2|Participant Flow|Control|Not receiving metoprolol
1004138|NCT00806390|P1|Participant Flow|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
1004139|NCT00806390|O2|Outcome|Control|Not receiving metoprolol
1004140|NCT00806390|O1|Outcome|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
1004141|NCT00806390|E2|Reported Event|Control|Not receiving metoprolol
1004142|NCT00806390|E1|Reported Event|Metoprolol|"Receiving metoprolol~Metoprolol: Metroprolol tartrate titrated up"
1004143|NCT00806351|B3|Baseline|Total|Total of all reporting groups
1004144|NCT00806351|B2|Baseline|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004145|NCT00806351|B1|Baseline|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004146|NCT00806351|P2|Participant Flow|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004147|NCT00806351|P1|Participant Flow|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004148|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004149|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004150|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004151|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004152|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004153|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004154|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004155|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004156|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004205|NCT00806234|P2|Participant Flow|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
1004606|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
1004157|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004158|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004159|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004160|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004161|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004162|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004163|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004164|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004165|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004206|NCT00806234|P1|Participant Flow|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
1004607|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004166|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004167|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004168|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004169|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004170|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004171|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004172|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004173|NCT00806351|O2|Outcome|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant's weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004174|NCT00806351|O1|Outcome|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004207|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
1004258|NCT00804908|P3|Participant Flow|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004175|NCT00806351|E2|Reported Event|Caspofungin|Participants received caspofungin (35, 50, or 70 mg depending on participant’s weight, baseline liver function, or receipt of an interacting drug) followed by matched placebo-anidulafungin QD or participants received matched placebo-anidulafungin followed by active caspofungin (35, 50, or 70 mg) QD. Caspofungin loading dose on Day 1 was 70 mg. Study treatments given either entirely as IV therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004176|NCT00806351|E1|Reported Event|Anidulafungin|Participants received anidulafungin (100 milligrams [mg]) followed by matched placebo-caspofungin once daily (QD) or participants received matched placebo-caspofungin followed by active anidulafungin (100 mg) QD. Anidulafungin loading dose on Day 1 was 200 mg. Study treatments given either entirely as intravenous (IV) therapy or if protocol-specified criteria met, as sequential IV (at least 10 days) then oral antifungal therapy (14 days). Dosage of antifungal therapy (fluconazole or voriconazole tablets) determined by the Investigator. A maximum of 42 days of IV study treatment and a maximum of 14 days of oral study treatment allowed. Thus, participants may have received up to a maximum of 56 days of study therapy.
1004177|NCT00806260|B7|Baseline|Total|Total of all reporting groups
1004178|NCT00806260|B6|Baseline|Alcohol Placebo Only|Subject in this study arm only participated in period 1 and were given alcohol placebo.
1004179|NCT00806260|B5|Baseline|Alcohol Only|Subjects in this study arm only participated in period 1 and were given alcohol.
1004180|NCT00806260|B4|Baseline|Alcohol Placebo, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol placebo in period 1, VI-0521 in period 2 and VI-0521 placebo in period 3.
1004181|NCT00806260|B3|Baseline|Alcohol Placebo, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol placebo in period 1, VI-0521-placebo in period 2 and VI-0521 in period 3.
1004182|NCT00806260|B2|Baseline|Alcohol, VI-0521 Then VI-0521 Placebo|Participants in this study arm were given alcohol in period 1, VI-0521 in period 2 and VI-0521-placebo in period 3.
1004183|NCT00806260|B1|Baseline|Alcohol, VI-0521 Placebo Then VI-0521|Participants in this study arm were given alcohol in period 1, VI-0521 placebo in period 2 and VI-0521 in period 3.
1004184|NCT00806260|P6|Participant Flow|Alcohol-placebo Only|Alcohol-placebo was administered during period one after which the subject's participation ended.
1004185|NCT00806260|P5|Participant Flow|Alcohol Only|Alcohol was administered during period one after which the subject's participation ended.
1004186|NCT00806260|P4|Participant Flow|Alcohol-placebo, VI-0521 Then VI-0521-placebo|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
1004187|NCT00806260|P3|Participant Flow|Alcohol-placebo, VI-0521-placebo Then VI-0521|Alcohol-placebo was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
1004188|NCT00806260|P2|Participant Flow|Alcohol, VI-0521 Then VI-0521 Placebo|Alcohol was administered during period one followed by one week washout, VI-0521 titrated over four weeks during period two followed by one week washout, then VI-0521 placebo for four weeks during period three.
1004189|NCT00806260|P1|Participant Flow|Alcohol, VI-0521 Placebo Then VI-0521|Alcohol was administered during period one followed by one week washout, VI-0521 placebo for four weeks during period two followed by one week washout, then VI-0521 titrated over four weeks during period three.
1004190|NCT00806260|O4|Outcome|Period 3 VI-0521|phentermine/topiramate
1004191|NCT00806260|O3|Outcome|Period 3 VI-0521-placebo|placebo
1004192|NCT00806260|O2|Outcome|Period 2 VI-0521|phentermine/topiramate
1004193|NCT00806260|O1|Outcome|Period 2 VI-0521-placebo|Placebo
1004194|NCT00806260|O2|Outcome|Period 1 Alcohol|Alcohol
1004195|NCT00806260|O1|Outcome|Period 1 Alcohol-placebo|fruit juice
1004196|NCT00806260|E4|Reported Event|Period 2 and 3 Qnexa|The total number of subjects that were given VI-0521 was 41. 2 subjects were excluded from the analysis, one due to failing a drug/alcohol screen and the other due to pregnancy. Excluding these two subjects leaves 39 subjects in the analyzed ITT population.
1004197|NCT00806260|E3|Reported Event|Period 2 and 3 Placebo|Total number of subjects that were given VI-0521 placebo was 43. 1 subject was excluded from the analysis due to failing a drug/alcohol screen leaving 42 subjects in the ITT population.
1004198|NCT00806260|E2|Reported Event|Period 1 Alcohol|
1004199|NCT00806260|E1|Reported Event|Period 1 Placebo|
1004200|NCT00806234|B4|Baseline|Total|Total of all reporting groups
1004201|NCT00806234|B3|Baseline|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
1004202|NCT00806234|B2|Baseline|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
1004203|NCT00806234|B1|Baseline|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
1004204|NCT00806234|P3|Participant Flow|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
1004257|NCT00804908|B1|Baseline|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004208|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
1004209|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
1004210|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
1004211|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
1004212|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
1004213|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
1004214|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
1004215|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
1004216|NCT00806234|O3|Outcome|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
1004217|NCT00806234|O2|Outcome|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
1004218|NCT00806234|O1|Outcome|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
1004219|NCT00806234|E3|Reported Event|Metformin Treatment + Healthy Lifestyle Instruction|"Participants will add metformin to current antipsychotic medication treatment.~Metformin: Metformin treatment will be added to current SGA treatment, with dosing based on participant weight and increased according to a preset titration schedule unless side effects interfere."
1004220|NCT00806234|E2|Reported Event|Switch Treatment + Healthy Lifestyle Instruction|"Participants will undergo a staggered switch from current antipsychotic medication to aripiprazole or perphenazine.~Aripiprazole or Perphenazine: Baseline second generation antipsychotic (SGA) treatment will be gradually decreased and discontinued over 8 weeks while treatment with aripiprazole or perphenazine will be increased to effective levels."
1004221|NCT00806234|E1|Reported Event|Healthy Lifestyle Information|"Participants will continue on current antipsychotic medication.~Olanzapine, quetiapine, risperidone, ziprasidone, aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine: Current antipsychotic medication will be continued throughout the treatment period, with changes in dose only made as clinically indicated"
1004222|NCT00806195|B5|Baseline|Total|Total of all reporting groups
1004223|NCT00806195|B4|Baseline|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
1004224|NCT00806195|B3|Baseline|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
1004225|NCT00806195|B2|Baseline|Routine Vaccines (Non-Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
1004226|NCT00806195|B1|Baseline|MenACWY-CRM197 + Routine Vaccines (Non-Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
1004227|NCT00806195|P4|Participant Flow|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity, all AEs for 7 days, SAEs and medically attended AEs."
1004228|NCT00806195|P3|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
1004229|NCT00806195|P2|Participant Flow|Routine Vaccines (Non-detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided SAEs and medically attended AEs."
1004230|NCT00806195|P1|Participant Flow|MenACWY-CRM197 + Routine Vaccines (Non-detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR: 12 months.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Non-Detailed - subjects who only provided Serious Adverse Events (SAEs) and medically attended Adverse (AE)."
1004231|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
1004232|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - infants who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - infants who only provided SAEs and medically attended AEs."
1004233|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
1004234|NCT00806195|O1|Outcome|MenACWY-CRM 197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - subjects who provided reactogenicity and all AEs for 7 days, SAEs and medically attended AEs."
1004235|NCT00806195|O2|Outcome|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
1004236|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
1005134|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1004237|NCT00806195|O2|Outcome|Routine Vaccines (Detailed)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6 months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
1004238|NCT00806195|O1|Outcome|MenACWY-CRM197 + Routine Vaccines (Detailed)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~Detailed - infants who provided reactogenicity and all Adverse Events (AEs) for 7 days, Serious Adverse Events (SAEs) and medically attended AEs."
1004239|NCT00806195|E2|Reported Event|Routine Vaccines (All)|"Infants received one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, and Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
1004240|NCT00806195|E1|Reported Event|MenACWY-CRM197 + Routine Vaccines (All)|"Infants received one vaccination of MenACWY-CRM197 vaccine at 2, 4, 6 and 12 months of age and one vaccination of routine vaccines (according to the local vaccination schedule) - DTaP: 2, 4, 6, 15 months, IPV: 2, 4, 6, months, Hib: 2, 4, 6, 15 months, Pneumococcal conjugate: 2, 4, 6, 12 months, MMR, Varicella, Hepatitis A: 12 months. HBV and rotavirus vaccines should be administered according to ACIP guidelines during the first year of life.~Routine vaccines given to subjects in these arms will be consistent with the US ACIP recommended vaccines.~All (Detailed and Non-Detailed subjects): Detailed - subjects who provided Reactogenicity and all AEs for 7 days, SAEs and medically attended AEs; Non-Detailed - subjects who only provided SAEs and medically attended AEs."
1004241|NCT00806078|B3|Baseline|Total|Total of all reporting groups
1004242|NCT00806078|B2|Baseline|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
1004243|NCT00806078|B1|Baseline|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
1004244|NCT00806078|P2|Participant Flow|Quinine With Chocolate Pudding First|Participants were randomized to receive a single dose of Quinine 648 mg (2 x 324 mg capsules) opened and mixed in 120 mL chocolate pudding after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose. Following a 7 day wash out period, all participants were given Quinine 648 mg (2 x 324 mg) as intact capsules under similar conditions.
1004245|NCT00806078|P1|Participant Flow|Quinine Alone First|Participants were randomized to receive a single dose of quinine 648 mg (2 x 324 mg) as intact capsules after a fast of at least 10 hours. Blood was drawn at times sufficient to characterize quinine pharmacokinetics after this dose. Following a 7 day wash out period, all participants were given quinine 648 mg (2 x 324 mg) as capsules opened and their contents mixed in 120 mL chocolate pudding under similar conditions.
1004246|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
1004247|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
1004248|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
1004249|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
1004250|NCT00806078|O2|Outcome|Quinine With Chocolate Pudding|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
1004251|NCT00806078|O1|Outcome|Quinine Alone|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
1004252|NCT00806078|E2|Reported Event|Quinine With Chocolate Pudding First|After a fast of at least 10 hours participants received a single dose of quinine 648 mg (2 x 324 mg) capsules opened and mixed in 120 mL chocolate pudding. Blood was drawn at times sufficient to characterize the pharmacokinetics of quinine after this dose.
1004253|NCT00806078|E1|Reported Event|Quinine Alone First|After a fast of at least 10 hours, participants received a single dose of quinine 648 mg (2 x 324 mg) as intact capsules. Blood was drawn sufficient to characterize the pharmacokinetics of quinine after this dose.
1004254|NCT00804908|B4|Baseline|Total|Total of all reporting groups
1004255|NCT00804908|B3|Baseline|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004256|NCT00804908|B2|Baseline|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004259|NCT00804908|P2|Participant Flow|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004260|NCT00804908|P1|Participant Flow|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004261|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004262|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004263|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004264|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004265|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004266|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004267|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004268|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004269|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004270|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004271|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004272|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004273|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004274|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004275|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004276|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004277|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004278|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004279|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004280|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004281|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004282|NCT00804908|O3|Outcome|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004283|NCT00804908|O2|Outcome|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004284|NCT00804908|O1|Outcome|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004285|NCT00804908|E3|Reported Event|ABT-888 40 mg BID + TMZ QD|ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004286|NCT00804908|E2|Reported Event|ABT-888 20 mg BID + TMZ QD|ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004287|NCT00804908|E1|Reported Event|Placebo for ABT-888 BID + TMZ QD|Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
1004288|NCT00804843|B3|Baseline|Total|Total of all reporting groups
1004289|NCT00804843|B2|Baseline|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
1004290|NCT00804843|B1|Baseline|Statin 80 mg + Niacin ER|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin.
1004291|NCT00804843|P2|Participant Flow|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
1004608|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004292|NCT00804843|P1|Participant Flow|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
1004293|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
1004294|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
1004295|NCT00804843|O2|Outcome|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~receive 10 mg Atorvastatin."
1004296|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
1004297|NCT00804843|O2|Outcome|Statin 10 mg|Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will receive 10 mg Atorvastatin.
1004298|NCT00804843|O1|Outcome|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will receive 80 mg Atorvastatin + niacin
1004299|NCT00804843|E2|Reported Event|Statin 10 mg|"Participants in Russia and Brasil will receive 10 mg Simvastatin. All other participants will~recieve 10 mg Atorvastatin."
1004300|NCT00804843|E1|Reported Event|Statin 80 mg + Niacin Extended-release (ER)|Participants in Russia and Brasil will receive 80 mg Simvastatin + niacin. All other participants will recieve 80 mg Atorvastatin + niacin
1004301|NCT00806026|B7|Baseline|Total|Total of all reporting groups
1004302|NCT00806026|B6|Baseline|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004303|NCT00806026|B5|Baseline|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004304|NCT00806026|B4|Baseline|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004305|NCT00806026|B3|Baseline|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004306|NCT00806026|B2|Baseline|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004307|NCT00806026|B1|Baseline|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004308|NCT00806026|P6|Participant Flow|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004309|NCT00806026|P5|Participant Flow|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004310|NCT00806026|P4|Participant Flow|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004311|NCT00806026|P3|Participant Flow|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1005135|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1004312|NCT00806026|P2|Participant Flow|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004313|NCT00806026|P1|Participant Flow|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004314|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004315|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004316|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004317|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004318|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004319|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004320|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004321|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004322|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004323|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004324|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004325|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004326|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004327|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1005136|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004328|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004329|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004330|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004331|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004332|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004333|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004334|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004335|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004336|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004337|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004338|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004339|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004340|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004341|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004342|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004343|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1005137|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1004344|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004345|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004346|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004347|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004348|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004349|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004350|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004351|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004352|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004353|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004354|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004355|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004356|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004357|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004358|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004359|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1005138|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1005139|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004360|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004361|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004362|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004363|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004364|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004365|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004366|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004367|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004368|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004369|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004370|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004371|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004372|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004373|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004374|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004375|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1005140|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1004376|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004377|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004378|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004379|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004380|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004381|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004382|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004383|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004384|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004385|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004386|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004387|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004388|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004389|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004390|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004391|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1005141|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1004392|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004393|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004394|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004395|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004396|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004397|NCT00806026|O4|Outcome|Placebo|PBO capsules matched to PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg once daily following a two week up escalation for 12 weeks, re-randomized to 1 of the 3 active treatments (PGB 300 mg/ PPX 0.5 mg/ PPX 0.25 mg) and dose was escalated to the assigned fixed dose over 2 weeks and continued up to 40 weeks followed by dose tapering over 1 week similar to the active treatment.
1004398|NCT00806026|O3|Outcome|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004399|NCT00806026|O2|Outcome|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004400|NCT00806026|O1|Outcome|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004401|NCT00806026|E6|Reported Event|Placebo to Pramipexole 0.5 mg|PBO capsules matched to PPX 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) for 12 weeks, re-randomized to PPX 0.5 mg following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004402|NCT00806026|E5|Reported Event|Placebo to Pramipexole 0.25 mg|PBO capsules matched to PPX 0.25 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) for 12 weeks, re-randomized to PPX 0.25 mg following a two week up escalation (Day 1-5: 0.125 mg once daily and Day 6 onwards: 0.25 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004403|NCT00806026|E4|Reported Event|Placebo to Pregabalin 300 mg|PBO capsules matched to PGB 300 mg once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) for 12 weeks, re-randomized to PGB 300 mg following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 40 weeks. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004404|NCT00806026|E3|Reported Event|Pramipexole 0.5 mg|PPX capsule 0.5 mg once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6-10: 0.25 mg once daily and Day 11 onwards: 0.5 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.5 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.25 mg once daily (Day 1-3); 0.125 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1004405|NCT00806026|E2|Reported Event|Pramipexole 0.25 mg|Pramipexole (PPX) 0.25 mg capsules administered once daily following a two week up escalation (Day 1-5: 0.125 mg once daily; Day 6 onwards: 0.25 mg once daily) up to 52 weeks along with PBO capsule matched to PPX 0.25 mg in week 13 and 14. Participants were administered a tapering dose of PPX 0.125 mg once daily (Day 1-3) and matching PBO capsule once daily (Day 4-7) after completion of 52 weeks treatment.
1004406|NCT00806026|E1|Reported Event|Pregabalin 300 mg|Pregabalin (PGB) capsule 300 milligram (mg) once daily following a two week up escalation (Day 1-5: 75 mg once daily; Day 6-10: 150 mg once daily and Day 11 onwards: 300 mg once daily) up to 52 weeks along with placebo (PBO) capsule matched to PGB 300 mg in week 13 and 14. Participants were administered a tapering dose of PGB 150 mg once daily (Day 1-3); 75 mg once daily (Day 4-6) and matching PBO capsule once daily on Day 7 after completion of 52 weeks treatment.
1005142|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004407|NCT00805961|B1|Baseline|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
1004408|NCT00805961|P1|Participant Flow|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
1004409|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
1004410|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
1004411|NCT00805961|O1|Outcome|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
1004412|NCT00805961|E1|Reported Event|Overall Study|Radiotherapy administered in 2.0 Gy single daily fractions, Monday through Friday, to a total of at least 60 Gy. Temozolomide 75 mg/m2 orally daily and bevacizumab 10 mg/kg IV every 2 weeks, both beginning on day 1 of radiation therapy
1004413|NCT00805935|B5|Baseline|Total|Total of all reporting groups
1004414|NCT00805935|B4|Baseline|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004415|NCT00805935|B3|Baseline|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004416|NCT00805935|B2|Baseline|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004417|NCT00805935|B1|Baseline|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004418|NCT00805935|P4|Participant Flow|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004419|NCT00805935|P3|Participant Flow|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004420|NCT00805935|P2|Participant Flow|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004421|NCT00805935|P1|Participant Flow|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004422|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004423|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004424|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004425|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004426|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004427|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004428|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004429|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004430|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004431|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004432|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004433|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004434|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004435|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004436|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004437|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004438|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004439|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004440|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004441|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004442|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004443|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004609|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004444|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004445|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004446|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004447|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004448|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004449|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004450|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004451|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004452|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004453|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004454|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004455|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004456|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004457|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004458|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004459|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004489|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1005143|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1004460|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004461|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004462|NCT00805935|O2|Outcome|Follitropin Beta|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004463|NCT00805935|O1|Outcome|Menotropin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil."
1004464|NCT00805935|O4|Outcome|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004465|NCT00805935|O3|Outcome|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004466|NCT00805935|O2|Outcome|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004467|NCT00805935|O1|Outcome|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004468|NCT00805935|E4|Reported Event|Follitropin Beta/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004469|NCT00805935|E3|Reported Event|Follitropin Beta/Progesterone Vaginal Insert|"Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004470|NCT00805935|E2|Reported Event|Menotropin/Progesterone in Oil|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004471|NCT00805935|E1|Reported Event|Menotropin/Progesterone Vaginal Insert|"Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1004472|NCT00805870|B3|Baseline|Total|Total of all reporting groups
1004473|NCT00805870|B2|Baseline|Control|Wheat Germ Oil, 3 grams/day for 65 days
1004474|NCT00805870|B1|Baseline|Fish Oil|Lovaza, 3 grams/day for 65 days
1004475|NCT00805870|P2|Participant Flow|Control|Wheat Germ Oil, 3 grams/day for 65 days
1004476|NCT00805870|P1|Participant Flow|Fish Oil|Lovaza, 3 grams/day for 65 days
1004477|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
1004478|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
1004479|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
1004480|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
1004481|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
1004482|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
1004483|NCT00805870|O2|Outcome|Control|3.45 grams/day of wheat germ oil for 65 days
1004484|NCT00805870|O1|Outcome|Fish Oil|3 grams/day of fish oil for 65 days
1004485|NCT00805870|E2|Reported Event|Control|Wheat Germ Oil, 3 grams/day for 65 days
1004486|NCT00805870|E1|Reported Event|Fish Oil|Lovaza, 3 grams/day for 65 days
1004487|NCT00805792|B1|Baseline|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1004488|NCT00805792|P1|Participant Flow|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1004610|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004490|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1004491|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1004492|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1004493|NCT00805792|O1|Outcome|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1004494|NCT00805792|E1|Reported Event|Donepezil|Participants received treatment with donepezil within 24 hours after the onset of ischemic stroke symptoms. Participants received donepezil 5 mg/day for 30 days, followed by an increase to 10 mg/day for 60 days.
1004495|NCT00805766|B1|Baseline|TA-650|
1004496|NCT00805766|P1|Participant Flow|TA-650|"Screening period: From the beginning of TA-650 5 mg/kg administration to the beginning of TA-650 10 mg/kg administration in the increased dose period in order to confirm that the effects of treatment with TA-650 5 mg/kg at 8-week intervals were insufficient. The screening period was to be up to 16 weeks. Patients who did not satisfy the dose-increasing criteria discontinued study treatment.Patients who discontinued study treatment during the screening period were to be evaluated until withdrawal.~Increased dose period: From the beginning of administration of TA-650 10 mg/kg to evaluation at week 40. Patients who discontinued study treatment during the increased dose period were to be evaluated until withdrawal."
1004497|NCT00805766|O1|Outcome|TA-650|
1004498|NCT00805766|O1|Outcome|TA-650|
1004499|NCT00805766|E3|Reported Event|Increased Dose Period|
1004500|NCT00805766|E2|Reported Event|Screening Period|
1004501|NCT00805766|E1|Reported Event|Entire Evaluation Period|Screening Period + Increased Dose Period
1004502|NCT00805740|B3|Baseline|Total|Total of all reporting groups
1004503|NCT00805740|B2|Baseline|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004504|NCT00805740|B1|Baseline|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004505|NCT00805740|P2|Participant Flow|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004506|NCT00805740|P1|Participant Flow|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004507|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004508|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004509|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004510|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004511|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004601|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004602|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
1004512|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004513|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004514|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004515|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004516|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004517|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004518|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004519|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004520|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004521|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004522|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004523|NCT00805740|O2|Outcome|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004524|NCT00805740|O1|Outcome|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004525|NCT00805740|E2|Reported Event|Caspofungin|Caspofungin at a loading dose 70 mg infusion intravenously over 1 hour, administered prior to or following 2 placebo infusions, each matched to anidulafungin 100 mg infusion, intravenously over 1.5 hours each on Day 1. Caspofungin 50 mg infusion intravenously over 1 hour once daily, administered prior to or following placebo matched to anidulafungin 100 mg infusion intravenously over 1.5 hours once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004603|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004604|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004526|NCT00805740|E1|Reported Event|Anidulafungin|Anidulafungin at a loading dose 200 milligram (mg) as two 100 mg consecutive infusions intravenously over 1.5 hours each, administered prior to or following placebo matched to caspofungin 70 mg infusion intravenously over 1 hour on Day 1. Anidulafungin 100 mg infusion intravenously over 1.5 hours once daily, administered prior to or following placebo matched to caspofungin 50 mg infusion intravenously over 1 hour once daily starting from Day 2 to end of treatment (Day 14 to Day 42).
1004527|NCT00805675|B4|Baseline|Total|Total of all reporting groups
1004528|NCT00805675|B3|Baseline|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004529|NCT00805675|B2|Baseline|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004530|NCT00805675|B1|Baseline|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004531|NCT00805675|P3|Participant Flow|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004532|NCT00805675|P2|Participant Flow|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004533|NCT00805675|P1|Participant Flow|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004534|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004535|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004536|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004537|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1005144|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1004538|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004539|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004540|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004541|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004542|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004543|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004544|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004545|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004546|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004547|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004548|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1005145|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004549|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004550|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004551|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004552|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004553|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004554|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004555|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004556|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004557|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004558|NCT00805675|O3|Outcome|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004559|NCT00805675|O2|Outcome|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004560|NCT00805675|O1|Outcome|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004561|NCT00805675|E3|Reported Event|Telbivudine 600 mg and Tenofovir 300 mg|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD and Tenofovir (TDF) 300 mg (equivalent to Tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004562|NCT00805675|E2|Reported Event|Tenofovir Disproxil Fumarate 300 mg Monotherapy|All patients in this arm were randomized to receive Tenofovir disoproxil fumarate 300 mg(equivalent to tenofovir disoproxil 245 mg)QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004563|NCT00805675|E1|Reported Event|Telbivudine 600 mg Monotherapy|All patients in this arm were randomized to receive Telbivudine (LDT) 600 mg QD. Patients were randomized prior to the first dose of study medication, which was defined as the study Baseline (Day 1) Visit. Subsequently, patients returned to the clinic at Days 2, 4, 6, 8, 11, 15 (Wk 2), 22 (Wk 3), 29 (Wk 4), 43 (Wk 6), 57 (Wk 8), and 85 (Wk 12) during the 12 weeks treatment phase. Furthermore, patients scheduled to Post-treatment Follow-up visits at Day 113 (Wk 16), Day 141 (Wk 20), and Day 169 (Wk 24) . At each of these visits routine tests and adverse event inquiry were performed.
1004564|NCT00805545|B3|Baseline|Total|Total of all reporting groups
1004565|NCT00805545|B2|Baseline|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
1004566|NCT00805545|B1|Baseline|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
1004567|NCT00805545|P2|Participant Flow|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
1004568|NCT00805545|P1|Participant Flow|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
1004569|NCT00805545|O2|Outcome|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
1004570|NCT00805545|O1|Outcome|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
1004571|NCT00805545|E2|Reported Event|Post Cord-clamping Antibiotics|Group of patients that will receive antibiotics immediately after clamping the umbilical cord
1004572|NCT00805545|E1|Reported Event|Preoperative Antibiotics|Group of patients that will receive antibiotics 30-60 minutes prior to incision
1004573|NCT00805493|B4|Baseline|Total|Total of all reporting groups
1004574|NCT00805493|B3|Baseline|Not Randomized|
1004575|NCT00805493|B2|Baseline|Placebo|
1004576|NCT00805493|B1|Baseline|Riluzole|
1004577|NCT00805493|P3|Participant Flow|Not Randomized|Those who withdrew prior to the decision to randomize
1004578|NCT00805493|P2|Participant Flow|Placebo|Those randomized to receive placebo
1004579|NCT00805493|P1|Participant Flow|Riluzole|Those randomized to riluzole
1004580|NCT00805493|O3|Outcome|Riluzole|The group randomized to receive riluzole
1004581|NCT00805493|O2|Outcome|Not Randomized|Participants who withdrew prior to the decision to randomize
1004582|NCT00805493|O1|Outcome|Placebo|The group randomized to receive placebo
1004583|NCT00805493|O3|Outcome|Not Randomized|Those who withdrew prior to the decision to randomize
1004584|NCT00805493|O2|Outcome|Placebo|
1004585|NCT00805493|O1|Outcome|Riluzole|The group randomized to riluzole
1004586|NCT00805493|E3|Reported Event|Not Randomized|
1004587|NCT00805493|E2|Reported Event|Placebo|
1004588|NCT00805493|E1|Reported Event|Riluzole|
1004589|NCT00805480|B5|Baseline|Total|Total of all reporting groups
1004590|NCT00805480|B4|Baseline|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
1004591|NCT00805480|B3|Baseline|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004592|NCT00805480|B2|Baseline|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004593|NCT00805480|B1|Baseline|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004594|NCT00805480|P4|Participant Flow|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
1004595|NCT00805480|P3|Participant Flow|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004596|NCT00805480|P2|Participant Flow|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004597|NCT00805480|P1|Participant Flow|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004598|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
1004599|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004600|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1005146|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1004611|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004612|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004613|NCT00805480|O4|Outcome|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
1004614|NCT00805480|O3|Outcome|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004615|NCT00805480|O2|Outcome|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004616|NCT00805480|O1|Outcome|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004617|NCT00805480|E4|Reported Event|Placebo|Participants randomized to this arm received matching placebo to AIN457 on days 1, 15 and 29
1004618|NCT00805480|E3|Reported Event|AIN457 10 mg/kg x3|Participants randomized to this arm received AIN457 3 mg/kg on days 1, 15 and 29.
1004619|NCT00805480|E2|Reported Event|AIN457 10 mg/kg|Participants randomized to this arm received AIN457 10 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004620|NCT00805480|E1|Reported Event|AIN457 3 mg/kg|Participants randomized to this arm received AIN457 3 mg/kg on day 1, and then matching placebo on days 15 and 29.
1004621|NCT00805467|B5|Baseline|Total|Total of all reporting groups
1004622|NCT00805467|B4|Baseline|Fostamatinib 100 mg Bid|Oral treatment
1004623|NCT00805467|B3|Baseline|Fostamatinib 150 mg qd|Oral treatment
1004624|NCT00805467|B2|Baseline|Fostamatinib 100 mg qd|Oral treatment
1004625|NCT00805467|B1|Baseline|Fostamatinib 50 mg Bid|Oral treatment
1004626|NCT00805467|P4|Participant Flow|Fostamatinib 100 mg Bid|Oral treatment
1004627|NCT00805467|P3|Participant Flow|Fostamatinib 150 mg qd|Oral treatment
1004628|NCT00805467|P2|Participant Flow|Fostamatinib 100 mg qd|Oral treatment
1004629|NCT00805467|P1|Participant Flow|Fostamatinib 50 mg Bid|Oral treatment
1004630|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
1004631|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
1004632|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
1004633|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
1004634|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
1004635|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
1004636|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
1004637|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
1004638|NCT00805467|O4|Outcome|Fostamatinib 100 mg Bid|Oral treatment
1004639|NCT00805467|O3|Outcome|Fostamatinib 150 mg qd|Oral treatment
1004640|NCT00805467|O2|Outcome|Fostamatinib 100 mg qd|Oral treatment
1004641|NCT00805467|O1|Outcome|Fostamatinib 50 mg Bid|Oral treatment
1004642|NCT00805467|E4|Reported Event|50 MG BID|
1004643|NCT00805467|E3|Reported Event|150 MG QD|
1004644|NCT00805467|E2|Reported Event|100 MG QD|
1004645|NCT00805467|E1|Reported Event|100 MG BID|
1004646|NCT00805389|B6|Baseline|Total|Total of all reporting groups
1004647|NCT00805389|B5|Baseline|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004648|NCT00805389|B4|Baseline|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004649|NCT00805389|B3|Baseline|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004650|NCT00805389|B2|Baseline|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004651|NCT00805389|B1|Baseline|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004713|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004652|NCT00805389|P5|Participant Flow|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004653|NCT00805389|P4|Participant Flow|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004654|NCT00805389|P3|Participant Flow|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004655|NCT00805389|P2|Participant Flow|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004656|NCT00805389|P1|Participant Flow|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004657|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004658|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004659|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004660|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004661|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004662|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004663|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004919|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005147|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1004664|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004665|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004666|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004667|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004668|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004669|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004670|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004671|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004672|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004673|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004674|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004675|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004920|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005148|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004676|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004677|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004678|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004679|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004680|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004681|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004682|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004683|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004684|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004685|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004686|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004687|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004921|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005149|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1004688|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004689|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004690|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004691|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004692|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004693|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004694|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004695|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004696|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004697|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004698|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004699|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004922|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 (with dose reduction to 60 mg/m2 if required) once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005150|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1004700|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004701|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004702|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004703|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004704|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004705|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004706|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004707|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004708|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004709|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004710|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004711|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004712|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004714|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004715|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004716|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004717|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004718|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004719|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004720|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004721|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004722|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004723|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004724|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004725|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004726|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1005151|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004727|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004728|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004729|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004730|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004731|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004732|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004733|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004734|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004735|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004736|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004737|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004738|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004739|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004740|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004741|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004742|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004743|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004744|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004745|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004746|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004747|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004748|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004749|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004750|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004751|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004752|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004753|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004754|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004755|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004756|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004757|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004758|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004759|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004760|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004761|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004762|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004763|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004764|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004765|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004923|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005152|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1005153|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1004766|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004767|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004768|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004769|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004770|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004771|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004772|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004773|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004774|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004775|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004776|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004777|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004924|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005154|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1005155|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1004778|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004779|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004780|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004781|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004782|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004783|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004784|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004785|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004786|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004787|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004788|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004789|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004790|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004925|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005156|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1005157|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1004791|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004792|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004793|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004794|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004795|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004796|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004797|NCT00805389|O5|Outcome|Engerix-B – Non-HLA Subsets Group|This group consisted in the subjects in the Engerix-B Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Engerix-B™, at Days 0 and 30. The Engerix-B™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004798|NCT00805389|O4|Outcome|Fendrix – Non-HLA Subsets Group|This group consisted in the subjects in the Fendrix Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of Fendrix™, at Days 0 and 30. The Fendrix™ vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004799|NCT00805389|O3|Outcome|GSK223192A 3 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 3 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. The GSK223192A vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004800|NCT00805389|O2|Outcome|GSK223192A 2 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 2 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004801|NCT00805389|O1|Outcome|GSK223192A 1 – Non-HLA Subsets Group|This group consisted in the subjects in the GSK223192A 1 Group who were not identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype. Subjects in this group were aged between, and including, 18 and 45 years at the time of first vaccination and received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. The GSK223192A vaccine antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004802|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004803|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004804|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004926|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005158|NCT00804648|E3|Reported Event|Timolol Maleate Gel Forming Solution 0.5%|
1004805|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004806|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004807|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004808|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004809|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004810|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004811|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004812|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004813|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004814|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004815|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004816|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004817|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004927|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005159|NCT00804648|E2|Reported Event|Timolol Maleate 0.5%|
1004818|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004819|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004820|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004821|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004822|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004823|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004824|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004825|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004826|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004827|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004828|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004829|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004830|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004928|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005160|NCT00804648|E1|Reported Event|Timolol Hemihydrate 0.5%|
1005161|NCT00804609|B3|Baseline|Total|Total of all reporting groups
1004831|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004832|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004833|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004834|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004835|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004836|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004837|NCT00805389|O5|Outcome|Engerix-B – HLA Subsets Group|This group consisted in the subset of subjects in the Engerix-B Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004838|NCT00805389|O4|Outcome|Fendrix – HLA Subsets Group|This group consisted in the subset of subjects in the Fendrix Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004839|NCT00805389|O3|Outcome|GSK223192A 3 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 3 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004840|NCT00805389|O2|Outcome|GSK223192A 2 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 2 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004841|NCT00805389|O1|Outcome|GSK223192A 1 – HLA Subsets Group|This group consisted in the subset of subjects in the GSK223192A 1 Group identified with a pre-defined Human Leukocytes Antigen (HLA) Class I or II subtype aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30, followed by one booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004842|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004843|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004929|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004844|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004845|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004846|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004847|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004848|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004849|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004850|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004851|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004852|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004853|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004854|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004855|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004930|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1007084|NCT00798161|B6|Baseline|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1004856|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004857|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004858|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004859|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004860|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004861|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004862|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004863|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004864|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004865|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004866|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004867|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004931|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1020846|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1004868|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004869|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004870|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004871|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004872|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004873|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004874|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004875|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004876|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004877|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004878|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004879|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004932|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1007085|NCT00798161|B5|Baseline|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1004880|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004881|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004882|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004883|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004884|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004885|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004886|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004887|NCT00805389|O5|Outcome|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004888|NCT00805389|O4|Outcome|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004889|NCT00805389|O3|Outcome|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004890|NCT00805389|O2|Outcome|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004891|NCT00805389|O1|Outcome|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004933|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1020847|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1004892|NCT00805389|E5|Reported Event|Engerix-B Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Engerix-B™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Engerix-B™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004893|NCT00805389|E4|Reported Event|Fendrix Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of Fendrix™ vaccine at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The Fendrix™ vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004894|NCT00805389|E3|Reported Event|GSK223192A 3 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 3, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004895|NCT00805389|E2|Reported Event|GSK223192A 2 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 2, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004896|NCT00805389|E1|Reported Event|GSK223192A 1 Group|Subjects aged between, and including, 18 and 45 years at the time of first vaccination received 2 doses of GSK223192A vaccine, lot 1, at Days 0 and 30. 2 subsets of subjects within the group – subjects identified with either a pre-defined Human Leukocytes Antigen (HLA) Class I subtype (Subset 1) or a pre-defined HLA Class II subtype (Subset 2) – additionally received 1 booster dose of Hepatitis B surface antigens (HBsAg) at Day 360. The GSK223192A vaccine and HBsAg antigens were administered intramuscularly into the deltoid muscle of the non-dominant arm.
1004897|NCT00805285|B1|Baseline|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
1004898|NCT00805285|P1|Participant Flow|Combination Oral Budesonide and Rectal Hydrocortisone|Budesonide 9 mg po daily and Rectal Hydrocortisone once daily
1004899|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
1004900|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
1004901|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
1004902|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
1004903|NCT00805285|O1|Outcome|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
1004904|NCT00805285|E1|Reported Event|Combination Oral Budesonide and Rectal Hydrocortisone|Intervention Arm
1004905|NCT00805194|B3|Baseline|Total|Total of all reporting groups
1004906|NCT00805194|B2|Baseline|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004907|NCT00805194|B1|Baseline|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004908|NCT00805194|P2|Participant Flow|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004909|NCT00805194|P1|Participant Flow|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004910|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004911|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004912|NCT00805194|O2|Outcome|Nintedanib 150 Bid mg Plus Docetaxel|Nintedanib 150 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004913|NCT00805194|O1|Outcome|Nitedanib 200 mg Bid Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004914|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004915|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004916|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004917|NCT00805194|O1|Outcome|Nitedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004918|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1005201|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1004934|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004935|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004936|NCT00805194|O2|Outcome|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004937|NCT00805194|O1|Outcome|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004938|NCT00805194|E2|Reported Event|Placebo Plus Docetaxel|Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004939|NCT00805194|E1|Reported Event|Nintedanib Plus Docetaxel|Nintedanib 200 mg twice daily administered orally in a form of a soft gelatin capsule plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h).
1004940|NCT00805142|B3|Baseline|Total|Total of all reporting groups
1004941|NCT00805142|B2|Baseline|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004942|NCT00805142|B1|Baseline|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004943|NCT00805142|P2|Participant Flow|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004944|NCT00805142|P1|Participant Flow|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (JNS024PR, PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004945|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004946|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004947|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1005202|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1004948|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004949|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004950|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004951|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004952|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004953|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004954|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004963|NCT00805142|O2|Outcome|Opioid-Switch Participants Maintenance Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. The maintenance period (15-19 days) was defined as the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004992|NCT00804986|P3|Participant Flow|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004955|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004956|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004957|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004958|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004959|NCT00805142|O2|Outcome|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004960|NCT00805142|O1|Outcome|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004961|NCT00805142|O2|Outcome|Opioid-Switch Participants Titration Period (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Initial dose of tapentadol PR was selected according to the daily dose of opioid (morphine sustained release (SR) preparation, oxycodone hydrochloride (HCl) SR tablet or fentanyl patch). Equivalent dose of the tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day.
1004962|NCT00805142|O1|Outcome|Opioid-Naive Participants Titration Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Titration period (3-14 days) was the duration between start of treatment to the day before the initial dose in the maintenance period. Treatment was initiated with tapentadol PR 25 mg oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day.
1004991|NCT00804986|P4|Participant Flow|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005092|NCT00804713|E1|Reported Event|All Study Participants|Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot
1004964|NCT00805142|O1|Outcome|Opioid-Naive Participants Maintenance Period (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled adequately with non-opioid medications. The maintenance period (15-19 days) was the duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol prolonged release (PR) oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004965|NCT00805142|E2|Reported Event|Opioid-Switch Participants (Tapentadol PR)|Opioid-switching participants were defined as those who had moderate to severe cancer pain that was controlled sufficiently with opioid therapies. Treatment period comprised of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in maintenance period. Initial dose of tapentadol PR was selected according to daily dose of opioid (morphine sustained release [SR] preparation, oxycodone hydrochloride [HCl] SR tablet or fentanyl patch). Equivalent dose of tapentadol PR oral tablet twice daily given depending on daily dose of opioid at completion of Screening period. Maximum dose limit was 500 mg per day. Participants were then assigned to treatment in maintenance period (15-19 days). Maintenance period was defined as duration between first dose and final assessment in maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at same dose used on last day of titration period.
1004966|NCT00805142|E1|Reported Event|Opioid-Naive Participants (Tapentadol PR)|Opioid-naive participants were defined as those who had moderate to severe cancer pain that was not controlled sufficiently with non-opioid medications. Treatment period comprises of Titration and Maintenance period. Titration period (3-14 days) was duration between start of treatment to day before initial dose in the maintenance period. Treatment was initiated with tapentadol prolonged release (PR) 25 milligram (mg) oral tablet twice daily. Dose was increased or decreased as per Investigator’s discretion up to Day 14. Maximum dose limit was 500 mg per day. Participants were then assigned to the treatment in the maintenance period (15-19 days). The maintenance period was duration between the first dose and the final assessment in the maintenance period. Participants received tapentadol PR oral tablet twice daily for 5 days at the same dose used on last day of titration period.
1004967|NCT00805038|B3|Baseline|Total|Total of all reporting groups
1004968|NCT00805038|B2|Baseline|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
1004969|NCT00805038|B1|Baseline|Usual Care|Usual care received by participants
1004970|NCT00805038|P2|Participant Flow|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
1004971|NCT00805038|P1|Participant Flow|Usual Care|Usual care received by participants
1004972|NCT00805038|O2|Outcome|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
1004973|NCT00805038|O1|Outcome|Usual Care|Usual care received by participants
1004974|NCT00805038|E2|Reported Event|Transplant Navigator|Navigator will assist patients in completing steps in transplant process
1004975|NCT00805038|E1|Reported Event|Usual Care|Usual care received by participants
1004976|NCT00805025|B1|Baseline|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
1004977|NCT00805025|P1|Participant Flow|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of aztreonam for inhalation solution (AZLI) 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
1004978|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
1004979|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
1004980|NCT00805025|O1|Outcome|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
1004981|NCT00805025|E1|Reported Event|AZLI|Participants were evaluated beginning 14 days prior to starting a 28-day course of AZLI 75 mg three times daily via investigational nebulizer (Day 0 to Day 28), followed by post-treatment assessments every 14 days through Day 56, for a total of 70 days of participation in the study.
1004982|NCT00804986|B7|Baseline|Total|Total of all reporting groups
1004983|NCT00804986|B6|Baseline|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004984|NCT00804986|B5|Baseline|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004985|NCT00804986|B4|Baseline|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004986|NCT00804986|B3|Baseline|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004987|NCT00804986|B2|Baseline|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004988|NCT00804986|B1|Baseline|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004989|NCT00804986|P6|Participant Flow|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004990|NCT00804986|P5|Participant Flow|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1020848|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1004993|NCT00804986|P2|Participant Flow|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004994|NCT00804986|P1|Participant Flow|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004995|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004996|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004997|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004998|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1004999|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005000|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005001|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005002|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005003|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005004|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005005|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005006|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005007|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005008|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005009|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005010|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005011|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005012|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005013|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005014|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005015|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005016|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005017|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005018|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005019|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005020|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005021|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005022|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005023|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005024|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005025|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1020849|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1005026|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005027|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005028|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005029|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005030|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005031|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005032|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005033|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005034|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005035|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005036|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005037|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005038|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005039|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005040|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005041|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005042|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005043|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005044|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005045|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005046|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005047|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005048|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005049|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005050|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005051|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005052|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005053|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005054|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005055|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005056|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005057|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005058|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1020850|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1005059|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005060|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005061|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005062|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005063|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005064|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005065|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005066|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005067|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005068|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005069|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005070|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005071|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005072|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005073|NCT00804986|O6|Outcome|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005074|NCT00804986|O5|Outcome|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005075|NCT00804986|O4|Outcome|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005076|NCT00804986|O3|Outcome|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005077|NCT00804986|O2|Outcome|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005078|NCT00804986|O1|Outcome|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005079|NCT00804986|E6|Reported Event|Placebo|Once weekly, subcutaneous injection of placebo for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005080|NCT00804986|E5|Reported Event|17.6 mg LY2428757|Once weekly, subcutaneous injection of 17.6 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005081|NCT00804986|E4|Reported Event|12.0 mg LY2428757|Once weekly, subcutaneous injection of 12.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005082|NCT00804986|E3|Reported Event|6.2 mg LY2428757|Once weekly, subcutaneous injection of 6.2 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005083|NCT00804986|E2|Reported Event|2.0 mg LY2428757|Once weekly, subcutaneous injection of 2.0 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005084|NCT00804986|E1|Reported Event|0.5 mg LY2428757|Once weekly, subcutaneous injection of 0.5 mg LY2428757 for 12 weeks. All injections were administered by study site personnel who were blinded to treatment assignment.
1005085|NCT00804713|B1|Baseline|All Study Participants|Subjects administered the Tuberculosis skin test (TST), Battey skin test, QFT-GIT, and T-spot
1005086|NCT00804713|P1|Participant Flow|All Study Participants|Subjects administered the tuberculosis skin test (TST), Battey skin test, Quantiferon Gold-in-tube (QFT-GIT), and T-Spot
1005087|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test~Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
1005088|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot~All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.~All study participants: Administer TB Skin test~All study participants: Perform QFT-GIT TB test~All study participants: Perform T-Spot TB test"
1005089|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test, Battey skin test, QFT-GIT, and T-Spot~All study participants: 0.1 mcg/mL (1 dose) Battey skin test antigen administered using the Mantoux method.~All study participants: Administer TB Skin test~All study participants: Perform QFT-GIT TB test~All study participants: Perform T-Spot TB test"
1005090|NCT00804713|O1|Outcome|QFT-GIT|"Subjects administered the QFT-GIT TB test~QFT-GIT: Perform QFT-GIT TB test"
1005091|NCT00804713|O1|Outcome|All Study Participants|"Subjects administered the TB skin test~Tuberculin Skin Test: Administer TB Skin test, Battey skin test, QFT, and T-Spot"
1005094|NCT00804687|P6|Participant Flow|Pseudoephedrine Then Placebo Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
1005095|NCT00804687|P5|Participant Flow|Pseudoephedrine Then JNJ-39220675 Then Placebo|Single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
1005096|NCT00804687|P4|Participant Flow|Placebo Then Pseudoephedrine Then JNJ-39220675|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in second treatment period; and then single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
1005097|NCT00804687|P3|Participant Flow|Placebo Then JNJ-39220675 Then Pseudoephedrine|Single-dose of 1 ml placebo solution orally and placebo tablet orally in first treatment period; after that single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
1005098|NCT00804687|P2|Participant Flow|JNJ-39220675 Then Placebo Then Pseudoephedrine|Single-dose of JNJ-39220675 as 1 ml of 10 mg/ml solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and placebo tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and 60 mg pseudoephedrine tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
1005099|NCT00804687|P1|Participant Flow|JNJ-39220675 Then Pseudoephedrine Then Placebo|Single-dose of JNJ-39220675 as 1 milliliter (ml) of 10 milligram/milliliter (mg/ml) solution orally and placebo tablet orally in first treatment period; after that single-dose of 1 ml placebo solution orally and 60 milligram (mg) pseudoephedrine tablet orally in second treatment period; and then single-dose of 1 ml placebo solution orally and placebo tablet orally in third treatment period. A washout period of at least 6 days was maintained between each treatment period.
1005100|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
1005101|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
1005102|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
1005103|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
1005104|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
1005105|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
1005106|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
1005107|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
1005108|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
1005109|NCT00804687|O3|Outcome|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
1005110|NCT00804687|O2|Outcome|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
1005111|NCT00804687|O1|Outcome|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
1005112|NCT00804687|E3|Reported Event|Pseudoephedrine|Single-dose of 60 milligram pseudoephedrine tablet orally in one of the treatment periods.
1005113|NCT00804687|E2|Reported Event|JNJ-39220675|Single-dose of JNJ-39220675 as 1 ml of 10 milligram/milliliter solution orally in one of the treatment periods.
1005114|NCT00804687|E1|Reported Event|Placebo|Single-dose of 1 milliliter placebo solution orally and/or placebo tablet orally in one of the treatment periods.
1005115|NCT00804648|B1|Baseline|Overall|
1005116|NCT00804648|P6|Participant Flow|Maleate Gel/Maleate/Hemihydrate|Period 1 - Timolol maleate gel forming solution 0.5% Period 2 - Timolol maleate 0.5% Period 3 - Timolol hemihydrate 0.5%
1005117|NCT00804648|P5|Participant Flow|Maleate/Hemihydrate/Maleate Gel|Period 1 - Timolol maleate 0.5% Period 2 - Timolol hemihydrate 0.5% Period 3 - Timolol maleate gel forming solution 0.5%
1005118|NCT00804648|P4|Participant Flow|Hemihydrate/Maleate Gel/Maleate|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol maleate 0.5%
1005119|NCT00804648|P3|Participant Flow|Maleate Gel/Hemihydrate/Maleate|Period one - Timolol maleate gel forming solution 0.5% Period two - Timolol hemihydrate 0.5% Period three - Timolol maleate 0.5%
1005120|NCT00804648|P2|Participant Flow|Maleate/Maleate Gel/Hemihydrate|Period one - Timolol maleate 0.5% Period two - Timolol maleate gel forming solution 0.5% Period three - Timolol hemihydrate 0.5%
1005121|NCT00804648|P1|Participant Flow|Hemihydrate/Maleate/Maleate Gel|Period one - Timolol hemihydrate 0.5% Period two - Timolol maleate 0.5% Period three - Timolol maleate gel forming solution 0.5%
1005122|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1005123|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1005124|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1005125|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1005126|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1005127|NCT00804648|O1|Outcome|Timolol Hemihydrate 0.5%|
1005128|NCT00804648|O3|Outcome|Timolol Maleate Gel Forming Solution 0.5%|
1005129|NCT00804648|O2|Outcome|Timolol Maleate 0.5%|
1005162|NCT00804609|B2|Baseline|Epidural DepoDur Following Spinal Anesthetic|"Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.~DepoDur: Participants underwent an elective cesarean delivery with a combined spinal/epidural. All patients received 12 mg hyperbaric bupivacaine with 20 mcg fentanyl administered intrathecally. No local anesthetic was administered through the catheter. The combined spinal-epidural was performed at the L2/L3 or L3/L4 interspace and the intrathecal dose was injected over 5-10 s. A multiple orifice epidural catheter was threaded 5 cm into the epidural space.~Provided delivery had occurred 60 minutes after the intrathecal dose patients received EREM 8 mg (DepoDur™) through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug."
1005163|NCT00804609|B1|Baseline|Epidural DepoDur Following Epidural Lidocaine Administration|"Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.~DepoDur: All participant underwent cesarean delivery. An epidural top-up anesthetic consisting of 2% lidocaine with epinephrine 1:200,000 and sodium bicarbonate (1 meq per 10 mL lidocaine) was given. The lidocaine solution was administered in 5 mL increments every 2.5 minutes until a T6 sensory level to touch was attained. Patients also received a 100 mcg dose of fentanyl epidurally after the lidocaine solution had been administered.~Provided delivery had occurred at least 60 minutes after the initial lidocaine administration, patients received EREM 8 mg (DepoDur™) administered through the epidural catheter. A 2 mL epidural saline flush was administered before and after drug administration."
1005164|NCT00804609|P2|Participant Flow|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
1005165|NCT00804609|P1|Participant Flow|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
1005166|NCT00804609|O2|Outcome|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
1005167|NCT00804609|O1|Outcome|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
1005168|NCT00804609|E2|Reported Event|Epidural DepoDur Following Spinal Anesthetic|Epidural DepoDur was administered 60 minutes after a standard spinal anesthetic. No prior epidural local anesthetic was used prior to DepoDur in this group assignment.
1005169|NCT00804609|E1|Reported Event|Epidural DepoDur Following Epidural Lidocaine Administration|Epidural DepoDur was administered 60 minutes after an epidural Lidocaine top-up for surgical anesthetic in cesarean section patients.
1005170|NCT00804596|B1|Baseline|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
1005171|NCT00804596|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
1005172|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
1005173|NCT00804596|O1|Outcome|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
1005174|NCT00804596|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes and healthcare professionals (HCPs) use a new blood glucose monitoring system with subject capillary blood.
1005175|NCT00804570|B3|Baseline|Total|Total of all reporting groups
1005176|NCT00804570|B2|Baseline|Placebo|once daily, orally, 16 weeks
1005177|NCT00804570|B1|Baseline|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005178|NCT00804570|P2|Participant Flow|Placebo|once daily, orally, 16 weeks
1005179|NCT00804570|P1|Participant Flow|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005180|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005181|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005182|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005183|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005184|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005185|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005186|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005187|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005188|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005189|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005190|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005191|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005192|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005193|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005194|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005195|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005196|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005197|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005198|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
1005199|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
1005200|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005203|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005204|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005205|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005206|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005207|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005208|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005209|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005210|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005211|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005212|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005213|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005214|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005215|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005216|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005217|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005218|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005219|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005220|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005221|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005222|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005223|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005224|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005225|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005226|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005227|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005228|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005229|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005230|NCT00804570|O2|Outcome|Placebo|once daily, orally, 16 weeks
1005231|NCT00804570|O1|Outcome|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks
1005232|NCT00804570|E2|Reported Event|Placebo|once daily (QD), orally (PO), 16 weeks
1005233|NCT00804570|E1|Reported Event|LY2196044|250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily (QD), orally (PO), 16 weeks
1005234|NCT00804193|B4|Baseline|Total|Total of all reporting groups
1005235|NCT00804193|B3|Baseline|Vehicle Product|placebo of test product
1005236|NCT00804193|B2|Baseline|Reference Product|Loprox® Topical Suspension 0.77%
1005237|NCT00804193|B1|Baseline|Test Product|Ciclopirox Olamine Topical Suspension
1005238|NCT00804193|P3|Participant Flow|Vehicle Product|placebo of test product was applied treatment two times a day for 4 weeks
1005239|NCT00804193|P2|Participant Flow|Reference Product|Loprox® Topical Suspension 0.77%; the Reference Product was applied treatment two times a day for 4 weeks
1005240|NCT00804193|P1|Participant Flow|Test Product|Ciclopirox Olamine Topical Suspension; the Test Product was applied treatment two times a day for 4 weeks
1005241|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
1005242|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
1005243|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
1005244|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
1005245|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
1005246|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
1005247|NCT00804193|O3|Outcome|Vehicle Product|placebo of test product
1005248|NCT00804193|O2|Outcome|Reference Product|Loprox® Topical Suspension 0.77%
1005249|NCT00804193|O1|Outcome|Test Product|Ciclopirox Olamine Topical Suspension
1005250|NCT00804193|E3|Reported Event|Vehicle Product|placebo of test product
1005251|NCT00804193|E2|Reported Event|Reference Product|Loprox® Topical Suspension 0.77%
1005252|NCT00804193|E1|Reported Event|Test Product|Ciclopirox Olamine Topical Suspension
1005253|NCT00803959|B3|Baseline|Total|Total of all reporting groups
1005254|NCT00803959|B2|Baseline|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005255|NCT00803959|B1|Baseline|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005256|NCT00803959|P2|Participant Flow|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005257|NCT00803959|P1|Participant Flow|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005258|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005259|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1020851|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1005260|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005261|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005262|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005263|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005264|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005265|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005266|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005267|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005268|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005269|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005270|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005271|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005272|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005273|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005274|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005275|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005276|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005277|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005278|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005279|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005280|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005281|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005282|NCT00803959|O2|Outcome|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005283|NCT00803959|O1|Outcome|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005284|NCT00803959|E2|Reported Event|Urodynamic Testing (UDS Arm)|UDS is conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005285|NCT00803959|E1|Reported Event|Office Evaluation Only (no UDS)|UDS is not conducted during office evaluation visit prior to surgery for women desiring surgery for diagnosed, uncomplicated predominant stress urinary incontinence.
1005286|NCT00803790|B3|Baseline|Total|Total of all reporting groups
1005287|NCT00803790|B2|Baseline|Part 2|"Alendronate+vitamin D combo, then vitamin D: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets. A washout of at least 12 days separated each treatment period.~Vitamin D, then alendronate+vitamin D combo: In Period 1 participants received a single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
1005288|NCT00803790|B1|Baseline|Part 1|"Alendronate+vitamin D combo, then alendronate: In Period 1 participants received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet, and in Period 2 a single dose of 70mg alendronate tablet. A washout of at least 12 days separated each treatment period.~Alendronate, then alendronate+vitamin D combo: In Period 1 participants received 70mg alendronate tablet, and in Period 2 a single dose of 70mg alendronate+5600 IU vitamin D combination tablet. A washout of at least 12 days separated each treatment period."
1020852|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1005289|NCT00803790|P4|Participant Flow|Part 2 Vitamin D, Then Alendronate+Vitamin D Combo|Participants in Part 2 received a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
1005290|NCT00803790|P3|Participant Flow|Part 2 Alendronate+Vitamin D Combo, Then Vitamin D|Participants in Part 2 received a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 1 followed by a single dose of 5600 IU vitamin D, administered as two 2800 IU tablets in Period 2. A washout of at least 12 days separated each treatment period.
1005291|NCT00803790|P2|Participant Flow|Part 1 Alendronate, Then Alendronate+Vitamin D Combo|Participants in Part 1 received a single dose of 70mg alendronate tablet in Period 1 followed by a single dose of 70mg alendronate+5600 IU vitamin D combination tablet in Period 2. A washout of at least 12 days separated each treatment period.
1005292|NCT00803790|P1|Participant Flow|Part 1 Alendronate+Vitamin D Combo, Then Alendronate|Participants in Part 1 received a single dose of 70mg alendronate+5600 International Units (IU) vitamin D combination tablet in Period 1 followed by a single dose of 70mg alendronate tablet in Period 2. A washout of at least 12 days separated each treatment period.
1005293|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
1005294|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
1005295|NCT00803790|O2|Outcome|Vitamin D|Single dose of 5600 IU vitamin D administered as 2 x 2800 IU tablets
1005296|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|A single dose of 70mg alendronate+5600 IU vitamin D combination tablet
1005297|NCT00803790|O2|Outcome|Alendronate|Single dose of 70mg alendronate tablet
1005298|NCT00803790|O1|Outcome|Alendronate+Vitamin D Combo|Single dose of 70mg alendronate+5600 IU vitamin D combination tablet
1005299|NCT00803790|E3|Reported Event|Vitamin D|Single dose of 5600 IU vitamin D, administered as 2 x 2800 IU tablets
1005300|NCT00803790|E2|Reported Event|Alendronate|Single dose of 70mg alendronate tablet
1005301|NCT00803790|E1|Reported Event|Alendronate+Vitamin D Combo|Single dose of 70 mg alendronate+5600 IU vitamin D combination tablet
1005302|NCT00803777|B1|Baseline|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005303|NCT00803777|P1|Participant Flow|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005304|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005305|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005306|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005307|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005308|NCT00803777|O1|Outcome|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005309|NCT00803777|E1|Reported Event|Intended Users of the Monitoring System|Subjects with type 1 diabetes and healthcare professionals (HCP) used a new blood glucose monitoring system (BGMS) with subject capillary blood. Any subject under age 18 was accompanied by a parent or guardian, who assisted subject if applicable.
1005310|NCT00803751|B3|Baseline|Total|Total of all reporting groups
1005311|NCT00803751|B2|Baseline|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
1005312|NCT00803751|B1|Baseline|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
1005313|NCT00803751|P2|Participant Flow|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
1005314|NCT00803751|P1|Participant Flow|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
1005315|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
1005316|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
1005317|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
1005318|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
1005319|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
1005320|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
1005321|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
1005322|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
1005323|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
1005324|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
1005325|NCT00803751|O2|Outcome|Mac Blade|This groups has data with all the mac blade intubations
1005326|NCT00803751|O1|Outcome|Truview|This group has data for all the truview intubations
1005327|NCT00803751|E2|Reported Event|Macintosh Intubation First Followed by Truview Intubation|Use the Macintosh laryngoscope first immediately followed by laryngoscopy and intubation with the Truview laryngoscope
1005328|NCT00803751|E1|Reported Event|Truview Intubation First Then With Macintosh|Receive laryngoscopy with Truview blade first and is immediately followed by laryngoscopy and intubation with Macintosh blade
1005329|NCT00803738|B3|Baseline|Total|Total of all reporting groups
1005330|NCT00803738|B2|Baseline|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
1005331|NCT00803738|B1|Baseline|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
1005332|NCT00803738|P2|Participant Flow|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
1005333|NCT00803738|P1|Participant Flow|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
1005334|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
1005335|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
1005336|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
1005337|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
1005338|NCT00803738|O2|Outcome|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
1005339|NCT00803738|O1|Outcome|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
1005340|NCT00803738|E2|Reported Event|Terazol 3 - Terconazole Vaginal Suppositories 80 mg|Terazol 3 manufactured by Ortho-McNeil Pharmaceutical, Inc applied intravaginally once daily before bedtime for 3 consecutive daysapplied the study medication intravaginally once daily before bedtime for 3 consecutive days
1005341|NCT00803738|E1|Reported Event|Terconazole Vaginal Suppositories, 80 mg - Perrigo|Terconazole Vaginal Suppositories, 80 mg manufactured by Perrigo applied intravaginally once daily before bedtime for 3 consecutive days
1005342|NCT00803712|B3|Baseline|Total|Total of all reporting groups
1005343|NCT00803712|B2|Baseline|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005344|NCT00803712|B1|Baseline|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005345|NCT00803712|P2|Participant Flow|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005346|NCT00803712|P1|Participant Flow|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005347|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005348|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005349|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005350|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005351|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005352|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005353|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005354|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005355|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005356|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005357|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005358|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005359|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005360|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005361|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005362|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005363|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005364|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005365|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005366|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005367|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005368|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005369|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005370|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005371|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005372|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005373|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005374|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005375|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005376|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005377|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005378|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005379|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005380|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005381|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005382|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005383|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005384|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005385|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005386|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005387|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005388|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005389|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005390|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005391|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005392|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005393|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005394|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005395|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005396|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005397|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005398|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005399|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005400|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005401|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005402|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005403|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005404|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005405|NCT00803712|O2|Outcome|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005406|NCT00803712|O1|Outcome|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005407|NCT00803712|E2|Reported Event|Control Group|Flexible active vitamin D dosing (if prescribed) per standard treatment guidelines.
1005408|NCT00803712|E1|Reported Event|Cinacalcet|cinacalcet in combination with low-dose active vitamin D (if prescribed)
1005409|NCT00803686|B5|Baseline|Total|Total of all reporting groups
1005410|NCT00803686|B4|Baseline|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
1005411|NCT00803686|B3|Baseline|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
1005412|NCT00803686|B2|Baseline|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
1005413|NCT00803686|B1|Baseline|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
1005414|NCT00803686|P4|Participant Flow|Fortical Nasal Spray (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter the open label Part 2, Period 3 and were given Fortical Nasal Spray 2 hours after the evening meal
1005415|NCT00803686|P3|Participant Flow|Oral rsCT Tablets (Part 2, Period 3)|After completing Part 1, Periods 1 and 2, subjects were re-randomized to enter open label Part 2, Period 3, and received oral rsCT tablets given 2 hours after the evening meal.
1005416|NCT00803686|P2|Participant Flow|Oral Placebo|In Part 1, Period 1, 6 Subjects each were given oral placebo tablets 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral rsCT tablets 4 hours after the evening meal.
1005417|NCT00803686|P1|Participant Flow|Oral Recombinant Salmon Calcitonin (rsCT)|In Part 1, Period 1, 6 Subjects each were given rsCT tablets or 4 hours after the evening meal. In Part 1 Period 2, the same subjects were crossed over and given oral placebo 4 hours after the evening meal.
1005418|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
1005419|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
1005420|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
1005421|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
1005422|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|After completing Part 1, subjects were eligible to enter the open-label Part 2. Two dropped out and 4 received Fortical nasal spray 2 hours after the evening meal.
1005423|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|After completing Part 1, subjects were eligible to enter the open-label Part 2. One dropped out and 5 entered and received oral rsCT tablets given 2 hours after the evening meal.
1005424|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
1005425|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
1005426|NCT00803686|O4|Outcome|Part 2 Fortical Intra-nasal Spray|Subjects were given Fortical (rsCT) nasal spray four hours after the evening meal
1005427|NCT00803686|O3|Outcome|Part 2 Oral rsCT Tablets|Subjects were given oral rsCT tablets four hours after the evening meal
1005428|NCT00803686|O2|Outcome|Part 1 Oral Placebo Tablets|In this arm, subjects were given oral placebo tablets 4 hours after the evening meal.
1005429|NCT00803686|O1|Outcome|Part 1 Oral rsCT Tablets|In this arm, Subjects were given oral rsCT tablets 4 hours after the evening meal.
1005430|NCT00803686|E4|Reported Event|Part 2 Open Label Fortical Intranasal Spray|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2,(Period 3) when they received Fortical intra-nasal spray 2 hours after the evening meal
1005431|NCT00803686|E3|Reported Event|Part 2 Open Label--Oral rsCT Tablets|After completing Part 1, Periods 1 and 2, subjects were eligible to participate in the open label Part 2 (Period 3) when oral rsCT tablets were given 2 hours after the evening meal.
1005432|NCT00803686|E2|Reported Event|Part 1 Oral Placebo Tablets|Subjects were given oral placebo tablets 4 hours after the evening meal.
1005433|NCT00803686|E1|Reported Event|Part 1 Oral rsCT Tablets|Subjects were given oral rsCT tablets 4 hours after the evening meal
1005434|NCT00803647|B1|Baseline|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
1005435|NCT00803647|P1|Participant Flow|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
1005436|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
1005437|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
1005438|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
1005439|NCT00803647|O1|Outcome|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
1005440|NCT00803647|E1|Reported Event|Treatment|mFOLFOX7 (5-FU, leucovorin, oxaliplatin) + cetuximab
1005441|NCT00803634|B3|Baseline|Total|Total of all reporting groups
1005442|NCT00803634|B2|Baseline|SOC IV Antihypertensive Therapy|All randomized and eligible patients who received any SOC dose.
1005443|NCT00803634|B1|Baseline|Clevidipine Emulsion|All randomized and eligible patients who received any dose of clevidipine.
1005444|NCT00803634|P2|Participant Flow|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005445|NCT00803634|P1|Participant Flow|Clevidipine|Clevidipine (0.5 mg/mL in 20% lipid emulsion) was administered intravenously via a single dedicated line to all patients randomized to the clevidipine arm. Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005446|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005447|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005448|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005449|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005450|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005451|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005452|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005453|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005454|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005455|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005456|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005457|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005458|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005459|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005460|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005461|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005462|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005463|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005576|NCT00803270|P2|Participant Flow|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and~Behavioral therapy."
1020853|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1005464|NCT00803634|O2|Outcome|SOC IV Therapy|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005465|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005466|NCT00803634|O2|Outcome|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005467|NCT00803634|O1|Outcome|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005468|NCT00803634|E2|Reported Event|Standard of Care|The selection of the standard of care (SOC) IV antihypertensive treatment agent was at the discretion of the investigator. The infusion was administered per the institution's treatment practice. Dose titrations were to be performed to the maximum allowed or tolerated dose in order to achieve SBP control within the patient-specified SBP target range within the first 30 minutes. SOC was to be administered for a minimum of 30 minutes and, if medically warranted, could continue beyond 96 hours at the investigator's discretion.
1005469|NCT00803634|E1|Reported Event|Clevidipine|Clevidipine was titrated to effect thereafter by doubling the dose every 3 minutes, per physician discretion and as tolerated by the patient, until the desired SBP target range was attained. The infusion rate could then be increased or decreased as needed in order to maintain blood pressure for minimum of 30 minutes and a maximum duration of 96 hours. The minimum infusion rate was 1 mg/h and maximum infusion rate was 32 mg/h.
1005470|NCT00803595|B4|Baseline|Total|Total of all reporting groups
1005471|NCT00803595|B3|Baseline|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
1005472|NCT00803595|B2|Baseline|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
1005473|NCT00803595|B1|Baseline|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
1005474|NCT00803595|P3|Participant Flow|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
1005475|NCT00803595|P2|Participant Flow|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
1005476|NCT00803595|P1|Participant Flow|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
1005477|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
1005478|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
1005479|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
1005480|NCT00803595|O3|Outcome|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
1005481|NCT00803595|O2|Outcome|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
1005482|NCT00803595|O1|Outcome|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
1005483|NCT00803595|E3|Reported Event|Oseltamivir 75 mg|oseltamivir phosphate oral capsules
1005484|NCT00803595|E2|Reported Event|CS-8958 Low Dose 20 mg|CS-8958 powder to be inhaled - low-dose arm
1005485|NCT00803595|E1|Reported Event|CS-8958 High Dose 40 mg|CS-8958 powder to be inhaled - high-dose arm
1005486|NCT00803517|B3|Baseline|Total|Total of all reporting groups
1005487|NCT00803517|B2|Baseline|Focal Laser Photocoagulation|
1005488|NCT00803517|B1|Baseline|Photodynamic Therapy|
1005489|NCT00803517|P2|Participant Flow|Focal Laser Photocoagulation|
1005490|NCT00803517|P1|Participant Flow|Photodynamic Therapy|
1005491|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
1005492|NCT00803517|O1|Outcome|Photodynamic Therapy|
1005493|NCT00803517|O2|Outcome|Focal Laser Photocoagulation|
1005494|NCT00803517|O1|Outcome|Photodynamic Therapy|
1005495|NCT00803413|B5|Baseline|Total|Total of all reporting groups
1005496|NCT00803413|B4|Baseline|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
1005497|NCT00803413|B3|Baseline|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
1005498|NCT00803413|B2|Baseline|Supervised Walking|
1005499|NCT00803413|B1|Baseline|Back School|
1005500|NCT00803413|P4|Participant Flow|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
1005577|NCT00803270|P1|Participant Flow|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
1005501|NCT00803413|P3|Participant Flow|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
1005502|NCT00803413|P2|Participant Flow|Supervised Walking|
1005503|NCT00803413|P1|Participant Flow|Back School|
1005504|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
1005505|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
1005506|NCT00803413|O2|Outcome|Supervised Walking|
1005507|NCT00803413|O1|Outcome|Back School|
1005508|NCT00803413|O4|Outcome|Control Group|Once a week for 5 consecutive weeks participants attended sessions of 45 minutes including lectures about: stress control, healthy nutrition (2 lectures), sleep hygiene and injury prevention. This group also received a 2-page folder with print information about LBP prevention and control.
1005509|NCT00803413|O3|Outcome|Backschool and Supervised Walking|Once a week for 5 consecitive weeks participants attended of 90 minutes including: 30-minute lectures about basics of spine’s anatomy, ergonomics, techniques of lifting and transportation of weights and volumes, body posture in several daily tasks and situations, spine preventive care, and about physical activity, its advantages and benefits, barriers and facilitators, types and opportunities; 30 minutes of on-place supervised exercises for posture and spine flexibility (muscle stretching, relaxation, strengthening); 30 minutes of on-place supervised walking in group.
1005510|NCT00803413|O2|Outcome|Supervised Walking|
1005511|NCT00803413|O1|Outcome|Back School|
1005512|NCT00803400|B3|Baseline|Total|Total of all reporting groups
1005513|NCT00803400|B2|Baseline|Alprazolam + Aerobic Exercise|
1005514|NCT00803400|B1|Baseline|Alprazolam|
1005515|NCT00803400|P2|Participant Flow|Alprazolam + Aerobic Exercise|
1005516|NCT00803400|P1|Participant Flow|Alprazolam|
1005517|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
1005518|NCT00803400|O1|Outcome|Alprazolam|
1005519|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
1005520|NCT00803400|O1|Outcome|Alprazolam|
1005521|NCT00803400|O2|Outcome|Alprazolam + Aerobic Exercise|
1005522|NCT00803400|O1|Outcome|Alprazolam|
1005523|NCT00803400|E2|Reported Event|Alprazolam + Aerobic Exercise|
1005524|NCT00803400|E1|Reported Event|Alprazolam|
1005525|NCT00803361|B3|Baseline|Total|Total of all reporting groups
1005526|NCT00803361|B2|Baseline|Placebo|placebo capsules, oral, once a day for 15 weeks
1005527|NCT00803361|B1|Baseline|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005528|NCT00803361|P2|Participant Flow|Placebo|placebo capsules, oral, once a day for 15 weeks
1005529|NCT00803361|P1|Participant Flow|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005530|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
1005531|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005532|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
1005533|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005534|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
1005535|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005536|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
1005537|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005538|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
1005539|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005540|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
1005541|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005542|NCT00803361|O2|Outcome|Placebo|placebo capsules, oral, once a day for 15 weeks
1005543|NCT00803361|O1|Outcome|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005544|NCT00803361|E2|Reported Event|Placebo|placebo capsules, oral, once a day for 15 weeks
1005545|NCT00803361|E1|Reported Event|Duloxetine|60 to 120 mg, capsules, oral, once a day for 15 weeks
1005546|NCT00803283|B3|Baseline|Total|Total of all reporting groups
1005547|NCT00803283|B2|Baseline|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005548|NCT00803283|B1|Baseline|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005549|NCT00803283|P2|Participant Flow|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005578|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
1005550|NCT00803283|P1|Participant Flow|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005551|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005552|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005553|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005554|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005555|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005556|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005557|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005558|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005559|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005560|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005561|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005562|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005563|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005564|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005565|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005566|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005567|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005568|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005569|NCT00803283|O2|Outcome|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005570|NCT00803283|O1|Outcome|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005571|NCT00803283|E2|Reported Event|Morphine Sustain Release (SR)|Participants received morphine SR 8 mg every 24 hours, for Day 3 to14 of titration phase. Morphine SR was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005572|NCT00803283|E1|Reported Event|Hydromorphone Hydrochloride (HCl) Oral Osmotic System (OROS)|Participants received hydromorphone HCl OROS 8 milligram (mg) every 24 hours, for 3 to 14 days of titration phase. Hydromorphone HCl OROS was continued as per Investigator’s discretion for next 14 days of maintenance phase.
1005573|NCT00803270|B3|Baseline|Total|Total of all reporting groups
1005574|NCT00803270|B2|Baseline|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
1005575|NCT00803270|B1|Baseline|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
1005629|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005579|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
1005580|NCT00803270|O2|Outcome|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
1005581|NCT00803270|O1|Outcome|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
1005582|NCT00803270|E2|Reported Event|Non Surgical Treatment|"The non-surgical treatment will include two components:~Pharmacological therapy with any FDA approved OAB drug in approved doses; and~Behavioral therapy."
1005583|NCT00803270|E1|Reported Event|Surgical Treatment|Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension.
1005584|NCT00803244|B3|Baseline|Total|Total of all reporting groups
1005585|NCT00803244|B2|Baseline|Placebo|Placebo tablet
1005586|NCT00803244|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
1005587|NCT00803244|P2|Participant Flow|Placebo|Placebo tablet
1005588|NCT00803244|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
1005589|NCT00803244|O2|Outcome|Placebo|Placebo tablet
1005590|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
1005591|NCT00803244|O2|Outcome|Placebo|Placebo tablet
1005592|NCT00803244|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
1005593|NCT00803244|E2|Reported Event|Placebo|Placebo tablet
1005594|NCT00803244|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
1005595|NCT00803179|B1|Baseline|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
1005596|NCT00803179|P1|Participant Flow|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
1005597|NCT00803179|O1|Outcome|Growth Hormone Therapy|"Nutropin Aqueous (AQ):~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
1005598|NCT00803179|E1|Reported Event|Growth Hormone Therapy|"Nutropin AQ:~Initiation treatment for adult males is 0.2mg/d and for women 0.4mg/d"
1005599|NCT00803114|B3|Baseline|Total|Total of all reporting groups
1005600|NCT00803114|B2|Baseline|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
1005601|NCT00803114|B1|Baseline|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
1005602|NCT00803114|P2|Participant Flow|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
1005603|NCT00803114|P1|Participant Flow|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
1005604|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
1005605|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
1005606|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
1005607|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
1005608|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
1005609|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
1005610|NCT00803114|O2|Outcome|Placebo|5 ml of epidural preservative-free saline given within one hour following vaginal delivery
1005611|NCT00803114|O1|Outcome|Epidural Morphine|2.5 mg dose of epidural morphine given within one hour following vaginal delivery
1005612|NCT00803101|B3|Baseline|Total|Total of all reporting groups
1005613|NCT00803101|B2|Baseline|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005614|NCT00803101|B1|Baseline|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005615|NCT00803101|P2|Participant Flow|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005616|NCT00803101|P1|Participant Flow|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline international normalized ratio (INR), amount of coagulation factor IX and body-weight.
1005617|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005618|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005619|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005620|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005621|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005622|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005623|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005624|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005625|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005626|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005627|NCT00803101|O2|Outcome|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005628|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005630|NCT00803101|O1|Outcome|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005631|NCT00803101|E2|Reported Event|Fresh Frozen Plasma|Fresh frozen plasma: Intravenous infusion, dosage depending on baseline INR and body weight
1005632|NCT00803101|E1|Reported Event|Beriplex® P/N|Beriplex® P/N: Intravenous infusion, dosage depending on baseline INR, amount of coagulation factor IX and body-weight.
1005633|NCT00803062|B5|Baseline|Total|Total of all reporting groups
1005634|NCT00803062|B4|Baseline|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005635|NCT00803062|B3|Baseline|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
1005636|NCT00803062|B2|Baseline|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005637|NCT00803062|B1|Baseline|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
1005638|NCT00803062|P4|Participant Flow|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005639|NCT00803062|P3|Participant Flow|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
1005640|NCT00803062|P2|Participant Flow|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005641|NCT00803062|P1|Participant Flow|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
1005642|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005643|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
1005644|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005645|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
1005646|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005647|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
1005648|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005649|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
1005650|NCT00803062|O4|Outcome|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005651|NCT00803062|O3|Outcome|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
1005652|NCT00803062|O2|Outcome|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005653|NCT00803062|O1|Outcome|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
1005654|NCT00803062|E4|Reported Event|Arm IV (Topotecan Hydrochloride, Paclitaxel, Bevacizumab)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005655|NCT00803062|E3|Reported Event|Arm III (Topotecan Hydrochloride and Paclitaxel)|Paclitaxel 175 mg/m2 over 3 hrs on day 1 Topotecan 0.75 mg/m2 over 30 mins days 1-3 Cycles repeated q21 days to progression/toxicity
1005656|NCT00803062|E2|Reported Event|Arm II (Paclitaxel, Cisplatin, Bevacizumab)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 Bevacizumab 15 mg/kg IV day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Bevacizumab 15 mg/kg IV day 1 Cycles repeated q21 days to progression/toxicity
1005657|NCT00803062|E1|Reported Event|Arm I (Paclitaxel and Cisplatin)|Paclitaxel 135 mg/m2 IV over 24 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 2 OR Paclitaxel 175 mg/m2 IV over 3 hrs on day 1 Cisplatin 50 mg/m2 IV on day 1 Cycles repeated q21 days to progression/toxicity
1005658|NCT00803049|B5|Baseline|Total|Total of all reporting groups
1005659|NCT00803049|B4|Baseline|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005660|NCT00803049|B3|Baseline|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005661|NCT00803049|B2|Baseline|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005662|NCT00803049|B1|Baseline|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005663|NCT00803049|P4|Participant Flow|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005664|NCT00803049|P3|Participant Flow|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005665|NCT00803049|P2|Participant Flow|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005666|NCT00803049|P1|Participant Flow|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet once daily (QD) for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005667|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005668|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005669|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005670|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005671|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005672|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005673|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005674|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005675|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005676|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005677|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005678|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005679|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005680|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005681|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005682|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005683|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005684|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005685|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005686|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005687|NCT00803049|O4|Outcome|Teriflunomide 14 mg/14 mg|Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005688|NCT00803049|O3|Outcome|Placebo/Teriflunomide 14 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.
1005689|NCT00803049|O2|Outcome|Teriflunomide 7 mg/7 mg|Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.
1005690|NCT00803049|O1|Outcome|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005691|NCT00803049|E4|Reported Event|Teriflunomide 14 mg/14 mg|"Participants who completed treatment of teriflunomide 14 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in 14 mg arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received correct dose of 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
1005692|NCT00803049|E3|Reported Event|Placebo/Teriflunomide 14 mg|"Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049, study received teriflunomide 14 mg tablet QD for 288 weeks in this extension study.~Excluded 1 participant randomized in placebo arm in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participant received 14 mg dose but included in teriflunomide 7 mg/7 mg arm for safety analysis."
1005693|NCT00803049|E2|Reported Event|Teriflunomide 7 mg/7 mg|"Participants who completed treatment of teriflunomide 7 mg tablet QD for 108 weeks in EFC6049 study, continued their treatment with teriflunomide 7 mg tablet QD for 288 weeks in this extension study.~Included 2 participants randomized in placebo and teriflunomide 14 mg arm respectively in EFC6049 study, incorrectly received at least 1 dose of teriflunomide 7 mg. In LTS6050 study, same participants received correct dose of teriflunomide 14 mg but included in Teriflunomide 7mg/7 mg arm for safety analysis."
1005694|NCT00803049|E1|Reported Event|Placebo/Teriflunomide 7 mg|Participants who completed treatment of placebo (for teriflunomide) tablet QD for 108 weeks in EFC6049 study, received teriflunomide tablet 7 mg QD for 288 weeks in this extension study.
1005695|NCT00803023|B5|Baseline|Total|Total of all reporting groups
1005696|NCT00803023|B4|Baseline|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
1005697|NCT00803023|B3|Baseline|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
1005698|NCT00803023|B2|Baseline|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
1005699|NCT00803023|B1|Baseline|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
1005700|NCT00803023|P4|Participant Flow|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
1005701|NCT00803023|P3|Participant Flow|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
1005702|NCT00803023|P2|Participant Flow|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
1005703|NCT00803023|P1|Participant Flow|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
1005704|NCT00803023|O4|Outcome|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
1005705|NCT00803023|O3|Outcome|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
1005706|NCT00803023|O2|Outcome|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
1005707|NCT00803023|O1|Outcome|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
1005708|NCT00803023|E4|Reported Event|6g SXB + 8 Tablets|Sodium Oxybate Oral Solution (6 grams/night) and 8 Placebo Tablets per night
1005709|NCT00803023|E3|Reported Event|6g SXB|Sodium Oxybate Oral Solution (6 grams/night)
1005710|NCT00803023|E2|Reported Event|4.5g SXB + 6 Tablets|Sodium Oxybate Oral Solution (4.5 grams/night)and 6 Placebo Tablets per night
1005711|NCT00803023|E1|Reported Event|4.5g SXB|Sodium Oxybate Oral Solution (4.5 grams/night)
1005712|NCT00803010|B3|Baseline|Total|Total of all reporting groups
1005713|NCT00803010|B2|Baseline|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
1005714|NCT00803010|B1|Baseline|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
1005715|NCT00803010|P2|Participant Flow|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
1005716|NCT00803010|P1|Participant Flow|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
1006302|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1005717|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
1005718|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
1005719|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
1005720|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
1005721|NCT00803010|O2|Outcome|2 Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus and Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
1005722|NCT00803010|O1|Outcome|1 Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus and Rapamycin (Sirolimus): Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
1005723|NCT00803010|E2|Reported Event|Tacrolimus / Methotrexate|"Tacrolimus / Methotrexate~Tacrolimus / Methotrexate: Tacrolimus administered at 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3~Methotrexate: administered on day 1 at dose of 15 mg/m^2, and a dose of 10 mg/m^2 on days 3, 6, and 11. Dose can be adjusted for reduced creatinine clearance."
1005724|NCT00803010|E1|Reported Event|Tacrolimus / Rapamycin|"Tacrolimus / Rapamycin~Tacrolimus / Rapamycin: Tacrolimus - 0.02 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3.~Rapamycin - initially as 9 mg oral loading dose on day -1. Thereafter, administered as an oral regimen of 4 mg daily."
1005725|NCT00802997|B3|Baseline|Total|Total of all reporting groups
1005726|NCT00802997|B2|Baseline|Sham Procedure|
1005727|NCT00802997|B1|Baseline|Lateral Branch Neurotomy|
1005728|NCT00802997|P2|Participant Flow|Sham Procedure|The sham procedure was identical to the active treatment procedure but without the delivery of radiofrequency energy. The sham procedure was completed one time within 60 days of enrollment.
1005729|NCT00802997|P1|Participant Flow|Lateral Branch Neurotomy|The lateral branch neurotomy procedure involved the ablation of the S1-S3 lateral branches and the L5 dorsal ramus using cooled radiofrequency electrodes. The procedure was completed one time within 60 days of enrollment.
1005730|NCT00802997|O2|Outcome|Sham Procedure|
1005731|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
1005732|NCT00802997|O2|Outcome|Sham Procedure|
1005733|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
1005734|NCT00802997|O2|Outcome|Sham Procedure|
1005735|NCT00802997|O1|Outcome|Lateral Branch Neurotomy|
1005736|NCT00802997|E2|Reported Event|Sham Procedure|
1005737|NCT00802997|E1|Reported Event|Lateral Branch Neurotomy|
1005738|NCT00802880|B1|Baseline|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005739|NCT00802880|P1|Participant Flow|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005740|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005741|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005742|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005743|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005744|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005745|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005746|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005747|NCT00802880|O4|Outcome|Total|
1005748|NCT00802880|O3|Outcome|Progressive Metabolic Disease|
1005749|NCT00802880|O2|Outcome|Stable Metabolic Disease|
1005750|NCT00802880|O1|Outcome|Partial Metabolic Response|
1005751|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005752|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005753|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005754|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005755|NCT00802880|O1|Outcome|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005756|NCT00802880|E1|Reported Event|Dacarbazine|Dacarbazine 850 mg/m^2 IV Day 1 of each 21 day cycle.
1005757|NCT00802867|B1|Baseline|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1005758|NCT00802867|P1|Participant Flow|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1005759|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1005760|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1005761|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1007086|NCT00798161|B4|Baseline|Lina5|Patients treated with Linagliptin 5mg OD
1005762|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1005763|NCT00802867|O1|Outcome|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1005764|NCT00802867|E1|Reported Event|DAPTACEL® Vaccine Group|Participants received DAPTACEL® as the 5th dose after 4 doses of Pentacel® in Study 494-01 or Study 494-03.
1005765|NCT00802841|B3|Baseline|Total|Total of all reporting groups
1005766|NCT00802841|B2|Baseline|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005767|NCT00802841|B1|Baseline|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005768|NCT00802841|P2|Participant Flow|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005769|NCT00802841|P1|Participant Flow|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005770|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005771|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005772|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005773|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005774|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005775|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005776|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005777|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005778|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005779|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005780|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005781|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005782|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005783|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005784|NCT00802841|O2|Outcome|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005785|NCT00802841|O1|Outcome|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005786|NCT00802841|E4|Reported Event|Cross-over to Imatinib|600 mg QD
1005787|NCT00802841|E3|Reported Event|Cross-over to Nilotinib|Nilotinib 400 mg BID
1005788|NCT00802841|E2|Reported Event|Imatinib|Participants receievd 600 mg imatinib once daily (QD).
1005789|NCT00802841|E1|Reported Event|Nilotinib|Participants received 400 mg nilotinib twice daily (BID).
1005790|NCT00802737|B4|Baseline|Total|Total of all reporting groups
1005791|NCT00802737|B3|Baseline|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005792|NCT00802737|B2|Baseline|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005793|NCT00802737|B1|Baseline|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005794|NCT00802737|P3|Participant Flow|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005795|NCT00802737|P2|Participant Flow|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1007087|NCT00798161|B3|Baseline|M1000BID|Patients treated with Metformin 1000mg BID
1005796|NCT00802737|P1|Participant Flow|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005797|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
1005798|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005799|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005800|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005801|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005802|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005803|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005804|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005805|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005906|NCT00802633|B1|Baseline|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
1020854|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1005806|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005807|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005808|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005809|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005810|NCT00802737|O4|Outcome|Total|This arm includes a total of all three arms combined.
1005811|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005812|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005813|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005814|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005815|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005907|NCT00802633|P2|Participant Flow|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
1005816|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005817|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005818|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005819|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005820|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005821|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005822|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005823|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005824|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005908|NCT00802633|P1|Participant Flow|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
1006198|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
1005825|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005826|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005827|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005828|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005829|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005830|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005831|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005832|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005833|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005909|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
1006199|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
1005834|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005835|NCT00802737|O3|Outcome|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005836|NCT00802737|O2|Outcome|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005837|NCT00802737|O1|Outcome|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005838|NCT00802737|E3|Reported Event|2000 mg Ofatumumab + Other|"Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up (Months 29-44). These participants were classified as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62)."
1005839|NCT00802737|E2|Reported Event|2000 mg Ofatumumab + BFR|Participants who had responded to ofatumumab or had stable disease in Hx-CD20-406 and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy. Par. with disease progression entered into the Extended Follow-up phase (Months 47 to 62).
1005840|NCT00802737|E1|Reported Event|2000 mg Ofatumumab + DR|Participants (Par.) who had responded to ofatumumab or had stable disease in Hx-CD20-406 (Study OMB111773; NCT00349349) and then progressed were offered retreatment and maintenance. For retreatment, ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions. For the maintenance of responders, participants received 24 monthly infusions of 2000 mg for up to 24 months, for a total duration of treatment of up to 26 months after which, if possible, the par. entered the Follow-up phase (Months 29-44). These participants were classified as double refractory (DR), defined as participants who were enrolled in Study Hx-CD20-406 and were refractory to both fludarabine and alemtuzumab. Par. with disease progression entered the Extended Follow-up phase (Months 47 to 62).
1005841|NCT00802685|B3|Baseline|Total|Total of all reporting groups
1005842|NCT00802685|B2|Baseline|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
1005881|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005882|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005843|NCT00802685|B1|Baseline|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
1005844|NCT00802685|P2|Participant Flow|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
1005845|NCT00802685|P1|Participant Flow|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
1005846|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
1005847|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
1005848|NCT00802685|O2|Outcome|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
1005849|NCT00802685|O1|Outcome|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
1005883|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005910|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
1005850|NCT00802685|E2|Reported Event|Late Ibuprofen Expectant Group|"Drug: Late ibuprofen expectant group~IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to late ibuprofen expectant group will receive blinded placebo. If criteria of a hemodynamically significant PDA develop, infants from this group can now receive open label ibuprofen at an initial dose of 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Signs of a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV. Infants who had received placebo will be have ibuprofen for the first time (thus, late ibuprofen or expectant).~Late ibuprofen expectant group : Other: Late Ibuprofen expectant"
1005851|NCT00802685|E1|Reported Event|Early Ibuprofen|"Drug: Early ibuprofen IBUPROFEN DOSING SCHEDULE: At the diagnosis of PDA, infants randomized to early treatment will receive blinded ibuprofen initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. This group will then be eligible to receive unblended, open label ibuprofen for a hemodynamically significant PDA include: SIGNS OF PDA + Presence of significant pulmonary hemorrhage ALONE OR SIGNS OF PDA +: Pulmonary edema, plus a large heart on CXR + one of the following: Hypotension, Respiratory failure (not due to something other than PDA) defined as at least two of the following respirator settings: Need for supplemental O2 > 50%; need IMV >40; need for PIP > 20; or need for HFOV.~Early ibuprofen : IBUPROFEN DOSING SCHEDULE: initial dose 10 mg/kg, then two doses 5 mg/kg each, after 24 and 48 h, slow IV infusion. Initial therapy will be blinded. At the diagnosis of PDA, infants randomized to early treatment w"
1005852|NCT00802672|B4|Baseline|Total|Total of all reporting groups
1005853|NCT00802672|B3|Baseline|Vehicle Product|placebo
1005854|NCT00802672|B2|Baseline|Reference Product|Loprox Cream
1005855|NCT00802672|B1|Baseline|Test Product|Ciclopirox cream
1005856|NCT00802672|P3|Participant Flow|Vehicle Product|placebo
1005857|NCT00802672|P2|Participant Flow|Reference Product|Loprox Cream
1005858|NCT00802672|P1|Participant Flow|Test Product|Ciclopirox cream
1005859|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
1005860|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
1005861|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
1005862|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
1005863|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
1005864|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
1005865|NCT00802672|O3|Outcome|Vehicle Product|Vehicle
1005866|NCT00802672|O2|Outcome|Reference Product|Loprox® (ciclopirox) Cream 0.77%
1005867|NCT00802672|O1|Outcome|Test Product|Ciclopirox Olamine Cream, USP
1005868|NCT00802672|E3|Reported Event|Vehicle Product|Vehicle
1005869|NCT00802672|E2|Reported Event|Reference Product|Loprox® (ciclopirox) Cream 0.77%
1005870|NCT00802672|E1|Reported Event|Test Product|Ciclopirox Olamine Cream, USP
1005871|NCT00802659|B5|Baseline|Total|Total of all reporting groups
1005872|NCT00802659|B4|Baseline|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005873|NCT00802659|B3|Baseline|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005874|NCT00802659|B2|Baseline|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005875|NCT00802659|B1|Baseline|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005876|NCT00802659|P4|Participant Flow|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005877|NCT00802659|P3|Participant Flow|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005878|NCT00802659|P2|Participant Flow|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005879|NCT00802659|P1|Participant Flow|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005880|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005904|NCT00802633|B3|Baseline|Total|Total of all reporting groups
1005905|NCT00802633|B2|Baseline|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
1005884|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005885|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005886|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005887|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005888|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005889|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005890|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005891|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005892|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005893|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005894|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005895|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005896|NCT00802659|O4|Outcome|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005897|NCT00802659|O3|Outcome|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005898|NCT00802659|O2|Outcome|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005899|NCT00802659|O1|Outcome|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005900|NCT00802659|E4|Reported Event|Group 3|"1600 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005901|NCT00802659|E3|Reported Event|Group 2|"1400 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005902|NCT00802659|E2|Reported Event|Group 1|"1200 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005903|NCT00802659|E1|Reported Event|Group -1|"1000 cGY radiation~Stereotactic radiotherapy: This study has 4 treatment groups: This will be determined based on what radiation treatment doses have been previously given to the patient on this study, how effective the dose has been with treatment of patient's pain, and how many side effects participants before have experienced."
1005911|NCT00802633|O2|Outcome|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
1005912|NCT00802633|O1|Outcome|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
1005913|NCT00802633|E2|Reported Event|Ligasure Device|"Efficacy of ligasure tissue sealing device during radical cystectomy~Ligasure tissue sealing device: Efficacy of tissue sealing device during hemostasis"
1005914|NCT00802633|E1|Reported Event|Stapling Device|"Efficacy of stapling device during radical cystectomy~Stapling device during radical cystectomy: Hemostasis"
1005915|NCT00802529|B3|Baseline|Total|Total of all reporting groups
1005916|NCT00802529|B2|Baseline|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
1005917|NCT00802529|B1|Baseline|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
1005918|NCT00802529|P2|Participant Flow|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.Each injection was 40mg/ml.
1005919|NCT00802529|P1|Participant Flow|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks. Each injection was 62.5mg/ml.
1005920|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
1005921|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
1005922|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
1005923|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
1005924|NCT00802529|O2|Outcome|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
1005925|NCT00802529|O1|Outcome|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
1005926|NCT00802529|E2|Reported Event|Gentamicin|Gentamicin: 2 transtympanic injections at an interval of two weeks. If there is significant hearing loss before second injection, it will be replaced by normal saline in double blinded fashion.
1005927|NCT00802529|E1|Reported Event|Steroid (Methylprednisolone)|Methylprednisolone: 2 transtympanic injections at interval of two weeks.
1005928|NCT00802503|B3|Baseline|Total|Total of all reporting groups
1005929|NCT00802503|B2|Baseline|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005930|NCT00802503|B1|Baseline|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
1005931|NCT00802503|P2|Participant Flow|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005932|NCT00802503|P1|Participant Flow|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
1005933|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005934|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
1005935|NCT00802503|O2|Outcome|SPN gr|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005936|NCT00802503|O1|Outcome|Controle gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1006047|NCT00802100|B2|Baseline|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
1005937|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005938|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1005939|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005940|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1005941|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005942|NCT00802503|O1|Outcome|Control Group|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1005943|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005944|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1005945|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005946|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1005947|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005948|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1005949|NCT00802503|O2|Outcome|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005950|NCT00802503|O1|Outcome|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day 1: 500 ml, day 2: 1000 ml, day 3: 1500 ml of EN dependent on gastrointestinal tolerance (gastric residue volume more than 500 ml). Nutritional products as currently used in our institution.
1005951|NCT00802503|E2|Reported Event|SPN Group|"experimental arm: Supplemental Parenteral Nutrition (SPN) is added to enteral nutrition (EN) to reach 100% of their predicted energy needs from ICU day 4.~In the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line. Nutritional products as currently used in our institution. SPN is composed of EN and PN, both techniques being currently used in our institution.~SPN : SPN : in the treated group, SPN is started if at day 4 energy input by EN is < 60% of energy target in order to reach 100% of energy target by peripheral or central line."
1005952|NCT00802503|E1|Reported Event|Control gr|EN : start EN at 20-30 ml/h per day up to maximal 150 ml/h per day; or day1: 500 ml, day2: 1000 ml, day3: 1500 ml of EN dependant on gastrointestinal tolerance (gastric residue volume more than 500ml). Nutritional products as currently used in our institution.
1005953|NCT00802412|B3|Baseline|Total|Total of all reporting groups
1005954|NCT00802412|B2|Baseline|Placebo|Received placebo
1005955|NCT00802412|B1|Baseline|Topiramate|Received active topiramate
1005956|NCT00802412|P2|Participant Flow|Placebo|"90 participants, will receive matching placebo~Placebo: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design."
1005957|NCT00802412|P1|Participant Flow|Topiramate|"The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group.~Topiramate: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days)."
1005958|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
1005959|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
1005960|NCT00802412|O2|Outcome|Placebo|12 weeks of placebo plus behavioral smoking cessation treatment, with 24 week follow up.
1005961|NCT00802412|O1|Outcome|Topiramate|12 weeks of topiramate (up to 200 mg/day) plus smoking cessation treatment, with 24-week follow up.
1005962|NCT00802412|E2|Reported Event|Placebo|
1005963|NCT00802412|E1|Reported Event|Topiramate|
1005964|NCT00802360|B5|Baseline|Total|Total of all reporting groups
1005965|NCT00802360|B4|Baseline|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005966|NCT00802360|B3|Baseline|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005967|NCT00802360|B2|Baseline|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005968|NCT00802360|B1|Baseline|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005969|NCT00802360|P4|Participant Flow|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005970|NCT00802360|P3|Participant Flow|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005971|NCT00802360|P2|Participant Flow|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005972|NCT00802360|P1|Participant Flow|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005973|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005974|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1020855|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1005975|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005976|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005977|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005978|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005979|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005980|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005981|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005982|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005983|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005984|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005985|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005986|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005987|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005988|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005989|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005990|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005991|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005992|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005993|NCT00802360|O4|Outcome|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005994|NCT00802360|O3|Outcome|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005995|NCT00802360|O2|Outcome|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005996|NCT00802360|O1|Outcome|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1005997|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1005998|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1005999|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006000|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006001|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006002|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006003|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006004|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006048|NCT00802100|B1|Baseline|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
1006005|NCT00802360|O2|Outcome|Follistim|"Follitropin beta (Follistim®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Follistim for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006006|NCT00802360|O1|Outcome|Menopur|"Highly purified menotropin (Menopur) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~This group combines the two treatment arms that use Menopur for ovarian stimulation. This treatment is followed by luteal support using either progesterone vaginal insert (Endometrin®) or progesterone in oil."
1006007|NCT00802360|E4|Reported Event|Follistim/Progesterone in Oil|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1006008|NCT00802360|E3|Reported Event|Follistim/Endometrin|"Follitropin beta (Follistim®) 225 IU (up to 450 IU) by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1006009|NCT00802360|E2|Reported Event|Menopur/Progesterone in Oil|"Highly purified menotropin 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone in oil injections 50 mg by intramuscular injection (IM) once per day start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1006010|NCT00802360|E1|Reported Event|Menopur/Endometrin|"Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.~Progesterone vaginal insert (Endometrin®) 100 mg inserted vaginally 2 or 3 times daily (BID or TID) starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained."
1006011|NCT00802204|B3|Baseline|Total|Total of all reporting groups
1006012|NCT00802204|B2|Baseline|Obese|
1006013|NCT00802204|B1|Baseline|Lean|
1006014|NCT00802204|P2|Participant Flow|Obese|BMI>/=30kg/m2
1006015|NCT00802204|P1|Participant Flow|Lean|BMI<~25kg/m2
1006016|NCT00802204|O2|Outcome|Obese|
1006017|NCT00802204|O1|Outcome|Lean|
1006018|NCT00802204|O3|Outcome|Obese Post-diet|
1006019|NCT00802204|O2|Outcome|Obese Baseline|
1006020|NCT00802204|O1|Outcome|Lean Baseline|
1006021|NCT00802204|O3|Outcome|Obese Post-diet|
1006022|NCT00802204|O2|Outcome|Obese Baseline|
1006023|NCT00802204|O1|Outcome|Lean Baseline|
1006024|NCT00802204|O3|Outcome|Obese Post-diet|
1006025|NCT00802204|O2|Outcome|Obese Baseline|
1006026|NCT00802204|O1|Outcome|Lean Baseline|
1006027|NCT00802204|O3|Outcome|Obese Post-diet|
1006028|NCT00802204|O2|Outcome|Obese Baseline|
1006029|NCT00802204|O1|Outcome|Lean Baseline|
1006030|NCT00802204|O3|Outcome|Obese Post-diet|
1006031|NCT00802204|O2|Outcome|Obese Baseline|
1006032|NCT00802204|O1|Outcome|Lean Baseline|
1006033|NCT00802204|O3|Outcome|Obese Post-diet|
1006034|NCT00802204|O2|Outcome|Obese Baseline|
1006035|NCT00802204|O1|Outcome|Lean Baseline|
1006036|NCT00802204|E2|Reported Event|Obese|
1006037|NCT00802204|E1|Reported Event|Lean|
1006038|NCT00802178|B1|Baseline|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
1006039|NCT00802178|P1|Participant Flow|Mirapexin® (Pramipexole)|"The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics.~mode of administration (admin.): Tablets for oral use"
1006040|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
1006041|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
1006042|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
1006043|NCT00802178|O1|Outcome|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
1006044|NCT00802178|E1|Reported Event|Mirapexin® (Pramipexole)|The dose of Mirapexin® was selected by the neurologist upon his/her clinical judgement based on individual patient need and on recommendations given in the Mirapexin® Summary of Product Characteristics. mode of admin.: Tablets for oral use.
1006045|NCT00802100|B4|Baseline|Total|Total of all reporting groups
1006046|NCT00802100|B3|Baseline|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
1006101|NCT00802074|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
1006049|NCT00802100|P3|Participant Flow|Aripiprazole|"Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.~Aripiprazole dose 10-30 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
1006050|NCT00802100|P2|Participant Flow|Perphenazine|"Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.~Perphenazine dose 8-24 mg/day Benztropine dose 1-2 mg/day Metformin dose 850-2550 mg/day Simvistatin dose 20-40 mg/day"
1006051|NCT00802100|P1|Participant Flow|Olanzapine|"Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.~Olanzapine dose 10-30 mg/day Metformin dose 850-2550 mg/day"
1006052|NCT00802100|O3|Outcome|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
1006053|NCT00802100|O2|Outcome|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
1006054|NCT00802100|O1|Outcome|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
1006055|NCT00802100|O1|Outcome|Overall Study|This refers to the feasibility of the entire pilot study. Only 21 eligible participants of the goal of 60 were randomized because sites were unable to identify adequate numbers of eligible participants.
1006056|NCT00802100|E3|Reported Event|Aripiprazole|Participants will receive treatment with aripiprazole, with the possible addition of simvastatin, metformin, or benztropine, depending on side effects.
1006057|NCT00802100|E2|Reported Event|Perphenazine|Participants will receive treatment with perphenazine and benztropine, with the possible addition of simvastatin or metformin, depending on side effects.
1006058|NCT00802100|E1|Reported Event|Olanzapine|Participants will receive treatment with olanzapine and metformin, with the possible addition of simvastatin or benztropine, depending on side effects.
1006059|NCT00802074|B7|Baseline|Total|Total of all reporting groups
1006060|NCT00802074|B6|Baseline|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006061|NCT00802074|B5|Baseline|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006062|NCT00802074|B4|Baseline|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006063|NCT00802074|B3|Baseline|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006064|NCT00802074|B2|Baseline|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006065|NCT00802074|B1|Baseline|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006066|NCT00802074|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1006067|NCT00802074|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
1006068|NCT00802074|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1006069|NCT00802074|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
1006070|NCT00802074|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
1006071|NCT00802074|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID
1006072|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1006073|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1006074|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
1006075|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1006076|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1006102|NCT00801983|B3|Baseline|Total|Total of all reporting groups
1020856|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1006077|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
1006078|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1006079|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1006080|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
1006081|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1006082|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1006083|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
1006084|NCT00802074|O6|Outcome|Group F|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006085|NCT00802074|O5|Outcome|Group E|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006086|NCT00802074|O4|Outcome|Group D|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006087|NCT00802074|O3|Outcome|Group C|"Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006088|NCT00802074|O2|Outcome|Group B|"Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006089|NCT00802074|O1|Outcome|Group A|"Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Raltegravir: 400mg BID~Fosamprenavir: 1400mg BID, 700 mg BID or 1400 mg QD"
1006090|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1006091|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1006092|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
1006093|NCT00802074|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
1006094|NCT00802074|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
1006095|NCT00802074|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg BID Period 3- Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID"
1006096|NCT00802074|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
1006097|NCT00802074|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3- Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
1006098|NCT00802074|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
1006099|NCT00802074|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period2- Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
1006100|NCT00802074|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3 Fosamprenavir 1400mg BID
1006303|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006103|NCT00801983|B2|Baseline|Group B|Subject receives alternative keyboard first (0-6 months) and typical keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
1006104|NCT00801983|B1|Baseline|Group A|Subject receives typical keyboard first (0-6 months) and alternative keyboard second (7-12 months). In this crossover design all subjects received both standard and alternative keyboard, each group just received the keyboards in a different order
1006105|NCT00801983|P2|Participant Flow|Group B (Alternative/Typical)|Subject receives alternate keyboard for 5-6 months first and typical keyboard second for 5-6 months (total 12 months in study
1006106|NCT00801983|P1|Participant Flow|Group A (Typical/Alternative)|Subject receives typical keyboard for 5-6 months first and alternative keyboard second for 5-6 months (total 12 months in study
1006107|NCT00801983|O2|Outcome|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
1006108|NCT00801983|O1|Outcome|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
1006109|NCT00801983|E2|Reported Event|Alternative Keyboard|MSD reported when a subject was typing on an alternative keyboard (regardless of order)
1006110|NCT00801983|E1|Reported Event|Typical Keyboard|MSD reported when a subject was typing on a typical keyboard (regardless of order)
1006111|NCT00801892|B3|Baseline|Total|Total of all reporting groups
1006112|NCT00801892|B2|Baseline|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006113|NCT00801892|B1|Baseline|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006114|NCT00801892|P2|Participant Flow|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006115|NCT00801892|P1|Participant Flow|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006116|NCT00801892|O2|Outcome|2=Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006117|NCT00801892|O1|Outcome|1=Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006118|NCT00801892|E2|Reported Event|2 = Subjects With T2DM and OSA Who Are Treated With Sham-CPAP|"subjects with T2DM and OSA who are treated with sham-CPAP~Sham- Continuous Positive Airway Pressure (Sham-CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006119|NCT00801892|E1|Reported Event|1 Subjects With T2DM and OSA Who Are Treated With CPAP|"subjects with T2DM and OSA who are treated with CPAP~Continuous Positive Airway Pressure (CPAP): Worn over nose to splint open the airway and prevent the subject from holding their breath (apneas)."
1006120|NCT00801827|B1|Baseline|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
1006121|NCT00801827|P1|Participant Flow|Surgical|Patients approved for RYGB or VSG surgery for weight loss at Vanderbilt University Medical Center were recruited.
1006122|NCT00801827|O1|Outcome|F-18 (Fallypride)|Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
1006123|NCT00801827|E1|Reported Event|F-18 (Fallypride)|"Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2 (DA D2) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.~F-18 (fallypride): Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation."
1006124|NCT00801801|B1|Baseline|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
1006125|NCT00801801|P1|Participant Flow|Metronomic Taxotere and Nexavar|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.~Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle. Tumor response to treatment will be evaluated after every 8 weeks. Treatment with metronomic chemotherapy and sorafenib will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity, or withdrawal of consent. Maintenance therapy with sorafenib will then continue until disease progression, intolerable toxicity or withdrawal of consent."
1006126|NCT00801801|O1|Outcome|Metronomic Docetaxel + Sorafenib|"Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.~Subjects will be treated with metronomic chemotherapy with low dose docetaxel weekly for 3 out of 4 weeks, and sorafenib will be administered continuously 400 mg bid on a 28 day cycle. Treatment with metronomic chemotherapy will be expressed as a 4-week cycle."
1006127|NCT00801801|O1|Outcome|Metronomic Taxotere + Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
1006500|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
1006128|NCT00801801|E1|Reported Event|Metronomic Taxotere and Nexavar|Subjects with advanced non-squamous cell non-small cell lung cancer with poor performance status will receive treatment in this non-randomized, open-label Phase II Study of Metronomic Chemotherapy (docetaxel) plus sorafenib as first-line therapy.
1006129|NCT00801684|B1|Baseline|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
1006130|NCT00801684|P1|Participant Flow|Overall Study|"Following screening, each subject was randomized to a sequence of 5 dosing periods (Doses A, B, C, D, and E). Each period was separated by a 3- to 14-day washout interval. Doses A, B, C, and D were administered in a double-blind fashion. Dose E was administered in an open-label fashion.~The dosing formulations were as follows:~Dose A = placebo Dose B = TrIP-2D (100 μg TrCl formulated in leucine and DPPC) Dose C = TrIP-2SS (100 μg TrCl formulated in leucine and sodium saccharin) Dose D = TrIP-2D (400 μg TrCl) Dose E = TrIP-2SS (100 μg TrCl) + Foradil (12 μg formoterol fumarate)"
1006131|NCT00801684|O4|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006132|NCT00801684|O3|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
1006133|NCT00801684|O2|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006134|NCT00801684|O1|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
1006135|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
1006136|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
1006137|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
1006138|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006139|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006140|NCT00801684|O5|Outcome|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
1006189|NCT00801138|P2|Participant Flow|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
1006190|NCT00801138|P1|Participant Flow|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
1006191|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
1006141|NCT00801684|O4|Outcome|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
1006142|NCT00801684|O3|Outcome|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
1006143|NCT00801684|O2|Outcome|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006144|NCT00801684|O1|Outcome|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006145|NCT00801684|E6|Reported Event|Placebo|Subjects were administered placebo over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Placebo was supplied as empty Size-2 capsules and administered via a dry powder inhaler.
1006146|NCT00801684|E5|Reported Event|TrIP-2SS (100mcg) + Foradil (12mcg)|Subjects were administered TrIP (100mcg)plus Foradil (12mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Foradil (12mcg)and Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006147|NCT00801684|E4|Reported Event|TrIP-2D (400mcg)|Subjects were administered TrIP-2D (400mcg)over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 μg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 μg TrCl) or 4 capsules (400 μg TrCl) were used. A separate inhaler was provided for each capsule.
1006148|NCT00801684|E3|Reported Event|TrIP-2SS (100mcg)|Subjects were administered TrIP (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and sodium saccharin, supplied as dry powder in size-2 capsules, was administered via a dry powder inhaler.
1006149|NCT00801684|E2|Reported Event|TrIP-2D (100mcg)|Subjects were administered TrIP-2D (100mcg) over 5 dosing periods, each separated by a 3- to 14 day washout period. Subjects reported to the clinic the evening prior to each dose, and assessments were carried out through 24 hours postdose. A 3- to 14-day washout period was maintained between doses. Trospium inhalation powder containing 2% TrCl (100 mcg) formulated in leucine and DPPC; supplied as dry powder in size-2 capsules and administered via dry powder inhaler. One capsule (100 mcg TrCl) or 4 capsules (400 mcg TrCl) were used. A separate inhaler was provided for each capsule.
1006150|NCT00801684|E1|Reported Event|Overall Study|
1006151|NCT00801632|B1|Baseline|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006152|NCT00801632|P1|Participant Flow|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006192|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
1006193|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
1006153|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006154|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006155|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006156|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006157|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006158|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006159|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006194|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
1006195|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
1006196|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
1006197|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
1006160|NCT00801632|O1|Outcome|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006161|NCT00801632|E1|Reported Event|MEDI-507|Recipients received a conditioning treatment that started with rituximab (375 mg/m^2 infusion) on days -7, -2, 5 and 12. Cyclophosphamide (60 mg/kg) on days -5 and -4, followed by hemodialysis. MEDI-507, a T-cell-depleting agent, was given at 0.1 mg/kg on day -2 and 0.6 mg/kg on days -1, 0 and 1. Thymic irradiation (700 cGy) was given on day -1. Recipients underwent surgical transplantation of a donor kidney on day 0. During kidney transplant, bone marrow cells donated by the same donor as the kidney were given through a plastic tube placed in a vein in the chest, underneath the collarbone. Prednisone was started at 2 mg/kg/day on day 4 and tapered off by day 20. A steroid pulse (methylprednisolone 500 mg) was given on days 10, 11, and 12. Tacrolimus (0.05 mg/kg twice a day, adjusted to trough level of 10-15 ng/mL) was given starting on day -1. When the subject met weaning criteria, tacrolimus was tapered over a period of no less than 8 weeks beginning 60 days post-transplant.
1006162|NCT00801242|B1|Baseline|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006163|NCT00801242|P1|Participant Flow|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006164|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006165|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006166|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006167|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006168|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006169|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006170|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006171|NCT00801242|O1|Outcome|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix were administered 28 days apart via single s.c. injections.
1006172|NCT00801242|E1|Reported Event|Degarelix 240 mg / 80 mg|Degarelix 240 mg / 80 mg: For each treatment cycle, a starting dose of 240 mg of degarelix at a concentration of 40 mg/mL was administered on Day 0 as two 120 mg subcutaneous (s.c.) injections in the abdominal region. Thereafter, 6 doses of 80 mg degarelix at a concentration of 20 mg/mL were administered 28 days apart via single s.c. injections.
1006173|NCT00801229|B3|Baseline|Total|Total of all reporting groups
1006174|NCT00801229|B2|Baseline|Placebo|
1006175|NCT00801229|B1|Baseline|Vyvanse|
1006176|NCT00801229|P2|Participant Flow|Placebo|
1006177|NCT00801229|P1|Participant Flow|Vyvanse|
1006178|NCT00801229|O2|Outcome|Placebo|
1006179|NCT00801229|O1|Outcome|Vyvanse|
1006180|NCT00801229|E2|Reported Event|Placebo|
1006181|NCT00801229|E1|Reported Event|Vyvanse|
1006182|NCT00801138|B5|Baseline|Total|Total of all reporting groups
1006183|NCT00801138|B4|Baseline|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
1006184|NCT00801138|B3|Baseline|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
1006185|NCT00801138|B2|Baseline|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
1006186|NCT00801138|B1|Baseline|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
1006187|NCT00801138|P4|Participant Flow|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
1006188|NCT00801138|P3|Participant Flow|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
1006200|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
1006201|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
1006202|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
1006203|NCT00801138|O4|Outcome|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
1006204|NCT00801138|O3|Outcome|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
1006205|NCT00801138|O2|Outcome|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
1006206|NCT00801138|O1|Outcome|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
1006207|NCT00801138|E4|Reported Event|Group 4|"Group 4 Bupivacaine and steroid:~Bupivacaine plus dexamethasone~Bupivacaine~Dexamethasone: steroid"
1006208|NCT00801138|E3|Reported Event|Group 3|"Group 3 Ropivacaine and dexamethasone:~Ropivacaine plus dexamethasone~Ropivacaine~Dexamethasone: steroid"
1006209|NCT00801138|E2|Reported Event|Group 2|"Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline~Bupivacaine~Placebo: saline"
1006210|NCT00801138|E1|Reported Event|Group 1|"Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block~Ropivacaine~Placebo: saline"
1006211|NCT00801099|B1|Baseline|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
1006212|NCT00801099|P1|Participant Flow|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
1006213|NCT00801099|O1|Outcome|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
1006214|NCT00801099|E1|Reported Event|Amoxicillin/Clavulanic Acid|Single shot dose of Amoxicillin/Clavulanic Acid approximately 30 minutes preoperatively.
1006215|NCT00800982|B3|Baseline|Total|Total of all reporting groups
1006216|NCT00800982|B2|Baseline|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
1006217|NCT00800982|B1|Baseline|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
1006218|NCT00800982|P2|Participant Flow|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive Narrow Band Ultraviolet B phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. Narrow Band Ultraviolet B therapy will be adjusted according to the clinical judgment of the University of California San Francisco Psoriasis Treatment Center phototherapy staff."
1006219|NCT00800982|P1|Participant Flow|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No Ultraviolet B will be given. Sham Ultraviolet B will not be used because the subjects are not blinded because they often know they are receiving sham Ultraviolet B due to differences in light intensity and heat.
1006220|NCT00800982|O2|Outcome|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
1006221|NCT00800982|O1|Outcome|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
1006222|NCT00800982|E2|Reported Event|2 (Etanercept + Nb-UVB)|"Subjects will receive etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months.~In addition, for months 3-6, subjects will receive NB-UVB phototherapy three times a week for 12 weeks in addition to the etanercept maintenance dose. The safety and efficacy of the combination therapy will be evaluated by the registered phototherapy nurses at each phototherapy visit and by the study investigator at monthly visits. NB-UVB therapy will be adjusted according to the clinical judgment of the UCSF Psoriasis Treatment Center phototherapy staff."
1006223|NCT00800982|E1|Reported Event|1 (Etanercept Only)|Subjects will only be treated with etanercept. This is given at the standard FDA approved dosage of 50 mg twice weekly x 3 months then 50 mg once weekly x 3 months. No UVB will be given. Sham UVB will not be used because the subjects are not blinded because they often know they are receiving sham UVB due to differences in light intensity and heat.
1006224|NCT00800865|B3|Baseline|Total|Total of all reporting groups
1006225|NCT00800865|B2|Baseline|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
1006245|NCT00800735|P1|Participant Flow|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
1006226|NCT00800865|B1|Baseline|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
1006227|NCT00800865|P2|Participant Flow|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
1006228|NCT00800865|P1|Participant Flow|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
1006229|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
1006230|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
1006231|NCT00800865|O2|Outcome|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
1006232|NCT00800865|O1|Outcome|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
1006233|NCT00800865|E2|Reported Event|Biomarker Evaluation Group II|A second group of participants who had blood and urine samples collected at Visit 1 (there was no baseline). After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at at 24, 32 and 48 hours post dosing with cytotoxic agent(s).
1006234|NCT00800865|E1|Reported Event|Biomarker Evaluation Group I|Participants who had blood and urine samples collected at Visit 1. After allocation, punch skin biopsies, plucked hair samples, blood, and urine were collected at baseline, and at 24 and 48 hours post dosing with cytotoxic agent(s). An additional sample collection at 32 hours may have been performed if deemed necessary after review of the data.
1006235|NCT00800839|B1|Baseline|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006236|NCT00800839|P1|Participant Flow|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006237|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006238|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006239|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006240|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006241|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006242|NCT00800839|O1|Outcome|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006243|NCT00800839|E1|Reported Event|Busulfan + Fludarabine + Cyclophosphamide|Busulfan starting dose of 32 mg/m^2 by vein over 3 hours each day. Test dose day -8 (inpatient) or test dose day -30 to day -8 (outpatient) and then, days -6,-5,-4, and -3. Fludarabine dose of 40 mg/m^2 by vein over 1 hour each day on Day -6 through Day -3 before receiving Busulfan. Cyclophosphamide dose of 50 mg/kg by vein over 3 hours on Days 3 and 4.
1006244|NCT00800735|B1|Baseline|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
1006246|NCT00800735|O1|Outcome|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
1006247|NCT00800735|E1|Reported Event|Pegylated-interferon Alfa-2a Plus Ribavirin|Participants received pegylated-interferon alfa-2a 180 µg/week subcutaneously plus ribavirin 1000 mg/day orally for patients weighing < 75 kg or 1200 mg/day for patients weighing ≥ 75 kg for 48 weeks.
1006248|NCT00800683|B3|Baseline|Total|Total of all reporting groups
1006249|NCT00800683|B2|Baseline|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006250|NCT00800683|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
1006251|NCT00800683|P2|Participant Flow|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006252|NCT00800683|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
1006253|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006254|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006255|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006256|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006257|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006258|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006259|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006260|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006261|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006262|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006263|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006264|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006265|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006266|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006267|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006268|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006269|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006270|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006271|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006272|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006273|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006274|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006275|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006276|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006277|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006278|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006279|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006280|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006281|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006282|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006283|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006284|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006285|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006286|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006287|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006288|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006289|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006290|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006291|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006292|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006293|NCT00800683|O2|Outcome|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006294|NCT00800683|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
1006295|NCT00800683|E2|Reported Event|Linagliptin (BI 1356)|Patients randomized to receive treatment with Linagliptin 5mg
1006296|NCT00800683|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
1006297|NCT00800540|B1|Baseline|Overall|All enrolled
1006298|NCT00800540|P2|Participant Flow|COMBIGAN/AZARGA|COMBIGAN, followed by AZARGA, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
1006299|NCT00800540|P1|Participant Flow|AZARGA/COMBIGAN|AZARGA, followed by COMBIGAN, as randomized. Each fixed combination was used for 6 weeks, with a 4-week washout period separating the two treatment periods.
1006300|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006301|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006304|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006305|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006306|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006307|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006308|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006309|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006310|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006311|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006312|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006313|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006314|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006315|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006316|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006317|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006318|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006319|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006320|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006321|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006322|NCT00800540|O2|Outcome|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006323|NCT00800540|O1|Outcome|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006324|NCT00800540|E2|Reported Event|COMBIGAN|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006325|NCT00800540|E1|Reported Event|AZARGA|One drop in the study eye, twice daily (9:00 and 21:00), for six weeks
1006326|NCT00800436|B8|Baseline|Total|Total of all reporting groups
1006327|NCT00800436|B7|Baseline|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006328|NCT00800436|B6|Baseline|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006329|NCT00800436|B5|Baseline|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006330|NCT00800436|B4|Baseline|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006331|NCT00800436|B3|Baseline|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
1006332|NCT00800436|B2|Baseline|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006333|NCT00800436|B1|Baseline|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
1006334|NCT00800436|P7|Participant Flow|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006335|NCT00800436|P6|Participant Flow|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006336|NCT00800436|P5|Participant Flow|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006337|NCT00800436|P4|Participant Flow|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006338|NCT00800436|P3|Participant Flow|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg subcutaneously (SC) on Day 1.
1006339|NCT00800436|P2|Participant Flow|Part 1: Cohort 2|Female participants with human epidermal growth factor receptor 2 (HER2)-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006340|NCT00800436|P1|Participant Flow|Part 1: Cohort 1|Healthy male participants received Herceptin 6 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1.
1006341|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006342|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006343|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006344|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006345|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
1006346|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006347|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
1006348|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006349|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006350|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006351|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006352|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
1006353|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006354|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
1006355|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006356|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006357|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006358|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006359|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
1006360|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006361|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
1006362|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006363|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006364|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006365|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006366|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
1006367|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006368|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
1006369|NCT00800436|O7|Outcome|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006370|NCT00800436|O6|Outcome|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006371|NCT00800436|O5|Outcome|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006372|NCT00800436|O4|Outcome|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006373|NCT00800436|O3|Outcome|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
1006374|NCT00800436|O2|Outcome|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006375|NCT00800436|O1|Outcome|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
1006376|NCT00800436|E7|Reported Event|Part 2: Cohort B|Female participants with HER2-positive breast cancer received Herceptin 12 mg/kg SC on Day 1.
1006377|NCT00800436|E6|Reported Event|Part 2: Cohort A|Female participants with HER2-positive breast cancer received Herceptin 8 mg/kg SC on Day 1.
1006378|NCT00800436|E5|Reported Event|Part 1: Cohort 5|Healthy male participants received Herceptin 8 mg/kg SC on Day 1.
1006379|NCT00800436|E4|Reported Event|Part 1: Cohort 4|Healthy male participants received Herceptin 10 mg/kg SC on Day 1.
1006380|NCT00800436|E3|Reported Event|Part 1: Cohort 3|Healthy male participants received Herceptin 6 mg/kg SC on Day 1.
1006381|NCT00800436|E2|Reported Event|Part 1: Cohort 2|Female participants with HER2-positive breast cancer received Herceptin 6 mg/kg IV on Day 1.
1006382|NCT00800436|E1|Reported Event|Part 1: Cohort 1|Healthy male participants received Herceptin 6 mg/kg IV on Day 1.
1006383|NCT00800384|B3|Baseline|Total|Total of all reporting groups
1006384|NCT00800384|B2|Baseline|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
1006385|NCT00800384|B1|Baseline|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
1006386|NCT00800384|P2|Participant Flow|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
1006387|NCT00800384|P1|Participant Flow|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
1006388|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and ventricular fibrillation (VF) induction was performed followed by shock delivery to test shock efficacy at implant.
1006389|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
1006390|NCT00800384|O2|Outcome|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
1006391|NCT00800384|O1|Outcome|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
1006392|NCT00800384|E2|Reported Event|ICD Implant With Defibrillation Testing|Patients in this arm were implanted with their ICD and VF induction was performed followed by shock delivery to test shock efficacy at implant.
1006393|NCT00800384|E1|Reported Event|ICD Implant Without Defibrillation Testing|Patients in this arm were implanted with their ICD without having the defibrillation test performed at implant. No VF induction was performed.
1006394|NCT00800345|B1|Baseline|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
1006395|NCT00800345|P1|Participant Flow|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
1006501|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
1006502|NCT00799643|O2|Outcome|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
1006503|NCT00799643|O1|Outcome|Placebo|Placebo for salsalate, orally, divided dosing
1006396|NCT00800345|O1|Outcome|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
1006397|NCT00800345|O1|Outcome|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
1006398|NCT00800345|E1|Reported Event|Experimental|"Metronomic oral topotecan and oral pazopanib will be administered by mouth beginning on Cycle 1 Day 1. Patients will be enrolled and observed for dose limiting toxicity (DLT) for 1 cycle of treatment. Dose modification of the combination will depend on the number of patients experiencing DLT(s) at each dose level.~Oral Topotecan: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of topotecan administered by mouth.~Pazopanib: Starting on Cycle 1 Day 1, each subject will receive the assigned dose of pazopanib administered by mouth."
1006399|NCT00800254|B3|Baseline|Total|Total of all reporting groups
1006400|NCT00800254|B2|Baseline|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006401|NCT00800254|B1|Baseline|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006402|NCT00800254|P2|Participant Flow|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006403|NCT00800254|P1|Participant Flow|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006404|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006405|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006406|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006407|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006408|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006409|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006410|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006411|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006412|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006413|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006414|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006415|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006416|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006417|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006418|NCT00800254|O2|Outcome|Standard Rehabilitation Protocol (Control)|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006419|NCT00800254|O1|Outcome|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006420|NCT00800254|E2|Reported Event|Standard Rehabilitation Protocol|Standard Rehabilitation Protocol: Standard physical therapy for 8 weeks after surgery
1006421|NCT00800254|E1|Reported Event|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular Electrical Stimulation (NMES): NMES 20 minutes twice a day for 6 weeks plus standard physical therapy
1006422|NCT00800202|B3|Baseline|Total|Total of all reporting groups
1006423|NCT00800202|B2|Baseline|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006424|NCT00800202|B1|Baseline|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006425|NCT00800202|P2|Participant Flow|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib150 milligrams per day (mg/day) administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006504|NCT00799643|E2|Reported Event|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
1006505|NCT00799643|E1|Reported Event|Placebo|Placebo for salsalate, orally, divided dosing
1006506|NCT00799604|B4|Baseline|Total|Total of all reporting groups
1006426|NCT00800202|P1|Participant Flow|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 milligrams per square meter (mg/m^2) iv every 3 weeks for 6 cycles and carboplatin Area Under Curve (AUC) 6.0 milligrams per milliliter per minute (mg/mL/min) iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006427|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006428|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006429|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006430|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006431|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006432|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006433|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006434|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006435|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006436|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006437|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006438|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006439|NCT00800202|O2|Outcome|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006440|NCT00800202|O1|Outcome|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006441|NCT00800202|E2|Reported Event|Bevacizumab+Erlotinib|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with erlotinib 150 mg/day administered as tablets orally until progression or unacceptable toxicity. Bevacizumab was used as second-line treatment in addition to erlotinib.
1006442|NCT00800202|E1|Reported Event|Bevacizumab+Paclitaxel+Carboplatin|Participants received bevacizumab 15 mg/kg iv every 3 weeks until progression or unacceptable toxicity along with paclitaxel 200 mg/m^2 iv every 3 weeks for 6 cycles and carboplatin: AUC 6.0 mg/mL/min iv every 3 weeks for 6 cycles. Bevacizumab was used in addition to standard first line chemotherapy.
1006443|NCT00799825|B1|Baseline|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
1006444|NCT00799825|P1|Participant Flow|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
1006445|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
1006605|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006446|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
1006447|NCT00799825|O1|Outcome|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
1006448|NCT00799825|E1|Reported Event|Cervarix Group|Female subjects who previously received the active control i.e. Hepatitis A vaccine in the primary study (NCT00122681) and who received the Cervarix vaccine in the current study. The Cervarix vaccine was administered intramuscularly into the deltoid muscle of the non-dominant arm according to a 0, 1 and 6 months schedule.
1006449|NCT00799773|B3|Baseline|Total|Total of all reporting groups
1006450|NCT00799773|B2|Baseline|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006451|NCT00799773|B1|Baseline|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006452|NCT00799773|P2|Participant Flow|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006453|NCT00799773|P1|Participant Flow|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006454|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006455|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006456|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006457|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006458|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006459|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006460|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006461|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006462|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006463|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006464|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006465|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006466|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006467|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006468|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006469|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006470|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006471|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006472|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006473|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006474|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006475|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006476|NCT00799773|O2|Outcome|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006477|NCT00799773|O1|Outcome|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006478|NCT00799773|E2|Reported Event|Standard of Care|Participants will receive plasma exchange and corticosteroids.
1006479|NCT00799773|E1|Reported Event|Rituximab|Participants will receive rituximab in addition to plasma exchange and corticosteroids.
1006480|NCT00799708|B4|Baseline|Total|Total of all reporting groups
1006481|NCT00799708|B3|Baseline|Placebo|Placebo capsule once daily for 7 days.
1006482|NCT00799708|B2|Baseline|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
1006483|NCT00799708|B1|Baseline|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
1006484|NCT00799708|P3|Participant Flow|Placebo|Placebo capsule once daily for 7 days.
1006485|NCT00799708|P2|Participant Flow|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
1006486|NCT00799708|P1|Participant Flow|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
1006487|NCT00799708|O2|Outcome|Placebo|
1006488|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|
1006489|NCT00799708|O3|Outcome|Placebo|Placebo capsule once daily for 7 days.
1006490|NCT00799708|O2|Outcome|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
1006491|NCT00799708|O1|Outcome|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
1006492|NCT00799708|E3|Reported Event|Placebo|Placebo capsule once daily for 7 days.
1006493|NCT00799708|E2|Reported Event|17β-estradiol 0.5 Milligrams|Estrace 0.5 mg tablets once daily for 7 days.
1006494|NCT00799708|E1|Reported Event|17β-estradiol 2.0 Milligrams|Estrace 2 mg tablets once daily for 7 days.
1006495|NCT00799643|B3|Baseline|Total|Total of all reporting groups
1006496|NCT00799643|B2|Baseline|Salsalate|Salsalate, 3.5 g/d orally, divided dosing
1006497|NCT00799643|B1|Baseline|Placebo|Placebo for salsalate, orally, divided dosing
1006498|NCT00799643|P2|Participant Flow|Salsalate|Salsalate, 3.5 g/d orally,divided dosing
1006499|NCT00799643|P1|Participant Flow|Placebo|Placebo for salsalate, orally, divided dosing
1006507|NCT00799604|B3|Baseline|Cohort 3: Clevidipine 125 μg ( mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006508|NCT00799604|B2|Baseline|Cohort 2: Clevidipine 500 μg (1.0 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which Clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006509|NCT00799604|B1|Baseline|Cohort 1: Clevidipine 250 μg (0.5 mL)|Baseline characteristics are reflective of the participant groupings during Treatment Period 1 (10 participants per cohort) during which clevidipine was administered at 250 μg prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006510|NCT00799604|P3|Participant Flow|Planned Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Three participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 received a Bolus 2 dose of 125 μg during Treatment Period 2 in this cohort.
1006511|NCT00799604|P2|Participant Flow|Planned Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Six participants who received a Bolus 1 dose of 500 μg and six participants who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 500 μg during Treatment Period 2 in this cohort.
1006512|NCT00799604|P1|Participant Flow|Planned Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (<5 seconds) (Bolus 1 - pre-anesthesia) by rapid injection. At the discretion of the investigator, a second bolus (Bolus 2 - with anesthesia) could be administered during Treatment Period 2 after induction of general anesthesia at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1. Five participants who received a Bolus 1 dose of 250 μg during Treatment Period 1 and one participant who received a Bolus 1 dose of 125 μg during Treatment Period 1 received a Bolus 2 dose of 250 μg during Treatment Period 2 in this cohort.
1006513|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006514|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006515|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006516|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006517|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006518|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006519|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006520|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006521|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006522|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006523|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006524|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006525|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006526|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006527|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006528|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006529|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006530|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006531|NCT00799604|O3|Outcome|Cohort 3: Clevidipine 125 μg (0.25 mL or 0.5 mL of a 1:1 Sol)|Clevidipine was administered at 125 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006532|NCT00799604|O2|Outcome|Cohort 2: Clevidipine 500 μg (1.0 mL)|Clevidipine was administered at 500 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006533|NCT00799604|O1|Outcome|Cohort 1: Clevidipine 250 μg (0.5 mL)|Clevidipine was administered at 250 μg during Treatment Period 1 prior to induction of general anesthesia as an IV bolus (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds).
1006534|NCT00799604|E1|Reported Event|All Participants Across All Cohorts and Treatment Periods|Study participants were sequentially assigned one of three cohorts to receive either a 250 μg, 500 μg or 125 μg bolus dose of clevidipine during Treatment Period 1 prior to induction of general anesthesia (Bolus 1 - pre-anesthesia) by rapid injection (<5 seconds). At the discretion of the investigator, a second bolus could be administered during Treatment Period 2 after induction of general anesthesia (Bolus 2 - with anesthesia) at 125 μg, 250 μg or 500 μg based upon the earlier observed response to Bolus 1.
1006535|NCT00799591|B1|Baseline|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006536|NCT00799591|P1|Participant Flow|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006537|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006538|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006539|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006540|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006541|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006542|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006543|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006544|NCT00799591|O1|Outcome|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006545|NCT00799591|E1|Reported Event|Tigecycline|Use and dosage recommendations for tigecycline (Tygacil®) were on the basis of the approved Summary of Product Characteristics (SmPC) and adjusted solely according to medical and therapeutic necessity. Tigecycline powder for solution for intravenous (IV) infusion could be administered with an initial loading dose of 100 milligrams (mg) followed by 50 mg administered IV (over 30 to 60 minutes) every 12 hours for 5 to 14 days.
1006546|NCT00799578|B1|Baseline|Cystagon-EC|
1006547|NCT00799578|P1|Participant Flow|Cystagon-EC|
1006548|NCT00799578|O1|Outcome|Number of Improved Subjects|
1006549|NCT00799578|E1|Reported Event|Number of Improved Subjects|
1006550|NCT00799487|B4|Baseline|Total|Total of all reporting groups
1006551|NCT00799487|B3|Baseline|Concerta/Placebo|Children randomized to receive Concerta at lab school day 1 and Placebo at lab school day 2
1006552|NCT00799487|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and Concerta lab school day 2
1006553|NCT00799487|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
1006554|NCT00799487|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
1006555|NCT00799487|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
1006556|NCT00799487|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
1006557|NCT00799487|O3|Outcome|Concerta|Chilfdren randomized to receive Concerta at lab school day 1 or lab school day 2
1006558|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006559|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006560|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006561|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006562|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006563|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006564|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006565|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006566|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006567|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006568|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006569|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006570|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006571|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006572|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006573|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006574|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006575|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006576|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006577|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006578|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006579|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006580|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006581|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006582|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006583|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006584|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006585|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006586|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006587|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006588|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006589|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006590|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006591|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006592|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006593|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006594|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006595|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006596|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006597|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006598|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006599|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006600|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006601|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006602|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006603|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006604|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006606|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006607|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006608|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006609|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or at lab school day 2
1006610|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006611|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006612|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006613|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006614|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006615|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006616|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006617|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006618|NCT00799487|O2|Outcome|Placebo|Chidren randomized to receive Placebo at lab school day 1 or lab school day 2
1006619|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006620|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006621|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006622|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006623|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006624|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006625|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006626|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006627|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006628|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006629|NCT00799487|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006630|NCT00799487|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006631|NCT00799487|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006632|NCT00799487|E3|Reported Event|Open Label|dose adjustment period and double blind period other than lab school day
1006633|NCT00799487|E2|Reported Event|Concerta|Concerta was received during the lab school day
1006634|NCT00799487|E1|Reported Event|Placebo|Placebo was received during the lab school day
1006635|NCT00799474|B1|Baseline|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
1006636|NCT00799474|P1|Participant Flow|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
1006637|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
1006638|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
1006639|NCT00799474|O1|Outcome|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
1006640|NCT00799474|E1|Reported Event|Study Participants|All study participants, this observational study was not a trial that involved multiple arms
1006641|NCT00799422|B1|Baseline|Overall|Baseline characteristics are presented for all participants completing all three treatment sequences.
1006642|NCT00799422|P6|Participant Flow|Clear Care / Complete / ReNu|Clear Care, then Complete Easy Rub, then ReNu MultiPlus, 1 week each
1006643|NCT00799422|P5|Participant Flow|Complete / ReNu / Clear Care|Complete Easy Rub, then ReNu MultiPlus), then Clear Care, 1 week each
1006644|NCT00799422|P4|Participant Flow|ReNu / Clear Care / Complete|ReNu MultiPlus, then Clear Care, then Complete Easy Rub, 1 week each
1006645|NCT00799422|P3|Participant Flow|Clear Care / ReNu / Complete|Clear Care, then ReNu MultiPlus, then Complete Easy Rub, 1 week each
1006646|NCT00799422|P2|Participant Flow|Complete / Clear Care / ReNu|Complete Easy Rub, then Clear Care, then ReNu MultiPlus, 1 week each
1006647|NCT00799422|P1|Participant Flow|ReNu / Complete / Clear Care|ReNu Multiplus, then Complete Easy Rub, then Clear Care, 1 week each
1006648|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
1006649|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
1006650|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
1006651|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
1006652|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
1006653|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
1006654|NCT00799422|O3|Outcome|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
1006655|NCT00799422|O2|Outcome|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
1006656|NCT00799422|O1|Outcome|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
1006657|NCT00799422|E3|Reported Event|Clear Care|Clear Care used for one week as specified in the protocol with study contact lenses.
1007088|NCT00798161|B2|Baseline|M500BID|Patients treated with Metformin 500mg BID
1006658|NCT00799422|E2|Reported Event|Complete Easy Rub|Complete Easy Rub used for one week as specified in the protocol with study contact lenses.
1006659|NCT00799422|E1|Reported Event|ReNu MultiPlus|ReNu MultiPlus used for one week as specified in the protocol with study contact lenses.
1006660|NCT00799409|B4|Baseline|Total|Total of all reporting groups
1006661|NCT00799409|B3|Baseline|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
1006662|NCT00799409|B2|Baseline|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
1006663|NCT00799409|B1|Baseline|Not Randomized|Children who started dose adjustment period, but were not randomized
1006664|NCT00799409|P3|Participant Flow|Concerta/Placebo|Children randomized to receive an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 1 and Placebo at lab school day 2
1006665|NCT00799409|P2|Participant Flow|Placebo/Concerta|Children randomized to receive Placebo at lab school day 1 and an individualized, optimal dose of Concerta (18mg, 36mg, or 54mg tablet) once daily at lab school day 2
1006666|NCT00799409|P1|Participant Flow|Not Randomized|Children who started dose adjustment period, but were not randomized
1006667|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006668|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006669|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006670|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006671|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006672|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006673|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006674|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006675|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006676|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006677|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006678|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006679|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006680|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006681|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006682|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006683|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006684|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006685|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006686|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006687|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006688|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006689|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006690|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006691|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006692|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006693|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006694|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006695|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006696|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006697|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006698|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006699|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006700|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006701|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006702|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006703|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006704|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006705|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006706|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006707|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006708|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006709|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006710|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006711|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006712|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006713|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006714|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006715|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006716|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006717|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006718|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006719|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006720|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006721|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006722|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006723|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006724|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006725|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006726|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006727|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006728|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006729|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006730|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006731|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006732|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006733|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006734|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006735|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006736|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006737|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006738|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006739|NCT00799409|O3|Outcome|Concerta|Children randomized to receive Concerta at lab school day 1 or lab school day 2
1006740|NCT00799409|O2|Outcome|Placebo|Children randomized to receive Placebo at lab school day 1 or lab school day 2
1006741|NCT00799409|O1|Outcome|Not Randomized|Children who started dose adjustment period, but were not randomized
1006742|NCT00799409|E3|Reported Event|Open Label/Non-Lab Day CONCERTA|Dose adjustment period and double blind period other than lab school day
1006743|NCT00799409|E2|Reported Event|Concerta|Concerta was received during the lab school day
1006744|NCT00799409|E1|Reported Event|Placebo|Placebo was received during the lab school day
1006745|NCT00799396|B1|Baseline|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
1006746|NCT00799396|P1|Participant Flow|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
1006747|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment~PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation~PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
1006748|NCT00799396|O1|Outcome|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment~PRP ADP 20 = Platelet Rich Plasma ADP-induced (20 microM) aggregation~PRP Collagen 5 = Platelet Rich Plasma Collegan-induced (5 microM) aggregation"
1006749|NCT00799396|E1|Reported Event|Overall Study|"Participants will receive clopidogrel treatment alone, followed by clopidogrel plus aspirin treatment on the last day of treatment.~Clopidogrel: 300 mg on first day, then 75 mg per day for the next 6 days~Aspirin: Single dose of 324 mg on the last day of clopidogrel treatment"
1006750|NCT00799292|B3|Baseline|Total|Total of all reporting groups
1006751|NCT00799292|B2|Baseline|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
1006752|NCT00799292|B1|Baseline|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
1006753|NCT00799292|P2|Participant Flow|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
1006754|NCT00799292|P1|Participant Flow|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
1006755|NCT00799292|O2|Outcome|Injection of Vasopressin|Patients will be randomized to receive 20cc of dilute vasopressin (20 units in 50cc normal saline) injected at cervix at beginning of the hysterectomy.
1006756|NCT00799292|O1|Outcome|No Injection|Patients did not receive an injection at cervix prior to beginning the procedure.
1006757|NCT00799227|B1|Baseline|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
1006758|NCT00799227|P1|Participant Flow|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
1006759|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
1006760|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
1006761|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
1006762|NCT00799227|O1|Outcome|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
1006763|NCT00799227|E1|Reported Event|700 µg Dexamethasone Implant|700 µg dexamethasone implant in the study eye at Day 1
1006764|NCT00798967|B3|Baseline|Total|Total of all reporting groups
1006765|NCT00798967|B2|Baseline|Placebo|Matching sc dose of placebo to teduglutide
1006766|NCT00798967|B1|Baseline|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
1006767|NCT00798967|P2|Participant Flow|Placebo|Matching sc dose of placebo to teduglutide
1006768|NCT00798967|P1|Participant Flow|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
1006769|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
1006770|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day sc dose of teduglutide
1006771|NCT00798967|O2|Outcome|Placebo|Matching sc dose of placebo to teduglutide
1006772|NCT00798967|O1|Outcome|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
1006773|NCT00798967|E2|Reported Event|Placebo|Matching sc dose of placebo to teduglutide
1006774|NCT00798967|E1|Reported Event|Teduglutide|0.05 mg/kg/day subcutaneous (sc) dose of teduglutide
1006775|NCT00798889|B1|Baseline|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
1006776|NCT00798889|P1|Participant Flow|Sunitinib|Sunitinib 50 milligram (mg) capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
1006777|NCT00798889|O1|Outcome|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
1006778|NCT00798889|E1|Reported Event|Sunitinib|Sunitinib 50 mg capsule orally once daily in schedule 4/2 (4 weeks on treatment, 2 weeks off treatment) or schedule 2/1 (2 weeks on treatment, 1 week off treatment) or Schedule 2/2 (2 weeks on treatment, 2 weeks off treatment) or continuous dosing, based on investigator’s discretion.
1006779|NCT00798759|B3|Baseline|Total|Total of all reporting groups
1006780|NCT00798759|B2|Baseline|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1006781|NCT00798759|B1|Baseline|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1006782|NCT00798759|P2|Participant Flow|Latanoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1006783|NCT00798759|P1|Participant Flow|Travoprost|One drop self-administered in the study eye(s) once daily at night for 12 weeks
1006784|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1006785|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1006786|NCT00798759|O2|Outcome|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1006787|NCT00798759|O1|Outcome|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1006788|NCT00798759|E2|Reported Event|Latanoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1006789|NCT00798759|E1|Reported Event|Travoprost|One drop self administered in the study eye(s) once daily at night for 12 weeks
1006790|NCT00798720|B1|Baseline|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
1006791|NCT00798720|P1|Participant Flow|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
1006792|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
1006793|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
1006794|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
1006795|NCT00798720|O1|Outcome|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
1006796|NCT00798720|E1|Reported Event|Vorinostat + Bortezomib|"Vorinostat 400 mg + Bortezomib 1.3 mg/m2~vorinostat: 400 mg by mouth once daily for days 1-14 of each 21 day cycle~bortezomib: 1.3 mg/m2 IV on days 1, 4, 8, 11 of each 21 day cycle"
1006797|NCT00798707|B4|Baseline|Total|Total of all reporting groups
1006798|NCT00798707|B3|Baseline|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006799|NCT00798707|B2|Baseline|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006800|NCT00798707|B1|Baseline|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006801|NCT00798707|P3|Participant Flow|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006802|NCT00798707|P2|Participant Flow|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006803|NCT00798707|P1|Participant Flow|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006804|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006805|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006806|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006807|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006808|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006809|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006810|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006811|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006812|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006813|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006814|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006815|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006816|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006817|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006818|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006819|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006820|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006821|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006822|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006823|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006824|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006825|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006826|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006827|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006828|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006829|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006830|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006831|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006832|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006833|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006834|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006835|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006836|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006837|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006838|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006839|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006840|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006841|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006842|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006843|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006844|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006845|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006846|NCT00798707|O3|Outcome|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006847|NCT00798707|O2|Outcome|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006848|NCT00798707|O1|Outcome|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006849|NCT00798707|E3|Reported Event|DVS SR 50 mg|DVS SR 50 mg daily until Day 56 (Week 8) or ET.
1006850|NCT00798707|E2|Reported Event|DVS SR 25 mg|Desvenlafaxine Succinate Sustained Release (DVS SR) 25 mg daily until Day 56 (Week 8) or ET.
1006851|NCT00798707|E1|Reported Event|Placebo|Matching placebo tablets daily until Day 56 (Week 8) or early termination (ET) .
1006852|NCT00798655|B1|Baseline|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
1006853|NCT00798655|P1|Participant Flow|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
1006892|NCT00798577|E2|Reported Event|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1020857|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1006854|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
1006855|NCT00798655|O1|Outcome|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
1006856|NCT00798655|E1|Reported Event|Radiation Therapy+Cisplatin+Panitumumab|Postoperative treatment consisted of standard radiation therapy (60-66 Gy over 6-7 weeks) concurrent with weekly cisplatin 30 mg/m^2 and weekly panitumumab 2.5 mg/kg. (no prior chemotherapy, biologic/targeted therapy, or radiation therapy).
1006857|NCT00798603|B1|Baseline|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006858|NCT00798603|P1|Participant Flow|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006859|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006860|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006861|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006862|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006863|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006864|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006865|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006866|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006867|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006868|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006869|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006870|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006871|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006872|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006873|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006874|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006875|NCT00798603|O1|Outcome|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006876|NCT00798603|E1|Reported Event|Pemetrexed + Carboplatin + Bevacizumab|Patients receive pemetrexed disodium IV over 10 minutes, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1.
1006877|NCT00798577|B3|Baseline|Total|Total of all reporting groups
1006878|NCT00798577|B2|Baseline|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1006879|NCT00798577|B1|Baseline|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1006880|NCT00798577|P2|Participant Flow|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1006881|NCT00798577|P1|Participant Flow|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1006882|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1006883|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1006884|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1006885|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1006886|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1006887|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1006888|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1006889|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1006890|NCT00798577|O2|Outcome|Placebo|Balanced Salt Solution (BSS) placebo for 3 doses, then Moxifloxacin 5mg/mL 3 times daily for 7 days
1006891|NCT00798577|O1|Outcome|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1020858|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1006893|NCT00798577|E1|Reported Event|Vigamox|Vigamox Ophthalmic Solution (Moxifloxacin 5 mg/mL) three times daily for 7 days
1006894|NCT00798486|B1|Baseline|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
1006895|NCT00798486|P1|Participant Flow|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
1006896|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
1006897|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
1006898|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
1006899|NCT00798486|O1|Outcome|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
1006900|NCT00798486|E1|Reported Event|Subjects With and Without Diabetes|Subjects participating in this study included 93 who had diabetes and 17 who did not have diabetes.
1006901|NCT00798434|B3|Baseline|Total|Total of all reporting groups
1006902|NCT00798434|B2|Baseline|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006903|NCT00798434|B1|Baseline|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006904|NCT00798434|P2|Participant Flow|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006905|NCT00798434|P1|Participant Flow|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 milligrams (mg) once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006906|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006907|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006908|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006909|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006910|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006911|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006912|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006913|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006914|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006915|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006916|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006917|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006918|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006919|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1007089|NCT00798161|B1|Baseline|Placebo|Patients treated with matching placebo
1006920|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006921|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006922|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006923|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006924|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006925|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006926|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006927|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006928|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to 8 mg once daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006929|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006930|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006931|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006932|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006933|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006934|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006935|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006936|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006937|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006938|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006939|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006940|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006941|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006942|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006943|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006944|NCT00798434|O2|Outcome|Fesoterodine/Fesoterodine|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006976|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006945|NCT00798434|O1|Outcome|Placebo/Fesoterodine|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). During study, participants permitted 1 dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006946|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006947|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006948|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006949|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006950|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006951|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006952|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006953|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006954|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006955|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006956|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006957|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006958|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006959|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006960|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006961|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006962|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006963|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006964|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006965|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006966|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006967|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006968|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006969|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006970|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006971|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006972|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006973|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006974|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006975|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006977|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006978|NCT00798434|O2|Outcome|Fesoterodine|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded) with 1 permitted dose increase to fesoterodine 8 mg daily (and 1 decrease from 8 mg back to 4 mg, if necessary).
1006979|NCT00798434|O1|Outcome|Placebo|Participants received matched placebo once daily from baseline to Week 12 (double-blinded) with 1 permitted sham dose increase (and 1 sham decrease if necessary).
1006980|NCT00798434|E4|Reported Event|Placebo/Fesoterodine Open-label|Participants received 12 weeks of matched placebo (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). SAEs and non-serious AEs reported for these participants only during the open-label phase.
1006981|NCT00798434|E3|Reported Event|Festerodine/Fesoterodine Open-Label|Participants received 12 weeks of fesoterodine 4 mg once daily (double-blinded), followed by 12 weeks of fesoterodine 4 mg once daily (open-label). Serious adverse events (SAEs) and non-serious adverse events (AEs) reported reported for these participants only during the open-label phase.
1006982|NCT00798434|E2|Reported Event|Fesoterodine Double-Blind|Participants received fesoterodine 4 mg once daily from baseline to Week 12 (double-blinded)
1006983|NCT00798434|E1|Reported Event|Placebo Double-Blind|Participants received matched placebo once daily from baseline to Week 12 (double-blinded)
1006984|NCT00798369|B7|Baseline|Total|Total of all reporting groups
1006985|NCT00798369|B6|Baseline|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1006986|NCT00798369|B5|Baseline|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006987|NCT00798369|B4|Baseline|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006988|NCT00798369|B3|Baseline|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006989|NCT00798369|B2|Baseline|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006990|NCT00798369|B1|Baseline|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006991|NCT00798369|P6|Participant Flow|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1006992|NCT00798369|P5|Participant Flow|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006993|NCT00798369|P4|Participant Flow|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006994|NCT00798369|P3|Participant Flow|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006995|NCT00798369|P2|Participant Flow|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006996|NCT00798369|P1|Participant Flow|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1006997|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1006998|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007079|NCT00798304|E3|Reported Event|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1006999|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007000|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007001|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007002|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007003|NCT00798369|O1|Outcome|Linear Model|The linear model was the best-fitting model out of the 4 selected models (Emax, Logistic, Linear in Log-dose, Linear)with lowest Akaike Information Criterion (AIC).
1007004|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1007005|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007006|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007007|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007008|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007009|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007010|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1007011|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007012|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007013|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007014|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007015|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007016|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1007017|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007083|NCT00798161|B7|Baseline|L2.5+M1000BID (Open Label)|Open label set: Linagliptin 2.5mg + Metformin 1000mg BID
1007018|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007019|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007020|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007021|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007022|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1007023|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007024|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007025|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007026|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007027|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007028|NCT00798369|O6|Outcome|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1007029|NCT00798369|O5|Outcome|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007030|NCT00798369|O4|Outcome|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007031|NCT00798369|O3|Outcome|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007032|NCT00798369|O2|Outcome|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007033|NCT00798369|O1|Outcome|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007034|NCT00798369|E6|Reported Event|Triamcinolone Acetonide 40 mg|Triamcinolone acetonide 40 mg intramuscularly (i.m) once. The i.m. injection was recommended to be administered deeply into the gluteal muscle. Randomized patients received triamcinolone acetonide 40 mg i.m. once or canakinumab matching placebo once, on Day 1.
1007035|NCT00798369|E5|Reported Event|Canakinumab 150 mg|Canakinumab 150 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007080|NCT00798304|E2|Reported Event|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007081|NCT00798304|E1|Reported Event|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007036|NCT00798369|E4|Reported Event|Canakinumab 90 mg|Canakinumab 90 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007037|NCT00798369|E3|Reported Event|Canakinumab 50 mg|Canakinumab 50 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007038|NCT00798369|E2|Reported Event|Canakinumab 25 mg|Canakinumab 25 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007039|NCT00798369|E1|Reported Event|Canakinumab 10 mg|Canakinumab 10 mg subcutaneous (s.c) once. The s.c. injection could be administered into the arm or thigh. Randomized patients received one s.c. injection of canakinumab and placebo matching triamcinolone acetonide (0.9% sodium chloride) intramuscularly (i.m.) once,on Day 1. The i.m. injection was recommended to be administered deeply into the gluteal muscle.
1007040|NCT00798317|B3|Baseline|Total|Total of all reporting groups
1007041|NCT00798317|B2|Baseline|Placebo|Intravitreal injection of placebo
1007042|NCT00798317|B1|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
1007043|NCT00798317|P2|Participant Flow|Placebo|Intravitreal injection of placebo
1007044|NCT00798317|P1|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
1007045|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
1007046|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
1007047|NCT00798317|O2|Outcome|Placebo|Intravitreal injection of placebo
1007048|NCT00798317|O1|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection
1007049|NCT00798317|E2|Reported Event|Placebo|Intravitreal injection of placebo
1007050|NCT00798317|E1|Reported Event|Ocriplasmin 125ug|125ug ocriplasmin intravitreal injection
1007051|NCT00798304|B4|Baseline|Total|Total of all reporting groups
1007052|NCT00798304|B3|Baseline|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007053|NCT00798304|B2|Baseline|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007054|NCT00798304|B1|Baseline|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007055|NCT00798304|P3|Participant Flow|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007056|NCT00798304|P2|Participant Flow|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007057|NCT00798304|P1|Participant Flow|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007058|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007059|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007060|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007061|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007062|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007063|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007064|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007065|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007066|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007067|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007068|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007069|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007070|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007071|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007072|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007073|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007074|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007075|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007076|NCT00798304|O3|Outcome|rLP2086 60 mcg|rLP2086 60 mcg vaccine along with routine childhood vaccines according to local practice.
1007077|NCT00798304|O2|Outcome|rLP2086 20 mcg|Recombinant lipoprotein 2086 (rLP2086) 20 microgram (mcg) vaccine along with routine childhood vaccines according to local practice.
1007078|NCT00798304|O1|Outcome|Control|Routine childhood vaccines (InfanrixHexa, Meningitec, Prevenar and Rotarix) according to local practice.
1007090|NCT00798161|P7|Participant Flow|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg BID
1007091|NCT00798161|P6|Participant Flow|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg BID
1007092|NCT00798161|P5|Participant Flow|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg BID
1007093|NCT00798161|P4|Participant Flow|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
1007094|NCT00798161|P3|Participant Flow|M1000 BID|Patients treated with Metformin 1000 mg BID
1007095|NCT00798161|P2|Participant Flow|M500 Twice Daily (BID)|Patients treated with Metformin 500 mg BID
1007096|NCT00798161|P1|Participant Flow|Placebo|Patients treated with matching placebo
1007097|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007098|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007099|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007100|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007101|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007102|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007103|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
1007104|NCT00798161|O1|Outcome|OL: L2.5+M1000BID|Open label set: Linagliptin 2.5mg + Metformin 1000mg twice daily (BID)
1007105|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007106|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007107|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007108|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007109|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007110|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007111|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007112|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007113|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007114|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007115|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007116|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007117|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007118|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007119|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007120|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007121|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007122|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007123|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007124|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007125|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007126|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007127|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007128|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007129|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007130|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007131|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007132|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007133|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007134|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007135|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007136|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007137|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007138|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007139|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007140|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007141|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007142|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007143|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007144|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007145|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007146|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007147|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007148|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007149|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007150|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007151|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007152|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007153|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007154|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007155|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007156|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007157|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007158|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007159|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007160|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007161|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007162|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007163|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007164|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007165|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007166|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007167|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007168|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007169|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007170|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007171|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007172|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007173|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007174|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007175|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007176|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007177|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007178|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007179|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007180|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007181|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007182|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007183|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007184|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007185|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007186|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007187|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007188|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007189|NCT00798161|O6|Outcome|L2.5+M1000BID|Patients treated with Linagliptin 2.5mg+ Metformin 1000mg BID
1007190|NCT00798161|O5|Outcome|L2.5+M500BID|Patients treated with Linagliptin 2.5mg+ Metformin 500mg BID
1007191|NCT00798161|O4|Outcome|Lina5|Patients treated with Linagliptin 5mg OD
1007192|NCT00798161|O3|Outcome|M1000BID|Patients treated with Metformin 1000mg BID
1007193|NCT00798161|O2|Outcome|M500BID|Patients treated with Metformin 500mg BID
1007194|NCT00798161|O1|Outcome|Placebo|Patients treated with matching placebo
1007195|NCT00798161|E7|Reported Event|OL: L2.5+M1000 BID|Open label set: Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
1007196|NCT00798161|E6|Reported Event|L2.5 + M1000 BID|Patients treated with Linagliptin 2.5 mg + Metformin 1000 mg bis in die (BID)
1007197|NCT00798161|E5|Reported Event|L2.5+M500 BID|Patients treated with Linagliptin 2.5 mg + Metformin 500 mg bis in die (BID)
1007198|NCT00798161|E4|Reported Event|Lina 5|Patients treated with Linagliptin 5 mg once daily (OD)
1007199|NCT00798161|E3|Reported Event|M1000 BID|Patients treated with Metformin 1000 mg bis in die (BID)
1007200|NCT00798161|E2|Reported Event|M500 BID|Patients treated with Metformin 500 mg BID
1007201|NCT00798161|E1|Reported Event|Placebo|Patients treated with matching placebo
1007202|NCT00798135|B1|Baseline|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
1007203|NCT00798135|P1|Participant Flow|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
1007204|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
1007205|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
1007206|NCT00798135|O1|Outcome|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
1007207|NCT00798135|E1|Reported Event|Itraconazole|oral itraconazole 200mg a day until disease progression or unacceptable toxicities.
1007208|NCT00798096|B1|Baseline|Overall Study|1-fostamatinib 200mg, BID, Oral
1007209|NCT00798096|P1|Participant Flow|Overall Study|1-fostamatinib 200mg, BID, Oral
1007210|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
1007211|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
1007212|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
1007213|NCT00798096|O1|Outcome|Overall Study|1-fostamatinib 200mg, BID, Oral
1007214|NCT00798096|E1|Reported Event|Overall Study|1-fostamatinib 200mg, BID, Oral
1007215|NCT00798018|B5|Baseline|Total|Total of all reporting groups
1007216|NCT00798018|B4|Baseline|Tetracaine|1% tetracaine was used to inflate the cuff
1007217|NCT00798018|B3|Baseline|Lidocaine|2% lidiocaine was used to inflate the cuff
1007218|NCT00798018|B2|Baseline|Normal Saline|normal saline was used to inflate the cuff
1007219|NCT00798018|B1|Baseline|Air Alone|Only air was injected into the cuff, as the routine practice
1007220|NCT00798018|P4|Participant Flow|Tetracaine|1% tetracaine was used to inflate the cuff
1007221|NCT00798018|P3|Participant Flow|Lidocaine|2% lidiocaine was used to inflate the cuff
1007222|NCT00798018|P2|Participant Flow|Normal Saline|normal saline was used to inflate the cuff
1007223|NCT00798018|P1|Participant Flow|Air Alone|Only air was injected into the cuff, as the routine practice
1007224|NCT00798018|O4|Outcome|Tetracaine|1% tetracaine was used to inflate the cuff
1007225|NCT00798018|O3|Outcome|Lidocaine|2% lidiocaine was used to inflate the cuff
1007226|NCT00798018|O2|Outcome|Normal Saline|normal saline was used to inflate the cuff
1007227|NCT00798018|O1|Outcome|Air Alone|Only air was injected into the cuff, as the routine practice
1007228|NCT00798018|E4|Reported Event|Tetracaine|1% tetracaine was used to inflate the cuff
1007229|NCT00798018|E3|Reported Event|Lidocaine|2% lidiocaine was used to inflate the cuff
1007230|NCT00798018|E2|Reported Event|Normal Saline|normal saline was used to inflate the cuff
1007231|NCT00798018|E1|Reported Event|Air Alone|Only air was injected into the cuff, as the routine practice
1007232|NCT00797966|B5|Baseline|Total|Total of all reporting groups
1007233|NCT00797966|B4|Baseline|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007234|NCT00797966|B3|Baseline|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007235|NCT00797966|B2|Baseline|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
1007236|NCT00797966|B1|Baseline|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007237|NCT00797966|P6|Participant Flow|Participants in Phase A+|Based on the response at Week 8 (in Phase A), participants were either randomized to Phase B or continued single-blind treatment in Phase A+. Participants who met the criteria for a response at Week 8 were not to be randomized into Phase B but continued to receive single-blind placebo plus the maximum tolerated dose of ADT from Week 8 for an additional 6 weeks in Phase A+.
1007238|NCT00797966|P5|Participant Flow|Participants in Phase A|Participants entered Phase A (single-blind prospective treatment) during which participants had received single-blind placebo plus an open-label commercially available ADT for 8 weeks at maximally tolerated doses.
1007239|NCT00797966|P4|Participant Flow|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007240|NCT00797966|P3|Participant Flow|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007241|NCT00797966|P2|Participant Flow|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007242|NCT00797966|P1|Participant Flow|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007243|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007244|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007245|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
1007246|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007247|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007248|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007249|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007250|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007251|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007252|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007253|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007254|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007255|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007256|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007257|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
1007258|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007259|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007260|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007261|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
1007262|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007263|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007264|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007265|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007266|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007267|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007268|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007269|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007270|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007271|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007272|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007273|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007274|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007275|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007276|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007277|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007278|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007279|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007280|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007281|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007282|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007283|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination
1007284|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007285|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007286|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007287|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007288|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007289|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007290|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007291|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007292|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007293|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007294|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007295|NCT00797966|O4|Outcome|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007296|NCT00797966|O3|Outcome|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007297|NCT00797966|O2|Outcome|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007298|NCT00797966|O1|Outcome|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007299|NCT00797966|E4|Reported Event|Placebo|The participants received double-blind placebo as an adjunctive therapy along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007300|NCT00797966|E3|Reported Event|OPC-34712 1.5 ± 0.5 mg High Dose|The participants received 1.5 mg OPC-34712, then 1.5 ± 0.50 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007301|NCT00797966|E2|Reported Event|OPC-34712 0.5 ± 0.25 mg Low Dose|The participants received 0.50 mg OPC-34712, then 0.50 ± 0.25 mg/day along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007302|NCT00797966|E1|Reported Event|OPC-34712 0.15 mg Fixed Dose|The participants received 0.15 mg/day OPC-34712 along with the physician assigned ADT from Week 9 to Week 14/ Early Termination.
1007303|NCT00797862|B4|Baseline|Total|Total of all reporting groups
1007304|NCT00797862|B3|Baseline|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007305|NCT00797862|B2|Baseline|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007306|NCT00797862|B1|Baseline|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007307|NCT00797862|P3|Participant Flow|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007308|NCT00797862|P2|Participant Flow|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007309|NCT00797862|P1|Participant Flow|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007310|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007311|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007312|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007313|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007314|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007315|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007316|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007317|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007318|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007319|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007320|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007321|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007322|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007323|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007370|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007324|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007325|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007326|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007327|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007328|NCT00797862|O3|Outcome|Amlodipine Start-Aliskiren Add On|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure > 140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007329|NCT00797862|O2|Outcome|Aliskiren Start-Amlodipine Add On|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007330|NCT00797862|O1|Outcome|Aliskiren+Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007331|NCT00797862|E3|Reported Event|Amlodipine|Eligible participants received oral amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of amlodipine increased to 10 mg daily. From week 16-24, aliskiren 300 mg was added to the amlodipine 10 mg for 8 weeks (amlodipine 10 mg + aliskiren 300 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (amlodipine 10 mg + aliskiren 300 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007332|NCT00797862|E2|Reported Event|Aliskiren|Eligible participants received oral aliskiren 150 mg daily from week 1-8. From week 8 - 16, the dose of aliskiren increased to 300 mg daily. From week 16-24, amlodipine 10 mg was added to the aliskiren 300 mg for 8 weeks (aliskiren 300 mg + amlodipine 10 mg). At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007333|NCT00797862|E1|Reported Event|Aliskiren + Amlodipine|Eligible participants received oral aliskiren 150 mg + amlodipine 5 mg daily from week 1-8. From week 8 - 16, the dose of the combination treatment increased to aliskiren 300 mg + amlodipine 10 mg daily. From week 16-24, participants in this group continued combination treatment (aliskiren 300 mg + amlodipine 10 mg) for 8 weeks. At week 24, if blood pressure was not adequately controlled (systolic blood pressure >140 mmHg or diastolic blood pressure >90 mmHg) hydrochlorothiazide 12.5 mg was added to the combination (aliskiren 300 mg + amlodipine 10 mg) for an additional 8 weeks. Total treatment period =32 weeks.
1007334|NCT00797823|B4|Baseline|Total|Total of all reporting groups
1007335|NCT00797823|B3|Baseline|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
1007336|NCT00797823|B2|Baseline|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
1007371|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007372|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007707|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007337|NCT00797823|B1|Baseline|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
1007338|NCT00797823|P3|Participant Flow|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
1007339|NCT00797823|P2|Participant Flow|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
1007340|NCT00797823|P1|Participant Flow|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
1007341|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
1007342|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
1007343|NCT00797823|O2|Outcome|Active Comparator: Insulin Plus Glucagon|Insulin plus glucagon given (latter to prevent hypoglycemia) for closed loop control.
1007344|NCT00797823|O1|Outcome|Placebo Comparator: Insulin Alone|No glucagon given during closed loop control-insulin only
1007345|NCT00797823|E3|Reported Event|Pilot|Pilot studies included 6 participants, one of whom underwent an insulin + glucagon and an insulin + placebo study, while 5 underwent only one insulin + glucagon study.
1007346|NCT00797823|E2|Reported Event|Insulin + Placebo -> Insulin + Glucagon|This group consists of x participants initially randomized to the insulin plus placebo intervention for glycemic control of type 1 diabetes during the first period, then insulin plus glucagon (latter to prevent hypoglycemia) in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
1007347|NCT00797823|E1|Reported Event|Insulin + Glucagon -> Insulin + Placebo)|This group consists of x participants initially randomized to the insulin plus glucagon (latter to prevent hypoglycemia) intervention for glycemic control of type 1 diabetes during the first period, then insulin plus placebo in the second period. The control system was comprised of glucose sensors, a computer algorithm, and actuator pumps in a circuit meant to automatically adjust insulin and glucagon infusion rates based on glucose values delivered to the algorithm (a closed-loop system, as it is meant to exclude human intervention).
1007348|NCT00797797|B3|Baseline|Total|Total of all reporting groups
1007349|NCT00797797|B2|Baseline|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
1007350|NCT00797797|B1|Baseline|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
1007351|NCT00797797|P2|Participant Flow|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
1007352|NCT00797797|P1|Participant Flow|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
1007353|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
1007354|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
1007355|NCT00797797|O2|Outcome|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
1007356|NCT00797797|O1|Outcome|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
1007357|NCT00797797|E2|Reported Event|Milnacipran Added|Milnacipran (100 mg/day) added for 11 weeks of randomized treatment period
1007358|NCT00797797|E1|Reported Event|No Treatment Added|No treatment added for 11 weeks of randomized treatment period
1007359|NCT00797667|B4|Baseline|Total|Total of all reporting groups
1007360|NCT00797667|B3|Baseline|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007361|NCT00797667|B2|Baseline|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007362|NCT00797667|B1|Baseline|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007363|NCT00797667|P3|Participant Flow|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007364|NCT00797667|P2|Participant Flow|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007365|NCT00797667|P1|Participant Flow|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007366|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007367|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007368|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007369|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1008246|NCT00795886|O1|Outcome|Rate of Transplant Related Mortality|All participants enrolled in the trial
1007373|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007374|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007375|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007376|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007377|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007378|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007379|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007380|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007381|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007382|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007383|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007384|NCT00797667|O3|Outcome|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007385|NCT00797667|O2|Outcome|Telcagepant 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007386|NCT00797667|O1|Outcome|Telcagepant 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007387|NCT00797667|E3|Reported Event|Placebo|Participants receive one 140 mg telcagepant placebo and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007388|NCT00797667|E2|Reported Event|MK-0974 280 mg|Participants receive one telcagepant 280 mg tablet and one 140 mg telcagepant placebo, orally, twice daily for 12 weeks
1007389|NCT00797667|E1|Reported Event|MK-0974 140 mg|Participants receive one telcagepant 140 mg tablet and one 280 mg telcagepant placebo, orally, twice daily for 12 weeks
1007390|NCT00797563|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
1007391|NCT00797563|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
1007392|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
1007393|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
1007394|NCT00797563|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
1007395|NCT00797563|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system (BGMS) with capillary blood; healthcare professionals use the new BGMS with subject capillary and venous blood.
1007396|NCT00797511|B1|Baseline|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
1007397|NCT00797511|P1|Participant Flow|ADACEL POLIO Vaccine Study Group|Participants received one dose of TdcP-IPV vaccine (ADACEL Polio) on Day 0.
1007398|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
1007399|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
1007400|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
1007401|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received a dose of Tdap or Tdap-vIPV vaccine on Day 0
1007402|NCT00797511|O1|Outcome|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
1007403|NCT00797511|E1|Reported Event|ADACEL POLIO Vaccine Study Group|Participants received one dose of Tetanus, diphtheria (reduced antigen content), pertussis (acellular components) vaccine (TdcP-IPV, ADACEL Polio) on Day 0
1007404|NCT00797459|B1|Baseline|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
1007405|NCT00797459|P1|Participant Flow|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
1007406|NCT00797459|O2|Outcome|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
1007407|NCT00797459|O1|Outcome|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
1007408|NCT00797459|O2|Outcome|Restylane-L|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
1007409|NCT00797459|O1|Outcome|Restylane|Split-face design with each subject receiving Restylane on one side of the face and Restylane with Lidocaine (Restylane-L) on the other. Injection frequency is once on day 1.
1020859|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1007410|NCT00797459|E2|Reported Event|Restylane Side of Face|The Restylane gel side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
1007411|NCT00797459|E1|Reported Event|Restylane-L Side of Face|Restylane with Lidocaine gel(Restylane-L) side of the face. Injection occurs on Day 1 only. Injection amount is determined by achieving the optimal cosmetic results (variable).
1007412|NCT00797316|B3|Baseline|Total|Total of all reporting groups
1007413|NCT00797316|B2|Baseline|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007414|NCT00797316|B1|Baseline|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007415|NCT00797316|P2|Participant Flow|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007416|NCT00797316|P1|Participant Flow|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007417|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007418|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007419|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007420|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007421|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007422|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007423|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007424|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007425|NCT00797316|O2|Outcome|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007426|NCT00797316|O1|Outcome|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007427|NCT00797316|E2|Reported Event|Aliskiren|Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.
1007428|NCT00797316|E1|Reported Event|Aliskiren/HCTZ|Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
1007429|NCT00797277|B3|Baseline|Total|Total of all reporting groups
1007430|NCT00797277|B2|Baseline|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
1007431|NCT00797277|B1|Baseline|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
1007432|NCT00797277|P2|Participant Flow|2. IM Haloperidol Plus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
1007433|NCT00797277|P1|Participant Flow|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization. The patients could receive a maximum of 3 injections within the 24-hour period. Second and third injections were prescribed at the discretion of the clinical investigators. A second injection was allowed after 2 hours had elapsed since the first injection. A third injection was allowed after 4 hours had passed since the second injection.
1007434|NCT00797277|O2|Outcome|2. IM Haloperidol Pus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
1007435|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
1007436|NCT00797277|O2|Outcome|2. IM Haloperidol Plus Lorazepam|5 mg haloperidol plus 2 mg lorazepam IM injection
1007437|NCT00797277|O1|Outcome|1. IM Olanzapine|10 mg olanzapine IM injection
1007438|NCT00797277|E2|Reported Event|2. IM Haloperidol Pus Lorazepam|Patients of this arm received 5 mg IM haloperidol plus 2 mg IM lorazepam after randomization
1007439|NCT00797277|E1|Reported Event|1. IM Olanzapine|Patients of this arm received 10 mg IM olanzapine after randomization
1007440|NCT00797212|B1|Baseline|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm
1007441|NCT00797212|P1|Participant Flow|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
1007442|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
1007443|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
1007444|NCT00797212|O1|Outcome|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
1007445|NCT00797212|E1|Reported Event|Subjects With Diabetes|Subjects with diabetes use a new blood glucose monitoring system with blood obtained from the palm and forearm.
1007446|NCT00797108|B4|Baseline|Total|Total of all reporting groups
1007769|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1007447|NCT00797108|B3|Baseline|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007448|NCT00797108|B2|Baseline|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007449|NCT00797108|B1|Baseline|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007450|NCT00797108|P3|Participant Flow|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007451|NCT00797108|P2|Participant Flow|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007452|NCT00797108|P1|Participant Flow|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007453|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007454|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007455|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007456|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007511|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1020860|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1007457|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007458|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007459|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007460|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007461|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007462|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007463|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007464|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007465|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007466|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007523|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007827|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007467|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007468|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007469|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007470|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007471|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007472|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007473|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007474|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007475|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007476|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007535|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007477|NCT00797108|O3|Outcome|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007478|NCT00797108|O2|Outcome|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007479|NCT00797108|O1|Outcome|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007480|NCT00797108|E3|Reported Event|Ceftriaxone and Amoxicillin/Clavulanate|Ceftriaxone 2 gram (g) intravenous infusion over 30 minutes once daily for minimum of 2 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 1 hour twice daily for minimum of 4 doses. After in-patient period, stepped down to oral amoxicillin/clavulanate potassium suspension (800 mg/10 milliliter) twice daily along with oral placebo tablets twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007481|NCT00797108|E2|Reported Event|Sulopenem (Multi Intravenous Dose) and PF-03709270|Sulopenem 600 mg intravenous infusion over 1 hour twice daily for minimum of 4 doses, followed by oral placebo tablets 12 hours after first intravenous dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion) along with placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007482|NCT00797108|E1|Reported Event|Sulopenem (Single Intravenous Dose) and PF-03709270|Single loading dose of sulopenem 600 milligram (mg) intravenous infusion over 1 hour, followed by oral PF-03709270 (5*200 mg tablets) 12 hours after loading dose, twice daily during in-patient period (minimum of 2 days equivalent on intravenous dose or as per investigator’s discretion), along with placebo intravenous infusion over 1 hour and then twice daily for minimum of 3 doses, followed by placebo intravenous infusion over 30 minutes once daily for minimum of 2 doses. After in-patient period, switched to oral PF-03709270 1000 mg (5*200 mg tablets) twice daily along with oral placebo suspension twice daily. Total treatment duration of 7 to 10 days was at the discretion of the investigator.
1007483|NCT00796991|B4|Baseline|Total|Total of all reporting groups
1007484|NCT00796991|B3|Baseline|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007485|NCT00796991|B2|Baseline|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007486|NCT00796991|B1|Baseline|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007487|NCT00796991|P3|Participant Flow|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007488|NCT00796991|P2|Participant Flow|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007708|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007489|NCT00796991|P1|Participant Flow|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007490|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007491|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007492|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007493|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007494|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007495|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007496|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007497|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007498|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007499|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007547|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007709|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007500|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007501|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007502|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007503|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007504|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007505|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007506|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007507|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007508|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007509|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007510|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007710|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1008247|NCT00795886|E1|Reported Event|Rapamycin|This includes all study participants.
1007512|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007513|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007514|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007515|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007516|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007517|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007518|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007519|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007520|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007521|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007522|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007711|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007828|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007524|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007525|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007526|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007527|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007528|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007529|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007530|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007531|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007532|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007533|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007534|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007712|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007829|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007536|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007537|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007538|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007539|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007540|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007541|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007542|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007543|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007544|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007545|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007546|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007713|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007830|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007548|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007549|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007550|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007551|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007552|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007553|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007554|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007555|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007556|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007557|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007558|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007714|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1008547|NCT00795132|O3|Outcome|Unrelated Cord Blood|Unrelated donor: Cord Blood
1007559|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007560|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007561|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007562|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007563|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007564|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007565|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007566|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007567|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007568|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007569|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007609|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007610|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007570|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007571|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007572|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007573|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007574|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007575|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007576|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007577|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007578|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007579|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007580|NCT00796991|O3|Outcome|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007611|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007715|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1008835|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1007581|NCT00796991|O2|Outcome|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007582|NCT00796991|O1|Outcome|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007583|NCT00796991|E3|Reported Event|Ipilimumab|Induction Phase: Participant received ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes every 3 weeks for up to 4 doses (Week 1 Day 1, and Weeks 4, 7, and 10). Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007584|NCT00796991|E2|Reported Event|Dacarbazine, Ipilimumab|Induction Phase: Participant received dacarbazine 850 mg/m^2 IV by a 1-hour infusion on Day 1 (Week 1, Day 1) and ipilimumab at a dose of 10 mg/kg IV administered over 90 minutes on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10 and dacarbazine at Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the dacarbazine infusion. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007585|NCT00796991|E1|Reported Event|Paclitaxel, Carboplatin, Ipilimumab|Induction Phase: Participant received paclitaxel 175 mg/m^2 intravenously (IV) by a 3-hour infusion and carboplatin IV by a 30-minute infusion) on Day 1 (Week 1, Day 1) and ipilimumab 10 mg/kg IV administered on Day 3 (Week 1, Day 3). Ipilimumab was administered at Weeks 4, 7, and 10, and paclitaxel/carboplatin were administered every 3 weeks (Weeks 4, 7, 10, 13, 16, 19, and 22), with participants receiving the ipilimumab infusion first, followed by the paclitaxel and then carboplatin infusions. A maximum of 8 doses of chemotherapy was permitted. Maintenance Phase: Ipilimumab was administered at a dose of 10 mg/kg every 12 Weeks, beginning at Week 24, until disease progression, study drug-associated toxicity, withdrawal of consent or study closure.
1007586|NCT00796926|B3|Baseline|Total|Total of all reporting groups
1007587|NCT00796926|B2|Baseline|Refresh|Four times a day for 6 weeks in each eye
1007588|NCT00796926|B1|Baseline|Systane Ultra|four times a day for six weeks in each eye
1007589|NCT00796926|P2|Participant Flow|Refresh|Four times a day for 6 weeks in each eye
1007590|NCT00796926|P1|Participant Flow|Systane Ultra|four times a day for six weeks in each eye
1007591|NCT00796926|O2|Outcome|Refresh|Four times a day for 6 weeks in each eye
1007592|NCT00796926|O1|Outcome|Systane Ultra|four times a day for six weeks in each eye
1007593|NCT00796926|E2|Reported Event|Refresh|Four times a day for 6 weeks in each eye
1007594|NCT00796926|E1|Reported Event|Systane Ultra|four times a day for six weeks in each eye
1007595|NCT00796822|B3|Baseline|Total|Total of all reporting groups
1007596|NCT00796822|B2|Baseline|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
1007597|NCT00796822|B1|Baseline|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
1007598|NCT00796822|P2|Participant Flow|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
1007599|NCT00796822|P1|Participant Flow|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
1007600|NCT00796822|O2|Outcome|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
1007601|NCT00796822|O1|Outcome|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
1007602|NCT00796822|E2|Reported Event|Placebo|"Participants will receive placebo.~Placebo : One pill three times a day for 8 weeks"
1007603|NCT00796822|E1|Reported Event|Pentoxifylline|"Participants will receive pentoxifylline.~Pentoxifylline : 400 mg three times a day for 8 weeks"
1007604|NCT00796757|B1|Baseline|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007605|NCT00796757|P1|Participant Flow|Bevacizumab Plus (+) Interferon|Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007606|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007607|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007608|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007706|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007612|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007613|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007614|NCT00796757|O1|Outcome|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007615|NCT00796757|E1|Reported Event|Bevacizumab + Interferon|Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
1007616|NCT00796744|B4|Baseline|Total|Total of all reporting groups
1007617|NCT00796744|B3|Baseline|0.01% DSC127|0.01% DSC127 in Vehicle Control
1007618|NCT00796744|B2|Baseline|0.03 % DSC127|0.03% DSC127 in Vehicle Control
1007619|NCT00796744|B1|Baseline|Placebo Vehicle Control|control placebo vehicle
1007620|NCT00796744|P3|Participant Flow|0.01% DSC127|0.01% DSC127 in Vehicle Control
1007621|NCT00796744|P2|Participant Flow|0.03 % DSC127|0.03% DSC127 in Vehicle Control
1007622|NCT00796744|P1|Participant Flow|Placebo Vehicle Control|control placebo vehicle
1007623|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
1007624|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
1007625|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
1007626|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
1007627|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
1007628|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
1007629|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
1007630|NCT00796744|O2|Outcome|0.03 % DSC127|0.03% DSC127 in Vehicle Control
1007631|NCT00796744|O1|Outcome|Placebo Vehicle Control|control placebo vehicle
1007632|NCT00796744|O3|Outcome|0.01% DSC127|0.01% DSC127 in Vehicle Control
1007633|NCT00796744|O2|Outcome|0.03% DSC127|0.03% DSC127 in Vehicle Control
1007634|NCT00796744|O1|Outcome|Placebo|control placebo vehicle
1007635|NCT00796744|E3|Reported Event|0.01% DSC127|0.01% DSC127 in Vehicle Control
1007636|NCT00796744|E2|Reported Event|0.03 % DSC127|0.03% DSC127 in Vehicle Control
1007637|NCT00796744|E1|Reported Event|Placebo Vehicle Control|control placebo vehicle
1007638|NCT00796718|B1|Baseline|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
1007639|NCT00796718|P1|Participant Flow|Capecitabine|Capecitabine 825 milligrams per meter square (mg/m^2) orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
1007640|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
1007641|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
1007642|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
1007643|NCT00796718|O1|Outcome|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
1007644|NCT00796718|E1|Reported Event|Capecitabine|Capecitabine 825 mg/m^2 orally twice daily plus standard radiotherapy for 5 weeks as prescribed according to normal clinical practice, followed by surgery within 6 weeks after completion of treatment.
1007645|NCT00796705|B5|Baseline|Total|Total of all reporting groups
1007646|NCT00796705|B4|Baseline|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007647|NCT00796705|B3|Baseline|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007648|NCT00796705|B2|Baseline|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007649|NCT00796705|B1|Baseline|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1020861|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1007650|NCT00796705|P4|Participant Flow|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007651|NCT00796705|P3|Participant Flow|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007652|NCT00796705|P2|Participant Flow|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007653|NCT00796705|P1|Participant Flow|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007654|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007655|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007656|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007657|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007658|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007659|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007660|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007661|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007662|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007663|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007664|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007665|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007666|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007667|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007668|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007669|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007670|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007671|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007672|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007673|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007674|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007675|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007676|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007677|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1008836|NCT00793910|E2|Reported Event|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1007678|NCT00796705|O4|Outcome|Switcher/Etanercept to Adalimumab Alternating With Placebo|"Participants defined as etanercept failures [1] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007679|NCT00796705|O3|Outcome|Switcher/Adalimumab to Etanercept|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007680|NCT00796705|O2|Outcome|Non-Switcher/Etanercept|"Participants defined as etanercept failures [1] at screening who were randomized to receive etanercept (one 50 mg subcutaneous injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007681|NCT00796705|O1|Outcome|Non-Switcher/Adalimumab Alternating With Placebo|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~[1] Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab."
1007682|NCT00796705|O2|Outcome|Switcher/ Adalimumab to Etanercept or Etanercept to Adalimuma|"Participants defined as adalimumab failures [1]at screening who were randomized to switch from adalimumab to etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) treatment fashion and participants defined as etanercept failures [2] at screening who were randomized to switch from etanercept to adalimumab (one 40 mg SQ injection) alternating with adalimumab placebo (1.0 mL SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007683|NCT00796705|O1|Outcome|Non-Switcher/ Adalimumab or Etanercept|"Participants defined as adalimumab failures [1] at screening who were randomized to remain on adalimumab (one 40 milligram [mg] subcutaneous [SQ] injection) alternating with adalimumab placebo (1.0 millilitre [mL] SQ injection of normal saline 0.9%) once weekly for a total of 12 weeks in a blinded (masked) fashion and participants defined as etanercept failures [2] at screening who were randomized to receive etanercept (one 50 mg SQ injection) once weekly for a total of 12 weeks in a blinded (masked) fashion.~Adalimumab failures: participants with rheumatoid arthritis [RA] on adalimumab treatment for at least 12 weeks prior to treatment randomization that experienced inadequate clinical response to adalimumab.~Etanercept failures: participants with rheumatoid arthritis [RA] on etanercept treatment for at least 12 weeks prior to randomization that experienced inadequate clinical response to etanercept."
1007684|NCT00796705|E4|Reported Event|Switcher/Etanercept to Adalimumab|Subjects failing Etanercept at screening who were randomized to switch to Adalimumab
1007685|NCT00796705|E3|Reported Event|Switcher/Adalimumab to Etanercept|Subjects failing Adalimumab at screening who were randomized to switch to Etanercept
1007686|NCT00796705|E2|Reported Event|Non-Switcher/Etanercept|Subjects failing Etanercept at screening who were randomized to remain on Etanercept
1007687|NCT00796705|E1|Reported Event|Non-Switcher/Adalimumab|Subjects failing Adalimumab at screening who were randomized to remain on Adalimumab
1007688|NCT00796666|B3|Baseline|Total|Total of all reporting groups
1007689|NCT00796666|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007690|NCT00796666|B1|Baseline|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007691|NCT00796666|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007692|NCT00796666|P1|Participant Flow|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007693|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007694|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007695|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007696|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007697|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007698|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007699|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007700|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007701|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007702|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007703|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007704|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007705|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007716|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007717|NCT00796666|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007718|NCT00796666|O1|Outcome|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007719|NCT00796666|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan sodium (100 mg) orally once daily and sildenafil citrate (20 mg) TID
1007720|NCT00796666|E1|Reported Event|Sitaxsentan and Placebo|Sitaxsentan sodium (100 milligrams [mg]) orally once daily and placebo orally three times a day (TID)
1007721|NCT00796653|B5|Baseline|Total|Total of all reporting groups
1007722|NCT00796653|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007723|NCT00796653|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007724|NCT00796653|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007725|NCT00796653|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007726|NCT00796653|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007727|NCT00796653|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007728|NCT00796653|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007729|NCT00796653|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007730|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007731|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007732|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007733|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007734|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007735|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007736|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007737|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007738|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007739|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007740|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007741|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007742|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007743|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007744|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007745|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007746|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007747|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007748|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007749|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007750|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007751|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007752|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007753|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007754|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
1007755|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
1007756|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1007757|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1007758|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1007759|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1007760|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1007761|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1007762|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
1007763|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
1007764|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1007765|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1007766|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1007767|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1007768|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1008837|NCT00793910|E1|Reported Event|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1007770|NCT00796653|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
1007771|NCT00796653|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
1007772|NCT00796653|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1007773|NCT00796653|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1007774|NCT00796653|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1007775|NCT00796653|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1007776|NCT00796653|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1007777|NCT00796653|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1007778|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007779|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007780|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007781|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007782|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007783|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007784|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007785|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007786|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007787|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007788|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007789|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007790|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007791|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007792|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007793|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007794|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007795|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007796|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007797|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007798|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007799|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007800|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007801|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007802|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007803|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007804|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007805|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007806|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007807|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007808|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007809|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007810|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007811|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007812|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007813|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007814|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007815|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007816|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007817|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007818|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007819|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007820|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007821|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007822|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007823|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007824|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007825|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007826|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1020862|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1007831|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007832|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007833|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007834|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007835|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007836|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007837|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007838|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007839|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007840|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007841|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007842|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007843|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007844|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007845|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007846|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007847|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007848|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007849|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007850|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007851|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007852|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007853|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007854|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007855|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007856|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007857|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007858|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007859|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007860|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007861|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007862|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007863|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007864|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007865|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007866|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007867|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007868|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007869|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007870|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007871|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007872|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007873|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007874|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007875|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007876|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007877|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007878|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007879|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007880|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007881|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007882|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007883|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007884|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007885|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007886|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007887|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007888|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007889|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007890|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007891|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007892|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007893|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007894|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007895|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007896|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007897|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007898|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007899|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007900|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007901|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007902|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007903|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007904|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007905|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007906|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007907|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007908|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007909|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007910|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007911|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007912|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007913|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007914|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007915|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007916|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007917|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007918|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007919|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007920|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007921|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007922|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007923|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007924|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007925|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007926|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007927|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007928|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007929|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007930|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007931|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007932|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007933|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007934|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007935|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007936|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007937|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007938|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007939|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007940|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007941|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007942|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007943|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007944|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007945|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007946|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007947|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007948|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007949|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007950|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007951|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007952|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007953|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007954|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007955|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007956|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007957|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007958|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007959|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007960|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007961|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007962|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007963|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007964|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007965|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007966|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007967|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007968|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007969|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007970|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007971|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007972|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007973|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007974|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007975|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007976|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007977|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007978|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007979|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007980|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007981|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007982|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007983|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007984|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007985|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007986|NCT00796653|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007987|NCT00796653|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007988|NCT00796653|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007989|NCT00796653|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007990|NCT00796653|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1007991|NCT00796653|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1007992|NCT00796653|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1007993|NCT00796653|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1007994|NCT00796614|B5|Baseline|Total|Total of all reporting groups
1007995|NCT00796614|B4|Baseline|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1007996|NCT00796614|B3|Baseline|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1007997|NCT00796614|B2|Baseline|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1007998|NCT00796614|B1|Baseline|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008054|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1007999|NCT00796614|P4|Participant Flow|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008000|NCT00796614|P3|Participant Flow|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008001|NCT00796614|P2|Participant Flow|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008002|NCT00796614|P1|Participant Flow|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008003|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008004|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008005|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008006|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008007|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008008|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008009|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008010|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008011|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008012|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008013|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008014|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008015|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008107|NCT00796367|O1|Outcome|Placebo|Placebo
1008108|NCT00796367|E3|Reported Event|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
1008016|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008017|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008018|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008019|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008020|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008021|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008022|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008023|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008024|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008025|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008026|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008027|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008028|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008029|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008030|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008031|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008032|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008109|NCT00796367|E2|Reported Event|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
1008110|NCT00796367|E1|Reported Event|Placebo|Placebo
1008033|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008034|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008035|NCT00796614|O4|Outcome|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008036|NCT00796614|O3|Outcome|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008037|NCT00796614|O2|Outcome|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008038|NCT00796614|O1|Outcome|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008039|NCT00796614|E4|Reported Event|Tamsulosin - High Dose Level|Subjects were orally administered to high dose level (0.004 – 0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008040|NCT00796614|E3|Reported Event|Tamsulosin - Medium Dose Level|Subjects were orally administered to medium dose level (0.002 – 0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008041|NCT00796614|E2|Reported Event|Tamsulosin - Low Dose Level|Subjects were orally administered to low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a patient's body weight (12.5 kg -100.0 kg), by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of applesauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008042|NCT00796614|E1|Reported Event|Placebo|Subjects were orally administered to matching placebo to tamsulosin hydrochloride, with once daily by sprinkling the content of 2 capsules over a single teaspoonful (5 mL) of apple sauce or yogurt, taken 30 minutes after meal / snack (breakfast). A teaspoonful of water was taken after ingesting the applesauce or yogurt.
1008043|NCT00796549|B1|Baseline|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008044|NCT00796549|P1|Participant Flow|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008045|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008046|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008047|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008048|NCT00796549|O2|Outcome|Afatinib 50mg 2nd Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 2nd line anti cancer treatment, indicating that they had received one prior anti cancer treatment with chemotherapy.
1008049|NCT00796549|O1|Outcome|Afatinib 50mg 1st Line|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors). Only Patients with 1st line anti cancer treatment, indicating that they had not received prior treatment with chemotherapy.
1008050|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008051|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008052|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008053|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008111|NCT00796328|B1|Baseline|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
1008055|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008056|NCT00796549|O1|Outcome|Afatinib 50mg|Afatinib 50mg film coated tablets was administered once daily as long as they were tolerated by patients, until disease progression (according to the response evaluation criteria in solid tumors)
1008057|NCT00796549|E1|Reported Event|Afatinib 50mg|Afatinib 50mg film coated tablets where administered once daily as long as they were tolerated by patients, until a disease progression (according to the response evaluation criteria in solid tumors)
1008058|NCT00796523|B3|Baseline|Total|Total of all reporting groups
1008059|NCT00796523|B2|Baseline|Control Videotape|videotape with normal newborn instruction
1008060|NCT00796523|B1|Baseline|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
1008061|NCT00796523|P2|Participant Flow|Control Videotape|videotape with normal newborn instruction
1008062|NCT00796523|P1|Participant Flow|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
1008063|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
1008064|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
1008065|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
1008066|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
1008067|NCT00796523|O2|Outcome|Control Videotape|videotape with normal newborn instruction
1008068|NCT00796523|O1|Outcome|Happiest Baby Videotape|videotape describing the Happiest Baby on the Block technique
1008069|NCT00796510|B3|Baseline|Total|Total of all reporting groups
1008070|NCT00796510|B2|Baseline|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
1008071|NCT00796510|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
1008072|NCT00796510|P2|Participant Flow|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
1008073|NCT00796510|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
1008074|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
1008075|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
1008076|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
1008077|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
1008078|NCT00796510|O2|Outcome|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
1008079|NCT00796510|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
1008080|NCT00796510|E2|Reported Event|Sitaxsentan and Sildenafil|Sitaxsentan 100 mg daily and sildenafil 20 mg orally three times a day
1008081|NCT00796510|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) orally once a day
1008082|NCT00796419|B3|Baseline|Total|Total of all reporting groups
1008083|NCT00796419|B2|Baseline|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
1008084|NCT00796419|B1|Baseline|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
1008085|NCT00796419|P2|Participant Flow|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 6% hetastarch every 8 hours for 5 days
1008086|NCT00796419|P1|Participant Flow|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250 milliliters (mL) 5% human albumin every 8 hours for 5 days
1008087|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
1008088|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
1008089|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
1008090|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
1008091|NCT00796419|O2|Outcome|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
1008092|NCT00796419|O1|Outcome|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
1008093|NCT00796419|E2|Reported Event|Intravenous 6% Hetastarch|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 6% hetastarch every 8 hours for 5 days
1008094|NCT00796419|E1|Reported Event|Intravenous 5% Human Albumin|Recipients of continuous infusion intravenous furosemide and administration of intravenous 250mL 5% human albumin every 8 hours for 5 days
1008095|NCT00796367|B4|Baseline|Total|Total of all reporting groups
1008096|NCT00796367|B3|Baseline|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
1008097|NCT00796367|B2|Baseline|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
1008098|NCT00796367|B1|Baseline|Placebo|Placebo
1008099|NCT00796367|P3|Participant Flow|VI-0521 Top|VI-0521 15 mg PHEN/92 mg TPM
1008100|NCT00796367|P2|Participant Flow|VI-0521 Mid|VI-0521 7.5 mg PHEN/46 mg TPM
1008101|NCT00796367|P1|Participant Flow|Placebo|Placebo
1008102|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
1008103|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
1008104|NCT00796367|O1|Outcome|Placebo|Placebo
1008105|NCT00796367|O3|Outcome|VI-0521 Top|VI-0521 15 mg phentermine/92 mg topiramate
1008106|NCT00796367|O2|Outcome|VI-0521 Mid|VI-0521 7.5 mg phentermine/46 mg topiramate
1008112|NCT00796328|P1|Participant Flow|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
1008113|NCT00796328|O1|Outcome|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
1008114|NCT00796328|E1|Reported Event|Phenylephrine Infusion|Phenylephrine infusion : Up-down, biased coin design
1008115|NCT00796315|B1|Baseline|Doxylamine Succinate USP|Doxylamine Succinate, United States Pharmacopeia (USP): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
1008116|NCT00796315|P3|Participant Flow|Subjects Aged 12-17 Years (Doxylamine Suc|Ages 12-17 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
1008117|NCT00796315|P2|Participant Flow|Aged 6-11 Years (Doxylamine Succinate|"Ages 6-11 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.~Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued."
1008118|NCT00796315|P1|Participant Flow|Subjects Aged 2-5 Years (Doxylamine Succinate)|Ages 2-5 years. Doxylamine Succinate USP : One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL.
1008119|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine Succinate USP
1008120|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
1008121|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
1008122|NCT00796315|O3|Outcome|Subjects Aged 12-17 Years|Ages 12-17 years. All subjects received a dose of 12.5 mg Doxylamine Succinate USP
1008123|NCT00796315|O2|Outcome|Subjects Aged 6-11 Years|Ages 6-11 years. Subjects received a dose of 4.17 or 6.25 or 8.33 or 10.42 mg Doxylamine Succinate USP (exact dose dependent upon body weight). Note: One subject (age group 6-11) was unable to meet protocol criteria (spit out a portion of his dosage) and was discontinued.
1008124|NCT00796315|O1|Outcome|Subjects Aged 2-5 Years|Ages 2-5 years. Subjects received a dose of either 3.125 or 4.17 mg Doxylamine Succinate USP (exact dose dependent upon body weight)
1008125|NCT00796315|E3|Reported Event|Subjects Aged 12-17 Years|Ages 12-17 years. Doxylamine succinate USP
1008126|NCT00796315|E2|Reported Event|Aged 6-11 Years|Ages 6-11 years. Doxylamine Succinate USP
1008127|NCT00796315|E1|Reported Event|Subjects Aged 2-5 Years|Ages 2-5 years. Doxylamine Succinate USP
1008128|NCT00796302|B3|Baseline|Total|Total of all reporting groups
1008129|NCT00796302|B2|Baseline|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
1008130|NCT00796302|B1|Baseline|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
1008131|NCT00796302|P2|Participant Flow|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
1008132|NCT00796302|P1|Participant Flow|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
1008133|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
1008134|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
1008135|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
1008136|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
1008137|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
1008138|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
1008139|NCT00796302|O2|Outcome|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and risperidone. Parents will receive parent management training
1008140|NCT00796302|O1|Outcome|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
1008141|NCT00796302|E2|Reported Event|Augmented (Stimulant + PMT + Risperidone)|Children will receive active methylphenidate HCl and active risperidone. Parents will receive parent management training.
1008142|NCT00796302|E1|Reported Event|Basic (Stimulant + PMT + Placebo)|Children will receive active methylphenidate HCl and placebo. Parents will receive parent management training.
1008143|NCT00796224|B3|Baseline|Total|Total of all reporting groups
1008144|NCT00796224|B2|Baseline|30 mg/kg Azithromycin IR|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
1008145|NCT00796224|B1|Baseline|60 mg/kg Azithromycin ER|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
1008146|NCT00796224|P2|Participant Flow|30 mg/kg Azithromycin Immediate-release (IR)|Subjects received 30 mg/kg Azithromycin IR single oral dose on Day 1.
1008147|NCT00796224|P1|Participant Flow|60 mg/kg Azithromycin Extended-release (ER)|Subjects received 60 mg/kg Azithromycin ER single oral dose on Day 1.
1008148|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
1008149|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
1008150|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
1008151|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
1008152|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR (Reference)|
1008153|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER (Test)|
1008154|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
1008155|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
1008156|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
1008157|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
1008158|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
1008159|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
1008160|NCT00796224|O2|Outcome|30 mg/kg Azithromycin IR|
1008161|NCT00796224|O1|Outcome|60 mg/kg Azithromycin ER|
1008162|NCT00796224|E2|Reported Event|30 mg/kg Azithromycin IR|
1008163|NCT00796224|E1|Reported Event|60 mg/kg Azithromycin ER|
1008165|NCT00796120|B2|Baseline|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008166|NCT00796120|B1|Baseline|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008167|NCT00796120|P2|Participant Flow|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008168|NCT00796120|P1|Participant Flow|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008169|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008170|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008171|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008172|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008173|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008174|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008175|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008176|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008177|NCT00796120|O2|Outcome|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008178|NCT00796120|O1|Outcome|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008179|NCT00796120|E2|Reported Event|Doxorubicin Plus Ifosfamide|Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks along with ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
1008180|NCT00796120|E1|Reported Event|Trabectedin|Trabectedin 1.5 milligram per square meter (mg/m^2) given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
1008181|NCT00796003|B3|Baseline|Total|Total of all reporting groups
1008182|NCT00796003|B2|Baseline|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
1008183|NCT00796003|B1|Baseline|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008184|NCT00796003|P2|Participant Flow|Phase I and II: 20 mg/m2|Phase I: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1. Phase II: 20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) other cycles (except Cycle I)
1008185|NCT00796003|P1|Participant Flow|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008186|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008187|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008188|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008189|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008190|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008191|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008192|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008193|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008194|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008195|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008548|NCT00795132|O2|Outcome|Unrelated BM PBSC|Unrelated donor: bone marrow or peripheral blood stem cell (PBSC)
1008196|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008197|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008198|NCT00796003|O3|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008199|NCT00796003|O2|Outcome|Phase I: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008200|NCT00796003|O1|Outcome|Phase I: 15 mg/m2|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of a 4-Week (28-day) Cycle 1
1008201|NCT00796003|O1|Outcome|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008202|NCT00796003|E3|Reported Event|Phase II: 20 mg/m2|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) cycles
1008203|NCT00796003|E2|Reported Event|Phase I - 20 mg/m2 Group|20 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
1008204|NCT00796003|E1|Reported Event|Phase I - 15 mg/m2 Group|15 mg/m2 of JNJ-30979754 (decitabine) administered once daily by 1-hour intravenous infusion from Day 1 to 5 of 4-Week (28-day) Cycle 1
1008205|NCT00795951|B1|Baseline|Single Arm Study|All subjects were patched with TRUE Test panels 1.1, 2.1 and 3.1
1008206|NCT00795951|P1|Participant Flow|Diagnostic Performance: Nickel Sulfate|Number of subjects with reactions recorded at visit 3 or 4
1008207|NCT00795951|O1|Outcome|Itching|Number of subjects who presented with itching at patch removal
1008208|NCT00795951|O1|Outcome|Adhesion|Number of subjects who presented with poor adhesion at patch removal
1008209|NCT00795951|O1|Outcome|Irritation|Number of subjects who presented with irritation at patch removal
1008210|NCT00795951|O1|Outcome|Persistent Reactions|Number of subjects who presented with persistent reactions
1008211|NCT00795951|O1|Outcome|Late Reactions|Number of subjects who presented with late reactions
1008212|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008213|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008214|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008215|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008216|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008217|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008218|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008219|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008220|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008221|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008222|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008223|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008224|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008225|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008226|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008227|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008228|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008229|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008230|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008231|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008232|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008233|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008234|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008235|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008236|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008237|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008238|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008239|NCT00795951|O1|Outcome|Diagnostic Performance|Number of subjects with positive reactions recorded at visit 3 or visit 4
1008240|NCT00795951|O1|Outcome|Diagnostic Performance: Nickel Sulfate|Number of subjects with a positive reaction to nickel sulfate at visit 3 or visit 4
1008241|NCT00795951|E1|Reported Event|Safety|Adverse Events
1008242|NCT00795886|B1|Baseline|Rapamycin|This includes all study participants.
1008243|NCT00795886|P1|Participant Flow|Rapamycin|This includes all study participants.
1008244|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
1008245|NCT00795886|O1|Outcome|Rapamycin|This includes all study participants.
1020863|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1008248|NCT00795769|B1|Baseline|Ondansteron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
1008249|NCT00795769|P1|Participant Flow|Ondansetron Therapy|"Patients receive ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
1008250|NCT00795769|O1|Outcome|Ondansetron Therapy|"Patients receive 16mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
1008251|NCT00795769|E1|Reported Event|Ondansteron Therapy|"Patients receive 16 mg ondansetron IV once 30-60 minutes before undergoing autologous peripheral blood stem cell transplantation.~ondansetron: Given IV~survey administration: Correlative studies~management of therapy complications: Ondansetron IV"
1008252|NCT00795717|B3|Baseline|Total|Total of all reporting groups
1008253|NCT00795717|B2|Baseline|Placebo Then Lovaza|"Placebo or Corn oil pill, dietary counseling~Corn oil pill : 2 capsules given twice daily for 12 weeks"
1008254|NCT00795717|B1|Baseline|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
1008255|NCT00795717|P2|Participant Flow|Placebo Then Lovaza|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily vs. Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks"
1008256|NCT00795717|P1|Participant Flow|Lovaza Then Placebo|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks vs. placebo 2 capsules given twice daily."
1008257|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily"
1008258|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
1008259|NCT00795717|O2|Outcome|Placebo|"Placebo, dietary counseling~Placebo : 2 capsules given twice daily"
1008260|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
1008261|NCT00795717|O2|Outcome|Placebo|"Corn oil, dietary counseling~Corn oil : 2 capsules given twice daily"
1008262|NCT00795717|O1|Outcome|Lovaza|"Lovaza, dietary counseling~Lovaza : Lovaza at a dose of 4g per day with each 1g capsule containing approximately 465 mg of eicosapentaenoic acid (EPA) and 375 docosahexaenoic acid (DHA) for 12 weeks."
1008263|NCT00795717|E2|Reported Event|Placebo|Placebo, dietary counseling
1008264|NCT00795717|E1|Reported Event|Lovaza-Active|Lovaza, dietary counseling
1008265|NCT00795704|B3|Baseline|Total|Total of all reporting groups
1008266|NCT00795704|B2|Baseline|Mulberry Leaf Extract|500 mg #2 capsules three times daily
1008267|NCT00795704|B1|Baseline|Placebo|Control Group
1008268|NCT00795704|P2|Participant Flow|Mulberry Leaf Extract|500 mg #2 capsules three times daily
1008269|NCT00795704|P1|Participant Flow|Placebo|Control Group
1008270|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
1008271|NCT00795704|O1|Outcome|Placebo|Control Group
1008272|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
1008273|NCT00795704|O1|Outcome|Placebo|Control Group
1008274|NCT00795704|O2|Outcome|Mulberry Leaf Extract|500 mg #2 capsules three times daily
1008275|NCT00795704|O1|Outcome|Placebo|Control Group
1008276|NCT00795704|E2|Reported Event|Mulberry Leaf Extract|500 mg #2 capsules three times daily
1008277|NCT00795704|E1|Reported Event|Placebo|Control Group
1008278|NCT00795639|B3|Baseline|Total|Total of all reporting groups
1008279|NCT00795639|B2|Baseline|Placebo|Matching placebo tablet once a day
1008280|NCT00795639|B1|Baseline|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
1008281|NCT00795639|P2|Participant Flow|Placebo|Matching placebo tablet once a day
1008282|NCT00795639|P1|Participant Flow|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
1008283|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
1008284|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
1008285|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
1008286|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
1008287|NCT00795639|O2|Outcome|Placebo|Matching placebo tablet once a day
1008288|NCT00795639|O1|Outcome|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
1008289|NCT00795639|E2|Reported Event|Placebo|Matching placebo tablet once a day
1008290|NCT00795639|E1|Reported Event|Sitaxsentan|Sitaxsentan 100 milligrams (mg) tablet orally once a day
1008291|NCT00795600|B3|Baseline|Total|Total of all reporting groups
1008292|NCT00795600|B2|Baseline|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008293|NCT00795600|B1|Baseline|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008294|NCT00795600|P2|Participant Flow|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008295|NCT00795600|P1|Participant Flow|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008296|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1020864|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1008297|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008298|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008299|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008300|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008301|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008302|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008303|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008304|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008305|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008306|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008307|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008308|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008309|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008310|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008311|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008312|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008313|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008314|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008315|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008316|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008317|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008318|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008319|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008320|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008321|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008322|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008323|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008324|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008325|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008326|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008327|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008328|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008329|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008330|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1010134|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1008331|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008332|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008333|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008334|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008335|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008336|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008337|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008338|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008339|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008340|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008341|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008342|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008343|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008344|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008345|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008346|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008347|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008348|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008349|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008350|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008351|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008352|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008353|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008354|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008355|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008356|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008357|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008358|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008359|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008360|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008361|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008362|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008363|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008364|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1010135|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1008365|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008366|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008367|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008368|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008369|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008370|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008371|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008372|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008373|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008374|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008375|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008376|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008377|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008378|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008379|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008380|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008381|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008382|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008383|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008384|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008385|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008386|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008387|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008388|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008389|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008390|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008391|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008392|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008393|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008394|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008395|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008396|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008397|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008398|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1010136|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1008399|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008400|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008401|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008402|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008403|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008404|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008405|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008406|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008407|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008408|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008409|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008410|NCT00795600|O2|Outcome|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008411|NCT00795600|O1|Outcome|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008412|NCT00795600|E2|Reported Event|Insulin NPH|Insulin isophane (Neutral Protamine Hagedorn, NPH) injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008413|NCT00795600|E1|Reported Event|Insulin Detemir|Insulin detemir injected subcutaneously (s.c.) in the evening in combination with insulin aspart injected s.c. as mealtime insulin for 26 weeks
1008414|NCT00795535|B1|Baseline|Trauma Patients|Patients transported to the trauma center by helicopter
1008415|NCT00795535|P1|Participant Flow|Trauma Patients|Patients transported to the trauma center by helicopter
1008416|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
1008417|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
1008418|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
1008419|NCT00795535|O1|Outcome|Trauma Patients|Patients transported to the trauma center by helicopter
1008420|NCT00795535|E1|Reported Event|Trauma Patients|Patients transported to the trauma center by helicopter
1008421|NCT00795509|B1|Baseline|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
1008422|NCT00795509|P1|Participant Flow|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
1008423|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
1008424|NCT00795509|O1|Outcome|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
1008425|NCT00795509|E1|Reported Event|Tolterodine Tartrate.|Participants taking Tolterodine tartrate.
1008426|NCT00795366|B3|Baseline|Total|Total of all reporting groups
1008427|NCT00795366|B2|Baseline|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
1008428|NCT00795366|B1|Baseline|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
1008429|NCT00795366|P2|Participant Flow|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
1008430|NCT00795366|P1|Participant Flow|AVP, Arginine Vasopressin|Vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
1008431|NCT00795366|O2|Outcome|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
1008432|NCT00795366|O1|Outcome|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
1008433|NCT00795366|E2|Reported Event|Standard Catecholamine|Standard catecholamine: Titrated catecholamine of attending physicians preference to cerebral perfusion pressure greater than 60 mm Hg.
1008434|NCT00795366|E1|Reported Event|AVP, Arginine Vasopressin|Vasopressin, arginine vasopressin: Titrated to cerebral perfusion pressure greater than 60 mm Hg
1008435|NCT00795340|B3|Baseline|Total|Total of all reporting groups
1008436|NCT00795340|B2|Baseline|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
1008437|NCT00795340|B1|Baseline|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
1008438|NCT00795340|P2|Participant Flow|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
1008439|NCT00795340|P1|Participant Flow|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
1008549|NCT00795132|O1|Outcome|Related BM PBSC|Related donor: bone marrow or peripheral blood stem cell (PBSC)
1008440|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
1008441|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
1008442|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
1008443|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
1008444|NCT00795340|O2|Outcome|Placebo|"Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.~carboplatin: Given IV~paclitaxel: Given IV~placebo: Given orally"
1008445|NCT00795340|O1|Outcome|Cediranib|"Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.~carboplatin: Given IV~cediranib maleate: Given orally~paclitaxel: Given IV"
1008446|NCT00795340|E2|Reported Event|Placebo|Patients receive oral placebo once daily on days 1-21 and paclitaxel and carboplatin as in arm I.
1008447|NCT00795340|E1|Reported Event|Cediranib|Patients receive oral cediranib once daily on days 1-21 and paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1.
1008448|NCT00795288|B3|Baseline|Total|Total of all reporting groups
1008449|NCT00795288|B2|Baseline|Control|placebo: Control group
1008450|NCT00795288|B1|Baseline|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
1008451|NCT00795288|P2|Participant Flow|Simvastatin|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
1008452|NCT00795288|P1|Participant Flow|Placebo|All SAH patients admitted to our institution were screened for enrollment. The inclusion criteria are as follows: age > 18, SAH from a ruptured cerebral aneurysm enrolled within 48 hours of hemorrhage, modified Fisher grade 2, 3, or 4 on initial CT scan and planned surgical or endovascular aneurysm repair. Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
1008453|NCT00795288|O2|Outcome|Placebo|"Placebo~placebo: Control group"
1008454|NCT00795288|O1|Outcome|Simvastatin, 80 mg/Day|"Simvastatin, 80 mg/day for 21 days~Simvastatin, 80 mg/day for 21 days: Active treatment group"
1008455|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
1008456|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
1008457|NCT00795288|O2|Outcome|Control|placebo: Control group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
1008458|NCT00795288|O1|Outcome|Simvastatin|Simvastatin, 80 mg/day once daily for a total of 21 days following acute SAH: Active treatment group Patients were randomized to receive either 80 mg of simvastatin or placebo once a day for 21 days after their hemorrhage.
1008459|NCT00795288|E2|Reported Event|Control|placebo: Control group
1008460|NCT00795288|E1|Reported Event|Simvastatin|"Simvastatin, 80 mg/day~Simvastatin, 80 mg/day for 21 days: Active treatment group"
1008461|NCT00795210|B4|Baseline|Total|Total of all reporting groups
1008462|NCT00795210|B3|Baseline|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
1008463|NCT00795210|B2|Baseline|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
1008464|NCT00795210|B1|Baseline|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
1008465|NCT00795210|P3|Participant Flow|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
1008466|NCT00795210|P2|Participant Flow|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
1008467|NCT00795210|P1|Participant Flow|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
1008468|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
1008469|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
1008470|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
1008471|NCT00795210|O3|Outcome|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
1008472|NCT00795210|O2|Outcome|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
1008473|NCT00795210|O1|Outcome|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
1008474|NCT00795210|E3|Reported Event|Growth Hormone Releasing Hormone|Growth Hormone Releasing Hormone (Tesamorelin) 2mg daily, injected subcutaneously, x 2 weeks
1008475|NCT00795210|E2|Reported Event|GH 2mg Daily|Recombinant human growth hormone 2mg SC once daily
1008476|NCT00795210|E1|Reported Event|GH 6mcg/kg/d|Recombinant human growth hormone 6mcg/kg SC once daily
1008477|NCT00795184|B1|Baseline|Group 1|NBI-pCLE
1008478|NCT00795184|P2|Participant Flow|NBI First HDWLE Second and pCLE|
1008479|NCT00795184|P1|Participant Flow|HDWLE First NBI Second and pCLE|
1008480|NCT00795184|O6|Outcome|HDWLE+NBI|
1008481|NCT00795184|O5|Outcome|HDWLE+pCLE|
1008482|NCT00795184|O4|Outcome|HDWLE+NBI+pCLE|
1008483|NCT00795184|O3|Outcome|pCLE|
1008484|NCT00795184|O2|Outcome|NBI (Narrow Band Imaging)|
1008485|NCT00795184|O1|Outcome|HDWLE|
1008486|NCT00795184|E1|Reported Event|Group 1|NBI-pCLE or pCLE-NBI
1008487|NCT00795145|B3|Baseline|Total|Total of all reporting groups
1020865|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1008488|NCT00795145|B2|Baseline|Cohort 2: Placebo, Linezolid 600 mg and 1200 mg, Moxifloxacin|Subjects were randomly assigned to placebo first then moxifloxacin followed by linezolid 600 mg and 1200 mg linezolid last in Sequence 1; or linezolid 600 mg first then linezolid 1200 mg followed by placebo and moxifloxacin last in Sequence 2; or, linezolid 1200 mg first then moxifloxacin 400 mg followed by linezolid 600 mg and placebo last in Sequence 3; or, moxifloxacin 400 mg first then placebo followed by linezolid 1200 mg and 600 mg linezolid last in Sequence 4. There was a washout period of 48 hours between each dose.
1008489|NCT00795145|B1|Baseline|Cohort 1: Placebo, Linezolid 900 mg and 1200 mg|Subjects were randomly assigned to placebo followed by linezolid 900 mg then 1200 mg linezolid in Sequence 1; or, linezolid 900 mg then linezolid 1200 mg followed by placebo in Sequence 2; or, linezolid 900 mg then placebo followed by linezolid 1200 mg in Sequence 3. There was a washout period of 48 hours between doses.
1008490|NCT00795145|P7|Participant Flow|Cohort 2: Sequence 4|Subjects were randomly assigned to moxifloxacin 400 mg first, then placebo followed by linezolid 1200 mg and 600 mg linezolid after a washout period of 48 hours between doses in Sequence 4.
1008491|NCT00795145|P6|Participant Flow|Cohort 2: Sequence 3|Subjects were randomly assigned to linezolid 1200 mg first, then moxifloxacin 400 mg followed by linezolid 600 mg and placebo after a washout period of 48 hours between doses in Sequence 3.
1008492|NCT00795145|P5|Participant Flow|Cohort 2: Sequence 2|Subjects were randomly assigned to linezolid 600 mg first, then linezolid 1200 mg followed by placebo and moxifloxacin, after a washout period of 48 hours between doses in Sequence 2.
1008493|NCT00795145|P4|Participant Flow|Cohort 2: Sequence 1|Subjects were randomly assigned to placebo, then moxifloxacin, followed by linezolid 600 mg and 1200 mg, after a washout period of 48 hours between doses in Sequence 1.
1008494|NCT00795145|P3|Participant Flow|Cohort 1: Sequence 3|Subjects were randomly assigned to linezolid 900 mg first, then 1200 mg linezolid, followed by placebo after a washout period of 48 hours between doses in Sequence 3.
1008495|NCT00795145|P2|Participant Flow|Cohort 1: Sequence 2|Subjects were randomly assigned to linezolid 900 mg first, then placebo, followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 2.
1008496|NCT00795145|P1|Participant Flow|Cohort 1: Sequence 1|Subjects were randomly assigned to placebo first, then linezolid 900 milligrams (mg) followed by 1200 mg linezolid, after a washout period of 48 hours between doses in Sequence 1.
1008497|NCT00795145|O4|Outcome|Moxifloxacin 400 mg|
1008498|NCT00795145|O3|Outcome|Cohort 2: Placebo|
1008499|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
1008500|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
1008501|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
1008502|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
1008503|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
1008504|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
1008505|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
1008506|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
1008507|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
1008508|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|
1008509|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|
1008510|NCT00795145|O1|Outcome|Cohort 2: 900 mg Linezolid|
1008511|NCT00795145|O3|Outcome|Cohort 2: 1200 mg Linezolid|
1008512|NCT00795145|O2|Outcome|Cohort 2: 600 mg Linezolid|
1008513|NCT00795145|O1|Outcome|Cohort 2: Placebo|
1008514|NCT00795145|O2|Outcome|Cohort 2: Placebo|
1008515|NCT00795145|O1|Outcome|Cohort 2: Moxifloxacin|Oral administration, positive control, not blinded.
1008516|NCT00795145|O3|Outcome|Cohort 2: Placebo|0.9% Saline
1008517|NCT00795145|O2|Outcome|Cohort 2: 1200 mg Linezolid|Zyvox IV Injection
1008518|NCT00795145|O1|Outcome|Cohort 2: 600 mg Linezolid|Zyvox IV Injection
1008519|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
1008520|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
1008521|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
1008522|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
1008523|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
1008524|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
1008525|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
1008526|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
1008527|NCT00795145|O2|Outcome|Cohort 1: 1200 mg Linezolid|
1008528|NCT00795145|O1|Outcome|Cohort 1: 900 mg Linezolid|
1008529|NCT00795145|O3|Outcome|Cohort 1: 1200 mg Linezolid|600 mL Zyvox as a constant rate IV infusion of 60 minutes.
1008530|NCT00795145|O2|Outcome|Cohort 1: 900 mg Linezolid|450 mL Zyvox plus 150 mL saline as a constant rate IV infusion of 60 minutes.
1008531|NCT00795145|O1|Outcome|Cohort 1: Placebo|600 milliliters (mL) saline as a constant rate intravenous (IV) infusion of 60 minutes.
1008532|NCT00795145|E7|Reported Event|Cohort 2: 400 mg Moxifloxacin|
1008533|NCT00795145|E6|Reported Event|Cohort 2: 1200 mg Linezolid|
1008534|NCT00795145|E5|Reported Event|Cohort 2: 600 mg Linezolid|
1008535|NCT00795145|E4|Reported Event|Cohort 2: Placebo|
1008536|NCT00795145|E3|Reported Event|Cohort 1: 1200 mg Linezolid|
1008537|NCT00795145|E2|Reported Event|Cohort 1: 900 mg Linezolid|
1008538|NCT00795145|E1|Reported Event|Cohort 1: Placebo|
1008539|NCT00795132|B1|Baseline|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
1008540|NCT00795132|P1|Participant Flow|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
1008541|NCT00795132|O3|Outcome|Unrelated Cord Blood|All incidences of enrolled patients were analyzed.
1008542|NCT00795132|O2|Outcome|Unrelated BM PBSC|All incidences of enrolled patients were analyzed.
1008543|NCT00795132|O1|Outcome|Related BM PBSC|All incidences of enrolled patients were analyzed.
1008544|NCT00795132|O3|Outcome|Unrelated Cord Blood|All participants were analyzed.
1008545|NCT00795132|O2|Outcome|Unrelated BM PBSC|All participants were analyzed.
1008546|NCT00795132|O1|Outcome|Related BM PBSC|All participants were analyzed.
1008550|NCT00795132|E1|Reported Event|All Study Participants|This group contains data from all groups (Related Bone marrow Peripheral Blood Stem Cell (BM PBSC), Unrelated Peripheral Blood Stem Cell (PBSC), and Unrelated Cord blood.
1008551|NCT00795002|B3|Baseline|Total|Total of all reporting groups
1008552|NCT00795002|B2|Baseline|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
1008553|NCT00795002|B1|Baseline|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
1008554|NCT00795002|P2|Participant Flow|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
1008555|NCT00795002|P1|Participant Flow|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
1008556|NCT00795002|O2|Outcome|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
1008557|NCT00795002|O1|Outcome|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
1008558|NCT00795002|E2|Reported Event|Arm II|Patients receive alvocidib IV over 30 minutes followed by alvocidib IV over 4 hours on days 1-3. Patients also receive cytarabine and mitoxantrone hydrochloride as in arm I.
1008559|NCT00795002|E1|Reported Event|Arm I|Patients receive alvocidib IV over 1 hour on days 1-3, cytarabine IV continuously over 72 hours on days 6-8, and mitoxantrone hydrochloride IV over 60-120 minutes on day 9.
1008560|NCT00794963|B3|Baseline|Total|Total of all reporting groups
1008561|NCT00794963|B2|Baseline|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
1008562|NCT00794963|B1|Baseline|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
1008563|NCT00794963|P2|Participant Flow|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
1008564|NCT00794963|P1|Participant Flow|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
1008565|NCT00794963|O2|Outcome|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
1008566|NCT00794963|O1|Outcome|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
1008567|NCT00794963|E2|Reported Event|Usual Care|Follow the 8-month outcome of schizophrenia patients with metabolic syndrome treated in the community
1008568|NCT00794963|E1|Reported Event|Integrated Care|Provide on-site internal medicine evaluation, treatment and follow up of metabolic syndrome for patients in Clozapine Clinic
1008569|NCT00794924|B3|Baseline|Total|Total of all reporting groups
1008570|NCT00794924|B2|Baseline|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
1008571|NCT00794924|B1|Baseline|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
1008572|NCT00794924|P2|Participant Flow|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
1008573|NCT00794924|P1|Participant Flow|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
1008574|NCT00794924|O2|Outcome|Placebo|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received placebo sachets for 45 days.
1008575|NCT00794924|O1|Outcome|Probiotics|Acutely hospitalized elderly patients in a geriatric orthopedic rehabilitation department received commercially available probiotics (VSL#3) for 45 days.
1008576|NCT00794820|B1|Baseline|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
1008577|NCT00794820|P1|Participant Flow|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
1008578|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
1008579|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
1008580|NCT00794820|O1|Outcome|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
1008581|NCT00794820|E1|Reported Event|FCR-Multiple Dose Rituximab|Fludarabine phosphate 25 mg/m^2 intravenous (IV) daily for 3 days (days 2-4) + Cyclophosphamide 250 mg/m^2 IV daily for 3 days (days 2-4)+ Rituximab 375 mg/m^2 IV for dose 1 (given 1 day prior to chemotherapy) then 500 mg/m^2 on days 2-3
1008582|NCT00794677|B3|Baseline|Total|Total of all reporting groups
1008583|NCT00794677|B2|Baseline|Placebo|Placebo once daily received as the first or second intervention
1008584|NCT00794677|B1|Baseline|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008585|NCT00794677|P2|Participant Flow|Placebo|Placebo once daily received as the first or second intervention
1008586|NCT00794677|P1|Participant Flow|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008587|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008588|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008589|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008590|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008591|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008592|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008593|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008594|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008595|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008596|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008597|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008598|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008599|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008600|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008601|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008602|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008603|NCT00794677|O2|Outcome|Placebo|Placebo once daily received as the first or second intervention
1008604|NCT00794677|O1|Outcome|Ezetimibe|Ezetimibe (10 mg/day) once daily received as the first or second intervention
1008605|NCT00794664|B3|Baseline|Total|Total of all reporting groups
1008606|NCT00794664|B2|Baseline|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008607|NCT00794664|B1|Baseline|Placebo|Weekly subcutaneous injections for 26 weeks
1008608|NCT00794664|P2|Participant Flow|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008609|NCT00794664|P1|Participant Flow|Placebo|Weekly subcutaneous injections for 26 weeks
1008610|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008611|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008612|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008613|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008614|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008615|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008616|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008617|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008618|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008619|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008620|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008621|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008622|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008623|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008624|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008625|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008626|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008627|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008628|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008629|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008630|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008631|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008632|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008633|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008634|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008635|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008636|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008637|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008638|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008639|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008640|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008641|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008642|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008643|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008644|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008645|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008646|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008647|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008648|NCT00794664|O2|Outcome|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008649|NCT00794664|O1|Outcome|Placebo|Weekly subcutaneous injections for 26 weeks
1008650|NCT00794664|E2|Reported Event|Mipomersen|200 mg weekly subcutaneous injections for 26 weeks
1008651|NCT00794664|E1|Reported Event|Placebo|Weekly subcutaneous injections for 26 weeks
1008652|NCT00794560|B5|Baseline|Total|Total of all reporting groups
1008653|NCT00794560|B4|Baseline|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
1008654|NCT00794560|B3|Baseline|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008655|NCT00794560|B2|Baseline|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
1008656|NCT00794560|B1|Baseline|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008657|NCT00794560|P4|Participant Flow|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
1008658|NCT00794560|P3|Participant Flow|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008659|NCT00794560|P2|Participant Flow|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
1008660|NCT00794560|P1|Participant Flow|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008661|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
1008662|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008663|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
1008664|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008665|NCT00794560|O4|Outcome|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
1008666|NCT00794560|O3|Outcome|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008667|NCT00794560|O2|Outcome|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
1008668|NCT00794560|O1|Outcome|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008669|NCT00794560|E4|Reported Event|Daily Life Setting: Standard Care|Recruitment of patients in community pharmacies into control group (standard care in community pharmacy)
1008670|NCT00794560|E3|Reported Event|Daily Life Setting: Intervention|"Recruitment of patients in trained community pharmacies into the intervention group. Intervention is done by trained pharmacists.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008671|NCT00794560|E2|Reported Event|Clinical Setting: Standard Care|Recruitment of patients in the hospital into the randomized control group (standard care in community pharmacy)
1008672|NCT00794560|E1|Reported Event|Clinical Setting: Intervention|"Recruitment of patients in the hospital into the randomized intervention group. Intervention is done by a trained pharmacist/Doctor of Philosophy-student in the study center (a pharmacy) or at patient's bedside in the hospital.~patient education: Possible, individualized interventions:~Improvement of patient's knowledge about medication, therapy and drug application by providing detailed written information material~Providing a complete equipment package for self-injection (disinfection patches, patches, plasters, waste disposal box for used syringes)~Patient training: oral instructions for self-injection (and application, if required), exercising the injection technique on a phantom~First self-injection under control of a specially trained pharmacist"
1008673|NCT00794547|B1|Baseline|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
1008674|NCT00794547|P2|Participant Flow|Phase 2|"In the Phase II part of the study, we will find out the response of subjects' cancer has to the combination of a fixed dose of calcitriol (determined in the phase I study) with standard chemotherapy.~Calcitriol: In this portion of the study, all patients will get the same dose of calcitriol (determined from the Phase I study) along with the standard chemotherapy"
1008675|NCT00794547|P1|Participant Flow|Phase 1|"In the Phase I part of the study, we will test the safety of calcitriol along with standard chemotherapy. In addition, the goal is to see what effects (good and bad) it has on you and your type of Non-Small Cell Lung Cancer. This study is ongoing. In this portion of the study, we are testing increasing doses of calcitriol in combination with standard chemotherapy. If 2/3 patients at any dose level experience side effects that are limiting, we will call the dose level below that dose the maximum tolerated dose.~Calcitriol: Escalating dose of Calcitriol will be infused IV over 1 hour every 21 days."
1008676|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
1008677|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
1008678|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
1008679|NCT00794547|O1|Outcome|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
1008680|NCT00794547|E1|Reported Event|Calcitriol + Cisplatin + Docetaxel|Calcitriol, administered IV at 30, 45, 60, 80, or 100 mcg/m^2 (every 21 days), along with Cisplatin, 75 mg/m^2 (every three weeks), and Docetaxel, 75 mg/m^2 (every three weeks).
1008681|NCT00794508|B1|Baseline|Experimental Retroviral-mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
1008682|NCT00794508|P1|Participant Flow|Gamma-retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the gamma-retroviral vector, MND-ADA, carrying the human ADA gene."
1008683|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
1008684|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
1008685|NCT00794508|O1|Outcome|Gamma-retroviral Mediated ADA Gene Transfer|Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow
1008686|NCT00794508|E1|Reported Event|Retroviral-mediated ADA Gene Transfer|"Transfer of the human ADA gene to isolated CD34+ cells from the bone marrow.~ADA gene transfer: Autologous CD34+ cells transduced with the retroviral vector MND-ADA, carrying the human ADA gene."
1008687|NCT00794469|B1|Baseline|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
1008688|NCT00794469|P1|Participant Flow|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
1008689|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
1008690|NCT00794469|O1|Outcome|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
1008691|NCT00794469|E1|Reported Event|Water|obese children (body mass index >95th percentile for age and sex) that will drink 10cc/kg of cold water (4 degrees centigrade)
1008692|NCT00794365|B1|Baseline|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
1008693|NCT00794365|P1|Participant Flow|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
1008694|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
1008695|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
1008725|NCT00794170|P2|Participant Flow|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection.
1008696|NCT00794365|O1|Outcome|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
1008697|NCT00794365|E1|Reported Event|Varenicline|Varenicline tartrate 0.5 milligrams (mg) once daily on Days 1 to 3, 0.5 mg twice daily (BID) on Days 4 to 7, and then 1 mg BID for the remainder of the treatment period (11 weeks).
1008698|NCT00794313|B1|Baseline|All Study Participants|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks or Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week or Sugar Pill : sugar pill, capsule, three times a day, 2 weeks"
1008699|NCT00794313|P3|Participant Flow|Placebo, Then Amantadine, Then Amantadine + Topiramate|Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2)
1008700|NCT00794313|P2|Participant Flow|Amantadine + Topiramate, Then Placebo, Then Amantadine|Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks then 7 Days washout then Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2)
1008701|NCT00794313|P1|Participant Flow|Amantadine, Then Amantadine + Topiramate, Then Placebo|Amantadine: Amantadine 200 mg capsule two times a day (week 1); Amantadine 300 mg capsule three times a day (week 2) then 7 Days washout then Amantadine +Topiramate: Amantadine, 200 mg capsule, two times a day with Topiramate 25 mg capsule two times a day (week 1), then Amantadine 300 mg capsule three times a day with Topiramate 50 mg capsule two times a day (week 2) then 7 Days washout then Placebo: Sugar pill 2 capsule three times a day, 2 weeks
1008702|NCT00794313|O3|Outcome|Sugar Pill|Sugar Pill: sugar pill, capsule, three times a day, 2 weeks
1008703|NCT00794313|O2|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate: Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
1008704|NCT00794313|O1|Outcome|Amantadine|Amantadine 300 mg: Amantadine, 300 mg, capsule, three times a day, two weeks
1008705|NCT00794313|O3|Outcome|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
1008706|NCT00794313|O2|Outcome|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
1008707|NCT00794313|O1|Outcome|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
1008708|NCT00794313|E3|Reported Event|Sugar Pill|Sugar Pill : sugar pill, capsule, three times a day, 2 weeks
1008709|NCT00794313|E2|Reported Event|Amantadine Plus Topiramate|"Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks~Topiramate : Topiramate, 25 mg, capsule, two times a day, 1 week Sugar Pill, capsule, one time a day, 1 week Topiramate, 50 mg, capsule, three times a day, 1 week"
1008710|NCT00794313|E1|Reported Event|Amantadine|Amantadine 300 mg : Amantadine, 300 mg, capsule, three times a day, two weeks
1008711|NCT00794196|B3|Baseline|Total|Total of all reporting groups
1008712|NCT00794196|B2|Baseline|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
1008713|NCT00794196|B1|Baseline|Usual Care|The control group will be receiving usual medical and pharmaceutical care.
1008714|NCT00794196|P2|Participant Flow|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
1008715|NCT00794196|P1|Participant Flow|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
1008716|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
1008717|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
1008718|NCT00794196|O2|Outcome|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
1008719|NCT00794196|O1|Outcome|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
1008720|NCT00794196|E2|Reported Event|Intervention Group|"Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.~Pharmaceutical care program for antidepressant treatment: The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment."
1008721|NCT00794196|E1|Reported Event|Usual Care|The control group will be receiving usual medical and pharmaceutical care at primary care level. They could be referred to specialized care when necessary (general practitioner's criteria).
1008722|NCT00794170|B3|Baseline|Total|Total of all reporting groups
1008723|NCT00794170|B2|Baseline|Usual Care|control
1008724|NCT00794170|B1|Baseline|Telephone and Print Based Intervention|This was a tailored phone call followed up by print materials.
1008726|NCT00794170|P1|Participant Flow|Telephone and Print Based Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
1008727|NCT00794170|O2|Outcome|Usual Care|The control group receives usual care at each clinical site and interacts with study personnel only for data collection. Both groups receive birthday cards from the study team.
1008728|NCT00794170|O1|Outcome|Telephone and Print Intervention|The I-SIGHT intervention consists of twelve interactive voice recognition (IVR) phone calls over a nine-month period and accompanying printed materials that are mailed to participants following each call. The phone call messages and print materials are tailored to individuals' circumstances using data from the screening and baseline interviews. The objectives of the calls are to provide individually-tailored messages to encourage compliance with medication taking, appointment-keeping, and refills (based on self-report); to provide knowledge about glaucoma; and to counsel patients on how to address barriers to compliance. The intervention is based on theoretical constructs from Social Cognitive Theory and the Health Belief Model, and emphasizes self-efficacy, medication taking skills, outcome expectancies, facilitators and barriers to compliance, and social support. The treatment group receives the tailored telephone intervention and mailed, printed materials.
1008729|NCT00794170|E2|Reported Event|Usual Care|
1008730|NCT00794170|E1|Reported Event|Telephone and Print Based Intervention|
1008731|NCT00794157|B4|Baseline|Total|Total of all reporting groups
1008732|NCT00794157|B3|Baseline|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008733|NCT00794157|B2|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008734|NCT00794157|B1|Baseline|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008735|NCT00794157|P3|Participant Flow|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008736|NCT00794157|P2|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008737|NCT00794157|P1|Participant Flow|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008738|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008739|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008740|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008741|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008742|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008743|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008770|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008744|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008745|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008746|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008747|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008748|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008749|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008750|NCT00794157|O3|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008751|NCT00794157|O2|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008752|NCT00794157|O1|Outcome|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008753|NCT00794157|E3|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008754|NCT00794157|E2|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008755|NCT00794157|E1|Reported Event|Indacaterol 150 μg|Patients received indacaterol 150 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1008756|NCT00794144|B3|Baseline|Total|Total of all reporting groups
1008757|NCT00794144|B2|Baseline|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
1008758|NCT00794144|B1|Baseline|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
1008759|NCT00794144|P2|Participant Flow|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
1008760|NCT00794144|P1|Participant Flow|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
1008761|NCT00794144|O2|Outcome|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
1008762|NCT00794144|O1|Outcome|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
1008763|NCT00794144|E2|Reported Event|Olopatadine Hydrochloride Nasal Spray Vehicle|Olopatadine Hydrochloride Nasal Spray Vehicle
1008764|NCT00794144|E1|Reported Event|Olopatadine Hydrochloride Nasal Spray 0.6%|Olopatadine Hydrochloride Nasal Spray 0.6%
1008765|NCT00794118|B1|Baseline|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008766|NCT00794118|P1|Participant Flow|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008767|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008768|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008769|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008832|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1020866|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1008771|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008772|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008773|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008774|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008775|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008776|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008777|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008778|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008779|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008780|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008781|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008782|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008783|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008784|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008785|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008786|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008787|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008788|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008789|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008790|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008791|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008792|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008793|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008794|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008795|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008796|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008797|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008833|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1008834|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1008798|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008799|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008800|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008801|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008802|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008803|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008804|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008805|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008806|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008807|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008808|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008809|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008810|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008811|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008812|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008813|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008814|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008815|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008816|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008817|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008818|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008819|NCT00794118|O1|Outcome|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008820|NCT00794118|E1|Reported Event|Anti-tumor Necrosis Factor (Anti-TNF) Agents|Participants with rheumatoid arthritis (RA) prescribed with anti-TNF agents (etanercept, adalimumab, infliximab) as per investigator’s discretion were observed for a period of 12 months.
1008821|NCT00793910|B3|Baseline|Total|Total of all reporting groups
1008822|NCT00793910|B2|Baseline|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1008823|NCT00793910|B1|Baseline|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1008824|NCT00793910|P2|Participant Flow|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1008825|NCT00793910|P1|Participant Flow|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1008826|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1008827|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1008828|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1008829|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1008830|NCT00793910|O2|Outcome|Placebo|placebo (sugar pill) taken by mouth thrice daily for 7 days
1008831|NCT00793910|O1|Outcome|Gabapentin|Gabapentin 300mg taken by mouth thrice daily for 7 days
1008838|NCT00793871|B1|Baseline|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008839|NCT00793871|P1|Participant Flow|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 milligram (mg) orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008840|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008841|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008842|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008843|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008844|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008845|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008846|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008885|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1010696|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1008847|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008848|NCT00793871|O1|Outcome|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008849|NCT00793871|E1|Reported Event|Sutent (Sunitinib Malate)|The starting dose of sunitinib was 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (schedule 4/2). Participants experiencing dose-limiting toxicity attributed to study medication had dose interrupted or reduced depending on individual tolerability. If dose reductions were required, the dose of 37.5 mg was achieved by administration of 3 × 12.5 mg capsules, and the dose of 25 mg was achieved by administration of 2 × 12.5 mg capsules. There was no limit for number of cycles for this study, study treatment was permanently discontinued upon disease progression, occurrence of unacceptable toxicity, withdrawal of participant consent, or another withdrawal criterion was met.
1008850|NCT00793819|B3|Baseline|Total|Total of all reporting groups
1008851|NCT00793819|B2|Baseline|Placebo|1 placebo capsule daily
1008852|NCT00793819|B1|Baseline|Silodosin 8mg|Silodosin 8mg daily
1008853|NCT00793819|P2|Participant Flow|Placebo|1 placebo capsule daily
1008854|NCT00793819|P1|Participant Flow|Silodosin 8mg|Silodosin 8mg daily
1008855|NCT00793819|O2|Outcome|Placebo|1 placebo capsule daily
1008856|NCT00793819|O1|Outcome|Silodosin 8mg|Silodosin 8mg daily
1008857|NCT00793819|E2|Reported Event|Placebo|1 placebo capsule daily
1008858|NCT00793819|E1|Reported Event|Silodosin 8mg|Silodosin 8mg daily
1008859|NCT00793793|B13|Baseline|Total|Total of all reporting groups
1008860|NCT00793793|B12|Baseline|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008861|NCT00793793|B11|Baseline|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008862|NCT00793793|B10|Baseline|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008863|NCT00793793|B9|Baseline|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008864|NCT00793793|B8|Baseline|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008865|NCT00793793|B7|Baseline|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008866|NCT00793793|B6|Baseline|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008867|NCT00793793|B5|Baseline|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008868|NCT00793793|B4|Baseline|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008869|NCT00793793|B3|Baseline|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008870|NCT00793793|B2|Baseline|TN: 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008871|NCT00793793|B1|Baseline|Treatment Naive (TN): Placebo|TN patient to receive Placebo + PegIFN/RBV for 28 days
1008872|NCT00793793|P12|Participant Flow|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008873|NCT00793793|P11|Participant Flow|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008874|NCT00793793|P10|Participant Flow|TE Non-cirrhotic: 240 mg Twice a Day (BID) SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008875|NCT00793793|P9|Participant Flow|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008876|NCT00793793|P8|Participant Flow|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008877|NCT00793793|P7|Participant Flow|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008878|NCT00793793|P6|Participant Flow|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008879|NCT00793793|P5|Participant Flow|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008880|NCT00793793|P4|Participant Flow|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008881|NCT00793793|P3|Participant Flow|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008882|NCT00793793|P2|Participant Flow|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1008883|NCT00793793|P1|Participant Flow|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1008884|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008886|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008887|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008888|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008889|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008890|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008891|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008892|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008893|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008894|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1008895|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008896|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008897|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008898|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008899|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008900|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008901|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008902|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008903|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008904|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008905|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1008906|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008907|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008908|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008909|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008910|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008911|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008912|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008913|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008914|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008915|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008916|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008917|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008918|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008919|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008920|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008921|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008922|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008923|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008924|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008925|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008926|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008927|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008928|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008929|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008930|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008931|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008932|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008933|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008934|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008935|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008936|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008937|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008938|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008939|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008940|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008941|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008942|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008943|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008944|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008945|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008946|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008947|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008948|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008949|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008950|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008951|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008952|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008953|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008954|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008955|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008956|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008957|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008958|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008959|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008960|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008961|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008962|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008963|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008964|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008965|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008966|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008967|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008968|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008969|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008970|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008971|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008972|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008973|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008974|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008975|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008976|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008977|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008978|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008979|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008980|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008981|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008982|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008983|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008984|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008985|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008986|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008987|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008988|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008989|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008990|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008991|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008992|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008993|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1008994|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1008995|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008996|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008997|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008998|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1008999|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009000|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009001|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009002|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009003|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009004|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009005|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009006|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009007|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009008|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009009|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009010|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009011|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009012|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009013|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009014|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009015|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009016|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009017|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009018|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009019|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009020|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009021|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009022|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009023|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009024|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009025|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009026|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009027|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009028|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009029|NCT00793793|O10|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009030|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009031|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009032|NCT00793793|O7|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009033|NCT00793793|O6|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009034|NCT00793793|O5|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009035|NCT00793793|O4|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009036|NCT00793793|O3|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009037|NCT00793793|O2|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009038|NCT00793793|O1|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009039|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009040|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009041|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009042|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009043|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009044|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009045|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009046|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009047|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009048|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009049|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009050|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009051|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009052|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009053|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009054|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009055|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009056|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009057|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE patient non-cirrhotic to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009058|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009059|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009060|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009061|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009062|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009063|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009064|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009065|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009066|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009067|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009068|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009069|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009070|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1020867|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1009071|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009072|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009073|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1009074|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1009075|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009076|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009077|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009078|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009079|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009080|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009081|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009082|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009083|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009084|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009085|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1009086|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1009087|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009088|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009089|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009090|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009091|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009092|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009093|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009094|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009095|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009096|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009097|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1009098|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1009099|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009100|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009101|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009102|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009103|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009104|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009105|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009106|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009107|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009108|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009109|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009110|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009111|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009112|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009113|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009114|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009115|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1020868|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1009116|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009117|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009118|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009119|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009120|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009121|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009122|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009123|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009124|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009125|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009126|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009127|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009128|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009129|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009130|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009131|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009132|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009133|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1009134|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1009135|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009136|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009137|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009138|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009139|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009140|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009141|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009142|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009143|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009144|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009145|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1009146|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1009147|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009148|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009149|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009150|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009151|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009152|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009153|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009154|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009155|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009156|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009157|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009158|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009159|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009160|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009161|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009162|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009163|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009164|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009165|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009166|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009167|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009168|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009169|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009170|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009171|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009172|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009173|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009174|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009175|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009176|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009177|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009178|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009179|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009180|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009181|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg Per Day (QD)|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1009182|NCT00793793|O1|Outcome|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1009183|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009184|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009185|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009186|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009187|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009188|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009189|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009190|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009191|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009192|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009193|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009194|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009195|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009196|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009197|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009198|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009199|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009200|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009201|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009202|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009203|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009204|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009205|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009206|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009207|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1011002|NCT00790023|O1|Outcome|80 mcg Ciclesonide|80 mcg Ciclesonide once daily
1009208|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009209|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009210|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009211|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009212|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009213|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009214|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009215|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009216|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009217|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009218|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009219|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009220|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009221|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009222|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009223|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009224|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009225|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48 mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009226|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009227|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009228|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009229|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009230|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009231|NCT00793793|O12|Outcome|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009232|NCT00793793|O11|Outcome|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009233|NCT00793793|O10|Outcome|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009234|NCT00793793|O9|Outcome|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009235|NCT00793793|O8|Outcome|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009236|NCT00793793|O7|Outcome|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009237|NCT00793793|O6|Outcome|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009238|NCT00793793|O5|Outcome|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009239|NCT00793793|O4|Outcome|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009240|NCT00793793|O3|Outcome|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009241|NCT00793793|O2|Outcome|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009242|NCT00793793|O1|Outcome|TN: Placebo|TN patient to receive Placebo +/- PegIFN/RBV for 28 days
1009243|NCT00793793|E12|Reported Event|TE With Cirrhosis: 240 mg BID SGC|TE with cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009244|NCT00793793|E11|Reported Event|TE With Cirrhosis: 240 mg QD SGC|TE with cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009245|NCT00793793|E10|Reported Event|TE Non-cirrhotic: 240 mg BID SGC|TE non-cirrhotic patient to receive 240mg BID SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009246|NCT00793793|E9|Reported Event|TE Non-cirrhotic: 240 mg QD Soft Gel Capsule (SGC)|TE non-cirrhotic patient to receive 240mg QD SGC solution BI201335 qd +/- PegIFN/RBV for 28 days
1009247|NCT00793793|E8|Reported Event|TE Non-cirrhotic: 240 mg QD|TE non-cirrhotic patient to receive 240mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009248|NCT00793793|E7|Reported Event|TE Non-cirrhotic: 120 mg QD|TE non-cirrhotic patient to receive 120mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009249|NCT00793793|E6|Reported Event|Treatment Experienced (TE) Non-cirrhotic: 48 mg QD|TE non-cirrhotic patient to receive 48mg QD solution BI201335 qd +/- PegIFN/RBV for 28 days
1009250|NCT00793793|E5|Reported Event|TN: 240mg QD|TN patient to receive 240mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009251|NCT00793793|E4|Reported Event|TN: 120mg QD|TN patient to receive 120mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009252|NCT00793793|E3|Reported Event|TN: 48mg QD|TN patient to receive 48mg solution BI201335 qd +/- PegIFN/RBV for 28 days
1009253|NCT00793793|E2|Reported Event|Treatment Naive(TN): 20mg QD|TN patient to receive 20mg QD solution Faldaprevir (BI201335) qd +/- PegIFN/RBV for 28 days
1011003|NCT00790023|O3|Outcome|Placebo|Placebo once daily
1009254|NCT00793793|E1|Reported Event|Treatment Naive (TN): Placebo|TN patient to receive Placebo +/- Pegylated interferon alpha-2a solution for injection/Ribavirin tablet (PegIFN/RBV) for 28 days
1009255|NCT00793780|B3|Baseline|Total|Total of all reporting groups
1009256|NCT00793780|B2|Baseline|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009257|NCT00793780|B1|Baseline|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009258|NCT00793780|P2|Participant Flow|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009259|NCT00793780|P1|Participant Flow|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009260|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009261|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009262|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009263|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009264|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009265|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009266|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009267|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009268|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009269|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009270|NCT00793780|O2|Outcome|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009271|NCT00793780|O1|Outcome|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009272|NCT00793780|E2|Reported Event|Placebo|Placebo: Placebo caplet (inactive substance) taken orally once a day for 8 weeks
1009273|NCT00793780|E1|Reported Event|Naltrexone 25mg|Naltrexone 25mg: Naltrexone 25mg caplets taken orally once a day for 8 weeks
1009274|NCT00793650|B3|Baseline|Total|Total of all reporting groups
1009275|NCT00793650|B2|Baseline|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009276|NCT00793650|B1|Baseline|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009277|NCT00793650|P2|Participant Flow|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009278|NCT00793650|P1|Participant Flow|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009279|NCT00793650|O2|Outcome|Bortezomib After Melphalan|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009280|NCT00793650|O1|Outcome|Bortezomib Before Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009281|NCT00793650|O2|Outcome|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009282|NCT00793650|O1|Outcome|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009283|NCT00793650|E2|Reported Event|Bortezomib After HD melphalanAll|"patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours after administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009284|NCT00793650|E1|Reported Event|Bortezomib Before HD Melphalan|"All patients received melphalan (100 mg/m^2/day × 2; days~−3 and −2), for a total dose of 200 mg/m^2. Patients were randomized to receive bortezomib 24 hours before administration of high-dose melphalan in escalating dose cohorts of 1.0, 1.3, and 1.6 mg/m^2"
1009285|NCT00793624|B5|Baseline|Total|Total of all reporting groups
1009286|NCT00793624|B4|Baseline|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009287|NCT00793624|B3|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009288|NCT00793624|B2|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009289|NCT00793624|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009290|NCT00793624|P4|Participant Flow|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009291|NCT00793624|P3|Participant Flow|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009292|NCT00793624|P2|Participant Flow|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009293|NCT00793624|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009294|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009295|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009296|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009297|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009298|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009299|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009300|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009301|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009302|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009303|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009304|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009305|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009306|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009307|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009308|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009309|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009310|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009311|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009312|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009313|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009314|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009315|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009316|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009317|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009318|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
1009319|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
1009320|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1009321|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1009322|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1009323|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1009324|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1009325|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1009326|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
1009327|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
1009328|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1009329|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1009330|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1009331|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1009332|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1009333|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1009334|NCT00793624|O8|Outcome|Form 12 mcg (Non-tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - non-tiotropium stratum
1009335|NCT00793624|O7|Outcome|Form 12 mcg (Tiotropium)|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler - tiotropium stratum
1009336|NCT00793624|O6|Outcome|Olo 10 mcg qd(Non-tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1009337|NCT00793624|O5|Outcome|Olo 10 mcg qd (Tiotropium)|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1009338|NCT00793624|O4|Outcome|Olo 5 mcg qd (Non-tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - non-tiotropium stratum
1009339|NCT00793624|O3|Outcome|Olo 5 mcg qd (Tiotropium)|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler - tiotropium stratum
1009340|NCT00793624|O2|Outcome|Placebo (Non-tiotropium)|Matching Placebo delivered by the Respimat Inhaler - non-tiotropium use stratum.
1009341|NCT00793624|O1|Outcome|Placebo (Tiotropium)|Matching Placebo delivered by the Respimat Inhaler - tiotropium use stratum
1009342|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009343|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009344|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009345|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009346|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009347|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009348|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009349|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009350|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009351|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009352|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009353|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009354|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009355|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009356|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009357|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009358|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009359|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009360|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009361|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009362|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009363|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009364|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009365|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009366|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009367|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009368|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009369|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009370|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009371|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009372|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009373|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009374|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009375|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009376|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009377|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009378|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009379|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009380|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009381|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009382|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009383|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009384|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009385|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009386|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009387|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009388|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009389|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009390|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009391|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009392|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009393|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009394|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009395|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009396|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009397|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009398|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009399|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009400|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009401|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009402|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009403|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009404|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009405|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009406|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009407|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009408|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009409|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009410|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009411|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009412|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009413|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009414|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009415|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009416|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009417|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009418|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009419|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009420|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009421|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009422|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009423|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009424|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009425|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009426|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009427|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009428|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009429|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009430|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009431|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009432|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009433|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009434|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009435|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009436|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009437|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009438|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009439|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009440|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009441|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009442|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009443|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009444|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009445|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009446|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009447|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009448|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009449|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009450|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009451|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009452|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009453|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009454|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009455|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009456|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009457|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009458|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009459|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009460|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009461|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009462|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009463|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009464|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009465|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009466|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009467|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009468|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009469|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009470|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009471|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009472|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009473|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009474|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009475|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009476|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009477|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009478|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009479|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009480|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009481|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009482|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009483|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009484|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009485|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009486|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009487|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009488|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009489|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009490|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009491|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009492|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009493|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009494|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009495|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009496|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009497|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009498|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009499|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009500|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009501|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009502|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009503|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009504|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009505|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009506|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009507|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009508|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009509|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009510|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009511|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009512|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009513|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009514|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009515|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009516|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009517|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009518|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009519|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009520|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009521|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009522|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009523|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009524|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009525|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009526|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009527|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009528|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009529|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009530|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009531|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009532|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009533|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009534|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009535|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009536|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009537|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009538|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009539|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009540|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009541|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009542|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009543|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009544|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009545|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009546|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009547|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009548|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009549|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009550|NCT00793624|O4|Outcome|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009551|NCT00793624|O3|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009552|NCT00793624|O2|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009553|NCT00793624|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009554|NCT00793624|E4|Reported Event|Form 12 mcg|Foradil 12 mcg bid (morning and evening) delivered by the Aerolizer Inhaler.
1009555|NCT00793624|E3|Reported Event|Olodaterol (Olo) 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
1009556|NCT00793624|E2|Reported Event|Olodaterol (Olo) 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
1009557|NCT00793624|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
1009558|NCT00793611|B3|Baseline|Total|Total of all reporting groups
1009559|NCT00793611|B2|Baseline|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
1009560|NCT00793611|B1|Baseline|Behavioral Therapy Standard Care|received 3 behavioral therapy session
1009561|NCT00793611|P2|Participant Flow|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
1009562|NCT00793611|P1|Participant Flow|Behavioral Therapy Standard Care|received 3 behavioral therapy session
1009563|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
1009564|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
1009565|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
1009566|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
1009567|NCT00793611|O2|Outcome|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
1009568|NCT00793611|O1|Outcome|Behavioral Therapy Standard Care|received 3 behavioral therapy session
1009569|NCT00793611|E2|Reported Event|Hypnotherapy|received 3 sessions of behavioral therapy combined with hypnotherapy
1009570|NCT00793611|E1|Reported Event|Behavioral Therapy Standard Care|received 3 behavioral therapy session
1009571|NCT00793585|B3|Baseline|Total|Total of all reporting groups
1009572|NCT00793585|B2|Baseline|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
1009573|NCT00793585|B1|Baseline|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
1009574|NCT00793585|P2|Participant Flow|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
1009575|NCT00793585|P1|Participant Flow|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
1009615|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009576|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
1009577|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
1009578|NCT00793585|O2|Outcome|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
1009579|NCT00793585|O1|Outcome|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
1009580|NCT00793585|E2|Reported Event|Allopurinol Group|Patients in the treatment group received allopurinol, 100-300mg/d according to the levels of Scr and UA. For those with Scr<1.5mg/dl (133µmol/L) at the baseline, allopurinol was given 100mg three times daily, and changed to 100mg twice daily when serum uric acid deceased to the normal range. For patients with Scr>=1.5mg/dl at baseline, allopurinol was initiated at 100mg twice daily and was decreased to 100mg daily when uric acid decreased into the normal range.
1009581|NCT00793585|E1|Reported Event|Control Group|Control group:(patient in this group were received health education and were encouraged to adhere to a low-purine diet.Patients diagnosed with hypertension received antihypertensive drugs with titration of CCB and β-blocker during the follow-up.The target of BP is less than 130/80mmHg.
1009582|NCT00793572|B1|Baseline|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009583|NCT00793572|P1|Participant Flow|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009584|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009585|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009586|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009587|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009588|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009616|NCT00793546|O2|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009897|NCT00791999|P2|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
1009589|NCT00793572|O1|Outcome|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009590|NCT00793572|E1|Reported Event|Tandem Auto-/Nonmyeloablative Allo-HCT and Maintenance Therapy|"See Detailed Description~Autologous Hematopoietic Stem Cell Transplantation: Undergo transplantation~Bortezomib: Given SC~Cyclosporine: Given IV~Cyclosporine: Given PO~Fludarabine Phosphate: Given IV~Laboratory Biomarker Analysis: Correlative studies~Melphalan: Given IV~Mycophenolate Mofetil: Given PO~Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation: Undergo transplantation~Peripheral Blood Stem Cell Transplantation: Undergo transplantation~Syngeneic Bone Marrow Transplantation: Undergo transplantation~Total-Body Irradiation: Undergo radiotherapy"
1009591|NCT00793546|B3|Baseline|Total|Total of all reporting groups
1009592|NCT00793546|B2|Baseline|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009593|NCT00793546|B1|Baseline|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009594|NCT00793546|P2|Participant Flow|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009595|NCT00793546|P1|Participant Flow|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009596|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009597|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009598|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009599|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009600|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009601|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009602|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009603|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009604|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009605|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009606|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009607|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009608|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009609|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009610|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009611|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009612|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009613|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009614|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1020869|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1009617|NCT00793546|O1|Outcome|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009618|NCT00793546|O2|Outcome|Exemestane 25 mg (Part 2)|Exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptible toxicity or withdrawal of consent.
1009619|NCT00793546|O1|Outcome|Bosutinib 300 mg + Exemestane 25 mg (Part 2)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009620|NCT00793546|E2|Reported Event|Bosutinib 300 mg + Exemestane 25 mg (Part 1)|Three bosutinib 100 mg tablets (equivalent to 300 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009621|NCT00793546|E1|Reported Event|Bosutinib 400 mg + Exemestane 25 mg (Part 1)|Four bosutinib 100 milligram (mg) tablets (equivalent to 400 mg bosutinib) orally along with exemestane 25 mg tablet orally once daily up to 6 months or until disease progression, unacceptable toxicity, withdrawal of consent.
1009622|NCT00793520|B3|Baseline|Total|Total of all reporting groups
1009623|NCT00793520|B2|Baseline|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
1009624|NCT00793520|B1|Baseline|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
1009625|NCT00793520|P2|Participant Flow|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
1009626|NCT00793520|P1|Participant Flow|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
1009627|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
1009628|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
1009629|NCT00793520|O2|Outcome|Placebo to Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
1009630|NCT00793520|O1|Outcome|Milnacipran to Placebo|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
1009631|NCT00793520|E2|Reported Event|Placebo|Twice daily oral administration of placebo for 5 weeks, placebo for 2 weeks, and crossover to milnacipran for 5 weeks.
1009632|NCT00793520|E1|Reported Event|Milnacipran|Twice daily oral administration of milnacipran for 5 weeks, placebo for 2 weeks, and crossover to placebo for 5 weeks.
1009633|NCT00793455|B3|Baseline|Total|Total of all reporting groups
1009634|NCT00793455|B2|Baseline|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
1009635|NCT00793455|B1|Baseline|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
1009636|NCT00793455|P2|Participant Flow|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
1009637|NCT00793455|P1|Participant Flow|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
1009638|NCT00793455|O2|Outcome|Intervention Group|Received outreach intervention
1009639|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
1009640|NCT00793455|O2|Outcome|Intervention Group|Received Educational Outreach
1009641|NCT00793455|O1|Outcome|Usual Care Control Group|Usual Care
1009642|NCT00793455|E2|Reported Event|Usual Care Control Group|Participants in this arm will receive normal care until outcome assessment is performed at 6 months following the placement of the order for the preventive service. They will be sent a letter reminding them to obtain the ordered preventive service test.
1009643|NCT00793455|E1|Reported Event|Intervention Group|Participants assigned to this group received a one-time educational intervention within one week of randomization. Educational intervention consisted of a letter from patient's physician, a brochure about colorectal cancer screening, and a DVD about colorectal cancer screening.
1009644|NCT00793403|B1|Baseline|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009645|NCT00793403|P1|Participant Flow|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009646|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009647|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009814|NCT00792636|O1|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009815|NCT00792636|E3|Reported Event|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009648|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009649|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009650|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009651|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009652|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009653|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009654|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009655|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009656|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009657|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009658|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009659|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009660|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009661|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009662|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009663|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009664|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009665|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009666|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009667|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009816|NCT00792636|E2|Reported Event|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1020870|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1009668|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009669|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009670|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009671|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009672|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009673|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009674|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009675|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009676|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009677|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009678|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009679|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009680|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009681|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009682|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009683|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009684|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009685|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009686|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009687|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009817|NCT00792636|E1|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009688|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009689|NCT00793403|O1|Outcome|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009690|NCT00793403|E1|Reported Event|All Participants|Active Rheumatoid Arthritis (RA) participants who were partial or non-responders to the previous Disease Modifying Anti Rheumatic Drugs (DMARDs) treatment were prescribed with anti-Tumor Necrosis Factor (TNF) therapy (infliximab, etanercept, and adalimumab) as per usual clinical practice and observed for 12 months.
1009691|NCT00793325|B1|Baseline|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
1009692|NCT00793325|P1|Participant Flow|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
1009693|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the height SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
1009694|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants whose change in the growth rate SD scores was measured at one, two, and three years of taking somatropin for small-for-gestational age according to Japanese package insert.
1009695|NCT00793325|O2|Outcome|Participants Without Concomitant Drug(s)|Participants taking no concomitant drugs while taking somatropin for SGA according to Japanese package insert.
1009696|NCT00793325|O1|Outcome|Participants With Concomitant Drug(s)|Participants taking concomitant drug(s) while taking somatropin for SGA according to Japanese package insert.
1009697|NCT00793325|O2|Outcome|Participants Without Renal Impairment|Participants without renal impairment taking somatropin for SGA according to Japanese package insert.
1009698|NCT00793325|O1|Outcome|Participants With Renal Impairment|Participants with renal impairment taking somatropin for SGA according to Japanese package insert.
1009699|NCT00793325|O2|Outcome|Participants Without Hepatic Function Disorder|Participants without hepatic function disorder taking somatropin for SGA according to Japanese package insert.
1009700|NCT00793325|O1|Outcome|Participants With Hepatic Function Disorder|Participants with hepatic function disorder taking somatropin for SGA according to Japanese package insert.
1009701|NCT00793325|O2|Outcome|Participants Without Complication(s)|Participants without complications while taking somatropin for SGA according to Japanese package insert.
1009702|NCT00793325|O1|Outcome|Participants With Complication(s)|Participants with complication(s) while taking somatropin for SGA according to Japanese package insert.
1009703|NCT00793325|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for SGA according to Japanese package insert.
1009704|NCT00793325|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for SGA according to Japanese package insert.
1009705|NCT00793325|O3|Outcome|Severe SGA|Participants with severe SGA taking somatropin for SGA according to Japanese package insert.
1009706|NCT00793325|O2|Outcome|Moderate SGA|Participants with moderate SGA taking somatropin for SGA according to Japanese package insert.
1009707|NCT00793325|O1|Outcome|Mild SGA|Participants with mild SGA taking somatropin for SGA according to Japanese package insert.
1009708|NCT00793325|O2|Outcome|Female|Female Participants taking somatropin for SGA according to Japanese package insert.
1009709|NCT00793325|O1|Outcome|Male|Male Participants taking somatropin for SGA according to Japanese package insert.
1009710|NCT00793325|O2|Outcome|>=15 Years|Participants 15 years of age or older when taking somatropin for SGA according to Japanese package insert.
1009711|NCT00793325|O1|Outcome|<15 Years|Participants younger than 15 years of age when taking somatropin for SGA according to Japanese package insert.
1009712|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
1009713|NCT00793325|O1|Outcome|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
1009714|NCT00793325|E1|Reported Event|Somatropin for Small-for-gestational Age|Participants taking somatropin for small-for-gestational age according to Japanese package insert.
1009715|NCT00793169|B1|Baseline|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
1009716|NCT00793169|P1|Participant Flow|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
1009717|NCT00793169|O1|Outcome|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
1009718|NCT00793169|E1|Reported Event|Detectable Lidocaine Concentrations at Each Blood Draw|The number of subjects with detectable serum lidocaine concentrations (<0.1 ug/mL) at each blood draw.
1009719|NCT00793104|B1|Baseline|CR Plug|Placement of allograft CR Plug in primary injury site
1009720|NCT00793104|P1|Participant Flow|CR Plug|Placement of allograft CR Plug in primary injury site
1009721|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
1009722|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
1009723|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
1009724|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
1009725|NCT00793104|O1|Outcome|CR Plug|Placement of allograft CR Plug in primary injury site
1009726|NCT00793104|E1|Reported Event|CR Plug|Placement of allograft CR Plug in primary injury site
1009727|NCT00792948|B1|Baseline|Treatment|
1009848|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009728|NCT00792948|P1|Participant Flow|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
1009729|NCT00792948|O1|Outcome|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
1009730|NCT00792948|O1|Outcome|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
1009731|NCT00792948|O1|Outcome|Treatment|"See Detailed Description~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Cyclophosphamide: Given IV~Cytarabine: Given IT~Dasatinib: Given PO~Dexamethasone: Given IV or PO~Doxorubicin Hydrochloride: Given IV~Etoposide: Given IV~Filgrastim: Given SC~Laboratory Biomarker Analysis: Correlative studies~Leucovorin Calcium: Given IV~Methotrexate: Given IV or IT~Methylprednisolone: Given IV~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic stem cell transplant~Prednisone: Given PO~Sirolimus: Given PO~Tacrolimus: Given IV~Total-Body Irradiation: Undergo TBI~Vincristine Sulfate: Given IV"
1009732|NCT00792948|E4|Reported Event|Dasatinib|Patients receive Single-Agent Dasatinib therapy PO every day for up to five years from original registration.
1009733|NCT00792948|E3|Reported Event|Allogeneic Stem Cell Transplant|Patients who have an available sibling donor or a 10/10 matched unrelated donor will be removed from therapy and proceed directly to allogeneic stem cell transplant after achieving CR or CRi.
1009734|NCT00792948|E2|Reported Event|Vincristine/Prednisone/Dasatinib|Patients receive vincristine IV on day 1, prednisone PO on days 1 to 5, and dasatinib PO on days 1 to 28 for up to 24 courses or until transplant is available.
1009735|NCT00792948|E1|Reported Event|Induction/Consolidation|Patients receive up to 8 courses, alternating between hyper-CVAD plus dasatinib and high dose methotrexate and cytarabine plus dasatinib. There are nine possible induction/consolidation courses.
1009736|NCT00792935|B3|Baseline|Total|Total of all reporting groups
1009737|NCT00792935|B2|Baseline|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009738|NCT00792935|B1|Baseline|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009739|NCT00792935|P2|Participant Flow|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009740|NCT00792935|P1|Participant Flow|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009741|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009742|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009743|NCT00792935|O2|Outcome|Glimepiride|Participants receive glimepiride 1 mg or 2 mg tablets, orally, QD and placebo tablets matching MK-0941 5 mg or 10 mg, orally, TID for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009744|NCT00792935|O1|Outcome|MK-0941|Participants receive MK-0941 5 mg or 10 mg tablets, orally, TID and placebo tablets matching glimepiride 1 mg or 2 mg, orally, QD for 6 weeks. Up-titration and down-titration of the dose could occur to achieve optimal individual glucose control. In addition, all participants received a maximum tolerated dose of metformin [(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)], after a 4-week dose titration/dose stabilization period.
1009745|NCT00792935|E2|Reported Event|Glimepiride|All patients as treated (APaT) defined as all randomized participants who received at least one dose of glimepiride.
1009746|NCT00792935|E1|Reported Event|MK-0941|All patients as treated (APaT) defined as all randomized participants who received at least one dose of MK-0941.
1009747|NCT00792805|B4|Baseline|Total|Total of all reporting groups
1009748|NCT00792805|B3|Baseline|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009749|NCT00792805|B2|Baseline|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009750|NCT00792805|B1|Baseline|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009751|NCT00792805|P3|Participant Flow|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009752|NCT00792805|P2|Participant Flow|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009753|NCT00792805|P1|Participant Flow|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009754|NCT00792805|O3|Outcome|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009755|NCT00792805|O2|Outcome|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009756|NCT00792805|O1|Outcome|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009757|NCT00792805|E3|Reported Event|Placebo to Indacaterol|Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009758|NCT00792805|E2|Reported Event|Indacaterol 300 μg|Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009759|NCT00792805|E1|Reported Event|Indacaterol 150 μg|Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
1009760|NCT00792688|B4|Baseline|Total|Total of all reporting groups
1009761|NCT00792688|B3|Baseline|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009762|NCT00792688|B2|Baseline|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009763|NCT00792688|B1|Baseline|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009764|NCT00792688|P3|Participant Flow|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009849|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009765|NCT00792688|P2|Participant Flow|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009766|NCT00792688|P1|Participant Flow|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009767|NCT00792688|O3|Outcome|All Treatments Placebo|
1009768|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
1009769|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
1009770|NCT00792688|O3|Outcome|All Treatments Placebo|
1009771|NCT00792688|O2|Outcome|All Treatments GLYC-101 Gel, 1.0%|
1009772|NCT00792688|O1|Outcome|All Treatments GLYC-101 Gel, 0.1%|
1009773|NCT00792688|E3|Reported Event|GLYC-101 Gel 0.1% on 1 Eyelid & GLYC-101 Gel 1.0% on the Other|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009774|NCT00792688|E2|Reported Event|GLYC-101 Gel, 1.0% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009775|NCT00792688|E1|Reported Event|GLYC-101 Gel, 0.1% on One Eyelid & Placebo on the Other Eyelid|"GLYC-101 Gel (0.1%) Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5.~Placebo Gel Topical administration to the laser-ablated area on Days 1 (day of laser ablation), 2, 3, 4, and 5."
1009776|NCT00792636|B4|Baseline|Total|Total of all reporting groups
1009777|NCT00792636|B3|Baseline|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009778|NCT00792636|B2|Baseline|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009779|NCT00792636|B1|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009780|NCT00792636|P3|Participant Flow|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009781|NCT00792636|P2|Participant Flow|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009782|NCT00792636|P1|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009783|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009784|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009785|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009786|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009787|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009788|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009789|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009790|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009791|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009792|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009793|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009794|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009795|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009796|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009797|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009798|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009799|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009800|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009801|NCT00792636|O3|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009802|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009803|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009804|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009805|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009806|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009807|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009808|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009809|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009810|NCT00792636|O2|Outcome|Sumatriptan|Sumatriptan 85 mg tablet taken after migraine attack
1009811|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009812|NCT00792636|O1|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 milligrams (mg) and naproxen sodium 500 mg combination tablet taken after migraine attack
1009813|NCT00792636|O2|Outcome|Naproxen|Naproxen sodium 500 mg tablet taken after migraine attack
1009818|NCT00792610|B1|Baseline|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
1009819|NCT00792610|P1|Participant Flow|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
1009820|NCT00792610|O1|Outcome|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
1009821|NCT00792610|E1|Reported Event|Hepatitis B Booster|They receive 3 doses of hepatitis B vaccine (Engerix-B Injection, recombinant HBsAg, 20mcg/ml/vial, GSK) at 0, 1st, 6th month during follow-up. Their anti-HBs status were checked at baseline, one week, one month, sixth month, and seven months later after the first dose of hepatitis B vaccine.
1009822|NCT00792298|B1|Baseline|All Treated Participants|All randomized participants who received at least one dose of study treatment.
1009823|NCT00792298|P8|Participant Flow|Placebo → Suvorexant 80 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 80 mg suvorexant daily prior to bedtime during Treatment Period 2.
1009824|NCT00792298|P7|Participant Flow|Suvorexant 80 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 80 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
1009825|NCT00792298|P6|Participant Flow|Placebo → Suvorexant 40 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 40 mg suvorexant daily prior to bedtime during Treatment Period 2.
1009826|NCT00792298|P5|Participant Flow|Suvorexant 40 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 40 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
1009827|NCT00792298|P4|Participant Flow|Placebo → Suvorexant 20 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 20 mg suvorexant daily prior to bedtime during Treatment Period 2.
1009828|NCT00792298|P3|Participant Flow|Suvorexant 20 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 20 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
1009829|NCT00792298|P2|Participant Flow|Placebo → Suvorexant 10 mg|After an ~1- to 2-week single-blind placebo run-in period, participants received dose-matched placebo to suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by 10 mg suvorexant daily prior to bedtime during Treatment Period 2.
1009830|NCT00792298|P1|Participant Flow|Suvorexant 10 mg → Placebo|After an ~1- to 2-week single-blind placebo run-in period, participants received 10 mg suvorexant daily prior to bedtime for 4 weeks during Treatment Period 1, followed by a 1-week single-blind placebo washout period, followed by dose-matched placebo to suvorexant daily prior to bedtime during Treatment Period 2.
1009831|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
1009832|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
1009833|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
1009834|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
1009835|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over 4 weeks in Treatment Period 1.
1009836|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009837|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009838|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009839|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009840|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
1009841|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009842|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009843|NCT00792298|O3|Outcome|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009844|NCT00792298|O2|Outcome|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009845|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
1009846|NCT00792298|O5|Outcome|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009847|NCT00792298|O4|Outcome|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1010038|NCT00791700|O1|Outcome|Response|Participants with plasma HIV-1 RNA <48 copies/mL
1009850|NCT00792298|O1|Outcome|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
1009851|NCT00792298|E5|Reported Event|Suvorexant 80 mg|Participants received 80 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009852|NCT00792298|E4|Reported Event|Suvorexant 40 mg|Participants received 40 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009853|NCT00792298|E3|Reported Event|Suvorexant 20 mg|Participants received 20 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009854|NCT00792298|E2|Reported Event|Suvorexant 10 mg|Participants received 10 mg suvorexant daily prior to bedtime over a 4-week treatment period.
1009855|NCT00792298|E1|Reported Event|Placebo|Participants received dose-matched placebo to suvorexant daily prior to bedtime over a 4-week treatment period.
1009856|NCT00792259|B4|Baseline|Total|Total of all reporting groups
1009857|NCT00792259|B3|Baseline|Glaucoma Subjects|Glaucoma subjects presented with pathology
1009858|NCT00792259|B2|Baseline|Retinal Disease Subjects|Retinal Disease subjects with ocular pathology
1009859|NCT00792259|B1|Baseline|Normal Subjects|Normal Subjects with no known ocular pathology
1009860|NCT00792259|P3|Participant Flow|Glaucoma Subjects|Subjects presented with Glaucoma
1009861|NCT00792259|P2|Participant Flow|Normal Subjects|Normal subjects with no known ocular pathology
1009862|NCT00792259|P1|Participant Flow|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
1009863|NCT00792259|O3|Outcome|Glaucoma Subjects|Subjects presented with glaucoma
1009864|NCT00792259|O2|Outcome|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
1009865|NCT00792259|O1|Outcome|Normal Subjects|Normal subjects with no known ocular pathology
1009866|NCT00792259|E3|Reported Event|Glaucoma Subjects|Subjects presented with glaucoma
1009867|NCT00792259|E2|Reported Event|Normal Subjects|Normal subjects with no known ocular pathology
1009868|NCT00792259|E1|Reported Event|Retinal Disease Eyes|Retinal Disease subjects with ocular pathology
1009869|NCT00792116|B3|Baseline|Total|Total of all reporting groups
1009870|NCT00792116|B2|Baseline|Non-Gum Chewing|
1009871|NCT00792116|B1|Baseline|Gum Chewing|
1009872|NCT00792116|P2|Participant Flow|Non-Gum Chewing|
1009873|NCT00792116|P1|Participant Flow|Gum Chewing|
1009874|NCT00792116|O2|Outcome|Non-Gum Chewing|
1009875|NCT00792116|O1|Outcome|Gum Chewing|
1009876|NCT00792116|O2|Outcome|Non-Gum Chewing|
1009877|NCT00792116|O1|Outcome|Gum Chewing|
1009878|NCT00792116|O2|Outcome|Non-Gum Chewing|
1009879|NCT00792116|O1|Outcome|Gum Chewing|
1009880|NCT00792116|O2|Outcome|Non-Gum Chewing|
1009881|NCT00792116|O1|Outcome|Gum Chewing|
1009882|NCT00792103|B1|Baseline|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009883|NCT00792103|P1|Participant Flow|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009884|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009885|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009886|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009887|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009888|NCT00792103|O1|Outcome|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009889|NCT00792103|E1|Reported Event|NP101|The NP101 patch contained 86 mg of sumatriptan and was designed to deliver approximately 6.5 mg of sumatriptan over 4 hours. Patients were asked to use study patches to treat migraine episodes with moderate or severe headache pain for up to 12 months, during which they were permitted to apply (to the upper arms or thighs) a maximum of 6 patches within a 30-day period.
1009890|NCT00791999|B5|Baseline|Total|Total of all reporting groups
1009891|NCT00791999|B4|Baseline|Placebo|Placebo given every 2 weeks
1009892|NCT00791999|B3|Baseline|CDP870 400mg|400mg CDP870 given every 2 weeks
1009893|NCT00791999|B2|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
1009894|NCT00791999|B1|Baseline|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
1009895|NCT00791999|P4|Participant Flow|Placebo|Placebo given every 2 weeks
1009896|NCT00791999|P3|Participant Flow|CDP870 400mg|400mg CDP870 given every 2 weeks
1020871|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1009898|NCT00791999|P1|Participant Flow|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
1009899|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
1009900|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
1009901|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
1009902|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
1009903|NCT00791999|O4|Outcome|Placebo|Placebo given every 2 weeks
1009904|NCT00791999|O3|Outcome|CDP870 400mg|400mg CDP870 given every 2 weeks
1009905|NCT00791999|O2|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
1009906|NCT00791999|O1|Outcome|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
1009907|NCT00791999|E4|Reported Event|Placebo|Placebo given every 2 weeks
1009908|NCT00791999|E3|Reported Event|CDP870 400mg|400mg CDP870 given every 2 weeks
1009909|NCT00791999|E2|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2 weeks
1009910|NCT00791999|E1|Reported Event|CDP870 100mg|200mg CDP870 given at Week0, 2, 4 and thereafter 100mg CDP870 given every 2 weeks
1009911|NCT00791973|B3|Baseline|Total|Total of all reporting groups
1009912|NCT00791973|B2|Baseline|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
1009913|NCT00791973|B1|Baseline|Veramyst, Then Placbeo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
1009914|NCT00791973|P2|Participant Flow|Placebo, Then Veramyst|placebo nasal spray once daily (2 puffs/nostril) for a week, then one week washout period followed by fluticasone furoate (veramyst) nasal spray once daily (2 puffs/nostril) for a week
1009915|NCT00791973|P1|Participant Flow|Veramyst, Then Placebo|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week, then one week washout period followed by placebo nasal spray once daily , 2 puffs/nostril, for a week
1009916|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
1009917|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
1009918|NCT00791973|O2|Outcome|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
1009919|NCT00791973|O1|Outcome|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
1009920|NCT00791973|E2|Reported Event|Placebo|placebo nasal spray once daily (2 puffs/nostril) for a week
1009921|NCT00791973|E1|Reported Event|Veramyst|fluticasone furoate (Veramyst) nasal spray once daily, 2 puffs/nostril, for a week
1009922|NCT00791934|B1|Baseline|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
1009923|NCT00791934|P1|Participant Flow|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days.
1009924|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
1009925|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
1009926|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
1009927|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
1009928|NCT00791934|O1|Outcome|Stratus Microflow Ethmoid Spacer|Stratus Microflow Ethmoid Spacer: Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
1009929|NCT00791934|E1|Reported Event|Stratus Microflow Ethmoid Spacer|Temporary implantation of the Stratus Microflow Ethmoid Spacer in the ethmoid sinuses with triamcinolone acetonide for a period of 28 days
1009930|NCT00791921|B3|Baseline|Total|Total of all reporting groups
1009931|NCT00791921|B2|Baseline|Placebo|Placebo of CDP870
1009932|NCT00791921|B1|Baseline|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
1009933|NCT00791921|P2|Participant Flow|Placebo|Placebo of CDP870
1009934|NCT00791921|P1|Participant Flow|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
1009935|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
1009936|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
1009937|NCT00791921|O2|Outcome|Placebo|Placebo of CDP870
1009938|NCT00791921|O1|Outcome|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
1009939|NCT00791921|E2|Reported Event|Placebo|Placebo of CDP870
1009940|NCT00791921|E1|Reported Event|CDP870 200mg|400mg CDP870 given at Week0, 2, 4 and thereafter 200mg CDP870 given every 2weeks
1009941|NCT00791908|B1|Baseline|Subjects|
1009942|NCT00791908|P1|Participant Flow|Subjects|
1009943|NCT00791908|O3|Outcome|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
1009944|NCT00791908|O2|Outcome|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
1009945|NCT00791908|O1|Outcome|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
1009946|NCT00791908|E3|Reported Event|Pulsed-dye Laser (PDL)|Laser treatment applied to a third of the torso at each study visit.
1009947|NCT00791908|E2|Reported Event|KTP Laser|Laser treatment applied to a third of the torso at each study visit.
1009948|NCT00791908|E1|Reported Event|Electrodesiccation (ED)|Laser treatment applied to a third of the torso at each study visit.
1009949|NCT00791817|B3|Baseline|Total|Total of all reporting groups
1009950|NCT00791817|B2|Baseline|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
1009951|NCT00791817|B1|Baseline|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
1009952|NCT00791817|P2|Participant Flow|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
1009953|NCT00791817|P1|Participant Flow|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
1009954|NCT00791817|O2|Outcome|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
1009955|NCT00791817|O1|Outcome|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
1009956|NCT00791817|E2|Reported Event|200 mg PG 760564. Fasted|200 mg PG 760564. subjects dosed in a Fasted , followed by a washout period, followed by 200 mg PG 760564 in a Fed state
1009957|NCT00791817|E1|Reported Event|200 mg PG 760564. Fed Then Fasted|200 mg PG 760564. subjects dosed in a Fed State, followed by a washout period, followed by 200 mg PG 760564 in a fasted state
1009958|NCT00791778|B3|Baseline|Total|Total of all reporting groups
1009959|NCT00791778|B2|Baseline|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009960|NCT00791778|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009961|NCT00791778|P2|Participant Flow|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009962|NCT00791778|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009963|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009964|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009965|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009966|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009967|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009968|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009969|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009970|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009971|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009972|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009973|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009974|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009975|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009976|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009977|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009978|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009979|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009980|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009981|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009982|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009983|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009984|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009985|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009986|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009987|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009988|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009989|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009990|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009991|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009992|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009993|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009994|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009995|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009996|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009997|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1009998|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1009999|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1010000|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1010001|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1010002|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1010003|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1010004|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1010005|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1010006|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1010007|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1010008|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1010009|NCT00791778|O2|Outcome|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1010010|NCT00791778|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1010011|NCT00791778|E2|Reported Event|Placebo|Participants received 2 matching placebo tablets per oral twice daily
1010012|NCT00791778|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Participants received 2 sorafenib tablets (200 mg each) per oral twice daily (bid)
1010013|NCT00791765|B3|Baseline|Total|Total of all reporting groups
1010014|NCT00791765|B2|Baseline|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
1010015|NCT00791765|B1|Baseline|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
1010016|NCT00791765|P2|Participant Flow|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
1010017|NCT00791765|P1|Participant Flow|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
1010018|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
1010019|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
1010020|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
1010021|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
1010022|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
1010023|NCT00791765|O2|Outcome|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
1010024|NCT00791765|O1|Outcome|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
1010025|NCT00791765|E2|Reported Event|Etanercept 50 mg BIW/Etanercept 50 mg QW|Participants received etanercept 50 mg by subcutaneous injection twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg once per week (QW) and placebo once per week.
1010026|NCT00791765|E1|Reported Event|Placebo BIW/Etanercept 50 mg BIW|Participants received placebo subcutaneous injections twice per week (BIW) for the first 12 weeks of the study. From Week 12 to Week 24, participants received etanercept 50 mg BIW.
1010027|NCT00791700|B5|Baseline|Total|Total of all reporting groups
1010028|NCT00791700|B4|Baseline|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010029|NCT00791700|B3|Baseline|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010030|NCT00791700|B2|Baseline|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010031|NCT00791700|B1|Baseline|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010032|NCT00791700|P4|Participant Flow|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010033|NCT00791700|P3|Participant Flow|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010034|NCT00791700|P2|Participant Flow|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010035|NCT00791700|P1|Participant Flow|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010036|NCT00791700|O3|Outcome|Other Failure/Remainder|Participants with other failures
1010037|NCT00791700|O2|Outcome|PDVF|Participants who meet the protocol-defined virologic failure
1010039|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010040|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010041|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010042|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010043|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010044|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010045|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010046|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010047|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010048|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010049|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010050|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010051|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010052|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010053|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010054|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010055|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010056|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010057|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010058|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010059|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010060|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010061|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010062|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010063|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010064|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010065|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010066|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010067|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010068|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010069|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010070|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010071|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010072|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010073|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010074|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010075|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010076|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010077|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010078|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010079|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010080|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010081|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010082|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010083|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010084|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010085|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010086|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010087|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010133|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010088|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010089|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010090|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010091|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010092|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010093|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010094|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010095|NCT00791700|O8|Outcome|Cohort 4 (Grade 4)|>=12 - <18 years of age, MVC tablet formulation
1010096|NCT00791700|O7|Outcome|Cohort 4 (Grade 3)|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010097|NCT00791700|O6|Outcome|Cohort 3 (Grade 4)|>=6- <12years of age, MVC liquid formulation
1010098|NCT00791700|O5|Outcome|Cohort 3 (Grade 3)|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010099|NCT00791700|O4|Outcome|Cohort 2 (Grade 4)|>=6 - <12 years of age, MVC tablet formulation
1010100|NCT00791700|O3|Outcome|Cohort 2 (Grade 3)|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010101|NCT00791700|O2|Outcome|Cohort 1 (Grade 4)|>=2 - <6 years of age, MVC liquid formulation
1010102|NCT00791700|O1|Outcome|Cohort 1 (Grade 3)|>=2 - <6 years of age, MVC liquid formulation
1010103|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010104|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010105|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010106|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010107|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010108|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010109|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010110|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010111|NCT00791700|O4|Outcome|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010112|NCT00791700|O3|Outcome|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010113|NCT00791700|O2|Outcome|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010114|NCT00791700|O1|Outcome|>=2 - <6 Years of Age, MVC Liquid Formulation|In Cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010115|NCT00791700|E4|Reported Event|>=12 - <18 Years of Age, MVC Tablet Formulation|In Cohort 4, >=12 - <18 years of age, MVC tablet formulation
1010116|NCT00791700|E3|Reported Event|>=6 - <12 Years of Age, MVC Liquid Formulation|In Cohort 3, >=6 - <12 years of age, MVC liquid formulation
1010117|NCT00791700|E2|Reported Event|>=6 - <12 Years of Age, MVC Tablet Formulation|In Cohort 2, >=6 - <12 years of age, MVC tablet formulation
1010118|NCT00791700|E1|Reported Event|>=2 - <6 Years of Age, MVC Liquid Formulation|In cohort 1, >=2 - <6 years of age, MVC liquid formulation
1010119|NCT00791661|B4|Baseline|Total|Total of all reporting groups
1010120|NCT00791661|B3|Baseline|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
1010121|NCT00791661|B2|Baseline|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
1010122|NCT00791661|B1|Baseline|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
1010123|NCT00791661|P3|Participant Flow|Panel C: MK-1006 100/140/170|Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
1010124|NCT00791661|P2|Participant Flow|Panel B: MK-1006 60/80/60 Fed|Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
1010125|NCT00791661|P1|Participant Flow|Panel A: MK-1006 15/30/45|Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.
1010126|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
1010127|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
1010128|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010129|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010130|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010131|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010132|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010137|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
1010138|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
1010139|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010140|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010141|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010142|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010143|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010144|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010145|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010146|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010147|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010148|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010149|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010150|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010151|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010152|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010153|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010154|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010155|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010156|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010157|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010158|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010159|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010160|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010161|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010162|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010163|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010164|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010165|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010166|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010167|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010168|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010169|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010170|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010171|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010172|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010173|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010174|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010175|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010176|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010177|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010178|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010179|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010180|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010181|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010182|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010183|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010184|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010185|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010186|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010187|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010188|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010189|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010190|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010191|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010192|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010193|NCT00791661|O11|Outcome|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
1010194|NCT00791661|O10|Outcome|Placebo|Participants received matching placebo to MK-1006
1010195|NCT00791661|O9|Outcome|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010196|NCT00791661|O8|Outcome|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010197|NCT00791661|O7|Outcome|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010198|NCT00791661|O6|Outcome|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010199|NCT00791661|O5|Outcome|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010200|NCT00791661|O4|Outcome|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010201|NCT00791661|O3|Outcome|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010202|NCT00791661|O2|Outcome|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010203|NCT00791661|O1|Outcome|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010204|NCT00791661|E11|Reported Event|Placebo Fed|Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast
1010205|NCT00791661|E10|Reported Event|Placebo|Participants received matching placebo to MK-1006
1010206|NCT00791661|E9|Reported Event|MK-1006 170 mg|Participants received a single dose of MK-1006 170 mg
1010207|NCT00791661|E8|Reported Event|MK-1006 140 mg|Participants received a single dose of MK-1006 140 mg
1010208|NCT00791661|E7|Reported Event|MK-1006 100 mg|Participants received a single dose of MK-1006 100 mg
1010209|NCT00791661|E6|Reported Event|MK-1006 80 mg|Participants received a single dose of MK-1006 80 mg
1010210|NCT00791661|E5|Reported Event|MK-1006 60 mg Fed|Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast
1010211|NCT00791661|E4|Reported Event|MK-1006 60 mg|Participants received a single dose of MK-1006 60 mg
1010212|NCT00791661|E3|Reported Event|MK-1006 45 mg|Participants received a single dose of MK-1006 45 mg
1010213|NCT00791661|E2|Reported Event|MK-1006 30 mg|Participants received a single dose of MK-1006 30 mg
1010214|NCT00791661|E1|Reported Event|MK-1006 15 mg|Participants received a single dose of MK-1006 15 mg
1010215|NCT00791648|B3|Baseline|Total|Total of all reporting groups
1010216|NCT00791648|B2|Baseline|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010217|NCT00791648|B1|Baseline|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010218|NCT00791648|P2|Participant Flow|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010219|NCT00791648|P1|Participant Flow|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010220|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010221|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010222|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010223|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010224|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010225|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010226|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010227|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010228|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010229|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010230|NCT00791648|O2|Outcome|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010231|NCT00791648|O1|Outcome|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010232|NCT00791648|E2|Reported Event|Placebo|"placebo: Aim 1 control: placebo one day prior to cardiac surgery and daily thereafter until hospital discharge.~Aim 2 control: placebo the day of cardiac surgery and postop day 1."
1010233|NCT00791648|E1|Reported Event|Statin|"atorvastatin: Aim1 intervention: atorvastatin 80mg 1 day prior to open heart surgery and 40mg daily thereafter until hospital discharge.~Aim2 intervention: atorvastatin 80mg the day of cardiac surgery and 40mg on postop day 1."
1010234|NCT00791557|B1|Baseline|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
1010235|NCT00791557|P1|Participant Flow|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
1010236|NCT00791557|O1|Outcome|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
1010237|NCT00791557|E1|Reported Event|Infliximab|"Single arm open label~Infliximab : IV drug given at weeks 1,2,14,22"
1010317|NCT00791479|P5|Participant Flow|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010238|NCT00791518|B1|Baseline|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
1010239|NCT00791518|P1|Participant Flow|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
1010240|NCT00791518|O4|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
1010241|NCT00791518|O3|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
1010242|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
1010243|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and a an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
1010244|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
1010245|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
1010246|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
1010247|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
1010248|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=50%
1010249|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/-year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <50%
1010250|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 >=80%
1010251|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician with a post-albuterol FEV1 <80%
1010252|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 >=50%
1010253|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician and a post-albuterol FEV1 <50%
1010254|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
1010255|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
1010256|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
1010257|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <50%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <50%
1010258|NCT00791518|O2|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 >=80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 >=80%
1010259|NCT00791518|O1|Outcome|Participants With Diagnosed COPD and Post-albuterol FEV1 <80%|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician who also had a post-albuterol FEV1 <80%
1010260|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
1010261|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
1010262|NCT00791518|O1|Outcome|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
1010263|NCT00791518|E1|Reported Event|Participants With Diagnosed COPD|Current and previous smokers with at least a 10 pack/year history of cigarette smoking and an established history of chronic obstructive pulmonary disease (COPD) as diagnosed by a physician
1010264|NCT00791492|B3|Baseline|Total|Total of all reporting groups
1010265|NCT00791492|B2|Baseline|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010266|NCT00791492|B1|Baseline|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010267|NCT00791492|P2|Participant Flow|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010268|NCT00791492|P1|Participant Flow|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010269|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010270|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010271|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010272|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010273|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010274|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010275|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010276|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010277|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010278|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010279|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010280|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010281|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010282|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010283|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010284|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010285|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010286|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010287|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010318|NCT00791479|P4|Participant Flow|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010288|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010289|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010290|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010291|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010292|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010293|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010294|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010295|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010296|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010297|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010298|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010299|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010300|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010301|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010302|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010303|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010304|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010305|NCT00791492|O2|Outcome|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010306|NCT00791492|O1|Outcome|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010307|NCT00791492|E2|Reported Event|Placebo-Tafamidis|Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010308|NCT00791492|E1|Reported Event|Tafamidis-Tafamidis|Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months.
1010309|NCT00791479|B7|Baseline|Total|Total of all reporting groups
1010310|NCT00791479|B6|Baseline|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010311|NCT00791479|B5|Baseline|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010312|NCT00791479|B4|Baseline|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010313|NCT00791479|B3|Baseline|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010314|NCT00791479|B2|Baseline|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010315|NCT00791479|B1|Baseline|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010316|NCT00791479|P6|Participant Flow|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010319|NCT00791479|P3|Participant Flow|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010320|NCT00791479|P2|Participant Flow|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010321|NCT00791479|P1|Participant Flow|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010322|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010323|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010324|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010325|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010326|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010327|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010328|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010329|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010330|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010331|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010332|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010333|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010334|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010335|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010336|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010337|NCT00791479|O6|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010338|NCT00791479|O5|Outcome|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010339|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010340|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010341|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010342|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010343|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010344|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010345|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010346|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010347|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010348|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010349|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010350|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010351|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010352|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010353|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010354|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010355|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010356|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1011004|NCT00790023|O2|Outcome|160 mcg Ciclesonide|160 mcg Ciclesonide once daily
1010357|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010358|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010359|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010360|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010361|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010362|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010363|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010364|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010365|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010366|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010367|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010368|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010369|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010370|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010371|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010372|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010373|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010374|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010375|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010376|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010377|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010378|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010379|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010380|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010381|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010382|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010383|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010384|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010385|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010386|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010387|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010388|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010389|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010390|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010391|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010392|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010393|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010394|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010395|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010396|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010397|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
1010398|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010399|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010400|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010401|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010402|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010403|NCT00791479|O5|Outcome|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
1010404|NCT00791479|O4|Outcome|1.5 Milligrams (mg) LY2189265|LY2189265 1.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
1010405|NCT00791479|O3|Outcome|1.0 Milligrams (mg) LY2189265|LY2189265 1.0 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
1010406|NCT00791479|O2|Outcome|0.5 Milligrams (mg) LY2189265|LY2189265 0.5 milligram (mg): subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
1010407|NCT00791479|O1|Outcome|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with lifestyle measures for up to 12 weeks
1010408|NCT00791479|E6|Reported Event|Placebo|Placebo: subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010409|NCT00791479|E5|Reported Event|3.0 Milligrams (mg) LY2189265|LY2189265: 3.0 milligram (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010410|NCT00791479|E4|Reported Event|1.5 Milligrams (mg) LY2189265|LY2189265: 1.5 milligrams (mg) subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010411|NCT00791479|E3|Reported Event|1.0 Milligrams (mg) LY2189265|LY2189265: 1.0 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010412|NCT00791479|E2|Reported Event|0.5 Milligrams (mg) LY2189265|LY2189265: 0.5 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010413|NCT00791479|E1|Reported Event|0.1 Milligrams (mg) LY2189265|LY2189265: 0.1 milligrams (mg), subcutaneous (SC) injection, once weekly (QW), along with life style changes for up to 12 weeks
1010414|NCT00791388|B6|Baseline|Total|Total of all reporting groups
1010415|NCT00791388|B5|Baseline|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
1010416|NCT00791388|B4|Baseline|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
1010417|NCT00791388|B3|Baseline|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
1010418|NCT00791388|B2|Baseline|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
1010419|NCT00791388|B1|Baseline|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
1010420|NCT00791388|P5|Participant Flow|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
1010421|NCT00791388|P4|Participant Flow|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
1010422|NCT00791388|P3|Participant Flow|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
1010423|NCT00791388|P2|Participant Flow|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
1010424|NCT00791388|P1|Participant Flow|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
1010425|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
1010426|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
1010427|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
1010428|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
1010429|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
1010430|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
1010431|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
1010432|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
1010433|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
1010434|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
1010435|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
1010436|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
1010437|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
1010438|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
1010439|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
1010440|NCT00791388|O5|Outcome|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
1010441|NCT00791388|O4|Outcome|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
1010442|NCT00791388|O3|Outcome|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
1010443|NCT00791388|O2|Outcome|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
1010444|NCT00791388|O1|Outcome|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
1010445|NCT00791388|E5|Reported Event|400 mg PG 760564|400 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 400mg dose group, then proceed to subsequent groups)
1010446|NCT00791388|E4|Reported Event|200 mg PG 760564|200 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 200mg dose group, then proceed to subsequent groups)
1010447|NCT00791388|E3|Reported Event|100 mg PG 760564|100 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 100mg dose group, then proceed to subsequent groups)
1010448|NCT00791388|E2|Reported Event|50 mg PG 760564|50 mg PG 760564 Administered Twice for 14 Days (27 Doses). Subjects enrolled in this period participated in one period only (e.g., subjects did not start in the 50mg dose group, then proceed to subsequent groups)
1010449|NCT00791388|E1|Reported Event|Placebo|placebo capsule. This study consisted of 4 sequential periods testing rising doses of PG 760564. Each period randomized participants to receive either placebo or a specific dose of PG 760564. Subjects enrolled in a period participated in that period only.
1010450|NCT00791323|B3|Baseline|Total|Total of all reporting groups
1010451|NCT00791323|B2|Baseline|Soothe® XP|Mineral Oil Emollient
1010452|NCT00791323|B1|Baseline|Ketorolac 0.4%|Ketorolac 0.4%
1010453|NCT00791323|P2|Participant Flow|Soothe® XP|Mineral Oil Emollient
1010454|NCT00791323|P1|Participant Flow|Ketorolac 0.4%|Ketorolac 0.4%
1010455|NCT00791323|O2|Outcome|Soothe® XP|Mineral Oil Emollient
1010456|NCT00791323|O1|Outcome|Ketorolac 0.4%|Ketorolac 0.4%
1010457|NCT00791323|E2|Reported Event|Soothe® XP|Mineral Oil Emollient
1010458|NCT00791323|E1|Reported Event|Ketorolac 0.4%|Ketorolac 0.4%
1010459|NCT00791258|B1|Baseline|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010460|NCT00791258|P1|Participant Flow|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010461|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1020872|NCT00766415|O1|Outcome|AZD1981|AZD1981 1000 mg, twice daily
1010462|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010463|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010464|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010465|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010466|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010467|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010468|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010469|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010470|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010471|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010472|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010473|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010474|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010475|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010476|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010477|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010478|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010479|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010480|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010481|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010482|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010483|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010484|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010485|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010486|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010487|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010488|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010489|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010611|NCT00790790|O2|Outcome|Compound 645838 (CLm)|Plasma Compound 645838 concentrations were obtained following daily oral doses of LY545694 21 mg to 105 mg.
1010490|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010491|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010492|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010493|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010494|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010495|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010496|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010497|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010498|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010499|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010500|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010501|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010502|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010503|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010504|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010505|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010506|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010507|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010508|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010509|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010510|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010511|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010512|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010513|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010514|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010515|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010516|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010517|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010612|NCT00790790|O1|Outcome|LY545694 Clearance (CLp)|Plasma LY545694 concentrations were obtained following daily oral doses of LY545694 21 mg to LY545694 105 mg.
1010518|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010519|NCT00791258|O1|Outcome|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010520|NCT00791258|E1|Reported Event|Olmesartan Medoxomil/Amlodipine Tablets + Hydrochlorothiazide|Amlodipine and olmesartan medoxomil (Azor) oral tablets and hydrochlorothiazide oral tablets (if necessary) will be administered once a day for up to 20 weeks
1010521|NCT00791128|B1|Baseline|EndoBarrier Liner Device|Subjects implanted with the EndoBarrier for up to 12 months.
1010522|NCT00791128|P1|Participant Flow|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
1010523|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
1010524|NCT00791128|O1|Outcome|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
1010525|NCT00791128|E1|Reported Event|EndoBarrier|Subjects implanted with the EndoBarrier for up to 12 months.
1010526|NCT00791102|B1|Baseline|All Study Participants|
1010527|NCT00791102|P2|Participant Flow|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010528|NCT00791102|P1|Participant Flow|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010529|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010530|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010531|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010532|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010533|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010534|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010535|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010536|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010537|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010538|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010539|NCT00791102|O2|Outcome|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010540|NCT00791102|O1|Outcome|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010541|NCT00791102|E2|Reported Event|Placebo for Topical ASP-1001|"Placebo for Topical ASP-1001~Placebo for ASP-1001 : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010542|NCT00791102|E1|Reported Event|Topical ASP-1001|"Topical ASP-1001~ASP-1001 nasal spray : 2 sprays (total 200 microliters) in each nostril 20 minutes before allergen challenge."
1010543|NCT00791089|B3|Baseline|Total|Total of all reporting groups
1010544|NCT00791089|B2|Baseline|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
1010545|NCT00791089|B1|Baseline|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
1010546|NCT00791089|P2|Participant Flow|Placebo, Ablation, Sinus Rhythm|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
1010547|NCT00791089|P1|Participant Flow|Fish Oil, Ablation, Sinus Rhythm|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
1010548|NCT00791089|O2|Outcome|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
1010549|NCT00791089|O1|Outcome|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
1010550|NCT00791089|E2|Reported Event|Placebo, Ablation|"Patients in the control arm will not receive any omega-3 fatty acids. However they will receive placebo.~placebo: Control group will receive placebo before & after ablation."
1010635|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010551|NCT00791089|E1|Reported Event|Fish Oil, Ablation|"Patients in the treatment arm will receive omega-3 fatty acids (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure.~LOVAZA Omega 3-acid ethyl esters: Treatment with omega-3 fatty acids (4g/day) for 4 weeks before and 3 months after radiofrequency catheter ablation for AF.~LOVAZA: (EPA+DHA 4 gram/day) for 4 weeks before and 3 months after the ablation procedure."
1010552|NCT00791037|B1|Baseline|Treatment (Vaccine Therapy+ex Vivo T Cell Expansion)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
1010553|NCT00791037|P1|Participant Flow|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
1010554|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
1010555|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
1010556|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
1010557|NCT00791037|O1|Outcome|Treatment (Vaccine Therapy+ex Vivo-expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
1010558|NCT00791037|E1|Reported Event|Treatment (Vaccine Therapy+ex Vivo Expanded T Cells)|"Patients receive HER2/neu peptide vaccine admixed with sargramostim (GM-CSF) ID on days 1, 8, and 15. Beginning 2 weeks later, patients undergo leukapheresis to isolate and collect peripheral blood mononuclear cells for T-cell expansion.~Patients receive cyclophosphamide IV once on day -1 and autologous ex vivo-expanded HER2-specific T cell IV over 30 minutes on day 1. Treatment repeats every 7-10 days for up to three immunizations. Patients receive a booster HER2/neu peptide vaccine 1 month after the final T-cell infusion, followed by 2 additional booster vaccines at 2-month intervals.~HER-2/neu peptide vaccine: Given ID~leukapheresis: Undergo leukapheresis~ex vivo-expanded HER2-specific T cells: Given IV~cyclophosphamide: Given IV~sargramostim: Given ID~laboratory biomarker analysis: Correlative study"
1010559|NCT00790907|B4|Baseline|Total|Total of all reporting groups
1010560|NCT00790907|B3|Baseline|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010636|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010695|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
1010561|NCT00790907|B2|Baseline|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010562|NCT00790907|B1|Baseline|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
1010563|NCT00790907|P3|Participant Flow|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010564|NCT00790907|P2|Participant Flow|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010565|NCT00790907|P1|Participant Flow|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
1010566|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010567|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010568|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010569|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010570|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010571|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010608|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1020873|NCT00766415|O2|Outcome|Placebo|Placebo, twice daily
1010572|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010573|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010574|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010575|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010576|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010577|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010578|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010579|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010580|NCT00790907|O2|Outcome|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010581|NCT00790907|O1|Outcome|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010609|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010610|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010582|NCT00790907|E3|Reported Event|OL Fondaparinux Background + Standard Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded standard dose UFH (based on planned GPIIb/IIIa inhibitor use: 60 U/kg; no planned use: 85 U/kg and adjusted based on ACT [maximum two additional bolus doses]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of UA/NSTEMI may have been considered for randomization.
1010583|NCT00790907|E2|Reported Event|OL Fondaparinux Background + Low Dose UFH During PCI|OL fondaparinux syringes pre-filled with 2.5 mg, administered s.c. once daily for up to 8 days or hospital discharge, whichever was earlier. Participants indicated for PCI were randomized to receive adjunctive blinded low-dose unfractionated heparin (UFH) (50 units/kilogram [U/kg], which was not adjusted for planned glycoprotein [GP] IIb/IIIa use or activated clotting time [ACT]). Participants who presented in the catheterization laboratory and who were receiving commercially available fondaparinux prescribed for the initial treatment of unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) may have been considered for randomization.
1010584|NCT00790907|E1|Reported Event|Open-label Fondaparinux 2.5 mg|Open-label (OL) fondaparinux syringes pre-filled with 2.5 milligrams (mg), administered subcutaneously (s.c.) once daily for up to 8 days or hospital discharge, whichever was earlier, for those participants not indicated for percutaneous coronary intervention (PCI) and not randomized
1010585|NCT00790855|B1|Baseline|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
1010586|NCT00790855|P1|Participant Flow|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
1010587|NCT00790855|O1|Outcome|Bendamustine (75 mg/m^2)|75 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
1010588|NCT00790855|O1|Outcome|Bendamustine|Starting dose 50 mg/m^2 intravenously, over 2 hours twice on Days 1-4 of every 4 week study cycle, with dose escalation of 25 mg/m^2 for 3 levels.
1010589|NCT00790855|E1|Reported Event|Bendamustine|Starting dose 50 mg/m^2 intravenously over 2 hours twice on Days 1-4 of every 4 week study cycle.
1010590|NCT00790803|B1|Baseline|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010591|NCT00790803|P1|Participant Flow|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010592|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010593|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010594|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010595|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010596|NCT00790803|O1|Outcome|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010597|NCT00790803|E1|Reported Event|Macugen|"Single arm pilot trial~Pegaptanib (Macugen) : Five patients will receive intravitreous injections of Macugen 0.3 mg every 6 weeks as needed for a total of no more than five."
1010598|NCT00790790|B4|Baseline|Total|Total of all reporting groups
1010599|NCT00790790|B3|Baseline|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010600|NCT00790790|B2|Baseline|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010601|NCT00790790|B1|Baseline|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010602|NCT00790790|P3|Participant Flow|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010603|NCT00790790|P2|Participant Flow|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010604|NCT00790790|P1|Participant Flow|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010605|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010606|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010607|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010613|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010614|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010615|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010616|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010617|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010618|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010619|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010620|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010621|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010622|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010623|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010624|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010625|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010626|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010627|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010628|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010629|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010630|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010631|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010632|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010633|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010634|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010637|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010638|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010639|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010640|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010641|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010642|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010643|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010644|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010645|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010646|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010647|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010648|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010649|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010650|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010651|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010652|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010653|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010654|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010655|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010656|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010657|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010658|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010659|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010660|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010661|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010662|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010663|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010664|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010665|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010666|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010667|NCT00790790|O3|Outcome|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010668|NCT00790790|O2|Outcome|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010669|NCT00790790|O1|Outcome|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010670|NCT00790790|E6|Reported Event|LY545694 105 mg Washout|1 week washout period from taking 105 mg LY545694
1010671|NCT00790790|E5|Reported Event|LY545694 49 mg Washout|1 week washout period from taking 49 mg LY545694
1010672|NCT00790790|E4|Reported Event|Placebo Washout|1 week washout period from taking placebo
1010673|NCT00790790|E3|Reported Event|LY545694 105 mg|Participants randomized to LY545694 105 mg BID po were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. At Visit 5, participants were titrated to the final dose of LY545694 105 mg BID po. Participants who were intolerant of this dose were titrated back down to LY545694 49 mg BID po for the remainder of study treatment.
1010674|NCT00790790|E2|Reported Event|LY545694 49 mg|Participants randomized to LY545694 49 milligrams (mg) twice daily (BID) oral (po) were first administered LY545694 21 mg BID po at Visit 3. After 1 week of dosing, participants were escalated to LY545694 49 mg BID po at Visit 4. Participants who were intolerant of this dose were titrated back down to 21 mg BID po for the remainder of study treatment.
1010675|NCT00790790|E1|Reported Event|Placebo|Participants randomized to LY545694 placebo were given LY545694 placebo twice daily (BID) oral (po) for 5 weeks.
1010676|NCT00790751|B5|Baseline|Total|Total of all reporting groups
1010677|NCT00790751|B4|Baseline|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1010678|NCT00790751|B3|Baseline|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1010679|NCT00790751|B2|Baseline|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
1010680|NCT00790751|B1|Baseline|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1010681|NCT00790751|P4|Participant Flow|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1010682|NCT00790751|P3|Participant Flow|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1010683|NCT00790751|P2|Participant Flow|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
1010684|NCT00790751|P1|Participant Flow|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1010685|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1010686|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1010687|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
1010688|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1010689|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1010690|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1010691|NCT00790751|O2|Outcome|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
1010692|NCT00790751|O1|Outcome|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1010693|NCT00790751|O4|Outcome|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1010694|NCT00790751|O3|Outcome|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1010697|NCT00790751|E4|Reported Event|Avanafil 200 mg|avanafil 200 mg 30 minutes orally prior to initiation of sexual activity
1010698|NCT00790751|E3|Reported Event|Avanafil 100 mg|avanafil 100 mg 30 minutes orally prior to initiation of sexual activity
1010699|NCT00790751|E2|Reported Event|Avanafil 50 mg|avanafil 50 mg 30 minutes orally prior to initiation of sexual activity
1010700|NCT00790751|E1|Reported Event|Placebo|placebo 30 minutes orally prior to initiation of sexual activity
1010701|NCT00790738|B3|Baseline|Total|Total of all reporting groups
1010702|NCT00790738|B2|Baseline|Placebo|"placebo~placebo: placebo"
1010703|NCT00790738|B1|Baseline|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
1010704|NCT00790738|P2|Participant Flow|Placebo|"placebo~placebo: placebo"
1010705|NCT00790738|P1|Participant Flow|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
1010706|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
1010707|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
1010708|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
1010709|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
1010710|NCT00790738|O2|Outcome|Placebo|"placebo~placebo: placebo"
1010711|NCT00790738|O1|Outcome|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (thyroid hormone T3) up to 50 micrograms a day."
1010712|NCT00790738|E2|Reported Event|Placebo|"placebo~placebo: placebo"
1010713|NCT00790738|E1|Reported Event|Liothyronine (T3)|"liothyronine (T3)~Liothyronine (T3): liothyronine (T3) up to 50 micrograms a day"
1010714|NCT00790673|B5|Baseline|Total|Total of all reporting groups
1010715|NCT00790673|B4|Baseline|Placebo|Placebo: Matching placebo capsules
1010716|NCT00790673|B3|Baseline|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
1010717|NCT00790673|B2|Baseline|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
1010718|NCT00790673|B1|Baseline|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
1010719|NCT00790673|P4|Participant Flow|Placebo|Placebo: Matching placebo capsules
1010720|NCT00790673|P3|Participant Flow|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
1010721|NCT00790673|P2|Participant Flow|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
1010722|NCT00790673|P1|Participant Flow|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
1010723|NCT00790673|O4|Outcome|Placebo|Placebo: Matching placebo capsules
1010724|NCT00790673|O3|Outcome|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
1010725|NCT00790673|O2|Outcome|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
1010726|NCT00790673|O1|Outcome|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
1010727|NCT00790673|E4|Reported Event|Placebo|Placebo: Matching placebo capsules
1010728|NCT00790673|E3|Reported Event|Cohort 3 CF102 1 mg Bid|"CF102 1 mg bid; 16 weeks~CF 102: Oral capsules"
1010729|NCT00790673|E2|Reported Event|Cohort 2 CF102 1 mg Bid|"CF102 1 mg bid~CF 102: Oral capsules"
1010730|NCT00790673|E1|Reported Event|Cohort 1 CF102 1 mg qd|"CF102 1 mg qd~CF 102: Oral capsules"
1010731|NCT00790647|B1|Baseline|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
1010732|NCT00790647|P1|Participant Flow|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
1010733|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
1010734|NCT00790647|O1|Outcome|Stem Cell Transplantation With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
1010735|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collection through day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
1010736|NCT00790647|O1|Outcome|Stem Cell Transplant With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before Stem Cell Collectionthrough day before final Stem Cell Collection~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
1010737|NCT00790647|E1|Reported Event|SCT With Bortezomib and Melphalan|"Mobilization with Filgrastim Stem Cell Collection (SCC) Bortezomib Melphalan Stem Cell infusion~filgrastim: 16 mcg/kg daily beginning 3 days before SCC through day before final SCC~bortezomib: 1.0 mg/m2/dose D –6, D-3, D +1, D + 4~melphalan: 100 mg/m2/dose D –2, D –1~Stem Cell Infusion: infusion of previously collected autologous stem cells"
1010738|NCT00790569|B4|Baseline|Total|Total of all reporting groups
1010739|NCT00790569|B3|Baseline|Ar